id|nct_id|ctgov_group_code|result_type|title|description
2025|NCT03489551|B1|Baseline|Oral Haldol in Patients Undergoing HSCT|"Prior to stem cell transplant participants will receive 5mg of liquid or pill form, oral Haldol. Every other day visits will take place following the first administration of the study drug until 14 days after the transplant.~Haldol"
2026|NCT03489551|P1|Participant Flow|Oral Haldol in Patients Undergoing HSCT|"Prior to stem cell transplant participants will receive 5mg of liquid or pill form, oral Haldol. Every other day visits will take place following the first administration of the study drug until 14 days after the transplant.~Haldol"
2027|NCT03489551|O1|Outcome|Oral Haldol in Patients Undergoing HSCT|"Prior to stem cell transplant participants will receive 5mg of liquid or pill form, oral Haldol. Every other day visits will take place following the first administration of the study drug until 14 days after the transplant.~Haldol"
2028|NCT03489551|E1|Reported Event|Oral Haldol in Patients Undergoing HSCT|"Prior to stem cell transplant participants will receive 5mg of liquid or pill form, oral Haldol. Every other day visits will take place following the first administration of the study drug until 14 days after the transplant.~Haldol"
2029|NCT03405818|B1|Baseline|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2030|NCT03405818|P1|Participant Flow|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2031|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2032|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2033|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2034|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2035|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2036|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2037|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2038|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2039|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2040|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2041|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2042|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2043|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2044|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2045|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2046|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2047|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2048|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2049|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2050|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2051|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2052|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2053|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2054|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2055|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2056|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2057|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2190|NCT03256552|O2|Outcome|GP MDI 14.4 µg|Glycopyrronium 14.4 µg
2191|NCT03256552|O1|Outcome|GP MDI 28.8 µg|Glycopyrronium MDI 28.8 µg
2058|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2059|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2060|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2061|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2062|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2063|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2064|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2065|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2066|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2067|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2068|NCT03405818|O1|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2069|NCT03405818|E1|Reported Event|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
2070|NCT03363633|B1|Baseline|All Arms|Participants were randomized to either compression stockings or perforator vein injection with sodium tetradecyl sulfate, plus compression stockings.
2071|NCT03363633|P1|Participant Flow|All Arms|Participants were randomized to either compression stockings or perforator vein injection with sodium tetradecyl sulfate, plus compression stockings.
2072|NCT03363633|O1|Outcome|All Arms|Participants were randomized to either compression stockings or perforator vein injection with sodium tetradecyl sulfate, plus compression stockings.
2073|NCT03363633|O1|Outcome|All Arms|Participants were randomized to either compression stockings or perforator vein injection with sodium tetradecyl sulfate, plus compression stockings.
2074|NCT03363633|O1|Outcome|All Arms|Participants were randomized to either compression stockings or perforator vein injection with sodium tetradecyl sulfate, plus compression stockings.
2075|NCT03363633|O1|Outcome|All Arms|Participants were randomized to either compression stockings or perforator vein injection with sodium tetradecyl sulfate, plus compression stockings.
2076|NCT03363633|O1|Outcome|All Arms|Participants were randomized to either compression stockings or perforator vein injection with sodium tetradecyl sulfate, plus compression stockings.
2077|NCT03363633|E1|Reported Event|All Arms|Participants were randomized to either compression stockings or perforator vein injection with sodium tetradecyl sulfate, plus compression stockings.
2078|NCT03350724|B3|Baseline|Total|Total of all reporting groups
2079|NCT03350724|B2|Baseline|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2080|NCT03350724|B1|Baseline|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2081|NCT03350724|P2|Participant Flow|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2082|NCT03350724|P1|Participant Flow|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2083|NCT03350724|O2|Outcome|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2084|NCT03350724|O1|Outcome|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2085|NCT03350724|O2|Outcome|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2086|NCT03350724|O1|Outcome|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2087|NCT03350724|O2|Outcome|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2088|NCT03350724|O1|Outcome|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2089|NCT03350724|O2|Outcome|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2090|NCT03350724|O1|Outcome|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2091|NCT03350724|O2|Outcome|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2192|NCT03256552|O4|Outcome|Placebo MDI|Placebo MDI
2092|NCT03350724|O1|Outcome|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2093|NCT03350724|O2|Outcome|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2094|NCT03350724|O1|Outcome|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2095|NCT03350724|O2|Outcome|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2096|NCT03350724|O1|Outcome|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2097|NCT03350724|O2|Outcome|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2098|NCT03350724|O1|Outcome|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2099|NCT03350724|O2|Outcome|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2100|NCT03350724|O1|Outcome|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2101|NCT03350724|O2|Outcome|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2102|NCT03350724|O1|Outcome|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2103|NCT03350724|O2|Outcome|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2104|NCT03350724|O1|Outcome|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2105|NCT03350724|O2|Outcome|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2106|NCT03350724|O1|Outcome|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2107|NCT03350724|O2|Outcome|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2108|NCT03350724|O1|Outcome|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2109|NCT03350724|O2|Outcome|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2110|NCT03350724|O1|Outcome|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2111|NCT03350724|O2|Outcome|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2112|NCT03350724|O1|Outcome|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2113|NCT03350724|O2|Outcome|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2114|NCT03350724|O1|Outcome|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2115|NCT03350724|O2|Outcome|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2116|NCT03350724|O1|Outcome|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2117|NCT03350724|O2|Outcome|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2118|NCT03350724|O1|Outcome|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2119|NCT03350724|O2|Outcome|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2120|NCT03350724|O1|Outcome|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2121|NCT03350724|O2|Outcome|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2193|NCT03256552|O3|Outcome|GP MDI 7.2 µg|Glycopyrronium 7.2 µg
2122|NCT03350724|O1|Outcome|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2123|NCT03350724|O2|Outcome|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2124|NCT03350724|O1|Outcome|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2125|NCT03350724|O2|Outcome|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2126|NCT03350724|O1|Outcome|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2127|NCT03350724|O2|Outcome|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2128|NCT03350724|O1|Outcome|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2129|NCT03350724|O2|Outcome|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2130|NCT03350724|O1|Outcome|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2131|NCT03350724|O2|Outcome|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2132|NCT03350724|O1|Outcome|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2133|NCT03350724|E2|Reported Event|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
2134|NCT03350724|E1|Reported Event|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
2135|NCT03349099|B3|Baseline|Total|Total of all reporting groups
2136|NCT03349099|B2|Baseline|Boston Scientific Navigator HD|"ureteral access sheath~Boston Scientific Navigator: ureteral access sheath"
2137|NCT03349099|B1|Baseline|Cook Flexor|"ureteral access sheath~Cook Flexor: ureteral access sheath"
2138|NCT03349099|P2|Participant Flow|Boston Scientific Navigator HD|"ureteral access sheath~Boston Scientific Navigator: ureteral access sheath"
2139|NCT03349099|P1|Participant Flow|Cook Flexor|"ureteral access sheath~Cook Flexor: ureteral access sheath"
2140|NCT03349099|O2|Outcome|Boston Scientific Navigator HD|"ureteral access sheath~Boston Scientific Navigator: ureteral access sheath"
2141|NCT03349099|O1|Outcome|Cook Flexor|"ureteral access sheath~Cook Flexor: ureteral access sheath"
2142|NCT03349099|O2|Outcome|Boston Scientific Navigator HD|"ureteral access sheath~Boston Scientific Navigator: ureteral access sheath"
2143|NCT03349099|O1|Outcome|Cook Flexor|"ureteral access sheath~Cook Flexor: ureteral access sheath"
2144|NCT03349099|O2|Outcome|Boston Scientific Navigator HD|"ureteral access sheath~Boston Scientific Navigator: ureteral access sheath"
2145|NCT03349099|O1|Outcome|Cook Flexor|"ureteral access sheath~Cook Flexor: ureteral access sheath"
2146|NCT03349099|E2|Reported Event|Boston Scientific Navigator HD|"ureteral access sheath~Boston Scientific Navigator: ureteral access sheath"
2147|NCT03349099|E1|Reported Event|Cook Flexor|"ureteral access sheath~Cook Flexor: ureteral access sheath"
2148|NCT03292692|B3|Baseline|Total|Total of all reporting groups
2149|NCT03292692|B2|Baseline|Waitlist Control|2 month waiting period before couples can receive intervention
2150|NCT03292692|B1|Baseline|OurRelationship|"Online Intervention~OurRelationship: Online intervention with coach support"
2151|NCT03292692|P2|Participant Flow|Waitlist Control|2 month waiting period before couples can receive intervention
2152|NCT03292692|P1|Participant Flow|OurRelationship|"Online Intervention~OurRelationship: Online intervention with coach support"
2153|NCT03292692|O2|Outcome|Waitlist Control|2 month waiting period before couples can receive intervention
2154|NCT03292692|O1|Outcome|OurRelationship|"Online Intervention~OurRelationship: Online intervention with coach support"
2155|NCT03292692|O2|Outcome|Waitlist Control|2 month waiting period before couples can receive intervention
2156|NCT03292692|O1|Outcome|OurRelationship|"Online Intervention~OurRelationship: Online intervention with coach support"
2157|NCT03292692|O2|Outcome|Waitlist Control|2 month waiting period before couples can receive intervention
2158|NCT03292692|O1|Outcome|OurRelationship|"Online Intervention~OurRelationship: Online intervention with coach support"
2159|NCT03292692|O2|Outcome|Waitlist Control|2 month waiting period before couples can receive intervention
2160|NCT03292692|O1|Outcome|OurRelationship|"Online Intervention~OurRelationship: Online intervention with coach support"
2161|NCT03292692|E2|Reported Event|Waitlist Control|2 month waiting period before couples can receive intervention
2162|NCT03292692|E1|Reported Event|OurRelationship|"Online Intervention~OurRelationship: Online intervention with coach support"
2163|NCT03271424|B4|Baseline|Total|Total of all reporting groups
2194|NCT03256552|O2|Outcome|GP MDI 14.4 µg|Glycopyrronium 14.4 µg
2195|NCT03256552|O1|Outcome|GP MDI 28.8 µg|Glycopyrronium MDI 28.8 µg
2196|NCT03256552|E4|Reported Event|Placebo MDI|Placebo MDI
2197|NCT03256552|E3|Reported Event|GP MDI 7.2 µg|Glycopyrronium 7.2 µg
2164|NCT03271424|B3|Baseline|In Clinic Observation-Subject Choice|"20 young women and 20 young men were assigned and conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice~Oraquick HIV Self Test - Choice: This is an oral swab in home HIV test.~Atomo HIV Self Test - Choice: This is a blood finger prick in home HIV test."
2165|NCT03271424|B2|Baseline|In Clinic Observation-Both|"10 young women and 10 young men were assigned and conducted BOTH of the HIV self-tests. Participants tried two different self-testing kits, one that is oral fluid based (saliva), Oraquick HIV Self Test, and one that is blood based via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test and Atomo HIV Self Test - Both~Oraquick HIV Self Test and Atomo HIV Self Test - Both: This is an oral swab in home HIV test and this is a blood finger prick in home HIV test."
2166|NCT03271424|B1|Baseline|Focus Group Discussions|Focus group discussions (FGD) with young women (n=2 FGDs) and young men (n=2 FGDs) in the study area to determine the best way to offer self-testing to study participants.
2167|NCT03271424|P3|Participant Flow|In Clinic Observation-Subject Choice|"20 young women and 20 young men were assigned and conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice~Oraquick HIV Self Test - Choice: This is an oral swab in home HIV test.~Atomo HIV Self Test - Choice: This is a blood finger prick in home HIV test."
2168|NCT03271424|P2|Participant Flow|Focus Group Discussions|Focus group discussions (FGD) with young women (n=2 FGDs) and young men (n=2 FGDs) in the study area to determine the best way to offer self-testing to study participants.
2169|NCT03271424|P1|Participant Flow|In Clinic Observation-Both|"10 young women and 10 young men were assigned and conducted BOTH of the HIV self-tests. Participants tried two different self-testing kits, one that is oral fluid based (saliva), Oraquick HIV Self Test, and one that is blood based via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test and Atomo HIV Self Test - Both~Oraquick HIV Self Test and Atomo HIV Self Test - Both: This is an oral swab in home HIV test and this is a blood finger prick in home HIV test."
2170|NCT03271424|O4|Outcome|In Clinic Observation-Subject Choice (Atomo Results)|"20 young women and 20 young men conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice~Oraquick HIV Self Test - Choice: This is an oral swab in home HIV test.~Atomo HIV Self Test - Choice: This is a blood finger prick in home HIV test."
2171|NCT03271424|O3|Outcome|In Clinic Observation-Subject Choice (Oraquick Results)|"20 young women and 20 young men conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice~Oraquick HIV Self Test - Choice: This is an oral swab in home HIV test.~Atomo HIV Self Test - Choice: This is a blood finger prick in home HIV test."
2172|NCT03271424|O2|Outcome|In Clinic Observation - Both (Atomo Results)|"10 young women and 10 young men were assigned and conducted BOTH of the HIV self-tests. Participants tried two different self-testing kits, one that is oral fluid based (saliva), Oraquick HIV Self Test, and one that is blood based via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test and Atomo HIV Self Test - Both~Oraquick HIV Self Test and Atomo HIV Self Test - Both: This is an oral swab in home HIV test and this is a blood finger prick in home HIV test."
2173|NCT03271424|O1|Outcome|In Clinic Observation-Both (Oraquick Results)|"10 young women and 10 young men were assigned and conducted BOTH of the HIV self-tests. Participants tried two different self-testing kits, one that is oral fluid based (saliva), Oraquick HIV Self Test, and one that is blood based via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test and Atomo HIV Self Test - Both~Oraquick HIV Self Test and Atomo HIV Self Test - Both: This is an oral swab in home HIV test and this is a blood finger prick in home HIV test."
2174|NCT03271424|O1|Outcome|Focus Group Discussions|Focus group discussions (FGD) with young women (n=2 FGDs) and young men (n=2 FGDs) in the study area to determine the best way to offer self-testing to study participants.
2175|NCT03271424|E3|Reported Event|In Clinic Observation-Subject Choice|"20 young women and 20 young men were assigned and conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice~Oraquick HIV Self Test - Choice: This is an oral swab in home HIV test.~Atomo HIV Self Test - Choice: This is a blood finger prick in home HIV test."
2176|NCT03271424|E2|Reported Event|In Clinic Observation-Both|"10 young women and 10 young men were assigned and conducted BOTH of the HIV self-tests. Participants tried two different self-testing kits, one that is oral fluid based (saliva), Oraquick HIV Self Test, and one that is blood based via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test and Atomo HIV Self Test - Both~Oraquick HIV Self Test and Atomo HIV Self Test - Both: This is an oral swab in home HIV test and this is a blood finger prick in home HIV test."
2177|NCT03271424|E1|Reported Event|Focus Group Discussions|Focus group discussions (FGD) with young women (n=2 FGDs) and young men (n=2 FGDs) in the study area to determine the best way to offer self-testing to study participants.
2178|NCT03256552|B1|Baseline|All Subjects|All Subjects in the MITT Population
2179|NCT03256552|P1|Participant Flow|Overall Study|All Subjects Randomized
2180|NCT03256552|O4|Outcome|Placebo MDI|Placebo MDI
2181|NCT03256552|O3|Outcome|GP MDI 7.2 µg|Glycopyrronium 7.2 µg
2182|NCT03256552|O2|Outcome|GP MDI 14.4 µg|Glycopyrronium 14.4 µg
2183|NCT03256552|O1|Outcome|GP MDI 28.8 µg|Glycopyrronium MDI 28.8 µg
2184|NCT03256552|O4|Outcome|Placebo MDI|Placebo MDI
2185|NCT03256552|O3|Outcome|GP MDI 7.2 µg|Glycopyrronium 7.2 µg
2186|NCT03256552|O2|Outcome|GP MDI 14.4 µg|Glycopyrronium 14.4 µg
2187|NCT03256552|O1|Outcome|GP MDI 28.8 µg|Glycopyrronium MDI 28.8 µg
2188|NCT03256552|O4|Outcome|Placebo MDI|Placebo MDI
2189|NCT03256552|O3|Outcome|GP MDI 7.2 µg|Glycopyrronium 7.2 µg
2198|NCT03256552|E2|Reported Event|GP MDI 14.4 µg|Glycopyrronium 14.4 µg
2199|NCT03256552|E1|Reported Event|GP MDI 28.8 µg|Glycopyrronium MDI 28.8 µg
2200|NCT03255733|B1|Baseline|Intense Therapeutic Ultrasound Treatment|"Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart.~Intense Therapeutic Ultrasound Treatment"
2201|NCT03255733|P1|Participant Flow|Intense Therapeutic Ultrasound Treatment|"Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart.~Intense Therapeutic Ultrasound Treatment"
2202|NCT03255733|O1|Outcome|Intense Therapeutic Ultrasound Treatment|"Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart.~Intense Therapeutic Ultrasound Treatment"
2203|NCT03255733|O1|Outcome|Intense Therapeutic Ultrasound Treatment|"Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart.~Intense Therapeutic Ultrasound Treatment"
2204|NCT03255733|E1|Reported Event|Intense Therapeutic Ultrasound Treatment|"Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart.~Intense Therapeutic Ultrasound Treatment"
2205|NCT03255655|B3|Baseline|Total|Total of all reporting groups
2206|NCT03255655|B2|Baseline|Sham ITU Treatment for Chronic Plantar Fasciitis|"Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart.~Intense Therapeutic Ultrasound Treatment - ITU"
2207|NCT03255655|B1|Baseline|ITU Treatment for Chronic Plantar Fasciitis|"Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart.~Intense Therapeutic Ultrasound Treatment - ITU"
2208|NCT03255655|P2|Participant Flow|Sham ITU Treatment for Chronic Plantar Fasciitis|"Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart.~Intense Therapeutic Ultrasound Treatment - ITU"
2209|NCT03255655|P1|Participant Flow|ITU Treatment for Chronic Plantar Fasciitis|"Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart.~Intense Therapeutic Ultrasound Treatment - ITU"
2210|NCT03255655|O2|Outcome|Sham ITU Treatment for Chronic Plantar Fasciitis|"Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart.~Intense Therapeutic Ultrasound Treatment - ITU"
2211|NCT03255655|O1|Outcome|ITU Treatment for Chronic Plantar Fasciitis|"Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart.~Intense Therapeutic Ultrasound Treatment - ITU"
2212|NCT03255655|O2|Outcome|Sham ITU Treatment for Chronic Plantar Fasciitis|"Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart.~Intense Therapeutic Ultrasound Treatment - ITU"
2213|NCT03255655|O1|Outcome|ITU Treatment for Chronic Plantar Fasciitis|"Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart.~Intense Therapeutic Ultrasound Treatment - ITU"
2214|NCT03255655|E2|Reported Event|Sham ITU Treatment for Chronic Plantar Fasciitis|"Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart.~Intense Therapeutic Ultrasound Treatment - ITU"
2215|NCT03255655|E1|Reported Event|ITU Treatment for Chronic Plantar Fasciitis|"Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart.~Intense Therapeutic Ultrasound Treatment - ITU"
2216|NCT03254602|B1|Baseline|Intense Therapeutic Ultrasound Treatment|"Intense Therapeutic Ultrasound treatment applied along the length and width of the proximal Plantar Fascia. 1000 - 5 Joule pulses were applied twice, four weeks apart.~Intense Therapeutic Ultrasound Treatment"
2217|NCT03254602|P1|Participant Flow|Intense Therapeutic Ultrasound Treatment|"Intense Therapeutic Ultrasound treatment applied along the length and width of the proximal Plantar Fascia. 1000 - 5 Joule pulses were applied twice, four weeks apart.~Intense Therapeutic Ultrasound Treatment"
2218|NCT03254602|O1|Outcome|Intense Therapeutic Ultrasound Treatment|"Intense Therapeutic Ultrasound treatment applied along the length and width of the proximal Plantar Fascia. 1000 - 5 Joule pulses were applied twice, four weeks apart.~Intense Therapeutic Ultrasound Treatment"
2219|NCT03254602|O1|Outcome|Intense Therapeutic Ultrasound Treatment|"Intense Therapeutic Ultrasound treatment applied along the length and width of the proximal Plantar Fascia. 1000 - 5 Joule pulses were applied twice, four weeks apart.~Intense Therapeutic Ultrasound Treatment"
2220|NCT03254602|O1|Outcome|Intense Therapeutic Ultrasound Treatment|"Intense Therapeutic Ultrasound treatment applied along the length and width of the proximal Plantar Fascia. 1000 - 5 Joule pulses were applied twice, four weeks apart.~Intense Therapeutic Ultrasound Treatment"
2221|NCT03254602|E1|Reported Event|Intense Therapeutic Ultrasound Treatment|"Intense Therapeutic Ultrasound treatment applied along the length and width of the proximal Plantar Fascia. 1000 - 5 Joule pulses were applied twice, four weeks apart.~Intense Therapeutic Ultrasound Treatment"
2222|NCT03247985|B3|Baseline|Total|Total of all reporting groups
2223|NCT03247985|B2|Baseline|ProGrip Self-fixating Mesh|"Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery~ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open & laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of “Velcro” to the soft tissue surfaces resulting in self-fixation"
2224|NCT03247985|B1|Baseline|PROLENE Polypropylene Tacking Mesh|"Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.~PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks"
2252|NCT03238001|B1|Baseline|All Participants|All participants enrolled in the study.
2225|NCT03247985|P2|Participant Flow|ProGrip Self-fixating Mesh|"Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery~ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open & laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of “Velcro” to the soft tissue surfaces resulting in self-fixation"
2226|NCT03247985|P1|Participant Flow|PROLENE Polypropylene Tacking Mesh|"Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.~PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks"
2227|NCT03247985|O2|Outcome|ProGrip Self-fixating Mesh|"Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery~ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open & laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of “Velcro” to the soft tissue surfaces resulting in self-fixation"
2228|NCT03247985|O1|Outcome|PROLENE Polypropylene Tacking Mesh|"Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.~PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks"
2229|NCT03247985|O2|Outcome|ProGrip Self-fixating Mesh|"Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery~ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open & laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of “Velcro” to the soft tissue surfaces resulting in self-fixation"
2230|NCT03247985|O1|Outcome|PROLENE Polypropylene Tacking Mesh|"Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.~PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks"
2231|NCT03247985|O2|Outcome|ProGrip Self-fixating Mesh|"Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery~ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open & laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of “Velcro” to the soft tissue surfaces resulting in self-fixation"
2232|NCT03247985|O1|Outcome|PROLENE Polypropylene Tacking Mesh|"Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.~PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks"
2233|NCT03247985|O2|Outcome|ProGrip Self-fixating Mesh|"Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery~ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open & laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of “Velcro” to the soft tissue surfaces resulting in self-fixation"
2234|NCT03247985|O1|Outcome|PROLENE Polypropylene Tacking Mesh|"Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.~PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks"
2235|NCT03247985|O2|Outcome|ProGrip Self-fixating Mesh|"Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery~ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open & laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of “Velcro” to the soft tissue surfaces resulting in self-fixation"
2236|NCT03247985|O1|Outcome|PROLENE Polypropylene Tacking Mesh|"Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.~PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks"
2237|NCT03247985|E2|Reported Event|ProGrip Self-fixating Mesh|"Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery~ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open & laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of “Velcro” to the soft tissue surfaces resulting in self-fixation"
2238|NCT03247985|E1|Reported Event|PROLENE Polypropylene Tacking Mesh|"Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.~PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks"
2239|NCT03238924|B3|Baseline|Total|Total of all reporting groups
2240|NCT03238924|B2|Baseline|Placebo|"Placebo is matching saline nasal spray~Placebos: Saline nasal spray, self-administered"
2241|NCT03238924|B1|Baseline|Oxytocin|"40 IU intranasal oxytocin spray~Oxytocin: 40 IU oxytocin nasal spray, self-administered"
2242|NCT03238924|P2|Participant Flow|Placebo|"Placebo is matching saline nasal spray~Placebos: Saline nasal spray, self-administered"
2243|NCT03238924|P1|Participant Flow|Oxytocin|"40 IU intranasal oxytocin spray~Oxytocin: 40 IU oxytocin nasal spray, self-administered"
2244|NCT03238924|O2|Outcome|Placebo|"Placebo is matching saline nasal spray~Placebos: Saline nasal spray, self-administered"
2245|NCT03238924|O1|Outcome|Oxytocin|"40 IU intranasal oxytocin spray~Oxytocin: 40 IU oxytocin nasal spray, self-administered"
2246|NCT03238924|O2|Outcome|Placebo|"Placebo is matching saline nasal spray~Placebos: Saline nasal spray, self-administered"
2247|NCT03238924|O1|Outcome|Oxytocin|"40 IU intranasal oxytocin spray~Oxytocin: 40 IU oxytocin nasal spray, self-administered"
2248|NCT03238924|O2|Outcome|Placebo|"Placebo is matching saline nasal spray~Placebos: Saline nasal spray, self-administered"
2249|NCT03238924|O1|Outcome|Oxytocin|"40 IU intranasal oxytocin spray~Oxytocin: 40 IU oxytocin nasal spray, self-administered"
2250|NCT03238924|E2|Reported Event|Placebo|"Placebo is matching saline nasal spray~Placebos: Saline nasal spray, self-administered"
2251|NCT03238924|E1|Reported Event|Oxytocin|"40 IU intranasal oxytocin spray~Oxytocin: 40 IU oxytocin nasal spray, self-administered"
2253|NCT03238001|P1|Participant Flow|All Qualified Participants|Participants received the DCTclock test and a battery of other traditional, pen and paper, neuropsychological assessments.
2254|NCT03238001|O1|Outcome|All Participants|Participants received DCTclock, MMSE, MoCA, and a battery of other traditional pen and paper neuropsychological assessments.
2255|NCT03238001|O2|Outcome|MMSE|Participants received DCTclock, MMSE, MoCA, and a battery of other traditional pen and paper neuropsychological assessments.
2256|NCT03238001|O1|Outcome|DCTclock|Participants received DCTclock, MMSE, MoCA, and a battery of other traditional pen and paper neuropsychological assessments.
2257|NCT03238001|O2|Outcome|MMSE|Participants received MMSE on their first and second visits, occurring 1-4 weeks apart.
2258|NCT03238001|O1|Outcome|DCTclock|Participants received DCTclock on their first and second visits, occurring 1-4 weeks apart.
2259|NCT03238001|O2|Outcome|MMSE|Participants received MMSE on their first and second visits, occurring 1-4 weeks apart.
2260|NCT03238001|O1|Outcome|DCTclock|Participants received DCTclock on their first and second visits, occurring 1-4 weeks apart.
2261|NCT03238001|O2|Outcome|MMSE|Participants received MMSE on their first and second visits, occurring 1-4 weeks apart.
2262|NCT03238001|O1|Outcome|DCTclock|Participants received DCTclock on their first and second visits, occurring 1-4 weeks apart.
2263|NCT03238001|O2|Outcome|MMSE|Participants received MMSE on their first and second visits, occurring 1-4 weeks apart.
2264|NCT03238001|O1|Outcome|DCTclock|Participants received DCTclock on their first and second visits, occurring 1-4 weeks apart.
2265|NCT03238001|O2|Outcome|MMSE|Participants received MMSE and MoCA on their first visit.
2266|NCT03238001|O1|Outcome|DCTclock|Participants received DCTclock and MoCA on their first visit
2267|NCT03238001|O2|Outcome|MMSE|Participants received MMSE and MoCA on their first visit.
2268|NCT03238001|O1|Outcome|DCTclock|Participants received DCTclock and MoCA on their first visit.
2269|NCT03238001|O2|Outcome|MMSE|Participants received MMSE and MoCA on their first visit.
2270|NCT03238001|O1|Outcome|DCTclock|Participants received DCTclock and MoCA on their first visit.
2271|NCT03238001|O2|Outcome|MMSE|Participants received MMSE and MoCA on their first visit.
2272|NCT03238001|O1|Outcome|DCTclock|Participants received DCTclock and MoCA on their first visit.
2273|NCT03238001|O1|Outcome|Primary Endpoint (Evaluable) Population|Participants received DCTclock, MMSE, MoCA, and a battery of other traditional pen and paper neuropsychological assessments.
2274|NCT03238001|E1|Reported Event|All Participants|Participants received DCTclock, MMSE, MoCA, and a battery of other traditional, pen and paper neuropsychological assessments.
2275|NCT03235817|B4|Baseline|Total|Total of all reporting groups
2276|NCT03235817|B3|Baseline|Pressure Control Ventilation|Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.
2277|NCT03235817|B2|Baseline|Pressure Support Ventilation|Pressure support ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
2278|NCT03235817|B1|Baseline|Spontaneous Ventilation|Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.
2279|NCT03235817|P3|Participant Flow|Pressure Control Ventilation|Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.
2280|NCT03235817|P2|Participant Flow|Pressure Support Ventilation|Pressure support ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
2281|NCT03235817|P1|Participant Flow|Spontaneous Ventilation|Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.
2282|NCT03235817|O2|Outcome|Pressure Control Ventilation|Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.
2283|NCT03235817|O1|Outcome|Pressure Support Ventilation|Pressure support ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
2284|NCT03235817|O2|Outcome|Pressure Control Ventilation|Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.
2285|NCT03235817|O1|Outcome|Spontaneous Ventilation|Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.
2286|NCT03235817|O2|Outcome|Pressure Support Ventilation|Pressure support ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
2287|NCT03235817|O1|Outcome|Spontaneous Ventilation|Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.
2288|NCT03235817|O2|Outcome|Pressure Control Ventilation|Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.
2289|NCT03235817|O1|Outcome|Pressure Support Ventilation|Pressure support ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
2290|NCT03235817|O2|Outcome|Pressure Control Ventilation|Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.
2291|NCT03235817|O1|Outcome|Spontaneous Ventilation|Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.
2292|NCT03235817|O2|Outcome|Pressure Support Ventilation|Pressure support ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
2293|NCT03235817|O1|Outcome|Spontaneous Ventilation|Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.
2294|NCT03235817|E3|Reported Event|Pressure Control Ventilation|Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.
2295|NCT03235817|E2|Reported Event|Pressure Support Ventilation|Pressure support ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
2296|NCT03235817|E1|Reported Event|Spontaneous Ventilation|Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.
2297|NCT03231371|B1|Baseline|Study Arm|Adenosine: Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose).
2298|NCT03231371|P1|Participant Flow|Study Arm|Adenosine: Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose).
2299|NCT03231371|O1|Outcome|Study Arm|Adenosine: Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose).
2300|NCT03231371|O1|Outcome|Study Arm|Adenosine: Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose).
2301|NCT03231371|E1|Reported Event|Study Arm|Adenosine: Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose).
2302|NCT03225001|B1|Baseline|Edwards SAPIEN XT THV in Patients With Failing SAVR|"Patients with a failing surgical bioprosthetic valve (SAVR) in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve.~Edwards SAPIEN XT transcatheter valve, Model 9300TFX: Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems."
2303|NCT03225001|P1|Participant Flow|Edwards SAPIEN XT THV in Patients With Failing SAVR|"Patients with a failing surgical bioprosthetic valve (SAVR) in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve.~Edwards SAPIEN XT transcatheter valve, Model 9300TFX: Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems."
2304|NCT03225001|O1|Outcome|Edwards SAPIEN XT THV in Patients With Failing SAVR|"Patients with a failing surgical bioprosthetic valve (SAVR) in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve.~Edwards SAPIEN XT transcatheter valve, Model 9300TFX: Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems."
2305|NCT03225001|O1|Outcome|Edwards SAPIEN XT THV in Patients With Failing SAVR|"Patients with a failing surgical bioprosthetic valve (SAVR) in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve.~Edwards SAPIEN XT transcatheter valve, Model 9300TFX: Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems."
2306|NCT03225001|E1|Reported Event|Edwards SAPIEN XT THV in Patients With Failing SAVR|"Patients with a failing surgical bioprosthetic valve (SAVR) in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve.~Edwards SAPIEN XT transcatheter valve, Model 9300TFX: Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems."
2307|NCT03218163|B1|Baseline|MEDI-551 Treatment Arm|"Medi-551 maintenance therapy will be initiated on Day 60, Day 90, or Day 120 of NM-AlloSCT based on the eligibility criteria for the initiation of maintenance therapy as described in Section 3.1. MEDI-551 will be administered on 28-day cycles at a dose of 4mg/kg, as an IV infusion over 60 ±15 minutes. Infusion sets must contain a 0.2 micron in-line filter. MEDI-551 will be administered on days 1, 8, 15, and 22 of cycle 1, then 4mg/kg IV on day1 of cycles 2 through 12. Treatment may be stopped earlier if there is unacceptable toxicity, development of Grade 3 or 4 GVHD, documentation of disease progression, or patient withdrawal for other reasons.~MEDI-551 Maintenance: Cycle 1 - Days 1, 8, 15, and 22: 4mg/kg IV Cycles 2-12 - Day 1: 4mg/kg IV"
2308|NCT03218163|P1|Participant Flow|MEDI-551 Treatment Arm|"MEDI-551 maintenance therapy will be initiated on Day 60, Day 90, or Day 120 of NM-AlloSCT based on the eligibility criteria for the initiation of maintenance therapy as described in Section 3.1. MEDI-551 will be administered on 28-day cycles at a dose of 4mg/kg, as an IV infusion over 60 ±15 minutes. Infusion sets must contain a 0.2 micron in-line filter. MEDI-551 will be administered on days 1, 8, 15, and 22 of cycle 1, then 4mg/kg IV on day1 of cycles 2 through 12. Treatment may be stopped earlier if there is unacceptable toxicity, development of Grade 3 or 4 graft-versus-host disease (GVHD), documentation of disease progression, or patient withdrawal for other reasons.~MEDI-551 Maintenance: Cycle 1 - Days 1, 8, 15, and 22: 4mg/kg IV Cycles 2-12 - Day 1: 4mg/kg IV"
2309|NCT03218163|O1|Outcome|MEDI-551 Treatment Arm|"Medi-551 maintenance therapy will be initiated on Day 60, Day 90, or Day 120 of NM-AlloSCT based on the eligibility criteria for the initiation of maintenance therapy as described in Section 3.1. MEDI-551 will be administered on 28-day cycles at a dose of 4mg/kg, as an IV infusion over 60 ±15 minutes. Infusion sets must contain a 0.2 micron in-line filter. MEDI-551 will be administered on days 1, 8, 15, and 22 of cycle 1, then 4mg/kg IV on day1 of cycles 2 through 12. Treatment may be stopped earlier if there is unacceptable toxicity, development of Grade 3 or 4 GVHD, documentation of disease progression, or patient withdrawal for other reasons.~MEDI-551 Maintenance: Cycle 1 - Days 1, 8, 15, and 22: 4mg/kg IV Cycles 2-12 - Day 1: 4mg/kg IV"
2310|NCT03218163|E1|Reported Event|MEDI-551 Treatment Arm|"Medi-551 maintenance therapy will be initiated on Day 60, Day 90, or Day 120 of NM-AlloSCT based on the eligibility criteria for the initiation of maintenance therapy as described in Section 3.1. MEDI-551 will be administered on 28-day cycles at a dose of 4mg/kg, as an IV infusion over 60 ±15 minutes. Infusion sets must contain a 0.2 micron in-line filter. MEDI-551 will be administered on days 1, 8, 15, and 22 of cycle 1, then 4mg/kg IV on day1 of cycles 2 through 12. Treatment may be stopped earlier if there is unacceptable toxicity, development of Grade 3 or 4 GVHD, documentation of disease progression, or patient withdrawal for other reasons.~MEDI-551 Maintenance: Cycle 1 - Days 1, 8, 15, and 22: 4mg/kg IV Cycles 2-12 - Day 1: 4mg/kg IV"
2311|NCT03191552|B4|Baseline|Total|Total of all reporting groups
2312|NCT03191552|B3|Baseline|Control (Conventional Exercises)|Control group (received only conventional exercise therapy) 8 were recruited/ 8 completed the study
2352|NCT03191552|O1|Outcome|SPIO 2 Hours|SPIO 2 hours (worn SPIO 2 hours during therapy)
2851|NCT03048006|O1|Outcome|All Included Patients|All included patients underwent MRI with Dotarem
2313|NCT03191552|B2|Baseline|SPIO 6 Hours|"SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy).~9 were allocated, one of them withdrew due to surgery for progressive hip dysplasia between the assessments at 1 month and 3 months and 8 completed."
2314|NCT03191552|B1|Baseline|SPIO 2 Hours|"SPIO 2 hours (worn SPIO 2 hours during therapy)~9 were allocated, one of them lost follow up before the assessment at 1 month and 8 completed"
2315|NCT03191552|P3|Participant Flow|Control (Conventional Exercises)|"Control group will only receive conventional exercise therapy (for two hours a day) including range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills during hospital inpatient stay throughout 2 weeks~conventional exercises: range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills"
2316|NCT03191552|P2|Participant Flow|SPIO (Stabilizing Pressure Input Orthosis) 6 Hours|"SPIO 6 hours group will receive conventional exercise therapy with the garment on for 2 hours and worn SPIO 4 hours more in addition to 2 hour of wear during exercise therapy.~SPIO (stabilizing input pressure orthosis): SPIO 2 hours will receive conventional exercise therapy with the garment on during 2 hours. SPIO 6 hours group wore the SPIO 4 hours more in addition to 2 hours during therapy.~SPIO 6 hours group will wear the SPIO 4 hours more in addition to 2 hours during therapy.~(conventional exercises :range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills~conventional exercises: range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills"
2317|NCT03191552|P1|Participant Flow|SPIO(Stabilizing Pressure Input Orthosis) 2 Hours|"All children will be hospitalized for 2 weeks and will receive conventional exercise therapy including range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills during hospital inpatient stay throughout 2 weeks 2 hours a day.~SPIO 2 hours group will receive conventional exercise therapy with the garment on for 2 hours.~SPIO (stabilizing input pressure orthosis): SPIO 2 hours will receive conventional exercise therapy with the garment on during 2 hours. SPIO 6 hours group wore the SPIO 4 hours more in addition to 2 hours during therapy.~SPIO 6 hours group will wear the SPIO 4 hours more in addition to 2 hours during therapy.~(conventional exercises :range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills~conventional exercises: range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross"
2318|NCT03191552|O2|Outcome|SPIO 6 Hours|SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
2319|NCT03191552|O1|Outcome|SPIO 2 Hours|SPIO 2 hours (worn SPIO 2 hours during therapy)
2320|NCT03191552|O2|Outcome|SPIO 6 Hours|SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
2321|NCT03191552|O1|Outcome|SPIO 2 Hours|SPIO 2 hours (worn SPIO 2 hours during therapy)
2322|NCT03191552|O2|Outcome|SPIO 6 Hours|SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
2323|NCT03191552|O1|Outcome|SPIO 2 Hours|SPIO 2 hours (worn SPIO 2 hours during therapy)
2324|NCT03191552|O3|Outcome|Control (Conventional Exercises)|Control group (received only conventional exercise therapy),
2325|NCT03191552|O2|Outcome|SPIO 6 Hours|SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
2326|NCT03191552|O1|Outcome|SPIO 2 Hours|SPIO 2 hours (worn SPIO 2 hours during therapy)
2327|NCT03191552|O3|Outcome|Control (Conventional Exercises)|Control group (received only conventional exercise therapy),
2328|NCT03191552|O2|Outcome|SPIO 6 Hours|SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
2329|NCT03191552|O1|Outcome|SPIO 2 Hours|SPIO 2 hours (worn SPIO 2 hours during therapy)
2330|NCT03191552|O3|Outcome|Control (Conventional Exercises)|Control group (received only conventional exercise therapy),
2331|NCT03191552|O2|Outcome|SPIO 6 Hours|SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
2332|NCT03191552|O1|Outcome|SPIO 2 Hours|SPIO 2 hours (worn SPIO 2 hours during therapy)
2333|NCT03191552|O3|Outcome|Control (Conventional Exercises)|Control group (received only conventional exercise therapy),
2334|NCT03191552|O2|Outcome|SPIO 6 Hours|SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
2335|NCT03191552|O1|Outcome|SPIO 2 Hours|SPIO 2 hours (worn SPIO 2 hours during therapy)
2336|NCT03191552|O3|Outcome|Control (Conventional Exercises)|Control group (received only conventional exercise therapy),
2337|NCT03191552|O2|Outcome|SPIO 6 Hours|SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
2338|NCT03191552|O1|Outcome|SPIO 2 Hours|SPIO 2 hours (worn SPIO 2 hours during therapy)
2339|NCT03191552|O3|Outcome|Control (Conventional Exercises)|Control group (received only conventional exercise therapy),
2340|NCT03191552|O2|Outcome|SPIO 6 Hours|SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
2341|NCT03191552|O1|Outcome|SPIO 2 Hours|SPIO 2 hours (worn SPIO 2 hours during therapy)
2342|NCT03191552|O2|Outcome|İmmediate After Orthosis Wear|Box and Block Test Score of SPIO groups immediate after the orthosis wear (orthosis is tailor made and only children in SPIO groups had the orthosis so the arm control (conventinal exercises) group is not included)
2343|NCT03191552|O1|Outcome|Before Treatment|Box and Block Test Score of SPIO groups before Treatment (orthosis is tailor made and only children in SPIO groups had the orthosis so the arm control (conventinal exercises) group is not included)
2344|NCT03191552|O3|Outcome|Control (Conventional Exercises)|Control group (received only conventional exercise therapy),
2345|NCT03191552|O2|Outcome|SPIO 6 Hours|SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
2346|NCT03191552|O1|Outcome|SPIO 2 Hours|SPIO 2 hours (worn SPIO 2 hours during therapy)
2347|NCT03191552|O3|Outcome|Control (Conventional Exercises)|Control group (received only conventional exercise therapy),
2348|NCT03191552|O2|Outcome|SPIO 6 Hours|SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
2349|NCT03191552|O1|Outcome|SPIO 2 Hours|SPIO 2 hours (worn SPIO 2 hours during therapy)
2350|NCT03191552|O3|Outcome|Control (Conventional Exercises)|Control group (received only conventional exercise therapy),
2351|NCT03191552|O2|Outcome|SPIO 6 Hours|SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
2353|NCT03191552|O3|Outcome|Control (Conventional Exercises)|Control group (received only conventional exercise therapy),
2354|NCT03191552|O2|Outcome|SPIO 6 Hours|SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
2355|NCT03191552|O1|Outcome|SPIO 2 Hours|SPIO 2 hours (worn SPIO 2 hours during therapy)
2356|NCT03191552|O3|Outcome|Control (Conventional Exercises)|Control group (received only conventional exercise therapy),
2357|NCT03191552|O2|Outcome|SPIO 6 Hours|SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
2358|NCT03191552|O1|Outcome|SPIO 2 Hours|SPIO 2 hours (worn SPIO 2 hours during therapy)
2359|NCT03191552|O3|Outcome|Control (Conventional Exercises)|Control group (received only conventional exercise therapy),
2360|NCT03191552|O2|Outcome|SPIO 6 Hours|SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
2361|NCT03191552|O1|Outcome|SPIO 2 Hours|SPIO 2 hours (worn SPIO 2 hours during therapy)
2362|NCT03191552|O2|Outcome|Immediately After Orthosis Worn|Immediate evaluation after orthosis worn
2363|NCT03191552|O1|Outcome|Before Treatment|SPIO groups before treatment (orthosis is tailor made and only children in SPIO groups had the orthosis so the arm control (conventinal exercises) group is not included)
2364|NCT03191552|E3|Reported Event|Control (Conventional Exercises)|Control group (received only conventional exercise therapy),
2365|NCT03191552|E2|Reported Event|SPIO 6 Hours|SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
2366|NCT03191552|E1|Reported Event|SPIO 2 Hours|SPIO 2 hours (worn SPIO 2 hours during therapy)
2367|NCT03182582|B1|Baseline|All Participants|"Laser debridement will be performed at 200-um until punctate bleeding is visualized. Ssharp debridement will be performed via a scalpel/curette until punctate bleeding is visualized.~Tissue biopsies will then be obtained from the wounds prior to the first treatment, immediately after the first treatment, immediately prior to the subsequent treatment, and immediately after the second treatment. These will then be sent to Pathogenius for molecular analysis of wound microflora using polymerase chain reaction and sequencing.~Pain will be assessed during debridement by recording the Numerical Rating Scale for pain assessment."
2368|NCT03182582|P2|Participant Flow|Sharp, Then Laser|"During the first treatment, sharp debridement will be performed via a scalpel/curette until punctate bleeding is visualized. During the second treatment, laser debridement will be performed at 200-um until punctate bleeding is visualized.~Tissue biopsies will then be obtained from the wounds prior to the first treatment, immediately after the first treatment, immediately prior to the subsequent treatment, and immediately after the second treatment. These will then be sent to Pathogenius for molecular analysis of wound microflora using polymerase chain reaction and sequencing.~Pain will be assessed during debridement by recording the Numerical Rating Scale for pain assessment."
2369|NCT03182582|P1|Participant Flow|Laser, Then Sharp|"During the first treatment, laser debridement will be performed at 200-um until punctate bleeding is visualized. During the second treatment, sharp debridement will be performed via a scalpel/curette until punctate bleeding is visualized.~Tissue biopsies will then be obtained from the wounds prior to the first treatment, immediately after the first treatment, immediately prior to the subsequent treatment, and immediately after the second treatment. These will then be sent to Pathogenius for molecular analysis of wound microflora using polymerase chain reaction and sequencing.~Pain will be assessed during debridement by recording the Numerical Rating Scale for pain assessment."
2370|NCT03182582|O2|Outcome|Sharp Debridement|Sharp debridement was performed via a scalpel/curette until punctate bleeding is visualized. Pain was assessed during debridement by recording the Numerical Rating Scale for pain assessment.
2371|NCT03182582|O1|Outcome|Laser Debridement|Laser debridement was performed at 200-um until punctate bleeding is visualized. Pain was assessed during debridement by recording the Numerical Rating Scale for pain assessment.
2372|NCT03182582|O2|Outcome|Sharp Debridement|Sharp debridement was performed via a scalpel/curette until punctate bleeding is visualized. Pain was assessed during debridement by recording the Numerical Rating Scale for pain assessment.
2373|NCT03182582|O1|Outcome|Laser Debridement|Laser debridement was performed at 200-um until punctate bleeding is visualized. Pain was assessed during debridement by recording the Numerical Rating Scale for pain assessment.
2374|NCT03182582|O1|Outcome|All Participants|"Laser debridement will be performed at 200-um until punctate bleeding is visualized. Ssharp debridement will be performed via a scalpel/curette until punctate bleeding is visualized.~Tissue biopsies will then be obtained from the wounds prior to the first treatment, immediately after the first treatment, immediately prior to the subsequent treatment, and immediately after the second treatment. These will then be sent to Pathogenius for molecular analysis of wound microflora using polymerase chain reaction and sequencing.~Pain will be assessed during debridement by recording the Numerical Rating Scale for pain assessment."
2375|NCT03182582|O2|Outcome|Post-Sharp Debridement|A tissue biopsy was performed after curette/scalpel debridement. This tissue was analyzed for bacterial load.
2376|NCT03182582|O1|Outcome|Pre-Sharp Debridement|A tissue biopsy was performed prior to curette/scalpel debridement. This tissue was analyzed for bacterial load.
2377|NCT03182582|O2|Outcome|Post-Laser Debridement|A tissue biopsy was performed after laser debridement. This tissue was analyzed for bacterial load.
2378|NCT03182582|O1|Outcome|Pre-Laser Debridement|A tissue biopsy was performed prior to laser debridement. This tissue was analyzed for bacterial load.
2379|NCT03182582|O2|Outcome|Sharp Debridement|Sharp debridement was performed via a scalpel/curette until punctate bleeding is visualized. Pain was assessed during debridement by recording the Numerical Rating Scale for pain assessment.
2380|NCT03182582|O1|Outcome|Laser Debridement|Laser debridement was performed at 200-um until punctate bleeding is visualized. Pain was assessed during debridement by recording the Numerical Rating Scale for pain assessment.
2381|NCT03182582|E2|Reported Event|Sharp Debridement|Sharp debridement was performed via a scalpel/curette until punctate bleeding is visualized. Pain was assessed during debridement by recording the Numerical Rating Scale for pain assessment.
2382|NCT03182582|E1|Reported Event|Laser Debridement|Laser debridement was performed at 200-um until punctate bleeding is visualized. Pain was assessed during debridement by recording the Numerical Rating Scale for pain assessment.
2383|NCT03163134|B3|Baseline|Total|Total of all reporting groups
2852|NCT03048006|O1|Outcome|All Included Patients|All included patients underwent MRI with Dotarem
2384|NCT03163134|B2|Baseline|Lumbar Drain Group|"Group of patients that received a lumbar drain after surgery.~Lumbar Drain"
2385|NCT03163134|B1|Baseline|No Lumbar Drain Group|Group of patients that did not receive a lumbar drain after surgery.
2386|NCT03163134|P2|Participant Flow|Lumbar Drain Group|"Group of patients that received a lumbar drain after surgery~Lumbar Drain"
2387|NCT03163134|P1|Participant Flow|No Lumbar Drain Group|Group of patients that did not receive a lumbar drain after surgery
2388|NCT03163134|O2|Outcome|Lumbar Drain Group|"Group of patients that received a lumbar drain after surgery.~Lumbar Drain"
2389|NCT03163134|O1|Outcome|No Lumbar Drain Group|Group of patients that did not receive a lumbar drain after surgery.
2390|NCT03163134|O2|Outcome|Lumbar Drain Group|"Group of patients that received a lumbar drain after surgery.~Lumbar Drain"
2391|NCT03163134|O1|Outcome|No Lumbar Drain Group|Group of patients that did not receive a lumbar drain after surgery.
2392|NCT03163134|E2|Reported Event|Lumbar Drain Group|"Group of patients that received a lumbar drain after surgery~Lumbar Drain"
2393|NCT03163134|E1|Reported Event|No Lumbar Drain Group|Group of patients that did not receive a lumbar drain after surgery
2394|NCT03159143|B1|Baseline|Docetaxel and Oxaliplatin|"Docetaxel administered at a dose of 60mg/m^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m^2 as a 2 hour IV infusion.~Docetaxel: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m^2.~Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2"
2395|NCT03159143|P1|Participant Flow|Docetaxel and Oxaliplatin|"Docetaxel administered at a dose of 60mg/m^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m^2 as a 2 hour IV infusion.~Docetaxel: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m^2.~Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2"
2396|NCT03159143|O1|Outcome|Docetaxel and Oxaliplatin|"Docetaxel administered at a dose of 60mg/m^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m^2 as a 2 hour IV infusion.~Docetaxel: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m^2.~Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2"
2397|NCT03159143|O1|Outcome|Docetaxel and Oxaliplatin|"Docetaxel administered at a dose of 60mg/m^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m^2 as a 2 hour IV infusion.~Docetaxel: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m^2.~Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2"
2398|NCT03159143|O1|Outcome|Docetaxel and Oxaliplatin|"Docetaxel administered at a dose of 60mg/m^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m^2 as a 2 hour IV infusion.~Docetaxel: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m^2.~Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2"
2399|NCT03159143|O1|Outcome|Docetaxel and Oxaliplatin|"Docetaxel administered at a dose of 60mg/m^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m^2 as a 2 hour IV infusion.~Docetaxel: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m^2.~Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2"
2400|NCT03159143|E1|Reported Event|Docetaxel and Oxaliplatin|"Docetaxel administered at a dose of 60mg/m^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m^2 as a 2 hour IV infusion.~Docetaxel: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m^2.~Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2"
2401|NCT03157232|B1|Baseline|Test Group|All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor.
2402|NCT03157232|P1|Participant Flow|Test Group|All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor.
2403|NCT03157232|O1|Outcome|Test Group|All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor.
2404|NCT03157232|E1|Reported Event|Test Group|All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor.
2405|NCT03151226|B1|Baseline|Capnography Monitoring|"single arm, all subjects receiving duramorph will receive capnography monitoring~Capnography monitoring: capnography and pulse oximetry will be initiated in the recovery room and worn for 12-24 hours post delivery"
2406|NCT03151226|P1|Participant Flow|Capnography Monitoring|"single arm, all subjects receiving duramorph will receive capnography monitoring~Capnography monitoring: capnography and pulse oximetry will be initiated in the recovery room and worn for 12-24 hours post delivery"
2407|NCT03151226|O1|Outcome|Capnography Monitoring|"single arm, all subjects receiving duramorph will receive capnography monitoring~Capnography monitoring: capnography and pulse oximetry will be initiated in the recovery room and worn for 12-24 hours post delivery"
2408|NCT03151226|E1|Reported Event|Capnography Monitoring|"single arm, all subjects receiving duramorph will receive capnography monitoring~Capnography monitoring: capnography and pulse oximetry will be initiated in the recovery room and worn for 12-24 hours post delivery"
2853|NCT03048006|O1|Outcome|All Included Patients|All included patients underwent MRI with Dotarem
2409|NCT03134326|B1|Baseline|Test Group|All subjects will be enrolled in the test group and will receive both R1-25 and R2-25 Pulse Oximeter Sensors
2410|NCT03134326|P1|Participant Flow|Test Group|All subjects will be enrolled in the test group and will receive both R1-25 and R2-25 Pulse Oximeter Sensors
2411|NCT03134326|O1|Outcome|Test Group|All subjects will be enrolled in the test group and will receive both R1-25 and R2-25 Pulse Oximeter Sensors
2412|NCT03134326|E1|Reported Event|Test Group|All subjects will be enrolled in the test group and will receive both R1-25 and R2-25 Pulse Oximeter Sensors
2413|NCT03134313|B1|Baseline|R1-25 Sensor|"All subjects will be enrolled in the test group and will receive Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor~Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor"
2414|NCT03134313|P1|Participant Flow|R1-25 Sensor|"All subjects will be enrolled in the test group and will receive Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor~Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor"
2415|NCT03134313|O1|Outcome|R1-25 Sensor|All subjects will be enrolled in the test group and will receive Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor
2416|NCT03134313|E1|Reported Event|R1-25 Sensor|All subjects will be enrolled in the test group and will receive Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor
2417|NCT03128307|B1|Baseline|Clinical Trial Participants|Subjects who received the Zyppah Anti-Snoring device and were entered into the clinical study. Subjects were asked to use the device for ten consecutive nights and then fill out an online form assessing their experience with the device.
2418|NCT03128307|P1|Participant Flow|Clinical Trial Participants|Subjects who received the Zyppah Anti-Snoring device and were entered into the clinical study. Subjects were asked to use the device for ten consecutive nights and then fill out an online form assessing their experience with the device.
2419|NCT03128307|O1|Outcome|Clinical Trial Participants|Subjects who received the Zyppah Anti-Snoring device and were entered into the clinical study. Subjects were asked to use the device for ten consecutive nights and then fill out an online form assessing their experience with the device.
2420|NCT03128307|O1|Outcome|Clinical Trial Participants|Subjects who received the Zyppah Anti-Snoring device and were entered into the clinical study. Subjects were asked to use the device for ten consecutive nights and then fill out an online form assessing their experience with the device.
2421|NCT03128307|E1|Reported Event|Clinical Trial Participants|Subjects who received the Zyppah Anti-Snoring device and were entered into the clinical study. Subjects were asked to use the device for ten consecutive nights and then fill out an online form assessing their experience with the device.
2422|NCT03125031|B1|Baseline|Rainbow Adhesive Adult/Pediatric and Adult/Neonatal Sensors|All subjects are enrolled into the test group and receive the Rainbow adhesive sensors (adult/pediatric and adult/neonatal sensors).
2423|NCT03125031|P2|Participant Flow|Rainbow Adhesive Adult/Neonatal Sensor|All subjects are enrolled into the test group and receive the Rainbow adhesive adult/neonatal sensors.
2424|NCT03125031|P1|Participant Flow|Rainbow Adhesive Adult/Pediatric Sensor|All subjects are enrolled into the test group and receive the Rainbow adhesive adult/pediatric sensors.
2425|NCT03125031|O2|Outcome|Group-Sensor 2|All subjects are enrolled into the test group and receive the Rainbow adhesive adult/neonatal sensors.
2426|NCT03125031|O1|Outcome|Group-Sensor 1|All subjects are enrolled into the test group and receive the Rainbow adhesive adult/pediatric sensors.
2427|NCT03125031|E1|Reported Event|Rainbow Adhesive Adult/Pediatric and Adult/Neonatal Sensors|All subjects are enrolled into the test group and receive the Rainbow adhesive sensors (adult/pediatric and adult/neonatal).
2428|NCT03125018|B1|Baseline|Test Subject|All subjects are enrolled into the test group and receive the LNCS ADTX Sensor.
2429|NCT03125018|P1|Participant Flow|Test Subject|All subjects are enrolled into the test group and receive the LNCS ADTX Sensor.
2430|NCT03125018|O1|Outcome|Test Subject|All subjects are enrolled into the test group and receive the LNCS ADTX Sensor.
2431|NCT03125018|E1|Reported Event|Test Subject|All subjects are enrolled into the test group and receive the LNCS ADTX Sensor.
2432|NCT03125005|B1|Baseline|Rainbow Universal Pulse Oximeter Sensor|"All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.~Rainbow Universal Pulse Oximeter Sensor"
2433|NCT03125005|P1|Participant Flow|Rainbow Universal Pulse Oximeter Sensor|"All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.~Rainbow Universal Pulse Oximeter Sensor"
2434|NCT03125005|O1|Outcome|Rainbow Universal Pulse Oximeter Sensor|"All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.~Rainbow Universal Pulse Oximeter Sensor"
2435|NCT03125005|E1|Reported Event|Rainbow Universal Pulse Oximeter Sensor|"All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.~Rainbow Universal Pulse Oximeter Sensor"
2436|NCT03124979|B1|Baseline|Test Subject|All subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor.
2437|NCT03124979|P1|Participant Flow|Test Subject|All subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor.
2438|NCT03124979|O1|Outcome|Test Subject|All subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor.
2439|NCT03124979|E1|Reported Event|Test Subject|All subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor.
2440|NCT03124966|B1|Baseline|Noninvasive Hemoglobin Sensor|All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.
2441|NCT03124966|P1|Participant Flow|Noninvasive Hemoglobin Sensor|All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.
2442|NCT03124966|O1|Outcome|Noninvasive Hemoglobin Sensor|All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.
2443|NCT03124966|E1|Reported Event|Noninvasive Hemoglobin Sensor|All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.
2444|NCT03124927|B1|Baseline|Test Group|All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
2445|NCT03124927|P1|Participant Flow|Test Group|All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
2446|NCT03124927|O1|Outcome|Test Group|All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
2447|NCT03124927|E1|Reported Event|Test Group|All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
2448|NCT03124901|B1|Baseline|Test Group|All subject are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
2449|NCT03124901|P1|Participant Flow|Test Group|All subject are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
2450|NCT03124901|O1|Outcome|Test Group|All subject are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
2451|NCT03124901|E1|Reported Event|Test Group|All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
2452|NCT03124836|B1|Baseline|R2-25 Sensor|"All subjects will be enrolled in the test group and will receive R2-25 Pulse Oximeter Sensor~Pulse Oximeter Sensor"
2453|NCT03124836|P1|Participant Flow|R2-25 Sensor|"All subjects will be enrolled in the test group and will receive R2-25 Pulse Oximeter Sensor~Pulse Oximeter Sensor"
2454|NCT03124836|O1|Outcome|R2-25 Sensor|"All subjects will be enrolled in the test group and will receive R2-25 Pulse Oximeter Sensor~Pulse Oximeter Sensor"
2455|NCT03124836|E1|Reported Event|R2-25 Sensor|"All subjects will be enrolled in the test group and will receive R2-25 Pulse Oximeter Sensor~Pulse Oximeter Sensor"
2456|NCT03124823|B1|Baseline|Test Subject|All subjects are enrolled into the test group and all subjects received the Rainbow DCI Sensor
2457|NCT03124823|P1|Participant Flow|Test Subject|All subjects are enrolled into the test group and all subjects received the Rainbow DCI Sensor
2458|NCT03124823|O1|Outcome|Test Subject|All subjects are enrolled into the test group and all subjects received the Rainbow DCI Sensor
2459|NCT03124823|E1|Reported Event|Test Subject|All subjects are enrolled into the test group and all subjects received the Rainbow DCI Sensor
2460|NCT03124797|B1|Baseline|RD DCI Sensor|All subjects are enrolled into the test group and all subjects received the RD DCI Sensor
2461|NCT03124797|P1|Participant Flow|RD DCI Sensor|All subjects are enrolled into the test group and all subjects received the RD DCI Sensor
2462|NCT03124797|O1|Outcome|RD DCI Sensor|All subjects are enrolled into the test group and all subjects received the RD DCI Sensor
2463|NCT03124797|E1|Reported Event|RD DCI Sensor|All subjects are enrolled into the test group and all subjects received the RD DCI Sensor
2464|NCT03124784|B1|Baseline|RD Disposable Sensors|"All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors~RD Disposable Sensors: Noninvasive pulse oximeter sensor"
2465|NCT03124784|P1|Participant Flow|RD Disposable Sensors|All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors
2466|NCT03124784|O1|Outcome|RD Disposable Sensors|All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors
2467|NCT03124784|E1|Reported Event|RD Disposable Sensors|All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors
2468|NCT03124771|B1|Baseline|Rainbow Resposable Adhesive Sensors|All subjects are enrolled into the test group and all subjects received the Rainbow Resposable Adhesive Sensor.
2469|NCT03124771|P1|Participant Flow|Rainbow Resposable Adhesive Sensor|All subjects are enrolled into the test group and all subjects received the Rainbow Resposable Adhesive Sensor.
2470|NCT03124771|O1|Outcome|Rainbow Resposable Adhesive Sensor|All subjects are enrolled into the test group and all subjects received the Rainbow Resposable Adhesive Sensor.
2471|NCT03124771|E1|Reported Event|Rainbow Resposable Adhesive Sensor|All subjects are enrolled into the test group and all subjects received the Rainbow Resposable Adhesive Sensor.
2472|NCT03124758|B1|Baseline|Noninvasive Hemoglobin Sensor|All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)
2473|NCT03124758|P1|Participant Flow|Noninvasive Hemoglobin Sensor|All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)
2474|NCT03124758|O1|Outcome|Noninvasive Hemoglobin Sensor|All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)
2475|NCT03124758|E1|Reported Event|Noninvasive Hemoglobin Sensor|All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)
2476|NCT03124693|B1|Baseline|Test Group|"All subjects are enrolled into the test group and all subjects received the Rainbow DCI pulse oximeter sensor.~Rainbow DCI pulse oximeter sensor"
2477|NCT03124693|P1|Participant Flow|Test Group|"All subjects are enrolled into the test group and all subjects received the Rainbow DCI pulse oximeter sensor.~Rainbow DCI pulse oximeter sensor"
2478|NCT03124693|O1|Outcome|Test Group|All subjects are enrolled into the test group and all subjects received the Rainbow DCI pulse oximeter sensor.
2479|NCT03124693|E1|Reported Event|Test Group|"All subjects are enrolled into the test group and all subjects received the Rainbow DCI pulse oximeter sensor.~Rainbow DCI pulse oximeter sensor"
2480|NCT03124199|B1|Baseline|Rifaximin|"Patient with Helicobacter pylori infection with standard triple therapy prescribed by clinical practice.~Rifaximin: Rifaximin 400 mg/8 h added to the standard triple therapy"
2481|NCT03124199|P1|Participant Flow|Rifaximin|"Patient with Helicobacter pylori infection with standard triple therapy prescribed by clinical practice.~Rifaximin: Rifaximin 400 mg/8 h added to the standard triple therapy"
2482|NCT03124199|O1|Outcome|Rifaximin|"Patient with Helicobacter pylori infection with standard triple therapy prescribed by clinical practice.~Rifaximin: Rifaximin 400 mg/8 h added to the standard triple therapy"
2483|NCT03124199|O1|Outcome|Rifaximin|"Patient with Helicobacter pylori infection with standard triple therapy prescribed by clinical practice.~Rifaximin: Rifaximin 400 mg/8 h added to the standard triple therapy"
2484|NCT03124199|O1|Outcome|Rifaximin|"Patient with Helicobacter pylori infection with standard triple therapy prescribed by clinical practice.~Rifaximin: Rifaximin 400 mg/8 h added to the standard triple therapy"
2485|NCT03124199|E1|Reported Event|Rifaximin|"Patient with Helicobacter pylori infection with standard triple therapy prescribed by clinical practice.~Rifaximin: Rifaximin 400 mg/8 h added to the standard triple therapy"
2486|NCT03119831|B4|Baseline|Total|Total of all reporting groups
2854|NCT03048006|E1|Reported Event|All Included Patients|All included patients underwent MRI with Dotarem
2487|NCT03119831|B3|Baseline|Group C|"Alcoholic Chlorhexidine Gluconate 0.12%~Alcoholic Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
2488|NCT03119831|B2|Baseline|Group B|"Non-alcoholic Chlorhexidine Gluconate 0.12%~Non-alcoholic Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
2489|NCT03119831|B1|Baseline|Group A|"C31G~C31G: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
2490|NCT03119831|P3|Participant Flow|Alcohol-based Chlorhexidine (Group C)|"Alcohol-based Chlorhexidine Gluconate 0.12%~Alcohol-based Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postoperatively"
2491|NCT03119831|P2|Participant Flow|Alcohol-free Chlorhexidine (Group B)|"Alcohol-free Chlorhexidine Gluconate 0.12%~Alcohol-free Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postoperatively"
2492|NCT03119831|P1|Participant Flow|C31G (Group A)|"C31G~C31G: Rinsing with 15ml for one minute twice daily for 14 days postoperatively"
2493|NCT03119831|O3|Outcome|Group C|"Alcohol-based Chlorhexidine Gluconate 0.12%~Alcohol-based Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
2494|NCT03119831|O2|Outcome|Group B|"Alcohol-free Chlorhexidine Gluconate 0.12%~Alcohol-free Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
2495|NCT03119831|O1|Outcome|Group A|"C31G~C31G: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
2496|NCT03119831|O3|Outcome|Group C|"Alcohol-based Chlorhexidine Gluconate 0.12%~Alcohol-based Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
2497|NCT03119831|O2|Outcome|Group B|"Alcohol-free Chlorhexidine Gluconate 0.12%~Alcohol-free Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
2498|NCT03119831|O1|Outcome|Group A|"C31G~C31G: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
2499|NCT03119831|O3|Outcome|Group C|"Alcohol-based Chlorhexidine Gluconate 0.12%~Alcohol-based Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
2500|NCT03119831|O2|Outcome|Group B|"Alcohol-free Chlorhexidine Gluconate 0.12%~Alcohol-free Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
2501|NCT03119831|O1|Outcome|Group A|"C31G~C31G: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
2502|NCT03119831|O3|Outcome|Group C|"Alcohol-based Chlorhexidine Gluconate 0.12%~Alcohol-based Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postoperatively"
2503|NCT03119831|O2|Outcome|Group B|"Alcohol-free Chlorhexidine Gluconate 0.12%~Alcohol-free Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postoperatively"
2504|NCT03119831|O1|Outcome|Group A|"C31G~C31G: Rinsing with 15ml for one minute twice daily for 14 days postoperatively"
2505|NCT03119831|E3|Reported Event|Group C|"Alcoholic Chlorhexidine Gluconate 0.12%~Alcoholic Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
2506|NCT03119831|E2|Reported Event|Group B|"Non-alcoholic Chlorhexidine Gluconate 0.12%~Non-alcoholic Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
2507|NCT03119831|E1|Reported Event|Group A|"C31G~C31G: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
2508|NCT03115853|B1|Baseline|All Participants|
2509|NCT03115853|P1|Participant Flow|All Participants|all participants enrolled in the study
2510|NCT03115853|O3|Outcome|HCTZ and Placebo|HCTZ 25 mg po plus Placebo.
2511|NCT03115853|O2|Outcome|HCTZ Plus Aliskiren 300mg|HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
2512|NCT03115853|O1|Outcome|HCTZ Plus Aliskiren 150mg|HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
2513|NCT03115853|O3|Outcome|HCTZ and Placebo|HCTZ 25 mg po plus Placebo.
2514|NCT03115853|O2|Outcome|HCTZ Plus Aliskiren 300mg|HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
2515|NCT03115853|O1|Outcome|HCTZ Plus Aliskiren 150mg|HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
2516|NCT03115853|O3|Outcome|HCTZ and Placebo|HCTZ 25 mg po plus Placebo.
2517|NCT03115853|O2|Outcome|HCTZ Plus Aliskiren 300mg|HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
2518|NCT03115853|O1|Outcome|HCTZ Plus Aliskiren 150mg|HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
2519|NCT03115853|O3|Outcome|HCTZ and Placebo|HCTZ 25 mg po plus Placebo.
2520|NCT03115853|O2|Outcome|HCTZ Plus Aliskiren 300mg|HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
2521|NCT03115853|O1|Outcome|HCTZ Plus Aliskiren 150mg|HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
2522|NCT03115853|O3|Outcome|HCTZ and Placebo|HCTZ 25 mg po plus Placebo.
2523|NCT03115853|O2|Outcome|HCTZ Plus Aliskiren 300mg|HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
2524|NCT03115853|O1|Outcome|HCTZ Plus Aliskiren 150mg|HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
2525|NCT03115853|E1|Reported Event|All Participants|
2526|NCT03109769|B3|Baseline|Total|Total of all reporting groups
2527|NCT03109769|B2|Baseline|Verbal Oral Hygiene Instructions|"Subjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.~Verbal oral hygiene instructions"
2528|NCT03109769|B1|Baseline|Mobile Phone Application|"Subjects in this group received a mobile phone application that sends active reminder notifications of oral hygiene 3 times a day.~Mobile phone application"
2529|NCT03109769|P2|Participant Flow|Verbal Oral Hygiene Instructions|"Subjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.~Verbal oral hygiene instructions"
2855|NCT03047447|B4|Baseline|Total|Total of all reporting groups
3739|NCT02967354|O1|Outcome|Healthy Control|Healthy control.
2530|NCT03109769|P1|Participant Flow|Mobile Phone Application|"Subjects in this group received a mobile phone application that sends active reminder notifications of oral hygiene 3 times a day.~Mobile phone application"
2531|NCT03109769|O2|Outcome|Verbal Oral Hygiene Instructions|"Subjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.~Verbal oral hygiene instructions"
2532|NCT03109769|O1|Outcome|Mobile Phone Application|"Subjects in this group received a mobile phone application that sends active reminder notifications of oral hygiene 3 times a day.~Mobile phone application"
2533|NCT03109769|O2|Outcome|Verbal Oral Hygiene Instructions|"Subjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.~Verbal oral hygiene instructions"
2534|NCT03109769|O1|Outcome|Mobile Phone Application|"Subjects in this group received a mobile phone application that sends active reminder notifications of oral hygiene 3 times a day.~Mobile phone application"
2535|NCT03109769|E2|Reported Event|Verbal Oral Hygiene Instructions|"Subjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.~Verbal oral hygiene instructions"
2536|NCT03109769|E1|Reported Event|Mobile Phone Application|"Subjects in this group received a mobile phone application that sends active reminder notifications of oral hygiene 3 times a day.~Mobile phone application"
2537|NCT03106870|B3|Baseline|Total|Total of all reporting groups
2538|NCT03106870|B2|Baseline|Insulin Therapy Only|"Intervention 'Insulin Mixtard' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration."
2539|NCT03106870|B1|Baseline|Oral Metformin and Insulin|"Intervention 'Insulin Mixtard' and Intervention 'metformin' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.~Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.~If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day."
2540|NCT03106870|P2|Participant Flow|Insulin Therapy Only|"Intervention 'Insulin Mixtard' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration."
2541|NCT03106870|P1|Participant Flow|Oral Metformin and Insulin|"Intervention 'Insulin Mixtard' and Intervention 'metformin' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.~Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.~If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day."
2542|NCT03106870|O2|Outcome|Insulin Therapy Only|"Intervention 'Insulin Mixtard' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration."
2543|NCT03106870|O1|Outcome|Oral Metformin and Insulin|"Intervention 'Insulin Mixtard' and Intervention 'metformin' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.~Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.~If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day."
2544|NCT03106870|O2|Outcome|Insulin Therapy Only|"Intervention 'Insulin Mixtard' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration."
2545|NCT03106870|O1|Outcome|Oral Metformin and Insulin|"Intervention 'Insulin Mixtard' and Intervention 'metformin' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.~Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.~If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day."
2546|NCT03106870|O2|Outcome|Insulin Therapy Only|"Intervention 'Insulin Mixtard' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration."
2547|NCT03106870|O1|Outcome|Oral Metformin and Insulin|"Intervention 'Insulin Mixtard' and Intervention 'metformin' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.~Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.~If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day."
2548|NCT03106870|E2|Reported Event|Insulin Therapy Only|"Intervention 'Insulin Mixtard' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration."
2549|NCT03106870|E1|Reported Event|Oral Metformin and Insulin|"Intervention 'Insulin Mixtard' and Intervention 'metformin' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.~Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.~If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day."
2880|NCT03046225|B3|Baseline|Total|Total of all reporting groups
11511|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
2550|NCT03106337|B1|Baseline|Shear-Wave Elastography|Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.
2551|NCT03106337|P1|Participant Flow|Shear-Wave Elastography|Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.
2552|NCT03106337|O2|Outcome|Shear-Wave Elastography, Malignant Lesions|Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision. This cohort Includes all participants with malignant lesions.
2553|NCT03106337|O1|Outcome|Shear-Wave Elastography, Benign Lesions|Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision. This cohort includes all participants with benign lesions.
2554|NCT03106337|E1|Reported Event|Shear-Wave Elastography|Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.
2555|NCT03105518|B1|Baseline|Analgesia Options|"Protocolized analgesia based on VAS degree of discomfort and time. Analgesic options include heating pad, acetaminophen, percocet (oxycodone), fentanyl 0.5-1 mcg/kg.~Fentanyl: 0.5, 1 mcg/kg~Acetaminophen: Single + Oxycodone~Oxycodone: With Acetaminophen"
2556|NCT03105518|P1|Participant Flow|Analgesia Options|"Protocolized analgesia based on VAS degree of discomfort and time. Analgesic options include heating pad, acetaminophen, percocet (oxycodone), fentanyl 0.5-1 mcg/kg.~Fentanyl: 0.5, 1 mcg/kg~Acetaminophen: Single + Oxycodone~Oxycodone: With Acetaminophen"
2557|NCT03105518|O1|Outcome|Analgesia Options|"Protocolized analgesia based on VAS degree of discomfort and time. Analgesic options include heating pad, acetaminophen, percocet (oxycodone), fentanyl 0.5-1 mcg/kg.~Fentanyl: 0.5, 1 mcg/kg~Acetaminophen: Single + Oxycodone~Oxycodone: With Acetaminophen"
2558|NCT03105518|O1|Outcome|Analgesia Options|"Protocolized analgesia based on VAS degree of discomfort and time. Analgesic options include heating pad, acetaminophen, percocet (oxycodone), fentanyl 0.5-1 mcg/kg.~Fentanyl: 0.5, 1 mcg/kg~Acetaminophen: Single + Oxycodone~Oxycodone: With Acetaminophen"
2559|NCT03105518|E1|Reported Event|Analgesia Options|"Protocolized analgesia based on VAS degree of discomfort and time. Analgesic options include heating pad, acetaminophen, percocet (oxycodone), fentanyl 0.5-1 mcg/kg.~Fentanyl: 0.5, 1 mcg/kg~Acetaminophen: Single + Oxycodone~Oxycodone: With Acetaminophen~No Adverse Events in any subject"
2560|NCT03098966|B1|Baseline|Trial Of Labour After Caesarean Section|"The following data was gathered (whenever available), tabulated and subjected to the proper statistical analysis:~-Vaginal examination on admission: Cervical status Station of presenting part Membranes status Pelvic adequacy~-Intrapartum management: Progress and duration of labor according to partogram (or admission-delivery time) Intrapartum complications; placental abruption, uterine rupture, hysterectomy, complications during surgical intervention if any~-Mode of delivery: Vaginal delivery (spontaneous, assisted, complications) Cesarean section (indication, scar dehiscence)~-Postpartum Data: Postpartum hemorrhage Blood transfusion Neonatal outcome; fetal weight, birth trauma, Neonatal Intensive Care Unit admission, mortality"
2561|NCT03098966|P1|Participant Flow|Trial Of Labour After Caesarean Section|"The following data was gathered (whenever available), tabulated and subjected to the proper statistical analysis:~-Vaginal examination on admission: Cervical status Station of presenting part Membranes status Pelvic adequacy~-Intrapartum management: Progress and duration of labor according to partogram (or admission-delivery time) Intrapartum complications; placental abruption, uterine rupture, hysterectomy, complications during surgical intervention if any~-Mode of delivery: Vaginal delivery (spontaneous, assisted, complications) Cesarean section (indication, scar dehiscence)~-Postpartum Data: Postpartum hemorrhage Blood transfusion Neonatal outcome; fetal weight, birth trauma, Neonatal Intensive Care Unit admission, mortality"
2562|NCT03098966|O1|Outcome|Trial Of Labour After Caesarean Section|"The following data was gathered (whenever available), tabulated and subjected to the proper statistical analysis:~-Vaginal examination on admission: Cervical status Station of presenting part Membranes status Pelvic adequacy~-Intrapartum management: Progress and duration of labor according to partogram (or admission-delivery time) Intrapartum complications; placental abruption, uterine rupture, hysterectomy, complications during surgical intervention if any~-Mode of delivery: Vaginal delivery (spontaneous, assisted, complications) Cesarean section (indication, scar dehiscence)~-Postpartum Data: Postpartum hemorrhage Blood transfusion Neonatal outcome; fetal weight, birth trauma, Neonatal Intensive Care Unit admission, mortality"
2563|NCT03098966|O1|Outcome|Trial Of Labour After Caesarean Section|"The following data was gathered (whenever available), tabulated and subjected to the proper statistical analysis:~-Vaginal examination on admission: Cervical status Station of presenting part Membranes status Pelvic adequacy~-Intrapartum management: Progress and duration of labor according to partogram (or admission-delivery time) Intrapartum complications; placental abruption, uterine rupture, hysterectomy, complications during surgical intervention if any~-Mode of delivery: Vaginal delivery (spontaneous, assisted, complications) Cesarean section (indication, scar dehiscence)~-Postpartum Data: Postpartum hemorrhage Blood transfusion Neonatal outcome; fetal weight, birth trauma, Neonatal Intensive Care Unit admission, mortality"
2564|NCT03098966|O1|Outcome|Trial Of Labour After Caesarean Section|"The following data was gathered (whenever available), tabulated and subjected to the proper statistical analysis:~-Vaginal examination on admission: Cervical status Station of presenting part Membranes status Pelvic adequacy~-Intrapartum management: Progress and duration of labor according to partogram (or admission-delivery time) Intrapartum complications; placental abruption, uterine rupture, hysterectomy, complications during surgical intervention if any~-Mode of delivery: Vaginal delivery (spontaneous, assisted, complications) Cesarean section (indication, scar dehiscence)~-Postpartum Data: Postpartum hemorrhage Blood transfusion Neonatal outcome; fetal weight, birth trauma, Neonatal Intensive Care Unit admission, mortality"
2588|NCT03072719|P2|Participant Flow|Reference Dentifrice|Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer’s instructions), for at least 1 minute.
2589|NCT03072719|P1|Participant Flow|Experimental Dentifrice|Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100 parts per million [ppm] as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.
2565|NCT03098966|E1|Reported Event|Trial Of Labour After Caesarean Section|"The following data was gathered (whenever available), tabulated and subjected to the proper statistical analysis:~-Vaginal examination on admission: Cervical status Station of presenting part Membranes status Pelvic adequacy~-Intrapartum management: Progress and duration of labor according to partogram (or admission-delivery time) Intrapartum complications; placental abruption, uterine rupture, hysterectomy, complications during surgical intervention if any~-Mode of delivery: Vaginal delivery (spontaneous, assisted, complications) Cesarean section (indication, scar dehiscence)~-Postpartum Data: Postpartum hemorrhage Blood transfusion Neonatal outcome; fetal weight, birth trauma, Neonatal Intensive Care Unit admission, mortality"
2566|NCT03091751|B1|Baseline|BeneFIX|"BeneFIX is a recombinant FIX provided in a vial containing 100 IU/mL lyophilized nonacog alfa accompanied with solvent for reconstitution and injection.~BeneFIX: BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg."
2567|NCT03091751|P1|Participant Flow|BeneFIX|"BeneFIX is a recombinant FIX provided in a vial containing 100 IU/mL lyophilized nonacog alfa accompanied with solvent for reconstitution and injection.~BeneFIX: BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg."
2568|NCT03091751|O1|Outcome|BeneFIX|"BeneFIX is a recombinant FIX provided in a vial containing 100 IU/mL lyophilized nonacog alfa accompanied with solvent for reconstitution and injection.~BeneFIX: BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg."
2569|NCT03091751|O1|Outcome|BeneFIX|"BeneFIX is a recombinant FIX provided in a vial containing 100 IU/mL lyophilized nonacog alfa accompanied with solvent for reconstitution and injection.~BeneFIX: BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg."
2570|NCT03091751|O1|Outcome|BeneFIX|"BeneFIX is a recombinant FIX provided in a vial containing 100 IU/mL lyophilized nonacog alfa accompanied with solvent for reconstitution and injection.~BeneFIX: BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg."
2571|NCT03091751|O1|Outcome|BeneFIX|"BeneFIX is a recombinant FIX provided in a vial containing 100 IU/mL lyophilized nonacog alfa accompanied with solvent for reconstitution and injection.~BeneFIX: BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg."
2572|NCT03091751|O1|Outcome|BeneFIX|"BeneFIX is a recombinant FIX provided in a vial containing 100 IU/mL lyophilized nonacog alfa accompanied with solvent for reconstitution and injection.~BeneFIX: BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg."
2573|NCT03091751|E1|Reported Event|BeneFIX|"BeneFIX is a recombinant FIX provided in a vial containing 100 IU/mL lyophilized nonacog alfa accompanied with solvent for reconstitution and injection.~BeneFIX: BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg."
2574|NCT03073798|B1|Baseline|All Participants|"Roflumilast. 500 mcg of Roflumilast daily for 4 weeks, then there will be a 4 week wash-out phase (no medication) and a second 4 week period of placebo.~Roflumilast: 500 mcg of Roflumilast which is a prescription medicine used in adults with severe Chronic Obstructive Pulmonary Disease (COPD) to decrease the number of flare-ups or the worsening of COPD symptoms~Placebo: 500 mcg of placebo is used"
2575|NCT03073798|P1|Participant Flow|All Participants|Subjects underwent baseline MCC, then first received Roflumilast 500 mcg daily for 4 weeks. After a washout period of 4 weeks, they then received Placebo 500 mcg for an additional 4 weeks.
2576|NCT03073798|O2|Outcome|All Placebo MCC|Taking into account the washout period and crossover design of this study, we are presenting the results to reflect all of the MCC studies done while the participants were on placebo.
2577|NCT03073798|O1|Outcome|All Roflumilast MCC|Taking into account the washout period and crossover design of this study, we are presenting the results to reflect all of the MCC studies done while the participants were on roflumilast.
2578|NCT03073798|O2|Outcome|All Placebo MCC|Taking into account the washout period and crossover design of this study, we are presenting the results to reflect all of the MCC studies done while the participants were on placebo.
2579|NCT03073798|O1|Outcome|All Roflumilast MCC|Taking into account the washout period and crossover design of this study, we are presenting the results to reflect all of the MCC studies done while the participants were on roflumilast.
2580|NCT03073798|O2|Outcome|All Placebo MCC|Taking into account the washout period and crossover design of this study, we are presenting the results to reflect all of the MCC studies done while the participants were on placebo.
2581|NCT03073798|O1|Outcome|All Roflumilast MCC|Taking into account the washout period and crossover design of this study, we are presenting the results to reflect all of the MCC studies done while the participants were on roflumilast.
2582|NCT03073798|O2|Outcome|All Placebo MCC|Taking into account the washout period and crossover design of this study, we are presenting the results to reflect all of the MCC studies done while the participants were on placebo.
2583|NCT03073798|O1|Outcome|All Roflumilast MCC|Taking into account the washout period and crossover design of this study, we are presenting the results to reflect all of the MCC studies done while the participants were on roflumilast.
2584|NCT03073798|E1|Reported Event|All Participants|"Subjects underwent baseline MCC, then first received Roflumilast 500 mcg daily for 4 weeks. After a washout period of 4 weeks, they then received Placebo 500 mcg for an additional 4 weeks.~MCC was conducted at baseline and at the end of each 4 week medication phase."
2585|NCT03072719|B3|Baseline|Total|Total of all reporting groups
2586|NCT03072719|B2|Baseline|Reference Dentifrice|Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer’s instructions), for at least 1 minute.
2587|NCT03072719|B1|Baseline|Experimental Dentifrice|Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.
2759|NCT03057704|P2|Participant Flow|Intravenous Lidocaine: Tourniquet|"Lidocaine injection tourniquet~Lidocaine injection tourniquet: Intravenous lidocaine: tourniquet"
20015|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
2590|NCT03072719|O2|Outcome|Reference Dentifrice|Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer’s instructions), for at least 1 minute.
2591|NCT03072719|O1|Outcome|Experimental Dentifrice|Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.
2592|NCT03072719|O2|Outcome|Reference Dentifrice|Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer’s instructions), for at least 1 minute.
2593|NCT03072719|O1|Outcome|Experimental Dentifrice|Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.
2594|NCT03072719|O2|Outcome|Reference Dentifrice|Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer’s instructions), for at least 1 minute.
2595|NCT03072719|O1|Outcome|Experimental Dentifrice|Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.
2596|NCT03072719|E2|Reported Event|Reference Dentifrice|Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer’s instructions), for at least 1 minute.
2597|NCT03072719|E1|Reported Event|Experimental Dentifrice|Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.
2598|NCT03070730|B4|Baseline|Total|Total of all reporting groups
2599|NCT03070730|B3|Baseline|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2600|NCT03070730|B2|Baseline|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2601|NCT03070730|B1|Baseline|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2602|NCT03070730|P3|Participant Flow|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2603|NCT03070730|P2|Participant Flow|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2604|NCT03070730|P1|Participant Flow|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2605|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2606|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2607|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2760|NCT03057704|P1|Participant Flow|Intravenous Lidocaine: Flushed|"Lidocaine injection flushed~Lidocaine injection flushed: The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol."
2761|NCT03057704|O2|Outcome|Intravenous Lidocaine: Tourniquet|"Lidocaine injection tourniquet~Lidocaine injection tourniquet: Intravenous lidocaine: tourniquet"
2608|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2609|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2610|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2611|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2612|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2613|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2614|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2615|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2616|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2617|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2618|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2619|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2620|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2621|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2622|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2762|NCT03057704|O1|Outcome|Intravenous Lidocaine: Flushed|"Lidocaine injection flushed~Lidocaine injection flushed: The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol."
2763|NCT03057704|O2|Outcome|Intravenous Lidocaine: Tourniquet|"Lidocaine injection tourniquet~Lidocaine injection tourniquet: Intravenous lidocaine: tourniquet"
4374|NCT02939170|O2|Outcome|DT1 MF|Delefilcon A multifocal contact lenses worn bilaterally for 9 hours
2623|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2624|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2625|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2626|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2627|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2628|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2629|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2630|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2631|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2632|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2633|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2634|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2635|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2636|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2637|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2764|NCT03057704|O1|Outcome|Intravenous Lidocaine: Flushed|"Lidocaine injection flushed~Lidocaine injection flushed: The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol."
2765|NCT03057704|O2|Outcome|Intravenous Lidocaine: Tourniquet|"Lidocaine injection tourniquet~Lidocaine injection tourniquet: Intravenous lidocaine: tourniquet"
5079|NCT02870205|E1|Reported Event|GSP 301 Placebo NS|2 sprays/nostril twice daily for 14 days
2638|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2639|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2640|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2641|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2642|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2643|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2644|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2645|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2646|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2647|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2648|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2649|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2650|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2651|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2652|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2766|NCT03057704|O1|Outcome|Intravenous Lidocaine: Flushed|"Lidocaine injection flushed~Lidocaine injection flushed: The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol."
2767|NCT03057704|E2|Reported Event|Intravenous Lidocaine: Tourniquet|"Lidocaine injection tourniquet~Lidocaine injection tourniquet: Intravenous lidocaine: tourniquet"
7027|NCT02780349|E1|Reported Event|Single Arm|WIRION: Embolic Protection System
2653|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2654|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2655|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2656|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2657|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2658|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2659|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2660|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2661|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2662|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2663|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2664|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2665|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2666|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2667|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2768|NCT03057704|E1|Reported Event|Intravenous Lidocaine: Flushed|"Lidocaine injection flushed~Lidocaine injection flushed: The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol."
2769|NCT03055221|B1|Baseline|Intravenous Treprostinil|"Intravenous treprostinil was supplied as 1 mg/mL.~Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration."
2668|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2669|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2670|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2671|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2672|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2673|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2674|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2675|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2676|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2677|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2678|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2679|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2680|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2681|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2682|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2770|NCT03055221|P1|Participant Flow|Intravenous Treprostinil|"Intravenous treprostinil was supplied as 1 mg/mL.~Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration."
2881|NCT03046225|B2|Baseline|Physical Therapy|This group received only conventional physical therapy (continuous passive movement device and exercises).
7028|NCT02780167|B6|Baseline|Total|Total of all reporting groups
2683|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2684|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2685|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2686|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2687|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2688|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2689|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2690|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2691|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2692|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2693|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2694|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2695|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2696|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2697|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2771|NCT03055221|O1|Outcome|Intravenous Treprostinil|"Intravenous treprostinil was supplied as 1 mg/mL.~Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration."
2772|NCT03055221|O1|Outcome|Intravenous Treprostinil|"Intravenous treprostinil was supplied as 1 mg/mL.~Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration."
2698|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2699|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2700|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2701|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2702|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2703|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2704|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2705|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2706|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2707|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2708|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2709|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2710|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2711|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2712|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2773|NCT03055221|E1|Reported Event|Intravenous Treprostinil|"Intravenous treprostinil was supplied as 1 mg/mL.~Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration."
2774|NCT03054103|B4|Baseline|Total|Total of all reporting groups
3732|NCT02967354|O3|Outcome|Obese, Treated With Oral Antidiabetic Drugs + Insulin|BMI>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin
2713|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2714|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2715|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2716|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2717|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2718|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2719|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2720|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2721|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2722|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2723|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2724|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2725|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2726|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2727|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2775|NCT03054103|B3|Baseline|Ketamine 10 mg|"Drug: Ketamine 10 MG/ML: 1 ML~Ketamine 10 MG/ML: 1 ML: 10 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case."
2776|NCT03054103|B2|Baseline|Midazolam + Ketamine 5 mg|"Drug: Ketamine 10 MG/ML: 0.5 ML~Ketamine 10 MG/ML: 0.5 ML: 5 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case."
2728|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2729|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2730|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2731|NCT03070730|E3|Reported Event|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2732|NCT03070730|E2|Reported Event|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
2733|NCT03070730|E1|Reported Event|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
2734|NCT03069313|B1|Baseline|Arm I|"Oral Vitamin B12~Vitamin B12: Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days)"
2735|NCT03069313|P1|Participant Flow|Arm I|"Oral Vitamin B12~Vitamin B12: Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days)"
2736|NCT03069313|O1|Outcome|Arm I|"Oral Vitamin B12~Vitamin B12: Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days)"
2737|NCT03069313|O1|Outcome|Arm I|"Oral Vitamin B12~Vitamin B12: Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days)"
2738|NCT03069313|O1|Outcome|Arm I|"Oral Vitamin B12~Vitamin B12: Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days)"
2739|NCT03069313|O1|Outcome|Arm I|"Oral Vitamin B12~Vitamin B12: Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days)"
2740|NCT03069313|E1|Reported Event|Arm I|"Oral Vitamin B12~Vitamin B12: Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days)"
2741|NCT03065933|B1|Baseline|Clonidine as an Antimanic Agent|"Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.~extended-release clonidine: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study."
2742|NCT03065933|P1|Participant Flow|Clonidine as an Antimanic Agent|"Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.~extended-release clonidine: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study."
2743|NCT03065933|O1|Outcome|Clonidine as an Antimanic Agent|"Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.~extended-release clonidine: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study."
2744|NCT03065933|E1|Reported Event|Clonidine as an Antimanic Agent|"Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.~extended-release clonidine: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study."
2745|NCT03061513|B3|Baseline|Total|Total of all reporting groups
2746|NCT03061513|B2|Baseline|Placebo|"Placebo daily for 24 weeks~Placebo: placebo"
2747|NCT03061513|B1|Baseline|Ubiquinol|"600mg ubiquinol daily for 24 weeks~Ubiquinol: Ubiquinol caplets 600mg/day"
2748|NCT03061513|P2|Participant Flow|Placebo|"Placebo daily for 24 weeks~Placebo: placebo"
2749|NCT03061513|P1|Participant Flow|Ubiquinol|"600mg ubiquinol daily for 24 weeks~Ubiquinol: Ubiquinol caplets 600mg/day"
2750|NCT03061513|O2|Outcome|Placebo|"Placebo daily for 24 weeks~Placebo: placebo"
2751|NCT03061513|O1|Outcome|Ubiquinol|"600mg ubiquinol daily for 24 weeks~Ubiquinol: Ubiquinol caplets 600mg/day"
2752|NCT03061513|O2|Outcome|Placebo|"Placebo daily for 24 weeks~Placebo: placebo"
2753|NCT03061513|O1|Outcome|Ubiquinol|"600mg ubiquinol daily for 24 weeks~Ubiquinol: Ubiquinol caplets 600mg/day"
2754|NCT03061513|E2|Reported Event|Placebo|"Placebo daily for 24 weeks~Placebo: placebo"
2755|NCT03061513|E1|Reported Event|Ubiquinol|"600mg ubiquinol daily for 24 weeks~Ubiquinol: Ubiquinol caplets 600mg/day"
2756|NCT03057704|B3|Baseline|Total|Total of all reporting groups
2757|NCT03057704|B2|Baseline|Intravenous Lidocaine: Tourniquet|"Lidocaine injection tourniquet~Lidocaine injection tourniquet: Intravenous lidocaine: tourniquet"
2758|NCT03057704|B1|Baseline|Intravenous Lidocaine: Flushed|"Lidocaine injection flushed~Lidocaine injection flushed: The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol."
2777|NCT03054103|B1|Baseline|Midazolam Alone|"Drug: Titrated midazolam + normal saline placebo~Normal saline: Preoperative control: Normal saline placebo given preoperatively. Then protocol followed for titration of midazolam up to 2 mg IV at beginning and during case."
2778|NCT03054103|P3|Participant Flow|Midazolam + Ketamine 10 mg|"Drug: Ketamine 10 MG/ML: 1 ML~Ketamine 10 MG/ML: 1 ML: 10 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case."
2779|NCT03054103|P2|Participant Flow|Midazolam + Ketamine 5 mg|"Drug: Ketamine 10 MG/ML: 0.5 ML~Ketamine 10 MG/ML: 0.5 ML: 5 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case."
2780|NCT03054103|P1|Participant Flow|Midazolam Alone|"Drug: Titrated midazolam + normal saline placebo~Normal saline: Preoperative control: Normal saline placebo given preoperatively. Then protocol followed for titration of midazolam up to 2 mg IV at beginning and during case."
2781|NCT03054103|O3|Outcome|Ketamine 10 mg|"Drug: Ketamine 10 MG/ML: 1 ML~Ketamine 10 MG/ML: 1 ML: 10 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case."
2782|NCT03054103|O2|Outcome|Midazolam + Ketamine 5 mg|"Drug: Ketamine 10 MG/ML: 0.5 ML~Ketamine 10 MG/ML: 0.5 ML: 5 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case."
2783|NCT03054103|O1|Outcome|Midazolam Alone|"Drug: Titrated midazolam + normal saline placebo~Normal saline: Preoperative control: Normal saline placebo given preoperatively. Then protocol followed for titration of midazolam up to 2 mg IV at beginning and during case."
2784|NCT03054103|O3|Outcome|Ketamine 10 mg|"Drug: Ketamine 10 MG/ML: 1 ML~Ketamine 10 MG/ML: 1 ML: 10 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case."
2785|NCT03054103|O2|Outcome|Midazolam + Ketamine 5 mg|"Drug: Ketamine 10 MG/ML: 0.5 ML~Ketamine 10 MG/ML: 0.5 ML: 5 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case."
2786|NCT03054103|O1|Outcome|Midazolam Alone|"Drug: Titrated midazolam + normal saline placebo~Normal saline: Preoperative control: Normal saline placebo given preoperatively. Then protocol followed for titration of midazolam up to 2 mg IV at beginning and during case."
2787|NCT03054103|O3|Outcome|Ketamine 10 mg|"Drug: Ketamine 10 MG/ML: 1 ML~Ketamine 10 MG/ML: 1 ML: 10 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case."
2788|NCT03054103|O2|Outcome|Midazolam + Ketamine 5 mg|"Drug: Ketamine 10 MG/ML: 0.5 ML~Ketamine 10 MG/ML: 0.5 ML: 5 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case."
2789|NCT03054103|O1|Outcome|Midazolam Alone|"Drug: Titrated midazolam + normal saline placebo~Normal saline: Preoperative control: Normal saline placebo given preoperatively. Then protocol followed for titration of midazolam up to 2 mg IV at beginning and during case."
2790|NCT03054103|O3|Outcome|Ketamine 10 mg|"Drug: Ketamine 10 MG/ML: 1 ML~Ketamine 10 MG/ML: 1 ML: 10 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case."
2791|NCT03054103|O2|Outcome|Midazolam + Ketamine 5 mg|"Drug: Ketamine 10 MG/ML: 0.5 ML~Ketamine 10 MG/ML: 0.5 ML: 5 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case."
2792|NCT03054103|O1|Outcome|Midazolam Alone|"Drug: Titrated midazolam + normal saline placebo~Normal saline: Preoperative control: Normal saline placebo given preoperatively. Then protocol followed for titration of midazolam up to 2 mg IV at beginning and during case."
2793|NCT03054103|E3|Reported Event|Ketamine 10 mg|"Drug: Ketamine 10 MG/ML: 1 ML~Ketamine 10 MG/ML: 1 ML: 10 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case."
2794|NCT03054103|E2|Reported Event|Midazolam + Ketamine 5 mg|"Drug: Ketamine 10 MG/ML: 0.5 ML~Ketamine 10 MG/ML: 0.5 ML: 5 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case."
2795|NCT03054103|E1|Reported Event|Midazolam Alone|"Drug: Titrated midazolam + normal saline placebo~Normal saline: Preoperative control: Normal saline placebo given preoperatively. Then protocol followed for titration of midazolam up to 2 mg IV at beginning and during case."
2796|NCT03054077|B3|Baseline|Total|Total of all reporting groups
2797|NCT03054077|B2|Baseline|Intervention Group or Group 2|"This group receives an iPad with downloaded games to play while waiting for the sedation/procedure and then resume play upon return to the recovery area and awakening.~iPad with downloaded games: iPad with downloaded games will be given to children randomized to group 2 for use during their time in the peri-operative unit"
2798|NCT03054077|B1|Baseline|Control or Group 1|This group receives standard of care for the child receiving a sedated procedure. There is no intervention for this group.
2799|NCT03054077|P2|Participant Flow|Intervention Group or Group 2|"This group receives an iPad with downloaded games to play while waiting for the sedation/procedure and then resume play upon return to the recovery area and awakening.~iPad with downloaded games: iPad with downloaded games will be given to children randomized to group 2 for use during their time in the peri-operative unit"
2800|NCT03054077|P1|Participant Flow|Control or Group 1|This group receives standard of care for the child receiving a sedated procedure. There is no intervention for this group.
2801|NCT03054077|O2|Outcome|Intervention Group or Group 2|"This group receives an iPad with downloaded games to play while waiting for the sedation/procedure and then resume play upon return to the recovery area and awakening.~iPad with downloaded games: iPad with downloaded games will be given to children randomized to group 2 for use during their time in the peri-operative unit"
2802|NCT03054077|O1|Outcome|Control or Group 1|This group receives standard of care for the child receiving a sedated procedure. There is no intervention for this group.
2803|NCT03054077|E2|Reported Event|Intervention Group or Group 2|"This group receives an iPad with downloaded games to play while waiting for the sedation/procedure and then resume play upon return to the recovery area and awakening.~iPad with downloaded games: iPad with downloaded games will be given to children randomized to group 2 for use during their time in the peri-operative unit"
2804|NCT03054077|E1|Reported Event|Control or Group 1|This group receives standard of care for the child receiving a sedated procedure. There is no intervention for this group.
2805|NCT03052530|B1|Baseline|Sapphire II PRO|Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters
2833|NCT03048383|B4|Baseline|Total|Total of all reporting groups
2806|NCT03052530|P1|Participant Flow|Sapphire II PRO|"Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters~Sapphire II PRO: To pre-dilate coronary arteries or bypass grafts during the subject's index procedure with Sapphire II PRO 1.0 and 1.25 PTCA dilatation catheters."
2807|NCT03052530|O1|Outcome|Sapphire II PRO|Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters
2808|NCT03052530|O1|Outcome|Sapphire II PRO|Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters
2809|NCT03052530|O1|Outcome|Sapphire II PRO|Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters
2810|NCT03052530|O1|Outcome|Sapphire II PRO|Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters
2811|NCT03052530|E1|Reported Event|Sapphire II PRO|Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters
2812|NCT03050775|B3|Baseline|Total|Total of all reporting groups
2813|NCT03050775|B2|Baseline|Standard Ventilator Circuit|"Standard ventilation and temperature management~Standard Ventilator Circuit: no active heat and humidification during anesthesia"
2814|NCT03050775|B1|Baseline|Heated Ventilator Circuit|"Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management.~Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger"
2815|NCT03050775|P2|Participant Flow|Standard Ventilator Circuit|"Standard ventilation and temperature management~Standard Ventilator Circuit: no active heat and humidification during anesthesia"
2816|NCT03050775|P1|Participant Flow|Heated Ventilator Circuit|"Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management.~Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger"
2817|NCT03050775|O2|Outcome|Standard Ventilator Circuit|"Standard ventilation and temperature management~Standard Ventilator Circuit: no active heat and humidification during anesthesia"
2818|NCT03050775|O1|Outcome|Heated Ventilator Circuit|"Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management.~Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger"
2819|NCT03050775|O2|Outcome|Standard Ventilator Circuit|"Standard ventilation and temperature management~Standard Ventilator Circuit: no active heat and humidification during anesthesia"
2820|NCT03050775|O1|Outcome|Heated Ventilator Circuit|"Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management.~Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger"
2821|NCT03050775|O2|Outcome|Standard Ventilator Circuit|"Standard ventilation and temperature management~Standard Ventilator Circuit: no active heat and humidification during anesthesia"
2822|NCT03050775|O1|Outcome|Heated Ventilator Circuit|"Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management.~Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger"
2823|NCT03050775|O2|Outcome|Standard Ventilator Circuit|"Standard ventilation and temperature management~Standard Ventilator Circuit: no active heat and humidification during anesthesia"
2824|NCT03050775|O1|Outcome|Heated Ventilator Circuit|"Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management.~Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger"
2825|NCT03050775|O2|Outcome|Standard Ventilator Circuit|"Standard ventilation and temperature management~Standard Ventilator Circuit: no active heat and humidification during anesthesia"
2826|NCT03050775|O1|Outcome|Heated Ventilator Circuit|"Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management.~Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger"
2827|NCT03050775|O2|Outcome|Standard Ventilator Circuit|"Standard ventilation and temperature management~Standard Ventilator Circuit: no active heat and humidification during anesthesia"
2828|NCT03050775|O1|Outcome|Heated Ventilator Circuit|"Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management.~Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger"
2829|NCT03050775|O2|Outcome|Standard Ventilator Circuit|"Standard ventilation and temperature management~Standard Ventilator Circuit: no active heat and humidification during anesthesia"
2830|NCT03050775|O1|Outcome|Heated Ventilator Circuit|"Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management.~Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger"
2831|NCT03050775|E2|Reported Event|Standard Ventilator Circuit|"Standard ventilation and temperature management~Standard Ventilator Circuit: no active heat and humidification during anesthesia"
2832|NCT03050775|E1|Reported Event|Heated Ventilator Circuit|"Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management.~Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger"
2834|NCT03048383|B3|Baseline|Incobotulinumtoxin A Injectable Product|"incobotulinumtoxinA (Xeomin®, Merz) administered for n=10 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~Incobotulinumtoxin A Injectable Product: Administered to treat facial synkinesis"
2835|NCT03048383|B2|Baseline|AbobotulinumtoxinA Injectable Product|"abobotulinumtoxinA (Dysport®, Medicis) administered for n=13 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~AbobotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
2836|NCT03048383|B1|Baseline|OnabotulinumtoxinA Injectable Product|"onabotulinumtoxinA (Botox®, Allergan) administered for n=15 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~OnabotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
2837|NCT03048383|P3|Participant Flow|Incobotulinumtoxin A Injectable Product|"incobotulinumtoxinA (Xeomin®, Merz) administered for n=10 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~Incobotulinumtoxin A Injectable Product: Administered to treat facial synkinesis"
2838|NCT03048383|P2|Participant Flow|AbobotulinumtoxinA Injectable Product|"abobotulinumtoxinA (Dysport®, Medicis) administered for n=13 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~AbobotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
2839|NCT03048383|P1|Participant Flow|OnabotulinumtoxinA Injectable Product|"onabotulinumtoxinA (Botox®, Allergan) administered for n=15 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~OnabotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
2840|NCT03048383|O3|Outcome|Incobotulinumtoxin A Injectable Product|"incobotulinumtoxinA (Xeomin®, Merz) administered for n=10 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~Incobotulinumtoxin A Injectable Product: Administered to treat facial synkinesis"
2841|NCT03048383|O2|Outcome|AbobotulinumtoxinA Injectable Product|"abobotulinumtoxinA (Dysport®, Medicis) administered for n=13 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~AbobotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
2842|NCT03048383|O1|Outcome|OnabotulinumtoxinA Injectable Product|"onabotulinumtoxinA (Botox®, Allergan) administered for n=15 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~OnabotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
2843|NCT03048383|O3|Outcome|Incobotulinumtoxin A Injectable Product|"incobotulinumtoxinA (Xeomin®, Merz) administered for n=10 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~Incobotulinumtoxin A Injectable Product: Administered to treat facial synkinesis"
2844|NCT03048383|O2|Outcome|AbobotulinumtoxinA Injectable Product|"abobotulinumtoxinA (Dysport®, Medicis) administered for n=13 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~AbobotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
2845|NCT03048383|O1|Outcome|OnabotulinumtoxinA Injectable Product|"onabotulinumtoxinA (Botox®, Allergan) administered for n=15 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~OnabotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
2846|NCT03048383|E3|Reported Event|Incobotulinumtoxin A Injectable Product|"incobotulinumtoxinA (Xeomin®, Merz) administered for n=10 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~Incobotulinumtoxin A Injectable Product: Administered to treat facial synkinesis"
2847|NCT03048383|E2|Reported Event|AbobotulinumtoxinA Injectable Product|"abobotulinumtoxinA (Dysport®, Medicis) administered for n=13 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~AbobotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
2848|NCT03048383|E1|Reported Event|OnabotulinumtoxinA Injectable Product|"onabotulinumtoxinA (Botox®, Allergan) administered for n=15 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~OnabotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
2849|NCT03048006|B1|Baseline|All Included Patients|All included patients underwent MRI with Dotarem
2850|NCT03048006|P1|Participant Flow|All Included Patients|All included patients underwent MRI with Dotarem
2856|NCT03047447|B3|Baseline|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
2857|NCT03047447|B2|Baseline|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
2858|NCT03047447|B1|Baseline|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
2859|NCT03047447|P3|Participant Flow|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
2860|NCT03047447|P2|Participant Flow|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
2861|NCT03047447|P1|Participant Flow|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
2862|NCT03047447|O3|Outcome|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
2863|NCT03047447|O2|Outcome|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
2864|NCT03047447|O1|Outcome|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
2865|NCT03047447|O3|Outcome|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
2866|NCT03047447|O2|Outcome|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
2867|NCT03047447|O1|Outcome|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
20016|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
2868|NCT03047447|O3|Outcome|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
2869|NCT03047447|O2|Outcome|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
2870|NCT03047447|O1|Outcome|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
2871|NCT03047447|O3|Outcome|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes.~p=.211"
2872|NCT03047447|O2|Outcome|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes.~p=0.11"
2873|NCT03047447|O1|Outcome|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes.~p=0.00"
2874|NCT03047447|O3|Outcome|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes.~p=.211"
2875|NCT03047447|O2|Outcome|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes.~p=0.11"
2876|NCT03047447|O1|Outcome|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes.~p=0.00"
2877|NCT03047447|E3|Reported Event|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
2878|NCT03047447|E2|Reported Event|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
2879|NCT03047447|E1|Reported Event|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
2882|NCT03046225|B1|Baseline|Electrical Stimulation|This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (continuous passive movement device and exercises).
2883|NCT03046225|P2|Participant Flow|Physical Therapy|This group received only conventional physical therapy (continuous passive movement device and exercises).
2884|NCT03046225|P1|Participant Flow|Electrical Stimulation|This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (continuous passive movement device and exercises).
2885|NCT03046225|O2|Outcome|Physical Therapy|This group received only conventional physical therapy (continuous passive movement device and exercises).
2886|NCT03046225|O1|Outcome|Electrical Stimulation|This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (continuous passive movement device and exercises).
2887|NCT03046225|O2|Outcome|Physical Therapy|This group received only conventional physical therapy (continuous passive movement device and exercises).
2888|NCT03046225|O1|Outcome|Electrical Stimulation|This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (continuous passive movement device and exercises).
2889|NCT03046225|O2|Outcome|Physical Therapy|This group received only conventional physical therapy (continuous passive movement device and exercises).
2890|NCT03046225|O1|Outcome|Electrical Stimulation|This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (continuous passive movement device and exercises).
2891|NCT03046225|E2|Reported Event|Physical Therapy|This group received only conventional physical therapy (continuous passive movement device and exercises).
2892|NCT03046225|E1|Reported Event|Electrical Stimulation|This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (continuous passive movement device and exercises).
2893|NCT03046212|B3|Baseline|Total|Total of all reporting groups
2894|NCT03046212|B2|Baseline|Physical Therapy|This group received only conventional physical therapy (exercises).
2895|NCT03046212|B1|Baseline|Electrical Stimulation|This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (exercises).
2896|NCT03046212|P2|Participant Flow|Physical Therapy|This group received only conventional physical therapy (exercises).
2897|NCT03046212|P1|Participant Flow|Electrical Stimulation|This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (exercises).
2898|NCT03046212|O2|Outcome|Physical Therapy|This group received only conventional physical therapy (exercises).
2899|NCT03046212|O1|Outcome|Electrical Stimulation|This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (exercises).
2900|NCT03046212|O2|Outcome|Physical Therapy|This group received only conventional physical therapy (exercises).
2901|NCT03046212|O1|Outcome|Electrical Stimulation|This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (exercises).
2902|NCT03046212|O2|Outcome|Physical Therapy|This group received only conventional physical therapy (exercises).
2903|NCT03046212|O1|Outcome|Electrical Stimulation|This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (exercises).
2904|NCT03046212|E2|Reported Event|Physical Therapy|This group received only conventional physical therapy (exercises).
2905|NCT03046212|E1|Reported Event|Electrical Stimulation|This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (exercises).
2906|NCT03044431|B1|Baseline|Cell Therapy Treated|"All patients/participants enrolled will undergo cell therapy~Cell therapy: Each participant will receive cell therapy with stem cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day."
2907|NCT03044431|P1|Participant Flow|Cell Therapy Treated|"All patients/participants enrolled will undergo cell therapy~Cell therapy: Each participant will receive cell therapy with stem cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day."
2908|NCT03044431|O1|Outcome|Cell Therapy Treated|"All patients/participants enrolled will undergo cell therapy~Cell therapy: Each participant will receive cell therapy with stem cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day."
2909|NCT03044431|O1|Outcome|Cell Therapy Treated|"All patients/participants enrolled will undergo cell therapy~Cell therapy: Each participant will receive cell therapy with stem cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day."
2910|NCT03044431|O1|Outcome|Cell Therapy Treated|"All patients/participants enrolled will undergo cell therapy~Cell therapy: Each participant will receive cell therapy with stem cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day."
2911|NCT03044431|O1|Outcome|Cell Therapy Treated|"All patients/participants enrolled will undergo cell therapy~Cell therapy: Each participant will receive cell therapy with stem cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day."
2912|NCT03044431|O1|Outcome|Cell Therapy Treated|"All patients/participants enrolled will undergo cell therapy~Cell therapy: Each participant will receive cell therapy with stem cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day."
2913|NCT03044431|O1|Outcome|Cell Therapy Treated|"All patients/participants enrolled will undergo cell therapy~Cell therapy: Each participant will receive cell therapy with stem cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day."
2914|NCT03044431|O1|Outcome|Cell Therapy Treated|"All patients/participants enrolled will undergo cell therapy~Cell therapy: Each participant will receive cell therapy with stem cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day."
2915|NCT03044431|E1|Reported Event|Cell Therapy Treated|"All patients/participants enrolled will undergo cell therapy~Cell therapy: Each participant will receive cell therapy with stem cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day."
2916|NCT03043534|B3|Baseline|Total|Total of all reporting groups
2917|NCT03043534|B2|Baseline|Control|Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group
2918|NCT03043534|B1|Baseline|Gel and Brush|"The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.~shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE~Brush: All subjects randomized to brush will use the brush with each shave"
2919|NCT03043534|P2|Participant Flow|Control|Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group
2920|NCT03043534|P1|Participant Flow|Gel and Brush|"The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.~shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE~Brush: All subjects randomized to brush will use the brush with each shave"
2921|NCT03043534|O2|Outcome|Control|Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group
2922|NCT03043534|O1|Outcome|Gel and Brush|"The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.~shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE~Brush: All subjects randomized to brush will use the brush with each shave"
2923|NCT03043534|O2|Outcome|Control|Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group
2924|NCT03043534|O1|Outcome|Gel and Brush|"The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.~shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE~Brush: All subjects randomized to brush will use the brush with each shave"
2925|NCT03043534|E2|Reported Event|Control|Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group
2926|NCT03043534|E1|Reported Event|Gel and Brush|"The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.~shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE~Brush: All subjects randomized to brush will use the brush with each shave"
2927|NCT03041298|B1|Baseline|All Included Patients|All included patients underwent MR mammography with Dotarem.
2928|NCT03041298|P1|Participant Flow|All Included Patients|All included patients underwent MR mammography with Dotarem.
2929|NCT03041298|O1|Outcome|All Included Patients|All included patients underwent MR mammography with Dotarem.
2930|NCT03041298|O1|Outcome|All Included Patients|All included patients underwent MR mammography with Dotarem.
2931|NCT03041298|O1|Outcome|All Included Patients|All included patients underwent MR mammography with Dotarem.
2932|NCT03041298|O1|Outcome|All Included Patients|All included patients underwent MR mammography with Dotarem.
2933|NCT03041298|O1|Outcome|All Included Patients|All included patients underwent MR mammography with Dotarem.
2934|NCT03041298|E1|Reported Event|All Included Patients|All included patients underwent MR mammography with Dotarem.
2935|NCT03039543|B3|Baseline|Total|Total of all reporting groups
2936|NCT03039543|B2|Baseline|Deep Neuromuscular Blockade|"During operation, intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade. Patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.~Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.~Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2."
2979|NCT03037541|B2|Baseline|Group 2 Placebo|"Placebo Cetaphil cream applied daily on the face for one week~Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days"
20017|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
2937|NCT03039543|B1|Baseline|Moderate Neuromuscular Blockade|"During operation, intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2). Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2.~Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.~Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2."
2938|NCT03039543|P2|Participant Flow|Deep Neuromuscular Blockade|"During operation, intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade. Patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.~Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.~Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2."
2939|NCT03039543|P1|Participant Flow|Moderate Neuromuscular Blockade|"During operation, intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2). Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2.~Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.~Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2."
2940|NCT03039543|O2|Outcome|Deep Neuromuscular Blockade|"During operation, intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade. Patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.~Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.~Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2."
2941|NCT03039543|O1|Outcome|Moderate Neuromuscular Blockade|"During operation, intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2). Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2.~Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.~Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2."
2942|NCT03039543|O2|Outcome|Deep Neuromuscular Blockade|"During operation, intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade. Patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.~Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.~Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2."
2943|NCT03039543|O1|Outcome|Moderate Neuromuscular Blockade|"During operation, intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2). Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2.~Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.~Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2."
2944|NCT03039543|O2|Outcome|Deep Neuromuscular Blockade|"During operation, intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade. Patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.~Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.~Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2."
2945|NCT03039543|O1|Outcome|Moderate Neuromuscular Blockade|"During operation, intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2). Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2.~Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.~Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2."
3733|NCT02967354|O2|Outcome|Obese With Oral Antidiabetic Drugs|BMI>30, Type 2 diabetes treated with oral antidiabetic drugs
3734|NCT02967354|O1|Outcome|Healthy Control|Healthy control.
2946|NCT03039543|O2|Outcome|Deep Neuromuscular Blockade|"During operation, intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade. Patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.~Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.~Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2."
2947|NCT03039543|O1|Outcome|Moderate Neuromuscular Blockade|"During operation, intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2). Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2.~Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.~Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2."
2948|NCT03039543|O2|Outcome|Deep Neuromuscular Blockade|"During operation, intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade. Patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.~Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.~Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2."
2949|NCT03039543|O1|Outcome|Moderate Neuromuscular Blockade|"During operation, intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2). Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2.~Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.~Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2."
2950|NCT03039543|E2|Reported Event|Deep Neuromuscular Blockade|"During operation, intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade. Patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.~Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.~Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2."
2951|NCT03039543|E1|Reported Event|Moderate Neuromuscular Blockade|"During operation, intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2). Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2.~Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.~Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2."
2952|NCT03039179|B3|Baseline|Total|Total of all reporting groups
2953|NCT03039179|B2|Baseline|Standard Care|
2954|NCT03039179|B1|Baseline|Polyurethane Foam|polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
2955|NCT03039179|P2|Participant Flow|Standard Care|Only application of the Walker in the immediate postoperative period.
2956|NCT03039179|P1|Participant Flow|Polyurethane Foam|polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
2957|NCT03039179|O2|Outcome|Standard Care|
2958|NCT03039179|O1|Outcome|Polyurethane Foam|polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
2959|NCT03039179|O2|Outcome|Standard Care|
2960|NCT03039179|O1|Outcome|Polyurethane Foam|polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
2961|NCT03039179|E2|Reported Event|Standard Care|
2962|NCT03039179|E1|Reported Event|Polyurethane Foam|polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
2963|NCT03037905|B3|Baseline|Total|Total of all reporting groups
2964|NCT03037905|B2|Baseline|Standard OR|Patients who's surgeon has been randomized into the standard operating room.
2980|NCT03037541|B1|Baseline|Group 1 Carac (Fluorouracil) 0.5% Cream|"Carac cream (fluorouracil) 0.5% applied daily on the face for one week~Carac Cream: Carac Cream will be used once daily for seven consecutive days"
2981|NCT03037541|P2|Participant Flow|Group 2 Placebo|"Placebo Cetaphil cream applied daily on the face for one week~Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days"
2982|NCT03037541|P1|Participant Flow|Group 1 Carac (Fluorouracil) 0.5% Cream|"Carac cream (fluorouracil) 0.5% applied daily on the face for one week~Carac Cream: Carac Cream will be used once daily for seven consecutive days"
3770|NCT02966509|O2|Outcome|B: Control Group Arm|All participants randomized to Arm B will receive usual oncologic care.
2965|NCT03037905|B1|Baseline|SignatureSuite OR|"Patients who's surgeon has been randomized into the SignatureSuite operating room. The intervention is the unique operating room environment created by the product.~SignatureSuite™ OR Integration System by STERIS Corporation: SignatureSuite™ OR Integration System by STERIS Corporation is a product that includes software to control the audio and visual components of the operating room in order to provide a more relaxed and calming environment for patients prior to their surgery. It automatically dims lights, plays pleasant music or sounds of nature over the in-room speakers, and provides scenes of nature on video screens stationed in viewing range of the patient. As anesthesia is administered to the patient, the system automatically adjusts the light and sound systems to come up to surgeon-preferred preset stations. The process happens in reverse as the patient emerges from general anesthesia so that they awaken in the same environment as when they arrived in the OR."
2966|NCT03037905|P2|Participant Flow|Standard OR|Patients who's surgeon has been randomized into the standard operating room.
2967|NCT03037905|P1|Participant Flow|SignatureSuite OR|"Patients who's surgeon has been randomized into the SignatureSuite operating room. The intervention is the unique operating room environment created by the product.~SignatureSuite™ OR Integration System by STERIS Corporation: SignatureSuite™ OR Integration System by STERIS Corporation is a product that includes software to control the audio and visual components of the operating room in order to provide a more relaxed and calming environment for patients prior to their surgery. It automatically dims lights, plays pleasant music or sounds of nature over the in-room speakers, and provides scenes of nature on video screens stationed in viewing range of the patient. As anesthesia is administered to the patient, the system automatically adjusts the light and sound systems to come up to surgeon-preferred preset stations. The process happens in reverse as the patient emerges from general anesthesia so that they awaken in the same environment as when they arrived in the OR."
2968|NCT03037905|O2|Outcome|Standard OR|Patients who's surgeon has been randomized into the standard operating room.
2969|NCT03037905|O1|Outcome|SignatureSuite OR|"Patients who's surgeon has been randomized into the SignatureSuite operating room. The intervention is the unique operating room environment created by the product.~SignatureSuite™ OR Integration System by STERIS Corporation: SignatureSuite™ OR Integration System by STERIS Corporation is a product that includes software to control the audio and visual components of the operating room in order to provide a more relaxed and calming environment for patients prior to their surgery. It automatically dims lights, plays pleasant music or sounds of nature over the in-room speakers, and provides scenes of nature on video screens stationed in viewing range of the patient. As anesthesia is administered to the patient, the system automatically adjusts the light and sound systems to come up to surgeon-preferred preset stations. The process happens in reverse as the patient emerges from general anesthesia so that they awaken in the same environment as when they arrived in the OR."
2970|NCT03037905|O2|Outcome|Standard OR|Patients who's surgeon has been randomized into the standard operating room.
2971|NCT03037905|O1|Outcome|SignatureSuite OR|"Patients who's surgeon has been randomized into the SignatureSuite operating room. The intervention is the unique operating room environment created by the product.~SignatureSuite™ OR Integration System by STERIS Corporation: SignatureSuite™ OR Integration System by STERIS Corporation is a product that includes software to control the audio and visual components of the operating room in order to provide a more relaxed and calming environment for patients prior to their surgery. It automatically dims lights, plays pleasant music or sounds of nature over the in-room speakers, and provides scenes of nature on video screens stationed in viewing range of the patient. As anesthesia is administered to the patient, the system automatically adjusts the light and sound systems to come up to surgeon-preferred preset stations. The process happens in reverse as the patient emerges from general anesthesia so that they awaken in the same environment as when they arrived in the OR."
2972|NCT03037905|O2|Outcome|Standard OR|Standard operating room without SignatureSuite OR Integration System by STERIS Corporation.
2973|NCT03037905|O1|Outcome|SignatureSuite OR|"The intervention is exposure to the operating room environment created by the device SignatureSuite OR Integration System by STERIS Corporation.~SignatureSuite OR Integration System by STERIS Corporation: SignatureSuite OR Integration System by STERIS Corporation is a device that controls audio and visual components of the operating room environment in order to provide a more relaxing and calming operating room environment for patients prior to surgery and on emergence from anesthesia after surgery."
2974|NCT03037905|O2|Outcome|Standard OR|Patients who's surgeon has been randomized into the standard operating room.
2975|NCT03037905|O1|Outcome|SignatureSuite OR|"Patients who's surgeon has been randomized into the SignatureSuite operating room. The intervention is the unique operating room environment created by the product.~SignatureSuite™ OR Integration System by STERIS Corporation: SignatureSuite™ OR Integration System by STERIS Corporation is a product that includes software to control the audio and visual components of the operating room in order to provide a more relaxed and calming environment for patients prior to their surgery. It automatically dims lights, plays pleasant music or sounds of nature over the in-room speakers, and provides scenes of nature on video screens stationed in viewing range of the patient. As anesthesia is administered to the patient, the system automatically adjusts the light and sound systems to come up to surgeon-preferred preset stations. The process happens in reverse as the patient emerges from general anesthesia so that they awaken in the same environment as when they arrived in the OR."
2976|NCT03037905|E2|Reported Event|Standard OR|Patients who's surgeon has been randomized into the standard operating room.
2977|NCT03037905|E1|Reported Event|SignatureSuite OR|"Patients who's surgeon has been randomized into the SignatureSuite operating room. The intervention is the unique operating room environment created by the product.~SignatureSuite™ OR Integration System by STERIS Corporation: SignatureSuite™ OR Integration System by STERIS Corporation is a product that includes software to control the audio and visual components of the operating room in order to provide a more relaxed and calming environment for patients prior to their surgery. It automatically dims lights, plays pleasant music or sounds of nature over the in-room speakers, and provides scenes of nature on video screens stationed in viewing range of the patient. As anesthesia is administered to the patient, the system automatically adjusts the light and sound systems to come up to surgeon-preferred preset stations. The process happens in reverse as the patient emerges from general anesthesia so that they awaken in the same environment as when they arrived in the OR."
2978|NCT03037541|B3|Baseline|Total|Total of all reporting groups
8322|NCT02743780|E9|Reported Event|MGV354 0.1% Part 3|1 drop in each eye for 7 days
2983|NCT03037541|O2|Outcome|Group 2 Placebo|"Placebo Cetaphil cream applied daily on the face for one week~Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days"
2984|NCT03037541|O1|Outcome|Group 1 Carac (Fluorouracil) 0.5% Cream|"Carac cream (fluorouracil) 0.5% applied daily on the face for one week~Carac Cream: Carac Cream will be used once daily for seven consecutive days"
2985|NCT03037541|O2|Outcome|Group 2 Placebo|"Placebo Cetaphil cream applied daily on the face for one week~Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days"
2986|NCT03037541|O1|Outcome|Group 1 Carac (Fluorouracil) 0.5% Cream|"Carac cream (fluorouracil) 0.5% applied daily on the face for one week~Carac Cream: Carac Cream will be used once daily for seven consecutive days"
2987|NCT03037541|E2|Reported Event|Group 2 Placebo|"Placebo Cetaphil cream applied daily on the face for one week~Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days"
2988|NCT03037541|E1|Reported Event|Group 1 Carac (Fluorouracil) 0.5% Cream|"Carac cream (fluorouracil) 0.5% applied daily on the face for one week~Carac Cream: Carac Cream will be used once daily for seven consecutive days"
2989|NCT03035955|B3|Baseline|Total|Total of all reporting groups
2990|NCT03035955|B2|Baseline|Azelaic Acid Right/No Treatment Left|azelaic acid (Finacea® Gel, 15%) twice daily on the right side side of the face and no treatment on the left side of the face
2991|NCT03035955|B1|Baseline|Azelaic Acid Left/No Treatment Right|azelaic acid (Finacea® Gel, 15%) twice daily on the left side side of the face and no treatment on the right side of the face
2992|NCT03035955|P2|Participant Flow|Azelaic Acid Right/No Treatment Left|"azelaic acid (Finacea® Gel, 15%) twice daily on the right side side of the face and no treatment on the left side of the face~Azelaic acid: 15% gel twice daily for four weeks to the right side of face"
2993|NCT03035955|P1|Participant Flow|Azelaic Acid Left/No Treatment Right|"azelaic acid (Finacea® Gel, 15%) twice daily on the left side side of the face and no treatment on the right side of the face~Azelaic acid: 15% gel twice daily for four weeks to the left side of face"
2994|NCT03035955|O2|Outcome|Azelaic Acid Right /no Treatment Left|azelaic acid (Finacea® Gel, 15%) twice daily on the right side side of the face and no treatment on the left side of the face
2995|NCT03035955|O1|Outcome|Azelaic Acid Left/no Treatment Right|azelaic acid (Finacea® Gel, 15%) twice daily on the left side side of the face and no treatment on the right side of the face
2996|NCT03035955|E2|Reported Event|no Treatment|no treatment on the other side of the face
2997|NCT03035955|E1|Reported Event|Azelaic Acid|"azelaic acid (Finacea® Gel, 15%) twice daily on either the left side or the right side of the face and no treatment on the other side of the face~Azelaic acid: 15% gel twice daily for four weeks to one side of face"
2998|NCT03035916|B4|Baseline|Total|Total of all reporting groups
2999|NCT03035916|B3|Baseline|Control|"The Control group receives standard IV-inhaled general anesthesia.~control: The Control group receives standard IV-inhaled general anesthesia."
3000|NCT03035916|B2|Baseline|Epidural Anesthesia|"The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.~Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery."
3001|NCT03035916|B1|Baseline|Transversus Abdominis Plane Block|"The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.~Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started."
3002|NCT03035916|P3|Participant Flow|Control|"The Control group receives standard IV-inhaled general anesthesia.~control: The Control group receives standard IV-inhaled general anesthesia."
3003|NCT03035916|P2|Participant Flow|Epidural Anesthesia|"The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.~Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery."
3004|NCT03035916|P1|Participant Flow|Transversus Abdominis Plane Block|"The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.~Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started."
3005|NCT03035916|O3|Outcome|Control|"The Control group receives standard IV-inhaled general anesthesia.~control: The Control group receives standard IV-inhaled general anesthesia."
3006|NCT03035916|O2|Outcome|Epidural Anesthesia|"The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.~Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery."
3007|NCT03035916|O1|Outcome|Transversus Abdominis Plane Block|"The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.~Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started."
3008|NCT03035916|O3|Outcome|Control|"The Control group receives standard IV-inhaled general anesthesia.~control: The Control group receives standard IV-inhaled general anesthesia."
3084|NCT03028987|E2|Reported Event|IIV4 Randomized|Individual twins in this group received Fluzone®: Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine).
8323|NCT02743780|E8|Reported Event|Placebo Part 2|1 drop in each eye for 7 days
3009|NCT03035916|O2|Outcome|Epidural Anesthesia|"The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.~Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery."
3010|NCT03035916|O1|Outcome|Transversus Abdominis Plane Block|"The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.~Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started."
3011|NCT03035916|O3|Outcome|Control|"The Control group receives standard IV-inhaled general anesthesia.~control: The Control group receives standard IV-inhaled general anesthesia."
3012|NCT03035916|O2|Outcome|Epidural Anesthesia|"The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.~Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery."
3013|NCT03035916|O1|Outcome|Transversus Abdominis Plane Block|"The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.~Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started."
3014|NCT03035916|O3|Outcome|Control|"The Control group receives standard IV-inhaled general anesthesia.~control: The Control group receives standard IV-inhaled general anesthesia."
3015|NCT03035916|O2|Outcome|Epidural Anesthesia|"The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.~Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery."
3016|NCT03035916|O1|Outcome|Transversus Abdominis Plane Block|"The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.~Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started."
3017|NCT03035916|O3|Outcome|Control|"The Control group receives standard IV-inhaled general anesthesia.~control: The Control group receives standard IV-inhaled general anesthesia."
3018|NCT03035916|O2|Outcome|Epidural Anesthesia|"The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.~Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery."
3019|NCT03035916|O1|Outcome|Transversus Abdominis Plane Block|"The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.~Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started."
3020|NCT03035916|O3|Outcome|Control|"The Control group receives standard IV-inhaled general anesthesia.~control: The Control group receives standard IV-inhaled general anesthesia."
3021|NCT03035916|O2|Outcome|Epidural Anesthesia|"The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.~Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery."
3022|NCT03035916|O1|Outcome|Transversus Abdominis Plane Block|"The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.~Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started."
3023|NCT03035916|O3|Outcome|Control|"The Control group receives standard IV-inhaled general anesthesia.~control: The Control group receives standard IV-inhaled general anesthesia."
3024|NCT03035916|O2|Outcome|Epidural Anesthesia|"The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.~Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery."
3025|NCT03035916|O1|Outcome|Transversus Abdominis Plane Block|"The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.~Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started."
3026|NCT03035916|O3|Outcome|Control|"The Control group receives standard IV-inhaled general anesthesia.~control: The Control group receives standard IV-inhaled general anesthesia."
4821|NCT02912650|E1|Reported Event|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
3027|NCT03035916|O2|Outcome|Epidural Anesthesia|"The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.~Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery."
3028|NCT03035916|O1|Outcome|Transversus Abdominis Plane Block|"The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.~Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started."
3029|NCT03035916|O3|Outcome|Control|"The Control group receives standard IV-inhaled general anesthesia.~control: The Control group receives standard IV-inhaled general anesthesia."
3030|NCT03035916|O2|Outcome|Epidural Anesthesia|"The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.~Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery."
3031|NCT03035916|O1|Outcome|Transversus Abdominis Plane Block|"The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.~Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started."
3032|NCT03035916|O3|Outcome|Control|"The Control group receives standard IV-inhaled general anesthesia.~control: The Control group receives standard IV-inhaled general anesthesia."
3033|NCT03035916|O2|Outcome|Epidural Anesthesia|"The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.~Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery."
3034|NCT03035916|O1|Outcome|Transversus Abdominis Plane Block|"The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.~Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started."
3035|NCT03035916|O3|Outcome|Control|"The Control group receives standard IV-inhaled general anesthesia.~control: The Control group receives standard IV-inhaled general anesthesia."
3036|NCT03035916|O2|Outcome|Epidural Anesthesia|"The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.~Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery."
3037|NCT03035916|O1|Outcome|Transversus Abdominis Plane Block|"The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.~Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started."
3038|NCT03035916|O3|Outcome|Control|"The Control group receives standard IV-inhaled general anesthesia.~control: The Control group receives standard IV-inhaled general anesthesia."
3039|NCT03035916|O2|Outcome|Epidural Anesthesia|"The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.~Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery."
3040|NCT03035916|O1|Outcome|Transversus Abdominis Plane Block|"The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.~Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started."
3041|NCT03035916|O3|Outcome|Control|"The Control group receives standard IV-inhaled general anesthesia.~control: The Control group receives standard IV-inhaled general anesthesia."
3042|NCT03035916|O2|Outcome|Epidural Anesthesia|"The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.~Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery."
3043|NCT03035916|O1|Outcome|Transversus Abdominis Plane Block|"The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.~Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started."
3044|NCT03035916|O3|Outcome|Control|"The Control group receives standard IV-inhaled general anesthesia.~control: The Control group receives standard IV-inhaled general anesthesia."
4822|NCT02910362|B3|Baseline|Total|Total of all reporting groups
3045|NCT03035916|O2|Outcome|Epidural Anesthesia|"The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.~Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery."
3046|NCT03035916|O1|Outcome|Transversus Abdominis Plane Block|"The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.~Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started."
3047|NCT03035916|E3|Reported Event|Control|"The Control group receives standard IV-inhaled general anesthesia.~control: The Control group receives standard IV-inhaled general anesthesia."
3048|NCT03035916|E2|Reported Event|Epidural Anesthesia|"The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.~Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery."
3049|NCT03035916|E1|Reported Event|Transversus Abdominis Plane Block|"The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.~Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started."
3050|NCT03032965|B3|Baseline|Total|Total of all reporting groups
3051|NCT03032965|B2|Baseline|Isoproterenol|"This group will not receive adenosine during the procedure.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
3052|NCT03032965|B1|Baseline|Adenosine and Isoproterenol|"Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.~Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.~Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
3053|NCT03032965|P2|Participant Flow|Isoproterenol|"This group will not receive adenosine during the procedure.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
3054|NCT03032965|P1|Participant Flow|Adenosine and Isoproterenol|"Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.~Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.~Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
3055|NCT03032965|O2|Outcome|Isoproterenol|"This group will not receive adenosine during the procedure.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
3056|NCT03032965|O1|Outcome|Adenosine and Isoproterenol|"Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.~Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.~Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
3057|NCT03032965|O2|Outcome|Isoproterenol|"This group will not receive adenosine during the procedure.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
3085|NCT03028987|E1|Reported Event|LAIV Randomized|Individual twins in this group received FluMist®: FluMist® Intranasal Spray (quadrivalent, live, attenuated influenza vaccine).
3086|NCT03028025|B3|Baseline|Total|Total of all reporting groups
3058|NCT03032965|O1|Outcome|Adenosine and Isoproterenol|"Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.~Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.~Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
3059|NCT03032965|O2|Outcome|Isoproterenol|"This group will not receive adenosine during the procedure.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
3060|NCT03032965|O1|Outcome|Adenosine and Isoproterenol|"Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.~Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.~Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
3061|NCT03032965|O2|Outcome|Isoproterenol|"This group will not receive adenosine during the procedure.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
3062|NCT03032965|O1|Outcome|Adenosine and Isoproterenol|"Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.~Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.~Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
3063|NCT03032965|O2|Outcome|Isoproterenol|"This group will not receive adenosine during the procedure.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
3064|NCT03032965|O1|Outcome|Adenosine and Isoproterenol|"Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.~Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.~Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
3065|NCT03032965|O2|Outcome|Isoproterenol|"This group will not receive adenosine during the procedure.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
3066|NCT03032965|O1|Outcome|Adenosine and Isoproterenol|"Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.~Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.~Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
3067|NCT03032965|O2|Outcome|Isoproterenol|"This group will not receive adenosine during the procedure.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
3141|NCT03023553|P2|Participant Flow|LAIV Group|"Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
3068|NCT03032965|O1|Outcome|Adenosine and Isoproterenol|"Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.~Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.~Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
3069|NCT03032965|O2|Outcome|Isoproterenol|"This group will not receive adenosine during the procedure.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
3070|NCT03032965|O1|Outcome|Adenosine and Isoproterenol|"Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.~Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.~Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
3071|NCT03032965|O2|Outcome|Isoproterenol|"This group will not receive adenosine during the procedure.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
3072|NCT03032965|O1|Outcome|Adenosine and Isoproterenol|"Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.~Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.~Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
3073|NCT03032965|E2|Reported Event|Isoproterenol|"This group will not receive adenosine during the procedure.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
3074|NCT03032965|E1|Reported Event|Adenosine and Isoproterenol|"Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.~Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.~Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
3075|NCT03028987|B3|Baseline|Total|Total of all reporting groups
3076|NCT03028987|B2|Baseline|IIV4 Randomized|"Individual twins are past participants who have been identified as HLA DR1501+ or DR0701+ by lab assay results. All participants will be randomized within the twin pair to receive either the seasonal quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® or the seasonal quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone®~Fluzone®: Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine)"
3077|NCT03028987|B1|Baseline|LAIV Randomized|"Individual twins are past participants who have been identified as HLA DR1501+ or DR0701+ by lab assay results. All participants will be randomized within the twin pair to receive either the seasonal quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® or the seasonal quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® .~FluMist®: FluMist® Intranasal Spray (quadrivalent, live, attenuated influenza vaccine)"
3078|NCT03028987|P2|Participant Flow|IIV4 Randomized|Individual twins in this group received Fluzone®: Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine).
3079|NCT03028987|P1|Participant Flow|LAIV Randomized|Individual twins in this group received FluMist®: FluMist® Intranasal Spray (quadrivalent, live, attenuated influenza vaccine).
3080|NCT03028987|O2|Outcome|IIV4 Randomized|Individual twins in this group received Fluzone®: Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine).
3081|NCT03028987|O1|Outcome|LAIV Randomized|Individual twins in this group received FluMist®: FluMist® Intranasal Spray (quadrivalent, live, attenuated influenza vaccine).
3082|NCT03028987|O2|Outcome|IIV4 Randomized|Individual twins in this group received Fluzone®: Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine).
3083|NCT03028987|O1|Outcome|LAIV Randomized|Individual twins in this group received FluMist®: FluMist® Intranasal Spray (quadrivalent, live, attenuated influenza vaccine).
20018|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
3087|NCT03028025|B2|Baseline|Statseal With TR Band|StatSeal: Patients randomly assigned to the experimental group will have a Statseal Advance (SSA) disc applied after withdrawing the radial sheath 2-4 cm. A Tegaderm dressing will be applied to secure the disc position. The TR band will be applied over the SSA disc with the center of the balloon (the green dot) over the center of the SSA disc. The TR band will be inflated with 8cc of air (which is typically occlusive pressure), and the sheath removed. No deflation will occur immediately. After 20 minutes of pressure, 3 cc of air will be removed from the TR band. After an additional 20 minutes (40 minutes after procedure), the TR band will be completely deflated, and the TR band left in place. After an additional 20 minutes (60 minutes after procedure) the TR band will be removed.
3088|NCT03028025|B1|Baseline|TR Band Only|TR Band: Patients randomly assigned to the control group will have a TR band applied over the arteriotomy site and inflated with 15-18ml of air. After aspirating and clearing the contents of the sheath, the radial sheath will be removed. The TR band will be deflated until bleeding occurs, and 2 ml of air will be reintroduced to provide hemostasis. Patent hemostasis will be documented with plethysmography and oximetry as described below within 5 minutes after band application and removal, and within 30 min of discharge or after 24 hours. The TR band will be left inflated and in place for 2 hours following the procedure for all patients (regardless of diagnostic or PCI procedure), after which deflation attempts will commence.
3089|NCT03028025|P2|Participant Flow|Statseal With TR Band|Patients randomly assigned to the experimental group will have a Statseal Advance (SSA) disc applied after withdrawing the radial sheath 2-4 cm. A Tegaderm dressing will be applied to secure the disc position. The TR band will be applied over the SSA disc with the center of the balloon (the green dot) over the center of the SSA disc. The TR band will be inflated with 8cc of air (which is typically occlusive pressure), and the sheath removed. No deflation will occur immediately. After 20 minutes of pressure, 3 cc of air will be removed from the TR band. After an additional 20 minutes (40 minutes after procedure), the TR band will be completely deflated, and the TR band left in place. After an additional 20 minutes (60 minutes after procedure) the TR band will be removed.
3090|NCT03028025|P1|Participant Flow|TR Band Only|Patients randomly assigned to the control group will have a TR band applied over the arteriotomy site and inflated with 15-18ml of air. After aspirating and clearing the contents of the sheath, the radial sheath will be removed. The TR band will be deflated until bleeding occurs, and 2 ml of air will be reintroduced to provide hemostasis. Patent hemostasis will be documented with plethysmography and oximetry as described below within 5 minutes after band application and removal, and within 30 min of discharge or after 24 hours. The TR band will be left inflated and in place for 2 hours following the procedure for all patients (regardless of diagnostic or PCI procedure), after which deflation attempts will commence.
3091|NCT03028025|O2|Outcome|Statseal With TR Band|Patients randomly assigned to the experimental group will have a Statseal Advance (SSA) disc applied after withdrawing the radial sheath 2-4 cm. A Tegaderm dressing will be applied to secure the disc position. The TR band will be applied over the SSA disc with the center of the balloon (the green dot) over the center of the SSA disc. The TR band will be inflated with 8cc of air (which is typically occlusive pressure), and the sheath removed. No deflation will occur immediately. After 20 minutes of pressure, 3 cc of air will be removed from the TR band. After an additional 20 minutes (40 minutes after procedure), the TR band will be completely deflated, and the TR band left in place. After an additional 20 minutes (60 minutes after procedure) the TR band will be removed.
3092|NCT03028025|O1|Outcome|TR Band Only|Patients randomly assigned to the control group will have a TR band applied over the arteriotomy site and inflated with 15-18ml of air. After aspirating and clearing the contents of the sheath, the radial sheath will be removed. The TR band will be deflated until bleeding occurs, and 2 ml of air will be reintroduced to provide hemostasis. Patent hemostasis will be documented with plethysmography and oximetry as described below within 5 minutes after band application and removal, and within 30 min of discharge or after 24 hours. The TR band will be left inflated and in place for 2 hours following the procedure for all patients (regardless of diagnostic or PCI procedure), after which deflation attempts will commence.
3093|NCT03028025|O2|Outcome|Statseal With TR Band|Patients randomly assigned to the experimental group will have a Statseal Advance (SSA) disc applied after withdrawing the radial sheath 2-4 cm. A Tegaderm dressing will be applied to secure the disc position. The TR band will be applied over the SSA disc with the center of the balloon (the green dot) over the center of the SSA disc. The TR band will be inflated with 8cc of air (which is typically occlusive pressure), and the sheath removed. No deflation will occur immediately. After 20 minutes of pressure, 3 cc of air will be removed from the TR band. After an additional 20 minutes (40 minutes after procedure), the TR band will be completely deflated, and the TR band left in place. After an additional 20 minutes (60 minutes after procedure) the TR band will be removed.
3094|NCT03028025|O1|Outcome|TR Band Only|Patients randomly assigned to the control group will have a TR band applied over the arteriotomy site and inflated with 15-18ml of air. After aspirating and clearing the contents of the sheath, the radial sheath will be removed. The TR band will be deflated until bleeding occurs, and 2 ml of air will be reintroduced to provide hemostasis. Patent hemostasis will be documented with plethysmography and oximetry as described below within 5 minutes after band application and removal, and within 30 min of discharge or after 24 hours. The TR band will be left inflated and in place for 2 hours following the procedure for all patients (regardless of diagnostic or PCI procedure), after which deflation attempts will commence.
3095|NCT03028025|E2|Reported Event|Statseal With TR Band|StatSeal: Patients randomly assigned to the experimental group will have a Statseal Advance (SSA) disc applied after withdrawing the radial sheath 2-4 cm. A Tegaderm dressing will be applied to secure the disc position. The TR band will be applied over the SSA disc with the center of the balloon (the green dot) over the center of the SSA disc. The TR band will be inflated with 8cc of air (which is typically occlusive pressure), and the sheath removed. No deflation will occur immediately. After 20 minutes of pressure, 3 cc of air will be removed from the TR band. After an additional 20 minutes (40 minutes after procedure), the TR band will be completely deflated, and the TR band left in place. After an additional 20 minutes (60 minutes after procedure) the TR band will be removed.
3142|NCT03023553|P1|Participant Flow|TIV/ Control Group|"Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.~Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3143|NCT03023553|O2|Outcome|LAIV Group|"Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
3096|NCT03028025|E1|Reported Event|TR Band Only|TR Band: Patients randomly assigned to the control group will have a TR band applied over the arteriotomy site and inflated with 15-18ml of air. After aspirating and clearing the contents of the sheath, the radial sheath will be removed. The TR band will be deflated until bleeding occurs, and 2 ml of air will be reintroduced to provide hemostasis. Patent hemostasis will be documented with plethysmography and oximetry as described below within 5 minutes after band application and removal, and within 30 min of discharge or after 24 hours. The TR band will be left inflated and in place for 2 hours following the procedure for all patients (regardless of diagnostic or PCI procedure), after which deflation attempts will commence.
3097|NCT03026803|B1|Baseline|Oxaliplatin and Capecitabine|"21 day cycle with Oxaliplatin 50mg/m^2 day 1 and day 8 administered IV, Capecitabine 750 mg/m^2 bid p.o. daily from day 1 to day 14~Oxaliplatin: Given IV~Capecitabine: Given PO"
3098|NCT03026803|P1|Participant Flow|Oxaliplatin and Capecitabine|"21 day cycle with Oxaliplatin 50mg/m^2 day 1 and day 8 administered IV, Capecitabine 750 mg/m^2 bid p.o. daily from day 1 to day 14~Oxaliplatin: Given IV~Capecitabine: Given PO"
3099|NCT03026803|O1|Outcome|Oxaliplatin and Capecitabine|"21 day cycle with Oxaliplatin 50mg/m^2 day 1 and day 8 administered IV, Capecitabine 750 mg/m^2 bid p.o. daily from day 1 to day 14~Oxaliplatin: Given IV~Capecitabine: Given PO"
3100|NCT03026803|E1|Reported Event|Oxaliplatin and Capecitabine|"21 day cycle with Oxaliplatin 50mg/m^2 day 1 and day 8 administered IV, Capecitabine 750 mg/m^2 bid p.o. daily from day 1 to day 14~Oxaliplatin: Given IV~Capecitabine: Given PO"
3101|NCT03024112|B3|Baseline|Total|Total of all reporting groups
3102|NCT03024112|B2|Baseline|Standard Oxygen Therapy|"The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%.~Standard oxygen therapy"
3103|NCT03024112|B1|Baseline|Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen|"The intervention group received HHFNC O2 at a set flow of 40L/min. FiO2 was titrated by respiratory therapists to maintain SpO2 ≥ 90%. The HHFNC O2 apparatus included: 1) Air-Oxygen blender – capable of delivering 21-100% FiO2 at flow rates up to 60L/min, 2) Heated Humidifier – providing active heating and humidification to the delivered air-O2 blend, 3) Nasal cannula – larger diameter, slightly elongated nasal cannula with single limb connection to humidifier~Heated humified high-flow nasal cannula Oxygen"
3104|NCT03024112|P2|Participant Flow|Standard Oxygen Therapy|"The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%.~Standard oxygen therapy"
3105|NCT03024112|P1|Participant Flow|Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen|"The intervention group received HHFNC O2 at a set flow of 40L/min. FiO2 was titrated by respiratory therapists to maintain SpO2 ≥ 90%. The HHFNC O2 apparatus included: 1) Air-Oxygen blender – capable of delivering 21-100% FiO2 at flow rates up to 60L/min, 2) Heated Humidifier – providing active heating and humidification to the delivered air-O2 blend, 3) Nasal cannula – larger diameter, slightly elongated nasal cannula with single limb connection to humidifier~Heated humified high-flow nasal cannula Oxygen"
3106|NCT03024112|O2|Outcome|Standard Oxygen Therapy|"The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%.~Standard oxygen therapy"
3107|NCT03024112|O1|Outcome|Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen|"The intervention group received HHFNC O2 at a set flow of 40L/min. FiO2 was titrated by respiratory therapists to maintain SpO2 ≥ 90%. The HHFNC O2 apparatus included: 1) Air-Oxygen blender – capable of delivering 21-100% FiO2 at flow rates up to 60L/min, 2) Heated Humidifier – providing active heating and humidification to the delivered air-O2 blend, 3) Nasal cannula – larger diameter, slightly elongated nasal cannula with single limb connection to humidifier~Heated humified high-flow nasal cannula Oxygen"
3108|NCT03024112|O2|Outcome|Standard Oxygen Therapy|"The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%.~Standard oxygen therapy"
3109|NCT03024112|O1|Outcome|Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen|"The intervention group received HHFNC O2 at a set flow of 40L/min. FiO2 was titrated by respiratory therapists to maintain SpO2 ≥ 90%. The HHFNC O2 apparatus included: 1) Air-Oxygen blender – capable of delivering 21-100% FiO2 at flow rates up to 60L/min, 2) Heated Humidifier – providing active heating and humidification to the delivered air-O2 blend, 3) Nasal cannula – larger diameter, slightly elongated nasal cannula with single limb connection to humidifier~Heated humified high-flow nasal cannula Oxygen"
3110|NCT03024112|O2|Outcome|Standard Oxygen Therapy|"The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%.~Standard oxygen therapy"
3111|NCT03024112|O1|Outcome|Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen|"The intervention group received HHFNC O2 at a set flow of 40L/min. FiO2 was titrated by respiratory therapists to maintain SpO2 ≥ 90%. The HHFNC O2 apparatus included: 1) Air-Oxygen blender – capable of delivering 21-100% FiO2 at flow rates up to 60L/min, 2) Heated Humidifier – providing active heating and humidification to the delivered air-O2 blend, 3) Nasal cannula – larger diameter, slightly elongated nasal cannula with single limb connection to humidifier~Heated humified high-flow nasal cannula Oxygen"
3112|NCT03024112|O2|Outcome|Standard Oxygen Therapy|"The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%.~Standard oxygen therapy"
3113|NCT03024112|O1|Outcome|Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen|"The intervention group received HHFNC O2 at a set flow of 40L/min. FiO2 was titrated by respiratory therapists to maintain SpO2 ≥ 90%. The HHFNC O2 apparatus included: 1) Air-Oxygen blender – capable of delivering 21-100% FiO2 at flow rates up to 60L/min, 2) Heated Humidifier – providing active heating and humidification to the delivered air-O2 blend, 3) Nasal cannula – larger diameter, slightly elongated nasal cannula with single limb connection to humidifier~Heated humified high-flow nasal cannula Oxygen"
3114|NCT03024112|E2|Reported Event|Standard Oxygen Therapy|"The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%.~Standard oxygen therapy"
3144|NCT03023553|O1|Outcome|TIV/ Control Group|"Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.~Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3735|NCT02967354|O5|Outcome|Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin|BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin
3115|NCT03024112|E1|Reported Event|Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen|"The intervention group received HHFNC O2 at a set flow of 40L/min. FiO2 was titrated by respiratory therapists to maintain SpO2 ≥ 90%. The HHFNC O2 apparatus included: 1) Air-Oxygen blender – capable of delivering 21-100% FiO2 at flow rates up to 60L/min, 2) Heated Humidifier – providing active heating and humidification to the delivered air-O2 blend, 3) Nasal cannula – larger diameter, slightly elongated nasal cannula with single limb connection to humidifier~Heated humified high-flow nasal cannula Oxygen"
3116|NCT03023709|B3|Baseline|Total|Total of all reporting groups
3117|NCT03023709|B2|Baseline|Study Phase (LAIV4)|"Participants will be given quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4), FluMist®, intranasally 3-14 days prior to tonsillectomy.~FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray"
3118|NCT03023709|B1|Baseline|Pilot Phase (IIV4)|"Participants will receive the seasonal quadrivalent, inactivated influenza vaccine (IIV4), Fluzone®, given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.~Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular"
3119|NCT03023709|P2|Participant Flow|Study Phase (LAIV4)|"Participants will be given the quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4), FluMist®, intranasally 3-14 days prior to tonsillectomy.~FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray"
3120|NCT03023709|P1|Participant Flow|Pilot Phase (IIV4)|"Participants will receive the seasonal quadrivalent, inactivated influenza vaccine (IIV4), Fluzone®, given intramuscularly to confirm the safety of administering licensed seasonal influenza vaccine 3-14 days prior to tonsillectomy.~Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular"
3121|NCT03023709|O2|Outcome|Study Phase (LAIV4)|"Participants will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy.~FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray"
3122|NCT03023709|O1|Outcome|Pilot Phase (IIV4)|"Participants will receive the current seasonal quadrivalent, inactivated influenza vaccine (IIV4)/Fluzone® given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.~Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular"
3123|NCT03023709|O2|Outcome|Study Phase|"Participants will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy.~FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray"
3124|NCT03023709|O1|Outcome|Pilot Phase|"Participants will receive the current seasonal quadrivalent, inactivated influenza vaccine (IIV4)/Fluzone® given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.~Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular"
3125|NCT03023709|E2|Reported Event|Study Phase (LAIV4)|"Participants will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy.~FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray"
3126|NCT03023709|E1|Reported Event|Pilot Phase (IIV4)|"Participants will receive the current seasonal quadrivalent, inactivated influenza vaccine (IIV4)/Fluzone® given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.~Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular"
3127|NCT03023683|B3|Baseline|Total|Total of all reporting groups
3128|NCT03023683|B2|Baseline|Group B: 18-49 yo Healthy Non-twins|"Participants will be given seasonal LAIV, FluMist® .~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
3129|NCT03023683|B1|Baseline|Group A: 2-8 yo Healthy Non-twins|"Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
3130|NCT03023683|P2|Participant Flow|Group B: 18-49 yo Healthy Non-twins|"Participants will be given seasonal LAIV, FluMist® .~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
3131|NCT03023683|P1|Participant Flow|Group A: 2-8 yo Healthy Non-twins|"Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
3132|NCT03023683|O2|Outcome|Group B: 18-49 yo Healthy Non-twins|"Participants will be given seasonal LAIV, FluMist® .~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
3133|NCT03023683|O1|Outcome|Group A: 2-8 yo Healthy Non-twins|"Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
3134|NCT03023683|O2|Outcome|Group B: 18-49 yo Healthy Non-twins|"Participants will be given seasonal LAIV, FluMist® .~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
3135|NCT03023683|O1|Outcome|Group A: 2-8 yo Healthy Non-twins|"Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
3136|NCT03023683|E2|Reported Event|Group B: 18-49 yo Healthy Non-twins|"Participants will be given seasonal LAIV, FluMist® .~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
3137|NCT03023683|E1|Reported Event|Group A: 2-8 yo Healthy Non-twins|"Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
3138|NCT03023553|B3|Baseline|Total|Total of all reporting groups
3139|NCT03023553|B2|Baseline|LAIV Group|"Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
3140|NCT03023553|B1|Baseline|TIV/ Control Group|"Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.~Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection"
8324|NCT02743780|E7|Reported Event|MGV354 0.1% Part 2|1 drop in each eye for 7 days
3145|NCT03023553|O2|Outcome|LAIV Group|"Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
3146|NCT03023553|O1|Outcome|TIV/ Control Group|"Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.~Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3147|NCT03023553|E2|Reported Event|LAIV Group|"Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
3148|NCT03023553|E1|Reported Event|TIV/ Control Group|"Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.~Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3149|NCT03023488|B1|Baseline|Flexible Ureteroscopy Arm|"findings of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
3150|NCT03023488|P1|Participant Flow|Flexible Ureteroscopy Arm|"Doppler Ultrasound examination was performed in both the pre-operative and post-operative periods on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
3151|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"The number of patients who had a complication after the flexible ureteroscopy operation in the first month following the operation.~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
3152|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"The number of patients that had a complication intraoperatively.~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
3153|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"The pressure applied to the irrigation solution during a flexible ureteroscopy operation~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
3154|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"The duration of the flexible ureteroscopy operation~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
3155|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"The type of the ureteroscope used for the flexible ureteroscopy operation~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
3224|NCT03022422|B5|Baseline|Group F: 65-100 yo Identical Twins (TIV)|Individual twins will receive Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection
20019|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
3156|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
3157|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
3158|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
3159|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
3160|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
3161|NCT03023488|E1|Reported Event|Flexible Ureteroscopy Arm|"findings of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
3162|NCT03023176|B1|Baseline|Healthy 1-8 Year-old Twins|"Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.~Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection~Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection"
3163|NCT03023176|P1|Participant Flow|Healthy 1-8 Year-old Twins|"Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.~Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection~Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection"
3164|NCT03023176|O1|Outcome|Healthy 1-8 Year-old Twins|"Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.~Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection~Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection"
3225|NCT03022422|B4|Baseline|Group E: 40-64 yo Fraternal Twins (TIV)|"Individual twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
8325|NCT02743780|E6|Reported Event|MGV354 0.03% Part 2|1 drop in each eye for 7 days
3165|NCT03023176|O1|Outcome|Healthy 1-8 Year-old Twins|"Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.~Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection~Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection"
3166|NCT03023176|E1|Reported Event|Healthy 1-8 Year-old Twins|"Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.~Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection~Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection"
3167|NCT03023137|B3|Baseline|Total|Total of all reporting groups
3168|NCT03023137|B2|Baseline|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
3169|NCT03023137|B1|Baseline|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrolment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water or sugar-sweetened beverages. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
3170|NCT03023137|P2|Participant Flow|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
3171|NCT03023137|P1|Participant Flow|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
3172|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
3173|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
3174|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
3175|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
3176|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
3177|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
3178|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
3226|NCT03022422|B3|Baseline|Group D: 40-64 yo Identical Twins (TIV)|"Individual twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3179|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
3180|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
3181|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
3182|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
3183|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
3184|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
3185|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
3186|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
3187|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
3188|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
3189|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
3190|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
3227|NCT03022422|B2|Baseline|Group C: 18-30 yo Fraternal Twins (TIV)|"Individual twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
20020|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
3191|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
3192|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
3193|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages and large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
3194|NCT03023137|E2|Reported Event|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
3195|NCT03023137|E1|Reported Event|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet will be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
3196|NCT03022435|B6|Baseline|Total|Total of all reporting groups
3197|NCT03022435|B5|Baseline|Group F: 65 - 100 yo Identical Twins (High-Dose TIV)|Participants to receive High-Dose Fluzone® standard TIV
3198|NCT03022435|B4|Baseline|Group F: 65 - 100 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
3199|NCT03022435|B3|Baseline|Group D: 40 - 64 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
3200|NCT03022435|B2|Baseline|Group B: 18-30 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
3201|NCT03022435|B1|Baseline|Group B: 18-30 yo Identical Twins (LAIV)|Participants to receive FluMist® LAIV by nasal spray.
3202|NCT03022435|P5|Participant Flow|Group F: 65-100 yo Identical Twins (High-Dose TIV)|Participants to receive High-Dose Fluzone® standard TIV
3203|NCT03022435|P4|Participant Flow|Group F: 65-100 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
3204|NCT03022435|P3|Participant Flow|Group D: 40 - 64 yo Identical Twins|Participants to receive Fluzone® standard TIV
3205|NCT03022435|P2|Participant Flow|Group B: 18-30 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
3206|NCT03022435|P1|Participant Flow|Group B: 18-30 yo Identical Twins (LAIV)|Participants to receive FluMist® LAIV by nasal spray.
3207|NCT03022435|O5|Outcome|Group F: 65 - 100 yo Identical Twins (High Dose TIV)|Participants to receive High-Dose Fluzone® standardTIV
3208|NCT03022435|O4|Outcome|Group F: 65 - 100 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
3209|NCT03022435|O3|Outcome|Group D: 40 - 64 yo Identical Twins|Participants to receive Fluzone® standard TIV
3210|NCT03022435|O2|Outcome|Group B: 18-30 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
3211|NCT03022435|O1|Outcome|Group B: 18-30 yo Identical Twins (LAIV)|Participants to receive FluMist® LAIV by nasal spray
3212|NCT03022435|O5|Outcome|Group F: 65 - 100 yo Identical Twins (High-Dose TIV)|Participants to receive High-Dose Fluzone® standard TIV
3213|NCT03022435|O4|Outcome|Group F: 65 - 100 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
3214|NCT03022435|O3|Outcome|Group D: 40 - 64 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
3215|NCT03022435|O2|Outcome|Group B: 18-30 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
3216|NCT03022435|O1|Outcome|Group B: 18-30 yo Identical Twins (LAIV)|Participants to receive FluMist® LAIV by nasal spray.
3217|NCT03022435|E5|Reported Event|Group F: 65 - 100 yo Identical Twins (High-Dose TIV)|Participants to receive High-Dose Fluzone® standard TIV
3218|NCT03022435|E4|Reported Event|Group F: 65 - 100 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
3219|NCT03022435|E3|Reported Event|Group D: 40 - 64 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
3220|NCT03022435|E2|Reported Event|Group B: 18-30 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
3221|NCT03022435|E1|Reported Event|Group B: 18-30 yo Identical Twins (LAIV)|Participants to receive FluMist® LAIV by nasal spray.
3222|NCT03022422|B7|Baseline|Total|Total of all reporting groups
3223|NCT03022422|B6|Baseline|Group F: 65-100 yo Identical Twins (High-DoseTIV)|Individual twins will receive Fluzone® high-dose TIV: High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for Intramuscular Injection
20021|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
3228|NCT03022422|B1|Baseline|Group B: 18-30 yo Identical Twins (TIV)|"Individual twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3229|NCT03022422|P6|Participant Flow|Group F: 65-100 yo Identical Twins (High-Dose TIV)|Individual Twins will receive High-Dose Fluzone® TIV: High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for Intramuscular Injection
3230|NCT03022422|P5|Participant Flow|Group F: 65-100 yo Identical Twins (TIV)|Individual Twins will receive Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection
3231|NCT03022422|P4|Participant Flow|Group E: 40-64 yo Fraternal Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3232|NCT03022422|P3|Participant Flow|Group D: 40-64 yo Identical Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3233|NCT03022422|P2|Participant Flow|Group C: 18-30 yo Fraternal Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3234|NCT03022422|P1|Participant Flow|Group B: 18-30 yo Identical Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3235|NCT03022422|O6|Outcome|Group F: 65-100 yo Identical Twins (High-Dose TIV)|Individual Twins will receive High-Dose Fluzone® TIV: High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for Intramuscular Injection
3236|NCT03022422|O5|Outcome|Group F: 65-100 yo Identical Twins (TIV)|Individual Twins will receive Fluzone® TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection
3237|NCT03022422|O4|Outcome|Group E: 40-64 yo Fraternal Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3238|NCT03022422|O3|Outcome|Group D: 40-64 yo Identical Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3239|NCT03022422|O2|Outcome|Group C: 18-30 yo Fraternal Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3240|NCT03022422|O1|Outcome|Group B: 18-30 yo Identical Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3241|NCT03022422|O6|Outcome|Group F: 65-100 yo Identical Twins (High-DoseTIV)|Individual Twins will receive High-Dose Fluzone® TIV: High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for Intramuscular Injection
3242|NCT03022422|O5|Outcome|Group F: 65-100 yo Identical Twins (TIV)|Individual Twins will receive Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection
3243|NCT03022422|O4|Outcome|Group E: 40-64 yo Fraternal Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3244|NCT03022422|O3|Outcome|Group D: 40-64 yo Identical Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3245|NCT03022422|O2|Outcome|Group C: 18-30 yo Fraternal Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3246|NCT03022422|O1|Outcome|Group B: 18-30 yo Identical Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3247|NCT03022422|E6|Reported Event|Group F: 65-100 yo Identical Twins (High-Dose TIV)|Participants will receive High-Dose Fluzone® TIV: High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for Intramuscular Injection
3248|NCT03022422|E5|Reported Event|Group F: 65-100 yo Identical Twins (TIV)|Individual Twins will receive Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection
3249|NCT03022422|E4|Reported Event|Group E: 40-64 yo Fraternal Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3250|NCT03022422|E3|Reported Event|Group D: 40-64 yo Identical Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3251|NCT03022422|E2|Reported Event|Group C: 18-30 yo Fraternal Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3252|NCT03022422|E1|Reported Event|Group B: 18-30 yo Identical Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3253|NCT03022396|B7|Baseline|Total|Total of all reporting groups
3254|NCT03022396|B6|Baseline|Group F: Age 70 - 100 yo Twins|"Individual twins to receive Fluzone® (intramuscular) or High Dose Fluzone® (intramuscular)~High Dose Fluzone® (intramuscular): Licensed seasonal High dose trivalent inactivated influenza~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3255|NCT03022396|B5|Baseline|Group E: Age 40 - 59 yo Fraternal Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3256|NCT03022396|B4|Baseline|Group D: Age 40 - 59 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3257|NCT03022396|B3|Baseline|Group C: Age 18-30 yo Fraternal Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3258|NCT03022396|B2|Baseline|Group B: Age 18-30 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3259|NCT03022396|B1|Baseline|Group A: Age 8-17 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3355|NCT03020472|E1|Reported Event|2008-2009 FluMist LAIV (Intranasal)|"2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine~2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally"
3260|NCT03022396|P6|Participant Flow|Group F: Age 70 - 100 yo Identical Twins|"Individual Twins to receive Fluzone® (intramuscular) or High Dose Fluzone® (intramuscular)~High Dose Fluzone® (intramuscular): Licensed seasonal High dose trivalent inactivated influenza~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3261|NCT03022396|P5|Participant Flow|Group E: Age 40 - 59 yo Fraternal Twins|"Individual Twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3262|NCT03022396|P4|Participant Flow|Group D: Age 40 - 59 yo Identical Twins|"Individual Twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3263|NCT03022396|P3|Participant Flow|Group C: Age 18-30 yo Fraternal Twins|"Individual Twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3264|NCT03022396|P2|Participant Flow|Group B: Age 18-30 yo Identical Twins|"Individual Twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3265|NCT03022396|P1|Participant Flow|Group A: Age 8-17 yo Identical Twins|"Individual Twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3266|NCT03022396|O6|Outcome|Group F: Age 70 - 100 yo Twins|"Individual twins to receive Fluzone® (intramuscular) or High Dose Fluzone® (intramuscular)~High Dose Fluzone® (intramuscular): Licensed seasonal High dose trivalent inactivated influenza~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3267|NCT03022396|O5|Outcome|Group E: Age 40 - 59 yo Fraternal Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3268|NCT03022396|O4|Outcome|Group D: Age 40 - 59 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3269|NCT03022396|O3|Outcome|Group C: Age 18-30 yo Fraternal Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3270|NCT03022396|O2|Outcome|Group B: Age 18-30 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3271|NCT03022396|O1|Outcome|Group A: Age 8-17 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3272|NCT03022396|O6|Outcome|Group F: Age 70 - 100 yo Twins|"Individual twins to receive Fluzone® (intramuscular) or High Dose Fluzone® (intramuscular)~High Dose Fluzone® (intramuscular): Licensed seasonal High dose trivalent inactivated influenza~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3273|NCT03022396|O5|Outcome|Group E: Age 40 - 59 yo Fraternal Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3274|NCT03022396|O4|Outcome|Group D: Age 40 - 59 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3275|NCT03022396|O3|Outcome|Group C: Age 18-30 yo Fraternal Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3276|NCT03022396|O2|Outcome|Group B: Age 18-30 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3277|NCT03022396|O1|Outcome|Group A: Age 8-17 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3278|NCT03022396|E6|Reported Event|Group F: Age 70 - 100 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular) or High-Dose Fluzone® (intramuscular)~High-Dose Fluzone® (intramuscular): Licensed seasonal High-Dose trivalent inactivated influenza~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3279|NCT03022396|E5|Reported Event|Group E: Age 40 - 59 yo Fraternal Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3280|NCT03022396|E4|Reported Event|Group D: Age 40 - 59 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3281|NCT03022396|E3|Reported Event|Group C: Age 18-30 yo Fraternal Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3282|NCT03022396|E2|Reported Event|Group B: Age 18-30 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3283|NCT03022396|E1|Reported Event|Group A: Age 8-17 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
3284|NCT03021343|B3|Baseline|Total|Total of all reporting groups
3285|NCT03021343|B2|Baseline|No Colchicine|In this arm no active medication was administered
3286|NCT03021343|B1|Baseline|Colchicine|"Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing <70 kg or intolerant to the full dose.~Colchicine: colchicine given as per trial protocol"
3287|NCT03021343|P2|Participant Flow|No Colchicine|In this arm no active medication was administered
3288|NCT03021343|P1|Participant Flow|Colchicine|"Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing <70 kg or intolerant to the full dose.~Colchicine: colchicine given as per trial protocol"
3289|NCT03021343|O2|Outcome|No Colchicine|In this arm no active medication was administered
3290|NCT03021343|O1|Outcome|Colchicine|"Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing <70 kg or intolerant to the full dose.~Colchicine: colchicine given as per trial protocol"
3291|NCT03021343|O2|Outcome|No Colchicine|In this arm no active medication was administered
8326|NCT02743780|E5|Reported Event|Placebo Part 1|1 drop in the study eye
3292|NCT03021343|O1|Outcome|Colchicine|"Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing <70 kg or intolerant to the full dose.~Colchicine: colchicine given as per trial protocol"
3293|NCT03021343|E2|Reported Event|No Colchicine|In this arm no active medication was administered
3294|NCT03021343|E1|Reported Event|Colchicine|"Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing <70 kg or intolerant to the full dose.~Colchicine: colchicine given as per trial protocol"
3295|NCT03021304|B1|Baseline|Mepolizumab Liquid Safety Syringe|The participants (or their caregivers) self-administered, 100 mg mepolizumab liquid drug product subcutaneously every 4-weeks (3-doses) as a single injection using safety syringe, in the thigh, abdomen or upper arm (caregiver only), for 12-weeks.
3296|NCT03021304|P1|Participant Flow|Mepolizumab Liquid Safety Syringe|The participants (or their caregivers) self-administered, 100 milligram (mg) mepolizumab liquid drug product subcutaneously every 4-weeks (3-doses) as a single injection using safety syringe, in the thigh, abdomen or upper arm (caregiver only), for 12-weeks.
3297|NCT03021304|O1|Outcome|Mepolizumab Liquid Safety Syringe|The participants (or their caregivers) self-administered, 100 mg mepolizumab liquid drug product subcutaneously every 4 weeks (3-doses) as a single injection using safety syringe, in the thigh, abdomen or upper arm (caregiver only), for 12 weeks.
3298|NCT03021304|O1|Outcome|Mepolizumab Liquid Safety Syringe|The participants (or their caregivers) self-administered, 100 mg mepolizumab liquid drug product subcutaneously every 4 weeks (3-doses) as a single injection using safety syringe, in the thigh, abdomen or upper arm (caregiver only), for 12 weeks.
3299|NCT03021304|E1|Reported Event|Mepolizumab Liquid Safety Syringe|The participants (or their caregivers) self-administered, 100 mg mepolizumab liquid drug product subcutaneously every 4-weeks (3-doses) as a single injection using safety syringe, in the thigh, abdomen or upper arm (caregiver only), for 12-weeks.
3300|NCT03020576|B3|Baseline|Total|Total of all reporting groups
3301|NCT03020576|B2|Baseline|Robotic Group|The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.
3302|NCT03020576|B1|Baseline|Conventional Group|The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.
3303|NCT03020576|P2|Participant Flow|Robotic Group|The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.
3304|NCT03020576|P1|Participant Flow|Conventional Group|The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.
3305|NCT03020576|O2|Outcome|Robotic Group|The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.
3306|NCT03020576|O1|Outcome|Conventional Group|The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.
3307|NCT03020576|O2|Outcome|Robotic Group|The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.
3308|NCT03020576|O1|Outcome|Conventional Group|The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.
3309|NCT03020576|O2|Outcome|Robotic Group|The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.
3310|NCT03020576|O1|Outcome|Conventional Group|The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.
3311|NCT03020576|O2|Outcome|Robotic Group|The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.
3736|NCT02967354|O4|Outcome|Normal Weight, Treated With Oral Antidiabetic Drugs|BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs
3312|NCT03020576|O1|Outcome|Conventional Group|The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.
3313|NCT03020576|O2|Outcome|Robotic Group|The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.
3314|NCT03020576|O1|Outcome|Conventional Group|The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.
3315|NCT03020576|O2|Outcome|Robotic Group|The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.
3316|NCT03020576|O1|Outcome|Conventional Group|The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.
3317|NCT03020576|O2|Outcome|Robotic Group|The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.
3318|NCT03020576|O1|Outcome|Conventional Group|The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.
3319|NCT03020576|O2|Outcome|Robotic Group|The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.
3320|NCT03020576|O1|Outcome|Conventional Group|The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.
3321|NCT03020576|E2|Reported Event|Robotic Group|The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.
3322|NCT03020576|E1|Reported Event|Conventional Group|The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.
3323|NCT03020537|B3|Baseline|Total|Total of all reporting groups
3324|NCT03020537|B2|Baseline|Group B: 18-30 Years Old|"Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
3325|NCT03020537|B1|Baseline|Group A: 1 - 2 Years Old|"Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
3326|NCT03020537|P2|Participant Flow|Group B: 18-30 Years Old|"Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
3327|NCT03020537|P1|Participant Flow|Group A: 1 - 2 Years Old|"Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
3328|NCT03020537|O2|Outcome|Group B: 18-30 Years Old|"Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
3329|NCT03020537|O1|Outcome|Group A: 1 - 2 Years Old|"Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
3330|NCT03020537|O2|Outcome|Group B: 18-30 Years Old|"Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
3546|NCT02988219|B2|Baseline|Combined General/Epidural (G/E)|General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
3331|NCT03020537|O1|Outcome|Group A: 1 - 2 Years Old|"Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
3332|NCT03020537|E2|Reported Event|Group B: 18-30 Years Old|"Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
3333|NCT03020537|E1|Reported Event|Group A: 1 - 2 Years Old|"Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
3334|NCT03020498|B4|Baseline|Total|Total of all reporting groups
3335|NCT03020498|B3|Baseline|Group C: 70-100 yo Non-twin|"Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3336|NCT03020498|B2|Baseline|Group B: 8-30 yo Non-twin|"Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
3337|NCT03020498|B1|Baseline|Group A: 8-17 yo Identical Twins|"Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
3338|NCT03020498|P3|Participant Flow|Group C: 70-100 yo Non-twin|"Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3339|NCT03020498|P2|Participant Flow|Group B: 8-30 yo Non-twin|"Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
3340|NCT03020498|P1|Participant Flow|Group A: 8-17 yo Identical Twins|"Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
3341|NCT03020498|O3|Outcome|Group C: 70-100 yo Non-twin|"Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3342|NCT03020498|O2|Outcome|Group B: 8-30 yo Non-twin|"Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
3343|NCT03020498|O1|Outcome|Group A: 8-17 yo Identical Twins|"Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
3344|NCT03020498|O3|Outcome|Group C: 70-100 yo Non-twin|"Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3345|NCT03020498|O2|Outcome|Group B: 8-30 yo Non-twin|"Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
3346|NCT03020498|O1|Outcome|Group A: 8-17 yo Identical Twins|"Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
3347|NCT03020498|E3|Reported Event|Group C: 70-100 yo Non-twin|"Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection"
3348|NCT03020498|E2|Reported Event|Group B: 8-30 yo Non-twin|"Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
3349|NCT03020498|E1|Reported Event|Group A: 8-17 yo Identical Twins|"Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
3350|NCT03020472|B1|Baseline|2008-2009 FluMist LAIV (Intranasal)|"2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine~2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally"
3351|NCT03020472|P1|Participant Flow|2008-2009 FluMist LAIV (Intranasal)|"Seasonal live, attenuated influenza vaccine (LAIV)~2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally"
3352|NCT03020472|O1|Outcome|2008-2009 FluMist LAIV (Intranasal)|"2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine~2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally"
3353|NCT03020472|O1|Outcome|2008-2009 FluMist LAIV (Intranasal)|"2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine~2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally"
3354|NCT03020472|O1|Outcome|2008-2009 FluMist LAIV (Intranasal)|"2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine~2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally"
8327|NCT02743780|E4|Reported Event|MGV354 0.3% Part 1|1 drop in the study eye
3356|NCT03020004|B1|Baseline|Danoprevir,Ritonavir, Peg-IFN,RBV|"Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg) for 12 weeks.~Danoprevir: Danoprevir (DNV) 100mg tablet administered orally twice daily~Ritonavir: Ritonavir 100mg tablet administered orally twice daily~peginterferon alfa-2a: PegIFN subcutaneous injection at 180 mcg weekly~Ribavirin (RBV): Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)"
3357|NCT03020004|P1|Participant Flow|Danoprevir,Ritonavir, Peg-IFN,RBV|"Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg) for 12 weeks.~Danoprevir: Danoprevir (DNV) 100mg tablet administered orally twice daily~Ritonavir: Ritonavir 100mg tablet administered orally twice daily~peginterferon alfa-2a: PegIFN subcutaneous injection at 180 mcg weekly~Ribavirin (RBV): Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)"
3358|NCT03020004|O1|Outcome|Danoprevir,Ritonavir, Peg-IFN,RBV|"Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg) for 12 weeks.~Danoprevir: Danoprevir (DNV) 100mg tablet administered orally twice daily~Ritonavir: Ritonavir 100mg tablet administered orally twice daily~peginterferon alfa-2a: PegIFN subcutaneous injection at 180 mcg weekly~Ribavirin (RBV): Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)"
3359|NCT03020004|E1|Reported Event|Danoprevir,Ritonavir, Peg-IFN,RBV|"Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg) for 12 weeks.~Danoprevir: Danoprevir (DNV) 100mg tablet administered orally twice daily~Ritonavir: Ritonavir 100mg tablet administered orally twice daily~peginterferon alfa-2a: PegIFN subcutaneous injection at 180 mcg weekly~Ribavirin (RBV): Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)"
3360|NCT03019783|B3|Baseline|Total|Total of all reporting groups
3361|NCT03019783|B2|Baseline|Atazanavir Switch|"These subjects are switched to an atazanavir-based regimen.~Atazanavir: The active group will switch from a non-atazanavir regimen to an atazanavir-based regimen."
3362|NCT03019783|B1|Baseline|Remains on Baseline HIV Regimen|"Subjects are enrolled and either kept on their baseline regimen. This is being designated the placebo comparator.~Placebo: The control group will stay on their baseline regimen"
3363|NCT03019783|P2|Participant Flow|Atazanavir Switch|"These subjects are switched to an atazanavir-based regimen.~Atazanavir: The active group will switch from a non-atazanavir regimen to an atazanavir-based regimen."
3364|NCT03019783|P1|Participant Flow|Remains on Baseline HIV Regimen|"Subjects are enrolled and either kept on their baseline regimen. This is being designated the placebo comparator.~Placebo: The control group will stay on their baseline regimen"
3365|NCT03019783|O2|Outcome|Atazanavir Switch|"These subjects are switched to an atazanavir-based regimen.~Atazanavir: The active group will switch from a non-atazanavir regimen to an atazanavir-based regimen."
3366|NCT03019783|O1|Outcome|Remains on Baseline HIV Regimen|"Subjects are enrolled and either kept on their baseline regimen. This is being designated the placebo comparator.~Placebo: The control group will stay on their baseline regimen"
3367|NCT03019783|O2|Outcome|Atazanavir Switch|"These subjects are switched to an atazanavir-based regimen.~Atazanavir: The active group will switch from a non-atazanavir regimen to an atazanavir-based regimen."
3368|NCT03019783|O1|Outcome|Remains on Baseline HIV Regimen|"Subjects are enrolled and either kept on their baseline regimen. This is being designated the placebo comparator.~Placebo: The control group will stay on their baseline regimen"
3369|NCT03019783|E2|Reported Event|Atazanavir Switch|"These subjects are switched to an atazanavir-based regimen.~Atazanavir: The active group will switch from a non-atazanavir regimen to an atazanavir-based regimen."
3370|NCT03019783|E1|Reported Event|Remains on Baseline HIV Regimen|"Subjects are enrolled and either kept on their baseline regimen. This is being designated the placebo comparator.~Placebo: The control group will stay on their baseline regimen"
3371|NCT03018106|B3|Baseline|Total|Total of all reporting groups
3372|NCT03018106|B2|Baseline|Estrogen|Women randomized to this arm were to receive 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
3373|NCT03018106|B1|Baseline|Ospemifene|Women randomized to this arm were to receive 60mg oral ospemifene, taken daily, for 12 weeks
3374|NCT03018106|P2|Participant Flow|Estrogen|Women randomized to this arm were to receive 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
3375|NCT03018106|P1|Participant Flow|Ospemifene|Women randomized to this arm were to receive 60mg oral ospemifene, taken daily, for 12 weeks
3376|NCT03018106|O1|Outcome|Estrogen|Women randomized to this arm received 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
3377|NCT03018106|O1|Outcome|Estrogen|Women randomized to this arm received 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
3378|NCT03018106|O1|Outcome|Estrogen|Women randomized to this arm received 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
3379|NCT03018106|O1|Outcome|Estrogen|Women randomized to this arm received 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
3380|NCT03018106|O1|Outcome|Estrogen|Women randomized to this arm received 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
3381|NCT03018106|E1|Reported Event|Estrogen|Women randomized to this arm received 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
3382|NCT03017612|B1|Baseline|Single Arm Study|"Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects~Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision."
3447|NCT03005041|O1|Outcome|Experimental Oral Rinse|Participants were supervised to rinse their mouth with 15 mL of the experimental oral rinse/mouth wash swishing for 30 seconds. Participants then spat out product. No rinsing with water immediately after experimental oral rinse/mouth wash use was permitted.
3383|NCT03017612|P1|Participant Flow|Single Arm Study|"Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects~Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision."
3384|NCT03017612|O1|Outcome|Single Arm Study|"Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects~Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision."
3385|NCT03017612|O1|Outcome|Single Arm Study|"Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects~Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision."
3386|NCT03017612|O1|Outcome|Single Arm Study|"Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects~Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision."
3387|NCT03017612|O1|Outcome|Single Arm Study|"Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects~Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision."
3388|NCT03017612|O1|Outcome|Single Arm Study|"Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects~Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision."
3389|NCT03017612|E1|Reported Event|Single Arm Study|"Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects~Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision."
3390|NCT03016078|B1|Baseline|Mepilex Border Post-Op Ag Dressing|A soft silicone foam dressing that absorbs wound exudate maintains a moist wound healing environment and has antimicrobial properties
3391|NCT03016078|P1|Participant Flow|Mepilex Border Post-Op Ag Dressing|A soft silicone foam dressing that absorbs wound exudate maintains a moist wound healing environment and has antimicrobial properties
3392|NCT03016078|O1|Outcome|The Study Group|Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
3393|NCT03016078|O1|Outcome|The Study Group|Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
3394|NCT03016078|O1|Outcome|The Study Group|Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
3395|NCT03016078|O1|Outcome|The Study Group|Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
3396|NCT03016078|O1|Outcome|The Study Group|Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
3397|NCT03016078|O1|Outcome|The Study Group|Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
3398|NCT03016078|O1|Outcome|The Study Group|Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
3399|NCT03016078|O1|Outcome|The Study Group|Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
3400|NCT03016078|E1|Reported Event|The Study Group|Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
3401|NCT03011099|B3|Baseline|Total|Total of all reporting groups
3402|NCT03011099|B2|Baseline|Conventional Physical Therapy|During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
3403|NCT03011099|B1|Baseline|Robotic Exoskeleton Training|During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.
20022|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
3404|NCT03011099|P2|Participant Flow|Conventional Physical Therapy|During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
3405|NCT03011099|P1|Participant Flow|Robotic Exoskeleton Training|During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.
3406|NCT03011099|O2|Outcome|Conventional Physical Therapy|Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training
3407|NCT03011099|O1|Outcome|Robotic Exoskeleton Training|Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes
3408|NCT03011099|O2|Outcome|Conventional Physical Therapy|Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training
3409|NCT03011099|O1|Outcome|Robotic Exoskeleton Training|Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes
3410|NCT03011099|O2|Outcome|Conventional Physical Therapy|Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training
3411|NCT03011099|O1|Outcome|Robotic Exoskeleton Training|Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes
3412|NCT03011099|O2|Outcome|Conventional Physical Therapy|Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training
3413|NCT03011099|O1|Outcome|Robotic Exoskeleton Training|Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes
3414|NCT03011099|O2|Outcome|Conventional Physical Therapy|Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training
3415|NCT03011099|O1|Outcome|Robotic Exoskeleton Training|Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes
3416|NCT03011099|O2|Outcome|Conventional Physical Therapy|Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training
3417|NCT03011099|O1|Outcome|Robotic Exoskeleton Training|Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes
3418|NCT03011099|O2|Outcome|Conventional Physical Therapy|Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training
3419|NCT03011099|O1|Outcome|Robotic Exoskeleton Training|Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes
3420|NCT03011099|O2|Outcome|Conventional Physical Therapy|Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training
3448|NCT03005041|E2|Reported Event|Mineral Water|Participants were supervised to rinse their mouth with 15 mL of the mineral water swishing for 30 seconds. Participants then spat out the water.
3421|NCT03011099|O1|Outcome|Robotic Exoskeleton Training|Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes
3422|NCT03011099|O2|Outcome|Conventional Physical Therapy|Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training
3423|NCT03011099|O1|Outcome|Robotic Exoskeleton Training|Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes
3424|NCT03011099|O2|Outcome|Conventional Physical Therapy|During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
3425|NCT03011099|O1|Outcome|Robotic Exoskeleton Training|During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.
3426|NCT03011099|E2|Reported Event|Conventional Physical Therapy|Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training
3427|NCT03011099|E1|Reported Event|Robotic Exoskeleton Training|Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes
3428|NCT03010800|B3|Baseline|Total|Total of all reporting groups
3429|NCT03010800|B2|Baseline|Without Yoni.Fit First|Without the Yoni.Fit first, then with the Yoni.Fit.
3430|NCT03010800|B1|Baseline|With Yoni.Fit First|With the Yoni.Fit first, then without the Yoni.Fit.
3431|NCT03010800|P2|Participant Flow|Without Yoni.Fit First|Without Yoni.Fit first, then with Yoni.Fit.
3432|NCT03010800|P1|Participant Flow|With Yoni.Fit First|Yoni.Fit first, then without the Yoni.Fit.
3433|NCT03010800|O2|Outcome|Without Yoni.Fit|Pad weights without Yoni.Fit.
3434|NCT03010800|O1|Outcome|With Yoni.Fit|Pad weights for with the Yoni.Fit
3435|NCT03010800|E2|Reported Event|Without Yoni.Fit|Those subjects assigned to use the pad first.
3436|NCT03010800|E1|Reported Event|With Yoni.Fit|Those subjects assigned to use the Yoni.Fit first
3437|NCT03005041|B1|Baseline|Overall Study Participants|All randomized participants who received both the treatments experimental oral rinse/mouthwash and mineral water were included in the baseline assessment.
3438|NCT03005041|P2|Participant Flow|Mineral Water/Experimental Oral Rinse|Participants were supervised to rinse their mouth with 15 mL of the mineral water swishing followed by with 15mL of experimental oral rinse/mouth wash swishing in period 1 and period 2 respectively. Participants then spat out products after rinsing for 30 seconds. No rinsing with water immediately after experimental oral rinse/mouth wash use was permitted. Each period was separated by a washout period of minimum 24 hours to maximum 7 days.
3439|NCT03005041|P1|Participant Flow|Experimental Oral Rinse/Mineral Water|Participants were supervised to rinse their mouth with 15 milliliter (mL) of the experimental oral rinse/mouth wash swishing followed by with 15mL of mineral water swishing in period 1 and period 2 respectively. Participants then spat out products after rinsing for 30 seconds. No rinsing with water immediately after experimental oral rinse/mouth wash use was permitted. Each period was separated by a washout period of minimum 24 hours to maximum 7 days.
3440|NCT03005041|O2|Outcome|Mineral Water|Participants were supervised to rinse their mouth with 15 mL of the mineral water swishing for 30 seconds. Participants then spat out the water.
3441|NCT03005041|O1|Outcome|Experimental Oral Rinse|Participants were supervised to rinse their mouth with 15 mL of the experimental oral rinse/mouth wash swishing for 30 seconds. Participants then spat out product. No rinsing with water immediately after experimental oral rinse/mouth wash use was permitted.
3442|NCT03005041|O2|Outcome|Mineral Water|Participants were supervised to rinse their mouth with 15 mL of the mineral water swishing for 30 seconds. Participants then spat out the water.
3443|NCT03005041|O1|Outcome|Experimental Oral Rinse|Participants were supervised to rinse their mouth with 15 mL of the experimental oral rinse/mouth wash swishing for 30 seconds. Participants then spat out product. No rinsing with water immediately after experimental oral rinse/mouth wash use was permitted.
3444|NCT03005041|O2|Outcome|Mineral Water|Participants were supervised to rinse their mouth with 15 mL of the mineral water swishing for 30 seconds. Participants then spat out the water.
3445|NCT03005041|O1|Outcome|Experimental Oral Rinse|Participants were supervised to rinse their mouth with 15 mL of the experimental oral rinse/mouth wash swishing for 30 seconds. Participants then spat out product. No rinsing with water immediately after experimental oral rinse/mouth wash use was permitted.
3446|NCT03005041|O2|Outcome|Mineral Water|Participants were supervised to rinse their mouth with 15 mL of the mineral water swishing for 30 seconds. Participants then spat out the water.
20023|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
3449|NCT03005041|E1|Reported Event|Experimental Oral Rinse|Participants were supervised to rinse their mouth with 15 mL of the experimental oral rinse/mouth wash swishing for 30 seconds. Participants then spat out product. No rinsing with water immediately after experimental mouth wash use was permitted.
3450|NCT03002454|B1|Baseline|99mTc MDP Injection:Neutron-bombardment|"Oncologic indication for which a bone scan would normally be indicated. Participant having recently had a bone scan using Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from fission-sourced 99Mo.~99mTc MDP Injection:neutron-bombardment: Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo."
3451|NCT03002454|P1|Participant Flow|99mTc MDP Injection:Neutron-bombardment|"Oncologic indication for which a bone scan would normally be indicated. All 4 participants initially had a bone scan using Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from fission-sourced 99Mo.~3-28 days later all participants had a second bone scan using Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo."
3452|NCT03002454|O1|Outcome|99mTc MDP Injection:Neutron-bombardment|"Oncologic indication for which a bone scan would normally be indicated. Participant having recently had a bone scan using Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from fission-sourced 99Mo.~99mTc MDP Injection:neutron-bombardment: Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo."
3453|NCT03002454|E2|Reported Event|99mTc MDP Injection:Neutron-bombardment|"Oncologic indication for which a bone scan would normally be indicated. Participant having recently had a bone scan using Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from fission-sourced 99Mo.~99mTc MDP Injection:neutron-bombardment: Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo."
3454|NCT03002454|E1|Reported Event|99mTc MDP Injection:Fission|"Oncologic indication for which a bone scan would normally be indicated.~99mTc MDP Injection:fission: Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from fission-sourced 99Mo."
3455|NCT03001674|B3|Baseline|Total|Total of all reporting groups
3456|NCT03001674|B2|Baseline|Control|Conductance catheterization: CD Leycom Conductance Catheter
3457|NCT03001674|B1|Baseline|IABP Recipient|Conductance catheterization: CD Leycom Conductance Catheter
3458|NCT03001674|P2|Participant Flow|Control Group|Control subjects undergoing left heart catheterization with an LV ejection fraction > 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled.
3459|NCT03001674|P1|Participant Flow|IABP Recipient|"Prospective, double-arm, pilot study.~Conductance catheterization: CD Leycom Conductance Catheter"
3460|NCT03001674|O2|Outcome|Control|"Control subjects undergoing left heart catheterization with an LV ejection fraction > 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled.~Conductance catheterization: CD Leycom Conductance Catheter"
3461|NCT03001674|O1|Outcome|IABP Recipient|"Referred for clinically indicated right heart catheterization with intervention of IABP placement prior to LVAD surgery.~Conductance catheterization: CD Leycom Conductance Catheter"
3462|NCT03001674|E2|Reported Event|Control Group|Control subjects undergoing left heart catheterization with an LV ejection fraction > 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled.
3463|NCT03001674|E1|Reported Event|IABP Recipient|"Prospective, double-arm, pilot study.~Conductance catheterization: CD Leycom Conductance Catheter"
3464|NCT03001258|B4|Baseline|Total|Total of all reporting groups
3465|NCT03001258|B3|Baseline|SS (Shashthya Shebika)|"SS: Community health workers of Brac. A two day presbyopia screening training were provided.~In this arm, the SS, undertook the screening of potential presbyopia cases. A total of 27 SS organized 25 eye camps in eight days in two upazilas.~Presbyopia screening training: The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity"
3466|NCT03001258|B2|Baseline|USS (Upgraded Shashthya Shebika)|"USS (Upgraded Shashthya Shebika): A new cadre of community health workers of Brac. A two day presbyopia screening training were provided.~20 USSs were assigned in two upazillas to run the two camp-day i.e. screening patients and selling glasses during the camps.~The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity."
3467|NCT03001258|B1|Baseline|PO (Program Organizers)|"PO (program organizers): Employed by Brac as field level organizers. A two day presbyopia screening training were provided. The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity.~A total of 40 eye camps were held in two sub districts by eight POs."
3504|NCT02990910|O2|Outcome|Conventional Opioid Analgesia|"Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.~conventional opioid analgesia: (b) all received 25μg/kg morphine"
3547|NCT02988219|B1|Baseline|General Anesthesia (G)|General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
3468|NCT03001258|P3|Participant Flow|SS (Shashthya Shebika)|"SS: Community health workers of Brac. A two day presbyopia screening training were provided.~In this arm, the SS, undertook the screening of potential presbyopia cases. A total of 27 SS organized 25 eye camps in eight days in two upazilas.~Presbyopia screening training: The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity"
3469|NCT03001258|P2|Participant Flow|USS (Upgraded Shashthya Shebika)|"USS (Upgraded Shashthya Shebika): A new caddre of community health workers of Brac. A two day presbyopia screening training were provided.~In this arm, 20 USSs were assigned in two upazillas to run the two camp-day i.e. screening patients and selling glasses during the total 40 eye camps.~Presbyopia screening training: The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as"
3470|NCT03001258|P1|Participant Flow|PO (Program Organizers)|"PO (program organizers): Employed by Brac as field level organizers. A two day presbyopia screening training were provided.~A total of eight POs organized eye camps in two sub districts. POs were responsible for identifying the presbyopia patients through screening and SS assisted in organizing and mobilizing the community people for the eye camps, and glass sale (on the spot). Four camps were organized per day for five days by four POs in each sub-district. A total of 40 eye camps were held in two sub districts by eight POs.~Presbyopia screening training: The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and managemen"
3471|NCT03001258|O3|Outcome|SS (Shashthya Shebika)|"SS: Community health workers of Brac. A two day presbyopia screening training were provided.~In this arm, the SS, undertook the screening of potential presbyopia cases. A total of 27 SS organized 25 eye camps in eight days in two upazilas.~Presbyopia screening training: The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity"
3472|NCT03001258|O2|Outcome|USS (Upgraded Shashthya Shebika)|"USS (Upgraded Shashthya Shebika): A new caddre of community health workers of Brac. A two day presbyopia screening training were provided.~20 USSs were assigned in two upazillas to run the two camp-day i.e. screening patients and selling glasses during the eye camps.~The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity"
3473|NCT03001258|O1|Outcome|PO (Program Organizers)|PO (program organizers): Employed by Brac as field level organizers. A two day presbyopia screening training were provided. The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity. A total of 40 eye camps were held in two sub districts by eight POs.
3474|NCT03001258|E3|Reported Event|SS (Shashthya Shebika)|"SS: Community health workers of Brac. A two day presbyopia screening training were provided.~In this arm, the SS, undertook the screening of potential presbyopia cases. A total of 27 SS organized 25 eye camps in eight days in two upazilas.~Presbyopia screening training: The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity"
3505|NCT02990910|O1|Outcome|Individualized Opioid Analgesia|"One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.~personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine."
3506|NCT02990910|O2|Outcome|Conventional Opioid Analgesia|"Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.~conventional opioid analgesia: (b) all received 25μg/kg morphine"
3475|NCT03001258|E2|Reported Event|USS (Upgraded Shashthya Shebika)|"USS (Upgraded Shashthya Shebika): A new cadre of community health workers of Brac. A two day presbyopia screening training were provided.~20 USSs were assigned in two upazillas to run the two camp-day i.e. screening patients and selling glasses during the eye camps.~The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity"
3476|NCT03001258|E1|Reported Event|PO (Program Organizers)|PO (program organizers): Employed by Brac as field level organizers. A two day presbyopia screening training were provided. The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity A total of 40 eye camps were held in two sub districts by eight POs.
3477|NCT03000088|B3|Baseline|Total|Total of all reporting groups
3478|NCT03000088|B2|Baseline|90°Angle Group|"intubate using McGrath Videolaryngoscope with 90° angled stylet~intubate with 60° angled stylet"
3479|NCT03000088|B1|Baseline|60° Angle Group|"intubate using McGrath Videolaryngoscope with 60° angled stylet~intubate with 60° angled stylet"
3480|NCT03000088|P2|Participant Flow|90°Angle Group|"intubate using McGrath Videolaryngoscope with 90° angled stylet~intubate with 60° angled stylet"
3481|NCT03000088|P1|Participant Flow|60° Angle Group|"intubate using McGrath Videolaryngoscope with 60° angled stylet~intubate with 60° angled stylet"
3482|NCT03000088|O2|Outcome|60° Angle Group|"intubate using McGrath Videolaryngoscope with 60° angled stylet~intubate with 60° angled stylet"
3483|NCT03000088|O1|Outcome|90°Angle Group|"intubate using McGrath Videolaryngoscope with 90° angled stylet~intubate with 60° angled stylet"
3484|NCT03000088|E2|Reported Event|90°Angle Group|"intubate using McGrath Videolaryngoscope with 90° angled stylet~intubate with 60° angled stylet"
3485|NCT03000088|E1|Reported Event|60° Angle Group|"intubate using McGrath Videolaryngoscope with 60° angled stylet~intubate with 60° angled stylet"
3486|NCT02997904|B3|Baseline|Total|Total of all reporting groups
3487|NCT02997904|B2|Baseline|Sham Lice and Egg Removal Kit|"20% glycerin combing solution, comb and instructions for use in a kit: kit used once and combed out for 1 hour~Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb"
3488|NCT02997904|B1|Baseline|Resultz Lice and Egg Removal Kit|"Resultz combing solution, head lice comb and instructions for use in a kit: kit used once and combed out for 1 hour~Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb"
3489|NCT02997904|P2|Participant Flow|Sham Lice and Egg Removal Kit|"20% glycerin combing solution, comb and instructions for use in a kit: kit used once and combed out for 1 hour~Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb"
3490|NCT02997904|P1|Participant Flow|Resultz Lice and Egg Removal Kit|"Resultz combing solution, head lice comb and instructions for use in a kit: kit used once and combed out for 1 hour~Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb"
3491|NCT02997904|O4|Outcome|Number of Eggs Removed by Control|Total number of eggs removed after one hour of combing by control, analyzed separately
3492|NCT02997904|O3|Outcome|Number of Eggs Removed by Resultz|Total number of eggs removed after one hour of combing, analyzed separately
3493|NCT02997904|O2|Outcome|Number of Lice Removed by Control|Total number of lice removed after one hour of combing by control; analyzed separately
3494|NCT02997904|O1|Outcome|Number or Lice Removed by Resultz|Total number of lice removed after one hour of combing with Resultz; analyzed separately
3495|NCT02997904|O2|Outcome|Sham Lice and Egg Elimination Kit|"20% glycerin combing solution, comb and instructions for use in a kit: kit used once and combed out for 1 hour~Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb"
3496|NCT02997904|O1|Outcome|Resultz Lice and Egg Elimination Kit|"Resultz combing solution, head lice comb and instructions for use in a kit: kit used once and combed out for 1 hour~Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb"
3497|NCT02997904|E2|Reported Event|Sham Lice and Egg Removal Kit|"20% glycerin combing solution, comb and instructions for use in a kit: kit used once and combed out for 1 hour~Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb"
3498|NCT02997904|E1|Reported Event|Resultz Lice and Egg Removal Kit|"Resultz combing solution, head lice comb and instructions for use in a kit: kit used once and combed out for 1 hour~Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb"
3499|NCT02990910|B3|Baseline|Total|Total of all reporting groups
3500|NCT02990910|B2|Baseline|Conventional Opioid Analgesia|"Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.~conventional opioid analgesia: (b) all received 25μg/kg morphine"
3501|NCT02990910|B1|Baseline|Individualized Opioid Analgesia|"One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.~personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine."
3502|NCT02990910|P2|Participant Flow|Conventional Opioid Analgesia|"Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.~conventional opioid analgesia: (b) all received 25μg/kg morphine"
3503|NCT02990910|P1|Participant Flow|Individualized Opioid Analgesia|"One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.~personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine."
20024|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
3507|NCT02990910|O1|Outcome|Personalized Opioid Analgesia|"One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.~personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine."
3508|NCT02990910|E2|Reported Event|Conventional Opioid Analgesia|"Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.~conventional opioid analgesia: (b) all received 25μg/kg morphine"
3509|NCT02990910|E1|Reported Event|Individualized Opioid Analgesia|"One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.~personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine."
3510|NCT02988882|B3|Baseline|Total|Total of all reporting groups
3511|NCT02988882|B2|Baseline|Placebo Vehicle|PV (placebo drug delivery vehicle)
3512|NCT02988882|B1|Baseline|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
3513|NCT02988882|P2|Participant Flow|Placebo Vehicle|PV (placebo drug delivery vehicle)
3514|NCT02988882|P1|Participant Flow|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
3515|NCT02988882|O2|Outcome|Placebo Vehicle|PV (placebo drug delivery vehicle)
3516|NCT02988882|O1|Outcome|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
3517|NCT02988882|O2|Outcome|Placebo Vehicle|PV (placebo drug delivery vehicle)
3518|NCT02988882|O1|Outcome|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
3519|NCT02988882|O2|Outcome|Placebo Vehicle|PV (placebo drug delivery vehicle)
3520|NCT02988882|O1|Outcome|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
3521|NCT02988882|E2|Reported Event|Placebo Vehicle|PV (placebo drug delivery vehicle)
3522|NCT02988882|E1|Reported Event|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
3523|NCT02988622|B1|Baseline|Scar is Treated With Fraxel Laser and CO2 Laser|"Fraxel Laser: One half of the scar is treated with Fraxel Laser~CO2 Laser: One half of the scar is treated with CO2 Laser."
3524|NCT02988622|P1|Participant Flow|Scar is Treated With Fraxel Laser and CO2 Laser|"Each patient received treatment with both lasers to separate halves of their scar.~Fraxel Laser: One half of the scar is treated with Fraxel Laser~CO2 Laser: One half of the scar is treated with CO2 Laser."
3525|NCT02988622|O2|Outcome|Scar Treated With CO2 Laser|"Each patient received treatment with both lasers to separate halves of their scar.~Fraxel Laser: One half of the scar is treated with CO2 Laser"
3526|NCT02988622|O1|Outcome|Scar is Treated With Fraxel Laser|"Each patient received treatment with both lasers to separate halves of their scar.~Fraxel Laser: One half of the scar is treated with Fraxel Laser"
3527|NCT02988622|O2|Outcome|Scar Treated With CO2 Laser|"Each patient received treatment with both lasers to separate halves of their scar.~Fraxel Laser: One half of the scar is treated with CO2 Laser"
3528|NCT02988622|O1|Outcome|Scar is Treated With Fraxel Laser|"Each patient received treatment with both lasers to separate halves of their scar.~Fraxel Laser: One half of the scar is treated with Fraxel Laser"
3529|NCT02988622|O2|Outcome|Scar Treated With CO2 Laser|"Each patient received treatment with both lasers to separate halves of their scar.~Fraxel Laser: One half of the scar is treated with CO2 Laser"
3530|NCT02988622|O1|Outcome|Scar is Treated With Fraxel Laser|"Each patient received treatment with both lasers to separate halves of their scar.~Fraxel Laser: One half of the scar is treated with Fraxel Laser"
3531|NCT02988622|O2|Outcome|Scar Treated With CO2 Laser|"Each patient received treatment with both lasers to separate halves of their scar.~Fraxel Laser: One half of the scar is treated with CO2 Laser"
3532|NCT02988622|O1|Outcome|Scar is Treated With Fraxel Laser|"Each patient received treatment with both lasers to separate halves of their scar.~Fraxel Laser: One half of the scar is treated with Fraxel Laser"
3533|NCT02988622|O2|Outcome|Scar Treated With CO2 Laser|"Each patient received treatment with both lasers to separate halves of their scar.~Fraxel Laser: One half of the scar is treated with CO2 Laser"
3534|NCT02988622|O1|Outcome|Scar is Treated With Fraxel Laser|"Each patient received treatment with both lasers to separate halves of their scar.~Fraxel Laser: One half of the scar is treated with Fraxel Laser"
3535|NCT02988622|O2|Outcome|Scar Treated With CO2 Laser|"Each patient received treatment with both lasers to separate halves of their scar.~Fraxel Laser: One half of the scar is treated with CO2 Laser"
3536|NCT02988622|O1|Outcome|Scar is Treated With Fraxel Laser|"Each patient received treatment with both lasers to separate halves of their scar.~Fraxel Laser: One half of the scar is treated with Fraxel Laser"
3537|NCT02988622|O2|Outcome|Scar Treated With CO2 Laser|"Each patient received treatment with both lasers to separate halves of their scar.~Fraxel Laser: One half of the scar is treated with CO2 Laser"
3538|NCT02988622|O1|Outcome|Scar is Treated With Fraxel Laser|"Each patient received treatment with both lasers to separate halves of their scar.~Fraxel Laser: One half of the scar is treated with Fraxel Laser"
3539|NCT02988622|O2|Outcome|Scar Treated With CO2 Laser|"Each patient received treatment with both lasers to separate halves of their scar.~Fraxel Laser: One half of the scar is treated with CO2 Laser"
3540|NCT02988622|O1|Outcome|Scar is Treated With Fraxel Laser|"Each patient received treatment with both lasers to separate halves of their scar.~Fraxel Laser: One half of the scar is treated with Fraxel Laser"
3541|NCT02988622|O2|Outcome|Scar Treated With CO2 Laser|"Each patient received treatment with both lasers to separate halves of their scar.~Fraxel Laser: One half of the scar is treated with CO2 Laser"
3542|NCT02988622|O1|Outcome|Scar is Treated With Fraxel Laser|"Each patient received treatment with both lasers to separate halves of their scar.~Fraxel Laser: One half of the scar is treated with Fraxel Laser"
3543|NCT02988622|E2|Reported Event|Scar Treated With CO2 Laser|"Each patient received treatment with both lasers to separate halves of their scar.~Fraxel Laser: One half of the scar is treated with CO2 Laser"
3544|NCT02988622|E1|Reported Event|Scar is Treated With Fraxel Laser|"Each patient received treatment with both lasers to separate halves of their scar.~Fraxel Laser: One half of the scar is treated with Fraxel Laser"
3545|NCT02988219|B3|Baseline|Total|Total of all reporting groups
3737|NCT02967354|O3|Outcome|Obese, Treated With Oral Antidiabetic Drugs + Insulin|BMI>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin
3548|NCT02988219|P2|Participant Flow|Combined General/Epidural (G/E)|General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
3549|NCT02988219|P1|Participant Flow|General Anesthesia (G)|General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
3550|NCT02988219|O2|Outcome|Combined General/Epidural (G/E)|General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position General anesthesia
3551|NCT02988219|O1|Outcome|General Anesthesia (G)|General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
3552|NCT02988219|O2|Outcome|Combined General/Epidural (G/E)|General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position General anesthesia
3553|NCT02988219|O1|Outcome|General Anesthesia (G)|General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
3554|NCT02988219|E2|Reported Event|Combined General/Epidural (G/E)|General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
3555|NCT02988219|E1|Reported Event|General Anesthesia (G)|General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
3556|NCT02987868|B1|Baseline|All Study Participants|"Supplements with the proprietary amino acid derivative blend.~Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative"
3557|NCT02987868|P2|Participant Flow|Placebo First, Then Amino Acid Supplement|"Non-active Placebo first, and after washout period, an orally administered amino acid supplement.~Placebo: A non-active orally administered supplement of the proprietary amino acid derivative~Amino acid supplement: Supplements with the proprietary amino acid derivative blend."
3558|NCT02987868|P1|Participant Flow|Amino Acid Supplement First, Then Placebo|"An orally administered amino acid supplement first, and after washout period, placebo.~Placebo: A non-active orally administered supplement of the proprietary amino acid derivative~Amino acid supplement: Supplements with the proprietary amino acid derivative blend."
3559|NCT02987868|O2|Outcome|Placebo|"Non-active~Placebo: A non-active orally administered supplement of the proprietary amino acid derivative"
3560|NCT02987868|O1|Outcome|Amino Acid Supplement|"Supplements with the proprietary amino acid derivative blend.~Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative"
3561|NCT02987868|E2|Reported Event|Placebo|"Non-active~Placebo: A non-active orally administered supplement of the proprietary amino acid derivative"
3562|NCT02987868|E1|Reported Event|Amino Acid Supplement|"Supplements with the proprietary amino acid derivative blend.~Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative"
3563|NCT02987374|B1|Baseline|2011-2012 Fluzone IIV3 (IM)|"2011-2012 Fluzone IIV3 NDC No 49281-011-50~2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)"
3564|NCT02987374|P1|Participant Flow|2011-2012 Fluzone IIV3 (IM)|"2011-2012 Fluzone IIV3 NDC No 49281-011-50~2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)"
3565|NCT02987374|O1|Outcome|2011-2012 Fluzone IIV3 (IM)|"2011-2012 Fluzone IIV3 NDC No 49281-011-50~2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)"
3566|NCT02987374|O1|Outcome|2011-2012 Fluzone IIV3 (IM)|"2011-2012 Fluzone IIV3 NDC No 49281-011-50~2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)"
3567|NCT02987374|E1|Reported Event|2011-2012 Fluzone IIV3 (IM)|"2011-2012 Fluzone IIV3 NDC No 49281-011-50~2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)"
3568|NCT02987205|B1|Baseline|Split Face Study Bilateral Revanesse Ultra vs Restylane in NLF|Split face study - Revanesse Ultra in the NLF on one side of the face and Restylane on the opposite side of the face for NLF correction, treatment is randomized
3569|NCT02987205|P1|Participant Flow|Bilateral Treatment With Revanesse Ultra and Restylane|Randomized treatment with Revanesse Ultra in the Nasolabial Fold (NLF) on one side of the face, and Restylane on the opposite side of the face - the study is a randomized, multicenter, double blind, split-face study in subjects seeking NLF correction. Subjects were treated with Revanesse Ultra in the NLF on one side of the face and Restylane in the NLF on the other side of the face. The side of the face for each product was randomly assigned.
3570|NCT02987205|O2|Outcome|Restylane|"Restylane injection in the NLF on the other side of the face to optimal correction~Restylane: NLF Correction"
3571|NCT02987205|O1|Outcome|Revanesse Ultra|"Revanesse Ultra in the NLF on one side of the face~Revanesse Ultra: NLF correction"
3572|NCT02987205|O2|Outcome|Restylane|"Restylane injection in the NLF on the other side of the face to optimal correction~Restylane: NLF Correction"
3573|NCT02987205|O1|Outcome|Revanesse Ultra|"Revanesse Ultra in the NLF on one side of the face~Revanesse Ultra: NLF correction"
3574|NCT02987205|E2|Reported Event|Restylane|"Restylane injection in the NLF on the other side of the face to optimal correction~Restylane: NLF Correction"
3575|NCT02987205|E1|Reported Event|Revanesse Ultra|"Revanesse Ultra in the NLF on one side of the face~Revanesse Ultra: NLF correction"
3576|NCT02986282|B1|Baseline|Single Arm|"Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation~ABI measurement using both doppler and oscillometric method."
3577|NCT02986282|P1|Participant Flow|Single Arm|"Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation~ABI measurement using both doppler and oscillometric method"
3578|NCT02986282|O1|Outcome|Single Arm|"Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation~ABI measurement using both doppler and oscillometric method"
3579|NCT02986282|O1|Outcome|Single Arm|"Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation~ABI measurement using both doppler and oscillometric method"
3580|NCT02986282|E1|Reported Event|Single Arm|"Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation~ABI measurement using both doppler and oscillometric method"
3581|NCT02984878|B3|Baseline|Total|Total of all reporting groups
3738|NCT02967354|O2|Outcome|Obese With Oral Antidiabetic Drugs|BMI>30, Type 2 diabetes treated with oral antidiabetic drugs
3582|NCT02984878|B2|Baseline|Revanesse Ultra Optimal Correction|"Revanesse Ultra open label retreatment / Nasolabial Fold correction - optional open-label retreatment with Revanesse Ultra for subjects as needed for optimal correction if WSRS scores had not returned to baseline.~The subjects completing the initial phase of the SYM2014-02 study (NCT02987205) were treated as needed for optimal correction if WSRS scores had not returned to baseline, and were offered the option for retreatment with Revanesse Ultra Safety data was collected to assess treatment emergent adverse events associated with repeat injections. Seventy-one subjects received retreatment - 41 were included in the optimal correction group"
3583|NCT02984878|B1|Baseline|Revanesse Ultra Retreatment|Revanesse Ultra open label retreatment / Nasolabial Fold correction - optional open-label retreatment with Revanesse Ultra for subjects who had returned to baseline Wrinkle Severity Rating Scale (WSRS) score The subjects completing the initial phase of the SYM2014-02 study (NCT02987205) who had returned to baseline Wrinkle Severity Rating Scale (WSRS) score, were offered the option for retreatment with Revanesse Ultra Safety data was collected to assess treatment emergent adverse events associated with repeat injections. Seventy-one subjects received retreatment - 30 returned to baseline
3584|NCT02984878|P2|Participant Flow|Revanesse Ultra Optimal Correction|The Optimal Correction group scores had not returned to baseline, subjects were eligible to be injected for either one or both NLFs as needed to achieve optimal correction (optimal correction group).
3585|NCT02984878|P1|Participant Flow|Revanesse Ultra Retreatment|Revanesse Ultra: Nasolabial Fold correction - - Subjects could have open-label retreatment as needed with Revanesse Ultra at 6 months if their WSRS scores had returned to baseline
3586|NCT02984878|O2|Outcome|Revanesse Ultra Optimal Correction|The Optimal Correction group scores had not returned to baseline, subjects were eligible to be injected for either one or both NLFs as needed to achieve optimal correction (optimal correction group).
3587|NCT02984878|O1|Outcome|Revanesse Ultra Retreatment|Revanesse Ultra: Nasolabial Fold correction - Subjects could have open-label retreatment as needed with Revanesse Ultra at 6 months if their WSRS scores had returned to baseline
3588|NCT02984878|O2|Outcome|Revanesse Ultra Optimal Correction|The Optimal Correction group scores had not returned to baseline, subjects were eligible to be injected for either one or both NLFs as needed to achieve optimal correction (optimal correction group).
3589|NCT02984878|O1|Outcome|Revanesse Ultra Retreatment|Revanesse Ultra: Nasolabial Fold correction - - Subjects could have open-label retreatment as needed with Revanesse Ultra at 6 months if their WSRS scores had returned to baseline
3590|NCT02984878|O2|Outcome|Retreatment Group|Revanesse Ultra open label retreatment for Nasolabial Fold correction. Optional Open-label Retreatment at Visit 6/Week 24 of the SYM 2014-02 Main Study, a subject could be retreated when WSRS scores had returned to baseline for either or both NLFs. The retreatment group and the optimal correction group were separated for data analysis. These subjects continued to day 196 (Visit 7 / week 28), received a phone contact at day 280 (week 40), and completed at day 364 (Visit 8 / week 52).
3591|NCT02984878|O1|Outcome|Optimal Correction Group|Optional Open label Retreatment at Week 24 / SYM2014-02 Retreatment: At SYM 2014-02 Main Study Visit 6/Week 24, a subject could be retreated with Revanesse Ultra. Subjects were eligible for optimal correction when WSRS scores had not returned to baseline. Optimal Correction subjects were injected in either one or both NLFs as needed to achieve optimal correction. These subjects continued to day 196 (Visit 7 / week 28), received a phone contact at day 280 (week 40), and completed at day 364 (Visit 8 / week 52).
3592|NCT02984878|E2|Reported Event|Optimal Correction Group|Optional Open label Retreatment at Week 24 / SYM2014-02 Retreatment: At SYM 2014-02 Main Study Visit 6/Week 24, a subject could be retreated with Revanesse Ultra. Subjects were eligible for optimal correction when WSRS scores had not returned to baseline. Optimal Correction subjects were injected in either one or both NLFs as needed to achieve optimal correction. These subjects continued to day 196 (Visit 7 / week 28), received a phone contact at day 280 (week 40), and completed at day 364 (Visit 8 / week 52).
3593|NCT02984878|E1|Reported Event|Retreatment Group|Revanesse Ultra open label retreatment for Nasolabial Fold correction. Optional Open-label Retreatment at Visit 6/Week 24 of the SYM 2014-02 Main Study, a subject could be retreated when WSRS scores had returned to baseline for either or both NLFs. The retreatment group and the optimal correction group were separated for data analysis. These subjects continued to day 196 (Visit 7 / week 28), received a phone contact at day 280 (week 40), and completed at day 364 (Visit 8 / week 52).
3594|NCT02983981|B1|Baseline|Open Label|"Topicort topical spray~Topicort Topical Spray: open label Topicort spray"
3595|NCT02983981|P1|Participant Flow|Topicort Topical Spray|Topicort spray applied BID for 4 weeks followed by BID on 2 consecutive days through week 16
3596|NCT02983981|O1|Outcome|Open Label|"Topicort topical spray~Topicort Topical Spray: open label Topicort spray"
3597|NCT02983981|O1|Outcome|Open Label|"Topicort topical spray~Topicort Topical Spray: open label Topicort spray"
3598|NCT02983981|O1|Outcome|Open Label|"Topicort topical spray~Topicort Topical Spray: open label Topicort spray"
3599|NCT02983981|O1|Outcome|Open Label|"Topicort topical spray~Topicort Topical Spray: open label Topicort spray"
3600|NCT02983981|E1|Reported Event|Open Label|"Topicort topical spray~Topicort Topical Spray: open label Topicort spray"
3601|NCT02977572|B3|Baseline|Total|Total of all reporting groups
3602|NCT02977572|B2|Baseline|Non-Invasive Ventilation (NIV Group)|"For the NIV group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8–10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%–94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Non-Invasive Ventilation: In arm description"
3657|NCT02971670|P1|Participant Flow|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
3681|NCT02968173|O1|Outcome|Children at High Risk of Severe RSV Infection|A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.
3603|NCT02977572|B1|Baseline|Continuous Positive Airway Pressure (CPAP) Group|"The CPAP was applied by using a flow generator that was capable of delivering a flow of 140 Liter /minute, with adjustable fractional inspired oxygen (FiO2) that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure (PEEP) valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System Flow Jet. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Continuous Positive Airway Pressure: In arm description"
3604|NCT02977572|P2|Participant Flow|Continuous Positive Airway Pressure (CPAP) Group|"The Continuous Positive Airway Pressure was applied by using a flow generator that was capable of delivering a flow of 140 Liter/minute, with adjustable fractional inspired oxygen that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Continuous Positive Airway Pressure: In arm description"
3605|NCT02977572|P1|Participant Flow|Non-Invasive Ventilation (NIV Group)|"For the Non-Invasive ventilation group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8–10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%–94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Non-Invasive Ventilation: In arm description"
3606|NCT02977572|O2|Outcome|Continuous Positive Airway Pressure (CPAP) Group|"The Continuous Positive Airway Pressure was applied by using a flow generator that was capable of delivering a flow of 140 Liter/minute, with adjustable fractional inspired oxygen that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Continuous Positive Airway Pressure: In arm description"
3607|NCT02977572|O1|Outcome|Non-Invasive Ventilation (NIV Group)|"For the Non-Invasive ventilation group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8–10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%–94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Non-Invasive Ventilation: In arm description"
3608|NCT02977572|O2|Outcome|Continuous Positive Airway Pressure (CPAP) Group|"The Continuous Positive Airway Pressure was applied by using a flow generator that was capable of delivering a flow of 140 Liter/minute, with adjustable fractional inspired oxygen that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Continuous Positive Airway Pressure: In arm description"
3609|NCT02977572|O1|Outcome|Non-Invasive Ventilation (NIV Group)|"For the Non-Invasive ventilation group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8–10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%–94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Non-Invasive Ventilation: In arm description"
3610|NCT02977572|O2|Outcome|Continuous Positive Airway Pressure (CPAP) Group|"The Continuous Positive Airway Pressure was applied by using a flow generator that was capable of delivering a flow of 140 Liter/minute, with adjustable fractional inspired oxygen that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Continuous Positive Airway Pressure: In arm description"
3728|NCT02967354|O2|Outcome|Obese With Oral Antidiabetic Drugs|BMI>30, Type 2 diabetes treated with oral antidiabetic drugs
3729|NCT02967354|O1|Outcome|Healthy Control|Healthy control.
3611|NCT02977572|O1|Outcome|Non-Invasive Ventilation (NIV Group)|"For the Non-Invasive ventilation group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8–10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%–94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Non-Invasive Ventilation: In arm description"
3612|NCT02977572|O2|Outcome|Continuous Positive Airway Pressure (CPAP) Group|"The Continuous Positive Airway Pressure was applied by using a flow generator that was capable of delivering a flow of 140 Liter/minute, with adjustable fractional inspired oxygen that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Continuous Positive Airway Pressure: In arm description"
3613|NCT02977572|O1|Outcome|Non-Invasive Ventilation (NIV Group)|"For the Non-Invasive ventilation group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8–10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%–94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Non-Invasive Ventilation: In arm description"
3614|NCT02977572|O2|Outcome|Continuous Positive Airway Pressure (CPAP) Group|"The Continuous Positive Airway Pressure was applied by using a flow generator that was capable of delivering a flow of 140 Liter/minute, with adjustable fractional inspired oxygen that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Continuous Positive Airway Pressure: In arm description"
3615|NCT02977572|O1|Outcome|Non-Invasive Ventilation (NIV Group)|"For the Non-Invasive ventilation group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8–10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%–94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Non-Invasive Ventilation: In arm description"
3616|NCT02977572|O2|Outcome|Continuous Positive Airway Pressure (CPAP) Group|"The Continuous Positive Airway Pressure was applied by using a flow generator that was capable of delivering a flow of 140 Liter/minute, with adjustable fractional inspired oxygen that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Continuous Positive Airway Pressure: In arm description"
3617|NCT02977572|O1|Outcome|Non-Invasive Ventilation (NIV Group)|"For the Non-Invasive ventilation group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8–10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%–94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Non-Invasive Ventilation: In arm description"
3618|NCT02977572|O2|Outcome|Non-Invasive Ventilation (NIV Group)|"For the NIV group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8–10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%–94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Non-Invasive Ventilation: In arm description"
3658|NCT02971670|O4|Outcome|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
3659|NCT02971670|O3|Outcome|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
3619|NCT02977572|O1|Outcome|Continuous Positive Airway Pressure (CPAP) Group|"The CPAP was applied by using a flow generator that was capable of delivering a flow of 140 Liter /minute, with adjustable fractional inspired oxygen (FiO2) that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure (PEEP) valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System Flow Jet. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Continuous Positive Airway Pressure: In arm description"
3620|NCT02977572|O2|Outcome|Continuous Positive Airway Pressure (CPAP) Group|"The Continuous Positive Airway Pressure was applied by using a flow generator that was capable of delivering a flow of 140 Liter/minute, with adjustable fractional inspired oxygen that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Continuous Positive Airway Pressure: In arm description"
3621|NCT02977572|O1|Outcome|Non-Invasive Ventilation (NIV Group)|"For the Non-Invasive ventilation group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8–10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%–94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Non-Invasive Ventilation: In arm description"
3622|NCT02977572|O2|Outcome|Continuous Positive Airway Pressure (CPAP) Group|"The CPAP was applied by using a flow generator that was capable of delivering a flow of 140 Liter /minute, with adjustable fractional inspired oxygen (FiO2) that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure (PEEP) valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System Flow Jet. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Continuous Positive Airway Pressure: In arm description"
3623|NCT02977572|O1|Outcome|Non-Invasive Ventilation (NIV Group)|"For the NIV group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8–10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%–94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Non-Invasive Ventilation: In arm description"
3624|NCT02977572|E2|Reported Event|Continuous Positive Airway Pressure (CPAP) Group|"The CPAP was applied by using a flow generator that was capable of delivering a flow of 140 Liter /minute, with adjustable fractional inspired oxygen (FiO2) that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure (PEEP) valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System Flow Jet. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Continuous Positive Airway Pressure: In arm description"
3625|NCT02977572|E1|Reported Event|Non-Invasive Ventilation (NIV Group)|"For the NIV group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8–10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%–94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Non-Invasive Ventilation: In arm description"
3626|NCT02974543|B3|Baseline|Total|Total of all reporting groups
3627|NCT02974543|B2|Baseline|Sham 1st (Auditory Only) Then Active (Bimodal)|To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. During active treatment, the device will deliver electric somatosensory and auditory stimulation. Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment. Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, determined by how the subject can modulate the tinnitus. The auditory stimulus will be individualized based on subjects' tinnitus spectrum.
3730|NCT02967354|O5|Outcome|Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin|BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin
3628|NCT02974543|B1|Baseline|Active 1st (Bimodal) Then Sham (Auditory Only)|During active treatment the device will deliver electric somatosensory and auditory stimulation. To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment. Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, determined by how the subject can modulate the tinnitus. The auditory stimulus will be individualized based on subjects' tinnitus spectrum.
3629|NCT02974543|P2|Participant Flow|Active (Bimodal) Then Sham (Auditory Only)|"During active treatment, the device will deliver electric somatosensory and auditory stimulation.~To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.~Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment.~Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.~The auditory stimulus will be individualized based on s"
3630|NCT02974543|P1|Participant Flow|Sham 1st (Auditory Only) Then Active (Bimodal)|"To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.~During active treatment, the device will deliver electric somatosensory and auditory stimulation.~Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment.~Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.~The auditory stimulus will be individualized based on s"
3631|NCT02974543|O6|Outcome|Active After Sham|
3632|NCT02974543|O5|Outcome|Washout After Sham|
3633|NCT02974543|O4|Outcome|Sham Before Active|
3634|NCT02974543|O3|Outcome|Sham After Active|
3635|NCT02974543|O2|Outcome|Washout After Active|
3636|NCT02974543|O1|Outcome|Active Before Sham|
3637|NCT02974543|O6|Outcome|Active After Sham|
3638|NCT02974543|O5|Outcome|Washout After Sham|
3639|NCT02974543|O4|Outcome|Sham Before Active|
3640|NCT02974543|O3|Outcome|Sham After Active|
3641|NCT02974543|O2|Outcome|Washout After Active|
3642|NCT02974543|O1|Outcome|Active Before Sham|
3643|NCT02974543|E6|Reported Event|Active After Sham|
3644|NCT02974543|E5|Reported Event|Washout After Sham|
3645|NCT02974543|E4|Reported Event|Sham Before Active|
3646|NCT02974543|E3|Reported Event|Sham After Active|
3647|NCT02974543|E2|Reported Event|Washout After Active|
3648|NCT02974543|E1|Reported Event|Active Before Sham|
3649|NCT02971670|B5|Baseline|Total|Total of all reporting groups
3650|NCT02971670|B4|Baseline|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
3651|NCT02971670|B3|Baseline|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
3652|NCT02971670|B2|Baseline|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
3653|NCT02971670|B1|Baseline|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
3654|NCT02971670|P4|Participant Flow|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
3655|NCT02971670|P3|Participant Flow|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
3656|NCT02971670|P2|Participant Flow|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
3731|NCT02967354|O4|Outcome|Normal Weight, Treated With Oral Antidiabetic Drugs|BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs
3660|NCT02971670|O2|Outcome|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
3661|NCT02971670|O1|Outcome|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
3662|NCT02971670|O4|Outcome|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
3663|NCT02971670|O3|Outcome|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
3664|NCT02971670|O2|Outcome|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
3665|NCT02971670|O1|Outcome|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
3666|NCT02971670|O4|Outcome|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
3667|NCT02971670|O3|Outcome|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
3668|NCT02971670|O2|Outcome|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
3669|NCT02971670|O1|Outcome|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
3670|NCT02971670|E4|Reported Event|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
3671|NCT02971670|E3|Reported Event|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
3672|NCT02971670|E2|Reported Event|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
3673|NCT02971670|E1|Reported Event|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
3674|NCT02968173|B1|Baseline|Children at High Risk of Severe RSV Infection|A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.
3675|NCT02968173|P1|Participant Flow|Children at High Risk of Severe RSV Infection|A single intramuscular (IM) injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the respiratory syncytial virus (RSV) season a participant was enrolled.
3676|NCT02968173|O1|Outcome|Children at High Risk of Severe RSV Infection|A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.
3677|NCT02968173|O1|Outcome|Children at High Risk of Severe RSV Infection|A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.
3678|NCT02968173|O1|Outcome|Children at High Risk of Severe RSV Infection|A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.
3679|NCT02968173|O1|Outcome|Children at High Risk of Severe RSV Infection|A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.
3680|NCT02968173|O1|Outcome|Children at High Risk of Severe RSV Infection|A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.
3682|NCT02968173|O1|Outcome|Children at High Risk of Severe RSV Infection|A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.
3683|NCT02968173|O1|Outcome|Children at High Risk of Severe RSV Infection|A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.
3684|NCT02968173|E2|Reported Event|PALIVIZUMAB TEAE Within 100 Days|"A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.~TEAEs are defined as those that began after the first dose of study drug but within 100 days (+ 100 day assessment period) after the last dose of study drug."
3685|NCT02968173|E1|Reported Event|PALIVIZUMAB TEAE Within 30 Days|"A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.~Treatment-emergent adverse events (TEAEs) are defined as those that began after the first dose of study drug but within 30 days (+ 30 day assessment period) after the last dose of study drug."
3686|NCT02967393|B3|Baseline|Total|Total of all reporting groups
3687|NCT02967393|B2|Baseline|IIV4|"0.5 mL intramuscular injection~IIV4"
3688|NCT02967393|B1|Baseline|ccIIV4|"0.5 mL intramuscular injection~ccIIV4"
3689|NCT02967393|P2|Participant Flow|IIV4|"0.5 mL intramuscular injection~IIV4"
3690|NCT02967393|P1|Participant Flow|ccIIV4|"0.5 mL intramuscular injection~ccIIV4"
3691|NCT02967393|O2|Outcome|IIV4|"0.5 mL intramuscular injection~IIV4"
3692|NCT02967393|O1|Outcome|ccIIV4|"0.5 mL intramuscular injection~ccIIV4"
3693|NCT02967393|O2|Outcome|IIV4|"0.5 mL intramuscular injection~IIV4"
3694|NCT02967393|O1|Outcome|ccIIV4|"0.5 mL intramuscular injection~ccIIV4"
3695|NCT02967393|O2|Outcome|IIV4|"0.5 mL intramuscular injection~IIV4"
3696|NCT02967393|O1|Outcome|ccIIV4|"0.5 mL intramuscular injection~ccIIV4"
3697|NCT02967393|O2|Outcome|IIV4|"0.5 mL intramuscular injection~IIV4"
3698|NCT02967393|O1|Outcome|ccIIV4|"0.5 mL intramuscular injection~ccIIV4"
3699|NCT02967393|O2|Outcome|IIV4|"0.5 mL intramuscular injection~IIV4"
3700|NCT02967393|O1|Outcome|ccIIV4|"0.5 mL intramuscular injection~ccIIV4"
3701|NCT02967393|O1|Outcome|All Participants|Participants from both arms
3702|NCT02967393|O1|Outcome|All Participants|Participants from both arms
3703|NCT02967393|O1|Outcome|All Participants|Participants from both arms
3704|NCT02967393|O1|Outcome|All Participants|Participants from both arms
3705|NCT02967393|O1|Outcome|All Participants|Participants from both arms
3706|NCT02967393|O1|Outcome|All Participants|Participants from both arms
3707|NCT02967393|O1|Outcome|All Participants|Participants from both arms
3708|NCT02967393|O1|Outcome|All Participants|Participants from both arms
3709|NCT02967393|O1|Outcome|All Participants|Participants from both arms
3710|NCT02967393|O1|Outcome|All Participants|Participants from both arms
3711|NCT02967393|O1|Outcome|All Parents|Parents of participants from both arms
3712|NCT02967393|E2|Reported Event|IIV4|"0.5 mL intramuscular injection~IIV4"
3713|NCT02967393|E1|Reported Event|ccIIV4|"0.5 mL intramuscular injection~ccIIV4"
3714|NCT02967354|B6|Baseline|Total|Total of all reporting groups
3715|NCT02967354|B5|Baseline|Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin|"BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
3716|NCT02967354|B4|Baseline|Normal Weight, Treated With Oral Antidiabetic Drugs|"BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
3717|NCT02967354|B3|Baseline|Obese, Treated With Oral Antidiabetic Drugs + Insulin|"BMI>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
3718|NCT02967354|B2|Baseline|Obese With Oral Antidiabetic Drugs|"BMI>30, Type 2 diabetes treated with oral antidiabetic drugs~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
3719|NCT02967354|B1|Baseline|Healthy Control|"Healthy control~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
3720|NCT02967354|P5|Participant Flow|Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin|"BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
3721|NCT02967354|P4|Participant Flow|Normal Weight, Treated With Oral Antidiabetic Drugs|"BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
3722|NCT02967354|P3|Participant Flow|Obese, Treated With Oral Antidiabetic Drugs + Insulin|"BMI>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
3723|NCT02967354|P2|Participant Flow|Obese With Oral Antidiabetic Drugs|"BMI>30, Type 2 diabetes treated with oral antidiabetic drugs~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
3724|NCT02967354|P1|Participant Flow|Healthy Control|"Healthy control~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
3725|NCT02967354|O5|Outcome|Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin|BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin
3726|NCT02967354|O4|Outcome|Normal Weight, Treated With Oral Antidiabetic Drugs|BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs
3727|NCT02967354|O3|Outcome|Obese, Treated With Oral Antidiabetic Drugs + Insulin|BMI>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin
3740|NCT02967354|O5|Outcome|Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin|BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin
3741|NCT02967354|O4|Outcome|Normal Weight, Treated With Oral Antidiabetic Drugs|BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs
3742|NCT02967354|O3|Outcome|Obese, Treated With Oral Antidiabetic Drugs + Insulin|BMI>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin
3743|NCT02967354|O2|Outcome|Obese With Oral Antidiabetic Drugs|BMI>30, Type 2 diabetes treated with oral antidiabetic drugs
3744|NCT02967354|O1|Outcome|Healthy Control|Healthy control.
3745|NCT02967354|O5|Outcome|Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin|"BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
3746|NCT02967354|O4|Outcome|Normal Weight, Treated With Oral Antidiabetic Drugs|"BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
3747|NCT02967354|O3|Outcome|Obese, Treated With Oral Antidiabetic Drugs + Insulin|"BMI>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
3748|NCT02967354|O2|Outcome|Obese With Oral Antidiabetic Drugs|"BMI>30, Type 2 diabetes treated with oral antidiabetic drugs~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
3749|NCT02967354|O1|Outcome|Healthy Control|"Healthy control~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
3750|NCT02967354|E5|Reported Event|Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin|"BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
3751|NCT02967354|E4|Reported Event|Normal Weight, Treated With Oral Antidiabetic Drugs|"BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
3752|NCT02967354|E3|Reported Event|Obese, Treated With Oral Antidiabetic Drugs + Insulin|"BMI>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
3753|NCT02967354|E2|Reported Event|Obese With Oral Antidiabetic Drugs|"BMI>30, Type 2 diabetes treated with oral antidiabetic drugs~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
3754|NCT02967354|E1|Reported Event|Healthy Control|"Healthy control~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
3755|NCT02966509|B3|Baseline|Total|Total of all reporting groups
3756|NCT02966509|B2|Baseline|B: Control Group Arm|All participants randomized to Arm B will receive usual oncologic care.
3757|NCT02966509|B1|Baseline|A: Intervention Arm|"All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.~EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study."
3758|NCT02966509|P2|Participant Flow|B: Control Group Arm|All participants randomized to Arm B will receive usual oncologic care.
3759|NCT02966509|P1|Participant Flow|A: Intervention Arm|"All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.~EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study."
3760|NCT02966509|O2|Outcome|B: Control Group Arm|All participants randomized to Arm B will receive usual oncologic care.
3761|NCT02966509|O1|Outcome|A: Intervention Arm|"All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.~EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study."
3762|NCT02966509|O2|Outcome|B: Control Group Arm|All participants randomized to Arm B will receive usual oncologic care.
3763|NCT02966509|O1|Outcome|A: Intervention Arm|"All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.~EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study."
3764|NCT02966509|O2|Outcome|B: Control Group Arm|All participants randomized to Arm B will receive usual oncologic care.
3765|NCT02966509|O1|Outcome|A: Intervention Arm|"All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.~EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study."
3766|NCT02966509|O2|Outcome|B: Control Group Arm|All participants randomized to Arm B will receive usual oncologic care.
3767|NCT02966509|O1|Outcome|A: Intervention Arm|"All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.~EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study."
3768|NCT02966509|O2|Outcome|B: Control Group Arm|All participants randomized to Arm B will receive usual oncologic care.
3769|NCT02966509|O1|Outcome|A: Intervention Arm|"All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.~EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study."
20025|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
3771|NCT02966509|O1|Outcome|A: Intervention Arm|"All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.~EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study."
3772|NCT02966509|O2|Outcome|B: Control Group Arm|All participants randomized to Arm B will receive usual oncologic care.
3773|NCT02966509|O1|Outcome|A: Intervention Arm|"All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.~EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study."
3774|NCT02966509|O2|Outcome|B: Control Group Arm|All participants randomized to Arm B will receive usual oncologic care.
3775|NCT02966509|O1|Outcome|A: Intervention Arm|"All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.~EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study."
3776|NCT02966509|O2|Outcome|B: Control Group Arm|All participants randomized to Arm B will receive usual oncologic care.
3777|NCT02966509|O1|Outcome|A: Intervention Arm|"All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.~EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study."
3778|NCT02966509|O2|Outcome|B: Control Group Arm|All participants randomized to Arm B will receive usual oncologic care.
3779|NCT02966509|O1|Outcome|A: Intervention Arm|"All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.~EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study."
3780|NCT02966509|E2|Reported Event|B: Control Group Arm|All participants randomized to Arm B will receive usual oncologic care.
3781|NCT02966509|E1|Reported Event|A: Intervention Arm|"All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.~EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study."
3782|NCT02966015|B3|Baseline|Total|Total of all reporting groups
3783|NCT02966015|B2|Baseline|Traditional Sleeve Catheter Users|The traditional sleeve catheter users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial.
3784|NCT02966015|B1|Baseline|Tiemann/Coudé Users|"The Tiemann/Coudé users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial.~Coloplast test catheter: This is a newly developed catheter"
3785|NCT02966015|P2|Participant Flow|Traditional Sleeve Catheter Users|The traditional sleeve catheter users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial.
3786|NCT02966015|P1|Participant Flow|Tiemann/Coudé Users|"The Tiemann/Coudé users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial.~Coloplast test catheter: This is a newly developed catheter"
3787|NCT02966015|O2|Outcome|Traditional Sleeve Catheter Users|The traditional sleeve catheter users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial.
3788|NCT02966015|O1|Outcome|Tiemann/Coudé Users|"The Tiemann/Coudé users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial.~Coloplast test catheter: This is a newly developed catheter"
3789|NCT02966015|E2|Reported Event|Traditional Sleeve Catheter Users|The traditional sleeve catheter users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial.
3790|NCT02966015|E1|Reported Event|Tiemann/Coudé Users|"The Tiemann/Coudé users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial.~Coloplast test catheter: This is a newly developed catheter"
3791|NCT02966002|B1|Baseline|Intervention: Aspirin|"650 mg. Twice a day for 8 weeks~Aspirin"
3792|NCT02966002|P1|Participant Flow|Intervention: Aspirin|"650 mg. Twice a day for 8 weeks~Aspirin"
3793|NCT02966002|O1|Outcome|Intervention: Aspirin|"650 mg. Twice a day for 8 weeks~Aspirin"
3794|NCT02966002|O1|Outcome|Intervention: Aspirin|"650 mg. Twice a day for 8 weeks~Aspirin"
3795|NCT02966002|O1|Outcome|Intervention: Aspirin|"650 mg. Twice a day for 8 weeks~Aspirin"
3796|NCT02966002|O1|Outcome|Intervention: Aspirin|"650 mg. Twice a day for 8 weeks~Aspirin"
3797|NCT02966002|E1|Reported Event|Intervention: Aspirin|"650 mg. Twice a day for 8 weeks~Aspirin"
3798|NCT02965833|B1|Baseline|Overall|3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix and subject's HMPS used during Period 1 and Period 2 in a crossover assignment.
3956|NCT02956460|O1|Outcome|Fanfilcon A|Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.
3799|NCT02965833|P2|Participant Flow|HMPS/CCP|Subject's habitual multi-purpose contact lens solution in Period 1, followed by 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
3800|NCT02965833|P1|Participant Flow|CCP/HMPS|3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution (CCP) in Period 1, followed by subject's habitual multi-purpose contact lens solution (HMPS) in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
3801|NCT02965833|O2|Outcome|HMPS|Subject's habitual multi-purpose contact lens solution used daily with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
3802|NCT02965833|O1|Outcome|CLEAR CARE PLUS|3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution used daily with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
3803|NCT02965833|E2|Reported Event|HMPS|All subjects exposed to habitual multi-purpose contact lens solution
3804|NCT02965833|E1|Reported Event|CLEAR CARE PLUS|All subjects exposed to CCP contact lens solution
3805|NCT02965820|B1|Baseline|Overall|OFPM and HMPS used during Period 1 and Period 2 in a crossover assignment.
3806|NCT02965820|P2|Participant Flow|HMPS/OFPM|Subject’s habitual multi-purpose contact lens solution in Period1, followed by OPTI-FREE® PureMoist® contact lens solution in Period 2. Each product used daily per packaging instructions with subject’s habitual contact lenses for approximately 30 cleaning and disinfection cycles.
3807|NCT02965820|P1|Participant Flow|OFPM/HMPS|OPTI-FREE® PureMoist® (OFPM) multi-purpose contact lens solution in Period 1, followed by subject’s habitual multi-purpose contact lens solution (HMPS) in Period 2. Each product used daily per packaging instructions with subject’s habitual contact lenses for approximately 30 cleaning and disinfection cycles.
3808|NCT02965820|O2|Outcome|HMPS|Subject’s habitual multi-purpose contact lens solution used daily per packaging instructions with subject’s habitual contact lenses for approximately 30 cleaning and disinfection cycles.
3809|NCT02965820|O1|Outcome|OFPM|OPTI-FREE® PureMoist® multi-purpose contact lens solution used daily per packaging instructions with subject’s habitual contact lenses for approximately 30 cleaning and disinfection cycles.
3810|NCT02965820|E2|Reported Event|HMPS|All subjects exposed to habitual multi-purpose contact lens solution
3811|NCT02965820|E1|Reported Event|OFPM|All subjects exposed to OPTI-FREE® PureMoist® multi-purpose contact lens solution
3812|NCT02964767|B3|Baseline|Total|Total of all reporting groups
3813|NCT02964767|B2|Baseline|2.HIV/Tb.|Patients with HIV/Tb. co infections
3814|NCT02964767|B1|Baseline|1.HIV|patients with mono HIV infections
3815|NCT02964767|P2|Participant Flow|HIV/Tb.|Patients with HIV/Tb. co infection
3816|NCT02964767|P1|Participant Flow|HIV,|HIV mono infected patients,
3817|NCT02964767|O2|Outcome|2.HIV/Tb.|Patients with HIV/Tb. co infections
3818|NCT02964767|O1|Outcome|1.HIV|HIV patients only
3819|NCT02964767|O1|Outcome|Prevalence of HIV/Tb. co Infection|Percentage of Tb. co infections among HIV patients enrolled at ART center.
3820|NCT02964767|E2|Reported Event|HIV/Tb. co Infections|Patients with HIV-Tb. co infections
3821|NCT02964767|E1|Reported Event|HIV,|HIV patients
3822|NCT02962882|B1|Baseline|Mepilex Border Dressing Heel and Sacrum Together|"A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI).~Mepilex Border: Multi-layer Foam Dressings"
3823|NCT02962882|P1|Participant Flow|Mepilex Border Dressing All|"A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI).~Mepilex Border: Multi-layer Foam Dressings"
3824|NCT02962882|O2|Outcome|Mepilex Border Dressing Sacrum|"A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI).~Mepilex Border: Multi-layer Foam Dressings"
3825|NCT02962882|O1|Outcome|Mepilex Border Dressing Heel|"A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI).~Mepilex Border: Multi-layer Foam Dressings"
3826|NCT02962882|O2|Outcome|Mepilex Border Dressing Sacrum|"A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI).~Mepilex Border: Multi-layer Foam Dressings"
3827|NCT02962882|O1|Outcome|Mepilex Border Dressing Heel|"A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI).~Mepilex Border: Multi-layer Foam Dressings"
3828|NCT02962882|O2|Outcome|Mepilex Border Dressing Sacrum|"A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI).~Mepilex Border: Multi-layer Foam Dressings"
3829|NCT02962882|O1|Outcome|Mepilex Border Dressing Heel|"A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI).~Mepilex Border: Multi-layer Foam Dressings"
3830|NCT02962882|E1|Reported Event|Mepilex Border Dressing All|"A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI).~Mepilex Border: Multi-layer Foam Dressings"
3831|NCT02961244|B3|Baseline|Total|Total of all reporting groups
3832|NCT02961244|B2|Baseline|Intervention Group|"Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.~Prewarming and perioperative warming with Forced Air Warming device and its blankets.~Forced Air Warming blanket"
3833|NCT02961244|B1|Baseline|Control Group|Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
3834|NCT02961244|P2|Participant Flow|Intervention Group|"Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.~Prewarming and perioperative warming with Forced Air Warming device and its blankets.~Forced Air Warming blanket"
3835|NCT02961244|P1|Participant Flow|Control Group|Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
3836|NCT02961244|O2|Outcome|Intervention Group|"Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.~Prewarming and perioperative warming with Forced Air Warming device and its blankets.~Forced Air Warming blanket"
3837|NCT02961244|O1|Outcome|Control Group|Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
3838|NCT02961244|O2|Outcome|Intervention Group|"Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.~Prewarming and perioperative warming with Forced Air Warming device and its blankets.~Forced Air Warming blanket"
3839|NCT02961244|O1|Outcome|Control Group|Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
3840|NCT02961244|E2|Reported Event|Intervention Group|"Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.~Prewarming and perioperative warming with Forced Air Warming device and its blankets.~Forced Air Warming blanket"
3841|NCT02961244|E1|Reported Event|Control Group|Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
3842|NCT02959840|B4|Baseline|Total|Total of all reporting groups
3843|NCT02959840|B3|Baseline|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
3844|NCT02959840|B2|Baseline|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia~Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.~Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
3845|NCT02959840|B1|Baseline|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
3846|NCT02959840|P3|Participant Flow|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
3847|NCT02959840|P2|Participant Flow|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia~Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.~Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
3848|NCT02959840|P1|Participant Flow|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
3849|NCT02959840|O3|Outcome|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
3850|NCT02959840|O2|Outcome|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia~Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.~Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
3851|NCT02959840|O1|Outcome|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
3852|NCT02959840|O3|Outcome|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
3853|NCT02959840|O2|Outcome|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia~Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.~Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
3854|NCT02959840|O1|Outcome|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
3855|NCT02959840|O3|Outcome|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
3856|NCT02959840|O2|Outcome|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia~Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.~Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
3857|NCT02959840|O1|Outcome|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
3858|NCT02959840|O3|Outcome|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
3859|NCT02959840|O2|Outcome|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia~Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.~Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
3860|NCT02959840|O1|Outcome|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
3957|NCT02956460|E2|Reported Event|Senofilcon A|Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study
3861|NCT02959840|O3|Outcome|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
3862|NCT02959840|O2|Outcome|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia~Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.~Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
3863|NCT02959840|O1|Outcome|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
3864|NCT02959840|O3|Outcome|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
3865|NCT02959840|O2|Outcome|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia~Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.~Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
3866|NCT02959840|O1|Outcome|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
3867|NCT02959840|O3|Outcome|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
3868|NCT02959840|O2|Outcome|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia~Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.~Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
3869|NCT02959840|O1|Outcome|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
3870|NCT02959840|O3|Outcome|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
3871|NCT02959840|O2|Outcome|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia~Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.~Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
3872|NCT02959840|O1|Outcome|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
3873|NCT02959840|O3|Outcome|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
3874|NCT02959840|O2|Outcome|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia~Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.~Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
3875|NCT02959840|O1|Outcome|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
3876|NCT02959840|O3|Outcome|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
3877|NCT02959840|O2|Outcome|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia~Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.~Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
3878|NCT02959840|O1|Outcome|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
3879|NCT02959840|O3|Outcome|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
3880|NCT02959840|O2|Outcome|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia~Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.~Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
3881|NCT02959840|O1|Outcome|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
3882|NCT02959840|O3|Outcome|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
3883|NCT02959840|O2|Outcome|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia~Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.~Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
3884|NCT02959840|O1|Outcome|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
3885|NCT02959840|E3|Reported Event|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
3916|NCT02958787|P1|Participant Flow|Intervention|"Vessel Sparing Radiation Therapy using MRI based treatment planning to limit dose to critical erectile structures~Radiation Therapy: Radiation Therapy Using MRI Based Treatment Planning"
8328|NCT02743780|E3|Reported Event|MGV354 0.1% Part 1|1 drop in the study eye
3886|NCT02959840|E2|Reported Event|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia~Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.~Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
3887|NCT02959840|E1|Reported Event|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
3888|NCT02958995|B3|Baseline|Total|Total of all reporting groups
3889|NCT02958995|B2|Baseline|Survey Responders Cohort|A subset of KPNC members who completed the Kaiser Diabetes Registry Survey in 1994-1996 and among a random sample of KPNC members who completed the Member Health Survey (MHS), in 1996, 1999, 2002, or 2005 were followed up to 15 years (1997-2011) in this epidemiological study.
3890|NCT02958995|B1|Baseline|Full KPNC Cohort|Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.
3891|NCT02958995|P2|Participant Flow|Survey Responders Cohort|A subset of KPNC members who completed the Kaiser Diabetes Registry Survey in 1994-1996 and among a random sample of KPNC members who completed the Member Health Survey (MHS), in 1996, 1999, 2002, or 2005 were followed up to 15 years (1997-2011) in this epidemiological study.
3892|NCT02958995|P1|Participant Flow|Full KPNC Cohort|Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.
3893|NCT02958995|O2|Outcome|Survey Responders Cohort|A subset of KPNC members who completed the Kaiser Diabetes Registry Survey in 1994-1996 and among a random sample of KPNC members who completed the Member Health Survey (MHS), in 1996, 1999, 2002, or 2005 were followed up to 15 years (1997-2011) in this epidemiological study.
3894|NCT02958995|O1|Outcome|Full KPNC Cohort|Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.
3895|NCT02958995|O2|Outcome|Survey Responders Cohort|A subset of KPNC members who completed the Kaiser Diabetes Registry Survey in 1994-1996 and among a random sample of KPNC members who completed the Member Health Survey (MHS), in 1996, 1999, 2002, or 2005 were followed up to 15 years (1997-2011) in this epidemiological study.
3896|NCT02958995|O1|Outcome|Full KPNC Cohort|Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.
3897|NCT02958995|E2|Reported Event|Survey Responders Cohort|A subset of KPNC members who completed the Kaiser Diabetes Registry Survey in 1994-1996 and among a random sample of KPNC members who completed the Member Health Survey (MHS), in 1996, 1999, 2002, or 2005 were followed up to 15 years (1997-2011) in this epidemiological study.
3898|NCT02958995|E1|Reported Event|Full KPNC Cohort|Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.
3899|NCT02958956|B3|Baseline|Total|Total of all reporting groups
3900|NCT02958956|B2|Baseline|Never User of Pioglitazone|Never user of pioglitazone, which included participants receiving no diabetes medications, with fewer than 2 pioglitazone prescription fills in a 6-month period, and with use of diabetes medications other than pioglitazone.
3901|NCT02958956|B1|Baseline|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
3902|NCT02958956|P2|Participant Flow|Never User of Pioglitazone|Never user of pioglitazone, which included participants receiving no diabetes medications, with fewer than 2 pioglitazone prescription fills in a 6-month period, and with use of diabetes medications other than pioglitazone.
3903|NCT02958956|P1|Participant Flow|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
3904|NCT02958956|O1|Outcome|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
3905|NCT02958956|O1|Outcome|Full Cohort|Participants with diabetes who were members of the KPNC registry, who received (ever use) at least 2 prescriptions for pioglitazone within a 6-month period or who did not receive pioglitazone were followed up to 15.5 years (1997-2012) in this observational study.
3906|NCT02958956|O1|Outcome|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
3907|NCT02958956|O1|Outcome|Full Cohort|Participants with diabetes who were members of the KPNC registry, who received (ever use) at least 2 prescriptions for pioglitazone within a 6-month period or who did not receive pioglitazone were followed up to 15.5 years (1997-2012) in this observational study.
3908|NCT02958956|O1|Outcome|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
3909|NCT02958956|O1|Outcome|Full Cohort|Participants with diabetes who were members of the KPNC registry, who received (ever use) at least 2 prescriptions for pioglitazone within a 6-month period or who did not receive pioglitazone were followed up to 15.5 years (1997-2012) in this observational study.
3910|NCT02958956|O2|Outcome|Never User of Pioglitazone|Never user of pioglitazone, which included participants receiving no diabetes medications, with fewer than 2 pioglitazone prescription fills in a 6-month period, and with use of diabetes medications other than pioglitazone.
3911|NCT02958956|O1|Outcome|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
3912|NCT02958956|O1|Outcome|Full Cohort|Participants with diabetes who were members of the KPNC registry, who received (ever use) at least 2 prescriptions for pioglitazone within a 6-month period or who did not receive pioglitazone were followed up to 15.5 years (1997-2012) in this observational study.
3913|NCT02958956|E2|Reported Event|Never User of Pioglitazone|Never user of pioglitazone, which included participants receiving no diabetes medications, with fewer than 2 pioglitazone prescription fills in a 6-month period, and with use of diabetes medications other than pioglitazone.
3914|NCT02958956|E1|Reported Event|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
3915|NCT02958787|B1|Baseline|Intervention|"Vessel Sparing Radiation Therapy using MRI based treatment planning to limit dose to critical erectile structures~Radiation Therapy: Radiation Therapy Using MRI Based Treatment Planning"
3917|NCT02958787|O1|Outcome|Intervention|"Vessel Sparing Radiation Therapy using MRI based treatment planning to limit dose to critical erectile structures~Radiation Therapy: Radiation Therapy Using MRI Based Treatment Planning"
3918|NCT02958787|E1|Reported Event|Intervention|"Vessel Sparing Radiation Therapy using MRI based treatment planning to limit dose to critical erectile structures~Radiation Therapy: Radiation Therapy Using MRI Based Treatment Planning"
3919|NCT02958345|B3|Baseline|Total|Total of all reporting groups
3920|NCT02958345|B2|Baseline|Placebo|"Subjects randomized to placebo will receive an injection of 0.65 mL of sterile normal saline subcutaneously in the deltoid region of the upper arm.~Placebo: Injection of 0.65 mL of sterile normal saline"
3921|NCT02958345|B1|Baseline|Zostavax|"Subjects will receive 0.65 mL of Zostavax subcutaneously in the deltoid region of the upper arm.~Zostavax: Vaccination with one dose of Zostavax per Zostavax package insert"
3922|NCT02958345|P2|Participant Flow|Placebo|"Subjects randomized to placebo will receive an injection of 0.65 mL of sterile normal saline subcutaneously in the deltoid region of the upper arm.~Placebo: Injection of 0.65 mL of sterile normal saline"
3923|NCT02958345|P1|Participant Flow|Zostavax|"Subjects will receive 0.65 mL of Zostavax subcutaneously in the deltoid region of the upper arm.~Zostavax: Vaccination with one dose of Zostavax per Zostavax package insert"
3924|NCT02958345|O2|Outcome|Placebo|"Subjects randomized to placebo will receive an injection of 0.65 mL of sterile normal saline subcutaneously in the deltoid region of the upper arm.~Placebo: Injection of 0.65 mL of sterile normal saline"
3925|NCT02958345|O1|Outcome|Zostavax|"Subjects will receive 0.65 mL of Zostavax subcutaneously in the deltoid region of the upper arm.~Zostavax: Vaccination with one dose of Zostavax per Zostavax package insert"
3926|NCT02958345|O2|Outcome|Placebo|"Subjects randomized to placebo will receive an injection of 0.65 mL of sterile normal saline subcutaneously in the deltoid region of the upper arm.~Placebo: Injection of 0.65 mL of sterile normal saline"
3927|NCT02958345|O1|Outcome|Zostavax|"Subjects will receive 0.65 mL of Zostavax subcutaneously in the deltoid region of the upper arm.~Zostavax: Vaccination with one dose of Zostavax per Zostavax package insert"
3928|NCT02958345|E2|Reported Event|Placebo|"Subjects randomized to placebo will receive an injection of 0.65 mL of sterile normal saline subcutaneously in the deltoid region of the upper arm.~Placebo: Injection of 0.65 mL of sterile normal saline"
3929|NCT02958345|E1|Reported Event|Zostavax|"Subjects will receive 0.65 mL of Zostavax subcutaneously in the deltoid region of the upper arm.~Zostavax: Vaccination with one dose of Zostavax per Zostavax package insert"
3930|NCT02956460|B3|Baseline|Total|Total of all reporting groups
3931|NCT02956460|B2|Baseline|Senofilcon A First Then Fanfilcon A|Participants are randomized to wear senofilcon A for two weeks then fanfilcon A
3932|NCT02956460|B1|Baseline|Fanfilcon A First Then Senofilcon A|Participants are randomized to wear fanfilcon A for two weeks then senofilcon A
3933|NCT02956460|P2|Participant Flow|Senofilcon A First Then Fanfilcon A|Participants are randomized to wear senofilcon A for two weeks then fanfilcon A
3934|NCT02956460|P1|Participant Flow|Fanfilcon A First Then Senofilcon A|Participants are randomized to wear fanfilcon A for two weeks then senofilcon A
3935|NCT02956460|O2|Outcome|Senofilcon A|Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
3936|NCT02956460|O1|Outcome|Fanfilcon A|Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.
3937|NCT02956460|O2|Outcome|Senofilcon A|Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
3938|NCT02956460|O1|Outcome|Fanfilcon A|Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.
3939|NCT02956460|O2|Outcome|Senofilcon A|Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
3940|NCT02956460|O1|Outcome|Fanfilcon A|Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.
3941|NCT02956460|O2|Outcome|Senofilcon A|Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
3942|NCT02956460|O1|Outcome|Fanfilcon A|Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.
3943|NCT02956460|O2|Outcome|Senofilcon A|Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
3944|NCT02956460|O1|Outcome|Fanfilcon A|Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.
3945|NCT02956460|O2|Outcome|Senofilcon A|Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
3946|NCT02956460|O1|Outcome|Fanfilcon A|Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.
3947|NCT02956460|O2|Outcome|Senofilcon A|Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
3948|NCT02956460|O1|Outcome|Fanfilcon A|Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.
3949|NCT02956460|O2|Outcome|Senofilcon A|Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
3950|NCT02956460|O1|Outcome|Fanfilcon A|Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.
3951|NCT02956460|O2|Outcome|Senofilcon A|Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
3952|NCT02956460|O1|Outcome|Fanfilcon A|Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.
3953|NCT02956460|O2|Outcome|Senofilcon A|Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
3954|NCT02956460|O1|Outcome|Fanfilcon A|Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.
3955|NCT02956460|O2|Outcome|Senofilcon A|Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
4870|NCT02901054|P1|Participant Flow|Open Label Infusion Ondansetron|The full study cohort (open label, no treatment allocation)
3958|NCT02956460|E1|Reported Event|Fanfilcon A|Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study
3959|NCT02951767|B1|Baseline|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
3960|NCT02951767|P1|Participant Flow|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 milligrams (mg) via intravenous (IV) on Day 1 of 21-day cycles until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria or unmanageable toxicity.
3961|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
3962|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
3963|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
3964|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
3965|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
3966|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
3967|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
3968|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
3969|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
3970|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
3971|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
3972|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
3973|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
3974|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
3975|NCT02951767|E1|Reported Event|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
3976|NCT02951702|B3|Baseline|Total|Total of all reporting groups
3977|NCT02951702|B2|Baseline|Vancomycin|"This arm will receive oral vancomycin 125 mg daily if high risk and determined to be appropriate by an ID physician~Vancomycin Oral: This arm will receive oral vancomycin 125 mg daily if high risk and determined to be appropriate by an ID physician"
3978|NCT02951702|B1|Baseline|Control|"This will be the historical arm that has not received oral vancomycin but match criteria for high risk"
3979|NCT02951702|P2|Participant Flow|Vancomycin|"This arm will receive oral vancomycin 125 mg daily if high risk and determined to be appropriate by an ID physician~Vancomycin Oral: This arm will receive oral vancomycin 125 mg daily if high risk and determined to be appropriate by an ID physician"
3980|NCT02951702|P1|Participant Flow|Control|"This will be the historical arm that has not received oral vancomycin but match criteria for high risk"
4871|NCT02901054|O1|Outcome|Open Label Infusion Ondansetron|The full study cohort (open label, no treatment allocation)
3981|NCT02951702|O2|Outcome|Vancomycin|"This arm will receive oral vancomycin 125 mg daily if high risk and determined to be appropriate by an ID physician~Vancomycin Oral: This arm will receive oral vancomycin 125 mg daily if high risk and determined to be appropriate by an ID physician"
3982|NCT02951702|O1|Outcome|Control|"This will be the historical arm that has not received oral vancomycin but match criteria for high risk"
3983|NCT02951702|O2|Outcome|Vancomycin|"This arm will receive oral vancomycin 125 mg daily if high risk and determined to be appropriate by an ID physician~Vancomycin Oral: This arm will receive oral vancomycin 125 mg daily if high risk and determined to be appropriate by an ID physician"
3984|NCT02951702|O1|Outcome|Control|"This will be the historical arm that has not received oral vancomycin but match criteria for high risk"
3985|NCT02951702|O2|Outcome|Vancomycin|"This arm will receive oral vancomycin 125 mg daily if high risk and determined to be appropriate by an ID physician~Vancomycin Oral: This arm will receive oral vancomycin 125 mg daily if high risk and determined to be appropriate by an ID physician"
3986|NCT02951702|O1|Outcome|Control|"This will be the historical arm that has not received oral vancomycin but match criteria for high risk"
3987|NCT02951702|E2|Reported Event|Vancomycin|"This arm will receive oral vancomycin 125 mg daily if high risk and determined to be appropriate by an ID physician~Vancomycin Oral: This arm will receive oral vancomycin 125 mg daily if high risk and determined to be appropriate by an ID physician"
3988|NCT02951702|E1|Reported Event|Control|"This will be the historical arm that has not received oral vancomycin but match criteria for high risk"
3989|NCT02951312|B5|Baseline|Total|Total of all reporting groups
3990|NCT02951312|B4|Baseline|Placebo|subjects received placebo
3991|NCT02951312|B3|Baseline|200mg Glycopyrrolate Jet|subjects received 200mg Glycopyrrolate
3992|NCT02951312|B2|Baseline|75mg Glycopyrrolate,500mg Glycopyrrolate,1000mg Glycopyrrolate|subjects received 75mg Glycoprrolate, then, 500mg Glycopyrrolate, then 1000mg Glycopyrrolate in part 1 - in part 2 subjects from this group received either 200mg Glycopyrrolate or placebo
3993|NCT02951312|B1|Baseline|25mg Glycopyrrolate, 200mg Gloycopyrrolate|subjects received 25mg Glycopyrrolate then 200mg Glycopyrrolate in part 1- in part 2 subjects from this group either received 200mg Glycopyrrolate or placebo
3994|NCT02951312|P4|Participant Flow|Placebo|Subjects received placebo
3995|NCT02951312|P3|Participant Flow|200mg Glycopyrrolate Jet|subjects received 200mg Glycopyrrolate
3996|NCT02951312|P2|Participant Flow|75mg Glycopyrrolate,500mg Glycopyrrolate,1000mg Glycopyrrolate|subjects received 75mg Glycoprrolate, then, 500mg Glycopyrrolate, then 1000mg Glycopyrrolate in part 1 - in part 2 subjects from this group received either 200mg Glycopyrrolate or placebo
3997|NCT02951312|P1|Participant Flow|25mg Glycopyrrolate, 200mg Gloycopyrrolate|subjects received 25mg Glycopyrrolate then 200mg Glycopyrrolate in part 1- in part 2 subjects from this group either received 200mg Glycopyrrolate or placebo
3998|NCT02951312|O4|Outcome|Glycopyrrolate Inhalation Solution1000mg|"Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily"
3999|NCT02951312|O3|Outcome|Glycopyrrolate Inhalation Solution 500mg|"Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily"
4000|NCT02951312|O2|Outcome|Glycopyrrolate Inhalation Solution 200mg Jet|"Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily"
4001|NCT02951312|O1|Outcome|Glycopyrrolate Inhalation Solution 200mg|"Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily"
4002|NCT02951312|O4|Outcome|Glycopyrrolate Inhalation Solution1000mg|"Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily"
4003|NCT02951312|O3|Outcome|Glycopyrrolate Inhalation Solution 500mg|"Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily"
4004|NCT02951312|O2|Outcome|Glycopyrrolate Inhalation Solution 200mg Jet|"Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily"
4005|NCT02951312|O1|Outcome|Glycopyrrolate Inhalation Solution 200mg|"Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily"
4006|NCT02951312|O4|Outcome|Glycopyrrolate Inhalation Solution1000mg|"Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily"
4007|NCT02951312|O3|Outcome|Glycopyrrolate Inhalation Solution 500mg|"Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily"
4008|NCT02951312|O2|Outcome|Glycopyrrolate Inhalation Solution 200mg Jet|"Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily"
4009|NCT02951312|O1|Outcome|Glycopyrrolate Inhalation Solution 200mg|"Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily"
4010|NCT02951312|O4|Outcome|Glycopyrrolate Inhalation Solution1000mg|"Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily"
4011|NCT02951312|O3|Outcome|Glycopyrrolate Inhalation Solution 500mg|"Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily"
4012|NCT02951312|O2|Outcome|Glycopyrrolate Inhalation Solution 200mg Jet|"Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily"
4276|NCT02945254|O1|Outcome|Background Noise|Overnight sleep study with filtered white noise (NIghtingale (R) Cambridge Sound Management, Waltham, MA)
4013|NCT02951312|O1|Outcome|Glycopyrrolate Inhalation Solution 200mg|"Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily"
4014|NCT02951312|O4|Outcome|Glycopyrrolate Inhalation Solution1000mg|"Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily"
4015|NCT02951312|O3|Outcome|Glycopyrrolate Inhalation Solution 500mg|"Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily"
4016|NCT02951312|O2|Outcome|Glycopyrrolate Inhalation Solution 200mg Jet|"Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily"
4017|NCT02951312|O1|Outcome|Glycopyrrolate Inhalation Solution 200mg|"Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily"
4018|NCT02951312|O7|Outcome|Placebo 0.5 mL|"Placebo 0.5 mL via jet nebulizer, once daily~Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily"
4019|NCT02951312|O6|Outcome|Glycopyrrolate Inhalation Solution1000mg|"Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily"
4020|NCT02951312|O5|Outcome|Glycopyrrolate Inhalation Solution 500mg|"Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily"
4021|NCT02951312|O4|Outcome|Glycopyrrolate Inhalation Solution 200mg Jet|"Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily"
4022|NCT02951312|O3|Outcome|Glycopyrrolate Inhalation Solution 200mg|"Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily"
4023|NCT02951312|O2|Outcome|Glycopyrrolate Inhalation Solution 75mg|"Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily"
4024|NCT02951312|O1|Outcome|Glycopyrrolate Inhalation Solution 25mg|"Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily"
4025|NCT02951312|O7|Outcome|Placebo 0.5 mL|"Placebo 0.5 mL via jet nebulizer, once daily~Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily"
4026|NCT02951312|O6|Outcome|Glycopyrrolate Inhalation Solution1000mg|"Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily"
4027|NCT02951312|O5|Outcome|Glycopyrrolate Inhalation Solution 500mg|"Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily"
4028|NCT02951312|O4|Outcome|Glycopyrrolate Inhalation Solution 200mg Jet|"Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily"
4029|NCT02951312|O3|Outcome|Glycopyrrolate Inhalation Solution 200mg|"Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily"
4030|NCT02951312|O2|Outcome|Glycopyrrolate Inhalation Solution 75mg|"Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily"
4031|NCT02951312|O1|Outcome|Glycopyrrolate Inhalation Solution 25mg|"Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily"
4032|NCT02951312|O7|Outcome|Placebo 0.5 mL|"Placebo 0.5 mL via jet nebulizer, once daily~Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily"
4033|NCT02951312|O6|Outcome|Glycopyrrolate Inhalation Solution1000mg|"Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily"
4034|NCT02951312|O5|Outcome|Glycopyrrolate Inhalation Solution 500mg|"Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily"
4035|NCT02951312|O4|Outcome|Glycopyrrolate Inhalation Solution 200mg Jet|"Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily"
4036|NCT02951312|O3|Outcome|Glycopyrrolate Inhalation Solution 200mg|"Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily"
4037|NCT02951312|O2|Outcome|Glycopyrrolate Inhalation Solution 75mg|"Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily"
4038|NCT02951312|O1|Outcome|Glycopyrrolate Inhalation Solution 25mg|"Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily"
4039|NCT02951312|O7|Outcome|Placebo 0.5 mL|"Placebo 0.5 mL via jet nebulizer, once daily~Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily"
4040|NCT02951312|O6|Outcome|Glycopyrrolate Inhalation Solution1000mg|"Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily"
4041|NCT02951312|O5|Outcome|Glycopyrrolate Inhalation Solution 500mg|"Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily"
4042|NCT02951312|O4|Outcome|Glycopyrrolate Inhalation Solution 200mg Jet|"Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily"
4277|NCT02945254|O2|Outcome|Silence|Overnight sleep study with normal environmental noise
4043|NCT02951312|O3|Outcome|Glycopyrrolate Inhalation Solution 200mg|"Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily"
4044|NCT02951312|O2|Outcome|Glycopyrrolate Inhalation Solution 75mg|"Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily"
4045|NCT02951312|O1|Outcome|Glycopyrrolate Inhalation Solution 25mg|"Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily"
4046|NCT02951312|O7|Outcome|Placebo 0.5 mL|"Placebo 0.5 mL via jet nebulizer, once daily~Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily"
4047|NCT02951312|O6|Outcome|Glycopyrrolate Inhalation Solution1000mg|"Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily"
4048|NCT02951312|O5|Outcome|Glycopyrrolate Inhalation Solution 500mg|"Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily"
4049|NCT02951312|O4|Outcome|Glycopyrrolate Inhalation Solution 200mg Jet|"Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily"
4050|NCT02951312|O3|Outcome|Glycopyrrolate Inhalation Solution 200mg|"Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily"
4051|NCT02951312|O2|Outcome|Glycopyrrolate Inhalation Solution 75mg|"Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily"
4052|NCT02951312|O1|Outcome|Glycopyrrolate Inhalation Solution 25mg|"Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily"
4053|NCT02951312|O7|Outcome|Placebo 0.5 mL|"Placebo 0.5 mL via jet nebulizer, once daily~Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily"
4054|NCT02951312|O6|Outcome|Glycopyrrolate Inhalation Solution1000mg|"Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily"
4055|NCT02951312|O5|Outcome|Glycopyrrolate Inhalation Solution 500mg|"Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily"
4056|NCT02951312|O4|Outcome|Glycopyrrolate Inhalation Solution 200mg Jet|"Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily"
4057|NCT02951312|O3|Outcome|Glycopyrrolate Inhalation Solution 200mg|"Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily"
4058|NCT02951312|O2|Outcome|Glycopyrrolate Inhalation Solution 75mg|"Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily"
4059|NCT02951312|O1|Outcome|Glycopyrrolate Inhalation Solution 25mg|"Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily"
4060|NCT02951312|O7|Outcome|Placebo 0.5 mL|"Placebo 0.5 mL via jet nebulizer, once daily~Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily"
4061|NCT02951312|O6|Outcome|Glycopyrrolate Inhalation Solution1000mg|"Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily"
4062|NCT02951312|O5|Outcome|Glycopyrrolate Inhalation Solution 500mg|"Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily"
4063|NCT02951312|O4|Outcome|Glycopyrrolate Inhalation Solution 200mg Jet|"Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily"
4064|NCT02951312|O3|Outcome|Glycopyrrolate Inhalation Solution 200mg|"Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily"
4065|NCT02951312|O2|Outcome|Glycopyrrolate Inhalation Solution 75mg|"Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily"
4066|NCT02951312|O1|Outcome|Glycopyrrolate Inhalation Solution 25mg|"Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily"
4067|NCT02951312|O7|Outcome|Placebo 0.5 mL|"Placebo 0.5 mL via jet nebulizer, once daily~Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily"
4068|NCT02951312|O6|Outcome|Glycopyrrolate Inhalation Solution1000mg|"Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily"
4069|NCT02951312|O5|Outcome|Glycopyrrolate Inhalation Solution 500mg|"Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily"
4070|NCT02951312|O4|Outcome|Glycopyrrolate Inhalation Solution 200mg Jet|"Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily"
4071|NCT02951312|O3|Outcome|Glycopyrrolate Inhalation Solution 200mg|"Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily"
4072|NCT02951312|O2|Outcome|Glycopyrrolate Inhalation Solution 75mg|"Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily"
4872|NCT02901054|E1|Reported Event|Open Label Infusion Ondansetron|The entire cohort of patients in this open-label study
4073|NCT02951312|O1|Outcome|Glycopyrrolate Inhalation Solution 25mg|"Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily"
4074|NCT02951312|O7|Outcome|Placebo 0.5 mL|"Placebo 0.5 mL via jet nebulizer, once daily~Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily"
4075|NCT02951312|O6|Outcome|Glycopyrrolate Inhalation Solution1000mg|"Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily"
4076|NCT02951312|O5|Outcome|Glycopyrrolate Inhalation Solution 500mg|"Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily"
4077|NCT02951312|O4|Outcome|Glycopyrrolate Inhalation Solution 200mg Jet|"Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily"
4078|NCT02951312|O3|Outcome|Glycopyrrolate Inhalation Solution 200mg|"Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily"
4079|NCT02951312|O2|Outcome|Glycopyrrolate Inhalation Solution 75mg|"Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily"
4080|NCT02951312|O1|Outcome|Glycopyrrolate Inhalation Solution 25mg|"Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily"
4081|NCT02951312|O7|Outcome|Placebo 0.5 mL|"Placebo 0.5 mL via jet nebulizer, once daily~Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily"
4082|NCT02951312|O6|Outcome|Glycopyrrolate Inhalation Solution1000mg|"Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily"
4083|NCT02951312|O5|Outcome|Glycopyrrolate Inhalation Solution 500mg|"Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily"
4084|NCT02951312|O4|Outcome|Glycopyrrolate Inhalation Solution 200mg Jet|"Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily"
4085|NCT02951312|O3|Outcome|Glycopyrrolate Inhalation Solution 200mg|"Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily"
4086|NCT02951312|O2|Outcome|Glycopyrrolate Inhalation Solution 75mg|"Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily"
4087|NCT02951312|O1|Outcome|Glycopyrrolate Inhalation Solution 25mg|"Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily"
4088|NCT02951312|O7|Outcome|Placebo 0.5 mL|"Placebo 0.5 mL via jet nebulizer, once daily~Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily"
4089|NCT02951312|O6|Outcome|Glycopyrrolate Inhalation Solution1000mg|"Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily"
4090|NCT02951312|O5|Outcome|Glycopyrrolate Inhalation Solution 500mg|"Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily"
4091|NCT02951312|O4|Outcome|Glycopyrrolate Inhalation Solution 200mg Jet|"Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily"
4092|NCT02951312|O3|Outcome|Glycopyrrolate Inhalation Solution 200mg|"Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily"
4093|NCT02951312|O2|Outcome|Glycopyrrolate Inhalation Solution 75mg|"Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily"
4094|NCT02951312|O1|Outcome|Glycopyrrolate Inhalation Solution 25mg|"Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily"
4095|NCT02951312|O7|Outcome|Placebo 0.5 mL|"Placebo 0.5 mL via jet nebulizer, once daily~Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily"
4096|NCT02951312|O6|Outcome|Glycopyrrolate Inhalation Solution1000mg|"Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily"
4097|NCT02951312|O5|Outcome|Glycopyrrolate Inhalation Solution 500mg|"Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily"
4098|NCT02951312|O4|Outcome|Glycopyrrolate Inhalation Solution 200mg Jet|"Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily"
4099|NCT02951312|O3|Outcome|Glycopyrrolate Inhalation Solution 200mg|"Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily"
4100|NCT02951312|O2|Outcome|Glycopyrrolate Inhalation Solution 75mg|"Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily"
4101|NCT02951312|O1|Outcome|Glycopyrrolate Inhalation Solution 25mg|"Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily"
4102|NCT02951312|O7|Outcome|Placebo 0.5 mL|"Placebo 0.5 mL via jet nebulizer, once daily~Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily"
4278|NCT02945254|O1|Outcome|Background Noise|Overnight sleep study with filtered white noise (NIghtingale (R) Cambridge Sound Management, Waltham, MA)
4103|NCT02951312|O6|Outcome|Glycopyrrolate Inhalation Solution1000mg|"Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily"
4104|NCT02951312|O5|Outcome|Glycopyrrolate Inhalation Solution 500mg|"Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily"
4105|NCT02951312|O4|Outcome|Glycopyrrolate Inhalation Solution 200mg Jet|"Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily"
4106|NCT02951312|O3|Outcome|Glycopyrrolate Inhalation Solution 200mg|"Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily"
4107|NCT02951312|O2|Outcome|Glycopyrrolate Inhalation Solution 75mg|"Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily"
4108|NCT02951312|O1|Outcome|Glycopyrrolate Inhalation Solution 25mg|"Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily"
4109|NCT02951312|E7|Reported Event|Placebo|"Placebo~Placebo"
4110|NCT02951312|E6|Reported Event|Glycopyrrolate Inhalation Solution1000mg|"Glycopyrrolate Inhalation Solution1000mg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution1000mg via eFlow nebulizer, once daily"
4111|NCT02951312|E5|Reported Event|Glycopyrrolate Inhalation Solution 500μg|"Glycopyrrolate Inhalation Solution 500μg eFlow Nebulizer, once daily~Glycopyrrolate Inhalation Solution 500μg eFlow Nebulizer, once daily"
4112|NCT02951312|E4|Reported Event|Glycopyrrolate Inhalation Solution 200μg Jet Nebulizer,|"Glycopyrrolate Inhalation Solution 200μg Jet Nebulizer ,once daily~Glycopyrrolate Inhalation Solution 200μg Jet Nebulizer, once daily"
4113|NCT02951312|E3|Reported Event|Glycopyrrolate Inhalation Solution 200 μg|"Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily"
4114|NCT02951312|E2|Reported Event|Glycopyrrolate Inhalation Solution75μg|"Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily"
4115|NCT02951312|E1|Reported Event|Glycopyrrolate Inhalation Solution 25 μg|"Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily"
4116|NCT02951273|B1|Baseline|Study of Cerebral Blood Flow|"Patients undergoing oesophageal- or ventricular resection (n=30)~Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.~Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml."
4117|NCT02951273|P1|Participant Flow|Study of Cerebral Blood Flow|"Patients undergoing oesophageal- or ventricular resection (n=30)~Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.~Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml."
4118|NCT02951273|O1|Outcome|Study of Cerebral Blood Flow|"Patients undergoing oesophageal- or ventricular resection (n=30)~Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.~Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml."
4119|NCT02951273|O1|Outcome|Study of Cerebral Blood Flow|"Patients undergoing oesophageal- or ventricular resection (n=30)~Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.~Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml."
4120|NCT02951273|O1|Outcome|Study of Cerebral Blood Flow|"Patients undergoing oesophageal- or ventricular resection (n=30)~Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.~Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml."
4279|NCT02945254|E2|Reported Event|Silence|Overnight sleep study with normal environmental noise
4873|NCT02895347|B3|Baseline|Total|Total of all reporting groups
4121|NCT02951273|O1|Outcome|Study of Cerebral Blood Flow|"Patients undergoing oesophageal- or ventricular resection (n=30)~Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.~Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml."
4122|NCT02951273|O1|Outcome|Study of Cerebral Blood Flow|"Patients undergoing oesophageal- or ventricular resection (n=30)~Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.~Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml."
4123|NCT02951273|O1|Outcome|Study of Cerebral Blood Flow|"Patients undergoing oesophageal- or ventricular resection (n=30)~Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.~Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml."
4124|NCT02951273|O1|Outcome|Study of Cerebral Blood Flow|"Patients undergoing oesophageal- or ventricular resection (n=30)~Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.~Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml."
4125|NCT02951273|O1|Outcome|Study of Cerebral Blood Flow|"Patients undergoing oesophageal- or ventricular resection (n=30)~Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.~Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml."
4126|NCT02951273|O1|Outcome|Study of Cerebral Blood Flow|"Patients undergoing oesophageal- or ventricular resection (n=30)~Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.~Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml."
4127|NCT02951273|O1|Outcome|Study of Cerebral Blood Flow|"Patients undergoing oesophageal- or ventricular resection (n=30)~Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.~Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml."
4128|NCT02951273|O1|Outcome|Study of Cerebral Blood Flow|"Patients undergoing oesophageal- or ventricular resection (n=30)~Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.~Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml."
4156|NCT02948582|O1|Outcome|Glycopyrrolate Inhalation Solution12.5μg|"Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily"
4157|NCT02948582|O6|Outcome|Placebo 0.5mL|"Placebo 0.5mL via e-flow nebulizer, once daily~Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily"
4158|NCT02948582|O5|Outcome|Glycopyrrolate Inhalation Solution 400μg|"Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily"
8329|NCT02743780|E2|Reported Event|MGV354 0.03% Part 1|1 drop in the study eye
4129|NCT02951273|O1|Outcome|Study of Cerebral Blood Flow|"Patients undergoing oesophageal- or ventricular resection (n=30)~Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.~Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml."
4130|NCT02951273|E1|Reported Event|Study of Cerebral Blood Flow|"Patients undergoing oesophageal- or ventricular resection (n=30)~Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.~Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml."
4131|NCT02949141|B1|Baseline|Ultrasound|"All patients will initially get an ultrasound (interpreted by emergency department physician) followed by chest x-ray (read by independent radiologist) and computed tomography (read by radiologist)~Lung Ultrasound: All patients will receive lung ultrasound, chest x-ray and computed tomography.~No adverse events were recorded."
4132|NCT02949141|P1|Participant Flow|All Participants|"All patients will initially get an ultrasound (interpreted by emergency department physician) followed by chest x-ray (read by independent radiologist) and computed tomography (read by radiologist)~Lung Ultrasound: All patients will receive lung ultrasound, chest x-ray and computed tomography."
4133|NCT02949141|O2|Outcome|Chest X-Ray|Chest x-ray diagnosis of pneumonia compared to CT
4134|NCT02949141|O1|Outcome|Ultrasound|Ultrasound Diagnosis of pneumonia compared to CT (Gold Standard)
4135|NCT02949141|E3|Reported Event|Chest Ct|Following US and CXR, all patients received a Chest CT as the gold standard for diagnosis of pneumonia.
4136|NCT02949141|E2|Reported Event|Chest X-ray|Chest x-ray for evaluation of pneumonia.
4137|NCT02949141|E1|Reported Event|Ultrasound|"Lung Ultrasound evaluation for pneumonia.~All patients will receive lung ultrasound, chest x-ray and computed tomography.~No adverse events were recorded."
4138|NCT02948582|B1|Baseline|Total Participants|Intent to treat population same as safety population -not full analysis set
4139|NCT02948582|P6|Participant Flow|Treatment Group 6|subjects received glycopyrrolate 400 mcg, glycopyrrolate 100 mcg, glycopryrrolate 12.5mcg, glycopyrrolate 50mcg, placebo or glycoyrrolate 200mcg
4140|NCT02948582|P5|Participant Flow|Treatment Group 5|subjects received glycopyrrolate 200 mcg, glycopyrrolate 12.5 mcg, placebo, glycopryrrolate 400mcg, placebo, glycopyrrolate 100mcg, or glycoyrrolate 50mcg
4141|NCT02948582|P4|Participant Flow|Treatment Group 4|subjects received glycopyrrolate 100 mcg, glycopyrrolate 200 mcg, glycopryrrolate 400mcg, placebo, glycopyrrolate 50mcg, or glycoyrrolate 12.5mcg
4142|NCT02948582|P3|Participant Flow|Treatment Group 3|subjects received glycopyrrolate 50 mcg, Placebo, glycopyrrolate 200 mcg, glycopryrrolate 100mcg, glycopyrrolate 12.5mcg, or glycoyrrolate 400mcg
4143|NCT02948582|P2|Participant Flow|Treatment Group 2|subjects received glycopyrrolate 12.5 mcg, glycopyrrolate 50 mcg, glycopryrrolate 100mcg, placebo, glycopyrrolate 200mcg, glycoyrrolate 400mcg, or placebo
4144|NCT02948582|P1|Participant Flow|Treatment Group 1|subjects received placebo, glycopyrrolate 400mcg, glycopyrrolate 50 mcg, glycopyrrolate 12.5 mcg, glycoyrrolate 200mcg, or glycopryrrolate 100mcg
4145|NCT02948582|O6|Outcome|Placebo 0.5mL|"Placebo 0.5mL via e-flow nebulizer, once daily~Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily"
4146|NCT02948582|O5|Outcome|Glycopyrrolate Inhalation Solution 400μg|"Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily"
4147|NCT02948582|O4|Outcome|Glycopyrrolate Inhalation Solution 200μg|"Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily"
4148|NCT02948582|O3|Outcome|Glycopyrrolate Inhalation Solution 100μg|"Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily"
4149|NCT02948582|O2|Outcome|Glycopyrrolate Inhalation Solution 50μg|"Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily"
4150|NCT02948582|O1|Outcome|Glycopyrrolate Inhalation Solution12.5μg|"Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily"
4151|NCT02948582|O6|Outcome|Placebo 0.5mL|"Placebo 0.5mL via e-flow nebulizer, once daily~Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily"
4152|NCT02948582|O5|Outcome|Glycopyrrolate Inhalation Solution 400μg|"Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily"
4153|NCT02948582|O4|Outcome|Glycopyrrolate Inhalation Solution 200μg|"Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily"
4154|NCT02948582|O3|Outcome|Glycopyrrolate Inhalation Solution 100μg|"Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily"
4155|NCT02948582|O2|Outcome|Glycopyrrolate Inhalation Solution 50μg|"Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily"
4280|NCT02945254|E1|Reported Event|Background Noise|Overnight sleep study with filtered white noise (NIghtingale (R) Cambridge Sound Management, Waltham, MA)
4159|NCT02948582|O4|Outcome|Glycopyrrolate Inhalation Solution 200μg|"Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily"
4160|NCT02948582|O3|Outcome|Glycopyrrolate Inhalation Solution 100μg|"Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily"
4161|NCT02948582|O2|Outcome|Glycopyrrolate Inhalation Solution 50μg|"Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily"
4162|NCT02948582|O1|Outcome|Glycopyrrolate Inhalation Solution12.5μg|"Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily"
4163|NCT02948582|O6|Outcome|Placebo 0.5mL|"Placebo 0.5mL via e-flow nebulizer, once daily~Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily"
4164|NCT02948582|O5|Outcome|Glycopyrrolate Inhalation Solution 400μg|"Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily"
4165|NCT02948582|O4|Outcome|Glycopyrrolate Inhalation Solution 200μg|"Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily"
4166|NCT02948582|O3|Outcome|Glycopyrrolate Inhalation Solution 100μg|"Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily"
4167|NCT02948582|O2|Outcome|Glycopyrrolate Inhalation Solution 50μg|"Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily"
4168|NCT02948582|O1|Outcome|Glycopyrrolate Inhalation Solution12.5μg|"Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily"
4169|NCT02948582|O6|Outcome|Placebo 0.5mL|"Placebo 0.5mL via e-flow nebulizer, once daily~Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily"
4170|NCT02948582|O5|Outcome|Glycopyrrolate Inhalation Solution 400μg|"Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily"
4171|NCT02948582|O4|Outcome|Glycopyrrolate Inhalation Solution 200μg|"Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily"
4172|NCT02948582|O3|Outcome|Glycopyrrolate Inhalation Solution 100μg|"Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily"
4173|NCT02948582|O2|Outcome|Glycopyrrolate Inhalation Solution 50μg|"Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily"
4174|NCT02948582|O1|Outcome|Glycopyrrolate Inhalation Solution12.5μg|"Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily"
4175|NCT02948582|O5|Outcome|Glycopyrrolate Inhalation Solution 400μg|"Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily"
4176|NCT02948582|O4|Outcome|Glycopyrrolate Inhalation Solution 200μg|"Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily"
4177|NCT02948582|O3|Outcome|Glycopyrrolate Inhalation Solution 100μg|"Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily"
4178|NCT02948582|O2|Outcome|Glycopyrrolate Inhalation Solution 50μg|"Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily"
4179|NCT02948582|O1|Outcome|Glycopyrrolate Inhalation Solution12.5μg|"Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily"
4180|NCT02948582|O5|Outcome|Glycopyrrolate Inhalation Solution 400μg|"Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily"
4181|NCT02948582|O4|Outcome|Glycopyrrolate Inhalation Solution 200μg|"Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily"
4182|NCT02948582|O3|Outcome|Glycopyrrolate Inhalation Solution 100μg|"Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily"
4183|NCT02948582|O2|Outcome|Glycopyrrolate Inhalation Solution 50μg|"Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily"
4184|NCT02948582|O1|Outcome|Glycopyrrolate Inhalation Solution12.5μg|"Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily"
4185|NCT02948582|O5|Outcome|Glycopyrrolate Inhalation Solution 400μg|"Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily"
4186|NCT02948582|O4|Outcome|Glycopyrrolate Inhalation Solution 200μg|"Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily"
4281|NCT02943226|B3|Baseline|Total|Total of all reporting groups
4282|NCT02943226|B2|Baseline|Standard Intravenous Non-fenestrated Catheter|The standard catheter has one hole at the tip for contrast infusion.
4187|NCT02948582|O3|Outcome|Glycopyrrolate Inhalation Solution 100μg|"Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily"
4188|NCT02948582|O2|Outcome|Glycopyrrolate Inhalation Solution 50μg|"Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily"
4189|NCT02948582|O1|Outcome|Glycopyrrolate Inhalation Solution12.5μg|"Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily"
4190|NCT02948582|O5|Outcome|Glycopyrrolate Inhalation Solution 400μg|"Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily"
4191|NCT02948582|O4|Outcome|Glycopyrrolate Inhalation Solution 200μg|"Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily"
4192|NCT02948582|O3|Outcome|Glycopyrrolate Inhalation Solution 100μg|"Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily"
4193|NCT02948582|O2|Outcome|Glycopyrrolate Inhalation Solution 50μg|"Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily"
4194|NCT02948582|O1|Outcome|Glycopyrrolate Inhalation Solution12.5μg|"Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily"
4195|NCT02948582|O5|Outcome|Glycopyrrolate Inhalation Solution 400μg|"Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily"
4196|NCT02948582|O4|Outcome|Glycopyrrolate Inhalation Solution 200μg|"Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily"
4197|NCT02948582|O3|Outcome|Glycopyrrolate Inhalation Solution 100μg|"Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily"
4198|NCT02948582|O2|Outcome|Glycopyrrolate Inhalation Solution 50μg|"Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily"
4199|NCT02948582|O1|Outcome|Glycopyrrolate Inhalation Solution12.5μg|"Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily"
4200|NCT02948582|O6|Outcome|Placebo 0.5mL|"Placebo 0.5mL via e-flow nebulizer, once daily~Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily"
4201|NCT02948582|O5|Outcome|Glycopyrrolate Inhalation Solution 400μg|"Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily"
4202|NCT02948582|O4|Outcome|Glycopyrrolate Inhalation Solution 200μg|"Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily"
4203|NCT02948582|O3|Outcome|Glycopyrrolate Inhalation Solution 100μg|"Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily"
4204|NCT02948582|O2|Outcome|Glycopyrrolate Inhalation Solution 50μg|"Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily"
4205|NCT02948582|O1|Outcome|Glycopyrrolate Inhalation Solution12.5μg|"Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily"
4206|NCT02948582|O6|Outcome|Placebo 0.5mL|"Placebo 0.5mL via e-flow nebulizer, once daily~Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily"
4207|NCT02948582|O5|Outcome|Glycopyrrolate Inhalation Solution 400μg|"Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily"
4208|NCT02948582|O4|Outcome|Glycopyrrolate Inhalation Solution 200μg|"Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily"
4209|NCT02948582|O3|Outcome|Glycopyrrolate Inhalation Solution 100μg|"Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily"
4210|NCT02948582|O2|Outcome|Glycopyrrolate Inhalation Solution 50μg|"Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily"
4211|NCT02948582|O1|Outcome|Glycopyrrolate Inhalation Solution12.5μg|"Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily"
4212|NCT02948582|O6|Outcome|Placebo 0.5mL|"Placebo 0.5mL via e-flow nebulizer, once daily~Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily"
4213|NCT02948582|O5|Outcome|Glycopyrrolate Inhalation Solution 400μg|"Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily"
4214|NCT02948582|O4|Outcome|Glycopyrrolate Inhalation Solution 200μg|"Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily"
4215|NCT02948582|O3|Outcome|Glycopyrrolate Inhalation Solution 100μg|"Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily"
20026|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
4216|NCT02948582|O2|Outcome|Glycopyrrolate Inhalation Solution 50μg|"Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily"
4217|NCT02948582|O1|Outcome|Glycopyrrolate Inhalation Solution12.5μg|"Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily"
4218|NCT02948582|O6|Outcome|Placebo 0.5mL|"Placebo 0.5mL via e-flow nebulizer, once daily~Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily"
4219|NCT02948582|O5|Outcome|Glycopyrrolate Inhalation Solution 400μg|"Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily"
4220|NCT02948582|O4|Outcome|Glycopyrrolate Inhalation Solution 200μg|"Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily"
4221|NCT02948582|O3|Outcome|Glycopyrrolate Inhalation Solution 100μg|"Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily"
4222|NCT02948582|O2|Outcome|Glycopyrrolate Inhalation Solution 50μg|"Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily"
4223|NCT02948582|O1|Outcome|Glycopyrrolate Inhalation Solution12.5μg|"Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily"
4224|NCT02948582|O6|Outcome|Placebo 0.5mL|"Placebo 0.5mL via e-flow nebulizer, once daily~Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily"
4225|NCT02948582|O5|Outcome|Glycopyrrolate Inhalation Solution 400μg|"Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily"
4226|NCT02948582|O4|Outcome|Glycopyrrolate Inhalation Solution 200μg|"Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily"
4227|NCT02948582|O3|Outcome|Glycopyrrolate Inhalation Solution 100μg|"Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily"
4228|NCT02948582|O2|Outcome|Glycopyrrolate Inhalation Solution 50μg|"Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily"
4229|NCT02948582|O1|Outcome|Glycopyrrolate Inhalation Solution12.5μg|"Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily"
4230|NCT02948582|E6|Reported Event|Placebo 0.5mL|"Placebo 0.5mL via e-flow nebulizer, once daily~Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily"
4231|NCT02948582|E5|Reported Event|Glycopyrrolate Inhalation Solution 400μg|"Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily"
4232|NCT02948582|E4|Reported Event|Glycopyrrolate Inhalation Solution 200μg|"Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily"
4233|NCT02948582|E3|Reported Event|Glycopyrrolate Inhalation Solution 100μg|"Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily"
4234|NCT02948582|E2|Reported Event|Glycopyrrolate Inhalation Solution 50μg|"Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily"
4235|NCT02948582|E1|Reported Event|Glycopyrrolate Inhalation Solution12.5μg|"Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily"
4236|NCT02947984|B3|Baseline|Total|Total of all reporting groups
4237|NCT02947984|B2|Baseline|Higher Dose Treatment|"63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.~Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT."
4238|NCT02947984|B1|Baseline|Standard Treatment|"Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Treatment based upon a treatment planning CT."
4239|NCT02947984|P2|Participant Flow|Higher Dose Treatment|"63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.~Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT."
4240|NCT02947984|P1|Participant Flow|Standard Treatment|"Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Treatment based upon a treatment planning CT."
4241|NCT02947984|O2|Outcome|Higher Dose Treatment|"63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.~Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT."
4242|NCT02947984|O1|Outcome|Standard Treatment|"Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Treatment based upon a treatment planning CT."
4243|NCT02947984|O2|Outcome|Higher Dose Treatment|"63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.~Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT."
4244|NCT02947984|O1|Outcome|Standard Treatment|"Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Treatment based upon a treatment planning CT."
4245|NCT02947984|O2|Outcome|Higher Dose Treatment|"63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.~Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT."
4246|NCT02947984|O1|Outcome|Standard Treatment|"Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Treatment based upon a treatment planning CT."
4247|NCT02947984|O2|Outcome|Higher Dose Treatment|"63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.~Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT."
4248|NCT02947984|O1|Outcome|Standard Treatment|"Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Treatment based upon a treatment planning CT."
4249|NCT02947984|E2|Reported Event|Higher Dose Treatment|"63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.~Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT."
4250|NCT02947984|E1|Reported Event|Standard Treatment|"Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Treatment based upon a treatment planning CT."
4251|NCT02947022|B1|Baseline|Calcium DTPA Followed by Zinc DTPA|"Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.~Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.~The same treatment therapy will consist of 3 time-points, approximately 1 m"
4252|NCT02947022|P1|Participant Flow|Calcium DTPA Followed by Zinc DTPA|"Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.~Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.~The same treatment therapy will consist of 3 time-points, approximately 1 m"
4253|NCT02947022|O1|Outcome|Calcium DTPA Followed by Zinc DTPA|"Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.~Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.~The same treatment therapy will consist of 3 time-points, approximately 1 m"
4254|NCT02947022|O1|Outcome|Calcium DTPA Followed by Zinc DTPA|"Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.~Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.~The same treatment therapy will consist of 3 time-points, approximately 1 mo"
4255|NCT02947022|O1|Outcome|Calcium DTPA Followed by Zinc DTPA|"Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.~Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.~The same treatment therapy will consist of 3 time-points, approximately 1 mo"
4272|NCT02945254|B1|Baseline|Background Noise First, Silence Second|Overnight sleep study with filtered white noise (Nightingale (R) device, Cambridge Sound Management, Waltham, MA) on the first study night, then a 1-week non-treatment period, then Overnight sleep study with normal environmental noise
4273|NCT02945254|P2|Participant Flow|Silence First, Background Noise Second|Overnight sleep study with normal environmental noise, then a 1-week non-treatment period, then an Overnight sleep study with filtered white noise (Nightingale (R), Cambridge Sound Management, Waltham, MA)
4256|NCT02947022|O1|Outcome|Calcium DTPA Followed by Zinc DTPA|"Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.~Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.~The same treatment therapy will consist of 3 time-points, approximately 1 mo"
4257|NCT02947022|O1|Outcome|Calcium DTPA Followed by Zinc DTPA|"Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.~Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.~The same treatment therapy will consist of 3 time-points, approximately 1 mo"
4258|NCT02947022|O1|Outcome|Calcium DTPA Followed by Zinc DTPA|"Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.~Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.~The same treatment therapy will consist of 3 time-points, approximately 1 mo"
4259|NCT02947022|O1|Outcome|Calcium DTPA Followed by Zinc DTPA|"Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.~Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.~The same treatment therapy will consist of 3 time-points, approximately 1 mo"
4260|NCT02947022|O1|Outcome|Calcium DTPA Followed by Zinc DTPA|"Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.~Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.~The same treatment therapy will consist of 3 time-points, approximately 1 mo"
4261|NCT02947022|O1|Outcome|Calcium DTPA Followed by Zinc DTPA|"Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.~Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.~The same treatment therapy will consist of 3 time-points, approximately 1 mo"
4262|NCT02947022|O1|Outcome|Calcium DTPA Followed by Zinc DTPA|"Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.~Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.~The same treatment therapy will consist of 3 time-points, approximately 1 mo"
4274|NCT02945254|P1|Participant Flow|Background Noise First, Silence Second|Overnight sleep study with filtered white noise (Nightingale (R) device, Cambridge Sound Management, Waltham, MA) on the first study night, then a 1-week non-treatment period, then Overnight sleep study with normal environmental noise
4275|NCT02945254|O2|Outcome|Silence|Overnight sleep study with normal environmental noise
4263|NCT02947022|O1|Outcome|Calcium DTPA Followed by Zinc DTPA|"Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.~Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.~The same treatment therapy will consist of 3 time-points, approximately 1 mo"
4264|NCT02947022|O1|Outcome|Calcium DTPA Followed by Zinc DTPA|"Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.~Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.~The same treatment therapy will consist of 3 time-points, approximately 1 mo"
4265|NCT02947022|O1|Outcome|Calcium DTPA Followed by Zinc DTPA|"Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.~Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.~The same treatment therapy will consist of 3 time-points, approximately 1"
4266|NCT02947022|O1|Outcome|Calcium DTPA Followed by Zinc DTPA|"Subjects will receive IV administration of Ca-DTPA on day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.~Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.~The same treatment therapy will consist of 3 time-points, approximately 1 mo"
4267|NCT02947022|O1|Outcome|Calcium DTPA Followed by Zinc DTPA|"Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.~Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.~The same treatment therapy will consist of 3 time-points, approximately 1 m"
4268|NCT02947022|O1|Outcome|Calcium DTPA Followed by Zinc DTPA|"Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.~Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.~The same treatment therapy will consist of 3 time-points, approximately 1 mo"
4269|NCT02947022|E1|Reported Event|Calcium DTPA Followed by Zinc DTPA|"Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3.~Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.~The same treatment therapy will consist of 3 time-points, approximately 1 m"
4270|NCT02945254|B3|Baseline|Total|Total of all reporting groups
4271|NCT02945254|B2|Baseline|Silence First, Background Noise Second|Overnight sleep study with normal environmental noise, then a 1-week non-treatment period, then an Overnight sleep study with filtered white noise (Nightingale (R), Cambridge Sound Management, Waltham, MA)
20027|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
4283|NCT02943226|B1|Baseline|Becton Dickinson Nexiva Diffusics System Fenestrated Catheter|Becton Dickinson (BD) Nexiva™ Diffusics™ System uses three laser-cut tear-drop holes located in the catheter tip to stabilize the catheter tip by reducing flow velocities while maintaining flow rates during intravenous contrast administration into the vein.
4284|NCT02943226|P2|Participant Flow|Standard Intravenous Non-fenestrated Catheter|The standard catheter has one hole at the tip for contrast infusion.
4285|NCT02943226|P1|Participant Flow|Becton Dickinson Nexiva Diffusics System Fenestrated Catheter|Becton Dickinson (BD) Nexiva™ Diffusics™ System uses three laser-cut tear-drop holes located in the catheter tip to stabilize the catheter tip by reducing flow velocities while maintaining flow rates during intravenous contrast administration into the vein.
4286|NCT02943226|O2|Outcome|Standard Intravenous Non-fenestrated Catheter|The standard catheter has one hole at the tip for contrast infusion.
4287|NCT02943226|O1|Outcome|Becton Dickinson Nexiva Diffusics System Fenestrated Catheter|Becton Dickinson (BD) Nexiva™ Diffusics™ System uses three laser-cut tear-drop holes located in the catheter tip to stabilize the catheter tip by reducing flow velocities while maintaining flow rates during intravenous contrast administration into the vein.
4288|NCT02943226|O2|Outcome|Standard Intravenous Non-fenestrated Catheter|The standard catheter has one hole at the tip for contrast infusion.
4289|NCT02943226|O1|Outcome|Becton Dickinson Nexiva Diffusics System Fenestrated Catheter|Becton Dickinson (BD) Nexiva™ Diffusics™ System uses three laser-cut tear-drop holes located in the catheter tip to stabilize the catheter tip by reducing flow velocities while maintaining flow rates during intravenous contrast administration into the vein.
4290|NCT02943226|O2|Outcome|Standard Intravenous Non-fenestrated Catheter|The standard catheter has one hole at the tip for contrast infusion.
4291|NCT02943226|O1|Outcome|Becton Dickinson Nexiva Diffusics System Fenestrated Catheter|Becton Dickinson (BD) Nexiva™ Diffusics™ System uses three laser-cut tear-drop holes located in the catheter tip to stabilize the catheter tip by reducing flow velocities while maintaining flow rates during intravenous contrast administration into the vein.
4292|NCT02943226|O2|Outcome|Standard Intravenous Non-fenestrated Catheter|The standard catheter has one hole at the tip for contrast infusion.
4293|NCT02943226|O1|Outcome|Becton Dickinson Nexiva Diffusics System Fenestrated Catheter|Becton Dickinson (BD) Nexiva™ Diffusics™ System uses three laser-cut tear-drop holes located in the catheter tip to stabilize the catheter tip by reducing flow velocities while maintaining flow rates during intravenous contrast administration into the vein.
4294|NCT02943226|O2|Outcome|Standard Intravenous Non-fenestrated Catheter|The standard catheter has one hole at the tip for contrast infusion.
4295|NCT02943226|O1|Outcome|Becton Dickinson Nexiva Diffusics System Fenestrated Catheter|Becton Dickinson (BD) Nexiva™ Diffusics™ System uses three laser-cut tear-drop holes located in the catheter tip to stabilize the catheter tip by reducing flow velocities while maintaining flow rates during intravenous contrast administration into the vein.
4296|NCT02943226|O2|Outcome|Standard Intravenous Non-fenestrated Catheter|The standard catheter has one hole at the tip for contrast infusion.
4297|NCT02943226|O1|Outcome|Becton Dickinson Nexiva Diffusics System Fenestrated Catheter|Becton Dickinson (BD) Nexiva™ Diffusics™ System uses three laser-cut tear-drop holes located in the catheter tip to stabilize the catheter tip by reducing flow velocities while maintaining flow rates during intravenous contrast administration into the vein.
4298|NCT02943226|E2|Reported Event|Standard Intravenous Non-fenestrated Catheter|The standard catheter has one hole at the tip for contrast infusion.
4299|NCT02943226|E1|Reported Event|Becton Dickinson Nexiva Diffusics System Fenestrated Catheter|Becton Dickinson (BD) Nexiva™ Diffusics™ System uses three laser-cut tear-drop holes located in the catheter tip to stabilize the catheter tip by reducing flow velocities while maintaining flow rates during intravenous contrast administration into the vein.
4300|NCT02943213|B1|Baseline|Chlorpromazine 25 mg|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc."
4301|NCT02943213|P1|Participant Flow|Chlorpromazine 25 mg|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc."
4302|NCT02943213|O2|Outcome|Treatment Period 2|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc"
4303|NCT02943213|O1|Outcome|Treatment Period 1|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc."
4304|NCT02943213|O2|Outcome|Treatment Period 2|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc"
4305|NCT02943213|O1|Outcome|Treatment Period 1|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc."
4306|NCT02943213|O2|Outcome|Treatment Period 2|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc"
4307|NCT02943213|O1|Outcome|Treatment Period 1|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc."
4308|NCT02943213|O2|Outcome|Treatment Period 2|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc"
4309|NCT02943213|O1|Outcome|Treatment Period 1|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc."
4372|NCT02939170|O2|Outcome|DT1 MF|Delefilcon A multifocal contact lenses worn bilaterally for 9 hours
4310|NCT02943213|O2|Outcome|Treatment Period 2|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc"
4311|NCT02943213|O1|Outcome|Treatment Period 1|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc."
4312|NCT02943213|O2|Outcome|Treatment Period 2|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc"
4313|NCT02943213|O1|Outcome|Treatment Period 1|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc."
4314|NCT02943213|O2|Outcome|Treatment Period 2|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc"
4315|NCT02943213|O1|Outcome|Treatment Period 1|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc."
4316|NCT02943213|O2|Outcome|Treatment Period 2|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc"
4317|NCT02943213|O1|Outcome|Treatment Period 1|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc."
4318|NCT02943213|O2|Outcome|Treatment Period 2|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc"
4319|NCT02943213|O1|Outcome|Treatment Period 1|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc."
4320|NCT02943213|O2|Outcome|Treatment Period 2|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc"
4321|NCT02943213|O1|Outcome|Treatment Period 1|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc."
4322|NCT02943213|O2|Outcome|Treatment Period 2|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc"
4323|NCT02943213|O1|Outcome|Treatment Period 1|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc."
4324|NCT02943213|O2|Outcome|Treatment Period 2|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc"
4325|NCT02943213|O1|Outcome|Treatment Period 1|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc."
4326|NCT02943213|E2|Reported Event|Treatment Period 2|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc"
4327|NCT02943213|E1|Reported Event|Treatment Period 1|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc."
4328|NCT02941640|B5|Baseline|Total|Total of all reporting groups
4329|NCT02941640|B4|Baseline|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.~Laparoscopic appendectomy: The securing the base of appendix by DS clip.~DS clip"
4330|NCT02941640|B3|Baseline|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.~Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.~Hem-o-lok clip"
4331|NCT02941640|B2|Baseline|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.~Laparoscopic appendectomy: The securing the base of appendix by Stapler.~Stapler"
4332|NCT02941640|B1|Baseline|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.~Laparoscopic appendectomy: The securing the base of appendix by endoloop.~Endoloop"
4333|NCT02941640|P4|Participant Flow|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.~Laparoscopic appendectomy: The securing the base of appendix by DS clip.~DS clip"
4334|NCT02941640|P3|Participant Flow|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.~Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.~Hem-o-lok clip"
4335|NCT02941640|P2|Participant Flow|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.~Laparoscopic appendectomy: The securing the base of appendix by Stapler.~Stapler"
4336|NCT02941640|P1|Participant Flow|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.~Laparoscopic appendectomy: The securing the base of appendix by endoloop.~Endoloop"
4337|NCT02941640|O4|Outcome|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.~Laparoscopic appendectomy: The securing the base of appendix by DS clip.~DS clip"
4373|NCT02939170|O1|Outcome|DT1 MF MM|Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally for 9 hours
4338|NCT02941640|O3|Outcome|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.~Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.~Hem-o-lok clip"
4339|NCT02941640|O2|Outcome|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.~Laparoscopic appendectomy: The securing the base of appendix by Stapler.~Stapler"
4340|NCT02941640|O1|Outcome|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.~Laparoscopic appendectomy: The securing the base of appendix by endoloop.~Endoloop"
4341|NCT02941640|O4|Outcome|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.~Laparoscopic appendectomy: The securing the base of appendix by DS clip.~DS clip"
4342|NCT02941640|O3|Outcome|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.~Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.~Hem-o-lok clip"
4343|NCT02941640|O2|Outcome|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.~Laparoscopic appendectomy: The securing the base of appendix by Stapler.~Stapler"
4344|NCT02941640|O1|Outcome|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.~Laparoscopic appendectomy: The securing the base of appendix by endoloop.~Endoloop"
4345|NCT02941640|O4|Outcome|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.~Laparoscopic appendectomy: The securing the base of appendix by DS clip.~DS clip"
4346|NCT02941640|O3|Outcome|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.~Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.~Hem-o-lok clip"
4347|NCT02941640|O2|Outcome|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.~Laparoscopic appendectomy: The securing the base of appendix by Stapler.~Stapler"
4348|NCT02941640|O1|Outcome|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.~Laparoscopic appendectomy: The securing the base of appendix by endoloop.~Endoloop"
4349|NCT02941640|O4|Outcome|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.~Laparoscopic appendectomy: The securing the base of appendix by DS clip.~DS clip"
4350|NCT02941640|O3|Outcome|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.~Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.~Hem-o-lok clip"
4351|NCT02941640|O2|Outcome|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.~Laparoscopic appendectomy: The securing the base of appendix by Stapler.~Stapler"
4352|NCT02941640|O1|Outcome|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.~Laparoscopic appendectomy: The securing the base of appendix by endoloop.~Endoloop"
4353|NCT02941640|O4|Outcome|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.~Laparoscopic appendectomy: The securing the base of appendix by DS clip.~DS clip"
4354|NCT02941640|O3|Outcome|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.~Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.~Hem-o-lok clip"
4355|NCT02941640|O2|Outcome|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.~Laparoscopic appendectomy: The securing the base of appendix by Stapler.~Stapler"
4356|NCT02941640|O1|Outcome|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.~Laparoscopic appendectomy: The securing the base of appendix by endoloop.~Endoloop"
4357|NCT02941640|O4|Outcome|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.~Laparoscopic appendectomy: The securing the base of appendix by DS clip.~DS clip"
4358|NCT02941640|O3|Outcome|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.~Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.~Hem-o-lok clip"
4359|NCT02941640|O2|Outcome|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.~Laparoscopic appendectomy: The securing the base of appendix by Stapler.~Stapler"
4360|NCT02941640|O1|Outcome|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.~Laparoscopic appendectomy: The securing the base of appendix by endoloop.~Endoloop"
4361|NCT02941640|E4|Reported Event|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.~Laparoscopic appendectomy: The securing the base of appendix by DS clip.~DS clip"
4362|NCT02941640|E3|Reported Event|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.~Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.~Hem-o-lok clip"
4363|NCT02941640|E2|Reported Event|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.~Laparoscopic appendectomy: The securing the base of appendix by Stapler.~Stapler"
4364|NCT02941640|E1|Reported Event|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.~Laparoscopic appendectomy: The securing the base of appendix by endoloop.~Endoloop"
4365|NCT02939170|B3|Baseline|Total|Total of all reporting groups
4366|NCT02939170|B2|Baseline|DT1 MF|Delefilcon A multifocal contact lenses worn bilaterally for 9 hours
4367|NCT02939170|B1|Baseline|DT1 MF MM|Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally for 9 hours
4368|NCT02939170|P2|Participant Flow|DT1 MF|Delefilcon A multifocal contact lenses worn bilaterally for 9 hours
4369|NCT02939170|P1|Participant Flow|DT1 MF MM|Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally (in both eyes) for 9 hours
4370|NCT02939170|O2|Outcome|DT1 MF|Delefilcon A multifocal contact lenses worn bilaterally for 9 hours
4371|NCT02939170|O1|Outcome|DT1 MF MM|Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally for 9 hours
4375|NCT02939170|O1|Outcome|DT1 MF MM|Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally for 9 hours
4376|NCT02939170|E3|Reported Event|DT1 MF|All subjects exposed to delefilcon A multifocal contact lenses
4377|NCT02939170|E2|Reported Event|DT1 MF MM|All subjects exposed to delefilcon A multifocal contact lenses with molded marks
4378|NCT02939170|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to initiation of study treatment
4379|NCT02937870|B1|Baseline|Overall Study Participants|All randomized participants who received all four treatments: test adhesive 1, test adhesive 2, positive control adhesive and no adhesive were included in the baseline assessment.
4380|NCT02937870|P1|Participant Flow|Overall Study|This was a single-center, randomized, controlled, examiner-blind, four-treatment, four-period, crossover study. Participants received a single application of each study treatment, lasting for 12 hours.
4381|NCT02937870|O2|Outcome|Test Adhesive 2|Participants of this arm received topical application of test adhesive 2 to upper denture by site study staff, to clean dry denture fit surface in a pattern consistent with application instructions.
4382|NCT02937870|O1|Outcome|Test Adhesive 1|Participants of this arm received topical application of test adhesive 1 to upper denture by site study staff, to clean dry denture fit surface in a pattern consistent with application instructions.
4383|NCT02937870|O2|Outcome|Positive Control Adhesive|Participants of this arm received topical application of commercial adhesive to upper denture by site study staff, to clean dry denture fit surface in a pattern consistent with application instructions.
4384|NCT02937870|O1|Outcome|Test Adhesive 2|Participants of this arm received topical application of test adhesive 2 to upper denture by site study staff, to clean dry denture fit surface in a pattern consistent with application instructions.
4385|NCT02937870|O2|Outcome|Positive Control Adhesive|Participants of this arm topically applied commercial denture adhesive to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.
4386|NCT02937870|O1|Outcome|Test Adhesive 1|Participants of this arm topically applied test adhesive 1 to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.
4387|NCT02937870|O2|Outcome|No Adhesive|Participants of this arm did not receive any adhesive to apply on upper denture.
4388|NCT02937870|O1|Outcome|Test Adhesive 2|Participants of this arm topically applied test adhesive 2 to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.
4389|NCT02937870|O2|Outcome|No Adhesive|Participants of this arm did not receive any adhesive to apply on upper denture.
4390|NCT02937870|O1|Outcome|Test Adhesive 1|Participants of this arm topically applied test adhesive 1 to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.
4391|NCT02937870|E4|Reported Event|Negative Control|Participants of this arm did not receive any adhesive to apply on upper denture.
4392|NCT02937870|E3|Reported Event|Positive Control Adhesive|Participants of this arm received topical application of commercial adhesive to upper denture by site study staff, to clean dry denture fit surface in a pattern consistent with application instructions.
4393|NCT02937870|E2|Reported Event|Test Adhesive 2|Participants of this arm received topical application of test adhesive 2 to upper denture by site study staff, to clean dry denture fit surface in a pattern consistent with application instructions.
4394|NCT02937870|E1|Reported Event|Test Adhesive 1|Participants of this arm received topical application of test adhesive 1 to upper denture by site study staff, to clean dry denture fit surface in a pattern consistent with application instructions.
4395|NCT02937623|B3|Baseline|Total|Total of all reporting groups
4396|NCT02937623|B2|Baseline|Reference Product: No Treatment/Product|In this arm, participants did not receive any treatment/product.
4397|NCT02937623|B1|Baseline|Test Product: Dissolvable Polymer Strip Containing Novamin|In this arm, participants received an experimental dissolvable polymer strip containing 15 % w/w calcium sodium phosphosilicate (Novamin). One strip was applied per test tooth topically by a suitably qualified member of the site staff. Each participant received 2 strips in total (as two test tooth were assessed per participant).
4398|NCT02937623|P2|Participant Flow|Reference Product: No Treatment/Product|In this arm, participants did not receive any treatment/product.
4399|NCT02937623|P1|Participant Flow|Test Product: Dissolvable Polymer Strip Containing Novamin|In this arm, participants received an experimental dissolvable polymer strip containing 15 % weight/weight (w/w) calcium sodium phosphosilicate (Novamin). One strip was applied per test tooth topically by a suitably qualified member of the site staff. Each participant received 2 strips in total (as two test tooth were assessed per participant).
4400|NCT02937623|O2|Outcome|Reference Product: No Treatment/Product|In this arm, participants did not receive any treatment/product.
4401|NCT02937623|O1|Outcome|Test Product: Dissolvable Polymer Strip Containing Novamin|In this arm, participants received an experimental dissolvable polymer strip containing 15 % w/w calcium sodium phosphosilicate (Novamin). One strip was applied per test tooth topically by a suitably qualified member of the site staff. Each participant received 2 strips in total (as two test tooth were assessed per participant).
4402|NCT02937623|O2|Outcome|Reference Product: No Treatment/Product|In this arm, participants did not receive any treatment/product.
4403|NCT02937623|O1|Outcome|Test Product: Dissolvable Polymer Strip Containing Novamin|In this arm, participants received an experimental dissolvable polymer strip containing 15 % w/w calcium sodium phosphosilicate (Novamin). One strip was applied per test tooth topically by a suitably qualified member of the site staff. Each participant received 2 strips in total (as two test tooth were assessed per participant).
4404|NCT02937623|O2|Outcome|Reference Product: No Treatment/Product|In this arm, participants did not receive any treatment/product.
4405|NCT02937623|O1|Outcome|Test Product: Dissolvable Polymer Strip Containing Novamin|In this arm, participants received an experimental dissolvable polymer strip containing 15 % w/w calcium sodium phosphosilicate (Novamin). One strip was applied per test tooth topically by a suitably qualified member of the site staff. Each participant received 2 strips in total (as two test tooth were assessed per participant).
4406|NCT02937623|O2|Outcome|Reference Product: No Treatment/Product|In this arm, participants did not receive any treatment/product.
8330|NCT02743780|E1|Reported Event|MGV354 0.01% Part 1|1 drop in the study eye
4407|NCT02937623|O1|Outcome|Test Product: Dissolvable Polymer Strip Containing Novamin|In this arm, participants received an experimental dissolvable polymer strip containing 15 % w/w calcium sodium phosphosilicate (Novamin). One strip was applied per test tooth topically by a suitably qualified member of the site staff. Each participant received 2 strips in total (as two test tooth were assessed per participant).
4408|NCT02937623|E2|Reported Event|Reference Product: No Treatment/Product|In this arm, participants did not receive any treatment/product.
4409|NCT02937623|E1|Reported Event|Test Product: Dissolvable Polymer Strip Containing Novamin|In this arm, participants received an experimental dissolvable polymer strip containing 15 % w/w calcium sodium phosphosilicate (Novamin). One strip was applied per test tooth topically by a suitably qualified member of the site staff. Each participant received 2 strips in total (as two test tooth were assessed per participant).
4410|NCT02937506|B3|Baseline|Total|Total of all reporting groups
4411|NCT02937506|B2|Baseline|Fentanyl Plus Midazolam Only|"Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy.~Fentanyl Plus Midazolam: The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy."
4412|NCT02937506|B1|Baseline|Propofol|"Patients in the treatment arm will be given propofol only when having a colonoscopy.~Propofol: The intervention is to use propofol as anesthesia during a colonoscopy."
4413|NCT02937506|P2|Participant Flow|Fentanyl Plus Midazolam Only|"Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy.~Fentanyl Plus Midazolam: The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy."
4414|NCT02937506|P1|Participant Flow|Propofol|"Patients in the treatment arm will be given propofol only when having a colonoscopy.~Propofol: The intervention is to use propofol as anesthesia during a colonoscopy."
4415|NCT02937506|O2|Outcome|Fentanyl Plus Midazolam Only|"Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy.~Fentanyl Plus Midazolam: The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy."
4416|NCT02937506|O1|Outcome|Propofol|"Patients in the treatment arm will be given propofol only when having a colonoscopy.~Propofol: The intervention is to use propofol as anesthesia during a colonoscopy."
4417|NCT02937506|E2|Reported Event|Fentanyl Plus Midazolam Only|"Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy.~Fentanyl Plus Midazolam: The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy."
4418|NCT02937506|E1|Reported Event|Propofol|"Patients in the treatment arm will be given propofol only when having a colonoscopy.~Propofol: The intervention is to use propofol as anesthesia during a colonoscopy."
4419|NCT02934347|B3|Baseline|Total|Total of all reporting groups
4420|NCT02934347|B2|Baseline|Back-up|A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
4421|NCT02934347|B1|Baseline|Supine|A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
4422|NCT02934347|P2|Participant Flow|Back-up|A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
4423|NCT02934347|P1|Participant Flow|Supine|A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
4424|NCT02934347|O2|Outcome|Back-up|A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
4425|NCT02934347|O1|Outcome|Supine|A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
4426|NCT02934347|O2|Outcome|Back-up|A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
4427|NCT02934347|O1|Outcome|Supine|A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
4428|NCT02934347|O2|Outcome|Back-up|A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
4429|NCT02934347|O1|Outcome|Supine|A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
4430|NCT02934347|O2|Outcome|Back-up|A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
4431|NCT02934347|O1|Outcome|Supine|A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
4432|NCT02934347|E2|Reported Event|Back-up|A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
4433|NCT02934347|E1|Reported Event|Supine|A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
4434|NCT02933476|B1|Baseline|Vibrotactile Stimulation Treatment|"All patients will receive the vibrotactile stimulation treatment. No deception will be used.~Vibrotactile Stimulation: The tactile stimulator is being tested for an off-label use as treatment for Parkinson's disease. There are nodes embedded into the fingertips of gloves that gently vibrate in an alternating pattern. The sensation is similar to the feeling of a phone vibrating. This is a non-significant risk device."
4435|NCT02933476|P1|Participant Flow|Vibrotactile Stimulation Treatment|"All patients will receive the vibrotactile stimulation treatment. No deception will be used.~Vibrotactile Stimulation: The tactile stimulator is being tested for an off-label use as treatment for Parkinson's disease. There are nodes embedded into the fingertips of gloves that gently vibrate in an alternating pattern. The sensation is similar to the feeling of a phone vibrating. This is a non-significant risk device."
4436|NCT02933476|O1|Outcome|Vibrotactile Stimulation Treatment|"All patients will receive the vibrotactile stimulation treatment. No deception will be used.~Vibrotactile Stimulation: The tactile stimulator is being tested for an off-label use as treatment for Parkinson's disease. There are nodes embedded into the fingertips of gloves that gently vibrate in an alternating pattern. The sensation is similar to the feeling of a phone vibrating. This is a non-significant risk device."
4437|NCT02933476|O1|Outcome|Vibrotactile Stimulation Treatment|"All patients will receive the vibrotactile stimulation treatment. No deception will be used.~Vibrotactile Stimulation: The tactile stimulator is being tested for an off-label use as treatment for Parkinson's disease. There are nodes embedded into the fingertips of gloves that gently vibrate in an alternating pattern. The sensation is similar to the feeling of a phone vibrating. This is a non-significant risk device."
4438|NCT02933476|O1|Outcome|Vibrotactile Stimulation Treatment|"All patients will receive the vibrotactile stimulation treatment. No deception will be used.~Vibrotactile Stimulation: The tactile stimulator is being tested for an off-label use as treatment for Parkinson's disease. There are nodes embedded into the fingertips of gloves that gently vibrate in an alternating pattern. The sensation is similar to the feeling of a phone vibrating. This is a non-significant risk device."
4439|NCT02933476|O1|Outcome|Vibrotactile Stimulation Treatment|"All patients will receive the vibrotactile stimulation treatment. No deception will be used.~Vibrotactile Stimulation: The tactile stimulator is being tested for an off-label use as treatment for Parkinson's disease. There are nodes embedded into the fingertips of gloves that gently vibrate in an alternating pattern. The sensation is similar to the feeling of a phone vibrating. This is a non-significant risk device."
4440|NCT02933476|E1|Reported Event|Vibrotactile Stimulation Treatment|"All patients will receive the vibrotactile stimulation treatment. No deception will be used.~Vibrotactile Stimulation: The tactile stimulator is being tested for an off-label use as treatment for Parkinson's disease. There are nodes embedded into the fingertips of gloves that gently vibrate in an alternating pattern. The sensation is similar to the feeling of a phone vibrating. This is a non-significant risk device."
4441|NCT02928380|B1|Baseline|Overall Participants|All the participants received all three treatments (reference denture adhesive, test denture adhesive and no adhesive) in the study period 1, 2, and 3 according to the randomization sequence. Each treatment period was separated by washout period of 2-7 days. All randomized participants were included for baseline evaluation.
4442|NCT02928380|P6|Participant Flow|No Adhesive/Test Denture Adhesive/Reference Denture Adhesive|Participants received no adhesive, test denture adhesive and reference denture adhesive by site staff in treatment periods 1, 2, 3 respectively, to their dentures which were placed in their mouth. A single application of each adhesive was applied. The three treatment periods were separated by a washout period of 2-7 days.
4443|NCT02928380|P5|Participant Flow|No Adhesive/Reference Denture Adhesive/Test Denture Adhesive|Participants received no adhesive, reference denture adhesive and test denture adhesive by site staff in treatment periods 1, 2, 3 respectively, to their dentures which were placed in their mouth. A single application of each adhesive was applied. The three treatment periods were separated by a washout period of 2-7 days.
4444|NCT02928380|P4|Participant Flow|Test Denture Adhesive/No Adhesive/Reference Denture Adhesive|Participants received test denture adhesive, no adhesive and reference denture adhesive by site staff in treatment periods 1, 2, 3 respectively, to their dentures which were placed in their mouth. A single application of each adhesive was applied. The three treatment periods were separated by a washout period of 2-7 days.
4445|NCT02928380|P3|Participant Flow|Test Denture Adhesive/Reference Denture Adhesive/No Adhesive|Participants received test denture adhesive, reference denture adhesive and no adhesive by site staff in treatment periods 1, 2, 3 respectively, to their dentures which were placed in their mouth. A single application of each adhesive was applied. The three treatment periods were separated by a washout period of 2-7 days.
4446|NCT02928380|P2|Participant Flow|Reference Denture Adhesive/No Adhesive/Test Denture Adhesive|Participants received reference denture adhesive, no adhesive and test denture adhesive by site staff in treatment periods 1, 2, 3 respectively, to their dentures which were placed in their mouth. A single application of each adhesive was applied. The three treatment periods were separated by a washout period of 2-7 days.
4447|NCT02928380|P1|Participant Flow|Reference Denture Adhesive/Test Denture Adhesive/No Adhesive|Participants received reference denture adhesive, test denture adhesive and no adhesive by site staff in treatment periods 1, 2, 3 respectively, to their dentures which were placed in their mouth. A single application of each adhesive was applied. The three treatment periods were separated by a washout period of 2-7 days.
4448|NCT02928380|O3|Outcome|No Adhesive (Negative Control)|Participants did not receive any denture adhesive by site staff in this treatment arm.
4449|NCT02928380|O2|Outcome|Test Denture Adhesive|Participants received test denture adhesive by site staff as 3 continuous strips those were applied to upper denture and one continuous strip that was applied to the lower denture, which were placed in the mouth.
4450|NCT02928380|O1|Outcome|Reference Denture Adhesive|Participants received reference denture adhesive by site staff as a 3 dabs those were applied to upper denture and 2 dabs those were applied to lower denture which were placed in the mouth.
4451|NCT02928380|O3|Outcome|No Adhesive (Negative Control)|Participants did not receive any denture adhesive by site staff in this treatment arm.
4452|NCT02928380|O2|Outcome|Test Denture Adhesive|Participants received test denture adhesive by site staff as 3 continuous strips those were applied to upper denture and one continuous strip that was applied to the lower denture, which were placed in the mouth.
4453|NCT02928380|O1|Outcome|Reference Denture Adhesive|Participants received reference denture adhesive by site staff as a 3 dabs those were applied to upper denture and 2 dabs those were applied to lower denture which were placed in the mouth.
4454|NCT02928380|O3|Outcome|No Adhesive (Negative Control)|Participants did not receive any denture adhesive by site staff in this treatment arm.
4455|NCT02928380|O2|Outcome|Test Denture Adhesive|Participants received test denture adhesive by site staff as 3 continuous strips those were applied to upper denture and one continuous strip that was applied to the lower denture, which were placed in the mouth.
4456|NCT02928380|O1|Outcome|Reference Denture Adhesive|Participants received reference denture adhesive by site staff as a 3 dabs those were applied to upper denture and 2 dabs those were applied to lower denture which were placed in the mouth.
8331|NCT02743702|B3|Baseline|Total|Total of all reporting groups
4457|NCT02928380|O2|Outcome|Reference Denture Adhesive|Participants received reference denture adhesive by site staff as a 3 dabs those were applied to upper denture and 2 dabs those were applied to lower denture which were placed in the mouth.
4458|NCT02928380|O1|Outcome|Test Denture Adhesive|Participants received test denture adhesive by site staff as 3 continuous strips those were applied to upper denture and one continuous strip that was applied to the lower denture, which were placed in the mouth.
4459|NCT02928380|O2|Outcome|No Adhesive (Negative Control)|Participants did not receive any denture adhesive by site staff in this treatment arm.
4460|NCT02928380|O1|Outcome|Test Denture Adhesive|Participants received test denture adhesive by site staff as 3 continuous strips those were applied to upper denture and one continuous strip that was applied to the lower denture, which were placed in the mouth.
4461|NCT02928380|O2|Outcome|No Adhesive (Negative Control)|Participants did not receive any denture adhesive by site staff in this treatment arm.
4462|NCT02928380|O1|Outcome|Reference Denture Adhesive|Participants received reference denture adhesive by site staff as a 3 dabs those were applied to upper denture and 2 dabs those were applied to lower denture which were placed in the mouth.
4463|NCT02928380|E3|Reported Event|No Adhesive (Negative Control)|Participants did not receive any denture adhesive by site staff in this treatment arm.
4464|NCT02928380|E2|Reported Event|Test Denture Adhesive|Participants received test denture adhesive by site staff as 3 continuous strips those were applied to upper denture and one continuous strip that was applied to the lower denture, which were placed in the mouth.
4465|NCT02928380|E1|Reported Event|Reference Denture Adhesive|Participants received reference denture adhesive by site staff as a 3 dabs those were applied to upper denture and 2 dabs those were applied to lower denture which were placed in the mouth.
4466|NCT02923245|B3|Baseline|Total|Total of all reporting groups
4467|NCT02923245|B2|Baseline|Usual Care|Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until the patient endorses sensation of maximum bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.
4468|NCT02923245|B1|Baseline|POCUS|"Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until a full bladder is visualized by the ED physician on POCUS or the patient endorses maximal bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.~point-of-care ultrasound"
4469|NCT02923245|P2|Participant Flow|Usual Care (UC)|Patients will be given consecutive intravenous (IV) fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until the patient endorses sensation of maximum bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.
4470|NCT02923245|P1|Participant Flow|Point-of-care Ultrasound (POCUS)|"Patients will be given consecutive intravenous (IV) fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until a full bladder is visualized by the emergency department (ED) physician on POCUS or the patient endorses maximal bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.~point-of-care ultrasound"
4471|NCT02923245|O1|Outcome|Bladder POCUS Images|all saved POCUS images were de-identified and retrospectively reviewed by the study site’s Director of Pediatric Emergency Ultrasound. The reviewer, blinded to the original assessment of the study sonographer, rated each image as small, medium, large, or unidentifiable.
4472|NCT02923245|O2|Outcome|Usual Care|Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until the patient endorses sensation of maximum bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.
4473|NCT02923245|O1|Outcome|POCUS|"Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until a full bladder is visualized by the ED physician on POCUS or the patient endorses maximal bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.~point-of-care ultrasound"
4474|NCT02923245|O2|Outcome|Usual Care|Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until the patient endorses sensation of maximum bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.
4475|NCT02923245|O1|Outcome|POCUS|"Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until a full bladder is visualized by the ED physician on POCUS or the patient endorses maximal bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.~point-of-care ultrasound"
4476|NCT02923245|O2|Outcome|Usual Care|Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until the patient endorses sensation of maximum bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.
4477|NCT02923245|O1|Outcome|POCUS|"Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until a full bladder is visualized by the ED physician on POCUS or the patient endorses maximal bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.~point-of-care ultrasound"
4593|NCT02920957|O3|Outcome|Comfilcon A After 1 Month|Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.
4478|NCT02923245|O2|Outcome|Usual Care|Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until the patient endorses sensation of maximum bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.
4479|NCT02923245|O1|Outcome|POCUS|"Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until a full bladder is visualized by the ED physician on POCUS or the patient endorses maximal bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.~point-of-care ultrasound"
4480|NCT02923245|O2|Outcome|Usual Care|Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until the patient endorses sensation of maximum bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.
4481|NCT02923245|O1|Outcome|POCUS|"Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until a full bladder is visualized by the ED physician on POCUS or the patient endorses maximal bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.~point-of-care ultrasound"
4482|NCT02923245|O2|Outcome|Usual Care|Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until the patient endorses sensation of maximum bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.
4483|NCT02923245|O1|Outcome|POCUS|"Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until a full bladder is visualized by the ED physician on POCUS or the patient endorses maximal bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.~point-of-care ultrasound"
4484|NCT02923245|E2|Reported Event|Usual Care|Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until the patient endorses sensation of maximum bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.
4485|NCT02923245|E1|Reported Event|POCUS|"Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until a full bladder is visualized by the ED physician on POCUS or the patient endorses maximal bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.~point-of-care ultrasound"
4486|NCT02922868|B3|Baseline|Total|Total of all reporting groups
4487|NCT02922868|B2|Baseline|Olympus Visera Elite OTV-S190 Scope|"Olympus HD Flexible Cysto-Nephro Videoscope (CYF-VH) with Olympus Visera Elite Platform, including OTV-S190 Video Processor CLV-S190 Xenon Light Source. Olympus Visera Elite OTV-S190 Scope.~Olympus Visera Elite OTV-S190 Scope: Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope"
4488|NCT02922868|B1|Baseline|EndoSheath CST-5000 Scope|"Cogentix Medical CST-5000 Flexible Video Cystoscope with Slide-On® EndoSheath® Technology. EndoSheath CST-5000 Scope.~EndoSheath CST-5000 Scope: Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope."
4489|NCT02922868|P2|Participant Flow|Olympus Visera Elite OTV-S190 Scope|"Olympus HD Flexible Cysto-Nephro Videoscope (CYF-VH) with Olympus Visera Elite Platform, including OTV-S190 Video Processor CLV-S190 Xenon Light Source. Olympus Visera Elite OTV-S190 Scope.~Olympus Visera Elite OTV-S190 Scope: Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope"
4490|NCT02922868|P1|Participant Flow|EndoSheath CST-5000 Scope|"Cogentix Medical CST-5000 Flexible Video Cystoscope with Slide-On® EndoSheath® Technology. EndoSheath CST-5000 Scope.~EndoSheath CST-5000 Scope: Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope."
4491|NCT02922868|O2|Outcome|Olympus Visera Elite OTV-S190 Scope|"Olympus HD Flexible Cysto-Nephro Videoscope (CYF-VH) with Olympus Visera Elite Platform, including OTV-S190 Video Processor CLV-S190 Xenon Light Source. Olympus Visera Elite OTV-S190 Scope.~Olympus Visera Elite OTV-S190 Scope: Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope"
4492|NCT02922868|O1|Outcome|EndoSheath CST-5000 Scope|"Cogentix Medical CST-5000 Flexible Video Cystoscope with Slide-On® EndoSheath® Technology. EndoSheath CST-5000 Scope.~EndoSheath CST-5000 Scope: Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope."
4493|NCT02922868|O2|Outcome|Olympus Visera Elite OTV-S190 Scope|"Olympus HD Flexible Cysto-Nephro Videoscope (CYF-VH) with Olympus Visera Elite Platform, including OTV-S190 Video Processor CLV-S190 Xenon Light Source. Olympus Visera Elite OTV-S190 Scope.~Olympus Visera Elite OTV-S190 Scope: Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope"
4494|NCT02922868|O1|Outcome|EndoSheath CST-5000 Scope|"Cogentix Medical CST-5000 Flexible Video Cystoscope with Slide-On® EndoSheath® Technology. EndoSheath CST-5000 Scope.~EndoSheath CST-5000 Scope: Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope."
4495|NCT02922868|O2|Outcome|Olympus Visera Elite OTV-S190 Scope|"Olympus HD Flexible Cysto-Nephro Videoscope (CYF-VH) with Olympus Visera Elite Platform, including OTV-S190 Video Processor CLV-S190 Xenon Light Source. Olympus Visera Elite OTV-S190 Scope.~Olympus Visera Elite OTV-S190 Scope: Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope"
4496|NCT02922868|O1|Outcome|EndoSheath CST-5000 Scope|"Cogentix Medical CST-5000 Flexible Video Cystoscope with Slide-On® EndoSheath® Technology. EndoSheath CST-5000 Scope.~EndoSheath CST-5000 Scope: Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope."
4528|NCT02921412|O1|Outcome|Enfilcon A Toric (Baseline)|All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
20028|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
4497|NCT02922868|O2|Outcome|Olympus Visera Elite OTV-S190 Scope|"Olympus HD Flexible Cysto-Nephro Videoscope (CYF-VH) with Olympus Visera Elite Platform, including OTV-S190 Video Processor CLV-S190 Xenon Light Source. Olympus Visera Elite OTV-S190 Scope.~Olympus Visera Elite OTV-S190 Scope: Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope"
4498|NCT02922868|O1|Outcome|EndoSheath CST-5000 Scope|"Cogentix Medical CST-5000 Flexible Video Cystoscope with Slide-On® EndoSheath® Technology. EndoSheath CST-5000 Scope.~EndoSheath CST-5000 Scope: Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope."
4499|NCT02922868|O2|Outcome|Olympus Visera Elite OTV-S190 Scope|"Olympus HD Flexible Cysto-Nephro Videoscope (CYF-VH) with Olympus Visera Elite Platform, including OTV-S190 Video Processor CLV-S190 Xenon Light Source. Olympus Visera Elite OTV-S190 Scope.~Olympus Visera Elite OTV-S190 Scope: Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope"
4500|NCT02922868|O1|Outcome|EndoSheath CST-5000 Scope|"Cogentix Medical CST-5000 Flexible Video Cystoscope with Slide-On® EndoSheath® Technology. EndoSheath CST-5000 Scope.~EndoSheath CST-5000 Scope: Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope."
4501|NCT02922868|O2|Outcome|Olympus Visera Elite OTV-S190 Scope|"Olympus HD Flexible Cysto-Nephro Videoscope (CYF-VH) with Olympus Visera Elite Platform, including OTV-S190 Video Processor CLV-S190 Xenon Light Source. Olympus Visera Elite OTV-S190 Scope.~Olympus Visera Elite OTV-S190 Scope: Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope"
4502|NCT02922868|O1|Outcome|EndoSheath CST-5000 Scope|"Cogentix Medical CST-5000 Flexible Video Cystoscope with Slide-On® EndoSheath® Technology. EndoSheath CST-5000 Scope.~EndoSheath CST-5000 Scope: Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope."
4503|NCT02922868|O2|Outcome|Olympus Visera Elite OTV-S190 Scope|"Olympus HD Flexible Cysto-Nephro Videoscope (CYF-VH) with Olympus Visera Elite Platform, including OTV-S190 Video Processor CLV-S190 Xenon Light Source. Olympus Visera Elite OTV-S190 Scope.~Olympus Visera Elite OTV-S190 Scope: Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope"
4504|NCT02922868|O1|Outcome|EndoSheath CST-5000 Scope|"Cogentix Medical CST-5000 Flexible Video Cystoscope with Slide-On® EndoSheath® Technology. EndoSheath CST-5000 Scope.~EndoSheath CST-5000 Scope: Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope."
4505|NCT02922868|E2|Reported Event|Olympus Visera Elite OTV-S190 Scope|"Olympus HD Flexible Cysto-Nephro Videoscope (CYF-VH) with Olympus Visera Elite Platform, including OTV-S190 Video Processor CLV-S190 Xenon Light Source. Olympus Visera Elite OTV-S190 Scope.~Olympus Visera Elite OTV-S190 Scope: Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope"
4506|NCT02922868|E1|Reported Event|EndoSheath CST-5000 Scope|"Cogentix Medical CST-5000 Flexible Video Cystoscope with Slide-On® EndoSheath® Technology. EndoSheath CST-5000 Scope.~EndoSheath CST-5000 Scope: Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope."
4507|NCT02921412|B1|Baseline|Enfilcon A Toric / Fanfilcon A Toric|All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
4508|NCT02921412|P1|Participant Flow|All Participants (Enfilcon A Toric / Fanfilcon A Toric Lenses)|All participants wore enfilcon A toric lens (habitual) and then wore fanfilcon A toric lenses for 1 month.
4509|NCT02921412|O4|Outcome|Fanfilcon A Toric (1 Month)|All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
4510|NCT02921412|O3|Outcome|Fanfilcon A Toric (2 Weeks)|All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
4511|NCT02921412|O2|Outcome|Fanfilcon A Toric (Dispense)|All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
4512|NCT02921412|O1|Outcome|Enfilcon A Toric (Baseline)|All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
4513|NCT02921412|O4|Outcome|Fanfilcon A Toric (1 Month)|All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
4514|NCT02921412|O3|Outcome|Fanfilcon A Toric (2 Weeks)|All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
4515|NCT02921412|O2|Outcome|Fanfilcon A Toric (Dispense)|All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
4516|NCT02921412|O1|Outcome|Enfilcon A Toric (Baseline)|All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
4517|NCT02921412|O4|Outcome|Fanfilcon A Toric (1 Month)|All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
4518|NCT02921412|O3|Outcome|Fanfilcon A Toric (2 Weeks)|All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
4519|NCT02921412|O2|Outcome|Fanfilcon A Toric (Dispense)|All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
4520|NCT02921412|O1|Outcome|Enfilcon A Toric (Baseline)|All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
4521|NCT02921412|O4|Outcome|Fanfilcon A Toric (1 Month)|All participants wear enfilcon A toric lens (for 1 month) and then refitted with fanfilcon A toric lenses at baseline visit.
4522|NCT02921412|O3|Outcome|Fanfilcon A Toric (2 Weeks)|All participants wear enfilcon A toric lens (for 1 month) and then refitted with fanfilcon A toric lenses at baseline visit.
4523|NCT02921412|O2|Outcome|Fanfilcon A Toric (Dispense)|All participants wear enfilcon A toric lens (for 1 month) and then refitted with fanfilcon A toric lenses at baseline visit.
4524|NCT02921412|O1|Outcome|Enfilcon A Toric (Baseline)|All participants wear enfilcon A toric lens (for 1 month) and then refitted with fanfilcon A toric lenses at baseline visit.
4525|NCT02921412|O4|Outcome|Fanfilcon A Toric (1 Month)|All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
4526|NCT02921412|O3|Outcome|Fanfilcon A Toric (2 Weeks)|All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
4527|NCT02921412|O2|Outcome|Fanfilcon A Toric (Dispense)|All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
4529|NCT02921412|E1|Reported Event|All Participants (Enfilcon A Toric / Fanfilcon A Toric Lenses)|All participants wore enfilcon A toric lenses (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
4530|NCT02921386|B1|Baseline|Oral Testosterone Undecanoate|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate"
4531|NCT02921386|P1|Participant Flow|Oral Testosterone Undecanoate 237 mg BID|Subjects complete Sequence A-E. Amount of Fat Varies by Sequence. Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to breakfast and immediately prior to dinner.
4532|NCT02921386|O5|Outcome|Breakfast E - High Fat|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to high fat breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods"
4533|NCT02921386|O4|Outcome|Breakfast D - 45 g Fat|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 45 g fat breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods"
4534|NCT02921386|O3|Outcome|Breakfast C - 30 g Fat|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 30 g fat breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods"
4535|NCT02921386|O2|Outcome|Breakfast B - 15 g Fat|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 15 g fat breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods"
4536|NCT02921386|O1|Outcome|Breakfast A - Fasting|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to Fasting at breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods"
4537|NCT02921386|O5|Outcome|Breakfast E - High Fat|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to high fat breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods"
4538|NCT02921386|O4|Outcome|Breakfast D - 45 g Fat|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 45 g fat breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods"
4539|NCT02921386|O3|Outcome|Breakfast C - 30 g Fat|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 30 g fat breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods"
4540|NCT02921386|O2|Outcome|Breakfast B - 15 g Fat|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 15 g fat breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods"
4541|NCT02921386|O1|Outcome|Breakfast A - Fasting|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to Fasting at breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods"
4542|NCT02921386|O5|Outcome|Breakfast E - High Fat|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to high fat breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods"
4543|NCT02921386|O4|Outcome|Breakfast D - 45 g Fat|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 45 g fat breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods"
4544|NCT02921386|O3|Outcome|Breakfast C - 30 g Fat|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 30 g fat breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods"
4545|NCT02921386|O2|Outcome|Breakfast B - 15 g Fat|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 15 g fat breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods"
4546|NCT02921386|O1|Outcome|Breakfast A - Fasting|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to Fasting at breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods"
4547|NCT02921386|O5|Outcome|Breakfast E - High Fat|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to high fat breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods"
4548|NCT02921386|O4|Outcome|Breakfast D - 45 g Fat|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 45 g fat breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods"
4549|NCT02921386|O3|Outcome|Breakfast C - 30 g Fat|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 30 g fat breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods"
4592|NCT02920957|O4|Outcome|Senofilcon C at Dispense|Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.
4550|NCT02921386|O2|Outcome|Breakfast B - 15 g Fat|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 15 g fat breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods"
4551|NCT02921386|O1|Outcome|Breakfast A - Fasting|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to Fasting at breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods"
4552|NCT02921386|E1|Reported Event|Oral Testosterone Undecanoate 237 mg BID|Subjects will self-administer 237 mg oral TU BID for a 14 day Run-in Phase, followed by 5 consecutive days of twice daily dosing in a phase 1 clinic for serial PK sampling.
4553|NCT02921295|B1|Baseline|Sequential Change of Interventions|Conventional Stubby prostheses will be used in this intervention
4554|NCT02921295|P1|Participant Flow|Sequential Change of Intervention|Conventional Stubby prostheses and Sidekicks prostheses were used in a randomized sequence
4555|NCT02921295|O2|Outcome|Sidekicks|active intervention
4556|NCT02921295|O1|Outcome|Stubbies|Control intervention
4557|NCT02921295|O2|Outcome|Sidekicks|active intervention
4558|NCT02921295|O1|Outcome|Stubbies|control intervention
4559|NCT02921295|O2|Outcome|Sidekicks|Active intervention in cross-over trial
4560|NCT02921295|O1|Outcome|Stubbies|Conventional Stubby prostheses as control intervention in cross-over trial
4561|NCT02921295|E2|Reported Event|Sidekicks|active intervention
4562|NCT02921295|E1|Reported Event|Stubbies|Control intervention
4563|NCT02920957|B1|Baseline|Overall Baseline Characteristics|Includes groups randomized to wear comfilcon A lens first and senofilcon C lens first.
4564|NCT02920957|P2|Participant Flow|Senofilcon C First Then Comfilcon A|Participants randomized to wear the senofilcon C lens first then crossover to comfilcon A
4565|NCT02920957|P1|Participant Flow|Comfilcon A First Then Senofilcon C|Participants randomized to wear the comfilcon A lens first then crossover to Senofilcon C
4566|NCT02920957|O6|Outcome|Senofilcon C After 1 Month|Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.
4567|NCT02920957|O5|Outcome|Senofilcon C After 2 Weeks|Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.
4568|NCT02920957|O4|Outcome|Senofilcon C at Dispense|Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.
4569|NCT02920957|O3|Outcome|Comfilcon A After 1 Month|Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.
4570|NCT02920957|O2|Outcome|Comfilcon A After 2 Weeks|Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.
4571|NCT02920957|O1|Outcome|Comfilcon A at Dispense|Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.
4572|NCT02920957|O6|Outcome|Senofilcon C After 1 Month|Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.
4573|NCT02920957|O5|Outcome|Senofilcon C After 2 Weeks|Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.
4574|NCT02920957|O4|Outcome|Senofilcon C at Dispense|Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.
4575|NCT02920957|O3|Outcome|Comfilcon A After 1 Month|Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.
4576|NCT02920957|O2|Outcome|Comfilcon A After 2 Weeks|Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.
4577|NCT02920957|O1|Outcome|Comfilcon A at Dispense|Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.
4578|NCT02920957|O6|Outcome|Senofilcon C After 1 Month|Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.
4579|NCT02920957|O5|Outcome|Senofilcon c After 2 Weeks|Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.
4580|NCT02920957|O4|Outcome|Senofilcon C at Dispense|Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.
4581|NCT02920957|O3|Outcome|Comfilcon A After 1 Month|Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.
4582|NCT02920957|O2|Outcome|Comfilcon A After 2 Weeks|Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.
4583|NCT02920957|O1|Outcome|Comfilcon A at Dispense|Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.
4584|NCT02920957|O6|Outcome|Senofilcon C After 1 Month|Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.
4585|NCT02920957|O5|Outcome|Senofilcon C After 2 Weeks|Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.
4586|NCT02920957|O4|Outcome|Senofilcon C at Dispense|Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.
4587|NCT02920957|O3|Outcome|Comfilcon A After 1 Month|Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.
4588|NCT02920957|O2|Outcome|Comfilcon A After 2 Weeks|Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.
4589|NCT02920957|O1|Outcome|Comfilcon A at Dispense|Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.
4590|NCT02920957|O6|Outcome|Senofilcon C After 1 Month|Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.
4591|NCT02920957|O5|Outcome|Senofilcon C After 2 Weeks|Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.
5958|NCT02811965|E4|Reported Event|Heel Foam Pillow|Pressure mapping is performed with the heel foam pillow device applied to the heel.
4594|NCT02920957|O2|Outcome|Comfilcon A After 2 Weeks|Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.
4595|NCT02920957|O1|Outcome|Comfilcon A at Dispense|Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.
4596|NCT02920957|O6|Outcome|Senofilcon C After 1 Month|Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.
4597|NCT02920957|O5|Outcome|Senofilcon C After 2 Weeks|Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.
4598|NCT02920957|O4|Outcome|Senofilcon C at Dispense|Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.
4599|NCT02920957|O3|Outcome|Comfilcon A After 1 Month|Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.
4600|NCT02920957|O2|Outcome|Comfilcon A After 2 Weeks|Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.
4601|NCT02920957|O1|Outcome|Comfilcon A at Dispense|Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.
4602|NCT02920957|O6|Outcome|Senofilcon C After 1 Month|Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.
4603|NCT02920957|O5|Outcome|Senofilcon C After 2 Weeks|Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.
4604|NCT02920957|O4|Outcome|Senofilcon C at Dispense|Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.
4605|NCT02920957|O3|Outcome|Comfilcon A After 1 Month|Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.
4606|NCT02920957|O2|Outcome|Comfilcon A After 2 Weeks|Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.
4607|NCT02920957|O1|Outcome|Comfilcon A at Dispense|Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.
4608|NCT02920957|O6|Outcome|Senofilcon C After 1 Month|"Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.~senofilcon C: contact lens"
4609|NCT02920957|O5|Outcome|Senofilcon C After 2 Weeks|"Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.~senofilcon C: contact lens"
4610|NCT02920957|O4|Outcome|Senofilcon C at Dispense|"Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.~senofilcon C: contact lens"
4611|NCT02920957|O3|Outcome|Comfilcon A After 1 Month|"Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.~comfilcon A: contact lens"
4612|NCT02920957|O2|Outcome|Comfilcon A After 2 Weeks|"Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.~comfilcon A: contact lens"
4613|NCT02920957|O1|Outcome|Comfilcon A at Dispense|"Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.~comfilcon A: contact lens"
4614|NCT02920957|E2|Reported Event|Senofilcon C|Participants are randomized to wear the senofilcon C lens for one month during either as the first or second intervention.
4615|NCT02920957|E1|Reported Event|Comfilcon A|Participants are randomized to wear the comfilcon A lens for one month during either as the first or second intervention.
4616|NCT02920749|B5|Baseline|Total|Total of all reporting groups
4617|NCT02920749|B4|Baseline|Group D|Anaesthesia was maintained with propofol and the depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too.
4618|NCT02920749|B3|Baseline|Group C|General anaesthesia was maintained with propofol.
4619|NCT02920749|B2|Baseline|Group B|Anaesthesia was maintained with sevoflurane and the depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too.
4620|NCT02920749|B1|Baseline|Group A|General anaesthesia was maintained with sevoflurane.
4621|NCT02920749|P4|Participant Flow|Group D|In this group anaesthesia was maintained with propofol. The depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too. Propofol and fentanyl dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. Neuromuscular blocking was maintained with a TOF monitor at the level of one or no response.
4622|NCT02920749|P3|Participant Flow|Group C|Anaesthesia was maintained with propofol. Propofol was administered according to protocol. Propofol and fentanyl dosing was adjusted for the same MAP range. Atracurium was administered at regular intervals.
4623|NCT02920749|P2|Participant Flow|Group B|In this group anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. The depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too. Sevoflurane and fentanyl dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. Neuromuscular blocking was maintained with a TOF monitor at the level of one or no response.
4624|NCT02920749|P1|Participant Flow|Group A|Anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. Sevoflurane and fentanyl dosing was adjusted for the same MAP range for controlled hypotension within 60-85 mmHg. Atracurium was administered at regular intervals.
4625|NCT02920749|O4|Outcome|Group D|"Drugs at induction were: fentanyl, propofol 1%, atracurium. Anaesthesia was maintained with propofol, fentanyl and atracurium.~Cost was calculated in euros/1 hour. Disposable cost was calculated in euros. In this group BIS sensor and TOF monitoring was used."
4626|NCT02920749|O3|Outcome|Group C|"Drugs at induction were: fentanyl, propofol 1%, atracurium. Anaesthesia was maintained with propofol 1%, fentanyl and atracurium.~Cost was calculated in euros/1 hour. Disposable cost was calculated in euros."
4668|NCT02915978|O2|Outcome|Lower Dose Fentanyl Sublingual Spray|"Lower dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4627|NCT02920749|O2|Outcome|Group B|"Drugs at induction were: fentanyl, propofol 1%, atracurium. Anaesthesia was maintained with sevoflurane, fentanyl and atracurium.~Cost was calculated in euros/1 hour. Disposable cost was calculated in euros. In this group BIS sensor and TOF monitoring was used."
4628|NCT02920749|O1|Outcome|Group A|"Drugs at induction were: fentanyl, propofol 1%, atracurium. Anaesthesia was maintained with sevoflurane, fentanyl and atracurium.~Cost was calculated in euros/1 hour. Disposable cost was calculated in euros."
4629|NCT02920749|O4|Outcome|Group D|Fentanyl consumption was studied during total intravenous anaesthesia with BIS and TOF monitoring. It was registered in milligram.
4630|NCT02920749|O3|Outcome|Group C|Fentanyl consumption was studied during total intravenous anaesthesia. It was registered in milligram.
4631|NCT02920749|O2|Outcome|Group B|Fentanyl consumption was studied during sevoflurane anaesthesia with BIS and TOF monitoring. It was registered in milligram.
4632|NCT02920749|O1|Outcome|Group A|Fentanyl consumption was studied during sevoflurane anaesthesia. It was registered in milligram.
4633|NCT02920749|E4|Reported Event|Group D|During anaesthesia TIVA was applied with a protocol (6 to 8 mg/kg/h propofol). Fentanyl consumption was studied during anaesthesia. It was registered in milligram.
4634|NCT02920749|E3|Reported Event|Group C|During anaesthesia TIVA was applied with a protocol (6 to 8 mg/kg/h propofol). Fentanyl consumption was studied during anaesthesia. It was registered in milligram.
4635|NCT02920749|E2|Reported Event|Group B|"Anaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture.~Fentanyl consumption was studied during anaesthesia. It was registered in milligram."
4636|NCT02920749|E1|Reported Event|Group A|"Anaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture.~Fentanyl consumption was studied during anaesthesia. It was registered in milligram."
4637|NCT02919657|B1|Baseline|All Participants|All participants were given a baseline blood analysis
4638|NCT02919657|P2|Participant Flow|Whey Protein Isolate Then Genepro Gen2 Protein|"30g Serving of Whey Isolate Protein will be used daily in each subject.~1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject."
4639|NCT02919657|P1|Participant Flow|Genepro Gen2 Protein Then Whey Protein|"1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject.~30g Serving of Whey Isolate Protein will be used daily in each subject."
4640|NCT02919657|O2|Outcome|Whey Protein Isolate|"30g Serving of Whey Isolate Protein will be used daily in each subject.~Intervention: Weekly blood draws will determine the effect on blood protein levels.~Whey Protein: weekly blood draws to measure blood protein levels"
4641|NCT02919657|O1|Outcome|Genepro Gen2 Protein|"1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject.~Intervention: Weekly blood draws will determine the effect on blood protein levels.~Genepro Protein: weekly blood draws to measure blood protein levels"
4642|NCT02919657|E2|Reported Event|Whey Protein Isolate|"30g Serving of Whey Isolate Protein will be used daily in each subject.~Intervention: Weekly blood draws will determine the effect on blood protein levels.~Whey Protein: weekly blood draws to measure blood protein levels"
4643|NCT02919657|E1|Reported Event|Genepro Gen2 Protein|"1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject.~Intervention: Weekly blood draws will determine the effect on blood protein levels.~Genepro Protein: weekly blood draws to measure blood protein levels"
4644|NCT02918396|B4|Baseline|Total|Total of all reporting groups
4645|NCT02918396|B3|Baseline|PVI + Modeling-predicted Rotors Ablation|"Rotor Anchors Radio-frequency Ablation: Pulmonary vein isolation followed by radio-frequency ablation of rotor anchors predicted by modeling.~Rotor Anchors Radio-frequency Ablation: Left atrial (LA) myocardium will be manually segmented prior to the procedure and the LA shell, along with the LGE-MRI will be sent to the biomedical engineering team who will generate a 3D-model of the LA along with rotor anchor sites predicted by modeling. After the PVI, the 3D models will be displayed and the rotor anchor sites will be targeted by radiofrequency ablation with a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation."
4646|NCT02918396|B2|Baseline|PVI + Scar-based Ablation|"Scar-Based Radio-frequency Ablation: Pulmonary vein isolation followed by targeting, using radio-frequency ablation, of dense LGE sites on MRI, which are confirmed on bipolar mapping to have voltage <0.3 mV.~Scar-Based Radio-frequency Ablation: Left atrial (LA) myocardium will be manually segmented prior to the procedure and 3D-volumes of the atrial anatomy with superimposed dense LGE maps will be generated. Prior to the PVI, a dense voltage map of the left atrium will be performed (>1000 points) iin sinus rhythm. After PVI, low voltage areas (defined as <0.3 mV) which are superimposed on dense LGE on the MRI will be targeted by radio frequency ablation with a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation."
4647|NCT02918396|B1|Baseline|Conventional PVI|"Conventional PVI by Radio-frequency Ablation: Wide area circumferential pulmonary vein isolation (PVI) only (current standard of care) using radio-frequency ablation catheters.~Conventional PVI by Radio-frequency Ablation: Conventional wide area circumferential ablation (WACA) pulmonary vein isolation will be performed using a contact-force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation."
4648|NCT02918396|P3|Participant Flow|PVI + Modeling-predicted Rotors Ablation|"Rotor Anchors Radio-frequency Ablation: Pulmonary vein isolation followed by radio-frequency ablation of rotor anchors predicted by modeling.~Rotor Anchors Radio-frequency Ablation: Left atrial (LA) myocardium will be manually segmented prior to the procedure and the LA shell, along with the LGE-MRI will be sent to the biomedical engineering team who will generate a 3D-model of the LA along with rotor anchor sites predicted by modeling. After the PVI, the 3D models will be displayed and the rotor anchor sites will be targeted by radiofrequency ablation with a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation."
4669|NCT02915978|O1|Outcome|Higher Dose Fentanyl Sublingual Spray|"Higher dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4670|NCT02915978|O3|Outcome|Placebo|"Placebo (matching Fentany) delivered via sublingual spray every 4 hours.~Placebo: Matching placebo delivered via sublingual spray"
4671|NCT02915978|O2|Outcome|Lower Dose Fentanyl Sublingual Spray|"Lower dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
5959|NCT02811965|E3|Reported Event|Pillow Condition 2|Pressure mapping is performed with the Pillow condition 2 applied to the heel.
4649|NCT02918396|P2|Participant Flow|PVI + Scar-based Ablation|"Scar-Based Radio-frequency Ablation: Pulmonary vein isolation followed by targeting, using radio-frequency ablation, of dense LGE sites on MRI, which are confirmed on bipolar mapping to have voltage <0.3 mV.~Scar-Based Radio-frequency Ablation: Left atrial (LA) myocardium will be manually segmented prior to the procedure and 3D-volumes of the atrial anatomy with superimposed dense LGE maps will be generated. Prior to the PVI, a dense voltage map of the left atrium will be performed (>1000 points) iin sinus rhythm. After PVI, low voltage areas (defined as <0.3 mV) which are superimposed on dense LGE on the MRI will be targeted by radio frequency ablation with a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation."
4650|NCT02918396|P1|Participant Flow|Conventional PVI|"Conventional PVI by Radio-frequency Ablation: Wide area circumferential pulmonary vein isolation (PVI) only (current standard of care) using radio-frequency ablation catheters.~Conventional PVI by Radio-frequency Ablation: Conventional wide area circumferential ablation (WACA) pulmonary vein isolation will be performed using a contact-force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation."
4651|NCT02918396|O3|Outcome|PVI + Modeling-predicted Rotors Ablation|"Rotor Anchors Radio-frequency Ablation: Pulmonary vein isolation followed by radio-frequency ablation of rotor anchors predicted by modeling.~Rotor Anchors Radio-frequency Ablation: Left atrial (LA) myocardium will be manually segmented prior to the procedure and the LA shell, along with the LGE-MRI will be sent to the biomedical engineering team who will generate a 3D-model of the LA along with rotor anchor sites predicted by modeling. After the PVI, the 3D models will be displayed and the rotor anchor sites will be targeted by radiofrequency ablation with a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation."
4652|NCT02918396|O2|Outcome|PVI + Scar-based Ablation|"Scar-Based Radio-frequency Ablation: Pulmonary vein isolation followed by targeting, using radio-frequency ablation, of dense LGE sites on MRI, which are confirmed on bipolar mapping to have voltage <0.3 mV.~Scar-Based Radio-frequency Ablation: Left atrial (LA) myocardium will be manually segmented prior to the procedure and 3D-volumes of the atrial anatomy with superimposed dense LGE maps will be generated. Prior to the PVI, a dense voltage map of the left atrium will be performed (>1000 points) iin sinus rhythm. After PVI, low voltage areas (defined as <0.3 mV) which are superimposed on dense LGE on the MRI will be targeted by radio frequency ablation with a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation."
4653|NCT02918396|O1|Outcome|Conventional PVI|"Conventional PVI by Radio-frequency Ablation: Wide area circumferential pulmonary vein isolation (PVI) only (current standard of care) using radio-frequency ablation catheters.~Conventional PVI by Radio-frequency Ablation: Conventional wide area circumferential ablation (WACA) pulmonary vein isolation will be performed using a contact-force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation."
4654|NCT02918396|E3|Reported Event|PVI + Modeling-predicted Rotors Ablation|"Rotor Anchors Radio-frequency Ablation: Pulmonary vein isolation followed by radio-frequency ablation of rotor anchors predicted by modeling.~Rotor Anchors Radio-frequency Ablation: Left atrial (LA) myocardium will be manually segmented prior to the procedure and the LA shell, along with the LGE-MRI will be sent to the biomedical engineering team who will generate a 3D-model of the LA along with rotor anchor sites predicted by modeling. After the PVI, the 3D models will be displayed and the rotor anchor sites will be targeted by radiofrequency ablation with a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation."
4655|NCT02918396|E2|Reported Event|PVI + Scar-based Ablation|"Scar-Based Radio-frequency Ablation: Pulmonary vein isolation followed by targeting, using radio-frequency ablation, of dense LGE sites on MRI, which are confirmed on bipolar mapping to have voltage <0.3 mV.~Scar-Based Radio-frequency Ablation: Left atrial (LA) myocardium will be manually segmented prior to the procedure and 3D-volumes of the atrial anatomy with superimposed dense LGE maps will be generated. Prior to the PVI, a dense voltage map of the left atrium will be performed (>1000 points) iin sinus rhythm. After PVI, low voltage areas (defined as <0.3 mV) which are superimposed on dense LGE on the MRI will be targeted by radio frequency ablation with a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation."
4656|NCT02918396|E1|Reported Event|Conventional PVI|"Conventional PVI by Radio-frequency Ablation: Wide area circumferential pulmonary vein isolation (PVI) only (current standard of care) using radio-frequency ablation catheters.~Conventional PVI by Radio-frequency Ablation: Conventional wide area circumferential ablation (WACA) pulmonary vein isolation will be performed using a contact-force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation."
4657|NCT02915978|B4|Baseline|Total|Total of all reporting groups
4658|NCT02915978|B3|Baseline|Placebo|"Placebo (matching Fentany) delivered via sublingual spray every 4 hours.~Placebo: Matching placebo delivered via sublingual spray"
4659|NCT02915978|B2|Baseline|Lower Dose Fentanyl Sublingual Spray|"Lower dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4660|NCT02915978|B1|Baseline|Higher Dose Fentanyl Sublingual Spray|"Higher dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4661|NCT02915978|P3|Participant Flow|Placebo|"Placebo (matching Fentany) delivered via sublingual spray every 4 hours.~Placebo: Matching placebo delivered via sublingual spray"
4662|NCT02915978|P2|Participant Flow|Lower Dose Fentanyl|"Lower dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4663|NCT02915978|P1|Participant Flow|Higher Dose Fentanyl Sublingual Spray|"Higher dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4664|NCT02915978|O3|Outcome|Placebo|"Placebo (matching Fentany) delivered via sublingual spray every 4 hours.~Placebo: Matching placebo delivered via sublingual spray"
4665|NCT02915978|O2|Outcome|Lower Dose Fentanyl Sublingual Spray|"Lower dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4666|NCT02915978|O1|Outcome|Higher Dose Fentanyl Sublingual Spray|"Higher dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4667|NCT02915978|O3|Outcome|Placebo|"Placebo (matching Fentany) delivered via sublingual spray every 4 hours.~Placebo: Matching placebo delivered via sublingual spray"
6116|NCT02806544|E1|Reported Event|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
4672|NCT02915978|O1|Outcome|Higher Dose Fentanyl Sublingual Spray|"Higher dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4673|NCT02915978|O3|Outcome|Placebo|"Placebo (matching Fentany) delivered via sublingual spray every 4 hours.~Placebo: Matching placebo delivered via sublingual spray"
4674|NCT02915978|O2|Outcome|Lower Dose Fentanyl Sublingual Spray|"Lower dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4675|NCT02915978|O1|Outcome|Higher Dose Fentanyl Sublingual Spray|"Higher dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4676|NCT02915978|O3|Outcome|Placebo|"Placebo (matching Fentany) delivered via sublingual spray every 4 hours.~Placebo: Matching placebo delivered via sublingual spray"
4677|NCT02915978|O2|Outcome|Lower Dose Fentanyl Sublingual Spray|"Lower dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4678|NCT02915978|O1|Outcome|Higher Dose Fentanyl Sublingual Spray|"Higher dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4679|NCT02915978|O3|Outcome|Placebo|"Placebo (matching Fentany) delivered via sublingual spray every 4 hours.~Placebo: Matching placebo delivered via sublingual spray"
4680|NCT02915978|O2|Outcome|Lower Dose Fentanyl Sublingual Spray|"Lower dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4681|NCT02915978|O1|Outcome|Higher Dose Fentanyl Sublingual Spray|"Higher dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4682|NCT02915978|O3|Outcome|Placebo|"Placebo (matching Fentany) delivered via sublingual spray every 4 hours.~Placebo: Matching placebo delivered via sublingual spray"
4683|NCT02915978|O2|Outcome|Lower Dose Fentanyl Sublingual Spray|"Lower dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4684|NCT02915978|O1|Outcome|Higher Dose Fentanyl Sublingual Spray|"Higher dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4685|NCT02915978|O3|Outcome|Placebo|"Placebo (matching Fentany) delivered via sublingual spray every 4 hours.~Placebo: Matching placebo delivered via sublingual spray"
4686|NCT02915978|O2|Outcome|Lower Dose Fentanyl Sublingual Spray|"Lower dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4687|NCT02915978|O1|Outcome|Higher Dose Fentanyl Sublingual Spray|"Higher dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4688|NCT02915978|O3|Outcome|Placebo|"Placebo (matching Fentany) delivered via sublingual spray every 4 hours.~Placebo: Matching placebo delivered via sublingual spray"
4689|NCT02915978|O2|Outcome|Lower Dose Fentanyl Sublingual Spray|"Lower dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4690|NCT02915978|O1|Outcome|Higher Dose Fentanyl Sublingual Spray|"Higher dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4691|NCT02915978|O3|Outcome|Placebo|"Placebo (matching Fentany) delivered via sublingual spray every 4 hours.~Placebo: Matching placebo delivered via sublingual spray"
4692|NCT02915978|O2|Outcome|Lower Dose Fentanyl Sublingual Spray|"Lower dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4693|NCT02915978|O1|Outcome|Higher Dose Fentanyl Sublingual Spray|"Higher dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4694|NCT02915978|O3|Outcome|Placebo|"Placebo (matching Fentany) delivered via sublingual spray every 4 hours.~Placebo: Matching placebo delivered via sublingual spray"
4695|NCT02915978|O2|Outcome|Lower Dose Fentanyl Sublingual Spray|"Lower dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4696|NCT02915978|O1|Outcome|Higher Dose Fentanyl Sublingual Spray|"Higher dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4697|NCT02915978|O3|Outcome|Placebo|"Placebo (matching Fentany) delivered via sublingual spray every 4 hours.~Placebo: Matching placebo delivered via sublingual spray"
4698|NCT02915978|O2|Outcome|Lower Dose Fentanyl Sublingual Spray|"Lower dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4699|NCT02915978|O1|Outcome|Higher Dose Fentanyl Sublingual Spray|"Higher dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4700|NCT02915978|O3|Outcome|Placebo|"Placebo (matching Fentany) delivered via sublingual spray every 4 hours.~Placebo: Matching placebo delivered via sublingual spray"
4701|NCT02915978|O2|Outcome|Lower Dose Fentanyl Sublingual Spray|"Lower dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4702|NCT02915978|O1|Outcome|Higher Dose Fentanyl Sublingual Spray|"Higher dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4703|NCT02915978|O3|Outcome|Placebo|"Placebo (matching Fentany) delivered via sublingual spray every 4 hours.~Placebo: Matching placebo delivered via sublingual spray"
4704|NCT02915978|O2|Outcome|Lower Dose Fentanyl Sublingual Spray|"Lower dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4705|NCT02915978|O1|Outcome|Higher Dose Fentanyl Sublingual Spray|"Higher dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4706|NCT02915978|O3|Outcome|Placebo|"Placebo (matching Fentany) delivered via sublingual spray every 4 hours.~Placebo: Matching placebo delivered via sublingual spray"
4707|NCT02915978|O2|Outcome|Lower Dose Fentanyl Sublingual Spray|"Lower dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4708|NCT02915978|O1|Outcome|Higher Dose Fentanyl Sublingual Spray|"Higher dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4709|NCT02915978|E3|Reported Event|Placebo|"Placebo (matching Fentany) delivered via sublingual spray every 4 hours.~Placebo: Matching placebo delivered via sublingual spray"
4778|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
4710|NCT02915978|E2|Reported Event|Lower Dose Fentanyl Sublingual Spray|"Lower dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4711|NCT02915978|E1|Reported Event|Higher Dose Fentanyl Sublingual Spray|"Higher dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
4712|NCT02915302|B3|Baseline|Total|Total of all reporting groups
4713|NCT02915302|B2|Baseline|Fluzone Quadrivalent Vaccine, 0.5-mL|Participants received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.5-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.
4714|NCT02915302|B1|Baseline|Fluzone Quadrivalent Vaccine, 0.25-mL|Participants received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.25-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.
4715|NCT02915302|P2|Participant Flow|Fluzone Quadrivalent Vaccine, 0.5-mL|Participants received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.5-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.
4716|NCT02915302|P1|Participant Flow|Fluzone Quadrivalent Vaccine, 0.25-mL|Participants received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second 0.25-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.
4717|NCT02915302|O2|Outcome|Fluzone Quadrivalent Vaccine, 0.5-mL|Participants received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.5-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.
4718|NCT02915302|O1|Outcome|Fluzone Quadrivalent Vaccine, 0.25-mL|Participants received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.25-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.
4719|NCT02915302|O2|Outcome|Fluzone Quadrivalent Vaccine, 0.5-mL|Participants received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.5-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.
4720|NCT02915302|O1|Outcome|Fluzone Quadrivalent Vaccine, 0.25-mL|Participants received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.25-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.
4721|NCT02915302|O2|Outcome|Fluzone Quadrivalent Vaccine, 0.5-mL|Participants received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.5-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.
4722|NCT02915302|O1|Outcome|Fluzone Quadrivalent Vaccine, 0.25-mL|Participants received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.25-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.
4723|NCT02915302|E2|Reported Event|Fluzone Quadrivalent Vaccine, 0.5-mL|Participants received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.5-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.
4724|NCT02915302|E1|Reported Event|Fluzone Quadrivalent Vaccine, 0.25-mL|Participants received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.25-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.
4725|NCT02914236|B1|Baseline|Vivaer Stylus|"Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area~Vivaer Stylus: Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area"
4726|NCT02914236|P1|Participant Flow|Vivaer Stylus|"Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area~Vivaer Stylus: Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area"
4727|NCT02914236|O1|Outcome|Vivaer Stylus|"Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area~Vivaer Stylus: Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area"
4728|NCT02914236|O1|Outcome|Vivaer Stylus|"Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area~Vivaer Stylus: Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area"
4729|NCT02914236|O1|Outcome|Vivaer Stylus|"Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area~Vivaer Stylus: Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area"
4730|NCT02914236|O1|Outcome|Vivaer Stylus|"Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area~Vivaer Stylus: Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area"
4731|NCT02914236|O1|Outcome|Vivaer Stylus|"Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area~Vivaer Stylus: Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area"
4732|NCT02914236|E1|Reported Event|Vivaer Stylus|"Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area~Vivaer Stylus: Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area"
4733|NCT02912650|B5|Baseline|Total|Total of all reporting groups
4734|NCT02912650|B4|Baseline|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
4735|NCT02912650|B3|Baseline|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
4736|NCT02912650|B2|Baseline|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
4737|NCT02912650|B1|Baseline|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
4738|NCT02912650|P4|Participant Flow|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
4739|NCT02912650|P3|Participant Flow|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
4740|NCT02912650|P2|Participant Flow|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
4741|NCT02912650|P1|Participant Flow|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
4742|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
4743|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
4744|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
4745|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
4746|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
4747|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
4748|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
4749|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
4750|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
4751|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
4752|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
4753|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
4754|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
4755|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
4756|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
4757|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
4758|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
4759|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
4760|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
4761|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
4762|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
4763|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
4764|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
4765|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
4766|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
4767|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
4768|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
4769|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
4770|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
4771|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
4772|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
4773|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
4774|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
4775|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
4776|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
4777|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
4779|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
4780|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
4781|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
4782|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
4783|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
4784|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
4785|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
4786|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
4787|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
4788|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
4789|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
4790|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
4791|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
4792|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
4793|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
4794|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
4795|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
4796|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
4797|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
4798|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
4799|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
4800|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
4801|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
4802|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
4803|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
4804|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
4805|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
4806|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
4807|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
4808|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
4809|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
4810|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
4811|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
4812|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
4813|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
4814|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
4815|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
4816|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
4817|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
4818|NCT02912650|E4|Reported Event|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
4819|NCT02912650|E3|Reported Event|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
4820|NCT02912650|E2|Reported Event|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
4823|NCT02910362|B2|Baseline|AMO Phacoemulsification Equipment|"cataract surgery with the AMO phacoemulsification equipment~AMO phacoemulsification equipment: cataract surgery with AMO phacoemulsification equipment."
4824|NCT02910362|B1|Baseline|Alcon Phacoemulsification Equipment|"cataract surgery performed with the Alcon phacoemulsification equipment~Alcon phacoemulsification equipment: cataract surgery with Alcon phacoemulsification equipment."
4825|NCT02910362|P2|Participant Flow|AMO Phacoemulsification Equipment|"cataract surgery with the AMO phacoemulsification equipment~AMO phacoemulsification equipment: cataract surgery with AMO phacoemulsification equipment."
4826|NCT02910362|P1|Participant Flow|Alcon Phacoemulsification Equipment|"cataract surgery performed with the Alcon phacoemulsification equipment~Alcon phacoemulsification equipment: cataract surgery with Alcon phacoemulsification equipment."
4827|NCT02910362|O2|Outcome|AMO Phacoemulsification Equipment|"cataract surgery with the AMO phacoemulsification equipment~AMO phacoemulsification equipment: cataract surgery with AMO phacoemulsification equipment."
4828|NCT02910362|O1|Outcome|Alcon Phacoemulsification Equipment|"cataract surgery performed with the Alcon phacoemulsification equipment~Alcon phacoemulsification equipment: cataract surgery with Alcon phacoemulsification equipment."
4829|NCT02910362|E2|Reported Event|AMO Phacoemulsification Equipment|"cataract surgery with the AMO phacoemulsification equipment~AMO phacoemulsification equipment: cataract surgery with AMO phacoemulsification equipment."
4830|NCT02910362|E1|Reported Event|Alcon Phacoemulsification Equipment|"cataract surgery performed with the Alcon phacoemulsification equipment~Alcon phacoemulsification equipment: cataract surgery with Alcon phacoemulsification equipment."
4831|NCT02908269|B4|Baseline|Total|Total of all reporting groups
4832|NCT02908269|B3|Baseline|Fluzone High-Dose Vaccine Group 3: ≥ 65 Years|Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
4833|NCT02908269|B2|Baseline|Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years|Participants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
4834|NCT02908269|B1|Baseline|Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years|Participants aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28.
4835|NCT02908269|P3|Participant Flow|Fluzone High-Dose Vaccine Group 3: ≥ 65 Years|Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
4836|NCT02908269|P2|Participant Flow|Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years|Participants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
4837|NCT02908269|P1|Participant Flow|Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years|Participants aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28.
4838|NCT02908269|O1|Outcome|Fluzone High-Dose Vaccine Group 3: ≥ 65 Years|Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
4839|NCT02908269|O1|Outcome|Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years|Participants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
4840|NCT02908269|O1|Outcome|Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years|Participants aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28.
4841|NCT02908269|O1|Outcome|Fluzone High-Dose Vaccine Group 3: ≥ 65 Years|Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
4842|NCT02908269|O1|Outcome|Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years|Participants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
4843|NCT02908269|O1|Outcome|Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years|Participants aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28.
4844|NCT02908269|O2|Outcome|Fluzone High-Dose Vaccine Group 3: ≥ 65 Years|Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
4845|NCT02908269|O1|Outcome|Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years|Participants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
4846|NCT02908269|O1|Outcome|Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years|Participants aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28.
4847|NCT02908269|E3|Reported Event|Fluzone High-Dose Vaccine Group 3: ≥ 65 Years|Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
4848|NCT02908269|E2|Reported Event|Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years|Participants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
4849|NCT02908269|E1|Reported Event|Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years|Participants aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28.
4850|NCT02907268|B3|Baseline|Total|Total of all reporting groups
4874|NCT02895347|B2|Baseline|Experimental Group|Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then participants were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until proficiency (91%) in all 4 activities was reached. Participants were asked to return and were filmed and timed completing a suturing activity on the porcine model.
4851|NCT02907268|B2|Baseline|Treatment Arm B|The second treatment group received abobotulinumtoxinA (Dysport) on the right side of their face and onabotulinumtoxinA (Botox) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized. OnabotulinumtoxinA was approved by the FDA in 2002. AbobotulinumtoxinA was approved by the FDA in 2009. Intervention administered by study nurse. Intradermal administered in a regular 1 cm2 grid across the cheeks and forehead. Intramuscular administered according to normal practice.
4852|NCT02907268|B1|Baseline|Treatment Arm A|The first treatment group received onabotulinumtoxinA (Botox) on the right side of their face and abobotulinumtoxinA (Dysport) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized. OnabotulinumtoxinA was approved by the FDA in 2002. AbobotulinumtoxinA was approved by the FDA in 2009. Intervention administered by study nurse. Intradermal administered in a regular 1 cm2 grid across the cheeks and forehead. Intramuscular administered according to normal practice.
4853|NCT02907268|P2|Participant Flow|Treatment Arm B|"The second treatment group received abobotulinumtoxinA (Dysport) on the right side of their face and onabotulinumtoxinA (Botox) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized.~onabotulinumtoxinA: OnabotulinumtoxinA (Botox; Allergan) was approved by the FDA in 2002. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead.~abobotulinumtoxinA: AbobotulinumtoxinA (Dysport; Galderma) was approved by the FDA in 2009. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across"
4854|NCT02907268|P1|Participant Flow|Treatment Arm A|"The first treatment group received onabotulinumtoxinA (Botox) on the right side of their face and abobotulinumtoxinA (Dysport) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized.~onabotulinumtoxinA: OnabotulinumtoxinA (Botox; Allergan) was approved by the FDA in 2002. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead.~abobotulinumtoxinA: AbobotulinumtoxinA (Dysport; Galderma) was approved by the FDA in 2009. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across"
4855|NCT02907268|O1|Outcome|Arm 1|Overall change in wrinkles score. This is calculated per patient, regardless of randomization.
4856|NCT02907268|O1|Outcome|Arm 1|Overall change in wrinkles score. This is calculated per patient, regardless of randomization.
4857|NCT02907268|O1|Outcome|Arm 1|Overall change in wrinkles score. This is calculated per patient, regardless of randomization.
4858|NCT02907268|E2|Reported Event|Treatment Arm B|"The second treatment group received abobotulinumtoxinA (Dysport) on the right side of their face and onabotulinumtoxinA (Botox) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized.~onabotulinumtoxinA: OnabotulinumtoxinA was approved by the FDA in 2002. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead.~abobotulinumtoxinA: AbobotulinumtoxinA was approved by the FDA in 2009. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead."
4859|NCT02907268|E1|Reported Event|Treatment Arm A|"The first treatment group received onabotulinumtoxinA (Botox) on the right side of their face and abobotulinumtoxinA (Dysport) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized.~onabotulinumtoxinA: OnabotulinumtoxinA was approved by the FDA in 2002. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead.~abobotulinumtoxinA: AbobotulinumtoxinA was approved by the FDA in 2009. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead."
4860|NCT02903238|B1|Baseline|Placebo|"placebo capsule~placebo: lactose containing capsule"
4861|NCT02903238|P1|Participant Flow|Placebo|"placebo capsule~placebo: lactose containing capsule"
4862|NCT02903238|O2|Outcome|Placebo Non-responders|"placebo capsule~placebo: lactose containing capsule"
4863|NCT02903238|O1|Outcome|Placebo Responders|"placebo capsule~placebo: lactose containing capsule"
4864|NCT02903238|O2|Outcome|Placebo Non-responders|"placebo capsule~placebo: lactose containing capsule"
4865|NCT02903238|O1|Outcome|Placebo Responders|"placebo capsule~placebo: lactose containing capsule"
4866|NCT02903238|O2|Outcome|Placebo Non-responders|"placebo capsule~placebo: lactose containing capsule"
4867|NCT02903238|O1|Outcome|Placebo Responders|"placebo capsule~placebo: lactose containing capsule"
4868|NCT02903238|E1|Reported Event|Placebo|"placebo capsule~placebo: lactose containing capsule"
4869|NCT02901054|B1|Baseline|Open Label Infusion Ondansetron|The entire cohort of subjects in this open-label study
6117|NCT02806505|B3|Baseline|Total|Total of all reporting groups
4875|NCT02895347|B1|Baseline|Control Group|Participants in the Control Group (CG) were asked to attend an orientation reviewing the study. Three weeks later participants returned and were filmed timed completing a suturing activity on the porcine model.
4876|NCT02895347|P2|Participant Flow|Experimental Group|Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then participants were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until proficiency (91%) in all 4 activities was reached. Participants were asked to return and were filmed and timed completing a suturing activity on the porcine model.
4877|NCT02895347|P1|Participant Flow|Control Group|Participants in the Control Group (CG) were asked to attend an orientation reviewing the study. Three weeks later participants returned and were filmed timed completing a suturing activity on the porcine model.
4878|NCT02895347|O1|Outcome|Experimental Group|"Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then they were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until they reached proficiency (91%) in all 4 activities. 4. Participants were asked to return where they were filmed and timed completing a suturing activity on the porcine model.~Surgical Simulation Practice Modules: The surgical simulation practice modules simulate surgical settings for suturing."
4879|NCT02895347|O2|Outcome|Experimental Group|Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then participants were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until proficiency (91%) in all 4 activities was reached. Participants were asked to return and were filmed and timed completing a suturing activity on the porcine model.
4880|NCT02895347|O1|Outcome|Control Group|Participants in the Control Group (CG) were asked to attend an orientation reviewing the study. Three weeks later participants returned and were filmed timed completing a suturing activity on the porcine model.
4881|NCT02895347|O2|Outcome|Experimental Group|Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then participants were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until proficiency (91%) in all 4 activities was reached. Participants were asked to return and were filmed and timed completing a suturing activity on the porcine model.
4882|NCT02895347|O1|Outcome|Control Group|Participants in the Control Group (CG) were asked to attend an orientation reviewing the study. Three weeks later participants returned and were filmed timed completing a suturing activity on the porcine model.
4883|NCT02895347|E2|Reported Event|Experimental Group|Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then participants were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until proficiency (91%) in all 4 activities was reached. Participants were asked to return and were filmed and timed completing a suturing activity on the porcine model.
4884|NCT02895347|E1|Reported Event|Control Group|Participants in the Control Group (CG) were asked to attend an orientation reviewing the study. Three weeks later participants returned and were filmed timed completing a suturing activity on the porcine model.
4885|NCT02891863|B1|Baseline|Acute Testing|"Single-arm study - all subjects who meet the I&E criteria, sign the consent form and have inducible VT within the protocol-specified criteria may be tested for VT conversion with the LEVER Acute Study System.~LEVER Acute Study System: The LEVER Acute Study System is an acute pacing and shock delivery system intended for investigational use only. The LEVER Acute Study System is intended for acute conversion testing of monomorphic ventricular tachycardia by one of three different VT conversion methods."
4886|NCT02891863|P1|Participant Flow|Acute Testing|"Single-arm study - all subjects who meet the I&E criteria, sign the consent form and have inducible VT within the protocol-specified criteria may be tested for VT conversion with the LEVER Acute Study System.~LEVER Acute Study System: The LEVER Acute Study System is an acute pacing and shock delivery system intended for investigational use only. The LEVER Acute Study System is intended for acute conversion testing of monomorphic ventricular tachycardia by one of three different VT conversion methods."
4887|NCT02891863|O1|Outcome|Acute Testing|"Single-arm study - all subjects who meet the I&E criteria, sign the consent form and have inducible VT within the protocol-specified criteria may be tested for VT conversion with the LEVER Acute Study System.~LEVER Acute Study System: The LEVER Acute Study System is an acute pacing and shock delivery system intended for investigational use only. The LEVER Acute Study System is intended for acute conversion testing of monomorphic ventricular tachycardia by one of three different VT conversion methods."
4888|NCT02891863|O1|Outcome|Acute Testing|"Single-arm study - all subjects who meet the I&E criteria, sign the consent form and have inducible VT within the protocol-specified criteria may be tested for VT conversion with the LEVER Acute Study System.~LEVER Acute Study System: The LEVER Acute Study System is an acute pacing and shock delivery system intended for investigational use only. The LEVER Acute Study System is intended for acute conversion testing of monomorphic ventricular tachycardia by one of three different VT conversion methods."
4889|NCT02891863|E1|Reported Event|Acute Testing|"Single-arm study - all subjects who meet the I&E criteria, sign the consent form and have inducible VT within the protocol-specified criteria may be tested for VT conversion with the LEVER Acute Study System.~LEVER Acute Study System: The LEVER Acute Study System is an acute pacing and shock delivery system intended for investigational use only. The LEVER Acute Study System is intended for acute conversion testing of monomorphic ventricular tachycardia by one of three different VT conversion methods."
4890|NCT02890303|B1|Baseline|Zepto Capsulotomy|"This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery. Effectiveness Rate – An effectiveness rate of 95% complete capsulotomies provides reasonable assurance that the Zepto system is effective. Primary Safety Endpoint - Posterior Capsular Rupture & Vitreous Loss (4% or less)~Zepto System: Anterior Capsulotomy using the Zepto System."
5027|NCT02873429|B1|Baseline|Integrative Medicine Group|Patients receiving chiropractic care, acupuncture, massage therapy, or meditation training for chronic pain
4891|NCT02890303|P1|Participant Flow|Zepto Capsulotomy|"This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery. Effectiveness Rate – An effectiveness rate of 95% complete capsulotomies provides reasonable assurance that the Zepto system is effective. Primary Safety Endpoint - Posterior Capsular Rupture & Vitreous Loss (4% or less)~Zepto System: Anterior Capsulotomy using the Zepto System."
4892|NCT02890303|O1|Outcome|Zepto Capsulotomy|"This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery. Effectiveness Rate – An effectiveness rate of 95% complete capsulotomies provides reasonable assurance that the Zepto system is effective. Primary Safety Endpoint - Posterior Capsular Rupture & Vitreous Loss (4% or less)~Zepto System: Anterior Capsulotomy using the Zepto System."
4893|NCT02890303|E1|Reported Event|Zepto Capsulotomy|"This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery. Effectiveness Rate – An effectiveness rate of 95% complete capsulotomies provides reasonable assurance that the Zepto system is effective. Primary Safety Endpoint - Posterior Capsular Rupture & Vitreous Loss (4% or less)~Zepto System: Anterior Capsulotomy using the Zepto System."
4894|NCT02889289|B1|Baseline|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.~Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
4895|NCT02889289|P1|Participant Flow|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.~Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
4896|NCT02889289|O1|Outcome|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.~Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
4897|NCT02889289|O1|Outcome|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.~Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
4898|NCT02889289|O1|Outcome|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.~Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
4899|NCT02889289|O1|Outcome|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.~Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
4900|NCT02889289|O1|Outcome|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.~Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
4915|NCT02884427|O2|Outcome|Anode Stimulation|"Group that is involved with the (red) positive electrode seeking the polar effect of nervous excitability and conductivity decreased with the current application.~Anode stimulation: Electrical stimulation through the anode or positive pole, in which a peripheral rib will be subjected to the passage of a direct current seeking to reduce excitability and conductivity during the passage of current."
4987|NCT02877732|O2|Outcome|Control Subject|EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
4901|NCT02889289|O1|Outcome|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.~Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
4902|NCT02889289|E1|Reported Event|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.~Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
4903|NCT02886338|B1|Baseline|Capsule Endoscopy Group|"Capsule endoscopy group: Participants swallowed a magnetic-assisted capsule endoscope, and an external magnetic field navigator is used for magnetic capsule manipulation in the upper gastrointestinal tract.~The movement of the magnetic capsule endoscope can be driven by an external magnetic field navigator. The external magnetic field navigator can also adjust the direction of movement of the capsule in the stomach and duodenum. Through the external magnetic-mediated navigation of the capsule in the upper gastrointestinal tract, clinicians can potentially examine the whole upper gastrointestinal tract."
4904|NCT02886338|P1|Participant Flow|Capsule Endoscopy Group|"The movement of the endoscopic capsule in the esophagus could be driven by an external magnetic control device. The external magnetic control device could also adjust the direction of movement of the capsule in the stomach and duodenum, which might make the examination of the whole upper gastrointestinal tract possible.~capsule endoscopy: The magnetic navigated capsule endoscope would enable detailed investigations of the whole upper gastrointestinal tract, including the esophagus, stomach and duodenum. Using this remote magnetic manipulation, capsule endoscope might improve diagnostic accuracy and extend the examination of specific area of interest in the gastrointestinal tract."
4905|NCT02886338|O1|Outcome|Capsule Endoscopy Group|"Capsule endoscopy group: Participants swallowed a magnetic-assisted capsule endoscope, and an external magnetic field navigator is used for magnetic capsule manipulation in the upper gastrointestinal tract.~The movement of the magnetic capsule endoscope can be driven by an external magnetic field navigator. The external magnetic field navigator can also adjust the direction of movement of the capsule in the stomach and duodenum. Through the external magnetic-mediated navigation of the capsule in the upper gastrointestinal tract, clinicians can potentially examine the whole upper gastrointestinal tract."
4906|NCT02886338|E1|Reported Event|Healthy Subjects With Capsule Endoscopy Examination|"We included participants who were aged from 20 to 65 years. Exclude from the study were those (A) who had obstruction of the GI tract; (B) were pregnant; (C) had pacemaker implantation; (D) were implanted with metal or electronic devices, artificial joints or fixators (E) had cancer; (F) had difficulty in swallowing; (G) had a history of stomach operation.~All participants received the capsule endoscopic examination for the esophagus, stomach and duodenum."
4907|NCT02884427|B4|Baseline|Total|Total of all reporting groups
4908|NCT02884427|B3|Baseline|Control|"Group that will be placed electrotherapy without operation, but only installation. Patients in this group will see the team work but it will not be delivering current.~Placebo: Current application without the actual electric conduction to the person occurs. This will be achieved by adjusting parameters while installing another channel and not one that is working."
4909|NCT02884427|B2|Baseline|Anode Stimulation|"Group that is involved with the (red) positive electrode seeking the polar effect of nervous excitability and conductivity decreased with the current application.~Anode stimulation: Electrical stimulation through the anode or positive pole, in which a peripheral rib will be subjected to the passage of a direct current seeking to reduce excitability and conductivity during the passage of current."
4910|NCT02884427|B1|Baseline|Cathode Stimulation|"Group that is involved with the (black) negative electrode seeking the polar effect of nervous increased excitability and conductivity with the current application.~Cathode stimulation: Electrical stimulation through the cathode or negative pole, in which a peripheral nerve will be subject to the passage of a direct current seeking increased excitability and conductivity during the passage of current."
4911|NCT02884427|P3|Participant Flow|Control|"Group that will be placed electrotherapy without operation, but only installation. Patients in this group will see the team work but it will not be delivering current.~Placebo: Current application without the actual electric conduction to the person occurs. This will be achieved by adjusting parameters while installing another channel and not one that is working."
4912|NCT02884427|P2|Participant Flow|Anode Stimulation|"Group that is involved with the (red) positive electrode seeking the polar effect of nervous excitability and conductivity decreased with the current application.~Anode stimulation: Electrical stimulation through the anode or positive pole, in which a peripheral rib will be subjected to the passage of a direct current seeking to reduce excitability and conductivity during the passage of current."
4913|NCT02884427|P1|Participant Flow|Cathode Stimulation|"Group that is involved with the (black) negative electrode seeking the polar effect of nervous increased excitability and conductivity with the current application.~Cathode stimulation: Electrical stimulation through the cathode or negative pole, in which a peripheral nerve will be subject to the passage of a direct current seeking increased excitability and conductivity during the passage of current."
4914|NCT02884427|O3|Outcome|Control|"Group that will be placed electrotherapy without operation, but only installation. Patients in this group will see the team work but it will not be delivering current.~Placebo: Current application without the actual electric conduction to the person occurs. This will be achieved by adjusting parameters while installing another channel and not one that is working."
4984|NCT02877732|O1|Outcome|Concussed Subject|EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
20029|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
4916|NCT02884427|O1|Outcome|Cathode Stimulation|"Group that is involved with the (black) negative electrode seeking the polar effect of nervous increased excitability and conductivity with the current application.~Cathode stimulation: Electrical stimulation through the cathode or negative pole, in which a peripheral nerve will be subject to the passage of a direct current seeking increased excitability and conductivity during the passage of current."
4917|NCT02884427|O3|Outcome|Control|"Group that will be placed electrotherapy without operation, but only installation. Patients in this group will see the team work but it will not be delivering current.~Placebo: Current application without the actual electric conduction to the person occurs. This will be achieved by adjusting parameters while installing another channel and not one that is working."
4918|NCT02884427|O2|Outcome|Anode Stimulation|"Group that is involved with the (red) positive electrode seeking the polar effect of nervous excitability and conductivity decreased with the current application.~Anode stimulation: Electrical stimulation through the anode or positive pole, in which a peripheral rib will be subjected to the passage of a direct current seeking to reduce excitability and conductivity during the passage of current."
4919|NCT02884427|O1|Outcome|Cathode Stimulation|"Group that is involved with the (black) negative electrode seeking the polar effect of nervous increased excitability and conductivity with the current application.~Cathode stimulation: Electrical stimulation through the cathode or negative pole, in which a peripheral nerve will be subject to the passage of a direct current seeking increased excitability and conductivity during the passage of current."
4920|NCT02884427|O3|Outcome|Control|"Group that will be placed electrotherapy without operation, but only installation. Patients in this group will see the team work but it will not be delivering current.~Placebo: Current application without the actual electric conduction to the person occurs. This will be achieved by adjusting parameters while installing another channel and not one that is working."
4921|NCT02884427|O2|Outcome|Anode Stimulation|"Group that is involved with the (red) positive electrode seeking the polar effect of nervous excitability and conductivity decreased with the current application.~Anode stimulation: Electrical stimulation through the anode or positive pole, in which a peripheral rib will be subjected to the passage of a direct current seeking to reduce excitability and conductivity during the passage of current."
4922|NCT02884427|O1|Outcome|Cathode Stimulation|"Group that is involved with the (black) negative electrode seeking the polar effect of nervous increased excitability and conductivity with the current application.~Cathode stimulation: Electrical stimulation through the cathode or negative pole, in which a peripheral nerve will be subject to the passage of a direct current seeking increased excitability and conductivity during the passage of current."
4923|NCT02884427|E3|Reported Event|Control|"Group that will be placed electrotherapy without operation, but only installation. Patients in this group will see the team work but it will not be delivering current.~Placebo: Current application without the actual electric conduction to the person occurs. This will be achieved by adjusting parameters while installing another channel and not one that is working."
4924|NCT02884427|E2|Reported Event|Anode Stimulation|"Group that is involved with the (red) positive electrode seeking the polar effect of nervous excitability and conductivity decreased with the current application.~Anode stimulation: Electrical stimulation through the anode or positive pole, in which a peripheral rib will be subjected to the passage of a direct current seeking to reduce excitability and conductivity during the passage of current."
4925|NCT02884427|E1|Reported Event|Cathode Stimulation|"Group that is involved with the (black) negative electrode seeking the polar effect of nervous increased excitability and conductivity with the current application.~Cathode stimulation: Electrical stimulation through the cathode or negative pole, in which a peripheral nerve will be subject to the passage of a direct current seeking increased excitability and conductivity during the passage of current."
4926|NCT02882152|B3|Baseline|Total|Total of all reporting groups
4927|NCT02882152|B2|Baseline|Morphine|"intrathecal morphine~morphine: Intrathecal morphine injection"
4928|NCT02882152|B1|Baseline|Femoral Blockade|"femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve~femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery"
4929|NCT02882152|P2|Participant Flow|Morphine|"intrathecal morphine~morphine: Intrathecal morphine injection"
4930|NCT02882152|P1|Participant Flow|Femoral Blockade|"femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve~femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery"
4931|NCT02882152|O2|Outcome|Morphine|"intrathecal morphine~morphine: Intrathecal morphine injection"
4932|NCT02882152|O1|Outcome|Femoral Blockade|"femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve~femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery"
4933|NCT02882152|O2|Outcome|Morphine|"intrathecal morphine~morphine: Intrathecal morphine injection"
4934|NCT02882152|O1|Outcome|Femoral Blockade|"femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve~femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery"
4935|NCT02882152|E2|Reported Event|Morphine|"intrathecal morphine~morphine: Intrathecal morphine injection"
4936|NCT02882152|E1|Reported Event|Femoral Blockade|"femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve~femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery"
4937|NCT02881658|B3|Baseline|Total|Total of all reporting groups
4938|NCT02881658|B2|Baseline|Soya Beverage Provided by Vitasoy|"Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Soya beverage: the placebo product is a 250 ml soya beverage"
4985|NCT02877732|O2|Outcome|Control Subject|EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
4939|NCT02881658|B1|Baseline|Plant Sterols-enriched Soya Beverage Provided by Vitasoy|"Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage"
4940|NCT02881658|P2|Participant Flow|Soya Beverage Provided by Vitasoy|"Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Soya beverage: the placebo product is a 250 ml soya beverage"
4941|NCT02881658|P1|Participant Flow|Plant Sterols-enriched Soya Beverage Provided by Vitasoy|"Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage"
4942|NCT02881658|O2|Outcome|Soya Beverage Provided by Vitasoy|"Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Soya beverage: the placebo product is a 250 ml soya beverage"
4943|NCT02881658|O1|Outcome|Plant Sterols-enriched Soya Beverage Provided by Vitasoy|"Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage"
4944|NCT02881658|O2|Outcome|Soya Beverage Provided by Vitasoy|"Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Soya beverage: the placebo product is a 250 ml soya beverage"
4945|NCT02881658|O1|Outcome|Plant Sterols-enriched Soya Beverage Provided by Vitasoy|"Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage"
4946|NCT02881658|O2|Outcome|Soya Beverage Provided by Vitasoy|"Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Soya beverage: the placebo product is a 250 ml soya beverage"
4947|NCT02881658|O1|Outcome|Plant Sterols-enriched Soya Beverage Provided by Vitasoy|"Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage"
4948|NCT02881658|O2|Outcome|Soya Beverage Provided by Vitasoy|"Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Soya beverage: the placebo product is a 250 ml soya beverage"
4949|NCT02881658|O1|Outcome|Plant Sterols-enriched Soya Beverage Provided by Vitasoy|"Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage"
4950|NCT02881658|O2|Outcome|Soya Beverage Provided by Vitasoy|"Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Soya beverage: the placebo product is a 250 ml soya beverage"
4951|NCT02881658|O1|Outcome|Plant Sterols-enriched Soya Beverage Provided by Vitasoy|"Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage"
4952|NCT02881658|O2|Outcome|Soya Beverage Provided by Vitasoy|"Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Soya beverage: the placebo product is a 250 ml soya beverage"
4953|NCT02881658|O1|Outcome|Plant Sterols-enriched Soya Beverage Provided by Vitasoy|"Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage"
4954|NCT02881658|O2|Outcome|Soya Beverage Provided by Vitasoy|"Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Soya beverage: the placebo product is a 250 ml soya beverage"
4955|NCT02881658|O1|Outcome|Plant Sterols-enriched Soya Beverage Provided by Vitasoy|"Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage"
4956|NCT02881658|O2|Outcome|Soya Beverage Provided by Vitasoy|"Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Soya beverage: the placebo product is a 250 ml soya beverage"
4957|NCT02881658|O1|Outcome|Plant Sterols-enriched Soya Beverage Provided by Vitasoy|"Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage"
4958|NCT02881658|O2|Outcome|Soya Beverage Provided by Vitasoy|"Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Soya beverage: the placebo product is a 250 ml soya beverage"
4986|NCT02877732|O1|Outcome|Concussed Subject|EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
4959|NCT02881658|O1|Outcome|Plant Sterols-enriched Soya Beverage Provided by Vitasoy|"Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage"
4960|NCT02881658|O2|Outcome|Soya Beverage Provided by Vitasoy|"Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Soya beverage: the placebo product is a 250 ml soya beverage"
4961|NCT02881658|O1|Outcome|Plant Sterols-enriched Soya Beverage Provided by Vitasoy|"Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage"
4962|NCT02881658|O2|Outcome|Soya Beverage Provided by Vitasoy|"Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Soya beverage: the placebo product is a 250 ml soya beverage"
4963|NCT02881658|O1|Outcome|Plant Sterols-enriched Soya Beverage Provided by Vitasoy|"Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage"
4964|NCT02881658|O2|Outcome|Soya Beverage Provided by Vitasoy|"Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Soya beverage: the placebo product is a 250 ml soya beverage"
4965|NCT02881658|O1|Outcome|Plant Sterols-enriched Soya Beverage Provided by Vitasoy|"Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage"
4966|NCT02881658|O2|Outcome|Soya Beverage Provided by Vitasoy|Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
4967|NCT02881658|O1|Outcome|Plant Sterols-enriched Soya Beverage Provided by Vitasoy|Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
4968|NCT02881658|O2|Outcome|Soya Beverage Provided by Vitasoy|Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
4969|NCT02881658|O1|Outcome|Plant Sterols-enriched Soya Beverage Provided by Vitasoy|Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
4970|NCT02881658|O2|Outcome|Soya Beverage Provided by Vitasoy|"Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Soya beverage: the placebo product is a 250 ml soya beverage"
4971|NCT02881658|O1|Outcome|Plant Sterols-enriched Soya Beverage Provided by Vitasoy|"Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage"
4972|NCT02881658|E2|Reported Event|Soya Beverage|"Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Soya beverage: the placebo product is a 250 ml soya beverage"
4973|NCT02881658|E1|Reported Event|Plant Sterols-enriched Soya Beverage|"Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage"
4974|NCT02877732|B3|Baseline|Total|Total of all reporting groups
4975|NCT02877732|B2|Baseline|Control Subject|EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
4976|NCT02877732|B1|Baseline|Concussed Subject|EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
4977|NCT02877732|P2|Participant Flow|Control Subject|EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
4978|NCT02877732|P1|Participant Flow|Concussed Subject|EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
4979|NCT02877732|O2|Outcome|Control Subject|EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
4980|NCT02877732|O1|Outcome|Concussed Subject|EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
4981|NCT02877732|O2|Outcome|Control Subject|EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
4982|NCT02877732|O1|Outcome|Concussed Subject|EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
4983|NCT02877732|O2|Outcome|Control Subject|EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
5026|NCT02873429|B2|Baseline|Conventional Medicine Group|Patients receiving conventional medicine care (physical therapy, medication management, injections, etc.) for chronic pain.
4988|NCT02877732|O1|Outcome|Concussed Subject|EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
4989|NCT02877732|O2|Outcome|Control Subject|EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
4990|NCT02877732|O1|Outcome|Concussed Subject|EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
4991|NCT02877732|E2|Reported Event|Control Subject|EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
4992|NCT02877732|E1|Reported Event|Concussed Subject|EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
4993|NCT02877082|B1|Baseline|Tacrolimus, Bortezomib, Thymoglobulin|"Patients receive tacrolimus IV on day -3 through day 180. Patients may receive tacrolimus PO later at the doctor’s discretion. Patients receive thymoglobulin IV on days -3, -2, and -1 and bortezomib IV on day 0 and day 3. Patients undergo allogeneic bone marrow transplant on day 0.~Thymoglobulin: Given IV~Bortezomib: Given IV~Tacrolimus: Given IV and PO"
4994|NCT02877082|P1|Participant Flow|Tacrolimus, Bortezomib, Thymoglobulin|"Patients receive tacrolimus IV on day -3 through day 180. Patients may receive tacrolimus PO later at the doctor’s discretion. Patients receive thymoglobulin IV on days -3, -2, and -1 and bortezomib IV on day 0 and day 3. Patients undergo allogeneic bone marrow transplant on day 0.~Thymoglobulin: Given IV~Bortezomib: Given IV~Tacrolimus: Given IV and PO"
4995|NCT02877082|O1|Outcome|Tacrolimus, Bortezomib, Thymoglobulin|"Patients receive tacrolimus IV on day -3 through day 180. Patients may receive tacrolimus PO later at the doctor’s discretion. Patients receive thymoglobulin IV on days -3, -2, and -1 and bortezomib IV on day 0 and day 3. Patients undergo allogeneic bone marrow transplant on day 0.~Thymoglobulin: Given IV~Bortezomib: Given IV~Tacrolimus: Given IV and PO"
4996|NCT02877082|O1|Outcome|Tacrolimus, Bortezomib, Thymoglobulin|"Patients receive tacrolimus IV on day -3 through day 180. Patients may receive tacrolimus PO later at the doctor’s discretion. Patients receive thymoglobulin IV on days -3, -2, and -1 and bortezomib IV on day 0 and day 3. Patients undergo allogeneic bone marrow transplant on day 0.~Thymoglobulin: Given IV~Bortezomib: Given IV~Tacrolimus: Given IV and PO"
4997|NCT02877082|O1|Outcome|Tacrolimus, Bortezomib, Thymoglobulin|"Patients receive tacrolimus IV on day -3 through day 180. Patients may receive tacrolimus PO later at the doctor’s discretion. Patients receive thymoglobulin IV on days -3, -2, and -1 and bortezomib IV on day 0 and day 3. Patients undergo allogeneic bone marrow transplant on day 0.~Thymoglobulin: Given IV~Bortezomib: Given IV~Tacrolimus: Given IV and PO"
4998|NCT02877082|O1|Outcome|Tacrolimus, Bortezomib, Thymoglobulin|"Patients receive tacrolimus IV on day -3 through day 180. Patients may receive tacrolimus PO later at the doctor’s discretion. Patients receive thymoglobulin IV on days -3, -2, and -1 and bortezomib IV on day 0 and day 3. Patients undergo allogeneic bone marrow transplant on day 0.~Thymoglobulin: Given IV~Bortezomib: Given IV~Tacrolimus: Given IV and PO"
4999|NCT02877082|O1|Outcome|Tacrolimus, Bortezomib, Thymoglobulin|"Patients receive tacrolimus IV on day -3 through day 180. Patients may receive tacrolimus PO later at the doctor’s discretion. Patients receive thymoglobulin IV on days -3, -2, and -1 and bortezomib IV on day 0 and day 3. Patients undergo allogeneic bone marrow transplant on day 0.~Thymoglobulin: Given IV~Bortezomib: Given IV~Tacrolimus: Given IV and PO"
5000|NCT02877082|E1|Reported Event|Tacrolimus, Bortezomib, Thymoglobulin|"Patients receive tacrolimus IV on day -3 through day 180. Patients may receive tacrolimus PO later at the doctor’s discretion. Patients receive thymoglobulin IV on days -3, -2, and -1 and bortezomib IV on day 0 and day 3. Patients undergo allogeneic bone marrow transplant on day 0.~Thymoglobulin: Given IV~Bortezomib: Given IV~Tacrolimus: Given IV and PO"
5001|NCT02876757|B3|Baseline|Total|Total of all reporting groups
5002|NCT02876757|B2|Baseline|Non 5ARI Users|Matched patients without 5ARI usage
5003|NCT02876757|B1|Baseline|5ARI Users|5ARI: Exposure to finasteride/dutasteride
5004|NCT02876757|P2|Participant Flow|Non 5ARI Users|
5005|NCT02876757|P1|Participant Flow|5ARI Users|5ARI: Exposure to finasteride/dutasteride
5006|NCT02876757|O2|Outcome|Non 5ARI Users|
5007|NCT02876757|O1|Outcome|5ARI Users|5ARI: Exposure to finasteride/dutasteride
5008|NCT02876757|O2|Outcome|Non 5ARI Users|
5009|NCT02876757|O1|Outcome|5ARI Users|5ARI: Exposure to finasteride/dutasteride
5010|NCT02876757|O2|Outcome|Non 5ARI Users|
5011|NCT02876757|O1|Outcome|5ARI Users|5ARI: Exposure to finasteride/dutasteride
5012|NCT02876757|E2|Reported Event|Non 5ARI Users|Matched control patients with no exposure to 5ARI
5013|NCT02876757|E1|Reported Event|5ARI Users|5ARI: Exposure to finasteride/dutasteride
5014|NCT02874846|B3|Baseline|Total|Total of all reporting groups
5015|NCT02874846|B2|Baseline|Netarsudil Ophthalmic Solution Vehicle|1 drop in each eye daily (OU) in the evening
5016|NCT02874846|B1|Baseline|Netarsudil Ophthalmic Solution 0.02%|1 drop in each eye daily (OU) in the evening (PM)
5017|NCT02874846|P2|Participant Flow|Netarsudil Ophthalmic Solution Vehicle|1 drop in each eye (OU) daily in the evening (PM)
5018|NCT02874846|P1|Participant Flow|Netarsudil Ophthalmic Solution 0.02%|1 drop in each eye (OU) daily in the evening (PM)
5019|NCT02874846|O2|Outcome|Netarsudil Ophthalmic Solution Vehicle|1 drop in each eye (OU) daily in the evening (PM)
5020|NCT02874846|O1|Outcome|Netarsudil Ophthalmic Solution 0.02%|1 drop in each eye (OU) daily in the evening (PM)
5021|NCT02874846|O2|Outcome|Netarsudil Ophthalmic Solution Vehicle|1 drop in each eye (OU) daily in the evening
5022|NCT02874846|O1|Outcome|Netarsudil Ophthalmic Solution 0.02%|1 drop in each eye (OU) daily in the evening (PM)
5023|NCT02874846|E2|Reported Event|Netarsudil Ophthalmic Solution Vehicle|1 drop in each eye (OU) daily in the evening (PM)
5024|NCT02874846|E1|Reported Event|Netarsudil Ophthalmic Solution 0.02%|1 drop in each eye (OU) daily in the evening (PM)
5025|NCT02873429|B3|Baseline|Total|Total of all reporting groups
5078|NCT02870205|E2|Reported Event|GSP 301 NS|2 sprays/nostril twice daily for 14 days
5028|NCT02873429|P2|Participant Flow|Conventional Medicine Group|Patients receiving conventional medicine care (physical therapy, medication management, injections, etc.) for chronic pain.
5029|NCT02873429|P1|Participant Flow|Integrative Medicine Group|Patients receiving chiropractic care, acupuncture, massage therapy, or meditation training for chronic pain
5030|NCT02873429|O2|Outcome|Conventional Medicine Group|Patients receiving conventional medicine care (physical therapy, medication management, injections, etc.) for chronic pain.
5031|NCT02873429|O1|Outcome|Integrative Medicine Group|Patients receiving chiropractic care, acupuncture, massage therapy, or meditation training for chronic pain
5032|NCT02873429|O2|Outcome|Conventional Medicine Group|Patients receiving conventional medicine care (physical therapy, medication management, injections, etc.) for chronic pain.
5033|NCT02873429|O1|Outcome|Integrative Medicine Group|Patients receiving chiropractic care, acupuncture, massage therapy, or meditation training for chronic pain
5034|NCT02873429|O2|Outcome|Conventional Medicine Group|Patients receiving conventional medicine care (physical therapy, medication management, injections, etc.) for chronic pain.
5035|NCT02873429|O1|Outcome|Integrative Medicine Group|Patients receiving chiropractic care, acupuncture, massage therapy, or meditation training for chronic pain
5036|NCT02873429|E2|Reported Event|Conventional Medicine Group|Patients receiving conventional medicine care (physical therapy, medication management, injections, etc.) for chronic pain.
5037|NCT02873429|E1|Reported Event|Integrative Medicine Group|Patients receiving chiropractic care, acupuncture, massage therapy, or meditation training for chronic pain
5038|NCT02873104|B3|Baseline|Total|Total of all reporting groups
5039|NCT02873104|B2|Baseline|Sham|"truSculpt rf device, non-therapeutic settings~truSculpt rf device: radiofrequency device"
5040|NCT02873104|B1|Baseline|Treatment|"truSculpt rf device, therapeutic settings~truSculpt rf device: radiofrequency device"
5041|NCT02873104|P2|Participant Flow|Sham|"truSculpt rf device, non-therapeutic settings~truSculpt rf device: radiofrequency device"
5042|NCT02873104|P1|Participant Flow|Treatment|"truSculpt rf device, therapeutic settings~truSculpt rf device: radiofrequency device"
5043|NCT02873104|O2|Outcome|Sham|"truSculpt rf device, non-therapeutic settings~truSculpt rf device: radiofrequency device"
5044|NCT02873104|O1|Outcome|Treatment|"truSculpt rf device, therapeutic settings~truSculpt rf device: radiofrequency device"
5045|NCT02873104|O2|Outcome|Sham|"truSculpt rf device, non-therapeutic settings~truSculpt rf device: radiofrequency device"
5046|NCT02873104|O1|Outcome|Treatment|"truSculpt rf device, therapeutic settings~truSculpt rf device: radiofrequency device"
5047|NCT02873104|O2|Outcome|Sham|"truSculpt rf device, non-therapeutic settings~truSculpt rf device: radiofrequency device"
5048|NCT02873104|O1|Outcome|Treatment|"truSculpt rf device, therapeutic settings~truSculpt rf device: radiofrequency device"
5049|NCT02873104|O2|Outcome|Sham|"truSculpt rf device, non-therapeutic settings~truSculpt rf device: radiofrequency device"
5050|NCT02873104|O1|Outcome|Treatment|"truSculpt rf device, therapeutic settings~truSculpt rf device: radiofrequency device"
5051|NCT02873104|E2|Reported Event|Sham|"truSculpt rf device, non-therapeutic settings~truSculpt rf device: radiofrequency device"
5052|NCT02873104|E1|Reported Event|Treatment|"truSculpt rf device, therapeutic settings~truSculpt rf device: radiofrequency device"
5053|NCT02871375|B1|Baseline|Overall|Delefilcon A multifocal contact lenses and subject's habitual multifocal contact lenses worn bilaterally during Period 1 and Period 2 in a crossover assignment.
5054|NCT02871375|P2|Participant Flow|Habitual MF / DT1 MF|Subject's habitual multifocal contact lenses in Period 1, followed by delefilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.
5055|NCT02871375|P1|Participant Flow|DT1 MF / Habitual MF|Delefilcon A multifocal (MF) contact lenses in Period 1, followed by subject's habitual multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.
5056|NCT02871375|O2|Outcome|Habitual MF|Subject's habitual multifocal contact lenses worn bilaterally for 14 ± 3 days in Period 1 and Period 2
5057|NCT02871375|O1|Outcome|DT1 MF|Delefilcon A multifocal contact lenses worn bilaterally for 14 ± 3 days in Period 1 and Period 2
5058|NCT02871375|O2|Outcome|Habitual MF|Subject's habitual multifocal contact lenses worn bilaterally for 14 ± 3 days in Period 1 and Period 2.
5059|NCT02871375|O1|Outcome|DT1 MF|Delefilcon A multifocal contact lenses worn bilaterally for 14 ± 3 days in Period 1 and Period 2
5060|NCT02871375|E3|Reported Event|Habitual MF|Subject's habitual multifocal contact lenses worn bilaterally for 14 ± 3 days in Period 1 and Period 2.
5061|NCT02871375|E2|Reported Event|DT1 MF|Delefilcon A multifocal contact lenses worn bilaterally for 14 ± 3 days in Period 1 and Period 2
5062|NCT02871375|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to exposure to study lenses dispensed for 14-day wear
5063|NCT02870205|B5|Baseline|Total|Total of all reporting groups
5064|NCT02870205|B4|Baseline|Mometasone Furoate NS|2 sprays/nostril twice daily for 14 days
5065|NCT02870205|B3|Baseline|Olopatadine HCl NS|2 sprays/nostril twice daily for 14 days
5066|NCT02870205|B2|Baseline|GSP 301 NS|2 sprays/nostril twice daily for 14 days
5067|NCT02870205|B1|Baseline|GSP 301 Placebo NS|2 sprays/nostril twice daily for 14 days
5068|NCT02870205|P4|Participant Flow|Mometasone Furoate NS|2 sprays/nostril twice daily for 14 days
5069|NCT02870205|P3|Participant Flow|Olopatadine HCl NS|2 sprays/nostril twice daily for 14 days
5070|NCT02870205|P2|Participant Flow|GSP 301 NS|2 sprays/nostril twice daily for 14 days
5071|NCT02870205|P1|Participant Flow|GSP 301 Placebo NS|2 sprays/nostril twice daily for 14 days
5072|NCT02870205|O4|Outcome|Mometasone Furoate NS|2 sprays/nostril twice daily for 14 days
5073|NCT02870205|O3|Outcome|Olopatadine HCl NS|2 sprays/nostril twice daily for 14 days
5074|NCT02870205|O2|Outcome|GSP 301 NS|2 sprays/nostril twice daily for 14 days
5075|NCT02870205|O1|Outcome|GSP 301 Placebo NS|2 sprays/nostril twice daily for 14 days
5076|NCT02870205|E4|Reported Event|Mometasone Furoate NS|2 sprays/nostril twice daily for 14 days
5077|NCT02870205|E3|Reported Event|Olopatadine HCl NS|2 sprays/nostril twice daily for 14 days
5080|NCT02869451|B1|Baseline|Treatment|"Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.~bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.~transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant~Nicotine polacrilex: Initiated at smoking quit date.~nicotine lozenge: Initiated at smoking quit date.~counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention~mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana"
5081|NCT02869451|P1|Participant Flow|Treatment|"Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.~bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.~transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant~Nicotine polacrilex: Initiated at smoking quit date.~nicotine lozenge: Initiated at smoking quit date.~counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention~mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana"
5082|NCT02869451|O1|Outcome|Treatment|"Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.~bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.~transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant~Nicotine polacrilex: Initiated at smoking quit date.~nicotine lozenge: Initiated at smoking quit date.~counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention~mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana"
5083|NCT02869451|O1|Outcome|Treatment|"Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.~bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.~transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant~Nicotine polacrilex: Initiated at smoking quit date.~nicotine lozenge: Initiated at smoking quit date.~counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention~mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana"
5084|NCT02869451|O1|Outcome|Treatment|"Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.~bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.~transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant~Nicotine polacrilex: Initiated at smoking quit date.~nicotine lozenge: Initiated at smoking quit date.~counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention~mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana"
5085|NCT02869451|O1|Outcome|Treatment|"Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.~bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.~transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant~Nicotine polacrilex: Initiated at smoking quit date.~nicotine lozenge: Initiated at smoking quit date.~counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention~mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana"
5086|NCT02869451|O1|Outcome|Treatment|"Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.~bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.~transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant~Nicotine polacrilex: Initiated at smoking quit date.~nicotine lozenge: Initiated at smoking quit date.~counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention~mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana"
5121|NCT02864732|P1|Participant Flow|Stabilization Exercises|"The stabilization exercises program will consist of exercises for the lower back and abdomen. These exercises include various types of abdominal bracing and bridging and side bridging. The exercises will be performed in supine, sidelying, and quadruped. It involves activation of muscles, dissociation of lumbar spine movement from extremities movement and endurance.~Rehabilitation exercises"
5220|NCT02862600|O1|Outcome|Perhexiline--16 Weeks|Subjects completing 8 weeks of perhexiline at target range 100-300 ng/ml, and an additional 8 weeks of perhexiline at target range 300-500 ng/ml.
5087|NCT02869451|O1|Outcome|Treatment|"Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.~bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.~transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant~Nicotine polacrilex: Initiated at smoking quit date.~nicotine lozenge: Initiated at smoking quit date.~counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention~mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana"
5088|NCT02869451|O1|Outcome|Treatment|"Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.~bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.~transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant~Nicotine polacrilex: Initiated at smoking quit date.~nicotine lozenge: Initiated at smoking quit date.~counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention~mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana"
5089|NCT02869451|O1|Outcome|Treatment|"Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.~bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.~transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant~Nicotine polacrilex: Initiated at smoking quit date.~nicotine lozenge: Initiated at smoking quit date.~counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention~mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana"
5090|NCT02869451|O1|Outcome|Treatment|"Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.~bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.~transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant~Nicotine polacrilex: Initiated at smoking quit date.~nicotine lozenge: Initiated at smoking quit date.~counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention~mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana"
5091|NCT02869451|O1|Outcome|Treatment|"Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.~bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.~transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant~Nicotine polacrilex: Initiated at smoking quit date.~nicotine lozenge: Initiated at smoking quit date.~counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention~mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana"
5092|NCT02869451|O1|Outcome|Treatment|"Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.~bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.~transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant~Nicotine polacrilex: Initiated at smoking quit date.~nicotine lozenge: Initiated at smoking quit date.~counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention~mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana"
5093|NCT02869451|O1|Outcome|Treatment|"Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.~bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.~transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant~Nicotine polacrilex: Initiated at smoking quit date.~nicotine lozenge: Initiated at smoking quit date.~counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention~mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana"
5122|NCT02864732|O2|Outcome|Stabilization Exercises Plus Electrical Stimulation|"The neuromuscular electrical stimulation is a hand-size unit that has four plastic adhesive electrical conductors known as electrodes. These electrodes are going to be placed on the skin covering the lower back muscles. They will deliver an electric current that will generate muscle contraction that resembles normal muscle contraction. This treatment will be given in addition to the stabilization exercise program.~Rehabilitation exercises~Electrical Stimulation"
5221|NCT02862600|E1|Reported Event|Perhexiline|All enrolled subjects
5222|NCT02862106|B7|Baseline|Total|Total of all reporting groups
5094|NCT02869451|O1|Outcome|Treatment|"Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.~bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.~transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant~Nicotine polacrilex: Initiated at smoking quit date.~nicotine lozenge: Initiated at smoking quit date.~counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention~mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana"
5095|NCT02869451|O1|Outcome|Treatment|"Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.~bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.~transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant~Nicotine polacrilex: Initiated at smoking quit date.~nicotine lozenge: Initiated at smoking quit date.~counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention~mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana"
5096|NCT02869451|O1|Outcome|Treatment|"Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.~bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.~transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant~Nicotine polacrilex: Initiated at smoking quit date.~nicotine lozenge: Initiated at smoking quit date.~counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention~mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana"
5097|NCT02869451|O1|Outcome|Treatment|"Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.~bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.~transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant~Nicotine polacrilex: Initiated at smoking quit date.~nicotine lozenge: Initiated at smoking quit date.~counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention~mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana"
5098|NCT02869451|O1|Outcome|Treatment|"Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.~bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.~transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant~Nicotine polacrilex: Initiated at smoking quit date.~nicotine lozenge: Initiated at smoking quit date.~counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention~mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana"
5099|NCT02869451|O1|Outcome|Treatment|"Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.~bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.~transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant~Nicotine polacrilex: Initiated at smoking quit date.~nicotine lozenge: Initiated at smoking quit date.~counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention~mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana"
5100|NCT02869451|O1|Outcome|Treatment|"Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.~bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.~transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant~Nicotine polacrilex: Initiated at smoking quit date.~nicotine lozenge: Initiated at smoking quit date.~counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention~mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana"
5123|NCT02864732|O1|Outcome|Stabilization Exercises|"The stabilization exercises program will consist of exercises for the lower back and abdomen. These exercises include various types of abdominal bracing and bridging and side bridging. The exercises will be performed in supine, sidelying, and quadruped. It involves activation of muscles, dissociation of lumbar spine movement from extremities movement and endurance.~Rehabilitation exercises"
5223|NCT02862106|B6|Baseline|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5101|NCT02869451|E1|Reported Event|Treatment|"Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.~bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.~transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant~Nicotine polacrilex: Initiated at smoking quit date.~nicotine lozenge: Initiated at smoking quit date.~counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention~mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana"
5102|NCT02867150|B1|Baseline|Active Device|"Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional~Ward Photonics Photonica Professional: Active Device: Ward Photonics, Photonica Professional Red light therapy system~UltraSlim Cold Light® is the name of a patented treatment regimen using the Photonica Professional device for fat removal using LED red light therapy."
5103|NCT02867150|P1|Participant Flow|Active Device|"Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional~Ward Photonics Photonica Professional: Active Device: Ward Photonics, Photonica Professional Red light therapy system~UltraSlim Cold Light® is the name of a patented treatment regimen using the Photonica Professional device for fat removal using LED red light therapy."
5104|NCT02867150|O1|Outcome|Active Device|"Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional~Ward Photonics Photonica Professional: Active Device: Ward Photonics, Photonica Professional Red light therapy system~UltraSlim Cold Light® is the name of a patented treatment regimen using the Photonica Professional device for fat removal using LED red light therapy."
5105|NCT02867150|E1|Reported Event|Active Device|"Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional~Ward Photonics Photonica Professional: Active Device: Ward Photonics, Photonica Professional Red light therapy system~UltraSlim Cold Light® is the name of a patented treatment regimen using the Photonica Professional device for fat removal using LED red light therapy."
5106|NCT02865083|B3|Baseline|Total|Total of all reporting groups
5107|NCT02865083|B2|Baseline|Standard|Patients will receive use of the standard of care option which is the montgomery straps
5108|NCT02865083|B1|Baseline|Treatment|"Subjects will receive use of the Traxi pannus retractor when undergoing cesarean section~Traxi Pannus Retractor: traxi® Panniculus Retractor is a retraction device used for retraction of the panniculus during surgical procedures. traxi retracts and holds the panniculus for the duration of the operation, freeing the surgeons hands and those of the staff to better care for the patient."
5109|NCT02865083|P2|Participant Flow|Standard|Patients will receive use of the standard of care option which is the montgomery straps
5110|NCT02865083|P1|Participant Flow|Treatment|"Subjects will receive use of the Traxi pannus retractor when undergoing cesarean section~Traxi Pannus Retractor: traxi® Panniculus Retractor is a retraction device used for retraction of the panniculus during surgical procedures. traxi retracts and holds the panniculus for the duration of the operation, freeing the surgeons hands and those of the staff to better care for the patient."
5111|NCT02865083|O2|Outcome|Standard|Patients will receive use of the standard of care option which is the montgomery straps
5112|NCT02865083|O1|Outcome|Treatment|"Subjects will receive use of the Traxi pannus retractor when undergoing cesarean section~Traxi Pannus Retractor: traxi® Panniculus Retractor is a retraction device used for retraction of the panniculus during surgical procedures. traxi retracts and holds the panniculus for the duration of the operation, freeing the surgeons hands and those of the staff to better care for the patient."
5113|NCT02865083|O2|Outcome|Standard|Patients will receive use of the standard of care option which is the montgomery straps
5114|NCT02865083|O1|Outcome|Treatment|"Subjects will receive use of the Traxi pannus retractor when undergoing cesarean section~Traxi Pannus Retractor: traxi® Panniculus Retractor is a retraction device used for retraction of the panniculus during surgical procedures. traxi retracts and holds the panniculus for the duration of the operation, freeing the surgeons hands and those of the staff to better care for the patient."
5115|NCT02865083|E2|Reported Event|Standard|Patients will receive use of the standard of care option which is the montgomery straps
5116|NCT02865083|E1|Reported Event|Treatment|"Subjects will receive use of the Traxi pannus retractor when undergoing cesarean section~Traxi Pannus Retractor: traxi® Panniculus Retractor is a retraction device used for retraction of the panniculus during surgical procedures. traxi retracts and holds the panniculus for the duration of the operation, freeing the surgeons hands and those of the staff to better care for the patient."
5117|NCT02864732|B3|Baseline|Total|Total of all reporting groups
5118|NCT02864732|B2|Baseline|Stabilization Exercises Plus Electrical Stimulation|"The neuromuscular electrical stimulation is a hand-size unit that has four plastic adhesive electrical conductors known as electrodes. These electrodes are going to be placed on the skin covering the lower back muscles. They will deliver an electric current that will generate muscle contraction that resembles normal muscle contraction. This treatment will be given in addition to the stabilization exercise program.~Rehabilitation exercises~Electrical Stimulation"
5119|NCT02864732|B1|Baseline|Stabilization Exercises|"The stabilization exercises program will consist of exercises for the lower back and abdomen. These exercises include various types of abdominal bracing and bridging and side bridging. The exercises will be performed in supine, sidelying, and quadruped. It involves activation of muscles, dissociation of lumbar spine movement from extremities movement and endurance.~Rehabilitation exercises"
5120|NCT02864732|P2|Participant Flow|Stabilization Exercises Plus Electrical Stimulation|"The neuromuscular electrical stimulation is a hand-size unit that has four plastic adhesive electrical conductors known as electrodes. These electrodes are going to be placed on the skin covering the lower back muscles. They will deliver an electric current that will generate muscle contraction that resembles normal muscle contraction. This treatment will be given in addition to the stabilization exercise program.~Rehabilitation exercises~Electrical Stimulation"
5260|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
5124|NCT02864732|O2|Outcome|Stabilization Exercises Plus Electrical Stimulation|"The neuromuscular electrical stimulation is a hand-size unit that has four plastic adhesive electrical conductors known as electrodes. These electrodes are going to be placed on the skin covering the lower back muscles. They will deliver an electric current that will generate muscle contraction that resembles normal muscle contraction. This treatment will be given in addition to the stabilization exercise program.~Rehabilitation exercises~Electrical Stimulation"
5125|NCT02864732|O1|Outcome|Stabilization Exercises|"The stabilization exercises program will consist of exercises for the lower back and abdomen. These exercises include various types of abdominal bracing and bridging and side bridging. The exercises will be performed in supine, sidelying, and quadruped. It involves activation of muscles, dissociation of lumbar spine movement from extremities movement and endurance.~Rehabilitation exercises"
5126|NCT02864732|O2|Outcome|Stabilization Exercises Plus Electrical Stimulation|"The neuromuscular electrical stimulation is a hand-size unit that has four plastic adhesive electrical conductors known as electrodes. These electrodes are going to be placed on the skin covering the lower back muscles. They will deliver an electric current that will generate muscle contraction that resembles normal muscle contraction. This treatment will be given in addition to the stabilization exercise program.~Rehabilitation exercises~Electrical Stimulation"
5127|NCT02864732|O1|Outcome|Stabilization Exercises|"The stabilization exercises program will consist of exercises for the lower back and abdomen. These exercises include various types of abdominal bracing and bridging and side bridging. The exercises will be performed in supine, sidelying, and quadruped. It involves activation of muscles, dissociation of lumbar spine movement from extremities movement and endurance.~Rehabilitation exercises"
5128|NCT02864732|O2|Outcome|Stabilization Exercises Plus Electrical Stimulation|"The neuromuscular electrical stimulation is a hand-size unit that has four plastic adhesive electrical conductors known as electrodes. These electrodes are going to be placed on the skin covering the lower back muscles. They will deliver an electric current that will generate muscle contraction that resembles normal muscle contraction. This treatment will be given in addition to the stabilization exercise program.~Rehabilitation exercises~Electrical Stimulation"
5129|NCT02864732|O1|Outcome|Stabilization Exercises|"The stabilization exercises program will consist of exercises for the lower back and abdomen. These exercises include various types of abdominal bracing and bridging and side bridging. The exercises will be performed in supine, sidelying, and quadruped. It involves activation of muscles, dissociation of lumbar spine movement from extremities movement and endurance.~Rehabilitation exercises"
5130|NCT02864732|O2|Outcome|Stabilization Exercises Plus Electrical Stimulation|"The neuromuscular electrical stimulation is a hand-size unit that has four plastic adhesive electrical conductors known as electrodes. These electrodes are going to be placed on the skin covering the lower back muscles. They will deliver an electric current that will generate muscle contraction that resembles normal muscle contraction. This treatment will be given in addition to the stabilization exercise program.~Rehabilitation exercises~Electrical Stimulation"
5131|NCT02864732|O1|Outcome|Stabilization Exercises|"The stabilization exercises program will consist of exercises for the lower back and abdomen. These exercises include various types of abdominal bracing and bridging and side bridging. The exercises will be performed in supine, sidelying, and quadruped. It involves activation of muscles, dissociation of lumbar spine movement from extremities movement and endurance.~Rehabilitation exercises"
5132|NCT02864732|O1|Outcome|Stabilization Exercises Plus Electrical Stimulation|"The neuromuscular electrical stimulation is a hand-size unit that has four plastic adhesive electrical conductors known as electrodes. These electrodes are going to be placed on the skin covering the lower back muscles. They will deliver an electric current that will generate muscle contraction that resembles normal muscle contraction. This treatment will be given in addition to the stabilization exercise program.~Rehabilitation exercises~Electrical Stimulation"
5133|NCT02864732|E2|Reported Event|Stabilization Exercises Plus Electrical Stimulation|"The neuromuscular electrical stimulation is a hand-size unit that has four plastic adhesive electrical conductors known as electrodes. These electrodes are going to be placed on the skin covering the lower back muscles. They will deliver an electric current that will generate muscle contraction that resembles normal muscle contraction. This treatment will be given in addition to the stabilization exercise program.~Rehabilitation exercises~Electrical Stimulation"
5134|NCT02864732|E1|Reported Event|Stabilization Exercises|"The stabilization exercises program will consist of exercises for the lower back and abdomen. These exercises include various types of abdominal bracing and bridging and side bridging. The exercises will be performed in supine, sidelying, and quadruped. It involves activation of muscles, dissociation of lumbar spine movement from extremities movement and endurance.~Rehabilitation exercises"
5135|NCT02863198|B3|Baseline|Total|Total of all reporting groups
5136|NCT02863198|B2|Baseline|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
5137|NCT02863198|B1|Baseline|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).~endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
5138|NCT02863198|P2|Participant Flow|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
5139|NCT02863198|P1|Participant Flow|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).~endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
5140|NCT02863198|O2|Outcome|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
5218|NCT02862600|O1|Outcome|Perhexiline--16 Weeks|Subjects completing 8 weeks of perhexiline at target range 100-300 ng/ml, and an additional 8 weeks of perhexiline at target range 300-500 ng/ml.
5141|NCT02863198|O1|Outcome|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).~endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
5142|NCT02863198|O2|Outcome|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
5143|NCT02863198|O1|Outcome|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).~endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
5144|NCT02863198|O2|Outcome|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
5145|NCT02863198|O1|Outcome|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).~endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
5146|NCT02863198|O2|Outcome|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
5147|NCT02863198|O1|Outcome|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).~endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
5148|NCT02863198|O2|Outcome|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
5149|NCT02863198|O1|Outcome|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).~endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
5150|NCT02863198|O2|Outcome|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
5151|NCT02863198|O1|Outcome|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).~endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
5152|NCT02863198|E2|Reported Event|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
5153|NCT02863198|E1|Reported Event|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).~endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
5154|NCT02862730|B1|Baseline|All Study Participants|All study participants were randomized to complete four 84 hour study visits using either standard of care insulin pump therapy, dual hormone, single hormone or predictive low glucose suspend closed loop control. Treatment order was randomized.
5155|NCT02862730|P7|Participant Flow|SAP, DH, PLGS, SH|The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), dual hormone (DH), predictive low glucose suspend (PLGS), and single hormone (SH). Each visit was 84 hours and included inpatient and outpatient portions.
5156|NCT02862730|P6|Participant Flow|PLGS, SAP, SH, DH|The randomization order for subjects in this arm was predictive low glucose suspend (PLGS), open loop (Sensor Augmented Pump SAP), single hormone (SH), and dual hormone (DH). Each visit was 84 hours and included inpatient and outpatient portions.
5157|NCT02862730|P5|Participant Flow|PLGS, DH, SH, SAP|The randomization order for subjects in this arm was predictive low glucose suspend (PLGS), dual hormone (DH), single hormone (SH), and open loop (Sensor Augmented Pump SAP). Each visit was 84 hours and included inpatient and outpatient portions.
5158|NCT02862730|P4|Participant Flow|SH, SAP, PLGS, DH|The randomization order for subjects in this arm was single hormone (SH), open loop (Sensor Augmented Pump SAP), predictive low glucose suspend (PLGS) and dual hormone (DH). Each visit was 84 hours and included inpatient and outpatient portions.
5159|NCT02862730|P3|Participant Flow|DH, SH, SAP, PLGS|The randomization order for subjects in this arm was dual hormone (DH), single hormone (SH), open loop (Sensor Augmented Pump SAP), and predictive low glucose suspend (PLGS). Each visit was 84 hours and included inpatient and outpatient portions.
20030|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
5160|NCT02862730|P2|Participant Flow|SAP, DH, SH, PLGS|The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), dual hormone (DH), single hormone (SH) and predictive low glucose suspend (PLGS). Each visit was 84 hours and included inpatient and outpatient portions.
5161|NCT02862730|P1|Participant Flow|SAP, PLGS, DH, SH|The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), predictive low glucose suspend (PLGS), dual hormone (DH) and single hormone (SH). Each visit was 84 hours and included inpatient and outpatient portions.
5162|NCT02862730|O4|Outcome|Sensor Augmented Pump Therapy Arm|"Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.~Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would."
5163|NCT02862730|O3|Outcome|Single Hormone Closed-loop Arm|Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
5164|NCT02862730|O2|Outcome|Predictive Low Glucose Suspend Arm|Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
5165|NCT02862730|O1|Outcome|Dual Hormone Closed Loop|Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon
5166|NCT02862730|O4|Outcome|Sensor Augmented Pump Therapy Arm|"Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.~Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would."
5167|NCT02862730|O3|Outcome|Single Hormone Closed-loop Arm|Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
5168|NCT02862730|O2|Outcome|Dual Hormone Closed-loop Arm|Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon.
5169|NCT02862730|O1|Outcome|Predictive Low Glucose Suspend Arm|Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
5170|NCT02862730|O4|Outcome|Sensor Augmented Pump Therapy Arm|"Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.~Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would."
5171|NCT02862730|O3|Outcome|Single Hormone Closed-loop Arm|Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
5219|NCT02862600|O1|Outcome|Perhexiline--8 Weeks|Subjects completing 8 weeks of perhexiline at target range 100-300 ng/ml.
5806|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
5172|NCT02862730|O2|Outcome|Dual Hormone Closed-loop Arm|Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon.
5173|NCT02862730|O1|Outcome|Predictive Low Glucose Suspend Arm|Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
5174|NCT02862730|O4|Outcome|Sensor Augmented Pump Therapy Arm|"Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.~Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would."
5175|NCT02862730|O3|Outcome|Single Hormone Closed-loop Arm|Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
5176|NCT02862730|O2|Outcome|Dual Hormone Closed-loop Arm|Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon.
5177|NCT02862730|O1|Outcome|Predictive Low Glucose Suspend Arm|Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
5178|NCT02862730|O4|Outcome|Sensor Augmented Pump Therapy Arm|"Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.~Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would."
5179|NCT02862730|O3|Outcome|Single Hormone Closed-loop Arm|Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
5180|NCT02862730|O2|Outcome|Dual Hormone Closed-loop Arm|Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon.
5181|NCT02862730|O1|Outcome|Predictive Low Glucose Suspend Arm|Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
5182|NCT02862730|O4|Outcome|Sensor Augmented Pump Therapy Arm|"Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.~Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would."
5807|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
5183|NCT02862730|O3|Outcome|Single Hormone Closed-loop Arm|Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
5184|NCT02862730|O2|Outcome|Dual Hormone Closed-loop Arm|Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon.
5185|NCT02862730|O1|Outcome|Predictive Low Glucose Suspend Arm|Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
5186|NCT02862730|O4|Outcome|Sensor Augmented Pump Therapy Arm|"Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.~Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would."
5187|NCT02862730|O3|Outcome|Single Hormone Closed-loop Arm|Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
5188|NCT02862730|O2|Outcome|Dual Hormone Closed-loop Arm|Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon.
5189|NCT02862730|O1|Outcome|Predictive Low Glucose Suspend Arm|Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
5190|NCT02862730|O4|Outcome|Sensor Augmented Pump Therapy Arm|"Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.~Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would."
5191|NCT02862730|O3|Outcome|Single Hormone Closed-loop Arm|Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
5192|NCT02862730|O2|Outcome|Dual Hormone Closed-loop Arm|Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon.
5193|NCT02862730|O1|Outcome|Predictive Low Glucose Suspend Arm|Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
5194|NCT02862730|O4|Outcome|Sensor Augmented Pump Therapy Arm|"Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.~Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would."
5195|NCT02862730|O3|Outcome|Single Hormone Closed-loop Arm|Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
5196|NCT02862730|O2|Outcome|Dual Hormone Closed-loop Arm|Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon.
5197|NCT02862730|O1|Outcome|Predictive Low Glucose Suspend Arm|Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
5198|NCT02862730|O4|Outcome|Sensor Augmented Pump Therapy Arm|"Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.~Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would."
5199|NCT02862730|O3|Outcome|Single Hormone Closed-loop Arm|Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
5200|NCT02862730|O2|Outcome|Dual Hormone Closed-loop Arm|Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon.
5201|NCT02862730|O1|Outcome|Predictive Low Glucose Suspend Arm|Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
5202|NCT02862730|O4|Outcome|Sensor Augmented Pump Therapy Arm|"Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.~Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would."
5203|NCT02862730|O3|Outcome|Single Hormone Closed-loop Arm|Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
5204|NCT02862730|O2|Outcome|Dual Hormone Closed-loop Arm|Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon.
5808|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
5205|NCT02862730|O1|Outcome|Predictive Low Glucose Suspend Arm|Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
5206|NCT02862730|O4|Outcome|Sensor Augmented Pump Therapy Arm|"Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.~Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would."
5207|NCT02862730|O3|Outcome|Single Hormone Closed-loop Arm|Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
5208|NCT02862730|O2|Outcome|Dual Hormone Closed-loop Arm|Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled
5209|NCT02862730|O1|Outcome|Predictive Low Glucose Suspend Arm|"The predictive low glucose suspend system will run through the artificial pancreas controller in predictive low glucose suspend mode and utilize the patient’s optimized basal rates, correction factor, and carb ratio, but it will have the additional safety net of the pump suspending insulin when it predicts a hypoglycemic event.~Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery command"
5210|NCT02862730|E5|Reported Event|Tslim Training|Subjects used the tslim and Dexcom G4 Share of G5 sensor for two weeks at home to allow subjects to become familiar with the devices.
5211|NCT02862730|E4|Reported Event|Sensor Augmented Pump Therapy Arm|"Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.~Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would."
5212|NCT02862730|E3|Reported Event|Single Hormone Closed-loop Arm|Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
5213|NCT02862730|E2|Reported Event|Dual Hormone Closed-loop Arm|Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon.
5214|NCT02862730|E1|Reported Event|Predictive Low Glucose Suspend Arm|Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
5215|NCT02862600|B1|Baseline|Perhexiline|"Perhexiline will be administered orally. Dosing will be determined based on plasma level monitoring. For the first 8 week period, the target range will be 100-300 ng/mL, for the second 8 week period, the target range will be 300-500 ng/mL.~Perhexiline: Period 1 (Weeks 1-8) and Period 2 (Weeks 9-16): dose titrated to two different plasma levels of perhexiline~Use of bioanalytical assay to monitor plasma levels of perhexiline: The bioanalytical assay is the device under investigation. It will be used to monitor plasma levels of perhexiline. The data obtained from this analysis will be used to guide dose adjustments of perhexiline."
5216|NCT02862600|P1|Participant Flow|Perhexiline|Perhexiline: Period 1 (Weeks 1-8) and Period 2 (Weeks 9-16): dose titrated to two different plasma levels of perhexiline
5217|NCT02862600|O1|Outcome|Perhexiline--8 Weeks|Subjects completing 8 weeks of perhexiline at target range 100-300 ng/ml
5224|NCT02862106|B5|Baseline|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5225|NCT02862106|B4|Baseline|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5226|NCT02862106|B3|Baseline|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
5227|NCT02862106|B2|Baseline|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
5228|NCT02862106|B1|Baseline|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
5229|NCT02862106|P2|Participant Flow|Follow-up Group|Do not give any intervention, follow-up observation only
5230|NCT02862106|P1|Participant Flow|εPA-44 900μg|"Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128~εPA-44: Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128"
5231|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5232|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5233|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5234|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
5235|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
5236|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
5237|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5238|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5239|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5240|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
5241|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
5242|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
5243|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5244|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5245|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5246|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
5247|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
5248|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
5249|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5250|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5251|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5252|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
5253|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
5254|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
5255|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5256|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5257|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5258|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
5259|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
7083|NCT02780167|O1|Outcome|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
5261|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5262|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from theεPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5263|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5264|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
5265|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
5266|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
5267|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5268|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5269|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5270|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
5271|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
5272|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
5273|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5274|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5275|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5276|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
5277|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
5278|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
5279|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5280|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5281|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
5282|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
5283|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
5284|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
5285|NCT02862106|E2|Reported Event|εPA-44 900μg Group|Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128 All safety analyzes were analyzed in a safe population, and since 5 subjects had no safety data, they were excluded from the safety population
5286|NCT02862106|E1|Reported Event|Follow-up Group|Do not give any intervention, follow-up observation only All safety analyzes were analyzed in a safe population, and since 1 subjects had no safety data, they were excluded from the safety population
5287|NCT02856880|B1|Baseline|All Randomized Participants|All randomized participants were included for baseline evaluation.
5288|NCT02856880|P1|Participant Flow|Overall Study|This was a single-centre, analyst and examiner (plaque sample collector)-blind, randomized, five-treatment, five-period, cross-over study in healthy adult participants. Each participant received each of the five interventions i.e., Test Zinc-isopropylmethylphenol (IPMP), Test Zinc non-IPMP, Positive control, non-sodium lauryl sulphate (SLS) negative control, SLS negative control.
5289|NCT02856880|O5|Outcome|SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150 ppm fluoride as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
5290|NCT02856880|O4|Outcome|Non-SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
5291|NCT02856880|O3|Outcome|Positive Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.454% w/w stannous fluoride (1100 ppm F as stannous fluoride) in 10 mL water for 60 sec followed by rinse with 10 mL water
5292|NCT02856880|O2|Outcome|Test Zinc Non- IPMP|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0% w/w IPMP and 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
5293|NCT02856880|O1|Outcome|Test Zinc-IPMP|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0.1% w/w IPMP and 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
5294|NCT02856880|O5|Outcome|SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150ppm fluoride as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
5295|NCT02856880|O4|Outcome|Non-SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 1426ppm F as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
5296|NCT02856880|O3|Outcome|Positive Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.454% w/w stannous fluoride (1100ppm F as stannous fluoride) in 10mL water for 60 sec followed by rinse with 10mL water
5297|NCT02856880|O2|Outcome|Test Zinc Non- IPMP|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0% w/w IPMP and 1426ppm F as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
5298|NCT02856880|O1|Outcome|Test Zinc-IPMP|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0.1% w/w IPMP and 1426ppm F as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
5299|NCT02856880|O5|Outcome|SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150ppm fluoride as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
5300|NCT02856880|O4|Outcome|Non-SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 1426ppm F as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
5301|NCT02856880|O3|Outcome|Positive Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.454% w/w stannous fluoride (1100ppm F as stannous fluoride) in 10mL water for 60 sec followed by rinse with 10mL water
5302|NCT02856880|O2|Outcome|Test Zinc Non- IPMP|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0% w/w IPMP and 1426ppm F as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
5303|NCT02856880|O1|Outcome|Test Zinc-IPMP|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0.1% w/w IPMP and 1426ppm F as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
5304|NCT02856880|O2|Outcome|Non-SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
5305|NCT02856880|O1|Outcome|Test Zinc-IPMP|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.454% w/w stannous fluoride (1100 ppm F as stannous fluoride) in 10 mL water for 60 sec followed by rinse with 10 mL water
5306|NCT02856880|E5|Reported Event|SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150 ppm fluoride as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
5307|NCT02856880|E4|Reported Event|Non-SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
5308|NCT02856880|E3|Reported Event|Positive Control Toothpaste|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.454% w/w stannous fluoride (1100 ppm F as stannous fluoride) in 10 mL water for 60 sec followed by rinse with 10 mL water
5309|NCT02856880|E2|Reported Event|Test Zinc Non- IPMP Toothpaste|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0% w/w IPMP and 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
5310|NCT02856880|E1|Reported Event|Test Zinc-IPMP Toothpaste|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0.1% w/w IPMP and 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
5311|NCT02855411|B1|Baseline|Overall (PF-04958242/Placebo)|Participants were to take PF-04958242 0.15 milligram (mg), or PF-04958242 0.5 mg, or the matched placebo twice daily (BID) for approximately 85 consecutive days, with the last dose taken in the morning on Day 85.
5312|NCT02855411|P1|Participant Flow|Overall (PF-04958242/Placebo)|Participants were to take PF-04958242 0.15 milligram (mg), or PF-04958242 0.5 mg, or the matched placebo twice daily (BID) for approximately 85 consecutive days, with the last dose taken in the morning on Day 85.
5313|NCT02855411|O1|Outcome|Overall (PF-04958242/Placebo)|Participants were to take PF-04958242 0.15 milligram (mg), or PF-04958242 0.5 mg, or the matched placebo twice daily (BID) for approximately 85 consecutive days, with the last dose taken in the morning on Day 85.
5314|NCT02855411|O1|Outcome|Overall (PF-04958242/Placebo)|Participants were to take PF-04958242 0.15 milligram (mg), or PF-04958242 0.5 mg, or the matched placebo twice daily (BID) for approximately 85 consecutive days, with the last dose taken in the morning on Day 85.
5315|NCT02855411|O1|Outcome|Overall (PF-04958242/Placebo)|Participants were to take PF-04958242 0.15 milligram (mg), or PF-04958242 0.5 mg, or the matched placebo twice daily (BID) for approximately 85 consecutive days, with the last dose taken in the morning on Day 85.
5316|NCT02855411|O1|Outcome|Overall (PF-04958242/Placebo)|Participants were to take PF-04958242 0.15 milligram (mg), or PF-04958242 0.5 mg, or the matched placebo twice daily (BID) for approximately 85 consecutive days, with the last dose taken in the morning on Day 85.
5317|NCT02855411|O1|Outcome|Overall (PF-04958242/Placebo)|Participants were to take PF-04958242 0.15 milligram (mg), or PF-04958242 0.5 mg, or the matched placebo twice daily (BID) for approximately 85 consecutive days, with the last dose taken in the morning on Day 85.
5318|NCT02855411|O1|Outcome|Overall (PF-04958242/Placebo)|Participants were to take PF-04958242 0.15 milligram (mg), or PF-04958242 0.5 mg, or the matched placebo twice daily (BID) for approximately 85 consecutive days, with the last dose taken in the morning on Day 85.
5319|NCT02855411|O1|Outcome|Overall (PF-04958242/Placebo)|Participants were to take PF-04958242 0.15 milligram (mg), or PF-04958242 0.5 mg, or the matched placebo twice daily (BID) for approximately 85 consecutive days, with the last dose taken in the morning on Day 85.
5452|NCT02847169|O3|Outcome|Ocufilcon D Toric Lens (Baseline)|"Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.~ocufilcon D: toric contact lens"
5320|NCT02855411|O1|Outcome|Overall (PF-04958242/Placebo)|Participants were to take PF-04958242 0.15 milligram (mg), or PF-04958242 0.5 mg, or the matched placebo twice daily (BID) for approximately 85 consecutive days, with the last dose taken in the morning on Day 85.
5321|NCT02855411|O1|Outcome|Overall (PF-04958242/Placebo)|Participants were to take PF-04958242 0.15 milligram (mg), or PF-04958242 0.5 mg, or the matched placebo twice daily (BID) for approximately 85 consecutive days, with the last dose taken in the morning on Day 85.
5322|NCT02855411|O1|Outcome|Overall (PF-04958242/Placebo)|Participants were to take PF-04958242 0.15 milligram (mg), or PF-04958242 0.5 mg, or the matched placebo twice daily (BID) for approximately 85 consecutive days, with the last dose taken in the morning on Day 85.
5323|NCT02855411|O1|Outcome|Overall (PF-04958242/Placebo)|Participants were to take PF-04958242 0.15 milligram (mg), or PF-04958242 0.5 mg, or the matched placebo twice daily (BID) for approximately 85 consecutive days, with the last dose taken in the morning on Day 85.
5324|NCT02855411|O1|Outcome|Overall (PF-04958242/Placebo)|Participants were to take PF-04958242 0.15 milligram (mg), or PF-04958242 0.5 mg, or the matched placebo twice daily (BID) for approximately 85 consecutive days, with the last dose taken in the morning on Day 85.
5325|NCT02855411|O1|Outcome|Overall (PF-04958242/Placebo)|Participants were to take PF-04958242 0.15 milligram (mg), or PF-04958242 0.5 mg, or the matched placebo twice daily (BID) for approximately 85 consecutive days, with the last dose taken in the morning on Day 85.
5326|NCT02855411|O1|Outcome|Overall (PF-04958242/Placebo)|Participants were to take PF-04958242 0.15 milligram (mg), or PF-04958242 0.5 mg, or the matched placebo twice daily (BID) for approximately 85 consecutive days, with the last dose taken in the morning on Day 85.
5327|NCT02855411|O1|Outcome|Overall (PF-04958242/Placebo)|Participants were to take PF-04958242 0.15 milligram (mg), or PF-04958242 0.5 mg, or the matched placebo twice daily (BID) for approximately 85 consecutive days, with the last dose taken in the morning on Day 85.
5328|NCT02855411|O1|Outcome|Overall (PF-04958242/Placebo)|Participants were to take PF-04958242 0.15 milligram (mg), or PF-04958242 0.5 mg, or the matched placebo twice daily (BID) for approximately 85 consecutive days, with the last dose taken in the morning on Day 85.
5329|NCT02855411|O1|Outcome|Overall (PF-04958242/Placebo)|Participants were to take PF-04958242 0.15 milligram (mg), or PF-04958242 0.5 mg, or the matched placebo twice daily (BID) for approximately 85 consecutive days, with the last dose taken in the morning on Day 85.
5330|NCT02855411|E1|Reported Event|Overall (PF-04958242/Placebo)|Participants were to take PF-04958242 0.15 milligram (mg), or PF-04958242 0.5 mg, or the matched placebo twice daily (BID) for approximately 85 consecutive days, with the last dose taken in the morning on Day 85.
5331|NCT02855086|B3|Baseline|Total|Total of all reporting groups
5332|NCT02855086|B2|Baseline|Cohort 2 (Cetuximab, Higher Dose Cetuximab-IRDye 800, Surgery)|"Patients receive cetuximab IV over 30 minutes and a higher dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.~All patients undergo standard of care surgical resection of tumor on days 2 to 5.~Cetuximab: Given IV~Cetuximab-IRDye 800CW: Given IV~Conventional Surgery: Undergo tumor resection~Laboratory Biomarker Analysis: Correlative studies"
5333|NCT02855086|B1|Baseline|Cohort 1 (Cetuximab, Lower Dose Cetuximab-IRDye 800, Surgery)|"Patients receive cetuximab IV over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.~All patients undergo standard of care surgical resection of tumor on days 2 to 5.~Cetuximab: Given IV~Cetuximab-IRDye 800CW: Given IV~Conventional Surgery: Undergo tumor resection~Laboratory Biomarker Analysis: Correlative studies"
5334|NCT02855086|P2|Participant Flow|Cohort 2 (Cetuximab, Higher Dose Cetuximab-IRDye 800, Surgery)|"Patients receive cetuximab IV over 30 minutes and a higher dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.~All patients undergo standard of care surgical resection of tumor on days 2 to 5.~Cetuximab: Given IV~Cetuximab-IRDye 800CW: Given IV~Conventional Surgery: Undergo tumor resection~Laboratory Biomarker Analysis: Correlative studies"
5335|NCT02855086|P1|Participant Flow|Cohort 1 (Cetuximab, Lower Dose Cetuximab-IRDye 800, Surgery)|"Patients receive cetuximab IV over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.~All patients undergo standard of care surgical resection of tumor on days 2 to 5.~Cetuximab: Given IV~Cetuximab-IRDye 800CW: Given IV~Conventional Surgery: Undergo tumor resection~Laboratory Biomarker Analysis: Correlative studies"
5336|NCT02855086|O2|Outcome|Cohort 2 (Cetuximab, Higher Dose Cetuximab-IRDye 800, Surgery)|"Patients receive cetuximab IV over 30 minutes and a higher dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.~All patients undergo standard of care surgical resection of tumor on days 2 to 5.~Cetuximab: Given IV~Cetuximab-IRDye 800CW: Given IV~Conventional Surgery: Undergo tumor resection~Laboratory Biomarker Analysis: Correlative studies"
5337|NCT02855086|O1|Outcome|Cohort 1 (Cetuximab, Lower Dose Cetuximab-IRDye 800, Surgery)|"Patients receive cetuximab IV over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.~All patients undergo standard of care surgical resection of tumor on days 2 to 5.~Cetuximab: Given IV~Cetuximab-IRDye 800CW: Given IV~Conventional Surgery: Undergo tumor resection~Laboratory Biomarker Analysis: Correlative studies"
5338|NCT02855086|O2|Outcome|Cohort 2 (Cetuximab, Higher Dose Cetuximab-IRDye 800, Surgery)|"Patients receive cetuximab IV over 30 minutes and a higher dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.~All patients undergo standard of care surgical resection of tumor on days 2 to 5.~Cetuximab: Given IV~Cetuximab-IRDye 800CW: Given IV~Conventional Surgery: Undergo tumor resection~Laboratory Biomarker Analysis: Correlative studies"
5339|NCT02855086|O1|Outcome|Cohort 1 (Cetuximab, Lower Dose Cetuximab-IRDye 800, Surgery)|"Patients receive cetuximab IV over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.~All patients undergo standard of care surgical resection of tumor on days 2 to 5.~Cetuximab: Given IV~Cetuximab-IRDye 800CW: Given IV~Conventional Surgery: Undergo tumor resection~Laboratory Biomarker Analysis: Correlative studies"
5340|NCT02855086|E2|Reported Event|Cohort 2 (Cetuximab, Higher Dose Cetuximab-IRDye 800, Surgery)|"Patients receive cetuximab IV over 30 minutes and a higher dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.~All patients undergo standard of care surgical resection of tumor on days 2 to 5.~Cetuximab: Given IV~Cetuximab-IRDye 800CW: Given IV~Conventional Surgery: Undergo tumor resection~Laboratory Biomarker Analysis: Correlative studies"
5453|NCT02847169|O2|Outcome|Filcon IV1 Toric Lens (Baseline)|"Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.~filcon IV1: toric contact lens"
5341|NCT02855086|E1|Reported Event|Cohort 1 (Cetuximab, Lower Dose Cetuximab-IRDye 800, Surgery)|"Patients receive cetuximab IV over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.~All patients undergo standard of care surgical resection of tumor on days 2 to 5.~Cetuximab: Given IV~Cetuximab-IRDye 800CW: Given IV~Conventional Surgery: Undergo tumor resection~Laboratory Biomarker Analysis: Correlative studies"
5342|NCT02852434|B3|Baseline|Total|Total of all reporting groups
5343|NCT02852434|B2|Baseline|Paracervical Block|"Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement~Lidocaine Paracervical Block (1%)"
5344|NCT02852434|B1|Baseline|Self-administered Gel|"Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure~Lidocaine Gel (2%)"
5345|NCT02852434|P2|Participant Flow|Paracervical Block|"Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement~Lidocaine Paracervical Block (1%)"
5346|NCT02852434|P1|Participant Flow|Self-administered Gel|"Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure~Lidocaine Gel (2%)"
5347|NCT02852434|O2|Outcome|Paracervical Block|"Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement~Lidocaine Paracervical Block (1%)"
5348|NCT02852434|O1|Outcome|Self-administered Gel|"Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure~Lidocaine Gel (2%)"
5349|NCT02852434|O2|Outcome|Paracervical Block|"Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement~Lidocaine Paracervical Block (1%)"
5350|NCT02852434|O1|Outcome|Self-administered Gel|"Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure~Lidocaine Gel (2%)"
5351|NCT02852434|O2|Outcome|Paracervical Block|"Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement~Lidocaine Paracervical Block (1%)"
5352|NCT02852434|O1|Outcome|Self-administered Gel|"Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure~Lidocaine Gel (2%)"
5353|NCT02852434|O2|Outcome|Paracervical Block|"Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement~Lidocaine Paracervical Block (1%)"
5354|NCT02852434|O1|Outcome|Self-administered Gel|"Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure~Lidocaine Gel (2%)"
5355|NCT02852434|O2|Outcome|Paracervical Block|"Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement~Lidocaine Paracervical Block (1%)"
5356|NCT02852434|O1|Outcome|Self-administered Gel|"Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure~Lidocaine Gel (2%)"
5357|NCT02852434|E2|Reported Event|Paracervical Block|"Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement~Lidocaine Paracervical Block (1%)"
5358|NCT02852434|E1|Reported Event|Self-administered Gel|"Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure~Lidocaine Gel (2%)"
5359|NCT02851823|B1|Baseline|Combined Er:YAG+ Nd:YAG Laser Versus Scaling Root Planing|One side (left or right) of the mouth received Er:YAG+Nd:YAG laser therapy (test group) and other side received scaling and root planing with hand instruments (control group)
5360|NCT02851823|P1|Participant Flow|Combined Er:YAG and Nd:YAG Laser vs Scaling and Root Planing|"Combined Er:YAG and Nd:YAG Laser Application Left Side, Scaling and Root Planning Procedure Right Side and Scaling and Root Planning Procedure Left Side, Combined Er:YAG and Nd:YAG Laser Application Right Side"
5361|NCT02851823|O2|Outcome|Test Group|"Combined laser therapy: An Er:YAG laser (160 mj/pulse, 10 Hz) (AT Fidelis Fotona, Ljubljana, Slovenia) with water irrigation was first used to remove subgingival calculus and infected cementum.The Er:YAG laser beam was delivered into the periodontal pockets using a chisel-shaped quartz tip in contact mode under water irrigation, from a coronal to an apical direction with the tip inclined at 10o to 15o to the root surfaces. After Er:YAG laser application, Nd:YAG laser treatment (AT Fidelis Fotona, Ljubljana, Slovenia) was performed at an energy level of 100 mJ/pulse, and 20 Hz for removing pocket epithelium and detoxiﬁcation purpose. Irradiation was accomplished with a 320 μm fiber optic delivery system. The fiber was inserted into the periodontal pocket base in parallel alignment with the root surface, and the fiber was slowly moved from apical to coronal in a sweeping motion during the laser light emission.~Er-YAG+Nd-YAG lasers"
5362|NCT02851823|O1|Outcome|Control Group|"Mechanical periodontal treatment: Scaling and root planing were performed with periodontal curettes until the operator feels that root surface is clean, hard and smooth.~Periodontal curettes"
5363|NCT02851823|O2|Outcome|Test Group|"Combined laser therapy: An Er:YAG laser (160 mj/pulse, 10 Hz) (AT Fidelis Fotona, Ljubljana, Slovenia) with water irrigation was first used to remove subgingival calculus and infected cementum.The Er:YAG laser beam was delivered into the periodontal pockets using a chisel-shaped quartz tip in contact mode under water irrigation, from a coronal to an apical direction with the tip inclined at 10o to 15o to the root surfaces. After Er:YAG laser application, Nd:YAG laser treatment (AT Fidelis Fotona, Ljubljana, Slovenia) was performed at an energy level of 100 mJ/pulse, and 20 Hz for removing pocket epithelium and detoxiﬁcation purpose. Irradiation was accomplished with a 320 μm fiber optic delivery system. The fiber was inserted into the periodontal pocket base in parallel alignment with the root surface, and the fiber was slowly moved from apical to coronal in a sweeping motion during the laser light emission.~Er-YAG+Nd-YAG lasers"
5364|NCT02851823|O1|Outcome|Control Group|"Mechanical periodontal treatment: Scaling and root planing were performed with periodontal curettes until the operator feels that root surface is clean, hard and smooth.~Periodontal curettes"
5415|NCT02847260|O1|Outcome|Remodulin|Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
5365|NCT02851823|E2|Reported Event|Test Group|"Combined laser therapy: An Er:YAG laser (160 mj/pulse, 10 Hz) (AT Fidelis Fotona, Ljubljana, Slovenia) with water irrigation was first used to remove subgingival calculus and infected cementum.The Er:YAG laser beam was delivered into the periodontal pockets using a chisel-shaped quartz tip in contact mode under water irrigation, from a coronal to an apical direction with the tip inclined at 10o to 15o to the root surfaces. After Er:YAG laser application, Nd:YAG laser treatment (AT Fidelis Fotona, Ljubljana, Slovenia) was performed at an energy level of 100 mJ/pulse, and 20 Hz for removing pocket epithelium and detoxiﬁcation purpose. Irradiation was accomplished with a 320 μm fiber optic delivery system. The fiber was inserted into the periodontal pocket base in parallel alignment with the root surface, and the fiber was slowly moved from apical to coronal in a sweeping motion during the laser light emission.~Er-YAG+Nd-YAG lasers"
5366|NCT02851823|E1|Reported Event|Control Group|"Mechanical periodontal treatment: Scaling and root planing were performed with periodontal curettes until the operator feels that root surface is clean, hard and smooth.~Periodontal curettes"
5367|NCT02850159|B3|Baseline|Total|Total of all reporting groups
5368|NCT02850159|B2|Baseline|rTMS Group|"high-frequency rTMS and sham tDCS~rTMS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously"
5369|NCT02850159|B1|Baseline|Dual-mode Group|"the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously~rTMS and tDCS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously"
5370|NCT02850159|P2|Participant Flow|rTMS Group|"high-frequency rTMS and sham tDCS~rTMS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously"
5371|NCT02850159|P1|Participant Flow|Dual-mode Group|"the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously~rTMS and tDCS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously"
5372|NCT02850159|O2|Outcome|rTMS Group|"high-frequency rTMS and sham tDCS~rTMS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously"
5373|NCT02850159|O1|Outcome|Dual-mode Group|"the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously~rTMS and tDCS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously"
5374|NCT02850159|E2|Reported Event|rTMS Group|"high-frequency rTMS and sham tDCS~rTMS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously"
5375|NCT02850159|E1|Reported Event|Dual-mode Group|"the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously~rTMS and tDCS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously"
5376|NCT02849678|B3|Baseline|Total|Total of all reporting groups
5377|NCT02849678|B2|Baseline|Ropivacaine|"Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.~Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years.~Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared."
5378|NCT02849678|B1|Baseline|Lidocaine|"Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.~Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use."
5379|NCT02849678|P2|Participant Flow|Ropivacaine|"Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.~Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years.~Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared."
5443|NCT02847169|O4|Outcome|Filcon IV1 Toric Lens (1 Week)|"Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.~filcon IV1: toric contact lens"
5380|NCT02849678|P1|Participant Flow|Lidocaine|"Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.~Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use."
5381|NCT02849678|O2|Outcome|Ropivacaine|"Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.~Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years.~Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared."
5382|NCT02849678|O1|Outcome|Lidocaine|"Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.~Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use."
5383|NCT02849678|O2|Outcome|Ropivacaine|"Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.~Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years.~Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared."
5384|NCT02849678|O1|Outcome|Lidocaine|"Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.~Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use."
5385|NCT02849678|O2|Outcome|Ropivacaine|"Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.~Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years.~Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared."
5386|NCT02849678|O1|Outcome|Lidocaine|"Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.~Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use."
5387|NCT02849678|O2|Outcome|Ropivacaine|"Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.~Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years.~Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared."
5444|NCT02847169|O3|Outcome|Ocufilcon D Toric Lens (Baseline)|"Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.~ocufilcon D: toric contact lens"
5445|NCT02847169|O2|Outcome|Filcon IV1 Toric Lens (Baseline)|"Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.~filcon IV1: toric contact lens"
5446|NCT02847169|O1|Outcome|Habitual Lens (Baseline)|Habitual lens assessed at baseline.
5388|NCT02849678|O1|Outcome|Lidocaine|"Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.~Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use."
5389|NCT02849678|O2|Outcome|Ropivacaine|"Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.~Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years.~Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared."
5390|NCT02849678|O1|Outcome|Lidocaine|"Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.~Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use."
5391|NCT02849678|O2|Outcome|Ropivacaine|"Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.~Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years.~Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared."
5392|NCT02849678|O1|Outcome|Lidocaine|"Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.~Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use."
5393|NCT02849678|O2|Outcome|Ropivacaine|"Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.~Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years.~Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared."
5394|NCT02849678|O1|Outcome|Lidocaine|"Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.~Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use."
5395|NCT02849678|E2|Reported Event|Ropivacaine|"Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.~Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years.~Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared."
5447|NCT02847169|O3|Outcome|Substantially Decentered|Lens centration
5448|NCT02847169|O2|Outcome|Decentered Slightly|Lens centration
5449|NCT02847169|O1|Outcome|Optimal Centration|Lens centration
5450|NCT02847169|O5|Outcome|Ocufilcon D Toric Lens (1 Week)|"Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.~ocufilcon D: toric contact lens"
20031|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
5396|NCT02849678|E1|Reported Event|Lidocaine|"Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.~Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use."
5397|NCT02848222|B4|Baseline|Total|Total of all reporting groups
5398|NCT02848222|B3|Baseline|Group 3: Twice Daily Application of Warm Washcloth|Ten minute application of a hot-water warmed washcloth in the morning prior to contact lens insertion and ten minute application in the evening after lens removal
5399|NCT02848222|B2|Baseline|Group 2: Once Daily Application of Bruder Compress|Ten minute application of the Bruder Moist Heat Compress in the evening after lens removal
5400|NCT02848222|B1|Baseline|Group 1: Twice Daily Application of Bruder Compress|Ten minute application of the Bruder Moist Heat Compress in the morning prior to contact lens insertion and ten minute application in the evening after lens removal
5401|NCT02848222|P3|Participant Flow|Group 3: Twice Daily Application of Warm Washcloth|Ten minute application of a hot-water warmed washcloth in the morning prior to contact lens insertion and ten minute application in the evening after lens removal
5402|NCT02848222|P2|Participant Flow|Group 2: Once Daily Application of Bruder Compress|Ten minute application of the Bruder Moist Heat Compress in the evening after lens removal
5403|NCT02848222|P1|Participant Flow|Group 1: Twice Daily Application of Bruder Compress|Ten minute application of the Bruder Moist Heat Compress in the morning prior to contact lens insertion and ten minute application in the evening after lens removal
5404|NCT02848222|O3|Outcome|Group 3: Twice Daily Application of Warm Washcloth|Ten minute application of a hot-water warmed washcloth in the morning prior to contact lens insertion and ten minute application in the evening after lens removal
5405|NCT02848222|O2|Outcome|Group 2: Once Daily Application of Bruder Compress|Ten minute application of the Bruder Moist Heat Compress in the evening after lens removal
5406|NCT02848222|O1|Outcome|Group 1: Twice Daily Application of Bruder Compress|Ten minute application of the Bruder Moist Heat Compress in the morning prior to contact lens insertion and ten minute application in the evening after lens removal
5407|NCT02848222|E3|Reported Event|Group 3: Twice Daily Application of Warm Washcloth|Ten minute application of a hot-water warmed washcloth in the morning prior to contact lens insertion and ten minute application in the evening after lens removal
5408|NCT02848222|E2|Reported Event|Group 2: Once Daily Application of Bruder Compress|Ten minute application of the Bruder Moist Heat Compress in the evening after lens removal
5409|NCT02848222|E1|Reported Event|Group 1: Twice Daily Application of Bruder Compress|Ten minute application of the Bruder Moist Heat Compress in the morning prior to contact lens insertion and ten minute application in the evening after lens removal
5410|NCT02847260|B1|Baseline|Remodulin|Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
5411|NCT02847260|P1|Participant Flow|Remodulin|Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
5412|NCT02847260|O1|Outcome|Remodulin|Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
5413|NCT02847260|O1|Outcome|Remodulin|Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
5414|NCT02847260|O1|Outcome|Remodulin|Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
5451|NCT02847169|O4|Outcome|Filcon IV1 Toric Lens (1 Week)|"Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.~filcon IV1: toric contact lens"
5454|NCT02847169|O1|Outcome|Habitual Lens (Baseline)|Habitual data was assessed at baseline.
5416|NCT02847260|O1|Outcome|Remodulin|Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
5417|NCT02847260|O1|Outcome|Remodulin|Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
5418|NCT02847260|O1|Outcome|Remodulin|Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
5419|NCT02847260|O1|Outcome|Remodulin|Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
5420|NCT02847260|O1|Outcome|Remodulin|Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
5421|NCT02847260|E1|Reported Event|Remodulin|Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
5422|NCT02847169|B1|Baseline|Overall Participants|"Participants are randomized to wear filcon IV1 or ocufilcon D toric lens pair for 1 week during the cross over study.~filcon IV1: toric contact lens~ocufilcon D: toric contact lens"
5423|NCT02847169|P2|Participant Flow|Ocufilcon D Toric Lens, Then Filcon IV1 Toric Lens|"Participants are randomized to wear ocufilcon D toric lens, then filcon IV1 lens pair for 1 week each during the cross over study.~filcon IV1: toric contact lens~ocufilcon D: toric contact lens"
5424|NCT02847169|P1|Participant Flow|Filcon IV1 Toric Lens, Then Ocufilcon D Toric Lens|"Participants are randomized to wear filcon IV1 toric lens, then ocufilcon D toric lens pair for 1 week each during the cross over study.~filcon IV1: toric contact lens~ocufilcon D: toric contact lens"
5425|NCT02847169|O5|Outcome|Ocufilcon D Toric Lens (1 Week)|Data collected at 1 week for ocufilcon D toric lens.
5426|NCT02847169|O4|Outcome|Filcon IV1 Toric Lens (1 Week)|Data collected at 1 week for filcon IV1 toric lens.
5427|NCT02847169|O3|Outcome|Ocufilcon D Toric Lens (Baseline)|Data collected at baseline for ocufilcon D toric lens.
5428|NCT02847169|O2|Outcome|Filcon IV1 Toric Lens (Baseline)|Data collected at baseline for filcon IV1 toric lens.
5429|NCT02847169|O1|Outcome|Habitual Toric Lens|Habitual data was gathered at baseline.
5430|NCT02847169|O5|Outcome|Ocufilcon D Toric Lens (1 Week)|Data collected at 1 week for ocufilcon D toric lens.
5431|NCT02847169|O4|Outcome|Filcon IV1 Toric Lens (1 Week)|Data collected at 1 week for filcon IV1 toric lens.
5432|NCT02847169|O3|Outcome|Ocufilcon D Toric Lens (Baseline)|Data collected at baseline for ocufilcon D toric lens.
5433|NCT02847169|O2|Outcome|Filcon IV1 Toric Lens (Baseline)|Data collected at baseline for filcon IV1 toric lens.
5434|NCT02847169|O1|Outcome|Habitual Toric Lens|Habitual data was gathered at baseline.
5435|NCT02847169|O2|Outcome|Ocufilcon D Toric Lens|"Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.~ocufilcon D: toric contact lens"
5436|NCT02847169|O1|Outcome|Filcon IV1 Toric Lens|"Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.~filcon IV1: toric contact lens"
5437|NCT02847169|O5|Outcome|Ocufilcon D Toric Lens (1 Week)|Data collected at 1 week for ocufilcon D toric lens.
5438|NCT02847169|O4|Outcome|Filcon IV1 Toric Lens (1 Week)|Data collected at 1 week for filcon IV1 toric lens.
5439|NCT02847169|O3|Outcome|Ocufilcon D Toric Lens (Baseline)|Data collected at baseline for ocufilcon D toric lens.
5440|NCT02847169|O2|Outcome|Filcon IV1 Toric Lens (Baseline)|Data collected at baseline for filcon IV1 toric lens.
5441|NCT02847169|O1|Outcome|Habitual Toric Lens|Habitual data was assessed at baseline.
5442|NCT02847169|O5|Outcome|Ocufilcon D Toric Lens (1 Week)|"Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.~ocufilcon D: toric contact lens"
7584|NCT02759692|O2|Outcome|Stenfilcon A|Subjects that received the stenfilcon A lens during any three of the study periods.
5455|NCT02847169|E2|Reported Event|Ocufilcon D Toric Lens|"Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.~ocufilcon D toric lens: toric contact lens"
5456|NCT02847169|E1|Reported Event|Filcon IV1 Toric Lens|"Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.~filcon IV1 toric lens: toric contact lens"
5457|NCT02844998|B4|Baseline|Total|Total of all reporting groups
5458|NCT02844998|B3|Baseline|Sham-controlled|"Patients who have sedentary life style will be advised those to walk at most 30 minutes for 5 days in a week.~physical activity: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week"
5459|NCT02844998|B2|Baseline|Group 2|"Patients who have sedentary life style will be advised moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week~physical activity: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week"
5460|NCT02844998|B1|Baseline|Group 1|"Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand)~dapoxetine 30 mg on demand: Dapoxetine, a short-acting selective serotonin reuptake inhibitors, has been utilized for the treatment of premature ejaculation in various countries"
5461|NCT02844998|P3|Participant Flow|Sham-controlled|"Patients who have sedentary life style will be advised those to walk at most 30 minutes for 5 days in a week.~physical activity: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week. (inactive category [<600 MET-min/week] according to the IPAQ classification)"
5462|NCT02844998|P2|Participant Flow|Group 2|"Patients who have sedentary life style will be advised moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week.~Physical activity: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week (To increase the physical activity level to “minimally active category or moderate physical activities [600-3,000 MET-min/week] according to IPAQ classification)"
5463|NCT02844998|P1|Participant Flow|Group 1|"Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand)~dapoxetine 30 mg on demand: Dapoxetine, a short-acting selective serotonin reuptake inhibitors, has been utilized for the treatment of premature ejaculation in various countries"
5464|NCT02844998|O3|Outcome|Sham-controlled|"Patients who have sedentary life style will be advised those to walk at most 30 minutes for 5 days in a week.~physical activity: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week. (inactive category [<600 MET-min/week] according to the IPAQ classification)"
5465|NCT02844998|O2|Outcome|Group 2|"Patients who have sedentary life style will be advised moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week.~Physical activity: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week (To increase the physical activity level to “minimally active category or moderate physical activities [600-3,000 MET-min/week] according to IPAQ classification)"
5466|NCT02844998|O1|Outcome|Group 1|"Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand)~dapoxetine 30 mg on demand: Dapoxetine, a short-acting selective serotonin reuptake inhibitors, has been utilized for the treatment of premature ejaculation in various countries"
5467|NCT02844998|O3|Outcome|Sham-controlled|"Patients who have sedentary life style will be advised those to walk at most 30 minutes for 5 days in a week.~physical activity: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week. (inactive category [<600 MET-min/week] according to the IPAQ classification)"
5468|NCT02844998|O2|Outcome|Group 2|"Patients who have sedentary life style will be advised moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week.~Physical activity: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week (To increase the physical activity level to “minimally active category or moderate physical activities [600-3,000 MET-min/week] according to IPAQ classification)"
5469|NCT02844998|O1|Outcome|Group 1|"Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand)~dapoxetine 30 mg on demand: Dapoxetine, a short-acting selective serotonin reuptake inhibitors, has been utilized for the treatment of premature ejaculation in various countries"
5470|NCT02844998|E3|Reported Event|Sham-controlled|"Patients who have sedentary life style will be advised those to walk at most 30 minutes for 5 days in a week.~physical activity: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week"
5471|NCT02844998|E2|Reported Event|Group 2|"Patients who have sedentary life style will be advised moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week~physical activity: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week"
5472|NCT02844998|E1|Reported Event|Group 1|"Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand)~dapoxetine 30 mg on demand: Dapoxetine, a short-acting selective serotonin reuptake inhibitors, has been utilized for the treatment of premature ejaculation in various countries"
5473|NCT02844543|B1|Baseline|Athletes|Participants were tested with the EYE-SYNC eye-tracking device, the Desktop Eye-tracker, and SCAT-3 Symptom subtest.
5474|NCT02844543|P1|Participant Flow|Athletes|Participants were tested with the EYE-SYNC eye-tracking device, the Desktop Eye-tracker, and SCAT-3 Symptom subtest.
5475|NCT02844543|O1|Outcome|Athletes|Participants were tested with the EYE-SYNC eye-tracking device, the Desktop Eye-tracker, and SCAT-3 Symptom subtest.
5476|NCT02844543|O1|Outcome|Athletes|Participants were tested with the EYE-SYNC eye-tracking device, the Desktop Eye-tracker, and SCAT-3 Symptom subtest.
5477|NCT02844543|O1|Outcome|Athletes|Participants were tested with the EYE-SYNC eye-tracking device, the Desktop Eye-tracker, and SCAT-3 Symptom subtest.
5478|NCT02844543|O1|Outcome|Athletes|Participants were tested with the EYE-SYNC eye-tracking device, the Desktop Eye-tracker, and SCAT-3 Symptom subtest.
5479|NCT02844543|E1|Reported Event|Athletes|Participants were tested with the EYE-SYNC eye-tracking device, the Desktop Eye-tracker, and SCAT-3 Symptom subtest.
5480|NCT02840916|B3|Baseline|Total|Total of all reporting groups
5481|NCT02840916|B2|Baseline|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)~sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
5482|NCT02840916|B1|Baseline|Verum Laser Acupuncture|"verum laser acupuncture~laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
5483|NCT02840916|P2|Participant Flow|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)~sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
5484|NCT02840916|P1|Participant Flow|Verum Laser Acupuncture|"verum laser acupuncture~laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
5485|NCT02840916|O2|Outcome|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)~sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
5486|NCT02840916|O1|Outcome|Verum Laser Acupuncture|"verum laser acupuncture~laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
5487|NCT02840916|O2|Outcome|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)~sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
5488|NCT02840916|O1|Outcome|Verum Laser Acupuncture|"verum laser acupuncture~laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
5489|NCT02840916|O2|Outcome|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)~sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
5490|NCT02840916|O1|Outcome|Verum Laser Acupuncture|"verum laser acupuncture~laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
5491|NCT02840916|E2|Reported Event|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)~sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
5492|NCT02840916|E1|Reported Event|Verum Laser Acupuncture|"verum laser acupuncture~laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
5493|NCT02839772|B3|Baseline|Total|Total of all reporting groups
5494|NCT02839772|B2|Baseline|Current Skin Regimen Plus 2% Glycerine|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
5495|NCT02839772|B1|Baseline|Current Skin Care Regimen|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
5496|NCT02839772|P2|Participant Flow|Current Skin Regimen Plus 2% Glycerine|Legs/feet washed daily for 3 months with soapy water, soaked in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and splashed up the lower legs with the hands for 30 mins, then air dried, a thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
5497|NCT02839772|P1|Participant Flow|Current Skin Care Regimen|Legs/feet washed daily for 3 months with soapy water, soaked in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%) and splashed up the lower legs with the hands for 30 mins, then air dried, a thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
5498|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
5499|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
5500|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
5501|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
5502|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
5503|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
5504|NCT02839772|O1|Outcome|Correlation Between Number of Wounds and Days Lost Due to ADL|Correlation between nuumber of work days lost in previous month due to ADL and number of wounds (all skin breaches including areas of fungal infection)
5505|NCT02839772|O2|Outcome|Number of Days Lost by All Participants at 4th Visit|Number of days work lost in previous month due to adeno-lymphangitis. Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
5506|NCT02839772|O1|Outcome|Number of Days Work Days Lost by All Participants Baseline|Number of days work lost in previous month due to adeno-lymphangitis. Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
5507|NCT02839772|O2|Outcome|Number of Wounds 4th Visit|The total number of wounds (skin breaches including areas of fungal infection) of all participants on all legs/feet at 4th visit.
5508|NCT02839772|O1|Outcome|Number of Wounds at Baseline|The total number of wounds (skin breaches including areas of fungal infection) of all participants on all legs/feet at baseline.
5509|NCT02839772|O2|Outcome|Participants With Bad Odour From Legs/Feet at 4th Visit|Presence of a bad odour emanating from legs/feet of all participants as determined by clinic nurse.
5510|NCT02839772|O1|Outcome|Participants With Bad Odour From Legs/Feet at Baseline|Presence of a bad odour emanating from legs/feet of all participants as determined by clinic nurse.
5511|NCT02839772|O2|Outcome|Total Number of Trophic Skin Changes at 4th Visit|Trophic (mossy) skin changes on the lower legs/feet are a characteristic of podoconiosis. The total number of all participants with trophic changes in their lower legs/feet is reported. A reduction in the number of legs/feet with mossy changes would denote an improvement in the condition.
5512|NCT02839772|O1|Outcome|Total Number of Trophic Skin Changes at Baseline|Trophic (mossy) skin changes on the lower legs/feet are a characteristic of podoconiosis. The total number of all participants with trophic changes in their lower legs/feet is reported.
5513|NCT02839772|O2|Outcome|Stage of Podoconiosis 4th Visit|The number of legs with each stage of podoconiosis (1-5) and those with no disease
5514|NCT02839772|O1|Outcome|Stage of Podoconiosis 1st Visit|The number of legs with each stage of podoconiosis (1-5) and those with no disease
5515|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
5516|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
5517|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
5518|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
5519|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
5520|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
5521|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
5522|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
5523|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
5524|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
5525|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
5624|NCT02834624|O2|Outcome|Calfactant|Randomized to receive calfactant (Infasurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
5526|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
5527|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
5528|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
5529|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
5530|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
5531|NCT02839772|E2|Reported Event|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soaked in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and splashed up the lower legs with the hands for 30 mins, then air dried, a thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
5532|NCT02839772|E1|Reported Event|Control Group|Legs/feet washed daily for 3 months with soapy water, soaked in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%) and splashed up the lower legs with the hands for 30 mins, then air dried, a thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
5533|NCT02838901|B3|Baseline|Total|Total of all reporting groups
5534|NCT02838901|B2|Baseline|Beet It Beetroot Juice Placebo|"70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.~Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice."
5535|NCT02838901|B1|Baseline|Beet It Beetroot Juice|"70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.~Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle"
5536|NCT02838901|P2|Participant Flow|Beet It Beetroot Juice Placebo|"70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.~Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.~Nine participants were randomized to the Beet It Beetroot Juice Placebo arm. Participants had blood drawn on study day 1 and day 30 for nitrate and nitrite levels before and one hour after drinking 70 cc (3.8 mM nitrate) plus vitamin C 500 mg daily. On day 30, gait speed (using the 4 m walk) was assessed.~Eighteen participants were consented, 15 completed treatment (1 terminated treatment because of nausea), 16 followed for 30 days and 13 for 90 days.~Participants selected for the MRI portion of the study had a brain MRI performed on study day 30 to measure cerebral b"
5537|NCT02838901|P1|Participant Flow|Beet It Beetroot Juice|"70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.~Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle.~Nine participants were randomized to the Beet It Beetroot Juice arm. Participants had blood drawn on study day 1 and day 30 for nitrate and nitrite levels before and one hour after drinking 70 cc (3.8 mM nitrate) plus vitamin C 500 mg daily. On day 30, gait speed (using the 4 m walk) was assessed.~Eighteen participants were consented, 15 completed treatment (1 terminated treatment because of nausea), 16 followed for 30 days and 13 for 90 days.~Participants selected for the MRI portion of the study had a brain MRI performed on study day 30 to measure cerebral blood flow."
5538|NCT02838901|O2|Outcome|Beet It Beetroot Juice Placebo|"70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.~Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice."
5539|NCT02838901|O1|Outcome|Beet It Beetroot Juice|"70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.~Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle"
5540|NCT02838901|O2|Outcome|Beet It Beetroot Juice Placebo|"70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.~Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice."
5541|NCT02838901|O1|Outcome|Beet It Beetroot Juice|"70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.~Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle"
5542|NCT02838901|O2|Outcome|Beet It Beetroot Juice Placebo|"70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.~Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice."
5543|NCT02838901|O1|Outcome|Beet It Beetroot Juice|"70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.~Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle"
5544|NCT02838901|O2|Outcome|Beet It Beetroot Juice Placebo|"70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.~Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice."
5545|NCT02838901|O1|Outcome|Beet It Beetroot Juice|"70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.~Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle"
5546|NCT02838901|O2|Outcome|Beet It Beetroot Juice Placebo|"70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.~Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice."
5547|NCT02838901|O1|Outcome|Beet It Beetroot Juice|"70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.~Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle"
5548|NCT02838901|O2|Outcome|Beet It Beetroot Juice Placebo|"70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.~Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice."
5549|NCT02838901|O1|Outcome|Beet It Beetroot Juice|"70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.~Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle"
5550|NCT02838901|O2|Outcome|Beet It Beetroot Juice Placebo|"70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.~Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice."
5551|NCT02838901|O1|Outcome|Beet It Beetroot Juice|"70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.~Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle"
5552|NCT02838901|O2|Outcome|Beet It Beetroot Juice Placebo|"70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.~Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice."
5553|NCT02838901|O1|Outcome|Beet It Beetroot Juice|"70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.~Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle"
5554|NCT02838901|O2|Outcome|Beet It Beetroot Juice Placebo|"70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.~Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice."
5555|NCT02838901|O1|Outcome|Beet It Beetroot Juice|"70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.~Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle"
5556|NCT02838901|O2|Outcome|Beet It Beetroot Juice Placebo|"70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.~Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice."
5557|NCT02838901|O1|Outcome|Beet It Beetroot Juice|"70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.~Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle"
5558|NCT02838901|O2|Outcome|Beet It Beetroot Juice Placebo|"70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.~Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.~Nine participants were randomized to the Beet It Beetroot Juice Placebo arm. Participants had blood drawn on study day 1 and day 30 for nitrate and nitrite levels before and one hour after drinking 70 cc (3.8 mM nitrate) plus vitamin C 500 mg daily. On day 30, gait speed (using the 4 m walk) was assessed.~Eighteen participants were consented, 15 completed treatment (1 terminated treatment because of nausea), 16 followed for 30 days and 13 for 90 days.~Participants selected for the MRI portion of the study had a brain MRI performed on study day 30 to measure cerebral b"
5559|NCT02838901|O1|Outcome|Beet It Beetroot Juice|"70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.~Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle.~Nine participants were randomized to the Beet It Beetroot Juice arm. Participants had blood drawn on study day 1 and day 30 for nitrate and nitrite levels before and one hour after drinking 70 cc (3.8 mM nitrate) plus vitamin C 500 mg daily. On day 30, gait speed (using the 4 m walk) was assessed.~Eighteen participants were consented, 15 completed treatment (1 terminated treatment because of nausea), 16 followed for 30 days and 13 for 90 days.~Participants selected for the MRI portion of the study had a brain MRI performed on study day 30 to measure cerebral blood flow."
7585|NCT02759692|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A lens during any of the three study periods.
5560|NCT02838901|O2|Outcome|Beet It Beetroot Juice Placebo|"70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.~Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice."
5561|NCT02838901|O1|Outcome|Beet It Beetroot Juice|"70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.~Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle"
5562|NCT02838901|E2|Reported Event|Beet It Beetroot Juice Placebo|"70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.~Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice."
5563|NCT02838901|E1|Reported Event|Beet It Beetroot Juice|"70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.~Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle"
5564|NCT02837952|B3|Baseline|Total|Total of all reporting groups
5565|NCT02837952|B2|Baseline|Ibuprofen 250 mg / Acetaminophen 500 mg|Participants received fixed dose combination of IBU 250 mg/ APAP 500 mg (administered as 2 tablets of IBU 125 mg/APAP 250 mg) within 7 minutes of the completion of baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
5566|NCT02837952|B1|Baseline|Placebo|Participants received placebo matched to fixed dose combination of ibuprofen (IBU) / acetaminophen (APAP) (administered as 2 tablets) within 7 minutes of the completion of Baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
5567|NCT02837952|P2|Participant Flow|Ibuprofen 250 mg / Acetaminophen 500 mg|Participants received fixed dose combination of IBU 250 mg/ APAP 500 mg (administered as 2 tablets of IBU 125 mg/APAP 250 mg) within 7 minutes of the completion of baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
5568|NCT02837952|P1|Participant Flow|Placebo|Participants received placebo matched to fixed dose combination of ibuprofen (IBU) / acetaminophen (APAP) (administered as 2 tablets) within 7 minutes of the completion of Baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
5569|NCT02837952|O2|Outcome|Ibuprofen 250 mg / Acetaminophen 500|Participants received fixed dose combination of IBU 250 mg/ APAP 500 mg (administered as 2 tablets of IBU 125 mg/APAP 250 mg) within 7 minutes of the completion of baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
5570|NCT02837952|O1|Outcome|Placebo|Participants received placebo matched to fixed dose combination of ibuprofen (IBU) / acetaminophen (APAP) (administered as 2 tablets) within 7 minutes of the completion of Baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
5571|NCT02837952|O2|Outcome|Ibuprofen 250 mg / Acetaminophen 500|Participants received fixed dose combination of IBU 250 mg/ APAP 500 mg (administered as 2 tablets of IBU 125 mg/APAP 250 mg) within 7 minutes of the completion of baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
5572|NCT02837952|O1|Outcome|Placebo|Participants received placebo matched to fixed dose combination of ibuprofen (IBU) / acetaminophen (APAP) (administered as 2 tablets) within 7 minutes of the completion of Baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
5573|NCT02837952|O2|Outcome|Ibuprofen 250 mg / Acetaminophen 500|Participants received fixed dose combination of IBU 250 mg/ APAP 500 mg (administered as 2 tablets of IBU 125 mg/APAP 250 mg) within 7 minutes of the completion of baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
5574|NCT02837952|O1|Outcome|Placebo|Participants received placebo matched to fixed dose combination of ibuprofen (IBU) / acetaminophen (APAP) (administered as 2 tablets) within 7 minutes of the completion of Baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
5575|NCT02837952|O2|Outcome|Ibuprofen 250 mg / Acetaminophen 500|Participants received fixed dose combination of IBU 250 mg/ APAP 500 mg (administered as 2 tablets of IBU 125 mg/APAP 250 mg) within 7 minutes of the completion of baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
5576|NCT02837952|O1|Outcome|Placebo|Participants received placebo matched to fixed dose combination of ibuprofen (IBU) / acetaminophen (APAP) (administered as 2 tablets) within 7 minutes of the completion of Baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
5577|NCT02837952|E2|Reported Event|Ibuprofen 250 mg / Acetaminophen 500 mg|Participants received fixed dose combination of IBU 250 mg/ APAP 500 mg (administered as 2 tablets of IBU 125 mg/APAP 250 mg) within 7 minutes of the completion of baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
7586|NCT02759692|E2|Reported Event|Stenfilcon A|Subjects that received the stenfilcon A lens during any three of the study periods.
5578|NCT02837952|E1|Reported Event|Placebo|Participants received placebo matched to fixed dose combination of ibuprofen (IBU) / acetaminophen (APAP) (administered as 2 tablets) within 7 minutes of the completion of Baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
5579|NCT02836249|B3|Baseline|Total|Total of all reporting groups
5580|NCT02836249|B2|Baseline|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 144 weeks
5581|NCT02836249|B1|Baseline|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 144 weeks
5582|NCT02836249|P2|Participant Flow|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 144 weeks
5583|NCT02836249|P1|Participant Flow|TAF 25 mg|Tenofovir alafenamide (TAF) 25 mg tablet + tenofovir disoproxil fumarate (TDF) placebo tablet once daily for up to 144 weeks
5584|NCT02836249|O2|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 144 weeks
5585|NCT02836249|O1|Outcome|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 144 weeks
5586|NCT02836249|O2|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 144 weeks
5587|NCT02836249|O1|Outcome|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 144 weeks
5588|NCT02836249|O2|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 144 weeks
5589|NCT02836249|O1|Outcome|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 144 weeks
5590|NCT02836249|O2|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 144 weeks
5591|NCT02836249|O1|Outcome|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 144 weeks
5592|NCT02836249|O2|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 144 weeks
5593|NCT02836249|O1|Outcome|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 144 weeks
5594|NCT02836249|O2|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 144 weeks
5595|NCT02836249|O1|Outcome|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 144 weeks
5596|NCT02836249|E2|Reported Event|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 144 weeks
5597|NCT02836249|E1|Reported Event|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 144 weeks
5598|NCT02836236|B3|Baseline|Total|Total of all reporting groups
5599|NCT02836236|B2|Baseline|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 144 weeks
5600|NCT02836236|B1|Baseline|TAF 25 mg|TAF 25 mg + TDF placebo tablets administered once daily for up to 144 weeks
5601|NCT02836236|P2|Participant Flow|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 144 weeks
5602|NCT02836236|P1|Participant Flow|TAF 25 mg|Tenofovir alafenamide (TAF) 25 mg + tenofovir disoproxil fumarate (TDF) placebo tablets administered once daily for up to 144 weeks
5603|NCT02836236|O2|Outcome|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 144 weeks
5604|NCT02836236|O1|Outcome|TAF 25 mg|TAF 25 mg + TDF placebo tablets administered once daily for up to 144 weeks
5605|NCT02836236|O2|Outcome|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 144 weeks
5606|NCT02836236|O1|Outcome|TAF 25 mg|TAF 25 mg + TDF placebo tablets administered once daily for up to 144 weeks
5607|NCT02836236|O2|Outcome|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 144 weeks
5608|NCT02836236|O1|Outcome|TAF 25 mg|TAF 25 mg + TDF placebo tablets administered once daily for up to 144 weeks
5609|NCT02836236|O2|Outcome|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 144 weeks
5610|NCT02836236|O1|Outcome|TAF 25 mg|TAF 25 mg + TDF placebo tablets administered once daily for up to 144 weeks
5611|NCT02836236|O2|Outcome|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 144 weeks
5612|NCT02836236|O1|Outcome|TAF 25 mg|TAF 25 mg + TDF placebo tablets administered once daily for up to 144 weeks
5613|NCT02836236|E2|Reported Event|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 144 weeks
5614|NCT02836236|E1|Reported Event|TAF 25 mg|Tenofovir alafenamide (TAF) 25 mg + tenofovir disoproxil fumarate (TDF) placebo tablets administered once daily for up to 144 weeks
5615|NCT02834624|B3|Baseline|Total|Total of all reporting groups
5616|NCT02834624|B2|Baseline|Calfactant|Randomized to receive calfactant (Infasurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
5617|NCT02834624|B1|Baseline|Poractant|Randomized to receive poractant alfa (Curosurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
5618|NCT02834624|P2|Participant Flow|Calfactant|Randomized to receive calfactant (Infasurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
5619|NCT02834624|P1|Participant Flow|Poractant|Randomized to receive poractant alfa (Curosurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
5620|NCT02834624|O2|Outcome|Calfactant|Randomized to receive calfactant (Infasurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
5621|NCT02834624|O1|Outcome|Poractant|Randomized to receive Poractant alfa (Curosurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
5622|NCT02834624|O2|Outcome|Calfactant|Randomized to receive calfactant (Infasurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
5623|NCT02834624|O1|Outcome|Poractant|Randomized to receive poractant alfa (Curosurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
7587|NCT02759692|E1|Reported Event|Senofilcon A|Subjects that received the senofilcon A lens during any of the three study periods.
5625|NCT02834624|O1|Outcome|Poractant|Randomized to receive Poractant alfa (Curosurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
5626|NCT02834624|E2|Reported Event|Poractant Alfa|"Randomized to receive Curosurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.~Poractant alfa: Randomized to receive Curosurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist."
5627|NCT02834624|E1|Reported Event|Calfactant|"Randomized to receive Infasurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.~calfactant: Randomized to receive Infasurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist"
5628|NCT02832674|B1|Baseline|Single Treatment|"All enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment'~Percutaneous Radiofrequency single treatment: Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold."
5629|NCT02832674|P1|Participant Flow|Single Treatment|"All enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment'~Percutaneous Radiofrequency single treatment: Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold."
5630|NCT02832674|O1|Outcome|Single Treatment|"All enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment'~Percutaneous Radiofrequency single treatment: Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold."
5631|NCT02832674|O1|Outcome|Single Treatment|"All enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment'~Percutaneous Radiofrequency single treatment: Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold."
5632|NCT02832674|O1|Outcome|Single Treatment|"All enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment'~Percutaneous Radiofrequency single treatment: Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold."
5633|NCT02832674|O1|Outcome|Single Treatment|"All enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment'~Percutaneous Radiofrequency single treatment: Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold."
5634|NCT02832674|O1|Outcome|Single Treatment|"All enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment'~Percutaneous Radiofrequency single treatment: Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold."
5652|NCT02831660|O1|Outcome|Idarucizumab 5 g|The total dose of 5 g (two 2.5 g vials) was administered intravenously. A single vial contained 2.5 g of idarucizumab (in buffered solution for injection). Patients received a 2.5 g vial of study medication and a second 2.5 g vial within the next 15 minutes. In rare instances, an additional 5 g dose was to be justified.
5653|NCT02831660|E1|Reported Event|Idarucizumab 5 g|The total dose of 5 g (two 2.5 g vials) was administered intravenously. A single vial contained 2.5 g of idarucizumab (in buffered solution for injection). Patients received a 2.5 g vial of study medication and a second 2.5 g vial within the next 15 minutes. In rare instances, an additional 5 g dose was to be justified.
5635|NCT02832674|O1|Outcome|Single Treatment|"All enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment'~Percutaneous Radiofrequency single treatment: Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold."
5636|NCT02832674|E1|Reported Event|Single Treatment|"All enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment'~Percutaneous Radiofrequency single treatment: Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold."
5637|NCT02832375|B3|Baseline|Total|Total of all reporting groups
5638|NCT02832375|B2|Baseline|Control: Sodium Monofluorophosphate(SMFP)|Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
5639|NCT02832375|B1|Baseline|Experimental: Stannous Fluoride(SnF)|Participants were instructed to dose a dry toothbrush containing 0.454% w/w of SnF (1100ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
5640|NCT02832375|P2|Participant Flow|Control: Sodium Monofluorophosphate(SMFP)|Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
5641|NCT02832375|P1|Participant Flow|Experimental: Stannous Fluoride(SnF)|Participants were instructed to dose a dry toothbrush containing 0.454% weight by weight (w/w) of SnF (1100 parts per million [ppm] fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
5642|NCT02832375|O2|Outcome|Standard: Sodium Monofluorophosphate(SMFP)|Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
5643|NCT02832375|O1|Outcome|Experimental: Stannous Fluoride(SnF)|Participants were instructed to dose a dry toothbrush containing 0.454% w/w of SnF (1100ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
5644|NCT02832375|O2|Outcome|Standard: Sodium Monofluorophosphate(SMFP)|Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
5645|NCT02832375|O1|Outcome|Experimental: Stannous Fluoride(SnF)|Participants were instructed to dose a dry toothbrush containing 0.454% w/w of SnF (1100ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
5646|NCT02832375|O2|Outcome|Control: Sodium Monofluorophosphate(SMFP)|Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
5647|NCT02832375|O1|Outcome|Experimental: Stannous Fluoride(SnF)|Participants were instructed to dose a dry toothbrush containing 0.454% w/w of SnF (1100ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
5648|NCT02832375|E2|Reported Event|Standard: Sodium Monofluorophosphate(SMFP)|Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
5649|NCT02832375|E1|Reported Event|Experimental: Stannous Fluoride(SnF)|Participants were instructed to dose a dry toothbrush containing 0.454% w/w of SnF (1100ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
5650|NCT02831660|B1|Baseline|Idarucizumab 5 g|The total dose of 5 g (two 2.5 g vials) was administered intravenously. A single vial contained 2.5 g of idarucizumab (in buffered solution for injection). Patients received a 2.5 g vial of study medication and a second 2.5 g vial within the next 15 minutes. In rare instances, an additional 5 g dose was to be justified.
5651|NCT02831660|P1|Participant Flow|Idarucizumab 5 g|The total dose of 5 g (two 2.5 g vials) was administered intravenously. A single vial contained 2.5 g of idarucizumab (in buffered solution for injection). Patients received a 2.5 g vial of study medication and a second 2.5 g vial within the next 15 minutes. In rare instances, an additional 5 g dose was to be justified.
5654|NCT02829996|B6|Baseline|Total|Total of all reporting groups
5809|NCT02822287|E1|Reported Event|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
5655|NCT02829996|B5|Baseline|Latanoprost 0.0025% QD|"latanoprost 0.0025% ophthalmic solution~latanoprost 0.0025% QD: Latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
5656|NCT02829996|B4|Baseline|Latanoprost 0.005% QD|"latanoprost 0.005% ophthalmic solution~latanoprost 0.005% QD: Latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
5657|NCT02829996|B3|Baseline|Trabodenoson 6.0% / Latanoprost 0.0025% QD|"trabodenoson 6.0% / latanoprost 0.0025% Fixed-Dose Combination~trabodenoson 6.0% / latanoprost 0.0025% QD: Trabodenoson 6.0% / latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
5658|NCT02829996|B2|Baseline|Trabodenoson 3.0% / Latanoprost 0.005% QD|"trabodenoson 3.0% / latanoprost 0.005% Fixed-Dose Combination~trabodenoson 3.0% / latanoprost 0.005% QD: Trabodenoson 3.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
5659|NCT02829996|B1|Baseline|Trabodenoson 6.0% / Latanoprost 0.005% QD|"trabodenoson 6.0% / latanoprost 0.005% Fixed-Dose Combination~trabodenoson 6.0% / latanoprost 0.005% QD: Trabodenoson 6.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
5660|NCT02829996|P5|Participant Flow|Latanoprost 0.0025% QD|"latanoprost 0.0025% ophthalmic solution~latanoprost 0.0025% QD: Latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
5661|NCT02829996|P4|Participant Flow|Latanoprost 0.005% QD|"latanoprost 0.005% ophthalmic solution~latanoprost 0.005% QD: Latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
5662|NCT02829996|P3|Participant Flow|Trabodenoson 6.0% / Latanoprost 0.0025% QD|"trabodenoson 6.0% / latanoprost 0.0025% Fixed-Dose Combination~trabodenoson 6.0% / latanoprost 0.0025% QD: Trabodenoson 6.0% / latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
5663|NCT02829996|P2|Participant Flow|Trabodenoson 3.0% / Latanoprost 0.005% QD|"trabodenoson 3.0% / latanoprost 0.005% Fixed-Dose Combination~trabodenoson 3.0% / latanoprost 0.005% QD: Trabodenoson 3.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
5664|NCT02829996|P1|Participant Flow|Trabodenoson 6.0% / Latanoprost 0.005% QD|"trabodenoson 6.0% / latanoprost 0.005% Fixed-Dose Combination~trabodenoson 6.0% / latanoprost 0.005% QD: Trabodenoson 6.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
5665|NCT02829996|O5|Outcome|Latanoprost 0.0025% QD|"latanoprost 0.0025% ophthalmic solution~latanoprost 0.0025% QD: Latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
5666|NCT02829996|O4|Outcome|Latanoprost 0.005% QD|"latanoprost 0.005% ophthalmic solution~latanoprost 0.005% QD: Latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
5667|NCT02829996|O3|Outcome|Trabodenoson 6.0% / Latanoprost 0.0025% QD|"trabodenoson 6.0% / latanoprost 0.0025% Fixed-Dose Combination~trabodenoson 6.0% / latanoprost 0.0025% QD: Trabodenoson 6.0% / latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
5668|NCT02829996|O2|Outcome|Trabodenoson 3.0% / Latanoprost 0.005% QD|"trabodenoson 3.0% / latanoprost 0.005% Fixed-Dose Combination~trabodenoson 3.0% / latanoprost 0.005% QD: Trabodenoson 3.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
5669|NCT02829996|O1|Outcome|Trabodenoson 6.0% / Latanoprost 0.005% QD|"trabodenoson 6.0% / latanoprost 0.005% Fixed-Dose Combination~trabodenoson 6.0% / latanoprost 0.005% QD: Trabodenoson 6.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
5670|NCT02829996|E5|Reported Event|Latanoprost 0.0025% QD|"latanoprost 0.0025% ophthalmic solution~latanoprost 0.0025% QD: Latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
5671|NCT02829996|E4|Reported Event|Latanoprost 0.005% QD|"latanoprost 0.005% ophthalmic solution~latanoprost 0.005% QD: Latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
5672|NCT02829996|E3|Reported Event|Trabodenoson 6.0% / Latanoprost 0.0025% QD|"trabodenoson 6.0% / latanoprost 0.0025% Fixed-Dose Combination~trabodenoson 6.0% / latanoprost 0.0025% QD: Trabodenoson 6.0% / latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
5673|NCT02829996|E2|Reported Event|Trabodenoson 3.0% / Latanoprost 0.005% QD|"trabodenoson 3.0% / latanoprost 0.005% Fixed-Dose Combination~trabodenoson 3.0% / latanoprost 0.005% QD: Trabodenoson 3.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
5674|NCT02829996|E1|Reported Event|Trabodenoson 6.0% / Latanoprost 0.005% QD|"trabodenoson 6.0% / latanoprost 0.005% Fixed-Dose Combination~trabodenoson 6.0% / latanoprost 0.005% QD: Trabodenoson 6.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
5675|NCT02829983|B3|Baseline|Total|Total of all reporting groups
5676|NCT02829983|B2|Baseline|Placebo Group|"20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).~Placebo: Use of placebo tablets twice a day for 3 days.~One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device."
5677|NCT02829983|B1|Baseline|Clarithromycin Group|"20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg – 12/12 hours) for 3 days.~Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days~One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device."
5678|NCT02829983|P2|Participant Flow|Placebo Group|"20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).~Placebo: Use of placebo tablets twice a day for 3 days.~One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device."
5697|NCT02829463|O1|Outcome|Osteoarthritis Patients|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients with osteoarthritis. It's not the intervention the study applied, but the subjects' disease demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
5679|NCT02829983|P1|Participant Flow|Clarithromycin Group|"20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg – 12/12 hours) for 3 days.~Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days~One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device."
5680|NCT02829983|O2|Outcome|Placebo Group|"20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).~Placebo: Use of placebo tablets twice a day for 3 days.~One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device."
5681|NCT02829983|O1|Outcome|Clarithromycin Group|"20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg – 12/12 hours) for 3 days.~Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days~One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device."
5682|NCT02829983|O2|Outcome|Placebo Group|"20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).~Placebo: Use of placebo tablets twice a day for 3 days.~One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device."
5683|NCT02829983|O1|Outcome|Clarithromycin Group|"20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg – 12/12 hours) for 3 days.~Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days~One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device."
5684|NCT02829983|E2|Reported Event|Placebo Group|"20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).~Placebo: Use of placebo tablets twice a day for 3 days.~One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device."
5685|NCT02829983|E1|Reported Event|Clarithromycin Group|"20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg – 12/12 hours) for 3 days.~Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days~One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device."
5686|NCT02829775|B1|Baseline|Interferon Alfa-2A in Cancer Participants|Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study continued to receive the same treatment in this study. Pegylated interferon alfa-2A was administered subcutaneously once weekly and recombinant interferon alfa 2A was administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years).
5687|NCT02829775|P1|Participant Flow|Interferon Alfa-2A in Cancer Participants|Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study continued to receive the same treatment in this study. Pegylated interferon alfa-2A was administered subcutaneously once weekly and recombinant interferon alfa 2A was administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years).
5688|NCT02829775|O1|Outcome|Interferon Alfa-2A in Cancer Participants|Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study will continue to receive the same treatment in this study. Pegylated interferon alfa-2A will be administered subcutaneously once weekly and recombinant interferon alfa 2A will be administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years).
5689|NCT02829775|O1|Outcome|Interferon Alfa-2A in Cancer Participants|Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study continued to receive the same treatment in this study. Pegylated interferon alfa-2A was administered subcutaneously once weekly and recombinant interferon alfa 2A was administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years).
5690|NCT02829775|E1|Reported Event|Interferon Alfa-2A in Cancer Participants|Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study continued to receive the same treatment in this study. Pegylated interferon alfa-2A was administered subcutaneously once weekly and recombinant interferon alfa 2A was administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years).
5691|NCT02829463|B3|Baseline|Total|Total of all reporting groups
5692|NCT02829463|B2|Baseline|Healthy Controls|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients without osteoarthritis. It's not the intervention the study applied, but the subjects' non-osteoarthritis knee symptom demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
5693|NCT02829463|B1|Baseline|Osteoarthritis Patients|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients with osteoarthritis. It's not the intervention the study applied, but the subjects' disease demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
5694|NCT02829463|P2|Participant Flow|Healthy Controls|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients without osteoarthritis. It's not the intervention the study applied, but the subjects' non-osteoarthritis knee symptom demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
5695|NCT02829463|P1|Participant Flow|Osteoarthritis Patients|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients with osteoarthritis. It's not the intervention the study applied, but the subjects' disease demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
5696|NCT02829463|O2|Outcome|Healthy Controls|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients without osteoarthritis. It's not the intervention the study applied, but the subjects' non-osteoarthritis knee symptom demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
5802|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
5810|NCT02821403|B3|Baseline|Total|Total of all reporting groups
5698|NCT02829463|E2|Reported Event|Healthy Controls|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients without osteoarthritis. It's not the intervention the study applied, but the subjects' non-osteoarthritis knee symptom demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
5699|NCT02829463|E1|Reported Event|Osteoarthritis Patients|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients with osteoarthritis. It's not the intervention the study applied, but the subjects' disease demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
5700|NCT02829138|B3|Baseline|Total|Total of all reporting groups
5701|NCT02829138|B2|Baseline|Genetic Group|Genetic information and Omega-3 fat intake: Individuals in this group were provided with general nutrition information related to omega-3 fats and health, as well as information regarding the impact of a common variant in the FADS1 gene and how this variant influences omega-3 fatty acid profiles.
5702|NCT02829138|B1|Baseline|Non-genetic Group|General Nutrition related to Omega-3 fats: Individuals in this group were provided with only general nutrition information related to omega-3 fats and health.
5703|NCT02829138|P2|Participant Flow|Genetic Group|Genetic information and Omega-3 fat intake: Individuals in this group were provided with general nutrition information related to omega-3 fats and health, as well as information regarding the impact of a common variant in the FADS1 gene and how this variant influences omega-3 fatty acid profiles.
5704|NCT02829138|P1|Participant Flow|Non-genetic Group|General Nutrition related to Omega-3 fats: Individuals in this group were provided with only general nutrition information related to omega-3 fats and health.
5705|NCT02829138|O2|Outcome|Genetic Group|Genetic information and Omega-3 fat intake: Individuals in this group were provided with general nutrition information related to omega-3 fats and health, as well as information regarding the impact of a common variant in the FADS1 gene and how this variant influences omega-3 fatty acid profiles.
5706|NCT02829138|O1|Outcome|Non-genetic Group|General Nutrition related to Omega-3 fats: Individuals in this group were provided with only general nutrition information related to omega-3 fats and health.
5707|NCT02829138|O2|Outcome|Genetic Group|Genetic information and Omega-3 fat intake: Individuals in this group were provided with general nutrition information related to omega-3 fats and health, as well as information regarding the impact of a common variant in the FADS1 gene and how this variant influences omega-3 fatty acid profiles.
5708|NCT02829138|O1|Outcome|Non-genetic Group|General Nutrition related to Omega-3 fats: Individuals in this group were provided with only general nutrition information related to omega-3 fats and health.
5709|NCT02829138|O2|Outcome|Genetic Group|Genetic information and Omega-3 fat intake: Individuals in this group were provided with general nutrition information related to omega-3 fats and health, as well as information regarding the impact of a common variant in the FADS1 gene and how this variant influences omega-3 fatty acid profiles.
5710|NCT02829138|O1|Outcome|Non-genetic Group|General Nutrition related to Omega-3 fats: Individuals in this group were provided with only general nutrition information related to omega-3 fats and health.
5711|NCT02829138|E2|Reported Event|Genetic Group|Genetic information and Omega-3 fat intake: Individuals in this group were provided with general nutrition information related to omega-3 fats and health, as well as information regarding the impact of a common variant in the FADS1 gene and how this variant influences omega-3 fatty acid profiles.
5712|NCT02829138|E1|Reported Event|Non-genetic Group|General Nutrition related to Omega-3 fats: Individuals in this group were provided with only general nutrition information related to omega-3 fats and health.
5713|NCT02828137|B4|Baseline|Total|Total of all reporting groups
5714|NCT02828137|B3|Baseline|High NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio > 3.90
5715|NCT02828137|B2|Baseline|Intermediate NLR Group|1.78 < Neutrophil-to-Lymphocyte (NLR) Ratio < 3.90
5716|NCT02828137|B1|Baseline|Low NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio < 1.78
5717|NCT02828137|P3|Participant Flow|High NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio > 3.90
5718|NCT02828137|P2|Participant Flow|Intermediate NLR Group|1.78 < Neutrophil-to-Lymphocyte (NLR) Ratio < 3.90
5719|NCT02828137|P1|Participant Flow|Low NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio < 1.78
5720|NCT02828137|O3|Outcome|High NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio > 3.90 IMR 32.95 ± 20.60
5721|NCT02828137|O2|Outcome|Intermediate NLR Group|1.78 < Neutrophil-to-Lymphocyte (NLR) Ratio < 3.90 IMR 23.22 ± 12.73
5722|NCT02828137|O1|Outcome|Low NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio < 1.78 IMR 21.94 ± 12.87
5723|NCT02828137|E3|Reported Event|High NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio > 3.90
5724|NCT02828137|E2|Reported Event|Intermediate NLR Group|1.78 < Neutrophil-to-Lymphocyte (NLR) Ratio < 3.90
5725|NCT02828137|E1|Reported Event|Low NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio < 1.78
5726|NCT02826551|B3|Baseline|Total|Total of all reporting groups
5727|NCT02826551|B2|Baseline|Injection|"These patients will receive standard of care when undergoing anterior cruciate ligament reconstruction but will additionally be receiving a one-time posterior capsular knee injection of Marcaine 0.5% (20cc) during the surgery.~They will be monitored for pain control and pill intake while in the PACU and the first four days post-operatively the same as the patients in the NO injection Arm of the study.~Marcaine: Pain control medication to theoretically reduce the amount of posterior knee pain that is common after ACL surgery by placing the injection into the posterior capsule of the knee during surgery. This is very easy and safe to accomplish as the surgeon will have direct visualization of the posterior capsule during the surgery.~Ice~Percocet~Knee Brace and Crutches"
5728|NCT02826551|B1|Baseline|No Injection|"These patients will receive standard of care when undergoing anterior cruciate ligament reconstruction and will NOT be receiving a posterior capsular knee injection of Marcaine 0.5%.~They will be monitored for pain control and pill intake while in the PACU and the first four days post-operatively the same as the patients in the INJECTION Arm of the study.~Ice~Percocet~Knee Brace and Crutches"
5803|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
5804|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
5729|NCT02826551|P2|Participant Flow|Injection|"These patients will receive standard of care when undergoing anterior cruciate ligament reconstruction but will additionally be receiving a one-time posterior capsular knee injection of Marcaine 0.5% (20cc) during the surgery.~They will be monitored for pain control and pill intake while in the PACU and the first four days post-operatively the same as the patients in the NO injection Arm of the study.~Marcaine: Pain control medication to theoretically reduce the amount of posterior knee pain that is common after ACL surgery by placing the injection into the posterior capsule of the knee during surgery. This is very easy and safe to accomplish as the surgeon will have direct visualization of the posterior capsule during the surgery.~Ice~Percocet~Knee Brace and Crutches"
5730|NCT02826551|P1|Participant Flow|No Injection|"These patients will receive standard of care when undergoing anterior cruciate ligament reconstruction and will NOT be receiving a posterior capsular knee injection of Marcaine 0.5%.~They will be monitored for pain control and pill intake while in the PACU and the first four days post-operatively the same as the patients in the INJECTION Arm of the study.~Ice~Percocet~Knee Brace and Crutches"
5731|NCT02826551|O2|Outcome|Injection|"These patients will receive standard of care when undergoing anterior cruciate ligament reconstruction but will additionally be receiving a one-time posterior capsular knee injection of Marcaine 0.5% (20cc) during the surgery.~They will be monitored for pain control and pill intake while in the PACU and the first four days post-operatively the same as the patients in the NO injection Arm of the study.~Marcaine: Pain control medication to theoretically reduce the amount of posterior knee pain that is common after ACL surgery by placing the injection into the posterior capsule of the knee during surgery. This is very easy and safe to accomplish as the surgeon will have direct visualization of the posterior capsule during the surgery.~Ice~Percocet~Knee Brace and Crutches"
5732|NCT02826551|O1|Outcome|No Injection|"These patients will receive standard of care when undergoing anterior cruciate ligament reconstruction and will NOT be receiving a posterior capsular knee injection of Marcaine 0.5%.~They will be monitored for pain control and pill intake while in the PACU and the first four days post-operatively the same as the patients in the INJECTION Arm of the study.~Ice~Percocet~Knee Brace and Crutches"
5733|NCT02826551|E2|Reported Event|Injection|"These patients will receive standard of care when undergoing anterior cruciate ligament reconstruction but will additionally be receiving a one-time posterior capsular knee injection of Marcaine 0.5% (20cc) during the surgery.~They will be monitored for pain control and pill intake while in the PACU and the first four days post-operatively the same as the patients in the NO injection Arm of the study.~Marcaine: Pain control medication to theoretically reduce the amount of posterior knee pain that is common after ACL surgery by placing the injection into the posterior capsule of the knee during surgery. This is very easy and safe to accomplish as the surgeon will have direct visualization of the posterior capsule during the surgery.~Ice~Percocet~Knee Brace and Crutches"
5734|NCT02826551|E1|Reported Event|No Injection|"These patients will receive standard of care when undergoing anterior cruciate ligament reconstruction and will NOT be receiving a posterior capsular knee injection of Marcaine 0.5%.~They will be monitored for pain control and pill intake while in the PACU and the first four days post-operatively the same as the patients in the INJECTION Arm of the study.~Ice~Percocet~Knee Brace and Crutches"
5735|NCT02826421|B5|Baseline|Total|Total of all reporting groups
5736|NCT02826421|B4|Baseline|Monarch III D|Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery
5737|NCT02826421|B3|Baseline|iSert|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
5738|NCT02826421|B2|Baseline|iTec|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
5739|NCT02826421|B1|Baseline|UltraSert|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
5740|NCT02826421|P4|Participant Flow|Monarch III D|Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery
5741|NCT02826421|P3|Participant Flow|iSert|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
5742|NCT02826421|P2|Participant Flow|iTec|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
5743|NCT02826421|P1|Participant Flow|UltraSert|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
5744|NCT02826421|O2|Outcome|Monarch III D|Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery
5745|NCT02826421|O1|Outcome|UltraSert|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
5746|NCT02826421|O3|Outcome|iSert|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
5747|NCT02826421|O2|Outcome|iTec|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
5748|NCT02826421|O1|Outcome|UltraSert|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
5749|NCT02826421|E5|Reported Event|Monarch III D|All subjects treated with Monarch III D
5750|NCT02826421|E4|Reported Event|iSert|All subjects treated with iSert
5751|NCT02826421|E3|Reported Event|iTec|All subjects treated with iTec
5752|NCT02826421|E2|Reported Event|UltraSert|All subjects treated with UltraSert
5753|NCT02826421|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to initiation of study treatment
5754|NCT02824913|B3|Baseline|Total|Total of all reporting groups
5755|NCT02824913|B2|Baseline|Placebo Comparator Then P-321 Ophthalmic Solution|"At Visit 2 Placebo comparator will be administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II~At Visit 3 0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II P-321 Ophthalmic Solution"
5756|NCT02824913|B1|Baseline|P-321 Ophthalmic Solution Then Placebo Comparator|"At Visit 2 0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II P-321 Ophthalmic Solution~At Visit 3 Placebo comparator will be administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II"
5805|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
5757|NCT02824913|P2|Participant Flow|Placebo Comparator Then P-321 Ophthalmic Solution|"At Visit 2 Placebo treatment will be administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II~After a washout period of 7-14 days at Visit 3 0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II"
5758|NCT02824913|P1|Participant Flow|P-321 Ophthalmic Solution Then Placebo Comparator|"At Visit 2 0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II~After a washout period of 7-14 days at Visit 3 Placebo Comparator will be administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II"
5759|NCT02824913|O2|Outcome|Drug: P-321 Ophthalmic Solution Placebo|"Placebo treatment administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II~P-321 Ophthalmic Solution placebo"
5760|NCT02824913|O1|Outcome|P-321 Ophthalmic Solution|"0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II~P-321 Ophthalmic Solution"
5761|NCT02824913|O2|Outcome|Placebo Comparator Then P-321 Ophthalmic Solution|"At Visit 2 Placebo treatment will r administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II~After a washout period of 7-14 days at Visit 3 0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II"
5762|NCT02824913|O1|Outcome|P-321 Ophthalmic Solution Then Placebo Comparator|"At Visit 2 0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II~After a washout period of 7-14 days at Visit 3 Placebo Comparator will be administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II"
5763|NCT02824913|O2|Outcome|Placebo Comparator|Visit 3 - Ophthalmic Solution placebo will be administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II
5764|NCT02824913|O1|Outcome|P-321 Ophthalmic Solution|Visit 2 - 0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II
5765|NCT02824913|E2|Reported Event|Drug: P-321 Ophthalmic Solution Placebo|"Placebo treatment administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II~P-321 Ophthalmic Solution placebo"
5766|NCT02824913|E1|Reported Event|P-321 Ophthalmic Solution|"0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II~P-321 Ophthalmic Solution"
5767|NCT02823964|B1|Baseline|Liprotamase|"Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement~Liprotamase: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement"
5768|NCT02823964|P1|Participant Flow|Liprotamase|"Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement~Liprotamase: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement"
5769|NCT02823964|O1|Outcome|Liprotamase|"Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement~Liprotamase: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement"
5770|NCT02823964|E1|Reported Event|Liprotamase|"Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement~Liprotamase: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement"
5771|NCT02823080|B3|Baseline|Total|Total of all reporting groups
5772|NCT02823080|B2|Baseline|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
5773|NCT02823080|B1|Baseline|Cetrotide|study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
5774|NCT02823080|P2|Participant Flow|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
5775|NCT02823080|P1|Participant Flow|Cetrotide|study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD(maximal ovarian diameter) were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
5776|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
5777|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-days Cetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
5778|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
20032|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
5779|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-days Cetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
5780|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
5781|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-days Cetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
5782|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
5783|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-days Cetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
5784|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
5785|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-days Cetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
5786|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
5787|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
5788|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
5789|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
5790|NCT02823080|E2|Reported Event|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
5791|NCT02823080|E1|Reported Event|Cetrotide|study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
5792|NCT02822885|B1|Baseline|Ultrasonography|"Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries~Ultrasonography: Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries"
5793|NCT02822885|P1|Participant Flow|Ultrasonography|Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
5794|NCT02822885|O1|Outcome|Ultrasonography|Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
5795|NCT02822885|O1|Outcome|Ultrasonography|Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
5796|NCT02822885|O1|Outcome|Ultrasonography|Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
5797|NCT02822885|O1|Outcome|Ultrasonography|Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
5798|NCT02822885|O1|Outcome|Ultrasonography|Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
5799|NCT02822885|E1|Reported Event|Ultrasonography|Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
5800|NCT02822287|B1|Baseline|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
5801|NCT02822287|P1|Participant Flow|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
5811|NCT02821403|B2|Baseline|Middle-aged Adults|"adults with presbyopia who aged over 40 years~Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating"
5812|NCT02821403|B1|Baseline|Young Adults|"adults without presbyopia who aged 18-35 years~Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating"
5813|NCT02821403|P2|Participant Flow|Middle-aged Adults|"adults with presbyopia who aged over 40 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~Cross-over study design: The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
5814|NCT02821403|P1|Participant Flow|Young Adults|"adults without presbyopia who aged 18-35 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~Cross-over study design: The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
5815|NCT02821403|O2|Outcome|Middle-aged Adults|"adults with presbyopia who aged over 40 years~Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating"
5816|NCT02821403|O1|Outcome|Young Adults|"adults without presbyopia who aged 18-35 years~Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating"
5817|NCT02821403|O6|Outcome|Middle-aged Adults: Clear Lens With Blue-light Blocking Coatin|"adults with presbyopia who aged over 40 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
5818|NCT02821403|O5|Outcome|Middle-aged Adults: Regular Coating Lens With Yellow Tint|"adults with presbyopia who aged over 40 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
5819|NCT02821403|O4|Outcome|Middle-aged Adults: Clear Lens With Regular Coating|"adults with presbyopia who aged over 40 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
5820|NCT02821403|O3|Outcome|Young Adults: Clear Lens With Blue-light Blocking Coating|"adults without presbyopia who aged 18-35 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
5821|NCT02821403|O2|Outcome|Young Adults: Regular Coating Lens With Yellow Tint|"adults without presbyopia who aged 18-35 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
5822|NCT02821403|O1|Outcome|Young Adults: Clear Lens With Regular Coating|"adults without presbyopia who aged 18-35 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
5823|NCT02821403|O6|Outcome|Middle-aged Adults: Clear Lens With Blue-light Blocking Coatin|"adults with presbyopia who aged over 40 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
5824|NCT02821403|O5|Outcome|Middle-aged Adults: Regular Coating Lens With Yellow Tint|"adults with presbyopia who aged over 40 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
5825|NCT02821403|O4|Outcome|Middle-aged Adults: Clear Lens With Regular Coating|"adults with presbyopia who aged over 40 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
5826|NCT02821403|O3|Outcome|Young Adults: Clear Lens With Blue-light Blocking Coating|"adults without presbyopia who aged 18-35 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
5827|NCT02821403|O2|Outcome|Young Adults: Regular Coating Lens With Yellow Tint|"adults without presbyopia who aged 18-35 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
5828|NCT02821403|O1|Outcome|Young Adults: Clear Lens With Regular Coating|"adults without presbyopia who aged 18-35 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
5829|NCT02821403|E2|Reported Event|Middle-aged Adults|"adults with presbyopia who aged over 40 years~Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating"
5830|NCT02821403|E1|Reported Event|Young Adults|"adults without presbyopia who aged 18-35 years~Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating"
5831|NCT02818244|B5|Baseline|Total|Total of all reporting groups
5832|NCT02818244|B4|Baseline|Apple Watch|Apple Watch Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
5833|NCT02818244|B3|Baseline|Tom Tom Spark Cardio|Tom Tom Spark Cardio Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
5834|NCT02818244|B2|Baseline|Garmin Forerunner 235|Garmin Forerunner 235 Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
5835|NCT02818244|B1|Baseline|Fit Bit Blaze|Fit Bit Blaze Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
5836|NCT02818244|P4|Participant Flow|Apple Watch|Apple Watch Heart Rate Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
5837|NCT02818244|P3|Participant Flow|Tom Tom Spark Cardio|Tom Tom Spark Cardio Heart Rate Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
5838|NCT02818244|P2|Participant Flow|Garmin Forerunner 235|Garmin Forerunner 235 Heart Rate Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
5839|NCT02818244|P1|Participant Flow|Fit Bit Blaze|Fit Bit Blaze Heart Rate Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
5840|NCT02818244|O4|Outcome|Apple Watch|Apple Watch Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
5841|NCT02818244|O3|Outcome|Tom Tom Spark Cardio|Tom Tom Spark Cardio Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
5842|NCT02818244|O2|Outcome|Garmin Forerunner 235|Garmin Forerunner 235 Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
5843|NCT02818244|O1|Outcome|Fit Bit Blaze|Fit Bit Blaze Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
5844|NCT02818244|E4|Reported Event|Apple Watch|Apple Watch Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
5845|NCT02818244|E3|Reported Event|Tom Tom Spark Cardio|Tom Tom Spark Cardio Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
5846|NCT02818244|E2|Reported Event|Garmin Forerunner 235|Garmin Forerunner 235 Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
5847|NCT02818244|E1|Reported Event|Fit Bit Blaze|Fit Bit Blaze Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
5848|NCT02817763|B3|Baseline|Total|Total of all reporting groups
5849|NCT02817763|B2|Baseline|CTG Plus Resin Composite Restoration|"After local anesthesia, a sterile rubber dam was placed to isolate the operative field and the coronal zone of the non-carious cervical lesion restoration was performed with a nanocomposite resin, following the manufacturer's instructions. The apical margin of the restoration was place 1 millimeter beyond to the cemento-enamel junction estimation. In the next session, the surgical procedure performed was the trapezoidal-type of CAF. After the trapezoidal-type of CAF flap was raised, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~CTG plus resin composite restoration: Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
5850|NCT02817763|B1|Baseline|Connective Tissue Graft (CTG)|"After local anesthesia, the surgical procedure performed was the trapezoidal-type of Coronally advanced flap (CAF). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~Connective tissue graft (CTG): Periodontal surgical technique to treat gingival recessions~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
5851|NCT02817763|P2|Participant Flow|CTG Plus Resin Composite Restoration|"After local anesthesia, a sterile rubber dam was placed to isolate the operative field and the coronal zone of the non-carious cervical lesion restoration was performed with a nanocomposite resin, following the manufacturer's instructions. The apical margin of the restoration was place 1 millimeter beyond to the cemento-enamel junction estimation. In the next session, the surgical procedure performed was the trapezoidal-type of CAF. After the trapezoidal-type of CAF flap was raised, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~CTG plus resin composite restoration: Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
5870|NCT02815735|O3|Outcome|Lotrafilcon B (2 Weeks)|"Participants wear lotrafilcon B lens for 4 weeks during the cross over study.~lotrafilcon B: contact lens"
5852|NCT02817763|P1|Participant Flow|Connective Tissue Graft (CTG)|"After local anesthesia, the surgical procedure performed was the trapezoidal-type of Coronally advanced flap (CAF). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~Connective tissue graft (CTG): Periodontal surgical technique to treat gingival recessions~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
5853|NCT02817763|O2|Outcome|CTG Plus Resin Composite Restoration|"After local anesthesia, a sterile rubber dam was placed to isolate the operative field and the coronal zone of the non-carious cervical lesion restoration was performed with a nanocomposite resin, following the manufacturer's instructions. The apical margin of the restoration was place 1 millimeter beyond to the cemento-enamel junction estimation. In the next session, the surgical procedure performed was the trapezoidal-type of CAF. After the trapezoidal-type of CAF flap was raised, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~CTG plus resin composite restoration: Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
5854|NCT02817763|O1|Outcome|Connective Tissue Graft (CTG)|"After local anesthesia, the surgical procedure performed was the trapezoidal-type of Coronally advanced flap (CAF). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~Connective tissue graft (CTG): Periodontal surgical technique to treat gingival recessions~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
5855|NCT02817763|O2|Outcome|CTG Plus Resin Composite Restoration|"After local anesthesia, a sterile rubber dam was placed to isolate the operative field and the coronal zone of the non-carious cervical lesion restoration was performed with a nanocomposite resin, following the manufacturer's instructions. The apical margin of the restoration was place 1 millimeter beyond to the cemento-enamel junction estimation. In the next session, the surgical procedure performed was the trapezoidal-type of CAF. After the trapezoidal-type of CAF flap was raised, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~CTG plus resin composite restoration: Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
5856|NCT02817763|O1|Outcome|Connective Tissue Graft (CTG)|"After local anesthesia, the surgical procedure performed was the trapezoidal-type of Coronally advanced flap (CAF). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~Connective tissue graft (CTG): Periodontal surgical technique to treat gingival recessions~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
5857|NCT02817763|E2|Reported Event|CTG Plus Resin Composite Restoration|"After local anesthesia, a sterile rubber dam was placed to isolate the operative field and the coronal zone of the non-carious cervical lesion restoration was performed with a nanocomposite resin, following the manufacturer's instructions. The apical margin of the restoration was place 1 millimeter beyond to the cemento-enamel junction estimation. In the next session, the surgical procedure performed was the trapezoidal-type of CAF. After the trapezoidal-type of CAF flap was raised, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~CTG plus resin composite restoration: Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
5858|NCT02817763|E1|Reported Event|Connective Tissue Graft (CTG)|"After local anesthesia, the surgical procedure performed was the trapezoidal-type of Coronally advanced flap (CAF). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~Connective tissue graft (CTG): Periodontal surgical technique to treat gingival recessions~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
5859|NCT02815735|B1|Baseline|Overall Participants|"Participants wear comfilcon A and lotrafilcon B lens for 4 weeks during the cross over study.~comfilcon A: contact lens~lotrafilcon B: contact lens"
5860|NCT02815735|P2|Participant Flow|Lotrafilcon B, Then Comfilcon A|"Participants wear lotrafilcon B lens, then comfilcon A lens for 4 weeks during the cross over study.~lotrafilcon B: contact lens~comfilcon A: contact lens"
5861|NCT02815735|P1|Participant Flow|Comfilcon A, Then Lotrafilcon B|"Participants wear comfilcon A lens, then lotrafilcon B for 4 weeks during the cross over study.~comfilcon A: contact lens~lotrafilcon B: contact lens"
5862|NCT02815735|O6|Outcome|Lotrafilcon B (Day 26)|"Participants wear lotrafilcon B lens for 4 weeks during the cross over study.~lotrafilcon B: contact lens"
5863|NCT02815735|O5|Outcome|Comfilcon A (Day 26)|"Participants wear comfilcon A lens for 4 weeks during the cross over study.~comfilcon A: contact lens"
5864|NCT02815735|O4|Outcome|Lotrafilcon B (Day 12)|"Participants wear lotrafilcon B lens for 4 weeks during the cross over study.~lotrafilcon B: contact lens"
5865|NCT02815735|O3|Outcome|Comfilcon A (Day 12)|"Participants wear comfilcon A lens for 4 weeks during the cross over study.~comfilcon A: contact lens"
5866|NCT02815735|O2|Outcome|Lotrafilcon B (Day 3)|"Participants wear lotrafilcon B lens for 4 weeks during the cross over study.~lotrafilcon B: contact lens"
5867|NCT02815735|O1|Outcome|Comfilcon A (Day 3)|"Participants wear comfilcon A lens for 4 weeks during the cross over study.~comfilcon A: contact lens"
5868|NCT02815735|O5|Outcome|Lotrafilcon B (4 Weeks)|"Participants wear lotrafilcon B lens for 4 weeks during the cross over study.~lotrafilcon B: contact lens"
5869|NCT02815735|O4|Outcome|Comfilcon A (4 Weeks)|"Participants wear comfilcon A lens for 4 weeks during the cross over study.~comfilcon A: contact lens"
5871|NCT02815735|O2|Outcome|Comfilcon A (2 Weeks)|"Participants wear comfilcon A lens for 4 weeks during the cross over study.~comfilcon A: contact lens"
5872|NCT02815735|O1|Outcome|Habitual (Baseline)|Habitual data assessed at baseline.
5873|NCT02815735|E2|Reported Event|Lotrafilcon B|"Participants wear lotrafilcon B lens for 4 weeks during the cross over study.~lotrafilcon B: contact lens"
5874|NCT02815735|E1|Reported Event|Comfilcon A|"Participants wear comfilcon A lens for 4 weeks during the cross over study.~comfilcon A: contact lens"
5875|NCT02815397|B1|Baseline|Single Arm, Open Label|"Metformin added to standard of care treatment for all patients~Metformin: given in addition to standard of care treatment"
5876|NCT02815397|P1|Participant Flow|Single Arm, Open Label|"Metformin added to standard of care treatment for all patients~Metformin: given in addition to standard of care treatment"
5877|NCT02815397|O1|Outcome|Single Arm, Open Label|"Metformin added to standard of care treatment for all patients~Metformin: given in addition to standard of care treatment"
5878|NCT02815397|O1|Outcome|Single Arm, Open Label|"Metformin added to standard of care treatment for all patients~Metformin: given in addition to standard of care treatment"
5879|NCT02815397|O1|Outcome|Single Arm, Open Label|"Metformin added to standard of care treatment for all patients~Metformin: given in addition to standard of care treatment"
5880|NCT02815397|O1|Outcome|Single Arm, Open Label|"Metformin added to standard of care treatment for all patients~Metformin: given in addition to standard of care treatment"
5881|NCT02815397|E1|Reported Event|Single Arm, Open Label|"Metformin added to standard of care treatment for all patients~Metformin: given in addition to standard of care treatment"
5882|NCT02814643|B3|Baseline|Total|Total of all reporting groups
5883|NCT02814643|B2|Baseline|Placebo|Placebo to benralizumab subcutaneous
5884|NCT02814643|B1|Baseline|Benralizumab 30mg|Benralizumab 30mg/day subcutaneous
5885|NCT02814643|P2|Participant Flow|Placebo|Placebo to benralizumab subcutaneous
5886|NCT02814643|P1|Participant Flow|Benralizumab 30mg|Benralizumab 30mg/day subcutaneous
5887|NCT02814643|O2|Outcome|Placebo|Placebo to benralizumab subcutaneous
5888|NCT02814643|O1|Outcome|Benralizumab 30mg|Benralizumab 30mg/day subcutaneous
5889|NCT02814643|O2|Outcome|Placebo|Placebo to benralizumab subcutaneous
5890|NCT02814643|O1|Outcome|Benralizumab 30mg|Benralizumab 30mg/day subcutaneous
5891|NCT02814643|O2|Outcome|Placebo|Placebo to benralizumab subcutaneous
5892|NCT02814643|O1|Outcome|Benralizumab 30mg|Benralizumab 30mg/day subcutaneous
5893|NCT02814643|O2|Outcome|Placebo|Placebo to benralizumab subcutaneous
5894|NCT02814643|O1|Outcome|Benralizumab 30mg|Benralizumab 30mg/day subcutaneous
5895|NCT02814643|O2|Outcome|Placebo|Placebo to benralizumab subcutaneous
5896|NCT02814643|O1|Outcome|Benralizumab 30mg|Benralizumab 30mg/day subcutaneous
5897|NCT02814643|O2|Outcome|Placebo|Placebo to benralizumab subcutaneous
5898|NCT02814643|O1|Outcome|Benralizumab 30mg|Benralizumab 30mg/day subcutaneous
5899|NCT02814643|O2|Outcome|Placebo|Placebo to benralizumab subcutaneous
5900|NCT02814643|O1|Outcome|Benralizumab 30mg|Benralizumab 30mg/day subcutaneous
5901|NCT02814643|O2|Outcome|Placebo|Placebo to benralizumab subcutaneous
5902|NCT02814643|O1|Outcome|Benralizumab 30mg|Benralizumab 30mg/day subcutaneous
5903|NCT02814643|O2|Outcome|Placebo|Placebo to benralizumab subcutaneous
5904|NCT02814643|O1|Outcome|Benralizumab 30mg|Benralizumab 30mg/day subcutaneous
5905|NCT02814643|E2|Reported Event|Placebo|Placebo to benralizumab subcutaneous
5906|NCT02814643|E1|Reported Event|Benralizumab 30mg|Benralizumab 30mg/day subcutaneous
5907|NCT02814279|B3|Baseline|Total|Total of all reporting groups
5908|NCT02814279|B2|Baseline|Tunnel Plus Connective Tissue Graft|"The tunnel flap was performed according to Zuhr et al., 2007. Following initial sulcular incisions, spit thickness flap was prepared using specific tunneling knives beyond the mucogingival junction and until flap gain mobility. The flap was laterally extended to adjacent papillae that were carefully detached by means of a full-thickness preparation. The connective tissue graft was insert into the tunnel. Sling sutures were performed involving the flap and graft to coronally cover 2 mm above the CEJ.~Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
5909|NCT02814279|B1|Baseline|CAF Plus Connective Tissue Graft|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was removed from the palate according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions.~CAF plus connective tissue graft: Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
5910|NCT02814279|P2|Participant Flow|Tunnel Plus Connective Tissue Graft|"The tunnel flap was performed according to Zuhr et al., 2007. Following initial sulcular incisions, spit thickness flap was prepared using specific tunneling knives beyond the mucogingival junction and until flap gain mobility. The flap was laterally extended to adjacent papillae that were carefully detached by means of a full-thickness preparation. The connective tissue graft was insert into the tunnel. Sling sutures were performed involving the flap and graft to coronally cover 2 mm above the CEJ.~Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
5921|NCT02814227|O1|Outcome|Zansors® Sleep Screening Device|"Zansors device compared to overnight polysomnography~Zansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography"
5911|NCT02814279|P1|Participant Flow|CAF Plus Connective Tissue Graft|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was removed from the palate according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions.~CAF plus connective tissue graft: Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
5912|NCT02814279|O2|Outcome|Tunnel Plus Connective Tissue Graft|"The tunnel flap was performed according to Zuhr et al., 2007. Following initial sulcular incisions, spit thickness flap was prepared using specific tunneling knives beyond the mucogingival junction and until flap gain mobility. The flap was laterally extended to adjacent papillae that were carefully detached by means of a full-thickness preparation. The connective tissue graft was insert into the tunnel. Sling sutures were performed involving the flap and graft to coronally cover 2 mm above the CEJ.~Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
5913|NCT02814279|O1|Outcome|CAF Plus Connective Tissue Graft|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was removed from the palate according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions.~CAF plus connective tissue graft: Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
5914|NCT02814279|O2|Outcome|Tunnel Plus Connective Tissue Graft|"The tunnel flap was performed according to Zuhr et al., 2007. Following initial sulcular incisions, spit thickness flap was prepared using specific tunneling knives beyond the mucogingival junction and until flap gain mobility. The flap was laterally extended to adjacent papillae that were carefully detached by means of a full-thickness preparation. The connective tissue graft was insert into the tunnel. Sling sutures were performed involving the flap and graft to coronally cover 2 mm above the CEJ.~Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
5915|NCT02814279|O1|Outcome|CAF Plus Connective Tissue Graft|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was removed from the palate according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions.~CAF plus connective tissue graft: Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
5916|NCT02814279|E2|Reported Event|Tunnel Plus Connective Tissue Graft|"The tunnel flap was performed according to Zuhr et al., 2007. Following initial sulcular incisions, spit thickness flap was prepared using specific tunneling knives beyond the mucogingival junction and until flap gain mobility. The flap was laterally extended to adjacent papillae that were carefully detached by means of a full-thickness preparation. The connective tissue graft was insert into the tunnel. Sling sutures were performed involving the flap and graft to coronally cover 2 mm above the CEJ.~Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
5917|NCT02814279|E1|Reported Event|CAF Plus Connective Tissue Graft|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was removed from the palate according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions.~CAF plus connective tissue graft: Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
5918|NCT02814227|B1|Baseline|Zansors® Sleep Screening Device|"Zansors device compared to overnight polysomnography~Zansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography"
5919|NCT02814227|P1|Participant Flow|Zansors® Sleep Screening Device|"Zansors device compared to overnight polysomnography~Zansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography"
5920|NCT02814227|O1|Outcome|Zansors® Sleep Screening Device|"Zansors device compared to overnight polysomnography~Zansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography"
5957|NCT02811965|E5|Reported Event|Offloading Device A|Pressure mapping is performed with Offloading Device A applied to the heel.
9666|NCT02709577|P3|Participant Flow|Cohort A Control Sham|Device was not implanted
5922|NCT02814227|O1|Outcome|Zansors® Sleep Screening Device|"Zansors device compared to overnight polysomnography~Zansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography"
5923|NCT02814227|O1|Outcome|Zansors® Sleep Screening Device|"Zansors device compared to overnight polysomnography~Zansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography"
5924|NCT02814227|E1|Reported Event|Zansors® Sleep Screening Device|"Zansors device compared to overnight polysomnography~Zansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography"
5925|NCT02813070|B4|Baseline|Total|Total of all reporting groups
5926|NCT02813070|B3|Baseline|Healthy Volunteers|Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
5927|NCT02813070|B2|Baseline|Participants With Amnestic Mild Cognitive Impairment|Participants with baseline diagnosis of aMCI, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
5928|NCT02813070|B1|Baseline|Participants With Probable Alzheimer's Disease|Participants with baseline diagnosis of pAD, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
5929|NCT02813070|P3|Participant Flow|Healthy Volunteers|Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
5930|NCT02813070|P2|Participant Flow|Participants With Amnestic Mild Cognitive Impairment|Participants with baseline diagnosis of amnestic mild cognitive impairment (aMCI), received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
5931|NCT02813070|P1|Participant Flow|Participants With Probable Alzheimer's Disease|Participants with baseline diagnosis of probable Alzheimer's disease (pAD), received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent Positron emission tomography (PET) imaging.
5932|NCT02813070|O2|Outcome|Healthy Volunteers|Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
5933|NCT02813070|O1|Outcome|Participants With Probable Alzheimer's Disease|Participants with baseline diagnosis of pAD, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
5934|NCT02813070|O2|Outcome|Healthy Volunteers|Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
5935|NCT02813070|O1|Outcome|Participants With Probable Alzheimer's Disease|Participants with baseline diagnosis of pAD, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
5936|NCT02813070|E3|Reported Event|Healthy Volunteers|Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
5937|NCT02813070|E2|Reported Event|Participants With Amnestic Mild Cognitive Impairment|Participants with baseline diagnosis of aMCI, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
5938|NCT02813070|E1|Reported Event|Participants With Probable Alzheimer's Disease|Participants with baseline diagnosis of pAD, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
5939|NCT02811965|B1|Baseline|Healthy Research Subjects|Each research subject will have pressure mapping performed on his or her right foot in the 7 interventions listed to determine the contact forces experienced by the heel in each off-loading condition. Each intervention will be randomly applied.
5940|NCT02811965|P1|Participant Flow|Healthy Research Subjects|Each research subject will have pressure mapping performed on his or her right foot in the 7 interventions listed to determine the contact forces experienced by the heel in each off-loading condition. Each intervention will be randomly applied.
5941|NCT02811965|O7|Outcome|Offloading Device C|Pressure mapping is performed with Offloading Device C applied to the heel.
5942|NCT02811965|O6|Outcome|Offloading Device B|Pressure mapping is performed with Offloading Device B applied to the heel.
5943|NCT02811965|O5|Outcome|Offloading Device A|Pressure mapping is performed with Offloading Device A applied to the heel.
5944|NCT02811965|O4|Outcome|Heel Foam Pillow|Pressure mapping is performed with the heel foam pillow device applied to the heel.
5945|NCT02811965|O3|Outcome|Pillow Condition 2|Pressure mapping is performed with the Pillow condition 2 applied to the heel.
5946|NCT02811965|O2|Outcome|Pillow Condition 1|Pressure mapping is performed with the Pillow condition 1 intervention applied to the heel.
5947|NCT02811965|O1|Outcome|Control|Pressure mapping is performed without a heel offloading intervention applied.
5948|NCT02811965|O7|Outcome|Offloading Device C|Pressure mapping is performed with Offloading Device C applied to the heel.
5949|NCT02811965|O6|Outcome|Offloading Device B|Pressure mapping is performed with Offloading Device B applied to the heel.
5950|NCT02811965|O5|Outcome|Offloading Device A|Pressure mapping is performed with Offloading Device A applied to the heel.
5951|NCT02811965|O4|Outcome|Heel Foam Pillow|Pressure mapping is performed with the heel foam pillow device applied to the heel.
5952|NCT02811965|O3|Outcome|Pillow Condition 2|Pressure mapping is performed with the Pillow condition 2 applied to the heel.
5953|NCT02811965|O2|Outcome|Pillow Condition 1|Pressure mapping is performed with the Pillow condition 1 intervention applied to the heel.
5954|NCT02811965|O1|Outcome|Control|Pressure mapping is performed without a heel offloading intervention applied.
5955|NCT02811965|E7|Reported Event|Offloading Device C|Pressure mapping is performed with Offloading Device C applied to the heel.
5956|NCT02811965|E6|Reported Event|Offloading Device B|Pressure mapping is performed with Offloading Device B applied to the heel.
5960|NCT02811965|E2|Reported Event|Pillow Condition 1|Pressure mapping is performed with the Pillow condition 1 intervention applied to the heel.
5961|NCT02811965|E1|Reported Event|Control|Pressure mapping is performed without a heel offloading intervention applied.
5962|NCT02810873|B3|Baseline|Total|Total of all reporting groups
5963|NCT02810873|B2|Baseline|No F-18-FDG Scan|"STAGE II: Patients with a positive biopsy, but no fludeoxyglucose F18 scan undergo a breast fludeoxyglucose F18-labeled PEM Positron Emission Mammography scan followed by a breast copper Cu 64 TP3805-labeled PEM scan.~Positron Emission Mammography: Undergo PEM Positron Emission Mammography scan~Positron Emission Tomography: Undergo PET Positron Emission Tomography scan~Fludeoxyglucose F-18: Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan~Copper Cu 64 TP3805: Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan"
5964|NCT02810873|B1|Baseline|F-18-FDG Whole-body Scan|"STAGE I: Patients with a positive biopsy and abnormal (positive) fludeoxyglucose F18-labeled PET whole-body scan undergo a whole-body copper Cu 64 TP3805-labeled PET scan.~Positron Emission Mammography: Undergo PEM Positron Emission Mammography scan~Positron Emission Tomography: Undergo PET Positron Emission Tomography scan~Fludeoxyglucose F-18: Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan~Copper Cu 64 TP3805: Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan"
5965|NCT02810873|P2|Participant Flow|No F-18-FDG Scan|"STAGE II: Patients with a positive biopsy, but no fludeoxyglucose F18 scan undergo a breast fludeoxyglucose F18-labeled PEM Positron Emission Mammography scan followed by a breast copper Cu 64 TP3805-labeled PEM scan.~Positron Emission Mammography: Undergo PEM Positron Emission Mammography scan~Positron Emission Tomography: Undergo PET Positron Emission Tomography scan~Fludeoxyglucose F-18: Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan~Copper Cu 64 TP3805: Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan"
5966|NCT02810873|P1|Participant Flow|F-18-FDG Whole-body Scan|STAGE I: Patients with a positive biopsy and abnormal (positive) fludeoxyglucose F18-labeled PET whole-body scan undergo a whole-body copper Cu 64 TP3805-labeled PET scan.
5967|NCT02810873|O2|Outcome|No F-18-FDG Scan|"STAGE II: Patients with a positive biopsy, but no fludeoxyglucose F18 scan undergo a breast fludeoxyglucose F18-labeled PEM Positron Emission Mammography scan followed by a breast copper Cu 64 TP3805-labeled PEM scan.~Positron Emission Mammography: Undergo PEM Positron Emission Mammography scan~Positron Emission Tomography: Undergo PET Positron Emission Tomography scan~Fludeoxyglucose F-18: Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan~Copper Cu 64 TP3805: Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan"
5968|NCT02810873|O1|Outcome|F-18-FDG Whole-body Scan|STAGE I: Patients with a positive biopsy and abnormal (positive) fludeoxyglucose F18-labeled PET whole-body scan undergo a whole-body copper Cu 64 TP3805-labeled PET scan.
5969|NCT02810873|O2|Outcome|No F-18-FDG Scan|"STAGE II: Patients with a positive biopsy, but no fludeoxyglucose F18 scan undergo a breast fludeoxyglucose F18-labeled PEM Positron Emission Mammography scan followed by a breast copper Cu 64 TP3805-labeled PEM scan.~Fludeoxyglucose F-18: Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan~Copper Cu 64 TP3805: Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan"
5970|NCT02810873|O1|Outcome|F-18-FDG Whole-body Scan|STAGE I: Patients with a positive biopsy and abnormal (positive) fludeoxyglucose F18-labeled PET whole-body scan undergo a whole-body copper Cu 64 TP3805-labeled PET scan.
5971|NCT02810873|E2|Reported Event|No F-18-FDG Scan|"STAGE II: Patients with a positive biopsy, but no fludeoxyglucose F18 scan undergo a breast fludeoxyglucose F18-labeled PEM Positron Emission Mammography scan followed by a breast copper Cu 64 TP3805-labeled PEM scan.~Positron Emission Mammography: Undergo PEM Positron Emission Mammography scan~Positron Emission Tomography: Undergo PET Positron Emission Tomography scan~Fludeoxyglucose F-18: Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan~Copper Cu 64 TP3805: Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan"
5972|NCT02810873|E1|Reported Event|F-18-FDG Whole-body Scan|"STAGE I: Patients with a positive biopsy and abnormal (positive) fludeoxyglucose F18-labeled PET whole-body scan undergo a whole-body copper Cu 64 TP3805-labeled PET scan.~Positron Emission Mammography: Undergo PEM Positron Emission Mammography scan~Positron Emission Tomography: Undergo PET Positron Emission Tomography scan~Fludeoxyglucose F-18: Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan~Copper Cu 64 TP3805: Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan"
5973|NCT02809911|B3|Baseline|Total|Total of all reporting groups
5974|NCT02809911|B2|Baseline|Active Provant|"Active Provant Treatment~Due to an error in the randomization for this study, results are based upon data only for the Initial Treatment population (those subjects treated with either active or sham at the Enrollment Visit). Data from the cross-over was not included since the majority of subjects were not crossed-over to the other treatment."
5975|NCT02809911|B1|Baseline|Sham of Provant|"Sham of Provant Therapy System~Due to an error in the randomization for this study, results are based upon data only for the Initial Treatment population (those subjects treated with either active or sham at the Enrollment Visit). Data from the cross-over was not included since the majority of subjects were not crossed-over to the other treatment."
5976|NCT02809911|P2|Participant Flow|Active Provant|"Active Provant Treatment~Provant"
5977|NCT02809911|P1|Participant Flow|Sham of Provant|"Sham of Provant Therapy System~Provant"
5978|NCT02809911|O2|Outcome|Active Provant|"Active Provant Treatment~Provant"
5979|NCT02809911|O1|Outcome|Sham of Provant|"Sham of Provant Therapy System~Provant"
5980|NCT02809911|O2|Outcome|Active Provant|"Active Provant Treatment~Provant"
5981|NCT02809911|O1|Outcome|Sham of Provant|"Sham of Provant Therapy System~Provant"
5982|NCT02809911|E2|Reported Event|Active Provant|"Active Provant Treatment~Provant"
5983|NCT02809911|E1|Reported Event|Sham of Provant|"Sham of Provant Therapy System~Provant"
6118|NCT02806505|B2|Baseline|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
20033|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
5984|NCT02809833|B1|Baseline|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
5985|NCT02809833|P1|Participant Flow|Tocilizumab for Rheumatoid Arthritis (RA) in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to the Summary of Product Characteristics (SmPC) were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion at 4-week intervals.
5986|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
5987|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
5988|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
5989|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
5990|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
5991|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
5992|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
5993|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
5994|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
5995|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
5996|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
5997|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
5998|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
5999|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6000|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6119|NCT02806505|B1|Baseline|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
6001|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6002|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6003|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6004|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6005|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6006|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6007|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6008|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6009|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6010|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6011|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6012|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6013|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6014|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6015|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6016|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6017|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6018|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6019|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6020|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6021|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6022|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6023|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6024|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6025|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6026|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6027|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6028|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6029|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6030|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6031|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6032|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6033|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6034|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6035|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6036|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6037|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6038|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6039|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6040|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6041|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6042|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6043|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6044|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6045|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6046|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6047|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6048|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6049|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6050|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6051|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6052|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6053|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6054|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6055|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6056|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6057|NCT02809833|E1|Reported Event|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
6058|NCT02808130|B7|Baseline|Total|Total of all reporting groups
6059|NCT02808130|B6|Baseline|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6060|NCT02808130|B5|Baseline|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6061|NCT02808130|B4|Baseline|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6062|NCT02808130|B3|Baseline|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6063|NCT02808130|B2|Baseline|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6064|NCT02808130|B1|Baseline|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6065|NCT02808130|P6|Participant Flow|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6120|NCT02806505|P2|Participant Flow|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
6066|NCT02808130|P5|Participant Flow|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6067|NCT02808130|P4|Participant Flow|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6068|NCT02808130|P3|Participant Flow|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6069|NCT02808130|P2|Participant Flow|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6070|NCT02808130|P1|Participant Flow|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6071|NCT02808130|O6|Outcome|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6072|NCT02808130|O5|Outcome|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6073|NCT02808130|O4|Outcome|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6074|NCT02808130|O3|Outcome|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6075|NCT02808130|O2|Outcome|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6076|NCT02808130|O1|Outcome|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6077|NCT02808130|O6|Outcome|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6078|NCT02808130|O5|Outcome|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6079|NCT02808130|O4|Outcome|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6080|NCT02808130|O3|Outcome|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6081|NCT02808130|O2|Outcome|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6082|NCT02808130|O1|Outcome|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6083|NCT02808130|O6|Outcome|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6165|NCT02802592|O1|Outcome|Epogen|"1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr~Epogen: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm"
6084|NCT02808130|O5|Outcome|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6085|NCT02808130|O4|Outcome|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6086|NCT02808130|O3|Outcome|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6087|NCT02808130|O2|Outcome|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6088|NCT02808130|O1|Outcome|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6089|NCT02808130|E6|Reported Event|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6090|NCT02808130|E5|Reported Event|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6091|NCT02808130|E4|Reported Event|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6121|NCT02806505|P1|Participant Flow|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
6122|NCT02806505|O2|Outcome|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
6166|NCT02802592|O2|Outcome|Normal Saline|"250 ml normal saline infused over 1 hr~Normal Saline: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm"
6092|NCT02808130|E3|Reported Event|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6093|NCT02808130|E2|Reported Event|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6094|NCT02808130|E1|Reported Event|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
6095|NCT02806869|B3|Baseline|Total|Total of all reporting groups
6096|NCT02806869|B2|Baseline|Arm #2 – Fed State, 2 Study Visits|"Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red~Washout period of at least 7 days~Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red"
6097|NCT02806869|B1|Baseline|Arm #1 – Fasting State, 2 Study Visits|"Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red~Washout period of at least 7 days~Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red"
6098|NCT02806869|P2|Participant Flow|Arm #2 – Fed State, 2 Study Visits|"Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red~Washout period of at least 7 days~Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red"
6099|NCT02806869|P1|Participant Flow|Arm #1 – Fasting State, 2 Study Visits|"Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red~Washout period of at least 7 days~Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red"
6100|NCT02806869|O2|Outcome|Arm #2 – Fed State, 2 Study Visits|"Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red~Washout period of at least 7 days~Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red"
6101|NCT02806869|O1|Outcome|Arm #1 – Fasting State, 2 Study Visits|"Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red~Washout period of at least 7 days~Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red"
6102|NCT02806869|O2|Outcome|Arm #2 – Fed State, 2 Study Visits|"Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red~Washout period of at least 7 days~Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red"
6103|NCT02806869|O1|Outcome|Arm #1 – Fasting State, 2 Study Visits|"Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red~Washout period of at least 7 days~Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red"
6104|NCT02806869|O2|Outcome|Arm #2 – Fed State, 2 Study Visits|"Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red~Washout period of at least 7 days~Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red"
6105|NCT02806869|O1|Outcome|Arm #1 – Fasting State, 2 Study Visits|"Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red~Washout period of at least 7 days~Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red"
6106|NCT02806869|E2|Reported Event|Arm #2 – Fed State, 2 Study Visits|"Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red~Washout period of at least 7 days~Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red"
6107|NCT02806869|E1|Reported Event|Arm #1 – Fasting State, 2 Study Visits|"Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red~Washout period of at least 7 days~Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red"
6108|NCT02806544|B1|Baseline|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
6109|NCT02806544|P1|Participant Flow|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
6110|NCT02806544|O1|Outcome|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
6111|NCT02806544|O1|Outcome|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
6112|NCT02806544|O1|Outcome|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
6113|NCT02806544|O1|Outcome|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
6114|NCT02806544|O1|Outcome|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
6115|NCT02806544|O1|Outcome|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
6123|NCT02806505|O1|Outcome|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
6124|NCT02806505|O2|Outcome|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
6125|NCT02806505|O1|Outcome|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
6126|NCT02806505|O2|Outcome|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
6127|NCT02806505|O1|Outcome|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
6128|NCT02806505|E2|Reported Event|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
6129|NCT02806505|E1|Reported Event|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
6130|NCT02805907|B3|Baseline|Total|Total of all reporting groups
6131|NCT02805907|B2|Baseline|Control Group (CG)|"Placebo in a presentation with an identical appearance taken weekly by the oral route~Placebo"
6132|NCT02805907|B1|Baseline|Intervention Group (IG)|"Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route~Calcifediol"
6133|NCT02805907|P2|Participant Flow|Control Group (CG)|"Placebo in a presentation with an identical appearance taken weekly by the oral route~Placebo"
6134|NCT02805907|P1|Participant Flow|Intervention Group (IG)|"Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route~Calcifediol"
6135|NCT02805907|O2|Outcome|Control Group (CG)|"Placebo in a presentation with an identical appearance taken weekly by the oral route~Placebo"
6136|NCT02805907|O1|Outcome|Intervention Group (IG)|"Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route~Calcifediol"
6137|NCT02805907|O2|Outcome|Control Group (CG)|"Placebo in a presentation with an identical appearance taken weekly by the oral route~Placebo"
6138|NCT02805907|O1|Outcome|Intervention Group (IG)|"Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route~Calcifediol"
6139|NCT02805907|O2|Outcome|Control Group (CG)|"Placebo in a presentation with an identical appearance taken weekly by the oral route~Placebo"
6140|NCT02805907|O1|Outcome|Intervention Group (IG)|"Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route~Calcifediol"
6141|NCT02805907|O2|Outcome|Control Group (CG)|"Placebo in a presentation with an identical appearance taken weekly by the oral route~Placebo"
6142|NCT02805907|O1|Outcome|Intervention Group (IG)|"Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route~Calcifediol"
6143|NCT02805907|E2|Reported Event|Control Group (CG)|"Placebo in a presentation with an identical appearance taken weekly by the oral route~Placebo"
6144|NCT02805907|E1|Reported Event|Intervention Group (IG)|"Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route~Calcifediol"
6145|NCT02802878|B3|Baseline|Total|Total of all reporting groups
6146|NCT02802878|B2|Baseline|Low Intensity Exercise|"40% max isokinetic training in same repetitions/sets as experimental group.~Isokinetic Training with Computer Sports Medicine Inc. (CSMi) HUMAC NORM: Low intensity exercises completed using CSMi HUMAC NORM in isokinetic mode at approximately 40%1 RM."
6147|NCT02802878|B1|Baseline|Hybrid Training|"The hybrid training system combines the applications of neuromuscular electrical stimulation (NMES) with voluntary contractions (NMES-VC). Training will be performed in a seated position with feet not touching the ground, and will involve each knee flexing and extending alternately. The joint range of motion will be restricted to a 90º arc from approximately 10º to 100º of flexion. Each session will consist of 5 sets of 10 repetitions, 3-second knee flexion and extension contractions on each leg. Sets will be separated by 30-sec rest intervals.~Electrodes will be placed on the anterior thigh over the motor points of the bilateral vastus medialis and lateralis, and over the medial and lateral hamstrings on the posterior thigh. Electrical stimulation intensity will be set to approximately 40% of 1 repetition maximum (RM). A joint motion sensor will trigger stimulation of the antagonist once it senses the initiation of volitional contraction of the agonist muscle group."
6148|NCT02802878|P2|Participant Flow|Low Intensity Exercise|"40% max isokinetic training in same repetitions/sets as experimental group.~Isokinetic Training with Computer Sports Medicine Inc. (CSMi) HUMAC NORM: Low intensity exercises completed using CSMi HUMAC NORM in isokinetic mode at approximately 40%1 RM."
6149|NCT02802878|P1|Participant Flow|Hybrid Training|"The hybrid training system combines the applications of neuromuscular electrical stimulation (NMES) with voluntary contractions (NMES-VC). Training will be performed in a seated position with feet not touching the ground, and will involve each knee flexing and extending alternately. The joint range of motion will be restricted to a 90º arc from approximately 10º to 100º of flexion. Each session will consist of 5 sets of 10 repetitions, 3-second knee flexion and extension contractions on each leg. Sets will be separated by 30-sec rest intervals.~Electrodes will be placed on the anterior thigh over the motor points of the bilateral vastus medialis and lateralis, and over the medial and lateral hamstrings on the posterior thigh. Electrical stimulation intensity will be set to approximately 40% of 1 repetition maximum (RM). A joint motion sensor will trigger stimulation of the antagonist once it senses the initiation of volitional contraction of the agonist muscle group."
6150|NCT02802878|O2|Outcome|Low Intensity Exercise|Isokinetic Training with isokinetic dynamometer. Low intensity exercises completed in isokinetic mode at approximately 40%1 RM in same repetitions/sets as experimental group.
6163|NCT02802592|P1|Participant Flow|All Participants|"1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr Epogen: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm~OR~250 ml normal saline infused over 1 hr Normal Saline: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm"
6164|NCT02802592|O2|Outcome|Normal Saline|"250 ml normal saline infused over 1 hr~Normal Saline: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm"
6151|NCT02802878|O1|Outcome|Hybrid Training|"The hybrid training system combines the applications of neuromuscular electrical stimulation (NMES) with voluntary contractions (NMES-VC). Training will be performed in a seated position with feet not touching the ground, and will involve each knee flexing and extending alternately. The joint range of motion will be restricted to a 90º arc from approximately 10º to 100º of flexion. Each session will consist of 5 sets of 10 repetitions, 3-second knee flexion and extension contractions on each leg. Sets will be separated by 30-sec rest intervals.~Electrodes will be placed on the anterior thigh over the motor points of the bilateral vastus medialis and lateralis, and over the medial and lateral hamstrings on the posterior thigh. Electrical stimulation intensity will be set to approximately 40% of 1 repetition maximum (RM). A joint motion sensor will trigger stimulation of the antagonist once it senses the initiation of volitional contraction of the agonist muscle group."
6152|NCT02802878|O2|Outcome|Low Intensity Exercise|Isokinetic Training with isokinetic dynamometer. Low intensity exercises completed in isokinetic mode at approximately 40%1 RM in same repetitions/sets as experimental group.
6153|NCT02802878|O1|Outcome|Hybrid Training|"The hybrid training system combines the applications of neuromuscular electrical stimulation (NMES) with voluntary contractions (NMES-VC). Training will be performed in a seated position with feet not touching the ground, and will involve each knee flexing and extending alternately. The joint range of motion will be restricted to a 90º arc from approximately 10º to 100º of flexion. Each session will consist of 5 sets of 10 repetitions, 3-second knee flexion and extension contractions on each leg. Sets will be separated by 30-sec rest intervals.~Electrodes will be placed on the anterior thigh over the motor points of the bilateral vastus medialis and lateralis, and over the medial and lateral hamstrings on the posterior thigh. Electrical stimulation intensity will be set to approximately 40% of 1 repetition maximum (RM). A joint motion sensor will trigger stimulation of the antagonist once it senses the initiation of volitional contraction of the agonist muscle group."
6154|NCT02802878|O2|Outcome|Low Intensity Exercise|Isokinetic Training with isokinetic dynamometer. Low intensity exercises completed in isokinetic mode at approximately 40%1 RM in same repetitions/sets as experimental group.
6155|NCT02802878|O1|Outcome|Hybrid Training|"The hybrid training system combines the applications of neuromuscular electrical stimulation (NMES) with voluntary contractions (NMES-VC). Training will be performed in a seated position with feet not touching the ground, and will involve each knee flexing and extending alternately. The joint range of motion will be restricted to a 90º arc from approximately 10º to 100º of flexion. Each session will consist of 5 sets of 10 repetitions, 3-second knee flexion and extension contractions on each leg. Sets will be separated by 30-sec rest intervals.~Electrodes will be placed on the anterior thigh over the motor points of the bilateral vastus medialis and lateralis, and over the medial and lateral hamstrings on the posterior thigh. Electrical stimulation intensity will be set to approximately 40% of 1 repetition maximum (RM). A joint motion sensor will trigger stimulation of the antagonist once it senses the initiation of volitional contraction of the agonist muscle group."
6156|NCT02802878|O2|Outcome|Low Intensity Exercise|Isokinetic Training with isokinetic dynamometer. Low intensity exercises completed in isokinetic mode at approximately 40%1 RM in same repetitions/sets as experimental group.
6157|NCT02802878|O1|Outcome|Hybrid Training|"The hybrid training system combines the applications of neuromuscular electrical stimulation (NMES) with voluntary contractions (NMES-VC). Training will be performed in a seated position with feet not touching the ground, and will involve each knee flexing and extending alternately. The joint range of motion will be restricted to a 90º arc from approximately 10º to 100º of flexion. Each session will consist of 5 sets of 10 repetitions, 3-second knee flexion and extension contractions on each leg. Sets will be separated by 30-sec rest intervals.~Electrodes will be placed on the anterior thigh over the motor points of the bilateral vastus medialis and lateralis, and over the medial and lateral hamstrings on the posterior thigh. Electrical stimulation intensity will be set to approximately 40% of 1 repetition maximum (RM). A joint motion sensor will trigger stimulation of the antagonist once it senses the initiation of volitional contraction of the agonist muscle group."
6158|NCT02802878|O2|Outcome|Low Intensity Exercise|Isokinetic Training with isokinetic dynamometer. Low intensity exercises completed in isokinetic mode at approximately 40%1 RM in same repetitions/sets as experimental group.
6159|NCT02802878|O1|Outcome|Hybrid Training|"The hybrid training system combines the applications of neuromuscular electrical stimulation (NMES) with voluntary contractions (NMES-VC). Training will be performed in a seated position with feet not touching the ground, and will involve each knee flexing and extending alternately. The joint range of motion will be restricted to a 90º arc from approximately 10º to 100º of flexion. Each session will consist of 5 sets of 10 repetitions, 3-second knee flexion and extension contractions on each leg. Sets will be separated by 30-sec rest intervals.~Electrodes will be placed on the anterior thigh over the motor points of the bilateral vastus medialis and lateralis, and over the medial and lateral hamstrings on the posterior thigh. Electrical stimulation intensity will be set to approximately 40% of 1 repetition maximum (RM). A joint motion sensor will trigger stimulation of the antagonist once it senses the initiation of volitional contraction of the agonist muscle group."
6160|NCT02802878|E2|Reported Event|Low Intensity Exercise|"40% max isokinetic training in same repetitions/sets as experimental group.~Isokinetic Training with Computer Sports Medicine Inc. (CSMi) HUMAC NORM: Low intensity exercises completed using CSMi HUMAC NORM in isokinetic mode at approximately 40%1 RM."
6161|NCT02802878|E1|Reported Event|Hybrid Training|"The hybrid training system combines the applications of neuromuscular electrical stimulation (NMES) with voluntary contractions (NMES-VC). Training will be performed in a seated position with feet not touching the ground, and will involve each knee flexing and extending alternately. The joint range of motion will be restricted to a 90º arc from approximately 10º to 100º of flexion. Each session will consist of 5 sets of 10 repetitions, 3-second knee flexion and extension contractions on each leg. Sets will be separated by 30-sec rest intervals.~Electrodes will be placed on the anterior thigh over the motor points of the bilateral vastus medialis and lateralis, and over the medial and lateral hamstrings on the posterior thigh. Electrical stimulation intensity will be set to approximately 40% of 1 repetition maximum (RM). A joint motion sensor will trigger stimulation of the antagonist once it senses the initiation of volitional contraction of the agonist muscle group."
6162|NCT02802592|B1|Baseline|All Participants|"1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr Epogen: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm~OR~250 ml normal saline infused over 1 hr Normal Saline: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm"
6167|NCT02802592|O1|Outcome|Epogen|"1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr~Epogen: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm"
6168|NCT02802592|O2|Outcome|Normal Saline|"250 ml normal saline infused over 1 hr~Normal Saline: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm"
6169|NCT02802592|O1|Outcome|Epogen|"1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr~Epogen: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm"
6170|NCT02802592|E1|Reported Event|All Participants|"1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr Epogen: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm~OR~250 ml normal saline infused over 1 hr Normal Saline: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm"
6171|NCT02802449|B3|Baseline|Total|Total of all reporting groups
6172|NCT02802449|B2|Baseline|25 Hydroxy-Vitamin D3 or [25 (OH) D3]|"The participant will be randomized then given two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] to take under direct observation at the baseline and week 2 visit.~25 Hydroxy- Vitamin D3 [25 (OH) D3]: Two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] will be given at baseline and 2 weeks after the baseline visit under direct observation by the nurse or research coordinator."
6173|NCT02802449|B1|Baseline|Placebo|"The participant will be randomized then given two tablets of Placebo (microcrystalline cellulose) to take under direct observation at the baseline and week 2 visit.~Placebo"
6174|NCT02802449|P2|Participant Flow|25 Hydroxy-Vitamin D3 or [25 (OH) D3]|"The participant will be randomized then given two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] to take under direct observation at the baseline and week 2 visit.~25 Hydroxy- Vitamin D3 [25 (OH) D3]: Two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] will be given at baseline and 2 weeks after the baseline visit under direct observation by the nurse or research coordinator."
6175|NCT02802449|P1|Participant Flow|Placebo|"The participant will be randomized then given two tablets of Placebo (microcrystalline cellulose) to take under direct observation at the baseline and week 2 visit.~Placebo"
6176|NCT02802449|O2|Outcome|25 Hydroxy-Vitamin D3 or [25 (OH) D3]|"The participant will be randomized then given two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] to take under direct observation at the baseline and week 2 visit.~25 Hydroxy- Vitamin D3 [25 (OH) D3]: Two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] will be given at baseline and 2 weeks after the baseline visit under direct observation by the nurse or research coordinator."
6177|NCT02802449|O1|Outcome|Placebo|"The participant will be randomized then given two tablets of Placebo (microcrystalline cellulose) to take under direct observation at the baseline and week 2 visit.~Placebo"
6178|NCT02802449|O2|Outcome|25 Hydroxy-Vitamin D3 or [25 (OH) D3]|"The participant will be randomized then given two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] to take under direct observation at the baseline and week 2 visit.~25 Hydroxy- Vitamin D3 [25 (OH) D3]: Two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] will be given at baseline and 2 weeks after the baseline visit under direct observation by the nurse or research coordinator."
6179|NCT02802449|O1|Outcome|Placebo|"The participant will be randomized then given two tablets of Placebo (microcrystalline cellulose) to take under direct observation at the baseline and week 2 visit.~Placebo"
6180|NCT02802449|O2|Outcome|25 Hydroxy-Vitamin D3 or [25 (OH) D3]|"The participant will be randomized then given two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] to take under direct observation at the baseline and week 2 visit.~25 Hydroxy- Vitamin D3 [25 (OH) D3]: Two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] will be given at baseline and 2 weeks after the baseline visit under direct observation by the nurse or research coordinator."
6181|NCT02802449|O1|Outcome|Placebo|"The participant will be randomized then given two tablets of Placebo (microcrystalline cellulose) to take under direct observation at the baseline and week 2 visit.~Placebo"
6182|NCT02802449|O2|Outcome|25 Hydroxy-Vitamin D3 or [25 (OH) D3]|"The participant will be randomized then given two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] to take under direct observation at the baseline and week 2 visit.~25 Hydroxy- Vitamin D3 [25 (OH) D3]: Two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] will be given at baseline and 2 weeks after the baseline visit under direct observation by the nurse or research coordinator."
6183|NCT02802449|O1|Outcome|Placebo|"The participant will be randomized then given two tablets of Placebo (microcrystalline cellulose) to take under direct observation at the baseline and week 2 visit.~Placebo"
6184|NCT02802449|O2|Outcome|25 Hydroxy-Vitamin D3 or [25 (OH) D3]|"The participant will be randomized then given two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] to take under direct observation at the baseline and week 2 visit.~25 Hydroxy- Vitamin D3 [25 (OH) D3]: Two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] will be given at baseline and 2 weeks after the baseline visit under direct observation by the nurse or research coordinator."
6185|NCT02802449|O1|Outcome|Placebo|"The participant will be randomized then given two tablets of Placebo (microcrystalline cellulose) to take under direct observation at the baseline and week 2 visit.~Placebo"
6186|NCT02802449|O2|Outcome|25 Hydroxy-Vitamin D3 or [25 (OH) D3]|"The participant will be randomized then given two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] to take under direct observation at the baseline and week 2 visit.~25 Hydroxy- Vitamin D3 [25 (OH) D3]: Two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] will be given at baseline and 2 weeks after the baseline visit under direct observation by the nurse or research coordinator."
6187|NCT02802449|O1|Outcome|Placebo|"The participant will be randomized then given two tablets of Placebo (microcrystalline cellulose) to take under direct observation at the baseline and week 2 visit.~Placebo"
6229|NCT02800213|B3|Baseline|Total|Total of all reporting groups
7029|NCT02780167|B5|Baseline|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
6188|NCT02802449|E2|Reported Event|25 Hydroxy-Vitamin D3 or [25 (OH) D3]|"The participant will be randomized then given two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] to take under direct observation at the baseline and week 2 visit.~25 Hydroxy- Vitamin D3 [25 (OH) D3]: Two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] will be given at baseline and 2 weeks after the baseline visit under direct observation by the nurse or research coordinator."
6189|NCT02802449|E1|Reported Event|Placebo|"The participant will be randomized then given two tablets of Placebo (microcrystalline cellulose) to take under direct observation at the baseline and week 2 visit.~Placebo"
6190|NCT02801396|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens.
6191|NCT02801396|P6|Participant Flow|Control/Test2/Test1|Subjects that received the Control lens during the first period, Test 2 lens during the second period and Test lens 1 during the third period.
6192|NCT02801396|P5|Participant Flow|Control/Test1/Test2|Subjects that received the Control lens during the first period, Test lens 1 during the second period and Test lens 2 during the third period.
6193|NCT02801396|P4|Participant Flow|Test2/Control/Test1|Subjects that received Test lens 2 during the first period, the Control lens during the second and the Test 1 lens during the third period.
6194|NCT02801396|P3|Participant Flow|Test2/Test1/Control|Subjects that received Test lens 2 during the first period, Test lens 1 during the second period and the Control lens during the third period.
6195|NCT02801396|P2|Participant Flow|Test1/Control/Test2|Subjects that received Test lens 1 during the first period, the Control lens during the second period and Test lens 2 during the third period.
6196|NCT02801396|P1|Participant Flow|Test1/Test2/Control|Subjects that received Test lens 1 during the first period, Test lens 2 during the second period and the Control lens during the third period.
6197|NCT02801396|O3|Outcome|Control|Subjects that wore the control lens during any of the 3 study periods.
6198|NCT02801396|O2|Outcome|Test 2|Subjects that wore the Test 2 lens during any of the 3 study periods.
6199|NCT02801396|O1|Outcome|Test1|Subjects that wore the Test 1 lens during any of the 3 study periods.
6200|NCT02801396|O3|Outcome|Control|Subjects that wore the control lens during any of the 3 study periods.
6201|NCT02801396|O2|Outcome|Test 2|Subjects that wore the Test 2 lens during any of the 3 study periods.
6202|NCT02801396|O1|Outcome|Test1|Subjects that wore the Test 1 lens during any of the 3 study periods.
6203|NCT02801396|O3|Outcome|Control|Subjects that wore the control lens during any of the 3 study periods.
6204|NCT02801396|O2|Outcome|Test 2|Subjects that wore the Test 2 lens during any of the 3 study periods.
6205|NCT02801396|O1|Outcome|Test1|Subjects that wore the Test 1 lens during any of the 3 study periods.
6206|NCT02801396|O3|Outcome|Control|Subjects that wore the control lens during any of the 3 study periods.
6207|NCT02801396|O2|Outcome|Test 2|Subjects that wore the Test 2 lens during any of the 3 study periods.
6208|NCT02801396|O1|Outcome|Test1|Subjects that wore the Test 1 lens during any of the 3 study periods.
6209|NCT02801396|E3|Reported Event|Control|Subjects that wore the control lens during any of the 3 study periods.
6210|NCT02801396|E2|Reported Event|Test2|Subjects that wore the Test 2 lens during any of the 3 periods.
6211|NCT02801396|E1|Reported Event|Test1|Subjects that wore the Test 1 lens during any of the 3 study periods.
6212|NCT02801006|B1|Baseline|Overall Study|Total participants enrolled
6213|NCT02801006|P2|Participant Flow|Etafilcon A First, Then Stenfilcon A|Participants randomized to wear stenfilcon A toric lens pair for two weeks then etafilcon A toric lens pair in the cross over study.
6214|NCT02801006|P1|Participant Flow|Stenfilcon A First, Then Etafilcon A|Participants randomized to wear stenfilcon A toric lens pair for two weeks then etafilcon A toric lens pair in the cross over study.
6215|NCT02801006|O2|Outcome|Etafilcon A|"Participants randomized to wear etafilcon A toric lens pair (either first of second) for two weeks during the cross over study.~etafilcon A: contact lens"
6216|NCT02801006|O1|Outcome|Stenfilcon A|"Participants randomized to wear stenfilcon A toric lens pair (either first or second) for two weeks during the cross over study.~stenfilcon A: contact lens"
6217|NCT02801006|O2|Outcome|Etafilcon A|"Participants randomized to wear etafilcon A toric lens pair (either first of second) for two weeks during the cross over study.~etafilcon A: contact lens"
6218|NCT02801006|O1|Outcome|Stenfilcon A|"Participants randomized to wear stenfilcon A toric lens pair (either first or second) for two weeks during the cross over study.~stenfilcon A: contact lens"
6219|NCT02801006|O2|Outcome|Etafilcon A|"Participants randomized to wear etafilcon A toric lens pair (either first of second) for two weeks during the cross over study.~etafilcon A: contact lens"
6220|NCT02801006|O1|Outcome|Stenfilcon A|"Participants randomized to wear stenfilcon A toric lens pair (either first or second) for two weeks during the cross over study.~stenfilcon A: contact lens"
6221|NCT02801006|O2|Outcome|Etafilcon A|"Participants randomized to wear etafilcon A toric lens pair (either first or second) for two weeks during the cross over study.~etafilcon A: contact lens"
6222|NCT02801006|O1|Outcome|Stenfilcon A|"Participants randomized to wear stenfilcon A toric lens pair (either first or second) for two weeks during the cross over study.~stenfilcon A: contact lens"
6223|NCT02801006|O2|Outcome|Etafilcon A|"Participants randomized to wear etafilcon A toric lens pair (either first or second) for two weeks during the cross over study.~etafilcon A: contact lens"
6224|NCT02801006|O1|Outcome|Stenfilcon A|"Participants randomized to wear stenfilcon A toric lens pair (either first or second) for two weeks during the cross over study.~stenfilcon A: contact lens"
6225|NCT02801006|O2|Outcome|Etafilcon A Toric|"Participants randomized to wear etafilcon A lens pair (either first of second) for two weeks during the cross over study.~etafilcon A: contact lens"
6226|NCT02801006|O1|Outcome|Stenfilcon A|"Participants randomized to wear stenfilcon A toric lens pair (either first or second) for two weeks during the cross over study.~stenfilcon A: contact lens"
6227|NCT02801006|E2|Reported Event|Etafilcon A|Participants randomized to wear etafilcon A lens pair either as first or second pair in this crossover study.
6228|NCT02801006|E1|Reported Event|Stenfilcon A|Participants randomized to wear stenfilcon A lens pair either as first or second pair in this crossover study.
6230|NCT02800213|B2|Baseline|Conventional Then Modified Ambu Spur II Bag Valve Mask|"A health volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).~Conventional Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask.~After completion, subjects repeat all these procedures using the modified Ambu Spur II bag valve mask."
6231|NCT02800213|B1|Baseline|Modified Then Conventional Ambu Spur II Bag Valve Mask|"A health volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).~Modified Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with a supplemental external handle.~After completion, subjects repeat all these procedures using a conventional Ambu Spur II bag valve mask."
6232|NCT02800213|P2|Participant Flow|Conventional Then Modified Ambu Spur II Bag Valve Mask|"A health volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).~Conventional Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask~After completion, subjects repeat all these procedures using the modified Ambu Spur II bag valve mask."
6233|NCT02800213|P1|Participant Flow|Modified Then Conventional Ambu Spur II Bag Valve Mask|"A health volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).~Modified Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with a supplemental external handle.~After completion, subjects repeat all these procedures using a conventional Ambu Spur II bag valve mask."
6234|NCT02800213|O2|Outcome|Conventional Bag Valve Mask|"A health volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).~Conventional Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask.~After completion, subjects repeat all these procedures using the modified Ambu Spur II bag valve mask."
6235|NCT02800213|O1|Outcome|Modified Ambu Spur II Bag Valve Mask|"A health volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).~Modified Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with a supplemental external handle.~After completion, subjects repeat all these procedures using a conventional Ambu Spur II bag valve mask."
6236|NCT02800213|E2|Reported Event|Conventional Ambu Spur II Bag Valve Mask|"A health volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).~Conventional Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask.~After completion, subjects repeat all these procedures using the modified Ambu Spur II bag valve mask."
6237|NCT02800213|E1|Reported Event|Modified Ambu Spur II Bag Valve Mask|"A health volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).~Modified Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with a supplemental external handle.~After completion, subjects repeat all these procedures using a conventional Ambu Spur II bag valve mask."
6238|NCT02799082|B3|Baseline|Total|Total of all reporting groups
6239|NCT02799082|B2|Baseline|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6240|NCT02799082|B1|Baseline|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6241|NCT02799082|P2|Participant Flow|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6242|NCT02799082|P1|Participant Flow|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6243|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6244|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6245|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6392|NCT02798289|O1|Outcome|Active - Device|The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production following study enrollment. Oculeve Intranasal Neurostimulator: Neurostimulation device
6246|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6247|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6248|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6249|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6250|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6251|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6252|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6253|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6254|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6255|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6256|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6257|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6258|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6259|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6260|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6261|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6262|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6263|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6393|NCT02798289|E1|Reported Event|Active - Device|The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production once following study enrollment. Oculeve Intranasal Neurostimulator: Neurostimulation device
6264|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6265|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6266|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6267|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6268|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6269|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6270|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6271|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6272|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6273|NCT02799082|E2|Reported Event|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6274|NCT02799082|E1|Reported Event|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
6275|NCT02799069|B4|Baseline|Total|Total of all reporting groups
6276|NCT02799069|B3|Baseline|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6277|NCT02799069|B2|Baseline|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6278|NCT02799069|B1|Baseline|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6279|NCT02799069|P3|Participant Flow|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6280|NCT02799069|P2|Participant Flow|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6281|NCT02799069|P1|Participant Flow|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6282|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6394|NCT02797080|B1|Baseline|Interferon γ-1b|SC ACTIMMUNE® TIW at an individualized dose
6283|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6284|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6285|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6286|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6287|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6288|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6289|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6290|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6291|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6292|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6293|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6294|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6295|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6296|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6297|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6298|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6299|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6300|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6395|NCT02797080|P1|Participant Flow|Interferon γ-1b|Subcutaneous (SC) ACTIMMUNE® 3 times a week (TIW) at an individualized dose.
20034|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
6301|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6302|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6303|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6304|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6305|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6306|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6307|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6308|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6309|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6310|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6311|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6312|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6313|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6314|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6315|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6316|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6317|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6318|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6396|NCT02797080|O1|Outcome|Interferon γ-1b|SC ACTIMMUNE® TIW at an individualized dose
6397|NCT02797080|E1|Reported Event|Interferon γ-1b|SC ACTIMMUNE® TIW at an individualized dose
6319|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6320|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6321|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6322|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6323|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6324|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6325|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6326|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6327|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6328|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6329|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6330|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6331|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6332|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6333|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6334|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6335|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6336|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6398|NCT02796963|B5|Baseline|Total|Total of all reporting groups
7680|NCT02756624|O2|Outcome|AC-170 Vehicle|"1 drop in each eye 3 times daily for up to 6 weeks~AC-170 Vehicle"
6337|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6338|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6339|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6340|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6341|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6342|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6343|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6344|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6345|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6346|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6347|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6348|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6349|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6350|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6351|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6352|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6353|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6354|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6506|NCT02796092|P2|Participant Flow|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
6355|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6356|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6357|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6358|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6359|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6360|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6361|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6362|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6363|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6364|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6365|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6366|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6367|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6368|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6369|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6370|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6371|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6372|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6507|NCT02796092|P1|Participant Flow|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
6373|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6374|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6375|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6376|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6377|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6378|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6379|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6380|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6381|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6382|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6383|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6384|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6385|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6386|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6387|NCT02799069|E3|Reported Event|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6388|NCT02799069|E2|Reported Event|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6389|NCT02799069|E1|Reported Event|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
6390|NCT02798289|B1|Baseline|Active - Device|The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production following study enrollment. Oculeve Intranasal Neurostimulator: Neurostimulation device
6391|NCT02798289|P1|Participant Flow|Active - Device|The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production following study enrollment. Oculeve Intranasal Neurostimulator: Neurostimulation device
7681|NCT02756624|O1|Outcome|AC-170 0.24%|"1 drop in each eye 3 times daily for up to 6 weeks~AC-170 0.24%"
6399|NCT02796963|B4|Baseline|Delayed Intervention 3|Shenzhen and Jining city. Intervention in months 10-12: A crowdsourcing contest to solicit optimal images/concepts/taglines; a designathon to formulate optimal HIV testing campaigns; a process of localization unique to each of the eight cities.
6400|NCT02796963|B3|Baseline|Delayed Intervention 2|Zhuhai and Qingdao city. Intervention in months 7-9: A crowdsourcing contest to solicit optimal images/concepts/taglines; a designathon to formulate optimal HIV testing campaigns; a process of localization unique to each of the eight cities.
6401|NCT02796963|B2|Baseline|Delayed Intervention 1|Jiangmen and Jinan city. Intervention in months 4-6: A crowdsourcing contest to solicit optimal images/concepts/taglines; a designathon to formulate optimal HIV testing campaigns; a process of localization unique to each of the eight cities.
6402|NCT02796963|B1|Baseline|Immediate Intervention|Guangzhou and Yantai city. Intervention in months 1-3: A crowdsourcing contest to solicit optimal images/concepts/taglines; a designathon to formulate optimal HIV testing campaigns; a process of localization unique to each of the eight cities.
6403|NCT02796963|P4|Participant Flow|Delayed Intervention 3|"Based on the pre-determined randomization schedule, 354 participants from Shenzhen and Jining were assigned to delayed intervention group 3 to receive a crowdsourced intervention in months 10-12.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6404|NCT02796963|P3|Participant Flow|Delayed Intervention 2|"Based on the pre-determined randomization schedule, 316 participants from Zhuhai and Qingdao were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 7-9.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6405|NCT02796963|P2|Participant Flow|Delayed Intervention 1|"Based on the pre-determined randomization schedule, 328 participants from Jiangmen and Jinan were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 4-6.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6406|NCT02796963|P1|Participant Flow|Immediate Intervention|"Based on the pre-determined randomization schedule, 383 participants from Guangzhou and Yantai were assigned to the first intervention group to receive a crowdsourced intervention in months 1-3.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6407|NCT02796963|O4|Outcome|Delayed Intervention 3|"Based on the pre-determined randomization schedule, 354 participants from Shenzhen and Jining were assigned to delayed intervention group 3 to receive a crowdsourced intervention in months 10-12.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6408|NCT02796963|O3|Outcome|Delayed Intervention 2|"Based on the pre-determined randomization schedule, 316 participants from Zhuhai and Qingdao were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 7-9.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6409|NCT02796963|O2|Outcome|Delayed Intervention 1|"Based on the pre-determined randomization schedule, 328 participants from Jiangmen and Jinan were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 4-6.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6410|NCT02796963|O1|Outcome|Immediate Intervention|"Based on the pre-determined randomization schedule, 383 participants from Guangzhou and Yantai were assigned to the first intervention group to receive a crowdsourced intervention in months 1-3.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6411|NCT02796963|O4|Outcome|Delayed Intervention 3|"Based on the pre-determined randomization schedule, 354 participants from Shenzhen and Jining were assigned to delayed intervention group 3 to receive a crowdsourced intervention in months 10-12.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6412|NCT02796963|O3|Outcome|Delayed Intervention 2|"Based on the pre-determined randomization schedule, 316 participants from Zhuhai and Qingdao were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 7-9.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6476|NCT02796651|O3|Outcome|Formoterol Fumarate (FF) 24 μg|Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
9997|NCT02701361|O1|Outcome|All Eligible Participants|All eligible participants.
6413|NCT02796963|O2|Outcome|Delayed Intervention 1|"Based on the pre-determined randomization schedule, 328 participants from Jiangmen and Jinan were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 4-6.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6414|NCT02796963|O1|Outcome|Immediate Intervention|"Based on the pre-determined randomization schedule, 383 participants from Guangzhou and Yantai were assigned to the first intervention group to receive a crowdsourced intervention in months 1-3.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6415|NCT02796963|O4|Outcome|Delayed Intervention 3|"Based on the pre-determined randomization schedule, 354 participants from Shenzhen and Jining were assigned to delayed intervention group 3 to receive a crowdsourced intervention in months 10-12.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6416|NCT02796963|O3|Outcome|Delayed Intervention 2|"Based on the pre-determined randomization schedule, 316 participants from Zhuhai and Qingdao were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 7-9.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6417|NCT02796963|O2|Outcome|Delayed Intervention 1|"Based on the pre-determined randomization schedule, 328 participants from Jiangmen and Jinan were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 4-6.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6418|NCT02796963|O1|Outcome|Immediate Intervention|"Based on the pre-determined randomization schedule, 383 participants from Guangzhou and Yantai were assigned to the first intervention group to receive a crowdsourced intervention in months 1-3.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6419|NCT02796963|O4|Outcome|Delayed Intervention 3|"Based on the pre-determined randomization schedule, 354 participants from Shenzhen and Jining were assigned to delayed intervention group 3 to receive a crowdsourced intervention in months 10-12.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6420|NCT02796963|O3|Outcome|Delayed Intervention 2|"Based on the pre-determined randomization schedule, 316 participants from Zhuhai and Qingdao were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 7-9.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6421|NCT02796963|O2|Outcome|Delayed Intervention 1|"Based on the pre-determined randomization schedule, 328 participants from Jiangmen and Jinan were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 4-6.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6422|NCT02796963|O1|Outcome|Immediate Intervention|"Based on the pre-determined randomization schedule, 383 participants from Guangzhou and Yantai were assigned to the first intervention group to receive a crowdsourced intervention in months 1-3.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6423|NCT02796963|O4|Outcome|Delayed Intervention 3|"Based on the pre-determined randomization schedule, 354 participants from Shenzhen and Jining were assigned to delayed intervention group 3 to receive a crowdsourced intervention in months 10-12.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6424|NCT02796963|O3|Outcome|Delayed Intervention 2|"Based on the pre-determined randomization schedule, 316 participants from Zhuhai and Qingdao were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 7-9.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6477|NCT02796651|O2|Outcome|Formoterol Fumarate (FF) 12 μg|Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 12 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
6508|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
6425|NCT02796963|O2|Outcome|Delayed Intervention 1|"Based on the pre-determined randomization schedule, 328 participants from Jiangmen and Jinan were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 4-6.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6426|NCT02796963|O1|Outcome|Immediate Intervention|"Based on the pre-determined randomization schedule, 383 participants from Guangzhou and Yantai were assigned to the first intervention group to receive a crowdsourced intervention in months 1-3.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6427|NCT02796963|O4|Outcome|Delayed Intervention 3|"Based on the pre-determined randomization schedule, 354 participants from Shenzhen and Jining were assigned to delayed intervention group 3 to receive a crowdsourced intervention in months 10-12.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6428|NCT02796963|O3|Outcome|Delayed Intervention 2|"Based on the pre-determined randomization schedule, 316 participants from Zhuhai and Qingdao were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 7-9.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6429|NCT02796963|O2|Outcome|Delayed Intervention 1|"Based on the pre-determined randomization schedule, 328 participants from Jiangmen and Jinan were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 4-6.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6430|NCT02796963|O1|Outcome|Immediate Intervention|"Based on the pre-determined randomization schedule, 383 participants from Guangzhou and Yantai were assigned to the first intervention group to receive a crowdsourced intervention in months 1-3.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6431|NCT02796963|O4|Outcome|Delayed Intervention 3|"Based on the pre-determined randomization schedule, 354 participants from Shenzhen and Jining were assigned to delayed intervention group 3 to receive a crowdsourced intervention in months 10-12.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6432|NCT02796963|O3|Outcome|Delayed Intervention 2|"Based on the pre-determined randomization schedule, 316 participants from Zhuhai and Qingdao were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 7-9.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6433|NCT02796963|O2|Outcome|Delayed Intervention 1|"Based on the pre-determined randomization schedule, 328 participants from Jiangmen and Jinan were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 4-6.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6434|NCT02796963|O1|Outcome|Immediate Intervention|"Based on the pre-determined randomization schedule, 383 participants from Guangzhou and Yantai were assigned to the first intervention group to receive a crowdsourced intervention in months 1-3.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6435|NCT02796963|O4|Outcome|Delayed Intervention 3|"Based on the pre-determined randomization schedule, 354 participants from Shenzhen and Jining were assigned to delayed intervention group 3 to receive a crowdsourced intervention in months 10-12.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6436|NCT02796963|O3|Outcome|Delayed Intervention 2|"Based on the pre-determined randomization schedule, 316 participants from Zhuhai and Qingdao were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 7-9.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6478|NCT02796651|O1|Outcome|Formoterol Fumarate 6 μg|Randomized participants received 2 puffs of Formoterol Fumarate 6 μg oral inhalation powder using Pressair® dry powder inhaler (DPI) in the morning and evening for 7 (±1) days
6509|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
6437|NCT02796963|O2|Outcome|Delayed Intervention 1|"Based on the pre-determined randomization schedule, 328 participants from Jiangmen and Jinan were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 4-6.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6438|NCT02796963|O1|Outcome|Immediate Intervention|"Based on the pre-determined randomization schedule, 383 participants from Guangzhou and Yantai were assigned to the first intervention group to receive a crowdsourced intervention in months 1-3.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6439|NCT02796963|O4|Outcome|Delayed Intervention 3|"Based on the pre-determined randomization schedule, 354 participants from Shenzhen and Jining were assigned to delayed intervention group 3 to receive a crowdsourced intervention in months 10-12.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6440|NCT02796963|O3|Outcome|Delayed Intervention 2|"Based on the pre-determined randomization schedule, 316 participants from Zhuhai and Qingdao were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 7-9.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6441|NCT02796963|O2|Outcome|Delayed Intervention 1|"Based on the pre-determined randomization schedule, 328 participants from Jiangmen and Jinan were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 4-6.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6442|NCT02796963|O1|Outcome|Immediate Intervention|"Based on the pre-determined randomization schedule, 383 participants from Guangzhou and Yantai were assigned to the first intervention group to receive a crowdsourced intervention in months 1-3.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6443|NCT02796963|O4|Outcome|Delayed Intervention 3|"Based on the pre-determined randomization schedule, 354 participants from Shenzhen and Jining were assigned to delayed intervention group 3 to receive a crowdsourced intervention in months 10-12.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6444|NCT02796963|O3|Outcome|Delayed Intervention 2|"Based on the pre-determined randomization schedule, 316 participants from Zhuhai and Qingdao were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 7-9.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6445|NCT02796963|O2|Outcome|Delayed Intervention 1|"Based on the pre-determined randomization schedule, 328 participants from Jiangmen and Jinan were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 4-6.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6446|NCT02796963|O1|Outcome|Immediate Intervention|"Based on the pre-determined randomization schedule, 383 participants from Guangzhou and Yantai were assigned to the first intervention group to receive a crowdsourced intervention in months 1-3.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6447|NCT02796963|O4|Outcome|Delayed Intervention 3|"Based on the pre-determined randomization schedule, 354 participants from Shenzhen and Jining were assigned to delayed intervention group 3 to receive a crowdsourced intervention in months 10-12.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6448|NCT02796963|O3|Outcome|Delayed Intervention 2|"Based on the pre-determined randomization schedule, 316 participants from Zhuhai and Qingdao were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 7-9.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6479|NCT02796651|O6|Outcome|Placebo (Lactose Monohydrate)|Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 6/12/24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
6510|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
6449|NCT02796963|O2|Outcome|Delayed Intervention 1|"Based on the pre-determined randomization schedule, 328 participants from Jiangmen and Jinan were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 4-6.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6450|NCT02796963|O1|Outcome|Immediate Intervention|"Based on the pre-determined randomization schedule, 383 participants from Guangzhou and Yantai were assigned to the first intervention group to receive a crowdsourced intervention in months 1-3.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6451|NCT02796963|O4|Outcome|Delayed Intervention 3|"Based on the pre-determined randomization schedule, 354 participants from Shenzhen and Jining were assigned to delayed intervention group 3 to receive a crowdsourced intervention in months 10-12.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6452|NCT02796963|O3|Outcome|Delayed Intervention 2|"Based on the pre-determined randomization schedule, 316 participants from Zhuhai and Qingdao were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 7-9.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6453|NCT02796963|O2|Outcome|Delayed Intervention 1|"Based on the pre-determined randomization schedule, 328 participants from Jiangmen and Jinan were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 4-6.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6454|NCT02796963|O1|Outcome|Immediate Intervention|"Based on the pre-determined randomization schedule, 383 participants from Guangzhou and Yantai were assigned to the first intervention group to receive a crowdsourced intervention in months 1-3.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6455|NCT02796963|O4|Outcome|Delayed Intervention 3|"Based on the pre-determined randomization schedule, 354 participants from Shenzhen and Jining were assigned to delayed intervention group 3 to receive a crowdsourced intervention in months 10-12.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6456|NCT02796963|O3|Outcome|Delayed Intervention 2|"Based on the pre-determined randomization schedule, 316 participants from Zhuhai and Qingdao were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 7-9.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6457|NCT02796963|O2|Outcome|Delayed Intervention 1|"Based on the pre-determined randomization schedule, 328 participants from Jiangmen and Jinan were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 4-6.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6458|NCT02796963|O1|Outcome|Immediate Intervention|"Based on the pre-determined randomization schedule, 383 participants from Guangzhou and Yantai were assigned to the first intervention group to receive a crowdsourced intervention in months 1-3.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6459|NCT02796963|O4|Outcome|Delayed Intervention 3|"Based on the pre-determined randomization schedule, 354 participants from Shenzhen and Jining were assigned to delayed intervention group 3 to receive a crowdsourced intervention in months 10-12.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6460|NCT02796963|O3|Outcome|Delayed Intervention 2|"Based on the pre-determined randomization schedule, 316 participants from Zhuhai and Qingdao were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 7-9.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6480|NCT02796651|O5|Outcome|Perforomist 40 μg|Randomized participants received single dose of 2 vials of Perforomist 20 μg oral nebulization solution via a jet nebulizer in the morning of Day 1 of assigned treatment period.
6481|NCT02796651|O4|Outcome|Perforomist 20 μg|Randomized participants received 1 vial of Perforomist 20 μg oral nebulization solution via a jet nebulizer in the morning and evening for 7 (±1) days
6461|NCT02796963|O2|Outcome|Delayed Intervention 1|"Based on the pre-determined randomization schedule, 328 participants from Jiangmen and Jinan were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 4-6.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6462|NCT02796963|O1|Outcome|Immediate Intervention|"Based on the pre-determined randomization schedule, 383 participants from Guangzhou and Yantai were assigned to the first intervention group to receive a crowdsourced intervention in months 1-3.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
6463|NCT02796963|E4|Reported Event|Delayed Intervention 3|"Based on the pre-determined randomization schedule, 354 participants from Shenzhen and Jining were assigned to delayed intervention group 3 to receive a crowdsourced intervention in months 10-12.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities.~No adverse outcome was reported."
6464|NCT02796963|E3|Reported Event|Delayed Intervention 2|"Based on the pre-determined randomization schedule, 316 participants from Zhuhai and Qingdao were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 7-9.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities.~No adverse outcome was reported."
6465|NCT02796963|E2|Reported Event|Delayed Intervention 1|"Based on the pre-determined randomization schedule, 328 participants from Jiangmen and Jinan were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 4-6.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities.~No adverse outcome was reported."
6466|NCT02796963|E1|Reported Event|Immediate Intervention|"Based on the pre-determined randomization schedule, 383 participants from Guangzhou and Yantai were assigned to the first intervention group to receive a crowdsourced intervention in months 1-3.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities.~No adverse outcome was reported."
6467|NCT02796651|B1|Baseline|Overall Study Total|"All patients were randomized in a treatment sequence containing 5 treatment periods. All patients received FF12 and Perforomist 20 mcg, 90% received FF6, FF24 and Perforomist 40 mcg, and only 30% received placebo. Treatment was double blind for FF in Pressair, and open label for Perforomist. If treatment was FF6, FF12, FF24 or placebo, patients received two identical Pressair DPI and were instructed to take 1 puff from each of the inhalers in the morning and in the evening for 7 days. If treatment was Perforomist 20 mcg, patients were instructed to take 1 vial in the morning and 1 vial in the evening for 7 days. Treatment with Perforomist 40 mcg was a single dose administration.~Note: 132 participants were randomized. But, one participant was excluded from the ITT analysis set as the participant did not have a post-baseline forced expiratory volume in 1 second (FEV1) measurement."
6468|NCT02796651|P1|Participant Flow|Total Participants|"All patients were randomized in a treatment sequence containing 5 treatment periods. All patients received FF12 and Perforomist 20 mcg, 90% received FF6, FF24 and Perforomist 40 mcg, and only 30% received placebo. Treatment was double blind for FF in Pressair, and open label for Perforomist. If treatment was FF6, FF12, FF24 or placebo, patients received two identical Pressair dry powder inhalers (DPI) and were instructed to take 1 puff from each of the inhalers in the morning and in the evening for 7 days. If treatment was Perforomist 20 mcg, patients were instructed to take 1 vial in the morning and 1 vial in the evening for 7 days. Treatment with Perforomist 40 mcg was a single dose administration.~Note: 132 participants were randomized. But, one participant was excluded from the ITT analysis set as the participant did not have a post-baseline forced expiratory volume in 1 second (FEV1) measurement."
6469|NCT02796651|O5|Outcome|Placebo (Lactose Monohydrate)|Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 6/12/24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
6470|NCT02796651|O4|Outcome|Perforomist 20 μg|Randomized participants received 1 vial of Perforomist 20 μg oral nebulization solution via a jet nebulizer in the morning and evening for 7 (±1) days
6471|NCT02796651|O3|Outcome|Formoterol Fumarate (FF) 24 μg|Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
6472|NCT02796651|O2|Outcome|Formoterol Fumarate (FF) 12 μg|Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 12 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
6473|NCT02796651|O1|Outcome|Formoterol Fumarate 6 μg|Randomized participants received 2 puffs of Formoterol Fumarate 6 μg oral inhalation powder using Pressair® dry powder inhaler (DPI) in the morning and evening for 7 (±1) days
6474|NCT02796651|O5|Outcome|Placebo (Lactose Monohydrate)|Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 6/12/24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
6475|NCT02796651|O4|Outcome|Perforomist 20 μg|Randomized participants received 1 vial of Perforomist 20 μg oral nebulization solution via a jet nebulizer in the morning and evening for 7 (±1) days
7030|NCT02780167|B4|Baseline|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
6482|NCT02796651|O3|Outcome|Formoterol Fumarate (FF) 24 μg|Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
6483|NCT02796651|O2|Outcome|Formoterol Fumarate (FF) 12 μg|Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 12 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
6484|NCT02796651|O1|Outcome|Formoterol Fumarate 6 μg|Randomized participants received 2 puffs of Formoterol Fumarate 6 μg oral inhalation powder using Pressair® dry powder inhaler (DPI) in the morning and evening for 7 (±1) days
6485|NCT02796651|O5|Outcome|Placebo (Lactose Monohydrate)|Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 6/12/24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
6486|NCT02796651|O4|Outcome|Perforomist 20 μg|Randomized participants received 1 vial of Perforomist 20 μg oral nebulization solution via a jet nebulizer in the morning and evening for 7 (±1) days
6487|NCT02796651|O3|Outcome|Formoterol Fumarate (FF) 24 μg|Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
6488|NCT02796651|O2|Outcome|Formoterol Fumarate (FF) 12 μg|Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 12 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
6489|NCT02796651|O1|Outcome|Formoterol Fumarate 6 μg|Randomized participants received 2 puffs of Formoterol Fumarate 6 μg oral inhalation powder using Pressair® dry powder inhaler (DPI) in the morning and evening for 7 (±1) days
6490|NCT02796651|E6|Reported Event|Placebo (Lactose Monohydrate)|Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 6/12/24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
6491|NCT02796651|E5|Reported Event|Perforomist 40 μg|Randomized participants received single dose of 2 vials of Perforomist 20 μg oral nebulization solution via a jet nebulizer in the morning of Day 1 of assigned treatment period.
6492|NCT02796651|E4|Reported Event|Perforomist 20 μg|Randomized participants received 1 vial of Perforomist 20 μg oral nebulization solution via a jet nebulizer in the morning and evening for 7 (±1) days
6493|NCT02796651|E3|Reported Event|Formoterol Fumarate (FF) 24 μg|Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
6494|NCT02796651|E2|Reported Event|Formoterol Fumarate (FF) 12 μg|Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 12 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
6495|NCT02796651|E1|Reported Event|Formoterol Fumarate 6 μg|Randomized participants received 2 puffs of Formoterol Fumarate 6 μg oral inhalation powder using Pressair® dry powder inhaler (DPI) in the morning and evening for 7 (±1) days
6496|NCT02796352|B1|Baseline|High Dose Bolus Interleukin-2 (HD IL2)|"High dose bolus interleukin-2 (HD IL2): Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle).~The planned treatment consists of 3 courses (6 cycles) of HD IL-2."
6497|NCT02796352|P1|Participant Flow|High Dose Bolus Interleukin-2 (HD IL2)|"High dose bolus interleukin-2 (HD IL2): Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle).~The planned treatment consists of 3 courses (6 cycles) of HD IL-2."
6498|NCT02796352|O1|Outcome|High Dose Bolus Interleukin-2 (HD IL2)|"High dose bolus interleukin-2 (HD IL2): Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle).~The planned treatment consists of 3 courses (6 cycles) of HD IL-2."
6499|NCT02796352|O1|Outcome|High Dose Bolus Interleukin-2 (HD IL2)|"High dose bolus interleukin-2 (HD IL2): Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle).~The planned treatment consists of 3 courses (6 cycles) of HD IL-2."
6500|NCT02796352|O1|Outcome|High Dose Bolus Interleukin-2 (HD IL2)|"High dose bolus interleukin-2 (HD IL2): Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle).~The planned treatment consists of 3 courses (6 cycles) of HD IL-2."
6501|NCT02796352|O1|Outcome|High Dose Bolus Interleukin-2 (HD IL2)|"High dose bolus interleukin-2 (HD IL2): Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle).~The planned treatment consists of 3 courses (6 cycles) of HD IL-2."
6502|NCT02796352|E1|Reported Event|High Dose Bolus Interleukin-2 (HD IL2)|"High dose bolus interleukin-2 (HD IL2): Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle).~The planned treatment consists of 3 courses (6 cycles) of HD IL-2."
6503|NCT02796092|B3|Baseline|Total|Total of all reporting groups
6504|NCT02796092|B2|Baseline|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
6505|NCT02796092|B1|Baseline|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
10912|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
6511|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
6512|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
6513|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
6514|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
6515|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
6516|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
6517|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
6518|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
6519|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
6520|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
6521|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
6522|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
6523|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
6524|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
6525|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
6526|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
6527|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
6528|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
6529|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
6530|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
6531|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
6532|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
6533|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
6534|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
6535|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
6536|NCT02796092|E2|Reported Event|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
6537|NCT02796092|E1|Reported Event|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
6538|NCT02794844|B1|Baseline|Genotype Guided PPI Dosing|"Genotype Guided PPI Dosing: PPI type and dosing will be recommended in real time based on patients' CYP2C19 genotype / metabolizer phenotype.~No other ARM will be studied."
6539|NCT02794844|P1|Participant Flow|Genotype Guided PPI Dosing|"Genotype Guided PPI Dosing: PPI type and dosing will be recommended in real time based on patients' CYP2C19 genotype / metabolizer phenotype.~No other ARM will be studied."
6540|NCT02794844|O1|Outcome|Genotype Guided PPI Dosing|"Genotype Guided PPI Dosing: PI type and dosing will be recommended in real time based on patients' CYP2C19 genotype / metabolizer phenotype.~No other ARM will be studied.~Genotype Guided PPI Dosing: Dosing of PPIs such as Prevacid and Nexium will be recommended based on CYP2C19 genotype information."
6541|NCT02794844|O1|Outcome|Genotype Guided PPI Dosing|"Genotype Guided PPI Dosing: PI type and dosing will be recommended in real time based on patients' CYP2C19 genotype / metabolizer phenotype.~No other ARM will be studied.~Genotype Guided PPI Dosing: Dosing of PPIs such as Prevacid and Nexium will be recommended based on CYP2C19 genotype information."
6542|NCT02794844|O1|Outcome|Genotype Guided PPI Dosing|"Genotype Guided PPI Dosing: PI type and dosing will be recommended in real time based on patients' CYP2C19 genotype / metabolizer phenotype.~No other ARM will be studied.~Genotype Guided PPI Dosing: Dosing of PPIs such as Prevacid and Nexium will be recommended based on CYP2C19 genotype information."
6543|NCT02794844|O1|Outcome|Genotype Guided PPI Dosing|"Genotype Guided PPI Dosing: PI type and dosing will be recommended in real time based on patients' CYP2C19 genotype / metabolizer phenotype.~No other ARM will be studied.~Genotype Guided PPI Dosing: Dosing of PPIs such as Prevacid and Nexium will be recommended based on CYP2C19 genotype information."
6676|NCT02792062|O3|Outcome|TAK-385 40 mg After Breakfast|TAK-385 40 mg, tablets, orally, after 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
11242|NCT02675907|O2|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
6544|NCT02794844|O1|Outcome|Genotype Guided PPI Dosing|"Genotype Guided PPI Dosing: PI type and dosing will be recommended in real time based on patients' CYP2C19 genotype / metabolizer phenotype.~No other ARM will be studied.~Genotype Guided PPI Dosing: Dosing of PPIs such as Prevacid and Nexium will be recommended based on CYP2C19 genotype information."
6545|NCT02794844|O1|Outcome|Genotype Guided PPI Dosing|"Genotype Guided PPI Dosing: PI type and dosing will be recommended in real time based on patients' CYP2C19 genotype / metabolizer phenotype.~No other ARM will be studied.~Genotype Guided PPI Dosing: Dosing of PPIs such as Prevacid and Nexium will be recommended based on CYP2C19 genotype information."
6546|NCT02794844|E1|Reported Event|Genotype Guided PPI Dosing|"Genotype Guided PPI Dosing: PI type and dosing will be recommended in real time based on patients' CYP2C19 genotype / metabolizer phenotype.~No other ARM will be studied.~Genotype Guided PPI Dosing: Dosing of PPIs such as Prevacid and Nexium will be recommended based on CYP2C19 genotype information."
6547|NCT02794480|B3|Baseline|Total|Total of all reporting groups
6548|NCT02794480|B2|Baseline|Sub-Study 2 (Seq 1: Ellipta/AZ MDI; Seq 2: AZ MDI/Ellipta)|Par were randomized to treatment sequence 1 or 2. In treatment sequence 1, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo AZ MDI at Visit 2 for treatment period 2. In treatment sequence 2, the par were dispensed Placebo AZ MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. AZ MDI was a placebo inhaler containing liquid aerosol. ELLIPTA DPI was taken as one inhalation, once daily and AZ MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
6549|NCT02794480|B1|Baseline|Sub-Study 1 (Seq 3: Ellipta/GSK MDI; Seq 4: GSK MDI/Ellipta)|Par were randomized to treatment sequence 3 or 4. In treatment sequence 3, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo GSK MDI at Visit 2 for treatment period 2. In treatment sequence 4, the par were dispensed Placebo GSK MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. GSK MDI contained propellant (1,1,1,2-Tetrafluoroethane). ELLIPTA DPI was taken as one inhalation, once daily and GSK MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
6550|NCT02794480|P4|Participant Flow|Sub-Study 2 (Seq 2: AZ MDI/Ellipta)|Par were randomized to treatment sequence 1 or 2. In treatment sequence 1, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo AZ MDI at Visit 2 for treatment period 2. In treatment sequence 2, the par were dispensed Placebo AZ MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. AZ MDI was a placebo inhaler containing liquid aerosol. ELLIPTA DPI was taken as one inhalation, once daily and AZ MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
6551|NCT02794480|P3|Participant Flow|Sub-Study 2 (Seq 1: Ellipta/AZ MDI)|Par were randomized to treatment sequence 1 or 2. In treatment sequence 1, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo AZ MDI at Visit 2 for treatment period 2. In treatment sequence 2, the par were dispensed Placebo AZ MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. AZ MDI was a placebo inhaler containing liquid aerosol. ELLIPTA DPI was taken as one inhalation, once daily and AZ MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
6552|NCT02794480|P2|Participant Flow|Sub-Study 1 (Seq 4: GSK MDI/Ellipta)|Par were randomized to treatment sequence 3 or 4. In treatment sequence 3, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo GSK MDI at Visit 2 for treatment period 2. In treatment sequence 4, the par were dispensed Placebo GSK MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. GSK MDI contained propellant (1,1,1,2-Tetrafluoroethane). ELLIPTA DPI was taken as one inhalation, once daily and GSK MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
6553|NCT02794480|P1|Participant Flow|Sub-Study 1 (Seq 3: Ellipta/GSK MDI)|Par were randomized to treatment sequence 3 or 4. In treatment sequence 3, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo GSK MDI at Visit 2 for treatment period 2. In treatment sequence 4, the par were dispensed Placebo GSK MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. GSK MDI contained propellant (1,1,1,2-Tetrafluoroethane). ELLIPTA DPI was taken as one inhalation, once daily and GSK MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
6554|NCT02794480|O2|Outcome|Sub-Study 2|Par were randomized to treatment sequence 1 or 2. In treatment sequence 1, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo AZ MDI at Visit 2 for treatment period 2. In treatment sequence 2, the par were dispensed Placebo AZ MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. AZ MDI was a placebo inhaler containing liquid aerosol. ELLIPTA DPI was taken as one inhalation, once daily and AZ MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
6677|NCT02792062|O2|Outcome|TAK-385 40 mg Before Breakfast|TAK-385 40 mg, tablets, orally, before 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
20035|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
6555|NCT02794480|O1|Outcome|Sub-Study 1|Par were randomized to treatment sequence 3 or 4. In treatment sequence 3, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo GSK MDI at Visit 2 for treatment period 2. In treatment sequence 4, the par were dispensed Placebo GSK MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. GSK MDI contained propellant (1,1,1,2-Tetrafluoroethane). ELLIPTA DPI was taken as one inhalation, once daily and GSK MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
6556|NCT02794480|O2|Outcome|Sub-Study 2|Par were randomized to treatment sequence 1 or 2. In treatment sequence 1, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo AZ MDI at Visit 2 for treatment period 2. In treatment sequence 2, the par were dispensed Placebo AZ MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. AZ MDI was a placebo inhaler containing liquid aerosol. ELLIPTA DPI was taken as one inhalation, once daily and AZ MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
6557|NCT02794480|O1|Outcome|Sub-Study 1|Par were randomized to treatment sequence 3 or 4. In treatment sequence 3, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo GSK MDI at Visit 2 for treatment period 2. In treatment sequence 4, the par were dispensed Placebo GSK MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. GSK MDI contained propellant (1,1,1,2-Tetrafluoroethane). ELLIPTA DPI was taken as one inhalation, once daily and GSK MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
6558|NCT02794480|O2|Outcome|Sub-Study 2|Par were randomized to treatment sequence 1 or 2. In treatment sequence 1, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo AZ MDI at Visit 2 for treatment period 2. In treatment sequence 2, the par were dispensed Placebo AZ MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. AZ MDI was a placebo inhaler containing liquid aerosol. ELLIPTA DPI was taken as one inhalation, once daily and AZ MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
6559|NCT02794480|O1|Outcome|Sub-Study 1|Par were randomized to treatment sequence 3 or 4. In treatment sequence 3, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo GSK MDI at Visit 2 for treatment period 2. In treatment sequence 4, the par were dispensed Placebo GSK MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. GSK MDI contained propellant (1,1,1,2-Tetrafluoroethane). ELLIPTA DPI was taken as one inhalation, once daily and GSK MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
6560|NCT02794480|O2|Outcome|Sub-Study 2|Par were randomized to treatment sequence 1 or 2. In treatment sequence 1, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo AZ MDI at Visit 2 for treatment period 2. In treatment sequence 2, the par were dispensed Placebo AZ MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. AZ MDI was a placebo inhaler containing liquid aerosol. ELLIPTA DPI was taken as one inhalation, once daily and AZ MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
6561|NCT02794480|O1|Outcome|Sub-Study 1|Par were randomized to treatment sequence 3 or 4. In treatment sequence 3, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo GSK MDI at Visit 2 for treatment period 2. In treatment sequence 4, the par were dispensed Placebo GSK MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. GSK MDI contained propellant (1,1,1,2-Tetrafluoroethane). ELLIPTA DPI was taken as one inhalation, once daily and GSK MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
6562|NCT02794480|O2|Outcome|Sub-Study 2|Par were randomized to treatment sequence 1 or 2. In treatment sequence 1, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo AZ MDI at Visit 2 for treatment period 2. In treatment sequence 2, the par were dispensed Placebo AZ MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. AZ MDI was a placebo inhaler containing liquid aerosol. ELLIPTA DPI was taken as one inhalation, once daily and AZ MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
6563|NCT02794480|O1|Outcome|Sub-Study 1|Par were randomized to treatment sequence 3 or 4. In treatment sequence 3, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo GSK MDI at Visit 2 for treatment period 2. In treatment sequence 4, the par were dispensed Placebo GSK MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. GSK MDI contained propellant (1,1,1,2-Tetrafluoroethane). ELLIPTA DPI was taken as one inhalation, once daily and GSK MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
6564|NCT02794480|O2|Outcome|Sub-Study 2|Par were randomized to treatment sequence 1 or 2. In treatment sequence 1, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo AZ MDI at Visit 2 for treatment period 2. In treatment sequence 2, the par were dispensed Placebo AZ MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. AZ MDI was a placebo inhaler containing liquid aerosol. ELLIPTA DPI was taken as one inhalation, once daily and AZ MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
6565|NCT02794480|O1|Outcome|Sub-Study 1|Par were randomized to treatment sequence 3 or 4. In treatment sequence 3, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo GSK MDI at Visit 2 for treatment period 2. In treatment sequence 4, the par were dispensed Placebo GSK MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. GSK MDI contained propellant (1,1,1,2-Tetrafluoroethane). ELLIPTA DPI was taken as one inhalation, once daily and GSK MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
6566|NCT02794480|E4|Reported Event|Sub-Study 2 - AZ MDI (Sequence 1,2)|Par were randomized to treatment sequence 1 or 2. In treatment sequence 1, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo AZ MDI at Visit 2 for treatment period 2. In treatment sequence 2, the par were dispensed Placebo AZ MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. AZ MDI was a placebo inhaler containing liquid aerosol. ELLIPTA DPI was taken as one inhalation, once daily and AZ MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
6567|NCT02794480|E3|Reported Event|Sub-Study 2 - Ellipta (Sequence 1,2)|Par were randomized to treatment sequence 1 or 2. In treatment sequence 1, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo AZ MDI at Visit 2 for treatment period 2. In treatment sequence 2, the par were dispensed Placebo AZ MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. AZ MDI was a placebo inhaler containing liquid aerosol. ELLIPTA DPI was taken as one inhalation, once daily and AZ MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
6568|NCT02794480|E2|Reported Event|Sub-Study 1 - GSK MDI (Sequence 3,4)|Par were randomized to treatment sequence 3 or 4. In treatment sequence 3, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo GSK MDI at Visit 2 for treatment period 2. In treatment sequence 4, the par were dispensed Placebo GSK MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. GSK MDI contained propellant (1,1,1,2-Tetrafluoroethane). ELLIPTA DPI was taken as one inhalation, once daily and GSK MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
6569|NCT02794480|E1|Reported Event|Sub-Study 1 - Ellipta (Sequence 3,4)|Par were randomized to treatment sequence 3 or 4. In treatment sequence 3, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo GSK MDI at Visit 2 for treatment period 2. In treatment sequence 4, the par were dispensed Placebo GSK MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. GSK MDI contained propellant (1,1,1,2-Tetrafluoroethane). ELLIPTA DPI was taken as one inhalation, once daily and GSK MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
6570|NCT02793947|B3|Baseline|Total|Total of all reporting groups
6571|NCT02793947|B2|Baseline|Control (no Injection)|Femur fracture fixation/instrumentation will be completed per the standard of care. No peri-incisional injection will be completed.
6572|NCT02793947|B1|Baseline|Peri-incisional Injection|A 100 cc multimodal analgesic cocktail will be injected into the superficial and deep peri-incisional tissues after the completion of femur fracture fixation/instrumentation while the patient remains under general anesthesia and prior to wound closure. This cocktail includes 400 mg of 0.75% ropivacaine (53.33 mL), 0.6 mg of 1 mg/mL epinephrine (0.6 mL), 5 mg of 0.5 mg/mL morphine sulfate (10 mL), and 36.07 mL 0.9% sodium chloride solution. All infiltrations will be completed with a blunt trochar to minimize the risk of intravascular injection.
6573|NCT02793947|P2|Participant Flow|Control (no Injection)|Femur fracture fixation/instrumentation will be completed per the standard of care. No peri-incisional injection will be completed.
6574|NCT02793947|P1|Participant Flow|Peri-incisional Injection|A 100 cc multimodal analgesic cocktail will be injected into the superficial and deep peri-incisional tissues after the completion of femur fracture fixation/instrumentation while the patient remains under general anesthesia and prior to wound closure. This cocktail includes 400 mg of 0.75% ropivacaine (53.33 mL), 0.6 mg of 1 mg/mL epinephrine (0.6 mL), 5 mg of 0.5 mg/mL morphine sulfate (10 mL), and 36.07 mL 0.9% sodium chloride solution. All infiltrations will be completed with a blunt trochar to minimize the risk of intravascular injection.
6575|NCT02793947|O2|Outcome|Control (no Injection)|Femur fracture fixation/instrumentation will be completed per the standard of care. No peri-incisional injection will be completed.
6596|NCT02793154|O2|Outcome|Part B: Albiglutide SC Injection|Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
7031|NCT02780167|B3|Baseline|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
6576|NCT02793947|O1|Outcome|Peri-incisional Injection|A 100 cc multimodal analgesic cocktail will be injected into the superficial and deep peri-incisional tissues after the completion of femur fracture fixation/instrumentation while the patient remains under general anesthesia and prior to wound closure. This cocktail includes 400 mg of 0.75% ropivacaine (53.33 mL), 0.6 mg of 1 mg/mL epinephrine (0.6 mL), 5 mg of 0.5 mg/mL morphine sulfate (10 mL), and 36.07 mL 0.9% sodium chloride solution. All infiltrations will be completed with a blunt trochar to minimize the risk of intravascular injection.
6577|NCT02793947|O2|Outcome|Control (no Injection)|Femur fracture fixation/instrumentation will be completed per the standard of care. No peri-incisional injection will be completed.
6578|NCT02793947|O1|Outcome|Peri-incisional Injection|A 100 cc multimodal analgesic cocktail will be injected into the superficial and deep peri-incisional tissues after the completion of femur fracture fixation/instrumentation while the patient remains under general anesthesia and prior to wound closure. This cocktail includes 400 mg of 0.75% ropivacaine (53.33 mL), 0.6 mg of 1 mg/mL epinephrine (0.6 mL), 5 mg of 0.5 mg/mL morphine sulfate (10 mL), and 36.07 mL 0.9% sodium chloride solution. All infiltrations will be completed with a blunt trochar to minimize the risk of intravascular injection.
6579|NCT02793947|O2|Outcome|Control (no Injection)|Femur fracture fixation/instrumentation will be completed per the standard of care. No peri-incisional injection will be completed.
6580|NCT02793947|O1|Outcome|Peri-incisional Injection|A 100 cc multimodal analgesic cocktail will be injected into the superficial and deep peri-incisional tissues after the completion of femur fracture fixation/instrumentation while the patient remains under general anesthesia and prior to wound closure. This cocktail includes 400 mg of 0.75% ropivacaine (53.33 mL), 0.6 mg of 1 mg/mL epinephrine (0.6 mL), 5 mg of 0.5 mg/mL morphine sulfate (10 mL), and 36.07 mL 0.9% sodium chloride solution. All infiltrations will be completed with a blunt trochar to minimize the risk of intravascular injection.
6581|NCT02793947|E2|Reported Event|Control (no Injection)|Femur fracture fixation/instrumentation will be completed per the standard of care. No peri-incisional injection will be completed.
6582|NCT02793947|E1|Reported Event|Peri-incisional Injection|A 100 cc multimodal analgesic cocktail will be injected into the superficial and deep peri-incisional tissues after the completion of femur fracture fixation/instrumentation while the patient remains under general anesthesia and prior to wound closure. The cocktail includes 400 mg of 0.75% ropivacaine (53.33 mL), 0.6 mg of 1 mg/mL epinephrine (0.6 mL), 5 mg of 0.5 mg/mL morphine sulfate (10 mL), and 36.07 mL 0.9% sodium chloride solution. All infiltrations will be completed with a blunt trochar to minimize the risk of intravascular injection.
6583|NCT02793154|B4|Baseline|Total|Total of all reporting groups
6584|NCT02793154|B3|Baseline|Part B: Albiglutide SC Injection|Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
6585|NCT02793154|B2|Baseline|Part B: Exenatide SC Injection|Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.
6586|NCT02793154|B1|Baseline|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6587|NCT02793154|P3|Participant Flow|Part B: Albiglutide SC Injection|Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
6588|NCT02793154|P2|Participant Flow|Part B: Exenatide SC Injection|Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.
6589|NCT02793154|P1|Participant Flow|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6590|NCT02793154|O2|Outcome|Part B: Albiglutide SC Injection|Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
6591|NCT02793154|O1|Outcome|Part B: Exenatide SC Injection|Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.
6592|NCT02793154|O2|Outcome|Part B: Albiglutide SC Injection|Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
6593|NCT02793154|O1|Outcome|Part B: Exenatide SC Injection|Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.
6594|NCT02793154|O2|Outcome|Part B: Albiglutide SC Injection|Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
6595|NCT02793154|O1|Outcome|Part B: Exenatide SC Injection|Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.
6597|NCT02793154|O1|Outcome|Part B: Exenatide SC Injection|Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.
6598|NCT02793154|O2|Outcome|Part B: Albiglutide SC Injection|Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
6599|NCT02793154|O1|Outcome|Part B: Exenatide SC Injection|Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.
6600|NCT02793154|O2|Outcome|Part B: Albiglutide SC Injection|Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
6601|NCT02793154|O1|Outcome|Part B: Exenatide SC Injection|Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.
6602|NCT02793154|O2|Outcome|Part B: Albiglutide SC Injection|Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
6603|NCT02793154|O1|Outcome|Part B: Exenatide SC Injection|Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.
6604|NCT02793154|O2|Outcome|Part B: Albiglutide SC Injection|Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
6605|NCT02793154|O1|Outcome|Part B: Exenatide SC Injection|Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.
6606|NCT02793154|O2|Outcome|Part B: Albiglutide SC Injection|Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
6607|NCT02793154|O1|Outcome|Part B: Exenatide SC Injection|Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.
6608|NCT02793154|O2|Outcome|Part B: Albiglutide SC Injection|Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
6609|NCT02793154|O1|Outcome|Part B: Exenatide SC Injection|Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.
6610|NCT02793154|O2|Outcome|Part B: Albiglutide SC Injection|Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
6611|NCT02793154|O1|Outcome|Part B: Exenatide SC Injection|Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.
6612|NCT02793154|O2|Outcome|Part B: Albiglutide SC Injection|Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
6613|NCT02793154|O1|Outcome|Part B: Exenatide SC Injection|Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.
6614|NCT02793154|O2|Outcome|Part B: Albiglutide SC Injection|Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
6615|NCT02793154|O1|Outcome|Part B: Exenatide SC Injection|Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.
6616|NCT02793154|O2|Outcome|Part B: Albiglutide SC Injection|Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
7682|NCT02756624|O2|Outcome|AC-170 Vehicle|"1 drop in each eye 3 times daily for up to 6 weeks~AC-170 Vehicle"
6617|NCT02793154|O1|Outcome|Part B: Exenatide SC Injection|Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.
6618|NCT02793154|O2|Outcome|Part B: Albiglutide SC Injection|Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
6619|NCT02793154|O1|Outcome|Part B: Exenatide SC Injection|Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.
6620|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6621|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6622|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6623|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6624|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6625|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6626|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6627|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6628|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6629|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6630|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6631|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6632|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6633|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6634|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6635|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6636|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6637|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
7032|NCT02780167|B2|Baseline|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
6638|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6639|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6640|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6641|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6642|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6643|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6644|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6645|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6646|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6647|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6648|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6649|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6650|NCT02793154|O1|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6651|NCT02793154|E3|Reported Event|Part B: Albiglutide SC Injection|Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
6652|NCT02793154|E2|Reported Event|Part B: Exenatide SC Injection|Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.
6653|NCT02793154|E1|Reported Event|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
6654|NCT02792062|B7|Baseline|Total|Total of all reporting groups
6655|NCT02792062|B6|Baseline|TAK-385: After Breakfast+ Before Breakfast + Fasted|TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 3.
6656|NCT02792062|B5|Baseline|TAK-385: Before Breakfast+ Fasted + After Breakfast|TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 3.
6657|NCT02792062|B4|Baseline|TAK-385: Fasted+ After Breakfast + Before Breakfast|TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 3.
6658|NCT02792062|B3|Baseline|TAK-385: After Breakfast+ Fasted + Before Breakfast|TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 3.
6659|NCT02792062|B2|Baseline|TAK-385: Before Breakfast+ After Breakfast + Fasted|TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 3.
6660|NCT02792062|B1|Baseline|TAK-385: Fasted+ Before Breakfast + After Breakfast|TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hour (hr) overnight fast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 3.
6661|NCT02792062|P6|Participant Flow|TAK-385: After Breakfast+ Before Breakfast + Fasted|TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 3.
6662|NCT02792062|P5|Participant Flow|TAK-385: Before Breakfast+ Fasted + After Breakfast|TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 3.
6663|NCT02792062|P4|Participant Flow|TAK-385: Fasted+ After Breakfast + Before Breakfast|TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 3.
6664|NCT02792062|P3|Participant Flow|TAK-385: After Breakfast+ Fasted + Before Breakfast|TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 3.
6665|NCT02792062|P2|Participant Flow|TAK-385: Before Breakfast+ After Breakfast + Fasted|TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 3.
6666|NCT02792062|P1|Participant Flow|TAK-385: Fasted+ Before Breakfast + After Breakfast|TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hour (hr) overnight fast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 3.
6667|NCT02792062|O3|Outcome|TAK-385 40 mg After Breakfast|TAK-385 40 mg, tablets, orally, after 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
6668|NCT02792062|O2|Outcome|TAK-385 40 mg Before Breakfast|TAK-385 40 mg, tablets, orally, before 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
6669|NCT02792062|O1|Outcome|TAK-385 40 mg Fasted|TAK-385 40 mg, tablets, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast, once on Day 1 of either intervention period 1, 2, or 3.
6670|NCT02792062|O3|Outcome|TAK-385 40 mg After Breakfast|TAK-385 40 mg, tablets, orally, after 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
6671|NCT02792062|O2|Outcome|TAK-385 40 mg Before Breakfast|TAK-385 40 mg, tablets, orally, before 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
6672|NCT02792062|O1|Outcome|TAK-385 40 mg Fasted|TAK-385 40 mg, tablets, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast, once on Day 1 of either intervention period 1, 2, or 3.
6673|NCT02792062|O3|Outcome|TAK-385 40 mg After Breakfast|TAK-385 40 mg, tablets, orally, after 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
6674|NCT02792062|O2|Outcome|TAK-385 40 mg Before Breakfast|TAK-385 40 mg, tablets, orally, before 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
6675|NCT02792062|O1|Outcome|TAK-385 40 mg Fasted|TAK-385 40 mg, tablets, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast, once on Day 1 of either intervention period 1, 2, or 3.
7033|NCT02780167|B1|Baseline|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
6678|NCT02792062|O1|Outcome|TAK-385 40 mg Fasted|TAK-385 40 mg, tablets, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast, once on Day 1 of either intervention period 1, 2, or 3.
6679|NCT02792062|O3|Outcome|TAK-385 40 mg After Breakfast|TAK-385 40 mg, tablets, orally, after 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
6680|NCT02792062|O2|Outcome|TAK-385 40 mg Before Breakfast|TAK-385 40 mg, tablets, orally, before 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
6681|NCT02792062|O1|Outcome|TAK-385 40 mg Fasted|TAK-385 40 mg, tablets, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast, once on Day 1 of either intervention period 1, 2, or 3.
6682|NCT02792062|O3|Outcome|TAK-385 40 mg After Breakfast|TAK-385 40 mg, tablets, orally, after 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
6683|NCT02792062|O2|Outcome|TAK-385 40 mg Before Breakfast|TAK-385 40 mg, tablets, orally, before 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
6684|NCT02792062|O1|Outcome|TAK-385 40 mg Fasted|TAK-385 40 mg, tablets, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast, once on Day 1 of either intervention period 1, 2, or 3.
6685|NCT02792062|O3|Outcome|TAK-385 40 mg After Breakfast|TAK-385 40 mg, tablets, orally, after 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
6686|NCT02792062|O2|Outcome|TAK-385 40 mg Before Breakfast|TAK-385 40 mg, tablets, orally, before 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
6687|NCT02792062|O1|Outcome|TAK-385 40 mg Fasted|TAK-385 40 mg, tablets, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast, once on Day 1 of either intervention period 1, 2, or 3.
6688|NCT02792062|O3|Outcome|TAK-385 40 mg After Breakfast|TAK-385 40 mg, tablets, orally, after 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
6689|NCT02792062|O2|Outcome|TAK-385 40 mg Before Breakfast|TAK-385 40 mg, tablets, orally, before 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
6690|NCT02792062|O1|Outcome|TAK-385 40 mg Fasted|TAK-385 40 mg, tablets, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast, once on Day 1 of either intervention period 1, 2, or 3.
6691|NCT02792062|O3|Outcome|TAK-385 40 mg After Breakfast|TAK-385 40 mg, tablets, orally, after 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
6692|NCT02792062|O2|Outcome|TAK-385 40 mg Before Breakfast|TAK-385 40 mg, tablets, orally, before 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
6693|NCT02792062|O1|Outcome|TAK-385 40 mg Fasted|TAK-385 40 mg, tablets, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast, once on Day 1 of either intervention period 1, 2, or 3.
6694|NCT02792062|E3|Reported Event|TAK-385 40 mg After Breakfast|TAK-385 40 mg, tablets, orally, after 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
6695|NCT02792062|E2|Reported Event|TAK-385 40 mg Before Breakfast|TAK-385 40 mg, tablets, orally, before 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
6696|NCT02792062|E1|Reported Event|TAK-385 40 mg Fasted|TAK-385 40 mg, tablets, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast, once on Day 1 of either intervention period 1, 2, or 3.
6697|NCT02792049|B3|Baseline|Total|Total of all reporting groups
6698|NCT02792049|B2|Baseline|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
6699|NCT02792049|B1|Baseline|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
6700|NCT02792049|P2|Participant Flow|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
6701|NCT02792049|P1|Participant Flow|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
6702|NCT02792049|O2|Outcome|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
6703|NCT02792049|O1|Outcome|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
6704|NCT02792049|O2|Outcome|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
6705|NCT02792049|O1|Outcome|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
7034|NCT02780167|P5|Participant Flow|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
6706|NCT02792049|O2|Outcome|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
6707|NCT02792049|O1|Outcome|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
6708|NCT02792049|O2|Outcome|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
6709|NCT02792049|O1|Outcome|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
6710|NCT02792049|O2|Outcome|Conventional Ambu Spur II Bag Valve Mask|A health volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).
6711|NCT02792049|O1|Outcome|Modified Ambu Spur II Bag Valve Mask|A health volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).
6712|NCT02792049|E2|Reported Event|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
6713|NCT02792049|E1|Reported Event|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
6714|NCT02791659|B3|Baseline|Total|Total of all reporting groups
6715|NCT02791659|B2|Baseline|Prone|"In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.~Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
6716|NCT02791659|B1|Baseline|Left Lateral Decubitus|"In this group, the position will be assigned to Left lateral decubitus during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.~Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
6717|NCT02791659|P2|Participant Flow|Prone|"In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.~Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
6718|NCT02791659|P1|Participant Flow|Left Lateral Decubitus|"In this group, the position will be assigned to Left lateral decubitus during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.~Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
6719|NCT02791659|O2|Outcome|Prone|"In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.~Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
6720|NCT02791659|O1|Outcome|Left Lateral Decubitus|"In this group, the position will be assigned to Left lateral decubitus during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.~Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
6721|NCT02791659|E2|Reported Event|Prone|"In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.~Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
6722|NCT02791659|E1|Reported Event|Left Lateral Decubitus|"In this group, the position will be assigned to Left lateral decubitus during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.~Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
6723|NCT02791269|B3|Baseline|Total|Total of all reporting groups
6724|NCT02791269|B2|Baseline|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
6725|NCT02791269|B1|Baseline|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
6726|NCT02791269|P2|Participant Flow|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
6727|NCT02791269|P1|Participant Flow|HBeAg Negative Participants|Hepatitis B e antigen (HBeAg) negative participants received peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (SC) injection once weekly (QW) for 48 weeks followed by a 24 weeks treatment-free follow-up period.
6728|NCT02791269|O1|Outcome|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
7683|NCT02756624|O1|Outcome|AC-170 0.24%|"1 drop in each eye 3 times daily for up to 6 weeks~AC-170 0.24%"
6729|NCT02791269|O2|Outcome|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
6730|NCT02791269|O1|Outcome|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
6731|NCT02791269|O2|Outcome|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
6732|NCT02791269|O1|Outcome|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
6733|NCT02791269|O2|Outcome|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
6734|NCT02791269|O1|Outcome|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
6735|NCT02791269|O2|Outcome|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
6736|NCT02791269|O1|Outcome|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period
6737|NCT02791269|O1|Outcome|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
6738|NCT02791269|E2|Reported Event|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
6739|NCT02791269|E1|Reported Event|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
6740|NCT02790281|B1|Baseline|Overall Study|Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn’s disease and C-reactive protein (CRP) >5 mg/L.
6741|NCT02790281|P1|Participant Flow|Overall Study|Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn’s disease and C-reactive protein (CRP) >5 mg/L.
6742|NCT02790281|O1|Outcome|Overall Study|Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn’s disease and C-reactive protein (CRP) >5 mg/L.
6743|NCT02790281|O1|Outcome|Overall Study|Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn’s disease and C-reactive protein (CRP) >5 mg/L.
6744|NCT02790281|O1|Outcome|Overall Study|Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn’s disease and C-reactive protein (CRP) >5 mg/L.
6745|NCT02790281|E1|Reported Event|Overall Study|Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn’s disease and C-reactive protein (CRP) >5 mg/L.
6746|NCT02788357|B3|Baseline|Total|Total of all reporting groups
6747|NCT02788357|B2|Baseline|Placebo With Motor Training|"Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays~Placebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
6748|NCT02788357|B1|Baseline|Atomoxetine With Motor Training|"40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays~Atomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
6749|NCT02788357|P2|Participant Flow|Placebo With Motor Training|"Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays~Placebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
6750|NCT02788357|P1|Participant Flow|Atomoxetine With Motor Training|"40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays~Atomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
6751|NCT02788357|O2|Outcome|Placebo With Motor Training|"Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays~Placebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
6752|NCT02788357|O1|Outcome|Atomoxetine With Motor Training|"40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays~Atomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
6753|NCT02788357|O2|Outcome|Placebo With Motor Training|"Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays~Placebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
6754|NCT02788357|O1|Outcome|Atomoxetine With Motor Training|"40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays~Atomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
6755|NCT02788357|O2|Outcome|Placebo With Motor Training|"Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays~Placebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
6756|NCT02788357|O1|Outcome|Atomoxetine With Motor Training|"40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays~Atomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
6757|NCT02788357|O2|Outcome|Placebo With Motor Training|"Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays~Placebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
6758|NCT02788357|O1|Outcome|Atomoxetine With Motor Training|"40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays~Atomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
6759|NCT02788357|E2|Reported Event|Placebo With Motor Training|"Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays~Placebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
6760|NCT02788357|E1|Reported Event|Atomoxetine With Motor Training|"40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays~Atomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
6761|NCT02788097|B3|Baseline|Total|Total of all reporting groups
6762|NCT02788097|B2|Baseline|Progesterone + 5|"the transfer of day 5 blastocysts on the 6th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers"
6763|NCT02788097|B1|Baseline|Progesterone + 4|"the transfer of day 5 blastocyst on the 5th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers"
6764|NCT02788097|P2|Participant Flow|Progesterone + 5|"the transfer of day 5 blastocysts on the 6th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers~69 patients randomized to this group"
6765|NCT02788097|P1|Participant Flow|Progesterone + 4|"the transfer of day 5 blastocyst on the 5th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers~61 patients randomized to this group"
6766|NCT02788097|O2|Outcome|Progesterone + 5|"the transfer of day 5 blastocysts on the 6th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers~69 patients randomized to this group"
6767|NCT02788097|O1|Outcome|Progesterone + 4|"the transfer of day 5 blastocyst on the 5th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers~61 patients randomized to this group"
6768|NCT02788097|E2|Reported Event|Progesterone + 5|"the transfer of day 5 blastocysts on the 6th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers~69 patients randomized to this group"
6769|NCT02788097|E1|Reported Event|Progesterone + 4|"the transfer of day 5 blastocyst on the 5th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers~61 patients randomized to this group"
6770|NCT02787564|B3|Baseline|Total|Total of all reporting groups
6771|NCT02787564|B2|Baseline|Control Goup|Control Group: A total of four 24h-food-recall questionnaires will be administered to men (>30 years, living alone) at risk of poverty over a period of approximately 8 weeks to assess their usual food intake. At baseline and at the end a 4-week period, a FFQ and a questionnaire on consumed fruit and vegetable amounts and variety will be administered.
6772|NCT02787564|B1|Baseline|Free Fruit and Vegetables|"A total of four 24h-food-recall questionnaires will be administered to men (>30 years, living alone) at risk of poverty over a period of approximately 8 weeks. After baseline assessment of food intake patterns, the intervention will consist of providing free fruits and vegetables of their choice for a period of four weeks which will be provided fresh each week. At baseline and at the end of the 8-week period, a FFQ and a questionnaire on consumed fruit and vegetable amounts and variety will be administered.~Intervention Group: The intervention consists of providing free fruits and vegetables of the participants' liking for a period of 4 weeks. Each week, a total of 2 portions of either fruits and/or vegetables per day will be provided."
6773|NCT02787564|P2|Participant Flow|Control Goup|Control Group: A total of four 24h-food-recall questionnaires will be administered to men (>30 years, living alone) at risk of poverty over a period of approximately 8 weeks to assess their usual food intake. At baseline and at the end a 4-week period, a FFQ and a questionnaire on consumed fruit and vegetable amounts and variety will be administered.
6774|NCT02787564|P1|Participant Flow|Free Fruit and Vegetables|"A total of four 24h-food-recall questionnaires will be administered to men (>30 years, living alone) at risk of poverty over a period of approximately 8 weeks. After baseline assessment of food intake patterns, the intervention will consist of providing free fruits and vegetables of their choice for a period of four weeks which will be provided fresh each week. At baseline and at the end of the 8-week period, a FFQ and a questionnaire on consumed fruit and vegetable amounts and variety will be administered.~Intervention Group: The intervention consists of providing free fruits and vegetables of the participants' liking for a period of 4 weeks. Each week, a total of 2 portions of either fruits and/or vegetables per day will be provided."
6775|NCT02787564|O2|Outcome|Control Group|did not receive free fresh fruits and vegetables
6776|NCT02787564|O1|Outcome|Intervention Group|received weekly 14 portions of free fresh fruits and vegetables over a period of four weeks
6777|NCT02787564|O2|Outcome|Control Group|did not receive free fresh fruits and vegetables
6778|NCT02787564|O1|Outcome|Intervention Group|received weekly 14 portions of free fresh fruits and vegetables over a period of four weeks
6779|NCT02787564|O2|Outcome|Control Group|did not receive free fresh fruits and vegetables
6780|NCT02787564|O1|Outcome|Intervention Group|received weekly 14 portions of free fresh fruits and vegetables over a period of four weeks
6781|NCT02787564|O2|Outcome|Control Group|did not receive free fresh fruits and vegetables
6782|NCT02787564|O1|Outcome|Intervention Group|received weekly 14 portions of free fresh fruits and vegetables over a period of four weeks
6783|NCT02787564|O2|Outcome|Control Group|did not receive free fresh fruits and vegetables
6784|NCT02787564|O1|Outcome|Intervention Group|received weekly 14 portions of free fresh fruits and vegetables over a period of four weeks
6785|NCT02787564|O2|Outcome|Control Group|did not receive free fresh fruits and vegetables
6786|NCT02787564|O1|Outcome|Intervention Group|received weekly 14 portions of free fresh fruits and vegetables over a period of four weeks
6787|NCT02787564|E2|Reported Event|Control Goup|Control Group: A total of four 24h-food-recall questionnaires will be administered to men (>30 years, living alone) at risk of poverty over a period of approximately 8 weeks to assess their usual food intake. At baseline and at the end a 4-week period, a FFQ and a questionnaire on consumed fruit and vegetable amounts and variety will be administered.
6831|NCT02784106|O1|Outcome|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6832|NCT02784106|O2|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6788|NCT02787564|E1|Reported Event|Free Fruit and Vegetables|"A total of four 24h-food-recall questionnaires will be administered to men (>30 years, living alone) at risk of poverty over a period of approximately 8 weeks. After baseline assessment of food intake patterns, the intervention will consist of providing free fruits and vegetables of their choice for a period of four weeks which will be provided fresh each week. At baseline and at the end of the 8-week period, a FFQ and a questionnaire on consumed fruit and vegetable amounts and variety will be administered.~Intervention Group: The intervention consists of providing free fruits and vegetables of the participants' liking for a period of 4 weeks. Each week, a total of 2 portions of either fruits and/or vegetables per day will be provided."
6789|NCT02786927|B1|Baseline|ELLIPTA and HandiHaler|Participants were randomized to receive placebo using ELLIPTA inhaler and HandiHaler inhaler once daily for 5-9 days each in a crossover manner along with their routine COPD medication.
6790|NCT02786927|P1|Participant Flow|ELLIPTA and HandiHaler|Participants were randomized to receive placebo using ELLIPTA inhaler and HandiHaler inhaler once daily for 5-9 days each in a crossover manner along with their routine COPD medication.
6791|NCT02786927|O1|Outcome|ELLIPTA and HandiHaler|Participants were randomized to receive placebo using ELLIPTA inhaler and HandiHaler inhaler once daily for 5-9 days each in a crossover manner along with their routine COPD medication.
6792|NCT02786927|O1|Outcome|ELLIPTA and HandiHaler|Participants were randomized to receive placebo using ELLIPTA inhaler and HandiHaler inhaler once daily for 5-9 days each in a crossover manner along with their routine COPD medication.
6793|NCT02786927|O1|Outcome|ELLIPTA and HandiHaler|Participants were randomized to receive placebo using ELLIPTA inhaler and HandiHaler inhaler once daily for 5-9 days each in a crossover manner along with their routine COPD medication.
6794|NCT02786927|E2|Reported Event|HandiHaler|Participants received HandiHaler inhaler at Visit 1/ Visit 2 once daily for 5-9 days.
6795|NCT02786927|E1|Reported Event|ELLIPTA|Participants received ELLIPTA inhaler at Visit 1/Visit 2 once daily for 5-9 days.
6796|NCT02786810|B1|Baseline|Contrast|"All subjects will be recruited into this arm. All subjects will receive 0.03 ml/kg IV sulfur hexafluoride type-a lipid microspheres one time, unless a second, adjusted dose is necessary.~Sulfur hexafluoride type-a lipid microspheres: Used as a contrast to enhance renal ultrasound"
6797|NCT02786810|P1|Participant Flow|Contrast|"All subjects will be recruited into this arm. All subjects will receive 0.03 ml/kg IV sulfur hexafluoride type-a lipid microspheres one time, unless a second, adjusted dose is necessary.~Sulfur hexafluoride type-a lipid microspheres: Used as a contrast to enhance renal ultrasound"
6798|NCT02786810|O1|Outcome|Contrast|"All subjects will be recruited into this arm. All subjects will receive 0.03 ml/kg IV sulfur hexafluoride type-a lipid microspheres one time, unless a second, adjusted dose is necessary.~Sulfur hexafluoride type-a lipid microspheres: Used as a contrast to enhance renal ultrasound"
6799|NCT02786810|O1|Outcome|Contrast|"All subjects will be recruited into this arm. All subjects will receive 0.03 ml/kg IV sulfur hexafluoride type-a lipid microspheres one time, unless a second, adjusted dose is necessary.~Sulfur hexafluoride type-a lipid microspheres: Used as a contrast to enhance renal ultrasound"
6800|NCT02786810|E1|Reported Event|Contrast|"All subjects will be recruited into this arm. All subjects will receive 0.03 ml/kg IV sulfur hexafluoride type-a lipid microspheres one time, unless a second, adjusted dose is necessary.~Sulfur hexafluoride type-a lipid microspheres: Used as a contrast to enhance renal ultrasound"
6801|NCT02786771|B3|Baseline|Total|Total of all reporting groups
6802|NCT02786771|B2|Baseline|Muse Device & Spire Device no Feedback|"Participants in this group will also receive Spire device to assess two weeks of baseline stress levels (with user-feedback off). Participants will be given 4 days, after enrollment, to set up their device before the 2 weeks of baseline. The 2 week baseline will start 4 days after enrollment. After these two weeks, participants will continue to use the Spire device with user feedback off for the remaining 6 weeks while they use the Muse device to manage stress through meditation. They will receive the Muse device 3 days before the end of baseline period with set up instructions and will utilize the three last days of baseline to set up their Muse device, Meditation will begin at the end of baseline (week three) and will continue for the remaining 6 weeks.~Spire~Muse headband"
6803|NCT02786771|B1|Baseline|Spire Device Without & With Feedback|"Participants will receive a Spire device with user-feedback switched off within 4 days of enrollment in the study (shipped within 2 business days after they finish enrollment survey). Participants will be given 4 days, after enrollment, to set up their device before the 2 weeks of baseline. The 2 week baseline will start 4 days after enrollment. After two weeks of baseline with user-feedback off (and a 3 day transition period), participants will turn on the user-feedback for the Spire device which would provide a relaxation aid for the participant for the 6 remaining weeks.~Spire"
6804|NCT02786771|P2|Participant Flow|Muse Device & Spire Device no Feedback|"Participants in this group will also receive Spire device to assess two weeks of baseline stress levels (with user-feedback off). Participants will be given 4 days, after enrollment, to set up their device before the 2 weeks of baseline. The 2 week baseline will start 4 days after enrollment. After these two weeks, participants will continue to use the Spire device with user feedback off for the remaining 6 weeks while they use the Muse device to manage stress through meditation. They will receive the Muse device 3 days before the end of baseline period with set up instructions and will utilize the three last days of baseline to set up their Muse device, Meditation will begin at the end of baseline (week three) and will continue for the remaining 6 weeks.~Spire~Muse headband"
6805|NCT02786771|P1|Participant Flow|Spire Device Without & With Feedback|"Participants will receive a Spire device with user-feedback switched off within 4 days of enrollment in the study (shipped within 2 business days after they finish enrollment survey). Participants will be given 4 days, after enrollment, to set up their device before the 2 weeks of baseline. The 2 week baseline will start 4 days after enrollment. After two weeks of baseline with user-feedback off (and a 3 day transition period), participants will turn on the user-feedback for the Spire device which would provide a relaxation aid for the participant for the 6 remaining weeks.~Spire"
6833|NCT02784106|O1|Outcome|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6834|NCT02784106|O2|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
11248|NCT02675907|O2|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
6806|NCT02786771|O2|Outcome|Muse Device & Spire Device no Feedback|"Participants in this group will also receive Spire device to assess two weeks of baseline stress levels (with user-feedback off). Participants will be given 4 days, after enrollment, to set up their device before the 2 weeks of baseline. The 2 week baseline will start 4 days after enrollment. After these two weeks, participants will continue to use the Spire device with user feedback off for the remaining 6 weeks while they use the Muse device to manage stress through meditation. They will receive the Muse device 3 days before the end of baseline period with set up instructions and will utilize the three last days of baseline to set up their Muse device, Meditation will begin at the end of baseline (week three) and will continue for the remaining 6 weeks.~Spire~Muse headband"
6807|NCT02786771|O1|Outcome|Spire Device Without & With Feedback|"Participants will receive a Spire device with user-feedback switched off within 4 days of enrollment in the study (shipped within 2 business days after they finish enrollment survey). Participants will be given 4 days, after enrollment, to set up their device before the 2 weeks of baseline. The 2 week baseline will start 4 days after enrollment. After two weeks of baseline with user-feedback off (and a 3 day transition period), participants will turn on the user-feedback for the Spire device which would provide a relaxation aid for the participant for the 6 remaining weeks.~Spire"
6808|NCT02786771|E2|Reported Event|Group 2|"Participants in this group will also receive Spire device to assess two weeks of baseline stress levels (with user-feedback off). Participants will be given 4 days, after enrollment, to set up their device before the 2 weeks of baseline. The 2 week baseline will start 4 days after enrollment. After these two weeks, participants will continue to use the Spire device with user feedback off for the remaining 6 weeks while they use the Muse device to manage stress through meditation. They will receive the Muse device 3 days before the end of baseline period with set up instructions and will utilize the three last days of baseline to set up their Muse device, Meditation will begin at the end of baseline (week three) and will continue for the remaining 6 weeks.~Spire~Muse headband"
6809|NCT02786771|E1|Reported Event|Group 1|"Participants will receive a Spire device with user-feedback switched off within 4 days of enrollment in the study (shipped within 2 business days after they finish enrollment survey). Participants will be given 4 days, after enrollment, to set up their device before the 2 weeks of baseline. The 2 week baseline will start 4 days after enrollment. After two weeks of baseline with user-feedback off (and a 3 day transition period), participants will turn on the user-feedback for the Spire device which would provide a relaxation aid for the participant for the 6 remaining weeks.~Spire"
6810|NCT02786004|B3|Baseline|Total|Total of all reporting groups
6811|NCT02786004|B2|Baseline|Digital Breast Tomosynthesis|"3-dimensional breast imaging~Digital Breast Tomosynthesis"
6812|NCT02786004|B1|Baseline|Full Field Digital Mammography|"2-dimensional breast imaging~Full Field Digital Mammography"
6813|NCT02786004|P2|Participant Flow|Digital Breast Tomosynthesis|"3-dimensional breast imaging~Digital Breast Tomosynthesis"
6814|NCT02786004|P1|Participant Flow|Full Field Digital Mammography|"2-dimensional breast imaging~Full Field Digital Mammography"
6815|NCT02786004|O2|Outcome|Digital Breast Tomosynthesis|"3-dimensional breast imaging~Digital Breast Tomosynthesis"
6816|NCT02786004|O1|Outcome|Full Field Digital Mammography|"2-dimensional breast imaging~Full Field Digital Mammography"
6817|NCT02786004|E2|Reported Event|Digital Breast Tomosynthesis|"3-dimensional breast imaging~Digital Breast Tomosynthesis"
6818|NCT02786004|E1|Reported Event|Full Field Digital Mammography|"2-dimensional breast imaging~Full Field Digital Mammography"
6819|NCT02784925|B1|Baseline|Fatty Liver Subjects|"Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.~Ultrasound (US) B mode image: Ultrasound (US) B mode image is an alternative method to measure tissue structure~and has proven to be an accurate technique to measure subcutaneous fat thickness."
6820|NCT02784925|P1|Participant Flow|Fatty Liver Subjects|"Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.~Ultrasound (US) B mode image: Ultrasound (US) B mode image is an alternative method to measure tissue structure~and has proven to be an accurate technique to measure subcutaneous fat thickness."
6821|NCT02784925|O1|Outcome|Fatty Liver Subjects|"Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.~Ultrasound (US) B mode image: Ultrasound (US) B mode image is an alternative method to measure tissue structure~and has proven to be an accurate technique to measure subcutaneous fat thickness."
6822|NCT02784925|E1|Reported Event|Fatty Liver Subjects|Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.Ultrasound (US) B mode image: Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.
6823|NCT02784106|B3|Baseline|Total|Total of all reporting groups
6824|NCT02784106|B2|Baseline|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6825|NCT02784106|B1|Baseline|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6826|NCT02784106|P4|Participant Flow|M2951/M2951: Open-Label Extension Period|Participants who received M2951 in double-blind treatment period, received 50 mg M2951 orally twice daily up to 26-weeks during the open-label extension period.
6827|NCT02784106|P3|Participant Flow|Placebo/M2951: Open-Label Extension Period|Participants who received placebo matched to M2951 in double-blind treatment period, received 50 mg M2951 orally twice daily up to 26-weeks during the open-label extension period.
6828|NCT02784106|P2|Participant Flow|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6829|NCT02784106|P1|Participant Flow|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6830|NCT02784106|O2|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
7035|NCT02780167|P4|Participant Flow|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
6835|NCT02784106|O1|Outcome|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6836|NCT02784106|O2|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6837|NCT02784106|O1|Outcome|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6838|NCT02784106|O1|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6839|NCT02784106|O1|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6840|NCT02784106|O1|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6841|NCT02784106|O1|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6842|NCT02784106|O1|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6843|NCT02784106|O1|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6844|NCT02784106|O1|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6845|NCT02784106|O2|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6846|NCT02784106|O1|Outcome|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6847|NCT02784106|O2|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6848|NCT02784106|O1|Outcome|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6849|NCT02784106|O2|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6850|NCT02784106|O1|Outcome|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6851|NCT02784106|O2|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6852|NCT02784106|O1|Outcome|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6853|NCT02784106|O2|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6854|NCT02784106|O1|Outcome|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6855|NCT02784106|O2|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6856|NCT02784106|O1|Outcome|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6857|NCT02784106|O2|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6858|NCT02784106|O1|Outcome|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6859|NCT02784106|O2|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6860|NCT02784106|O1|Outcome|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6861|NCT02784106|O2|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6862|NCT02784106|O1|Outcome|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6863|NCT02784106|O2|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6864|NCT02784106|O1|Outcome|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6865|NCT02784106|O2|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6866|NCT02784106|O1|Outcome|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6867|NCT02784106|O2|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6868|NCT02784106|O1|Outcome|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6869|NCT02784106|O2|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6870|NCT02784106|O1|Outcome|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6871|NCT02784106|O2|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
11512|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
6872|NCT02784106|O1|Outcome|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6873|NCT02784106|O2|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6874|NCT02784106|O1|Outcome|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6875|NCT02784106|O2|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6876|NCT02784106|O1|Outcome|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6877|NCT02784106|O2|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6878|NCT02784106|O1|Outcome|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6879|NCT02784106|O2|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6880|NCT02784106|O1|Outcome|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6881|NCT02784106|O2|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6882|NCT02784106|O1|Outcome|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6883|NCT02784106|O2|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6884|NCT02784106|O1|Outcome|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6885|NCT02784106|E4|Reported Event|M2951/M2951: Open-Label Extension Period|Participants who received M2951 in double-blind treatment period, received 50 mg M2951 orally twice daily up to 26-weeks during the open-label extension period.
6886|NCT02784106|E3|Reported Event|Placebo/M2951: Open-Label Extension Period|Participants who received placebo matched to M2951 in double-blind treatment period, received 50 mg M2951 orally twice daily up to 26-weeks during the open-label extension period.
6887|NCT02784106|E2|Reported Event|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
6888|NCT02784106|E1|Reported Event|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
6889|NCT02782676|B1|Baseline|Subjects Received OVD (Bacterial and/or Animal-Derived)|"Subject received study OVD (Bacterial and/or Animal Derived) in either eye.~(NOTE: subject numbers includes both the paired-eyes and non-paired eye participants)"
6890|NCT02782676|P2|Participant Flow|Approved Healon5 OVD (Animal-Derived)|"Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Healon5 OVD: ophthalmic viscosurgical device"
6891|NCT02782676|P1|Participant Flow|Investigational Healon5 OVD (Bacterially-Derived)|"Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Investigational Healon5 OVD: ophthalmic viscosurgical device"
6892|NCT02782676|O2|Outcome|Approved Healon5 OVD (Animal-Derived)|"Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Healon5 OVD: ophthalmic viscosurgical device"
6893|NCT02782676|O1|Outcome|Investigational Healon5 OVD (Bacterially-Derived)|"Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Investigational Healon5 OVD: ophthalmic viscosurgical device"
6894|NCT02782676|O2|Outcome|Approved Healon5 OVD (Animal-Derived)|"Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Healon5 OVD: ophthalmic viscosurgical device"
6895|NCT02782676|O1|Outcome|Investigational Healon5 OVD (Bacterially-Derived)|"Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Investigational Healon5 OVD: ophthalmic viscosurgical device"
6896|NCT02782676|O2|Outcome|Approved Healon5 OVD (Animal-Derived)|"Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Healon5 OVD: ophthalmic viscosurgical device"
6897|NCT02782676|O1|Outcome|Investigational Healon5 OVD (Bacterially-Derived)|"Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Investigational Healon5 OVD: ophthalmic viscosurgical device"
6898|NCT02782676|O2|Outcome|Approved Healon5 OVD (Animal-Derived)|"Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Healon5 OVD: ophthalmic viscosurgical device"
6899|NCT02782676|O1|Outcome|Investigational Healon5 OVD (Bacterially-Derived)|"Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Investigational Healon5 OVD: ophthalmic viscosurgical device"
6900|NCT02782676|O2|Outcome|Approved Healon5 OVD (Animal-Derived)|"Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Healon5 OVD: ophthalmic viscosurgical device"
6901|NCT02782676|O1|Outcome|Investigational Healon5 OVD (Bacterially-Derived)|"Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Investigational Healon5 OVD: ophthalmic viscosurgical device"
6902|NCT02782676|O2|Outcome|Approved Healon5 OVD (Animal-Derived)|"Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Healon5 OVD: ophthalmic viscosurgical device"
6903|NCT02782676|O1|Outcome|Investigational Healon5 OVD (Bacterially-Derived)|"Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Investigational Healon5 OVD: ophthalmic viscosurgical device"
6904|NCT02782676|O2|Outcome|Approved Healon5 OVD (Animal-Derived)|"Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Healon5 OVD: ophthalmic viscosurgical device"
6946|NCT02781818|O2|Outcome|Triamcinolone Acetonide 40mg/mL|Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 40mg/mL solution.
6905|NCT02782676|O1|Outcome|Investigational Healon5 OVD (Bacterially-Derived)|"Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Investigational Healon5 OVD: ophthalmic viscosurgical device"
6906|NCT02782676|O2|Outcome|Approved Healon5 OVD (Animal-Derived)|"Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Healon5 OVD: ophthalmic viscosurgical device"
6907|NCT02782676|O1|Outcome|Investigational Healon5 OVD (Bacterially-Derived)|"Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Investigational Healon5 OVD: ophthalmic viscosurgical device"
6908|NCT02782676|O2|Outcome|Approved Healon5 OVD (Animal-Derived)|"Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Healon5 OVD: ophthalmic viscosurgical device"
6909|NCT02782676|O1|Outcome|Investigational Healon5 OVD (Bacterially-Derived)|"Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Investigational Healon5 OVD: ophthalmic viscosurgical device"
6910|NCT02782676|O2|Outcome|Approved Healon5 OVD (Animal-Derived)|"Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Healon5 OVD: ophthalmic viscosurgical device"
6911|NCT02782676|O1|Outcome|Investigational Healon5 OVD (Bacterially-Derived)|"Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Investigational Healon5 OVD: ophthalmic viscosurgical device"
6912|NCT02782676|O2|Outcome|Approved Healon5 OVD (Animal-Derived)|"Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Healon5 OVD: ophthalmic viscosurgical device"
6913|NCT02782676|O1|Outcome|Investigational Healon5 OVD (Bacterially-Derived)|"Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Investigational Healon5 OVD: ophthalmic viscosurgical device"
6914|NCT02782676|O2|Outcome|Approved Healon5 OVD (Animal-Derived)|"Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Healon5 OVD: ophthalmic viscosurgical device"
6915|NCT02782676|O1|Outcome|Investigational Healon5 OVD (Bacterially-Derived)|"Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Investigational Healon5 OVD: ophthalmic viscosurgical device"
6916|NCT02782676|E2|Reported Event|Approved Healon5 OVD|"Subjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Healon5 OVD: ophthalmic viscosurgical device"
6917|NCT02782676|E1|Reported Event|Investigational Healon5 OVD|"Subjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Investigational Healon5 OVD: ophthalmic viscosurgical device"
6918|NCT02782169|B3|Baseline|Total|Total of all reporting groups
6919|NCT02782169|B2|Baseline|Placebo|Placebo: Matching placebo capsule with excipient to match Pregabalin
6920|NCT02782169|B1|Baseline|Pregabalin|Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)
6921|NCT02782169|P2|Participant Flow|Placebo|Placebo: Matching placebo capsule with excipient to match Pregabalin
6922|NCT02782169|P1|Participant Flow|Pregabalin|Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)
6923|NCT02782169|O2|Outcome|Placebo|Placebo: Matching placebo capsule with excipient to match Pregabalin
6924|NCT02782169|O1|Outcome|Pregabalin|Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)
6925|NCT02782169|O2|Outcome|Placebo|Placebo: Matching placebo capsule with excipient to match Pregabalin
6926|NCT02782169|O1|Outcome|Pregabalin|Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)
6927|NCT02782169|O2|Outcome|Placebo|Placebo: Matching placebo capsule with excipient to match Pregabalin
6928|NCT02782169|O1|Outcome|Pregabalin|Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)
6929|NCT02782169|O2|Outcome|Placebo|Placebo: Matching placebo capsule with excipient to match Pregabalin
6930|NCT02782169|O1|Outcome|Pregabalin|Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)
6931|NCT02782169|O2|Outcome|Placebo|Placebo: Matching placebo capsule with excipient to match Pregabalin
6932|NCT02782169|O1|Outcome|Pregabalin|Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)
6933|NCT02782169|E2|Reported Event|Placebo|Placebo: Matching placebo capsule with excipient to match Pregabalin
6934|NCT02782169|E1|Reported Event|Pregabalin|Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)
6935|NCT02781818|B4|Baseline|Total|Total of all reporting groups
6936|NCT02781818|B3|Baseline|Normal Saline Placebo|Each lesion randomized to this group received a single intralesional treatment with non-bacteriostatic 0.1mL of sterile normal saline solution.
6937|NCT02781818|B2|Baseline|Triamcinolone Acetonide 40mg/mL|Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 40mg/mL solution.
6938|NCT02781818|B1|Baseline|Triamcinolone Acetonide 10mg/mL|Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 10mg/mL solution.
6939|NCT02781818|P3|Participant Flow|Normal Saline Placebo|Each lesion randomized to this group received a single intralesional treatment with non-bacteriostatic 0.1 mL of sterile normal saline solution.
6940|NCT02781818|P2|Participant Flow|Triamcinolone Acetonide 40mg/mL|Each lesion randomized to this group received a single intralesional treatment with 0.1 mL of triamcinolone 40mg/mL solution.
6941|NCT02781818|P1|Participant Flow|Triamcinolone Acetonide 10mg/mL|Each lesion randomized to this group received a single intralesional treatment with 0.1 mL of triamcinolone 10mg/mL solution.
6942|NCT02781818|O3|Outcome|Normal Saline Placebo|Each lesion randomized to this group received a single intralesional treatment with non-bacteriostatic 0.1mL of sterile normal saline solution.
6943|NCT02781818|O2|Outcome|Triamcinolone Acetonide 40mg/mL|Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 40mg/mL solution.
6944|NCT02781818|O1|Outcome|Triamcinolone Acetonide 10mg/mL|Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 10mg/mL solution.
6945|NCT02781818|O3|Outcome|Normal Saline Placebo|Each lesion randomized to this group received a single intralesional treatment with non-bacteriostatic 0.1mL of sterile normal saline solution.
7025|NCT02780349|P1|Participant Flow|WIRION EPS|WIRION: Embolic Protection System
6947|NCT02781818|O1|Outcome|Triamcinolone Acetonide 10mg/mL|Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 10mg/mL solution.
6948|NCT02781818|O3|Outcome|Normal Saline Placebo|Each lesion randomized to this group received a single intralesional treatment with non-bacteriostatic 0.1mL of sterile normal saline solution.
6949|NCT02781818|O2|Outcome|Triamcinolone Acetonide 40mg/mL|Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 40mg/mL solution.
6950|NCT02781818|O1|Outcome|Triamcinolone Acetonide 10mg/mL|Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 10mg/mL solution.
6951|NCT02781818|E3|Reported Event|Normal Saline Placebo|"Each lesion randomized to this group will receive a single intralesional treatment with 0.1mL of sterile normal saline solution.~Normal Saline: Normal saline 0.1mL will be administered intralesionally at the selected site."
6952|NCT02781818|E2|Reported Event|Triamcinolone Acetonide 40mg/mL|"Each lesion randomized to this group will receive a single intralesional treatment with 0.1mL of triamcinolone 40mg/mL solution.~Triamcinolone Acetonide 40mg/mL: Triamcinolone acetonide is a glucocorticoid used in intralesional treatment of many skin diseases, intra-articular treatment of inflammatory joint diseases, and intramuscular treatment for systemic management of systemic inflammatory diseases. It is commonly used in clinical practice for the treatment of acute abscesses and nodules of hidradenitis suppurativa, but little clinical trial data exist supporting its use."
6953|NCT02781818|E1|Reported Event|Triamcinolone Acetonide 10mg/mL|"Each lesion randomized to this group will receive a single intralesional treatment with 0.1mL of triamcinolone 10mg/mL solution.~Triamcinolone Acetonide 10mg/mL: Triamcinolone acetonide is a glucocorticoid used in intralesional treatment of many skin diseases, intra-articular treatment of inflammatory joint diseases, and intramuscular treatment for systemic management of systemic inflammatory diseases. It is commonly used in clinical practice for the treatment of acute abscesses and nodules of hidradenitis suppurativa, but little clinical trial data exist supporting its use."
6954|NCT02781649|B4|Baseline|Total|Total of all reporting groups
6955|NCT02781649|B3|Baseline|Donor Genotype 2 or 3|"Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Sofosbuvir: Sofosbuvir 400 mg daily"
6956|NCT02781649|B2|Baseline|Donor Genotype 1a With Resistance|"Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Ribavirin: Ribavirin 1200 mg/d (> 75 kg) or 1000 mg/d (< 75 kg) by mouth daily in two divided doses"
6957|NCT02781649|B1|Baseline|Donor Genotype 1a no Resistance or 1b|"Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks"
6958|NCT02781649|P3|Participant Flow|Donor Genotype 2 or 3|"Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Sofosbuvir: Sofosbuvir 400 mg daily"
6959|NCT02781649|P2|Participant Flow|Donor Genotype 1a With Resistance|"Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Ribavirin: Ribavirin 1200 mg/d (> 75 kg) or 1000 mg/d (< 75 kg) by mouth daily in two divided doses"
6960|NCT02781649|P1|Participant Flow|Donor Genotype 1a no Resistance or 1b|"Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks"
6961|NCT02781649|O3|Outcome|Donor Genotype 2 or 3|"Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Sofosbuvir: Sofosbuvir 400 mg daily"
6962|NCT02781649|O2|Outcome|Donor Genotype 1a With Resistance|"Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Ribavirin: Ribavirin 1200 mg/d (> 75 kg) or 1000 mg/d (< 75 kg) by mouth daily in two divided doses"
6963|NCT02781649|O1|Outcome|Donor Genotype 1a no Resistance or 1b|"Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks"
6964|NCT02781649|O3|Outcome|Donor Genotype 2 or 3|"Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Sofosbuvir: Sofosbuvir 400 mg daily"
6965|NCT02781649|O2|Outcome|Donor Genotype 1a With Resistance|"Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Ribavirin: Ribavirin 1200 mg/d (> 75 kg) or 1000 mg/d (< 75 kg) by mouth daily in two divided doses"
6966|NCT02781649|O1|Outcome|Donor Genotype 1a no Resistance or 1b|"Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks"
6967|NCT02781649|O3|Outcome|Donor Genotype 2 or 3|"Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Sofosbuvir: Sofosbuvir 400 mg daily"
6968|NCT02781649|O2|Outcome|Donor Genotype 1a With Resistance|"Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Ribavirin: Ribavirin 1200 mg/d (> 75 kg) or 1000 mg/d (< 75 kg) by mouth daily in two divided doses"
6969|NCT02781649|O1|Outcome|Donor Genotype 1a no Resistance or 1b|"Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks"
6970|NCT02781649|O3|Outcome|Donor Genotype 2 or 3|"Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Sofosbuvir: Sofosbuvir 400 mg daily"
6971|NCT02781649|O2|Outcome|Donor Genotype 1a With Resistance|"Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Ribavirin: Ribavirin 1200 mg/d (> 75 kg) or 1000 mg/d (< 75 kg) by mouth daily in two divided doses"
6972|NCT02781649|O1|Outcome|Donor Genotype 1a no Resistance or 1b|"Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks"
6973|NCT02781649|O3|Outcome|Donor Genotype 2 or 3|"Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Sofosbuvir: Sofosbuvir 400 mg daily"
6974|NCT02781649|O2|Outcome|Donor Genotype 1a With Resistance|"Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Ribavirin: Ribavirin 1200 mg/d (> 75 kg) or 1000 mg/d (< 75 kg) by mouth daily in two divided doses"
6975|NCT02781649|O1|Outcome|Donor Genotype 1a no Resistance or 1b|"Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks"
6976|NCT02781649|O3|Outcome|Donor Genotype 2 or 3|"Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Sofosbuvir: Sofosbuvir 400 mg daily"
6977|NCT02781649|O2|Outcome|Donor Genotype 1a With Resistance|"Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Ribavirin: Ribavirin 1200 mg/d (> 75 kg) or 1000 mg/d (< 75 kg) by mouth daily in two divided doses"
6978|NCT02781649|O1|Outcome|Donor Genotype 1a no Resistance or 1b|"Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks"
6979|NCT02781649|O3|Outcome|Donor Genotype 2 or 3|"Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Sofosbuvir: Sofosbuvir 400 mg daily"
6980|NCT02781649|O2|Outcome|Donor Genotype 1a With Resistance|"Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Ribavirin: Ribavirin 1200 mg/d (> 75 kg) or 1000 mg/d (< 75 kg) by mouth daily in two divided doses"
6981|NCT02781649|O1|Outcome|Donor Genotype 1a no Resistance or 1b|"Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks"
6982|NCT02781649|E3|Reported Event|Donor Genotype 2 or 3|"Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Sofosbuvir: Sofosbuvir 400 mg daily"
6983|NCT02781649|E2|Reported Event|Donor Genotype 1a With Resistance|"Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Ribavirin: Ribavirin 1200 mg/d (> 75 kg) or 1000 mg/d (< 75 kg) by mouth daily in two divided doses"
6984|NCT02781649|E1|Reported Event|Donor Genotype 1a no Resistance or 1b|"Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks"
6985|NCT02780622|B1|Baseline|All Participants|Participants were randomized to 1 of 2 treatment sequences: warfarin then oseltamivir 75 mg and warfarin; or oseltamivir 75 mg and warfarin then warfarin.
6986|NCT02780622|P2|Participant Flow|First Warfarin and Oseltamivir Then Warfarin|Participants received oseltamivir 75 mg (orally twice daily on Days 1-4 and once on Day 5) and warfarin in Treatment Period 1, followed by a washout period of at least 4 days (maximum 8 days). Participants then received warfarin (on Days 1-5) in Treatment Period 2, and attended a follow-up visit 4-12 days after the last dose in Treatment Period 2. Participants continued to receive warfarin once daily at a prescribed usual dose throughout the study.
6987|NCT02780622|P1|Participant Flow|First Warfarin Then Warfarin and Oseltamivir|Participants received warfarin (on Days 1-5) in Treatment Period 1, followed by a washout period of at least 4 days (maximum 8 days). Participants then received oseltamivir 75 milligram (mg) (orally twice daily on Days 1-4 and once on Day 5) and warfarin in Treatment Period 2, and attended a follow-up visit 4-12 days after the last dose in Treatment Period 2. Participants continued to receive warfarin once daily at a prescribed usual dose throughout the study.
6988|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
6989|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
7026|NCT02780349|O1|Outcome|Single Arm|WIRION: Embolic Protection System
6990|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
6991|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
6992|NCT02780622|O1|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
6993|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
6994|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
6995|NCT02780622|O1|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
6996|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
6997|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
6998|NCT02780622|O1|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
6999|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
7000|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
7001|NCT02780622|O1|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
7002|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
7003|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
7004|NCT02780622|O1|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
7005|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
7006|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
7007|NCT02780622|O1|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
7008|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
7009|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
7010|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
7011|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
7012|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
7013|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
7014|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
7015|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
7016|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
7017|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
7018|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
7019|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
7020|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
7021|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
7022|NCT02780622|E2|Reported Event|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
7023|NCT02780622|E1|Reported Event|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
7024|NCT02780349|B1|Baseline|Single Arm|WIRION: Embolic Protection System
7036|NCT02780167|P3|Participant Flow|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7037|NCT02780167|P2|Participant Flow|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7038|NCT02780167|P1|Participant Flow|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
7039|NCT02780167|O5|Outcome|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
7040|NCT02780167|O4|Outcome|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
7041|NCT02780167|O3|Outcome|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7042|NCT02780167|O2|Outcome|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7043|NCT02780167|O1|Outcome|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
7044|NCT02780167|O5|Outcome|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
7045|NCT02780167|O4|Outcome|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
7046|NCT02780167|O3|Outcome|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7047|NCT02780167|O2|Outcome|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7048|NCT02780167|O1|Outcome|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
7049|NCT02780167|O5|Outcome|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
7050|NCT02780167|O4|Outcome|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
7051|NCT02780167|O3|Outcome|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7052|NCT02780167|O2|Outcome|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7053|NCT02780167|O1|Outcome|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
7054|NCT02780167|O5|Outcome|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
7055|NCT02780167|O4|Outcome|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
7056|NCT02780167|O3|Outcome|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7057|NCT02780167|O2|Outcome|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7058|NCT02780167|O1|Outcome|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
7059|NCT02780167|O5|Outcome|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
7060|NCT02780167|O4|Outcome|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
7061|NCT02780167|O3|Outcome|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7062|NCT02780167|O2|Outcome|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7063|NCT02780167|O1|Outcome|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
7064|NCT02780167|O5|Outcome|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
7065|NCT02780167|O4|Outcome|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
7066|NCT02780167|O3|Outcome|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7067|NCT02780167|O2|Outcome|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7068|NCT02780167|O1|Outcome|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
7069|NCT02780167|O5|Outcome|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
7070|NCT02780167|O4|Outcome|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
7071|NCT02780167|O3|Outcome|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7072|NCT02780167|O2|Outcome|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7073|NCT02780167|O1|Outcome|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
7074|NCT02780167|O5|Outcome|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
7075|NCT02780167|O4|Outcome|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
7076|NCT02780167|O3|Outcome|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7077|NCT02780167|O2|Outcome|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7078|NCT02780167|O1|Outcome|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
7079|NCT02780167|O5|Outcome|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
7080|NCT02780167|O4|Outcome|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
7081|NCT02780167|O3|Outcome|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7082|NCT02780167|O2|Outcome|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7084|NCT02780167|O5|Outcome|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
7085|NCT02780167|O4|Outcome|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
7086|NCT02780167|O3|Outcome|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7087|NCT02780167|O2|Outcome|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7088|NCT02780167|O1|Outcome|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
7089|NCT02780167|O5|Outcome|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
7090|NCT02780167|O4|Outcome|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
7091|NCT02780167|O3|Outcome|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7092|NCT02780167|O2|Outcome|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7093|NCT02780167|O1|Outcome|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
7094|NCT02780167|O5|Outcome|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
7095|NCT02780167|O4|Outcome|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
7096|NCT02780167|O3|Outcome|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7097|NCT02780167|O2|Outcome|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7098|NCT02780167|O1|Outcome|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
7099|NCT02780167|O5|Outcome|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
7100|NCT02780167|O4|Outcome|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
7101|NCT02780167|O3|Outcome|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7102|NCT02780167|O2|Outcome|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7103|NCT02780167|O1|Outcome|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
7104|NCT02780167|O5|Outcome|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
7105|NCT02780167|O4|Outcome|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
7106|NCT02780167|O3|Outcome|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7107|NCT02780167|O2|Outcome|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7108|NCT02780167|O1|Outcome|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
7109|NCT02780167|O5|Outcome|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
7110|NCT02780167|O4|Outcome|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
7111|NCT02780167|O3|Outcome|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7112|NCT02780167|O2|Outcome|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7113|NCT02780167|O1|Outcome|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
7114|NCT02780167|O5|Outcome|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
7115|NCT02780167|O4|Outcome|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
7116|NCT02780167|O3|Outcome|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7117|NCT02780167|O2|Outcome|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7118|NCT02780167|O1|Outcome|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
7119|NCT02780167|O5|Outcome|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
7120|NCT02780167|O4|Outcome|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
7121|NCT02780167|O3|Outcome|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7122|NCT02780167|O2|Outcome|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7123|NCT02780167|O1|Outcome|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
7124|NCT02780167|O5|Outcome|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
7125|NCT02780167|O4|Outcome|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
7126|NCT02780167|O3|Outcome|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7127|NCT02780167|O2|Outcome|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7128|NCT02780167|O1|Outcome|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
7129|NCT02780167|O5|Outcome|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
7130|NCT02780167|O4|Outcome|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
7131|NCT02780167|O3|Outcome|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7132|NCT02780167|O2|Outcome|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7133|NCT02780167|O1|Outcome|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
7134|NCT02780167|O5|Outcome|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
7135|NCT02780167|O4|Outcome|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
7136|NCT02780167|O3|Outcome|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7137|NCT02780167|O2|Outcome|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7138|NCT02780167|O1|Outcome|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
7139|NCT02780167|O5|Outcome|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
7140|NCT02780167|O4|Outcome|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
7141|NCT02780167|O3|Outcome|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7142|NCT02780167|O2|Outcome|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7143|NCT02780167|O1|Outcome|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
7144|NCT02780167|O5|Outcome|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
7145|NCT02780167|O4|Outcome|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
7146|NCT02780167|O3|Outcome|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7147|NCT02780167|O2|Outcome|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7148|NCT02780167|O1|Outcome|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
7149|NCT02780167|O5|Outcome|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
7150|NCT02780167|O4|Outcome|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
7151|NCT02780167|O3|Outcome|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7152|NCT02780167|O2|Outcome|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7153|NCT02780167|O1|Outcome|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
7154|NCT02780167|O5|Outcome|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
7155|NCT02780167|O4|Outcome|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
7156|NCT02780167|O3|Outcome|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7157|NCT02780167|O2|Outcome|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7158|NCT02780167|O1|Outcome|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
7159|NCT02780167|O5|Outcome|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
7160|NCT02780167|O4|Outcome|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
7161|NCT02780167|O3|Outcome|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7162|NCT02780167|O2|Outcome|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7163|NCT02780167|O1|Outcome|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
7164|NCT02780167|E5|Reported Event|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
7165|NCT02780167|E4|Reported Event|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
7166|NCT02780167|E3|Reported Event|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
7167|NCT02780167|E2|Reported Event|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
7168|NCT02780167|E1|Reported Event|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
7169|NCT02777931|B3|Baseline|Total|Total of all reporting groups
7170|NCT02777931|B2|Baseline|Placebo|Matching placebo capsules
7171|NCT02777931|B1|Baseline|NFC-1|Doses of NFC-1 will be administered as 100, 200, or 400 mg twice daily as capsules (size 2 hard gelatin capsules).
7172|NCT02777931|P2|Participant Flow|Placebo|Matching placebo capsules
7173|NCT02777931|P1|Participant Flow|NFC-1|Doses of NFC-1 will be administered as 100, 200, or 400 mg twice daily as capsules (size 2 hard gelatin capsules).
7174|NCT02777931|O2|Outcome|Placebo|Matching placebo capsules
7175|NCT02777931|O1|Outcome|NFC-1|Doses of NFC-1 will be administered as 100, 200, or 400 mg twice daily as capsules (size 2 hard gelatin capsules).
7176|NCT02777931|O2|Outcome|Placebo|Matching placebo capsules
7177|NCT02777931|O1|Outcome|NFC-1|Doses of NFC-1 will be administered as 100, 200, or 400 mg twice daily as capsules (size 2 hard gelatin capsules).
7178|NCT02777931|E2|Reported Event|Placebo|Matching placebo capsules
7179|NCT02777931|E1|Reported Event|NFC-1|Doses of NFC-1 will be administered as 100, 200, or 400 mg twice daily as capsules (size 2 hard gelatin capsules).
11513|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
7180|NCT02777268|B1|Baseline|All Study Participants|"5-way crossover study design involving Infacort and hydrocortisone at the following dose strengths:~Infacort 0.5mg Infacort 2mg Infacort 5mg Infacort 10mg Hydrocortisone 10mg~Each IMP was administered to each subject in a randomised, crossover manner over 5 treatment periods (1 treatment/period). During each treatment period, each subject was admitted to the Unit on the afternoon of Day 1 and remained in the Unit until completion of all scheduled assessments on Day 2. Each subject received their scheduled IMP on the morning of Day 2 at ~0700hrs (fasted). Each subject also received 1mg dexamethasone (to suppress endogenous cortisol production) at approximately 2200hrs on Day 1, and at approximately 0600hrs and 1200hrs on Day 2. All doses were administered with 200mL water. There were at least 7 days washout between each dose of IMP."
7181|NCT02777268|P1|Participant Flow|All Study Participants|"5-way crossover study design involving Infacort and hydrocortisone at the following dose strengths:~Infacort 0.5mg Infacort 2mg Infacort 5mg Infacort 10mg Hydrocortisone 10mg~Each IMP was administered to each subject in a randomised, crossover manner over 5 treatment periods (1 treatment/period). During each treatment period, each subject was admitted to the Unit on the afternoon of Day 1 and remained in the Unit until completion of all scheduled assessments on Day 2. Each subject received their scheduled IMP on the morning of Day 2 at ~0700hrs (fasted). Each subject also received 1mg dexamethasone (to suppress endogenous cortisol production) at approximately 2200hrs on Day 1, and at approximately 0600hrs and 1200hrs on Day 2. All doses were administered with 200mL water. There were at least 7 days washout between each dose of IMP."
7182|NCT02777268|O1|Outcome|All Study Participants|"5-way crossover study design involving Infacort and hydrocortisone at the following dose strengths:~Infacort 0.5mg Infacort 2mg Infacort 5mg Infacort 10mg Hydrocortisone 10mg~Each IMP was administered to each subject in a randomised, crossover manner over 5 treatment periods (1 treatment/period). During each treatment period, each subject was admitted to the Unit on the afternoon of Day 1 and remained in the Unit until completion of all scheduled assessments on Day 2. Each subject received their scheduled IMP on the morning of Day 2 at ~0700hrs (fasted). Each subject also received 1mg dexamethasone (to suppress endogenous cortisol production) at approximately 2200hrs on Day 1, and at approximately 0600hrs and 1200hrs on Day 2. All doses were administered with 200mL water. There were at least 7 days washout between each dose of IMP."
7183|NCT02777268|O4|Outcome|Infacort 10 mg|"Multi-particulate granules from 1 (10 mg) capsule~Infacort: Multi-particulate granules"
7184|NCT02777268|O3|Outcome|Infacort 5 mg|"Multi-particulate granules from 1 (5 mg) capsule~Infacort: Multi-particulate granules"
7185|NCT02777268|O2|Outcome|Infacort 2 mg|"Multi-particulate granules from 1 (2 mg) capsule~Infacort: Multi-particulate granules"
7186|NCT02777268|O1|Outcome|Infacort 0.5 mg|"Multi-particulate granules from 1 (0.5 mg) capsule~Infacort: Multi-particulate granules"
7187|NCT02777268|O4|Outcome|Infacort 10 mg|"Multi-particulate granules from 1 (10 mg) capsule~Infacort: Multi-particulate granules"
7188|NCT02777268|O3|Outcome|Infacort 5 mg|"Multi-particulate granules from 1 (5 mg) capsule~Infacort: Multi-particulate granules"
7189|NCT02777268|O2|Outcome|Infacort 2 mg|"Multi-particulate granules from 1 (2 mg) capsule~Infacort: Multi-particulate granules"
7190|NCT02777268|O1|Outcome|Infacort 0.5 mg|"Multi-particulate granules from 1 (0.5 mg) capsule~Infacort: Multi-particulate granules"
7191|NCT02777268|O4|Outcome|Infacort 10mg|"Multi-particulate granules from 1 (10mg) capsule~Infacort: Multi-particulate granules"
7192|NCT02777268|O3|Outcome|Infacort 5mg|"Multi-particulate granules from 1 (5mg) capsule~Infacort: Multi-particulate granules"
7193|NCT02777268|O2|Outcome|Infacort 2mg|"Multi-particulate granules from 1 (2mg) capsule~Infacort: Multi-particulate granules"
7194|NCT02777268|O1|Outcome|Infacort 0.5mg|"Multi-particulate granules from 1 (0.5 mg) capsule~Infacort: Multi-particulate granules"
7195|NCT02777268|O2|Outcome|Hydrocortisone|1 (10 mg) hydrocortisone tablet
7196|NCT02777268|O1|Outcome|Infacort 10 mg|Multi-particulate granules from 1 Infacort 10 mg capsule
7197|NCT02777268|O2|Outcome|Hydrocortisone|10 mg hydrocortisone tablet
7198|NCT02777268|O1|Outcome|Infacort 10mg|Multi-particulate granules from a 10mg Infacort capsule.
7199|NCT02777268|O2|Outcome|Hydrocortisone|"1 (10 mg) tablet~Hydrocortisone: Tablet"
7200|NCT02777268|O1|Outcome|Infacort 10mg|Multi-particulate granules from 10mg Infacort capsule
7201|NCT02777268|E5|Reported Event|Hydrocortisone|"1 (10 mg) tablet~Hydrocortisone: Tablet"
7202|NCT02777268|E4|Reported Event|Infacort 10 mg|"Multi-particulate granules from 1 (10 mg) capsule~Infacort: Multi-particulate granules"
7203|NCT02777268|E3|Reported Event|Infacort 5 mg|"Multi-particulate granules from 1 (5 mg) capsule~Infacort: Multi-particulate granules"
7204|NCT02777268|E2|Reported Event|Infacort 2 mg|"Multi-particulate granules from 1 (2 mg) capsule~Infacort: Multi-particulate granules"
7205|NCT02777268|E1|Reported Event|Infacort 0.5 mg|"Multi-particulate granules from 1 (0.5 mg) capsule~Infacort: Multi-particulate granules"
7206|NCT02777242|B1|Baseline|Testosterone Enanthate Auto-injector|Testosterone enanthate administered subcutaneously once each week via auto-injector of QST 50 mg or 75 mg or 100 mg [Device: QuickShot® Testosterone (QST)]
7207|NCT02777242|P1|Participant Flow|Testosterone Enanthate Auto-injector|Testosterone enanthate administered subcutaneously once each week via auto-injector of QST 50 mg or 75 mg or 100 mg [Device: QuickShot® Testosterone (QST)]
7208|NCT02777242|O1|Outcome|Testosterone Enanthate Auto-injector|Testosterone enanthate administered subcutaneously once each week via auto-injector of QST 50 mg or 75 mg or 100 mg [Device: QuickShot® Testosterone (QST)]
7209|NCT02777242|E1|Reported Event|Testosterone Enanthate Auto-injector|Testosterone enanthate administered subcutaneously once each week via auto-injector of QST 50 mg or 75 mg or 100 mg [Device: QuickShot® Testosterone (QST)]
7210|NCT02777125|B3|Baseline|Total|Total of all reporting groups
7229|NCT02774343|B1|Baseline|Pioglitazone + Therapy + Contingency Management|"Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7267|NCT02774278|P1|Participant Flow|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
7211|NCT02777125|B2|Baseline|Albuterol Breath Actuated Nebulizer|"Subjects randomized to BAN were evaluated for proper breath actuation technique. The device settings were changed to provide continuous nebulization with a facemask if the patient could not breath actuate. Children presenting in the mild and moderate severity category weighing less than 20kg, received 2500mcg of albuterol. Children weighing more than 20kg, received 2500mcg of albuterol if their presentation met mild severity criteria, or 5000mcg if they met moderate criteria.~Breath Actuated Nebulizer: The breath actuated nebulizer (BAN) device is a device that converts liquid medication, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be attached to a mask and set to continuous nebulization for patients that are not able to coordinate their breaths."
7212|NCT02777125|B1|Baseline|Albuterol by Metered Dose Inhaler|"Albuterol administered via MDI and spacer device with weight and severity based dosing. For weight less than 20 kg: mild and moderate disease 540mcg of albuterol per dose. For weight greater than or equal to 20 kg: mild disease 540 mcg of albuterol per dose and moderate disease 1080 mcg of albuterol per dose.~Metered Dose Inhaler: A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths."
7213|NCT02777125|P2|Participant Flow|Albuterol Breath Actuated Nebulizer|"Subjects randomized to BAN were evaluated for proper breath actuation technique. The device settings were changed to provide continuous nebulization with a facemask if the patient could not breath actuate. Children presenting in the mild and moderate severity category weighing less than 20kg, received 2500mcg of albuterol. Children weighing more than 20kg, received 2500mcg of albuterol if their presentation met mild severity criteria, or 5000mcg if they met moderate criteria.~Breath Actuated Nebulizer: The breath actuated nebulizer (BAN) device is a device that converts liquid medication, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be attached to a mask and set to continuous nebulization for patients that are not able to coordinate their breaths."
7214|NCT02777125|P1|Participant Flow|Albuterol by Metered Dose Inhaler|"Albuterol administered via MDI and spacer device with weight and severity based dosing. For weight less than 20 kg: mild and moderate disease 540mcg of albuterol per dose. For weight greater than or equal to 20 kg: mild disease 540 mcg of albuterol per dose and moderate disease 1080 mcg of albuterol per dose.~Metered Dose Inhaler: A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths."
7215|NCT02777125|O2|Outcome|Albuterol Breath Actuated Nebulizer|"Subjects randomized to BAN were evaluated for proper breath actuation technique. For subjects unable to breath actuate, the RT changed the device setting to continuous nebulization, provided an appropriately sized mask, and returned upon completion of the treatment. Albuterol dosing was based upon the subject’s weight and presenting symptom severity. Children presenting in the mild and moderate severity category weighing less than 20kg, received 2500mcg of albuterol. Children weighing more than 20kg, received 2500mcg of albuterol if their presentation met mild severity criteria, or 5000mcg if they met moderate criteria.~Breath Actuated Nebulizer: The breath actuated nebulizer (BAN) device is a device that converts liquid medication, in this case albuterol, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be atta"
7216|NCT02777125|O1|Outcome|Albuterol by Metered Dose Inhaler|"Albuterol administered via MDI and spacer device with weight and severity based dosing. For weight less than 20 kg: mild and moderate disease 540mcg of albuterol per dose. For weight greater than or equal to 20 kg: mild disease 540 mcg of albuterol per dose and moderate disease 1080 mcg of albuterol per dose.~Metered Dose Inhaler: A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths."
7217|NCT02777125|O2|Outcome|Albuterol Breath Actuated Nebulizer|"Subjects randomized to BAN were evaluated for proper breath actuation technique. For subjects unable to breath actuate, the RT changed the device setting to continuous nebulization, provided an appropriately sized mask, and returned upon completion of the treatment. Albuterol dosing was based upon the subject’s weight and presenting symptom severity. Children presenting in the mild and moderate severity category weighing less than 20kg, received 2500mcg of albuterol. Children weighing more than 20kg, received 2500mcg of albuterol if their presentation met mild severity criteria, or 5000mcg if they met moderate criteria.~Breath Actuated Nebulizer: The breath actuated nebulizer (BAN) device is a device that converts liquid medication, in this case albuterol, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be atta"
7218|NCT02777125|O1|Outcome|Albuterol by Metered Dose Inhaler|"Albuterol administered via MDI and spacer device with weight and severity based dosing. For weight less than 20 kg: mild and moderate disease 540mcg of albuterol per dose. For weight greater than or equal to 20 kg: mild disease 540 mcg of albuterol per dose and moderate disease 1080 mcg of albuterol per dose.~Metered Dose Inhaler: A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths."
7230|NCT02774343|P2|Participant Flow|Placebo + Therapy + Contingency Management|"Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7248|NCT02774343|O2|Outcome|Placebo + Therapy + Contingency Management|"Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
11514|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
7219|NCT02777125|O2|Outcome|Albuterol Breath Actuated Nebulizer|"Subjects randomized to BAN were evaluated for proper breath actuation technique. For subjects unable to breath actuate, the RT changed the device setting to continuous nebulization, provided an appropriately sized mask, and returned upon completion of the treatment. Albuterol dosing was based upon the subject’s weight and presenting symptom severity. Children presenting in the mild and moderate severity category weighing less than 20kg, received 2500mcg of albuterol. Children weighing more than 20kg, received 2500mcg of albuterol if their presentation met mild severity criteria, or 5000mcg if they met moderate criteria.~Breath Actuated Nebulizer: The breath actuated nebulizer (BAN) device is a device that converts liquid medication, in this case albuterol, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be atta"
7220|NCT02777125|O1|Outcome|Albuterol by Metered Dose Inhaler|"Albuterol administered via MDI and spacer device with weight and severity based dosing. For weight less than 20 kg: mild and moderate disease 540mcg of albuterol per dose. For weight greater than or equal to 20 kg: mild disease 540 mcg of albuterol per dose and moderate disease 1080 mcg of albuterol per dose.~Metered Dose Inhaler: A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths."
7221|NCT02777125|O2|Outcome|Albuterol Breath Actuated Nebulizer|"Subjects randomized to BAN were evaluated for proper breath actuation technique. For subjects unable to breath actuate, the RT changed the device setting to continuous nebulization, provided an appropriately sized mask, and returned upon completion of the treatment. Albuterol dosing was based upon the subject’s weight and presenting symptom severity. Children presenting in the mild and moderate severity category weighing less than 20kg, received 2500mcg of albuterol. Children weighing more than 20kg, received 2500mcg of albuterol if their presentation met mild severity criteria, or 5000mcg if they met moderate criteria.~Breath Actuated Nebulizer: The breath actuated nebulizer (BAN) device is a device that converts liquid medication, in this case albuterol, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be atta"
7222|NCT02777125|O1|Outcome|Albuterol by Metered Dose Inhaler|"Albuterol administered via MDI and spacer device with weight and severity based dosing. For weight less than 20 kg: mild and moderate disease 540mcg of albuterol per dose. For weight greater than or equal to 20 kg: mild disease 540 mcg of albuterol per dose and moderate disease 1080 mcg of albuterol per dose.~Metered Dose Inhaler: A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths."
7223|NCT02777125|O2|Outcome|Albuterol Breath Actuated Nebulizer|"Subjects randomized to BAN were evaluated for proper breath actuation technique. The device settings were changed to provide continuous nebulization with a facemask if the patient could not breath actuate. Children presenting in the mild and moderate severity category weighing less than 20kg, received 2500mcg of albuterol. Children weighing more than 20kg, received 2500mcg of albuterol if their presentation met mild severity criteria, or 5000mcg if they met moderate criteria.~Breath Actuated Nebulizer: The breath actuated nebulizer (BAN) device is a device that converts liquid medication, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be attached to a mask and set to continuous nebulization for patients that are not able to coordinate their breaths."
7224|NCT02777125|O1|Outcome|Albuterol by Metered Dose Inhaler|"Albuterol administered via MDI and spacer device with weight and severity based dosing. For weight less than 20 kg: mild and moderate disease 540mcg of albuterol per dose. For weight greater than or equal to 20 kg: mild disease 540 mcg of albuterol per dose and moderate disease 1080 mcg of albuterol per dose.~Metered Dose Inhaler: A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths."
7225|NCT02777125|E2|Reported Event|Albuterol Breath Actuated Nebulizer|"Subjects randomized to BAN were evaluated for proper breath actuation technique. For subjects unable to breath actuate, the RT attached an appropriately sized mask to the device, changed the setting to continuous nebulization and returned upon completion of the treatment. Albuterol dosing was based upon the subject’s weight and presenting symptom severity. Children presenting in the mild and moderate severity category weighing less than 20kg, received 2500mcg of albuterol. Children weighing more than 20kg, received 2500mcg of albuterol if their presentation met mild severity criteria, or 5000mcg if they met moderate criteria.~Breath Actuated Nebulizer: The breath actuated nebulizer (BAN) device is a device that converts liquid medication, in this case albuterol, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be atta"
7226|NCT02777125|E1|Reported Event|Albuterol by Metered Dose Inhaler|"Albuterol administered via MDI and spacer device with weight and severity based dosing. For weight less than 20 kg: mild and moderate disease 540mcg of albuterol per dose. For weight greater than or equal to 20 kg: mild disease 540 mcg of albuterol per dose and moderate disease 1080 mcg of albuterol per dose.~Metered Dose Inhaler: A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths."
7227|NCT02774343|B3|Baseline|Total|Total of all reporting groups
7228|NCT02774343|B2|Baseline|Placebo + Therapy + Contingency Management|"Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7266|NCT02774278|B1|Baseline|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
7684|NCT02756624|O2|Outcome|AC-170 Vehicle|"1 drop in each eye 3 times daily for up to 6 weeks~AC-170 Vehicle"
7231|NCT02774343|P1|Participant Flow|Pioglitazone + Therapy + Contingency Management|"Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7232|NCT02774343|O2|Outcome|Placebo + Therapy + Contingency Management|"Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7233|NCT02774343|O1|Outcome|Pioglitazone + Therapy + Contingency Management|"Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7234|NCT02774343|O2|Outcome|Placebo + Therapy + Contingency Management|"Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7235|NCT02774343|O1|Outcome|Pioglitazone + Therapy + Contingency Management|"Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7236|NCT02774343|O2|Outcome|Placebo + Therapy + Contingency Management|"Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7237|NCT02774343|O1|Outcome|Pioglitazone + Therapy + Contingency Management|"Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7238|NCT02774343|O2|Outcome|Placebo + Therapy + Contingency Management|"Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7239|NCT02774343|O1|Outcome|Pioglitazone + Therapy + Contingency Management|"Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7240|NCT02774343|O2|Outcome|Placebo + Therapy + Contingency Management|"Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7241|NCT02774343|O1|Outcome|Pioglitazone + Therapy + Contingency Management|"Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7242|NCT02774343|O2|Outcome|Placebo + Therapy + Contingency Management|"Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7243|NCT02774343|O1|Outcome|Pioglitazone + Therapy + Contingency Management|"Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7244|NCT02774343|O2|Outcome|Placebo + Therapy + Contingency Management|"Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7245|NCT02774343|O1|Outcome|Pioglitazone + Therapy + Contingency Management|"Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7246|NCT02774343|O2|Outcome|Placebo + Therapy + Contingency Management|"Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7247|NCT02774343|O1|Outcome|Pioglitazone + Therapy + Contingency Management|"Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7685|NCT02756624|O1|Outcome|AC-170 0.24%|"1 drop in each eye 3 times daily for up to 6 weeks~AC-170 0.24%"
7249|NCT02774343|O1|Outcome|Pioglitazone + Therapy + Contingency Management|"Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7250|NCT02774343|O2|Outcome|Placebo + Therapy + Contingency Management|"Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7251|NCT02774343|O1|Outcome|Pioglitazone + Therapy + Contingency Management|"Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7252|NCT02774343|O2|Outcome|Placebo + Therapy + Contingency Management|"Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7253|NCT02774343|O1|Outcome|Pioglitazone + Therapy + Contingency Management|"Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7254|NCT02774343|O2|Outcome|Placebo + Therapy + Contingency Management|"Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7255|NCT02774343|O1|Outcome|Pioglitazone + Therapy + Contingency Management|"Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7256|NCT02774343|O2|Outcome|Placebo + Therapy + Contingency Management|"Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7257|NCT02774343|O1|Outcome|Pioglitazone + Therapy + Contingency Management|"Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7258|NCT02774343|O2|Outcome|Placebo + Therapy + Contingency Management|"Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7259|NCT02774343|O1|Outcome|Pioglitazone + Therapy + Contingency Management|"Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7260|NCT02774343|O2|Outcome|Placebo + Therapy + Contingency Management|"Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7261|NCT02774343|O1|Outcome|Pioglitazone + Therapy + Contingency Management|"Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7262|NCT02774343|O2|Outcome|Placebo + Therapy + Contingency Management|"Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7263|NCT02774343|O1|Outcome|Pioglitazone + Therapy + Contingency Management|"Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7264|NCT02774343|E2|Reported Event|Placebo + Therapy + Contingency Management|"Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
7265|NCT02774343|E1|Reported Event|Pioglitazone + Therapy + Contingency Management|"Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
11515|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
7268|NCT02774278|O1|Outcome|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
7269|NCT02774278|O1|Outcome|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
7270|NCT02774278|O1|Outcome|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
7271|NCT02774278|O1|Outcome|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
7272|NCT02774278|O1|Outcome|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
7273|NCT02774278|E1|Reported Event|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
7274|NCT02774148|B3|Baseline|Total|Total of all reporting groups
7275|NCT02774148|B2|Baseline|IV Acetaminophen|"1,000mg Acetaminophen IV every 8 hours until the patient has received 3 doses post-operatively. Then 1,000mg Acetaminophen po every 8 hours until discharge.~IV Acetaminophen: The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively."
7276|NCT02774148|B1|Baseline|PO Acetaminophen|"1,000mg Acetaminophen po every 8 hours until discharge.~PO Acetaminophen: The patient will receive 1,000mg po Acetaminophen every 8 hours."
7277|NCT02774148|P2|Participant Flow|IV Acetaminophen|"1,000mg Acetaminophen IV every 8 hours until the patient has received 3 doses post-operatively. Then 1,000mg Acetaminophen po every 8 hours until discharge.~IV Acetaminophen: The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively."
7278|NCT02774148|P1|Participant Flow|PO Acetaminophen|"1,000mg Acetaminophen po every 8 hours until discharge.~PO Acetaminophen: The patient will receive 1,000mg po Acetaminophen every 8 hours."
7279|NCT02774148|O2|Outcome|IV Acetaminophen|"1,000mg Acetaminophen IV every 8 hours until the patient has received 3 doses post-operatively. Then 1,000mg Acetaminophen po every 8 hours until discharge.~IV Acetaminophen: The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively."
7280|NCT02774148|O1|Outcome|PO Acetaminophen|"1,000mg Acetaminophen po every 8 hours until discharge.~PO Acetaminophen: The patient will receive 1,000mg po Acetaminophen every 8 hours."
7281|NCT02774148|O2|Outcome|IV Acetaminophen|"1,000mg Acetaminophen IV every 8 hours until the patient has received 3 doses post-operatively. Then 1,000mg Acetaminophen po every 8 hours until discharge.~IV Acetaminophen: The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively."
7282|NCT02774148|O1|Outcome|PO Acetaminophen|"1,000mg Acetaminophen po every 8 hours until discharge.~PO Acetaminophen: The patient will receive 1,000mg po Acetaminophen every 8 hours."
7283|NCT02774148|O2|Outcome|IV Acetaminophen|"1,000mg Acetaminophen IV every 8 hours until the patient has received 3 doses post-operatively. Then 1,000mg Acetaminophen po every 8 hours until discharge.~IV Acetaminophen: The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively."
7284|NCT02774148|O1|Outcome|PO Acetaminophen|"1,000mg Acetaminophen po every 8 hours until discharge.~PO Acetaminophen: The patient will receive 1,000mg po Acetaminophen every 8 hours."
7285|NCT02774148|O2|Outcome|IV Acetaminophen|"1,000mg Acetaminophen IV every 8 hours until the patient has received 3 doses post-operatively. Then 1,000mg Acetaminophen po every 8 hours until discharge.~IV Acetaminophen: The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively."
7286|NCT02774148|O1|Outcome|PO Acetaminophen|"1,000mg Acetaminophen po every 8 hours until discharge.~PO Acetaminophen: The patient will receive 1,000mg po Acetaminophen every 8 hours."
7287|NCT02774148|O2|Outcome|IV Acetaminophen|"1,000mg Acetaminophen IV every 8 hours until the patient has received 3 doses post-operatively. Then 1,000mg Acetaminophen po every 8 hours until discharge.~IV Acetaminophen: The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively."
7288|NCT02774148|O1|Outcome|PO Acetaminophen|"1,000mg Acetaminophen po every 8 hours until discharge.~PO Acetaminophen: The patient will receive 1,000mg po Acetaminophen every 8 hours."
7289|NCT02774148|E2|Reported Event|IV Acetaminophen|"1,000mg Acetaminophen IV every 8 hours until the patient has received 3 doses post-operatively. Then 1,000mg Acetaminophen po every 8 hours until discharge.~IV Acetaminophen: The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively."
7290|NCT02774148|E1|Reported Event|PO Acetaminophen|"1,000mg Acetaminophen po every 8 hours until discharge.~PO Acetaminophen: The patient will receive 1,000mg po Acetaminophen every 8 hours."
7291|NCT02773758|B3|Baseline|Total|Total of all reporting groups
7292|NCT02773758|B2|Baseline|Sodium Monofluorophosphate Dentifrice|Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush containing 0.76% sodium monofluorophosphate (1000ppm fluoride), and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
7293|NCT02773758|B1|Baseline|Stannous Fluoride Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride), then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
7294|NCT02773758|P2|Participant Flow|Sodium Monofluorophosphate Dentifrice|Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush containing 0.76% sodium monofluorophosphate (1000ppm fluoride), and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
7295|NCT02773758|P1|Participant Flow|Stannous Fluoride Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride), then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
7296|NCT02773758|O2|Outcome|Sodium Monofluorophosphate Dentifrice|Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
7297|NCT02773758|O1|Outcome|Stannous Fluoride Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
7298|NCT02773758|O2|Outcome|Sodium Monofluorophosphate Dentifrice|Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
7299|NCT02773758|O1|Outcome|Stannous Fluoride Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
7300|NCT02773758|O2|Outcome|Sodium Monofluorophosphate Dentifrice|Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
7301|NCT02773758|O1|Outcome|Stannous Fluoride Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
7302|NCT02773758|E2|Reported Event|Sodium Monofluorophosphate Dentifrice|Participants were instructed to topically apply a full brush head of toothpaste to a dry toothbrush, then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
7303|NCT02773758|E1|Reported Event|Stannous Fluoride Dentifrice|Participants were instructed to topically dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
7304|NCT02772666|B1|Baseline|All Study Participants|44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were enrolled.
7305|NCT02772666|P1|Participant Flow|All Study Participants|44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were enrolled.
7306|NCT02772666|O2|Outcome|Swinging Flashlight Test|44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were examined with manual swinging flashlight test(SFT).
7307|NCT02772666|O1|Outcome|O-Glass|44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were examined with O-Glass.
7308|NCT02772666|E1|Reported Event|All Study Participants|This diagnostic intervention is just an inspection and taking picture of the eye.
7309|NCT02770625|B1|Baseline|ISU302|"60 U/kg (once every 2 weeks for 6 months)~ISU302: 60 U/kg given intravenously"
7310|NCT02770625|P1|Participant Flow|ISU302|"60 U/kg (once every 2 weeks for 6 months)~ISU302: 60 U/kg given intravenously"
7311|NCT02770625|O1|Outcome|ISU302|"60 U/kg (once every 2 weeks for 6 months)~ISU302: 60 U/kg given intravenously"
7312|NCT02770625|O1|Outcome|ISU302|"60 U/kg (once every 2 weeks for 6 months)~ISU302: 60 U/kg given intravenously"
7313|NCT02770625|O1|Outcome|ISU302|"60 U/kg (once every 2 weeks for 6 months)~ISU302: 60 U/kg given intravenously"
7314|NCT02770625|O1|Outcome|ISU302|"60 U/kg (once every 2 weeks for 6 months)~ISU302: 60 U/kg given intravenously"
7315|NCT02770625|O1|Outcome|ISU302|"60 U/kg (once every 2 weeks for 6 months)~ISU302: 60 U/kg given intravenously"
7316|NCT02770625|O1|Outcome|ISU302|"60 U/kg (once every 2 weeks for 6 months)~ISU302: 60 U/kg given intravenously"
7317|NCT02770625|O1|Outcome|ISU302|"60 U/kg (once every 2 weeks for 6 months)~ISU302: 60 U/kg given intravenously"
7318|NCT02770625|O1|Outcome|ISU302|"60 U/kg (once every 2 weeks for 6 months)~ISU302: 60 U/kg given intravenously"
7319|NCT02770625|O1|Outcome|ISU302|"60 U/kg (once every 2 weeks for 6 months)~ISU302: 60 U/kg given intravenously"
7320|NCT02770625|O1|Outcome|ISU302|"60 U/kg (once every 2 weeks for 6 months)~ISU302: 60 U/kg given intravenously"
7321|NCT02770625|E1|Reported Event|ISU302|"60 U/kg (once every 2 weeks for 6 months)~ISU302: 60 U/kg given intravenously"
7322|NCT02770248|B3|Baseline|Total|Total of all reporting groups
7323|NCT02770248|B2|Baseline|Vehicle|Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
7324|NCT02770248|B1|Baseline|SIMBRINZA|Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
7325|NCT02770248|P2|Participant Flow|Vehicle|Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
7326|NCT02770248|P1|Participant Flow|SIMBRINZA|Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
7327|NCT02770248|O2|Outcome|Vehicle|Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
7328|NCT02770248|O1|Outcome|SIMBRINZA|Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
7329|NCT02770248|O2|Outcome|Vehicle|Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
7330|NCT02770248|O1|Outcome|SIMBRINZA|Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
7331|NCT02770248|O2|Outcome|Vehicle|Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
7332|NCT02770248|O1|Outcome|SIMBRINZA|Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
7333|NCT02770248|O2|Outcome|Vehicle|Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
7334|NCT02770248|O1|Outcome|SIMBRINZA|Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
7335|NCT02770248|E2|Reported Event|Vehicle|All subjects exposed to Vehicle
7336|NCT02770248|E1|Reported Event|SIMBRINZA|All subjects exposed to SIMBRINZA
7337|NCT02769858|B1|Baseline|Light Therapy|"Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks.~Light therapy: Light therapy glasses"
11516|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
7338|NCT02769858|P1|Participant Flow|Light Therapy|"Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks.~Light therapy: Light therapy glasses"
7339|NCT02769858|O1|Outcome|Light Therapy|"Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks.~Light therapy: Light therapy glasses"
7340|NCT02769858|O1|Outcome|Light Therapy|"Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks.~Light therapy: Light therapy glasses"
7341|NCT02769858|O1|Outcome|Light Therapy|"Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks.~Light therapy: Light therapy glasses"
7342|NCT02769858|E1|Reported Event|Light Therapy|"Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks.~Light therapy: Light therapy glasses"
7343|NCT02768194|B1|Baseline|All Randomized Participants|All randomized participants were included for baseline evaluation.
7344|NCT02768194|P6|Participant Flow|Reference/Negative Control/Test|Firstly, participants received reference dentifrice, secondly negative control and thirdly test dentrifrice. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant’s mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant’s appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant’s mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
7345|NCT02768194|P5|Participant Flow|Reference/Test/Negative Control|Firstly, participants received reference dentifrice, secondly test dentifrice and thirdly negative control. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant’s mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant’s appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant’s mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
7346|NCT02768194|P4|Participant Flow|Negative Control/Reference/Test|Firstly, participants received negative control, secondly reference dentifrice and thirdly test dentifrice. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant’s mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant’s appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant’s mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
7347|NCT02768194|P3|Participant Flow|Negative Control/Test/Reference|Firstly, participants received negative control, secondly test dentifrice and thirdly reference dentifrice. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant’s mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant’s appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant’s mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
7348|NCT02768194|P2|Participant Flow|Test/Reference/Negative Control|Firstly, participants received test dentifrice, secondly reference dentifrice and thirdly negative control. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant’s mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant’s appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant’s mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
7349|NCT02768194|P1|Participant Flow|Test /Negative Control/Reference|Firstly, participants received dentifrice containing 0.454% stannous fluoride (test), secondly mineral water (negative control) and thirdly dentifrice containing 0.76% sodium monofluorophosphate (reference). Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant’s mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant’s appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant’s mouth and the participants rinsed with 10 milliliters (mL) of mineral water for 5 seconds.
7350|NCT02768194|O3|Outcome|Negative Control|Participants used commercially available mineral water. Appliances brushed ex situ in mineral water twice daily were then returned to the participant’s mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant’s appliances) using an electric toothbrush in mineral water. Appliances were returned to the participant’s mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
7351|NCT02768194|O2|Outcome|Reference Product|Participants used dentifrice containing 0.76% sodium monofluorophosphate. Appliances brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant’s mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant’s appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant’s mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
7352|NCT02768194|O1|Outcome|Test Product|Participants used dentifrice containing 0.454% stannous fluoride. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant’s mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant’s appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant’s mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
7353|NCT02768194|O3|Outcome|Negative Control|Participants used commercially available mineral water. Appliances brushed ex situ in mineral water twice daily were then returned to the participant’s mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant’s appliances) using an electric toothbrush in mineral water. Appliances were returned to the participant’s mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
7354|NCT02768194|O2|Outcome|Reference Product|Participants used dentifrice containing 0.76% sodium monofluorophosphate. Appliances brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant’s mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant’s appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant’s mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
11517|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
7355|NCT02768194|O1|Outcome|Test Product|Participants used dentifrice containing 0.454% stannous fluoride. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant’s mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant’s appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant’s mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
7356|NCT02768194|E3|Reported Event|Negative Control|Participants used commercially available mineral water. Appliances brushed ex situ in mineral water twice daily were then returned to the participant’s mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant’s appliances) using an electric toothbrush in mineral water. Appliances were returned to the participant’s mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
7357|NCT02768194|E2|Reported Event|Reference Product|Participants used dentifrice containing 0.76% sodium monofluorophosphate. Appliances brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant’s mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant’s appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant’s mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
7358|NCT02768194|E1|Reported Event|Test Product|Participants used dentifrice containing 0.454% stannous fluoride. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant’s mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant’s appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant’s mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
7359|NCT02767843|B1|Baseline|Treatment|"continuous negative external pressure (cNEP) at various negative pressures~continuous negative external pressure (cNEP): soft silicone collar placed on the anterior neck, to which a negative pressure is introduced"
7360|NCT02767843|P1|Participant Flow|Subjects|Only four subjects completed the study.
7361|NCT02767843|O1|Outcome|Subjects|Only four subjects were entered into the study. No efficacy data could be analyzed because of technical problems with the data collection equipment.
7362|NCT02767843|O1|Outcome|Subjects|Only four subjects were entered into the study.
7363|NCT02767843|O1|Outcome|Subjects|Only four subjects were entered into the study. None had outcome measure (2) collected because of technical problems with data collection. Thus no interpretable data were collected.
7364|NCT02767843|E1|Reported Event|All Subjects|Only four subjects completed the study.
7365|NCT02767765|B1|Baseline|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
7366|NCT02767765|P1|Participant Flow|Recombinant Human Erythropoietin Beta (r-HuEPO)|Anemic cancer participants received r-HuEPO (NeoRecormon) as subcutaneous (SC) or intramuscular (IM) injection for 4 weeks, at a dose of 10000 international units per day (IU/day) according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
7367|NCT02767765|O1|Outcome|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
7368|NCT02767765|O1|Outcome|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
7369|NCT02767765|O1|Outcome|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
7370|NCT02767765|O1|Outcome|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
7371|NCT02767765|O1|Outcome|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
7372|NCT02767765|O1|Outcome|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
7373|NCT02767765|E1|Reported Event|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
7374|NCT02766400|B3|Baseline|Total|Total of all reporting groups
7387|NCT02766283|O1|Outcome|Probable Iodine-induced Hypothyroidism|Included all potential cases of hypothyroidism with no other cause than the previous ICM exposure could be identified.
11518|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
7375|NCT02766400|B2|Baseline|Directed Training|"Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.~Directed Training"
7376|NCT02766400|B1|Baseline|Guided Training|"Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with practical skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.~Guided Training"
7377|NCT02766400|P2|Participant Flow|Directed Training|"Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.~Directed Training"
7378|NCT02766400|P1|Participant Flow|Guided Training|"Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with practical skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.~Guided Training"
7379|NCT02766400|O2|Outcome|Directed Training|"Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.~Directed Training"
7380|NCT02766400|O1|Outcome|Guided Training|"Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with practical skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.~Guided Training"
7381|NCT02766400|E2|Reported Event|Directed Training|"Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.~Directed Training"
7382|NCT02766400|E1|Reported Event|Guided Training|"Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with practical skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.~Guided Training"
7383|NCT02766283|B1|Baseline|Iodine Contrast Agent|The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: TSH levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy.
7384|NCT02766283|P1|Participant Flow|Iodine Contrast Agent|The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: thyroid-stimulating hormone (TSH) levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy.
7385|NCT02766283|O1|Outcome|Probable Iodine-induced Hypothyroidism|Included all potential cases of hypothyroidism with no other cause than the previous ICM exposure could be identified.
7386|NCT02766283|O1|Outcome|Probable Iodine-induced Hypothyroidism|Included all potential cases of hypothyroidism with no other cause than the previous ICM exposure could be identified.
7581|NCT02759692|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A lens during any of the three study periods.
7388|NCT02766283|O1|Outcome|Final Cohort|Participants without potential hypothyroidism detected during the one-year follow up period (828 person years)
7389|NCT02766283|O2|Outcome|Hypothyroidism Indication|Participants with potential hypothyroidism detected during the one-year follow up period (828 person years)
7390|NCT02766283|O1|Outcome|No Hypothyroidism Indication|Participants without potential hypothyroidism detected during the one-year follow up period (828 person years)
7391|NCT02766283|O2|Outcome|Hypothyroidism Indication|Participants with potential hypothyroidism detected during the one-year follow up period (828 person years)
7392|NCT02766283|O1|Outcome|No Hypothyroidism Indication|Participants without potential hypothyroidism detected during the one-year follow up period (828 person years)
7393|NCT02766283|O2|Outcome|Hypothyroidism Indication|Participants with potential hypothyroidism detected during the one-year follow up period (828 person years)
7394|NCT02766283|O1|Outcome|No Hypothyroidism Indication|Participants without potential hypothyroidism detected during the one-year follow up period (828 person years)
7395|NCT02766283|O2|Outcome|Hypothyroidism Indication|Participants with potential hypothyroidism detected during the one-year follow up period (828 person years)
7396|NCT02766283|O1|Outcome|No Hypothyroidism Indication|Participants without potential hypothyroidism detected during the one-year follow up period (828 person years)
7397|NCT02766283|O2|Outcome|Hypothyroidism Indication|Participants with potential hypothyroidism detected during the one-year follow up period (828 person years)
7398|NCT02766283|O1|Outcome|No Hypothyroidism Indication|Participants without potential hypothyroidism detected during the one-year follow up period (828 person years)
7399|NCT02766283|O2|Outcome|Hypothyroidism Indication|Participants with potential hypothyroidism detected during the one-year follow up period (828 person years)
7400|NCT02766283|O1|Outcome|No Hypothyroidism Indication|Participants without potential hypothyroidism detected during the one-year follow up period (828 person years)
7401|NCT02766283|O2|Outcome|Hypothyroidism Indication|Participants with potential hypothyroidism detected during the one-year follow up period (828 person years)
7402|NCT02766283|O1|Outcome|No Hypothyroidism Indication|Participants without potential hypothyroidism detected during the one-year follow up period (828 person years)
7403|NCT02766283|O2|Outcome|Hypothyroidism Indication|Participants with potential hypothyroidism detected during the one-year follow up period (828 person years)
7404|NCT02766283|O1|Outcome|No Hypothyroidism Indication|Participants without potential hypothyroidism detected during the one-year follow up period (828 person years)
7405|NCT02766283|O1|Outcome|Iodine Contrast Agent|The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: TSH levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy.
7406|NCT02766283|E1|Reported Event|Iodine Contrast Agent|The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: TSH levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy.
7407|NCT02766244|B1|Baseline|ICG/SPY|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
7408|NCT02766244|P1|Participant Flow|ICG/SPY|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
7409|NCT02766244|O6|Outcome|Patient 3 Deep Tissue|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
7410|NCT02766244|O5|Outcome|Patient 3 Superficial|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
7411|NCT02766244|O4|Outcome|Patient 2 Deep Tissue|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
7412|NCT02766244|O3|Outcome|Patient 2 Superficial|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
7413|NCT02766244|O2|Outcome|Patient 1 Deep Tissue|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
7414|NCT02766244|O1|Outcome|Patient 1 Superficial|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
7415|NCT02766244|E1|Reported Event|ICG/SPY|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
7416|NCT02765269|B3|Baseline|Total|Total of all reporting groups
7417|NCT02765269|B2|Baseline|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
7418|NCT02765269|B1|Baseline|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.~Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
7419|NCT02765269|P2|Participant Flow|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
7420|NCT02765269|P1|Participant Flow|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.~Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
7421|NCT02765269|O2|Outcome|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
7422|NCT02765269|O1|Outcome|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.~Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
7423|NCT02765269|O2|Outcome|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
7424|NCT02765269|O1|Outcome|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.~Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
7425|NCT02765269|O2|Outcome|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
7426|NCT02765269|O1|Outcome|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.~Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
7427|NCT02765269|O2|Outcome|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
7428|NCT02765269|O1|Outcome|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.~Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
7429|NCT02765269|E2|Reported Event|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
7430|NCT02765269|E1|Reported Event|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.~Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
7431|NCT02764970|B3|Baseline|Total|Total of all reporting groups
7432|NCT02764970|B2|Baseline|Bisoprolol|patients are only pretreated with bisoprolol orally before Cardiac CT angiogram
7433|NCT02764970|B1|Baseline|Ivabradine 7.5mg Orally|"patients are pretreated with ivabradine and bisoprolol orally before Cardiac CT angiogram~Ivabradine 7.5mg orally: additive use to the standard medication with bisoprolol"
7434|NCT02764970|P2|Participant Flow|Bisoprolol|patients are only pretreated with bisoprolol orally before Cardiac CT angiogram
7435|NCT02764970|P1|Participant Flow|Ivabradine 7.5mg Orally|"patients are pretreated with ivabradine and bisoprolol orally before Cardiac CT angiogram~Ivabradine 7.5mg orally: additive use to the standard medication with bisoprolol"
7436|NCT02764970|O2|Outcome|Bisoprolol|patients are only pretreated with bisoprolol orally before Cardiac CT angiogram
7437|NCT02764970|O1|Outcome|Ivabradine 7.5mg Orally|"patients are pretreated with ivabradine and bisoprolol orally before Cardiac CT angiogram~Ivabradine 7.5mg orally: additive use to the standard medication with bisoprolol"
7438|NCT02764970|O2|Outcome|Bisoprolol|patients are only pretreated with bisoprolol orally before Cardiac CT angiogram
7439|NCT02764970|O1|Outcome|Ivabradine 7.5mg Orally|"patients are pretreated with ivabradine and bisoprolol orally before Cardiac CT angiogram~Ivabradine 7.5mg orally: additive use to the standard medication with bisoprolol"
7440|NCT02764970|O2|Outcome|Bisoprolol|patients are only pretreated with bisoprolol orally before Cardiac CT angiogram
7441|NCT02764970|O1|Outcome|Ivabradine 7.5mg Orally|"patients are pretreated with ivabradine and bisoprolol orally before Cardiac CT angiogram~Ivabradine 7.5mg orally: additive use to the standard medication with bisoprolol"
7442|NCT02764970|O2|Outcome|Bisoprolol|patients are only pretreated with bisoprolol orally before Cardiac CT angiogram
7443|NCT02764970|O1|Outcome|Ivabradine 7.5mg Orally|"patients are pretreated with ivabradine and bisoprolol orally before Cardiac CT angiogram~Ivabradine 7.5mg orally: additive use to the standard medication with bisoprolol"
7444|NCT02764970|E2|Reported Event|Bisoprolol|patients are only pretreated with bisoprolol orally before Cardiac CT angiogram
7445|NCT02764970|E1|Reported Event|Ivabradine 7.5mg Orally|"patients are pretreated with ivabradine and bisoprolol orally before Cardiac CT angiogram~Ivabradine 7.5mg orally: additive use to the standard medication with bisoprolol"
7446|NCT02763189|B3|Baseline|Total|Total of all reporting groups
7447|NCT02763189|B2|Baseline|Mentored|"Mentored group will study the learning materials and then receive expert mentoring~Expert mentoring: Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.~Self-study: All subjects will receive self-study"
7582|NCT02759692|O2|Outcome|Stenfilcon A|Subjects that received the stenfilcon A lens during any three of the study periods.
7448|NCT02763189|B1|Baseline|Control|"Control group will study the learning material independently. 'Self-study'.~Self-study: All subjects will receive self-study"
7449|NCT02763189|P2|Participant Flow|Mentored|"Mentored group will study the learning materials and then receive expert mentoring~Expert mentoring: Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.~Self-study: All subjects will receive self-study"
7450|NCT02763189|P1|Participant Flow|Control|"Control group will study the learning material independently. 'Self-study'.~Self-study: All subjects will receive self-study"
7451|NCT02763189|O2|Outcome|Mentored|"Mentored group will study the learning materials and then receive expert mentoring~Expert mentoring: Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.~Self-study: All subjects will receive self-study"
7452|NCT02763189|O1|Outcome|Control|"Control group will study the learning material independently. 'Self-study'.~Self-study: All subjects will receive self-study"
7453|NCT02763189|O2|Outcome|Mentored|"Mentored group will study the learning materials and then receive expert mentoring~Expert mentoring: Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.~Self-study: All subjects will receive self-study"
7454|NCT02763189|O1|Outcome|Control|"Control group will study the learning material independently. 'Self-study'.~Self-study: All subjects will receive self-study"
7455|NCT02763189|E2|Reported Event|Mentored|"Mentored group will study the learning materials and then receive expert mentoring~Expert mentoring: Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.~Self-study: All subjects will receive self-study"
7456|NCT02763189|E1|Reported Event|Control|"Control group will study the learning material independently. 'Self-study'.~Self-study: All subjects will receive self-study"
7457|NCT02762370|B3|Baseline|Total|Total of all reporting groups
7458|NCT02762370|B2|Baseline|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
7459|NCT02762370|B1|Baseline|FX006 32 mg|FX006: Single 5 mL IA injection
7460|NCT02762370|P2|Participant Flow|TCA IR 40 mg|15 subjects received triamcinolone acetonide injectable suspension, immediate release (TCA IR) 40 mg as a single 1 mL IA injection
7461|NCT02762370|P1|Participant Flow|FX006 32 mg|18 subjects received FX006 32 mg as a single 5 mL intra-articular (IA) injection
7462|NCT02762370|O2|Outcome|TCA IR 40 mg|Single 1 mL IA injection
7463|NCT02762370|O1|Outcome|FX006 32 mg|Single 5 mL IA injection
7464|NCT02762370|O2|Outcome|TCA IR 40 mg|Single 1 mL IA injection
7465|NCT02762370|O1|Outcome|FX006 32 mg|Single 5 mL IA injection
7466|NCT02762370|O2|Outcome|TCA IR 40 mg|Single 1 mL IA injection
7467|NCT02762370|O1|Outcome|FX006 32 mg|Single 5 mL IA injection
7468|NCT02762370|O2|Outcome|TCA IR 40 mg|Single 1 mL IA injection
7469|NCT02762370|O1|Outcome|FX006 32 mg|Single 5 mL IA injection
7470|NCT02762370|O2|Outcome|TCA IR 40 mg|Single 1 mL IA injection
7471|NCT02762370|O1|Outcome|FX006 32 mg|Single 5 mL IA injection
7472|NCT02762370|O2|Outcome|TCA IR 40 mg|Single 1 mL IA injection
7473|NCT02762370|O1|Outcome|FX006 32 mg|Single 5 mL IA injection
7474|NCT02762370|O2|Outcome|TCA IR 40 mg|"Drug: TCA IR Single intra-articular injection~TCA IR 40 mg"
7475|NCT02762370|O1|Outcome|FX006 32 mg|"Drug: FX006 Single intra-articular injection~FX006 32 mg"
7476|NCT02762370|E2|Reported Event|TCA IR 40 mg|"Drug: TCA IR Single intra-articular injection~TCA IR 40 mg"
7477|NCT02762370|E1|Reported Event|FX006 32 mg|"Drug: FX006 Single intra-articular injection~FX006 32 mg"
7478|NCT02761733|B5|Baseline|Total|Total of all reporting groups
7479|NCT02761733|B4|Baseline|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
7480|NCT02761733|B3|Baseline|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
7481|NCT02761733|B2|Baseline|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
7482|NCT02761733|B1|Baseline|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
7483|NCT02761733|P4|Participant Flow|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
7484|NCT02761733|P3|Participant Flow|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
7485|NCT02761733|P2|Participant Flow|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
7486|NCT02761733|P1|Participant Flow|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
7487|NCT02761733|O4|Outcome|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
7488|NCT02761733|O3|Outcome|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
7489|NCT02761733|O2|Outcome|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
7490|NCT02761733|O1|Outcome|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
7491|NCT02761733|O4|Outcome|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
7492|NCT02761733|O3|Outcome|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
7493|NCT02761733|O2|Outcome|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
7494|NCT02761733|O1|Outcome|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
7495|NCT02761733|O4|Outcome|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
7496|NCT02761733|O3|Outcome|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
7497|NCT02761733|O2|Outcome|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
7498|NCT02761733|O1|Outcome|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
7499|NCT02761733|O4|Outcome|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
7500|NCT02761733|O3|Outcome|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
7501|NCT02761733|O2|Outcome|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
7502|NCT02761733|O1|Outcome|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
7503|NCT02761733|O4|Outcome|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
7504|NCT02761733|O3|Outcome|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
7505|NCT02761733|O2|Outcome|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
7506|NCT02761733|O1|Outcome|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
7507|NCT02761733|O4|Outcome|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
7508|NCT02761733|O3|Outcome|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
7509|NCT02761733|O2|Outcome|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
7510|NCT02761733|O1|Outcome|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
7511|NCT02761733|E4|Reported Event|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
7512|NCT02761733|E3|Reported Event|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
7513|NCT02761733|E2|Reported Event|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
7514|NCT02761733|E1|Reported Event|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
7515|NCT02761629|B3|Baseline|Total|Total of all reporting groups
7516|NCT02761629|B2|Baseline|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
7517|NCT02761629|B1|Baseline|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
7518|NCT02761629|P2|Participant Flow|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
7519|NCT02761629|P1|Participant Flow|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received peg-interferon alpha-2A (Peg-IFN-Alpha-2A) and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 micrograms (mcg) once weekly via subcutaneous injection. Ribavirin was administered as either 1000 milligrams (mg) per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing less than (<) 75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing greater than or equal to (>/=) 75 kg.
7520|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
7521|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
7522|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
7523|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
7524|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
7525|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
7526|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
7527|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
7528|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
7529|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
7530|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
7531|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
7532|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
7533|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
7534|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
7535|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
7536|NCT02761629|E2|Reported Event|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
7583|NCT02759692|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A lens during any of the three study periods.
7537|NCT02761629|E1|Reported Event|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
7538|NCT02760810|B1|Baseline|Narafilcon A|All subjects wore the same lens throughout the study.
7539|NCT02760810|P1|Participant Flow|Narafilcon A|All subjects wore the same lens throughout the study.
7540|NCT02760810|O1|Outcome|Narafilcon A|All subjects wore the same lens throughout the study.
7541|NCT02760810|O1|Outcome|Narafilcon A|All subjects wore the same lens throughout the study.
7542|NCT02760810|O1|Outcome|Narafilcon A|All subjects wore the same lens throughout the study.
7543|NCT02760810|E1|Reported Event|Narafilcon A|All subjects wore the same lens throughout the study.
7544|NCT02760654|B3|Baseline|Total|Total of all reporting groups
7545|NCT02760654|B2|Baseline|Control|Treatment as usual
7546|NCT02760654|B1|Baseline|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
7547|NCT02760654|P2|Participant Flow|Control|Treatment as usual
7548|NCT02760654|P1|Participant Flow|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
7549|NCT02760654|O2|Outcome|Control|Treatment as usual
7550|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
7551|NCT02760654|O2|Outcome|Control|Treatment as usual
7552|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
7553|NCT02760654|O2|Outcome|Control|Treatment as usual
7554|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
7555|NCT02760654|O2|Outcome|Control|Treatment as usual
7556|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
7557|NCT02760654|O2|Outcome|Control|Treatment as usual
7558|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
7559|NCT02760654|O2|Outcome|Control|Treatment as usual
7560|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
7561|NCT02760654|O2|Outcome|Control|Treatment as usual
7562|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
7563|NCT02760654|O2|Outcome|Control|Treatment as usual
7564|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
7565|NCT02760654|O2|Outcome|Control|Treatment as usual
7566|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
7567|NCT02760654|O2|Outcome|Control|Treatment as usual
7568|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
7569|NCT02760654|E2|Reported Event|Control|Treatment as usual
7570|NCT02760654|E1|Reported Event|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
7571|NCT02759692|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens.
7572|NCT02759692|P2|Participant Flow|Stenfilcon A/ Senofilcon A/ Stenfilcon A|subjects randomized to this sequence received the stenfilcon A lens during the first period, the senofilcon A lens during the second period and the stenfilcon A lens during the third period.
7573|NCT02759692|P1|Participant Flow|Senofilcon A/ Stenfilcon A/ Senofilcon A|Subjects randomized to this sequence received the senofilcon A lens during the first period, the stenfilcon A lens during the second period and the senofilcon A lens during the third period.
7574|NCT02759692|O2|Outcome|Stenfilcon A|Subjects that received the stenfilcon A lens during any three of the study periods.
7575|NCT02759692|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A lens during any of the three study periods.
7576|NCT02759692|O2|Outcome|Stenfilcon A|Subjects that received the stenfilcon A lens during any three of the study periods.
7577|NCT02759692|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A lens during any of the three study periods.
7578|NCT02759692|O2|Outcome|Stenfilcon A|Subjects that received the stenfilcon A lens during any three of the study periods.
7579|NCT02759692|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A lens during any of the three study periods.
7580|NCT02759692|O2|Outcome|Stenfilcon A|Subjects that received the stenfilcon A lens during any three of the study periods.
7588|NCT02759471|B1|Baseline|Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test)|"Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test).~comfilcon A sphere lens (control): contact lens~comfilcon A asphere lens (test): contact lens"
7589|NCT02759471|P1|Participant Flow|Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test)|"Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test).~comfilcon A sphere lens (control): contact lens~comfilcon A asphere lens (test): contact lens"
7590|NCT02759471|O1|Outcome|Investigator Rating of Fit Preference|habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
7591|NCT02759471|O2|Outcome|Comfilcon A Asphere (Test)|habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
7592|NCT02759471|O1|Outcome|Comfilcon A Sphere (Control)|habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
7593|NCT02759471|O2|Outcome|Comfilcon A Asphere (Test)|habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
7594|NCT02759471|O1|Outcome|Comfilcon A Sphere (Control)|habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
7595|NCT02759471|O2|Outcome|Comfilcon A Asphere (Test)|habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
7596|NCT02759471|O1|Outcome|Comfilcon A Sphere (Control)|habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
7597|NCT02759471|E1|Reported Event|Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test)|"Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test).~comfilcon A sphere lens (control): contact lens~comfilcon A asphere lens (test): contact lens"
7598|NCT02758613|B5|Baseline|Total|Total of all reporting groups
7599|NCT02758613|B4|Baseline|10mg Baricitinib|10mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
7600|NCT02758613|B3|Baseline|4mg Baricitinib|4mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
7601|NCT02758613|B2|Baseline|2mg Baricitinib|2mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
7602|NCT02758613|B1|Baseline|Placebo|Placebo matching baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
7603|NCT02758613|P4|Participant Flow|10mg Baricitinib|10mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
7604|NCT02758613|P3|Participant Flow|4mg Baricitinib|4mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
7605|NCT02758613|P2|Participant Flow|2mg Baricitinib|2mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
7606|NCT02758613|P1|Participant Flow|Placebo|Placebo matching baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
7607|NCT02758613|O3|Outcome|10mg Baricitinib|10mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
7608|NCT02758613|O2|Outcome|4mg Baricitinib|4mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
7609|NCT02758613|O1|Outcome|2mg Baricitinib|2mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
7610|NCT02758613|O3|Outcome|10mg Baricitinib|10mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
7611|NCT02758613|O2|Outcome|4mg Baricitinib|4mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
7612|NCT02758613|O1|Outcome|2mg Baricitinib|2mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
7613|NCT02758613|O4|Outcome|10mg Baricitinib|10mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
7614|NCT02758613|O3|Outcome|4mg Baricitinib|4mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
7615|NCT02758613|O2|Outcome|2mg Baricitinib|2mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
7616|NCT02758613|O1|Outcome|Placebo|Placebo matching baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
7617|NCT02758613|E4|Reported Event|10mg Baricitinib|10mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
7618|NCT02758613|E3|Reported Event|4mg Baricitinib|4mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
7619|NCT02758613|E2|Reported Event|2mg Baricitinib|2mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
7620|NCT02758613|E1|Reported Event|Placebo|Placebo matching baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
7621|NCT02758210|B1|Baseline|Participants With MICRA Device|Participants that received the MICRA device prior to study enrollment and who consented to having monitored use of a smart phone and a tablet at a single study visit.
7622|NCT02758210|P1|Participant Flow|Participants With MICRA Device|Participants that received the MICRA device prior to study enrollment and who consented to having monitored use of a smart phone and a tablet at a single study visit.
7623|NCT02758210|O1|Outcome|Participants With MICRA Device|Participants that received the MICRA device prior to study enrollment and who consented to having monitored use of a smart phone and a tablet at a single study visit.
7624|NCT02758210|O1|Outcome|Participants With MICRA Device|Participants that received the MICRA device prior to study enrollment and who consented to having monitored use of a smart phone and a tablet at a single study visit.
7625|NCT02758210|O1|Outcome|Participants With MICRA Device|Participants that received the MICRA device prior to study enrollment and who consented to having monitored use of a smart phone and a tablet at a single study visit.
7626|NCT02758210|O1|Outcome|Participants With MICRA Device|Participants that received the MICRA device prior to study enrollment and who consented to having monitored use of a smart phone and a tablet at a single study visit.
7627|NCT02758210|O1|Outcome|Participants With MICRA Device|Participants that received the MICRA device prior to study enrollment and who consented to having monitored use of a smart phone and a tablet at a single study visit.
7628|NCT02758210|O1|Outcome|Participants With MICRA Device|Participants that received the MICRA device prior to study enrollment and who consented to having monitored use of a smart phone and a tablet at a single study visit.
7629|NCT02758210|E1|Reported Event|Participants With MICRA Device|Participants that received the MICRA device prior to study enrollment and who consented to having monitored use of a smart phone and a tablet at a single study visit.
7630|NCT02758171|B3|Baseline|Total|Total of all reporting groups
7631|NCT02758171|B2|Baseline|Empagliflozin+Linagliptin/FDC|"The subjects were administered one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R) in period 1, followed by one FDC film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin administered orally with 240 mL of water after an overnight fast of at least 10 h, as a single dose in the fasted state on Day 1 of Test treatment (T) in period 2.~A wash-out period of at least 35 days was set following the drug administration in each period."
7632|NCT02758171|B1|Baseline|FDC/Empagliflozin+Linagliptin|"The subjects were administered one FDC (Fixed-Dose Combination) film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin orally with 240 mL of water after an overnight fast of at least 10 hours (h), as a single dose in the fasted state on Day 1 of Test treatment (T) in period 1, followed by one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) administered orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R) in period 2.~A wash-out period of at least 35 days was set following the drug administration in each period."
7633|NCT02758171|P2|Participant Flow|Empagliflozin+Linagliptin/FDC|"The subjects were administered one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R) in period 1, followed by one FDC film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin administered orally with 240 mL of water after an overnight fast of at least 10 h, as a single dose in the fasted state on Day 1 of Test treatment (T) in period 2.~A wash-out period of at least 35 days was set following the drug administration in each period."
7634|NCT02758171|P1|Participant Flow|FDC/Empagliflozin+Linagliptin|"The subjects were administered one FDC (Fixed-Dose Combination) film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin orally with 240 mL of water after an overnight fast of at least 10 hours (h), as a single dose in the fasted state on Day 1 of Test treatment (T) in period 1, followed by one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) administered orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R) in period 2.~A wash-out period of at least 35 days was set following the drug administration in each period."
7635|NCT02758171|O2|Outcome|Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets|The subjects were administered one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R).
7636|NCT02758171|O1|Outcome|FDC (10 mg Empagliflozin and 5 mg Linagliptin)|The subjects were administered one FDC film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin orally with 240 mL of water after an overnight fast of at least 10 hours (h), as a single dose in the fasted state on Day 1 of Test treatment (T).
7637|NCT02758171|O2|Outcome|Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets|The subjects were administered one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R).
7638|NCT02758171|O1|Outcome|FDC (10 mg Empagliflozin and 5 mg Linagliptin)|The subjects were administered one FDC film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin orally with 240 mL of water after an overnight fast of at least 10 hours (h), as a single dose in the fasted state on Day 1 of Test treatment (T).
7639|NCT02758171|O2|Outcome|Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets|The subjects were administered one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R).
7640|NCT02758171|O1|Outcome|FDC (10 mg Empagliflozin and 5 mg Linagliptin)|The subjects were administered one FDC film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin orally with 240 mL of water after an overnight fast of at least 10 hours (h), as a single dose in the fasted state on Day 1 of Test treatment (T).
7641|NCT02758171|O2|Outcome|Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets|The subjects were administered one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R).
7642|NCT02758171|O1|Outcome|FDC (10 mg Empagliflozin and 5 mg Linagliptin)|The subjects were administered one FDC film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin orally with 240 mL of water after an overnight fast of at least 10 hours (h), as a single dose in the fasted state on Day 1 of Test treatment (T).
7643|NCT02758171|O2|Outcome|Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets|The subjects were administered one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R).
7644|NCT02758171|O1|Outcome|FDC (10 mg Empagliflozin and 5 mg Linagliptin)|The subjects were administered one FDC film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin orally with 240 mL of water after an overnight fast of at least 10 hours (h), as a single dose in the fasted state on Day 1 of Test treatment (T).
7686|NCT02756624|E2|Reported Event|AC-170 Vehicle|"1 drop in each eye 3 times daily for up to 6 weeks~AC-170 Vehicle"
7687|NCT02756624|E1|Reported Event|AC-170 0.24%|"1 drop in each eye 3 times daily for up to 6 weeks~AC-170 0.24%"
7688|NCT02756351|B3|Baseline|Total|Total of all reporting groups
7645|NCT02758171|O2|Outcome|Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets|The subjects were administered one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R).
7646|NCT02758171|O1|Outcome|FDC (10 mg Empagliflozin and 5 mg Linagliptin)|The subjects were administered one FDC film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin orally with 240 mL of water after an overnight fast of at least 10 hours (h), as a single dose in the fasted state on Day 1 of Test treatment (T).
7647|NCT02758171|E2|Reported Event|Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets|The subjects were administered one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R).
7648|NCT02758171|E1|Reported Event|FDC (10 mg Empagliflozin and 5 mg Linagliptin)|The subjects were administered one FDC film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin orally with 240 mL of water after an overnight fast of at least 10 hours (h), as a single dose in the fasted state on Day 1 of Test treatment (T).
7649|NCT02757053|B3|Baseline|Total|Total of all reporting groups
7650|NCT02757053|B2|Baseline|No Guardian Cap|The set of high school football players not wearing the Guardian Cap on their helmets
7651|NCT02757053|B1|Baseline|Guardian Cap|"The set of high school football players wearing the Guardian Cap on their helmets~Guardian Cap: The Guardian Cap is a third party add-on device attached to the facemask of a football helmet that covers the outside of the helmet with a soft material to reduce the initial impact severity, thus reducing the forces transmitted to the brain"
7652|NCT02757053|P2|Participant Flow|No Guardian Cap|The set of high school football players not wearing the Guardian Cap on their helmets
7653|NCT02757053|P1|Participant Flow|Guardian Cap|"The set of high school football players wearing the Guardian Cap on their helmets~Guardian Cap: The Guardian Cap is a third party add-on device attached to the facemask of a football helmet that covers the outside of the helmet with a soft material to reduce the initial impact severity, thus reducing the forces transmitted to the brain"
7654|NCT02757053|O2|Outcome|No Guardian Cap|The set of high school football players not wearing the Guardian Cap on their helmets
7655|NCT02757053|O1|Outcome|Guardian Cap|"The set of high school football players wearing the Guardian Cap on their helmets~Guardian Cap: The Guardian Cap is a third party add-on device attached to the facemask of a football helmet that covers the outside of the helmet with a soft material to reduce the initial impact severity, thus reducing the forces transmitted to the brain"
7656|NCT02757053|O2|Outcome|No Guardian Cap|The set of high school football players not wearing the Guardian Cap on their helmets
7657|NCT02757053|O1|Outcome|Guardian Cap|"The set of high school football players wearing the Guardian Cap on their helmets~Guardian Cap: The Guardian Cap is a third party add-on device attached to the facemask of a football helmet that covers the outside of the helmet with a soft material to reduce the initial impact severity, thus reducing the forces transmitted to the brain"
7658|NCT02757053|O2|Outcome|No Guardian Cap|The set of high school football players not wearing the Guardian Cap on their helmets
7659|NCT02757053|O1|Outcome|Guardian Cap|"The set of high school football players wearing the Guardian Cap on their helmets~Guardian Cap: The Guardian Cap is a third party add-on device attached to the facemask of a football helmet that covers the outside of the helmet with a soft material to reduce the initial impact severity, thus reducing the forces transmitted to the brain"
7660|NCT02757053|O2|Outcome|No Guardian Cap|The set of high school football players not wearing the Guardian Cap on their helmets
7661|NCT02757053|O1|Outcome|Guardian Cap|"The set of high school football players wearing the Guardian Cap on their helmets~Guardian Cap: The Guardian Cap is a third party add-on device attached to the facemask of a football helmet that covers the outside of the helmet with a soft material to reduce the initial impact severity, thus reducing the forces transmitted to the brain"
7662|NCT02757053|E2|Reported Event|No Guardian Cap|The set of high school football players not wearing the Guardian Cap on their helmets
7663|NCT02757053|E1|Reported Event|Guardian Cap|"The set of high school football players wearing the Guardian Cap on their helmets~Guardian Cap: The Guardian Cap is a third party add-on device attached to the facemask of a football helmet that covers the outside of the helmet with a soft material to reduce the initial impact severity, thus reducing the forces transmitted to the brain"
7664|NCT02756637|B3|Baseline|Total|Total of all reporting groups
7665|NCT02756637|B2|Baseline|Predictive Cohort|Patients with NLR who were assigned to a trial arm (chemo or no chemo)
7666|NCT02756637|B1|Baseline|Prognostic Cohort|Patients with NLR who completed curative therapy (surgery with or without chemo)
7667|NCT02756637|P2|Participant Flow|Predictive Cohort|Patients with NLR who were assigned to a trial arm (chemo or no chemo)
7668|NCT02756637|P1|Participant Flow|Prognostic Cohort|Patients with NLR who completed curative therapy (surgery with or without chemo)
7669|NCT02756637|O2|Outcome|Predictive Cohort|Patients with NLR who were assigned to a trial arm (chemo or no chemo)
7670|NCT02756637|O1|Outcome|Prognostic Cohort|Patients with NLR who completed curative therapy (surgery with or without chemo)
7671|NCT02756637|E2|Reported Event|Predictive Cohort|Patients with NLR who were assigned to a trial arm (chemo or no chemo)
7672|NCT02756637|E1|Reported Event|Prognostic Cohort|Patients with NLR who completed curative therapy (surgery with or without chemo)
7673|NCT02756624|B3|Baseline|Total|Total of all reporting groups
7674|NCT02756624|B2|Baseline|AC-170 Vehicle|"1 drop in each eye 3 times daily for up to 6 weeks~AC-170 Vehicle"
7675|NCT02756624|B1|Baseline|AC-170 0.24%|"1 drop in each eye 3 times daily for up to 6 weeks~AC-170 0.24%"
7676|NCT02756624|P2|Participant Flow|AC-170 Vehicle|"1 drop in each eye 3 times daily for up to 6 weeks~AC-170 Vehicle"
7677|NCT02756624|P1|Participant Flow|AC-170 0.24%|"1 drop in each eye 3 times daily for up to 6 weeks~AC-170 0.24%"
7678|NCT02756624|O2|Outcome|AC-170 Vehicle|"1 drop in each eye 3 times daily for up to 6 weeks~AC-170 Vehicle"
7679|NCT02756624|O1|Outcome|AC-170 0.24%|"1 drop in each eye 3 times daily for up to 6 weeks~AC-170 0.24%"
7689|NCT02756351|B2|Baseline|Reference Nasal Prong|"Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.~Inspiration Healthcare Inspire nCPAP Nasal Prong"
7690|NCT02756351|B1|Baseline|CytaCoat Nasal Prong|"The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.~CytaCoat Nasal Prong"
7691|NCT02756351|P2|Participant Flow|Reference Nasal Prong|"Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.~Inspiration Healthcare Inspire nCPAP Nasal Prong"
7692|NCT02756351|P1|Participant Flow|CytaCoat Nasal Prong|"The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.~CytaCoat Nasal Prong"
7693|NCT02756351|O2|Outcome|Reference Nasal Prong|"Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.~Inspiration Healthcare Inspire nCPAP Nasal Prong"
7694|NCT02756351|O1|Outcome|CytaCoat Nasal Prong|"The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.~CytaCoat Nasal Prong"
7695|NCT02756351|O2|Outcome|Reference Nasal Prong|"Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.~Inspiration Healthcare Inspire nCPAP Nasal Prong"
7696|NCT02756351|O1|Outcome|CytaCoat Nasal Prong|"The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.~CytaCoat Nasal Prong"
7697|NCT02756351|E2|Reported Event|Reference Nasal Prong|"Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.~Inspiration Healthcare Inspire nCPAP Nasal Prong"
7698|NCT02756351|E1|Reported Event|CytaCoat Nasal Prong|"The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.~CytaCoat Nasal Prong"
7699|NCT02755935|B1|Baseline|Implanted|"Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant~Cochlear Nucleus CI532: cochlear implantation"
7700|NCT02755935|P1|Participant Flow|Implanted|"Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant~Cochlear Nucleus CI532: cochlear implantation"
7701|NCT02755935|O1|Outcome|Implanted|"Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant~Cochlear Nucleus CI532: cochlear implantation"
7702|NCT02755935|O1|Outcome|Implanted|"Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant~Cochlear Nucleus CI532: cochlear implantation"
7703|NCT02755935|E1|Reported Event|Implanted|"Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant~Cochlear Nucleus CI532: cochlear implantation"
7704|NCT02755805|B3|Baseline|Total|Total of all reporting groups
7705|NCT02755805|B2|Baseline|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.~Attention Control"
7706|NCT02755805|B1|Baseline|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.~CO-OP"
7707|NCT02755805|P2|Participant Flow|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.~Attention Control"
7708|NCT02755805|P1|Participant Flow|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.~CO-OP"
7709|NCT02755805|O2|Outcome|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.~Attention Control"
7710|NCT02755805|O1|Outcome|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.~CO-OP"
7711|NCT02755805|O2|Outcome|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.~Attention Control"
7712|NCT02755805|O1|Outcome|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.~CO-OP"
7713|NCT02755805|O2|Outcome|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.~Attention Control"
9074|NCT02724644|O2|Outcome|Placebo|Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
7714|NCT02755805|O1|Outcome|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.~CO-OP"
7715|NCT02755805|O2|Outcome|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.~Attention Control"
7716|NCT02755805|O1|Outcome|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.~CO-OP"
7717|NCT02755805|E2|Reported Event|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.~Attention Control"
7718|NCT02755805|E1|Reported Event|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.~CO-OP"
7719|NCT02755090|B3|Baseline|Total|Total of all reporting groups
7720|NCT02755090|B2|Baseline|Standard Care Group (IV Sedation and Oxygen)|Within the IV sedation group, women will receive 100mcg fentanyl and 2mg midazolam at least two minutes prior to initiation of the procedure. This group will also receive 100% oxygen by a scented face mask. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.
7721|NCT02755090|B1|Baseline|Nitrous Oxide and IV Saline|"Participants in the nitrous oxide group will receive a scented face mask through which nitrous oxide will be administered. The nitrous content of the gas will be titrated up by 20% every 5 breaths with a goal of 70% N2O/ 30% O2 as tolerated by the participant. This group will also receive saline through an IV. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.~Nitrous Oxide: Participants in the nitrous oxide group will receive a scented face mask through which nitrous oxide will be administered. The nitrous content of the gas will be titrated up by 20% every 5 breaths with a goal of 70% N2O/ 30% O2 as tolerated by the participant. This group will also receive saline through an IV. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.~IV Saline"
7722|NCT02755090|P2|Participant Flow|Standard Care Group (IV Sedation and Oxygen)|Within the IV sedation group, women will receive 100mcg fentanyl and 2mg midazolam at least two minutes prior to initiation of the procedure. This group will also receive 100% oxygen by a scented face mask. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.
7723|NCT02755090|P1|Participant Flow|Nitrous Oxide and IV Saline|"Participants in the nitrous oxide group will receive a scented face mask through which nitrous oxide will be administered. The nitrous content of the gas will be titrated up by 20% every 5 breaths with a goal of 70% N2O/ 30% O2 as tolerated by the participant. This group will also receive saline through an IV. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.~Nitrous Oxide: Participants in the nitrous oxide group will receive a scented face mask through which nitrous oxide will be administered. The nitrous content of the gas will be titrated up by 20% every 5 breaths with a goal of 70% N2O/ 30% O2 as tolerated by the participant. This group will also receive saline through an IV. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.~IV Saline"
7724|NCT02755090|O2|Outcome|Standard Care Group (IV Sedation and Oxygen)|Within the IV sedation group, women will receive 100mcg fentanyl and 2mg midazolam at least two minutes prior to initiation of the procedure. This group will also receive 100% oxygen by a scented face mask. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.
7725|NCT02755090|O1|Outcome|Nitrous Oxide and IV Saline|"Participants in the nitrous oxide group will receive a scented face mask through which nitrous oxide will be administered. The nitrous content of the gas will be titrated up by 20% every 5 breaths with a goal of 70% N2O/ 30% O2 as tolerated by the participant. This group will also receive saline through an IV. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.~Nitrous Oxide: Participants in the nitrous oxide group will receive a scented face mask through which nitrous oxide will be administered. The nitrous content of the gas will be titrated up by 20% every 5 breaths with a goal of 70% N2O/ 30% O2 as tolerated by the participant. This group will also receive saline through an IV. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.~IV Saline"
7726|NCT02755090|O2|Outcome|Standard Care Group (IV Sedation and Oxygen)|Within the IV sedation group, women will receive 100mcg fentanyl and 2mg midazolam at least two minutes prior to initiation of the procedure. This group will also receive 100% oxygen by a scented face mask. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.
7727|NCT02755090|O1|Outcome|Nitrous Oxide and IV Saline|"Participants in the nitrous oxide group will receive a scented face mask through which nitrous oxide will be administered. The nitrous content of the gas will be titrated up by 20% every 5 breaths with a goal of 70% N2O/ 30% O2 as tolerated by the participant. This group will also receive saline through an IV. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.~Nitrous Oxide: Participants in the nitrous oxide group will receive a scented face mask through which nitrous oxide will be administered. The nitrous content of the gas will be titrated up by 20% every 5 breaths with a goal of 70% N2O/ 30% O2 as tolerated by the participant. This group will also receive saline through an IV. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.~IV Saline"
11519|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
7728|NCT02755090|E2|Reported Event|Standard Care Group (IV Sedation and Oxygen)|Within the IV sedation group, women will receive 100mcg fentanyl and 2mg midazolam at least two minutes prior to initiation of the procedure. This group will also receive 100% oxygen by a scented face mask. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.
7729|NCT02755090|E1|Reported Event|Nitrous Oxide and IV Saline|"Participants in the nitrous oxide group will receive a scented face mask through which nitrous oxide will be administered. The nitrous content of the gas will be titrated up by 20% every 5 breaths with a goal of 70% N2O/ 30% O2 as tolerated by the participant. This group will also receive saline through an IV. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.~Nitrous Oxide: Participants in the nitrous oxide group will receive a scented face mask through which nitrous oxide will be administered. The nitrous content of the gas will be titrated up by 20% every 5 breaths with a goal of 70% N2O/ 30% O2 as tolerated by the participant. This group will also receive saline through an IV. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.~IV Saline"
7730|NCT02754492|B5|Baseline|Total|Total of all reporting groups
7731|NCT02754492|B4|Baseline|Unassigned|Subject and subsequent platelet product not assignable as single, double, triple (product not tested and/or was excluded from analysis).
7732|NCT02754492|B3|Baseline|Triple Platelet Product|"Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7733|NCT02754492|B2|Baseline|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7734|NCT02754492|B1|Baseline|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7735|NCT02754492|P4|Participant Flow|Unassigned|Participant and subsequent platelet product not assignable as single, double, triple (product not tested and/or was excluded from analysis).
7736|NCT02754492|P3|Participant Flow|Triple Platelet Product|"Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7737|NCT02754492|P2|Participant Flow|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7738|NCT02754492|P1|Participant Flow|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7739|NCT02754492|O3|Outcome|Triple Platelet Product|"Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7740|NCT02754492|O2|Outcome|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7741|NCT02754492|O1|Outcome|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7742|NCT02754492|O3|Outcome|Triple Platelet Product|"Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7743|NCT02754492|O2|Outcome|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7744|NCT02754492|O1|Outcome|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7745|NCT02754492|E4|Reported Event|Unassigned|Subject and subsequent platelet product not assignable as single, double, triple (product not tested and/or was excluded from analysis).
7746|NCT02754492|E3|Reported Event|Triple Platelet Product|"Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
8387|NCT02741245|B2|Baseline|Rosuvastatin 2.5 mg|1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
7747|NCT02754492|E2|Reported Event|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7748|NCT02754492|E1|Reported Event|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7749|NCT02754440|B5|Baseline|Total|Total of all reporting groups
7750|NCT02754440|B4|Baseline|Unassigned|Participant and subsequent platelet product not assignable as single, double, triple (product not tested and/or was excluded from analysis).
7751|NCT02754440|B3|Baseline|Triple Platelet Product|"Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7752|NCT02754440|B2|Baseline|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7753|NCT02754440|B1|Baseline|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7754|NCT02754440|P4|Participant Flow|Unassigned|Participant and subsequent platelet product not assignable as single, double, triple (product not tested and/or was excluded from analysis).
7755|NCT02754440|P3|Participant Flow|Triple Platelet Product|"Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7756|NCT02754440|P2|Participant Flow|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7757|NCT02754440|P1|Participant Flow|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7758|NCT02754440|O3|Outcome|Triple Platelet Product|"Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7759|NCT02754440|O2|Outcome|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7760|NCT02754440|O1|Outcome|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7761|NCT02754440|O3|Outcome|Triple Platelet Product|"Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7762|NCT02754440|O2|Outcome|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7763|NCT02754440|O1|Outcome|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7764|NCT02754440|E4|Reported Event|Unassigned|Participant and subsequent platelet product not assignable as single, double, triple (product not tested and/or was excluded from analysis).
7765|NCT02754440|E3|Reported Event|Triple Platelet Product|"Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7766|NCT02754440|E2|Reported Event|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
8216|NCT02745626|O1|Outcome|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
7767|NCT02754440|E1|Reported Event|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
7768|NCT02753699|B4|Baseline|Total|Total of all reporting groups
7769|NCT02753699|B3|Baseline|From Study 2211|All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
7770|NCT02753699|B2|Baseline|From Study 2301|All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.
7771|NCT02753699|B1|Baseline|From Study 2210|All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.
7772|NCT02753699|P3|Participant Flow|From Study 2211|All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
7773|NCT02753699|P2|Participant Flow|From Study 2301|All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.
7774|NCT02753699|P1|Participant Flow|From Study 2210|All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.
7775|NCT02753699|O4|Outcome|From Study 2211 Overall|All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
7776|NCT02753699|O3|Outcome|From Study 2211 IFN-free|Participants enrolled from CDEB025A2211 (n=54) who had been treated with alisporivir in interferon-free (INF-free) regimens during the feeder study.
7777|NCT02753699|O2|Outcome|From Study 2301|All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.
7778|NCT02753699|O1|Outcome|From Study 2210|All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.
7779|NCT02753699|O4|Outcome|From Study 2211 Overall|All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
7780|NCT02753699|O3|Outcome|From Study 2211 IFN-free|Participants enrolled from CDEB025A2211 (n=54) who had been treated with alisporivir in interferon-free (INF-free) regimens during the feeder study.
7781|NCT02753699|O2|Outcome|From Study 2301|All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.
7782|NCT02753699|O1|Outcome|From Study 2210|All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.
7783|NCT02753699|E4|Reported Event|From Study 2211 Overall|All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
7784|NCT02753699|E3|Reported Event|From Study 2211 IFN-free|Participants enrolled from CDEB025A2211 (n=54) who had been treated with alisporivir in interferon-free (INF-free) regimens during the feeder study.
7785|NCT02753699|E2|Reported Event|From Study 2301|All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.
7786|NCT02753699|E1|Reported Event|From Study 2210|All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.
7787|NCT02753413|B3|Baseline|Total|Total of all reporting groups
7788|NCT02753413|B2|Baseline|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7789|NCT02753413|B1|Baseline|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7790|NCT02753413|P2|Participant Flow|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7791|NCT02753413|P1|Participant Flow|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7792|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7793|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7794|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7795|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7796|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7797|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7798|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7799|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7800|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7801|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7802|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7803|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7804|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7805|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7806|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7807|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7808|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7809|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7810|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7811|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7812|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7813|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7814|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7815|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7816|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7817|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7818|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7819|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7820|NCT02753413|E2|Reported Event|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7821|NCT02753413|E1|Reported Event|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
7822|NCT02753075|B4|Baseline|Total|Total of all reporting groups
7823|NCT02753075|B3|Baseline|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7824|NCT02753075|B2|Baseline|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7825|NCT02753075|B1|Baseline|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7826|NCT02753075|P3|Participant Flow|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7827|NCT02753075|P2|Participant Flow|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
8217|NCT02745626|O3|Outcome|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
7828|NCT02753075|P1|Participant Flow|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 minute (min) and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 milliliter (mL) of Experimental Oral Rinse 1 (1.5% weight by weight [w/w] dipotassium oxalate monohydrate [KOX], 0 parts per million [ppm] fluoride [F]) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7829|NCT02753075|O3|Outcome|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7830|NCT02753075|O2|Outcome|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7831|NCT02753075|O1|Outcome|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7832|NCT02753075|O3|Outcome|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7833|NCT02753075|O2|Outcome|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7834|NCT02753075|O1|Outcome|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7835|NCT02753075|O3|Outcome|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7836|NCT02753075|O2|Outcome|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7837|NCT02753075|O1|Outcome|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7838|NCT02753075|O3|Outcome|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7839|NCT02753075|O2|Outcome|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7840|NCT02753075|O1|Outcome|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm fluoride F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7841|NCT02753075|O3|Outcome|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7842|NCT02753075|O2|Outcome|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7843|NCT02753075|O1|Outcome|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm fluoride F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7844|NCT02753075|O2|Outcome|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
8218|NCT02745626|O2|Outcome|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
11520|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
7845|NCT02753075|O1|Outcome|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7846|NCT02753075|O3|Outcome|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7847|NCT02753075|O2|Outcome|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7848|NCT02753075|O1|Outcome|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7849|NCT02753075|E3|Reported Event|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7850|NCT02753075|E2|Reported Event|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F, pH 4.5) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7851|NCT02753075|E1|Reported Event|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 minute (min) and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 milliliter (mL) of Experimental Oral Rinse 1 (1.5% weight by weight [w/w] dipotassium oxalate monohydrate [KOX], 0 parts per million [ppm] fluoride [F], pH 4.5) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
7852|NCT02752802|B3|Baseline|Total|Total of all reporting groups
7853|NCT02752802|B2|Baseline|Control|"The control group will include standard of care for diagnostic coronary angiograms.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
7854|NCT02752802|B1|Baseline|Treatment|"The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
7855|NCT02752802|P2|Participant Flow|Control|"The control group will include standard of care for diagnostic coronary angiograms.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
7856|NCT02752802|P1|Participant Flow|Treatment|"The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
7857|NCT02752802|O1|Outcome|Treatment|"The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
7858|NCT02752802|O2|Outcome|Treatment|"The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
7859|NCT02752802|O1|Outcome|Control|"The control group will include standard of care for diagnostic coronary angiograms.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
7860|NCT02752802|O2|Outcome|Control|"The control group will include standard of care for diagnostic coronary angiograms.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
7861|NCT02752802|O1|Outcome|Treatment|"The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
7862|NCT02752802|E2|Reported Event|Control|"The control group will include standard of care for diagnostic coronary angiograms.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
7863|NCT02752802|E1|Reported Event|Treatment|"The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
7864|NCT02752633|B1|Baseline|Allopurinol/Febuxostat Treatment|This is a clinical trial comparing the effect of 80 mg/day of febuxostat to 400 mg/day of allopurinol on the urinary excretion of 2,8-dihydroxyadenine in patients with APRT deficiency.
7865|NCT02752633|P1|Participant Flow|Allopurinol/Febuxostat Treatment|This is a clinical trial comparing the effect of 80 mg/day of febuxostat to 400 mg/day of allopurinol on the urinary excretion of 2,8-dihydroxyadenine in patients with APRT deficiency.
7866|NCT02752633|O1|Outcome|Allopurinol/Febuxostat Treatment|"Following a 7 day washout period all patients receive allopurinol (400 mg/day) as a single daily dose for 2 weeks. Following another 7 day washout period all participants receive febuxostat, 80 mg/day as a single daily dose, for 2 weeks.~Allopurinol: This is a clinical trial comparing the effect of 80 mg/day of febuxostat to 400 mg/day of allopurinol on the urinary excretion of 2,8-dihydroxyadenine in patients with APRT deficiency.~Febuxostat: This is a clinical trial comparing the effect of 80 mg/day of febuxostat to 400 mg/day of allopurinol on the urinary excretion of 2,8-dihydroxyadenine in patients with APRT deficiency."
7867|NCT02752633|E1|Reported Event|Allopurinol/Febuxostat Treatment|This is a clinical trial comparing the effect of 80 mg/day of febuxostat to 400 mg/day of allopurinol on the urinary excretion of 2,8-dihydroxyadenine in patients with APRT deficiency.
7868|NCT02752490|B3|Baseline|Total|Total of all reporting groups
7869|NCT02752490|B2|Baseline|Indicated Use of Maternal Oxygen|Administration of maternal oxygen, 100% fraction of inspired oxygen (FiO2) at 10 liters/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur.
7870|NCT02752490|B1|Baseline|Liberal Use of Maternal Oxygen|Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by the American Congress of Obstetrics and Gynecology (ACOG) at the discretion of the primary nurse or physician
7871|NCT02752490|P2|Participant Flow|Indicated Use of Maternal Oxygen|Administration of maternal oxygen, 100% fraction of inspired oxygen (FiO2) at 10 liters/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur.
7872|NCT02752490|P1|Participant Flow|Liberal Use of Maternal Oxygen|Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by the American Congress of Obstetrics and Gynecology (ACOG) at the discretion of the primary nurse or physician
7873|NCT02752490|O2|Outcome|Indicated Use of Maternal Oxygen|Administration of maternal oxygen, 100% fraction of inspired oxygen (FiO2) at 10 liters/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur.
7874|NCT02752490|O1|Outcome|Liberal Use of Maternal Oxygen|Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by the American Congress of Obstetrics and Gynecology (ACOG) at the discretion of the primary nurse or physician
7875|NCT02752490|O2|Outcome|Indicated Use of Maternal Oxygen|Administration of maternal oxygen, 100% fraction of inspired oxygen (FiO2) at 10 liters/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur.
7876|NCT02752490|O1|Outcome|Liberal Use of Maternal Oxygen|Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by the American Congress of Obstetrics and Gynecology (ACOG) at the discretion of the primary nurse or physician
7877|NCT02752490|O2|Outcome|Indicated Use of Maternal Oxygen|Administration of maternal oxygen, 100% fraction of inspired oxygen (FiO2) at 10 liters/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur.
7878|NCT02752490|O1|Outcome|Liberal Use of Maternal Oxygen|Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by the American Congress of Obstetrics and Gynecology (ACOG) at the discretion of the primary nurse or physician
7879|NCT02752490|O2|Outcome|Indicated Use of Maternal Oxygen|Administration of maternal oxygen, 100% fraction of inspired oxygen (FiO2) at 10 liters/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur.
7880|NCT02752490|O1|Outcome|Liberal Use of Maternal Oxygen|Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by the American Congress of Obstetrics and Gynecology (ACOG) at the discretion of the primary nurse or physician
7881|NCT02752490|O2|Outcome|Indicated Use of Maternal Oxygen|Administration of maternal oxygen, 100% fraction of inspired oxygen (FiO2) at 10 liters/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur.
7882|NCT02752490|O1|Outcome|Liberal Use of Maternal Oxygen|Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by the American Congress of Obstetrics and Gynecology (ACOG) at the discretion of the primary nurse or physician
7883|NCT02752490|O2|Outcome|Indicated Use of Maternal Oxygen|Administration of maternal oxygen, 100% fraction of inspired oxygen (FiO2) at 10 liters/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur.
7884|NCT02752490|O1|Outcome|Liberal Use of Maternal Oxygen|Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by the American Congress of Obstetrics and Gynecology (ACOG) at the discretion of the primary nurse or physician
7885|NCT02752490|O2|Outcome|Indicated Use of Maternal Oxygen|Administration of maternal oxygen, 100% fraction of inspired oxygen (FiO2) at 10 liters/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur.
7886|NCT02752490|O1|Outcome|Liberal Use of Maternal Oxygen|Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by the American Congress of Obstetrics and Gynecology (ACOG) at the discretion of the primary nurse or physician
8388|NCT02741245|B1|Baseline|Ezetimibe 10 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
7887|NCT02752490|O2|Outcome|Indicated Use of Maternal Oxygen|Administration of maternal oxygen, 100% fraction of inspired oxygen (FiO2) at 10 liters/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur.
7888|NCT02752490|O1|Outcome|Liberal Use of Maternal Oxygen|Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by the American Congress of Obstetrics and Gynecology (ACOG) at the discretion of the primary nurse or physician
7889|NCT02752490|E2|Reported Event|Indicated Use of Maternal Oxygen|Administration of maternal oxygen, 100% fraction of inspired oxygen (FiO2) at 10 liters/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur.
7890|NCT02752490|E1|Reported Event|Liberal Use of Maternal Oxygen|Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by the American Congress of Obstetrics and Gynecology (ACOG) at the discretion of the primary nurse or physician
7891|NCT02751450|B3|Baseline|Total|Total of all reporting groups
7892|NCT02751450|B2|Baseline|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
7893|NCT02751450|B1|Baseline|Stannous Fluoride|Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
7894|NCT02751450|P2|Participant Flow|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
7895|NCT02751450|P1|Participant Flow|Stannous Fluoride|Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million, ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
7896|NCT02751450|O2|Outcome|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
7897|NCT02751450|O1|Outcome|Stannous Fluoride|Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
7898|NCT02751450|O2|Outcome|Sodium Monofluorophosphate Dentifrice|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
7899|NCT02751450|O1|Outcome|Stannous Fluoride Dentifice|Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
7900|NCT02751450|O2|Outcome|Sodium Monofluorophosphate Dentifrice|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
7917|NCT02751320|O3|Outcome|Test Product 3|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.85 % phytate, 1150 ppm F, 0.3% ZnCl2) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
12494|NCT02647320|O4|Outcome|Sitagliptin 100 mg|One sitagliptin 100 mg over-capsule and placebo
7901|NCT02751450|O1|Outcome|Stannous Fluoride Dentifice|Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
7902|NCT02751450|O2|Outcome|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
7903|NCT02751450|O1|Outcome|Stannous Fluoride|Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
7904|NCT02751450|E2|Reported Event|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
7905|NCT02751450|E1|Reported Event|Stannous Fluoride|Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
7906|NCT02751320|B1|Baseline|All Randomized Participants|All randomized participants were included for baseline evaluation.
7907|NCT02751320|P1|Participant Flow|Overall Study|This was a single-centre, randomized, blinded (examiner and laboratory analyst), placebo-controlled, 6-treatment, 4-period cross-over, incomplete block design, in situ caries study in healthy adults who wore a removable bilateral mandibular partial denture. Each participant received Test Product 1 (Dentifrice containing 0.425 % weight by weight (w/w) phytate, and 1150 parts per million [ppm] fluoride [F]), Test Product 2 (Dentifrice containing 0.85 % w/w phytate, and 1150 ppm fluoride), Test Product 3 (Dentifrice containing 0.85 % w/w phytate, 0.3% zinc chloride, 0.5% sodium citrate, and 1150 ppm fluoride), Reference Product 1 (0 ppm fluoride), Reference Product 2 (Dentrifrice containing 1150 ppm fluoride toothpaste and Reference Product 3 (Dentrifrice containing 0.3% zinc chloride , 0.5% sodium citrate, and 1150 ppm fluoride).
7908|NCT02751320|O6|Outcome|Reference Product 3|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 1150ppm F, 0.3% ZnCl2) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7909|NCT02751320|O5|Outcome|Reference Product 2|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 1150ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7910|NCT02751320|O4|Outcome|Reference Product 1|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0 ppm fluoride) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7911|NCT02751320|O3|Outcome|Test Product 3|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.85 % phytate, 1150 ppm F, 0.3% ZnCl2) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7912|NCT02751320|O2|Outcome|Test Product 2|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.85 % phytate, 1150 ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7913|NCT02751320|O1|Outcome|Test Product 1|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.425 % phytate, 1150 ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7914|NCT02751320|O6|Outcome|Reference Product 3|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 1150ppm F, 0.3% ZnCl2) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7915|NCT02751320|O5|Outcome|Reference Product 2|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 1150ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7916|NCT02751320|O4|Outcome|Reference Product 1|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0 ppm fluoride) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7977|NCT02750813|O1|Outcome|DAILIES TOTAL1|Delefilcon A contact lenses worn bilaterally for 14 days in a daily wear, daily disposable modality
7918|NCT02751320|O2|Outcome|Test Product 2|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.85 % phytate, 1150 ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7919|NCT02751320|O1|Outcome|Test Product 1|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.425 % phytate, 1150 ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7920|NCT02751320|O4|Outcome|Reference Product 3|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 1150ppm F, 0.3% ZnCl2) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7921|NCT02751320|O3|Outcome|Reference Product 2|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 1150ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7922|NCT02751320|O2|Outcome|Test Product 3|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.85 % phytate, 1150 ppm F, 0.3% ZnCl2) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7923|NCT02751320|O1|Outcome|Test Product 2|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.85 % phytate, 1150 ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7924|NCT02751320|O4|Outcome|Reference Product 2|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 1150ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7925|NCT02751320|O3|Outcome|Reference Product 1|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned reference dentifrice (containing 0 ppm fluoride) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7926|NCT02751320|O2|Outcome|Test Product 2|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.85 % phytate, 1150 ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7927|NCT02751320|O1|Outcome|Test Product 1|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.425 % phytate, 1150 ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7928|NCT02751320|O4|Outcome|Reference Product 3|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 1150ppm F, 0.3% ZnCl2) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7929|NCT02751320|O3|Outcome|Reference Product 2|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 1150ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7930|NCT02751320|O2|Outcome|Test Product 3|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.85 % phytate, 1150 ppm F, 0.3% ZnCl2) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s
7931|NCT02751320|O1|Outcome|Test Product 2|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.85 % phytate, 1150 ppm F) for one timed minute twice daily, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7932|NCT02751320|O4|Outcome|Reference Product 2|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned reference dentifrice (containing 1150ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7933|NCT02751320|O3|Outcome|Reference Product 1|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned reference dentifrice (containing 0 ppm fluoride) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7934|NCT02751320|O2|Outcome|Test Product 2|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned experimental dentifrice (containing 0.85 % phytate, 1150 ppm F) for one timed minute twice daily, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7935|NCT02751320|O1|Outcome|Test Product 1|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned experimental dentifrice (containing 0.425 % phytate, 1150 ppm F) for one timed minute twice daily, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15 milliliters (ml) of tap water for approximately 10 seconds (s).
7936|NCT02751320|E6|Reported Event|Reference Product 3|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 1150ppm F, 0.3% ZnCl2) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7978|NCT02750813|E3|Reported Event|ACUVUE OASYS 1-DAY (AO1D)|All subjects exposed to AO1D contact lenses, except for lenses used for parameter optimization and fitting
7937|NCT02751320|E5|Reported Event|Reference Product 2|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 1150ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7938|NCT02751320|E4|Reported Event|Reference Product 1|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0 ppm fluoride) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7939|NCT02751320|E3|Reported Event|Test Product 3|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.85 % phytate, 1150 ppm F, 0.3% ZnCl2) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s
7940|NCT02751320|E2|Reported Event|Test Product 2|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.85 % phytate, 1150 ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7941|NCT02751320|E1|Reported Event|Test Product 1|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.425 % phytate, 1150 ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
7942|NCT02750943|B3|Baseline|Total|Total of all reporting groups
7943|NCT02750943|B2|Baseline|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
7944|NCT02750943|B1|Baseline|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
7945|NCT02750943|P2|Participant Flow|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
7946|NCT02750943|P1|Participant Flow|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% weight by weight (w/w) stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
7947|NCT02750943|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
7948|NCT02750943|O1|Outcome|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
7949|NCT02750943|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
7950|NCT02750943|O1|Outcome|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
7951|NCT02750943|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
7952|NCT02750943|O1|Outcome|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
7953|NCT02750943|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
7954|NCT02750943|O1|Outcome|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
7955|NCT02750943|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
7956|NCT02750943|O1|Outcome|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
7957|NCT02750943|E2|Reported Event|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
7958|NCT02750943|E1|Reported Event|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
7979|NCT02750813|E2|Reported Event|DAILIES TOTAL1 (DT1)|All subjects exposed to DT1 contact lenses, except for lenses used for parameter optimization and fitting
7980|NCT02750813|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to initiation of study treatment
7981|NCT02750709|B1|Baseline|All Study Participants|
7959|NCT02750930|B1|Baseline|Albiglutide Liquid|The participants in this arm, self-administered, albiglutide liquid drug product 50 mg at a volume of 1 mL as a single dose subcutaneous injection in the abdomen, thigh or upper arm region, once weekly, for 26-weeks. It was administered on the same day each week, anytime during the day without regards to meals. The first dose was self-administered by the participant in the supervision from clinic staff. All further doses of study treatment were self-administered by the participant.
7960|NCT02750930|P1|Participant Flow|Albiglutide Liquid|The participants in this arm, self-administered, albiglutide liquid drug product 50 milligram (mg) at a volume of 1 millilitre (mL) as a single dose subcutaneous injection in the abdomen, thigh or upper arm region, once weekly, for 26-weeks. It was administered on the same day each week, anytime during the day without regards to meals. The first dose was self-administered by the participant in the supervision from clinic staff. All further doses of study treatment were self-administered by the participant.
7961|NCT02750930|O1|Outcome|Albiglutide Liquid|The participants in this arm, self-administered, albiglutide liquid drug product 50 mg at a volume of 1 mL, as a single dose subcutaneous injection in the abdomen, thigh or upper arm region, once weekly, for 26-weeks. It was administered on the same day each week, anytime during the day without regards to meals. The first dose was self-administered by the participant in the supervision from clinic staff. All further doses of study treatment were self-administered by the participant.
7962|NCT02750930|O1|Outcome|Albiglutide Liquid|The participants in this arm, self-administered, albiglutide liquid drug product 50 mg at a volume of 1 mL, as a single dose subcutaneous injection in the abdomen, thigh or upper arm region, once weekly, for 26-weeks. It was administered on the same day each week, anytime during the day without regards to meals. The first dose was self-administered by the participant in the supervision from clinic staff. All further doses of study treatment were self-administered by the participant.
7963|NCT02750930|O1|Outcome|Albiglutide Liquid|The participants in this arm, self-administered, albiglutide liquid drug product 50 mg at a volume of 1 mL, as a single dose subcutaneous injection in the abdomen, thigh or upper arm region, once weekly, for 26-weeks. It was administered on the same day each week, anytime during the day without regards to meals. The first dose was self-administered by the participant in the supervision from clinic staff. All further doses of study treatment were self-administered by the participant.
7964|NCT02750930|O1|Outcome|Albiglutide Liquid|The participants in this arm, self-administered, albiglutide liquid drug product 50 mg at a volume of 1 mL, as a single dose subcutaneous injection in the abdomen, thigh or upper arm region, once weekly, for 26-weeks. It was administered on the same day each week, anytime during the day without regards to meals. The first dose was self-administered by the participant in the supervision from clinic staff. All further doses of study treatment were self-administered by the participant.
7965|NCT02750930|O1|Outcome|Albiglutide Liquid|The participants in this arm, self-administered, albiglutide liquid drug product 50 mg at a volume of 1 mL, as a single dose subcutaneous injection in the abdomen, thigh or upper arm region, once weekly, for 26-weeks. It was administered on the same day each week, anytime during the day without regards to meals. The first dose was self-administered by the participant in the supervision from clinic staff. All further doses of study treatment were self-administered by the participant.
7966|NCT02750930|O1|Outcome|Albiglutide Liquid|The participants in this arm, self-administered, albiglutide liquid drug product 50 mg at a volume of 1 mL, as a single dose subcutaneous injection in the abdomen, thigh or upper arm region, once weekly, for 26-weeks. It was administered on the same day each week, anytime during the day without regards to meals. The first dose was self-administered by the participant in the supervision from clinic staff. All further doses of study treatment were self-administered by the participant.
7967|NCT02750930|O1|Outcome|Albiglutide Liquid|The participants in this arm, self-administered, albiglutide liquid drug product 50 mg at a volume of 1 mL, as a single dose subcutaneous injection in the abdomen, thigh or upper arm region, once weekly, for 26-weeks. It was administered on the same day each week, anytime during the day without regards to meals. The first dose was self-administered by the participant in the supervision from clinic staff. All further doses of study treatment were self-administered by the participant.
7968|NCT02750930|O1|Outcome|Albiglutide Liquid|The participants in this arm, self-administered, albiglutide liquid drug product 50 mg at a volume of 1 mL, as a single dose subcutaneous injection in the abdomen, thigh or upper arm region, once weekly, for 26-weeks. It was administered on the same day each week, anytime during the day without regards to meals. The first dose was self-administered by the participant in the supervision from clinic staff. All further doses of study treatment were self-administered by the participant.
7969|NCT02750930|O1|Outcome|Albiglutide Liquid|The participants in this arm, self-administered, albiglutide liquid drug product 50 mg at a volume of 1 mL, as a single dose subcutaneous injection in the abdomen, thigh or upper arm region, once weekly, for 26-weeks. It was administered on the same day each week, anytime during the day without regards to meals. The first dose was self-administered by the participant in the supervision from clinic staff. All further doses of study treatment were self-administered by the participant.
7970|NCT02750930|E1|Reported Event|Albiglutide Liquid|The participants in this arm, self-administered, albiglutide liquid drug product 50 mg at a volume of 1 mL, as a single dose subcutaneous injection in the abdomen, thigh or upper arm region, once weekly, for 26-weeks. It was administered on the same day each week, anytime during the day without regards to meals. The first dose was self-administered by the participant in the supervision from clinic staff. All further doses of study treatment were self-administered by the participant.
7971|NCT02750813|B1|Baseline|Overall|Delefilcon A and senofilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment.
7972|NCT02750813|P2|Participant Flow|AO1D, Then DT1|Senofilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 14 days in a daily wear, daily disposable modality.
7973|NCT02750813|P1|Participant Flow|DT1, Then AO1D|Delefilcon A contact lenses worn first, followed by senofilcon A contact lenses. Each product worn bilaterally (in both eyes) for 14 days in a daily wear, daily disposable modality.
7974|NCT02750813|O2|Outcome|AO1D|Senofilcon A contact lenses worn bilaterally for 14 days in a daily wear, daily disposable modality
7975|NCT02750813|O1|Outcome|DAILIES TOTAL1|Delefilcon A contact lenses worn bilaterally for 14 days in a daily wear, daily disposable modality
7976|NCT02750813|O2|Outcome|AO1D|Senofilcon A contact lenses worn bilaterally for 14 days in a daily wear, daily disposable modality
7982|NCT02750709|P6|Participant Flow|Treatment Sequence C (Reference) - B (TP 2) - A (TP 1)|"Subjects will receive a single 10 mg hard capsule of Orfadin (Reference) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 2, 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.~Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
7983|NCT02750709|P5|Participant Flow|Treatment Sequence C (Reference) - A (TP 1) - B (TP 2)|"Subjects will receive a single 10 mg hard capsule of Orfadin (Reference) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 2, and 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.~Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
7984|NCT02750709|P4|Participant Flow|Treatment Sequence B (TP 2) - C (Reference) - A (TP 1)|"Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 1, 10 mg hard capsule of Orfadin (Reference) in treatment period 2, and 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 3, and under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.~Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
7985|NCT02750709|P3|Participant Flow|Treatment Sequence B (TP 2) - A (TP 1) - C (Reference)|"Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 2, and 10 mg hard capsule of Orfadin (Reference) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.~Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
7986|NCT02750709|P2|Participant Flow|Treatment Sequence A (TP 1) - C (Reference) - B (TP 2)|"Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 2) in treatment period 1, 10 mg hard capsule of Orfadin (Reference) in treatment period 2, and 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.~Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
7987|NCT02750709|P1|Participant Flow|Treatment Sequence A (TP 1) - B (TP 2) - C (Reference)|"Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 2, and 10 mg hard capsule of Orfadin (Reference) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.~Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
7988|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
7989|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
7990|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
7991|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
7992|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
7993|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
7994|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
7995|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
7996|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
7997|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
7998|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
7999|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
8000|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
8001|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
8002|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
8003|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
8004|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
8005|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
8006|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
8007|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
8008|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
8009|NCT02750709|E3|Reported Event|Reference Product|ORFADIN® hard capsule, 10 mg
8010|NCT02750709|E2|Reported Event|Test Product 2|Nitisinone Tablet (High Compritol), 10 mg
8011|NCT02750709|E1|Reported Event|Test Product 1|Nitisinone Tablet, 10 mg
8012|NCT02750345|B1|Baseline|All Study Participants|Grouped by all participants as this is how overall data has been collected.
8219|NCT02745626|O1|Outcome|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
20036|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
8013|NCT02750345|P6|Participant Flow|Sequence Reference - TP 2 - TP 1|"Subjects will receive a single 10 mg hard capsule of Orfadin (Reference) in treatment period 1, 10 mg tablet of Nitisinone Baked Tablet (Test Product 2) in treatment period 2, and 10 mg tablet of Nitisinone (Test Product 1) in treatment period 3, and under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.~Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
8014|NCT02750345|P5|Participant Flow|Sequence Reference - TP 1 - TP 2|"Subjects will receive a single 10 mg hard capsule of Orfadin (Reference) in treatment period 1, 10 mg tablet of Nitisinone (Test Product 1) in treatment period 2, and 10 mg tablet of Nitisinone Baked Tablet (Test Product 2) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.~Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
8015|NCT02750345|P4|Participant Flow|Sequence TP 2 - Reference - TP 1|"Subjects will receive a single 10 mg tablet of Nitisinone Baked Tablet (Test Product 2) in treatment period 1, 10 mg hard capsule of Orfadin (Reference) in treatment period 2, and 10 mg tablet of Nitisinone (Test Product 1) in treatment period 3, and under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.~Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
8016|NCT02750345|P3|Participant Flow|Sequence TP 2 - TP 1 - Reference|"Subjects will receive a single 10 mg tablet of Nitisinone Baked Tablet (Test Product 2) in treatment period 1, 10 mg tablet of Nitisinone (Test Product 1) in treatment period 2, and 10 mg hard capsule of Orfadin (Reference) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.~Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
8017|NCT02750345|P2|Participant Flow|Sequence TP 1 - Reference - TP 2|"Subjects will receive a single 10 mg tablet of Nitisinone (Test Product 1) in treatment period 1, 10 mg hard capsule of Orfadin (Reference) in treatment period 2, and 10 mg tablet of Nitisinone Baked Tablet (Test Product 2) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.~Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
8018|NCT02750345|P1|Participant Flow|Sequence TP 1 - TP 2 - Reference|"Subjects will receive a single 10 mg tablet of Nitisinone (Test Product 1 (TP 1)) in treatment period 1, 10 mg tablet of Nitisinone Baked Tablet (Test Product 2 (TP 2)) in treatment period 2, and 10 mg hard capsule of Orfadin (Reference) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.~Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
8019|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
8020|NCT02750345|O2|Outcome|Treatment Period 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
8021|NCT02750345|O1|Outcome|Treatment Period 1|10 mg Nitisinone Tablet
8022|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
8023|NCT02750345|O2|Outcome|Treatment Period 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
8024|NCT02750345|O1|Outcome|Treatment Period 1|10 mg Nitisinone Tablet
8025|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
8026|NCT02750345|O2|Outcome|Treatment Period 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
8027|NCT02750345|O1|Outcome|Treatment Period 1|10 mg Nitisinone Tablet
8028|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
8029|NCT02750345|O2|Outcome|Treatment Period 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
8030|NCT02750345|O1|Outcome|Treatment Period 1|10 mg Nitisinone Tablet
8031|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
8032|NCT02750345|O2|Outcome|Treatment Period 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
8033|NCT02750345|O1|Outcome|Treatment Period 1|10 mg Nitisinone Tablet
8034|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
8035|NCT02750345|O2|Outcome|Treatment Period 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
8036|NCT02750345|O1|Outcome|Treatment Period 1|10 mg Nitisinone Tablet
8037|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
8038|NCT02750345|O2|Outcome|Test Product 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
8039|NCT02750345|O1|Outcome|Test Product 1|10 mg Nitisinone Tablet
8040|NCT02750345|E3|Reported Event|Reference Product|ORFADIN®, 10 mg hard capsule
8041|NCT02750345|E2|Reported Event|Test Product 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
8042|NCT02750345|E1|Reported Event|Test Product 1|10 mg Nitisinone Tablet
8043|NCT02750332|B1|Baseline|All Study Participants|
8044|NCT02750332|P2|Participant Flow|Treatment Sequence B (Fasted) - A (Fed)|"Subjects will receive a single 10 mg tablet of Nitisinone in treatment period 1 under fasting conditions, and 10 mg tablet of Nitisinone in treatment period 2 under fed conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered."
8071|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
20037|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
8045|NCT02750332|P1|Participant Flow|Treatment Sequence A (Fed) - B (Fasted)|"Subjects will receive a single 10 mg tablet of Nitisinone in treatment period 1 under fed conditions, and 10 mg tablet of Nitisinone in treatment period 2 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered."
8046|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
8047|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
8048|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
8049|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
8050|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
8051|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
8052|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
8053|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
8054|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
8055|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
8056|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
8057|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
8058|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
8059|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
8060|NCT02750332|E2|Reported Event|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
8061|NCT02750332|E1|Reported Event|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
8062|NCT02750267|B3|Baseline|Total|Total of all reporting groups
8063|NCT02750267|B2|Baseline|Group B- Closed-Loop Control Before Home Care|"Group B is identical to Group A with the exception that usual diabetes care (at home, using home insulin pump) will be evaluated after the Research House/Hotel admission. Subjects who are randomized to Group B will participate in CGM training and data collection after the Research House/Hotel admission. As with Group A, all subjects will use Diabetes Assistant (DiAs) with Closed-Loop during the admission.~Diabetes Assistant (DiAs) with Closed-Loop: All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours."
8064|NCT02750267|B1|Baseline|Group A- Home Care Before Closed-Loop Control|"In this randomized, cross-over study, the intervention involves blood glucose control using a Closed Loop system run by the Diabetes Assistant (DiAs) during a stay at a Research House/Hotel. All subjects will have blood glucose data compared between their usual diabetes care (at home, using home insulin pump) and this Closed-Loop care (at Research House/Hotel using the DiAs system). Subjects who are randomized to Group A will have home care evaluated before the Research House/Hotel admission. Subjects in this arm will participate in CGM training and data collection prior to the Research House/Hotel admission.~Diabetes Assistant (DiAs) with Closed-Loop: All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours."
8065|NCT02750267|P2|Participant Flow|Group B- Closed-Loop Control Before Home Care|"Group B is identical to Group A with the exception that usual diabetes care (at home, using home insulin pump) will be evaluated after the Research House/Hotel admission. Subjects who are randomized to Group B will participate in CGM training and data collection after the Research House/Hotel admission. As with Group A, all subjects will use Diabetes Assistant (DiAs) with Closed-Loop during the admission.~Diabetes Assistant (DiAs) with Closed-Loop: All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours."
8066|NCT02750267|P1|Participant Flow|Group A- Home Care Before Closed-Loop Control|"In this randomized, cross-over study, the intervention involves blood glucose control using a Closed Loop system run by the Diabetes Assistant (DiAs) during a stay at a Research House/Hotel. All subjects will have blood glucose data compared between their usual diabetes care (at home, using home insulin pump) and this Closed-Loop care (at Research House/Hotel using the DiAs system). Subjects who are randomized to Group A will have home care evaluated before the Research House/Hotel admission. Subjects in this arm will participate in CGM training and data collection prior to the Research House/Hotel admission.~Diabetes Assistant (DiAs) with Closed-Loop: All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours."
8067|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
8068|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
8069|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
8070|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
8433|NCT02741245|O1|Outcome|Ezetimibe 10 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
8072|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
8073|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
8074|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
8075|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
8076|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
8077|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
8078|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
8079|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
8080|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
8081|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
8082|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
8083|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
8084|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
8085|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
8086|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
8087|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
8088|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
8089|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
8090|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
8091|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
8092|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
8093|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
8478|NCT02741245|O1|Outcome|Ezetimibe 10 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
8094|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
8095|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
8096|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
8097|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
8098|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
8099|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
8100|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
8101|NCT02750267|E2|Reported Event|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
8102|NCT02750267|E1|Reported Event|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
8103|NCT02748213|B3|Baseline|Total|Total of all reporting groups
8104|NCT02748213|B2|Baseline|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
8105|NCT02748213|B1|Baseline|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
8106|NCT02748213|P2|Participant Flow|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
8107|NCT02748213|P1|Participant Flow|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via intravenous (IV) infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 milligrams per kilogram (mg/kg) in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 milligrams per meter-squared (mg/m^2), with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
8108|NCT02748213|O2|Outcome|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
8109|NCT02748213|O1|Outcome|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
8110|NCT02748213|O2|Outcome|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
8125|NCT02746809|O1|Outcome|CoreValve Evolut 34R TAVR System|"Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.~>~>~CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut 34R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)"
8553|NCT02739321|O1|Outcome|Baseline|All participants before they were randomized into arms.
8111|NCT02748213|O1|Outcome|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
8112|NCT02748213|O2|Outcome|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
8113|NCT02748213|O1|Outcome|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
8114|NCT02748213|O2|Outcome|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
8115|NCT02748213|O1|Outcome|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
8116|NCT02748213|O2|Outcome|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
8117|NCT02748213|O1|Outcome|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
8118|NCT02748213|O2|Outcome|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
8119|NCT02748213|O1|Outcome|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
8120|NCT02748213|E2|Reported Event|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
8121|NCT02748213|E1|Reported Event|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
8122|NCT02746809|B1|Baseline|CoreValve Evolut 34R TAVR System|"Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System. >~> CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components: >~Evolut 34R Transcatheter Aortic Valve (TAV) >~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath >~EnVeo R Loading System (LS)"
8123|NCT02746809|P1|Participant Flow|CoreValve Evolut R TAVR System 34R Valve|"The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut 34R Transcatheter Aortic Valve (TAV)~>~EnVeo R 20Fr Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)"
8124|NCT02746809|O1|Outcome|CoreValve Evolut 34R TAVR System|"Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.~>~>~CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut 34R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)"
20038|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
8126|NCT02746809|O1|Outcome|CoreValve Evolut 34R TAVR System|"Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.~>~>~CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut 34R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)"
8127|NCT02746809|O1|Outcome|CoreValve Evolut 34R TAVR System|"Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.~>~>~CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut 34R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)"
8128|NCT02746809|O1|Outcome|CoreValve Evolut 34R TAVR System|"Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.~>~>~CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut 34R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)"
8129|NCT02746809|O1|Outcome|CoreValve Evolut 34R TAVR System|"Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.~>~>~CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut 34R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)"
8130|NCT02746809|O1|Outcome|CoreValve Evolut 34R TAVR System|"Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.~>~>~CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut 34R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)"
8131|NCT02746809|O1|Outcome|CoreValve Evolut 34R TAVR System|"Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.~>~>~CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut 34R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)"
8132|NCT02746809|O1|Outcome|CoreValve Evolut 34R TAVR System|"Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.~>~>~CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut 34R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)"
8133|NCT02746809|O1|Outcome|CoreValve Evolut 34R TAVR System|"Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.~>~>~CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut 34R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)"
8134|NCT02746809|O1|Outcome|CoreValve Evolut 34R TAVR System|"Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.~>~>~CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut 34R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)"
8135|NCT02746809|O1|Outcome|CoreValve Evolut 34R TAVR System|"Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.~>~>~CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut 34R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)"
8136|NCT02746809|O1|Outcome|CoreValve Evolut 34R TAVR System|"Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.~>~>~CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut 34R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)"
8137|NCT02746809|O1|Outcome|CoreValve Evolut 34R TAVR System|"Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.~CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut 34R Transcatheter Aortic Valve (TAV)~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~EnVeo R Loading System (LS)"
8138|NCT02746809|O1|Outcome|CoreValve Evolut 34R TAVR System|Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.
8139|NCT02746809|E1|Reported Event|EVOLUTR 34R|Participants implanted with EVOLUTR 34R device
8140|NCT02746679|B3|Baseline|Total|Total of all reporting groups
8141|NCT02746679|B2|Baseline|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
8142|NCT02746679|B1|Baseline|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
8143|NCT02746679|P2|Participant Flow|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
8211|NCT02745626|O3|Outcome|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
8212|NCT02745626|O2|Outcome|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
8798|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
8144|NCT02746679|P1|Participant Flow|MBSR Group|"The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.~Mindfulness Based Stress Reduction: Mindfulness Based Stress Reduction programs have been shown to be effective, however, the potential benefits of Mindfulness Based Stress Reduction to decrease depression, anxiety, stress in other diseases. Therefore, the purpose of this"
8145|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
8146|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
8147|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
8148|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
8149|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
8150|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
8151|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
8152|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
8153|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
8154|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
8155|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
8156|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
8157|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
8213|NCT02745626|O1|Outcome|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
8158|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
8159|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
8160|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
8161|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
8162|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
8163|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
8164|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
8165|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
8166|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
8167|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
8168|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
8169|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
8170|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
8171|NCT02746679|E2|Reported Event|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
8214|NCT02745626|O3|Outcome|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
8215|NCT02745626|O2|Outcome|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
20039|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
8172|NCT02746679|E1|Reported Event|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
8173|NCT02746406|B1|Baseline|Peritron+|"SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter~Peritron+: Peritron+ device to measure intravesical pressure"
8174|NCT02746406|P1|Participant Flow|Peritron+|"SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter~Peritron+: Peritron+ device to measure intravesical pressure"
8175|NCT02746406|O1|Outcome|Peritron+|"SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter~Peritron+: Peritron+ device to measure intravesical pressure"
8176|NCT02746406|E1|Reported Event|Peritron+|"SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter~Peritron+: Peritron+ device to measure intravesical pressure"
8177|NCT02746107|B1|Baseline|All Participants|all participants in the study (968)
8178|NCT02746107|P1|Participant Flow|All Study Participants|all study participants were 968 (in all arms of this factorial RCT)
8179|NCT02746107|O5|Outcome|CHA2D2S-VASC Risk Score 5|
8180|NCT02746107|O4|Outcome|CHA2D2S-VASC Risk Score 4|
8181|NCT02746107|O3|Outcome|CHA2D2S-VASC Risk Score 3|
8182|NCT02746107|O2|Outcome|CHA2D2S-VASC Risk Score 2|
8183|NCT02746107|O1|Outcome|CHA2D2S-VASC Risk Score 1|
8184|NCT02746107|O2|Outcome|Prescription to Physician Himself|the participants had to imagine that they had atrial fibrillation, the risk from the diagram was theirs, and had to decide to take or not the OACs
8185|NCT02746107|O1|Outcome|Prescription to Patient|the participant physician were randomized to prescribe OAC to virtual patients
8186|NCT02746107|O2|Outcome|1 Year Risk Estimation on DA (CHA2D2S-VASC Score)|participants deciding to prescribe or not OAC after seeing the stroke risk estimation on 1 year (classical CHA2D2S-VASC score)
8187|NCT02746107|O1|Outcome|5 Years Risk Estimation on DA|participants had to prescribe or not OAC after seeing the risk estimated on 5 years
8188|NCT02746107|O2|Outcome|Two Diagrams|"classical decision aid with 2 diagrams (risk without treatment, and risk with treatment)~decision aid: decision aid with one/two diagrams"
8189|NCT02746107|O1|Outcome|One Diagram|"decision aid with one diagram (risk under treatment)~decision aid: decision aid with one/two diagrams"
8190|NCT02746107|E2|Reported Event|Two Diagrams|"classical decision aid with 2 diagrams (risk without treatment, and risk with treatment)~decision aid: decision aid with one/two diagrams~OAC prescribed: 406 of 482 (83.5%)"
8191|NCT02746107|E1|Reported Event|One Diagram|"decision aid with one diagram (risk under treatment)~decision aid: decision aid with one/two diagrams~OAC prescribed: 400 of 486 (83%)"
8192|NCT02745626|B4|Baseline|Total|Total of all reporting groups
8193|NCT02745626|B3|Baseline|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
8194|NCT02745626|B2|Baseline|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
8195|NCT02745626|B1|Baseline|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
8196|NCT02745626|P3|Participant Flow|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
8197|NCT02745626|P2|Participant Flow|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
8198|NCT02745626|P1|Participant Flow|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
8199|NCT02745626|O3|Outcome|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
8200|NCT02745626|O2|Outcome|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
8201|NCT02745626|O1|Outcome|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
8202|NCT02745626|O3|Outcome|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
8203|NCT02745626|O2|Outcome|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
8204|NCT02745626|O1|Outcome|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
8205|NCT02745626|O3|Outcome|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
8206|NCT02745626|O2|Outcome|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
8207|NCT02745626|O1|Outcome|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
8208|NCT02745626|O3|Outcome|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
8209|NCT02745626|O2|Outcome|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
8210|NCT02745626|O1|Outcome|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
12495|NCT02647320|O3|Outcome|DS-8500a 75 mg|Three DS-8500a 25 mg tablets and placebo
8220|NCT02745626|E3|Reported Event|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
8221|NCT02745626|E2|Reported Event|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
8222|NCT02745626|E1|Reported Event|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
8223|NCT02745392|B5|Baseline|Total|Total of all reporting groups
8224|NCT02745392|B4|Baseline|ZP-Zolmitriptan 3.8 mg|Double 1.9 mg patch administration
8225|NCT02745392|B3|Baseline|ZP-Zolmitriptan 1.9 mg|Single 1.9 mg patch administration
8226|NCT02745392|B2|Baseline|ZP-Zolmitriptan 1 mg|Single 1 mg patch administration
8227|NCT02745392|B1|Baseline|Placebo|Either single or double patch administration
8228|NCT02745392|P4|Participant Flow|ZP-Zolmitriptan 3.8 mg|"ZP-Zolmitriptan 3.8 mg (1.9 mg x 2 patches) single administration~ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system"
8229|NCT02745392|P3|Participant Flow|ZP-Zolmitriptan 1.9 mg|"ZP-Zolmitriptan 1.9 mg patch single administration~ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system"
8230|NCT02745392|P2|Participant Flow|ZP-Zolmitriptan 1 mg|"ZP-Zolmitriptan 1 mg patch single administration~ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system"
8231|NCT02745392|P1|Participant Flow|Placebo|"Placebo (either single or double patch) single administration~Placebo: Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches)"
8232|NCT02745392|O4|Outcome|ZP-Zolmitriptan 3.8 mg|"ZP-Zolmitriptan 3.8 mg (1.9 mg x 2 patches) single administration~ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system"
8233|NCT02745392|O3|Outcome|ZP-Zolmitriptan 1.9 mg|"ZP-Zolmitriptan 1.9 mg patch single administration~ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system"
8234|NCT02745392|O2|Outcome|ZP-Zolmitriptan 1 mg|"ZP-Zolmitriptan 1 mg patch single administration~ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system"
8235|NCT02745392|O1|Outcome|Placebo|"Placebo (either single or double patch) single administration~Placebo: Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches)"
8236|NCT02745392|O4|Outcome|ZP-Zolmitriptan 3.8 mg|"ZP-Zolmitriptan 3.8 mg (1.9 mg x 2 patches) single administration~ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system"
8237|NCT02745392|O3|Outcome|ZP-Zolmitriptan 1.9 mg|"ZP-Zolmitriptan 1.9 mg patch single administration~ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system"
8238|NCT02745392|O2|Outcome|ZP-Zolmitriptan 1 mg|"ZP-Zolmitriptan 1 mg patch single administration~ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system"
8239|NCT02745392|O1|Outcome|Placebo|"Placebo (either single or double patch) single administration~Placebo: Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches)"
8240|NCT02745392|E4|Reported Event|ZP-Zolmitriptan 3.8 mg|"ZP-Zolmitriptan 3.8 mg (1.9 mg x 2 patches) single administration~ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system"
8241|NCT02745392|E3|Reported Event|ZP-Zolmitriptan 1.9 mg|"ZP-Zolmitriptan 1.9 mg patch single administration~ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system"
8242|NCT02745392|E2|Reported Event|ZP-Zolmitriptan 1 mg|"ZP-Zolmitriptan 1 mg patch single administration~ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system"
8243|NCT02745392|E1|Reported Event|Placebo|"Placebo (either single or double patch) single administration~Placebo: Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches)"
8244|NCT02743962|B3|Baseline|Total|Total of all reporting groups
8245|NCT02743962|B2|Baseline|Therapeutic Wand Group|"This group received the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, and were also be provided with an intra-vaginal therapeutic wand and taught how to use it. They were then asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes.~Therapeutic Wand: The therapeutic wand was used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants followed a protocol of sweeping gently along one side then the other to find tender or tight areas, and then applied the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study."
8246|NCT02743962|B1|Baseline|Usual Physiotherapy Treatment Group|"This group received standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They were instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily. This continued for 6 weeks and a 6 week follow up period.~Routine physiotherapy control: Provision of routine physiotherapy care as control"
8247|NCT02743962|P2|Participant Flow|Therapeutic Wand Group|"This group received the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, and were also be provided with an intra-vaginal therapeutic wand and taught how to use it. They were then asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes.~Therapeutic Wand: The therapeutic wand was used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants followed a protocol of sweeping gently along one side then the other to find tender or tight areas, and then applied the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study."
8799|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
8248|NCT02743962|P1|Participant Flow|Usual Physiotherapy Treatment Group|"This group received standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They were instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily.~Routine physiotherapy control: Provision of routine physiotherapy care as control"
8249|NCT02743962|O2|Outcome|Therapeutic Wand Group|"This group will receive the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, but will also be provided with an intra-vaginal therapeutic wand and taught how to use it. They will then be asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes.~Therapeutic Wand: The therapeutic wand will be used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants will follow a protocol of sweeping gently along one side then the other to find tender or tight areas, and then to apply the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study."
8250|NCT02743962|O1|Outcome|Usual Physiotherapy Treatment Group|"This group will receive standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They will be instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily.~Routine physiotherapy control: Provision of routine physiotherapy care as control"
8251|NCT02743962|O1|Outcome|Therapeutic Wand Group|"This group received the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, and were also be provided with an intra-vaginal therapeutic wand and taught how to use it. They were then asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes.~Therapeutic Wand: The therapeutic wand was used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants followed a protocol of sweeping gently along one side then the other to find tender or tight areas, and then applied the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study."
8252|NCT02743962|O2|Outcome|Therapeutic Wand Group|"This group will receive the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, but will also be provided with an intra-vaginal therapeutic wand and taught how to use it. They will then be asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes.~Therapeutic Wand: The therapeutic wand will be used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants will follow a protocol of sweeping gently along one side then the other to find tender or tight areas, and then to apply the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study."
8253|NCT02743962|O1|Outcome|Usual Physiotherapy Treatment Group|"This group will receive standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They will be instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily.~Routine physiotherapy control: Provision of routine physiotherapy care as control"
8254|NCT02743962|O2|Outcome|Therapeutic Wand Group|"This group will receive the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, but will also be provided with an intra-vaginal therapeutic wand and taught how to use it. They will then be asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes.~Therapeutic Wand: The therapeutic wand will be used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants will follow a protocol of sweeping gently along one side then the other to find tender or tight areas, and then to apply the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study."
8255|NCT02743962|O1|Outcome|Usual Physiotherapy Treatment Group|"This group will receive standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They will be instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily.~Routine physiotherapy control: Provision of routine physiotherapy care as control"
8256|NCT02743962|O2|Outcome|Therapeutic Wand Group|"This group will receive the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, but will also be provided with an intra-vaginal therapeutic wand and taught how to use it. They will then be asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes.~Therapeutic Wand: The therapeutic wand will be used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants will follow a protocol of sweeping gently along one side then the other to find tender or tight areas, and then to apply the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study."
8257|NCT02743962|O1|Outcome|Usual Physiotherapy Treatment Group|"This group will receive standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They will be instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily.~Routine physiotherapy control: Provision of routine physiotherapy care as control"
8272|NCT02743936|O1|Outcome|NIPPV With Nasal Cannula|"Non-invasive positive pressure ventilation with nasal cannula in place~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
8273|NCT02743936|O2|Outcome|NIPPV Without Nasal Cannula|"Non-invasive positive pressure ventilation without nasal cannula~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
20040|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
8258|NCT02743962|O2|Outcome|Therapeutic Wand Group|"This group will receive the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, but will also be provided with an intra-vaginal therapeutic wand and taught how to use it. They will then be asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes.~Therapeutic Wand: The therapeutic wand will be used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants will follow a protocol of sweeping gently along one side then the other to find tender or tight areas, and then to apply the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study."
8259|NCT02743962|O1|Outcome|Usual Physiotherapy Treatment Group|"This group will receive standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They will be instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily.~Routine physiotherapy control: Provision of routine physiotherapy care as control"
8260|NCT02743962|O2|Outcome|Therapeutic Wand Group|"This group will receive the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, but will also be provided with an intra-vaginal therapeutic wand and taught how to use it. They will then be asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes.~Therapeutic Wand: The therapeutic wand will be used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants will follow a protocol of sweeping gently along one side then the other to find tender or tight areas, and then to apply the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study."
8261|NCT02743962|O1|Outcome|Usual Physiotherapy Treatment Group|"This group will receive standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They will be instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily.~Routine physiotherapy control: Provision of routine physiotherapy care as control"
8262|NCT02743962|O2|Outcome|Therapeutic Wand Group|"This group received the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, and were also be provided with an intra-vaginal therapeutic wand and taught how to use it. They were then asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes.~Therapeutic Wand: The therapeutic wand was used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants followed a protocol of sweeping gently along one side then the other to find tender or tight areas, and then applied the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study."
8263|NCT02743962|O1|Outcome|Usual Physiotherapy Treatment Group|"This group received standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They were instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily. This continued for 6 weeks and a 6 week follow up period.~Routine physiotherapy control: Provision of routine physiotherapy care as control"
8264|NCT02743962|E2|Reported Event|Therapeutic Wand Group|"This group received the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, and were also be provided with an intra-vaginal therapeutic wand and taught how to use it. They were then asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes.~Therapeutic Wand: The therapeutic wand was used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants followed a protocol of sweeping gently along one side then the other to find tender or tight areas, and then applied the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study."
8265|NCT02743962|E1|Reported Event|Usual Physiotherapy Treatment Group|"This group received standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They were instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily. This continued for 6 weeks and a 6 week follow up period.~Routine physiotherapy control: Provision of routine physiotherapy care as control"
8266|NCT02743936|B3|Baseline|Total|Total of all reporting groups
8267|NCT02743936|B2|Baseline|NIPPV Without Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) without nasal cannula first then NIPPV with nasal cannula~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
8268|NCT02743936|B1|Baseline|NIPPV With Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) with nasal cannula in place followed by NIPPV without nasal cannula in place.~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
8269|NCT02743936|P2|Participant Flow|NIPPV Without Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) without nasal cannula first then NIPPV with nasal cannula~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
8270|NCT02743936|P1|Participant Flow|NIPPV With Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) with nasal cannula in place followed by NIPPV without nasal cannula in place.~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
8271|NCT02743936|O2|Outcome|NIPPV Without Nasal Cannula|"Non-invasive positive pressure ventilation without nasal cannula~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
8321|NCT02743780|E10|Reported Event|Placebo Part 3|1 drop in each eye for 7 days
8274|NCT02743936|O1|Outcome|NIPPV With Nasal Cannula|"Non-invasive positive pressure ventilation with nasal cannula in place~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
8275|NCT02743936|E2|Reported Event|NIPPV Without Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) without nasal cannula first then NIPPV with nasal cannula~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
8276|NCT02743936|E1|Reported Event|NIPPV With Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) with nasal cannula in place followed by NIPPV without nasal cannula in place.~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
8277|NCT02743780|B6|Baseline|Total|Total of all reporting groups
8278|NCT02743780|B5|Baseline|Placebo|Placebo, 1 drop in the study eye (Part 1); 1 drop in each eye for 7 days (Part 2 and Part 3)
8279|NCT02743780|B4|Baseline|MGV354 0.3%|MGV354 ophthalmic suspension 0.3%, 1 drop in the study eye (Part 1)
8280|NCT02743780|B3|Baseline|MGV354 0.1%|MGV354 ophthalmic suspension 0.1%, 1 drop in the study eye (Part 1) or 1 drop in each eye for 7 days (Part 2 and Part 3)
8281|NCT02743780|B2|Baseline|MGV354 0.03%|MGV354 ophthalmic suspension 0.03%, 1 drop in the study eye (Part 1) or 1 drop in each eye for 7 days (Part 2)
8282|NCT02743780|B1|Baseline|MGV354 0.01%|MGV354 ophthalmic suspension 0.01%, 1 drop in the study eye (Part 1)
8283|NCT02743780|P5|Participant Flow|Placebo|Placebo, 1 drop in the study eye (Part 1); 1 drop in each eye for 7 days (Part 2 and Part 3)
8284|NCT02743780|P4|Participant Flow|MGV354 0.3%|MGV354 ophthalmic suspension 0.3%, 1 drop in the study eye (Part 1)
8285|NCT02743780|P3|Participant Flow|MGV354 0.1%|MGV354 ophthalmic suspension 0.1%, 1 drop in the study eye (Part 1) or 1 drop in each eye for 7 days (Part 2 and Part 3)
8286|NCT02743780|P2|Participant Flow|MGV354 0.03%|MGV354 ophthalmic suspension 0.03%, 1 drop in the study eye (Part 1) or 1 drop in each eye for 7 days (Part 2)
8287|NCT02743780|P1|Participant Flow|MGV354 0.01%|MGV354 ophthalmic suspension 0.01%, 1 drop in the study eye (Part 1)
8288|NCT02743780|O1|Outcome|MGV354 0.1%|Part 3: MGV354 0.1% ophthalmic suspension, MTD concentration determined from Part 2, 1 drop in each eye for 7 days
8289|NCT02743780|O2|Outcome|MGV354 0.1%|Part 2: MGV354 0.1% ophthalmic suspension, MTD concentration determined from Part 1, 1 drop in each eye for 7 days
8290|NCT02743780|O1|Outcome|MGV354 0.03%|Part 2: MGV354 0.03% ophthalmic suspension, next lowest dose from the maximum tolerated dose (MTD) concentration from Part 1, 1 drop in each eye for 7 days
8291|NCT02743780|O2|Outcome|MGV354 0.1%|Part 2: MGV354 0.1% ophthalmic suspension, MTD concentration determined from Part 1, 1 drop in each eye for 7 days
8292|NCT02743780|O1|Outcome|MGV354 0.03%|Part 2: MGV354 0.03% ophthalmic suspension, next lowest dose from the maximum tolerated dose (MTD) concentration from Part 1, 1 drop in each eye for 7 days
8293|NCT02743780|O2|Outcome|MGV354 0.1%|Part 2: MGV354 0.1% ophthalmic suspension, MTD concentration determined from Part 1, 1 drop in each eye for 7 days
8294|NCT02743780|O1|Outcome|MGV354 0.03%|Part 2: MGV354 0.03% ophthalmic suspension, next lowest dose from the maximum tolerated dose (MTD) concentration from Part 1, 1 drop in each eye for 7 days
8295|NCT02743780|O2|Outcome|MGV354 0.1%|Part 2: MGV354 0.1% ophthalmic suspension, MTD concentration determined from Part 1, 1 drop in each eye for 7 days
8296|NCT02743780|O1|Outcome|MGV354 0.03%|Part 2: MGV354 0.03% ophthalmic suspension, next lowest dose from the maximum tolerated dose (MTD) concentration from Part 1, 1 drop in each eye for 7 days
8297|NCT02743780|O3|Outcome|MGV354 0.3%|Part 1: MGV354 0.3% ophthalmic suspension, 1 drop in the study eye
8298|NCT02743780|O2|Outcome|MGV354 0.1%|Part 1: MGV354 0.1% ophthalmic suspension, 1 drop in the study eye
8299|NCT02743780|O1|Outcome|MGV354 0.03%|Part 1: MGV354 0.03% ophthalmic suspension, 1 drop in the study eye
8300|NCT02743780|O3|Outcome|MGV354 0.3%|Part 1: MGV354 0.3% ophthalmic suspension, 1 drop in the study eye
8301|NCT02743780|O2|Outcome|MGV354 0.1%|Part 1: MGV354 0.1% ophthalmic suspension, 1 drop in the study eye
8302|NCT02743780|O1|Outcome|MGV354 0.03%|Part 1: MGV354 0.03% ophthalmic suspension, 1 drop in the study eye
8303|NCT02743780|O3|Outcome|MGV354 0.3%|Part 1: MGV354 0.3% ophthalmic suspension, 1 drop in the study eye
8304|NCT02743780|O2|Outcome|MGV354 0.1%|Part 1: MGV354 0.1% ophthalmic suspension, 1 drop in the study eye
8305|NCT02743780|O1|Outcome|MGV354 0.03%|Part 1: MGV354 0.03% ophthalmic suspension, 1 drop in the study eye
8306|NCT02743780|O3|Outcome|MGV354 0.3%|Part 1: MGV354 0.3% ophthalmic suspension, 1 drop in the study eye
8307|NCT02743780|O2|Outcome|MGV354 0.1%|Part 1: MGV354 0.1% ophthalmic suspension, 1 drop in the study eye
8308|NCT02743780|O1|Outcome|MGV354 0.03%|Part 1: MGV354 0.03% ophthalmic suspension, 1 drop in the study eye
8309|NCT02743780|O3|Outcome|MGV354 0.3%|Part 1: MGV354 0.3% ophthalmic suspension, 1 drop in the study eye
8310|NCT02743780|O2|Outcome|MGV354 0.1%|Part 1: MGV354 0.1% ophthalmic suspension, 1 drop in the study eye
8311|NCT02743780|O1|Outcome|MGV354 0.03%|Part 1: MGV354 0.03% ophthalmic suspension, 1 drop in the study eye
8312|NCT02743780|O3|Outcome|MGV354 0.3%|Part 1: MGV354 0.3% ophthalmic suspension, 1 drop in the study eye
8313|NCT02743780|O2|Outcome|MGV354 0.1%|Part 1: MGV354 0.1% ophthalmic suspension, 1 drop in the study eye
8314|NCT02743780|O1|Outcome|MGV354 0.03%|Part 1: MGV354 0.03% ophthalmic suspension, 1 drop in the study eye
8315|NCT02743780|O2|Outcome|Placebo|Part 3: MGV354 placebo, 1 drop in each eye for 7 days
8316|NCT02743780|O1|Outcome|MGV354 0.1%|Part 3: MGV354 ophthalmic suspension, 1 drop in each eye for 7 days
8317|NCT02743780|O2|Outcome|Placebo|Part 3: MGV354 placebo, 1 drop in each eye for 7 days
8318|NCT02743780|O1|Outcome|MGV354 0.1%|Part 3: MGV354 ophthalmic suspension, 1 drop in each eye for 7 days
8319|NCT02743780|O2|Outcome|Placebo|Part 3: MGV354 placebo, 1 drop in each eye for 7 days
8320|NCT02743780|O1|Outcome|MGV354 0.1%|Part 3: MGV354 ophthalmic suspension, 1 drop in each eye for 7 days
8332|NCT02743702|B2|Baseline|GROUP RECEIVING THEIR USUAL THERAPIES|"This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies.~USUAL THERAPIES"
8333|NCT02743702|B1|Baseline|GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY|"Respiratory Physiotherapy sessions were held once a week by the physiotherapist, and four times more for the family at home, for one year. The sessions have a duration between 30-45 minutes, varying according to the level of patient cooperation. The exercise program should be repeated in three cycles, although younger children took longer than older in performing them.~RESPIRATORY PHYSIOTHERAPY: The protocol designed was composed of the following exercises:~supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times~lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side~sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing~diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his"
8334|NCT02743702|P2|Participant Flow|GROUP RECEIVING THEIR USUAL THERAPIES|"This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies.~USUAL THERAPIES"
8335|NCT02743702|P1|Participant Flow|GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY|"Respiratory Physiotherapy sessions were held once a week by the physiotherapist, and four times more for the family at home, for one year. The sessions have a duration between 30-45 minutes, varying according to the level of patient cooperation. The exercise program should be repeated in three cycles, although younger children took longer than older in performing them.~RESPIRATORY PHYSIOTHERAPY: The protocol designed was composed of the following exercises:~supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times~lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side~sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing~diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his"
8336|NCT02743702|O2|Outcome|GROUP RECEIVING THEIR USUAL THERAPIES|"This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies.~USUAL THERAPIES"
8337|NCT02743702|O1|Outcome|GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY|"Respiratory Physiotherapy sessions were held once a week by the physiotherapist, and four times more for the family at home, for one year. Sessions have a duration between 30-45 minutes, varying according to the level of patient cooperation. The exercise program should be repeated in three cycles, although younger children took longer than older in performing them.~RESPIRATORY PHYSIOTHERAPY: The protocol designed was composed of the following exercises:~supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times~lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side~sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing~diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his mou"
8338|NCT02743702|E2|Reported Event|GROUP RECEIVING THEIR USUAL THERAPIES|"This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies.~USUAL THERAPIES"
8339|NCT02743702|E1|Reported Event|GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY|"Respiratory Physiotherapy sessions were held once a week by the physiotherapist, and four times more for the family at home, for 1 year. The sessions have a duration between 30-45 minutes, varying according to the level of patient cooperation. The exercise program should be repeated in three cycles, although younger children took longer than older in performing them.~RESPIRATORY PHYSIOTHERAPY: The protocol designed was composed of the following exercises:~supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times~lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side~sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing~diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his mou"
8340|NCT02743117|B3|Baseline|Total|Total of all reporting groups
8341|NCT02743117|B2|Baseline|Monovalent Influenza Vaccine|Participants received a single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
8342|NCT02743117|B1|Baseline|Placebo|Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
8343|NCT02743117|P2|Participant Flow|Monovalent Influenza Vaccine|Participants received a single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
8344|NCT02743117|P1|Participant Flow|Placebo|Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
8345|NCT02743117|O2|Outcome|Monovalent Influenza Vaccine|Participants received a single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
8346|NCT02743117|O1|Outcome|Placebo|Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
8347|NCT02743117|O2|Outcome|Monovalent Influenza Vaccine|Participants received a single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
8348|NCT02743117|O1|Outcome|Placebo|Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
8349|NCT02743117|O2|Outcome|Monovalent Influenza Vaccine|Participants received a single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
8350|NCT02743117|O1|Outcome|Placebo|Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
8351|NCT02743117|O2|Outcome|Monovalent Influenza Vaccine|Participants received a single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
8352|NCT02743117|O1|Outcome|Placebo|Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
8353|NCT02743117|O2|Outcome|Monovalent Influenza Vaccine|Participants received a single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
8354|NCT02743117|O1|Outcome|Placebo|Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
8355|NCT02743117|E2|Reported Event|Monovalent Influenza Vaccine|Participants received a single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
8356|NCT02743117|E1|Reported Event|Placebo|Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
8357|NCT02742987|B3|Baseline|Total|Total of all reporting groups
8358|NCT02742987|B2|Baseline|Clopidogrel Group|"Clopidogrel 150 mg once daily + standard medical therapy~Clopidogrel: Clopidogrel 150 mg once daily~Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions"
8359|NCT02742987|B1|Baseline|Ticagrelor Group|"Ticagrelor 90 mg twice daily + standard medical therapy~Ticagrelor: Ticagrelor 90 mg twice daily~Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions"
8360|NCT02742987|P2|Participant Flow|Clopidogrel Group|"Clopidogrel 150 mg once daily + standard medical therapy~Clopidogrel: Clopidogrel 150 mg once daily~Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions"
8361|NCT02742987|P1|Participant Flow|Ticagrelor Group|"Ticagrelor 90 mg twice daily + standard medical therapy~Ticagrelor: Ticagrelor 90 mg twice daily~Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions"
8362|NCT02742987|O2|Outcome|Clopidogrel Group|"Clopidogrel 150 mg once daily + standard medical therapy~Clopidogrel: Clopidogrel 150 mg once daily~Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions"
8363|NCT02742987|O1|Outcome|Ticagrelor Group|"Ticagrelor 90 mg twice daily + standard medical therapy~Ticagrelor: Ticagrelor 90 mg twice daily~Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions"
8364|NCT02742987|E2|Reported Event|Clopidogrel Group|"Clopidogrel 150 mg once daily + standard medical therapy~Clopidogrel: Clopidogrel 150 mg once daily~Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions"
8365|NCT02742987|E1|Reported Event|Ticagrelor Group|"Ticagrelor 90 mg twice daily + standard medical therapy~Ticagrelor: Ticagrelor 90 mg twice daily~Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions"
8366|NCT02742818|B3|Baseline|Total|Total of all reporting groups
8367|NCT02742818|B2|Baseline|Upper Body Blanket|"Patients undergoing EVAR and LEA will use this type of warming blanket.~522 upper body blanket, Bair Hugger, 3M"
8368|NCT02742818|B1|Baseline|Underbody Blanket|"Patients undergoing EVAR and LEA will use this type of warming blanket.~635 full access underbody blanket, Bair Hugger, 3M"
8369|NCT02742818|P2|Participant Flow|Underbody Blanket|"Patients undergoing EVAR and LEA will use this type of warming blanket.~635 full access underbody blanket, Bair Hugger, 3M"
8370|NCT02742818|P1|Participant Flow|Upper Body Blanket|"Patients undergoing EVAR and LEA will use this type of warming blanket.~522 upper body blanket, Bair Hugger, 3M"
8371|NCT02742818|O2|Outcome|Underbody Blanket|"Patients undergoing EVAR and LEA will use this type of warming blanket.~635 full access underbody blanket, Bair Hugger, 3M"
8372|NCT02742818|O1|Outcome|Upper Body Blanket|"Patients undergoing EVAR and LEA will use this type of warming blanket.~522 upper body blanket, Bair Hugger, 3M"
8373|NCT02742818|O2|Outcome|Underbody Blanket|"Patients undergoing EVAR and LEA will use this type of warming blanket.~635 full access underbody blanket, Bair Hugger, 3M"
8374|NCT02742818|O1|Outcome|Upper Body Blanket|"Patients undergoing EVAR and LEA will use this type of warming blanket.~522 upper body blanket, Bair Hugger, 3M"
8375|NCT02742818|O2|Outcome|Upper Body Blanket|"Patients undergoing EVAR and LEA will use this type of warming blanket.~522 upper body blanket, Bair Hugger, 3M"
8376|NCT02742818|O1|Outcome|Underbody Blanket|"Patients undergoing EVAR and LEA will use this type of warming blanket.~635 full access underbody blanket, Bair Hugger, 3M"
8377|NCT02742818|O2|Outcome|Underbody Blanket|"Patients undergoing EVAR and LEA will use this type of warming blanket.~635 full access underbody blanket, Bair Hugger, 3M"
8378|NCT02742818|O1|Outcome|Upper Body Blanket|"Patients undergoing EVAR and LEA will use this type of warming blanket.~522 upper body blanket, Bair Hugger, 3M"
8379|NCT02742818|O2|Outcome|Underbody Blanket|"Patients undergoing EVAR and LEA will use this type of warming blanket.~635 full access underbody blanket, Bair Hugger, 3M"
8380|NCT02742818|O1|Outcome|Upper Body Blanket|"Patients undergoing EVAR and LEA will use this type of warming blanket.~522 upper body blanket, Bair Hugger, 3M"
8381|NCT02742818|E2|Reported Event|Underbody Blanket|"Patients undergoing EVAR and LEA will use this type of warming blanket.~635 full access underbody blanket, Bair Hugger, 3M"
8382|NCT02742818|E1|Reported Event|Upper Body Blanket|"Patients undergoing EVAR and LEA will use this type of warming blanket.~522 upper body blanket, Bair Hugger, 3M"
8383|NCT02741245|B6|Baseline|Total|Total of all reporting groups
8384|NCT02741245|B5|Baseline|Ezetimibe 10 mg+ Rosuvastatin 5.0 mg|1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
8385|NCT02741245|B4|Baseline|Ezetimibe 10 mg+ Rosuvastatin 2.5 mg|1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
8386|NCT02741245|B3|Baseline|Rosuvastatin 5.0 mg|2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
8389|NCT02741245|P5|Participant Flow|Ezetimibe 10 mg+ Rosuvastatin 5.0 mg|1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
8390|NCT02741245|P4|Participant Flow|Ezetimibe 10 mg+ Rosuvastatin 2.5 mg|1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
8391|NCT02741245|P3|Participant Flow|Rosuvastatin 5.0 mg|2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
8392|NCT02741245|P2|Participant Flow|Rosuvastatin 2.5 mg|1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
8393|NCT02741245|P1|Participant Flow|Ezetimibe 10 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
8394|NCT02741245|O5|Outcome|Ezetimibe 10 mg+ Rosuvastatin 5.0 mg|1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
8395|NCT02741245|O4|Outcome|Ezetimibe 10 mg+ Rosuvastatin 2.5 mg|1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
8396|NCT02741245|O3|Outcome|Rosuvastatin 5.0 mg|2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
8397|NCT02741245|O2|Outcome|Rosuvastatin 2.5 mg|1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
8398|NCT02741245|O1|Outcome|Ezetimibe 10 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
8399|NCT02741245|O5|Outcome|Ezetimibe 10 mg+ Rosuvastatin 5.0 mg|1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
8400|NCT02741245|O4|Outcome|Ezetimibe 10 mg+ Rosuvastatin 2.5 mg|1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
8401|NCT02741245|O3|Outcome|Rosuvastatin 5.0 mg|2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
8402|NCT02741245|O2|Outcome|Rosuvastatin 2.5 mg|1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
8403|NCT02741245|O1|Outcome|Ezetimibe 10 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
8404|NCT02741245|O5|Outcome|Ezetimibe 10 mg+ Rosuvastatin 5.0 mg|1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
8405|NCT02741245|O4|Outcome|Ezetimibe 10 mg+ Rosuvastatin 2.5 mg|1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
8406|NCT02741245|O3|Outcome|Rosuvastatin 5.0 mg|2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
8407|NCT02741245|O2|Outcome|Rosuvastatin 2.5 mg|1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
8408|NCT02741245|O1|Outcome|Ezetimibe 10 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
8409|NCT02741245|O5|Outcome|Ezetimibe 10 mg+ Rosuvastatin 5.0 mg|1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
8410|NCT02741245|O4|Outcome|Ezetimibe 10 mg+ Rosuvastatin 2.5 mg|1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
8411|NCT02741245|O3|Outcome|Rosuvastatin 5.0 mg|2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
8412|NCT02741245|O2|Outcome|Rosuvastatin 2.5 mg|1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
8413|NCT02741245|O1|Outcome|Ezetimibe 10 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
8414|NCT02741245|O5|Outcome|Ezetimibe 10 mg+ Rosuvastatin 5.0 mg|1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
8415|NCT02741245|O4|Outcome|Ezetimibe 10 mg+ Rosuvastatin 2.5 mg|1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
8416|NCT02741245|O3|Outcome|Rosuvastatin 5.0 mg|2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
8417|NCT02741245|O2|Outcome|Rosuvastatin 2.5 mg|1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
8418|NCT02741245|O1|Outcome|Ezetimibe 10 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
8419|NCT02741245|O5|Outcome|Ezetimibe 10 mg+ Rosuvastatin 5.0 mg|1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
8420|NCT02741245|O4|Outcome|Ezetimibe 10 mg+ Rosuvastatin 2.5 mg|1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
8421|NCT02741245|O3|Outcome|Rosuvastatin 5.0 mg|2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
8422|NCT02741245|O2|Outcome|Rosuvastatin 2.5 mg|1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
8423|NCT02741245|O1|Outcome|Ezetimibe 10 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
8424|NCT02741245|O5|Outcome|Ezetimibe 10 mg+ Rosuvastatin 5.0 mg|1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
8425|NCT02741245|O4|Outcome|Ezetimibe 10 mg+ Rosuvastatin 2.5 mg|1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
8426|NCT02741245|O3|Outcome|Rosuvastatin 5.0 mg|2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
8427|NCT02741245|O2|Outcome|Rosuvastatin 2.5 mg|1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
8428|NCT02741245|O1|Outcome|Ezetimibe 10 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
8429|NCT02741245|O5|Outcome|Ezetimibe 10 mg+ Rosuvastatin 5.0 mg|1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
8430|NCT02741245|O4|Outcome|Ezetimibe 10 mg+ Rosuvastatin 2.5 mg|1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
8431|NCT02741245|O3|Outcome|Rosuvastatin 5.0 mg|2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
8432|NCT02741245|O2|Outcome|Rosuvastatin 2.5 mg|1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
20041|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
8434|NCT02741245|O5|Outcome|Ezetimibe 10 mg+ Rosuvastatin 5.0 mg|1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
8435|NCT02741245|O4|Outcome|Ezetimibe 10 mg+ Rosuvastatin 2.5 mg|1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
8436|NCT02741245|O3|Outcome|Rosuvastatin 5.0 mg|2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
8437|NCT02741245|O2|Outcome|Rosuvastatin 2.5 mg|1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
8438|NCT02741245|O1|Outcome|Ezetimibe 10 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
8439|NCT02741245|O5|Outcome|Ezetimibe 10 mg+ Rosuvastatin 5.0 mg|1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
8440|NCT02741245|O4|Outcome|Ezetimibe 10 mg+ Rosuvastatin 2.5 mg|1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
8441|NCT02741245|O3|Outcome|Rosuvastatin 5.0 mg|2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
8442|NCT02741245|O2|Outcome|Rosuvastatin 2.5 mg|1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
8443|NCT02741245|O1|Outcome|Ezetimibe 10 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
8444|NCT02741245|O5|Outcome|Ezetimibe 10 mg+ Rosuvastatin 5.0 mg|1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
8445|NCT02741245|O4|Outcome|Ezetimibe 10 mg+ Rosuvastatin 2.5 mg|1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
8446|NCT02741245|O3|Outcome|Rosuvastatin 5.0 mg|2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
8447|NCT02741245|O2|Outcome|Rosuvastatin 2.5 mg|1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
8448|NCT02741245|O1|Outcome|Ezetimibe 10 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
8449|NCT02741245|O5|Outcome|Ezetimibe 10 mg+ Rosuvastatin 5.0 mg|1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
8450|NCT02741245|O4|Outcome|Ezetimibe 10 mg+ Rosuvastatin 2.5 mg|1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
8451|NCT02741245|O3|Outcome|Rosuvastatin 5.0 mg|2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
8452|NCT02741245|O2|Outcome|Rosuvastatin 2.5 mg|1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
8453|NCT02741245|O1|Outcome|Ezetimibe 10 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
8454|NCT02741245|O5|Outcome|Ezetimibe 10 mg+ Rosuvastatin 5.0 mg|1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
8455|NCT02741245|O4|Outcome|Ezetimibe 10 mg+ Rosuvastatin 2.5 mg|1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
8456|NCT02741245|O3|Outcome|Rosuvastatin 5.0 mg|2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
8457|NCT02741245|O2|Outcome|Rosuvastatin 2.5 mg|1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
8458|NCT02741245|O1|Outcome|Ezetimibe 10 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
8459|NCT02741245|O5|Outcome|Ezetimibe 10 mg+ Rosuvastatin 5.0 mg|1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
8460|NCT02741245|O4|Outcome|Ezetimibe 10 mg+ Rosuvastatin 2.5 mg|1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
8461|NCT02741245|O3|Outcome|Rosuvastatin 5.0 mg|2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
8462|NCT02741245|O2|Outcome|Rosuvastatin 2.5 mg|1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
8463|NCT02741245|O1|Outcome|Ezetimibe 10 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
8464|NCT02741245|O5|Outcome|Ezetimibe 10 mg+ Rosuvastatin 5.0 mg|1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
8465|NCT02741245|O4|Outcome|Ezetimibe 10 mg+ Rosuvastatin 2.5 mg|1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
8466|NCT02741245|O3|Outcome|Rosuvastatin 5.0 mg|2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
8467|NCT02741245|O2|Outcome|Rosuvastatin 2.5 mg|1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
8468|NCT02741245|O1|Outcome|Ezetimibe 10 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
8469|NCT02741245|O5|Outcome|Ezetimibe 10 mg+ Rosuvastatin 5.0 mg|1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
8470|NCT02741245|O4|Outcome|Ezetimibe 10 mg+ Rosuvastatin 2.5 mg|1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
8471|NCT02741245|O3|Outcome|Rosuvastatin 5.0 mg|2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
8472|NCT02741245|O2|Outcome|Rosuvastatin 2.5 mg|1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
8473|NCT02741245|O1|Outcome|Ezetimibe 10 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
8474|NCT02741245|O5|Outcome|Ezetimibe 10 mg+ Rosuvastatin 5.0 mg|1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
8475|NCT02741245|O4|Outcome|Ezetimibe 10 mg+ Rosuvastatin 2.5 mg|1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
8476|NCT02741245|O3|Outcome|Rosuvastatin 5.0 mg|2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
8477|NCT02741245|O2|Outcome|Rosuvastatin 2.5 mg|1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
12496|NCT02647320|O2|Outcome|DS-8500a 50 mg|Two DS-8500a 25 mg tablets and placebo
8479|NCT02741245|O5|Outcome|Ezetimibe 10 mg+ Rosuvastatin 5.0 mg|1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
8480|NCT02741245|O4|Outcome|Ezetimibe 10 mg+ Rosuvastatin 2.5 mg|1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
8481|NCT02741245|O3|Outcome|Rosuvastatin 5.0 mg|2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
8482|NCT02741245|O2|Outcome|Rosuvastatin 2.5 mg|1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
8483|NCT02741245|O1|Outcome|Ezetimibe 10 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
8484|NCT02741245|O5|Outcome|Ezetimibe 10 mg+ Rosuvastatin 5.0 mg|1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
8485|NCT02741245|O4|Outcome|Ezetimibe 10 mg+ Rosuvastatin 2.5 mg|1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
8486|NCT02741245|O3|Outcome|Rosuvastatin 5.0 mg|2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
8487|NCT02741245|O2|Outcome|Rosuvastatin 2.5 mg|1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
8488|NCT02741245|O1|Outcome|Ezetimibe 10 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
8489|NCT02741245|E5|Reported Event|Ezetimibe 10 mg+ Rosuvastatin 5.0 mg|1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
8490|NCT02741245|E4|Reported Event|Ezetimibe 10 mg+ Rosuvastatin 2.5 mg|1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
8491|NCT02741245|E3|Reported Event|Rosuvastatin 5.0 mg|2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
8492|NCT02741245|E2|Reported Event|Rosuvastatin 2.5 mg|1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
8493|NCT02741245|E1|Reported Event|Ezetimibe 10 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
8494|NCT02739698|B3|Baseline|Total|Total of all reporting groups
8495|NCT02739698|B2|Baseline|Hyperthermic (41-42ºC)|"Group 2, n=16 (hyperthermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in continuous hyperthermic perfusion (41-42ºC).~Paclitaxel~Radical surgery-peritonectomy (ovarian carcinomatosis)"
8496|NCT02739698|B1|Baseline|Normothermic (36-37ºC)|"Group 1, n=16(normothermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in room temperature (36-37ºC).~Paclitaxel~Radical surgery-peritonectomy (ovarian carcinomatosis)"
8497|NCT02739698|P2|Participant Flow|Hyperthermic (41-42ºC)|"Group 2, n=16 (hyperthermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in continuous hyperthermic perfusion (41-42ºC).~Paclitaxel~Radical surgery-peritonectomy (ovarian carcinomatosis)"
8498|NCT02739698|P1|Participant Flow|Normothermic (36-37ºC)|"Group 1, n=16(normothermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in room temperature (36-37ºC).~Paclitaxel~Radical surgery-peritonectomy (ovarian carcinomatosis)"
8499|NCT02739698|O2|Outcome|Hyperthermic (41-42ºC)|"Group 2, n=16 (hyperthermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in continuous hyperthermic perfusion (41-42ºC).~Paclitaxel~Radical surgery-peritonectomy"
8500|NCT02739698|O1|Outcome|Normothermic (36-37ºC)|"Group 1, n=16(normothermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in room temperature (36-37ºC).~Paclitaxel~Radical surgery-peritonectomy"
8501|NCT02739698|E2|Reported Event|Hyperthermic (41-42ºC)|"Group 2, n=16 (hyperthermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in continuous hyperthermic perfusion (41-42ºC).~Paclitaxel~Radical surgery-peritonectomy (ovarian carcinomatosis)"
8502|NCT02739698|E1|Reported Event|Normothermic (36-37ºC)|"Group 1, n=16(normothermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in room temperature (36-37ºC).~Paclitaxel~Radical surgery-peritonectomy (ovarian carcinomatosis)"
8503|NCT02739594|B3|Baseline|Total|Total of all reporting groups
8504|NCT02739594|B2|Baseline|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8505|NCT02739594|B1|Baseline|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8506|NCT02739594|P2|Participant Flow|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8507|NCT02739594|P1|Participant Flow|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute intravenous (IV) infusion as 6 milligrams (mg) every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8508|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8509|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8510|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8511|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8512|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8513|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8514|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8515|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8516|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8517|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8518|NCT02739594|O1|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8519|NCT02739594|O1|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8520|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8521|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8522|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8523|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8524|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8525|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8526|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8527|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8800|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
8528|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8529|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8530|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8531|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8532|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8533|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8534|NCT02739594|E2|Reported Event|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8535|NCT02739594|E1|Reported Event|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8536|NCT02739321|B3|Baseline|Total|Total of all reporting groups
8537|NCT02739321|B2|Baseline|Mattress Technology Turned Off|"Intervention: The first two weeks of the study there will be no intervention. The second two weeks of the study, the mattress technology will be turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.~Sound to Sleep System: The first two weeks of the study the sound to sleep system will be turned off, there will be no intervention. The second two weeks of the study the sound to sleep system will be turn on."
8538|NCT02739321|B1|Baseline|Mattress Technology On|"Intervention: The first two weeks of the study the mattress technology will be turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input. The second two weeks of the study, the mattress technology will be turned off, there will be no intervention.~Sound to Sleep System turned on: The first two weeks of the study the sound to sleep system will be turned on during this arm of the study. The second two weeks of the study, the sound to sleep system will be turned off, there will be no intervention."
8539|NCT02739321|P2|Participant Flow|Mattress Technology Turned Off Then On|"Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.~Sound to Sleep System: For the first two weeks of the study, the Sound to Sleep System is turned off, there is no intervention. For the second two weeks of the study, the Sound to Sleep System is turned on."
8540|NCT02739321|P1|Participant Flow|Mattress Technology On Then Off|"Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.~Sound to Sleep System turned on: For the first two weeks of the study, the sound to sleep system will be turned on during this arm of the study. For the second two weeks of the study, the Sound to Sleep System will be turned off, there is no intervention."
8541|NCT02739321|O2|Outcome|Mattress Technology Off|Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
8542|NCT02739321|O1|Outcome|Mattress Technology On|Participants who slept with the mattress technology turned on in either the first or second two weeks of the study.
8543|NCT02739321|O1|Outcome|Mattress Technology On|Participants who slept with the mattress technology turned on in either the first or second two weeks of the study.
8544|NCT02739321|O1|Outcome|All Participants|All participants in both the mattress technology on and off conditions.
8545|NCT02739321|O1|Outcome|Mattress Technology On|Participants who slept with the mattress technology turned on in either the first or second two weeks of the study.
8546|NCT02739321|O2|Outcome|Mattress Technology Off|Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
8547|NCT02739321|O1|Outcome|Mattress Technology On|Participants who slept with the mattress technology turned on in either the first or second two weeks of the study.
8548|NCT02739321|O3|Outcome|Mattress Technology Off|Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
8549|NCT02739321|O2|Outcome|Mattress Technology On|Participants who slept with the mattress technology turned on in either the first or second two weeks of the study.
8550|NCT02739321|O1|Outcome|Baseline|All participants before they were randomized into arms
8551|NCT02739321|O3|Outcome|Mattress Technology Off|Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
8552|NCT02739321|O2|Outcome|Mattress Technology On|Participants who slept with the mattress technology turned on in either the first or second two weeks of the study.
20042|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
8554|NCT02739321|O3|Outcome|Mattress Technology Off|Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
8555|NCT02739321|O2|Outcome|Mattress Technology On|Participants who slept with the mattress technology turned on in either the first or second two weeks of the study.
8556|NCT02739321|O1|Outcome|Baseline|All participants before they were randomized into arms
8557|NCT02739321|O3|Outcome|Mattress Technology Off|Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
8558|NCT02739321|O2|Outcome|Mattress Technology On|Participants who slept with the mattress technology turned on in either the first or second two weeks of the study.
8559|NCT02739321|O1|Outcome|Baseline|All participants before they were randomized into arms
8560|NCT02739321|O3|Outcome|Mattress Technonlogy Off|Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
8561|NCT02739321|O2|Outcome|Mattress Technology On|Participants who slept with the mattress technology turned on in either the first or second two weeks of the study.
8562|NCT02739321|O1|Outcome|Baseline|All participants before they were randomized into arms
8563|NCT02739321|O3|Outcome|Mattress Technology Off|Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
8564|NCT02739321|O2|Outcome|Mattress Technology On|Participants who slept with the mattress technology turned on in either the first or second two weeks of the study.
8565|NCT02739321|O1|Outcome|Baseline|All participants before they were randomized into arms
8566|NCT02739321|O3|Outcome|Mattress Technology Off|Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
8567|NCT02739321|O2|Outcome|Mattress Technology On|Participants who slept with the mattress technology turned on in either the first or second two weeks of the study.
8568|NCT02739321|O1|Outcome|Baseline|All participants before they were randomized into arms
8569|NCT02739321|O2|Outcome|Mattress Technology Off|Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
8570|NCT02739321|O1|Outcome|Mattress Technology On|Participants who slept with the mattress technology turned on in either the first or second two weeks of the study.
8571|NCT02739321|O2|Outcome|Mattress Technology Off|Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
8572|NCT02739321|O1|Outcome|Mattress Technology On|Participants who slept with the mattress technology turned on in either the first or second two weeks of the study.
8573|NCT02739321|O2|Outcome|Mattress Technology Off|Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
8574|NCT02739321|O1|Outcome|Mattress Technology On|Participants who slept with the mattress technology turned on in either the first or second two weeks of the study.
8575|NCT02739321|O2|Outcome|Mattress Technology Off|Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
8576|NCT02739321|O1|Outcome|Mattress Technology On|Participants who slept with the mattress technology turned on in either the first or second two weeks of the study.
8577|NCT02739321|O2|Outcome|Mattres Technology Off|Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
8578|NCT02739321|O1|Outcome|Mattress Technology On|Participants who slept with the mattress technology turned on in either the first or second two weeks of the study.
8579|NCT02739321|O2|Outcome|Mattress Technology Off Then On|"For the first two weeks of the study, the mattress technology is turned off, there is no intervention.~For the second two weeks of the study, the mattress technology is turned on~Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input."
8580|NCT02739321|O1|Outcome|Mattress Technology On Then Off|"For the first two weeks of the study, the mattress technology is turned on~For the second two weeks of the study, the mattress technology is turned off, there is no intervention.~Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input."
8581|NCT02739321|E2|Reported Event|Mattress Technology Off|The mattress technology is turned off, there is no intervention.
8582|NCT02739321|E1|Reported Event|Mattress Technology On|"The mattress technology will be turned on.~Intervention: The Sound to Sleep System is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input."
8583|NCT02738853|B1|Baseline|Medtronic Transcatheter Aortic Valve 2.0 Replacement System|"Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System~Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement."
8584|NCT02738853|P1|Participant Flow|Medtronic Transcatheter Aortic Valve 2.0 Replacement System|"Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System~Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement."
8585|NCT02738853|O1|Outcome|Medtronic Transcatheter Aortic Valve 2.0 Replacement System|"Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System~Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement."
8586|NCT02738853|O1|Outcome|Medtronic Transcatheter Aortic Valve 2.0 Replacement System|"Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System~Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement."
8587|NCT02738853|O1|Outcome|Medtronic Transcatheter Aortic Valve 2.0 Replacement System|"Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System~Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement."
8588|NCT02738853|O1|Outcome|Medtronic Transcatheter Aortic Valve 2.0 Replacement System|"Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System~Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement."
8589|NCT02738853|O1|Outcome|Medtronic Transcatheter Aortic Valve 2.0 Replacement System|"Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System~Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement."
8590|NCT02738853|O1|Outcome|Medtronic Transcatheter Aortic Valve 2.0 Replacement System|"Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System~Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement."
8591|NCT02738853|O1|Outcome|Medtronic Transcatheter Aortic Valve 2.0 Replacement System|"Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System~Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement."
8592|NCT02738853|O1|Outcome|Medtronic Transcatheter Aortic Valve 2.0 Replacement System|"Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System~Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement."
8593|NCT02738853|O1|Outcome|Medtronic Transcatheter Aortic Valve 2.0 Replacement System|"Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System~Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement."
8594|NCT02738853|O1|Outcome|Medtronic Transcatheter Aortic Valve 2.0 Replacement System|"Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System~Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement."
8595|NCT02738853|O1|Outcome|Medtronic Transcatheter Aortic Valve 2.0 Replacement System|"Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System~Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement."
8596|NCT02738853|O1|Outcome|Medtronic Transcatheter Aortic Valve 2.0 Replacement System|"Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System~Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement."
8597|NCT02738853|O1|Outcome|Medtronic Transcatheter Aortic Valve 2.0 Replacement System|"Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System~Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement."
8598|NCT02738853|E1|Reported Event|TAVR 2.0|Participants implanted with the TAVR 2.0 system
8599|NCT02738333|B4|Baseline|Total|Total of all reporting groups
8600|NCT02738333|B3|Baseline|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
8601|NCT02738333|B2|Baseline|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
8602|NCT02738333|B1|Baseline|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
8603|NCT02738333|P3|Participant Flow|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
8604|NCT02738333|P2|Participant Flow|SOF+RBV (Cohort 1)|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
8605|NCT02738333|P1|Participant Flow|LDV/SOF (Cohort 1)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks
8606|NCT02738333|O3|Outcome|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
8607|NCT02738333|O2|Outcome|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
8608|NCT02738333|O1|Outcome|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
8609|NCT02738333|O3|Outcome|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
8610|NCT02738333|O2|Outcome|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
8611|NCT02738333|O1|Outcome|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
8612|NCT02738333|O3|Outcome|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
8613|NCT02738333|O2|Outcome|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
8614|NCT02738333|O1|Outcome|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
8615|NCT02738333|O3|Outcome|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
8616|NCT02738333|O2|Outcome|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
8617|NCT02738333|O1|Outcome|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
8618|NCT02738333|O3|Outcome|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
20043|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
8619|NCT02738333|O2|Outcome|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
8620|NCT02738333|O1|Outcome|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
8621|NCT02738333|O3|Outcome|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
8622|NCT02738333|O2|Outcome|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
8623|NCT02738333|O1|Outcome|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
8624|NCT02738333|O3|Outcome|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
8625|NCT02738333|O2|Outcome|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
8626|NCT02738333|O1|Outcome|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
8627|NCT02738333|O3|Outcome|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
8628|NCT02738333|O2|Outcome|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
8629|NCT02738333|O1|Outcome|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
8630|NCT02738333|O3|Outcome|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
8631|NCT02738333|O2|Outcome|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
8632|NCT02738333|O1|Outcome|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
8633|NCT02738333|O3|Outcome|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
8634|NCT02738333|O2|Outcome|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
8635|NCT02738333|O1|Outcome|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
8636|NCT02738333|O3|Outcome|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
8637|NCT02738333|O2|Outcome|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
8638|NCT02738333|O1|Outcome|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
8639|NCT02738333|O3|Outcome|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
8640|NCT02738333|O2|Outcome|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
8641|NCT02738333|O1|Outcome|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
8642|NCT02738333|O3|Outcome|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
8643|NCT02738333|O2|Outcome|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
8644|NCT02738333|O1|Outcome|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
8645|NCT02738333|O3|Outcome|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
8646|NCT02738333|O2|Outcome|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
8647|NCT02738333|O1|Outcome|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
8648|NCT02738333|O3|Outcome|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
8649|NCT02738333|O2|Outcome|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
8650|NCT02738333|O1|Outcome|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
8651|NCT02738333|O3|Outcome|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
8652|NCT02738333|O2|Outcome|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
8653|NCT02738333|O1|Outcome|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
8654|NCT02738333|O3|Outcome|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
8655|NCT02738333|O2|Outcome|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
8656|NCT02738333|O1|Outcome|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
8657|NCT02738333|O3|Outcome|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
8658|NCT02738333|O2|Outcome|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
8659|NCT02738333|O1|Outcome|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
8660|NCT02738333|O3|Outcome|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
8661|NCT02738333|O2|Outcome|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
8662|NCT02738333|O1|Outcome|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
8663|NCT02738333|O3|Outcome|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
8664|NCT02738333|O2|Outcome|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
8665|NCT02738333|O1|Outcome|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
20044|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
8666|NCT02738333|O3|Outcome|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
8667|NCT02738333|O2|Outcome|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
8668|NCT02738333|O1|Outcome|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
8669|NCT02738333|O3|Outcome|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
8670|NCT02738333|O2|Outcome|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
8671|NCT02738333|O1|Outcome|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
8672|NCT02738333|O3|Outcome|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
8673|NCT02738333|O2|Outcome|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
8674|NCT02738333|O1|Outcome|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
8675|NCT02738333|E3|Reported Event|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
8676|NCT02738333|E2|Reported Event|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
8677|NCT02738333|E1|Reported Event|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
8678|NCT02738138|B3|Baseline|Total|Total of all reporting groups
8679|NCT02738138|B2|Baseline|ABT-493/ABT-530 for 12 Weeks|HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks
8680|NCT02738138|B1|Baseline|ABT-493/ABT-530 for 8 Weeks|HCV GT1-6/HIV-1 co-infected non-cirrhotic subjects treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks
8681|NCT02738138|P2|Participant Flow|ABT-493/ABT-530 for 12 Weeks|HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks
8682|NCT02738138|P1|Participant Flow|ABT-493/ABT-530 for 8 Weeks|HCV GT1-6/HIV-1 co-infected non-cirrhotic subjects treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks
8683|NCT02738138|O1|Outcome|ABT-493/ABT-530|HCV GT1-6/HIV-1 co-infected participants treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD)
8684|NCT02738138|O1|Outcome|ABT-493/ABT-530|HCV GT1-6/HIV-1 co-infected participants treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD)
8685|NCT02738138|O1|Outcome|ABT-493/ABT-530|HCV GT1-6/HIV-1 co-infected participants treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD)
8686|NCT02738138|E2|Reported Event|ABT-493/ABT-530 for 12 Weeks|HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis will be treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks
8687|NCT02738138|E1|Reported Event|ABT-493/ABT-530 for 8 Weeks|HCV GT1-6/HIV-1 co-infected non-cirrhotic subjects will be treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks
8688|NCT02737852|B1|Baseline|Healthy Subject|"Healthy subject exposed to Trojan Chameleon Personal Lubricant at least four times weekly for two weeks~Trojan Chameleon Personal Lubricant: silicone base with sensate"
8689|NCT02737852|P1|Participant Flow|Healthy Subject|"Healthy subject exposed to Trojan Chameleon Personal Lubricant at least four times weekly for two weeks~Trojan Chameleon Personal Lubricant: silicone base with sensate"
8690|NCT02737852|O1|Outcome|Healthy Subject|"Healthy subject exposed to Trojan Chameleon Personal Lubricant at least four times weekly for two weeks~Trojan Chameleon Personal Lubricant: silicone base with sensate"
8691|NCT02737852|O1|Outcome|Healthy Subject|"Healthy subject exposed to Trojan Chameleon Personal Lubricant at least four times weekly for two weeks~Trojan Chameleon Personal Lubricant: silicone base with sensate"
8692|NCT02737852|E1|Reported Event|Healthy Subject|"Healthy subject exposed to Trojan Chameleon Personal Lubricant at least four times weekly for two weeks~Trojan Chameleon Personal Lubricant: silicone base with sensate"
8693|NCT02737631|B1|Baseline|Healthy Subject|"Healthy subjects exposed to Trojan Chameleon personal lubricant via occlusive patch~Trojan Chameleon Personal Lubricant"
8694|NCT02737631|P1|Participant Flow|Healthy Subject|"Healthy subjects exposed to Trojan Chameleon personal lubricant via occlusive patch~Trojan Chameleon Personal Lubricant"
8695|NCT02737631|O1|Outcome|Healthy Subject|"Healthy subjects exposed to Trojan Chameleon personal lubricant via occlusive patch~Trojan Chameleon Personal Lubricant"
8696|NCT02737631|O1|Outcome|Healthy Subject|"Healthy subjects exposed to Trojan Chameleon personal lubricant via occlusive patch~Trojan Chameleon Personal Lubricant"
8697|NCT02737631|E1|Reported Event|Healthy Subject|"Healthy subjects exposed to Trojan Chameleon personal lubricant via occlusive patch~Trojan Chameleon Personal Lubricant"
8698|NCT02737618|B1|Baseline|Healthy Subject|"Healthy subjects exposed to Trojan Chameleon Personal Lubricant applied by occlusive patch~Trojan Chameleon Personal Lubricant: silicone base with sensate"
8699|NCT02737618|P1|Participant Flow|Healthy Subject|"Healthy subjects exposed to Trojan Chameleon Personal Lubricant applied by occlusive patch~Trojan Chameleon Personal Lubricant: silicone base with sensate"
8700|NCT02737618|O1|Outcome|Healthy Subject|"Healthy subjects exposed to Trojan Chameleon Personal Lubricant applied by occlusive patch~Trojan Chameleon Personal Lubricant: silicone base with sensate"
8701|NCT02737618|O1|Outcome|Healthy Subject|"Healthy subjects exposed to Trojan Chameleon Personal Lubricant applied by occlusive patch~Trojan Chameleon Personal Lubricant: silicone base with sensate"
8702|NCT02737618|E1|Reported Event|Healthy Subject|"Healthy subjects exposed to Trojan Chameleon Personal Lubricant applied by occlusive patch~Trojan Chameleon Personal Lubricant: silicone base with sensate"
8703|NCT02737592|B1|Baseline|Healthy Subject|"Healthy subject exposed to Trojan Simply Pleasures Personal Lubricant at least four times weekly for two weeks~Trojan Simply Pleasure Personal Lubricant: silicone base without sensate"
8704|NCT02737592|P1|Participant Flow|Healthy Subject|"Healthy subject exposed to Trojan Simply Pleasures Personal Lubricant at least four times weekly for two weeks~Trojan Simply Pleasure Personal Lubricant: silicone base without sensate"
20045|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
8705|NCT02737592|O1|Outcome|Healthy Subject|"Healthy subject exposed to Trojan Simply Pleasures Personal Lubricant at least four times weekly for two weeks~Trojan Simply Pleasure Personal Lubricant: silicone base without sensate"
8706|NCT02737592|O1|Outcome|Healthy Subject|"Healthy subject exposed to Trojan Simply Pleasures Personal Lubricant at least four times weekly for two weeks~Trojan Simply Pleasure Personal Lubricant: silicone base without sensate"
8707|NCT02737592|E1|Reported Event|Healthy Subject|"Healthy subject exposed to Trojan Simply Pleasures Personal Lubricant at least four times weekly for two weeks~Trojan Simply Pleasure Personal Lubricant: silicone base without sensate"
8708|NCT02736721|B1|Baseline|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
8709|NCT02736721|P1|Participant Flow|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544 (NCT number not available), NO16006 (NCT number not available) or ML17228 (NCT number not available) and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 microgram (mcg) once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
8710|NCT02736721|O1|Outcome|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
8711|NCT02736721|O1|Outcome|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
8712|NCT02736721|O1|Outcome|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
8713|NCT02736721|O1|Outcome|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
8714|NCT02736721|O1|Outcome|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
8715|NCT02736721|O1|Outcome|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
8716|NCT02736721|E1|Reported Event|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
8717|NCT02736175|B3|Baseline|Total|Total of all reporting groups
8718|NCT02736175|B2|Baseline|Placebo Vehicle|PV (placebo drug delivery vehicle)
8719|NCT02736175|B1|Baseline|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
8720|NCT02736175|P2|Participant Flow|Placebo Vehicle|PV (placebo drug delivery vehicle)
8721|NCT02736175|P1|Participant Flow|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
8722|NCT02736175|O2|Outcome|Placebo Vehicle|PV (placebo drug delivery vehicle)
8723|NCT02736175|O1|Outcome|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
8724|NCT02736175|O2|Outcome|Placebo Vehicle|PV (placebo drug delivery vehicle)
8725|NCT02736175|O1|Outcome|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
8726|NCT02736175|E2|Reported Event|Placebo Vehicle|PV (placebo drug delivery vehicle)
8727|NCT02736175|E1|Reported Event|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
8728|NCT02735200|B3|Baseline|Total|Total of all reporting groups
8729|NCT02735200|B2|Baseline|Application of Aloe Vera Gel|Intervention: aloe vera gel administration 1 gram
8730|NCT02735200|B1|Baseline|Topical Application of Vitamin D3|this arm received topical vitamin D3 1gram (5000IU)
8731|NCT02735200|P2|Participant Flow|Topical Application of Vitamin D3|topical vitamin D3 in intervention group: local application of Top-D, 1 gram (5000 IU) was applied every day, for 120 days.
8732|NCT02735200|P1|Participant Flow|Application of Aloe Vera Gel|Intervention: aloe vera gel administration was applied 1 gram daily for 120 days.
8733|NCT02735200|O2|Outcome|Application of Aloe Vera Gel|Intervention: aloe vera gel administration
8734|NCT02735200|O1|Outcome|Topical Application of Vitamin D3|"Intervention: patients will be administered topical vitamin D3 5000 IU~topical vitamin D3 in intervention group: local application"
8735|NCT02735200|E2|Reported Event|Application of Aloe Vera Gel|"Intervention: aloe vera gel administration~topical vitamin D3 in intervention group: local application"
8736|NCT02735200|E1|Reported Event|Topical Application of Vitamin D3|"Intervention: patients will be administered topical vitamin D3 5000 IU~topical vitamin D3 in intervention group: local application"
8737|NCT02734940|B3|Baseline|Total|Total of all reporting groups
8801|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
8802|NCT02734355|E2|Reported Event|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
8803|NCT02734355|E1|Reported Event|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
8738|NCT02734940|B2|Baseline|Lidocaine, Dexmedetomidine and Ketamine|Will receive pre-operative spinal duramorph (4mcg/kg up to max dose of 300mcg), intra-operative intravenous (iv) infusion of Ketamine (0.4 mg/kg/hr), Lidocaine (20 mcg/kg/min) and Dexmedetomidine (0.25 mcg/kg/hr) started after induction of General Anesthesia and maintained through the Cardiopulmonary Bypass (CPB) towards the end of surgery. At this point all infusions will be turned off except Dexmedetomidine. The total intraoperative fentanyl dose will be limited to <250mcg (or 3mcg/kg) and total midazolam to ≤ 2mg in the study group.
8739|NCT02734940|B1|Baseline|Unrestricted Fentanyl|"Will receive injection of sterile saline (2cc) in lower back area (to minimize participant bias) and unrestricted amount of intraoperative opioids (fentanyl) at the discretion of the Anesthesiologist.~Both groups will receive General Anesthesia with volatile agents and single dose of iv Tylenol intraoperatively. Both groups of patients will be transported to Intensive Care Unit (ICU) on Dexmedetomidine (dose range 0.25 – 0.7 mcg/kg/hr). Dose titration is based on sedation level and hemodynamic goals set by Cardiac Anesthesiologist.~Unrestricted Fentanyl: No changes to current practices, using unlimited narcotic medications intraoperatively."
8740|NCT02734940|P2|Participant Flow|Lidocaine, Dexmedetomidine and Ketamine|Will receive pre-operative spinal duramorph (4mcg/kg up to max dose of 300mcg), intra-operative intravenous (iv) infusion of Ketamine (0.4 mg/kg/hr), Lidocaine (20 mcg/kg/min) and Dexmedetomidine (0.25 mcg/kg/hr) started after induction of General Anesthesia and maintained through the Cardiopulmonary Bypass (CPB) towards the end of surgery. At this point all infusions will be turned off except Dexmedetomidine. The total intraoperative fentanyl dose will be limited to <250mcg (or 3mcg/kg) and total midazolam to ≤ 2mg in the study group.
8741|NCT02734940|P1|Participant Flow|Unrestricted Fentanyl|"Will receive injection of sterile saline (2cc) in lower back area (to minimize participant bias) and unrestricted amount of intraoperative opioids (fentanyl) at the discretion of the Anesthesiologist.~Both groups will receive General Anesthesia with volatile agents and single dose of iv Tylenol intraoperatively. Both groups of patients will be transported to Intensive Care Unit (ICU) on Dexmedetomidine (dose range 0.25 – 0.7 mcg/kg/hr). Dose titration is based on sedation level and hemodynamic goals set by Cardiac Anesthesiologist.~Unrestricted Fentanyl: No changes to current practices, using unlimited narcotic medications intraoperatively."
8742|NCT02734940|O2|Outcome|Lidocaine, Dexmedetomidine and Ketamine|Will receive pre-operative spinal duramorph (4mcg/kg up to max dose of 300mcg), intra-operative intravenous (iv) infusion of Ketamine (0.4 mg/kg/hr), Lidocaine (20 mcg/kg/min) and Dexmedetomidine (0.25 mcg/kg/hr) started after induction of General Anesthesia and maintained through the Cardiopulmonary Bypass (CPB) towards the end of surgery. At this point all infusions will be turned off except Dexmedetomidine. The total intraoperative fentanyl dose will be limited to <250mcg (or 3mcg/kg) and total midazolam to ≤ 2mg in the study group.
8743|NCT02734940|O1|Outcome|Unrestricted Fentanyl|"Will receive injection of sterile saline (2cc) in lower back area (to minimize participant bias) and unrestricted amount of intraoperative opioids (fentanyl) at the discretion of the Anesthesiologist.~Both groups will receive General Anesthesia with volatile agents and single dose of iv Tylenol intraoperatively. Both groups of patients will be transported to Intensive Care Unit (ICU) on Dexmedetomidine (dose range 0.25 – 0.7 mcg/kg/hr). Dose titration is based on sedation level and hemodynamic goals set by Cardiac Anesthesiologist.~Unrestricted Fentanyl: No changes to current practices, using unlimited narcotic medications intraoperatively."
8744|NCT02734940|O2|Outcome|Lidocaine, Dexmedetomidine and Ketamine|Will receive pre-operative spinal duramorph (4mcg/kg up to max dose of 300mcg), intra-operative intravenous (iv) infusion of Ketamine (0.4 mg/kg/hr), Lidocaine (20 mcg/kg/min) and Dexmedetomidine (0.25 mcg/kg/hr) started after induction of General Anesthesia and maintained through the Cardiopulmonary Bypass (CPB) towards the end of surgery. At this point all infusions will be turned off except Dexmedetomidine. The total intraoperative fentanyl dose will be limited to <250mcg (or 3mcg/kg) and total midazolam to ≤ 2mg in the study group.
8745|NCT02734940|O1|Outcome|Unrestricted Fentanyl|"Will receive injection of sterile saline (2cc) in lower back area (to minimize participant bias) and unrestricted amount of intraoperative opioids (fentanyl) at the discretion of the Anesthesiologist.~Both groups will receive General Anesthesia with volatile agents and single dose of iv Tylenol intraoperatively. Both groups of patients will be transported to Intensive Care Unit (ICU) on Dexmedetomidine (dose range 0.25 – 0.7 mcg/kg/hr). Dose titration is based on sedation level and hemodynamic goals set by Cardiac Anesthesiologist.~Unrestricted Fentanyl: No changes to current practices, using unlimited narcotic medications intraoperatively."
8746|NCT02734940|O2|Outcome|Lidocaine, Dexmedetomidine and Ketamine|Will receive pre-operative spinal duramorph (4mcg/kg up to max dose of 300mcg), intra-operative intravenous (iv) infusion of Ketamine (0.4 mg/kg/hr), Lidocaine (20 mcg/kg/min) and Dexmedetomidine (0.25 mcg/kg/hr) started after induction of General Anesthesia and maintained through the Cardiopulmonary Bypass (CPB) towards the end of surgery. At this point all infusions will be turned off except Dexmedetomidine. The total intraoperative fentanyl dose will be limited to <250mcg (or 3mcg/kg) and total midazolam to ≤ 2mg in the study group.
8747|NCT02734940|O1|Outcome|Unrestricted Fentanyl|"Will receive injection of sterile saline (2cc) in lower back area (to minimize participant bias) and unrestricted amount of intraoperative opioids (fentanyl) at the discretion of the Anesthesiologist.~Both groups will receive General Anesthesia with volatile agents and single dose of iv Tylenol intraoperatively. Both groups of patients will be transported to Intensive Care Unit (ICU) on Dexmedetomidine (dose range 0.25 – 0.7 mcg/kg/hr). Dose titration is based on sedation level and hemodynamic goals set by Cardiac Anesthesiologist.~Unrestricted Fentanyl: No changes to current practices, using unlimited narcotic medications intraoperatively."
8748|NCT02734940|O2|Outcome|Lidocaine, Dexmedetomidine and Ketamine|Will receive pre-operative spinal duramorph (4mcg/kg up to max dose of 300mcg), intra-operative intravenous (iv) infusion of Ketamine (0.4 mg/kg/hr), Lidocaine (20 mcg/kg/min) and Dexmedetomidine (0.25 mcg/kg/hr) started after induction of General Anesthesia and maintained through the Cardiopulmonary Bypass (CPB) towards the end of surgery. At this point all infusions will be turned off except Dexmedetomidine. The total intraoperative fentanyl dose will be limited to <250mcg (or 3mcg/kg) and total midazolam to ≤ 2mg in the study group.
8804|NCT02734212|B3|Baseline|Total|Total of all reporting groups
8805|NCT02734212|B2|Baseline|Enhanced Treatment as Usual|The comparison condition will consist of providing a pamphlet that discusses societal stigma and internalized stigma, and provides resources to help combat the effects of both. Participants will be given the informational pamphlet and study staff will discuss its content with the participant.
20046|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
8749|NCT02734940|O1|Outcome|Unrestricted Fentanyl|"Will receive injection of sterile saline (2cc) in lower back area (to minimize participant bias) and unrestricted amount of intraoperative opioids (fentanyl) at the discretion of the Anesthesiologist.~Both groups will receive General Anesthesia with volatile agents and single dose of iv Tylenol intraoperatively. Both groups of patients will be transported to Intensive Care Unit (ICU) on Dexmedetomidine (dose range 0.25 – 0.7 mcg/kg/hr). Dose titration is based on sedation level and hemodynamic goals set by Cardiac Anesthesiologist.~Unrestricted Fentanyl: No changes to current practices, using unlimited narcotic medications intraoperatively."
8750|NCT02734940|O2|Outcome|Lidocaine, Dexmedetomidine and Ketamine|Will receive pre-operative spinal duramorph (4mcg/kg up to max dose of 300mcg), intra-operative intravenous (iv) infusion of Ketamine (0.4 mg/kg/hr), Lidocaine (20 mcg/kg/min) and Dexmedetomidine (0.25 mcg/kg/hr) started after induction of General Anesthesia and maintained through the Cardiopulmonary Bypass (CPB) towards the end of surgery. At this point all infusions will be turned off except Dexmedetomidine. The total intraoperative fentanyl dose will be limited to <250mcg (or 3mcg/kg) and total midazolam to ≤ 2mg in the study group.
8751|NCT02734940|O1|Outcome|Unrestricted Fentanyl|"Will receive injection of sterile saline (2cc) in lower back area (to minimize participant bias) and unrestricted amount of intraoperative opioids (fentanyl) at the discretion of the Anesthesiologist.~Both groups will receive General Anesthesia with volatile agents and single dose of iv Tylenol intraoperatively. Both groups of patients will be transported to Intensive Care Unit (ICU) on Dexmedetomidine (dose range 0.25 – 0.7 mcg/kg/hr). Dose titration is based on sedation level and hemodynamic goals set by Cardiac Anesthesiologist.~Unrestricted Fentanyl: No changes to current practices, using unlimited narcotic medications intraoperatively."
8752|NCT02734940|O2|Outcome|Lidocaine, Dexmedetomidine and Ketamine|Will receive pre-operative spinal duramorph (4mcg/kg up to max dose of 300mcg), intra-operative intravenous (iv) infusion of Ketamine (0.4 mg/kg/hr), Lidocaine (20 mcg/kg/min) and Dexmedetomidine (0.25 mcg/kg/hr) started after induction of General Anesthesia and maintained through the Cardiopulmonary Bypass (CPB) towards the end of surgery. At this point all infusions will be turned off except Dexmedetomidine. The total intraoperative fentanyl dose will be limited to <250mcg (or 3mcg/kg) and total midazolam to ≤ 2mg in the study group.
8753|NCT02734940|O1|Outcome|Unrestricted Fentanyl|"Will receive injection of sterile saline (2cc) in lower back area (to minimize participant bias) and unrestricted amount of intraoperative opioids (fentanyl) at the discretion of the Anesthesiologist.~Both groups will receive General Anesthesia with volatile agents and single dose of iv Tylenol intraoperatively. Both groups of patients will be transported to Intensive Care Unit (ICU) on Dexmedetomidine (dose range 0.25 – 0.7 mcg/kg/hr). Dose titration is based on sedation level and hemodynamic goals set by Cardiac Anesthesiologist.~Unrestricted Fentanyl: No changes to current practices, using unlimited narcotic medications intraoperatively."
8754|NCT02734940|O2|Outcome|Lidocaine, Dexmedetomidine and Ketamine|Will receive pre-operative spinal duramorph (4mcg/kg up to max dose of 300mcg), intra-operative intravenous (iv) infusion of Ketamine (0.4 mg/kg/hr), Lidocaine (20 mcg/kg/min) and Dexmedetomidine (0.25 mcg/kg/hr) started after induction of General Anesthesia and maintained through the Cardiopulmonary Bypass (CPB) towards the end of surgery. At this point all infusions will be turned off except Dexmedetomidine. The total intraoperative fentanyl dose will be limited to <250mcg (or 3mcg/kg) and total midazolam to ≤ 2mg in the study group.
8755|NCT02734940|O1|Outcome|Unrestricted Fentanyl|"Will receive injection of sterile saline (2cc) in lower back area (to minimize participant bias) and unrestricted amount of intraoperative opioids (fentanyl) at the discretion of the Anesthesiologist.~Both groups will receive General Anesthesia with volatile agents and single dose of iv Tylenol intraoperatively. Both groups of patients will be transported to Intensive Care Unit (ICU) on Dexmedetomidine (dose range 0.25 – 0.7 mcg/kg/hr). Dose titration is based on sedation level and hemodynamic goals set by Cardiac Anesthesiologist.~Unrestricted Fentanyl: No changes to current practices, using unlimited narcotic medications intraoperatively."
8756|NCT02734940|O2|Outcome|Lidocaine, Dexmedetomidine and Ketamine|Will receive pre-operative spinal duramorph (4mcg/kg up to max dose of 300mcg), intra-operative intravenous (iv) infusion of Ketamine (0.4 mg/kg/hr), Lidocaine (20 mcg/kg/min) and Dexmedetomidine (0.25 mcg/kg/hr) started after induction of General Anesthesia and maintained through the Cardiopulmonary Bypass (CPB) towards the end of surgery. At this point all infusions will be turned off except Dexmedetomidine. The total intraoperative fentanyl dose will be limited to <250mcg (or 3mcg/kg) and total midazolam to ≤ 2mg in the study group.
8757|NCT02734940|O1|Outcome|Unrestricted Fentanyl|"Will receive injection of sterile saline (2cc) in lower back area (to minimize participant bias) and unrestricted amount of intraoperative opioids (fentanyl) at the discretion of the Anesthesiologist.~Both groups will receive General Anesthesia with volatile agents and single dose of iv Tylenol intraoperatively. Both groups of patients will be transported to Intensive Care Unit (ICU) on Dexmedetomidine (dose range 0.25 – 0.7 mcg/kg/hr). Dose titration is based on sedation level and hemodynamic goals set by Cardiac Anesthesiologist.~Unrestricted Fentanyl: No changes to current practices, using unlimited narcotic medications intraoperatively."
8758|NCT02734940|O2|Outcome|Lidocaine, Dexmedetomidine and Ketamine|Will receive pre-operative spinal duramorph (4mcg/kg up to max dose of 300mcg), intra-operative intravenous (iv) infusion of Ketamine (0.4 mg/kg/hr), Lidocaine (20 mcg/kg/min) and Dexmedetomidine (0.25 mcg/kg/hr) started after induction of General Anesthesia and maintained through the Cardiopulmonary Bypass (CPB) towards the end of surgery. At this point all infusions will be turned off except Dexmedetomidine. The total intraoperative fentanyl dose will be limited to <250mcg (or 3mcg/kg) and total midazolam to ≤ 2mg in the study group.
8759|NCT02734940|O1|Outcome|Unrestricted Fentanyl|"Will receive injection of sterile saline (2cc) in lower back area (to minimize participant bias) and unrestricted amount of intraoperative opioids (fentanyl) at the discretion of the Anesthesiologist.~Both groups will receive General Anesthesia with volatile agents and single dose of iv Tylenol intraoperatively. Both groups of patients will be transported to Intensive Care Unit (ICU) on Dexmedetomidine (dose range 0.25 – 0.7 mcg/kg/hr). Dose titration is based on sedation level and hemodynamic goals set by Cardiac Anesthesiologist.~Unrestricted Fentanyl: No changes to current practices, using unlimited narcotic medications intraoperatively."
8829|NCT02732899|P2|Participant Flow|Group 2|"Intravitreal injection of EYLEA® (aflibercept) will be given at baseline, week 8, 16, 24 and 32. Sham injections will be given at week 1, 4, 12, 20, and 28 in order to maintain masking of patient to treatment assignment~EYLEA"
9172|NCT02723201|E4|Reported Event|Part 1: TAK-020 17.5 mg IRT|TAK-020 17.5 mg, IRT, orally under fasted state, once on Day 1 of fourth intervention period.
8760|NCT02734940|E2|Reported Event|Lidocaine, Dexmedetomidine and Ketamine|Will receive pre-operative spinal duramorph (4mcg/kg up to max dose of 300mcg), intra-operative intravenous (iv) infusion of Ketamine (0.4 mg/kg/hr), Lidocaine (20 mcg/kg/min) and Dexmedetomidine (0.25 mcg/kg/hr) started after induction of General Anesthesia and maintained through the Cardiopulmonary Bypass (CPB) towards the end of surgery. At this point all infusions will be turned off except Dexmedetomidine. The total intraoperative fentanyl dose will be limited to <250mcg (or 3mcg/kg) and total midazolam to ≤ 2mg in the study group.
8761|NCT02734940|E1|Reported Event|Unrestricted Fentanyl|"Will receive injection of sterile saline (2cc) in lower back area (to minimize participant bias) and unrestricted amount of intraoperative opioids (fentanyl) at the discretion of the Anesthesiologist.~Both groups will receive General Anesthesia with volatile agents and single dose of iv Tylenol intraoperatively. Both groups of patients will be transported to Intensive Care Unit (ICU) on Dexmedetomidine (dose range 0.25 – 0.7 mcg/kg/hr). Dose titration is based on sedation level and hemodynamic goals set by Cardiac Anesthesiologist.~Unrestricted Fentanyl: No changes to current practices, using unlimited narcotic medications intraoperatively."
8762|NCT02734810|B3|Baseline|Total|Total of all reporting groups
8763|NCT02734810|B2|Baseline|Part B|"Liprotamase Powder for Oral Solution in Subjects aged 28 days to <7 years~Liprotamase Powder for Oral Solution: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy"
8764|NCT02734810|B1|Baseline|Part A|"Liprotamase Powder for Oral Solution in Subjects aged ≥7 years of age~Liprotamase Powder for Oral Solution: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy"
8765|NCT02734810|P2|Participant Flow|Part B|"Liprotamase Powder for Oral Solution in Subjects aged 28 days to <7 years~Liprotamase Powder for Oral Solution: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy"
8766|NCT02734810|P1|Participant Flow|Part A|"Liprotamase Powder for Oral Solution in Subjects aged ≥7 years of age~Liprotamase Powder for Oral Solution: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy"
8767|NCT02734810|O2|Outcome|Part B|"Liprotamase Powder for Oral Solution in Subjects aged 28 days to <7 years~Liprotamase Powder for Oral Solution: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy"
8768|NCT02734810|O1|Outcome|Part A|"Liprotamase Powder for Oral Solution in Subjects aged ≥7 years of age~Liprotamase Powder for Oral Solution: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy"
8769|NCT02734810|E2|Reported Event|Part B|"Liprotamase Powder for Oral Solution in Subjects aged 28 days to <7 years~Liprotamase Powder for Oral Solution: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy"
8770|NCT02734810|E1|Reported Event|Part A|"Liprotamase Powder for Oral Solution in Subjects aged ≥7 years of age~Liprotamase Powder for Oral Solution: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy"
8771|NCT02734355|B3|Baseline|Total|Total of all reporting groups
8772|NCT02734355|B2|Baseline|Placebo|"Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days~Placebo (for telmisartan and amlodipine): Sugar pill manufactured to mimic telmisartan 80 mg and amlodipine 5 mg tablet"
8773|NCT02734355|B1|Baseline|Therapy|"Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days~Telmisartan 80 mg and amlodipine 5 mg"
8774|NCT02734355|P2|Participant Flow|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
8775|NCT02734355|P1|Participant Flow|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
8776|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
8777|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
8778|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
8779|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
8780|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
8781|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
8782|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
8783|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
8784|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
8785|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
8786|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
8787|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
8788|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
8789|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
8790|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
8791|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
8792|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
8793|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
8794|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
8795|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
8796|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
8797|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
12497|NCT02647320|O1|Outcome|DS-8500a 25mg|One DS-8500a 25 mg tablets and placebo
8806|NCT02734212|B1|Baseline|Ending Self-Stigma for PTSD|Ending Self Stigma for PTSD (ESS-P) is a 9-session small-group (6-8 persons) course designed to help individuals with PTSD develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
8807|NCT02734212|P2|Participant Flow|Enhanced Treatment as Usual|The comparison condition will consist of providing a pamphlet that discusses societal stigma and internalized stigma, and provides resources to help combat the effects of both. Participants will be given the informational pamphlet and study staff will discuss its content with the participant.
8808|NCT02734212|P1|Participant Flow|Ending Self-Stigma for PTSD|Ending Self Stigma for PTSD (ESS-P) is a 9-session small-group (6-8 persons) course designed to help individuals with PTSD develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
8809|NCT02734212|O2|Outcome|Enhanced Treatment as Usual|The comparison condition will consist of providing a pamphlet that discusses societal stigma and internalized stigma, and provides resources to help combat the effects of both. Participants will be given the informational pamphlet and study staff will discuss its content with the participant.
8810|NCT02734212|O1|Outcome|Ending Self-Stigma for PTSD|Ending Self Stigma for PTSD (ESS-P) is a 9-session small-group (6-8 persons) course designed to help individuals with PTSD develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
8811|NCT02734212|O2|Outcome|Enhanced Treatment as Usual|The comparison condition will consist of providing a pamphlet that discusses societal stigma and internalized stigma, and provides resources to help combat the effects of both. Participants will be given the informational pamphlet and study staff will discuss its content with the participant.
8812|NCT02734212|O1|Outcome|Ending Self-Stigma for PTSD|Ending Self Stigma for PTSD (ESS-P) is a 9-session small-group (6-8 persons) course designed to help individuals with PTSD develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
8813|NCT02734212|O2|Outcome|Enhanced Treatment as Usual|The comparison condition will consist of providing a pamphlet that discusses societal stigma and internalized stigma, and provides resources to help combat the effects of both. Participants will be given the informational pamphlet and study staff will discuss its content with the participant.
8814|NCT02734212|O1|Outcome|Ending Self-Stigma for PTSD|Ending Self Stigma for PTSD (ESS-P) is a 9-session small-group (6-8 persons) course designed to help individuals with PTSD develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
8815|NCT02734212|E2|Reported Event|Enhanced Treatment as Usual|The comparison condition will consist of providing a pamphlet that discusses societal stigma and internalized stigma, and provides resources to help combat the effects of both. Participants will be given the informational pamphlet and study staff will discuss its content with the participant.
8816|NCT02734212|E1|Reported Event|Ending Self-Stigma for PTSD|Ending Self Stigma for PTSD (ESS-P) is a 9-session small-group (6-8 persons) course designed to help individuals with PTSD develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
8817|NCT02734056|B3|Baseline|Total|Total of all reporting groups
8818|NCT02734056|B2|Baseline|Control|"There is no intervention listed here because this is the control group, in which there will be no intervention.~Control: Control"
8819|NCT02734056|B1|Baseline|Music|"The intervention to be administered is music~Music: Listening to music that the patient likes"
8820|NCT02734056|P2|Participant Flow|Control|"There is no intervention listed here because this is the control group, in which there will be no intervention.~Control: Control"
8821|NCT02734056|P1|Participant Flow|Music|"The intervention to be administered is music~Music: Listening to music that the patient likes"
8822|NCT02734056|O2|Outcome|Control|"There is no intervention listed here because this is the control group, in which there will be no intervention.~Control: Control"
8823|NCT02734056|O1|Outcome|Music|"The intervention to be administered is music~Music: Listening to music that the patient likes"
8824|NCT02734056|E2|Reported Event|Control|"There is no intervention listed here because this is the control group, in which there will be no intervention.~Control: Control"
8825|NCT02734056|E1|Reported Event|Music|"The intervention to be administered is music~Music: Listening to music that the patient likes"
8826|NCT02732899|B3|Baseline|Total|Total of all reporting groups
8827|NCT02732899|B2|Baseline|Group 2|"Intravitreal injection of EYLEA® (aflibercept) will be given at baseline, week 8, 16, 24 and 32. Sham injections will be given at week 1, 4, 12, 20, and 28 in order to maintain masking of patient to treatment assignment~EYLEA"
8828|NCT02732899|B1|Baseline|Group 1|"Sirolimus 440ug for intravitreal injection will be provided in sterile single-use glass vials. One single-dose vial will be packaged in a box for each patient injection. Sirolimus injections will be given at baseline, week 4, 12, 20 and 28. EYLEA® (aflibercept) intravitreal injections will be given at week 1, 8, 16, 24 and 32.~Sirolimus~EYLEA"
9357|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
8830|NCT02732899|P1|Participant Flow|Group 1|"Sirolimus 440ug for intravitreal injection will be provided in sterile single-use glass vials. One single-dose vial will be packaged in a box for each patient injection. Sirolimus injections will be given at baseline, week 4, 12, 20 and 28. EYLEA® (aflibercept) intravitreal injections will be given at week 1, 8, 16, 24 and 32.~Sirolimus~EYLEA"
8831|NCT02732899|O2|Outcome|Group 2|"Intravitreal injection of EYLEA® (aflibercept) will be given at baseline, week 8, 16, 24 and 32. Sham injections will be given at week 1, 4, 12, 20, and 28 in order to maintain masking of patient to treatment assignment~EYLEA"
8832|NCT02732899|O1|Outcome|Group 1|"Sirolimus 440ug for intravitreal injection will be provided in sterile single-use glass vials. One single-dose vial will be packaged in a box for each patient injection. Sirolimus injections will be given at baseline, week 4, 12, 20 and 28. EYLEA® (aflibercept) intravitreal injections will be given at week 1, 8, 16, 24 and 32.~Sirolimus~EYLEA"
8833|NCT02732899|O2|Outcome|Group 2|"Intravitreal injection of EYLEA® (aflibercept) will be given at baseline, week 8, 16, 24 and 32. Sham injections will be given at week 1, 4, 12, 20, and 28 in order to maintain masking of patient to treatment assignment~EYLEA"
8834|NCT02732899|O1|Outcome|Group 1|"Sirolimus 440ug for intravitreal injection will be provided in sterile single-use glass vials. One single-dose vial will be packaged in a box for each patient injection. Sirolimus injections will be given at baseline, week 4, 12, 20 and 28. EYLEA® (aflibercept) intravitreal injections will be given at week 1, 8, 16, 24 and 32.~Sirolimus~EYLEA"
8835|NCT02732899|E2|Reported Event|Group 2|"Intravitreal injection of EYLEA® (aflibercept) will be given at baseline, week 8, 16, 24 and 32. Sham injections will be given at week 1, 4, 12, 20, and 28 in order to maintain masking of patient to treatment assignment~EYLEA"
8836|NCT02732899|E1|Reported Event|Group 1|"Sirolimus 440ug for intravitreal injection will be provided in sterile single-use glass vials. One single-dose vial will be packaged in a box for each patient injection. Sirolimus injections will be given at baseline, week 4, 12, 20 and 28. EYLEA® (aflibercept) intravitreal injections will be given at week 1, 8, 16, 24 and 32.~Sirolimus~EYLEA"
8837|NCT02732639|B1|Baseline|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
8838|NCT02732639|P1|Participant Flow|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
8839|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
8840|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
8841|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
8842|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
8843|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
8844|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
8845|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
8846|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
8847|NCT02732639|E1|Reported Event|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
8848|NCT02732561|B3|Baseline|Total|Total of all reporting groups
8849|NCT02732561|B2|Baseline|Intervention|"CES device. cranial electrotherapy stimulation device. Alpha Stim device~Alpha Stim device: cranial electrotherapy stimulation device"
8850|NCT02732561|B1|Baseline|Sham Device|"Sham device~Sham device: Sham device"
8851|NCT02732561|P2|Participant Flow|Intervention|"CES device. cranial electrotherapy stimulation device. Alpha Stim device~Alpha Stim device: cranial electrotherapy stimulation device"
8852|NCT02732561|P1|Participant Flow|Sham Device|"Sham device~Sham device: Sham device"
8853|NCT02732561|O2|Outcome|Intervention|"CES device. cranial electrotherapy stimulation device. Alpha Stim device~Alpha Stim device: cranial electrotherapy stimulation device"
8854|NCT02732561|O1|Outcome|Sham Device|"Sham device~Sham device: Sham device"
8855|NCT02732561|O2|Outcome|Intervention|"CES device. cranial electrotherapy stimulation device. Alpha Stim device~Alpha Stim device: cranial electrotherapy stimulation device"
8856|NCT02732561|O1|Outcome|Sham Device|"Sham device~Sham device: Sham device"
8857|NCT02732561|E2|Reported Event|Intervention|"CES device. cranial electrotherapy stimulation device. Alpha Stim device~Alpha Stim device: cranial electrotherapy stimulation device"
8858|NCT02732561|E1|Reported Event|Sham Device|"Sham device~Sham device: Sham device"
8859|NCT02732327|B3|Baseline|Total|Total of all reporting groups
8860|NCT02732327|B2|Baseline|Standard of Care+Vancomycin or Linezolid|Standard of Care (cefepime 2 g IV infusion every 8 hours or meropenem 1 g IV infusion every 8 hours or piperacillin/tazobactam 4.5 g IV infusion every 6 hours for 5 to 14 days, duration determined by the investigator) plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local SOC) may be allowed after at least 72 hours (ie, minimum of 9 doses for SOC therapies, except piperacillin/tazobactam, which is a minimum of 12 doses) of inpatient IV study drug.
8861|NCT02732327|B1|Baseline|CAZ-AVI + Vancomycin or Linezolid|Ceftazidime-Avibactam (CAZ-AVI) 2.5 mg intravenous (IV) infusion every 8 hours for 5 to 14 days, duration determined by the investigator, plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local standard of care [SOC]) may be allowed after at least 72 hours (ie, minimum of 9 doses for CAZ-AVI) of inpatient IV study drug.
8862|NCT02732327|P2|Participant Flow|Standard of Care+Vancomycin or Linezolid|Standard of Care (cefepime 2 g IV infusion every 8 hours or meropenem 1 g IV infusion every 8 hours or piperacillin/tazobactam 4.5 g IV infusion every 6 hours for 5 to 14 days, duration determined by the investigator) plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local SOC) may be allowed after at least 72 hours (ie, minimum of 9 doses for SOC therapies, except piperacillin/tazobactam, which is a minimum of 12 doses) of inpatient IV study drug.
8863|NCT02732327|P1|Participant Flow|CAZ-AVI + Vancomycin or Linezolid|Ceftazidime-Avibactam (CAZ-AVI) 2.5 mg intravenous (IV) infusion every 8 hours for 5 to 14 days, duration determined by the investigator, plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local standard of care [SOC]) may be allowed after at least 72 hours (ie, minimum of 9 doses for CAZ-AVI) of inpatient IV study drug.
8864|NCT02732327|O2|Outcome|Standard of Care+Vancomycin or Linezolid|Standard of Care (cefepime 2 g IV infusion every 8 hours or meropenem 1 g IV infusion every 8 hours or piperacillin/tazobactam 4.5 g IV infusion every 6 hours for 5 to 14 days, duration determined by the investigator) plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local SOC) may be allowed after at least 72 hours (ie, minimum of 9 doses for SOC therapies, except piperacillin/tazobactam, which is a minimum of 12 doses) of inpatient IV study drug.
8865|NCT02732327|O1|Outcome|CAZ-AVI + Vancomycin or Linezolid|Ceftazidime-Avibactam (CAZ-AVI) 2.5 mg intravenous (IV) infusion every 8 hours for 5 to 14 days, duration determined by the investigator, plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local standard of care [SOC]) may be allowed after at least 72 hours (ie, minimum of 9 doses for CAZ-AVI) of inpatient IV study drug.
8866|NCT02732327|E2|Reported Event|Standard of Care+Vancomycin or Linezolid|Standard of Care (cefepime 2 g IV infusion every 8 hours or meropenem 1 g IV infusion every 8 hours or piperacillin/tazobactam 4.5 g IV infusion every 6 hours for 5 to 14 days, duration determined by the investigator) plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local SOC) may be allowed after at least 72 hours (ie, minimum of 9 doses for SOC therapies, except piperacillin/tazobactam, which is a minimum of 12 doses) of inpatient IV study drug.
8867|NCT02732327|E1|Reported Event|CAZ-AVI + Vancomycin or Linezolid|Ceftazidime-Avibactam (CAZ-AVI) 2.5 mg intravenous (IV) infusion every 8 hours for 5 to 14 days, duration determined by the investigator, plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local standard of care [SOC]) may be allowed after at least 72 hours (ie, minimum of 9 doses for CAZ-AVI) of inpatient IV study drug.
8868|NCT02732210|B3|Baseline|Total|Total of all reporting groups
8869|NCT02732210|B2|Baseline|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
8870|NCT02732210|B1|Baseline|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
8871|NCT02732210|P2|Participant Flow|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
8872|NCT02732210|P1|Participant Flow|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
8873|NCT02732210|O2|Outcome|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
8874|NCT02732210|O1|Outcome|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
8875|NCT02732210|O2|Outcome|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
8876|NCT02732210|O1|Outcome|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
8877|NCT02732210|O2|Outcome|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
9358|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
8878|NCT02732210|O1|Outcome|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
8879|NCT02732210|O2|Outcome|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
8880|NCT02732210|O1|Outcome|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
8881|NCT02732210|O2|Outcome|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
8882|NCT02732210|O1|Outcome|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
8883|NCT02732210|O2|Outcome|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
8884|NCT02732210|O1|Outcome|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
8885|NCT02732210|E2|Reported Event|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
8886|NCT02732210|E1|Reported Event|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
8887|NCT02731833|B3|Baseline|Total|Total of all reporting groups
8888|NCT02731833|B2|Baseline|Sodium Monofluorophosphate|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
8889|NCT02731833|B1|Baseline|Stannous Fluoride|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
8890|NCT02731833|P2|Participant Flow|Sodium Monofluorophosphate|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
8891|NCT02731833|P1|Participant Flow|Stannous Fluoride|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
8892|NCT02731833|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
8893|NCT02731833|O1|Outcome|Stannous Fluoride|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
8894|NCT02731833|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
8895|NCT02731833|O1|Outcome|Stannous Fluoride|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
8896|NCT02731833|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
8897|NCT02731833|O1|Outcome|Stannous Fluoride|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
8898|NCT02731833|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
8899|NCT02731833|O1|Outcome|Stannous Fluoride|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
8900|NCT02731833|E2|Reported Event|Sodium Monofluorophosphate|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
13384|NCT02637999|O3|Outcome|PEG IFN|PEG IFN alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
8901|NCT02731833|E1|Reported Event|Stannous Fluoride|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
8902|NCT02731313|B1|Baseline|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma Samples|"Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned~Trastuzumab: Trastuzumab was not administered in this study. This study informs future trastuzumab treatment decisions."
8903|NCT02731313|P1|Participant Flow|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
8904|NCT02731313|O1|Outcome|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
8905|NCT02731313|O1|Outcome|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
8906|NCT02731313|O1|Outcome|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
8907|NCT02731313|O1|Outcome|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
8908|NCT02731313|O1|Outcome|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
8909|NCT02731313|E1|Reported Event|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
8910|NCT02731300|B3|Baseline|Total|Total of all reporting groups
8911|NCT02731300|B2|Baseline|Sham tDCS|"0 mA of sham tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
8912|NCT02731300|B1|Baseline|Active tDCS|"2 mA of cathodal tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
8913|NCT02731300|P2|Participant Flow|Sham tDCS|"0 mA of sham tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
8914|NCT02731300|P1|Participant Flow|Active tDCS|"2 milliampere (mA) of cathodal tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
8915|NCT02731300|O2|Outcome|Sham tDCS|"0 mA of sham tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
8916|NCT02731300|O1|Outcome|Active tDCS|"2 mA of cathodal tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
8917|NCT02731300|O2|Outcome|Sham tDCS|"0 mA of sham tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
8918|NCT02731300|O1|Outcome|Active tDCS|"2 mA of cathodal tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
8919|NCT02731300|E2|Reported Event|Sham tDCS|"0 mA of sham tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
8920|NCT02731300|E1|Reported Event|Active tDCS|"2 mA of cathodal tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
8921|NCT02731131|B3|Baseline|Total|Total of all reporting groups
8922|NCT02731131|B2|Baseline|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
8923|NCT02731131|B1|Baseline|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
8924|NCT02731131|P2|Participant Flow|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 milligrams (mg) per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
8925|NCT02731131|P1|Participant Flow|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection.
8926|NCT02731131|O2|Outcome|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
8927|NCT02731131|O1|Outcome|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
8928|NCT02731131|O2|Outcome|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
8929|NCT02731131|O1|Outcome|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
8930|NCT02731131|O2|Outcome|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
8931|NCT02731131|O1|Outcome|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
8932|NCT02731131|O2|Outcome|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
8933|NCT02731131|O1|Outcome|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
8934|NCT02731131|O2|Outcome|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
8935|NCT02731131|O1|Outcome|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
8936|NCT02731131|O2|Outcome|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
8937|NCT02731131|O1|Outcome|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
8938|NCT02731131|E2|Reported Event|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
8939|NCT02731131|E1|Reported Event|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
8940|NCT02730819|B1|Baseline|Illuminate Cream|Illuminate Cream is a skin-lightening formulation containing multiple drugs, including a retinoid, calcineurin inhibitor, anti-tyrosinase agent and sunscreen microfine zinc oxide. Approximately 0.5 grams to be applied topically to affected areas of skin once per day for 20 weeks.
8941|NCT02730819|P1|Participant Flow|Illuminate Cream|Illuminate Cream is a skin-lightening formulation containing multiple drugs, including a retinoid, calcineurin inhibitor, anti-tyrosinase agent and sunscreen microfine zinc oxide. Approximately 0.5 grams to be applied topically to affected areas of skin once per day for 20 weeks.
8942|NCT02730819|O1|Outcome|Illuminate Cream|Illuminate Cream is a skin-lightening formulation containing multiple drugs, including a retinoid, calcineurin inhibitor, anti-tyrosinase agent and sunscreen microfine zinc oxide. Approximately 0.5 grams to be applied topically to affected areas of skin once per day for 20 weeks.
8943|NCT02730819|O1|Outcome|Illuminate Cream|Illuminate Cream is a skin-lightening formulation containing multiple drugs, including a retinoid, calcineurin inhibitor, anti-tyrosinase agent and sunscreen microfine zinc oxide. Approximately 0.5 grams to be applied topically to affected areas of skin once per day for 20 weeks.
8944|NCT02730819|O1|Outcome|Illuminate Cream|Illuminate Cream is a skin-lightening formulation containing multiple drugs, including a retinoid, calcineurin inhibitor, anti-tyrosinase agent and sunscreen microfine zinc oxide. Approximately 0.5 grams to be applied topically to affected areas of skin once per day for 20 weeks.
8945|NCT02730819|E1|Reported Event|Illuminate Cream|Illuminate Cream is a skin-lightening formulation containing multiple drugs, including a retinoid, calcineurin inhibitor, anti-tyrosinase agent and sunscreen microfine zinc oxide. Approximately 0.5 grams to be applied topically to affected areas of skin once per day for 20 weeks.
8946|NCT02730351|B1|Baseline|All Treatment Combined|After screening, the eligible participants entered a 4-week single blind run-in period on FP 250 µg BID following which the participants were randomized to one of the following two treatment sequences in a ratio of 1:1: FF/VI 100/25 µg QD via ELLIPTA + Placebo BID via DISKUS in treatment period 1 followed by FP 250 µg BID via DISKUS + Placebo QD via ELLIPTA in treatment period 2 or FP 250 µg BID via DISKUS + Placebo QD via ELLIPTA in treatment period 1 followed by FF/VI 100/25 µg once daily (QD) via ELLIPTA + Placebo BID via DISKUS in treatment period 2. All participants entered a 2-week single blind wash-out period on FP 250 µg BID between the two treatment periods. The participants were followed up for approximately 7 days after completing Treatment Period 2. Albuterol/salbutamol was issued for rescue use during the run-in, wash-out and treatment periods as needed.
8947|NCT02730351|P2|Participant Flow|FP 250 µg Followed by FF/VI 100/25 µg|After screening, the eligible participants entered a 4-week single blind run-in period on FP 250 µg BID following which the participants were randomized to receive FP 250 µg BID via DISKUS + Placebo QD via ELLIPTA in treatment period 1 followed by a 2-week single blind wash-out period on FP 250 µg BID. The participants then received FF/VI 100/25 µg QD via ELLIPTA + Placebo BID via DISKUS in treatment period 2. The participants were followed up for approximately 7 days after completing Treatment Period 2. Albuterol/salbutamol was issued for rescue use during the run-in, wash-out and treatment periods as needed.
8948|NCT02730351|P1|Participant Flow|FF/VI 100/25 µg Followed by FP 250 µg|After screening, the eligible participants entered a 4-week single blind run-in period on FP 250 microgram (µg) twice daily (BID) following which the participants were randomized to receive FF/VI 100/25 µg once daily (QD) via ELLIPTA + Placebo BID via DISKUS in treatment period 1 followed by a 2-week single blind wash-out period on FP 250 µg BID. The participants then received FP 250 µg BID via DISKUS + Placebo QD via ELLIPTA in treatment period 2. The participants were followed up for approximately 7 days after completing Treatment Period 2. Albuterol/salbutamol was issued for rescue use during the run-in, wash-out and treatment periods as needed.
8949|NCT02730351|O2|Outcome|FP 250 µg BID Via DISKUS + Placebo QD Via ELLIPTA|Participants were administered FP 250 µg BID via DISKUS + Placebo QD via ELLIPTA in one of the two treatment periods. Each treatment period was of 2 weeks with a single blind 2 week wash-out period on FP 250 µg BID between the treatment periods. Albuterol/salbutamol was issued for rescue use during the run-in, wash-out and treatment periods as needed.
8983|NCT02727816|O1|Outcome|Filcon IV I (BC 8.7) - Pair Four|"Participants were randomized to a test and control lens for each pair in a contralateral design.~filcon IV I (BC 8.7): control lens"
9359|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
8950|NCT02730351|O1|Outcome|FF/VI 100/25 µg QD Via ELLIPTA + Placebo BID Via DISKUS|Participants were administered FF/VI 100/25 µg QD via ELLIPTA + Placebo BID via DISKUS in one of the two treatment periods. Each treatment period was of 2 weeks with a single blind 2 week wash-out period on FP 250 µg BID between the treatment periods. Albuterol/salbutamol was issued for rescue use during the run-in, wash-out and treatment periods as needed.
8951|NCT02730351|O2|Outcome|FP 250 µg BID Via DISKUS + Placebo QD Via ELLIPTA|Participants were administered FP 250 µg BID via DISKUS + Placebo QD via ELLIPTA in one of the two treatment periods. Each treatment period was of 2 weeks with a single blind 2 week wash-out period on FP 250 µg BID between the treatment periods. Albuterol/salbutamol was issued for rescue use during the run-in, wash-out and treatment periods as needed.
8952|NCT02730351|O1|Outcome|FF/VI 100/25 µg QD Via ELLIPTA + Placebo BID Via DISKUS|Participants were administered FF/VI 100/25 µg QD via ELLIPTA + Placebo BID via DISKUS in one of the two treatment periods. Each treatment period was of 2 weeks with a single blind 2 week wash-out period on FP 250 µg BID between the treatment periods. Albuterol/salbutamol was issued for rescue use during the run-in, wash-out and treatment periods as needed.
8953|NCT02730351|O2|Outcome|FP 250 µg BID Via DISKUS + Placebo QD Via ELLIPTA|Participants were administered FP 250 µg BID via DISKUS + Placebo QD via ELLIPTA in one of the two treatment periods. Each treatment period was of 2 weeks with a single blind 2 week wash-out period on FP 250 µg BID between the treatment periods. Albuterol/salbutamol was issued for rescue use during the run-in, wash-out and treatment periods as needed.
8954|NCT02730351|O1|Outcome|FF/VI 100/25 µg QD Via ELLIPTA + Placebo BID Via DISKUS|Participants were administered FF/VI 100/25 µg QD via ELLIPTA + Placebo BID via DISKUS in one of the two treatment periods. Each treatment period was of 2 weeks with a single blind 2 week wash-out period on FP 250 µg BID between the treatment periods. Albuterol/salbutamol was issued for rescue use during the run-in, wash-out and treatment periods as needed.
8955|NCT02730351|O2|Outcome|FP 250 µg BID Via DISKUS + Placebo QD Via ELLIPTA|Participants were administered FP 250 µg BID via DISKUS + Placebo QD via ELLIPTA in one of the two treatment periods. Each treatment period was of 2 weeks with a single blind 2 week wash-out period on FP 250 µg BID between the treatment periods. Albuterol/salbutamol was issued for rescue use during the run-in, wash-out and treatment periods as needed.
8956|NCT02730351|O1|Outcome|FF/VI 100/25 µg QD Via ELLIPTA + Placebo BID Via DISKUS|Participants were administered FF/VI 100/25 µg QD via ELLIPTA + Placebo BID via DISKUS in one of the two treatment periods. Each treatment period was of 2 weeks with a single blind 2 week wash-out period on FP 250 µg BID between the treatment periods. Albuterol/salbutamol was issued for rescue use during the run-in, wash-out and treatment periods as needed.
8957|NCT02730351|E2|Reported Event|FP 250 µg BID Via DISKUS + Placebo QD Via ELLIPTA|FP 250 µg BID via DISKUS + Placebo QD via ELLIPTA
8958|NCT02730351|E1|Reported Event|FF/VI 100/25 µg QD Via ELLIPTA + Placebo BID Via DISKUS|FF/VI 100/25 µg QD via ELLIPTA + Placebo BID via DISKUS
8959|NCT02730260|B3|Baseline|Total|Total of all reporting groups
8960|NCT02730260|B2|Baseline|Nondirective|"Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.~Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call."
8961|NCT02730260|B1|Baseline|Directive|"Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.~Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda."
8962|NCT02730260|P2|Participant Flow|Nondirective|"Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.~Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call."
8963|NCT02730260|P1|Participant Flow|Directive|"Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.~Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda."
8964|NCT02730260|O2|Outcome|Nondirective|"Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.~Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call."
8965|NCT02730260|O1|Outcome|Directive|"Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.~Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda."
8966|NCT02730260|E2|Reported Event|Nondirective|"Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.~Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call."
8967|NCT02730260|E1|Reported Event|Directive|"Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.~Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda."
8968|NCT02727816|B1|Baseline|Overall Participants|Participants were randomized to a test and control lens for each of the four lens pair in a contralateral design.
8969|NCT02727816|P1|Participant Flow|Overall Participants|Participants were randomized to a test and control lens for each of the four lens pair in a contralateral design.
8970|NCT02727816|O3|Outcome|No Preference|
8971|NCT02727816|O2|Outcome|Prefer Somofilcon A - Pair Four|
8972|NCT02727816|O1|Outcome|Prefer Methafilcon A (BC 8.7) - Pair Four|
8973|NCT02727816|O3|Outcome|No Preference|
8974|NCT02727816|O2|Outcome|Prefer Ocufilcon D - Pair Three|
8975|NCT02727816|O1|Outcome|Prefer Methafilcon A (BC 8.6) - Pair Three|
8976|NCT02727816|O3|Outcome|No Preference|
8977|NCT02727816|O2|Outcome|Prefer Ocufilcon D - Pair Two|
8978|NCT02727816|O1|Outcome|Prefer Filcon IV I (BC 8.7) - Pair Two|
8979|NCT02727816|O3|Outcome|No Preference|
8980|NCT02727816|O2|Outcome|Prefer Ocufilcon D - Pair One|
8981|NCT02727816|O1|Outcome|Prefer Filcon IV I (BC 8.6) - Pair One|
8982|NCT02727816|O2|Outcome|Somofilcon A - Pair Four|"Participants were randomized to a test and control lens for each pair in a contralateral design.~somofilcon A: test lens"
20047|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
8984|NCT02727816|O2|Outcome|Ocufilcon D - Pair Three|"Participants were randomized to a test and control lens for each pair in a contralateral design.~ocufilcon D: test lens"
8985|NCT02727816|O1|Outcome|Filcon IV I (BC 8.6) - Pair Three|"Participants were randomized to a test and control lens for each pair in a contralateral design.~filcon IV I (BC 8.7): control lens"
8986|NCT02727816|O2|Outcome|Ocufilcon D - Pair Two|"Participants were randomized to a test and control lens for each pair in a contralateral design.~ocufilcon D: test lens"
8987|NCT02727816|O1|Outcome|Filcon IV I (BC 8.7) - Pair Two|"Participants were randomized to a test and control lens for each pair in a contralateral design.~filcon IV I (BC 8.7): control lens"
8988|NCT02727816|O2|Outcome|Ocufilcon D - Pair One|"Participants were randomized to a test and control lens for each pair in a contralateral design.~ocufilcon D: test lens"
8989|NCT02727816|O1|Outcome|Filcon IV I (BC 8.6) - Pair One|"Participants were randomized to a test and control lens for each pair in a contralateral design.~filcon IV I (BC 8.6): control lens"
8990|NCT02727816|O2|Outcome|Somofilcon A - Pair Four|"Participants were randomized to a test and control lens for each pair in a contralateral design.~somofilcon A: test lens"
8991|NCT02727816|O1|Outcome|Filcon IV I (BC 8.7) - Pair Four|"Participants were randomized to a test and control lens for each pair in a contralateral design.~filcon IV I (BC 8.7): control lens"
8992|NCT02727816|O2|Outcome|Somofilcon A - Pair Four|"Participants were randomized to a test and control lens for each pair in a contralateral design.~somofilcon A: test lens"
8993|NCT02727816|O1|Outcome|Filcon IV I (BC 8.7) - Pair Four|"Participants were randomized to a test and control lens for each pair in a contralateral design.~filcon IV I (BC 8.7): control lens"
8994|NCT02727816|O2|Outcome|Ocufilcon D - Pair Three|"Participants were randomized to a test and control lens for each pair in a contralateral design.~ocufilcon D: test lens"
8995|NCT02727816|O1|Outcome|Filcon IV I (BC 8.6) - Pair Three|"Participants were randomized to a test and control lens for each pair in a contralateral design.~filcon IV I (BC 8.7): control lens"
8996|NCT02727816|O2|Outcome|Ocufilcon D - Pair Three|"Participants were randomized to a test and control lens for each pair in a contralateral design.~ocufilcon D: test lens"
8997|NCT02727816|O1|Outcome|Filcon IV I (BC 8.6) - Pair Three|"Participants were randomized to a test and control lens for each pair in a contralateral design.~filcon IV I (BC 8.7): control lens"
8998|NCT02727816|O2|Outcome|Ocufilcon D - Pair Two|"Participants were randomized to a test and control lens for each pair in a contralateral design.~ocufilcon D: test lens"
8999|NCT02727816|O1|Outcome|Filcon IV I (BC 8.7) - Pair Two|"Participants were randomized to a test and control lens for each pair in a contralateral design.~filcon IV I (BC 8.7): control lens"
9000|NCT02727816|O2|Outcome|Ocufilcon D - Pair Two|"Participants were randomized to a test and control lens for each pair in a contralateral design.~ocufilcon D: test lens"
9001|NCT02727816|O1|Outcome|Filcon IV I (BC 8.7) - Pair Two|"Participants were randomized to a test and control lens for each pair in a contralateral design.~filcon IV I (BC 8.7): control lens"
9002|NCT02727816|O2|Outcome|Ocufilcon D - Pair One|"Participants were randomized to a test and control lens for each pair in a contralateral design.~ocufilcon D: test lens"
9003|NCT02727816|O1|Outcome|Filcon IV I (BC 8.6) - Pair One|"Participants were randomized to a test and control lens for each pair in a contralateral design.~filcon IV I (BC 8.6): control lens"
9004|NCT02727816|O2|Outcome|Ocufilcon D - Pair One|"Participants were randomized to a test and control lens for each pair in a contralateral design.~ocufilcon D: test lens"
9005|NCT02727816|O1|Outcome|Filcon IV I (BC 8.6) - Pair One|"Participants were randomized to a test and control lens for each pair in a contralateral design.~filcon IV I (BC 8.6): control lens"
9006|NCT02727816|O2|Outcome|Somofilcon A - Pair Four|"Participants were randomized to a test and control lens for each pair in a contralateral design.~somofilcon A: test lens"
9007|NCT02727816|O1|Outcome|Filcon IV I (BC 8.7) - Pair Four|"Participants were randomized to a test and control lens for each pair in a contralateral design.~filcon IV I (BC 8.7): control lens"
9008|NCT02727816|O2|Outcome|Ocufilcon D - Pair Three|"Participants were randomized to a test and control lens for each pair in a contralateral design.~ocufilcon D: test lens"
9009|NCT02727816|O1|Outcome|Filcon IV I (BC 8.6) - Pair Three|"Participants were randomized to a test and control lens for each pair in a contralateral design.~filcon IV I (BC 8.7): control lens"
9010|NCT02727816|O2|Outcome|Ocufilcon D - Pair Two|"Participants were randomized to a test and control lens for each pair in a contralateral design.~ocufilcon D: test lens"
9011|NCT02727816|O1|Outcome|Filcon IV I (BC 8.7) - Pair Two|"Participants were randomized to a test and control lens for each pair in a contralateral design.~filcon IV I (BC 8.7): control lens"
9012|NCT02727816|O2|Outcome|Ocufilcon D - Pair One|"Participants were randomized to a test and control lens for each pair in a contralateral design.~ocufilcon D: test lens"
9013|NCT02727816|O1|Outcome|Filcon IV I (BC 8.6) - Pair One|"Participants were randomized to a test and control lens for each pair in a contralateral design.~filcon IV I (BC 8.6): control lens"
9014|NCT02727816|E1|Reported Event|Overall Participants|Participants were randomized to a test and control lens for each of the four lens pair in a contralateral design.
9015|NCT02726971|B3|Baseline|Total|Total of all reporting groups
9016|NCT02726971|B2|Baseline|6mg Estradiol Therapy(High Dose)|"mean Age(y):32.3 Gender:Female BMI:21.0 mean Number of miscarriage: 2.1~BMI=body mass index"
9017|NCT02726971|B1|Baseline|2mg Estradiol Therapy(Low Dose)|"mean Age(y):31.9 Gender:Female BMI:21.2 mean Number of miscarriage: 2.3~BMI=body mass index"
9018|NCT02726971|P2|Participant Flow|6mg Estradiol Therapy(High Dose)|"6mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.~Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
9019|NCT02726971|P1|Participant Flow|2mg Estradiol Therapy(Low Dose)|"2mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.~Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
9020|NCT02726971|O2|Outcome|6mg Estradiol Therapy(High Dose)|"6mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.~Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
9021|NCT02726971|O1|Outcome|2mg Estradiol Therapy(Low Dose)|"2mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.~Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
9022|NCT02726971|O2|Outcome|6mg Estradiol Therapy(High Dose)|"6mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.~Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
9023|NCT02726971|O1|Outcome|2mg Estradiol Therapy(Low Dose)|"2mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.~Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
9024|NCT02726971|O2|Outcome|6mg Estradiol Therapy(High Dose)|"6mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.~Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
9025|NCT02726971|O1|Outcome|2mg Estradiol Therapy(Low Dose)|"2mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.~Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
9026|NCT02726971|E2|Reported Event|6mg Estradiol Therapy(High Dose)|"6mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.~Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
9027|NCT02726971|E1|Reported Event|2mg Estradiol Therapy(Low Dose)|"2mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.~Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
9028|NCT02726178|B3|Baseline|Total|Total of all reporting groups
9029|NCT02726178|B2|Baseline|Control|"Oral placebo: composed of sodium stearate 0.25g + lactose 0.5g + 15 ml of simple syrup, with a measured osmolarity of about 750 mosml/kg.~The drug (or placebo) was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.~Placebo: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
9030|NCT02726178|B1|Baseline|Advil® Pediatric Drops for Infants|"Oral ibuprofen (Advil® Pediatric drops for infants less than 3 months of age; Wyeth-Ayerst 40 mg/ml, DIN 2242522), at a dosage of 5 mg/kg/dose.~The drug was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.~Advil® Pediatric drops for infants: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
9031|NCT02726178|P2|Participant Flow|Control|"Oral placebo: composed of sodium stearate 0.25g + lactose 0.5g + 15 ml of simple syrup, with a measured osmolarity of about 750 mosml/kg.~The drug (or placebo) was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.~Placebo: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
9032|NCT02726178|P1|Participant Flow|Advil® Pediatric Drops for Infants|"Oral ibuprofen (Advil® Pediatric drops for infants less than 3 months of age; Wyeth-Ayerst 40 mg/ml, DIN 2242522), at a dosage of 5 mg/kg/dose.~The drug was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.~Advil® Pediatric drops for infants: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
9033|NCT02726178|O2|Outcome|Control|"Two annotated polysomnographies were performed for all patients:~The first annotated polysomnography was conducted the day before immunization and had a duration of 2.5 hours.~The second was conducted 18 to 24 hours after immunization.~We compared the data of polysomnographies after to those before immunization.~Polysomnography : an AURA PSG GRASS ambulatory and wireless system."
9034|NCT02726178|O1|Outcome|Advil® Pediatric Drops for Infants|"Two annotated polysomnographies were performed for all patients:~The first annotated polysomnography was conducted the day before immunization and had a duration of 2.5 hours.~The second was conducted 18 to 24 hours after immunization.~We compared the data of polysomnographies after to those before immunization.~Polysomnography : an AURA PSG GRASS ambulatory and wireless system."
9035|NCT02726178|O2|Outcome|Control|"Oral placebo: composed of sodium stearate 0.25g + lactose 0.5g + 15 ml of simple syrup, with a measured osmolarity of about 750 mosml/kg.~The drug (or placebo) was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.~Placebo: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
9036|NCT02726178|O1|Outcome|Advil® Pediatric Drops for Infants|"Oral ibuprofen (Advil® Pediatric drops for infants less than 3 months of age; Wyeth-Ayerst 40 mg/ml, DIN 2242522), at a dosage of 5 mg/kg/dose.~The drug was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.~Advil® Pediatric drops for infants: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
9037|NCT02726178|E2|Reported Event|Control|"Oral placebo: composed of sodium stearate 0.25g + lactose 0.5g + 15 ml of simple syrup, with a measured osmolarity of about 750 mosml/kg.~The drug (or placebo) was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.~Placebo: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
9038|NCT02726178|E1|Reported Event|Advil® Pediatric Drops for Infants|"Oral ibuprofen (Advil® Pediatric drops for infants less than 3 months of age; Wyeth-Ayerst 40 mg/ml, DIN 2242522), at a dosage of 5 mg/kg/dose.~The drug was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.~Advil® Pediatric drops for infants: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
9039|NCT02726022|B1|Baseline|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
9040|NCT02726022|P1|Participant Flow|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a (Pegasys) and ribavirin (Copegus) for four weeks, were observed up to 24 weeks after end of treatment (EOT) (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
9041|NCT02726022|O1|Outcome|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
9042|NCT02726022|O1|Outcome|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
9043|NCT02726022|O1|Outcome|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
9044|NCT02726022|O1|Outcome|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
9045|NCT02726022|O1|Outcome|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
9046|NCT02726022|O1|Outcome|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
9047|NCT02726022|E1|Reported Event|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
9048|NCT02725788|B3|Baseline|Total|Total of all reporting groups
9049|NCT02725788|B2|Baseline|Standard PIV Dressing|Film adhesive dressing used with medical grade tape and sized to cover, secure peripheral (PIV) catheters
9050|NCT02725788|B1|Baseline|New Dressing|Bordered, notched film dressing sized to cover, secure peripheral venous (PIV) catheters
9051|NCT02725788|P2|Participant Flow|Standard PIV Dressing|Film adhesive dressing used with medical grade tape and sized to cover, secure peripheral (PIV) catheters
9052|NCT02725788|P1|Participant Flow|New Dressing|Bordered, notched film dressing sized to cover, secure peripheral venous (PIV) catheters
9053|NCT02725788|O2|Outcome|Standard PIV Dressing|Film adhesive dressing used with medical grade tape and sized to cover, secure peripheral (PIV) catheters
9054|NCT02725788|O1|Outcome|New Dressing|Bordered, notched film dressing sized to cover, secure peripheral venous (PIV) catheters
9055|NCT02725788|E2|Reported Event|Standard PIV Dressing|Film adhesive dressing used with medical grade tape and sized to cover, secure peripheral (PIV) catheters
9056|NCT02725788|E1|Reported Event|New Dressing|Bordered, notched film dressing sized to cover, secure peripheral venous (PIV) catheters
9057|NCT02724644|B3|Baseline|Total|Total of all reporting groups
9058|NCT02724644|B2|Baseline|Placebo|Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
9059|NCT02724644|B1|Baseline|EN3835 0.84 mg|"Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.~Injectable intervention"
9060|NCT02724644|P2|Participant Flow|Placebo|Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
9061|NCT02724644|P1|Participant Flow|EN3835 0.84 mg|"Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.~Injectable intervention"
9062|NCT02724644|O2|Outcome|Placebo|Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
9063|NCT02724644|O1|Outcome|EN3835 0.84 mg|"Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.~Injectable intervention"
9064|NCT02724644|O2|Outcome|Placebo|Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
9065|NCT02724644|O1|Outcome|EN3835 0.84 mg|"Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.~Injectable intervention"
9066|NCT02724644|O2|Outcome|Placebo|Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
9067|NCT02724644|O1|Outcome|EN3835 0.84 mg|"Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.~Injectable intervention"
9068|NCT02724644|O2|Outcome|Placebo|Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
9069|NCT02724644|O1|Outcome|EN3835 0.84 mg|"Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.~Injectable intervention"
9070|NCT02724644|O2|Outcome|Placebo|Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
9071|NCT02724644|O1|Outcome|EN3835 0.84 mg|"Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.~Injectable intervention"
9072|NCT02724644|O2|Outcome|Placebo|Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
9073|NCT02724644|O1|Outcome|EN3835 0.84 mg|"Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.~Injectable intervention"
9075|NCT02724644|O1|Outcome|EN3835 0.84 mg|"Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.~Injectable intervention"
9076|NCT02724644|O2|Outcome|Placebo|Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
9077|NCT02724644|O1|Outcome|EN3835 0.84 mg|"Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.~Injectable intervention"
9078|NCT02724644|O2|Outcome|Placebo|Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
9079|NCT02724644|O1|Outcome|EN3835 0.84 mg|"Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.~Injectable intervention"
9080|NCT02724644|O2|Outcome|Placebo|Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
9081|NCT02724644|O1|Outcome|EN3835 0.84 mg|"Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.~Injectable intervention"
9082|NCT02724644|O2|Outcome|Placebo|Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
9083|NCT02724644|O1|Outcome|EN3835 0.84 mg|"Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.~Injectable intervention"
9084|NCT02724644|O2|Outcome|Placebo|Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
9085|NCT02724644|O1|Outcome|EN3835 0.84 mg|"Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.~Injectable intervention"
9086|NCT02724644|E2|Reported Event|Placebo|Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
9087|NCT02724644|E1|Reported Event|EN3835 0.84 mg|"Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.~Injectable intervention"
9088|NCT02724449|B1|Baseline|Cavilon Advanced Barrier Film|"Cavilon Advanced Barrier Film applied to areas of IAD~Cavilon Advanced Barrier Film: Cavilon Advanced Barrier Fim's application applied twice a week"
9089|NCT02724449|P1|Participant Flow|Open-label Study|No competitive products evaluated.
9090|NCT02724449|O1|Outcome|Open Label Study|
9091|NCT02724449|E1|Reported Event|Open-label Study|Single arm study
9092|NCT02724111|B3|Baseline|Total|Total of all reporting groups
9093|NCT02724111|B2|Baseline|Restricted Neuromuscular Blockade|"This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade [NMB] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change [a prone position]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.~sugammadex 10 min after position change"
9094|NCT02724111|B1|Baseline|Deep Neuromuscular Blockade|"This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade [NMB] (TOF count 0, post-tetanic count [PTC] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.~sufficient dose of rocuronium"
9095|NCT02724111|P2|Participant Flow|Restricted Neuromuscular Blockade|"This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade [NMB] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change [a prone position]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.~sugammadex 10 min after position change"
9096|NCT02724111|P1|Participant Flow|Deep Neuromuscular Blockade|"This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade [NMB] (train-of-four [TOF] count 0, post-tetanic count [PTC] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.~sufficient dose of rocuronium"
9097|NCT02724111|O2|Outcome|Restricted Neuromuscular Blockade|"This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade [NMB] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change [a prone position]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.~sugammadex 10 min after position change"
9098|NCT02724111|O1|Outcome|Deep Neuromuscular Blockade|"This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade [NMB] (TOF count 0, post-tetanic count [PTC] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.~sufficient dose of rocuronium"
9099|NCT02724111|O2|Outcome|Restricted Neuromuscular Blockade|"This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade [NMB] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change [a prone position]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.~sugammadex 10 min after position change"
9100|NCT02724111|O1|Outcome|Deep Neuromuscular Blockade|"This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade [NMB] (TOF count 0, post-tetanic count [PTC] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.~sufficient dose of rocuronium"
9101|NCT02724111|O2|Outcome|Restricted Neuromuscular Blockade|"This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade [NMB] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change [a prone position]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.~sugammadex 10 min after position change"
9102|NCT02724111|O1|Outcome|Deep Neuromuscular Blockade|"This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade [NMB] (TOF count 0, post-tetanic count [PTC] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.~sufficient dose of rocuronium"
9103|NCT02724111|O2|Outcome|Restricted Neuromuscular Blockade|"This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade [NMB] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change [a prone position]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.~sugammadex 10 min after position change"
9104|NCT02724111|O1|Outcome|Deep Neuromuscular Blockade|"This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade [NMB] (TOF count 0, post-tetanic count [PTC] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.~sufficient dose of rocuronium"
9105|NCT02724111|O2|Outcome|Restricted Neuromuscular Blockade|"This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade [NMB] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change [a prone position]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.~sugammadex 10 min after position change"
9106|NCT02724111|O1|Outcome|Deep Neuromuscular Blockade|"This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade [NMB] (TOF count 0, post-tetanic count [PTC] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.~sufficient dose of rocuronium"
9107|NCT02724111|O2|Outcome|Restricted Neuromuscular Blockade|"This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade [NMB] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change [a prone position]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.~sugammadex 10 min after position change"
9108|NCT02724111|O1|Outcome|Deep Neuromuscular Blockade|"This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade [NMB] (TOF count 0, post-tetanic count [PTC] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.~sufficient dose of rocuronium"
9109|NCT02724111|O2|Outcome|Restricted Neuromuscular Blockade|"This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade [NMB] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change [a prone position]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.~sugammadex 10 min after position change"
9110|NCT02724111|O1|Outcome|Deep Neuromuscular Blockade|"This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade [NMB] (TOF count 0, post-tetanic count [PTC] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.~sufficient dose of rocuronium"
9111|NCT02724111|O2|Outcome|Restricted Neuromuscular Blockade|"This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade [NMB] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change [a prone position]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.~sugammadex 10 min after position change"
16535|NCT02597049|E3|Reported Event|Placebo|Placebo given SC QW for 24 weeks.
9112|NCT02724111|O1|Outcome|Deep Neuromuscular Blockade|"This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade [NMB] (TOF count 0, post-tetanic count [PTC] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.~sufficient dose of rocuronium"
9113|NCT02724111|E2|Reported Event|Restricted Neuromuscular Blockade|"This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade [NMB] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change [a prone position]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.~sugammadex 10 min after position change"
9114|NCT02724111|E1|Reported Event|Deep Neuromuscular Blockade|"This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade [NMB] (TOF count 0, post-tetanic count [PTC] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.~sufficient dose of rocuronium"
9115|NCT02723201|B4|Baseline|Total|Total of all reporting groups
9116|NCT02723201|B3|Baseline|Part 2- TAK-020 25 mg CCT: Fed + Fasted|TAK-020 25 mg, CCT, orally, under fed state, once on Day 1 of first intervention period, followed by 7 days of washout period, further followed by TAK-020 25 mg, CCT, orally, under fasted state, once on Day 1 of second intervention period.
9117|NCT02723201|B2|Baseline|Part 2- TAK-020 25 mg CCT: Fasted + Fed|TAK-020 25 mg, CCT, orally, under fasted state, once on Day 1 of first intervention period, followed by 7 days of washout period, further followed by TAK-020 25 mg, CCT, orally, under fed, once on Day 1 of second intervention period.
9118|NCT02723201|B1|Baseline|Part 1: TAK-020 17.5 mg|TAK-020 17.5 mg, OS, under fasted state, once on Day 1 of first intervention period; followed by 7 days washout period, followed by TAK-020 17.5 mg, CCT, orally, under fasted state, once on Day 1 of second intervention period; followed by 7 days washout period, followed by TAK-020 17.5 mg, SDT, orally, under fasted state, once on Day 1 of third intervention period; followed by 7 days washout period, followed by TAK-020 17.5 mg, IRT, orally, under fasted state, once on Day 1 of fourth intervention period.
9119|NCT02723201|P3|Participant Flow|Part 2- TAK-020 25 mg CCT: Fed + Fasted|TAK-020 25 mg, CCT, orally, under fed state, once on Day 1 of first intervention period, followed by 7 days of washout period, further followed by TAK-020 25 mg, CCT, orally, under fasted state, once on Day 1 of second intervention period.
9120|NCT02723201|P2|Participant Flow|Part 2- TAK-020 25 mg CCT: Fasted + Fed|TAK-020 25 mg, CCT, orally, under fasted state, once on Day 1 of first intervention period, followed by 7 days of washout period, further followed by TAK-020 25 mg, CCT, orally, under fed, once on Day 1 of second intervention period.
9121|NCT02723201|P1|Participant Flow|Part 1- TAK-020 17.5 mg: OS + CCT + SDT + IRT|TAK-020 17.5 milligram (mg), oral solution (OS), under fasted state, once on Day 1 of first intervention period; followed by 7 days washout period, followed by TAK-020 17.5 mg, CCT, orally, under fasted state, once on Day 1 of second intervention period; followed by 7 days washout period, followed by TAK-020 17.5 mg, solid dispersion tablets (SDT), orally, under fasted state, once on Day 1 of third intervention period; followed by 7 days washout period, followed by TAK-020 17.5 mg, immediate release tablets (IRT), orally, under fasted state, once on Day 1 of fourth intervention period.
9122|NCT02723201|O6|Outcome|Part 2: TAK-020 25 mg CCT Fed|TAK-020 25 mg, CCT, orally under fed state, once on Day 1 of either first intervention period or second intervention period.
9123|NCT02723201|O5|Outcome|Part 2: TAK-020 25 mg CCT Fasted|TAK-020 25 mg, CCT, orally under fasted state, once on Day 1 of either first intervention period or second intervention period.
9124|NCT02723201|O4|Outcome|Part 1: TAK-020 17.5 mg IRT|TAK-020 17.5 mg, IRT, orally under fasted state, once on Day 1 of fourth intervention period.
9125|NCT02723201|O3|Outcome|Part 1: TAK-020 17.5 mg SDT|TAK-020 17.5 mg, SDT, orally under fasted state, once on Day 1 of third intervention period. A washout period of 7 day was maintained between each intervention period.
9126|NCT02723201|O2|Outcome|Part 1: TAK-020 17.5 mg CCT|TAK-020 17.5 mg, CCT, orally under fasted state, once on Day 1 of second intervention period. A washout period of 7 day was maintained between each intervention period.
9127|NCT02723201|O1|Outcome|Part 1: TAK-020 17.5 mg OS|TAK-020 17.5 mg, OS, once under fasted state on Day 1 of first intervention period. A washout period of 7 day was maintained between each intervention period.
9128|NCT02723201|O6|Outcome|Part 2: TAK-020 25 mg CCT Fed|TAK-020 25 mg, CCT, orally under fed state, once on Day 1 of either first intervention period or second intervention period.
9129|NCT02723201|O5|Outcome|Part 2: TAK-020 25 mg CCT Fasted|TAK-020 25 mg, CCT, orally under fasted state, once on Day 1 of either first intervention period or second intervention period.
9130|NCT02723201|O4|Outcome|Part 1: TAK-020 17.5 mg IRT|TAK-020 17.5 mg, IRT, orally under fasted state, once on Day 1 of fourth intervention period.
9131|NCT02723201|O3|Outcome|Part 1: TAK-020 17.5 mg SDT|TAK-020 17.5 mg, SDT, orally under fasted state, once on Day 1 of third intervention period. A washout period of 7 day was maintained between each intervention period.
9132|NCT02723201|O2|Outcome|Part 1: TAK-020 17.5 mg CCT|TAK-020 17.5 mg, CCT, orally under fasted state, once on Day 1 of second intervention period. A washout period of 7 day was maintained between each intervention period.
9133|NCT02723201|O1|Outcome|Part 1: TAK-020 17.5 mg OS|TAK-020 17.5 mg, OS, once under fasted state on Day 1 of first intervention period. A washout period of 7 day was maintained between each intervention period.
9134|NCT02723201|O6|Outcome|Part 2: TAK-020 25 mg CCT Fed|TAK-020 25 mg, CCT, orally under fed state, once on Day 1 of either first intervention period or second intervention period.
9135|NCT02723201|O5|Outcome|Part 2: TAK-020 25 mg CCT Fasted|TAK-020 25 mg, CCT, orally under fasted state, once on Day 1 of either first intervention period or second intervention period.
9136|NCT02723201|O4|Outcome|Part 1: TAK-020 17.5 mg IRT|TAK-020 17.5 mg, IRT, orally under fasted state, once on Day 1 of fourth intervention period.
9360|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
9137|NCT02723201|O3|Outcome|Part 1: TAK-020 17.5 mg SDT|TAK-020 17.5 mg, SDT, orally under fasted state, once on Day 1 of third intervention period. A washout period of 7 day was maintained between each intervention period.
9138|NCT02723201|O2|Outcome|Part 1: TAK-020 17.5 mg CCT|TAK-020 17.5 mg, CCT, orally under fasted state, once on Day 1 of second intervention period. A washout period of 7 day was maintained between each intervention period.
9139|NCT02723201|O1|Outcome|Part 1: TAK-020 17.5 mg OS|TAK-020 17.5 mg, OS, once under fasted state on Day 1 of first intervention period. A washout period of 7 day was maintained between each intervention period.
9140|NCT02723201|O6|Outcome|Part 2: TAK-020 25 mg CCT Fed|TAK-020 25 mg, CCT, orally under fed state, once on Day 1 of either first intervention period or second intervention period.
9141|NCT02723201|O5|Outcome|Part 2: TAK-020 25 mg CCT Fasted|TAK-020 25 mg, CCT, orally under fasted state, once on Day 1 of either first intervention period or second intervention period.
9142|NCT02723201|O4|Outcome|Part 1: TAK-020 17.5 mg IRT|TAK-020 17.5 mg, IRT, orally under fasted state, once on Day 1 of fourth intervention period.
9143|NCT02723201|O3|Outcome|Part 1: TAK-020 17.5 mg SDT|TAK-020 17.5 mg, SDT, orally under fasted state, once on Day 1 of third intervention period. A washout period of 7 day was maintained between each intervention period.
9144|NCT02723201|O2|Outcome|Part 1: TAK-020 17.5 mg CCT|TAK-020 17.5 mg, CCT, orally under fasted state, once on Day 1 of second intervention period. A washout period of 7 day was maintained between each intervention period.
9145|NCT02723201|O1|Outcome|Part 1: TAK-020 17.5 mg OS|TAK-020 17.5 mg, OS, once under fasted state on Day 1 of first intervention period. A washout period of 7 day was maintained between each intervention period.
9146|NCT02723201|O6|Outcome|Part 2: TAK-020 25 mg CCT Fed|TAK-020 25 mg, CCT, orally under fed state, once on Day 1 of either first intervention period or second intervention period.
9147|NCT02723201|O5|Outcome|Part 2: TAK-020 25 mg CCT Fasted|TAK-020 25 mg, CCT, orally under fasted state, once on Day 1 of either first intervention period or second intervention period.
9148|NCT02723201|O4|Outcome|Part 1: TAK-020 17.5 mg IRT|TAK-020 17.5 mg, IRT, orally under fasted state, once on Day 1 of fourth intervention period.
9149|NCT02723201|O3|Outcome|Part 1: TAK-020 17.5 mg SDT|TAK-020 17.5 mg, SDT, orally under fasted state, once on Day 1 of third intervention period. A washout period of 7 day was maintained between each intervention period.
9150|NCT02723201|O2|Outcome|Part 1: TAK-020 17.5 mg CCT|TAK-020 17.5 mg, CCT, orally under fasted state, once on Day 1 of second intervention period. A washout period of 7 day was maintained between each intervention period.
9151|NCT02723201|O1|Outcome|Part 1: TAK-020 17.5 mg OS|TAK-020 17.5 mg, OS, once under fasted state on Day 1 of first intervention period. A washout period of 7 day was maintained between each intervention period.
9152|NCT02723201|O6|Outcome|Part 2: TAK-020 25 mg CCT Fed|TAK-020 25 mg, CCT, orally under fed state, once on Day 1 of either first intervention period or second intervention period.
9153|NCT02723201|O5|Outcome|Part 2: TAK-020 25 mg CCT Fasted|TAK-020 25 mg, CCT, orally under fasted state, once on Day 1 of either first intervention period or second intervention period.
9154|NCT02723201|O4|Outcome|Part 1: TAK-020 17.5 mg IRT|TAK-020 17.5 mg, IRT, orally under fasted state, once on Day 1 of fourth intervention period.
9155|NCT02723201|O3|Outcome|Part 1: TAK-020 17.5 mg SDT|TAK-020 17.5 mg, SDT, orally under fasted state, once on Day 1 of third intervention period. A washout period of 7 day was maintained between each intervention period.
9156|NCT02723201|O2|Outcome|Part 1: TAK-020 17.5 mg CCT|TAK-020 17.5 mg, CCT, orally under fasted state, once on Day 1 of second intervention period. A washout period of 7 day was maintained between each intervention period.
9157|NCT02723201|O1|Outcome|Part 1: TAK-020 17.5 mg OS|TAK-020 17.5 mg, OS, once under fasted state on Day 1 of first intervention period. A washout period of 7 day was maintained between each intervention period.
9158|NCT02723201|O6|Outcome|Part 2: TAK-020 25 mg CCT Fed|TAK-020 25 mg, CCT, orally under fed state, once on Day 1 of either first intervention period or second intervention period.
9159|NCT02723201|O5|Outcome|Part 2: TAK-020 25 mg CCT Fasted|TAK-020 25 mg, CCT, orally under fasted state, once on Day 1 of either first intervention period or second intervention period.
9160|NCT02723201|O4|Outcome|Part 1: TAK-020 17.5 mg IRT|TAK-020 17.5 mg, IRT, orally under fasted state, once on Day 1 of fourth intervention period.
9161|NCT02723201|O3|Outcome|Part 1: TAK-020 17.5 mg SDT|TAK-020 17.5 mg, SDT, orally under fasted state, once on Day 1 of third intervention period. A washout period of 7 day was maintained between each intervention period.
9162|NCT02723201|O2|Outcome|Part 1: TAK-020 17.5 mg CCT|TAK-020 17.5 mg, CCT, orally under fasted state, once on Day 1 of second intervention period. A washout period of 7 day was maintained between each intervention period.
9163|NCT02723201|O1|Outcome|Part 1: TAK-020 17.5 mg OS|TAK-020 17.5 mg, OS, once under fasted state on Day 1 of first intervention period. A washout period of 7 day was maintained between each intervention period.
9164|NCT02723201|O6|Outcome|Part 2: TAK-020 25 mg CCT Fed|TAK-020 25 mg, CCT, orally under fed state, once on Day 1 of either first intervention period or second intervention period.
9165|NCT02723201|O5|Outcome|Part 2: TAK-020 25 mg CCT Fasted|TAK-020 25 mg, CCT, orally under fasted state, once on Day 1 of either first intervention period or second intervention period.
9166|NCT02723201|O4|Outcome|Part 1: TAK-020 17.5 mg IRT|TAK-020 17.5 mg, IRT, orally under fasted state, once on Day 1 of fourth intervention period.
9167|NCT02723201|O3|Outcome|Part 1: TAK-020 17.5 mg SDT|TAK-020 17.5 mg, SDT, orally under fasted state, once on Day 1 of third intervention period. A washout period of 7 day was maintained between each intervention period.
9168|NCT02723201|O2|Outcome|Part 1: TAK-020 17.5 mg CCT|TAK-020 17.5 mg, CCT, orally under fasted state, once on Day 1 of second intervention period. A washout period of 7 day was maintained between each intervention period.
9169|NCT02723201|O1|Outcome|Part 1: TAK-020 17.5 mg OS|TAK-020 17.5 mg, OS, once under fasted state on Day 1 of first intervention period. A washout period of 7 day was maintained between each intervention period.
9170|NCT02723201|E6|Reported Event|Part 2: TAK-020 25 mg CCT Fed|TAK-020 25 mg, CCT, orally under fed state, once on Day 1 of either first intervention period or second intervention period.
9171|NCT02723201|E5|Reported Event|Part 2: TAK-020 25 mg CCT Fasted|TAK-020 25 mg, CCT, orally under fasted state, once on Day 1 of either first intervention period or second intervention period.
9173|NCT02723201|E3|Reported Event|Part 1: TAK-020 17.5 mg SDT|TAK-020 17.5 mg, SDT, orally under fasted state, once on Day 1 of third intervention period. A washout period of 7 day was maintained between each intervention period.
9174|NCT02723201|E2|Reported Event|Part 1: TAK-020 17.5 mg CCT|TAK-020 17.5 mg, CCT, orally under fasted state, once on Day 1 of second intervention period. A washout period of 7 day was maintained between each intervention period.
9175|NCT02723201|E1|Reported Event|Part 1: TAK-020 17.5 mg OS|TAK-020 17.5 mg, OS, once under fasted state on Day 1 of first intervention period. A washout period of 7 day was maintained between each intervention period.
9176|NCT02723188|B4|Baseline|Total|Total of all reporting groups
9177|NCT02723188|B3|Baseline|AC: Alternating Current|"Alternating current electrical stimulation~AC stimulation (1.5 milliampere,1.5 Hertz frequency)"
9178|NCT02723188|B2|Baseline|DC: Direct Current|"Direct current electrical stimulation~DC stimulation (1.5 milliampere, 20 minutes)"
9179|NCT02723188|B1|Baseline|Sham|"Sham electrical stimulation~Sham stimulation (1.5 milliampere,30 seconds)"
9180|NCT02723188|P3|Participant Flow|AC (Alternating Current)|"Alternating current electrical stimulation~AC stimulation (1.5 milliampere,1.5 Hertz frequency)"
9181|NCT02723188|P2|Participant Flow|DC (Direct Current)|"Direct current electrical stimulation~DC stimulation (1.5 milliampere, 20 minutes)"
9182|NCT02723188|P1|Participant Flow|Sham|"Sham electrical stimulation~Sham stimulation (1.5 milliampere,30 seconds)"
9183|NCT02723188|O3|Outcome|AC: Alternating Current|"Alternating current electrical stimulation~AC stimulation (1.5 milliampere,1.5 Hertz frequency)"
9184|NCT02723188|O2|Outcome|DC: Direct Current|"Direct current electrical stimulation~DC stimulation (1.5 milliampere, 20 minutes)"
9185|NCT02723188|O1|Outcome|Sham|"Sham electrical stimulation~Sham stimulation (1.5 milliampere,30 seconds)"
9186|NCT02723188|O3|Outcome|AC: Alternating Current|"Alternating current electrical stimulation~AC stimulation (1.5 milliampere,1.5 Hertz frequency)"
9187|NCT02723188|O2|Outcome|DC: Direct Current|"Direct current electrical stimulation~DC stimulation (1.5 milliampere, 20 minutes)"
9188|NCT02723188|O1|Outcome|Sham|"Sham electrical stimulation~Sham stimulation (1.5 milliampere,30 seconds)"
9189|NCT02723188|E3|Reported Event|AC: Alternating Current|"Alternating current electrical stimulation~AC stimulation (1.5 milliampere,1.5 Hertz frequency)"
9190|NCT02723188|E2|Reported Event|DC: Direct Current|"Direct current electrical stimulation~DC stimulation (1.5 milliampere, 20 minutes)"
9191|NCT02723188|E1|Reported Event|Sham|"Sham electrical stimulation~Sham stimulation (1.5 milliampere,30 seconds)"
9192|NCT02722967|B4|Baseline|Total|Total of all reporting groups
9193|NCT02722967|B3|Baseline|Schizophrenia (SCH)|This group consisted of the participants with schizophrenia who were treated with oral aripiprazole.
9194|NCT02722967|B2|Baseline|Major Depressive Disorder (MDD)|This group consisted of the participants with adjunctive treatment of major depressive disorder who were treated with oral aripiprazole.
9195|NCT02722967|B1|Baseline|Bipolar 1 Disorder (BP1)|This group consisted of the participants with acute treatment of manic and mixed episodes associated with bipolar 1 disorder who were treated with oral aripiprazole.
9196|NCT02722967|P3|Participant Flow|Schizophrenia (SCH)|This group consisted of the participants with SCH who were being treated with oral aripiprazole.
9197|NCT02722967|P2|Participant Flow|Major Depressive Disorder (MDD)|This group consisted of the participants with adjunctive treatment of MDD who were being treated with oral aripiprazole.
9198|NCT02722967|P1|Participant Flow|Bipolar 1 Disorder (BP1)|This group consisted of the participants with acute treatment of manic and mixed episodes associated with BP1 who were being treated with oral aripiprazole.
9199|NCT02722967|O3|Outcome|Schizophrenia (SCH)|This group consisted of the participants with schizophrenia who were treated with oral aripiprazole.
9200|NCT02722967|O2|Outcome|Major Depressive Disorder (MDD)|This group consisted of the participants with adjunctive treatment of major depressive disorder who were treated with oral aripiprazole.
9201|NCT02722967|O1|Outcome|Bipolar 1 Disorder (BP1)|This group consisted of the participants with acute treatment of manic and mixed episodes associated with bipolar 1 disorder who were treated with oral aripiprazole
9202|NCT02722967|E3|Reported Event|Schizophrenia (SCH)|This group consisted of the participants with SCH who were being treated with oral aripiprazole.
9203|NCT02722967|E2|Reported Event|Major Depressive Disorder (MDD)|This group consisted of the participants with adjunctive treatment of MDD who were being treated with oral aripiprazole.
9204|NCT02722967|E1|Reported Event|Bipolar 1 Disorder (BP1)|This group consisted of the participants with acute treatment of manic and mixed episodes associated with BP1 who were being treated with oral aripiprazole.
9205|NCT02722564|B1|Baseline|All Study Participants|"subject will self estimate breath alcohol content after each beer ingested~self estimation of breath alcohol content~record breath alcohol content as measured by breathalyzer~drink a beer: drink a beer, repeat until breath alcohol content 0.1"
9206|NCT02722564|P1|Participant Flow|All Study Participants|"subject will self estimate breath alcohol content after each beer ingested~self estimation of breath alcohol content~record breath alcohol content as measured by breathalyzer~drink a beer: drink a beer, repeat until breath alcohol content 0.1"
9207|NCT02722564|O1|Outcome|All Study Participants|"subject will self estimate breath alcohol content after each beer ingested~self estimation of breath alcohol content~record breath alcohol content as measured by breathalyzer~drink a beer: drink a beer, repeat until breath alcohol content 0.1"
9208|NCT02722564|E1|Reported Event|All Study Participants|"subject will self estimate breath alcohol content after each beer ingested~self estimation of breath alcohol content~record breath alcohol content as measured by breathalyzer~drink a beer: drink a beer, repeat until breath alcohol content 0.1"
9209|NCT02722278|B3|Baseline|Total|Total of all reporting groups
9225|NCT02722239|O2|Outcome|Reference Product (R)|Reference product (R): co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long).
9226|NCT02722239|O1|Outcome|Test Product (T)|Test Product (T): a single oral dose of modified release fixed dose combination film-coated tablet consisting of 10 mg dapagliflozin IR and 1000 mg metformin hydrochloride extended release.
9210|NCT02722278|B2|Baseline|Axiron Testosterone Topical Solution|"Subjects randomly assigned to the Axiron treatment group will begin treatment at a dose of 60 mg every morning.~Axiron Testosterone Topical Solution: Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only.~Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL."
9211|NCT02722278|B1|Baseline|Oral Testosterone Undecanoate|"Approximately 135 subjects will receive oral TU treatment during the study for approximately 3.5 months. Subjects randomly assigned to the oral TU treatment group will begin treatment at a dose of 237 mg TU twice daily (BID).~Oral Testosterone Undecanoate: Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL."
9212|NCT02722278|P2|Participant Flow|Axiron Testosterone Topical Solution|"56 subjects were randomly assigned to the Axiron treatment group and began treatment at a dose of 60 mg every morning.~Axiron Testosterone Topical Solution: Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only.~Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL."
9213|NCT02722278|P1|Participant Flow|Oral Testosterone Undecanoate|"166 subjects received oral TU treatment during the study for approximately 3.5 months. Subjects randomly assigned to the oral TU treatment group will begin treatment at a dose of 237 mg TU twice daily (BID).~Oral Testosterone Undecanoate: Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL."
9214|NCT02722278|O2|Outcome|Axiron Cosyntropin Substudy Subjects|
9215|NCT02722278|O1|Outcome|Oral TU Cosyntropin Substudy Subjects|Subjects receiving Oral TU participating in cosyntropin substudy
9216|NCT02722278|O2|Outcome|Axiron Testosterone Topical Solution|"56 subjects were randomly assigned to the Axiron treatment group and began treatment at a dose of 60 mg every morning.~Axiron Testosterone Topical Solution: Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only.~Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL."
9217|NCT02722278|O1|Outcome|Oral Testosterone Undecanoate|"166 subjects received oral TU treatment during the study for approximately 3.5 months. Subjects randomly assigned to the oral TU treatment group will begin treatment at a dose of 237 mg TU twice daily (BID).~Oral Testosterone Undecanoate: Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL."
9218|NCT02722278|E2|Reported Event|Axiron Testosterone Topical Solution|"56 subjects were randomly assigned to the Axiron treatment group and began treatment at a dose of 60 mg every morning.~Axiron Testosterone Topical Solution: Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only.~Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL."
9219|NCT02722278|E1|Reported Event|Oral Testosterone Undecanoate|"166 subjects received oral TU treatment during the study for approximately 3.5 months. Subjects randomly assigned to the oral TU treatment group will begin treatment at a dose of 237 mg TU twice daily (BID).~Oral Testosterone Undecanoate: Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL."
9220|NCT02722239|B3|Baseline|Total|Total of all reporting groups
9221|NCT02722239|B2|Baseline|R Drug First / Then Drug T|Reference product (R): co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long). Volunteers from group 2 were administered with the study drug in reverse order. It means that group 1 took the study products in sequence T-R and group 2 in the sequence R-T.
9222|NCT02722239|B1|Baseline|T Drug First / Then Drug R|Test product (T): a single oral dose of modified release fixed dose combination film-coated tablet consisting of 10 mg dapagliflozin IR and 1000 mg metformin hydrochloride extended release. Volunteers enrolled to group 1, on the first study period took the study test product (Т), and on the second study period after wash out period of 7 days the volunteers were given the Reference product (R)
9223|NCT02722239|P2|Participant Flow|R Drug First / Then Drug T|Reference product (R): co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long). Volunteers from group 2 were administered with the study drug in reverse order. It means that group 1 took the study products in sequence T-R and group 2 in the sequence R-T.
9224|NCT02722239|P1|Participant Flow|T Drug First / Then Drug R|Test product (T): a single oral dose of modified release fixed dose combination film-coated tablet consisting of 10 mg dapagliflozin IR and 1000 mg metformin hydrochloride extended release. Volunteers enrolled to group 1, on the first study period took the study test product (Т), and on the second study period after wash out period of 7 days the volunteers were given the Reference product (R)
9227|NCT02722239|O1|Outcome|T Drug vs R Drug|Ratio of Test product (a single oral dose of modified release fixed dose combination film-coated tablet consisting of 10 mg dapagliflozin IR and 1000 mg metformin hydrochloride extended release) and Reference product (co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long)).
9228|NCT02722239|O2|Outcome|Reference Product (R)|Reference product (R): co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long).
9229|NCT02722239|O1|Outcome|Test Product (T)|Test Product (T): a single oral dose of modified release fixed dose combination film-coated tablet consisting of 10 mg dapagliflozin IR and 1000 mg metformin hydrochloride extended release.
9230|NCT02722239|O2|Outcome|Reference Product (R)|Reference product (R): co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long).
9231|NCT02722239|O1|Outcome|Test Product (T)|Test Product (T): a single oral dose of modified release fixed dose combination film-coated tablet consisting of 10 mg dapagliflozin IR and 1000 mg metformin hydrochloride extended release.
9232|NCT02722239|O2|Outcome|Reference Product (R)|Reference product (R): co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long).
9233|NCT02722239|O1|Outcome|Test Product (T)|Test Product (T): a single oral dose of modified release fixed dose combination film-coated tablet consisting of 10 mg dapagliflozin IR and 1000 mg metformin hydrochloride extended release.
9234|NCT02722239|E2|Reported Event|Reference Product (R)|Reference product (R): co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long).
9235|NCT02722239|E1|Reported Event|Test Product (T)|Test Product (T): a single oral dose of modified release fixed dose combination film-coated tablet consisting of 10 mg dapagliflozin IR and 1000 mg metformin hydrochloride extended release.
9236|NCT02722044|B1|Baseline|M923 40 mg|Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9237|NCT02722044|P1|Participant Flow|M923 40 mg|Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9238|NCT02722044|O1|Outcome|M923 40 mg|Participants self-administered 40 mg of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9239|NCT02722044|O1|Outcome|M923 40 mg|Participants self-administered 40 mg of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9240|NCT02722044|O1|Outcome|M923 40 mg|Participants self-administered 40 mg of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9241|NCT02722044|O1|Outcome|M923 40 mg|Participants self-administered 40 mg of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9242|NCT02722044|O1|Outcome|M923 40 mg|Participants self-administered 40 mg of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9243|NCT02722044|O1|Outcome|M923 40 mg|Participants self-administered 40 mg of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9244|NCT02722044|O1|Outcome|M923 40 mg|Participants self-administered 40 mg of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9245|NCT02722044|O1|Outcome|M923 40 mg|Participants self-administered 40 mg of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9246|NCT02722044|O1|Outcome|M923 40 mg|Participants self-administered 40 mg of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9247|NCT02722044|O1|Outcome|M923 40 mg|Participants self-administered 40 mg of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9248|NCT02722044|O1|Outcome|M923 40 mg|Participants self-administered 40 mg of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9249|NCT02722044|O1|Outcome|M923 40 mg|Participants self-administered 40 mg of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9250|NCT02722044|O1|Outcome|M923 40 mg|Participants self-administered 40 mg of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9251|NCT02722044|O1|Outcome|M923 40 mg|Participants self-administered 40 mg of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9252|NCT02722044|O1|Outcome|M923 40 mg|Participants self-administered 40 mg of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9253|NCT02722044|O1|Outcome|M923 40 mg|Participants self-administered 40 mg of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9254|NCT02722044|O1|Outcome|M923 40 mg|Participants self-administered 40 mg of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9255|NCT02722044|O1|Outcome|M923 40 mg|Participants self-administered 40 mg of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9256|NCT02722044|O1|Outcome|M923 40 mg|Participants self-administered 40 mg of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9257|NCT02722044|O1|Outcome|M923 40 mg|Participants self-administered 40 mg of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9258|NCT02722044|O1|Outcome|M923 40 mg|Participants self-administered 40 mg of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9259|NCT02722044|O1|Outcome|M923 40 mg|Participants self-administered 40 mg of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9260|NCT02722044|O1|Outcome|M923 40 mg|Participants self-administered 40 mg of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9261|NCT02722044|O1|Outcome|M923 40 mg|Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9262|NCT02722044|E1|Reported Event|M923 40 mg|Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
9263|NCT02721641|B1|Baseline|Herceptin|Participants received IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. Herceptin was administered at the discretion of the investigator as either 2 mg/kg once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
9264|NCT02721641|P1|Participant Flow|Herceptin|Participants received intravenous (IV) Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. Herceptin was administered at the discretion of the investigator as either 2 milligrams per kilogram (mg/kg) once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
9265|NCT02721641|O1|Outcome|Herceptin|Participants received IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. Herceptin was administered at the discretion of the investigator as either 2 mg/kg once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
9266|NCT02721641|O1|Outcome|Herceptin|Participants received IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. Herceptin was administered at the discretion of the investigator as either 2 mg/kg once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
9267|NCT02721641|O1|Outcome|Herceptin|Participants received IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. Herceptin was administered at the discretion of the investigator as either 2 mg/kg once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
9268|NCT02721641|E1|Reported Event|Herceptin|Participants received IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. Herceptin was administered at the discretion of the investigator as either 2 mg/kg once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
9269|NCT02721277|B1|Baseline|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9270|NCT02721277|P1|Participant Flow|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9271|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9272|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9310|NCT02718898|P2|Participant Flow|Ixekizumab 80mg Q2W|Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
20048|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
9273|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9274|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9275|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9276|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9277|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9278|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9279|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9311|NCT02718898|P1|Participant Flow|Placebo|Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
9312|NCT02718898|O2|Outcome|Ixekizumab 80mg Q2W|Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
9313|NCT02718898|O1|Outcome|Placebo|Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
17623|NCT02577107|O1|Outcome|Ranibizumab 0.5 mg|Three monthly injections of 0.5mg Ranibizumab
9280|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9281|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9282|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9283|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9284|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9285|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9286|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9314|NCT02718898|O2|Outcome|Ixekizumab 80mg Q2W|Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
9315|NCT02718898|O1|Outcome|Placebo|Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
9316|NCT02718898|O2|Outcome|Ixekizumab 80mg Q2W|Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
9287|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9288|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9289|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9290|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9291|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9292|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9293|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9317|NCT02718898|O1|Outcome|Placebo|Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
9318|NCT02718898|O2|Outcome|Ixekizumab 80mg Q2W|Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
9319|NCT02718898|O1|Outcome|Placebo|Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
9361|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
9294|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9295|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9296|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9297|NCT02721277|E1|Reported Event|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
9298|NCT02720952|B1|Baseline|Infacort|"Infacort® is a dry granule formulation of hydrocortisone stored in capsules that will be available in different strengths (0.5, 1.0, 2.0 and 5.0mg).~The clinically-appropriate dose, based on standard individualised treatment, will be administered, given as a single dose orally. This will usually be equivalent to the previous day’s dose.~Infacort®: dry granule formulation of hydrocortisone"
9299|NCT02720952|P1|Participant Flow|Infacort|"Infacort® is a dry granule formulation of hydrocortisone stored in capsules that will be available in different strengths (0.5, 1.0, 2.0 and 5.0mg).~The clinically-appropriate dose, based on standard individualised treatment, will be administered, given as a single dose orally. This will usually be equivalent to the previous day’s dose.~Infacort®: dry granule formulation of hydrocortisone"
9300|NCT02720952|O4|Outcome|Question 4|Percentage of parents/carers that agreed, or strongly agreed with the statement: Overall, I would prefer Infacort for my child over the usual hydrocortisone medication.
9301|NCT02720952|O3|Outcome|Question 3|Percentage of parents/carers that agreed, or strongly agreed with the statement: I would be happy to give my child Infacort in the future.
9302|NCT02720952|O2|Outcome|Question 2|Percentage of parents/carers that agreed, or strongly agreed with the statement: My child showed a positive reaction after Infacort was given.
9303|NCT02720952|O1|Outcome|Question 1|Percentage of parents/carers that agreed, or strongly agreed with the statement: My child found swallowing easy.
9304|NCT02720952|O1|Outcome|Infacort|"Infacort® is a dry granule formulation of hydrocortisone stored in capsules that will be available in different strengths (0.5, 1.0, 2.0 and 5.0mg).~The clinically-appropriate dose, based on standard individualised treatment, will be administered, given as a single dose orally. This will usually be equivalent to the previous day’s dose.~Infacort®: dry granule formulation of hydrocortisone"
9305|NCT02720952|O1|Outcome|Infacort|"Infacort® is a dry granule formulation of hydrocortisone stored in capsules that will be available in different strengths (0.5, 1.0, 2.0 and 5.0mg).~The clinically-appropriate dose, based on standard individualised treatment, will be administered, given as a single dose orally. This will usually be equivalent to the previous day’s dose.~Infacort®: dry granule formulation of hydrocortisone"
9306|NCT02720952|E1|Reported Event|Infacort|"Infacort® is a dry granule formulation of hydrocortisone stored in capsules that will be available in different strengths (0.5, 1.0, 2.0 and 5.0mg).~The clinically-appropriate dose, based on standard individualised treatment, will be administered, given as a single dose orally. This will usually be equivalent to the previous day’s dose.~Infacort®: dry granule formulation of hydrocortisone"
9307|NCT02718898|B3|Baseline|Total|Total of all reporting groups
9308|NCT02718898|B2|Baseline|Ixekizumab 80mg Q2W|Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
9309|NCT02718898|B1|Baseline|Placebo|Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
9356|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
9320|NCT02718898|O2|Outcome|Ixekizumab 80mg Q2W|Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
9321|NCT02718898|O1|Outcome|Placebo|Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
9322|NCT02718898|O2|Outcome|Ixekizumab 80mg Q2W|Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
9323|NCT02718898|O1|Outcome|Placebo|Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
9324|NCT02718898|O2|Outcome|Ixekizumab Q2W|Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
9325|NCT02718898|O1|Outcome|Placebo|Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
9326|NCT02718898|O2|Outcome|Ixekizumab 80mg Q2W|Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
9327|NCT02718898|O1|Outcome|Placebo|Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
9328|NCT02718898|O2|Outcome|Ixekizumab 80mg Q2W|Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
9329|NCT02718898|O1|Outcome|Placebo|Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
9330|NCT02718898|O2|Outcome|Ixekizumab 80mg Q2W|Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
9331|NCT02718898|O1|Outcome|Placebo|Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
9332|NCT02718898|O2|Outcome|Ixekizumab 80mg Q2W|Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
9333|NCT02718898|O1|Outcome|Placebo|Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
9334|NCT02718898|O2|Outcome|Ixekizumab 80mg Q2W|Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
9335|NCT02718898|O1|Outcome|Placebo|Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
9336|NCT02718898|E2|Reported Event|Ixekizumab 80mg Q2W|Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
9337|NCT02718898|E1|Reported Event|Placebo|Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
9338|NCT02717754|B7|Baseline|Total|Total of all reporting groups
9339|NCT02717754|B6|Baseline|Oseltamivir 200 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 200 mg intravenous BID for 5 days but received incorrect infusion duration.
9340|NCT02717754|B5|Baseline|Oseltamivir 100 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 100 mg intravenous BID for 5 days but received incorrect infusion duration.
9341|NCT02717754|B4|Baseline|Placebo (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir matched placebo intravenous BID for 5 days but received incorrect infusion duration.
9342|NCT02717754|B3|Baseline|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
9343|NCT02717754|B2|Baseline|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
9344|NCT02717754|B1|Baseline|Placebo|Participants received oseltamivir matched placebo BID for 5 days.
9345|NCT02717754|P6|Participant Flow|Oseltamivir 200 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 200 mg intravenous BID for 5 days but received incorrect infusion duration.
9346|NCT02717754|P5|Participant Flow|Oseltamivir 100 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 100 mg intravenous BID for 5 days but received incorrect infusion duration.
9347|NCT02717754|P4|Participant Flow|Placebo (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir matched placebo intravenous BID for 5 days but received incorrect infusion duration.
9348|NCT02717754|P3|Participant Flow|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
9349|NCT02717754|P2|Participant Flow|Oseltamivir 100 mg|Participants received 100 milligrams (mg) oseltamivir intravenous BID for 5 days.
9350|NCT02717754|P1|Participant Flow|Placebo|Participants received oseltamivir matched placebo twice daily (BID) for 5 days.
9351|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
9352|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
9353|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
9354|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
9355|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
20049|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
9362|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
9363|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
9364|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
9365|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
9366|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
9367|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
9368|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
9369|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
9370|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
9371|NCT02717754|E6|Reported Event|Oseltamivir 200 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 200 mg intravenous BID for 5 days but received incorrect infusion duration.
9372|NCT02717754|E5|Reported Event|Oseltamivir 100 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 100 mg intravenous BID for 5 days but received incorrect infusion duration.
9373|NCT02717754|E4|Reported Event|Placebo (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir matched placebo intravenous BID for 5 days but received incorrect infusion duration.
9374|NCT02717754|E3|Reported Event|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
9375|NCT02717754|E2|Reported Event|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
9376|NCT02717754|E1|Reported Event|Placebo|Participants received oseltamivir matched placebo for 5 days.
9377|NCT02716779|B4|Baseline|Total|Total of all reporting groups
9378|NCT02716779|B3|Baseline|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9379|NCT02716779|B2|Baseline|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9380|NCT02716779|B1|Baseline|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9381|NCT02716779|P3|Participant Flow|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40 kilodalton [KD]) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg orally (PO) (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9382|NCT02716779|P2|Participant Flow|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40 kilodalton [KD]) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9428|NCT02716714|B1|Baseline|Ingenol Mebutate Gel 0.015%|"Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
9491|NCT02714062|O3|Outcome|VI-0521 Top Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)"
9383|NCT02716779|P1|Participant Flow|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40 kilodalton [KD]) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg orally (PO) (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9384|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9385|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9386|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9387|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9388|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9389|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9390|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9429|NCT02716714|P2|Participant Flow|Ingenol Mebutate Gel 0.05%|"Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
10061|NCT02699593|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens.
9391|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9392|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9393|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9394|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9395|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9396|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9397|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9398|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9430|NCT02716714|P1|Participant Flow|Ingenol Mebutate Gel 0.015%|"Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
20050|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
9399|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9400|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9401|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9402|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9403|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9404|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9405|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9406|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9431|NCT02716714|O2|Outcome|Non-CC Group|The participants who didn't achieved complete clearance of AK lesions in the selected treatment and the Non-CC group of Ingenol Mebutate Gel 0.015% and 0.05% was intended to be analyzed together.
9432|NCT02716714|O1|Outcome|CC Group|The participants who achieved complete clearance of AK lesions in the selected treatment and the CC group of Ingenol Mebutate Gel 0.015% and 0.05% was intended to be analyzed together.
20051|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
9407|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9408|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9409|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9410|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9411|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9412|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9413|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9414|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9433|NCT02716714|O2|Outcome|Non-CC Group|The participants who didn't achieved complete clearance of AK lesions in the selected treatment.
9434|NCT02716714|O1|Outcome|CC Group|The participants who achieved complete clearance of AK lesions in the selected treatment.
9492|NCT02714062|O2|Outcome|VI-0521 Mid Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)"
9493|NCT02714062|O1|Outcome|Placebo|Days 1-56: Placebo
9415|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9416|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9417|NCT02716779|O3|Outcome|Total Participant Group|Combined group of PEG IFN alfa-2a, matching placebo and ribavirin arms.
9418|NCT02716779|O2|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9419|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
9420|NCT02716779|E6|Reported Event|Ribavirin, Period 2 Combination Therapy|"In period 2 participants, who received ribavirin monotherapy in period 1, received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks."
9421|NCT02716779|E5|Reported Event|Placebo, Period 2 Combination Therapy|"In period 2 participants, who received placebo in period 1, received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks."
9422|NCT02716779|E4|Reported Event|PEG-IFN Alfa-2a, Period 2 Combination Therapy|"In period 2 participants, who received PEG-IFN monotherapy in period 1, received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks."
9423|NCT02716779|E3|Reported Event|Ribavirin, Period 1 Monotherapy|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks in period 1.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks."
9424|NCT02716779|E2|Reported Event|Placebo, Period 1 Monotherapy|"Participants with chronic hepatitis C, genotype 1, received placebo PO for 6 weeks in period 1.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks."
9425|NCT02716779|E1|Reported Event|PEG-IFN Alfa-2a, Period 1 Monotherapy|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks in period 1.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks."
9426|NCT02716714|B3|Baseline|Total|Total of all reporting groups
9427|NCT02716714|B2|Baseline|Ingenol Mebutate Gel 0.05%|"Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
9489|NCT02714062|O2|Outcome|VI-0521 Mid Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)"
9435|NCT02716714|O2|Outcome|Ingenol Mebutate Gel 0.05%|"Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
9436|NCT02716714|O1|Outcome|Ingenol Mebutate Gel 0.015%|"Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
9437|NCT02716714|O2|Outcome|Ingenol Mebutate Gel 0.05%|"Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
9438|NCT02716714|O1|Outcome|Ingenol Mebutate Gel 0.015%|"Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
9439|NCT02716714|O2|Outcome|Ingenol Mebutate Gel 0.05%|"Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
9440|NCT02716714|O1|Outcome|Ingenol Mebutate Gel 0.015%|"Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
9441|NCT02716714|O2|Outcome|Ingenol Mebutate Gel 0.05%|"Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
9442|NCT02716714|O1|Outcome|Ingenol Mebutate Gel 0.015%|"Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
9443|NCT02716714|O2|Outcome|Ingenol Mebutate Gel 0.05%|"Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
9444|NCT02716714|O1|Outcome|Ingenol Mebutate Gel 0.015%|"Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
9445|NCT02716714|O2|Outcome|Ingenol Mebutate Gel 0.05%|"Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
9446|NCT02716714|O1|Outcome|Ingenol Mebutate Gel 0.015%|"Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
9447|NCT02716714|O2|Outcome|Ingenol Mebutate Gel 0.05%|"Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
9448|NCT02716714|O1|Outcome|Ingenol Mebutate Gel 0.015%|"Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
9449|NCT02716714|O2|Outcome|Ingenol Mebutate Gel 0.05%|"Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
9450|NCT02716714|O1|Outcome|Ingenol Mebutate Gel 0.015%|"Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
9451|NCT02716714|O2|Outcome|Ingenol Mebutate Gel 0.05%|"Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
9452|NCT02716714|O1|Outcome|Ingenol Mebutate Gel 0.015%|"Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
9490|NCT02714062|O1|Outcome|Placebo|Days 1-56: Placebo
9453|NCT02716714|E2|Reported Event|Ingenol Mebutate Gel 0.05%|"Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
9454|NCT02716714|E1|Reported Event|Ingenol Mebutate Gel 0.015%|"Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
9455|NCT02716298|B1|Baseline|Overall Participants|"Study participants are randomized to wear fanfilcon A lens or lotrafilcon B lens for 1 month during the crossover study~fanfilcon A: contact lens lotrafilcon B: contact lens"
9456|NCT02716298|P2|Participant Flow|Lotrafilcon B Then Fanfilcon A|"Study participants are randomized to wear lotrafilcon B for 1 month, then fanfilcon A lens for 1 month during the crossover study.~lotrafilcon B: contact lens fanfilcon A: contact lens"
9457|NCT02716298|P1|Participant Flow|Fanfilcon A Then Lotrafilcon B|"Study participants are randomized to wear fanfilcon A lens for 1 month, then lotrafilcon B for 1 month during the crossover study~fanfilcon A: contact lens lotrafilcon B: contact lens"
9458|NCT02716298|O2|Outcome|Lotrafilcon B|"Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study.~lotrafilcon B: contact lens"
9459|NCT02716298|O1|Outcome|Fanfilcon A|"Study participants are randomized to wear fanfilcon A lens for 1 month during the crossover study~fanfilcon A: contact lens"
9460|NCT02716298|O2|Outcome|Lotrafilcon B|"Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study.~lotrafilcon B: contact lens"
9461|NCT02716298|O1|Outcome|Fanfilcon A|"Study participants are randomized to wear fanfilcon A lens for 1 month during the crossover study~fanfilcon A: contact lens"
9462|NCT02716298|O5|Outcome|Strongly Prefer Lotrafilcon B|"Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study~lotrafilcon B: contact lens"
9463|NCT02716298|O4|Outcome|Slightly Prefer Lotrafilcon B|"Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study~lotrafilcon B: contact lens"
9464|NCT02716298|O3|Outcome|No Preference|
9465|NCT02716298|O2|Outcome|Slightly Prefer Fanfilcon A|"Study participants are randomized to wear fanfilcon A lens for 1 month during the crossover study~fanfilcon A: contact lens"
9466|NCT02716298|O1|Outcome|Strongly Prefer Fanfilcon A|"Study participants are randomized to wear fanfilcon A lens for 1 month during the crossover study~fanfilcon A: contact lens"
9467|NCT02716298|O2|Outcome|Lotrafilcon B|"Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study.~lotrafilcon B: contact lens"
9468|NCT02716298|O1|Outcome|Fanfilcon A|"Study participants are randomized to wear fanfilcon A lens for 1 month during the crossover study~fanfilcon A: contact lens"
9469|NCT02716298|E2|Reported Event|Lotrafilcon B|"Study participants are randomized to wear lotrafilcon B lens during the crossover study.~lotrafilcon B: contact lens"
9470|NCT02716298|E1|Reported Event|Fanfilcon A|"Study participants are randomized to wear fanfilcon A lens during the crossover study~fanfilcon A: contact lens"
9471|NCT02714062|B4|Baseline|Total|Total of all reporting groups
9472|NCT02714062|B3|Baseline|VI-0521 Top Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)"
9473|NCT02714062|B2|Baseline|VI-0521 Mid Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)"
9474|NCT02714062|B1|Baseline|Placebo|Days 1-56: Placebo
9475|NCT02714062|P3|Participant Flow|VI-0521 Top Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)"
9476|NCT02714062|P2|Participant Flow|VI-0521 Mid Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)"
9477|NCT02714062|P1|Participant Flow|Placebo|Days 1-56: Placebo
9478|NCT02714062|O3|Outcome|VI-0521 Top Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)"
9479|NCT02714062|O2|Outcome|VI-0521 Mid Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)"
9480|NCT02714062|O1|Outcome|Placebo|Days 1-56: Placebo
9481|NCT02714062|O3|Outcome|VI-0521 Top Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)"
9482|NCT02714062|O2|Outcome|VI-0521 Mid Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)"
9483|NCT02714062|O1|Outcome|Placebo|Days 1-56: Placebo
9484|NCT02714062|O2|Outcome|VI-0521 Top Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)"
9485|NCT02714062|O1|Outcome|VI-0521 Mid Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)"
9486|NCT02714062|O2|Outcome|VI-0521 Top Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)"
9487|NCT02714062|O1|Outcome|VI-0521 Mid Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)"
9488|NCT02714062|O3|Outcome|VI-0521 Top Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)"
17624|NCT02577107|O2|Outcome|Conbercept 0.5 mg|Three monthly injections of 0.5mg Conbercept
9494|NCT02714062|O3|Outcome|VI-0521 Top Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)"
9495|NCT02714062|O2|Outcome|VI-0521 Mid Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)"
9496|NCT02714062|O1|Outcome|Placebo|Days 1-56: Placebo
9497|NCT02714062|O3|Outcome|VI-0521 Top Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)"
9498|NCT02714062|O2|Outcome|VI-0521 Mid Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)"
9499|NCT02714062|O1|Outcome|Placebo|Days 1-56: Placebo
9500|NCT02714062|O3|Outcome|VI-0521 Top Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)"
9501|NCT02714062|O2|Outcome|VI-0521 Mid Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)"
9502|NCT02714062|O1|Outcome|Placebo|Days 1-56: Placebo
9503|NCT02714062|O3|Outcome|VI-0521 Top Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)"
9504|NCT02714062|O2|Outcome|VI-0521 Mid Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)"
9505|NCT02714062|O1|Outcome|Placebo|Days 1-56: Placebo
9506|NCT02714062|O3|Outcome|VI-0521 Top Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)"
9507|NCT02714062|O2|Outcome|VI-0521 Mid Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)"
9508|NCT02714062|O1|Outcome|Placebo|Days 1-56: Placebo
9509|NCT02714062|O2|Outcome|VI-0521 Top Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)"
9510|NCT02714062|O1|Outcome|VI-0521 Mid Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)"
9511|NCT02714062|O2|Outcome|VI-0521 Top Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)"
9512|NCT02714062|O1|Outcome|VI-0521 Mid Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)"
9513|NCT02714062|O2|Outcome|VI-0521 Top Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)"
9514|NCT02714062|O1|Outcome|VI-0521 Mid Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)"
9515|NCT02714062|O2|Outcome|VI-0521 Top Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)"
9516|NCT02714062|O1|Outcome|VI-0521 Mid Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)"
9517|NCT02714062|E3|Reported Event|VI-0521 Top Dose|VI-0521 Top Dose: phentermine 15 mg and topiramate 92 mg, po once daily
9518|NCT02714062|E2|Reported Event|VI-0521 Mid Dose|VI-0521 Mid Dose: phentermine 7.5 mg and topiramate 46 mg, po once daily
9519|NCT02714062|E1|Reported Event|Placebo|Placebo: Placebo, po once daily
9520|NCT02713594|B3|Baseline|Total|Total of all reporting groups
9521|NCT02713594|B2|Baseline|Incentive|Counseling from WTQL; Financial incentive to participate
9522|NCT02713594|B1|Baseline|Control|Counseling from WTQL
9523|NCT02713594|P2|Participant Flow|Incentive|"Participants in the Incentive Condition received counseling from the Wisconsin Tobacco Quit Line (WTQL) consisting of 5 proactive calls to the participant to help them successfully quit tobacco use, plus ad hoc calls at the participant’s initiation; also, WTQL coaches encouraged participants to see their health care provider to obtain Medicaid-approved smoking cessation medications to help them quit smoking.~Participants in the Incentive condition also received financial incentives to complete proactive counseling calls from the WTQL received ($30 per completed call); in addition, Incentive condition participants received $40 for producing biochemical evidence of abstinence at the 6-month follow-up visit."
9524|NCT02713594|P1|Participant Flow|Control|Participants in the Control condition received counseling from the Wisconsin Tobacco Quit Line (WTQL) consisting of 5 proactive calls to the participant to help them successfully quit tobacco use, plus ad hoc calls at the participant’s initiation; also, WTQL coaches encouraged participants to see their health care provider to obtain Medicaid-approved smoking cessation medications to help them quit smoking.
9525|NCT02713594|O2|Outcome|Incentive|"Counseling from WTQL; Financial incentive to participate~Counseling from WTQL: Counseling from the Wisconsin Tobacco Quit Line (WTQL) consisted of 5 proactive calls to the participant to help them successfully quit tobacco use, plus ad hoc calls at the participant’s initiation; also, WTQL coaches encouraged participants to see their health care provider to obtain Medicaid-approved smoking cessation medications to help them quit smoking.~Financial incentive to participate: Participants in the Incentive condition received $30 per call for up to five WTQL calls taken; in addition, Incentive condition participants received $40 for producing biochemical evidence of abstinence at the 6-month follow-up visit. (Note that participants in both the Control condition and the Incentive condition received $40 for completing the baseline biochemical smoking status assessment visit and $40 for completing the 6-month follow-up biochemical smoking status assessment visit.)"
9706|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
9526|NCT02713594|O1|Outcome|Control|"Counseling from WTQL~Counseling from WTQL: Counseling from the Wisconsin Tobacco Quit Line (WTQL) consisted of 5 proactive calls to the participant to help them successfully quit tobacco use, plus ad hoc calls at the participant’s initiation; also, WTQL coaches encouraged participants to see their health care provider to obtain Medicaid-approved smoking cessation medications to help them quit smoking."
9527|NCT02713594|O2|Outcome|Incentive|Counseling from WTQL; Financial incentive to participate
9528|NCT02713594|O1|Outcome|Control|Counseling from WTQL
9529|NCT02713594|O2|Outcome|Incentive|Counseling from WTQL; Financial incentive to participate
9530|NCT02713594|O1|Outcome|Control|Counseling from WTQL
9531|NCT02713594|E2|Reported Event|Incentive|Counseling from WTQL; Financial incentive to participate
9532|NCT02713594|E1|Reported Event|Control|Counseling from WTQL
9533|NCT02713256|B1|Baseline|CFZ533 10 mg/kg|CFZ533 intravenously over approximately one hour
9534|NCT02713256|P1|Participant Flow|CFZ533 10 mg/kg|CFZ533 intravenously over approximately one hour
9535|NCT02713256|O1|Outcome|CFZ533 10 mg/kg|CFZ533 intravenously over approximately one hour
9536|NCT02713256|O1|Outcome|CFZ533 10 mg/kg|CFZ533 intravenously over approximately one hour
9537|NCT02713256|O1|Outcome|CFZ533 10 mg/kg|CFZ533 intravenously over approximately one hour
9538|NCT02713256|E1|Reported Event|CFZ533 10 mg/kg|CFZ533 intravenously over approximately one hour
9539|NCT02712333|B3|Baseline|Total|Total of all reporting groups
9540|NCT02712333|B2|Baseline|Group2-sham Air Purification First, Then Real Air Purification|"Participants in this group received a treatment of sham air purification first, and then switched to the real purification treatment the second stage.~For real air purification, we used high efficient air purifiers (model KJEA200e, 3M), and all participants were required to stay in their dormitory rooms with the windows/doors closed throughout intervention period. For sham air purification, we placed a sham air purifier (with HEPA filters removed) while keeping the rest of the experiment conditions and requirements for the participants unchanged. All participants and research staffs were blinded to the group assignment."
9541|NCT02712333|B1|Baseline|Group1-air Purification First, Then Sham Air Purification|"Participants in this group received a treatment of true air purification first, and then switched to the sham purification treatment the second stage.~For real air purification, we used high efficient air purifiers (model KJEA200e, 3M), and all participants were required to stay in their dormitory rooms with the windows/doors closed throughout intervention period. For sham air purification, we placed a sham air purifier (with HEPA filters removed) while keeping the rest of the experiment conditions and requirements for the participants unchanged. All participants and research staffs were blinded to the group assignment."
9542|NCT02712333|P2|Participant Flow|Group2-sham Air Purification First, Then Real Air Purification|"Participants in this group received an intervention of sham air purifiers, which were under the same conditions as the true purifiers except the filter gauze in them were removed.~Sham Air Purification: This group went through a 9-day intervention with a sham air purifier (with its filter gauze removed) placed in the center of the room. All rooms used the same air purifiers (model KJEA200e, 3M) as the intervention group, except the filter gauze was removed. During the study period all participants were required to stay in their dormitory rooms as much as possible with the windows/doors closed. All participants and research staffs were blinded to the group assignment."
9543|NCT02712333|P1|Participant Flow|Group 1-air Purification First, Then Sham Air Purification|"Participants in this group received an intervention of true air purifiers placed in the center of the room.~Real Air Purification: The 17 dormitory rooms and their residents were randomized into two groups: the intervention and control group. The intervention group went through a 9-day intervention with an air purifier placed in the center of the room. All rooms in this group used the same qualified air purifiers (model KJEA200e, 3M), and all participants were required to stay in their dormitory rooms as much as possible with the windows/doors closed throughout intervention period. All participants and research staffs were blinded to the group assignment."
9544|NCT02712333|O2|Outcome|Sham Air Purification|Participants received a treatment of sham air purification
9545|NCT02712333|O1|Outcome|Real Purification|Participants received a treatment of air purification
9546|NCT02712333|O2|Outcome|Sham Air Purification|Participants received a treatment of sham air purification
9547|NCT02712333|O1|Outcome|Real Purification|Participants received a treatment of air purification
9548|NCT02712333|O2|Outcome|Sham Purification|Participants received a treatment of sham air purification
9549|NCT02712333|O1|Outcome|Real Purification|Participants received a treatment of air purification
9550|NCT02712333|O2|Outcome|Sham Purification|Participants received a treatment of sham air purification
9551|NCT02712333|O1|Outcome|Real Purification|Participants received a treatment of air purification
9552|NCT02712333|O2|Outcome|Sham Air Purification|Participants received a treatment of sham air purification.
9553|NCT02712333|O1|Outcome|Real Purification|Participants received a treatment of real air purification.
9554|NCT02712333|O2|Outcome|Sham Purification|Participants received a treatment of sham air purification
9555|NCT02712333|O1|Outcome|Real Purification|Participants received a treatment of air purification
9556|NCT02712333|O2|Outcome|Sham Purification|Participants received sham air purification first.
9557|NCT02712333|O1|Outcome|Real Purification|Participants in this group received a treatment of air purification.
9558|NCT02712333|E2|Reported Event|Sham Air Purification|"Participants in this group received an intervention of sham air purifiers, which were under the same conditions as the true purifiers except the filter gauze in them were removed.~Sham Air Purification: This group went through a 9-day intervention with a sham air purifier (with its filter gauze removed) placed in the center of the room. All rooms used the same air purifiers (model KJEA200e, 3M) as the intervention group, except the filter gauze was removed. During the study period all participants were required to stay in their dormitory rooms as much as possible with the windows/doors closed. All participants and research staffs were blinded to the group assignment."
9631|NCT02710630|O5|Outcome|Dabigatran Etexilate Tablet: D1|The subjects received Dabigatran Etexilate (Test) tablet formulation (D1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
17625|NCT02577107|O1|Outcome|Ranibizumab 0.5 mg|Three monthly injections of 0.5mg Ranibizumab
9559|NCT02712333|E1|Reported Event|Real Air Purification|"Participants in this group received an intervention of true air purifiers placed in the center of the room.~Real Air Purification: The 17 dormitory rooms and their residents were randomized into two groups: the intervention and control group. The intervention group went through a 9-day intervention with an air purifier placed in the center of the room. All rooms in this group used the same qualified air purifiers (model KJEA200e, 3M), and all participants were required to stay in their dormitory rooms as much as possible with the windows/doors closed throughout intervention period. All participants and research staffs were blinded to the group assignment."
9560|NCT02712099|B3|Baseline|Total|Total of all reporting groups
9561|NCT02712099|B2|Baseline|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~When not separated easily manual removal was done, with uterotonics, together with uterine massage.~20 Women with placenta previa who had difficult placenta delivery"
9562|NCT02712099|B1|Baseline|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~30 Women with placenta previa who had easily placenta delivery"
9563|NCT02712099|P2|Participant Flow|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~When not separated easily manual removal was done, with uterotonics, together with uterine massage.~20 Women with placenta previa who had difficult placenta delivery"
9564|NCT02712099|P1|Participant Flow|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~30 Women with placenta previa who had easily placenta delivery"
9565|NCT02712099|O2|Outcome|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~When not separated easily manual removal was done, with uterotonics, together with uterine massage.~20 Women with placenta previa who had difficult placenta delivery"
9566|NCT02712099|O1|Outcome|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~30 Women with placenta previa who had easily placenta delivery"
9567|NCT02712099|O2|Outcome|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~When not separated easily manual removal was done, with uterotonics, together with uterine massage.~20 Women with placenta previa who had difficult placenta delivery"
9568|NCT02712099|O1|Outcome|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~30 Women with placenta previa who had easily placenta delivery"
20052|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
9569|NCT02712099|O2|Outcome|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~When not separated easily manual removal was done, with uterotonics, together with uterine massage.~20 Women with placenta previa who had difficult placenta delivery"
9570|NCT02712099|O1|Outcome|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~30 Women with placenta previa who had easily placenta delivery"
9571|NCT02712099|O2|Outcome|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~When not separated easily manual removal was done, with uterotonics, together with uterine massage.~20 Women with placenta previa who had difficult placenta delivery"
9572|NCT02712099|O1|Outcome|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~30 Women with placenta previa who had easily placenta delivery"
9573|NCT02712099|O2|Outcome|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~When not separated easily manual removal was done, with uterotonics, together with uterine massage.~20 Women with placenta previa who had difficult placenta delivery"
9574|NCT02712099|O1|Outcome|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~30 Women with placenta previa who had easily placenta delivery"
9575|NCT02712099|O2|Outcome|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~When not separated easily manual removal was done, with uterotonics, together with uterine massage.~20 Women with placenta previa who had difficult placenta delivery"
9576|NCT02712099|O1|Outcome|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~30 Women with placenta previa who had easily placenta delivery"
9577|NCT02712099|E2|Reported Event|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~When not separated easily manual removal was done, with uterotonics, together with uterine massage.~20 Women with placenta previa who had difficult placenta delivery"
9578|NCT02712099|E1|Reported Event|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~30 Women with placenta previa who had easily placenta delivery"
9579|NCT02711995|B1|Baseline|Botulinum Toxin First and RenuGel After|Patients with essential voice tremor underwent botulinum toxin chemodenervation injection. After washout (90 days) , patients underwent injection augmentation. Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril.
9580|NCT02711995|P1|Participant Flow|Botulinum Toxin First and RenuGel After|Patients with essential voice tremor underwent botulinum toxin chemodenervation injection. After washout (90 days) , patients underwent injection augmentation. Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril.
9581|NCT02711995|O2|Outcome|RenuGel|"Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.~RenuGel: Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders."
9582|NCT02711995|O1|Outcome|Botulinum Toxin|"Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.~Botulinum Toxin: Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder."
9583|NCT02711995|O2|Outcome|RenuGel|"Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.~RenuGel: Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders."
9584|NCT02711995|O1|Outcome|Botulinum Toxin|"Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.~Botulinum Toxin: Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder."
9585|NCT02711995|O2|Outcome|RenuGel|"Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.~RenuGel: Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders."
9586|NCT02711995|O1|Outcome|Botulinum Toxin|"Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.~Botulinum Toxin: Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder."
9587|NCT02711995|O2|Outcome|RenuGel|"Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.~RenuGel: Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders."
9588|NCT02711995|O1|Outcome|Botulinum Toxin|"Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.~Botulinum Toxin: Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder."
9632|NCT02710630|O4|Outcome|Dabigatran Etexilate Tablet: C1|The subjects received Dabigatran Etexilate (Test) tablet formulation (C1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
17626|NCT02577107|E2|Reported Event|Conbercept 0.5 mg|Three monthly injections of 0.5mg Conbercept
9589|NCT02711995|O2|Outcome|RenuGel|"Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.~RenuGel: Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders."
9590|NCT02711995|O1|Outcome|Botulinum Toxin|"Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.~Botulinum Toxin: Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder."
9591|NCT02711995|O2|Outcome|RenuGel|"Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.~RenuGel: Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders."
9592|NCT02711995|O1|Outcome|Botulinum Toxin|"Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.~Botulinum Toxin: Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder."
9593|NCT02711995|O2|Outcome|RenuGel|"Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.~RenuGel: Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders."
9594|NCT02711995|O1|Outcome|Botulinum Toxin|"Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.~Botulinum Toxin: Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder."
9595|NCT02711995|O2|Outcome|RenuGel|"Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.~RenuGel: Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders."
9596|NCT02711995|O1|Outcome|Botulinum Toxin|"Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.~Botulinum Toxin: Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder."
9597|NCT02711995|O2|Outcome|RenuGel|"Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.~RenuGel: Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders."
9598|NCT02711995|O1|Outcome|Botulinum Toxin|"Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.~Botulinum Toxin: Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder."
9633|NCT02710630|O3|Outcome|Dabigatran Etexilate Tablet: B1|The subjects received Dabigatran Etexilate (Test) tablet formulation (B1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9634|NCT02710630|O2|Outcome|Dabigatran Etexilate Tablet: A1|The subjects received Dabigatran Etexilate (Test) tablet formulation (A1), 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9707|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
9599|NCT02711995|E2|Reported Event|RenuGel|"Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.~RenuGel: Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders."
9600|NCT02711995|E1|Reported Event|Botulinum Toxin|"Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.~Botulinum Toxin: Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder."
9601|NCT02710630|B6|Baseline|Total|Total of all reporting groups
9602|NCT02710630|B5|Baseline|Ref-E1-A1-B1-C1-D1|"All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation E1 (TF-E1) in period 2, followed by Test Formulation A1 (TF-A1) in period 3, followed by Test Formulation B1 (TF-B1) in period 4, followed by Test Formulation C1 (TF-C1) in period 5, followed by Test Formulation D1 (TF-D1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.~A washout period of at least 4 days was set following the drug administration in each period."
9603|NCT02710630|B4|Baseline|Ref-D1-E1-A1-B1-C1|"All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation D1 (TF-D1) in period 2, followed by Test Formulation E1 (TF-E1) in period 3, followed by Test Formulation A1 (TF-A1) in period 4, followed by Test Formulation B1 (TF-B1) in period 5, followed by Test Formulation C1 (TF-C1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.~A washout period of at least 4 days was set following the drug administration in each period."
9604|NCT02710630|B3|Baseline|Ref-C1-D1-E1-A1-B1|"All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation C1 (TF-C1) in period 2, followed by Test Formulation D1 (TF-D1) in period 3, followed by Test Formulation E1 (TF-E1) in period 4, followed by Test Formulation A1 (TF-A1) in period 5, followed by Test Formulation B1 (TF-B1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.~A washout period of at least 4 days was set following the drug administration in each period."
9605|NCT02710630|B2|Baseline|Ref-B1-C1-D1-E1-A1|"All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation B1 (TF-B1) in period 2, followed by Test Formulation C1 (TF-C1) in period 3, followed by Test Formulation D1 (TF-D1) in period 4, followed by Test Formulation E1 (TF-E1) in period 5, followed by Test Formulation A1 (TF-A1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.~A washout period of at least 4 days was set following the drug administration in each period."
9606|NCT02710630|B1|Baseline|Ref-A1-B1-C1-D1-E1|"All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation A1 (TF-A1) in period 2, followed by Test Formulation B1 (TF-B1) in period 3, followed by Test Formulation C1 (TF-C1) in period 4, followed by Test Formulation D1 (TF-D1) in period 5, followed by Test Formulation E1 (TF-E1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.~A washout period of at least 4 days was set following the drug administration in each period."
9607|NCT02710630|P5|Participant Flow|Ref-E1-A1-B1-C1-D1|"All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation E1 (TF-E1) in period 2, followed by Test Formulation A1 (TF-A1) in period 3, followed by Test Formulation B1 (TF-B1) in period 4, followed by Test Formulation C1 (TF-C1) in period 5, followed by Test Formulation D1 (TF-D1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.~A washout period of at least 4 days was set following the drug administration in each period."
9608|NCT02710630|P4|Participant Flow|Ref-D1-E1-A1-B1-C1|"All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation D1 (TF-D1) in period 2, followed by Test Formulation E1 (TF-E1) in period 3, followed by Test Formulation A1 (TF-A1) in period 4, followed by Test Formulation B1 (TF-B1) in period 5, followed by Test Formulation C1 (TF-C1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.~A washout period of at least 4 days was set following the drug administration in each period."
9609|NCT02710630|P3|Participant Flow|Ref-C1-D1-E1-A1-B1|"All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation C1 (TF-C1) in period 2, followed by Test Formulation D1 (TF-D1) in period 3, followed by Test Formulation E1 (TF-E1) in period 4, followed by Test Formulation A1 (TF-A1) in period 5, followed by Test Formulation B1 (TF-B1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.~A washout period of at least 4 days was set following the drug administration in each period."
9610|NCT02710630|P2|Participant Flow|Ref-B1-C1-D1-E1-A1|"All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation B1 (TF-B1) in period 2, followed by Test Formulation C1 (TF-C1) in period 3, followed by Test Formulation D1 (TF-D1) in period 4, followed by Test Formulation E1 (TF-E1) in period 5, followed by Test Formulation A1 (TF-A1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.~A washout period of at least 4 days was set following the drug administration in each period."
9611|NCT02710630|P1|Participant Flow|Ref-A1-B1-C1-D1-E1|"All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation A1 (TF-A1) in period 2, followed by Test Formulation B1 (TF-B1) in period 3, followed by Test Formulation C1 (TF-C1) in period 4, followed by Test Formulation D1 (TF-D1) in period 5, followed by Test Formulation E1 (TF-E1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.~A washout period of at least 4 days was set following the drug administration in each period."
9612|NCT02710630|O6|Outcome|Dabigatran Etexilate Tablet: E1|The subjects received Dabigatran Etexilate (Test) tablet formulation (E1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9613|NCT02710630|O5|Outcome|Dabigatran Etexilate Tablet: D1|The subjects received Dabigatran Etexilate (Test) tablet formulation (D1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9614|NCT02710630|O4|Outcome|Dabigatran Etexilate Tablet: C1|The subjects received Dabigatran Etexilate (Test) tablet formulation (C1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9615|NCT02710630|O3|Outcome|Dabigatran Etexilate Tablet: B1|The subjects received Dabigatran Etexilate (Test) tablet formulation (B1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9616|NCT02710630|O2|Outcome|Dabigatran Etexilate Tablet: A1|The subjects received Dabigatran Etexilate (Test) tablet formulation (A1), 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9617|NCT02710630|O1|Outcome|Dabigatran Etexilate Capsule: Ref|The subjects received Dabigatran Etexilate (Reference) capsule formulation (commercial formulation) 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9618|NCT02710630|O6|Outcome|Dabigatran Etexilate Tablet: E1|The subjects received Dabigatran Etexilate (Test) tablet formulation (E1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9619|NCT02710630|O5|Outcome|Dabigatran Etexilate Tablet: D1|The subjects received Dabigatran Etexilate (Test) tablet formulation (D1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9620|NCT02710630|O4|Outcome|Dabigatran Etexilate Tablet: C1|The subjects received Dabigatran Etexilate (Test) tablet formulation (C1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9621|NCT02710630|O3|Outcome|Dabigatran Etexilate Tablet: B1|The subjects received Dabigatran Etexilate (Test) tablet formulation (B1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9622|NCT02710630|O2|Outcome|Dabigatran Etexilate Tablet: A1|The subjects received Dabigatran Etexilate (Test) tablet formulation (A1), 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9623|NCT02710630|O1|Outcome|Dabigatran Etexilate Capsule: Ref|The subjects received Dabigatran Etexilate (Reference) capsule formulation (commercial formulation) 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9624|NCT02710630|O6|Outcome|Dabigatran Etexilate Tablet: E1|The subjects received Dabigatran Etexilate (Test) tablet formulation (E1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9625|NCT02710630|O5|Outcome|Dabigatran Etexilate Tablet: D1|The subjects received Dabigatran Etexilate (Test) tablet formulation (D1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9626|NCT02710630|O4|Outcome|Dabigatran Etexilate Tablet: C1|The subjects received Dabigatran Etexilate (Test) tablet formulation (C1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9627|NCT02710630|O3|Outcome|Dabigatran Etexilate Tablet: B1|The subjects received Dabigatran Etexilate (Test) tablet formulation (B1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9628|NCT02710630|O2|Outcome|Dabigatran Etexilate Tablet: A1|The subjects received Dabigatran Etexilate (Test) tablet formulation (A1), 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9629|NCT02710630|O1|Outcome|Dabigatran Etexilate Capsule: Ref|The subjects received Dabigatran Etexilate (Reference) capsule formulation (commercial formulation) 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9630|NCT02710630|O6|Outcome|Dabigatran Etexilate Tablet: E1|The subjects received Dabigatran Etexilate (Test) tablet formulation (E1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9635|NCT02710630|O1|Outcome|Dabigatran Etexilate Capsule: Ref|The subjects received Dabigatran Etexilate (Reference) capsule formulation (commercial formulation) 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9636|NCT02710630|O6|Outcome|Dabigatran Etexilate Tablet: E1|The subjects received Dabigatran Etexilate (Test) tablet formulation (E1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9637|NCT02710630|O5|Outcome|Dabigatran Etexilate Tablet: D1|The subjects received Dabigatran Etexilate (Test) tablet formulation (D1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9638|NCT02710630|O4|Outcome|Dabigatran Etexilate Tablet: C1|The subjects received Dabigatran Etexilate (Test) tablet formulation (C1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9639|NCT02710630|O3|Outcome|Dabigatran Etexilate Tablet: B1|The subjects received Dabigatran Etexilate (Test) tablet formulation (B1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9640|NCT02710630|O2|Outcome|Dabigatran Etexilate Tablet: A1|The subjects received Dabigatran Etexilate (Test) tablet formulation (A1), 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9641|NCT02710630|O1|Outcome|Dabigatran Etexilate Capsule: Ref|The subjects received Dabigatran Etexilate (Reference) capsule formulation (commercial formulation) 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9642|NCT02710630|O6|Outcome|Dabigatran Etexilate Tablet: E1|The subjects received Dabigatran Etexilate (Test) tablet formulation (E1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9643|NCT02710630|O5|Outcome|Dabigatran Etexilate Tablet: D1|The subjects received Dabigatran Etexilate (Test) tablet formulation (D1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9644|NCT02710630|O4|Outcome|Dabigatran Etexilate Tablet: C1|The subjects received Dabigatran Etexilate (Test) tablet formulation (C1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9645|NCT02710630|O3|Outcome|Dabigatran Etexilate Tablet: B1|The subjects received Dabigatran Etexilate (Test) tablet formulation (B1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9646|NCT02710630|O2|Outcome|Dabigatran Etexilate Tablet: A1|The subjects received Dabigatran Etexilate (Test) tablet formulation (A1), 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9647|NCT02710630|O1|Outcome|Dabigatran Etexilate Capsule: Ref|The subjects received Dabigatran Etexilate (Reference) capsule formulation (commercial formulation) 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9648|NCT02710630|E6|Reported Event|Dabigatran Etexilate Tablet: E1|The subjects received Dabigatran Etexilate (Test) tablet formulation (E1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9649|NCT02710630|E5|Reported Event|Dabigatran Etexilate Tablet: D1|The subjects received Dabigatran Etexilate (Test) tablet formulation (D1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9650|NCT02710630|E4|Reported Event|Dabigatran Etexilate Tablet: C1|The subjects received Dabigatran Etexilate (Test) tablet formulation (C1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9651|NCT02710630|E3|Reported Event|Dabigatran Etexilate Tablet: B1|The subjects received Dabigatran Etexilate (Test) tablet formulation (B1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9652|NCT02710630|E2|Reported Event|Dabigatran Etexilate Tablet: A1|The subjects received Dabigatran Etexilate (Test) tablet formulation (A1), 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9653|NCT02710630|E1|Reported Event|Dabigatran Etexilate Capsule: Ref|The subjects received Dabigatran Etexilate (Reference) capsule formulation (commercial formulation) 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
9654|NCT02710292|B1|Baseline|Overall|Delefilcon A and narafilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment.
9655|NCT02710292|P2|Participant Flow|TE, Then DT1|Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.
9656|NCT02710292|P1|Participant Flow|DT1, Then TE|Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.
9657|NCT02710292|O2|Outcome|TruEye|Narafilcon A contact lenses worn bilaterally during Period 1 or Period 2 for at least 7 days in a daily disposable modality.
9658|NCT02710292|O1|Outcome|Dailies Total1|Delefilcon A contact lenses worn bilaterally during Period 1 or Period 2 for for at least 7 days in a daily disposable modality.
9659|NCT02710292|E3|Reported Event|TruEye|All subjects exposed to narafilcon A contact lenses
9660|NCT02710292|E2|Reported Event|Dailies Total1|All subjects exposed to delefilcon A contact lenses
9661|NCT02710292|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to initiation of study treatment
9662|NCT02709577|B3|Baseline|Total|Total of all reporting groups
9663|NCT02709577|B2|Baseline|Sham: Endoscopy and Standard of Care|"Subjects randomized to sham arm received an upper GI examination and were evaluated for study endpoints.~Sham: endoscopy and standard of care: Sham subjects had an endoscopic procedure and then received standard of care treatment of their diabetes"
9664|NCT02709577|B1|Baseline|EndoBarrier Gastrointestinal Liner|"Subjects randomized and implanted with the EndoBarrier Gastrointestinal liner; subjects will be implanted for 24 weeks to 52 weeks and evaluated for study endpoints.~EndoBarrier Gastrointestinal Liner: The EndoBarrier is a single use, implant consisting of a tube of composite material which is placed in the proximal section of the duodenum. The implant is fixed in place with the aid of a metal anchor. The device is delivered via an endoscope. The implant facilitates the passage of food from the stomach through the tube to the proximal section of the jejunum."
9665|NCT02709577|P4|Participant Flow|Cohort B Control Sham|Device not implanted.
9667|NCT02709577|P2|Participant Flow|Cohort B:EndoBarrier Gastrointestinal Liner|Subjects in Cohort B had a 52 week implant period. Follow-up after device removal was originally 6 months and then extended to 12 months based on physician discretion.
9668|NCT02709577|P1|Participant Flow|Cohort A: EndoBarrier Gastrointestinal Liner|Subjects in Cohort A were implanted with the device for 24 weeks and given the option to continue for up to 52 weeks.
9669|NCT02709577|O4|Outcome|Cohort B Control Sham: Endoscopy and Standard of Care|Subjects received only an upper GI endoscopic examination with no device implantation. Follow-up after treatment phase was 12 months.
9670|NCT02709577|O3|Outcome|Cohort A Control Sham: Endoscopy and Standard of Care|Subjects received only an upper GI endoscopic examination with no device implantation. Follow-up after treatment phase was originally 6 months and then extended to 12 months based on physician discretion.
9671|NCT02709577|O2|Outcome|Cohort B: EndoBarrier Gastrointestinal Liner|Subjects in Cohort B had a 52 week implant period. Follow-up after device removal was originally 6 months and then extended to 12 months based on physician discretion.
9672|NCT02709577|O1|Outcome|Cohoart A: EndoBarrier Gastrointestinal Liner|Subjects in Cohort A were implanted with the device for 24 weeks and given the option to continue for up to 52 weeks.
9673|NCT02709577|O4|Outcome|Cohort B Control Sham: Endoscopy and Standard of Care|Subjects received only an upper GI endoscopic examination with no device implantation.
9674|NCT02709577|O3|Outcome|Cohort A Control Sham: Endoscopy and Standard of Care|Subjects received only an upper GI endoscopic examination with no device implantation.
9675|NCT02709577|O2|Outcome|Cohort B: EndoBarrier Gastrointestinal Liner|Subjects in Cohort B had a 52 week implant period. Follow-up after device removal was originally 6 months and then extended to 12 months based on physician discretion.
9676|NCT02709577|O1|Outcome|Cohort A: EndoBarrier Gastrointestinal Liner|Subjects in Cohort A were implanted with the device for 24 weeks and given the option to continue for up to 52 weeks.
9677|NCT02709577|E2|Reported Event|Cohorts A and B Sham: Endoscopy and Standard of Care|Subjects randomized to sham and underwent an endoscopy procedure and then received standard of care treatment for their diabetes
9678|NCT02709577|E1|Reported Event|Cohorts A and B: EndoBarrier Gastrointestinal Liner|Subjects randomized and implanted with the EndoBarrier Gastrointestinal liner; subjects will be implanted for 24 or 52 weeks and evaluated for study endpoints
9679|NCT02709096|B3|Baseline|Total|Total of all reporting groups
9680|NCT02709096|B2|Baseline|BPX-01, Vehicle Gel|"BPX-01, Vehicle Gel; applied once daily to the face for four weeks.~BPX-01 Vehicle Gel: topical gel, applied to the forehead, cheeks, nose and chin"
9681|NCT02709096|B1|Baseline|BPX-01, 1% Topical Gel|"BPX-01, 1% Topical Gel; applied once daily to the face for four weeks.~BPX-01, 1% Topical Gel: topical gel, applied to the forehead, cheeks, nose and chin"
9682|NCT02709096|P2|Participant Flow|BPX-01, Vehicle Gel|"BPX-01, Vehicle Gel; applied once daily to the face for four weeks.~BPX-01 Vehicle Gel: topical gel, applied to the forehead, cheeks, nose and chin"
9683|NCT02709096|P1|Participant Flow|BPX-01, 1% Topical Gel|"BPX-01, 1% Topical Gel; applied once daily to the face for four weeks.~BPX-01, 1% Topical Gel: topical gel, applied to the forehead, cheeks, nose and chin"
9684|NCT02709096|O2|Outcome|BPX-01, Vehicle Gel|"BPX-01, Vehicle Gel; applied once daily to the face for four weeks.~BPX-01 Vehicle Gel: topical gel, applied to the forehead, cheeks, nose and chin"
9685|NCT02709096|O1|Outcome|BPX-01, 1% Topical Gel|"BPX-01, 1% Topical Gel; applied once daily to the face for four weeks.~BPX-01, 1% Topical Gel: topical gel, applied to the forehead, cheeks, nose and chin"
9686|NCT02709096|E2|Reported Event|BPX-01, Vehicle Gel|"BPX-01, Vehicle Gel; applied once daily to the face for four weeks.~BPX-01 Vehicle Gel: topical gel, applied to the forehead, cheeks, nose and chin"
9687|NCT02709096|E1|Reported Event|BPX-01, 1% Topical Gel|"BPX-01, 1% Topical Gel; applied once daily to the face for four weeks.~BPX-01, 1% Topical Gel: topical gel, applied to the forehead, cheeks, nose and chin"
9688|NCT02708524|B5|Baseline|Total|Total of all reporting groups
9689|NCT02708524|B4|Baseline|Samfilcon A|All subjects that wore the samfilcon A lens throughout the duration of the study.
9690|NCT02708524|B3|Baseline|Lotrafilcon B|All subjects that wore the lotrafilcon B lens throughout the duration of the study.
9691|NCT02708524|B2|Baseline|Comfilcon A|All subjects that wore the comfilcon A lens throughout the duration of the study.
9692|NCT02708524|B1|Baseline|Senofilcon C|All subjects that wore the senofilcon C lens throughout the duration of the study.
9693|NCT02708524|P4|Participant Flow|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
9694|NCT02708524|P3|Participant Flow|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
9695|NCT02708524|P2|Participant Flow|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
9696|NCT02708524|P1|Participant Flow|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
9697|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
9698|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
9699|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
9700|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
9701|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
9702|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
9703|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
9704|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
9705|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
9793|NCT02708212|O2|Outcome|Colonoscopy-EGD Group|The duration of both colonoscopy and EGD examinations was recorded and compared.
9708|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
9709|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
9710|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
9711|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
9712|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
9713|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
9714|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
9715|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
9716|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
9717|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
9718|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
9719|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
9720|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
9721|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
9722|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
9723|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
9724|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
9725|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
9726|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
9727|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
9728|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
9729|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
9730|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
9731|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
9732|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
9733|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
9734|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
9735|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
9736|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
9737|NCT02708524|E4|Reported Event|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
9738|NCT02708524|E3|Reported Event|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
9739|NCT02708524|E2|Reported Event|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
9740|NCT02708524|E1|Reported Event|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
9741|NCT02708355|B4|Baseline|Total|Total of all reporting groups
9742|NCT02708355|B3|Baseline|Placebo|Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14.
9743|NCT02708355|B2|Baseline|Esomeprazole 20 mg Once Daily + Placebo|Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14.
9744|NCT02708355|B1|Baseline|Esomeprazole 20 mg Twice Daily|Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14.
9745|NCT02708355|P3|Participant Flow|Placebo|Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14.
9746|NCT02708355|P2|Participant Flow|Esomeprazole 20 mg Once Daily + Placebo|Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14.
9747|NCT02708355|P1|Participant Flow|Esomeprazole 20 mg Twice Daily|Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14.
9748|NCT02708355|O3|Outcome|Placebo|Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14.
9749|NCT02708355|O2|Outcome|Esomeprazole 20 mg Once Daily + Placebo|Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14.
9750|NCT02708355|O1|Outcome|Esomeprazole 20 mg Twice Daily|Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14.
9751|NCT02708355|O3|Outcome|Placebo|Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14.
9752|NCT02708355|O2|Outcome|Esomeprazole 20 mg Once Daily + Placebo|Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14.
9794|NCT02708212|O1|Outcome|EGD-colonoscopy Group|The duration of both EGD and colonoscopy examinations was recorded and compared.
9753|NCT02708355|O1|Outcome|Esomeprazole 20 mg Twice Daily|Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14.
9754|NCT02708355|E3|Reported Event|Placebo|Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14.
9755|NCT02708355|E2|Reported Event|Esomeprazole 20 mg Once Daily + Placebo|Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14.
9756|NCT02708355|E1|Reported Event|Esomeprazole 20 mg Twice Daily|Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14.
9757|NCT02708277|B3|Baseline|Total|Total of all reporting groups
9758|NCT02708277|B2|Baseline|Group B|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.~intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
9759|NCT02708277|B1|Baseline|Group A|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.~loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
9760|NCT02708277|P2|Participant Flow|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.~intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
9761|NCT02708277|P1|Participant Flow|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.~loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
9762|NCT02708277|O2|Outcome|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.~intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
9763|NCT02708277|O1|Outcome|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.~loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
9764|NCT02708277|O2|Outcome|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.~intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
9765|NCT02708277|O1|Outcome|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.~loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
9766|NCT02708277|O2|Outcome|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.~intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
9767|NCT02708277|O1|Outcome|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.~loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
9768|NCT02708277|O2|Outcome|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.~intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
9769|NCT02708277|O1|Outcome|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.~loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
9770|NCT02708277|E2|Reported Event|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.~intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
9771|NCT02708277|E1|Reported Event|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.~loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
9772|NCT02708238|B4|Baseline|Total|Total of all reporting groups
9773|NCT02708238|B3|Baseline|Group C|"All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution~Simethicone"
9774|NCT02708238|B2|Baseline|Group B|"All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension~Lactobacillus reuteri DSM 17938 (108 CFU)"
9775|NCT02708238|B1|Baseline|Group A|"All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution~Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)"
9776|NCT02708238|P3|Participant Flow|Group C|"All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution~Simethicone"
9777|NCT02708238|P2|Participant Flow|Group B|"All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension~Lactobacillus reuteri DSM 17938 (108 CFU)"
9778|NCT02708238|P1|Participant Flow|Group A|"All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution~Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)"
9779|NCT02708238|O3|Outcome|Group C|"All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution~Simethicone"
9780|NCT02708238|O2|Outcome|Group B|"All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension~Lactobacillus reuteri DSM 17938 (108 CFU)"
9781|NCT02708238|O1|Outcome|Group A|"All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution~Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)"
9782|NCT02708238|O3|Outcome|Group C|"All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution~Simethicone"
9783|NCT02708238|O2|Outcome|Group B|"All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension~Lactobacillus reuteri DSM 17938 (108 CFU)"
9784|NCT02708238|O1|Outcome|Group A|"All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution~Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)"
9785|NCT02708238|E3|Reported Event|Group C|"All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution~Simethicone"
9786|NCT02708238|E2|Reported Event|Group B|"All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension~Lactobacillus reuteri DSM 17938 (108 CFU)"
9787|NCT02708238|E1|Reported Event|Group A|"All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution~Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)"
9788|NCT02708212|B3|Baseline|Total|Total of all reporting groups
9789|NCT02708212|B2|Baseline|Colonoscopy-EGD Group|In this study group, 60 patients received a colonoscopy followed by and an EGD during a same-day bidirectional endoscopy. Patients received moderate conscious sedation with fentanyl and midazolam and carbon dioxide insufflation. Interventions with cold forceps polypectomy, cold snare polypectomy or hot snare polypectomy were performed for gastric and/or colon polyps during EGD and colonoscopy examinations. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded every 60 seconds during endoscopic examinations. Patients' tolerability to both endoscopy examinations was scaled by patients and endoscopists after examinations. Aldrete scores, at 15 minutes and 25 minutes after entering the recovery room, were recorded. Recovery time to discharge was also recorded.
9790|NCT02708212|B1|Baseline|EGD-colonoscopy Group|In this study group, 60 patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Patients received moderate conscious sedation with fentanyl and midazolam and carbon dioxide insufflation. Interventions with cold forceps polypectomy, cold snare polypectomy or hot snare polypectomy were performed for gastric and/or colon polyps during endoscopy procedures. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded every 60 seconds during endoscopic examinations. Patients' tolerability to both endoscopy examinations was scaled by patients and endoscopists after examinations. Aldrete scores, at 15 minutes and 25 minutes after entering the recovery room, was recorded. Recovery time to discharge was also recorded.
9791|NCT02708212|P2|Participant Flow|Colonoscopy-EGD Group|In this study group, 60 patients received a colonoscopy followed by and an EGD during a same-day bidirectional endoscopy. Patients received modeate conscious sedation with fentanyl and midazolam and carbon dioxide insufflation. Interventions with cold forceps polypectomy, cold snare polypectomy or hot snare polypectomy were performed for gastric and/or colon polyps during EGD and colonoscopy examinations. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded every 60 seconds during endoscopic examinations. Patients' tolerability to both endoscopy examinations was scaled by patients and endoscopists after examinations. Aldrete scores, at 15 minutes and 25 minutes after entering the recovery room, were recorded. Recovery time to discharge was also recorded.
9792|NCT02708212|P1|Participant Flow|EGD-colonoscopy Group|In this study group, 60 patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Patients received modeate conscious sedation with fentanyl and midazolam and carbon dioxide insullfation. Interventions with cold forceps polypectomy, cold snare polypectomy or hot snare polypectomy were performed for gastric and/or colon polyps during endoscopy procedures. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded every 60 seconds during endoscopic examinations. Patients' tolerability to both endoscopy examinations was scaled by patients and endoscopists after examinations. Aldrete scores, at 15 minutes and 25 minutes after entering the recovery room, was recorded. Recovery time to discharge was also recorded.
17627|NCT02577107|E1|Reported Event|Ranibizumab 0.5 mg|Three monthly injections of 0.5mg Ranibizumab
9795|NCT02708212|O2|Outcome|Colonoscopy-EGD Group|"In this group, patients received a colonoscopy followed by an EGD during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of midazolam after the completion of the bidirectional endoscopy were recorded.~EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study."
9796|NCT02708212|O1|Outcome|EGD-colonoscopy Group|"In this group, patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of midazolam after the completion of the bidirectional endoscopy were recorded.~EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study."
9797|NCT02708212|O2|Outcome|Colonoscopy-EGD Group|"In this group, patients received a colonoscopy followed by an EGD during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of fentanyl after the completion of bidirectional endoscopy were recorded.~EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study."
9798|NCT02708212|O1|Outcome|EGD-colonoscopy Group|"In this group, patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of fentanyl after the completion of bidirectional endoscopy were recorded.~EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study."
9799|NCT02708212|E2|Reported Event|Colonoscopy-EGD Group|Patients received moderate conscious sedation with fentanyl and midazolam. Blood pressure, heart rate, and oxygen saturation were monitored and recorded during the endoscopic procedures. Supplemental oxygen (2 L/min) by nasal cannula was provided for every patient. The following adverse events were recorded during conscious sedation: 1) oxygen desaturation: < 90% persisting for more than 60 s; 2) hypotension: < 90 mm Hg systolic blood pressure for more than 60 s; 3) hypertension: > 180 mm Hg systolic blood pressure for more than 60 s; 4) tachycardia: > 120 beats per minute, lasting more than 60 s; and 5) bradycardia: < 50 beats per minute, lasting more than 60 s.
9800|NCT02708212|E1|Reported Event|EGD-colonoscopy Group|Patients received moderate conscious sedation with fentanyl and midazolam. Blood pressure, heart rate, and oxygen saturation were monitored and recorded during the endoscopic procedures. Supplemental oxygen (2 L/min) by nasal cannula was provided for every patient. The following adverse events were recorded during conscious sedation: 1) oxygen desaturation: < 90% persisting for more than 60 s; 2) hypotension: < 90 mm Hg systolic blood pressure for more than 60 s; 3) hypertension: > 180 mm Hg systolic blood pressure for more than 60 s; 4) tachycardia: > 120 beats per minute, lasting more than 60 s; and 5) bradycardia: < 50 beats per minute, lasting more than 60 s.
9801|NCT02707640|B3|Baseline|Total|Total of all reporting groups
9802|NCT02707640|B2|Baseline|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
9803|NCT02707640|B1|Baseline|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
9804|NCT02707640|P2|Participant Flow|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
9805|NCT02707640|P1|Participant Flow|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
9806|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
9807|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
9808|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
9809|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
9810|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
9811|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
9812|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
9813|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
9814|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
9815|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
9816|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
9817|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
9818|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
9819|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
9820|NCT02707640|E2|Reported Event|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
9821|NCT02707640|E1|Reported Event|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
9822|NCT02707172|B1|Baseline|All Participants|"A total of 28 participants were recruited and were divided into two groups, one group receiving placebo first and then intervention, the other group receiving intervention first and then placebo.~The placebo is handwashing with water using the 6-step standardized handwashing technique.~The intervention is handwasahing with soap using the 6-step standardized handwashing technique."
9823|NCT02707172|P1|Participant Flow|All Participants|"All participants underwent two experiments, one with placebo (handwashing with water) and one with intervention (handwashing with soap), but in different order.~28 participants underwent placebo first and crossed-over to received intervention; while the other 28 participants underwent intervention first and then placebo. There was one day wash-out period between the two sets of experiment.~In each set of the experiment, each participant was exposed to 1000 microgram of diethylhexyl phthalate on both hands, and was asked to perform the placebo or intervention by a standardized hand washing technique depending on the sequence assignment.~A total of 56 placebo experiments were performed and a total of 56 intervention experiments were performed in the study."
9824|NCT02707172|O1|Outcome|All Participants|"A total of 28 participants were recruited and were divided into two groups, one group receiving placebo first and then intervention, the other group receiving intervention first and then placebo.~The placebo is handwashing with water using the 6-step standardized handwashing technique.~The intervention is handwasahing with soap using the 6-step standardized handwashing technique."
9825|NCT02707172|E2|Reported Event|Placebo|"Subject was exposed to 1000 microgram of diethylhexyl phthalate on both hands, and was asked to perform the placebo, handwashing with water, by a standardized hand washing technique.~Then the subjects in this arms are crossover to perform the intervention, handwashing with soap.~handwashing with soap: handwashing with soap by a standardized 6-step handwashing technique~handwashing with water: handwashing with water by a standardized 6-step handwashing technique"
9826|NCT02707172|E1|Reported Event|Intervention|"Subject was first exposed to 1000 microgram of diethylhexyl phthalate on both hands, and was asked to perform the intervention, handwashing with soap, by a standardized hand washing technique.~Then the subjects in this arms are crossover to receive placebo, handwashing with water only.~handwashing with soap: handwashing with soap by a standardized 6-step handwashing technique~handwashing with water: handwashing with water by a standardized 6-step handwashing technique"
9827|NCT02706327|B4|Baseline|Total|Total of all reporting groups
9828|NCT02706327|B3|Baseline|Control|"8-week follow-up with placebo insole and home based exercise program~Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole."
9858|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9829|NCT02706327|B2|Baseline|Semi-custom|"8-week follow-up with semi-custom insole and home based exercise program~Semi-custom Insole: Plantar surfaces of each patient’s metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
9830|NCT02706327|B1|Baseline|CAD/CAM|"8-week follow-up with CAD/CAM insole and home based exercise program~CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
9831|NCT02706327|P3|Participant Flow|Control|"8-week follow-up with placebo insole and home based exercise program~Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole."
9832|NCT02706327|P2|Participant Flow|Semi-custom|"8-week follow-up with semi-custom insole and home based exercise program~Semi-custom Insole: Plantar surfaces of each patient’s metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
9833|NCT02706327|P1|Participant Flow|CAD/CAM|"8-week follow-up with computer-aided design/computer aided manufacturing (CAD/CAM) insole and home based exercise program~CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
9834|NCT02706327|O3|Outcome|Control|"8-week follow-up with placebo insole and home based exercise program~Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole."
9835|NCT02706327|O2|Outcome|Semi-custom|"8-week follow-up with semi-custom insole and home based exercise program~Semi-custom Insole: Plantar surfaces of each patient’s metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
9836|NCT02706327|O1|Outcome|CAD/CAM|"8-week follow-up with CAD/CAM insole and home based exercise program~CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
9837|NCT02706327|O3|Outcome|Control|"8-week follow-up with placebo insole and home based exercise program~Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole."
9838|NCT02706327|O2|Outcome|Semi-custom|"8-week follow-up with semi-custom insole and home based exercise program~Semi-custom Insole: Plantar surfaces of each patient’s metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
9839|NCT02706327|O1|Outcome|CAD/CAM|"8-week follow-up with CAD/CAM insole and home based exercise program~CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
9840|NCT02706327|O3|Outcome|Control|"8-week follow-up with placebo insole and home based exercise program~Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole."
9841|NCT02706327|O2|Outcome|Semi-custom|"8-week follow-up with semi-custom insole and home based exercise program~Semi-custom Insole: Plantar surfaces of each patient’s metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
9842|NCT02706327|O1|Outcome|CAD/CAM|"8-week follow-up with CAD/CAM insole and home based exercise program~CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
9843|NCT02706327|O3|Outcome|Control|"8-week follow-up with placebo insole and home based exercise program~Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole."
9859|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9844|NCT02706327|O2|Outcome|Semi-custom|"8-week follow-up with semi-custom insole and home based exercise program~Semi-custom Insole: Plantar surfaces of each patient’s metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
9845|NCT02706327|O1|Outcome|CAD/CAM|"8-week follow-up with CAD/CAM insole and home based exercise program~CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
9846|NCT02706327|O3|Outcome|Control|"8-week follow-up with placebo insole and home based exercise program~Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole."
9847|NCT02706327|O2|Outcome|Semi-custom|"8-week follow-up with semi-custom insole and home based exercise program~Semi-custom Insole: Plantar surfaces of each patient’s metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
9848|NCT02706327|O1|Outcome|CAD/CAM|"8-week follow-up with CAD/CAM insole and home based exercise program~CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
9849|NCT02706327|E3|Reported Event|Control|"8-week follow-up with placebo insole and home based exercise program~Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole."
9850|NCT02706327|E2|Reported Event|Semi-custom|"8-week follow-up with semi-custom insole and home based exercise program~Semi-custom Insole: Plantar surfaces of each patient’s metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
9851|NCT02706327|E1|Reported Event|CAD/CAM|"8-week follow-up with CAD/CAM insole and home based exercise program~CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
9852|NCT02705807|B1|Baseline|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9853|NCT02705807|P1|Participant Flow|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9854|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9855|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9856|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9857|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9889|NCT02705716|O2|Outcome|Control Dentifrice|Participants were instructed to apply a full brush head of control dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
9860|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9861|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9862|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9863|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9864|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9865|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9866|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9867|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9868|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9869|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9870|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9871|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9872|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9890|NCT02705716|O1|Outcome|Test Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
9873|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9874|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9875|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9876|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9877|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9878|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9879|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9880|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9881|NCT02705807|E1|Reported Event|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
9882|NCT02705716|B3|Baseline|Total|Total of all reporting groups
9883|NCT02705716|B2|Baseline|Control Dentifrice|Participants were instructed to apply a full brush head of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
9884|NCT02705716|B1|Baseline|Test Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
9885|NCT02705716|P2|Participant Flow|Control Dentifrice|Participants were instructed to apply a full brush head of control dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
9886|NCT02705716|P1|Participant Flow|Test Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
9887|NCT02705716|O2|Outcome|Control Dentifrice|Participants were instructed to apply a full brush head of control dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
9888|NCT02705716|O1|Outcome|Test Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
9998|NCT02701361|O1|Outcome|All Eligible Subjects Approached to Participate in the Study|All eligible subjects approached to participate in the study.
9891|NCT02705716|O2|Outcome|Control Dentifrice|Participants were instructed to apply a full brush head of control dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
9892|NCT02705716|O1|Outcome|Test Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
9893|NCT02705716|E2|Reported Event|Control Dentifrice|Participants were instructed to apply a full brush head of control dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
9894|NCT02705716|E1|Reported Event|Test Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
9895|NCT02705365|B3|Baseline|Total|Total of all reporting groups
9896|NCT02705365|B2|Baseline|Usual Care|"The control group will receive usual care during the 1-year study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results as well as smoking cessation guidance.~Usual Care: Usual care during the study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance."
9897|NCT02705365|B1|Baseline|Patient Navigation|"Patients assigned to the patient navigator (PN) arm will be sent a letter about the program with lung screening educational materials. The PN will educate eligible patients about lung screening, explore barriers to screening, coordinate scheduling an appointment with a provider, and possibly attend the visit with the patient. The PN will further coordinate scheduling the CT scan, help the patient obtain the test, and access any required follow-up. The PN will assess the patient’s interest in quitting smoking and if so, offer and help to connect the smoker to existing cessation resources in the community and provide follow-up contacts to monitor adherence to treatments.~Patient Navigation: One to one patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance."
9898|NCT02705365|P2|Participant Flow|Usual Care|"The control group will receive usual care during the 1-year study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results as well as smoking cessation guidance.~Usual Care: Usual care during the study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance."
9899|NCT02705365|P1|Participant Flow|Patient Navigation|"Patients assigned to the patient navigator (PN) arm will be sent a letter about the program with lung screening educational materials. The PN will educate eligible patients about lung screening, explore barriers to screening, coordinate scheduling an appointment with a provider, and possibly attend the visit with the patient. The PN will further coordinate scheduling the CT scan, help the patient obtain the test, and access any required follow-up. The PN will assess the patient’s interest in quitting smoking and if so, offer and help to connect the smoker to existing cessation resources in the community and provide follow-up contacts to monitor adherence to treatments.~Patient Navigation: One to one patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance."
9900|NCT02705365|O2|Outcome|Usual Care|"The control group will receive usual care during the 1-year study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results as well as smoking cessation guidance.~Usual Care: Usual care during the study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance."
9901|NCT02705365|O1|Outcome|Patient Navigation|"Patients assigned to the patient navigator (PN) arm will be sent a letter about the program with lung screening educational materials. The PN will educate eligible patients about lung screening, explore barriers to screening, coordinate scheduling an appointment with a provider, and possibly attend the visit with the patient. The PN will further coordinate scheduling the CT scan, help the patient obtain the test, and access any required follow-up. The PN will assess the patient’s interest in quitting smoking and if so, offer and help to connect the smoker to existing cessation resources in the community and provide follow-up contacts to monitor adherence to treatments.~Patient Navigation: One to one patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance."
9902|NCT02705365|O2|Outcome|Usual Care|"The control group will receive usual care during the 1-year study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results as well as smoking cessation guidance.~Usual Care: Usual care during the study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance."
9903|NCT02705365|O1|Outcome|Patient Navigation|"Patients assigned to the patient navigator (PN) arm will be sent a letter about the program with lung screening educational materials. The PN will educate eligible patients about lung screening, explore barriers to screening, coordinate scheduling an appointment with a provider, and possibly attend the visit with the patient. The PN will further coordinate scheduling the CT scan, help the patient obtain the test, and access any required follow-up. The PN will assess the patient’s interest in quitting smoking and if so, offer and help to connect the smoker to existing cessation resources in the community and provide follow-up contacts to monitor adherence to treatments.~Patient Navigation: One to one patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance."
9904|NCT02705365|E2|Reported Event|Usual Care|"The control group will receive usual care during the 1-year study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results as well as smoking cessation guidance.~Usual Care: Usual care during the study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance."
9905|NCT02705365|E1|Reported Event|Patient Navigation|"Patients assigned to the patient navigator (PN) arm will be sent a letter about the program with lung screening educational materials. The PN will educate eligible patients about lung screening, explore barriers to screening, coordinate scheduling an appointment with a provider, and possibly attend the visit with the patient. The PN will further coordinate scheduling the CT scan, help the patient obtain the test, and access any required follow-up. The PN will assess the patient’s interest in quitting smoking and if so, offer and help to connect the smoker to existing cessation resources in the community and provide follow-up contacts to monitor adherence to treatments.~Patient Navigation: One to one patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance."
9906|NCT02704689|B1|Baseline|AccuLIF TL|All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
9907|NCT02704689|P1|Participant Flow|AccuLIF TL|All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
9908|NCT02704689|O1|Outcome|AccuLIF TL|All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
9909|NCT02704689|O1|Outcome|AccuLIF TL|All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
9910|NCT02704689|O1|Outcome|AccuLIF TL|All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
9911|NCT02704689|O1|Outcome|AccuLIF TL|All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
9912|NCT02704689|O1|Outcome|AccuLIF TL|All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
9913|NCT02704689|O1|Outcome|AccuLIF TL|All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
9914|NCT02704689|O1|Outcome|AccuLIF TL|All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
9915|NCT02704689|O1|Outcome|AccuLIF TL|All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
9916|NCT02704689|O1|Outcome|AccuLIF TL|All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
9917|NCT02704689|O1|Outcome|AccuLIF TL|All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
9918|NCT02704689|O1|Outcome|AccuLIF TL|All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
9919|NCT02704689|O1|Outcome|AccuLIF TL|All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
9920|NCT02704689|O1|Outcome|AccuLIF TL|All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
9921|NCT02704689|O1|Outcome|AccuLIF TL|All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
9922|NCT02704689|E1|Reported Event|AccuLIF TL|All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
9923|NCT02703948|B1|Baseline|Restylane Silk With Lidocaine|Restylane Silk with Lidocaine
9924|NCT02703948|P1|Participant Flow|Restylane Silk With Lidocaine|Restylane Silk with Lidocaine
9925|NCT02703948|O1|Outcome|Restylane Silk With Lidocaine|Restylane Silk with Lidocaine
9926|NCT02703948|E1|Reported Event|Restylane Silk With Lidocaine|Restylane Silk with Lidocaine
9927|NCT02702011|B5|Baseline|Total|Total of all reporting groups
9928|NCT02702011|B4|Baseline|Empagliflozin 25 mg|Oral administration of 25 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 2.5 mg and 10 mg of empagliflozin during the 28 days randomized double-blinded treatment period.
9929|NCT02702011|B3|Baseline|Empagliflozin 10 mg|Oral administration of 10 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 2.5 mg and 25 mg of empagliflozin during the 28 days randomized double-blinded treatment period.
9930|NCT02702011|B2|Baseline|Empagliflozin 2.5 mg|Oral administration of 2.5 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 10 mg and 25 mg of empagliflozin during the 28 days randomized double-blinded treatment period
9931|NCT02702011|B1|Baseline|Placebo|Oral administration of matching placebo of 2.5 mg, 10 mg and 25 mg of empagliflozin film-coated tablets once daily during the 28 days randomized double-blinded treatment period.
9932|NCT02702011|P4|Participant Flow|Empagliflozin 25 mg|Oral administration of 25 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 2.5 mg and 10 mg of empagliflozin during the 28 days randomized double-blinded treatment period.
9933|NCT02702011|P3|Participant Flow|Empagliflozin 10 mg|Oral administration of 10 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 2.5 mg and 25 mg of empagliflozin during the 28 days randomized double-blinded treatment period.
9934|NCT02702011|P2|Participant Flow|Empagliflozin 2.5 mg|Oral administration of 2.5 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 10 mg and 25 mg of empagliflozin during the 28 days randomized double-blinded treatment period
9935|NCT02702011|P1|Participant Flow|Placebo|Oral administration of matching placebo of 2.5 mg, 10 mg and 25 mg of empagliflozin film-coated tablets once daily during the 28 days randomized double-blinded treatment period.
9936|NCT02702011|O4|Outcome|Empagliflozin 25 mg|Oral administration of 25 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 2.5 mg and 10 mg of empagliflozin during the 28 days randomized double-blinded treatment period.
9937|NCT02702011|O3|Outcome|Empagliflozin 10 mg|Oral administration of 10 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 2.5 mg and 25 mg of empagliflozin during the 28 days randomized double-blinded treatment period.
9938|NCT02702011|O2|Outcome|Empagliflozin 2.5 mg|Oral administration of 2.5 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 10 mg and 25 mg of empagliflozin during the 28 days randomized double-blinded treatment period
10060|NCT02699632|E1|Reported Event|All Participants|
9939|NCT02702011|O1|Outcome|Placebo|Oral administration of matching placebo of 2.5 mg, 10 mg and 25 mg of empagliflozin film-coated tablets once daily during the 28 days randomized double-blinded treatment period.
9940|NCT02702011|E4|Reported Event|Empagliflozin 25 mg|Oral administration of 25 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 2.5 mg and 10 mg of empagliflozin during the 28 days randomized double-blinded treatment period.
9941|NCT02702011|E3|Reported Event|Empagliflozin 10 mg|Oral administration of 10 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 2.5 mg and 25 mg of empagliflozin during the 28 days randomized double-blinded treatment period.
9942|NCT02702011|E2|Reported Event|Empagliflozin 2.5 mg|Oral administration of 2.5 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 10 mg and 25 mg of empagliflozin during the 28 days randomized double-blinded treatment period
9943|NCT02702011|E1|Reported Event|Placebo|Oral administration of matching placebo of 2.5 mg, 10 mg and 25 mg of empagliflozin film-coated tablets once daily during the 28 days randomized double-blinded treatment period.
9944|NCT02701556|B3|Baseline|Total|Total of all reporting groups
9945|NCT02701556|B2|Baseline|COMPLETE Multi-Purpose Solution|"B&L Multi-Purpose Solution as a rub care regimen (Control)~Complete Multi-Purpose Solution: a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses."
9946|NCT02701556|B1|Baseline|Bausch & Lomb Investigational NNR06 Multi-Purpose Solution|"B & L investigational NNR06 used as a rub care regimen (Test)~NNR06: an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses."
9947|NCT02701556|P2|Participant Flow|COMPLETE Multi-Purpose Solution|"B&L Multi-Purpose Solution as a rub care regimen (Control)~Complete Multi-Purpose Solution: a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses."
9948|NCT02701556|P1|Participant Flow|Bausch & Lomb Investigational NNR06 Multi-Purpose Solution|"B & L investigational NNR06 used as a rub care regimen (Test)~NNR06: an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses."
9949|NCT02701556|O2|Outcome|COMPLETE Multi-Purpose Solution|"B&L Multi-Purpose Solution as a rub care regimen (Control)~Complete Multi-Purpose Solution: a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses."
9950|NCT02701556|O1|Outcome|Bausch & Lomb Investigational NNR06 Multi-Purpose Solution|"B & L investigational NNR06 used as a rub care regimen (Test)~NNR06: an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses."
9951|NCT02701556|E2|Reported Event|COMPLETE Multi-Purpose Solution|"B&L Multi-Purpose Solution as a rub care regimen (Control)~Complete Multi-Purpose Solution: a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses."
9952|NCT02701556|E1|Reported Event|Bausch & Lomb Investigational NNR06 Multi-Purpose Solution|"B & L investigational NNR06 used as a rub care regimen (Test)~NNR06: an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses."
9953|NCT02701387|B1|Baseline|All Participants|Patients presenting to the study site in need of at least two dental implants received one of each implant type: Easy (EZ) Plus and AnyRidge (AR).
9954|NCT02701387|P1|Participant Flow|All Participants|Patients presenting to the study site in need of at least two dental implants received one of each implant type: Easy (EZ) Plus and AnyRidge (AR).
9955|NCT02701387|O2|Outcome|EZ Plus Implant|"Comparative implant (Megagen EZ Plus dental implant) placed in a healed edentulous site to replace a missing tooth.~Megagen EZ Plus dental implant: EZ Plus is an approved dental implant with a standard thread design (width and depth) and that is comparable to many other dental implants currently available on the market."
9956|NCT02701387|O1|Outcome|AnyRidge Implant|"Experimental implant (Megagen AnyRidge dental implant) placed in a healed edentulous site to replace a missing tooth.~Megagen AnyRidge dental implant: AnyRidge is an approved dental implant with a knife edge, thin thread design available in various thread widths (depth)."
9957|NCT02701387|E1|Reported Event|All Participants|Patients presenting to the study site in need of at least two dental implants received one of each implant type: Easy (EZ) Plus and AnyRidge (AR).
9958|NCT02701361|B4|Baseline|Total|Total of all reporting groups
9959|NCT02701361|B3|Baseline|Education Group|"A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.~education: Receives web-based content about critical illness topics. Also receives two calls from study team to describe materials and answer questions about materials."
9960|NCT02701361|B2|Baseline|Standard Mindfulness|"Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.~standard mindfulness: Receives weekly calls from mindfulness expert for 4 weeks."
9961|NCT02701361|B1|Baseline|Mobile Mindfulness|"Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.~mobile mindfulness: Receives audiovisual mindfulness content via internet plus call depending on symptoms or request."
9962|NCT02701361|P3|Participant Flow|Education Group|"A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.~education: Receives web-based content about critical illness topics. Also receives two calls from study team to describe materials and answer questions about materials."
9963|NCT02701361|P2|Participant Flow|Standard Mindfulness|"Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.~standard mindfulness: Receives weekly calls from mindfulness expert for 4 weeks."
9996|NCT02701361|O1|Outcome|Mobile Mindfulness|Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.
9964|NCT02701361|P1|Participant Flow|Mobile Mindfulness|"Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.~mobile mindfulness: Receives audiovisual mindfulness content via internet plus call depending on symptoms or request."
9965|NCT02701361|O3|Outcome|Education Group|A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.
9966|NCT02701361|O2|Outcome|Standard Mindfulness|Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.
9967|NCT02701361|O1|Outcome|Mobile Mindfulness|Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.
9968|NCT02701361|O3|Outcome|Education Group|A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.
9969|NCT02701361|O2|Outcome|Standard Mindfulness|Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.
9970|NCT02701361|O1|Outcome|Mobile Mindfulness|Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.
9971|NCT02701361|O3|Outcome|Education Group|A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.
9972|NCT02701361|O2|Outcome|Standard Mindfulness|Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.
9973|NCT02701361|O1|Outcome|Mobile Mindfulness|Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.
9974|NCT02701361|O3|Outcome|Education Group|A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.
9975|NCT02701361|O2|Outcome|Standard Mindfulness|Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.
9976|NCT02701361|O1|Outcome|Mobile Mindfulness|Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.
9977|NCT02701361|O3|Outcome|Education Group|A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.
9978|NCT02701361|O2|Outcome|Standard Mindfulness|Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.
9979|NCT02701361|O1|Outcome|Mobile Mindfulness|Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.
9980|NCT02701361|O3|Outcome|Education Group|A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.
9981|NCT02701361|O2|Outcome|Standard Mindfulness|Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.
9982|NCT02701361|O1|Outcome|Mobile Mindfulness|Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.
9983|NCT02701361|O1|Outcome|Mobile Mindfulness|Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.
9984|NCT02701361|O1|Outcome|Mobile Mindfulness|Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.
9985|NCT02701361|O1|Outcome|Mobile Mindfulness|Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.
9986|NCT02701361|O1|Outcome|Mobile Mindfulness|Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.
9987|NCT02701361|O3|Outcome|Education Group|A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.
9988|NCT02701361|O2|Outcome|Standard Mindfulness|Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.
9989|NCT02701361|O1|Outcome|Mobile Mindfulness|Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.
9990|NCT02701361|O3|Outcome|Education Group|A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.
9991|NCT02701361|O2|Outcome|Standard Mindfulness|Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.
9992|NCT02701361|O1|Outcome|Mobile Mindfulness|Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.
9993|NCT02701361|O1|Outcome|Mobile Mindfulness|Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.
9994|NCT02701361|O3|Outcome|Education Group|A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.
9995|NCT02701361|O2|Outcome|Standard Mindfulness|Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.
9999|NCT02701361|E3|Reported Event|Education Group|A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.
10000|NCT02701361|E2|Reported Event|Standard Mindfulness|Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.
10001|NCT02701361|E1|Reported Event|Mobile Mindfulness|Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.
10002|NCT02701296|B3|Baseline|Total|Total of all reporting groups
10003|NCT02701296|B2|Baseline|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine~Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
10004|NCT02701296|B1|Baseline|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine~Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
10005|NCT02701296|P2|Participant Flow|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine~Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
10006|NCT02701296|P1|Participant Flow|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine~Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
10007|NCT02701296|O2|Outcome|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine~Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
10008|NCT02701296|O1|Outcome|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine~Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
10009|NCT02701296|O2|Outcome|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine~Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
10010|NCT02701296|O1|Outcome|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine~Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
10011|NCT02701296|O2|Outcome|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine~Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
10012|NCT02701296|O1|Outcome|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine~Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
10013|NCT02701296|O2|Outcome|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine~Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
10014|NCT02701296|O1|Outcome|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine~Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
10015|NCT02701296|O2|Outcome|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine~Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
10016|NCT02701296|O1|Outcome|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine~Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
10017|NCT02701296|O2|Outcome|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine~Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
10018|NCT02701296|O1|Outcome|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine~Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
10019|NCT02701296|E2|Reported Event|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine~Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
10020|NCT02701296|E1|Reported Event|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine~Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
10021|NCT02701270|B1|Baseline|All Study Participants|All participants received every study intervention in randomized order: Experimental Dietary Fibre 1 and 2, Polydextrose and Dextrose
10022|NCT02701270|P4|Participant Flow|Fibre 2 First, Then Polydextrose, Dextrose and Fibre1|Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 21.48 g Dietary Fibre 2, at second visit 21.48 g Polydextrose Control, at third visit 23.89 g Dextrose Control and at fourth visit 22.17 g Dietary Fibre 1.
10023|NCT02701270|P3|Participant Flow|Fibre1 First, Then Fibre 2, Polydextrose and Dextrose|Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 22.17 g Dietary Fibre 1, at second visit 21.48 g Dietary Fibre 2, at third visit 21.48 g Polydextrose Control and at fourth visit 23.89 g Dextrose Control.
10024|NCT02701270|P2|Participant Flow|Dextrose First, Then Fibre1, Fibre 2 and Polydextrose|Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 23.89 g Dextrose Control, at second visit 22.17 g Dietary Fibre 1, at third visit 21.48 g Dietary Fibre 2 and at fourth visit 21.48 g Polydextrose Control.
17628|NCT02577016|B3|Baseline|Total|Total of all reporting groups
10025|NCT02701270|P1|Participant Flow|Polydextrose First, Then Dextrose, Fibre1 and Fibre 2|Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 21.48 g Polydextrose Control, at second visit 23.89 g Dextrose Control, at third visit 22.17 g Dietary Fibre 1 and at fourth visit 21.48 g Dietary Fibre 2.
10026|NCT02701270|O4|Outcome|Dextrose Control|Dextrose: 23.89 g of dextrose diluted in 250 ml of water taken once orally.
10027|NCT02701270|O3|Outcome|Polydextrose|Polydextrose: 21.48 g of product diluted in 250 ml of water taken once orally.
10028|NCT02701270|O2|Outcome|Experimental Dietary Fibre 2|Experimental Dietary Fibre 2: 21.84 g of product diluted in 250 ml of water taken once orally.
10029|NCT02701270|O1|Outcome|Experimental Dietary Fibre 1|Experimental Dietary Fibre 1: 22.17 g of product diluted in 250 ml of water taken once orally.
10030|NCT02701270|O4|Outcome|Dextrose Control|Dextrose: 23.89 g of dextrose diluted in 250 ml of water taken once orally.
10031|NCT02701270|O3|Outcome|Polydextrose Control|Polydextrose: 21.48 g of product diluted in 250 ml of water taken once orally.
10032|NCT02701270|O2|Outcome|Experimental Dietary Fibre 2|Experimental Dietary Fibre 2: 21.84 g of product diluted in 250 ml of water taken once orally.
10033|NCT02701270|O1|Outcome|Experimental Dietary Fibre 1|Experimental Dietary Fibre 1: 22.17 g of product diluted in 250 ml of water taken once orally.
10034|NCT02701270|E4|Reported Event|Dextrose Control|Dextrose: 23.89 g of dextrose diluted in 250 ml of water taken once orally.
10035|NCT02701270|E3|Reported Event|Polydextrose Control|Polydextrose: 21.48 g of product diluted in 250 ml of water taken once orally.
10036|NCT02701270|E2|Reported Event|Experimental Dietary Fibre 2|Experimental Dietary Fibre 2: 21.84 g of product diluted in 250 ml of water taken once orally.
10037|NCT02701270|E1|Reported Event|Experimental Dietary Fibre 1|Experimental Dietary Fibre 1: 22.17 g of product diluted in 250 ml of water taken once orally.
10038|NCT02699892|B1|Baseline|Rheumatoid Arthritis Participants|Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
10039|NCT02699892|P1|Participant Flow|Rheumatoid Arthritis Participants|Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
10040|NCT02699892|O1|Outcome|Rheumatoid Arthritis Participants|Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
10041|NCT02699892|O1|Outcome|Rheumatoid Arthritis Participants|Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
10042|NCT02699892|E1|Reported Event|Rheumatoid Arthritis Participants|Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
10043|NCT02699684|B1|Baseline|Overall|Lotrafilcon B contact lenses with EOBO-41 and lotrafilcon B contact lenses worn bilaterally during Period 1 and Period 2 in a crossover assignment, as randomized.
10044|NCT02699684|P2|Participant Flow|AOA, Then AOHG|Lotrafilcon B contact lenses worn first, followed by lotrafilcon B contact lenses with EOBO-41 worn second. Both products worn bilaterally for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
10045|NCT02699684|P1|Participant Flow|AOHG, Then AOA|Lotrafilcon B contact lenses with EOBO-41 worn first, followed by lotrafilcon B contact lenses worn second. Both products worn bilaterally (in both eyes) for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
10046|NCT02699684|O1|Outcome|AOHG Contact Lenses|Lotrafilcon B contact lenses with EOBO-41 worn bilaterally for 30 days in Period 1 or 2, as randomized
10047|NCT02699684|O2|Outcome|AOA Contact Lenses|Lotrafilcon B contact lenses worn bilaterally for 30 days in Period 1 or 2, as randomized
10048|NCT02699684|O1|Outcome|AOHG Contact Lenses|Lotrafilcon B contact lenses with EOBO-41 worn bilaterally for 30 days in Period 1 or 2, as randomized
10049|NCT02699684|O2|Outcome|AOA Contact Lenses|Lotrafilcon B contact lenses worn bilaterally for 30 days in Period 1 or 2, as randomized
10050|NCT02699684|O1|Outcome|AOHG Contact Lenses|Lotrafilcon B contact lenses with EOBO-41 worn bilaterally for 30 days in Period 1 or 2, as randomized
10051|NCT02699684|E3|Reported Event|AOA Contact Lenses|All subjects exposed to AOA contact lenses
10052|NCT02699684|E2|Reported Event|AOHG Contact Lenses|All subjects exposed to AOHG contact lenses
10053|NCT02699684|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to initiation of study treatment
10054|NCT02699632|B1|Baseline|All Participants|"Women previously, currently, or planning to become pregnant. Data utilized is from completed questionnaires only, is uncorrected, and was collected from January through June 2016.~Mode of initial contact with potential participants was made on the Internet (email and Facebook posts). Participants were instructed of survey length in these Internet advertisements and study purpose and data storage information on the first page of our electronic survey.~No incentives were offered to participants, no protected health information was collected, and no measures were used for prevention of multiple entries from the same individual."
10055|NCT02699632|P1|Participant Flow|All Participants|"The survey was taken by 360 women previously, currently, or planning to become pregnant.~Although number of unique site visitors between January and June 2016 is indeterminable, we had a completion rate of 69% (the percentage of surveys completed out of the total number initiated, ie, number of page 2 completions and number of page 1 completions)."
10056|NCT02699632|O1|Outcome|All Participants|Survey respondents were asked about their concerns and what could be done to help minimize those concerns.
10057|NCT02699632|O1|Outcome|All Participants|Survey respondents were asked about their comfort and whether or not their physician needed to be involved.
10058|NCT02699632|O1|Outcome|All Participants|Survey respondents were asked how they would prefer to learn about a research study
10059|NCT02699632|O1|Outcome|All Participants|Respondents were asked what types of research they were willing to participate in during pregnancy
10062|NCT02699593|P2|Participant Flow|Senofilcon A(Control)/Senofilcon A(Test)|Subjects that were randomized to receive the control lens senofilcon A first and then the test lens senofilcon A lens second.
10063|NCT02699593|P1|Participant Flow|Senofilcon A(Test)/Senofilcon A(Control)|Subjects that were randomized to receive the test lens senofilcon A lens first and then the control lens senofilcon A lens second.
10064|NCT02699593|O2|Outcome|Senofilcon A (Control)|Subjects that wore the control lens senofilcon A lens during the first or second period of the study.
10065|NCT02699593|O1|Outcome|Senofilcon A (Test)|Subjects that wore the test lens senofilcon A during either the first or second period of the study.
10066|NCT02699593|O2|Outcome|Senofilcon A (Control)|Subjects that wore the control lens senofilcon A lens during the first or second period of the study.
10067|NCT02699593|O1|Outcome|Senofilcon A (Test)|Subjects that wore the test lens senofilcon A during either the first or second period of the study.
10068|NCT02699593|E2|Reported Event|Senofilcon A (Control)|Subjects that wore the control lens senofilcon A lens during the first or second period of the study.
10069|NCT02699593|E1|Reported Event|Senofilcon A (Test)|Subjects that wore the test lens senofilcon A during either the first or second period of the study.
10070|NCT02698566|B1|Baseline|Ranibizumab PFS|HCPs administered ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
10071|NCT02698566|P2|Participant Flow|Ranibizumab PFS - HCPs|HCPs administered ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
10072|NCT02698566|P1|Participant Flow|Ranibizumab PFS - Patients|Healthcare professionals (HCPs) administered ITV injections of ranibizumab 0.5 milligrams (mg) delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
10073|NCT02698566|O1|Outcome|Ranibizumab PFS|HCPs administered ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
10074|NCT02698566|O1|Outcome|Ranibizumab PFS|HCPs administered ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
10075|NCT02698566|O1|Outcome|Ranibizumab PFS|HCPs administered ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
10076|NCT02698566|E1|Reported Event|Ranibizumab PFS|HCPs administered ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
10077|NCT02698436|B3|Baseline|Total|Total of all reporting groups
10078|NCT02698436|B2|Baseline|2.5% Benzoyl Peroxide Treatment|Applied BPO treatment once daily
10079|NCT02698436|B1|Baseline|Acne Mask|Light therapy mask applied to the face once in the evening for a duration of 10 minutes
10080|NCT02698436|P2|Participant Flow|Benzoyl Peroxide 2.5%|Apply test product to face once in the morning and once at night.
10081|NCT02698436|P1|Participant Flow|Acne Mask|Light therapy mask applied to the face once in the evening for a duration of 10 minutes
10082|NCT02698436|O2|Outcome|2.5% Benzoyl Peroxide|Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
10083|NCT02698436|O1|Outcome|Acne Mask|Light therapy mask applied to the face once in the evening for a duration of 10 minutes
10084|NCT02698436|O2|Outcome|2.5% Benzoyl Peroxide|Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
10085|NCT02698436|O1|Outcome|Acne Mask|Light therapy mask applied to the face once in the evening for a duration of 10 minutes
10086|NCT02698436|O2|Outcome|2.5% Benzoyl Peroxide|Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
10087|NCT02698436|O1|Outcome|Acne Mask|Light therapy mask applied to the face once in the evening for a duration of 10 minutes
10088|NCT02698436|O2|Outcome|2.5% Benzoyl Peroxide|Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
10089|NCT02698436|O1|Outcome|Acne Mask|Light therapy mask applied to the face once in the evening for a duration of 10 minutes
10090|NCT02698436|O2|Outcome|2.5% Benzoyl Peroxide|Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
10091|NCT02698436|O1|Outcome|Acne Mask|Light therapy mask applied to the face once in the evening for a duration of 10 minutes
10092|NCT02698436|O2|Outcome|2.5% Benzoyl Peroxide|Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
10093|NCT02698436|O1|Outcome|Acne Mask|Light therapy mask applied to the face once in the evening for a duration of 10 minutes
10094|NCT02698436|O2|Outcome|2.5% Benzoyl Peroxide|Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
10095|NCT02698436|O1|Outcome|Acne Mask|Light therapy mask applied to the face once in the evening for a duration of 10 minutes
10096|NCT02698436|O2|Outcome|2.5% Benzoyl Peroxide|Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
10097|NCT02698436|O1|Outcome|Acne Mask|Light therapy mask applied to the face once in the evening for a duration of 10 minutes
10098|NCT02698436|O2|Outcome|2.5% Benzoyl Peroxide|Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
10099|NCT02698436|O1|Outcome|Acne Mask|Light therapy mask applied to the face once in the evening for a duration of 10 minutes
10100|NCT02698436|O2|Outcome|2.5% Benzoyl Peroxide|Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
10101|NCT02698436|O1|Outcome|Acne Mask|Light therapy mask applied to the face once in the evening for a duration of 10 minutes
10102|NCT02698436|O2|Outcome|2.5% Benzoyl Peroxide|Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
10103|NCT02698436|O1|Outcome|Acne Mask|Light therapy mask applied to the face once in the evening for a duration of 10 minutes
10104|NCT02698436|O2|Outcome|2.5% Benzoyl Peroxide|Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
10105|NCT02698436|O1|Outcome|Acne Mask|Light therapy mask applied to the face once in the evening for a duration of 10 minutes
10106|NCT02698436|O2|Outcome|2.5% Benzoyl Peroxide|Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
10107|NCT02698436|O1|Outcome|Acne Mask|Light therapy mask applied to the face once in the evening for a duration of 10 minutes
10108|NCT02698436|O2|Outcome|2.5% Benzoyl Peroxide|Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
10109|NCT02698436|O1|Outcome|Acne Mask|Light therapy mask applied to the face once in the evening for a duration of 10 minutes
10110|NCT02698436|O2|Outcome|2.5% Benzoyl Peroxide|Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
10111|NCT02698436|O1|Outcome|Acne Mask|Light therapy mask applied to the face once in the evening for a duration of 10 minutes
10112|NCT02698436|O2|Outcome|2.5% Benzoyl Peroxide|Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
10113|NCT02698436|O1|Outcome|Acne Mask|Light therapy mask applied to the face once in the evening for a duration of 10 minutes
10114|NCT02698436|O2|Outcome|2.5% Benzoyl Peroxide|Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
10115|NCT02698436|O1|Outcome|Acne Mask|Light therapy mask applied to the face once in the evening for a duration of 10 minutes
10116|NCT02698436|E2|Reported Event|2.5% Benzoyl Peroxide Treatment|Applied BPO treatment once daily
10117|NCT02698436|E1|Reported Event|Acne Mask|Light therapy mask applied to the face once in the evening for a duration of 10 minutes
10118|NCT02698423|B3|Baseline|Total|Total of all reporting groups
10119|NCT02698423|B2|Baseline|Papanicolau Test|"Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.~Papanicolau test: Women will be invited to come in for a physician-performed Pap test"
10120|NCT02698423|B1|Baseline|Cobas HPV DNA Test|"Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.~Cobas HPV DNA Test: Women will receive a home-sent sample for HPV self-testing"
10121|NCT02698423|P2|Participant Flow|Papanicolau Test|"Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.~Papanicolau test: Women will be invited to come in for a physician-performed Pap test."
10122|NCT02698423|P1|Participant Flow|Cobas HPV DNA Test|"Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.~Cobas HPV DNA Test: Women will receive a home-sent sample for HPV self-testing."
10123|NCT02698423|O2|Outcome|Papanicolau Test|"Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.~Papanicolau test: Women will be invited to come in for a physician-performed Pap test.~N=331"
10124|NCT02698423|O1|Outcome|Cobas HPV DNA Test|"Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.~Cobas HPV DNA Test: Women will receive a home-sent sample for HPV self-testing. N=336"
10125|NCT02698423|E2|Reported Event|Papanicolau Test|"Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.~Papanicolau test: Women will be invited to come in for a physician-performed Pap test.~N=331"
10126|NCT02698423|E1|Reported Event|Cobas HPV DNA Test|"Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.~Cobas HPV DNA Test: Women will receive a home-sent sample for HPV self-testing. N=336"
10127|NCT02697890|B3|Baseline|Total|Total of all reporting groups
10128|NCT02697890|B2|Baseline|FDBA (MinerOss®) + Mucograft® Seal|"Interventions:~Device: Mucograft® seal Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration"
10129|NCT02697890|B1|Baseline|FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)|"Interventions:~Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care"
10130|NCT02697890|P2|Participant Flow|FDBA (MinerOss®) + Mucograft® Seal|"Interventions:~Device: Mucograft® seal Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration"
10131|NCT02697890|P1|Participant Flow|FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)|"Interventions:~Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care"
10132|NCT02697890|O2|Outcome|FDBA (MinerOss®) + Mucograft® Seal|"Interventions:~Device: Mucograft® seal Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration"
10133|NCT02697890|O1|Outcome|FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)|"Interventions:~Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care"
10134|NCT02697890|O2|Outcome|FDBA (MinerOss®) + Mucograft® Seal|"Interventions:~Device: Mucograft® seal Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration"
10135|NCT02697890|O1|Outcome|FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)|"Interventions:~Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care"
10136|NCT02697890|O2|Outcome|FDBA (MinerOss®) + Mucograft® Seal|"Interventions:~Device: Mucograft® seal Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration"
10137|NCT02697890|O1|Outcome|FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)|"Interventions:~Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care"
10138|NCT02697890|O2|Outcome|FDBA (MinerOss®) + Mucograft® Seal|"Interventions:~Device: Mucograft® seal Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration"
10139|NCT02697890|O1|Outcome|FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)|"Interventions:~Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care"
10140|NCT02697890|E2|Reported Event|FDBA (MinerOss®) + Mucograft® Seal|"Interventions:~Device: Mucograft® seal Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration"
10141|NCT02697890|E1|Reported Event|FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)|"Interventions:~Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care"
10142|NCT02696317|B1|Baseline|Overall|Habitual contact lenses worn first, followed by senofilcon A contact lenses with HydraLuxe™ and senofilcon A contact lenses in Periods 1 and 2, as randomized. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
10143|NCT02696317|P2|Participant Flow|Habitual, AO, AO1D|Habitual contact lenses worn first (to understand the baseline performance in this population), followed by senofilcon A contact lenses in Period 1, then senofilcon A contact lenses with HydraLuxe™ in Period 2. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
10144|NCT02696317|P1|Participant Flow|Habitual, AO1D, AO|Habitual contact lenses worn first (to understand the baseline performance in this population), followed by senofilcon A contact lenses with HydraLuxe™ in Period 1 and senofilcon A contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality.
10145|NCT02696317|O2|Outcome|ACUVUE OASYS|Senofilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
10146|NCT02696317|O1|Outcome|ACUVUE OASYS 1-DAY|Senofilcon A contact lenses with HydraLuxe™ worn bilaterally for 10 days in a daily wear, daily disposable modality
10147|NCT02696317|O2|Outcome|ACUVUE OASYS|Senofilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
10148|NCT02696317|O1|Outcome|ACUVUE OASYS 1-DAY|Senofilcon A contact lenses with HydraLuxe™ worn bilaterally for 10 days in a daily wear, daily disposable modality
10149|NCT02696317|O2|Outcome|ACUVUE OASYS|Senofilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
10150|NCT02696317|O1|Outcome|ACUVUE OASYS 1-DAY|Senofilcon A contact lenses with HydraLuxe™ worn bilaterally for 10 days in a daily wear, daily disposable modality
10151|NCT02696317|O2|Outcome|ACUVUE OASYS|Senofilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
10152|NCT02696317|O1|Outcome|ACUVUE OASYS 1-DAY|Senofilcon A contact lenses with HydraLuxe™ worn bilaterally for 10 days in a daily wear, daily disposable modality
10153|NCT02696317|E4|Reported Event|ACUVUE OASYS|All subjects exposed to ACUVUE OASYS contact lenses
10154|NCT02696317|E3|Reported Event|ACUVUE OASYS 1-DAY|All subjects exposed to ACUVUE OASYS 1-DAY contact lenses
10155|NCT02696317|E2|Reported Event|Habitual Lenses|All subjects exposed to habitual contact lenses during Period 1
10156|NCT02696317|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to initiation of study treatment
10157|NCT02696291|B3|Baseline|Total|Total of all reporting groups
10158|NCT02696291|B2|Baseline|Cohort 1 - Placebo|Subjects receiving placebo TID (every 8 ± 0.5 hours) for 7 days
10159|NCT02696291|B1|Baseline|Cohort 1 - 30 mg UV-4B|Subjects receiving UV-4B 30 mg oral solution TID (every 8 ± 0.5 hours) for 7 days
10160|NCT02696291|P2|Participant Flow|Cohort 1 - Placebo|Subjects receiving placebo TID (every 8 ± 0.5 hours) for 7 days
10161|NCT02696291|P1|Participant Flow|Cohort 1 - 30 mg UV-4B|Subjects receiving UV-4B 30 mg oral solution TID (every 8 ± 0.5 hours) for 7 days
10162|NCT02696291|O1|Outcome|Cohort 1 - 30 mg UV-4B|Subjects receiving UV-4B 30 mg oral solution TID (every 8 ± 0.5 hours) for 7 days
10163|NCT02696291|O1|Outcome|Cohort 1 - 30 mg UV-4B|Subjects receiving UV-4B 30 mg oral solution TID (every 8 ± 0.5 hours) for 7 days
10164|NCT02696291|O1|Outcome|Cohort 1 - 30 mg UV-4B|Subjects receiving UV-4B 30 mg oral solution TID (every 8 ± 0.5 hours) for 7 days
10165|NCT02696291|O1|Outcome|Cohort 1 - 30 mg UV-4B|Subjects receiving UV-4B 30 mg oral solution TID (every 8 ± 0.5 hours) for 7 days
10166|NCT02696291|O1|Outcome|Cohort 1 - 30 mg UV-4B|Subjects receiving UV-4B 30 mg oral solution TID (every 8 ± 0.5 hours) for 7 days
10167|NCT02696291|O1|Outcome|Cohort 1 - 30 mg UV-4B|Subjects receiving UV-4B 30 mg oral solution TID (every 8 ± 0.5 hours) for 7 days
10168|NCT02696291|O1|Outcome|Cohort 1 - 30 mg UV-4B|Subjects receiving UV-4B 30 mg oral solution TID (every 8 ± 0.5 hours) for 7 days
10169|NCT02696291|O1|Outcome|Cohort 1 - 30 mg UV-4B|Subjects receiving UV-4B 30 mg oral solution TID (every 8 ± 0.5 hours) for 7 days
10170|NCT02696291|O1|Outcome|Cohort 1 - 30 mg UV-4B|Subjects receiving UV-4B 30 mg oral solution TID (every 8 ± 0.5 hours) for 7 days
10171|NCT02696291|O2|Outcome|Cohort 1 - Placebo|Subjects receiving placebo TID (every 8 ± 0.5 hours) for 7 days
10172|NCT02696291|O1|Outcome|Cohort 1 - 30 mg UV-4B|Subjects receiving UV-4B 30 mg oral solution TID (every 8 ± 0.5 hours) for 7 days
10173|NCT02696291|O2|Outcome|Cohort 1 - Placebo|Subjects receiving placebo TID (every 8 ± 0.5 hours) for 7 days
10174|NCT02696291|O1|Outcome|Cohort 1 - 30 mg UV-4B|Subjects receiving UV-4B 30 mg oral solution TID (every 8 ± 0.5 hours) for 7 days
10175|NCT02696291|O2|Outcome|Cohort 1 - Placebo|Subjects receiving placebo TID (every 8 ± 0.5 hours) for 7 days
10176|NCT02696291|O1|Outcome|Cohort 1 - 30 mg UV-4B|Subjects receiving UV-4B 30 mg oral solution TID (every 8 ± 0.5 hours) for 7 days
10177|NCT02696291|O2|Outcome|Cohort 1 - Placebo|Subjects receiving placebo TID (every 8 ± 0.5 hours) for 7 days
10178|NCT02696291|O1|Outcome|Cohort 1 - 30 mg UV-4B|Subjects receiving UV-4B 30 mg oral solution TID (every 8 ± 0.5 hours) for 7 days
10179|NCT02696291|O2|Outcome|Cohort 1 - Placebo|Subjects receiving placebo TID (every 8 ± 0.5 hours) for 7 days
10180|NCT02696291|O1|Outcome|Cohort 1 - 30 mg UV-4B|Subjects receiving UV-4B 30 mg oral solution TID (every 8 ± 0.5 hours) for 7 days
10181|NCT02696291|E2|Reported Event|Cohort 1 - Placebo|Subjects receiving placebo TID (every 8 ± 0.5 hours) for 7 days
10182|NCT02696291|E1|Reported Event|Cohort 1 - 30 mg UV-4B|Subjects receiving UV-4B 30 mg oral solution TID (every 8 ± 0.5 hours) for 7 days
10183|NCT02696226|B5|Baseline|Total|Total of all reporting groups
10184|NCT02696226|B4|Baseline|TAVR Aspirin and Clopidogrel Arm|"Aspirin (81mg/day) and Clopidogrel (75mg/day) arm~TAVR Aspirin and clopidogrel: Aspirin (81 mg/day) and clopidogrel (75 mg/day) in periprocedural period and continue for 24 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely"
10185|NCT02696226|B3|Baseline|SAVR Aspirin Arm|"Aspirin arm (81mg/day)~SAVR Aspirin: Aspirin (81 mg/day) to begin within 1-3 postoperative days according to the patient’s clinical status and continue indefinitely per standard of care."
10210|NCT02696070|B2|Baseline|Active Treatment|Acitve Provant Therapy System. Subjects were instructed to treatment with an active Provant Therapy Unit that emitted a pulsed electromagnet field.
10211|NCT02696070|B1|Baseline|Sham of Provant|Inactive / sham Provant Therapy System. Subjects were instructed to treatment with an inactive Provant Therapy Unit that did not emit a pulsed electromagnet field.
10186|NCT02696226|B2|Baseline|TAVR Warfarin and Clopidogrel Arm|"Warfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm~TAVR Warfarin and clopidogrel: Begin Warfarin and clopidogrel (75 mg/day) treatment within 1-3 days postop for 12 weeks with a target INR of 2-3 When warfarin is discontinued, begin aspirin (81 mg/day) and continue aspirin/clopidogrel for 12 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely"
10187|NCT02696226|B1|Baseline|SAVR Warfarin Arm|"Warfarin arm-(target INR of 2-3)~SAVR Warfarin: Warfarin treatment for 12 weeks with a target INR of 2-3 Warfarin treatment to begin on postoperative day 1-3 according to the patient’s clinical status When warfarin treatment is discontinued, patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely"
10188|NCT02696226|P4|Participant Flow|TAVR Aspirin and Clopidogrel Arm|"Aspirin (81mg/day) and Clopidogrel (75mg/day) arm~TAVR Aspirin and clopidogrel: Aspirin (81 mg/day) and clopidogrel (75 mg/day) in periprocedural period and continue for 24 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely"
10189|NCT02696226|P3|Participant Flow|SAVR Aspirin Arm|"Aspirin arm (81mg/day)~SAVR Aspirin: Aspirin (81 mg/day) to begin within 1-3 postoperative days according to the patient’s clinical status and continue indefinitely per standard of care."
10190|NCT02696226|P2|Participant Flow|TAVR Warfarin and Clopidogrel Arm|"Warfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm~TAVR Warfarin and clopidogrel: Begin Warfarin and clopidogrel (75 mg/day) treatment within 1-3 days postop for 12 weeks with a target INR of 2-3 When warfarin is discontinued, begin aspirin (81 mg/day) and continue aspirin/clopidogrel for 12 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely"
10191|NCT02696226|P1|Participant Flow|SAVR Warfarin Arm|"Warfarin arm-(target INR of 2-3)~SAVR Warfarin: Warfarin treatment for 12 weeks with a target INR of 2-3 Warfarin treatment to begin on postoperative day 1-3 according to the patient’s clinical status When warfarin treatment is discontinued, patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely"
10192|NCT02696226|O4|Outcome|TAVR Aspirin and Clopidogrel Arm|"Aspirin (81mg/day) and Clopidogrel (75mg/day) arm~TAVR Aspirin and clopidogrel: Aspirin (81 mg/day) and clopidogrel (75 mg/day) in periprocedural period and continue for 24 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely"
10193|NCT02696226|O3|Outcome|SAVR Aspirin Arm|"Aspirin arm (81mg/day)~SAVR Aspirin: Aspirin (81 mg/day) to begin within 1-3 postoperative days according to the patient’s clinical status and continue indefinitely per standard of care."
10194|NCT02696226|O2|Outcome|TAVR Warfarin and Clopidogrel Arm|"Warfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm~TAVR Warfarin and clopidogrel: Begin Warfarin and clopidogrel (75 mg/day) treatment within 1-3 days postop for 12 weeks with a target INR of 2-3 When warfarin is discontinued, begin aspirin (81 mg/day) and continue aspirin/clopidogrel for 12 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely"
10195|NCT02696226|O1|Outcome|SAVR Warfarin Arm|"Warfarin arm-(target INR of 2-3)~SAVR Warfarin: Warfarin treatment for 12 weeks with a target INR of 2-3 Warfarin treatment to begin on postoperative day 1-3 according to the patient’s clinical status When warfarin treatment is discontinued, patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely"
10196|NCT02696226|E4|Reported Event|TAVR Aspirin and Clopidogrel Arm|"Aspirin (81mg/day) and Clopidogrel (75mg/day) arm~TAVR Aspirin and clopidogrel: Aspirin (81 mg/day) and clopidogrel (75 mg/day) in periprocedural period and continue for 24 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely"
10197|NCT02696226|E3|Reported Event|SAVR Aspirin Arm|"Aspirin arm (81mg/day)~SAVR Aspirin: Aspirin (81 mg/day) to begin within 1-3 postoperative days according to the patient’s clinical status and continue indefinitely per standard of care."
10198|NCT02696226|E2|Reported Event|TAVR Warfarin and Clopidogrel Arm|"Warfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm~TAVR Warfarin and clopidogrel: Begin Warfarin and clopidogrel (75 mg/day) treatment within 1-3 days postop for 12 weeks with a target INR of 2-3 When warfarin is discontinued, begin aspirin (81 mg/day) and continue aspirin/clopidogrel for 12 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely"
10199|NCT02696226|E1|Reported Event|SAVR Warfarin Arm|"Warfarin arm-(target INR of 2-3)~SAVR Warfarin: Warfarin treatment for 12 weeks with a target INR of 2-3 Warfarin treatment to begin on postoperative day 1-3 according to the patient’s clinical status When warfarin treatment is discontinued, patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely"
10200|NCT02696083|B1|Baseline|Active Treatment|Provant Therapy System
10201|NCT02696083|P1|Participant Flow|Active Treatment (Provant Therapy System)|Provant Therapy System
10202|NCT02696083|O6|Outcome|MPP Proteins|The 4 matrix metalloproteinase proteins analyzed in this group include the following: MMP-2, MMP-3, MMP-9, and MMP-13.
10203|NCT02696083|O5|Outcome|Adhesion and Matrix Proteins|This group includes 4 adhesion and matrix metalloproteinase proteins: ICAM-1, P-CadH, VCAM-1, and VE-CadH.
10204|NCT02696083|O4|Outcome|Bone Remodeling Related Proteins|The 6 synovial fluid markers in this group included monocyte chemoattractant protein-1, macrophage colony-stimulating factor, macrophage inflammatory protein, receptor activator of Nuclear factor κ, and TNF related activation induced cytokine (MCP-1, M-CSF, MIP-1a, RANK, TRANCE).
10205|NCT02696083|O3|Outcome|Growth Factors and Related Proteins|The 10 synovial markers included in this group include Growth Factors and Related Proteins fibroblast growth factors 1,2, androgen receptor, platelet derived growth factor BB, tumor growth factor beta, osteprogenerin, osteopontin, and Insulin like growth factor-1 (FGF-1, FGF-2, AR, PDGF BB, TGF b1, TGF b2, TGF b3, OPG, OPN and IGF-1
10206|NCT02696083|O2|Outcome|Cytokines|The 7 synovial markers measured included the levels of interleukin cytokines and tumor necrosis factor alpha (Il-1α, IL-1β, IL-6, IL-8, IL-11, IL-17 and TNFα),
10207|NCT02696083|O1|Outcome|BMP and Related Proteins|BMP and related protein synovial markers measured included 9 markers: bone morphologic proteins (BMP-2, BMP-4, BMP-6, BMP-7, BMP-9) and related proteins Activin A, Osteoactivin (Ostact), sonic hedgehog (Shh N) and Dickkopf (DKK-1).
10208|NCT02696083|E1|Reported Event|Active Treatment|Provant Therapy System
10209|NCT02696070|B3|Baseline|Total|Total of all reporting groups
20053|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
10212|NCT02696070|P2|Participant Flow|Active Treatment|Acitve Provant Therapy System. Subjects were instructed to treatment with an active Provant Therapy Unit that emitted a pulsed electromagnet field.
10213|NCT02696070|P1|Participant Flow|Sham of Provant|Inactive / sham Provant Therapy System. Subjects were instructed to treatment with an inactive Provant Therapy Unit that did not emit a pulsed electromagnet field.
10214|NCT02696070|O2|Outcome|Active Treatment|Acitve Provant Therapy System. Subjects were instructed to treatment with an active Provant Therapy Unit that emitted a pulsed electromagnet field.
10215|NCT02696070|O1|Outcome|Sham of Provant|Inactive / sham Provant Therapy System. Subjects were instructed to treatment with an inactive Provant Therapy Unit that did not emit a pulsed electromagnet field.
10216|NCT02696070|E2|Reported Event|Active Treatment|Acitve Provant Therapy System. Subjects were instructed to treatment with an active Provant Therapy Unit that emitted a pulsed electromagnet field.
10217|NCT02696070|E1|Reported Event|Sham of Provant|Inactive / sham Provant Therapy System. Subjects were instructed to treatment with an inactive Provant Therapy Unit that did not emit a pulsed electromagnet field.
10218|NCT02695446|B1|Baseline|Oral ER Minocycline - Up to 2mg/kg|"Oral extended release minocycline - up to 2mg/kg once a day for 30 days.~Minocycline: Oral extended release minocycline"
10219|NCT02695446|P1|Participant Flow|Oral ER Minocycline - Up to 2mg/kg|"Oral extended release minocycline - up to 2mg/kg once a day for 30 days.~Minocycline: Oral extended release minocycline"
10220|NCT02695446|O1|Outcome|Oral ER Minocycline - Up to 2mg/kg|"Oral extended release minocycline - up to 2mg/kg once a day for 30 days.~Minocycline: Oral extended release minocycline"
10221|NCT02695446|O1|Outcome|Oral ER Minocycline - Up to 2mg/kg|"Oral extended release minocycline - up to 2mg/kg once a day for 30 days.~Minocycline: Oral extended release minocycline"
10222|NCT02695446|E1|Reported Event|Oral ER Minocycline - Up to 2mg/kg|"Oral extended release minocycline - up to 2mg/kg once a day for 30 days.~Minocycline: Oral extended release minocycline"
10223|NCT02695290|B1|Baseline|Afatinib|Subject received Giotrif® / Gilotrif® (Afatinib) with starting dose of 30 milligram (mg) orally, once daily until progression or occurrence of intolerable adverse event (AE) or end of trial.
10224|NCT02695290|P1|Participant Flow|Afatinib|Subject received Giotrif® / Gilotrif® (Afatinib) with starting dose of 30 milligram (mg) orally, once daily until progression or occurrence of intolerable adverse event (AE) or end of trial.
10225|NCT02695290|O1|Outcome|Afatinib|Subject received Giotrif® / Gilotrif® (Afatinib) with starting dose of 30 milligram (mg) orally, once daily until progression or occurrence of intolerable adverse event (AE) or end of trial.
10226|NCT02695290|O1|Outcome|Afatinib|Subject received Giotrif® / Gilotrif® (Afatinib) with starting dose of 30 milligram (mg) orally, once daily until progression or occurrence of intolerable adverse event (AE) or end of trial.
10227|NCT02695290|O1|Outcome|Afatinib|Subject received Giotrif® / Gilotrif® (Afatinib) with starting dose of 30 milligram (mg) orally, once daily until progression or occurrence of intolerable adverse event (AE) or end of trial.
10228|NCT02695290|E1|Reported Event|Afatinib|Subject received Giotrif® / Gilotrif® (Afatinib) with starting dose of 30 milligram (mg) orally, once daily until progression or occurrence of intolerable adverse event (AE) or end of trial.
10229|NCT02694744|B3|Baseline|Total|Total of all reporting groups
10230|NCT02694744|B2|Baseline|Group 2 - Dosing With Food|"Patiromer dosing with food~patiromer: 8.4 g/day starting dose, administered orally~*Note: Two randomized participants in Group 2 -Dosing With Food were excluded from the analyses for the intent-to-treat (ITT) population. One participant who did not receive any patiromer dose. Another participant had an important protocol violation and had no post-baseline serum K+, and was excluded from ITT prior to unblinding."
10231|NCT02694744|B1|Baseline|Group 1 - Dosing Without Food|"Patiromer dosing without food~patiromer: 8.4 g/day starting dose, administered orally"
10232|NCT02694744|P2|Participant Flow|Group 2 - Dosing With Food|"Patiromer dosing with food~patiromer: 8.4 g/day starting dose, administered orally"
10233|NCT02694744|P1|Participant Flow|Group 1 - Dosing Without Food|"Patiromer dosing without food~patiromer: 8.4 g/day starting dose, administered orally"
10234|NCT02694744|O2|Outcome|Group 2|Patiromer with Food
10235|NCT02694744|O1|Outcome|Group 1|Patiromer without Food
10236|NCT02694744|O2|Outcome|Group 2 - Dosing With Food|"Patiromer dosing with food~patiromer: 8.4 g/day starting dose, administered orally"
10237|NCT02694744|O1|Outcome|Group 1 - Dosing Without Food|"Patiromer dosing without food~patiromer: 8.4 g/day starting dose, administered orally"
10238|NCT02694744|E2|Reported Event|Group 2 - Dosing With Food|"Patiromer dosing with food~patiromer: 8.4 g/day starting dose, administered orally~*Note - One randomized participant was excluded from the analysis as this participant did not receive any patiromer dose."
10239|NCT02694744|E1|Reported Event|Group 1 - Dosing Without Food|"Patiromer dosing without food~patiromer: 8.4 g/day starting dose, administered orally"
10240|NCT02694718|B1|Baseline|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
10241|NCT02694718|P1|Participant Flow|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 milligrams per square meter (mg/m^2) on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 twice a day (bid) orally, along with oxaliplatin as a 2-hour intravenous (iv) infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 gray (Gy)/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
10242|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
10243|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
10244|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
10245|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
10246|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
10247|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
10248|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
10249|NCT02694718|E1|Reported Event|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
10250|NCT02694536|B1|Baseline|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
10251|NCT02694536|P1|Participant Flow|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 milligrams (mg) orally (PO) once daily. Gemcitabine was administered as 1000 milligrams per meter-squared (mg/m^2) via intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
10252|NCT02694536|O1|Outcome|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
10253|NCT02694536|O1|Outcome|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
10254|NCT02694536|O1|Outcome|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
10255|NCT02694536|O1|Outcome|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
10348|NCT02692495|E2|Reported Event|Halitosis|individuals self-reporting breath malodors but not body odors
10349|NCT02692495|E1|Reported Event|Body Odor|individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis
10350|NCT02691507|B3|Baseline|Total|Total of all reporting groups
10256|NCT02694536|O1|Outcome|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
10257|NCT02694536|O1|Outcome|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
10258|NCT02694536|E1|Reported Event|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
10259|NCT02694315|B1|Baseline|Induction of Labor|"200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.~Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination~cervical length: measuring cervical length by trans-vaginal ultrasound"
10260|NCT02694315|P1|Participant Flow|Induction of Labor|"200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.~Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination~cervical length: measuring cervical length by trans-vaginal ultrasound"
10261|NCT02694315|O1|Outcome|Induction of Labor|"200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.~Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination~cervical length: measuring cervical length by trans-vaginal ultrasound"
10262|NCT02694315|O1|Outcome|Induction of Labor|"200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.~Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination~cervical length: measuring cervical length by trans-vaginal ultrasound"
10263|NCT02694315|E1|Reported Event|Induction of Labor|"200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.~Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination~cervical length: measuring cervical length by trans-vaginal ultrasound"
10264|NCT02694198|B1|Baseline|Mid-trimester Abortion|The population of the study comprised 135 pregnant women attending Ain Shams University Maternity hospital at labor and delivery ward diagnosed with mid-trimester missed miscarriage confirmed by transabdominal ultrasound who will undergo termination by misoprostol
10265|NCT02694198|P1|Participant Flow|Mid-trimester Abortion|The population of the study comprised 135 pregnant women attending Ain Shams University Maternity hospital at labor and delivery ward diagnosed with mid-trimester missed miscarriage confirmed by transabdominal ultrasound who will undergo termination by misoprostol
10266|NCT02694198|O1|Outcome|Mid-trimester Abortion|The population of the study comprised 135 pregnant women attending Ain Shams University Maternity hospital at labor and delivery ward diagnosed with mid-trimester missed miscarriage confirmed by transabdominal ultrasound who will undergo termination by misoprostol
10267|NCT02694198|O1|Outcome|Mid-trimester Abortion|The population of the study comprised 135 pregnant women attending Ain Shams University Maternity hospital at labor and delivery ward diagnosed with mid-trimester missed miscarriage confirmed by transabdominal ultrasound who will undergo termination by misoprostol
10268|NCT02694198|E1|Reported Event|Mid-trimester Abortion|The population of the study comprised 135 pregnant women attending Ain Shams University Maternity hospital at labor and delivery ward diagnosed with mid-trimester missed miscarriage confirmed by transabdominal ultrasound who will undergo termination by misoprostol
10269|NCT02693704|B5|Baseline|Total|Total of all reporting groups
10270|NCT02693704|B4|Baseline|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
10271|NCT02693704|B3|Baseline|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
10351|NCT02691507|B2|Baseline|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10272|NCT02693704|B2|Baseline|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
10273|NCT02693704|B1|Baseline|Normal Hearing|People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.
10274|NCT02693704|P4|Participant Flow|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
10275|NCT02693704|P3|Participant Flow|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
10276|NCT02693704|P2|Participant Flow|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
10277|NCT02693704|P1|Participant Flow|Normal Hearing|"People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.~Hearing Aids: The only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment."
10278|NCT02693704|O4|Outcome|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
10279|NCT02693704|O3|Outcome|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
10280|NCT02693704|O2|Outcome|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
10281|NCT02693704|O1|Outcome|Normal Hearing|"People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.~Hearing Aids: The only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment."
10282|NCT02693704|O4|Outcome|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
10283|NCT02693704|O3|Outcome|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
10284|NCT02693704|O2|Outcome|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
10285|NCT02693704|O1|Outcome|Normal Hearing|"People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.~Hearing Aids: The only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment."
10286|NCT02693704|O4|Outcome|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
10287|NCT02693704|O3|Outcome|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
10288|NCT02693704|O2|Outcome|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
10289|NCT02693704|O1|Outcome|Normal Hearing|"People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.~Hearing Aids: The only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment."
10290|NCT02693704|E4|Reported Event|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
10291|NCT02693704|E3|Reported Event|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
10292|NCT02693704|E2|Reported Event|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
10352|NCT02691507|B1|Baseline|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10293|NCT02693704|E1|Reported Event|Normal Hearing|"People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.~Hearing Aids: The only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment."
10294|NCT02692859|B3|Baseline|Total|Total of all reporting groups
10295|NCT02692859|B2|Baseline|Vaccine (Walvax Biotechnology Co., LTD.)|"Hib conjugate vaccine~Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 years:one dose(0 d), 0.5ml for each dose"
10296|NCT02692859|B1|Baseline|Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.)|"Hib conjugate vaccine~Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 years:one dose(0 d), 0.5ml for each dose"
10297|NCT02692859|P2|Participant Flow|Vaccine (Walvax Biotechnology Co., LTD.)|"Hib conjugate vaccine~Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 y:one dose(0 d), 0.5ml for each dose"
10298|NCT02692859|P1|Participant Flow|Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.)|"Hib conjugate vaccine~Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 y:one dose(0 d), 0.5ml for each dose"
10299|NCT02692859|O2|Outcome|Vaccine (Walvax Biotechnology Co., LTD.)|"Hib conjugate vaccine~Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 y:one dose(0 d), 0.5ml for each dose"
10300|NCT02692859|O1|Outcome|Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.)|"Hib conjugate vaccine~Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 y:one dose(0 d), 0.5ml for each dose"
10301|NCT02692859|E2|Reported Event|Vaccine (Walvax Biotechnology Co., LTD.)|"Hib conjugate vaccine~Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 y:one dose(0 d), 0.5ml for each dose"
10302|NCT02692859|E1|Reported Event|Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.)|"Hib conjugate vaccine~Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 y:one dose(0 d), 0.5ml for each dose"
10303|NCT02692703|B1|Baseline|Glecaprevir/Pibrentasvir|Glecaprevir/pibrentasvir (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
10304|NCT02692703|P1|Participant Flow|Glecaprevir/Pibrentasvir|Glecaprevir/pibrentasvir (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
10305|NCT02692703|O1|Outcome|Glecaprevir/Pibrentasvir|Glecaprevir/pibrentasvir (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
10306|NCT02692703|O1|Outcome|Glecaprevir/Pibrentasvir|Glecaprevir/pibrentasvir (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
10307|NCT02692703|O1|Outcome|Glecaprevir/Pibrentasvir|Glecaprevir/pibrentasvir (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
10308|NCT02692703|E1|Reported Event|Glecaprevir/Pibrentasvir|Glecaprevir/pibrentasvir (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
10309|NCT02692560|B3|Baseline|Total|Total of all reporting groups
10310|NCT02692560|B2|Baseline|Healthy Living|"Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.~Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees."
10311|NCT02692560|B1|Baseline|I-STAND|"Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.~I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time."
10312|NCT02692560|P2|Participant Flow|Healthy Living|"Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.~Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees."
10313|NCT02692560|P1|Participant Flow|I-STAND|"Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.~I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time."
10314|NCT02692560|O2|Outcome|Healthy Living|"Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.~Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees."
10568|NCT02689206|B6|Baseline|Total|Total of all reporting groups
10315|NCT02692560|O1|Outcome|I-STAND|"Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.~I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time."
10316|NCT02692560|O2|Outcome|Healthy Living|"Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.~Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees."
10317|NCT02692560|O1|Outcome|I-STAND|"Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.~I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time."
10318|NCT02692560|O2|Outcome|Healthy Living|"Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.~Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees."
10319|NCT02692560|O1|Outcome|I-STAND|"Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.~I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time."
10320|NCT02692560|O2|Outcome|Healthy Living|"Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.~Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees."
10321|NCT02692560|O1|Outcome|I-STAND|"Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.~I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time."
10322|NCT02692560|O2|Outcome|Healthy Living|"Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.~Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees."
10323|NCT02692560|O1|Outcome|I-STAND|"Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.~I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time."
10324|NCT02692560|O2|Outcome|Healthy Living|"Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.~Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees."
10325|NCT02692560|O1|Outcome|I-STAND|"Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.~I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time."
10326|NCT02692560|O2|Outcome|Healthy Living|"Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.~Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees."
10327|NCT02692560|O1|Outcome|I-STAND|"Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.~I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time."
10328|NCT02692560|O2|Outcome|Healthy Living|"Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.~Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees."
10329|NCT02692560|O1|Outcome|I-STAND|"Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.~I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time."
10330|NCT02692560|E2|Reported Event|Healthy Living|"Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.~Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees."
10331|NCT02692560|E1|Reported Event|I-STAND|"Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.~I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time."
10332|NCT02692495|B3|Baseline|Total|Total of all reporting groups
10333|NCT02692495|B2|Baseline|Halitosis|individuals with halitosis, not complaining of body odors
10334|NCT02692495|B1|Baseline|Body Odor|individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis
10335|NCT02692495|P2|Participant Flow|Halitosis|individuals with halitosis (bad breath), not complaining of body odors
10336|NCT02692495|P1|Participant Flow|Body Odor|individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis
10337|NCT02692495|O3|Outcome|"Lactic Subgroup"|"Garbage odor identified as one of the most common types of odor"
10338|NCT02692495|O2|Outcome|"Sweet Group"|Self-reported odors mostly identified as gas, benzene, “burning”,“sulfur”, “rotten vegetables”, “rotten eggs”, cheesy/sweaty and sulfury fecal, sewage, “burning”, and elusive odors that could not be smelled by the sufferer including “PATM” condition (odors could not be named, but people near the sufferer exhibited increased displeasure, coughing, sneezing, and rubbing their noses).
10339|NCT02692495|O1|Outcome|"Sour Group"|Self-reported predominant odors included “fishy”, “ammonia”, sour acetone (body odor associated with alcoholism), fecal-diarrheal, and generic “fecal odor”
10340|NCT02692495|O3|Outcome|"Lactic Subgroup"|"Garbage odor identified as one of the most common types of odor"
10341|NCT02692495|O2|Outcome|"Sweet Group"|Self-reported odors mostly identified as gas, benzene, “burning”,“sulfur”, “rotten vegetables”, “rotten eggs”, cheesy/sweaty and sulfury fecal, sewage, “burning”, and elusive odors that could not be smelled by the sufferer including “PATM” condition (odors could not be named, but people near the sufferer exhibited increased displeasure, coughing, sneezing, and rubbing their noses).
10342|NCT02692495|O1|Outcome|"Sour Group"|Self-reported predominant odors included “fishy”, “ammonia”, sour acetone (body odor associated with alcoholism), fecal-diarrheal, and generic “fecal odor”
10343|NCT02692495|O3|Outcome|"Lactic Subgroup"|"Garbage odor identified as one of the most common types of odor (subgroup of the Sour cluster)"
10344|NCT02692495|O2|Outcome|"Sweet Group"|Self-reported odors mostly identified as gas, benzene, “burning”,“sulfur”, “rotten vegetables”, “rotten eggs”, cheesy/sweaty and sulfury fecal, sewage, “burning”, and elusive odors that could not be smelled by the sufferer including “PATM” condition (odors could not be named, but people near the sufferer exhibited increased displeasure, coughing, sneezing, and rubbing their noses).
10345|NCT02692495|O1|Outcome|"Sour Group"|Self-reported predominant odors included “fishy”, “ammonia”, sour acetone (body odor associated with alcoholism), fecal-diarrheal, and generic “fecal odor”
10346|NCT02692495|O2|Outcome|Halitosis|individuals with halitosis, not complaining of body odors
10347|NCT02692495|O1|Outcome|Body Odor|individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis
10353|NCT02691507|P2|Participant Flow|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10354|NCT02691507|P1|Participant Flow|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10355|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10356|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10357|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10358|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10359|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10360|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10361|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10362|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10363|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10364|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10365|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10366|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10367|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10368|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10369|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10370|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10371|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10372|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10373|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10374|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10375|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10376|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10377|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10378|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10379|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10380|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10381|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10382|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10383|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10384|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10385|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10386|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10387|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10388|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10389|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10390|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10391|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10392|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
17725|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
10393|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10394|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10395|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10396|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10397|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10398|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10399|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10400|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10401|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10402|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10403|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10404|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10405|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10406|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10407|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10408|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10409|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10410|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10411|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10412|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10413|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10414|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10415|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10416|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10417|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10418|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10419|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10420|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10421|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10422|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10423|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10424|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10425|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10426|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10427|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10428|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10429|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10430|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10431|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10432|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10663|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10433|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10434|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10435|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10436|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10437|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10438|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10439|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10440|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10441|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10442|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10443|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10444|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10445|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10446|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10447|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10448|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10449|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10450|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10451|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10452|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10453|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10454|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10455|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10456|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10457|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10458|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10459|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10460|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10461|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10462|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10463|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10464|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10465|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10466|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10467|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10468|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10469|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10470|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10471|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10472|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10798|NCT02687126|O1|Outcome|Time to Successful Cannulation|Time taken in seconds from skin prick to aspiration of blood from catheter
10473|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10474|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10475|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10476|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10477|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10478|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10479|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10480|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10481|NCT02691507|E2|Reported Event|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
10482|NCT02691507|E1|Reported Event|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
10483|NCT02691416|B3|Baseline|Total|Total of all reporting groups
10484|NCT02691416|B2|Baseline|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
10485|NCT02691416|B1|Baseline|Propofol Postconditioning|1.2ug/ml propofol Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately.
10486|NCT02691416|P2|Participant Flow|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
10487|NCT02691416|P1|Participant Flow|Propofol Postconditioning|Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately.
10488|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
10489|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/mL propofol~propofol:Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately"
10490|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
10491|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/mL propofol~propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal"
10492|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
10493|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/mL propofol~propofol:Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately"
10494|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
10495|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/ml propofol~propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately."
10496|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
10497|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/ml propofol~propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately."
10498|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
10499|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/mL propofol~propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately"
10500|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
10501|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/mL propofol~propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately."
10502|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
10503|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/ml propofol~propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately."
10504|NCT02691416|E2|Reported Event|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
10505|NCT02691416|E1|Reported Event|Propofol Postconditioning|"1.2ug/mL propofol~propofol:Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately."
10506|NCT02691143|B3|Baseline|Total|Total of all reporting groups
10507|NCT02691143|B2|Baseline|Manipulation Only|The control group received manipulation from a licensed chiropractor only
10508|NCT02691143|B1|Baseline|Manipulation Plus Tape|The Tape Group had TheraBand® Kinesiology Tape, an elastic therapeutic tape (ETT), applied immediately following cervical manipulation from a licensed chiropractor. The taping protocol was applied by the investigator and consist of a “Y” strip applied at 25% tension running superior to inferior from the hair line to T1-2 and a horizontal “I” strip applied at 50% tension at the site of pain.
10509|NCT02691143|P2|Participant Flow|Manipulation Only|The control group received manipulation from a licensed chiropractor only
17726|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
10510|NCT02691143|P1|Participant Flow|Manipulation Plus Tape|The Tape Group had TheraBand® Kinesiology Tape, an elastic therapeutic tape (ETT), applied immediately following cervical manipulation from a licensed chiropractor. The taping protocol was applied by the investigator and consist of a “Y” strip applied at 25% tension running superior to inferior from the hair line to T1-2 and a horizontal “I” strip applied at 50% tension at the site of pain.
10511|NCT02691143|O2|Outcome|Manipulation Only|The control group received manipulation from a licensed chiropractor only
10512|NCT02691143|O1|Outcome|Manipulation Plus Tape|The Tape Group had TheraBand® Kinesiology Tape, an elastic therapeutic tape (ETT), applied immediately following cervical manipulation from a licensed chiropractor. The taping protocol was applied by the investigator and consist of a “Y” strip applied at 25% tension running superior to inferior from the hair line to T1-2 and a horizontal “I” strip applied at 50% tension at the site of pain.
10513|NCT02691143|O2|Outcome|Manipulation Only|The control group received manipulation from a licensed chiropractor only
10514|NCT02691143|O1|Outcome|Manipulation Plus Tape|The Tape Group had TheraBand® Kinesiology Tape, an elastic therapeutic tape (ETT), applied immediately following cervical manipulation from a licensed chiropractor. The taping protocol was applied by the investigator and consist of a “Y” strip applied at 25% tension running superior to inferior from the hair line to T1-2 and a horizontal “I” strip applied at 50% tension at the site of pain.
10515|NCT02691143|E2|Reported Event|Manipulation Only|The control group received manipulation from a licensed chiropractor only
10516|NCT02691143|E1|Reported Event|Manipulation Plus Tape|The Tape Group had TheraBand® Kinesiology Tape, an elastic therapeutic tape (ETT), applied immediately following cervical manipulation from a licensed chiropractor. The taping protocol was applied by the investigator and consist of a “Y” strip applied at 25% tension running superior to inferior from the hair line to T1-2 and a horizontal “I” strip applied at 50% tension at the site of pain.
10517|NCT02690935|B3|Baseline|Total|Total of all reporting groups
10518|NCT02690935|B2|Baseline|Placebo|"Non-impregnated lactose saccharose globules (380 mg/capsule)~Placebo: Placebo"
10519|NCT02690935|B1|Baseline|2LALERG|"Interleukin 1: 17 CH Interleukin 4: 17–27 CH Interleukin 5: 17 CH Interleukin 6: 17 CH Interleukin 10: 17 CH Interleukin 12: 9 CH Interleukin 13: 17 CH Tumor Necrosis Factor Alpha: 17 CH Transforming Growth Factor Beta: 5 CH Pulmo histaminum: 15 CH SNA-HLA-II: 18 CH~Impregnated on lactose saccharose globules (380 mg/capsule)~2LALERG: Homeopathic drug"
10520|NCT02690935|P2|Participant Flow|Placebo|"Non-impregnated lactose saccharose globules (380 mg/capsule)~Placebo: Placebo"
10521|NCT02690935|P1|Participant Flow|2LALERG|"Interleukin 1: 17 CH Interleukin 4: 17–27 CH Interleukin 5: 17 CH Interleukin 6: 17 CH Interleukin 10: 17 CH Interleukin 12: 9 CH Interleukin 13: 17 CH Tumor Necrosis Factor Alpha: 17 CH Transforming Growth Factor Beta: 5 CH Pulmo histaminum: 15 CH SNA-HLA-II: 18 CH~Impregnated on lactose saccharose globules (380 mg/capsule)~2LALERG: Homeopathic drug"
10522|NCT02690935|O2|Outcome|Placebo|"Non-impregnated lactose saccharose globules (380 mg/capsule)~Placebo: Placebo"
10523|NCT02690935|O1|Outcome|2LALERG|"Interleukin 1: 17 CH Interleukin 4: 17–27 CH Interleukin 5: 17 CH Interleukin 6: 17 CH Interleukin 10: 17 CH Interleukin 12: 9 CH Interleukin 13: 17 CH Tumor Necrosis Factor Alpha: 17 CH Transforming Growth Factor Beta: 5 CH Pulmo histaminum: 15 CH SNA-HLA-II: 18 CH~Impregnated on lactose saccharose globules (380 mg/capsule)~2LALERG: Homeopathic drug"
10524|NCT02690935|O2|Outcome|Placebo|"Non-impregnated lactose saccharose globules (380 mg/capsule)~Placebo: Placebo"
10525|NCT02690935|O1|Outcome|2LALERG|"Interleukin 1: 17 CH Interleukin 4: 17–27 CH Interleukin 5: 17 CH Interleukin 6: 17 CH Interleukin 10: 17 CH Interleukin 12: 9 CH Interleukin 13: 17 CH Tumor Necrosis Factor Alpha: 17 CH Transforming Growth Factor Beta: 5 CH Pulmo histaminum: 15 CH SNA-HLA-II: 18 CH~Impregnated on lactose saccharose globules (380 mg/capsule)~2LALERG: Homeopathic drug"
10526|NCT02690935|E2|Reported Event|Placebo|"Non-impregnated lactose saccharose globules (380 mg/capsule)~Placebo: Placebo"
10527|NCT02690935|E1|Reported Event|2LALERG|"Interleukin 1: 17 CH Interleukin 4: 17–27 CH Interleukin 5: 17 CH Interleukin 6: 17 CH Interleukin 10: 17 CH Interleukin 12: 9 CH Interleukin 13: 17 CH Tumor Necrosis Factor Alpha: 17 CH Transforming Growth Factor Beta: 5 CH Pulmo histaminum: 15 CH SNA-HLA-II: 18 CH~Impregnated on lactose saccharose globules (380 mg/capsule)~2LALERG: Homeopathic drug"
10528|NCT02690727|B1|Baseline|All Participants|"A single dose of RP6530 following fasting and Fed condition~RP6530: Single oral dose"
10529|NCT02690727|P2|Participant Flow|RP6530: Fed Condition First, Then Fast Condition|"Fed Condition first, then Fast Condition~RP6530: Single oral dose"
10530|NCT02690727|P1|Participant Flow|RP6530: Fast Condition First, Then Fed Condition|"Fast Condition first, then Fed Condition~RP6530: Single oral dose"
10531|NCT02690727|O2|Outcome|RP6530 in Fed Condition|"A single dose of RP6530 following fed condition~RP6530: Single oral dose"
10532|NCT02690727|O1|Outcome|RP6530 in Fast Condition|"A single dose of RP6530 following fast condition~RP6530: Single oral dose"
10533|NCT02690727|O2|Outcome|RP6530 in Fed Condition|"A single dose of RP6530 following fed Condition~RP6530: Single oral dose"
10534|NCT02690727|O1|Outcome|RP6530 in Fast Condition|"A single dose of RP6530 following fast Condition~RP6530: Single oral dose"
10535|NCT02690727|O2|Outcome|RP6530 in Fed Condition|"A single dose of RP6530 following fed condition~RP6530: Single oral dose"
10536|NCT02690727|O1|Outcome|RP6530 in Fast Condition|"A single dose of RP6530 following fast condition~RP6530: Single oral dose"
10537|NCT02690727|E2|Reported Event|RP6530 in Fed Condition|"A single dose of RP6530 following fed condition~RP6530: Single oral dose"
10538|NCT02690727|E1|Reported Event|RP6530 in Fast Condition|"A single dose of RP6530 following fast condition~RP6530: Single oral dose"
10539|NCT02689804|B3|Baseline|Total|Total of all reporting groups
10540|NCT02689804|B2|Baseline|Obese-BMI|Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs (LNG-EC and UPA-EC will be given in random order).
10541|NCT02689804|B1|Baseline|Normal-BMI|Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs (LNG-EC and UPA-EC will be given in random order).
10907|NCT02684396|O6|Outcome|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
10542|NCT02689804|P2|Participant Flow|Obese-MRI|Women with obese BMI will receive the first emergency contraception (EC) dose and complete pharmacokinetics (PK) assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs Levonorgestrel (LNG-EC) and Ulipristal Acetate (UPA-EC) will be given in random order.
10543|NCT02689804|P1|Participant Flow|Normal-BMI|Women with normal BMI will receive the first emergency contraception (EC) dose and complete pharmacokinetics (PK) assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs Levonorgestrel (LNG-EC) and Ulipristal Acetate (UPA-EC) will be given in random order.
10544|NCT02689804|O2|Outcome|Obese-MRI|Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
10545|NCT02689804|O1|Outcome|Normal-BMI|Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
10546|NCT02689804|O2|Outcome|Obese-MRI|Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
10547|NCT02689804|O1|Outcome|Normal-BMI|Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
10548|NCT02689804|O2|Outcome|Obese-MRI|Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
10549|NCT02689804|O1|Outcome|Normal-BMI|Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
10550|NCT02689804|O2|Outcome|Obese-MRI|Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
10551|NCT02689804|O1|Outcome|Normal-BMI|Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
10552|NCT02689804|O2|Outcome|Obese-MRI|Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
10553|NCT02689804|O1|Outcome|Normal-BMI|Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
10554|NCT02689804|O2|Outcome|Obese-MRI|Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
10555|NCT02689804|O1|Outcome|Normal-BMI|Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
10556|NCT02689804|O2|Outcome|Obese-MRI|Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
10557|NCT02689804|O1|Outcome|Normal-BMI|Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
10558|NCT02689804|O2|Outcome|Obese-BMI|Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
10559|NCT02689804|O1|Outcome|Normal-BMI|Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
10560|NCT02689804|O2|Outcome|Obese-BMI|Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
10561|NCT02689804|O1|Outcome|Normal-BMI|Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
10562|NCT02689804|O2|Outcome|Obese-BMI|Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
10563|NCT02689804|O1|Outcome|Normal-BMI|Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
10564|NCT02689804|E4|Reported Event|Obese-BMI on UPA|Women with obese BMI will receive UPA-EC
10565|NCT02689804|E3|Reported Event|Obese-BMI on LNG|Women with obese BMI will receive LNG-EC
10566|NCT02689804|E2|Reported Event|Normal-BMI on UPA|Women with obese BMI will receive UPA-EC
10567|NCT02689804|E1|Reported Event|Normal-BMI on LNG|Women with normal BMI will receive LNG-EC
10569|NCT02689206|B5|Baseline|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10570|NCT02689206|B4|Baseline|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10571|NCT02689206|B3|Baseline|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10572|NCT02689206|B2|Baseline|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10573|NCT02689206|B1|Baseline|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10574|NCT02689206|P5|Participant Flow|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10575|NCT02689206|P4|Participant Flow|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10576|NCT02689206|P3|Participant Flow|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10577|NCT02689206|P2|Participant Flow|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10578|NCT02689206|P1|Participant Flow|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10579|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10580|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10581|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10582|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10583|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10584|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10585|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10586|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10587|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10588|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10589|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10590|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10591|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10592|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10593|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10594|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10595|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10596|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10597|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10598|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10599|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10600|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10601|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10602|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10603|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10604|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10605|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10606|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10607|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10608|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10609|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10610|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10611|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10612|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10613|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10614|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10615|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
20054|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
10616|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10617|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10618|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10619|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10620|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10621|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10622|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10623|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10624|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10625|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10626|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10627|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10628|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10629|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10630|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10631|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10632|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10633|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10634|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10635|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10636|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10637|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10638|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10639|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10640|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10641|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10642|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10643|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10644|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10645|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10646|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10647|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10648|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10649|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10650|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10651|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10652|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10653|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10654|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10655|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10656|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10657|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10658|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10659|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10660|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10661|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10662|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10908|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
10664|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10665|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10666|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10667|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10668|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10669|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10670|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10671|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10672|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10673|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10674|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10675|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10676|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10677|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10678|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10679|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10680|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10681|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10682|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10683|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10684|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10685|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10686|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10687|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10688|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10689|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10690|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10691|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10692|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10693|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10694|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10695|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10696|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10697|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10698|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10699|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10700|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10701|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10702|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10703|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10704|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10705|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10706|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10707|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10708|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10709|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10710|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10909|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
10711|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10712|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10713|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10714|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10715|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10716|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10717|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10718|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10719|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10720|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10721|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10722|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10723|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10724|NCT02689206|O4|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10725|NCT02689206|O3|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10726|NCT02689206|O2|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10727|NCT02689206|O1|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10728|NCT02689206|O4|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10729|NCT02689206|O3|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10730|NCT02689206|O2|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10731|NCT02689206|O1|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10732|NCT02689206|O4|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10733|NCT02689206|O3|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10734|NCT02689206|O2|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10735|NCT02689206|O1|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10736|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10737|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10738|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10739|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10740|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10741|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10742|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10743|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10744|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10745|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10746|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10747|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10748|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10749|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10750|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10751|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10752|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10753|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10754|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10755|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10756|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10757|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10910|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
10758|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10759|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10760|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10761|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10762|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10763|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10764|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10765|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10766|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10767|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10768|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10769|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10770|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10771|NCT02689206|O5|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10772|NCT02689206|O4|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10773|NCT02689206|O3|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10774|NCT02689206|O2|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10775|NCT02689206|O1|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10776|NCT02689206|E5|Reported Event|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
10777|NCT02689206|E4|Reported Event|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
10778|NCT02689206|E3|Reported Event|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
10779|NCT02689206|E2|Reported Event|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
10780|NCT02689206|E1|Reported Event|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
10781|NCT02687217|B3|Baseline|Total|Total of all reporting groups
10782|NCT02687217|B2|Baseline|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.~oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
10783|NCT02687217|B1|Baseline|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
10784|NCT02687217|P2|Participant Flow|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.~oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
10785|NCT02687217|P1|Participant Flow|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
10786|NCT02687217|O2|Outcome|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.~oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
10787|NCT02687217|O1|Outcome|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
10788|NCT02687217|O2|Outcome|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.~oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
10789|NCT02687217|O1|Outcome|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
10790|NCT02687217|O2|Outcome|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.~oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
10791|NCT02687217|O1|Outcome|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
10792|NCT02687217|E2|Reported Event|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.~oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
10793|NCT02687217|E1|Reported Event|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
10794|NCT02687126|B1|Baseline|Demographic Variables|gender, age, weight, height, cross sectional area, body surface area
10795|NCT02687126|P1|Participant Flow|Ultrasound Guided Central Venous Catheterization|Six month study of ultrasound guided internal jugular venous catheterization in pediatric cardiac surgical patients
10796|NCT02687126|O1|Outcome|Correlation|Correlation of cross sectional area of internal jugular vein with number of attempts, time taken for successful cannulation and complication rate
10797|NCT02687126|O1|Outcome|Number of Complications|Complications were defined as arterial puncture, hemothorax, pneumothorax and local site hematoma
10799|NCT02687126|O1|Outcome|Number of Attempts|An attempt is considered unsuccessful if complete withdrawal of the puncture needle out of skin occurs
10800|NCT02687126|E1|Reported Event|Number of Complications|Complications were defined as arterial puncture, hemothorax, pneumothorax and local site hematoma
10801|NCT02686437|B3|Baseline|Total|Total of all reporting groups
10802|NCT02686437|B2|Baseline|Control Tension|"The kinesiology tape will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The clinician applied the tape in an “I” strip from the vertebral border of the scapula to the greater tuberosity of the humerus. Over the course of the 4 weeks of care, the tension of the Control Group’s tape will remain at 0% tension~TheraBand Kinesiology Tape: Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment."
10803|NCT02686437|B1|Baseline|Increasing Tension|"The kinesiology tape will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The clinician applied the tape in an “I” strip from the vertebral border of the scapula to the lesser tubercle of the humerus. Over the course of the 4 weeks of care, the tension of the Intervention Group’s tape will systemically increase based on the following timelines:~Week 1: 0% tension Week 2: 25% tension Week 3: 50% tension Week 4: 75% tension~TheraBand Kinesiology Tape: Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment."
10804|NCT02686437|P2|Participant Flow|Control Tension|"The kinesiology tape will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The clinician applied the tape in an “I” strip from the vertebral border of the scapula to the greater tuberosity of the humerus. Over the course of the 4 weeks of care, the tension of the Control Group’s tape will remain at 0% tension~TheraBand Kinesiology Tape: Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment."
10805|NCT02686437|P1|Participant Flow|Increasing Tension|"The kinesiology tape will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The clinician applied the tape in an “I” strip from the vertebral border of the scapula to the lesser tubercle of the humerus. Over the course of the 4 weeks of care, the tension of the Intervention Group’s tape will systemically increase based on the following timelines:~Week 1: 0% tension Week 2: 25% tension Week 3: 50% tension Week 4: 75% tension~TheraBand Kinesiology Tape: Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment."
10806|NCT02686437|O2|Outcome|Control Tension|"The kinesiology tape will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The clinician applied the tape in an “I” strip from the vertebral border of the scapula to the greater tuberosity of the humerus. Over the course of the 4 weeks of care, the tension of the Control Group’s tape will remain at 0% tension~TheraBand Kinesiology Tape: Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment."
10807|NCT02686437|O1|Outcome|Increasing Tension|"The kinesiology tape will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The clinician applied the tape in an “I” strip from the vertebral border of the scapula to the lesser tubercle of the humerus. Over the course of the 4 weeks of care, the tension of the Intervention Group’s tape will systemically increase based on the following timelines:~Week 1: 0% tension Week 2: 25% tension Week 3: 50% tension Week 4: 75% tension~TheraBand Kinesiology Tape: Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment."
10808|NCT02686437|O2|Outcome|Control Tension|"The kinesiology tape will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The clinician applied the tape in an “I” strip from the vertebral border of the scapula to the greater tuberosity of the humerus. Over the course of the 4 weeks of care, the tension of the Control Group’s tape will remain at 0% tension~TheraBand Kinesiology Tape: Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment."
10809|NCT02686437|O1|Outcome|Increasing Tension|"The kinesiology tape will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The clinician applied the tape in an “I” strip from the vertebral border of the scapula to the lesser tubercle of the humerus. Over the course of the 4 weeks of care, the tension of the Intervention Group’s tape will systemically increase based on the following timelines:~Week 1: 0% tension Week 2: 25% tension Week 3: 50% tension Week 4: 75% tension~TheraBand Kinesiology Tape: Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment."
10827|NCT02685488|E2|Reported Event|Transcranial Ultrasound Sham|"Stimulation with the transcranial ultrasound will be on sham mode. Unknown to both participants and experimenters, the ultrasound will not stimulate.~Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz."
10911|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
10810|NCT02686437|E2|Reported Event|Control Tension|"The kinesiology tape will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The clinician applied the tape in an “I” strip from the vertebral border of the scapula to the greater tuberosity of the humerus. Over the course of the 4 weeks of care, the tension of the Control Group’s tape will remain at 0% tension~TheraBand Kinesiology Tape: Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment."
10811|NCT02686437|E1|Reported Event|Increasing Tension|"The kinesiology tape will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The clinician applied the tape in an “I” strip from the vertebral border of the scapula to the lesser tubercle of the humerus. Over the course of the 4 weeks of care, the tension of the Intervention Group’s tape will systemically increase based on the following timelines:~Week 1: 0% tension Week 2: 25% tension Week 3: 50% tension Week 4: 75% tension~TheraBand Kinesiology Tape: Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment."
10812|NCT02685488|B3|Baseline|Total|Total of all reporting groups
10813|NCT02685488|B2|Baseline|Transcranial Ultrasound Sham|"Stimulation with the transcranial ultrasound will be on sham mode. Unknown to both participants and experimenters, the ultrasound will not stimulate.~Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz."
10814|NCT02685488|B1|Baseline|Transcranial Ultrasound|"Active stimulation with the transcranial ultrasound at 500 kHz with a duty cycle of 0.24 and pulse repetition frequency of 40 Hz.~Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz."
10815|NCT02685488|P2|Participant Flow|Transcranial Ultrasound Sham|"Stimulation with the transcranial ultrasound will be on sham mode. Unknown to both participants and experimenters, the ultrasound will not stimulate.~Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz."
10816|NCT02685488|P1|Participant Flow|Transcranial Ultrasound|"Active stimulation with the transcranial ultrasound at 500 kHz with a duty cycle of 0.24 and pulse repetition frequency of 40 Hz.~Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz."
10817|NCT02685488|O2|Outcome|Transcranial Ultrasound Sham|"Stimulation with the transcranial ultrasound will be on sham mode. Unknown to both participants and experimenters, the ultrasound will not stimulate.~Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz."
10818|NCT02685488|O1|Outcome|Transcranial Ultrasound|"Active stimulation with the transcranial ultrasound at 500 kHz with a duty cycle of 0.24 and pulse repetition frequency of 40 Hz.~Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz."
10819|NCT02685488|O2|Outcome|Transcranial Ultrasound Sham|"Stimulation with the transcranial ultrasound will be on sham mode. Unknown to both participants and experimenters, the ultrasound will not stimulate.~Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz."
10820|NCT02685488|O1|Outcome|Transcranial Ultrasound|"Active stimulation with the transcranial ultrasound at 500 kHz with a duty cycle of 0.24 and pulse repetition frequency of 40 Hz.~Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz."
10821|NCT02685488|O2|Outcome|Transcranial Ultrasound Sham|"Stimulation with the transcranial ultrasound will be on sham mode. Unknown to both participants and experimenters, the ultrasound will not stimulate.~Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz."
10822|NCT02685488|O1|Outcome|Transcranial Ultrasound|"Active stimulation with the transcranial ultrasound at 500 kHz with a duty cycle of 0.24 and pulse repetition frequency of 40 Hz.~Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz."
10823|NCT02685488|O2|Outcome|Transcranial Ultrasound Sham|"Stimulation with the transcranial ultrasound will be on sham mode. Unknown to both participants and experimenters, the ultrasound will not stimulate.~Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz."
10824|NCT02685488|O1|Outcome|Transcranial Ultrasound|"Active stimulation with the transcranial ultrasound at 500 kHz with a duty cycle of 0.24 and pulse repetition frequency of 40 Hz.~Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz."
10825|NCT02685488|O2|Outcome|Transcranial Ultrasound Sham|"Stimulation with the transcranial ultrasound will be on sham mode. Unknown to both participants and experimenters, the ultrasound will not stimulate.~Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz."
10826|NCT02685488|O1|Outcome|Transcranial Ultrasound|"Active stimulation with the transcranial ultrasound at 500 kHz with a duty cycle of 0.24 and pulse repetition frequency of 40 Hz.~Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz."
10906|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
10828|NCT02685488|E1|Reported Event|Transcranial Ultrasound|"Active stimulation with the transcranial ultrasound at 500 kHz with a duty cycle of 0.24 and pulse repetition frequency of 40 Hz.~Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz."
10829|NCT02685202|B1|Baseline|Mandibular Advancement Splint|"An oral appliance which is standard of care in treating mild or moderate obstructive sleep apnea by repositioning the mandible in a forward position~Mandibular advancement splint: A mandibular advancement splint (MAS), functions by comfortably positioning the patient’s mandibular in a forward position, clearing the obstructed airway during sleep."
10830|NCT02685202|P1|Participant Flow|Mandibular Advancement Splint|"An oral appliance which is standard of care in treating mild or moderate obstructive sleep apnea by repositioning the mandible in a forward position~Mandibular advancement splint: A mandibular advancement splint (MAS), functions by comfortably positioning the patient’s mandibular in a forward position, clearing the obstructed airway during sleep."
10831|NCT02685202|O1|Outcome|Mandibular Advancement Splint|"An oral appliance which is standard of care in treating mild or moderate obstructive sleep apnea by repositioning the mandible in a forward position~Mandibular advancement splint: A mandibular advancement splint (MAS), functions by comfortably positioning the patient’s mandibular in a forward position, clearing the obstructed airway during sleep."
10832|NCT02685202|O1|Outcome|Mandibular Advancement Splint|"An oral appliance which is standard of care in treating mild or moderate obstructive sleep apnea by repositioning the mandible in a forward position~Mandibular advancement splint: A mandibular advancement splint (MAS), functions by comfortably positioning the patient’s mandibular in a forward position, clearing the obstructed airway during sleep."
10833|NCT02685202|O1|Outcome|Mandibular Advancement Splint|"An oral appliance which is standard of care in treating mild or moderate obstructive sleep apnea by repositioning the mandible in a forward position~Mandibular advancement splint: A mandibular advancement splint (MAS), functions by comfortably positioning the patient’s mandibular in a forward position, clearing the obstructed airway during sleep."
10834|NCT02685202|E1|Reported Event|Mandibular Advancement Splint|"An oral appliance which is standard of care in treating mild or moderate obstructive sleep apnea by repositioning the mandible in a forward position~Mandibular advancement splint: A mandibular advancement splint (MAS), functions by comfortably positioning the patient’s mandibular in a forward position, clearing the obstructed airway during sleep."
10835|NCT02684942|B1|Baseline|All Participants|All participants who enrolled to this study.
10836|NCT02684942|P6|Participant Flow|Fentanyl,Meperidine,Meperidine,Fentanyl|"First and Fourth Intervention inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.~Second and Third Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4."
10837|NCT02684942|P5|Participant Flow|Meperidine,Fentanyl,Fentanyl,Meperidine|"First and Fourth Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.~Second and Third Intervention inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4."
10838|NCT02684942|P4|Participant Flow|Fentanyl,Fentanyl,Meperidine,Meperidine|"First and Second Intervention inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.~Third and Fourth Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4."
10839|NCT02684942|P3|Participant Flow|Meperidine,Meperidine,Fentanyl,Fentanyl|"First and Second Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.~Third and Fourth Intervention inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4."
10840|NCT02684942|P2|Participant Flow|Fentanyl,Meperidine,Fentanyl,Meperidine|"First and Third Intervention inject inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.~Second and Fourth Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4."
10841|NCT02684942|P1|Participant Flow|Meperidine,Fentanyl,Meperidine,Fentanyl|"First and Third Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.~Second and Fourth Intervention inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4."
10842|NCT02684942|O1|Outcome|Fentanyl|Analyze in fentanyl group.
10843|NCT02684942|O1|Outcome|Meperidine|Analyze in meperidine group.
10844|NCT02684942|O2|Outcome|Fentanyl|Separate analyze in fraction that patient received fentanyl.
10845|NCT02684942|O1|Outcome|Meperidine|Separate analyze in fraction that patient receive meperidine.
10846|NCT02684942|O2|Outcome|Fentanyl|Analyze in fentanyl group.
10847|NCT02684942|O1|Outcome|Meperidine|Analyze in meperidine group.
10848|NCT02684942|O2|Outcome|Fentanyl|Separate analyze in fraction that patient received fentanyl.
10849|NCT02684942|O1|Outcome|Meperidine|Separate analyze in fraction that patient receive meperidine.
10850|NCT02684942|O2|Outcome|Fentanyl|Separate analysis in fentanyl group.
10851|NCT02684942|O1|Outcome|Meperidine|Separate analysis in meperidine group.
10852|NCT02684942|E2|Reported Event|Fentanyl|Analyze in fentanyl group.
10853|NCT02684942|E1|Reported Event|Meperidine|Analyze in meperidine group.
10854|NCT02684630|B3|Baseline|Total|Total of all reporting groups
10855|NCT02684630|B2|Baseline|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System.~Trima Accel System: Platelet Apheresis Procedure"
10856|NCT02684630|B1|Baseline|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System.~Trima Accel System: Platelet Apheresis Procedure"
10857|NCT02684630|P2|Participant Flow|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System.~Trima Accel System: Platelet Apheresis Procedure"
10858|NCT02684630|P1|Participant Flow|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System.~Trima Accel System: Platelet Apheresis Procedure"
10859|NCT02684630|O2|Outcome|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System.~Trima Accel System: Platelet Apheresis Procedure"
10860|NCT02684630|O1|Outcome|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System.~Trima Accel System: Platelet Apheresis Procedure"
10861|NCT02684630|O2|Outcome|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).~Trima Accel System: Platelet Apheresis Procedure"
10862|NCT02684630|O1|Outcome|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).~Trima Accel System: Platelet Apheresis Procedure"
10863|NCT02684630|E2|Reported Event|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).~Trima Accel System: Platelet Apheresis Procedure"
10864|NCT02684630|E1|Reported Event|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).~Trima Accel System: Platelet Apheresis Procedure"
10865|NCT02684604|B3|Baseline|Total|Total of all reporting groups
10866|NCT02684604|B2|Baseline|Fertile Women|44 fertile women
10867|NCT02684604|B1|Baseline|Unexplained Infertility Patients|44 patients diagnosed to have unexplained infertility
10868|NCT02684604|P2|Participant Flow|Fertile Women|44 fertile women
10869|NCT02684604|P1|Participant Flow|Unexplained Infertility Patients|44 patients diagnosed to have unexplained infertility
10870|NCT02684604|O2|Outcome|Fertile Women|44 fertile women
10871|NCT02684604|O1|Outcome|Unexplained Infertility Patients|44 patients diagnosed to have unexplained infertility
10872|NCT02684604|E2|Reported Event|Fertile Women|44 fertile women
10873|NCT02684604|E1|Reported Event|Unexplained Infertility Patients|44 patients diagnosed to have unexplained infertility
10874|NCT02684396|B7|Baseline|Total|Total of all reporting groups
10875|NCT02684396|B6|Baseline|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
10876|NCT02684396|B5|Baseline|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
10877|NCT02684396|B4|Baseline|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
10878|NCT02684396|B3|Baseline|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
10879|NCT02684396|B2|Baseline|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
10880|NCT02684396|B1|Baseline|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
10881|NCT02684396|P6|Participant Flow|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
10882|NCT02684396|P5|Participant Flow|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
10883|NCT02684396|P4|Participant Flow|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
10884|NCT02684396|P3|Participant Flow|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
10885|NCT02684396|P2|Participant Flow|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
10886|NCT02684396|P1|Participant Flow|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
10887|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
10888|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
10889|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
10890|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
10891|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
10892|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
10893|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
10894|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
10895|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
10896|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
10897|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
10898|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
10899|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
10900|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
10901|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
10902|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
10903|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
10904|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
10905|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
10913|NCT02684396|O6|Outcome|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
10914|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
10915|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
10916|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
10917|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
10918|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
10919|NCT02684396|O6|Outcome|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
10920|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
10921|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
10922|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
10923|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
10924|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
10925|NCT02684396|O6|Outcome|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
10926|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
10927|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
10928|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
10929|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
10930|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
10931|NCT02684396|E6|Reported Event|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
10932|NCT02684396|E5|Reported Event|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
10933|NCT02684396|E4|Reported Event|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
10934|NCT02684396|E3|Reported Event|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
10935|NCT02684396|E2|Reported Event|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
10936|NCT02684396|E1|Reported Event|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
10937|NCT02684188|B3|Baseline|Total|Total of all reporting groups
10938|NCT02684188|B2|Baseline|Enhanced Transitions Planning|"The intervention consists of a package of procedures that enhances supports during the transitions from the hospital to recovery at home, including a structured needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs and the provision of recovery supports to the patient.~Enhanced Transitions Planning: While in the treating hospital, patients from small towns and rural communities are engaged in package of procedures designed to improve the transitions home, including a functional needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs and the provision of enhanced recovery supports to the patient."
10939|NCT02684188|B1|Baseline|Current Treatment|Patients receive that current discharge planning services and supports.
10940|NCT02684188|P2|Participant Flow|Enhanced Discharge Planning and Rural Transition Supports|"The intervention consists of a package of procedures that enhances supports during the transitions from the hospital to recovery at home, including a structured needs assessment that produces a plan that matches available rural community service providers to a patient's transition needs and the provision of recovery supports to the patient.~Enhanced Transitions Planning: While in the treating hospital, patients from small towns and rural communities are engaged in a process designed to improve the transitions home, including a functional needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs. Once home, a Local Community Transition Coordinator provides support to address needs."
10941|NCT02684188|P1|Participant Flow|Standard Hospital Discharge Planning Services|Patients receive standard discharge planning services.
10942|NCT02684188|O2|Outcome|Enhanced Discharge Planning and Rural Transition Supports|"The intervention consists of a package of procedures that enhances supports during the transitions from the hospital to recovery at home, including a structured needs assessment that produces a plan that matches available rural community service providers to a patient's transition needs and the provision of recovery supports to the patient.~Enhanced Transitions Planning: While in the treating hospital, patients from small towns and rural communities are engaged in a process designed to improve the transitions home, including a functional needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs. Once home, a Local Community Transition Coordinator provides support to address needs."
10943|NCT02684188|O1|Outcome|Standard Hospital Discharge Planning Services|Patients receive standard discharge planning services.
10944|NCT02684188|O2|Outcome|Enhanced Discharge Planning and Rural Transition Supports|"The intervention consists of a package of procedures that enhances supports during the transitions from the hospital to recovery at home, including a structured needs assessment that produces a plan that matches available rural community service providers to a patient's transition needs and the provision of recovery supports to the patient.~Enhanced Transitions Planning: While in the treating hospital, patients from small towns and rural communities are engaged in a process designed to improve the transitions home, including a functional needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs. Once home, a Local Community Transition Coordinator provides support to address needs."
10945|NCT02684188|O1|Outcome|Standard Hospital Discharge Planning Services|Patients receive standard discharge planning services.
10981|NCT02683746|O1|Outcome|Albiglutide Liquid|Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
11243|NCT02675907|O1|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
20055|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
10946|NCT02684188|O2|Outcome|Enhanced Discharge Planning and Rural Transition Supports|"The intervention consists of a package of procedures that enhances supports during the transitions from the hospital to recovery at home, including a structured needs assessment that produces a plan that matches available rural community service providers to a patient's transition needs and the provision of recovery supports to the patient.~Enhanced Transitions Planning: While in the treating hospital, patients from small towns and rural communities are engaged in a process designed to improve the transitions home, including a functional needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs. Once home, a Local Community Transition Coordinator provides support to address needs."
10947|NCT02684188|O1|Outcome|Standard Hospital Discharge Planning Services|Patients receive standard discharge planning services.
10948|NCT02684188|O2|Outcome|Enhanced Discharge Planning and Rural Transition Supports|"The intervention consists of a package of procedures that enhances supports during the transitions from the hospital to recovery at home, including a structured needs assessment that produces a plan that matches available rural community service providers to a patient's transition needs and the provision of recovery supports to the patient.~Enhanced Transitions Planning: While in the treating hospital, patients from small towns and rural communities are engaged in a process designed to improve the transitions home, including a functional needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs. Once home, a Local Community Transition Coordinator provides support to address needs."
10949|NCT02684188|O1|Outcome|Standard Hospital Discharge Planning Services|Patients receive standard discharge planning services.
10950|NCT02684188|O2|Outcome|Enhanced Discharge Planning and Rural Transition Supports|"The intervention consists of a package of procedures that enhances supports during the transitions from the hospital to recovery at home, including a structured needs assessment that produces a plan that matches available rural community service providers to a patient's transition needs and the provision of recovery supports to the patient.~Enhanced Transitions Planning: While in the treating hospital, patients from small towns and rural communities are engaged in a process designed to improve the transitions home, including a functional needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs. Once home, a Local Community Transition Coordinator provides support to address needs."
10951|NCT02684188|O1|Outcome|Standard Hospital Discharge Planning Services|Patients receive standard discharge planning services.
10952|NCT02684188|O2|Outcome|Enhanced Discharge Planning and Rural Transition Supports|"The intervention consists of a package of procedures that enhances supports during the transitions from the hospital to recovery at home, including a structured needs assessment that produces a plan that matches available rural community service providers to a patient's transition needs and the provision of recovery supports to the patient.~Enhanced Transitions Planning: While in the treating hospital, patients from small towns and rural communities are engaged in a process designed to improve the transitions home, including a functional needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs. Once home, a Local Community Transition Coordinator provides support to address needs."
10953|NCT02684188|O1|Outcome|Standard Hospital Discharge Planning Services|Patients receive standard discharge planning services.
10954|NCT02684188|O2|Outcome|Enhanced Discharge Planning and Rural Transition Supports|"The intervention consists of a package of procedures that enhances supports during the transitions from the hospital to recovery at home, including a structured needs assessment that produces a plan that matches available rural community service providers to a patient's transition needs and the provision of recovery supports to the patient.~Enhanced Transitions Planning: While in the treating hospital, patients from small towns and rural communities are engaged in a process designed to improve the transitions home, including a functional needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs. Once home, a Local Community Transition Coordinator provides support to address needs."
10955|NCT02684188|O1|Outcome|Standard Hospital Discharge Planning Services|Patients receive standard discharge planning services;the baseline and return to baseline groups were combined to form a single standard discharge group
10956|NCT02684188|O2|Outcome|Enhanced Discharge Planning and Rural Transition Supports|"The intervention consists of a package of procedures that enhances supports during the transitions from the hospital to recovery at home, including a structured needs assessment that produces a plan that matches available rural community service providers to a patient's transition needs and the provision of recovery supports to the patient.~Enhanced Transitions Planning: While in the treating hospital, patients from small towns and rural communities are engaged in a process designed to improve the transitions home, including a functional needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs. Once home, a Local Community Transition Coordinator provides support to address needs."
10957|NCT02684188|O1|Outcome|Standard Hospital Discharge Planning Services|Patients receive standard discharge planning services;the baseline and return to baseline groups were combined to form a single standard discharge group
10958|NCT02684188|O2|Outcome|Enhanced Discharge & Rural Transition Support|"The intervention consists of a package of procedures that enhances supports during the transitions from the hospital to recovery at home, including a structured needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs and the provision of recovery supports to the patient.~Enhanced Discharge Planning & Rural Transition Support: While in the treating hospital, patients from small towns and rural communities are engaged in package of procedures designed to improve the transitions home, including a functional needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs and the provision of enhanced recovery supports to the patient."
10959|NCT02684188|O1|Outcome|Standard Hospital Discharge Services|Patients received standard discharge planning; the baseline and return to baseline groups were combined to form a single standard discharge group
10982|NCT02683746|O2|Outcome|Albiglutide Lyophilized|Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
11244|NCT02675907|O2|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
10960|NCT02684188|O2|Outcome|Enhanced Discharge & Rural Transition Support|"The intervention consists of a package of procedures that enhances supports during the transitions from the hospital to recovery at home, including a structured needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs and the provision of recovery supports to the patient.~Enhanced Discharge Planning & Rural Transition Support: While in the treating hospital, patients from small towns and rural communities are engaged in package of procedures designed to improve the transitions home, including a functional needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs and the provision of enhanced recovery supports to the patient."
10961|NCT02684188|O1|Outcome|Standard Hospital Discharge Services|Patients received standard discharge planning; the baseline and return to baseline groups were combined to form a single standard discharge group
10962|NCT02684188|E2|Reported Event|Enhanced Discharge Planning and Rural Transition Supports|"The intervention consists of a package of procedures that enhances supports during the transitions from the hospital to recovery at home, including a structured needs assessment that produces a plan that matches available rural community service providers to a patient's transition needs and the provision of recovery supports to the patient.~Enhanced Transitions Planning: While in the treating hospital, patients from small towns and rural communities are engaged in a process designed to improve the transitions home, including a functional needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs. Once home, a Local Community Transition Coordinator provides support to address needs."
10963|NCT02684188|E1|Reported Event|Standard Hospital Discharge Planning Services|Patients receive standard discharge planning services.
10964|NCT02683954|B3|Baseline|Total|Total of all reporting groups
10965|NCT02683954|B2|Baseline|Control|30 women without any laparoscopically detected pelvic endometriotic pathology. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
10966|NCT02683954|B1|Baseline|Endometriosis|30 women with laparoscopically diagnosed endometriosis. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
10967|NCT02683954|P2|Participant Flow|Control|30 women without any laparoscopically detected pelvic endometriotic pathology. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
10968|NCT02683954|P1|Participant Flow|Endometriosis|30 women with laparoscopically diagnosed endometriosis. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
10969|NCT02683954|O2|Outcome|Control|30 women without any laparoscopically detected pelvic endometriotic pathology. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
10970|NCT02683954|O1|Outcome|Endometriosis|30 women with laparoscopically diagnosed endometriosis. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
10971|NCT02683954|E2|Reported Event|Control|30 women without any laparoscopically detected pelvic endometriotic pathology. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
10972|NCT02683954|E1|Reported Event|Endometriosis|30 women with laparoscopically diagnosed endometriosis. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
10973|NCT02683746|B3|Baseline|Total|Total of all reporting groups
10974|NCT02683746|B2|Baseline|Albiglutide Lyophilized|Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
10975|NCT02683746|B1|Baseline|Albiglutide Liquid|Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
10976|NCT02683746|P2|Participant Flow|Albiglutide Lyophilized|Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
10977|NCT02683746|P1|Participant Flow|Albiglutide Liquid|Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
10978|NCT02683746|O2|Outcome|Albiglutide Lyophilized|Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
10979|NCT02683746|O1|Outcome|Albiglutide Liquid|Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
10980|NCT02683746|O2|Outcome|Albiglutide Lyophilized|Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
11245|NCT02675907|O1|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
10983|NCT02683746|O1|Outcome|Albiglutide Liquid|Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
10984|NCT02683746|O2|Outcome|Albiglutide Lyophilized|Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
10985|NCT02683746|O1|Outcome|Albiglutide Liquid|Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
10986|NCT02683746|O2|Outcome|Albiglutide Lyophilized|Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
10987|NCT02683746|O1|Outcome|Albiglutide Liquid|Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
10988|NCT02683746|O2|Outcome|Albiglutide Lyophilized|Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
10989|NCT02683746|O1|Outcome|Albiglutide Liquid|Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
10990|NCT02683746|O2|Outcome|Albiglutide Lyophilized|Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
10991|NCT02683746|O1|Outcome|Albiglutide Liquid|Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
10992|NCT02683746|O2|Outcome|Albiglutide Lyophilized|Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
10993|NCT02683746|O1|Outcome|Albiglutide Liquid|Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
10994|NCT02683746|O2|Outcome|Albiglutide Lyophilized|Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
10995|NCT02683746|O1|Outcome|Albiglutide Liquid|Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
10996|NCT02683746|O2|Outcome|Albiglutide Lyophilized|Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
10997|NCT02683746|O1|Outcome|Albiglutide Liquid|Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
10998|NCT02683746|O2|Outcome|Albiglutide Lyophilized|Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
10999|NCT02683746|O1|Outcome|Albiglutide Liquid|Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
11000|NCT02683746|O2|Outcome|Albiglutide Lyophilized|Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
11001|NCT02683746|O1|Outcome|Albiglutide Liquid|Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
11002|NCT02683746|E2|Reported Event|Albiglutide Lyophilized DCC PI Plus Placebo LAI|Subjects will receive 30mg of albiglutide lyophilized drug product via DCC pen injector and matching placebo via auto injector for 4 weeks. The dose will then be up-titrated to 50mg albiglutide for the remaining 22 weeks of the study. The study treatment will be administered once weekly by subcutaneous injection in the abdomen, thigh, or upper arm.
11003|NCT02683746|E1|Reported Event|Albiglutide Active LAI Plus Placebo Lyophilized DCC PI|Subjects will receive 30 milligrams (mg) of albiglutide liquid drug product via auto injector and matching placebo via lyophilized DCC pen injector for 4 weeks. The dose will then be up-titrated to 50mg albiglutide for the remaining 22 weeks of the study. The study treatment will be administered once weekly by subcutaneous injection in the abdomen, thigh, or upper arm.
11004|NCT02683707|B3|Baseline|Total|Total of all reporting groups
11005|NCT02683707|B2|Baseline|PCI With IV Opiate|"IV midazolam and Local Anesthetic and IV fentanyl for peri-procedural analgesia~Fentanyl: IV peri-procedural analgesia~Lidocaine: Local Anesthetic~Midazolam: IV sedation"
11006|NCT02683707|B1|Baseline|PCI Without IV Opiate|"IV midazolam and Local Anesthetic, with removal of IV fentanyl from peri-procedural analgesia (which is otherwise routinely given)~Removal of Fentanyl from peri-procedural analgesia: Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for PCI)~Lidocaine: Local Anesthetic~Midazolam: IV sedation"
11007|NCT02683707|P2|Participant Flow|PCI With IV Opiate|"IV midazolam and Local Anesthetic and IV fentanyl for peri-procedural analgesia~Fentanyl: IV peri-procedural analgesia~Lidocaine: Local Anesthetic~Midazolam: IV sedation"
11008|NCT02683707|P1|Participant Flow|PCI Without Intranvenous (IV) Opiate|"IV midazolam and Local Anesthetic, with removal of IV fentanyl from peri-procedural analgesia (which is otherwise routinely given)~Removal of Fentanyl from peri-procedural analgesia: Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for percutaneous coronary intervention [PCI])~Lidocaine: Local Anesthetic~Midazolam: IV sedation"
11009|NCT02683707|O2|Outcome|PCI With IV Opiate|"IV midazolam and Local Anesthetic and IV fentanyl for peri-procedural analgesia~Fentanyl: IV peri-procedural analgesia~Lidocaine: Local Anesthetic~Midazolam: IV sedation"
11010|NCT02683707|O1|Outcome|PCI Without IV Opiate|"IV midazolam and Local Anesthetic, with removal of IV fentanyl from peri-procedural analgesia (which is otherwise routinely given)~Removal of Fentanyl from peri-procedural analgesia: Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for PCI)~Lidocaine: Local Anesthetic~Midazolam: IV sedation"
11011|NCT02683707|O2|Outcome|PCI With IV Opiate|"IV midazolam and Local Anesthetic and IV fentanyl for peri-procedural analgesia~Fentanyl: IV peri-procedural analgesia~Lidocaine: Local Anesthetic~Midazolam: IV sedation"
11012|NCT02683707|O1|Outcome|PCI Without IV Opiate|"IV midazolam and Local Anesthetic, with removal of IV fentanyl from peri-procedural analgesia (which is otherwise routinely given)~Removal of Fentanyl from peri-procedural analgesia: Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for PCI)~Lidocaine: Local Anesthetic~Midazolam: IV sedation"
11013|NCT02683707|O2|Outcome|PCI With IV Opiate|"IV midazolam and Local Anesthetic and IV fentanyl for peri-procedural analgesia~Fentanyl: IV peri-procedural analgesia~Lidocaine: Local Anesthetic~Midazolam: IV sedation"
11014|NCT02683707|O1|Outcome|PCI Without IV Opiate|"IV midazolam and Local Anesthetic, with removal of IV fentanyl from peri-procedural analgesia (which is otherwise routinely given)~Removal of Fentanyl from peri-procedural analgesia: Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for PCI)~Lidocaine: Local Anesthetic~Midazolam: IV sedation"
11015|NCT02683707|O2|Outcome|PCI With IV Opiate|"IV midazolam and Local Anesthetic and IV fentanyl for peri-procedural analgesia~Fentanyl: IV peri-procedural analgesia~Lidocaine: Local Anesthetic~Midazolam: IV sedation"
11016|NCT02683707|O1|Outcome|PCI Without IV Opiate|"IV midazolam and Local Anesthetic, with removal of IV fentanyl from peri-procedural analgesia (which is otherwise routinely given)~Removal of Fentanyl from peri-procedural analgesia: Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for PCI)~Lidocaine: Local Anesthetic~Midazolam: IV sedation"
11017|NCT02683707|E2|Reported Event|PCI With IV Opiate|"IV midazolam and Local Anesthetic and IV fentanyl for peri-procedural analgesia~Fentanyl: IV peri-procedural analgesia~Lidocaine: Local Anesthetic~Midazolam: IV sedation"
11018|NCT02683707|E1|Reported Event|PCI Without IV Opiate|"IV midazolam and Local Anesthetic, with removal of IV fentanyl from peri-procedural analgesia (which is otherwise routinely given)~Removal of Fentanyl from peri-procedural analgesia: Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for PCI)~Lidocaine: Local Anesthetic~Midazolam: IV sedation"
11019|NCT02683577|B4|Baseline|Total Title|
11020|NCT02683577|B3|Baseline|Moderate HI|"Subjects in the moderate HI group were assessed as C-P class B (7 to 9 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11021|NCT02683577|B2|Baseline|Mild HI|"Subjects in the mild HI group were assessed as C-P class A (5 to 6 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11022|NCT02683577|B1|Baseline|Healthy Control|"Subjects in the healthy control group were assessed as having normal hepatic function.~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11023|NCT02683577|P3|Participant Flow|Moderate HI|"Subjects in the moderate HI group were assessed as C-P class B (7 to 9 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11024|NCT02683577|P2|Participant Flow|Mild HI|"Subjects in the mild HI group were assessed as C-P class A (5 to 6 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11025|NCT02683577|P1|Participant Flow|Healthy Control|"Subjects in the healthy control group were assessed as having normal hepatic function.~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11026|NCT02683577|O4|Outcome|All HI|The all HI group represented all subjects in either HI group (mild + moderate). All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1.
11027|NCT02683577|O3|Outcome|Moderate HI|"Subjects in the moderate HI group were assessed as C-P class B (7 to 9 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11028|NCT02683577|O2|Outcome|Mild HI|"Subjects in the mild HI group were assessed as C-P class A (5 to 6 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11029|NCT02683577|O1|Outcome|Healthy Control|"Subjects in the healthy control group were assessed as having normal hepatic function.~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11030|NCT02683577|O4|Outcome|All HI|The all HI group represented all subjects in either HI group (mild + moderate). All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1.
11031|NCT02683577|O3|Outcome|Moderate HI|"Subjects in the moderate HI group were assessed as C-P class B (7 to 9 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11032|NCT02683577|O2|Outcome|Mild HI|"Subjects in the mild HI group were assessed as C-P class A (5 to 6 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11033|NCT02683577|O1|Outcome|Healthy Control|"Subjects in the healthy control group were assessed as having normal hepatic function.~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11034|NCT02683577|O4|Outcome|All HI|The all HI group represented all subjects in either HI group (mild + moderate). All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1.
11035|NCT02683577|O3|Outcome|Moderate HI|"Subjects in the moderate HI group were assessed as C-P class B (7 to 9 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11036|NCT02683577|O2|Outcome|Mild HI|"Subjects in the mild HI group were assessed as C-P class A (5 to 6 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11037|NCT02683577|O1|Outcome|Healthy Control|"Subjects in the healthy control group were assessed as having normal hepatic function.~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11038|NCT02683577|O4|Outcome|All HI|The all HI group represented all subjects in either HI group (mild + moderate). All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1.
11039|NCT02683577|O3|Outcome|Moderate HI|"Subjects in the moderate HI group were assessed as C-P class B (7 to 9 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11040|NCT02683577|O2|Outcome|Mild HI|"Subjects in the mild HI group were assessed as C-P class A (5 to 6 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11041|NCT02683577|O1|Outcome|Healthy Control|"Subjects in the healthy control group were assessed as having normal hepatic function.~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11042|NCT02683577|O4|Outcome|All HI|The all HI group represented all subjects in either HI group (mild + moderate). All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1.
11043|NCT02683577|O3|Outcome|Moderate HI|"Subjects in the moderate HI group were assessed as C-P class B (7 to 9 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11044|NCT02683577|O2|Outcome|Mild HI|"Subjects in the mild HI group were assessed as C-P class A (5 to 6 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11045|NCT02683577|O1|Outcome|Healthy Control|"Subjects in the healthy control group were assessed as having normal hepatic function.~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11046|NCT02683577|O4|Outcome|All HI|The all HI group represented all subjects in either HI group (mild + moderate). All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1.
11047|NCT02683577|O3|Outcome|Moderate HI|"Subjects in the moderate HI group were assessed as C-P class B (7 to 9 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11048|NCT02683577|O2|Outcome|Mild HI|"Subjects in the mild HI group were assessed as C-P class A (5 to 6 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11049|NCT02683577|O1|Outcome|Healthy Control|"Subjects in the healthy control group were assessed as having normal hepatic function.~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11050|NCT02683577|O4|Outcome|All HI|The all HI group represented all subjects in either HI group (mild + moderate). All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1.
11051|NCT02683577|O3|Outcome|Moderate HI|"Subjects in the moderate HI group were assessed as C-P class B (7 to 9 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11052|NCT02683577|O2|Outcome|Mild HI|"Subjects in the mild HI group were assessed as C-P class A (5 to 6 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11246|NCT02675907|O2|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11053|NCT02683577|O1|Outcome|Healthy Control|"Subjects in the healthy control group were assessed as having normal hepatic function.~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11054|NCT02683577|O4|Outcome|All HI|The all HI group represented all subjects in either HI group (mild + moderate). All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1.
11055|NCT02683577|O3|Outcome|Moderate HI|"Subjects in the moderate HI group were assessed as C-P class B (7 to 9 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11056|NCT02683577|O2|Outcome|Mild HI|"Subjects in the mild HI group were assessed as C-P class A (5 to 6 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11057|NCT02683577|O1|Outcome|Healthy Control|"Subjects in the healthy control group were assessed as having normal hepatic function.~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11058|NCT02683577|O4|Outcome|All HI|The all HI group represented all subjects in either HI group (mild + moderate). All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1.
11059|NCT02683577|O3|Outcome|Moderate HI|"Subjects in the moderate HI group were assessed as C-P class B (7 to 9 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11060|NCT02683577|O2|Outcome|Mild HI|"Subjects in the mild HI group were assessed as C-P class A (5 to 6 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11061|NCT02683577|O1|Outcome|Healthy Control|"Subjects in the healthy control group were assessed as having normal hepatic function.~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11062|NCT02683577|O4|Outcome|All HI|The all HI group represented all subjects in either HI group (mild + moderate). All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1.
11063|NCT02683577|O3|Outcome|Moderate HI|"Subjects in the moderate HI group were assessed as C-P class B (7 to 9 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11064|NCT02683577|O2|Outcome|Mild HI|"Subjects in the mild HI group were assessed as C-P class A (5 to 6 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11065|NCT02683577|O1|Outcome|Healthy Control|"Subjects in the healthy control group were assessed as having normal hepatic function.~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11066|NCT02683577|E4|Reported Event|All HI|The all HI group represented all subjects in either HI group (mild + moderate). All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1.
11067|NCT02683577|E3|Reported Event|Moderate HI|"Subjects in the moderate HI group were assessed as C-P class B (7 to 9 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11068|NCT02683577|E2|Reported Event|Mild HI|"Subjects in the mild HI group were assessed as C-P class A (5 to 6 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11069|NCT02683577|E1|Reported Event|Healthy Control|"Subjects in the healthy control group were assessed as having normal hepatic function.~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11070|NCT02682498|B3|Baseline|Total|Total of all reporting groups
11071|NCT02682498|B2|Baseline|Standard Periarticular Joint Injection|A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
11072|NCT02682498|B1|Baseline|EXPAREL® Bupivacaine Liposome Suspension|"Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.~(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery."
11073|NCT02682498|P2|Participant Flow|Standard Periarticular Joint Injection|A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
11074|NCT02682498|P1|Participant Flow|EXPAREL® Bupivacaine Liposome Suspension|"Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.~(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery."
11075|NCT02682498|O2|Outcome|Standard Periarticular Joint Injection|A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
11097|NCT02681458|P2|Participant Flow|Non-drug Users|"Control group that consisted of non-drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
11076|NCT02682498|O1|Outcome|EXPAREL® Bupivacaine Liposome Suspension|"Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.~(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery."
11077|NCT02682498|O2|Outcome|Standard Periarticular Joint Injection|A standard joint injection of 100ml (Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml) will be injected into the soft tissues around the joint after surgery.
11078|NCT02682498|O1|Outcome|EXPAREL® Bupivacaine Liposome Suspension|"Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.~(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery."
11079|NCT02682498|O2|Outcome|Standard Periarticular Joint Injection|A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
11080|NCT02682498|O1|Outcome|EXPAREL® Bupivacaine Liposome Suspension|"Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.~(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery."
11081|NCT02682498|O2|Outcome|Standard Periarticular Joint Injection|A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
11082|NCT02682498|O1|Outcome|EXPAREL® Bupivacaine Liposome Suspension|"Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.~(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery."
11083|NCT02682498|O2|Outcome|Standard Periarticular Joint Injection|A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
11084|NCT02682498|O1|Outcome|EXPAREL® Bupivacaine Liposome Suspension|"Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.~(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery."
11085|NCT02682498|E2|Reported Event|Standard Periarticular Joint Injection|A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
11086|NCT02682498|E1|Reported Event|EXPAREL® Bupivacaine Liposome Suspension|"Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.~(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery."
11087|NCT02681510|B1|Baseline|Three Drug Intervention|Varenicline, nicotine patch and nicotine lozenge for 12 weeks
11088|NCT02681510|P1|Participant Flow|Three Drug Intervention|Varenicline, nicotine patch and nicotine lozenge for 12 weeks
11089|NCT02681510|O1|Outcome|Three Drug Intervention|Varenicline, nicotine patch and nicotine lozenge for 12 weeks
11090|NCT02681510|O1|Outcome|Three Drug Intervention|Varenicline, nicotine patch and nicotine lozenge for 12 weeks
11091|NCT02681510|O1|Outcome|Three Drug Intervention|Varenicline, nicotine patch and nicotine lozenge for 12 weeks
11092|NCT02681510|O1|Outcome|Three Drug Intervention|Varenicline, nicotine patch and nicotine lozenge for 12 weeks
11093|NCT02681510|E1|Reported Event|Three Drug Intervention|Varenicline, nicotine patch and nicotine lozenge for 12 weeks
11094|NCT02681458|B3|Baseline|Total|Total of all reporting groups
11095|NCT02681458|B2|Baseline|Non-drug Users|"Control group that consisted of non drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
11096|NCT02681458|B1|Baseline|Drug Users|"Case group that consisted of drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
20056|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
11098|NCT02681458|P1|Participant Flow|Drug Users|"Case group that consisted of drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
11099|NCT02681458|O2|Outcome|Non-drug Users|"Control group that consisted of non-drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
11100|NCT02681458|O1|Outcome|Drug Users|"Case group that consisted of drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
11101|NCT02681458|E2|Reported Event|Non-drug Users|"Control group that consisted of non-drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
11102|NCT02681458|E1|Reported Event|Drug Users|"Case group that consisted of drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
11103|NCT02679976|B1|Baseline|Etafilcon A (Multi-focal)|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
11104|NCT02679976|P1|Participant Flow|Etafilcon A (Multi-focal)|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
11105|NCT02679976|O2|Outcome|Etafilcon A (Multi-focal)- Myopes|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
11106|NCT02679976|O1|Outcome|Etafilcon A (Multi-focal)- Hyperopes|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
11107|NCT02679976|O2|Outcome|Etafilcon A (Multi-focal)- Myopes|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
11108|NCT02679976|O1|Outcome|Etafilcon A (Multi-focal)- Hyperopes|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
11109|NCT02679976|O2|Outcome|Etafilcon A (Multi-focal)- Myopes|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
11110|NCT02679976|O1|Outcome|Etafilcon A (Multi-focal)- Hyperopes|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
11111|NCT02679976|E1|Reported Event|Etafilcon A (Multi-focal)|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
11112|NCT02679469|B1|Baseline|Nalmefene Hydrochloride 10 mg|"nalmefene 10 mg tablet~nalmefene hydrochloride 10 mg"
11113|NCT02679469|P1|Participant Flow|Nalmefene Hydrochloride 10 mg|"nalmefene 10 mg tablet~nalmefene hydrochloride 10 mg"
11114|NCT02679469|O1|Outcome|Nalmefene Hydrochloride 10 mg|"nalmefene 10 mg tablet~nalmefene hydrochloride 10 mg"
11115|NCT02679469|O1|Outcome|Nalmefene Hydrochloride 10 mg|"nalmefene 10 mg tablet~nalmefene hydrochloride 10 mg"
11116|NCT02679469|O1|Outcome|Nalmefene Hydrochloride 10 mg|"nalmefene 10 mg tablet~nalmefene hydrochloride 10 mg"
11117|NCT02679469|E1|Reported Event|Nalmefene Hydrochloride 10 mg|"nalmefene 10 mg tablet~nalmefene hydrochloride 10 mg"
11118|NCT02678923|B3|Baseline|Total|Total of all reporting groups
11119|NCT02678923|B2|Baseline|Placebo|360 mL of placebo (0.9% NaCl solution) infusion, IV, over 2 hours on Days 1, 8, 15, 22, and 29
11120|NCT02678923|B1|Baseline|MDCO-216|20 mg/kg of MDCO-216 administered IV as a 360 mL infusion over 2 hours on Days 1, 8, 15, 22, and 29
11121|NCT02678923|P2|Participant Flow|Placebo|360 mL of placebo (0.9% sodium chloride [NaCl] solution) infusion, IV, over 2 hours on Days 1, 8, 15, 22, and 29
11122|NCT02678923|P1|Participant Flow|MDCO-216|20 milligrams/kilogram (mg/kg) of MDCO-216 administered intravenously (IV) as a 360 milliliter (mL) infusion over 2 hours on Days 1, 8, 15, 22, and 29
11123|NCT02678923|O2|Outcome|Placebo|360 mL of placebo (0.9% NaCl solution) infusion, IV, over 2 hours on Days 1, 8, 15, 22, and 29
11124|NCT02678923|O1|Outcome|MDCO-216|20 mg/kg of MDCO-216 administered IV as a 360 mL infusion over 2 hours on Days 1, 8, 15, 22, and 29
11125|NCT02678923|O2|Outcome|Placebo|360 mL of placebo (0.9% NaCl solution) infusion, IV, over 2 hours on Days 1, 8, 15, 22, and 29
11126|NCT02678923|O1|Outcome|MDCO-216|20 mg/kg of MDCO-216 administered IV as a 360 mL infusion over 2 hours on Days 1, 8, 15, 22, and 29
11127|NCT02678923|O2|Outcome|Placebo|360 mL of placebo (0.9% NaCl solution) infusion, IV, over 2 hours on Days 1, 8, 15, 22, and 29
11128|NCT02678923|O1|Outcome|MDCO-216|20 mg/kg of MDCO-216 administered IV as a 360 mL infusion over 2 hours on Days 1, 8, 15, 22, and 29
11129|NCT02678923|O2|Outcome|Placebo|360 mL of placebo (0.9% NaCl solution) infusion, IV, over 2 hours on Days 1, 8, 15, 22, and 29
11130|NCT02678923|O1|Outcome|MDCO-216|20 mg/kg of MDCO-216 administered IV as a 360 mL infusion over 2 hours on Days 1, 8, 15, 22, and 29
11131|NCT02678923|O2|Outcome|Placebo|360 mL of placebo (0.9% NaCl solution) infusion, IV, over 2 hours on Days 1, 8, 15, 22, and 29
11132|NCT02678923|O1|Outcome|MDCO-216|20 mg/kg of MDCO-216 administered IV as a 360 mL infusion over 2 hours on Days 1, 8, 15, 22, and 29
11133|NCT02678923|E2|Reported Event|Placebo|360 mL of placebo (0.9% NaCl solution) infusion, IV, over 2 hours on Days 1, 8, 15, 22, and 29
11134|NCT02678923|E1|Reported Event|MDCO-216|20 mg/kg of MDCO-216 administered IV as a 360 mL infusion over 2 hours on Days 1, 8, 15, 22, and 29
11135|NCT02678676|B3|Baseline|Total|Total of all reporting groups
11136|NCT02678676|B2|Baseline|Placebo|Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
11137|NCT02678676|B1|Baseline|Pioglitazone|Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
11138|NCT02678676|P2|Participant Flow|Placebo|Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
11247|NCT02675907|O1|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11139|NCT02678676|P1|Participant Flow|Pioglitazone|Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
11140|NCT02678676|O2|Outcome|Placebo|Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
11141|NCT02678676|O1|Outcome|Pioglitazone|Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
11142|NCT02678676|O2|Outcome|Placebo|Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
11143|NCT02678676|O1|Outcome|Pioglitazone|Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
11144|NCT02678676|E2|Reported Event|Placebo|Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
11145|NCT02678676|E1|Reported Event|Pioglitazone|Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
11146|NCT02678286|B3|Baseline|Total|Total of all reporting groups
11147|NCT02678286|B2|Baseline|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11148|NCT02678286|B1|Baseline|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11149|NCT02678286|P2|Participant Flow|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11150|NCT02678286|P1|Participant Flow|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11151|NCT02678286|O2|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11152|NCT02678286|O1|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11153|NCT02678286|O2|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11154|NCT02678286|O1|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11155|NCT02678286|O2|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11156|NCT02678286|O1|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11157|NCT02678286|O2|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11158|NCT02678286|O1|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11159|NCT02678286|O2|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11160|NCT02678286|O1|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11161|NCT02678286|O2|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11162|NCT02678286|O1|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11163|NCT02678286|O2|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11164|NCT02678286|O1|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11165|NCT02678286|O2|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11166|NCT02678286|O1|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11167|NCT02678286|O2|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11168|NCT02678286|O1|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11169|NCT02678286|O2|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11170|NCT02678286|O1|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11171|NCT02678286|O2|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11172|NCT02678286|O1|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11173|NCT02678286|O2|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11174|NCT02678286|O1|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11175|NCT02678286|O2|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11176|NCT02678286|O1|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11177|NCT02678286|E2|Reported Event|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11178|NCT02678286|E1|Reported Event|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11179|NCT02678039|B3|Baseline|Total|Total of all reporting groups
11180|NCT02678039|B2|Baseline|Traditional|"The traditional approach for placement of an epidural catheter is with indirect indicators including palpation of spine and 'loss-of-resistance' to fluid injection.~Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr during and after surgery for pain control.~Traditional: An epidural catheter is placed before surgery with the patient sitting. The catheter is placed using indirect indicators of proper placement: depth of needle insertion and ability to inject solution through the needle ('loss of resistance'). After needle placement, an epidural catheter is threaded through the needle and the needle removed. After catheter is placement, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected to exclude intravascular placement. A continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr up to a maximum of 14ml/hr."
11228|NCT02677493|E1|Reported Event|IL-YANG Quadrivalent Influenza Vaccine|"The QIV is included both B strain (Yamagata, Victoria).~IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
11229|NCT02675907|B3|Baseline|Total|Total of all reporting groups
11230|NCT02675907|B2|Baseline|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11181|NCT02678039|B1|Baseline|Fluoroscopy|"Real-time fluoroscopic X-ray guidance to confirm placement of epidural catheter in the epidural space at the desired location.~Following epidural catheter placement 1/8% bupivacaine is infused at 4ml/hr during and after surgery for pain control.~Fluoroscopy: Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains images of epidural catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr up to a maximum of 14ml/hr"
11182|NCT02678039|P2|Participant Flow|Fluoroscopy|"Real-time fluoroscopic X-ray guidance to confirm placement of an epidural catheter in the epidural space at the desired location.~Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr during and after surgery for pain control.~Fluoroscopy: Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains X-ray images of catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. The bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr up to a maximum of 14ml/hr"
11183|NCT02678039|P1|Participant Flow|Traditional|"The traditional approach for placement of an epidural catheter is indirect indicators of placement including palpation of spine and 'loss-of-resistance' to fluid injection.~Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter for pain control.~Traditional: An epidural catheter is placed before surgery with the patient sitting. The catheter is placed using indirect indicators of placement: depth of needle and ability to inject solution through the needle ('loss of resistance'). After needle placement in the epidural space, an epidural catheter is threaded through the needle and the needle removed. After catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected to exclude intravascular placement. A continuous infusion of 1/8% bupivacaine is started at 4ml/hr. The bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr up to a maximum of 14ml/hr."
11184|NCT02678039|O2|Outcome|Traditional|"The traditional approach for placement of an epidural catheter is used with indirect indicators of placement including palpation of spine and 'loss-of-resistance' to fluid injection.~Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control.~Traditional:An epidural catheter is placed before surgery with the patient sitting at bedside. The catheter is placed with local anesthesia using indirect indicators of proper placement: depth of needle insertion and ability to inject solution through the needle ('loss of resistance'). After needle placement in the epidural space, an epidural catheter is threaded through the needle 3-4 cm and the needle removed. After catheter is placement, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the b"
11185|NCT02678039|O1|Outcome|Fluoroscopy|"Real-time fluoroscopic X-ray guidance to confirm placement of an epidural catheter.~Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control.~Fluoroscopy: Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains X-ray images of epidural catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusi"
11186|NCT02678039|O2|Outcome|Traditional|"The traditional approach for placement of an epidural catheter is used with indirect indicators of placement including palpation of spine and 'loss-of-resistance' to fluid injection.~Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control.~Traditional:An epidural catheter is placed before surgery with the patient sitting at bedside. The catheter is placed with local anesthesia using indirect indicators of proper placement: depth of needle insertion and ability to inject solution through the needle ('loss of resistance'). After needle placement in the epidural space, an epidural catheter is threaded through the needle 3-4 cm and the needle removed. After catheter is placement, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the b"
11187|NCT02678039|O1|Outcome|Fluoroscopy|"Real-time fluoroscopic X-ray guidance to confirm placement of an epidural catheter.~Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control.~Fluoroscopy: Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains X-ray images of epidural catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusi"
11231|NCT02675907|B1|Baseline|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11232|NCT02675907|P2|Participant Flow|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11233|NCT02675907|P1|Participant Flow|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11234|NCT02675907|O2|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11235|NCT02675907|O1|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11188|NCT02678039|O2|Outcome|Traditional|"The traditional approach for placement of an epidural catheter is used with indirect indicators of placement including palpation of spine and 'loss-of-resistance' to fluid injection.~Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control.~Traditional:An epidural catheter is placed before surgery with the patient sitting at bedside. The catheter is placed with local anesthesia using indirect indicators of proper placement: depth of needle insertion and ability to inject solution through the needle ('loss of resistance'). After needle placement in the epidural space, an epidural catheter is threaded through the needle 3-4 cm and the needle removed. After catheter is placement, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the b"
11189|NCT02678039|O1|Outcome|Fluoroscopy|"Real-time fluoroscopic X-ray guidance to confirm placement of an epidural catheter.~Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control.~Fluoroscopy: Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains X-ray images of epidural catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusi"
11190|NCT02678039|O2|Outcome|Traditional|"The traditional approach for placement of an epidural catheter is used with indirect indicators of placement including palpation of spine and 'loss-of-resistance' to fluid injection.~Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control.~Traditional:An epidural catheter is placed before surgery with the patient sitting at bedside. The catheter is placed with local anesthesia using indirect indicators of proper placement: depth of needle insertion and ability to inject solution through the needle ('loss of resistance'). After needle placement in the epidural space, an epidural catheter is threaded through the needle 3-4 cm and the needle removed. After catheter is placement, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the b"
11191|NCT02678039|O1|Outcome|Fluoroscopy|"Real-time fluoroscopic X-ray guidance to confirm placement of an epidural catheter.~Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control.~Fluoroscopy: Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains X-ray images of epidural catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusi"
11192|NCT02678039|O2|Outcome|Traditional|"The traditional approach for placement of an epidural catheter is used with indirect indicators of placement including palpation of spine and 'loss-of-resistance' to fluid injection.~Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control.~Traditional:An epidural catheter is placed before surgery with the patient sitting at bedside. The catheter is placed with local anesthesia using indirect indicators of proper placement: depth of needle insertion and ability to inject solution through the needle ('loss of resistance'). After needle placement in the epidural space, an epidural catheter is threaded through the needle 3-4 cm and the needle removed. After catheter is placement, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the b"
11193|NCT02678039|O1|Outcome|Fluoroscopy|"Real-time fluoroscopic X-ray guidance to confirm placement of an epidural catheter.~Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control.~Fluoroscopy: Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains X-ray images of epidural catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusi"
11194|NCT02678039|E2|Reported Event|Traditional|"The traditional approach for placement of an epidural catheter is used with indirect indicators of placement.~Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr during and after surgery for pain control.~Traditional: An epidural catheter is placed before surgery with the patient sitting at bedside. The catheter is placed with local anesthesia using indirect indicators of proper placement: depth of needle insertion and ability to inject solution through the needle ('loss of resistance'). After needle placement, an epidural catheter is threaded through the needle and the needle removed. After catheter is placement, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr ."
11236|NCT02675907|O2|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11237|NCT02675907|O1|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11238|NCT02675907|O2|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11239|NCT02675907|O1|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11240|NCT02675907|O2|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11241|NCT02675907|O1|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11195|NCT02678039|E1|Reported Event|Fluoroscopy|"Real-time fluoroscopic X-ray guidance to confirm placement of an epidural catheter Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr during and after surgery for pain control.~Fluoroscopy: Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains X-ray images of epidural catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr up to a maximum of 14ml/hr"
11196|NCT02677779|B3|Baseline|Total|Total of all reporting groups
11197|NCT02677779|B2|Baseline|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
11198|NCT02677779|B1|Baseline|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
11199|NCT02677779|P2|Participant Flow|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
11200|NCT02677779|P1|Participant Flow|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
11201|NCT02677779|O2|Outcome|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
11202|NCT02677779|O1|Outcome|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
11203|NCT02677779|O2|Outcome|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
11204|NCT02677779|O1|Outcome|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
11205|NCT02677779|O2|Outcome|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
11206|NCT02677779|O1|Outcome|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
11207|NCT02677779|O2|Outcome|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
11208|NCT02677779|O1|Outcome|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
11209|NCT02677779|O2|Outcome|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
11210|NCT02677779|O1|Outcome|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
11211|NCT02677779|E2|Reported Event|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
11212|NCT02677779|E1|Reported Event|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
11213|NCT02677493|B4|Baseline|Total|Total of all reporting groups
11214|NCT02677493|B3|Baseline|IL-YANG Trivalent Influenza Vaccine|"This TIV is included the B/Victoria strain.~IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
11215|NCT02677493|B2|Baseline|IL-YANG Flu Vaccine Prefilled Syringe|"This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.~IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection."
11216|NCT02677493|B1|Baseline|IL-YANG Quadrivalent Influenza Vaccine|"The QIV is included both B strain (Yamagata, Victoria).~IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
11217|NCT02677493|P3|Participant Flow|IL-YANG Trivalent Influenza Vaccine|"This TIV is included the B/Victoria strain.~IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
11218|NCT02677493|P2|Participant Flow|IL-YANG Flu Vaccine Prefilled Syringe|"This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.~IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection."
11219|NCT02677493|P1|Participant Flow|IL-YANG Quadrivalent Influenza Vaccine|"The QIV is included both B strain (Yamagata, Victoria).~IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
11220|NCT02677493|O3|Outcome|IL-YANG Trivalent Influenza Vaccine|"This TIV is included the B/Victoria strain.~IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
11221|NCT02677493|O2|Outcome|IL-YANG Flu Vaccine Prefilled Syringe|"This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.~IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection."
11222|NCT02677493|O1|Outcome|IL-YANG Quadrivalent Influenza Vaccine|"The QIV is included both B strain (Yamagata, Victoria).~IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
11223|NCT02677493|O3|Outcome|IL-YANG Trivalent Influenza Vaccine|"This TIV is included the B/Victoria strain.~IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
11224|NCT02677493|O2|Outcome|IL-YANG Flu Vaccine Prefilled Syringe|"This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.~IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection."
11225|NCT02677493|O1|Outcome|IL-YANG Quadrivalent Influenza Vaccine|"The QIV is included both B strain (Yamagata, Victoria).~IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
11226|NCT02677493|E3|Reported Event|IL-YANG Trivalent Influenza Vaccine|"This TIV is included the B/Victoria strain.~IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
11227|NCT02677493|E2|Reported Event|IL-YANG Flu Vaccine Prefilled Syringe|"This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.~IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection."
11249|NCT02675907|O1|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11250|NCT02675907|O2|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11251|NCT02675907|O1|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11252|NCT02675907|O2|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11253|NCT02675907|O1|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11254|NCT02675907|O2|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11255|NCT02675907|O1|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11256|NCT02675907|O2|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11257|NCT02675907|O1|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11258|NCT02675907|O2|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11259|NCT02675907|O1|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11260|NCT02675907|E2|Reported Event|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11261|NCT02675907|E1|Reported Event|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11262|NCT02675634|B1|Baseline|The Study Population|This consists of all participants who were enrolled in the study
11263|NCT02675634|P6|Participant Flow|Subjects Own Product, Test B, Test A|"The subjects first test Subjects own product, followed by Test B, and finally Coloplast Test A~Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S~Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S~Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group."
11264|NCT02675634|P5|Participant Flow|Subjects Own Product, Test A, Test B|"The subjects first test Subjects own product, followed by Test A, and finally Coloplast Test B~Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S~Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S~Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group."
11265|NCT02675634|P4|Participant Flow|Test B, Subjects Own Product, Test A|"The subjects first test Coloplast Test B, followed by Subjects own product, and finally Coloplast Test A~Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S~Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S~Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group."
11266|NCT02675634|P3|Participant Flow|Test B, Test A, Subjects Own Product|"The subjects first test Coloplast Test B, followed by Coloplast Test A and finally Subjects own product~Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S~Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S~Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group."
11267|NCT02675634|P2|Participant Flow|Test A, Subjects Own Product, Test B|"The subjects first test Coloplast Test A, followed by Subjects own product, and finally Coloplast Test B~Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S~Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S~Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group."
11268|NCT02675634|P1|Participant Flow|Test A, Test B, Subjects Own Product|"The subjects first test Coloplast Test A, followed by Coloplast Test B and finally Subjects own product~Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S~Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S~Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group."
11269|NCT02675634|O3|Outcome|Own Product|this is the result from all the subjects evaluating Own product.
11270|NCT02675634|O2|Outcome|Test B|This is the results from all the subjects evaluating Test B
11271|NCT02675634|O1|Outcome|Test A|This is the result from all subjects evaluating Test A
11272|NCT02675634|E3|Reported Event|Own Product|this is the result from all the subjects evaluating Own product.
11273|NCT02675634|E2|Reported Event|Test B|This is the results from all the subjects evaluating Test B
11274|NCT02675634|E1|Reported Event|Test A|This is the result from all subjects evaluating Test A
11275|NCT02675543|B3|Baseline|Total|Total of all reporting groups
11276|NCT02675543|B2|Baseline|Heavy Silicone Oil|"after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68)~Vitreous Tamponade with Silicone Oil"
11277|NCT02675543|B1|Baseline|Standard Silicone Oil|"after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS)~Vitreous Tamponade with Silicone Oil"
11278|NCT02675543|P2|Participant Flow|Heavy Silicone Oil|"after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68)~Vitreous Tamponade with Silicone Oil"
11279|NCT02675543|P1|Participant Flow|Standard Silicone Oil|"after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS)~Vitreous Tamponade with Silicone Oil"
11280|NCT02675543|O2|Outcome|Heavy Silicone Oil|"after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68)~Vitreous Tamponade with Silicone Oil"
20057|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
11281|NCT02675543|O1|Outcome|Standard Silicone Oil|"after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS)~Vitreous Tamponade with Silicone Oil"
11282|NCT02675543|E2|Reported Event|Heavy Silicone Oil|"after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68)~Vitreous Tamponade with Silicone Oil"
11283|NCT02675543|E1|Reported Event|Standard Silicone Oil|"after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS)~Vitreous Tamponade with Silicone Oil"
11284|NCT02674334|B3|Baseline|Total|Total of all reporting groups
11285|NCT02674334|B2|Baseline|NIRS Monitored and Treated|Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists treated participants based NIRS monitoring and per standard of care.
11286|NCT02674334|B1|Baseline|NIRS Monitored Not Treated|Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists were blinded to NIRS data and treated participants per standard of care.
11287|NCT02674334|P2|Participant Flow|NIRS Monitored and Treated|Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists treated participants based on the NIRS monitoring in addition to standard of care.
11288|NCT02674334|P1|Participant Flow|NIRS Monitored Not Treated|Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists were blinded to the NIRS data and treated participants based on standard of care treatment.
11289|NCT02674334|O2|Outcome|NIRS Monitored and Treated|Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists treated participants based on NIRS monitoring results in addition to standard of care treatment based on MAP.
11290|NCT02674334|O1|Outcome|NIRS Monitored Not Treated|Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists were blinded to the NIRS monitoring and treated participants per standard of care based on MAP.
11291|NCT02674334|O2|Outcome|NIRS Monitored and Treated|Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists treated participants based on NIRS monitoring results in addition to standard of care treatment based on MAP.
11292|NCT02674334|O1|Outcome|NIRS Monitored Not Treated|Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists were blinded to the NIRS monitoring and treated participants per standard of care based on MAP.
11293|NCT02674334|E2|Reported Event|NIRS Monitored and Treated|Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists treated participants based on the NIRS monitoring in addition to standard of care.
11294|NCT02674334|E1|Reported Event|NIRS Monitored Not Treated|Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists were blinded to the NIRS data and treated participants based on standard of care treatment.
11295|NCT02673944|B1|Baseline|Peritron+|"Patients will undergo a routine urodynamic evaluation, the Peritron+ will be used in conjunction with a water-based urodynamic catheter~Peritron+: Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure"
11296|NCT02673944|P1|Participant Flow|Peritron+|"Patients will undergo a routine urodynamic evaluation, the Peritron+ will be used in conjunction with a water-based urodynamic catheter~Peritron+: Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure"
11297|NCT02673944|O2|Outcome|Standard Urodynamic Analyzer|Patients will undergo a routine urodynamic evaluation, which will collect both Peritorn+ and UDS data.
11298|NCT02673944|O1|Outcome|Peritron+|"Patients will undergo a routine urodynamic evaluation, the Peritron+ will be used in conjunction with a water-based urodynamic catheter~Peritron+: Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure"
11299|NCT02673944|E1|Reported Event|Peritron+|"Patients will undergo a routine urodynamic evaluation, the Peritron+ will be used in conjunction with a water-based urodynamic catheter~Peritron+: Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure"
11300|NCT02673619|B5|Baseline|Total|Total of all reporting groups
11301|NCT02673619|B4|Baseline|Lower Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11302|NCT02673619|B3|Baseline|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11303|NCT02673619|B2|Baseline|Higher Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11304|NCT02673619|B1|Baseline|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11305|NCT02673619|P4|Participant Flow|Lower Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11306|NCT02673619|P3|Participant Flow|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11307|NCT02673619|P2|Participant Flow|Higher Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11308|NCT02673619|P1|Participant Flow|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11309|NCT02673619|O4|Outcome|Lower Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11310|NCT02673619|O3|Outcome|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11311|NCT02673619|O2|Outcome|Higher Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11312|NCT02673619|O1|Outcome|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11313|NCT02673619|O4|Outcome|Lower Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11314|NCT02673619|O3|Outcome|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11315|NCT02673619|O2|Outcome|Higher Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11316|NCT02673619|O1|Outcome|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11317|NCT02673619|O4|Outcome|Lower Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11318|NCT02673619|O3|Outcome|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11319|NCT02673619|O2|Outcome|Higher Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11320|NCT02673619|O1|Outcome|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11321|NCT02673619|O4|Outcome|Lower Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11322|NCT02673619|O3|Outcome|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11323|NCT02673619|O2|Outcome|Higher Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11324|NCT02673619|O1|Outcome|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11325|NCT02673619|O4|Outcome|Lower Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11326|NCT02673619|O3|Outcome|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11327|NCT02673619|O2|Outcome|Higher Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11328|NCT02673619|O1|Outcome|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11329|NCT02673619|O4|Outcome|Lower Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11330|NCT02673619|O3|Outcome|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11331|NCT02673619|O2|Outcome|Higher Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11332|NCT02673619|O1|Outcome|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11333|NCT02673619|O4|Outcome|Lower Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11334|NCT02673619|O3|Outcome|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11335|NCT02673619|O2|Outcome|Higher Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11336|NCT02673619|O1|Outcome|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11449|NCT02671760|E1|Reported Event|Treatment|"SM-1~SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam"
11337|NCT02673619|O2|Outcome|Higher Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11338|NCT02673619|O1|Outcome|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11339|NCT02673619|O4|Outcome|Lower Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11340|NCT02673619|O3|Outcome|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11341|NCT02673619|O2|Outcome|Higher Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11342|NCT02673619|O1|Outcome|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11343|NCT02673619|O4|Outcome|Lower Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11344|NCT02673619|O3|Outcome|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11345|NCT02673619|O2|Outcome|Higher Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11346|NCT02673619|O1|Outcome|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11347|NCT02673619|O2|Outcome|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11348|NCT02673619|O1|Outcome|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11349|NCT02673619|O2|Outcome|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11350|NCT02673619|O1|Outcome|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11351|NCT02673619|O2|Outcome|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11352|NCT02673619|O1|Outcome|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11353|NCT02673619|O4|Outcome|Lower Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11354|NCT02673619|O3|Outcome|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11355|NCT02673619|O2|Outcome|Higher Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11356|NCT02673619|O1|Outcome|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11357|NCT02673619|O4|Outcome|Lower Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11358|NCT02673619|O3|Outcome|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11359|NCT02673619|O2|Outcome|Higher Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11360|NCT02673619|O1|Outcome|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11361|NCT02673619|O2|Outcome|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11362|NCT02673619|O1|Outcome|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11363|NCT02673619|O2|Outcome|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11364|NCT02673619|O1|Outcome|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11365|NCT02673619|O2|Outcome|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11366|NCT02673619|O1|Outcome|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11367|NCT02673619|O4|Outcome|Lower Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11368|NCT02673619|O3|Outcome|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11369|NCT02673619|O2|Outcome|Higher Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11370|NCT02673619|O1|Outcome|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11371|NCT02673619|O4|Outcome|Lower Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11372|NCT02673619|O3|Outcome|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11373|NCT02673619|O2|Outcome|Higher Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11374|NCT02673619|O1|Outcome|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11375|NCT02673619|O4|Outcome|Lower Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11376|NCT02673619|O3|Outcome|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11377|NCT02673619|O2|Outcome|Higher Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11378|NCT02673619|O1|Outcome|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11379|NCT02673619|O4|Outcome|Lower Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11380|NCT02673619|O3|Outcome|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11381|NCT02673619|O2|Outcome|Higher Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11382|NCT02673619|O1|Outcome|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11383|NCT02673619|O4|Outcome|Lower Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11384|NCT02673619|O3|Outcome|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11385|NCT02673619|O2|Outcome|Higher Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11386|NCT02673619|O1|Outcome|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11387|NCT02673619|O4|Outcome|Lower Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11388|NCT02673619|O3|Outcome|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11389|NCT02673619|O2|Outcome|Higher Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11390|NCT02673619|O1|Outcome|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11391|NCT02673619|O2|Outcome|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11392|NCT02673619|O1|Outcome|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11450|NCT02670811|B3|Baseline|Total|Total of all reporting groups
11393|NCT02673619|E4|Reported Event|Lower Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11394|NCT02673619|E3|Reported Event|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11395|NCT02673619|E2|Reported Event|Higher Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11396|NCT02673619|E1|Reported Event|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11397|NCT02673489|B3|Baseline|Total|Total of all reporting groups
11398|NCT02673489|B2|Baseline|Treatment Experienced|HCV treatment-experienced: Previous treatment with IFN/RBV, SOF + RBV, and other anti-HCV agents
11399|NCT02673489|B1|Baseline|Treatment Naive|HCV treatment-naive: No previous exposure to any interferon (IFN) formulation (ie, IFN or peg-IFN), RBV, or any HCV DAAs
11400|NCT02673489|P2|Participant Flow|Treatment Experienced|HCV treatment-experienced: Previous treatment with IFN/RBV, SOF + RBV, and other anti-HCV agents
11401|NCT02673489|P1|Participant Flow|Treatment Naive|HCV treatment-naive: No previous exposure to any interferon (IFN) formulation (ie, IFN or peg-IFN), RBV, or any HCV DAAs
11402|NCT02673489|O2|Outcome|HCV Treatment Experienced|HCV treatment-experienced: Previous treatment with IFN/RBV, SOF + RBV, and other anti-HCV agents
11403|NCT02673489|O1|Outcome|HCV Treatment Naive|HCV treatment-naive: No previous exposure to any interferon (IFN) formulation (ie, IFN or peg-IFN), RBV, or any HCV DAAs
11404|NCT02673489|O2|Outcome|HCV Treatment Experienced|HCV treatment-experienced: Previous treatment with IFN/RBV, SOF + RBV, and other anti-HCV agents
11405|NCT02673489|O1|Outcome|HCV Treatment Naive|HCV treatment-naive: No previous exposure to any interferon (IFN) formulation (ie, IFN or peg-IFN), RBV, or any HCV DAAs
11406|NCT02673489|O2|Outcome|HCV Treatment Experienced|HCV treatment-experienced: Previous treatment with IFN/RBV, SOF + RBV, and other anti-HCV agents
11407|NCT02673489|O1|Outcome|HCV Treatment Naive|HCV treatment-naive: No previous exposure to any interferon (IFN) formulation (ie, IFN or peg-IFN), RBV, or any HCV DAAs
11408|NCT02673489|O2|Outcome|HCV Treatment Experienced|HCV treatment-experienced: Previous treatment with IFN/RBV, SOF + RBV, and other anti-HCV agents
11409|NCT02673489|O1|Outcome|HCV Treatment Naive|HCV treatment-naive: No previous exposure to any interferon (IFN) formulation (ie, IFN or peg-IFN), RBV, or any HCV DAAs
11410|NCT02673489|E3|Reported Event|HCV Treatment Experienced|HCV treatment-experienced: Previous treatment with IFN/RBV, SOF + RBV, and other anti-HCV agents
11411|NCT02673489|E2|Reported Event|HCV Treatment Naive|HCV treatment-naive: No previous exposure to any interferon (IFN) formulation (ie, IFN or peg-IFN), RBV, or any HCV DAAs
11412|NCT02673489|E1|Reported Event|Overall: Daclatasvir(DCV) + Sofosbuvir(SOF) + Ribavirin(RBV)|Oral dosing of DCV 60 mg tablet once daily + SOF 400 mg tablet once daily + RBV 1000-1200 mg tablet per day (weight based) for 24 weeks.
11413|NCT02672514|B3|Baseline|Total|Total of all reporting groups
11414|NCT02672514|B2|Baseline|Group A|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the conventional extracorporeal circulation system (CECC). The CECC is an opened circulation system. The basic elements are a membrane oxygenator, a centrifugal pump, an open perfusion system containing the venous hard shell cardiotomy reservoir and the arterial line filter.~CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation, leading to a reduction of the priming volume. The CECC flow was set as required in order to maintain a mean arterial pressure (MAP) between 50 and 75 mmHg.~Conventional extracorporeal circulation (CECC): Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass."
11415|NCT02672514|B1|Baseline|Group B|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the minimally invasive extracorporeal circulation system (MiECC). MiECC has been developed based on the concept of a closed total CPB circuit. The basic elements are a centrifugal pump, a membrane oxygenator and an arterial filter. The priming volume compared to CECC could be reduced. The complete circuit is heparin-coated for maximizing the biocompatibility.~CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation.~Minimally invasive extracorporeal circulation (MiECC): Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass."
11416|NCT02672514|P2|Participant Flow|CECC|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the conventional extracorporeal circulation system (CECC). The CECC is an opened circulation system. The basic elements are a membrane oxygenator, a centrifugal pump, an open perfusion system containing the venous hard shell cardiotomy reservoir and the arterial line filter.~CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation, leading to a reduction of the priming volume. The CECC flow was set as required in order to maintain a mean arterial pressure (MAP) between 50 and 75 mmHg.~Conventional extracorporeal circulation (CECC): Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass."
11417|NCT02672514|P1|Participant Flow|MiECC|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the minimally invasive extracorporeal circulation system (MiECC). MiECC has been developed based on the concept of a closed total CPB circuit. The basic elements are a centrifugal pump, a membrane oxygenator and an arterial filter. The priming volume compared to CECC could be reduced. The complete circuit is heparin-coated for maximizing the biocompatibility.~CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation.~Minimally invasive extracorporeal circulation (MiECC): Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass."
11509|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
11418|NCT02672514|O2|Outcome|Group A|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the conventional extracorporeal circulation system (CECC). The CECC is an opened circulation system. The basic elements are a membrane oxygenator, a centrifugal pump, an open perfusion system containing the venous hard shell cardiotomy reservoir and the arterial line filter.~CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation, leading to a reduction of the priming volume. The CECC flow was set as required in order to maintain a mean arterial pressure (MAP) between 50 and 75 mmHg.~Conventional extracorporeal circulation (CECC): Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass."
11419|NCT02672514|O1|Outcome|Group B|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the minimally invasive extracorporeal circulation system (MiECC). MiECC has been developed based on the concept of a closed total CPB circuit. The basic elements are a centrifugal pump, a membrane oxygenator and an arterial filter. The priming volume compared to CECC could be reduced. The complete circuit is heparin-coated for maximizing the biocompatibility.~CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation.~Minimally invasive extracorporeal circulation (MiECC): Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass."
11420|NCT02672514|E2|Reported Event|CECC|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the conventional extracorporeal circulation system (CECC). The CECC is an opened circulation system. The basic elements are a membrane oxygenator, a centrifugal pump, an open perfusion system containing the venous hard shell cardiotomy reservoir and the arterial line filter.~CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation, leading to a reduction of the priming volume. The CECC flow was set as required in order to maintain a mean arterial pressure (MAP) between 50 and 75 mmHg.~Conventional extracorporeal circulation (CECC): Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass."
11421|NCT02672514|E1|Reported Event|MiECC|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the minimally invasive extracorporeal circulation system (MiECC). MiECC has been developed based on the concept of a closed total CPB circuit. The basic elements are a centrifugal pump, a membrane oxygenator and an arterial filter. The priming volume compared to CECC could be reduced. The complete circuit is heparin-coated for maximizing the biocompatibility.~CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation.~Minimally invasive extracorporeal circulation (MiECC): Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass."
11422|NCT02671760|B1|Baseline|All Study Participants|All study participants regardless of randomization sequence.
11423|NCT02671760|P3|Participant Flow|Experimental: Placebo Then SM-1 Then Comparator|Subjects received a single dose of Placebo followed by a 5-16 day washout. They the received a single dose of SM-1 followed by a 5-16 day washout. They then received a single dose of Comparator.
11424|NCT02671760|P2|Participant Flow|Experimental: Comparator Then Placebo Then SM-1|Subjects received a single dose of Comparator followed by a 5-16 day washout. They the received a single dose of Placebo followed by a 5-16 day washout. They then received a single dose of SM-1.
11425|NCT02671760|P1|Participant Flow|Experimental: SM-1 Then Comparator Then Placebo|Subjects received a single dose of SM-1 followed by a 5-16 day washout. They the received a single dose of Comparator followed by a 5-16 day washout. They then received a single dose of Placebo.
11426|NCT02671760|O3|Outcome|Placebo|"Placebo~Placebo: Placebo"
11427|NCT02671760|O2|Outcome|Comparator|"2-drug combination~Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam"
11428|NCT02671760|O1|Outcome|Treatment|"SM-1~SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam"
11429|NCT02671760|O3|Outcome|Placebo|"Placebo~Placebo: Placebo"
11430|NCT02671760|O2|Outcome|Comparator|"2-drug combination~Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam"
11431|NCT02671760|O1|Outcome|Treatment|"SM-1~SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam"
11432|NCT02671760|O3|Outcome|Placebo|"Placebo~Placebo: Placebo"
11433|NCT02671760|O2|Outcome|Comparator|"2-drug combination~Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam"
11434|NCT02671760|O1|Outcome|Treatment|"SM-1~SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam"
11435|NCT02671760|O3|Outcome|Placebo|"Placebo~Placebo: Placebo"
11436|NCT02671760|O2|Outcome|Comparator|"2-drug combination~Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam"
11437|NCT02671760|O1|Outcome|Treatment|"SM-1~SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam"
11438|NCT02671760|O3|Outcome|Placebo|"Placebo~Placebo: Placebo"
11439|NCT02671760|O2|Outcome|Comparator|"2-drug combination~Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam"
11440|NCT02671760|O1|Outcome|Treatment|"SM-1~SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam"
11441|NCT02671760|O3|Outcome|Placebo|"Placebo~Placebo: Placebo"
11442|NCT02671760|O2|Outcome|Comparator|"2-drug combination~Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam"
11443|NCT02671760|O1|Outcome|Treatment|"SM-1~SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam"
11444|NCT02671760|O3|Outcome|Placebo|"Placebo~Placebo: Placebo"
11445|NCT02671760|O2|Outcome|Comparator|"2-drug combination~Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam"
11446|NCT02671760|O1|Outcome|Treatment|"SM-1~SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam"
11447|NCT02671760|E3|Reported Event|Placebo|"Placebo~Placebo: Placebo"
11448|NCT02671760|E2|Reported Event|Comparator|"2-drug combination~Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam"
11510|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
11451|NCT02670811|B2|Baseline|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
11452|NCT02670811|B1|Baseline|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
11453|NCT02670811|P2|Participant Flow|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
11454|NCT02670811|P1|Participant Flow|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
11455|NCT02670811|O2|Outcome|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
11456|NCT02670811|O1|Outcome|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
11457|NCT02670811|O2|Outcome|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
11458|NCT02670811|O1|Outcome|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
11459|NCT02670811|O2|Outcome|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
11460|NCT02670811|O1|Outcome|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
11461|NCT02670811|O2|Outcome|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
11462|NCT02670811|O1|Outcome|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
11463|NCT02670811|O2|Outcome|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
11464|NCT02670811|O1|Outcome|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
11465|NCT02670811|O2|Outcome|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
11466|NCT02670811|O1|Outcome|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
11467|NCT02670811|E2|Reported Event|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
11468|NCT02670811|E1|Reported Event|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
11469|NCT02670473|B1|Baseline|Overall Participants|"Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.~fanfilcon A (test): contact lens"
11470|NCT02670473|P1|Participant Flow|Overall Participants|"Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.~fanfilcon A (test): contact lens"
11471|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
11472|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
11473|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
11474|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
11475|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
11476|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
11477|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
11478|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
11479|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
11480|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
11481|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
11482|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
11483|NCT02670473|O2|Outcome|Fanfilcon A Lens (Test)|fanfilcon A lens (test)
11484|NCT02670473|O1|Outcome|Habitual Lenses|enfilcon A habitual lens (control)
11485|NCT02670473|O4|Outcome|Completely Dissatisfied|
11486|NCT02670473|O3|Outcome|Somewhat Dissatisfied|
11487|NCT02670473|O2|Outcome|Somewhat Satisfied|
11488|NCT02670473|O1|Outcome|Completely Satisfied|
11489|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
11490|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
11491|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
11492|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
11493|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
11494|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
11495|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
11496|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
11497|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
11498|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
11499|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
11500|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
11501|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
11502|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
11503|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
11504|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
11505|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
11506|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
11507|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
11508|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
11521|NCT02670473|E1|Reported Event|Overall Participants|"Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.~fanfilcon A (test): contact lens"
11522|NCT02670343|B1|Baseline|Oral Testosterone Undecanoate|"A single dose of oral testosterone undecanoate equivalent to 200 mg of testosterone in the form of two soft gelatin capsules containing 158 mg of testosterone undecanoate will be administered to each subject.~Oral Testosterone Undecanoate: Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone."
11523|NCT02670343|P1|Participant Flow|Oral Testosterone Undecanoate|"A single dose of oral testosterone undecanoate equivalent to 200 mg of testosterone in the form of two soft gelatin capsules containing 158 mg of testosterone undecanoate will be administered to each subject.~Oral Testosterone Undecanoate: Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone."
11524|NCT02670343|O1|Outcome|Oral Testosterone Undecanoate|"A single dose of oral testosterone undecanoate equivalent to 200 mg of testosterone in the form of two soft gelatin capsules containing 158 mg of testosterone undecanoate will be administered to each subject.~Oral Testosterone Undecanoate: Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone."
11525|NCT02670343|E1|Reported Event|Oral Testosterone Undecanoate|"A single dose of oral testosterone undecanoate equivalent to 200 mg of testosterone in the form of two soft gelatin capsules containing 158 mg of testosterone undecanoate will be administered to each subject.~Oral Testosterone Undecanoate: Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone."
11526|NCT02669095|B3|Baseline|Total|Total of all reporting groups
11527|NCT02669095|B2|Baseline|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.
11528|NCT02669095|B1|Baseline|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.
11529|NCT02669095|P2|Participant Flow|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.
11530|NCT02669095|P1|Participant Flow|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.
11531|NCT02669095|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.
11532|NCT02669095|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.
11533|NCT02669095|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.
11534|NCT02669095|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.
11535|NCT02669095|E2|Reported Event|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.
11536|NCT02669095|E1|Reported Event|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.
11537|NCT02669043|B1|Baseline|Ketamine|"All participants receive open-label ketamine~Ketamine: Intravenous ketamine 0.5mg/kg over 40 minutes"
11538|NCT02669043|P1|Participant Flow|Ketamine|"All participants receive open-label ketamine~Ketamine: Intravenous ketamine 0.5mg/kg over 40 minutes"
11539|NCT02669043|O1|Outcome|Ketamine|"All participants receive open-label ketamine~Ketamine: Intravenous ketamine 0.5mg/kg over 40 minutes"
11540|NCT02669043|E1|Reported Event|Ketamine|"All participants receive open-label ketamine~Ketamine: Intravenous ketamine 0.5mg/kg over 40 minutes"
11541|NCT02668952|B3|Baseline|Total|Total of all reporting groups
11542|NCT02668952|B2|Baseline|Isolyte Group|"Isolyte S (B Braun, Irvine CA) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients. Isolyte S is a prepackaged solution containing sodium chloride 0.53%, sodium gluconate 0.5%, sodium acetate trihydrate 0.37%, potassium chloride 0.037%, and magnesium chloride hexahydrate 0.03% w/v.~Isolyte S injection"
11543|NCT02668952|B1|Baseline|Normal Saline Group|"0.9% Normal Saline (0.9% Sodium Chloride) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients.~0.9% Normal Saline (0.9% Sodium Chloride) injection"
11544|NCT02668952|P2|Participant Flow|Isolyte Group|"Isolyte S (B Braun, Irvine CA) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients. Isolyte S is a prepackaged solution containing sodium chloride 0.53%, sodium gluconate 0.5%, sodium acetate trihydrate 0.37%, potassium chloride 0.037%, and magnesium chloride hexahydrate 0.03% w/v.~Isolyte S injection"
11545|NCT02668952|P1|Participant Flow|Normal Saline Group|"0.9% Normal Saline (0.9% Sodium Chloride) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients.~0.9% Normal Saline (0.9% Sodium Chloride) injection"
11546|NCT02668952|O2|Outcome|Isolyte Group|"Isolyte S (B Braun, Irvine CA) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients. Isolyte S is a prepackaged solution containing sodium chloride 0.53%, sodium gluconate 0.5%, sodium acetate trihydrate 0.37%, potassium chloride 0.037%, and magnesium chloride hexahydrate 0.03% w/v.~Isolyte S injection"
11547|NCT02668952|O1|Outcome|Normal Saline Group|"0.9% Normal Saline (0.9% Sodium Chloride) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients.~0.9% Normal Saline (0.9% Sodium Chloride) injection"
11568|NCT02668822|O1|Outcome|ENG 125 μg + E2 300 μg (MK-8342B)|Participants received up to 4 cycles of ENG-E2 at a daily dose of 125 μg/300 μg via vaginal ring. Each cycle consisted of 21 days of MK-8342B vaginal ring use followed by 7 ring-free days.
11569|NCT02668822|O2|Outcome|Placebo|Participants received up to 4 cycles of placebo via vaginal ring. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
11548|NCT02668952|O2|Outcome|Isolyte Group|"Isolyte S (B Braun, Irvine CA) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients. Isolyte S is a prepackaged solution containing sodium chloride 0.53%, sodium gluconate 0.5%, sodium acetate trihydrate 0.37%, potassium chloride 0.037%, and magnesium chloride hexahydrate 0.03% w/v.~Isolyte S injection"
11549|NCT02668952|O1|Outcome|Normal Saline Group|"0.9% Normal Saline (0.9% Sodium Chloride) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients.~0.9% Normal Saline (0.9% Sodium Chloride) injection"
11550|NCT02668952|O2|Outcome|Isolyte Group|"Isolyte S (B Braun, Irvine CA) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients. Isolyte S is a prepackaged solution containing sodium chloride 0.53%, sodium gluconate 0.5%, sodium acetate trihydrate 0.37%, potassium chloride 0.037%, and magnesium chloride hexahydrate 0.03% w/v.~Isolyte S injection"
11551|NCT02668952|O1|Outcome|Normal Saline Group|"0.9% Normal Saline (0.9% Sodium Chloride) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients.~0.9% Normal Saline (0.9% Sodium Chloride) injection"
11552|NCT02668952|O2|Outcome|Isolyte Group|"Isolyte S (B Braun, Irvine CA) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients. Isolyte S is a prepackaged solution containing sodium chloride 0.53%, sodium gluconate 0.5%, sodium acetate trihydrate 0.37%, potassium chloride 0.037%, and magnesium chloride hexahydrate 0.03% w/v.~Isolyte S injection"
11553|NCT02668952|O1|Outcome|Normal Saline Group|"0.9% Normal Saline (0.9% Sodium Chloride) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients.~0.9% Normal Saline (0.9% Sodium Chloride) injection"
11554|NCT02668952|O2|Outcome|Isolyte Group|"Isolyte S (B Braun, Irvine CA) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients. Isolyte S is a prepackaged solution containing sodium chloride 0.53%, sodium gluconate 0.5%, sodium acetate trihydrate 0.37%, potassium chloride 0.037%, and magnesium chloride hexahydrate 0.03% w/v.~Isolyte S injection"
11555|NCT02668952|O1|Outcome|Normal Saline Group|"0.9% Normal Saline (0.9% Sodium Chloride) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients.~0.9% Normal Saline (0.9% Sodium Chloride) injection"
11556|NCT02668952|O2|Outcome|Isolyte Group|"Isolyte S (B Braun, Irvine CA) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients. Isolyte S is a prepackaged solution containing sodium chloride 0.53%, sodium gluconate 0.5%, sodium acetate trihydrate 0.37%, potassium chloride 0.037%, and magnesium chloride hexahydrate 0.03% w/v.~Isolyte S injection"
11557|NCT02668952|O1|Outcome|Normal Saline Group|"0.9% Normal Saline (0.9% Sodium Chloride) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients.~0.9% Normal Saline (0.9% Sodium Chloride) injection"
11558|NCT02668952|O2|Outcome|Isolyte Group|"Isolyte S (B Braun, Irvine CA) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients. Isolyte S is a prepackaged solution containing sodium chloride 0.53%, sodium gluconate 0.5%, sodium acetate trihydrate 0.37%, potassium chloride 0.037%, and magnesium chloride hexahydrate 0.03% w/v.~Isolyte S injection"
11559|NCT02668952|O1|Outcome|Normal Saline Group|"0.9% Normal Saline (0.9% Sodium Chloride) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients.~0.9% Normal Saline (0.9% Sodium Chloride) injection"
11560|NCT02668952|E2|Reported Event|Isolyte Group|"Isolyte S (B Braun, Irvine CA) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients. Isolyte S is a prepackaged solution containing sodium chloride 0.53%, sodium gluconate 0.5%, sodium acetate trihydrate 0.37%, potassium chloride 0.037%, and magnesium chloride hexahydrate 0.03% w/v.~Isolyte S injection"
11561|NCT02668952|E1|Reported Event|Normal Saline Group|"0.9% Normal Saline (0.9% Sodium Chloride) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients.~0.9% Normal Saline (0.9% Sodium Chloride) injection"
11562|NCT02668822|B3|Baseline|Total|Total of all reporting groups
11563|NCT02668822|B2|Baseline|Placebo|Participants received up to 4 cycles of placebo via vaginal ring. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
11564|NCT02668822|B1|Baseline|ENG 125 μg + E2 300 μg (MK-8342B)|Participants received up to 4 cycles of ENG-E2 at a daily dose of 125 μg/300 μg via vaginal ring. Each cycle consisted of 21 days of MK-8342B vaginal ring use followed by 7 ring-free days.
11565|NCT02668822|P2|Participant Flow|Placebo|Participants received up to 4 cycles of placebo via vaginal ring. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
11566|NCT02668822|P1|Participant Flow|ENG 125 μg + E2 300 μg (MK-8342B)|Participants received up to 4 cycles of etonogestrel-17β-estradiol (ENG-E2) at a daily dose of 125 μg/300 μg via vaginal ring. Each cycle consisted of 21 days of MK-8342B vaginal ring use followed by 7 ring-free days.
11567|NCT02668822|O2|Outcome|Placebo|Participants received up to 4 cycles of placebo via vaginal ring. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
11570|NCT02668822|O1|Outcome|ENG 125 μg + E2 300 μg (MK-8342B)|Participants received up to 4 cycles of ENG-E2 at a daily dose of 125 μg/300 μg via vaginal ring. Each cycle consisted of 21 days of MK-8342B vaginal ring use followed by 7 ring-free days.
11571|NCT02668822|O2|Outcome|Placebo|Participants received up to 4 cycles of placebo via vaginal ring. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
11572|NCT02668822|O1|Outcome|ENG 125 μg + E2 300 μg (MK-8342B)|Participants received up to 4 cycles of ENG-E2 at a daily dose of 125 μg/300 μg via vaginal ring. Each cycle consisted of 21 days of MK-8342B vaginal ring use followed by 7 ring-free days.
11573|NCT02668822|O2|Outcome|Placebo|Participants received up to 4 cycles of placebo via vaginal ring. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
11574|NCT02668822|O1|Outcome|ENG 125 μg + E2 300 μg (MK-8342B)|Participants received up to 4 cycles of ENG-E2 at a daily dose of 125 μg/300 μg via vaginal ring. Each cycle consisted of 21 days of MK-8342B vaginal ring use followed by 7 ring-free days.
11575|NCT02668822|O2|Outcome|Placebo|Participants received up to 4 cycles of placebo via vaginal ring. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
11576|NCT02668822|O1|Outcome|ENG 125 μg + E2 300 μg (MK-8342B)|Participants received up to 4 cycles of ENG-E2 at a daily dose of 125 μg/300 μg via vaginal ring. Each cycle consisted of 21 days of MK-8342B vaginal ring use followed by 7 ring-free days.
11577|NCT02668822|O2|Outcome|Placebo|Participants received up to 4 cycles of placebo via vaginal ring. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
11578|NCT02668822|O1|Outcome|ENG 125 μg + E2 300 μg (MK-8342B)|Participants received up to 4 cycles of ENG-E2 at a daily dose of 125 μg/300 μg via vaginal ring. Each cycle consisted of 21 days of MK-8342B vaginal ring use followed by 7 ring-free days.
11579|NCT02668822|O2|Outcome|Placebo|Participants received up to 4 cycles of placebo via vaginal ring. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
11580|NCT02668822|O1|Outcome|ENG 125 μg + E2 300 μg (MK-8342B)|Participants received up to 4 cycles of ENG-E2 at a daily dose of 125 μg/300 μg via vaginal ring. Each cycle consisted of 21 days of MK-8342B vaginal ring use followed by 7 ring-free days.
11581|NCT02668822|O2|Outcome|Placebo|Participants received up to 4 cycles of placebo via vaginal ring. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
11582|NCT02668822|O1|Outcome|ENG 125 μg + E2 300 μg (MK-8342B)|Participants received up to 4 cycles of ENG-E2 at a daily dose of 125 μg/300 μg via vaginal ring. Each cycle consisted of 21 days of MK-8342B vaginal ring use followed by 7 ring-free days.
11583|NCT02668822|E2|Reported Event|Placebo|Participants received up to 4 cycles of placebo via vaginal ring. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
11584|NCT02668822|E1|Reported Event|ENG 125 μg + E2 300 μg (MK-8342B)|Participants received up to 4 cycles of ENG-E2 at a daily dose of 125 μg/300 μg via vaginal ring. Each cycle consisted of 21 days of MK-8342B vaginal ring use followed by 7 ring-free days.
11585|NCT02668783|B3|Baseline|Total|Total of all reporting groups
11586|NCT02668783|B2|Baseline|Placebo|Participants received 4 (or 6 cycles if also participating in the extension) of placebo. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
11587|NCT02668783|B1|Baseline|ENG-E2 125 μg/300 μg|Participants received 4 (or 6 cycles if also participating in the extension) of ENG-E2 125 μg/300 μg. Each cycle consisted of 21 days of vaginal ring use followed by 7 ring-free days.
11588|NCT02668783|P2|Participant Flow|Placebo|Participants received 4 (or 6 cycles if also participating in the extension) of placebo. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
11589|NCT02668783|P1|Participant Flow|ENG-E2 125 μg/300 μg|Participants received 4 (or 6 cycles if also participating in the extension) of ENG-E2 125 μg/300 μg. Each cycle consisted of 21 days of vaginal ring use followed by 7 ring-free days.
11590|NCT02668783|O2|Outcome|Placebo|Participants received 4 (or 6 cycles if also participating in the extension) of placebo. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
11591|NCT02668783|O1|Outcome|ENG-E2 125 μg/300 μg|Participants received 4 (or 6 cycles if also participating in the extension) of ENG-E2 125 μg/300 μg. Each cycle consisted of 21 days of vaginal ring use followed by 7 ring-free days.
11592|NCT02668783|O2|Outcome|Placebo|Participants received 4 (or 6 cycles if also participating in the extension) of placebo. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
11593|NCT02668783|O1|Outcome|ENG-E2 125 μg/300 μg|Participants received 4 (or 6 cycles if also participating in the extension) of ENG-E2 125 μg/300 μg. Each cycle consisted of 21 days of vaginal ring use followed by 7 ring-free days.
11594|NCT02668783|O2|Outcome|Placebo|Participants received 4 (or 6 cycles if also participating in the extension) of placebo. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
11595|NCT02668783|O1|Outcome|ENG-E2 125 μg/300 μg|Participants received 4 (or 6 cycles if also participating in the extension) of ENG-E2 125 μg/300 μg. Each cycle consisted of 21 days of vaginal ring use followed by 7 ring-free days.
11596|NCT02668783|O2|Outcome|Placebo|Participants received 4 (or 6 cycles if also participating in the extension) of placebo. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
11597|NCT02668783|O1|Outcome|ENG-E2 125 μg/300 μg|Participants received 4 (or 6 cycles if also participating in the extension) of ENG-E2 125 μg/300 μg. Each cycle consisted of 21 days of vaginal ring use followed by 7 ring-free days.
11598|NCT02668783|O2|Outcome|Placebo|Participants received 4 (or 6 cycles if also participating in the extension) of placebo. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
11599|NCT02668783|O1|Outcome|ENG-E2 125 μg/300 μg|Participants received 4 (or 6 cycles if also participating in the extension) of ENG-E2 125 μg/300 μg. Each cycle consisted of 21 days of vaginal ring use followed by 7 ring-free days.
11600|NCT02668783|O2|Outcome|Placebo|Participants received 4 (or 6 cycles if also participating in the extension) of placebo. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
11701|NCT02665260|E1|Reported Event|Cantharidin|Subjects treated with topical cantharidin 0.7% without occlusion
11601|NCT02668783|O1|Outcome|ENG-E2 125 μg/300 μg|Participants received 4 (or 6 cycles if also participating in the extension) of ENG-E2 125 μg/300 μg. Each cycle consisted of 21 days of vaginal ring use followed by 7 ring-free days.
11602|NCT02668783|O2|Outcome|Placebo|Participants received 4 (or 6 cycles if also participating in the extension) of placebo. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
11603|NCT02668783|O1|Outcome|ENG-E2 125 μg/300 μg|Participants received 4 (or 6 cycles if also participating in the extension) of ENG-E2 125 μg/300 μg. Each cycle consisted of 21 days of vaginal ring use followed by 7 ring-free days.
11604|NCT02668783|O2|Outcome|Placebo|Participants received 4 (or 6 cycles if also participating in the extension) of placebo. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
11605|NCT02668783|O1|Outcome|ENG-E2 125 μg/300 μg|Participants received 4 (or 6 cycles if also participating in the extension) of ENG-E2 125 μg/300 μg. Each cycle consisted of 21 days of vaginal ring use followed by 7 ring-free days.
11606|NCT02668783|E2|Reported Event|Placebo|Participants received 4 (or 6 cycles if also participating in the extension) of placebo. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
11607|NCT02668783|E1|Reported Event|ENG-E2 125 Microgram/300 Microgram|Participants received 4 (or 6 cycles if also participating in the extension) of ENG-E2 125 μg/300 μg. Each cycle consisted of 21 days of vaginal ring use followed by 7 ring-free days.
11608|NCT02667821|B1|Baseline|Intervention Group|Each participant will undergo three separate test maneuvers. Neutral (0° rotation) neck position (condition 1) will be followed by block randomization between maximum voluntary rotation (condition 2) and a high-velocity-low-amplitude cervical manipulation targeted at C1-C2 (condition 3). Conditions 1 and 2 will be held for 1 minute before returning to neutral alignment. For the manipulation, the head will be repositioned at neutrality immediate. An experienced practitioner will perform the manipulation on the adjustable and pivotal MRI bed. After each condition, MRI of the upper neck and cerebrum for perfusion and blood flow will ensue.
11609|NCT02667821|P1|Participant Flow|Intervention Group|Participants included in the experimental arm will be adults aged 18 years and older with chronic/recurrent neck pain Grade II who have been prescribed cervical manipulation for treatment of their condition. Each participant will undergo three separate test maneuvers. Neutral (0° rotation) neck position (condition 1) will be followed by block randomization between maximum voluntary rotation (condition 2) and a high-velocity-low-amplitude cervical manipulation targeted at C1-C2 (condition 3). Conditions 1 and 2 will be held for 1 minute before returning to neutral alignment. For the manipulation, the head will be repositioned at neutrality immediate. An experienced practitioner will perform the manipulation on the adjustable and pivotal MRI bed. After each condition, MRI of the upper neck and cerebrum for perfusion and blood flow will ensue.
11610|NCT02667821|O1|Outcome|Intervention Group|Participants included in the experimental arm will be adults aged 18 years and older with chronic/recurrent neck pain Grade II who have been prescribed cervical manipulation for treatment of their condition. Each participant will undergo three separate test maneuvers. Neutral (0° rotation) neck position (condition 1) will be followed by block randomization between maximum voluntary rotation (condition 2) and a high-velocity-low-amplitude cervical manipulation targeted at C1-C2 (condition 3). Conditions 1 and 2 will be held for 1 minute before returning to neutral alignment. For the manipulation, the head will be repositioned at neutrality immediate. An experienced practitioner will perform the manipulation on the adjustable and pivotal MRI bed. After each condition, MRI of the upper neck and cerebrum for perfusion and blood flow will ensue.
11611|NCT02667821|O1|Outcome|Intervention Group|"Participants included in the experimental arm will be adults aged 18 years and older with chronic neck pain who have been prescribed cervical manipulation for treatment of their condition. Each participant will undergo three separate test maneuvers. Each participant will begin with neutral cervical spine as a standard natural control, followed by block randomization between maximum voluntary rotation of the cervical spine and one cervical manipulation. Please see Intervention section for a detailed description.~Head positions and spinal manipulation: Each participant will undergo three separate test maneuvers. Neutral (0° rotation) neck position (condition 1) will be followed by block randomization between maximum voluntary rotation (condition 2) and a high-velocity-low-amplitude cervical manipulation targeted at C1-C2 (condition 3). Conditions 1 and 2 will be held fo"
11612|NCT02667821|O1|Outcome|Intervention Group|Participants included in the experimental arm will be adults aged 18 years and older with chronic/recurrent neck pain Grade II who have been prescribed cervical manipulation for treatment of their condition. Each participant will undergo three separate test maneuvers. Neutral (0° rotation) neck position (condition 1) will be followed by block randomization between maximum voluntary rotation (condition 2) and a high-velocity-low-amplitude cervical manipulation targeted at C1-C2 (condition 3). Conditions 1 and 2 will be held for 1 minute before returning to neutral alignment. For the manipulation, the head will be repositioned at neutrality immediate. An experienced practitioner will perform the manipulation on the adjustable and pivotal MRI bed. After each condition, MRI of the upper neck and cerebrum for perfusion and blood flow will ensue.
11613|NCT02667821|E1|Reported Event|Intervention Group|Participants included in the experimental arm will be adults aged 18 years and older with chronic/recurrent neck pain Grade II who have been prescribed cervical manipulation for treatment of their condition. Head positions and spinal manipulation: Each participant will undergo three separate test maneuvers. Neutral (0° rotation) neck position (condition 1) will be followed by block randomization between maximum voluntary rotation (condition 2) and a high-velocity-low-amplitude cervical manipulation targeted at C1-C2 (condition 3). Conditions 1 and 2 will be held for 1 minute before returning to neutral alignment. For the manipulation, the head will be repositioned at neutrality immediate. An experienced practitioner will perform the manipulation on the adjustable and pivotal MRI bed. After each condition, MRI of the upper neck and cerebrum for perfusion and blood flow will ensue.
11614|NCT02667704|B1|Baseline|Nintedanib (Reference (R)) / Bosentan+Nintedanib (Test (T))|Subject received single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 1 of period 1 and then multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 1 to 8 of period 2 plus single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 7 of period 2 administered orally with 240 millilitre (mL) of water
11702|NCT02665221|B3|Baseline|Total|Total of all reporting groups
11703|NCT02665221|B2|Baseline|Treatment Group|Topical Preparation H arm: Preparation H (phenylephrine) treatment first full dose incidence injection site reaction.
11615|NCT02667704|P1|Participant Flow|Nintedanib (Reference (R)) / Bosentan+Nintedanib (Test (T))|Subject received single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 1 of period 1 and then multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 1 to 8 of period 2 plus single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 7 of period 2 administered orally with 240 millilitre (mL) of water
11616|NCT02667704|O2|Outcome|Bosentan+Nintedanib (T)|Subject received multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 1 to 8 plus single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 7 administered orally with 240 mL of water
11617|NCT02667704|O1|Outcome|Nintedanib (R)|Subject received single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 1 administered orally with 240 millilitre (mL) of water.
11618|NCT02667704|O2|Outcome|Bosentan+Nintedanib (T)|Subject received multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 1 to 8 plus single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 7 administered orally with 240 mL of water
11619|NCT02667704|O1|Outcome|Nintedanib (R)|Subject received single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 1 administered orally with 240 millilitre (mL) of water.
11620|NCT02667704|O2|Outcome|Bosentan+Nintedanib (T)|Subject received multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 1 to 8 plus single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 7 administered orally with 240 mL of water
11621|NCT02667704|O1|Outcome|Nintedanib (R)|Subject received single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 1 administered orally with 240 millilitre (mL) of water.
11622|NCT02667704|E3|Reported Event|Bosentan+Nintedanib (T)|Subject received multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 7 and 8 of period 2 plus single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 7 administered orally with 240 mL of water
11623|NCT02667704|E2|Reported Event|Bosentan|Subject received multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 1 to 6 of period 2 administered orally with 240 mL of water
11624|NCT02667704|E1|Reported Event|Nintedanib (R)|Subject received single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 1 of period 1 administered orally with 240 millilitre (mL) of water.
11625|NCT02667288|B1|Baseline|A-101 Solution|"A-101 Solution 40% administered topically for a maximum of 4 treatment visits~A-101 Solution"
11626|NCT02667288|P1|Participant Flow|A-101 Solution|"A-101 Solution 40% administered topically for a maximum of 4 treatment visits~A-101 Solution"
11627|NCT02667288|O1|Outcome|A-101 Solution|"A-101 Solution 40% administered topically for a maximum of 4 treatment visits~A-101 Solution"
11628|NCT02667288|O1|Outcome|A-101 Solution|"A-101 Solution 40% administered topically for a maximum of 4 treatment visits~A-101 Solution"
11629|NCT02667288|E1|Reported Event|A-101 Solution|"A-101 Solution 40% administered topically for a maximum of 4 treatment visits~A-101 Solution"
11630|NCT02667275|B3|Baseline|Total|Total of all reporting groups
11631|NCT02667275|B2|Baseline|Vehicle Solution|"Vehicle Solution administered once~Vehicle Solution: Placebo"
11632|NCT02667275|B1|Baseline|A-101 Solution|"A-101 Solution 40% administered once~A-101 Solution"
11633|NCT02667275|P2|Participant Flow|Vehicle Solution|"Vehicle Solution administered once~Vehicle Solution: Placebo"
11634|NCT02667275|P1|Participant Flow|A-101 Solution|"A-101 Solution 40% administered once~A-101 Solution"
11635|NCT02667275|O2|Outcome|Vehicle Solution|"Vehicle Solution administered once~Vehicle Solution: Placebo"
11636|NCT02667275|O1|Outcome|A-101 Solution|"A-101 Solution 40% administered once~A-101 Solution"
11637|NCT02667275|O2|Outcome|Vehicle Solution|"Vehicle Solution administered once~Vehicle Solution: Placebo"
11638|NCT02667275|O1|Outcome|A-101 Solution|"A-101 Solution 40% administered once~A-101 Solution"
11639|NCT02667275|E2|Reported Event|Vehicle Solution|"Vehicle Solution administered once~Vehicle Solution: Placebo"
11640|NCT02667275|E1|Reported Event|A-101 Solution|"A-101 Solution 40% administered once~A-101 Solution"
11641|NCT02667236|B3|Baseline|Total|Total of all reporting groups
11642|NCT02667236|B2|Baseline|Vehicle Solution|"Vehicle Solution applied topically~Vehicle Solution: Placebo"
11643|NCT02667236|B1|Baseline|A-101 Solution|"A-101 Solution 40% applied topically~A-101 Solution: Active Drug"
11644|NCT02667236|P2|Participant Flow|Vehicle Solution|"Vehicle Solution applied topically~Vehicle Solution: Placebo"
11645|NCT02667236|P1|Participant Flow|A-101 Solution|"A-101 Solution 40% applied topically~A-101 Solution: Active Drug"
11646|NCT02667236|O2|Outcome|Vehicle Solution|"Vehicle Solution applied topically~Vehicle Solution: Placebo"
11647|NCT02667236|O1|Outcome|A-101 Solution|"A-101 Solution 40% applied topically~A-101 Solution: Active Drug"
11648|NCT02667236|O2|Outcome|Vehicle Solution|"Vehicle Solution applied topically~Vehicle Solution: Placebo"
11649|NCT02667236|O1|Outcome|A-101 Solution|"A-101 Solution 40% applied topically~A-101 Solution: Active Drug"
11650|NCT02667236|E2|Reported Event|Vehicle Solution|"Vehicle Solution applied topically~Vehicle Solution: Placebo"
11651|NCT02667236|E1|Reported Event|A-101 Solution|"A-101 Solution 40% applied topically~A-101 Solution: Active Drug"
11652|NCT02666560|B1|Baseline|All Study Participants|"Participants performed a functional task with auditory cueing set at self paced cadence and 20% above self paced cadence.~Auditory Cueing: This was delivered by a metronome producing a beat which was set at the participant's baseline cadence or 20% above baseline cadence.~This was a crossover design where participants completed both arms in the trial."
11653|NCT02666560|P2|Participant Flow|Cueing at 20% Above Self Paced Cadence Then Self Based Cadence|"Participants performed a functional task with auditory cueing set at 20% above self paced cadence. Five days following participants performed a functional task with auditory cueing set at self paced cadence.~Auditory Cueing: This was delivered by a metronome, which was set at a beat frequency rate 20% above baseline cadence or that matched the participant's baseline cadence."
11704|NCT02665221|B1|Baseline|Control Group|No Treatment Arm: Participants randomized to the control group will have no topical treatment at the injection site of the first full dose of Plegridy.
11705|NCT02665221|P2|Participant Flow|Treatment Group|Topical Preparation H arm: Preparation H (phenylephrine) treatment first full dose incidence injection site reaction.
11654|NCT02666560|P1|Participant Flow|Cueing Self Paced Then Cueing 20% Above Self Paced Cadence|"Participants performed a functional task with auditory cueing set at self paced cadence. Five days following participants performed a functional task with auditory cueing set at 20% above self paced cadence.~Auditory Cueing: This was was delivered by a metronome, which was set at a beat frequency rate that matched the participant's baseline cadence or 20% above baseline cadence."
11655|NCT02666560|O2|Outcome|AC20|Auditory cueing at 20% above self paced cadence
11656|NCT02666560|O1|Outcome|ACSC|Auditory cueing at self paced cadence
11657|NCT02666560|O2|Outcome|AC20|Auditory cueing at 20% above self paced cadence
11658|NCT02666560|O1|Outcome|ACSC|Auditory cueing at self paced cadence
11659|NCT02666560|O2|Outcome|AC20|Auditory cueing at 20% above self paced cadence
11660|NCT02666560|O1|Outcome|ACSC|Auditory cueing at self paced cadence
11661|NCT02666560|O2|Outcome|AC20|Auditory cueing at 20% above self paced cadence
11662|NCT02666560|O1|Outcome|ACSC|Auditory cueing at self paced cadence
11663|NCT02666560|O2|Outcome|AC20|Auditory cueing at 20% above self paced cadence
11664|NCT02666560|O1|Outcome|ACSC|Auditory cueing at self paced cadence
11665|NCT02666560|O2|Outcome|AC20|Auditory cueing set at 20% above self paced cadence
11666|NCT02666560|O1|Outcome|ACSC|Auditory cueing at self paced cadence
11667|NCT02666560|E2|Reported Event|Cueing at 20% Above Self Paced Cadence|"Participants performed a functional task with auditory cueing set at 20% above self paced cadence whilst performing a functional task.~Auditory Cueing: Auditory cueing set at different frequency rates"
11668|NCT02666560|E1|Reported Event|Auditory Cueing at Self Paced Cadence|"Participants performed a functional task with auditory cueing set at self paced cadence.~Auditory Cueing: Auditory cueing set at different frequency rates"
11669|NCT02666222|B1|Baseline|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
11670|NCT02666222|P1|Participant Flow|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
11671|NCT02666222|O1|Outcome|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
11672|NCT02666222|O1|Outcome|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
11673|NCT02666222|O1|Outcome|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
11674|NCT02666222|O1|Outcome|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
11675|NCT02666222|O1|Outcome|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
11676|NCT02666222|E1|Reported Event|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
11677|NCT02665455|B1|Baseline|Intervention|"FreeStyle Libre Flash Glucose Monitoring System~FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System masked for 14 days.~During these 14 days subjects will be asked to perform 4 blood glucose tests (pre-meals and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
11678|NCT02665455|P1|Participant Flow|Intervention|"FreeStyle Libre Flash Glucose Monitoring System~FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System masked for 14 days.~During these 14 days subjects will be asked to perform 4 blood glucose tests (pre-meals and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
11679|NCT02665455|O1|Outcome|Intervention|"FreeStyle Libre Flash Glucose Monitoring System~FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System masked for 14 days.~During these 14 days subjects will be asked to perform 4 blood glucose tests (pre-meals and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
11680|NCT02665455|E1|Reported Event|Intervention|"FreeStyle Libre Flash Glucose Monitoring System~FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System masked for 14 days.~During these 14 days subjects will be asked to perform 4 blood glucose tests (pre-meals and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
11681|NCT02665260|B5|Baseline|Total|Total of all reporting groups
11682|NCT02665260|B4|Baseline|Placebo With Occlusion|Patients treated with placebo vehicle with occlusion
11683|NCT02665260|B3|Baseline|Placebo|Patients treated with placebo without occlusion
11684|NCT02665260|B2|Baseline|Cantharidin With Occlusion|Patients treated with 0.7% topical cantharidin with occlusion
11685|NCT02665260|B1|Baseline|Cantharidin|Patients treated with 0.7% topical cantharidin without occlusion
11686|NCT02665260|P4|Participant Flow|Placebo Without Occlusion|Patients treated with placebo without conclusion
11687|NCT02665260|P3|Participant Flow|Placebo With Occlusion|Patients treated with placebo and occlusion
11688|NCT02665260|P2|Participant Flow|Cantharidin Without Occlusion|Patients treated with cantharidin 0.7% topical without occlusion
11689|NCT02665260|P1|Participant Flow|Cantharidin With Occlusion|Patients treated with cantharidin 0.7% topical with occlusion
11690|NCT02665260|O4|Outcome|Placebo With Occlusion|Patients treated with placebo vehicle with occlusion
11691|NCT02665260|O3|Outcome|Placebo|Patients treated with placebo without occlusion
11692|NCT02665260|O2|Outcome|Cantharidin With Occlusion|Patients treated with 0.7% topical cantharidin with occlusion
11693|NCT02665260|O1|Outcome|Cantharidin|Patients treated with 0.7% topical cantharidin without occlusion
11694|NCT02665260|O4|Outcome|Placebo Without Occlusion|Patients treated with placebo without conclusion
11695|NCT02665260|O3|Outcome|Placebo With Occlusion|Patients treated with placebo and occlusion
11696|NCT02665260|O2|Outcome|Cantharidin Without Occlusion|Patients treated with cantharidin 0.7% topical without occlusion
11697|NCT02665260|O1|Outcome|Cantharidin With Occlusion|Patients treated with cantharidin 0.7% topical with occlusion
11698|NCT02665260|E4|Reported Event|Placebo With Occlusion|Subjects treated with placebo with occlusion
11699|NCT02665260|E3|Reported Event|Placebo|Subjects treated with placebo without occlusion
11700|NCT02665260|E2|Reported Event|Cantharidin With Occlusion|Subjects treated with topical cantharidin 0.7% with occlusion
17727|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
11706|NCT02665221|P1|Participant Flow|Control Group|No Treatment Arm: Participants randomized to the control group will have no topical treatment at the injection site of the first full dose of Plegridy.
11707|NCT02665221|O2|Outcome|Treatment Group|Topical Preparation H arm: Preparation H (phenylephrine) treatment first full dose incidence injection site reaction.
11708|NCT02665221|O1|Outcome|Control Group|No Treatment Arm: Participants randomized to the control group will have no topical treatment at the injection site of the first full dose of Plegridy.
11709|NCT02665221|O2|Outcome|Treatment Group|Topical Preparation H arm: Preparation H (phenylephrine) treatment first full dose incidence injection site reaction.
11710|NCT02665221|O1|Outcome|Control Group|No Treatment Arm: Participants randomized to the control group will have no topical treatment at the injection site of the first full dose of Plegridy.
11711|NCT02665221|O2|Outcome|Treatment Group|Topical Preparation H arm: Preparation H (phenylephrine) treatment first full dose incidence injection site reaction.
11712|NCT02665221|O1|Outcome|Control Group|No Treatment Arm: Participants randomized to the control group will have no topical treatment at the injection site of the first full dose of Plegridy.
11713|NCT02665221|O2|Outcome|Treatment Group|Topical Preparation H arm: Preparation H (phenylephrine) treatment first full dose incidence injection site reaction.
11714|NCT02665221|O1|Outcome|Control Group|No Treatment Arm: Participants randomized to the control group will have no topical treatment at the injection site of the first full dose of Plegridy.
11715|NCT02665221|E2|Reported Event|Treatment Group|Topical Preparation H arm: Preparation H (phenylephrine) treatment first full dose incidence injection site reaction.
11716|NCT02665221|E1|Reported Event|Control Group|No Treatment Arm: Participants randomized to the control group will have no topical treatment at the injection site of the first full dose of Plegridy.
11717|NCT02664987|B1|Baseline|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
11718|NCT02664987|P1|Participant Flow|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
11719|NCT02664987|O1|Outcome|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
11720|NCT02664987|O1|Outcome|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
11721|NCT02664987|O1|Outcome|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
11722|NCT02664987|O1|Outcome|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
11723|NCT02664987|O1|Outcome|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
11724|NCT02664987|O1|Outcome|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
11725|NCT02664987|E1|Reported Event|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
11726|NCT02664610|B3|Baseline|Total|Total of all reporting groups
11727|NCT02664610|B2|Baseline|Text Messages, Hypertensive|"Participants who have high blood pressure, who are randomized to receive text messages.~Text Messaging: hypertensive participants will be randomized to receive tailored, motivational text messages"
11728|NCT02664610|B1|Baseline|No Text Messages, Hypertensive|Participants who have high blood pressure, who are randomized to health information (do not receive text messages).
11729|NCT02664610|P2|Participant Flow|Text Messages, Hypertensive|"Participants who have high blood pressure, who are randomized to receive text messages.~Text Messaging: hypertensive participants will be randomized to receive tailored, motivational text messages"
11730|NCT02664610|P1|Participant Flow|No Text Messages, Hypertensive|Participants who have high blood pressure, who are randomized to health information (do not receive text messages).
11731|NCT02664610|O2|Outcome|Text Messages, Hypertensive|"Participants who have high blood pressure, who are randomized to receive text messages.~Text Messaging: hypertensive participants will be randomized to receive tailored, motivational text messages"
11732|NCT02664610|O1|Outcome|No Text Messages, Hypertensive|Participants who have high blood pressure, who are randomized to health information (do not receive text messages).
11733|NCT02664610|O2|Outcome|Text Messages, Hypertensive|"Participants who have high blood pressure, who are randomized to receive text messages.~Text Messaging: hypertensive participants will be randomized to receive tailored, motivational text messages"
11734|NCT02664610|O1|Outcome|No Text Messages, Hypertensive|Participants who have high blood pressure, who are randomized to health information (do not receive text messages).
11735|NCT02664610|E2|Reported Event|Text Messages, Hypertensive|"Participants who have high blood pressure, who are randomized to receive text messages.~Text Messaging: hypertensive participants will be randomized to receive tailored, motivational text messages"
11736|NCT02664610|E1|Reported Event|No Text Messages, Hypertensive|Participants who have high blood pressure, who are randomized to health information (do not receive text messages).
11737|NCT02664532|B3|Baseline|Total|Total of all reporting groups
11738|NCT02664532|B2|Baseline|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Macintosh group: Macintosh blade was used for laryngoscopy"
11739|NCT02664532|B1|Baseline|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Miller group: Miller blade was used for laryngoscopy"
11740|NCT02664532|P2|Participant Flow|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Macintosh group: Macintosh blade was used for laryngoscopy"
11762|NCT02664311|O1|Outcome|Conventional Ventilation|"Patients receiving conventional ventilation for the duration of this study~Conventional ventilation: Conventional ventilator - control arm"
20058|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
11741|NCT02664532|P1|Participant Flow|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Miller group: Miller blade was used for laryngoscopy"
11742|NCT02664532|O2|Outcome|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Macintosh group: Macintosh blade was used for laryngoscopy"
11743|NCT02664532|O1|Outcome|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Miller group: Miller blade was used for laryngoscopy"
11744|NCT02664532|O2|Outcome|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Macintosh group: Macintosh blade was used for laryngoscopy"
11745|NCT02664532|O1|Outcome|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Miller group: Miller blade was used for laryngoscopy"
11746|NCT02664532|O2|Outcome|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Macintosh group: Macintosh blade was used for laryngoscopy"
11747|NCT02664532|O1|Outcome|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Miller group: Miller blade was used for laryngoscopy"
11748|NCT02664532|O2|Outcome|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Macintosh group: Macintosh blade was used for laryngoscopy"
11749|NCT02664532|O1|Outcome|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Miller group: Miller blade was used for laryngoscopy"
11750|NCT02664532|E2|Reported Event|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Macintosh group: Macintosh blade was used for laryngoscopy"
11751|NCT02664532|E1|Reported Event|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Miller group: Miller blade was used for laryngoscopy"
11752|NCT02664311|B3|Baseline|Total|Total of all reporting groups
11753|NCT02664311|B2|Baseline|Jet Ventilation|"Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium~Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study"
11754|NCT02664311|B1|Baseline|Conventional Ventilation|"Patients receiving conventional ventilation for the duration of this study~Conventional ventilation: Conventional ventilator - control arm"
11755|NCT02664311|P2|Participant Flow|Jet Ventilation|"Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium~Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study"
11756|NCT02664311|P1|Participant Flow|Conventional Ventilation|"Patients receiving conventional ventilation for the duration of this study~Conventional ventilation: Conventional ventilator - control arm"
11757|NCT02664311|O2|Outcome|Jet Ventilation|"Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium~Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study"
11758|NCT02664311|O1|Outcome|Conventional Ventilation|"Patients receiving conventional ventilation for the duration of this study~Conventional ventilation: Conventional ventilator - control arm"
11759|NCT02664311|O2|Outcome|Jet Ventilation|"Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium~Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study"
11760|NCT02664311|O1|Outcome|Conventional Ventilation|"Patients receiving conventional ventilation for the duration of this study~Conventional ventilation: Conventional ventilator - control arm"
11761|NCT02664311|O2|Outcome|Jet Ventilation|"Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium~Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study"
11845|NCT02661594|O1|Outcome|APD421 5 mg|Intravenous amisulpride 5 mg: infusion over 2 minutes
11763|NCT02664311|E2|Reported Event|Jet Ventilation|"Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium~Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study"
11764|NCT02664311|E1|Reported Event|Conventional Ventilation|"Patients receiving conventional ventilation for the duration of this study~Conventional ventilation: Conventional ventilator - control arm"
11765|NCT02663453|B3|Baseline|Total|Total of all reporting groups
11766|NCT02663453|B2|Baseline|Control Group|"pure soybean oil lipid emulsion(intralipid) was administered at a dose of 1gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~pure soybean oil lipid emulsion: Lipids were first administered at a dose of 1gm/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached."
11767|NCT02663453|B1|Baseline|Study Group|"multicomponent lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~multicomponent lipid emulsion: Lipids were first administered at a dose of 1gm/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached."
11768|NCT02663453|P2|Participant Flow|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
11769|NCT02663453|P1|Participant Flow|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
11770|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
11771|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
11772|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
11773|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
11774|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
11775|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
11846|NCT02661594|E4|Reported Event|Moxifloxacin|"Oral moxifloxacin 400 mg tablet administered once (not blinded)~Moxifloxacin: Positive control for assay sensitivity"
11776|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
11777|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
11778|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
11779|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
11780|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
11781|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
11782|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
11783|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
11784|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
11785|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
11786|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
11787|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
11788|NCT02663453|E2|Reported Event|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
11789|NCT02663453|E1|Reported Event|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
11790|NCT02663232|B1|Baseline|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
11791|NCT02663232|P1|Participant Flow|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
11792|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
11793|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
11794|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
11795|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
11796|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
11797|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
11798|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
11799|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
11800|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
11801|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
11802|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
11803|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
11804|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
11805|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
11806|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
11807|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
11808|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
11809|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
11810|NCT02663232|E1|Reported Event|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
11811|NCT02662608|B1|Baseline|Brontictuzumab|Brontictuzumab 1.5 mg/Kg intravenously every 3 weeks.
11812|NCT02662608|P1|Participant Flow|Brontictuzumab|Brontictuzumab 1.5 mg/Kg intravenously every 3 weeks.
11813|NCT02662608|O1|Outcome|Brontictuzumab|Brontictuzumab 1.5 mg/Kg intravenously every 3 weeks.
11814|NCT02662608|E1|Reported Event|Brontictuzumab|Brontictuzumab 1.5 mg/Kg intravenously every 3 weeks.
11815|NCT02662556|B1|Baseline|Sufentanil Sublingual Tablet (SST) 30 mcg|"Sufentanil sublingual tablet (SST) 30 mcg~Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours."
11816|NCT02662556|P1|Participant Flow|Sufentanil Sublingual Tablet (SST) 30 mcg|"Sufentanil sublingual tablet (SST) 30 mcg~Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours."
11817|NCT02662556|O1|Outcome|Sufentanil Sublingual Tablet (SST) 30 mcg|"Sufentanil sublingual tablet (SST) 30 mcg~Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours."
11818|NCT02662556|O1|Outcome|Sufentanil Sublingual Tablet (SST) 30 mcg|"Sufentanil sublingual tablet (SST) 30 mcg~Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours."
11819|NCT02662556|O1|Outcome|Sufentanil Sublingual Tablet (SST) 30 mcg|"Sufentanil sublingual tablet (SST) 30 mcg~Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours."
11820|NCT02662556|O1|Outcome|Sufentanil Sublingual Tablet (SST) 30 mcg|"Sufentanil sublingual tablet (SST) 30 mcg~Sufentanil sublingual tablet (SST) 30 mcg: one sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours."
11821|NCT02662556|E1|Reported Event|Sufentanil Sublingual Tablet (SST) 30 mcg|"Sufentanil sublingual tablet (SST) 30 mcg~Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours."
11822|NCT02662387|B3|Baseline|Total|Total of all reporting groups
11823|NCT02662387|B2|Baseline|HFNC and External Nasal Dilator (END)|"high flow nasal cannula and external nasal dilator~External nasal dilator (END): Applying External nasal dilator as adjuvant to high flow oxygen~High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Subjects: 28"
11824|NCT02662387|B1|Baseline|High Flow Nasal Cannula (HFNC)|"Non-invasive positive pressure ventilation~High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Subjects: 27"
11825|NCT02662387|P2|Participant Flow|HFNC and External Nasal Dilator (END)|"high flow nasal cannula and external nasal dilator~External nasal dilator (END): Applying External nasal dilator as adjuvant to high flow oxygen~High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Subjects: 28"
11826|NCT02662387|P1|Participant Flow|High Flow Nasal Cannula (HFNC)|"Non-invasive positive pressure ventilation~High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Subjects: 27"
11827|NCT02662387|O2|Outcome|HFNC With END|High flow nasal cannula with external nasal dilator
11828|NCT02662387|O1|Outcome|HFNC Group|High flow nasal cannula alone without external nasal dilator
11829|NCT02662387|O2|Outcome|HFNC and External Nasal Dilator (END)|"high flow nasal cannula and external nasal dilator~External nasal dilator (END): Applying External nasal dilator as adjuvant to high flow oxygen~High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Lower MBSS"
11830|NCT02662387|O1|Outcome|High Flow Nasal Cannula (HFNC)|"Non-invasive positive pressure ventilation~High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Higher MBSS"
11831|NCT02662387|E2|Reported Event|HFNC and External Nasal Dilator (END)|"high flow nasal cannula and external nasal dilator~External nasal dilator (END): Applying External nasal dilator as adjuvant to high flow oxygen~High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation No adverse events"
11832|NCT02662387|E1|Reported Event|High Flow Nasal Cannula (HFNC)|"Non-invasive positive pressure ventilation~High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation No adverse events"
11833|NCT02661594|B5|Baseline|Total|Total of all reporting groups
11834|NCT02661594|B4|Baseline|DCBA|D: Placebo C: Moxifloxacin 400 mg B: APD421 40 mg A: APD421 5 mg
11835|NCT02661594|B3|Baseline|CADB|C: Moxifloxacin 400 mg A: APD421 5 mg D: Placebo B: APD421 40 mg
11836|NCT02661594|B2|Baseline|BDAC|B: APD421 40 mg; D: Placebo. A: APD421 5 mg C: Moxifloxacin 400 mg.
11837|NCT02661594|B1|Baseline|ABCD|A: APD421 5 mg followed by B: APD421 40 mg; C: Moxifloxacin 400 mg; D: Placebo.
11838|NCT02661594|P4|Participant Flow|DCBA|D: Placebo C: Moxifloxacin 400 mg B: APD421 40 mg A: APD421 5 mg
11839|NCT02661594|P3|Participant Flow|CADB|C: Moxifloxacin 400 mg A: APD421 5 mg D: Placebo B: APD421 40 mg
11840|NCT02661594|P2|Participant Flow|BDAC|B: APD421 40 mg; D: Placebo. A: APD421 5 mg C: Moxifloxacin 400 mg.
11841|NCT02661594|P1|Participant Flow|ABCD|A: APD421 5 mg followed by B: APD421 40 mg; C: Moxifloxacin 400 mg; D: Placebo
11842|NCT02661594|O4|Outcome|Placebo|Intravenous placebo: two infusions in parallel, one over 2 minutes, one over 8 minutes
11843|NCT02661594|O3|Outcome|Moxifloxacin|"Oral moxifloxacin 400 mg tablet administered once (not blinded)~Moxifloxacin: Positive control for assay sensitivity"
11844|NCT02661594|O2|Outcome|APD421 40 mg;|Intravenous amisulpride 40 mg: infusion over 8 minutes
11847|NCT02661594|E3|Reported Event|Amisulpride 40 mg|"Intravenous amisulpride 40 mg: infusion over 8 minutes;~Intravenous placebo infused in parallel over 2 minutes~Amisulpride 40 mg: Supra-therapeutic dose of amisulpride"
11848|NCT02661594|E2|Reported Event|Amisulpride 5 mg|"Intravenous amisulpride 5 mg: infusion over 2 minutes; Intravenous placebo infused in parallel over 8 minutes~Amisulpride 5 mg: Therapeutic dose of amisulpride"
11849|NCT02661594|E1|Reported Event|Placebo|"Intravenous placebo: two infusions in parallel, one over 2 minutes, one over 8 minutes~Placebo: Placebo comparator to establish baseline for calculating change in QTcF"
11850|NCT02658461|B4|Baseline|Total|Total of all reporting groups
11851|NCT02658461|B3|Baseline|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11852|NCT02658461|B2|Baseline|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11853|NCT02658461|B1|Baseline|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11854|NCT02658461|P3|Participant Flow|Trastuzumab Intravenous (IV) Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 milligrams per kilogram (mg/kg) on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed greater than (>) 1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11855|NCT02658461|P2|Participant Flow|Trastuzumab Subcutaneous (SC) Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11856|NCT02658461|P1|Participant Flow|Trastuzumab Single-Use Injection Device|Participants with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC) received trastuzumab via single-use injection device as 600 milligrams (mg) on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11857|NCT02658461|O3|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11858|NCT02658461|O2|Outcome|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11859|NCT02658461|O1|Outcome|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11860|NCT02658461|O3|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11861|NCT02658461|O2|Outcome|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11862|NCT02658461|O1|Outcome|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11863|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11864|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11865|NCT02658461|O1|Outcome|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11866|NCT02658461|O1|Outcome|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11867|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11972|NCT02654145|B1|Baseline|Mepolizumab 100 mg SC|Eligible participants received mepolizumab 100 mg SC doses into the upper arm or thigh every 4 weeks over a period of 32 weeks, with the last dose administered at Week 28, along with their current maintenance therapy except omalizumab.
11868|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11869|NCT02658461|O1|Outcome|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11870|NCT02658461|O1|Outcome|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11871|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11872|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11873|NCT02658461|O1|Outcome|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11874|NCT02658461|O1|Outcome|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11875|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11876|NCT02658461|O1|Outcome|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11877|NCT02658461|O1|Outcome|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11878|NCT02658461|E3|Reported Event|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11879|NCT02658461|E2|Reported Event|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11880|NCT02658461|E1|Reported Event|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11881|NCT02658149|B3|Baseline|Total|Total of all reporting groups
11882|NCT02658149|B2|Baseline|Periarticular Local Anesthetic|"An anesthetic cocktail of four drugs (ropivacaine, epinephrine, ketorolac tromethamine, morphine) is injected at five locations at the surgical site to the surrounding tissues.~Epinephrine: 0.15 mg Epinephrine are injected as part of the drug cocktail~Morphine: 4 mg Morphine are injected as part of the drug cocktail~Ketorolac Tromethamine: 30 mg morphine are injected as part of the drug cocktail~Ropivacaine: 30 mL 0.5% Ropivicaine are injected as part of the drug cocktail"
11883|NCT02658149|B1|Baseline|Psoas Compartment Block|"After exposure anesthetic (Ropivacaine with NaCl) is introduced directly into the iliopsoas muscle, where it then spreads to the lumbar plexus (the nerves responsible for sensation around the surgical site).~Ropivacaine with NaCl: 50 mL (40 mL of 0.2% Ropivicaine and 10 mL of 0.9% NaCl) are administered into the psoas compartment"
11884|NCT02658149|P2|Participant Flow|Periarticular Local Anesthetic|"An anesthetic cocktail of four drugs (ropivacaine, epinephrine, ketorolac tromethamine, morphine) is injected at five locations at the surgical site to the surrounding tissues.~Epinephrine: 0.15 mg Epinephrine are injected as part of the drug cocktail~Morphine: 4 mg Morphine are injected as part of the drug cocktail~Ketorolac Tromethamine: 30 mg morphine are injected as part of the drug cocktail~Ropivacaine: 30 mL 0.5% Ropivicaine are injected as part of the drug cocktail"
11885|NCT02658149|P1|Participant Flow|Psoas Compartment Block|"After exposure anesthetic (Ropivacaine with NaCl) is introduced directly into the iliopsoas muscle, where it then spreads to the lumbar plexus (the nerves responsible for sensation around the surgical site).~Ropivacaine with NaCl: 50 mL (40 mL of 0.2% Ropivicaine and 10 mL of 0.9% NaCl) are administered into the psoas compartment"
11886|NCT02658149|O2|Outcome|Periarticular Local Anesthetic|"An anesthetic cocktail of four drugs (ropivacaine, epinephrine, ketorolac tromethamine, morphine) is injected at five locations at the surgical site to the surrounding tissues.~Epinephrine: 0.15 mg Epinephrine are injected as part of the drug cocktail~Morphine: 4 mg Morphine are injected as part of the drug cocktail~Ketorolac Tromethamine: 30 mg morphine are injected as part of the drug cocktail~Ropivacaine: 30 mL 0.5% Ropivicaine are injected as part of the drug cocktail"
12028|NCT02653495|B2|Baseline|Influenza Vaccine in Healthy Controls|"Influenza vaccine~Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3"
11887|NCT02658149|O1|Outcome|Psoas Compartment Block|"After exposure anesthetic (Ropivacaine with NaCl) is introduced directly into the iliopsoas muscle, where it then spreads to the lumbar plexus (the nerves responsible for sensation around the surgical site).~Ropivacaine with NaCl: 50 mL (40 mL of 0.2% Ropivicaine and 10 mL of 0.9% NaCl) are administered into the psoas compartment"
11888|NCT02658149|O2|Outcome|Periarticular Local Anesthetic|"An anesthetic cocktail of four drugs (ropivacaine, epinephrine, ketorolac tromethamine, morphine) is injected at five locations at the surgical site to the surrounding tissues.~Epinephrine: 0.15 mg Epinephrine are injected as part of the drug cocktail~Morphine: 4 mg Morphine are injected as part of the drug cocktail~Ketorolac Tromethamine: 30 mg morphine are injected as part of the drug cocktail~Ropivacaine: 30 mL 0.5% Ropivicaine are injected as part of the drug cocktail"
11889|NCT02658149|O1|Outcome|Psoas Compartment Block|"After exposure anesthetic (Ropivacaine with NaCl) is introduced directly into the iliopsoas muscle, where it then spreads to the lumbar plexus (the nerves responsible for sensation around the surgical site).~Ropivacaine with NaCl: 50 mL (40 mL of 0.2% Ropivicaine and 10 mL of 0.9% NaCl) are administered into the psoas compartment"
11890|NCT02658149|O2|Outcome|Periarticular Local Anesthetic|"An anesthetic cocktail of four drugs (ropivacaine, epinephrine, ketorolac tromethamine, morphine) is injected at five locations at the surgical site to the surrounding tissues.~Epinephrine: 0.15 mg Epinephrine are injected as part of the drug cocktail~Morphine: 4 mg Morphine are injected as part of the drug cocktail~Ketorolac Tromethamine: 30 mg morphine are injected as part of the drug cocktail~Ropivacaine: 30 mL 0.5% Ropivicaine are injected as part of the drug cocktail"
11891|NCT02658149|O1|Outcome|Psoas Compartment Block|"After exposure anesthetic (Ropivacaine with NaCl) is introduced directly into the iliopsoas muscle, where it then spreads to the lumbar plexus (the nerves responsible for sensation around the surgical site).~Ropivacaine with NaCl: 50 mL (40 mL of 0.2% Ropivicaine and 10 mL of 0.9% NaCl) are administered into the psoas compartment"
11892|NCT02658149|O2|Outcome|Periarticular Local Anesthetic|"An anesthetic cocktail of four drugs (ropivacaine, epinephrine, ketorolac tromethamine, morphine) is injected at five locations at the surgical site to the surrounding tissues.~Epinephrine: 0.15 mg Epinephrine are injected as part of the drug cocktail~Morphine: 4 mg Morphine are injected as part of the drug cocktail~Ketorolac Tromethamine: 30 mg morphine are injected as part of the drug cocktail~Ropivacaine: 30 mL 0.5% Ropivicaine are injected as part of the drug cocktail"
11893|NCT02658149|O1|Outcome|Psoas Compartment Block|"After exposure anesthetic (Ropivacaine with NaCl) is introduced directly into the iliopsoas muscle, where it then spreads to the lumbar plexus (the nerves responsible for sensation around the surgical site).~Ropivacaine with NaCl: 50 mL (40 mL of 0.2% Ropivicaine and 10 mL of 0.9% NaCl) are administered into the psoas compartment"
11894|NCT02658149|O2|Outcome|Periarticular Local Anesthetic|"An anesthetic cocktail of four drugs (ropivacaine, epinephrine, ketorolac tromethamine, morphine) is injected at five locations at the surgical site to the surrounding tissues.~Epinephrine: 0.15 mg Epinephrine are injected as part of the drug cocktail~Morphine: 4 mg Morphine are injected as part of the drug cocktail~Ketorolac Tromethamine: 30 mg morphine are injected as part of the drug cocktail~Ropivacaine: 30 mL 0.5% Ropivicaine are injected as part of the drug cocktail"
11895|NCT02658149|O1|Outcome|Psoas Compartment Block|"After exposure anesthetic (Ropivacaine with NaCl) is introduced directly into the iliopsoas muscle, where it then spreads to the lumbar plexus (the nerves responsible for sensation around the surgical site).~Ropivacaine with NaCl: 50 mL (40 mL of 0.2% Ropivicaine and 10 mL of 0.9% NaCl) are administered into the psoas compartment"
11896|NCT02658149|E2|Reported Event|Periarticular Local Anesthetic|"An anesthetic cocktail of four drugs (ropivacaine, epinephrine, ketorolac tromethamine, morphine) is injected at five locations at the surgical site to the surrounding tissues.~Epinephrine: 0.15 mg Epinephrine are injected as part of the drug cocktail~Morphine: 4 mg Morphine are injected as part of the drug cocktail~Ketorolac Tromethamine: 30 mg morphine are injected as part of the drug cocktail~Ropivacaine: 30 mL 0.5% Ropivicaine are injected as part of the drug cocktail"
11897|NCT02658149|E1|Reported Event|Psoas Compartment Block|"After exposure anesthetic (Ropivacaine with NaCl) is introduced directly into the iliopsoas muscle, where it then spreads to the lumbar plexus (the nerves responsible for sensation around the surgical site).~Ropivacaine with NaCl: 50 mL (40 mL of 0.2% Ropivicaine and 10 mL of 0.9% NaCl) are administered into the psoas compartment"
11898|NCT02657629|B3|Baseline|Total|Total of all reporting groups
11899|NCT02657629|B2|Baseline|Intermittent Bolus Feeding Regimen|"Enteral feedings given as intermittent bolus feedings for entire 24 hour period.~Intermittent Bolus Feeding Regimen: Intermittent bolus enteral feedings given after 3 hours for entire 24 hours period. Feedings given via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
11900|NCT02657629|B1|Baseline|Continuous Feeding Regimen|"Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.~Continuous Feeding Regimen: Nocturnal continuous enteral feedings given from 8pm-8am with intermittent bolus feedings every 3 hours between 11am and 5pm. Continuous feedings given via gavage (nasogastric tube, orogastric tube or gastrostomy tube) and intermittent bolus feeds via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
11901|NCT02657629|P2|Participant Flow|Intermittent Bolus Feeding Regimen|"Enteral feedings given as intermittent bolus feedings for entire 24 hour period.~Intermittent Bolus Feeding Regimen: Intermittent bolus enteral feedings given after 3 hours for entire 24 hours period. Feedings given via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
11902|NCT02657629|P1|Participant Flow|Continuous Feeding Regimen|"Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.~Continuous Feeding Regimen: Nocturnal continuous enteral feedings given from 8pm-8am with intermittent bolus feedings every 3 hours between 11am and 5pm. Continuous feedings given via gavage (nasogastric tube, orogastric tube or gastrostomy tube) and intermittent bolus feeds via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
11903|NCT02657629|O2|Outcome|Intermittent Bolus Feeding Regimen|"Enteral feedings given as intermittent bolus feedings for entire 24 hour period.~Intermittent Bolus Feeding Regimen: Intermittent bolus enteral feedings given after 3 hours for entire 24 hours period. Feedings given via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
12000|NCT02653872|O2|Outcome|AZD7986 + Verapamil|Participants received Verapamil (240 mg; extended release formulation) administered daily (1 hour before food) on Days 1 to 10 plus administration of a single dose of AZD7986 (25 mg) on Day 5 (1 hour before food).
11904|NCT02657629|O1|Outcome|Continuous Feeding Regimen|"Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.~Continuous Feeding Regimen: Nocturnal continuous enteral feedings given from 8pm-8am with intermittent bolus feedings every 3 hours between 11am and 5pm. Continuous feedings given via gavage (nasogastric tube, orogastric tube or gastrostomy tube) and intermittent bolus feeds via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
11905|NCT02657629|E2|Reported Event|Intermittent Bolus Feeding Regimen|"Enteral feedings given as intermittent bolus feedings for entire 24 hour period.~Intermittent Bolus Feeding Regimen: Intermittent bolus enteral feedings given after 3 hours for entire 24 hours period. Feedings given via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
11906|NCT02657629|E1|Reported Event|Continuous Feeding Regimen|"Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.~Continuous Feeding Regimen: Nocturnal continuous enteral feedings given from 8pm-8am with intermittent bolus feedings every 3 hours between 11am and 5pm. Continuous feedings given via gavage (nasogastric tube, orogastric tube or gastrostomy tube) and intermittent bolus feeds via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
11907|NCT02657538|B1|Baseline|All Study Participants|"35 participants with either initial caries and/or no carious lesion were included in this study.~The participants had to be at least 14 years old, in good health (ASA-Status 1) and they had to give their informed consent."
11908|NCT02657538|P1|Participant Flow|All Study Participants|"35 participants with either initial caries and/or no carious lesion were included in this study.~The participants had to be at least 14 years old, in good health (ASA-Status 1) and they had to give their informed consent."
11909|NCT02657538|O1|Outcome|All Study Participants|"35 participants with either initial caries and/or no carious lesion were included in this study.~The participants had to be at least 14 years old, in good health (ASA-Status 1) and they had to give their informed consent."
11910|NCT02657538|O2|Outcome|Visual Caries Detection + BW|"visual caries detection + bite wing radiography (BW): considered as gold standard in caries diagnostics.~Non invasive caries treatment: If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.~Invasive caries treatment: If the active comparator does detect cavitation, a composite restauration is placed~Visual examination and bitewing (BW) radiography: established diagnostic methods"
11911|NCT02657538|O1|Outcome|Near Infrared Transillumination|"Near infrared transillumination is applied for initial enamel caries lesion detection.~Non invasive caries treatment: If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.~Invasive caries treatment: If the active comparator does detect cavitation, a composite restauration is placed~Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany)"
11912|NCT02657538|E2|Reported Event|Visual Caries Detection + BW|"visual caries detection + bite wing radiography (BW): considered as gold standard in caries diagnostics.~Non invasive caries treatment: If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.~Invasive caries treatment: If the active comparator does detect cavitation, a composite restauration is placed~Visual examination and bitewing (BW) radiography: established diagnostic methods"
11913|NCT02657538|E1|Reported Event|Near Infrared Transillumination|"Near infrared transillumination is applied for initial enamel caries lesion detection.~Non invasive caries treatment: If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.~Invasive caries treatment: If the active comparator does detect cavitation, a composite restauration is placed~Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany)"
11914|NCT02657252|B3|Baseline|Total|Total of all reporting groups
11915|NCT02657252|B2|Baseline|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects~Polidocanol with Glucose: Sclerotherapy of telangiectasis in one lower limb."
11916|NCT02657252|B1|Baseline|Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects~Glucose: Sclerotherapy of telangiectasis in one lower limb."
11917|NCT02657252|P2|Participant Flow|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects~Polidocanol with Glucose: Sclerotherapy of telangiectasis in one lower limb."
11918|NCT02657252|P1|Participant Flow|Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects~Glucose: Sclerotherapy of telangiectasis in one lower limb."
11919|NCT02657252|O2|Outcome|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects~Polidocanol with Glucose: Sclerotherapy of telangiectasis in one lower limb."
11920|NCT02657252|O1|Outcome|Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects~Glucose: Sclerotherapy of telangiectasis in one lower limb."
11921|NCT02657252|O2|Outcome|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects~Polidocanol with Glucose: Sclerotherapy of telangiectasis in one lower limb."
11922|NCT02657252|O1|Outcome|Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects~Glucose: Sclerotherapy of telangiectasis in one lower limb."
11923|NCT02657252|O2|Outcome|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects~Polidocanol with Glucose: Sclerotherapy of telangiectasis in one lower limb."
11924|NCT02657252|O1|Outcome|Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects~Glucose: Sclerotherapy of telangiectasis in one lower limb."
11925|NCT02657252|E2|Reported Event|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects~Polidocanol with Glucose: Sclerotherapy of telangiectasis in one lower limb."
11926|NCT02657252|E1|Reported Event|Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects~Glucose: Sclerotherapy of telangiectasis in one lower limb."
11927|NCT02657031|B3|Baseline|Total|Total of all reporting groups
11928|NCT02657031|B2|Baseline|Study Arm|"This arm uses stud drug regime of Ketamine 0.3 mg/kg along with Ondansetron 4 mg IV plus Normal Sailing 500 cc bolus.~Ketamine: Ketamine 0.3 mg/kg IV~Ondansetron: Ondansetron 4 mg IV~Normal Saline: Normal Saline 500 cc IV Bolus"
11929|NCT02657031|B1|Baseline|Control Arm|"This arm uses standard of care treatment of prochlorperazine 10 mg IV along with diphenhydramine 25 mg IV plus Normal Sailine 500 cc bolus~Prochlorperazine: prochlorperazine 10 mg IV~Diphenhydromine: Diphenhydromine 25 mg IV~Normal Saline: Normal Saline 500 cc IV Bolus"
11930|NCT02657031|P2|Participant Flow|Study Arm|Ketamine and Ondansetron
11931|NCT02657031|P1|Participant Flow|Control Arm|Prochlorperazine and Diphenhydramine
11932|NCT02657031|O2|Outcome|Study Arm|Ketamine and Ondansetron
11933|NCT02657031|O1|Outcome|Control Arm|Prochlorperazine and Diphenhydramine
11934|NCT02657031|O2|Outcome|Study Arm|Ketamine and Ondansetron
11935|NCT02657031|O1|Outcome|Control Arm|Prochlorperazine and Diphenhydramine
11936|NCT02657031|O2|Outcome|Study Arm|Ketamine and Ondansetron
11937|NCT02657031|O1|Outcome|Control Arm|Prochlorperazine and Diphenhydramine
11938|NCT02657031|O2|Outcome|Study Arm|Ketamine and Ondansetron
11939|NCT02657031|O1|Outcome|Control Arm|Prochlorperazine and Diphenhydramine
11940|NCT02657031|O2|Outcome|Study Arm|Ketamine and Ondansetron
11941|NCT02657031|O1|Outcome|Control Arm|Prochlorperazine and Diphenhydramine
11942|NCT02657031|E2|Reported Event|Study Arm|Ketamine and Ondansetron
11943|NCT02657031|E1|Reported Event|Control Arm|Prochlorperazine and Diphenhydramine
11944|NCT02656485|B5|Baseline|Total|Total of all reporting groups
11945|NCT02656485|B4|Baseline|Placebo|"Placebo~Placebo: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
11946|NCT02656485|B3|Baseline|Dose III|"B244 dose strength III~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
11947|NCT02656485|B2|Baseline|Dose II|"B244 dose strength II~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
11948|NCT02656485|B1|Baseline|Dose I|"B244 dose strength I~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
11949|NCT02656485|P4|Participant Flow|Placebo|Placebo: 10 pumps of spray applied BID twice a day to the entire face for 14 days
11950|NCT02656485|P3|Participant Flow|Dose III|BB244 Dose III: 10 pumps of spray applied BID twice a day to the entire face for 14 days
11951|NCT02656485|P2|Participant Flow|Dose II|BB244 Dose II : 10 pumps of spray applied BID twice a day to the entire face for 14 days
11952|NCT02656485|P1|Participant Flow|Dose I|BB244 Dose I : 10 pumps of spray applied BID twice a day to the entire face for 14 days
11953|NCT02656485|O2|Outcome|Placebo|Placebo Arm
11954|NCT02656485|O1|Outcome|Pooled Active Doses|Pooled Active Doses (Doses I, II, III)
11955|NCT02656485|O4|Outcome|Placebo|"Placebo~Placebo: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
11956|NCT02656485|O3|Outcome|Dose III|"B244 dose III~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
11957|NCT02656485|O2|Outcome|Dose II|"B244 dose II~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
11958|NCT02656485|O1|Outcome|Dose I|"B244 dose I~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
11959|NCT02656485|E4|Reported Event|Placebo|"Placebo~Placebo: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
11960|NCT02656485|E3|Reported Event|Dose III|"B244 Dose 3 (dose level [cells/mL] 80,000,000,000)~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
11961|NCT02656485|E2|Reported Event|Dose II|"B244 Dose 2 (dose level [cells/mL] 40,000,000,000)~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
11962|NCT02656485|E1|Reported Event|Dose I|"B244 Dose 1 (dose level [cells/mL] 20,000,000,000)~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
11963|NCT02656160|B1|Baseline|All Analyzed Participants|All participants who were randomized, completed both study nights, and were included in the analysis.
11964|NCT02656160|P2|Participant Flow|Placebo First, 4-AP Second|Placebo-matching 4-AP administered 3 hours before normal sleep time on first study night, then a 1-week non-treatment period, then 4-AP administered 3 hours before normal sleep time on second study night.
11965|NCT02656160|P1|Participant Flow|4-AP First, Placebo Second|4-AP 10 mg administered 3 hours before normal sleep time on first study night, then a 1-week non-treatment period, then placebo-matching 4-AP administered 3 hours before normal sleep time on second study night.
11966|NCT02656160|O2|Outcome|Dalfampridine|Dalfampridine: Dalfampridine 10 mg extended release 3 hrs before sleep
11967|NCT02656160|O1|Outcome|Placebo|Placebo: Placebo 3 hrs before sleep
11968|NCT02656160|O2|Outcome|Dalfampridine|Dalfampridine: Dalfampridine 10 mg extended release 3 hrs before sleep
11969|NCT02656160|O1|Outcome|Placebo|Placebo: Placebo 3 hrs before sleep
11970|NCT02656160|E2|Reported Event|Dalfampridine|Dalfampridine: Dalfampridine 10 mg extended release 3 hrs before sleep
11971|NCT02656160|E1|Reported Event|Placebo|Placebo: Placebo 3 hrs before sleep
11973|NCT02654145|P1|Participant Flow|Mepolizumab 100 mg SC|Eligible participants received mepolizumab 100 mg SC doses into the upper arm or thigh every 4 weeks over a period of 32 weeks, with the last dose administered at Week 28, along with their current maintenance therapy except omalizumab.
11974|NCT02654145|O1|Outcome|Mepolizumab 100 mg SC|Eligible participants received mepolizumab 100 mg SC doses into the upper arm or thigh every 4 weeks over a period of 32 weeks, with the last dose administered at Week 28, along with their current maintenance therapy except omalizumab.
11975|NCT02654145|O1|Outcome|Mepolizumab 100 mg SC|Eligible participants received mepolizumab 100 mg SC doses into the upper arm or thigh every 4 weeks over a period of 32 weeks, with the last dose administered at Week 28, along with their current maintenance therapy except omalizumab.
11976|NCT02654145|O1|Outcome|Mepolizumab 100 mg SC|Eligible participants received mepolizumab 100 mg SC doses into the upper arm or thigh every 4 weeks over a period of 32 weeks, with the last dose administered at Week 28, along with their current maintenance therapy except omalizumab.
11977|NCT02654145|O1|Outcome|Mepolizumab 100 mg SC|Eligible participants received mepolizumab 100 mg SC doses into the upper arm or thigh every 4 weeks over a period of 32 weeks, with the last dose administered at Week 28, along with their current maintenance therapy except omalizumab.
11978|NCT02654145|E1|Reported Event|Mepolizumab 100 mg SC|Eligible participants received mepolizumab 100 mg SC doses into the upper arm or thigh every 4 weeks over a period of 32 weeks, with the last dose administered at Week 28, along with their current maintenance therapy except omalizumab.
11979|NCT02653872|B1|Baseline|All Participants|All 15 participants who were enrolled in the study and who received at least a single dose of the study drug in three treatment periods in a fixed sequence and were separated by a washout period.
11980|NCT02653872|P1|Participant Flow|All Participants|All 15 participants who were enrolled in the study and who received at least a single dose of the study drug in three treatment periods in a fixed sequence and were separated by a washout period.
11981|NCT02653872|O3|Outcome|OH-itraconazole (a Metabolite of Itraconazole)|Participants received Itraconazole (200 mg; oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily on Days 2 to 11 (1 hour before food) plus administration of AZD7986 (25 mg) as a single dose on Day 6 (1 hour before food).
11982|NCT02653872|O2|Outcome|Itraconazole|Participants received Itraconazole (200 mg; oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily on Days 2 to 11 (1 hour before food) plus administration of AZD7986 (25 mg) as a single dose on Day 6 (1 hour before food).
11983|NCT02653872|O1|Outcome|Verapamil|Participants received Verapamil (240 mg; extended release formulation) administered daily (1 hour before food) on Days 1 to 10 plus administration of a single dose of AZD7986 (25 mg) on Day 5 (1 hour before food).
11984|NCT02653872|O3|Outcome|OH-itraconazole (a Metabolite of Itraconazole)|Participants received Itraconazole (200 mg; oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily on Days 2 to 11 (1 hour before food) plus administration of AZD7986 (25 mg) as a single dose on Day 6 (1 hour before food).
11985|NCT02653872|O2|Outcome|Itraconazole|Participants received Itraconazole (200 mg; oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily on Days 2 to 11 (1 hour before food) plus administration of AZD7986 (25 mg) as a single dose on Day 6 (1 hour before food).
11986|NCT02653872|O1|Outcome|Verapamil|Participants received Verapamil (240 mg; extended release formulation) administered daily (1 hour before food) on Days 1 to 10 plus administration of a single dose of AZD7986 (25 mg) on Day 5 (1 hour before food).
11987|NCT02653872|O3|Outcome|AZD7986 + Itraconazole|Participants received Itraconazole (200 mg; oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily on Days 2 to 11 (1 hour before food) plus administration of AZD7986 (25 mg) as a single dose on Day 6 (1 hour before food).
11988|NCT02653872|O2|Outcome|AZD7986 + Verapamil|Participants received Verapamil (240 mg; extended release formulation) administered daily (1 hour before food) on Days 1 to 10 plus administration of a single dose of AZD7986 (25 mg) on Day 5 (1 hour before food).
11989|NCT02653872|O1|Outcome|AZD7986|Participants received a single dose of AZD7986 (25 mg) administration on Day 1 (1 hour before food).
11990|NCT02653872|O3|Outcome|AZD7986 + Itraconazole|Participants received Itraconazole (200 mg; oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily on Days 2 to 11 (1 hour before food) plus administration of AZD7986 (25 mg) as a single dose on Day 6 (1 hour before food).
11991|NCT02653872|O2|Outcome|AZD7986 + Verapamil|Participants received Verapamil (240 mg; extended release formulation) administered daily (1 hour before food) on Days 1 to 10 plus administration of a single dose of AZD7986 (25 mg) on Day 5 (1 hour before food).
11992|NCT02653872|O1|Outcome|AZD7986|Participants received a single dose of AZD7986 (25 mg) administration on Day 1 (1 hour before food).
11993|NCT02653872|O3|Outcome|AZD7986 + Itraconazole|Participants received Itraconazole (200 mg; oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily on Days 2 to 11 (1 hour before food) plus administration of AZD7986 (25 mg) as a single dose on Day 6 (1 hour before food).
11994|NCT02653872|O2|Outcome|AZD7986 + Verapamil|Participants received Verapamil (240 mg; extended release formulation) administered daily (1 hour before food) on Days 1 to 10 plus administration of a single dose of AZD7986 (25 mg) on Day 5 (1 hour before food).
11995|NCT02653872|O1|Outcome|AZD7986|Participants received a single dose of AZD7986 (25 mg) administration on Day 1 (1 hour before food).
11996|NCT02653872|O3|Outcome|AZD7986 + Itraconazole|Participants received Itraconazole (200 mg; oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily on Days 2 to 11 (1 hour before food) plus administration of AZD7986 (25 mg) as a single dose on Day 6 (1 hour before food).
11997|NCT02653872|O2|Outcome|AZD7986 + Verapamil|Participants received Verapamil (240 mg; extended release formulation) administered daily (1 hour before food) on Days 1 to 10 plus administration of a single dose of AZD7986 (25 mg) on Day 5 (1 hour before food).
11998|NCT02653872|O1|Outcome|AZD7986|Participants received a single dose of AZD7986 (25 mg) administration on Day 1 (1 hour before food).
11999|NCT02653872|O3|Outcome|AZD7986 + Itraconazole|Participants received Itraconazole (200 mg; oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily on Days 2 to 11 (1 hour before food) plus administration of AZD7986 (25 mg) as a single dose on Day 6 (1 hour before food).
12001|NCT02653872|O1|Outcome|AZD7986|Participants received a single dose of AZD7986 (25 mg) administration on Day 1 (1 hour before food).
12002|NCT02653872|O3|Outcome|AZD7986 + Itraconazole|Participants received Itraconazole (200 mg; oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily on Days 2 to 11 (1 hour before food) plus administration of AZD7986 (25 mg) as a single dose on Day 6 (1 hour before food).
12003|NCT02653872|O2|Outcome|AZD7986 + Verapamil|Participants received Verapamil (240 mg; extended release formulation) administered daily (1 hour before food) on Days 1 to 10 plus administration of a single dose of AZD7986 (25 mg) on Day 5 (1 hour before food).
12004|NCT02653872|O1|Outcome|AZD7986|Participants received a single dose of AZD7986 (25 mg) administration on Day 1 (1 hour before food).
12005|NCT02653872|O3|Outcome|AZD7986 + Itraconazole|Participants received Itraconazole (200 mg; oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily on Days 2 to 11 (1 hour before food) plus administration of AZD7986 (25 mg) as a single dose on Day 6 (1 hour before food).
12006|NCT02653872|O2|Outcome|AZD7986 + Verapamil|Participants received Verapamil (240 mg; extended release formulation) administered daily (1 hour before food) on Days 1 to 10 plus administration of a single dose of AZD7986 (25 mg) on Day 5 (1 hour before food).
12007|NCT02653872|O1|Outcome|AZD7986|Participants received a single dose of AZD7986 (25 mg) administration on Day 1 (1 hour before food).
12008|NCT02653872|E6|Reported Event|All Subjects|Overall number of participants in the study.
12009|NCT02653872|E5|Reported Event|Itraconazole|Participants received Itraconazole.
12010|NCT02653872|E4|Reported Event|Verapamil|Participants received Verapamil
12011|NCT02653872|E3|Reported Event|AZD7986 + Itraconazole|Participants received Itraconazole (200 mg; oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily on Days 2 to 11 (1 hour before food) plus administration of AZD7986 (25 mg) as a single dose on Day 6 (1 hour before food).
12012|NCT02653872|E2|Reported Event|AZD7986 + Verapamil|Participants received Verapamil (240 mg; extended release formulation) administered daily (1 hour before food) on Days 1 to 10 plus administration of a single dose of AZD7986 (25 mg) on Day 5 (1 hour before food).
12013|NCT02653872|E1|Reported Event|AZD7986|Participants received a single dose of AZD7986 (25 mg) administration on Day 1 (1 hour before food).
12014|NCT02653560|B1|Baseline|All Study Participants|Participants took Potassium magnesium Citrate (KMgCit), potassium citrate (KCit), potassium chloride (KCl) and placebo each for 4 weeks in a randomized crossover design.
12015|NCT02653560|P4|Participant Flow|Placebo|"Placebo will comprise microcrystalline cellulose, equivalent in volume in each sachet as other test products. During the Placebo Phase, subjects will dissolve the entire content of a sachet in 250 ml water and drink it with breakfast and again with dinner for 4 weeks.~Placebo"
12016|NCT02653560|P3|Participant Flow|Potassium Chloride Arm|"Potassium chloride will contain 20 meq KCl per sachet. During the Potassium Chloride Phase, subjects will dissolve the content of each sachet in 250 ml water and ingest it with breakfast and again with dinner, to deliver 40 meq K (as chloride) per day for 4 weeks~Potassium chloride powder"
12017|NCT02653560|P2|Participant Flow|Potassium Citrate Arm|"A special sachet formulation containing 20 meq K/sachet will be made for the study by Meta Pharm Development. The contents of a sachet will be added to 250 ml water and drunk with breakfast and dinner, to deliver 40 meq K (as citrate) per day during the Potassium Citrate Phase for 4 weeks.~Potassium citrate powder"
12018|NCT02653560|P1|Participant Flow|Potassium Magnesium Citrate (KMgCit) Arm|"Potassium magnesium citrate will be prepared by mixing potassium citrate, magnesium citrate and/or citric acid by Meta Pharm Development. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day for 4 weeks~Potassium magnesium Citrate (KMgCit)"
12019|NCT02653560|O4|Outcome|Placebo|"Placebo will comprise microcrystalline cellulose, equivalent in volume in each sachet as other test products. During the Placebo Phase, subjects will dissolve the entire content of a sachet in 250 ml water and drink it with breakfast and again with dinner for 4 weeks.~Placebo"
12020|NCT02653560|O3|Outcome|Potassium Chloride Arm|"Potassium chloride will contain 20 meq KCl per sachet. During the Potassium Chloride Phase, subjects will dissolve the content of each sachet in 250 ml water and ingest it with breakfast and again with dinner, to deliver 40 meq K (as chloride) per day for 4 weeks~Potassium chloride powder"
12021|NCT02653560|O2|Outcome|Potassium Citrate Arm|"A special sachet formulation containing 20 meq K/sachet will be made for the study by Meta Pharm Development. The contents of a sachet will be added to 250 ml water and drunk with breakfast and dinner, to deliver 40 meq K (as citrate) per day during the Potassium Citrate Phase for 4 weeks.~Potassium citrate powder"
12022|NCT02653560|O1|Outcome|Potassium Magnesium Citrate (KMgCit) Arm|"Potassium magnesium citrate will be prepared by mixing potassium citrate, magnesium citrate and/or citric acid by Meta Pharm Development. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day for 4 weeks~Potassium magnesium Citrate (KMgCit)"
12023|NCT02653560|E4|Reported Event|Placebo|"Placebo will comprise microcrystalline cellulose, equivalent in volume in each sachet as other test products. During the Placebo Phase, subjects will dissolve the entire content of a sachet in 250 ml water and drink it with breakfast and again with dinner for 4 weeks.~Placebo"
12024|NCT02653560|E3|Reported Event|Potassium Chloride Arm|"Potassium chloride will contain 20 meq KCl per sachet. During the Potassium Chloride Phase, subjects will dissolve the content of each sachet in 250 ml water and ingest it with breakfast and again with dinner, to deliver 40 meq K (as chloride) per day for 4 weeks~Potassium chloride powder"
12025|NCT02653560|E2|Reported Event|Potassium Citrate Arm|"A special sachet formulation containing 20 meq K/sachet will be made for the study by Meta Pharm Development. The contents of a sachet will be added to 250 ml water and drunk with breakfast and dinner, to deliver 40 meq K (as citrate) per day during the Potassium Citrate Phase for 4 weeks.~Potassium citrate powder"
12026|NCT02653560|E1|Reported Event|Potassium Magnesium Citrate (KMgCit) Arm|"Potassium magnesium citrate will be prepared by mixing potassium citrate, magnesium citrate and/or citric acid by Meta Pharm Development. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day for 4 weeks~Potassium magnesium Citrate (KMgCit)"
12027|NCT02653495|B3|Baseline|Total|Total of all reporting groups
20059|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
12029|NCT02653495|B1|Baseline|Influenza Vaccine in Metabolic Syndrome|"Influenza vaccine~Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3"
12030|NCT02653495|P2|Participant Flow|Influenza Vaccine in Healthy Controls|"Influenza vaccine~Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3"
12031|NCT02653495|P1|Participant Flow|Influenza Vaccine in Metabolic Syndrome|"Influenza vaccine~Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3"
12032|NCT02653495|O2|Outcome|Influenza Vaccine in Healthy Controls|"Influenza vaccine~Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3"
12033|NCT02653495|O1|Outcome|Influenza Vaccine in Metabolic Syndrome|"Influenza vaccine~Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3"
12034|NCT02653495|O2|Outcome|Influenza Vaccine in Healthy Controls|"Influenza vaccine~Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3"
12035|NCT02653495|O1|Outcome|Influenza Vaccine in Metabolic Syndrome|"Influenza vaccine~Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3"
12036|NCT02653495|O2|Outcome|Influenza Vaccine in Healthy Controls|"Influenza vaccine~Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3"
12037|NCT02653495|O1|Outcome|Influenza Vaccine in Metabolic Syndrome|"Influenza vaccine~Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3"
12038|NCT02653495|O2|Outcome|Influenza Vaccine in Healthy Controls|"Influenza vaccine~Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3"
12039|NCT02653495|O1|Outcome|Influenza Vaccine in Metabolic Syndrome|"Influenza vaccine~Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3"
12040|NCT02653495|O2|Outcome|Influenza Vaccine in Healthy Controls|"Influenza vaccine~Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3"
12041|NCT02653495|O1|Outcome|Influenza Vaccine in Metabolic Syndrome|"Influenza vaccine~Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3"
12042|NCT02653495|E2|Reported Event|Influenza Vaccine in Healthy Controls|"Influenza vaccine~Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3"
12043|NCT02653495|E1|Reported Event|Influenza Vaccine in Metabolic Syndrome|"Influenza vaccine~Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3"
12044|NCT02652221|B1|Baseline|Study Cohort|"Acoustic Radiation Force Imaging~Acoustic Radiation Force Imaging: ARFI US is a novel technique, recently FDA approved for use in children and adults, which provides an alternative method for quantifying liver stiffness."
12045|NCT02652221|P1|Participant Flow|Study Cohort|"Acoustic Radiation Force Imaging~Acoustic Radiation Force Imaging: ARFI US is a novel technique, recently FDA approved for use in children and adults, which provides an alternative method for quantifying liver stiffness."
12046|NCT02652221|O2|Outcome|BMI >30kg/m2|Subset of study cohort with BMI 30 kg/m2 or more
12047|NCT02652221|O1|Outcome|BMI <30 kg/m2|Subset of study cohort with BMI <30 kg/m2
12048|NCT02652221|O2|Outcome|BMI >30kg/m2|Subset of study cohort with BMI 30 kg/m2 or more
12049|NCT02652221|O1|Outcome|BMI <30 kg/m2|Subset of study cohort with BMI <30 kg/m2
12050|NCT02652221|E1|Reported Event|Study Cohort|"Acoustic Radiation Force Imaging~Acoustic Radiation Force Imaging: ARFI US is a novel technique, recently FDA approved for use in children and adults, which provides an alternative method for quantifying liver stiffness."
12051|NCT02652208|B3|Baseline|Total|Total of all reporting groups
12052|NCT02652208|B2|Baseline|Video Decision Aid|"This group will receive the DVD and booklet decision aid describing stable chest discomfort and the main treatment options including medical therapy and stents.~Video decision aid: The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort"
12053|NCT02652208|B1|Baseline|Online Decision Aid|"This group will receive the access to an online decision aid that covers the main treatment options for stable chest discomfort.~Online decision aid: The Healthwise online shared decision point for Stable Chest Discomfort"
12054|NCT02652208|P2|Participant Flow|Video Decision Aid|"This group will receive the DVD and booklet decision aid describing stable chest discomfort and the main treatment options including medical therapy and stents.~Video decision aid: The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort"
12055|NCT02652208|P1|Participant Flow|Online Decision Aid|"This group will receive the access to an online decision aid that covers the main treatment options for stable chest discomfort.~Online decision aid: The Healthwise online shared decision point for Stable Chest Discomfort"
12056|NCT02652208|O2|Outcome|Video Decision Aid|"This group will receive the DVD and booklet decision aid describing stable chest discomfort and the main treatment options including medical therapy and stents.~Video decision aid: The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort"
12057|NCT02652208|O1|Outcome|Online Decision Aid|"This group will receive the access to an online decision aid that covers the main treatment options for stable chest discomfort.~Online decision aid: The Healthwise online shared decision point for Stable Chest Discomfort"
12058|NCT02652208|O2|Outcome|Video Decision Aid|"This group will receive the DVD and booklet decision aid describing stable chest discomfort and the main treatment options including medical therapy and stents.~Video decision aid: The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort"
12059|NCT02652208|O1|Outcome|Online Decision Aid|"This group will receive the access to an online decision aid that covers the main treatment options for stable chest discomfort.~Online decision aid: The Healthwise online shared decision point for Stable Chest Discomfort"
12060|NCT02652208|O2|Outcome|Video Decision Aid|"This group will receive the DVD and booklet decision aid describing stable chest discomfort and the main treatment options including medical therapy and stents.~Video decision aid: The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort"
12061|NCT02652208|O1|Outcome|Online Decision Aid|"This group will receive the access to an online decision aid that covers the main treatment options for stable chest discomfort.~Online decision aid: The Healthwise online shared decision point for Stable Chest Discomfort"
12214|NCT02648438|O1|Outcome|400 µg DPI Device 1|AZD7594 400 μg delivered dose via Monodose inhaler
12062|NCT02652208|E2|Reported Event|Video Decision Aid|"This group will receive the DVD and booklet decision aid describing stable chest discomfort and the main treatment options including medical therapy and stents.~Video decision aid: The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort"
12063|NCT02652208|E1|Reported Event|Online Decision Aid|"This group will receive the access to an online decision aid that covers the main treatment options for stable chest discomfort.~Online decision aid: The Healthwise online shared decision point for Stable Chest Discomfort"
12064|NCT02651922|B1|Baseline|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
12065|NCT02651922|P1|Participant Flow|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
12066|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
12067|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
12068|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
12069|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
12070|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
12071|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
12072|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
12073|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
12074|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
12075|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
12076|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
12077|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
12078|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
12079|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
12080|NCT02651922|E1|Reported Event|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
12081|NCT02651467|B4|Baseline|Total|Total of all reporting groups
12082|NCT02651467|B3|Baseline|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
12083|NCT02651467|B2|Baseline|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
12084|NCT02651467|B1|Baseline|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% w/w KOX, 0ppm F, pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
12085|NCT02651467|P3|Participant Flow|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
12086|NCT02651467|P2|Participant Flow|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
12087|NCT02651467|P1|Participant Flow|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20millilitre (mL) of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% weight by weight [w/w] KOX, 0 parts per million [ppm], pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
12088|NCT02651467|O3|Outcome|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
12089|NCT02651467|O2|Outcome|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
20060|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
12090|NCT02651467|O1|Outcome|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% w/w KOX, 0ppm F, pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
12091|NCT02651467|O3|Outcome|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )(using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
12092|NCT02651467|O2|Outcome|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
12093|NCT02651467|O1|Outcome|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% w/w KOX, 0ppm F, pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
12094|NCT02651467|O3|Outcome|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
12095|NCT02651467|O2|Outcome|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
12096|NCT02651467|O1|Outcome|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% w/w KOX, 0ppm F, pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
12097|NCT02651467|O2|Outcome|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
12098|NCT02651467|O1|Outcome|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% w/w KOX, 0ppm F, pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
12099|NCT02651467|O3|Outcome|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
12100|NCT02651467|O2|Outcome|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
12101|NCT02651467|O1|Outcome|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% w/w KOX, 0ppm F, pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
12215|NCT02648438|O4|Outcome|400 µg pMDI (Additional)|AZD7594 400 μg delivered dose pMDI (Separate treatment)
12216|NCT02648438|O3|Outcome|400 µg pMDI|AZD7594 400 μg delivered dose pMDI
12217|NCT02648438|O2|Outcome|400 µg DPI Device 2|AZD7594 400 μg delivered dose via Multiple dose inhaler
20061|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
12102|NCT02651467|E3|Reported Event|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo oral rinse (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
12103|NCT02651467|E2|Reported Event|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
12104|NCT02651467|E1|Reported Event|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20millilitre (mL) of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
12105|NCT02651194|B1|Baseline|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
12106|NCT02651194|P1|Participant Flow|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
12107|NCT02651194|O1|Outcome|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
12108|NCT02651194|O1|Outcome|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
12109|NCT02651194|O1|Outcome|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
12110|NCT02651194|E1|Reported Event|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
12111|NCT02650440|B3|Baseline|Total|Total of all reporting groups
12112|NCT02650440|B2|Baseline|Standard Protocol|"Progressive increase of speed and decrease of guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.9 km/h.~Standard Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject"
12113|NCT02650440|B1|Baseline|Novel Protocol|"Progressive decrease of speed and guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.0 km/h.~Novel Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject."
12114|NCT02650440|P2|Participant Flow|Standard Protocol|"Progressive increase of speed and decrease of guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.9 km/h.~Standard Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject"
12115|NCT02650440|P1|Participant Flow|Novel Protocol|"Progressive decrease of speed and guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.0 km/h.~Novel Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject."
12116|NCT02650440|O2|Outcome|Standard Protocol|"Progressive increase of speed and decrease of guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.9 km/h.~Standard Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject"
12117|NCT02650440|O1|Outcome|Novel Protocol|"Progressive decrease of speed and guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.0 km/h.~Novel Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject."
12218|NCT02648438|O1|Outcome|400 µg DPI Device 1|AZD7594 400 μg delivered dose via Monodose inhaler
12219|NCT02648438|O4|Outcome|400 µg pMDI (Additional)|AZD7594 400 μg delivered dose pMDI (Separate treatment)
12220|NCT02648438|O3|Outcome|400 µg pMDI|AZD7594 400 μg delivered dose pMDI
12221|NCT02648438|O2|Outcome|400 µg DPI Device 2|AZD7594 400 μg delivered dose via Multiple dose inhaler
20062|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
12118|NCT02650440|O2|Outcome|Standard Protocol|"Progressive increase of speed and decrease of guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.9 km/h.~Standard Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject"
12119|NCT02650440|O1|Outcome|Novel Protocol|"Progressive decrease of speed and guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.0 km/h.~Novel Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject."
12120|NCT02650440|O2|Outcome|Standard Protocol|"Progressive increase of speed and decrease of guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.9 km/h.~Standard Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject"
12121|NCT02650440|O1|Outcome|Novel Protocol|"Progressive decrease of speed and guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.0 km/h.~Novel Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject."
12122|NCT02650440|O2|Outcome|Standard Protocol|"Progressive increase of speed and decrease of guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.9 km/h.~Standard Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject"
12123|NCT02650440|O1|Outcome|Novel Protocol|"Progressive decrease of speed and guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.0 km/h.~Novel Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject."
12124|NCT02650440|O2|Outcome|Standard Protocol|"Progressive increase of speed and decrease of guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.9 km/h.~Standard Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject"
12125|NCT02650440|O1|Outcome|Novel Protocol|"Progressive decrease of speed and guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.0 km/h.~Novel Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject."
12126|NCT02650440|O2|Outcome|Standard Protocol|"Progressive increase of speed and decrease of guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.9 km/h.~Standard Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject"
12127|NCT02650440|O1|Outcome|Novel Protocol|"Progressive decrease of speed and guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.0 km/h.~Novel Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject."
12222|NCT02648438|O1|Outcome|400 µg DPI Device 1|AZD7594 400 μg delivered dose via Monodose inhaler
12223|NCT02648438|O6|Outcome|1200 µg Oral Formulation|AZD7594 1200 μg oral formulation
12224|NCT02648438|O5|Outcome|150 µg IV Formulation|AZD7594 150 µg IV formulation
12128|NCT02650440|E2|Reported Event|Standard Protocol|"Progressive increase of speed and decrease of guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.9 km/h.~Standard Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject"
12129|NCT02650440|E1|Reported Event|Novel Protocol|"Progressive decrease of speed and guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.0 km/h.~Novel Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject."
12130|NCT02650219|B3|Baseline|Total|Total of all reporting groups
12131|NCT02650219|B2|Baseline|Control|"healthy subjects intervention: genetic analyses~genetic analyses"
12132|NCT02650219|B1|Baseline|Gaucher Disease Type 1|"Inclusion criteria:~Adult patients >= 18 years old~Gaucher disease type 1, proved by low betaglucosidase, with or without treatment~Patients must have read, understood and signed informed consent. intervention : genetic analyses~genetic analyses"
12133|NCT02650219|P2|Participant Flow|Control|"healthy subjects intervention: genetic analyses~genetic analyses"
12134|NCT02650219|P1|Participant Flow|Gaucher Disease Type 1|"Inclusion criteria:~Adult patients >= 18 years old~Gaucher disease type 1, proved by low betaglucosidase, with or without treatment~Patients must have read, understood and signed informed consent. intervention : genetic analyses~genetic analyses"
12135|NCT02650219|O2|Outcome|Control|"healthy subjects intervention: genetic analyses~genetic analyses"
12136|NCT02650219|O1|Outcome|Gaucher Disease Type 1|"Inclusion criteria:~Adult patients >= 18 years old~Gaucher disease type 1, proved by low betaglucosidase, with or without treatment~Patients must have read, understood and signed informed consent. intervention : genetic analyses~genetic analyses"
12137|NCT02650219|O2|Outcome|Control|"healthy subjects intervention: genetic analyses~genetic analyses"
12138|NCT02650219|O1|Outcome|Gaucher Disease Type 1|"Inclusion criteria:~Adult patients >= 18 years old~Gaucher disease type 1, proved by low betaglucosidase, with or without treatment~Patients must have read, understood and signed informed consent. intervention : genetic analyses~genetic analyses"
12139|NCT02650219|O2|Outcome|Control|"healthy subjects intervention: genetic analyses~genetic analyses"
12140|NCT02650219|O1|Outcome|Gaucher Disease Type 1|"Inclusion criteria:~Adult patients >= 18 years old~Gaucher disease type 1, proved by low betaglucosidase, with or without treatment~Patients must have read, understood and signed informed consent. intervention : genetic analyses~genetic analyses"
12141|NCT02650219|E2|Reported Event|Control|"healthy subjects intervention: genetic analyses~genetic analyses"
12142|NCT02650219|E1|Reported Event|Gaucher Disease Type 1|"Inclusion criteria:~Adult patients >= 18 years old~Gaucher disease type 1, proved by low betaglucosidase, with or without treatment~Patients must have read, understood and signed informed consent. intervention : genetic analyses~genetic analyses"
12143|NCT02649634|B3|Baseline|Total|Total of all reporting groups
12144|NCT02649634|B2|Baseline|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12145|NCT02649634|B1|Baseline|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12146|NCT02649634|P2|Participant Flow|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12225|NCT02648438|O4|Outcome|400 µg pMDI (Additional)|AZD7594 400 μg delivered dose pMDI (Separate treatment)
12226|NCT02648438|O3|Outcome|400 µg pMDI|AZD7594 400 μg delivered dose pMDI
12227|NCT02648438|O2|Outcome|400 µg DPI Device 2|AZD7594 400 μg delivered dose via Multiple dose inhaler
12228|NCT02648438|O1|Outcome|400 µg DPI Device 1|AZD7594 400 μg delivered dose via Monodose inhaler
12229|NCT02648438|O6|Outcome|1200 µg Oral Formulation|AZD7594 1200 μg oral formulation
12147|NCT02649634|P1|Participant Flow|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12148|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12149|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12150|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12151|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12152|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12153|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12154|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12230|NCT02648438|O5|Outcome|150 µg IV Formulation|AZD7594 150 µg IV formulation
12231|NCT02648438|O4|Outcome|400 µg pMDI (Additional)|AZD7594 400 μg delivered dose pMDI (Separate treatment)
12232|NCT02648438|O3|Outcome|400 µg pMDI|AZD7594 400 μg delivered dose pMDI
12233|NCT02648438|O2|Outcome|400 µg DPI Device 2|AZD7594 400 μg delivered dose via Multiple dose inhaler
12234|NCT02648438|O1|Outcome|400 µg DPI Device 1|AZD7594 400 μg delivered dose via Monodose inhaler
12155|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12156|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12157|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12158|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12159|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12160|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12161|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12162|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12235|NCT02648438|O2|Outcome|1200 µg Oral Formulation|AZD7594 1200 μg oral formulation
12236|NCT02648438|O1|Outcome|150 µg IV Formulation|AZD7594 150 µg IV formulation
12237|NCT02648438|O4|Outcome|400 µg pMDI (Additional)|AZD7594 400 μg delivered dose pMDI (Separate treatment)
12238|NCT02648438|O3|Outcome|400 µg pMDI|AZD7594 400 μg delivered dose pMDI
12239|NCT02648438|O2|Outcome|400 µg DPI Device 2|AZD7594 400 μg delivered dose via Multiple dose inhaler
12163|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12164|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12165|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12166|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12167|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12168|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12169|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12170|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12240|NCT02648438|O1|Outcome|400 µg DPI Device 1|AZD7594 400 μg delivered dose via Monodose inhaler
12241|NCT02648438|E6|Reported Event|pMDI (Additional)|AZD7594 400 μg delivered dose pMDI (separate treatment)
12242|NCT02648438|E5|Reported Event|Oral Formulation|AZD7594 1200 μg oral formulation
12243|NCT02648438|E4|Reported Event|pMDI|AZD7594 400 μg delivered dose pMDI
12244|NCT02648438|E3|Reported Event|DPI Device 2|AZD7594 400 μg delivered dose multiple-dose DPI
12171|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12172|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12173|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12174|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12175|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12176|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12177|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12178|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12245|NCT02648438|E2|Reported Event|DPI Device 1|AZD7594 400 μg delivered dose monodose inhaler
12246|NCT02648438|E1|Reported Event|IV Formulation|AZD7594 150 μg IV formulation
12247|NCT02648204|B5|Baseline|Total|Total of all reporting groups
12248|NCT02648204|B4|Baseline|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
20063|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
12179|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12180|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12181|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12182|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12183|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12184|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12185|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12186|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12249|NCT02648204|B3|Baseline|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12250|NCT02648204|B2|Baseline|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12187|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12188|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12189|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12190|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12191|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12192|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12193|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12194|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12251|NCT02648204|B1|Baseline|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12252|NCT02648204|P4|Participant Flow|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
17728|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
12195|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12196|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12197|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12198|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12199|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12200|NCT02649634|E2|Reported Event|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
12201|NCT02649634|E1|Reported Event|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
12202|NCT02648438|B4|Baseline|Total|Total of all reporting groups
12203|NCT02648438|B3|Baseline|pMDI (Additional)|Pressurized metered-dose inhaler (pMDI)
12204|NCT02648438|B2|Baseline|IV, DPI 1, pMDI, Oral|IV formulation, monodose inhaler, pMDI, oral formulation
12205|NCT02648438|B1|Baseline|IV, DPI 1, DPI 2, Oral|IV formulation, monodose inhaler, multiple-dose DPI, oral formulation
12206|NCT02648438|P3|Participant Flow|pMDI (Additional)|Pressurized metered-dose inhaler (pMDI)
12207|NCT02648438|P2|Participant Flow|IV, DPI 1, pMDI, Oral|IV formulation, monodose inhaler, pMDI, oral formulation
12208|NCT02648438|P1|Participant Flow|IV, DPI 1, DPI 2, Oral|IV formulation, monodose inhaler, multiple-dose DPI, oral formulation
12209|NCT02648438|O6|Outcome|1200 µg Oral Formulation|AZD7594 1200 μg oral formulation
12210|NCT02648438|O5|Outcome|150 µg IV Formulation|AZD7594 150 µg IV formulation
12211|NCT02648438|O4|Outcome|400 µg pMDI (Additional)|AZD7594 400 μg delivered dose pMDI (Separate treatment)
12212|NCT02648438|O3|Outcome|400 µg pMDI|AZD7594 400 μg delivered dose pMDI
12213|NCT02648438|O2|Outcome|400 µg DPI Device 2|AZD7594 400 μg delivered dose via Multiple dose inhaler
20064|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
12253|NCT02648204|P3|Participant Flow|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12254|NCT02648204|P2|Participant Flow|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (week 1 to 4) followed by 0.5 mg for another 4 weeks (week 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (week 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12255|NCT02648204|P1|Participant Flow|Semaglutide 0.5 mg|Subjects received subcutaneous (s.c., under the skin) injections of semaglutide once weekly (OW) for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12256|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12257|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12258|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12259|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12260|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12261|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12262|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12263|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12264|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12265|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12266|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12267|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12268|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12269|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12270|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12271|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12272|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12273|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12274|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12275|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12276|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12277|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12278|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
20065|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
12279|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12280|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12281|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12282|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12283|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12284|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12285|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12286|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12287|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12288|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12289|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12290|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12291|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12292|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12293|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12294|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12295|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12296|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12297|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12298|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12299|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12300|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12301|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12302|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12303|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12304|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12305|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12306|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12307|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12308|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12309|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12310|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12311|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12312|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12313|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12314|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12315|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12316|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12317|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12318|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12319|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12320|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12321|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12322|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12323|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12324|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12325|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12326|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12327|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12328|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12329|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12330|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12331|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
17729|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
12332|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12333|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12334|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12335|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12336|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12337|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12338|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12339|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12340|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12341|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12342|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12343|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12344|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12345|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12346|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12347|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12348|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12349|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12350|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12351|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12352|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12353|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12354|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12355|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12356|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12357|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12419|NCT02647320|P4|Participant Flow|Sitagliptin 100 mg|Three placebo tablets and one sitagliptin 100 mg over-capsule in a once-daily oral dose
12420|NCT02647320|P3|Participant Flow|DS-8500a 75 mg|Three DS-8500a 25 mg tablets and one placebo capsule in a once-daily oral dose
12358|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12359|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12360|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12361|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12362|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12363|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12364|NCT02648204|O4|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12365|NCT02648204|O3|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12366|NCT02648204|O2|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12367|NCT02648204|O1|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12368|NCT02648204|E4|Reported Event|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12369|NCT02648204|E3|Reported Event|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
12370|NCT02648204|E2|Reported Event|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
12371|NCT02648204|E1|Reported Event|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
12372|NCT02648022|B3|Baseline|Total|Total of all reporting groups
12373|NCT02648022|B2|Baseline|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
12374|NCT02648022|B1|Baseline|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.~Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
12375|NCT02648022|P2|Participant Flow|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
12376|NCT02648022|P1|Participant Flow|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.~Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
12377|NCT02648022|O2|Outcome|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
12394|NCT02647944|O2|Outcome|Placebo|Placebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
12421|NCT02647320|P2|Participant Flow|DS-8500a 50 mg|Two DS-8500a 25 mg tablets, 1 placebo tablet, and one placebo capsule in a once-daily oral dose
17730|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
12378|NCT02648022|O1|Outcome|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.~Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
12379|NCT02648022|O2|Outcome|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
12380|NCT02648022|O1|Outcome|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.~Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
12381|NCT02648022|O2|Outcome|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
12382|NCT02648022|O1|Outcome|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.~Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
12383|NCT02648022|E2|Reported Event|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
12384|NCT02648022|E1|Reported Event|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.~Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
12385|NCT02647944|B3|Baseline|Total|Total of all reporting groups
12386|NCT02647944|B2|Baseline|Placebo|Placebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
12387|NCT02647944|B1|Baseline|Liraglutide|Saxenda initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
12388|NCT02647944|P2|Participant Flow|Placebo|Placebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
12389|NCT02647944|P1|Participant Flow|Liraglutide|Saxenda initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
12390|NCT02647944|O2|Outcome|Placebo|Placebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
12391|NCT02647944|O1|Outcome|Liraglutide|Saxenda initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
12392|NCT02647944|O2|Outcome|Placebo|Placebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
12393|NCT02647944|O1|Outcome|Liraglutide|Saxenda initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
12395|NCT02647944|O1|Outcome|Liraglutide|Saxenda initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
12396|NCT02647944|O2|Outcome|Placebo|Placebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
12397|NCT02647944|O1|Outcome|Liraglutide|Saxenda initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
12398|NCT02647944|O2|Outcome|Placebo|Placebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
12399|NCT02647944|O1|Outcome|Liraglutide|Saxenda initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
12400|NCT02647944|O2|Outcome|Placebo|Placebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
12401|NCT02647944|O1|Outcome|Liraglutide|Saxenda initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
12402|NCT02647944|O2|Outcome|Placebo|Placebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
12403|NCT02647944|O1|Outcome|Liraglutide|Saxenda initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
12404|NCT02647944|O2|Outcome|Placebo|Placebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
12405|NCT02647944|O1|Outcome|Liraglutide|Saxenda initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
12406|NCT02647944|O2|Outcome|Placebo|Placebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
12407|NCT02647944|O1|Outcome|Liraglutide|Saxenda initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
12408|NCT02647944|O2|Outcome|Placebo|Placebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
12409|NCT02647944|O1|Outcome|Liraglutide|Saxenda initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
12410|NCT02647944|E2|Reported Event|Placebo|Placebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
12411|NCT02647944|E1|Reported Event|Liraglutide|Saxenda initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
12412|NCT02647320|B6|Baseline|Total|Total of all reporting groups
12413|NCT02647320|B5|Baseline|Placebo|Three placebo tablets and one placebo capsule in a once-daily oral dose
12414|NCT02647320|B4|Baseline|Sitagliptin 100 mg|Three placebo tablets and one sitagliptin 100 mg over-capsule in a once-daily oral dose
12415|NCT02647320|B3|Baseline|DS-8500a 75 mg|Three DS-8500a 25 mg tablets and one placebo capsule in a once-daily oral dose
12416|NCT02647320|B2|Baseline|DS-8500a 50 mg|Two DS-8500a 25 mg tablets, 1 placebo tablet, and one placebo capsule in a once-daily oral dose
12417|NCT02647320|B1|Baseline|DS-8500a 25mg|One DS-8500a 25 mg tablet, 2 placebo tablets, and one placebo capsule in a once-daily oral dose
12418|NCT02647320|P5|Participant Flow|Placebo|Three placebo tablets and one placebo capsule in a once-daily oral dose
12422|NCT02647320|P1|Participant Flow|DS-8500a 25mg|One DS-8500a 25 mg tablet, 2 placebo tablets, and one placebo capsule in a once-daily oral dose
12423|NCT02647320|O5|Outcome|Placebo|Placebo tablets and placebo capsule
12424|NCT02647320|O4|Outcome|Sitagliptin 100 mg|One sitagliptin 100 mg over-capsule and placebo
12425|NCT02647320|O3|Outcome|DS-8500a 75 mg|Three DS-8500a 25 mg tablets and placebo
12426|NCT02647320|O2|Outcome|DS-8500a 50 mg|Two DS-8500a 25 mg tablets and placebo
12427|NCT02647320|O1|Outcome|DS-8500a 25mg|One DS-8500a 25 mg tablet and placebo
12428|NCT02647320|O5|Outcome|Placebo|Placebo tablets and capsule
12429|NCT02647320|O4|Outcome|Sitagliptin 100 mg|One sitagliptin 100 mg over-capsule and placebo
12430|NCT02647320|O3|Outcome|DS-8500a 75 mg|Three DS-8500a 25 mg tablets and placebo
12431|NCT02647320|O2|Outcome|DS-8500a 50 mg|Two DS-8500a 25 mg tablets and placebo
12432|NCT02647320|O1|Outcome|DS-8500a 25mg|One DS-8500a 25 mg tablet and placebo
12433|NCT02647320|O5|Outcome|Placebo|Placebo tablets and capsule
12434|NCT02647320|O4|Outcome|Sitagliptin 100 mg|One sitagliptin 100 mg over-capsule and placebo
12435|NCT02647320|O3|Outcome|DS-8500a 75 mg|Three DS-8500a 25 mg tablets and placebo
12436|NCT02647320|O2|Outcome|DS-8500a 50 mg|Two DS-8500a 25 mg tablets and placebo
12437|NCT02647320|O1|Outcome|DS-8500a 25mg|One DS-8500a 25 mg tablet and placebo
12438|NCT02647320|O5|Outcome|Placebo|Placebo tablets and capsule
12439|NCT02647320|O4|Outcome|Sitagliptin 100 mg|One sitagliptin 100 mg over-capsule and placebo
12440|NCT02647320|O3|Outcome|DS-8500a 75 mg|Three DS-8500a 25 mg tablets and placebo
12441|NCT02647320|O2|Outcome|DS-8500a 50 mg|Two DS-8500a 25 mg tablets and placebo
12442|NCT02647320|O1|Outcome|DS-8500a 25mg|One DS-8500a 25 mg tablet and placebo
12443|NCT02647320|O5|Outcome|Placebo|Placebo tablets and capsule
12444|NCT02647320|O4|Outcome|Sitagliptin 100 mg|One sitagliptin 100 mg over-capsule and placebo
12445|NCT02647320|O3|Outcome|DS-8500a 75 mg|Three DS-8500a 25 mg tablets and placebo
12446|NCT02647320|O2|Outcome|DS-8500a 50 mg|Two DS-8500a 25 mg tablets and placebo
12447|NCT02647320|O1|Outcome|DS-8500a 25mg|One DS-8500a 25 mg tablet and placebo
12448|NCT02647320|O5|Outcome|Placebo|Placebo tablets and capsule
12449|NCT02647320|O4|Outcome|Sitagliptin 100 mg|One sitagliptin 100 mg over-capsule and placebo
12450|NCT02647320|O3|Outcome|DS-8500a 75 mg|Three DS-8500a 25 mg tablets and placebo
12451|NCT02647320|O2|Outcome|DS-8500a 50 mg|Two DS-8500a 25 mg tablets and placebo
12452|NCT02647320|O1|Outcome|DS-8500a 25mg|One DS-8500a 25 mg tablet and placebo
12453|NCT02647320|O5|Outcome|Placebo|Placebo tablets and capsule
12454|NCT02647320|O4|Outcome|Sitagliptin 100 mg|One sitagliptin 100 mg over-capsule and placebo
12455|NCT02647320|O3|Outcome|DS-8500a 75 mg|Three DS-8500a 25 mg tablets and placebo
12456|NCT02647320|O2|Outcome|DS-8500a 50 mg|Two DS-8500a 25 mg tablets and placebo
12457|NCT02647320|O1|Outcome|DS-8500a 25mg|One DS-8500a 25 mg tablet and placebo
12458|NCT02647320|O5|Outcome|Placebo|Placebo tablets and capsule
12459|NCT02647320|O4|Outcome|Sitagliptin 100 mg|One sitagliptin 100 mg over-capsule and placebo
12460|NCT02647320|O3|Outcome|DS-8500a 75 mg|Three DS-8500a 25 mg tablets and placebo
12461|NCT02647320|O2|Outcome|DS-8500a 50 mg|Two DS-8500a 25 mg tablets and placebo
12462|NCT02647320|O1|Outcome|DS-8500a 25mg|One DS-8500a 25 mg tablet and placebo
12463|NCT02647320|O5|Outcome|Placebo|Placebo tablets and capsule
12464|NCT02647320|O4|Outcome|Sitagliptin 100 mg|One sitagliptin 100 mg over-capsule and placebo
12465|NCT02647320|O3|Outcome|DS-8500a 75 mg|Three DS-8500a 25 mg tablets and placebo
12466|NCT02647320|O2|Outcome|DS-8500a 50 mg|Two DS-8500a 25 mg tablets and placebo
12467|NCT02647320|O1|Outcome|DS-8500a 25mg|One DS-8500a 25 mg tablet and placebo
12468|NCT02647320|O5|Outcome|Placebo|Placebo tablets and capsule
12469|NCT02647320|O4|Outcome|Sitagliptin 100 mg|One sitagliptin 100 mg over-capsule and placebo
12470|NCT02647320|O3|Outcome|DS-8500a 75 mg|Three DS-8500a 25 mg tablets and placebo
12471|NCT02647320|O2|Outcome|DS-8500a 50 mg|Two DS-8500a 25 mg tablets and placebo
12472|NCT02647320|O1|Outcome|DS-8500a 25mg|One DS-8500a 25 mg tablet and placebo
12473|NCT02647320|O5|Outcome|Placebo|Placebo tablets and capsule
12474|NCT02647320|O4|Outcome|Sitagliptin 100 mg|One sitagliptin 100 mg over-capsule and placebo
12475|NCT02647320|O3|Outcome|DS-8500a 75 mg|Three DS-8500a 25 mg tablets and placebo
12476|NCT02647320|O2|Outcome|DS-8500a 50 mg|Two DS-8500a 25 mg tablets and placebo
12477|NCT02647320|O1|Outcome|DS-8500a 25mg|One DS-8500a 25 mg tablet and placebo
12478|NCT02647320|O5|Outcome|Placebo|Placebo tablets and capsule
12479|NCT02647320|O4|Outcome|Sitagliptin 100 mg|One sitagliptin 100 mg over-capsule and placebo
12480|NCT02647320|O3|Outcome|DS-8500a 75 mg|Three DS-8500a 25 mg tablets and placebo
12481|NCT02647320|O2|Outcome|DS-8500a 50 mg|Two DS-8500a 25 mg tablets and placebo
12482|NCT02647320|O1|Outcome|DS-8500a 25mg|One DS-8500a 25 mg tablet and placebo
12483|NCT02647320|O5|Outcome|Placebo|Placebo tablets and capsule
12484|NCT02647320|O4|Outcome|Sitagliptin 100 mg|One sitagliptin 100 mg over-capsule and placebo
12485|NCT02647320|O3|Outcome|DS-8500a 75 mg|Three DS-8500a 25 mg tablets and placebo
12486|NCT02647320|O2|Outcome|DS-8500a 50 mg|Two DS-8500a 25 mg tablets and placebo
12487|NCT02647320|O1|Outcome|DS-8500a 25mg|One DS-8500a 25 mg tablet and placebo
12488|NCT02647320|O5|Outcome|Placebo|Placebo tablets and capsule
12489|NCT02647320|O4|Outcome|Sitagliptin 100 mg|One sitagliptin 100 mg over-capsule and placebo
12490|NCT02647320|O3|Outcome|DS-8500a 75 mg|Three DS-8500a 25 mg tablets and placebo
12491|NCT02647320|O2|Outcome|DS-8500a 50 mg|Two DS-8500a 25 mg tablets and placebo
12492|NCT02647320|O1|Outcome|DS-8500a 25mg|One DS-8500a 25 mg tablet and placebo
12493|NCT02647320|O5|Outcome|Placebo|Placebo tablets and capsule
20066|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
12498|NCT02647320|E5|Reported Event|Placebo|Three placebo tablets and one placebo capsule in a once-daily oral dose
12499|NCT02647320|E4|Reported Event|Sitagliptin 100 mg|Three placebo tablets and one sitagliptin 100 mg over-capsule in a once-daily oral dose
12500|NCT02647320|E3|Reported Event|DS-8500a 75 mg|Three DS-8500a 25 mg tablets and one placebo capsule in a once-daily oral dose
12501|NCT02647320|E2|Reported Event|DS-8500a 50 mg|Two DS-8500a 25 mg tablets, 1 placebo tablet, and one placebo capsule in a once-daily oral dose
12502|NCT02647320|E1|Reported Event|DS-8500a 25mg|One DS-8500a 25 mg tablet, 2 placebo tablets, and one placebo capsule in a once-daily oral dose
12503|NCT02646449|B3|Baseline|Total|Total of all reporting groups
12504|NCT02646449|B2|Baseline|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
12505|NCT02646449|B1|Baseline|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2."
12506|NCT02646449|P2|Participant Flow|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
12507|NCT02646449|P1|Participant Flow|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2."
12508|NCT02646449|O2|Outcome|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
12509|NCT02646449|O1|Outcome|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2."
12510|NCT02646449|O2|Outcome|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
12511|NCT02646449|O1|Outcome|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2."
12512|NCT02646449|E2|Reported Event|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
12513|NCT02646449|E1|Reported Event|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2."
12514|NCT02645760|B3|Baseline|Total|Total of all reporting groups
12515|NCT02645760|B2|Baseline|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
12516|NCT02645760|B1|Baseline|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles.
12517|NCT02645760|P2|Participant Flow|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
12518|NCT02645760|P1|Participant Flow|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) in
12539|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12519|NCT02645760|O2|Outcome|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
12520|NCT02645760|O1|Outcome|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) in
12521|NCT02645760|O2|Outcome|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
12522|NCT02645760|O1|Outcome|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) in
12523|NCT02645760|O2|Outcome|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
12524|NCT02645760|O1|Outcome|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles.
12525|NCT02645760|O2|Outcome|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
12526|NCT02645760|O1|Outcome|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles.
12527|NCT02645760|E2|Reported Event|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
12528|NCT02645760|E1|Reported Event|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles.
12529|NCT02645253|B5|Baseline|Total|Total of all reporting groups
12530|NCT02645253|B4|Baseline|Palcebo|Participants received placebo
12531|NCT02645253|B3|Baseline|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12532|NCT02645253|B2|Baseline|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12533|NCT02645253|B1|Baseline|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12534|NCT02645253|P4|Participant Flow|Palcebo|Participants received placebo
12535|NCT02645253|P3|Participant Flow|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12536|NCT02645253|P2|Participant Flow|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12537|NCT02645253|P1|Participant Flow|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12538|NCT02645253|O4|Outcome|Placebo|Participants received placebo.
12731|NCT02643394|B3|Baseline|Total|Total of all reporting groups
12540|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12541|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12542|NCT02645253|O4|Outcome|Placebo|Participants received placebo.
12543|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12544|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12545|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12546|NCT02645253|O4|Outcome|Placebo|Participants received placebo.
12547|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12548|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12549|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12550|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12551|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12552|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12553|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12554|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12555|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12556|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12557|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12558|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12559|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12560|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12561|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12562|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12563|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12564|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12565|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12566|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12567|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12568|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12569|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12570|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12571|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12572|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12573|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12574|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12575|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12576|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12577|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12578|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12579|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12580|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12581|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12582|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12583|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12584|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12585|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12586|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
20067|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
12587|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12588|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12589|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12590|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12591|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12592|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12593|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12594|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12595|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12596|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12597|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12598|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12599|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12600|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12601|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12602|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12603|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12604|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12605|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12606|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12607|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12608|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12609|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12610|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12611|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12612|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12613|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12614|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12615|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12616|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12617|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12618|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12619|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12620|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12621|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12622|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12623|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12624|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12625|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12626|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12627|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12628|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12629|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12630|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12631|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12632|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
17731|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
12633|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12634|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12635|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12636|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12637|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12638|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12639|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12640|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12641|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12642|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12643|NCT02645253|O6|Outcome|All Subjects|Total number of participants in the study.
12644|NCT02645253|O5|Outcome|Placebo|Participants who received placebo.
12645|NCT02645253|O4|Outcome|Total AZD7594|Overall number of participants who received treatment with AZD7594.
12646|NCT02645253|O3|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12647|NCT02645253|O2|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12648|NCT02645253|O1|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12649|NCT02645253|E6|Reported Event|All Subjects|Overall number of subjects who participated in the study.
12650|NCT02645253|E5|Reported Event|Total AZD7594|Overall number of subjects who received AZD7594 therapy.
12651|NCT02645253|E4|Reported Event|Palcebo|Participants received placebo
12652|NCT02645253|E3|Reported Event|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
12653|NCT02645253|E2|Reported Event|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
12654|NCT02645253|E1|Reported Event|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
12655|NCT02645123|B4|Baseline|Total|Total of all reporting groups
12656|NCT02645123|B3|Baseline|Classic Physiotherapy|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
12657|NCT02645123|B2|Baseline|Sham Treatment|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
12658|NCT02645123|B1|Baseline|Spinal Mobilization|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
12659|NCT02645123|P3|Participant Flow|Classic Physiotherapy|"This group received static hamstring stretch for 5 minutes, TENS (2 channels biphasic pulse, 90Hz, 100μs pulse width) for 20 minutes and 15 minutes of Swedish type massage (effleurage, petrissage, kneading)~Transcutaneous electrical nerve stimulation: Enraf-Nonius Sonopuls 692~swedish type massage: petrissage, effleurage, tapotement~muscle stretching: static hamstring stretching"
12660|NCT02645123|P2|Participant Flow|Sham Treatment|"The investigator touched the skin overlying the low back statically for 10 minutes~sham treatment: touching of the skin overlying the lumbar area"
12661|NCT02645123|P1|Participant Flow|Spinal Mobilization|"The individuals of the group received 5 treatments in total for 10 minutes that included: posterior to anterior spinal accessory mobilization passive physiological inter vertebral rotation The above was applied to the level that the MRI showed disc degeneration~spinal mobilization: passive physiological intervertebral movements and passive accessory posteroanterior mobilization"
12662|NCT02645123|O3|Outcome|Classic Physiotherapy|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
12663|NCT02645123|O2|Outcome|Sham Treatment|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
12664|NCT02645123|O1|Outcome|Spinal Mobilization|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
12665|NCT02645123|O3|Outcome|Classic Physiotherapy|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
12666|NCT02645123|O2|Outcome|Sham Treatment|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
13233|NCT02639338|B2|Baseline|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) tablet orally once daily without regard to food for 12 weeks
12667|NCT02645123|O1|Outcome|Spinal Mobilization|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
12668|NCT02645123|O3|Outcome|Classic Physiotherapy|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
12669|NCT02645123|O2|Outcome|Sham Treatment|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
12670|NCT02645123|O1|Outcome|Spinal Mobilization|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
12671|NCT02645123|O3|Outcome|Classic Physiotherapy|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
12672|NCT02645123|O2|Outcome|Sham Treatment|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
12673|NCT02645123|O1|Outcome|Spinal Mobilization|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
12674|NCT02645123|E3|Reported Event|Classic Physiotherapy|"This group received static hamstring stretch for 5 minutes, TENS (2 channels biphasic pulse, 90Hz, 100μs pulse width) for 20 minutes and 15 minutes of Swedish type massage (effleurage, petrissage, kneading)~Transcutaneous electrical nerve stimulation: Enraf-Nonius Sonopuls 692~swedish type massage: petrissage, effleurage, tapotement~muscle stretching: static hamstring stretching"
12675|NCT02645123|E2|Reported Event|Sham Treatment|"The investigator touched the skin overlying the low back statically for 10 minutes~sham treatment: touching of the skin overlying the lumbar area"
12676|NCT02645123|E1|Reported Event|Spinal Mobilization|"The individuals of the group received 5 treatments in total for 10 minutes that included: posterior to anterior spinal accessory mobilization passive physiological inter vertebral rotation The above was applied to the level that the MRI showed disc degeneration~spinal mobilization: passive physiological intervertebral movements and passive accessory posteroanterior mobilization"
12677|NCT02644356|B1|Baseline|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.~Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
12678|NCT02644356|P1|Participant Flow|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.~Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
12679|NCT02644356|O1|Outcome|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.~Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
12680|NCT02644356|O1|Outcome|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.~Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
12681|NCT02644356|O1|Outcome|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.~Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
12682|NCT02644356|O1|Outcome|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.~Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
12683|NCT02644356|O1|Outcome|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.~Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
12684|NCT02644356|O1|Outcome|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.~Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
12685|NCT02644356|O1|Outcome|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.~Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
12686|NCT02644356|E1|Reported Event|Online CE/CME Course|All subjects were assigned to take the three course modules of an online CE/CME course and complete pre- and post-course data collection. Module topics consisted of acupuncture, massage, and music-related interventions
12687|NCT02644109|B3|Baseline|Total|Total of all reporting groups
12688|NCT02644109|B2|Baseline|Placebo|"Milk powder: subjects will be instructed to consume 22 g/day of the product, without phytosterols. The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.~Drinking yoghurt: the daily volume consumed will be 90 ml/day without phytosterols. Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
12689|NCT02644109|B1|Baseline|Phytosterols|"Milk powder: subjects will be instructed to consume 22 g/day of the product, with 0.65 g of esterified phytosterols (0.39 g of free equivalent sterols). The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.~Drinking yoghurt: the daily volume consumed will be 90 ml/day with 1.3 grs of esterified phytosterols (0.78 g of free equivalent phytosterols). Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
12690|NCT02644109|P2|Participant Flow|Placebo|"Milk powder: subjects will be instructed to consume 22 g/day of the product, without phytosterols. The product will be reconstituted with 200 ml of water at time of consumption.~Drinking yoghurt: the daily volume consumed will be 90 ml/day without phytosterols.~Day 1: Anthropometry, laboratory test, dietary intake (24 hour recall and food frequency questionnaire) and presence of symptoms and side effects will be determined, a logbook will be provided to record product consumption, symptoms, medications and side effects. Then will be randomly assigned to one of the groups.~Days 7 & 21: 24 hour recall, review of symptoms, side effects and adherence as registered in the logbook.~Days 15 & 30: Anthropometry, vital signs, venous blood sample, review of symptoms, side effects and adherence to intervention as registered on logbook, dietary intake (24-hour recall), delivery of monetary compensation proportional to the study days will be given before being discharged."
12691|NCT02644109|P1|Participant Flow|Phytosterols|"Milk powder: subjects will consume 22 g/day of the product, with 0.65 g of esterified phytosterols (0.39 g of free equivalent sterols). The product will be reconstituted with 200 ml of water at time of consumption.~Drinking yoghurt: the daily volume consumed will be 90 ml/day with 1.3 grs of esterified phytosterols (0.78 g of free equivalent phytosterols).~Day 1: Anthropometry, laboratory test, dietary intake (24 hour recall and food frequency questionnaire), presence of symptoms and side effects will be determined. Then will be randomly assigned to one of the groups.~Days 7 & 21: 24 hour recall, review of symptoms, side effects and adherence as registered in the logbook.~Days 15 & 30: Anthropometry, vital signs, venous blood sample, review of symptoms, side effects and adherence to intervention as registered on logbook, dietary intake (24-hour recall), delivery of monetary compensation proportional to the study days will be given before being discharged."
12692|NCT02644109|O2|Outcome|Placebo|"Milk powder: subjects will be instructed to consume 22 g/day of the product, without phytosterols. The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.~Drinking yoghurt: the daily volume consumed will be 90 ml/day without phytosterols. Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
12693|NCT02644109|O1|Outcome|Phytosterols|"Milk powder: subjects will be instructed to consume 22 g/day of the product, with 0.65 g of esterified phytosterols (0.39 g of free equivalent sterols). The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.~Drinking yoghurt: the daily volume consumed will be 90 ml/day with 1.3 grs of esterified phytosterols (0.78 g of free equivalent phytosterols). Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
12694|NCT02644109|E2|Reported Event|Placebo|"Milk powder: subjects will be instructed to consume 22 g/day of the product, without phytosterols. The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.~Drinking yoghurt: the daily volume consumed will be 90 ml/day without phytosterols. Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
12695|NCT02644109|E1|Reported Event|Phytosterols|"Milk powder: subjects will be instructed to consume 22 g/day of the product, with 0.65 g of esterified phytosterols (0.39 g of free equivalent sterols). The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.~Drinking yoghurt: the daily volume consumed will be 90 ml/day with 1.3 grs of esterified phytosterols (0.78 g of free equivalent phytosterols). Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
12696|NCT02644096|B3|Baseline|Total|Total of all reporting groups
12697|NCT02644096|B2|Baseline|Intervention|"counselling and support after discharge from hospital~counselling and support after discharge from hospital: patients were contacted by telephone 2 times after discharge from surgery by a specialist nurse, who followed an interview guide due to nursing-rehabilitation after THR"
12698|NCT02644096|B1|Baseline|Conventional Treatment|After surgery, patients with total hip replacement are only seen once 3 months after surgery, and they have no further contact with the hospital.
12699|NCT02644096|P2|Participant Flow|Intervention|"counselling and support after discharge from hospital~counselling and support after discharge from hospital: patients were contacted by telephone 2 times after discharge from surgery by a specialist nurse, who followed an interview guide due to nursing-rehabilitation after THR"
12700|NCT02644096|P1|Participant Flow|Conventional Treatment|After surgery, patients with total hip replacement are only seen once 3 months after surgery, and they have no further contact with the hospital.
12701|NCT02644096|O2|Outcome|Intervention|"counselling and support after discharge from hospital~counselling and support after discharge from hospital: patients were contacted by telephone 2 times after discharge from surgery by a specialist nurse, who followed an interview guide due to nursing-rehabilitation.after THR."
12702|NCT02644096|O1|Outcome|Conventional Treatment|After surgery, patients with total hip replacement are only seen once 3 months after surgery, and they have no further contact with the hospital.
13234|NCT02639338|B1|Baseline|SOF/VEL/VOX 8 Weeks|SOF/VEL/VOX (400/100/100 mg) tablet orally once daily with food for 8 weeks
12703|NCT02644096|E2|Reported Event|Intervention|"counselling and support after discharge from hospital~counselling and support after discharge from hospital: patients were contacted by telephone 2 times after discharge from surgery by a specialist nurse, who followed an interview guide due to nursing-rehabilitation after THR."
12704|NCT02644096|E1|Reported Event|Conventional Treatment|After surgery, patients with total hip replacement are only seen once 3 months after surgery, and they have no further contact with the hospital.
12705|NCT02643862|B3|Baseline|Total|Total of all reporting groups
12706|NCT02643862|B2|Baseline|Placebo|"This is a placebo that looks similar to Xolair and is given as a subcutaneous shot, just like Xolair~Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria"
12707|NCT02643862|B1|Baseline|Xolair|"Pts will be randomized to receive xolair at a 3 active:1 placebo ratio~Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria"
12708|NCT02643862|P2|Participant Flow|Placebo|"This is a placebo that looks similar to Xolair and is given as a subcutaneous shot, just like Xolair~Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria"
12709|NCT02643862|P1|Participant Flow|Xolair|"Pts will be randomized to receive xolair at a 3 active:1 placebo ratio~Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria"
12710|NCT02643862|O2|Outcome|Placebo|"This is a placebo that looks similar to Xolair and is given as a subcutaneous shot, just like Xolair~Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria"
12711|NCT02643862|O1|Outcome|Xolair|"Pts will be randomized to receive xolair at a 3 active:1 placebo ratio~Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria"
12712|NCT02643862|O2|Outcome|Placebo|"This is a placebo that looks similar to Xolair and is given as a subcutaneous shot, just like Xolair~Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria"
12713|NCT02643862|O1|Outcome|Xolair|"Pts will be randomized to receive xolair at a 3 active:1 placebo ratio~Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria"
12714|NCT02643862|E2|Reported Event|Placebo|"This is a placebo that looks similar to Xolair and is given as a subcutaneous shot, just like Xolair~Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria"
12715|NCT02643862|E1|Reported Event|Xolair|"Pts will be randomized to receive xolair at a 3 active:1 placebo ratio~Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria"
12716|NCT02643615|B3|Baseline|Total|Total of all reporting groups
12717|NCT02643615|B2|Baseline|VEP Under Balanced Anesthesia|"Patients undergoing prone spine surgery will receive an anesthesia regimen using Desflurane as part of balanced general anesthesia~VEP under balanced anesth.: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.~Desflurane: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be ins"
12718|NCT02643615|B1|Baseline|VEP Under TIVA|"Patients undergoing prone spine surgery will receive an anesthesia regimen using propofol (TIVA) for maintenance~VEP under TIVA: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.~Propofol: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery."
12719|NCT02643615|P2|Participant Flow|VEP Under Balanced Anesthesia|"Patients undergoing prone spine surgery will receive an anesthesia regimen using Desflurane as part of balanced general anesthesia~VEP under balanced anesth.: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.~Desflurane: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery."
12720|NCT02643615|P1|Participant Flow|VEP Under TIVA|"Patients undergoing prone spine surgery will receive an anesthesia regimen using propofol (TIVA) for maintenance~VEP under TIVA: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.~Propofol: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery."
12721|NCT02643615|O2|Outcome|VEP Under Balanced Anesthesia|"Patients undergoing prone spine surgery will receive an anesthesia regimen using Desflurane as part of balanced general anesthesia~VEP under balanced anesth.: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.~Desflurane: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery."
12722|NCT02643615|O1|Outcome|VEP Under TIVA|"Patients undergoing prone spine surgery will receive an anesthesia regimen using propofol (TIVA) for maintenance~VEP under TIVA: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.~Propofol: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery."
12723|NCT02643615|O2|Outcome|VEP Under Balanced Anesthesia|"Patients undergoing prone spine surgery will receive an anesthesia regimen using Desflurane as part of balanced general anesthesia~VEP under balanced anesth.: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.~Desflurane: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery."
12724|NCT02643615|O1|Outcome|VEP Under TIVA|"Patients undergoing prone spine surgery will receive an anesthesia regimen using propofol (TIVA) for maintenance~VEP under TIVA: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.~Propofol: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery."
12725|NCT02643615|O2|Outcome|VEP Under Balanced Anesthesia|"Patients undergoing prone spine surgery will receive an anesthesia regimen using Desflurane as part of balanced general anesthesia~VEP under balanced anesth.: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.~Desflurane: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be ins"
12726|NCT02643615|O1|Outcome|VEP Under TIVA|"Patients undergoing prone spine surgery will receive an anesthesia regimen using propofol (TIVA) for maintenance~VEP under TIVA: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.~Propofol: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery."
12727|NCT02643615|O2|Outcome|VEP Under Balanced Anesthesia|"Patients undergoing prone spine surgery will receive an anesthesia regimen using Desflurane as part of balanced general anesthesia~VEP under balanced anesth.: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.~Desflurane: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be ins"
12728|NCT02643615|O1|Outcome|VEP Under TIVA|"Patients undergoing prone spine surgery will receive an anesthesia regimen using propofol (TIVA) for maintenance~VEP under TIVA: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.~Propofol: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery."
12729|NCT02643615|E2|Reported Event|VEP Under Balanced Anesthesia|"Patients undergoing prone spine surgery will receive an anesthesia regimen using Desflurane as part of balanced general anesthesia~VEP under balanced anesth.: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.~Desflurane: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be ins"
12730|NCT02643615|E1|Reported Event|VEP Under TIVA|"Patients undergoing prone spine surgery will receive an anesthesia regimen using propofol (TIVA) for maintenance~VEP under TIVA: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.~Propofol: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery."
12732|NCT02643394|B2|Baseline|Intravenous Acetaminophen|"Intravenous Acetaminophen within 1-hour prior to anesthetic emergence~Intravenous acetaminophen: 400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence."
12733|NCT02643394|B1|Baseline|Oral Acetaminophen|"Oral Acetaminophen 1-hour before surgery~Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision"
12734|NCT02643394|P2|Participant Flow|Intravenous Acetaminophen|"Intravenous Acetaminophen within 1-hour prior to anesthetic emergence~Intravenous acetaminophen: 400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence."
12735|NCT02643394|P1|Participant Flow|Oral Acetaminophen|"Oral Acetaminophen 1-hour before surgery~Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision"
12736|NCT02643394|O2|Outcome|Intravenous Acetaminophen|"Intravenous Acetaminophen within 1-hour prior to anesthetic emergence~Intravenous acetaminophen: 400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence."
12737|NCT02643394|O1|Outcome|Oral Acetaminophen|"Oral Acetaminophen 1-hour before surgery~Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision"
12738|NCT02643394|O2|Outcome|Intravenous Acetaminophen|"Intravenous Acetaminophen within 1-hour prior to anesthetic emergence~Intravenous acetaminophen: 400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence."
12739|NCT02643394|O1|Outcome|Oral Acetaminophen|"Oral Acetaminophen 1-hour before surgery~Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision"
12740|NCT02643394|E2|Reported Event|Intravenous Acetaminophen|"Intravenous Acetaminophen within 1-hour prior to anesthetic emergence~Intravenous acetaminophen: 400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence."
12741|NCT02643394|E1|Reported Event|Oral Acetaminophen|"Oral Acetaminophen 1-hour before surgery~Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision"
12742|NCT02643251|B3|Baseline|Total|Total of all reporting groups
12743|NCT02643251|B2|Baseline|Clonidine Hydrochloride Gel Comparator|"Clonidine Hydrochloride Gel Comparator~Clonidine Hydrochloride Gel Comparator: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use."
12744|NCT02643251|B1|Baseline|Clonidine Hydrochloride Topical Gel, 0.1%|"Clonidine Hydrochloride Topical Gel, 0.1%~Clonidine Hydrochloride Topical Gel, 0.1%: Clonidine Gel is supplied as an aqueous gel formulation for topical use."
12745|NCT02643251|P2|Participant Flow|Clonidine Hydrochloride Gel Comparator|"Clonidine Hydrochloride Gel Comparator~Clonidine Hydrochloride Gel Comparator: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use."
12746|NCT02643251|P1|Participant Flow|Clonidine Hydrochloride Topical Gel, 0.1%|"Clonidine Hydrochloride Topical Gel, 0.1%~Clonidine Hydrochloride Topical Gel, 0.1%: Clonidine Gel is supplied as an aqueous gel formulation for topical use."
12747|NCT02643251|O2|Outcome|Clonidine Hydrochloride Gel Comparator|"Clonidine Hydrochloride Gel Comparator~Clonidine Hydrochloride Gel Comparator: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use."
12748|NCT02643251|O1|Outcome|Clonidine Hydrochloride Topical Gel, 0.1%|"Clonidine Hydrochloride Topical Gel, 0.1%~Clonidine Hydrochloride Topical Gel, 0.1%: Clonidine Gel is supplied as an aqueous gel formulation for topical use."
12749|NCT02643251|O2|Outcome|Clonidine Hydrochloride Gel Comparator|"Clonidine Hydrochloride Gel Comparator~Clonidine Hydrochloride Gel Comparator: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use."
12750|NCT02643251|O1|Outcome|Clonidine Hydrochloride Topical Gel, 0.1%|"Clonidine Hydrochloride Topical Gel, 0.1%~Clonidine Hydrochloride Topical Gel, 0.1%: Clonidine Gel is supplied as an aqueous gel formulation for topical use."
12751|NCT02643251|E2|Reported Event|Clonidine Hydrochloride Gel Comparator|"Clonidine Hydrochloride Gel Comparator~Clonidine Hydrochloride Gel Comparator: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use."
12752|NCT02643251|E1|Reported Event|Clonidine Hydrochloride Topical Gel, 0.1%|"Clonidine Hydrochloride Topical Gel, 0.1%~Clonidine Hydrochloride Topical Gel, 0.1%: Clonidine Gel is supplied as an aqueous gel formulation for topical use."
12753|NCT02643225|B3|Baseline|Total|Total of all reporting groups
12754|NCT02643225|B2|Baseline|Non Diabetic Pregnant Women|"control group~The investigation will be performed to non diabetic pregnant women:~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
12755|NCT02643225|B1|Baseline|Pregnant Women With Gestational Diabetes|"case group The investigation will be performed to pregnant women with gestational diabetes~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
12756|NCT02643225|P2|Participant Flow|Non Diabetic Pregnant Women|"control group~The investigation will be performed to non diabetic pregnant women:~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed twice at 27-28 weeks and 36-37 weeks of gestation prospectively.~During ultrasound, fetal biometry (biparietal diameter, abdominal circumference, femur length) and estimated fetal weight will be calculated automatically according to hadlock’s formula additionally, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device.~The cross sectional area of Wharton’s jelly will be computed by subtracting the cross sectional area of the vessels from that of the umbilical cord and the interventricular septum thickness will be measured.~HbA1c levels will be measured for diabetes patients."
12757|NCT02643225|P1|Participant Flow|Pregnant Women With Gestational Diabetes|"case group~The investigation will be performed to pregnant women with gestational diabetes~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed twice at 27-28 weeks and 36-37 weeks of gestation prospectively.~During ultrasound, fetal biometry (biparietal diameter, abdominal circumference, femur length) and estimated fetal weight will be calculated automatically according to hadlock’s formula additionally, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device.~The cross sectional area of Wharton’s jelly will be computed by subtracting the cross sectional area of the vessels from that of the umbilical cord and the interventricular septum thickness will be measured.~HbA1c levels will be measured for diabetes patients."
12758|NCT02643225|O2|Outcome|Non Diabetic Pregnant Women|"control group~The investigation will be performed to non diabetic pregnant women:~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
12759|NCT02643225|O1|Outcome|Pregnant Women With Gestational Diabetes|"case group~The investigation will be performed to pregnant women with gestational diabetes~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
12760|NCT02643225|O2|Outcome|Non Diabetic Pregnant Women|"control group~The investigation will be performed to non diabetic pregnant women:~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
12761|NCT02643225|O1|Outcome|Pregnant Women With Gestational Diabetes|"case group~The investigation will be performed to pregnant women with gestational diabetes~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
12762|NCT02643225|O2|Outcome|Non Diabetic Pregnant Women|"control group~The investigation will be performed to non diabetic pregnant women:~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
12763|NCT02643225|O1|Outcome|Pregnant Women With Gestational Diabetes|"case group The investigation will be performed to pregnant women with gestational diabetes~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
12764|NCT02643225|O2|Outcome|Non Diabetic Pregnant Women|"control group~The investigation will be performed to non diabetic pregnant women:~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
12765|NCT02643225|O1|Outcome|Pregnant Women With Gestational Diabetes|"case group The investigation will be performed to pregnant women with gestational diabetes~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
12766|NCT02643225|E2|Reported Event|Non Diabetic Pregnant Women|"control group~The investigation will be performed to non diabetic pregnant women:~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
12797|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
12798|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
12799|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
12767|NCT02643225|E1|Reported Event|Pregnant Women With Gestational Diabetes|"case group~The investigation will be performed to pregnant women with gestational diabetes~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
12768|NCT02643199|B1|Baseline|Pregnant Women From 20 to 36 Weeks of Pregnancy|"This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.~90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria.~Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal Heart."
12769|NCT02643199|P1|Participant Flow|Pregnant Women From 20 to 36 Weeks of Pregnancy|"This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.~90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria.~Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal Heart."
12770|NCT02643199|O1|Outcome|Pregnant Women From 20 to 36 Weeks of Pregnancy|"This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.~90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria.~Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal Heart."
12771|NCT02643199|O1|Outcome|Pregnant Women From 20 to 36 Weeks of Pregnancy|"This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.~90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria.~Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal Heart."
12772|NCT02643199|E1|Reported Event|Pregnant Women From 20 to 36 Weeks of Pregnancy|"This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.~90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria.~Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal Heart."
12773|NCT02643004|B1|Baseline|Overall Baseline Characteristics|"Participants were randomized to wear senofilcon A or stenfilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens~Stenfilcon A: contact lens"
12774|NCT02643004|P2|Participant Flow|Stenfilcon A, Then Senofilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens~Senofilcon A: contact lens"
12775|NCT02643004|P1|Participant Flow|Senofilcon A, Then Stenfilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens~Stenfilcon A: contact lens"
12776|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
12777|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
12778|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
12779|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
12780|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
12781|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
12782|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
12783|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
12784|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
12785|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
12786|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
12787|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
12788|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
12789|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
12790|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
12791|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
12792|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
12793|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
12794|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
12795|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
12796|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
12874|NCT02642159|B3|Baseline|Total|Total of all reporting groups
12800|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
12801|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
12802|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
12803|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
12804|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
12805|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
12806|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
12807|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
12808|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
12809|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
12810|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
12811|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
12812|NCT02643004|E2|Reported Event|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
12813|NCT02643004|E1|Reported Event|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
12814|NCT02642835|B1|Baseline|Mesh Group|underwent anterior mesh for recurrent cystocele
12815|NCT02642835|P1|Participant Flow|Mesh Group|all had an anterior mesh for recurrent prolapse
12816|NCT02642835|O1|Outcome|Mesh Group|underwent anterior mesh for recurrent cystocele
12817|NCT02642835|O1|Outcome|Mesh Group|underwent anterior mesh for recurrent cystocele
12818|NCT02642835|O1|Outcome|Mesh Group|underwent anterior mesh for recurrent cystocele
12819|NCT02642835|O1|Outcome|Mesh Group|underwent anterior mesh for recurrent cystocele
12820|NCT02642835|O1|Outcome|Mesh Group|underwent anterior mesh for recurrent cystocele
12821|NCT02642835|O1|Outcome|Mesh Group|underwent anterior mesh for recurrent cystocele
12822|NCT02642835|O1|Outcome|Mesh Group|underwent anterior mesh for recurrent cystocele
12823|NCT02642835|O1|Outcome|Mesh Group|underwent anterior mesh for recurrent cystocele
12824|NCT02642835|O1|Outcome|Mesh Group|underwent anterior mesh for recurrent cystocele
12825|NCT02642835|O1|Outcome|Mesh Group|underwent anterior mesh for recurrent cystocele
12826|NCT02642835|E1|Reported Event|Mesh Group|underwent anterior mesh for recurrent cystocele
12827|NCT02642679|B1|Baseline|Opticell Ag|"Opticell Ag covered with a transparent occlusive dressing (Tegaderm) with evenly distributed perforations which permit a controlled leakage into a layer of cotton gauze pads placed directly over the Opticell Ag and occlusive dressing combination.~Opticell Ag: Opticell Ag+ applied to STSG donor site"
12828|NCT02642679|P1|Participant Flow|Opticell Ag|"Opticell Ag covered with a transparent occlusive dressing (Tegaderm) with evenly distributed perforations which permit a controlled leakage into a layer of cotton gauze pads placed directly over the Opticell Ag and occlusive dressing combination.~Opticell Ag: Opticell Ag+ applied to STSG donor site"
12829|NCT02642679|O1|Outcome|Opticell Ag|"Opticell Ag covered with a transparent occlusive dressing (Tegaderm) with evenly distributed perforations which permit a controlled leakage into a layer of cotton gauze pads placed directly over the Opticell Ag and occlusive dressing combination.~Opticell Ag: Opticell Ag+ applied to STSG donor site"
12830|NCT02642679|O1|Outcome|Opticell Ag|"Opticell Ag covered with a transparent occlusive dressing (Tegaderm) with evenly distributed perforations which permit a controlled leakage into a layer of cotton gauze pads placed directly over the Opticell Ag and occlusive dressing combination.~Opticell Ag: Opticell Ag+ applied to STSG donor site"
12831|NCT02642679|O1|Outcome|Opticell Ag|"Opticell Ag covered with a transparent occlusive dressing (Tegaderm) with evenly distributed perforations which permit a controlled leakage into a layer of cotton gauze pads placed directly over the Opticell Ag and occlusive dressing combination.~Opticell Ag: Opticell Ag+ applied to STSG donor site"
12832|NCT02642679|E1|Reported Event|Opticell Ag|"Opticell Ag covered with a transparent occlusive dressing (Tegaderm) with evenly distributed perforations which permit a controlled leakage into a layer of cotton gauze pads placed directly over the Opticell Ag and occlusive dressing combination.~Opticell Ag: Opticell Ag+ applied to STSG donor site"
12833|NCT02642575|B1|Baseline|Folliculometry in Women With Unexplained Infertility|67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) for ≥5 days starting from 5th day of the cycle then they will be scanned by the same physician using Two Dimensional Ultrasound then Five Dimensional Ultrasound.
12834|NCT02642575|P1|Participant Flow|Folliculometry in Women With Unexplained Infertility|67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) for ≥5 days starting from 5th day of the cycle then they will be scanned by the same physician using Two Dimensional Ultrasound then Five Dimensional Ultrasound.
12835|NCT02642575|O1|Outcome|Folliculometry in Women With Unexplained Infertility|67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) for ≥5 days starting from 5th day of the cycle then they will be scanned by the same physician using Two Dimensional Ultrasound then Five Dimensional Ultrasound.
17732|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
12836|NCT02642575|O1|Outcome|Folliculometry in Women With Unexplained Infertility|67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) for ≥5 days starting from 5th day of the cycle then they will be scanned by the same physician using Two Dimensional Ultrasound then Five Dimensional Ultrasound.
12837|NCT02642575|O1|Outcome|Folliculometry in Women With Unexplained Infertility|67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) for ≥5 days starting from 5th day of the cycle then they will be scanned by the same physician using Two Dimensional Ultrasound then Five Dimensional Ultrasound.
12838|NCT02642575|E1|Reported Event|Folliculometry in Women With Unexplained Infertility|67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) for ≥5 days starting from 5th day of the cycle then they will be scanned by the same physician using Two Dimensional Ultrasound then Five Dimensional Ultrasound.
12839|NCT02642536|B3|Baseline|Total|Total of all reporting groups
12840|NCT02642536|B2|Baseline|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.~Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
12841|NCT02642536|B1|Baseline|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions~MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
12842|NCT02642536|P2|Participant Flow|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.~Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
12843|NCT02642536|P1|Participant Flow|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 10 phone based clinician led CBT sessions~MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 10 phone based clinician led CBT sessions"
12844|NCT02642536|O2|Outcome|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.~Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
12845|NCT02642536|O1|Outcome|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions~MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
12846|NCT02642536|O2|Outcome|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.~Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
12847|NCT02642536|O1|Outcome|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions~MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
12848|NCT02642536|O2|Outcome|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.~Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
12849|NCT02642536|O1|Outcome|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions~MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
12850|NCT02642536|O2|Outcome|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.~Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
12851|NCT02642536|O1|Outcome|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions~MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
12852|NCT02642536|O2|Outcome|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.~Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
12875|NCT02642159|B2|Baseline|Usual Care|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks.
20068|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
12853|NCT02642536|O1|Outcome|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions~MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
12854|NCT02642536|O2|Outcome|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.~Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
12855|NCT02642536|O1|Outcome|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions~MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
12856|NCT02642536|O2|Outcome|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.~Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
12857|NCT02642536|O1|Outcome|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions~MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
12858|NCT02642536|O2|Outcome|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.~Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
12859|NCT02642536|O1|Outcome|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions~MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
12860|NCT02642536|O2|Outcome|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.~Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
12861|NCT02642536|O1|Outcome|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions~MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
12862|NCT02642536|O2|Outcome|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.~Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
12863|NCT02642536|O1|Outcome|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions~MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
12864|NCT02642536|O2|Outcome|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.~Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
12865|NCT02642536|O1|Outcome|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions~MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
12866|NCT02642536|E2|Reported Event|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.~Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
12867|NCT02642536|E1|Reported Event|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions~MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
12868|NCT02642432|B1|Baseline|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
12869|NCT02642432|P1|Participant Flow|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
12870|NCT02642432|O1|Outcome|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
12871|NCT02642432|O1|Outcome|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
12872|NCT02642432|O1|Outcome|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
12873|NCT02642432|E1|Reported Event|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
12876|NCT02642159|B1|Baseline|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
12877|NCT02642159|P2|Participant Flow|Usual Care|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks.
12878|NCT02642159|P1|Participant Flow|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg subcutaneous (SC) injection every 2 weeks (Q2W) added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other lipid modifying therapies (LMT) for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-high-density lipoprotein cholesterol (non-HDL-C) levels >=100 mg/dL (2.59 mmol/L) at Week 8.
12879|NCT02642159|O2|Outcome|Usual Care|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks.
12880|NCT02642159|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
12881|NCT02642159|O2|Outcome|Usual Care|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks.
12882|NCT02642159|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
12883|NCT02642159|O2|Outcome|Usual Care|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks.
12884|NCT02642159|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
12885|NCT02642159|O2|Outcome|Usual Care: Intent to Prescribe Fenofibrate|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks.
12886|NCT02642159|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
12887|NCT02642159|O2|Outcome|Usual Care|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks.
12888|NCT02642159|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
12889|NCT02642159|O2|Outcome|Usual Care: Intent to Prescribe Fenofibrate|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks.
12890|NCT02642159|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
12891|NCT02642159|O2|Outcome|Usual Care|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks.
12892|NCT02642159|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
12893|NCT02642159|O2|Outcome|Usual Care: Intent to Prescribe Fenofibrate|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks.
12894|NCT02642159|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
12895|NCT02642159|O2|Outcome|Usual Care|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks.
12896|NCT02642159|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
12897|NCT02642159|O2|Outcome|Usual Care: Intent to Prescribe Fenofibrate|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks.
13235|NCT02639338|P2|Participant Flow|SOF/VEL 12 Weeks|Sofosbuvir/Velpatasvir (Epclusa®; SOF/VEL) (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
12898|NCT02642159|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
12899|NCT02642159|O2|Outcome|Usual Care|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks.
12900|NCT02642159|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
12901|NCT02642159|O2|Outcome|Usual Care: Intent to Prescribe Fenofibrate|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks.
12902|NCT02642159|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
12903|NCT02642159|O2|Outcome|Usual Care|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks.
12904|NCT02642159|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
12905|NCT02642159|O2|Outcome|Usual Care: Intent to Prescribe Fenofibrate|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks.
12906|NCT02642159|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
12907|NCT02642159|O2|Outcome|Usual Care|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks.
12908|NCT02642159|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
12909|NCT02642159|O2|Outcome|Usual Care: Intent to Prescribe Fenofibrate|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks.
12910|NCT02642159|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
12911|NCT02642159|O2|Outcome|Usual Care|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks.
12912|NCT02642159|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
12913|NCT02642159|O2|Outcome|Usual Care: Intent to Prescribe Fenofibrate|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks.
12914|NCT02642159|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
12915|NCT02642159|O2|Outcome|Usual Care|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks.
12916|NCT02642159|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
12917|NCT02642159|O2|Outcome|Usual Care: Intent to Prescribe Fenofibrate|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks.
12918|NCT02642159|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
12919|NCT02642159|O2|Outcome|Usual Care|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks.
12920|NCT02642159|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
12921|NCT02642159|O2|Outcome|Usual Care: Intent to Prescribe Fenofibrate|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks.
12922|NCT02642159|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
12923|NCT02642159|O2|Outcome|Usual Care|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks.
12924|NCT02642159|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
12925|NCT02642159|E2|Reported Event|Usual Care|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator’s judgment for 24 weeks.
12926|NCT02642159|E1|Reported Event|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
12927|NCT02641912|B3|Baseline|Total|Total of all reporting groups
12928|NCT02641912|B2|Baseline|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
12929|NCT02641912|B1|Baseline|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
12930|NCT02641912|P2|Participant Flow|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
12931|NCT02641912|P1|Participant Flow|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 milliliter (mL) of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
12932|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
12933|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
12934|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
12935|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
12936|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
12937|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
12938|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
12939|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
12940|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
12941|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
12942|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
12943|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
13238|NCT02639338|O1|Outcome|SOF/VEL/VOX 8 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
12944|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
12945|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
12946|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
12947|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
12948|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
12949|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
12950|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
12951|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
12952|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
12953|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
12954|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
12955|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
12956|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
12957|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
12958|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
12959|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
12960|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drunken water as often as required. Participants consumed their own water for home use.
12961|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were used per day.
12962|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drunken water as often as required. Participants consumed their own water for home use.
12963|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were used per day.
12964|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drunken water as often as required. Participants consumed their own water for home use.
12965|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were used per day.
12966|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drunken water as often as required. Participants consumed their own water for home use.
12990|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
12967|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were used per day.
12968|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drunken water as often as required. Participants consumed their own water for home use.
12969|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were used per day.
12970|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
12971|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
12972|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
12973|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
12974|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
12975|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
12976|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
12977|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
12978|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
12979|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
12980|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
12981|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
12982|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
12983|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
12984|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
12985|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
12986|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
12987|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
12988|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
12989|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
13236|NCT02639338|P1|Participant Flow|SOF/VEL/VOX 8 Weeks|Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi®; SOF/VEL/VOX) (400/100/100 mg) fixed dose combination (FDC) tablet orally once daily with food for 8 weeks
12991|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
12992|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
12993|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
12994|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
12995|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
12996|NCT02641912|E2|Reported Event|Mineral Water|During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
12997|NCT02641912|E1|Reported Event|Experimental Mouthwash|During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
12998|NCT02641561|B5|Baseline|Total|Total of all reporting groups
12999|NCT02641561|B4|Baseline|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
13000|NCT02641561|B3|Baseline|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
13001|NCT02641561|B2|Baseline|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
13002|NCT02641561|B1|Baseline|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
13003|NCT02641561|P4|Participant Flow|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
13004|NCT02641561|P3|Participant Flow|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
13005|NCT02641561|P2|Participant Flow|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
13006|NCT02641561|P1|Participant Flow|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
13237|NCT02639338|O2|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
20069|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
13007|NCT02641561|O4|Outcome|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
13008|NCT02641561|O3|Outcome|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
13009|NCT02641561|O2|Outcome|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
13010|NCT02641561|O1|Outcome|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
13011|NCT02641561|O4|Outcome|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
13012|NCT02641561|O3|Outcome|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
13013|NCT02641561|O2|Outcome|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
13014|NCT02641561|O1|Outcome|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
13015|NCT02641561|O4|Outcome|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
13016|NCT02641561|O3|Outcome|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
13017|NCT02641561|O2|Outcome|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
13018|NCT02641561|O1|Outcome|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
13207|NCT02640404|O1|Outcome|Menactra® Vaccine (9 to 23 Months)|Participants (infants and toddlers) received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 3-month interval (first dose at Day 0 and second dose, 3 months after dose 1).
13019|NCT02641561|O4|Outcome|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
13020|NCT02641561|O3|Outcome|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
13021|NCT02641561|O2|Outcome|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
13022|NCT02641561|O1|Outcome|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
13023|NCT02641561|O4|Outcome|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
13024|NCT02641561|O3|Outcome|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
13025|NCT02641561|O2|Outcome|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
13026|NCT02641561|O1|Outcome|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
13027|NCT02641561|O4|Outcome|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
13028|NCT02641561|O3|Outcome|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
13029|NCT02641561|O2|Outcome|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
13030|NCT02641561|O1|Outcome|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
13208|NCT02640404|E2|Reported Event|Menactra® Vaccine (2 to 55 Years)|Participants (children, adolescents and adults) received 1 dose of 0.5 mL Menactra® Vaccine, intramuscularly at Day 0.
13286|NCT02638493|B2|Baseline|HIV Negative|8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis
13031|NCT02641561|O4|Outcome|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
13032|NCT02641561|O3|Outcome|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
13033|NCT02641561|O2|Outcome|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
13034|NCT02641561|O1|Outcome|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
13035|NCT02641561|O4|Outcome|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
13036|NCT02641561|O3|Outcome|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
13037|NCT02641561|O2|Outcome|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
13038|NCT02641561|O1|Outcome|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
13039|NCT02641561|O4|Outcome|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
13040|NCT02641561|O3|Outcome|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
13041|NCT02641561|O2|Outcome|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
13042|NCT02641561|O1|Outcome|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
13209|NCT02640404|E1|Reported Event|Menactra® Vaccine (9 to 23 Months)|Participants (infants and toddlers) received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 3-month interval (first dose at Day 0 and second dose, 3 months after dose 1).
13043|NCT02641561|O4|Outcome|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
13044|NCT02641561|O3|Outcome|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
13045|NCT02641561|O2|Outcome|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
13046|NCT02641561|O1|Outcome|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
13047|NCT02641561|O4|Outcome|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
13048|NCT02641561|O3|Outcome|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
13049|NCT02641561|O2|Outcome|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
13050|NCT02641561|O1|Outcome|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
13051|NCT02641561|O4|Outcome|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
13052|NCT02641561|O3|Outcome|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
13053|NCT02641561|O2|Outcome|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
13054|NCT02641561|O1|Outcome|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
13210|NCT02640157|B4|Baseline|Total|Total of all reporting groups
13211|NCT02640157|B3|Baseline|Arm C|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
13287|NCT02638493|B1|Baseline|HIV Positive TDF/FTC|8 HIV positive men taking TDF/FTC as treatment
13055|NCT02641561|O4|Outcome|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
13056|NCT02641561|O3|Outcome|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
13057|NCT02641561|O2|Outcome|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
13058|NCT02641561|O1|Outcome|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
13059|NCT02641561|O4|Outcome|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
13060|NCT02641561|O3|Outcome|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
13061|NCT02641561|O2|Outcome|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
13062|NCT02641561|O1|Outcome|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
13063|NCT02641561|O4|Outcome|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
13064|NCT02641561|O3|Outcome|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
13065|NCT02641561|O2|Outcome|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
13066|NCT02641561|O1|Outcome|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
13212|NCT02640157|B2|Baseline|Arm B|Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks.
13213|NCT02640157|B1|Baseline|Arm A|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
13067|NCT02641561|O4|Outcome|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
13068|NCT02641561|O3|Outcome|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
13069|NCT02641561|O2|Outcome|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
13070|NCT02641561|O1|Outcome|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
13071|NCT02641561|O4|Outcome|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
13072|NCT02641561|O3|Outcome|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
13073|NCT02641561|O2|Outcome|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
13074|NCT02641561|O1|Outcome|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
13075|NCT02641561|O4|Outcome|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
13076|NCT02641561|O3|Outcome|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
13077|NCT02641561|O2|Outcome|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
13078|NCT02641561|O1|Outcome|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
13214|NCT02640157|P3|Participant Flow|Arm C|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
13215|NCT02640157|P2|Participant Flow|Arm B|Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks.
13079|NCT02641561|O4|Outcome|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
13080|NCT02641561|O3|Outcome|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
13081|NCT02641561|O2|Outcome|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
13082|NCT02641561|O1|Outcome|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
13083|NCT02641561|O4|Outcome|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
13084|NCT02641561|O3|Outcome|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
13085|NCT02641561|O2|Outcome|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
13086|NCT02641561|O1|Outcome|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
13087|NCT02641561|E4|Reported Event|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
13088|NCT02641561|E3|Reported Event|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer’s solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It’s composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
13089|NCT02641561|E2|Reported Event|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
13090|NCT02641561|E1|Reported Event|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
13091|NCT02641379|B12|Baseline|Total|Total of all reporting groups
13216|NCT02640157|P1|Participant Flow|Arm A|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
13092|NCT02641379|B11|Baseline|PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)|Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
13093|NCT02641379|B10|Baseline|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (</= 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
13094|NCT02641379|B9|Baseline|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
13095|NCT02641379|B8|Baseline|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
13096|NCT02641379|B7|Baseline|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13097|NCT02641379|B6|Baseline|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13098|NCT02641379|B5|Baseline|PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)|Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
13099|NCT02641379|B4|Baseline|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
13100|NCT02641379|B3|Baseline|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
13101|NCT02641379|B2|Baseline|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13102|NCT02641379|B1|Baseline|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13103|NCT02641379|P11|Participant Flow|PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)|Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
13217|NCT02640157|O3|Outcome|Arm C|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
13104|NCT02641379|P10|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (≤ 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
13105|NCT02641379|P9|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
13106|NCT02641379|P8|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
13107|NCT02641379|P7|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (≥ 15 IU/ml, TaqMan® HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13108|NCT02641379|P6|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (≥ 15 IU/ml, TaqMan® HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13109|NCT02641379|P5|Participant Flow|PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)|Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
13110|NCT02641379|P4|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a rapid virological response (RVR) at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
13111|NCT02641379|P3|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (≥ 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
13112|NCT02641379|P2|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13113|NCT02641379|P1|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received pegylated interferon alpha-2a (PEG-IFN alfa-2a) at a dose of 180 microgram (mcg) subcutaneously (SC) once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 milligram/day (mg/day) [for participants with a body weight </= 75 kilogram (kg)] or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an early virological response (EVR) defined as non-detectable serum hepatitis C virus ribonucleic acid (HCV RNA) [< 600 international units/milliliter (IU/ml)] by quantitative polymerase chain reaction (PCR) or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13114|NCT02641379|O6|Outcome|PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)|Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
13218|NCT02640157|O2|Outcome|Arm B|Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks.
13219|NCT02640157|O1|Outcome|Arm A|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
13115|NCT02641379|O5|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (</= 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
13116|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
13117|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
13118|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13119|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13120|NCT02641379|O5|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (</= 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
13121|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
13122|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
13123|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13124|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13125|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
13220|NCT02640157|O3|Outcome|Arm C|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
13221|NCT02640157|O2|Outcome|Arm B|Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks.
13222|NCT02640157|O1|Outcome|Arm A|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
13126|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13127|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13128|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
13129|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13130|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13131|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
13132|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
13133|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
13134|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
13135|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13136|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13223|NCT02640157|O2|Outcome|Arm B|Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks.
13224|NCT02640157|O1|Outcome|Arm A|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
20070|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
13137|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13138|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13139|NCT02641379|O5|Outcome|PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)|Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
13140|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
13141|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
13142|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13143|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13144|NCT02641379|O5|Outcome|PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)|Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
13145|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
13146|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
13147|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13225|NCT02640157|O2|Outcome|Arm C|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
13148|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13149|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13150|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13151|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13152|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13153|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
13154|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
13155|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13156|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13157|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
13226|NCT02640157|O1|Outcome|Arm A|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
13227|NCT02640157|O2|Outcome|Arm B|Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks.
13228|NCT02640157|O1|Outcome|Arm A|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
13158|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
13159|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13160|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13161|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml) and negative HCV RNA level at Week 8 (≤ 15 IU/ml) were assigned to group E. Participants had a treatment-free follow-up period of 24 weeks.
13162|NCT02641379|O2|Outcome|PEG-IFN Alfa 2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13163|NCT02641379|O1|Outcome|PEG-IFN Alfa 2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13164|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13165|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13166|NCT02641379|E11|Reported Event|PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)|Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
13167|NCT02641379|E10|Reported Event|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (</= 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
13168|NCT02641379|E9|Reported Event|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
13229|NCT02640157|E3|Reported Event|ARM C|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
17733|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
13169|NCT02641379|E8|Reported Event|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
13170|NCT02641379|E7|Reported Event|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13171|NCT02641379|E6|Reported Event|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13172|NCT02641379|E5|Reported Event|PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)|Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
13173|NCT02641379|E4|Reported Event|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
13174|NCT02641379|E3|Reported Event|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
13175|NCT02641379|E2|Reported Event|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13176|NCT02641379|E1|Reported Event|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
13177|NCT02641249|B1|Baseline|All Subjects|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.~Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
13178|NCT02641249|P1|Participant Flow|All Subjects|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.~Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
13179|NCT02641249|O2|Outcome|Vibration|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.~Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
13230|NCT02640157|E2|Reported Event|ARM B|Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks.
13231|NCT02640157|E1|Reported Event|Arm A|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
13232|NCT02639338|B3|Baseline|Total|Total of all reporting groups
13180|NCT02641249|O1|Outcome|No Vibration|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.~Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
13181|NCT02641249|O2|Outcome|Vibration|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.~Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
13182|NCT02641249|O1|Outcome|No Vibration|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.~Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
13183|NCT02641249|O2|Outcome|Vibration|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.~Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
13184|NCT02641249|O1|Outcome|No Vibration|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.~Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
13185|NCT02641249|E1|Reported Event|All Subjects|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.~Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
13186|NCT02640482|B3|Baseline|Total|Total of all reporting groups
13187|NCT02640482|B2|Baseline|Arm B DB Placebo Then OL Active Drug|Placebo for ABT-493/ABT-530 QD for 12 weeks (DB treatment period) followed by ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (open-label [OL] treatment period)
13188|NCT02640482|B1|Baseline|Arm A DB Active Drug|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind [DB] treatment period)
13189|NCT02640482|P2|Participant Flow|Arm B DB Placebo Then OL Active Drug|Placebo for ABT-493/ABT-530 QD for 12 weeks (DB treatment period) followed by ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (open-label [OL] treatment period)
13190|NCT02640482|P1|Participant Flow|Arm A DB Active Drug|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind [DB] treatment period)
13191|NCT02640482|O1|Outcome|Arm A DB Active Drug|Arm A DB Active Drug: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind [DB] treatment period)
13192|NCT02640482|O1|Outcome|Arm A DB Active Drug|Arm A DB Active Drug: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind [DB] treatment period)
13193|NCT02640482|O1|Outcome|Arm A DB Active Drug|Arm A DB Active Drug: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind [DB] treatment period)
13194|NCT02640482|O1|Outcome|Arm A DB Active Drug|Arm A DB Active Drug: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind [DB] treatment period)
13195|NCT02640482|O1|Outcome|Arm A DB Active Drug|Arm A DB Active Drug: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind [DB] treatment period)
13196|NCT02640482|E3|Reported Event|Arm B OL Active Drug|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (open-label [OL] treatment period)
13197|NCT02640482|E2|Reported Event|Arm B DB Placebo|Placebo for ABT-493/ABT-530 QD for 12 weeks (DB treatment period)
13198|NCT02640482|E1|Reported Event|Arm A DB Active Drug|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind [DB] treatment period)
13199|NCT02640404|B3|Baseline|Total|Total of all reporting groups
13200|NCT02640404|B2|Baseline|Menactra® Vaccine (2 to 55 Years)|Participants (children, adolescents and adults) received 1 dose of 0.5 mL Menactra® Vaccine, intramuscularly at Day 0.
13201|NCT02640404|B1|Baseline|Menactra® Vaccine (9 to 23 Months)|Participants (infants and toddlers) received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 3-month interval (first dose at Day 0 and second dose, 3 months after dose 1).
13202|NCT02640404|P2|Participant Flow|Menactra® Vaccine (2 to 55 Years)|Participants (children, adolescents and adults) received 1 dose of 0.5 mL Menactra® Vaccine, intramuscularly at Day 0.
13203|NCT02640404|P1|Participant Flow|Menactra® Vaccine (9 to 23 Months)|Participants (infants and toddlers) received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 3-month interval (first dose at Day 0 and second dose, 3 months after dose 1).
13204|NCT02640404|O1|Outcome|Menactra® Vaccine (2 to 55 Years)|Participants (children, adolescents and adults) received 1 dose of 0.5 mL Menactra® Vaccine, intramuscularly at Day 0.
13205|NCT02640404|O1|Outcome|Menactra® Vaccine (9 to 23 Months)|Participants (infants and toddlers) received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 3-month interval (first dose at Day 0 and second dose, 3 months after dose 1).
13206|NCT02640404|O1|Outcome|Menactra® Vaccine (2 to 55 Years)|Participants (children, adolescents and adults) received 1 dose of 0.5 mL Menactra® Vaccine, intramuscularly at Day 0.
13239|NCT02639338|O2|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
13240|NCT02639338|O1|Outcome|SOF/VEL/VOX 8 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
13241|NCT02639338|O2|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
13242|NCT02639338|O1|Outcome|SOF/VEL/VOX 8 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
13243|NCT02639338|O2|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
13244|NCT02639338|O1|Outcome|SOF/VEL/VOX 8 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
13245|NCT02639338|O2|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
13246|NCT02639338|O1|Outcome|SOF/VEL/VOX 8 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
13247|NCT02639338|O2|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
13248|NCT02639338|O1|Outcome|SOF/VEL/VOX 8 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
13249|NCT02639338|E2|Reported Event|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
13250|NCT02639338|E1|Reported Event|SOF/VEL/VOX 8 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
13251|NCT02639247|B3|Baseline|Total|Total of all reporting groups
13252|NCT02639247|B2|Baseline|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
13253|NCT02639247|B1|Baseline|SOF/VEL/VOX 12 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
13254|NCT02639247|P2|Participant Flow|SOF/VEL 12 Weeks|Sofosbuvir/Velpatasvir (Epclusa®; SOF/VEL) (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
13255|NCT02639247|P1|Participant Flow|SOF/VEL/VOX 12 Weeks|Sofosbuvir/veltapasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) (400/100/100 mg) fixed-dose combination (FDC) tablet orally once daily with food for 12 weeks
13256|NCT02639247|O2|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
13257|NCT02639247|O1|Outcome|SOF/VEL/VOX 12 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
13258|NCT02639247|O2|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
13259|NCT02639247|O1|Outcome|SOF/VEL/VOX 12 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
13260|NCT02639247|O2|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
13261|NCT02639247|O1|Outcome|SOF/VEL/VOX 12 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
13262|NCT02639247|O2|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
13263|NCT02639247|O1|Outcome|SOF/VEL/VOX 12 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
13264|NCT02639247|O2|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
13265|NCT02639247|O1|Outcome|SOF/VEL/VOX 12 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
13266|NCT02639247|O2|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
13267|NCT02639247|O1|Outcome|SOF/VEL/VOX 12 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
13268|NCT02639247|E2|Reported Event|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
13269|NCT02639247|E1|Reported Event|SOF/VEL/VOX 12 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
13270|NCT02639052|B1|Baseline|Botox and Saline Vehicle Control|"10 units of both Botox and a saline vehicle will be intradermally injected into one forearm or the other on the first study visit. The subject will be blinded to which forearm receives the Botox and which forearm receives the saline vehicle.~Botox: 10 units of Botox will be intradermally injected into one 4x4cm area on the volar forearm on 1st study visit.~Saline: 10 units of the Saline vehicle will be intradermally injected into one 4x4cm area on the contralateral volar forearm on the 1st study visit."
13271|NCT02639052|P1|Participant Flow|Botox and Saline Vehicle Control|"10 units of both Botox and a saline vehicle will be intradermally injected into one forearm or the other on the first study visit. The subject will be blinded to which forearm receives the Botox and which forearm receives the saline vehicle.~Botox: 10 units of Botox will be intradermally injected into one 4x4cm area on the volar forearm on 1st study visit.~Saline: 10 units of the Saline vehicle will be intradermally injected into one 4x4cm area on the contralateral volar forearm on the 1st study visit."
13272|NCT02639052|O2|Outcome|Saline|Saline vehicle intradermally injected into the other forearm
13273|NCT02639052|O1|Outcome|Botox|10 units of Botox intradermally injected into one forearm
13274|NCT02639052|O2|Outcome|Saline|Saline vehicle intradermally injected into the other forearm
13275|NCT02639052|O1|Outcome|Botox|10 units of Botox intradermally injected into one forearm
13276|NCT02639052|O2|Outcome|Saline|Saline vehicle intradermally injected into the other forearm
13277|NCT02639052|O1|Outcome|Botox|10 units of Botox intradermally injected into one forearm
13278|NCT02639052|O2|Outcome|Saline|Saline vehicle intradermally injected into the other forearm
13279|NCT02639052|O1|Outcome|Botox|10 units of Botox intradermally injected into one forearm
13280|NCT02639052|O2|Outcome|Saline|Saline vehicle intradermally injected into the other forearm
13281|NCT02639052|O1|Outcome|Botox|10 units of Botox intradermally injected into one forearm
13282|NCT02639052|E2|Reported Event|Saline|Saline vehicle intradermally injected into the other forearm
13283|NCT02639052|E1|Reported Event|Botox|10 units of Botox intradermally injected into one forearm
13284|NCT02638493|B4|Baseline|Total|Total of all reporting groups
13285|NCT02638493|B3|Baseline|HIV Positive TAF|8 HIV positive men taking TAF as treatment
20071|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
13288|NCT02638493|P3|Participant Flow|HIV Positive TAF|8 HIV positive men taking TAF (Tenofovir Alafenamide) as treatment
13289|NCT02638493|P2|Participant Flow|HIV Negative|8 HIV negative men taking TDF/FTC (Tenofovir Disoproxil Fumarate/Emtricitabine) as pre-exposure prophylaxis
13290|NCT02638493|P1|Participant Flow|HIV Positive TDF/FTC|8 HIV positive men taking TDF/FTC (Tenofovir Disoproxil Fumarate/Emtricitabine) as treatment
13291|NCT02638493|O3|Outcome|HIV Positive TAF|8 HIV positive men taking TAF as treatment
13292|NCT02638493|O2|Outcome|HIV Negative|8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis
13293|NCT02638493|O1|Outcome|HIV Positive TDF/FTC|8 HIV positive men taking TDF/FTC as treatment
13294|NCT02638493|O3|Outcome|HIV Positive TAF|8 HIV positive men taking TAF as treatment
13295|NCT02638493|O2|Outcome|HIV Negative|8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis
13296|NCT02638493|O1|Outcome|HIV Positive TDF/FTC|8 HIV positive men taking TDF/FTC as treatment
13297|NCT02638493|O3|Outcome|HIV Positive TAF|8 HIV positive men taking TAF as treatment
13298|NCT02638493|O2|Outcome|HIV Negative|8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis
13299|NCT02638493|O1|Outcome|HIV Positive TDF/FTC|8 HIV positive men taking TDF/FTC as treatment
13300|NCT02638493|O3|Outcome|HIV Positive TAF|8 HIV positive men taking TAF as treatment
13301|NCT02638493|O2|Outcome|HIV Negative|8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis
13302|NCT02638493|O1|Outcome|HIV Positive TDF/FTC|8 HIV positive men taking TDF/FTC as treatment
13303|NCT02638493|O3|Outcome|HIV Positive TAF|8 HIV positive men taking TAF as treatment
13304|NCT02638493|O2|Outcome|HIV Negative|8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis
13305|NCT02638493|O1|Outcome|HIV Positive TDF/FTC|8 HIV positive men taking TDF/FTC as treatment
13306|NCT02638493|O3|Outcome|HIV Positive TAF|8 HIV positive men taking TAF as treatment
13307|NCT02638493|O2|Outcome|HIV Negative|8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis
13308|NCT02638493|O1|Outcome|HIV Positive TDF/FTC|8 HIV positive men taking TDF/FTC as treatment
13309|NCT02638493|O3|Outcome|HIV Positive TAF|8 HIV positive men taking TAF as treatment
13310|NCT02638493|O2|Outcome|HIV Negative|8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis
13311|NCT02638493|O1|Outcome|HIV Positive TDF/FTC|8 HIV positive men taking TDF/FTC as treatment
13312|NCT02638493|O3|Outcome|HIV Positive TAF|8 HIV positive men taking TAF as treatment
13313|NCT02638493|O2|Outcome|HIV Negative|8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis
13314|NCT02638493|O1|Outcome|HIV Positive TDF/FTC|8 HIV positive men taking TDF/FTC as treatment
13315|NCT02638493|E3|Reported Event|HIV Positive TAF|8 HIV positive men taking TAF as treatment
13316|NCT02638493|E2|Reported Event|HIV Negative|8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis
13317|NCT02638493|E1|Reported Event|HIV Positive TDF/FTC|8 HIV positive men taking TDF/FTC as treatment
13318|NCT02638259|B3|Baseline|Total|Total of all reporting groups
13319|NCT02638259|B2|Baseline|50mg EU-authorized Enbrel - Switched to GP2015|"Group 2 will receive treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response will be switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2).~GP2015: Enbrel comparator"
13320|NCT02638259|B1|Baseline|50mg GP2015 - Continued|"Group 1 will receive treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continue treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2).~GP2015: Enbrel comparator"
13321|NCT02638259|P2|Participant Flow|50mg EU-authorized Enbrel - Switched to GP2015|"Group 2 will receive treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response will be switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2).~GP2015: Enbrel comparator"
13322|NCT02638259|P1|Participant Flow|50mg GP2015 - Continued|"Group 1 will receive treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continue treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2).~GP2015: Enbrel comparator"
13323|NCT02638259|O2|Outcome|50 mg EU-authorized Enbrel|"Group 2 will receive treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response will be switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2).~GP2015: Enbrel comparator"
13324|NCT02638259|O1|Outcome|50 mg GP2015|"Group 1 will receive treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continue treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2).~GP2015: Enbrel comparator"
13325|NCT02638259|O2|Outcome|50 mg EU-authorized Enbrel|"Group 2 will receive treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response will be switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2).~GP2015: Enbrel comparator"
13326|NCT02638259|O1|Outcome|50 mg GP2015|"Group 1 will receive treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continue treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2).~GP2015: Enbrel comparator"
13327|NCT02638259|O2|Outcome|50mg EU-authorized Enbrel|"Group 2 will receive treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response will be switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2).~GP2015: Enbrel comparator"
13382|NCT02637999|O2|Outcome|MXB + PEG IFN Then PEG IFN|Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by pegINF 180mcg once weekly for 24 weeks
17734|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
13328|NCT02638259|O1|Outcome|50mg GP2015|"Group 1 will receive treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continue treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2).~GP2015: Enbrel comparator"
13329|NCT02638259|E2|Reported Event|50 mg EU-authorized Enbrel|"Group 2 will receive treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response will be switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2).~GP2015: Enbrel comparator"
13330|NCT02638259|E1|Reported Event|50 mg GP2015|"Group 1 will receive treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continue treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2).~GP2015: Enbrel comparator"
13331|NCT02638129|B3|Baseline|Total|Total of all reporting groups
13332|NCT02638129|B2|Baseline|Placebo|"Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets"
13333|NCT02638129|B1|Baseline|Naltrexone/Bupropion|"Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets"
13334|NCT02638129|P2|Participant Flow|Placebo|"Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets"
13335|NCT02638129|P1|Participant Flow|Naltrexone/Bupropion|"Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets"
13336|NCT02638129|O2|Outcome|Placebo|"Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets"
13337|NCT02638129|O1|Outcome|Naltrexone/Bupropion|"Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets"
13338|NCT02638129|O2|Outcome|Placebo|"Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets"
13339|NCT02638129|O1|Outcome|Naltrexone/Bupropion|"Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets"
13340|NCT02638129|O2|Outcome|Placebo|"Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets"
13353|NCT02638051|O2|Outcome|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.~IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
13515|NCT02637323|E1|Reported Event|FX006 32 mg|"Single 5 mL intra-articular injection~FX006: Sustained Release Steroid"
13341|NCT02638129|O1|Outcome|Naltrexone/Bupropion|"Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets"
13342|NCT02638129|O2|Outcome|Placebo|"Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets"
13343|NCT02638129|O1|Outcome|Naltrexone/Bupropion|"Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets"
13344|NCT02638129|E2|Reported Event|Placebo|"Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets"
13345|NCT02638129|E1|Reported Event|Naltrexone/Bupropion|"Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets"
13346|NCT02638051|B3|Baseline|Total|Total of all reporting groups
13347|NCT02638051|B2|Baseline|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.~IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
13348|NCT02638051|B1|Baseline|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.~Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.~TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
13349|NCT02638051|P2|Participant Flow|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter was occluded. Administered biweekly during four weeks of the course, totally two times.~IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
13350|NCT02638051|P1|Participant Flow|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.~Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.~TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
13351|NCT02638051|O2|Outcome|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.~IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
13352|NCT02638051|O1|Outcome|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.~Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.~TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
13354|NCT02638051|O1|Outcome|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.~Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.~TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
13355|NCT02638051|O2|Outcome|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.~IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
13356|NCT02638051|O1|Outcome|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.~Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.~TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
13357|NCT02638051|E2|Reported Event|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.~IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
13358|NCT02638051|E1|Reported Event|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.~Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.~TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
13359|NCT02637999|B4|Baseline|Total|Total of all reporting groups
13360|NCT02637999|B3|Baseline|PEG IFN|PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
13361|NCT02637999|B2|Baseline|MXB + PEG IFN Then PEG IFN|Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks
13362|NCT02637999|B1|Baseline|MXB Then PEG IFN|Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
13363|NCT02637999|P3|Participant Flow|PEG IFN|PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
13364|NCT02637999|P2|Participant Flow|MXB + PEG IFN Then PEG IFN|Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks
13365|NCT02637999|P1|Participant Flow|MXB Then PEG IFN|Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
13366|NCT02637999|O3|Outcome|PEG IFN|PEG IFN alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
13367|NCT02637999|O2|Outcome|MXB + PEG IFN Then PEG IFN|Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by pegINF 180mcg once weekly for 24 weeks
13368|NCT02637999|O1|Outcome|MXB Then PEG IFN|Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
13369|NCT02637999|O3|Outcome|PEG IFN|PEG IFN alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
13370|NCT02637999|O2|Outcome|MXB + PEG IFN Then PEG IFN|Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by pegINF 180mcg once weekly for 24 weeks
13371|NCT02637999|O1|Outcome|MXB Then PEG IFN|Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
13372|NCT02637999|O3|Outcome|PEG IFN|PEG IFN alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
13373|NCT02637999|O2|Outcome|MXB + PEG IFN Then PEG IFN|Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by pegINF 180mcg once weekly for 24 weeks
13374|NCT02637999|O1|Outcome|MXB Then PEG IFN|Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
13375|NCT02637999|O3|Outcome|PEG IFN|PEG IFN alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
13376|NCT02637999|O2|Outcome|MXB + PEG IFN Then PEG IFN|Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by pegINF 180mcg once weekly for 24 weeks
13377|NCT02637999|O1|Outcome|MXB Then PEG IFN|Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
13378|NCT02637999|O3|Outcome|PEG IFN|PEG IFN alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
13379|NCT02637999|O2|Outcome|MXB + PEG IFN Then PEG IFN|Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by pegINF 180mcg once weekly for 24 weeks
13380|NCT02637999|O1|Outcome|MXB Then PEG IFN|Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
13381|NCT02637999|O3|Outcome|PEG IFN|PEG IFN alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
13383|NCT02637999|O1|Outcome|MXB Then PEG IFN|Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
13385|NCT02637999|O2|Outcome|MXB + PEG IFN Then PEG IFN|Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by pegINF 180mcg once weekly for 24 weeks
13386|NCT02637999|O1|Outcome|MXB Then PEG IFN|Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
13387|NCT02637999|O3|Outcome|PEG IFN|PEG IFN alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
13388|NCT02637999|O2|Outcome|MXB + PEG IFN Then PEG IFN|Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by pegINF 180mcg once weekly for 24 weeks
13389|NCT02637999|O1|Outcome|MXB Then PEG IFN|Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
13390|NCT02637999|O3|Outcome|PEG IFN|PEG IFN alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
13391|NCT02637999|O2|Outcome|MXB + PEG IFN Then PEG IFN|Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by pegINF 180mcg once weekly for 24 weeks
13392|NCT02637999|O1|Outcome|MXB Then PEG IFN|Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
13393|NCT02637999|E3|Reported Event|PEG IFN|PEG IFN alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
13394|NCT02637999|E2|Reported Event|MXB + PEG IFN Then PEG IFN|Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by pegINF 180mcg once weekly for 24 weeks
13395|NCT02637999|E1|Reported Event|MXB Then PEG IFN|Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
13396|NCT02637804|B3|Baseline|Total|Total of all reporting groups
13397|NCT02637804|B2|Baseline|Overall Characteristics - Group 2: Stenfilcon A & Delefilcon A|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13398|NCT02637804|B1|Baseline|Overall Characteristics - Group 1:Stenfilcon A & Narafilcon A|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13399|NCT02637804|P4|Participant Flow|Delefilcon A, Then Stenfilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13400|NCT02637804|P3|Participant Flow|Stenfilcon A, Then Delefilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13401|NCT02637804|P2|Participant Flow|Narafilcon A, Then Stenfilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13402|NCT02637804|P1|Participant Flow|Stenfilcon A, Then Narafilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13403|NCT02637804|O4|Outcome|Delefilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13404|NCT02637804|O3|Outcome|Stenfilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13405|NCT02637804|O2|Outcome|Narafilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13406|NCT02637804|O1|Outcome|Stenfilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13407|NCT02637804|O4|Outcome|Delefilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13408|NCT02637804|O3|Outcome|Stenfilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13409|NCT02637804|O2|Outcome|Narafilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13410|NCT02637804|O1|Outcome|Stenfilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13411|NCT02637804|O4|Outcome|Delefilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13412|NCT02637804|O3|Outcome|Stenfilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13413|NCT02637804|O2|Outcome|Narafilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13414|NCT02637804|O1|Outcome|Stenfilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13415|NCT02637804|O4|Outcome|Delefilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13416|NCT02637804|O3|Outcome|Stenfilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13516|NCT02637063|B4|Baseline|Total|Total of all reporting groups
13417|NCT02637804|O2|Outcome|Narafilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13418|NCT02637804|O1|Outcome|Stenfilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13419|NCT02637804|O4|Outcome|Delefilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13420|NCT02637804|O3|Outcome|Stenfilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13421|NCT02637804|O2|Outcome|Narafilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13422|NCT02637804|O1|Outcome|Stenfilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13423|NCT02637804|O4|Outcome|Delefilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13424|NCT02637804|O3|Outcome|Stenfilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13425|NCT02637804|O2|Outcome|Narafilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13426|NCT02637804|O1|Outcome|Stenfilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13427|NCT02637804|O4|Outcome|Delefilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13428|NCT02637804|O3|Outcome|Stenfilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13429|NCT02637804|O2|Outcome|Narafilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13430|NCT02637804|O1|Outcome|Stenfilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13431|NCT02637804|O4|Outcome|Delefilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13432|NCT02637804|O3|Outcome|Stenfilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13433|NCT02637804|O2|Outcome|Narafilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13434|NCT02637804|O1|Outcome|Stenfilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13435|NCT02637804|O4|Outcome|Delefilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13436|NCT02637804|O3|Outcome|Stenfilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13437|NCT02637804|O2|Outcome|Narafilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13438|NCT02637804|O1|Outcome|Stenfilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13439|NCT02637804|O4|Outcome|Delefilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13440|NCT02637804|O3|Outcome|Stenfilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13441|NCT02637804|O2|Outcome|Narafilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13442|NCT02637804|O1|Outcome|Stenfilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13443|NCT02637804|O4|Outcome|Delefilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13444|NCT02637804|O3|Outcome|Stenfilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13589|NCT02637037|O3|Outcome|Treatment C|Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
13445|NCT02637804|O2|Outcome|Narafilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13446|NCT02637804|O1|Outcome|Stenfilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13447|NCT02637804|O4|Outcome|Delefilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13448|NCT02637804|O3|Outcome|Stenfilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13449|NCT02637804|O2|Outcome|Narafilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13450|NCT02637804|O1|Outcome|Stenfilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13451|NCT02637804|O4|Outcome|Delefilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13452|NCT02637804|O3|Outcome|Stenfilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13453|NCT02637804|O2|Outcome|Narafilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13454|NCT02637804|O1|Outcome|Stenfilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13455|NCT02637804|O4|Outcome|Delefilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13456|NCT02637804|O3|Outcome|Stenfilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13457|NCT02637804|O2|Outcome|Narafilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13458|NCT02637804|O1|Outcome|Stenfilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13459|NCT02637804|O4|Outcome|Delefilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13460|NCT02637804|O3|Outcome|Stenfilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13461|NCT02637804|O2|Outcome|Narafilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13462|NCT02637804|O1|Outcome|Stenfilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13463|NCT02637804|O5|Outcome|Prefer Delefilcon A|delefilcon A: contact lens
13464|NCT02637804|O4|Outcome|Little Prefer Delefilcon A|delefilcon A: contact lens
13465|NCT02637804|O3|Outcome|No Preference|No Preference
13466|NCT02637804|O2|Outcome|Little Prefer Stenfilcon A|stenfilcon A: contact lens
13467|NCT02637804|O1|Outcome|Prefer Stenfilcon A|stenfilcon A: contact lens
13468|NCT02637804|O5|Outcome|Prefer Narafilcon A|narafilcon A: contact lens
13469|NCT02637804|O4|Outcome|Little Prefer Narafilcon A|narafilcon A: contact lens
13470|NCT02637804|O3|Outcome|No Preference|No Preference
13471|NCT02637804|O2|Outcome|Little Prefer Stenfilcon A|stenfilcon A: contact lens
13472|NCT02637804|O1|Outcome|Prefer Stenfilcon A|stenfilcon A: contact lens
13473|NCT02637804|O4|Outcome|Delefilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13474|NCT02637804|O3|Outcome|Stenfilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13475|NCT02637804|O2|Outcome|Narafilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13476|NCT02637804|O1|Outcome|Stenfilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13477|NCT02637804|O4|Outcome|Delefilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13478|NCT02637804|O3|Outcome|Stenfilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13479|NCT02637804|O2|Outcome|Narafilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13480|NCT02637804|O1|Outcome|Stenfilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13481|NCT02637804|O4|Outcome|Delefilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13482|NCT02637804|O3|Outcome|Stenfilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13483|NCT02637804|O2|Outcome|Narafilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13484|NCT02637804|O1|Outcome|Stenfilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13485|NCT02637804|O4|Outcome|Delefilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13486|NCT02637804|O3|Outcome|Stenfilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13487|NCT02637804|O2|Outcome|Narafilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13488|NCT02637804|O1|Outcome|Stenfilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13489|NCT02637804|O4|Outcome|Delefilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13490|NCT02637804|O3|Outcome|Stenfilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13491|NCT02637804|O2|Outcome|Narafilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13492|NCT02637804|O1|Outcome|Stenfilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13493|NCT02637804|O4|Outcome|Delefilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13494|NCT02637804|O3|Outcome|Stenfilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13495|NCT02637804|O2|Outcome|Narafilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13496|NCT02637804|O1|Outcome|Stenfilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13497|NCT02637804|O4|Outcome|Delefilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13498|NCT02637804|O3|Outcome|Stenfilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
13499|NCT02637804|O2|Outcome|Narafilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13500|NCT02637804|O1|Outcome|Stenfilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
13501|NCT02637804|E4|Reported Event|Delefilcon A (Group 2)|Participants randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week then cross over.
13502|NCT02637804|E3|Reported Event|Stenfilcon A (Group 2)|Participants randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week then cross over.
13503|NCT02637804|E2|Reported Event|Narafilcon A (Group1)|Participants randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week then cross over.
13504|NCT02637804|E1|Reported Event|Stenfilcon A (Group 1)|Participants randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week then cross over.
13505|NCT02637323|B3|Baseline|Total|Total of all reporting groups
13506|NCT02637323|B2|Baseline|TCA IR 40 mg|Single 1 mL IA injection
13507|NCT02637323|B1|Baseline|FX006 32 mg|Single 5 mL IA injection
13508|NCT02637323|P2|Participant Flow|TCA IR 40 mg|18 subjects received TCA IR 40 mg as a single 1 mL IA injection
13509|NCT02637323|P1|Participant Flow|FX006 32 mg|63 subjects received FX006 32 mg as a single 5 mL IA injection
13510|NCT02637323|O2|Outcome|TCA IR 40 mg|Single 1 mL IA injection
13511|NCT02637323|O1|Outcome|FX006 32 mg|Single 5mL IA injection
13512|NCT02637323|O2|Outcome|TCA IR 40 mg|Single 1 mL IA injection
13513|NCT02637323|O1|Outcome|FX006 32 mg|Single 5 mL IA injection
13514|NCT02637323|E2|Reported Event|TCA IR 40 mg|"Commercially available triamcinolone acetonide, single 1 mL intra-articular injection~TCA IR: Immediate Release Steroid"
17735|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
13517|NCT02637063|B3|Baseline|Usual Care|"No intervention beyond the participants' personal medical care.~Usual care: No intervention beyond participants' own medical care."
13518|NCT02637063|B2|Baseline|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
13519|NCT02637063|B1|Baseline|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
13520|NCT02637063|P3|Participant Flow|Usual Care|"No intervention beyond the participants' personal medical care.~Usual care: No intervention beyond participants' own medical care."
13521|NCT02637063|P2|Participant Flow|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
13522|NCT02637063|P1|Participant Flow|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
13523|NCT02637063|O3|Outcome|Usual Care|"No intervention beyond the participants' personal medical care.~Usual care: No intervention beyond participants' own medical care."
13524|NCT02637063|O2|Outcome|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
13525|NCT02637063|O1|Outcome|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
13526|NCT02637063|O3|Outcome|Usual Care|"No intervention beyond the participants' personal medical care.~Usual care: No intervention beyond participants' own medical care."
13527|NCT02637063|O2|Outcome|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
13528|NCT02637063|O1|Outcome|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
13529|NCT02637063|O3|Outcome|Usual Care|"No intervention beyond the participants' personal medical care.~Usual care: No intervention beyond participants' own medical care."
13530|NCT02637063|O2|Outcome|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
13531|NCT02637063|O1|Outcome|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
13532|NCT02637063|O3|Outcome|Usual Care|"No intervention beyond the participants' personal medical care.~Usual care: No intervention beyond participants' own medical care."
13533|NCT02637063|O2|Outcome|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
13534|NCT02637063|O1|Outcome|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
13535|NCT02637063|O3|Outcome|Usual Care|"No intervention beyond the participants' personal medical care.~Usual care: No intervention beyond participants' own medical care."
13536|NCT02637063|O2|Outcome|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
13537|NCT02637063|O1|Outcome|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
13538|NCT02637063|O3|Outcome|Usual Care|"No intervention beyond the participants' personal medical care.~Usual care: No intervention beyond participants' own medical care."
13539|NCT02637063|O2|Outcome|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
13540|NCT02637063|O1|Outcome|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
13541|NCT02637063|O3|Outcome|Usual Care|"No intervention beyond the participants' personal medical care.~Usual care: No intervention beyond participants' own medical care."
13542|NCT02637063|O2|Outcome|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
13543|NCT02637063|O1|Outcome|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
13544|NCT02637063|E3|Reported Event|Usual Care|"No intervention beyond the participants' personal medical care.~Usual care: No intervention beyond participants' own medical care."
13545|NCT02637063|E2|Reported Event|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
13546|NCT02637063|E1|Reported Event|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
13547|NCT02637037|B3|Baseline|Total|Total of all reporting groups
13548|NCT02637037|B2|Baseline|Part 2|Sequences 1, 2, 3 and 4 - each sequence had 10 subjects Part 2: EFGH, FEHG, EFHG, FEGH (E = test, fed; F = reference, fed; G = test, fasted; H = reference, fasted) Part 2: Test: Dapagliflozin/metformin XR manufactured at Mount Vernon plant (1 x 10/1000 mg); Reference: Dapagliflozin/metformin XR manufactured at Humacao plant (1 x 10/1000 mg)
13549|NCT02637037|B1|Baseline|Part 1|Sequences 1, 2, 3 and 4- each sequence had 10 subjects; Part 1: ABCD, BADC, ABDC, BACD (A = test, fed; B = reference, fed; C = test, fasted; D = reference, fasted) Part 1: Test: Dapagliflozin/metformin XR mg manufactured at Mount Vernon plant (1 x 5/500 mg); Reference: Dapagliflozin/metformin XR mg manufactured at Humacao plant (1 x 5/500 mg)
13550|NCT02637037|P2|Participant Flow|Part 2|Sequences 1, 2, 3 and 4 - each sequence had 10 subjects Part 2: EFGH, FEHG, EFHG, FEGH (E = test, fed; F = reference, fed; G = test, fasted; H = reference, fasted) Part 2: Test: Dapagliflozin/metformin XR manufactured at Mount Vernon plant (1 x 10/1000 mg); Reference: Dapagliflozin/metformin XR manufactured at Humacao plant (1 x 10/1000 mg)
13551|NCT02637037|P1|Participant Flow|Part 1|Sequences 1, 2, 3 and 4- each sequence had 10 subjects; Part 1: ABCD, BADC, ABDC, BACD (A = test, fed; B = reference, fed; C = test, fasted; D = reference, fasted) Part 1: Test: Dapagliflozin/metformin XR mg manufactured at Mount Vernon plant (1 x 5/500 mg); Reference: Dapagliflozin/metformin XR mg manufactured at Humacao plant (1 x 5/500 mg)
13552|NCT02637037|O8|Outcome|Treatment H|Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
13553|NCT02637037|O7|Outcome|Treatment G|Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
13554|NCT02637037|O6|Outcome|Treatment F|Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
13555|NCT02637037|O5|Outcome|Treatment E|Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
13556|NCT02637037|O4|Outcome|Treatment D|Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
13557|NCT02637037|O3|Outcome|Treatment C|Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
13558|NCT02637037|O2|Outcome|Treatment B|Fed - 5/500 mg - Dapagliflozin/metformin XR mg manufactured at Humacao plant
13559|NCT02637037|O1|Outcome|Treatment A|Fed - 5/500 mg - Dapagliflozin/metformin XR mg manufactured at Mount Vernon plant
13560|NCT02637037|O8|Outcome|Treatment H|Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
13561|NCT02637037|O7|Outcome|Treatment G|Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
13562|NCT02637037|O6|Outcome|Treatment F|Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
13563|NCT02637037|O5|Outcome|Treatment E|Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
13564|NCT02637037|O4|Outcome|Treatment D|Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
13565|NCT02637037|O3|Outcome|Treatment C|Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
13566|NCT02637037|O2|Outcome|Treatment B|Fed - 5/500 mg - Dapagliflozin/metformin XR mg manufactured at Humacao plant
13567|NCT02637037|O1|Outcome|Treatment A|Fed - 5/500 mg - Dapagliflozin/metformin XR mg manufactured at Mount Vernon plant
13568|NCT02637037|O8|Outcome|Treatment H|Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
13569|NCT02637037|O7|Outcome|Treatment G|Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
13570|NCT02637037|O6|Outcome|Treatment F|Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
13571|NCT02637037|O5|Outcome|Treatment E|Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
13572|NCT02637037|O4|Outcome|Treatment D|Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
13573|NCT02637037|O3|Outcome|Treatment C|Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
13574|NCT02637037|O2|Outcome|Treatment B|Fed - 5/500 mg - Dapagliflozin/metformin XR mg manufactured at Humacao plant
13575|NCT02637037|O1|Outcome|Treatment A|Fed - 5/500 mg - Dapagliflozin/metformin XR mg manufactured at Mount Vernon plant
13576|NCT02637037|O8|Outcome|Treatment H|Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
13577|NCT02637037|O7|Outcome|Treatment G|Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
13578|NCT02637037|O6|Outcome|Treatment F|Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
13579|NCT02637037|O5|Outcome|Treatment E|Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
13580|NCT02637037|O4|Outcome|Treatment D|Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
13581|NCT02637037|O3|Outcome|Treatment C|Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
13582|NCT02637037|O2|Outcome|Treatment B|Fed - 5/500 mg - Dapagliflozin/metformin XR mg manufactured at Humacao plant
13583|NCT02637037|O1|Outcome|Treatment A|Fed - 5/500 mg - Dapagliflozin/metformin XR mg manufactured at Mount Vernon plant
13584|NCT02637037|O8|Outcome|Treatment H|Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
13585|NCT02637037|O7|Outcome|Treatment G|Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
13586|NCT02637037|O6|Outcome|Treatment F|Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
13587|NCT02637037|O5|Outcome|Treatment E|Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
13588|NCT02637037|O4|Outcome|Treatment D|Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
17736|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
13590|NCT02637037|O2|Outcome|Treatment B|Fed - 5/500 mg - Dapagliflozin/metformin XR mg manufactured at Humacao plant
13591|NCT02637037|O1|Outcome|Treatment A|Fed - 5/500 mg - Dapagliflozin/metformin XR mg manufactured at Mount Vernon plant
13592|NCT02637037|O8|Outcome|Treatment H|Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
13593|NCT02637037|O7|Outcome|Treatment G|Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
13594|NCT02637037|O6|Outcome|Treatment F|Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
13595|NCT02637037|O5|Outcome|Treatment E|Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
13596|NCT02637037|O4|Outcome|Treatment D|Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
13597|NCT02637037|O3|Outcome|Treatment C|Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
13598|NCT02637037|O2|Outcome|Treatment B|Fed - 5/500 mg - Dapagliflozin/metformin XR mg manufactured at Humacao plant
13599|NCT02637037|O1|Outcome|Treatment A|Fed - 5/500 mg - Dapagliflozin/metformin XR mg manufactured at Mount Vernon plant
13600|NCT02637037|O8|Outcome|Treatment H|Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
13601|NCT02637037|O7|Outcome|Treatment G|Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
13602|NCT02637037|O6|Outcome|Treatment F|Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
13603|NCT02637037|O5|Outcome|Treatment E|Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
13604|NCT02637037|O4|Outcome|Treatment D|Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
13605|NCT02637037|O3|Outcome|Treatment C|Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
13606|NCT02637037|O2|Outcome|Treatment B|Fed - 5/500 mg - Dapagliflozin/metformin XR mg manufactured at Humacao plant
13607|NCT02637037|O1|Outcome|Treatment A|Fed - 5/500 mg - Dapagliflozin/metformin XR mg manufactured at Mount Vernon plant
13608|NCT02637037|E8|Reported Event|Treatment H|Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
13609|NCT02637037|E7|Reported Event|Treatment G|Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
13610|NCT02637037|E6|Reported Event|Treatment F|Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
13611|NCT02637037|E5|Reported Event|Treatment E|Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
13612|NCT02637037|E4|Reported Event|Treatment D|Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
13613|NCT02637037|E3|Reported Event|Treatment C|Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
13614|NCT02637037|E2|Reported Event|Treatment B|Fed - 5/500 mg - Dapagliflozin/metformin XR mg manufactured at Humacao plant
13615|NCT02637037|E1|Reported Event|Treatment A|Fed - 5/500 mg - Dapagliflozin/metformin XR mg manufactured at Mount Vernon plant
13616|NCT02636907|B1|Baseline|BI 695501|BI 695501 solution for injection, 40 mg/0.8 mL, administered by subcutaneous injection every 2 weeks by autoinjector.
13617|NCT02636907|P1|Participant Flow|BI 695501|BI 695501 solution for injection, 40 mg/0.8 mL, administered by subcutaneous injection every 2 weeks by autoinjector.
13618|NCT02636907|O1|Outcome|BI 695501|BI 695501 solution for injection, 40 mg/0.8 mL, administered by subcutaneous injection every 2 weeks by autoinjector.
13619|NCT02636907|O1|Outcome|BI 695501|BI 695501 solution for injection, 40 mg/0.8 mL, administered by subcutaneous injection every 2 weeks by autoinjector.
13620|NCT02636907|O1|Outcome|BI 695501|BI 695501 solution for injection, 40 mg/0.8 mL, administered by subcutaneous injection every 2 weeks by autoinjector.
13621|NCT02636907|O1|Outcome|BI 695501|BI 695501 solution for injection, 40 mg/0.8 mL, administered by subcutaneous injection every 2 weeks by autoinjector.
13622|NCT02636907|E1|Reported Event|BI 695501|BI 695501 solution for injection, 40 mg/0.8 mL, administered by subcutaneous injection every 2 weeks by autoinjector.
13623|NCT02636595|B1|Baseline|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
13624|NCT02636595|P1|Participant Flow|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
13625|NCT02636595|O1|Outcome|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
13626|NCT02636595|O1|Outcome|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
13627|NCT02636595|O1|Outcome|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
13628|NCT02636595|E1|Reported Event|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
13629|NCT02635828|B1|Baseline|Triple Therapy PONV Prohylaxis|"At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis.~Palonosetron 0.075 mg IV: At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.~Dexamethasone 10 mg IV: At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.~Promethazine 25 mg IV: At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis."
13630|NCT02635828|P1|Participant Flow|Triple Therapy PONV Prohylaxis|"At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis.~Palonosetron 0.075 mg IV: At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.~Dexamethasone 10 mg IV: At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.~Promethazine 25 mg IV: At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis."
13631|NCT02635828|O1|Outcome|Triple Therapy PONV Prohylaxis|"At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis.~Palonosetron 0.075 mg IV: At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.~Dexamethasone 10 mg IV: At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.~Promethazine 25 mg IV: At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis."
13679|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
13632|NCT02635828|O1|Outcome|Triple Therapy PONV Prohylaxis|"At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis.~Palonosetron 0.075 mg IV: At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.~Dexamethasone 10 mg IV: At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.~Promethazine 25 mg IV: At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis."
13633|NCT02635828|E1|Reported Event|Triple Therapy PONV Prohylaxis|"At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis.~Palonosetron 0.075 mg IV: At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.~Dexamethasone 10 mg IV: At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.~Promethazine 25 mg IV: At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis."
13634|NCT02635425|B3|Baseline|Total|Total of all reporting groups
13635|NCT02635425|B2|Baseline|Full Eggs Collection|"Aspiration of all eggs~Full eggs collection: vaginal US"
13636|NCT02635425|B1|Baseline|7 Eggs Collection|"Aspiration of 7 eggs only~7 eggs collection: vaginal US"
13637|NCT02635425|P2|Participant Flow|Full Eggs Collection|"Aspiration of all eggs~Full eggs collection: vaginal US"
13638|NCT02635425|P1|Participant Flow|7 Eggs Collection|"Aspiration of 7 eggs only~7 eggs collection: vaginal US"
13639|NCT02635425|O2|Outcome|Full Eggs Collection|"Aspiration of all eggs~Full eggs collection: vaginal US"
13640|NCT02635425|O1|Outcome|7 Eggs Collection|"Aspiration of 7 eggs only~7 eggs collection: vaginal US"
13641|NCT02635425|E2|Reported Event|Full Eggs Collection|"Aspiration of all eggs~Full eggs collection: vaginal US"
13642|NCT02635425|E1|Reported Event|7 Eggs Collection|"Aspiration of 7 eggs only~7 eggs collection: vaginal US"
13643|NCT02635204|B3|Baseline|Total|Total of all reporting groups
13644|NCT02635204|B2|Baseline|Vehicle Cream|Participants received Vehicle Cream and was applied twice daily for 14 days.
13645|NCT02635204|B1|Baseline|DFD-06 Cream|Participants applied DFD-06 Cream twice daily for 14 days.
13646|NCT02635204|P2|Participant Flow|Vehicle Cream|Vehicle Cream was applied to subjects with moderate plaque psoriasis twice daily for 14 days.
13647|NCT02635204|P1|Participant Flow|DFD-06 Cream|DFD-06 Cream was applied to subjects with moderate plaque psoriasis twice daily for 14 days.
13648|NCT02635204|O2|Outcome|Vehicle Cream|Participants received Vehicle Cream applied topical twice daily for 14 days.
13649|NCT02635204|O1|Outcome|DFD-06 Cream|Participants received DFD-06 Cream applied topical twice daily for 14 days.
13650|NCT02635204|O2|Outcome|Vehicle Cream|Participants received Vehicle Cream applied topical twice daily for 14 days.
13651|NCT02635204|O1|Outcome|DFD-06 Cream|Participants received DFD-06 Cream applied topical twice daily for 14 days.
13652|NCT02635204|O2|Outcome|Vehicle Cream|Participants received Vehicle Cream applied topical twice daily for 14 days.
13653|NCT02635204|O1|Outcome|DFD-06 Cream|Participants received DFD-06 Cream applied topical twice daily for 14 days.
13654|NCT02635204|E2|Reported Event|Vehicle Cream|Vehicle Cream applied to subjects twice daily for 14 days.
13655|NCT02635204|E1|Reported Event|DFD-06 Cream|DFD-06 Cream applied to subjects twice daily for 14 days.
13656|NCT02634788|B5|Baseline|Total|Total of all reporting groups
13657|NCT02634788|B4|Baseline|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
13658|NCT02634788|B3|Baseline|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
13659|NCT02634788|B2|Baseline|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
13660|NCT02634788|B1|Baseline|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
13661|NCT02634788|P4|Participant Flow|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
13662|NCT02634788|P3|Participant Flow|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
13663|NCT02634788|P2|Participant Flow|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
13664|NCT02634788|P1|Participant Flow|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
13665|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
13666|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
13667|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
13668|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
13669|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
13670|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
13671|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
13672|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
13673|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
13674|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
13675|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
13676|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
13677|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
13678|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
20072|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
13680|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
13681|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
13682|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
13683|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
13684|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
13685|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
13686|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
13687|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
13688|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
13689|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
13690|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
13691|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
13692|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
13693|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
13694|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
13695|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
13696|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
13697|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
13698|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
13699|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
13700|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
13701|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
13702|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
13703|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
13704|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
13705|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
13706|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
13707|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
13708|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
13709|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
13710|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
13711|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
13712|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
13713|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
13714|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
13715|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
13716|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
13717|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
13718|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
13719|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
13720|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
13721|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
13722|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
13723|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
13724|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
13725|NCT02634788|E4|Reported Event|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
13726|NCT02634788|E3|Reported Event|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
14622|NCT02625259|E6|Reported Event|Part-3: Lansoprazole 30 mg|Lansoprazole 30 mg, capsule, orally, once daily from Day 10 to Day 14.
13727|NCT02634788|E2|Reported Event|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
13728|NCT02634788|E1|Reported Event|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
13729|NCT02634073|B1|Baseline|All Treatment Groups Combined|Sixteen participants were randomized to receive one of the following 4 treatment sequences : Treatment sequence 1 : ABCD; Treatment sequence 2: DABC; Trearment sequence 3: BCDA; Treatment sequence 4: CDAB; where A: Lamivudine 300 mg, B: Lamivudine 300 mg+ Sorbitol 3.2 g, C: Lamivudine 300 mg+ Sorbitol 10.2 g, D: Lamivudine 300 mg+ Sorbitol 13.4 g.
13730|NCT02634073|P4|Participant Flow|Treatment Sequence 4: DCAB|Participants were randomized to receive a single dose of each of the four treatments where A: Lamivudine 300 mg, B: Lamivudine 300 mg+ Sorbitol 3.2 g, C: Lamivudine 300 mg+ Sorbitol 10.2 g, D: Lamivudine 300 mg+ Sorbitol 13.4 g. All doses were administered after an overnight fast and there was >=7days washout between each period
13731|NCT02634073|P3|Participant Flow|Treatment Sequence 3: CBDA|Participants were randomized to receive a single dose of each of the four treatments where A: Lamivudine 300 mg, B: Lamivudine 300 mg+ Sorbitol 3.2 g, C: Lamivudine 300 mg+ Sorbitol 10.2 g, D: Lamivudine 300 mg+ Sorbitol 13.4 g. All doses were administered after an overnight fast and there was >=7days washout between each period
13732|NCT02634073|P2|Participant Flow|Treatment Sequence 2: BACD|Participants were randomized to receive a single dose of each of the four treatments where A: Lamivudine 300 mg, B: Lamivudine 300 mg+ Sorbitol 3.2 g, C: Lamivudine 300 mg+ Sorbitol 10.2 g, D: Lamivudine 300 mg+ Sorbitol 13.4 g. All doses were administered after an overnight fast and there was >=7days washout between each period
13733|NCT02634073|P1|Participant Flow|Treatment Sequence 1: ADBC|Participants were randomized to receive a single dose of each of the four treatments where A: Lamivudine 300 mg, B: Lamivudine 300 mg+ Sorbitol 3.2 g, C: Lamivudine 300 mg+ Sorbitol 10.2 g, D: Lamivudine 300 mg+ Sorbitol 13.4 g. All doses were administered after an overnight fast and there was >=7days washout between each period
13734|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13735|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13736|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13737|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13738|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13739|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13740|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13741|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13742|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13743|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13744|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13745|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13746|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13747|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
17737|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
13748|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13749|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13750|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13751|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13752|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13753|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13754|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13755|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13756|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13757|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13758|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13759|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13760|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13761|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13762|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13763|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13764|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13765|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13766|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13767|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
14408|NCT02628938|O1|Outcome|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days~Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
13768|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13769|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13770|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13771|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13772|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13773|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13774|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13775|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13776|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13777|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13778|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13779|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13780|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13781|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13782|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13783|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13784|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13785|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13786|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13787|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
14409|NCT02628938|O3|Outcome|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days~Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
13788|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13789|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13790|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13791|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13792|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13793|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13794|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13795|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13796|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13797|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13798|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13799|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13800|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13801|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13802|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13803|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13804|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13805|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13806|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13807|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
14410|NCT02628938|O2|Outcome|Miswak Sticks|"Sticks twice a day for 7 days~Miswak stick: Miswak stick twice a day for 7 days"
14623|NCT02625259|E5|Reported Event|Part-3: TAK-117 900 mg|TAK-117 3*300 mg, tablets (NTM), orally, once on Day 1.
13808|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13809|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13810|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13811|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13812|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13813|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13814|NCT02634073|E4|Reported Event|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13815|NCT02634073|E3|Reported Event|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13816|NCT02634073|E2|Reported Event|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13817|NCT02634073|E1|Reported Event|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
13818|NCT02633787|B1|Baseline|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093.
13819|NCT02633787|P1|Participant Flow|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 and were enrolled in MTA00093.
13820|NCT02633787|O1|Outcome|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093.
13821|NCT02633787|O1|Outcome|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093.
13822|NCT02633787|O1|Outcome|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093.
13823|NCT02633787|E1|Reported Event|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 and were enrolled in MTA00093.
13824|NCT02633215|B3|Baseline|Total|Total of all reporting groups
13825|NCT02633215|B2|Baseline|Sham Stimulation With Motor Training|"2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.~S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy"
13826|NCT02633215|B1|Baseline|Active Stimulation With Motor Training|"2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.~S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy"
13827|NCT02633215|P2|Participant Flow|Sham Stimulation With Motor Training|"2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.~S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy"
13828|NCT02633215|P1|Participant Flow|Active Stimulation With Motor Training|"2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.~S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy"
13849|NCT02632812|O1|Outcome|Rebamipide & Naproxen|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days~Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
20073|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
13829|NCT02633215|O2|Outcome|Sham Stimulation With Motor Training|"2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.~S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy"
13830|NCT02633215|O1|Outcome|Active Stimulation With Motor Training|"2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.~S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy"
13831|NCT02633215|O2|Outcome|Sham Stimulation With Motor Training|"2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.~S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy"
13832|NCT02633215|O1|Outcome|Active Stimulation With Motor Training|"2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.~S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy"
13833|NCT02633215|O2|Outcome|Sham Stimulation With Motor Training|"2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.~S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy"
13834|NCT02633215|O1|Outcome|Active Stimulation With Motor Training|"2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.~S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy"
13835|NCT02633215|E2|Reported Event|Sham Stimulation With Motor Training|"2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.~S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy"
13836|NCT02633215|E1|Reported Event|Active Stimulation With Motor Training|"2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.~S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy"
13837|NCT02632812|B3|Baseline|Total|Total of all reporting groups
13838|NCT02632812|B2|Baseline|Placebo|"Placebo effervescent granules (oral) Twice daily~Placebo effervescent granules~Naproxen tablet"
13839|NCT02632812|B1|Baseline|Rebamipide 200 mg|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg)~Rebamipide effervescent granules~Naproxen tablet"
13840|NCT02632812|P2|Participant Flow|Placebo|"Placebo effervescent granules (oral) Twice daily~Placebo effervescent granules~Naproxen tablet"
13841|NCT02632812|P1|Participant Flow|Rebamipide 200 mg|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg)~Rebamipide effervescent granules~Naproxen tablet"
13842|NCT02632812|O2|Outcome|Placebo & Naproxen|"Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days~Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
13843|NCT02632812|O1|Outcome|Rebamipide & Naproxen|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days~Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
13844|NCT02632812|O2|Outcome|Placebo & Naproxen|"Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days~Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
13845|NCT02632812|O1|Outcome|Rebamipide & Naproxen|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days~Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
13846|NCT02632812|O2|Outcome|Placebo & Naproxen|"Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days~Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
13847|NCT02632812|O1|Outcome|Rebamipide & Naproxen|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days~Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
13848|NCT02632812|O2|Outcome|Placebo & Naproxen|"Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days~Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
13850|NCT02632812|O2|Outcome|Placebo & Naproxen|"Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days~Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
13851|NCT02632812|O1|Outcome|Rebamipide & Naproxen|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days~Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
13852|NCT02632812|O2|Outcome|Placebo & Naproxen|"Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days~Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
13853|NCT02632812|O1|Outcome|Rebamipide & Naproxen|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days~Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
13854|NCT02632812|O2|Outcome|Placebo & Naproxen|"Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days~Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
13855|NCT02632812|O1|Outcome|Rebamipide & Naproxen|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days~Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
13856|NCT02632812|E2|Reported Event|Placebo|"Placebo effervescent granules (oral) Twice daily~Placebo effervescent granules~Naproxen tablet"
13857|NCT02632812|E1|Reported Event|Rebamipide 200 mg|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg)~Rebamipide effervescent granules~Naproxen tablet"
13858|NCT02632110|B6|Baseline|Total|Total of all reporting groups
13859|NCT02632110|B5|Baseline|VEH 60 Min 10 mW|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to VEH application.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13860|NCT02632110|B4|Baseline|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13861|NCT02632110|B3|Baseline|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13862|NCT02632110|B2|Baseline|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13863|NCT02632110|B1|Baseline|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13864|NCT02632110|P10|Participant Flow|VEH 60 Min 10 mW|"Vehicle (VEH) PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to VEH application.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13865|NCT02632110|P9|Participant Flow|MN + VEH 60 Min 10 mW|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application"
13866|NCT02632110|P8|Participant Flow|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13867|NCT02632110|P7|Participant Flow|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13868|NCT02632110|P6|Participant Flow|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13869|NCT02632110|P5|Participant Flow|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14352|NCT02630992|O1|Outcome|Amoxicillin-clavulanate Potassium|amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)
13870|NCT02632110|P4|Participant Flow|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13871|NCT02632110|P3|Participant Flow|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13872|NCT02632110|P2|Participant Flow|ALA 25 Min 10 mW|"Aminolevulinic acid photodynamic therapy (ALA-PDT), 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle (MN): one actinic keratosis (AK) Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.~Investigational Blue Light (IBL) 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13873|NCT02632110|P1|Participant Flow|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application"
13874|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13875|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13876|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13877|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13878|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13879|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13880|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13881|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13882|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13883|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13884|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13885|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13886|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13887|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13888|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
15700|NCT02609113|O1|Outcome|Strong Magnetic Wristband|"Magnetic wristband of 1,795 Gauss strength~Strong Magnetic Wristband"
13889|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13890|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13891|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13892|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13893|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13894|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13895|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13896|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13897|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13898|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13899|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13900|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13901|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13902|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13903|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13904|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13905|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13906|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13907|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13908|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13909|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13910|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13911|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13912|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13913|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13914|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13915|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13916|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13917|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13918|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13919|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13920|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13921|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13922|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13923|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13924|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13925|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13926|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13927|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13928|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13929|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13930|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13931|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13932|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13933|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13934|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13935|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13936|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13937|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13938|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13939|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13940|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13941|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13942|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13943|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13944|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13945|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13946|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13947|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13948|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13949|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13950|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13951|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13952|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13953|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13954|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13955|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13956|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13957|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13958|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13959|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13960|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13961|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13962|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13963|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13964|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13965|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13966|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13967|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13968|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13969|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13970|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13971|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13972|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13973|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13974|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13975|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13976|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13977|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13978|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13979|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13980|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13981|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13982|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13983|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13984|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13985|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13986|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13987|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13988|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13989|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13990|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13991|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13992|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13993|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13994|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13995|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
13996|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13997|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
13998|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
13999|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14000|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14001|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14002|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14003|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14004|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14005|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14006|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14007|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14008|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14009|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14010|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14011|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14012|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14013|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14014|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14015|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14016|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14017|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14018|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14019|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14020|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14021|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14022|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14023|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14024|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14025|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14026|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14027|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14028|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14029|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14030|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14031|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14032|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14033|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14034|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14035|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14036|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14037|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14038|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14039|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14040|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14041|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14042|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14043|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14044|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14045|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14046|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14047|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14048|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14049|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14050|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14051|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14052|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14053|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14054|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14055|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14056|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14057|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14058|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14059|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14060|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14061|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14062|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14063|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14064|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14065|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14066|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14067|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14068|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14069|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14070|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14071|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14072|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14073|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14074|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14075|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14076|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14077|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14078|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14079|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14080|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14081|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14082|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14083|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14084|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14085|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14086|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14087|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14088|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14089|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14090|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14091|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14092|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14093|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14094|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14095|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14096|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14097|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14098|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14099|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14100|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14101|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14102|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14103|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14104|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14105|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14106|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14107|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14108|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14109|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14110|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14111|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14112|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14113|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14114|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14115|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14116|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14117|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14118|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14119|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14120|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14121|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14122|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14123|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14124|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14125|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14126|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14127|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14128|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14129|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14130|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14131|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14132|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14133|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14134|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14135|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14136|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14137|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14138|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14139|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14140|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14141|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14142|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14143|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14144|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14145|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14146|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14147|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14148|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14149|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14150|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14151|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14152|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14153|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14154|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14155|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14156|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14157|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14158|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14159|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14160|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14161|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14162|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14163|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14164|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14165|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14166|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14167|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14168|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14169|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14170|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14171|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14172|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14173|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14174|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14175|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14176|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14177|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14178|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14179|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14180|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14181|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14182|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14183|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14184|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14185|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14186|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14187|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14188|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14189|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14190|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14191|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14192|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14193|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14194|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14195|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14196|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14197|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14198|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14199|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14200|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14201|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14202|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14203|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14204|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14205|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14206|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14207|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14208|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14209|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14210|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14211|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14212|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14213|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14214|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14215|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14216|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14217|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14218|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14219|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14220|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14221|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14222|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14223|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14224|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14225|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14226|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14227|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14228|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14229|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14230|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14231|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14232|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14233|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14234|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14235|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14236|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14237|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14238|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14239|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14240|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14241|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14242|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14243|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14244|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14245|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14246|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14247|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14248|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14249|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14250|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14251|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14252|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14253|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14254|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14255|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14256|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14257|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14258|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14259|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14260|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14261|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14262|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14263|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14264|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14265|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14266|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14267|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14268|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14269|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14270|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14271|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14272|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14273|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14274|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14275|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14276|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14277|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14278|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14279|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14280|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14281|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14282|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14283|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14284|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14285|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14286|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14287|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14288|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14289|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14290|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14291|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14292|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14293|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14294|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14295|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14296|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14297|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14298|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14299|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14300|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14301|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14302|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14303|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14304|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14305|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14306|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14307|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14308|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14309|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14310|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14311|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14312|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14313|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14314|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14315|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14316|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14317|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14318|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14319|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14320|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14321|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14322|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14323|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14324|NCT02632110|O10|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14325|NCT02632110|O9|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14326|NCT02632110|O8|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14327|NCT02632110|O7|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14328|NCT02632110|O6|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14329|NCT02632110|O5|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14330|NCT02632110|O4|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14331|NCT02632110|O3|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14332|NCT02632110|O2|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14333|NCT02632110|O1|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
14334|NCT02632110|E5|Reported Event|VEH 60 Min 10 mW|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to VEH application.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14335|NCT02632110|E4|Reported Event|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14336|NCT02632110|E3|Reported Event|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14337|NCT02632110|E2|Reported Event|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
14338|NCT02632110|E1|Reported Event|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
14339|NCT02631057|B3|Baseline|Total|Total of all reporting groups
14340|NCT02631057|B2|Baseline|Warfarin|Dose-adjusted Warfarin for several days to reach an effective International Normalized Ratio (INR) for ischemic stroke prevention due to NVAF.
14341|NCT02631057|B1|Baseline|Dabigatran Etexilate [Prazaxa®]|The patients were administered Dabigatran Etexilate 75 mg*2 mg capsules twice daily or 110 mg capsules twice daily orally for Non-Valvular Atrial Fibrillation (NVAF).
14342|NCT02631057|P2|Participant Flow|Warfarin|Dose-adjusted Warfarin for several days to reach an effective International Normalized Ratio (INR) for ischemic stroke prevention due to NVAF.
14343|NCT02631057|P1|Participant Flow|Dabigatran Etexilate [Prazaxa®]|The patients were administered Dabigatran Etexilate 75 mg*2 mg capsules twice daily or 110 mg capsules twice daily orally for Non-Valvular Atrial Fibrillation (NVAF).
14344|NCT02631057|O2|Outcome|Warfarin|Dose-adjusted Warfarin for several days to reach an effective International Normalized Ratio (INR) for ischemic stroke prevention due to NVAF.
14345|NCT02631057|O1|Outcome|Dabigatran Etexilate [Prazaxa®]|The patients were administered Dabigatran Etexilate 75 mg*2 mg capsules twice daily or 110 mg capsules twice daily orally for Non-Valvular Atrial Fibrillation (NVAF).
14346|NCT02631057|E2|Reported Event|Warfarin|Dose-adjusted Warfarin for several days to reach an effective International Normalized Ratio (INR) for ischemic stroke prevention due to NVAF.
14347|NCT02631057|E1|Reported Event|Dabigatran Etexilate [Prazaxa®]|The patients were administered Dabigatran Etexilate 75 mg*2 mg capsules twice daily or 110 mg capsules twice daily orally for Non-Valvular Atrial Fibrillation (NVAF).
14348|NCT02630992|B1|Baseline|Amoxicillin-clavulanate Potassium|amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)
14349|NCT02630992|P1|Participant Flow|Amoxicillin-clavulanate Potassium|amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)
14350|NCT02630992|O1|Outcome|Amoxicillin-clavulanate Potassium|amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)
14351|NCT02630992|O1|Outcome|Amoxicillin-clavulanate Potassium|amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)
14625|NCT02625259|E3|Reported Event|Part-2: TAK-117 600 mg Fasted|TAK-117 2*300 mg, tablets (NTM), orally, once in a fasted state on Day 1 or 15 of intervention period.
14353|NCT02630992|O1|Outcome|Amoxicillin-clavulanate Potassium|amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)
14354|NCT02630992|O1|Outcome|Amoxicillin-clavulanate Potassium|amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)
14355|NCT02630992|O1|Outcome|Amoxicillin-clavulanate Potassium|amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)
14356|NCT02630992|O1|Outcome|Amoxicillin-clavulanate Potassium|amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)
14357|NCT02630992|O1|Outcome|Amoxicillin-clavulanate Potassium|amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)
14358|NCT02630992|O1|Outcome|Amoxicillin-clavulanate Potassium|amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)
14359|NCT02630992|O1|Outcome|Amoxicillin-clavulanate Potassium|amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)
14360|NCT02630992|O1|Outcome|Amoxicillin-clavulanate Potassium|amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)
14361|NCT02630992|O1|Outcome|Amoxicillin-clavulanate Potassium|amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)
14362|NCT02630992|O1|Outcome|Amoxicillin-clavulanate Potassium|amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)
14363|NCT02630992|O1|Outcome|Amoxicillin-clavulanate Potassium|amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)
14364|NCT02630992|E1|Reported Event|Amoxicillin-clavulanate Potassium|amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg in two divided doses for 10 days; oral, liquid (formulation 2)
14365|NCT02630563|B1|Baseline|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
14366|NCT02630563|P1|Participant Flow|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
14367|NCT02630563|O1|Outcome|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16.
14368|NCT02630563|O1|Outcome|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16.
14369|NCT02630563|O1|Outcome|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
14370|NCT02630563|O1|Outcome|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
14371|NCT02630563|O1|Outcome|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
14372|NCT02630563|O1|Outcome|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
14373|NCT02630563|E1|Reported Event|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
14374|NCT02629354|B3|Baseline|Total|Total of all reporting groups
14626|NCT02625259|E2|Reported Event|Part-1: TAK-117 900 mg Tablets|TAK-117 3*300 mg, tablets (NTM), orally, once on Day 1 or 15 of intervention period.
14375|NCT02629354|B2|Baseline|Test - Ref|Subjects received the test product (Test) which was a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine in a film coated tablet as a FDC under fed conditions. After a washout period of at least 6 calendar days, the subjects received the reference product (Ref), which was a single oral dose (1 film-coated tablet) of 400 milligram (mg) ibuprofen (equivalent to 684 mg ibuprofen lysinate, trade name: Dolormin® Extra), under fed conditions. Finally the subjects had a follow-up phase of 72 hours.
14376|NCT02629354|B1|Baseline|Ref - Test|Subjects received the reference product (Ref) which was a single oral dose (1 film-coated tablet) of 400 milligram (mg) ibuprofen (equivalent to 684 mg ibuprofen lysinate, trade name: Dolormin® Extra) under fed conditions. After a washout period of at least 6 calendar days, the subjects received the test product (Test), which was a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine in a film coated tablet as a fixed dose combination (FDC), under fed conditions. Finally the subjects had a follow-up phase of 72 hours.
14377|NCT02629354|P2|Participant Flow|Test - Ref|Subjects received the test product (Test) which was a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine in a film coated tablet as a FDC under fed conditions. After a washout period of at least 6 calendar days, the subjects received the reference product (Ref), which was a single oral dose (1 film-coated tablet) of 400 milligram (mg) ibuprofen (equivalent to 684 mg ibuprofen lysinate, trade name: Dolormin® Extra), under fed conditions. Finally the subjects had a follow-up phase of 72 hours.
14378|NCT02629354|P1|Participant Flow|Ref - Test|Subjects received the reference product (Ref) which was a single oral dose (1 film-coated tablet) of 400 milligram (mg) ibuprofen (equivalent to 684 mg ibuprofen lysinate, trade name: Dolormin® Extra) under fed conditions. After a washout period of at least 6 calendar days, the subjects received the test product (Test), which was a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine in a film coated tablet as a fixed dose combination (FDC), under fed conditions. Finally the subjects had a follow-up phase of 72 hours.
14379|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
14380|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
14381|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
14382|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
14383|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
14384|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
14385|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
14386|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
14387|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
14388|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
14389|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
14390|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
14391|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
14392|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
14393|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
14394|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
14395|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
14396|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
14397|NCT02629354|E2|Reported Event|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
14398|NCT02629354|E1|Reported Event|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
14399|NCT02628938|B4|Baseline|Total|Total of all reporting groups
14400|NCT02628938|B3|Baseline|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days~Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
14401|NCT02628938|B2|Baseline|Miswak Sticks|"Sticks twice a day for 7 days~Miswak stick: Miswak stick twice a day for 7 days"
14402|NCT02628938|B1|Baseline|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days~Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
14403|NCT02628938|P3|Participant Flow|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days~Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
14404|NCT02628938|P2|Participant Flow|Miswak Sticks|"Sticks twice a day for 7 days~Miswak stick: Miswak stick twice a day for 7 days"
14405|NCT02628938|P1|Participant Flow|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days~Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
14406|NCT02628938|O3|Outcome|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days~Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
14407|NCT02628938|O2|Outcome|Miswak Sticks|"Sticks twice a day for 7 days~Miswak stick: Miswak stick twice a day for 7 days"
15701|NCT02609113|O2|Outcome|Weaker Magnetic Wristband|"Magnetic wristband of 5 Gauss strength.~Weaker Magnetic Wristband"
14411|NCT02628938|O1|Outcome|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days~Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
14412|NCT02628938|O3|Outcome|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days~Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
14413|NCT02628938|O2|Outcome|Miswak Sticks|"Sticks twice a day for 7 days~Miswak stick: Miswak stick twice a day for 7 days"
14414|NCT02628938|O1|Outcome|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days~Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
14415|NCT02628938|E3|Reported Event|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days~Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
14416|NCT02628938|E2|Reported Event|Miswak Sticks|"Sticks twice a day for 7 days~Miswak stick: Miswak stick twice a day for 7 days"
14417|NCT02628938|E1|Reported Event|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days~Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
14418|NCT02628418|B3|Baseline|Total|Total of all reporting groups
14419|NCT02628418|B2|Baseline|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation~Specific Hand Rehabilitation (SHR) performed by physiotherapist~General Rehabilitation: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
14420|NCT02628418|B1|Baseline|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device~GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.~SHR by Gloreha device: Each training session consisted of six parts:~A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min);~7 min of a number sequence (counting from one to five);~A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min)~A sequence of wave-like finger movements (7 min)~A sequence of fist opening/closing (7 min)~A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
14421|NCT02628418|P2|Participant Flow|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation performed by physiotherapist (SHR) GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
14422|NCT02628418|P1|Participant Flow|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
14423|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation (SHR) performed by physiotherapist. GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
14424|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
14425|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation (SHR) performed by physiotherapist. GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
14586|NCT02625259|B4|Baseline|Part-2: TAK-117 600 mg Fed + TAK-117 600 mg Fasted|TAK-117 2*300 mg, tablets (NTM), orally, once with a standard high-fat breakfast on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 2*300 mg, tablets (NTM), orally, in the fasted state, once on Day 15 (second intervention).
14426|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
14427|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation (SHR) performed by physiotherapist. GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
14428|NCT02628418|O1|Outcome|Gloreha Group|"TThe patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
14429|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation (SHR) performed by physiotherapist GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
14430|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
14431|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
14432|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation (SHR) performed by physiotherapist GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR on performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
14433|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
14434|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation~Specific hand rehabilitation performed by physiotherapist~General Rehabilitation: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.~Specific hand rehabilitation performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
14446|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
17738|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
14435|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
14436|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation performed by physiotherapist (SHR) GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
14437|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min);~7 min of a number sequence (counting from one to five);~A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min)~A sequence of wave-like finger movements (7 min)~A sequence of fist opening/closing (7 min)~A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
14438|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation performed by physiotherapist (SHR) GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
14439|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
14440|NCT02628418|E2|Reported Event|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation~Specific hand rehabilitation performed by physiotherapist~General Rehabilitation: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.~Specific hand rehabilitation performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
14441|NCT02628418|E1|Reported Event|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device~GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.~SHR by Gloreha device: Each training session consisted of six parts:~A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min);~7 min of a number sequence (counting from one to five);~A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min)~A sequence of wave-like finger movements (7 min)~A sequence of fist opening/closing (7 min)~A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
14442|NCT02628236|B1|Baseline|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14443|NCT02628236|P1|Participant Flow|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14444|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14445|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14581|NCT02625298|O1|Outcome|ProRoot MTA|"Traumatized permanent teeth obturated with ProRoot MTA after root canal treatment~ProRoot MTA: Apical thirds of the root canals obturated with ProRoot MTA (Dentsply Tulsa Dental Specialties, Tulsa, OK USA)."
20074|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
14447|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14448|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14449|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14450|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14451|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14452|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14453|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14454|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14455|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14456|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14457|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14458|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14459|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14460|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14461|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14462|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14463|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14464|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14465|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14466|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14467|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14468|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14469|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14470|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14471|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14472|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14473|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14474|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14475|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14476|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14477|NCT02628236|O1|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14478|NCT02628236|E1|Reported Event|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
14479|NCT02628106|B1|Baseline|Lipo-prostaglandin E1|"all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days.~Lipo-PGE1: all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days"
14480|NCT02628106|P1|Participant Flow|Diabetic Nephropathy,Chronic Kidney Disease|all patients receivedlipo-prostaglandin E1,10ug per day, iv for 14 consecutive days.renal hypoxia in patients with diabetic nephropathy was improves evaluate via blood oxygenation level dependent magnetic resonance imaging
14481|NCT02628106|O1|Outcome|Diabetic Nephropathy,Chronic Kidney Disease|all patients received lipo-prostaglandin E1,10ug per day, iv for 14 consecutive days.renal hypoxia in patients with diabetic nephropathy was improves evaluate via blood oxygenation level dependent magnetic resonance imaging
14482|NCT02628106|E1|Reported Event|Diabetic Nephropathy,Chronic Kidney Disease|all patients received lipo-prostaglandin E1,10ug per day, iv for 14 consecutive days.renal hypoxia in patients with diabetic nephropathy was improves evaluate via blood oxygenation level dependent magnetic resonance imaging
14483|NCT02627794|B1|Baseline|Restora™ Steroid Eluting & Silastic Silicone Spacer|"This arm receives both Restora™ Steroid eluting & Silastic Silicone spacers.~The Restora™ Steroid eluting and Silastic Silicone Spacers will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery."
14484|NCT02627794|P1|Participant Flow|Restora™ Steroid Eluting & Silastic Silicone Spacers|"This study arm receives both the experimental treatment, a Restora™ Steroid eluting spacer and Silastic Silicone spacer.~Both spacers will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery."
14485|NCT02627794|O1|Outcome|Restora™ Steroid Eluting & Silastic Silicone Spacer|"This arm receives both Restora™ Steroid eluting & Silastic Silicone spacers.~The Restora™ Steroid eluting and Silastic Silicone Spacers will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery."
14486|NCT02627794|O1|Outcome|Restora™ Steroid Eluting & Silastic Silicone Spacer|"This arm receives both Restora™ Steroid eluting & Silastic Silicone spacers.~The Restora™ Steroid eluting and Silastic Silicone Spacers will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery."
14582|NCT02625298|E2|Reported Event|MTA+ Cercamed|"Traumatized permanent teeth obturated with MTA+ Cerkamed after root canal treatment~MTA+ Cerkamed: Apical thirds of the root canals obturated with MTA + (Cerkamed, Stalowa Wola, Poland)."
20075|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
14487|NCT02627794|O1|Outcome|Restora™ Steroid Eluting & Silastic Silicone Spacer|"This arm receives both Restora™ Steroid eluting & Silastic Silicone spacers.~The Restora™ Steroid eluting and Silastic Silicone Spacers will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery."
14488|NCT02627794|O1|Outcome|Restora™ Steroid Eluting & Silastic Silicone Spacer|"This arm receives both Restora™ Steroid eluting & Silastic Silicone spacers.~The Restora™ Steroid eluting and Silastic Silicone Spacers will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery."
14489|NCT02627794|O1|Outcome|Restora™ Steroid Eluting & Silastic Silicone Spacer|"This arm receives both Restora™ Steroid eluting & Silastic Silicone spacers.~The Restora™ Steroid eluting and Silastic Silicone Spacers will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery."
14490|NCT02627794|O1|Outcome|Restora™ Steroid Eluting & Silastic Silicone Spacer|"This arm receives both Restora™ Steroid eluting & Silastic Silicone spacers.~The Restora™ Steroid eluting and Silastic Silicone Spacers will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery."
14491|NCT02627794|O1|Outcome|Restora™ Steroid Eluting & Silastic Silicone Spacer|"This arm receives both Restora™ Steroid eluting & Silastic Silicone spacers.~The Restora™ Steroid eluting and Silastic Silicone Spacers will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery."
14492|NCT02627794|O2|Outcome|Restora™ Steroid Eluting Spacer|"This study arm receives the experimental treatment, a Restora™ Steroid eluting spacer.~Restora™ Steroid eluting spacer: The Restora™ Steroid eluting spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery."
14493|NCT02627794|O1|Outcome|Silastic Silicone Spacer|"Silastic Silicone spacers are actively being used as the standard of care.~Silastic Silicone Spacer: The Silastic Silicone Spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery."
14494|NCT02627794|E2|Reported Event|Restora™ Steroid Eluting Spacer|"This study arm receives the experimental treatment, a Restora™ Steroid eluting spacer.~Restora™ Steroid eluting spacer: The Restora™ Steroid eluting spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery."
14495|NCT02627794|E1|Reported Event|Silastic Silicone Spacer|"Silastic Silicone spacers are actively being used as the standard of care.~Silastic Silicone Spacer: The Silastic Silicone Spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery."
14496|NCT02627144|B1|Baseline|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
14497|NCT02627144|P1|Participant Flow|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
14498|NCT02627144|O1|Outcome|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
14499|NCT02627144|O1|Outcome|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
14500|NCT02627144|O1|Outcome|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
14501|NCT02627144|O1|Outcome|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
14502|NCT02627144|O1|Outcome|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
14583|NCT02625298|E1|Reported Event|ProRoot MTA|"Traumatized permanent teeth obturated with ProRoot MTA after root canal treatment~ProRoot MTA: Apical thirds of the root canals obturated with ProRoot MTA (Dentsply Tulsa Dental Specialties, Tulsa, OK USA)."
14584|NCT02625259|B6|Baseline|Total|Total of all reporting groups
14503|NCT02627144|E1|Reported Event|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
14504|NCT02627001|B3|Baseline|Total|Total of all reporting groups
14505|NCT02627001|B2|Baseline|Standard Bag Valve Mask First, Then Numask Intraoral Mask|"A United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. The Medic then performs the same procedures using a Nu-Mask Intraoral Airway Device.~Bag Valve Mask: Conventional bag valve mask"
14506|NCT02627001|B1|Baseline|NuMask Intraoral Mask First, Then Standard Bag Valve Mask|"A United States Army Combat Medic uses a single hand technique to hold a Nu-Mask Intraoral Airway Device on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. The Medic then performs the same procedures using a standard bag valve mask.~NuMask Intraoral Airway Device: NuMask Intraoral Airway Device"
14507|NCT02627001|P2|Participant Flow|Standard Bag Valve Mask First, Then Numask Intraoral Mask|"A United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. After a 5 minute rest period, the subject performs the same procedures using an intraoral mask.~Bag Valve Mask: Conventional bag valve mask"
14508|NCT02627001|P1|Participant Flow|NuMask Intraoral Mask First, Then Standard Bag Valve Mask|"A United States Army Combat Medic uses a single hand technique to hold a Nu-Mask Intraoral Airway Device on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. After a 5 minute rest period, the subject performs the same procedures using a conventional cuffed face mask.~NuMask Intraoral Airway Device: NuMask Intraoral Airway Device"
14509|NCT02627001|O2|Outcome|Bag Valve Mask|"A United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each.~Bag Valve Mask: Conventional bag valve mask"
14510|NCT02627001|O1|Outcome|NuMask Intraoral Airway Device|"A United States Army Combat Medic uses a single hand technique to hold a Nu-Mask Intraoral Airway Device on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each.~NuMask Intraoral Airway Device: NuMask Intraoral Airway Device"
14511|NCT02627001|E2|Reported Event|Bag Valve Mask|"A United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each.~Bag Valve Mask: Conventional bag valve mask"
14512|NCT02627001|E1|Reported Event|NuMask Intraoral Airway Device|"A United States Army Combat Medic uses a single hand technique to hold a Nu-Mask Intraoral Airway Device on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each.~NuMask Intraoral Airway Device: NuMask Intraoral Airway Device"
14513|NCT02626910|B5|Baseline|Total|Total of all reporting groups
14514|NCT02626910|B4|Baseline|Urban Group|People with and without disabilities recruited from an Urban setting.
14515|NCT02626910|B3|Baseline|Second Life: Clinicians|Clinicians recruited from the virtual world, Second life.
14516|NCT02626910|B2|Baseline|Second Life: People Without Disabilities|People without disabilities recruited from the virtual world, Second life.
14517|NCT02626910|B1|Baseline|Second Life: People With Disabilities|People with disabilities recruited from the virtual world, Second life.
14518|NCT02626910|P4|Participant Flow|Urban Group|People with and without disabilities recruited from an Urban setting.
14519|NCT02626910|P3|Participant Flow|Second Life: Clinicians|Clinicians recruited from the virtual world, Second life.
14520|NCT02626910|P2|Participant Flow|Second Life: People Without Disabilities|People without disabilities recruited from the virtual world, Second life.
14521|NCT02626910|P1|Participant Flow|Second Life: People With Disabilities|People with disabilities recruited from the virtual world, Second life.
14522|NCT02626910|O4|Outcome|Urban|People with and without disabilities recruited from an Urban community
14523|NCT02626910|O3|Outcome|Second Life: Clinicians|Clinicians recruited from the virtual world Second life
14524|NCT02626910|O2|Outcome|Second Life: People Without Disabilities|People without disabilities recruited fro the virtual world Second Life
14525|NCT02626910|O1|Outcome|Second Life: People With Disabilities|People with disabilities recruited from the virtual world, Second life.
14526|NCT02626910|E4|Reported Event|Urban|People with and without disabilities recruited from an Urban community.
14527|NCT02626910|E3|Reported Event|Second Life: Clinicians|Clinicians recruited from the virtual world, Second life.
14528|NCT02626910|E2|Reported Event|Second Life:People Without Disabilities|People without disabilities recruited from the virtual world, Second life.
14529|NCT02626910|E1|Reported Event|Second Life: People With Disabilities|People with disabilities recruited from the virtual world, Second life.
14530|NCT02626611|B4|Baseline|Total|Total of all reporting groups
14531|NCT02626611|B3|Baseline|High Dose Food|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.~Omalizumab: Omalizumab is administered per product insert from weeks 0 - 16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized."
14619|NCT02625259|O2|Outcome|Part-1: TAK-117 900 mg Tablets (3*300 mg Tablets)|TAK-117 3*300 mg, tablets (NTM), orally, once on Day 1 or 15 of intervention period.
17739|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
14532|NCT02626611|B2|Baseline|Low Dose Food|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.~Omalizumab: Omalizumab is administered per product insert from weeks 0 -16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized."
14533|NCT02626611|B1|Baseline|Placebo|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.~Omalizumab: Omalizumab is administered per product insert from weeks 0 -16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized."
14534|NCT02626611|P3|Participant Flow|High Dose Food|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.~Omalizumab: Omalizumab is administered per product insert from weeks 0 - 16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized."
14535|NCT02626611|P2|Participant Flow|Low Dose Food|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.~Omalizumab: Omalizumab is administered per product insert from weeks 0 -16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized."
14536|NCT02626611|P1|Participant Flow|Placebo|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.~Omalizumab: Omalizumab is administered per product insert from weeks 0 -16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized."
14537|NCT02626611|O3|Outcome|High Dose Food|Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food.
14538|NCT02626611|O2|Outcome|Low Dose Food|Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food.
14539|NCT02626611|O1|Outcome|Placebo|Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food.
14540|NCT02626611|O3|Outcome|High Dose Food|Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food.
14541|NCT02626611|O2|Outcome|Low Dose Food|Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food.
14542|NCT02626611|O1|Outcome|Placebo|Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food.
14543|NCT02626611|O3|Outcome|High Dose Food|Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food.
14544|NCT02626611|O2|Outcome|Low Dose Food|Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food.
14545|NCT02626611|O1|Outcome|Placebo|Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food.
14585|NCT02625259|B5|Baseline|Part-3: TAK-117 900 mg + Lansoprazole 30 mg|TAK-117 3*300 mg, tablets (NTM), orally, once on Day 1, followed by lansoprazole 30 mg, capsule, orally, once daily from Day 10 to Day 15 along with TAK-117 3*300 mg, tablets (NTM), orally, once on Day 15 approximately 1 hour (hr) after the last dose of lansoprazole 30 mg.
14620|NCT02625259|O1|Outcome|Part-1: TAK-117 900 mg Capsules (9*100 mg Capsules)|TAK-117 9*100 mg, capsules (CTM), orally, once on Day 1 or 15 of intervention period.
14546|NCT02626611|O3|Outcome|High Dose Food|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks.~Omalizumab: Omalizumab is an anti-Immunoglobulin E antibody injection and will be administered per product insert from weeks 0 through 16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 m"
14547|NCT02626611|O2|Outcome|Low Dose Food|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks.~Omalizumab: Omalizumab is an anti-Immunoglobulin E antibody injection and will be administered per product insert from weeks 0 through 16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 m"
14548|NCT02626611|O1|Outcome|Placebo|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks.~Omalizumab: Omalizumab is an anti-Immunoglobulin E antibody injection and will be administered per product insert from weeks 0 through 16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 m"
14549|NCT02626611|O3|Outcome|High Dose Food|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.~Omalizumab: Omalizumab is administered per product insert from weeks 0 - 16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized."
14550|NCT02626611|O2|Outcome|Low Dose Food|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.~Omalizumab: Omalizumab is administered per product insert from weeks 0 -16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized."
14551|NCT02626611|O1|Outcome|Placebo|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.~Omalizumab: Omalizumab is administered per product insert from weeks 0 -16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized."
14552|NCT02626611|E4|Reported Event|High Dose Food|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.~Omalizumab: Omalizumab is administered per product insert from weeks 0 - 16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized."
14553|NCT02626611|E3|Reported Event|Low Dose Food|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.~Omalizumab: Omalizumab is administered per product insert from weeks 0 -16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized."
14624|NCT02625259|E4|Reported Event|Part-2: TAK-117 600 mg Fed|TAK-117 2*300 mg, tablets (NTM), orally, with a standard high-fat breakfast, once on Day 1 or 15 of intervention period.
14554|NCT02626611|E2|Reported Event|Placebo|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.~Omalizumab: Omalizumab is administered per product insert from weeks 0 -16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized."
14555|NCT02626611|E1|Reported Event|All Participants Prior to Active Phase|Only Xolair administered before active phase began.
14556|NCT02625844|B1|Baseline|Erythropoiesis Stimulating Agents (ESAs)|Healthcare personnel performing anemia care for patients.
14557|NCT02625844|P1|Participant Flow|Erythropoiesis Stimulating Agents (ESAs)|Healthcare personnel performing anemia care for patients.
14558|NCT02625844|O1|Outcome|Erythropoiesis Stimulating Agents (ESAs)|Healthcare personnel performing anemia care for patients.
14559|NCT02625844|E1|Reported Event|Erythropoiesis Stimulating Agents (ESAs)|Healthcare personnel performing anemia care for patients.
14560|NCT02625402|B3|Baseline|Total|Total of all reporting groups
14561|NCT02625402|B2|Baseline|Video Decision Aid|"Group receiving long video decision aids. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog~Long video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis"
14562|NCT02625402|B1|Baseline|Interactive Decision Aid|"Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise~Brief interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis"
14563|NCT02625402|P2|Participant Flow|Video Decision Aid|"Group receiving long video decision aids. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog~Long video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis"
14564|NCT02625402|P1|Participant Flow|Interactive Decision Aid|"Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise~Brief interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis"
14565|NCT02625402|O2|Outcome|Video Decision Aid|"Group receiving long video decision aids. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog~Long video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis"
14566|NCT02625402|O1|Outcome|Interactive Decision Aid|"Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise~Brief interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis"
14567|NCT02625402|O2|Outcome|Video Decision Aid|"Group receiving long video decision aids. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog~Long video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis"
14568|NCT02625402|O1|Outcome|Interactive Decision Aid|"Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise~Brief interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis"
14569|NCT02625402|O2|Outcome|Video Decision Aid|"Group receiving long video decision aids. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog~Long video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis"
14570|NCT02625402|O1|Outcome|Interactive Decision Aid|"Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise~Brief interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis"
14571|NCT02625402|E2|Reported Event|Video Decision Aid|"Group receiving long video decision aids. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog~Long video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis"
14572|NCT02625402|E1|Reported Event|Interactive Decision Aid|"Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise~Brief interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis"
14573|NCT02625298|B3|Baseline|Total|Total of all reporting groups
14574|NCT02625298|B2|Baseline|MTA+ Cercamed|"Traumatized permanent teeth obturated with MTA+ Cerkamed after root canal treatment~MTA+ Cerkamed: Apical thirds of the root canals obturated with MTA + (Cerkamed, Stalowa Wola, Poland)."
14575|NCT02625298|B1|Baseline|ProRoot MTA|"Traumatized permanent teeth obturated with ProRoot MTA after root canal treatment~ProRoot MTA: Apical thirds of the root canals obturated with ProRoot MTA (Dentsply Tulsa Dental Specialties, Tulsa, OK USA)."
14576|NCT02625298|P2|Participant Flow|MTA+ Cercamed|"Traumatized permanent teeth obturated with MTA+ Cerkamed after root canal treatment~MTA+ Cerkamed: Apical thirds of the root canals obturated with MTA + (Cerkamed, Stalowa Wola, Poland)."
14577|NCT02625298|P1|Participant Flow|ProRoot MTA|"Traumatized permanent teeth obturated with ProRoot MTA after root canal treatment~ProRoot MTA: Apical thirds of the root canals obturated with ProRoot MTA (Dentsply Tulsa Dental Specialties, Tulsa, OK USA)."
14578|NCT02625298|O2|Outcome|MTA+ Cercamed|Traumatized permanent teeth obturated with MTA+ Cerkamed after root canal treatment
14579|NCT02625298|O1|Outcome|ProRoot MTA|Traumatized permanent teeth obturated with ProRoot MTA after root canal treatment
14580|NCT02625298|O2|Outcome|MTA+ Cercamed|"Traumatized permanent teeth obturated with MTA+ Cerkamed after root canal treatment~MTA+ Cerkamed: Apical thirds of the root canals obturated with MTA + (Cerkamed, Stalowa Wola, Poland)."
14621|NCT02625259|E7|Reported Event|Part 3: Lansoprazole 30 mg + TAK-117 900 mg|Lansoprazole 30 mg, capsule, orally, once daily on Day 15 along with TAK-117 3*300 mg, tablets (NTM), orally, once on Day 15.
14587|NCT02625259|B3|Baseline|Part-2: TAK-117 600 mg Fasted + TAK-117 600 mg Fed|TAK-117 2*300 mg, tablets (NTM), orally, once in the fasted state on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 2*300 mg, tablets (NTM), orally, with a standard high-fat breakfast, once on Day 15 (second intervention).
14588|NCT02625259|B2|Baseline|Part-1: TAK-117 900 mg Tablets + TAK-117 900 mg Capsules|TAK-117 3*300 mg, tablets (NTM), orally, once on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 9*100 mg, capsules (CTM), orally, once on Day 15 (second intervention).
14589|NCT02625259|B1|Baseline|Part-1: TAK-117 900 mg Capsules + TAK-117 900 mg Tablets|TAK-117 9*100 mg, capsules (current clinical trial material [CTM]), orally, once on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 3*300 mg, tablets (new clinical trial material [NTM]), orally, once on Day 15 (second intervention).
14590|NCT02625259|P5|Participant Flow|Part-3: TAK-117 900 mg + Lansoprazole 30 mg|TAK-117 3*300 mg, tablets (NTM), orally, once on Day 1, followed by lansoprazole 30 mg, capsule, orally, once daily from Day 10 to Day 15 along with TAK-117 3*300 mg, tablets (NTM), orally, once on Day 15 approximately 1 hour (hr) after the last dose of lansoprazole 30 mg.
14591|NCT02625259|P4|Participant Flow|Part-2: TAK-117 600 mg Fed + TAK-117 600 mg Fasted|TAK-117 2*300 mg, tablets (NTM), orally, once with a standard high-fat breakfast on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 2*300 mg, tablets (NTM), orally, in the fasted state, once on Day 15 (second intervention).
14592|NCT02625259|P3|Participant Flow|Part-2: TAK-117 600 mg Fasted + TAK-117 600 mg Fed|TAK-117 2*300 mg, tablets (NTM), orally, once in the fasted state on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 2*300 mg, tablets (NTM), orally, with a standard high-fat breakfast, once on Day 15 (second intervention).
14593|NCT02625259|P2|Participant Flow|Part-1: TAK-117 900 mg Tablets + TAK-117 900 mg Capsules|TAK-117 3*300 mg, tablets (NTM), orally, once on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 9*100 mg, capsules (CTM), orally, once on Day 15 (second intervention).
14594|NCT02625259|P1|Participant Flow|Part-1: TAK-117 900 mg Capsules + TAK-117 900 mg Tablets|TAK-117 9*100 mg, capsules (current clinical trial material [CTM]), orally, once on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 3*300 mg, tablets (new clinical trial material [NTM]), orally, once on Day 15 (second intervention).
14595|NCT02625259|O2|Outcome|Part-1: TAK-117 900 mg Tablets (3*300 mg Tablets)|TAK-117 3*300 mg, tablets (NTM), orally, once on Day 1 or 15 of intervention period.
14596|NCT02625259|O1|Outcome|Part-1: TAK-117 900 mg Capsules (9*100 mg Capsules)|TAK-117 9*100 mg, capsules (CTM), orally, once on Day 1 or 15 of intervention period.
14597|NCT02625259|O6|Outcome|Part-3: TAK-117 900 mg (3*300 mg Tablets) + Lansoprazole 30 mg|Lansoprazole 30 mg, capsule, orally, once daily from Day 10 to Day 15 along with TAK-117 3*300 mg, tablets (NTM), orally once on Day 15.
14598|NCT02625259|O5|Outcome|Part-3: TAK-117 900 mg (3*300 mg Tablets)|TAK-117 3*300 mg, tablets (NTM), orally, once on Day 1.
14599|NCT02625259|O4|Outcome|Part-2: TAK-117 600 mg Fed (2*300 mg Tablets)|TAK-117 2*300 mg, tablets (NTM), orally, with a standard high-fat breakfast, once on Day 1 or 15 of intervention period.
14600|NCT02625259|O3|Outcome|Part-2: TAK-117 600 mg Fasted (2*300 mg Tablets)|TAK-117 2*300 mg, tablets (NTM), orally, once in a fasted state on Day 1 or 15 of intervention period.
14601|NCT02625259|O2|Outcome|Part-1: TAK-117 900 mg Tablets (3*300 mg Tablets)|TAK-117 3*300 mg, tablets (NTM), orally, once on Day 1 or 15 of intervention period.
14602|NCT02625259|O1|Outcome|Part-1: TAK-117 900 mg Capsules (9*100 mg Capsules)|TAK-117 9*100 mg, capsules (CTM), orally, once on Day 1 or 15 of intervention period.
14603|NCT02625259|O6|Outcome|Part-3: TAK-117 900 mg (3*300 mg Tablets) + Lansoprazole 30 mg|Lansoprazole 30 mg, capsule, orally, once daily from Day 10 to Day 15 along with TAK-117 3*300 mg, tablets (NTM), orally once on Day 15.
14604|NCT02625259|O5|Outcome|Part-3: TAK-117 900 mg (3*300 mg Tablets)|TAK-117 3*300 mg, tablets (NTM), orally, once on Day 1.
14605|NCT02625259|O4|Outcome|Part-2: TAK-117 600 mg Fed (2*300 mg Tablets)|TAK-117 2*300 mg, tablets (NTM), orally, with a standard high-fat breakfast, once on Day 1 or 15 of intervention period.
14606|NCT02625259|O3|Outcome|Part-2: TAK-117 600 mg Fasted (2*300 mg Tablets)|TAK-117 2*300 mg, tablets (NTM), orally, once in a fasted state on Day 1 or 15 of intervention period.
14607|NCT02625259|O2|Outcome|Part-1: TAK-117 900 mg Tablets (3*300 mg Tablets)|TAK-117 3*300 mg, tablets (NTM), orally, once on Day 1 or 15 of intervention period.
14608|NCT02625259|O1|Outcome|Part-1: TAK-117 900 mg Capsules (9*100 mg Capsules)|TAK-117 9*100 mg, capsules (CTM), orally, once on Day 1 or 15 of intervention period.
14609|NCT02625259|O6|Outcome|Part-3: TAK-117 900 mg (3*300 mg Tablets) + Lansoprazole 30 mg|Lansoprazole 30 mg, capsule, orally, once daily from Day 10 to Day 15 along with TAK-117 3*300 mg, tablets (NTM), orally once on Day 15.
14610|NCT02625259|O5|Outcome|Part-3: TAK-117 900 mg (3*300 mg Tablets)|TAK-117 3*300 mg, tablets (NTM), orally, once on Day 1.
14611|NCT02625259|O4|Outcome|Part-2: TAK-117 600 mg Fed (2*300 mg Tablets)|TAK-117 2*300 mg, tablets (NTM), orally, with a standard high-fat breakfast, once on Day 1 or 15 of intervention period.
14612|NCT02625259|O3|Outcome|Part-2: TAK-117 600 mg Fasted (2*300 mg Tablets)|TAK-117 2*300 mg, tablets (NTM), orally, once in a fasted state on Day 1 or 15 of intervention period.
14613|NCT02625259|O2|Outcome|Part-1: TAK-117 900 mg Tablets (3*300 mg Tablets)|TAK-117 3*300 mg, tablets (NTM), orally, once on Day 1 or 15 of intervention period.
14614|NCT02625259|O1|Outcome|Part-1: TAK-117 900 mg Capsules (9*100 mg Capsules)|TAK-117 9*100 mg, capsules (CTM), orally, once on Day 1 or 15 of intervention period.
14615|NCT02625259|O6|Outcome|Part-3: TAK-117 900 mg (3*300 mg Tablets) + Lansoprazole 30 mg|Lansoprazole 30 mg, capsule, orally, once daily from Day 10 to Day 15 along with TAK-117 3*300 mg, tablets (NTM), orally once on Day 15.
14616|NCT02625259|O5|Outcome|Part-3: TAK-117 900 mg (3*300 mg Tablets)|TAK-117 3*300 mg, tablets (NTM), orally, once on Day 1.
14617|NCT02625259|O4|Outcome|Part-2: TAK-117 600 mg Fed (2*300 mg Tablets)|TAK-117 2*300 mg, tablets (NTM), orally, with a standard high-fat breakfast, once on Day 1 or 15 of intervention period.
14618|NCT02625259|O3|Outcome|Part-2: TAK-117 600 mg Fasted (2*300 mg Tablets)|TAK-117 2*300 mg, tablets (NTM), orally, once in a fasted state on Day 1 or 15 of intervention period.
20076|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
14627|NCT02625259|E1|Reported Event|Part-1: TAK-117 900 mg Capsules|TAK-117 9*100 mg, capsules (CTM), orally, once on Day 1 or 15 of intervention period.
14628|NCT02625233|B3|Baseline|Total|Total of all reporting groups
14629|NCT02625233|B2|Baseline|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire duration of the study.
14630|NCT02625233|B1|Baseline|Senofilcon C|Subjects that wore the senofilcon C lens throughout the entire duration of the study.
14631|NCT02625233|P2|Participant Flow|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire duration of the study.
14632|NCT02625233|P1|Participant Flow|Senofilcon C|Subjects that wore the senofilcon C lens throughout the entire duration of the study.
14633|NCT02625233|O2|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire duration of the study.
14634|NCT02625233|O1|Outcome|Senofilcon C|Subjects that wore the senofilcon C lens througout the entire duration of the study.
14635|NCT02625233|O2|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire duration of the study.
14636|NCT02625233|O1|Outcome|Senofilcon C|Subjects that wore the senofilcon C lens througout the entire duration of the study.
14637|NCT02625233|E2|Reported Event|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire duration of the study.
14638|NCT02625233|E1|Reported Event|Senofilcon C|Subjects that wore the senofilcon C lens throughout the entire duration of the study.
14639|NCT02625220|B1|Baseline|Prototype Toric Lens Senofilcon A|All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
14640|NCT02625220|P1|Participant Flow|Prototype Toric Lens Senofilcon A|All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
14641|NCT02625220|O1|Outcome|Prototype Toric Lens Senofilcon A|All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
14642|NCT02625220|O1|Outcome|Prototype Toric Lens Senofilcon A|All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
14643|NCT02625220|O1|Outcome|Prototype Toric Lens Senofilcon A|All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
14644|NCT02625220|O1|Outcome|Prototype Toric Lens Senofilcon A|All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
14645|NCT02625220|E1|Reported Event|Prototype Toric Lens Senofilcon A|All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
14646|NCT02625207|B5|Baseline|Total|Total of all reporting groups
14647|NCT02625207|B4|Baseline|Part 1: Cohort 4 - No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14648|NCT02625207|B3|Baseline|Part 1 and 2: Cohort 3 - Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1, followed by maraviroc 150 mg tablet once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
14649|NCT02625207|B2|Baseline|Part 1: Cohort 2 - One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14650|NCT02625207|B1|Baseline|Part 1 and Part 2: Cohort 1 -No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1, followed by maraviroc 150 mg tablet once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
14651|NCT02625207|P4|Participant Flow|Part 1: Cohort 4 - No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14652|NCT02625207|P3|Participant Flow|Part 1 and 2: Cohort 3 - Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1, followed by maraviroc 150 mg tablet once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
14653|NCT02625207|P2|Participant Flow|Part 1: Cohort 2 - One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14654|NCT02625207|P1|Participant Flow|Part 1 and Part 2: Cohort 1 -No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 milligram (mg) tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1, followed by maraviroc 150 mg tablet once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
14655|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
14656|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
14657|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14658|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14659|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14660|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14661|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
14662|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
14663|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14664|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14665|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14666|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14667|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
14668|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
14669|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14670|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14671|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14672|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14673|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
14674|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
14675|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14676|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14677|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14678|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14679|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14680|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14681|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14682|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14683|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14684|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14685|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14686|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14687|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14688|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14689|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14690|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
15702|NCT02609113|O1|Outcome|Strong Magnetic Wristband|"Magnetic wristband of 1,795 Gauss strength~Strong Magnetic Wristband"
14691|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14692|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14693|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14694|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14695|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14696|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14697|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14698|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14699|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
14700|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
14701|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14702|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14703|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14704|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14705|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
14706|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
14707|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14708|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14709|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14710|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14711|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
14712|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
14713|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14714|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14715|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14716|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14717|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
14718|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
14719|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
20077|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
14720|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14721|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14722|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14723|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14724|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14725|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14726|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14727|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
14728|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
14729|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14730|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14731|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14732|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14733|NCT02625207|E6|Reported Event|Part 2: Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
14734|NCT02625207|E5|Reported Event|Part 2: Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
14735|NCT02625207|E4|Reported Event|Part 1: Cohort 4 - No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14736|NCT02625207|E3|Reported Event|Part 1: Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14737|NCT02625207|E2|Reported Event|Part 1: Cohort 2- One CYP3A5*1 Allele|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14738|NCT02625207|E1|Reported Event|Part 1: Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
14739|NCT02624791|B1|Baseline|All Study Participants|
14740|NCT02624791|P6|Participant Flow|Lens Sequence 6|Toric; Sphere; None
14741|NCT02624791|P5|Participant Flow|Lens Sequence 5|Toric; None; Sphere
14742|NCT02624791|P4|Participant Flow|Lens Sequence 4|Sphere; Toric; None
14743|NCT02624791|P3|Participant Flow|Lens Sequence 3|Sphere; None; Toric
14744|NCT02624791|P2|Participant Flow|Lens Sequence 2|None; Toric; Sphere
14745|NCT02624791|P1|Participant Flow|Lens Sequence 1|None; Sphere; Toric
14746|NCT02624791|O1|Outcome|Contact Lens Rx|All study participants
14747|NCT02624791|O1|Outcome|Contact Lens Rx|All study participants
14748|NCT02624791|E1|Reported Event|Contact Lens Rx|None; Sphere; Toric
14749|NCT02622568|B3|Baseline|Total|Total of all reporting groups
14750|NCT02622568|B2|Baseline|Veregen Only|"Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children’s Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.~Veregen or Sinecatechins"
14751|NCT02622568|B1|Baseline|Cryotherapy + Veregen|"Cryotherapy will be performed on the day of first clinic visit according to current standard of care in Children’s Medical Center pediatric outpatient dermatology clinic, which consists of two freeze/thaw cycles for maximum of 10 seconds each. Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children’s Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.~Veregen or Sinecatechins + cryotherapy"
20078|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
14752|NCT02622568|P2|Participant Flow|Veregen Only|"Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children’s Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.~Veregen or Sinecatechins"
14753|NCT02622568|P1|Participant Flow|Cryotherapy + Veregen|"Cryotherapy will be performed on the day of first clinic visit according to current standard of care in Children’s Medical Center pediatric outpatient dermatology clinic, which consists of two freeze/thaw cycles for maximum of 10 seconds each. Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children’s Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.~Veregen or Sinecatechins"
14754|NCT02622568|O2|Outcome|Veregen Only|"Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children’s Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.~Veregen or Sinecatechins"
14755|NCT02622568|O1|Outcome|Cryotherapy + Veregen|"Cryotherapy will be performed on the day of first clinic visit according to current standard of care in Children’s Medical Center pediatric outpatient dermatology clinic, which consists of two freeze/thaw cycles for maximum of 10 seconds each. Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children’s Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.~Veregen or Sinecatechins following cryotherapy"
14756|NCT02622568|E2|Reported Event|Veregen Only|"Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children’s Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.~Veregen or Sinecatechins"
14757|NCT02622568|E1|Reported Event|Cryotherapy + Veregen|"Cryotherapy will be performed on the day of first clinic visit according to current standard of care in Children’s Medical Center pediatric outpatient dermatology clinic, which consists of two freeze/thaw cycles for maximum of 10 seconds each. Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children’s Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.~Veregen or Sinecatechins"
14758|NCT02622321|B5|Baseline|Total|Total of all reporting groups
14759|NCT02622321|B4|Baseline|Arm D (Episodic or Prophylactic Treatment): Emicizumab|Participants, who received episodic bypassing agents prior to study entry, who participated in Study BH29768 but were unable to enroll in Arms A or B, were enrolled in this arm to receive prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14760|NCT02622321|B3|Baseline|Arm C (Prophylactic Treatment): Emicizumab|Participants, who received prophylactic bypassing agents prior to study entry, received prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14761|NCT02622321|B2|Baseline|Arm B (Episodic Treatment): No Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, did not receive emicizumab prophylaxis. Participants in this arm could switch to emicizumab prophylaxis after completing at least 24 weeks on study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14762|NCT02622321|B1|Baseline|Arm A (Episodic Treatment): Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, received prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive episodic bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14763|NCT02622321|P4|Participant Flow|Arm D (Episodic or Prophylactic Treatment): Emicizumab|Participants, who received episodic bypassing agents prior to study entry, who participated in Study BH29768 but were unable to enroll in Arms A or B, were enrolled in this arm to receive prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14764|NCT02622321|P3|Participant Flow|Arm C (Prophylactic Treatment): Emicizumab|Participants, who received prophylactic bypassing agents prior to study entry, received prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14765|NCT02622321|P2|Participant Flow|Arm B (Episodic Treatment): No Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, did not receive emicizumab prophylaxis. Participants in this arm could switch to emicizumab prophylaxis after completing at least 24 weeks on study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14766|NCT02622321|P1|Participant Flow|Arm A (Episodic Treatment): Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, received prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 milligrams per kilogram per week (mg/kg/week) subcutaneously (SC) for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive episodic bypassing agent therapy to treat breakthrough bleeds, with recombinant activated factor VII (rFVIIa) and/or activated prothrombin complex concentrate (aPCC).
14767|NCT02622321|O4|Outcome|Arm D (Episodic or Prophylactic Treatment): Emicizumab|Participants, who received episodic bypassing agents prior to study entry, who participated in Study BH29768 but were unable to enroll in Arms A or B, were enrolled in this arm to receive prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14768|NCT02622321|O3|Outcome|Arm C (Prophylactic Treatment): Emicizumab|Participants, who received prophylactic bypassing agents prior to study entry, received prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14769|NCT02622321|O2|Outcome|Arm Bemi: Emicizumab After Week 24|This arm includes Arm B participants who switched to emicizumab prophylaxis after completing at least 24-week no prophylaxis. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks (after at least 24 weeks) followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study.
14770|NCT02622321|O1|Outcome|Arm A (Episodic Treatment): Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, received prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive episodic bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14771|NCT02622321|O4|Outcome|Arm D (Episodic or Prophylactic Treatment): Emicizumab|Participants, who received episodic bypassing agents prior to study entry, who participated in Study BH29768 but were unable to enroll in Arms A or B, were enrolled in this arm to receive prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14772|NCT02622321|O3|Outcome|Arm C (Prophylactic Treatment): Emicizumab|Participants, who received prophylactic bypassing agents prior to study entry, received prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14773|NCT02622321|O2|Outcome|Arm Bemi: Emicizumab After Week 24|This arm includes Arm B participants who switched to emicizumab prophylaxis after completing at least 24-week no prophylaxis. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks (after at least 24 weeks) followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study.
14774|NCT02622321|O1|Outcome|Arm A (Episodic Treatment): Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, received prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive episodic bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14775|NCT02622321|O2|Outcome|Arm B (Episodic Treatment): No Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, did not receive emicizumab prophylaxis. Participants in this arm could switch to emicizumab prophylaxis after completing at least 24 weeks on study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14776|NCT02622321|O1|Outcome|Arm A (Episodic Treatment): Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, received prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive episodic bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14777|NCT02622321|O2|Outcome|Arm B (Episodic Treatment): No Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, did not receive emicizumab prophylaxis. Participants in this arm could switch to emicizumab prophylaxis after completing at least 24 weeks on study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14778|NCT02622321|O1|Outcome|Arm A (Episodic Treatment): Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, received prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive episodic bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14779|NCT02622321|O2|Outcome|Arm B (Episodic Treatment): No Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, did not receive emicizumab prophylaxis. Participants in this arm could switch to emicizumab prophylaxis after completing at least 24 weeks on study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14780|NCT02622321|O1|Outcome|Arm A (Episodic Treatment): Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, received prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive episodic bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
20079|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
14781|NCT02622321|O2|Outcome|Arm B (Episodic Treatment): No Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, did not receive emicizumab prophylaxis. Participants in this arm could switch to emicizumab prophylaxis after completing at least 24 weeks on study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14782|NCT02622321|O1|Outcome|Arm A (Episodic Treatment): Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, received prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive episodic bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14783|NCT02622321|O2|Outcome|Arm B (Episodic Treatment): No Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, did not receive emicizumab prophylaxis. Participants in this arm could switch to emicizumab prophylaxis after completing at least 24 weeks on study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14784|NCT02622321|O1|Outcome|Arm A (Episodic Treatment): Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, received prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive episodic bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14785|NCT02622321|O2|Outcome|Arm B (Episodic Treatment): No Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, did not receive emicizumab prophylaxis. Participants in this arm could switch to emicizumab prophylaxis after completing at least 24 weeks on study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14786|NCT02622321|O1|Outcome|Arm A (Episodic Treatment): Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, received prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive episodic bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14787|NCT02622321|O2|Outcome|Arm B (Episodic Treatment): No Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, did not receive emicizumab prophylaxis. Participants in this arm could switch to emicizumab prophylaxis after completing at least 24 weeks on study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14788|NCT02622321|O1|Outcome|Arm A (Episodic Treatment): Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, received prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive episodic bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14789|NCT02622321|O2|Outcome|Arm Cnis: Prophylactic Bypassing Agents in NIS BH29768|This arm includes data up to 52 weeks before study entry (assessed retrospectively at baseline) from Arm C participants who participated in NIS BH29768 before study entry and received prophylactic bypassing agents (rFVIIa or/and aPCC) during NIS BH29768.
14790|NCT02622321|O1|Outcome|Arm C (Prophylactic Treatment): Emicizumab|Participants, who received prophylactic bypassing agents prior to study entry, received prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14791|NCT02622321|O2|Outcome|Arm Cnis: Prophylactic Bypassing Agents in NIS BH29768|This arm includes data up to 52 weeks before study entry (assessed retrospectively at baseline) from Arm C participants who participated in NIS BH29768 before study entry and received prophylactic bypassing agents (rFVIIa or/and aPCC) during NIS BH29768.
14792|NCT02622321|O1|Outcome|Arm C (Prophylactic Treatment): Emicizumab|Participants, who received prophylactic bypassing agents prior to study entry, received prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14793|NCT02622321|O2|Outcome|Arm B (Episodic Treatment): No Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, did not receive emicizumab prophylaxis. Participants in this arm could switch to emicizumab prophylaxis after completing at least 24 weeks on study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14794|NCT02622321|O1|Outcome|Arm A (Episodic Treatment): Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, received prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive episodic bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14795|NCT02622321|O2|Outcome|Arm Anis: Episodic Bypassing Agents in NIS BH29768|This arm includes data up to 52 weeks before study entry (assessed retrospectively at baseline) from Arm A participants who participated in NIS BH29768 before study entry and received episodic bypassing agents (rFVIIa or/and aPCC) during NIS BH29768.
14796|NCT02622321|O1|Outcome|Arm A (Episodic Treatment): Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, received prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive episodic bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14797|NCT02622321|O2|Outcome|Arm Anis: Episodic Bypassing Agents in NIS BH29768|This arm includes data up to 52 weeks before study entry (assessed retrospectively at baseline) from Arm A participants who participated in NIS BH29768 before study entry and received episodic bypassing agents (rFVIIa or/and aPCC) during NIS BH29768.
14898|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
14798|NCT02622321|O1|Outcome|Arm A (Episodic Treatment): Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, received prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive episodic bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14799|NCT02622321|O2|Outcome|Arm B (Episodic Treatment): No Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, did not receive emicizumab prophylaxis. Participants in this arm could switch to emicizumab prophylaxis after completing at least 24 weeks on study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14800|NCT02622321|O1|Outcome|Arm A (Episodic Treatment): Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, received prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive episodic bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14801|NCT02622321|O2|Outcome|Arm B (Episodic Treatment): No Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, did not receive emicizumab prophylaxis. Participants in this arm could switch to emicizumab prophylaxis after completing at least 24 weeks on study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14802|NCT02622321|O1|Outcome|Arm A (Episodic Treatment): Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, received prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive episodic bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14803|NCT02622321|E5|Reported Event|Arm Bemi: Emicizumab After Week 24|This arm includes Arm B participants who switched to emicizumab prophylaxis after completing at least 24-week no prophylaxis. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks (after at least 24 weeks) followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Data reported represents data collected during emicizumab treatment only.
14804|NCT02622321|E4|Reported Event|Arm D (Episodic or Prophylactic Treatment): Emicizumab|Participants, who received episodic bypassing agents prior to study entry, who participated in Study BH29768 but were unable to enroll in Arms A or B, were enrolled in this arm to receive prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14805|NCT02622321|E3|Reported Event|Arm C (Prophylactic Treatment): Emicizumab|Participants, who received prophylactic bypassing agents prior to study entry, received prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14806|NCT02622321|E2|Reported Event|Arm B (Episodic Treatment): No Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, did not receive emicizumab prophylaxis. Participants in this arm could switch to emicizumab prophylaxis after completing at least 24 weeks on study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC. Data reported for this arm represents data collected from all Arm B participants during 'no emicizumab' treatment; data from those participants who switched to emicizumab after at least 24 weeks is reported separately in Arm Bemi.
14807|NCT02622321|E1|Reported Event|Arm A (Episodic Treatment): Emicizumab|Participants, who received episodic treatment with bypassing agents prior to study entry, received prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive episodic bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
14808|NCT02621034|B4|Baseline|Total|Total of all reporting groups
14809|NCT02621034|B3|Baseline|One Shape|"one shape continuous rotation protocol~One shape: full rotation protocol"
14810|NCT02621034|B2|Baseline|Reciproc|"rotary reciprocating protocol~Reciproc: reciprocating rotary instrument"
14811|NCT02621034|B1|Baseline|Control|"K-file hand instrumentation~Control: K-file hand instrumentation"
14812|NCT02621034|P3|Participant Flow|One Shape|"one shape continuous rotation protocol~One shape: full rotation protocol"
14813|NCT02621034|P2|Participant Flow|Reciproc|"rotary reciprocating protocol~Reciproc: reciprocating rotary instrument"
14814|NCT02621034|P1|Participant Flow|k File|"hand instrumentation~k file: hand instrumentation"
14815|NCT02621034|O3|Outcome|One Shape|"one shape continuous rotation protocol~One shape: full rotation protocol"
14816|NCT02621034|O2|Outcome|Reciproc|"rotary reciprocating protocol~Reciproc: reciprocating rotary instrument"
14817|NCT02621034|O1|Outcome|Control|"K-file hand instrumentation~Control: K-file hand instrumentation"
14818|NCT02621034|O2|Outcome|One Shape|"one shape continuous rotation protocol~One shape: full rotation protocol"
14819|NCT02621034|O1|Outcome|Reciproc|"rotary reciprocating protocol~Reciproc: reciprocating rotary instrument"
14820|NCT02621034|O3|Outcome|One Shape|"one shape continuous rotation protocol~One shape: full rotation protocol"
14821|NCT02621034|O2|Outcome|Reciproc|"rotary reciprocating protocol~Reciproc: reciprocating rotary instrument"
14822|NCT02621034|O1|Outcome|Control|"K-file hand instrumentation~Control: K-file hand instrumentation"
14823|NCT02621034|E3|Reported Event|One Shape|"one shape continuous rotation protocol~One shape: full rotation protocol"
14824|NCT02621034|E2|Reported Event|Reciproc|"rotary reciprocating protocol~Reciproc: reciprocating rotary instrument"
14825|NCT02621034|E1|Reported Event|Control|"K-file hand instrumentation~Control: K-file hand instrumentation"
14826|NCT02620683|B1|Baseline|All Study Participants|Subjects who were randomized to receive either Buffered or Non-Buffered Lidocaine
15319|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
20080|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
14827|NCT02620683|P2|Participant Flow|Non-buffered Lidocaine, Then Buffererd Lidocaine|At Visit 1 each subject received Non-Buffered Lidocaine anesthetic to block the inferior alveolar and lingual N; using Halstead or Gow-Gates techniques. No Buccal N. block. Venous blood samples were drawn from the antecubital fossa 30min post oral injection and assayed for blood lidocaine levels. Following a 2-week washout, subjects received Buffered Lidocaine in the same fashion at Visit 2.
14828|NCT02620683|P1|Participant Flow|Buffered Lidocaine, Then Non-buffered Lidocaine|At Visit 1 each subject received Buffered Lidocaine anesthetic to block the inferior alveolar and lingual N; using Halstead or Gow-Gates techniques. No Buccal N. block. Venous blood samples were drawn from the antecubital fossa 30min post oral injection and assayed for blood lidocaine levels. Following a 2-week washout, subjects received Non-buffered Lidocaine in the same fashion at Visit 2.
14829|NCT02620683|O1|Outcome|Buffered Lidocaine and Non-Buffered Lidocaine|At Visit 1 each subject received Buffered Lidocaine anesthetic to block the inferior alveolar and lingual N; using Halstead or Gow-Gates techniques. No Buccal N. block. Venous blood samples were drawn from the antecubital fossa 30min post oral injection and assayed for blood lidocaine levels. Following a 2-week washout, subjects received Non-buffered Lidocaine in the same fashion at Visit 2.
14830|NCT02620683|O1|Outcome|Buffered Lidocaine and Non-Buffered Lidocaine|At Visit 1 each subject received Buffered Lidocaine anesthetic to block the inferior alveolar and lingual N; using Halstead or Gow-Gates techniques. No Buccal N. block. Venous blood samples were drawn from the antecubital fossa 30min post oral injection and assayed for blood lidocaine levels. Following a 2-week washout, subjects received Non-buffered Lidocaine in the same fashion at Visit 2.
14831|NCT02620683|O1|Outcome|Buffered Lidocaine and Non-Buffered Lidocaine|At Visit 1 each subject received Buffered Lidocaine anesthetic to block the inferior alveolar and lingual N; using Halstead or Gow-Gates techniques. No Buccal N. block. Venous blood samples were drawn from the antecubital fossa 30min post oral injection and assayed for blood lidocaine levels. Following a 2-week washout, subjects received Non-buffered Lidocaine in the same fashion at Visit 2.
14832|NCT02620683|O1|Outcome|Buffered Lidocaine and Non-Buffered Lidocaine|At Visit 1 each subject received Buffered Lidocaine anesthetic to block the inferior alveolar and lingual N; using Halstead or Gow-Gates techniques. No Buccal N. block. Venous blood samples were drawn from the antecubital fossa 30min post oral injection and assayed for blood lidocaine levels. Following a 2-week washout, subjects received Non-buffered Lidocaine in the same fashion at Visit 2.
14833|NCT02620683|E2|Reported Event|Non-bufered Lidocaine|"In week One each subject would receive anesthetic to block the inferior alveolar and lingual N; Halstead or Gow-Gates techniques. No Buccal N. block. At least a week later injections would involve the alternate local anesthetic combination.~Venous blood samples would be drawn from the antecubital fossa 30min post oral injection and assayed for blood lidocaine levels~Lidocaine: See above"
14834|NCT02620683|E1|Reported Event|Buffered Lidicaine|"In week One each subject would receive anesthetic to block the inferior alveolar and lingual N; Halstead or Gow-Gates techniques. No Buccal N. block.~Venous blood samples would be drawn from the antecubital fossa 30min post oral injection and assayed for blood lidocaine levels~Lidocaine: See above"
14835|NCT02619812|B5|Baseline|Total|Total of all reporting groups
14836|NCT02619812|B4|Baseline|Group D: Double Placebo|Double Placebo: Double placebo twice per day (Subjects took a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
14837|NCT02619812|B3|Baseline|Group C: Colesevelam + SBI|Colesevelam 1.875 g + SBI 10 grams twice per day.
14838|NCT02619812|B2|Baseline|Group B: Colesevelam + Placebo|Colesevelam 1.875 g + Placebo twice per day
14839|NCT02619812|B1|Baseline|Group A: SBI + Placebo|SBI 10 grams + placebo twice per day.
14840|NCT02619812|P4|Participant Flow|Group D: Double Placebo|Double Placebo: Double placebo twice per day (Subjects took a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
14841|NCT02619812|P3|Participant Flow|Group C: Colesevelam + SBI|Colesevelam 1.875 g + SBI 10 grams twice per day.
14842|NCT02619812|P2|Participant Flow|Group B: Colesevelam + Placebo|Colesevelam 1.875 g + Placebo twice per day
14843|NCT02619812|P1|Participant Flow|Group A: SBI + Placebo|SBI 10 grams + placebo twice per day.
14844|NCT02619812|O4|Outcome|Group D: Double Placebo|Double Placebo: Double placebo twice per day (Subjects took a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
14845|NCT02619812|O3|Outcome|Group C: Colesevelam + SBI|Colesevelam 1.875 g + SBI 10 grams twice per day.
14846|NCT02619812|O2|Outcome|Group B: Colesevelam + Placebo|Colesevelam 1.875 g + Placebo twice per day
14847|NCT02619812|O1|Outcome|Group A: SBI + Placebo|SBI 10 grams + placebo twice per day.
14848|NCT02619812|O4|Outcome|Group D: Double Placebo|Double Placebo: Double placebo twice per day (Subjects took a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
14849|NCT02619812|O3|Outcome|Group C: Colesevelam + SBI|Colesevelam 1.875 g + SBI 10 grams twice per day.
14850|NCT02619812|O2|Outcome|Group B: Colesevelam + Placebo|Colesevelam 1.875 g + Placebo twice per day
14851|NCT02619812|O1|Outcome|Group A: SBI + Placebo|SBI 10 grams + placebo twice per day.
14852|NCT02619812|E4|Reported Event|Group D: Double Placebo|Double Placebo: Double placebo twice per day (Subjects took a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
14853|NCT02619812|E3|Reported Event|Group C: Colesevelam + SBI|Colesevelam 1.875 g + SBI 10 grams twice per day.
14854|NCT02619812|E2|Reported Event|Group B: Colesevelam + Placebo|Colesevelam 1.875 g + Placebo twice per day
14855|NCT02619812|E1|Reported Event|Group A: SBI + Placebo|SBI 10 grams + placebo twice per day.
14856|NCT02619799|B3|Baseline|Total|Total of all reporting groups
14899|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
14857|NCT02619799|B2|Baseline|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
14858|NCT02619799|B1|Baseline|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
14859|NCT02619799|P2|Participant Flow|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
14860|NCT02619799|P1|Participant Flow|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
14861|NCT02619799|O2|Outcome|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
14862|NCT02619799|O1|Outcome|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
14863|NCT02619799|O2|Outcome|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
14864|NCT02619799|O1|Outcome|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
14865|NCT02619799|O2|Outcome|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
14866|NCT02619799|O1|Outcome|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
14867|NCT02619799|O2|Outcome|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
14868|NCT02619799|O1|Outcome|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
14869|NCT02619799|O2|Outcome|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
14870|NCT02619799|O1|Outcome|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
14871|NCT02619799|O2|Outcome|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
14872|NCT02619799|O1|Outcome|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
15320|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
17740|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
14873|NCT02619799|E2|Reported Event|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
14874|NCT02619799|E1|Reported Event|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
14875|NCT02619591|B3|Baseline|Total|Total of all reporting groups
14876|NCT02619591|B2|Baseline|Ultrasound Imaging - Multiple Views|"Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging: views of a hemithorax was obtained using the Zonare Ultrasound machine."
14877|NCT02619591|B1|Baseline|Ultrasound Imaging - Single View|"Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging: views of a hemithorax was obtained using the Zonare Ultrasound machine."
14878|NCT02619591|P2|Participant Flow|"Device - Ultrasound Imaging - Multiple Views"|"Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging Technique - Multiple Views: Multiple views of a hemithorax was obtained using the Zonare Ultrasound machine."
14879|NCT02619591|P1|Participant Flow|"Device - Ultrasound Imaging - Single View"|"Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging Technique - Single View: A single view of a hemithorax was obtained using the Zonare Ultrasound machine."
14880|NCT02619591|O2|Outcome|"Device - Ultrasound Imaging - Multiple Views"|"Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging Technique - Multiple Views: Multiple views of a hemithorax was obtained using the Zonare Ultrasound machine."
14881|NCT02619591|O1|Outcome|"Device - Ultrasound Imaging - Single View"|"Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging Technique - Single View: A single view of a hemithorax was obtained using the Zonare Ultrasound machine."
14882|NCT02619591|E2|Reported Event|"Device - Ultrasound Imaging - Multiple Views"|"Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging Technique - Multiple Views: Multiple views of a hemithorax was obtained using the Zonare Ultrasound machine."
14883|NCT02619591|E1|Reported Event|"Device - Ultrasound Imaging - Single View"|"Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging Technique - Single View: A single view of a hemithorax was obtained using the Zonare Ultrasound machine."
14884|NCT02618772|B3|Baseline|Total|Total of all reporting groups
14885|NCT02618772|B2|Baseline|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
14886|NCT02618772|B1|Baseline|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
14887|NCT02618772|P2|Participant Flow|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
14888|NCT02618772|P1|Participant Flow|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
14889|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
14890|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
14891|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
14892|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
14893|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
14894|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
14895|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
14896|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
14897|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
14900|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
14901|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
14902|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
14903|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
14904|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
14905|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
14906|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
14907|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
14908|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
14909|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
14910|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
14911|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
14912|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
14913|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
14914|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
14915|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
14916|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
14917|NCT02618772|E2|Reported Event|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
14918|NCT02618772|E1|Reported Event|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
14919|NCT02618512|B1|Baseline|SBC-103|Patients were administered 1 mg/kg by IV infusion once every other week (qow) for at least 12 weeks. After evaluation of 12-week safety, tolerability, and pharmacodynamic data in individual patients, the dose was increased to 3 mg/kg qow. Infusions were to be at least 10 days apart and were administered every 14 days ±5 days.
14920|NCT02618512|P1|Participant Flow|SBC-103|Patients were administered 1 mg/kg by IV infusion once every other week (qow) for at least 12 weeks. After evaluation of 12-week safety, tolerability, and pharmacodynamic data in individual patients, the dose was increased to 3 mg/kg qow. Infusions were to be at least 10 days apart and were administered every 14 days ±5 days.
14921|NCT02618512|O1|Outcome|SBC-103|Patients were administered 1 mg/kg by IV infusion once every other week (qow) for at least 12 weeks. After evaluation of 12-week safety, tolerability, and pharmacodynamic data in individual patients, the dose was increased to 3 mg/kg qow. Infusions were to be at least 10 days apart and were administered every 14 days ±5 days.
14922|NCT02618512|E1|Reported Event|SBC-103|Patients were administered 1 mg/kg by IV infusion once every other week (qow) for at least 12 weeks. After evaluation of 12-week safety, tolerability, and pharmacodynamic data in individual patients, the dose was increased to 3 mg/kg qow. Infusions were to be at least 10 days apart and were administered every 14 days ±5 days.
14950|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
14923|NCT02617901|B1|Baseline|Recruited Children|"Children aged below 16 years attending the Radiology Department for a left hand radiograph in order to assess bone age on the basis of clinical need. There was one male and one female from each of five age groups (< 5 years; 5 to 7 years; 8 to 10 years; 11 to 13 years; 14 to 16 years).~Recruited children had intervention in the form of a left hand DXA which was anonymised and from which the same 2 observers independently assessed bone age according to Greulich and Pyle method on 2 separate occasions at least 4 weeks apart.~Radiographs and DXA were read in random and varied order."
14924|NCT02617901|P1|Participant Flow|Recruited Children|"Children aged below 16 years attending the Radiology Department for a left hand radiograph in order to assess bone age on the basis of clinical need. There was one male and one female from each of five age groups (< 5 years; 5 to 7 years; 8 to 10 years; 11 to 13 years; 14 to 16 years).~Recruited children had intervention in the form of a left hand DXA which was anonymised and from which 2 observers independently assessed bone age according to Greulich and Pyle method on 2 separate occasions at least 4 weeks apart.~Radiographs and DXA were read in random and varied order."
14925|NCT02617901|O1|Outcome|Recruited Children|"Children aged below 16 years attending the Radiology Department for a left hand radiograph in order to assess bone age on the basis of clinical need. There will be one male and one female from each of five age groups (< 5 years; 5 to 7 years; 8 to 10 years; 11 to 13 years; 14 to 16 years).~All had left hand/wrist radiograph for bone age estimation"
14926|NCT02617901|E1|Reported Event|Recruited Children|Children aged below 16 years attending the Radiology Department for a left hand radiograph in order to assess bone age on the basis of clinical need. There will be one male and one female from each of five age groups (< 5 years; 5 to 7 years; 8 to 10 years; 11 to 13 years; 14 to 16 years).
14927|NCT02617888|B4|Baseline|Total|Total of all reporting groups
14928|NCT02617888|B3|Baseline|Observational Arm|1. Non-female patients undergoing coronary CTA; 2. Patients undergoing nuclear cardiology stress testing; 3. Patients undergoing invasive coronary angiography.
14929|NCT02617888|B2|Baseline|CCTA No Breast Shields|Within female subset, randomization to not wearing bismuth breast shield (standard of care).
14930|NCT02617888|B1|Baseline|CCTA Breast Shields|Within female subset, randomization to wearing bismuth breast shield.
14931|NCT02617888|P3|Participant Flow|Observational|Non-female patients undergoing coronary CTA, patients undergoing nuclear cardiology studies and invasive coronary angiography.
14932|NCT02617888|P2|Participant Flow|CCTA No Breast Shields|Within female subset, randomization to not wearing bismuth breast shield (standard of care).
14933|NCT02617888|P1|Participant Flow|CCTA Breast Shields|Within female subset, randomization to wearing bismuth breast shield.
14934|NCT02617888|O2|Outcome|Breast Shields|"Within female subset, randomization to wearing bismuth breast shield or not wearing bismuth breast shield (standard of care).~CCTA: Breast shield placement (randomized) among women."
14935|NCT02617888|O1|Outcome|No Breast Shields|"Within female subset, randomization to wearing bismuth breast shield or not wearing bismuth breast shield (standard of care).~CCTA: Breast shield placement (randomized) among women."
14936|NCT02617888|E3|Reported Event|Observational Arm|Observational evaluating the dose-related impact of radiation exposure from multiple sources and types on changes in double-stranded DNA breaks.
14937|NCT02617888|E2|Reported Event|CCTA No Breast Shields|Within female subset, randomization to not wearing bismuth breast shield (standard of care).
14938|NCT02617888|E1|Reported Event|CCTA Breast Shields|Within female subset, randomization to wearing bismuth breast shield.
14939|NCT02617784|B3|Baseline|Total|Total of all reporting groups
14940|NCT02617784|B2|Baseline|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
14941|NCT02617784|B1|Baseline|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
14942|NCT02617784|P2|Participant Flow|Oseltamivir With CAPD|Participants on continuous ambulatory peritoneal dialysis (CAPD) received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
14943|NCT02617784|P1|Participant Flow|Oseltamivir With HD|Participants on hemodialysis (HD) received 9 doses of 30-milligram (mg) oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
14944|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
14945|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
14946|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
14947|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
14948|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
14949|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
15001|NCT02616523|O1|Outcome|Dexmedetomidine|Participants received dexmedetomidine infusion intraoperatively 0,5 mcg/kg/h
17741|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
14951|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
14952|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
14953|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
14954|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
14955|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
14956|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
14957|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
14958|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
14959|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
14960|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
14961|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
14962|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
14963|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
14964|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
14965|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
14966|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
14967|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
14968|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
14969|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
14970|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
14971|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
14972|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
14973|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
14974|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
15103|NCT02614924|E2|Reported Event|Pentax AWS Videolaryngoscope|Randomly allocated to Pentax AWS group Pentax AWS videolaryngoscope group: Patient intubated with Pentax AWS
14975|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
14976|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
14977|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
14978|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
14979|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
14980|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
14981|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
14982|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
14983|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
14984|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
14985|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
14986|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
14987|NCT02617784|E2|Reported Event|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
14988|NCT02617784|E1|Reported Event|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
14989|NCT02616523|B4|Baseline|Total|Total of all reporting groups
14990|NCT02616523|B3|Baseline|Placebo|"The placebo group will receive intravenous infusion of normal saline only.~placebo: The participants will be given infusion of normal saline intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
14991|NCT02616523|B2|Baseline|Lidocaine|"Lidocaine group will receive lidocaine infusion 1,5 mg/kg/h during the laparoscopic intestine resection.~Lidocaine: The participants will be given infusion of lidocaine 1,5 mg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
14992|NCT02616523|B1|Baseline|Dexmedetomidine|"The investigators will compare fentanyl consumption in participants undergoing laparoscopic intestine resection intra and postoperatively. Dexmedetomidine group will receive dexmedetomidine infusion 0,5 mcg/kg/h beside boluses of fentanyl.~Dexmedetomidine: The participants will be given infusion of dexmedetomidine 0,5 mcg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
14993|NCT02616523|P3|Participant Flow|Placebo|"The placebo group will receive intravenous infusion of normal saline only.~placebo: The participants will be given infusion of normal saline intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
14994|NCT02616523|P2|Participant Flow|Lidocaine|"Lidocaine group will receive lidocaine infusion 1,5 mg/kg/h during the laparoscopic intestine resection.~Lidocaine: The participants will be given infusion of lidocaine 1,5 mg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
14995|NCT02616523|P1|Participant Flow|Dexmedetomidine|"The investigators will compare fentanyl consumption in participants undergoing laparoscopic intestine resection intra and postoperatively. Dexmedetomidine group will receive dexmedetomidine infusion 0,5 mcg/kg/h beside boluses of fentanyl.~Dexmedetomidine: The participants will be given infusion of dexmedetomidine 0,5 mcg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
14996|NCT02616523|O3|Outcome|Placebo|Participants received fentanyl boluses during the operation
14997|NCT02616523|O2|Outcome|Lidocaine|Participants received lidocaine infusion intraoperatively 1,5 mg/kg/h
14998|NCT02616523|O1|Outcome|Dexmedetomidine|Participants received dexmedetomidine infusion intraoperatively 0,5 mcg/kg/h
14999|NCT02616523|O3|Outcome|Placebo|Participants received fentanyl boluses during the operation
15000|NCT02616523|O2|Outcome|Lidocaine|Participants received lidocaine infusion intraoperatively 1,5 mg/kg/h
20081|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
15002|NCT02616523|O3|Outcome|Placebo|"The placebo group will receive intravenous infusion of normal saline only.~placebo: The participants will be given infusion of normal saline intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
15003|NCT02616523|O2|Outcome|Lidocaine|"Lidocaine group will receive lidocaine infusion 1,5 mg/kg/h during the laparoscopic intestine resection.~Lidocaine: The participants will be given infusion of lidocaine 1,5 mg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
15004|NCT02616523|O1|Outcome|Dexmedetomidine|"The investigators will compare fentanyl consumption in participants undergoing laparoscopic intestine resection intra and postoperatively. Dexmedetomidine group will receive dexmedetomidine infusion 0,5 mcg/kg/h beside boluses of fentanyl.~Dexmedetomidine: The participants will be given infusion of dexmedetomidine 0,5 mcg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
15005|NCT02616523|E3|Reported Event|Placebo|"The placebo group will receive intravenous infusion of normal saline only.~placebo: The participants will be given infusion of normal saline intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
15006|NCT02616523|E2|Reported Event|Lidocaine|"Lidocaine group will receive lidocaine infusion 1,5 mg/kg/h during the laparoscopic intestine resection.~Lidocaine: The participants will be given infusion of lidocaine 1,5 mg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
15007|NCT02616523|E1|Reported Event|Dexmedetomidine|"The investigators will compare fentanyl consumption in participants undergoing laparoscopic intestine resection intra and postoperatively. Dexmedetomidine group will receive dexmedetomidine infusion 0,5 mcg/kg/h beside boluses of fentanyl.~Dexmedetomidine: The participants will be given infusion of dexmedetomidine 0,5 mcg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
15008|NCT02616250|B3|Baseline|Total|Total of all reporting groups
15009|NCT02616250|B2|Baseline|CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream|"Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks.~CD07805/47 (Br) placebo gel~CD5024 (IVM) placebo cream"
15010|NCT02616250|B1|Baseline|Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream|"Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks.~Half group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks.~Brimonidine 0.33% gel (Br)~CD07805/47 (Br) placebo gel~Ivermectin 1% cream (IVM)"
15011|NCT02616250|P2|Participant Flow|CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream|"Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks.~CD07805/47 (Br) placebo gel~CD5024 (IVM) placebo cream"
15012|NCT02616250|P1|Participant Flow|Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream|"Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks.~Half group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks.~Brimonidine 0.33% gel (Br)~CD07805/47 (Br) placebo gel~Ivermectin 1% cream (IVM)"
15013|NCT02616250|O2|Outcome|CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream|"Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks.~CD07805/47 (Br) placebo gel~CD5024 (IVM) placebo cream"
15014|NCT02616250|O1|Outcome|Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream|"Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks.~Half group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks.~Brimonidine 0.33% gel (Br)~CD07805/47 (Br) placebo gel~Ivermectin 1% cream (IVM)"
15015|NCT02616250|E2|Reported Event|CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream|"Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks.~CD07805/47 (Br) placebo gel~CD5024 (IVM) placebo cream"
15016|NCT02616250|E1|Reported Event|Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream|"Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks.~Half group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks.~Brimonidine 0.33% gel (Br)~CD07805/47 (Br) placebo gel~Ivermectin 1% cream (IVM)"
15017|NCT02615990|B3|Baseline|Total|Total of all reporting groups
15018|NCT02615990|B2|Baseline|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
15019|NCT02615990|B1|Baseline|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
15020|NCT02615990|P2|Participant Flow|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
15104|NCT02614924|E1|Reported Event|Flexible Fibre-optic Scope|"Randomly allocated to fibreoptic group~Flexible fibreoptic scope: Patient intubated using fibreoptic scope"
15105|NCT02614586|B1|Baseline|Part-1: Screening Phase|Participants received 2 P50 electroencephalography (EEG) sessions, first session was conducted in the morning, and second session was conducted in the afternoon. Participants did not receive any study medication in Screening Phase (Part-1) of the study.
15021|NCT02615990|P1|Participant Flow|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
15022|NCT02615990|O2|Outcome|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
15023|NCT02615990|O1|Outcome|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
15024|NCT02615990|O2|Outcome|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
15025|NCT02615990|O1|Outcome|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
15026|NCT02615990|O2|Outcome|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
15027|NCT02615990|O1|Outcome|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
15028|NCT02615990|O2|Outcome|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
15029|NCT02615990|O1|Outcome|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
15030|NCT02615990|O2|Outcome|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
15031|NCT02615990|O1|Outcome|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
15032|NCT02615990|O2|Outcome|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
15033|NCT02615990|O1|Outcome|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
15034|NCT02615990|O2|Outcome|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
15035|NCT02615990|O1|Outcome|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
15036|NCT02615990|O2|Outcome|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
15321|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15322|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15037|NCT02615990|O1|Outcome|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
15038|NCT02615990|O2|Outcome|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
15039|NCT02615990|O1|Outcome|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
15040|NCT02615990|O2|Outcome|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
15041|NCT02615990|O1|Outcome|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
15042|NCT02615990|O2|Outcome|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
15043|NCT02615990|O1|Outcome|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
15044|NCT02615990|O2|Outcome|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
15045|NCT02615990|O1|Outcome|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
15046|NCT02615990|O2|Outcome|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
15047|NCT02615990|O1|Outcome|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
15048|NCT02615990|O2|Outcome|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
15049|NCT02615990|O1|Outcome|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
15050|NCT02615990|O2|Outcome|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
15051|NCT02615990|O1|Outcome|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
15052|NCT02615990|O2|Outcome|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
15106|NCT02614586|P1|Participant Flow|Part-1: Screening Phase|Participants received 2 P50 electroencephalography (EEG) sessions, first session was conducted in the morning, and second session was conducted in the afternoon. Participants did not receive any study medication in Screening Phase (Part-1) of the study.
15053|NCT02615990|O1|Outcome|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
15054|NCT02615990|O2|Outcome|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
15055|NCT02615990|O1|Outcome|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
15056|NCT02615990|O2|Outcome|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
15057|NCT02615990|O1|Outcome|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
15058|NCT02615990|O2|Outcome|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
15059|NCT02615990|O1|Outcome|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
15060|NCT02615990|O2|Outcome|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
15061|NCT02615990|O1|Outcome|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
15062|NCT02615990|E2|Reported Event|Standard Physical Therapy|"Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Standard Physical Therapy: Patients receive standard physical therapy."
15063|NCT02615990|E1|Reported Event|Erigo Pro Plus Standard Physical Therapy|"The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.~Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading"
15064|NCT02615743|B3|Baseline|Total|Total of all reporting groups
15065|NCT02615743|B2|Baseline|Control Group|"Caregivers of control arm participants will receive an electronic monitoring device to track their medication usage for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.~An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. Subjects will not receive daily text messages.The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem."
15066|NCT02615743|B1|Baseline|Intervention Group|"Caregivers of intervention participants will receive daily text message reminders about asthma controller medication use and an electronic monitoring device to track their medication use for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.~The text message will remind them to give their child their controller medication and provide a helpful information on asthma controller use.~An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem."
15141|NCT02614222|B3|Baseline|Total|Total of all reporting groups
15142|NCT02614222|B2|Baseline|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
15323|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15067|NCT02615743|P2|Participant Flow|Control Group|"Caregivers of control arm participants will receive an electronic monitoring device to track their medication usage for 60 days following hospital discharge. All participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.~An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. Subjects will not receive daily text messages.The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem."
15068|NCT02615743|P1|Participant Flow|Intervention Group|"Caregivers of Intervention arm participants will receive daily text message reminders about asthma controller medication use, as well as an electronic monitoring device to track their medication usage for 60 days following hospital discharge. All participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.~The text message will remind them to give their child their controller medication and provide a helpful information on asthma controller use.~An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem."
15069|NCT02615743|O2|Outcome|Control Group|"Caregivers of control arm participants will receive an electronic monitoring device to track their medication usage for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.~An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. Subjects will not receive daily text messages.The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem."
15070|NCT02615743|O1|Outcome|Intervention Group|"Caregivers of intervention participants will receive daily text message reminders about asthma controller medication use and an electronic monitoring device to track their medication use for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.~The text message will remind them to give their child their controller medication and provide a helpful information on asthma controller use.~An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem."
15071|NCT02615743|O2|Outcome|Control Group|"Caregivers of control arm participants will receive an electronic monitoring device to track their medication usage for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.~An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. Subjects will not receive daily text messages.The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem."
15072|NCT02615743|O1|Outcome|Intervention Group|"Caregivers of intervention participants will receive daily text message reminders about asthma controller medication use and an electronic monitoring device to track their medication use for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.~The text message will remind them to give their child their controller medication and provide a helpful information on asthma controller use.~An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem."
15073|NCT02615743|O2|Outcome|Control Group|"Caregivers of control arm participants will receive an electronic monitoring device to track their medication usage for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.~An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. Subjects will not receive daily text messages.The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem."
15074|NCT02615743|O1|Outcome|Intervention Group|"Caregivers of intervention participants will receive daily text message reminders about asthma controller medication use and an electronic monitoring device to track their medication use for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.~The text message will remind them to give their child their controller medication and provide a helpful information on asthma controller use.~An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem."
15324|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15075|NCT02615743|O2|Outcome|Control Group|"Caregivers of control arm participants will receive an electronic monitoring device to track their medication usage for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.~An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. Subjects will not receive daily text messages.The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem."
15076|NCT02615743|O1|Outcome|Intervention Group|"Caregivers of intervention participants will receive daily text message reminders about asthma controller medication use and an electronic monitoring device to track their medication use for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.~The text message will remind them to give their child their controller medication and provide a helpful information on asthma controller use.~An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem."
15077|NCT02615743|E2|Reported Event|Control Group|"Caregivers of control arm participants will receive an electronic monitoring device to track their medication usage for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.~An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. Subjects will not receive daily text messages.The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem."
15078|NCT02615743|E1|Reported Event|Intervention Group|"Caregivers of intervention participants will receive daily text message reminders about asthma controller medication use and an electronic monitoring device to track their medication use for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.~The text message will remind them to give their child their controller medication and provide a helpful information on asthma controller use.~An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem."
15079|NCT02615717|B3|Baseline|Total|Total of all reporting groups
15080|NCT02615717|B2|Baseline|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.~Attention Bias Modification: comparison of treatment versus control"
15081|NCT02615717|B1|Baseline|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).~Attention Bias Modification: comparison of treatment versus control"
15082|NCT02615717|P2|Participant Flow|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.~Attention Bias Modification: comparison of treatment versus control"
15083|NCT02615717|P1|Participant Flow|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).~Attention Bias Modification: comparison of treatment versus control"
15084|NCT02615717|O2|Outcome|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.~Attention Bias Modification: comparison of treatment versus control"
15243|NCT02613403|O3|Outcome|[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
15085|NCT02615717|O1|Outcome|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).~Attention Bias Modification: comparison of treatment versus control"
15086|NCT02615717|O2|Outcome|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.~Attention Bias Modification: comparison of treatment versus control"
15087|NCT02615717|O1|Outcome|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).~Attention Bias Modification: comparison of treatment versus control"
15088|NCT02615717|O2|Outcome|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.~Attention Bias Modification: comparison of treatment versus control"
15089|NCT02615717|O1|Outcome|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).~Attention Bias Modification: comparison of treatment versus control"
15090|NCT02615717|O2|Outcome|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.~Attention Bias Modification: comparison of treatment versus control"
15091|NCT02615717|O1|Outcome|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).~Attention Bias Modification: comparison of treatment versus control"
15092|NCT02615717|E2|Reported Event|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.~Attention Bias Modification: comparison of treatment versus control"
15093|NCT02615717|E1|Reported Event|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).~Attention Bias Modification: comparison of treatment versus control"
15094|NCT02614924|B3|Baseline|Total|Total of all reporting groups
15095|NCT02614924|B2|Baseline|Pentax AWS Videolaryngoscope Group|Randomly allocated Pentax AWS videolaryngoscope and intubated using Pentax AWS videolaryngoscope
15096|NCT02614924|B1|Baseline|Flexible Fibre-optic Scope|"Randomly allocated to fibreoptic group~Flexible fibreoptic scope: Patient intubated using fibreoptic scope"
15097|NCT02614924|P2|Participant Flow|Pentax AWS Videolaryngoscope|Randomly allocated to Pentax AWS
15098|NCT02614924|P1|Participant Flow|Flexible Fibre-optic Scope|"Randomly allocated to fibreoptic group~Flexible fibreoptic scope: Patient intubated using fibreoptic scope"
15099|NCT02614924|O2|Outcome|Pentax AWS Videolaryngoscope|Randomly allocated to Pentax AWS
15100|NCT02614924|O1|Outcome|Flexible Fibre-optic Scope|"Randomly allocated to fibreoptic group~Flexible fibreoptic scope: Patient intubated using fibreoptic scope"
15101|NCT02614924|O2|Outcome|Pentax AWS Videolaryngoscope|randomly allocated to Pentax AWs
15102|NCT02614924|O1|Outcome|Flexible Fibre-optic Scope|"Randomly allocated to fibreoptic group~Flexible fibreoptic scope: Patient intubated using fibreoptic scope"
15703|NCT02609113|O2|Outcome|Weaker Magnetic Wristband|"Magnetic wristband of 5 Gauss strength.~Weaker Magnetic Wristband"
15107|NCT02614586|O1|Outcome|Part 2: TAK-058 and Ondansetron|In Treatment Phase (Part 2) of the study, participants were planned to be randomized into 3-period cross-over treatment phase with single oral dose of 1 of the 3 regimens in each period: TAK-058, ondansetron, and placebo. Participants were planned to receive treatment in following 6 sequences: placebo, TAK-058, and ondansetron; TAK-058, placebo, and ondansetron; ondansetron, placebo, and TAK-058; placebo, ondansetron, and TAK-058; TAK-058, ondansetron, and placebo; and ondansetron, TAK-058, and placebo in intervention period 1, 2, and 3 respectively. A washout period of at least 7 days was planned to be maintained between each intervention period.
15108|NCT02614586|O1|Outcome|Part 2: TAK-058 and Ondansetron|In Treatment Phase (Part 2) of the study, participants were planned to be randomized into 3-period cross-over treatment phase with single oral dose of 1 of the 3 regimens in each period: TAK-058, ondansetron, and placebo. Participants were planned to receive treatment in following 6 sequences: placebo, TAK-058, and ondansetron; TAK-058, placebo, and ondansetron; ondansetron, placebo, and TAK-058; placebo, ondansetron, and TAK-058; TAK-058, ondansetron, and placebo; and ondansetron, TAK-058, and placebo in intervention period 1, 2, and 3 respectively. A washout period of at least 7 days was planned to be maintained between each intervention period.
15109|NCT02614586|E1|Reported Event|Part 2: TAK-058 and Ondansetron|In Treatment Phase (Part 2) of the study, participants were planned to be randomized into 3-period cross-over treatment phase with single oral dose of 1 of the 3 regimens in each period: TAK-058, ondansetron, and placebo. Participants were planned to receive treatment in following 6 sequences: placebo, TAK-058, and ondansetron; TAK-058, placebo, and ondansetron; ondansetron, placebo, and TAK-058; placebo, ondansetron, and TAK-058; TAK-058, ondansetron, and placebo; and ondansetron, TAK-058, and placebo in intervention period 1, 2, and 3 respectively. A washout period of at least 7 days was planned to be maintained between each intervention period.
15110|NCT02614469|B3|Baseline|Total|Total of all reporting groups
15111|NCT02614469|B2|Baseline|Group 2, Inosine Without Food Then With Food|"Group 2 subjects will take inosine without food on day 1 after an overnight fast and will take a second dose of inosine with food on day 8 after an overnight fast.~Inosine: Inosine, 1000 mg"
15112|NCT02614469|B1|Baseline|Group 1, Inosine With Food Then Without Food|"Group 1 subjects will take inosine with food on day 1 after an overnight fast and will take a second dose of inosine without food on day 8 after an overnight fast.~Inosine: Inosine, 1000 mg"
15113|NCT02614469|P2|Participant Flow|Group 2, Inosine Without Food Then With Food|"Group 2 subjects will take inosine without food on day 1 after an overnight fast and after a 7 day washout, will take a second dose of inosine with food on day 8 after an overnight fast.~Inosine: Inosine, 1000 mg"
15114|NCT02614469|P1|Participant Flow|Group 1, Inosine With Food Then Without Food|"Group 1 subjects will take inosine with food on day 1 after an overnight fast and after a 7 day washout, will take a second dose of inosine without food on day 8 after an overnight fast.~Inosine: Inosine, 1000 mg"
15115|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
15116|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
15117|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
15118|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
15119|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
15120|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
15121|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
15122|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
15123|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
15124|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
15125|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
15126|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
15127|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
15128|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
15129|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
15130|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
15131|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
15132|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
15133|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
15134|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
15135|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
15136|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
15137|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
15138|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
15139|NCT02614469|E2|Reported Event|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
15140|NCT02614469|E1|Reported Event|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
15143|NCT02614222|B1|Baseline|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
15144|NCT02614222|P2|Participant Flow|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
15145|NCT02614222|P1|Participant Flow|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
15146|NCT02614222|O2|Outcome|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
15147|NCT02614222|O1|Outcome|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
15148|NCT02614222|O2|Outcome|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
15149|NCT02614222|O1|Outcome|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
15150|NCT02614222|O2|Outcome|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
15151|NCT02614222|O1|Outcome|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
15152|NCT02614222|O2|Outcome|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
15153|NCT02614222|O1|Outcome|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
15154|NCT02614222|O2|Outcome|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
15155|NCT02614222|O1|Outcome|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
15156|NCT02614222|O2|Outcome|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
15157|NCT02614222|O1|Outcome|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
15158|NCT02614222|O2|Outcome|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
15159|NCT02614222|O1|Outcome|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
15160|NCT02614222|O2|Outcome|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
15161|NCT02614222|O1|Outcome|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
15162|NCT02614222|E2|Reported Event|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
15163|NCT02614222|E1|Reported Event|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
15164|NCT02614079|B1|Baseline|DSSEP|"DSSEP testing after SCS trial lead placement~DSSEP: Collision testing after the placement of SCS leads"
15165|NCT02614079|P1|Participant Flow|DSSEP - Dermatomal Somato Sensory Evoked Potentials|"DSSEP testing after SCS trial lead placement~DSSEP: Collision testing after the placement of SCS leads"
15166|NCT02614079|O1|Outcome|DSSEP|"DSSEP testing after SCS trial lead placement~DSSEP: Collision testing after the placement of SCS leads"
15167|NCT02614079|E1|Reported Event|DSSEP|"DSSEP testing after SCS trial lead placement~DSSEP: Collision testing after the placement of SCS leads"
15168|NCT02613910|B1|Baseline|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15169|NCT02613910|P1|Participant Flow|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15170|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15171|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15172|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15173|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15174|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15244|NCT02613403|O2|Outcome|[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
15175|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15176|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15177|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15178|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15179|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15180|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15181|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15182|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15245|NCT02613403|O1|Outcome|[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
15246|NCT02613403|O4|Outcome|[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
15183|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15184|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15185|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15186|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15187|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15188|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15189|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15190|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15247|NCT02613403|O3|Outcome|[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
15248|NCT02613403|O2|Outcome|[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
15191|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15192|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15193|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15194|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15195|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15196|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15197|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15198|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15249|NCT02613403|O1|Outcome|[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
15250|NCT02613403|O4|Outcome|[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
15199|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15200|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15201|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15202|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15203|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15204|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15205|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15206|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15251|NCT02613403|O3|Outcome|[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
15252|NCT02613403|O2|Outcome|[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
15207|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15208|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15209|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15210|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15211|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15212|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15213|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15214|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15253|NCT02613403|O1|Outcome|[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
15254|NCT02613403|O4|Outcome|[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
15215|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15216|NCT02613910|E1|Reported Event|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
15217|NCT02613871|B1|Baseline|LDV/SOF FDC|LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
15218|NCT02613871|P1|Participant Flow|LDV/SOF FDC|Ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) 90/400 mg tablet administered orally once daily for 12 weeks
15219|NCT02613871|O1|Outcome|LDV/SOF FDC|LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
15220|NCT02613871|O1|Outcome|LDV/SOF FDC|LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
15221|NCT02613871|O1|Outcome|LDV/SOF FDC|LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
15222|NCT02613871|O1|Outcome|LDV/SOF FDC|LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
15223|NCT02613871|O1|Outcome|LDV/SOF FDC|LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
15224|NCT02613871|O1|Outcome|LDV/SOF FDC|LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
15225|NCT02613871|O1|Outcome|LDV/SOF FDC|LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
15226|NCT02613871|O1|Outcome|LDV/SOF FDC|LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
15227|NCT02613871|O1|Outcome|LDV/SOF FDC|LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
15228|NCT02613871|O1|Outcome|LDV/SOF FDC|LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
15229|NCT02613871|O1|Outcome|LDV/SOF FDC|LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
15230|NCT02613871|O1|Outcome|LDV/SOF FDC|LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
15231|NCT02613871|E1|Reported Event|LDV/SOF FDC|LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
15232|NCT02613403|B5|Baseline|Total|Total of all reporting groups
15233|NCT02613403|B4|Baseline|[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
15234|NCT02613403|B3|Baseline|[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
15235|NCT02613403|B2|Baseline|[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
15236|NCT02613403|B1|Baseline|[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
15237|NCT02613403|P5|Participant Flow|[Part B] Prior DAA (GT1-6) or SOF/PR (GT3) Failure: MK-3682B|C or NC HCV participants previously failing any all-oral DAA regimen (GT1-6) or SOF/pegylated interferon and ribavirin (PR) regimen (GT 3 only) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 16 weeks.
15238|NCT02613403|P4|Participant Flow|[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
15239|NCT02613403|P3|Participant Flow|[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/elbasvir (EBR) (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
15240|NCT02613403|P2|Participant Flow|[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
15241|NCT02613403|P1|Participant Flow|[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of sofosbuvir (SOF)/ledipasvir (LDV) receive MK-3682B, a fixed dose combination (FDC) of grazoprevir (GZR; MK-5172 [50 mg]) + uprifosbuvir (UPR; MK-3682 [225 mg]) + ruzasvir (RZR; MK-8408 [30 mg]), administered as 2 tablets once daily in combination with ribavirin (RBV) twice daily for 16 weeks.
15242|NCT02613403|O4|Outcome|[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
15704|NCT02609113|O1|Outcome|Strong Magnetic Wristband|"Magnetic wristband of 1,795 Gauss strength~Strong Magnetic Wristband"
15255|NCT02613403|O3|Outcome|[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
15256|NCT02613403|O2|Outcome|[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
15257|NCT02613403|O1|Outcome|[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
15258|NCT02613403|O4|Outcome|[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
15259|NCT02613403|O3|Outcome|[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
15260|NCT02613403|O2|Outcome|[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
15261|NCT02613403|O1|Outcome|[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
15262|NCT02613403|O4|Outcome|[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
15263|NCT02613403|O3|Outcome|[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
15264|NCT02613403|O2|Outcome|[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
15265|NCT02613403|O1|Outcome|[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
15266|NCT02613403|O4|Outcome|[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
15267|NCT02613403|O3|Outcome|[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
15268|NCT02613403|O2|Outcome|[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
15269|NCT02613403|O1|Outcome|[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
15270|NCT02613403|O4|Outcome|[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
15271|NCT02613403|O3|Outcome|[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
15272|NCT02613403|O2|Outcome|[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
15273|NCT02613403|O1|Outcome|[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
15274|NCT02613403|O4|Outcome|[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
15275|NCT02613403|O3|Outcome|[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
15276|NCT02613403|O2|Outcome|[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
20082|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
15277|NCT02613403|O1|Outcome|[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
15278|NCT02613403|E4|Reported Event|[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
15279|NCT02613403|E3|Reported Event|[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
15280|NCT02613403|E2|Reported Event|[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
15281|NCT02613403|E1|Reported Event|[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
15282|NCT02612610|B5|Baseline|Total|Total of all reporting groups
15283|NCT02612610|B4|Baseline|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15284|NCT02612610|B3|Baseline|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15285|NCT02612610|B2|Baseline|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15286|NCT02612610|B1|Baseline|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15287|NCT02612610|P4|Participant Flow|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15288|NCT02612610|P3|Participant Flow|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15289|NCT02612610|P2|Participant Flow|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15290|NCT02612610|P1|Participant Flow|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15291|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15292|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15293|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15294|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15295|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15296|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15297|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15298|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15299|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15300|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15301|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15302|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15303|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15304|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15305|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15306|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15307|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15308|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15309|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15310|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15311|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15312|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15313|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15314|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15315|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15316|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15317|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15318|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15325|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15326|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15327|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15328|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15329|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15330|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15331|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15332|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15333|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15334|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15335|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15336|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15337|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15338|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15339|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15340|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15341|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15342|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15343|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15344|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15345|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15346|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15347|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15348|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15349|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15350|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15351|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15352|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15353|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15354|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15355|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15356|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15357|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15358|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15359|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15360|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15361|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15362|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15363|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15364|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15365|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15366|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15367|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15368|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15369|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15370|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15371|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15372|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15373|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15374|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15375|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15376|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15377|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15378|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15379|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15380|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15381|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15382|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15383|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15384|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15385|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15386|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15387|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15388|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15389|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15390|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15391|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15392|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15393|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15394|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15395|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15396|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15397|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15398|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15399|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15400|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15401|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15402|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15403|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15404|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15405|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15406|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15407|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15408|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15409|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15410|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15411|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15412|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15413|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15414|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15415|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15416|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15417|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15418|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15419|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15420|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15421|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15422|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15423|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15424|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15425|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15426|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15427|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15428|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15429|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15430|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15431|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15432|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15433|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15434|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15435|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15436|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15437|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15438|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15439|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15440|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15441|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15442|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15443|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15444|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15445|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15446|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15447|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15448|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15449|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15450|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15451|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15452|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15453|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15454|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15455|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15456|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15457|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15458|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15459|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15460|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15461|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15462|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15463|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15464|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15465|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15466|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15467|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15468|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15469|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15470|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15471|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15472|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15473|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15474|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15475|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15476|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15477|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15478|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15479|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15480|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15481|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15482|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15483|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15484|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15485|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15486|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15487|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15488|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15489|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15490|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15491|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15492|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15493|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15494|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15495|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15496|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15497|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15498|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15499|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15500|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15501|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15502|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15503|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15504|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15505|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15506|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15507|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15508|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15509|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15510|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15511|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15512|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15513|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15514|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15515|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15516|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15517|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15518|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15519|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15520|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15521|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15522|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15523|NCT02612610|O4|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15524|NCT02612610|O3|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15525|NCT02612610|O2|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15526|NCT02612610|O1|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15527|NCT02612610|E4|Reported Event|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15528|NCT02612610|E3|Reported Event|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15529|NCT02612610|E2|Reported Event|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
15530|NCT02612610|E1|Reported Event|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
15531|NCT02612077|B1|Baseline|Observational Chemotherapy/Bevacizumab|Observed patients receiving chemotherapy with concomitant bevacizumab
15532|NCT02612077|P1|Participant Flow|Observational Chemotherapy/Bevacizumab|Observed patients receiving chemotherapy with concomitant bevacizumab
15533|NCT02612077|O1|Outcome|Observational Chemotherapy/Bevacizumab|Observed patients receiving chemotherapy with concomitant bevacizumab
15534|NCT02612077|O3|Outcome|Bevacizumab With 3rd Line Treatment|Patients treated with bevacizumab during third line treatment of chemotherapy
15535|NCT02612077|O2|Outcome|Bevacizumab With 2nd Line Treatment|Patients treated with bevacizumab during second line treatment of chemotherapy
15536|NCT02612077|O1|Outcome|Bevacizumab With 1st Line Treatment|Patients treated with bevacizumab during first line treatment of chemotherapy
15537|NCT02612077|O3|Outcome|Bevacizumab With 3rd Line Treatment|Patients treated with bevacizumab during third line treatment of chemotherapy
15538|NCT02612077|O2|Outcome|Bevacizumab With 2nd Line Treatment|Patients treated with bevacizumab during second line treatment of chemotherapy
15539|NCT02612077|O1|Outcome|Bevacizumab With 1st Line Treatment|Patients treated with bevacizumab during first line treatment of chemotherapy
15540|NCT02612077|E1|Reported Event|Observational Chemotherapy/Bevacizumab|Observed patients receiving chemotherapy with concomitant bevacizumab
15541|NCT02612064|B3|Baseline|Total|Total of all reporting groups
15542|NCT02612064|B2|Baseline|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
15543|NCT02612064|B1|Baseline|Stannous Fluoride|Test: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
15544|NCT02612064|P2|Participant Flow|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
15545|NCT02612064|P1|Participant Flow|Stannous Fluoride|Test: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
15546|NCT02612064|O2|Outcome|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
15547|NCT02612064|O1|Outcome|Stannous Fluoride|Test: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
15574|NCT02611154|O7|Outcome|Urine Steroid Profile - Day 35|Urine was collected at Day 35 to identify any suppression of endogenous testosterone production following administration.
15548|NCT02612064|O2|Outcome|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
15549|NCT02612064|O1|Outcome|Stannous Fluoride|Test: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
15550|NCT02612064|O2|Outcome|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
15551|NCT02612064|O1|Outcome|Stannous Fluoride|Test: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
15552|NCT02612064|E2|Reported Event|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
15553|NCT02612064|E1|Reported Event|Stannous Fluoride|Test: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
15554|NCT02611765|B3|Baseline|Total|Total of all reporting groups
15555|NCT02611765|B2|Baseline|Standard Therapy|"A single intramuscular injection of 2.4 million units of benzathine penicillin G~Standard therapy: A single dose of intramuscular 2.4 million units of benzathine penicillin G"
15556|NCT02611765|B1|Baseline|Enhanced Therapy|"Three doses of 2.4 million units of intramuscular benzathine penicillin G administered weekly (a total of 7.2 million units)~Enhanced therapy: Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units)."
15557|NCT02611765|P2|Participant Flow|Standard Therapy|"A single intramuscular injection of 2.4 million units of benzathine penicillin G~Standard therapy: A single dose of intramuscular 2.4 million units of benzathine penicillin G"
15558|NCT02611765|P1|Participant Flow|Enhanced Therapy|"Three doses of 2.4 million units of intramuscular benzathine penicillin G administered weekly (a total of 7.2 million units)~Enhanced therapy: Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units)."
15559|NCT02611765|O2|Outcome|Standard Therapy|"A single intramuscular injection of 2.4 million units of benzathine penicillin G~Standard therapy: A single dose of intramuscular 2.4 million units of benzathine penicillin G"
15560|NCT02611765|O1|Outcome|Enhanced Therapy|"Three doses of 2.4 million units of intramuscular benzathine penicillin G administered weekly (a total of 7.2 million units)~Enhanced therapy: Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units)."
15561|NCT02611765|E2|Reported Event|Standard Therapy|"A single intramuscular injection of 2.4 million units of benzathine penicillin G~Standard therapy: A single dose of intramuscular 2.4 million units of benzathine penicillin G"
15562|NCT02611765|E1|Reported Event|Enhanced Therapy|"Three doses of 2.4 million units of intramuscular benzathine penicillin G administered weekly (a total of 7.2 million units)~Enhanced therapy: Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units)."
15563|NCT02611154|B1|Baseline|Intranasal Testosterone|"All participants will be receiving intranasal testosterone and will follow the same study procedures.~Testosterone: Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks."
15564|NCT02611154|P1|Participant Flow|Intranasal Testosterone|"All participants will be receiving intranasal testosterone and will follow the same study procedures.~Testosterone: Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks."
15565|NCT02611154|O2|Outcome|Serum Testosterone - Day 19|Serum Testosterone at Day 19
15566|NCT02611154|O1|Outcome|Serum Testosterone - Day 0|Serum Testosterone at Day 0
15567|NCT02611154|O6|Outcome|5βAdiol|5βAdiol level will be measured in the urine sample.
15568|NCT02611154|O5|Outcome|5αAdiol|5αAdiol level will be measured in the urine sample.
15569|NCT02611154|O4|Outcome|Etiocholanolone|Etiocholanolone level will be measured in the urine sample.
15570|NCT02611154|O3|Outcome|Androsterone|Androsterone level will be measured in the urine sample.
15571|NCT02611154|O2|Outcome|Epitestosterone|Epitestosterone level will be measured in the urine sample.
15572|NCT02611154|O1|Outcome|Testosterone|Testosterone level will be measured in the urine sample.
15573|NCT02611154|O8|Outcome|Urine Steroid Profile - Day 42|Urine was collected at Day 42 to identify any suppression of endogenous testosterone production following administration.
20083|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
15575|NCT02611154|O6|Outcome|Urine Steroid Profile - Day 30|Day 30 steroid level in urine. Urine sample analyzed within the 48-72 hour window post-administration.
15576|NCT02611154|O5|Outcome|Urine Steroid Profile - Day 29|Day 29 steroid level in urine. Urine sample analyzed within the 24-48 hour window post-administration.
15577|NCT02611154|O4|Outcome|Urine Steroid Profile - Day 28|Day 28 steroid level in urine. Urine sample analyzed within 24 hours of dosing.
15578|NCT02611154|O3|Outcome|Urine Steroid Profile - Day 21|Day 21 steroid level in urine. Urine sample analyzed within 24 hours of dosing.
15579|NCT02611154|O2|Outcome|Urine Steroid Profile - Day 13|Day 13 steroid level in urine. Urine sample analyzed within 24 hours of dosing.
15580|NCT02611154|O1|Outcome|Urine Steroid Profile - Day 6|Day 6 steroid level in urine. Urine sample analyzed within 24 hours of dosing.
15581|NCT02611154|E1|Reported Event|Intranasal Testosterone|"All participants will be receiving intranasal testosterone and will follow the same study procedures.~Testosterone: Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks."
15582|NCT02610634|B3|Baseline|Total|Total of all reporting groups
15583|NCT02610634|B2|Baseline|Older Adults|Aged-matched older adults (≥ 50 years old) who are cognitively intact (MoCA ≥26).
15584|NCT02610634|B1|Baseline|Parkinson's Disease|People with Parkinson's disease (≥ 50 years old) who do not have dementia (MoCA ≥ 21).
15585|NCT02610634|P2|Participant Flow|Older Adults|Aged-matched older adults (≥ 50 years old) who are cognitively intact (MoCA ≥26).
15586|NCT02610634|P1|Participant Flow|Parkinson's Disease|People with Parkinson's disease (≥ 50 years old) who do not have dementia (MoCA ≥ 21).
15587|NCT02610634|O2|Outcome|Older Adults|Aged-matched older adults (≥ 50 years old) who are cognitively intact (MoCA ≥26).
15588|NCT02610634|O1|Outcome|Parkinson's Disease|People with Parkinson's disease (≥ 50 years old) who do not have dementia (MoCA ≥ 21).
15589|NCT02610634|E2|Reported Event|Older Adults|Aged-matched older adults (≥ 50 years old) who are cognitively intact (MoCA ≥26).
15590|NCT02610634|E1|Reported Event|Parkinson's Disease|People with Parkinson's disease (≥ 50 years old) who do not have dementia (MoCA ≥ 21).
15591|NCT02609841|B3|Baseline|Total|Total of all reporting groups
15592|NCT02609841|B2|Baseline|≥3K Dialysate Patients|Patients on ≥3K dialysate who received all 6 hemodialysis treatments over 12 days
15593|NCT02609841|B1|Baseline|<3 K Dialysate Patients|Patients on <3 K dialysate and received all 6 hemodialysis treatments over 12 days.
15594|NCT02609841|P1|Participant Flow|Enrolled Study Population|All patients who were enrolled in the study
15595|NCT02609841|O1|Outcome|Completed the Study and Wore the Body Guardian|All subjects (<3 K dialysate or dialysate combined) who received all 6 hemodialysis treatments over 12 days and wore the Body Guardian device
15596|NCT02609841|O1|Outcome|≥3 K Dialysate Patients|Subjects on ≥3 K dialysate and received all 6 hemodialysis treatments over 12 days.
15597|NCT02609841|O1|Outcome|<3 K Dialysate Patients|Subjects on <3 K dialysate and received all 6 hemodialysis treatments over 12 days.
15598|NCT02609841|E1|Reported Event|Cardiac Rhythm Monitoring System|Subjects use non-invasive wearable BodyGuardian remote monitoring system throughout 12 days of study.
15599|NCT02609672|B3|Baseline|Total|Total of all reporting groups
15600|NCT02609672|B2|Baseline|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15601|NCT02609672|B1|Baseline|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15602|NCT02609672|P2|Participant Flow|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee osteoarthritis, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15603|NCT02609672|P1|Participant Flow|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15654|NCT02609633|O2|Outcome|Interventional: Accu-Chek® CONNECT DMS|Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
15655|NCT02609633|O1|Outcome|Control: Usual Care - Current Diabetes Management System (DMS)|Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
15604|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15605|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15606|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15607|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15608|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15609|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15610|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15611|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15612|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15656|NCT02609633|O2|Outcome|Interventional: Accu-Chek® CONNECT DMS|Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
15657|NCT02609633|O1|Outcome|Control: Usual Care - Current Diabetes Management System (DMS)|Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
20084|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
15613|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15614|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15615|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15616|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15617|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15618|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15619|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15620|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15621|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15658|NCT02609633|O2|Outcome|Interventional: Accu-Chek® CONNECT DMS|Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
15659|NCT02609633|O1|Outcome|Control: Usual Care - Current Diabetes Management System (DMS)|Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
15660|NCT02609633|O2|Outcome|Interventional: Accu-Chek® CONNECT DMS|Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
15622|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15623|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15624|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15625|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15626|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15627|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15628|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15629|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15630|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15661|NCT02609633|O1|Outcome|Control: Usual Care - Current Diabetes Management System (DMS)|Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
15662|NCT02609633|O2|Outcome|Interventional: Accu-Chek® CONNECT DMS|Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
20085|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
15631|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15632|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15633|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15634|NCT02609672|E2|Reported Event|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15635|NCT02609672|E1|Reported Event|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
15636|NCT02609659|B1|Baseline|3-DAA + RBV 600 mg|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) plus RBV (ribavirin [600 mg once daily]) for 12 weeks.
15637|NCT02609659|P1|Participant Flow|3-DAA + RBV 600 mg|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) plus RBV (ribavirin [600 mg once daily]) for 12 weeks.
15638|NCT02609659|O1|Outcome|3-DAA + RBV 600 mg|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) plus RBV (ribavirin [600 mg once daily]) for 12 weeks.
15639|NCT02609659|O1|Outcome|3-DAA + RBV 600 mg|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) plus RBV (ribavirin [600 mg once daily]) for 12 weeks.
15640|NCT02609659|O1|Outcome|3-DAA + RBV 600 mg|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) plus RBV (ribavirin [600 mg once daily]) for 12 weeks.
15641|NCT02609659|O1|Outcome|3-DAA + RBV 600 mg|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) plus RBV (ribavirin [600 mg once daily]) for 12 weeks.
15642|NCT02609659|O1|Outcome|3-DAA + RBV 600 mg|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) plus RBV (ribavirin [600 mg once daily]) for 12 weeks.
15643|NCT02609659|E1|Reported Event|3-DAA + RBV 600 mg|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) plus RBV (ribavirin [600 mg once daily]) for 12 weeks.
15644|NCT02609633|B3|Baseline|Total|Total of all reporting groups
15645|NCT02609633|B2|Baseline|Interventional: Accu-Chek® CONNECT DMS|Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
15646|NCT02609633|B1|Baseline|Control: Usual Care - Current Diabetes Management System (DMS)|Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
15647|NCT02609633|P2|Participant Flow|Interventional: Accu-Chek® CONNECT DMS|Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
15648|NCT02609633|P1|Participant Flow|Control: Usual Care - Current Diabetes Management System (DMS)|Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
15649|NCT02609633|O1|Outcome|Interventional: Accu-Chek® CONNECT DMS|Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
15650|NCT02609633|O1|Outcome|Interventional: Accu-Chek® CONNECT DMS|Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
15651|NCT02609633|O1|Outcome|Interventional: Accu-Chek® CONNECT DMS|Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
15652|NCT02609633|O2|Outcome|Interventional: Accu-Chek® CONNECT DMS|Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
15653|NCT02609633|O1|Outcome|Control: Usual Care - Current Diabetes Management System (DMS)|Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
15663|NCT02609633|O1|Outcome|Control: Usual Care - Current Diabetes Management System (DMS)|Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
15664|NCT02609633|O2|Outcome|Interventional: Accu-Chek® CONNECT DMS|Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
15665|NCT02609633|O1|Outcome|Control: Usual Care - Current Diabetes Management System (DMS)|Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
15666|NCT02609633|O2|Outcome|Interventional: Accu-Chek® CONNECT DMS|Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
15667|NCT02609633|O1|Outcome|Control: Usual Care - Current Diabetes Management System (DMS)|Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
15668|NCT02609633|O2|Outcome|Interventional: Accu-Chek® CONNECT DMS|Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
15669|NCT02609633|O1|Outcome|Control: Usual Care - Current Diabetes Management System (DMS)|Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
15670|NCT02609633|E2|Reported Event|Interventional: Accu-Chek® CONNECT DMS|Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
15671|NCT02609633|E1|Reported Event|Control: Usual Care - Current Diabetes Management System (DMS)|Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
15672|NCT02609178|B1|Baseline|Occlusal Surface Design|use computer-aided design and computer-aided manufacturing technique (CAD/CAM) to execute different occlusal surface designs of the artificial crown, including FGP design (FGP and AVR) and conventional design (CON), and evaluate their efficacy, separately
15673|NCT02609178|P6|Participant Flow|CON First, Then AVR, Then FGP|Tried in the artificial crowns for the same participant as the following sequence: CON, AVR, FGP, a 5-min washout period would be given between each crown.
15674|NCT02609178|P5|Participant Flow|CON First, Then FGP, Then AVR|Tried in the artificial crowns for the same participant as the following sequence: CON, FGP, AVR, a 5-min washout period would be given between each crown.
15675|NCT02609178|P4|Participant Flow|AVR First, Then CON, Then FGP|Tried in the artificial crowns for the same participant as the following sequence: AVR, CON, FGP, a 5-min washout period would be given between each crown.
15676|NCT02609178|P3|Participant Flow|AVR First, Then FGP, Then CON|Tried in the artificial crowns for the same participant as the following sequence: AVR, FGP, CON, a 5-min washout period would be given between each crown.
15677|NCT02609178|P2|Participant Flow|FGP First, Then CON, Then AVR|Tried in the artificial crowns for the same participant as the following sequence: FGP, CON, AVR, a 5-min washout period would be given between each crown.
15678|NCT02609178|P1|Participant Flow|FGP First, Then AVR, Then CON|Tried in the artificial crowns for the same participant as the following sequence: FGP, AVR, CON, a 5-min washout period would be given between each crown.
15679|NCT02609178|O3|Outcome|CON Designed Surface|The occlusal surface of the artificial crown was fabricated based on the technicians' experience.
15680|NCT02609178|O2|Outcome|AVR Designed Surface|The occlusal surface of the artificial crown was designed by setting the virtual articulator at average values, that is, 30° for the angles of the sagittal condyle and 15° for the lateral Bennett angle, and 30° for the incisal path, respectively.
15681|NCT02609178|O1|Outcome|FGP Designed Surface|The occlusal surface of the artificial crown was designed by FGP technique.
15682|NCT02609178|O3|Outcome|CON Designed Surface|The occlusal surface of the artificial crown was fabricated based on the technicians' experience.
15683|NCT02609178|O2|Outcome|AVR Designed Surface|The occlusal surface of the artificial crown was designed by setting the virtual articulator at average values, that is, 30° for the angles of the sagittal condyle and 15° for the lateral Bennett angle, and 30° for the incisal path, respectively.
15684|NCT02609178|O1|Outcome|FGP Designed Surface|The occlusal surface of the artificial crown was designed by FGP technique.
15685|NCT02609178|O3|Outcome|CON Designed Surface|The occlusal surface of the artificial crown was fabricated based on the technicians' experience.
15686|NCT02609178|O2|Outcome|AVR Designed Surface|The occlusal surface of the artificial crown was designed by setting the virtual articulator at average values, that is, 30° for the angles of the sagittal condyle and 15° for the lateral Bennett angle, and 30° for the incisal path, respectively.
15687|NCT02609178|O1|Outcome|FGP Designed Surface|The occlusal surface of the artificial crown was designed by FGP technique.
15688|NCT02609178|O3|Outcome|CON Designed Surface|The occlusal surface of the artificial crown was fabricated based on the technicians' experience.
15689|NCT02609178|O2|Outcome|AVR Designed Surface|The occlusal surface of the artificial crown was designed by setting the virtual articulator at average values, that is, 30° for the angles of the sagittal condyle and 15° for the lateral Bennett angle, and 30° for the incisal path, respectively.
15690|NCT02609178|O1|Outcome|FGP Designed Surface|The occlusal surface of the artificial crown was designed by FGP technique.
15691|NCT02609178|E1|Reported Event|Occlusal Surface Design|use computer-aided design and computer-aided manufacturing technique (CAD/CAM) to execute different occlusal surface designs of the artificial crown, including FGP design (FGP and AVR) and conventional design (CON), and evaluate their efficacy, separately
15692|NCT02609113|B3|Baseline|Total|Total of all reporting groups
15693|NCT02609113|B2|Baseline|Weaker Magnetic Wristband|"Magnetic wristband of 5 Gauss strength.~Weaker Magnetic Wristband"
15694|NCT02609113|B1|Baseline|Strong Magnetic Wristband|"Magnetic wristband of 1,795 Gauss strength~Strong Magnetic Wristband"
15695|NCT02609113|P2|Participant Flow|Weaker Magnetic Wristband|"Magnetic wristband of 5 Gauss strength.~Weaker Magnetic Wristband"
15696|NCT02609113|P1|Participant Flow|Strong Magnetic Wristband|"Magnetic wristband of 1,795 Gauss strength~Strong Magnetic Wristband"
15697|NCT02609113|O2|Outcome|Weaker Magnetic Wristband|"Magnetic wristband of 5 Gauss strength.~Weaker Magnetic Wristband"
15698|NCT02609113|O1|Outcome|Strong Magnetic Wristband|"Magnetic wristband of 1,795 Gauss strength~Strong Magnetic Wristband"
15699|NCT02609113|O2|Outcome|Weaker Magnetic Wristband|"Magnetic wristband of 5 Gauss strength.~Weaker Magnetic Wristband"
15705|NCT02609113|E2|Reported Event|Weaker Magnetic Wristband|"Magnetic wristband of 5 Gauss strength.~Weaker Magnetic Wristband"
15706|NCT02609113|E1|Reported Event|Strong Magnetic Wristband|"Magnetic wristband of 1,795 Gauss strength~Strong Magnetic Wristband"
15707|NCT02608489|B3|Baseline|Total|Total of all reporting groups
15708|NCT02608489|B2|Baseline|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
15709|NCT02608489|B1|Baseline|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
15710|NCT02608489|P2|Participant Flow|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
15711|NCT02608489|P1|Participant Flow|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
15712|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
15713|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
15714|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
15715|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
15716|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
15717|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
15718|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
15719|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
15720|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
15721|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
15722|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
15723|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
15724|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
15725|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
15726|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
15727|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
15728|NCT02608489|E2|Reported Event|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
15729|NCT02608489|E1|Reported Event|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
15730|NCT02607800|B3|Baseline|Total|Total of all reporting groups
15731|NCT02607800|B2|Baseline|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily with or without food for 12 weeks
15732|NCT02607800|B1|Baseline|SOF/VEL/VOX 8 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
15733|NCT02607800|P2|Participant Flow|SOF/VEL 12 Weeks|Sofosbuvir/Velpatasvir (Epclusa®; SOF/VEL) (400/100 mg) FDC tablet orally once daily with or without food for 12 weeks
15734|NCT02607800|P1|Participant Flow|SOF/VEL/VOX 8 Weeks|Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi®; SOF/VEL/VOX) (400/100/100 mg) fixed dose combination (FDC) tablet orally once daily with food for 8 weeks
15735|NCT02607800|O2|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily with or without food for 12 weeks
15736|NCT02607800|O1|Outcome|SOF/VEL/VOX 8 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
15737|NCT02607800|O2|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily with or without food for 12 weeks
15738|NCT02607800|O1|Outcome|SOF/VEL/VOX 8 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
15739|NCT02607800|O2|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily with or without food for 12 weeks
15740|NCT02607800|O1|Outcome|SOF/VEL/VOX 8 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
15741|NCT02607800|O2|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily with or without food for 12 weeks
15742|NCT02607800|O1|Outcome|SOF/VEL/VOX 8 Weeks|SOF/VEL/VOX (400/100/100 mg) tablet orally once daily with food for 8 weeks
15743|NCT02607800|O2|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily with or without food for 12 weeks
15744|NCT02607800|O1|Outcome|SOF/VEL/VOX 8 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
15745|NCT02607800|O2|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily with or without food for 12 weeks
15746|NCT02607800|O1|Outcome|SOF/VEL/VOX 8 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
17742|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
15747|NCT02607800|E2|Reported Event|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily with or without food for 12 weeks
15748|NCT02607800|E1|Reported Event|SOF/VEL/VOX 8 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
15749|NCT02607735|B3|Baseline|Total|Total of all reporting groups
15750|NCT02607735|B2|Baseline|Placebo (Primary Study)|SOF/VEL/VOX placebo tablet orally once daily with food for 12 weeks
15751|NCT02607735|B1|Baseline|SOF/VEL/VOX (Primary Study)|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
15752|NCT02607735|P2|Participant Flow|Placebo (Primary Study)|SOF/VEL/VOX placebo tablet orally once daily with food for 12 weeks
15753|NCT02607735|P1|Participant Flow|SOF/VEL/VOX (Primary Study)|Sofosbuvir/veltapasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) (400/100/100 mg) fixed-dose combination (FDC) tablet orally once daily with food for 12 weeks
15754|NCT02607735|O2|Outcome|Placebo (Primary Study)|SOF/VEL/VOX placebo tablet orally once daily with food for 12 weeks
15755|NCT02607735|O1|Outcome|SOF/VEL/VOX (Primary Study)|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
15756|NCT02607735|O2|Outcome|Placebo (Primary Study)|SOF/VEL/VOX placebo tablet orally once daily with food for 12 weeks
15757|NCT02607735|O1|Outcome|SOF/VEL/VOX (Primary Study)|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
15758|NCT02607735|O2|Outcome|Placebo (Primary Study)|SOF/VEL/VOX placebo tablet orally once daily with food for 12 weeks
15759|NCT02607735|O1|Outcome|SOF/VEL/VOX (Primary Study)|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
15760|NCT02607735|O2|Outcome|Placebo (Primary Study)|SOF/VEL/VOX placebo tablet orally once daily with food for 12 weeks
15761|NCT02607735|O1|Outcome|SOF/VEL/VOX (Primary Study)|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
15762|NCT02607735|O2|Outcome|Placebo (Primary Study)|SOF/VEL/VOX placebo tablet orally once daily with food for 12 weeks
15763|NCT02607735|O1|Outcome|SOF/VEL/VOX (Primary Study)|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
15764|NCT02607735|E2|Reported Event|Placebo (Primary Study)|SOF/VEL/VOX placebo administered orally once daily with food for 12 weeks
15765|NCT02607735|E1|Reported Event|SOF/VEL/VOX (Primary Study)|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
15766|NCT02606838|B1|Baseline|Persons With Diabetes|"Untrained Persons with Diabetes used the Styx Lancing Device System to obtain fingerstick and Alternate Site palm capillary blood.~Styx Lancing Device: Untrained Persons With Diabetes used the Styx Lancing Device with 28 and 30 Gauge lancets to obtain fingerstick and Alternate Site palm capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all."
15767|NCT02606838|P1|Participant Flow|Persons With Diabetes|"Untrained Persons with Diabetes used the Styx Lancing Device System to obtain fingerstick and Alternate Site palm capillary blood.~Styx Lancing Device: Untrained Persons With Diabetes used the Styx Lancing Device with 28 and 30 Gauge lancets to obtain fingerstick and Alternate Site palm capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all."
15768|NCT02606838|O1|Outcome|Persons With Diabetes|"Untrained Persons with Diabetes used the Styx Lancing Device System to obtain fingerstick and Alternate Site palm capillary blood.~Styx Lancing Device: Untrained Persons With Diabetes used the Styx Lancing Device with 28 and 30 Gauge lancets to obtain fingerstick and Alternate Site palm capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all."
15769|NCT02606838|O1|Outcome|Persons With Diabetes|Untrained subjects with Diabetes operated the Styx Lancing Device with 30 Gauge lancets to obtain AST palm capillary blood. Study staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (i.e., error messages), or not obtained at all.
15770|NCT02606838|O1|Outcome|Persons With Diabetes|Untrained subjects with Diabetes operated the Styx Lancing Device with 30 Gauge lancets to obtain fingerstick capillary blood. Study staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (i.e., error messages), or not obtained at all.
15771|NCT02606838|O1|Outcome|Persons With Diabetes|Untrained subjects with Diabetes operated the Styx Lancing Device with 28 Gauge lancets to obtain AST palm capillary blood. Study staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (i.e., error messages), or not obtained at all.
15772|NCT02606838|O1|Outcome|Persons With Diabetes|Untrained subjects with Diabetes operated the Styx Lancing Device with 28 Gauge lancets to obtain fingerstick capillary blood. Study staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (i.e., error messages), or not obtained at all.
15773|NCT02606838|E1|Reported Event|Persons With Diabetes|"Untrained Persons with Diabetes used the Styx Lancing Device System to obtain fingerstick and Alternate Site palm capillary blood.~Styx Lancing Device System: Untrained Persons With Diabetes used the Styx Lancing Device with 28 and 30 Gauge lancets to obtain fingerstick and Alternate Site palm capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all."
15774|NCT02606734|B1|Baseline|Treatment Arm|"All subjects enrolled in the trial will use the DyeVert System.~Coronary Angiography: The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases."
15775|NCT02606734|P1|Participant Flow|Treatment Arm|"All subjects enrolled in the trial will use the DyeVert System.~Coronary Angiography: The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases."
15776|NCT02606734|O1|Outcome|Treatment Arm|"All subjects enrolled in the trial will use the DyeVert System.~Coronary Angiography: The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases."
20086|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
15777|NCT02606734|E1|Reported Event|Treatment Arm|"All subjects enrolled in the trial will use the DyeVert System.~Coronary Angiography: The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases."
15778|NCT02606279|B3|Baseline|Total|Total of all reporting groups
15779|NCT02606279|B2|Baseline|Valsartan|"20 HIV-infected participants will be randomized into a blinded arm where they receive 24 weeks of valsartan therapy. For those subjects randomized to the valsartan group, they will receive valsartan 40 mg by mouth daily for 2 weeks, then increase to 80 mg by mouth daily for the remaining 22 weeks. During this time, they will undergo the same study procedures as the placebo arm.~valsartan: Valsartan will be given in increasing doses (from 40 mg to 80 mg) to those in the valsartan arm."
15780|NCT02606279|B1|Baseline|Placebo Control|"20 HIV-infected participants will be randomized into a blinded arm where they will receive 24 weeks of placebo therapy. During this time, they will undergo the same study procedures as the intervention arm.~Placebo"
15781|NCT02606279|P2|Participant Flow|Valsartan|"20 HIV-infected participants will be randomized into a blinded arm where they receive 24 weeks of valsartan therapy. For those subjects randomized to the valsartan group, they will receive valsartan 40 mg by mouth daily for 2 weeks, then increase to 80 mg by mouth daily for the remaining 22 weeks. During this time, they will undergo the same study procedures as the placebo arm.~valsartan: Valsartan will be given in increasing doses (from 40 mg to 80 mg) to those in the valsartan arm."
15782|NCT02606279|P1|Participant Flow|Placebo Control|"20 HIV-infected participants will be randomized into a blinded arm where they will receive 24 weeks of placebo therapy. During this time, they will undergo the same study procedures as the intervention arm.~Placebo"
15783|NCT02606279|O2|Outcome|Valsartan|"20 HIV-infected participants will be randomized into a blinded arm where they receive 24 weeks of valsartan therapy. For those subjects randomized to the valsartan group, they will receive valsartan 40 mg by mouth daily for 2 weeks, then increase to 80 mg by mouth daily for the remaining 22 weeks. During this time, they will undergo the same study procedures as the placebo arm.~valsartan: Valsartan will be given in increasing doses (from 40 mg to 80 mg) to those in the valsartan arm."
15784|NCT02606279|O1|Outcome|Placebo Control|"20 HIV-infected participants will be randomized into a blinded arm where they will receive 24 weeks of placebo therapy. During this time, they will undergo the same study procedures as the intervention arm.~Placebo"
15785|NCT02606279|O2|Outcome|Valsartan|"20 HIV-infected participants will be randomized into a blinded arm where they receive 24 weeks of valsartan therapy. For those subjects randomized to the valsartan group, they will receive valsartan 40 mg by mouth daily for 2 weeks, then increase to 80 mg by mouth daily for the remaining 22 weeks. During this time, they will undergo the same study procedures as the placebo arm.~valsartan: Valsartan will be given in increasing doses (from 40 mg to 80 mg) to those in the valsartan arm."
15786|NCT02606279|O1|Outcome|Placebo Control|"20 HIV-infected participants will be randomized into a blinded arm where they will receive 24 weeks of placebo therapy. During this time, they will undergo the same study procedures as the intervention arm.~Placebo"
15787|NCT02606279|O2|Outcome|Valsartan|"20 HIV-infected participants will be randomized into a blinded arm where they receive 24 weeks of valsartan therapy. For those subjects randomized to the valsartan group, they will receive valsartan 40 mg by mouth daily for 2 weeks, then increase to 80 mg by mouth daily for the remaining 22 weeks. During this time, they will undergo the same study procedures as the placebo arm.~valsartan: Valsartan will be given in increasing doses (from 40 mg to 80 mg) to those in the valsartan arm."
15788|NCT02606279|O1|Outcome|Placebo Control|"20 HIV-infected participants will be randomized into a blinded arm where they will receive 24 weeks of placebo therapy. During this time, they will undergo the same study procedures as the intervention arm.~Placebo"
15789|NCT02606279|O2|Outcome|Valsartan|"20 HIV-infected participants will be randomized into a blinded arm where they receive 24 weeks of valsartan therapy. For those subjects randomized to the valsartan group, they will receive valsartan 40 mg by mouth daily for 2 weeks, then increase to 80 mg by mouth daily for the remaining 22 weeks. During this time, they will undergo the same study procedures as the placebo arm.~valsartan: Valsartan will be given in increasing doses (from 40 mg to 80 mg) to those in the valsartan arm."
15790|NCT02606279|O1|Outcome|Placebo Control|"20 HIV-infected participants will be randomized into a blinded arm where they will receive 24 weeks of placebo therapy. During this time, they will undergo the same study procedures as the intervention arm.~Placebo"
15791|NCT02606279|E2|Reported Event|Valsartan|"20 HIV-infected participants will be randomized into a blinded arm where they receive 24 weeks of valsartan therapy. For those subjects randomized to the valsartan group, they will receive valsartan 40 mg by mouth daily for 2 weeks, then increase to 80 mg by mouth daily for the remaining 22 weeks. During this time, they will undergo the same study procedures as the placebo arm.~valsartan: Valsartan will be given in increasing doses (from 40 mg to 80 mg) to those in the valsartan arm."
15792|NCT02606279|E1|Reported Event|Placebo Control|"20 HIV-infected participants will be randomized into a blinded arm where they will receive 24 weeks of placebo therapy. During this time, they will undergo the same study procedures as the intervention arm.~Placebo"
15793|NCT02605928|B1|Baseline|BIP Needle|"Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It measures bioimpedance and detects synovial fluid during inta-articular injection.~Injeq Bioimpedance Probe (BIP) Needle: Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with synovial fluid."
15794|NCT02605928|P1|Participant Flow|BIP Needle|"Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It measures bioimpedance and detects synovial fluid during inta-articular injection.~Injeq Bioimpedance Probe (BIP) Needle: Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with synovial fluid."
15900|NCT02604407|E3|Reported Event|SHP465 37.5 mg|Participants received SHP465 capsule of 12.5 mg during week 1 and 25 mg at week 2 followed by 37.5 mg at weeks 3 and 4 orally once daily.
15795|NCT02605928|O1|Outcome|BIP Needle|"Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It measures bioimpedance and detects synovial fluid during inta-articular injection.~Injeq Bioimpedance Probe (BIP) Needle: Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with synovial fluid."
15796|NCT02605928|E1|Reported Event|BIP Needle|"Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It measures bioimpedance and detects synovial fluid during inta-articular injection.~Injeq Bioimpedance Probe (BIP) Needle: Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with synovial fluid."
15797|NCT02605863|B3|Baseline|Total|Total of all reporting groups
15798|NCT02605863|B2|Baseline|High Risk NMIBC|"Enzalutamide 160mg by mouth daily for 12 months~Enzalutamide: 160 mg by mouth daily for 12 months"
15799|NCT02605863|B1|Baseline|Intermediate Risk NMIBC|"Enzalutamide 160mg by mouth daily for 12 months~Enzalutamide: 160 mg by mouth daily for 12 months"
15800|NCT02605863|P2|Participant Flow|High Risk NMIBC|"Enzalutamide 160mg by mouth daily for 12 months~Enzalutamide: 160 mg by mouth daily for 12 months"
15801|NCT02605863|P1|Participant Flow|Intermediate Risk NMIBC|"Enzalutamide 160mg by mouth daily for 12 months~Enzalutamide: 160 mg by mouth daily for 12 months"
15802|NCT02605863|O2|Outcome|High Risk NMIBC|"Enzalutamide 160mg by mouth daily for 12 months~Enzalutamide: 160 mg by mouth daily for 12 months"
15803|NCT02605863|O1|Outcome|Intermediate Risk NMIBC|"Enzalutamide 160mg by mouth daily for 12 months~Enzalutamide: 160 mg by mouth daily for 12 months"
15804|NCT02605863|E2|Reported Event|High Risk NMIBC|"Enzalutamide 160mg by mouth daily for 12 months~Enzalutamide: 160 mg by mouth daily for 12 months"
15805|NCT02605863|E1|Reported Event|Intermediate Risk NMIBC|"Enzalutamide 160mg by mouth daily for 12 months~Enzalutamide: 160 mg by mouth daily for 12 months"
15806|NCT02605304|B3|Baseline|Total|Total of all reporting groups
15807|NCT02605304|B2|Baseline|Arm B: LDV/SOF|Ledipasvir/sofosbuvir for 24 weeks, followed by 24 weeks of post-treatment follow-up.
15808|NCT02605304|B1|Baseline|Arm A: LDV/SOF + RBV|Ledipasvir/sofosbuvir + ribavirin for 12 weeks, followed by 24 weeks of post-treatment follow-up.
15809|NCT02605304|P2|Participant Flow|Arm B: LDV/SOF|Ledipasvir/sofosbuvir for 24 weeks, followed by 24 weeks of post-treatment follow-up.
15810|NCT02605304|P1|Participant Flow|Arm A: LDV/SOF + RBV|Ledipasvir/sofosbuvir + ribavirin for 12 weeks, followed by 24 weeks of post-treatment follow-up.
15811|NCT02605304|O2|Outcome|Arm B: LDV/SOF|Ledipasvir/sofosbuvir for 24 weeks, followed by 24 weeks of post-treatment follow-up.
15812|NCT02605304|O1|Outcome|Arm A: LDV/SOF + RBV|Ledipasvir/sofosbuvir + ribavirin for 12 weeks, followed by 24 weeks of post-treatment follow-up.
15813|NCT02605304|O2|Outcome|Arm B: LDV/SOF|Ledipasvir/sofosbuvir for 24 weeks, followed by 24 weeks of post-treatment follow-up.
15814|NCT02605304|O1|Outcome|Arm A: LDV/SOF + RBV|Ledipasvir/sofosbuvir + ribavirin for 12 weeks, followed by 24 weeks of post-treatment follow-up.
15815|NCT02605304|O2|Outcome|Arm B: LDV/SOF|Ledipasvir/sofosbuvir for 24 weeks, followed by 24 weeks of post-treatment follow-up.
15816|NCT02605304|O1|Outcome|Arm A: LDV/SOF + RBV|Ledipasvir/sofosbuvir + ribavirin for 12 weeks, followed by 24 weeks of post-treatment follow-up.
15817|NCT02605304|O2|Outcome|Arm B: LDV/SOF|Ledipasvir/sofosbuvir for 24 weeks, followed by 24 weeks of post-treatment follow-up.
15818|NCT02605304|O1|Outcome|Arm A: LDV/SOF + RBV|Ledipasvir/sofosbuvir + ribavirin for 12 weeks, followed by 24 weeks of post-treatment follow-up.
15819|NCT02605304|O2|Outcome|Arm B: LDV/SOF|Ledipasvir/sofosbuvir for 24 weeks, followed by 24 weeks of post-treatment follow-up.
15820|NCT02605304|O1|Outcome|Arm A: LDV/SOF + RBV|Ledipasvir/sofosbuvir + ribavirin for 12 weeks, followed by 24 weeks of post-treatment follow-up.
15821|NCT02605304|O2|Outcome|Arm B: LDV/SOF|Ledipasvir/sofosbuvir for 24 weeks, followed by 24 weeks of post-treatment follow-up.
15822|NCT02605304|O1|Outcome|Arm A: LDV/SOF + RBV|Ledipasvir/sofosbuvir + ribavirin for 12 weeks, followed by 24 weeks of post-treatment follow-up.
15823|NCT02605304|O2|Outcome|Arm B: LDV/SOF|Ledipasvir/sofosbuvir for 24 weeks, followed by 24 weeks of post-treatment follow-up.
15824|NCT02605304|O1|Outcome|Arm A: LDV/SOF + RBV|Ledipasvir/sofosbuvir + ribavirin for 12 weeks, followed by 24 weeks of post-treatment follow-up.
15825|NCT02605304|O2|Outcome|Arm B: LDV/SOF|Ledipasvir/sofosbuvir for 24 weeks, followed by 24 weeks of post-treatment follow-up.
15826|NCT02605304|O1|Outcome|Arm A: LDV/SOF + RBV|Ledipasvir/sofosbuvir + ribavirin for 12 weeks, followed by 24 weeks of post-treatment follow-up.
15827|NCT02605304|E2|Reported Event|Arm B: LDV/SOF|Ledipasvir/sofosbuvir for 24 weeks, followed by 24 weeks of post-treatment follow-up.
15828|NCT02605304|E1|Reported Event|Arm A: LDV/SOF + RBV|Ledipasvir/sofosbuvir + ribavirin for 12 weeks, followed by 24 weeks of post-treatment follow-up.
15829|NCT02604589|B4|Baseline|Total|Total of all reporting groups
15830|NCT02604589|B3|Baseline|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
15831|NCT02604589|B2|Baseline|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
15832|NCT02604589|B1|Baseline|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
16005|NCT02604017|O2|Outcome|ABT-493/ABT-530 for 8 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
15833|NCT02604589|P3|Participant Flow|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
15834|NCT02604589|P2|Participant Flow|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
15835|NCT02604589|P1|Participant Flow|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
15836|NCT02604589|O3|Outcome|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
15837|NCT02604589|O2|Outcome|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
15838|NCT02604589|O1|Outcome|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
15839|NCT02604589|O3|Outcome|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
15840|NCT02604589|O2|Outcome|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
15841|NCT02604589|O1|Outcome|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
15842|NCT02604589|O3|Outcome|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
15843|NCT02604589|O2|Outcome|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
15844|NCT02604589|O1|Outcome|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
15845|NCT02604589|O3|Outcome|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
15846|NCT02604589|O2|Outcome|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
15847|NCT02604589|O1|Outcome|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
15848|NCT02604589|O3|Outcome|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
15849|NCT02604589|O2|Outcome|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
15850|NCT02604589|O1|Outcome|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
15851|NCT02604589|O3|Outcome|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
15852|NCT02604589|O2|Outcome|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
15853|NCT02604589|O1|Outcome|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
15854|NCT02604589|O3|Outcome|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
15855|NCT02604589|O2|Outcome|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
17743|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
15856|NCT02604589|O1|Outcome|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
15857|NCT02604589|E3|Reported Event|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
15858|NCT02604589|E2|Reported Event|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
15859|NCT02604589|E1|Reported Event|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
15860|NCT02604550|B3|Baseline|Total|Total of all reporting groups
15861|NCT02604550|B2|Baseline|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
15862|NCT02604550|B1|Baseline|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
15863|NCT02604550|P2|Participant Flow|Adductor Canal Block|Participants randomized to receive 20 milliliter (mL) of ropivacaine 0.5% in the adductor canal
15864|NCT02604550|P1|Participant Flow|Femoral Nerve Block|Participants randomized to receive 20 milliliter (mL) of ropivacaine 0.5% in the femoral nerve.
15865|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
15866|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
15867|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
15868|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
15869|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
15870|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
15871|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
15872|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
15873|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
15874|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
15875|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
15876|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
15877|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
15878|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
15879|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
15880|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
15881|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
15882|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
15883|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
15884|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
15885|NCT02604550|E2|Reported Event|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
15886|NCT02604550|E1|Reported Event|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
15887|NCT02604407|B4|Baseline|Total|Total of all reporting groups
15888|NCT02604407|B3|Baseline|SHP465 37.5 mg|Participants received SHP465 capsule of 12.5 mg during week 1 and 25 mg at week 2 followed by 37.5 mg at weeks 3 and 4 orally once daily.
15889|NCT02604407|B2|Baseline|SHP465 12.5 mg|Participants received SHP465 capsule 12.5 mg orally once daily for 4 weeks.
15890|NCT02604407|B1|Baseline|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
15891|NCT02604407|P3|Participant Flow|SHP465 37.5 mg|Participants received SHP465 capsule of 12.5 mg during week 1 and 25 mg at week 2 followed by 37.5 mg at weeks 3 and 4 orally once daily.
15892|NCT02604407|P2|Participant Flow|SHP465 12.5 mg|Participants received SHP465 capsule 12.5 milligram (mg) orally once daily for 4 weeks.
15893|NCT02604407|P1|Participant Flow|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
15894|NCT02604407|O3|Outcome|SHP465 37.5 mg|Participants received SHP465 capsule of 12.5 mg during week 1 and 25 mg at week 2 followed by 37.5 mg at weeks 3 and 4 orally once daily.
15895|NCT02604407|O2|Outcome|SHP465 12.5 mg|Participants received SHP465 capsule 12.5 mg orally once daily for 4 weeks.
15896|NCT02604407|O1|Outcome|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
15897|NCT02604407|O3|Outcome|SHP465 37.5 mg|Participants received SHP465 capsule of 12.5 mg during week 1 and 25 mg at week 2 followed by 37.5 mg at weeks 3 and 4 orally once daily.
15898|NCT02604407|O2|Outcome|SHP465 12.5 mg|Participants received SHP465 capsule 12.5 mg orally once daily for 4 weeks.
15899|NCT02604407|O1|Outcome|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
16006|NCT02604017|O1|Outcome|ABT-493/ABT-530 for 12 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
15901|NCT02604407|E2|Reported Event|SHP465 12.5 mg|Participants received SHP465 capsule 12.5 milligram (mg) orally once daily for 4 weeks.
15902|NCT02604407|E1|Reported Event|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
15903|NCT02604342|B3|Baseline|Total|Total of all reporting groups
15904|NCT02604342|B2|Baseline|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
15905|NCT02604342|B1|Baseline|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15906|NCT02604342|P2|Participant Flow|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
15907|NCT02604342|P1|Participant Flow|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15908|NCT02604342|O2|Outcome|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
15909|NCT02604342|O1|Outcome|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15910|NCT02604342|O2|Outcome|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
15911|NCT02604342|O1|Outcome|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15912|NCT02604342|O2|Outcome|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
15913|NCT02604342|O1|Outcome|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15914|NCT02604342|O2|Outcome|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
15915|NCT02604342|O1|Outcome|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15916|NCT02604342|O2|Outcome|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
15917|NCT02604342|O1|Outcome|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15918|NCT02604342|O2|Outcome|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
15919|NCT02604342|O1|Outcome|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15920|NCT02604342|O2|Outcome|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
15921|NCT02604342|O1|Outcome|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15922|NCT02604342|O2|Outcome|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
15923|NCT02604342|O1|Outcome|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15924|NCT02604342|O2|Outcome|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
15925|NCT02604342|O1|Outcome|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15926|NCT02604342|O2|Outcome|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
15927|NCT02604342|O1|Outcome|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15928|NCT02604342|O1|Outcome|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15929|NCT02604342|O1|Outcome|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15930|NCT02604342|O2|Outcome|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
17744|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
15931|NCT02604342|O1|Outcome|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15932|NCT02604342|O2|Outcome|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
15933|NCT02604342|O1|Outcome|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15934|NCT02604342|O2|Outcome|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
15935|NCT02604342|O1|Outcome|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15936|NCT02604342|O2|Outcome|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
15937|NCT02604342|O1|Outcome|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15938|NCT02604342|O2|Outcome|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
15939|NCT02604342|O1|Outcome|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15940|NCT02604342|O2|Outcome|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
15941|NCT02604342|O1|Outcome|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15942|NCT02604342|O2|Outcome|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
15943|NCT02604342|O1|Outcome|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15944|NCT02604342|O2|Outcome|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
15945|NCT02604342|O1|Outcome|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15946|NCT02604342|O2|Outcome|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
15947|NCT02604342|O1|Outcome|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15948|NCT02604342|O2|Outcome|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
15949|NCT02604342|O1|Outcome|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15950|NCT02604342|O2|Outcome|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
15951|NCT02604342|O1|Outcome|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15952|NCT02604342|O2|Outcome|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
15953|NCT02604342|O1|Outcome|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15954|NCT02604342|E2|Reported Event|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
15955|NCT02604342|E1|Reported Event|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
15956|NCT02604264|B3|Baseline|Total|Total of all reporting groups
15957|NCT02604264|B2|Baseline|Control|Standard hemodialysis end cap
15958|NCT02604264|B1|Baseline|Treatment|ClearGuard HD end cap: The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub
15959|NCT02604264|P2|Participant Flow|Control|Standard hemodialysis end cap
15960|NCT02604264|P1|Participant Flow|Treatment|ClearGuard HD end cap: The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub
15961|NCT02604264|O2|Outcome|Control|Standard hemodialysis end cap
15962|NCT02604264|O1|Outcome|Treatment|ClearGuard HD end cap: The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub
15963|NCT02604264|E2|Reported Event|Control|Standard hemodialysis end cap
15964|NCT02604264|E1|Reported Event|Treatment|ClearGuard HD end cap: The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub
15965|NCT02604173|B4|Baseline|Total|Total of all reporting groups
15966|NCT02604173|B3|Baseline|Control|"Sham inhaler as control for budesonide inhaler along with placebo pill as control for acetazolamide comparator.~Placebo: Placebo pill and sham inhaler"
15967|NCT02604173|B2|Baseline|Acetazolamide|"Acetazolimide pill as active comparator along with sham inhaler.~Acetazolamide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness"
15968|NCT02604173|B1|Baseline|Budesonide|"Budesonide inhaler as experimental treatment along with placebo pill.~Budesonide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness"
15969|NCT02604173|P3|Participant Flow|Control|"Sham inhaler as control for budesonide inhaler along with placebo pill as control for acetazolamide comparator.~Placebo: Placebo pill and sham inhaler"
15970|NCT02604173|P2|Participant Flow|Acetazolamide|"Acetazolimide pill as active comparator along with sham inhaler.~Acetazolamide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness"
15971|NCT02604173|P1|Participant Flow|Budesonide|"Budesonide inhaler as experimental treatment along with placebo pill.~Budesonide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness"
15972|NCT02604173|O3|Outcome|Control|"Sham inhaler as control for budesonide inhaler along with placebo pill as control for acetazolamide comparator.~Placebo: Placebo pill and sham inhaler"
15973|NCT02604173|O2|Outcome|Acetazolamide|"Acetazolimide pill as active comparator along with sham inhaler.~Acetazolamide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness"
15974|NCT02604173|O1|Outcome|Budesonide|"Budesonide inhaler as experimental treatment along with placebo pill.~Budesonide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness"
15975|NCT02604173|O3|Outcome|Control|"Sham inhaler as control for budesonide inhaler along with placebo pill as control for acetazolamide comparator.~Placebo: Placebo pill and sham inhaler"
15976|NCT02604173|O2|Outcome|Acetazolamide|"Acetazolimide pill as active comparator along with sham inhaler.~Acetazolamide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness"
15977|NCT02604173|O1|Outcome|Budesonide|"Budesonide inhaler as experimental treatment along with placebo pill.~Budesonide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness"
15978|NCT02604173|O3|Outcome|Control|"Sham inhaler as control for budesonide inhaler along with placebo pill as control for acetazolamide comparator.~Placebo: Placebo pill and sham inhaler"
15979|NCT02604173|O2|Outcome|Acetazolamide|"Acetazolimide pill as active comparator along with sham inhaler.~Acetazolamide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness"
15980|NCT02604173|O1|Outcome|Budesonide|"Budesonide inhaler as experimental treatment along with placebo pill.~Budesonide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness"
15981|NCT02604173|E3|Reported Event|Control|"Sham inhaler as control for budesonide inhaler along with placebo pill as control for acetazolamide comparator.~Placebo: Placebo pill and sham inhaler"
15982|NCT02604173|E2|Reported Event|Acetazolamide|"Acetazolimide pill as active comparator along with sham inhaler.~Acetazolamide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness"
15983|NCT02604173|E1|Reported Event|Budesonide|"Budesonide inhaler as experimental treatment along with placebo pill.~Budesonide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness"
15984|NCT02604017|B3|Baseline|Total|Total of all reporting groups
15985|NCT02604017|B2|Baseline|ABT-493/ABT-530 for 8 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
15986|NCT02604017|B1|Baseline|ABT-493/ABT-530 for 12 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
15987|NCT02604017|P2|Participant Flow|ABT-493/ABT-530 for 8 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
15988|NCT02604017|P1|Participant Flow|ABT-493/ABT-530 for 12 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
15989|NCT02604017|O2|Outcome|ABT-493/ABT-530 for 8 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
15990|NCT02604017|O1|Outcome|ABT-493/ABT-530 for 12 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
15991|NCT02604017|O2|Outcome|ABT-493/ABT-530 for 8 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
15992|NCT02604017|O1|Outcome|ABT-493/ABT-530 for 12 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
15993|NCT02604017|O2|Outcome|ABT-493/ABT-530 for 8 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
15994|NCT02604017|O1|Outcome|ABT-493/ABT-530 for 12 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
15995|NCT02604017|O2|Outcome|ABT-493/ABT-530 for 8 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
15996|NCT02604017|O1|Outcome|ABT-493/ABT-530 for 12 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
15997|NCT02604017|O2|Outcome|ABT-493/ABT-530 for 8 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
15998|NCT02604017|O1|Outcome|ABT-493/ABT-530 for 12 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
15999|NCT02604017|O2|Outcome|ABT-493/ABT-530 for 8 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
16000|NCT02604017|O1|Outcome|ABT-493/ABT-530 for 12 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
16001|NCT02604017|O2|Outcome|ABT-493/ABT-530 for 8 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
16002|NCT02604017|O1|Outcome|ABT-493/ABT-530 for 12 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
16003|NCT02604017|O2|Outcome|ABT-493/ABT-530 for 8 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
16004|NCT02604017|O1|Outcome|ABT-493/ABT-530 for 12 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
20087|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
16007|NCT02604017|O2|Outcome|ABT-493/ABT-530 for 8 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
16008|NCT02604017|O1|Outcome|ABT-493/ABT-530 for 12 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
16009|NCT02604017|O1|Outcome|ABT-493/ABT-530 for 12 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
16010|NCT02604017|E2|Reported Event|ABT-493/ABT-530 for 8 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
16011|NCT02604017|E1|Reported Event|ABT-493/ABT-530 for 12 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
16012|NCT02603666|B1|Baseline|Elastography|"Fibroscan elastography device for evaluation of liver disease in CF patients.~Fibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions."
16013|NCT02603666|P1|Participant Flow|Elastography|"Fibroscan elastography device for evaluation of liver disease in CF patients.~Fibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions."
16014|NCT02603666|O1|Outcome|Elastography|"Fibroscan elastography device for evaluation of liver disease in CF patients.~Fibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions."
16015|NCT02603666|E1|Reported Event|Elastography|"Fibroscan elastography device for evaluation of liver disease in CF patients.~Fibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions."
16016|NCT02602223|B1|Baseline|Amnion Chorion Membrane & d-PTFE|"Amnion chorion membrane or d-PTFE will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane or d-PTFE over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM or d-PTFE (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed."
16017|NCT02602223|P1|Participant Flow|Amnion Chorion Membrane & d-PTFE|"Amnion chorion membrane or d-PTFE will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane or d-PTFE over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM or d-PTFE (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed."
16018|NCT02602223|O2|Outcome|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side~Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
16019|NCT02602223|O1|Outcome|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
16020|NCT02602223|O2|Outcome|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side~Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
16021|NCT02602223|O1|Outcome|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
16022|NCT02602223|O2|Outcome|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side~Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
16023|NCT02602223|O1|Outcome|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
16024|NCT02602223|O2|Outcome|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side~Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
16025|NCT02602223|O1|Outcome|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
16026|NCT02602223|O2|Outcome|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side~Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
16027|NCT02602223|O1|Outcome|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
16028|NCT02602223|O2|Outcome|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side~Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
16029|NCT02602223|O1|Outcome|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
17745|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
16030|NCT02602223|E2|Reported Event|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side~Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
16031|NCT02602223|E1|Reported Event|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
16032|NCT02601573|B6|Baseline|Total|Total of all reporting groups
16033|NCT02601573|B5|Baseline|Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
16034|NCT02601573|B4|Baseline|Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
16035|NCT02601573|B3|Baseline|Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
16036|NCT02601573|B2|Baseline|Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks|TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
16037|NCT02601573|B1|Baseline|Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks|TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 8 weeks.
16038|NCT02601573|P5|Participant Flow|Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
16039|NCT02601573|P4|Participant Flow|Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
16040|NCT02601573|P3|Participant Flow|Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks|Treatment-experienced (TE) HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
16041|NCT02601573|P2|Participant Flow|Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks|TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
16042|NCT02601573|P1|Participant Flow|Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks|Treatment-naïve (TN) Hepatitis C virus (HCV) genotype 3 (GT3) participants took 1 fixed-dose combination (FDC) tablet containing elbasvir (EBR) 50 mg + grazoprevir (GZR) 100 mg and 1 tablet containing sofosbuvir (SOF) 400 mg once daily (q.d.) with ribavirin (RBV) (200 mg capsules; weight-based dosing) twice daily (b.i.d.) for 8 weeks.
16043|NCT02601573|O5|Outcome|Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
16044|NCT02601573|O4|Outcome|Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
16045|NCT02601573|O3|Outcome|Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
16046|NCT02601573|O2|Outcome|Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks|TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
16047|NCT02601573|O1|Outcome|Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks|TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 8 weeks.
16048|NCT02601573|O5|Outcome|Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
16049|NCT02601573|O4|Outcome|Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
16050|NCT02601573|O3|Outcome|Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
16051|NCT02601573|O2|Outcome|Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks|TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
16052|NCT02601573|O1|Outcome|Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks|TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 8 weeks.
16053|NCT02601573|O5|Outcome|Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
16054|NCT02601573|O4|Outcome|Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
16099|NCT02601560|O4|Outcome|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16055|NCT02601573|O3|Outcome|Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
16056|NCT02601573|O2|Outcome|Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks|TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
16057|NCT02601573|O1|Outcome|Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks|TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 8 weeks.
16058|NCT02601573|O5|Outcome|Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
16059|NCT02601573|O4|Outcome|Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
16060|NCT02601573|O3|Outcome|Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
16061|NCT02601573|O2|Outcome|Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks|TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
16062|NCT02601573|O1|Outcome|Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks|TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 8 weeks.
16063|NCT02601573|E5|Reported Event|Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
16064|NCT02601573|E4|Reported Event|Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
16065|NCT02601573|E3|Reported Event|Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
16066|NCT02601573|E2|Reported Event|Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks|TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
16067|NCT02601573|E1|Reported Event|Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks|TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 8 weeks.
16068|NCT02601560|B9|Baseline|Total|Total of all reporting groups
16069|NCT02601560|B8|Baseline|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16070|NCT02601560|B7|Baseline|MEDI6012 80 mg SC|Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
16071|NCT02601560|B6|Baseline|Placebo Subcutaneous (SC)|Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
16072|NCT02601560|B5|Baseline|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16073|NCT02601560|B4|Baseline|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
16074|NCT02601560|B3|Baseline|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16075|NCT02601560|B2|Baseline|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16076|NCT02601560|B1|Baseline|Placebo Intravenous (IV)|Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
16077|NCT02601560|P8|Participant Flow|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16078|NCT02601560|P7|Participant Flow|MEDI6012 80 mg SC|Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
16079|NCT02601560|P6|Participant Flow|Placebo Subcutaneous (SC)|Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
16080|NCT02601560|P5|Participant Flow|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16081|NCT02601560|P4|Participant Flow|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
16082|NCT02601560|P3|Participant Flow|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16083|NCT02601560|P2|Participant Flow|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16084|NCT02601560|P1|Participant Flow|Placebo Intravenous (IV)|Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
16085|NCT02601560|O8|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16086|NCT02601560|O7|Outcome|MEDI6012 80 mg SC|Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
16087|NCT02601560|O6|Outcome|Placebo Subcutaneous (SC)|Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
16088|NCT02601560|O5|Outcome|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16089|NCT02601560|O4|Outcome|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
16090|NCT02601560|O3|Outcome|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16091|NCT02601560|O2|Outcome|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16092|NCT02601560|O1|Outcome|Placebo Intravenous (IV)|Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
16093|NCT02601560|O5|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16094|NCT02601560|O4|Outcome|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16095|NCT02601560|O3|Outcome|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
16096|NCT02601560|O2|Outcome|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16097|NCT02601560|O1|Outcome|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16098|NCT02601560|O5|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16100|NCT02601560|O3|Outcome|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
16101|NCT02601560|O2|Outcome|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16102|NCT02601560|O1|Outcome|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16103|NCT02601560|O5|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16104|NCT02601560|O4|Outcome|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16105|NCT02601560|O3|Outcome|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
16106|NCT02601560|O2|Outcome|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16107|NCT02601560|O1|Outcome|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16108|NCT02601560|O5|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16109|NCT02601560|O4|Outcome|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16110|NCT02601560|O3|Outcome|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
16111|NCT02601560|O2|Outcome|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16112|NCT02601560|O1|Outcome|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16113|NCT02601560|O5|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16114|NCT02601560|O4|Outcome|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16115|NCT02601560|O3|Outcome|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
16116|NCT02601560|O2|Outcome|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16117|NCT02601560|O1|Outcome|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16118|NCT02601560|O5|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16119|NCT02601560|O4|Outcome|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16120|NCT02601560|O3|Outcome|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
16121|NCT02601560|O2|Outcome|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16122|NCT02601560|O1|Outcome|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16123|NCT02601560|O6|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16124|NCT02601560|O5|Outcome|MEDI6012 80 mg SC|Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
16125|NCT02601560|O4|Outcome|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16126|NCT02601560|O3|Outcome|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
16127|NCT02601560|O2|Outcome|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16128|NCT02601560|O1|Outcome|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16129|NCT02601560|O8|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16130|NCT02601560|O7|Outcome|MEDI6012 80 mg SC|Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
16131|NCT02601560|O6|Outcome|Placebo Subcutaneous (SC)|Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
16132|NCT02601560|O5|Outcome|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16133|NCT02601560|O4|Outcome|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
16134|NCT02601560|O3|Outcome|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16135|NCT02601560|O2|Outcome|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16136|NCT02601560|O1|Outcome|Placebo Intravenous (IV)|Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
16137|NCT02601560|O8|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16138|NCT02601560|O7|Outcome|MEDI6012 80 mg SC|Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
16139|NCT02601560|O6|Outcome|Placebo Subcutaneous (SC)|Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
16140|NCT02601560|O5|Outcome|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16141|NCT02601560|O4|Outcome|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
16142|NCT02601560|O3|Outcome|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16143|NCT02601560|O2|Outcome|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16144|NCT02601560|O1|Outcome|Placebo Intravenous (IV)|Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
16145|NCT02601560|O8|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16146|NCT02601560|O7|Outcome|MEDI6012 80 mg SC|Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
16147|NCT02601560|O6|Outcome|Placebo Subcutaneous (SC)|Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
16148|NCT02601560|O5|Outcome|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16149|NCT02601560|O4|Outcome|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
16150|NCT02601560|O3|Outcome|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16151|NCT02601560|O2|Outcome|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16152|NCT02601560|O1|Outcome|Placebo Intravenous (IV)|Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
16153|NCT02601560|O8|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16154|NCT02601560|O7|Outcome|MEDI6012 80 mg SC|Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
16155|NCT02601560|O6|Outcome|Placebo Subcutaneous (SC)|Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
16156|NCT02601560|O5|Outcome|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16157|NCT02601560|O4|Outcome|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
16158|NCT02601560|O3|Outcome|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16159|NCT02601560|O2|Outcome|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16160|NCT02601560|O1|Outcome|Placebo Intravenous (IV)|Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
16161|NCT02601560|O8|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16162|NCT02601560|O7|Outcome|MEDI6012 80 mg SC|Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
16163|NCT02601560|O6|Outcome|Placebo Subcutaneous (SC)|Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
16164|NCT02601560|O5|Outcome|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16165|NCT02601560|O4|Outcome|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
16166|NCT02601560|O3|Outcome|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16167|NCT02601560|O2|Outcome|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16168|NCT02601560|O1|Outcome|Placebo Intravenous (IV)|Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
16169|NCT02601560|O8|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16170|NCT02601560|O7|Outcome|MEDI6012 80 mg SC|Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
16171|NCT02601560|O6|Outcome|Placebo Subcutaneous (SC)|Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
16172|NCT02601560|O5|Outcome|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16173|NCT02601560|O4|Outcome|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
16174|NCT02601560|O3|Outcome|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16175|NCT02601560|O2|Outcome|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16176|NCT02601560|O1|Outcome|Placebo Intravenous (IV)|Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
16177|NCT02601560|O8|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16178|NCT02601560|O7|Outcome|MEDI6012 80 mg SC|Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
16179|NCT02601560|O6|Outcome|Placebo Subcutaneous (SC)|Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
16180|NCT02601560|O5|Outcome|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16181|NCT02601560|O4|Outcome|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
16182|NCT02601560|O3|Outcome|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16183|NCT02601560|O2|Outcome|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16184|NCT02601560|O1|Outcome|Placebo Intravenous (IV)|Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
16185|NCT02601560|O8|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16186|NCT02601560|O7|Outcome|MEDI6012 80 mg SC|Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
16187|NCT02601560|O6|Outcome|Placebo Subcutaneous (SC)|Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
16188|NCT02601560|O5|Outcome|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16189|NCT02601560|O4|Outcome|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
16190|NCT02601560|O3|Outcome|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16191|NCT02601560|O2|Outcome|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16192|NCT02601560|O1|Outcome|Placebo Intravenous (IV)|Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
16193|NCT02601560|O8|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16194|NCT02601560|O7|Outcome|MEDI6012 80 mg SC|Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
16195|NCT02601560|O6|Outcome|Placebo Subcutaneous (SC)|Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
16196|NCT02601560|O5|Outcome|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16197|NCT02601560|O4|Outcome|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
16198|NCT02601560|O3|Outcome|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16199|NCT02601560|O2|Outcome|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16200|NCT02601560|O1|Outcome|Placebo Intravenous (IV)|Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
16201|NCT02601560|O8|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16202|NCT02601560|O7|Outcome|MEDI6012 80 mg SC|Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
16203|NCT02601560|O6|Outcome|Placebo Subcutaneous (SC)|Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
16204|NCT02601560|O5|Outcome|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16205|NCT02601560|O4|Outcome|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
25769|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
16206|NCT02601560|O3|Outcome|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16207|NCT02601560|O2|Outcome|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16208|NCT02601560|O1|Outcome|Placebo Intravenous (IV)|Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
16209|NCT02601560|O8|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16210|NCT02601560|O7|Outcome|MEDI6012 80 mg SC|Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
16211|NCT02601560|O6|Outcome|Placebo Subcutaneous (SC)|Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
16212|NCT02601560|O5|Outcome|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16213|NCT02601560|O4|Outcome|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
16214|NCT02601560|O3|Outcome|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16215|NCT02601560|O2|Outcome|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16216|NCT02601560|O1|Outcome|Placebo Intravenous (IV)|Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
16217|NCT02601560|O8|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16218|NCT02601560|O7|Outcome|MEDI6012 80 mg SC|Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
16219|NCT02601560|O6|Outcome|Placebo Subcutaneous (SC)|Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
16220|NCT02601560|O5|Outcome|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16221|NCT02601560|O4|Outcome|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
16222|NCT02601560|O3|Outcome|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16223|NCT02601560|O2|Outcome|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16224|NCT02601560|O1|Outcome|Placebo Intravenous (IV)|Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
16225|NCT02601560|O8|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16226|NCT02601560|O7|Outcome|MEDI6012 80 mg SC|Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
16227|NCT02601560|O6|Outcome|Placebo Subcutaneous (SC)|Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
16228|NCT02601560|O5|Outcome|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16229|NCT02601560|O4|Outcome|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
16230|NCT02601560|O3|Outcome|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16231|NCT02601560|O2|Outcome|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16232|NCT02601560|O1|Outcome|Placebo Intravenous (IV)|Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
16233|NCT02601560|O8|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16234|NCT02601560|O7|Outcome|MEDI6012 80 mg SC|Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
16235|NCT02601560|O6|Outcome|Placebo Subcutaneous (SC)|Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
16236|NCT02601560|O5|Outcome|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16237|NCT02601560|O4|Outcome|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
16238|NCT02601560|O3|Outcome|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16239|NCT02601560|O2|Outcome|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16240|NCT02601560|O1|Outcome|Placebo Intravenous (IV)|Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
16241|NCT02601560|O8|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16242|NCT02601560|O7|Outcome|MEDI6012 80 mg SC|Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
16243|NCT02601560|O6|Outcome|Placebo Subcutaneous (SC)|Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
16244|NCT02601560|O5|Outcome|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16245|NCT02601560|O4|Outcome|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
16246|NCT02601560|O3|Outcome|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16247|NCT02601560|O2|Outcome|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16248|NCT02601560|O1|Outcome|Placebo Intravenous (IV)|Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
16249|NCT02601560|O8|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16250|NCT02601560|O7|Outcome|MEDI6012 80 mg SC|Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
16251|NCT02601560|O6|Outcome|Placebo Subcutaneous (SC)|Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
16252|NCT02601560|O5|Outcome|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16253|NCT02601560|O4|Outcome|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
16254|NCT02601560|O3|Outcome|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16255|NCT02601560|O2|Outcome|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16256|NCT02601560|O1|Outcome|Placebo Intravenous (IV)|Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
16257|NCT02601560|E8|Reported Event|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
16258|NCT02601560|E7|Reported Event|MEDI6012 80 mg SC|Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
16259|NCT02601560|E6|Reported Event|Placebo Subcutaneous (SC)|Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
16260|NCT02601560|E5|Reported Event|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
16261|NCT02601560|E4|Reported Event|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
16262|NCT02601560|E3|Reported Event|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
16263|NCT02601560|E2|Reported Event|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
16264|NCT02601560|E1|Reported Event|Placebo Intravenous (IV)|Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
16265|NCT02600871|B3|Baseline|Total|Total of all reporting groups
16266|NCT02600871|B2|Baseline|Standard Care|"Standard care patients had standard care including incision and drainage.~Standard care patients returned at 48-72 hours for a follow-up visit and have the packing removed.~Standard care patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They covered the wound with 4x4 gauze and washed hands with soap and water for 1 minute."
16267|NCT02600871|B1|Baseline|Provodine|"Provodine patients had standard care including incision and drainage. The contents of 1 packet of Provodine applied with a Q-tip to the walls and floor of the abscess cavity. Contents of a 2nd packet were applied to the surrounding skin within 5 cm around the incision.~Provodine patients returned at 48-72 hours for a follow-up visit, had the packing removed and the contents of the packet reapplied to the abscess cavity and surrounding skin.~Provodine patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They washed their hands with soap and water, patted dry, and applied the contents of 1 packet of Provodine to dorsum and palmar aspects of hands and fingers and rubbed together for 1 minute. They applied the contents of a 2nd packet to the abscess cavity, and a 3rd packet to the surrounding skin. They rinsed their hands with water, patted dry, and covered the wound with 4x4 gauze."
16268|NCT02600871|P2|Participant Flow|Standard Care|"Standard care patients had standard care including incision and drainage.~Standard care patients returned at 48-72 hours for a follow-up visit and had the packing removed.~Standard care patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They covered wound with 4x4 gauze and washed hands with soap and water for 1 minute."
16269|NCT02600871|P1|Participant Flow|Provodine|"Provodine patients had standard care including incision and drainage. The contents of 1 packet of Provodine were applied with a Q-tip to the walls and floor of the abscess cavity. The contents of a 2nd packet were applied to the surrounding skin within 5 cm around the incision.~Provodine patients returned at 48-72 hours for a follow-up visit, had the packing removed and the contents of the packet reapplied to the abscess cavity and surrounding skin.~Provodine patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They washed their hands with soap and water, patted dry, and applied the contents of 1 packet of Provodine to dorsum and palmar aspects of hands and fingers and rubbed together for 1 minute. They applied the contents of a 2nd packet to the abscess cavity, and a 3rd packet to the surrounding skin. They rinsed their hands with water, patted dry, and cover ed the wound with 4x4 gauze."
16270|NCT02600871|O2|Outcome|Standard Care|"Standard care patients had standard care including incision and drainage.~Standard care patients returned at 48-72 hours for a follow-up visit and had the packing removed.~Standard care patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They covered wound with 4x4 gauze and washed hands with soap and water for 1 minute."
16271|NCT02600871|O1|Outcome|Provodine|"Provodine patients had standard care including incision and drainage. The contents of 1 packet of Provodine was applied with a Q-tip to the walls and floor of the abscess cavity. The contents of a 2nd packet were applied to the surrounding skin within 5 cm around the incision.~Provodine patients returned at 48-72 hours for a follow-up visit, had the packing removed and the contents of the packet reapplied to the abscess cavity and surrounding skin.~Provodine patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They washed their hands with soap and water, patted dry, and applied the contents of 1 packet of Provodine to dorsum and palmar aspects of hands and fingers and rubbed together for 1 minute. They applied the contents of a 2nd packet to the abscess cavity, and a 3rd packet to the surrounding skin. They rinsed their hands with water, patted dry, and covered the wound with 4x4 gauze."
16272|NCT02600871|O2|Outcome|Standard Care|"Standard care patients had standard care including incision and drainage.~Standard care patients returned at 48-72 hours for a follow-up visit and had the packing removed.~Standard care patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They covered wound with 4x4 gauze and washed hands with soap and water for 1 minute."
16273|NCT02600871|O1|Outcome|Provodine|"Provodine patients had standard care including incision and drainage. The contents of 1 packet of Provodine was applied with a Q-tip to the walls and floor of the abscess cavity. The contents of a 2nd packet were applied to the surrounding skin within 5 cm around the incision.~Provodine patients returned at 48-72 hours for a follow-up visit, had the packing removed and the contents of the packet reapplied to the abscess cavity and surrounding skin.~Provodine patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They washed their hands with soap and water, patted dry, and applied the contents of 1 packet of Provodine to dorsum and palmar aspects of hands and fingers and rubbed together for 1 minute. They applied the contents of a 2nd packet to the abscess cavity, and a 3rd packet to the surrounding skin. They rinsed their hands with water, patted dry, and covered the wound with 4x4 gauze."
16274|NCT02600871|O2|Outcome|Standard Care|"Standard care patients had standard care including incision and drainage.~Standard care patients returned within 48-72 hours for a follow-up visit and had the packing removed.~Standard care patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They then covered wound with 4x4 gauze and washed hands with soap and water for 1 minute."
16337|NCT02600351|O1|Outcome|LDV/SOF 12 Weeks, Without Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks in participants without cirrhosis
16338|NCT02600351|O4|Outcome|LDV/SOF 24 Weeks, With Compensated Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
16275|NCT02600871|O1|Outcome|Provodine|"Provodine patients had standard care including incision and drainage. The contents of 1 packet of Provodine was applied with a Q-tip to the walls and floor of the abscess cavity. The contents of a 2nd packet were applied to the surrounding skin within 5 cm around the incision.~Provodine patients returned at 48-72 hours for a follow-up visit, had the packing removed and the contents of the packet reapplied to the abscess cavity and surrounding skin.~Provodine patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They washed their hands with soap and water, patted dry, and applied the contents of 1 packet of Provodine to dorsum and palmar aspects of hands and fingers and rubbed together for 1 minute. They applied the contents of a 2nd packet to the abscess cavity, and a 3rd packet to the surrounding skin. They rinsed their hands with water, patted dry, and covered the wound with 4x4 gauze."
16276|NCT02600871|E2|Reported Event|Standard Care|"Standard care patients had standard care including incision and drainage.~Standard care patients returned at 48-72 hours for a follow-up visit and had the packing removed.~Standard care patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They covered wound with 4x4 gauze and washed hands with soap and water for 1 minute."
16277|NCT02600871|E1|Reported Event|Provodine|"Provodine patients had standard care including incision and drainage. The contents of 1 packet of Provodine was applied with a Q-tip to the walls and floor of the abscess cavity. The contents of a 2nd packet were applied to the surrounding skin within 5 cm around the incision.~Provodine patients returned at 48-72 hours for a follow-up visit, had the packing removed and the contents of the packet reapplied to the abscess cavity and surrounding skin.~Provodine patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They washed their hands with soap and water, patted dry, and applied the contents of 1 packet of Provodine to dorsum and palmar aspects of hands and fingers and rubbed together for 1 minute. They applied the contents of a 2nd packet to the abscess cavity, and a 3rd packet to the surrounding skin. They rinsed their hands with water, patted dry, and covered the wound with 4x4 gauze."
16278|NCT02600845|B1|Baseline|ACCU-CHEK|All participants utilized ACCU-CHEK Connect Diabetes Management System containing three primary components: ACCU-CHEK Aviva Connect Blood Glucose Monitoring System intended to be used for the quantitative measurement of glucose, ACCU-CHEK Connect Diabetes Management App indicated as an aid in the treatment of diabetes, and ACCU-CHEK Connect Online Diabetes Management System indicated for use by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
16279|NCT02600845|P1|Participant Flow|ACCU-CHEK|All participants utilized ACCU-CHEK Connect Diabetes Management System containing three primary components: ACCU-CHEK Aviva Connect Blood Glucose Monitoring System intended to be used for the quantitative measurement of glucose, ACCU-CHEK Connect Diabetes Management App indicated as an aid in the treatment of diabetes, and ACCU-CHEK Connect Online Diabetes Management System indicated for use by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
16280|NCT02600845|O1|Outcome|ACCU-CHEK|All participants utilized ACCU-CHEK Connect Diabetes Management System containing three primary components: ACCU-CHEK Aviva Connect Blood Glucose Monitoring System intended to be used for the quantitative measurement of glucose, ACCU-CHEK Connect Diabetes Management App indicated as an aid in the treatment of diabetes, and ACCU-CHEK Connect Online Diabetes Management System indicated for use by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
16281|NCT02600845|O1|Outcome|ACCU-CHEK|All participants utilized ACCU-CHEK Connect Diabetes Management System containing three primary components: ACCU-CHEK Aviva Connect Blood Glucose Monitoring System intended to be used for the quantitative measurement of glucose, ACCU-CHEK Connect Diabetes Management App indicated as an aid in the treatment of diabetes, and ACCU-CHEK Connect Online Diabetes Management System indicated for use by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
16282|NCT02600845|O1|Outcome|ACCU-CHEK|All participants utilized ACCU-CHEK Connect Diabetes Management System containing three primary components: ACCU-CHEK Aviva Connect Blood Glucose Monitoring System intended to be used for the quantitative measurement of glucose, ACCU-CHEK Connect Diabetes Management App indicated as an aid in the treatment of diabetes, and ACCU-CHEK Connect Online Diabetes Management System indicated for use by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
16283|NCT02600845|O1|Outcome|ACCU-CHEK|All participants utilized ACCU-CHEK Connect Diabetes Management System containing three primary components: ACCU-CHEK Aviva Connect Blood Glucose Monitoring System intended to be used for the quantitative measurement of glucose, ACCU-CHEK Connect Diabetes Management App indicated as an aid in the treatment of diabetes, and ACCU-CHEK Connect Online Diabetes Management System indicated for use by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
16284|NCT02600845|O1|Outcome|ACCU-CHEK|All participants utilized ACCU-CHEK Connect Diabetes Management System containing three primary components: ACCU-CHEK Aviva Connect Blood Glucose Monitoring System intended to be used for the quantitative measurement of glucose, ACCU-CHEK Connect Diabetes Management App indicated as an aid in the treatment of diabetes, and ACCU-CHEK Connect Online Diabetes Management System indicated for use by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
16285|NCT02600845|O1|Outcome|ACCU-CHEK|All participants utilized ACCU-CHEK Connect Diabetes Management System containing three primary components: ACCU-CHEK Aviva Connect Blood Glucose Monitoring System intended to be used for the quantitative measurement of glucose, ACCU-CHEK Connect Diabetes Management App indicated as an aid in the treatment of diabetes, and ACCU-CHEK Connect Online Diabetes Management System indicated for use by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
16286|NCT02600845|O1|Outcome|ACCU-CHEK|All participants utilized ACCU-CHEK Connect Diabetes Management System containing three primary components: ACCU-CHEK Aviva Connect Blood Glucose Monitoring System intended to be used for the quantitative measurement of glucose, ACCU-CHEK Connect Diabetes Management App indicated as an aid in the treatment of diabetes, and ACCU-CHEK Connect Online Diabetes Management System indicated for use by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
16339|NCT02600351|O3|Outcome|LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
16340|NCT02600351|O2|Outcome|LDV/SOF + RBV 12 Weeks, Without Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
16287|NCT02600845|O1|Outcome|ACCU-CHEK|All participants utilized ACCU-CHEK Connect Diabetes Management System containing three primary components: ACCU-CHEK Aviva Connect Blood Glucose Monitoring System intended to be used for the quantitative measurement of glucose, ACCU-CHEK Connect Diabetes Management App indicated as an aid in the treatment of diabetes, and ACCU-CHEK Connect Online Diabetes Management System indicated for use by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
16288|NCT02600845|O1|Outcome|ACCU-CHEK|All participants utilized ACCU-CHEK Connect Diabetes Management System containing three primary components: ACCU-CHEK Aviva Connect Blood Glucose Monitoring System intended to be used for the quantitative measurement of glucose, ACCU-CHEK Connect Diabetes Management App indicated as an aid in the treatment of diabetes, and ACCU-CHEK Connect Online Diabetes Management System indicated for use by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
16289|NCT02600845|O1|Outcome|ACCU-CHEK|All participants utilized ACCU-CHEK Connect Diabetes Management System containing three primary components: ACCU-CHEK Aviva Connect Blood Glucose Monitoring System intended to be used for the quantitative measurement of glucose, ACCU-CHEK Connect Diabetes Management App indicated as an aid in the treatment of diabetes, and ACCU-CHEK Connect Online Diabetes Management System indicated for use by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
16290|NCT02600845|O1|Outcome|ACCU-CHEK|All participants utilized ACCU-CHEK Connect Diabetes Management System containing three primary components: ACCU-CHEK Aviva Connect Blood Glucose Monitoring System intended to be used for the quantitative measurement of glucose, ACCU-CHEK Connect Diabetes Management App indicated as an aid in the treatment of diabetes, and ACCU-CHEK Connect Online Diabetes Management System indicated for use by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
16291|NCT02600845|O1|Outcome|ACCU-CHEK|All participants utilized ACCU-CHEK Connect Diabetes Management System containing three primary components: ACCU-CHEK Aviva Connect Blood Glucose Monitoring System intended to be used for the quantitative measurement of glucose, ACCU-CHEK Connect Diabetes Management App indicated as an aid in the treatment of diabetes, and ACCU-CHEK Connect Online Diabetes Management System indicated for use by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
16292|NCT02600845|E1|Reported Event|ACCU-CHEK|All participants utilized ACCU-CHEK Connect Diabetes Management System containing three primary components: ACCU-CHEK Aviva Connect Blood Glucose Monitoring System intended to be used for the quantitative measurement of glucose, ACCU-CHEK Connect Diabetes Management App indicated as an aid in the treatment of diabetes, and ACCU-CHEK Connect Online Diabetes Management System indicated for use by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
16293|NCT02600767|B1|Baseline|Artemether-Lumefantrine|"Three days of standard treatment. This is a standard combination therapy for the treatment of P. falciparum malaria.~Artemether-lumefantrine combination: This is the sole arm in this study and it is the use of the standard combination therapy for treatment of P. falciparum malaria."
16294|NCT02600767|P1|Participant Flow|Artemether-Lumefantrine|"Three days of standard treatment. This is a standard combination therapy for the treatment of P. falciparum malaria.~Artemether-lumefantrine combination: This is the sole arm in this study and it is the use of the standard combination therapy for treatment of P. falciparum malaria."
16295|NCT02600767|O1|Outcome|Artemether-Lumefantrine|"Three days of standard treatment. This is a standard combination therapy for the treatment of P. falciparum malaria.~Artemether-lumefantrine combination: This is the sole arm in this study and it is the use of the standard combination therapy for treatment of P. falciparum malaria."
16296|NCT02600767|E1|Reported Event|Artemether-Lumefantrine|"Three days of standard treatment. This is a standard combination therapy for the treatment of P. falciparum malaria.~Artemether-lumefantrine combination: This is the sole arm in this study and it is the use of the standard combination therapy for treatment of P. falciparum malaria."
16297|NCT02600403|B4|Baseline|Total|Total of all reporting groups
16298|NCT02600403|B3|Baseline|Control Glaucoma Subjects|"Eleven (11) patients will have testing done using optical coherence tomography (OCT), Visual Evoked Potential (VEP) and visual field (VF).~Testing will be repeated at 1-2 months, 4-6 months and 9-12 months after the initial testing was completed.~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
16299|NCT02600403|B2|Baseline|Glaucoma Subjects With Intra-ocular Pressure >32 mmHg|"Six (6) patients will have testing done using optical coherence tomography (OCT), Visual Evoked Potential (VEP) and visual field (VF).~This testing will be repeated one (1) hour, one (1) day and three (3) months following the eye pressure lowering intervention.~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
16300|NCT02600403|B1|Baseline|Glaucoma Subjects With Intra-ocular Pressure 22-32 mmHg|"Forty four (44) patients will have testing done using optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF).~Testing will be repeated at 1-2 months, 4-6 months and 9-12 months after the initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT’s and one (1) VEP).~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
16341|NCT02600351|O1|Outcome|LDV/SOF 12 Weeks, Without Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks in participants without cirrhosis
17746|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
16301|NCT02600403|P3|Participant Flow|Control Glaucoma Subjects|"Eleven (11) patients will have testing done using optical coherence tomography (OCT), Visual Evoked Potential (VEP) and visual field (VF).~Testing will be repeated at 1-2 months, 4-6 months and 9-12 months after the initial testing was completed.~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
16302|NCT02600403|P2|Participant Flow|Glaucoma Subjects With IOP >32 mmHg|"Six (6) patients will have testing done using optical coherence tomography (OCT), Visual Evoked Potential (VEP) and visual field (VF).~This testing will be repeated one (1) hour, one (1) day and three (3) months following the eye pressure lowering intervention.~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
16303|NCT02600403|P1|Participant Flow|Glaucoma Subjects With IOP 22-32 mmHg|"Forty four (44) patients will have testing done using optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF).~Testing will be repeated at 1-2 months, 4-6 months and 9-12 months after the initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT’s and one (1) VEP).~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
16304|NCT02600403|O3|Outcome|Control Glaucoma Subjects|"Eleven (11) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT’s and one (1) VEP).~Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.~Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.~Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma."
16305|NCT02600403|O2|Outcome|Glaucoma Subjects With IOP >32 mmHg|"Six (6) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT’s and one (1) VEP).~Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.~Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.~Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma."
16306|NCT02600403|O1|Outcome|Glaucoma Subjects With IOP 22-32 mmHg|"Forty four (44) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT’s and one (1) VEP).~Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.~Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.~Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma."
16307|NCT02600403|O3|Outcome|Control Glaucoma Subjects|"Eleven (11) patients will have testing done using optical coherence tomography (OCT), Visual Evoked Potential (VEP) and visual field (VF).~Testing will be repeated at 1-2 months, 4-6 months and 9-12 months after the initial testing was completed.~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
16308|NCT02600403|O2|Outcome|Glaucoma Subjects With IOP >32 mmHg|"Six (6) patients will have testing done using optical coherence tomography (OCT), Visual Evoked Potential (VEP) and visual field (VF).~This testing will be repeated one (1) hour, one (1) day and three (3) months following the eye pressure lowering intervention.~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
16309|NCT02600403|O1|Outcome|Glaucoma Subjects With IOP 22-32 mmHg|"Forty four (44) patients will have testing done using optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF).~Testing will be repeated at 1-2 months, 4-6 months and 9-12 months after the initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT’s and one (1) VEP).~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
16310|NCT02600403|O3|Outcome|Control Glaucoma Subjects|"Eleven (11) patients will have testing done using optical coherence tomography (OCT), Visual Evoked Potential (VEP) and visual field (VF).~Testing will be repeated at 1-2 months, 4-6 months and 9-12 months after the initial testing was completed.~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
16311|NCT02600403|O2|Outcome|Glaucoma Subjects With IOP >32 mmHg|"Six (6) patients will have testing done using optical coherence tomography (OCT), Visual Evoked Potential (VEP) and visual field (VF).~This testing will be repeated one (1) hour, one (1) day and three (3) months following the eye pressure lowering intervention.~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
16312|NCT02600403|O1|Outcome|Glaucoma Subjects With IOP 22-32 mmHg|"Forty four (44) patients will have testing done using optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF).~Testing will be repeated at 1-2 months, 4-6 months and 9-12 months after the initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT’s and one (1) VEP).~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
16313|NCT02600403|O3|Outcome|Control Glaucoma Subjects|"Eleven (11) patients will have testing done using optical coherence tomography (OCT), Visual Evoked Potential (VEP) and visual field (VF).~Testing will be repeated at 1-2 months, 4-6 months and 9-12 months after the initial testing was completed.~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
16314|NCT02600403|O2|Outcome|Glaucoma Subjects With IOP >32 mmHg|"Six (6) patients will have testing done using optical coherence tomography (OCT), Visual Evoked Potential (VEP) and visual field (VF).~This testing will be repeated one (1) hour, one (1) day and three (3) months following the eye pressure lowering intervention.~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
16315|NCT02600403|O1|Outcome|Glaucoma Subjects With IOP 22-32 mmHg|"Forty four (44) patients will have testing done using optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF).~Testing will be repeated at 1-2 months, 4-6 months and 9-12 months after the initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT’s and one (1) VEP).~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
16316|NCT02600403|O3|Outcome|Control Glaucoma Subjects|"Eleven (11) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT’s and one (1) VEP).~Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.~Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.~Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma."
16317|NCT02600403|O2|Outcome|Glaucoma Subjects With IOP >32 mmHg|"Six (6) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT’s and one (1) VEP).~Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.~Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.~Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma."
16318|NCT02600403|O1|Outcome|Glaucoma Subjects With IOP 22-32 mmHg|"Forty four (44) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT’s and one (1) VEP).~Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.~Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.~Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma."
16319|NCT02600403|O3|Outcome|Control Glaucoma Subjects|"Eleven (11) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT’s and one (1) VEP).~Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.~Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.~Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma."
16320|NCT02600403|O2|Outcome|Glaucoma Subjects With IOP >32 mmHg|"Six (6) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT’s and one (1) VEP).~Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.~Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.~Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma."
16321|NCT02600403|O1|Outcome|Glaucoma Subjects With IOP 22-32 mmHg|"Forty four (44) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT’s and one (1) VEP).~Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.~Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.~Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma."
16322|NCT02600403|E3|Reported Event|Control Glaucoma Subjects|"Eleven (11) patients will have testing done using optical coherence tomography (OCT), Visual Evoked Potential (VEP) and visual field (VF).~Testing will be repeated at 1-2 months, 4-6 months and 9-12 months after the initial testing was completed.~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
16323|NCT02600403|E2|Reported Event|Glaucoma Subjects With IOP >32 mmHg|"Six (6) patients will have testing done using optical coherence tomography (OCT), Visual Evoked Potential (VEP) and visual field (VF).~This testing will be repeated one (1) hour, one (1) day and three (3) months following the eye pressure lowering intervention.~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
16324|NCT02600403|E1|Reported Event|Glaucoma Subjects With IOP 22-32 mmHg|"Forty four (44) patients will have testing done using optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF).~Testing will be repeated at 1-2 months, 4-6 months and 9-12 months after the initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT’s and one (1) VEP).~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
16325|NCT02600351|B5|Baseline|Total|Total of all reporting groups
16326|NCT02600351|B4|Baseline|LDV/SOF 24 Weeks, With Compensated Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
16327|NCT02600351|B3|Baseline|LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis|LDV/SOF FDC (90 mg/400 mg) tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
16328|NCT02600351|B2|Baseline|LDV/SOF + RBV 12 Weeks, Without Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
16329|NCT02600351|B1|Baseline|LDV/SOF 12 Weeks, Without Cirrhosis|LDV/SOF (90/400 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks in participants without cirrhosis
16330|NCT02600351|P4|Participant Flow|LDV/SOF 24 Weeks, With Compensated Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
16331|NCT02600351|P3|Participant Flow|LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis|LDV/SOF (90 mg/400 mg) FDC tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
16332|NCT02600351|P2|Participant Flow|LDV/SOF + RBV 12 Weeks, Without Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
16333|NCT02600351|P1|Participant Flow|LDV/SOF 12 Weeks, Without Cirrhosis|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks in participants without cirrhosis
16334|NCT02600351|O4|Outcome|LDV/SOF 24 Weeks, With Compensated Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
16335|NCT02600351|O3|Outcome|LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis|LDV/SOF FDC (90/400 mg) tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
16336|NCT02600351|O2|Outcome|LDV/SOF + RBV 12 Weeks, Without Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
16342|NCT02600351|O4|Outcome|LDV/SOF 24 Weeks, With Compensated Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
16343|NCT02600351|O3|Outcome|LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
16344|NCT02600351|O2|Outcome|LDV/SOF + RBV 12 Weeks, Without Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
16345|NCT02600351|O1|Outcome|LDV/SOF 12 Weeks, Without Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks in participants without cirrhosis
16346|NCT02600351|O4|Outcome|LDV/SOF 24 Weeks, With Compensated Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
16347|NCT02600351|O3|Outcome|LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis|LDV/SOF (90 mg/400 mg) FDC tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
16348|NCT02600351|O2|Outcome|LDV/SOF + RBV 12 Weeks, Without Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
16349|NCT02600351|O1|Outcome|LDV/SOF 12 Weeks, Without Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks in participants without cirrhosis
16350|NCT02600351|O4|Outcome|LDV/SOF 24 Weeks, With Compensated Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
16351|NCT02600351|O3|Outcome|LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
16352|NCT02600351|O2|Outcome|LDV/SOF + RBV 12 Weeks, Without Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
16353|NCT02600351|O1|Outcome|LDV/SOF 12 Weeks, Without Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks in participants without cirrhosis
16354|NCT02600351|O4|Outcome|LDV/SOF 24 Weeks, With Compensated Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
16355|NCT02600351|O3|Outcome|LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
16356|NCT02600351|O2|Outcome|LDV/SOF + RBV 12 Weeks, Without Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
16357|NCT02600351|O1|Outcome|LDV/SOF 12 Weeks, Without Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks in participants without cirrhosis
16358|NCT02600351|E4|Reported Event|LDV/SOF 24 Weeks, With Compensated Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
16359|NCT02600351|E3|Reported Event|LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis|LDV/SOF FDC (90 mg/400 mg) tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
16360|NCT02600351|E2|Reported Event|LDV/SOF + RBV 12 Weeks, Without Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
16361|NCT02600351|E1|Reported Event|LDV/SOF 12 Weeks, Without Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks in participants without cirrhosis
16362|NCT02599129|B3|Baseline|Total|Total of all reporting groups
16363|NCT02599129|B2|Baseline|Placebo|Placebo: subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.
16364|NCT02599129|B1|Baseline|Secukinumab|Secukinumab: subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20.
16365|NCT02599129|P2|Participant Flow|Placebo|Placebo: subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.
16366|NCT02599129|P1|Participant Flow|Secukinumab|Secukinumab: subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20.
16367|NCT02599129|O2|Outcome|Placebo|Placebo: subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.
16368|NCT02599129|O1|Outcome|Secukinumab|Secukinumab: subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20.
16369|NCT02599129|O2|Outcome|Placebo|Placebo: subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.
16370|NCT02599129|O1|Outcome|Secukinumab|Secukinumab: subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20.
16371|NCT02599129|O2|Outcome|Placebo|Placebo: subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.
16372|NCT02599129|O1|Outcome|Secukinumab|Secukinumab: subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20.
16373|NCT02599129|O2|Outcome|Placebo|Placebo: subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.
16374|NCT02599129|O1|Outcome|Secukinumab|Secukinumab: subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20.
16375|NCT02599129|O2|Outcome|Placebo|Placebo: subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.
16376|NCT02599129|O1|Outcome|Secukinumab|Secukinumab: subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20.
16377|NCT02599129|E2|Reported Event|Placebo|Placebo: subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.
16378|NCT02599129|E1|Reported Event|Secukinumab|Secukinumab: subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20.
16379|NCT02598934|B3|Baseline|Total|Total of all reporting groups
16536|NCT02597049|E2|Reported Event|0.75 mg Dulaglutide|Dulaglutide 0.75 mg given subcutaneously (SC) once a week (QW) for 24 weeks.
16380|NCT02598934|B2|Baseline|Ibandronate (Non-consult Group)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response.
16381|NCT02598934|B1|Baseline|Ibandronate (Consult Group)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and received physician consultation on BTM response.
16382|NCT02598934|P2|Participant Flow|Ibandronate (Non-consult Group)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response.
16383|NCT02598934|P1|Participant Flow|Ibandronate (Consult Group)|Participants received ibandronate 150-milligram (mg) tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and received physician consultation on bone turnover marker (BTM) response.
16384|NCT02598934|O2|Outcome|Ibandronate (Non-consult Group)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response.
16385|NCT02598934|O1|Outcome|Ibandronate (Consult Group)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and received physician consultation on BTM response.
16386|NCT02598934|O1|Outcome|Ibandronate (All Participants)|"Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.~Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group."
16387|NCT02598934|O1|Outcome|Ibandronate (All Participants)|"Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.~Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group."
16388|NCT02598934|O1|Outcome|Ibandronate (All Participants)|"Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.~Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group."
16389|NCT02598934|O1|Outcome|Ibandronate (All Participants)|"Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.~Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group."
16390|NCT02598934|O1|Outcome|Ibandronate (All Participants)|"Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.~Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group."
16391|NCT02598934|E1|Reported Event|Ibandronate (All Participants)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months. Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group.
16392|NCT02598622|B3|Baseline|Total|Total of all reporting groups
16393|NCT02598622|B2|Baseline|Acetyl-L-Carnitine or Placebo|"Subjects 16-30 will be randomized to receive drug or placebo.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.~Placebo: Placebo is taken 2 times a day for days 1 through 21."
16394|NCT02598622|B1|Baseline|Acetyl-L-Carnitine Only|"The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21."
16395|NCT02598622|P2|Participant Flow|Acetyl-L-Carnitine or Placebo|"Subjects 16-30 will be randomized to receive drug or placebo.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.~Placebo: Placebo is taken 2 times a day for days 1 through 21."
16396|NCT02598622|P1|Participant Flow|Acetyl-L-Carnitine Only|"The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21."
16397|NCT02598622|O2|Outcome|Acetyl-L-Carnitine or Placebo|"Subjects 16-30 will be randomized to receive drug or placebo.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.~Placebo: Placebo is taken 2 times a day for days 1 through 21."
16398|NCT02598622|O1|Outcome|Acetyl-L-Carnitine Only|"The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21."
16399|NCT02598622|E2|Reported Event|Acetyl-L-Carnitine or Placebo|"Subjects 16-30 will be randomized to receive drug or placebo.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.~Placebo: Placebo is taken 2 times a day for days 1 through 21."
16400|NCT02598622|E1|Reported Event|Acetyl-L-Carnitine Only|"The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21."
16401|NCT02598583|B3|Baseline|Total|Total of all reporting groups
16402|NCT02598583|B2|Baseline|ALXN1210 Cohort 2|"Induction phase: 600 mg on Day 1, 900 mg on Day 15~Maintenance phase: 1800 mg on Day 29 and each month thereafter"
16403|NCT02598583|B1|Baseline|ALXN1210 Cohort 1|"Induction phase: a) 400 mg on Day 1 and Day 8, 600 mg on Day 15; OR b) 600 mg on Day 1, 600 mg on Day 15~Maintenance phase: 900 mg on Day 29 and each month thereafter"
16404|NCT02598583|P2|Participant Flow|ALXN1210 Cohort 2|"Induction phase: 600 mg on Day 1, 900 mg on Day 15~Maintenance phase: 1800 mg on Day 29 and each month thereafter"
16405|NCT02598583|P1|Participant Flow|ALXN1210 Cohort 1|"Induction phase: a) 400 mg on Day 1 and Day 8, 600 mg on Day 15; OR b) 600 mg on Day 1, 600 mg on Day 15~Maintenance phase: 900 mg on Day 29 and each month thereafter"
16406|NCT02598583|O2|Outcome|ALXN1210 Cohort 2|"Induction phase: 600 mg on Day 1, 900 mg on Day 15~Maintenance phase: 1800 mg on Day 29 and each month thereafter"
16407|NCT02598583|O1|Outcome|ALXN1210 Cohort 1|"Induction phase: a) 400 mg on Day 1 and Day 8, 600 mg on Day 15; OR b) 600 mg on Day 1, 600 mg on Day 15~Maintenance phase: 900 mg on Day 29 and each month thereafter"
16408|NCT02598583|O2|Outcome|ALXN1210 Cohort 2|"Induction phase: 600 mg on Day 1, 900 mg on Day 15~Maintenance phase: 1800 mg on Day 29 and each month thereafter"
16409|NCT02598583|O1|Outcome|ALXN1210 Cohort 1|"Induction phase: a) 400 mg on Day 1 and Day 8, 600 mg on Day 15; OR b) 600 mg on Day 1, 600 mg on Day 15~Maintenance phase: 900 mg on Day 29 and each month thereafter"
16410|NCT02598583|O2|Outcome|ALXN1210 Cohort 2|"Induction phase: 600 mg on Day 1, 900 mg on Day 15~Maintenance phase: 1800 mg on Day 29 and each month thereafter"
16411|NCT02598583|O1|Outcome|ALXN1210 Cohort 1|"Induction phase: a) 400 mg on Day 1 and Day 8, 600 mg on Day 15; OR b) 600 mg on Day 1, 600 mg on Day 15~Maintenance phase: 900 mg on Day 29 and each month thereafter"
16412|NCT02598583|O2|Outcome|ALXN1210 Cohort 2|"Induction phase: 600 mg on Day 1, 900 mg on Day 15~Maintenance phase: 1800 mg on Day 29 and each month thereafter"
16413|NCT02598583|O1|Outcome|ALXN1210 Cohort 1|"Induction phase: a) 400 mg on Day 1 and Day 8, 600 mg on Day 15; OR b) 600 mg on Day 1, 600 mg on Day 15~Maintenance phase: 900 mg on Day 29 and each month thereafter"
16414|NCT02598583|O2|Outcome|ALXN1210 Cohort 2|"Induction phase: 600 mg on Day 1, 900 mg on Day 15~Maintenance phase: 1800 mg on Day 29 and each month thereafter"
16415|NCT02598583|O1|Outcome|ALXN1210 Cohort 1|"Induction phase: a) 400 mg on Day 1 and Day 8, 600 mg on Day 15; OR b) 600 mg on Day 1, 600 mg on Day 15~Maintenance phase: 900 mg on Day 29 and each month thereafter"
16416|NCT02598583|O2|Outcome|ALXN1210 Cohort 2|"Induction phase: 600 mg on Day 1, 900 mg on Day 15~Maintenance phase: 1800 mg on Day 29 and each month thereafter"
16417|NCT02598583|O1|Outcome|ALXN1210 Cohort 1|"Induction phase: a) 400 mg on Day 1 and Day 8, 600 mg on Day 15; OR b) 600 mg on Day 1, 600 mg on Day 15~Maintenance phase: 900 mg on Day 29 and each month thereafter"
16418|NCT02598583|O2|Outcome|ALXN1210 Cohort 2|"Induction phase: 600 mg on Day 1, 900 mg on Day 15~Maintenance phase: 1800 mg on Day 29 and each month thereafter"
16419|NCT02598583|O1|Outcome|ALXN1210 Cohort 1|"Induction phase: a) 400 mg on Day 1 and Day 8, 600 mg on Day 15; OR b) 600 mg on Day 1, 600 mg on Day 15~Maintenance phase: 900 mg on Day 29 and each month thereafter"
16420|NCT02598583|E2|Reported Event|ALXN1210 Cohort 2|"Induction phase: 600 mg on Day 1, 900 mg on Day 15~Maintenance phase: 1800 mg on Day 29 and each month thereafter"
16421|NCT02598583|E1|Reported Event|ALXN1210 Cohort 1|"Induction phase: a) 400 mg on Day 1 and Day 8, 600 mg on Day 15; OR b) 600 mg on Day 1, 600 mg on Day 15~Maintenance phase: 900 mg on Day 29 and each month thereafter"
16422|NCT02598128|B1|Baseline|Clinical Treatment Practice: Period A: Days -7 to -1|Period A was a 7-day baseline period. Patients received Peptamen 1.5 at their normal volume of enteral formula administration up to a maximum of 1000 mL per feeding. Current treatment practice was followed with normal use of oral pancreatic enzyme replacement therapy (PERT) during daily meals and nightly enteral feedings. A gastrointestinal symptom diary was completed for 7 consecutive days. Baseline Day -7 required a clinic visit followed by Days -6 to -1 at home.
16423|NCT02598128|P4|Participant Flow|Period C: Clinical Treatment Practice + RELiZORB (Days 12-20)|Period C was the open label clinical treatment period with RELiZORB. All patients used RELiZORB with Impact Peptide 1.5 at their normal volume as in Period A up to a maximum of 1000 mL per feeding. Patients were instructed to use the same daily dose and schedule of oral PERT taken in Period C as in Period A. There were no dietary restrictions. A gastrointestinal symptom diary was completed for 7 consecutive days. Patients received enteral feeding at home from Days 12 to 18 and returned to clinic for their end of study Day 19.
16424|NCT02598128|P3|Participant Flow|Crossover Period B: RELiZORB Then Placebo|Eligible subjects were randomized to RELiZORB then Placebo.
16425|NCT02598128|P2|Participant Flow|Crossover Period B: Placebo Then RELiZORB|Eligible subjects were randomized to Placebo then RELiZORB.
16426|NCT02598128|P1|Participant Flow|Period A: Clinical Treatment Practice (Days -7 to -1)|Period A was a 7-day baseline period. Patients received Peptamen 1.5 at their normal volume of enteral formula administration up to a maximum of 1000 mL per feeding. Current treatment practice was followed with normal use of oral pancreatic enzyme replacement therapy (PERT) during daily meals and nightly enteral feedings. A gastrointestinal symptom diary was completed for 7 consecutive days. Baseline Day -7 required a clinic visit followed by Days -6 to -1 at home.
16427|NCT02598128|O1|Outcome|Clinical Treatment Practice and Relizorb: Period C: Days 12-20|Period C was the open label clinical treatment period with RELiZORB. All patients received RELiZORB with Impact Peptide 1.5 at their normal volume as in Period A up to a maximum of 1000 mL per feeding. Patients were instructed to use the same daily dose and schedule of oral PERT taken in Period C as in Period A. There were no dietary restrictions. A gastrointestinal symptom diary was completed for 7 consecutive days. Patients received enteral feeding at home from Days 12 to 18 and returned to clinic for their end of study Day 19.
16428|NCT02598128|O2|Outcome|Control|Subjects receiving placebo at any time in the study.
16429|NCT02598128|O1|Outcome|RELiZORB|Subjects receiving RELiZORB at any time in the study.
16430|NCT02598128|O4|Outcome|Clinical Treatment Practice + RELiZORB: Period C: Days 12-20|Non-gastrointestinal adverse events during CTP+RELiZORB administration.
16431|NCT02598128|O3|Outcome|Crossover Period B: RELiZORB|Non-gastrointestinal adverse events during administration.
16432|NCT02598128|O2|Outcome|Crossover Period B: Placebo|Non-gastrointestinal adverse events during administration.
16433|NCT02598128|O1|Outcome|Clinical Treatment Practice: Period A: Days -7 to -1|Period A was a 7-day baseline period. Patients received Peptamen 1.5 at their normal volume of enteral formula administration up to a maximum of 1000 mL per feeding. Current treatment practice was followed with normal use of oral pancreatic enzyme replacement therapy (PERT) during daily meals and nightly enteral feedings. A gastrointestinal symptom diary was completed for 7 consecutive days. Baseline Day -7 required a clinic visit followed by Days -6 to -1 at home.
16434|NCT02598128|E3|Reported Event|Clinical Treatment Practice and Relizorb: Period C: Days 12-20|Period C was the open label clinical treatment period with RELiZORB. All patients received RELiZORB with Impact Peptide 1.5 at their normal volume as in Period A up to a maximum of 1000 mL per feeding. Patients were instructed to use the same daily dose and schedule of oral PERT taken in Period C as in Period A. There were no dietary restrictions. A gastrointestinal symptom diary was completed for 7 consecutive days. Patients received enteral feeding at home from Days 12 to 18 and returned to clinic for their end of study Day 19.
16455|NCT02597855|E2|Reported Event|Type 2 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
16435|NCT02598128|E2|Reported Event|Double-Blind Crossover: Period B: Days 1 to 11|Period B was the randomized, double-blind, placebo-controlled crossover period. Eligible patients were randomized in a 1:1 ratio to either Placebo-RELiZORB or RELiZORB-Placebo treatment sequences. On two separate administration Days 1 and 9, patients received 500 mL of Impact Peptide1.5 in clinic over a 4h period. Motility and acid suppression medications were discontinued 24h before arrival in clinic. No nocturnal feeding occurred between Days 1-2 and Days 9-10. During the home washout period Days 2 to 8, patients received Peptamen 1.5 for enteral nutrition up to a maximum volume of 1000 mL per feeding. Safety follow up calls were conducted on Days 2 and 10.
16436|NCT02598128|E1|Reported Event|Clinical Treatment Practice: Period A: Days -7 to -1|Period A was a 7-day baseline period. Patients received Peptamen 1.5 at their normal volume of enteral formula administration up to a maximum of 1000 mL per feeding. Current treatment practice was followed with normal use of oral pancreatic enzyme replacement therapy (PERT) during daily meals and nightly enteral feedings. A gastrointestinal symptom diary was completed for 7 consecutive days. Baseline Day -7 required a clinic visit followed by Days -6 to -1 at home.
16437|NCT02597907|B3|Baseline|Total|Total of all reporting groups
16438|NCT02597907|B2|Baseline|Aprepitant Plus Ramosetron|"aprepitant 80 mg ramosetron 0.3 mg~aprepitant: aprepitant 80 mg is given to all patients before surgery~Ramosetron: ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia"
16439|NCT02597907|B1|Baseline|Aprepitant Plus Palonosetron|"aprepitant 80 mg palonosetron 0.075 mg~aprepitant: aprepitant 80 mg is given to all patients before surgery~palonosetron: palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia"
16440|NCT02597907|P2|Participant Flow|Aprepitant Plus Palonosetron|"aprepitant 80 mg palonosetron 0.075 mg~aprepitant: aprepitant 80 mg is given to all patients before surgery~palonosetron: palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia"
16441|NCT02597907|P1|Participant Flow|Aprepitant Plus Ramosetron|"aprepitant 80 mg ramosetron 0.3 mg~aprepitant: aprepitant 80 mg is given to all patients before surgery~Ramosetron: ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia"
16442|NCT02597907|O2|Outcome|Aprepitant Plus Ramosetron|"aprepitant 80 mg ramosetron 0.3 mg~aprepitant: aprepitant 80 mg is given to all patients before surgery~Ramosetron: ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia"
16443|NCT02597907|O1|Outcome|Aprepitant Plus Palonosetron|"aprepitant 80 mg palonosetron 0.075 mg~aprepitant: aprepitant 80 mg is given to all patients before surgery~palonosetron: palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia"
16444|NCT02597907|E2|Reported Event|Aprepitant Plus Ramosetron|"aprepitant 80 mg ramosetron 0.3 mg~aprepitant: aprepitant 80 mg is given to all patients before surgery~Ramosetron: ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia"
16445|NCT02597907|E1|Reported Event|Aprepitant Plus Palonosetron|"aprepitant 80 mg palonosetron 0.075 mg~aprepitant: aprepitant 80 mg is given to all patients before surgery~palonosetron: palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia"
16446|NCT02597855|B3|Baseline|Total|Total of all reporting groups
16447|NCT02597855|B2|Baseline|Type 2 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
16448|NCT02597855|B1|Baseline|Type 1 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
16449|NCT02597855|P2|Participant Flow|Type 2 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate.~Aflibercept: Total 4 times of intravitreal aflibercept injection was performed~Indocyanine green angiography (intraveonus indocyanine green dye): At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
16450|NCT02597855|P1|Participant Flow|Type 1 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate.~Aflibercept: Total 4 times of intravitreal aflibercept injection was performed~Indocyanine green angiography (intraveonus indocyanine green dye): At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
16451|NCT02597855|O2|Outcome|Type 2 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
16452|NCT02597855|O1|Outcome|Type 1 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
16453|NCT02597855|O2|Outcome|Type 2 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
16454|NCT02597855|O1|Outcome|Type 1 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
16530|NCT02597049|O2|Outcome|0.75 mg Dulaglutide|Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.
16456|NCT02597855|E1|Reported Event|Type 1 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
16457|NCT02597582|B3|Baseline|Total|Total of all reporting groups
16458|NCT02597582|B2|Baseline|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
16459|NCT02597582|B1|Baseline|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
16460|NCT02597582|P2|Participant Flow|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
16461|NCT02597582|P1|Participant Flow|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
16462|NCT02597582|O2|Outcome|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
16463|NCT02597582|O1|Outcome|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
16464|NCT02597582|O2|Outcome|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
16465|NCT02597582|O1|Outcome|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
16466|NCT02597582|O2|Outcome|Conventional Neck Dissection|"The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.~Participants were asked to take a Voren enteric-microencapsulated (Diclofenac 50 mg/capsule) capsule 3 times a day for pain relief postoperatively. An additional capsule before sleep was allowed if persistent pain was told by the patient. When intolerable pain was complained in spite of oral analgesic, pethidine (meperidine 50 mg/ampule) injection was prescribed every 6 hours.~Neck dissection: The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
16467|NCT02597582|O1|Outcome|Ligusure Assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Participants were asked to take a Voren enteric-microencapsulated (Diclofenac 50 mg/capsule) capsule 3 times a day for pain relief postoperatively. An additional capsule before sleep was allowed if persistent pain was told by the patient. When intolerable pain was complained in spite of oral analgesic, pethidine (meperidine 50 mg/ampule) injection was prescribed every 6 hours.~Neck dissection: The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
16468|NCT02597582|O2|Outcome|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
16469|NCT02597582|O1|Outcome|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
16470|NCT02597582|O2|Outcome|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
16471|NCT02597582|O1|Outcome|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
16472|NCT02597582|O2|Outcome|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
16473|NCT02597582|O1|Outcome|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
16474|NCT02597582|E2|Reported Event|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
16531|NCT02597049|O1|Outcome|1.5 mg Dulaglutide|Dulaglutide 1.5 mg given SC QW for 24 weeks.
16475|NCT02597582|E1|Reported Event|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
16476|NCT02597543|B3|Baseline|Total|Total of all reporting groups
16477|NCT02597543|B2|Baseline|Normal Graft Function|"Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.~Regadenoson: For use in stress myocardial perfusion imaging.~Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.~Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
16478|NCT02597543|B1|Baseline|Nonspecific Allograft Dysfunction|"Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.~Regadenoson: For use in stress myocardial perfusion imaging.~Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.~Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
16479|NCT02597543|P2|Participant Flow|Normal Graft Function|"Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.~Regadenoson: For use in stress myocardial perfusion imaging.~Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.~Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
16480|NCT02597543|P1|Participant Flow|Nonspecific Allograft Dysfunction|"Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.~Regadenoson: For use in stress myocardial perfusion imaging.~Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.~Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
16481|NCT02597543|O2|Outcome|Normal Graft Function|"Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.~Regadenoson: For use in stress myocardial perfusion imaging.~Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.~Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
16482|NCT02597543|O1|Outcome|Nonspecific Allograft Dysfunction|"Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.~Regadenoson: For use in stress myocardial perfusion imaging.~Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.~Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
16483|NCT02597543|O2|Outcome|Normal Graft Function|"Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.~Regadenoson: For use in stress myocardial perfusion imaging.~Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.~Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
16484|NCT02597543|O1|Outcome|Nonspecific Allograft Dysfunction|"Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.~Regadenoson: For use in stress myocardial perfusion imaging.~Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.~Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
16485|NCT02597543|O2|Outcome|Normal Graft Function|"Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.~Regadenoson: For use in stress myocardial perfusion imaging.~Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.~Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
16486|NCT02597543|O1|Outcome|Nonspecific Allograft Dysfunction|"Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.~Regadenoson: For use in stress myocardial perfusion imaging.~Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.~Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
16487|NCT02597543|O2|Outcome|Normal Graft Function|"Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.~Regadenoson: For use in stress myocardial perfusion imaging.~Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.~Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
16488|NCT02597543|O1|Outcome|Nonspecific Allograft Dysfunction|"Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.~Regadenoson: For use in stress myocardial perfusion imaging.~Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.~Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
16532|NCT02597049|O3|Outcome|Placebo|Placebo given SC QW for 24 weeks.
16533|NCT02597049|O2|Outcome|0.75 mg Dulaglutide|Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.
16534|NCT02597049|O1|Outcome|1.5 mg Dulaglutide|Dulaglutide 1.5 mg given SC QW for 24 weeks.
16489|NCT02597543|O2|Outcome|Normal Graft Function|"Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.~Regadenoson: For use in stress myocardial perfusion imaging.~Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.~Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
16490|NCT02597543|O1|Outcome|Nonspecific Allograft Dysfunction|"Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.~Regadenoson: For use in stress myocardial perfusion imaging.~Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.~Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
16491|NCT02597543|O2|Outcome|Normal Graft Function|"Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.~Regadenoson: For use in stress myocardial perfusion imaging.~Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.~Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
16492|NCT02597543|O1|Outcome|Nonspecific Allograft Dysfunction|"Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.~Regadenoson: For use in stress myocardial perfusion imaging.~Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.~Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
16493|NCT02597543|E2|Reported Event|Normal Graft Function|"Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.~Regadenoson: For use in stress myocardial perfusion imaging.~Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.~Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
16494|NCT02597543|E1|Reported Event|Nonspecific Allograft Dysfunction|"Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.~Regadenoson: For use in stress myocardial perfusion imaging.~Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.~Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
16495|NCT02597049|B4|Baseline|Total|Total of all reporting groups
16496|NCT02597049|B3|Baseline|Placebo|Placebo given SC QW for 24 weeks.
16497|NCT02597049|B2|Baseline|0.75 mg Dulaglutide|Dulaglutide 0.75 mg given subcutaneously (SC) once a week (QW) for 24 weeks.
16498|NCT02597049|B1|Baseline|1.5 mg Dulaglutide|Dulaglutide 1.5 milligrams (mg) given SC QW for 24 weeks.
16499|NCT02597049|P3|Participant Flow|Placebo|Placebo given SC QW for 24 weeks.
16500|NCT02597049|P2|Participant Flow|0.75 mg Dulaglutide|Dulaglutide 0.75 mg given subcutaneously (SC) once a week (QW) for 24 weeks.
16501|NCT02597049|P1|Participant Flow|1.5 mg Dulaglutide|Dulaglutide 1.5 milligrams (mg) given SC QW for 24 weeks.
16502|NCT02597049|O3|Outcome|Placebo|Placebo given SC QW for 24 weeks.
16503|NCT02597049|O2|Outcome|0.75 mg Dulaglutide|Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.
16504|NCT02597049|O1|Outcome|1.5 mg Dulaglutide|Dulaglutide 1.5 mg given SC QW for 24 weeks.
16505|NCT02597049|O3|Outcome|Placebo|Placebo given SC QW for 24 weeks.
16506|NCT02597049|O2|Outcome|0.75 mg Dulaglutide|Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.
16507|NCT02597049|O1|Outcome|1.5 mg Dulaglutide|Dulaglutide 1.5 mg given SC QW for 24 weeks.
16508|NCT02597049|O3|Outcome|Placebo|Placebo given SC QW for 24 weeks.
16509|NCT02597049|O2|Outcome|0.75 mg Dulaglutide|Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.
16510|NCT02597049|O1|Outcome|1.5 mg Dulaglutide|Dulaglutide 1.5 mg given SC QW for 24 weeks.
16511|NCT02597049|O3|Outcome|Placebo|Placebo given SC QW for 24 weeks.
16512|NCT02597049|O2|Outcome|0.75 mg Dulaglutide|Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.
16513|NCT02597049|O1|Outcome|1.5 mg Dulaglutide|Dulaglutide 1.5 mg given SC QW for 24 weeks.
16514|NCT02597049|O3|Outcome|Placebo|Placebo given SC QW for 24 weeks.
16515|NCT02597049|O2|Outcome|0.75 mg Dulaglutide|Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.
16516|NCT02597049|O1|Outcome|1.5 mg Dulaglutide|Dulaglutide 1.5 mg given SC QW for 24 weeks.
16517|NCT02597049|O3|Outcome|Placebo|Placebo given SC QW for 24 weeks.
16518|NCT02597049|O2|Outcome|0.75 mg Dulaglutide|Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.
16519|NCT02597049|O1|Outcome|1.5 mg Dulaglutide|Dulaglutide 1.5 mg given SC QW for 24 weeks.
16520|NCT02597049|O3|Outcome|Placebo|Placebo given SC QW for 24 weeks.
16521|NCT02597049|O2|Outcome|0.75 mg Dulaglutide|Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.
16522|NCT02597049|O1|Outcome|1.5 mg Dulaglutide|Dulaglutide 1.5 mg given SC QW for 24 weeks.
16523|NCT02597049|O3|Outcome|Placebo|Placebo given SC QW for 24 weeks.
16524|NCT02597049|O2|Outcome|0.75 mg Dulaglutide|Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.
16525|NCT02597049|O1|Outcome|1.5 mg Dulaglutide|Dulaglutide 1.5 mg given SC QW for 24 weeks.
16526|NCT02597049|O3|Outcome|Placebo|Placebo given SC QW for 24 weeks.
16527|NCT02597049|O2|Outcome|0.75 mg Dulaglutide|Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.
16528|NCT02597049|O1|Outcome|1.5 mg Dulaglutide|Dulaglutide 1.5 mg given SC QW for 24 weeks.
16529|NCT02597049|O3|Outcome|Placebo|Placebo given SC QW for 24 weeks.
16537|NCT02597049|E1|Reported Event|1.5 mg Dulaglutide|Dulaglutide 1.5 milligrams (mg) given SC QW for 24 weeks.
16538|NCT02596958|B1|Baseline|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
16539|NCT02596958|P1|Participant Flow|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current summary of product characteristics (SmPC).
16540|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
16541|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
16542|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
16543|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
16544|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
16545|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
16546|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
16547|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
16548|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
16549|NCT02596958|E1|Reported Event|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
16550|NCT02596945|B1|Baseline|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
16551|NCT02596945|P1|Participant Flow|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the Summary of Product Characteristics (SmPC) were observed for a period of 9 months.
16552|NCT02596945|O1|Outcome|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
16553|NCT02596945|O1|Outcome|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
16554|NCT02596945|O1|Outcome|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
16555|NCT02596945|E1|Reported Event|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
16556|NCT02596867|B1|Baseline|Open Label Single Arm, Drug Propanolol|"2 subjects enrolled and received the experimental drug~propanolol: Participants took 1.5 mg/kg/day propranolol, twice daily for 3 weeks until surgical resection of the breast tumor is performed"
16557|NCT02596867|P1|Participant Flow|Open Label Single Arm, Drug Propanolol|2 subjects enrolled and received the experimental drug propanolol: Participants took 1.5 mg/kg/day propranolol, twice daily for 3 weeks until surgical resection of the breast tumor is performed
16558|NCT02596867|O1|Outcome|Open Label Single Arm, Drug Propanolol|"2 subjects enrolled and received the experimental drug~propanolol: Participants took 1.5 mg/kg/day propranolol, twice daily for 3 weeks until surgical resection of the breast tumor is performed~Both patients reported no AEs due to treatment during treatment phase"
16559|NCT02596867|O1|Outcome|Open Label Single Arm, Drug Propanolol|We tested the efficacy of propranolol on two patients with breast cancer by recording % reduction of Ki67
16560|NCT02596867|E1|Reported Event|Open Label Single Arm, Drug Propanolol|"all subjects will receive the experimental drug~propanolol: Participants will take 1.5 mg/kg/day propranolol, twice daily for 3 weeks until surgical resection of the breast tumor is performed"
16561|NCT02596854|B1|Baseline|Neurological MRI|"Image acquired for post processing with synthetic software~Neurological MRI: Neurological MRI image collection"
16562|NCT02596854|P1|Participant Flow|Neurological MRI|"Image acquired for post processing with synthetic software~Neurological MRI: Neurological MRI image collection"
16563|NCT02596854|O1|Outcome|Neurological MRI|"Image acquired for post processing with synthetic software~Neurological MRI: Neurological MRI image collection"
16564|NCT02596854|E1|Reported Event|Neurological MRI|"Image acquired for post processing with synthetic software~Neurological MRI: Neurological MRI image collection"
16565|NCT02596620|B3|Baseline|Total|Total of all reporting groups
16566|NCT02596620|B2|Baseline|Triple Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily; amoxicillin (Amolin)(500 mg) 2 tablets twice daily and levofloxacin(Cravit)(500 mg), 1 tablet once daily for 10 days~Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms~Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm~Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm"
16567|NCT02596620|B1|Baseline|Sequential Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily, amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 5 days followed by esomeprazole (Nexium) (40 mg) twice daily, levofloxacin(Cravit)(500 mg), 1 tablet once daily and metronidazole (Flagyl)(250 mg) 2 tablets three times daily for 5 days~Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms~Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm~Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm~Flagyl: Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm"
16568|NCT02596620|P2|Participant Flow|Triple Therapy|levofloxacin 500 mg qd, amoxicillin 1 g bid, and esomeprazole 40 mg bid
16569|NCT02596620|P1|Participant Flow|Sequential Therapy|esomeprazole 40 mg bid and amoxicillin 1 g bid for 5 days, followed by esomeprazole 40 mg bid, levofloxacin 500 mg qd, and metronidazole 500 mg tid, for 5 days
16570|NCT02596620|O2|Outcome|Triple Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily; amoxicillin (Amolin)(500 mg) 2 tablets twice daily and levofloxacin(Cravit)(500 mg), 1 tablet once daily for 10 days~Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms~Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm~Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm"
16571|NCT02596620|O1|Outcome|Sequential Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily, amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 5 days followed by esomeprazole (Nexium) (40 mg) twice daily, levofloxacin(Cravit)(500 mg), 1 tablet once daily and metronidazole (Flagyl)(250 mg) 2 tablets three times daily for 5 days~Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms~Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm~Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm~Flagyl: Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm"
16572|NCT02596620|E2|Reported Event|Triple Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily; amoxicillin (Amolin)(500 mg) 2 tablets twice daily and levofloxacin(Cravit)(500 mg), 1 tablet once daily for 10 days~Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms~Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm~Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm"
16573|NCT02596620|E1|Reported Event|Sequential Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily, amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 5 days followed by esomeprazole (Nexium) (40 mg) twice daily, levofloxacin(Cravit)(500 mg), 1 tablet once daily and metronidazole (Flagyl)(250 mg) 2 tablets three times daily for 5 days~Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms~Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm~Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm~Flagyl: Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm"
16574|NCT02596451|B4|Baseline|Total|Total of all reporting groups
16575|NCT02596451|B3|Baseline|Placebo|Vehicle gel (Glenmark Pharmaceuticals Ltd)
16576|NCT02596451|B2|Baseline|Reference|Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc)
16577|NCT02596451|B1|Baseline|Test|Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd)
16578|NCT02596451|P3|Participant Flow|Placebo|Vehicle gel (Glenmark Pharmaceuticals Ltd)
16579|NCT02596451|P2|Participant Flow|Reference|Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc)
16580|NCT02596451|P1|Participant Flow|Test|Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd)
16581|NCT02596451|O2|Outcome|Reference|Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc)
16582|NCT02596451|O1|Outcome|Test|Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd)
16583|NCT02596451|E3|Reported Event|Placebo|Vehicle gel (Glenmark Pharmaceuticals Ltd)
16584|NCT02596451|E2|Reported Event|Reference|Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc)
16585|NCT02596451|E1|Reported Event|Test|Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd)
16586|NCT02596321|B3|Baseline|Total|Total of all reporting groups
16587|NCT02596321|B2|Baseline|Placebo Tablet|"Placebo tablet~Placebo: Placebo tablet"
16588|NCT02596321|B1|Baseline|Mitizax ALK HDM Tablet|"Standardised allergen extract from the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae developmental unit, dose standard for ALK HDM tablets (12DU)~Mitizax: Allergen extract"
16589|NCT02596321|P2|Participant Flow|Placebo Tablet|"Placebo tablet~Placebo: Placebo tablet"
16590|NCT02596321|P1|Participant Flow|Mitizax ALK HDM Tablet|"Standardised allergen extract from the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae developmental unit, dose standard for ALK HDM tablets (12DU)~Mitizax: Allergen extract"
16591|NCT02596321|O2|Outcome|Placebo Tablet|"Placebo tablet~Placebo: Placebo tablet"
16592|NCT02596321|O1|Outcome|Mitizax ALK HDM Tablet|"Standardised allergen extract from the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae developmental unit, dose standard for ALK HDM tablets (12DU)~Mitizax: Allergen extract"
16593|NCT02596321|O2|Outcome|Placebo Tablet|"Placebo tablet~Placebo: Placebo tablet"
16594|NCT02596321|O1|Outcome|Mitizax ALK HDM Tablet|"Standardised allergen extract from the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae developmental unit, dose standard for ALK HDM tablets (12DU)~Mitizax: Allergen extract"
16595|NCT02596321|O2|Outcome|Placebo Tablet|"Placebo tablet~Placebo: Placebo tablet"
16596|NCT02596321|O1|Outcome|Mitizax ALK HDM Tablet|"Standardised allergen extract from the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae developmental unit, dose standard for ALK HDM tablets (12DU)~Mitizax: Allergen extract"
16597|NCT02596321|O2|Outcome|Placebo Tablet|"Placebo tablet~Placebo: Placebo tablet"
16598|NCT02596321|O1|Outcome|Mitizax ALK HDM Tablet|"Standardised allergen extract from the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae developmental unit, dose standard for ALK HDM tablets (12DU)~Mitizax: Allergen extract"
16599|NCT02596321|E2|Reported Event|Placebo Tablet|"Placebo tablet~Placebo: Placebo tablet"
16600|NCT02596321|E1|Reported Event|Mitizax ALK HDM Tablet|"Standardised allergen extract from the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae developmental unit, dose standard for ALK HDM tablets (12DU)~Mitizax: Allergen extract"
16601|NCT02596022|B3|Baseline|Total|Total of all reporting groups
16602|NCT02596022|B2|Baseline|CI-581b First, Followed by CI-581a|"Administration of CI-581b followed 2 weeks later by CI-581a~CI-581a: a 50 minute infusion 24 hours prior to cocaine self-administration session~CI-581b: a 50 minute infusion 24 hours prior to cocaine self-administration session"
16603|NCT02596022|B1|Baseline|CI-581a First, Followed by CI-581b|"Administration of CI-581a followed 2 weeks later by CI-581b~CI-581a: a 50 minute infusion 24 hours prior to cocaine self-administration session~CI-581b: a 50 minute infusion 24 hours prior to cocaine self-administration session"
16604|NCT02596022|P2|Participant Flow|CI-581b First, Followed by CI-581a|"Administration of CI-581b followed 2 weeks later by CI-581a~CI-581a: a 50 minute infusion 24 hours prior to cocaine self-administration session~CI-581b: a 50 minute infusion 24 hours prior to cocaine self-administration session"
16605|NCT02596022|P1|Participant Flow|CI-581a First, Followed by CI-581b|"Administration of CI-581a followed 2 weeks later by CI-581b~CI-581a: a 50 minute infusion 24 hours prior to cocaine self-administration session~CI-581b: a 50 minute infusion 24 hours prior to cocaine self-administration session"
16606|NCT02596022|O2|Outcome|CI-581b|CI-581a: a 50 minute infusion 24 hours prior to cocaine self-administration session
16607|NCT02596022|O1|Outcome|CI-581a|CI-581a: a 50 minute infusion 24 hours prior to cocaine self-administration session
16608|NCT02596022|E2|Reported Event|CI-581b First, Followed by CI-581a|"Administration of CI-581b followed 2 weeks later by CI-581a~CI-581a: a 50 minute infusion 24 hours prior to cocaine self-administration session~CI-581b: a 50 minute infusion 24 hours prior to cocaine self-administration session"
16609|NCT02596022|E1|Reported Event|CI-581a First, Followed by CI-581b|"Administration of CI-581a followed 2 weeks later by CI-581b~CI-581a: a 50 minute infusion 24 hours prior to cocaine self-administration session~CI-581b: a 50 minute infusion 24 hours prior to cocaine self-administration session"
16610|NCT02595567|B1|Baseline|ITPC|Patients in the ITPC (indwelling tunneled pleural catheter) arm will have and ITPC placed for management of recurrent pleural effusion due to liver disease (hepatic hydrothorax). These patients will have undergone at least one prior thoracentesis that has resulted in improvement in shortness of breath. Pleural fluid studies will demonstrate a transudative process, also consistent with hepatic hydrothorax. All patients will have undergone evaluation by the Hepatology service and will have been deemed eligible for additional treatment, such as liver transplant or TIPS (transjugular intrahepatic portosystemic shunt) procedures.
16611|NCT02595567|P1|Participant Flow|ITPC|Patients in the ITPC (indwelling tunneled pleural catheter) arm will consist of patients with hepatic hydrothorax who have undergone at least one prior thoracentesis which has resulted in improvement in shortness of breath. The fluid characteristics will be consistent with a transudative pleural effusion. Patients in this group will also have been assessed by the Hepatology service and deemed candidates for additional therapy, such as liver transplant, or TIPS (transjugular intrahepatic portosystemic shunt).
16612|NCT02595567|O1|Outcome|ITPC|Patients in the ITPC (indwelling tunneled pleural catheter) arm will consist of patients with hepatic hydrothorax who have undergone at least one prior thoracentesis which has resulted in improvement in shortness of breath. The fluid characteristics will be consistent with a transudative pleural effusion. Patients in this group will also have been assessed by the Hepatology service and deemed candidates for additional therapy, such as liver transplant, or TIPS (transjugular intrahepatic portosystemic shunt).
16613|NCT02595567|E1|Reported Event|ITPC|Patients in the ITPC (indwelling tunneled pleural catheter) arm will consist of patients with hepatic hydrothorax who have undergone at least one prior thoracentesis which has resulted in improvement in shortness of breath. The fluid characteristics will be consistent with a transudative pleural effusion. Patients in this group will also have been assessed by the Hepatology service and deemed candidates for additional therapy, such as liver transplant, or TIPS (transjugular intrahepatic portosystemic shunt).
16614|NCT02595502|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens throughout the duration of the study.
16615|NCT02595502|P2|Participant Flow|Senofilcon A/Delefilcon A/Senofilcon A|Subjects that wore the senofilcon A lens first, the delefilcon A lens second and then wore the senofilcon A lens again, third.
16661|NCT02592655|E2|Reported Event|Windlass Tourniquet|One or two windlass tourniquets applied as needed to achieve study objectives.
16616|NCT02595502|P1|Participant Flow|Delefilcon A /Senofilcon A/Delefilcon A|Subjects that wore the delefilcon A lens first, the senofilcon A lens second and then wore the delefilcon A lens again, third.
16617|NCT02595502|O2|Outcome|Senofilcon A|Subjects that wore the senofilcon A lens in any of the 3 periods during the course of this study.
16618|NCT02595502|O1|Outcome|Delefilcon A|Subjects that wore the delefilcon A lens in any of the 3 periods during the course of this study.
16619|NCT02595502|E2|Reported Event|Senofilcon A|Subjects that wore the senofilcon A lens in any of the 3 periods during the course of this study.
16620|NCT02595502|E1|Reported Event|Delefilcon A|Subjects that wore the delefilcon A lens in any of the 3 periods during the course of this study.
16621|NCT02595450|B1|Baseline|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
16622|NCT02595450|P1|Participant Flow|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
16623|NCT02595450|O1|Outcome|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
16624|NCT02595450|O1|Outcome|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
16625|NCT02595450|O1|Outcome|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
16626|NCT02595450|E1|Reported Event|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
16627|NCT02594826|B3|Baseline|Total|Total of all reporting groups
16628|NCT02594826|B2|Baseline|General Health Education Control|"General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.~General health education control: General health and cancer education"
16629|NCT02594826|B1|Baseline|Culturally Appropriate Intervention|"Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.~Culturally appropriate intervention: Church-based educational intervention combined with navigation assistance"
16630|NCT02594826|P2|Participant Flow|General Health Education Control|"General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.~General health education control: General health and cancer education"
16631|NCT02594826|P1|Participant Flow|Culturally Appropriate Intervention|"Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.~Culturally appropriate intervention: Church-based educational intervention combined with navigation assistance"
16632|NCT02594826|O2|Outcome|General Health Education Control|"General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.~General health education control: General health and cancer education"
16633|NCT02594826|O1|Outcome|Culturally Appropriate Intervention|"Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.~Culturally appropriate intervention: Church-based educational intervention combined with navigation assistance"
16634|NCT02594826|E2|Reported Event|General Health Education Control|"General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.~General health education control: General health and cancer education"
16635|NCT02594826|E1|Reported Event|Culturally Appropriate Intervention|"Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.~Culturally appropriate intervention: Church-based educational intervention combined with navigation assistance"
16636|NCT02593773|B1|Baseline|Interferon γ-1b|SC ACTIMMUNE® TIW for a total of 26 weeks. The study drug dose was escalated on a weekly basis over the first 4 weeks of treatment (from 10 μg/m² to 25, 50, and 100 μg/m²), based on tolerability, with all participants on a stable tolerated dose by Week 13. Dose may have been reduced, interrupted, or held based on tolerability thereafter.
16637|NCT02593773|P1|Participant Flow|Interferon γ-1b|Subcutaneous (SC) ACTIMMUNE® 3 times a week (TIW) for a total of 26 weeks. The study drug dose was escalated on a weekly basis over the first 4 weeks of treatment (from 10 μg/m² to 25, 50, and 100 μg/m²), based on tolerability, with all participants on a stable tolerated dose by Week 13. Dose may have been reduced, interrupted, or held based on tolerability thereafter.
16638|NCT02593773|O1|Outcome|Interferon γ-1b|SC ACTIMMUNE® TIW for a total of 26 weeks. The study drug dose was escalated on a weekly basis over the first 4 weeks of treatment (from 10 μg/m² to 25, 50, and 100 μg/m²), based on tolerability, with all participants on a stable tolerated dose by Week 13. Dose may have been reduced, interrupted, or held based on tolerability thereafter.
16639|NCT02593773|O1|Outcome|Interferon γ-1b|SC ACTIMMUNE® TIW for a total of 26 weeks. The study drug dose was escalated on a weekly basis over the first 4 weeks of treatment (from 10 μg/m² to 25, 50, and 100 μg/m²), based on tolerability, with all participants on a stable tolerated dose by Week 13. Dose may have been reduced, interrupted, or held based on tolerability thereafter.
16640|NCT02593773|O1|Outcome|Interferon γ-1b|SC ACTIMMUNE® TIW for a total of 26 weeks. The study drug dose was escalated on a weekly basis over the first 4 weeks of treatment (from 10 μg/m² to 25, 50, and 100 μg/m²), based on tolerability, with all participants on a stable tolerated dose by Week 13. Dose may have been reduced, interrupted, or held based on tolerability thereafter.
16641|NCT02593773|O1|Outcome|Interferon γ-1b|SC ACTIMMUNE® TIW for a total of 26 weeks. The study drug dose was escalated on a weekly basis over the first 4 weeks of treatment (from 10 μg/m² to 25, 50, and 100 μg/m²), based on tolerability, with all participants on a stable tolerated dose by Week 13. Dose may have been reduced, interrupted, or held based on tolerability thereafter.
16642|NCT02593773|O1|Outcome|Interferon γ-1b|SC ACTIMMUNE® TIW for a total of 26 weeks. The study drug dose was escalated on a weekly basis over the first 4 weeks of treatment (from 10 μg/m² to 25, 50, and 100 μg/m²), based on tolerability, with all participants on a stable tolerated dose by Week 13. Dose may have been reduced, interrupted, or held based on tolerability thereafter.
16643|NCT02593773|O1|Outcome|Interferon γ-1b|SC ACTIMMUNE® TIW for a total of 26 weeks. The study drug dose was escalated on a weekly basis over the first 4 weeks of treatment (from 10 μg/m² to 25, 50, and 100 μg/m²), based on tolerability, with all participants on a stable tolerated dose by Week 13. Dose may have been reduced, interrupted, or held based on tolerability thereafter.
16644|NCT02593773|O1|Outcome|Interferon γ-1b|SC ACTIMMUNE® TIW for a total of 26 weeks. The study drug dose was escalated on a weekly basis over the first 4 weeks of treatment (from 10 μg/m² to 25, 50, and 100 μg/m²), based on tolerability, with all participants on a stable tolerated dose by Week 13. Dose may have been reduced, interrupted, or held based on tolerability thereafter.
16645|NCT02593773|E1|Reported Event|Interferon γ-1b|SC ACTIMMUNE® TIW for a total of 26 weeks. The study drug dose was escalated on a weekly basis over the first 4 weeks of treatment (from 10 μg/m² to 25, 50, and 100 μg/m²), based on tolerability, with all participants on a stable tolerated dose by Week 13. Dose may have been reduced, interrupted, or held based on tolerability thereafter.
16646|NCT02592655|B3|Baseline|Total|Total of all reporting groups
16647|NCT02592655|B2|Baseline|Two Windlass Tourniquets|Baseline characteristics for participants who had a second windlass tourniquet applied immediately proximal to the first. Meaning that a single windlass tourniquet did not appear effective.
16648|NCT02592655|B1|Baseline|One Windlass Tourniquet|Baseline characteristics for participants that received only one windlass tourniquet.
16649|NCT02592655|P1|Participant Flow|All Participants|"Each subject has been randomly allocated to a sequence of interventions. Pneumatic tourniquet with a 10 cm (4 inch) wide cylindrical cuff typically used in surgical settings, and is representative of best outcome.~Windlass Tourniquet: The Special Operations Forces Tactical Tourniquet Wide (SOFTT-W) is 3.8 cm (1.5 inch) in width. The SOFTT-W is representative of the typical emergency tourniquet. In accordance with current prehospital guidelines: If a single windlass tourniquet not effective then a second windlass tourniquet will be applied immediately proximal to the first.~Tourniquet Tape 10 cm wide and Tourniquet Tape 5 cm wide are elastic adhesive tape tourniquets.~5 cm tape was discontinued after the 4th participant. Once stretched the tape was too narrow for sufficient overlap. Because the overlap was not sufficient the edges began to roll. This would create an unacceptably narrow band if left in place longer than the prescribed time."
16650|NCT02592655|O5|Outcome|Tourniquet Tape 5 cm|Tourniquet Tape 5 cm (2 inch) width. Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the tourniquet tape application. If no flow is observed for 1 sustained minute then the occlusion is considered successful.
16651|NCT02592655|O4|Outcome|Two Windlass Tourniquets|Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of the two windlass tourniquets to the middle upper thigh. If no flow is observed by the investigators for 1 sustained minute then it is considered successful occlusion.
16652|NCT02592655|O3|Outcome|One Windlass Tourniquet|Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of one windlass tourniquet to the middle upper thigh. If no flow is observed by the investigators for 1 sustained minute then it is considered successful occlusion.
16653|NCT02592655|O2|Outcome|Pneumatic Tourniquet|Automatic pneumatic tourniquet with a 10 cm (4 inch) wide cuff applied to the upper half of the participants thigh. Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the tourniquet tape application. If no flow is observed for 1 sustained minute then the occlusion is considered successful.
16654|NCT02592655|O1|Outcome|Tourniquet Tape 10 cm|Tourniquet Tape 10 cm (4 inch) width. Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the tourniquet tape application. If no flow is observed for 1 sustained minute then the occlusion is considered successful.
16655|NCT02592655|O4|Outcome|Two Windlass Tourniquets|Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of two windlass tourniquets to the middle upper thigh. If no flow is observed for 1 sustained minute then it is considered successful occlusion. A still image is then saved for later evaluation by the blinded outcome assessor.
16656|NCT02592655|O3|Outcome|One Windlass Tourniquet|Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of a one windlass tourniquet to the middle upper thigh. If no flow is observed for 1 sustained minute then it is considered successful occlusion. A still image is then saved for later evaluation by the blinded outcome assessor.
16657|NCT02592655|O2|Outcome|Pneumatic Tourniquet|Automatic pneumatic tourniquet with a 10 cm (4 inch) wide cuff applied to the upper half of the participants thigh. Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the tourniquet tape application. If no flow is observed for 1 sustained minute then the occlusion is considered successful. A still image is then saved for later evaluation by the blinded outcome assessor.
16658|NCT02592655|O1|Outcome|Tourniquet Tape 10 cm|Tourniquet Tape 10 cm (4 inch) width. Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the tourniquet tape application. If no flow is observed for 1 sustained minute then the occlusion is considered successful. A still image is then saved for later evaluation by the blinded outcome assessor.
16659|NCT02592655|E4|Reported Event|Tourniquet Tape 10 cm|Tourniquet Tape, 10 cm (4 inch) width. A highly elastic transparent occlusive material that can create circumferential pressure when stretched and wrapped around a limb.
16660|NCT02592655|E3|Reported Event|Tourniquet Tape 5 cm|Tourniquet Tape 5 cm (2 inch) width. A highly elastic transparent occlusive material that can create circumferential pressure when stretched and wrapped around a limb.
16662|NCT02592655|E1|Reported Event|Pneumatic Tourniquet|The Automatic Tourniquet System (ATS) 1500 by Zimmer (formerly Aspen Labs) was used with a 10 cm (4 inch) wide pneumatic cuff.
16663|NCT02591537|B3|Baseline|Total|Total of all reporting groups
16664|NCT02591537|B2|Baseline|Standard Tegaderm Dressing|Standard Tegaderm Dressing will be applied.
16665|NCT02591537|B1|Baseline|OxyGenesys Dissolved Oxygen Dressing|"OxyGenesys Dissolved Oxygen Dressing will be applied.~OxyGenesys Dissolved Oxygen Dressing: 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing."
16666|NCT02591537|P2|Participant Flow|Standard Tegaderm Dressing|Standard Tegaderm Dressing will be applied.
16667|NCT02591537|P1|Participant Flow|OxyGenesys Dissolved Oxygen Dressing|"OxyGenesys Dissolved Oxygen Dressing will be applied.~OxyGenesys Dissolved Oxygen Dressing: 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing."
16668|NCT02591537|O2|Outcome|Standard Tegaderm Dressing|Standard Tegaderm Dressing will be applied.
16669|NCT02591537|O1|Outcome|OxyGenesys Dissolved Oxygen Dressing|"OxyGenesys Dissolved Oxygen Dressing will be applied.~OxyGenesys Dissolved Oxygen Dressing: 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing."
16670|NCT02591537|O2|Outcome|Standard Tegaderm Dressing|Standard Tegaderm Dressing will be applied.
16671|NCT02591537|O1|Outcome|OxyGenesys Dissolved Oxygen Dressing|"OxyGenesys Dissolved Oxygen Dressing will be applied.~OxyGenesys Dissolved Oxygen Dressing: 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing."
16672|NCT02591537|O2|Outcome|Standard Tegaderm Dressing|Standard Tegaderm Dresssing will be applied.
16673|NCT02591537|O1|Outcome|OxyGenesys Dissolved Oxygen Dressing|"OxyGenesys Dissolved Oxygen Dressing will be applied.~OxyGenesys Dissolved Oxygen Dressing: 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing."
16674|NCT02591537|O2|Outcome|Standard Tegaderm Dressing|Standard Tegaderm Dressing will be applied.
16675|NCT02591537|O1|Outcome|OxyGenesys Dissolved Oxygen Dressing|"OxyGenesys Dissolved Oxygen Dressing will be applied.~OxyGenesys Dissolved Oxygen Dressing: 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing."
16676|NCT02591537|O2|Outcome|Standard Tegaderm Dressing|Standard Tegaderm Dressing will be applied.
16677|NCT02591537|O1|Outcome|OxyGenesys Dissolved Oxygen Dressing|"OxyGenesys Dissolved Oxygen Dressing will be applied.~OxyGenesys Dissolved Oxygen Dressing: 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing."
16678|NCT02591537|O2|Outcome|Standard Tegaderm Dressing|Standard Tegaderm Dressing will be applied.
16679|NCT02591537|O1|Outcome|OxyGenesys Dissolved Oxygen Dressing|"OxyGenesys Dissolved Oxygen Dressing will be applied.~OxyGenesys Dissolved Oxygen Dressing: 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing."
16680|NCT02591537|O2|Outcome|Standard Tegaderm Dressing|Standard Tegaderm Dressing will be applied.
16681|NCT02591537|O1|Outcome|OxyGenesys Dissolved Oxygen Dressing|"OxyGenesys Dissolved Oxygen Dressing will be applied.~OxyGenesys Dissolved Oxygen Dressing: 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing."
16682|NCT02591537|O2|Outcome|Standard Tegaderm Dressing|Standard Tegaderm Dressing will be applied.
16683|NCT02591537|O1|Outcome|OxyGenesys Dissolved Oxygen Dressing|"OxyGenesys Dissolved Oxygen Dressing will be applied.~OxyGenesys Dissolved Oxygen Dressing: 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing."
16684|NCT02591537|E2|Reported Event|Standard Tegaderm Dressing|Standard Tegaderm Dressing will be applied.
16685|NCT02591537|E1|Reported Event|OxyGenesys Dissolved Oxygen Dressing|"OxyGenesys Dissolved Oxygen Dressing will be applied.~OxyGenesys Dissolved Oxygen Dressing: 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing."
16686|NCT02591290|B1|Baseline|Menactra® Vaccine|Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval.
16687|NCT02591290|P1|Participant Flow|Menactra® Vaccine|Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval.
16688|NCT02591290|O1|Outcome|Menactra® Vaccine|Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval.
16689|NCT02591290|O1|Outcome|Menactra® Vaccine|Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval.
16690|NCT02591290|O1|Outcome|Menactra® Vaccine|Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval.
16691|NCT02591290|E1|Reported Event|Menactra® Vaccine|Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval.
16692|NCT02591238|B5|Baseline|Total|Total of all reporting groups
16693|NCT02591238|B4|Baseline|Ismoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
16694|NCT02591238|B3|Baseline|IIsmoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
16695|NCT02591238|B2|Baseline|IIInon-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
16696|NCT02591238|B1|Baseline|IVnon-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
16697|NCT02591238|P4|Participant Flow|I Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
16698|NCT02591238|P3|Participant Flow|II Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
16699|NCT02591238|P2|Participant Flow|III Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
16700|NCT02591238|P1|Participant Flow|IV Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
16701|NCT02591238|O4|Outcome|I Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
16702|NCT02591238|O3|Outcome|II Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
16703|NCT02591238|O2|Outcome|III Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
16704|NCT02591238|O1|Outcome|IV Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
25841|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
16705|NCT02591238|O4|Outcome|I Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
16706|NCT02591238|O3|Outcome|II Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
16707|NCT02591238|O2|Outcome|III Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
16708|NCT02591238|O1|Outcome|IV Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
16709|NCT02591238|O4|Outcome|I Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
16710|NCT02591238|O3|Outcome|II Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
16711|NCT02591238|O2|Outcome|III Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
16712|NCT02591238|O1|Outcome|IV Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
16713|NCT02591238|O4|Outcome|I Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
16714|NCT02591238|O3|Outcome|II Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
16715|NCT02591238|O2|Outcome|III Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
16716|NCT02591238|O1|Outcome|IV Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
16717|NCT02591238|O4|Outcome|I Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
16718|NCT02591238|O3|Outcome|II Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
16719|NCT02591238|O2|Outcome|III Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
16720|NCT02591238|O1|Outcome|IV Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
16721|NCT02591238|O4|Outcome|I Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
16722|NCT02591238|O3|Outcome|II Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
16723|NCT02591238|O2|Outcome|III Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
16724|NCT02591238|O1|Outcome|IV Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
16725|NCT02591238|E4|Reported Event|Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
16726|NCT02591238|E3|Reported Event|Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
16727|NCT02591238|E2|Reported Event|Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
16728|NCT02591238|E1|Reported Event|Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
16729|NCT02591056|B1|Baseline|Erchonia Verju Laser + Green PRESS 8|"All subjects receive 12 combination treatments over 6 weeks (two per week) with the Erchonia® Verju™ Laser and the Green PRESS 8 devices simultaneously.~Erchonia Verju Laser + Green PRESS 8: There are 12 combined procedure administrations with the Erchonia® Verju™ Laser and the Green PRESS 8 simultaneously across 6 weeks: 2 procedures per week. For each procedure administration, the Erchonia Verju is applied to the midsection for 30 minutes: 15 minutes front and 15 minutes back, followed by administration of the Green PRESS 8 to the midsection for 30 minutes. All subjects receive the combination Erchonia Verju Laser + Green PRESS 8 treatment for all 12 procedure administrations."
16730|NCT02591056|P1|Participant Flow|Erchonia Verju Laser + Green PRESS 8|"All subjects receive 12 combination treatments over 6 weeks (two per week) with the Erchonia® Verju™ Laser and the Green PRESS 8 devices simultaneously.~Erchonia Verju Laser + Green PRESS 8: There are 12 combined procedure administrations with the Erchonia® Verju™ Laser and the Green PRESS 8 simultaneously across 6 weeks: 2 procedures per week. For each procedure administration, the Erchonia Verju is applied to the midsection for 30 minutes: 15 minutes front and 15 minutes back, followed by administration of the Green PRESS 8 to the midsection for 30 minutes. All subjects receive the combination Erchonia Verju Laser + Green PRESS 8 treatment for all 12 procedure administrations."
16731|NCT02591056|O1|Outcome|Erchonia Verju Laser + Green PRESS 8|"All subjects receive 12 combination treatments over 6 weeks (two per week) with the Erchonia® Verju™ Laser and the Green PRESS 8 devices simultaneously.~Erchonia Verju Laser + Green PRESS 8: There are 12 combined procedure administrations with the Erchonia® Verju™ Laser and the Green PRESS 8 simultaneously across 6 weeks: 2 procedures per week. For each procedure administration, the Erchonia Verju is applied to the midsection for 30 minutes: 15 minutes front and 15 minutes back, followed by administration of the Green PRESS 8 to the midsection for 30 minutes. All subjects receive the combination Erchonia Verju Laser + Green PRESS 8 treatment for all 12 procedure administrations."
16732|NCT02591056|E1|Reported Event|Erchonia Verju Laser + Green PRESS 8|"All subjects receive 12 combination treatments over 6 weeks (two per week) with the Erchonia® Verju™ Laser and the Green PRESS 8 devices simultaneously.~Erchonia Verju Laser + Green PRESS 8: There are 12 combined procedure administrations with the Erchonia® Verju™ Laser and the Green PRESS 8 simultaneously across 6 weeks: 2 procedures per week. For each procedure administration, the Erchonia Verju is applied to the midsection for 30 minutes: 15 minutes front and 15 minutes back, followed by administration of the Green PRESS 8 to the midsection for 30 minutes. All subjects receive the combination Erchonia Verju Laser + Green PRESS 8 treatment for all 12 procedure administrations."
16733|NCT02590939|B3|Baseline|Total|Total of all reporting groups
16734|NCT02590939|B2|Baseline|Sham Device|"60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device~CEFALY Placebo: Placebo external trigeminal nerve stimulation"
16735|NCT02590939|B1|Baseline|Active Device|"60 minutes of active external trigeminal nerve stimulation with a CEFALY device~CEFALY Active: Active external trigeminal nerve stimulation"
16736|NCT02590939|P2|Participant Flow|Sham Device|"60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device~CEFALY Placebo: Placebo external trigeminal nerve stimulation"
16737|NCT02590939|P1|Participant Flow|Active Device|"60 minutes of active external trigeminal nerve stimulation with a CEFALY device~CEFALY Active: Active external trigeminal nerve stimulation"
16738|NCT02590939|O2|Outcome|Sham Device|"60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device~CEFALY Placebo: Placebo external trigeminal nerve stimulation"
16739|NCT02590939|O1|Outcome|Active Device|"60 minutes of active external trigeminal nerve stimulation with a CEFALY device~CEFALY Active: Active external trigeminal nerve stimulation"
16740|NCT02590939|O2|Outcome|Sham Device|"60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device~CEFALY Placebo: Placebo external trigeminal nerve stimulation"
16741|NCT02590939|O1|Outcome|Active Device|"60 minutes of active external trigeminal nerve stimulation with a CEFALY device~CEFALY Active: Active external trigeminal nerve stimulation"
16742|NCT02590939|O2|Outcome|Sham Device|"60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device~CEFALY Placebo: Placebo external trigeminal nerve stimulation"
16743|NCT02590939|O1|Outcome|Active Device|"60 minutes of active external trigeminal nerve stimulation with a CEFALY device~CEFALY Active: Active external trigeminal nerve stimulation"
16744|NCT02590939|O2|Outcome|Sham Device|"60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device~CEFALY Placebo: Placebo external trigeminal nerve stimulation"
16745|NCT02590939|O1|Outcome|Active Device|"60 minutes of active external trigeminal nerve stimulation with a CEFALY device~CEFALY Active: Active external trigeminal nerve stimulation"
16746|NCT02590939|O2|Outcome|Sham Device|"60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device~CEFALY Placebo: Placebo external trigeminal nerve stimulation"
16747|NCT02590939|O1|Outcome|Active Device|"60 minutes of active external trigeminal nerve stimulation with a CEFALY device~CEFALY Active: Active external trigeminal nerve stimulation"
16748|NCT02590939|O2|Outcome|Sham Device|"60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device~CEFALY Placebo: Placebo external trigeminal nerve stimulation"
16749|NCT02590939|O1|Outcome|Active Device|"60 minutes of active external trigeminal nerve stimulation with a CEFALY device~CEFALY Active: Active external trigeminal nerve stimulation"
16750|NCT02590939|O2|Outcome|Sham Device|"60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device~CEFALY Placebo: Placebo external trigeminal nerve stimulation"
16751|NCT02590939|O1|Outcome|Active Device|"60 minutes of active external trigeminal nerve stimulation with a CEFALY device~CEFALY Active: Active external trigeminal nerve stimulation"
16752|NCT02590939|O2|Outcome|Sham Device|"60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device~CEFALY Placebo: Placebo external trigeminal nerve stimulation"
16753|NCT02590939|O1|Outcome|Active Device|"60 minutes of active external trigeminal nerve stimulation with a CEFALY device~CEFALY Active: Active external trigeminal nerve stimulation"
16754|NCT02590939|E2|Reported Event|Sham Device|"60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device~CEFALY Placebo: Placebo external trigeminal nerve stimulation"
16755|NCT02590939|E1|Reported Event|Active Device|"60 minutes of active external trigeminal nerve stimulation with a CEFALY device~CEFALY Active: Active external trigeminal nerve stimulation"
16756|NCT02590588|B1|Baseline|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.~Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
16757|NCT02590588|P1|Participant Flow|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.~Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
16758|NCT02590588|O1|Outcome|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.~Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
16759|NCT02590588|O1|Outcome|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.~Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
16760|NCT02590588|O1|Outcome|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.~Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
16761|NCT02590588|O1|Outcome|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.~Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
16762|NCT02590588|O1|Outcome|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.~Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
16763|NCT02590588|E1|Reported Event|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.~Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
16764|NCT02590562|B1|Baseline|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16765|NCT02590562|P1|Participant Flow|Overall Population|Participants diagnosed with rheumatoid arthritis (RA) according to American College of Rheumatology (ACR) 1987 criteria who were using biological disease-modifying anti-rheumatic drugs (DMARDs) approved in China for RA treatment were observed at the single study visit (enrollment visit).
16766|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16767|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16768|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16828|NCT02590003|O2|Outcome|Single Agent Chemotherapy|"-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Nab-paclitaxel"
16769|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16770|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16771|NCT02590562|O2|Outcome|Biological Agent as Combination With csDMARDs|Participants were divided into two groups according to whether using biological agent (namely, biological agent concomitant with csDMARDs treatment group and biological agent without csDMARDs treatment group). This group included participants using biological agent with concomitant csDMARDs.
16772|NCT02590562|O1|Outcome|Biological Agent as Monotherapy|Participants were divided into two groups according to whether using biological agent (namely, biological agent concomitant with csDMARDs treatment group and biological agent without csDMARDs treatment group). This group included participants using biological agent without concomitant csDMARDs.
16773|NCT02590562|O4|Outcome|Duration of Biological Treatment >=12 Months|Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment >=12 months.
16774|NCT02590562|O3|Outcome|Duration of Biological Treatment >=6 to <12 Months|Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment >=6 to <12 months.
16775|NCT02590562|O2|Outcome|Duration of Biological Treatment >=3 to <6 Months|Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment >=3 to <6 months.
16776|NCT02590562|O1|Outcome|Duration of Biological Treatment <3 Months|Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment <3 months.
16777|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16778|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16779|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16780|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16781|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16782|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16783|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16784|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16785|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16786|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16787|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16788|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16789|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16790|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16791|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16792|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16793|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16794|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16795|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16796|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16797|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16798|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16799|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16800|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16801|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16802|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16803|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16804|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16805|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16806|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16807|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16808|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16809|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16810|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16811|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16812|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16813|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16814|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16815|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16816|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16817|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16818|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16819|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16820|NCT02590562|E1|Reported Event|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
16821|NCT02590003|B3|Baseline|Total|Total of all reporting groups
16822|NCT02590003|B2|Baseline|Single Agent Chemotherapy|"-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Nab-paclitaxel"
16823|NCT02590003|B1|Baseline|Platinum-based Doublet Chemotherapy|"Carboplatin AUC 5 30 minute infusion IV on day 1~Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Carboplatin~Nab-paclitaxel"
16824|NCT02590003|P2|Participant Flow|Single Agent Chemotherapy|"-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Nab-paclitaxel"
16825|NCT02590003|P1|Participant Flow|Platinum-based Doublet Chemotherapy|"Carboplatin AUC 5 30 minute infusion IV on day 1~Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Carboplatin~Nab-paclitaxel"
16826|NCT02590003|O2|Outcome|Single Agent Chemotherapy|"-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Nab-paclitaxel"
16827|NCT02590003|O1|Outcome|Platinum-based Doublet Chemotherapy|"Carboplatin AUC 5 30 minute infusion IV on day 1~Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Carboplatin~Nab-paclitaxel"
17747|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
16829|NCT02590003|O1|Outcome|Platinum-based Doublet Chemotherapy|"Carboplatin AUC 5 30 minute infusion IV on day 1~Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Carboplatin~Nab-paclitaxel"
16830|NCT02590003|O2|Outcome|Single Agent Chemotherapy|"-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Nab-paclitaxel"
16831|NCT02590003|O1|Outcome|Platinum-based Doublet Chemotherapy|"Carboplatin AUC 5 30 minute infusion IV on day 1~Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Carboplatin~Nab-paclitaxel"
16832|NCT02590003|O2|Outcome|Single Agent Chemotherapy|"-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Nab-paclitaxel"
16833|NCT02590003|O1|Outcome|Platinum-based Doublet Chemotherapy|"Carboplatin AUC 5 30 minute infusion IV on day 1~Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Carboplatin~Nab-paclitaxel"
16834|NCT02590003|O2|Outcome|Single Agent Chemotherapy|"-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Nab-paclitaxel"
16835|NCT02590003|O1|Outcome|Platinum-based Doublet Chemotherapy|"Carboplatin AUC 5 30 minute infusion IV on day 1~Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Carboplatin~Nab-paclitaxel"
16836|NCT02590003|O2|Outcome|Single Agent Chemotherapy|"-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Nab-paclitaxel"
16837|NCT02590003|O1|Outcome|Platinum-based Doublet Chemotherapy|"Carboplatin AUC 5 30 minute infusion IV on day 1~Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Carboplatin~Nab-paclitaxel"
16838|NCT02590003|O2|Outcome|Single Agent Chemotherapy|"-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Nab-paclitaxel"
16839|NCT02590003|O1|Outcome|Platinum-based Doublet Chemotherapy|"Carboplatin AUC 5 30 minute infusion IV on day 1~Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Carboplatin~Nab-paclitaxel"
16840|NCT02590003|O2|Outcome|Single Agent Chemotherapy|"-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Nab-paclitaxel"
16841|NCT02590003|O1|Outcome|Platinum-based Doublet Chemotherapy|"Carboplatin AUC 5 30 minute infusion IV on day 1~Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Carboplatin~Nab-paclitaxel"
16842|NCT02590003|E2|Reported Event|Platinum-based Doublet Chemotherapy|"Carboplatin AUC 5 30 minute infusion IV on day 1~Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Carboplatin~Nab-paclitaxel"
16843|NCT02590003|E1|Reported Event|Single Agent Chemotherapy|"-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Nab-paclitaxel"
16844|NCT02588976|B1|Baseline|All Patients|
16845|NCT02588976|P1|Participant Flow|ACT Measurements|"ACT measurements by SONOCLOT Analyzer during cardiac surgery~Sonoclot Analyzer: Blood coagulation test during cardiac surgery: Measurement of activated clotting time during cardiac surgery by Sonoclot Analyzer"
16846|NCT02588976|O1|Outcome|ACT Measurements|"ACT measurements by SONOCLOT Analyzer during cardiac surgery~Sonoclot Analyzer: Blood coagulation test during cardiac surgery: Measurement of activated clotting time during cardiac surgery by Sonoclot Analyzer"
16847|NCT02588976|O1|Outcome|All Patients|
16848|NCT02588976|E1|Reported Event|All Patients|
16849|NCT02588872|B3|Baseline|Total|Total of all reporting groups
16850|NCT02588872|B2|Baseline|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.~Platelet-rich Plasma (PRP)"
16851|NCT02588872|B1|Baseline|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.~Hyaluronic Acid"
16852|NCT02588872|P2|Participant Flow|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.~Platelet-rich Plasma (PRP)"
16853|NCT02588872|P1|Participant Flow|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.~Hyaluronic Acid"
16854|NCT02588872|O2|Outcome|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.~Platelet-rich Plasma (PRP)"
16855|NCT02588872|O1|Outcome|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.~Hyaluronic Acid"
16856|NCT02588872|O2|Outcome|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.~Platelet-rich Plasma (PRP)"
16857|NCT02588872|O1|Outcome|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.~Hyaluronic Acid"
16858|NCT02588872|O2|Outcome|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.~Platelet-rich Plasma (PRP)"
16859|NCT02588872|O1|Outcome|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.~Hyaluronic Acid"
16929|NCT02586805|E2|Reported Event|Lanadelumab (DX-2930) 150 mg Every 4 Weeks|Participants received 150 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
16860|NCT02588872|O2|Outcome|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.~Platelet-rich Plasma (PRP)"
16861|NCT02588872|O1|Outcome|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.~Hyaluronic Acid"
16862|NCT02588872|O2|Outcome|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.~Platelet-rich Plasma (PRP)"
16863|NCT02588872|O1|Outcome|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.~Hyaluronic Acid"
16864|NCT02588872|E2|Reported Event|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.~Platelet-rich Plasma (PRP)"
16865|NCT02588872|E1|Reported Event|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.~Hyaluronic Acid"
16866|NCT02588599|B1|Baseline|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
16867|NCT02588599|P1|Participant Flow|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
16868|NCT02588599|O1|Outcome|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
16869|NCT02588599|O1|Outcome|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
16870|NCT02588599|E1|Reported Event|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
16871|NCT02587819|B1|Baseline|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
16872|NCT02587819|P1|Participant Flow|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
16873|NCT02587819|O1|Outcome|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
16874|NCT02587819|O1|Outcome|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
16875|NCT02587819|O1|Outcome|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
16876|NCT02587819|O1|Outcome|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days post baseline to all subjects. All (21 of 21) subjects returned for safety and tolerability assessments at days 3, 8, 15 and 29 post-Baseline. 20 of 21 patients returned for final safety assessments at 57 days post-Baseline.
16877|NCT02587819|E1|Reported Event|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
16878|NCT02587234|B3|Baseline|Total|Total of all reporting groups
16879|NCT02587234|B2|Baseline|Sham PNS|"2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training~peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
16880|NCT02587234|B1|Baseline|Active PNS|"2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training~peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
16881|NCT02587234|P2|Participant Flow|Sham PNS|"2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training~peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
16882|NCT02587234|P1|Participant Flow|Active|"2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training~peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
16883|NCT02587234|O2|Outcome|Sham PNS|"2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training~peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
16884|NCT02587234|O1|Outcome|Active PNS|"2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training~peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
16885|NCT02587234|O2|Outcome|Sham PNS|"2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training~peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
16886|NCT02587234|O1|Outcome|Active PNS|"2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training~peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
16887|NCT02587234|O2|Outcome|Sham PNS|"2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training~peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
16888|NCT02587234|O1|Outcome|Active PNS|"2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training~peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
16889|NCT02587234|E2|Reported Event|Sham PNS|"2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training~peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
16890|NCT02587234|E1|Reported Event|Active PNS|"2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training~peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
16891|NCT02587117|B3|Baseline|Total|Total of all reporting groups
16892|NCT02587117|B2|Baseline|Prednisolone Group|Prednisolone- 40 mg capsule by mouth single dose per day for 2 months
16893|NCT02587117|B1|Baseline|Lycopene Group|Lycopene- 4 mg capsule by mouth single dose per day for 2 months
16894|NCT02587117|P2|Participant Flow|Prednisolone Group|Prednisolone- 40 mg capsule by mouth single dose per day for 2 months
16895|NCT02587117|P1|Participant Flow|Lycopene Group|Lycopene- 4 mg capsule by mouth single dose per day for 2 months
16896|NCT02587117|O2|Outcome|Prednisolone Group|"Prednisolone- 40 mg capsule by mouth single dose per day for 2 months~Prednisolone: Each capsule contain 20 mg prednisolone. Each patient was received two capsules of prednisolone (total dose was 40 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy."
16897|NCT02587117|O1|Outcome|Lycopene Group|"Lycopene- 4 mg capsule by mouth single dose per day for 2 months~lycopene: Each capsule contain 2 mg lycopene. Each patient was received two capsules of lycopene (total dose was 4 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy."
16898|NCT02587117|O2|Outcome|Prednisolone Group|"Prednisolone- 40 mg capsule by mouth single dose per day for 2 months~Prednisolone: Each capsule contain 20 mg prednisolone. Each patient was received two capsules of prednisolone (total dose was 40 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy."
16899|NCT02587117|O1|Outcome|Lycopene Group|"Lycopene- 4 mg capsule by mouth single dose per day for 2 months~lycopene: Each capsule contain 2 mg lycopene. Each patient was received two capsules of lycopene (total dose was 4 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy."
16900|NCT02587117|E2|Reported Event|Prednisolone Group|Prednisolone- 40 mg capsule by mouth single dose per day for 2 months
16901|NCT02587117|E1|Reported Event|Lycopene Group|Lycopene- 4 mg capsule by mouth single dose per day for 2 months
16902|NCT02586805|B5|Baseline|Total|Total of all reporting groups
16903|NCT02586805|B4|Baseline|Lanadelumab (DX-2930) 300 mg Every 2 Weeks|Participants received 300 mg dose of DX-2930 SC q2wks for 26 weeks.
16904|NCT02586805|B3|Baseline|Lanadelumab (DX-2930) 300 mg Every 4 Weeks|Participants received 300 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
16905|NCT02586805|B2|Baseline|Lanadelumab (DX-2930) 150 mg Every 4 Weeks|Participants received 150 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
16906|NCT02586805|B1|Baseline|Placebo|Participants received placebo matched to DX-2930 SC q2wks for 26 weeks.
16907|NCT02586805|P4|Participant Flow|Lanadelumab (DX-2930) 300 mg Every 2 Weeks|Participants received 300 mg dose of DX-2930 SC q2wks for 26 weeks.
16908|NCT02586805|P3|Participant Flow|Lanadelumab (DX-2930) 300 mg Every 4 Weeks|Participants received 300 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
16909|NCT02586805|P2|Participant Flow|Lanadelumab (DX-2930) 150 mg Every 4 Weeks|Participants received 150 milligram (mg) dose of DX-2930 SC once in every 4 weeks (q4wks) and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
16910|NCT02586805|P1|Participant Flow|Placebo|Participants received placebo matched to DX-2930 subcutaneously (SC) once in every 2 weeks (q2wks) for 26 weeks.
16911|NCT02586805|O4|Outcome|Lanadelumab (DX-2930) 300 mg Every 2 Weeks|Participants received 300 mg dose of DX-2930 SC q2wks for 26 weeks.
16912|NCT02586805|O3|Outcome|Lanadelumab (DX-2930) 300 mg Every 4 Weeks|Participants received 300 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
16913|NCT02586805|O2|Outcome|Lanadelumab (DX-2930) 150 mg Every 4 Weeks|Participants received 150 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
16914|NCT02586805|O1|Outcome|Placebo|Participants received placebo matched to DX-2930 SC q2wks for 26 weeks.
16915|NCT02586805|O4|Outcome|Lanadelumab (DX-2930) 300 mg Every 2 Weeks|Participants received 300 mg dose of DX-2930 SC q2wks for 26 weeks.
16916|NCT02586805|O3|Outcome|Lanadelumab (DX-2930) 300 mg Every 4 Weeks|Participants received 300 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
16917|NCT02586805|O2|Outcome|Lanadelumab (DX-2930) 150 mg Every 4 Weeks|Participants received 150 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
16918|NCT02586805|O1|Outcome|Placebo|Participants received placebo matched to DX-2930 SC q2wks for 26 weeks.
16919|NCT02586805|O4|Outcome|Lanadelumab (DX-2930) 300 mg Every 2 Weeks|Participants received 300 mg dose of DX-2930 SC q2wks for 26 weeks.
16920|NCT02586805|O3|Outcome|Lanadelumab (DX-2930) 300 mg Every 4 Weeks|Participants received 300 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
16921|NCT02586805|O2|Outcome|Lanadelumab (DX-2930) 150 mg Every 4 Weeks|Participants received 150 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
16922|NCT02586805|O1|Outcome|Placebo|Participants received placebo matched to DX-2930 SC q2wks for 26 weeks.
16923|NCT02586805|O4|Outcome|Lanadelumab (DX-2930) 300 mg Every 2 Weeks|Participants received 300 mg dose of DX-2930 SC q2wks for 26 weeks.
16924|NCT02586805|O3|Outcome|Lanadelumab (DX-2930) 300 mg Every 4 Weeks|Participants received 300 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
16925|NCT02586805|O2|Outcome|Lanadelumab (DX-2930) 150 mg Every 4 Weeks|Participants received 150 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
16926|NCT02586805|O1|Outcome|Placebo|Participants received placebo matched to DX-2930 SC q2wks for 26 weeks.
16927|NCT02586805|E4|Reported Event|Lanadelumab (DX-2930) 300 mg Every 2 Weeks|Participants received 300 mg dose of DX-2930 SC q2wks for 26 weeks.
16928|NCT02586805|E3|Reported Event|Lanadelumab (DX-2930) 300 mg Every 4 Weeks|Participants received 300 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
16930|NCT02586805|E1|Reported Event|Placebo|Participants received placebo matched to DX-2930 SC q2wks for 26 weeks.
16931|NCT02586506|B1|Baseline|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
16932|NCT02586506|P1|Participant Flow|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
16933|NCT02586506|O1|Outcome|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
16934|NCT02586506|O1|Outcome|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
16935|NCT02586506|O1|Outcome|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
16936|NCT02586506|E1|Reported Event|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
16937|NCT02586493|B1|Baseline|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
16938|NCT02586493|P1|Participant Flow|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
16939|NCT02586493|O1|Outcome|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
16940|NCT02586493|O1|Outcome|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
16941|NCT02586493|O1|Outcome|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
16942|NCT02586493|E1|Reported Event|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
16943|NCT02585999|B1|Baseline|Xulane|"Participants exposed to contraceptive patch, Xulane.~Xulane Contraceptive Patch (generic version of Ortho Evra®*): Extended use (12 Weeks) of Contraceptive Patch"
16944|NCT02585999|P1|Participant Flow|Xulane|"Participants exposed to contraceptive patch, Xulane.~Xulane Contraceptive Patch (generic version of Ortho Evra®*): Extended use (12 Weeks) of Contraceptive Patch"
16945|NCT02585999|O1|Outcome|Xulane|"All participants using the Xulane contraceptive patch for 12 continuous weeks~Xulane Contraceptive Patch: Extended use (12 weeks) of contraceptive patch"
16946|NCT02585999|O1|Outcome|Xulane|Participants exposed to Xulane Contraceptive Patch for 12 weeks of continuous use
16947|NCT02585999|E1|Reported Event|Xulane|All participants using the Xulane contraceptive patch for 12 continuous weeks
16948|NCT02585895|B3|Baseline|Total|Total of all reporting groups
17256|NCT02582632|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir|ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
16949|NCT02585895|B2|Baseline|Evolocumab|Participants received 140 mg evolocumab every 2 weeks (Q2W) administered by subcutaneous injection for 6 weeks during the primary period of the study. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
16950|NCT02585895|B1|Baseline|Apheresis|Participants continued apheresis at the same schedule, every week (QW) or every two weeks (Q2W), as prior to study entry, for the first 6 weeks. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
16951|NCT02585895|P2|Participant Flow|Evolocumab|Participants received 140 mg evolocumab every 2 weeks (Q2W) administered by subcutaneous injection for 6 weeks during the primary period of the study. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
16952|NCT02585895|P1|Participant Flow|Apheresis|Participants continued apheresis at the same schedule, every week (QW) or every two weeks (Q2W), as prior to study entry, for the first 6 weeks. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
16953|NCT02585895|O2|Outcome|Evolocumab|Participants received 140 mg evolocumab every 2 weeks (Q2W) administered by subcutaneous injection for 6 weeks during the primary period of the study. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
16954|NCT02585895|O1|Outcome|Apheresis|Participants continued apheresis at the same schedule, every week (QW) or every two weeks (Q2W), as prior to study entry, for the first 6 weeks. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
16955|NCT02585895|O2|Outcome|Evolocumab|Participants received 140 mg evolocumab every 2 weeks (Q2W) administered by subcutaneous injection for 6 weeks during the primary period of the study. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
16956|NCT02585895|O1|Outcome|Apheresis|Participants continued apheresis at the same schedule, every week (QW) or every two weeks (Q2W), as prior to study entry, for the first 6 weeks. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
16957|NCT02585895|O2|Outcome|Evolocumab|Participants received 140 mg evolocumab every 2 weeks (Q2W) administered by subcutaneous injection for 6 weeks during the primary period of the study. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
16958|NCT02585895|O1|Outcome|Apheresis|Participants continued apheresis at the same schedule, every week (QW) or every two weeks (Q2W), as prior to study entry, for the first 6 weeks. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
16959|NCT02585895|O2|Outcome|Evolocumab|Participants received 140 mg evolocumab every 2 weeks (Q2W) administered by subcutaneous injection for 6 weeks during the primary period of the study. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
16960|NCT02585895|O1|Outcome|Apheresis|Participants continued apheresis at the same schedule, every week (QW) or every two weeks (Q2W), as prior to study entry, for the first 6 weeks. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
16961|NCT02585895|E5|Reported Event|Post-primary Period: Evolocumab/Evolocumab|Participants received 140 mg evolocumab Q2W from week 6 to week 24.
16962|NCT02585895|E4|Reported Event|Post-primary Period: Apheresis/Evolocumab|Starting at week 6 participants received 140 mg evolocumab Q2W up to week 24.
16963|NCT02585895|E3|Reported Event|Primary Period: Evolocumab|Participants received 140 mg evolocumab every 2 weeks (Q2W) administered by subcutaneous injection for 6 weeks during the primary period of the study.
16964|NCT02585895|E2|Reported Event|Primary Period: Apheresis Q2W|Participants received apheresis every 2 weeks (Q2W) for 6 weeks during the primary period of the study.
16965|NCT02585895|E1|Reported Event|Primary Period: Apheresis QW|Participants received apheresis every week (QW) for 6 weeks during the primary period of the study.
16966|NCT02585778|B5|Baseline|Total|Total of all reporting groups
16967|NCT02585778|B4|Baseline|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
16968|NCT02585778|B3|Baseline|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
16969|NCT02585778|B2|Baseline|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
16970|NCT02585778|B1|Baseline|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
16971|NCT02585778|P2|Participant Flow|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
16972|NCT02585778|P1|Participant Flow|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg subcutaneous (SC) injection every 2 weeks (Q2W) added to stable, maximally tolerated dose of statin therapy with or without other lipid-modifying therapy (LMT), insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
16973|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
16974|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
16975|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
16976|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
16977|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
16978|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
16979|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
16980|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
16981|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
16982|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
16983|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
16984|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
16985|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
16986|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
16987|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
16988|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
16989|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
16990|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
16991|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
16992|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
16993|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
16994|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
16995|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
16996|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
16997|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17748|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
16998|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
16999|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17000|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17001|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17002|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17003|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17004|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17005|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17006|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17007|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17008|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17009|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17010|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17011|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17012|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17013|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17014|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17015|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17016|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17017|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17018|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17019|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17020|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17021|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17022|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17023|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17024|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17025|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17026|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17027|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17028|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17029|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17030|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17031|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17032|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17033|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17034|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17035|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17036|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17037|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17038|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17039|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17040|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17041|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17042|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17043|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17749|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
17044|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17045|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17046|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17047|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17048|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17049|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17050|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17051|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17052|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17053|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17054|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17055|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17056|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17057|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17058|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17059|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17060|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17061|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17062|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17063|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17064|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17065|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17066|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17067|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17068|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17069|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17070|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17071|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17072|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17073|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17074|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17075|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17076|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17077|NCT02585778|O2|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17078|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17079|NCT02585778|O4|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17080|NCT02585778|O3|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17081|NCT02585778|O2|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17082|NCT02585778|O1|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17083|NCT02585778|E2|Reported Event|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
17084|NCT02585778|E1|Reported Event|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
17085|NCT02585245|B1|Baseline|All Participants|All patients received both the NRS 2002 and the ThedaCare Nutrition Risk Screen. Patients identified at HIgh, medium or Low Risk in Hospitalized patients. Determining accuracy of identifiying patients affected by malnutrition.
17086|NCT02585245|P1|Participant Flow|All Participants|All patients received both the NRS 2002 and the ThedaCare Nutrition Risk Screen. Patients identified at HIgh, medium or Low Risk in Hospitalized patients. Determining accuracy of identifiying patients affected by malnutrition.
17087|NCT02585245|O2|Outcome|ThedaCare RD/RN Nutrition Risk Screen|Patients identified at HIgh, medium or Low Risk in Hospitalized patients. Determining accuracy of identifiying patients affected by malnutrition.
17088|NCT02585245|O1|Outcome|NRS2002 Nutrition Risk Screen|Patients identified at HIgh, medium or Low Risk in Hospitalized patients. Determining accuracy of identifiying patients affected by malnutrition.
17089|NCT02585245|E1|Reported Event|All Participants|All patients received both the NRS 2002 and the ThedaCare Nutrition Risk Screen. Patients identified at HIgh, medium or Low Risk in Hospitalized patients. Determining accuracy of identifiying patients affected by malnutrition.
17189|NCT02584504|O1|Outcome|Alirocumab 150 mg Q4W|Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17750|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
17090|NCT02584790|B1|Baseline|Post Radiotherapy 8 Weeks NPC Patient|"All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system~Laryngoscope with NBI system: All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system"
17091|NCT02584790|P1|Participant Flow|Post Radiotherapy 8 Weeks NPC Patient|"All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system~Laryngoscope with NBI system: All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system"
17092|NCT02584790|O1|Outcome|Post Radiotherapy 8 Weeks NPC Patient|"All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system~Laryngoscope with NBI system: All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system"
17093|NCT02584790|O1|Outcome|Post Radiotherapy 8 Weeks NPC Patient|"All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system~Laryngoscope with NBI system: All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system"
17094|NCT02584790|O1|Outcome|Post Radiotherapy 8 Weeks NPC Patient|"All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system~Laryngoscope with NBI system: All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system"
17095|NCT02584790|E1|Reported Event|Post Radiotherapy 8 Weeks NPC Patient|"All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system~Laryngoscope with NBI system: All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system"
17096|NCT02584686|B3|Baseline|Total|Total of all reporting groups
17097|NCT02584686|B2|Baseline|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
17098|NCT02584686|B1|Baseline|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
17099|NCT02584686|P2|Participant Flow|Control Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
17100|NCT02584686|P1|Participant Flow|Study Group|"The treatment group, 12 patients will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
17101|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
17190|NCT02584504|O3|Outcome|Placebo Q2W|Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
26763|NCT02480582|O1|Outcome|Almonds|"Whole, raw almonds~Almonds"
17102|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
17103|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
17104|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
17105|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
17106|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
17107|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
17108|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
17109|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
17110|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
17111|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
17112|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
17113|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
17114|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
17115|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
17116|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
17117|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
17191|NCT02584504|O2|Outcome|Alirocumab 150 mg Q2W|Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17751|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
17118|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
17119|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
17120|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
17121|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
17122|NCT02584686|O1|Outcome|(BTX) A|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
17123|NCT02584686|E2|Reported Event|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
17124|NCT02584686|E1|Reported Event|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
17125|NCT02584673|B3|Baseline|Total|Total of all reporting groups
17126|NCT02584673|B2|Baseline|Control|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
17127|NCT02584673|B1|Baseline|CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
17128|NCT02584673|P2|Participant Flow|Control|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
17129|NCT02584673|P1|Participant Flow|CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
17130|NCT02584673|O2|Outcome|Control|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
17131|NCT02584673|O1|Outcome|CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
17132|NCT02584673|O2|Outcome|Control|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
17133|NCT02584673|O1|Outcome|CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
17134|NCT02584673|O2|Outcome|Control|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
17135|NCT02584673|O1|Outcome|CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
17136|NCT02584673|O2|Outcome|Control|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
17192|NCT02584504|O1|Outcome|Alirocumab 150 mg Q4W|Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17137|NCT02584673|O1|Outcome|CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
17138|NCT02584673|E2|Reported Event|Control|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
17139|NCT02584673|E1|Reported Event|CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
17140|NCT02584660|B3|Baseline|Total|Total of all reporting groups
17141|NCT02584660|B2|Baseline|Standard-of-care|Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.
17142|NCT02584660|B1|Baseline|Rivaroxaban|Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.
17143|NCT02584660|P2|Participant Flow|Standard-of-care|Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.
17144|NCT02584660|P1|Participant Flow|Rivaroxaban|Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.
17145|NCT02584660|O2|Outcome|Standard-of-care|Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.
17146|NCT02584660|O1|Outcome|Rivaroxaban|Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.
17147|NCT02584660|O2|Outcome|Standard-of-care|Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.
17148|NCT02584660|O1|Outcome|Rivaroxaban|Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.
17149|NCT02584660|O2|Outcome|Standard-of-care|Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.
17150|NCT02584660|O1|Outcome|Rivaroxaban|Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.
17151|NCT02584660|O2|Outcome|Standard-of-care|Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.
17152|NCT02584660|O1|Outcome|Rivaroxaban|Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.
17153|NCT02584660|O2|Outcome|Standard-of-care|Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.
17154|NCT02584660|O1|Outcome|Rivaroxaban|Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.
17155|NCT02584660|O2|Outcome|Standard-of-care|Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.
17156|NCT02584660|O1|Outcome|Rivaroxaban|Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.
17157|NCT02584660|E2|Reported Event|Standard-of-care|Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.
17158|NCT02584660|E1|Reported Event|Rivaroxaban|Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.
17159|NCT02584504|B4|Baseline|Total|Total of all reporting groups
17160|NCT02584504|B3|Baseline|Placebo Q2W|In DBTP, participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks. Participants who completed DBTP were entered in OLTP and received alirocumab 150 mg Q4W. Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
17161|NCT02584504|B2|Baseline|Alirocumab 150 mg Q2W|In DBTP, participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks. Participants who completed DBTP were entered in OLTP and received alirocumab 150 mg Q4W. Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
17162|NCT02584504|B1|Baseline|Alirocumab 150 mg Q4W|In DBTP, participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks. Participants who completed DBTP were entered in OLTP and received alirocumab 150 mg Q4W. Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
17163|NCT02584504|P3|Participant Flow|Placebo Q2W|In DBTP, participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks. Participants who completed DBTP were entered in OLTP and received alirocumab 150 mg Q4W. Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
17752|NCT02576639|O5|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
17164|NCT02584504|P2|Participant Flow|Alirocumab 150 mg Q2W|In DBTP, participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks. Participants who completed DBTP were entered in OLTP and received alirocumab 150 mg Q4W. Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
17165|NCT02584504|P1|Participant Flow|Alirocumab 150 mg Q4W|In double-blind treatment period (DBTP), participants received Alirocumab 150 mg subcutaneous (SC) injection every 4 weeks (Q4W) alternating with placebo (for alirocumab) Q4W added to lowest-strength statin therapy (atorvastatin 5 mg daily), stable non-statin Lipid-Modifying Therapy (LMT) or diet therapy alone for 12 weeks. Participants who completed DBTP, entered in open-label treatment period (OLTP) and received alirocumab 150 mg Q4W. Alirocumab dose up-titrated to 150 mg every 2 weeks (Q2W) at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
17166|NCT02584504|O3|Outcome|Placebo Q2W|Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17167|NCT02584504|O2|Outcome|Alirocumab 150 mg Q2W|Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17168|NCT02584504|O1|Outcome|Alirocumab 150 mg Q4W|Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17169|NCT02584504|O3|Outcome|Placebo Q2W|Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17170|NCT02584504|O2|Outcome|Alirocumab 150 mg Q2W|Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17171|NCT02584504|O1|Outcome|Alirocumab 150 mg Q4W|Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17172|NCT02584504|O3|Outcome|Placebo Q2W|Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17173|NCT02584504|O2|Outcome|Alirocumab 150 mg Q2W|Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17174|NCT02584504|O1|Outcome|Alirocumab 150 mg Q4W|Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17175|NCT02584504|O3|Outcome|Placebo Q2W|Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17176|NCT02584504|O2|Outcome|Alirocumab 150 mg Q2W|Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17177|NCT02584504|O1|Outcome|Alirocumab 150 mg Q4W|Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17178|NCT02584504|O3|Outcome|Placebo Q2W|Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17179|NCT02584504|O2|Outcome|Alirocumab 150 mg Q2W|Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17180|NCT02584504|O1|Outcome|Alirocumab 150 mg Q4W|Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17181|NCT02584504|O3|Outcome|Placebo Q2W|Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17182|NCT02584504|O2|Outcome|Alirocumab 150 mg Q2W|Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17183|NCT02584504|O1|Outcome|Alirocumab 150 mg Q4W|Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17184|NCT02584504|O3|Outcome|Placebo Q2W|Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17185|NCT02584504|O2|Outcome|Alirocumab 150 mg Q2W|Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17186|NCT02584504|O1|Outcome|Alirocumab 150 mg Q4W|Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17187|NCT02584504|O3|Outcome|Placebo Q2W|Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17188|NCT02584504|O2|Outcome|Alirocumab 150 mg Q2W|Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17753|NCT02576639|O4|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
17193|NCT02584504|O3|Outcome|Placebo Q2W|Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17194|NCT02584504|O2|Outcome|Alirocumab 150 mg Q2W|Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17195|NCT02584504|O1|Outcome|Alirocumab 150 mg Q4W|Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17196|NCT02584504|O3|Outcome|Placebo Q2W|Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17197|NCT02584504|O2|Outcome|Alirocumab 150 mg Q2W|Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17198|NCT02584504|O1|Outcome|Alirocumab 150 mg Q4W|Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17199|NCT02584504|O3|Outcome|Placebo Q2W|Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17200|NCT02584504|O2|Outcome|Alirocumab 150 mg Q2W|Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17201|NCT02584504|O1|Outcome|Alirocumab 150 mg Q4W|Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17202|NCT02584504|O3|Outcome|Placebo Q2W|Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17203|NCT02584504|O2|Outcome|Alirocumab 150 mg Q2W|Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17204|NCT02584504|O1|Outcome|Alirocumab 150 mg Q4W|Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17205|NCT02584504|O3|Outcome|Placebo Q2W|Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17206|NCT02584504|O2|Outcome|Alirocumab 150 mg Q2W|Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17207|NCT02584504|O1|Outcome|Alirocumab 150 mg Q4W|Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17208|NCT02584504|O3|Outcome|Placebo Q2W|Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17209|NCT02584504|O2|Outcome|Alirocumab 150 mg Q2W|Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17210|NCT02584504|O1|Outcome|Alirocumab 150 mg Q4W|Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
17211|NCT02584504|E4|Reported Event|Alirocumab Exposed Period :Alirocumab 150 mg Q4W/Up Q2W|All participants who actually received at least one dose or partial dose of alirocumab (double-blind or open-label). Alirocumab exposed period was defined as the time from the first dose of alirocumab injection. After entered into OLTP, all participants received alirocumab 150 mg Q4W. Alirocumab dose up-titrated from 150 mg Q4W to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 20 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
17212|NCT02584504|E3|Reported Event|Double-blind Treatment Period: Placebo Q2W|Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks.
17213|NCT02584504|E2|Reported Event|Double-blind Treatment Period: Alirocumab 150 mg Q2W|Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks.
17214|NCT02584504|E1|Reported Event|Double-blind Treatment Period: Alirocumab 150 mg Q4W|Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily) stable non-statin LMT or diet therapy alone for 12 weeks.
17215|NCT02583425|B1|Baseline|DFN-11|DFN-11 Injection upon occurrence of migraine
17216|NCT02583425|P1|Participant Flow|DFN-11|DFN-11 Injection upon occurrence of migraine
17217|NCT02583425|O1|Outcome|DFN-11|"DFN-11 Injection upon occurrence of migraine~DFN-11 Injection"
17218|NCT02583425|O1|Outcome|DFN-11|"DFN-11 Injection upon occurrence of migraine headache~DFN-11 Injection"
17219|NCT02583425|E1|Reported Event|DFN-11|DFN-11 Injection upon occurrence of migraine
17220|NCT02582983|B1|Baseline|Enfuvirtide|Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
17221|NCT02582983|P1|Participant Flow|Enfuvirtide|Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
17222|NCT02582983|O1|Outcome|Enfuvirtide|Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
17223|NCT02582983|O1|Outcome|Enfuvirtide|Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
17224|NCT02582983|E1|Reported Event|Enfuvirtide|Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
17225|NCT02582970|B1|Baseline|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
17226|NCT02582970|P1|Participant Flow|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks (q2w) in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
17227|NCT02582970|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
17228|NCT02582970|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
17229|NCT02582970|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
17230|NCT02582970|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
17231|NCT02582970|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
17232|NCT02582970|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
17233|NCT02582970|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
17234|NCT02582970|E1|Reported Event|Bevacizumab + Chemotherapy|Participants received IV bevacizumab at a dose of 5 mg/kg q2w in combination with standard of care chemotherapy regimen until disease progression or until termination of the study.
17235|NCT02582684|B1|Baseline|Arm 1: DTG 50 MG + 3TC 300 mg|"Dolutegravir: Participants were prescribed 50 mg of DTG orally daily~Lamivudine: Participants were prescribed 300 mg of 3TC orally daily."
17236|NCT02582684|P1|Participant Flow|Arm 1: DTG 50 MG + 3TC 300 mg|"Dolutegravir: Participants were prescribed 50 mg of DTG orally daily~Lamivudine: Participants were prescribed 300 mg of 3TC orally daily."
17237|NCT02582684|O1|Outcome|Arm 1: DTG 50 MG + 3TC 300 mg|"Dolutegravir: Participants were prescribed 50 mg of DTG orally daily~Lamivudine: Participants were prescribed 300 mg of 3TC orally daily."
17238|NCT02582684|O1|Outcome|Arm 1: DTG 50 MG + 3TC 300 mg|"Dolutegravir: Participants were prescribed 50 mg of DTG orally daily~Lamivudine: Participants were prescribed 300 mg of 3TC orally daily."
17239|NCT02582684|O1|Outcome|Arm 1: DTG 50 MG + 3TC 300 mg|"Dolutegravir: Participants were prescribed 50 mg of DTG orally daily~Lamivudine: Participants were prescribed 300 mg of 3TC orally daily."
17240|NCT02582684|O1|Outcome|Arm 1: DTG 50 MG + 3TC 300 mg|"Dolutegravir: Participants were prescribed 50 mg of DTG orally daily~Lamivudine: Participants were prescribed 300 mg of 3TC orally daily."
17241|NCT02582684|O1|Outcome|Arm 1: DTG 50 MG + 3TC 300 mg|"Dolutegravir: Participants were prescribed 50 mg of DTG orally daily~Lamivudine: Participants were prescribed 300 mg of 3TC orally daily."
17242|NCT02582684|O1|Outcome|Arm 1: DTG 50 MG + 3TC 300 mg|"Dolutegravir: Participants were prescribed 50 mg of DTG orally daily~Lamivudine: Participants were prescribed 300 mg of 3TC orally daily."
17243|NCT02582684|O1|Outcome|Arm 1: DTG 50 MG + 3TC 300 mg|"Dolutegravir: Participants were prescribed 50 mg of DTG orally daily~Lamivudine: Participants were prescribed 300 mg of 3TC orally daily."
17244|NCT02582684|O1|Outcome|Arm 1: DTG 50 MG + 3TC 300 mg|"Dolutegravir: Participants were prescribed 50 mg of DTG orally daily~Lamivudine: Participants were prescribed 300 mg of 3TC orally daily."
17245|NCT02582684|O1|Outcome|Arm 1: DTG 50 MG + 3TC 300 mg|"Dolutegravir: Participants were prescribed 50 mg of DTG orally daily~Lamivudine: Participants were prescribed 300 mg of 3TC orally daily."
17246|NCT02582684|O1|Outcome|Arm 1: DTG 50 MG + 3TC 300 mg|"Dolutegravir: Participants were prescribed 50 mg of DTG orally daily~Lamivudine: Participants were prescribed 300 mg of 3TC orally daily."
17247|NCT02582684|O1|Outcome|Arm 1: DTG 50 MG + 3TC 300 mg|"Dolutegravir: Participants were prescribed 50 mg of DTG orally daily~Lamivudine: Participants were prescribed 300 mg of 3TC orally daily."
17248|NCT02582684|O1|Outcome|Arm 1: DTG 50 MG + 3TC 300 mg|"Dolutegravir: Participants were prescribed 50 mg of DTG orally daily~Lamivudine: Participants were prescribed 300 mg of 3TC orally daily."
17249|NCT02582684|O1|Outcome|Arm 1: DTG 50 MG + 3TC 300 mg|"Dolutegravir: Participants were prescribed 50 mg of DTG orally daily~Lamivudine: Participants were prescribed 300 mg of 3TC orally daily."
17250|NCT02582684|O1|Outcome|Arm 1: DTG 50 MG + 3TC 300 mg|"Dolutegravir: Participants were prescribed 50 mg of DTG orally daily~Lamivudine: Participants were prescribed 300 mg of 3TC orally daily."
17251|NCT02582684|O1|Outcome|Arm 1: DTG 50 MG + 3TC 300 mg|"Dolutegravir: Participants were prescribed 50 mg of DTG orally daily~Lamivudine: Participants were prescribed 300 mg of 3TC orally daily."
17252|NCT02582684|O1|Outcome|Arm 1: DTG 50 MG + 3TC 300 mg|"Dolutegravir: Participants were prescribed 50 mg of DTG orally daily~Lamivudine: Participants were prescribed 300 mg of 3TC orally daily."
17253|NCT02582684|E1|Reported Event|Arm 1: DTG 50 MG + 3TC 300 mg|"Dolutegravir: Participants were prescribed 50 mg of DTG orally daily~Lamivudine: Participants were prescribed 300 mg of 3TC orally daily."
17254|NCT02582632|B1|Baseline|Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir|ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
17255|NCT02582632|P1|Participant Flow|Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir|ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
17754|NCT02576639|O3|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
17257|NCT02582632|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir|ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
17258|NCT02582632|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir|ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
17259|NCT02582632|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir|ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
17260|NCT02582632|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir|ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
17261|NCT02582632|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir|ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
17262|NCT02582632|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir|ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
17263|NCT02582632|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir|ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
17264|NCT02582632|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir|ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
17265|NCT02582632|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir|ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
17266|NCT02582632|E1|Reported Event|Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir|ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
17267|NCT02582242|B3|Baseline|Total|Total of all reporting groups
17268|NCT02582242|B2|Baseline|Biphasic Insulin Aspart 30 (Twice Daily)|Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17269|NCT02582242|B1|Baseline|Biphasic Insulin Aspart 30 (Three Times Daily)|Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17270|NCT02582242|P2|Participant Flow|Biphasic Insulin Aspart 30 (Twice Daily)|Subjects received BIAsp 30 twice daily (BID); before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17271|NCT02582242|P1|Participant Flow|Biphasic Insulin Aspart 30 (Three Times Daily)|Subjects received biphasic insulin aspart 30 (BIAsp 30; a mixture of soluble insulin aspart [IAsp] 30% and protaminated IAsp 70%) three times daily (TID); before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as subcutaneous (s.c.; under the skin) injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal self-measured plasma glucose (SMPG) target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17272|NCT02582242|O2|Outcome|Biphasic Insulin Aspart 30 (Twice Daily)|Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17273|NCT02582242|O1|Outcome|Biphasic Insulin Aspart 30 (Three Times Daily)|Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17274|NCT02582242|O2|Outcome|Biphasic Insulin Aspart 30 (Twice Daily)|Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17275|NCT02582242|O1|Outcome|Biphasic Insulin Aspart 30 (Three Times Daily)|Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17276|NCT02582242|O2|Outcome|Biphasic Insulin Aspart 30 (Twice Daily)|Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17277|NCT02582242|O1|Outcome|Biphasic Insulin Aspart 30 (Three Times Daily)|Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17278|NCT02582242|O2|Outcome|Biphasic Insulin Aspart 30 (Twice Daily)|Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17279|NCT02582242|O1|Outcome|Biphasic Insulin Aspart 30 (Three Times Daily)|Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17280|NCT02582242|O2|Outcome|Biphasic Insulin Aspart 30 (Twice Daily)|Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17281|NCT02582242|O1|Outcome|Biphasic Insulin Aspart 30 (Three Times Daily)|Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17282|NCT02582242|O2|Outcome|Biphasic Insulin Aspart 30 (Twice Daily)|Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17283|NCT02582242|O1|Outcome|Biphasic Insulin Aspart 30 (Three Times Daily)|Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17284|NCT02582242|O2|Outcome|Biphasic Insulin Aspart 30 (Twice Daily)|Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17285|NCT02582242|O1|Outcome|Biphasic Insulin Aspart 30 (Three Times Daily)|Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17286|NCT02582242|O2|Outcome|Biphasic Insulin Aspart 30 (Twice Daily)|Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17287|NCT02582242|O1|Outcome|Biphasic Insulin Aspart 30 (Three Times Daily)|Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17288|NCT02582242|O2|Outcome|Biphasic Insulin Aspart 30 (Twice Daily)|Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17289|NCT02582242|O1|Outcome|Biphasic Insulin Aspart 30 (Three Times Daily)|Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17290|NCT02582242|O2|Outcome|Biphasic Insulin Aspart 30 (Twice Daily)|Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17330|NCT02581410|O2|Outcome|Control Group|Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
17331|NCT02581410|O1|Outcome|GSK1437173A Group|Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
17332|NCT02581410|O2|Outcome|Control Group|Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
17291|NCT02582242|O1|Outcome|Biphasic Insulin Aspart 30 (Three Times Daily)|Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17292|NCT02582242|O2|Outcome|Biphasic Insulin Aspart 30 (Twice Daily)|Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17293|NCT02582242|O1|Outcome|Biphasic Insulin Aspart 30 (Three Times Daily)|Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17294|NCT02582242|O2|Outcome|Biphasic Insulin Aspart 30 (Twice Daily)|Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17295|NCT02582242|O1|Outcome|Biphasic Insulin Aspart 30 (Three Times Daily)|Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17296|NCT02582242|O2|Outcome|Biphasic Insulin Aspart 30 (Twice Daily)|Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17297|NCT02582242|O1|Outcome|Biphasic Insulin Aspart 30 (Three Times Daily)|Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17298|NCT02582242|O2|Outcome|Biphasic Insulin Aspart 30 (Twice Daily)|Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17333|NCT02581410|O1|Outcome|GSK1437173A Group|Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
17334|NCT02581410|O2|Outcome|Control Group|Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
17335|NCT02581410|O1|Outcome|GSK1437173A Group|Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
17299|NCT02582242|O1|Outcome|Biphasic Insulin Aspart 30 (Three Times Daily)|Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17300|NCT02582242|O2|Outcome|Biphasic Insulin Aspart 30 (Twice Daily)|Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17301|NCT02582242|O1|Outcome|Biphasic Insulin Aspart 30 (Three Times Daily)|Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17302|NCT02582242|O2|Outcome|Biphasic Insulin Aspart 30 (Twice Daily)|Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17303|NCT02582242|O1|Outcome|Biphasic Insulin Aspart 30 (Three Times Daily)|Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17304|NCT02582242|O2|Outcome|Biphasic Insulin Aspart 30 (Twice Daily)|Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17305|NCT02582242|O1|Outcome|Biphasic Insulin Aspart 30 (Three Times Daily)|Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17306|NCT02582242|O2|Outcome|Biphasic Insulin Aspart 30 (Twice Daily)|Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17336|NCT02581410|O2|Outcome|Control Group|Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
17337|NCT02581410|O1|Outcome|GSK1437173A Group|Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
17338|NCT02581410|O2|Outcome|Control Group|Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
17307|NCT02582242|O1|Outcome|Biphasic Insulin Aspart 30 (Three Times Daily)|Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17308|NCT02582242|E2|Reported Event|Biphasic Insulin Aspart 30 (Twice Daily)|Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17309|NCT02582242|E1|Reported Event|Biphasic Insulin Aspart 30 (Three Times Daily)|Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator’s discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4−6.1 mmol/L (80−110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
17310|NCT02581475|B3|Baseline|Total|Total of all reporting groups
17311|NCT02581475|B2|Baseline|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
17312|NCT02581475|B1|Baseline|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
17313|NCT02581475|P2|Participant Flow|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
17314|NCT02581475|P1|Participant Flow|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
17315|NCT02581475|O2|Outcome|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
17316|NCT02581475|O1|Outcome|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
17317|NCT02581475|O2|Outcome|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
17318|NCT02581475|O1|Outcome|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
17319|NCT02581475|O2|Outcome|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
17320|NCT02581475|O1|Outcome|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
17321|NCT02581475|O2|Outcome|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
17322|NCT02581475|O1|Outcome|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
17323|NCT02581475|E2|Reported Event|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
17324|NCT02581475|E1|Reported Event|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
17325|NCT02581410|B3|Baseline|Total|Total of all reporting groups
17326|NCT02581410|B2|Baseline|Control Group|Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later).in this study.
17327|NCT02581410|B1|Baseline|GSK1437173A Group|Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
17328|NCT02581410|P2|Participant Flow|Control Group|Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later).in this study.
17329|NCT02581410|P1|Participant Flow|GSK1437173A Group|Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
17339|NCT02581410|O1|Outcome|GSK1437173A Group|Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
17340|NCT02581410|O2|Outcome|Control Group|Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
17341|NCT02581410|O1|Outcome|GSK1437173A Group|Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
17342|NCT02581410|O2|Outcome|Control Group|Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
17343|NCT02581410|O1|Outcome|GSK1437173A Group|Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
17344|NCT02581410|O2|Outcome|Control Group|Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
17345|NCT02581410|O1|Outcome|GSK1437173A Group|Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
17346|NCT02581410|E2|Reported Event|Control Group|Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
17347|NCT02581410|E1|Reported Event|GSK1437173A Group|Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
17348|NCT02580799|B1|Baseline|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
17349|NCT02580799|P1|Participant Flow|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
17350|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
17351|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
17352|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
17353|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
17354|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
17355|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
17356|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
17357|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
17358|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
17359|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
17360|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
17361|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
17362|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
17363|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
17364|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
17365|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
17366|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
17367|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
17368|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
17369|NCT02580799|E1|Reported Event|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
17370|NCT02580357|B4|Baseline|Total|Total of all reporting groups
17371|NCT02580357|B3|Baseline|GaAlAs Laser Therapy (LLLT) 30 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
17392|NCT02580240|B1|Baseline|Placebo|Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.
17393|NCT02580240|P2|Participant Flow|Hydrocortisone|Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).
17755|NCT02576639|O2|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
17372|NCT02580357|B2|Baseline|GaAlAs Laser Therapy (LLLT) 60 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
17373|NCT02580357|B1|Baseline|Low Level Laser Therapy (LLLT) Sham|"The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
17374|NCT02580357|P3|Participant Flow|GaAlAs Laser Therapy (LLLT) 30 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
17375|NCT02580357|P2|Participant Flow|GaAlAs Laser Therapy (LLLT) 60 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
17376|NCT02580357|P1|Participant Flow|Low Level Laser Therapy (LLLT) Sham|"The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
17377|NCT02580357|O3|Outcome|GaAlAs Laser Therapy (LLLT) 30 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
17378|NCT02580357|O2|Outcome|GaAlAs Laser Therapy (LLLT) 60 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
17379|NCT02580357|O1|Outcome|Low Level Laser Therapy (LLLT) Sham|"The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
17380|NCT02580357|O3|Outcome|GaAlAs Laser Therapy (LLLT) 30 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
17381|NCT02580357|O2|Outcome|GaAlAs Laser Therapy (LLLT) 60 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
17382|NCT02580357|O1|Outcome|Low Level Laser Therapy (LLLT) Sham|"The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
17383|NCT02580357|E3|Reported Event|GaAlAs Laser Therapy (LLLT) 30 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
17384|NCT02580357|E2|Reported Event|GaAlAs Laser Therapy (LLLT) 60 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
17385|NCT02580357|E1|Reported Event|Low Level Laser Therapy (LLLT) Sham|"The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
17386|NCT02580318|B1|Baseline|All Study Participants|participants drank beer to a BrAC level of 0.1 and then were instructed to do the following manipulations: poor effort, hyperventilation(immediate), hyperventilation (after 5 minutes), hyperventilation (after 10 minutes), drinking water (immediate), drinking water (after 5 minutes)
17387|NCT02580318|P1|Participant Flow|All Study Participants|participants drank beer to a BrAC level of 0.1 and then were instructed to do the following manipulations: poor effort, hyperventilation(immediate), hyperventilation (after 5 minutes), hyperventilation (after 10 minutes), drinking water (immediate), drinking water (after 5 minutes)
17388|NCT02580318|O1|Outcome|All Study Participants|participants drank beer to a BrAC level of 0.1 and then were instructed to do the following manipulations: poor effort, hyperventilation(immediate), hyperventilation (after 5 minutes), hyperventilation (after 10 minutes), drinking water (immediate), drinking water (after 5 minutes)
17389|NCT02580318|E1|Reported Event|All Study Participants|participants drank beer to a BrAC level of 0.1 and then were instructed to do the following manipulations: poor effort, hyperventilation(immediate), hyperventilation (after 5 minutes), hyperventilation (after 10 minutes), drinking water (immediate), drinking water (after 5 minutes)
17390|NCT02580240|B3|Baseline|Total|Total of all reporting groups
17391|NCT02580240|B2|Baseline|Hydrocortisone|Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).
18431|NCT02566759|B3|Baseline|Part 1: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1.
17394|NCT02580240|P1|Participant Flow|Placebo|Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.
17395|NCT02580240|O2|Outcome|Hydrocortisone|"Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).~Hydrocortisone: Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped)."
17396|NCT02580240|O1|Outcome|Placebo|"Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.~saline: Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar."
17397|NCT02580240|O2|Outcome|Hydrocortisone|"Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).~Hydrocortisone: Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped)."
17398|NCT02580240|O1|Outcome|Placebo|"Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.~saline: Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar."
17399|NCT02580240|E2|Reported Event|Hydrocortisone|Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).
17400|NCT02580240|E1|Reported Event|Placebo|Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.
17401|NCT02579603|B3|Baseline|Total|Total of all reporting groups
17402|NCT02579603|B2|Baseline|Nintedanib + Pirfenidone|Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily) in combination with pirfenidone. The pirfenidone dose was titrated up to 2403 mg daily according to the following schedule: 801 mg (1 capsule of 267 mg 3 times daily) from Visit 3 until the phone call visit ; 1602 mg daily (2 capsules of each 267 mg 3 times daily) after the phone call visit; 2403 mg daily (3 capsules of each 267 mg 3 times daily) starting at Visit 4 after the PK sampling had been performed.The dose of pirfenidone could have been reduced to 1 or 2 capsule(s) 3 times daily.
17403|NCT02579603|B1|Baseline|Nintedanib|Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily).
17404|NCT02579603|P2|Participant Flow|Nintedanib + Pirfenidone|Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily) in combination with pirfenidone. The pirfenidone dose was titrated up to 2403 mg daily according to the following schedule: 801 mg (1 capsule of 267 mg 3 times daily) from Visit 3 until the phone call visit ; 1602 mg daily (2 capsules of each 267 mg 3 times daily) after the phone call visit; 2403 mg daily (3 capsules of each 267 mg 3 times daily) starting at Visit 4 after the PK sampling had been performed.The dose of pirfenidone could have been reduced to 1 or 2 capsule(s) 3 times daily.
17405|NCT02579603|P1|Participant Flow|Nintedanib|Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily).
17406|NCT02579603|O1|Outcome|Nintedanib + Pirfenidone|Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily) in combination with pirfenidone. The pirfenidone dose was titrated up to 2403 mg daily according to the following schedule: 801 mg (1 capsule of 267 mg 3 times daily) from Visit 3 until the phone call visit ; 1602 mg daily (2 capsules of each 267 mg 3 times daily) after the phone call visit; 2403 mg daily (3 capsules of each 267 mg 3 times daily) starting at Visit 4 after the PK sampling had been performed.The dose of pirfenidone could have been reduced to 1 or 2 capsule(s) 3 times daily.
17407|NCT02579603|O2|Outcome|Nintedanib + Pirfenidone|Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily) in combination with pirfenidone. The pirfenidone dose was titrated up to 2403 mg daily according to the following schedule: 801 mg (1 capsule of 267 mg 3 times daily) from Visit 3 until the phone call visit ; 1602 mg daily (2 capsules of each 267 mg 3 times daily) after the phone call visit; 2403 mg daily (3 capsules of each 267 mg 3 times daily) starting at Visit 4 after the PK sampling had been performed.The dose of pirfenidone could have been reduced to 1 or 2 capsule(s) 3 times daily.
17408|NCT02579603|O1|Outcome|Nintedanib|Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily).
17409|NCT02579603|O2|Outcome|Nintedanib + Pirfenidone|Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily) in combination with pirfenidone. The pirfenidone dose was titrated up to 2403 mg daily according to the following schedule: 801 mg (1 capsule of 267 mg 3 times daily) from Visit 3 until the phone call visit ; 1602 mg daily (2 capsules of each 267 mg 3 times daily) after the phone call visit; 2403 mg daily (3 capsules of each 267 mg 3 times daily) starting at Visit 4 after the PK sampling had been performed.The dose of pirfenidone could have been reduced to 1 or 2 capsule(s) 3 times daily.
17410|NCT02579603|O1|Outcome|Nintedanib|Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily).
17438|NCT02578992|O1|Outcome|Neutral Head Position|The laryngeal view was graded by the observer with modified Cormack-Lehane grade after epiglottis was identified on the video monitor.
18479|NCT02566759|O3|Outcome|Part 1: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1.
17411|NCT02579603|E2|Reported Event|Nintedanib + Pirfenidone|Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily) in combination with pirfenidone. The pirfenidone dose was titrated up to 2403 mg daily according to the following schedule: 801 mg (1 capsule of 267 mg 3 times daily) from Visit 3 until the phone call visit ; 1602 mg daily (2 capsules of each 267 mg 3 times daily) after the phone call visit; 2403 mg daily (3 capsules of each 267 mg 3 times daily) starting at Visit 4 after the PK sampling had been performed.The dose of pirfenidone could have been reduced to 1 or 2 capsule(s) 3 times daily.
17412|NCT02579603|E1|Reported Event|Nintedanib|Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily).
17413|NCT02579057|B3|Baseline|Total|Total of all reporting groups
17414|NCT02579057|B2|Baseline|Furosemide Subcutaneous (SC)|"80 mg dose administered subcutaneously as 30 mg over the first hour and then as 12.5 mg per hour over the subsequent 4 hours (test treatment)~Furosemide Injection Solution (SCP-101)"
17415|NCT02579057|B1|Baseline|Furosemide IV|"Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment)~Furosemide Injection Solution, USP"
17416|NCT02579057|P2|Participant Flow|Furosemide Subcutaneous (SC)|"80 mg dose administered subcutaneously as 30 mg over the first hour and then as 12.5 mg per hour over the subsequent 4 hours (test treatment)~Furosemide Injection Solution (SCP-101)"
17417|NCT02579057|P1|Participant Flow|Furosemide IV|"Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment)~Furosemide Injection Solution, United States Pharmacopeia (USP)"
17418|NCT02579057|O2|Outcome|Furosemide SC|"80 mg dose administered subcutaneously as 30 mg over the first hour and then as 12.5 mg per hour over the subsequent 4 hours (test treatment)~Furosemide Injection Solution (SCP-101)"
17419|NCT02579057|O1|Outcome|Furosemide IV|"Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment)~Furosemide Injection Solution, USP"
17420|NCT02579057|O2|Outcome|Furosemide SC|"80 mg dose administered subcutaneously as 30 mg over the first hour and then as 12.5 mg per hour over the subsequent 4 hours (test treatment)~Furosemide Injection Solution (SCP-101)"
17421|NCT02579057|O1|Outcome|Furosemide IV|"Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment)~Furosemide Injection Solution, USP"
17422|NCT02579057|O2|Outcome|Furosemide SC|"80 mg dose administered subcutaneously as 30 mg over the first hour and then as 12.5 mg per hour over the subsequent 4 hours (test treatment)~Furosemide Injection Solution (SCP-101)"
17423|NCT02579057|O1|Outcome|Furosemide IV|"Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment)~Furosemide Injection Solution, USP"
17424|NCT02579057|O2|Outcome|Furosemide SC|"80 mg dose administered subcutaneously as 30 mg over the first hour and then as 12.5 mg per hour over the subsequent 4 hours (test treatment)~Furosemide Injection Solution (SCP-101)"
17425|NCT02579057|O1|Outcome|Furosemide IV|"Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment)~Furosemide Injection Solution, USP"
17426|NCT02579057|E2|Reported Event|Furosemide Subcutaneous (SC)|"80 mg dose administered subcutaneously as 30 mg over the first hour and then as 12.5 mg per hour over the subsequent 4 hours (test treatment)~Furosemide Injection Solution (SCP-101)"
17427|NCT02579057|E1|Reported Event|Furosemide IV|"Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment)~Furosemide Injection Solution, USP"
17428|NCT02578992|B3|Baseline|Total|Total of all reporting groups
17429|NCT02578992|B2|Baseline|Neutral Position|The patients’ head was placed in the neutral position and then the patient was intubated with Trachway by single-handed chin lift technique
17430|NCT02578992|B1|Baseline|Head-lift Position|"The patients’ head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients’ head with head in neutral position) and then the patient was intubated with Trachway by single-handed chin lift technique~Head-lift position: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation.~7cm high pillow: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation."
17431|NCT02578992|P2|Participant Flow|Neutral Position|The patients’ head was placed in the neutral position.An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique
17432|NCT02578992|P1|Participant Flow|Head-lift Position|"The patients’ head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients’ head with head in neutral position). An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique~Head-lift position: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation.~7cm high pillow: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation."
17433|NCT02578992|O2|Outcome|Head-lift Position|All patients were asked to rate the degree of sore throat, using a visual analogue scale after anesthesia emergence in the post-anesthesia care unit
17434|NCT02578992|O1|Outcome|Neutral Head Position|All patients were asked to rate the degree of sore throat, using a visual analogue scale after anesthesia emergence in the post-anesthesia care unit
17435|NCT02578992|O2|Outcome|Head-lift Position|Hemodynamic variables were recorded 3 min before, and 1, 3, and 5 min after intubation.
17436|NCT02578992|O1|Outcome|Neutral Head Position|Hemodynamic variables were recorded 3 min before, and 1, 3, and 5 min after intubation.
17437|NCT02578992|O2|Outcome|Head-lift Position|The laryngeal view was graded by the observer with modified Cormack-Lehane grade after epiglottis was identified on the video monitor.
26764|NCT02480582|O3|Outcome|No Food|No food provided, just water
17439|NCT02578992|O2|Outcome|Neutral Position|The patients’ head was placed in the neutral position.An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique
17440|NCT02578992|O1|Outcome|Head-lift Position|"The patients’ head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients’ head with head in neutral position). An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique~Head-lift position: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation.~7cm high pillow: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation."
17441|NCT02578992|E2|Reported Event|Neutral Position|The patients’ head was placed in the neutral position.An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique
17442|NCT02578992|E1|Reported Event|Head-lift Position|"The patients’ head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients’ head with head in neutral position). An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique~Head-lift position: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation.~7cm high pillow: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation."
17443|NCT02578706|B4|Baseline|Total|Total of all reporting groups
17444|NCT02578706|B3|Baseline|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17445|NCT02578706|B2|Baseline|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17446|NCT02578706|B1|Baseline|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17447|NCT02578706|P3|Participant Flow|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17448|NCT02578706|P2|Participant Flow|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17449|NCT02578706|P1|Participant Flow|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17450|NCT02578706|O3|Outcome|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17451|NCT02578706|O2|Outcome|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17452|NCT02578706|O1|Outcome|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17453|NCT02578706|O3|Outcome|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17454|NCT02578706|O2|Outcome|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17455|NCT02578706|O1|Outcome|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17456|NCT02578706|O3|Outcome|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17457|NCT02578706|O2|Outcome|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17458|NCT02578706|O1|Outcome|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17459|NCT02578706|O3|Outcome|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17460|NCT02578706|O2|Outcome|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17461|NCT02578706|O1|Outcome|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17462|NCT02578706|O3|Outcome|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17629|NCT02577016|B2|Baseline|Placebo + Ipragliflozin|Placebo to sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
17463|NCT02578706|O2|Outcome|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17464|NCT02578706|O1|Outcome|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17465|NCT02578706|O3|Outcome|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17466|NCT02578706|O2|Outcome|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17467|NCT02578706|O1|Outcome|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17468|NCT02578706|O3|Outcome|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17469|NCT02578706|O2|Outcome|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17470|NCT02578706|O1|Outcome|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17471|NCT02578706|O3|Outcome|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17472|NCT02578706|O2|Outcome|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17473|NCT02578706|O1|Outcome|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17474|NCT02578706|O3|Outcome|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17475|NCT02578706|O2|Outcome|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17476|NCT02578706|O1|Outcome|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17477|NCT02578706|O3|Outcome|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17478|NCT02578706|O2|Outcome|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17479|NCT02578706|O1|Outcome|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17480|NCT02578706|O3|Outcome|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17481|NCT02578706|O2|Outcome|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17482|NCT02578706|O1|Outcome|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17483|NCT02578706|O3|Outcome|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17484|NCT02578706|O2|Outcome|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17485|NCT02578706|O1|Outcome|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17486|NCT02578706|O3|Outcome|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17487|NCT02578706|O2|Outcome|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17488|NCT02578706|O1|Outcome|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17489|NCT02578706|O3|Outcome|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17490|NCT02578706|O2|Outcome|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17491|NCT02578706|O1|Outcome|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17492|NCT02578706|O3|Outcome|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17493|NCT02578706|O2|Outcome|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17494|NCT02578706|O1|Outcome|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17495|NCT02578706|O3|Outcome|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17496|NCT02578706|O2|Outcome|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17497|NCT02578706|O1|Outcome|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17498|NCT02578706|O3|Outcome|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17499|NCT02578706|O2|Outcome|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17500|NCT02578706|O1|Outcome|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17501|NCT02578706|O3|Outcome|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17502|NCT02578706|O2|Outcome|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17503|NCT02578706|O1|Outcome|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17504|NCT02578706|O3|Outcome|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17505|NCT02578706|O2|Outcome|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17506|NCT02578706|O1|Outcome|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17507|NCT02578706|O3|Outcome|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17508|NCT02578706|O2|Outcome|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17509|NCT02578706|O1|Outcome|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17510|NCT02578706|O3|Outcome|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17511|NCT02578706|O2|Outcome|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17512|NCT02578706|O1|Outcome|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17513|NCT02578706|O3|Outcome|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17514|NCT02578706|O2|Outcome|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17515|NCT02578706|O1|Outcome|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17516|NCT02578706|O3|Outcome|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17517|NCT02578706|O2|Outcome|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17518|NCT02578706|O1|Outcome|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17519|NCT02578706|O3|Outcome|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17520|NCT02578706|O2|Outcome|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17521|NCT02578706|O1|Outcome|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17522|NCT02578706|E3|Reported Event|Placebos Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17523|NCT02578706|E2|Reported Event|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17524|NCT02578706|E1|Reported Event|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
17525|NCT02578316|B1|Baseline|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for pharmacokinetic (PK) analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
17526|NCT02578316|P1|Participant Flow|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity"
17527|NCT02578316|O1|Outcome|14C^Lenvatinib/Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
17528|NCT02578316|O1|Outcome|14C^Lenvatinib/Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
17529|NCT02578316|O1|Outcome|14^C-Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
17530|NCT02578316|O1|Outcome|14^C-Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
17592|NCT02577445|E2|Reported Event|CSA Patients With remedē System|For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
17593|NCT02577445|E1|Reported Event|CSA Patients NOT Implanted With remedē® System|For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment.
17594|NCT02577315|B3|Baseline|Total|Total of all reporting groups
17531|NCT02578316|O1|Outcome|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
17532|NCT02578316|O1|Outcome|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
17533|NCT02578316|O1|Outcome|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
17534|NCT02578316|O2|Outcome|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
17535|NCT02578316|O1|Outcome|14^C-Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
17536|NCT02578316|O2|Outcome|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
17537|NCT02578316|O1|Outcome|14^C-Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
17538|NCT02578316|O2|Outcome|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
17539|NCT02578316|O1|Outcome|14^C-Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
17540|NCT02578316|O2|Outcome|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
17541|NCT02578316|O1|Outcome|14^C-Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
17542|NCT02578316|O2|Outcome|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
17543|NCT02578316|O1|Outcome|14^C-Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
17544|NCT02578316|O2|Outcome|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
17545|NCT02578316|O1|Outcome|14^C-Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
17595|NCT02577315|B2|Baseline|Empagliflozin + Metformin / Fixed Dose Combination (FDC)|Participants first received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose, then they received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal. Single dose in each treatment period was separated by a washout phase of at least 5 days between drug administrations.
17630|NCT02577016|B1|Baseline|Sitagliptin + Ipragliflozin|Sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
18480|NCT02566759|O2|Outcome|Part 1: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1.
17546|NCT02578316|O2|Outcome|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for pharmacokinetic (PK) analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
17547|NCT02578316|O1|Outcome|14^C-Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
17548|NCT02578316|E1|Reported Event|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for pharmacokinetic (PK) analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity"
17549|NCT02578199|B1|Baseline|Motivational Interviewing and Nutrition|"Motivational interviewing and nutritional counseling.~motivational interviewing and nutrition: Motivational Interviewing and Nutritional Counseling"
17550|NCT02578199|P1|Participant Flow|Motivational Interviewing and Nutrition|"Motivational interviewing and nutritional counseling.~motivational interviewing and nutrition: Motivational Interviewing and Nutritional Counseling"
17551|NCT02578199|O1|Outcome|Motivational Interviewing and Nutrition|"Motivational interviewing and nutritional counseling.~motivational interviewing and nutrition: Motivational Interviewing and Nutritional Counseling"
17552|NCT02578199|O1|Outcome|Motivational Interviewing and Nutrition|"Motivational interviewing and nutritional counseling.~motivational interviewing and nutrition: Motivational Interviewing and Nutritional Counseling"
17553|NCT02578199|E1|Reported Event|Motivational Interviewing and Nutrition|"Motivational interviewing and nutritional counseling.~motivational interviewing and nutrition: Motivational Interviewing and Nutritional Counseling"
17554|NCT02578186|B1|Baseline|Entire Study Population|Entire Study Population Includes groups that received Placebo and Drug First
17555|NCT02578186|P2|Participant Flow|Placebo, Then Diphenhydramine Hydrochloride|"Placebo elixir taken when subjects had trouble falling asleep~Placebo: Placebo once a day at bedtime in first intervention period and DPH (50 mg) once a day at bedtime for the second intervention period (after 5 day washout period)."
17556|NCT02578186|P1|Participant Flow|Diphenhydramine Hydrochloride, Then Placebo|"Diphenhydramine (50 mg) elixir taken when subjects had trouble falling asleep~Diphenhydramine Hydrochloride: DPH (50 mg) once a day at bedtime in first intervention period and Placebo once a day at bedtime for the second intervention period (after 5 day washout period)."
17557|NCT02578186|O2|Outcome|Placebo|"Placebo elixir taken when subjects had trouble falling asleep~Placebo: 30 mL at bedtime"
17558|NCT02578186|O1|Outcome|Diphenhydramine Hydrochloride|"Diphenhydramine (50 mg) elixir taken when subjects had trouble falling asleep~Diphenhydramine Hydrochloride: 30 mL at bedtime"
17559|NCT02578186|E2|Reported Event|Placebo|"Placebo elixir taken when subjects had trouble falling asleep~Placebo: 30 mL at bedtime"
17560|NCT02578186|E1|Reported Event|Diphenhydramine Hydrochloride|"Diphenhydramine (50 mg) elixir taken when subjects had trouble falling asleep~Diphenhydramine Hydrochloride: 30 mL at bedtime"
17561|NCT02577718|B1|Baseline|NiCE Lock|
17562|NCT02577718|P1|Participant Flow|NiCE Lock|
17563|NCT02577718|O2|Outcome|Off NiCE Lock|Days patients did not receive NiCE Lock
17564|NCT02577718|O1|Outcome|NiCE Lock|Days when patients received NiCE Lock
17565|NCT02577718|O1|Outcome|NiCE Lock|All patients who received at least one dose
17566|NCT02577718|E1|Reported Event|NiCE Lock|Patients had days they received NiCE Lock and days they did not receive NiCE Lock (off-Lock days). NiCE Lock was a combination of three different agents so combined results are presented. Most patients received NiCE Lock with Nitroglycerin 30 μg/ml.
17567|NCT02577510|B1|Baseline|All Participants|
17568|NCT02577510|P2|Participant Flow|Ultrasound Guided Xylocaine Injection|Nerve Injection - Ultrasound: For the ultrasound nerve injection group, after skin disinfection, the inguinal region of patients will be scanned using a high-frequency (6 to 13 MHz) linear array transducer covered with a sterile plastic cover. An ultrasound image showing the inguinal ligament and anterior superior iliac spine (ASIS) will be obtained. Using an out-of-plane technique, a 22-gauge nerve block needle will be inserted 1-2 cm medial to ASIS. The needle will be advanced unt
17617|NCT02577107|P1|Participant Flow|Ranibizumab 0.5 mg|Three monthly injections of 0.5mg Ranibizumab
17618|NCT02577107|O2|Outcome|Conbercept 0.5 mg|Three monthly injections of 0.5mg Conbercept
17619|NCT02577107|O1|Outcome|Ranibizumab 0.5 mg|Three monthly injections of 0.5mg Ranibizumab
17620|NCT02577107|O2|Outcome|Conbercept 0.5 mg|Three monthly injections of 0.5mg Conbercept
17621|NCT02577107|O1|Outcome|Ranibizumab 0.5 mg|Three monthly injections of 0.5mg Ranibizumab
17569|NCT02577510|P1|Participant Flow|Nerve Stimulation- Xylocaine Injection|"Anesthesia of the lateral femoral cutaneous nerve using local anesthetic will be randomly assigned on the right or left side to receive nerve stimulation-xylocaine or ultrasound guided -xylocaine injections in all patients. One patient will therefore have both nerve stimulation AND ultrasound guided injections, only the side of the injection will be randomly assigned to one of the two modalities. Once one technique has been used to freeze one side, the other side will be frozen using the other technique.~Nerve Injection- Nerve Stimulator: For the neurostimulation nerve injection technique, the initial puncture site will be located medial to the anterosuperior iliac spine, just caudal to the inguinal ligament [7]. The 22-gauge insulated needle will be connected to a stimulator set at a current of 1.5 mA, a pulse width of 300 ms and a frequency of 2 Hz. A paresthesia referred to the lateral aspect of the thigh at a minimal stimulatory threshold of 0.6 mA (0.3ms) will be sought prior"
17570|NCT02577510|O2|Outcome|Ultrasound Guided Xylocaine Injection|Nerve Injection - Ultrasound: For the ultrasound nerve injection group, after skin disinfection, the inguinal region of patients will be scanned using a high-frequency (6 to 13 MHz) linear array transducer covered with a sterile plastic cover. An ultrasound image showing the inguinal ligament and anterior superior iliac spine (ASIS) will be obtained. Using an out-of-plane technique, a 22-gauge nerve block needle will be inserted 1-2 cm medial to ASIS. The needle will be advanced unt
17571|NCT02577510|O1|Outcome|Nerve Stimulation- Xylocaine Injection|"Anesthesia of the lateral femoral cutaneous nerve using local anesthetic will be randomly assigned on the right or left side to receive nerve stimulation-xylocaine or ultrasound guided -xylocaine injections in all patients. One patient will therefore have both nerve stimulation AND ultrasound guided injections, only the side of the injection will be randomly assigned to one of the two modalities. Once one technique has been used to freeze one side, the other side will be frozen using the other technique.~Nerve Injection- Nerve Stimulator: For the neurostimulation nerve injection technique, the initial puncture site will be located medial to the anterosuperior iliac spine, just caudal to the inguinal ligament [7]. The 22-gauge insulated needle will be connected to a stimulator set at a current of 1.5 mA, a pulse width of 300 ms and a frequency of 2 Hz. A paresthesia referred to the lateral aspect of the thigh at a minimal stimulatory threshold of 0.6 mA (0.3ms) will be sought prior"
17572|NCT02577510|O2|Outcome|Ultrasound|
17573|NCT02577510|O1|Outcome|Nerve|
17574|NCT02577510|O2|Outcome|Ultrasound|
17575|NCT02577510|O1|Outcome|Nerve Stimulation|
17576|NCT02577510|O2|Outcome|Ultrasound|
17577|NCT02577510|O1|Outcome|Nerve Stimulation|
17578|NCT02577510|E2|Reported Event|Nerve Stimulation Guided Xylocaine Injection|Adverse event collected for this side with this intervention.
17579|NCT02577510|E1|Reported Event|Ultrasound Guided Xylocaine Injection|Adverse event collected for this side with this intervention.
17580|NCT02577445|B3|Baseline|Total|Total of all reporting groups
17581|NCT02577445|B2|Baseline|CSA Patients With remedē System|For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
17582|NCT02577445|B1|Baseline|CSA Patients NOT Implanted With remedē® System|For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment.
17583|NCT02577445|P2|Participant Flow|CSA Patients With remedē System|"For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.~Patients will be asked to complete quality of life questionnaires at baseline and during follow-up visits.~Patients will be evaluated at the time of therapy activation which may be followed by one or more titration visits. Patient follow-ups will be programmed at 6 and 12 months, and yearly, up to 5 years post-implant, until the last patients reach their 2-year follow-up.~Echocardiogram for patients with reduced ejection fraction (≤ 45%) and follow-up respiratory polygraphy are considered standard of care, however, to ensure sufficient data, related to the study objectives, are being collected, baseline and 12-months echocardiogram for a subgroup of patients and respiratory polygraphy at 12-month follow-up for all patients must be done when participating in this study:"
17584|NCT02577445|P1|Participant Flow|CSA Patients NOT Implanted With remedē System|For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment.
17585|NCT02577445|O2|Outcome|CSA Patients With remedē System|For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
17586|NCT02577445|O1|Outcome|CSA Patients NOT Implanted With remedē® System|For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment.
17587|NCT02577445|O1|Outcome|CSA Patients NOT Implanted With remedē® System|For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment.
17588|NCT02577445|O1|Outcome|CSA Patients With remedē System|For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
17589|NCT02577445|O1|Outcome|CSA Patients With remedē System|For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
17590|NCT02577445|O1|Outcome|CSA Patients With remedē System|For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
17591|NCT02577445|O1|Outcome|CSA Patients With remedē System|For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
17622|NCT02577107|O2|Outcome|Conbercept 0.5 mg|Three monthly injections of 0.5mg Conbercept
17596|NCT02577315|B1|Baseline|Fixed Dose Combination (FDC) / Empagliflozin + Metformin|Participants first received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC), then they received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal. Single dose in each treatment period was separated by a washout phase of at least 5 days between drug administrations.
17597|NCT02577315|P2|Participant Flow|Empagliflozin + Metformin / Fixed Dose Combination (FDC)|Participants first received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose, then they received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal. Single dose in each treatment period was separated by a washout phase of at least 5 days between drug administrations.
17598|NCT02577315|P1|Participant Flow|Fixed Dose Combination (FDC) / Empagliflozin + Metformin|Participants first received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC), then they received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal. Single dose in each treatment period was separated by a washout phase of at least 5 days between drug administrations.
17599|NCT02577315|O2|Outcome|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
17600|NCT02577315|O1|Outcome|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
17601|NCT02577315|O2|Outcome|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
17602|NCT02577315|O1|Outcome|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
17603|NCT02577315|O2|Outcome|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
17604|NCT02577315|O1|Outcome|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
17605|NCT02577315|O2|Outcome|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
17606|NCT02577315|O1|Outcome|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
17607|NCT02577315|O2|Outcome|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
17608|NCT02577315|O1|Outcome|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
17609|NCT02577315|O2|Outcome|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
17610|NCT02577315|O1|Outcome|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
17611|NCT02577315|E2|Reported Event|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
17612|NCT02577315|E1|Reported Event|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
17613|NCT02577107|B3|Baseline|Total|Total of all reporting groups
17614|NCT02577107|B2|Baseline|Conbercept 0.5 mg|Three monthly injections of 0.5mg Conbercept
17615|NCT02577107|B1|Baseline|Ranibizumab 0.5 mg|Three monthly injections of 0.5mg Ranibizumab
17616|NCT02577107|P2|Participant Flow|Conbercept 0.5 mg|Three monthly injections of 0.5mg Conbercept
17631|NCT02577016|P2|Participant Flow|Placebo + Ipragliflozin|Placebo to sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
17632|NCT02577016|P1|Participant Flow|Sitagliptin + Ipragliflozin|Sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
17633|NCT02577016|O2|Outcome|Placebo + Ipragliflozin|Placebo to sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
17634|NCT02577016|O1|Outcome|Sitagliptin + Ipragliflozin|Sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
17635|NCT02577016|O2|Outcome|Placebo + Ipragliflozin|Placebo to sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
17636|NCT02577016|O1|Outcome|Sitagliptin + Ipragliflozin|Sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
17637|NCT02577016|O2|Outcome|Placebo + Ipragliflozin|Placebo to sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
17638|NCT02577016|O1|Outcome|Sitagliptin + Ipragliflozin|Sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
17639|NCT02577016|O2|Outcome|Placebo + Ipragliflozin|Placebo to sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
17640|NCT02577016|O1|Outcome|Sitagliptin + Ipragliflozin|Sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
17641|NCT02577016|O2|Outcome|Placebo + Ipragliflozin|Placebo to sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
17642|NCT02577016|O1|Outcome|Sitagliptin + Ipragliflozin|Sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
17643|NCT02577016|O2|Outcome|Placebo + Ipragliflozin|Placebo to sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
17644|NCT02577016|O1|Outcome|Sitagliptin + Ipragliflozin|Sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
17645|NCT02577016|E2|Reported Event|Placebo + Ipragliflozin|Placebo to sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
17646|NCT02577016|E1|Reported Event|Sitagliptin + Ipragliflozin|Sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
17647|NCT02577003|B3|Baseline|Total|Total of all reporting groups
17648|NCT02577003|B2|Baseline|Placebo + Sitagliptin|Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
17649|NCT02577003|B1|Baseline|Ipragliflozin + Sitagliptin|Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
17650|NCT02577003|P2|Participant Flow|Placebo + Sitagliptin|Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
17651|NCT02577003|P1|Participant Flow|Ipragliflozin + Sitagliptin|Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
17652|NCT02577003|O2|Outcome|Placebo + Sitagliptin|Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
17653|NCT02577003|O1|Outcome|Ipragliflozin + Sitagliptin|Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
17654|NCT02577003|O2|Outcome|Placebo + Sitagliptin|Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
17655|NCT02577003|O1|Outcome|Ipragliflozin + Sitagliptin|Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
17656|NCT02577003|O2|Outcome|Placebo + Sitagliptin|Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
17657|NCT02577003|O1|Outcome|Ipragliflozin + Sitagliptin|Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
17658|NCT02577003|O2|Outcome|Placebo + Sitagliptin|Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
17659|NCT02577003|O1|Outcome|Ipragliflozin + Sitagliptin|Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
17660|NCT02577003|O2|Outcome|Placebo + Sitagliptin|Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
17661|NCT02577003|O1|Outcome|Ipragliflozin + Sitagliptin|Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
17662|NCT02577003|O2|Outcome|Placebo + Sitagliptin|Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
17663|NCT02577003|O1|Outcome|Ipragliflozin + Sitagliptin|Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
17664|NCT02577003|O2|Outcome|Placebo + Sitagliptin|Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
17665|NCT02577003|O1|Outcome|Ipragliflozin + Sitagliptin|Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
17666|NCT02577003|E2|Reported Event|Placebo + Sitagliptin|Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
17667|NCT02577003|E1|Reported Event|Ipragliflozin + Sitagliptin|Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
17668|NCT02576938|B4|Baseline|Total|Total of all reporting groups
17669|NCT02576938|B3|Baseline|4mg Baricitinib|4mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
17670|NCT02576938|B2|Baseline|2 mg Baricitinib|2mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
17671|NCT02576938|B1|Baseline|Placebo|Placebo administered orally (PO) once daily (QD), for 16 weeks Triamcinolone 0.1% applied topically also permitted throughout study.
17672|NCT02576938|P3|Participant Flow|4 mg Baricitinib|4 mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
17673|NCT02576938|P2|Participant Flow|2 mg Baricitinib|2 milligram (mg) Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
17724|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
17674|NCT02576938|P1|Participant Flow|Placebo|Placebo administered orally (PO) once daily (QD), for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
17675|NCT02576938|O2|Outcome|4mg Baricitinib|4mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
17676|NCT02576938|O1|Outcome|2 mg Baricitinib|2mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
17677|NCT02576938|O3|Outcome|4mg Baricitinib|4mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
17678|NCT02576938|O2|Outcome|2 mg Baricitinib|2mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
17679|NCT02576938|O1|Outcome|Placebo|Placebo administered orally (PO) once daily (QD), for 16 weeks Triamcinolone 0.1% applied topically also permitted throughout study.
17680|NCT02576938|O3|Outcome|4mg Baricitinib|4mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
17681|NCT02576938|O2|Outcome|2 mg Baricitinib|2mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
17682|NCT02576938|O1|Outcome|Placebo|Placebo administered orally (PO) once daily (QD), for 16 weeks Triamcinolone 0.1% applied topically also permitted throughout study.
17683|NCT02576938|O3|Outcome|4mg Baricitinib|4mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
17684|NCT02576938|O2|Outcome|2 mg Baricitinib|2mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
17685|NCT02576938|O1|Outcome|Placebo|Placebo administered orally (PO) once daily (QD), for 16 weeks Triamcinolone 0.1% applied topically also permitted throughout study.
17686|NCT02576938|O3|Outcome|4mg Baricitinib|4mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
17687|NCT02576938|O2|Outcome|2 mg Baricitinib|2mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
17688|NCT02576938|O1|Outcome|Placebo|Placebo administered orally (PO) once daily (QD), for 16 weeks Triamcinolone 0.1% applied topically also permitted throughout study.
17689|NCT02576938|O3|Outcome|4mg Baricitinib|4mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
17690|NCT02576938|O2|Outcome|2 mg Baricitinib|2mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
17691|NCT02576938|O1|Outcome|Placebo|Placebo administered orally (PO) once daily (QD), for 16 weeks Triamcinolone 0.1% applied topically also permitted throughout study.
17692|NCT02576938|O3|Outcome|4mg Baricitinib|4mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
17693|NCT02576938|O2|Outcome|2 mg Baricitinib|2mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
17694|NCT02576938|O1|Outcome|Placebo|Placebo administered orally (PO) once daily (QD), for 16 weeks Triamcinolone 0.1% applied topically also permitted throughout study.
17695|NCT02576938|O3|Outcome|4mg Baricitinib|4mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
17696|NCT02576938|O2|Outcome|2 mg Baricitinib|2mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
17697|NCT02576938|O1|Outcome|Placebo|Placebo administered orally (PO) once daily (QD), for 16 weeks Triamcinolone 0.1% applied topically also permitted throughout study.
17698|NCT02576938|E3|Reported Event|4mg Baricitinib|4mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
17699|NCT02576938|E2|Reported Event|2 mg Baricitinib|2mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
17700|NCT02576938|E1|Reported Event|Placebo|Placebo administered orally (PO) once daily (QD), for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
17701|NCT02576639|B6|Baseline|Total|Total of all reporting groups
17702|NCT02576639|B5|Baseline|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
17703|NCT02576639|B4|Baseline|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
17704|NCT02576639|B3|Baseline|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
17705|NCT02576639|B2|Baseline|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
17706|NCT02576639|B1|Baseline|Placebo|Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
17707|NCT02576639|P5|Participant Flow|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
17708|NCT02576639|P4|Participant Flow|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
17709|NCT02576639|P3|Participant Flow|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
17710|NCT02576639|P2|Participant Flow|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
17711|NCT02576639|P1|Participant Flow|Placebo|Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
17712|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
17713|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
17714|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
17715|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
17716|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
17717|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
17718|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
17719|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
17720|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
17721|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
17722|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
17723|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
17756|NCT02576639|O1|Outcome|Placebo|Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
17757|NCT02576639|O5|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
17758|NCT02576639|O4|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
17759|NCT02576639|O3|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
17760|NCT02576639|O2|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
17761|NCT02576639|O1|Outcome|Placebo|Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
17762|NCT02576639|E5|Reported Event|CNP520 85mg|CNP520 85 mg was taken qd orally for 13 weeks.
17763|NCT02576639|E4|Reported Event|CNP520 35mg|CNP520 35 mg was taken qd orally for 13 weeks.
17764|NCT02576639|E3|Reported Event|CNP520 10mg|CNP520 10 mg was taken qd orally for 13 weeks.
17765|NCT02576639|E2|Reported Event|CNP520 2mg|CNP520 2 mg was taken qd orally for 13 weeks.
17766|NCT02576639|E1|Reported Event|Placebo|Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
17767|NCT02576535|B1|Baseline|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
17768|NCT02576535|P1|Participant Flow|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
17769|NCT02576535|O1|Outcome|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
17770|NCT02576535|O1|Outcome|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
17771|NCT02576535|O1|Outcome|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
17772|NCT02576535|O1|Outcome|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
17773|NCT02576535|O1|Outcome|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
17774|NCT02576535|O1|Outcome|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
17775|NCT02576535|E1|Reported Event|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
17776|NCT02576249|B3|Baseline|Total|Total of all reporting groups
17777|NCT02576249|B2|Baseline|Saline and Methylprednisolone|0.9% normal saline and methylprednisolone knee joint injection
17778|NCT02576249|B1|Baseline|Ropivacaine and Methylprednisolone|0.2% ropivacaine and methylprednisolone knee joint injection
17779|NCT02576249|P2|Participant Flow|Saline and Methylprednisolone|0.9% normal saline and methylprednisolone knee joint injection
17780|NCT02576249|P1|Participant Flow|Ropivacaine and Methylprednisolone|0.2% ropivacaine and methylprednisolone knee joint injection
17781|NCT02576249|O2|Outcome|Saline and Methylprednisolone|0.9% normal saline and methylprednisolone knee joint injection
17782|NCT02576249|O1|Outcome|Ropivacaine and Methylprednisolone|0.2% ropivacaine and methylprednisolone knee joint injection
17783|NCT02576249|O2|Outcome|Saline and Methylprednisolone|0.9% normal saline and methylprednisolone knee joint injection
17784|NCT02576249|O1|Outcome|Ropivacaine and Methylprednisolone|0.2% ropivacaine and methylprednisolone knee joint injection
17785|NCT02576249|O2|Outcome|Saline and Methylprednisolone|0.9% normal saline and methylprednisolone knee joint injection
17786|NCT02576249|O1|Outcome|Ropivacaine and Methylprednisolone|0.2% ropivacaine and methylprednisolone knee joint injection
17787|NCT02576249|E2|Reported Event|Saline and Methylprednisolone|0.9% normal saline and methylprednisolone knee joint injection
17788|NCT02576249|E1|Reported Event|Ropivacaine and Methylprednisolone|0.2% ropivacaine and methylprednisolone knee joint injection
17789|NCT02576145|B3|Baseline|Total|Total of all reporting groups
17790|NCT02576145|B2|Baseline|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
18257|NCT02569658|O1|Outcome|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.~Tranexamic Acid"
17791|NCT02576145|B1|Baseline|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
17792|NCT02576145|P2|Participant Flow|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
17793|NCT02576145|P1|Participant Flow|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
17794|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
17795|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
17796|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
17797|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
17798|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
17799|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
17800|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
17801|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
17802|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
17803|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
17804|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
17805|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
17806|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
17807|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
17808|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
17893|NCT02574845|E1|Reported Event|REF Alone|The subjects received the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
26968|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
17809|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
17810|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
17811|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
17812|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
17813|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
17814|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
17815|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
17816|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
17817|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
17818|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
17819|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
17820|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
17821|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
17822|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
17823|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
17824|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
17825|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
17826|NCT02576145|E2|Reported Event|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
17933|NCT02573467|B2|Baseline|BYM338/Bimagrumab 3 mg/kg|Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..
28119|NCT02468414|B3|Baseline|Total|Total of all reporting groups
17827|NCT02576145|E1|Reported Event|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
17828|NCT02576041|B1|Baseline|Placebo (run-in); Bilastine|"At V0, the enrolled patient received the complete drug-kit and started a 7 (+3)-day wash-out period with placebo. At the end of the 7 (+3)-days of placebo-treatment period, patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3)-day treatment period with active treatment (bilastine).~Bilastine: Bilastine tablets once a day for 7+3 days~Placebo: Placebo tablets once a day during 7+3 days run in period"
17829|NCT02576041|P1|Participant Flow|Placebo (run-in); Bilastine|"At V0, the enrolled patient received the complete drug-kit and started a 7 (+3)-day wash-out period with placebo. At the end of the 7 (+3)-days of placebo-treatment period, patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3)-day treatment period with active treatment (bilastine).~Bilastine: Bilastine tablets once a day for 7+3 days~Placebo: Placebo tablets once a day during 7+3 days run in period"
17830|NCT02576041|O1|Outcome|Bilastine|Patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3) day treatment period with Bilastine
17831|NCT02576041|O1|Outcome|Bilastine|Patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3) day treatment period with Bilastine
17832|NCT02576041|O1|Outcome|Bilastine|Patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3) day treatment period with Bilastine
17833|NCT02576041|E1|Reported Event|Placebo (run-in); Bilastine|"At V0, the enrolled patient received the complete drug-kit and started a 7 (+3)-day wash-out period with placebo. At the end of the 7 (+3)-days of placebo-treatment period, patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3)-day treatment period with active treatment (bilastine).~Bilastine: Bilastine tablets once a day for 7+3 days~Placebo: Placebo tablets once a day during 7+3 days run in period"
17834|NCT02575911|B1|Baseline|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
17835|NCT02575911|P1|Participant Flow|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
17836|NCT02575911|O2|Outcome|LenSx - 3 Months Postoperative|LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative
17837|NCT02575911|O1|Outcome|LenSx - 1 Month Postoperative|LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 1 month post-operative
17838|NCT02575911|O1|Outcome|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
17839|NCT02575911|O3|Outcome|LenSx - Month 3 Postoperative|LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative
17840|NCT02575911|O2|Outcome|LenSx - Month 1 Postoperative|LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 1 month post-operative
17841|NCT02575911|O1|Outcome|Baseline|Prior to LASIK surgery
17842|NCT02575911|O2|Outcome|LenSx - Month 3 Postoperative|LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative
17843|NCT02575911|O1|Outcome|LenSx - Month 1 Postoperative|LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 1 month post-operative
17844|NCT02575911|O1|Outcome|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
17845|NCT02575911|O1|Outcome|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
17846|NCT02575911|O1|Outcome|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
17847|NCT02575911|O1|Outcome|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
17848|NCT02575911|O1|Outcome|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
17849|NCT02575911|O1|Outcome|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
17850|NCT02575911|E2|Reported Event|LenSx|All subjects treated with LASIK surgery in both eyes using LenSx® Femtosecond Laser System
17851|NCT02575911|E1|Reported Event|Pre-treatment|All who consented to participate in the study prior to the initiation of study treatment
17852|NCT02574858|B1|Baseline|QRH-886620|"The first three subjects will squirt via syringe into their mouths (po) 4.2 mg (2.1ml) mg of reconstituted (with 5 ml of 0.9% saline) QRH-882260 heptapeptide (~100 µM concentration). They will be asked to wait 5 minutes and then drink at least 4-8oz of tap water. The remaining seven subjects will receive (squirted via syringe into their mouths) 1mg (5ml) of reconstituted (with 5ml of 0.9% saline) QRH-882260 heptapeptide (~100 µM concentration).~QRH-882260: The investigational agent to be used in this study is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached to Cy5."
17853|NCT02574858|P1|Participant Flow|QRH-886620|"The first three subjects will squirt via syringe into their mouths (po) 4.2 mg (2.1ml) mg of reconstituted (with 5 ml of 0.9% saline) QRH-882260 heptapeptide (~100 µM concentration). They will be asked to wait 5 minutes and then drink at least 4-8oz of tap water. The remaining seven subjects will receive (squirted via syringe into their mouths) 1mg (5ml) of reconstituted (with 5ml of 0.9% saline) QRH-882260 heptapeptide (~100 µM concentration).~QRH-882260: The investigational agent to be used in this study is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached to Cy5."
17854|NCT02574858|O1|Outcome|QRH-886620|"The first three subjects will squirt via syringe into their mouths (po) 4.2 mg (2.1ml) mg of reconstituted (with 5 ml of 0.9% saline) QRH-882260 heptapeptide (~100 µM concentration). They will be asked to wait 5 minutes and then drink at least 4-8oz of tap water. The remaining 22 subjects will receive (squirted via syringe into their mouths) 1mg (5ml) of reconstituted (with 5ml of 0.9% saline) QRH-882260 heptapeptide (~100 µM concentration).~QRH-882260: The investigational agent to be used in this study is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached to Cy5."
17870|NCT02574845|O6|Outcome|Treatment 5|The subjects received test treatment 5 which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
17963|NCT02573467|O4|Outcome|Placebo|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17855|NCT02574858|O1|Outcome|QRH-886620|"The first three subjects will squirt via syringe into their mouths (po) 4.2 mg (2.1ml) mg of reconstituted (with 5 ml of 0.9% saline) QRH-882260 heptapeptide (~100 µM concentration). They will be asked to wait 5 minutes and then drink at least 4-8oz of tap water. The remaining 22 subjects will receive (squirted via syringe into their mouths) 1mg (5ml) of reconstituted (with 5ml of 0.9% saline) QRH-882260 heptapeptide (~100 µM concentration).~QRH-882260: The investigational agent to be used in this study is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached to Cy5."
17856|NCT02574858|E1|Reported Event|QRH-886620|"The first three subjects will squirt via syringe into their mouths (po) 4.2 mg (2.1ml) mg of reconstituted (with 5 ml of 0.9% saline) QRH-882260 heptapeptide (~100 µM concentration). They will be asked to wait 5 minutes and then drink at least 4-8oz of tap water. The remaining 22 subjects will receive (squirted via syringe into their mouths) 1mg (5ml) of reconstituted (with 5ml of 0.9% saline) QRH-882260 heptapeptide (~100 µM concentration).~QRH-882260: The investigational agent to be used in this study is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached to Cy5."
17857|NCT02574845|B7|Baseline|Total|Total of all reporting groups
17858|NCT02574845|B6|Baseline|REF-T1-T2-T3-T4-T5|The subjects received REF alone, followed by T1, followed by T2, followed by T3, followed by T4 and followed by T5. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
17859|NCT02574845|B5|Baseline|T5-T4-T3-T2-T1-REF|The subjects received T5, followed by T4, followed by T3, followed by T2, followed by T1 and followed by REF alone. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
17860|NCT02574845|B4|Baseline|T4-T2-T5-REF-T3-T1|The subjects received T4, followed by T2, followed by T5, followed by REF alone, followed by T3 and followed by T1. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
17861|NCT02574845|B3|Baseline|T3-T5-T1-T4-REF-T2|The subjects received T3, followed by T5, followed by T1, followed by T4, followed by REF alone and followed by T2. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
17862|NCT02574845|B2|Baseline|T2-REF-T4-T1-T5-T3|The subjects received T2, followed by REF alone, followed by T4, followed by T1, followed by T5 and followed by T3. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
17863|NCT02574845|B1|Baseline|Treatment (T) 1-T3-Reference (REF)-T5-T2-T4|The subjects received test treatment 1 (T1) which is 10 milligram (mg) metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor) followed by test treatment 3 (T3) which is 500mg metformin hydrochloride together with REF followed by REF alone followed by test treatment 5 (T5) which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with REF followed by test treatment 2 (T2) which is 50 mg of metformin hydrochloride together with REF followed by test treatment 4 (T4) which is 1mg of furosemide together with REF. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
17864|NCT02574845|P6|Participant Flow|REF-T1-T2-T3-T4-T5|The subjects received REF alone, followed by T1, followed by T2, followed by T3, followed by T4 and followed by T5. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
17865|NCT02574845|P5|Participant Flow|T5-T4-T3-T2-T1-REF|The subjects received T5, followed by T4, followed by T3, followed by T2, followed by T1 and followed by REF alone. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
17866|NCT02574845|P4|Participant Flow|T4-T2-T5-REF-T3-T1|The subjects received T4, followed by T2, followed by T5, followed by REF alone, followed by T3 and followed by T1. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
17867|NCT02574845|P3|Participant Flow|T3-T5-T1-T4-REF-T2|The subjects received T3, followed by T5, followed by T1, followed by T4, followed by REF alone and followed by T2. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
17868|NCT02574845|P2|Participant Flow|T2-REF-T4-T1-T5-T3|The subjects received T2, followed by REF alone, followed by T4, followed by T1, followed by T5 and followed by T3. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
17869|NCT02574845|P1|Participant Flow|Treatment (T) 1-T3-Reference (REF)-T5-T2-T4|The subjects received test treatment 1 (T1) which is 10 milligram (mg) metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor) followed by test treatment 3 (T3) which is 500mg metformin hydrochloride together with REF followed by REF alone followed by test treatment 5 (T5) which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with REF followed by test treatment 2 (T2) which is 50 mg of metformin hydrochloride together with REF followed by test treatment 4 (T4) which is 1mg of furosemide together with REF. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
18052|NCT02571153|E3|Reported Event|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)~Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
17871|NCT02574845|O5|Outcome|Treatment 4|The subjects received test treatment 4 which is 1 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
17872|NCT02574845|O4|Outcome|Treatment 3|The subjects received test treatment 3 which is 500 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
17873|NCT02574845|O3|Outcome|Treatment 2|The subjects received test treatment 2 which is 50 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
17874|NCT02574845|O2|Outcome|Treatment 1|The subjects received test treatment 1 which is 10 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
17875|NCT02574845|O1|Outcome|REF Alone|The subjects received the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
17876|NCT02574845|O6|Outcome|Treatment 5|The subjects received test treatment 5 which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
17877|NCT02574845|O5|Outcome|Treatment 4|The subjects received test treatment 4 which is 1 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
17878|NCT02574845|O4|Outcome|Treatment 3|The subjects received test treatment 3 which is 500 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
17879|NCT02574845|O3|Outcome|Treatment 2|The subjects received test treatment 2 which is 50 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
17880|NCT02574845|O2|Outcome|Treatment 1|The subjects received test treatment 1 which is 10 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
17881|NCT02574845|O1|Outcome|REF Alone|The subjects received the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
17882|NCT02574845|O6|Outcome|Treatment 5|The subjects received test treatment 5 which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
17883|NCT02574845|O5|Outcome|Treatment 4|The subjects received test treatment 4 which is 1 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
17884|NCT02574845|O4|Outcome|Treatment 3|The subjects received test treatment 3 which is 500 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
17885|NCT02574845|O3|Outcome|Treatment 2|The subjects received test treatment 2 which is 50 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
17886|NCT02574845|O2|Outcome|Treatment 1|The subjects received test treatment 1 which is 10 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
17887|NCT02574845|O1|Outcome|REF Alone|The subjects received the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
17888|NCT02574845|E6|Reported Event|Treatment 5|The subjects received test treatment 5 which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
17889|NCT02574845|E5|Reported Event|Treatment 4|The subjects received test treatment 4 which is 1 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
17890|NCT02574845|E4|Reported Event|Treatment 3|The subjects received test treatment 3 which is 500 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
17891|NCT02574845|E3|Reported Event|Treatment 2|The subjects received test treatment 2 which is 50 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
17892|NCT02574845|E2|Reported Event|Treatment 1|The subjects received test treatment 1 which is 10 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
18053|NCT02571153|E2|Reported Event|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)~Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
17894|NCT02574832|B1|Baseline|Spinal Lidocaine Administration|"Spinal anesthesia will be induced with isobaric 2% lidocaine and 15 μg fentanyl.~The study lidocaine dose will be determined using a 9:1 biased-coin sequential allocation method. For the first participant, the starting dose will be 32 mg of 2% isobaric lidocaine (1.6 mL). If the lidocaine dose provides an unsatisfactory anesthetic, the case will be categorized as a failure. After a failed case, the next participant will receive a lidocaine dose increased by 4 mg. If the lidocaine dose provides satisfactory anesthesia, the next participant’s lidocaine dose will determined by a biased allocation method with a 90% chance of maintaining the dose and a 10% chance of decreasing the dose by 4 mg.~Lidocaine Administration: The lidocaine dose will be determined using a 9:1 biased-coin sequential allocation method. For the first participant, the starting dose will be 32 mg of 2% isobaric lidocaine (1.6 mL). Two outcomes will be possible: satisfactory or unsatisfactory anesthesia."
17895|NCT02574832|P1|Participant Flow|Spinal Lidocaine Administration|"Spinal anesthesia will be induced with isobaric 2% lidocaine and 15 μg fentanyl.~The study lidocaine dose will be determined using a 9:1 biased-coin sequential allocation method. For the first participant, the starting dose will be 32 mg of 2% isobaric lidocaine (1.6 mL). If the lidocaine dose provides an unsatisfactory anesthetic, the case will be categorized as a failure. After a failed case, the next participant will receive a lidocaine dose increased by 4 mg. If the lidocaine dose provides satisfactory anesthesia, the next participant’s lidocaine dose will determined by a biased allocation method with a 90% chance of maintaining the dose and a 10% chance of decreasing the dose by 4 mg.~Lidocaine Administration: The lidocaine dose will be determined using a 9:1 biased-coin sequential allocation method. For the first participant, the starting dose will be 32 mg of 2% isobaric lidocaine (1.6 mL). Two outcomes will be possible: satisfactory or unsatisfactory anesthesia."
17896|NCT02574832|O1|Outcome|Spinal Lidocaine Administration|"Spinal anesthesia will be induced with isobaric 2% lidocaine and 15 μg fentanyl.~The study lidocaine dose will be determined using a 9:1 biased-coin sequential allocation method. For the first participant, the starting dose will be 32 mg of 2% isobaric lidocaine (1.6 mL). If the lidocaine dose provides an unsatisfactory anesthetic, the case will be categorized as a failure. After a failed case, the next participant will receive a lidocaine dose increased by 4 mg. If the lidocaine dose provides satisfactory anesthesia, the next participant’s lidocaine dose will determined by a biased allocation method with a 90% chance of maintaining the dose and a 10% chance of decreasing the dose by 4 mg.~Lidocaine Administration: The lidocaine dose will be determined using a 9:1 biased-coin sequential allocation method. For the first participant, the starting dose will be 32 mg of 2% isobaric lidocaine (1.6 mL). Two outcomes will be possible: satisfactory or unsatisfactory anesthesia."
17897|NCT02574832|E1|Reported Event|Spinal Lidocaine Administration|"Spinal anesthesia will be induced with isobaric 2% lidocaine and 15 μg fentanyl.~The study lidocaine dose will be determined using a 9:1 biased-coin sequential allocation method. For the first participant, the starting dose will be 32 mg of 2% isobaric lidocaine (1.6 mL). If the lidocaine dose provides an unsatisfactory anesthetic, the case will be categorized as a failure. After a failed case, the next participant will receive a lidocaine dose increased by 4 mg. If the lidocaine dose provides satisfactory anesthesia, the next participant’s lidocaine dose will determined by a biased allocation method with a 90% chance of maintaining the dose and a 10% chance of decreasing the dose by 4 mg.~Lidocaine Administration: The lidocaine dose will be determined using a 9:1 biased-coin sequential allocation method. For the first participant, the starting dose will be 32 mg of 2% isobaric lidocaine (1.6 mL). Two outcomes will be possible: satisfactory or unsatisfactory anesthesia."
17898|NCT02574260|B1|Baseline|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ PFU/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
17899|NCT02574260|P1|Participant Flow|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ plaque forming units (PFU)/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
17900|NCT02574260|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ PFU/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
17901|NCT02574260|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ PFU/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
17902|NCT02574260|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ PFU/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
17903|NCT02574260|E1|Reported Event|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ PFU/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
17904|NCT02574247|B4|Baseline|Total|Total of all reporting groups
17905|NCT02574247|B3|Baseline|Speech Group|Participants in the Speech Group will undergo 1 visit. Medial olivocochlear reflex function and speech perception abilities will be measured at this visit to establish the correlation between these measures in the absence of any training.
17906|NCT02574247|B2|Baseline|Control|Participants in the Control arm will undergo the same number of visits as the Training arm, but will not participate in computerized auditory training. Medial olivocochlear reflex function and speech perception abilities will be measured at each visit to establish the test-retest reliability of these measurements in the absence of any training.
17907|NCT02574247|B1|Baseline|Training|"Participants in the Training arm will undergo 15 hours of computerized auditory training across 10 laboratory visits. Medial olivocochlear reflex function and speech perception abilities will be measured before, during, and after the training visits to examine the changes in the measurements across time.~Computerized auditory training: 10 sessions of computerized auditory training (1.5 hr/session) for up to 1 year."
17908|NCT02574247|P3|Participant Flow|Speech Group|Participants in the Speech Group will undergo 1 visit. Medial olivocochlear reflex function and speech perception abilities will be measured at this visit to establish the correlation between these measures in the absence of any training.
18054|NCT02571153|E1|Reported Event|Saline Group|"Normal saline 0.9% (5 mL)~Normal saline: Intravenous normal saline 0.9% 5 mL"
18055|NCT02570425|B3|Baseline|Total|Total of all reporting groups
17909|NCT02574247|P2|Participant Flow|Control|Participants in the Control arm will undergo the same number of visits as the Training arm, but will not participate in computerized auditory training. Medial olivocochlear reflex function and speech perception abilities will be measured at each visit to establish the test-retest reliability of these measurements in the absence of any training.
17910|NCT02574247|P1|Participant Flow|Training|"Participants in the Training arm will undergo 15 hours of computerized auditory training across 10 laboratory visits. Medial olivocochlear reflex function and speech perception abilities will be measured before, during, and after the training visits to examine the changes in the measurements across time.~Computerized auditory training: 10 sessions of computerized auditory training (1.5 hr/session) for up to 1 year."
17911|NCT02574247|O1|Outcome|Pooled Participant Data|Baseline data from Training, Control, and Speech Groups pooled together.
17912|NCT02574247|O1|Outcome|Training|"Participants in the Training arm will undergo 15 hours of computerized auditory training across 10 laboratory visits. Medial olivocochlear reflex function and speech perception abilities will be measured before, during, and after the training visits to examine the changes in the measurements across time.~Computerized auditory training: 10 sessions of computerized auditory training (1.5 hr/session) up to 1 year."
17913|NCT02574247|O1|Outcome|Training|"Participants in the Training arm will undergo 15 hours of computerized auditory training across 10 laboratory visits. Medial olivocochlear reflex function and speech perception abilities will be measured before, during, and after the training visits to examine the changes in the measurements across time.~Computerized auditory training: 10 sessions of computerized auditory training (1.5 hr/session) up to 1 year."
17914|NCT02574247|O1|Outcome|Pooled Participant Data|Baseline data from Training, Control, and Speech Groups pooled together.
17915|NCT02574247|O3|Outcome|Speech Group|Participants in the Speech Group will undergo 1 visit. Medial olivocochlear reflex function and speech perception abilities will be measured at this visit to establish the correlation between these measures in the absence of any training.
17916|NCT02574247|O2|Outcome|Control|Participants in the Control arm will undergo the same number of visits as the Training arm, but will not participate in computerized auditory training. Medial olivocochlear reflex function and speech perception abilities will be measured at each visit to establish the test-retest reliability of these measurements in the absence of any training.
17917|NCT02574247|O1|Outcome|Training|"Participants in the Training arm will undergo 15 hours of computerized auditory training across 10 laboratory visits. Medial olivocochlear reflex function and speech perception abilities will be measured before, during, and after the training visits to examine the changes in the measurements across time.~Computerized auditory training: 10 sessions of computerized auditory training (1.5 hr/session) for up to 1 year."
17918|NCT02574247|E3|Reported Event|Speech Group|Participants in the Speech Group will undergo 1 visit. Medial olivocochlear reflex function and speech perception abilities will be measured at this visit to establish the correlation between these measures in the absence of any training.
17919|NCT02574247|E2|Reported Event|Control|Participants in the Control arm will undergo the same number of visits as the Training arm, but will not participate in computerized auditory training. Medial olivocochlear reflex function and speech perception abilities will be measured at each visit to establish the test-retest reliability of these measurements in the absence of any training.
17920|NCT02574247|E1|Reported Event|Training|"Participants in the Training arm will undergo 15 hours of computerized auditory training across 10 laboratory visits. Medial olivocochlear reflex function and speech perception abilities will be measured before, during, and after the training visits to examine the changes in the measurements across time.~Computerized auditory training: 10 sessions of computerized auditory training (1.5 hr/session) for up to 1 year."
17921|NCT02573870|B3|Baseline|Total|Total of all reporting groups
17922|NCT02573870|B2|Baseline|BAT/FF 300/100 µg|Participants received oral inhalation of BAT/FF 300/100 µg via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
17923|NCT02573870|B1|Baseline|Placebo|Participants received oral inhalation of placebo via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
17924|NCT02573870|P2|Participant Flow|BAT/FF 300/100 µg|Participants received oral inhalation of BAT/FF 300/100 µg via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed,while receiving investigational product.
17925|NCT02573870|P1|Participant Flow|Placebo|Participants received oral inhalation of placebo via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
17926|NCT02573870|O2|Outcome|BAT/FF 300/100 µg|Participants received oral inhalation of BAT/FF 300/100 µg via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
17927|NCT02573870|O1|Outcome|Placebo|Participants received oral inhalation of placebo via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
17928|NCT02573870|E2|Reported Event|BAT/FF 300/100 µg|Participants received oral inhalation of BAT/FF 300/100 µg via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
17929|NCT02573870|E1|Reported Event|Placebo|Participants received oral inhalation of placebo via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
17930|NCT02573467|B5|Baseline|Total|Total of all reporting groups
17931|NCT02573467|B4|Baseline|Placebo|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17932|NCT02573467|B3|Baseline|BYM338/Bimagrumab 1 mg/kg|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17934|NCT02573467|B1|Baseline|BYM338/Bimagrumab 10 mg/kg|Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17935|NCT02573467|P4|Participant Flow|Placebo|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17936|NCT02573467|P3|Participant Flow|BYM338/Bimagrumab 1 mg/kg|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17937|NCT02573467|P2|Participant Flow|BYM338/Bimagrumab 3 mg/kg|Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..
17938|NCT02573467|P1|Participant Flow|BYM338/Bimagrumab 10 mg/kg|Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17939|NCT02573467|O4|Outcome|Placebo|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17940|NCT02573467|O3|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17941|NCT02573467|O2|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..
17942|NCT02573467|O1|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17943|NCT02573467|O4|Outcome|Placebo|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17944|NCT02573467|O3|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17945|NCT02573467|O2|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..
17946|NCT02573467|O1|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17947|NCT02573467|O4|Outcome|Placebo|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17948|NCT02573467|O3|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17949|NCT02573467|O2|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..
17950|NCT02573467|O1|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17951|NCT02573467|O4|Outcome|Placebo|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17952|NCT02573467|O3|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17953|NCT02573467|O2|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..
17954|NCT02573467|O1|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17955|NCT02573467|O4|Outcome|Placebo|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17956|NCT02573467|O3|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17957|NCT02573467|O2|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..
17958|NCT02573467|O1|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17959|NCT02573467|O4|Outcome|Placebo|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17960|NCT02573467|O3|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17961|NCT02573467|O2|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..
17962|NCT02573467|O1|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17964|NCT02573467|O3|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17965|NCT02573467|O2|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..
17966|NCT02573467|O1|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17967|NCT02573467|O4|Outcome|Placebo|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17968|NCT02573467|O3|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17969|NCT02573467|O2|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..
17970|NCT02573467|O1|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17971|NCT02573467|E5|Reported Event|Pooled Active Treatment Groups|Participants from all 3 BYM338 groups
17972|NCT02573467|E4|Reported Event|Placebo|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17973|NCT02573467|E3|Reported Event|BYM338/Bimagrumab 1 mg/kg|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17974|NCT02573467|E2|Reported Event|BYM338/Bimagrumab 3 mg/kg|Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..
17975|NCT02573467|E1|Reported Event|BYM338/Bimagrumab 10 mg/kg|Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
17976|NCT02572752|B4|Baseline|Total|Total of all reporting groups
17977|NCT02572752|B3|Baseline|Nin 1x200 mg(T) / Nin 2x100 mg(R1) / Nin 2x100 mg(R2)|Subjects were treated with single oral dose, started in Period 1 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water, followed in Period 2 (Reference treatment (R1)) and Period 3 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100 mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
17978|NCT02572752|B2|Baseline|Nin 2x100 mg(R1) / Nin 1x200 mg(T) / Nin 2x100 mg(R2)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water, followed in Period 2 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water and in Period 3 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
17979|NCT02572752|B1|Baseline|Nin 2x100 mg(R1) / Nin 2x100 mg(R2) / Nin 1x200 mg(T)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) and Period 2 (Reference treatment (R2)) with nintedanib (nin) soft gelatine capsule, 200 mg (2x100 mg) with about 240 mL of water, followed in Period 3 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
17980|NCT02572752|P3|Participant Flow|Nin 1x200 mg(T) / Nin 2x100 mg(R1) / Nin 2x100 mg(R2)|Subjects were treated with single oral dose, started in Period 1 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water, followed in Period 2 (Reference treatment (R1)) and Period 3 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100 mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
17981|NCT02572752|P2|Participant Flow|Nin 2x100 mg(R1) / Nin 1x200 mg(T) / Nin 2x100 mg(R2)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water, followed in Period 2 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water and in Period 3 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
17982|NCT02572752|P1|Participant Flow|Nin 2x100 mg(R1) / Nin 2x100 mg(R2) / Nin 1x200 mg(T)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) and Period 2 (Reference treatment (R2)) with nintedanib (nin) soft gelatine capsule, 200 mg (2x100 mg) with about 240 mL of water, followed in Period 3 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
17983|NCT02572752|O3|Outcome|Nintedanib, Reference Treatment (R2)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water.
17984|NCT02572752|O2|Outcome|Nintedanib, Reference Treatment (R1)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water.
17985|NCT02572752|O1|Outcome|Nintedanib, Test Treatment (T)|Subjects were treated with single oral dose, started in Period 1 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water.
17986|NCT02572752|O3|Outcome|Nintedanib, Reference Treatment (R2)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water.
17987|NCT02572752|O2|Outcome|Nintedanib, Reference Treatment (R1)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water.
17988|NCT02572752|O1|Outcome|Nintedanib, Test Treatment (T)|Subjects were treated with single oral dose, started in Period 1 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water.
17989|NCT02572752|O3|Outcome|Nintedanib, Reference Treatment (R2)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water.
17990|NCT02572752|O2|Outcome|Nintedanib, Reference Treatment (R1)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water.
17991|NCT02572752|O1|Outcome|Nintedanib, Test Treatment (T)|Subjects were treated with single oral dose, started in Period 1 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water.
17992|NCT02572752|E2|Reported Event|Nintedanib, Reference Treatment (R1 & R2)|Subjects were treated twice with single oral dose of nintedanib soft gelatine capsule (Reference treatment (R1 & R2)), 200 mg (2x100mg) with about 240 mL of water.
17993|NCT02572752|E1|Reported Event|Nintedanib, Test Treatment (T)|Subjects were treated with single oral dose of nintedanib soft gelatine capsule (Test treatment (T)) , 200 mg (1x200mg) with about 240 mL of water.
17994|NCT02572609|B3|Baseline|Total|Total of all reporting groups
17995|NCT02572609|B2|Baseline|Sequence: RT|"2.5 mL, single dose, of Mucosolvan ® adult syrup (Reference product) in period 1 and 01 pastille, single dose, of Ambroxol hydrochloride soft pastille 15 mg (Test product) in period 2.~Washout period: 7 days"
17996|NCT02572609|B1|Baseline|Sequence: TR|"01 pastille, single dose of Ambroxol hydrochloride soft pastille 15 mg (Test product) in period 1 and 2.5 mL, single dose, of Mucosolvan ® adult syrup (Reference product) in period 2.~Washout period: 7 days"
17997|NCT02572609|P2|Participant Flow|Sequence: RT|"2.5 mL, single dose, of Mucosolvan ® adult syrup (Reference product) in period 1 and 01 pastille, single dose, of Ambroxol hydrochloride soft pastille 15 mg (Test product) in period 2.~Washout period: 7 days"
17998|NCT02572609|P1|Participant Flow|Sequence: TR|"01 pastille, single dose of Ambroxol hydrochloride soft pastille 15 mg (Test product) in period 1 and 2.5 mL, single dose, of Mucosolvan ® adult syrup (Reference product) in period 2.~Washout period: 7 days"
17999|NCT02572609|O2|Outcome|Ambroxol Hydrochloride Soft Pastille|01 pastille, single dose of Ambroxol hydrochloride soft pastille 15 mg (Test product).
18000|NCT02572609|O1|Outcome|Mucosolvan ® Adult Syrup|2.5 mL, single dose, of Mucosolvan ® adult syrup 6 mg/mL (Reference product).
18001|NCT02572609|O2|Outcome|Ambroxol Hydrochloride Soft Pastille|01 pastille, single dose of Ambroxol hydrochloride soft pastille 15 mg (Test product).
18002|NCT02572609|O1|Outcome|Mucosolvan ® Adult Syrup|2.5 mL, single dose, of Mucosolvan ® adult syrup 6 mg/mL (Reference product).
18003|NCT02572609|E2|Reported Event|Ambroxol Hydrochloride Soft Pastille|
18004|NCT02572609|E1|Reported Event|Mucosolvan® Adult Syrup|
18005|NCT02572427|B3|Baseline|Total|Total of all reporting groups
18006|NCT02572427|B2|Baseline|No Added Education for Intubation Skills|"Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.~No added education for intubation skills: Routine training in neonatal resuscitation but no added experience in simulation lab."
18007|NCT02572427|B1|Baseline|Education for Intubation Skills|"Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.~Education for intubation skills: Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab."
18008|NCT02572427|P2|Participant Flow|No Added Education for Intubation Skills|"Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.~No added education for intubation skills: Routine training in neonatal resuscitation but no added experience in simulation lab."
18009|NCT02572427|P1|Participant Flow|Education for Intubation Skills|"Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.~Education for intubation skills: Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab."
18010|NCT02572427|O2|Outcome|No Added Education for Intubation Skills|"Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.~No added education for intubation skills: Routine training in neonatal resuscitation but no added experience in simulation lab."
18011|NCT02572427|O1|Outcome|Education for Intubation Skills|"Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.~Education for intubation skills: Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab."
18012|NCT02572427|O2|Outcome|No Added Education for Intubation Skills|"Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.~No added education for intubation skills: Routine training in neonatal resuscitation but no added experience in simulation lab."
18013|NCT02572427|O1|Outcome|Education for Intubation Skills|"Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.~Education for intubation skills: Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab."
18258|NCT02569658|O2|Outcome|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision~Placebo"
18014|NCT02572427|E2|Reported Event|No Added Education for Intubation Skills|"Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.~No added education for intubation skills: Routine training in neonatal resuscitation but no added experience in simulation lab."
18015|NCT02572427|E1|Reported Event|Education for Intubation Skills|"Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.~Education for intubation skills: Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab."
18016|NCT02571634|B1|Baseline|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control."
18017|NCT02571634|P1|Participant Flow|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control."
18018|NCT02571634|O1|Outcome|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control."
18019|NCT02571634|O1|Outcome|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.~There were no adverse events."
18020|NCT02571634|O1|Outcome|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.~There were no adverse events."
18021|NCT02571634|O1|Outcome|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.~There were no adverse events."
18022|NCT02571634|O1|Outcome|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.~There were no adverse events."
18023|NCT02571634|E1|Reported Event|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.~There were no adverse events."
18024|NCT02571153|B4|Baseline|Total|Total of all reporting groups
18025|NCT02571153|B3|Baseline|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)~Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
18026|NCT02571153|B2|Baseline|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)~Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
18027|NCT02571153|B1|Baseline|Saline Group|"Normal saline 0.9% (5 mL)~Normal saline: Intravenous normal saline 0.9% 5 mL"
18028|NCT02571153|P3|Participant Flow|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)~Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
18029|NCT02571153|P2|Participant Flow|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)~Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
18030|NCT02571153|P1|Participant Flow|Saline Group|"Normal saline 0.9% (5 mL)~Normal saline: Intravenous normal saline 0.9% 5 mL"
18031|NCT02571153|O3|Outcome|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)~Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
18032|NCT02571153|O2|Outcome|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)~Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
18033|NCT02571153|O1|Outcome|Saline Group|"Normal saline 0.9% (5 mL)~Normal saline: Intravenous normal saline 0.9% 5 mL"
18034|NCT02571153|O3|Outcome|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)~Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
18035|NCT02571153|O2|Outcome|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)~Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
18036|NCT02571153|O1|Outcome|Saline Group|"Normal saline 0.9% (5 mL)~Normal saline: Intravenous normal saline 0.9% 5 mL"
18037|NCT02571153|O3|Outcome|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)~Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
18038|NCT02571153|O2|Outcome|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)~Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
18039|NCT02571153|O1|Outcome|Saline Group|"Normal saline 0.9% (5 mL)~Normal saline: Intravenous normal saline 0.9% 5 mL"
18040|NCT02571153|O3|Outcome|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)~Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
18041|NCT02571153|O2|Outcome|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)~Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
18042|NCT02571153|O1|Outcome|Saline Group|"Normal saline 0.9% (5 mL)~Normal saline: Intravenous normal saline 0.9% 5 mL"
18043|NCT02571153|O3|Outcome|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)~Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
18044|NCT02571153|O2|Outcome|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)~Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
18045|NCT02571153|O1|Outcome|Saline Group|"Normal saline 0.9% (5 mL)~Normal saline: Intravenous normal saline 0.9% 5 mL"
18046|NCT02571153|O3|Outcome|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)~Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
18047|NCT02571153|O2|Outcome|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)~Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
18048|NCT02571153|O1|Outcome|Saline Group|"Normal saline 0.9% (5 mL)~Normal saline: Intravenous normal saline 0.9% 5 mL"
18049|NCT02571153|O3|Outcome|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)~Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
18050|NCT02571153|O2|Outcome|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)~Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
18051|NCT02571153|O1|Outcome|Saline Group|"Normal saline 0.9% (5 mL)~Normal saline: Intravenous normal saline 0.9% 5 mL"
18056|NCT02570425|B2|Baseline|Budesonide/Formoterol (BF) Spiromax® First, Then Turbohaler®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
18057|NCT02570425|B1|Baseline|SYMBICORT Turbohaler® First, Then Spiromax®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
18058|NCT02570425|P2|Participant Flow|Placebo Comparator: Turbohaler Followed by Spiromax|Training on SYMBICORT Turbohaler followed by BF Spiromax
18059|NCT02570425|P1|Participant Flow|Placebo Comparator: Spiromax Followed by Turbohaler|Training on BF Spiromax followed by SYMBICORT Turbohaler
18060|NCT02570425|O3|Outcome|No Preference|"HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
18061|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
18062|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
18063|NCT02570425|O3|Outcome|No Preference|"HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
18064|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
18119|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
18120|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
18356|NCT02567552|B1|Baseline|Prolutex|"Subcutaneous progesterone~Subcutaneous progesterone: subcutaneous progesterone 25 mg/day"
18065|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
18066|NCT02570425|O3|Outcome|No Preference|"HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
18067|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
18068|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
18069|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
18070|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
18071|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
18072|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
18121|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
28120|NCT02468414|B2|Baseline|Group B|TARGTEPO 35-45 IU/kg/day
18073|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
18074|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
18075|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
18076|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
18077|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
18078|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
18079|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
18122|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
18123|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
18124|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
28121|NCT02468414|B1|Baseline|Group A|TARGTEPO 18-25 IU/kg/day
18080|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
18081|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
18082|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
18083|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
18084|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
18085|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
18086|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
18125|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
18126|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
18259|NCT02569658|O1|Outcome|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.~Tranexamic Acid"
18087|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
18088|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
18089|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
18090|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
18091|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
18092|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
18093|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
18127|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
18354|NCT02567552|B3|Baseline|Total|Total of all reporting groups
18094|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
18095|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
18096|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
18097|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
18098|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
18099|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
18100|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
18128|NCT02570295|E2|Reported Event|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
18154|NCT02570165|O5|Outcome|Batefenterol 300 µg|Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
18101|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
18102|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
18103|NCT02570425|E2|Reported Event|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
18104|NCT02570425|E1|Reported Event|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
18105|NCT02570295|B3|Baseline|Total|Total of all reporting groups
18106|NCT02570295|B2|Baseline|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
18107|NCT02570295|B1|Baseline|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
18108|NCT02570295|P2|Participant Flow|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
18109|NCT02570295|P1|Participant Flow|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
18110|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
18111|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
18112|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
18113|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
18114|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
18115|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
18116|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
18117|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
18118|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
18213|NCT02569996|E1|Reported Event|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
18214|NCT02569957|B3|Baseline|Total|Total of all reporting groups
18129|NCT02570295|E1|Reported Event|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
18130|NCT02570165|B8|Baseline|Total|Total of all reporting groups
18131|NCT02570165|B7|Baseline|UMEC/VI 62.5/25 µg|Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
18132|NCT02570165|B6|Baseline|Batefenterol 600 µg|Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
18133|NCT02570165|B5|Baseline|Batefenterol 300 µg|Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
18134|NCT02570165|B4|Baseline|Batefenterol 150 µg|Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
18135|NCT02570165|B3|Baseline|Batefenterol 75 µg|Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
18136|NCT02570165|B2|Baseline|Batefenterol 37.5 µg|Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
18137|NCT02570165|B1|Baseline|Placebo|Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
18138|NCT02570165|P7|Participant Flow|UMEC/VI 62.5/25 µg|Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
18139|NCT02570165|P6|Participant Flow|Batefenterol 600 µg|Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
18140|NCT02570165|P5|Participant Flow|Batefenterol 300 µg|Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
18141|NCT02570165|P4|Participant Flow|Batefenterol 150 µg|Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
18142|NCT02570165|P3|Participant Flow|Batefenterol 75 µg|Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
18143|NCT02570165|P2|Participant Flow|Batefenterol 37.5 µg|Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
18144|NCT02570165|P1|Participant Flow|Placebo|Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
18145|NCT02570165|O7|Outcome|UMEC/VI 62.5/25 µg|Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
18146|NCT02570165|O6|Outcome|Batefenterol 600 µg|Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
18147|NCT02570165|O5|Outcome|Batefenterol 300 µg|Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
18148|NCT02570165|O4|Outcome|Batefenterol 150 µg|Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
18149|NCT02570165|O3|Outcome|Batefenterol 75 µg|Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
18150|NCT02570165|O2|Outcome|Batefenterol 37.5 µg|Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
18151|NCT02570165|O1|Outcome|Placebo|Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
18152|NCT02570165|O7|Outcome|UMEC/VI 62.5/25 µg|Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
18153|NCT02570165|O6|Outcome|Batefenterol 600 µg|Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
18155|NCT02570165|O4|Outcome|Batefenterol 150 µg|Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
18156|NCT02570165|O3|Outcome|Batefenterol 75 µg|Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
18157|NCT02570165|O2|Outcome|Batefenterol 37.5 µg|Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
18158|NCT02570165|O1|Outcome|Placebo|Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
18159|NCT02570165|E7|Reported Event|UMEC/VI 62.5/25 µg|Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
18160|NCT02570165|E6|Reported Event|Batefenterol 600 µg|Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
18161|NCT02570165|E5|Reported Event|Batefenterol 300 µg|Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
18162|NCT02570165|E4|Reported Event|Batefenterol 150 µg|Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
18163|NCT02570165|E3|Reported Event|Batefenterol 75 µg|Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained btefenterol blended with lactose.
18164|NCT02570165|E2|Reported Event|Batefenterol 37.5 µg|Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
18165|NCT02570165|E1|Reported Event|Placebo|Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
18166|NCT02570126|B3|Baseline|Total|Total of all reporting groups
18167|NCT02570126|B2|Baseline|VAR Group|2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
18168|NCT02570126|B1|Baseline|VAR_HSA_F Group|2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
18169|NCT02570126|P2|Participant Flow|VAR Group|2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
18170|NCT02570126|P1|Participant Flow|VAR_HSA_F Group|2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
18171|NCT02570126|O2|Outcome|VAR Group|2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
18172|NCT02570126|O1|Outcome|VAR_HSA_F Group|2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
18173|NCT02570126|O2|Outcome|VAR Group|2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
18174|NCT02570126|O1|Outcome|VAR_HSA_F Group|2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
18175|NCT02570126|O2|Outcome|VAR Group|2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
18176|NCT02570126|O1|Outcome|VAR_HSA_F Group|2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
18177|NCT02570126|O2|Outcome|VAR Group|2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
18178|NCT02570126|O1|Outcome|VAR_HSA_F Group|2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
18179|NCT02570126|O2|Outcome|VAR Group|2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
18180|NCT02570126|O1|Outcome|VAR_HSA_F Group|2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
18181|NCT02570126|O2|Outcome|VAR Group|2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
18182|NCT02570126|O1|Outcome|VAR_HSA_F Group|2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
18183|NCT02570126|O2|Outcome|VAR Group|2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
18184|NCT02570126|O1|Outcome|VAR_HSA_F Group|2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
18185|NCT02570126|O2|Outcome|VAR Group|2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
18186|NCT02570126|O1|Outcome|VAR_HSA_F Group|2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
18187|NCT02570126|O2|Outcome|VAR Group|2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
18188|NCT02570126|O1|Outcome|VAR_HSA_F Group|2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
18189|NCT02570126|O2|Outcome|VAR Group|2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
18190|NCT02570126|O1|Outcome|VAR_HSA_F Group|2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
18191|NCT02570126|E2|Reported Event|VAR Group|2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
18192|NCT02570126|E1|Reported Event|VAR_HSA_F Group|2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
18193|NCT02570022|B3|Baseline|Total|Total of all reporting groups
18194|NCT02570022|B2|Baseline|Inter-scalene Nerve Block|"Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.~Inter-scalene nerve block: Pre-operative inter-scalene nerve block~Ropivacaine: Ropivicaine was used for the inter-scalene nerve block."
18195|NCT02570022|B1|Baseline|Liposomal Bupivacaine|"Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.~Liposomal bupivacaine: Local infiltration of liposomal bupivacaine"
18196|NCT02570022|P2|Participant Flow|Inter-scalene Nerve Block|"Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.~Inter-scalene nerve block: Pre-operative inter-scalene nerve block~Ropivacaine: Ropivicaine was used for the inter-scalene nerve block."
18197|NCT02570022|P1|Participant Flow|Liposomal Bupivacaine|"Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.~Liposomal bupivacaine: Local infiltration of liposomal bupivacaine"
18198|NCT02570022|O2|Outcome|Inter-scalene Nerve Block|"Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.~Inter-scalene nerve block: Pre-operative inter-scalene nerve block~Ropivacaine: Ropivicaine was used for the inter-scalene nerve block."
18199|NCT02570022|O1|Outcome|Liposomal Bupivacaine|"Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.~Liposomal bupivacaine: Local infiltration of liposomal bupivacaine"
18200|NCT02570022|O2|Outcome|Inter-scalene Nerve Block|"Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.~Inter-scalene nerve block: Pre-operative inter-scalene nerve block~Ropivacaine: Ropivicaine was used for the inter-scalene nerve block."
18201|NCT02570022|O1|Outcome|Liposomal Bupivacaine|"Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.~Liposomal bupivacaine: Local infiltration of liposomal bupivacaine"
18202|NCT02570022|E2|Reported Event|Inter-scalene Nerve Block|"Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.~Inter-scalene nerve block: Pre-operative inter-scalene nerve block~Ropivacaine: Ropivicaine was used for the inter-scalene nerve block."
18203|NCT02570022|E1|Reported Event|Liposomal Bupivacaine|"Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.~Liposomal bupivacaine: Local infiltration of liposomal bupivacaine"
18204|NCT02569996|B1|Baseline|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
18205|NCT02569996|P1|Participant Flow|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
18206|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
18207|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
18208|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
18209|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
18210|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
18211|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
18212|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
28122|NCT02468414|P2|Participant Flow|Group B|35-45 IU/Kg/day
18215|NCT02569957|B2|Baseline|Arm II (Topotecan Hydrochloride, Acetylcysteine)|"Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV~Acetylcysteine: Given IV and PO"
18216|NCT02569957|B1|Baseline|Arm I (Topotecan Hydrochloride)|"Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV"
18217|NCT02569957|P2|Participant Flow|Arm II (Topotecan Hydrochloride, Acetylcysteine)|"Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV~Acetylcysteine: Given IV and PO"
18218|NCT02569957|P1|Participant Flow|Arm I (Topotecan Hydrochloride)|"Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV"
18219|NCT02569957|O2|Outcome|Arm II (Topotecan Hydrochloride, Acetylcysteine)|"Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV~Acetylcysteine: Given IV and PO"
18220|NCT02569957|O1|Outcome|Arm I (Topotecan Hydrochloride)|"Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV"
18221|NCT02569957|O2|Outcome|Arm II (Topotecan Hydrochloride, Acetylcysteine)|"Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV~Acetylcysteine: Given IV and PO"
18222|NCT02569957|O1|Outcome|Arm I (Topotecan Hydrochloride)|"Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV"
18223|NCT02569957|O2|Outcome|Arm II (Topotecan Hydrochloride, Acetylcysteine)|"Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV~Acetylcysteine: Given IV and PO"
18224|NCT02569957|O1|Outcome|Arm I (Topotecan Hydrochloride)|"Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV"
18225|NCT02569957|O2|Outcome|Arm II (Topotecan Hydrochloride, Acetylcysteine)|"Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV~Acetylcysteine: Given IV and PO"
18226|NCT02569957|O1|Outcome|Arm I (Topotecan Hydrochloride)|"Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV"
18227|NCT02569957|O2|Outcome|Arm II (Topotecan Hydrochloride, Acetylcysteine)|"Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV~Acetylcysteine: Given IV and PO"
18228|NCT02569957|O1|Outcome|Arm I (Topotecan Hydrochloride)|"Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV"
18229|NCT02569957|O2|Outcome|Arm II (Topotecan Hydrochloride, Acetylcysteine)|"Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV~Acetylcysteine: Given IV and PO"
18230|NCT02569957|O1|Outcome|Arm I (Topotecan Hydrochloride)|"Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV"
18231|NCT02569957|O2|Outcome|Arm II (Topotecan Hydrochloride, Acetylcysteine)|"Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV~Acetylcysteine: Given IV and PO"
18232|NCT02569957|O1|Outcome|Arm I (Topotecan Hydrochloride)|"Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV"
18233|NCT02569957|O2|Outcome|Arm II (Topotecan Hydrochloride, Acetylcysteine)|"Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV~Acetylcysteine: Given IV and PO"
18234|NCT02569957|O1|Outcome|Arm I (Topotecan Hydrochloride)|"Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV"
18235|NCT02569957|O2|Outcome|Arm II (Topotecan Hydrochloride, Acetylcysteine)|"Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV~Acetylcysteine: Given IV and PO"
18236|NCT02569957|O1|Outcome|Arm I (Topotecan Hydrochloride)|"Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV"
18237|NCT02569957|O2|Outcome|Arm II (Topotecan Hydrochloride, Acetylcysteine)|"Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV~Acetylcysteine: Given IV and PO"
18238|NCT02569957|O1|Outcome|Arm I (Topotecan Hydrochloride)|"Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV"
18239|NCT02569957|O2|Outcome|Arm II (Topotecan Hydrochloride, Acetylcysteine)|"Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV~Acetylcysteine: Given IV and PO"
18240|NCT02569957|O1|Outcome|Arm I (Topotecan Hydrochloride)|"Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV"
18241|NCT02569957|O2|Outcome|Arm II (Topotecan Hydrochloride, Acetylcysteine)|"Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV~Acetylcysteine: Given IV and PO"
18242|NCT02569957|O1|Outcome|Arm I (Topotecan Hydrochloride)|"Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV"
18243|NCT02569957|O2|Outcome|Arm II (Topotecan Hydrochloride, Acetylcysteine)|"Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV~Acetylcysteine: Given IV and PO"
18244|NCT02569957|O1|Outcome|Arm I (Topotecan Hydrochloride)|"Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV"
18245|NCT02569957|E2|Reported Event|Arm II (Topotecan Hydrochloride, Acetylcysteine)|"Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV~Acetylcysteine: Given IV and PO"
18246|NCT02569957|E1|Reported Event|Arm I (Topotecan Hydrochloride)|"Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Topotecan Hydrochloride: Given IV"
18247|NCT02569658|B3|Baseline|Total|Total of all reporting groups
18248|NCT02569658|B2|Baseline|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision~Placebo"
18249|NCT02569658|B1|Baseline|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.~Tranexamic Acid"
18250|NCT02569658|P2|Participant Flow|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision~Placebo"
18251|NCT02569658|P1|Participant Flow|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.~Tranexamic Acid"
18252|NCT02569658|O2|Outcome|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision~Placebo"
18253|NCT02569658|O1|Outcome|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.~Tranexamic Acid"
18254|NCT02569658|O2|Outcome|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision~Placebo"
18255|NCT02569658|O1|Outcome|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.~Tranexamic Acid"
18256|NCT02569658|O2|Outcome|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision~Placebo"
18260|NCT02569658|O2|Outcome|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision~Placebo"
18261|NCT02569658|O1|Outcome|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.~Tranexamic Acid"
18262|NCT02569658|O2|Outcome|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision~Placebo"
18263|NCT02569658|O1|Outcome|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.~Tranexamic Acid"
18264|NCT02569658|E2|Reported Event|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision~Placebo"
18265|NCT02569658|E1|Reported Event|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.~Tranexamic Acid"
18266|NCT02569437|B3|Baseline|Total|Total of all reporting groups
18267|NCT02569437|B2|Baseline|Sugar Pill|placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.
18268|NCT02569437|B1|Baseline|Doxycycline|Doxycycline plus oral methylprednisolone and nasal saline sprays
18269|NCT02569437|P2|Participant Flow|Sugar Pill|"placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.~methylprednisolone: oral methylprednisolone: 32 mg x 5 days, 16 mg x 5 days, 8 mg x 10 days~Flonase: daily nasal steroid sprays (Flonase, 2 sprays each nostril daily).~sugar pill: placebo pill to match doxycycline"
18270|NCT02569437|P1|Participant Flow|Doxycycline|"Doxycycline plus oral methylprednisolone and nasal saline sprays~Doxycycline: Doxycycline (200 mg PO X 1 dose on Day 1, then 100 mg PO daily) for Day 2-20~methylprednisolone: oral methylprednisolone: 32 mg x 5 days, 16 mg x 5 days, 8 mg x 10 days~nasal saline spray: nasal saline sprays: 2 sprays each nostril three times a day~Flonase: daily nasal steroid sprays (Flonase, 2 sprays each nostril daily)."
18271|NCT02569437|O2|Outcome|Sugar Pill|placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.
18272|NCT02569437|O1|Outcome|Doxycycline|Doxycycline plus oral methylprednisolone and nasal saline sprays
18273|NCT02569437|O2|Outcome|Sugar Pill|placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.
18274|NCT02569437|O1|Outcome|Doxycycline|Doxycycline plus oral methylprednisolone and nasal saline sprays
18275|NCT02569437|O2|Outcome|Sugar Pill|placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.
18276|NCT02569437|O1|Outcome|Doxycycline|Doxycycline plus oral methylprednisolone and nasal saline sprays
18277|NCT02569437|O2|Outcome|Sugar Pill|placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.
18278|NCT02569437|O1|Outcome|Doxycycline|Doxycycline plus oral methylprednisolone and nasal saline sprays
18279|NCT02569437|O2|Outcome|Sugar Pill|placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.
18280|NCT02569437|O1|Outcome|Doxycycline|Doxycycline plus oral methylprednisolone and nasal saline sprays
18281|NCT02569437|E2|Reported Event|Sugar Pill|placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.
18282|NCT02569437|E1|Reported Event|Doxycycline|Doxycycline plus oral methylprednisolone and nasal saline sprays
18283|NCT02569086|B1|Baseline|Piperacillin Pharmacokinetics|Patients with known or suspected sepsis or severe sepsis, treated empirically with piperacillin/tazobactam 4g/0,5g (Tazocin®) every eight hour (q8h).
18284|NCT02569086|P1|Participant Flow|Piperacillin Pharmacokinetics|Patients with known or suspected sepsis or severe sepsis, treated empirically with piperacillin/tazobactam 4g/0,5g (Tazocin®) every eight hour (q8h).
18285|NCT02569086|O1|Outcome|Piperacillin Pharmacokinetics|Patients with known or suspected sepsis or severe sepsis, treated empirically with piperacillin/tazobactam 4g/0,5g (Tazocin®) every eight hour (q8h).
18286|NCT02569086|O1|Outcome|Piperacillin Pharmacokinetics|Patients with known or suspected sepsis or severe sepsis, treated empirically with piperacillin/tazobactam 4g/0,5g (Tazocin®) every eight hour (q8h).
18287|NCT02569086|E1|Reported Event|Piperacillin Pharmacokinetics|Patients with known or suspected sepsis or severe sepsis, treated empirically with piperacillin/tazobactam 4g/0,5g (Tazocin®) every eight hour (q8h).
18288|NCT02568852|B3|Baseline|Total|Total of all reporting groups
18289|NCT02568852|B2|Baseline|Group 2|Laparoscopic cholecystectomy in under 14 mmHg pneumoperitoneum
18290|NCT02568852|B1|Baseline|Group 1|Laparoscopic cholecystectomy in under 10 mmHg pneumoperitoneum
18291|NCT02568852|P2|Participant Flow|Group 2|Laparoscopic cholecystectomy under combined anaesthesia (Spino epidural).
18292|NCT02568852|P1|Participant Flow|Group 1|Laparoscopic cholecystectomy under general anaesthesia
18293|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
18294|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
18295|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
18296|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
18297|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
18298|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
28123|NCT02468414|P1|Participant Flow|Group A|18-25 IU/Kg/day
18299|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
18300|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
18301|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
18302|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
18303|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
18304|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
18305|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
18306|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
18307|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
18308|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
18309|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
18310|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
18311|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
18312|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
18313|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
18314|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
18315|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
18316|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
18317|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
18318|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
18319|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
18320|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
18321|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
18322|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
18323|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
18324|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
18325|NCT02568852|E2|Reported Event|Group 2|Laparoscopic cholecystectomy in under spinal epidural anaesthesia.(10 mmHg CO2 pneumoperitoneum)
18326|NCT02568852|E1|Reported Event|Group 1|Laparoscopic cholecystectomy in under general anaesthesia.(10 mmHg CO2 pneumoperitoneum)
18327|NCT02568384|B1|Baseline|Users of Onyx BG Meter / App System|"Subjects with diabetes used the Onyx BG Meter / App System at home. The enrollment goal for the intended use population:~40 to 70% of subjects will have type 1 diabetes~Not more than 30% of subjects will use an insulin pump~Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions."
18328|NCT02568384|P1|Participant Flow|Users of Onyx BG Meter / App System|"Subjects with diabetes used the Onyx BG Meter / App System at home. The enrollment goal for the intended use population:~40 to 70% of subjects will have type 1 diabetes~Not more than 30% of subjects will use an insulin pump~Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions."
18329|NCT02568384|O1|Outcome|Users of Onyx BG Meter / App System|"Subjects with diabetes used the Onyx BG Meter / App System at home.~Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions."
18355|NCT02567552|B2|Baseline|Prontogest|"Intramuscular progesterone~Intramuscular progesterone: intramuscular progesterone 50 mg/day"
28124|NCT02468414|O2|Outcome|Group B|TARGTEPO 35-45 IU/kg/day
18330|NCT02568384|O1|Outcome|Users of Onyx BG Meter / App System|"Subjects with diabetes used the Onyx BG Meter / App System at home.~Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions."
18331|NCT02568384|O1|Outcome|Users of Onyx BG Meter / App System|"Subjects with diabetes used the Onyx BG Meter / App System at home.~Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions."
18332|NCT02568384|O1|Outcome|Users of Onyx BG Meter / App System|"Subjects with diabetes used the Onyx BG Meter / App System at home.~Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions."
18333|NCT02568384|O1|Outcome|Users of Onyx BG Meter / App System|"Subjects with diabetes used the Onyx BG Meter / App System at home.~Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions."
18334|NCT02568384|O1|Outcome|Users of Onyx BG Meter / App System|"Subjects with diabetes used the Onyx BG Meter / App System at home.~Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions."
18335|NCT02568384|O1|Outcome|Users of Onyx BG Meter / App System|"Subjects with diabetes used the Onyx BG Meter / App System at home.~Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions."
18336|NCT02568384|E1|Reported Event|Users of Onyx BG Meter / App System|"Subjects with diabetes used the Onyx BG Meter / App System at home. The enrollment goal for the intended use population:~40 to 70% of subjects will have type 1 diabetes~Not more than 30% of subjects will use an insulin pump~Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions."
18337|NCT02568345|B1|Baseline|Sugammadex ED90|"Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).~The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg.~sugammadex ED90: The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.~In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg."
18338|NCT02568345|P1|Participant Flow|Sugammadex ED90|"Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).~The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg.~sugammadex ED90: The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.~In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg."
18339|NCT02568345|O1|Outcome|Sugammadex ED90|"Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).~The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg.~sugammadex ED90: The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.~In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg."
18340|NCT02568345|E1|Reported Event|Sugammadex ED90|"Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).~The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg.~sugammadex ED90: The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.~In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg."
18341|NCT02568254|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least 1 study lens.
18342|NCT02568254|P6|Participant Flow|Nesofilcon A/ Nelfilcon A/Etafilcon A|All subjects that were randomized to receive the nesofilcon A lens first, the nelfilcon A lens second and the etafilcon A lens third.
18343|NCT02568254|P5|Participant Flow|Nesolfilcon A/ Etafilcon A/ Nelfilcon A|All subjects that were randomized to receive the nesofilcon A lens first, the etafilcon A lens second and the nelfilcon A lens third.
18344|NCT02568254|P4|Participant Flow|Nelfilcon A/ Etafilcon A/ Nesofilcon A|All subjects that were randomzied to receive the nelfilcon A lens first, the etafilcon A lens second and the nesofilcon A lens third.
18345|NCT02568254|P3|Participant Flow|Nelfilcon A/ Nesofilcon A/ Etafilcon A|All subjects that were randomized to receive the nelfilcon A lens first, the nesofilcon A lens second and the etafilcon A lens third.
18346|NCT02568254|P2|Participant Flow|Etafilcon A/ Nesofilcon A/ Nelfilcon A|All subjects that were randomized to receive the etafilcon A lens first, the nesofilcon A lens second and the nelfilcon A lens third.
18347|NCT02568254|P1|Participant Flow|Etafilcon A/ Nelfilcon A/ Nesofilcon A|All subjects that were randomized to receive the etafilcon A lens first, the nelfilcon A lens second and the nesofilcon A lens third.
18348|NCT02568254|O3|Outcome|Nesofilcon A|All subjects that wore the nesofilcon A lens in any of the 3 periods in the study.
18349|NCT02568254|O2|Outcome|Nelfilcon A|All subjects that wore the nelfilcon A lens in any of the 3 periods of the study.
18350|NCT02568254|O1|Outcome|Etafilcon A|All subjects that wore the etafilcon A lens during any one of the 3 periods in the study.
18351|NCT02568254|E3|Reported Event|Nesofilcon A|All subjects that wore the nesofilcon A lens in any of the 3 periods in the study.
18352|NCT02568254|E2|Reported Event|Nelfilcon A|All subjects that wore the nelfilcon A lens in any of the 3 periods of the study.
18353|NCT02568254|E1|Reported Event|Etafilcon A|All subjects that wore the etafilcon A lens during any one of the 3 periods in the study.
18357|NCT02567552|P2|Participant Flow|Prontogest|"Intramuscular progesterone~Intramuscular progesterone: intramuscular progesterone 50 mg/day"
18358|NCT02567552|P1|Participant Flow|Prolutex|"Subcutaneous progesterone~Subcutaneous progesterone: subcutaneous progesterone 25 mg/day"
18359|NCT02567552|O2|Outcome|Prontogest|"Intramuscular progesterone~Intramuscular progesterone: intramuscular progesterone 50 mg/day"
18360|NCT02567552|O1|Outcome|Prolutex|"Subcutaneous progesterone~Subcutaneous progesterone: subcutaneous progesterone 25 mg/day"
18361|NCT02567552|O2|Outcome|Prontogest|"Intramuscular progesterone~Intramuscular progesterone: intramuscular progesterone 50 mg/day"
18362|NCT02567552|O1|Outcome|Prolutex|"Subcutaneous progesterone~Subcutaneous progesterone: subcutaneous progesterone 25 mg/day"
18363|NCT02567552|O2|Outcome|Prontogest|"Intramuscular progesterone~Intramuscular progesterone: intramuscular progesterone 50 mg/day"
18364|NCT02567552|O1|Outcome|Prolutex|"Subcutaneous progesterone~Subcutaneous progesterone: subcutaneous progesterone 25 mg/day"
18365|NCT02567552|O2|Outcome|Prontogest|"Intramuscular progesterone~Intramuscular progesterone: intramuscular progesterone 50 mg/day"
18366|NCT02567552|O1|Outcome|Prolutex|"Subcutaneous progesterone~Subcutaneous progesterone: subcutaneous progesterone 25 mg/day"
18367|NCT02567552|O2|Outcome|Prontogest|"Intramuscular progesterone~Intramuscular progesterone: intramuscular progesterone 50 mg/day"
18368|NCT02567552|O1|Outcome|Prolutex|"Subcutaneous progesterone~Subcutaneous progesterone: subcutaneous progesterone 25 mg/day"
18369|NCT02567552|O2|Outcome|Prontogest|"Intramuscular progesterone~Intramuscular progesterone: intramuscular progesterone 50 mg/day"
18370|NCT02567552|O1|Outcome|Prolutex|"Subcutaneous progesterone~Subcutaneous progesterone: subcutaneous progesterone 25 mg/day"
18371|NCT02567552|O2|Outcome|Prontogest|"Intramuscular progesterone~Intramuscular progesterone: intramuscular progesterone 50 mg/day"
18372|NCT02567552|O1|Outcome|Prolutex|"Subcutaneous progesterone~Subcutaneous progesterone: subcutaneous progesterone 25 mg/day"
18373|NCT02567552|O2|Outcome|Prontogest|"Intramuscular progesterone~Intramuscular progesterone: intramuscular progesterone 50 mg/day"
18374|NCT02567552|O1|Outcome|Prolutex|"Subcutaneous progesterone~Subcutaneous progesterone: subcutaneous progesterone 25 mg/day"
18375|NCT02567552|O2|Outcome|Prontogest|"Intramuscular progesterone~Intramuscular progesterone: intramuscular progesterone 50 mg/day"
18376|NCT02567552|O1|Outcome|Prolutex|"Subcutaneous progesterone~Subcutaneous progesterone: subcutaneous progesterone 25 mg/day"
18377|NCT02567552|O2|Outcome|Prontogest|"Intramuscular progesterone~Intramuscular progesterone: intramuscular progesterone 50 mg/day"
18378|NCT02567552|O1|Outcome|Prolutex|"Subcutaneous progesterone~Subcutaneous progesterone: subcutaneous progesterone 25 mg/day"
18379|NCT02567552|O2|Outcome|Prontogest|"Intramuscular progesterone~Intramuscular progesterone: intramuscular progesterone 50 mg/day"
18380|NCT02567552|O1|Outcome|Prolutex|"Subcutaneous progesterone~Subcutaneous progesterone: subcutaneous progesterone 25 mg/day"
18381|NCT02567552|O2|Outcome|Prontogest|"Intramuscular progesterone~Intramuscular progesterone: intramuscular progesterone 50 mg/day"
18382|NCT02567552|O1|Outcome|Prolutex|"Subcutaneous progesterone~Subcutaneous progesterone: subcutaneous progesterone 25 mg/day"
18383|NCT02567552|O2|Outcome|Prontogest|"Intramuscular progesterone~Intramuscular progesterone: intramuscular progesterone 50 mg/day"
18384|NCT02567552|O1|Outcome|Prolutex|"Subcutaneous progesterone~Subcutaneous progesterone: subcutaneous progesterone 25 mg/day"
18385|NCT02567552|E2|Reported Event|Prontogest|"Intramuscular progesterone~Intramuscular progesterone: intramuscular progesterone 50 mg/day"
18386|NCT02567552|E1|Reported Event|Prolutex|"Subcutaneous progesterone~Subcutaneous progesterone: subcutaneous progesterone 25 mg/day"
18387|NCT02567188|B1|Baseline|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18388|NCT02567188|P1|Participant Flow|Chronic Kidney Disease (CKD) Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18389|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18390|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18391|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18392|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18393|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18394|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18395|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18396|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18397|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18430|NCT02566759|B4|Baseline|Part 1: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1.
18398|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18399|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18400|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18401|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18402|NCT02567188|O1|Outcome|Cohort of CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18403|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18404|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18405|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18406|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18407|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18408|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18409|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18410|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18411|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18412|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18413|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18414|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18415|NCT02567188|E1|Reported Event|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
18416|NCT02566759|B18|Baseline|Total|Total of all reporting groups
18417|NCT02566759|B17|Baseline|Part 4: TAK-831 (Suspension Fasted+Tablet Fed+Tablet Fasted)|TAK-831 100 mg, suspension, orally, in fasted state, once on Day 1 of Period 1, followed by a 5-day washout period, further followed by TAK-831 100 mg, tablet, orally, in fed state, once on Day 1 of Period 2, followed by a 5-day washout interval, further followed by TAK-831 100 mg, tablet, orally, in fasted state, once on Day 1 of Period 3.
18418|NCT02566759|B16|Baseline|Part 4: TAK-831 (Tablet Fed+Tablet Fasted+Suspension Fasted)|TAK-831 100 mg, tablet, orally, in fed state, once on Day 1 of Period 1, followed by a 5-day washout period, further followed by TAK-831 100 mg, tablet, orally, in fasted state, once on Day 1 of Period 2, followed by a 5-day washout period, further followed by TAK-831 100 mg, suspension, orally, in fasted state, once on Day 1 of Period 3.
18419|NCT02566759|B15|Baseline|Part 4: TAK-831 (Tablet Fasted+Tablet Fed+Suspension Fasted)|TAK-831 100 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, followed by a 5-day washout period, further followed by TAK-831 100 mg, tablet, orally, in fed state, once on Day 1 of Period 2, followed by a 5-day washout period, further followed by TAK-831 100 mg, suspension, orally, in fasted state, once on Day 1 of Period 3.
18420|NCT02566759|B14|Baseline|Part 3: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once daily from Days 1-14.
18421|NCT02566759|B13|Baseline|Part 3: Placebo|TAK-831 placebo-matching suspension, orally, once daily on Days 1-14.
18422|NCT02566759|B12|Baseline|Part 2: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
18423|NCT02566759|B11|Baseline|Part 2: TAK-831 200 mg|TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
18424|NCT02566759|B10|Baseline|Part 2: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
18425|NCT02566759|B9|Baseline|Part 2: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
18426|NCT02566759|B8|Baseline|Part 2: Placebo Pooled|TAK-831 placebo-matching suspension, orally, once on Day 1 and Days 4-16.
18427|NCT02566759|B7|Baseline|Part 1: TAK-831 750 mg|TAK-831 750 mg, suspension, orally, once on Day 1.
18428|NCT02566759|B6|Baseline|Part 1: TAK-831 500 mg|TAK-831 500 mg, suspension, orally, once on Day 1.
18429|NCT02566759|B5|Baseline|Part 1: TAK-831 250 mg|TAK-831 250 mg, suspension, orally, once on Day 1.
18432|NCT02566759|B2|Baseline|Part 1: TAK-831 10 mg|TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
18433|NCT02566759|B1|Baseline|Part 1: Placebo Pooled|TAK-831 placebo-matching suspension, orally, once on Day 1.
18434|NCT02566759|P17|Participant Flow|Part 4: TAK-831 (Suspension Fasted+Tablet Fed+Tablet Fasted)|TAK-831 100 mg, suspension, orally, in fasted state, once on Day 1 of Period 1, followed by a 5-day washout period, further followed by TAK-831 100 mg, tablet, orally, in fed state, once on Day 1 of Period 2, followed by a 5-day washout interval, further followed by TAK-831 100 mg, tablet, orally, in fasted state, once on Day 1 of Period 3.
18435|NCT02566759|P16|Participant Flow|Part 4: TAK-831 (Tablet Fed+Tablet Fasted+Suspension Fasted)|TAK-831 100 mg, tablet, orally, in fed state, once on Day 1 of Period 1, followed by a 5-day washout period, further followed by TAK-831 100 mg, tablet, orally, in fasted state, once on Day 1 of Period 2, followed by a 5-day washout period, further followed by TAK-831 100 mg, suspension, orally, in fasted state, once on Day 1 of Period 3.
18436|NCT02566759|P15|Participant Flow|Part 4: TAK-831 (Tablet Fasted+Tablet Fed+Suspension Fasted)|TAK-831 100 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, followed by a 5-day washout period, further followed by TAK-831 100 mg, tablet, orally, in fed state, once on Day 1 of Period 2, followed by a 5-day washout period, further followed by TAK-831 100 mg, suspension, orally, in fasted state, once on Day 1 of Period 3.
18437|NCT02566759|P14|Participant Flow|Part 3: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once daily from Days 1-14.
18438|NCT02566759|P13|Participant Flow|Part 3: Placebo|TAK-831 placebo-matching suspension, orally, once daily on Days 1-14.
18439|NCT02566759|P12|Participant Flow|Part 2: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
18440|NCT02566759|P11|Participant Flow|Part 2: TAK-831 200 mg|TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
18441|NCT02566759|P10|Participant Flow|Part 2: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
18442|NCT02566759|P9|Participant Flow|Part 2: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
18443|NCT02566759|P8|Participant Flow|Part 2: Placebo Pooled|TAK-831 placebo-matching suspension, orally, once on Day 1 and Days 4-16.
18444|NCT02566759|P7|Participant Flow|Part 1: TAK-831 750 mg|TAK-831 750 mg, suspension, orally, once on Day 1.
18445|NCT02566759|P6|Participant Flow|Part 1: TAK-831 500 mg|TAK-831 500 mg, suspension, orally, once on Day 1.
18446|NCT02566759|P5|Participant Flow|Part 1: TAK-831 250 mg|TAK-831 250 mg, suspension, orally, once on Day 1.
18447|NCT02566759|P4|Participant Flow|Part 1: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1.
18448|NCT02566759|P3|Participant Flow|Part 1: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1.
18449|NCT02566759|P2|Participant Flow|Part 1: TAK-831 10 mg|TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
18450|NCT02566759|P1|Participant Flow|Part 1: Placebo Pooled|TAK-831 placebo-matching suspension, orally, once on Day 1.
18451|NCT02566759|O5|Outcome|Part 3: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once daily from Days 1-14.
18452|NCT02566759|O4|Outcome|Part 2: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
18453|NCT02566759|O3|Outcome|Part 2: TAK-831 200 mg|TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
18454|NCT02566759|O2|Outcome|Part 2: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
18455|NCT02566759|O1|Outcome|Part 2: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
18456|NCT02566759|O13|Outcome|Part 4: TAK-831 100 mg Suspension Fasted|TAK-831 100 mg, suspension, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
18457|NCT02566759|O12|Outcome|Part 4: TAK-831 100 mg Tablet Fed|TAK-831 100 mg, tablet, orally, once in fed state on Day 1 of either Period 1, 2 or 3.
18458|NCT02566759|O11|Outcome|Part 4: TAK-831 100 mg Tablet Fasted|TAK-831 100 mg, tablet, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
18459|NCT02566759|O10|Outcome|Part 2: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
18460|NCT02566759|O9|Outcome|Part 2: TAK-831 200 mg|TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
18461|NCT02566759|O8|Outcome|Part 2: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
18462|NCT02566759|O7|Outcome|Part 2: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
18463|NCT02566759|O6|Outcome|Part 1: TAK-831 750 mg|TAK-831 750 mg, suspension, orally, once on Day 1.
18464|NCT02566759|O5|Outcome|Part 1: TAK-831 500 mg|TAK-831 500 mg, suspension, orally, once on Day 1.
18465|NCT02566759|O4|Outcome|Part 1: TAK-831 250 mg|TAK-831 250 mg, suspension, orally, once on Day 1.
18466|NCT02566759|O3|Outcome|Part 1: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1.
18467|NCT02566759|O2|Outcome|Part 1: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1.
18468|NCT02566759|O1|Outcome|Part 1: TAK-831 10 mg|TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
18469|NCT02566759|O13|Outcome|Part 4: TAK-831 100 mg Suspension Fasted|TAK-831 100 mg, suspension, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
18470|NCT02566759|O12|Outcome|Part 4: TAK-831 100 mg Tablet Fed|TAK-831 100 mg, tablet, orally, once in fed state on Day 1 of either Period 1, 2 or 3.
18471|NCT02566759|O11|Outcome|Part 4: TAK-831 100 mg Tablet Fasted|TAK-831 100 mg, tablet, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
18472|NCT02566759|O10|Outcome|Part 2: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
18473|NCT02566759|O9|Outcome|Part 2: TAK-831 200 mg|TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
18474|NCT02566759|O8|Outcome|Part 2: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
18475|NCT02566759|O7|Outcome|Part 2: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
18476|NCT02566759|O6|Outcome|Part 1: TAK-831 750 mg|TAK-831 750 mg, suspension, orally, once on Day 1.
18477|NCT02566759|O5|Outcome|Part 1: TAK-831 500 mg|TAK-831 500 mg, suspension, orally, once on Day 1.
18478|NCT02566759|O4|Outcome|Part 1: TAK-831 250 mg|TAK-831 250 mg, suspension, orally, once on Day 1.
28125|NCT02468414|O1|Outcome|Group A|TARGTEPO 18-25 IU/kg/day
18481|NCT02566759|O1|Outcome|Part 1: TAK-831 10 mg|TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
18482|NCT02566759|O15|Outcome|Part 4: TAK-831 100 mg Suspension Fasted|TAK-831 100 mg, suspension, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
18483|NCT02566759|O14|Outcome|Part 4: TAK-831 100 mg Tablet Fed|TAK-831 100 mg, tablet, orally, once in fed state on Day 1 of either Period 1, 2 or 3.
18484|NCT02566759|O13|Outcome|Part 4: TAK-831 100 mg Tablet Fasted|TAK-831 100 mg, tablet, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
18485|NCT02566759|O12|Outcome|Part 3: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once daily from Days 1-14.
18486|NCT02566759|O11|Outcome|Part 3: Placebo|TAK-831 placebo-matching suspension, orally, once daily on Days 1-14.
18487|NCT02566759|O10|Outcome|Part 2: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
18488|NCT02566759|O9|Outcome|Part 2: TAK-831 200 mg|TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
18489|NCT02566759|O8|Outcome|Part 2: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
18490|NCT02566759|O7|Outcome|Part 2: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
18491|NCT02566759|O6|Outcome|Part 1: TAK-831 750 mg|TAK-831 750 mg, suspension, orally, once on Day 1.
18492|NCT02566759|O5|Outcome|Part 1: TAK-831 500 mg|TAK-831 500 mg, suspension, orally, once on Day 1.
18493|NCT02566759|O4|Outcome|Part 1: TAK-831 250 mg|TAK-831 250 mg, suspension, orally, once on Day 1.
18494|NCT02566759|O3|Outcome|Part 1: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1.
18495|NCT02566759|O2|Outcome|Part 1: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1.
18496|NCT02566759|O1|Outcome|Part 1: TAK-831 10 mg|TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
18497|NCT02566759|O5|Outcome|Part 3: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once daily from Days 1-14.
18498|NCT02566759|O4|Outcome|Part 2: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
18499|NCT02566759|O3|Outcome|Part 2: TAK-831 200 mg|TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
18500|NCT02566759|O2|Outcome|Part 2: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
18501|NCT02566759|O1|Outcome|Part 2: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
18502|NCT02566759|O13|Outcome|Part 4: TAK-831 100 mg Suspension Fasted|TAK-831 100 mg, suspension, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
18503|NCT02566759|O12|Outcome|Part 4: TAK-831 100 mg Tablet Fed|TAK-831 100 mg, tablet, orally, once in fed state on Day 1 of either Period 1, 2 or 3.
18504|NCT02566759|O11|Outcome|Part 4: TAK-831 100 mg Tablet Fasted|TAK-831 100 mg, tablet, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
18505|NCT02566759|O10|Outcome|Part 2: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
18506|NCT02566759|O9|Outcome|Part 2: TAK-831 200 mg|TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
18507|NCT02566759|O8|Outcome|Part 2: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
18508|NCT02566759|O7|Outcome|Part 2: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
18509|NCT02566759|O6|Outcome|Part 1: TAK-831 750 mg|TAK-831 750 mg, suspension, orally, once on Day 1.
18510|NCT02566759|O5|Outcome|Part 1: TAK-831 500 mg|TAK-831 500 mg, suspension, orally, once on Day 1.
18511|NCT02566759|O4|Outcome|Part 1: TAK-831 250 mg|TAK-831 250 mg, suspension, orally, once on Day 1.
18512|NCT02566759|O3|Outcome|Part 1: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1.
18513|NCT02566759|O2|Outcome|Part 1: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1.
18514|NCT02566759|O1|Outcome|Part 1: TAK-831 10 mg|TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
18515|NCT02566759|O17|Outcome|Part 4: TAK-831 100 mg Suspension Fasted|TAK-831 100 mg, suspension, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
18516|NCT02566759|O16|Outcome|Part 4: TAK-831 100 mg Tablet Fed|TAK-831 100 mg, tablet, orally, once in fed state on Day 1 of either Period 1, 2 or 3.
18517|NCT02566759|O15|Outcome|Part 4: TAK-831 100 mg Tablet Fasted|TAK-831 100 mg, tablet, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
18518|NCT02566759|O14|Outcome|Part 3: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once daily from Days 1-14.
18519|NCT02566759|O13|Outcome|Part 3: Placebo|TAK-831 placebo-matching suspension, orally, once daily on Days 1-14.
18520|NCT02566759|O12|Outcome|Part 2: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
18521|NCT02566759|O11|Outcome|Part 2: TAK-831 200 mg|TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
18522|NCT02566759|O10|Outcome|Part 2: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
18523|NCT02566759|O9|Outcome|Part 2: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
18524|NCT02566759|O8|Outcome|Part 2: Placebo Pooled|TAK-831 placebo-matching suspension, orally, once on Day 1 and Days 4-16.
18525|NCT02566759|O7|Outcome|Part 1: TAK-831 750 mg|TAK-831 750 mg, suspension, orally, once on Day 1.
18526|NCT02566759|O6|Outcome|Part 1: TAK-831 500 mg|TAK-831 500 mg, suspension, orally, once on Day 1.
18527|NCT02566759|O5|Outcome|Part 1: TAK-831 250 mg|TAK-831 250 mg, suspension, orally, once on Day 1.
18528|NCT02566759|O4|Outcome|Part 1: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1.
18529|NCT02566759|O3|Outcome|Part 1: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1.
18530|NCT02566759|O2|Outcome|Part 1: TAK-831 10 mg|TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
18531|NCT02566759|O1|Outcome|Part 1: Placebo Pooled|TAK-831 placebo-matching suspension, orally, once on Day 1.
18532|NCT02566759|O17|Outcome|Part 4: TAK-831 100 mg Suspension Fasted|TAK-831 100 mg, suspension, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
18533|NCT02566759|O16|Outcome|Part 4: TAK-831 100 mg Tablet Fed|TAK-831 100 mg, tablet, orally, once in fed state on Day 1 of either Period 1, 2 or 3.
22273|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
18534|NCT02566759|O15|Outcome|Part 4: TAK-831 100 mg Tablet Fasted|TAK-831 100 mg, tablet, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
18535|NCT02566759|O14|Outcome|Part 3: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once daily from Days 1-14.
18536|NCT02566759|O13|Outcome|Part 3: Placebo|TAK-831 placebo-matching suspension, orally, once daily on Days 1-14.
18537|NCT02566759|O12|Outcome|Part 2: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
18538|NCT02566759|O11|Outcome|Part 2: TAK-831 200 mg|TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
18539|NCT02566759|O10|Outcome|Part 2: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
18540|NCT02566759|O9|Outcome|Part 2: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
18541|NCT02566759|O8|Outcome|Part 2: Placebo Pooled|TAK-831 placebo-matching suspension, orally, once on Day 1 and Days 4-16.
18542|NCT02566759|O7|Outcome|Part 1: TAK-831 750 mg|TAK-831 750 mg, suspension, orally, once on Day 1.
18543|NCT02566759|O6|Outcome|Part 1: TAK-831 500 mg|TAK-831 500 mg, suspension, orally, once on Day 1.
18544|NCT02566759|O5|Outcome|Part 1: TAK-831 250 mg|TAK-831 250 mg, suspension, orally, once on Day 1.
18545|NCT02566759|O4|Outcome|Part 1: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1.
18546|NCT02566759|O3|Outcome|Part 1: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1.
18547|NCT02566759|O2|Outcome|Part 1: TAK-831 10 mg|TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
18548|NCT02566759|O1|Outcome|Part 1: Placebo Pooled|TAK-831 placebo-matching suspension, orally, once on Day 1.
18549|NCT02566759|O17|Outcome|Part 4: TAK-831 100 mg Suspension Fasted|TAK-831 100 mg, suspension, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
18550|NCT02566759|O16|Outcome|Part 4: TAK-831 100 mg Tablet Fed|TAK-831 100 mg, tablet, orally, once in fed state on Day 1 of either Period 1, 2 or 3.
18551|NCT02566759|O15|Outcome|Part 4: TAK-831 100 mg Tablet Fasted|TAK-831 100 mg, tablet, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
18552|NCT02566759|O14|Outcome|Part 3: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once daily from Days 1-14.
18553|NCT02566759|O13|Outcome|Part 3: Placebo|TAK-831 placebo-matching suspension, orally, once daily on Days 1-14.
18554|NCT02566759|O12|Outcome|Part 2: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
18555|NCT02566759|O11|Outcome|Part 2: TAK-831 200 mg|TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
18556|NCT02566759|O10|Outcome|Part 2: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
18557|NCT02566759|O9|Outcome|Part 2: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
18558|NCT02566759|O8|Outcome|Part 2: Placebo Pooled|TAK-831 placebo-matching suspension, orally, once on Day 1 and Days 4-16.
18559|NCT02566759|O7|Outcome|Part 1: TAK-831 750 mg|TAK-831 750 mg, suspension, orally, once on Day 1.
18560|NCT02566759|O6|Outcome|Part 1: TAK-831 500 mg|TAK-831 500 mg, suspension, orally, once on Day 1.
18561|NCT02566759|O5|Outcome|Part 1: TAK-831 250 mg|TAK-831 250 mg, suspension, orally, once on Day 1.
18562|NCT02566759|O4|Outcome|Part 1: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1.
18563|NCT02566759|O3|Outcome|Part 1: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1.
18564|NCT02566759|O2|Outcome|Part 1: TAK-831 10 mg|TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
18565|NCT02566759|O1|Outcome|Part 1: Placebo Pooled|TAK-831 placebo-matching suspension, orally, once on Day 1.
18566|NCT02566759|O17|Outcome|Part 4: TAK-831 100 mg Suspension Fasted|TAK-831 100 mg, suspension, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
18567|NCT02566759|O16|Outcome|Part 4: TAK-831 100 mg Tablet Fed|TAK-831 100 mg, tablet, orally, once in fed state on Day 1 of either Period 1, 2 or 3.
18568|NCT02566759|O15|Outcome|Part 4: TAK-831 100 mg Tablet Fasted|TAK-831 100 mg, tablet, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
18569|NCT02566759|O14|Outcome|Part 3: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once daily from Days 1-14.
18570|NCT02566759|O13|Outcome|Part 3: Placebo|TAK-831 placebo-matching suspension, orally, once daily on Days 1-14.
18571|NCT02566759|O12|Outcome|Part 2: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
18572|NCT02566759|O11|Outcome|Part 2: TAK-831 200 mg|TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
18573|NCT02566759|O10|Outcome|Part 2: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
18574|NCT02566759|O9|Outcome|Part 2: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
18575|NCT02566759|O8|Outcome|Part 2: Placebo Pooled|TAK-831 placebo-matching suspension, orally, once on Day 1 and Days 4-16.
18576|NCT02566759|O7|Outcome|Part 1: TAK-831 750 mg|TAK-831 750 mg, suspension, orally, once on Day 1.
18577|NCT02566759|O6|Outcome|Part 1: TAK-831 500 mg|TAK-831 500 mg, suspension, orally, once on Day 1.
18578|NCT02566759|O5|Outcome|Part 1: TAK-831 250 mg|TAK-831 250 mg, suspension, orally, once on Day 1.
18579|NCT02566759|O4|Outcome|Part 1: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1.
18580|NCT02566759|O3|Outcome|Part 1: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1.
18581|NCT02566759|O2|Outcome|Part 1: TAK-831 10 mg|TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
18582|NCT02566759|O1|Outcome|Part 1: Placebo Pooled|TAK-831 placebo-matching suspension, orally, once on Day 1.
18583|NCT02566759|E17|Reported Event|Part 4: TAK-831 100 mg Suspension Fasted|TAK-831 100 mg, suspension, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
18584|NCT02566759|E16|Reported Event|Part 4: TAK-831 100 mg Tablet Fed|TAK-831 100 mg, tablet, orally, once in fed state on Day 1 of either Period 1, 2 or 3.
18585|NCT02566759|E15|Reported Event|Part 4: TAK-831 100 mg Tablet Fasted|TAK-831 100 mg, tablet, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
18586|NCT02566759|E14|Reported Event|Part 3: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once daily from Days 1-14.
18587|NCT02566759|E13|Reported Event|Part 3: Placebo|TAK-831 placebo-matching suspension, orally, once daily on Days 1-14.
18588|NCT02566759|E12|Reported Event|Part 2: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
18589|NCT02566759|E11|Reported Event|Part 2: TAK-831 200 mg|TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
18590|NCT02566759|E10|Reported Event|Part 2: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
18591|NCT02566759|E9|Reported Event|Part 2: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
18592|NCT02566759|E8|Reported Event|Part 2: Placebo Pooled|TAK-831 placebo-matching suspension, orally, once on Day 1 and Days 4-16.
18593|NCT02566759|E7|Reported Event|Part 1: TAK-831 750 mg|TAK-831 750 mg, suspension, orally, once on Day 1.
18594|NCT02566759|E6|Reported Event|Part 1: TAK-831 500 mg|TAK-831 500 mg, suspension, orally, once on Day 1.
18595|NCT02566759|E5|Reported Event|Part 1: TAK-831 250 mg|TAK-831 250 mg, suspension, orally, once on Day 1.
18596|NCT02566759|E4|Reported Event|Part 1: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1.
18597|NCT02566759|E3|Reported Event|Part 1: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1.
18598|NCT02566759|E2|Reported Event|Part 1: TAK-831 10 mg|TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
18599|NCT02566759|E1|Reported Event|Part 1: Placebo Pooled|TAK-831 placebo-matching suspension, orally, once on Day 1.
18600|NCT02566005|B3|Baseline|Total|Total of all reporting groups
18601|NCT02566005|B2|Baseline|Misoprostol and Foley Bulb Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. In addition, a foley bulb will be inserted digitally or by direct visualization with the use of a sterile speculum. The foley will be inserted through the internal os and filled with 60cc of normal saline. The catheter will be taped to the patient’s inner thigh under gentle traction. When the foley bulb has fallen out (spontaneous expulsion), further management of labor depends on the labor team. If this does not occur, the catheter will be deflated and removed after 24 hours. Oxytocin will be initiated in those patients who were not in labor after expulsion or removal of the catheter.
18602|NCT02566005|B1|Baseline|Misoprostol Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. Once the cervix becomes favorable or if the patient is in active labor, or if there is no progress for 24 hours, misoprostol administration will be discontinued. Further management of labor will depend on the labor team. (25mcg tablets are not available commercially; a 100mcg table is cut into fourths by the hospital pharmacist.)
18603|NCT02566005|P2|Participant Flow|Misoprostol and Foley Bulb Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. In addition, a foley bulb will be inserted digitally or by direct visualization with the use of a sterile speculum. The foley will be inserted through the internal os and filled with 60cc of normal saline. The catheter will be taped to the patient’s inner thigh under gentle traction. When the foley bulb has fallen out (spontaneous expulsion), further management of labor depends on the labor team. If this does not occur, the catheter will be deflated and removed after 24 hours. Oxytocin will be initiated in those patients who were not in labor after expulsion or removal of the catheter.
18604|NCT02566005|P1|Participant Flow|Misoprostol Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. Once the cervix becomes favorable or if the patient is in active labor, or if there is no progress for 24 hours, misoprostol administration will be discontinued. Further management of labor will depend on the labor team. (25mcg tablets are not available commercially; a 100mcg table is cut into fourths by the hospital pharmacist.)
18605|NCT02566005|O2|Outcome|Misoprostol and Foley Bulb Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. In addition, a foley bulb will be inserted digitally or by direct visualization with the use of a sterile speculum. The foley will be inserted through the internal os and filled with 60cc of normal saline. The catheter will be taped to the patient’s inner thigh under gentle traction. When the foley bulb has fallen out (spontaneous expulsion), further management of labor depends on the labor team. If this does not occur, the catheter will be deflated and removed after 24 hours. Oxytocin will be initiated in those patients who were not in labor after expulsion or removal of the catheter.
18606|NCT02566005|O1|Outcome|Misoprostol Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. Once the cervix becomes favorable or if the patient is in active labor, or if there is no progress for 24 hours, misoprostol administration will be discontinued. Further management of labor will depend on the labor team. (25mcg tablets are not available commercially; a 100mcg table is cut into fourths by the hospital pharmacist.)
18607|NCT02566005|O2|Outcome|Misoprostol and Foley Bulb Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. In addition, a foley bulb will be inserted digitally or by direct visualization with the use of a sterile speculum. The foley will be inserted through the internal os and filled with 60cc of normal saline. The catheter will be taped to the patient’s inner thigh under gentle traction. When the foley bulb has fallen out (spontaneous expulsion), further management of labor depends on the labor team. If this does not occur, the catheter will be deflated and removed after 24 hours. Oxytocin will be initiated in those patients who were not in labor after expulsion or removal of the catheter.
18608|NCT02566005|O1|Outcome|Misoprostol Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. Once the cervix becomes favorable or if the patient is in active labor, or if there is no progress for 24 hours, misoprostol administration will be discontinued. Further management of labor will depend on the labor team. (25mcg tablets are not available commercially; a 100mcg table is cut into fourths by the hospital pharmacist.)
18609|NCT02566005|O2|Outcome|Misoprostol and Foley Bulb Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. In addition, a foley bulb will be inserted digitally or by direct visualization with the use of a sterile speculum. The foley will be inserted through the internal os and filled with 60cc of normal saline. The catheter will be taped to the patient’s inner thigh under gentle traction. When the foley bulb has fallen out (spontaneous expulsion), further management of labor depends on the labor team. If this does not occur, the catheter will be deflated and removed after 24 hours. Oxytocin will be initiated in those patients who were not in labor after expulsion or removal of the catheter.
18639|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18610|NCT02566005|O1|Outcome|Misoprostol Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. Once the cervix becomes favorable or if the patient is in active labor, or if there is no progress for 24 hours, misoprostol administration will be discontinued. Further management of labor will depend on the labor team. (25mcg tablets are not available commercially; a 100mcg table is cut into fourths by the hospital pharmacist.)
18611|NCT02566005|O2|Outcome|Misoprostol and Foley Bulb Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. In addition, a foley bulb will be inserted digitally or by direct visualization with the use of a sterile speculum. The foley will be inserted through the internal os and filled with 60cc of normal saline. The catheter will be taped to the patient’s inner thigh under gentle traction. When the foley bulb has fallen out (spontaneous expulsion), further management of labor depends on the labor team. If this does not occur, the catheter will be deflated and removed after 24 hours. Oxytocin will be initiated in those patients who were not in labor after expulsion or removal of the catheter.
18612|NCT02566005|O1|Outcome|Misoprostol Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. Once the cervix becomes favorable or if the patient is in active labor, or if there is no progress for 24 hours, misoprostol administration will be discontinued. Further management of labor will depend on the labor team. (25mcg tablets are not available commercially; a 100mcg table is cut into fourths by the hospital pharmacist.)
18613|NCT02566005|O2|Outcome|Misoprostol and Foley Bulb Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. In addition, a foley bulb will be inserted digitally or by direct visualization with the use of a sterile speculum. The foley will be inserted through the internal os and filled with 60cc of normal saline. The catheter will be taped to the patient’s inner thigh under gentle traction. When the foley bulb has fallen out (spontaneous expulsion), further management of labor depends on the labor team. If this does not occur, the catheter will be deflated and removed after 24 hours. Oxytocin will be initiated in those patients who were not in labor after expulsion or removal of the catheter.
18614|NCT02566005|O1|Outcome|Misoprostol Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. Once the cervix becomes favorable or if the patient is in active labor, or if there is no progress for 24 hours, misoprostol administration will be discontinued. Further management of labor will depend on the labor team. (25mcg tablets are not available commercially; a 100mcg table is cut into fourths by the hospital pharmacist.)
18615|NCT02566005|O2|Outcome|Misoprostol and Foley Bulb Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. In addition, a foley bulb will be inserted digitally or by direct visualization with the use of a sterile speculum. The foley will be inserted through the internal os and filled with 60cc of normal saline. The catheter will be taped to the patient’s inner thigh under gentle traction. When the foley bulb has fallen out (spontaneous expulsion), further management of labor depends on the labor team. If this does not occur, the catheter will be deflated and removed after 24 hours. Oxytocin will be initiated in those patients who were not in labor after expulsion or removal of the catheter.
18616|NCT02566005|O1|Outcome|Misoprostol Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. Once the cervix becomes favorable or if the patient is in active labor, or if there is no progress for 24 hours, misoprostol administration will be discontinued. Further management of labor will depend on the labor team. (25mcg tablets are not available commercially; a 100mcg table is cut into fourths by the hospital pharmacist.)
18617|NCT02566005|O2|Outcome|Misoprostol and Foley Bulb Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. In addition, a foley bulb will be inserted digitally or by direct visualization with the use of a sterile speculum. The foley will be inserted through the internal os and filled with 60cc of normal saline. The catheter will be taped to the patient’s inner thigh under gentle traction. When the foley bulb has fallen out (spontaneous expulsion), further management of labor depends on the labor team. If this does not occur, the catheter will be deflated and removed after 24 hours. Oxytocin will be initiated in those patients who were not in labor after expulsion or removal of the catheter.
18618|NCT02566005|O1|Outcome|Misoprostol Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. Once the cervix becomes favorable or if the patient is in active labor, or if there is no progress for 24 hours, misoprostol administration will be discontinued. Further management of labor will depend on the labor team. (25mcg tablets are not available commercially; a 100mcg table is cut into fourths by the hospital pharmacist.)
18619|NCT02566005|O2|Outcome|Misoprostol and Foley Bulb Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. In addition, a foley bulb will be inserted digitally or by direct visualization with the use of a sterile speculum. The foley will be inserted through the internal os and filled with 60cc of normal saline. The catheter will be taped to the patient’s inner thigh under gentle traction. When the foley bulb has fallen out (spontaneous expulsion), further management of labor depends on the labor team. If this does not occur, the catheter will be deflated and removed after 24 hours. Oxytocin will be initiated in those patients who were not in labor after expulsion or removal of the catheter.
18620|NCT02566005|O1|Outcome|Misoprostol Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. Once the cervix becomes favorable or if the patient is in active labor, or if there is no progress for 24 hours, misoprostol administration will be discontinued. Further management of labor will depend on the labor team. (25mcg tablets are not available commercially; a 100mcg table is cut into fourths by the hospital pharmacist.)
18621|NCT02566005|O2|Outcome|Misoprostol and Foley Bulb Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. In addition, a foley bulb will be inserted digitally or by direct visualization with the use of a sterile speculum. The foley will be inserted through the internal os and filled with 60cc of normal saline. The catheter will be taped to the patient’s inner thigh under gentle traction. When the foley bulb has fallen out (spontaneous expulsion), further management of labor depends on the labor team. If this does not occur, the catheter will be deflated and removed after 24 hours. Oxytocin will be initiated in those patients who were not in labor after expulsion or removal of the catheter.
18622|NCT02566005|O1|Outcome|Misoprostol Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. Once the cervix becomes favorable or if the patient is in active labor, or if there is no progress for 24 hours, misoprostol administration will be discontinued. Further management of labor will depend on the labor team. (25mcg tablets are not available commercially; a 100mcg table is cut into fourths by the hospital pharmacist.)
18623|NCT02566005|O2|Outcome|Misoprostol and Foley Bulb Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. In addition, a foley bulb will be inserted digitally or by direct visualization with the use of a sterile speculum. The foley will be inserted through the internal os and filled with 60cc of normal saline. The catheter will be taped to the patient’s inner thigh under gentle traction. When the foley bulb has fallen out (spontaneous expulsion), further management of labor depends on the labor team. If this does not occur, the catheter will be deflated and removed after 24 hours. Oxytocin will be initiated in those patients who were not in labor after expulsion or removal of the catheter.
18624|NCT02566005|O1|Outcome|Misoprostol Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. Once the cervix becomes favorable or if the patient is in active labor, or if there is no progress for 24 hours, misoprostol administration will be discontinued. Further management of labor will depend on the labor team. (25mcg tablets are not available commercially; a 100mcg table is cut into fourths by the hospital pharmacist.)
18625|NCT02566005|O2|Outcome|Misoprostol and Foley Bulb Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. In addition, a foley bulb will be inserted digitally or by direct visualization with the use of a sterile speculum. The foley will be inserted through the internal os and filled with 60cc of normal saline. The catheter will be taped to the patient’s inner thigh under gentle traction. When the foley bulb has fallen out (spontaneous expulsion), further management of labor depends on the labor team. If this does not occur, the catheter will be deflated and removed after 24 hours. Oxytocin will be initiated in those patients who were not in labor after expulsion or removal of the catheter.
18626|NCT02566005|O1|Outcome|Misoprostol Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. Once the cervix becomes favorable or if the patient is in active labor, or if there is no progress for 24 hours, misoprostol administration will be discontinued. Further management of labor will depend on the labor team. (25mcg tablets are not available commercially; a 100mcg table is cut into fourths by the hospital pharmacist.)
18627|NCT02566005|O2|Outcome|Misoprostol and Foley Bulb Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. In addition, a foley bulb will be inserted digitally or by direct visualization with the use of a sterile speculum. The foley will be inserted through the internal os and filled with 60cc of normal saline. The catheter will be taped to the patient’s inner thigh under gentle traction. When the foley bulb has fallen out (spontaneous expulsion), further management of labor depends on the labor team. If this does not occur, the catheter will be deflated and removed after 24 hours. Oxytocin will be initiated in those patients who were not in labor after expulsion or removal of the catheter.
18628|NCT02566005|O1|Outcome|Misoprostol Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. Once the cervix becomes favorable or if the patient is in active labor, or if there is no progress for 24 hours, misoprostol administration will be discontinued. Further management of labor will depend on the labor team. (25mcg tablets are not available commercially; a 100mcg table is cut into fourths by the hospital pharmacist.)
18629|NCT02566005|E2|Reported Event|Misoprostol and Foley Bulb Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. In addition, a foley bulb will be inserted digitally or by direct visualization with the use of a sterile speculum. The foley will be inserted through the internal os and filled with 60cc of normal saline. The catheter will be taped to the patient’s inner thigh under gentle traction. When the foley bulb has fallen out (spontaneous expulsion), further management of labor depends on the labor team. If this does not occur, the catheter will be deflated and removed after 24 hours. Oxytocin will be initiated in those patients who were not in labor after expulsion or removal of the catheter.
18630|NCT02566005|E1|Reported Event|Misoprostol Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. Once the cervix becomes favorable or if the patient is in active labor, or if there is no progress for 24 hours, misoprostol administration will be discontinued. Further management of labor will depend on the labor team. (25mcg tablets are not available commercially; a 100mcg table is cut into fourths by the hospital pharmacist.)
18631|NCT02565628|B3|Baseline|Total|Total of all reporting groups
18632|NCT02565628|B2|Baseline|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18633|NCT02565628|B1|Baseline|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18634|NCT02565628|P2|Participant Flow|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18635|NCT02565628|P1|Participant Flow|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18636|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18637|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18638|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
19200|NCT02564029|O3|Outcome|Lorazepam 2 mg|One (1) lorazepam 2 mg tablet and seven (7) PF-06372865 placebo tablets.
18640|NCT02565628|O2|Outcome|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18641|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18642|NCT02565628|O2|Outcome|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18643|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18644|NCT02565628|O2|Outcome|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18645|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18646|NCT02565628|O2|Outcome|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18647|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18648|NCT02565628|O2|Outcome|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18649|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18650|NCT02565628|O2|Outcome|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18651|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18652|NCT02565628|O2|Outcome|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18653|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18654|NCT02565628|O2|Outcome|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18655|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18656|NCT02565628|O2|Outcome|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18657|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18658|NCT02565628|O2|Outcome|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18659|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18660|NCT02565628|E2|Reported Event|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18661|NCT02565628|E1|Reported Event|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
18662|NCT02565381|B4|Baseline|Total|Total of all reporting groups
18663|NCT02565381|B3|Baseline|Text Messaging (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Text messages to support smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
18664|NCT02565381|B2|Baseline|Financial Rewards (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Contingent financial rewards for smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
18665|NCT02565381|B1|Baseline|Control (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
18666|NCT02565381|P3|Participant Flow|Text Messaging (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Text messages to support smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
18667|NCT02565381|P2|Participant Flow|Financial Rewards (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Contingent financial rewards for smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
18668|NCT02565381|P1|Participant Flow|Control (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
18669|NCT02565381|O3|Outcome|Text Messaging (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Text messages to support smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
18670|NCT02565381|O2|Outcome|Financial Rewards (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Contingent financial rewards for smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
18671|NCT02565381|O1|Outcome|Control (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
18672|NCT02565381|O3|Outcome|Text Messaging (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Text messages to support smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
18673|NCT02565381|O2|Outcome|Financial Rewards (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Contingent financial rewards for smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
18674|NCT02565381|O1|Outcome|Control (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
19201|NCT02564029|O2|Outcome|PF-06372865 52.5 mg|One (1) lorazepam placebo tablet and seven (7) PF-06372865 7.5 mg tablets.
18675|NCT02565381|O3|Outcome|Text Messaging (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Text messages to support smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
18676|NCT02565381|O2|Outcome|Financial Rewards (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Contingent financial rewards for smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
18677|NCT02565381|O1|Outcome|Control (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
18678|NCT02565381|O3|Outcome|Text Messaging (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Text messages to support smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
18679|NCT02565381|O2|Outcome|Financial Rewards (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Contingent financial rewards for smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
18680|NCT02565381|O1|Outcome|Control (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
18681|NCT02565381|O3|Outcome|Text Messaging (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Text messages to support smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
18682|NCT02565381|O2|Outcome|Financial Rewards (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Contingent financial rewards for smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
18683|NCT02565381|O1|Outcome|Control (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
18684|NCT02565381|O3|Outcome|Text Messaging (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Text messages to support smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
18685|NCT02565381|O2|Outcome|Financial Rewards (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Contingent financial rewards for smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
18686|NCT02565381|O1|Outcome|Control (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
18687|NCT02565381|O3|Outcome|Text Messaging (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Text messages to support smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
18688|NCT02565381|O2|Outcome|Financial Rewards (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Contingent financial rewards for smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
18689|NCT02565381|O1|Outcome|Control (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
18690|NCT02565381|O3|Outcome|Text Messaging (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Text messages to support smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
18691|NCT02565381|O2|Outcome|Financial Rewards (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Contingent financial rewards for smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
18692|NCT02565381|O1|Outcome|Control (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
18693|NCT02565381|O3|Outcome|Text Messaging (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Text messages to support smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
18694|NCT02565381|O2|Outcome|Financial Rewards (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Contingent financial rewards for smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
18695|NCT02565381|O1|Outcome|Control (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
18696|NCT02565381|O3|Outcome|Text Messaging (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Text messages to support smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
18697|NCT02565381|O2|Outcome|Financial Rewards (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Contingent financial rewards for smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
18698|NCT02565381|O1|Outcome|Control (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
18699|NCT02565381|O3|Outcome|Text Messaging (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Text messages to support smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
18700|NCT02565381|O2|Outcome|Financial Rewards (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Contingent financial rewards for smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
18701|NCT02565381|O1|Outcome|Control (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
18702|NCT02565381|E3|Reported Event|Text Messaging (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Text messages to support smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
18703|NCT02565381|E2|Reported Event|Financial Rewards (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Contingent financial rewards for smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
18704|NCT02565381|E1|Reported Event|Control (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
18705|NCT02564211|B1|Baseline|Ipragliflozin|Ipragliflozin one 50 mg tablet co-administered with one 50 mg sitagliptin once daily (QD) for 52 weeks in addition to diet and exercise therapy.
18706|NCT02564211|P1|Participant Flow|Ipragliflozin|Ipragliflozin one 50 mg tablet co-administered with one 50 mg sitagliptin once daily (QD) for 52 weeks in addition to diet and exercise therapy.
18707|NCT02564211|O1|Outcome|Ipragliflozin|Ipragliflozin one 50 mg tablet co-administered with one 50 mg sitagliptin once daily (QD) for 52 weeks in addition to diet and exercise therapy.
18708|NCT02564211|O1|Outcome|Ipragliflozin|Ipragliflozin one 50 mg tablet co-administered with one 50 mg sitagliptin once daily (QD) for 52 weeks in addition to diet and exercise therapy.
18709|NCT02564211|O1|Outcome|Ipragliflozin|Ipragliflozin one 50 mg tablet co-administered with one 50 mg sitagliptin once daily (QD) for 52 weeks in addition to diet and exercise therapy.
18710|NCT02564211|E1|Reported Event|Ipragliflozin 50 mg|Ipragliflozin one 50 mg tablet co-administered with one 50 mg sitagliptin once daily (QD) for 52 weeks in addition to diet and exercise therapy.
18711|NCT02564055|B7|Baseline|Total|Total of all reporting groups
18712|NCT02564055|B6|Baseline|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18713|NCT02564055|B5|Baseline|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18714|NCT02564055|B4|Baseline|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18715|NCT02564055|B3|Baseline|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18716|NCT02564055|B2|Baseline|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18717|NCT02564055|B1|Baseline|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18718|NCT02564055|P6|Participant Flow|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks.
18719|NCT02564055|P5|Participant Flow|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks.
18720|NCT02564055|P4|Participant Flow|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18721|NCT02564055|P3|Participant Flow|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18722|NCT02564055|P2|Participant Flow|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18723|NCT02564055|P1|Participant Flow|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18724|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18725|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18726|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18727|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18728|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18729|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18730|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18731|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18732|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18733|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18734|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
22274|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
18735|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18736|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18737|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18738|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18739|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18740|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18741|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18742|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18743|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18744|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18745|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18746|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18747|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18748|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18749|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18750|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18751|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18752|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18753|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18754|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18755|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18756|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18757|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18758|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18759|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18760|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18761|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18762|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18763|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18764|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18765|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18766|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18767|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18768|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18769|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18770|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18771|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18772|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18773|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18774|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18775|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18776|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18777|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18778|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18779|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18780|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18781|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18782|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18783|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18784|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18785|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18786|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18787|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18788|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18789|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18790|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18791|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18792|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18793|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18794|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18795|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18796|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18797|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18798|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18799|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18800|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18801|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18802|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18803|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18804|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18805|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18806|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18807|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18808|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18809|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18810|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18811|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18812|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18813|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18814|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18815|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18816|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18817|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18818|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18819|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18820|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18821|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18822|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18823|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18824|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18825|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18826|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18827|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18828|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18829|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18830|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18831|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18832|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18833|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18834|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18835|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18836|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18837|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18838|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18839|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18840|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18841|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18842|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18843|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18844|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18845|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18846|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18847|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18848|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18849|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18850|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18851|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18852|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18853|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18854|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18855|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18856|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18857|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18858|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18859|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18860|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18861|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18862|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18863|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18864|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18865|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18866|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18867|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18868|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18869|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18870|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18871|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18872|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18873|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18874|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18875|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18876|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18877|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18878|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18879|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18880|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18881|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18882|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18883|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18884|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18885|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18886|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18887|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18888|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18889|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18890|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18891|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18892|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18893|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18894|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18895|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18896|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18897|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18898|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18899|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18900|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18901|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18902|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18903|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18904|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18905|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18906|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18907|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18908|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18909|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18910|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18911|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18912|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18913|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18914|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18915|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18916|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18917|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18918|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18919|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18920|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18921|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18922|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18923|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18924|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18925|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18926|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18927|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18928|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18929|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18930|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18931|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18932|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18933|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18934|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18935|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18936|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18937|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18938|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18939|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18940|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18941|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18942|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18943|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18944|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18945|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18946|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18947|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18948|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18949|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18950|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18951|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18952|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18953|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18954|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18955|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18956|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18957|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18958|NCT02564055|O6|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
18959|NCT02564055|O5|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
18960|NCT02564055|O4|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18961|NCT02564055|O3|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18962|NCT02564055|O2|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
18963|NCT02564055|O1|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
18964|NCT02564055|E6|Reported Event|Vehicle Cream Once Daily|Subjects will apply a thin layer of vehicle topical cream once daily (evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).
18965|NCT02564055|E5|Reported Event|Vehicle Cream Twice Daily|Subjects will apply a thin layer of vehicle topical cream twice daily (morning and evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).
18966|NCT02564055|E4|Reported Event|GSK2894512 0.5% Cream Once Daily|Subjects will apply a thin layer of GSK2894512 0.5% (5 mg/g) topical cream once daily (evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).
18967|NCT02564055|E3|Reported Event|GSK2894512 0.5% Cream Twice Daily|Subjects will apply a thin layer of GSK2894512 0.5% (5 mg/g) topical cream twice daily (morning and evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).
18968|NCT02564055|E2|Reported Event|GSK2894512 1% Cream Once Daily|Subjects will apply a thin layer of GSK2894512 1% (10 mg/g) topical cream once daily (evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).
18969|NCT02564055|E1|Reported Event|GSK2894512 1% Cream Twice Daily|Subjects will apply a thin layer of GSK2894512 1% (10 milligram per gram [mg/g]) topical cream twice daily (morning and evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).
18970|NCT02564042|B7|Baseline|Total|Total of all reporting groups
18971|NCT02564042|B6|Baseline|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18972|NCT02564042|B5|Baseline|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18973|NCT02564042|B4|Baseline|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18974|NCT02564042|B3|Baseline|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18975|NCT02564042|B2|Baseline|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18976|NCT02564042|B1|Baseline|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18977|NCT02564042|P6|Participant Flow|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18978|NCT02564042|P5|Participant Flow|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18979|NCT02564042|P4|Participant Flow|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18980|NCT02564042|P3|Participant Flow|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18981|NCT02564042|P2|Participant Flow|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18982|NCT02564042|P1|Participant Flow|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18983|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18984|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18985|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18986|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18987|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18988|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
28126|NCT02468414|E2|Reported Event|Group B|TARGTEPO 35-45 IU/kg/day
18989|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18990|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18991|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18992|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18993|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18994|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18995|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18996|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18997|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18998|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
18999|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19000|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19001|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19002|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19003|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19004|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19005|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19006|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19007|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19008|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19009|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19010|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19011|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19012|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19013|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19014|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19202|NCT02564029|O1|Outcome|PF-06372865 17.5 mg|One (1) lorazepam placebo tablet and seven (7) PF-06372865 2.5 mg tablets.
19015|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19016|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19017|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19018|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19019|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19020|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19021|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19022|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19023|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19024|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19025|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19026|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19027|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19028|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19029|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19030|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19031|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19032|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19033|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19034|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19035|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19036|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19037|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19038|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19039|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19040|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
22275|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
19041|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19042|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19043|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19044|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19045|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19046|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19047|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19048|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19049|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19050|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19051|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19052|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19053|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19054|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19055|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19056|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19057|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19058|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19059|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19060|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19061|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19062|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19063|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19064|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19065|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19066|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
28127|NCT02468414|E1|Reported Event|Group A|TARGTEPO 18-25 IU/kg/day
19067|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19068|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19069|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19070|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19071|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19072|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19073|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19074|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19075|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19076|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19077|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19078|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19079|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19080|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19081|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19082|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19083|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19084|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19085|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19086|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19087|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19088|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19089|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19090|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19091|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19092|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19203|NCT02564029|O4|Outcome|Placebo|One (1) lorazepam placebo tablet and seven (7) PF-06372865 placebo tablets.
19093|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19094|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19095|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19096|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19097|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19098|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19099|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19100|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19101|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19102|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19103|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19104|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19105|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19106|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19107|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19108|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19109|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19110|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19111|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19112|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19113|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19114|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19115|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19116|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19117|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19118|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
22281|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
19119|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19120|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19121|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19122|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19123|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19124|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19125|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19126|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19127|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19128|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19129|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19130|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19131|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19132|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19133|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19134|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19135|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19136|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19137|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19138|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19139|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19140|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19141|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19142|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19143|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19144|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
28128|NCT02468154|B3|Baseline|Total|Total of all reporting groups
19145|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19146|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19147|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19148|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19149|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19150|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19151|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19152|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19153|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19154|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19155|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19156|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19157|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19158|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19159|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19160|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19161|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19162|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19163|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19164|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19165|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19166|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19167|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19168|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19169|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19170|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19204|NCT02564029|O3|Outcome|Lorazepam 2 mg|One (1) lorazepam 2 mg tablet and seven (7) PF-06372865 placebo tablets.
19171|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19172|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19173|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19174|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19175|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19176|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19177|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19178|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19179|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19180|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19181|NCT02564042|O6|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19182|NCT02564042|O5|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19183|NCT02564042|O4|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19184|NCT02564042|O3|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19185|NCT02564042|O2|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19186|NCT02564042|O1|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19187|NCT02564042|E6|Reported Event|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19188|NCT02564042|E5|Reported Event|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19189|NCT02564042|E4|Reported Event|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19190|NCT02564042|E3|Reported Event|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19191|NCT02564042|E2|Reported Event|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19192|NCT02564042|E1|Reported Event|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
19193|NCT02564029|B1|Baseline|All Participants|A total of 7 participants were enrolled and assigned to study treatment.
19194|NCT02564029|P1|Participant Flow|All Study Participants|Subjects were randomly allocated to one of 4 different treatment sequences that each included the 4 treatment groups: Placebo, PF-06372865 17.5 mg, PF-06372865 52.5 mg and Lorazepam 2 mg.
19195|NCT02564029|O4|Outcome|Placebo|One (1) lorazepam placebo tablet and seven (7) PF-06372865 placebo tablets.
19196|NCT02564029|O3|Outcome|Lorazepam 2 mg|One (1) lorazepam 2 mg tablet and seven (7) PF-06372865 placebo tablets.
19197|NCT02564029|O2|Outcome|PF-06372865 52.5 mg|One (1) lorazepam placebo tablet and seven (7) PF-06372865 7.5 mg tablets.
19198|NCT02564029|O1|Outcome|PF-06372865 17.5 mg|One (1) lorazepam placebo tablet and seven (7) PF-06372865 2.5 mg tablets.
19199|NCT02564029|O4|Outcome|Placebo|One (1) lorazepam placebo tablet and seven (7) PF-06372865 placebo tablets.
22282|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
19205|NCT02564029|O2|Outcome|PF-06372865 52.5 mg|One (1) lorazepam placebo tablet and seven (7) PF-06372865 7.5 mg tablets.
19206|NCT02564029|O1|Outcome|PF-06372865 17.5 mg|One (1) lorazepam placebo tablet and seven (7) PF-06372865 2.5 mg tablets.
19207|NCT02564029|O4|Outcome|Placebo|One (1) lorazepam placebo tablet and seven (7) PF-06372865 placebo tablets.
19208|NCT02564029|O3|Outcome|Lorazepam 2 mg|One (1) lorazepam 2 mg tablet and seven (7) PF-06372865 placebo tablets.
19209|NCT02564029|O2|Outcome|PF-06372865 52.5 mg|One (1) lorazepam placebo tablet and seven (7) PF-06372865 7.5 mg tablets.
19210|NCT02564029|O1|Outcome|PF-06372865 17.5 mg|One (1) lorazepam placebo tablet and seven (7) PF-06372865 2.5 mg tablets.
19211|NCT02564029|O1|Outcome|Lorazepam 2 mg|One (1) lorazepam 2 mg tablet and seven (7) PF-06372865 placebo tablets.
19212|NCT02564029|O2|Outcome|PF-06372865 52.5 mg|One (1) lorazepam placebo tablet and seven (7) PF-06372865 7.5 mg tablets.
19213|NCT02564029|O1|Outcome|PF-06372865 17.5 mg|One (1) lorazepam placebo tablet and seven (7) PF-06372865 2.5 mg tablets.
19214|NCT02564029|O2|Outcome|PF-06372865 52.5 mg|One (1) lorazepam placebo tablet and seven (7) PF-06372865 7.5 mg tablets.
19215|NCT02564029|O1|Outcome|PF-06372865 17.5 mg|One (1) lorazepam placebo tablet and seven (7) PF-06372865 2.5 mg tablets.
19216|NCT02564029|O2|Outcome|PF-06372865 52.5 mg|One (1) lorazepam placebo tablet and seven (7) PF-06372865 7.5 mg tablets.
19217|NCT02564029|O1|Outcome|PF-06372865 17.5 mg|One (1) lorazepam placebo tablet and seven (7) PF-06372865 2.5 mg tablets.
19218|NCT02564029|O4|Outcome|Placebo|One (1) lorazepam placebo tablet and seven (7) PF-06372865 placebo tablets.
19219|NCT02564029|O3|Outcome|Lorazepam 2 mg|One (1) lorazepam 2 mg tablet and seven (7) PF-06372865 placebo tablets.
19220|NCT02564029|O2|Outcome|PF-06372865 52.5 mg|One (1) lorazepam placebo tablet and seven (7) PF-06372865 7.5 mg tablets.
19221|NCT02564029|O1|Outcome|PF-06372865 17.5 mg|One (1) lorazepam placebo tablet and seven (7) PF-06372865 2.5 mg tablets.
19222|NCT02564029|O4|Outcome|Placebo|One (1) lorazepam placebo tablet and seven (7) PF-06372865 placebo tablets.
19223|NCT02564029|O3|Outcome|Lorazepam 2 mg|One (1) lorazepam 2 mg tablet and seven (7) PF-06372865 placebo tablets.
19224|NCT02564029|O2|Outcome|PF-06372865 52.5 mg|One (1) lorazepam placebo tablet and seven (7) PF-06372865 7.5 mg tablets.
19225|NCT02564029|O1|Outcome|PF-06372865 17.5 mg|One (1) lorazepam placebo tablet and seven (7) PF-06372865 2.5 mg tablets.
19226|NCT02564029|O4|Outcome|Placebo|One (1) lorazepam placebo tablet and seven (7) PF-06372865 placebo tablets.
19227|NCT02564029|O3|Outcome|Lorazepam 2 mg|One (1) lorazepam 2 mg tablet and seven (7) PF-06372865 placebo tablets.
19228|NCT02564029|O2|Outcome|PF-06372865 52.5 mg|One (1) lorazepam placebo tablet and seven (7) PF-06372865 7.5 mg tablets.
19229|NCT02564029|O1|Outcome|PF-06372865 17.5 mg|One (1) lorazepam placebo tablet and seven (7) PF-06372865 2.5 mg tablets.
19230|NCT02564029|E4|Reported Event|Lorazepam 2 mg|One (1) lorazepam 2 mg tablet and seven (7) PF-06372865 placebo tablets.
19231|NCT02564029|E3|Reported Event|PF-06372865 52.5 mg|One (1) lorazepam placebo tablet and seven (7) PF-06372865 7.5 mg tablets.
19232|NCT02564029|E2|Reported Event|PF-06372865 17.5 mg|One (1) lorazepam placebo tablet and seven (7) PF-06372865 2.5 mg tablets.
19233|NCT02564029|E1|Reported Event|Placebo|One (1) lorazepam placebo tablet and seven (7) PF-06372865 placebo tablets.
19234|NCT02563899|B5|Baseline|Total|Total of all reporting groups
19235|NCT02563899|B4|Baseline|LHH117157: Cohort B|A single dose of topically applied [14C] umeclidinium was administered to the occluded axilla. The dose to be administered was 165 mg of a 1.85% (w/w) solution umeclidinium (equivalent to a 2.2% umeclidinium bromide solution) applied to 40 (cm^2) surface area of occluded axilla (resulting in a calculated net amount of active umeclidinium of 3.06 mg).
19236|NCT02563899|B3|Baseline|AC4112008: GSK573719|Each participant received single dose of treatment in the following order of intravenous GSK573719 20 µg followed by oral GSK573719 1000 μg followed by intravenous GSK573719 50 µg, followed by inhaled GSK573719 1000 μg followed by intravenous GSK573719 65 µg in period 1, 2, 3, 4 and 5 respectively. The washout was of 5 days between two consecutive periods.
19237|NCT02563899|B2|Baseline|202093: Vehicle|Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
19238|NCT02563899|B1|Baseline|202093: Umeclidinium, 2 mg/cm^2 of 1.85%, OD|Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
19239|NCT02563899|P4|Participant Flow|LHH117157: Cohort B|A single dose of topically applied [14C] umeclidinium was administered to the occluded axilla. The dose to be administered was 165 mg of a 1.85% weight/ weight (w/w) solution umeclidinium (equivalent to a 2.2% umeclidinium bromide solution) applied to 40 centimeter squared (cm^2) surface area of occluded axilla (resulting in a calculated net amount of active umeclidinium of 3.06 mg).
19240|NCT02563899|P3|Participant Flow|AC4112008: GSK573719|Each participant received single dose of treatment in the following order of intravenous GSK573719 20 µg followed by oral GSK573719 1000 μg followed by intravenous GSK573719 50 µg, followed by inhaled GSK573719 1000 μg followed by intravenous GSK573719 65 µg in period 1, 2, 3, 4 and 5 respectively. The washout was of 5 days between two consecutive periods.
19241|NCT02563899|P2|Participant Flow|202093: Vehicle|Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
19242|NCT02563899|P1|Participant Flow|202093: Umeclidinium, 2 mg/cm^2 of 1.85%, OD|Participants topically applied Umeclidinium 2 milligram per square centimeter (mg/cm^2) of the 1.85%, administered once daily (OD) to both axillae, at night before going to bed for 14 days.
19243|NCT02563899|O2|Outcome|Vehicle|Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
19244|NCT02563899|O1|Outcome|Umeclidinium, 2 mg/cm^2 of 1.85%, OD|Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
19245|NCT02563899|O2|Outcome|Vehicle|Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
19246|NCT02563899|O1|Outcome|Umeclidinium, 2 mg/cm^2 of 1.85%, OD|Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
19247|NCT02563899|O2|Outcome|Vehicle|Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
19248|NCT02563899|O1|Outcome|Umeclidinium, 2 mg/cm^2 of 1.85%, OD|Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
19249|NCT02563899|O2|Outcome|Vehicle|Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
19250|NCT02563899|O1|Outcome|Umeclidinium, 2 mg/cm^2 of 1.85%, OD|Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
19251|NCT02563899|O2|Outcome|Vehicle|Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
19252|NCT02563899|O1|Outcome|Umeclidinium, 2 mg/cm^2 of 1.85%, OD|Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
19253|NCT02563899|O2|Outcome|Vehicle|Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
19254|NCT02563899|O1|Outcome|Umeclidinium, 2 mg/cm^2 of 1.85%, OD|Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
19255|NCT02563899|O2|Outcome|Vehicle|Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
19256|NCT02563899|O1|Outcome|Umeclidinium, 2 mg/cm^2 of 1.85%, OD|Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
19257|NCT02563899|O2|Outcome|Vehicle|Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
19258|NCT02563899|O1|Outcome|Umeclidinium, 2 mg/cm^2 of 1.85%, OD|Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
19259|NCT02563899|O2|Outcome|Vehicle|Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
19260|NCT02563899|O1|Outcome|Umeclidinium, 2 mg/cm^2 of 1.85%, OD|Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
19261|NCT02563899|O2|Outcome|Vehicle|Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
19262|NCT02563899|O1|Outcome|Umeclidinium, 2 mg/cm^2 of 1.85%, OD|Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
19263|NCT02563899|O4|Outcome|LHH117157: Cohort B|A single dose of topically applied [14C] umeclidinium administered to the occluded axilla. The dose to be administered was 165 mg of a 1.85% (w/w) solution Umeclidinium (equivalent to a 2.2% Umeclidinium bromide solution) applied to 40 (cm^2) surface area of occluded axilla (resulting in a calculated net amount of active Umeclidinium of 3.06 mg).
19264|NCT02563899|O3|Outcome|AC4112008: GSK573719|Each participants received single dose of treatment in the following order intravenous GSK573719 20 µg followed by oral GSK573719 1000 μg followed by intravenous GSK573719 50 µg, followed by inhaled GSK573719 1000 μg followed by intravenous GSK573719 65 µg in period 1, 2, 3, 4 and 5 respectively. The washout was of 5 days between two consecutive periods.
19265|NCT02563899|O2|Outcome|Vehicle|Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
19266|NCT02563899|O1|Outcome|Umeclidinium, 2 mg/cm^2 of 1.85%, OD|Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
19267|NCT02563899|O1|Outcome|Pooled Umeclidinium Population PK Arm|This arm is consisted of pooled PK populations from study 202093, AC4112008 and LHH117157. In the study 202093 participants topically applied Umeclidinium 2 mg/cm^2 of 1.85%, administered OD to both axillae, at night before going to bed for 14 days. In the study AC411200 each participant received single dose of treatment in the following of order intravenous GSK573719 20 µg followed by oral GSK573719 1000 μg followed by intravenous GSK573719 50 µg, followed by inhaled GSK573719 1000 μg followed by intravenous GSK573719 65 µg in period 1, 2, 3, 4 and 5 respectively. Washout was of 5 days between two consecutive periods. In the study LHH117157 a single dose of topically applied [14C] umeclidinium was administered to the occluded axilla. The dose to be administered was 165 mg of a 1.85% w/w solution umeclidinium (equivalent to a 2.2% umeclidinium bromide solution) applied to 40 cm^2 surface area of occluded axilla (resulting in a calculated net amount of active umeclidinium of 3.06 mg)
19268|NCT02563899|O1|Outcome|Pooled Umeclidinium Population PK Arm|This arm is consisted of pooled PK populations from study 202093, AC4112008 and LHH117157. In the study 202093 participants topically applied Umeclidinium 2 mg/cm^2 of 1.85%, administered OD to both axillae, at night before going to bed for 14 days. In the study AC411200 each participant received single dose of treatment in the following of order intravenous GSK573719 20 µg followed by oral GSK573719 1000 μg followed by intravenous GSK573719 50 µg, followed by inhaled GSK573719 1000 μg followed by intravenous GSK573719 65 µg in period 1, 2, 3, 4 and 5 respectively. Washout was of 5 days between two consecutive periods. In the study LHH117157 a single dose of topically applied [14C] umeclidinium was administered to the occluded axilla. The dose to be administered was 165 mg of a 1.85% w/w solution umeclidinium (equivalent to a 2.2% umeclidinium bromide solution) applied to 40 cm^2 surface area of occluded axilla (resulting in a calculated net amount of active umeclidinium of 3.06 mg)
19269|NCT02563899|O1|Outcome|Pooled Umeclidinium Population PK Arm|This arm is consisted of pooled PK populations from study 202093, AC4112008 and LHH117157. In the study 202093 participants topically applied Umeclidinium 2 mg/cm^2 of 1.85%, administered OD to both axillae, at night before going to bed for 14 days. In the study AC411200 each participant received single dose of treatment in the following of order intravenous GSK573719 20 µg followed by oral GSK573719 1000 μg followed by intravenous GSK573719 50 µg, followed by inhaled GSK573719 1000 μg followed by intravenous GSK573719 65 µg in period 1, 2, 3, 4 and 5 respectively. Washout was of 5 days between two consecutive periods. In the study LHH117157 a single dose of topically applied [14C] umeclidinium was administered to the occluded axilla. The dose to be administered was 165 mg of a 1.85% w/w solution umeclidinium (equivalent to a 2.2% umeclidinium bromide solution) applied to 40 cm^2 surface area of occluded axilla (resulting in a calculated net amount of active umeclidinium of 3.06 mg)
22283|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
19270|NCT02563899|O1|Outcome|Pooled Umeclidinium Population PK Arm|This arm is consisted of pooled PK populations from study 202093, AC4112008 and LHH117157. In the study 202093 participants topically applied Umeclidinium 2 mg/cm^2 of 1.85%, administered OD to both axillae, at night before going to bed for 14 days. In the study AC411200 each participant received single dose of treatment in the following of order intravenous GSK573719 20 µg followed by oral GSK573719 1000 μg followed by intravenous GSK573719 50 µg, followed by inhaled GSK573719 1000 μg followed by intravenous GSK573719 65 µg in period 1, 2, 3, 4 and 5 respectively. Washout was of 5 days between two consecutive periods. In the study LHH117157 a single dose of topically applied [14C] umeclidinium was administered to the occluded axilla. The dose to be administered was 165 mg of a 1.85% w/w solution umeclidinium (equivalent to a 2.2% umeclidinium bromide solution) applied to 40 cm^2 surface area of occluded axilla (resulting in a calculated net amount of active umeclidinium of 3.06 mg)
19271|NCT02563899|O1|Outcome|Pooled Umeclidinium Population PK Arm|This arm is consisted of pooled PK populations from study 202093, AC4112008 and LHH117157. In the study 202093 participants topically applied Umeclidinium 2 mg/cm^2 of 1.85%, administered OD to both axillae, at night before going to bed for 14 days. In the study AC411200 each participant received single dose of treatment in the following of order intravenous GSK573719 20 µg followed by oral GSK573719 1000 μg followed by intravenous GSK573719 50 µg, followed by inhaled GSK573719 1000 μg followed by intravenous GSK573719 65 µg in period 1, 2, 3, 4 and 5 respectively. Washout was of 5 days between two consecutive periods. In the study LHH117157 a single dose of topically applied [14C] umeclidinium was administered to the occluded axilla. The dose to be administered was 165 mg of a 1.85% w/w solution umeclidinium (equivalent to a 2.2% umeclidinium bromide solution) applied to 40 cm^2 surface area of occluded axilla (resulting in a calculated net amount of active umeclidinium of 3.06 mg)
19272|NCT02563899|O1|Outcome|Umeclidinium, 2 mg/cm^2 of 1.85%, OD|Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
19273|NCT02563899|O1|Outcome|Umeclidinium, 2 mg/cm^2 of 1.85%, OD|Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
19274|NCT02563899|O1|Outcome|Umeclidinium, 2 mg/cm^2 of 1.85%, OD|Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
19275|NCT02563899|O1|Outcome|Umeclidinium, 2 mg/cm^2 of 1.85%, OD|Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
19276|NCT02563899|O1|Outcome|Umeclidinium, 2 mg/cm^2 of 1.85%, OD|Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
19277|NCT02563899|O1|Outcome|Umeclidinium, 2 mg/cm^2 of 1.85%, OD|Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
19278|NCT02563899|E4|Reported Event|LHH117157: Cohort B|A single dose of topically applied [14C] umeclidinium administered to the occluded axilla. The dose to be administered was 165 mg of a 1.85% (w/w) solution umeclidinium (equivalent to a 2.2% umeclidinium bromide solution) applied to 40 (cm^2) surface area of occluded axilla (resulting in a calculated net amount of active umeclidinium of 3.06 mg).
19279|NCT02563899|E3|Reported Event|AC4112008: GSK573719|Each participants received single dose of treatment in the following order intravenous GSK573719 20 µg followed by oral GSK573719 1000 μg followed by intravenous GSK573719 50 µg, followed by inhaled GSK573719 1000 μg followed by intravenous GSK573719 65 µg in period 1, 2, 3, 4 and 5 respectively. The washout was of 5 days between two consecutive periods.
19280|NCT02563899|E2|Reported Event|202093:Vehicle|Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
19281|NCT02563899|E1|Reported Event|202093:Umeclidinium|Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
19282|NCT02563834|B3|Baseline|Total|Total of all reporting groups
19283|NCT02563834|B2|Baseline|Type 2 Diabetes|Participants with Type 2 diabetes treated with any combination of oral agents and insulin except PPARgamma agonists.
19284|NCT02563834|B1|Baseline|Lean Controls|Lean non-diabetic control participants, taking no regular medications.
19285|NCT02563834|P2|Participant Flow|Type 2 DM|"Studies will be performed on 2 separate days under fasting conditions, using a saline infusion on Day 1 and insulin infusion on Day 2. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate) on both study days.~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
19286|NCT02563834|P1|Participant Flow|Lean Control|"Studies will be performed on 2 separate days under fasting conditions, using a saline infusion on Day 1 and insulin infusion on Day 2. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate) on both study days.~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Saline: Saline infusion for control"
19287|NCT02563834|O4|Outcome|Type 2 DM - Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
19288|NCT02563834|O3|Outcome|Type 2 DM - Saline|"Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
19289|NCT02563834|O2|Outcome|Lean Control - Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Insulin: Insulin infusion for insulin/glucose clamp procedure"
19321|NCT02563093|O2|Outcome|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
22377|NCT02531698|B3|Baseline|Total|Total of all reporting groups
19290|NCT02563834|O1|Outcome|Lean Control - Saline|"Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Saline: Saline infusion for control"
19291|NCT02563834|O4|Outcome|Type 2 DM - Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
19292|NCT02563834|O3|Outcome|Type 2 DM - Saline|"Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
19293|NCT02563834|O2|Outcome|Lean Control - Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Insulin: Insulin infusion for insulin/glucose clamp procedure"
19294|NCT02563834|O1|Outcome|Lean Control - Saline|"Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Saline: Saline infusion for control"
19295|NCT02563834|O4|Outcome|Type 2 DM - Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
19296|NCT02563834|O3|Outcome|Type 2 DM - Saline|"Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
19297|NCT02563834|O2|Outcome|Lean Control - Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Insulin: Insulin infusion for insulin/glucose clamp procedure"
19298|NCT02563834|O1|Outcome|Lean Control - Saline|"Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Saline: Saline infusion for control"
19299|NCT02563834|E2|Reported Event|Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Insulin: Insulin infusion for insulin/glucose clamp procedure"
19300|NCT02563834|E1|Reported Event|Saline|"Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Saline: Saline infusion for control"
19301|NCT02563106|B3|Baseline|Total|Total of all reporting groups
19302|NCT02563106|B2|Baseline|Placebo|Matching Placebo
19303|NCT02563106|B1|Baseline|SYN-004|SYN-004 150 mg
19304|NCT02563106|P2|Participant Flow|Placebo|Placebo (no active drug)
19305|NCT02563106|P1|Participant Flow|SYN-004|SYN-004 150 mg
19306|NCT02563106|O2|Outcome|Placebo|Matching placebo
19307|NCT02563106|O1|Outcome|SYN-004|SYN-004 150 mg
19308|NCT02563106|E2|Reported Event|Placebo|Matching Placebo
19309|NCT02563106|E1|Reported Event|SYN-004|SYN-004 150 mg
19310|NCT02563093|B5|Baseline|Total|Total of all reporting groups
19311|NCT02563093|B4|Baseline|Fluzone High-Dose Vaccine|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
19312|NCT02563093|B3|Baseline|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
19313|NCT02563093|B2|Baseline|Fluzone Quadrivalent Intradermal Vaccine|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
19314|NCT02563093|B1|Baseline|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
19315|NCT02563093|P4|Participant Flow|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
19316|NCT02563093|P3|Participant Flow|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
19317|NCT02563093|P2|Participant Flow|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
19318|NCT02563093|P1|Participant Flow|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
19319|NCT02563093|O4|Outcome|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
19320|NCT02563093|O3|Outcome|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
19322|NCT02563093|O1|Outcome|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
19323|NCT02563093|O4|Outcome|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
19324|NCT02563093|O3|Outcome|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
19325|NCT02563093|O2|Outcome|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
19326|NCT02563093|O1|Outcome|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
19327|NCT02563093|O4|Outcome|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
19328|NCT02563093|O3|Outcome|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
19329|NCT02563093|O2|Outcome|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
19330|NCT02563093|O1|Outcome|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
19331|NCT02563093|O4|Outcome|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
19332|NCT02563093|O3|Outcome|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
19333|NCT02563093|O2|Outcome|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an Intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
19334|NCT02563093|O1|Outcome|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
19335|NCT02563093|O4|Outcome|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
19336|NCT02563093|O3|Outcome|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
19337|NCT02563093|O2|Outcome|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
19338|NCT02563093|O1|Outcome|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
19339|NCT02563093|E4|Reported Event|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
19340|NCT02563093|E3|Reported Event|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
19341|NCT02563093|E2|Reported Event|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
19342|NCT02563093|E1|Reported Event|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
19343|NCT02562521|B3|Baseline|Total|Total of all reporting groups
19344|NCT02562521|B2|Baseline|Control Site Participants|Dining hall employees who were current smokers were invited to participate in a treatment research study. Participants in the test and control sites received the same treatment components with a time delay where the control site started treatment 6 weeks after the test site.
19345|NCT02562521|B1|Baseline|Test Site Participants|Dining hall employees who were current smokers were invited to participate in a treatment research study. Participants in the test and control sites received the same treatment components with a time delay where the control site started treatment 6 weeks after the test site.
19346|NCT02562521|P2|Participant Flow|Control Site Participants|Dining hall employees who were current smokers were invited to participate in a treatment research study. Participants in the test and control sites received the same treatment components with a time delay where the control site started treatment 6 weeks after the test site.
19347|NCT02562521|P1|Participant Flow|Test Site Participants|Dining hall employees who were current smokers were invited to participate in a treatment research study. Participants in the test and control sites received the same treatment components with a time delay where the control site started treatment 6 weeks after the test site.
19348|NCT02562521|O1|Outcome|All Participants Enrolled in Treatment|All participants who enrolled in treatment in either the intervention condition or delayed treatment control were followed after treatment to determine smoking cessation outcomes.
19349|NCT02562521|O1|Outcome|All Participants Enrolled in Treatment|All participants who enrolled in treatment in either the intervention condition or delayed treatment control were followed after treatment to determine smoking cessation outcomes.
19350|NCT02562521|O1|Outcome|All Participants Enrolled in Treatment|All participants who enrolled in treatment in either the intervention condition or delayed treatment control were followed after treatment to determine smoking cessation outcomes.
19351|NCT02562521|O1|Outcome|All Participants Enrolled in Treatment|All participants who enrolled in treatment in either the intervention condition or delayed treatment control were followed after treatment to determine smoking cessation outcomes.
19352|NCT02562521|O1|Outcome|All Participants Enrolled in Treatment|All participants who enrolled in treatment in either the intervention condition or delayed treatment control were followed after treatment to determine smoking cessation outcomes.
19353|NCT02562521|O1|Outcome|All Participants Enrolled in Treatment|All participants who enrolled in treatment in either the intervention condition or delayed treatment control were followed after treatment to determine smoking cessation outcomes.
19739|NCT02558829|O1|Outcome|Insulin Tolerance Test (ITT), All Groups, SAF Population|All subjects of Group A, B, C, and D with at least one ITT performed: N=157
19354|NCT02562521|O1|Outcome|All Participants Enrolled in Treatment|All participants who enrolled in treatment in either the intervention condition or delayed treatment control were followed after treatment to determine smoking cessation outcomes.
19355|NCT02562521|O2|Outcome|Delayed Treatment Control|Participants in this arm will be offered the Smoking Cessation Treatment 6 weeks later
19356|NCT02562521|O1|Outcome|Smoking Cessation Treatment|"The intervention will consist of Contingency management (CM) in conjunction with effective first line pharmacotherapy (dual nicotine replacement therapy [NRT] or varenicline) and brief counseling to rapidly induce cessation and to maintain abstinence long term. Pharmacotherapy will be flexible. Participants will also be given the option of receiving additional behavioral support by being referred to the CT Quitline and using text or mobile phone apps for quitting.~Contingency management: Participants in the intervention group will receive a tailored intervention that utilizes contingency management in which they receive monetary rewards for reducing or quitting smoking.~Nicotine replacement therapy: Participants have the option of using nicotine patch in combination with nicotine gum or lozenge~Varenicline: Individuals who do not respond initially to Nicotine Replacement Therapy will be offered varenicline as an alternative~Additional behavioral support: Based on interest,"
19357|NCT02562521|O2|Outcome|Delayed Treatment Control|Participants in this arm will be offered the Smoking Cessation Treatment 6 weeks later
19358|NCT02562521|O1|Outcome|Smoking Cessation Treatment|"The intervention will consist of Contingency management (CM) in conjunction with effective first line pharmacotherapy (dual nicotine replacement therapy [NRT] or varenicline) and brief counseling to rapidly induce cessation and to maintain abstinence long term. Pharmacotherapy will be flexible. Participants will also be given the option of receiving additional behavioral support by being referred to the CT Quitline and using text or mobile phone apps for quitting.~Contingency management: Participants in the intervention group will receive a tailored intervention that utilizes contingency management in which they receive monetary rewards for reducing or quitting smoking.~Nicotine replacement therapy: Participants have the option of using nicotine patch in combination with nicotine gum or lozenge~Varenicline: Individuals who do not respond initially to Nicotine Replacement Therapy will be offered varenicline as an alternative~Additional behavioral support: Based on interest,"
19359|NCT02562521|E1|Reported Event|All Participants Who Enrolled in Treatment|All participants who enrolled in treatment in either the intervention condition or delayed treatment control were followed after treatment to determine smoking cessation and adverse event outcomes because all participants ultimately received the same treatment components.
19360|NCT02561806|B3|Baseline|Total|Total of all reporting groups
19361|NCT02561806|B2|Baseline|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
19362|NCT02561806|B1|Baseline|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
19363|NCT02561806|P2|Participant Flow|Ixekizumab|160 mg ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
19364|NCT02561806|P1|Participant Flow|Ustekinumab|45 milligram (mg) ustekinumab given as Subcutaneous (SC) injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
19365|NCT02561806|O2|Outcome|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
19366|NCT02561806|O1|Outcome|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
19367|NCT02561806|O2|Outcome|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
19368|NCT02561806|O1|Outcome|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding
19369|NCT02561806|O2|Outcome|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
19370|NCT02561806|O1|Outcome|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
19371|NCT02561806|O2|Outcome|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
19372|NCT02561806|O1|Outcome|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
19373|NCT02561806|O2|Outcome|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
19740|NCT02558829|O4|Outcome|Negative MAC, Negative ITT|Test outcome negative for MAC and for ITT
19374|NCT02561806|O1|Outcome|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
19375|NCT02561806|O2|Outcome|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
19376|NCT02561806|O1|Outcome|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
19377|NCT02561806|O2|Outcome|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
19378|NCT02561806|O1|Outcome|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
19379|NCT02561806|O2|Outcome|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
19380|NCT02561806|O1|Outcome|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
19381|NCT02561806|O2|Outcome|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
19382|NCT02561806|O1|Outcome|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
19383|NCT02561806|O2|Outcome|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
19384|NCT02561806|O1|Outcome|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
19385|NCT02561806|O2|Outcome|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
19386|NCT02561806|O1|Outcome|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
19387|NCT02561806|O2|Outcome|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
19388|NCT02561806|O1|Outcome|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
19389|NCT02561806|O2|Outcome|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
19390|NCT02561806|O1|Outcome|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
19391|NCT02561806|O2|Outcome|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
19392|NCT02561806|O1|Outcome|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
19393|NCT02561806|O2|Outcome|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
19394|NCT02561806|O1|Outcome|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
19395|NCT02561806|O2|Outcome|Ixekizumab|"160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.~Ixekizumab: Administered SC"
19396|NCT02561806|O1|Outcome|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
19397|NCT02561806|O2|Outcome|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
19398|NCT02561806|O1|Outcome|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
19399|NCT02561806|O2|Outcome|Ixekizumab|"160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.~Ixekizumab: Administered SC"
19400|NCT02561806|O1|Outcome|Ustekinumab|"45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.~Ustekinumab: Administered SC"
19401|NCT02561806|O2|Outcome|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
19402|NCT02561806|O1|Outcome|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
19403|NCT02561806|O2|Outcome|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
19404|NCT02561806|O1|Outcome|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
19405|NCT02561806|O2|Outcome|Ixekizumab|"160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.~Ixekizumab: Administered SC"
19406|NCT02561806|O1|Outcome|Ustekinumab|"45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.~Ustekinumab: Administered SC"
19407|NCT02561806|O2|Outcome|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
19408|NCT02561806|O1|Outcome|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
19409|NCT02561806|O2|Outcome|Ixekizumab|"160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.~Ixekizumab: Administered SC"
19410|NCT02561806|O1|Outcome|Ustekinumab|"45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.~Ustekinumab: Administered SC"
19411|NCT02561806|O2|Outcome|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
19412|NCT02561806|O1|Outcome|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
19413|NCT02561806|E2|Reported Event|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
19414|NCT02561806|E1|Reported Event|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
19415|NCT02561702|B1|Baseline|All Participants|
19416|NCT02561702|P2|Participant Flow|Placebo First/Mexiletine Second|"Participants will receive placebo (240 mg of lactose powder) taken by mouth 3 times daily for 5-7 days followed by 7 day washout period and 5-7 days of 150 mg of mexiletine by mouth 3 times daily~Placebo: 240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days~Mexiletine: 150 mg Mexiletine taken by mouth in capsule form 3 times daily for 5-7 days"
19417|NCT02561702|P1|Participant Flow|Mexiletine First/Placebo Second|"Participants will receive 150 mg of mexiletine by mouth 3 times daily for 5-7 days followed by 7 day washout period and 5-7 days of placebo (240 mg of lactose powder) taken by mouth 3 times daily~Placebo: 240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days~Mexiletine: 150 mg Mexiletine taken by mouth in capsule form 3 times daily for 5-7 days"
19418|NCT02561702|O2|Outcome|Placebo|"Participants will receive placebo (240 mg of lactose powder) taken by mouth 3 times daily for 5-7 days followed by 7 day washout period and 5-7 days of 150 mg of mexiletine by mouth 3 times daily~Placebo: 240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days~Mexiletine: 150 mg Mexiletine taken by mouth in capsule form 3 times daily for 5-7 days"
22643|NCT02531373|B10|Baseline|Total|Total of all reporting groups
19419|NCT02561702|O1|Outcome|Mexiletine|"Participants will receive 150 mg of mexiletine by mouth 3 times daily for 5-7 days followed by 7 day washout period and 5-7 days of placebo (240 mg of lactose powder) taken by mouth 3 times daily~Placebo: 240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days~Mexiletine: 150 mg Mexiletine taken by mouth in capsule form 3 times daily for 5-7 days"
19420|NCT02561702|O2|Outcome|Placebo|"Participants will receive placebo (240 mg of lactose powder) taken by mouth 3 times daily for 5-7 days followed by 7 day washout period and 5-7 days of 150 mg of mexiletine by mouth 3 times daily~Placebo: 240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days~Mexiletine: 150 mg Mexiletine taken by mouth in capsule form 3 times daily for 5-7 days"
19421|NCT02561702|O1|Outcome|Mexiletine|"Participants will receive 150 mg of mexiletine by mouth 3 times daily for 5-7 days followed by 7 day washout period and 5-7 days of placebo (240 mg of lactose powder) taken by mouth 3 times daily~Placebo: 240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days~Mexiletine: 150 mg Mexiletine taken by mouth in capsule form 3 times daily for 5-7 days"
19422|NCT02561702|E2|Reported Event|Placebo|"Participants will receive placebo (240 mg of lactose powder) taken by mouth 3 times daily for 5-7 days followed by 7 day washout period and 5-7 days of 150 mg of mexiletine by mouth 3 times daily~Placebo: 240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days~Mexiletine: 150 mg Mexiletine taken by mouth in capsule form 3 times daily for 5-7 days"
19423|NCT02561702|E1|Reported Event|Mexiletine|"Participants will receive 150 mg of mexiletine by mouth 3 times daily for 5-7 days followed by 7 day washout period and 5-7 days of placebo (240 mg of lactose powder) taken by mouth 3 times daily~Placebo: 240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days~Mexiletine: 150 mg Mexiletine taken by mouth in capsule form 3 times daily for 5-7 days"
19424|NCT02561572|B3|Baseline|Total|Total of all reporting groups
19425|NCT02561572|B2|Baseline|Control|No intervention for 30 minutes.
19426|NCT02561572|B1|Baseline|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
19427|NCT02561572|P2|Participant Flow|Control|No intervention for 30 minutes.
19428|NCT02561572|P1|Participant Flow|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
19429|NCT02561572|O2|Outcome|Control|No intervention for 30 minutes.
19430|NCT02561572|O1|Outcome|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
19431|NCT02561572|O2|Outcome|Control|No intervention for 30 minutes.
19432|NCT02561572|O1|Outcome|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
19433|NCT02561572|O2|Outcome|Control|No intervention for 30 minutes.
19434|NCT02561572|O1|Outcome|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
19435|NCT02561572|O2|Outcome|Control|No intervention for 30 minutes.
19436|NCT02561572|O1|Outcome|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
19437|NCT02561572|O2|Outcome|Control|No intervention for 30 minutes.
19438|NCT02561572|O1|Outcome|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
19439|NCT02561572|O2|Outcome|Control|No intervention for 30 minutes.
19440|NCT02561572|O1|Outcome|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
19441|NCT02561572|E2|Reported Event|Control|No intervention for 30 minutes.
19442|NCT02561572|E1|Reported Event|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
19443|NCT02561195|B7|Baseline|Total|Total of all reporting groups
19444|NCT02561195|B6|Baseline|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19445|NCT02561195|B5|Baseline|Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19446|NCT02561195|B4|Baseline|Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
19447|NCT02561195|B3|Baseline|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19448|NCT02561195|B2|Baseline|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19449|NCT02561195|B1|Baseline|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination
19450|NCT02561195|P6|Participant Flow|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19451|NCT02561195|P5|Participant Flow|Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19452|NCT02561195|P4|Participant Flow|Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
19453|NCT02561195|P3|Participant Flow|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19454|NCT02561195|P2|Participant Flow|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
24801|NCT02498652|O5|Outcome|Treatment R4|Allopurinol 300 mg qd + RDEA3170 10 mg qd
19455|NCT02561195|P1|Participant Flow|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 microgram (mcg) of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19456|NCT02561195|O1|Outcome|Extension Stage Endpoint|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.
19457|NCT02561195|O1|Outcome|Extension Stage Endpoint|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.
19458|NCT02561195|O1|Outcome|Extension Stage Endpoint|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.
19459|NCT02561195|O1|Outcome|Extension Stage Endpoint|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.
19460|NCT02561195|O1|Outcome|Extension Stage Endpoint|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.
19461|NCT02561195|O1|Outcome|Extension Stage Endpoint|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.
19462|NCT02561195|O1|Outcome|Extension Stage Endpoint|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.
19463|NCT02561195|O1|Outcome|Extension Stage Endpoint|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.
19464|NCT02561195|O1|Outcome|Extension Stage Endpoint|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.
19465|NCT02561195|O1|Outcome|Extension Stage Endpoint|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.
19466|NCT02561195|O1|Outcome|Extension Stage Endpoint|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.
19467|NCT02561195|O1|Outcome|Extension Stage Endpoint|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.
19468|NCT02561195|O1|Outcome|Extension Stage Endpoint|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.
19469|NCT02561195|O1|Outcome|Extension Stage Endpoint|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.
19470|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19471|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
19472|NCT02561195|O1|Outcome|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19473|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19474|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
19475|NCT02561195|O1|Outcome|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19476|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19477|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
19478|NCT02561195|O1|Outcome|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19479|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
33125|NCT02423447|E1|Reported Event|Electro Flo|Electro flo
19480|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination
19481|NCT02561195|O1|Outcome|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19482|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19483|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination
19484|NCT02561195|O1|Outcome|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19485|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19486|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination
19487|NCT02561195|O1|Outcome|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19488|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19489|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
19490|NCT02561195|O1|Outcome|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19491|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19492|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
19493|NCT02561195|O1|Outcome|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19494|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19495|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination
19496|NCT02561195|O1|Outcome|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19497|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19498|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination
19499|NCT02561195|O1|Outcome|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19500|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19501|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
19502|NCT02561195|O1|Outcome|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19503|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19504|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
19505|NCT02561195|O1|Outcome|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19506|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19507|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination
19508|NCT02561195|O1|Outcome|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19509|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19510|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination
19511|NCT02561195|O1|Outcome|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19512|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19513|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
19514|NCT02561195|O1|Outcome|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19515|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19516|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
19517|NCT02561195|O1|Outcome|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19518|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19519|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
19520|NCT02561195|O1|Outcome|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19521|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19522|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination
19523|NCT02561195|O1|Outcome|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19524|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19525|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination
19526|NCT02561195|O1|Outcome|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19527|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19528|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination
19529|NCT02561195|O1|Outcome|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19530|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19531|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
19532|NCT02561195|O1|Outcome|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19533|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19534|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination
19535|NCT02561195|O1|Outcome|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
24802|NCT02498652|O4|Outcome|Treatment R2|Allopurinol 300 mg qd + RDEA3170 5 mg qd
19536|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19537|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
19538|NCT02561195|O1|Outcome|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19539|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19540|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination
19541|NCT02561195|O1|Outcome|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19542|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19543|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
19544|NCT02561195|O1|Outcome|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19545|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19546|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination
19547|NCT02561195|O1|Outcome|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19548|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19549|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
19550|NCT02561195|O1|Outcome|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19551|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19552|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination
19553|NCT02561195|O1|Outcome|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19554|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19555|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
19556|NCT02561195|O1|Outcome|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19557|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19558|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination
19559|NCT02561195|O1|Outcome|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19560|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19561|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
19562|NCT02561195|O1|Outcome|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19563|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19564|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination
19565|NCT02561195|O1|Outcome|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19566|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19567|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
19568|NCT02561195|O1|Outcome|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19569|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19570|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination
19571|NCT02561195|O1|Outcome|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19572|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19573|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
19574|NCT02561195|O1|Outcome|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19575|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19576|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination
19577|NCT02561195|O1|Outcome|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19578|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19579|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
19580|NCT02561195|O1|Outcome|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19581|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19582|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination
19583|NCT02561195|O1|Outcome|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19584|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19585|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
19586|NCT02561195|O1|Outcome|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19587|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19588|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination
19589|NCT02561195|O1|Outcome|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19590|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19591|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
19592|NCT02561195|O1|Outcome|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19593|NCT02561195|O3|Outcome|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19594|NCT02561195|O2|Outcome|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination
19595|NCT02561195|O1|Outcome|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19596|NCT02561195|E6|Reported Event|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19597|NCT02561195|E5|Reported Event|Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
19598|NCT02561195|E4|Reported Event|Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
19599|NCT02561195|E3|Reported Event|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19600|NCT02561195|E2|Reported Event|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
19601|NCT02561195|E1|Reported Event|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination
19602|NCT02559622|B5|Baseline|Total|Total of all reporting groups
19603|NCT02559622|B4|Baseline|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19604|NCT02559622|B3|Baseline|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19605|NCT02559622|B2|Baseline|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19606|NCT02559622|B1|Baseline|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19607|NCT02559622|P4|Participant Flow|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19608|NCT02559622|P3|Participant Flow|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19609|NCT02559622|P2|Participant Flow|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19610|NCT02559622|P1|Participant Flow|Secukinumab 300 mg|Participants were administered with 300 milligrams (mg) secukinumab subcutaneously (s.c.) using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19611|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19612|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19613|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19614|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19615|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19616|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19617|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19618|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19619|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19620|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19621|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19622|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19623|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19624|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19625|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19626|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19627|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19628|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19629|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19630|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19631|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19632|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19633|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19634|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19635|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19636|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19637|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19638|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19639|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19640|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19641|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19642|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19643|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19644|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19645|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19646|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19741|NCT02558829|O3|Outcome|Negative MAC, Positive ITT|Test outcome negative for MAC and positive for ITT
19647|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19648|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19649|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19650|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19651|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19652|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19653|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19654|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19655|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19656|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19657|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19658|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19659|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19660|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19661|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19662|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19663|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19664|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19665|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19666|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19667|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19668|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19669|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19670|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19671|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19672|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19673|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
20002|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
19674|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19675|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19676|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19677|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19678|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19679|NCT02559622|O2|Outcome|Placebo (Pooled)|Participants were administered with placebo until week 12 followed by 150 mg or 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg or 300 mg secukinumab respectively every 4 weeks until week 48 (last injection).
19680|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19681|NCT02559622|E7|Reported Event|Placebo Followed by Secukinumab (150 mg) After Week 12|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using prefilled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19682|NCT02559622|E6|Reported Event|Placebo Followed by Secukinumab (300 mg) After Week 12|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using prefilled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19683|NCT02559622|E5|Reported Event|Secukinumab (150 mg) After Week 12|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
19684|NCT02559622|E4|Reported Event|Secukinumab (300 mg) After Week 12|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
19685|NCT02559622|E3|Reported Event|Placebo up to Week 12|Participants were administered with placebo up to 12 weeks.
19686|NCT02559622|E2|Reported Event|Secukinumab (150 mg) up to Week 12|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab up to 12 weeks.
19687|NCT02559622|E1|Reported Event|Secukinumab (300 mg) up to Week 12|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab up to 12 weeks.
19688|NCT02559414|B4|Baseline|Total|Total of all reporting groups
19689|NCT02559414|B3|Baseline|Clopidogrel|"This arm of 20 subjects will be assigned randomly via a computer generated treatment sequence, and then be given clopidogrel.~Clopidogrel"
19690|NCT02559414|B2|Baseline|Aspirin|"This arm of 20 subjects will be assigned randomly via a computer generated treatment sequence, and then be given aspirin.~Aspirin"
19691|NCT02559414|B1|Baseline|Control|This arm of 10 subjects will be assigned randomly via a computer generated treatment sequence, and then be given no antiplatelet medication.
19692|NCT02559414|P3|Participant Flow|Clopidogrel|"This arm of 20 subjects will be assigned randomly via a computer generated treatment sequence, and then be given clopidogrel.~Clopidogrel"
19693|NCT02559414|P2|Participant Flow|Aspirin|"This arm of 20 subjects will be assigned randomly via a computer generated treatment sequence, and then be given aspirin.~Aspirin"
19694|NCT02559414|P1|Participant Flow|Control|This arm of 10 subjects will be assigned randomly via a computer generated treatment sequence, and then be given no antiplatelet medication.
19695|NCT02559414|O6|Outcome|Clopidogrel Randomization|
19696|NCT02559414|O5|Outcome|Clopidogrel Baseline|
19697|NCT02559414|O4|Outcome|Aspirin Randomization|
19698|NCT02559414|O3|Outcome|Aspirin Baseline|
19699|NCT02559414|O2|Outcome|Placebo Follow up|
19700|NCT02559414|O1|Outcome|Placebo Baseline|This arm of 10 subjects will be assigned randomly via a computer generated treatment sequence, and then be given no antiplatelet medication.
19701|NCT02559414|O6|Outcome|Clopidogrel Randomization|
19702|NCT02559414|O5|Outcome|Clopidogrel Baseline|
19703|NCT02559414|O4|Outcome|Aspirin Randomization|
19704|NCT02559414|O3|Outcome|Aspirin Baseline|
19705|NCT02559414|O2|Outcome|Placebo Follow up|
19706|NCT02559414|O1|Outcome|Placebo Baseline|This arm of 10 subjects will be assigned randomly via a computer generated treatment sequence, and then be given no antiplatelet medication.
19707|NCT02559414|E6|Reported Event|Clopidogrel Randomization|
19708|NCT02559414|E5|Reported Event|Clopidogrel Baseline|
19709|NCT02559414|E4|Reported Event|Aspirin Randomization|
19710|NCT02559414|E3|Reported Event|Aspirin Baseline|
19711|NCT02559414|E2|Reported Event|Placebo Follow up|
19712|NCT02559414|E1|Reported Event|Placebo Baseline|This arm of 10 subjects will be assigned randomly via a computer generated treatment sequence, and then be given no antiplatelet medication.
19713|NCT02558829|B5|Baseline|Total|Total of all reporting groups
19714|NCT02558829|B4|Baseline|Group D|Healthy control. Healthy subjects matching Group A subjects by sex, age, body mass index (BMI), and estrogen status (females only).
19715|NCT02558829|B3|Baseline|Group C|"Low likelihood of GHD:~One risk factor for GHD only, such as history of distant traumatic brain injury (TBI) or one PHD only with otherwise normal pituitary function or~Isolated idiopathic childhood onset GHD without additional pituitary deficits"
19716|NCT02558829|B2|Baseline|Group B|"Intermediate likelihood of GHD:~• Eligible subjects not qualifying for either high or low likelihood (Group A/C)"
19717|NCT02558829|B1|Baseline|Group A|"High likelihood of growth hormone deficiency (GHD):~Structural hypothalamic or pituitary lesions and low insulin-like growth factor 1 (IGF-1), and/or~Three or more pituitary hormone deficiencies (PHD) and low IGF-1, or~Childhood onset GHD with structural lesions and low IGF-1."
19718|NCT02558829|P8|Participant Flow|Group D Test Sequence ITT-MAC|"Group D: Healthy control. Healthy subjects matching Group A subjects by sex, age, BMI, and estrogen status (females only).~Randomization of GHST administration to following test sequence:~1st Insulin Tolerance Test (ITT), 2nd Macimorelin-GHST (MAC)~Insulin Tolerance Test: administration of regular human insulin, 0.10 U/kg (0.15 U/kg if BMI > 30 kg/m2), intravenous injection, single dose.~Macimorelin GHST: administration of macimorelin acetate, 0.5 mg/kg body weight, drinking solution, single dose."
19719|NCT02558829|P7|Participant Flow|Group D Test Sequence MAC-ITT|"Group D: Healthy control. Healthy subjects matching Group A subjects by sex, age, BMI, and estrogen status (females only).~Randomization of GHST administration to following test sequence:~1st Macimorelin-GHST (MAC), 2nd Insulin Tolerance Test (ITT).~Macimorelin GHST: administration of macimorelin acetate, 0.5 mg/kg body weight, drinking solution, single dose.~Insulin Tolerance Test: administration of regular human insulin, 0.10 U/kg (0.15 U/kg if BMI > 30 kg/m2), intravenous injection, single dose."
19720|NCT02558829|P6|Participant Flow|Group C Test Sequence ITT-MAC|"Group C: Low likelihood of GHD~one risk factor for GHD only, such as history of distant traumatic brain injury (TBI) or one PHD only with otherwise normal pituitary function or~isolated idiopathic childhood onset GHD without additional pituitary deficits.~Randomization of GHST administration to following test sequence:~1st Insulin Tolerance Test (ITT), 2nd Macimorelin-GHST (MAC)~Insulin Tolerance Test: administration of regular human insulin, 0.10 U/kg (0.15 U/kg if BMI > 30 kg/m2), intravenous injection, single dose.~Macimorelin GHST: administration of macimorelin acetate, 0.5 mg/kg body weight, drinking solution, single dose."
19721|NCT02558829|P5|Participant Flow|Group C Test Sequence MAC-ITT|"Group C: Low likelihood of GHD~one risk factor for GHD only, such as history of distant traumatic brain injury (TBI) or one PHD only with otherwise normal pituitary function or~isolated idiopathic childhood onset GHD without additional pituitary deficits.~Randomization of GHST administration to following test sequence:~1st Macimorelin-GHST (MAC), 2nd Insulin Tolerance Test (ITT).~Macimorelin GHST: administration of macimorelin acetate, 0.5 mg/kg body weight, drinking solution, single dose.~Insulin Tolerance Test: administration of regular human insulin, 0.10 U/kg (0.15 U/kg if BMI > 30 kg/m2), intravenous injection, single dose."
19722|NCT02558829|P4|Participant Flow|Group B Test Sequence ITT- MAC|"Group B: intermediate likelihood of GHD:~- eligible subjects not qualifying for either high or low likelihood (Group A/C)~Randomization of GHST administration to following test sequence:~1st Insulin Tolerance Test (ITT), 2nd Macimorelin-GHST (MAC)~Insulin Tolerance Test: administration of regular human insulin, 0.10 U/kg (0.15 U/kg if BMI > 30 kg/m2), intravenous injection, single dose.~Macimorelin GHST: administration of macimorelin acetate, 0.5 mg/kg body weight, drinking solution, single dose."
19723|NCT02558829|P3|Participant Flow|Group B Test Sequence MAC-ITT|"Group B: intermediate likelihood of GHD:~- eligible subjects not qualifying for either high or low likelihood (Group A/C)~Randomization of GHST administration to following test sequence:~1st Macimorelin-GHST (MAC), 2nd Insulin Tolerance Test (ITT).~Macimorelin GHST: administration of macimorelin acetate, 0.5 mg/kg body weight, drinking solution, single dose.~Insulin Tolerance Test: administration of regular human insulin, 0.10 U/kg (0.15 U/kg if BMI > 30 kg/m2), intravenous injection, single dose."
19724|NCT02558829|P2|Participant Flow|Group A Test Sequence ITT-MAC|"Group A: High likelihood of GHD:~structural hypothalamic or pituitary lesions and low IGF-1, and/or - three or more pituitary hormone deficiencies (PHD) and low IGF-1, or~childhood onset GHD with structural lesions and low IGF-1~Randomization of GHST administration to following test sequence:~1st Insulin Tolerance Test (ITT), 2nd Macimorelin-GHST (MAC)~Insulin Tolerance Test: administration of regular human insulin, 0.10 U/kg (0.15 U/kg if BMI > 30 kg/m2), intravenous injection, single dose.~Macimorelin GHST: administration of macimorelin acetate, 0.5 mg/kg body weight, drinking solution, single dose."
19725|NCT02558829|P1|Participant Flow|Group A Test Sequence MAC-ITT|"Group A: High likelihood of GHD:~structural hypothalamic or pituitary lesions and low IGF-1, and/or - three or more pituitary hormone deficiencies (PHD) and low IGF-1, or~childhood onset GHD with structural lesions and low IGF-1.~Randomization of GHST administration to following test sequence:~1st Macimorelin-GHST (MAC), 2nd Insulin Tolerance Test (ITT).~Macimorelin GHST: administration of macimorelin acetate, 0.5 mg/kg body weight, drinking solution, single dose.~Insulin Tolerance Test: administration of regular human insulin, 0.10 U/kg (0.15 U/kg if BMI > 30 kg/m2), intravenous injection, single dose."
19726|NCT02558829|O4|Outcome|Negative MAC Core, Positive MAC Repeatability|Test outcome negative for MAC in core study part and positive for MAC in the repeatability extension.
19727|NCT02558829|O3|Outcome|Negative MAC Core, Negative MAC Repeatability|Test outcome negative for MAC in core study part and negative for MAC in the repeatability extension.
19728|NCT02558829|O2|Outcome|Positive MAC Core, Negative MAC Repeatability|Test outcome positive for MAC in core study part and negative for MAC in the repeatability extension.
19729|NCT02558829|O1|Outcome|Positive MAC Core, Positive MAC Repeatability|Test outcome positive for MAC in core study part and positive for MAC in the repeatability extension.
19730|NCT02558829|O4|Outcome|Negative MAC, Group D|Negative test outcome of the MAC in subjects of Group D (healthy matched controls)
19731|NCT02558829|O3|Outcome|Negative MAC, Group A|Negative test outcome of the MAC in subjects of AGHD likelihood group A (high likelihood)
19732|NCT02558829|O2|Outcome|Positive MAC, Group D|positive test outcome of the MAC in subjects of Group D (healthy matched controls)
19733|NCT02558829|O1|Outcome|Positive MAC, Group A|Positive test outcome of the MAC in subjects of AGHD likelihood group A (high likelihood)
19734|NCT02558829|O4|Outcome|ITT, HR at Post-dose|Insulin Tolerance Test, HR value at test/time point 60 minutes post-dose.
19735|NCT02558829|O3|Outcome|ITT, HR at Pre-dose|Insulin Tolerance Test, HR value at test/time point pre-dose.
19736|NCT02558829|O2|Outcome|MAC, HR at Post-dose|Macimorelin GHST, HR value at test/time point 60 minutes post-dose.
19737|NCT02558829|O1|Outcome|MAC, Heart Rate at Pre-dose|Macimorelin GHST, heart rate (HR) value at test/time point pre-dose.
19738|NCT02558829|O2|Outcome|Macimorelin GHST (MAC), All Groups, SAF Population|All subjects of Group A, B, C, and D with at least one macimorelin GHST: N=154 (three subjects were not exposed to MAC but were exposed to ITT only).
20003|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
19742|NCT02558829|O2|Outcome|Positive MAC, Negative ITT|Test outcome positive for MAC and negative for ITT
19743|NCT02558829|O1|Outcome|Positive MAC, Positive ITT|Test outcome positive for MAC and for ITT
19744|NCT02558829|O4|Outcome|Negative MAC, Negative ITT|Test outcome negative for MAC and for ITT
19745|NCT02558829|O3|Outcome|Negative MAC, Positive ITT|Test outcome negative for MAC and positive for ITT
19746|NCT02558829|O2|Outcome|Positive MAC, Negative ITT|Test outcome positive for MAC and negative for ITT
19747|NCT02558829|O1|Outcome|Positive MAC, Positive ITT|Test outcome positive for MAC and for ITT
19748|NCT02558829|E2|Reported Event|Insulin Tolerance Test (ITT), SAF Population|Insulin Tolerance Test (ITT) All subjects of Group A, B, C, D with at least one ITT performed: N=157. All subjects of Group A, B, C, D valid for safety (SAF) analysis: N=157.
19749|NCT02558829|E1|Reported Event|Macimorelin GHST (MAC), SAF Population|"Macimorelin GHST (MAC): combined safety data from core study and repeatability extension (Amendment 1, European sites only)).~All subjects of Group A, B, C, D with at least one macimorelin GHST performed: N=154.~All subjects of Group A, B, C, D valid for safety (SAF) analysis: N=157. (three subjects were exposed to the ITT only).~Repeatability extension (planned repetition of the MAC): subjects of Group A, B, C valid for safety (SAF)analysis: N=34."
19750|NCT02558790|B1|Baseline|L-Threonic Acid Magnesium Salt (L-TAMS)|Subjects received open label L-Threonic acid Magnesium salt for 12 weeks. Subjects took MMFS202 (6-hour release) and MMFS302 (12-hour release) by mouth each day, up to three times a day.
19751|NCT02558790|P1|Participant Flow|L-Threonic Acid Magnesium Salt (L-TAMS)|Subjects took open label L-Threonic acid Magnesium salt for 12 weeks. Subjects took MMFS202 (6-hour release) and MMFS302 (12-hour release) by mouth each day, up to three times a day.
19752|NCT02558790|O1|Outcome|L-Threonic Acid Magnesium Salt (L-TAMS)|Subjects took open label L-Threonic acid Magnesium salt for 12 weeks. Subjects took MMFS202 (6-hour release) and MMFS302 (12-hour release) by mouth each day, up to three times a day.
19753|NCT02558790|E1|Reported Event|L-Threonic Acid Magnesium Salt (L-TAMS)|Subjects received open label L-Threonic acid Magnesium salt for 12 weeks. Subjects took MMFS202 (6-hour release) and MMFS302 (12-hour release) by mouth each day, up to three times a day.
19754|NCT02558374|B3|Baseline|Total|Total of all reporting groups
19755|NCT02558374|B2|Baseline|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
19756|NCT02558374|B1|Baseline|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) and 1 drop placebo in the morning (AM) in both eyes (OU)
19757|NCT02558374|P2|Participant Flow|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
19758|NCT02558374|P1|Participant Flow|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
19759|NCT02558374|O2|Outcome|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
19760|NCT02558374|O1|Outcome|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
19761|NCT02558374|O2|Outcome|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
19762|NCT02558374|O1|Outcome|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
19763|NCT02558374|E2|Reported Event|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
19764|NCT02558374|E1|Reported Event|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
19765|NCT02557698|B3|Baseline|Total|Total of all reporting groups
19766|NCT02557698|B2|Baseline|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19767|NCT02557698|B1|Baseline|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19768|NCT02557698|P2|Participant Flow|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19769|NCT02557698|P1|Participant Flow|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19770|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19771|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19772|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19773|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19774|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19775|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19776|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19777|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19778|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19779|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19780|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19781|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19782|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19783|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19784|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19785|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19786|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19787|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19788|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19789|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19790|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19791|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19792|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19793|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19794|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19795|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19796|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19797|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19798|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19799|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19800|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19801|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19802|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19803|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19804|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19805|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19806|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19807|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19808|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19809|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19810|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19811|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19812|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19813|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19814|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19815|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19816|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19817|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19818|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19819|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19820|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19821|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19822|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19823|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19824|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19825|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19826|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19827|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19828|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19829|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19830|NCT02557698|E2|Reported Event|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
19831|NCT02557698|E1|Reported Event|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
19832|NCT02557646|B1|Baseline|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
20004|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
20005|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
20006|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
19833|NCT02557646|P1|Participant Flow|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a (Pegasys) and ribavirin (Copegus) in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
19834|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
19835|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
19836|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
19837|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
19838|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
19839|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
19840|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
19841|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
19842|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
19843|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
19844|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
19845|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
19846|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
19847|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
19848|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
20007|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
19849|NCT02557646|E1|Reported Event|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
19850|NCT02557555|B1|Baseline|Labor Pain Control Pamphlet|All English or Spanish speaking patients were provided with a pamphlet during their prenatal visits and then again when entering the labor and delivery floor. The pamphlet contained information regarding labor analgesia alternatives (i.e Epidural, remifentanil PCA, morphine bolus, etc). After delivery, the patients were approached and asked to respond to a brief questionnaire.
19851|NCT02557555|P1|Participant Flow|Labor Pain Control Pamphlet|All English or Spanish speaking patients were provided with a pamphlet during their prenatal visits and then again when entering the labor and delivery floor. The pamphlet contained information regarding labor analgesia alternatives (i.e Epidural, remifentanil patient controlled analgesia, morphine bolus, etc). After delivery, the patients were approached and asked to respond to a brief questionnaire.
19852|NCT02557555|O2|Outcome|No %|Percentage of patients responding no to the key questions regarding the provided pamphlet educational value or anxiety
19853|NCT02557555|O1|Outcome|Yes %|Percentage of patients responding Yes to one of the key questions of the study regarding education value of the pamphlet and anxiety level.
19854|NCT02557555|E1|Reported Event|Labor Pain Control Pamphlet|All English or Spanish speaking patients were provided with a pamphlet during their prenatal visits and then again when entering the labor and delivery floor. The pamphlet contained information regarding labor analgesia alternatives (i.e Epidural, remifentanil PCA, morphine bolus, etc). After delivery, the patients were approached and asked to respond to a brief questionnaire.
19855|NCT02557399|B3|Baseline|Total|Total of all reporting groups
19856|NCT02557399|B2|Baseline|ADA 0.1% +CLDM 1%|Participants were instructed to use combination therapy of ADA 0.1% gel with quantity equal to about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
19857|NCT02557399|B1|Baseline|DUAC|Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity equal to about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
19858|NCT02557399|P2|Participant Flow|ADA 0.1% +CLDM 1%|Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.
19859|NCT02557399|P1|Participant Flow|DUAC|Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 finger tip unit (FTU) about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
19860|NCT02557399|O2|Outcome|ADA 0.1% +CLDM 1%|Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
19861|NCT02557399|O1|Outcome|DUAC|Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
19862|NCT02557399|O2|Outcome|ADA 0.1% +CLDM 1%|Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
19863|NCT02557399|O1|Outcome|DUAC|Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
19864|NCT02557399|O2|Outcome|ADA 0.1% +CLDM 1%|Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.
19865|NCT02557399|O1|Outcome|DUAC|Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
19866|NCT02557399|O2|Outcome|ADA 0.1% +CLDM 1%|Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
19867|NCT02557399|O1|Outcome|DUAC|Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
20008|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
19868|NCT02557399|O2|Outcome|ADA 0.1% +CLDM 1%|Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
19869|NCT02557399|O1|Outcome|DUAC|Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
19870|NCT02557399|O2|Outcome|ADA 0.1% +CLDM 1%|Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.
19871|NCT02557399|O1|Outcome|DUAC|Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
19872|NCT02557399|O2|Outcome|ADA 0.1% +CLDM 1%|Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.
19873|NCT02557399|O1|Outcome|DUAC|Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
19874|NCT02557399|O2|Outcome|ADA 0.1% +CLDM 1%|Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
19875|NCT02557399|O1|Outcome|DUAC|Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
19876|NCT02557399|O2|Outcome|ADA 0.1% +CLDM 1%|Participants were instructed to use combination therapy of ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
19877|NCT02557399|O1|Outcome|DUAC|Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
19878|NCT02557399|O2|Outcome|ADA 0.1% +CLDM 1%|Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
19879|NCT02557399|O1|Outcome|DUAC|Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
19880|NCT02557399|O2|Outcome|ADA 0.1% +CLDM 1%|Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
19881|NCT02557399|O1|Outcome|DUAC|Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
19882|NCT02557399|O2|Outcome|ADA 0.1% +CLDM 1%|Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
19883|NCT02557399|O1|Outcome|DUAC|Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
19884|NCT02557399|O2|Outcome|ADA 0.1% +CLDM 1%|Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
20009|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
20010|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
19885|NCT02557399|O1|Outcome|DUAC|Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
19886|NCT02557399|O2|Outcome|ADA 0.1% +CLDM 1%|Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
19887|NCT02557399|O1|Outcome|DUAC|Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
19888|NCT02557399|E2|Reported Event|ADA 0.1% +CLDM 1%|Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.
19889|NCT02557399|E1|Reported Event|Duac|Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
19890|NCT02556632|B4|Baseline|Total|Total of all reporting groups
19891|NCT02556632|B3|Baseline|Arm III (Placebo Gel)|"Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Apply placebo gel topically~Questionnaire Administration: Ancillary studies"
19892|NCT02556632|B2|Baseline|Arm II (HPR Plus)|"Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Dermatologic Complications Management: Apply HPR Plus topically~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
19893|NCT02556632|B1|Baseline|Arm I (Curcumin-based Gel)|"Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Curcumin-based Gel: Applied topically~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
19894|NCT02556632|P3|Participant Flow|Arm III (Placebo Gel)|"Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Apply placebo gel topically~Questionnaire Administration: Ancillary studies"
19895|NCT02556632|P2|Participant Flow|Arm II (HPR Plus)|"Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Dermatologic Complications Management: Apply HPR Plus topically~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
19896|NCT02556632|P1|Participant Flow|Arm I (Curcumin-based Gel)|"Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Curcumin-based Gel: Applied topically~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
19897|NCT02556632|O3|Outcome|Arm III (Placebo Gel)|"Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Apply placebo gel topically~Questionnaire Administration: Ancillary studies"
19898|NCT02556632|O2|Outcome|Arm II (HPR Plus)|"Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Dermatologic Complications Management: Apply HPR Plus topically~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
19899|NCT02556632|O1|Outcome|Arm I (Curcumin-based Gel)|"Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Curcumin-based Gel: Applied topically~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
19900|NCT02556632|O3|Outcome|Arm III (Placebo Gel)|"Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Apply placebo gel topically~Questionnaire Administration: Ancillary studies"
19901|NCT02556632|O2|Outcome|Arm II (HPR Plus)|"Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Dermatologic Complications Management: Apply HPR Plus topically~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
19902|NCT02556632|O1|Outcome|Arm I (Curcumin-based Gel)|"Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Curcumin-based Gel: Applied topically~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
19903|NCT02556632|O3|Outcome|Arm III (Placebo Gel)|"Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Apply placebo gel topically~Questionnaire Administration: Ancillary studies"
20011|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
20012|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
20013|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
19904|NCT02556632|O2|Outcome|Arm II (HPR Plus)|"Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Dermatologic Complications Management: Apply HPR Plus topically~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
19905|NCT02556632|O1|Outcome|Arm I (Curcumin-based Gel)|"Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Curcumin-based Gel: Applied topically~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
19906|NCT02556632|E3|Reported Event|Arm III (Placebo Gel)|"Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Apply placebo gel topically~Questionnaire Administration: Ancillary studies"
19907|NCT02556632|E2|Reported Event|Arm II (HPR Plus)|"Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Dermatologic Complications Management: Apply HPR Plus topically~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
19908|NCT02556632|E1|Reported Event|Arm I (Curcumin-based Gel)|"Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Curcumin-based Gel: Applied topically~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
19909|NCT02556333|B1|Baseline|TAF Treatment|Each subject receives tenofovir alafenamide (TAF) with emtricitabine to be added to a failing antiretroviral regimen for 10 days, if there is a HIV RNA response of >= 0.5 log decline, subjects will continue of TAF with emtricitabine with a new optimized background regimen. If <0.5 log decline, TAF with emtricitabine will be discontinued and study enrollment for the subject will be terminated.
19910|NCT02556333|P1|Participant Flow|TAF Treatment|Each subject receives tenofovir alafenamide (TAF) with emtricitabine to be added to a failing antiretroviral regimen for 10 days, if there is a HIV RNA response of >= 0.5 log decline, subjects will continue of TAF with emtricitabine with a new optimized background regimen. If <0.5 log decline, TAF with emtricitabine will be discontinued and study enrollment for the subject will be terminated.
19911|NCT02556333|O1|Outcome|TAF Treatment|Each subject receives tenofovir alafenamide (TAF) with emtricitabine to be added to a failing antiretroviral regimen for 10 days, if there is a HIV RNA response of >= 0.5 log decline, subjects will continue of TAF with emtricitabine with a new optimized background regimen. If <0.5 log decline, TAF with emtricitabine will be discontinued and study enrollment for the subject will be terminated.
19912|NCT02556333|E1|Reported Event|TAF Treatment|Each subject receives tenofovir alafenamide (TAF) with emtricitabine to be added to a failing antiretroviral regimen for 10 days, if there is a HIV RNA response of >= 0.5 log decline, subjects will continue of TAF with emtricitabine with a new optimized background regimen. If <0.5 log decline, TAF with emtricitabine will be discontinued and study enrollment for the subject will be terminated.
19913|NCT02556307|B1|Baseline|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
19914|NCT02556307|P1|Participant Flow|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current summaries of product characteristics (SPCs)/local labeling.
19915|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
19916|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
19917|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
19918|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
19919|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
19920|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
19921|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
19922|NCT02556307|E1|Reported Event|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
19923|NCT02556138|B1|Baseline|Orbera Intragastric Balloon|All subjects received the ORBERA Intragastric Balloon. The ORBERA Intragastric Balloon was placed in the stomach endoscopically through a catheter under conscious sedation. The procedure took about 20 minutes to complete. The balloon stayed in place for 6 months and then it was removed endoscopically.
19924|NCT02556138|P1|Participant Flow|Orbera Intragastric Balloon|All subjects received the ORBERA Intragastric Balloon. The ORBERA Intragastric Balloon was placed in the stomach endoscopically through a catheter under conscious sedation. The procedure took about 20 minutes to complete. The balloon stayed in place for 6 months and then it was removed endoscopically.
19925|NCT02556138|O1|Outcome|Orbera Intragastric Balloon|All subjects received the ORBERA Intragastric Balloon. The ORBERA Intragastric Balloon was placed in the stomach endoscopically through a catheter under conscious sedation. The procedure took about 20 minutes to complete. The balloon stayed in place for 6 months and then it was removed endoscopically.
19926|NCT02556138|O1|Outcome|Orbera Intragastric Balloon|All subjects received the ORBERA Intragastric Balloon. The ORBERA Intragastric Balloon was placed in the stomach endoscopically through a catheter under conscious sedation. The procedure took about 20 minutes to complete. The balloon stayed in place for 6 months and then it was removed endoscopically.
20014|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
19927|NCT02556138|O1|Outcome|Orbera Intragastric Balloon|All subjects received the ORBERA Intragastric Balloon. The ORBERA Intragastric Balloon was placed in the stomach endoscopically through a catheter under conscious sedation. The procedure took about 20 minutes to complete. The balloon stayed in place for 6 months and then it was removed endoscopically.
19928|NCT02556138|E1|Reported Event|Orbera Intragastric Balloon|All subjects received the ORBERA Intragastric Balloon. The ORBERA Intragastric Balloon was placed in the stomach endoscopically through a catheter under conscious sedation. The procedure took about 20 minutes to complete. The balloon stayed in place for 6 months and then it was removed endoscopically.
19929|NCT02555722|B3|Baseline|Total|Total of all reporting groups
19930|NCT02555722|B2|Baseline|Enfilcon A (Control)|"Subjects will be randomized to wear enfilcon A lens (control) for one month of daily wear during the study.~enfilcon A (control): silicone hydrogel lens"
19931|NCT02555722|B1|Baseline|Fanfilcon A (Test)|"Subjects will be randomized to wear fanfilcon A lens (test) for one month of daily wear during the study.~fanfilcon A (test): silicone hydrogel lens"
19932|NCT02555722|P2|Participant Flow|Enfilcon A (Control)|"Subjects will be randomized to wear enfilcon A lens (control) for one month of daily wear during the study.~enfilcon A (control): silicone hydrogel lens"
19933|NCT02555722|P1|Participant Flow|Fanfilcon A (Test)|"Subjects will be randomized to wear fanfilcon A lens (test) for one month of daily wear during the study.~fanfilcon A (test): silicone hydrogel lens"
19934|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
19935|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
19936|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
19937|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
19938|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
19939|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
19940|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
19941|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
19942|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
19943|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
19944|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
19945|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
19946|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
19947|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
19948|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
19949|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
19950|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
19951|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
19952|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
19953|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
19954|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
19955|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
19956|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
19957|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
19958|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
19959|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
19960|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
19961|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
19962|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
19963|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
19964|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
19965|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
19966|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
19967|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
19968|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
19969|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
19970|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
19971|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
19972|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
19973|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
19974|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
19975|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
19976|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
19977|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
19978|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
19979|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
19980|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
19981|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
19982|NCT02555722|O5|Outcome|Month 3|enfilcon A lens (control)
19983|NCT02555722|O4|Outcome|Month 2|enfilcon A lens (control)
19984|NCT02555722|O3|Outcome|Month 1|enfilcon A lens (control)
19985|NCT02555722|O2|Outcome|Week 2|enfilcon A lens (control)
19986|NCT02555722|O1|Outcome|Week 1|enfilcon A lens (control)
19987|NCT02555722|O5|Outcome|Month 3|fanfilcon A lens (test)
19988|NCT02555722|O4|Outcome|Month 2|fanfilcon A lens (test)
19989|NCT02555722|O3|Outcome|Month 1|fanfilcon A lens (test)
19990|NCT02555722|O2|Outcome|Week 2|fanfilcon A lens (test)
19991|NCT02555722|O1|Outcome|Week 1|fanfilcon A lens (test)
19992|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
19993|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
19994|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
19995|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
19996|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
19997|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
19998|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
19999|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
20000|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
20001|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
20088|NCT02555722|E2|Reported Event|Enfilcon A (Control)|"Subjects will be randomized to wear enfilcon A lens (control) for one month of daily wear during the study.~enfilcon A (control): silicone hydrogel lens"
20089|NCT02555722|E1|Reported Event|Fanfilcon A (Test)|"Subjects will be randomized to wear fanfilcon A lens (test) for one month of daily wear during the study.~fanfilcon A (test): silicone hydrogel lens"
20090|NCT02555618|B3|Baseline|Total|Total of all reporting groups
20091|NCT02555618|B2|Baseline|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
20092|NCT02555618|B1|Baseline|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
20093|NCT02555618|P2|Participant Flow|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
20094|NCT02555618|P1|Participant Flow|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
20095|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
20096|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
20097|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
20098|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
20099|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
20100|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
20101|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
20102|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
20103|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
20104|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
20105|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
20106|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
20107|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
20108|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
20109|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
20110|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
20111|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
20112|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
20113|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
20114|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
20115|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
20116|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
20117|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
20118|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
20119|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
20120|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
20121|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
20122|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
20123|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
20124|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
20125|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
20126|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
20127|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
20128|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
20129|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
20130|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
20131|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
20132|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
20133|NCT02555618|E2|Reported Event|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
20134|NCT02555618|E1|Reported Event|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
20135|NCT02555228|B3|Baseline|Total|Total of all reporting groups
20136|NCT02555228|B2|Baseline|Placebo|"Just 5 mls of water~Water: 5mls of water is given at least 30 minutes before the gastroscopy."
20137|NCT02555228|B1|Baseline|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water~Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy."
20138|NCT02555228|P2|Participant Flow|Placebo|"Just 5 mls of water~Water: 5mls of water is given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
20139|NCT02555228|P1|Participant Flow|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water~Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
20140|NCT02555228|O2|Outcome|Placebo|"Just 5 mls of water~Water: 5mls of water is given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
20141|NCT02555228|O1|Outcome|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water~Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
20142|NCT02555228|O2|Outcome|Placebo|"Just 5 mls of water~Water: 5mls of water is given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
20143|NCT02555228|O1|Outcome|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water~Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
20144|NCT02555228|O2|Outcome|Placebo|"Just 5 mls of water~Water: 5mls of water is given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
20145|NCT02555228|O1|Outcome|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water~Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
20146|NCT02555228|O2|Outcome|Placebo|"Just 5 mls of water~Water: 5mls of water is given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
20147|NCT02555228|O1|Outcome|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water~Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
20148|NCT02555228|E2|Reported Event|Placebo|"Just 5 mls of water~Water: 5mls of water is given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
20149|NCT02555228|E1|Reported Event|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water~Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
20150|NCT02554981|B1|Baseline|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
20151|NCT02554981|P1|Participant Flow|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
20152|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
20153|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
20154|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
20155|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
20156|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
20157|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
20158|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
20159|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
20160|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
20161|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
20162|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
20163|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
20164|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
20165|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
20166|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
20167|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
20168|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
20169|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
20170|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
20171|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
20172|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
20173|NCT02554981|E1|Reported Event|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
20174|NCT02554877|B5|Baseline|Total|Total of all reporting groups
20175|NCT02554877|B4|Baseline|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20176|NCT02554877|B3|Baseline|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20177|NCT02554877|B2|Baseline|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20178|NCT02554877|B1|Baseline|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20179|NCT02554877|P4|Participant Flow|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20180|NCT02554877|P3|Participant Flow|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20181|NCT02554877|P2|Participant Flow|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20182|NCT02554877|P1|Participant Flow|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20183|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20184|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20185|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20186|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20187|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20188|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20189|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20190|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20191|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20192|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20193|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20194|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20195|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20196|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20197|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20198|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20199|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20200|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20201|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20202|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20203|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20204|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20205|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20206|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20207|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20208|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20209|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20210|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20211|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20212|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20213|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20214|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20215|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20216|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20217|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20218|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20219|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20220|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20221|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20222|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20223|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20224|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20225|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20226|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20227|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20228|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20229|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20230|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20231|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20232|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20233|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20234|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20235|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20236|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20237|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20238|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20239|NCT02554877|E4|Reported Event|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20240|NCT02554877|E3|Reported Event|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20241|NCT02554877|E2|Reported Event|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20242|NCT02554877|E1|Reported Event|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
20243|NCT02554279|B3|Baseline|Total|Total of all reporting groups
20244|NCT02554279|B2|Baseline|Recombinant FSH|Follitropin alpha for injection, human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
20245|NCT02554279|B1|Baseline|Menotropin|Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
20246|NCT02554279|P2|Participant Flow|Recombinant FSH|Follitropin alpha for injection, a human FSH preparation of recombinant deoxyribonucleic acid (DNA) origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
20247|NCT02554279|P1|Participant Flow|Menotropin|Menotropins for injection, provided as a vial with powder (75 international units [IU] follicle stimulating hormone [FSH] activity and 75 IU luteinizing hormone [LH] activity) and a vial with diluent.
20248|NCT02554279|O2|Outcome|Recombinant FSH|Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
20249|NCT02554279|O1|Outcome|Menotropin|Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
20250|NCT02554279|O2|Outcome|Recombinant FSH|Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
20251|NCT02554279|O1|Outcome|Menotropin|Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
20252|NCT02554279|O2|Outcome|Recombinant FSH|Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
20253|NCT02554279|O1|Outcome|Menotropin|Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
20254|NCT02554279|O2|Outcome|Recombinant FSH|Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
20255|NCT02554279|O1|Outcome|Menotropin|Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
20256|NCT02554279|O2|Outcome|Recombinant FSH|Follitropin alpha for injection, human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
20257|NCT02554279|O1|Outcome|Menotropin|Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
20258|NCT02554279|O2|Outcome|Recombinant FSH|Follitropin alpha for injection, human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
20259|NCT02554279|O1|Outcome|Menotropin|Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
20260|NCT02554279|O4|Outcome|Recombinant FSH, Last Stimulation Day|recombinant FSH at last stimulation day. Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
20261|NCT02554279|O3|Outcome|Menotropin, Last Stimulation Day|Menotropin at last stimulation day. Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
20262|NCT02554279|O2|Outcome|Recombinant FSH, Stimulation Day 6|Recombinant FSH at stimulation Day 6. Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
20263|NCT02554279|O1|Outcome|Menotropin, Stimulation Day 6|Menotropins for injection at stimulation Day 6. Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
20264|NCT02554279|O4|Outcome|Recombinant FSH, Last Stimulation Day|Recombinant FSH at last stimulation day. Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity
20265|NCT02554279|O3|Outcome|Menotropin, Last Stimulation Day|Menotropin at last stimulation day. Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
20266|NCT02554279|O2|Outcome|Recombinant FSH, Stimulation Day 6|Recombinant FSH at stimulation Day 6. Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
20267|NCT02554279|O1|Outcome|Menotropin, Stimulation Day 6|Menotropins for injection at stimulation Day 6. Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
20268|NCT02554279|O2|Outcome|Recombinant FSH|Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
20269|NCT02554279|O1|Outcome|Menotropin|Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
20270|NCT02554279|O2|Outcome|Recombinant FSH|Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
20271|NCT02554279|O1|Outcome|Menotropin|Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
20272|NCT02554279|O2|Outcome|Recombinant FSH|Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
20273|NCT02554279|O1|Outcome|Menotropin|Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
20274|NCT02554279|O2|Outcome|Recombinant FSH|Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
20275|NCT02554279|O1|Outcome|Menotropin|Menotropins for injection, provided as a vial with powder (75 IU activity and 75 IU LH activity) and a vial with diluent.
20276|NCT02554279|E2|Reported Event|Recombinant FSH|Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
20277|NCT02554279|E1|Reported Event|Menotropin|Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
20278|NCT02553772|B3|Baseline|Total|Total of all reporting groups
20279|NCT02553772|B2|Baseline|REFRESH OPTIVE® ADVANCED|Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
20280|NCT02553772|B1|Baseline|OM3 Tear|Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
20281|NCT02553772|P2|Participant Flow|REFRESH OPTIVE® ADVANCED|Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
20282|NCT02553772|P1|Participant Flow|OM3 Tear|Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
20283|NCT02553772|O2|Outcome|REFRESH OPTIVE® ADVANCED|Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
20284|NCT02553772|O1|Outcome|OM3 Tear|Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
20285|NCT02553772|O2|Outcome|REFRESH OPTIVE® ADVANCED|Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
20286|NCT02553772|O1|Outcome|OM3 Tear|Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
20287|NCT02553772|O2|Outcome|REFRESH OPTIVE® ADVANCED|Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
20288|NCT02553772|O1|Outcome|OM3 Tear|Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
20289|NCT02553772|O2|Outcome|REFRESH OPTIVE® ADVANCED|Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
20290|NCT02553772|O1|Outcome|OM3 Tear|Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
20291|NCT02553772|O2|Outcome|REFRESH OPTIVE® ADVANCED|Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
20292|NCT02553772|O1|Outcome|OM3 Tear|Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
20293|NCT02553772|E2|Reported Event|REFRESH OPTIVE® ADVANCED|Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
20294|NCT02553772|E1|Reported Event|OM3 Tear|Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
20295|NCT02553629|B3|Baseline|Total|Total of all reporting groups
20296|NCT02553629|B2|Baseline|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
20297|NCT02553629|B1|Baseline|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
20298|NCT02553629|P2|Participant Flow|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
20299|NCT02553629|P1|Participant Flow|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
20300|NCT02553629|O2|Outcome|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
20301|NCT02553629|O1|Outcome|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
20302|NCT02553629|O2|Outcome|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
20303|NCT02553629|O1|Outcome|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
20304|NCT02553629|O2|Outcome|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
20305|NCT02553629|O1|Outcome|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
20306|NCT02553629|O2|Outcome|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
20307|NCT02553629|O1|Outcome|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
20308|NCT02553629|O2|Outcome|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
20309|NCT02553629|O1|Outcome|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
20310|NCT02553629|E2|Reported Event|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
20311|NCT02553629|E1|Reported Event|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
20312|NCT02553538|B3|Baseline|Total|Total of all reporting groups
20313|NCT02553538|B2|Baseline|Standard of Care - No Intervention|Patients randomized to the control arm received usual care within TopCare, which meant that clinicians and staff could elect to send the patient a reminder letter about their overdue cancer screening exams, reach out to schedule overdue exams, or document appropriate reasons for deferral or exclusion.
20314|NCT02553538|B1|Baseline|Patient Navigation Intervention|Patients randomized to the intervention arm were transferred to a navigator roster within the TopCare application for the 8-month study period. Navigators utilized TopCare to track these patients, reach out to them in their own language, and provide intense outreach to help them complete cancer screening.
20315|NCT02553538|P2|Participant Flow|Standard of Care - No Intervention|Patients randomized to the control arm received usual care within TopCare, which meant that clinicians and staff could elect to send the patient a reminder letter about their overdue cancer screening exams, reach out to schedule overdue exams, or document appropriate reasons for deferral or exclusion.
20316|NCT02553538|P1|Participant Flow|Patient Navigation Intervention|Patients randomized to the intervention arm were transferred to a navigator roster within the TopCare application for the 8-month study period. Navigators utilized TopCare to track these patients, reach out to them in their own language, and provide intense outreach to help them complete cancer screening.
20317|NCT02553538|O2|Outcome|Standard of Care - No Intervention|Patients randomized to the control arm received usual care within TopCare, which meant that clinicians and staff could elect to send the patient a reminder letter about their overdue cancer screening exams, reach out to schedule overdue exams, or document appropriate reasons for deferral or exclusion.
20318|NCT02553538|O1|Outcome|Patient Navigation Intervention|Patients randomized to the intervention arm were transferred to a navigator roster within the TopCare application for the 8-month study period. Navigators utilized TopCare to track these patients, reach out to them in their own language, and provide intense outreach to help them complete cancer screening.
20319|NCT02553538|O2|Outcome|Standard of Care - No Intervention|Patients randomized to the control arm received usual care within TopCare, which meant that clinicians and staff could elect to send the patient a reminder letter about their overdue cancer screening exams, reach out to schedule overdue exams, or document appropriate reasons for deferral or exclusion.
20320|NCT02553538|O1|Outcome|Patient Navigation Intervention|Patients randomized to the intervention arm were transferred to a navigator roster within the TopCare application for the 8-month study period. Navigators utilized TopCare to track these patients, reach out to them in their own language, and provide intense outreach to help them complete cancer screening.
20321|NCT02553538|O2|Outcome|Standard of Care - No Intervention|Patients randomized to the control arm received usual care within TopCare, which meant that clinicians and staff could elect to send the patient a reminder letter about their overdue cancer screening exams, reach out to schedule overdue exams, or document appropriate reasons for deferral or exclusion.
20322|NCT02553538|O1|Outcome|Patient Navigation Intervention|Patients randomized to the intervention arm were transferred to a navigator roster within the TopCare application for the 8-month study period. Navigators utilized TopCare to track these patients, reach out to them in their own language, and provide intense outreach to help them complete cancer screening.
20323|NCT02553538|O2|Outcome|Standard of Care - No Intervention|Patients randomized to the control arm received usual care within TopCare, which meant that clinicians and staff could elect to send the patient a reminder letter about their overdue cancer screening exams, reach out to schedule overdue exams, or document appropriate reasons for deferral or exclusion.
20324|NCT02553538|O1|Outcome|Patient Navigation Intervention|Patients randomized to the intervention arm were transferred to a navigator roster within the TopCare application for the 8-month study period. Navigators utilized TopCare to track these patients, reach out to them in their own language, and provide intense outreach to help them complete cancer screening.
20325|NCT02553538|E2|Reported Event|Standard of Care - No Intervention|Patients randomized to the control arm received usual care within TopCare, which meant that clinicians and staff could elect to send the patient a reminder letter about their overdue cancer screening exams, reach out to schedule overdue exams, or document appropriate reasons for deferral or exclusion.
20326|NCT02553538|E1|Reported Event|Patient Navigation Intervention|Patients randomized to the intervention arm were transferred to a navigator roster within the TopCare application for the 8-month study period. Navigators utilized TopCare to track these patients, reach out to them in their own language, and provide intense outreach to help them complete cancer screening.
20327|NCT02553512|B1|Baseline|Helius|Ingestible Sensor and Wearable Sensor
20328|NCT02553512|P1|Participant Flow|Helius|Ingestible Sensor and Wearable Sensor
20329|NCT02553512|O1|Outcome|Helius|Ingestible Sensor and Wearable Sensor
20330|NCT02553512|O1|Outcome|Helius|Ingestible Sensor and Wearable Sensor
20331|NCT02553512|O1|Outcome|Helius|Ingestible Sensor and Wearable Sensor
20332|NCT02553512|O1|Outcome|Helius|Ingestible Sensor and Wearable Sensor
20333|NCT02553512|O1|Outcome|Helius|Ingestible Sensor and Wearable Sensor
20334|NCT02553512|E1|Reported Event|Helius|Ingestible Sensor and Wearable Sensor
20335|NCT02553421|B3|Baseline|Total|Total of all reporting groups
20336|NCT02553421|B2|Baseline|Alarming|"The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses."
20497|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
20337|NCT02553421|B1|Baseline|Non-alarming|"The ivWatch device will monitor the IV sites but will not issue infiltration notifications.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.~Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms."
20338|NCT02553421|P2|Participant Flow|Alarming|"The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses."
20339|NCT02553421|P1|Participant Flow|Non-alarming|"The ivWatch device will monitor the IV sites but will not issue infiltration notifications.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.~Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms."
20340|NCT02553421|O1|Outcome|Alarming|"The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses."
20341|NCT02553421|O2|Outcome|Alarming|"The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses."
20342|NCT02553421|O1|Outcome|Non-alarming|"The ivWatch device will monitor the IV sites but will not issue infiltration notifications.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.~Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms."
20343|NCT02553421|O1|Outcome|Non-alarming|"The ivWatch device will monitor the IV sites but will not issue infiltration notifications.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.~Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms."
20344|NCT02553421|E2|Reported Event|Alarming|"The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses."
20345|NCT02553421|E1|Reported Event|Non-alarming|"The ivWatch device will monitor the IV sites but will not issue infiltration notifications.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.~Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms."
20346|NCT02552810|B3|Baseline|Total|Total of all reporting groups
20347|NCT02552810|B2|Baseline|Control Group|Control group were cleaned by steam for 30s 7 by the dental technician in the laboratory located in the same clinic, but in a different room, immediately before delivering to the clinician. Then all the abutments were then handed to the clinician in a sterile envelope, without the possibility to evaluate the treatment undergone.
20348|NCT02552810|B1|Baseline|Test Group|Test group abutments, after milled, polished and cleaned for 30s in the same laboratory, underwent argon plasma treatment (75 W of power and -10 MPa of pressure for 12 minutes at room temperature) in a plasma reactor8 located in the same clinic but in a different room. All the abutments were then handed to the clinician in a sterile envelope, without the possibility to evaluate the treatment undergone.
20349|NCT02552810|P2|Participant Flow|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
20350|NCT02552810|P1|Participant Flow|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
20351|NCT02552810|O2|Outcome|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
20397|NCT02551887|O2|Outcome|Automated Reminder|Automated Reminder: Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.
20398|NCT02551887|O1|Outcome|Usual Care|Non-interventional study arm. Patients receive usual care.
20399|NCT02551887|E3|Reported Event|Automated Reminder Plus Recommended Script|In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
20352|NCT02552810|O1|Outcome|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
20353|NCT02552810|O2|Outcome|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
20354|NCT02552810|O1|Outcome|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
20355|NCT02552810|O2|Outcome|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
20356|NCT02552810|O1|Outcome|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
20357|NCT02552810|O2|Outcome|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
20358|NCT02552810|O1|Outcome|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
20359|NCT02552810|O2|Outcome|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
20360|NCT02552810|O1|Outcome|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
20361|NCT02552810|O2|Outcome|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
20362|NCT02552810|O1|Outcome|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
20668|NCT02549027|E3|Reported Event|MK-1064 250 mg|Single dose of 250 mg MK-1064
20363|NCT02552810|E2|Reported Event|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
20364|NCT02552810|E1|Reported Event|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
20365|NCT02552303|B5|Baseline|Total|Total of all reporting groups
20366|NCT02552303|B4|Baseline|Placebo|"Placebo only, without CBTI.~Placebo: Placebo for Nuvigil (armodafinil)"
20367|NCT02552303|B3|Baseline|Armodafinil|"Medication (armodafinil) only, without CBTI.~Armodafinil: Active medication"
20368|NCT02552303|B2|Baseline|CBTI + Placebo|"Cognitive Behavioral Therapy for Insomnia with Placebo medication~Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.~Placebo: Placebo for Nuvigil (armodafinil)"
20369|NCT02552303|B1|Baseline|CBT for Insomnia (CBTI) + Armodafinil|"CBT-I with Armodafinil (active medication)~Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.~Armodafinil: Active medication"
20370|NCT02552303|P4|Participant Flow|Placebo|"Placebo only, without CBTI.~Placebo: Placebo for Nuvigil (armodafinil)"
20371|NCT02552303|P3|Participant Flow|Armodafinil|"Medication (armodafinil) only, without CBTI.~Armodafinil: Active medication"
20372|NCT02552303|P2|Participant Flow|CBTI + Placebo|"Cognitive Behavioral Therapy for Insomnia with Placebo medication~Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.~Placebo: Placebo for Nuvigil (armodafinil)"
20373|NCT02552303|P1|Participant Flow|CBT for Insomnia (CBTI) + Armodafinil|"CBT-I with Armodafinil (active medication)~Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.~Armodafinil: Active medication"
20374|NCT02552303|O4|Outcome|Placebo|"Placebo only, without CBTI.~Placebo: Placebo for Nuvigil (armodafinil)"
20375|NCT02552303|O3|Outcome|Armodafinil|"Medication (armodafinil) only, without CBTI.~Armodafinil: Active medication"
20376|NCT02552303|O2|Outcome|CBTI + Placebo|"Cognitive Behavioral Therapy for Insomnia with Placebo medication~Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.~Placebo: Placebo for Nuvigil (armodafinil)"
20377|NCT02552303|O1|Outcome|CBT for Insomnia (CBTI) + Armodafinil|"CBT-I with Armodafinil (active medication)~Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.~Armodafinil: Active medication"
20378|NCT02552303|O4|Outcome|Placebo|"Placebo only, without CBTI.~Placebo: Placebo for Nuvigil (armodafinil)"
20379|NCT02552303|O3|Outcome|Armodafinil|"Medication (armodafinil) only, without CBTI.~Armodafinil: Active medication"
20380|NCT02552303|O2|Outcome|CBTI + Placebo|"Cognitive Behavioral Therapy for Insomnia with Placebo medication~Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.~Placebo: Placebo for Nuvigil (armodafinil)"
20381|NCT02552303|O1|Outcome|CBT for Insomnia (CBTI) + Armodafinil|"CBT-I with Armodafinil (active medication)~Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.~Armodafinil: Active medication"
20382|NCT02552303|E4|Reported Event|Placebo|"Placebo only, without CBTI.~Placebo: Placebo for Nuvigil (armodafinil)"
20383|NCT02552303|E3|Reported Event|Armodafinil|"Medication (armodafinil) only, without CBTI.~Armodafinil: Active medication"
20384|NCT02552303|E2|Reported Event|CBTI + Placebo|"Cognitive Behavioral Therapy for Insomnia with Placebo medication~Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.~Placebo: Placebo for Nuvigil (armodafinil)"
20385|NCT02552303|E1|Reported Event|CBT for Insomnia (CBTI) + Armodafinil|"CBT-I with Armodafinil (active medication)~Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.~Armodafinil: Active medication"
20386|NCT02551887|B4|Baseline|Total|Total of all reporting groups
20387|NCT02551887|B3|Baseline|Automated Reminder Plus Recommended Script|Automated Reminder Plus Recommended Script: In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
20388|NCT02551887|B2|Baseline|Automated Reminder|Automated Reminder: Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.
20389|NCT02551887|B1|Baseline|Usual Care|Non-interventional study arm. Patients receive usual care.
20390|NCT02551887|P3|Participant Flow|Automated Reminder Plus Recommended Script|Automated Reminder Plus Recommended Script: In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
20391|NCT02551887|P2|Participant Flow|Automated Reminder|Automated Reminder: Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.
20392|NCT02551887|P1|Participant Flow|Usual Care|Non-interventional study arm. Patients receive usual care.
20393|NCT02551887|O3|Outcome|Automated Reminder Plus Recommended Script|Automated Reminder Plus Recommended Script: In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
20394|NCT02551887|O2|Outcome|Automated Reminder|Automated Reminder: Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.
20395|NCT02551887|O1|Outcome|Usual Care|Non-interventional study arm. Patients receive usual care.
20396|NCT02551887|O3|Outcome|Automated Reminder Plus Recommended Script|Automated Reminder Plus Recommended Script: In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
20669|NCT02549027|E2|Reported Event|MK-1064 120 mg|Single dose of 120 mg MK-1064
20400|NCT02551887|E2|Reported Event|Automated Reminder|Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.
20401|NCT02551887|E1|Reported Event|Usual Care|Patients receive usual care.
20402|NCT02551822|B3|Baseline|Total|Total of all reporting groups
20403|NCT02551822|B2|Baseline|Group B (Continuous, Then Cycling)|"Sacral neuromodulator devices (implanted pulse generator) will be programmed to be on continuously. This means the devices are continuously on. They are on a continuous program.~sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation.~The first intervention (continuous) occurred at baseline, and the second intervention occurred at 3 months (cycling)."
20404|NCT02551822|B1|Baseline|Group A (Cycling, Then Continuous)|"Sacral neuromodulator devices (implanted pulse generator) will be programmed to on-off cycles (on 16 seconds, off 8 seconds). This means the devices are not continuously on. Rather they are on a cycling program.~sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation.~The first intervention (cycling) occurred at baseline, and the second intervention occurred at 3 months (continuous)."
20405|NCT02551822|P2|Participant Flow|Continuous, Then Cycling|Women will be randomized to the continuing or cycling arm at 0 months. At 3 months, women will report for their second postoperative visit. Prior to this visit, study subjects will complete the third 3-day voiding diary and record pad usage. At the visit, women will complete the OAB-q SF as well as the PGI-I, and will be queried regarding any complications since the start of the use of their modulator. At the 3 month visit, women who were assigned to continuous stimulation will be switched to cycling stimulation and women who were assigned to cycling stimulation will be switched to continuous stimulation. Women again will report for clinical follow-up at six months. Women will be asked to complete a fourth 3 day voiding diary. In addition, women will be asked to record any complications that they have had in the preceding 3 months. At this clinic visit women will once again complete the OAB-q SF and PGI-I.
20406|NCT02551822|P1|Participant Flow|Cycling, Then Continuous|Women will be randomized to the continuing or cycling arm at 0 months. At 3 months, women will report for their second postoperative visit. Prior to this visit, study subjects will complete the third 3-day voiding diary and record pad usage. At the visit, women will complete the OAB-q SF as well as the PGI-I, and will be queried regarding any complications since the start of the use of their modulator. At the 3 month visit, women who were assigned to continuous stimulation will be switched to cycling stimulation and women who were assigned to cycling stimulation will be switched to continuous stimulation. Women again will report for clinical follow-up at six months. Women will be asked to complete a fourth 3 day voiding diary. In addition, women will be asked to record any complications that they have had in the preceding 3 months. At this clinic visit women will once again complete the OAB-q SF and PGI-I.
20407|NCT02551822|O2|Outcome|Continuous, Then Cycling|"Sacral neuromodulator devices (implanted pulse generator) will be programmed to be on continuously. This means the devices are continuously on. They are on a continuous program.~sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation."
20408|NCT02551822|O1|Outcome|Cycling, Then Continuous|"Sacral neuromodulator devices (implanted pulse generator) will be programmed to on-off cycles (on 16 seconds, off 8 seconds). This means the devices are not continuously on. Rather they are on a cycling program.~sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation."
20409|NCT02551822|O2|Outcome|Continuous, Then Cycling|"Sacral neuromodulator devices (implanted pulse generator) will be programmed to be on continuously. This means the devices are continuously on. They are on a continuous program.~sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation."
20410|NCT02551822|O1|Outcome|Cycling, Then Continuous|"Sacral neuromodulator devices (implanted pulse generator) will be programmed to on-off cycles (on 16 seconds, off 8 seconds). This means the devices are not continuously on. Rather they are on a cycling program.~sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation."
20411|NCT02551822|O2|Outcome|Continuous, Then Cycling|"Sacral neuromodulator devices (implanted pulse generator) will be programmed to be on continuously. This means the devices are continuously on. They are on a continuous program.~sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation."
20412|NCT02551822|O1|Outcome|Cycling, Then Continuous|"Sacral neuromodulator devices (implanted pulse generator) will be programmed to on-off cycles (on 16 seconds, off 8 seconds). This means the devices are not continuously on. Rather they are on a cycling program.~sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation."
20413|NCT02551822|E2|Reported Event|Arm 2: Continuous|"Sacral neuromodulator devices (implanted pulse generator) will be programmed to be on continuously. This means the devices are continuously on. They are on a continuous program.~sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation."
20414|NCT02551822|E1|Reported Event|Arm 1: Cycling|"Sacral neuromodulator devices (implanted pulse generator) will be programmed to on-off cycles (on 16 seconds, off 8 seconds). This means the devices are not continuously on. Rather they are on a cycling program.~sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation."
20415|NCT02551224|B1|Baseline|Overall|Half of the patients will be assigned to first receive a single dose of placebo via the Breezhaler® followed by (minimum of 5 minutes) a single dose of placebo via the Ellipta® inhalation device. The evaluation questionnaires were administered after using each device.
20416|NCT02551224|P2|Participant Flow|Ellipta Then, Breezhaler Group 2|Half of the patients will be assigned to first receive a single dose of placebo via the Ellipta® followed by (minimum of 5 minutes) a single dose of placebo via the Breezhaler® inhalation device. The evaluation questionnaires administered after using each device.
20417|NCT02551224|P1|Participant Flow|Breezhaler, Then Ellipta group1|Half of the patients will be assigned to first receive a single dose of placebo via the Breezhaler® followed by (minimum of 5 minutes) a single dose of placebo via the Ellipta® inhalation device. The evaluation questionnaires are administered after using each device.
20455|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
20670|NCT02549027|E1|Reported Event|MK-1064 50 mg|Single dose of 50 mg MK-1064
20418|NCT02551224|O2|Outcome|Ellipta|Half of the patients will be assigned to first receive a single dose of placebo via the Ellipta® followed by (minimum of 5 minutes) a single dose of placebo via the Breezhaler® inhalation device. The evaluation questionnaires were administered after using each device.
20419|NCT02551224|O1|Outcome|Breezhaler|Half of the patients will be assigned to first receive a single dose of placebo via the Breezhaler® followed by (minimum of 5 minutes) a single dose of placebo via the Ellipta® inhalation device. The evaluation questionnaires were administered after using each device.
20420|NCT02551224|O2|Outcome|Ellipta|Half of the patients will be assigned to first receive a single dose of placebo via the Ellipta® followed by (minimum of 5 minutes) a single dose of placebo via the Breezhaler® inhalation device. The evaluation questionnaires were administered after using each device.
20421|NCT02551224|O1|Outcome|Breezhaler|Half of the patients will be assigned to first receive a single dose of placebo via the Breezhaler® followed by (minimum of 5 minutes) a single dose of placebo via the Ellipta® inhalation device. The evaluation questionnaires were administered after using each device.
20422|NCT02551224|E2|Reported Event|Ellipta|Half of the patients will be assigned to first receive a single dose of placebo via the Ellipta® followed by (minimum of 5 minutes) a single dose of placebo via the Breezhaler® inhalation device. The evaluation questionnaires were administered after using each device.
20423|NCT02551224|E1|Reported Event|Breezhaler|Half of the patients will be assigned to first receive a single dose of placebo via the Breezhaler® followed by (minimum of 5 minutes) a single dose of placebo via the Ellipta® inhalation device. The evaluation questionnaires were administered after using each device.
20424|NCT02550288|B6|Baseline|Total|Total of all reporting groups
20425|NCT02550288|B5|Baseline|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
20426|NCT02550288|B4|Baseline|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
20427|NCT02550288|B3|Baseline|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
20428|NCT02550288|B2|Baseline|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
20429|NCT02550288|B1|Baseline|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
20430|NCT02550288|P5|Participant Flow|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
20431|NCT02550288|P4|Participant Flow|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
20432|NCT02550288|P3|Participant Flow|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
20433|NCT02550288|P2|Participant Flow|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
20434|NCT02550288|P1|Participant Flow|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
20435|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
20436|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
20437|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
20438|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
20439|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
20440|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
20441|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
20442|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
20443|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
20444|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
20445|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
20446|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
20447|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
20448|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
20449|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
20450|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
20451|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
20452|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
20453|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
20454|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
20456|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
20457|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
20458|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
20459|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
20460|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
20461|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
20462|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
20463|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
20464|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
20465|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
20466|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
20467|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
20468|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
20469|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
20470|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
20471|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
20472|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
20473|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
20474|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
20475|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
20476|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
20477|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
20478|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
20479|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
20480|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
20481|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
20482|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
20483|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
20484|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
20485|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
20486|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
20487|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
20488|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
20489|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
20490|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
20491|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
20492|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
20493|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
20494|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
20495|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
20496|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
20498|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
20499|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
20500|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
20501|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
20502|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
20503|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
20504|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
20505|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
20506|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
20507|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
20508|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
20509|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
20510|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
20511|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
20512|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
20513|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
20514|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
20515|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
20516|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
20517|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
20518|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
20519|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
20520|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
20521|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
20522|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
20523|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
20524|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
20525|NCT02550288|E5|Reported Event|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
20526|NCT02550288|E4|Reported Event|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
20527|NCT02550288|E3|Reported Event|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
20528|NCT02550288|E2|Reported Event|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
20529|NCT02550288|E1|Reported Event|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
20530|NCT02550197|B3|Baseline|Total|Total of all reporting groups
20531|NCT02550197|B2|Baseline|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
20532|NCT02550197|B1|Baseline|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
20533|NCT02550197|P2|Participant Flow|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
20534|NCT02550197|P1|Participant Flow|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
20535|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
20536|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
20671|NCT02549014|B3|Baseline|Total|Total of all reporting groups
20537|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
20538|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
20539|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
20540|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
20541|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
20542|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
20543|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
20544|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
20545|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
20546|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
20547|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
20548|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
20549|NCT02550197|E2|Reported Event|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
20550|NCT02550197|E1|Reported Event|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
20551|NCT02550132|B1|Baseline|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20552|NCT02550132|P1|Participant Flow|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20553|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20554|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20555|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20556|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20557|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20558|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20692|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20559|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20560|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20561|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20562|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20563|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20564|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20565|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20566|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20567|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20568|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20569|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20570|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20571|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20572|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20573|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20693|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
33126|NCT02423408|B3|Baseline|Total|Total of all reporting groups
20574|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20575|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20576|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20577|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20578|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20579|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20580|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20581|NCT02550132|E1|Reported Event|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
20582|NCT02549755|B1|Baseline|Radiotherapy Treatment Monitoring of Hepatocellular Carcinoma|"All patients enrolled in the trial will undergo 3 PET/CT studies using 11C-acetate at the injected radiotracer. The patients will be imaged prior to their radiation therapy and at 1 and 3 months following the completion of their radiation therapy. They will also undergo an MRI scan of the liver at each of those time points.~11C-Acetate: The 11C-Acetate radiopharmaceutical will be administered intravenously at a dose of 20-40 mCi (0.74-1.5 GBq).~There will be a total of three 11C-acetate radiopharmaceutical administrations for each patient"
20583|NCT02549755|P1|Participant Flow|Main Arm|Enrolled patients are to undergo 3 acetate PET/CT examinations--the first within one month prior to radiotherapy, the second one month following, and the third three months following radiotherapy.
20584|NCT02549755|O1|Outcome|Main Arm|The single patient enrolled in the trial did not show tumor uptake on the initial scan and was thus dropped from the trial. The study was terminated in November of 2016.
20585|NCT02549755|E1|Reported Event|Main Arm|No adverse events occurred during the trial.
20586|NCT02549573|B3|Baseline|Total|Total of all reporting groups
20587|NCT02549573|B2|Baseline|Apokyn Treatment Withheld Before Physical Therapy|"APOKYN treatment withheld before the PT Intervention Visit. Subjects in the “APO-” group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No “rescue therapy” will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20588|NCT02549573|B1|Baseline|Apokyn Treatment Before Physical Therapy|"APOKYN treatment before the PT Intervention Visit. Subjects in the “APO+” group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~APOKYN: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20589|NCT02549573|P2|Participant Flow|Apokyn Treatment Withheld Before Physical Therapy|"APOKYN treatment withheld before the PT Intervention Visit. Subjects in the “APO-” group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No “rescue therapy” will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20694|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20695|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20590|NCT02549573|P1|Participant Flow|Apokyn Treatment Before Physical Therapy|"APOKYN treatment before the PT Intervention Visit. Subjects in the “APO+” group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~APOKYN: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20591|NCT02549573|O2|Outcome|Apokyn Treatment Withheld Before Physical Therapy|"APOKYN treatment withheld before the PT Intervention Visit. Subjects in the “APO-” group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No “rescue therapy” will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20592|NCT02549573|O1|Outcome|Apokyn Treatment Before Physical Therapy|"APOKYN treatment before the PT Intervention Visit. Subjects in the “APO+” group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~APOKYN: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20593|NCT02549573|O2|Outcome|Apokyn Treatment Withheld Before Physical Therapy|"APOKYN treatment withheld before the PT Intervention Visit. Subjects in the “APO-” group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No “rescue therapy” will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20594|NCT02549573|O1|Outcome|Apokyn Treatment Before Physical Therapy|"APOKYN treatment before the PT Intervention Visit. Subjects in the “APO+” group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~APOKYN: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20595|NCT02549573|O2|Outcome|Apokyn Treatment Withheld Before Physical Therapy|"APOKYN treatment withheld before the PT Intervention Visit. Subjects in the “APO-” group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No “rescue therapy” will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20596|NCT02549573|O1|Outcome|Apokyn Treatment Before Physical Therapy|"APOKYN treatment before the PT Intervention Visit. Subjects in the “APO+” group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~APOKYN: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20597|NCT02549573|O2|Outcome|Apokyn Treatment Withheld Before Physical Therapy|"APOKYN treatment withheld before the PT Intervention Visit. Subjects in the “APO-” group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No “rescue therapy” will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20598|NCT02549573|O1|Outcome|Apokyn Treatment Before Physical Therapy|"APOKYN treatment before the PT Intervention Visit. Subjects in the “APO+” group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~APOKYN: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20599|NCT02549573|O2|Outcome|Apokyn Treatment Withheld Before Physical Therapy|"APOKYN treatment withheld before the PT Intervention Visit. Subjects in the “APO-” group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No “rescue therapy” will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20600|NCT02549573|O1|Outcome|Apokyn Treatment Before Physical Therapy|"APOKYN treatment before the PT Intervention Visit. Subjects in the “APO+” group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~APOKYN: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20601|NCT02549573|O2|Outcome|Apokyn Treatment Withheld Before Physical Therapy|"APOKYN treatment withheld before the PT Intervention Visit. Subjects in the “APO-” group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No “rescue therapy” will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20602|NCT02549573|O1|Outcome|Apokyn Treatment Before Physical Therapy|"APOKYN treatment before the PT Intervention Visit. Subjects in the “APO+” group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~APOKYN: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20603|NCT02549573|O2|Outcome|Apokyn Treatment Withheld Before Physical Therapy|"APOKYN treatment withheld before the PT Intervention Visit. Subjects in the “APO-” group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No “rescue therapy” will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20604|NCT02549573|O1|Outcome|Apokyn Treatment Before Physical Therapy|"APOKYN treatment before the PT Intervention Visit. Subjects in the “APO+” group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~APOKYN: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20605|NCT02549573|O2|Outcome|Apokyn Treatment Withheld Before Physical Therapy|"APOKYN treatment withheld before the PT Intervention Visit. Subjects in the “APO-” group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No “rescue therapy” will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20606|NCT02549573|O1|Outcome|Apokyn Treatment Before Physical Therapy|"APOKYN treatment before the PT Intervention Visit. Subjects in the “APO+” group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~APOKYN: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20607|NCT02549573|O2|Outcome|Apokyn Treatment Withheld Before Physical Therapy|"APOKYN treatment withheld before the PT Intervention Visit. Subjects in the “APO-” group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No “rescue therapy” will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20608|NCT02549573|O1|Outcome|Apokyn Treatment Before Physical Therapy|"APOKYN treatment before the PT Intervention Visit. Subjects in the “APO+” group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~APOKYN: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20609|NCT02549573|O2|Outcome|Apokyn Treatment Withheld Before Physical Therapy|"APOKYN treatment withheld before the PT Intervention Visit. Subjects in the “APO-” group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No “rescue therapy” will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20610|NCT02549573|O1|Outcome|Apokyn Treatment Before Physical Therapy|"APOKYN treatment before the PT Intervention Visit. Subjects in the “APO+” group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~APOKYN: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20611|NCT02549573|O2|Outcome|Apokyn Treatment Withheld Before Physical Therapy|"APOKYN treatment withheld before the PT Intervention Visit. Subjects in the “APO-” group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No “rescue therapy” will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20612|NCT02549573|O1|Outcome|Apokyn Treatment Before Physical Therapy|"APOKYN treatment before the PT Intervention Visit. Subjects in the “APO+” group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~APOKYN: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20613|NCT02549573|O2|Outcome|Apokyn Treatment Withheld Before Physical Therapy|"APOKYN treatment withheld before the PT Intervention Visit. Subjects in the “APO-” group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No “rescue therapy” will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20614|NCT02549573|O1|Outcome|Apokyn Treatment Before Physical Therapy|"APOKYN treatment before the PT Intervention Visit. Subjects in the “APO+” group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~APOKYN: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20615|NCT02549573|O2|Outcome|Apokyn Treatment Withheld Before Physical Therapy|"APOKYN treatment withheld before the PT Intervention Visit. Subjects in the “APO-” group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No “rescue therapy” will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20616|NCT02549573|O1|Outcome|Apokyn Treatment Before Physical Therapy|"APOKYN treatment before the PT Intervention Visit. Subjects in the “APO+” group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~APOKYN: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20617|NCT02549573|O2|Outcome|Apokyn Treatment Withheld Before Physical Therapy|"APOKYN treatment withheld before the PT Intervention Visit. Subjects in the “APO-” group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No “rescue therapy” will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20618|NCT02549573|O1|Outcome|Apokyn Treatment Before Physical Therapy|"APOKYN treatment before the PT Intervention Visit. Subjects in the “APO+” group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~APOKYN: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20619|NCT02549573|O2|Outcome|Apokyn Treatment Withheld Before Physical Therapy|"APOKYN treatment withheld before the PT Intervention Visit. Subjects in the “APO-” group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No “rescue therapy” will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20620|NCT02549573|O1|Outcome|Apokyn Treatment Before Physical Therapy|"APOKYN treatment before the PT Intervention Visit. Subjects in the “APO+” group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~APOKYN: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20621|NCT02549573|O2|Outcome|Apokyn Treatment Withheld Before Physical Therapy|"APOKYN treatment withheld before the PT Intervention Visit. Subjects in the “APO-” group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No “rescue therapy” will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20622|NCT02549573|O1|Outcome|Apokyn Treatment Before Physical Therapy|"APOKYN treatment before the PT Intervention Visit. Subjects in the “APO+” group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~APOKYN: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20623|NCT02549573|O2|Outcome|Apokyn Treatment Withheld Before Physical Therapy|"APOKYN treatment withheld before the PT Intervention Visit. Subjects in the “APO-” group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No “rescue therapy” will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20624|NCT02549573|O1|Outcome|Apokyn Treatment Before Physical Therapy|"APOKYN treatment before the PT Intervention Visit. Subjects in the “APO+” group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~APOKYN: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20625|NCT02549573|O2|Outcome|Apokyn Treatment Withheld Before Physical Therapy|"APOKYN treatment withheld before the PT Intervention Visit. Subjects in the “APO-” group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No “rescue therapy” will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20626|NCT02549573|O1|Outcome|Apokyn Treatment Before Physical Therapy|"APOKYN treatment before the PT Intervention Visit. Subjects in the “APO+” group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~APOKYN: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20627|NCT02549573|O2|Outcome|Apokyn Treatment Withheld Before Physical Therapy|"APOKYN treatment withheld before the PT Intervention Visit. Subjects in the “APO-” group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No “rescue therapy” will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20628|NCT02549573|O1|Outcome|Apokyn Treatment Before Physical Therapy|"APOKYN treatment before the PT Intervention Visit. Subjects in the “APO+” group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~APOKYN: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20629|NCT02549573|E2|Reported Event|Apokyn Treatment Withheld Before Physical Therapy|"APOKYN treatment withheld before the PT Intervention Visit. Subjects in the “APO-” group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No “rescue therapy” will be allowed during the PT Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20630|NCT02549573|E1|Reported Event|Apokyn Treatment Before Physical Therapy|"APOKYN treatment before the PT Intervention Visit. Subjects in the “APO+” group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~APOKYN: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~Physical Therapy: All subjects will participate in a standardized PT intervention"
20631|NCT02549027|B1|Baseline|All Study Participants|
20632|NCT02549027|P6|Participant Flow|Placebo (Period 5)|Participants in this arm had completed the first 4 study periods, and were randomized to receive a single dose of placebo in Period 5.
20633|NCT02549027|P5|Participant Flow|MK-6096 20 mg (Period 5)|Participants in this arm had completed the first 4 study periods, and were randomized to receive a single dose of 20 mg of MK-6096 in Period 5.
20634|NCT02549027|P4|Participant Flow|MK-1064: 250 mg→120 mg→50 mg→Placebo (Period 1-4)|Period 1 - single dose of 250 mg MK-1064, Period 2 - single dose of 120 mg MK-1064, Period 3 - single dose of 50 mg MK-1064, Period 4 - single dose of placebo.
20635|NCT02549027|P3|Participant Flow|MK-1064: 120 mg→Placebo→250 mg→50 mg (Period 1-4)|Period 1 - single dose of 120 mg MK-1064, Period 2 - single dose of placebo, Period 3 - single dose of 250 mg MK-1064, Period 4 - single dose of 50 mg MK-1064.
20636|NCT02549027|P2|Participant Flow|MK-1064: Placebo→50 mg→120 mg→250 mg (Period 1-4)|Period 1 - single dose of placebo, Period 2 - single dose of 50 mg MK-1064, Period 3 - single dose of 120 mg MK-1064, Period 4 - single dose of 250 mg MK-1064.
20637|NCT02549027|P1|Participant Flow|MK-1064: 50 mg→250 mg→Placebo→120 mg (Period 1-4)|Period 1 - single dose of 50 mg MK-1064, Period 2 - single dose of 250 mg MK-1064, Period 3 - single dose of placebo, Period 4 - single dose of 120 mg MK-1064.
20638|NCT02549027|O2|Outcome|Placebo|Single dose of placebo
20639|NCT02549027|O1|Outcome|MK-6096 20 mg|Single dose of 20 mg MK-6096
20640|NCT02549027|O4|Outcome|Placebo|Single dose of placebo
20641|NCT02549027|O3|Outcome|MK-1064 250 mg|Single dose of 250 mg MK-1064
20642|NCT02549027|O2|Outcome|MK-1064 120 mg|Single dose of 120 mg MK-1064
20643|NCT02549027|O1|Outcome|MK-1064 50 mg|Single dose of 50 mg MK-1064
20644|NCT02549027|O2|Outcome|Placebo|Single dose of placebo
20645|NCT02549027|O1|Outcome|MK-6096 20 mg|Single dose of 20 mg MK-6096
20646|NCT02549027|O4|Outcome|Placebo|Single dose of placebo
20647|NCT02549027|O3|Outcome|MK-1064 250 mg|Single dose of 250 mg MK-1064
20648|NCT02549027|O2|Outcome|MK-1064 120 mg|Single dose of 120 mg MK-1064
20649|NCT02549027|O1|Outcome|MK-1064 50 mg|Single dose of 50 mg MK-1064
20650|NCT02549027|O5|Outcome|Placebo|Single dose of placebo
20651|NCT02549027|O4|Outcome|MK-6096 20 mg|Single dose of 20 mg MK-6096
20652|NCT02549027|O3|Outcome|MK-1064 250 mg|Single dose of 250 mg MK-1064
20653|NCT02549027|O2|Outcome|MK-1064 120 mg|Single dose of 120 mg MK-1064
20654|NCT02549027|O1|Outcome|MK-1064 50 mg|Single dose of 50 mg MK-1064
20655|NCT02549027|O5|Outcome|Placebo|Single dose of placebo
20656|NCT02549027|O4|Outcome|MK-6096 20 mg|Single dose of 20 mg MK-6096
20657|NCT02549027|O3|Outcome|MK-1064 250 mg|Single dose of 250 mg MK-1064
20658|NCT02549027|O2|Outcome|MK-1064 120 mg|Single dose of 120 mg MK-1064
20659|NCT02549027|O1|Outcome|MK-1064 50 mg|Single dose of 50 mg MK-1064
20660|NCT02549027|O2|Outcome|Placebo|Single dose of placebo
20661|NCT02549027|O1|Outcome|MK-6096 20 mg|Single dose of 20 mg MK-6096
20662|NCT02549027|O4|Outcome|Placebo|Single dose of placebo
20663|NCT02549027|O3|Outcome|MK-1064 250 mg|Single dose of 250 mg MK-1064
20664|NCT02549027|O2|Outcome|MK-1064 120 mg|Single dose of 120 mg MK-1064
20665|NCT02549027|O1|Outcome|MK-1064 50 mg|Single dose of 50 mg MK-1064
20666|NCT02549027|E5|Reported Event|Placebo|Single dose of placebo
20667|NCT02549027|E4|Reported Event|MK-6096 20 mg|Single dose of 20 mg MK-6096
20672|NCT02549014|B2|Baseline|Panel B: MK-1064|Panel B: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 10, 50, 150 and 250 mg over Periods 1-4, in the morning with participants in fasted condition. In Period 5, a single MK-1064 dose of 50 mg or placebo was administered to participants in the evening after a 4-hour fast. Dosing periods alternated with Panel A. There was to be a minimum 7 day wash-out between treatment periods for any given participant.
20673|NCT02549014|B1|Baseline|Panel A: MK-1064|Panel A: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 5, 25, 100 and 200 mg over Periods 1-4, in the morning with participants in a fasted condition. In Period 5, a single MK-1064 dose of 25 mg or placebo was administered to participants in the morning following a standard high-fat breakfast. Dosing periods alternated with Panel B. There was to be a minimum 7-day washout between treatment periods for any given participant.
20674|NCT02549014|P2|Participant Flow|Panel B: MK-1064|Panel B: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 10, 50, 150 and 250 mg over Periods 1-4, in the morning with participants in fasted condition. In Period 5, a single MK-1064 dose of 50 mg or placebo was administered to participants in the evening after a 4-hour fast. Dosing periods alternated with Panel A. There was to be a minimum 7 day wash-out between treatment periods for any given participant.
20675|NCT02549014|P1|Participant Flow|Panel A: MK-1064|Panel A: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 5, 25, 100 and 200 mg over Periods 1-4, in the morning with participants in a fasted condition. In Period 5, a single MK-1064 dose of 25 mg or placebo was administered to participants in the morning following a standard high-fat breakfast. Dosing periods alternated with Panel B. There was to be a minimum 7-day washout between treatment periods for any given participant.
20676|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
20677|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
20678|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
20679|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20680|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20681|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20682|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20683|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20684|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20685|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20686|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20687|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
20688|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
20689|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
20690|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20691|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20989|NCT02547714|E2|Reported Event|Induction Period - Secukinumab (AIN457)|During the induction period, participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, and 4.
20696|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20697|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20698|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
20699|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
20700|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
20701|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20702|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20703|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20704|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20705|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20706|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20707|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20708|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20709|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
20710|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
20711|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
20712|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20713|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20714|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20715|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20716|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20717|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20718|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20719|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20720|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
20721|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
20722|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
20723|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20724|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20725|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20726|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20727|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20728|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20729|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20730|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20731|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
20732|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
20733|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
20734|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20735|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20736|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20737|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20738|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20739|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20740|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20741|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20742|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
20743|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
20744|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
20745|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20746|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20747|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20748|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
24803|NCT02498652|O3|Outcome|Treatment A2b|Allopurinol 600 mg (300 mg bid)
20749|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20750|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20751|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20752|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20753|NCT02549014|E11|Reported Event|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
20754|NCT02549014|E10|Reported Event|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
20755|NCT02549014|E9|Reported Event|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
20756|NCT02549014|E8|Reported Event|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20757|NCT02549014|E7|Reported Event|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20758|NCT02549014|E6|Reported Event|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20759|NCT02549014|E5|Reported Event|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20760|NCT02549014|E4|Reported Event|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20761|NCT02549014|E3|Reported Event|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20762|NCT02549014|E2|Reported Event|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20763|NCT02549014|E1|Reported Event|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
20764|NCT02548455|B1|Baseline|Treatment|"Left Ventricular Lead model Quartet 1457Q~Left Ventricular Lead"
20765|NCT02548455|P1|Participant Flow|Treatment|"Left Ventricular Lead model Quartet 1457Q~Left Ventricular Lead"
20766|NCT02548455|O1|Outcome|Treatment|Subjects implanted with the Quartet 1457Q left ventricular lead
20767|NCT02548455|E1|Reported Event|Treatment|Subjects implanted with the Quartet 1457Q left ventricular lead
20768|NCT02548156|B1|Baseline|Overall Study|All the participants randomized in this study.
20769|NCT02548156|P6|Participant Flow|Sequence 6: Reference/Comparator/Test: Dentifrice|Firstly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; secondly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
20770|NCT02548156|P5|Participant Flow|Sequence 5: Reference/Test/Comparator: Dentifrice|Firstly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; secondly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
20771|NCT02548156|P4|Participant Flow|Sequence 4: Comparator/Reference/Test: Dentifrice|Firstly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; thirdly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
20772|NCT02548156|P3|Participant Flow|Sequence 3: Comparator/Test/Reference: Dentifrice|Firstly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
20990|NCT02547714|E1|Reported Event|Entire Period - Secukinumab (AIN457)|Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
20773|NCT02548156|P2|Participant Flow|Sequence 2: Test/Reference/Comparator: Dentifrice|Firstly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; thirdly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
20774|NCT02548156|P1|Participant Flow|Sequence 1: Test/Comparator/Reference: Dentifrice|Firstly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
20775|NCT02548156|O3|Outcome|Comparator Dentifrice|1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
20776|NCT02548156|O2|Outcome|Reference Dentifrice|1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
20777|NCT02548156|O1|Outcome|Test Dentifrice|1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
20778|NCT02548156|O3|Outcome|Comparator Dentifrice|1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
20779|NCT02548156|O2|Outcome|Reference Dentifrice|1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
20780|NCT02548156|O1|Outcome|Test Dentifrice|1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
20781|NCT02548156|O3|Outcome|Comparator Dentifrice|1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
20782|NCT02548156|O2|Outcome|Reference Dentifrice|1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
20783|NCT02548156|O1|Outcome|Test Dentifrice|1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
20784|NCT02548156|O3|Outcome|Comparator Dentifrice|1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
20785|NCT02548156|O2|Outcome|Reference Dentifrice|1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
20786|NCT02548156|O1|Outcome|Test Dentifrice|1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
20787|NCT02548156|E3|Reported Event|Comparator Dentifrice|1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
20788|NCT02548156|E2|Reported Event|Reference Dentifrice|1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
20789|NCT02548156|E1|Reported Event|Test Dentifrice|1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
20790|NCT02548078|B3|Baseline|Total|Total of all reporting groups
20791|NCT02548078|B2|Baseline|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20792|NCT02548078|B1|Baseline|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20793|NCT02548078|P2|Participant Flow|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20794|NCT02548078|P1|Participant Flow|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20795|NCT02548078|O6|Outcome|Nimenrix+GSK3390107A 1-5YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20796|NCT02548078|O5|Outcome|GSK3390107A+Nimenrix 1-5YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20797|NCT02548078|O4|Outcome|Nimenrix+GSK3390107A 6-12YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20798|NCT02548078|O3|Outcome|GSK3390107A+Nimenrix 6-12YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20799|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A 13-17YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
20800|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix 13-17YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
20801|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
21120|NCT02545543|B3|Baseline|Total|Total of all reporting groups
21511|NCT02540772|E2|Reported Event|No Treatment|Patients in the control group only performed the baselines.
20802|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20803|NCT02548078|O6|Outcome|Nimenrix+GSK3390107A 1-5YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20804|NCT02548078|O5|Outcome|GSK3390107A+Nimenrix 1-5YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20805|NCT02548078|O4|Outcome|Nimenrix+GSK3390107A 6-12YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20806|NCT02548078|O3|Outcome|GSK3390107A+Nimenrix 6-12YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20807|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A 13-17YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
20808|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix 13-17YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
20809|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20810|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20811|NCT02548078|O6|Outcome|Nimenrix+GSK3390107A 1-5YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20812|NCT02548078|O5|Outcome|GSK3390107A+Nimenrix 1-5YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20813|NCT02548078|O4|Outcome|Nimenrix+GSK3390107A 6-12YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20814|NCT02548078|O3|Outcome|GSK3390107A+Nimenrix 6-12YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20815|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A 13-17YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
20816|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix 13-17YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
20817|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20818|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20819|NCT02548078|O6|Outcome|Nimenrix+GSK3390107A 1-5YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20820|NCT02548078|O5|Outcome|GSK3390107A+Nimenrix 1-5YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20821|NCT02548078|O4|Outcome|Nimenrix+GSK3390107A 6-12YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20822|NCT02548078|O3|Outcome|GSK3390107A+Nimenrix 6-12YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20823|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A 13-17YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
20824|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix 13-17YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
21599|NCT02540265|E1|Reported Event|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.~N1539"
20825|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20826|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20827|NCT02548078|O6|Outcome|Nimenrix+GSK3390107A 1-5YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20828|NCT02548078|O5|Outcome|GSK3390107A+Nimenrix 1-5YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20829|NCT02548078|O4|Outcome|Nimenrix+GSK3390107A 6-12YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20830|NCT02548078|O3|Outcome|GSK3390107A+Nimenrix 6-12YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20831|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A 13-17YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
20832|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix 13-17YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
20833|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20834|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20835|NCT02548078|O6|Outcome|Nimenrix+GSK3390107A 1-5YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20836|NCT02548078|O5|Outcome|GSK3390107A+Nimenrix 1-5YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20837|NCT02548078|O4|Outcome|Nimenrix+GSK3390107A 6-12YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20838|NCT02548078|O3|Outcome|GSK3390107A+Nimenrix 6-12YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20839|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A 13-17YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
20840|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix 13-17YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
20841|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20842|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20843|NCT02548078|O6|Outcome|Nimenrix+GSK3390107A 1-5YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20844|NCT02548078|O5|Outcome|GSK3390107A+Nimenrix 1-5YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20845|NCT02548078|O4|Outcome|Nimenrix+GSK3390107A 6-12YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20846|NCT02548078|O3|Outcome|GSK3390107A+Nimenrix 6-12YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20847|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A 13-17YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
21335|NCT02542761|E2|Reported Event|Fiberglass Prosthetic Foot (FPF)|The Rush87 foot is a fiberglass composite energy storage and return prosthetic foot.
20848|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix 13-17YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
20849|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20850|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20851|NCT02548078|O6|Outcome|Nimenrix+GSK3390107A 1-5YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20852|NCT02548078|O5|Outcome|GSK3390107A+Nimenrix 1-5YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20853|NCT02548078|O4|Outcome|Nimenrix+GSK3390107A 6-12YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20854|NCT02548078|O3|Outcome|GSK3390107A+Nimenrix 6-12YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20855|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A 13-17YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
20856|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix 13-17YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
20857|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20858|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20859|NCT02548078|O6|Outcome|Nimenrix+GSK3390107A 1-5YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20860|NCT02548078|O5|Outcome|GSK3390107A+Nimenrix 1-5YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20861|NCT02548078|O4|Outcome|Nimenrix+GSK3390107A 6-12YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20862|NCT02548078|O3|Outcome|GSK3390107A+Nimenrix 6-12YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20863|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A 13-17YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
20864|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix 13-17YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
20865|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20866|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20867|NCT02548078|O6|Outcome|Nimenrix+GSK3390107A 1-5YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20868|NCT02548078|O5|Outcome|GSK3390107A+Nimenrix 1-5YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20869|NCT02548078|O4|Outcome|Nimenrix+GSK3390107A 6-12YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20870|NCT02548078|O3|Outcome|GSK3390107A+Nimenrix 6-12YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
21663|NCT02539797|E2|Reported Event|tDCS Cathodal Stimulation|"cathodal stimulation~tDCS: comparing anodal, cathodal, and sham tDCS"
20871|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A 13-17YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
20872|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix 13-17YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
20873|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20874|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20875|NCT02548078|O6|Outcome|Nimenrix+GSK3390107A 1-5YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20876|NCT02548078|O5|Outcome|GSK3390107A+Nimenrix 1-5YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20877|NCT02548078|O4|Outcome|Nimenrix+GSK3390107A 6-12YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20878|NCT02548078|O3|Outcome|GSK3390107A+Nimenrix 6-12YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20879|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A 13-17YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
20880|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix 13-17YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
20881|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20882|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20883|NCT02548078|O6|Outcome|Nimenrix+GSK3390107A 1-5YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20884|NCT02548078|O5|Outcome|GSK3390107A+Nimenrix 1-5YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20885|NCT02548078|O4|Outcome|Nimenrix+GSK3390107A 6-12YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20886|NCT02548078|O3|Outcome|GSK3390107A+Nimenrix 6-12YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20887|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A 13-17YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
20888|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix 13-17YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
20889|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20890|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20891|NCT02548078|O6|Outcome|Nimenrix+GSK3390107A 1-5YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20892|NCT02548078|O5|Outcome|GSK3390107A+Nimenrix 1-5YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20893|NCT02548078|O4|Outcome|Nimenrix+GSK3390107A 6-12YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
21664|NCT02539797|E1|Reported Event|tDCS Anodal Stimulation|"anodal stimulation~tDCS: comparing anodal, cathodal, and sham tDCS"
20894|NCT02548078|O3|Outcome|GSK3390107A+Nimenrix 6-12YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20895|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A 13-17YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
20896|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix 13-17YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
20897|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20898|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20899|NCT02548078|O6|Outcome|Nimenrix+GSK3390107A 1-5YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20900|NCT02548078|O5|Outcome|GSK3390107A+Nimenrix 1-5YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20901|NCT02548078|O4|Outcome|Nimenrix+GSK3390107A 6-12YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20902|NCT02548078|O3|Outcome|GSK3390107A+Nimenrix 6-12YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20903|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A 13-17YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
20904|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix 13-17YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
20905|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20906|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20907|NCT02548078|O6|Outcome|Nimenrix+GSK3390107A 1-5YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20908|NCT02548078|O5|Outcome|GSK3390107A+Nimenrix 1-5YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20909|NCT02548078|O4|Outcome|Nimenrix+GSK3390107A 6-12YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20910|NCT02548078|O3|Outcome|GSK3390107A+Nimenrix 6-12YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20911|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A 13-17YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
20912|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix 13-17YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
20913|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20914|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20915|NCT02548078|O6|Outcome|Nimenrix+GSK3390107A 1-5YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20916|NCT02548078|O5|Outcome|GSK3390107A+Nimenrix 1-5YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
21665|NCT02539134|B7|Baseline|Total|Total of all reporting groups
24804|NCT02498652|O2|Outcome|Treatment A2q|Allopurinol 600 mg qd
20917|NCT02548078|O4|Outcome|Nimenrix+GSK3390107A 6-12YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20918|NCT02548078|O3|Outcome|GSK3390107A+Nimenrix 6-12YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20919|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A 13-17YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
20920|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix 13-17YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
20921|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20922|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20923|NCT02548078|O6|Outcome|Nimenrix+GSK3390107A 1-5YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20924|NCT02548078|O5|Outcome|GSK3390107A+Nimenrix 1-5YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20925|NCT02548078|O4|Outcome|Nimenrix+GSK3390107A 6-12YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20926|NCT02548078|O3|Outcome|GSK3390107A+Nimenrix 6-12YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20927|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A 13-17YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
20928|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix 13-17YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
20929|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20930|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20931|NCT02548078|O6|Outcome|Nimenrix+GSK3390107A 1-5YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20932|NCT02548078|O5|Outcome|GSK3390107A+Nimenrix 1-5YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20933|NCT02548078|O4|Outcome|Nimenrix+GSK3390107A 6-12YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20934|NCT02548078|O3|Outcome|GSK3390107A+Nimenrix 6-12YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20935|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A 13-17YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
20936|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix 13-17YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
20937|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20938|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20939|NCT02548078|O6|Outcome|Nimenrix+GSK3390107A 1-5YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
21666|NCT02539134|B6|Baseline|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
20940|NCT02548078|O5|Outcome|GSK3390107A+Nimenrix 1-5YOAGroup|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20941|NCT02548078|O4|Outcome|Nimenrix+GSK3390107A 6-12YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20942|NCT02548078|O3|Outcome|GSK3390107A+Nimenrix 6-12YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20943|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A 13-17YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
20944|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix 13-17YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
20945|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20946|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20947|NCT02548078|O6|Outcome|Nimenrix+GSK3390107A 1-5YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20948|NCT02548078|O5|Outcome|GSK3390107A+Nimenrix 1-5YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20949|NCT02548078|O4|Outcome|Nimenrix+GSK3390107A 6-12YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20950|NCT02548078|O3|Outcome|GSK3390107A+Nimenrix 6-12YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20951|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A 13-17YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
20952|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix 13-17YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
20953|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20954|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20955|NCT02548078|O6|Outcome|Nimenrix+GSK3390107A 1-5YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20956|NCT02548078|O5|Outcome|GSK3390107A+Nimenrix 1-5YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20957|NCT02548078|O4|Outcome|Nimenrix+GSK3390107A 6-12YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20958|NCT02548078|O3|Outcome|GSK3390107A+Nimenrix 6-12YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20959|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A 13-17YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
20960|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix 13-17YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
20961|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20962|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
21153|NCT02545101|P1|Participant Flow|Tolvaptan|Adult patients who received at least 2 doses of tolvaptan for the treatment of one occurrence of hyponatraemia secondary to SIADH.
20963|NCT02548078|O6|Outcome|Nimenrix+GSK3390107A 1-5YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20964|NCT02548078|O5|Outcome|GSK3390107A+Nimenrix 1-5YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20965|NCT02548078|O4|Outcome|Nimenrix+GSK3390107A 6-12YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20966|NCT02548078|O3|Outcome|GSK3390107A+Nimenrix 6-12YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20967|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A 13-17YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
20968|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix 13-17YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
20969|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20970|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20971|NCT02548078|O6|Outcome|Nimenrix+GSK3390107A 1-5YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20972|NCT02548078|O5|Outcome|GSK3390107A+Nimenrix 1-5YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20973|NCT02548078|O4|Outcome|Nimenrix+GSK3390107A 6-12YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
20974|NCT02548078|O3|Outcome|GSK3390107A+Nimenrix 6-12YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
20975|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A 13-17YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
20976|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix 13-17YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
20977|NCT02548078|O2|Outcome|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20978|NCT02548078|O1|Outcome|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20979|NCT02548078|E2|Reported Event|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20980|NCT02548078|E1|Reported Event|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
20981|NCT02547714|B1|Baseline|Secukinumab (AIN457) 300 mg|Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
20982|NCT02547714|P1|Participant Flow|Secukinumab (AIN457) 300 mg|Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
20983|NCT02547714|O1|Outcome|Secukinumab (AIN457) 300 mg|Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
20984|NCT02547714|O1|Outcome|Secukinumab (AIN457) 300 mg|Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
20985|NCT02547714|O1|Outcome|Secukinumab (AIN457) 300 mg|Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
20986|NCT02547714|O1|Outcome|Secukinumab (AIN457) 300 mg|Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
20987|NCT02547714|O1|Outcome|Secukinumab (AIN457) 300 mg|Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
20988|NCT02547714|O1|Outcome|Secukinumab (AIN457) 300 mg|Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
21667|NCT02539134|B5|Baseline|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
20991|NCT02547454|B1|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
20992|NCT02547454|P1|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with chronic kidney disease (CKD), who did not require dialysis, received methoxy polyethylene glycol-epoetin beta (Mircera) either intravenously (IV) or subcutaneously (SC), as per routine clinical practice, and were followed for approximately 36 months.
20993|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
20994|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
20995|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
20996|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
20997|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
20998|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
20999|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
21000|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
21001|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
21002|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
21003|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
21004|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
21005|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
21006|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
21007|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
21008|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
21009|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
21010|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
21011|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
21012|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
21013|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
21014|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
21015|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
21016|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
21154|NCT02545101|O1|Outcome|Tolvaptan|Adult patients who received at least 2 doses of tolvaptan for the treatment of one occurrence of hyponatraemia secondary to SIADH.
21017|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
21018|NCT02547454|E1|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
21019|NCT02547064|B3|Baseline|Total|Total of all reporting groups
21020|NCT02547064|B2|Baseline|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
21021|NCT02547064|B1|Baseline|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
21022|NCT02547064|P2|Participant Flow|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
21023|NCT02547064|P1|Participant Flow|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
21024|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
21025|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
21026|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
21027|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
21028|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
21029|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
21030|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
21031|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
21032|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
21033|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
21034|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
21035|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
21036|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
21037|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
21038|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
21039|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
21040|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
21041|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
21042|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
21043|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
21044|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
21045|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
21046|NCT02547064|E2|Reported Event|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
21047|NCT02547064|E1|Reported Event|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
21048|NCT02546986|B3|Baseline|Total|Total of all reporting groups
21049|NCT02546986|B2|Baseline|Placebo and Pembrolizumab (PBO + PBZ)|Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
21155|NCT02545101|O1|Outcome|Tolvaptan|Adult patients who received at least 2 doses of tolvaptan for the treatment of one occurrence of hyponatraemia secondary to SIADH.
21050|NCT02546986|B1|Baseline|CC-486 and Pembrolizumab (CC-486 + PBZ)|Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
21051|NCT02546986|P2|Participant Flow|Placebo and Pembrolizumab (PBO + PBZ)|Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
21052|NCT02546986|P1|Participant Flow|CC-486 and Pembrolizumab (CC-486 + PBZ)|Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
21053|NCT02546986|O1|Outcome|CC-486 and Pembrolizumab (CC-486 + PBZ)|Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
21054|NCT02546986|O1|Outcome|CC-486 and Pembrolizumab (CC-486 + PBZ)|Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
21055|NCT02546986|O1|Outcome|CC-486 and Pembrolizumab (CC-486 + PBZ)|Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
21056|NCT02546986|O1|Outcome|CC-486 and Pembrolizumab (CC-486 + PBZ)|Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
21057|NCT02546986|O1|Outcome|CC-486 and Pembrolizumab (CC-486 + PBZ)|Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
21058|NCT02546986|O1|Outcome|CC-486 and Pembrolizumab (CC-486 + PBZ)|Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
21059|NCT02546986|O1|Outcome|CC-486 and Pembrolizumab (CC-486 + PBZ)|Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
21060|NCT02546986|O2|Outcome|Placebo and Pembrolizumab (PBO + PBZ)|Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
21061|NCT02546986|O1|Outcome|CC-486 and Pembrolizumab (CC-486 + PBZ)|Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
21062|NCT02546986|O2|Outcome|Placebo and Pembrolizumab (PBO + PBZ)|Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
21063|NCT02546986|O1|Outcome|CC-486 and Pembrolizumab (CC-486 + PBZ)|Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
21064|NCT02546986|O2|Outcome|Placebo and Pembrolizumab (PBO + PBZ)|Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
21065|NCT02546986|O1|Outcome|CC-486 and Pembrolizumab (CC-486 + PBZ)|Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
21156|NCT02545101|O1|Outcome|Tolvaptan|Adult patients who received at least 2 doses of tolvaptan for the treatment of one occurrence of hyponatraemia secondary to SIADH.
21066|NCT02546986|O2|Outcome|Placebo and Pembrolizumab (PBO + PBZ)|Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
21067|NCT02546986|O1|Outcome|CC-486 and Pembrolizumab (CC-486 + PBZ)|Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
21068|NCT02546986|O2|Outcome|Placebo and Pembrolizumab (PBO + PBZ)|Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
21069|NCT02546986|O1|Outcome|CC-486 and Pembrolizumab (CC-486 + PBZ)|Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
21070|NCT02546986|O2|Outcome|Placebo and Pembrolizumab (PBO + PBZ)|Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
21071|NCT02546986|O1|Outcome|CC-486 and Pembrolizumab (CC-486 + PBZ)|Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
21072|NCT02546986|E2|Reported Event|Pembrolizumab+Placebo|Participants received placebo tablets orally on days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on day 1 of a 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
21073|NCT02546986|E1|Reported Event|CC-486+Pembrolizumab|Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
21074|NCT02546609|B4|Baseline|Total|Total of all reporting groups
21075|NCT02546609|B3|Baseline|Leu Met Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 1.0 mg of sildenafil.~Sildenafil 1.0 mg: Sildenafil 1.0 mg~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID"
21076|NCT02546609|B2|Baseline|Leu Met Sil 0.5mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 0.5 mg of sildenafil.~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID~Sildenafil Citrate 0.5 mg: Sildenafil 0.5 mg BID"
21077|NCT02546609|B1|Baseline|Placebo|"3 capsules BID containing 99% Avicel PH302 and 1% magnesium stearate (w/w)~Placebo: Placebo"
21078|NCT02546609|P3|Participant Flow|Leu Met Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 1.0 mg of sildenafil.~Sildenafil 1.0 mg: Sildenafil 1.0 mg~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID"
21079|NCT02546609|P2|Participant Flow|Leu Met Sil 0.5mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 0.5 mg of sildenafil.~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID~Sildenafil Citrate 0.5 mg: Sildenafil 0.5 mg BID"
21080|NCT02546609|P1|Participant Flow|Placebo|"3 capsules BID containing 99% Avicel PH302 and 1% magnesium stearate (w/w)~Placebo: Placebo"
21081|NCT02546609|O3|Outcome|Leu Met Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 1.0 mg of sildenafil.~Sildenafil 1.0 mg: Sildenafil 1.0 mg~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID"
21082|NCT02546609|O2|Outcome|Leu Met Sil 0.5mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 0.5 mg of sildenafil.~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID~Sildenafil Citrate 0.5 mg: Sildenafil 0.5 mg BID"
21083|NCT02546609|O1|Outcome|Placebo|"3 capsules BID containing 99% Avicel PH302 and 1% magnesium stearate (w/w)~Placebo: Placebo"
21084|NCT02546609|O3|Outcome|Leu Met Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 1.0 mg of sildenafil.~Sildenafil 1.0 mg: Sildenafil 1.0 mg~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID"
21085|NCT02546609|O2|Outcome|Leu Met Sil 0.5mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 0.5 mg of sildenafil.~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID~Sildenafil Citrate 0.5 mg: Sildenafil 0.5 mg BID"
21086|NCT02546609|O1|Outcome|Placebo|"3 capsules BID containing 99% Avicel PH302 and 1% magnesium stearate (w/w)~Placebo: Placebo"
21087|NCT02546609|O3|Outcome|Leu Met Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 1.0 mg of sildenafil.~Sildenafil 1.0 mg: Sildenafil 1.0 mg~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID"
21088|NCT02546609|O2|Outcome|Leu Met Sil 0.5mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 0.5 mg of sildenafil.~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID~Sildenafil Citrate 0.5 mg: Sildenafil 0.5 mg BID"
21089|NCT02546609|O1|Outcome|Placebo|"3 capsules BID containing 99% Avicel PH302 and 1% magnesium stearate (w/w)~Placebo: Placebo"
24805|NCT02498652|O1|Outcome|Treatment A1|Allopurinol 300 mg qd
21090|NCT02546609|O3|Outcome|Leu Met Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 1.0 mg of sildenafil.~Sildenafil 1.0 mg: Sildenafil 1.0 mg~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID"
21091|NCT02546609|O2|Outcome|Leu Met Sil 0.5mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 0.5 mg of sildenafil.~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID~Sildenafil Citrate 0.5 mg: Sildenafil 0.5 mg BID"
21092|NCT02546609|O1|Outcome|Placebo|"3 capsules BID containing 99% Avicel PH302 and 1% magnesium stearate (w/w)~Placebo: Placebo"
21093|NCT02546609|O3|Outcome|Leu Met Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 1.0 mg of sildenafil.~Sildenafil 1.0 mg: Sildenafil 1.0 mg~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID"
21094|NCT02546609|O2|Outcome|Leu Met Sil 0.5mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 0.5 mg of sildenafil.~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID~Sildenafil Citrate 0.5 mg: Sildenafil 0.5 mg BID"
21095|NCT02546609|O1|Outcome|Placebo|"3 capsules BID containing 99% Avicel PH302 and 1% magnesium stearate (w/w)~Placebo: Placebo"
21096|NCT02546609|O3|Outcome|Leu Met Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 1.0 mg of sildenafil.~Sildenafil 1.0 mg: Sildenafil 1.0 mg~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID"
21097|NCT02546609|O2|Outcome|Leu Met Sil 0.5mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 0.5 mg of sildenafil.~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID~Sildenafil Citrate 0.5 mg: Sildenafil 0.5 mg BID"
21098|NCT02546609|O1|Outcome|Placebo|"3 capsules BID containing 99% Avicel PH302 and 1% magnesium stearate (w/w)~Placebo: Placebo"
21099|NCT02546609|O3|Outcome|Leu Met Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 1.0 mg of sildenafil.~Sildenafil 1.0 mg: Sildenafil 1.0 mg~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID"
21100|NCT02546609|O2|Outcome|Leu Met Sil 0.5mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 0.5 mg of sildenafil.~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID~Sildenafil Citrate 0.5 mg: Sildenafil 0.5 mg BID"
21101|NCT02546609|O1|Outcome|Placebo|"3 capsules BID containing 99% Avicel PH302 and 1% magnesium stearate (w/w)~Placebo: Placebo"
21102|NCT02546609|O3|Outcome|Leu Met Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 1.0 mg of sildenafil.~Sildenafil 1.0 mg: Sildenafil 1.0 mg~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID"
21103|NCT02546609|O2|Outcome|Leu Met Sil 0.5mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 0.5 mg of sildenafil.~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID~Sildenafil Citrate 0.5 mg: Sildenafil 0.5 mg BID"
21104|NCT02546609|O1|Outcome|Placebo|"3 capsules BID containing 99% Avicel PH302 and 1% magnesium stearate (w/w)~Placebo: Placebo"
21105|NCT02546609|O3|Outcome|Leu Met Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 1.0 mg of sildenafil.~Sildenafil 1.0 mg: Sildenafil 1.0 mg~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID"
21106|NCT02546609|O2|Outcome|Leu Met Sil 0.5mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 0.5 mg of sildenafil.~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID~Sildenafil Citrate 0.5 mg: Sildenafil 0.5 mg BID"
21107|NCT02546609|O1|Outcome|Placebo|"3 capsules BID containing 99% Avicel PH302 and 1% magnesium stearate (w/w)~Placebo: Placebo"
21108|NCT02546609|O3|Outcome|Leu Met Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 1.0 mg of sildenafil.~Sildenafil 1.0 mg: Sildenafil 1.0 mg~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID"
21109|NCT02546609|O2|Outcome|Leu Met Sil 0.5mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 0.5 mg of sildenafil.~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID~Sildenafil Citrate 0.5 mg: Sildenafil 0.5 mg BID"
21110|NCT02546609|O1|Outcome|Placebo|"3 capsules BID containing 99% Avicel PH302 and 1% magnesium stearate (w/w)~Placebo: Placebo"
21111|NCT02546609|O3|Outcome|Leu Met Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 1.0 mg of sildenafil.~Sildenafil 1.0 mg: Sildenafil 1.0 mg~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID"
21112|NCT02546609|O2|Outcome|Leu Met Sil 0.5mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 0.5 mg of sildenafil.~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID~Sildenafil Citrate 0.5 mg: Sildenafil 0.5 mg BID"
21113|NCT02546609|O1|Outcome|Placebo|"3 capsules BID containing 99% Avicel PH302 and 1% magnesium stearate (w/w)~Placebo: Placebo"
21114|NCT02546609|O3|Outcome|Leu Met Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 1.0 mg of sildenafil.~Sildenafil 1.0 mg: Sildenafil 1.0 mg~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID"
21115|NCT02546609|O2|Outcome|Leu Met Sil 0.5mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 0.5 mg of sildenafil.~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID~Sildenafil Citrate 0.5 mg: Sildenafil 0.5 mg BID"
21116|NCT02546609|O1|Outcome|Placebo|"3 capsules BID containing 99% Avicel PH302 and 1% magnesium stearate (w/w)~Placebo: Placebo"
21117|NCT02546609|E3|Reported Event|Leu Met Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 1.0 mg of sildenafil.~Sildenafil 1.0 mg: Sildenafil 1.0 mg~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID"
21118|NCT02546609|E2|Reported Event|Leu Met Sil 0.5mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 0.5 mg of sildenafil.~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID~Sildenafil Citrate 0.5 mg: Sildenafil 0.5 mg BID"
21119|NCT02546609|E1|Reported Event|Placebo|"3 capsules BID containing 99% Avicel PH302 and 1% magnesium stearate (w/w)~Placebo: Placebo"
21121|NCT02545543|B2|Baseline|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
21122|NCT02545543|B1|Baseline|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
21123|NCT02545543|P2|Participant Flow|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
21124|NCT02545543|P1|Participant Flow|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
21125|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
21126|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
21127|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
21128|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
21129|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
21130|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
21157|NCT02545101|O1|Outcome|Tolvaptan|Adult patients who received at least 2 doses of tolvaptan for the treatment of one occurrence of hyponatraemia secondary to SIADH.
24806|NCT02498652|O6|Outcome|Treatment R6|Allopurinol 300 mg qd + RDEA3170 20 mg qd
21131|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
21132|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
21133|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
21134|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
21135|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
21136|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
21137|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
21138|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
21139|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
21140|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
21158|NCT02545101|O1|Outcome|Tolvaptan|Adult patients who received at least 2 doses of tolvaptan for the treatment of one occurrence of hyponatraemia secondary to SIADH.
21668|NCT02539134|B4|Baseline|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
21141|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
21142|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
21143|NCT02545543|O1|Outcome|SCR Difference = Comparator QIV SCR % Minus Seqirus QIV SCR %|Seroconversion rate difference = Comparator QIV SCR percentage minus Seqirus QIV SCR percentage
21144|NCT02545543|O1|Outcome|GMT Ratios: GMT Comparator QIV Over GMT Seqirus QIV|GMT Ratios: GMT Comparator Quadrivalent Influenza Vaccine over GMT Seqirus Quadrivalent Influenza Vaccine
21145|NCT02545543|E2|Reported Event|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
21146|NCT02545543|E1|Reported Event|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
21147|NCT02545322|B1|Baseline|Adaptive Radiotherapy|"Follow-up CT scans during week 3 and week 5 of Treatment~Image-guided adaptive Radiotherapy arm:~Follow-up CT scans are performed on a conventional CT-simulator. Deformable Image Registration between the planning-CT and the follow-up CT (fCT) is done using a dedicated Software package. Delineations for target volumes and organs at risk are transferred to the fCT based on the Deformation vector fields calculated during deformable Image registration. Volumetric changes in target volumes and organs-at-risk are assessed. The initial treatment plan is transferred to the fCT scan. Dosimetric consequences of morphologic changes are analysed with the Focus on target dose coverage for the planning target volume. Adaption and plan re-optimisation are performed."
21148|NCT02545322|P1|Participant Flow|Adaptive Radiotherapy|"Follow-up CT scans during week 3 and week 5 of Treatment~Image-guided adaptive Radiotherapy arm:~Follow-up CT scans are performed on a conventional CT-simulator. Deformable Image Registration between the planning-CT and the follow-up CT (fCT) is done using a dedicated Software package. Delineations for target volumes and organs at risk are transferred to the fCT based on the Deformation vector fields calculated during deformable Image registration. Volumetric changes in target volumes and organs-at-risk are assessed. The initial treatment plan is transferred to the fCT scan. Dosimetric consequences of morphologic changes are analysed with the Focus on target dose coverage for the planning target volume. Adaption and plan re-optimisation are performed."
21149|NCT02545322|O1|Outcome|Adaptive Radiotherapy|"Follow-up CT scans during week 3 and week 5 of Treatment~Image-guided adaptive Radiotherapy arm:~Follow-up CT scans are performed on a conventional CT-simulator. Deformable Image Registration between the planning-CT and the follow-up CT (fCT) is done using a dedicated Software package. Delineations for target volumes and organs at risk are transferred to the fCT based on the Deformation vector fields calculated during deformable Image registration. Volumetric changes in target volumes and organs-at-risk are assessed. The initial treatment plan is transferred to the fCT scan. Dosimetric consequences of morphologic changes are analysed with the Focus on target dose coverage for the planning target volume. Adaption and plan re-optimisation are performed."
21150|NCT02545322|O1|Outcome|Adaptive Radiotherapy|"Follow-up CT scans during week 3 and week 5 of Treatment~Image-guided adaptive Radiotherapy arm:~Follow-up CT scans are performed on a conventional CT-simulator. Deformable Image Registration between the planning-CT and the follow-up CT (fCT) is done using a dedicated Software package. Delineations for target volumes and organs at risk are transferred to the fCT based on the Deformation vector fields calculated during deformable Image registration. Volumetric changes in target volumes and organs-at-risk are assessed. The initial treatment plan is transferred to the fCT scan. Dosimetric consequences of morphologic changes are analysed with the Focus on target dose coverage for the planning target volume. Adaption and plan re-optimisation are performed."
21151|NCT02545322|E1|Reported Event|Adaptive Radiotherapy|"Follow-up CT scans during week 3 and week 5 of Treatment~Image-guided adaptive Radiotherapy arm:~Follow-up CT scans are performed on a conventional CT-simulator. Deformable Image Registration between the planning-CT and the follow-up CT (fCT) is done using a dedicated Software package. Delineations for target volumes and organs at risk are transferred to the fCT based on the Deformation vector fields calculated during deformable Image registration. Volumetric changes in target volumes and organs-at-risk are assessed. The initial treatment plan is transferred to the fCT scan. Dosimetric consequences of morphologic changes are analysed with the Focus on target dose coverage for the planning target volume. Adaption and plan re-optimisation are performed."
21152|NCT02545101|B1|Baseline|Tolvaptan|Adult patients who received at least 2 doses of tolvaptan for the treatment of one occurrence of hyponatraemia secondary to SIADH.
36438|NCT02389088|O6|Outcome|Phase II - Week 0 - 24 Hours|
21159|NCT02545101|O1|Outcome|Tolvaptan|Adult patients who received at least 2 doses of tolvaptan for the treatment of one occurrence of hyponatraemia secondary to SIADH.
21160|NCT02545101|O1|Outcome|Tolvaptan|Adult patients who received at least 2 doses of tolvaptan for the treatment of one occurrence of hyponatraemia secondary to SIADH.
21161|NCT02545101|O1|Outcome|Tolvaptan|Adult patients who received at least 2 doses of tolvaptan for the treatment of one occurrence of hyponatraemia secondary to SIADH.
21162|NCT02545101|O1|Outcome|Tolvaptan|Adult patients who received at least 2 doses of tolvaptan for the treatment of one occurrence of hyponatraemia secondary to SIADH.
21163|NCT02545101|O1|Outcome|Tolvaptan|Adult patients who received at least 2 doses of tolvaptan for the treatment of one occurrence of hyponatraemia secondary to SIADH.
21164|NCT02545101|O1|Outcome|Tolvaptan|Adult patients who received at least 2 doses of tolvaptan for the treatment of one occurrence of hyponatraemia secondary to SIADH.
21165|NCT02545101|O1|Outcome|Tolvaptan|Adult patients who received at least 2 doses of tolvaptan for the treatment of one occurrence of hyponatraemia secondary to SIADH.
21166|NCT02545101|O1|Outcome|Tolvaptan|Adult patients who received at least 2 doses of tolvaptan for the treatment of one occurrence of hyponatraemia secondary to SIADH.
21167|NCT02545101|O1|Outcome|Tolvaptan|Adult patients who received at least 2 doses of tolvaptan for the treatment of one occurrence of hyponatraemia secondary to SIADH.
21168|NCT02545101|E1|Reported Event|Tolvaptan|Adult patients who received at least 2 doses of tolvaptan for the treatment of one occurrence of hyponatraemia secondary to SIADH.
21169|NCT02544074|B22|Baseline|Total|Total of all reporting groups
21170|NCT02544074|B21|Baseline|eSAGE Score of 22|"Participants who score a 22 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21171|NCT02544074|B20|Baseline|eSAGE Score of 21|"Participants who score a 21 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21172|NCT02544074|B19|Baseline|eSAGE Score of 20|"Participants who score a 20 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21173|NCT02544074|B18|Baseline|eSAGE Score of 19|"Participants who score a 19 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21174|NCT02544074|B17|Baseline|eSAGE Score of 18|"Participants who score a 18 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21175|NCT02544074|B16|Baseline|eSAGE Score of 17|"Participants who score a 17 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21176|NCT02544074|B15|Baseline|eSAGE Score of 16|"Participants who score a 16 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21177|NCT02544074|B14|Baseline|eSAGE Score of 15|"Participants who score a 15 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21178|NCT02544074|B13|Baseline|eSAGE Score of 14|"Participants who score a 14 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21179|NCT02544074|B12|Baseline|eSAGE Score of 13|"Participants who score a 13 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21180|NCT02544074|B11|Baseline|eSAGE Score of 12|"Participants who score a 12 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21181|NCT02544074|B10|Baseline|eSAGE Score of 11|"Participants who score an 11 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21182|NCT02544074|B9|Baseline|eSAGE Score of 10|"Participants who score a 10 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21183|NCT02544074|B8|Baseline|eSAGE Score of 9|"Participants who score a 9 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21184|NCT02544074|B7|Baseline|eSAGE Score of 8|"Participants who score an 8 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21185|NCT02544074|B6|Baseline|eSAGE Score of 7|"Participants who score a 7 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21186|NCT02544074|B5|Baseline|eSAGE Score of 6|"Participants who score a 6 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21187|NCT02544074|B4|Baseline|eSAGE Score of 5|"Participants who score a 5 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21188|NCT02544074|B3|Baseline|eSAGE Score of 4|"Participants who score a 4 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21189|NCT02544074|B2|Baseline|eSAGE Score of 3|"Participants who score a 3 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21190|NCT02544074|B1|Baseline|eSAGE Score of 2|"Participants who score a 2 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21669|NCT02539134|B3|Baseline|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
21191|NCT02544074|P21|Participant Flow|eSAGE Score of 22|"Participants who score a 22 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21192|NCT02544074|P20|Participant Flow|eSAGE Score of 21|"Participants who score a 21 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21193|NCT02544074|P19|Participant Flow|eSAGE Score of 20|"Participants who score a 20 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21194|NCT02544074|P18|Participant Flow|eSAGE Score of 19|"Participants who score a 19 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21195|NCT02544074|P17|Participant Flow|eSAGE Score of 18|"Participants who score a 18 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21196|NCT02544074|P16|Participant Flow|eSAGE Score of 17|"Participants who score a 17 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21197|NCT02544074|P15|Participant Flow|eSAGE Score of 16|"Participants who score a 16 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21198|NCT02544074|P14|Participant Flow|eSAGE Score of 15|"Participants who score a 15 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21199|NCT02544074|P13|Participant Flow|eSAGE Score of 14|"Participants who score a 14 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21200|NCT02544074|P12|Participant Flow|eSAGE Score of 13|"Participants who score a 13 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21201|NCT02544074|P11|Participant Flow|eSAGE Score of 12|"Participants who score a 12 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21202|NCT02544074|P10|Participant Flow|eSAGE Score of 11|"Participants who score an 11 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21203|NCT02544074|P9|Participant Flow|eSAGE Score of 10|"Participants who score a 10 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21204|NCT02544074|P8|Participant Flow|eSAGE Score of 9|"Participants who score a 9 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21205|NCT02544074|P7|Participant Flow|eSAGE Score of 8|"Participants who score an 8 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21206|NCT02544074|P6|Participant Flow|eSAGE Score of 7|"Participants who score a 7 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21207|NCT02544074|P5|Participant Flow|eSAGE Score of 6|"Participants who score a 6 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21208|NCT02544074|P4|Participant Flow|eSAGE Score of 5|"Participants who score a 5 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21209|NCT02544074|P3|Participant Flow|eSAGE Score of 4|"Participants who score a 4 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21210|NCT02544074|P2|Participant Flow|eSAGE Score of 3|"Participants who score a 3 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21211|NCT02544074|P1|Participant Flow|eSAGE Score of 2|"Participants who score a 2 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21212|NCT02544074|O1|Outcome|eSAGE Score Compared to the WAIS III Block Design Score|The investigators will compare the eSAGE scores to the WAIS III Block Design scores. Associations will be investigated using Spearman correlations.
21213|NCT02544074|O1|Outcome|eSAGE Score Compared to the WAIS III Letter-number Score|The investigators will compare the eSAGE scores to the WAIS III Letter-number scores. Associations will be investigated using Spearman correlations.
21214|NCT02544074|O1|Outcome|eSAGE Score Compared to the FAS Verbal Fluency Task Score|The investigators will compare the eSAGE scores to the FAS Verbal Fluency Task scores. Associations will be investigated using Spearman correlations.
21215|NCT02544074|O2|Outcome|eSAGE Score Compared to the HVLT Delayed Recall Score|The investigators will compare the eSAGE scores to the Hopkins Verbal Learning Test (HVLT) delayed recall scores. Associations will be investigated using Spearman correlations.
21216|NCT02544074|O1|Outcome|eSAGE Score Compared to the HVLT Total Learning Score|The investigators will compare the eSAGE scores to the Hopkins Verbal Learning Test (HVLT) total learning scores. Associations will be investigated using Spearman correlations.
21217|NCT02544074|O1|Outcome|eSAGE Score Compared to the WCST Score|The investigators will compare the eSAGE scores to the Wisconsin Card Sort Task (WCST) perseverative errors scores. Associations will be investigated using Spearman correlations.
21218|NCT02544074|O1|Outcome|eSAGE Score Compared to the Boston Naming Test Score|The investigators will compare the eSAGE scores to the Boston Naming Test scores. Associations will be investigated using Spearman correlations.
21247|NCT02543918|P2|Participant Flow|Boostrix® + Pneumovax®23|Boostrix® and Pneumovax®23 administered once by intramuscular (IM) injection into opposing arms at week 2.
21219|NCT02544074|O1|Outcome|eSAGE Score Compared to the MoCA Score|The investigators will compare the eSAGE scores with the Montreal Cognitive Assessment (MoCA) scores. Associations will be investigated using Spearman correlations.
21220|NCT02544074|O1|Outcome|eSAGE Score Compared to the Mini-Mental State Exam Score|The investigators will compare the eSAGE scores with the Mini-Mental State Examination (MMSE) scores. Associations will be investigated using Spearman correlations.
21221|NCT02544074|O1|Outcome|eSAGE Score Compared to the Paper SAGE Score|The investigators will compare the subject's scores on the SAGE in digital format to their paper SAGE scores to determine if these two formats are equivalent to each other. Associations will be investigated using Spearman correlations.
21222|NCT02544074|O1|Outcome|eSAGE Score Compared to the Sum of Neuropsychological Measures|"Analysis will consist of comparing the subject’s scores on the SAGE in digital format to their neuropsychological test scores. This will be a composite score of the neuropsychological testing scores. The neuropsychological measures include:~Boston Naming Test~Wisconsin Card Sort Task (WCST)~Hopkins Verbal Learning Test (HVLT)~FAS verbal fluency task~Wechsler Adult Intelligence Scale III (WAIS III) Letter-number and block design subtests~Associations will be investigated using Spearman correlations."
21223|NCT02544074|E21|Reported Event|eSAGE Score of 22|"Participants who score a 22 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21224|NCT02544074|E20|Reported Event|eSAGE Score of 21|"Participants who score a 21 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21225|NCT02544074|E19|Reported Event|eSAGE Score of 20|"Participants who score a 20 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21226|NCT02544074|E18|Reported Event|eSAGE Score of 19|"Participants who score a 19 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21227|NCT02544074|E17|Reported Event|eSAGE Score of 18|"Participants who score a 18 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21228|NCT02544074|E16|Reported Event|eSAGE Score of 17|"Participants who score a 17 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21229|NCT02544074|E15|Reported Event|eSAGE Score of 16|"Participants who score a 16 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21230|NCT02544074|E14|Reported Event|eSAGE Score of 15|"Participants who score a 15 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21231|NCT02544074|E13|Reported Event|eSAGE Score of 14|"Participants who score a 14 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21232|NCT02544074|E12|Reported Event|eSAGE Score of 13|"Participants who score a 13 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21233|NCT02544074|E11|Reported Event|eSAGE Score of 12|"Participants who score a 12 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21234|NCT02544074|E10|Reported Event|eSAGE Score of 11|"Participants who score an 11 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21235|NCT02544074|E9|Reported Event|eSAGE Score of 10|"Participants who score a 10 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21236|NCT02544074|E8|Reported Event|eSAGE Score of 9|"Participants who score a 9 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21237|NCT02544074|E7|Reported Event|eSAGE Score of 8|"Participants who score an 8 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21238|NCT02544074|E6|Reported Event|eSAGE Score of 7|"Participants who score a 7 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21239|NCT02544074|E5|Reported Event|eSAGE Score of 6|"Participants who score a 6 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21240|NCT02544074|E4|Reported Event|eSAGE Score of 5|"Participants who score a 5 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21241|NCT02544074|E3|Reported Event|eSAGE Score of 4|"Participants who score a 4 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21242|NCT02544074|E2|Reported Event|eSAGE Score of 3|"Participants who score a 3 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21243|NCT02544074|E1|Reported Event|eSAGE Score of 2|"Participants who score a 2 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
21244|NCT02543918|B3|Baseline|Total|Total of all reporting groups
21245|NCT02543918|B2|Baseline|Boostrix® + Pneumovax®23|Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
21246|NCT02543918|B1|Baseline|Ixekizumab + Boostrix® + Pneumovax®23|Ixekizumab administered once by SQ at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
24807|NCT02498652|O5|Outcome|Treatment R4|Allopurinol 300 mg qd + RDEA3170 10 mg qd
21248|NCT02543918|P1|Participant Flow|Ixekizumab + Boostrix® + Pneumovax®23|"Ixekizumab administered once by subcutaneous injection (SQ) at week 0 and once at week 2.~Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2."
21249|NCT02543918|O2|Outcome|Boostrix® + Pneumovax®23|Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
21250|NCT02543918|O1|Outcome|Ixekizumab + Boostrix® + Pneumovax®23|Ixekizumab administered once by SQ at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
21251|NCT02543918|E2|Reported Event|Boostrix® + Pneumovax®23|Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
21252|NCT02543918|E1|Reported Event|Ixekizumab + Boostrix® + Pneumovax®23|Ixekizumab administered once by SQ at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
21253|NCT02543528|B1|Baseline|Total Enrolled|All subjects that were enrolled into this study.
21254|NCT02543528|P5|Participant Flow|Etafilcon A (1-Day)|All subjects wore the etafilcon A 1-Day contact lens during the 2-week adaptation period.
21255|NCT02543528|P4|Participant Flow|Etafilcon A (Resuable)|Subjects that were randomized to received the etafilcon A (Reusable) lens throughout the entire duration of the extended wear period.
21256|NCT02543528|P3|Participant Flow|Investigational Lens 3|Subjects that were randomized to receive the investigational contact lens 3 throughout the entire duration of the extended wear period.
21257|NCT02543528|P2|Participant Flow|Investigational Lens 2|Subjects that were randomized to receive the investigational contact lens 2 throughout the entire duration of the extended wear period.
21258|NCT02543528|P1|Participant Flow|Investigational Lens 1|Subjects that were randomized to receive the investigational contact lens 1 throughout the entire duration of the extended wear period.
21259|NCT02543528|O4|Outcome|Etafilcon A (Resuable)|Subjects that were randomized to received the etafilcon A (Reusable) lens throughout the entire duration of the extended wear period.
21260|NCT02543528|O3|Outcome|Investigational Lens 2|Subjects that were randomized to receive the investigational contact lens 2 throughout the entire duration of the extended wear period.
21261|NCT02543528|O2|Outcome|Investigational Lens 1|Subjects that were randomized to receive the investigational contact lens 1 throughout the entire duration of the extended wear period.
21262|NCT02543528|O1|Outcome|Investigational Lens 3|Subjects that were randomized to receive the investigational contact lens 3 throughout the entire duration of the extended wear period.
21263|NCT02543528|O4|Outcome|Etafilcon A (Resuable)|Subjects that were randomized to received the etafilcon A (Reusable) lens throughout the entire duration of the extended wear period.
21264|NCT02543528|O3|Outcome|Investigational Lens 2|Subjects that were randomized to receive the investigational contact lens 2 throughout the entire duration of the extended wear period.
21265|NCT02543528|O2|Outcome|Investigational Lens 1|Subjects that were randomized to receive the investigational contact lens 1 throughout the entire duration of the extended wear period.
21266|NCT02543528|O1|Outcome|Investigational Lens 3|Subjects that were randomized to receive the investigational contact lens 1 throughout the entire duration of the extended wear period.
21267|NCT02543528|O4|Outcome|Etafilcon A (Resuable)|Subjects that were randomized to received the etafilcon A (Reusable) lens throughout the entire duration of the extended wear period.
21268|NCT02543528|O3|Outcome|Investigational Lens 2|Subjects that were randomized to receive the investigational contact lens 2 throughout the entire duration of the extended wear period.
21269|NCT02543528|O2|Outcome|Investigational Lens 3|Subjects that were randomized to receive the investigational contact lens 3 throughout the entire duration of the extended wear period.
21270|NCT02543528|O1|Outcome|Investigational Lens 1|Subjects that were randomized to receive the investigational contact lens 1 throughout the entire duration of the extended wear period.
21271|NCT02543528|E5|Reported Event|Investigational Lens 2|Subjects that were randomized to receive the investigational contact lens 2 throughout the entire duration of the extended wear period.
21272|NCT02543528|E4|Reported Event|Etafilcon A (Resuable)|Subjects that were randomized to received the etafilcon A (Reusable) lens throughout the entire duration of the extended wear period.
21273|NCT02543528|E3|Reported Event|Investigational Lens 1|Subjects that were randomized to receive the investigational contact lens 1 throughout the entire duration of the extended wear period.
21274|NCT02543528|E2|Reported Event|Investigational Lens 3|Subjects that were randomized to receive the investigational contact lens 3 throughout the entire duration of the extended wear period.
21275|NCT02543528|E1|Reported Event|Etafilcon A (1-Day)|All subject wore the etafilcon A (1-Day) contact lens throughout the entire duration of the adaptation period (14-Days).
21276|NCT02543437|B1|Baseline|X3 Liner|"X3 28mm, 32mm and 36mm liner~Trident Acetabular X3 Insert"
21277|NCT02543437|P1|Participant Flow|Trident Acetabular X3 Insert|Trident Acetabular X3 Insert 28mm, 32mm and 36mm liner
21278|NCT02543437|O1|Outcome|X3 Liner|"X3 28mm, 32mm and 36mm liner~Trident Acetabular X3 Insert"
21279|NCT02543437|O1|Outcome|X3 Liner|"X3 28mm, 32mm and 36mm liner~Trident Acetabular X3 Insert"
21280|NCT02543437|E1|Reported Event|X3 Liner|"X3 28mm, 32mm and 36mm liner~Trident Acetabular X3 Insert"
21281|NCT02543398|B3|Baseline|Total|Total of all reporting groups
21282|NCT02543398|B2|Baseline|No Ridge Preservation|"The molar extraction socket is left to heal by itself without any grafting material or membrane, i.e. “Spontaneous Healing” (No ridge preservation is performed)~Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site."
21302|NCT02542943|O1|Outcome|Experimental Oral Rinse1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
21303|NCT02542943|O3|Outcome|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
21336|NCT02542761|E1|Reported Event|Carbon Fiber Prosthetic Foot (CFPF)|All types of currently commercially available carbon fiber energy storage and return prosthetic feet will be considered appropriate.
21283|NCT02543398|B1|Baseline|Ridge Preservation|"The molar extraction socket is grafted with FDA approved materials, which includes a bone graft material derived from human donors (enCore®, Osteogenics biomedical, Lubbock, TX) and a membrane (like a thin sheet of paper) covering the grafted extraction socket. The membrane used will need to be removed at a later point since it is non-resorbable (it will not “dissolve” by itself). This membrane is made of dense polytetrafluoroethylene (dPTFE) (Cytoplast™, Osteogenics biomedical, Lubbock, TX). The procedure is called “Ridge preservation”~Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site."
21284|NCT02543398|P2|Participant Flow|No Ridge Preservation|"The molar extraction socket is left to heal by itself without any grafting material or membrane, i.e. “Spontaneous Healing” (No ridge preservation is performed)~Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site."
21285|NCT02543398|P1|Participant Flow|Ridge Preservation|"The molar extraction socket is grafted with FDA approved materials, which includes a bone graft material derived from human donors (enCore®, Osteogenics biomedical, Lubbock, TX) and a membrane (like a thin sheet of paper) covering the grafted extraction socket. The membrane used will need to be removed at a later point since it is non-resorbable (it will not “dissolve” by itself). This membrane is made of dense polytetrafluoroethylene (dPTFE) (Cytoplast™, Osteogenics biomedical, Lubbock, TX). The procedure is called “Ridge preservation”~Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site."
21286|NCT02543398|O2|Outcome|No Ridge Preservation|"The molar extraction socket is left to heal by itself without any grafting material or membrane, i.e. “Spontaneous Healing” (No ridge preservation is performed)~Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site."
21287|NCT02543398|O1|Outcome|Ridge Preservation|"The molar extraction socket is grafted with FDA approved materials, which includes a bone graft material derived from human donors (enCore®, Osteogenics biomedical, Lubbock, TX) and a membrane (like a thin sheet of paper) covering the grafted extraction socket. The membrane used will need to be removed at a later point since it is non-resorbable (it will not “dissolve” by itself). This membrane is made of dense polytetrafluoroethylene (dPTFE) (Cytoplast™, Osteogenics biomedical, Lubbock, TX). The procedure is called “Ridge preservation”~Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site."
21288|NCT02543398|E2|Reported Event|No Ridge Preservation|"The molar extraction socket is left to heal by itself without any grafting material or membrane, i.e. “Spontaneous Healing” (No ridge preservation is performed)~Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site."
21289|NCT02543398|E1|Reported Event|Ridge Preservation|"The molar extraction socket is grafted with FDA approved materials, which includes a bone graft material derived from human donors (enCore®, Osteogenics biomedical, Lubbock, TX) and a membrane (like a thin sheet of paper) covering the grafted extraction socket. The membrane used will need to be removed at a later point since it is non-resorbable (it will not “dissolve” by itself). This membrane is made of dense polytetrafluoroethylene (dPTFE) (Cytoplast™, Osteogenics biomedical, Lubbock, TX). The procedure is called “Ridge preservation”~Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site."
21290|NCT02542943|B4|Baseline|Total|Total of all reporting groups
21291|NCT02542943|B3|Baseline|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
21292|NCT02542943|B2|Baseline|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
21293|NCT02542943|B1|Baseline|Experimental Oral Rinse1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
21294|NCT02542943|P3|Participant Flow|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
21295|NCT02542943|P2|Participant Flow|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
21296|NCT02542943|P1|Participant Flow|Experimental Oral Rinse 1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% weight by weight (w/w) dipotasium oxalate monohydrate [KOX], pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
21297|NCT02542943|O3|Outcome|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
21298|NCT02542943|O2|Outcome|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
21299|NCT02542943|O1|Outcome|Experimental Oral Rinse1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
21300|NCT02542943|O3|Outcome|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
21301|NCT02542943|O2|Outcome|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
21334|NCT02542761|O1|Outcome|Carbon Fiber Prosthetic Foot (CFPF)|All types of currently commercially available carbon fiber energy storage and return prosthetic feet will be considered appropriate.
21304|NCT02542943|O2|Outcome|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
21305|NCT02542943|O1|Outcome|Experimental Oral Rinse1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
21306|NCT02542943|O3|Outcome|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
21307|NCT02542943|O2|Outcome|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
21308|NCT02542943|O1|Outcome|Experimental Oral Rinse1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
21309|NCT02542943|O3|Outcome|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
21310|NCT02542943|O2|Outcome|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
21311|NCT02542943|O1|Outcome|Experimental Oral Rinse 1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
21312|NCT02542943|O2|Outcome|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
21313|NCT02542943|O1|Outcome|Experimental Oral Rinse1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
21314|NCT02542943|O3|Outcome|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
21315|NCT02542943|O2|Outcome|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
21316|NCT02542943|O1|Outcome|Experimental Oral Rinse1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
21317|NCT02542943|E3|Reported Event|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
21318|NCT02542943|E2|Reported Event|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
21319|NCT02542943|E1|Reported Event|Experimental Oral Rinse 1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
21320|NCT02542761|B1|Baseline|Entire Study Population|Includes groups studying CFPF first and FPF first.
21321|NCT02542761|P2|Participant Flow|FPF First, Then CFPF|"After a 4 week acclimation period, subjects were studied on the study provided fiberglass composite foot (FPF), followed by another 4 week acclimation period, then studied on their current carbon fiber composite foot (CFPF).~Fiberglass Composite foot: The Rush foot is a fiberglass composite energy storage and return prosthetic foot.~Carbon Fiber Composite Foot: All types of currently commercially available carbon fiber energy storage and return prosthetic feet will be considered appropriate."
21322|NCT02542761|P1|Participant Flow|CFPF First, Then FPF|"After a 4 week acclimation period, subjects were studied on their current carbon fiber composite foot (CFPF), followed by another 4 week acclimation period, then studied on the study provided fiberglass composite foot (FPF).~Fiberglass Composite foot: The Rush foot is a fiberglass composite energy storage and return prosthetic foot.~Carbon Fiber Composite Foot: All types of currently commercially available carbon fiber energy storage and return prosthetic feet will be considered appropriate."
21323|NCT02542761|O2|Outcome|Fiberglass Prosthetic Foot (FPF)|The Rush87 foot is a fiberglass composite energy storage and return prosthetic foot.
21324|NCT02542761|O1|Outcome|Carbon Fiber Prosthetic Foot (CFPF)|All types of currently commercially available carbon fiber energy storage and return prosthetic feet will be considered appropriate.
21325|NCT02542761|O2|Outcome|Fiberglass Prosthetic Foot (FPF)|The Rush87 foot is a fiberglass composite energy storage and return prosthetic foot.
21326|NCT02542761|O1|Outcome|Carbon Fiber Prosthetic Foot (CFPF)|All types of currently commercially available carbon fiber energy storage and return prosthetic feet will be considered appropriate.
21327|NCT02542761|O2|Outcome|Fiberglass Prosthetic Foot (FPF)|The Rush87 foot is a fiberglass composite energy storage and return prosthetic foot.
21328|NCT02542761|O1|Outcome|Carbon Fiber Prosthetic Foot (CFPF)|All types of currently commercially available carbon fiber energy storage and return prosthetic feet will be considered appropriate.
21329|NCT02542761|O2|Outcome|Fiberglass Prosthetic Foot (FPF)|The Rush87 foot is a fiberglass composite energy storage and return prosthetic foot.
21330|NCT02542761|O1|Outcome|Carbon Fiber Prosthetic Foot (CFPF)|All types of currently commercially available carbon fiber energy storage and return prosthetic feet will be considered appropriate.
21331|NCT02542761|O2|Outcome|Fiberglass Prosthetic Foot (FPF)|The Rush87 foot is a fiberglass composite energy storage and return prosthetic foot.
21332|NCT02542761|O1|Outcome|Carbon Fiber Prosthetic Foot (CFPF)|All types of currently commercially available carbon fiber energy storage and return prosthetic feet will be considered appropriate.
21333|NCT02542761|O2|Outcome|Fiberglass Prosthetic Foot (FPF)|The Rush87 foot is a fiberglass composite energy storage and return prosthetic foot.
21337|NCT02542280|B3|Baseline|Total|Total of all reporting groups
21338|NCT02542280|B2|Baseline|no Endometrial Injury|"Ovarian stimulation combined with intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
21339|NCT02542280|B1|Baseline|Endometrial Injury|"Endometrial injury during ovarian stimulation combined with intrauterine insemination.~endometrial injury.: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
21340|NCT02542280|P2|Participant Flow|no Endometrial Injury|"Ovarian stimulation combined with intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by clomiphene citrate 100mg orally (from cycle day 2 for 5 days) and human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
21341|NCT02542280|P1|Participant Flow|Endometrial Injury|"Endometrial injury during ovarian stimulation cycle combined with intrauterine insemination.~endometrial injury: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by clomiphene citrate 100mg orally (from cycle day 2 for 5 days) and human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
21342|NCT02542280|O2|Outcome|no Endometrial Injury|"Ovarian stimulation combined with intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
21343|NCT02542280|O1|Outcome|Endometrial Injury|"Endometrial injury during ovarian stimulation combined with intrauterine insemination.~endometrial injury.: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
21344|NCT02542280|O2|Outcome|no Endometrial Injury|"Ovarian stimulation combined with intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
21345|NCT02542280|O1|Outcome|Endometrial Injury|"Endometrial injury during ovarian stimulation combined with intrauterine insemination.~endometrial injury.: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
21346|NCT02542280|E2|Reported Event|no Endometrial Injury|"Ovarian stimulation combined with intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
21347|NCT02542280|E1|Reported Event|Endometrial Injury|"Endometrial injury during ovarian stimulation combined with intrauterine insemination.~endometrial injury.: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
21348|NCT02542072|B3|Baseline|Total|Total of all reporting groups
21349|NCT02542072|B2|Baseline|Samfilcon A, Then Comfilcon A|"Randomized participants who wore the samfilcon A lens pair for one month, then comfilcon A lens pair during the cross over study.~comfilcon A: contact lenses~samfilcon A: contact lenses"
21350|NCT02542072|B1|Baseline|Comfilcon A, Then Samfilcon A|"Randomized participants who wore the comfilcon A lens pair for one month, then samfilcon A lens pair during the cross over study.~comfilcon A: contact lenses~samfilcon A: contact lenses"
21351|NCT02542072|P2|Participant Flow|Samfilcon A, Then Comfilcon A|"Participants were randomized to wear the samfilcon A lens pair for one month then cross over to the comfilcon A lens pair.~samfilcon A: contact lens~comfilcon A: contact lens"
21352|NCT02542072|P1|Participant Flow|Comfilcon A, Then Samfilcon A|"Participants were randomized to wear the comfilcon A lens pair for one month, then cross over to the samfilcon A lens pair.~comfilcon A: contact lens~samfilcon A: contact lens"
21353|NCT02542072|O5|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21354|NCT02542072|O4|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21355|NCT02542072|O3|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21356|NCT02542072|O2|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21357|NCT02542072|O1|Outcome|Habitual Lens (Baseline)|Habitual data were collected of participants before lens dispensed.
21358|NCT02542072|O6|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21359|NCT02542072|O5|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21360|NCT02542072|O4|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21361|NCT02542072|O3|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21362|NCT02542072|O2|Outcome|Samfilcon A (Baseline)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21363|NCT02542072|O1|Outcome|Comfilcon A (Baseline)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21364|NCT02542072|O6|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21365|NCT02542072|O5|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21366|NCT02542072|O4|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21367|NCT02542072|O3|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21368|NCT02542072|O2|Outcome|Samfilcon A (Baseline)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21369|NCT02542072|O1|Outcome|Comfilcon A (Baseline)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21370|NCT02542072|O6|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21371|NCT02542072|O5|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21372|NCT02542072|O4|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21373|NCT02542072|O3|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21374|NCT02542072|O2|Outcome|Samfilcon A (Baseline)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21375|NCT02542072|O1|Outcome|Comfilcon A (Baseline)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21376|NCT02542072|O6|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21377|NCT02542072|O5|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21378|NCT02542072|O4|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21379|NCT02542072|O3|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21380|NCT02542072|O2|Outcome|Samfilcon A (Baseline)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21381|NCT02542072|O1|Outcome|Comfilcon A (Baseline)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21382|NCT02542072|O6|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21383|NCT02542072|O5|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21384|NCT02542072|O4|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21385|NCT02542072|O3|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21386|NCT02542072|O2|Outcome|Samfilcon A (Baseline)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21387|NCT02542072|O1|Outcome|Comfilcon A (Baseline)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21388|NCT02542072|O6|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21389|NCT02542072|O5|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21390|NCT02542072|O4|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21391|NCT02542072|O3|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21392|NCT02542072|O2|Outcome|Samfilcon A (Baseline)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21393|NCT02542072|O1|Outcome|Comfilcon A (Baseline)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21394|NCT02542072|O5|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21395|NCT02542072|O4|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21396|NCT02542072|O3|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21397|NCT02542072|O2|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21398|NCT02542072|O1|Outcome|Habitual Lens (Baseline)|Habitual data were collected of participants before lens dispensed.
21399|NCT02542072|O4|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21400|NCT02542072|O3|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21401|NCT02542072|O2|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21402|NCT02542072|O1|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21403|NCT02542072|O4|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21404|NCT02542072|O3|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21405|NCT02542072|O2|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21406|NCT02542072|O1|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21407|NCT02542072|O6|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21408|NCT02542072|O5|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21409|NCT02542072|O4|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21410|NCT02542072|O3|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21411|NCT02542072|O2|Outcome|Samfilcon A (Baseline)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21412|NCT02542072|O1|Outcome|Comfilcon A (Baseline)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21413|NCT02542072|O5|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21414|NCT02542072|O4|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21415|NCT02542072|O3|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21416|NCT02542072|O2|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21417|NCT02542072|O1|Outcome|Habitual Lenses (Baseline)|Habitual data were collected of participants before lens dispensed.
21418|NCT02542072|O5|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21419|NCT02542072|O4|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21420|NCT02542072|O3|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21421|NCT02542072|O2|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21422|NCT02542072|O1|Outcome|Habitual Lens (Baseline)|Habitual data were collected of participants before lens dispensed.
21423|NCT02542072|O5|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21424|NCT02542072|O4|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21425|NCT02542072|O3|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21426|NCT02542072|O2|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21427|NCT02542072|O1|Outcome|Habitual Lens (Baseline)|Habitual data were collected of participants before lens dispensed.
21428|NCT02542072|O5|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21429|NCT02542072|O4|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21430|NCT02542072|O3|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21431|NCT02542072|O2|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21432|NCT02542072|O1|Outcome|Habitual Lens (Baseline)|Habitual data were collected of participants before lens dispensed.
21433|NCT02542072|O5|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21434|NCT02542072|O4|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
24808|NCT02498652|O4|Outcome|Treatment R2|Allopurinol 300 mg qd + RDEA3170 5 mg qd
21435|NCT02542072|O3|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21436|NCT02542072|O2|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21437|NCT02542072|O1|Outcome|Habitual Lens (Baseline)|Habitual data were collected of participants before lens dispensed.
21438|NCT02542072|O6|Outcome|Samfilcon A (Day 26)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21439|NCT02542072|O5|Outcome|Comfilcon A (Day 26)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21440|NCT02542072|O4|Outcome|Samfilcon A (Day 12)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21441|NCT02542072|O3|Outcome|Comfilcon A (Day 12)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21442|NCT02542072|O2|Outcome|Samfilcon A (Day 3)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21443|NCT02542072|O1|Outcome|Comfilcon A (Day 3)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21444|NCT02542072|O5|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21445|NCT02542072|O4|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21446|NCT02542072|O3|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21447|NCT02542072|O2|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21448|NCT02542072|O1|Outcome|Habitual Lens (Baseline)|Habitual data were collected of participants before lens dispensed.
21449|NCT02542072|E2|Reported Event|Samfilcon A|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
21450|NCT02542072|E1|Reported Event|Comfilcon A|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
21451|NCT02541864|B3|Baseline|Total|Total of all reporting groups
21452|NCT02541864|B2|Baseline|Hybrid Therapy|"a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days~Hybrid therapy: a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days"
21453|NCT02541864|B1|Baseline|Pantoprazole+Bismuth+Tetra+Metro|"pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, metronidazole 250 mg qid for 14 days~pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days"
21454|NCT02541864|P2|Participant Flow|Hybrid Therapy|"a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days~Hybrid therapy: a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days"
21455|NCT02541864|P1|Participant Flow|Pantoprazole+Bismuth+Tetra+Metro|"pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, metronidazole 250 mg qid for 14 days~pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days"
21456|NCT02541864|O2|Outcome|Hybrid Therapy|"a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days~Hybrid therapy: a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days"
21457|NCT02541864|O1|Outcome|Pantoprazole+Bismuth+Tetra+Metro|"pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, metronidazole 250 mg qid for 14 days~pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days"
21458|NCT02541864|E2|Reported Event|Hybrid Therapy|"a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days~Hybrid therapy: a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days"
21459|NCT02541864|E1|Reported Event|Pantoprazole+Bismuth+Tetra+Metro|"pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, metronidazole 250 mg qid for 14 days~pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days"
21460|NCT02541422|B1|Baseline|All Study Participants|All study participants received the 2 interventions - NAC and placebo. The participants completed one intervention on one day and returned to complete the other intervention on a subsequent day.
21461|NCT02541422|P2|Participant Flow|Placebo First Then NAC Group|Patients receiving placebo after drinking to breathalyzer value 0.1 and then completed the survey in the morning after drinking and then at a later date returned and drank again to BrAC level of 0.1 and received NAC then again completed the survey in the morning
21510|NCT02540772|O1|Outcome|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
21462|NCT02541422|P1|Participant Flow|NAC First, Then Placebo|Patients receiving NAC after drinking to breathalyzer value 0.1 and then completed the survey in the morning after drinking and then at a later date returned and drank again to BrAC level of 0.1 and received placebo then again completed the survey in the morning
21463|NCT02541422|O2|Outcome|Placebo Group|"Patients receiving placebo after drinking to breathalyzer value 0.1~placebo"
21464|NCT02541422|O1|Outcome|NAC Group|"Patients receiving NAC after drinking to breathalyzer value 0.1~N Acetyl Cysteine"
21465|NCT02541422|E2|Reported Event|Placebo Group|"Patients receiving placebo after drinking to breathalyzer value 0.1~placebo"
21466|NCT02541422|E1|Reported Event|NAC Group|"Patients receiving NAC after drinking to breathalyzer value 0.1~N Acetyl Cysteine"
21467|NCT02540850|B4|Baseline|Total|Total of all reporting groups
21468|NCT02540850|B3|Baseline|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
21469|NCT02540850|B2|Baseline|Precancerous Disease Group|subjects with adenoma or polyps
21470|NCT02540850|B1|Baseline|CRC Group|stage 0-IV CRC subjects
21471|NCT02540850|P3|Participant Flow|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
21472|NCT02540850|P2|Participant Flow|Precancerous Disease Group|subjects with adenoma or polyps
21473|NCT02540850|P1|Participant Flow|CRC Group|stage 0-IV CRC subjects
21474|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
21475|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
21476|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
21477|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
21478|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
21479|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
21480|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
21481|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
21482|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
21483|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
21484|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
21485|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
21486|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
21487|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
21488|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
21489|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
21490|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
21491|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
21492|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
21493|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
21494|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
21495|NCT02540850|E3|Reported Event|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
21496|NCT02540850|E2|Reported Event|Precancerous Disease Group|subjects with adenoma or polyps
21497|NCT02540850|E1|Reported Event|CRC Group|stage 0-IV CRC subjects
21498|NCT02540772|B3|Baseline|Total|Total of all reporting groups
21499|NCT02540772|B2|Baseline|No Treatment|Patients in the control group only performed the baselines.
21500|NCT02540772|B1|Baseline|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
21501|NCT02540772|P2|Participant Flow|No Treatment|Patients in the control group only performed the baselines.
21502|NCT02540772|P1|Participant Flow|Neuropsychological Treatment|"The tested treatment is a combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.~Neuropsychological treatment: Participants had to learn some brief material (words, faces, pictures, news), after which they were asked for an immediate and a delayed recall. After both recalls, participants were confronted with feedback about correct responses, non-responses and errors. This type of feedback worked on: 1) selective attention during the learning phase, training patients to focus on the relevant details of the stimuli; 2) monitoring processes during the retrieval phase, reinforcing the strategic search and training patients to inhibit traces that were irrelevant; and 3) memory control processes after the retrieval phase. The treatment consisted of 9 sessions and lasted for 3 weeks and the participants performed a baseline before and after treatment."
21503|NCT02540772|O2|Outcome|No Treatment|Patients in the control group only performed the baselines.
21504|NCT02540772|O1|Outcome|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
21505|NCT02540772|O2|Outcome|No Treatment|Patients in the control group only performed the baselines.
21506|NCT02540772|O1|Outcome|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
21507|NCT02540772|O2|Outcome|No Treatment|Patients in the control group only performed the baselines.
21508|NCT02540772|O1|Outcome|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
21509|NCT02540772|O2|Outcome|No Treatment|Patients in the control group only performed the baselines.
24809|NCT02498652|O3|Outcome|Treatment A2b|Allopurinol 600 mg (300 mg bid)
21512|NCT02540772|E1|Reported Event|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
21513|NCT02540447|B3|Baseline|Total|Total of all reporting groups
21514|NCT02540447|B2|Baseline|No Purge|The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
21515|NCT02540447|B1|Baseline|Purge|"The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
21516|NCT02540447|P2|Participant Flow|No Purge|The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
21517|NCT02540447|P1|Participant Flow|Purge|"The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
21518|NCT02540447|O2|Outcome|No Purge|Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
21519|NCT02540447|O1|Outcome|Purge|"Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
21520|NCT02540447|O2|Outcome|No Purge|Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
21521|NCT02540447|O1|Outcome|Purge|"Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
21522|NCT02540447|O2|Outcome|No Purge|Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
21523|NCT02540447|O1|Outcome|Purge|"Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
21524|NCT02540447|O2|Outcome|No Purge|Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
21525|NCT02540447|O1|Outcome|Purge|"Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
21526|NCT02540447|O2|Outcome|No Purge|Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
21558|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
24810|NCT02498652|O2|Outcome|Treatment A2q|Allopurinol 600 mg qd
21527|NCT02540447|O1|Outcome|Purge|"Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
21528|NCT02540447|E2|Reported Event|No Purge|The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
21529|NCT02540447|E1|Reported Event|Purge|"The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
21530|NCT02540434|B3|Baseline|Total|Total of all reporting groups
21531|NCT02540434|B2|Baseline|Cryopreciptiate Arm|"Subjects will be infused with cryoprecipitate if ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.~ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of curve.~Cryoprecipitate: Subjects with hypofibrinogenemia who are randomized to the Cryoprecipitate arm will be transfused with Cryoprecipitate"
21532|NCT02540434|B1|Baseline|RiaSTAP Arm|"Subjects will be infused with RiaSTAP if the ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.~ROTEM: ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve.~RiaSTAP: Subjects with hypofibrinogenemia who are randomized to the RiaSTAP arm will be transfused with concentrated fibrinogen"
21533|NCT02540434|P2|Participant Flow|Cryopreciptiate Arm|"Subjects will be infused with cryoprecipitate if ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.~ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of curve.~Cryoprecipitate: Subjects with hypofibrinogenemia who are randomized to the Cryoprecipitate arm will be transfused with Cryoprecipitate"
21534|NCT02540434|P1|Participant Flow|RiaSTAP Arm|"Subjects will be infused with RiaSTAP if the ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.~ROTEM: ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve.~RiaSTAP: Subjects with hypofibrinogenemia who are randomized to the RiaSTAP arm will be transfused with concentrated fibrinogen"
21535|NCT02540434|O2|Outcome|Cryopreciptiate Arm|"Subjects will be infused with cryoprecipitate if the ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present. ROTEM delta will be used to identify intraoperative coagulation abnormalities.~Cryoprecipitate: Subjects with hypofibrinogenemia who are randomized to the Cryoprecipitate arm will be transfused with Cry"
21536|NCT02540434|O1|Outcome|RiaSTAP Arm|"Subjects will be infused with RiaSTAP if the ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.~ROTEM: ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve.~RiaSTAP: Subjects with hypofibrinogenemia who are randomized to the RiaSTAP arm will be transfused with concentrated fibrinogen"
21537|NCT02540434|O2|Outcome|Cryopreciptiate Arm|"Subjects will be infused with cryoprecipitate if the ROTEM FIBTEM A10 value less than or equal to 10 mm and microvascular bleeding is present.~ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve.~Cryoprecipitate: Subjects with hypofibrinogenemia who are randomized to the Cryoprecipitate arm will be transfused with Cryoprecipitate"
21538|NCT02540434|O1|Outcome|RiaSTAP Arm|"Subjects will be infused with RiaSTAP if the ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.~ROTEM: ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve.~RiaSTAP: Subjects with hypofibrinogenemia who are randomized to the RiaSTAP arm will be transfused with concentrated fibrinogen"
21539|NCT02540434|E2|Reported Event|RiaSTAP Arm|"Subjects will be infused with RiaSTAP if the ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.RiaSTAP: Subjects with hypofibrinogenemia who are randomized to the RiaSTAP arm will be transfused with concentrated fibrinogen.~Only enrolled patients randomized to RiaSTAP are at risk for riastap-related adverse events. 0 subjects out of total 22 consented were randomized to this arm, so no subjects were at risk to adverse events from this arm."
21540|NCT02540434|E1|Reported Event|Cryopreciptiate Arm|"Subjects will be infused with cryoprecipitate if ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present. ROTEM delta will be used to identify intraoperative coagulation abnormalities. Cryoprecipitate: Subjects with hypofibrinogenemia who are randomized to the Cryoprecipitate arm will be transfused with Cryoprecipitate.~Only enrolled patients randomized to cryoprecipitate arm are at risk for cryoprecipitate-related adverse events. 1 subject out of total 22 consented were randomized to this arm, so 1 subject was at risk to adverse events from this arm. No events were reported."
21541|NCT02540356|B3|Baseline|Total|Total of all reporting groups
21542|NCT02540356|B2|Baseline|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
21543|NCT02540356|B1|Baseline|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
21544|NCT02540356|P2|Participant Flow|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
21545|NCT02540356|P1|Participant Flow|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
21546|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
21547|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
21548|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
21549|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
21550|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
21551|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
21552|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
21553|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
21554|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
21555|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
21556|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
21557|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
21559|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
21560|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
21561|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
21562|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
21563|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
21564|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
21565|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
21566|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
21567|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
21568|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
21569|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
21570|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
21571|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
21572|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
21573|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
21574|NCT02540356|E1|Reported Event|Overall Trial|Treatment with Imalumab (BAX69) over a 4-week treatment period administered weekly at one of the following dose regimens: BAX69 5mg/kg IP (intraperitoneal) (Cohort S1), 10mg/kg IP (Cohort S2), 15mg/kg IP (Cohort S3), 5mg/kg IV (intravenous) + 5mg/kg IP (intraperitoneal) (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
21575|NCT02540265|B4|Baseline|Total|Total of all reporting groups
21576|NCT02540265|B3|Baseline|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
21577|NCT02540265|B2|Baseline|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.~N1539"
21578|NCT02540265|B1|Baseline|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.~N1539"
21579|NCT02540265|P3|Participant Flow|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
21580|NCT02540265|P2|Participant Flow|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.~N1539"
21581|NCT02540265|P1|Participant Flow|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.~N1539"
21582|NCT02540265|O3|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
21583|NCT02540265|O2|Outcome|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.~N1539"
21584|NCT02540265|O1|Outcome|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.~N1539"
21585|NCT02540265|O3|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
21586|NCT02540265|O2|Outcome|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.~N1539"
21587|NCT02540265|O1|Outcome|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.~N1539"
21588|NCT02540265|O3|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
21589|NCT02540265|O2|Outcome|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.~N1539"
21590|NCT02540265|O1|Outcome|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.~N1539"
21591|NCT02540265|O3|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
21592|NCT02540265|O2|Outcome|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.~N1539"
21593|NCT02540265|O1|Outcome|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.~N1539"
21594|NCT02540265|O3|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
21595|NCT02540265|O2|Outcome|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.~N1539"
21596|NCT02540265|O1|Outcome|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.~N1539"
21597|NCT02540265|E3|Reported Event|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
21598|NCT02540265|E2|Reported Event|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.~N1539"
24811|NCT02498652|O1|Outcome|Treatment A1|Allopurinol 300 mg qd
21600|NCT02540213|B1|Baseline|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
21601|NCT02540213|P1|Participant Flow|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 micrograms per kilogram (mcg/kg) body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 grams per deciliter (g/dL), the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight)..
21602|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
21603|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
21604|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
21605|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
21606|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
21607|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
21608|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
21609|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
21610|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
21611|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
21612|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
21613|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
21614|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
21670|NCT02539134|B2|Baseline|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
21720|NCT02539134|O2|Outcome|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
21615|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
21616|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
21617|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
21618|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
21619|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
21620|NCT02540213|E1|Reported Event|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
21621|NCT02539992|B4|Baseline|Total|Total of all reporting groups
21622|NCT02539992|B3|Baseline|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
21623|NCT02539992|B2|Baseline|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
21624|NCT02539992|B1|Baseline|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
21625|NCT02539992|P3|Participant Flow|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
21626|NCT02539992|P2|Participant Flow|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
21627|NCT02539992|P1|Participant Flow|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
21628|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
21629|NCT02539992|O2|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
21630|NCT02539992|O1|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
21631|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
21632|NCT02539992|O2|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
21633|NCT02539992|O1|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
21634|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
36439|NCT02389088|O5|Outcome|Phase I - Week 6 - 24 Hour|
21635|NCT02539992|O2|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
21636|NCT02539992|O1|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
21637|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
21638|NCT02539992|O2|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
21639|NCT02539992|O1|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
21640|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
21641|NCT02539992|O2|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
21642|NCT02539992|O1|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
21643|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
21644|NCT02539992|O2|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
21645|NCT02539992|O1|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
21646|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
21647|NCT02539992|O2|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
21648|NCT02539992|O1|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
21649|NCT02539992|E3|Reported Event|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
21650|NCT02539992|E2|Reported Event|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
21651|NCT02539992|E1|Reported Event|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
21652|NCT02539797|B1|Baseline|All Study Participants|tDCS: comparing anodal, cathodal, and sham tDCS
21653|NCT02539797|P3|Participant Flow|Sham Anodal Cathodal|sham stimulation, followed by anodal stimulation, followed by cathodal stimulation
21654|NCT02539797|P2|Participant Flow|Cathodal Sham Anodal|cathodal stimulation, followed by sham stimulation, followed by anodal stimulation
21655|NCT02539797|P1|Participant Flow|Anodal Cathodal Sham|anodal stimulation, followed by cathodal stimulation, followed by sham stimulation
21656|NCT02539797|O3|Outcome|Sham Stimulation|"Termination of electrical stimulation following 30 seconds~tDCS: comparing anodal, cathodal, and sham tDCS"
21657|NCT02539797|O2|Outcome|tDCS Cathodal Stimulation|"cathodal stimulation~tDCS: comparing anodal, cathodal, and sham tDCS"
21658|NCT02539797|O1|Outcome|tDCS Anodal Stimulation|"anodal stimulation~tDCS: comparing anodal, cathodal, and sham tDCS"
21659|NCT02539797|O3|Outcome|Sham Stimulation|"Termination of electrical stimulation following 30 seconds~tDCS: comparing anodal, cathodal, and sham tDCS"
21660|NCT02539797|O2|Outcome|tDCS Cathodal Stimulation|"cathodal stimulation~tDCS: comparing anodal, cathodal, and sham tDCS"
21661|NCT02539797|O1|Outcome|tDCS Anodal Stimulation|"anodal stimulation~tDCS: comparing anodal, cathodal, and sham tDCS"
21662|NCT02539797|E3|Reported Event|Sham Stimulation|"Termination of electrical stimulation following 30 seconds~tDCS: comparing anodal, cathodal, and sham tDCS"
21671|NCT02539134|B1|Baseline|Cohorts 1-5: Placebo|TAK-935 placebo-matching solution, orally, QD for up to 14 days in Cohorts 1, 2, and 5; BID for up to 10 days in Cohort 3 and QD for up to 10 days in Cohort 4.
21672|NCT02539134|P6|Participant Flow|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
21673|NCT02539134|P5|Participant Flow|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
21674|NCT02539134|P4|Participant Flow|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
21675|NCT02539134|P3|Participant Flow|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
21676|NCT02539134|P2|Participant Flow|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
21677|NCT02539134|P1|Participant Flow|Cohorts 1-5: Placebo|TAK-935 placebo-matching solution, orally, QD for up to 14 days in Cohorts 1, 2, and 5; BID for up to 10 days in Cohort 3 and QD for up to 10 days in Cohort 4.
21678|NCT02539134|O5|Outcome|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
21679|NCT02539134|O4|Outcome|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
21680|NCT02539134|O3|Outcome|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
21681|NCT02539134|O2|Outcome|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
21682|NCT02539134|O1|Outcome|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
21683|NCT02539134|O5|Outcome|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
21684|NCT02539134|O4|Outcome|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
21685|NCT02539134|O3|Outcome|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
21686|NCT02539134|O2|Outcome|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
21687|NCT02539134|O1|Outcome|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
21688|NCT02539134|O5|Outcome|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
21689|NCT02539134|O4|Outcome|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
21690|NCT02539134|O3|Outcome|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
21691|NCT02539134|O2|Outcome|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
21692|NCT02539134|O1|Outcome|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
21693|NCT02539134|O5|Outcome|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
21694|NCT02539134|O4|Outcome|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
21695|NCT02539134|O3|Outcome|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
21696|NCT02539134|O2|Outcome|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
21697|NCT02539134|O1|Outcome|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
21698|NCT02539134|O6|Outcome|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
21699|NCT02539134|O5|Outcome|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
21700|NCT02539134|O4|Outcome|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
21701|NCT02539134|O3|Outcome|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
21702|NCT02539134|O2|Outcome|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
21703|NCT02539134|O1|Outcome|Cohorts 1-5: Placebo|TAK-935 placebo-matching solution, orally, QD for up to 14 days in Cohorts 1, 2, and 5; BID for up to 10 days in Cohort 3 and QD for up to 10 days in Cohort 4.
21704|NCT02539134|O6|Outcome|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
21705|NCT02539134|O5|Outcome|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
21706|NCT02539134|O4|Outcome|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
21707|NCT02539134|O3|Outcome|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
21708|NCT02539134|O2|Outcome|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
21709|NCT02539134|O1|Outcome|Cohorts 1-5: Placebo|TAK-935 placebo-matching solution, orally, QD for up to 14 days in Cohorts 1, 2, and 5; BID for up to 10 days in Cohort 3 and QD for up to 10 days in Cohort 4.
21710|NCT02539134|O6|Outcome|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
21711|NCT02539134|O5|Outcome|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
21712|NCT02539134|O4|Outcome|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
21713|NCT02539134|O3|Outcome|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
21714|NCT02539134|O2|Outcome|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
21715|NCT02539134|O1|Outcome|Cohorts 1-5: Placebo|TAK-935 placebo-matching solution, orally, QD for up to 14 days in Cohorts 1, 2, and 5; BID for up to 10 days in Cohort 3 and QD for up to 10 days in Cohort 4.
21716|NCT02539134|O6|Outcome|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
21717|NCT02539134|O5|Outcome|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
21718|NCT02539134|O4|Outcome|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
21719|NCT02539134|O3|Outcome|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
21721|NCT02539134|O1|Outcome|Cohorts 1-5: Placebo|TAK-935 placebo-matching solution, orally, QD for up to 14 days in Cohorts 1, 2, and 5; BID for up to 10 days in Cohort 3 and QD for up to 10 days in Cohort 4.
21722|NCT02539134|E6|Reported Event|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
21723|NCT02539134|E5|Reported Event|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
21724|NCT02539134|E4|Reported Event|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
21725|NCT02539134|E3|Reported Event|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
21726|NCT02539134|E2|Reported Event|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
21727|NCT02539134|E1|Reported Event|Cohorts 1-5: Placebo|TAK-935 placebo-matching solution, orally, QD for up to 14 days in Cohorts 1, 2, and 5; BID for up to 10 days in Cohort 3 and QD for up to 10 days in Cohort 4.
21728|NCT02539108|B3|Baseline|Total|Total of all reporting groups
21729|NCT02539108|B2|Baseline|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
21730|NCT02539108|B1|Baseline|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
21731|NCT02539108|P2|Participant Flow|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
21732|NCT02539108|P1|Participant Flow|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
21733|NCT02539108|O2|Outcome|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
21734|NCT02539108|O1|Outcome|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
21735|NCT02539108|O2|Outcome|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
21736|NCT02539108|O1|Outcome|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
21737|NCT02539108|O2|Outcome|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
21738|NCT02539108|O1|Outcome|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
21739|NCT02539108|O2|Outcome|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
21740|NCT02539108|O1|Outcome|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
21741|NCT02539108|O2|Outcome|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
21742|NCT02539108|O1|Outcome|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
21743|NCT02539108|E2|Reported Event|3 to <9 Years of Age|Children 3 to < 9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
21744|NCT02539108|E1|Reported Event|6 to <36 Months of Age|Children 6 to < 36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
21745|NCT02538679|B4|Baseline|Total|Total of all reporting groups
21746|NCT02538679|B3|Baseline|Lap TAP Bupivacaine/Epinephrine|"Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.~Lap TAP Bupivacaine/Epinephrine: Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane."
21747|NCT02538679|B2|Baseline|US TAP Bupivacaine/Epinephrine|"Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.~US TAP Bupivacaine/Epinephrine: Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane."
21748|NCT02538679|B1|Baseline|PLACEBO|"No TAP block performed~Placebo: The usual intraoperative and postoperative pain control; NO TAP block performed"
21749|NCT02538679|P3|Participant Flow|Lap TAP Bupivacaine/Epinephrine|"Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.~Lap TAP Bupivacaine/Epinephrine: Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane."
21750|NCT02538679|P2|Participant Flow|US TAP Bupivacaine/Epinephrine|"Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.~US TAP Bupivacaine/Epinephrine: Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane."
21751|NCT02538679|P1|Participant Flow|PLACEBO|"No TAP block performed~Placebo: The usual intraoperative and postoperative pain control; NO TAP block performed"
21752|NCT02538679|O3|Outcome|Lap TAP Bupivacaine/Epinephrine|"Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.~Lap TAP Bupivacaine/Epinephrine: Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane."
21753|NCT02538679|O2|Outcome|US TAP Bupivacaine/Epinephrine|"Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.~US TAP Bupivacaine/Epinephrine: Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane."
21754|NCT02538679|O1|Outcome|PLACEBO|"No TAP block performed~Placebo: The usual intraoperative and postoperative pain control; NO TAP block performed"
21755|NCT02538679|E3|Reported Event|Lap TAP Bupivacaine/Epinephrine|"Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.~Lap TAP Bupivacaine/Epinephrine: Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane."
21756|NCT02538679|E2|Reported Event|US TAP Bupivacaine/Epinephrine|"Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.~US TAP Bupivacaine/Epinephrine: Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane."
21757|NCT02538679|E1|Reported Event|PLACEBO|"No TAP block performed~Placebo: The usual intraoperative and postoperative pain control; NO TAP block performed"
21758|NCT02538107|B1|Baseline|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
21759|NCT02538107|P1|Participant Flow|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
21760|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
21761|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
21762|NCT02538107|O2|Outcome|GFR (30-60 mL/Min)-Kidney Transplant Participants|Participants with GFR in the range of 30-60 mL/min with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
21763|NCT02538107|O1|Outcome|GFR (<30 mL/Min)-Kidney Transplant Participants|Participants with GFR <30 mL/min with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
21764|NCT02538107|O2|Outcome|Presence of Acute Bleeding-Kidney Transplant Participants|Participants with presence of acute bleeding episodes during the study with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
21765|NCT02538107|O1|Outcome|Absence of Acute Bleeding-Kidney Transplant Participants|Participants with absence of acute bleeding episodes during the study with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
21766|NCT02538107|O2|Outcome|Other Reason-Kidney Transplant Participants|Participants with unspecified other reasons as the cause of chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
21767|NCT02538107|O1|Outcome|Glomerulonephritis-Kidney Transplant Participants|Participants with glomerulonephritis as the cause of chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
21768|NCT02538107|O2|Outcome|Inflammatory Diseases Absent-Kidney Transplant Participants|Participants with chronic kidney disease and absence of other inflammatory diseases at baseline who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
21769|NCT02538107|O1|Outcome|Inflammatory Diseases Present-Kidney Transplant Participants|Participants with chronic kidney disease and presence of other inflammatory diseases at baseline who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
21770|NCT02538107|O2|Outcome|Cadaveric Donation-Kidney Transplant Participants|Participants with chronic kidney disease who underwent 'cadaveric donation' type of kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
21771|NCT02538107|O1|Outcome|Living Donation-Kidney Transplant Participants|Participants with chronic kidney disease who underwent 'living donation' type of kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
21875|NCT02535416|P5|Participant Flow|ARC-520 Cohort 4|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine
21772|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
21773|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
21774|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
21775|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
21776|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
21777|NCT02538107|E1|Reported Event|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
21778|NCT02537730|B1|Baseline|Overall Participants|Participants were randomized to the Bioclean MPS VII / comfilcon A combination or Aosept Clearcare / comfilcon A combination for one week, then cross over to the alternative combination.
21779|NCT02537730|P2|Participant Flow|Aosept Clearcare Combo, Then Bioclean MPS VII Combo|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week then cross over to the alternative Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination.~Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system~Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system~comfilcon A: contact lens"
21780|NCT02537730|P1|Participant Flow|Bioclean MPS VII Combo, Then Aosept Clearcare Combo|"Participants were randomized to the Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination for one week, then cross over to the alternative Aosept Clearcare / comfilcon A combination~Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system~Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system~comfilcon A: contact lens"
21781|NCT02537730|O2|Outcome|Aosept Clearcare / Comfilcon A Combination|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.~Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system~comfilcon A: contact lens"
21782|NCT02537730|O1|Outcome|Bioclean MPS VII / Comfilcon A Combination|"Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.~Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system~comfilcon A: contact lens"
21783|NCT02537730|O2|Outcome|Aosept Clearcare / Comfilcon A Combination|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.~Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system~comfilcon A: contact lens"
21784|NCT02537730|O1|Outcome|Bioclean MPS VII / Comfilcon A Combination|"Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.~Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system~comfilcon A: contact lens"
21785|NCT02537730|O2|Outcome|Aosept Clearcare / Comfilcon A Combination|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.~Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system~comfilcon A: contact lens"
21786|NCT02537730|O1|Outcome|Bioclean MPS VII / Comfilcon A Combination|"Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.~Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system~comfilcon A: contact lens"
21787|NCT02537730|O2|Outcome|Aosept Clearcare / Comfilcon A Combination|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.~Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system~comfilcon A: contact lens"
21788|NCT02537730|O1|Outcome|Bioclean MPS VII / Comfilcon A Combination|"Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.~Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system~comfilcon A: contact lens"
21789|NCT02537730|E2|Reported Event|Aosept Clearcare / Comfilcon A Combination|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.~Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system~comfilcon A: contact lens"
21790|NCT02537730|E1|Reported Event|Bioclean MPS VII / Comfilcon A Combination|"Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.~Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system~comfilcon A: contact lens"
21791|NCT02537522|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens throughout the course of the study.
21792|NCT02537522|P4|Participant Flow|Control/Test - Phase 2|Subjects randomized to this sequence in Phase II wore the narafilcon A lens with 9.0 Base Curve in both eyes and then wore narafilcon A lens with 8.5 Base Curve in both eyes.
21793|NCT02537522|P3|Participant Flow|Test/Control - Phase 2|Subjects randomized to this sequence in Phase II wore the narafilcon A lens with 8.5 Base Curve in both eyes and then wore narafilcon A lens with 9.0 Base Curve in both eyes.
21794|NCT02537522|P2|Participant Flow|Control/Test - Phase 1|Subjects randomized to this sequence in Phase I wore the test lens narafilcon A with 9.0 Base Curve in their left eye and then wore the narafilcon A with 8.5 Base Curve in their right eye.
21795|NCT02537522|P1|Participant Flow|Test/Control - Phase 1|Subjects randomized to this sequence in Phase I wore the test lens narafilcon A with 8.5 Base Curve in their left eye and then wore the narafilcon A with 9.0 Base Curve in their right eye.
21796|NCT02537522|O2|Outcome|Narafilcon A- 9.0 Base Curve|Subjects that wore the narafilcon A lens with 9.0 Base Curve in either the 1st or 2nd period of the study during either Phase II.
36440|NCT02389088|O4|Outcome|Phase I - Week 6 - 0 Hour|
21797|NCT02537522|O1|Outcome|Narafilcon A- 8.5 Base Curve|Subjects that wore the narafilcon A lens with 8.5 Base Curve in either the 1st or 2nd period of the study during either Phase II.
21798|NCT02537522|O2|Outcome|Narafilcon A- 9.0 Base Curve|Subjects that wore the narafilcon A lens with 9.0 Base Curve in either the 1st or 2nd period of the study during either Phase II.
21799|NCT02537522|O1|Outcome|Narafilcon A- 8.5 Base Curve|Subjects that wore the narafilcon A lens with 8.5 Base Curve in either the 1st or 2nd period of the study during either Phase II.
21800|NCT02537522|E2|Reported Event|Narafilcon A- 9.0 Base Curve|Subjects that wore the narafilcon A lens with 9.0 Base Curve in either the 1st or 2nd period of the study during either Phase II.
21801|NCT02537522|E1|Reported Event|Narafilcon A- 8.5 Base Curve|Subjects that wore the narafilcon A lens with 8.5 Base Curve in either the 1st or 2nd period of the study during either Phase II.
21802|NCT02536781|B3|Baseline|Total|Total of all reporting groups
21803|NCT02536781|B2|Baseline|Anthocynin|"Anthocyanin gel~Placebo: Blank gel"
21804|NCT02536781|B1|Baseline|Placebol|"Blank gel~Anthocyanin: Anti-inflammation gel"
21805|NCT02536781|P2|Participant Flow|Anthocynin|Mucoadhesive gel containing 10% of anthocyanin complex. Apply 2 times daily (Morning and night)
21806|NCT02536781|P1|Participant Flow|Placebo|Mucoadhesive gel without any drug or treatment. Apply 2 time daily (Morning and Night)
21807|NCT02536781|O2|Outcome|Anthocynin|"Anthocyanin gel~Placebo: Blank gel"
21808|NCT02536781|O1|Outcome|Placebol|"Blank gel~Anthocyanin: Anti-inflammation gel"
21809|NCT02536781|O2|Outcome|Anthocynin|"Anthocyanin gel~Placebo: Blank gel"
21810|NCT02536781|O1|Outcome|Placebol|"Blank gel~Anthocyanin: Anti-inflammation gel"
21811|NCT02536781|E2|Reported Event|Anthocynin|"Anthocyanin gel~Anti-inflammation gel"
21812|NCT02536781|E1|Reported Event|Placebol|"Placebo gel~Placebo gel"
21813|NCT02536664|B3|Baseline|Total|Total of all reporting groups
21814|NCT02536664|B2|Baseline|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
21815|NCT02536664|B1|Baseline|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
21816|NCT02536664|P2|Participant Flow|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
21817|NCT02536664|P1|Participant Flow|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the cluster of differentiation (CD) 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
21818|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
21819|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
21820|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
21821|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
21822|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
21823|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
21824|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
21825|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
21826|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
21827|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
21828|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
21829|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
21830|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
22276|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
21831|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
21832|NCT02536664|E2|Reported Event|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
21833|NCT02536664|E1|Reported Event|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
21834|NCT02536313|B3|Baseline|Total|Total of all reporting groups
21835|NCT02536313|B2|Baseline|SOF/VEL/VOX + RBV|SOF/VEL/VOX (400/100/100 mg) FDC tablet + RBV (1000 or 1200 mg daily based on weight) tablet orally once daily with food for 12 weeks
21836|NCT02536313|B1|Baseline|SOF/VEL/VOX|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
21837|NCT02536313|P2|Participant Flow|SOF/VEL/VOX + RBV|SOF/VEL/VOX (400/100/100 mg) FDC tablet + Ribavirin (RBV) (1000 or 1200 mg daily based on weight) tablet orally once daily with food for 12 weeks
21838|NCT02536313|P1|Participant Flow|SOF/VEL/VOX|Sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX ) (400/100/100 mg) fixed dose combination (FDC) tablet orally once daily with food for 12 weeks
21839|NCT02536313|O2|Outcome|SOF/VEL/VOX + RBV|SOF/VEL/VOX (400/100/100 mg) FDC tablet + RBV (1000 or 1200 mg daily based on weight) tablet orally once daily with food for 12 weeks
21840|NCT02536313|O1|Outcome|SOF/VEL/VOX|SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily with food for 12 weeks
21841|NCT02536313|O2|Outcome|SOF/VEL/VOX + RBV|SOF/VEL/VOX (400/100/100 mg) FDC tablet + RBV (1000 or 1200 mg daily based on weight) tablet orally once daily with food for 12 weeks
21842|NCT02536313|O1|Outcome|SOF/VEL/VOX|SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily with food for 12 weeks
21843|NCT02536313|O2|Outcome|SOF/VEL/VOX + RBV|SOF/VEL/VOX (400/100/100 mg) FDC tablet + RBV (1000 or 1200 mg daily based on weight) tablet once daily with food for 12 weeks
21844|NCT02536313|O1|Outcome|SOF/VEL/VOX|SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily with food for 12 weeks
21845|NCT02536313|O2|Outcome|SOF/VEL/VOX + RBV|SOF/VEL/VOX (400/100/100 mg) FDC tablet + RBV (1000 or 1200 mg daily based on weight) tablet once daily with food for 12 weeks
21846|NCT02536313|O1|Outcome|SOF/VEL/VOX|SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily with food for 12 weeks
21847|NCT02536313|O2|Outcome|SOF/VEL/VOX + RBV|SOF/VEL/VOX (400/100/100 mg) FDC tablet + RBV (1000 or 1200 mg daily based on weight) tablet orally once daily with food for 12 weeks
21848|NCT02536313|O1|Outcome|SOF/VEL/VOX|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
21849|NCT02536313|O2|Outcome|SOF/VEL/VOX + RBV|SOF/VEL/VOX (400/100/100 mg) FDC tablet + RBV (1000 or 1200 mg daily based on weight) tablet orally once daily with food for 12 weeks
21850|NCT02536313|O1|Outcome|SOF/VEL/VOX|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
21851|NCT02536313|E2|Reported Event|SOF/VEL/VOX + RBV|SOF/VEL/VOX (400/100/100 mg) tablet + RBV (1000 or 1200 mg daily based on weight) tablet orally once daily for 12 weeks
21852|NCT02536313|E1|Reported Event|SOF/VEL/VOX|SOF/VEL/VOX (400/100/100 mg) tablet orally once daily for 12 weeks
21853|NCT02535741|B1|Baseline|Triathlon CR Total Knee System|Progressive data: Primary total knee replacement
21854|NCT02535741|P1|Participant Flow|Triathlon CR Total Knee System|"Primary total knee replacement~Triathlon CR Total Knee System: Primary total knee replacement"
21855|NCT02535741|O1|Outcome|Triathlon CR Total Knee System|"Primary total knee replacement~Triathlon CR Total Knee System: Primary total knee replacement"
21856|NCT02535741|O1|Outcome|Triathlon CR Total Knee System|"Primary total knee replacement~Triathlon CR Total Knee System: Primary total knee replacement"
21857|NCT02535741|O1|Outcome|Triathlon CR Total Knee System|Prospective data of the Triathlon CR primary total knee replacement
21858|NCT02535741|O1|Outcome|Triathlon CR Total Knee System|"Primary total knee replacement~Triathlon CR Total Knee System: Primary total knee replacement"
21859|NCT02535741|O1|Outcome|Triathlon CR Total Knee System|Prospective data of the Triathlon CR primary total knee replacement
21860|NCT02535741|E1|Reported Event|Triathlon CR Total Knee System|Triathlon CR Primary total knee replacement
21861|NCT02535416|B10|Baseline|Total|Total of all reporting groups
21862|NCT02535416|B9|Baseline|ARC-520 Cohort 8|Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
21863|NCT02535416|B8|Baseline|ARC-520 Cohort 7|Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
21864|NCT02535416|B7|Baseline|ARC-520 Cohort 6|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
21865|NCT02535416|B6|Baseline|ARC-520 Cohort 5|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine
21866|NCT02535416|B5|Baseline|ARC-520 Cohort 4|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine
21867|NCT02535416|B4|Baseline|ARC-520 Cohort 3|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
21868|NCT02535416|B3|Baseline|ARC-520 Cohort 2|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine
21869|NCT02535416|B2|Baseline|ARC-520 Cohort 2A|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine
21870|NCT02535416|B1|Baseline|ARC-520 Cohort 1|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine
21871|NCT02535416|P9|Participant Flow|ARC-520 Cohort 8|Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
21872|NCT02535416|P8|Participant Flow|ARC-520 Cohort 7|Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
21873|NCT02535416|P7|Participant Flow|ARC-520 Cohort 6|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
21874|NCT02535416|P6|Participant Flow|ARC-520 Cohort 5|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine
21876|NCT02535416|P4|Participant Flow|ARC-520 Cohort 3|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
21877|NCT02535416|P3|Participant Flow|ARC-520 Cohort 2|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine
21878|NCT02535416|P2|Participant Flow|ARC-520 Cohort 2A|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine
21879|NCT02535416|P1|Participant Flow|ARC-520 Cohort 1|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine
21880|NCT02535416|O4|Outcome|ARC-520 Cohort 8|Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
21881|NCT02535416|O3|Outcome|ARC-520 Cohort 7|Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
21882|NCT02535416|O2|Outcome|ARC-520 Cohort 6|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
21883|NCT02535416|O1|Outcome|ARC-520 Cohort 3|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
21884|NCT02535416|O4|Outcome|ARC-520 Cohort 8|Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
21885|NCT02535416|O3|Outcome|ARC-520 Cohort 7|Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
21886|NCT02535416|O2|Outcome|ARC-520 Cohort 6|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
21887|NCT02535416|O1|Outcome|ARC-520 Cohort 3|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
21888|NCT02535416|O4|Outcome|ARC-520 Cohort 8|Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
21889|NCT02535416|O3|Outcome|ARC-520 Cohort 7|Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
21890|NCT02535416|O2|Outcome|ARC-520 Cohort 6|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
21891|NCT02535416|O1|Outcome|ARC-520 Cohort 3|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
21892|NCT02535416|O4|Outcome|ARC-520 Cohort 8|Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
21893|NCT02535416|O3|Outcome|ARC-520 Cohort 7|Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
21894|NCT02535416|O2|Outcome|ARC-520 Cohort 6|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
21895|NCT02535416|O1|Outcome|ARC-520 Cohort 3|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
21896|NCT02535416|O4|Outcome|ARC-520 Cohort 8|Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
21897|NCT02535416|O3|Outcome|ARC-520 Cohort 7|Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
21898|NCT02535416|O2|Outcome|ARC-520 Cohort 6|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
21899|NCT02535416|O1|Outcome|ARC-520 Cohort 3|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
21900|NCT02535416|O4|Outcome|ARC-520 Cohort 8|Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
21901|NCT02535416|O3|Outcome|ARC-520 Cohort 7|Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
21902|NCT02535416|O2|Outcome|ARC-520 Cohort 6|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
21903|NCT02535416|O1|Outcome|ARC-520 Cohort 3|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
21904|NCT02535416|O4|Outcome|ARC-520 Cohort 8|Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
21905|NCT02535416|O3|Outcome|ARC-520 Cohort 7|Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
21906|NCT02535416|O2|Outcome|ARC-520 Cohort 6|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
21907|NCT02535416|O1|Outcome|ARC-520 Cohort 3|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
21908|NCT02535416|O4|Outcome|ARC-520 Cohort 8|Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
21909|NCT02535416|O3|Outcome|ARC-520 Cohort 7|Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
21910|NCT02535416|O2|Outcome|ARC-520 Cohort 6|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
21911|NCT02535416|O1|Outcome|ARC-520 Cohort 3|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
21912|NCT02535416|O9|Outcome|ARC-520 Cohort 8|Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
21913|NCT02535416|O8|Outcome|ARC-520 Cohort 7|Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
21914|NCT02535416|O7|Outcome|ARC-520 Cohort 6|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
21915|NCT02535416|O6|Outcome|ARC-520 Cohort 5|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine
21916|NCT02535416|O5|Outcome|ARC-520 Cohort 4|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine
21917|NCT02535416|O4|Outcome|ARC-520 Cohort 3|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
21918|NCT02535416|O3|Outcome|ARC-520 Cohort 2|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine
21919|NCT02535416|O2|Outcome|ARC-520 Cohort 2A|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine
21920|NCT02535416|O1|Outcome|ARC-520 Cohort 1|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine
21921|NCT02535416|E9|Reported Event|ARC-520 Cohort 8|Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
21922|NCT02535416|E8|Reported Event|ARC-520 Cohort 7|Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
21923|NCT02535416|E7|Reported Event|ARC-520 Cohort 6|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
21924|NCT02535416|E6|Reported Event|ARC-520 Cohort 5|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine
21925|NCT02535416|E5|Reported Event|ARC-520 Cohort 4|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine
21926|NCT02535416|E4|Reported Event|ARC-520 Cohort 3|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
21927|NCT02535416|E3|Reported Event|ARC-520 Cohort 2|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine
21928|NCT02535416|E2|Reported Event|ARC-520 Cohort 2A|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine
21929|NCT02535416|E1|Reported Event|ARC-520 Cohort 1|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine
21930|NCT02535026|B1|Baseline|Breast Cancer Participants|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
21931|NCT02535026|P1|Participant Flow|Breast Cancer (BC) Participants|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
21932|NCT02535026|O4|Outcome|BC Participants-Triple Negative Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
21933|NCT02535026|O3|Outcome|BC Participants-HER2 Enriched Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
21934|NCT02535026|O2|Outcome|BC Participants-Luminal B Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal B phenotype were included in this group.
21935|NCT02535026|O1|Outcome|BC Participants-Luminal A Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal A phenotype were included in this group.
21936|NCT02535026|O4|Outcome|BC Participants-Triple Negative Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
21937|NCT02535026|O3|Outcome|BC Participants-HER2 Enriched Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
21938|NCT02535026|O2|Outcome|BC Participants-Luminal B Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal B phenotype were included in this group.
21939|NCT02535026|O1|Outcome|BC Participants-Luminal A Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal A phenotype were included in this group.
21940|NCT02535026|O4|Outcome|BC Participants-Triple Negative Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
21941|NCT02535026|O3|Outcome|BC Participants-HER2 Enriched Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
21942|NCT02535026|O2|Outcome|BC Participants-Luminal B Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal B phenotype were included in this group.
21943|NCT02535026|O1|Outcome|BC Participants-Luminal A Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal A phenotype were included in this group.
21944|NCT02535026|O4|Outcome|BC Participants-Triple Negative Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
21945|NCT02535026|O3|Outcome|BC Participants-HER2 Enriched Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
21946|NCT02535026|O2|Outcome|BC Participants-Luminal B Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal B phenotype were included in this group.
21947|NCT02535026|O1|Outcome|BC Participants-Luminal A Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal A phenotype were included in this group.
21948|NCT02535026|O4|Outcome|BC Participants-Triple Negative Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
21949|NCT02535026|O3|Outcome|BC Participants-HER2 Enriched Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
22148|NCT02534493|O2|Outcome|Unilateral Only|The CTMD was worn for a duration of 8-10 hours daily over the treatment period. Unilateral subjects wore the CTMD on the single affected wrist.
21950|NCT02535026|O2|Outcome|BC Participants-Luminal B Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal B phenotype were included in this group.
21951|NCT02535026|O1|Outcome|BC Participants-Luminal A Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal A phenotype were included in this group.
21952|NCT02535026|O4|Outcome|BC Participants-Triple Negative Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
21953|NCT02535026|O3|Outcome|BC Participants-HER2 Enriched Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
21954|NCT02535026|O2|Outcome|BC Participants-Luminal B Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal B phenotype were included in this group.
21955|NCT02535026|O1|Outcome|BC Participants-Luminal A Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal A phenotype were included in this group.
21956|NCT02535026|O4|Outcome|BC Participants-Triple Negative Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
21957|NCT02535026|O3|Outcome|BC Participants-HER2 Enriched Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
21958|NCT02535026|O2|Outcome|BC Participants-Luminal B Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal B phenotype were included in this group.
21959|NCT02535026|O1|Outcome|BC Participants-Luminal A Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal A phenotype were included in this group.
21960|NCT02535026|O2|Outcome|Breast Cancer Participants (HER2+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2+ status were included in this group.
21961|NCT02535026|O1|Outcome|Breast Cancer Participants (HER2-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2- status were included in this group.
21962|NCT02535026|O2|Outcome|Breast Cancer Participants (HER2+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2+ status were included in this group.
21963|NCT02535026|O1|Outcome|Breast Cancer Participants (HER2-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2- status were included in this group.
21964|NCT02535026|O2|Outcome|Breast Cancer Participants (HER2+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2+ status were included in this group.
21965|NCT02535026|O1|Outcome|Breast Cancer Participants (HER2-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2- status were included in this group.
21966|NCT02535026|O2|Outcome|Breast Cancer Participants (PR+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with PR+ status were included in this group.
21967|NCT02535026|O1|Outcome|Breast Cancer Participants (PR-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with PR- status were included in this group.
21968|NCT02535026|O2|Outcome|Breast Cancer Participants (PR+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with PR+ status were included in this group.
21969|NCT02535026|O1|Outcome|Breast Cancer Participants (PR-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with PR- status were included in this group.
21970|NCT02535026|O2|Outcome|Breast Cancer Participants (PR+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with PR+ status were included in this group.
21971|NCT02535026|O1|Outcome|Breast Cancer Participants (PR-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with PR- status were included in this group.
21972|NCT02535026|O2|Outcome|Breast Cancer Participants (ER+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
21973|NCT02535026|O1|Outcome|Breast Cancer Participants (ER-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER- status were included in this group.
21974|NCT02535026|O2|Outcome|Breast Cancer Participants (ER+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
21975|NCT02535026|O1|Outcome|Breast Cancer Participants (ER-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER- status were included in this group.
21976|NCT02535026|O2|Outcome|Breast Cancer Participants (ER+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
21977|NCT02535026|O1|Outcome|Breast Cancer Participants (ER-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER- status were included in this group.
21978|NCT02535026|O1|Outcome|Breast Cancer Participants|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
21979|NCT02535026|O1|Outcome|Breast Cancer Participants|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
21980|NCT02535026|O1|Outcome|Breast Cancer Participants|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
21981|NCT02535026|E1|Reported Event|Breast Cancer Participants|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
21982|NCT02534935|B4|Baseline|Total|Total of all reporting groups
21983|NCT02534935|B3|Baseline|Group 3: HAV/Saline (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
21984|NCT02534935|B2|Baseline|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
21985|NCT02534935|B1|Baseline|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
21986|NCT02534935|P3|Participant Flow|Group 3: HAV/Saline (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
21987|NCT02534935|P2|Participant Flow|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
21988|NCT02534935|P1|Participant Flow|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from greater than equal to (>=) 12 months to <24 months of age, received intramuscular injection of 60 microgram (µg) of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
21989|NCT02534935|O9|Outcome|Group 3: HAV/Saline (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
21990|NCT02534935|O8|Outcome|Group 3: HAV/Saline (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
21991|NCT02534935|O7|Outcome|Group 3: HAV/Saline (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
21992|NCT02534935|O6|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
21993|NCT02534935|O5|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
21994|NCT02534935|O4|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
21995|NCT02534935|O3|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
21996|NCT02534935|O2|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
21997|NCT02534935|O1|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
21998|NCT02534935|O9|Outcome|Group 3: HAV/Saline (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
21999|NCT02534935|O8|Outcome|Group 3: HAV/Saline (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22000|NCT02534935|O7|Outcome|Group 3: HAV/Saline (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22001|NCT02534935|O6|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22002|NCT02534935|O5|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22003|NCT02534935|O4|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22004|NCT02534935|O3|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22005|NCT02534935|O2|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22006|NCT02534935|O1|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22007|NCT02534935|O9|Outcome|Group 3: HAV/Saline (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22008|NCT02534935|O8|Outcome|Group 3: HAV/Saline (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22009|NCT02534935|O7|Outcome|Group 3: HAV/Saline (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22010|NCT02534935|O6|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22011|NCT02534935|O5|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22012|NCT02534935|O4|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22013|NCT02534935|O3|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22014|NCT02534935|O2|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22015|NCT02534935|O1|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22016|NCT02534935|O3|Outcome|Group 3: HAV/Saline (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22017|NCT02534935|O2|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22018|NCT02534935|O1|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22019|NCT02534935|O9|Outcome|Group 3: HAV/Saline (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22020|NCT02534935|O8|Outcome|Group 3: HAV/Saline (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22021|NCT02534935|O7|Outcome|Group 3: HAV/Saline (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22022|NCT02534935|O6|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22023|NCT02534935|O5|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22024|NCT02534935|O4|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22025|NCT02534935|O3|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22026|NCT02534935|O2|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22027|NCT02534935|O1|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22028|NCT02534935|O9|Outcome|Group 3: HAV/Saline (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22029|NCT02534935|O8|Outcome|Group 3: HAV/Saline (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22030|NCT02534935|O7|Outcome|Group 3: HAV/Saline (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22031|NCT02534935|O6|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22032|NCT02534935|O5|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22277|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
22278|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
22033|NCT02534935|O4|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22034|NCT02534935|O3|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22035|NCT02534935|O2|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22036|NCT02534935|O1|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22037|NCT02534935|O9|Outcome|Group 3: HAV/Saline (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22038|NCT02534935|O8|Outcome|Group 3: HAV/Saline (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22039|NCT02534935|O7|Outcome|Group 3: HAV/Saline (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22040|NCT02534935|O6|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22041|NCT02534935|O5|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22042|NCT02534935|O4|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22043|NCT02534935|O3|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22044|NCT02534935|O2|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22045|NCT02534935|O1|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22046|NCT02534935|O9|Outcome|Group 3: HAV/Saline (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22047|NCT02534935|O8|Outcome|Group 3: HAV/Saline (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22048|NCT02534935|O7|Outcome|Group 3: HAV/Saline (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22049|NCT02534935|O6|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22050|NCT02534935|O5|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22051|NCT02534935|O4|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22052|NCT02534935|O3|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22053|NCT02534935|O2|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22054|NCT02534935|O1|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22055|NCT02534935|O9|Outcome|Group 3: HAV/Saline (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22056|NCT02534935|O8|Outcome|Group 3: HAV/Saline (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22057|NCT02534935|O7|Outcome|Group 3: HAV/Saline (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22058|NCT02534935|O6|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22059|NCT02534935|O5|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22060|NCT02534935|O4|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22061|NCT02534935|O3|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22279|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
36441|NCT02389088|O3|Outcome|Phase I - Week 5 - 24 Hour|
22062|NCT02534935|O2|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22063|NCT02534935|O1|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22064|NCT02534935|O9|Outcome|Group 3: HAV/Saline (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22065|NCT02534935|O8|Outcome|Group 3: HAV/Saline (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22066|NCT02534935|O7|Outcome|Group 3: HAV/Saline (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22067|NCT02534935|O6|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22068|NCT02534935|O5|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22069|NCT02534935|O4|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22070|NCT02534935|O3|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22071|NCT02534935|O2|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22072|NCT02534935|O1|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22073|NCT02534935|O9|Outcome|Group 3: HAV/Saline (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22074|NCT02534935|O8|Outcome|Group 3: HAV/Saline (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22075|NCT02534935|O7|Outcome|Group 3: HAV/Saline (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22076|NCT02534935|O6|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22077|NCT02534935|O5|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22078|NCT02534935|O4|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22079|NCT02534935|O3|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22080|NCT02534935|O2|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22081|NCT02534935|O1|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22082|NCT02534935|O9|Outcome|Group 3: HAV/Saline (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22083|NCT02534935|O8|Outcome|Group 3: HAV/Saline (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22084|NCT02534935|O7|Outcome|Group 3: HAV/Saline (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22085|NCT02534935|O6|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22086|NCT02534935|O5|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22087|NCT02534935|O4|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22088|NCT02534935|O3|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22089|NCT02534935|O2|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22090|NCT02534935|O1|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22280|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
22091|NCT02534935|O9|Outcome|Group 3: HAV/Saline (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22092|NCT02534935|O8|Outcome|Group 3: HAV/Saline (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22093|NCT02534935|O7|Outcome|Group 3: HAV/Saline (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22094|NCT02534935|O6|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22095|NCT02534935|O5|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22096|NCT02534935|O4|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22097|NCT02534935|O3|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22098|NCT02534935|O2|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22099|NCT02534935|O1|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22100|NCT02534935|O9|Outcome|Group 3: HAV/Saline (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22101|NCT02534935|O8|Outcome|Group 3: HAV/Saline (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22102|NCT02534935|O7|Outcome|Group 3: HAV/Saline (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22103|NCT02534935|O6|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22104|NCT02534935|O5|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22105|NCT02534935|O4|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22106|NCT02534935|O3|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22107|NCT02534935|O2|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22108|NCT02534935|O1|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22109|NCT02534935|O9|Outcome|Group 3: HAV/Saline (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22110|NCT02534935|O8|Outcome|Group 3: HAV/Saline (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22111|NCT02534935|O7|Outcome|Group 3: HAV/Saline (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22112|NCT02534935|O6|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22113|NCT02534935|O5|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22114|NCT02534935|O4|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22115|NCT02534935|O3|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22116|NCT02534935|O2|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22117|NCT02534935|O1|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22118|NCT02534935|O9|Outcome|Group 3: HAV/Saline (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22119|NCT02534935|O8|Outcome|Group 3: HAV/Saline (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22120|NCT02534935|O7|Outcome|Group 3: HAV/Saline (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22121|NCT02534935|O6|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22122|NCT02534935|O5|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22123|NCT02534935|O4|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22124|NCT02534935|O3|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22125|NCT02534935|O2|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22126|NCT02534935|O1|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22127|NCT02534935|O9|Outcome|Group 3: HAV/Saline (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22128|NCT02534935|O8|Outcome|Group 3: HAV/Saline (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22129|NCT02534935|O7|Outcome|Group 3: HAV/Saline (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22130|NCT02534935|O6|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22131|NCT02534935|O5|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22132|NCT02534935|O4|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22133|NCT02534935|O3|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22134|NCT02534935|O2|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22135|NCT02534935|O1|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22136|NCT02534935|O6|Outcome|Group 3: HAV/Saline (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22137|NCT02534935|O5|Outcome|Group 3: HAV/Saline (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22138|NCT02534935|O4|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22139|NCT02534935|O3|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22140|NCT02534935|O2|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22141|NCT02534935|O1|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22142|NCT02534935|E3|Reported Event|Group 3: HAV/Saline (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22143|NCT02534935|E2|Reported Event|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22144|NCT02534935|E1|Reported Event|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22145|NCT02534493|B1|Baseline|Carpal Tunnel Medical Device (CTMD)|"The Carpal Tunnel Tissue Manipulation Device (CTMD) is a piece of rigid, shaped, biocompatible plastic (polypropylene) rated for skin contact and a strong but safe hypoallergenic biocompatible medical adhesive which bonds the skin over the carpal tunnel to the plastic piece. The CTMD is worn for a duration of 8-10 hours daily over the treatment period.~If a participant had bilateral CTS, both wrists were treated but only the worst wrist (via NCS and BCTQ SSS score) was analyzed."
22146|NCT02534493|P1|Participant Flow|Carpal Tunnel Medical Device (CTMD)|"The Carpal Tunnel Tissue Manipulation Device (CTMD) is a piece of rigid, shaped, biocompatible plastic (polypropylene) rated for skin contact and a strong but safe hypoallergenic biocompatible medical adhesive which bonds the skin over the carpal tunnel to the plastic piece. The CTMD is worn for a duration of 8-10 hours daily over the treatment period.~If a participant had bilateral CTS, both wrists were treated but only the worst wrist (via NCS and BCTQ SSS score) was analyzed."
22147|NCT02534493|O3|Outcome|Bilateral Only|The CTMD was worn for a duration of 8-10 hours daily over the treatment period. Bilateral subjects wore the CTMD on both wrists, but only the worst wrist (via NCS and BCTQ SSS score) was analyzed.
36442|NCT02389088|O2|Outcome|Phase I - Week 5 - 0 Hour|
22149|NCT02534493|O1|Outcome|Unilateral+Bilateral|The CTMD was worn for a duration of 8-10 hours daily over the treatment period. Unilateral subjects wore the CTMD on the single affected wrist. Bilateral subjects wore the CTMD on both wrists, but only the worst wrist (via NCS and BCTQ SSS score) was analyzed.
22150|NCT02534493|O3|Outcome|Bilateral Only|The CTMD was worn for a duration of 8-10 hours daily over the treatment period. Bilateral subjects wore the CTMD on both wrists, but only the worst wrist (via NCS and BCTQ SSS score) was analyzed.
22151|NCT02534493|O2|Outcome|Unilateral Only|The CTMD was worn for a duration of 8-10 hours daily over the treatment period. Unilateral subjects wore the CTMD on the single affected wrist.
22152|NCT02534493|O1|Outcome|Unilateral+Bilateral|The CTMD was worn for a duration of 8-10 hours daily over the treatment period. Unilateral subjects wore the CTMD on the single affected wrist. Bilateral subjects wore the CTMD on both wrists, but only the worst wrist (via NCS and BCTQ SSS score) was analyzed.
22153|NCT02534493|E1|Reported Event|Carpal Tunnel Medical Device (CTMD)|"The Carpal Tunnel Tissue Manipulation Device (CTMD) is a piece of rigid, shaped, biocompatible plastic (polypropylene) rated for skin contact and a strong but safe hypoallergenic biocompatible medical adhesive which bonds the skin over the carpal tunnel to the plastic piece. The CTMD is worn for a duration of 8-10 hours daily over the treatment period.~If a participant had bilateral CTS, both wrists were treated but only the worst wrist (via NCS and BCTQ SSS score) was analyzed."
22154|NCT02534324|B3|Baseline|Total|Total of all reporting groups
22155|NCT02534324|B2|Baseline|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
22156|NCT02534324|B1|Baseline|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
22157|NCT02534324|P2|Participant Flow|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
22158|NCT02534324|P1|Participant Flow|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
22159|NCT02534324|O2|Outcome|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
22160|NCT02534324|O1|Outcome|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
22161|NCT02534324|O2|Outcome|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
22162|NCT02534324|O1|Outcome|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
22163|NCT02534324|O2|Outcome|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
22164|NCT02534324|O1|Outcome|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
22165|NCT02534324|E2|Reported Event|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
22166|NCT02534324|E1|Reported Event|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
22167|NCT02534129|B1|Baseline|Difinsa53 and Aquaphor Arms|"Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor~Difinsa53: Difinsa53 cream is applied to one half of radiation field~Aquaphor: Aquaphor is applied to one half of radiation field"
22168|NCT02534129|P2|Participant Flow|Difinsa53|This radiation field treated with Difinsa53
22169|NCT02534129|P1|Participant Flow|Aquaphor|This radiation field treated with aquaphor
22170|NCT02534129|O2|Outcome|Aquaphor Arm|"Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor~Aquaphor: Aquaphor is applied to one half of radiation field"
22171|NCT02534129|O1|Outcome|Difinsa 53 Arm|"Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor~Difinsa53: Difinsa53 cream is applied to one half of radiation field"
22172|NCT02534129|E2|Reported Event|Aquaphor Arm|"Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor~Aquaphor: Aquaphor is applied to one half of radiation field"
22173|NCT02534129|E1|Reported Event|Difinsa53 Arm|"Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor~Difinsa53: Difinsa53 cream is applied to one half of radiation field"
22174|NCT02533999|B3|Baseline|Total|Total of all reporting groups
22175|NCT02533999|B2|Baseline|Electrosurgery|"Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.~Electrosurgery: Surgical method for tonsillectomy and adenoidectomy."
22176|NCT02533999|B1|Baseline|Surgical Instrument|"PEAK® Plasma Surgery System [PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, “an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down”. The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.~PEAK® Plasma System: Surgical method for tonsillectomy and adenoidectomy."
22177|NCT02533999|P2|Participant Flow|Electrosurgery|"Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.~Electrosurgery: Surgical method for tonsillectomy and adenoidectomy."
22178|NCT02533999|P1|Participant Flow|Surgical Instrument|"PEAK® Plasma Surgery System [PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, “an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down”. The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.~PEAK® Plasma System: Surgical method for tonsillectomy and adenoidectomy."
22179|NCT02533999|O2|Outcome|Electrosurgery|"Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.~Electrosurgery: Surgical method for tonsillectomy and adenoidectomy."
22180|NCT02533999|O1|Outcome|Surgical Instrument|"PEAK® Plasma Surgery System [PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, “an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down”. The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.~PEAK® Plasma System: Surgical method for tonsillectomy and adenoidectomy."
22181|NCT02533999|O2|Outcome|Electrosurgery|"Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.~Electrosurgery: Surgical method for tonsillectomy and adenoidectomy."
22182|NCT02533999|O1|Outcome|Surgical Instrument|"PEAK® Plasma Surgery System [PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, “an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down”. The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.~PEAK® Plasma System: Surgical method for tonsillectomy and adenoidectomy."
22183|NCT02533999|O2|Outcome|Electrosurgery|"Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.~Electrosurgery: Surgical method for tonsillectomy and adenoidectomy."
22197|NCT02533726|B1|Baseline|Treatment - Optimal Turning|All patients had a sensor applied. Patients within this arm received care from nurses who had access to a User Dashboard that provided visual advisories for patient turning, based on data obtained from the wearable patient sensor.
22184|NCT02533999|O1|Outcome|Surgical Instrument|"PEAK® Plasma Surgery System [PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, “an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down”. The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.~PEAK® Plasma System: Surgical method for tonsillectomy and adenoidectomy."
22185|NCT02533999|O2|Outcome|Electrosurgery|"Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.~Electrosurgery: Surgical method for tonsillectomy and adenoidectomy."
22186|NCT02533999|O1|Outcome|Surgical Instrument|"PEAK® Plasma Surgery System [PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, “an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down”. The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.~PEAK® Plasma System: Surgical method for tonsillectomy and adenoidectomy."
22187|NCT02533999|O2|Outcome|Electrosurgery|"Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.~Electrosurgery: Surgical method for tonsillectomy and adenoidectomy."
22188|NCT02533999|O1|Outcome|Surgical Instrument|"PEAK® Plasma Surgery System [PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, “an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down”. The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.~PEAK® Plasma System: Surgical method for tonsillectomy and adenoidectomy."
22189|NCT02533999|O2|Outcome|Electrosurgery|"Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.~Electrosurgery: Surgical method for tonsillectomy and adenoidectomy."
22190|NCT02533999|O1|Outcome|Surgical Instrument|"PEAK® Plasma Surgery System [PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, “an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down”. The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.~PEAK® Plasma System: Surgical method for tonsillectomy and adenoidectomy."
22191|NCT02533999|O2|Outcome|Electrosurgery|"Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.~Electrosurgery: Surgical method for tonsillectomy and adenoidectomy."
22192|NCT02533999|O1|Outcome|Surgical Instrument|"PEAK® Plasma Surgery System [PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, “an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down”. The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.~PEAK® Plasma System: Surgical method for tonsillectomy and adenoidectomy."
22193|NCT02533999|E2|Reported Event|Electrosurgery|"Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.~Electrosurgery: Surgical method for tonsillectomy and adenoidectomy."
22194|NCT02533999|E1|Reported Event|Surgical Instrument|"PEAK® Plasma Surgery System [PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, “an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down”. The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.~PEAK® Plasma System: Surgical method for tonsillectomy and adenoidectomy."
22195|NCT02533726|B3|Baseline|Total|Total of all reporting groups
22196|NCT02533726|B2|Baseline|Control - Standard Care|All patients had a sensor applied. Patients within this arm received care from nurses who did not have access to a User Dashboard that provided visual advisories for patient turning. Instead, these patients received standard care practices, patient turning initiated by nurses as necessary.
22198|NCT02533726|P2|Participant Flow|Control - Standard Care|All patients had a sensor applied. Patients within this arm received care from nurses who did not have access to a User Dashboard that provided visual advisories for patient turning. Instead, these patients received standard care practices, patient turning initiated by nurses as necessary.
22199|NCT02533726|P1|Participant Flow|Treatment - Optimal Turning|All patients had a sensor applied. Patients within this arm received care from nurses who had access to a User Dashboard that provided visual advisories for patient turning, based on data obtained from the wearable patient sensor.
22200|NCT02533726|O2|Outcome|Control - Standard Care|All patients had a sensor applied. Patients within this arm received care from nurses who did not have access to a User Dashboard that provided visual advisories for patient turning. Instead, these patients received standard care practices, patient turning initiated by nurses as necessary.
22201|NCT02533726|O1|Outcome|Treatment - Optimal Turning|All patients had a sensor applied. Patients within this arm received care from nurses who had access to a User Dashboard that provided visual advisories for patient turning, based on data obtained from the wearable patient sensor.
22202|NCT02533726|O2|Outcome|Control - Standard Care|All patients had a sensor applied. Patients within this arm received care from nurses who did not have access to a User Dashboard that provided visual advisories for patient turning. Instead, these patients received standard care practices, patient turning initiated by nurses as necessary.
22203|NCT02533726|O1|Outcome|Treatment - Optimal Turning|All patients had a sensor applied. Patients within this arm received care from nurses who had access to a User Dashboard that provided visual advisories for patient turning, based on data obtained from the wearable patient sensor.
22204|NCT02533726|E2|Reported Event|Control - Standard Care|All patients had a sensor applied. Patients within this arm received care from nurses who did not have access to a User Dashboard that provided visual advisories for patient turning. Instead, these patients received standard care practices, patient turning initiated by nurses as necessary.
22205|NCT02533726|E1|Reported Event|Treatment - Optimal Turning|All patients had a sensor applied. Patients within this arm received care from nurses who had access to a User Dashboard that provided visual advisories for patient turning, based on data obtained from the wearable patient sensor.
22206|NCT02533531|B1|Baseline|1-Lead Outpatient Telemetry|"1-Lead Outpatient Patch study participants. Patients assigned to outpatient telemetry monitoring will receive the 1-Lead patch upon discharge from hospital inpatient status. ECG data will be submitted by the 1-lead patch to a central database.~1-Lead Patch: The 1-Lead Patch will record and transmit ECG data to a gateway, which will then transmit the data to a central database."
22207|NCT02533531|P1|Participant Flow|1-Lead Outpatient Telemetry|"1-Lead Outpatient Patch study participants. Patients assigned to outpatient telemetry monitoring will receive the 1-Lead patch upon discharge from hospital inpatient status. ECG data will be submitted by the 1-lead patch to a central database.~1-Lead Patch: The 1-Lead Patch will record and transmit ECG data to a gateway, which will then transmit the data to a central database."
22208|NCT02533531|O1|Outcome|1-Lead Outpatient Telemetry|"1-Lead Outpatient Patch study participants. Patients assigned to outpatient telemetry monitoring will receive the 1-Lead patch upon discharge from hospital inpatient status. ECG data will be submitted by the 1-lead patch to a central database.~1-Lead Patch: The 1-Lead Patch will record and transmit ECG data to a gateway, which will then transmit the data to a central database."
22209|NCT02533531|O1|Outcome|1-Lead Outpatient Telemetry|"1-Lead Outpatient Patch study participants. Patients assigned to outpatient telemetry monitoring will receive the 1-Lead patch upon discharge from hospital inpatient status. ECG data will be submitted by the 1-lead patch to a central database.~1-Lead Patch: The 1-Lead Patch will record and transmit ECG data to a gateway, which will then transmit the data to a central database."
22210|NCT02533531|E1|Reported Event|1-Lead Outpatient Telemetry|"1-Lead Outpatient Patch study participants. Patients assigned to outpatient telemetry monitoring will receive the 1-Lead patch upon discharge from hospital inpatient status. ECG data will be submitted by the 1-lead patch to a central database.~1-Lead Patch: The 1-Lead Patch will record and transmit ECG data to a gateway, which will then transmit the data to a central database."
22211|NCT02533466|B3|Baseline|Total|Total of all reporting groups
22212|NCT02533466|B2|Baseline|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water
22213|NCT02533466|B1|Baseline|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush and swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
22214|NCT02533466|P2|Participant Flow|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
22215|NCT02533466|P1|Participant Flow|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
22216|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water
22217|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water
22218|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water
22270|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
22271|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
22219|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water
22220|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
22221|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
22222|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
22223|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
22224|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
22225|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
22226|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
22227|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
22228|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
22229|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
22230|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
22231|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
22232|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
22233|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
22234|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
22235|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
22236|NCT02533466|E2|Reported Event|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
22237|NCT02533466|E1|Reported Event|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
22238|NCT02533401|B1|Baseline|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
22239|NCT02533401|P1|Participant Flow|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via intravenous (IV) infusion as 375 milligrams per meter-squared (mg/m^2) on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
22272|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
36443|NCT02389088|O1|Outcome|Phase I - Week 0 - 24 Hours|
22240|NCT02533401|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
22241|NCT02533401|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
22242|NCT02533401|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
22243|NCT02533401|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
22244|NCT02533401|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
22245|NCT02533401|E1|Reported Event|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
22246|NCT02533258|B1|Baseline|Axitinib (INLYTA)|Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months.
22247|NCT02533258|P1|Participant Flow|Axitinib (INLYTA)|Participants diagnosed with advanced renal cell carcinoma (RCC) and received axitinib therapy as per routine clinical practice according to the label-packaging-dosing (LPD) under the physician's prescription were observed for 40 months.
22248|NCT02533258|O1|Outcome|Axitinib (INLYTA)|Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months.
22249|NCT02533258|O1|Outcome|Axitinib (INLYTA)|Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months.
22250|NCT02533258|O1|Outcome|Axitinib (INLYTA)|Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months.
22251|NCT02533258|O1|Outcome|Axitinib (INLYTA)|Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months.
22252|NCT02533258|O1|Outcome|Axitinib (INLYTA)|Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months.
22253|NCT02533258|O1|Outcome|Axitinib (INLYTA)|Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months.
22254|NCT02533258|O1|Outcome|Axitinib (INLYTA)|Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months.
22255|NCT02533258|O1|Outcome|Axitinib (INLYTA)|Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months.
22256|NCT02533258|O1|Outcome|Axitinib (INLYTA)|Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months.
22257|NCT02533258|E1|Reported Event|Axitinib (INLYTA)|Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months.
22258|NCT02532998|B1|Baseline|All Particpants|Twenty three healthy male participants aged 18 to 50 years who satisfied all the study inclusion criteria were included in the study
22259|NCT02532998|P1|Participant Flow|All Particpants|Twenty three healthy male participants aged 18 to 50 years who satisfied all the study inclusion criteria were included in the study
22260|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
22261|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
22262|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
22263|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
22264|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
22265|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
22266|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
22267|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
22268|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
22269|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
36444|NCT02389088|O10|Outcome|Phase II - Week 6 - 24 Hours|
22284|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
22285|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
22286|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
22287|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
22288|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
22289|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
22290|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
22291|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
22292|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
22293|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
22294|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
22295|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
22296|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
22297|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
22298|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
22299|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
22300|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
22301|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
22302|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
22303|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
22304|NCT02532998|O2|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
22305|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
22306|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
22307|NCT02532998|O1|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
22308|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
22309|NCT02532998|O1|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
22310|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
22311|NCT02532998|O1|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
22312|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
22313|NCT02532998|O1|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
22314|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
22315|NCT02532998|O1|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
22316|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
22317|NCT02532998|O1|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
22318|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
22319|NCT02532998|O1|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
22320|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
22321|NCT02532998|O1|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
22322|NCT02532998|O2|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
22323|NCT02532998|O1|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
22324|NCT02532998|O2|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
22325|NCT02532998|O1|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
22326|NCT02532998|O2|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
22327|NCT02532998|O1|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
22328|NCT02532998|O2|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
22329|NCT02532998|O1|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
22330|NCT02532998|O2|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
22331|NCT02532998|O1|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
22332|NCT02532998|O2|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
22333|NCT02532998|O1|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
22334|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
22335|NCT02532998|O1|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
22336|NCT02532998|E4|Reported Event|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
22337|NCT02532998|E3|Reported Event|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
22338|NCT02532998|E2|Reported Event|Treatment B|Participants received fludrocortisone + AZD9977
22339|NCT02532998|E1|Reported Event|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
22340|NCT02532374|B1|Baseline|Nicorette® Inhalator Then P3L|"Each subject will use the Nicorette® inhalator (15 mg) on Visit 3, and then use the P3L aerosol at nicotine dose levels of approximately 50 µg/puff, 80 µg/puff and 150 µg/puff on Visits 4, 5 and 6, respectively.~Nicorette® inhalator: Subjects will inhale the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).~P3L: Subjects will inhale P3L (50 µg/puff, 80 µg/puff and 150 µg/puff) at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total)."
22685|NCT02531373|O4|Outcome|Infants: V114 High Dose + ACP|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1
22341|NCT02532374|P1|Participant Flow|Nicorette® Inhalator Then P3L|"Each subject will use the Nicorette® inhalator (15 mg) on Visit 3, and then use the P3L aerosol at nicotine dose levels of approximately 50 µg/puff, 80 µg/puff and 150 µg/puff on Visits 4, 5 and 6, respectively.~Nicorette® inhalator: Subjects will inhale the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).~P3L: Subjects will inhale P3L (50 µg/puff, 80 µg/puff and 150 µg/puff) at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total)."
22342|NCT02532374|O1|Outcome|P3L 150 µg/Puff|Subjects inhaled P3L 150 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
22343|NCT02532374|O1|Outcome|P3L 80 µg/Puff|Subjects inhaled P3L 80 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
22344|NCT02532374|O1|Outcome|P3L 50 µg/Puff|Subjects inhaled P3L 50 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
22345|NCT02532374|O1|Outcome|Nicorette® Inhalator|Subjects will inhale the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).
22346|NCT02532374|O1|Outcome|P3L 150 µg/Puff|Subjects inhaled P3L 150 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
22347|NCT02532374|O1|Outcome|P3L 80 µg/Puff|Subjects inhaled P3L 80 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
22348|NCT02532374|O1|Outcome|P3L 50 µg/Puff|Subjects inhaled P3L 50 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
22349|NCT02532374|O1|Outcome|Nicorette® Inhalator|Subjects will inhale the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).
22350|NCT02532374|O1|Outcome|P3L 150 µg/Puff|Subjects inhaled P3L 150 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
22351|NCT02532374|O1|Outcome|P3L 80 µg/Puff|Subjects inhaled P3L 80 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
22352|NCT02532374|O1|Outcome|P3L 50 µg/Puff|Subjects inhaled P3L 50 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
22353|NCT02532374|O1|Outcome|Nicorette® Inhalator|Subjects will inhale the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).
22354|NCT02532374|O1|Outcome|P3L 150 µg/Puff|Subjects inhaled P3L 150 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
22355|NCT02532374|O1|Outcome|P3L 80 µg/Puff|Subjects inhaled P3L 80 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
22356|NCT02532374|O1|Outcome|P3L 50 µg/Puff|Subjects inhaled P3L 50 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
22357|NCT02532374|O1|Outcome|Nicorette® Inhalator|Subjects will inhale the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).
22358|NCT02532374|E6|Reported Event|Safety Follow-up Period|All subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator entered a 7-day safety follow-up period during which (serious) adverse events can be spontaneously reported by the subjects.
22359|NCT02532374|E5|Reported Event|P3L 150 µg/Puff Period|Subjects inhaled P3L 150 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
22360|NCT02532374|E4|Reported Event|P3L 80 µg/Puff Period|Subjects inhaled P3L 80 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
22361|NCT02532374|E3|Reported Event|P3L 50 µg/Puff Period|Subjects inhaled P3L 50 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
22362|NCT02532374|E2|Reported Event|Nicorette® Inhalator Period|Subjects inhaled the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).
22363|NCT02532374|E1|Reported Event|Enrolment Period|"All subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator.~Product test period - from enrolment to admission."
22364|NCT02532179|B1|Baseline|Mouse Allergenic Extract|Participants received escalating doses of glycerinated mouse allergenic extract administered via the subcutaneous route. The first injection contained 0.05 mL of 1:10,000 concentration of 1:20 weight per volume (w/v) glycerinated mouse allergenic extract. Administration of additional dosages were given at study clinician’s discretion, up to a Maximum Study Dose (MSD) of 0.4 mL of extract at a concentration of 1:10 w/v, for the first 11 weeks of the 24-week treatment with two injections per week, separated by at least 2 days. Dose escalation continued until maximum study dose was achieved in a maximum of 18 weeks. For the remaining time of the 24-week treatment, participants received one injection of investigational agent every 2 weeks and were asked to report any symptoms possibly related to the investigation agent to the study sites.
22365|NCT02532179|P1|Participant Flow|Mouse Allergenic Extract|Participants received escalating doses of glycerinated mouse allergenic extract administered via the subcutaneous route. The first injection contained 0.05 mL of 1:10,000 concentration of 1:20 weight per volume (w/v) glycerinated mouse allergenic extract. Administration of additional dosages were given at study clinician’s discretion, up to a Maximum Study Dose (MSD) of 0.4 mL of extract at a concentration of 1:10 w/v, for the first 11 weeks of the 24-week treatment with two injections per week, separated by at least 2 days. Dose escalation continued until maximum study dose was achieved in a maximum of 18 weeks. For the remaining time of the 24-week treatment, participants received one injection of investigational agent every 2 weeks and were asked to report any symptoms possibly related to the investigation agent to the study sites.
36445|NCT02389088|O9|Outcome|Phase II - Week 6 - 0 Hours|
22366|NCT02532179|O1|Outcome|Mouse Allergenic Extract|Participants received escalating doses of glycerinated mouse allergenic extract administered via the subcutaneous route. The first injection contained 0.05 mL of 1:10,000 concentration of 1:20 weight per volume (w/v) glycerinated mouse allergenic extract. Administration of additional dosages were given at study clinician’s discretion, up to a Maximum Study Dose (MSD) of 0.4 mL of extract at a concentration of 1:10 w/v, for the first 11 weeks of the 24-week treatment with two injections per week, separated by at least 2 days. Dose escalation continued until maximum study dose was achieved in a maximum of 18 weeks. For the remaining time of the 24-week treatment, participants received one injection of investigational agent every 2 weeks and were asked to report any symptoms possibly related to the investigation agent to the study sites.
22367|NCT02532179|O1|Outcome|Mouse Allergenic Extract|Participants received escalating doses of glycerinated mouse allergenic extract administered via the subcutaneous route. The first injection contained 0.05 mL of 1:10,000 concentration of 1:20 weight per volume (w/v) glycerinated mouse allergenic extract. Administration of additional dosages were given at study clinician’s discretion, up to a Maximum Study Dose (MSD) of 0.4 mL of extract at a concentration of 1:10 w/v, for the first 11 weeks of the 24-week treatment with two injections per week, separated by at least 2 days. Dose escalation continued until maximum study dose was achieved in a maximum of 18 weeks. For the remaining time of the 24-week treatment, participants received one injection of investigational agent every 2 weeks and were asked to report any symptoms possibly related to the investigation agent to the study sites.
22368|NCT02532179|O1|Outcome|Mouse Allergenic Extract|Participants received escalating doses of glycerinated mouse allergenic extract administered via the subcutaneous route. The first injection contained 0.05 mL of 1:10,000 concentration of 1:20 weight per volume (w/v) glycerinated mouse allergenic extract. Administration of additional dosages were given at study clinician’s discretion, up to a Maximum Study Dose (MSD) of 0.4 mL of extract at a concentration of 1:10 w/v, for the first 11 weeks of the 24-week treatment with two injections per week, separated by at least 2 days. Dose escalation continued until maximum study dose was achieved in a maximum of 18 weeks. For the remaining time of the 24-week treatment, participants received one injection of investigational agent every 2 weeks and were asked to report any symptoms possibly related to the investigation agent to the study sites.
22369|NCT02532179|O1|Outcome|Mouse Allergenic Extract|Participants received escalating doses of glycerinated mouse allergenic extract administered via the subcutaneous route. The first injection contained 0.05 mL of 1:10,000 concentration of 1:20 weight per volume (w/v) glycerinated mouse allergenic extract. Administration of additional dosages were given at study clinician’s discretion, up to a Maximum Study Dose (MSD) of 0.4 mL of extract at a concentration of 1:10 w/v, for the first 11 weeks of the 24-week treatment with two injections per week, separated by at least 2 days. Dose escalation continued until maximum study dose was achieved in a maximum of 18 weeks. For the remaining time of the 24-week treatment, participants received one injection of investigational agent every 2 weeks and were asked to report any symptoms possibly related to the investigation agent to the study sites.
22370|NCT02532179|O1|Outcome|Mouse Allergenic Extract|Participants received escalating doses of glycerinated mouse allergenic extract administered via the subcutaneous route. The first injection contained 0.05 mL of 1:10,000 concentration of 1:20 weight per volume (w/v) glycerinated mouse allergenic extract. Administration of additional dosages were given at study clinician’s discretion, up to a Maximum Study Dose (MSD) of 0.4 mL of extract at a concentration of 1:10 w/v, for the first 11 weeks of the 24-week treatment with two injections per week, separated by at least 2 days. Dose escalation continued until maximum study dose was achieved in a maximum of 18 weeks. For the remaining time of the 24-week treatment, participants received one injection of investigational agent every 2 weeks and were asked to report any symptoms possibly related to the investigation agent to the study sites.
22371|NCT02532179|O1|Outcome|Mouse Allergenic Extract|Participants received escalating doses of glycerinated mouse allergenic extract administered via the subcutaneous route. The first injection contained 0.05 mL of 1:10,000 concentration of 1:20 weight per volume (w/v) glycerinated mouse allergenic extract. Administration of additional dosages were given at study clinician’s discretion, up to a Maximum Study Dose (MSD) of 0.4 mL of extract at a concentration of 1:10 w/v, for the first 11 weeks of the 24-week treatment with two injections per week, separated by at least 2 days. Dose escalation continued until maximum study dose was achieved in a maximum of 18 weeks. For the remaining time of the 24-week treatment, participants received one injection of investigational agent every 2 weeks and were asked to report any symptoms possibly related to the investigation agent to the study sites.
22372|NCT02532179|E1|Reported Event|Mouse Allergenic Extract|Participants received escalating doses of glycerinated mouse allergenic extract administered via the subcutaneous route. The first injection contained 0.05 mL of 1:10,000 concentration of 1:20 w/v glycerinated mouse allergenic extract, with proceeding administration of additional dosage at study clinician’s discretion, for up to a Maximum Study Dose (MSD) of 0.4 mL of extract at a concentration of 1:10 wt/vol for the first 11 weeks of the 24-week treatment with two injections per week, separated by at least 2 days. Dose escalation would continue until maximum study dose is achieved in a maximum of 18 weeks. For the remaining time of the 24-week treatment, participants would receive one injection of investigational agent every 2 weeks and were asked to report any symptoms possibly related to the investigation agent to the study sites.
22373|NCT02531867|B1|Baseline|Overall Study|Patients enrolled in this study received a total of 6 mg/kg/week asfotase alfa by SC injection. At the Investigator’s discretion, patients were continued on the dose established in the Investigator-initiated studies, receiving either 1 mg/kg asfotase alfa 6 times per week or 2 mg/kg asfotase alfa 3 times per week.
22374|NCT02531867|P1|Participant Flow|Overall Study|Patients enrolled in this study received a total of 6 mg/kg/week asfotase alfa by SC injection. At the Investigator’s discretion, patients were continued on the dose established in the Investigator-initiated studies, receiving either 1 mg/kg asfotase alfa 6 times per week or 2 mg/kg asfotase alfa 3 times per week.
22375|NCT02531867|O1|Outcome|Overall Study|Patients enrolled in this study received a total of 6 mg/kg/week asfotase alfa by SC injection. At the Investigator’s discretion, patients were continued on the dose established in the Investigator-initiated studies, receiving either 1 mg/kg asfotase alfa 6 times per week or 2 mg/kg asfotase alfa 3 times per week.
22376|NCT02531867|E1|Reported Event|Overall Study|Patients enrolled in this study received a total of 6 mg/kg/week asfotase alfa by SC injection. At the Investigator’s discretion, patients were continued on the dose established in the Investigator-initiated studies, receiving either 1 mg/kg asfotase alfa 6 times per week or 2 mg/kg asfotase alfa 3 times per week.
22378|NCT02531698|B2|Baseline|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22379|NCT02531698|B1|Baseline|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22380|NCT02531698|P2|Participant Flow|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22381|NCT02531698|P1|Participant Flow|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from greater than or equal to (>=) 24 months to less than (<) 10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22382|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22383|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22384|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22385|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22386|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22387|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22388|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22389|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22390|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22391|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22392|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22393|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22394|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22395|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22396|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22397|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22398|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22399|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22400|NCT02531698|O2|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22401|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22402|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22403|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22404|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22405|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22406|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22407|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22408|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22409|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22410|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22411|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22412|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22413|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22414|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22415|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22416|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22417|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22418|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22419|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22420|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22421|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22422|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22423|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22424|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22425|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22426|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22427|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22428|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22429|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22430|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22431|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22432|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22433|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22434|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22435|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22436|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22437|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22438|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22439|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22440|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22441|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
36446|NCT02389088|O8|Outcome|Phase II - Week 5 - 24 Hours|
22442|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22443|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22444|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22445|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22446|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22447|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22448|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22449|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22450|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22451|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22452|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22453|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22454|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22455|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22456|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22457|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22458|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22459|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22460|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22461|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22462|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22463|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22464|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22465|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22466|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22467|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22468|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22469|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22470|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22471|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22472|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22473|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
36447|NCT02389088|O7|Outcome|Phase II - Week 5 - 0 Hours|
22474|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22475|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22476|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22477|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22478|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22479|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22480|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22481|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22482|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22483|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22484|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22485|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22486|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22487|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22488|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22489|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22490|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22491|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22492|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22493|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22494|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22495|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22496|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22497|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22498|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22499|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22500|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22501|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22502|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22503|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22504|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22505|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
36448|NCT02389088|O6|Outcome|Phase II - Week 0 - 24 Hours|
22506|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22507|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22508|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22509|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22510|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22511|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22512|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22513|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22514|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22515|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22516|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22517|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22518|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22519|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22520|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22521|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22522|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22523|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22524|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22525|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22526|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22527|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22528|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22529|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22530|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22531|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22532|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22533|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22534|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22535|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22536|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22537|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
36449|NCT02389088|O5|Outcome|Phase I - Week 6 - 24 Hour|
22538|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22539|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22540|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22541|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22542|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22543|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22544|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22545|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22546|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22547|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22548|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22549|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22550|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22551|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22552|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22553|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22554|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22555|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22556|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22557|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22558|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22559|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22560|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22561|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22562|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22563|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22564|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22565|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22566|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22567|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22568|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22569|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
36450|NCT02389088|O4|Outcome|Phase I - Week 6 - 0 Hour|
22570|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22571|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22572|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22573|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22574|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22575|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22576|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22577|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22578|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22579|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22580|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22581|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22582|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22583|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22584|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22585|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22586|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22587|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22588|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22589|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22590|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22591|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22592|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22593|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22594|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22595|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22596|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22597|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22598|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22599|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22600|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22601|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
36451|NCT02389088|O3|Outcome|Phase I - Week 5 - 24 Hour|
22602|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22603|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22604|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22605|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22606|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22607|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22608|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22609|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22610|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22611|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22612|NCT02531698|O6|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22613|NCT02531698|O5|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22614|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22615|NCT02531698|O3|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22616|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22617|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22618|NCT02531698|O4|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22619|NCT02531698|O3|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
22620|NCT02531698|O2|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22621|NCT02531698|O1|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22622|NCT02531698|E2|Reported Event|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule
22623|NCT02531698|E1|Reported Event|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
22624|NCT02531646|B4|Baseline|Total|Total of all reporting groups
22625|NCT02531646|B3|Baseline|Predicate & Invest. DT - Phantom Images|"Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
22626|NCT02531646|B2|Baseline|Predicate & Invest. DT – Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
22627|NCT02531646|B1|Baseline|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
22628|NCT02531646|P3|Participant Flow|Predicate & Invest. DT - Phantom Images|"Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
22644|NCT02531373|B9|Baseline|Infants: Prevnar 13™|Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
22645|NCT02531373|B8|Baseline|Infants: V114 High Dose + ACP|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP at 2, 4, 6, and 12-15 months of age
22629|NCT02531646|P2|Participant Flow|Predicate & Invest. DT – Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
22630|NCT02531646|P1|Participant Flow|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
22631|NCT02531646|O1|Outcome|Predicate & Invest. DT - Phantom Images|"Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
22632|NCT02531646|O1|Outcome|Predicate & Invest. DT - Phantom Images|"Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
22633|NCT02531646|O1|Outcome|Predicate & Invest. DT – Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
22634|NCT02531646|O1|Outcome|Predicate & Invest. DT – Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
22635|NCT02531646|O1|Outcome|Predicate & Invest. DT – Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
22636|NCT02531646|O1|Outcome|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
22637|NCT02531646|O1|Outcome|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
22638|NCT02531646|O1|Outcome|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
22639|NCT02531646|O1|Outcome|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
22640|NCT02531646|E3|Reported Event|Predicate & Invest. DT - Phantom Images|"Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
22641|NCT02531646|E2|Reported Event|Predicate & Invest. DT – Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
22642|NCT02531646|E1|Reported Event|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
22646|NCT02531373|B7|Baseline|Infants: V114 Medium Dose + ACP|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 with ACP at 2, 4, 6, and 12-15 months of age
22647|NCT02531373|B6|Baseline|Infants: V114 High Dose|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
22648|NCT02531373|B5|Baseline|Infants: V114 Medium Dose|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
22649|NCT02531373|B4|Baseline|Adults: V114 High Dose + ACP|Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1
22650|NCT02531373|B3|Baseline|Adults: V114 Medium Dose + ACP|Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1
22651|NCT02531373|B2|Baseline|Adults: V114 High Dose|Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1
22652|NCT02531373|B1|Baseline|Adults: V114 Medium Dose|Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1
22653|NCT02531373|P9|Participant Flow|Infants: Prevnar 13™|Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
22654|NCT02531373|P8|Participant Flow|Infants: V114 High Dose + ACP|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP at 2, 4, 6, and 12-15 months of age
22655|NCT02531373|P7|Participant Flow|Infants: V114 Medium Dose + ACP|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 with ACP at 2, 4, 6, and 12-15 months of age
22656|NCT02531373|P6|Participant Flow|Infants: V114 High Dose|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
22657|NCT02531373|P5|Participant Flow|Infants: V114 Medium Dose|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
22658|NCT02531373|P4|Participant Flow|Adults: V114 High Dose + ACP|Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1
22659|NCT02531373|P3|Participant Flow|Adults: V114 Medium Dose + ACP|Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1
22660|NCT02531373|P2|Participant Flow|Adults: V114 High Dose|Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1
22661|NCT02531373|P1|Participant Flow|Adults: V114 Medium Dose|Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1
22662|NCT02531373|O3|Outcome|Infants: Prevnar 13™|Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
22663|NCT02531373|O2|Outcome|Infants: V114 High Dose|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
22664|NCT02531373|O1|Outcome|Infants: V114 Medium Dose|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
22665|NCT02531373|O3|Outcome|Infants: Prevnar 13™|Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
22666|NCT02531373|O2|Outcome|Infants: V114 High Dose|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
22667|NCT02531373|O1|Outcome|Infants: V114 Medium Dose|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
22668|NCT02531373|O3|Outcome|Infants: Prevnar 13™|Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
22669|NCT02531373|O2|Outcome|Infants: V114 High Dose|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
22670|NCT02531373|O1|Outcome|Infants: V114 Medium Dose|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
22671|NCT02531373|O3|Outcome|Infants: Prevnar 13™|Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
22672|NCT02531373|O2|Outcome|Infants: V114 High Dose|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
22673|NCT02531373|O1|Outcome|Infants: V114 Medium Dose|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
22674|NCT02531373|O3|Outcome|Infants: Prevnar 13™|Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
22675|NCT02531373|O2|Outcome|Infants: V114 High Dose|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
22676|NCT02531373|O1|Outcome|Infants: V114 Medium Dose|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
22677|NCT02531373|O2|Outcome|Adults: V114 High Dose|Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1
22678|NCT02531373|O1|Outcome|Adults: V114 Medium Dose|Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1
22679|NCT02531373|O2|Outcome|Adults: V114 High Dose|Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1
22680|NCT02531373|O1|Outcome|Adults: V114 Medium Dose|Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1
22681|NCT02531373|O3|Outcome|Infants: Prevnar 13™|Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
22682|NCT02531373|O2|Outcome|Infants: V114 High Dose|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
22683|NCT02531373|O1|Outcome|Infants: V114 Medium Dose|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
22684|NCT02531373|O5|Outcome|Infants: Prevnar 13™|Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
22796|NCT02529995|E2|Reported Event|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
22686|NCT02531373|O3|Outcome|Infants: V114 Medium Dose + ACP|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1
22687|NCT02531373|O2|Outcome|Infants: V114 High Dose|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
22688|NCT02531373|O1|Outcome|Infants: V114 Medium Dose|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
22689|NCT02531373|O5|Outcome|Infants: Prevnar 13™|Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
22690|NCT02531373|O4|Outcome|Infants: V114 High Dose + ACP|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1
22691|NCT02531373|O3|Outcome|Infants: V114 Medium Dose + ACP|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1
22692|NCT02531373|O2|Outcome|Infants: V114 High Dose|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
22693|NCT02531373|O1|Outcome|Infants: V114 Medium Dose|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
22694|NCT02531373|O5|Outcome|Infants: Prevnar 13™|Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
22695|NCT02531373|O4|Outcome|Infants: V114 High Dose + ACP|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1
22696|NCT02531373|O3|Outcome|Infants: V114 Medium Dose + ACP|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1
22697|NCT02531373|O2|Outcome|Infants: V114 High Dose|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
22698|NCT02531373|O1|Outcome|Infants: V114 Medium Dose|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
22699|NCT02531373|O5|Outcome|Infants: Prevnar 13™|Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
22700|NCT02531373|O4|Outcome|Infants: V114 High Dose + ACP|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1
22701|NCT02531373|O3|Outcome|Infants: V114 Medium Dose + ACP|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1
22702|NCT02531373|O2|Outcome|Infants: V114 High Dose|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
22703|NCT02531373|O1|Outcome|Infants: V114 Medium Dose|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
22704|NCT02531373|O4|Outcome|Adults: V114 High Dose + ACP|Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1
22705|NCT02531373|O3|Outcome|Adults: V114 Medium Dose + ACP|Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1
22706|NCT02531373|O2|Outcome|Adults: V114 High Dose|Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1
22707|NCT02531373|O1|Outcome|Adults: V114 Medium Dose|Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1
22708|NCT02531373|E9|Reported Event|Prevnar 13 Infants|Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
22709|NCT02531373|E8|Reported Event|V114 High + ACP Infants|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP at 2, 4, 6, and 12-15 months of age
22710|NCT02531373|E7|Reported Event|V114 Medium + ACP Infants|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 with ACP at 2, 4, 6, and 12-15 months of age
22711|NCT02531373|E6|Reported Event|V114 High Infants|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
22712|NCT02531373|E5|Reported Event|V114 Medium Infants|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
22713|NCT02531373|E4|Reported Event|V114 High + ACP Adults|Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1
22714|NCT02531373|E3|Reported Event|V114 Medium + ACP Adults|Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1
22715|NCT02531373|E2|Reported Event|V114 High Adults|Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1
22716|NCT02531373|E1|Reported Event|V114 Medium Adults|Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1
22717|NCT02531308|B1|Baseline|R-CHOP With Metformin|"Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study.~Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study."
22718|NCT02531308|P1|Participant Flow|R-CHOP With Metformin|"Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study.~Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study.~Metformin: Metformin upregulates AMPK activity which has been shown to have an anti-proliferative effect on lymphoma cells.~Rituximab: monoclonal antibody against protein CD20~Cyclophosphamide: Interferes with DNA replication~Doxorubicin: anthracycline antitumor antibiotic~Vincristine: Inhibits cell mitosis causing cell death.~Prednisone: a synthetic cortic"
22719|NCT02531308|O1|Outcome|R-CHOP With Metformin|"Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study.~Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study."
22720|NCT02531308|E1|Reported Event|R-CHOP With Metformin|"Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study.~Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study.~Metformin: Metformin upregulates AMPK activity which has been shown to have an anti-proliferative effect on lymphoma cells.~Rituximab: monoclonal antibody against protein CD20~Cyclophosphamide: Interferes with DNA replication~Doxorubicin: anthracycline antitumor antibiotic~Vincristine: Inhibits cell mitosis causing cell death.~Prednisone: a synthetic cortic"
22721|NCT02530671|B3|Baseline|Total|Total of all reporting groups
22722|NCT02530671|B2|Baseline|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
22723|NCT02530671|B1|Baseline|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
22724|NCT02530671|P2|Participant Flow|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
22725|NCT02530671|P1|Participant Flow|Manual Toothbrush|"ADA (American Dental Association) reference manual toothbrush~Toothbrushing with manual toothbrush"
22726|NCT02530671|O2|Outcome|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
22727|NCT02530671|O1|Outcome|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
22728|NCT02530671|O2|Outcome|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
22729|NCT02530671|O1|Outcome|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
22730|NCT02530671|O2|Outcome|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
22731|NCT02530671|O1|Outcome|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
22732|NCT02530671|O2|Outcome|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
22733|NCT02530671|O1|Outcome|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
22734|NCT02530671|O2|Outcome|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
22735|NCT02530671|O1|Outcome|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
22736|NCT02530671|O2|Outcome|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
22737|NCT02530671|O1|Outcome|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
22738|NCT02530671|E2|Reported Event|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
22739|NCT02530671|E1|Reported Event|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
22740|NCT02530450|B3|Baseline|Total|Total of all reporting groups
22741|NCT02530450|B2|Baseline|Group 2|"Never blinded to continuous glucose monitoring data~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
22742|NCT02530450|B1|Baseline|Group 1|"Initially blinded to continuous glucose monitoring data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
22743|NCT02530450|P2|Participant Flow|Group 2|Never blinded to continuous glucose monitoring data
22744|NCT02530450|P1|Participant Flow|Group 1|Initially blinded to continuous glucose monitoring data
22745|NCT02530450|O2|Outcome|Group 2|"Never blinded to continuous glucose monitoring data~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
22746|NCT02530450|O1|Outcome|Group 1|"Initially blinded to continuous glucose monitoring data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
22747|NCT02530450|E2|Reported Event|Group 2|"Never blinded to continuous glucose monitoring data~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
22748|NCT02530450|E1|Reported Event|Group 1|"Initially blinded to continuous glucose monitoring data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
22749|NCT02530125|B1|Baseline|Treatment (Pidilizumab)|"Patients receive pidilizumab IV over approximately 5 hours on day 1. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pidilizumab: Given IV"
22797|NCT02529995|E1|Reported Event|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
22798|NCT02529488|B1|Baseline|TFNT00|AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
22750|NCT02530125|P1|Participant Flow|Treatment (Pidilizumab)|"Patients receive pidilizumab IV over approximately 5 hours on day 1. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pidilizumab: Given IV"
22751|NCT02530125|O1|Outcome|Treatment (Pidilizumab)|"Patients receive pidilizumab IV over approximately 5 hours on day 1. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pidilizumab: Given IV"
22752|NCT02530125|O1|Outcome|Treatment (Pidilizumab)|"Patients receive pidilizumab IV over approximately 5 hours on day 1. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pidilizumab: Given IV"
22753|NCT02530125|O1|Outcome|Treatment (Pidilizumab)|"Patients receive pidilizumab IV over approximately 5 hours on day 1. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pidilizumab: Given IV"
22754|NCT02530125|O1|Outcome|Treatment (Pidilizumab)|"Patients receive pidilizumab IV over approximately 5 hours on day 1. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pidilizumab: Given IV"
22755|NCT02530125|O1|Outcome|Treatment (Pidilizumab)|"Patients receive pidilizumab IV over approximately 5 hours on day 1. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pidilizumab: Given IV"
22756|NCT02530125|O1|Outcome|Treatment (Pidilizumab)|"Patients receive pidilizumab IV over approximately 5 hours on day 1. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pidilizumab: Given IV"
22757|NCT02530125|O1|Outcome|Treatment (Pidilizumab)|"Patients receive pidilizumab IV over approximately 5 hours on day 1. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pidilizumab: Given IV"
22758|NCT02530125|O1|Outcome|Treatment (Pidilizumab)|"Patients receive pidilizumab IV over approximately 5 hours on day 1. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pidilizumab: Given IV"
22759|NCT02530125|O1|Outcome|Treatment (Pidilizumab)|"Patients receive pidilizumab IV over approximately 5 hours on day 1. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pidilizumab: Given IV"
22760|NCT02530125|E1|Reported Event|Treatment (Pidilizumab)|"Patients receive pidilizumab IV over approximately 5 hours on day 1. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pidilizumab: Given IV"
22761|NCT02529995|B3|Baseline|Total|Total of all reporting groups
22762|NCT02529995|B2|Baseline|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
22763|NCT02529995|B1|Baseline|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
22764|NCT02529995|P2|Participant Flow|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
22765|NCT02529995|P1|Participant Flow|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
22766|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
22767|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
22768|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
22769|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
22770|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
22771|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
22772|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
22773|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
22774|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
22775|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
22776|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
22777|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
22778|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
22779|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
22780|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
22781|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
22782|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
22783|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
22784|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
22785|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
22786|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
22787|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
22788|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
22789|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
22790|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
22791|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
22792|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
22793|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
22794|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
22795|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
22799|NCT02529488|P1|Participant Flow|TFNT00|AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
22800|NCT02529488|O2|Outcome|TFNT00 Visit 4A|AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation at Day 120-180 post second eye implantation
22801|NCT02529488|O1|Outcome|TFNT00 Visit 3A|AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation at Day 20-40 post second eye implantation
22802|NCT02529488|E4|Reported Event|TFNT00 - Systemic|All subjects with attempted test article implantation (successful or aborted after contact with the eye).
22803|NCT02529488|E3|Reported Event|TFNT00 - Non-Study Eye|All eyes not implanted with a study lens
22804|NCT02529488|E2|Reported Event|TFNT00 - 2nd Eye|All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the 2nd implanted eye
22805|NCT02529488|E1|Reported Event|TFNT00 - 1st Eye|All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the 1st implanted eye
22806|NCT02528786|B1|Baseline|All Participants|Participants who received namilumab in the phase 1 PRIORA M1-1188-002-EM (NCT01317797) were enrolled. Two blood samples (3 mL per sample) for DNA isolation were collected from each participant.
22807|NCT02528786|P1|Participant Flow|All Participants|Participants who received namilumab in the phase 1 PRIORA M1-1188-002-EM (NCT01317797) were enrolled. Two blood samples (3 milliliter [mL] per sample) for DNA isolation were collected from each participant.
22808|NCT02528786|O1|Outcome|All Participants|Participants who received namilumab in the phase 1 PRIORA M1-1188-002-EM (NCT01317797) were enrolled. Two blood samples (3 mL per sample) for DNA isolation were collected from each participant.
22809|NCT02528786|E1|Reported Event|All Participants|Participants who received namilumab in the phase 1 PRIORA M1-1188-002-EM (NCT01317797) were enrolled. Two blood samples (3 mL per sample) for DNA isolation were collected from each participant.
22810|NCT02528721|B3|Baseline|Total|Total of all reporting groups
22811|NCT02528721|B2|Baseline|Post Therapy Subjects|"Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
22812|NCT02528721|B1|Baseline|Initial Diagnosis Subjects|"Patients with clinical indication for H.pylori infection~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
22813|NCT02528721|P2|Participant Flow|Post Therapy Subjects|"Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
22814|NCT02528721|P1|Participant Flow|Initial Diagnosis Subjects|"Patients with clinical indication for H.pylori infection~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
22815|NCT02528721|O2|Outcome|Post Therapy Subjects|"Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
22816|NCT02528721|O1|Outcome|Initial Diagnosis Subjects|"Patients with clinical indication for H.pylori infection~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
22817|NCT02528721|O2|Outcome|Post Therapy Subjects|"Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
22818|NCT02528721|O1|Outcome|Initial Diagnosis Subjects|"Patients with clinical indication for H.pylori infection~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
22819|NCT02528721|O2|Outcome|Post Therapy Subjects|"Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
22820|NCT02528721|O1|Outcome|Initial Diagnosis Subjects|"Patients with clinical indication for H.pylori infection~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
22821|NCT02528721|E2|Reported Event|Post Therapy Subjects|"Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
22822|NCT02528721|E1|Reported Event|Initial Diagnosis Subjects|"Patients with clinical indication for H.pylori infection~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
22823|NCT02528331|B1|Baseline|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation~Cognitive behavioral therapy"
22824|NCT02528331|P1|Participant Flow|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation~Cognitive behavioral therapy"
22825|NCT02528331|O1|Outcome|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation~Cognitive behavioral therapy"
22826|NCT02528331|O1|Outcome|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation~Cognitive behavioral therapy"
22827|NCT02528331|O1|Outcome|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation~Cognitive behavioral therapy"
22828|NCT02528331|O1|Outcome|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation~Cognitive behavioral therapy"
22829|NCT02528331|E1|Reported Event|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation~Cognitive behavioral therapy"
22901|NCT02527148|B2|Baseline|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
24835|NCT02498652|O6|Outcome|Treatment R3|Allopurinol 300 mg qd + RDEA3170 7.5 mg qd (Cohort 1)
22830|NCT02528305|B1|Baseline|High-intensity Interval Training (HIT)|"6 week control period with no intervention then 6 weeks of twice weekly HIT~High-intensity Interval Training: 2 minute warm-up at 50rpm, then increase to 100rpm. Weight added to bike (7% body weight for men 6% body weight for women). Continue effort for 6 seconds, then passive rest for at least 1 minute. Total 5 sprints in sessions 1-3, 6 sprints in session4, 7 sprints in sessions 5&6, 8 sprints in sessions 7&8, 9 sprints in sessions 9&10 and 10 sprints in sessions 11&12."
22831|NCT02528305|P1|Participant Flow|High-intensity Interval Training (HIT)|"6 week control period with no intervention then 6 weeks of twice weekly HIT~High-intensity Interval Training: 2 minute warm-up at 50rpm, then increase to 100rpm. Weight added to bike (7% body weight for men 6% body weight for women). Continue effort for 6 seconds, then passive rest for at least 1 minute. Total 5 sprints in sessions 1-3, 6 sprints in session4, 7 sprints in sessions 5&6, 8 sprints in sessions 7&8, 9 sprints in sessions 9&10 and 10 sprints in sessions 11&12."
22832|NCT02528305|O3|Outcome|After HIT Assessment|final assessment within 1 week of completing 6 weeks of HIT
22833|NCT02528305|O2|Outcome|After 6 Week Control Period|repeat assessment after 6 weeks of no intervention
22834|NCT02528305|O1|Outcome|Baseline Assessment|on entry to trial
22835|NCT02528305|O3|Outcome|After HIT Assessment|final assessment within 1 week of completing 6 weeks of HIT
22836|NCT02528305|O2|Outcome|After 6 Week Control Period|repeat assessment after 6 weeks of no intervention
22837|NCT02528305|O1|Outcome|Baseline Assessment|on entry to trial
22838|NCT02528305|O3|Outcome|After HIT Assessment|final assessment within 1 week of completing 6 weeks of HIT
22839|NCT02528305|O2|Outcome|After 6 Week Control Period|repeat assessment after 6 weeks of no intervention
22840|NCT02528305|O1|Outcome|Baseline Assessment|on entry to trial
22841|NCT02528305|O3|Outcome|After HIT Assessment|final assessment within 1 week of completing 6 weeks of HIT
22842|NCT02528305|O2|Outcome|After 6 Week Control Period|repeat assessment after 6 weeks of no intervention
22843|NCT02528305|O1|Outcome|Baseline Assessment|on entry to trial
22844|NCT02528305|O3|Outcome|After HIT Assessment|final assessment within 1 week of completing 6 weeks of HIT
22845|NCT02528305|O2|Outcome|After 6 Week Control Period|repeat assessment after 6 weeks of no intervention
22846|NCT02528305|O1|Outcome|Baseline Assessment|on entry to trial
22847|NCT02528305|O3|Outcome|After HIT Assessment|final assessment within 1 week of completing 6 weeks of HIT
22848|NCT02528305|O2|Outcome|After 6 Week Control Period|repeat assessment after 6 weeks of no intervention
22849|NCT02528305|O1|Outcome|Baseline Assessment|on entry to trial
22850|NCT02528305|O3|Outcome|After HIT Assessment|final assessment within 1 week of completing 6 weeks of HIT
22851|NCT02528305|O2|Outcome|After 6 Week Control Period|repeat assessment after 6 weeks of no intervention
22852|NCT02528305|O1|Outcome|Baseline Assessment|on entry to trial
22853|NCT02528305|O3|Outcome|After HIT Assessment|final assessment within 1 week of completing 6 weeks of HIT
22854|NCT02528305|O2|Outcome|After 6 Week Control Period|repeat assessment after 6 weeks of no intervention
22855|NCT02528305|O1|Outcome|Baseline Assessment|on entry to trial
22856|NCT02528305|O3|Outcome|After HIT Assessment|final assessment within 1 week of completing 6 weeks of HIT
22857|NCT02528305|O2|Outcome|After 6 Week Control Period|repeat assessment after 6 weeks of no intervention
22858|NCT02528305|O1|Outcome|Baseline Assessment|on entry to trial
22859|NCT02528305|O3|Outcome|After HIT Assessment|final assessment within 1 week of completing 6 weeks of HIT
22860|NCT02528305|O2|Outcome|After 6 Week Control Period|repeat assessment after 6 weeks of no intervention
22861|NCT02528305|O1|Outcome|Baseline Assessment|on entry to trial
22862|NCT02528305|O3|Outcome|After HIT Assessment|final assessment within 1 week of completing 6 weeks of HIT
22863|NCT02528305|O2|Outcome|After 6 Week Control Period|repeat assessment after 6 weeks of no intervention
22864|NCT02528305|O1|Outcome|Baseline Assessment|on entry to trial
22865|NCT02528305|O3|Outcome|After HIT Assessment|final assessment within 1 week of completing 6 weeks of HIT
22866|NCT02528305|O2|Outcome|After 6 Week Control Period|repeat assessment after 6 weeks of no intervention
22867|NCT02528305|O1|Outcome|Baseline Assessment|on entry to trial
22868|NCT02528305|O3|Outcome|After HIT Assessment|final assessment within 1 week of completing 6 weeks of HIT
22869|NCT02528305|O2|Outcome|After 6 Week Control Period|repeat assessment after 6 weeks of no intervention
22870|NCT02528305|O1|Outcome|Baseline Assessment|on entry to trial
22871|NCT02528305|E1|Reported Event|High-intensity Interval Training (HIT)|"6 week control period with no intervention then 6 weeks of twice weekly HIT~High-intensity Interval Training: 2 minute warm-up at 50rpm, then increase to 100rpm. Weight added to bike (7% body weight for men 6% body weight for women). Continue effort for 6 seconds, then passive rest for at least 1 minute. Total 5 sprints in sessions 1-3, 6 sprints in session4, 7 sprints in sessions 5&6, 8 sprints in sessions 7&8, 9 sprints in sessions 9&10 and 10 sprints in sessions 11&12."
22872|NCT02528097|B3|Baseline|Total|Total of all reporting groups
22873|NCT02528097|B2|Baseline|Experimental|"Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline.~Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)"
22874|NCT02528097|B1|Baseline|Active Comparator Standard Care|"albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)~Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)"
22902|NCT02527148|B1|Baseline|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
23484|NCT02514473|O1|Outcome|Placebo|Participants received placebo matched to LUM in combination with IVA FDC tablets orally q12h for 24 weeks.
22875|NCT02528097|P2|Participant Flow|Experimental|"Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline.~Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)"
22876|NCT02528097|P1|Participant Flow|Active Comparator Standard Care|"albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)~Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)"
22877|NCT02528097|O2|Outcome|Experimental|"Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline.~Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)"
22878|NCT02528097|O1|Outcome|Active Comparator Standard Care|"albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)~Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)"
22879|NCT02528097|O2|Outcome|Experimental|"Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline.~Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)"
22880|NCT02528097|O1|Outcome|Active Comparator Standard Care|"albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)~Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)"
22881|NCT02528097|E2|Reported Event|Experimental|"Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline.~Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)"
22882|NCT02528097|E1|Reported Event|Active Comparator Standard Care|"albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)~Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)"
22883|NCT02527161|B1|Baseline|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
22884|NCT02527161|P1|Participant Flow|ShapeMatch® Cutting Guides With Triathlon®|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
22885|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
22886|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
22887|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
22888|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
22889|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
22890|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
22891|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
22892|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
22893|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
22894|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
22895|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
22896|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
22897|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
22898|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
22899|NCT02527161|E1|Reported Event|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
22900|NCT02527148|B3|Baseline|Total|Total of all reporting groups
22959|NCT02525536|B4|Baseline|Total|Total of all reporting groups
22903|NCT02527148|P2|Participant Flow|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
22904|NCT02527148|P1|Participant Flow|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
22905|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
22906|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
22907|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
22908|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
22909|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
22910|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
22911|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
22912|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
22913|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
22914|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
22915|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
22916|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
22917|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
22918|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
22919|NCT02527148|E2|Reported Event|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
22920|NCT02527148|E1|Reported Event|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
22921|NCT02526550|B1|Baseline|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh~Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh~Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
22922|NCT02526550|P1|Participant Flow|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh~Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh~Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
22923|NCT02526550|O1|Outcome|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh~Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh~Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
22924|NCT02526550|O1|Outcome|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh~Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh~Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
22960|NCT02525536|B3|Baseline|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23259|NCT02519595|E3|Reported Event|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
24836|NCT02498652|O5|Outcome|Treatment R2|Allopurinol 300 mg qd + RDEA3170 5 mg qd (Cohort 2)
22925|NCT02526550|O1|Outcome|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh~Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh~Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
22926|NCT02526550|E1|Reported Event|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh~Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh~Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
22927|NCT02526524|B7|Baseline|Total|Total of all reporting groups
22928|NCT02526524|B6|Baseline|2000 mg Met IR|"1000 mg metformin immediate-release twice daily~Met IR: metformin immediate-release tablets"
22929|NCT02526524|B5|Baseline|Placebo|"placebo match for 600 and 1200 mg Met DR qAM treatment groups (Placebo 1) and placebo match for 900 and 1500 mg Met DR qAM treatment groups (Placebo 2)~Placebo"
22930|NCT02526524|B4|Baseline|1500 mg Met DR qAM|"1500 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
22931|NCT02526524|B3|Baseline|1200 mg Met DR qAM|"1200 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
22932|NCT02526524|B2|Baseline|900 mg Met DR qAM|"900 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
22933|NCT02526524|B1|Baseline|600 mg Met DR qAM|"600 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
22934|NCT02526524|P6|Participant Flow|2000 mg Met IR|"1000 mg metformin immediate-release twice daily~Met IR: metformin immediate-release tablets"
22935|NCT02526524|P5|Participant Flow|Placebo|"placebo match for 600 and 1200 mg Met DR qAM treatment groups (Placebo 1) and placebo match for 900 and 1500 mg Met DR qAM treatment groups (Placebo 2)~Placebo"
22936|NCT02526524|P4|Participant Flow|1500 mg Met DR qAM|"1500 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
22937|NCT02526524|P3|Participant Flow|1200 mg Met DR qAM|"1200 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
22938|NCT02526524|P2|Participant Flow|900 mg Met DR qAM|"900 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
22939|NCT02526524|P1|Participant Flow|600 mg Met DR qAM|"600 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
22940|NCT02526524|O6|Outcome|2000 mg Met IR|"1000 mg metformin immediate-release twice daily~Met IR: metformin immediate-release tablets"
22941|NCT02526524|O5|Outcome|Placebo|"placebo match for 600 and 1200 mg Met DR qAM treatment groups (Placebo 1) and placebo match for 900 and 1500 mg Met DR qAM treatment groups (Placebo 2)~Placebo"
22942|NCT02526524|O4|Outcome|1500 mg Met DR qAM|"1500 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
22943|NCT02526524|O3|Outcome|1200 mg Met DR qAM|"1200 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
22944|NCT02526524|O2|Outcome|900 mg Met DR qAM|"900 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
22945|NCT02526524|O1|Outcome|600 mg Met DR qAM|"600 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
22946|NCT02526524|E6|Reported Event|2000 mg Met IR|"1000 mg metformin immediate-release twice daily~Met IR: metformin immediate-release tablets"
22947|NCT02526524|E5|Reported Event|Placebo|"placebo match for 600 and 1200 mg Met DR qAM treatment groups (Placebo 1) and placebo match for 900 and 1500 mg Met DR qAM treatment groups (Placebo 2)~Placebo"
22948|NCT02526524|E4|Reported Event|1500 mg Met DR qAM|"1500 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
22949|NCT02526524|E3|Reported Event|1200 mg Met DR qAM|"1200 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
22950|NCT02526524|E2|Reported Event|900 mg Met DR qAM|"900 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
22951|NCT02526524|E1|Reported Event|600 mg Met DR qAM|"600 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
22952|NCT02526290|B1|Baseline|Active - Device|The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration. Intranasal Lacrimal Neurostimulator (Oculeve): Neurostimulation device
22953|NCT02526290|P1|Participant Flow|Active - Device|The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration. Intranasal Lacrimal Neurostimulator (Oculeve): Neurostimulation device
22954|NCT02526290|O1|Outcome|Active - Device|The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration. Intranasal Lacrimal Neurostimulator (Oculeve): Neurostimulation device
22955|NCT02526290|O1|Outcome|Active - Device|The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration. Intranasal Lacrimal Neurostimulator (Oculeve): Neurostimulation device
22956|NCT02526290|O1|Outcome|Active - Device|The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration. Intranasal Lacrimal Neurostimulator (Oculeve): Neurostimulation device
22957|NCT02526290|O1|Outcome|Active - Device|The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration. Intranasal Lacrimal Neurostimulator (Oculeve): Neurostimulation device
22958|NCT02526290|E1|Reported Event|Active - Device|The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration. Intranasal Lacrimal Neurostimulator (Oculeve): Neurostimulation device
22961|NCT02525536|B2|Baseline|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22962|NCT02525536|B1|Baseline|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22963|NCT02525536|P3|Participant Flow|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22964|NCT02525536|P2|Participant Flow|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22965|NCT02525536|P1|Participant Flow|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22966|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22967|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22968|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22969|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22970|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22971|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22972|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22973|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22974|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22975|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22976|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22977|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22978|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22979|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22980|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22981|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
24812|NCT02498652|O2|Outcome|Cohort 2|RDEA3170 5 mg, 10 mg 20 mg qd in combination with allopurinol 300 mg (qd and bid)
22982|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22983|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22984|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22985|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22986|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22987|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22988|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22989|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22990|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22991|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22992|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22993|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22994|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22995|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22996|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22997|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22998|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
22999|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23000|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23001|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23002|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
24813|NCT02498652|O1|Outcome|Cohort 1|RDEA3170 2.5 mg, 7.5 mg and 15 mg qd in combination with allopurinol 300 mg (qd and bid)
23003|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23004|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23005|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23006|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23007|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23008|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23009|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23010|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23011|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23012|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23013|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23014|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23015|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23016|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23017|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23018|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23019|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23020|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23021|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23022|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23023|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
24814|NCT02498652|O9|Outcome|Treatment R6|Allopurinol 300 mg qd + RDEA3170 20 mg qd (Cohort 2)
23024|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23025|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23026|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23027|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23028|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23029|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23030|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23031|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23032|NCT02525536|E3|Reported Event|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23033|NCT02525536|E2|Reported Event|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23034|NCT02525536|E1|Reported Event|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
23035|NCT02525094|B3|Baseline|Total|Total of all reporting groups
23036|NCT02525094|B2|Baseline|MEDI9929 280 mg|Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23037|NCT02525094|B1|Baseline|Placebo|Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23038|NCT02525094|P2|Participant Flow|MEDI9929 280 mg|Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23039|NCT02525094|P1|Participant Flow|Placebo|Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23040|NCT02525094|O2|Outcome|MEDI9929 280 mg|Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23041|NCT02525094|O1|Outcome|Placebo|Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23042|NCT02525094|O1|Outcome|MEDI9929 280 mg|Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23043|NCT02525094|O2|Outcome|MEDI9929 280 mg|Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23157|NCT02522624|P2|Participant Flow|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
24900|NCT02497976|B3|Baseline|Total|Total of all reporting groups
23044|NCT02525094|O1|Outcome|Placebo|Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23045|NCT02525094|O2|Outcome|MEDI9929 280 mg|Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23046|NCT02525094|O1|Outcome|Placebo|Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23047|NCT02525094|O2|Outcome|MEDI9929 280 mg|Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23048|NCT02525094|O1|Outcome|Placebo|Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23049|NCT02525094|O2|Outcome|MEDI9929 280 mg|Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23050|NCT02525094|O1|Outcome|Placebo|Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23051|NCT02525094|O2|Outcome|MEDI9929 280 mg|Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23052|NCT02525094|O1|Outcome|Placebo|Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23053|NCT02525094|O2|Outcome|MEDI9929 280 mg|Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23054|NCT02525094|O1|Outcome|Placebo|Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23055|NCT02525094|O2|Outcome|MEDI9929 280 mg|Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23056|NCT02525094|O1|Outcome|Placebo|Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23057|NCT02525094|O2|Outcome|MEDI9929 280 mg|Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23058|NCT02525094|O1|Outcome|Placebo|Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23059|NCT02525094|O2|Outcome|MEDI9929 280 mg|Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23060|NCT02525094|O1|Outcome|Placebo|Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23061|NCT02525094|O2|Outcome|MEDI9929 280 mg|Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23062|NCT02525094|O1|Outcome|Placebo|Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23063|NCT02525094|E2|Reported Event|MEDI9929 280 mg|Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23064|NCT02525094|E1|Reported Event|Placebo|Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
23065|NCT02524665|B1|Baseline|MAXCLARITY II + Murad|MAXCLARITY II was a 2.5 percent (%) benzoyl peroxide (BPO) foam cleanser and foam treatment, 0.5% salicylic acid (SA) toner foam. Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. Both treatments were applied topically to 1 side of face twice daily (BD) for 8 weeks. MAXCLARITY II application: Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in ante meridiem (AM) and toner foam in post meridiem (PM). Murad application: In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
23066|NCT02524665|P1|Participant Flow|MAXCLARITY II + Murad|MaxClarity II was a 2.5 percent (%) benzoyl peroxide (BPO) foam cleanser and foam treatment, 0.5% salicylic acid (SA) toner foam. Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. Both treatments were applied topically to 1 side of face twice daily (BD) for 8 weeks. MaxClarity II application: Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in ante meridiem (AM) and toner foam in post meridiem (PM). Murad application: In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
23067|NCT02524665|O2|Outcome|Murad|Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. It was applied topically to 1 side of face BD for 8 weeks. In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
23068|NCT02524665|O1|Outcome|MAXCLARITY II|MAXCLARITY II was a 2.5% BPO foam cleanser and foam treatment, 0.5% SA toner foam. It was applied topically to 1 side of face BD for 8 weeks. Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in AM and toner foam in PM.
23069|NCT02524665|O2|Outcome|Murad|Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. It was applied topically to 1 side of face BD for 8 weeks. In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
23070|NCT02524665|O1|Outcome|MAXCLARITY II|MAXCLARITY II was a 2.5% BPO foam cleanser and foam treatment, 0.5% SA toner foam. It was applied topically to 1 side of face BD for 8 weeks. Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in AM and toner foam in PM.
23071|NCT02524665|O2|Outcome|Murad|Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. It was applied topically to 1 side of face BD for 8 weeks. In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
23072|NCT02524665|O1|Outcome|MAXCLARITY II|MAXCLARITY II was a 2.5% BPO foam cleanser and foam treatment, 0.5% SA toner foam. It was applied topically to 1 side of face BD for 8 weeks. Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in AM and toner foam in PM.
23073|NCT02524665|O2|Outcome|Murad|Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. It was applied topically to 1 side of face BD for 8 weeks. In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
23074|NCT02524665|O1|Outcome|MAXCLARITY II|MAXCLARITY II was a 2.5% BPO foam cleanser and foam treatment, 0.5% SA toner foam. It was applied topically to 1 side of face BD for 8 weeks. Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in AM and toner foam in PM.
23075|NCT02524665|O2|Outcome|Murad|Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. It was applied topically to 1 side of face BD for 8 weeks. In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
23076|NCT02524665|O1|Outcome|MAXCLARITY II|MAXCLARITY II was a 2.5% BPO foam cleanser and foam treatment, 0.5% SA toner foam. It was applied topically to 1 side of face BD for 8 weeks. Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in AM and toner foam in PM.
23077|NCT02524665|O2|Outcome|Murad|Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. It was applied topically to 1 side of face BD for 8 weeks. In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
23078|NCT02524665|O1|Outcome|MAXCLARITY II|MAXCLARITY II was a 2.5% BPO foam cleanser and foam treatment, 0.5% SA toner foam. It was applied topically to 1 side of face BD for 8 weeks. Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in AM and toner foam in PM.
23079|NCT02524665|E1|Reported Event|MAXCLARITY II + Murad|MAXCLARITY II was a 2.5 percent (%) benzoyl peroxide (BPO) foam cleanser and foam treatment, 0.5% salicylic acid (SA) toner foam. Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. Both treatments were applied topically to 1 side of face twice daily (BD) for 8 weeks. MAXCLARITY II application: Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in ante meridiem (AM) and toner foam in post meridiem (PM). Murad application: In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
23080|NCT02524561|B4|Baseline|Total|Total of all reporting groups
23081|NCT02524561|B3|Baseline|Placebo|"Placebo tablet, placebo patch, placebo progesterone~Placebo tablet: Placebo tablet~Placebo patch: placebo patch~Placebo progesterone: placebo progesterone"
23082|NCT02524561|B2|Baseline|Estradiol Patch, Active Progesterone|"Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Estradiol patch: Climara 50 mcg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo tablet: Placebo tablet"
23083|NCT02524561|B1|Baseline|CEE Pill, Active Progesterone|"Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~CEE pill: Conjugated equine estrogens 0.45 mg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo patch: placebo patch"
23084|NCT02524561|P3|Participant Flow|Placebo|"Placebo tablet, placebo patch, placebo progesterone~Placebo tablet: Placebo tablet~Placebo patch: placebo patch~Placebo progesterone: placebo progesterone"
23085|NCT02524561|P2|Participant Flow|Estradiol Patch, Active Progesterone|"Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Estradiol patch: Climara 50 mcg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo tablet: Placebo tablet"
23086|NCT02524561|P1|Participant Flow|CEE Pill, Active Progesterone|"Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~CEE pill: Conjugated equine estrogens 0.45 mg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo patch: placebo patch"
23087|NCT02524561|O3|Outcome|Placebo|"Placebo tablet, placebo patch, placebo progesterone~Placebo tablet: Placebo tablet~Placebo patch: placebo patch~Placebo progesterone: placebo progesterone"
23088|NCT02524561|O2|Outcome|Estradiol Patch, Active Progesterone|"Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Estradiol patch: Climara 50 mcg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo tablet: Placebo tablet"
23089|NCT02524561|O1|Outcome|CEE Pill, Active Progesterone|"Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~CEE pill: Conjugated equine estrogens 0.45 mg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo patch: placebo patch"
23090|NCT02524561|O3|Outcome|Placebo|"Placebo tablet, placebo patch, placebo progesterone~Placebo tablet: Placebo tablet~Placebo patch: placebo patch~Placebo progesterone: placebo progesterone"
23091|NCT02524561|O2|Outcome|Estradiol Patch, Active Progesterone|"Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Estradiol patch: Climara 50 mcg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo tablet: Placebo tablet"
23092|NCT02524561|O1|Outcome|CEE Pill, Active Progesterone|"Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~CEE pill: Conjugated equine estrogens 0.45 mg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo patch: placebo patch"
23093|NCT02524561|O3|Outcome|Placebo|"Placebo tablet, placebo patch, placebo progesterone~Placebo tablet: Placebo tablet~Placebo patch: placebo patch~Placebo progesterone: placebo progesterone"
23094|NCT02524561|O2|Outcome|Estradiol Patch, Active Progesterone|"Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Estradiol patch: Climara 50 mcg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo tablet: Placebo tablet"
23260|NCT02519595|E2|Reported Event|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
23095|NCT02524561|O1|Outcome|CEE Pill, Active Progesterone|"Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~CEE pill: Conjugated equine estrogens 0.45 mg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo patch: placebo patch"
23096|NCT02524561|O3|Outcome|Placebo|"Placebo tablet, placebo patch, placebo progesterone~Placebo tablet: Placebo tablet~Placebo patch: placebo patch~Placebo progesterone: placebo progesterone"
23097|NCT02524561|O2|Outcome|Estradiol Patch, Active Progesterone|"Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Estradiol patch: Climara 50 mcg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo tablet: Placebo tablet"
23098|NCT02524561|O1|Outcome|CEE Pill, Active Progesterone|"Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~CEE pill: Conjugated equine estrogens 0.45 mg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo patch: placebo patch"
23099|NCT02524561|E3|Reported Event|Placebo|"Placebo tablet, placebo patch, placebo progesterone~Placebo tablet: Placebo tablet~Placebo patch: placebo patch~Placebo progesterone: placebo progesterone"
23100|NCT02524561|E2|Reported Event|Estradiol Patch, Active Progesterone|"Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Estradiol patch: Climara 50 mcg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo tablet: Placebo tablet"
23101|NCT02524561|E1|Reported Event|CEE Pill, Active Progesterone|"Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~CEE pill: Conjugated equine estrogens 0.45 mg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo patch: placebo patch"
23102|NCT02524418|B1|Baseline|Cholangiopancreatoscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
23103|NCT02524418|P1|Participant Flow|Cholangiopancreatoscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
23104|NCT02524418|O1|Outcome|Cholangioscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
23105|NCT02524418|O1|Outcome|Cholangioscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
23106|NCT02524418|O1|Outcome|Cholangioscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
23107|NCT02524418|O2|Outcome|Pancreatoscopy|Subject who had a Pancreatoscopy as part of their ERCP
23108|NCT02524418|O1|Outcome|Cholangioscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
23109|NCT02524418|O1|Outcome|Cholangiopancreatoscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
23110|NCT02524418|O1|Outcome|Cholangiopancreatoscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
23111|NCT02524418|O1|Outcome|Cholangiopancreatoscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
23112|NCT02524418|O1|Outcome|Cholangiopancreatoscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
23113|NCT02524418|O2|Outcome|Pancreatoscopy|These are the subjects who had evaluation of their pancreas ducts during the Spyglass ERCP
23114|NCT02524418|O1|Outcome|Cholangioscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
23261|NCT02519595|E1|Reported Event|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
24815|NCT02498652|O8|Outcome|Treatment R5|Allopurinol 300 mg qd + RDEA3170 15 mg qd (Cohort 1)
23115|NCT02524418|E1|Reported Event|Cholangiopancreatoscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
23116|NCT02524288|B1|Baseline|ENG-E2 125 μg/300 μg|Participants were to receive up to 13 cycles of Etonogestrel (ENG) 125 μg and 17β-Estradiol (E2) 300 μg. Each cycle would consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
23117|NCT02524288|P1|Participant Flow|ENG-E2 125 μg/300 μg|Participants were to receive up to 13 cycles of Etonogestrel (ENG) 125 μg and 17β-Estradiol (E2) 300 μg. Each cycle would consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
23118|NCT02524288|O1|Outcome|ENG-E2 125 μg/300 μg|Participants were to receive up to 13 cycles of Etonogestrel (ENG) 125 μg and 17β-Estradiol (E2) 300 μg. Each cycle would consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
23119|NCT02524288|O1|Outcome|ENG-E2 125 μg/300 μg|Participants were to receive up to 13 cycles of Etonogestrel (ENG) 125 μg and 17β-Estradiol (E2) 300 μg. Each cycle would consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
23120|NCT02524288|O1|Outcome|ENG-E2 125 μg/300 μg|Participants were to receive up to 13 cycles of Etonogestrel (ENG) 125 μg and 17β-Estradiol (E2) 300 μg. Each cycle would consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
23121|NCT02524288|O1|Outcome|ENG-E2 125 μg/300 μg|Participants were to receive up to 13 cycles of Etonogestrel (ENG) 125 μg and 17β-Estradiol (E2) 300 μg. Each cycle would consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
23122|NCT02524288|O1|Outcome|ENG-E2 125 μg/300 μg|Participants were to receive up to 13 cycles of Etonogestrel (ENG) 125 μg and 17β-Estradiol (E2) 300 μg. Each cycle would consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
23123|NCT02524288|E1|Reported Event|ENG-E2 125 μg/300 μg|Participants were to receive up to 13 cycles of Etonogestrel (ENG) 125 μg and 17β-Estradiol (E2) 300 μg. Each cycle would consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
23124|NCT02524158|B3|Baseline|Total|Total of all reporting groups
23125|NCT02524158|B2|Baseline|Delayed Treatment Control - Usual Care|Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
23126|NCT02524158|B1|Baseline|Yoga|The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.
23127|NCT02524158|P2|Participant Flow|Delayed Treatment Control - Usual Care|Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
23128|NCT02524158|P1|Participant Flow|Yoga|The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.
23129|NCT02524158|O2|Outcome|Delayed Treatment Control - Usual Care|Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
23130|NCT02524158|O1|Outcome|Yoga|The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.
23131|NCT02524158|O2|Outcome|Delayed Treatment Control - Usual Care|Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
23132|NCT02524158|O1|Outcome|Yoga|The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.
23133|NCT02524158|O2|Outcome|Delayed Treatment Control - Usual Care|Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
23262|NCT02519387|B1|Baseline|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
23134|NCT02524158|O1|Outcome|Yoga|The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.
23135|NCT02524158|O2|Outcome|Delayed Treatment Control - Usual Care|Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
23136|NCT02524158|O1|Outcome|Yoga|The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.
23137|NCT02524158|E2|Reported Event|Delayed Treatment Control - Usual Care|Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
23138|NCT02524158|E1|Reported Event|Yoga|The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.
23139|NCT02524054|B3|Baseline|Total|Total of all reporting groups
23140|NCT02524054|B2|Baseline|Aerosol Furosemide Study 2b|Inhalation of furosemide aerosol or placebo saline aerosol over the course of 10-15 min. Single administration of furosemide aerosol on one treatment day, and a single administration of saline aerosol on a separate treatment day. Order of Furosemide Treatment Day and Placebo Treatment Day is randomized.
23141|NCT02524054|B1|Baseline|Aerosol Furosemide Study 2a|Subjects will inhale 40mg of furosemide aerosol over the course of 10-15 min. This will be a single, unblinded administration.
23142|NCT02524054|P3|Participant Flow|Experimental: Aerosol Furosemide Study 2b Arm S|Inhalation of saline aerosol one one day then furosemide aerosol on another day. Baseline measurement 15 min; Inhalation over the course of 10-15 min.; outcome measurement 15 min. Watch for adverse effects 2 hours.
23143|NCT02524054|P2|Participant Flow|Aerosol Furosemide Study 2b Arm F|Inhalation of furosemide aerosol one one day then placebo saline aerosol on another day. Baseline measurement 15 min; Inhalation over the course of 10-15 min.; outcome measurement 15 min. Watch for adverse effects 2 hours.
23144|NCT02524054|P1|Participant Flow|Aerosol Furosemide Study 2a|Subjects will inhale 40mg of furosemide aerosol over the course of 10-15 min. This will be a single, unblinded administration.
23145|NCT02524054|O3|Outcome|Aerosol Saline Study 2b|"Inhalation of placebo saline aerosol over the course of 10-15 min.~Across the study 2b, these subjects experienced a single administration of furosemide aerosol on one treatment day, and a single administration of saline aerosol on a separate treatment day. Order of Furosemide Treatment Day and Placebo Treatment Day is randomized."
23146|NCT02524054|O2|Outcome|Aerosol Furosemide Study 2b|"Inhalation of furosemide aerosol over the course of 10-15 min.~Across the study 2b, these subjects experienced a single administration of furosemide aerosol on one treatment day, and a single administration of saline aerosol on a separate treatment day. Order of Furosemide Treatment Day and Placebo Treatment Day is randomized."
23147|NCT02524054|O1|Outcome|Aerosol Furosemide Study 2a|Subjects will inhale 40mg of furosemide aerosol over the course of 10-15 min. This will be a single, unblinded administration.
23148|NCT02524054|O3|Outcome|Aerosol Saline Study 2b|Inhalation of saline aerosol . Baseline measurement 15 min; Inhalation over the course of 10-15 min.; outcome measurement 15 min. Watch for adverse effects 2 hours.
23149|NCT02524054|O2|Outcome|Aerosol Furosemide Study 2b|Inhalation of furosemide aerosol. Baseline measurement 15 min; Inhalation over the course of 10-15 min.; outcome measurement 15 min. Watch for adverse effects 2 hours.
23150|NCT02524054|O1|Outcome|Aerosol Furosemide Study 2a|Subjects will inhale 40mg of furosemide aerosol over the course of 10-15 min. This will be a single, unblinded administration.
23151|NCT02524054|E3|Reported Event|Aerosol Saline Study 2b|Inhalation of placebo saline aerosol over the course of 10-15 min. Single administration of saline aerosol. Order of Furosemide Treatment Day and Placebo Treatment Day is randomized.
23152|NCT02524054|E2|Reported Event|Aerosol Furosemide Study 2b|Inhalation of furosemide aerosol over the course of 10-15 min. Single administration of furosemide aerosol on one treatment day. Order of Furosemide Treatment Day and Placebo Treatment Day is randomized.
23153|NCT02524054|E1|Reported Event|Aerosol Furosemide Study 2a|Subjects will inhale 40mg of furosemide aerosol over the course of 10-15 min. This will be a single, unblinded administration.
23154|NCT02522624|B3|Baseline|Total|Total of all reporting groups
23155|NCT02522624|B2|Baseline|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
23156|NCT02522624|B1|Baseline|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
24816|NCT02498652|O7|Outcome|Treatment R4|Allopurinol 300 mg qd + RDEA3170 10 mg qd (Cohort 2)
23158|NCT02522624|P1|Participant Flow|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
23159|NCT02522624|O2|Outcome|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
23160|NCT02522624|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
23161|NCT02522624|O2|Outcome|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
23162|NCT02522624|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
23163|NCT02522624|O2|Outcome|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
23164|NCT02522624|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
23165|NCT02522624|O2|Outcome|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
23166|NCT02522624|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
23167|NCT02522624|O2|Outcome|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
23168|NCT02522624|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
23169|NCT02522624|O2|Outcome|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
23170|NCT02522624|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
23171|NCT02522624|E2|Reported Event|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
23172|NCT02522624|E1|Reported Event|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
23173|NCT02520726|B3|Baseline|Total|Total of all reporting groups
23174|NCT02520726|B2|Baseline|Placebo|"Placebo 1 capsule PO qday for one week, then 2 capsules PO qday for one week, then 3 capsules PO qday for one week, then 4 capsules PO qday for one week.~Sertraline: < 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop."
23175|NCT02520726|B1|Baseline|Sertraline|"Patients age 18-65: sertraline 50mg PO qday for one week, then 100mg PO qday for one week, then 150mg PO qday for one week, then 200mg PO qday for one week, with flexible titration. Patient age >65: sertraline 25mg PO qday for one week, then 50mg PO qday for one week, then 75mg PO qday for one week, then 100mg PO qday for one week, with flexible titration~Sertraline: < 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop."
23176|NCT02520726|P2|Participant Flow|Placebo|"Placebo 1 capsule PO qday for one week, then 2 capsules PO qday for one week, then 3 capsules PO qday for one week, then 4 capsules PO qday for one week.~Sertraline: < 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop."
23177|NCT02520726|P1|Participant Flow|Sertraline|"Patients age 18-65: sertraline 50mg PO qday for one week, then 100mg PO qday for one week, then 150mg PO qday for one week, then 200mg PO qday for one week, with flexible titration. Patient age >65: sertraline 25mg PO qday for one week, then 50mg PO qday for one week, then 75mg PO qday for one week, then 100mg PO qday for one week, with flexible titration~Sertraline: < 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop."
23178|NCT02520726|O2|Outcome|Placebo|"Placebo 1 capsule PO qday for one week, then 2 capsules PO qday for one week, then 3 capsules PO qday for one week, then 4 capsules PO qday for one week.~Sertraline: < 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop."
23179|NCT02520726|O1|Outcome|Sertraline|"Patients age 18-65: sertraline 50mg PO qday for one week, then 100mg PO qday for one week, then 150mg PO qday for one week, then 200mg PO qday for one week, with flexible titration. Patient age >65: sertraline 25mg PO qday for one week, then 50mg PO qday for one week, then 75mg PO qday for one week, then 100mg PO qday for one week, with flexible titration~Sertraline: < 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop."
23180|NCT02520726|O2|Outcome|Placebo|"Placebo 1 capsule PO qday for one week, then 2 capsules PO qday for one week, then 3 capsules PO qday for one week, then 4 capsules PO qday for one week.~Sertraline: < 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop."
24817|NCT02498652|O6|Outcome|Treatment R3|Allopurinol 300 mg qd + RDEA3170 7.5 mg qd (Cohort 1)
23181|NCT02520726|O1|Outcome|Sertraline|"Patients age 18-65: sertraline 50mg PO qday for one week, then 100mg PO qday for one week, then 150mg PO qday for one week, then 200mg PO qday for one week, with flexible titration. Patient age >65: sertraline 25mg PO qday for one week, then 50mg PO qday for one week, then 75mg PO qday for one week, then 100mg PO qday for one week, with flexible titration~Sertraline: < 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop."
23182|NCT02520726|E2|Reported Event|Placebo|"Placebo 1 capsule PO qday for one week, then 2 capsules PO qday for one week, then 3 capsules PO qday for one week, then 4 capsules PO qday for one week.~Sertraline: < 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop."
23183|NCT02520726|E1|Reported Event|Sertraline|"Patients age 18-65: sertraline 50mg PO qday for one week, then 100mg PO qday for one week, then 150mg PO qday for one week, then 200mg PO qday for one week, with flexible titration. Patient age >65: sertraline 25mg PO qday for one week, then 50mg PO qday for one week, then 75mg PO qday for one week, then 100mg PO qday for one week, with flexible titration~Sertraline: < 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop."
23184|NCT02520414|B1|Baseline|Symphion®|"Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.~Symphion® Bipolar Hysteroscopic Tissue Resection System"
23185|NCT02520414|P1|Participant Flow|Symphion®|"Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.~Symphion® Bipolar Hysteroscopic Tissue Resection System"
23186|NCT02520414|O1|Outcome|Symphion®|"Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.~Symphion® Bipolar Hysteroscopic Tissue Resection System"
23187|NCT02520414|E1|Reported Event|Symphion®|"Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.~Symphion® Bipolar Hysteroscopic Tissue Resection System"
23188|NCT02519855|B3|Baseline|Total|Total of all reporting groups
23189|NCT02519855|B2|Baseline|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
23190|NCT02519855|B1|Baseline|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
23191|NCT02519855|P2|Participant Flow|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
23192|NCT02519855|P1|Participant Flow|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
23193|NCT02519855|O2|Outcome|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
23194|NCT02519855|O1|Outcome|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
23195|NCT02519855|O2|Outcome|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
23196|NCT02519855|O1|Outcome|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
23197|NCT02519855|O2|Outcome|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
23198|NCT02519855|O1|Outcome|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
23199|NCT02519855|O2|Outcome|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
23200|NCT02519855|O1|Outcome|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
23201|NCT02519855|O2|Outcome|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
23202|NCT02519855|O1|Outcome|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
23203|NCT02519855|O2|Outcome|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
23204|NCT02519855|O1|Outcome|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
23205|NCT02519855|E2|Reported Event|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
23206|NCT02519855|E1|Reported Event|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
23207|NCT02519842|B3|Baseline|Total|Total of all reporting groups
23208|NCT02519842|B2|Baseline|Control Regimen Cycle 1|Participants received a single dose of matched placebo for fosaprepitant IV on Day 1 prior to chemotherapy plus ondansetron IV on Day 1 prior to chemotherapy and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may have also received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
23209|NCT02519842|B1|Baseline|Fosaprepitant Regimen Cycle 1|Participants received a single dose of fosaprepitant 150 mg (or age-based adjustment) administered intravenously (IV) on Day 1 prior to chemotherapy plus ondansetron IV on Day 1 prior to chemotherapy and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may have also received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
23210|NCT02519842|P3|Participant Flow|Fosaprepitant Regimen Cycles 2-6|Participants received a single dose of fosaprepitant 150 mg (or age-based adjustment) IV on Day 1 prior to chemotherapy plus a 5-hydroxytryptamine 3 (5-HT3) antagonist on Day 1 prior to chemotherapy and per product label or standard of care. Participants may also have received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
23211|NCT02519842|P2|Participant Flow|Control Regimen Cycle 1|Participants received a single dose of matched placebo for fosaprepitant IV on Day 1 prior to chemotherapy plus ondansetron IV on Day 1 prior to chemotherapy and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may have also received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
23228|NCT02519842|E2|Reported Event|Control Regimen Cycle 1|Participants received a single dose of matched placebo for fosaprepitant IV on Day 1 prior to chemotherapy plus ondansetron IV on Day 1 prior to chemotherapy and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may have also received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
23212|NCT02519842|P1|Participant Flow|Fosaprepitant Regimen Cycle 1|Participants received a single dose of fosaprepitant 150 mg (or age-based adjustment) administered intravenously (IV) on Day 1 prior to chemotherapy plus ondansetron IV on Day 1 prior to chemotherapy and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may have also received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
23213|NCT02519842|O2|Outcome|Control Regimen Cycle 1|Participants received a single dose of matched placebo for fosaprepitant IV on Day 1 prior to chemotherapy plus ondansetron IV on Day 1 prior to chemotherapy and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may have also received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
23214|NCT02519842|O1|Outcome|Fosaprepitant Regimen Cycle 1|Participants received a single dose of fosaprepitant 150 mg (or age-based adjustment) administered intravenously (IV) on Day 1 prior to chemotherapy plus ondansetron IV on Day 1 prior to chemotherapy and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may have also received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
23215|NCT02519842|O2|Outcome|Control Regimen Cycle 1|Participants received a single dose of matched placebo for fosaprepitant IV on Day 1 prior to chemotherapy plus ondansetron IV on Day 1 prior to chemotherapy and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may have also received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
23216|NCT02519842|O1|Outcome|Fosaprepitant Regimen Cycle 1|Participants received a single dose of fosaprepitant 150 mg (or age-based adjustment) administered intravenously (IV) on Day 1 prior to chemotherapy plus ondansetron IV on Day 1 prior to chemotherapy and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may have also received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
23217|NCT02519842|O2|Outcome|Control Regimen Cycle 1|Participants received a single dose of matched placebo for fosaprepitant IV on Day 1 prior to chemotherapy plus ondansetron IV on Day 1 prior to chemotherapy and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may have also received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
23218|NCT02519842|O1|Outcome|Fosaprepitant Regimen Cycle 1|Participants received a single dose of fosaprepitant 150 mg (or age-based adjustment) administered intravenously (IV) on Day 1 prior to chemotherapy plus ondansetron IV on Day 1 prior to chemotherapy and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may have also received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
23219|NCT02519842|O3|Outcome|Fosaprepitant Regimen Cycles 2-6|Participants received a single dose of fosaprepitant 150 mg (or age-based adjustment) IV on Day 1 prior to chemotherapy plus a 5-HT3 antagonist on Day 1 prior to chemotherapy and per product label or standard of care. Participants may also have received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
23220|NCT02519842|O2|Outcome|Control Regimen Cycle 1|Participants received a single dose of matched placebo for fosaprepitant IV on Day 1 prior to chemotherapy plus ondansetron IV on Day 1 prior to chemotherapy and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may have also received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
23221|NCT02519842|O1|Outcome|Fosaprepitant Regimen Cycle 1|Participants received a single dose of fosaprepitant 150 mg (or age-based adjustment) administered intravenously (IV) on Day 1 prior to chemotherapy plus ondansetron IV on Day 1 prior to chemotherapy and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may have also received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
23222|NCT02519842|O3|Outcome|Fosaprepitant Regimen Cycles 2-6|Participants received a single dose of fosaprepitant 150 mg (or age-based adjustment) IV on Day 1 prior to chemotherapy plus a 5-HT3 antagonist on Day 1 prior to chemotherapy and per product label or standard of care. Participants may also have received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
23223|NCT02519842|O2|Outcome|Control Regimen Cycle 1|Participants received a single dose of matched placebo for fosaprepitant IV on Day 1 prior to chemotherapy plus ondansetron IV on Day 1 prior to chemotherapy and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may have also received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
23224|NCT02519842|O1|Outcome|Fosaprepitant Regimen Cycle 1|Participants received a single dose of fosaprepitant 150 mg (or age-based adjustment) administered intravenously (IV) on Day 1 prior to chemotherapy plus ondansetron IV on Day 1 prior to chemotherapy and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may have also received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
23225|NCT02519842|O2|Outcome|Control Regimen Cycle 1|Participants received a single dose of matched placebo for fosaprepitant IV on Day 1 prior to chemotherapy plus ondansetron IV on Day 1 prior to chemotherapy and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may have also received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
23226|NCT02519842|O1|Outcome|Fosaprepitant Regimen Cycle 1|Participants received a single dose of fosaprepitant 150 mg (or age-based adjustment) administered intravenously (IV) on Day 1 prior to chemotherapy plus ondansetron IV on Day 1 prior to chemotherapy and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may have also received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
23227|NCT02519842|E3|Reported Event|Fosaprepitant Regimen Cycles 2-6|Participants received a single dose of fosaprepitant 150 mg (or age-based adjustment) IV on Day 1 prior to chemotherapy plus a 5-hydroxytryptamine 3 (5-HT3) antagonist on Day 1 prior to chemotherapy and per product label or standard of care. Participants may also have received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
23229|NCT02519842|E1|Reported Event|Fosaprepitant Regimen Cycle 1|Participants received a single dose of fosaprepitant 150 mg (or age-based adjustment) administered intravenously (IV) on Day 1 prior to chemotherapy plus ondansetron IV on Day 1 prior to chemotherapy and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may have also received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
23230|NCT02519712|B1|Baseline|Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells|"This is a single center trial to assess the feasibility of standard induction chemotherapy followed by a single dose of unmanipulated G-PBSC for the treatment of elderly patients with newly diagnosed AML.~Adverse Events information cannot be separated by donors and recipients due to data privacy reasons."
23231|NCT02519712|P1|Participant Flow|Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells|"This is a single center trial to assess the feasibility of standard induction chemotherapy followed by a single dose of unmanipulated G-PBSC for the treatment of elderly patients with newly diagnosed AML.~Donors and participants are combined because the study was closed to poor accrual and there are no clinical results."
23232|NCT02519712|O1|Outcome|Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells|"This is a single center trial to assess the feasibility of standard induction chemotherapy followed by a single dose of unmanipulated G-PBSC for the treatment of elderly patients with newly diagnosed AML.~Induction Chemotherapy: Patients with newly diagnosed AML will receive standard induction chemotherapy with daunorubicin and cytarabine (7+3 scheme). Patients who achieve CR may undergo consolidation chemotherapy at the discretion of the treating leukemia physician.~G-PBSC Infusion: G-CSF-mobilized peripheral blood cells will be collected from the donors in the Donor Room according to standard MSKCC BMT guidelines. Patients will be infused by infusion of unmanipulated G-PBSC from a haploidentical related donor."
23233|NCT02519712|E1|Reported Event|Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells|"This is a single center trial to assess the feasibility of standard induction chemotherapy followed by a single dose of unmanipulated G-PBSC for the treatment of elderly patients with newly diagnosed AML.~Adverse Events information cannot be separated by donors and recipients due to data privacy reasons"
23234|NCT02519595|B4|Baseline|Total|Total of all reporting groups
23235|NCT02519595|B3|Baseline|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
23236|NCT02519595|B2|Baseline|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
23237|NCT02519595|B1|Baseline|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
23238|NCT02519595|P3|Participant Flow|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
23239|NCT02519595|P2|Participant Flow|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
23240|NCT02519595|P1|Participant Flow|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
23241|NCT02519595|O3|Outcome|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
23242|NCT02519595|O2|Outcome|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
23243|NCT02519595|O1|Outcome|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
23244|NCT02519595|O3|Outcome|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
23245|NCT02519595|O2|Outcome|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
23246|NCT02519595|O1|Outcome|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
23247|NCT02519595|O3|Outcome|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
23248|NCT02519595|O2|Outcome|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
23249|NCT02519595|O1|Outcome|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
23250|NCT02519595|O3|Outcome|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
23251|NCT02519595|O2|Outcome|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
23252|NCT02519595|O1|Outcome|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
23253|NCT02519595|O3|Outcome|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
23254|NCT02519595|O2|Outcome|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
23255|NCT02519595|O1|Outcome|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
23256|NCT02519595|O3|Outcome|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
23257|NCT02519595|O2|Outcome|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
23258|NCT02519595|O1|Outcome|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
23263|NCT02519387|P1|Participant Flow|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
23264|NCT02519387|O1|Outcome|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
23265|NCT02519387|O1|Outcome|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
23266|NCT02519387|O1|Outcome|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
23267|NCT02519387|O1|Outcome|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
23268|NCT02519387|O1|Outcome|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
23269|NCT02519387|E1|Reported Event|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
23270|NCT02518048|B1|Baseline|All Study Participants|"Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)~LEO 90100 Aerosol foam~Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)~Betesil® 2.25 mg"
23271|NCT02518048|P1|Participant Flow|LEO 90100 Aerosol Foam; Betesil® 2.25 mg|"Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)~LEO 90100 Aerosol foam~Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)~Betesil® 2.25 mg"
23272|NCT02518048|O2|Outcome|Betesil® 2.25 mg|"Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)~Betesil® 2.25 mg"
23273|NCT02518048|O1|Outcome|LEO 90100 Aerosol Foam|"Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)~LEO 90100 Aerosol foam"
23274|NCT02518048|O2|Outcome|Betesil® 2.25 mg|"Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)~Betesil® 2.25 mg"
23275|NCT02518048|O1|Outcome|LEO 90100 Aerosol Foam|"Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)~LEO 90100 Aerosol foam"
23276|NCT02518048|O2|Outcome|Betesil® 2.25 mg|"Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)~Betesil® 2.25 mg"
23277|NCT02518048|O1|Outcome|LEO 90100 Aerosol Foam|"Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)~LEO 90100 Aerosol foam"
23278|NCT02518048|O2|Outcome|Betesil® 2.25 mg|"Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)~Betesil® 2.25 mg"
23279|NCT02518048|O1|Outcome|LEO 90100 Aerosol Foam|"Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)~LEO 90100 Aerosol foam"
23280|NCT02518048|E1|Reported Event|All Subjects|All subjects received both medication and reporting is on the entire population.
23281|NCT02517580|B1|Baseline|Vitamin K2 (MK7)|Vitamin K2 (MK7) 360 mcg/day PO once daily for 8 weeks
23282|NCT02517580|P1|Participant Flow|Vitamin K2 (MK7)|Vitamin K2 (MK7) 360 mcg/day PO once daily for 8 weeks
23283|NCT02517580|O1|Outcome|Vitamin K2 (MK7)|"Vitamin K2 (MK7) 360 mcg/day PO once daily for 8 weeks~Vitamin K2 (MK7)"
23284|NCT02517580|E1|Reported Event|Vitamin K2 (MK7)|"Vitamin K2 (MK7) 360 mcg/day PO once daily for 8 weeks~Vitamin K2 (MK7)"
23285|NCT02517567|B1|Baseline|Overall|Delefilcon A, narafilcon A, and somofilcon A contact lenses worn bilaterally (in both eyes) and a period of no lens wear in a randomized crossover fashion
23286|NCT02517567|P4|Participant Flow|Sequence 4|No Lens/clariti/TruEye/DT1
23287|NCT02517567|P3|Participant Flow|Sequence 3|clariti/DT1/No Lens/TruEye
23288|NCT02517567|P2|Participant Flow|Sequence 2|TruEye/No Lens/DT1/clariti
23289|NCT02517567|P1|Participant Flow|Sequence 1|DAILIES TOTAL1 (DT1)/TruEye/clariti/No Lens
23290|NCT02517567|O2|Outcome|No Lens|One 8-hour day of no lens wear as part of the crossover sequence
23291|NCT02517567|O1|Outcome|Lens|Delefilcon A contact lenses, narafilcon A contact lenses, and somofilcon A contact lenses worn bilaterally in cross-over fashion as randomized. Each product worn for one day, 8 hours minimum.
23292|NCT02517567|E5|Reported Event|No Lens|"All subjects exposed to No lens wear for 8 hours during Period 1, 2, 3, or 4 as randomized"
23293|NCT02517567|E4|Reported Event|Clariti|All subjects exposed to clariti contact lenses worn for 8 hours during Period 1, 2, 3, or 4 as randomized
23294|NCT02517567|E3|Reported Event|TruEye|All subjects exposed to TruEye contact lenses worn for 8 hours during Period 1, 2, 3, or 4 as randomized
23295|NCT02517567|E2|Reported Event|DAILIES TOTAL1|All subjects exposed to DT1 contact lenses worn for 8 hours during Period 1, 2, 3, or 4 as randomized
23296|NCT02517567|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to exposure to the investigational product (including the ‘No Lens wear’ treatment)
23297|NCT02517515|B3|Baseline|Total|Total of all reporting groups
23298|NCT02517515|B2|Baseline|Double-blind Placebo Followed by Open-label 3-DAA|Double-blind placebo for 12 weeks, followed by open-label 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
23299|NCT02517515|B1|Baseline|Double-blind 3-DAA|Double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
23300|NCT02517515|P2|Participant Flow|Double-blind Placebo Followed by Open-label 3-DAA|Double-blind placebo for 12 weeks, followed by open-label 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
23301|NCT02517515|P1|Participant Flow|Double-blind 3-DAA|Double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
23387|NCT02515851|E1|Reported Event|Active Group|"Group that receives actual liposomal bupivacaine injections~Exparel"
23302|NCT02517515|O2|Outcome|Double-blind 3-DAA (Treatment-Experienced)|Participants who were treatment-experienced and received double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
23303|NCT02517515|O1|Outcome|Double-blind 3-DAA (Treatment-Naïve)|Participants who were treatment-naïve and received double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
23304|NCT02517515|O2|Outcome|Double-blind 3-DAA (Treatment-Experienced)|Participants who were treatment-experienced and received double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
23305|NCT02517515|O1|Outcome|Double-blind 3-DAA (Treatment-Naïve)|Participants who were treatment-naïve and received double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
23306|NCT02517515|O2|Outcome|Double-blind 3-DAA (Treatment-Experienced)|Participants who were treatment-experienced and received double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
23307|NCT02517515|O1|Outcome|Double-blind 3-DAA (Treatment-Naïve)|Participants who were treatment-naïve and received double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
23308|NCT02517515|O2|Outcome|Double-blind 3-DAA (Treatment-Experienced)|Participants who were treatment-experienced and received double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
23309|NCT02517515|O1|Outcome|Double-blind 3-DAA (Treatment-Naïve)|Participants who were treatment-naïve and received double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
23310|NCT02517515|O2|Outcome|Double-blind 3-DAA (Treatment-Experienced)|Participants who were treatment-experienced and received double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
23311|NCT02517515|O1|Outcome|Double-blind 3-DAA (Treatment-Naïve)|Participants who were treatment-naïve and received double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
23312|NCT02517515|E3|Reported Event|Open-label 3-DAA|Open-label 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
23313|NCT02517515|E2|Reported Event|Double-blind Placebo|Double-blind placebo for 12 weeks.
23314|NCT02517515|E1|Reported Event|Double-blind 3-DAA|Double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
23315|NCT02517047|B1|Baseline|CareTRx Device|"Subject will receive CareTRx device for rescue inhaler as well as the application downloaded to their Android phone. The device will track when the rescue inhaler is administered. The information will then be loaded to phone app.~CareTRx: CareTRx is a novel device that can be applied to most MDI (meter dose inhaler) device and leverages mobile and cloud computing to objectively assess and provide real-visualize feedback to patients and providers around medication adherence and disease control in pediatric asthma."
23316|NCT02517047|P1|Participant Flow|CareTRx Device|"Subject will receive CareTRx device for rescue inhaler as well as the application downloaded to their Android phone. The device will track when the rescue inhaler is administered. The information will then be loaded to phone app.~CareTRx: CareTRx is a novel device that can be applied to most MDI (meter dose inhaler) device and leverages mobile and cloud computing to objectively assess and provide real-visualize feedback to patients and providers around medication adherence and disease control in pediatric asthma."
23317|NCT02517047|O1|Outcome|CareTRx Device|"All eligible participants will receive CareTRx device for rescue inhaler as well as the application downloaded to their Android phone. CareTRx is a novel monitoring device that can be applied to most MDI (meter dose inhaler) device and leverages mobile and cloud computing to objectively assess and provide information to patients and providers around medication adherence and disease control in pediatric asthma. The information will then be loaded to phone app.~All data in the table represent values collected during the study and no placeholder values were used."
23318|NCT02517047|O1|Outcome|CareTRx Device|"All eligible participants will receive CareTRx device for rescue inhaler as well as the application downloaded to their Android phone. CareTRx is a novel monitoring device that can be applied to most MDI (meter dose inhaler) device and leverages mobile and cloud computing to objectively assess and provide information to patients and providers around medication adherence and disease control in pediatric asthma. The information will then be loaded to phone app.~All data in the table represent values collected during the study and no placeholder values were used."
23319|NCT02517047|O1|Outcome|CareTRx Device|"All eligible participants will receive CareTRx device for rescue inhaler as well as the application downloaded to their Android phone. CareTRx is a novel monitoring device that can be applied to most MDI (meter dose inhaler) device and leverages mobile and cloud computing to objectively assess and provide information to patients and providers around medication adherence and disease control in pediatric asthma. The information will then be loaded to phone app.~All data in the table represent values collected during the study and no placeholder values were used."
23320|NCT02517047|O1|Outcome|CareTRx Device|"All eligible participants will receive CareTRx device for control inhaler as well as the application downloaded to their Android phone. CareTRx is a novel monitoring device that can be applied to most MDI (meter dose inhaler) device and leverages mobile and cloud computing to objectively assess and provide information to patients and providers around medication adherence and disease control in pediatric asthma. The information will then be loaded to phone app.~All data in the table represent values collected during the study and no placeholder values were used."
23321|NCT02517047|E1|Reported Event|CareTRx Device|"Subject will receive CareTRx device for rescue inhaler as well as the application downloaded to their Android phone. The device will track when the rescue inhaler is administered. The information will then be loaded to phone app.~CareTRx: CareTRx is a novel device that can be applied to most MDI (meter dose inhaler) device and leverages mobile and cloud computing to objectively assess and provide real-visualize feedback to patients and providers around medication adherence and disease control in pediatric asthma."
23322|NCT02516306|B3|Baseline|Total|Total of all reporting groups
24818|NCT02498652|O5|Outcome|Treatment R2|Allopurinol 300 mg qd + RDEA3170 5 mg qd (Cohort 2)
23323|NCT02516306|B2|Baseline|Placebo|Placebo Ophthalmic Solution: Period 1 (Day 1 - 7) one drop in one eye twice per day for 7 days; Period 2 (Day 8 - 91) one drop in both eyes twice per day for 84 days.
23324|NCT02516306|B1|Baseline|EV06 Ophthalmic Solution|EV06 Ophthalmic Solution: Period 1 (Day 1 - 7) one drop in one eye twice per day for 7 days; Period 2 (Day 8 - 91) one drop in both eyes twice per day for 84 days.
23325|NCT02516306|P2|Participant Flow|Placebo|Placebo Ophthalmic Solution: Day 1 - 7 one drop twice per day in one eye. Day 8 - 91 one drop administered twice per day in both eyes.
23326|NCT02516306|P1|Participant Flow|EVO6 Ophthalmic Solution|EV06 Ophthalmic Solution: Day 1 - 7 one drop twice per day in one eye; Day 8 - 91 one drop twice per day in both eyes.
23327|NCT02516306|O2|Outcome|Placebo Ophthalmic Solution|Placebo Ophthalmic Solution: Period 1 (Day 1 - 7) one drop twice per day in one eye; Period 2 (Day 8 - 91) one drop twice per day in both eyes.
23328|NCT02516306|O1|Outcome|EVO6 Ophthalmic Solution|EV06 Ophthalmic Solution: Period 1 (Day 1 - 7) one drop twice per day in one eye; Period 2 (Day 8 - 91) one drop twice per day in both eyes.
23329|NCT02516306|E2|Reported Event|Placebo|Placebo Ophthalmic Solution: Period 1 (Day 1 - 7) one drop twice per day to one eye; Period 2 (Day 8 - 91) one drop twice per day to both eyes.
23330|NCT02516306|E1|Reported Event|EVO6|EV06 Ophthalmic Solution: Period 1 (Day 1 - 7) one drop twice per day to one eye; Period 2 (Day 8 - 91) one drop twice per day to both eyes.
23331|NCT02516163|B1|Baseline|Shapematch Cutting Guides|"The ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting.~They are intended for single use only."
23332|NCT02516163|P1|Participant Flow|Shapematch Cutting Guides|The ShapeMatch® Cutting Guides are patient-specific surgical instruments to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting.They are single use only. Participants undergo pre-operative assessment using MRI of the affected limb. At the time of surgery, a repeated-measures methodology is implemented in which the position of the femoral and tibial cutting guides is measured using the Navigation system. The same surgeon will position each cutting guide a total of 3 times for each patient. No bone cuts will take place using the patient-specific cutting guides. After the study-specific measurements have been taken, the total knee procedure will resume using the Navigation system and instruments. No post-operative evaluations will be undertaken as part of this sub-study.
23333|NCT02516163|O1|Outcome|Shapematch Cutting Guides|"The ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting.~They are intended for single use only."
23334|NCT02516163|E1|Reported Event|Shapematch Cutting Guides|"The ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting.~They are intended for single use only.~Shapematch Cutting Guides: Participants will undergo pre-operative assessment using MRI of the affected limb. At the time of surgery, a repeated-measures methodology will be implemented in which the position of the femoral and tibial cutting guides will be measured using the Navigation system. The same surgeon will position each cutting guide a total of 3 times for each patient. Multiple participants will be assessed by each surgeon. No bone cuts will take place using the patient-specific cutting guides. After the study-specific measurements have been taken, the total knee procedure will resume using the Navigation system instruments. No post-operative evaluations will be undertaken as part of this sub-study"
23335|NCT02516150|B1|Baseline|All Subjects|All subjects enrolled
23336|NCT02516150|P1|Participant Flow|All Subjects|All subjects enrolled
23337|NCT02516150|O2|Outcome|Glucagon Without Ethanol|"Volunteers will not receive an infusion of IV ethanol at this visit. 50 micrograms of glucagon will be administered via subcutaneous injection.~Glucagon: injection of 50 micrograms of glucagon"
23338|NCT02516150|O1|Outcome|Glucagon With Ethanol|"Volunteers will receive an infusion of IV ethanol that will increase their BAC (blood alcohol content) to 0.1. Once their BAC has stabilized at 0.1%, 50 micrograms of glucagon will be administered via subcutaneous injection.~Ethanol: IV infusion of ethanol to stabilize BAC (blood alcohol content) at 0.1%~Glucagon: injection of 50 micrograms of glucagon"
23339|NCT02516150|O2|Outcome|Glucagon Without Ethanol|"Volunteers will not receive an infusion of IV ethanol at this visit. 50 micrograms of glucagon will be administered via subcutaneous injection.~Glucagon: injection of 50 micrograms of glucagon"
23340|NCT02516150|O1|Outcome|Glucagon With Ethanol|"Volunteers will receive an infusion of IV ethanol that will increase their BAC (blood alcohol content) to 0.1. Once their BAC has stabilized at 0.1%, 50 micrograms of glucagon will be administered via subcutaneous injection.~Ethanol: IV infusion of ethanol to stabilize BAC (blood alcohol content) at 0.1%~Glucagon: injection of 50 micrograms of glucagon"
23341|NCT02516150|E2|Reported Event|Glucagon Without Ethanol|"Volunteers will not receive an infusion of IV ethanol at this visit. 50 micrograms of glucagon will be administered via subcutaneous injection.~Glucagon: injection of 50 micrograms of glucagon"
23342|NCT02516150|E1|Reported Event|Glucagon With Ethanol|"Volunteers will receive an infusion of IV ethanol that will increase their BAC (blood alcohol content) to 0.1. Once their BAC has stabilized at 0.1%, 50 micrograms of glucagon will be administered via subcutaneous injection.~Ethanol: IV infusion of ethanol to stabilize BAC (blood alcohol content) at 0.1%~Glucagon: injection of 50 micrograms of glucagon"
23343|NCT02516098|B3|Baseline|Total|Total of all reporting groups
23344|NCT02516098|B2|Baseline|T-REF|"The subjects received test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) followed by a washout period of 7 to 14 days followed by the reference treatment (REF) which was 20 mg of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) followed by a washout period of 7 to 14 days.~All medications were administered as a single oral dose in the fasted state via a sugar coated tablet."
23345|NCT02516098|B1|Baseline|REF-T|"The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) followed by a washout period of 7 to 14 days followed by the test treatment (T) which was 20 mg of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) followed by a washout period of 7 to 14 days.~All medications were administered as a single oral dose in the fasted state via a sugar coated tablet."
24901|NCT02497976|B2|Baseline|Placebo|Normal saline
23346|NCT02516098|P2|Participant Flow|T-REF|"The subjects received test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) followed by a washout period of 7 to 14 days followed by the reference treatment (REF) which was 20 mg of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) followed by a washout period of 7 to 14 days.~All medications were administered as a single oral dose in the fasted state via a sugar coated tablet."
23347|NCT02516098|P1|Participant Flow|REF-T|"The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) followed by a washout period of 7 to 14 days followed by the test treatment (T) which was 20 mg of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) followed by a washout period of 7 to 14 days.~All medications were administered as a single oral dose in the fasted state via a sugar coated tablet."
23348|NCT02516098|O2|Outcome|Buscapina® (T)|The subjects received the test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet
23349|NCT02516098|O1|Outcome|Buscopan® (REF)|The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet.
23350|NCT02516098|O2|Outcome|Buscapina® (T)|The subjects received the test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet
23351|NCT02516098|O1|Outcome|Buscopan® (REF)|The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet.
23352|NCT02516098|O2|Outcome|Buscapina® (T)|The subjects received the test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet
23353|NCT02516098|O1|Outcome|Buscopan® (REF)|The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet.
23354|NCT02516098|O2|Outcome|Buscapina® (T)|The subjects received the test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet
23355|NCT02516098|O1|Outcome|Buscopan® (REF)|The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet.
23356|NCT02516098|E2|Reported Event|Buscapina® (T)|The subjects received the test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet
23357|NCT02516098|E1|Reported Event|Buscopan® (REF)|The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet.
23358|NCT02515994|B3|Baseline|Total|Total of all reporting groups
23359|NCT02515994|B2|Baseline|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
23360|NCT02515994|B1|Baseline|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
23361|NCT02515994|P2|Participant Flow|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
23362|NCT02515994|P1|Participant Flow|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
23363|NCT02515994|O2|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire study.
23364|NCT02515994|O1|Outcome|Senofilcon C|Subjects that wore the senofilcon C lens throughout the entire study.
23365|NCT02515994|O2|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire study.
23366|NCT02515994|O1|Outcome|Senofilcon C|Subjects that wore the senofilcon C lens throughout the entire study.
23367|NCT02515994|O2|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire study.
23368|NCT02515994|O1|Outcome|Senofilcon C|Subjects that wore the senofilcon C lens throughout the entire study.
23369|NCT02515994|O2|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire study.
23370|NCT02515994|O1|Outcome|Senofilcon C|Subjects that wore the senofilcon C lens throughout the entire study.
23371|NCT02515994|E2|Reported Event|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
23372|NCT02515994|E1|Reported Event|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
23373|NCT02515851|B3|Baseline|Total|Total of all reporting groups
23374|NCT02515851|B2|Baseline|Placebo Group|"Group that receives placebo injections~Placebo"
23375|NCT02515851|B1|Baseline|Active Group|"Group that receives actual liposomal bupivacaine injections~Exparel"
23376|NCT02515851|P2|Participant Flow|Placebo Group|"Group that receives placebo injections~Placebo"
23377|NCT02515851|P1|Participant Flow|Active Group|"Group that receives actual liposomal bupivacaine injections~Exparel"
23378|NCT02515851|O2|Outcome|Placebo Group|"Group that receives placebo injections~Placebo"
23379|NCT02515851|O1|Outcome|Active Group|"Group that receives actual liposomal bupivacaine injections~Exparel"
23380|NCT02515851|O2|Outcome|Placebo Group|"Group that receives placebo injections~Placebo"
23381|NCT02515851|O1|Outcome|Active Group|"Group that receives actual liposomal bupivacaine injections~Exparel"
23382|NCT02515851|O2|Outcome|Placebo Group|"Group that receives placebo injections~Placebo"
23383|NCT02515851|O1|Outcome|Active Group|"Group that receives actual liposomal bupivacaine injections~Exparel"
23384|NCT02515851|O2|Outcome|Placebo Group|"Group that receives placebo injections~Placebo"
23385|NCT02515851|O1|Outcome|Active Group|"Group that receives actual liposomal bupivacaine injections~Exparel"
23386|NCT02515851|E2|Reported Event|Placebo Group|"Group that receives placebo injections~Placebo"
23388|NCT02515279|B1|Baseline|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
23389|NCT02515279|P1|Participant Flow|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
23390|NCT02515279|O1|Outcome|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
23391|NCT02515279|O1|Outcome|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
23392|NCT02515279|O1|Outcome|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
23393|NCT02515279|E1|Reported Event|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
23394|NCT02515058|B3|Baseline|Total|Total of all reporting groups
23395|NCT02515058|B2|Baseline|Freeze-Dried Bone Allograft (FDBA)|"Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA)~FDBA (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction"
23396|NCT02515058|B1|Baseline|Non-Freeze-Dried Bone Allograft (PUROS)|"Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS)~PUROS (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction"
23397|NCT02515058|P2|Participant Flow|Freeze-Dried Bone Allograft (FDBA)|"Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA)~FDBA (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction"
23398|NCT02515058|P1|Participant Flow|Non-Freeze-Dried Bone Allograft (PUROS)|"Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS)~PUROS (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction"
23399|NCT02515058|O2|Outcome|Freeze-Dried Bone Allograft (FDBA)|"Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA)~FDBA (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction"
23400|NCT02515058|O1|Outcome|Non-Freeze-Dried Bone Allograft (PUROS)|"Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS)~PUROS (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction"
23401|NCT02515058|O2|Outcome|Freeze-Dried Bone Allograft (FDBA)|"Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA)~FDBA (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction"
23402|NCT02515058|O1|Outcome|Non-Freeze-Dried Bone Allograft (PUROS)|"Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS)~PUROS (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction"
23403|NCT02515058|E2|Reported Event|Freeze-Dried Bone Allograft (FDBA)|"Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA)~FDBA (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction"
23404|NCT02515058|E1|Reported Event|Non-Freeze-Dried Bone Allograft (PUROS)|"Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS)~PUROS (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction"
23405|NCT02515045|B3|Baseline|Total|Total of all reporting groups
23406|NCT02515045|B2|Baseline|TriMoxiVanc + Ilevro One Eye + Control Fellow Eye|"Subject's eyes were randomized to either TriMoxiVan + Ilevro or Control group.~TriMoxiVan + Ilevro group:~Nepafenac ophthalmic suspension 0.3% started 3 days prior to surgery QD and continued QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco (triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml ) injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.~Control group:~Moxifloxacin HCl 0.5%: 1 drop, QID for 3 days prior to surgery and continued for 2 weeks after surgery and then discontinued.~Ilevro (Nepafenac ophthalmic suspension 0.3%): 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.~Prednisolone acetate 1%: Started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued."
23474|NCT02514473|O1|Outcome|Placebo|Participants received placebo matched to LUM in combination with IVA FDC tablets orally q12h for 24 weeks.
23475|NCT02514473|O2|Outcome|LUM/IVA|Participants received LUM 200 mg in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
23407|NCT02515045|B1|Baseline|TriMoxiVanc One Eye + Control Fellow Eye|"Subject's eyes were randomized to either TriMoxiVan or Control group.~TriMoxiVanc group:~Triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml used as an injection delivered into the vitreous cavity using a transzonular approach at the end of the uneventful phacoemulsification procedure after IOL implantation before removal of the OVD.~Control group:~Moxifloxacin HCl 0.5%: 1 drop, QID for 3 days prior to surgery and continued for 2 weeks after surgery and then discontinued.~Ilevro (Nepafenac ophthalmic suspension 0.3%): 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.~Prednisolone acetate 1%: Started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued."
23408|NCT02515045|P3|Participant Flow|Control|"Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.~Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.~Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.~Moxifloxacin HCl 0.5%: Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.~Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.~Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued."
23409|NCT02515045|P2|Participant Flow|TriMoxiVanc + Ilevro|"Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.~TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.~Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery."
23410|NCT02515045|P1|Participant Flow|TriMoxiVanc|"The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.~TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery."
23411|NCT02515045|O3|Outcome|Control|"Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.~Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.~Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.~Moxifloxacin HCl 0.5%: Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.~Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.~Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued."
23412|NCT02515045|O2|Outcome|TriMoxiVanc + Ilevro|"Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.~TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.~Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery."
23413|NCT02515045|O1|Outcome|TriMoxiVanc|"The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.~TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery."
23414|NCT02515045|O3|Outcome|Control|"Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.~Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.~Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.~Moxifloxacin HCl 0.5%: Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.~Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.~Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued."
23415|NCT02515045|O2|Outcome|TriMoxiVanc + Ilevro|"Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.~TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.~Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery."
23416|NCT02515045|O1|Outcome|TriMoxiVanc|"The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.~TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery."
23417|NCT02515045|O3|Outcome|Control|"Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.~Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.~Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.~Moxifloxacin HCl 0.5%: Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.~Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.~Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued."
23476|NCT02514473|O1|Outcome|Placebo|Participants received placebo matched to LUM in combination with IVA FDC tablets orally q12h for 24 weeks.
23477|NCT02514473|O2|Outcome|LUM/IVA|Participants received LUM 200 mg in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
23478|NCT02514473|O1|Outcome|Placebo|Participants received placebo matched to LUM in combination with IVA FDC tablets orally q12h for 24 weeks.
23418|NCT02515045|O2|Outcome|TriMoxiVanc + Ilevro|"Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.~TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.~Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery."
23419|NCT02515045|O1|Outcome|TriMoxiVanc|"The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.~TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery."
23420|NCT02515045|E3|Reported Event|Control|"Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.~Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.~Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.~Moxifloxacin HCl 0.5%: Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.~Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.~Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued."
23421|NCT02515045|E2|Reported Event|TriMoxiVanc + Ilevro|"Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.~TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.~Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery."
23422|NCT02515045|E1|Reported Event|TriMoxiVanc|"The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.~TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery."
23423|NCT02514889|B3|Baseline|Total|Total of all reporting groups
23424|NCT02514889|B2|Baseline|Calorie-counting|"Intervention protocol adapted from Diabetes Prevention Program lifestyle change intervention.~Calorie-counting: The Calorie Counting (CC) condition asks obese patients to achieve a daily calorie deficit. For average women consuming 2,000 calories at baseline, the target daily calorie total might be 1,600 calories. Participants are also asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the CC condition. The intervention protocol is adapted from the Diabetes Prevention Program. Behavior change strategies include: self-monitoring (e.g., calorie-counting, self-weighing), stimulus control, and relapse prevention strategies. The health coaching will occur during two home visits, two group health education sessions, and 7 telephone coaching calls."
23425|NCT02514889|B1|Baseline|MyPlate|"Intervention protocol adapted from Dietary Approaches to Stop Hypertension dietary pattern.~MyPlate: The MyPlate approach asks Americans to limit daily calories but emphasizes eating MORE high-satiation foods by making ½ of daily food choices fruits and vegetables,¼ of daily food choices whole grains. All participants are asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the MyPlate condition. MyPlate is adapted from the DASH protocol. Behavior change strategies include: progressive goal-setting, stimulus control, and self-monitoring (e.g., % of food choices that are fruits & vegetables). The health coaching will occur during two home visits, two group health education sessions, and 7 telephone behavior change coaching calls."
23426|NCT02514889|P2|Participant Flow|Calorie-counting|"Intervention protocol adapted from Diabetes Prevention Program lifestyle change intervention.~Calorie-counting: The Calorie Counting (CC) condition asks obese patients to achieve a daily calorie deficit. For average women consuming 2,000 calories at baseline, the target daily calorie total might be 1,600 calories. Participants are also asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the CC condition. The intervention protocol is adapted from the Diabetes Prevention Program. Behavior change strategies include: self-monitoring (e.g., calorie-counting, self-weighing), stimulus control, and relapse prevention strategies. The health coaching will occur during two home visits, two group health education sessions, and 7 telephone coaching calls."
23427|NCT02514889|P1|Participant Flow|MyPlate|"Intervention protocol adapted from Dietary Approaches to Stop Hypertension dietary pattern.~MyPlate: The MyPlate approach asks Americans to limit daily calories but emphasizes eating MORE high-satiation foods by making ½ of daily food choices fruits and vegetables,¼ of daily food choices whole grains. All participants are asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the MyPlate condition. MyPlate is adapted from the DASH protocol. Behavior change strategies include: progressive goal-setting, stimulus control, and self-monitoring (e.g., % of food choices that are fruits & vegetables). The health coaching will occur during two home visits, two group health education sessions, and 7 telephone behavior change coaching calls."
23428|NCT02514889|O2|Outcome|Calorie-counting|"Intervention protocol adapted from Diabetes Prevention Program lifestyle change intervention.~Calorie-counting: The Calorie Counting (CC) condition asks obese patients to achieve a daily calorie deficit. For average women consuming 2,000 calories at baseline, the target daily calorie total might be 1,600 calories. Participants are also asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the CC condition. The intervention protocol is adapted from the Diabetes Prevention Program. Behavior change strategies include: self-monitoring (e.g., calorie-counting, self-weighing), stimulus control, and relapse prevention strategies. The health coaching will occur during two home visits, two group health education sessions, and 7 telephone coaching calls."
23429|NCT02514889|O1|Outcome|MyPlate|"Intervention protocol adapted from Dietary Approaches to Stop Hypertension dietary pattern.~MyPlate: The MyPlate approach asks Americans to limit daily calories but emphasizes eating MORE high-satiation foods by making ½ of daily food choices fruits and vegetables,¼ of daily food choices whole grains. All participants are asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the MyPlate condition. MyPlate is adapted from the DASH protocol. Behavior change strategies include: progressive goal-setting, stimulus control, and self-monitoring (e.g., % of food choices that are fruits & vegetables). The health coaching will occur during two home visits, two group health education sessions, and 7 telephone behavior change coaching calls."
23430|NCT02514889|O2|Outcome|Calorie-counting|"Intervention protocol adapted from Diabetes Prevention Program lifestyle change intervention.~Calorie-counting: The Calorie Counting (CC) condition asks obese patients to achieve a daily calorie deficit. For average women consuming 2,000 calories at baseline, the target daily calorie total might be 1,600 calories. Participants are also asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the CC condition. The intervention protocol is adapted from the Diabetes Prevention Program. Behavior change strategies include: self-monitoring (e.g., calorie-counting, self-weighing), stimulus control, and relapse prevention strategies. The health coaching will occur during two home visits, two group health education sessions, and 7 telephone coaching calls."
23431|NCT02514889|O1|Outcome|MyPlate|"Intervention protocol adapted from Dietary Approaches to Stop Hypertension dietary pattern.~MyPlate: The MyPlate approach asks Americans to limit daily calories but emphasizes eating MORE high-satiation foods by making ½ of daily food choices fruits and vegetables,¼ of daily food choices whole grains. All participants are asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the MyPlate condition. MyPlate is adapted from the DASH protocol. Behavior change strategies include: progressive goal-setting, stimulus control, and self-monitoring (e.g., % of food choices that are fruits & vegetables). The health coaching will occur during two home visits, two group health education sessions, and 7 telephone behavior change coaching calls."
23432|NCT02514889|O2|Outcome|Calorie-counting|"Intervention protocol adapted from Diabetes Prevention Program lifestyle change intervention.~Calorie-counting: The Calorie Counting (CC) condition asks obese patients to achieve a daily calorie deficit. For average women consuming 2,000 calories at baseline, the target daily calorie total might be 1,600 calories. Participants are also asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the CC condition. The intervention protocol is adapted from the Diabetes Prevention Program. Behavior change strategies include: self-monitoring (e.g., calorie-counting, self-weighing), stimulus control, and relapse prevention strategies. The health coaching will occur during two home visits, two group health education sessions, and 7 telephone coaching calls."
23433|NCT02514889|O1|Outcome|MyPlate|"Intervention protocol adapted from Dietary Approaches to Stop Hypertension dietary pattern.~MyPlate: The MyPlate approach asks Americans to limit daily calories but emphasizes eating MORE high-satiation foods by making ½ of daily food choices fruits and vegetables,¼ of daily food choices whole grains. All participants are asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the MyPlate condition. MyPlate is adapted from the DASH protocol. Behavior change strategies include: progressive goal-setting, stimulus control, and self-monitoring (e.g., % of food choices that are fruits & vegetables). The health coaching will occur during two home visits, two group health education sessions, and 7 telephone behavior change coaching calls."
23434|NCT02514889|O2|Outcome|Calorie-counting|"Intervention protocol adapted from Diabetes Prevention Program lifestyle change intervention.~Calorie-counting: The Calorie Counting (CC) condition asks obese patients to achieve a daily calorie deficit. For average women consuming 2,000 calories at baseline, the target daily calorie total might be 1,600 calories. Participants are also asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the CC condition. The intervention protocol is adapted from the Diabetes Prevention Program. Behavior change strategies include: self-monitoring (e.g., calorie-counting, self-weighing), stimulus control, and relapse prevention strategies. The health coaching will occur during two home visits, two group health education sessions, and 7 telephone coaching calls."
23435|NCT02514889|O1|Outcome|MyPlate|"Intervention protocol adapted from Dietary Approaches to Stop Hypertension dietary pattern.~MyPlate: The MyPlate approach asks Americans to limit daily calories but emphasizes eating MORE high-satiation foods by making ½ of daily food choices fruits and vegetables,¼ of daily food choices whole grains. All participants are asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the MyPlate condition. MyPlate is adapted from the DASH protocol. Behavior change strategies include: progressive goal-setting, stimulus control, and self-monitoring (e.g., % of food choices that are fruits & vegetables). The health coaching will occur during two home visits, two group health education sessions, and 7 telephone behavior change coaching calls."
23436|NCT02514889|O2|Outcome|Calorie-counting|"Intervention protocol adapted from Diabetes Prevention Program lifestyle change intervention.~Calorie-counting: The Calorie Counting (CC) condition asks obese patients to achieve a daily calorie deficit. For average women consuming 2,000 calories at baseline, the target daily calorie total might be 1,600 calories. Participants are also asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the CC condition. The intervention protocol is adapted from the Diabetes Prevention Program. Behavior change strategies include: self-monitoring (e.g., calorie-counting, self-weighing), stimulus control, and relapse prevention strategies. The health coaching will occur during two home visits, two group health education sessions, and 7 telephone coaching calls."
23479|NCT02514473|O2|Outcome|LUM/IVA|Participants received LUM 200 mg in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
23480|NCT02514473|O1|Outcome|Placebo|Participants received placebo matched to LUM in combination with IVA FDC tablets orally q12h for 24 weeks.
23437|NCT02514889|O1|Outcome|MyPlate|"Intervention protocol adapted from Dietary Approaches to Stop Hypertension dietary pattern.~MyPlate: The MyPlate approach asks Americans to limit daily calories but emphasizes eating MORE high-satiation foods by making ½ of daily food choices fruits and vegetables,¼ of daily food choices whole grains. All participants are asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the MyPlate condition. MyPlate is adapted from the DASH protocol. Behavior change strategies include: progressive goal-setting, stimulus control, and self-monitoring (e.g., % of food choices that are fruits & vegetables). The health coaching will occur during two home visits, two group health education sessions, and 7 telephone behavior change coaching calls."
23438|NCT02514889|O2|Outcome|Calorie-counting|"Intervention protocol adapted from Diabetes Prevention Program lifestyle change intervention.~Calorie-counting: The Calorie Counting (CC) condition asks obese patients to achieve a daily calorie deficit. For average women consuming 2,000 calories at baseline, the target daily calorie total might be 1,600 calories. Participants are also asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the CC condition. The intervention protocol is adapted from the Diabetes Prevention Program. Behavior change strategies include: self-monitoring (e.g., calorie-counting, self-weighing), stimulus control, and relapse prevention strategies. The health coaching will occur during two home visits, two group health education sessions, and 7 telephone coaching calls."
23439|NCT02514889|O1|Outcome|MyPlate|"Intervention protocol adapted from Dietary Approaches to Stop Hypertension dietary pattern.~MyPlate: The MyPlate approach asks Americans to limit daily calories but emphasizes eating MORE high-satiation foods by making ½ of daily food choices fruits and vegetables,¼ of daily food choices whole grains. All participants are asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the MyPlate condition. MyPlate is adapted from the DASH protocol. Behavior change strategies include: progressive goal-setting, stimulus control, and self-monitoring (e.g., % of food choices that are fruits & vegetables). The health coaching will occur during two home visits, two group health education sessions, and 7 telephone behavior change coaching calls."
23440|NCT02514889|O2|Outcome|Calorie-counting|"Intervention protocol adapted from Diabetes Prevention Program lifestyle change intervention.~Calorie-counting: The Calorie Counting (CC) condition asks obese patients to achieve a daily calorie deficit. For average women consuming 2,000 calories at baseline, the target daily calorie total might be 1,600 calories. Participants are also asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the CC condition. The intervention protocol is adapted from the Diabetes Prevention Program. Behavior change strategies include: self-monitoring (e.g., calorie-counting, self-weighing), stimulus control, and relapse prevention strategies. The health coaching will occur during two home visits, two group health education sessions, and 7 telephone coaching calls."
23441|NCT02514889|O1|Outcome|MyPlate|"Intervention protocol adapted from Dietary Approaches to Stop Hypertension dietary pattern.~MyPlate: The MyPlate approach asks Americans to limit daily calories but emphasizes eating MORE high-satiation foods by making ½ of daily food choices fruits and vegetables,¼ of daily food choices whole grains. All participants are asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the MyPlate condition. MyPlate is adapted from the DASH protocol. Behavior change strategies include: progressive goal-setting, stimulus control, and self-monitoring (e.g., % of food choices that are fruits & vegetables). The health coaching will occur during two home visits, two group health education sessions, and 7 telephone behavior change coaching calls."
23442|NCT02514889|E2|Reported Event|MyPlate|"Intervention protocol adapted from Dietary Approaches to Stop Hypertension dietary pattern.~MyPlate: The MyPlate approach asks Americans to limit daily calories but emphasizes eating MORE high-satiation foods by making ½ of daily food choices fruits and vegetables,¼ of daily food choices whole grains. All participants are asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the MyPlate condition. MyPlate is adapted from the DASH protocol. Behavior change strategies include: progressive goal-setting, stimulus control, and self-monitoring (e.g., % of food choices that are fruits & vegetables). The health coaching will occur during two home visits, two group health education sessions, and 7 telephone behavior change coaching calls."
23443|NCT02514889|E1|Reported Event|Calorie-counting|"Intervention protocol adapted from Diabetes Prevention Program lifestyle change intervention.~Calorie-counting: The Calorie Counting (CC) condition asks obese patients to achieve a daily calorie deficit. For average women consuming 2,000 calories at baseline, the target daily calorie total might be 1,600 calories. Participants are also asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the CC condition. The intervention protocol is adapted from the Diabetes Prevention Program. Behavior change strategies include: self-monitoring (e.g., calorie-counting, self-weighing), stimulus control, and relapse prevention strategies. The health coaching will occur during two home visits, two group health education sessions, and 7 telephone coaching calls."
23444|NCT02514772|B3|Baseline|Total|Total of all reporting groups
23445|NCT02514772|B2|Baseline|Rituxan ® / MabThera ®|"10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v.~Originator rituximab - Rituxan ® or MabThera ® dependent on region of participation (USA patients receive Rituxan; EU patients receive MabThera)"
23446|NCT02514772|B1|Baseline|GP2013|"10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration, two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v.~GP2013 - A Proposed biosimilar rituximab"
23481|NCT02514473|O2|Outcome|LUM/IVA|Participants received LUM 200 mg in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
23482|NCT02514473|O1|Outcome|Placebo|Participants received placebo matched to LUM in combination with IVA FDC tablets orally q12h for 24 weeks.
23483|NCT02514473|O2|Outcome|LUM/IVA|Participants received LUM 200 mg in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
23447|NCT02514772|P2|Participant Flow|Rituxan® / MabThera®|"10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v. The treatment course consists of 2 i.v. infusions 2 weeks apart (at Day 1 and Day 14)~Originator rituximab - Rituxan ® or MabThera ® dependent on region of participation (USA patients receive Rituxan; EU patients receive MabThera).~Patients in this group receive same originator rituximab as they received before study participation"
23448|NCT02514772|P1|Participant Flow|GP2013|"10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration, two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v. The treatment course consists of 2 i.v. infusions 2 weeks apart (at Day 1 and Day 14)~GP2013 - A proposed biosimilar rituximab~Patients in this group are switched from originator rituximab (which they received before study participation) to GP2013"
23449|NCT02514772|O2|Outcome|Rituxan ® / MabThera ®|"10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v.~Originator rituximab - Rituxan ® or MabThera ® dependent on region of participation (USA patients receive Rituxan; EU patients receive MabThera)"
23450|NCT02514772|O1|Outcome|GP2013|"10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration, two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v.~GP2013 - A Proposed biosimilar rituximab"
23451|NCT02514772|O2|Outcome|Rituxan® / MabThera®|"10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v.~Originator rituximab - Rituxan ® or MabThera ® dependent on region of participation (USA patients receive Rituxan; EU patients receive MabThera).~Patients in this group receive same originator rituximab as they received before study participation"
23452|NCT02514772|O1|Outcome|GP2013|"10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration, two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v.~GP2013 - A proposed biosimilar rituximab~Patients in this group are switched from originator rituximab (which they received before study participation) to GP2013"
23453|NCT02514772|O2|Outcome|Rituxan® / MabThera®|"10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v.~Originator rituximab - Rituxan ® or MabThera ® dependent on region of participation (USA patients receive Rituxan; EU patients receive MabThera).~Patients in this group receive same originator rituximab as they received before study participation"
23454|NCT02514772|O1|Outcome|GP2013|"10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration, two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v.~GP2013 - A proposed biosimilar rituximab~Patients in this group are switched from originator rituximab (which they received before study participation) to GP2013"
23455|NCT02514772|O2|Outcome|Rituxan® / MabThera®|"10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v.~Originator rituximab - Rituxan ® or MabThera ® dependent on region of participation (USA patients receive Rituxan; EU patients receive MabThera).~Patients in this group receive same originator rituximab as they received before study participation"
23456|NCT02514772|O1|Outcome|GP2013|"10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration, two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v.~GP2013 - A proposed biosimilar rituximab~Patients in this group are switched from originator rituximab (which they received before study participation) to GP2013"
23457|NCT02514772|E2|Reported Event|Rituxan® / MabThera®|"10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v.~Originator rituximab - Rituxan ® or MabThera ® dependent on region of participation (USA patients receive Rituxan; EU patients receive MabThera).~Patients in this group receive same originator rituximab as they received before study participation"
23458|NCT02514772|E1|Reported Event|GP2013|"10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration, two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v.~GP2013 - A proposed biosimilar rituximab~Patients in this group are switched from originator rituximab (which they received before study participation) to GP2013"
23459|NCT02514473|B3|Baseline|Total|Total of all reporting groups
23460|NCT02514473|B2|Baseline|LUM/IVA|Participants received LUM 200 mg in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
23461|NCT02514473|B1|Baseline|Placebo|Participants received placebo matched to LUM in combination with IVA FDC tablets orally q12h for 24 weeks.
23462|NCT02514473|P2|Participant Flow|LUM/IVA|Participants received LUM 200 milligram (mg) in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
23463|NCT02514473|P1|Participant Flow|Placebo|Participants received placebo matched to LUM in combination with IVA fixed-dose combination (FDC) tablets orally every 12 hours (q12h) for 24 weeks.
23464|NCT02514473|O1|Outcome|LUM/IVA|Participants received LUM 200 mg in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
23465|NCT02514473|O2|Outcome|LUM/IVA|Participants received LUM 200 mg in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
23466|NCT02514473|O1|Outcome|Placebo|Participants received placebo matched to LUM in combination with IVA FDC tablets orally q12h for 24 weeks.
23467|NCT02514473|O2|Outcome|LUM/IVA|Participants received LUM 200 mg in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
23468|NCT02514473|O1|Outcome|Placebo|Participants received placebo matched to LUM in combination with IVA FDC tablets orally q12h for 24 weeks.
23469|NCT02514473|O2|Outcome|LUM/IVA|Participants received LUM 200 mg in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
23470|NCT02514473|O1|Outcome|Placebo|Participants received placebo matched to LUM in combination with IVA FDC tablets orally q12h for 24 weeks.
23471|NCT02514473|O2|Outcome|LUM/IVA|Participants received LUM 200 mg in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
23472|NCT02514473|O1|Outcome|Placebo|Participants received placebo matched to LUM in combination with IVA FDC tablets orally q12h for 24 weeks.
23473|NCT02514473|O2|Outcome|LUM/IVA|Participants received LUM 200 mg in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
23485|NCT02514473|O2|Outcome|LUM/IVA|Participants received LUM 200 mg in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
23486|NCT02514473|O1|Outcome|Placebo|Participants received placebo matched to LUM in combination with IVA FDC tablets orally q12h for 24 weeks.
23487|NCT02514473|O2|Outcome|LUM/IVA|Participants received LUM 200 mg in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
23488|NCT02514473|O1|Outcome|Placebo|Participants received placebo matched to LUM in combination with IVA FDC tablets orally q12h for 24 weeks.
23489|NCT02514473|O2|Outcome|LUM/IVA|Participants received LUM 200 mg in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
23490|NCT02514473|O1|Outcome|Placebo|Participants received placebo matched to LUM in combination with IVA FDC tablets orally q12h for 24 weeks.
23491|NCT02514473|O2|Outcome|LUM/IVA|Participants received LUM 200 mg in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
23492|NCT02514473|O1|Outcome|Placebo|Participants received placebo matched to LUM in combination with IVA FDC tablets orally q12h for 24 weeks.
23493|NCT02514473|O2|Outcome|LUM/IVA|Participants received LUM 200 mg in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
23494|NCT02514473|O1|Outcome|Placebo|Participants received placebo matched to LUM in combination with IVA FDC tablets orally q12h for 24 weeks.
23495|NCT02514473|O2|Outcome|LUM/IVA|Participants received LUM 200 mg in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
23496|NCT02514473|O1|Outcome|Placebo|Participants received placebo matched to LUM in combination with IVA FDC tablets orally q12h for 24 weeks.
23497|NCT02514473|O2|Outcome|LUM/IVA|Participants received LUM 200 mg in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
23498|NCT02514473|O1|Outcome|Placebo|Participants received placebo matched to LUM in combination with IVA FDC tablets orally q12h for 24 weeks.
23499|NCT02514473|O2|Outcome|LUM/IVA|Participants received LUM 200 mg in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
23500|NCT02514473|O1|Outcome|Placebo|Participants received placebo matched to LUM in combination with IVA FDC tablets orally q12h for 24 weeks.
23501|NCT02514473|E2|Reported Event|LUM/IVA|Participants received LUM 200 mg in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
23502|NCT02514473|E1|Reported Event|Placebo|Participants received placebo matched to LUM in combination with IVA FDC tablets orally q12h for 24 weeks.
23503|NCT02513771|B3|Baseline|Total|Total of all reporting groups
23504|NCT02513771|B2|Baseline|Placebo Arm|Placebo for sitagliptin: One tablet taken orally daily for 16 weeks, followed by a 4-week post-treatment follow-up.
23505|NCT02513771|B1|Baseline|Sitagliptin Arm|Sitagliptin: 100 mg one tablet taken orally daily for 16 weeks, followed by a 4-week post-treatment follow-up
23506|NCT02513771|P2|Participant Flow|Placebo Arm|Placebo for sitagliptin one tablet daily p.o.for 16 weeks, followed by a 4-week post-treatment follow-up.
23507|NCT02513771|P1|Participant Flow|Sitagliptin Arm|Sitagliptin (Januvia) 100 mg one tablet daily p.o. for 16 weeks, followed by a 4-week post-treatment follow-up.
23508|NCT02513771|O2|Outcome|Placebo Arm|Placebo for sitagliptin one tablet daily p.o.for 16 weeks, followed by a 4-week post-treatment follow-up.
23509|NCT02513771|O1|Outcome|Sitagliptin Arm|Sitagliptin (Januvia) 100 mg one tablet daily p.o. for 16 weeks, followed by a 4-week post-treatment follow-up.
23510|NCT02513771|O2|Outcome|Placebo Arm|Placebo for sitagliptin one tablet daily p.o.for 16 weeks, followed by a 4-week post-treatment follow-up.
23511|NCT02513771|O1|Outcome|Sitagliptin Arm|Sitagliptin (Januvia) 100 mg one tablet daily p.o. for 16 weeks, followed by a 4-week post-treatment follow-up.
23512|NCT02513771|O2|Outcome|Placebo Arm|Placebo for sitagliptin one tablet daily p.o.for 16 weeks, followed by a 4-week post-treatment follow-up.
23513|NCT02513771|O1|Outcome|Sitagliptin Arm|Sitagliptin (Januvia) 100 mg one tablet daily p.o. for 16 weeks, followed by a 4-week post-treatment follow-up.
23514|NCT02513771|O2|Outcome|Placebo Arm|Placebo for sitagliptin one tablet daily p.o.for 16 weeks, followed by a 4-week post-treatment follow-up.
23515|NCT02513771|O1|Outcome|Sitagliptin Arm|Sitagliptin (Januvia) 100 mg one tablet daily p.o. for 16 weeks, followed by a 4-week post-treatment follow-up.
23516|NCT02513771|O2|Outcome|Placebo Arm|Placebo for sitagliptin one tablet daily p.o.for 16 weeks, followed by a 4-week post-treatment follow-up.
23517|NCT02513771|O1|Outcome|Sitagliptin Arm|Sitagliptin (Januvia) 100 mg one tablet daily p.o. for 16 weeks, followed by a 4-week post-treatment follow-up.
23518|NCT02513771|O2|Outcome|Placebo Arm|Placebo for sitagliptin one tablet daily p.o.for 16 weeks, followed by a 4-week post-treatment follow-up.
23519|NCT02513771|O1|Outcome|Sitagliptin Arm|Sitagliptin (Januvia) 100 mg one tablet daily p.o. for 16 weeks, followed by a 4-week post-treatment follow-up.
23520|NCT02513771|O2|Outcome|Placebo Arm|Placebo for sitagliptin one tablet daily p.o.for 16 weeks, followed by a 4-week post-treatment follow-up.
23521|NCT02513771|O1|Outcome|Sitagliptin Arm|Sitagliptin (Januvia) 100 mg one tablet daily p.o. for 16 weeks, followed by a 4-week post-treatment follow-up.
23522|NCT02513771|O2|Outcome|Placebo Arm|Placebo for sitagliptin one tablet daily p.o.for 16 weeks, followed by a 4-week post-treatment follow-up.
23523|NCT02513771|O1|Outcome|Sitagliptin Arm|Sitagliptin (Januvia) 100 mg one tablet daily p.o. for 16 weeks, followed by a 4-week post-treatment follow-up.
23524|NCT02513771|O2|Outcome|Placebo Arm|Placebo for sitagliptin one tablet daily p.o.for 16 weeks, followed by a 4-week post-treatment follow-up.
23525|NCT02513771|O1|Outcome|Sitagliptin Arm|Sitagliptin (Januvia) 100 mg one tablet daily p.o. for 16 weeks, followed by a 4-week post-treatment follow-up.
23526|NCT02513771|O2|Outcome|Placebo Arm|Placebo for sitagliptin one tablet daily p.o.for 16 weeks, followed by a 4-week post-treatment follow-up.
23527|NCT02513771|O1|Outcome|Sitagliptin Arm|Sitagliptin (Januvia) 100 mg one tablet daily p.o. for 16 weeks, followed by a 4-week post-treatment follow-up.
23528|NCT02513771|O2|Outcome|Placebo Arm|Placebo for sitagliptin one tablet daily p.o.for 16 weeks, followed by a 4-week post-treatment follow-up.
23529|NCT02513771|O1|Outcome|Sitagliptin Arm|Sitagliptin (Januvia) 100 mg one tablet daily p.o. for 16 weeks, followed by a 4-week post-treatment follow-up.
24819|NCT02498652|O4|Outcome|Treatment R1|Allopurinol 300 mg qd + RDEA3170 2.5 mg qd (Cohort 1)
23530|NCT02513771|E2|Reported Event|Placebo|Placebo for sitagliptin one tablet daily p.o.for 16 weeks, followed by a 4-week post-treatment follow-up.
23531|NCT02513771|E1|Reported Event|Sitagliptin|Sitagliptin (Januvia) 100 mg one tablet daily p.o. for 16 weeks, followed by a 4-week post-treatment follow-up.
23532|NCT02513550|B4|Baseline|Total|Total of all reporting groups
23533|NCT02513550|B3|Baseline|80 mg Ixekizumab Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52.
23534|NCT02513550|B2|Baseline|80 mg Ixekizumab Q4W/Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2 as needed to week 52. Placebo administered SQ, Q2W to maintain blind.
23535|NCT02513550|B1|Baseline|80 mg Ixekizumab Q4W|160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.
23536|NCT02513550|P3|Participant Flow|80 mg Ixekizumab Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52.
23537|NCT02513550|P2|Participant Flow|80 mg Ixekizumab Q4W/Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2 as needed to week 52. Placebo administered SQ, Q2W to maintain blind.
23538|NCT02513550|P1|Participant Flow|80 mg Ixekizumab Q4W|160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.
23539|NCT02513550|O3|Outcome|80 mg Ixekizumab Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52.
23540|NCT02513550|O2|Outcome|80 mg Ixekizumab Q4W/Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2 as needed to week 52. Placebo administered SQ, Q2W to maintain blind.
23541|NCT02513550|O1|Outcome|80 mg Ixekizumab Q4W|160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.
23542|NCT02513550|O4|Outcome|80 mg Ixekizumab Q2W Continuous|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52.
23543|NCT02513550|O3|Outcome|80 mg Ixekizumab Q4W/Q2W Step|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2 as needed to week 52. Placebo administered SQ, Q2W to maintain blind.
23544|NCT02513550|O2|Outcome|80 mg Ixekizumab Q4W/Q2W No Step|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2 as needed to week 52. Placebo administered SQ, Q2W to maintain blind.
23545|NCT02513550|O1|Outcome|80 mg Ixekizumab Q4W Continuous|160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.
23546|NCT02513550|O3|Outcome|80 mg Ixekizumab Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52.
23547|NCT02513550|O2|Outcome|80 mg Ixekizumab Q4W/Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2 as needed to week 52. Placebo administered SQ, Q2W to maintain blind.
23548|NCT02513550|O1|Outcome|80 mg Ixekizumab Q4W|160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.
23549|NCT02513550|O3|Outcome|80 mg Ixekizumab Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52.
23550|NCT02513550|O2|Outcome|80 mg Ixekizumab Q4W/Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2 as needed to week 52. Placebo administered SQ, Q2W to maintain blind.
23551|NCT02513550|O1|Outcome|80 mg Ixekizumab Q4W|160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.
23552|NCT02513550|O3|Outcome|80 mg Ixekizumab Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52.
23553|NCT02513550|O2|Outcome|80 mg Ixekizumab Q4W/Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2 as needed to week 52. Placebo administered SQ, Q2W to maintain blind.
23554|NCT02513550|O1|Outcome|80 mg Ixekizumab Q4W|160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.
23555|NCT02513550|O3|Outcome|80 mg Ixekizumab Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52.
23556|NCT02513550|O2|Outcome|80 mg Ixekizumab Q4W/Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2 as needed to week 52. Placebo administered SQ, Q2W to maintain blind.
23557|NCT02513550|O1|Outcome|80 mg Ixekizumab Q4W|160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.
23558|NCT02513550|O3|Outcome|80 mg Ixekizumab Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52.
23559|NCT02513550|O2|Outcome|80 mg Ixekizumab Q4W/Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2 as needed to week 52. Placebo administered SQ, Q2W to maintain blind.
23560|NCT02513550|O1|Outcome|80 mg Ixekizumab Q4W|160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.
23561|NCT02513550|O3|Outcome|80 mg Ixekizumab Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52.
23562|NCT02513550|O2|Outcome|80 mg Ixekizumab Q4W/Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2 as needed to week 52. Placebo administered SQ, Q2W to maintain blind.
23563|NCT02513550|O1|Outcome|80 mg Ixekizumab Q4W|160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.
23564|NCT02513550|O3|Outcome|80 mg Ixekizumab Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52.
23565|NCT02513550|O2|Outcome|80 mg Ixekizumab Q4W/Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2 as needed to week 52. Placebo administered SQ, Q2W to maintain blind.
23566|NCT02513550|O1|Outcome|80 mg Ixekizumab Q4W|160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.
23567|NCT02513550|O3|Outcome|80 mg Ixekizumab Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52.
23568|NCT02513550|O2|Outcome|80 mg Ixekizumab Q4W/Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2 as needed to week 52. Placebo administered SQ, Q2W to maintain blind.
23569|NCT02513550|O1|Outcome|80 mg Ixekizumab Q4W|160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.
23570|NCT02513550|O3|Outcome|80 mg Ixekizumab Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52.
23571|NCT02513550|O2|Outcome|80 mg Ixekizumab Q4W/Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2 as needed to week 52. Placebo administered SQ, Q2W to maintain blind.
23572|NCT02513550|O1|Outcome|80 mg Ixekizumab Q4W|160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.
23573|NCT02513550|O3|Outcome|80 mg Ixekizumab Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52.
23574|NCT02513550|O2|Outcome|80 mg Ixekizumab Q4W/Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2 as needed to week 52. Placebo administered SQ, Q2W to maintain blind.
23575|NCT02513550|O1|Outcome|80 mg Ixekizumab Q4W|160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.
23576|NCT02513550|O3|Outcome|80 mg Ixekizumab Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52.
23577|NCT02513550|O2|Outcome|80 mg Ixekizumab Q4W/Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2 as needed to week 52. Placebo administered SQ, Q2W to maintain blind.
23578|NCT02513550|O1|Outcome|80 mg Ixekizumab Q4W|160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.
23579|NCT02513550|O3|Outcome|80 mg Ixekizumab Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52.
23580|NCT02513550|O2|Outcome|80 mg Ixekizumab Q4W/Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2 as needed to week 52. Placebo administered SQ, Q2W to maintain blind.
23581|NCT02513550|O1|Outcome|80 mg Ixekizumab Q4W|160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.
23582|NCT02513550|O3|Outcome|80 mg Ixekizumab Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52.
23583|NCT02513550|O2|Outcome|80 mg Ixekizumab Q4W/Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2 as needed to week 52. Placebo administered SQ, Q2W to maintain blind.
23584|NCT02513550|O1|Outcome|80 mg Ixekizumab Q4W|160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.
23585|NCT02513550|O3|Outcome|80 mg Ixekizumab Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52.
23586|NCT02513550|O2|Outcome|80 mg Ixekizumab Q4W/Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2 as needed to week 52. Placebo administered SQ, Q2W to maintain blind.
23587|NCT02513550|O1|Outcome|80 mg Ixekizumab Q4W|160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.
23588|NCT02513550|O3|Outcome|80 mg Ixekizumab Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52.
23589|NCT02513550|O2|Outcome|80 mg Ixekizumab Q4W/Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2 as needed to week 52. Placebo administered SQ, Q2W to maintain blind.
23590|NCT02513550|O1|Outcome|80 mg Ixekizumab Q4W|160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.
36452|NCT02389088|O2|Outcome|Phase I - Week 5 - 0 Hour|
23591|NCT02513550|O3|Outcome|80 mg Ixekizumab Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52.
23592|NCT02513550|O2|Outcome|80 mg Ixekizumab Q4W/Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2 as needed to week 52. Placebo administered SQ, Q2W to maintain blind.
23593|NCT02513550|O1|Outcome|80 mg Ixekizumab Q4W|160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.
23594|NCT02513550|O3|Outcome|80 mg Ixekizumab Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52.
23595|NCT02513550|O2|Outcome|80 mg Ixekizumab Q4W/Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2 as needed to week 52. Placebo administered SQ, Q2W to maintain blind.
23596|NCT02513550|O1|Outcome|80 mg Ixekizumab Q4W|160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.
23597|NCT02513550|E3|Reported Event|80 mg Ixekizumab Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52.
23598|NCT02513550|E2|Reported Event|80 mg Ixekizumab Q4W/Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2 as needed to week 52. Placebo administered SQ, Q2W to maintain blind.
23599|NCT02513550|E1|Reported Event|80 mg Ixekizumab Q4W|160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.
23600|NCT02513160|B5|Baseline|Total|Total of all reporting groups
23601|NCT02513160|B4|Baseline|MDI 320 mcg/Day|Beclomethasone dipropionate metered-dose inhaler (MDI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23602|NCT02513160|B3|Baseline|BAI 640 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (80 mcg/inhalation), twice daily for a total daily dose of 640 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23603|NCT02513160|B2|Baseline|BAI 320 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23604|NCT02513160|B1|Baseline|Placebo|Pooled breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) placebo groups. Participants were instructed to take 4 inhalations twice daily for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23605|NCT02513160|P4|Participant Flow|MDI 320 mcg/Day|Beclomethasone dipropionate metered-dose inhaler (MDI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23606|NCT02513160|P3|Participant Flow|BAI 640 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (80 mcg/inhalation), twice daily for a total daily dose of 640 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23607|NCT02513160|P2|Participant Flow|BAI 320 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23608|NCT02513160|P1|Participant Flow|Placebo|Pooled breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) placebo groups. Participants were instructed to take 4 inhalations twice daily for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23609|NCT02513160|O4|Outcome|MDI 320 mcg/Day|Beclomethasone dipropionate metered-dose inhaler (MDI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23610|NCT02513160|O3|Outcome|BAI 640 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (80 mcg/inhalation), twice daily for a total daily dose of 640 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23611|NCT02513160|O2|Outcome|BAI 320 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23612|NCT02513160|O1|Outcome|Placebo|Pooled breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) placebo groups. Participants were instructed to take 4 inhalations twice daily for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23661|NCT02512900|O2|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
36453|NCT02389088|O1|Outcome|Phase I - Week 0 - 24 Hours|
23613|NCT02513160|O4|Outcome|MDI 320 mcg/Day|Beclomethasone dipropionate metered-dose inhaler (MDI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23614|NCT02513160|O3|Outcome|BAI 640 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (80 mcg/inhalation), twice daily for a total daily dose of 640 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23615|NCT02513160|O2|Outcome|BAI 320 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23616|NCT02513160|O1|Outcome|Placebo|Pooled breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) placebo groups. Participants were instructed to take 4 inhalations twice daily for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23617|NCT02513160|O4|Outcome|MDI 320 mcg/Day|Beclomethasone dipropionate metered-dose inhaler (MDI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23618|NCT02513160|O3|Outcome|BAI 640 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (80 mcg/inhalation), twice daily for a total daily dose of 640 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23619|NCT02513160|O2|Outcome|BAI 320 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23620|NCT02513160|O1|Outcome|Placebo|Pooled breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) placebo groups. Participants were instructed to take 4 inhalations twice daily for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23621|NCT02513160|O4|Outcome|MDI 320 mcg/Day|Beclomethasone dipropionate metered-dose inhaler (MDI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23622|NCT02513160|O3|Outcome|BAI 640 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (80 mcg/inhalation), twice daily for a total daily dose of 640 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23623|NCT02513160|O2|Outcome|BAI 320 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23624|NCT02513160|O1|Outcome|Placebo|Pooled breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) placebo groups. Participants were instructed to take 4 inhalations twice daily for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23625|NCT02513160|O4|Outcome|MDI 320 mcg/Day|Beclomethasone dipropionate metered-dose inhaler (MDI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23626|NCT02513160|O3|Outcome|BAI 640 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (80 mcg/inhalation), twice daily for a total daily dose of 640 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23627|NCT02513160|O2|Outcome|BAI 320 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23628|NCT02513160|O1|Outcome|Placebo|Pooled breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) placebo groups. Participants were instructed to take 4 inhalations twice daily for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23629|NCT02513160|O4|Outcome|MDI 320 mcg/Day|Beclomethasone dipropionate metered-dose inhaler (MDI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23630|NCT02513160|O3|Outcome|BAI 640 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (80 mcg/inhalation), twice daily for a total daily dose of 640 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
24820|NCT02498652|O3|Outcome|Treatment A2b|Allopurinol 600 mg (300 mg bid) (Cohorts 1 and 2)
23631|NCT02513160|O2|Outcome|BAI 320 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23632|NCT02513160|O1|Outcome|Placebo|Pooled breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) placebo groups. Participants were instructed to take 4 inhalations twice daily for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23633|NCT02513160|O4|Outcome|MDI 320 mcg/Day|Beclomethasone dipropionate metered-dose inhaler (MDI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23634|NCT02513160|O3|Outcome|BAI 640 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (80 mcg/inhalation), twice daily for a total daily dose of 640 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23635|NCT02513160|O2|Outcome|BAI 320 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23636|NCT02513160|O1|Outcome|Placebo|Pooled breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) placebo groups. Participants were instructed to take 4 inhalations twice daily for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
23637|NCT02513160|E5|Reported Event|MDI 320 mcg/Day|Beclomethasone dipropionate metered-dose inhaler (MDI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for the 6 weeks of the double-blind Treatment Period.
23638|NCT02513160|E4|Reported Event|BAI 640 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (80 mcg/inhalation), twice daily for a total daily dose of 640 mcg for the 6 weeks of the double-blind Treatment Period.
23639|NCT02513160|E3|Reported Event|BAI 320 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for the 6 weeks of the double-blind Treatment Period.
23640|NCT02513160|E2|Reported Event|Placebo|Pooled breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) placebo groups. Participants were instructed to take 4 inhalations twice daily for the 6 weeks of the double-blind Treatment Period.
23641|NCT02513160|E1|Reported Event|Run-in Placebo|Pooled breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) placebo groups. Participants were instructed to take 4 inhalations twice daily for up to 30 days of the single-blind Run-in Period.
23642|NCT02513095|B3|Baseline|Total|Total of all reporting groups
23643|NCT02513095|B2|Baseline|Standard of Care Only (SOC)|Standard of Care (SOC) treatment only, consisting of body cooling and supportive measures implemented immediately.
23644|NCT02513095|B1|Baseline|Ryanodex|"Ryanodex (dantrolene sodium) for injectable suspension administered as an IV bolus, in addition to standard of care (SOC) treatment.~Dantrolene sodium for injectable suspension: Ryanodex will be administered as a rapid IV push as a single doses of 2 mg/kg or as 1 mg/kg."
23645|NCT02513095|P2|Participant Flow|Standard of Care Only (SOC)|Standard of Care (SOC) treatment only, consisting of body cooling and supportive measures implemented immediately.
23646|NCT02513095|P1|Participant Flow|Ryanodex|"Ryanodex (dantrolene sodium) for injectable suspension administered as an IV bolus, in addition to standard of care (SOC) treatment.~Dantrolene sodium for injectable suspension: Ryanodex will be administered as a rapid IV push as a single doses of 2 mg/kg or as 1 mg/kg."
23647|NCT02513095|O2|Outcome|Standard of Care Only (SOC)|Standard of Care (SOC) treatment only, consisting of body cooling and supportive measures implemented immediately.
23648|NCT02513095|O1|Outcome|Ryanodex|"Ryanodex (dantrolene sodium) for injectable suspension administered as an IV bolus, in addition to standard of care (SOC) treatment.~Dantrolene sodium for injectable suspension: Ryanodex will be administered as a rapid IV push as a single doses of 2 mg/kg or as 1 mg/kg."
23649|NCT02513095|E2|Reported Event|Standard of Care Only (SOC)|Standard of Care (SOC) treatment only, consisting of body cooling and supportive measures implemented immediately.
23650|NCT02513095|E1|Reported Event|Ryanodex|"Ryanodex (dantrolene sodium) for injectable suspension administered as an IV bolus, in addition to standard of care (SOC) treatment.~Dantrolene sodium for injectable suspension: Ryanodex will be administered as a rapid IV push as a single doses of 2 mg/kg or as 1 mg/kg."
23651|NCT02512900|B3|Baseline|TOTAL|Total of all reporting groups
23652|NCT02512900|B2|Baseline|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23653|NCT02512900|B1|Baseline|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23654|NCT02512900|P2|Participant Flow|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23655|NCT02512900|P1|Participant Flow|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23656|NCT02512900|O1|Outcome|MEDI9929|On Day 1, a single dose of MEDI9929 was administered subcutaneously to participants, aged 12 to 17 years, inclusive.
23657|NCT02512900|O2|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23658|NCT02512900|O1|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23659|NCT02512900|O2|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23660|NCT02512900|O1|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23662|NCT02512900|O1|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23663|NCT02512900|O2|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23664|NCT02512900|O1|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23665|NCT02512900|O2|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23666|NCT02512900|O1|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23667|NCT02512900|O2|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23668|NCT02512900|O1|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23669|NCT02512900|O2|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23670|NCT02512900|O1|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23671|NCT02512900|O2|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23672|NCT02512900|O1|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23673|NCT02512900|O2|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23674|NCT02512900|O1|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23675|NCT02512900|O2|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23676|NCT02512900|O1|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23677|NCT02512900|O2|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23678|NCT02512900|O1|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23679|NCT02512900|O2|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23680|NCT02512900|O1|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23681|NCT02512900|O2|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23682|NCT02512900|O1|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23683|NCT02512900|E2|Reported Event|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23684|NCT02512900|E1|Reported Event|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
23685|NCT02512783|B3|Baseline|Total|Total of all reporting groups
23686|NCT02512783|B2|Baseline|Normal Saline|"Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.~Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
23687|NCT02512783|B1|Baseline|Lidocaine|"Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.~Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
23688|NCT02512783|P2|Participant Flow|Normal Saline|"Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.~Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
23689|NCT02512783|P1|Participant Flow|Lidocaine|"Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.~Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
23690|NCT02512783|O2|Outcome|Normal Saline|"Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.~Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
23691|NCT02512783|O1|Outcome|Lidocaine|"Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.~Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
23692|NCT02512783|O2|Outcome|Normal Saline|"Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.~Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
23693|NCT02512783|O1|Outcome|Lidocaine|"Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.~Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
23694|NCT02512783|E2|Reported Event|Normal Saline|"Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.~Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
23695|NCT02512783|E1|Reported Event|Lidocaine|"Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.~Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
23897|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
23696|NCT02512679|B1|Baseline|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
23697|NCT02512679|P2|Participant Flow|Cyclophosphamide Dose Level 2|"De-escalation of Cyclophosphamide given by Intravenous (IV) at a total dose of 70 mg/kg, to be divided into two doses of one 35 mg/kg dose per day, for 2 days~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 75 mg/kg, to be divided into two doses of one 35 mg/kg dose per day, for 2 days. After ten patients the de-escalation will begin if the stopping rule is not met."
23698|NCT02512679|P1|Participant Flow|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
23699|NCT02512679|O1|Outcome|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
23700|NCT02512679|O1|Outcome|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
23701|NCT02512679|O1|Outcome|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
23702|NCT02512679|O1|Outcome|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
23703|NCT02512679|O1|Outcome|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
23704|NCT02512679|E1|Reported Event|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
23705|NCT02512393|B3|Baseline|Total|Total of all reporting groups
23706|NCT02512393|B2|Baseline|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23707|NCT02512393|B1|Baseline|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23708|NCT02512393|P2|Participant Flow|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23709|NCT02512393|P1|Participant Flow|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23710|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23711|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
24821|NCT02498652|O2|Outcome|Treatment A2q|Allopurinol 600 mg (qd) (Cohorts 1 and 2)
23712|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23713|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23714|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23715|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23716|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23717|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23718|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23719|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23720|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23721|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23722|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23723|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23724|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23725|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23726|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23727|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23728|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23898|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
23729|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23730|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23731|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23732|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23733|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23734|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23735|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23736|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23737|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23738|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23739|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23740|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23741|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23742|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23743|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23744|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23745|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23899|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
23746|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23747|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23748|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23749|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23750|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23751|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23752|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23753|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23754|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23755|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23756|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23757|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23758|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23759|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23760|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23761|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23762|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23900|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
23763|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23764|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23765|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23766|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23767|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23768|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23769|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23770|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23771|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23772|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23773|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23774|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23775|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23776|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23777|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23778|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23779|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23901|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
23780|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23781|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23782|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23783|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23784|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23785|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23786|NCT02512393|E2|Reported Event|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23787|NCT02512393|E1|Reported Event|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
23788|NCT02512224|B3|Baseline|Total|Total of all reporting groups
23789|NCT02512224|B2|Baseline|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
23790|NCT02512224|B1|Baseline|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
23791|NCT02512224|P2|Participant Flow|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
23792|NCT02512224|P1|Participant Flow|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
23793|NCT02512224|O2|Outcome|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
23794|NCT02512224|O1|Outcome|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
23795|NCT02512224|O2|Outcome|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
23796|NCT02512224|O1|Outcome|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
23797|NCT02512224|O2|Outcome|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
23798|NCT02512224|O1|Outcome|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
23902|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
23799|NCT02512224|O2|Outcome|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
23800|NCT02512224|O1|Outcome|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
23801|NCT02512224|O2|Outcome|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
23802|NCT02512224|O1|Outcome|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
23803|NCT02512224|O2|Outcome|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
23804|NCT02512224|O1|Outcome|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
23805|NCT02512224|E2|Reported Event|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
23806|NCT02512224|E1|Reported Event|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
23807|NCT02512094|B1|Baseline|Elderly Hip Fracture|Age at least 50 years old Hip fractures within 2 weeks since injury
23808|NCT02512094|P1|Participant Flow|Elderly Hip Fracture|Age at least 50 years old Hip fractures within 2 weeks since injury
23809|NCT02512094|O1|Outcome|Elderly Hip Fracture|Age at least 50 years old Hip fractures within 2 weeks since injury
23810|NCT02512094|E1|Reported Event|Elderly Hip Fracture|Age at least 50 years old Hip fractures within 2 weeks since injury
23811|NCT02511782|B4|Baseline|Total|Total of all reporting groups
23812|NCT02511782|B3|Baseline|Healthy Controls|"This study arm includes healthy age matched controls as comparisons to study participants who develop graft versus host disease. These controls may be either healthy age matched siblings of patients who develop acute graft versus host disease or healthy age matched siblings of patients that are seen in the bone marrow transplant, oncology, or hematology clinics. A one-time single skin cell sample will be collected using a D-SQUAME Skin Sampling Disc. Blood samples will not be collected from the healthy controls.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
23813|NCT02511782|B2|Baseline|Chronic Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop chronic graft versus host disease. Skin cell samples will be collected weekly for 4 weeks using the D-SQUAME Skin Sampling Discs. Blood samples will be collected at these same time points.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
23814|NCT02511782|B1|Baseline|Acute Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop acute graft versus host disease. Skin cell samples will be collected using the D-SQUAME Skin Sampling Discs. The first baseline skin sample will be obtained prior to the preparative regimen for stem cell transplant. Samples will be collected weekly after stem cell infusion until 8 weeks, if acute GVHD does not develop. If acute GVHD does develop, weekly samples will continue to be collected until resolution of acute GVHD or development of chronic GVHD, whichever occurs first. Blood samples will be collected at these same time points.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
23815|NCT02511782|P3|Participant Flow|Healthy Controls|"This study arm includes healthy age matched controls as comparisons to study participants who develop graft versus host disease. These controls may be either healthy age matched siblings of patients who develop acute graft versus host disease or healthy age matched siblings of patients that are seen in the bone marrow transplant, oncology, or hematology clinics. A one-time single skin cell sample will be collected using a D-SQUAME Skin Sampling Disc. Blood samples will not be collected from the healthy controls.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
23849|NCT02511431|P3|Participant Flow|Group 3|"Lonafarnib/Ritonavir at 100 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily."
23957|NCT02508194|O2|Outcome|MEDI7510 + IIV|Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
23816|NCT02511782|P2|Participant Flow|Chronic Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop chronic graft versus host disease. Skin cell samples will be collected weekly for 4 weeks using the D-SQUAME Skin Sampling Discs. Blood samples will be collected at these same time points.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
23817|NCT02511782|P1|Participant Flow|Acute Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop acute graft versus host disease. Skin cell samples will be collected using the D-SQUAME Skin Sampling Discs. The first baseline skin sample will be obtained prior to the preparative regimen for stem cell transplant. Samples will be collected weekly after stem cell infusion until 8 weeks, if acute GVHD does not develop. If acute GVHD does develop, weekly samples will continue to be collected until resolution of acute GVHD or development of chronic GVHD, whichever occurs first. Blood samples will be collected at these same time points.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
23818|NCT02511782|O2|Outcome|Healthy Controls|"This study arm includes healthy age matched controls as comparisons to study participants who develop graft versus host disease. These controls may be either healthy age matched siblings of patients who develop acute graft versus host disease or healthy age matched siblings of patients that are seen in the bone marrow transplant, oncology, or hematology clinics. A one-time single skin cell sample will be collected using a D-SQUAME Skin Sampling Disc. Blood samples will not be collected from the healthy controls.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
23819|NCT02511782|O1|Outcome|Acute Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop acute graft versus host disease. Skin cell samples will be collected using the D-SQUAME Skin Sampling Discs. The first baseline skin sample will be obtained prior to the preparative regimen for stem cell transplant. Samples will be collected weekly after stem cell infusion until 8 weeks, if acute GVHD does not develop. If acute GVHD does develop, weekly samples will continue to be collected until resolution of acute GVHD or development of chronic GVHD, whichever occurs first. Blood samples will be collected at these same time points.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
23820|NCT02511782|O3|Outcome|Chronic Graft Versus Host Disease|This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop chronic graft versus host disease.
23821|NCT02511782|O2|Outcome|Healthy Controls|"This study arm includes healthy age matched controls as comparisons to study participants who develop graft versus host disease. These controls may be either healthy age matched siblings of patients who develop acute graft versus host disease or healthy age matched siblings of patients that are seen in the bone marrow transplant, oncology, or hematology clinics. A one-time single skin cell sample will be collected using a D-SQUAME Skin Sampling Disc. Blood samples will not be collected from the healthy controls.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
23822|NCT02511782|O1|Outcome|Acute Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop acute graft versus host disease. Skin cell samples will be collected using the D-SQUAME Skin Sampling Discs. The first baseline skin sample will be obtained prior to the preparative regimen for stem cell transplant. Samples will be collected weekly after stem cell infusion until 8 weeks, if acute GVHD does not develop. If acute GVHD does develop, weekly samples will continue to be collected until resolution of acute GVHD or development of chronic GVHD, whichever occurs first. Blood samples will be collected at these same time points.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
23823|NCT02511782|E3|Reported Event|Healthy Controls|"This study arm includes healthy age matched controls as comparisons to study participants who develop graft versus host disease. These controls may be either healthy age matched siblings of patients who develop acute graft versus host disease or healthy age matched siblings of patients that are seen in the bone marrow transplant, oncology, or hematology clinics. A one-time single skin cell sample will be collected using a D-SQUAME Skin Sampling Disc. Blood samples will not be collected from the healthy controls.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
23824|NCT02511782|E2|Reported Event|Chronic Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop chronic graft versus host disease. Skin cell samples will be collected weekly for 4 weeks using the D-SQUAME Skin Sampling Discs. Blood samples will be collected at these same time points.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
23850|NCT02511431|P2|Participant Flow|Group 2|"Lonafarnib/Ritonavir at 75 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily."
24822|NCT02498652|O1|Outcome|Treatment A1|Allopurinol 300 mg qd (Cohorts 1 and 2)
23825|NCT02511782|E1|Reported Event|Acute Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop acute graft versus host disease. Skin cell samples will be collected using the D-SQUAME Skin Sampling Discs. The first baseline skin sample will be obtained prior to the preparative regimen for stem cell transplant. Samples will be collected weekly after stem cell infusion until 8 weeks, if acute GVHD does not develop. If acute GVHD does develop, weekly samples will continue to be collected until resolution of acute GVHD or development of chronic GVHD, whichever occurs first. Blood samples will be collected at these same time points.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
23826|NCT02511587|B3|Baseline|Total|Total of all reporting groups
23827|NCT02511587|B2|Baseline|Subcutaneous Application|"subcutaneous application of FSME-Immune vaccination~FSME-Immune vaccination: booster vaccination with FSME-Immune"
23828|NCT02511587|B1|Baseline|Intra Muscular Application|"intra muscular application of FSME-Immune vaccination~FSME-Immune vaccination: booster vaccination with FSME-Immune"
23829|NCT02511587|P2|Participant Flow|Subcutaneous Application|"subcutaneous application of FSME-Immune vaccination~FSME-Immune vaccination: booster vaccination with FSME-Immune"
23830|NCT02511587|P1|Participant Flow|Intra Muscular Application|"intra muscular application of FSME-Immune vaccination~FSME-Immune vaccination: booster vaccination with FSME-Immune"
23831|NCT02511587|O2|Outcome|Subcutaneous Application|"subcutaneous application of FSME-Immune vaccination~FSME-Immune vaccination: booster vaccination with FSME-Immune"
23832|NCT02511587|O1|Outcome|Intra Muscular Application|"intra muscular application of FSME-Immune vaccination~FSME-Immune vaccination: booster vaccination with FSME-Immune"
23833|NCT02511587|O2|Outcome|Subcutaneous Application|"subcutaneous application of FSME-Immune vaccination~FSME-Immune vaccination: booster vaccination with FSME-Immune"
23834|NCT02511587|O1|Outcome|Intra Muscular Application|"intra muscular application of FSME-Immune vaccination~FSME-Immune vaccination: booster vaccination with FSME-Immune"
23835|NCT02511587|O2|Outcome|Subcutaneous Application|"subcutaneous application of FSME-Immune vaccination~FSME-Immune vaccination: booster vaccination with FSME-Immune"
23836|NCT02511587|O1|Outcome|Intra Muscular Application|"intra muscular application of FSME-Immune vaccination~FSME-Immune vaccination: booster vaccination with FSME-Immune"
23837|NCT02511587|E2|Reported Event|Subcutaneous Application|"subcutaneous application of FSME-Immune vaccination~FSME-Immune vaccination: booster vaccination with FSME-Immune"
23838|NCT02511587|E1|Reported Event|Intra Muscular Application|"intra muscular application of FSME-Immune vaccination~FSME-Immune vaccination: booster vaccination with FSME-Immune"
23839|NCT02511431|B7|Baseline|Total|Total of all reporting groups
23840|NCT02511431|B6|Baseline|Group 6|"Placebo for 12 weeks then Lonafarnib/Ritonavir at 100 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.~Placebo: Placebo"
23841|NCT02511431|B5|Baseline|Group 5|"Placebo for 12 weeks then Lonafarnib/Ritonavir at 75 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.~Placebo: Placebo"
23842|NCT02511431|B4|Baseline|Group 4|"Placebo for 12 weeks then Lonafarnib/Ritonavir at 50 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.~Placebo: Placebo"
23843|NCT02511431|B3|Baseline|Group 3|"Lonafarnib/Ritonavir at 100 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily."
23844|NCT02511431|B2|Baseline|Group 2|"Lonafarnib/Ritonavir at 75 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily."
23845|NCT02511431|B1|Baseline|Group 1|"Lonafarnib/Ritonavir at 50 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily."
23846|NCT02511431|P6|Participant Flow|Group 6|"Placebo for 12 weeks then Lonafarnib/Ritonavir at 100 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.~Placebo: Placebo"
23847|NCT02511431|P5|Participant Flow|Group 5|"Placebo for 12 weeks then Lonafarnib/Ritonavir at 75 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.~Placebo: Placebo"
23848|NCT02511431|P4|Participant Flow|Group 4|"Placebo for 12 weeks then Lonafarnib/Ritonavir at 50 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.~Placebo: Placebo"
23958|NCT02508194|O1|Outcome|Placebo + IIV|Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
23851|NCT02511431|P1|Participant Flow|Group 1|"Lonafarnib/Ritonavir at 50 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily."
23852|NCT02511431|O6|Outcome|Group 6|"Placebo for 12 weeks then Lonafarnib/Ritonavir at 100 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.~Placebo: Placebo"
23853|NCT02511431|O5|Outcome|Group 5|"Placebo for 12 weeks then Lonafarnib/Ritonavir at 75 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.~Placebo: Placebo"
23854|NCT02511431|O4|Outcome|Group 4|"Placebo for 12 weeks then Lonafarnib/Ritonavir at 50 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.~Placebo: Placebo"
23855|NCT02511431|O3|Outcome|Group 3|"Lonafarnib/Ritonavir at 100 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily."
23856|NCT02511431|O2|Outcome|Group 2|"Lonafarnib/Ritonavir at 75 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily."
23857|NCT02511431|O1|Outcome|Group 1|"Lonafarnib/Ritonavir at 50 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily."
23858|NCT02511431|O6|Outcome|Group 6|"Placebo for 12 weeks then Lonafarnib/Ritonavir at 100 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.~Placebo: Placebo"
23859|NCT02511431|O5|Outcome|Group 5|"Placebo for 12 weeks then Lonafarnib/Ritonavir at 75 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.~Placebo: Placebo"
23860|NCT02511431|O4|Outcome|Group 4|"Placebo for 12 weeks then Lonafarnib/Ritonavir at 50 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.~Placebo: Placebo"
23861|NCT02511431|O3|Outcome|Group 3|"Lonafarnib/Ritonavir at 100 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily."
23862|NCT02511431|O2|Outcome|Group 2|"Lonafarnib/Ritonavir at 75 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily."
23863|NCT02511431|O1|Outcome|Group 1|"Lonafarnib/Ritonavir at 50 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily."
23864|NCT02511431|E6|Reported Event|Group 6|"Placebo for 12 weeks then Lonafarnib/Ritonavir at 100 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.~Placebo: Placebo"
23865|NCT02511431|E5|Reported Event|Group 5|"Placebo for 12 weeks then Lonafarnib/Ritonavir at 75 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.~Placebo: Placebo"
23866|NCT02511431|E4|Reported Event|Group 4|"Placebo for 12 weeks then Lonafarnib/Ritonavir at 50 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.~Placebo: Placebo"
23867|NCT02511431|E3|Reported Event|Group 3|"Lonafarnib/Ritonavir at 100 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily."
23959|NCT02508194|O2|Outcome|MEDI7510 + IIV|Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
23868|NCT02511431|E2|Reported Event|Group 2|"Lonafarnib/Ritonavir at 75 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily."
23869|NCT02511431|E1|Reported Event|Group 1|"Lonafarnib/Ritonavir at 50 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily."
23870|NCT02510820|B1|Baseline|Overall Baseline Characteristics|Participants were randomized to wear either the Synergi/comfilcon A or Biotrue/comfilcon A combination for one month, then cross over to the alternative combination.
23871|NCT02510820|P2|Participant Flow|Biotrue/Comfilcon A Combo, Then Synergi/Comfilcon A Combo|Participants were randomized to wear Biotrue/comfilcon A combination for one month, then cross over to the alternative Synergi/comfilcon A combination.
23872|NCT02510820|P1|Participant Flow|Synergi/Comfilcon A Combo, Then Biotrue/Comfilcon A Combo|Participants were randomized to wear Synergi/comfilcon A combination for one month, then cross over to the alternative Biotrue/comfilcon A combination.
23873|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
23874|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
23875|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
23876|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
23877|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
23878|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
23879|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
23880|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
23881|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
23882|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
23883|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
23884|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
23885|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
23886|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
23887|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
23888|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
23889|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
23890|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
23891|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
23892|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
23893|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
23894|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
23895|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
23896|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
23903|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
23904|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens Synergi: Multipurpose solution"
23905|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
23906|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
23907|NCT02510820|E2|Reported Event|Biotrue/Comfilcon A Combo, Then Synergi/Comfilcon A Combo|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution~Synergi: Multipurpose solution"
23908|NCT02510820|E1|Reported Event|Synergi/Comfilcon A Combo, Then Biotrue/Comfilcon A Combo|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution~Biotrue: Multipurpose solution"
23909|NCT02510014|B3|Baseline|Total|Total of all reporting groups
23910|NCT02510014|B2|Baseline|Roll-over Subjects|Subjects who completed RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 6 months in the Treatment period.
23911|NCT02510014|B1|Baseline|De Novo Subjects|Subjects who did not participate in RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 12 months in the Treatment period.
23912|NCT02510014|P2|Participant Flow|Roll-over Subjects|Subjects who completed RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 6 months in the Treatment period.
23913|NCT02510014|P1|Participant Flow|De Novo Subjects|Subjects who did not participate in RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 12 months in the Treatment period.
23914|NCT02510014|O2|Outcome|Roll-over Subjects|Subjects who completed RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 6 months in the Treatment period.
23915|NCT02510014|O1|Outcome|De Novo Subjects|Subjects who did not participate in RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 12 months in the Treatment period.
23916|NCT02510014|O2|Outcome|Roll-over Subjects|Subjects who completed RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 6 months in the Treatment period.
23917|NCT02510014|O1|Outcome|De Novo Subjects|Subjects who did not participate in RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 12 months in the Treatment period.
23918|NCT02510014|O2|Outcome|Roll-over Subjects|Subjects who completed RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 6 months in the Treatment period.
23919|NCT02510014|O1|Outcome|De Novo Subjects|Subjects who did not participate in RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 12 months in the Treatment period.
23920|NCT02510014|O2|Outcome|Roll-over Subjects|Subjects who completed RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 6 months in the Treatment period.
23921|NCT02510014|O1|Outcome|De Novo Subjects|Subjects who did not participate in RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 12 months in the Treatment period.
23922|NCT02510014|O2|Outcome|Roll-over Subjects|Subjects who completed RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 6 months in the Treatment period.
23923|NCT02510014|O1|Outcome|De Novo Subjects|Subjects who did not participate in RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 12 months in the Treatment period.
23924|NCT02510014|O2|Outcome|Roll-over Subjects|Subjects who completed RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 6 months in the Treatment period.
24823|NCT02498652|O9|Outcome|Treatment R6|Allopurinol 300 mg qd + RDEA3170 20 mg qd (Cohort 2)
23925|NCT02510014|O1|Outcome|De Novo Subjects|Subjects who did not participate in RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 12 months in the Treatment period.
23926|NCT02510014|O2|Outcome|Roll-over Subjects|Subjects who completed RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 6 months in the Treatment period.
23927|NCT02510014|O1|Outcome|De Novo Subjects|Subjects who did not participate in RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 12 months in the Treatment period.
23928|NCT02510014|O2|Outcome|Roll-over Subjects|Subjects who completed RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 6 months in the Treatment period.
23929|NCT02510014|O1|Outcome|De Novo Subjects|Subjects who did not participate in RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 12 months in the Treatment period.
23930|NCT02510014|E2|Reported Event|Roll-over Subjects|Subjects who completed RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 6 months in the Treatment period.
23931|NCT02510014|E1|Reported Event|De Novo Subjects|Subjects who did not participate in RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 12 months in the Treatment period.
23932|NCT02508194|B3|Baseline|Total|Total of all reporting groups
23933|NCT02508194|B2|Baseline|MEDI7510 + IIV|Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
23934|NCT02508194|B1|Baseline|Placebo + IIV|Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
23935|NCT02508194|P2|Participant Flow|MEDI7510 + IIV|Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
23936|NCT02508194|P1|Participant Flow|Placebo + Inactivated Influenza Vaccine (IIV)|Participants received a single intramuscular (IM) injection of placebo (matched with MEDI7510) in one arm and single IM injection of (IIV) in the contralateral arm.
23937|NCT02508194|O2|Outcome|MEDI7510 + IIV|Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
23938|NCT02508194|O1|Outcome|Placebo + IIV|Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
23939|NCT02508194|O2|Outcome|MEDI7510 + IIV|Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
23940|NCT02508194|O1|Outcome|Placebo + IIV|Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
23941|NCT02508194|O2|Outcome|MEDI7510 + IIV|Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
23942|NCT02508194|O1|Outcome|Placebo + IIV|Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
23943|NCT02508194|O2|Outcome|MEDI7510 + IIV|Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
23944|NCT02508194|O1|Outcome|Placebo + IIV|Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
23945|NCT02508194|O2|Outcome|MEDI7510 + IIV|Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
23946|NCT02508194|O1|Outcome|Placebo + IIV|Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
23947|NCT02508194|O2|Outcome|MEDI7510 + IIV|Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
23948|NCT02508194|O1|Outcome|Placebo + IIV|Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
23949|NCT02508194|O2|Outcome|MEDI7510 + IIV|Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
23950|NCT02508194|O1|Outcome|Placebo + IIV|Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
23951|NCT02508194|O2|Outcome|MEDI7510 + IIV|Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
23952|NCT02508194|O1|Outcome|Placebo + IIV|Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
23953|NCT02508194|O2|Outcome|MEDI7510 + IIV|Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
23954|NCT02508194|O1|Outcome|Placebo + IIV|Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
23955|NCT02508194|O2|Outcome|MEDI7510 + IIV|Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
23956|NCT02508194|O1|Outcome|Placebo + IIV|Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
23960|NCT02508194|O1|Outcome|Placebo + IIV|Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
23961|NCT02508194|O2|Outcome|MEDI7510 + IIV|Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
23962|NCT02508194|O1|Outcome|Placebo + IIV|Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
23963|NCT02508194|O2|Outcome|MEDI7510 + IIV|Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
23964|NCT02508194|O1|Outcome|Placebo + IIV|Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
23965|NCT02508194|O2|Outcome|MEDI7510 + IIV|Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
23966|NCT02508194|O1|Outcome|Placebo + IIV|Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
23967|NCT02508194|O2|Outcome|MEDI7510 + IIV|Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
23968|NCT02508194|O1|Outcome|Placebo + IIV|Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
23969|NCT02508194|O2|Outcome|MEDI7510 + IIV|Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
23970|NCT02508194|O1|Outcome|Placebo + IIV|Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
23971|NCT02508194|E2|Reported Event|MEDI7510+IIV|Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
23972|NCT02508194|E1|Reported Event|Placebo + IIV|Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
23973|NCT02508103|B3|Baseline|Total|Total of all reporting groups
23974|NCT02508103|B2|Baseline|Placebo, Then Oxytocin|"Participants were randomized to receive Intransal Placebo for late luteal phase administration during one menstrual cycle, then received Intranasal Oxytocin for late luteal phase administration of a subsequent menstrual cycle.~Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days; Intranasal Placebo spray (3x/day) for 4-5 days"
23975|NCT02508103|B1|Baseline|Oxytocin, Then Placebo|"Participants were randomized to receive Intransal Oxytocin for late luteal phase administration during one menstrual cycle, then received Intranasal Placebo for late luteal phase administration of a subsequent menstrual cycle.~Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days; Intranasal Placebo spray (3x/day) for 4-5 days"
23976|NCT02508103|P2|Participant Flow|Placebo, Then Oxytocin|"Participants were randomized to receive Intransal Placebo for late luteal phase administration during one menstrual cycle, then received Oxytocin for late luteal phase administration of a subsequent menstrual cycle.~Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days; Intranasal Placebo spray (3x/day) for 4-5 days"
23977|NCT02508103|P1|Participant Flow|Oxytocin, Then Placebo|"Participants were randomized to receive Intransal Oxytocin for late luteal phase administration during one menstrual cycle, then received Placebo for late luteal phase administration of a subsequent menstrual cycle.~Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days; Intranasal Placebo spray (3x/day) for 4-5 days"
23978|NCT02508103|O2|Outcome|Placebo|Intranasal Placebo spray (3x/day) for 4-5 days
23979|NCT02508103|O1|Outcome|Oxytocin|Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days
23980|NCT02508103|O2|Outcome|Placebo|Intranasal Placebo spray (3x/day) for 4-5 days
23981|NCT02508103|O1|Outcome|Oxytocin|Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days
23982|NCT02508103|E2|Reported Event|Placebo|Intranasal Placebo spray (3x/day) for 4-5 days
23983|NCT02508103|E1|Reported Event|Oxytocin|Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days
23984|NCT02507752|B1|Baseline|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
23985|NCT02507752|P1|Participant Flow|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
23986|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
23987|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
23988|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
23989|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
23990|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
23991|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
23992|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
23993|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
23994|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
23995|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
23996|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
23997|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
23998|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
23999|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
24000|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
24001|NCT02507752|E1|Reported Event|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
24002|NCT02507388|B3|Baseline|Total|Total of all reporting groups
24003|NCT02507388|B2|Baseline|Brolucizumab 6 mg|Brolucizumab 6 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
24004|NCT02507388|B1|Baseline|Brolucizumab 3 mg|Brolucizumab 3 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
24005|NCT02507388|P2|Participant Flow|Brolucizumab 6 mg|Brolucizumab 6 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
24006|NCT02507388|P1|Participant Flow|Brolucizumab 3 mg|Brolucizumab 3 milligrams (mg)/50 microliters (μL) administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
24007|NCT02507388|O2|Outcome|Brolucizumab 6 mg|Brolucizumab 6 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
24008|NCT02507388|O1|Outcome|Brolucizumab 3 mg|Brolucizumab 3 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
24009|NCT02507388|O2|Outcome|Brolucizumab 6 mg|Brolucizumab 6 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
24010|NCT02507388|O1|Outcome|Brolucizumab 3 mg|Brolucizumab 3 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
24011|NCT02507388|O2|Outcome|Brolucizumab 6 mg|Brolucizumab 6 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
24012|NCT02507388|O1|Outcome|Brolucizumab 3 mg|Brolucizumab 3 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
24013|NCT02507388|O2|Outcome|Brolucizumab 6 mg|Brolucizumab 6 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
24014|NCT02507388|O1|Outcome|Brolucizumab 3 mg|Brolucizumab 3 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
24015|NCT02507388|O2|Outcome|Brolucizumab 6 mg|Brolucizumab 6 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
24016|NCT02507388|O1|Outcome|Brolucizumab 3 mg|Brolucizumab 3 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
24017|NCT02507388|O2|Outcome|Brolucizumab 6 mg|Brolucizumab 6 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
24018|NCT02507388|O1|Outcome|Brolucizumab 3 mg|Brolucizumab 3 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
24019|NCT02507388|O2|Outcome|Brolucizumab 6 mg|Brolucizumab 6 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
24020|NCT02507388|O1|Outcome|Brolucizumab 3 mg|Brolucizumab 3 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
24021|NCT02507388|O2|Outcome|Brolucizumab 6 mg|Brolucizumab 6 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
24022|NCT02507388|O1|Outcome|Brolucizumab 3 mg|Brolucizumab 3 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
24023|NCT02507388|E3|Reported Event|Brolucizumab 6 mg|All subjects who received an IVT injection of brolucizumab 6 mg
24024|NCT02507388|E2|Reported Event|Brolucizumab 3 mg|All subjects who received an IVT injection of brolucizumab 3 mg
24025|NCT02507388|E1|Reported Event|Pre-Treatment|All subjects who signed an informed consent form and were assigned an identification number (51), minus one subject exited as a screen failure prior to treatment initiation
24026|NCT02507375|B3|Baseline|Total|Total of all reporting groups
24027|NCT02507375|B2|Baseline|Erlotinib 150 mg + Pertuzumab 420 mg|Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
24028|NCT02507375|B1|Baseline|Erlotinib 100 mg + Pertuzumab 420 mg|Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
24029|NCT02507375|P2|Participant Flow|Erlotinib 150 mg + Pertuzumab 420 mg|Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
24030|NCT02507375|P1|Participant Flow|Erlotinib 100 mg + Pertuzumab 420 mg|Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
24824|NCT02498652|O8|Outcome|Treatment R5|Allopurinol 300 mg qd + RDEA3170 15 mg qd (Cohort 1)
24031|NCT02507375|O1|Outcome|Pertuzumab + Erlotinib|In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
24032|NCT02507375|O1|Outcome|Pertuzumab + Erlotinib|In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
24033|NCT02507375|O1|Outcome|Pertuzumab + Erlotinib|In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
24034|NCT02507375|O1|Outcome|Pertuzumab + Erlotinib|In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
24035|NCT02507375|O1|Outcome|Pertuzumab + Erlotinib|In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
24036|NCT02507375|O1|Outcome|Pertuzumab + Erlotinib|In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
24037|NCT02507375|O2|Outcome|Erlotinib 150 mg + Pertuzumab 420 mg|Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
24038|NCT02507375|O1|Outcome|Erlotinib 100 mg + Pertuzumab 420 mg|Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
24039|NCT02507375|O3|Outcome|Erlotinib 150 mg + Pertuzumab 420 mg|Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
24040|NCT02507375|O2|Outcome|Erlotinib 100 mg + Pertuzumab 420 mg|Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
24041|NCT02507375|O1|Outcome|Total Population|Erlotinib + pertuzumab
24042|NCT02507375|O2|Outcome|Erlotinib 150 mg + Pertuzumab 420 mg|Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
24043|NCT02507375|O1|Outcome|Erlotinib 100 mg + Pertuzumab 420 mg|Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
24044|NCT02507375|E2|Reported Event|Cohort 2|Erlotinib 150 mg + pertuzumab 420 mg
24045|NCT02507375|E1|Reported Event|Cohort 1|Erlotinib 100 mg + pertuzumab 420 mg
24046|NCT02507219|B1|Baseline|All Study Participants|Subjects received either placebo, 200 mg of ibuprofen or 600 mg of ibuprofen after signing the consent form for this study in a randomized, double-blind, counter-balanced study. Each participant received all interventions. Each study session occurred 1-2 weeks following the previous session. Ibuprofen was capsuled, and identical placebo capsules were produced.
24047|NCT02507219|P6|Participant Flow|Ibuprofen 600mg, Ibuprofen 200mg, Placebo|Subjects will receive one dose of placebo or ibuprofen at three testing sessions in a randomized, double-blind, counter-balanced order. In this arm, the subject will receive the doses in the following order: Ibuprofen 600mg, Placebo, Ibuprofen 200mg. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced.
24048|NCT02507219|P5|Participant Flow|Ibuprofen 600mg, Placebo, Ibuprofen 200mg|Subjects will receive one dose of placebo or ibuprofen at three testing sessions in a randomized, double-blind, counter-balanced order. In this arm, the subject will receive the doses in the following order: Ibuprofen 600mg, Placebo, Ibuprofen 200mg. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced.
24049|NCT02507219|P4|Participant Flow|Ibuprofen 200mg, Ibuprofen 600mg, Placebo|Subjects will receive one dose of placebo or ibuprofen at three testing sessions in a randomized, double-blind, counter-balanced order. In this arm, the subject will receive the doses in the following order: Ibuprofen 200mg, Ibuprofen 600mg, Placebo. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced.
24050|NCT02507219|P3|Participant Flow|Ibuprofen, 200mg, Placebo, Ibuprofen 600mg|Subjects will receive one dose of placebo or ibuprofen at three testing sessions in a randomized, double-blind, counter-balanced order. In this arm, the subject will receive the doses in the following order: Ibuprofen 200mg, Placebo, Ibuprofen 600mg. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced.
24051|NCT02507219|P2|Participant Flow|Placebo, Ibuprofen, 600mg, Ibuprofen 200mg|Subjects will receive one dose of placebo or ibuprofen at three testing sessions in a randomized, double-blind, counter-balanced order. In this arm, the subject will receive the doses in the following order: Placebo, Ibuprofen 600mg, Ibuprofen 200mg. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced.
24052|NCT02507219|P1|Participant Flow|Placebo, Ibuprofen 200mg, Ibuprofen 600mg|Subjects will receive one dose of placebo or ibuprofen at three testing sessions in a randomized, double-blind, counter-balanced order. In this arm, the subject will receive the doses in the following order: Placebo, Ibuprofen 200mg, Ibuprofen 600mg. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced.
24053|NCT02507219|O3|Outcome|Ibuprofen, 600mg|"Subjects will receive one oral dose of 600mg at one of the three testing sessions. Ibuprofen capsules will be produced by a local compounding pharmacy in Tulsa, OK.~Ibuprofen: On the day of sessions 2-4, subjects will receive either placebo, 200 mg of ibuprofen or 600 mg of ibuprofen after signing the consent form for this study in a randomized, double-blind, counter balanced order. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced."
24054|NCT02507219|O2|Outcome|Ibuprofen, 200mg|"Subjects will receive one oral dose of 200mg at one of the three testing sessions. Ibuprofen capsules will be produced by a local compounding pharmacy in Tulsa, OK.~Ibuprofen: On the day of sessions 2-4, subjects will receive either placebo, 200 mg of ibuprofen or 600 mg of ibuprofen after signing the consent form for this study in a randomized, double-blind, counter balanced order. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced."
24055|NCT02507219|O1|Outcome|Placebo|"Subjects will receive one dose of placebo (sugar pill) at one of the three testing sessions . Placebo capsules will be produced in the same manner as the ibuprofen by a local compounding pharmacy in Tulsa, OK.~Ibuprofen: On the day of sessions 2-4, subjects will receive either placebo, 200 mg of ibuprofen or 600 mg of ibuprofen after signing the consent form for this study in a randomized, double-blind, counter balanced order. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced."
24056|NCT02507219|E3|Reported Event|Ibuprofen, 600mg|"Subjects will receive one oral dose of 600mg at one of the three testing sessions. Ibuprofen capsules will be produced by a local compounding pharmacy in Tulsa, OK.~Ibuprofen: On the day of sessions 2-4, subjects will receive either placebo, 200 mg of ibuprofen or 600 mg of ibuprofen after signing the consent form for this study in a randomized, double-blind, counter balanced order. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced."
24057|NCT02507219|E2|Reported Event|Ibuprofen, 200mg|"Subjects will receive one oral dose of 200mg at one of the three testing sessions. Ibuprofen capsules will be produced by a local compounding pharmacy in Tulsa, OK.~Ibuprofen: On the day of sessions 2-4, subjects will receive either placebo, 200 mg of ibuprofen or 600 mg of ibuprofen after signing the consent form for this study in a randomized, double-blind, counter balanced order. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced."
24058|NCT02507219|E1|Reported Event|Placebo|"Subjects will receive one dose of placebo (sugar pill) at one of the three testing sessions . Placebo capsules will be produced in the same manner as the ibuprofen by a local compounding pharmacy in Tulsa, OK.~Ibuprofen: On the day of sessions 2-4, subjects will receive either placebo, 200 mg of ibuprofen or 600 mg of ibuprofen after signing the consent form for this study in a randomized, double-blind, counter balanced order. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced."
24059|NCT02506881|B5|Baseline|Total|Total of all reporting groups
24060|NCT02506881|B4|Baseline|Aranesp → BCD-066 - Intravenous|Volunteers in this group initially will receive a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.
24061|NCT02506881|B3|Baseline|BCD-066 → Aranesp - Intravenous|Volunteers in this group initially will receive a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.
24062|NCT02506881|B2|Baseline|Aranesp → BCD-066 - Subcutaneous|Volunteers in this group initially will receive a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.
24063|NCT02506881|B1|Baseline|BCD-066 → Aranesp - Subcutaneous|Volunteers in this group initially will receive a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.
24064|NCT02506881|P4|Participant Flow|Aranesp → BCD-066 - Intravenous|"Volunteers in this group initially will receive a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.~Darbepoetin alfa"
24184|NCT02504775|O1|Outcome|Tylenol® Caplets|Participants were orally administered with one caplet of Tylenol® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
24065|NCT02506881|P3|Participant Flow|BCD-066 → Aranesp - Intravenous|"Volunteers in this group initially will receive a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.~Darbepoetin alfa"
24066|NCT02506881|P2|Participant Flow|Aranesp → BCD-066 - Subcutaneous|"Volunteers in this group initially will receive a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.~Darbepoetin alfa"
24067|NCT02506881|P1|Participant Flow|BCD-066 → Aranesp - Subcutaneous|"Volunteers in this group initially will receive a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.~Darbepoetin alfa"
24068|NCT02506881|O4|Outcome|Aranesp® - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
24069|NCT02506881|O3|Outcome|BCD-066 - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
24070|NCT02506881|O2|Outcome|Aranesp® - Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
24071|NCT02506881|O1|Outcome|BCD-066 - Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
24072|NCT02506881|O4|Outcome|Aranesp® - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
24073|NCT02506881|O3|Outcome|BCD-066 - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
24074|NCT02506881|O2|Outcome|Aranesp® - Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
24075|NCT02506881|O1|Outcome|BCD-066 - Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
24076|NCT02506881|O4|Outcome|Aranesp® - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
24077|NCT02506881|O3|Outcome|BCD-066 - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
24078|NCT02506881|O2|Outcome|Aranesp® Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
24079|NCT02506881|O1|Outcome|BCD-066 Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
24080|NCT02506881|O4|Outcome|Aranesp® - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
24081|NCT02506881|O3|Outcome|BCD-066 - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
24082|NCT02506881|O2|Outcome|Aranesp® Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
24083|NCT02506881|O1|Outcome|BCD-066 Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
24084|NCT02506881|O4|Outcome|Aranesp® - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
24085|NCT02506881|O3|Outcome|BCD-066 - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
24086|NCT02506881|O2|Outcome|Aranesp® Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
24087|NCT02506881|O1|Outcome|BCD-066 Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
24088|NCT02506881|O4|Outcome|Aranesp® - Intravenous|"Pharmacokinetics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.~Cmax of darbepoetin alfa 0 to 72 hours is reported."
24089|NCT02506881|O3|Outcome|BCD-066 - Intravenous|"Pharmacokinetics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.~Cmax of darbepoetin alfa 0 to 72 hours is reported."
24090|NCT02506881|O2|Outcome|Aranesp® Subcutaneous|"Pharmacokinetics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.~Cmax of darbepoetin alfa 0 to 336 hours is reported."
24091|NCT02506881|O1|Outcome|BCD-066 Subcutaneous|"Pharmacokinetics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.~Cmax of darbepoetin alfa 0 to 336 hours is reported."
24092|NCT02506881|O4|Outcome|Aranesp® - Intravenous|"Pharmacokinetics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.~AUC of darbepoetin alfa 0 to 72 hours is reported."
24093|NCT02506881|O3|Outcome|BCD-066 - Intravenous|"Pharmacokinetics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.~AUC of darbepoetin alfa 0 to 72 hours is reported."
24094|NCT02506881|O2|Outcome|Aranesp® Subcutaneous|"Pharmacokinetics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.~AUC of darbepoetin alfa 0 to 336 hours is reported."
24095|NCT02506881|O1|Outcome|BCD-066 Subcutaneous|"Pharmacokinetics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.~AUC of darbepoetin alfa 0 to 336 hours is reported."
24096|NCT02506881|E4|Reported Event|Aranesp® - Intravenous|Safety parameters of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg are presented.
24097|NCT02506881|E3|Reported Event|BCD-066 - Intravenous|Safety parameters of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg are presented.
24098|NCT02506881|E2|Reported Event|Aranesp® Subcutaneous|Safety parameters of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg are presented.
24099|NCT02506881|E1|Reported Event|BCD-066 Subcutaneous|Safety parameters of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg are presented.
24100|NCT02506309|B3|Baseline|Total|Total of all reporting groups
36454|NCT02389088|O10|Outcome|Phase II - Week 6 - 24 Hours|
24101|NCT02506309|B2|Baseline|TOT Trans Obturato Tape/Sling|"TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).~TOT - inside-out trans-obturator tape/sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
24102|NCT02506309|B1|Baseline|SIS Single Incision Sling|"SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).~SIS - Innovative fixation single incision sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
24103|NCT02506309|P2|Participant Flow|TOT Trans Obturato Tape/Sling|"TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).~TOT - inside-out trans-obturator tape/sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
24104|NCT02506309|P1|Participant Flow|SIS Single Incision Sling|"SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).~SIS - Innovative fixation single incision sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
24105|NCT02506309|O2|Outcome|TOT Trans Obturato Tape/Sling|"TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).~TOT - inside-out trans-obturator tape/sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
24106|NCT02506309|O1|Outcome|SIS Single Incision Sling|"SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).~SIS - Innovative fixation single incision sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
24107|NCT02506309|O2|Outcome|TOT Trans Obturato Tape/Sling|"TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).~TOT - inside-out trans-obturator tape/sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
24108|NCT02506309|O1|Outcome|SIS Single Incision Sling|"SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).~SIS - Innovative fixation single incision sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
24109|NCT02506309|O2|Outcome|TOT Trans Obturato Tape/Sling|"TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).~TOT - inside-out trans-obturator tape/sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
24110|NCT02506309|O1|Outcome|SIS Single Incision Sling|"SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).~SIS - Innovative fixation single incision sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
24111|NCT02506309|O2|Outcome|TOT Trans Obturato Tape/Sling|"TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).~TOT - inside-out trans-obturator tape/sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
24112|NCT02506309|O1|Outcome|SIS Single Incision Sling|"SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).~SIS - Innovative fixation single incision sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
24113|NCT02506309|E2|Reported Event|TOT Trans Obturato Tape/Sling|"TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).~TOT - inside-out trans-obturator tape/sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
24114|NCT02506309|E1|Reported Event|SIS Single Incision Sling|"SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).~SIS - Innovative fixation single incision sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
24115|NCT02506257|B5|Baseline|Total|Total of all reporting groups
24116|NCT02506257|B4|Baseline|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24117|NCT02506257|B3|Baseline|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24118|NCT02506257|B2|Baseline|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24342|NCT02503085|O1|Outcome|Treatment B: Nurofen for Children® 400 mg/20 mL (Fasted)|Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.
24119|NCT02506257|B1|Baseline|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24120|NCT02506257|P4|Participant Flow|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24121|NCT02506257|P3|Participant Flow|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24122|NCT02506257|P2|Participant Flow|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24123|NCT02506257|P1|Participant Flow|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24124|NCT02506257|O4|Outcome|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24125|NCT02506257|O3|Outcome|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24126|NCT02506257|O2|Outcome|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24127|NCT02506257|O1|Outcome|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24128|NCT02506257|O4|Outcome|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24129|NCT02506257|O3|Outcome|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24130|NCT02506257|O2|Outcome|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24131|NCT02506257|O1|Outcome|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24132|NCT02506257|O4|Outcome|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24133|NCT02506257|O3|Outcome|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24134|NCT02506257|O2|Outcome|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24135|NCT02506257|O1|Outcome|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24136|NCT02506257|O4|Outcome|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24137|NCT02506257|O3|Outcome|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24138|NCT02506257|O2|Outcome|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24139|NCT02506257|O1|Outcome|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24140|NCT02506257|O4|Outcome|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24141|NCT02506257|O3|Outcome|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24142|NCT02506257|O2|Outcome|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24143|NCT02506257|O1|Outcome|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24144|NCT02506257|O4|Outcome|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24145|NCT02506257|O3|Outcome|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24146|NCT02506257|O2|Outcome|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24147|NCT02506257|O1|Outcome|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24148|NCT02506257|E4|Reported Event|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24149|NCT02506257|E3|Reported Event|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24150|NCT02506257|E2|Reported Event|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24151|NCT02506257|E1|Reported Event|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
24152|NCT02506101|B3|Baseline|Total|Total of all reporting groups
24153|NCT02506101|B2|Baseline|no Intervention|untreated
24154|NCT02506101|B1|Baseline|Narrow-band Ultraviolet B Phototherapy|"We will use the 3 Series PC & SP Phototherapy Cabinet for treatment of vitiligo.~narrow-band ultraviolet B phototherapy: There are two types of UVB: broad band and narrow band, with the major difference being that narrow band emits a smaller range of ultraviolet light, typically 311-312 nm. NB-UVB is a clinically indicated treatment for vitiligo lesions and treatments are usually administered in an outpatient setting 3 times a week."
24155|NCT02506101|P2|Participant Flow|no Intervention|untreated
24156|NCT02506101|P1|Participant Flow|Narrow-band Ultraviolet B Phototherapy|"We will use the 3 Series PC & SP Phototherapy Cabinet for treatment of vitiligo.~narrow-band ultraviolet B phototherapy: There are two types of UVB: broad band and narrow band, with the major difference being that narrow band emits a smaller range of ultraviolet light, typically 311-312 nm. NB-UVB is a clinically indicated treatment for vitiligo lesions and treatments are usually administered in an outpatient setting 3 times a week."
24157|NCT02506101|O2|Outcome|no Intervention|untreated
24158|NCT02506101|O1|Outcome|Narrow-band Ultraviolet B Phototherapy|"We will use the 3 Series PC & SP Phototherapy Cabinet for treatment of vitiligo.~narrow-band ultraviolet B phototherapy: There are two types of UVB: broad band and narrow band, with the major difference being that narrow band emits a smaller range of ultraviolet light, typically 311-312 nm. NB-UVB is a clinically indicated treatment for vitiligo lesions and treatments are usually administered in an outpatient setting 3 times a week."
24159|NCT02506101|O2|Outcome|no Intervention|untreated
24160|NCT02506101|O1|Outcome|Narrow-band Ultraviolet B Phototherapy|"We will use the 3 Series PC & SP Phototherapy Cabinet for treatment of vitiligo.~narrow-band ultraviolet B phototherapy: There are two types of UVB: broad band and narrow band, with the major difference being that narrow band emits a smaller range of ultraviolet light, typically 311-312 nm. NB-UVB is a clinically indicated treatment for vitiligo lesions and treatments are usually administered in an outpatient setting 3 times a week."
24161|NCT02506101|O2|Outcome|no Intervention|untreated
24162|NCT02506101|O1|Outcome|Narrow-band Ultraviolet B Phototherapy|"We will use the 3 Series PC & SP Phototherapy Cabinet for treatment of vitiligo.~narrow-band ultraviolet B phototherapy: There are two types of UVB: broad band and narrow band, with the major difference being that narrow band emits a smaller range of ultraviolet light, typically 311-312 nm. NB-UVB is a clinically indicated treatment for vitiligo lesions and treatments are usually administered in an outpatient setting 3 times a week."
24163|NCT02506101|O2|Outcome|no Intervention|untreated
24164|NCT02506101|O1|Outcome|Narrow-band Ultraviolet B Phototherapy|"We will use the 3 Series PC & SP Phototherapy Cabinet for treatment of vitiligo.~narrow-band ultraviolet B phototherapy: There are two types of UVB: broad band and narrow band, with the major difference being that narrow band emits a smaller range of ultraviolet light, typically 311-312 nm. NB-UVB is a clinically indicated treatment for vitiligo lesions and treatments are usually administered in an outpatient setting 3 times a week."
24165|NCT02506101|O2|Outcome|no Intervention|untreated
24166|NCT02506101|O1|Outcome|Narrow-band Ultraviolet B Phototherapy|"We will use the 3 Series PC & SP Phototherapy Cabinet for treatment of vitiligo.~narrow-band ultraviolet B phototherapy: There are two types of UVB: broad band and narrow band, with the major difference being that narrow band emits a smaller range of ultraviolet light, typically 311-312 nm. NB-UVB is a clinically indicated treatment for vitiligo lesions and treatments are usually administered in an outpatient setting 3 times a week."
24167|NCT02506101|E2|Reported Event|no Intervention|untreated
24168|NCT02506101|E1|Reported Event|Narrow-band Ultraviolet B Phototherapy|"We will use the 3 Series PC & SP Phototherapy Cabinet for treatment of vitiligo.~narrow-band ultraviolet B phototherapy: There are two types of UVB: broad band and narrow band, with the major difference being that narrow band emits a smaller range of ultraviolet light, typically 311-312 nm. NB-UVB is a clinically indicated treatment for vitiligo lesions and treatments are usually administered in an outpatient setting 3 times a week."
24169|NCT02504931|B3|Baseline|Total|Total of all reporting groups
24170|NCT02504931|B2|Baseline|Placebo|"Matching placebo capsules will be filled with corn starch only on the same schedule as the Sertraline.~Subjects in the Placebo arm also will receive COPE therapy (Concurrent Treatment with Prolonged Exposure)which involves 12 sessions of manualized cognitive and behavioral therapy including exposure therapy for PTSD.~Placebo: A Randomized Controlled Trial Design will randomize subjects to one of two arms. Placebo is the control medication treatment arm."
24343|NCT02503085|O4|Outcome|Treatment C: Algifor Dolo Junior® 400 mg/20 mL (Fed)|Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.
24171|NCT02504931|B1|Baseline|Sertraline|"Subjects will receive a fixed dose of 150 mg sertraline per day. Sertraline dose will be gradually increased by giving sertraline subjects capsules filled with 50 mg for the first three days and then capsules filled with 100 mg for 4 days before beginning the 150 mg per day in the second week. After completing the study Visit 12, subjects will be given an additional two week supply of medicine to gradually taper down so as to minimize any withdrawal discomfort.~Subjects in the Sertraline arm also will receive COPE therapy (Concurrent Treatment with Prolonged Exposure)which involves 12 sessions of manualized cognitive and behavioral therapy including exposure therapy for PTSD.~Sertraline: A Randomized Controlled Trial Design will randomize subjects to one of two arms. Sertraline is the active medication treatment arm."
24172|NCT02504931|P2|Participant Flow|Placebo|"Matching placebo capsules will be filled with corn starch only on the same schedule as the Sertraline.~Subjects in the Placebo arm also will receive COPE therapy (Concurrent Treatment with Prolonged Exposure)which involves 12 sessions of manualized cognitive and behavioral therapy including exposure therapy for PTSD.~Placebo: A Randomized Controlled Trial Design will randomize subjects to one of two arms. Placebo is the control medication treatment arm."
24173|NCT02504931|P1|Participant Flow|Sertraline|"Subjects will receive a fixed dose of 150 mg sertraline per day. Sertraline dose will be gradually increased by giving sertraline subjects capsules filled with 50 mg for the first three days and then capsules filled with 100 mg for 4 days before beginning the 150 mg per day in the second week. After completing the study Visit 12, subjects will be given an additional two week supply of medicine to gradually taper down so as to minimize any withdrawal discomfort.~Subjects in the Sertraline arm also will receive COPE therapy (Concurrent Treatment with Prolonged Exposure)which involves 12 sessions of manualized cognitive and behavioral therapy including exposure therapy for PTSD.~Sertraline: A Randomized Controlled Trial Design will randomize subjects to one of two arms. Sertraline is the active medication treatment arm."
24174|NCT02504931|O2|Outcome|Placebo|"Matching placebo capsules will be filled with corn starch only on the same schedule as the Sertraline.~Subjects in the Placebo arm also will receive COPE therapy (Concurrent Treatment with Prolonged Exposure)which involves 12 sessions of manualized cognitive and behavioral therapy including exposure therapy for PTSD.~Placebo: A Randomized Controlled Trial Design will randomize subjects to one of two arms. Placebo is the control medication treatment arm."
24175|NCT02504931|O1|Outcome|Sertraline|"Subjects will receive a fixed dose of 150 mg sertraline per day. Sertraline dose will be gradually increased by giving sertraline subjects capsules filled with 50 mg for the first three days and then capsules filled with 100 mg for 4 days before beginning the 150 mg per day in the second week. After completing the study Visit 12, subjects will be given an additional two week supply of medicine to gradually taper down so as to minimize any withdrawal discomfort.~Subjects in the Sertraline arm also will receive COPE therapy (Concurrent Treatment with Prolonged Exposure)which involves 12 sessions of manualized cognitive and behavioral therapy including exposure therapy for PTSD.~Sertraline: A Randomized Controlled Trial Design will randomize subjects to one of two arms. Sertraline is the active medication treatment arm."
24176|NCT02504931|O2|Outcome|Placebo|"Matching placebo capsules will be filled with corn starch only on the same schedule as the Sertraline.~Subjects in the Placebo arm also will receive COPE therapy (Concurrent Treatment with Prolonged Exposure)which involves 12 sessions of manualized cognitive and behavioral therapy including exposure therapy for PTSD.~Placebo: A Randomized Controlled Trial Design will randomize subjects to one of two arms. Placebo is the control medication treatment arm."
24177|NCT02504931|O1|Outcome|Sertraline|"Subjects will receive a fixed dose of 150 mg sertraline per day. Sertraline dose will be gradually increased by giving sertraline subjects capsules filled with 50 mg for the first three days and then capsules filled with 100 mg for 4 days before beginning the 150 mg per day in the second week. After completing the study Visit 12, subjects will be given an additional two week supply of medicine to gradually taper down so as to minimize any withdrawal discomfort.~Subjects in the Sertraline arm also will receive COPE therapy (Concurrent Treatment with Prolonged Exposure)which involves 12 sessions of manualized cognitive and behavioral therapy including exposure therapy for PTSD.~Sertraline: A Randomized Controlled Trial Design will randomize subjects to one of two arms. Sertraline is the active medication treatment arm."
24178|NCT02504931|E2|Reported Event|Placebo|"Matching placebo capsules will be filled with corn starch only on the same schedule as the Sertraline.~Subjects in the Placebo arm also will receive COPE therapy (Concurrent Treatment with Prolonged Exposure)which involves 12 sessions of manualized cognitive and behavioral therapy including exposure therapy for PTSD.~Placebo: A Randomized Controlled Trial Design will randomize subjects to one of two arms. Placebo is the control medication treatment arm."
24179|NCT02504931|E1|Reported Event|Sertraline|"Subjects will receive a fixed dose of 150 mg sertraline per day. Sertraline dose will be gradually increased by giving sertraline subjects capsules filled with 50 mg for the first three days and then capsules filled with 100 mg for 4 days before beginning the 150 mg per day in the second week. After completing the study Visit 12, subjects will be given an additional two week supply of medicine to gradually taper down so as to minimize any withdrawal discomfort.~Subjects in the Sertraline arm also will receive COPE therapy (Concurrent Treatment with Prolonged Exposure)which involves 12 sessions of manualized cognitive and behavioral therapy including exposure therapy for PTSD.~Sertraline: A Randomized Controlled Trial Design will randomize subjects to one of two arms. Sertraline is the active medication treatment arm."
24180|NCT02504775|B1|Baseline|Overall Participants|Total number of participants who were randomized and received treatment.
24181|NCT02504775|P2|Participant Flow|Mejoral® 500 Tablets (Test), Then Tylenol® Caplets (Reference)|Participants first received one tablet of Mejoral® Tablets (500 mg of paracetamol), orally with 250 ml of water at room temperature, in a single dose, under minimum 10 h of fasting. After a washout period of 72 h, they then received one tablet of Tylenol® 500 Caplets (500 mg of paracetamol), orally with 250 ml of water at room temperature, in a single dose, under minimum 10 h of fasting.
24182|NCT02504775|P1|Participant Flow|Tylenol® Caplets (Reference), Then Mejoral® 500 Tablets (Test)|Participants first received one tablet of Tylenol® Caplets [500 milligram (mg) of paracetamol], orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h of fasting. After a washout period of 72 h, they then received one tablet of Mejoral® 500 tablets (500 mg of paracetamol), orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h of fasting.
24183|NCT02504775|O2|Outcome|Mejoral® 500 Tablets|Participants were orally administered with one tablet of Mejoral® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
24185|NCT02504775|O2|Outcome|Mejoral® 500 Tablets|Participants were orally administered with one tablet of Mejoral® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
24186|NCT02504775|O1|Outcome|Tylenol® Caplets|Participants were orally administered with one caplet of Tylenol® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
24187|NCT02504775|O2|Outcome|Mejoral® 500 Tablets|Participants were orally administered with one tablet of Mejoral® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
24188|NCT02504775|O1|Outcome|Tylenol® Caplets|Participants were orally administered with one caplet of Tylenol® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
24189|NCT02504775|O2|Outcome|Mejoral® 500 Tablets (Test)|Participants were orally administered with one tablet of Mejoral® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
24190|NCT02504775|O1|Outcome|Tylenol® Caplets (Reference)|Participants were orally administered with one caplet of Tylenol® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
24191|NCT02504775|E2|Reported Event|Mejoral® 500 Tablets|Participants will first receive one tablet (500 mg of paracetamol) of Mejoral® 500 tablets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting. After a washout period of 72 h, they then will receive one tablet (500 mg of paracetamol) of Tylenol® Caplets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting.
24192|NCT02504775|E1|Reported Event|Tylenol® Caplets|Participants will first receive one tablet [500 milligram (mg) of paracetamol] of Tylenol® Caplets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting. After a washout period of 72 h, they then will receive one tablet (500 mg of paracetamol) of Mejoral® 500 tablets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting.
24193|NCT02504723|B3|Baseline|Total|Total of all reporting groups
24194|NCT02504723|B2|Baseline|Cyanoacrylate Injection|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices.~cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
24195|NCT02504723|B1|Baseline|Cyanoacrylate Injection Plus Carvedilol|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose.~carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure >90 mm Hg.~cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
24196|NCT02504723|P2|Participant Flow|Cyanoacrylate Injection|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices.~cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
24197|NCT02504723|P1|Participant Flow|Cyanoacrylate Injection Plus Carvedilol|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose.~carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure >90 mm Hg.~cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
24198|NCT02504723|O2|Outcome|Cyanoacrylate Injection|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices.~cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
24199|NCT02504723|O1|Outcome|Cyanoacrylate Injection Plus Carvedilol|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose.~carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure >90 mm Hg.~cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
24200|NCT02504723|O2|Outcome|Cyanoacrylate Injection|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices.~cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
24201|NCT02504723|O1|Outcome|Cyanoacrylate Injection Plus Carvedilol|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose.~carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure >90 mm Hg.~cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
24202|NCT02504723|O2|Outcome|Cyanoacrylate Injection|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices.~cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
24345|NCT02503085|O2|Outcome|Treatment A: Nurofen for Children® 400 mg/20 mL (Fed)|Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.
24203|NCT02504723|O1|Outcome|Cyanoacrylate Injection Plus Carvedilol|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose.~carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure >90 mm Hg.~cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
24204|NCT02504723|O2|Outcome|Cyanoacrylate Injection|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices.~cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
24205|NCT02504723|O1|Outcome|Cyanoacrylate Injection Plus Carvedilol|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose.~carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure >90 mm Hg.~cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
24206|NCT02504723|E2|Reported Event|Cyanoacrylate Injection|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices.~cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
24207|NCT02504723|E1|Reported Event|Cyanoacrylate Injection Plus Carvedilol|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose.~carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure >90 mm Hg.~cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
24208|NCT02504541|B1|Baseline|Testosterone Enanthate Auto-injector|Testosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
24209|NCT02504541|P1|Participant Flow|Testosterone Enanthate Auto-injector|Testosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
24210|NCT02504541|O1|Outcome|Testosterone Enanthate Auto-injector|Testosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
24211|NCT02504541|E1|Reported Event|Testosterone Enanthate Auto-injector|Testosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
24212|NCT02504502|B3|Baseline|Total|Total of all reporting groups
24213|NCT02504502|B2|Baseline|Enhanced Genomic Report|"Those resulting in variants of significance will received routine clinical care and access to the enhanced genomic lab report.~Enhanced Genomic Report: Routine clinical care vs. enhanced genomic report"
24214|NCT02504502|B1|Baseline|Control With Delayed Access|"Those resulting in variants of significance will receive routine clinical care and receive the enhanced genomic report after returning 3 month survey.~Routine Clinical Care: Participants will receive routine clinical care. After returning the 3 month survey the participants will also receive the enhanced genomic report."
24215|NCT02504502|P2|Participant Flow|Routine Clinical Care Plus Enhanced Genomic Report|Routine clinical care and access to the enhanced genomic lab report upon completion of the baseline survey. Participants in this arm will receive only one survey at 3 months post enhanced report.
24216|NCT02504502|P1|Participant Flow|Routine Care With Delayed Access to Report|Participants will receive routine clinical care with a copy of their standard laboratory report. After completion of the 3 month survey, participants will receive the enhanced report, followed by another survey 3 months after receiving the enhanced report.
24217|NCT02504502|O2|Outcome|Routine Clinical Care Plus Enhanced Genomic Report|Routine clinical care and access to the enhanced genomic lab report upon completion of the baseline survey. Participants in this arm will receive only one survey at 3 months post enhanced report.
24218|NCT02504502|O1|Outcome|Routine Clinical Care First, Then Enhanced Report|Participants will receive routine clinical care with a copy of their standard laboratory report. After completion of the 3 month survey, participants will receive the enhanced report, followed by another survey 3 months after receiving the enhanced report.
24219|NCT02504502|E2|Reported Event|Routine Clinical Care Plus Enhanced Genomic Report|Routine clinical care and access to the enhanced genomic lab report upon completion of the baseline survey. Participants in this arm will receive only one survey at 3 months post enhanced report.
24220|NCT02504502|E1|Reported Event|Routine Clinical Care First, Then Enhanced Report|Participants will receive routine clinical care with a copy of their standard laboratory report. After completion of the 3 month survey, participants will receive the enhanced report, followed by another survey 3 months after receiving the enhanced report.
24221|NCT02504320|B5|Baseline|Total|Total of all reporting groups
24222|NCT02504320|B4|Baseline|Treatment Sequence BCAD|Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 1 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3 orally, once on Day 1 of Period 2 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 3 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 4 (D).
24825|NCT02498652|O7|Outcome|Treatment R4|Allopurinol 300 mg qd + RDEA3170 10 mg qd (Cohort 2)
24223|NCT02504320|B3|Baseline|Treatment Sequence CDBA|Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 1 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4 orally, once on Day 1 of Period 2 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 3 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 4 (A).
24224|NCT02504320|B2|Baseline|Treatment Sequence DACB|Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 1 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1 orally, once on Day 1 of Period 2 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 3 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 4 (B).
24225|NCT02504320|B1|Baseline|Treatment Sequence ABDC|Febuxostat XR 80 mg capsule Formulation 1 (F1), orally, once on Day 1 of Period 1 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 2 (F2), orally, once on Day 1 of Period 2 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 4 (F4), orally, once on Day 1 of Period 3 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 3 (F3), orally, once on Day 1 of Period 4 (C).
24226|NCT02504320|P4|Participant Flow|Treatment Sequence BCAD|Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 1 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3 orally, once on Day 1 of Period 2 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 3 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 4 (D).
24227|NCT02504320|P3|Participant Flow|Treatment Sequence CDBA|Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 1 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4 orally, once on Day 1 of Period 2 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 3 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 4 (A).
24228|NCT02504320|P2|Participant Flow|Treatment Sequence DACB|Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 1 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1 orally, once on Day 1 of Period 2 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 3 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 4 (B).
24229|NCT02504320|P1|Participant Flow|Treatment Sequence ABDC|Febuxostat XR 80 mg capsule Formulation 1 (F1), orally, once on Day 1 of Period 1 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 2 (F2), orally, once on Day 1 of Period 2 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 4 (F4), orally, once on Day 1 of Period 3 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 3 (F3), orally, once on Day 1 of Period 4 (C).
24230|NCT02504320|O4|Outcome|Regimen D: Febuxostat XR 80 mg Formulation 4|Febuxostat XR 80 mg capsule formulation 4 (F4), orally, once on Day 1 of periods 1, 2, 3 or 4.
24231|NCT02504320|O3|Outcome|Regimen C: Febuxostat XR 80 mg Formulation 3|Febuxostat XR 80 mg capsule formulation 3 (F3), orally, once on Day 1 of periods 1, 2, 3 or 4.
24232|NCT02504320|O2|Outcome|Regimen B: Febuxostat XR 80 mg Formulation 2|Febuxostat XR 80 mg capsule formulation 2 (F2), orally, once on Day 1 of periods 1, 2, 3 or 4.
24233|NCT02504320|O1|Outcome|Regimen A: Febuxostat XR 80 mg Formulation 1|Febuxostat XR 80 mg capsule formulation 1 (F1), orally, once on Day 1 of periods 1, 2, 3 or 4.
24234|NCT02504320|O4|Outcome|Regimen D: Febuxostat XR 80 mg Formulation 4|Febuxostat XR 80 mg capsule formulation 4 (F4), orally, once on Day 1 of periods 1, 2, 3 or 4.
24235|NCT02504320|O3|Outcome|Regimen C: Febuxostat XR 80 mg Formulation 3|Febuxostat XR 80 mg capsule formulation 3 (F3), orally, once on Day 1 of periods 1, 2, 3 or 4.
24236|NCT02504320|O2|Outcome|Regimen B: Febuxostat XR 80 mg Formulation 2|Febuxostat XR 80 mg capsule formulation 2 (F2), orally, once on Day 1 of periods 1, 2, 3 or 4.
24237|NCT02504320|O1|Outcome|Regimen A: Febuxostat XR 80 mg Formulation 1|Febuxostat XR 80 mg capsule formulation 1 (F1), orally, once on Day 1 of periods 1, 2, 3 or 4.
24238|NCT02504320|O4|Outcome|Regimen D: Febuxostat XR 80 mg Formulation 4|Febuxostat XR 80 mg capsule formulation 4 (F4), orally, once on Day 1 of periods 1, 2, 3 or 4.
24239|NCT02504320|O3|Outcome|Regimen C: Febuxostat XR 80 mg Formulation 3|Febuxostat XR 80 mg capsule formulation 3 (F3), orally, once on Day 1 of periods 1, 2, 3 or 4.
24240|NCT02504320|O2|Outcome|Regimen B: Febuxostat XR 80 mg Formulation 2|Febuxostat XR 80 mg capsule formulation 2 (F2), orally, once on Day 1 of periods 1, 2, 3 or 4.
24241|NCT02504320|O1|Outcome|Regimen A: Febuxostat XR 80 mg Formulation 1|Febuxostat XR 80 mg capsule formulation 1 (F1), orally, once on Day 1 of periods 1, 2, 3 or 4.
24242|NCT02504320|E4|Reported Event|Regimen D: Febuxostat XR 80 mg Formulation 4|Febuxostat XR 80 mg capsule formulation 4 (F4), orally, once on Day 1 of periods 1, 2, 3 or 4.
24243|NCT02504320|E3|Reported Event|Regimen C: Febuxostat XR 80 mg Formulation 3|Febuxostat XR 80 mg capsule formulation 3 (F3), orally, once on Day 1 of periods 1, 2, 3 or 4.
24244|NCT02504320|E2|Reported Event|Regimen B: Febuxostat XR 80 mg Formulation 2|Febuxostat XR 80 mg capsule formulation 2 (F2), orally, once on Day 1 of periods 1, 2, 3 or 4.
24245|NCT02504320|E1|Reported Event|Regimen A: Febuxostat XR 80 mg Formulation 1|Febuxostat XR 80 mg capsule formulation 1 (F1), orally, once on Day 1 of periods 1, 2, 3 or 4.
24246|NCT02504099|B1|Baseline|OBV/PTV/r ± DSV ± RBV for 12 or 24 Weeks|OBV/PTV/r (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) with or without dasabuvir (250 mg twice daily) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on HCV genotype/subtype and presence of cirrhosis.
24247|NCT02504099|P1|Participant Flow|OBV/PTV/r ± DSV ± RBV for 12 or 24 Weeks|OBV/PTV/r (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) with or without dasabuvir (250 mg twice daily) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on HCV genotype/subtype and presence of cirrhosis.
24826|NCT02498652|O6|Outcome|Treatment R3|Allopurinol 300 mg qd + RDEA3170 7.5 mg qd (Cohort 1)
24248|NCT02504099|O1|Outcome|OBV/PTV/r ± DSV ± RBV for 12 or 24 Weeks|OBV/PTV/r (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) with or without dasabuvir (250 mg twice daily) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on HCV genotype/subtype and presence of cirrhosis.
24249|NCT02504099|O1|Outcome|OBV/PTV/r ± DSV ± RBV for 12 or 24 Weeks|OBV/PTV/r (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) with or without dasabuvir (250 mg twice daily) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on HCV genotype/subtype and presence of cirrhosis.
24250|NCT02504099|O1|Outcome|OBV/PTV/r ± DSV ± RBV for 12 or 24 Weeks|OBV/PTV/r (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) with or without dasabuvir (250 mg twice daily) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on HCV genotype/subtype and presence of cirrhosis.
24251|NCT02504099|O1|Outcome|OBV/PTV/r ± DSV ± RBV for 12 or 24 Weeks|OBV/PTV/r (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) with or without dasabuvir (250 mg twice daily) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on HCV genotype/subtype and presence of cirrhosis.
24252|NCT02504099|O1|Outcome|OBV/PTV/r ± DSV ± RBV for 12 or 24 Weeks|OBV/PTV/r (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) with or without dasabuvir (250 mg twice daily) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on HCV genotype/subtype and presence of cirrhosis.
24253|NCT02504099|E1|Reported Event|OBV/PTV/r ± DSV ± RBV for 12 or 24 Weeks|OBV/PTV/r (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) with or without dasabuvir (250 mg twice daily) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on HCV genotype/subtype and presence of cirrhosis.
24254|NCT02504073|B1|Baseline|PT's Working With Stroke Patients in NW-Switzerland|Physiotherapists from Bruderholzspital, RehaB Basel, Klinik Tschugg, Reha Rheinfelden, RehaClinic Zurzach
24255|NCT02504073|P1|Participant Flow|PT's Working With Stroke Patients in NW-Switzerland|Physiotherapists from Bruderholzspital, RehaB Basel, Klinik Tschugg, Reha Rheinfelden, RehaClinic Zurzach
24256|NCT02504073|O1|Outcome|PT's Working in Stroke in NW-Switzerland|"54 Physiotherapists from Bruderholzspital, RehaB Basel, Klinik Tschugg, Reha Rheinfelden, RehaClinic Zurzach are asked to analyse videos of 6 hemiplegic patients when walking. They are asked to write down their main observations, the major problem and hypotheses about how this major problem is produced.~There is no intervention.~No intervention: No intervention"
24257|NCT02504073|O1|Outcome|PT's Working in Stroke in NW-Switzerland|"54 Physiotherapists from Bruderholzspital, RehaB Basel, Klinik Tschugg, Reha Rheinfelden, RehaClinic Zurzach are asked to analyse videos of 6 hemiplegic patients when walking. They are asked to write down their main observations, the major problem and hypotheses about how this major problem is produced.~There is no intervention.~No intervention: No intervention"
24258|NCT02504073|O1|Outcome|PT's Working With Stroke Patients in NW-Switzerland|Physiotherapists from Bruderholzspital, RehaB Basel, Klinik Tschugg, Reha Rheinfelden, RehaClinic Zurzach
24259|NCT02504073|E1|Reported Event|PT's Working With Stroke Patients in NW-Switzerland|Physiotherapists from Bruderholzspital, RehaB Basel, Klinik Tschugg, Reha Rheinfelden, RehaClinic Zurzach
24260|NCT02503982|B1|Baseline|Solid Organ Transplanted Children|"Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.~prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg."
24261|NCT02503982|P1|Participant Flow|Solid Organ Transplanted Children|"Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.~prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg."
24262|NCT02503982|O1|Outcome|Solid Organ Transplanted Children|"Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.~prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg."
24263|NCT02503982|E1|Reported Event|Solid Organ Transplanted Children|"Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.~prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg."
24264|NCT02503865|B4|Baseline|Total|Total of all reporting groups
24265|NCT02503865|B3|Baseline|Healthy People|64 healthy people
24266|NCT02503865|B2|Baseline|"Analimentary Detoxication"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
24267|NCT02503865|B1|Baseline|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
24268|NCT02503865|P3|Participant Flow|Healthy People|64 healthy people
24269|NCT02503865|P2|Participant Flow|"Analimentary Detoxication"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
24270|NCT02503865|P1|Participant Flow|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
24271|NCT02503865|O3|Outcome|Healthy People|64 healthy people
24272|NCT02503865|O2|Outcome|"Analimentary Detoxication"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
24827|NCT02498652|O5|Outcome|Treatment R2|Allopurinol 300 mg qd + RDEA3170 5 mg qd (Cohort 2)
24273|NCT02503865|O1|Outcome|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
24274|NCT02503865|O3|Outcome|Healthy People|64 healthy people
24275|NCT02503865|O2|Outcome|"Analimentary Detoxication"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
24276|NCT02503865|O1|Outcome|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
24277|NCT02503865|O3|Outcome|Healthy People|64 healthy people
24278|NCT02503865|O2|Outcome|"Analimentary Detoxication Weight Loss"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
24279|NCT02503865|O1|Outcome|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
24280|NCT02503865|O3|Outcome|Healthy People|64 healthy people
24281|NCT02503865|O2|Outcome|"Analimentary Detoxication Weight Loss"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
24282|NCT02503865|O1|Outcome|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
24283|NCT02503865|O3|Outcome|Healthy People|64 healthy people
24284|NCT02503865|O2|Outcome|"Analimentary Detoxication Weight Loss"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
24285|NCT02503865|O1|Outcome|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
24286|NCT02503865|E3|Reported Event|Healthy People|64 healthy people
24287|NCT02503865|E2|Reported Event|"Analimentary Detoxication"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
24288|NCT02503865|E1|Reported Event|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
24289|NCT02503787|B1|Baseline|Open Label Treatment|Spinal Cord Stimulation (SCS)
24290|NCT02503787|P1|Participant Flow|Open Label Treatment|Spinal Cord Stimulation (SCS)
24291|NCT02503787|O1|Outcome|Open Label Treatment|Spinal Cord Stimulation (SCS)
24292|NCT02503787|O1|Outcome|Open Label Treatment|Spinal Cord Stimulation (SCS)
24293|NCT02503787|O1|Outcome|Open Label Treatment|Spinal Cord Stimulation (SCS)
24294|NCT02503787|O1|Outcome|Open Label Treatment|Spinal Cord Stimulation (SCS)
24295|NCT02503787|E1|Reported Event|Device: Neurostimulator|"RestoreSensor SureScan MRI Rechargeable Neurostimulator~RestoreSensor SureScan MRI Rechargeable Neurostimulator: RestoreSensor SureScan MRI Rechargeable Neurostimulator"
24296|NCT02503254|B3|Baseline|Total|Total of all reporting groups
24297|NCT02503254|B2|Baseline|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
24298|NCT02503254|B1|Baseline|CHTP 1.0|Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
24299|NCT02503254|P2|Participant Flow|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
24300|NCT02503254|P1|Participant Flow|CHTP 1.0|Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
24301|NCT02503254|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
24302|NCT02503254|O1|Outcome|CHTP 1.0|Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
24303|NCT02503254|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
24304|NCT02503254|O1|Outcome|CHTP 1.0|Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
24305|NCT02503254|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
24306|NCT02503254|O1|Outcome|CHTP 1.0|Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
24307|NCT02503254|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
24308|NCT02503254|O1|Outcome|CHTP 1.0|Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
24309|NCT02503254|E3|Reported Event|Enrolled But Not Randomized|Subjects who tried the CHTP 1.0 at Admission (Day -3) but were not randomized
24310|NCT02503254|E2|Reported Event|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
24311|NCT02503254|E1|Reported Event|CHTP 1.0|Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
24312|NCT02503215|B1|Baseline|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance~Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
24344|NCT02503085|O3|Outcome|Treatment D: Algifor Dolo Junior® 400 mg/20 mL (Fasted)|Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.
24828|NCT02498652|O4|Outcome|Treatment R1|Allopurinol 300 mg qd + RDEA3170 2.5 mg qd (Cohort 1)
24313|NCT02503215|P1|Participant Flow|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance~Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
24314|NCT02503215|O1|Outcome|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance~Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
24315|NCT02503215|O1|Outcome|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance~Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
24316|NCT02503215|O1|Outcome|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance~Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
24317|NCT02503215|E1|Reported Event|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance~Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
24318|NCT02503085|B1|Baseline|Overall Study|"Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted and fed conditions.~Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted and fed conditions."
24319|NCT02503085|P4|Participant Flow|Sequence 4—ADBC: Nurofen for Children® - Algifor Dolo Junior®|"A = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.~D = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.~B = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.~C = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition."
24320|NCT02503085|P3|Participant Flow|Sequence 3—CBDA: Nurofen for Children® - Algifor Dolo Junior®|"C = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.~B = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.~D = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.~A = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition."
24321|NCT02503085|P2|Participant Flow|Sequence 2—DCAB: Nurofen for Children® - Algifor Dolo Junior®|"D = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.~C = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.~A = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.~B = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition."
24322|NCT02503085|P1|Participant Flow|Sequence 1—BACD: Nurofen for Children® - Algifor Dolo Junior®|"B = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.~A = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.~C = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.~D = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition."
24323|NCT02503085|O4|Outcome|Treatment C: Algifor Dolo Junior® 400 mg/20 mL (Fed)|Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.
24324|NCT02503085|O3|Outcome|Treatment D: Algifor Dolo Junior® 400 mg/20 mL (Fasted)|Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.
24325|NCT02503085|O2|Outcome|Treatment A: Nurofen for Children® 400 mg/20 mL (Fed)|Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.
24326|NCT02503085|O1|Outcome|Treatment B: Nurofen for Children® 400 mg/20 mL (Fasted)|Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.
24327|NCT02503085|O4|Outcome|Treatment C: Algifor Dolo Junior® 400 mg/20 mL (Fed)|Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.
24328|NCT02503085|O3|Outcome|Treatment D: Algifor Dolo Junior® 400 mg/20 mL (Fasted)|Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.
24329|NCT02503085|O2|Outcome|Treatment A: Nurofen for Children® 400 mg/20 mL (Fed)|Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.
24330|NCT02503085|O1|Outcome|Treatment B: Nurofen for Children® 400 mg/20 mL (Fasted)|Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.
24331|NCT02503085|O4|Outcome|Treatment C: Algifor Dolo Junior® 400 mg/20 mL (Fed)|Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.
24332|NCT02503085|O3|Outcome|Treatment D: Algifor Dolo Junior® 400 mg/20 mL (Fasted)|Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.
24333|NCT02503085|O2|Outcome|Treatment A: Nurofen for Children® 400 mg/20 mL (Fed)|Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.
24334|NCT02503085|O1|Outcome|Treatment B: Nurofen for Children® 400 mg/20 mL (Fasted)|Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.
24335|NCT02503085|O4|Outcome|Treatment C: Algifor Dolo Junior® 400 mg/20 mL (Fed)|Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.
24336|NCT02503085|O3|Outcome|Treatment D: Algifor Dolo Junior® 400 mg/20 mL (Fasted)|Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.
24337|NCT02503085|O2|Outcome|Treatment A: Nurofen for Children® 400 mg/20 mL (Fed)|Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.
24338|NCT02503085|O1|Outcome|Treatment B: Nurofen for Children® 400 mg/20 mL (Fasted)|Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.
24339|NCT02503085|O4|Outcome|Treatment C: Algifor Dolo Junior® 400 mg/20 mL (Fed)|Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.
24340|NCT02503085|O3|Outcome|Treatment D: Algifor Dolo Junior® 400 mg/20 mL (Fasted)|Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.
24341|NCT02503085|O2|Outcome|Treatment A: Nurofen for Children® 400 mg/20 mL (Fed)|Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.
24829|NCT02498652|O3|Outcome|Treatment A2b|Allopurinol 600 mg (300 mg bid) (Cohorts 1 and 2)
24346|NCT02503085|O1|Outcome|Treatment B: Nurofen for Children® 400 mg/20 mL (Fasted)|Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.
24347|NCT02503085|O4|Outcome|Treatment C: Algifor Dolo Junior® 400 mg/20 mL (Fed)|Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.
24348|NCT02503085|O3|Outcome|Treatment D: Algifor Dolo Junior® 400 mg/20 mL (Fasted)|Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.
24349|NCT02503085|O2|Outcome|Treatment A: Nurofen for Children® 400 mg/20 mL (Fed)|Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.
24350|NCT02503085|O1|Outcome|Treatment B: Nurofen for Children® 400 mg/20 mL (Fasted)|Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.
24351|NCT02503085|O4|Outcome|Treatment C: Algifor Dolo Junior® 400 mg/20 mL (Fed)|Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.
24352|NCT02503085|O3|Outcome|Treatment D: Algifor Dolo Junior® 400 mg/20 mL (Fasted)|Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.
24353|NCT02503085|O2|Outcome|Treatment A: Nurofen for Children® 400 mg/20 mL (Fed)|Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.
24354|NCT02503085|O1|Outcome|Treatment B: Nurofen for Children® 400 mg/20 mL (Fasted)|Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.
24355|NCT02503085|O4|Outcome|Treatment C: Algifor Dolo Junior® 400 mg/20 mL (Fed)|Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.
24356|NCT02503085|O3|Outcome|Treatment D: Algifor Dolo Junior® 400 mg/20 mL (Fasted)|Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.
24357|NCT02503085|O2|Outcome|Treatment A: Nurofen for Children® 400 mg/20 mL (Fed)|Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.
24358|NCT02503085|O1|Outcome|Treatment B: Nurofen for Children® 400 mg/20 mL (Fasted)|Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.
24359|NCT02503085|E1|Reported Event|Overall Study|"Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted and fed conditions.~Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted and fed conditions."
24360|NCT02502734|B1|Baseline|Fluticasone Furoate and Placebo in Any of the Two Sequences|Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 1 participants received oral inhalation of placebo OD for 14 days +/- 4 days in Period 1, followed by oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Period 2. Sequence 2 participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Period 1 followed by oral inhalation of placebo, OD for 14 days +/- 4 days in Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.
24361|NCT02502734|P2|Participant Flow|Fluticasone Furoate Followed by Placebo|Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 2 participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Treatment Period 1 followed by oral inhalation of placebo, OD for 14 days +/- 4 days in Treatment Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.
24362|NCT02502734|P1|Participant Flow|Placebo Followed by Fluticasone Furoate|Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 1 participants received oral inhalation of placebo OD for 14 days +/- 4 days in Treatment Period 1, followed by oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Treatment Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.
24363|NCT02502734|O2|Outcome|Fluticasone Furoate|Participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days during Period 1 or Period 2
24364|NCT02502734|O1|Outcome|Placebo|Participants received oral inhalation of placebo OD for 14 days +/- 4 days during Period 1 or Period 2
24365|NCT02502734|O2|Outcome|Fluticasone Furoate|Participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days during Period 1 or Period 2.
24366|NCT02502734|O1|Outcome|Placebo|Participants received oral inhalation of placebo OD for 14 days +/- 4 days during Period 1 or Period 2.
24367|NCT02502734|E2|Reported Event|Fluticasone Furoate|Participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days during Period 1 or Period 2
24368|NCT02502734|E1|Reported Event|Placebo|Participants received oral inhalation of placebo OD for 14 days +/- 4 days during Period 1 or Period 2
24369|NCT02502526|B4|Baseline|Total|Total of all reporting groups
24370|NCT02502526|B3|Baseline|IVS MFK|IVS, 45° MFK Tip used with Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
24371|NCT02502526|B2|Baseline|CVS MFK|CVS, 45° MFK Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
24372|NCT02502526|B1|Baseline|CVS Bal|CVS, 45° Balanced Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
24373|NCT02502526|P3|Participant Flow|IVS MFK|lnfiniti® Vision System (IVS), 45° MFK Tip used with Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
24374|NCT02502526|P2|Participant Flow|CVS MFK|CVS, 45° MFK Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
24375|NCT02502526|P1|Participant Flow|CVS Bal|Centurion® Vision System (CVS), 45° Balanced Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
24830|NCT02498652|O2|Outcome|Treatment A2q|Allopurinol 600 mg (qd) (Cohorts 1 and 2)
36455|NCT02389088|O9|Outcome|Phase II - Week 6 - 0 Hours|
24376|NCT02502526|O3|Outcome|IVS MFK|IVS, 45° MFK Tip used with Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
24377|NCT02502526|O2|Outcome|CVS MFK|CVS, 45° MFK Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
24378|NCT02502526|O1|Outcome|CVS Bal|CVS, 45° Balanced Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
24379|NCT02502526|O3|Outcome|IVS MFK|IVS, 45° MFK Tip used with Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
24380|NCT02502526|O2|Outcome|CVS MFK|CVS, 45° MFK Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
24381|NCT02502526|O1|Outcome|CVS Bal|CVS, 45° Balanced Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
24382|NCT02502526|O2|Outcome|IVS MFK|lVS, 45° MFK Tip used with Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
24383|NCT02502526|O1|Outcome|CVS Bal|CVS, 45° Balanced Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
24384|NCT02502526|E3|Reported Event|IVS MFK|Subjects exposed to lVS, 45° MFK Tip
24385|NCT02502526|E2|Reported Event|CVS MFK|Subjects exposed to CVS, 45° MFK Tip
24386|NCT02502526|E1|Reported Event|CVS Bal|Subjects exposed to CVS, 45° Balanced Tip
24387|NCT02502487|B4|Baseline|Total|Total of all reporting groups
24388|NCT02502487|B3|Baseline|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
24389|NCT02502487|B2|Baseline|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
24390|NCT02502487|B1|Baseline|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
24391|NCT02502487|P3|Participant Flow|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
24392|NCT02502487|P2|Participant Flow|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
24393|NCT02502487|P1|Participant Flow|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
24394|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
24395|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
24396|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
24397|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
24398|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
24399|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
24400|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
24461|NCT02502149|P5|Participant Flow|15K rFVIIIFc (6000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24831|NCT02498652|O1|Outcome|Treatment A1|Allopurinol 300 mg qd (Cohorts 1 and 2)
24401|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
24402|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
24403|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
24404|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
24405|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
24406|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
24407|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
24408|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
24409|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
24410|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
24411|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
24412|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
24413|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
24414|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
24415|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
24416|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
24417|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
24418|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
24419|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
24420|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
24832|NCT02498652|O9|Outcome|Treatment R6|Allopurinol 300 mg qd + RDEA3170 20 mg qd (Cohort 2)
24421|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
24422|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
24423|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
24424|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
24425|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
24426|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
24427|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
24428|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
24429|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
24430|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
24431|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
24432|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
24433|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
24434|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
24435|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
24436|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
24437|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
24438|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
24439|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
24462|NCT02502149|P4|Participant Flow|15K rFVIIIFc (1000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24440|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
24441|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
24442|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
24443|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
24444|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
24445|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
24446|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
24447|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
24448|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
24449|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
24450|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
24451|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
24452|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
24453|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
24454|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
24455|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
24456|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
24457|NCT02502487|E3|Reported Event|Combination Group|DPNB with ropivacaine plus tetracaine gel
24458|NCT02502487|E2|Reported Event|DPNB Group|DPNB with ropivacaine plus plain lubricant
24459|NCT02502487|E1|Reported Event|Tetracaine Group|tetracaine gel plus DPNB with saline
24460|NCT02502149|B1|Baseline|2K/15K rFVIIIFc (1000/6000 IU/Vial Strength)- All Participants|All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for PK1. At PK1, participants were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants will resume to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
36456|NCT02389088|O8|Outcome|Phase II - Week 5 - 24 Hours|
24463|NCT02502149|P3|Participant Flow|15K rFVIIIFc (6000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with15K rFVIIIFc, participants will be re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants will resume to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24464|NCT02502149|P2|Participant Flow|15K rFVIIIFc (1000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for pharmacokinetic assessment 2 (PK2). Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with15K rFVIIIFc, participants will be re-evaluated at Pharmacokinetic assessment 3 (PK3) at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants will resume to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24465|NCT02502149|P1|Participant Flow|2K rFVIIIFc (1000 IU/Vial Strength) (PK1)|All participants received recombinant factor VIII Fc fusion protein (rFVIIIFc) (1000 IU/vial strength), 50 International Unit per kilogram (IU/kg), manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1).
24466|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24467|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24468|NCT02502149|O1|Outcome|2K/15K rFVIIIFc (1000/6000 IU/Vial Strength)- All Participants|All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for PK1. At PK1, participants were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24469|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24470|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24471|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24472|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24473|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24474|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24475|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24476|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24477|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24478|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24479|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24480|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24833|NCT02498652|O8|Outcome|Treatment R5|Allopurinol 300 mg qd + RDEA3170 15 mg qd (Cohort 1)
24481|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24482|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24483|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24484|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24485|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24486|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24487|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24488|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24489|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24490|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24491|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24538|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24492|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24493|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24494|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24495|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24496|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24497|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 or 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24498|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24499|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 or 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24500|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24501|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 or 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24502|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24503|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 and 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24654|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
24834|NCT02498652|O7|Outcome|Treatment R4|Allopurinol 300 mg qd + RDEA3170 10 mg qd (Cohort 2)
24504|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24505|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 or 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24506|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24507|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 or 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24508|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24509|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 or 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24510|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24511|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24512|NCT02502149|O1|Outcome|2K rFVIIIFc (1000 IU/Vial Strength) (PK1)|All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1).
24513|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24514|NCT02502149|O1|Outcome|2K rFVIIIFc (1000 IU/Vial Strength) (PK1)|All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1).
24515|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24516|NCT02502149|O1|Outcome|2K rFVIIIFc (1000 IU/Vial Strength) (PK1)|All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1).
24589|NCT02501590|O1|Outcome|Study|"After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child’s dominant hand.~The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing)."
24517|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24518|NCT02502149|O1|Outcome|2K rFVIIIFc (1000 IU/Vial Strength) (PK1)|All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1).
24519|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24520|NCT02502149|O1|Outcome|2K rFVIIIFc (1000 IU/Vial Strength) (PK1)|All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1).
24521|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24522|NCT02502149|O1|Outcome|2K rFVIIIFc (1000 IU/Vial Strength) (PK1)|All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1).
24523|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24524|NCT02502149|O1|Outcome|2K rFVIIIFc (1000 IU/Vial Strength) (PK1)|All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1).
24525|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24526|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24527|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24528|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24529|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24530|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24531|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24532|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24533|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24534|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24535|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24536|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24537|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24539|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24540|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24541|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24542|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24543|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24544|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24545|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24546|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24547|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24548|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
36457|NCT02389088|O7|Outcome|Phase II - Week 5 - 0 Hours|
24549|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24550|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24551|NCT02502149|O2|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24552|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24553|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 or 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24554|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24555|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 or 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24556|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24557|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 or 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24558|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24559|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 or 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24560|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24561|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 or 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
36458|NCT02389088|O6|Outcome|Phase II - Week 0 - 24 Hours|
24562|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24563|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 or 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24564|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24565|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 or 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
24566|NCT02502149|O1|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24567|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24568|NCT02502149|O1|Outcome|2K rFVIIIFc (1000 IU/Vial Strength) (PK1)|All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1).
24569|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24570|NCT02502149|O1|Outcome|2K rFVIIIFc (1000 IU/Vial Strength) (PK1)|All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1).
24571|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24572|NCT02502149|O1|Outcome|2K rFVIIIFc (1000 IU/Vial Strength) (PK1)|All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1).
24573|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24574|NCT02502149|O1|Outcome|2K rFVIIIFc (1000 IU/Vial Strength) (PK1)|All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1).
24590|NCT02501590|E2|Reported Event|Control|"After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child’s dominant hand.~The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing)."
24575|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24576|NCT02502149|O1|Outcome|2K rFVIIIFc (1000 IU/Vial Strength) (PK1)|All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1).
24577|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24578|NCT02502149|O1|Outcome|2K rFVIIIFc (1000 IU/Vial Strength) (PK1)|All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1).
24579|NCT02502149|O2|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for pharmacokinetic assessment 2 (PK2). Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at Pharmacokinetic assessment 3 (PK3) at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24580|NCT02502149|O1|Outcome|2K rFVIIIFc (1000 IU/Vial Strength) (PK1)|All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1).
24581|NCT02502149|E2|Reported Event|15K rFVIIIFc (1000 and 6000 IU/Vial Strength)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
24582|NCT02502149|E1|Reported Event|2K rFVIIIFc (1000 IU/Vial Strength) (PK1)|All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1).
24583|NCT02501590|B3|Baseline|Total|Total of all reporting groups
24584|NCT02501590|B2|Baseline|Control|"After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child’s dominant hand.~The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing)."
24585|NCT02501590|B1|Baseline|Study|"After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child’s dominant hand.~The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing)."
24586|NCT02501590|P2|Participant Flow|Control|"After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child’s dominant hand.~The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing)."
24587|NCT02501590|P1|Participant Flow|Study|"After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child’s dominant hand.~The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing)."
24588|NCT02501590|O2|Outcome|Control|"After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child’s dominant hand.~The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing)."
24633|NCT02500537|P2|Participant Flow|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
24591|NCT02501590|E1|Reported Event|Study|"After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child’s dominant hand.~The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing)."
24592|NCT02500836|B4|Baseline|Total|Total of all reporting groups
24593|NCT02500836|B3|Baseline|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
24594|NCT02500836|B2|Baseline|Cocaine HCI 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
24595|NCT02500836|B1|Baseline|Cocaine HCI 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
24596|NCT02500836|P3|Participant Flow|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
24597|NCT02500836|P2|Participant Flow|Cocaine HCI 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
24598|NCT02500836|P1|Participant Flow|Cocaine HCI 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
24599|NCT02500836|O2|Outcome|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
24600|NCT02500836|O1|Outcome|Cocaine HCI 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
24601|NCT02500836|O2|Outcome|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
24602|NCT02500836|O1|Outcome|Cocaine HCI 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
24603|NCT02500836|E3|Reported Event|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
24604|NCT02500836|E2|Reported Event|Cocaine HCI 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
24605|NCT02500836|E1|Reported Event|Cocaine HCI 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
24606|NCT02500758|B3|Baseline|Total|Total of all reporting groups
24607|NCT02500758|B2|Baseline|Chlorhexidine Digluconate|"Reducing bacterial load after preoperative surgical scrubbing using 4% chlorhexidine digluconate. Both hands have been prepared by preparatory handwash.~Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.~Preparatory handwash follows the UNE-EN 12791 standard."
24608|NCT02500758|B1|Baseline|Parachlorometaxylenol|"Reducing bacterial load after preoperative surgical scrubbing using 3% parachlorometaxylenol. Both hands have been prepared by preparatory handwash.~Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.~Preparatory handwash follows the UNE-EN 12791 standard."
24609|NCT02500758|P2|Participant Flow|Chlorhexidine Digluconate Then Parachlorometaxylenol|"Participants first scrubbed their hands, for 2 minutes, using a sterile disponsable surgical scrub with chlorhexidine digluconato (matching parachlorometaxylenol).~After a washout period of 1 week, to allow reconstruction of the normal skin flora, they then scubbed their hands, for 2 minutes, using a sterile disponsable surgical scrub with parachlorometaxylenol."
24610|NCT02500758|P1|Participant Flow|Parachlorometaxylenol Then Clorhexidine Digluconate|Participants first scrubbed their hands, for 2 minutes, using a sterile disponsable surgical scrub with parachlorometaxylenol After a washout period of 1 week, to allow reconstruction of the normal skin flora, they then scubbed their hands, for 2 minutes, using a sterile disponsable surgical scrub with chlorhexidine digluconato (matching parachlorometaxylenol).
24611|NCT02500758|O2|Outcome|Chlorhexidine Digluconate|"Change in bacterial load after preoperative surgical scrubbing using 4% chlorhexidine digluconate. Both hands have been prepared by preparatory handwash.~Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.~Preparatory handwash follows the UNE-EN 12791 standard."
24612|NCT02500758|O1|Outcome|Parachlorometaxylenol|"Change in bacterial load after preoperative surgical scrubbing using 3% parachlorometaxylenol. Both hands have been prepared by preparatory handwash.~Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.~Preparatory handwash follows the UNE-EN 12791 standard."
24791|NCT02498652|B1|Baseline|Cohort 1|Allopurinol 300 mg once daily (qd), 600 mg qd, RDEA3170 2.5 mg qd, 15 mg qd and 7.5 mg qd
24613|NCT02500758|O2|Outcome|Chlorhexidine Digluconate|"Change in bacterial load after preoperative surgical scrubbing using 4% chlorhexidine digluconate. Both hands have been prepared by preparatory handwash.~Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.~Preparatory handwash follows the UNE-EN 12791 standard."
24614|NCT02500758|O1|Outcome|Parachlorometaxylenol|"Change in bacterial load after preoperative surgical scrubbing using 3% parachlorometaxylenol. Both hands have been prepared by preparatory handwash.~Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.~Preparatory handwash follows the UNE-EN 12791 standard"
24615|NCT02500758|E2|Reported Event|Chlorhexidine Digluconate|"Reducing bacterial load after preoperative surgical scrubbing using 4% chlorhexidine digluconate. Both hands have been prepared by preparatory handwash.~Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.~Preparatory handwash follows the UNE-EN 12791 standard."
24616|NCT02500758|E1|Reported Event|Parachlorometaxylenol|"Reducing bacterial load after preoperative surgical scrubbing using 3% parachlorometaxylenol. Both hands have been prepared by preparatory handwash.~Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.~Preparatory handwash follows the UNE-EN 12791 standard."
24617|NCT02500628|B3|Baseline|Total|Total of all reporting groups
24618|NCT02500628|B2|Baseline|Antipsychotic Use|"Antipsychotic use (subgroups: no side effects, dyskinesia, weight gain) Metformin 500 mg po in AM~Metformin: 500 mg po after baseline testing of heart rate"
24619|NCT02500628|B1|Baseline|Fibromyalgia|"Fibromyalgia (subgroups: opioid responsive, opioid resistant, opioid intolerant) Metformin 500 mg po in AM~Metformin: 500 mg po after baseline testing of heart rate"
24620|NCT02500628|P2|Participant Flow|Antipsychotic Use|"Antipsychotic use (subgroups: no side effects, dyskinesia, weight gain) Metformin 500 mg orally in the morning~Metformin: 500 mg orally after baseline testing of heart rate"
24621|NCT02500628|P1|Participant Flow|Fibromyalgia|"Fibromyalgia (subgroups: opioid responsive, opioid resistant, opioid intolerant) Metformin 500 mg orally in the morning~Metformin: 500 mg orally after baseline testing of heart rate"
24622|NCT02500628|O2|Outcome|Antipsychotic Use|"Antipsychotic use (subgroups: no side effects, dyskinesia, weight gain) Metformin 500 mg po in AM~Metformin: 500 mg po after baseline testing of heart rate"
24623|NCT02500628|O1|Outcome|Fibromyalgia|"Fibromyalgia (subgroups: opioid responsive, opioid resistant, opioid intolerant) Metformin 500 mg po in AM~Metformin: 500 mg po after baseline testing of heart rate"
24624|NCT02500628|O2|Outcome|Antipsychotic Use|"Antipsychotic use (subgroups: no side effects, dyskinesia, weight gain) Metformin 500 mg orally in the morning~Metformin: 500 mg orally after baseline testing of heart rate"
24625|NCT02500628|O1|Outcome|Fibromyalgia|"Fibromyalgia (subgroups: opioid responsive, opioid resistant, opioid intolerant) Metformin 500 mg orally in the morning~Metformin: 500 mg orally after baseline testing of heart rate"
24626|NCT02500628|O2|Outcome|Antipsychotic Use|"Antipsychotic use (subgroups: no side effects, dyskinesia, weight gain) Metformin 500 mg po in AM~Metformin: 500 mg po after baseline testing of heart rate"
24627|NCT02500628|O1|Outcome|Fibromyalgia|"Fibromyalgia (subgroups: opioid responsive, opioid resistant, opioid intolerant) Metformin 500 mg po in AM~Metformin: 500 mg po after baseline testing of heart rate"
24628|NCT02500628|E2|Reported Event|Antipsychotic Use|"Antipsychotic use (subgroups: no side effects, dyskinesia, weight gain) Metformin 500 mg po in AM~Metformin: 500 mg po after baseline testing of heart rate"
24629|NCT02500628|E1|Reported Event|Fibromyalgia|"Fibromyalgia (subgroups: opioid responsive, opioid resistant, opioid intolerant) Metformin 500 mg po in AM~Metformin: 500 mg po after baseline testing of heart rate"
24630|NCT02500537|B3|Baseline|Total|Total of all reporting groups
24631|NCT02500537|B2|Baseline|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
24632|NCT02500537|B1|Baseline|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
24634|NCT02500537|P1|Participant Flow|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
24635|NCT02500537|O2|Outcome|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
24636|NCT02500537|O1|Outcome|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
24637|NCT02500537|O2|Outcome|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
24638|NCT02500537|O1|Outcome|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
24639|NCT02500537|O2|Outcome|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
24640|NCT02500537|O1|Outcome|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
24641|NCT02500537|O1|Outcome|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
24642|NCT02500537|O1|Outcome|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
24643|NCT02500537|O2|Outcome|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
24644|NCT02500537|O1|Outcome|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
24645|NCT02500537|O2|Outcome|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
24646|NCT02500537|O1|Outcome|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
24647|NCT02500537|O2|Outcome|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
24648|NCT02500537|O1|Outcome|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
24649|NCT02500537|E2|Reported Event|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
24650|NCT02500537|E1|Reported Event|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
24651|NCT02500368|B1|Baseline|Overall Baseline Characteristics|Participants were randomized to wear silicone hydrogel lens (test) or enfilcon A lens (control) for 1 week during the cross over study.
24652|NCT02500368|P2|Participant Flow|Enfilcon A Lens (Control), Then Silicone Hydrogel Lens (Test)|"Participants were randomized to wear enfilcon A lens (control) for 1 week, then cross over to the silicone hydrogel lens (test).~enfilcon A lens (control): contact lens~silicone hydrogel lens (test): contact lens"
24653|NCT02500368|P1|Participant Flow|Silicone Hydrogel Lens (Test), Then Enfilcon A Lens (Control)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week, then cross over to the enfilcon A lens (control).~silicone hydrogel lens (test): contact lens~enfilcon A lens (control): contact lens"
24792|NCT02498652|P2|Participant Flow|Cohort 2|Allopurinol 300 mg qd, 600 mg (300 mg bid), RDEA3170 5 mg qd, 20 mg qd and 10 mg qd
24655|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
24656|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
24657|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
24658|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
24659|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
24660|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
24661|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
24662|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
24663|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
24664|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
24665|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
24666|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
24667|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
24668|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
24669|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
24670|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
24671|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
24672|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
24673|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
24674|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
24675|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
24676|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
24677|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
24678|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
24679|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
24680|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
24681|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
24682|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
24683|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
24684|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
24685|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
24686|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
24687|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
24688|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
24689|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
24690|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
24691|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
24692|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
24693|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
24694|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
24695|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
24696|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
24697|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
24698|NCT02500368|E2|Reported Event|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
24699|NCT02500368|E1|Reported Event|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
24700|NCT02500056|B3|Baseline|Total|Total of all reporting groups
24701|NCT02500056|B2|Baseline|UM Group|"Ultrapro mesh~Ultrapro mesh: Lichtenstein hernioplasty"
24702|NCT02500056|B1|Baseline|OM Group|"Optilene LP mesh~Optilene LP mesh: Lichtenstein hernioplasty"
24703|NCT02500056|P2|Participant Flow|UM Group|"Ultrapro mesh~Ultrapro mesh: Lichtenstein hernioplasty"
24704|NCT02500056|P1|Participant Flow|OM Group|"Optilene LP mesh~Optilene LP mesh: Lichtenstein hernioplasty"
24705|NCT02500056|O2|Outcome|UM Group|"Ultrapro mesh~Ultrapro mesh: Lichtenstein hernioplasty"
24706|NCT02500056|O1|Outcome|OM Group|"Optilene LP mesh~Optilene LP mesh: Lichtenstein hernioplasty"
24707|NCT02500056|O2|Outcome|UM Group|"Ultrapro mesh~Ultrapro mesh: Lichtenstein hernioplasty"
24708|NCT02500056|O1|Outcome|OM Group|"Optilene LP mesh~Optilene LP mesh: Lichtenstein hernioplasty"
24709|NCT02500056|O2|Outcome|UM Group|"Ultrapro mesh~Ultrapro mesh: Lichtenstein hernioplasty"
24710|NCT02500056|O1|Outcome|OM Group|"Optilene LP mesh~Optilene LP mesh: Lichtenstein hernioplasty"
24711|NCT02500056|E2|Reported Event|UM Group|"Ultrapro mesh~Ultrapro mesh: Lichtenstein hernioplasty"
24712|NCT02500056|E1|Reported Event|OM Group|"Optilene LP mesh~Optilene LP mesh: Lichtenstein hernioplasty"
24713|NCT02499952|B1|Baseline|Experimental Arm|"Pembrolizumab~Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy."
24714|NCT02499952|P1|Participant Flow|Experimental Arm|"Pembrolizumab~Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy."
24715|NCT02499952|O1|Outcome|Experimental Arm|"Pembrolizumab~Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy."
24716|NCT02499952|O1|Outcome|Experimental Arm|"Pembrolizumab~Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy."
24717|NCT02499952|O1|Outcome|Experimental Arm|"Pembrolizumab~Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy."
24718|NCT02499952|O1|Outcome|Experimental Arm|"Pembrolizumab~Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy."
24719|NCT02499952|E1|Reported Event|Experimental Arm|"Pembrolizumab~Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy."
24720|NCT02499692|B1|Baseline|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
24721|NCT02499692|P1|Participant Flow|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
24722|NCT02499692|O1|Outcome|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
24723|NCT02499692|O1|Outcome|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
24724|NCT02499692|O1|Outcome|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
24725|NCT02499692|O1|Outcome|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
24726|NCT02499692|O1|Outcome|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
24727|NCT02499692|O1|Outcome|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
24728|NCT02499692|E1|Reported Event|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
24729|NCT02499575|B3|Baseline|Total|Total of all reporting groups
24730|NCT02499575|B2|Baseline|Regional Block Plus Exparel|"Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine~Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)"
24731|NCT02499575|B1|Baseline|Regional Block|"Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine"
24732|NCT02499575|P2|Participant Flow|Regional Block Plus Exparel|"Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine~Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)"
24733|NCT02499575|P1|Participant Flow|Regional Block|"Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine"
24734|NCT02499575|O2|Outcome|Regional Block Plus Exparel|"Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine~Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)"
24735|NCT02499575|O1|Outcome|Regional Block|"Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine"
24736|NCT02499575|O2|Outcome|Regional Block Plus Exparel|"Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine~Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)"
24737|NCT02499575|O1|Outcome|Regional Block|"Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine"
24738|NCT02499575|O2|Outcome|Regional Block Plus Exparel|"Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine~Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)"
24739|NCT02499575|O1|Outcome|Regional Block|"Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine"
24740|NCT02499575|E2|Reported Event|Regional Block Plus Exparel|"Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine~Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)"
24741|NCT02499575|E1|Reported Event|Regional Block|"Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine"
24742|NCT02498821|B3|Baseline|Total|Total of all reporting groups
24743|NCT02498821|B2|Baseline|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24744|NCT02498821|B1|Baseline|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24793|NCT02498652|P1|Participant Flow|Cohort 1|Allopurinol 300 mg once daily (qd), 600 mg qd, RDEA3170 2.5 mg qd, 15 mg qd and 7.5 mg qd
24794|NCT02498652|O6|Outcome|Treatment R6|Allopurinol 300 mg qd + RDEA3170 20 mg qd
36459|NCT02389088|O5|Outcome|Phase I - Week 6 - 24 Hour|
24745|NCT02498821|P2|Participant Flow|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® Tip Confirmation System (TCS) magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24746|NCT02498821|P1|Participant Flow|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24747|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24748|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24749|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24750|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24751|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24752|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24753|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24754|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24795|NCT02498652|O5|Outcome|Treatment R4|Allopurinol 300 mg qd + RDEA3170 10 mg qd
24796|NCT02498652|O4|Outcome|Treatment R2|Allopurinol 300 mg qd + RDEA3170 5 mg qd
24797|NCT02498652|O3|Outcome|Treatment A2b|Allopurinol 600 mg (300 mg bid)
24755|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24756|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24757|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24758|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24759|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24760|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24761|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24762|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24763|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24764|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24798|NCT02498652|O2|Outcome|Treatment A2q|Allopurinol 600 mg qd
24799|NCT02498652|O1|Outcome|Treatment A1|Allopurinol 300 mg qd
24800|NCT02498652|O6|Outcome|Treatment R6|Allopurinol 300 mg qd + RDEA3170 20 mg qd
36460|NCT02389088|O4|Outcome|Phase I - Week 6 - 0 Hour|
24765|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24766|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24767|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24768|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24769|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24770|NCT02498821|E2|Reported Event|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24771|NCT02498821|E1|Reported Event|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
24772|NCT02498678|B3|Baseline|Total|Total of all reporting groups
24773|NCT02498678|B2|Baseline|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
24774|NCT02498678|B1|Baseline|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
24775|NCT02498678|P2|Participant Flow|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
24776|NCT02498678|P1|Participant Flow|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
24777|NCT02498678|O2|Outcome|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
24778|NCT02498678|O1|Outcome|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
24779|NCT02498678|O2|Outcome|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
24780|NCT02498678|O1|Outcome|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
24781|NCT02498678|O2|Outcome|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
24782|NCT02498678|O1|Outcome|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
24783|NCT02498678|O2|Outcome|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
24784|NCT02498678|O1|Outcome|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
24785|NCT02498678|O2|Outcome|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
24786|NCT02498678|O1|Outcome|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
24787|NCT02498678|E2|Reported Event|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
24788|NCT02498678|E1|Reported Event|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
24789|NCT02498652|B3|Baseline|Total|Total of all reporting groups
24790|NCT02498652|B2|Baseline|Cohort 2|Allopurinol 300 mg qd, 600 mg (300 mg bid), RDEA3170 5 mg qd, 20 mg qd and 10 mg qd
24837|NCT02498652|O4|Outcome|Treatment R1|Allopurinol 300 mg qd + RDEA3170 2.5 mg qd (Cohort 1)
24838|NCT02498652|O3|Outcome|Treatment A2b|Allopurinol 600 mg (300 mg bid) (Cohorts 1 and 2)
24839|NCT02498652|O2|Outcome|Treatment A2q|Allopurinol 600 mg (qd) (Cohorts 1 and 2)
24840|NCT02498652|O1|Outcome|Treatment A1|Allopurinol 300 mg qd (Cohorts 1 and 2)
24841|NCT02498652|O9|Outcome|Treatment R6|Allopurinol 300 mg qd + RDEA3170 20 mg qd (Cohort 2)
24842|NCT02498652|O8|Outcome|Treatment R5|Allopurinol 300 mg qd + RDEA3170 15 mg qd (Cohort 1)
24843|NCT02498652|O7|Outcome|Treatment R4|Allopurinol 300 mg qd + RDEA3170 10 mg qd (Cohort 2)
24844|NCT02498652|O6|Outcome|Treatment R3|Allopurinol 300 mg qd + RDEA3170 7.5 mg qd (Cohort 1)
24845|NCT02498652|O5|Outcome|Treatment R2|Allopurinol 300 mg qd + RDEA3170 5 mg qd (Cohort 2)
24846|NCT02498652|O4|Outcome|Treatment R1|Allopurinol 300 mg qd + RDEA3170 2.5 mg qd (Cohort 1)
24847|NCT02498652|O3|Outcome|Treatment A2b|Allopurinol 600 mg (300 mg bid) (Cohorts 1 and 2)
24848|NCT02498652|O2|Outcome|Treatment A2q|Allopurinol 600 mg (qd) (Cohorts 1 and 2)
24849|NCT02498652|O1|Outcome|Treatment A1|Allopurinol 300 mg qd (Cohorts 1 and 2)
24850|NCT02498652|O9|Outcome|Treatment R6|Allopurinol 300 mg qd + RDEA3170 20 mg qd (Cohort 2)
24851|NCT02498652|O8|Outcome|Treatment R5|Allopurinol 300 mg qd + RDEA3170 15 mg qd (Cohort 1)
24852|NCT02498652|O7|Outcome|Treatment R4|Allopurinol 300 mg qd + RDEA3170 10 mg qd (Cohort 2)
24853|NCT02498652|O6|Outcome|Treatment R3|Allopurinol 300 mg qd + RDEA3170 7.5 mg qd (Cohort 1)
24854|NCT02498652|O5|Outcome|Treatment R2|Allopurinol 300 mg qd + RDEA3170 5 mg qd (Cohort 2)
24855|NCT02498652|O4|Outcome|Treatment R1|Allopurinol 300 mg qd + RDEA3170 2.5 mg qd (Cohort 1)
24856|NCT02498652|O3|Outcome|Treatment A2b|Allopurinol 600 mg (300 mg bid) (Cohorts 1 and 2)
24857|NCT02498652|O2|Outcome|Treatment A2q|Allopurinol 600 mg (qd) (Cohorts 1 and 2)
24858|NCT02498652|O1|Outcome|Treatment A1|Allopurinol 300 mg qd (Cohorts 1 and 2)
24859|NCT02498652|O6|Outcome|Treatment R6|Allopurinol 300 mg qd + RDEA3170 20 mg qd
24860|NCT02498652|O5|Outcome|Treatment R4|Allopurinol 300 mg qd + RDEA3170 10 mg qd
24861|NCT02498652|O4|Outcome|Treatment R2|Allopurinol 300 mg qd + RDEA3170 5 mg qd
24862|NCT02498652|O3|Outcome|Treatment A2b|Allopurinol 600 mg (300 mg bid)
24863|NCT02498652|O2|Outcome|Treatment A2q|Allopurinol 600 mg qd
24864|NCT02498652|O1|Outcome|Treatment A1|Allopurinol 300 mg qd
24865|NCT02498652|O6|Outcome|Treatment R5|Allopurinol 300 mg qd + RDEA3170 15 mg qd
24866|NCT02498652|O5|Outcome|Treatment R3|Allopurinol 300 mg qd + RDEA3170 7.5 mg qd
24867|NCT02498652|O4|Outcome|Treatment R1|Allopurinol 300 mg qd + RDEA3170 2.5 mg qd
24868|NCT02498652|O3|Outcome|Treatment A2b|Allopurinol 600 mg (300 mg bid)
24869|NCT02498652|O2|Outcome|Treatment A2q|Allopurinol 600 mg qd
24870|NCT02498652|O1|Outcome|Treatment A1|Allopurinol 300 mg qd
24871|NCT02498652|O6|Outcome|Treatment R5|Allopurinol 300 mg qd + RDEA3170 15 mg qd
24872|NCT02498652|O5|Outcome|Treatment R3|Allopurinol 300 mg qd + RDEA3170 7.5 mg qd
24873|NCT02498652|O4|Outcome|Treatment R1|Allopurinol 300 mg qd + RDEA3170 2.5 mg qd
24874|NCT02498652|O3|Outcome|Treatment A2b|Allopurinol 600 mg (300 mg bid)
24875|NCT02498652|O2|Outcome|Treatment A2q|Allopurinol 600 mg qd
24876|NCT02498652|O1|Outcome|Treatment A1|Allopurinol 300 mg qd
24877|NCT02498652|O6|Outcome|Treatment R5|Allopurinol 300 mg qd + RDEA3170 15 mg qd
24878|NCT02498652|O5|Outcome|Treatment R3|Allopurinol 300 mg qd + RDEA3170 7.5 mg qd
24879|NCT02498652|O4|Outcome|Treatment R1|Allopurinol 300 mg qd + RDEA3170 2.5 mg qd
24880|NCT02498652|O3|Outcome|Treatment A2b|Allopurinol 600 mg (300 mg bid)
24881|NCT02498652|O2|Outcome|Treatment A2q|Allopurinol 600 mg qd
24882|NCT02498652|O1|Outcome|Treatment A1|Allopurinol 300 mg qd
24883|NCT02498652|O6|Outcome|Treatment R5|Allopurinol 300 mg qd + RDEA3170 15 mg qd
24884|NCT02498652|O5|Outcome|Treatment R3|Allopurinol 300 mg qd + RDEA3170 7.5 mg qd
24885|NCT02498652|O4|Outcome|Treatment R1|Allopurinol 300 mg qd + RDEA3170 2.5 mg qd
24886|NCT02498652|O3|Outcome|Treatment A2b|Allopurinol 600 mg (300 mg bid)
24887|NCT02498652|O2|Outcome|Treatment A2q|Allopurinol 600 mg qd
24888|NCT02498652|O1|Outcome|Treatment A1|Allopurinol 300 mg qd
24889|NCT02498652|E2|Reported Event|Cohort 2|RDEA3170 5 mg, 10 mg 20 mg qd in combination with allopurinol 300 mg (qd and bid)
24890|NCT02498652|E1|Reported Event|Cohort 1|RDEA3170 2.5 mg, 7.5 mg and 15 mg qd in combination with allopurinol 300 mg (qd and bid)
24891|NCT02498522|B3|Baseline|Total|Total of all reporting groups
24892|NCT02498522|B2|Baseline|Control Arm|"83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
24893|NCT02498522|B1|Baseline|Metformin Arm|"83 patients will continue metformin until end of 1st trimester (14 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
24894|NCT02498522|P2|Participant Flow|Control Arm|"83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
24895|NCT02498522|P1|Participant Flow|Metformin Arm|"83 patients will continue metformin until end of 1st trimester (14 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
24896|NCT02498522|O2|Outcome|Control Arm|"83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
24897|NCT02498522|O1|Outcome|Metformin Arm|"83 patients will continue metformin until end of 1st trimester (14 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
24898|NCT02498522|E2|Reported Event|Control Arm|"83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
24899|NCT02498522|E1|Reported Event|Metformin Arm|"83 patients will continue metformin until end of 1st trimester (14 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
24902|NCT02497976|B1|Baseline|Certolizumab Pegol|Experimental drug certolizumab pegol 400mg.
24903|NCT02497976|P2|Participant Flow|Group 2: Placebo Comparator|"Placebo: given subcutaneously at week 0, 2, 4, and week 8~Placebo: Normal saline"
24904|NCT02497976|P1|Participant Flow|Group 1: Experimental|"Biological: Certolizumab pegol (Cimzia) 400 mg loading dose given subcutaneously at week 0, 2, and 4 followed by a maintenance dose at week 8~Certolizumab pegol: 400 mg"
24905|NCT02497976|O2|Outcome|Group 2: Placebo Comparator|"Placebo: given subcutaneously at week 0, 2, 4, and week 8~Placebo: Normal saline"
24906|NCT02497976|O1|Outcome|Group 1: Experimental|"Biological: Certolizumab pegol (Cimzia) 400 mg loading dose given subcutaneously at week 0, 2, and 4 followed by a maintenance dose at week 8~Certolizumab pegol: 400 mg"
24907|NCT02497976|O2|Outcome|Group 2: Placebo Comparator|"Placebo: given subcutaneously at week 0, 2, 4, and week 8~Placebo: Normal saline"
24908|NCT02497976|O1|Outcome|Group 1: Experimental|"Biological: Certolizumab pegol (Cimzia) 400 mg loading dose given subcutaneously at week 0, 2, and 4 followed by a maintenance dose at week 8~Certolizumab pegol: 400 mg"
24909|NCT02497976|O2|Outcome|Group 2: Placebo Comparator|"Placebo: given subcutaneously at week 0, 2, 4, and week 8~Placebo: Normal saline"
24910|NCT02497976|O1|Outcome|Group 1: Experimental|"Biological: Certolizumab pegol (Cimzia) 400 mg loading dose given subcutaneously at week 0, 2, and 4 followed by a maintenance dose at week 8~Certolizumab pegol: 400 mg"
24911|NCT02497976|O2|Outcome|Group 2: Placebo Comparator|"Placebo: given subcutaneously at week 0, 2, 4, and week 8~Placebo: Normal saline"
24912|NCT02497976|O1|Outcome|Group 1: Experimental|"Biological: Certolizumab pegol (Cimzia) 400 mg loading dose given subcutaneously at week 0, 2, and 4 followed by a maintenance dose at week 8~Certolizumab pegol: 400 mg"
24913|NCT02497976|O2|Outcome|Group 2: Placebo Comparator|"Placebo: given subcutaneously at week 0, 2, 4, and week 8~Placebo: Normal saline"
24914|NCT02497976|O1|Outcome|Group 1: Experimental|"Biological: Certolizumab pegol (Cimzia) 400 mg loading dose given subcutaneously at week 0, 2, and 4 followed by a maintenance dose at week 8~Certolizumab pegol: 400 mg"
24915|NCT02497976|O2|Outcome|Group 2: Placebo Comparator|"Placebo: given subcutaneously at week 0, 2, 4, and week 8~Placebo: Normal saline"
24916|NCT02497976|O1|Outcome|Group 1: Experimental|"Biological: Certolizumab pegol (Cimzia) 400 mg loading dose given subcutaneously at week 0, 2, and 4 followed by a maintenance dose at week 8~Certolizumab pegol: 400 mg"
24917|NCT02497976|E2|Reported Event|Group 2: Placebo Comparator|"Placebo: given subcutaneously at week 0, 2, 4, and week 8~Placebo: Normal saline"
24918|NCT02497976|E1|Reported Event|Group 1: Experimental|"Biological: Certolizumab pegol (Cimzia) 400 mg loading dose given subcutaneously at week 0, 2, and 4 followed by a maintenance dose at week 8~Certolizumab pegol: 400 mg"
24919|NCT02497781|B3|Baseline|Total|Total of all reporting groups
24920|NCT02497781|B2|Baseline|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24921|NCT02497781|B1|Baseline|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24922|NCT02497781|P2|Participant Flow|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24923|NCT02497781|P1|Participant Flow|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24924|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24925|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24926|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
25145|NCT02495831|O1|Outcome|Diclofenac Sodium|"Diclofenac sodium 50 mg oral tablets, single dose~Diclofenac sodium: Diclofenac sodium 50 mg single dose"
24927|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24928|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24929|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24930|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24931|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24932|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24933|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24934|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24935|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24936|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24937|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24938|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
25008|NCT02497235|P2|Participant Flow|TAK-935 100 mg|TAK-935 100 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
24939|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24940|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24941|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24942|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24943|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24944|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24945|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24946|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24947|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24948|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24949|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24950|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
25009|NCT02497235|P1|Participant Flow|TAK-935 50 mg|TAK-935 50 mg, solution, orally, once on Day 1 and up to 370 MBq (10 mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
36461|NCT02389088|O3|Outcome|Phase I - Week 5 - 24 Hour|
24951|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24952|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24953|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24954|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24955|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24956|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24957|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24958|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24959|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24960|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24961|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24987|NCT02497755|P1|Participant Flow|Patient Mobile App Users|Participants installed an app on their smartphone to add to their treatment for depression and/or anxiety. This smartphone app sent psychoeducation and reminders to patients to complete self-report data, collected passive data, and provided aggregated information to a provider dashboard. Participants used the app for at least 4 weeks, with the option to continue use for up to 12 weeks. After 4 weeks, the research coordinator conducted a phone interview on satisfaction with the app.
25395|NCT02492763|O2|Outcome|MK-8521 300 μg|Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
24962|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24963|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24964|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24965|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24966|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24967|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24968|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24969|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24970|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24971|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24972|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24973|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
25006|NCT02497235|P4|Participant Flow|TAK-935 300 mg|TAK-935 300 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
24974|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24975|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24976|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24977|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24978|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24979|NCT02497781|O2|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24980|NCT02497781|O1|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24981|NCT02497781|E2|Reported Event|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24982|NCT02497781|E1|Reported Event|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
24983|NCT02497755|B3|Baseline|Total|Total of all reporting groups
24984|NCT02497755|B2|Baseline|Care Manager Dashboard User|The care manager for the patients participating in this study used an online dashboard to monitor patient usage and responses to mobile app assessments (such as the PHQ-9) as part of her clinical workflow. She used this dashboard for the duration of participant involvement in the study (from 6/25/2015 through 9/30/2015).
24985|NCT02497755|B1|Baseline|Patient Mobile App Users|Participants installed an app for smartphone to add to their treatment for depression and/or anxiety. This smartphone app sent psychoeducation and reminders to patients to complete self-report data, collected passive data, and provided aggregated information to a provider dashboard. Participants used the app for at least 4 weeks, with the option to continue use for up to 12 weeks. After 4 weeks, the research coordinator conducted a phone interview on satisfaction with the app.
24986|NCT02497755|P2|Participant Flow|Care Manager Dashboard User|The care manager for the patients participating in this study used an online dashboard to monitor patient usage and responses to mobile app assessments (such as the PHQ-9) as part of her clinical workflow. She used this dashboard for the duration of participant involvement in the study (from 6/25/2015 through 9/30/2015).
25007|NCT02497235|P3|Participant Flow|TAK-935 200 mg|TAK-935 200 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
25250|NCT02494076|O2|Outcome|Standard Care|"Patients randomized to the control arm will receive first-line therapies and standard therapy.~Standard Care"
24988|NCT02497755|O1|Outcome|Patient Mobile App Users|Participants installed an app for smartphone to add to their treatment for depression and/or anxiety. This smartphone app sent psychoeducation and reminders to patients to complete self-report data, collected passive data, and provided aggregated information to a provider dashboard. Participants used the app for at least 4 weeks, with the option to continue use for up to 12 weeks. After 4 weeks, the research coordinator conducted a phone interview on satisfaction with the app.
24989|NCT02497755|O1|Outcome|Patient Mobile App Users|Participants installed an app for smartphone to add to their treatment for depression and/or anxiety. This smartphone app sent psychoeducation and reminders to patients to complete self-report data, collected passive data, and provided aggregated information to a provider dashboard. Participants used the app for at least 4 weeks, with the option to continue use for up to 12 weeks. After 4 weeks, the research coordinator conducted a phone interview on satisfaction with the app.
24990|NCT02497755|O1|Outcome|Patient Mobile App Users|Participants installed an app on their smartphone to add to their treatment for depression and/or anxiety. This smartphone app sent psychoeducation and reminders to patients to complete self-report data, collected passive data, and provided aggregated information to a provider dashboard. Participants used the app for at least 4 weeks, with the option to continue use for up to 12 weeks. After 4 weeks, the research coordinator conducted a phone interview on satisfaction with the app.
24991|NCT02497755|O1|Outcome|Patient Mobile App Users|Participants installed an app for smartphone to add to their treatment for depression and/or anxiety. This smartphone app sent psychoeducation and reminders to patients to complete self-report data, collected passive data, and provided aggregated information to a provider dashboard. Participants used the app for at least 4 weeks, with the option to continue use for up to 12 weeks. After 4 weeks, the research coordinator conducted a phone interview on satisfaction with the app.
24992|NCT02497755|O1|Outcome|Patient Mobile App Users|Participants installed an app for smartphone to add to their treatment for depression and/or anxiety. This smartphone app sent psychoeducation and reminders to patients to complete self-report data, collected passive data, and provided aggregated information to a provider dashboard. Participants used the app for at least 4 weeks, with the option to continue use for up to 12 weeks. After 4 weeks, the research coordinator conducted a phone interview on satisfaction with the app.
24993|NCT02497755|O1|Outcome|Care Manager Dashboard User|The care manager for the patients participating in this study used an online dashboard to monitor patient usage and responses to mobile app assessments (such as the PHQ-9) as part of her clinical workflow. She used this dashboard for the duration of participant involvement in the study (from 6/25/2015 through 9/30/2015).
24994|NCT02497755|O1|Outcome|Patient Mobile App Users|Participants installed an app for smartphone to add to their treatment for depression and/or anxiety. This smartphone app sent psychoeducation and reminders to patients to complete self-report data, collected passive data, and provided aggregated information to a provider dashboard. Participants used the app for at least 4 weeks, with the option to continue use for up to 12 weeks. After 4 weeks, the research coordinator conducted a phone interview on satisfaction with the app.
24995|NCT02497755|O1|Outcome|Care Manager Dashboard User|The care manager for the patients participating in this study used an online dashboard to monitor patient usage and responses to mobile app assessments (such as the PHQ-9) as part of her clinical workflow. She used this dashboard for the duration of participant involvement in the study (from 6/25/2015 through 9/30/2015).
24996|NCT02497755|O1|Outcome|Patient Mobile App Users|Participants installed an app for smartphone to add to their treatment for depression and/or anxiety. This smartphone app sent psychoeducation and reminders to patients to complete self-report data, collected passive data, and provided aggregated information to a provider dashboard. Participants used the app for at least 4 weeks, with the option to continue use for up to 12 weeks. After 4 weeks, the research coordinator conducted a phone interview on satisfaction with the app.
24997|NCT02497755|E2|Reported Event|Care Manager Dashboard User|The care manager for the patients participating in this study used an online dashboard to monitor patient usage and responses to mobile app assessments (such as the PHQ-9) as part of her clinical workflow. She used this dashboard for the duration of participant involvement in the study (from 6/25/2015 through 9/30/2015).
24998|NCT02497755|E1|Reported Event|Patient Mobile App Users|Participants installed an app for smartphone to add to their treatment for depression and/or anxiety. This smartphone app sent psychoeducation and reminders to patients to complete self-report data, collected passive data, and provided aggregated information to a provider dashboard. Participants used the app for at least 4 weeks, with the option to continue use for up to 12 weeks. After 4 weeks, the research coordinator conducted a phone interview on satisfaction with the app.
24999|NCT02497235|B6|Baseline|Total|Total of all reporting groups
25000|NCT02497235|B5|Baseline|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants and at Baseline, 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later.
25001|NCT02497235|B4|Baseline|TAK-935 300 mg|TAK-935 300 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
25002|NCT02497235|B3|Baseline|TAK-935 200 mg|TAK-935 200 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
25003|NCT02497235|B2|Baseline|TAK-935 100 mg|TAK-935 100 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
25004|NCT02497235|B1|Baseline|TAK-935 50 mg|TAK-935 50 mg, solution, orally, once on Day 1 and up to 370 MBq (10 mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
25005|NCT02497235|P5|Participant Flow|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants and at Baseline, 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later.
25396|NCT02492763|O1|Outcome|MK-8521 180 μg|Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
25010|NCT02497235|O5|Outcome|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants and at Baseline, 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later.
25011|NCT02497235|O4|Outcome|TAK-935 300 mg|TAK-935 300 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
25012|NCT02497235|O3|Outcome|TAK-935 200 mg|TAK-935 200 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
25013|NCT02497235|O2|Outcome|TAK-935 100 mg|TAK-935 100 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
25014|NCT02497235|O1|Outcome|TAK-935 50 mg|TAK-935 50 mg, solution, orally, once on Day 1 and up to 370 MBq (10 mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
25015|NCT02497235|O5|Outcome|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants and at Baseline, 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later.
25016|NCT02497235|O4|Outcome|TAK-935 300 mg|TAK-935 300 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
25017|NCT02497235|O3|Outcome|TAK-935 200 mg|TAK-935 200 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
25018|NCT02497235|O2|Outcome|TAK-935 100 mg|TAK-935 100 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
25019|NCT02497235|O1|Outcome|TAK-935 50 mg|TAK-935 50 mg, solution, orally, once on Day 1 and up to 370 MBq (10 mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
25020|NCT02497235|O5|Outcome|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later.
25021|NCT02497235|O4|Outcome|TAK-935 300 mg|TAK-935 300 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
25022|NCT02497235|O3|Outcome|TAK-935 200 mg|TAK-935 200 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
25023|NCT02497235|O2|Outcome|TAK-935 100 mg|TAK-935 100 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
25024|NCT02497235|O1|Outcome|TAK-935 50 mg|TAK-935 50 mg, solution, orally, once on Day 1 and up to 370 MBq (10 mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
25025|NCT02497235|O1|Outcome|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants.
25026|NCT02497235|O5|Outcome|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later.
25027|NCT02497235|O4|Outcome|TAK-935 300 mg|TAK-935 300 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
25028|NCT02497235|O3|Outcome|TAK-935 200 mg|TAK-935 200 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
25029|NCT02497235|O2|Outcome|TAK-935 100 mg|TAK-935 100 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
25030|NCT02497235|O1|Outcome|TAK-935 50 mg|TAK-935 50 mg, solution, orally, once on Day 1 and up to 370 MBq (10 mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
25031|NCT02497235|O1|Outcome|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants.
25032|NCT02497235|E6|Reported Event|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants and at 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later.
25033|NCT02497235|E5|Reported Event|TAK-935 300 mg|TAK-935 300 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
25034|NCT02497235|E4|Reported Event|TAK-935 200 mg|TAK-935 200 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
25252|NCT02494076|E2|Reported Event|Standard Care|"Patients randomized to the control arm will receive first-line therapies and standard therapy.~Standard Care"
25035|NCT02497235|E3|Reported Event|TAK-935 100 mg|TAK-935 100 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
25036|NCT02497235|E2|Reported Event|TAK-935 50 mg|TAK-935 50 mg, solution, orally, once on Day 1 and up to 370 MBq (10 mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
25037|NCT02497235|E1|Reported Event|Baseline [18F]MNI-792|[18F]MNI-792 up to 370 MBq (10mCi) with a mass of up to 5 mcg, injection, intravenously, prior to Positron Emission Tomography (PET) imaging at Baseline.
25038|NCT02497040|B4|Baseline|Total|Total of all reporting groups
25039|NCT02497040|B3|Baseline|Bupivacaine|"20 ml of 0.5% levobupivacaine saline as a placebo~Bupivacaine: local injection~placebo: local injection"
25040|NCT02497040|B2|Baseline|Levobupivacaine|"20 ml of 0.5% levobupivacaine saline as a placebo~Levobupivacaine: local injection~placebo: local injection"
25041|NCT02497040|B1|Baseline|Bupivacaine,Levobupivacaine|"20 ml of 0.5% bupivacaine 20 ml of 0.5% levobupivacaine~Levobupivacaine: local injection~Bupivacaine: local injection"
25042|NCT02497040|P3|Participant Flow|Bupivacaine|"20 ml of 0.5% levobupivacaine saline as a placebo~Bupivacaine: local injection~placebo: local injection"
25043|NCT02497040|P2|Participant Flow|Levobupivacaine|"20 ml of 0.5% levobupivacaine saline as a placebo~Levobupivacaine: local injection~placebo: local injection"
25044|NCT02497040|P1|Participant Flow|Bupivacaine,Levobupivacaine|"20 ml of 0.5% bupivacaine 20 ml of 0.5% levobupivacaine~Levobupivacaine: local injection~Bupivacaine: local injection"
25045|NCT02497040|O3|Outcome|Bupivacaine|"20 ml of 0.5% levobupivacaine saline as a placebo~Bupivacaine: local injection~placebo: local injection"
25046|NCT02497040|O2|Outcome|Levobupivacaine|"20 ml of 0.5% levobupivacaine saline as a placebo~Levobupivacaine: local injection~placebo: local injection"
25047|NCT02497040|O1|Outcome|Bupivacaine,Levobupivacaine|"20 ml of 0.5% bupivacaine 20 ml of 0.5% levobupivacaine~Levobupivacaine: local injection~Bupivacaine: local injection"
25048|NCT02497040|E3|Reported Event|Bupivacaine|"20 ml of 0.5% levobupivacaine saline as a placebo~Bupivacaine: local injection~placebo: local injection"
25049|NCT02497040|E2|Reported Event|Levobupivacaine|"20 ml of 0.5% levobupivacaine saline as a placebo~Levobupivacaine: local injection~placebo: local injection"
25050|NCT02497040|E1|Reported Event|Bupivacaine,Levobupivacaine|"20 ml of 0.5% bupivacaine 20 ml of 0.5% levobupivacaine~Levobupivacaine: local injection~Bupivacaine: local injection"
25051|NCT02496533|B3|Baseline|Total|Total of all reporting groups
25052|NCT02496533|B2|Baseline|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
25053|NCT02496533|B1|Baseline|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.~Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
25054|NCT02496533|P2|Participant Flow|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
25055|NCT02496533|P1|Participant Flow|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.~Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
25056|NCT02496533|O2|Outcome|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
25057|NCT02496533|O1|Outcome|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.~Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
25058|NCT02496533|O2|Outcome|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
25059|NCT02496533|O1|Outcome|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.~Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
25060|NCT02496533|O2|Outcome|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
25082|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25389|NCT02492763|O4|Outcome|Liraglutide 1.8 mg|Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
25061|NCT02496533|O1|Outcome|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.~Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
25062|NCT02496533|O2|Outcome|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
25063|NCT02496533|O1|Outcome|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.~Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
25064|NCT02496533|E2|Reported Event|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
25065|NCT02496533|E1|Reported Event|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.~Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
25066|NCT02496221|B1|Baseline|Albiglutide 50 mg and Placebo|In a total of two treatment periods, participants received Albiglutide 50 mg (A) and Placebo (P) (in a sequence of either A-P or P-A), each administered subcutaneously as a single dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in each period.
25067|NCT02496221|P2|Participant Flow|Placebo Followed by Albiglutide 50 mg|Participants received Placebo in Treatment Period 1 and Albiglutide 50 mg in Treatment Period 2, each administered subcutaneously as a single dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in each period.
25068|NCT02496221|P1|Participant Flow|Albiglutide 50 mg Followed by Placebo|Participants received Albiglutide 50 milligrams (mg) in Treatment Period 1 and Placebo in Treatment Period 2, each administered subcutaneously as a single dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in each period.
25069|NCT02496221|O3|Outcome|Albiglutide 50 mg and Placebo|Participants were assessed at Follow-up after 28 days following the last dose of albiglutide or placebo.
25070|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25071|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25072|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25073|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25074|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25075|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25076|NCT02496221|O1|Outcome|Albiglutide 50 mg and Placebo|In a total of two treatment periods, participants received Albiglutide 50 mg (A) and Placebo (P) (in a sequence of either A-P or P-A), each administered subcutaneously as a single dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of a cholecystokinin (sincalide) in each period.
25077|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25078|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25079|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25080|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25081|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25390|NCT02492763|O3|Outcome|Placebo|Participants receive matching double-blind placebo QD over 12 weeks.
25083|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25084|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25085|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25086|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25087|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25088|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25089|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25090|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25091|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25092|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25093|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25094|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25095|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25096|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25097|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25098|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25099|NCT02496221|E2|Reported Event|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25100|NCT02496221|E1|Reported Event|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
25101|NCT02496039|B1|Baseline|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
25102|NCT02496039|P1|Participant Flow|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
25103|NCT02496039|O1|Outcome|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
25104|NCT02496039|O1|Outcome|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
25105|NCT02496039|O1|Outcome|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
25106|NCT02496039|O1|Outcome|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
25107|NCT02496039|O1|Outcome|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
36462|NCT02389088|O2|Outcome|Phase I - Week 5 - 0 Hour|
25108|NCT02496039|O1|Outcome|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
25109|NCT02496039|O1|Outcome|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
25110|NCT02496039|O1|Outcome|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
25111|NCT02496039|O1|Outcome|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
25112|NCT02496039|E1|Reported Event|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
25113|NCT02496000|B4|Baseline|Total|Total of all reporting groups
25114|NCT02496000|B3|Baseline|ORMD-0801 Dose 2 = 1.5 * Dose 1|"three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1~ORMD-0801: Oral Insulin"
25115|NCT02496000|B2|Baseline|ORMD-0801 Dose 1|"three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo~ORMD-0801: Oral Insulin"
25116|NCT02496000|B1|Baseline|Placebo Comparator|"three identical capsules containing placebo~Placebo Comparator: Placebo"
25117|NCT02496000|P3|Participant Flow|ORMD-0801 Dose 2 = 1.5 * Dose 1|"three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1~ORMD-0801: Oral Insulin"
25118|NCT02496000|P2|Participant Flow|ORMD-0801 Dose 1|"three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo~ORMD-0801: Oral Insulin"
25119|NCT02496000|P1|Participant Flow|Placebo Comparator|"three identical capsules containing placebo~Placebo Comparator: Placebo"
25120|NCT02496000|O4|Outcome|ORMD-0801 Doses 1 and 2 Combined|The combined measurements of dose 1 and dose 2, in units of mg/dL
25121|NCT02496000|O3|Outcome|ORMD-0801 Dose 2 = 1.5 * Dose 1|"three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1~ORMD-0801: Oral Insulin"
25122|NCT02496000|O2|Outcome|ORMD-0801 Dose 1|"three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo~ORMD-0801: Oral Insulin"
25123|NCT02496000|O1|Outcome|Placebo Comparator|"three identical capsules containing placebo~Placebo Comparator: Placebo"
25124|NCT02496000|E3|Reported Event|ORMD-0801 Dose 2 = 1.5 * Dose 1|"three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1~ORMD-0801: Oral Insulin"
25125|NCT02496000|E2|Reported Event|ORMD-0801 Dose 1|"three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo~ORMD-0801: Oral Insulin"
25126|NCT02496000|E1|Reported Event|Placebo Comparator|"three identical capsules containing placebo~Placebo Comparator: Placebo"
25127|NCT02495948|B1|Baseline|Overall|Lotrafilcon B and samfilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized.
25128|NCT02495948|P2|Participant Flow|ULTRA Then AOA|Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
25129|NCT02495948|P1|Participant Flow|AOA Then ULTRA|Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
25130|NCT02495948|O2|Outcome|ULTRA|Samfilcon A contact lenses worn during Period 1 or Period 2 for 30 days
25131|NCT02495948|O1|Outcome|AIR OPTIX AQUA (AOA)|Lotrafilcon B contact lenses worn during Period 1 or Period 2 for 30 days
25132|NCT02495948|E3|Reported Event|ULTRA|All subjects exposed to samfilcon A contact lenses during Period 1 or Period 2
25133|NCT02495948|E2|Reported Event|AIR OPTIX AQUA|All subjects exposed to lotrafilcon B contact lenses during Period 1 or Period 2
25134|NCT02495948|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
25135|NCT02495831|B1|Baseline|Intervention|"Diclofenac sodium 50 mg oral tablets, single dose~Diclofenac sodium 50 mg oral tablets, single dose and safinamide 200 mg oral tablets, single dose"
25136|NCT02495831|P2|Participant Flow|Safinamide + Diclofenac Sodium First, Diclofenac Sodium Second|Diclofenac sodium 50 mg oral tablets, single dose Safinamide 200 mg oral tablets, single dose
25137|NCT02495831|P1|Participant Flow|Diclofenac Sodium First, Safinamide + Diclofenac Sodium Second|Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose
25138|NCT02495831|O2|Outcome|Diclofenac Sodium and Safinamide|"Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose~Diclofenac sodium and safinamide: Diclofenac 50 mg single dose and safinamide 200 mg single dose"
25139|NCT02495831|O1|Outcome|Diclofenac Sodium|"Diclofenac sodium 50 mg oral tablets, single dose~Diclofenac sodium: Diclofenac sodium 50 mg single dose"
25140|NCT02495831|O2|Outcome|Diclofenac Sodium and Safinamide|"Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose~Diclofenac sodium and safinamide: Diclofenac 50 mg single dose and safinamide 200 mg single dose"
25141|NCT02495831|O1|Outcome|Diclofenac Sodium|"Diclofenac sodium 50 mg oral tablets, single dose~Diclofenac sodium: Diclofenac sodium 50 mg single dose"
25142|NCT02495831|O2|Outcome|Diclofenac Sodium and Safinamide|"Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose~Diclofenac sodium and safinamide: Diclofenac 50 mg single dose and safinamide 200 mg single dose"
25143|NCT02495831|O1|Outcome|Diclofenac Sodium|"Diclofenac sodium 50 mg oral tablets, single dose~Diclofenac sodium: Diclofenac sodium 50 mg single dose"
25144|NCT02495831|O2|Outcome|Diclofenac Sodium and Safinamide|"Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose~Diclofenac sodium and safinamide: Diclofenac 50 mg single dose and safinamide 200 mg single dose"
25146|NCT02495831|O2|Outcome|Diclofenac Sodium and Safinamide|"Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose~Diclofenac sodium and safinamide: Diclofenac 50 mg single dose and safinamide 200 mg single dose"
25147|NCT02495831|O1|Outcome|Diclofenac Sodium|"Diclofenac sodium 50 mg oral tablets, single dose~Diclofenac sodium: Diclofenac sodium 50 mg single dose"
25148|NCT02495831|E2|Reported Event|Diclofenac Sodium and Safinamide|Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose
25149|NCT02495831|E1|Reported Event|Diclofenac Sodium|Diclofenac sodium 50 mg oral tablets, single dose
25150|NCT02495623|B4|Baseline|Total|Total of all reporting groups
25151|NCT02495623|B3|Baseline|Placebo|Placebo
25152|NCT02495623|B2|Baseline|High Dose|42 mg SYN-010
25153|NCT02495623|B1|Baseline|Low Dose|21 mg SYN-010
25154|NCT02495623|P3|Participant Flow|Placebo|Placebo
25155|NCT02495623|P2|Participant Flow|High Dose|42 mg SYN-010
25156|NCT02495623|P1|Participant Flow|Low Dose|21 mg SYN-010
25157|NCT02495623|O3|Outcome|Placebo|"Placebo~Placebo"
25158|NCT02495623|O2|Outcome|High Dose|"42 mg SYN-010~SYN-010 42 mg"
25159|NCT02495623|O1|Outcome|Low Dose|"21 mg SYN-010~SYN-010 21 mg"
25160|NCT02495623|E3|Reported Event|Placebo|"Placebo~Placebo"
25161|NCT02495623|E2|Reported Event|High Dose|"42 mg SYN-010~SYN-010 42 mg"
25162|NCT02495623|E1|Reported Event|Low Dose|"21 mg SYN-010~SYN-010 21 mg"
25163|NCT02495038|B4|Baseline|Total|Total of all reporting groups
25164|NCT02495038|B3|Baseline|20% Reduction of Combination of Esmeron® and Nimbex®, Group L|"This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium~20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95."
25165|NCT02495038|B2|Baseline|10% Reduction of Combination of Esmeron® and Nimbex®, Group S|"This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium~10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe."
25166|NCT02495038|B1|Baseline|Intubating Dose, Group I|"combined ED95 rocuronium and ED95 cisatracurium~ED95, dose causing on average 95% suppression of neuromuscular response."
25167|NCT02495038|P3|Participant Flow|20% Reduction of Combination of Esmeron® and Nimbex®, Group L|"This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium~20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95."
25168|NCT02495038|P2|Participant Flow|10% Reduction of Combination of Esmeron® and Nimbex®, Group S|"This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium~10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe."
25169|NCT02495038|P1|Participant Flow|Intubating Dose, Group I|"combined ED95 rocuronium and ED95 cisatracurium~ED95, dose causing on average 95% suppression of neuromuscular response."
25170|NCT02495038|O3|Outcome|20% Reduction of Combination of Esmeron® and Nimbex®, Group L|"This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium~20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95."
25171|NCT02495038|O2|Outcome|10% Reduction of Combination of Esmeron® and Nimbex®, Group S|"This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium~10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe."
25172|NCT02495038|O1|Outcome|Intubating Dose, Group I|"combined ED95 rocuronium and ED95 cisatracurium~ED95, dose causing on average 95% suppression of neuromuscular response."
25173|NCT02495038|O3|Outcome|20% Reduction of Combination of Esmeron® and Nimbex®, Group L|"This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium~20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95."
25174|NCT02495038|O2|Outcome|10% Reduction of Combination of Esmeron® and Nimbex®, Group S|"This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium~10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe."
25175|NCT02495038|O1|Outcome|Intubating Dose, Group I|"combined ED95 rocuronium and ED95 cisatracurium~ED95, dose causing on average 95% suppression of neuromuscular response."
25251|NCT02494076|O1|Outcome|EzPAP|"Patients randomized to the EzPAP arm will receive first-line therapies and PEP therapy via EzPAP. All patients will receive 4 cycles with 12 breaths per cycle.~EzPAP"
25176|NCT02495038|O3|Outcome|20% Reduction of Combination of Esmeron® and Nimbex®, Group L|"This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium~20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95."
25177|NCT02495038|O2|Outcome|10% Reduction of Combination of Esmeron® and Nimbex®, Group S|"This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium~10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe."
25178|NCT02495038|O1|Outcome|Intubating Dose, Group I|"combined ED95 rocuronium and ED95 cisatracurium~ED95, dose causing on average 95% suppression of neuromuscular response."
25179|NCT02495038|O3|Outcome|20% Reduction of Combination of Esmeron® and Nimbex®, Group L|"This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium~20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95."
25180|NCT02495038|O2|Outcome|10% Reduction of Combination of Esmeron® and Nimbex®, Group S|"This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium~10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe."
25181|NCT02495038|O1|Outcome|Intubating Dose, Group I|"combined ED95 rocuronium and ED95 cisatracurium~ED95, dose causing on average 95% suppression of neuromuscular response."
25182|NCT02495038|O3|Outcome|20% Reduction of Combination of Esmeron® and Nimbex®, Group L|"This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium~20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95."
25183|NCT02495038|O2|Outcome|10% Reduction of Combination of Esmeron® and Nimbex®, Group S|"This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium~10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe."
25184|NCT02495038|O1|Outcome|Intubating Dose, Group I|"combined ED95 rocuronium and ED95 cisatracurium~ED95, dose causing on average 95% suppression of neuromuscular response."
25185|NCT02495038|O3|Outcome|20% Reduction of Combination of Esmeron® and Nimbex®, Group L|"This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium~20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95."
25186|NCT02495038|O2|Outcome|10% Reduction of Combination of Esmeron® and Nimbex®, Group S|"This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium~10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe."
25187|NCT02495038|O1|Outcome|Intubating Dose, Group I|"combined ED95 rocuronium and ED95 cisatracurium~ED95, dose causing on average 95% suppression of neuromuscular response."
25188|NCT02495038|O3|Outcome|20% Reduction of Combination of Esmeron® and Nimbex®, Group L|"This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium~20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95."
25189|NCT02495038|O2|Outcome|10% Reduction of Combination of Esmeron® and Nimbex®, Group S|"This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium~10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe."
25190|NCT02495038|O1|Outcome|Intubating Dose, Group I|"combined ED95 rocuronium and ED95 cisatracurium~ED95, dose causing on average 95% suppression of neuromuscular response."
25191|NCT02495038|O3|Outcome|20% Reduction of Combination of Esmeron® and Nimbex®, Group L|"This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium~20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95."
25207|NCT02494596|O3|Outcome|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
26765|NCT02480582|O2|Outcome|Cheese Savouries|"Sainsbury's savoury biscuits~Cheese Savouries"
25192|NCT02495038|O2|Outcome|10% Reduction of Combination of Esmeron® and Nimbex®, Group S|"This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium~10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe."
25193|NCT02495038|O1|Outcome|Intubating Dose, Group I|"combined ED95 rocuronium and ED95 cisatracurium~ED95, dose causing on average 95% suppression of neuromuscular response."
25194|NCT02495038|O3|Outcome|20% Reduction of Combination of Esmeron® and Nimbex®, Group L|"This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium~20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95."
25195|NCT02495038|O2|Outcome|10% Reduction of Combination of Esmeron® and Nimbex®, Group S|"This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium~10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe."
25196|NCT02495038|O1|Outcome|Intubating Dose, Group I|"combined ED95 rocuronium and ED95 cisatracurium~ED95, dose causing on average 95% suppression of neuromuscular response."
25197|NCT02495038|O3|Outcome|20% Reduction of Combination of Esmeron® and Nimbex®, Group L|"This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium~20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95."
25198|NCT02495038|O2|Outcome|10% Reduction of Combination of Esmeron® and Nimbex®, Group S|"This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium~10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe."
25199|NCT02495038|O1|Outcome|Intubating Dose, Group I|"combined ED95 rocuronium and ED95 cisatracurium~ED95, dose causing on average 95% suppression of neuromuscular response."
25200|NCT02495038|E3|Reported Event|20% Reduction of Combination of Esmeron® and Nimbex®, Group L|"This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium~20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95.~Group L included 1 patient with Grade 1 (Good) intubation and 2 patients with Grade 2 (Poor) intubation. The patients with Grade 2 intubation coughed during intubation and 1 of these patients produced small arm movements during coughing."
25201|NCT02495038|E2|Reported Event|10% Reduction of Combination of Esmeron® and Nimbex®, Group S|"This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium~10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe.~The duration of intubation did not differ between groups. Group I and S were intubation Grade 0 (Excellent) intubation"
25202|NCT02495038|E1|Reported Event|Intubating Dose, Group I|"combined ED95 rocuronium and ED95 cisatracurium~ED95, dose causing on average 95% suppression of neuromuscular response.~The duration of intubation did not differ between groups. Group I and S were intubation Grade 0 (Excellent) intubation."
25203|NCT02494596|B1|Baseline|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825, 1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
25204|NCT02494596|P3|Participant Flow|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
25205|NCT02494596|P2|Participant Flow|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
25206|NCT02494596|P1|Participant Flow|Capecitabine 825 Plus (+) Pertuzumab 1050|Participants received a single dose of capecitabine 825 milligrams per square meter (mg/m^2) orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
25249|NCT02494076|O1|Outcome|EzPAP|"Patients randomized to the EzPAP arm will receive first-line therapies and PEP therapy via EzPAP. All patients will receive 4 cycles with 12 breaths per cycle.~EzPAP"
25208|NCT02494596|O2|Outcome|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
25209|NCT02494596|O1|Outcome|Capecitabine 825 + Pertuzumab 1050|Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
25210|NCT02494596|O3|Outcome|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
25211|NCT02494596|O2|Outcome|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
25212|NCT02494596|O1|Outcome|Capecitabine 825 + Pertuzumab 1050|Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
25213|NCT02494596|O3|Outcome|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
25214|NCT02494596|O2|Outcome|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
25215|NCT02494596|O1|Outcome|Capecitabine 825 + Pertuzumab 1050|Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
25216|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
25217|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
25218|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
25219|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
25220|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825, 1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
25221|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
25222|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825, 1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
25223|NCT02494596|O3|Outcome|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
25224|NCT02494596|O2|Outcome|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
25391|NCT02492763|O2|Outcome|MK-8521 300 μg|Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
25225|NCT02494596|O1|Outcome|Capecitabine 825 Plus (+) Pertuzumab 1050|Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
25226|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
25227|NCT02494596|E3|Reported Event|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
25228|NCT02494596|E2|Reported Event|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
25229|NCT02494596|E1|Reported Event|Capecitabine 825 + Pertuzumab 1050|Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
25230|NCT02494440|B1|Baseline|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.~The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
25231|NCT02494440|P1|Participant Flow|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.~The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
25232|NCT02494440|O1|Outcome|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.~The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
25233|NCT02494440|O1|Outcome|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.~The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
25234|NCT02494440|O1|Outcome|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.~The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
25235|NCT02494440|E1|Reported Event|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.~The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
25236|NCT02494323|B1|Baseline|Functional Electrical Stimulation|"Dual channel stimulation of the peroneal nerve to improve dropfoot~Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot"
25237|NCT02494323|P1|Participant Flow|Functional Electrical Stimulation|"Dual channel stimulation of the peroneal nerve to improve dropfoot~Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot"
25238|NCT02494323|O1|Outcome|Functional Electrical Stimulation|"Dual channel stimulation of the peroneal nerve to improve dropfoot~Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot"
25239|NCT02494323|O1|Outcome|Functional Electrical Stimulation|"Dual channel stimulation of the peroneal nerve to improve dropfoot~Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot"
25240|NCT02494323|E1|Reported Event|Functional Electrical Stimulation|"Dual channel stimulation of the peroneal nerve to improve dropfoot~Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot"
25241|NCT02494076|B3|Baseline|Total|Total of all reporting groups
25242|NCT02494076|B2|Baseline|Standard Care|"Patients randomized to the control arm will receive first-line therapies and standard therapy.~Standard Care"
25243|NCT02494076|B1|Baseline|EzPAP|"Patients randomized to the EzPAP arm will receive first-line therapies and PEP therapy via EzPAP. All patients will receive 4 cycles with 12 breaths per cycle.~EzPAP"
25244|NCT02494076|P2|Participant Flow|Standard Care|"Patients randomized to the control arm will receive first-line therapies and standard therapy.~Standard Care"
25245|NCT02494076|P1|Participant Flow|EzPAP|"Patients randomized to the EzPAP arm will receive first-line therapies and PEP therapy via EzPAP. All patients will receive 4 cycles with 12 breaths per cycle.~EzPAP"
25246|NCT02494076|O2|Outcome|Standard Care|"Patients randomized to the control arm will receive first-line therapies and standard therapy.~Standard Care"
25247|NCT02494076|O1|Outcome|EzPAP|"Patients randomized to the EzPAP arm will receive first-line therapies and PEP therapy via EzPAP. All patients will receive 4 cycles with 12 breaths per cycle.~EzPAP"
25248|NCT02494076|O2|Outcome|Standard Care|"Patients randomized to the control arm will receive first-line therapies and standard therapy.~Standard Care"
25392|NCT02492763|O1|Outcome|MK-8521 180 μg|Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
25253|NCT02494076|E1|Reported Event|EzPAP|"Patients randomized to the EzPAP arm will receive first-line therapies and PEP therapy via EzPAP. All patients will receive 4 cycles with 12 breaths per cycle.~EzPAP"
25254|NCT02493855|B4|Baseline|Total|Total of all reporting groups
25255|NCT02493855|B3|Baseline|Arm C: Ribavirin Low-dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
25256|NCT02493855|B2|Baseline|Arm B: Ribavirin Full Dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.
25257|NCT02493855|B1|Baseline|Arm A: Ribavirin Full Dose for Last 10 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.
25258|NCT02493855|P3|Participant Flow|Arm C: Ribavirin Low-dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
25259|NCT02493855|P2|Participant Flow|Arm B: Ribavirin Full Dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.
25260|NCT02493855|P1|Participant Flow|Arm A: Ribavirin Full Dose for Last 10 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.
25261|NCT02493855|O3|Outcome|Arm C: Ribavirin Low-dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
25262|NCT02493855|O2|Outcome|Arm B: Ribavirin Full Dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.
25263|NCT02493855|O1|Outcome|Arm A: Ribavirin Full Dose for Last 10 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.
25264|NCT02493855|E3|Reported Event|Arm C: Ribavirin Low-dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
25265|NCT02493855|E2|Reported Event|Arm B: Ribavirin Full Dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.
25266|NCT02493855|E1|Reported Event|Arm A: Ribavirin Full Dose for Last 10 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.
25267|NCT02493127|B3|Baseline|Total|Total of all reporting groups
25268|NCT02493127|B2|Baseline|Positive PCS|"Grip strength measurements and completes positively adjusted PCS~Grip Strength: Research Assistant takes Grip Strength Measurements~Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire"
25269|NCT02493127|B1|Baseline|Standard PCS|"Grip strength measurements and completes standard PCS~Standard PCS: Subject completes the standard version of the PCS Questionnaire~Grip Strength: Research Assistant takes Grip Strength Measurements"
25270|NCT02493127|P2|Participant Flow|Positive PCS|"Grip strength measurements and completes positively adjusted PCS~Grip Strength: Research Assistant takes Grip Strength Measurements~Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire"
25271|NCT02493127|P1|Participant Flow|Standard PCS|"Grip strength measurements and completes standard PCS~Standard PCS: Subject completes the standard version of the PCS Questionnaire~Grip Strength: Research Assistant takes Grip Strength Measurements"
25272|NCT02493127|O2|Outcome|Positive PCS|"Grip strength measurements and completes positively adjusted PCS~Grip Strength: Research Assistant takes Grip Strength Measurements~Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire"
25273|NCT02493127|O1|Outcome|Standard PCS|"Grip strength measurements and completes standard PCS~Standard PCS: Subject completes the standard version of the PCS Questionnaire~Grip Strength: Research Assistant takes Grip Strength Measurements"
25274|NCT02493127|O2|Outcome|Positive PCS|"Grip strength measurements and completes positively adjusted PCS~Grip Strength: Research Assistant takes Grip Strength Measurements~Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire"
25275|NCT02493127|O1|Outcome|Standard PCS|"Grip strength measurements and completes standard PCS~Standard PCS: Subject completes the standard version of the PCS Questionnaire~Grip Strength: Research Assistant takes Grip Strength Measurements"
25276|NCT02493127|O2|Outcome|Positive PCS|"Grip strength measurements and completes positively adjusted PCS~Grip Strength: Research Assistant takes Grip Strength Measurements~Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire"
25277|NCT02493127|O1|Outcome|Standard PCS|"Grip strength measurements and completes standard PCS~Standard PCS: Subject completes the standard version of the PCS Questionnaire~Grip Strength: Research Assistant takes Grip Strength Measurements"
25278|NCT02493127|O1|Outcome|Positive PCS|"Grip strength measurements and completes positively adjusted PCS~Grip Strength: Research Assistant takes Grip Strength Measurements~Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire"
25279|NCT02493127|O1|Outcome|Standard Pain Catastrophizing Scale (PCS)|"Grip strength measurements and completes standard PCS~Standard PCS: Subject completes the standard version of the PCS Questionnaire~Grip Strength: Research Assistant takes Grip Strength Measurements"
25280|NCT02493127|E2|Reported Event|Positive PCS|"Grip strength measurements and completes positively adjusted PCS~Grip Strength: Research Assistant takes Grip Strength Measurements~Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire"
25393|NCT02492763|O4|Outcome|Liraglutide 1.8 mg|Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
25281|NCT02493127|E1|Reported Event|Standard PCS|"Grip strength measurements and completes standard PCS~Standard PCS: Subject completes the standard version of the PCS Questionnaire~Grip Strength: Research Assistant takes Grip Strength Measurements"
25282|NCT02493088|B1|Baseline|Antisocial Personality|"Individuals Diagnosed with Antisocial Personality Disorder~Antisocial personality recording of behavior and contextual elements: aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder will be recorded during the study"
25283|NCT02493088|P1|Participant Flow|Antisocial Personality|"Individuals Diagnosed with Antisocial Personality Disorder~Antisocial personality recording of behavior and contextual elements: aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder will be recorded during the study"
25284|NCT02493088|O1|Outcome|Antisocial Personality|"Individuals Diagnosed with Antisocial Personality Disorder~Antisocial personality recording of behavior and contextual elements: aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder will be recorded during the study"
25285|NCT02493088|O1|Outcome|Antisocial Personality|"Individuals Diagnosed with Antisocial Personality Disorder~Antisocial personality recording of behavior and contextual elements: aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder will be recorded during the study"
25286|NCT02493088|O1|Outcome|Antisocial Personality|"Individuals Diagnosed with Antisocial Personality Disorder~Antisocial personality recording of behavior and contextual elements: aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder will be recorded during the study"
25287|NCT02493088|E1|Reported Event|Antisocial Personality|"Individuals Diagnosed with Antisocial Personality Disorder~Aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder were recorded during the study.~Adverse events were not related to the study.~Recorded adverse events were situations where subjects were harmed and required medical intervention."
25288|NCT02493036|B4|Baseline|Total|Total of all reporting groups
25289|NCT02493036|B3|Baseline|Placebo/42-mg SYN-010|Placebo in study NCT02495623 followed by 42-mg SYN-010 in current study
25290|NCT02493036|B2|Baseline|21-mg SYN-010/42-mg SYN-010|21-mg SYN-010 in study NCT02495623 followed by 42-mg SYN-010 in current study
25291|NCT02493036|B1|Baseline|42-mg SYN-010/42-mg SYN-010|42-mg SYN-010 in study NCT02495623 followed by 42-mg SYN-010 in current study
25292|NCT02493036|P3|Participant Flow|Placebo|Placebo
25293|NCT02493036|P2|Participant Flow|Low Dose SYN-010|21-mg SYN-010
25294|NCT02493036|P1|Participant Flow|High Dose SYN-010|42-mg SYN-010
25295|NCT02493036|O3|Outcome|Placebo/42-mg SYN-010|Subjects were on placebo in the 4-week (double-blind) study and then received 42 mg in the 8-week extension study
25296|NCT02493036|O2|Outcome|21-mg SYN-010/42-mg SYN-010|Subjects were on 21 mg in the 4-week (double-blind) study and then received 42 mg in the 8-week extension study
25297|NCT02493036|O1|Outcome|42-mg SYN-010/42-mg SYN-010|Subjects were on 42 mg in the 4-week (double-blind) study and were continued on 42 mg in the 8-week extension study
25298|NCT02493036|E3|Reported Event|Placebo/42-mg SYN-010|Subjects were on placebo in the 4-week (double-blind) study and then received 42 mg in the 8-week extension study
25299|NCT02493036|E2|Reported Event|21-mg SYN-010/42-mg SYN-010|Subjects were on 21 mg in the 4-week (double-blind) study and then received 42 mg in the 8-week extension study
25300|NCT02493036|E1|Reported Event|42-mg SYN-010/42-mg SYN-010|Subjects were on 42 mg in the 4-week (double-blind) study and were continued on 42 mg in the 8-week extension study
25301|NCT02492984|B3|Baseline|Total|Total of all reporting groups
25302|NCT02492984|B2|Baseline|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
25303|NCT02492984|B1|Baseline|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
25304|NCT02492984|P2|Participant Flow|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
25305|NCT02492984|P1|Participant Flow|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
25306|NCT02492984|O2|Outcome|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
25307|NCT02492984|O1|Outcome|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
25308|NCT02492984|O1|Outcome|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
25309|NCT02492984|O2|Outcome|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
25310|NCT02492984|O1|Outcome|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
25311|NCT02492984|O1|Outcome|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
25312|NCT02492984|O1|Outcome|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
25313|NCT02492984|O1|Outcome|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
25314|NCT02492984|O1|Outcome|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
25315|NCT02492984|O1|Outcome|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
25316|NCT02492984|O1|Outcome|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
25317|NCT02492984|O2|Outcome|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
25318|NCT02492984|O1|Outcome|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
25319|NCT02492984|O2|Outcome|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
25320|NCT02492984|O1|Outcome|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
25321|NCT02492984|E3|Reported Event|Total|Treatment Group Description TBD
25322|NCT02492984|E2|Reported Event|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
25323|NCT02492984|E1|Reported Event|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
25324|NCT02492841|B4|Baseline|Total|Total of all reporting groups
25325|NCT02492841|B3|Baseline|Biodentine|"Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping~Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution."
25326|NCT02492841|B2|Baseline|Calcium Hydroxide|"-material for pulp capping~Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material."
25327|NCT02492841|B1|Baseline|Mineral Trioxide Aggregate (MTA)|"Mineral trioxide aggregate Root canal repair material~Mineral trioxide aggregate: Mineral trioxide aggregate"
25328|NCT02492841|P3|Participant Flow|Biodentine|"Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping~Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution."
25329|NCT02492841|P2|Participant Flow|Calcium Hydroxide|"-material for pulp capping~Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material."
25330|NCT02492841|P1|Participant Flow|Mineral Trioxide Aggregate (MTA)|"Mineral trioxide aggregate Root canal repair material~Mineral trioxide aggregate: Mineral trioxide aggregate"
25331|NCT02492841|O3|Outcome|Biodentine|"Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping~Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution."
25332|NCT02492841|O2|Outcome|Calcium Hydroxide|"-material for pulp capping~Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material."
25333|NCT02492841|O1|Outcome|Mineral Trioxide Aggregate (MTA)|"Mineral trioxide aggregate Root canal repair material~Mineral trioxide aggregate: Mineral trioxide aggregate"
25334|NCT02492841|O3|Outcome|Biodentine|"Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping~Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution.~Cero failed up to 12 months follow up"
25335|NCT02492841|O2|Outcome|Calcium Hydroxide|"-material for pulp capping~Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material.~Three failed up to 12 months follow up~two endodontic~one tooth extraction"
25336|NCT02492841|O1|Outcome|Mineral Trioxide Aggregate (MTA)|"Mineral trioxide aggregate Root canal repair material~Mineral trioxide aggregate: Mineral trioxide aggregate~Three failed up to 12 months follow up.~one endodontic~one pulpotomy~one pulp capping"
25337|NCT02492841|E3|Reported Event|Biodentine|"Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping~Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution."
25394|NCT02492763|O3|Outcome|Placebo|Participants receive matching double-blind placebo QD over 12 weeks.
25338|NCT02492841|E2|Reported Event|Calcium Hydroxide|"-material for pulp capping~Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material."
25339|NCT02492841|E1|Reported Event|Mineral Trioxide Aggregate (MTA)|"Mineral trioxide aggregate Root canal repair material~Mineral trioxide aggregate: Mineral trioxide aggregate"
25340|NCT02492763|B5|Baseline|Total|Total of all reporting groups
25341|NCT02492763|B4|Baseline|Liraglutide 1.8 mg|Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
25342|NCT02492763|B3|Baseline|Placebo|Participants receive matching double-blind placebo QD over 12 weeks.
25343|NCT02492763|B2|Baseline|MK-8521 300 μg|Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
25344|NCT02492763|B1|Baseline|MK-8521 180 μg|Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
25345|NCT02492763|P4|Participant Flow|Liraglutide 1.8 mg|Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
25346|NCT02492763|P3|Participant Flow|Placebo|Participants receive matching double-blind placebo QD over 12 weeks.
25347|NCT02492763|P2|Participant Flow|MK-8521 300 μg|Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
25348|NCT02492763|P1|Participant Flow|MK-8521 180 μg|Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
25349|NCT02492763|O4|Outcome|Liraglutide 1.8 mg|Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
25350|NCT02492763|O3|Outcome|Placebo|Participants receive matching double-blind placebo QD over 12 weeks.
25351|NCT02492763|O2|Outcome|MK-8521 300 μg|Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
25352|NCT02492763|O1|Outcome|MK-8521 180 μg|Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
25353|NCT02492763|O4|Outcome|Liraglutide 1.8 mg|Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
25354|NCT02492763|O3|Outcome|Placebo|Participants receive matching double-blind placebo QD over 12 weeks.
25355|NCT02492763|O2|Outcome|MK-8521 300 μg|Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
25356|NCT02492763|O1|Outcome|MK-8521 180 μg|Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
25357|NCT02492763|O4|Outcome|Liraglutide 1.8 mg|Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
25358|NCT02492763|O3|Outcome|Placebo|Participants receive matching double-blind placebo QD over 12 weeks.
25359|NCT02492763|O2|Outcome|MK-8521 300 μg|Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
25360|NCT02492763|O1|Outcome|MK-8521 180 μg|Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
25361|NCT02492763|O4|Outcome|Liraglutide 1.8 mg|Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
25362|NCT02492763|O3|Outcome|Placebo|Participants receive matching double-blind placebo QD over 12 weeks.
25363|NCT02492763|O2|Outcome|MK-8521 300 μg|Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
25364|NCT02492763|O1|Outcome|MK-8521 180 μg|Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
25365|NCT02492763|O4|Outcome|Liraglutide 1.8 mg|Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
25366|NCT02492763|O3|Outcome|Placebo|Participants receive matching double-blind placebo QD over 12 weeks.
25367|NCT02492763|O2|Outcome|MK-8521 300 μg|Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
25368|NCT02492763|O1|Outcome|MK-8521 180 μg|Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
25369|NCT02492763|O4|Outcome|Liraglutide 1.8 mg|Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
25370|NCT02492763|O3|Outcome|Placebo|Participants receive matching double-blind placebo QD over 12 weeks.
25371|NCT02492763|O2|Outcome|MK-8521 300 μg|Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
25372|NCT02492763|O1|Outcome|MK-8521 180 μg|Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
25373|NCT02492763|O4|Outcome|Liraglutide 1.8 mg|Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
25374|NCT02492763|O3|Outcome|Placebo|Participants receive matching double-blind placebo QD over 12 weeks.
25375|NCT02492763|O2|Outcome|MK-8521 300 μg|Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
25376|NCT02492763|O1|Outcome|MK-8521 180 μg|Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
25377|NCT02492763|O4|Outcome|Liraglutide 1.8 mg|Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
25378|NCT02492763|O3|Outcome|Placebo|Participants receive matching double-blind placebo QD over 12 weeks.
25379|NCT02492763|O2|Outcome|MK-8521 300 μg|Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
25380|NCT02492763|O1|Outcome|MK-8521 180 μg|Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
25381|NCT02492763|O4|Outcome|Liraglutide 1.8 mg|Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
25382|NCT02492763|O3|Outcome|Placebo|Participants receive matching double-blind placebo QD over 12 weeks.
25383|NCT02492763|O2|Outcome|MK-8521 300 μg|Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
25384|NCT02492763|O1|Outcome|MK-8521 180 μg|Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
25385|NCT02492763|O4|Outcome|Liraglutide 1.8 mg|Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
25386|NCT02492763|O3|Outcome|Placebo|Participants receive matching double-blind placebo QD over 12 weeks.
25387|NCT02492763|O2|Outcome|MK-8521 300 μg|Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
25388|NCT02492763|O1|Outcome|MK-8521 180 μg|Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
25397|NCT02492763|E4|Reported Event|Liraglutide 1.8 mg|Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
25398|NCT02492763|E3|Reported Event|Placebo|Participants receive matching double-blind placebo QD over 12 weeks.
25399|NCT02492763|E2|Reported Event|MK-8521 300 μg|Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
25400|NCT02492763|E1|Reported Event|MK-8521 180 μg|Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
25401|NCT02492451|B4|Baseline|Total|Total of all reporting groups
25402|NCT02492451|B3|Baseline|Control Group|Only intrauterine insemination
25403|NCT02492451|B2|Baseline|Luteal Phase Support|"Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.~progesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy."
25404|NCT02492451|B1|Baseline|Endometrial Injury|"Endometrial injury in luteal phase of preceding IUI cycle~Endometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula"
25405|NCT02492451|P3|Participant Flow|Control Group|Only intrauterine insemination
25406|NCT02492451|P2|Participant Flow|Luteal Phase Support|"Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.~progesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy."
25407|NCT02492451|P1|Participant Flow|Endometrial Injury|"Endometrial injury in luteal phase of preceding IUI cycle~Endometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula"
25408|NCT02492451|O3|Outcome|Control Group|Only intrauterine insemination
25409|NCT02492451|O2|Outcome|Luteal Phase Support|"Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.~progesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy."
25410|NCT02492451|O1|Outcome|Endometrial Injury|"Endometrial injury in luteal phase of preceding IUI cycle~Endometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula"
25411|NCT02492451|E3|Reported Event|Control Group|Only intrauterine insemination
25412|NCT02492451|E2|Reported Event|Luteal Phase Support|"Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.~progesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy."
25413|NCT02492451|E1|Reported Event|Endometrial Injury|"Endometrial injury in luteal phase of preceding IUI cycle~Endometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula"
25414|NCT02492165|B5|Baseline|Total|Total of all reporting groups
25415|NCT02492165|B4|Baseline|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25416|NCT02492165|B3|Baseline|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25417|NCT02492165|B2|Baseline|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25418|NCT02492165|B1|Baseline|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25419|NCT02492165|P4|Participant Flow|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25420|NCT02492165|P3|Participant Flow|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25421|NCT02492165|P2|Participant Flow|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25422|NCT02492165|P1|Participant Flow|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25423|NCT02492165|O4|Outcome|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25424|NCT02492165|O3|Outcome|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25425|NCT02492165|O2|Outcome|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25426|NCT02492165|O1|Outcome|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25427|NCT02492165|O4|Outcome|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
26766|NCT02480582|O1|Outcome|Almonds|"Whole, raw almonds~Almonds"
25428|NCT02492165|O3|Outcome|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25429|NCT02492165|O2|Outcome|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25430|NCT02492165|O1|Outcome|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25431|NCT02492165|O4|Outcome|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25432|NCT02492165|O3|Outcome|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25433|NCT02492165|O2|Outcome|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25434|NCT02492165|O1|Outcome|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25435|NCT02492165|O4|Outcome|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25436|NCT02492165|O3|Outcome|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25437|NCT02492165|O2|Outcome|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25438|NCT02492165|O1|Outcome|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25439|NCT02492165|E4|Reported Event|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25440|NCT02492165|E3|Reported Event|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25441|NCT02492165|E2|Reported Event|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25442|NCT02492165|E1|Reported Event|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
25443|NCT02491944|B1|Baseline|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
25444|NCT02491944|P1|Participant Flow|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
25445|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
25446|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
25447|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
25448|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
25449|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
25450|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
25451|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
25452|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
25453|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
25454|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
25455|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
25456|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
25457|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
25458|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
25459|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
25460|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
25461|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
25462|NCT02491944|E1|Reported Event|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
25463|NCT02491892|B3|Baseline|Total|Total of all reporting groups
25464|NCT02491892|B2|Baseline|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
25465|NCT02491892|B1|Baseline|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
25466|NCT02491892|P2|Participant Flow|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
25467|NCT02491892|P1|Participant Flow|Pertuzumab 420 mg|Participants received a loading dose of 840 milligrams (mg) via intravenous (IV) infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
25468|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
25469|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
25470|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
25471|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
25472|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
25473|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
25474|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
25475|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
25476|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
25477|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
25478|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
25479|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
25480|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
25481|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
25482|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
25483|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
25484|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
25485|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
25486|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
25487|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
25488|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
25489|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
25490|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
25491|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
25492|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
25493|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
25494|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
25495|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
25496|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
25497|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
25498|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
25499|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
25500|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
25501|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
25502|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
25503|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
25504|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
25505|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
25506|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
25507|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
25508|NCT02491892|E2|Reported Event|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
25509|NCT02491892|E1|Reported Event|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
25510|NCT02491073|B3|Baseline|Total|Total of all reporting groups
25511|NCT02491073|B2|Baseline|Non-Eslicarbazepine Acetate Treated|blood draw: Investigate the possibility of assay artifacts impacting the measurement of thyroid hormones, in particular FT4 and FT3, in ESL treated subjects compared to non-ESL-treated subjects.
25512|NCT02491073|B1|Baseline|Eslicarbazepine Acetate Treated|blood draw: Investigate the possibility of assay artifacts impacting the measurement of thyroid hormones, in particular FT4 and FT3, in ESL treated subjects compared to non-ESL-treated subjects.
25513|NCT02491073|P2|Participant Flow|Healthy Volunteers|Adult male and female healthy volunteer (greater than or equal to 18 years) not exposed to ESL at the time of blood draw
25514|NCT02491073|P1|Participant Flow|Eslicarbazepine Acetate Exposed Subjects|Adult male and female subjects (greater than or equal to 18 years)who had received at least 1200 mg QD eslicarbazapine acetate (ESL) for at least 6 weeks and had not experienced any rash or other allergic reaction at the time of the blood draw
25515|NCT02491073|O4|Outcome|High-spiked Serum(HS)Healthy Volunteers|thyroid hormone level in the serum sample of healthy volunteers which was spiked with high level of ESL metabolites
25516|NCT02491073|O3|Outcome|Mid-spiked Serum(MS)Healthy Volunteers|thyroid hormone level in the serum sample of healthy volunteers which was spiked with medium level of ESL metabolites
25517|NCT02491073|O2|Outcome|Low-spiked Serum(LS)Healthy Volunteers|thyroid hormone level in the serum sample of healthy volunteers which was spiked with low level of ESL metabolites
25518|NCT02491073|O1|Outcome|Non-spiked Serum(NS) Healthy Volunteers|thyroid hormone level in the serum sample of healthy volunteers which was not spiked with ESL metabolites
25770|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25519|NCT02491073|O8|Outcome|Optimized Equilibrium Dialysis Method(ED)(HS)Healthyvolunteer|Free thyroid hormone level as measured by the optimized equilibrium dialysis method in the serum sample of healthy volunteers which was spiked with high level of ESL metabolites
25520|NCT02491073|O7|Outcome|Automated Kit Assay(AK)High-spikedSerum(HS)Healthy Volunteers|Free thyroid hormone level as measured by the automated kit assay in the serum sample of healthy volunteers which was spiked with high level of ESL metabolites
25521|NCT02491073|O6|Outcome|Optimized Equilibrium Dialysis Method(ED)(MS)Healthyvolunteer|Free thyroid hormone level as measured by the optimized equilibrium dialysis method in the serum sample of healthy volunteers which was spiked with medium level of ESL metabolites
25522|NCT02491073|O5|Outcome|Automated Kit Assay(AK)Med-spikedSerum(MS)Healthy Volunteers|Free thyroid hormone level as measured by the automated kit assay in the serum sample of healthy volunteers which was spiked with medium level of ESL metabolites
25523|NCT02491073|O4|Outcome|Optimized Equilibrium Dialysis Method(ED)(LS)Healthyvolunteer|Free thyroid hormone level as measured by the optimized equilibrium dialysis method in the serum sample of healthy volunteers which was spiked with low level of ESL metabolites
25524|NCT02491073|O3|Outcome|Automated Kit Assay(AK)Low-spiked Serum(LS)Healthy Volunteers|Free thyroid hormone level as measured by the automated kit assay in the serum sample of healthy volunteers which was spiked with low level of ESL metabolites
25525|NCT02491073|O2|Outcome|Optimized Equilibrium Dialysis Method(ED)(NS)Healthyvolunteer|Free thyroid hormone level as measured by the optimized equilibrium dialysis method in the serum sample of healthy volunteers which was not spiked with ESL metabolites
25526|NCT02491073|O1|Outcome|Automated Kit Assay(AK)Non-spiked Serum(NS)Healthy Volunteers|Free thyroid hormone level as measured by the automated kit assay in the serum sample of healthy volunteers which was not spiked with ESL metabolites
25527|NCT02491073|O4|Outcome|High-spiked Serum(HS)Healthy Volunteers|thyroid hormone level in the serum sample of healthy volunteers which was spiked with high level of ESL metabolites
25528|NCT02491073|O3|Outcome|Mid-spiked Serum(MS)Healthy Volunteers|thyroid hormone level in the serum sample of healthy volunteers which was spiked with medium level of ESL metabolites
25529|NCT02491073|O2|Outcome|Low-spiked Serum(LS)Healthy Volunteers|thyroid hormone level in the serum sample of healthy volunteers which was spiked with low level of ESL metabolites
25530|NCT02491073|O1|Outcome|Non-spiked Serum(NS) Healthy Volunteers|thyroid hormone level in the serum sample of healthy volunteers which was not spiked with ESL metabolites
25531|NCT02491073|O4|Outcome|High-spiked Serum(HS)Healthy Volunteers|Free thyroid hormone level in the serum sample of healthy volunteers which was spiked with high level of ESL metabolites
25532|NCT02491073|O3|Outcome|Mid-spiked Serum(MS)Healthy Volunteers|Free thyroid hormone level in the serum sample of healthy volunteers which was spiked with medium level of ESL metabolites
25533|NCT02491073|O2|Outcome|Low-spiked Serum(LS)Healthy Volunteers|Free thyroid hormone level in the serum sample of healthy volunteers which was spiked with low level of ESL metabolites
25534|NCT02491073|O1|Outcome|Non-spiked Serum(NS) Healthy Volunteers|Free thyroid hormone level in the serum sample of healthy volunteers which was not spiked with ESL metabolites
25535|NCT02491073|O2|Outcome|Optimized Equilibrium Dialysis Method (ED)ESL-exposed Subjects|Free thyroid hormone level in the serum sample of ESL-exposed subjects as measured by the optimized equilibrium dialysis method
25536|NCT02491073|O1|Outcome|Automated Kit Assay (AK) – ESL-exposed Subjects|Free thyroid hormone level in the serum sample of ESL-exposed subjects as measured by the automated kit assay
25537|NCT02491073|E2|Reported Event|Healthy Volunteers|Adult male and female healthy volunteer (greater than or equal to 18 years) not exposed to ESL at the time of blood draw
25538|NCT02491073|E1|Reported Event|Eslicarbazepine Acetate Exposed Subjects|Adult male and female subjects (greater than or equal to 18 years)who had received at least 1200 mg QD eslicarbazapine acetate (ESL) for at least 6 weeks and had not experienced any rash or other allergic reaction at the time of the blood draw
25539|NCT02490670|B3|Baseline|Total|Total of all reporting groups
25540|NCT02490670|B2|Baseline|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test – 1 occasion) and Cephalexin A formulation (Treatment A, Reference – 1 occasion).
25541|NCT02490670|B1|Baseline|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).
25542|NCT02490670|P2|Participant Flow|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test – 1 occasion) and Cephalexin A formulation (Treatment A, Reference – 1 occasion).
25543|NCT02490670|P1|Participant Flow|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).
25544|NCT02490670|O2|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods.
25545|NCT02490670|O1|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
25546|NCT02490670|O2|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods.
25547|NCT02490670|O1|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
25548|NCT02490670|E2|Reported Event|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods.
25549|NCT02490670|E1|Reported Event|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
25550|NCT02490475|B5|Baseline|Total|Total of all reporting groups
25618|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
25619|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
25551|NCT02490475|B4|Baseline|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25552|NCT02490475|B3|Baseline|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25553|NCT02490475|B2|Baseline|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25554|NCT02490475|B1|Baseline|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25555|NCT02490475|P4|Participant Flow|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25556|NCT02490475|P3|Participant Flow|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25557|NCT02490475|P2|Participant Flow|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25558|NCT02490475|P1|Participant Flow|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 milligrams per square meter (mg/m^2) docetaxel and 1050 mg of pertuzumab as an intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 hours (h) apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25559|NCT02490475|O4|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25560|NCT02490475|O3|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25561|NCT02490475|O2|Outcome|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25562|NCT02490475|O1|Outcome|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25620|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
25625|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
25563|NCT02490475|O6|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25564|NCT02490475|O5|Outcome|Docetaxel 100 Alone|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25565|NCT02490475|O4|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25566|NCT02490475|O3|Outcome|Docetaxel 75 Alone|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25567|NCT02490475|O2|Outcome|Docetaxel 60 + Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25568|NCT02490475|O1|Outcome|Docetaxel 60 Alone|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25569|NCT02490475|O6|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25570|NCT02490475|O5|Outcome|Docetaxel 100 Alone|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25571|NCT02490475|O4|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25572|NCT02490475|O3|Outcome|Docetaxel 75 Alone|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25573|NCT02490475|O2|Outcome|Docetaxel 60 + Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25574|NCT02490475|O1|Outcome|Docetaxel 60 Alone|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25621|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
25771|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
26767|NCT02480582|O3|Outcome|No Food|No food provided, just water
25575|NCT02490475|O6|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25576|NCT02490475|O5|Outcome|Docetaxel 100 Alone|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25577|NCT02490475|O4|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25578|NCT02490475|O3|Outcome|Docetaxel 75 Alone|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25579|NCT02490475|O2|Outcome|Docetaxel 60 + Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25580|NCT02490475|O1|Outcome|Docetaxel 60 Alone|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25581|NCT02490475|O6|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25582|NCT02490475|O5|Outcome|Docetaxel 100 Alone|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25583|NCT02490475|O4|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25584|NCT02490475|O3|Outcome|Docetaxel 75 Alone|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25585|NCT02490475|O2|Outcome|Docetaxel 60 + Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25586|NCT02490475|O1|Outcome|Docetaxel 60 Alone|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25622|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
25623|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
25587|NCT02490475|O6|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25588|NCT02490475|O5|Outcome|Docetaxel 100 Alone|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25589|NCT02490475|O4|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25590|NCT02490475|O3|Outcome|Docetaxel 75 Alone|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25591|NCT02490475|O2|Outcome|Docetaxel 60 + Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25592|NCT02490475|O1|Outcome|Docetaxel 60 Alone|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25593|NCT02490475|O6|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25594|NCT02490475|O5|Outcome|Docetaxel 100 Alone|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25595|NCT02490475|O4|Outcome|Docetaxel 75+ Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25596|NCT02490475|O3|Outcome|Docetaxel 75 Alone|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25597|NCT02490475|O2|Outcome|Docetaxel 60 + Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25598|NCT02490475|O1|Outcome|Docetaxel 60 Alone|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25624|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
25772|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25599|NCT02490475|O4|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25600|NCT02490475|O3|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25601|NCT02490475|O2|Outcome|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25602|NCT02490475|O1|Outcome|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25603|NCT02490475|O4|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25604|NCT02490475|O3|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25605|NCT02490475|O2|Outcome|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25606|NCT02490475|O1|Outcome|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25607|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
25608|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
25609|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
25610|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
25611|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
25612|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
25613|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
25614|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
25615|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
25616|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
25617|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
25626|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
25627|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
25628|NCT02490475|O1|Outcome|Entire Study Population|Participants received escalating dose levels of combination of docetaxel and pertuzumab. Participants received docetaxel 60 mg/m^2 and pertuzumab 1050 mg at dose level 1, docetaxel 75 mg/m^2 and pertuzumab 1050 mg at dose level 2, docetaxel 75 mg/m^2 and pertuzumab 420 mg at dose level 3 or 100 mg/m^2 and pertuzumab 420 mg at dose level 4 until DLTs were observed.
25629|NCT02490475|E4|Reported Event|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25630|NCT02490475|E3|Reported Event|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25631|NCT02490475|E2|Reported Event|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25632|NCT02490475|E1|Reported Event|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
25633|NCT02490293|B3|Baseline|Total|Total of all reporting groups
25634|NCT02490293|B2|Baseline|Group B (Placebo)|"During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days.~Placebo: During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days."
25635|NCT02490293|B1|Baseline|Group A (Cephalosporin)|"During the period of hospitalization, intake of active drug ('pacetin', 2nd generation cephalosporin). 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days.~Cephalosporin: During the hospitalization, intake of pacetin, 2nd generation cephalosporin. 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days."
25636|NCT02490293|P2|Participant Flow|Group B (Placebo)|"During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days.~Placebo: During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days."
25637|NCT02490293|P1|Participant Flow|Group A (Cephalosporin)|"During the period of hospitalization, intake of active drug ('pacetin', 2nd generation cephalosporin). 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days.~Cephalosporin: During the hospitalization, intake of pacetin, 2nd generation cephalosporin. 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days."
25638|NCT02490293|O2|Outcome|Group B (Placebo)|"During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days.~Placebo: During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days."
25639|NCT02490293|O1|Outcome|Group A (Cephalosporin)|"During the period of hospitalization, intake of active drug ('pacetin', 2nd generation cephalosporin). 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days.~Cephalosporin: During the hospitalization, intake of pacetin, 2nd generation cephalosporin. 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days."
25640|NCT02490293|O2|Outcome|Group B (Placebo)|"During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days.~Placebo: During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days."
25641|NCT02490293|O1|Outcome|Group A (Cephalosporin)|"During the period of hospitalization, intake of active drug ('pacetin', 2nd generation cephalosporin). 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days.~Cephalosporin: During the hospitalization, intake of pacetin, 2nd generation cephalosporin. 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days."
25642|NCT02490293|E2|Reported Event|Group B (Placebo)|"During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days.~Placebo: During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days."
25643|NCT02490293|E1|Reported Event|Group A (Cephalosporin)|"During the period of hospitalization, intake of active drug ('pacetin', 2nd generation cephalosporin). 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days.~Cephalosporin: During the hospitalization, intake of pacetin, 2nd generation cephalosporin. 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days."
25644|NCT02489799|B3|Baseline|Total|Total of all reporting groups
25645|NCT02489799|B2|Baseline|Control|"Control video - no advance care planning content~Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
25646|NCT02489799|B1|Baseline|Intervention|"Advance care planning video~Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
25647|NCT02489799|P2|Participant Flow|Control|"Control video - no advance care planning content~Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
25648|NCT02489799|P1|Participant Flow|Intervention|"Advance care planning video~Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
25649|NCT02489799|O2|Outcome|Control|"Control video - no advance care planning content~Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
25650|NCT02489799|O1|Outcome|Intervention|"Advance care planning video~Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
25651|NCT02489799|O2|Outcome|Control|"Control video - no advance care planning content~Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
25652|NCT02489799|O1|Outcome|Intervention|"Advance care planning video~Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
25653|NCT02489799|O2|Outcome|Control|"Control video - no advance care planning content~Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
25654|NCT02489799|O1|Outcome|Intervention|"Advance care planning video~Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
25655|NCT02489799|O2|Outcome|Control|"Control video - no advance care planning content~Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
25656|NCT02489799|O1|Outcome|Intervention|"Advance care planning video~Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
25657|NCT02489799|O2|Outcome|Control|"Control video - no advance care planning content~Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
25773|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
36463|NCT02389088|O1|Outcome|Phase I - Week 0 - 24 Hours|
25658|NCT02489799|O1|Outcome|Intervention|"Advance care planning video~Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
25659|NCT02489799|O2|Outcome|Control|"Control video - no advance care planning content~Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
25660|NCT02489799|O1|Outcome|Intervention|"Advance care planning video~Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
25661|NCT02489799|O2|Outcome|Control|"Control video - no advance care planning content~Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
25662|NCT02489799|O1|Outcome|Intervention|"Advance care planning video~Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
25663|NCT02489799|O2|Outcome|Control|"Control video - no advance care planning content~Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
25664|NCT02489799|O1|Outcome|Intervention|"Advance care planning video~Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
25665|NCT02489799|O2|Outcome|Control|"Control video - no advance care planning content~Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
25666|NCT02489799|O1|Outcome|Intervention|"Advance care planning video~Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
25667|NCT02489799|O2|Outcome|Control|"Control video - no advance care planning content~Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
25668|NCT02489799|O1|Outcome|Intervention|"Advance care planning video~Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
25669|NCT02489799|E2|Reported Event|Control|"Control video - no advance care planning content~Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
25670|NCT02489799|E1|Reported Event|Intervention|"Advance care planning video~Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
25671|NCT02488980|B4|Baseline|Total|Total of all reporting groups
25672|NCT02488980|B3|Baseline|Mefloquine|"Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.~Mefloquine: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks."
25673|NCT02488980|B2|Baseline|Tafenoquine|"Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.~Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks."
25674|NCT02488980|B1|Baseline|Placebo|"Placebo~Placebo: Placebo for three days followed by placebo once a week for 24 weeks"
25675|NCT02488980|P3|Participant Flow|Placebo|"Placebo~Placebo: Placebo for three days followed by placebo once a week for 24 weeks"
25676|NCT02488980|P2|Participant Flow|Mefloquine|"Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.~Mefloquine: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks."
25677|NCT02488980|P1|Participant Flow|Tafenoquine|"Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.~Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks."
25678|NCT02488980|O3|Outcome|Mefloquine|"Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.~Mefloquine: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks."
25720|NCT02488070|O1|Outcome|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
25679|NCT02488980|O2|Outcome|Tafenoquine|"Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.~Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks."
25680|NCT02488980|O1|Outcome|Placebo|"Placebo~Placebo: Placebo for three days followed by placebo once a week for 24 weeks"
25681|NCT02488980|O3|Outcome|Mefloquine|"Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.~Mefloquine: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks."
25682|NCT02488980|O2|Outcome|Tafenoquine|"Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.~Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks."
25683|NCT02488980|O1|Outcome|Placebo|"Placebo~Placebo: Placebo for three days followed by placebo once a week for 24 weeks"
25684|NCT02488980|O3|Outcome|Mefloquine|"Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.~Mefloquine: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks."
25685|NCT02488980|O2|Outcome|Tafenoquine|"Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.~Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks."
25686|NCT02488980|O1|Outcome|Placebo|"Placebo~Placebo: Placebo for three days followed by placebo once a week for 24 weeks"
25687|NCT02488980|O3|Outcome|Mefloquine|"Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.~Mefloquine: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks."
25688|NCT02488980|O2|Outcome|Tafenoquine|"Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.~Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks."
25689|NCT02488980|O1|Outcome|Placebo|"Placebo~Placebo: Placebo for three days followed by placebo once a week for 24 weeks"
25690|NCT02488980|E3|Reported Event|Mefloquine|"Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.~Mefloquine: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks."
25691|NCT02488980|E2|Reported Event|Tafenoquine|"Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.~Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks."
25692|NCT02488980|E1|Reported Event|Placebo|"Placebo~Placebo: Placebo for three days followed by placebo once a week for 24 weeks"
25693|NCT02488681|B1|Baseline|Micra Pacemaker Implant|All subjects who attempted Micra implant procedure
25694|NCT02488681|P1|Participant Flow|Micra Pacemaker Implant|Patients who underwent a Micra implant attempt
25695|NCT02488681|O1|Outcome|Micra Pacemaker Implant|All subjects who attempted Micra implant procedure
25696|NCT02488681|E1|Reported Event|Micra Pacemaker Implant|All subjects who attempted Micra implant procedure
25697|NCT02488317|B3|Baseline|Total|Total of all reporting groups
25698|NCT02488317|B2|Baseline|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
25699|NCT02488317|B1|Baseline|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
25700|NCT02488317|P2|Participant Flow|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
25701|NCT02488317|P1|Participant Flow|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
25702|NCT02488317|O1|Outcome|Intervention Post-test|Intervention arm after reviewing the decision aid
25703|NCT02488317|O2|Outcome|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
25721|NCT02488070|E1|Reported Event|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
25774|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25775|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25704|NCT02488317|O1|Outcome|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
25705|NCT02488317|O2|Outcome|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
25706|NCT02488317|O1|Outcome|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
25707|NCT02488317|O2|Outcome|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
25708|NCT02488317|O1|Outcome|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
25709|NCT02488317|O3|Outcome|Control|Control arm with no decision aid.
25710|NCT02488317|O2|Outcome|Intervention Post-test|Intervention arm responses after accessing the decision aid (N=63)
25711|NCT02488317|O1|Outcome|Intervention Pre-test|Intervention arm responses prior to accessing the decision aid (N=70)
25712|NCT02488317|E2|Reported Event|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
25713|NCT02488317|E1|Reported Event|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
25714|NCT02488070|B1|Baseline|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
25715|NCT02488070|P1|Participant Flow|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|"Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.~Computed Tomography: Undergo PET/CT~Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx): Given IV~Laboratory Biomarker Analysis: Correlative studies~Magnetic Resonance Imaging: Undergo PET/MRI~Positron Emission Tomography: Undergo PET/CT~Positron Emission Tomography: Undergo PET/MRI"
25716|NCT02488070|O1|Outcome|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
25717|NCT02488070|O1|Outcome|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|"Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.~Computed Tomography: Part of PET/CT scan~Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx): Intravenously-administered (IV) radioisotope~Magnetic Resonance Imaging: Part of PET/MRI scan~Positron Emission Tomography: Part of PET/CT and/or PET/MRI scans"
25718|NCT02488070|O1|Outcome|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|"Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.~Computed Tomography: Part of PET/CT scan~Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx): Intravenously-administered (IV) radioisotope~Magnetic Resonance Imaging: Part of PET/MRI scan~Positron Emission Tomography: Part of PET/CT and/or PET/MRI scans"
25719|NCT02488070|O1|Outcome|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|"Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.~Computed Tomography: Part of PET/CT scan~Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx): Intravenously-administered (IV) radioisotope~Magnetic Resonance Imaging: Part of PET/MRI scan~Positron Emission Tomography: Part of PET/CT and/or PET/MRI scans"
25722|NCT02488018|B1|Baseline|Provision of Experimental Honeys|Monofloral honeys, namely: Acacia, Becium grandiflorum, Croton macrostachys, Eucalyptus globules, Hypoestes, Leaucas abyssinica, Schefflera abyssinica, Syzygium guineense collected from honey productive areas; and reference glucose were used as a test food. 25g available carbohydrate of the test foods was provided to all ten human subjects after fasted for 11 hours overnight. After fasting blood sample was collected from the finger. Additional blood samples were taken at 15, 30, 45, 60, 90 and 120 minutes. Glucose concentration of blood samples was used to draw a two-hour blood glucose response curve. Area under curve (AUC) for test food and reference glucose was calculated by trapezoidal rule.
25723|NCT02488018|P1|Participant Flow|Honey Glycemic Index|"Study participants were given 25g available carbohydrate of reference glucose or monofloral honeys of Acacia, Becium grandiflorum, Croton macrostachys, Eucalyptus globules, Hypoestes, Leaucas abyssinica, Schefflera abyssinica, Syzygium guineense in 250 mL of water, after they have fasted for 11 hours overnight.~Monofloral honeys, namely: collected from honey productive areas; and reference glucose were used as a test food. 25g available carbohydrate of the test foods was provided to all ten human subjects after fasted for 11 hours overnight. After fasting blood sample was collected from the finger. Additional blood samples were taken at 15, 30, 45, 60, 90 and 120 minutes. Glucose concentration of blood samples was used to draw a two-hour blood glucose response curve. Area under curve (AUC) for test food and reference glucose was calculated by trapezoidal rule."
25724|NCT02488018|O1|Outcome|Provision of Experimental Honeys|"Monofloral honeys, namely: Acacia, Becium grandiflorum, Croton macrostachys, Eucalyptus globules, Hypoestes, Leaucas abyssinica, Schefflera abyssinica, Syzygium guineense collected from honey productive areas; and reference glucose were used as a test food.~25g available carbohydrate of the test foods was provided to ten human subjects after fasted for 11 hours overnight. After fasting blood sample was collected from the finger. Additional blood samples were taken at 15, 30, 45, 60, 90 and 120 minutes. Glucose concentration of blood samples was used to draw a two-hour blood glucose response curve. Area under curve (AUC) for test food and reference glucose was calculated by trapezoidal rule."
25725|NCT02488018|E1|Reported Event|Honey Glycemic Index|Study participants were given 25g available carbohydrate of reference glucose or honey in 250 mL of water, after they have fasted for 11 hours overnight.
25726|NCT02487771|B3|Baseline|Total|Total of all reporting groups
25727|NCT02487771|B2|Baseline|DHA Capsule|DHA: 600 mg DHA capsule
25728|NCT02487771|B1|Baseline|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25729|NCT02487771|P2|Participant Flow|DHA Capsule|DHA: 600 mg DHA capsule
25730|NCT02487771|P1|Participant Flow|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25731|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25732|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25733|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25734|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25735|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25736|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25737|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25738|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25739|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25740|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25741|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25742|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25743|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25744|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25745|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25746|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25747|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25748|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25749|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25750|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25751|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25752|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25753|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25754|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25755|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25756|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25757|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25758|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25759|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25760|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25761|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25762|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25763|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25764|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25765|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25766|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25767|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25768|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25776|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25777|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25778|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25779|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25780|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25781|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25782|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25783|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25784|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25785|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25786|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25787|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25788|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25789|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25790|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25791|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25792|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25793|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25794|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25795|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25796|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25797|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25798|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25799|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25800|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25801|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25802|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25803|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25804|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25805|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25806|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25807|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25808|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25809|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25810|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25811|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25812|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25813|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25814|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25815|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25816|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25817|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25818|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25819|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25820|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25821|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25822|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25823|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25824|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25825|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25826|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25827|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25828|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25829|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25830|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25831|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25832|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25833|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25834|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25835|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25836|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25837|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25838|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25839|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25840|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25842|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25843|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25844|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25845|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25846|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25847|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25848|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25849|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25850|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25851|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25852|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25853|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25854|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25855|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25856|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25857|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25858|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25859|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25860|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25861|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25862|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25863|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25864|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25865|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25866|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25867|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25868|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25869|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25870|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25871|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25872|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25873|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25874|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25875|NCT02487771|O2|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
25876|NCT02487771|O1|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25877|NCT02487771|E2|Reported Event|DHA Capsule|DHA: 600 mg DHA capsule
25878|NCT02487771|E1|Reported Event|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
25879|NCT02487498|B1|Baseline|Overall Participants|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks and Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
25880|NCT02487498|P2|Participant Flow|First Umeclidinium/Vilanterol, Then QVA149|Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. Then after 3 weeks washout, participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
25881|NCT02487498|P1|Participant Flow|First QVA149, Then Umeclidinium/Vilanterol|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
25882|NCT02487498|O2|Outcome|First Umeclidinium/Vilanterol, Then QVA149|Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. Then after 3 weeks washout, participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
25883|NCT02487498|O1|Outcome|First QVA149, Then Umeclidinium/Vilanterol|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
25884|NCT02487498|O2|Outcome|First Umeclidinium/Vilanterol, Then QVA149|Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. Then after 3 weeks washout, participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
25885|NCT02487498|O1|Outcome|First QVA149, Then Umeclidinium/Vilanterol|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
25886|NCT02487498|O2|Outcome|First Umeclidinium/Vilanterol, Then QVA149|Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. Then after 3 weeks washout, participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
25887|NCT02487498|O1|Outcome|First QVA149, Then Umeclidinium/Vilanterol|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
25888|NCT02487498|O2|Outcome|First Umeclidinium/Vilanterol, Then QVA149|Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. Then after 3 weeks washout, participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
25889|NCT02487498|O1|Outcome|First QVA149, Then Umeclidinium/Vilanterol|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
25890|NCT02487498|O2|Outcome|First Umeclidinium/Vilanterol, Then QVA149|Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. Then after 3 weeks washout, participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
25891|NCT02487498|O1|Outcome|First QVA149, Then Umeclidinium/Vilanterol|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
25892|NCT02487498|O2|Outcome|First Umeclidinium/Vilanterol, Then QVA149|Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. Then after 3 weeks washout, participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
25893|NCT02487498|O1|Outcome|First QVA149, Then Umeclidinium/Vilanterol|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
25894|NCT02487498|O2|Outcome|First Umeclidinium/Vilanterol, Then QVA149|Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. Then after 3 weeks washout, participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
25895|NCT02487498|O1|Outcome|First QVA149, Then Umeclidinium/Vilanterol|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
25896|NCT02487498|O2|Outcome|First Umeclidinium/Vilanterol, Then QVA149|Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. Then after 3 weeks washout, participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
25897|NCT02487498|O1|Outcome|First QVA149, Then Umeclidinium/Vilanterol|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
25898|NCT02487498|O2|Outcome|First Umeclidinium/Vilanterol, Then QVA149|Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. Then after 3 weeks washout, participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
25899|NCT02487498|O1|Outcome|First QVA149, Then Umeclidinium/Vilanterol|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
25900|NCT02487498|E3|Reported Event|All Patients|All Patients
25901|NCT02487498|E2|Reported Event|U/V 62.5/25 od|Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
25902|NCT02487498|E1|Reported Event|QVA 27.5/12.5 Bid|QVA149 capsules for inhalation, delivered via QVA149 SDDPI
25903|NCT02487446|B1|Baseline|Overall Participants|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks and Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
25904|NCT02487446|P2|Participant Flow|First Umeclidinium/Vilanterol, Then QVA149|Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. Then after 3 weeks washout, participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
25905|NCT02487446|P1|Participant Flow|First QVA149, Then Umeclidinium/Vilanterol|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
25906|NCT02487446|O2|Outcome|Umeclidinium/Vilanterol|Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation b.i.d. for 12 weeks.
25907|NCT02487446|O1|Outcome|QVA149|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
25908|NCT02487446|O2|Outcome|Umeclidinium/Vilanterol|Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation b.i.d. for 12 weeks.
25909|NCT02487446|O1|Outcome|QVA149|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
25910|NCT02487446|O2|Outcome|Umeclidinium/Vilanterol|Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation b.i.d. for 12 weeks.
25911|NCT02487446|O1|Outcome|QVA149|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
25912|NCT02487446|O2|Outcome|Umeclidinium/Vilanterol|Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation b.i.d. for 12 weeks.
25913|NCT02487446|O1|Outcome|QVA149|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
25914|NCT02487446|O2|Outcome|Umeclidinium/Vilanterol|Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation b.i.d. for 12 weeks.
25915|NCT02487446|O1|Outcome|QVA149|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
25916|NCT02487446|O2|Outcome|Umeclidinium/Vilanterol|Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation b.i.d. for 12 weeks.
25917|NCT02487446|O1|Outcome|QVA149|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
25918|NCT02487446|O2|Outcome|Umeclidinium/Vilanterol|Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation b.i.d. for 12 weeks.
25919|NCT02487446|O1|Outcome|QVA149|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
25920|NCT02487446|O2|Outcome|Umeclidinium/Vilanterol|Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation b.i.d. for 12 weeks.
25921|NCT02487446|O1|Outcome|QVA149|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
25922|NCT02487446|O2|Outcome|Umeclidinium/Vilanterol|Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation b.i.d. for 12 weeks.
25923|NCT02487446|O1|Outcome|QVA149|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
25924|NCT02487446|E3|Reported Event|All Patients|All Patients
25925|NCT02487446|E2|Reported Event|Umeclidinium/Vilanterol|Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation b.i.d. for 12 weeks.
25926|NCT02487446|E1|Reported Event|QVA149|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
25927|NCT02487199|B3|Baseline|Total|Total of all reporting groups
26768|NCT02480582|O2|Outcome|Cheese Savouries|Sainsbury's savoury biscuits Cheese Savouries
25928|NCT02487199|B2|Baseline|HCV GT4 (2-DAA)|Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks.
25929|NCT02487199|B1|Baseline|HCV GT1a (3-DAA)|Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
25930|NCT02487199|P2|Participant Flow|HCV GT4 (2-DAA)|Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks.
25931|NCT02487199|P1|Participant Flow|HCV GT1a (3-DAA)|Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
25932|NCT02487199|O2|Outcome|HCV GT4 (2-DAA)|Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks.
25933|NCT02487199|O1|Outcome|HCV GT1a (3-DAA)|Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
25934|NCT02487199|O2|Outcome|HCV GT4 (2-DAA)|Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks.
25935|NCT02487199|O1|Outcome|HCV GT1a (3-DAA)|Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
25936|NCT02487199|O2|Outcome|HCV GT4 (2-DAA)|Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks.
25937|NCT02487199|O1|Outcome|HCV GT1a (3-DAA)|Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
25938|NCT02487199|O2|Outcome|HCV GT4 (2-DAA)|Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks.
25939|NCT02487199|O1|Outcome|HCV GT1a (3-DAA)|Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
25940|NCT02487199|E2|Reported Event|HCV GT4 (2-DAA)|Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks.
25941|NCT02487199|E1|Reported Event|HCV GT1a (3-DAA)|Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
25942|NCT02487030|B8|Baseline|Total|Total of all reporting groups
25943|NCT02487030|B7|Baseline|LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in SOF or LDV/SOF experienced participants. Participants who completed treatment in Study GS-US-334-0138 with SOF+RBV for 12 or 24 weeks or those who participated in Cohort 1 of this study with LDV/SOF ± RBV for 8 weeks and did not achieve SVR12 were enrolled into Cohort 2.
25944|NCT02487030|B6|Baseline|LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TE participants
25945|NCT02487030|B5|Baseline|LDV/SOF 12 wk TE (Cohort 3, Group 1)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily in TE participants
25946|NCT02487030|B4|Baseline|LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TN participants
25947|NCT02487030|B3|Baseline|LDV/SOF 12 wk TN (Cohort 1, Group 3)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks in TN participants
25948|NCT02487030|B2|Baseline|LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks in TN participants
25949|NCT02487030|B1|Baseline|LDV/SOF 8 wk TN (Cohort 1, Group 1)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 8 weeks in TN participants
25950|NCT02487030|P7|Participant Flow|LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in SOF or LDV/SOF experienced participants. Participants who completed treatment in Study GS-US-334-0138 with SOF+RBV for 12 or 24 weeks or those who participated in Cohort 1 of this study with LDV/SOF ± RBV for 8 weeks and did not achieve SVR12 were in enrolled into Cohort 2.
25951|NCT02487030|P6|Participant Flow|LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TE participants
25952|NCT02487030|P5|Participant Flow|LDV/SOF 12 wk TE (Cohort 3, Group 1)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily in treatment-experienced (TE) participants
25953|NCT02487030|P4|Participant Flow|LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TN participants
25954|NCT02487030|P3|Participant Flow|LDV/SOF 12 wk TN (Cohort 1, Group 3)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks in TN participants
26769|NCT02480582|O1|Outcome|Almonds|Whole, raw almonds Almonds
25955|NCT02487030|P2|Participant Flow|LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + Ribavirin (RBV) tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks in TN participants
25956|NCT02487030|P1|Participant Flow|LDV/SOF 8 wk TN (Cohort 1, Group 1)|Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed dose combination (FDC) tablet administered orally once daily for 8 weeks (wk) in treatment-naive (TN) participants
25957|NCT02487030|O7|Outcome|LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in SOF or LDV/SOF experienced participants. Participants who completed treatment in Study GS-US-334-0138 with SOF+RBV for 12 or 24 weeks or those who participated in Cohort 1 of this study with LDV/SOF ± RBV for 8 weeks and did not achieve SVR12 were enrolled into Cohort 2.
25958|NCT02487030|O6|Outcome|LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TE participants
25959|NCT02487030|O5|Outcome|LDV/SOF 12 wk TE (Cohort 3, Group 1)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily in TE participants
25960|NCT02487030|O4|Outcome|LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TN participants
25961|NCT02487030|O3|Outcome|LDV/SOF 12 wk TN (Cohort 1, Group 3)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks in TN participants
25962|NCT02487030|O2|Outcome|LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks in TN participants
25963|NCT02487030|O1|Outcome|LDV/SOF 8 wk TN (Cohort 1, Group 1)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 8 weeks in TN participants
25964|NCT02487030|O7|Outcome|LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in SOF or LDV/SOF experienced participants. Participants who completed treatment in Study GS-US-334-0138 with SOF+RBV for 12 or 24 weeks or those who participated in Cohort 1 of this study with LDV/SOF ± RBV for 8 weeks and did not achieve SVR12 were enrolled into Cohort 2.
25965|NCT02487030|O6|Outcome|LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TE participants
25966|NCT02487030|O5|Outcome|LDV/SOF 12 wk TE (Cohort 3, Group 1)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily in TE participants
25967|NCT02487030|O4|Outcome|LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TN participants
25968|NCT02487030|O3|Outcome|LDV/SOF 12 wk TN (Cohort 1, Group 3)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks in TN participants
25969|NCT02487030|O2|Outcome|LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks in TN participants
25970|NCT02487030|O1|Outcome|LDV/SOF 8 wk TN (Cohort 1, Group 1)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 8 weeks in TN participants
25971|NCT02487030|O4|Outcome|LDV/SOF + RBV 12 Weeks|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks
25972|NCT02487030|O3|Outcome|LDV/SOF 12 Weeks|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks
25973|NCT02487030|O2|Outcome|LDV/SOF + RBV 8 Weeks|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks
25974|NCT02487030|O1|Outcome|LDV/SOF 8 Weeks|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 8 weeks
25975|NCT02487030|O7|Outcome|LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in SOF or LDV/SOF experienced participants. Participants who completed treatment in Study GS-US-334-0138 with SOF+RBV for 12 or 24 weeks or those who participated in Cohort 1 of this study with LDV/SOF ± RBV for 8 weeks and did not achieve SVR12 were enrolled into Cohort 2.
25976|NCT02487030|O6|Outcome|LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TE participants
25977|NCT02487030|O5|Outcome|LDV/SOF 12 wk TE (Cohort 3, Group 1)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily in TE participants
25978|NCT02487030|O4|Outcome|LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TN participants
25979|NCT02487030|O3|Outcome|LDV/SOF 12 wk TN (Cohort 1, Group 3)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks in TN participants
25980|NCT02487030|O2|Outcome|LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks in TN participants
25981|NCT02487030|O1|Outcome|LDV/SOF 8 wk TN (Cohort 1, Group 1)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 8 weeks in TN participants
25982|NCT02487030|E4|Reported Event|LDV/SOF + RBV 12 Weeks|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks
26952|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
25983|NCT02487030|E3|Reported Event|LDV/SOF 12 Weeks|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks
25984|NCT02487030|E2|Reported Event|LDV/SOF + RBV 8 Weeks|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks
25985|NCT02487030|E1|Reported Event|LDV/SOF 8 Weeks|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 8 weeks
25986|NCT02486952|B1|Baseline|Diffuse Large B-Cell Lymphoma|Participants, who were not treated previously for DLBCL, and received rituximab in combination with CHOP or CHOP-like chemotherapy at the treating physician’s discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
25987|NCT02486952|P1|Participant Flow|Diffuse Large B-Cell Lymphoma|Participants, who were not treated previously for diffuse large B cell lymphoma (DLBCL), and received rituximab (MabThera) in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like chemotherapy at the treating physician’s discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
25988|NCT02486952|O1|Outcome|Diffuse Large B-Cell Lymphoma|Participants, who were not treated previously for DLBCL, and received rituximab in combination with CHOP or CHOP-like chemotherapy at the treating physician’s discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
25989|NCT02486952|O1|Outcome|Diffuse Large B-Cell Lymphoma|Participants, who were not treated previously for DLBCL, and received rituximab in combination with CHOP or CHOP-like chemotherapy at the treating physician’s discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
25990|NCT02486952|E1|Reported Event|Diffuse Large B-Cell Lymphoma|Participants, who were not treated previously for DLBCL, and received rituximab in combination with CHOP or CHOP-like chemotherapy at the treating physician’s discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
25991|NCT02485483|B3|Baseline|Total|Total of all reporting groups
25992|NCT02485483|B2|Baseline|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
25993|NCT02485483|B1|Baseline|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
25994|NCT02485483|P2|Participant Flow|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
25995|NCT02485483|P1|Participant Flow|VADERA I|Rheumatoid arthritis (RA) participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the World Health Organization Five Well-Being Index (WHO-5), Patient Health Questionnaire-9 (PHQ-9) and Beck Depression Inventory (2nd edition) (BDI-II) questionnaires and a subsequent structured interview using Montgomery-Åsberg Depression Rating Scale (MADRS) at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
25996|NCT02485483|O1|Outcome|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
25997|NCT02485483|O1|Outcome|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
25998|NCT02485483|O1|Outcome|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
25999|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
26000|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
26001|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
26002|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
26222|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
26003|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
26004|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
26005|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
26006|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
26007|NCT02485483|E2|Reported Event|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
26008|NCT02485483|E1|Reported Event|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
26009|NCT02485353|B1|Baseline|Vosaroxin and Cytarabine|Each cycle will include vosaroxin treatment on days 1 and 4 (total of 2 days) and cytarabine treatment on days 1-5 (total of 5 days) followed by a variable interval required to achieve hematologic recovery, defined as absolute neutrophil count (ANC) > 1000 cells/L
26010|NCT02485353|P1|Participant Flow|Vosaroxin and Cytarabine|Each cycle will include vosaroxin treatment on days 1 and 4 (total of 2 days) and cytarabine treatment on days 1-5 (total of 5 days) followed by a variable interval required to achieve hematologic recovery, defined as absolute neutrophil count (ANC) > 1000 cells/L
26011|NCT02485353|O1|Outcome|Vosaroxin and Cytarabine|Each cycle will include vosaroxin treatment on days 1 and 4 (total of 2 days) and cytarabine treatment on days 1-5 (total of 5 days) followed by a variable interval required to achieve hematologic recovery, defined as absolute neutrophil count (ANC) > 1000 cells/L
26012|NCT02485353|O1|Outcome|Vosaroxin and Cytarabine|Each cycle will include vosaroxin treatment on days 1 and 4 (total of 2 days) and cytarabine treatment on days 1-5 (total of 5 days) followed by a variable interval required to achieve hematologic recovery, defined as absolute neutrophil count (ANC) > 1000 cells/L
26013|NCT02485353|E1|Reported Event|Vosaroxin and Cytarabine|Each cycle will include vosaroxin treatment on days 1 and 4 (total of 2 days) and cytarabine treatment on days 1-5 (total of 5 days) followed by a variable interval required to achieve hematologic recovery, defined as absolute neutrophil count (ANC) > 1000 cells/L
26014|NCT02485301|B3|Baseline|Total|Total of all reporting groups
26015|NCT02485301|B2|Baseline|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
26016|NCT02485301|B1|Baseline|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
26017|NCT02485301|P2|Participant Flow|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
26018|NCT02485301|P1|Participant Flow|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
26019|NCT02485301|O2|Outcome|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
26020|NCT02485301|O1|Outcome|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
26021|NCT02485301|O2|Outcome|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
26022|NCT02485301|O1|Outcome|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
26023|NCT02485301|O2|Outcome|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
26024|NCT02485301|O1|Outcome|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
26025|NCT02485301|O2|Outcome|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
26953|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
26026|NCT02485301|O1|Outcome|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
26027|NCT02485301|O2|Outcome|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
26028|NCT02485301|O1|Outcome|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
26029|NCT02485301|O2|Outcome|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
26030|NCT02485301|O1|Outcome|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
26031|NCT02485301|O2|Outcome|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
26032|NCT02485301|O1|Outcome|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
26033|NCT02485301|O2|Outcome|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
26034|NCT02485301|O1|Outcome|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
26035|NCT02485301|O2|Outcome|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
26036|NCT02485301|O1|Outcome|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
26037|NCT02485301|O2|Outcome|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
26038|NCT02485301|O1|Outcome|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
26039|NCT02485301|O2|Outcome|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
26040|NCT02485301|O1|Outcome|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
26041|NCT02485301|O2|Outcome|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
26042|NCT02485301|O1|Outcome|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
26043|NCT02485301|O2|Outcome|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
26044|NCT02485301|O1|Outcome|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
26045|NCT02485301|O2|Outcome|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
26046|NCT02485301|O1|Outcome|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
26047|NCT02485301|O2|Outcome|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
26048|NCT02485301|O1|Outcome|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
26049|NCT02485301|O2|Outcome|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
26050|NCT02485301|O1|Outcome|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
26223|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
26051|NCT02485301|O2|Outcome|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
26052|NCT02485301|O1|Outcome|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
26053|NCT02485301|O2|Outcome|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
26054|NCT02485301|O1|Outcome|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
26055|NCT02485301|O2|Outcome|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
26056|NCT02485301|O1|Outcome|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
26057|NCT02485301|O2|Outcome|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
26058|NCT02485301|O1|Outcome|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
26059|NCT02485301|O2|Outcome|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
26060|NCT02485301|O1|Outcome|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
26061|NCT02485301|O2|Outcome|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
26062|NCT02485301|O1|Outcome|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
26063|NCT02485301|O2|Outcome|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
26064|NCT02485301|O1|Outcome|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
26065|NCT02485301|E2|Reported Event|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
26066|NCT02485301|E1|Reported Event|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
26067|NCT02485158|B1|Baseline|Healthy Adult Volunteers|All healthy adult volunteers completed a 6 session within-subject, double-blind, placebo-controlled trial. At three of these sessions, they received one of three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At each session, they received a capsule and a drink. At the amphetamine drug session, they received a capsule containing d-amphetamine and a placebo beverage. At the THC drug session, they received a capsule containing THC and a placebo beverage. At the alcohol drug session they received a placebo capsule and a beverage containing alcohol. At the three matched placebo sessions, both the capsule and the beverage were placebo.
26068|NCT02485158|P1|Participant Flow|Healthy Adult Volunteers|24 healthy adult volunteers completed a 6 session within-subject, double-blind, placebo-controlled trial. At three of these sessions, they received one of three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At each session, they received a capsule and a drink. At the amphetamine drug session, they received a capsule containing d-amphetamine and a placebo beverage. At the THC drug session, they received a capsule containing THC and a placebo beverage. At the alcohol drug session they received a placebo capsule and a beverage containing alcohol. At the three matched placebo sessions, both the capsule and the beverage were placebo.
26069|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
26070|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
26071|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
26218|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
26072|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
26073|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
26074|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
26075|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
26076|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
26077|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
26078|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
26079|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
26080|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
26081|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
26082|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
26083|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
26084|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
26085|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
26086|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
26087|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
26088|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
26089|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
26090|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
26091|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
26092|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
26219|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
26093|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
26094|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
26095|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
26096|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
26097|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
26098|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
26099|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
26100|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
26101|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
26102|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
26103|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
26104|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
26105|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
26106|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
26107|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
26108|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
26109|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
26110|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
26111|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
26112|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
26113|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
26220|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
26114|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
26115|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
26116|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
26117|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
26118|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
26119|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
26120|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
26121|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
26122|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
26123|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
26124|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
26125|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
26126|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
26127|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
26128|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
26129|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
26130|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
26131|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
26132|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
26133|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
26134|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
26221|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
26135|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
26136|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
26137|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
26138|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
26139|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
26140|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
26141|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
26142|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
26143|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
26144|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
26145|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
26146|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
26147|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
26148|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
26149|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
26150|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
26151|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
26152|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
26153|NCT02485158|E1|Reported Event|Healthy Adult Volunteers|24 healthy adult volunteers completed a 6 session within-subject, double-blind, placebo-controlled trial. At three of these sessions, they received one of three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At each session, they received a capsule and a drink. At the amphetamine drug session, they received a capsule containing d-amphetamine and a placebo beverage. At the THC drug session, they received a capsule containing THC and a placebo beverage. At the alcohol drug session they received a placebo capsule and a beverage containing alcohol. At the three matched placebo sessions, both the capsule and the beverage were placebo.
26154|NCT02484911|B3|Baseline|Total|Total of all reporting groups
26155|NCT02484911|B2|Baseline|Control Regimen|"Aprepitant in combination with palonosetron and dexamethasone~Aprepitant: 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.~Palonosetron: 0.25mg IV 30-60min before chemotherapy on day 1~Dexamethasone: 6mg IV on day 1 ，3.75mg IV on day 2 to 4"
26156|NCT02484911|B1|Baseline|Olanzapine Regimen|"Olanzapine in combination with aprepitant ,palonosetron and dexamethasone.~Olanzapine: 5mg,twice a day orally on day 1 to day 4~Aprepitant: 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.~Palonosetron: 0.25mg IV 30-60min before chemotherapy on day 1~Dexamethasone: 6mg IV on day 1 ，3.75mg IV on day 2 to 4"
26157|NCT02484911|P2|Participant Flow|Control Regimen|"Aprepitant in combination with palonosetron and dexamethasone~Aprepitant: 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.~Palonosetron: 0.25mg IV 30-60min before chemotherapy on day 1~Dexamethasone: 6mg IV on day 1 ，3.75mg IV on day 2 to 4"
26158|NCT02484911|P1|Participant Flow|Olanzapine Regimen|"Olanzapine in combination with aprepitant ,palonosetron and dexamethasone.~Olanzapine: 5mg,twice a day orally on day 1 to day 4~Aprepitant: 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.~Palonosetron: 0.25mg IV 30-60min before chemotherapy on day 1~Dexamethasone: 6mg IV on day 1 ，3.75mg IV on day 2 to 4"
26159|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
26160|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
26161|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
26162|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
26163|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
26164|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
26165|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
26166|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
26167|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
26168|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
26169|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
26170|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
26171|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
26172|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
26173|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
26174|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
26175|NCT02484911|O2|Outcome|Aprepitant Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
26176|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
26177|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
26178|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
26179|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
26180|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
26181|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
26182|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
26183|NCT02484911|E2|Reported Event|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
26184|NCT02484911|E1|Reported Event|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
26185|NCT02484898|B1|Baseline|SEEQ™ MCT/ECM System|SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias.
26186|NCT02484898|P1|Participant Flow|SEEQ™ MCT/ECM System|SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias.
26187|NCT02484898|O1|Outcome|SEEQ™ MCT/ECM System|SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias.
26188|NCT02484898|E1|Reported Event|SEEQ™ MCT/ECM System|SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias.
26189|NCT02484729|B11|Baseline|Total|Total of all reporting groups
26190|NCT02484729|B10|Baseline|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
26191|NCT02484729|B9|Baseline|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
26192|NCT02484729|B8|Baseline|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
26193|NCT02484729|B7|Baseline|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
26194|NCT02484729|B6|Baseline|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
26195|NCT02484729|B5|Baseline|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
26196|NCT02484729|B4|Baseline|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
26197|NCT02484729|B3|Baseline|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
26198|NCT02484729|B2|Baseline|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
26199|NCT02484729|B1|Baseline|Part A- Placebo|Subjects received matching placebo under fasted conditions
26200|NCT02484729|P10|Participant Flow|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
26201|NCT02484729|P9|Participant Flow|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
26202|NCT02484729|P8|Participant Flow|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
26203|NCT02484729|P7|Participant Flow|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
26204|NCT02484729|P6|Participant Flow|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
26205|NCT02484729|P5|Participant Flow|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
26206|NCT02484729|P4|Participant Flow|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
26207|NCT02484729|P3|Participant Flow|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
26208|NCT02484729|P2|Participant Flow|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
26209|NCT02484729|P1|Participant Flow|Part A- Placebo|Subjects received matching placebo under fasted conditions
26210|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
26211|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
26212|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
26213|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
26214|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
26215|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
26216|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
26217|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
26224|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
26225|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
26226|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
26227|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
26228|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
26229|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
26230|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
26231|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
26232|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
26233|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
26234|NCT02484729|O10|Outcome|Oral Suspension (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
26235|NCT02484729|O9|Outcome|Intellicap Device (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
26236|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
26237|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
26238|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
26239|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
26240|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
26241|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
26242|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
26243|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
26244|NCT02484729|O10|Outcome|Oral Suspension (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
26245|NCT02484729|O9|Outcome|Intellicap Device (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
26246|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
26247|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
26248|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
26249|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
26250|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
26251|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
26252|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
26253|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
26254|NCT02484729|O10|Outcome|Oral Suspension (Part B)|
26255|NCT02484729|O9|Outcome|Intellicap Device (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
26256|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
26257|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
26258|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
26259|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
26260|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
26261|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
26262|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
26263|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
26264|NCT02484729|O10|Outcome|Oral Suspension (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
26265|NCT02484729|O9|Outcome|Intellicap Device (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
26266|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
26267|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
26954|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
26268|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
26269|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
26270|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
26271|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
26272|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
26273|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
26274|NCT02484729|O10|Outcome|Oral Suspension (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
26275|NCT02484729|O9|Outcome|Intellicap Device (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
26276|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
26277|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
26278|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
26279|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
26280|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
26281|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
26282|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
26283|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
26284|NCT02484729|O10|Outcome|Oral Suspension (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
26285|NCT02484729|O9|Outcome|Intellicap Device (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
26286|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
26287|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
26288|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
26289|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
26290|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
26291|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
26292|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
26293|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
26294|NCT02484729|O10|Outcome|Oral Suspension (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
26295|NCT02484729|O9|Outcome|Intellicap Device (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
26296|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
26297|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
26298|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
26299|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
26300|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
26301|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
26302|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
26303|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
26304|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
26305|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
26306|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
26307|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
26308|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
26309|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
26310|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
26311|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
26955|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
26312|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
26313|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
26314|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
26315|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
26316|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
26317|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
26318|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
26319|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
26320|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
26321|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
26322|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
26323|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
26324|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
26325|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
26326|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
26327|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
26328|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
26329|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
26330|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
26331|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
26332|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
26333|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
26334|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
26335|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
26336|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
26337|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
26338|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
26339|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
26340|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
26341|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
26342|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
26343|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
26344|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
26345|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
26346|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
26347|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
26348|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
26349|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
26350|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
26351|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
26352|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
26353|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
26354|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
26355|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
26356|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
26357|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
26358|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
26359|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
26360|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
26361|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
26362|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
26363|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
26364|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
26365|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
26366|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
26367|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
26368|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
26369|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
26370|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
26371|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
26372|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
26373|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
26374|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
26375|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
26376|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
26377|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
26378|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
26379|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
26380|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
26381|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
26382|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
26383|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
26384|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
26385|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
26386|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
26387|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
26388|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
26389|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
26390|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
26391|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
26392|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
26393|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
26394|NCT02484729|E10|Reported Event|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
26395|NCT02484729|E9|Reported Event|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
26396|NCT02484729|E8|Reported Event|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
26397|NCT02484729|E7|Reported Event|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
26398|NCT02484729|E6|Reported Event|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
26399|NCT02484729|E5|Reported Event|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
26400|NCT02484729|E4|Reported Event|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
26401|NCT02484729|E3|Reported Event|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
26402|NCT02484729|E2|Reported Event|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
26403|NCT02484729|E1|Reported Event|Part A- Placebo|Subjects received matching placebo under fasted conditions
26404|NCT02483975|B3|Baseline|Total|Total of all reporting groups
26405|NCT02483975|B2|Baseline|Placebo|Par. received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Participants also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
26406|NCT02483975|B1|Baseline|Fluticasone Furoate 50 mcg|Par. received one inhalation, once daily of FF 50 mcg in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
26407|NCT02483975|P2|Participant Flow|Placebo|Par. received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
26408|NCT02483975|P1|Participant Flow|Fluticasone Furoate 50 mcg|Par. received one inhalation, once daily of FF 50 microgram (mcg) in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
26409|NCT02483975|O2|Outcome|Placebo|Participants received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Participants also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
26410|NCT02483975|O1|Outcome|Fluticasone Furoate 50 mcg|Participants received one inhalation, once daily of FF 50 mcg in the morning via ELLIPTA inhaler for 6 wks. Participants also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
26411|NCT02483975|O2|Outcome|Placebo|Par. received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Par also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
26412|NCT02483975|O1|Outcome|Fluticasone Furoate 50 mcg|Par. received one inhalation, once daily of FF 50 mcg in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
26413|NCT02483975|O2|Outcome|Placebo|Par. received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
26414|NCT02483975|O1|Outcome|Fluticasone Furoate 50 mcg|Par. received one inhalation, once daily of FF 50 mcg in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
26415|NCT02483975|O2|Outcome|Placebo|Par. received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
26416|NCT02483975|O1|Outcome|Fluticasone Furoate 50 mcg|Par. received one inhalation, once daily of FF 50 mcg in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
26417|NCT02483975|O2|Outcome|Placebo|Par. received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
26418|NCT02483975|O1|Outcome|Fluticasone Furoate 50 mcg|Par. received one inhalation, once daily of FF 50 mcg in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
26419|NCT02483975|E2|Reported Event|Placebo|Participants received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Participants also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
26420|NCT02483975|E1|Reported Event|Fluticasone Furoate 50 mcg|Participants received one inhalation, once daily of FF 50 mcg in the morning via ELLIPTA inhaler for 6 wks. Participants also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
26421|NCT02483611|B4|Baseline|Total|Total of all reporting groups
26422|NCT02483611|B3|Baseline|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26423|NCT02483611|B2|Baseline|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26424|NCT02483611|B1|Baseline|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26425|NCT02483611|P3|Participant Flow|Group C (Control Group - Isotonic Solution)|This group received isotonic solution in a equivalent volume as a bolus over 5 minutes, followed by continuous intravenous infusion of isotonic solution during the surgery.
26426|NCT02483611|P2|Participant Flow|Group ML (Magnesium Sulfate Plus Lidocaine)|This group received Magnesium Sulfate (MS) 40 mg/kg plus lidocaine 3 mg/kg as a bolus over 5 minutes, followed by continuous intravenous infusion of MS 20 mg/kg/h plus lidocaine 3 mg/kg/h during the surgery.
26427|NCT02483611|P1|Participant Flow|Group M (Magnesium Sulfate)|This group received Magnesium Sulfate (MS) 40 mg/kg as a bolus over 5 minutes, followed by continuous intravenous infusion of MS 20 mg/kg/h during the surgery.
26428|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26429|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26577|NCT02482428|O5|Outcome|Aldara|Aldara 5% cream 3 applications per week for a maximum of 16 weeks
26430|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26431|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26432|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26433|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26434|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26435|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26436|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26437|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26438|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26439|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26440|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26441|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26442|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26443|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26444|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26445|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26446|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26447|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26448|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26449|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26450|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26451|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26452|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26453|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26454|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26455|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26456|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26457|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26458|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26459|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26956|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
26460|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26461|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26462|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26463|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26464|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26465|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26466|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26467|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26468|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26469|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26470|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26471|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26472|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26473|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26474|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26475|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26476|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26477|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26478|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26479|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26480|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26481|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26482|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26483|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26484|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26485|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26486|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26487|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26488|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26489|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26957|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
26490|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26491|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26492|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26493|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26494|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26495|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26496|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26497|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26498|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26499|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26500|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26501|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26502|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26503|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26504|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26505|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26506|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26507|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26508|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26509|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26510|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26511|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26512|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26513|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26514|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26515|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26516|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26517|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26518|NCT02483611|E3|Reported Event|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
26519|NCT02483611|E2|Reported Event|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
26958|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
26520|NCT02483611|E1|Reported Event|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
26521|NCT02482870|B1|Baseline|All Study Participants|Each patient were intubated with both Macintosh and King Vision video laryngoscope sequentially. The order of the laryngoscopes was randomized by flipping a coin.
26522|NCT02482870|P2|Participant Flow|King Vision First, Then Macintosh|The patients has been intubated first with a King Vision video laryngoscope, then with a Macintosh laryngoscope.
26523|NCT02482870|P1|Participant Flow|Macintosh First, Then King Vision|The patients has been intubated first with a Macintosh, then with a King Vision video laryngoscope.
26524|NCT02482870|O2|Outcome|King Vision Video Laryngoscope|Airway complications related to the use of King Vision video laryngoscope has been recorded.
26525|NCT02482870|O1|Outcome|Macintosh|Airway complications related to the use of Macintosh laryngoscope has been recorded.
26526|NCT02482870|O2|Outcome|King Vision Video Laryngoscope|Using a King Vision video laryngoscope, best Cormack-Lehane score obtained has been recorded.
26527|NCT02482870|O1|Outcome|Macintosh|Using a Macintosh laryngoscope, best Cormack-Lehane score obtained has been recorded.
26528|NCT02482870|O2|Outcome|King Vision Video Laryngoscope|Using a King Vision video laryngoscope, glottic view time has been recorded.
26529|NCT02482870|O1|Outcome|Macintosh|Using a Macintosh laryngoscope, glottic view time has been recorded.
26530|NCT02482870|O2|Outcome|King Vision Video Laryngoscope|Using a King Vision video laryngoscope, intubation time has been recorded.
26531|NCT02482870|O1|Outcome|Macintosh|Using a Macintosh laryngoscope, intubation time has been recorded.
26532|NCT02482870|O2|Outcome|King Vision Video Laryngoscope|Using a King Vision video laryngoscope, first pass intubation success rate has been recorded.
26533|NCT02482870|O1|Outcome|Macintosh|Using a Macintosh laryngoscope, first pass intubation success rate has been recorded.
26534|NCT02482870|E2|Reported Event|Macintosh First, Then King Vision|These patients had been intubated with a Macintosh laryngoscope first, and then with a King Vision video laryngoscope. Airway complications related to the laryngoscopy and intubation (cuts, bleeding, damage to the teeth, laryngospasm, bronchospasm, desaturation below 90%) had been recorded.
26535|NCT02482870|E1|Reported Event|King Vision First, Then Macintosh|These patients had been intubated with a King Vision video laryngoscope first, and then with a Macintosh laryngoscope. Airway complications related to the laryngoscopy and intubation (cuts, bleeding, damage to the teeth, laryngospasm, bronchospasm, desaturation below 90%) had been recorded.
26536|NCT02482805|B4|Baseline|Total|Total of all reporting groups
26537|NCT02482805|B3|Baseline|Rest|"Individuals rest (no postures) for 2 minutes prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
26538|NCT02482805|B2|Baseline|Submissive Posing|"Individuals hold two, 1-minute postures associated with submissiveness and low power prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
26539|NCT02482805|B1|Baseline|Power Posing|"Individuals hold two, 1-minute postures associated with dominance and high power prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
26540|NCT02482805|P3|Participant Flow|Rest|"Individuals rest (no postures) for 2 minutes prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
26541|NCT02482805|P2|Participant Flow|Submissive Posing|"Individuals hold two, 1-minute postures associated with submissiveness and low power prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
26542|NCT02482805|P1|Participant Flow|Power Posing|"Individuals hold two, 1-minute postures associated with dominance and high power prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
26543|NCT02482805|O3|Outcome|Rest|"Individuals rest (no postures) for 2 minutes prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
26544|NCT02482805|O2|Outcome|Submissive Posing|"Individuals hold two, 1-minute postures associated with submissiveness and low power prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
26545|NCT02482805|O1|Outcome|Power Posing|"Individuals hold two, 1-minute postures associated with dominance and high power prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
26546|NCT02482805|O3|Outcome|Rest|"Individuals rest (no postures) for 2 minutes prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
26547|NCT02482805|O2|Outcome|Submissive Posing|"Individuals hold two, 1-minute postures associated with submissiveness and low power prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
26548|NCT02482805|O1|Outcome|Power Posing|"Individuals hold two, 1-minute postures associated with dominance and high power prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
26549|NCT02482805|O3|Outcome|Rest|"Individuals rest (no postures) for 2 minutes prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
26550|NCT02482805|O2|Outcome|Submissive Posing|"Individuals hold two, 1-minute postures associated with submissiveness and low power prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
26551|NCT02482805|O1|Outcome|Power Posing|"Individuals hold two, 1-minute postures associated with dominance and high power prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
26552|NCT02482805|E3|Reported Event|Rest|"Individuals rest (no postures) for 2 minutes prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
26553|NCT02482805|E2|Reported Event|Submissive Posing|"Individuals hold two, 1-minute postures associated with submissiveness and low power prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
26554|NCT02482805|E1|Reported Event|Power Posing|"Individuals hold two, 1-minute postures associated with dominance and high power prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
26578|NCT02482428|O4|Outcome|Vehicle to LCC|Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
26555|NCT02482571|B1|Baseline|Mild Hypoxia|During normoxia, the computer-controlled gas blender provides a gas mixture that generates pressures of expired O2 and CO2 similar to the resting values measured for each subject (32-35mmHg and 100-110 mmHg, respectively). During mild hypoxia, we will target the same expired CO2 of normoxia and a 60 mmHg reduction of expired O2 from the resting value (to a minimum limit of 50 mmHg), which is expected to reduce arterial oxygen saturation to 82-85%. In mild hypoxia, the fraction of inspired oxygen is reduced from ~21% (room air) to ~12% (equivalent to an altitude of 4000 meters). During both conditions of normoxia and mild hypoxia, the brain activity of subjects is monitored with functional magnetic resonance spectroscopy (fMRS) while they are presented with visual stimuli.
26556|NCT02482571|P1|Participant Flow|Mild Hypoxia|Mild Hypoxia: During normoxia, the computer-controlled gas blender provides a gas mixture that generates pressures of expired O2 and CO2 similar to the resting values measured for each subject (32-35mmHg and 100-110 mmHg, respectively). During mild hypoxia, we will target the same expired CO2 of normoxia and a 60 mmHg reduction of expired O2 from the resting value (to a minimum limit of 50 mmHg), which is expected to reduce arterial oxygen saturation to 82-85%. In mild hypoxia, the fraction of inspired oxygen is reduced from ~21% (room air) to ~12%. During both conditions of normoxia and mild hypoxia, the brain activity of subjects is monitored with functional MRI (fMRI) and functional MRS (fMRS) during visual stimuli.
26557|NCT02482571|O1|Outcome|Mild Hypoxia|Mild Hypoxia: During normoxia, the computer-controlled gas blender provides a gas mixture that generates pressures of expired O2 and CO2 similar to the resting values measured for each subject (32-35mmHg and 100-110 mmHg, respectively). During mild hypoxia, we will target the same expired CO2 of normoxia and a 60 mmHg reduction of expired O2 from the resting value (to a minimum limit of 50 mmHg), which is expected to reduce arterial oxygen saturation to 82-85%. In mild hypoxia, the fraction of inspired oxygen is reduced from ~21% (room air) to ~12% . During both conditions of normoxia and mild hypoxia, the brain activity of subjects is monitored with functional MRI (fMRI) and functional MRS (fMRS) during visual stimuli.
26558|NCT02482571|O1|Outcome|Mild Hypoxia|Mild Hypoxia: During normoxia, the computer-controlled gas blender provides a gas mixture that generates pressures of expired O2 and CO2 similar to the resting values measured for each subject (32-35mmHg and 100-110 mmHg, respectively). During mild hypoxia, we will target the same expired CO2 of normoxia and a 60 mmHg reduction of expired O2 from the resting value (to a minimum limit of 50 mmHg), which is expected to reduce arterial oxygen saturation to 82-85%. In mild hypoxia, the fraction of inspired oxygen is reduced from ~21% (room air) to ~12% . During both conditions of normoxia and mild hypoxia, the brain activity of subjects is monitored with functional MRI (fMRI) and functional MRS (fMRS) during visual stimuli.
26559|NCT02482571|O1|Outcome|Mild Hypoxia|Mild Hypoxia: During normoxia, the computer-controlled gas blender provides a gas mixture that generates pressures of expired O2 and CO2 similar to the resting values measured for each subject (32-35mmHg and 100-110 mmHg, respectively). During mild hypoxia, we will target the same expired CO2 of normoxia and a 60 mmHg reduction of expired O2 from the resting value (to a minimum limit of 50 mmHg), which is expected to reduce arterial oxygen saturation to 82-85%. In mild hypoxia, the fraction of inspired oxygen is reduced from ~21% (room air) to ~12%. During both conditions of normoxia and mild hypoxia, the brain activity of subjects is monitored with functional MRI (fMRI) and functional MRS (fMRS) during visual stimuli.
26560|NCT02482571|O1|Outcome|Mild Hypoxia|Mild Hypoxia: During normoxia, the computer-controlled gas blender provides a gas mixture that generates pressures of expired O2 and CO2 similar to the resting values measured for each subject (32-35mmHg and 100-110 mmHg, respectively). During mild hypoxia, we will target the same expired CO2 of normoxia and a 60 mmHg reduction of expired O2 from the resting value (to a minimum limit of 50 mmHg), which is expected to reduce arterial oxygen saturation to 82-85%. In mild hypoxia, the fraction of inspired oxygen is reduced from ~21% (room air) to ~12%. During both conditions of normoxia and mild hypoxia, the brain activity of subjects is monitored with functional MRI (fMRI) and functional MRS (fMRS) during visual stimuli.
26561|NCT02482571|E1|Reported Event|Mild Hypoxia|Mild Hypoxia: During normoxia, the computer-controlled gas blender provides a gas mixture that generates pressures of expired O2 and CO2 similar to the resting values measured for each subject (32-35mmHg and 100-110 mmHg, respectively). During mild hypoxia, we will target the same expired CO2 of normoxia and a 60 mmHg reduction of expired O2 from the resting value (to a minimum limit of 50 mmHg), which is expected to reduce arterial oxygen saturation to 82-85%. In mild hypoxia, the fraction of inspired oxygen is reduced from ~21% (room air) to ~12% (equivalent to an altitude of 4000 meters). During both conditions of normoxia and mild hypoxia, the brain activity of subjects is monitored with functional MRI (fMRI) and functional MRS (fMRS) during visual stimuli.
26562|NCT02482428|B6|Baseline|Total|Total of all reporting groups
26563|NCT02482428|B5|Baseline|Aldara|Aldara 5% cream 3 applications per week for a maximum of 16 weeks
26564|NCT02482428|B4|Baseline|Vehicle to LCC|Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
26565|NCT02482428|B3|Baseline|Vehicle to NMC|Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
26566|NCT02482428|B2|Baseline|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
26567|NCT02482428|B1|Baseline|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
26568|NCT02482428|P5|Participant Flow|Aldara|Aldara 5% cream 3 applications per week for a maximum of 16 weeks
26569|NCT02482428|P4|Participant Flow|Vehicle to LCC|Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
26570|NCT02482428|P3|Participant Flow|Vehicle to NMC|Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
26571|NCT02482428|P2|Participant Flow|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
26572|NCT02482428|P1|Participant Flow|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
26573|NCT02482428|O4|Outcome|Aldara|Aldara 5% cream 3 applications per week for a maximum of 16 weeks
26574|NCT02482428|O3|Outcome|Combined Vehicle|Vehicle to nanomedicinal cream (NMC) and Vehicle to liquid crystal cream (LCC) Twice daily applications
26575|NCT02482428|O2|Outcome|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
26576|NCT02482428|O1|Outcome|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
26579|NCT02482428|O3|Outcome|Vehicle to NMC|Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
26580|NCT02482428|O2|Outcome|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
26581|NCT02482428|O1|Outcome|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
26582|NCT02482428|O4|Outcome|Aldara|Aldara 5% cream 3 applications per week for a maximum of 16 weeks
26583|NCT02482428|O3|Outcome|Combined Vehicle|Vehicle to nanomedicinal cream (NMC) and Vehicle to liquid crystal cream (LCC) Twice daily applications
26584|NCT02482428|O2|Outcome|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
26585|NCT02482428|O1|Outcome|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
26586|NCT02482428|E5|Reported Event|Aldara|Aldara 5% cream 3 applications per week for a maximum of 16 weeks
26587|NCT02482428|E4|Reported Event|Vehicle to LCC|Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
26588|NCT02482428|E3|Reported Event|Vehicle to NMC|Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
26589|NCT02482428|E2|Reported Event|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
26590|NCT02482428|E1|Reported Event|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
26591|NCT02482298|B4|Baseline|Total|Total of all reporting groups
26592|NCT02482298|B3|Baseline|TICAGRELOR 45MG BID + PLACEBO 10MG BID|
26593|NCT02482298|B2|Baseline|TICAGRELOR 10MG BID + PLACEBO 45MG BID|Note that 1 patient in the Ticagrelor 10mg BID + Placebo 45mg BID group was excluded from the Safety analysis set because they had no post-dose assessments.
26594|NCT02482298|B1|Baseline|PLACEBO 10MG BID + PLACEBO 45MG BID|
26595|NCT02482298|P3|Participant Flow|TICAGRELOR 45MG BID + PLACEBO 10MG BID|
26596|NCT02482298|P2|Participant Flow|TICAGRELOR 10MG BID + PLACEBO 45MG BID|Note that 1 patient in the Ticagrelor 10mg BID + Placebo 45mg BID group was excluded from the Safety analysis set because they had no post-dose assessments.
26597|NCT02482298|P1|Participant Flow|PLACEBO 10MG BID + PLACEBO 45MG BID|
26598|NCT02482298|O3|Outcome|TICAGRELOR 45MG BID + PLACEBO 10MG BID|
26599|NCT02482298|O2|Outcome|TICAGRELOR 10MG BID + PLACEBO 45MG BID|Note that 1 patient in the Ticagrelor 10mg BID + Placebo 45mg BID group was excluded from the Safety analysis set because they had no post-dose assessments.
26600|NCT02482298|O1|Outcome|PLACEBO 10MG BID + PLACEBO 45MG BID|
26601|NCT02482298|O3|Outcome|TICAGRELOR 45MG BID + PLACEBO 10MG BID|
26602|NCT02482298|O2|Outcome|TICAGRELOR 10MG BID + PLACEBO 45MG BID|Note that 1 patient in the Ticagrelor 10mg BID + Placebo 45mg BID group was excluded from the Safety analysis set because they had no post-dose assessments.
26603|NCT02482298|O1|Outcome|PLACEBO 10MG BID + PLACEBO 45MG BID|
26604|NCT02482298|O3|Outcome|TICAGRELOR 45MG BID + PLACEBO 10MG BID|
26605|NCT02482298|O2|Outcome|TICAGRELOR 10MG BID + PLACEBO 45MG BID|Note that 1 patient in the Ticagrelor 10mg BID + Placebo 45mg BID group was excluded from the Safety analysis set because they had no post-dose assessments.
26606|NCT02482298|O1|Outcome|PLACEBO 10MG BID + PLACEBO 45MG BID|
26607|NCT02482298|O3|Outcome|TICAGRELOR 45MG BID + PLACEBO 10MG BID|
26608|NCT02482298|O2|Outcome|TICAGRELOR 10MG BID + PLACEBO 45MG BID|Note that 1 patient in the Ticagrelor 10mg BID + Placebo 45mg BID group was excluded from the Safety analysis set because they had no post-dose assessments.
26609|NCT02482298|O1|Outcome|PLACEBO 10MG BID + PLACEBO 45MG BID|
26610|NCT02482298|O3|Outcome|TICAGRELOR 45MG BID + PLACEBO 10MG BID|
26611|NCT02482298|O2|Outcome|TICAGRELOR 10MG BID + PLACEBO 45MG BID|Note that 1 patient in the Ticagrelor 10mg BID + Placebo 45mg BID group was excluded from the Safety analysis set because they had no post-dose assessments.
26612|NCT02482298|O1|Outcome|PLACEBO 10MG BID + PLACEBO 45MG BID|
26613|NCT02482298|E3|Reported Event|TICAGRELOR 45MG BID + PLACEBO 10MG BID|
26614|NCT02482298|E2|Reported Event|TICAGRELOR 10MG BID + PLACEBO 45MG BID|Note that 1 patient in the Ticagrelor 10mg BID + Placebo 45mg BID group was excluded from the Safety analysis set because they had no post-dose assessments.
26615|NCT02482298|E1|Reported Event|PLACEBO 10MG BID + PLACEBO 45MG BID|
26616|NCT02482129|B3|Baseline|Total|Total of all reporting groups
26617|NCT02482129|B2|Baseline|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
26618|NCT02482129|B1|Baseline|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
26619|NCT02482129|P2|Participant Flow|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
26620|NCT02482129|P1|Participant Flow|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
26621|NCT02482129|O2|Outcome|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
26622|NCT02482129|O1|Outcome|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
26623|NCT02482129|O1|Outcome|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
26624|NCT02482129|O2|Outcome|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
26625|NCT02482129|O1|Outcome|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
26959|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
26626|NCT02482129|O2|Outcome|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
26627|NCT02482129|O1|Outcome|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
26628|NCT02482129|O2|Outcome|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
26629|NCT02482129|O1|Outcome|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
26630|NCT02482129|O2|Outcome|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
26631|NCT02482129|O1|Outcome|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
26632|NCT02482129|O2|Outcome|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
26633|NCT02482129|O1|Outcome|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
26634|NCT02482129|O2|Outcome|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
26635|NCT02482129|O1|Outcome|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
26636|NCT02482129|O2|Outcome|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
26637|NCT02482129|O1|Outcome|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
26638|NCT02482129|O2|Outcome|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
26639|NCT02482129|O1|Outcome|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
26640|NCT02482129|O2|Outcome|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
26641|NCT02482129|O1|Outcome|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
26642|NCT02482129|E4|Reported Event|Posttreatment|All subjects from the conclusion of treatment until exit from the study
26643|NCT02482129|E3|Reported Event|Dexamethasone|All subjects exposed to Dexamethasone ophthalmic solution
26644|NCT02482129|E2|Reported Event|LME636|All subjects exposed to LME636 ophthalmic solution
26645|NCT02482129|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to initiation of study treatment
26646|NCT02481934|B1|Baseline|NKAE Cells Infusion + Chemotherapy|"Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).~NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive: two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.~Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.~Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles."
26647|NCT02481934|P1|Participant Flow|NKAE Cells Infusion + Chemotherapy|"Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).~NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.~Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.~Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles."
26648|NCT02481934|O1|Outcome|NKAE Cells Infusion + Chemotherapy|"Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).~NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.~Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.~Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles."
26649|NCT02481934|O1|Outcome|NKAE Cells Infusion + Chemotherapy|"Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).~NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.~Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.~Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles."
26650|NCT02481934|E1|Reported Event|NKAE Cells Infusion + Chemotherapy|"Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).~NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.~Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.~Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles."
26651|NCT02481219|B3|Baseline|Total|Total of all reporting groups
26652|NCT02481219|B2|Baseline|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
26703|NCT02481141|O4|Outcome|Placebo Through Week 2 Change From Baseline|"Study matching placebo administration will be as follows:~Beginning Week 0: 1 capsule twice per day for 2 weeks"
26653|NCT02481219|B1|Baseline|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-CONTROL~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
26654|NCT02481219|P2|Participant Flow|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
26655|NCT02481219|P1|Participant Flow|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of polyethylene glycol (PEG) on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-CONTROL~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
26656|NCT02481219|O2|Outcome|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
26657|NCT02481219|O1|Outcome|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Control~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
26658|NCT02481219|O2|Outcome|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
26659|NCT02481219|O1|Outcome|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Control~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
26660|NCT02481219|O2|Outcome|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
26661|NCT02481219|O1|Outcome|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure- Control~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
26662|NCT02481219|O2|Outcome|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure- Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
26663|NCT02481219|O1|Outcome|Bowel Preparation Regimen - Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Control~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
26664|NCT02481219|O2|Outcome|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
26665|NCT02481219|O1|Outcome|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Control~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
26666|NCT02481219|O2|Outcome|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
26704|NCT02481141|O3|Outcome|5-ALA-SFC Through Week 12 (100 mg 2x/Day) Change From Baseline|"Study product administration will be as follows:~Beginning Week 4: 1 capsule of 100mg 5-ALA-SFC twice per day for 8 weeks"
26960|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
26667|NCT02481219|O1|Outcome|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-CONTROL~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
26668|NCT02481219|E2|Reported Event|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
26669|NCT02481219|E1|Reported Event|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Control~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
26670|NCT02481141|B3|Baseline|Total|Total of all reporting groups
26671|NCT02481141|B2|Baseline|Placebo|"Study matching placebo administration will be as follows:~Beginning Week 0: 1 capsule twice per day for 2 weeks Beginning Week 2: 1 capsule twice per day for 2 weeks Beginning Week 4: 1 capsule twice per day for 8 weeks~Placebo"
26672|NCT02481141|B1|Baseline|5-ALA-SFC|"Study product administration will be as follows:~Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks Beginning Week 4: 1 capsule of 100mg 5-ALA-SFC twice per day for 8 weeks~5-ALA-SFC: Study product will be in the form of white-opaque capsules for oral administration, containing either 50, 75, or 100 mg of active 5-ALA – SFC"
26673|NCT02481141|P2|Participant Flow|Placebo|"Study matching placebo administration will be as follows:~Beginning Week 0: 1 capsule twice per day for 2 weeks Beginning Week 2: 1 capsule twice per day for 2 weeks Beginning Week 4: 1 capsule twice per day for 8 weeks~Placebo"
26674|NCT02481141|P1|Participant Flow|5-ALA-SFC|"Study product administration will be as follows:~Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks Beginning Week 4: 1 capsule of 100mg 5-ALA-SFC twice per day for 8 weeks~5-ALA-SFC: Study product will be in the form of white-opaque capsules for oral administration, containing either 50, 75, or 100 mg of active 5-ALA – SFC"
26675|NCT02481141|O4|Outcome|Placebo Through Week 12 Change From Baseline|Week 12: 1 placebo capsule twice per day
26676|NCT02481141|O3|Outcome|Placebo Through Week 6 Change From Baseline|Week 6: 1 placebo capsule twice per day
26677|NCT02481141|O2|Outcome|5-ALA-SFC Through Week 12 Change From Baseline|Week 12: 1 capsule of 100mg 5-ALA-SFC twice per day
26678|NCT02481141|O1|Outcome|5-ALA-SFC Through Week 6 Change From Baseline|Week 6: 1 capsule of 100mg 5-ALA-SFC twice per day
26679|NCT02481141|O4|Outcome|Placebo Through Week 12 Change From Baseline|Week 12: 1 placebo capsule twice per day
26680|NCT02481141|O3|Outcome|Placebo Through Week 6 Change From Baseline|Week 6: 1 placebo capsule twice per day
26681|NCT02481141|O2|Outcome|5-ALA-SFC Through Week 12 Change From Baseline|Week 12: 1 capsule of 100mg 5-ALA-SFC twice per day
26682|NCT02481141|O1|Outcome|5-ALA-SFC Through Week 6 Change From Baseline|Week 6: 1 capsule of 100mg 5-ALA-SFC twice per day
26683|NCT02481141|O4|Outcome|Placebo Through Week 12 Change From Baseline|Week 12: 1 placebo capsule twice per day
26684|NCT02481141|O3|Outcome|Placebo Through Week 6 Change From Baseline|Week 6: 1 placebo capsule twice per day
26685|NCT02481141|O2|Outcome|5-ALA-SFC Through Week 12 Change From Baseline|Week 12: 1 capsule of 100mg 5-ALA-SFC twice per day
26686|NCT02481141|O1|Outcome|5-ALA-SFC Through Week 6 Change From Baseline|Week 6: 1 capsule of 100mg 5-ALA-SFC twice per day
26687|NCT02481141|O4|Outcome|Placebo Through Week 12 Change From Baseline|Week 12: 1 placebo capsule twice per day
26688|NCT02481141|O3|Outcome|Placebo Through Week 6 Change From Baseline|Week 6: 1 placebo capsule twice per day
26689|NCT02481141|O2|Outcome|5-ALA-SFC Through Week 12 Change From Baseline|Week 12: 1 capsule of 100mg 5-ALA-SFC twice per day
26690|NCT02481141|O1|Outcome|5-ALA-SFC Through Week 6 Change From Baseline|Week 6: 1 capsule of 100mg 5-ALA-SFC twice per day
26691|NCT02481141|O6|Outcome|Placebo Through Week 12 Change From Baseline|"Study matching placebo administration will be as follows:~Beginning Week 4: 1 capsule twice per day for 8 weeks"
26692|NCT02481141|O5|Outcome|Placebo Through Week 4 Change From Baseline|"Study matching placebo administration will be as follows:~Beginning Week 2: 1 capsule twice per day for 2 weeks"
26693|NCT02481141|O4|Outcome|Placebo Through Week 2 Change From Baseline|"Study matching placebo administration will be as follows:~Beginning Week 0: 1 capsule twice per day for 2 weeks"
26694|NCT02481141|O3|Outcome|5-ALA-SFC Through 12 (100 mg 2x/Day) Change From Baseline|"Study product administration will be as follows:~Beginning Week 4: 1 capsule of 100mg 5-ALA-SFC twice per day for 8 weeks"
26695|NCT02481141|O2|Outcome|5-ALA-SFC Through 4 (75 mg 2x/Day) Change From Baseline|"Study product administration will be as follows:~Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks"
26696|NCT02481141|O1|Outcome|5-ALA-SFC Through Week 2 (50 mg 2x/Day) Change From Baseline|"Study product administration will be as follows:~Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks"
26697|NCT02481141|O4|Outcome|Placebo Through Week 12 Change From Baseline|Week 12: 1 placebo capsule twice per day
26698|NCT02481141|O3|Outcome|Placebo Through Week 6 Change From Baseline|Week 6: 1 placebo capsule twice per day
26699|NCT02481141|O2|Outcome|5-ALA-SFC Through Week 12 Change From Baseline|Week 12: 1 capsule of 100mg 5-ALA-SFC twice per day
26700|NCT02481141|O1|Outcome|5-ALA-SFC Through Week 6 Change From Baseline|Week 6: 1 capsule of 100mg 5-ALA-SFC twice per day
26701|NCT02481141|O6|Outcome|Placebo Through Week 12 Change From Baseline|"Study matching placebo administration will be as follows:~Beginning Week 4: 1 capsule twice per day for 8 weeks"
26702|NCT02481141|O5|Outcome|Placebo Through Week 4 Change From Baseline|"Study matching placebo administration will be as follows:~Beginning Week 2: 1 capsule twice per day for 2 weeks"
26705|NCT02481141|O2|Outcome|5-ALA-SFC Through Week 4 (75 mg 2x/Day) Change From Baseline|"Study product administration will be as follows:~Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks"
26706|NCT02481141|O1|Outcome|5-ALA-SFC Through Week 2 (50 mg 2x/Day) Change From Baseline|"Study product administration will be as follows:~Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks"
26707|NCT02481141|O6|Outcome|Placebo Through Week 12 Change From Baseline|"Study matching placebo administration will be as follows:~Beginning Week 4: 1 capsule twice per day for 8 weeks"
26708|NCT02481141|O5|Outcome|Placebo Through Week 4 Change From Baseline|"Study matching placebo administration will be as follows:~Beginning Week 2: 1 capsule twice per day for 2 weeks"
26709|NCT02481141|O4|Outcome|Placebo Through Week 2 Change From Baseline|"Study matching placebo administration will be as follows:~Beginning Week 0: 1 capsule twice per day for 2 weeks"
26710|NCT02481141|O3|Outcome|5-ALA-SFC Through Wk 12 (100 mg 2x/Day) Change From Baseline|"Study product administration will be as follows:~Beginning Week 4: 1 capsule of 100mg 5-ALA-SFC twice per day for 8 weeks"
26711|NCT02481141|O2|Outcome|5-ALA-SFC Through Week 4 (75 mg 2x/Day) Change From Baseline|"Study product administration will be as follows:~Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks"
26712|NCT02481141|O1|Outcome|5-ALA-SFC Through Week 2 (50 mg 2x/Day) Change From Baseline|"Study product administration will be as follows:~Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks"
26713|NCT02481141|O6|Outcome|Placebo Through Week 12|"Study matching placebo administration will be as follows:~Beginning Week 4: 1 capsule twice per day for 8 weeks"
26714|NCT02481141|O5|Outcome|Placebo Through Week 4|"Study matching placebo administration will be as follows:~Beginning Week 2: 1 capsule twice per day for 2 weeks"
26715|NCT02481141|O4|Outcome|Placebo Through Week 2|"Study matching placebo administration will be as follows:~Beginning Week 0: 1 capsule twice per day for 2 weeks"
26716|NCT02481141|O3|Outcome|5-ALA-SFC Through Week 12 (100 mg 2x/Day)|"Study product administration will be as follows:~Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks"
26717|NCT02481141|O2|Outcome|5-ALA-SFC Through Week 4 (75 mg 2x/Day)|"Study product administration will be as follows:~Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks"
26718|NCT02481141|O1|Outcome|5-ALA-SFC Through Week 2 (50 mg 2x/Day)|"Study product administration will be as follows:~Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks"
26719|NCT02481141|E6|Reported Event|Placebo Through Week 12|Beginning Week 4: 1 placebo capsule twice per day for 8 weeks
26720|NCT02481141|E5|Reported Event|Placebo Through Week 4|Beginning Week 2: 1 placebo capsule twice per day for 2 weeks
26721|NCT02481141|E4|Reported Event|Placebo Through Week 2|Beginning Week 0: 1 placebo capsule twice per day for 2 weeks
26722|NCT02481141|E3|Reported Event|5-ALA-SFC Through Week 12|Beginning Week 4: 1 capsule of 100mg 5-ALA-SFC twice per day for 8 weeks
26723|NCT02481141|E2|Reported Event|5-ALA-SFC Through Week 4|Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks
26724|NCT02481141|E1|Reported Event|5-ALA-SFC Through Week 2|Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks
26725|NCT02480712|B1|Baseline|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
26726|NCT02480712|P1|Participant Flow|SOF/VEL 12 Weeks|Sofosbuvir/velpatasvir (SOF/VEL; Epclusa®) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
26727|NCT02480712|O3|Outcome|SOF/VEL 12 Weeks (Non TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.
26728|NCT02480712|O2|Outcome|SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents).
26729|NCT02480712|O1|Outcome|SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data for participants who took boosted TDF-containing regimens (defined as regimens containing TDF and RTV or COBI-boosted PIs or other agents (eg, EVG/COBI)) are summarized in this group.
26730|NCT02480712|O3|Outcome|SOF/VEL 12 Weeks (Non TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.
26731|NCT02480712|O2|Outcome|SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents).
26732|NCT02480712|O1|Outcome|SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data for participants who took boosted TDF-containing regimens (defined as regimens containing TDF and ritonavir (RTV) or cobicistat (COBI)-boosted protease inhibitors (PIs) or other agents (eg, elvitegravir (EVG)/COBI)) are summarized in this group.
26733|NCT02480712|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
26734|NCT02480712|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
26735|NCT02480712|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
26736|NCT02480712|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
26737|NCT02480712|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
26738|NCT02480712|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
26739|NCT02480712|E3|Reported Event|SOF/VEL 12 Weeks (Non TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.
26740|NCT02480712|E2|Reported Event|SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents).
26741|NCT02480712|E1|Reported Event|SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data for participants who took boosted TDF-containing regimens (defined as regimens containing TDF and RTV or COBI-boosted PIs or other agents (eg, EVG/COBI)) are summarized in this group.
26742|NCT02480621|B3|Baseline|Total|Total of all reporting groups
26743|NCT02480621|B2|Baseline|Liposomal Bupivacaine With Bupivacaine|"Intra-operatively, patients receive a local injection of liposomal bupivacaine with bupivacaine around the affected ankle.~Liposomal Bupivacaine with Bupivacaine: Pain medications injected locally during surgery around affected ankle."
26744|NCT02480621|B1|Baseline|Control|Standard of care: Open Reduction Internal Fixation with no injection of pain medications around the affected ankle, but these control patients did receive a local intra-operative injection saline while under general anesthesia
26745|NCT02480621|P2|Participant Flow|Liposomal Bupivacaine With Bupivacaine|"Intra-operatively, patients receive a local injection of liposomal bupivacaine with bupivacaine around the affected ankle.~Liposomal Bupivacaine with Bupivacaine: Pain medications injected locally during surgery around affected ankle."
26746|NCT02480621|P1|Participant Flow|Control|Standard of care: Open Reduction Internal Fixation with no injection of pain medications around the affected ankle, but these control patients did receive a local intra-operative injection saline while under general anesthesia
26747|NCT02480621|O2|Outcome|Liposomal Bupivacaine With Bupivacaine|"Intra-operatively, patients receive a local injection of liposomal bupivacaine with bupivacaine around the affected ankle.~Liposomal Bupivacaine with Bupivacaine: Pain medications injected locally during surgery around affected ankle."
26748|NCT02480621|O1|Outcome|Control|Standard of care: Open Reduction Internal Fixation with no injection of pain medications around the affected ankle, but these control patients did receive a local intra-operative injection saline while under general anesthesia
26749|NCT02480621|E2|Reported Event|Liposomal Bupivacaine With Bupivacaine|"Intra-operatively, patients receive a local injection of liposomal bupivacaine with bupivacaine around the affected ankle.~Liposomal Bupivacaine with Bupivacaine: Pain medications injected locally during surgery around affected ankle."
26750|NCT02480621|E1|Reported Event|Control|Standard of care: Open Reduction Internal Fixation with no injection of pain medications around the affected ankle, but these control patients did receive a local intra-operative injection saline while under general anesthesia
26751|NCT02480582|B1|Baseline|Overall Sample|Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack.
26752|NCT02480582|P6|Participant Flow|No Food, Then Almond, Then Cheese Savouries|Participants first received no food. After a washout period of 5 days, they then received a mid-morning snack of almonds. Finally, after another washout period participants received a mid-morning snack of cheese savouries.
26753|NCT02480582|P5|Participant Flow|Almond, Then Cheese Savouries, Then No Food|Participants first received a mid-morning snack of almonds. After a washout period of 5 days, they then received a mid-morning snack of cheese savouries. Finally, after another washout period participants received no food.
26754|NCT02480582|P4|Participant Flow|Cheese Savouries, Then No Food, Then Almond|Participants first received a mid-morning snack of cheese savouries. After a washout period of 5 days, they then received no food. Finally, after another washout period participants received a mid-morning snack of almonds.
26755|NCT02480582|P3|Participant Flow|No Food, Then Cheese Savouries, Then Almond|Participants first received no food. After a washout period of 5 days, they then received a mid-morning snack of cheese savouries. Finally, after another washout period participants received a mid-morning snack of almonds.
26756|NCT02480582|P2|Participant Flow|Cheese Savouries Then Almond, Then No Food|Participants first received a mid-morning snack of cheese savouries. After a washout period of 5 days, they then received a mid-morning snack of almonds. Finally, after another washout period participants received no food.
26757|NCT02480582|P1|Participant Flow|Almond, Then No Food, Then Cheese Savouries|Participants first received a mid-morning snack of almonds. After a washout period of 5 days, they then received no food. Finally, after another washout period participants received a mid-morning snack of cheese savouries.
26758|NCT02480582|O3|Outcome|No Food|No food provided, just water
26759|NCT02480582|O2|Outcome|Cheese Savouries|"Sainsbury's savoury biscuits~Cheese Savouries"
26760|NCT02480582|O1|Outcome|Almonds|"Whole, raw almonds~Almonds"
26761|NCT02480582|O3|Outcome|No Food|No food provided, just water
26762|NCT02480582|O2|Outcome|Cheese Savouries|"Sainsbury's savoury biscuits~Cheese Savouries"
26770|NCT02480582|E6|Reported Event|No Food, Then Almond, Then Cheese Savouries|"Participants first received no food. After a washout period of 5 days, they then received a mid-morning snack of almonds. Finally, after another washout period participants received a mid-morning snack of cheese savouries.~Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack."
26771|NCT02480582|E5|Reported Event|Almond, Then Cheese Savouries, Then No Food|"Participants first received a mid-morning snack of almonds. After a washout period of 5 days, they then received a mid-morning snack of cheese savouries. Finally, after another washout period participants received no food.~Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack."
26772|NCT02480582|E4|Reported Event|Cheese Savouries, Then No Food, Then Almond|"Participants first received a mid-morning snack of cheese savouries. After a washout period of 5 days, they then received no food. Finally, after another washout period participants received a mid-morning snack of almonds.~Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack."
26773|NCT02480582|E3|Reported Event|No Food, Then Cheese Savouries, Then Almond|"Participants first received no food. After a washout period of 5 days, they then received a mid-morning snack of cheese savouries. Finally, after another washout period participants received a mid-morning snack of almonds.~Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack."
26774|NCT02480582|E2|Reported Event|Cheese Savouries Then Almond, Then No Food|"Participants first received a mid-morning snack of cheese savouries. After a washout period of 5 days, they then received a mid-morning snack of almonds. Finally, after another washout period participants received no food.~Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack."
26775|NCT02480582|E1|Reported Event|Almond, Then No Food, Then Cheese Savouries|"Participants first received a mid-morning snack of almonds. After a washout period of 5 days, they then received no food. Finally, after another washout period participants received a mid-morning snack of cheese savouries.~Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack."
26776|NCT02480439|B4|Baseline|Total|Total of all reporting groups
26777|NCT02480439|B3|Baseline|TAK-648 Sequence CAB|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, after a high fat meal, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 3.
26778|NCT02480439|B2|Baseline|TAK-648 Sequence BCA|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 3.
26779|NCT02480439|B1|Baseline|TAK-648 Sequence ABC|Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 3.
26780|NCT02480439|P3|Participant Flow|TAK-648 Sequence CAB|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, after a high fat meal, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 3.
26781|NCT02480439|P2|Participant Flow|TAK-648 Sequence BCA|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 3.
26782|NCT02480439|P1|Participant Flow|TAK-648 Sequence ABC|Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 3.
26783|NCT02480439|O3|Outcome|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
26784|NCT02480439|O2|Outcome|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
26785|NCT02480439|O1|Outcome|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
26786|NCT02480439|O3|Outcome|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
26787|NCT02480439|O2|Outcome|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
26788|NCT02480439|O1|Outcome|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
26789|NCT02480439|O3|Outcome|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
26790|NCT02480439|O2|Outcome|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
26791|NCT02480439|O1|Outcome|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
26792|NCT02480439|O3|Outcome|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
26793|NCT02480439|O2|Outcome|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
26794|NCT02480439|O1|Outcome|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
26795|NCT02480439|O3|Outcome|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
26796|NCT02480439|O2|Outcome|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
26797|NCT02480439|O1|Outcome|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
26798|NCT02480439|O3|Outcome|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
26799|NCT02480439|O2|Outcome|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
26800|NCT02480439|O1|Outcome|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
26801|NCT02480439|E3|Reported Event|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
26802|NCT02480439|E2|Reported Event|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
26803|NCT02480439|E1|Reported Event|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
26804|NCT02480166|B4|Baseline|Total|Total of all reporting groups
26805|NCT02480166|B3|Baseline|Extended Treatment to 12 Weeks SOF/LED|Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator’s preference
26806|NCT02480166|B2|Baseline|12 Weeks SOF/LED|"Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.~12 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers’ instructions, and can be taken with or without food."
26807|NCT02480166|B1|Baseline|8 Weeks SOF/LED|"Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.~8 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers’ instructions, and can be taken with or without food."
26808|NCT02480166|P3|Participant Flow|Extended Treatment to 12 Weeks SOF/LED|Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator’s preference
26809|NCT02480166|P2|Participant Flow|12 Weeks SOF/LED|"Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.~12 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers’ instructions, and can be taken with or without food."
26810|NCT02480166|P1|Participant Flow|8 Weeks SOF/LED|"Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.~8 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers’ instructions, and can be taken with or without food."
26811|NCT02480166|O3|Outcome|Extended Treatment to 12 Weeks SOF/LED|Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator’s preference
26812|NCT02480166|O2|Outcome|12 Weeks SOF/LED|"Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.~12 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers’ instructions, and can be taken with or without food."
26813|NCT02480166|O1|Outcome|8 Weeks SOF/LED|"Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.~8 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers’ instructions, and can be taken with or without food."
26814|NCT02480166|O3|Outcome|Treatment Extension to 12 Weeks SOF/LED|Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator’s preference
26815|NCT02480166|O2|Outcome|12 Weeks SOF/LED|"Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.~12 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers’ instructions, and can be taken with or without food."
26816|NCT02480166|O1|Outcome|8 Weeks SOF/LED|"Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.~8 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers’ instructions, and can be taken with or without food."
26817|NCT02480166|E3|Reported Event|Extended Treatment to 12 Weeks SOF/LED|Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator’s preference
26961|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
26818|NCT02480166|E2|Reported Event|12 Weeks SOF/LED|"Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.~12 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers’ instructions, and can be taken with or without food."
26819|NCT02480166|E1|Reported Event|8 Weeks SOF/LED|"Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.~8 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers’ instructions, and can be taken with or without food."
26820|NCT02480153|B3|Baseline|Total|Total of all reporting groups
26821|NCT02480153|B2|Baseline|Adalimumab-EU|Participants received subcutaneous (SC) injection of adalimumab (adalimumab sourced from the European Union) at a dose of 40 mg every other week.
26822|NCT02480153|B1|Baseline|PF-06410293|Participants received subcutaneous (SC) injection of PF-06410293 at a dose of 40 mg every other week.
26823|NCT02480153|P2|Participant Flow|Adalimumab-EU|Participants received subcutaneous (SC) injection of adalimumab (adalimumab sourced from the European Union) at a dose of 40 mg every other week.
26824|NCT02480153|P1|Participant Flow|PF-06410293|Participants received subcutaneous (SC) injection of PF-06410293 at a dose of 40 mg every other week.
26825|NCT02480153|O2|Outcome|Adalimumab-EU|Participants received subcutaneous (SC) injection of adalimumab (adalimumab sourced from the European Union) at a dose of 40 mg every other week.
26826|NCT02480153|O1|Outcome|PF-06410293|Participants received subcutaneous (SC) injection of PF-06410293 at a dose of 40 mg every other week.
26827|NCT02480153|E2|Reported Event|Adalimumab-EU|Participants received subcutaneous (SC) injection of adalimumab (adalimumab sourced from the European Union) at a dose of 40 mg every other week.
26828|NCT02480153|E1|Reported Event|PF-06410293|Participants received subcutaneous (SC) injection of PF-06410293 at a dose of 40 mg every other week.
26829|NCT02480010|B3|Baseline|Total|Total of all reporting groups
26830|NCT02480010|B2|Baseline|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
26831|NCT02480010|B1|Baseline|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
26832|NCT02480010|P2|Participant Flow|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
26833|NCT02480010|P1|Participant Flow|Pertuzumab 420 Milligrams (mg) - Cohort A|Participants in Cohort A received an intravenous (IV) loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
26834|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
26835|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
26836|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
26837|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
26838|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
26839|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
26840|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
26841|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
26842|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
26843|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
26844|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
26845|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
26962|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
26963|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
26846|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
26847|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
26848|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
26849|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
26850|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
26851|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
26852|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
26853|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
26854|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
26855|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
26856|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
26857|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
26858|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
26859|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
26860|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
26861|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
26862|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
26863|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
26864|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
26865|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
26866|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
26867|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
26868|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
26869|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
26870|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
26871|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
26872|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
26873|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
26874|NCT02480010|E2|Reported Event|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
26875|NCT02480010|E1|Reported Event|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
26876|NCT02479763|B3|Baseline|Total|Total of all reporting groups
26877|NCT02479763|B2|Baseline|Waveform-confirmed Loss-of-resistance|Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
26878|NCT02479763|B1|Baseline|Conventional Loss-of-resistance|Conventional loss-of-resistance: Using tactile feeling to identify thoracic epidural space
26879|NCT02479763|P2|Participant Flow|Waveform-confirmed Loss-of-resistance|Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
26880|NCT02479763|P1|Participant Flow|Conventional Loss-of-resistance|Conventional loss-of-resistance: Using tactile feeling to identify thoracic epidural space
26881|NCT02479763|O2|Outcome|Waveform-confirmed Loss-of-resistance|Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
26882|NCT02479763|O1|Outcome|Conventional Loss-of-resistance|
26883|NCT02479763|E2|Reported Event|Waveform-confirmed Loss-of-resistance|Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
26884|NCT02479763|E1|Reported Event|Conventional Loss-of-resistance|
26885|NCT02479412|B10|Baseline|Total|Total of all reporting groups
26886|NCT02479412|B9|Baseline|Sequence 9 (AZD7594 800 μg + AZD7594 250 μg + Placebo)|Participant received AZD7594 800 μg in Treatment Period 1 (1st intervention 14 days), AZD7594 250 μg in Treatment Period 2 (2nd intervention - 14 days) and Placebo in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
26887|NCT02479412|B8|Baseline|Sequence 8 (AZD7594 800 μg + Placebo + AZD7594 250 μg)|Participants received AZD7594 800 μg in Treatment Period 1 (1st intervention - 14 days), Placebo in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 250 μg Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
26888|NCT02479412|B7|Baseline|Sequence 7 (AZD7594 250 μg + AZD7594 58 μg + Placebo)|Participants received AZD7594 250 μg in Treatment Period 1 (1st intervention - 14 days), AZD7594 58 μg in Treatment Period 2 (2nd intervention - 14 days) and Placebo in Treatment Period 3 (3rd intervention- 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
26889|NCT02479412|B6|Baseline|Sequence 6 (AZD7594 250 μg + Placebo + AZD7594 58 μg)|Participants received AZD7594 250 μg in Treatment Period 1 (1st intervention - 14 days), Placebo in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 58 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
26890|NCT02479412|B5|Baseline|Sequence 5 (AZD7594 58 µg + AZD7594 800 µg + Placebo)|Participants received AZD7594 58 μg in Treatment Period 1 (1st intervention - 14 days), AZD7594 800 μg in Treatment Period 2 (2nd intervention - 14 days) and Placebo in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
26891|NCT02479412|B4|Baseline|Sequence 4 (AZD7594 58 μg + Placebo + AZD7594 800 μg)|Participants received AZD7594 58 μg in Treatment Period 1 (1st intervention - 14 days), Placebo in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 800 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
26892|NCT02479412|B3|Baseline|Sequence 3 (Placebo + AZD7594 800 µg + AZD7594 58 µg)|Participants received Placebo in Treatment Period 1 (1st intervention - 14 days), AZD7594 800 μg in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 58 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
26893|NCT02479412|B2|Baseline|Sequence 2 (Placebo + AZD7594 250 μg + AZD7594 800 μg)|Participants received Placebo in Treatment Period 1 (1st intervention – 14 days), AZD7594 250 μg in Treatment Period 2 (2nd intervention – 14 days) and AZD7594 800 μg in Treatment Period 3 (3rd intervention – 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
26894|NCT02479412|B1|Baseline|Sequence 1 (Placebo + AZD7594 58 μg + AZD7594 250 μg)|Participants received Placebo in Treatment Period 1 (1st intervention – 14 days), AZD7594 58 μg in Treatment Period 2 (2nd intervention – 14 days) and AZD7594 250 μg treatment in Period 3 (3rd intervention – 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
26895|NCT02479412|P9|Participant Flow|Sequence 9 (AZD7594 800 μg + AZD7594 250 μg + Placebo)|Participant received AZD7594 800 μg in Treatment Period 1 (1st intervention 14 days), AZD7594 250 μg in Treatment Period 2 (2nd intervention - 14 days) and Placebo in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
26896|NCT02479412|P8|Participant Flow|Sequence 8 (AZD7594 800 μg + Placebo + AZD7594 250 μg)|Participants received AZD7594 800 μg in Treatment Period 1 (1st intervention - 14 days), Placebo in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 250 μg Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
26897|NCT02479412|P7|Participant Flow|Sequence 7 (AZD7594 250 μg + AZD7594 58 μg + Placebo)|Participants received AZD7594 250 μg in Treatment Period 1 (1st intervention - 14 days), AZD7594 58 μg in Treatment Period 2 (2nd intervention - 14 days) and Placebo in Treatment Period 3 (3rd intervention- 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
26964|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
26965|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
26966|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily.
26967|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
26898|NCT02479412|P6|Participant Flow|Sequence 6 (AZD7594 250 μg + Placebo + AZD7594 58 μg)|Participants received AZD7594 250 μg in Treatment Period 1 (1st intervention - 14 days), Placebo in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 58 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
26899|NCT02479412|P5|Participant Flow|Sequence 5 (AZD7594 58 µg + AZD7594 800 µg + Placebo)|Participants received AZD7594 58 μg in Treatment Period 1 (1st intervention - 14 days), AZD7594 800 μg in Treatment Period 2 (2nd intervention - 14 days) and Placebo in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
26900|NCT02479412|P4|Participant Flow|Sequence 4 (AZD7594 58 μg + Placebo + AZD7594 800 μg)|Participants received AZD7594 58 μg in Treatment Period 1 (1st intervention - 14 days), Placebo in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 800 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
26901|NCT02479412|P3|Participant Flow|Sequence 3 (Placebo + AZD7594 800 µg + AZD7594 58 µg)|Participants received Placebo in Treatment Period 1 (1st intervention - 14 days), AZD7594 800 μg in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 58 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
26902|NCT02479412|P2|Participant Flow|Sequence 2 (Placebo + AZD7594 250 μg + AZD7594 800 μg)|Participants received Placebo in Treatment Period 1 (1st intervention – 14 days), AZD7594 250 μg in Treatment Period 2 (2nd intervention – 14 days) and AZD7594 800 μg in Treatment Period 3 (3rd intervention – 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
26903|NCT02479412|P1|Participant Flow|Sequence 1 (Placebo + AZD7594 58 μg + AZD7594 250 μg)|Participants received Placebo in Treatment Period 1 (1st intervention – 14 days), AZD7594 58 μg in Treatment Period 2 (2nd intervention – 14 days) and AZD7594 250 μg treatment in Period 3 (3rd intervention – 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
26904|NCT02479412|O3|Outcome|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
26905|NCT02479412|O2|Outcome|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
26906|NCT02479412|O1|Outcome|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
26907|NCT02479412|O3|Outcome|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
26908|NCT02479412|O2|Outcome|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
26909|NCT02479412|O1|Outcome|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
26910|NCT02479412|O3|Outcome|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
26911|NCT02479412|O2|Outcome|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
26912|NCT02479412|O1|Outcome|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
26913|NCT02479412|O3|Outcome|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
26914|NCT02479412|O2|Outcome|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
26915|NCT02479412|O1|Outcome|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
26916|NCT02479412|O3|Outcome|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
26917|NCT02479412|O2|Outcome|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
26918|NCT02479412|O1|Outcome|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
26919|NCT02479412|O3|Outcome|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
26920|NCT02479412|O2|Outcome|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
26921|NCT02479412|O1|Outcome|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
26922|NCT02479412|O3|Outcome|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
26923|NCT02479412|O2|Outcome|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
26924|NCT02479412|O1|Outcome|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
26925|NCT02479412|O3|Outcome|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
26926|NCT02479412|O2|Outcome|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
26927|NCT02479412|O1|Outcome|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
26928|NCT02479412|O3|Outcome|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
26929|NCT02479412|O2|Outcome|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
26930|NCT02479412|O1|Outcome|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
26931|NCT02479412|O3|Outcome|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
26932|NCT02479412|O2|Outcome|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
26933|NCT02479412|O1|Outcome|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
26934|NCT02479412|O3|Outcome|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
26935|NCT02479412|O2|Outcome|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
26936|NCT02479412|O1|Outcome|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
26937|NCT02479412|O4|Outcome|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
26938|NCT02479412|O3|Outcome|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
26939|NCT02479412|O2|Outcome|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
26940|NCT02479412|O1|Outcome|Placebo|Placebo for AZD7594 DPI once daily
26941|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
26942|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
26943|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
26944|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
26945|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
26946|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
26947|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
26948|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
26949|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
26950|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
26951|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
26969|NCT02479412|E4|Reported Event|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
26970|NCT02479412|E3|Reported Event|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
26971|NCT02479412|E2|Reported Event|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
26972|NCT02479412|E1|Reported Event|Placebo (PBO)|Placebo for AZD7594 DPI once daily
26973|NCT02479139|B7|Baseline|Total|Total of all reporting groups
26974|NCT02479139|B6|Baseline|ANT-1207 Dose 5|Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
26975|NCT02479139|B5|Baseline|ANT-1207 Dose 4|Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
26976|NCT02479139|B4|Baseline|ANT-1207 Dose 3|Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
26977|NCT02479139|B3|Baseline|ANT-1207 Dose 2|Botulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
26978|NCT02479139|B2|Baseline|ANT-1207 Dose 1|Botulinum toxin Type A topical liniment (ANT-1207) Dose 1 (lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
26979|NCT02479139|B1|Baseline|Vehicle|Vehicle for botulinum toxin Type A topical liniment (ANT-1207) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
26980|NCT02479139|P6|Participant Flow|ANT-1207 Dose 5|Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
26981|NCT02479139|P5|Participant Flow|ANT-1207 Dose 4|Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
26982|NCT02479139|P4|Participant Flow|ANT-1207 Dose 3|Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
26983|NCT02479139|P3|Participant Flow|ANT-1207 Dose 2|Botulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
26984|NCT02479139|P2|Participant Flow|ANT-1207 Dose 1|Botulinum toxin Type A topical liniment (ANT-1207) Dose 1 (lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
26985|NCT02479139|P1|Participant Flow|Vehicle|Vehicle for botulinum toxin Type A topical liniment (ANT-1207) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
26986|NCT02479139|O6|Outcome|ANT-1207 Dose 5|Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
26987|NCT02479139|O5|Outcome|ANT-1207 Dose 4|Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
26988|NCT02479139|O4|Outcome|ANT-1207 Dose 3|Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
26989|NCT02479139|O3|Outcome|ANT-1207 Dose 2|Botulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
26990|NCT02479139|O2|Outcome|ANT-1207 Dose 1|Botulinum toxin Type A topical liniment (ANT-1207) Dose 1 (lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
26991|NCT02479139|O1|Outcome|Vehicle|Vehicle for botulinum toxin Type A topical liniment (ANT-1207) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
26992|NCT02479139|O6|Outcome|ANT-1207 Dose 5|Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
26993|NCT02479139|O5|Outcome|ANT-1207 Dose 4|Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
26994|NCT02479139|O4|Outcome|ANT-1207 Dose 3|Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
26995|NCT02479139|O3|Outcome|ANT-1207 Dose 2|Botulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
26996|NCT02479139|O2|Outcome|ANT-1207 Dose 1|Botulinum toxin Type A topical liniment (ANT-1207) Dose 1 (lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
26997|NCT02479139|O1|Outcome|Vehicle|Vehicle for botulinum toxin Type A topical liniment (ANT-1207) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
26998|NCT02479139|O6|Outcome|ANT-1207 Dose 5|Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
26999|NCT02479139|O5|Outcome|ANT-1207 Dose 4|Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
27000|NCT02479139|O4|Outcome|ANT-1207 Dose 3|Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
27001|NCT02479139|O3|Outcome|ANT-1207 Dose 2|Botulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
27002|NCT02479139|O2|Outcome|ANT-1207 Dose 1|Botulinum toxin Type A topical liniment (ANT-1207) Dose 1 (lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
27003|NCT02479139|O1|Outcome|Vehicle|Vehicle for botulinum toxin Type A topical liniment (ANT-1207) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
27004|NCT02479139|E6|Reported Event|ANT-1207 Dose 5|Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
27005|NCT02479139|E5|Reported Event|ANT-1207 Dose 4|Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
27040|NCT02478580|O1|Outcome|Nuvigil|"A single oral dose of Nuvigil 150mg in preoperative area~NUVIGIL: Patient will receive Nuvigil before the surgery"
27006|NCT02479139|E4|Reported Event|ANT-1207 Dose 3|Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
27007|NCT02479139|E3|Reported Event|ANT-1207 Dose 2|Botulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
27008|NCT02479139|E2|Reported Event|ANT-1207 Dose 1|Botulinum toxin Type A topical liniment (ANT-1207) Dose 1 (lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
27009|NCT02479139|E1|Reported Event|Vehicle|Vehicle for botulinum toxin Type A topical liniment (ANT-1207) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
27010|NCT02478671|B1|Baseline|TR Band|MRI based Radial artery measurement
27011|NCT02478671|P1|Participant Flow|TR Band|MRI based radial artery measurement
27012|NCT02478671|O1|Outcome|TR Band|Pulse Oxymetry
27013|NCT02478671|O1|Outcome|TR Band|MRI based Radial artery measurement
27014|NCT02478671|E1|Reported Event|TR Band|MRI based radial artery measurement
27015|NCT02478632|B3|Baseline|Total|Total of all reporting groups
27016|NCT02478632|B2|Baseline|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (CAR). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study (study medication was administered in the parent study and not in study 202094).
27017|NCT02478632|B1|Baseline|DTG + RPV|Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
27018|NCT02478632|P2|Participant Flow|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (CAR). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study (study medication was administered in the parent study and not in study 202094).
27019|NCT02478632|P1|Participant Flow|DTG + RPV|Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
27020|NCT02478632|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (CAR). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study (study medication was administered in the parent study and not in study 202094).
27021|NCT02478632|O1|Outcome|DTG + RPV|Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
27022|NCT02478632|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (CAR). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study (study medication was administered in the parent study and not in study 202094).
27023|NCT02478632|O1|Outcome|DTG + RPV|Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
27024|NCT02478632|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (CAR). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study (study medication was administered in the parent study and not in study 202094).
27025|NCT02478632|O1|Outcome|DTG + RPV|Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
27026|NCT02478632|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (CAR). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study (study medication was administered in the parent study and not in study 202094).
27027|NCT02478632|O1|Outcome|DTG + RPV|Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
27028|NCT02478632|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (CAR). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study (study medication was administered in the parent study and not in study 202094).
27029|NCT02478632|O1|Outcome|DTG + RPV|Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
27030|NCT02478632|E2|Reported Event|Current Antiretroviral Regimen (CAR)|Participants continued to receive their current antiretroviral regimen. CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study (study medication was administered in the parent study and not in study 202094).
27031|NCT02478632|E1|Reported Event|DTG + RPV|Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
27032|NCT02478580|B3|Baseline|Total|Total of all reporting groups
27033|NCT02478580|B2|Baseline|Control|Placebo in preoperative area
27034|NCT02478580|B1|Baseline|Nuvigil|"A single oral dose of Nuvigil 150mg in preoperative area~NUVIGIL: Patient will receive Nuvigil before the surgery"
27035|NCT02478580|P2|Participant Flow|Control|"Placebo in preoperative area~Patient will receive placebo before the surgery"
27036|NCT02478580|P1|Participant Flow|Nuvigil|"A single oral dose of Nuvigil 150mg in preoperative area~NUVIGIL: Patient will receive Nuvigil before the surgery"
27037|NCT02478580|O2|Outcome|Placebo|"A single oral placebo will be given in preoperative area~Nuvigil: Patients will receive Nuvigil before the surgery"
27038|NCT02478580|O1|Outcome|Nuvigil|A single oral dose of Nuvigil at 150mg dose in preoperative area
27039|NCT02478580|O2|Outcome|Control|Placebo in preoperative area
27041|NCT02478580|E2|Reported Event|Control|"Placebo in preoperative area~Patient will receive placebo before the surgery"
27042|NCT02478580|E1|Reported Event|Nuvigil|"A single oral dose of Nuvigil 150 mg in preoperative area~NUVIGIL: Patient will receive Nuvigil before the surgery"
27043|NCT02478372|B3|Baseline|Total|Total of all reporting groups
27044|NCT02478372|B2|Baseline|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
27045|NCT02478372|B1|Baseline|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
27046|NCT02478372|P2|Participant Flow|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
27047|NCT02478372|P1|Participant Flow|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
27048|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
27049|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
27050|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
27051|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
27080|NCT02477605|B2|Baseline|23-Gauge|CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery
27081|NCT02477605|B1|Baseline|27-Gauge|CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery
27082|NCT02477605|P2|Participant Flow|23-Gauge|CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery
27083|NCT02477605|P1|Participant Flow|27-Gauge|CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery
27127|NCT02477020|O2|Outcome|TAK-063|TAK-063 20 mg, tablets, orally, once daily for up to 6 weeks.
27052|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
27053|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
27054|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
27055|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
27056|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
27057|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
27058|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
27059|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
27060|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
27084|NCT02477605|O2|Outcome|23-Gauge|CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery
27061|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
27062|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
27063|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
27064|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
27065|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
27066|NCT02478372|E2|Reported Event|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
27067|NCT02478372|E1|Reported Event|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
27068|NCT02478164|B1|Baseline|Ponatinib|Drug will be administered once daily per cycle through oral ingestion.
27069|NCT02478164|P1|Participant Flow|Ponatinib|Drug will be administered once daily per cycle through oral ingestion.
27070|NCT02478164|O1|Outcome|Ponatinib|Drug will be administered once daily per cycle through oral ingestion.
27071|NCT02478164|O1|Outcome|Ponatinib|Drug will be administered once daily per cycle through oral ingestion.
27072|NCT02478164|O1|Outcome|Ponatinib|Drug will be administered once daily per cycle through oral ingestion.
27073|NCT02478164|O1|Outcome|Ponatinib|Drug will be administered once daily per cycle through oral ingestion.
27074|NCT02478164|E1|Reported Event|Ponatinib|Drug will be administered once daily per cycle through oral ingestion.
27075|NCT02477709|B1|Baseline|Gefapixant|Gefapixant oral tablets (150 mg) administered as a single dose gefapixant: gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only
27076|NCT02477709|P1|Participant Flow|Gefapixant|Gefapixant oral tablets (150 mg) administered as a single dose gefapixant: gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only
27077|NCT02477709|O1|Outcome|Gefapixant|Gefapixant oral tablets (150 mg) administered as a single dose gefapixant: gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only
27078|NCT02477709|E1|Reported Event|Gefapixant|Gefapixant oral tablets (150 mg) administered as a single dose gefapixant: gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only
27079|NCT02477605|B3|Baseline|Total|Total of all reporting groups
36464|NCT02389088|O10|Outcome|Phase II - Week 6 - 24 Hours|
27085|NCT02477605|O1|Outcome|27-Gauge|CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery
27086|NCT02477605|O2|Outcome|23-Gauge|CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery
27087|NCT02477605|O1|Outcome|27-Gauge|CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery
27088|NCT02477605|O2|Outcome|23-Gauge|CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery
27089|NCT02477605|O1|Outcome|27-Gauge|CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery
27090|NCT02477605|E6|Reported Event|23-Gauge Systemic|Non-ocular adverse events
27091|NCT02477605|E5|Reported Event|23-Gauge Fellow Eye|Ocular events, untreated (fellow) eye
27092|NCT02477605|E4|Reported Event|23-Gauge Treated Eye|Ocular events, treated (study) eye
27093|NCT02477605|E3|Reported Event|27-Gauge Systemic|Non-ocular adverse events
27094|NCT02477605|E2|Reported Event|27-Gauge Fellow Eye|Ocular events, untreated (fellow) eye
27095|NCT02477605|E1|Reported Event|27-Gauge Treated Eye|Ocular events, treated (study) eye
27096|NCT02477527|B1|Baseline|Stribild|"Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.~elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day."
27097|NCT02477527|P1|Participant Flow|Study|"Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.~elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day."
27098|NCT02477527|O1|Outcome|Study|"Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.~elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day."
27099|NCT02477527|O1|Outcome|Study|"Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.~elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day."
27100|NCT02477527|O1|Outcome|Study|"Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.~elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day."
27101|NCT02477527|O1|Outcome|Study|"Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.~elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day."
27102|NCT02477527|O1|Outcome|Study|"Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.~elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day."
27103|NCT02477527|E1|Reported Event|Study|"Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.~elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day."
27104|NCT02477020|B3|Baseline|Total|Total of all reporting groups
27105|NCT02477020|B2|Baseline|TAK-063|TAK-063 20 mg, tablets, orally, once daily for up to 6 weeks.
27106|NCT02477020|B1|Baseline|Placebo|TAK-063 matching-placebo tablets, orally, once daily for up to 6 weeks.
27107|NCT02477020|P2|Participant Flow|TAK-063|TAK-063 20 mg, tablets, orally, once daily for up to 6 weeks.
27108|NCT02477020|P1|Participant Flow|Placebo|TAK-063 matching-placebo tablets, orally, once daily for up to 6 weeks.
27109|NCT02477020|O2|Outcome|TAK-063|TAK-063 20 mg, tablets, orally, once daily for up to 6 weeks.
27110|NCT02477020|O1|Outcome|Placebo|TAK-063 matching-placebo tablets, orally, once daily for up to 6 weeks.
27111|NCT02477020|O2|Outcome|TAK-063|TAK-063 20 mg, tablets, orally, once daily for up to 6 weeks.
27112|NCT02477020|O1|Outcome|Placebo|TAK-063 matching-placebo tablets, orally, once daily for up to 6 weeks.
27113|NCT02477020|O2|Outcome|TAK-063|TAK-063 20 mg, tablets, orally, once daily for up to 6 weeks.
27114|NCT02477020|O1|Outcome|Placebo|TAK-063 matching-placebo tablets, orally, once daily for up to 6 weeks.
27115|NCT02477020|O2|Outcome|TAK-063|TAK-063 20 mg, tablets, orally, once daily for up to 6 weeks.
27116|NCT02477020|O1|Outcome|Placebo|TAK-063 matching-placebo tablets, orally, once daily for up to 6 weeks.
27117|NCT02477020|O2|Outcome|TAK-063|TAK-063 20 mg, tablets, orally, once daily for up to 6 weeks.
27118|NCT02477020|O1|Outcome|Placebo|TAK-063 matching-placebo tablets, orally, once daily for up to 6 weeks.
27119|NCT02477020|O2|Outcome|TAK-063|TAK-063 20 mg, tablets, orally, once daily for up to 6 weeks.
27120|NCT02477020|O1|Outcome|Placebo|TAK-063 matching-placebo tablets, orally, once daily for up to 6 weeks.
27121|NCT02477020|O2|Outcome|TAK-063|TAK-063 20 mg, tablets, orally, once daily for up to 6 weeks.
27122|NCT02477020|O1|Outcome|Placebo|TAK-063 matching-placebo tablets, orally, once daily for up to 6 weeks.
27123|NCT02477020|O2|Outcome|TAK-063|TAK-063 20 mg, tablets, orally, once daily for up to 6 weeks.
27124|NCT02477020|O1|Outcome|Placebo|TAK-063 matching-placebo tablets, orally, once daily for up to 6 weeks.
27125|NCT02477020|O2|Outcome|TAK-063|TAK-063 20 mg, tablets, orally, once daily for up to 6 weeks.
27126|NCT02477020|O1|Outcome|Placebo|TAK-063 matching-placebo tablets, orally, once daily for up to 6 weeks.
36465|NCT02389088|O9|Outcome|Phase II - Week 6 - 0 Hours|
27128|NCT02477020|O1|Outcome|Placebo|TAK-063 matching-placebo tablets, orally, once daily for up to 6 weeks.
27129|NCT02477020|O2|Outcome|TAK-063|TAK-063 20 mg, tablets, orally, once daily for up to 6 weeks.
27130|NCT02477020|O1|Outcome|Placebo|TAK-063 matching-placebo tablets, orally, once daily for up to 6 weeks.
27131|NCT02477020|O2|Outcome|TAK-063|TAK-063 20 mg, tablets, orally, once daily for up to 6 weeks.
27132|NCT02477020|O1|Outcome|Placebo|TAK-063 matching-placebo tablets, orally, once daily for up to 6 weeks.
27133|NCT02477020|E2|Reported Event|TAK-063|TAK-063 20 mg, tablets, orally, once daily for up to 6 weeks.
27134|NCT02477020|E1|Reported Event|Placebo|TAK-063 matching-placebo tablets, orally, once daily for up to 6 weeks.
27135|NCT02476994|B3|Baseline|Total|Total of all reporting groups
27136|NCT02476994|B2|Baseline|Intralipid 20% (Lipid Injectable Emulsion, USP)|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"
27137|NCT02476994|B1|Baseline|Clinolipid (Lipid Injectable Emulsion, USP) 20%|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Clinolipid"
27138|NCT02476994|P2|Participant Flow|Intralipid 20% (Lipid Injectable Emulsion, USP)|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"
27139|NCT02476994|P1|Participant Flow|Clinolipid (Lipid Injectable Emulsion, USP) 20%|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Clinolipid"
27140|NCT02476994|O2|Outcome|Intralipid 20% (Lipid Injectable Emulsion, USP)|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"
27141|NCT02476994|O1|Outcome|Clinolipid (Lipid Injectable Emulsion, USP) 20%|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Clinolipid"
27142|NCT02476994|O2|Outcome|Intralipid 20% (Lipid Injectable Emulsion, USP)|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"
27143|NCT02476994|O1|Outcome|Clinolipid (Lipid Injectable Emulsion, USP) 20%|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Clinolipid"
27144|NCT02476994|O2|Outcome|Intralipid 20% (Lipid Injectable Emulsion, USP)|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"
27145|NCT02476994|O1|Outcome|Clinolipid (Lipid Injectable Emulsion, USP) 20%|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Clinolipid"
27146|NCT02476994|O2|Outcome|Intralipid 20% (Lipid Injectable Emulsion, USP)|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"
27147|NCT02476994|O1|Outcome|Clinolipid (Lipid Injectable Emulsion, USP) 20%|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Clinolipid"
27148|NCT02476994|O2|Outcome|Intralipid 20% (Lipid Injectable Emulsion, USP)|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"
27149|NCT02476994|O1|Outcome|Clinolipid (Lipid Injectable Emulsion, USP) 20%|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Clinolipid"
27150|NCT02476994|O2|Outcome|Intralipid 20% (Lipid Injectable Emulsion, USP)|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"
27151|NCT02476994|O1|Outcome|Clinolipid (Lipid Injectable Emulsion, USP) 20%|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Clinolipid"
27152|NCT02476994|O2|Outcome|Intralipid 20% (Lipid Injectable Emulsion, USP)|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"
27153|NCT02476994|O1|Outcome|Clinolipid (Lipid Injectable Emulsion, USP) 20%|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Clinolipid"
27154|NCT02476994|O2|Outcome|Intralipid 20% (Lipid Injectable Emulsion, USP)|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"
27155|NCT02476994|O1|Outcome|Clinolipid (Lipid Injectable Emulsion, USP) 20%|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Clinolipid"
27156|NCT02476994|O2|Outcome|Intralipid 20% (Lipid Injectable Emulsion, USP)|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"
27157|NCT02476994|O1|Outcome|Clinolipid (Lipid Injectable Emulsion, USP) 20%|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Clinolipid"
27158|NCT02476994|O2|Outcome|Intralipid 20% (Lipid Injectable Emulsion, USP)|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"
27159|NCT02476994|O1|Outcome|Clinolipid (Lipid Injectable Emulsion, USP) 20%|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Clinolipid"
27160|NCT02476994|O2|Outcome|Intralipid 20% (Lipid Injectable Emulsion, USP)|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"
27161|NCT02476994|O1|Outcome|Clinolipid (Lipid Injectable Emulsion, USP) 20%|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Clinolipid"
27162|NCT02476994|E2|Reported Event|Intralipid 20% (Lipid Injectable Emulsion, USP)|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion"
27163|NCT02476994|E1|Reported Event|Clinolipid (Lipid Injectable Emulsion, USP) 20%|"Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.~Clinolipid"
27164|NCT02476890|B5|Baseline|Total|Total of all reporting groups
27165|NCT02476890|B4|Baseline|Gefapixant 100 mg Then Placebo/Chronic Cough (Sequence B)|Chronic Cough participants in Sequence B were randomized to receive gefapixant 100 mg in treatment Period 1, then placebo in treatment Period 2.
27166|NCT02476890|B3|Baseline|Placebo Then Gefapixant 100 mg/Chronic Cough (Sequence A)|Chronic Cough Participants in Sequence A were randomized to receive placebo in treatment Period 1, then gefapixant 100 mg in treatment Period 2.
27167|NCT02476890|B2|Baseline|Gefapixant 100 mg Then Placebo/Healthy (Sequence B)|Healthy participants in Sequence B were randomized to receive gefapixant 100 mg in treatment Period 1, then placebo in treatment Period 2.
27168|NCT02476890|B1|Baseline|Placebo Then Gefapixant 100 mg/Healthy (Sequence A)|Healthy participants in Sequence A were randomized to receive placebo in treatment Period 1, then gefapixant 100 mg in treatment Period 2.
27169|NCT02476890|P4|Participant Flow|Gefapixant 100 mg Then Placebo/Chronic Cough (Sequence B)|Chronic Cough participants in Sequence B received a single dose of gefapixant 100 mg in treatment Period 1 then a single dose of placebo in treatment Period 2. There was a washout period of at least 48 hours between Period 1 and Period 2.
27170|NCT02476890|P3|Participant Flow|Placebo Then Gefapixant 100 mg/Chronic Cough (Sequence A)|Chronic Cough participants in Sequence A received a single dose of placebo in treatment Period 1 then a single dose of gefapixant 100 mg in treatment Period 2. There was a washout period of at least 48 hours between Period 1 and Period 2.
27171|NCT02476890|P2|Participant Flow|Gefapixant 100 mg Then Placebo/Healthy (Sequence B)|Healthy participants in Sequence B received a single dose of gefapixant 100 mg in treatment Period 1 then a single dose of placebo in treatment Period 2. There was a washout period of at least 48 hours between Period 1 and Period 2.
27172|NCT02476890|P1|Participant Flow|Placebo Then Gefapixant 100 mg/Healthy (Sequence A)|Healthy participants in Sequence A received a single dose of placebo in treatment Period 1 then a single dose of gefapixant 100 mg in treatment Period 2. There was a washout period of at least 48 hours between Period 1 and Period 2.
27173|NCT02476890|O4|Outcome|Placebo/Chronic Cough|Chronic Cough participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
27174|NCT02476890|O3|Outcome|Gefapixant 100 mg/Chronic Cough|Chronic Cough participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
27175|NCT02476890|O2|Outcome|Placebo/Healthy|Healthy participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
27176|NCT02476890|O1|Outcome|Gefapixant 100 mg/Healthy|Healthy participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
27177|NCT02476890|O4|Outcome|Placebo/Chronic Cough|Chronic Cough participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
27178|NCT02476890|O3|Outcome|Gefapixant 100 mg/Chronic Cough|Chronic Cough participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
27179|NCT02476890|O2|Outcome|Placebo/Healthy|Healthy participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
27180|NCT02476890|O1|Outcome|Gefapixant 100 mg/Healthy|Healthy participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
27181|NCT02476890|O2|Outcome|Placebo/Chronic Cough|Chronic Cough participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
27182|NCT02476890|O1|Outcome|Gefapixant 100 mg/Chronic Cough|Chronic Cough participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
27183|NCT02476890|O2|Outcome|Placebo/Chronic Cough|Chronic Cough participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
27184|NCT02476890|O1|Outcome|Gefapixant 100 mg/Chronic Cough|Chronic Cough participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
27185|NCT02476890|O2|Outcome|Placebo/Chronic Cough|Chronic Cough participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
27186|NCT02476890|O1|Outcome|Gefapixant 100 mg/Chronic Cough|Chronic Cough participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
27187|NCT02476890|O4|Outcome|Placebo/Chronic Cough|Chronic Cough participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
27188|NCT02476890|O3|Outcome|Gefapixant 100 mg/Chronic Cough|Chronic Cough participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
27189|NCT02476890|O2|Outcome|Placebo/Healthy|Healthy participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
27190|NCT02476890|O1|Outcome|Gefapixant 100 mg/Healthy|Healthy participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
27191|NCT02476890|O4|Outcome|Placebo/Chronic Cough|Chronic Cough participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
27192|NCT02476890|O3|Outcome|Gefapixant 100 mg/Chronic Cough|Chronic Cough participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
27193|NCT02476890|O2|Outcome|Placebo/Healthy|Healthy participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
27194|NCT02476890|O1|Outcome|Gefapixant 100 mg/Healthy|Healthy participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
27546|NCT02473471|O1|Outcome|MOP Side|The Micro-osteoperforation side (The Intervention side)
27195|NCT02476890|O4|Outcome|Placebo/Chronic Cough|Chronic Cough participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
27196|NCT02476890|O3|Outcome|Gefapixant 100 mg/Chronic Cough|Chronic Cough participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
27197|NCT02476890|O2|Outcome|Placebo/Healthy|Healthy participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
27198|NCT02476890|O1|Outcome|Gefapixant 100 mg/Healthy|Healthy participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
27199|NCT02476890|O4|Outcome|Placebo/Chronic Cough|Chronic Cough participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
27200|NCT02476890|O3|Outcome|Gefapixant 100 mg/Chronic Cough|Chronic Cough participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
27201|NCT02476890|O2|Outcome|Placebo/Healthy|Healthy participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
27202|NCT02476890|O1|Outcome|Gefapixant 100 mg/Healthy|Healthy participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
27203|NCT02476890|E4|Reported Event|Placebo/Chronic Cough|Chronic Cough participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
27204|NCT02476890|E3|Reported Event|Gefapixant 100 mg/Chronic Cough|Chronic Cough participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
27205|NCT02476890|E2|Reported Event|Placebo/Healthy|Healthy participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
27206|NCT02476890|E1|Reported Event|Gefapixant 100 mg/Healthy|Healthy participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
27207|NCT02476617|B1|Baseline|Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBV|Ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg QD) + dasabuvir (250 mg BID) + weight based Ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided BID)
27208|NCT02476617|P1|Participant Flow|Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBV|Ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily [QD]) + dasabuvir (250 mg twice daily [BID]) + weight based Ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided BID)
27209|NCT02476617|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBV|Ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg QD) + dasabuvir (250 mg BID) + weight based Ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided BID)
27210|NCT02476617|E1|Reported Event|Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBV|Arm/Group Description: Ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg QD) + dasabuvir (250 mg BID) + weight based Ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided BID)
27211|NCT02476565|B3|Baseline|Total|Total of all reporting groups
27212|NCT02476565|B2|Baseline|I-gel Supraglottic Device|"The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.~I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
27213|NCT02476565|B1|Baseline|LMA-Supreme Supraglottic Device|"The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff~LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
27214|NCT02476565|P2|Participant Flow|LMA-Supreme Supraglottic Device|"The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff~LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
27215|NCT02476565|P1|Participant Flow|I-gel Supraglottic Device|"The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.~I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
27216|NCT02476565|O2|Outcome|LMA-Supreme Supraglottic Device|"The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff~LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
27217|NCT02476565|O1|Outcome|I-gel Supraglottic Device|"The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.~I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
27362|NCT02474901|O1|Outcome|QLAIV, HIV-infected|"QLAIV administered to HIV-infected individuals 2 to 25 yoa~Quadrivalent Live Attenuated Influenza Vaccine"
27218|NCT02476565|O2|Outcome|LMA-Supreme Supraglottic Device|"The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff~LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
27219|NCT02476565|O1|Outcome|I-gel Supraglottic Device|"The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.~I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
27220|NCT02476565|O2|Outcome|LMA-Supreme Supraglottic Device|"The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff~LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
27221|NCT02476565|O1|Outcome|I-gel Supraglottic Device|"The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.~I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
27222|NCT02476565|O2|Outcome|LMA-Supreme Supraglottic Device|"The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff~LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
27223|NCT02476565|O1|Outcome|I-gel Supraglottic Device|"The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.~I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
27224|NCT02476565|O2|Outcome|LMA-Supreme Supraglottic Device|"The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff~LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
27225|NCT02476565|O1|Outcome|I-gel Supraglottic Device|"The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.~I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
27226|NCT02476565|O2|Outcome|LMA-Supreme Supraglottic Device|"The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff~LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
27227|NCT02476565|O1|Outcome|I-gel Supraglottic Device|"The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.~I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
27228|NCT02476565|O2|Outcome|LMA-Supreme Supraglottic Device|"The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff~LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
27229|NCT02476565|O1|Outcome|I-gel Supraglottic Device|"The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.~I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
27230|NCT02476565|O2|Outcome|LMA-Supreme Supraglottic Device|"The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff~LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
27363|NCT02474901|O2|Outcome|QLAIV, HIV-uninfected|"QLAIV administered to HIV-uninfected individuals 2 to 25 yoa~Quadrivalent Live Attenuated Influenza Vaccine"
27231|NCT02476565|O1|Outcome|I-gel Supraglottic Device|"The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.~I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
27232|NCT02476565|E2|Reported Event|LMA-Supreme Supraglottic Device|"The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff~LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
27233|NCT02476565|E1|Reported Event|I-gel Supraglottic Device|"The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.~I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway."
27234|NCT02476422|B3|Baseline|Total|Total of all reporting groups
27235|NCT02476422|B2|Baseline|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
27236|NCT02476422|B1|Baseline|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
27237|NCT02476422|P2|Participant Flow|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
27238|NCT02476422|P1|Participant Flow|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
27239|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
27240|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
27241|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
27242|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
27243|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
27244|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
27245|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
27246|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
27247|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
27248|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
27249|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
27547|NCT02473471|O2|Outcome|Control Side|Non intervention side
27250|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
27251|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
27252|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
27253|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
27254|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
27255|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
27256|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
27257|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
27258|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
27259|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
27260|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
27261|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
27262|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
27263|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
27264|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
27265|NCT02476422|E2|Reported Event|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
27266|NCT02476422|E1|Reported Event|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
27267|NCT02476175|B1|Baseline|Add-on Mirabegron|"Experimental: Add-on Mirabegron Patients without symptom improvement or with partial response under intensive behavioural protocol and medical therapy (at least 2 different antimuscarinic agents) will be recruited. They will keep the antimuscarinic and Mirabegron will be added (dual therapy).~Mirabegron: Patients will keep the antimuscarinic providing some efficacy and that is tolerated and Mirabegron will be added (dual therapy)."
27268|NCT02476175|P1|Participant Flow|Add-on Mirabegron|"Experimental: Add-on Mirabegron Patients without symptom improvement or with partial response under intensive behavioural protocol and medical therapy (at least 2 different antimuscarinic agents) will be recruited. They will keep the antimuscarinic and Mirabegron will be added (dual therapy).~Mirabegron: Patients will keep the antimuscarinic providing some efficacy and that is tolerated and Mirabegron will be added (dual therapy)."
27364|NCT02474901|O1|Outcome|QLAIV, HIV-infected|"QLAIV administered to HIV-infected individuals 2 to 25 yoa~Quadrivalent Live Attenuated Influenza Vaccine"
27269|NCT02476175|O1|Outcome|Add-on Mirabegron|"Experimental: Add-on Mirabegron Patients without symptom improvement or with partial response under intensive behavioural protocol and medical therapy (at least 2 different antimuscarinic agents) will be recruited. They will keep the antimuscarinic and Mirabegron will be added (dual therapy).~Mirabegron: Patients will keep the antimuscarinic providing some efficacy and that is tolerated and Mirabegron will be added (dual therapy)."
27270|NCT02476175|O1|Outcome|Add-on Mirabegron|"Experimental: Add-on Mirabegron Patients without symptom improvement or with partial response under intensive behavioural protocol and medical therapy (at least 2 different antimuscarinic agents) will be recruited. They will keep the antimuscarinic and Mirabegron will be added (dual therapy).~Mirabegron: Patients will keep the antimuscarinic providing some efficacy and that is tolerated and Mirabegron will be added (dual therapy)."
27271|NCT02476175|O1|Outcome|Add-on Mirabegron|"Experimental: Add-on Mirabegron Patients without symptom improvement or with partial response under intensive behavioural protocol and medical therapy (at least 2 different antimuscarinic agents) will be recruited. They will keep the antimuscarinic and Mirabegron will be added (dual therapy).~Mirabegron: Patients will keep the antimuscarinic providing some efficacy and that is tolerated and Mirabegron will be added (dual therapy)."
27272|NCT02476175|O1|Outcome|Add-on Mirabegron|"Experimental: Add-on Mirabegron Patients without symptom improvement or with partial response under intensive behavioural protocol and medical therapy (at least 2 different antimuscarinic agents) will be recruited. They will keep the antimuscarinic and Mirabegron will be added (dual therapy).~Mirabegron: Patients will keep the antimuscarinic providing some efficacy and that is tolerated and Mirabegron will be added (dual therapy)."
27273|NCT02476175|O1|Outcome|Add-on Mirabegron|"Experimental: Add-on Mirabegron Patients without symptom improvement or with partial response under intensive behavioural protocol and medical therapy (at least 2 different antimuscarinic agents) will be recruited. They will keep the antimuscarinic and Mirabegron will be added (dual therapy).~Mirabegron: Patients will keep the antimuscarinic providing some efficacy and that is tolerated and Mirabegron will be added (dual therapy)."
27274|NCT02476175|E1|Reported Event|Add-on Mirabegron|"Experimental: Add-on Mirabegron Patients without symptom improvement or with partial response under intensive behavioural protocol and medical therapy (at least 2 different antimuscarinic agents) will be recruited. They will keep the antimuscarinic and Mirabegron will be added (dual therapy).~Mirabegron: Patients will keep the antimuscarinic providing some efficacy and that is tolerated and Mirabegron will be added (dual therapy)."
27275|NCT02476032|B4|Baseline|Total|Total of all reporting groups
27276|NCT02476032|B3|Baseline|Prof Applied Placebo|"Subjects will be randomized to either receive the Prof applied placebo Crest Sensi-Stop strip (Procter & Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The placebo strip is blank (sham). The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.~Prof applied placebo: Crest Sensi-Stop strips (Procter & Gamble™) without the active ingredient will be placed on the qualifying teeth by a dental professional."
27277|NCT02476032|B2|Baseline|Self-applied Oxalate|"Participants randomized to the Active Comparator Group will have the following intervention: Intervention: self-applied oxalate (Crest Sensi-Stop strip Procter & Gamble™), which contains 3% dipotassium oxalate desensitizing gel. The strip will be placed by the participant, following the manufacturer's directions. The strip will be left in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.~Self applied oxalate: Subjects will apply the strips (Procter & Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions."
27278|NCT02476032|B1|Baseline|Prof Applied Oxalate|"Subjects will be randomized to either receive the Prof applied oxalate Crest Sensi-Stop strip (Procter & Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The placebo strip is blank. The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.~Prof applied oxalate: Crest Sensi-Stop strips (Procter & Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional."
27279|NCT02476032|P3|Participant Flow|Prof Applied Placebo|Subjects will be randomized to receive the Prof applied placebo Crest Sensi-Stop strip (Procter & Gamble™). The placebo strip is blank (sham). The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.
27280|NCT02476032|P2|Participant Flow|Self-applied Oxalate|"Participants randomized to the Active Comparator Group will have the following intervention: Intervention is the self-applied Crest Sensi-Stop strip (Procter & Gamble™), which contains 3% dipotassium oxalate desensitizing gel. The strip will be placed by the participant, following the manufacturer's directions. The strip will be left in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.~Self applied Crest Sensi-Stop strips (Procter & Gamble™): Subjects will apply the strips (Procter & Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions."
27281|NCT02476032|P1|Participant Flow|Prof Applied Oxalate|"Subjects will be randomized to receive the Prof applied oxalate Crest Sensi-Stop strip (Procter & Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.~Professionally applied Crest Sensi-Stop strips (Procter & Gamble™): Crest Sensi-Stop strips (Procter & Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional."
27282|NCT02476032|O3|Outcome|Prof Applied Placebo|"Subjects will be randomized to either receive the Prof applied placebo Crest Sensi-Stop strip (Procter & Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The placebo strip is blank (sham). The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.~Prof applied placebo: Crest Sensi-Stop strips (Procter & Gamble™) without the active ingredient will be placed on the qualifying teeth by a dental professional."
36466|NCT02389088|O8|Outcome|Phase II - Week 5 - 24 Hours|
27283|NCT02476032|O2|Outcome|Self-applied Oxalate|"Participants randomized to the Active Comparator Group will have the following intervention: Intervention: self-applied oxalate (Crest Sensi-Stop strip Procter & Gamble™), which contains 3% dipotassium oxalate desensitizing gel. The strip will be placed by the participant, following the manufacturer's directions. The strip will be left in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.~Self applied oxalate: Subjects will apply the strips (Procter & Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions."
27284|NCT02476032|O1|Outcome|Prof Applied Oxalate|"Subjects will be randomized to either receive the Prof applied oxalate Crest Sensi-Stop strip (Procter & Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The placebo strip is blank. The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.~Prof applied oxalate: Crest Sensi-Stop strips (Procter & Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional."
27285|NCT02476032|O3|Outcome|Prof Applied Placebo|Subjects will be randomized to receive the Prof applied placebo Crest Sensi-Stop strip (Procter & Gamble™). The placebo strip is blank (sham). The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.
27286|NCT02476032|O2|Outcome|Self-applied Oxalate|"Participants randomized to the Active Comparator Group will have the following intervention: Intervention is the self-applied Crest Sensi-Stop strip (Procter & Gamble™), which contains 3% dipotassium oxalate desensitizing gel. The strip will be placed by the participant, following the manufacturer's directions. The strip will be left in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.~Self applied Crest Sensi-Stop strips (Procter & Gamble™): Subjects will apply the strips (Procter & Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions."
27287|NCT02476032|O1|Outcome|Prof Applied Oxalate|"Subjects will be randomized to receive the Prof applied oxalate Crest Sensi-Stop strip (Procter & Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.~Professionally applied Crest Sensi-Stop strips (Procter & Gamble™): Crest Sensi-Stop strips (Procter & Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional."
27288|NCT02476032|E3|Reported Event|Prof Applied Placebo|"Subjects will be randomized to either receive the Prof applied placebo Crest Sensi-Stop strip (Procter & Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The placebo strip is blank (sham). The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.~Prof applied placebo: Crest Sensi-Stop strips (Procter & Gamble™) without the active ingredient will be placed on the qualifying teeth by a dental professional."
27289|NCT02476032|E2|Reported Event|Self-applied Oxalate|"Participants randomized to the Active Comparator Group will have the following intervention: Intervention: self-applied oxalate (Crest Sensi-Stop strip Procter & Gamble™), which contains 3% dipotassium oxalate desensitizing gel. The strip will be placed by the participant, following the manufacturer's directions. The strip will be left in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.~Self applied oxalate: Subjects will apply the strips (Procter & Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions."
27290|NCT02476032|E1|Reported Event|Prof Applied Oxalate|"Subjects will be randomized to either receive the Prof applied oxalate Crest Sensi-Stop strip (Procter & Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The placebo strip is blank. The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.~Prof applied oxalate: Crest Sensi-Stop strips (Procter & Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional."
27291|NCT02475980|B1|Baseline|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
27292|NCT02475980|P1|Participant Flow|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
27293|NCT02475980|O1|Outcome|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
27294|NCT02475980|O1|Outcome|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
27322|NCT02475395|O2|Outcome|Tester Only Subjects|"Male or female subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen~TRAK device: Use of TRAK to attain sperm concentration measurement"
27295|NCT02475980|O1|Outcome|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
27296|NCT02475980|O1|Outcome|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
27297|NCT02475980|O1|Outcome|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
27298|NCT02475980|O1|Outcome|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
27299|NCT02475980|E1|Reported Event|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
27300|NCT02475564|B3|Baseline|Total|Total of all reporting groups
27301|NCT02475564|B2|Baseline|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)~Placebo: 40mg of starch"
27302|NCT02475564|B1|Baseline|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol~Resveratrol: 40mg of resveratrol (powder)"
27303|NCT02475564|P2|Participant Flow|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol~Resveratrol: 40mg of resveratrol (powder)"
27304|NCT02475564|P1|Participant Flow|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)~Placebo: 40mg of starch"
27305|NCT02475564|O2|Outcome|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)~Placebo: 40mg of starch"
27306|NCT02475564|O1|Outcome|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol~Resveratrol: 40mg of resveratrol (powder)"
27307|NCT02475564|O2|Outcome|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)~Placebo: 40mg of starch"
27308|NCT02475564|O1|Outcome|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol~Resveratrol: 40mg of resveratrol (powder)"
27309|NCT02475564|O2|Outcome|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)~Placebo: 40mg of starch"
27310|NCT02475564|O1|Outcome|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol~Resveratrol: 40mg of resveratrol (powder)"
27311|NCT02475564|E2|Reported Event|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol~Resveratrol: 40mg of resveratrol (powder)"
27312|NCT02475564|E1|Reported Event|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)~Placebo: 40mg of starch"
27313|NCT02475395|B3|Baseline|Total|Total of all reporting groups
27314|NCT02475395|B2|Baseline|Tester Only Subjects|"Male or female subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen~TRAK device: Use of TRAK to attain sperm concentration measurement"
27315|NCT02475395|B1|Baseline|Donor/Tester Subjects|"Male subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen~TRAK device: Use of TRAK to attain sperm concentration measurement"
27316|NCT02475395|P2|Participant Flow|Tester Only Subjects|"Male or female subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen~TRAK device: Use of TRAK to attain sperm concentration measurement"
27317|NCT02475395|P1|Participant Flow|Donor/Tester Subjects|"Male subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen~TRAK device: Use of TRAK to attain sperm concentration measurement"
27318|NCT02475395|O2|Outcome|Tester Only Subjects|"Male or female subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen~TRAK device: Use of TRAK to attain sperm concentration measurement"
27319|NCT02475395|O1|Outcome|Donor/Tester Subjects|"Male subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen~TRAK device: Use of TRAK to attain sperm concentration measurement"
27320|NCT02475395|O2|Outcome|Tester Only Subjects|"Male or female subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen~TRAK device: Use of TRAK to attain sperm concentration measurement"
27321|NCT02475395|O1|Outcome|Donor/Tester Subjects|"Male subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen~TRAK device: Use of TRAK to attain sperm concentration measurement"
27323|NCT02475395|O1|Outcome|Donor/Tester Subjects|"Male subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen~TRAK device: Use of TRAK to attain sperm concentration measurement"
27324|NCT02475395|E2|Reported Event|Tester Only Subjects|"Male or female subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen~TRAK device: Use of TRAK to attain sperm concentration measurement"
27325|NCT02475395|E1|Reported Event|Donor/Tester Subjects|"Male subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen~TRAK device: Use of TRAK to attain sperm concentration measurement"
27326|NCT02475278|B1|Baseline|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
27327|NCT02475278|P1|Participant Flow|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
27328|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
27329|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
27330|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
27331|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
27332|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
27333|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
27334|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
27335|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
27336|NCT02475278|E1|Reported Event|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
27337|NCT02475031|B3|Baseline|Total|Total of all reporting groups
27338|NCT02475031|B2|Baseline|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
27339|NCT02475031|B1|Baseline|Placebo Group (TAP-S)|"(TAP-S) – the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
27340|NCT02475031|P2|Participant Flow|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
27341|NCT02475031|P1|Participant Flow|Placebo Group (TAP-S)|"(TAP-S) – the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
27342|NCT02475031|O2|Outcome|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
27360|NCT02474901|O1|Outcome|QLAIV, HIV-infected|"QLAIV administered to HIV-infected individuals 2 to 25 yoa~Quadrivalent Live Attenuated Influenza Vaccine"
27361|NCT02474901|O2|Outcome|QLAIV, HIV-uninfected|"QLAIV administered to HIV-uninfected individuals 2 to 25 yoa~Quadrivalent Live Attenuated Influenza Vaccine"
27548|NCT02473471|O1|Outcome|MOP Side|The Micro-osteoperforation side (The Intervention side)
27343|NCT02475031|O1|Outcome|Placebo Group (TAP-S)|"(TAP-S) – the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
27344|NCT02475031|O2|Outcome|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
27345|NCT02475031|O1|Outcome|Placebo Group (TAP-S)|"(TAP-S) – the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
27346|NCT02475031|O2|Outcome|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
27347|NCT02475031|O1|Outcome|Placebo Group (TAP-S)|"(TAP-S) – the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
27348|NCT02475031|O2|Outcome|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP-C: TAP catheters with ropivacaine infusion are inserted into the TAP area after a single shot TAP block. Single shot TAP block is performed using 30ml 0.5% ropivacaine at the end of the case."
27349|NCT02475031|O1|Outcome|Placebo Group (TAP-S)|"(TAP-S) – the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP-S: Catheters with saline infusion are inserted into the TAP area after a single shot TAP block. Single shot TAP block is performed using 30ml 0.5% ropivacaine at the end of the case."
27350|NCT02475031|O2|Outcome|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
27351|NCT02475031|O1|Outcome|Placebo Group (TAP-S)|"(TAP-S) – the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
27352|NCT02475031|E2|Reported Event|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
27353|NCT02475031|E1|Reported Event|Placebo Group (TAP-S)|"(TAP-S) – the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
27354|NCT02474901|B3|Baseline|Total|Total of all reporting groups
27355|NCT02474901|B2|Baseline|QLAIV, HIV-uninfected|"QLAIV administered to HIV-uninfected individuals 2 to 25 yoa~Quadrivalent Live Attenuated Influenza Vaccine"
27356|NCT02474901|B1|Baseline|QLAIV, HIV-infected|"QLAIV administered to HIV-infected individuals 2 to 25 yoa~Quadrivalent Live Attenuated Influenza Vaccine"
27357|NCT02474901|P2|Participant Flow|QLAIV, HIV-infected|"QLAIV administered to HIV-infected individuals 2 to 25 yoa~Quadrivalent Live Attenuated Influenza Vaccine"
27358|NCT02474901|P1|Participant Flow|QLAIV, HIV-uninfected|"QLAIV administered to HIV-uninfected individuals 2 to 25 yoa~Quadrivalent Live Attenuated Influenza Vaccine"
27359|NCT02474901|O2|Outcome|QLAIV, HIV-uninfected|"QLAIV administered to HIV-uninfected individuals 2 to 25 yoa~Quadrivalent Live Attenuated Influenza Vaccine"
27365|NCT02474901|O2|Outcome|QLAIV, HIV-uninfected|"QLAIV administered to HIV-uninfected individuals 2 to 25 yoa~Quadrivalent Live Attenuated Influenza Vaccine"
27366|NCT02474901|O1|Outcome|QLAIV, HIV-infected|"QLAIV administered to HIV-infected individuals 2 to 25 yoa~Quadrivalent Live Attenuated Influenza Vaccine"
27367|NCT02474901|O2|Outcome|QLAIV, HIV-uninfected|"QLAIV administered to HIV-uninfected individuals 2 to 25 yoa~Quadrivalent Live Attenuated Influenza Vaccine"
27368|NCT02474901|O1|Outcome|QLAIV, HIV-infected|"QLAIV administered to HIV-infected individuals 2 to 25 yoa~Quadrivalent Live Attenuated Influenza Vaccine"
27369|NCT02474901|E2|Reported Event|QLAIV, HIV-uninfected|Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) administered to HIV-uninfected individuals 2 to 25 yoa
27370|NCT02474901|E1|Reported Event|QLAIV, HIV-infected|Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) administered to HIV-infected individuals 2 to 25 yoa
27371|NCT02474589|B3|Baseline|Total|Total of all reporting groups
27372|NCT02474589|B2|Baseline|Placebo|"matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects~Placebo: Does not apply"
27373|NCT02474589|B1|Baseline|Active|"600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects~tecovirimat: Study is based on Animal Regulatory Rule"
27374|NCT02474589|P2|Participant Flow|Placebo|"matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects~Placebo: Does not apply"
27375|NCT02474589|P1|Participant Flow|Active|"600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects~tecovirimat: Study is based on Animal Regulatory Rule"
27376|NCT02474589|O2|Outcome|Placebo|"matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects~Placebo: Does not apply"
27377|NCT02474589|O1|Outcome|Active|"600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects~tecovirimat: Study is based on Animal Regulatory Rule"
27378|NCT02474589|E2|Reported Event|Placebo|"matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects~Placebo: Does not apply"
27379|NCT02474589|E1|Reported Event|Active|"600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects~tecovirimat: Study is based on Animal Regulatory Rule"
27380|NCT02474498|B4|Baseline|Total|Total of all reporting groups
27381|NCT02474498|B3|Baseline|EMD Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.~EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
27382|NCT02474498|B2|Baseline|EMD + βTCP/HA|During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces. The remaining part of the material in the seringe will be then mixed with the bone substitute on a sterile dappen. This mixture will be used to completely fill the defect (EMD + βTCP/HA).
27383|NCT02474498|B1|Baseline|βTCP/HA Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
27384|NCT02474498|P3|Participant Flow|EMD + βTCP/HA|During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces.This mixture will be used to completely fill the defect (EMD + βTCP/HA).
27385|NCT02474498|P2|Participant Flow|βTCP/HA Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
27406|NCT02474082|P1|Participant Flow|Secukinumab|Participants were self-administered subcutaneously (s.c.) with a dose of 300 milligrams (mg) of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 centimeters (cm) around the navel).
27386|NCT02474498|P1|Participant Flow|EMD Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.~EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
27387|NCT02474498|O3|Outcome|EMD + βTCP/HA|During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces.This mixture will be used to completely fill the defect (EMD + βTCP/HA).
27388|NCT02474498|O2|Outcome|βTCP/HA Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
27389|NCT02474498|O1|Outcome|EMD Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.~EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
27390|NCT02474498|O3|Outcome|EMD + βTCP/HA|During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces.This mixture will be used to completely fill the defect (EMD + βTCP/HA).
27391|NCT02474498|O2|Outcome|βTCP/HA Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
27392|NCT02474498|O1|Outcome|EMD Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.~EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
27393|NCT02474498|O3|Outcome|EMD Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.~EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
27394|NCT02474498|O2|Outcome|EMD + βTCP/HA|During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces. The remaining part of the material in the seringe will be then mixed with the bone substitute on a sterile dappen. This mixture will be used to completely fill the defect (EMD + βTCP/HA).
27407|NCT02474082|O2|Outcome|Fumaric Acid (Initial and Maintenance Therapy)|Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
27549|NCT02473471|O2|Outcome|Control Side|Non intervention side
36467|NCT02389088|O7|Outcome|Phase II - Week 5 - 0 Hours|
27395|NCT02474498|O1|Outcome|βTCP/HA Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
27396|NCT02474498|O3|Outcome|EMD Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.~EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
27397|NCT02474498|O2|Outcome|βTCP/HA + EMD|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces. The remaining part of the material in the seringe will be then mixed with the bone substitute on a sterile dappen. This mixture will be used to completely fill the defect (EMD + βTCP/HA).~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
27398|NCT02474498|O1|Outcome|βTCP/HA Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
27399|NCT02474498|E3|Reported Event|EMD Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.~EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
27400|NCT02474498|E2|Reported Event|βTCP/HA + EMD|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces. The remaining part of the material in the seringe will be then mixed with the bone substitute on a sterile dappen. This mixture will be used to completely fill the defect (EMD + βTCP/HA).~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
27401|NCT02474498|E1|Reported Event|βTCP/HA Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
27402|NCT02474082|B3|Baseline|Total|Total of all reporting groups
27403|NCT02474082|B2|Baseline|Fumaric Acid (Initial and Maintenance Therapy)|Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
27404|NCT02474082|B1|Baseline|Secukinumab|Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
27405|NCT02474082|P2|Participant Flow|Fumaric Acid (Initial and Maintenance Therapy)|Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
27550|NCT02473471|O1|Outcome|MOP Side|The Micro-osteoperforation side (The Intervention side)
27551|NCT02473471|O2|Outcome|Control Side|Non intervention side
27408|NCT02474082|O1|Outcome|Secukinumab|Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
27409|NCT02474082|O2|Outcome|Fumaric Acid (Initial and Maintenance Therapy)|Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
27410|NCT02474082|O1|Outcome|Secukinumab|Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
27411|NCT02474082|O2|Outcome|Fumaric Acid (Initial and Maintenance Therapy)|Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
27412|NCT02474082|O1|Outcome|Secukinumab|Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
27413|NCT02474082|O2|Outcome|Fumaric Acid (Initial and Maintenance Therapy)|Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
27414|NCT02474082|O1|Outcome|Secukinumab|Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
27415|NCT02474082|O2|Outcome|Fumaric Acid (Initial and Maintenance Therapy)|Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
27416|NCT02474082|O1|Outcome|Secukinumab|Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
27417|NCT02474082|O2|Outcome|Fumaric Acid (Initial and Maintenance Therapy)|Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
27418|NCT02474082|O1|Outcome|Secukinumab|Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
27419|NCT02474082|O2|Outcome|Fumaric Acid (Initial and Maintenance Therapy)|Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
27420|NCT02474082|O1|Outcome|Secukinumab|Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
27421|NCT02474082|O2|Outcome|Fumaric Acid (Initial and Maintenance Therapy)|Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
27422|NCT02474082|O1|Outcome|Secukinumab|Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
27423|NCT02474082|O2|Outcome|Fumaric Acid (Initial and Maintenance Therapy)|Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
27424|NCT02474082|O1|Outcome|Secukinumab|Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
27425|NCT02474082|O2|Outcome|Fumaric Acid (Initial and Maintenance Therapy)|Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
27426|NCT02474082|O1|Outcome|Secukinumab|Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
27427|NCT02474082|O2|Outcome|Fumaric Acid (Initial and Maintenance Therapy)|Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
27428|NCT02474082|O1|Outcome|Secukinumab|Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
27429|NCT02474082|O2|Outcome|Fumaric Acid (Initial and Maintenance Therapy)|Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
27430|NCT02474082|O1|Outcome|Secukinumab|Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
27431|NCT02474082|O2|Outcome|Fumaric Acid (Initial and Maintenance Therapy)|Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
27432|NCT02474082|O1|Outcome|Secukinumab|Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
27433|NCT02474082|O2|Outcome|Fumaric Acid (Initial and Maintenance Therapy)|Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
27434|NCT02474082|O1|Outcome|Secukinumab|Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
27435|NCT02474082|O2|Outcome|Fumaric Acid (Initial and Maintenance Therapy)|Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
27436|NCT02474082|O1|Outcome|Secukinumab|Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
27437|NCT02474082|E2|Reported Event|Fumaric Acid (Initial and Maintenance Therapy)|Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
27438|NCT02474082|E1|Reported Event|Secukinumab|Participants were self-administered subcutaneously (s.c.) with a dose of 300 milligrams (mg) of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 centimeters (cm) around the navel).
27439|NCT02473991|B1|Baseline|Pregnant Women|"All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, body mass index (BMI).~All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15–20 weeks of gestation) as well as third trimester (30–34 weeks of gestation).~The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al.(1985).~At the time of delivery , the birth weight (in grams), and mode of delivery was be taken.~After delivery, the umbilical cord was immediately clamped at its placental insertion to prevent loss of fetal blood, the maternal surface was dried with a towel, and the membranes were carefully trimmed at the placental margin. Each placenta was weighed within 15 minutes from delivery (Azpurua et al.,2010)."
27440|NCT02473991|P1|Participant Flow|Pregnant Women|"All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, body mass index (BMI).~All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15–20 weeks of gestation) as well as third trimester (30–34 weeks of gestation).~The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al.(1985).~At the time of delivery , the birth weight (in grams), and mode of delivery was be taken.~After delivery, the umbilical cord was immediately clamped at its placental insertion to prevent loss of fetal blood, the maternal surface was dried with a towel, and the membranes were carefully trimmed at the placental margin. Each placenta was weighed within 15 minutes from delivery (Azpurua et al.,2010)."
27441|NCT02473991|O1|Outcome|Pregnant Women|"All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, body mass index (BMI).~All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15–20 weeks of gestation) as well as third trimester (30–34 weeks of gestation).~The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al.(1985).~At the time of delivery , the birth weight (in grams), and mode of delivery was be taken.~After delivery, the umbilical cord was immediately clamped at its placental insertion to prevent loss of fetal blood, the maternal surface was dried with a towel, and the membranes were carefully trimmed at the placental margin. Each placenta was weighed within 15 minutes from delivery (Azpurua et al.,2010)."
27485|NCT02473640|E3|Reported Event|Treatment Period 2|In Treatment Period 2, subjects received 2 oral doses of 150mg SYN-004 and 1g ceftriaxone in the presence of esomeprazole. In Treatment Period 2 (ceftriaxone + SYN-004 + esomeprazole), 14 subjects were exposed to ceftriaxone, SYN-004, and esomeprazole. One subject did not receive study drug according to protocol.
36468|NCT02389088|O6|Outcome|Phase II - Week 0 - 24 Hours|
27442|NCT02473991|O1|Outcome|Pregnant Women|"All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, body mass index (BMI).~All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15–20 weeks of gestation) as well as third trimester (30–34 weeks of gestation).~The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al.(1985).~At the time of delivery , the birth weight (in grams), and mode of delivery was be taken.~After delivery, the umbilical cord was immediately clamped at its placental insertion to prevent loss of fetal blood, the maternal surface was dried with a towel, and the membranes were carefully trimmed at the placental margin. Each placenta was weighed within 15 minutes from delivery (Azpurua et al.,2010)."
27443|NCT02473991|O1|Outcome|Pregnant Women|"All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, body mass index (BMI).~All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15–20 weeks of gestation) as well as third trimester (30–34 weeks of gestation).~The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al.(1985).~At the time of delivery , the birth weight (in grams), and mode of delivery was be taken.~After delivery, the umbilical cord was immediately clamped at its placental insertion to prevent loss of fetal blood, the maternal surface was dried with a towel, and the membranes were carefully trimmed at the placental margin. Each placenta was weighed within 15 minutes from delivery (Azpurua et al.,2010)."
27444|NCT02473991|E1|Reported Event|Pregnant Women|"All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, body mass index (BMI).~All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15–20 weeks of gestation) as well as third trimester (30–34 weeks of gestation).~The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al.(1985).~At the time of delivery , the birth weight (in grams), and mode of delivery was be taken.~After delivery, the umbilical cord was immediately clamped at its placental insertion to prevent loss of fetal blood, the maternal surface was dried with a towel, and the membranes were carefully trimmed at the placental margin. Each placenta was weighed within 15 minutes from delivery (Azpurua et al.,2010)."
27445|NCT02473783|B3|Baseline|Total|Total of all reporting groups
27446|NCT02473783|B2|Baseline|Healthy Control Group|All healthy subjects (N=17) had only basal I-123-ADAM SPECT scanning.
27447|NCT02473783|B1|Baseline|Treatment Group|"The subjects with major depressive disorder who are screened into this study were scheduled for T1-weighted MRI (MRI examination results within 6 months before study are acceptable) prior to the visit of SPECT scans to confirm the absence of organic lesion in the brain and to co-register with SPECT images for the delineation of brain anatomical locations. After the screening visit, eligible subjects received I-123-ADAM SPECT before and after the pharmacological intervention with Sertraline HCl for a treatment period of six weeks. The subjects were observed until no clinically significant adverse events at the drug administration visits before being dismissed.~Sertraline HCl: The regimen of Sertraline HCl will be administered with starting dose from minimum 25 mg/day for 1 week and maintenance dose of at least 50 mg/day up to 200 mg/day for the rest of 5 weeks.~I-123-ADAM SPECT: The subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection."
27448|NCT02473783|P2|Participant Flow|Healthy Control Group|All healthy subjects had only basal I-123-ADAM SPECT scanning
27449|NCT02473783|P1|Participant Flow|Treatment Group|"The subjects with major depressive disorder who are screened into this study were scheduled for T1-weighted MRI (MRI examination results within 6 months before study are acceptable) prior to the visit of SPECT scans to confirm the absence of organic lesion in the brain and to co-register with SPECT images for the delineation of brain anatomical locations. After the screening visit, eligible subjects received I-123-ADAM SPECT before and after the pharmacological intervention with Sertraline HCl for a treatment period of six weeks. The subjects were observed until no clinically significant adverse events at the drug administration visits before being dismissed.~Sertraline HCl: The regimen of Sertraline HCl will be administered with starting dose from minimum 25 mg/day for 1 week and maintenance dose of at least 50 mg/day up to 200 mg/day for the rest of 5 weeks.~I-123-ADAM SPECT: The subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection."
27450|NCT02473783|O2|Outcome|Healthy Control Group|All healthy subjects had only basal I-123-ADAM SPECT scanning.
27451|NCT02473783|O1|Outcome|Treatment Group|"The subjects with major depressive disorder who are screened into this study were scheduled for T1-weighted MRI (MRI examination results within 6 months before study are acceptable) prior to the visit of SPECT scans to confirm the absence of organic lesion in the brain and to co-register with SPECT images for the delineation of brain anatomical locations. After the screening visit, eligible subjects received I-123-ADAM SPECT before and after the pharmacological intervention with Sertraline HCl for a treatment period of six weeks. The subjects were observed until no clinically significant adverse events at the drug administration visits before being dismissed.~Sertraline HCl: The regimen of Sertraline HCl will be administered with starting dose from minimum 25 mg/day for 1 week and maintenance dose of at least 50 mg/day up to 200 mg/day for the rest of 5 weeks.~I-123-ADAM SPECT: The subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection."
27452|NCT02473783|O1|Outcome|Treatment Group|The subjects with major depressive disorder were assessed with Hamilton Depression Rating Scale (HAM-D) before and after 6 weeks of Sertraline HCl treatment.
27486|NCT02473640|E2|Reported Event|Run-in Period|Treatment Periods 1 and 2 were separated by a 5- to 7-day run-in phase, during which subjects self-administered 40 mg of esomeprazole once daily in the morning.
27487|NCT02473640|E1|Reported Event|Treatment Period 1|In Treatment Period 1 (ceftriaxone + SYN-004), all 15 enrolled subjects received 1 g ceftriaxone and 14 received both 150 mg doses of SYN-004. One subject received only one 150 mg dose of SYN-004. In Treatment Period 1, one subject was discontinued from the study prior to receiving the second dose of SYN-004 due to a stoma site hemorrhage. The subject did not continue into the run-in phase or Treatment Period 2.
27552|NCT02473471|O1|Outcome|MOP Side|The Micro-osteoperforation side (The Intervention side)
36469|NCT02389088|O5|Outcome|Phase I - Week 6 - 24 Hour|
27453|NCT02473783|O1|Outcome|Treatment Group|"The subjects with major depressive disorder who are screened into this study were scheduled for T1-weighted MRI (MRI examination results within 6 months before study are acceptable) prior to the visit of SPECT scans to confirm the absence of organic lesion in the brain and to co-register with SPECT images for the delineation of brain anatomical locations. After the screening visit, eligible subjects received I-123-ADAM SPECT before and after the pharmacological intervention with Sertraline HCl for a treatment period of six weeks. The subjects were observed until no clinically significant adverse events at the drug administration visits before being dismissed.~Sertraline HCl: The regimen of Sertraline HCl will be administered with starting dose from minimum 25 mg/day for 1 week and maintenance dose of at least 50 mg/day up to 200 mg/day for the rest of 5 weeks.~I-123-ADAM SPECT: The subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection."
27454|NCT02473783|E2|Reported Event|Healthy Control Group|All healthy subjects had only basal I-123-ADAM SPECT scanning.
27455|NCT02473783|E1|Reported Event|Treatment Group|"The subjects with major depressive disorder who are screened into this study were scheduled for T1-weighted MRI (MRI examination results within 6 months before study are acceptable) prior to the visit of SPECT scans to confirm the absence of organic lesion in the brain and to co-register with SPECT images for the delineation of brain anatomical locations. After the screening visit, eligible subjects received I-123-ADAM SPECT before and after the pharmacological intervention with Sertraline HCl for a treatment period of six weeks. The subjects were observed until no clinically significant adverse events at the drug administration visits before being dismissed.~Sertraline HCl: The regimen of Sertraline HCl will be administered with starting dose from minimum 25 mg/day for 1 week and maintenance dose of at least 50 mg/day up to 200 mg/day for the rest of 5 weeks.~I-123-ADAM SPECT: The subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection."
27456|NCT02473718|B3|Baseline|Total|Total of all reporting groups
27457|NCT02473718|B2|Baseline|Usual Care Group|Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.
27458|NCT02473718|B1|Baseline|Fluid Minimization Group|"Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Intubated patients will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. Fluid challenge as a leg raise or infusion of 250 mL of crystalloid over 5 minutes will be performed and parameters repeated. Fluid responsiveness based on the changes in the parameters. Fluid nonresponsive patients will undergo the fluid minimization protocol.~Fluid minimization protocol: Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance."
27459|NCT02473718|P2|Participant Flow|Usual Care Group|Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.
27460|NCT02473718|P1|Participant Flow|Fluid Minimization Group|"Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Intubated patients will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. Fluid challenge as a leg raise or infusion of 250 mL of crystalloid over 5 minutes will be performed and parameters repeated. Fluid responsiveness based on the changes in the parameters. Fluid nonresponsive patients will undergo the fluid minimization protocol.~Fluid minimization protocol: Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance."
27461|NCT02473718|O2|Outcome|Usual Care Group|Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.
27462|NCT02473718|O1|Outcome|Fluid Minimization Group|"Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Intubated patients will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. Fluid challenge as a leg raise or infusion of 250 mL of crystalloid over 5 minutes will be performed and parameters repeated. Fluid responsiveness based on the changes in the parameters. Fluid nonresponsive patients will undergo the fluid minimization protocol.~Fluid minimization protocol: Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance."
27463|NCT02473718|O2|Outcome|Usual Care Group|Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.
27488|NCT02473523|B1|Baseline|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
36470|NCT02389088|O4|Outcome|Phase I - Week 6 - 0 Hour|
27464|NCT02473718|O1|Outcome|Fluid Minimization Group|"Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Intubated patients will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. Fluid challenge as a leg raise or infusion of 250 mL of crystalloid over 5 minutes will be performed and parameters repeated. Fluid responsiveness based on the changes in the parameters. Fluid nonresponsive patients will undergo the fluid minimization protocol.~Fluid minimization protocol: Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance."
27465|NCT02473718|O2|Outcome|Usual Care Group|Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.
27466|NCT02473718|O1|Outcome|Fluid Minimization Group|"Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Intubated patients will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. Fluid challenge as a leg raise or infusion of 250 mL of crystalloid over 5 minutes will be performed and parameters repeated. Fluid responsiveness based on the changes in the parameters. Fluid nonresponsive patients will undergo the fluid minimization protocol.~Fluid minimization protocol: Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance."
27467|NCT02473718|O2|Outcome|Usual Care Group|Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.
27468|NCT02473718|O1|Outcome|Fluid Minimization Group|"Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Intubated patients will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. Fluid challenge as a leg raise or infusion of 250 mL of crystalloid over 5 minutes will be performed and parameters repeated. Fluid responsiveness based on the changes in the parameters. Fluid nonresponsive patients will undergo the fluid minimization protocol.~Fluid minimization protocol: Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance."
27469|NCT02473718|O2|Outcome|Usual Care Group|Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.
27470|NCT02473718|O1|Outcome|Fluid Minimization Group|"Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Intubated patients will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. Fluid challenge as a leg raise or infusion of 250 mL of crystalloid over 5 minutes will be performed and parameters repeated. Fluid responsiveness based on the changes in the parameters. Fluid nonresponsive patients will undergo the fluid minimization protocol.~Fluid minimization protocol: Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance."
27471|NCT02473718|O2|Outcome|Usual Care Group|Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.
27472|NCT02473718|O1|Outcome|Fluid Minimization Group|"Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Intubated patients will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. Fluid challenge as a leg raise or infusion of 250 mL of crystalloid over 5 minutes will be performed and parameters repeated. Fluid responsiveness based on the changes in the parameters. Fluid nonresponsive patients will undergo the fluid minimization protocol.~Fluid minimization protocol: Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance."
27473|NCT02473718|O2|Outcome|Usual Care Group|Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.
27542|NCT02473471|O1|Outcome|MOP Side|Three small holes in cortical bone can be created by Miniscrews.Before application of the MOPs, Patient will be asked to wash their mouth twice by chlorhexidine for 1 minute. Local anesthesia will be given (2% lidocaine with 1:100,000 epinephrine). Microosteoperforation (MOPs) will be performed distal to canine.
27474|NCT02473718|O1|Outcome|Fluid Minimization Group|"Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Intubated patients will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. Fluid challenge as a leg raise or infusion of 250 mL of crystalloid over 5 minutes will be performed and parameters repeated. Fluid responsiveness based on the changes in the parameters. Fluid nonresponsive patients will undergo the fluid minimization protocol.~Fluid minimization protocol: Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance."
27475|NCT02473718|O2|Outcome|Usual Care Group|Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.
27476|NCT02473718|O1|Outcome|Fluid Minimization Group|"Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Intubated patients will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. Fluid challenge as a leg raise or infusion of 250 mL of crystalloid over 5 minutes will be performed and parameters repeated. Fluid responsiveness based on the changes in the parameters. Fluid nonresponsive patients will undergo the fluid minimization protocol.~Fluid minimization protocol: Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance."
27477|NCT02473718|E2|Reported Event|Usual Care Group|Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.
27478|NCT02473718|E1|Reported Event|Fluid Minimization Group|"Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Intubated patients will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. Fluid challenge as a leg raise or infusion of 250 mL of crystalloid over 5 minutes will be performed and parameters repeated. Fluid responsiveness based on the changes in the parameters. Fluid nonresponsive patients will undergo the fluid minimization protocol.~Fluid minimization protocol: Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance."
27479|NCT02473640|B1|Baseline|150 mg SYN-004|"There will be 2 in-house treatment periods: in Treatment Period 1, subjects will receive 2 oral doses of 150 mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone, and in Treatment Period 2, subjects will receive 2 oral doses of 150mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone in the presence of steady-state esomeprazole; Treatment Periods 1 and 2 will be separated by a 5- to 7-day run-in phase, during which subjects will self-administer 40 mg of esomeprazole once daily (QD) in the morning, at home.~SYN-004~Esomeprazole~Ceftriaxone"
27480|NCT02473640|P1|Participant Flow|150 mg SYN-004|"There will be 2 in-house treatment periods: in Treatment Period 1, subjects will receive 2 oral doses of 150 mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone, and in Treatment Period 2, subjects will receive 2 oral doses of 150mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone in the presence of esomeprazole; Treatment Periods 1 and 2 will be separated by a 5- to 7-day run-in phase, during which subjects will self-administer 40 mg of esomeprazole once daily (QD) in the morning, at home.~SYN-004~Esomeprazole~Ceftriaxone"
27481|NCT02473640|O1|Outcome|150 mg SYN-004|"There will be 2 in-house treatment periods: in Treatment Period 1, subjects will receive 2 oral doses of 150 mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone, and in Treatment Period 2, subjects will receive 2 oral doses of 150mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone in the presence of esomeprazole; Treatment Periods 1 and 2 will be separated by a 5- to 7-day run-in phase, during which subjects will self-administer 40 mg of esomeprazole once daily (QD) in the morning, at home.~SYN-004~Esomeprazole~Ceftriaxone"
27482|NCT02473640|O1|Outcome|150 mg SYN-004|"There will be 2 in-house treatment periods: in Treatment Period 1, subjects will receive 2 oral doses of 150 mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone, and in Treatment Period 2, subjects will receive 2 oral doses of 150mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone in the presence of esomeprazole; Treatment Periods 1 and 2 will be separated by a 5- to 7-day run-in phase, during which subjects will self-administer 40 mg of esomeprazole once daily (QD) in the morning, at home.~SYN-004~Esomeprazole~Ceftriaxone"
27483|NCT02473640|O1|Outcome|150 mg SYN-004|"There will be 2 in-house treatment periods: in Treatment Period 1, subjects will receive 2 oral doses of 150 mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone, and in Treatment Period 2, subjects will receive 2 oral doses of 150mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone in the presence of esomeprazole; Treatment Periods 1 and 2 will be separated by a 5- to 7-day run-in phase, during which subjects will self-administer 40 mg of esomeprazole once daily (QD) in the morning, at home.~SYN-004~Esomeprazole~Ceftriaxone"
27484|NCT02473640|O1|Outcome|150 mg SYN-004|There will be 2 in-house treatment periods: in Treatment Period 1, subjects will receive 2 oral doses of 150 mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone, and in Treatment Period 2, subjects will receive 2 oral doses of 150mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone in the presence of esomeprazole; Treatment Periods 1 and 2 will be separated by a 5- to 7-day run-in phase, during which subjects will self-administer 40 mg of esomeprazole once daily (QD) in the morning, at home.
27543|NCT02473471|O2|Outcome|Control Side|No intervention in the other side of maxilla (control side)
27553|NCT02473471|E2|Reported Event|Control Side|No intervention in the other side of maxilla (control side)
36471|NCT02389088|O3|Outcome|Phase I - Week 5 - 24 Hour|
27489|NCT02473523|P1|Participant Flow|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
27490|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
27491|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
27492|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
27493|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
27494|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
27495|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
27496|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
27497|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
27498|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
27499|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
27500|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
27501|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
27502|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
27503|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
27504|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
27544|NCT02473471|O1|Outcome|MOP Side|Three small holes in cortical bone can be created by Miniscrews.Before application of the MOPs, Patient will be asked to wash their mouth twice by chlorhexidine for 1 minute. Local anesthesia will be given (2% lidocaine with 1:100,000 epinephrine). Microosteoperforation (MOPs) will be performed distal to canine.
27505|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
27506|NCT02473523|E1|Reported Event|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
27507|NCT02473510|B3|Baseline|Total|Total of all reporting groups
27508|NCT02473510|B2|Baseline|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
27509|NCT02473510|B1|Baseline|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
27510|NCT02473510|P2|Participant Flow|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
27511|NCT02473510|P1|Participant Flow|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
27512|NCT02473510|O2|Outcome|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
27513|NCT02473510|O1|Outcome|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
27514|NCT02473510|O2|Outcome|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
27515|NCT02473510|O1|Outcome|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
27516|NCT02473510|O2|Outcome|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
27517|NCT02473510|O1|Outcome|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
27518|NCT02473510|O2|Outcome|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
27519|NCT02473510|O1|Outcome|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
27520|NCT02473510|O2|Outcome|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
27521|NCT02473510|O1|Outcome|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
27522|NCT02473510|E2|Reported Event|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
27523|NCT02473510|E1|Reported Event|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
27524|NCT02473471|B1|Baseline|All Study Participants|Includes groups randomized to receive MOP intervention on one side while the other side serve as control side.
27525|NCT02473471|P1|Participant Flow|All Study Participants|"Split-mouth design study in which the intervention (MOP Side) was randomly assigned to either right or the left side in the maxillary arch where other side serves as a control.~Randomization was accomplished with block randomization with a permuted block size of 2 with 1:1 allocation ratio to either right or left with allocations concealed in opaque, sealed envelopes. Blinding was applicable at data collection and analysis stage."
27526|NCT02473471|O2|Outcome|Control Side|Non intervention side
27527|NCT02473471|O1|Outcome|MOP Side|The Micro-osteoperforation side (The Intervention side)
27528|NCT02473471|O1|Outcome|MOP Side|The Micro-osteoperforation side (The Intervention side)
27529|NCT02473471|O2|Outcome|Control Side|No intervention in the other side of maxilla (control side)
27530|NCT02473471|O1|Outcome|MOP Side|The Micro-osteoperforation side (The Intervention side)
27531|NCT02473471|O2|Outcome|Control Side|No intervention in the other side of maxilla (control side)
27532|NCT02473471|O1|Outcome|MOP Side|The Micro-osteoperforation side (The Intervention side)
27533|NCT02473471|O2|Outcome|Control Side|No intervention in the other side of maxilla (control side)
27534|NCT02473471|O1|Outcome|MOP Side|The Micro-osteoperforation side (The Intervention side)
27535|NCT02473471|O2|Outcome|Control Side|No intervention in the other side of maxilla (control side)
27536|NCT02473471|O1|Outcome|MOP Side|The Micro-osteoperforation side (The Intervention side)
27537|NCT02473471|O2|Outcome|Control Side|Non-intervention side
27538|NCT02473471|O1|Outcome|MOP Side|The Micro-osteoperforation side
27539|NCT02473471|O2|Outcome|Control Side|Non-intervention side
27540|NCT02473471|O1|Outcome|MOP Side|The Micro-osteoperforation side
27541|NCT02473471|O2|Outcome|Control Side|No intervention in the other side of maxilla (control side)
27545|NCT02473471|O2|Outcome|Control Side|No intervention in the other side of maxilla (control side)
27554|NCT02473471|E1|Reported Event|MOP Side|"Three small holes in cortical bone can be created by Miniscrews.Before application of the MOPs, Patient will be asked to wash their mouth twice by chlorhexidine for 1 minute. Local anesthesia will be given (2% lidocaine with 1:100,000 epinephrine). Microosteoperforation (MOPs) will be performed distal to canine.~Micro-osteoperforation: Three Micro-osteoperforation (MOPs) will be performed distal to canine by Mini screw. Before the application of the MOPs, Patient will be asked to wash their mouth twice by chorhexidine for 1 minute."
27555|NCT02473445|B1|Baseline|Cysteamine Bitartrate Delayed-release|Participants received cysteamine bitartrate delayed-release capsules (RP103) twice daily for up to 2 years. The starting dose was the same as the last dose received in study RP103-MITO-001, the maximum dose was 1.3 g/m²/day.
27556|NCT02473445|P1|Participant Flow|Cysteamine Bitartrate Delayed-release|Participants received cysteamine bitartrate delayed-release capsules (RP103) twice daily for up to 2 years. The starting dose was the same as the last dose received in study RP103-MITO-001, the maximum dose was 1.3 g/m²/day.
27557|NCT02473445|O1|Outcome|Cysteamine Bitartrate Delayed-release|Participants received cysteamine bitartrate delayed-release capsules (RP103) twice daily for up to 2 years. The starting dose was the same as the last dose received in study RP103-MITO-001, the maximum dose was 1.3 g/m²/day.
27558|NCT02473445|O1|Outcome|Cysteamine Bitartrate Delayed-release|Participants received cysteamine bitartrate delayed-release capsules (RP103) twice daily for up to 2 years. The starting dose was the same as the last dose received in study RP103-MITO-001, the maximum dose was 1.3 g/m²/day.
27559|NCT02473445|O1|Outcome|Cysteamine Bitartrate Delayed-release|Participants received cysteamine bitartrate delayed-release capsules (RP103) twice daily for up to 2 years. The starting dose was the same as the last dose received in study RP103-MITO-001, the maximum dose was 1.3 g/m²/day.
27560|NCT02473445|E1|Reported Event|Cysteamine Bitartrate Delayed-release|Participants received cysteamine bitartrate delayed-release capsules (RP103) twice daily for up to 2 years. The starting dose was the same as the last dose received in study RP103-MITO-001, the maximum dose was 1.3 g/m²/day.
27561|NCT02473367|B1|Baseline|All Enrolled Participants|All participants who enrolled in the study
27562|NCT02473367|P1|Participant Flow|Four Period Fixed Sequence|All participants entered the first of four treatment periods. Period 1: 1200 mg raltegravir alone; followed by Period 2: 1200 mg raltegravir and TUMS Ultra Strength (US) 1000 taken orally concomitantly; followed by Period 3: 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid Maximum Strength (MS) taken orally; followed by Period 4: 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. There was a maximum 7-day wait between each period where participants were treated once daily with 1200 mg raltegravir.
27563|NCT02473367|O4|Outcome|Period 4: Raltegravir + 12 Hrs TUMS|1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000
27564|NCT02473367|O3|Outcome|Period 3: Raltegravir + 12 Hrs Leader Antacid|1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS
27565|NCT02473367|O2|Outcome|Period 2: Raltegravir + TUMS Concomitantly|1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2
27566|NCT02473367|O1|Outcome|Period 1: Raltegravir Only|1200 mg raltegravir, once at the start of Period 1
27567|NCT02473367|O4|Outcome|Period 4: Raltegravir + 12 Hrs TUMS|1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000
27568|NCT02473367|O3|Outcome|Period 3: Raltegravir + 12 Hrs Leader Antacid|1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS
27569|NCT02473367|O2|Outcome|Period 2: Raltegravir + TUMS Concomitantly|1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2
27570|NCT02473367|O1|Outcome|Period 1: Raltegravir Only|1200 mg raltegravir, once at the start of Period 1
27571|NCT02473367|O4|Outcome|Period 4: Raltegravir + 12 Hrs TUMS|1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000
27572|NCT02473367|O3|Outcome|Period 3: Raltegravir + 12 Hrs Leader Antacid|1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS
27573|NCT02473367|O2|Outcome|Period 2: Raltegravir + TUMS Concomitantly|1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2
27574|NCT02473367|O1|Outcome|Period 1: Raltegravir Only|1200 mg raltegravir, once at the start of Period 1
27575|NCT02473367|E4|Reported Event|Period 4: Raltegravir + 12 Hrs TUMS|1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000
27576|NCT02473367|E3|Reported Event|Period 3: Raltegravir + 12 Hrs Leader Antacid|1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS
27577|NCT02473367|E2|Reported Event|Period 2: Raltegravir + TUMS Concomitantly|1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2
27578|NCT02473367|E1|Reported Event|Period 1: Raltegravir Only|1200 mg raltegravir, once at the start of Period 1
27579|NCT02472977|B4|Baseline|Total|Total of all reporting groups
27580|NCT02472977|B3|Baseline|SCLC (Tot)|All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27581|NCT02472977|B2|Baseline|PAC DL-1 (Tot)|Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27582|NCT02472977|B1|Baseline|PAC DL1 (DLT)|Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27583|NCT02472977|P3|Participant Flow|SCLC (Tot)|All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27584|NCT02472977|P2|Participant Flow|PAC DL-1 (Tot)|Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27585|NCT02472977|P1|Participant Flow|PAC DL1 (DLT)|Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27586|NCT02472977|O3|Outcome|SCLC (Tot)|All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27587|NCT02472977|O2|Outcome|PAC DL-1 (Tot)|Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27588|NCT02472977|O1|Outcome|PAC DL1 (DLT)|Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27589|NCT02472977|O3|Outcome|SCLC (Tot)|All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27590|NCT02472977|O2|Outcome|PAC DL-1 (Tot)|Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27591|NCT02472977|O1|Outcome|PAC DL1 (DLT)|Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27592|NCT02472977|O3|Outcome|SCLC (Tot)|All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27593|NCT02472977|O2|Outcome|PAC DL-1 (Tot)|Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27594|NCT02472977|O1|Outcome|PAC DL1 (DLT)|Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27595|NCT02472977|O3|Outcome|SCLC (Tot)|All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27596|NCT02472977|O2|Outcome|PAC DL-1 (Tot)|Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27597|NCT02472977|O1|Outcome|PAC DL1 (DLT)|Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27598|NCT02472977|O3|Outcome|SCLC (Tot)|All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27599|NCT02472977|O2|Outcome|PAC DL-1 (Tot)|Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27600|NCT02472977|O1|Outcome|PAC DL1 (DLT)|Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27601|NCT02472977|O3|Outcome|SCLC (Tot)|All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27602|NCT02472977|O2|Outcome|PAC DL-1 (Tot)|Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27603|NCT02472977|O1|Outcome|PAC DL1 (DLT)|Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27604|NCT02472977|E3|Reported Event|SCLC (Tot)|All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27605|NCT02472977|E2|Reported Event|PAC DL-1 (Tot)|Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27606|NCT02472977|E1|Reported Event|PAC DL1 (DLT)|Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
27607|NCT02472886|B4|Baseline|Total|Total of all reporting groups
27608|NCT02472886|B3|Baseline|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
27609|NCT02472886|B2|Baseline|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
27610|NCT02472886|B1|Baseline|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF(90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
27611|NCT02472886|P3|Participant Flow|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve sustained virologic response (SVR) in a previous Gilead sofosbuvir (SOF) study
27612|NCT02472886|P2|Participant Flow|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
27613|NCT02472886|P1|Participant Flow|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|Ledipasvir/sofosbuvir (LDV/SOF; Harvoni®) (90/400 mg) fixed dose combination (FDC) tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
27614|NCT02472886|O2|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected, ARV Experienced)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1. These participants were on a stable ARV regimen for at least 8 weeks prior to screening.
27615|NCT02472886|O1|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected, ARV- Naive)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1. These participants did not receive any prior ARV therapy.
27616|NCT02472886|O1|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
27617|NCT02472886|O3|Outcome|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
27618|NCT02472886|O2|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
27619|NCT02472886|O1|Outcome|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosiss
27620|NCT02472886|O3|Outcome|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
27665|NCT02472639|O1|Outcome|Ostom-i Alert Sensor|"Patients will wear Ostom-i sensor~Ostom-i Alert Sensor: Wear the Ostom-i Alert Sensor"
27621|NCT02472886|O2|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
27622|NCT02472886|O1|Outcome|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
27623|NCT02472886|O3|Outcome|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
27624|NCT02472886|O2|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
27625|NCT02472886|O1|Outcome|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
27626|NCT02472886|O3|Outcome|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
27627|NCT02472886|O2|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
27628|NCT02472886|O1|Outcome|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
27629|NCT02472886|O3|Outcome|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
27630|NCT02472886|O2|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
27631|NCT02472886|O1|Outcome|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
27632|NCT02472886|O3|Outcome|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
27633|NCT02472886|O2|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
27634|NCT02472886|O1|Outcome|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
27635|NCT02472886|E3|Reported Event|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
27636|NCT02472886|E2|Reported Event|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
27637|NCT02472886|E1|Reported Event|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
27638|NCT02472847|B3|Baseline|Total|Total of all reporting groups
27639|NCT02472847|B2|Baseline|Dronabinol|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning~Dronabinol: Dronabinol (7.5mg) is administered only once by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants will receive dronabinol."
27640|NCT02472847|B1|Baseline|Placebo|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning.~Placebo: Placebo is administered only once by the oral route and contains only dextrose in opaque capsules. Half of the participants will receive placebo."
27641|NCT02472847|P2|Participant Flow|Dronabinol|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning~Dronabinol: Dronabinol (7.5mg) is administered only once by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants will receive dronabinol."
27642|NCT02472847|P1|Participant Flow|Placebo|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning.~Placebo: Placebo is administered only once by the oral route and contains only dextrose in opaque capsules. Half of the participants will receive placebo."
27666|NCT02472639|O2|Outcome|No Ostom-i Alert Sensor|"Patient will not wear Ostom-i sensor~No Ostom-i Alert Sensor: Patient will not use device"
27667|NCT02472639|O1|Outcome|Ostom-i Alert Sensor|"Patients will wear Ostom-i sensor~Ostom-i Alert Sensor: Wear the Ostom-i Alert Sensor"
27643|NCT02472847|O2|Outcome|Dronabinol|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning~Dronabinol: Dronabinol (7.5mg) is administered only once by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants will receive dronabinol."
27644|NCT02472847|O1|Outcome|Placebo|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning.~Placebo: Placebo is administered only once by the oral route and contains only dextrose in opaque capsules. Half of the participants will receive placebo."
27645|NCT02472847|E2|Reported Event|Dronabinol|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning~Dronabinol: Dronabinol (7.5mg) is administered only once by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants will receive dronabinol."
27646|NCT02472847|E1|Reported Event|Placebo|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning.~Placebo: Placebo is administered only once by the oral route and contains only dextrose in opaque capsules. Half of the participants will receive placebo."
27647|NCT02472756|B1|Baseline|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
27648|NCT02472756|P1|Participant Flow|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician’s discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
27649|NCT02472756|O1|Outcome|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
27650|NCT02472756|O1|Outcome|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
27651|NCT02472756|O1|Outcome|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
27652|NCT02472756|E1|Reported Event|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
27653|NCT02472639|B3|Baseline|Total|Total of all reporting groups
27654|NCT02472639|B2|Baseline|No Ostom-i Alert Sensor|"Patient will not wear Ostom-i sensor~No Ostom-i Alert Sensor: Patient will not use device"
27655|NCT02472639|B1|Baseline|Ostom-i Alert Sensor|"Patients will wear Ostom-i sensor~Ostom-i Alert Sensor: Wear the Ostom-i Alert Sensor"
27656|NCT02472639|P2|Participant Flow|No Ostom-i Alert Sensor|"Patient will not wear Ostom-i sensor~No Ostom-i Alert Sensor: Patient will not use device"
27657|NCT02472639|P1|Participant Flow|Ostom-i Alert Sensor|"Patients will wear Ostom-i sensor~Ostom-i Alert Sensor: Wear the Ostom-i Alert Sensor"
27658|NCT02472639|O2|Outcome|No Ostom-i Alert Sensor|"Patient will not wear Ostom-i sensor~No Ostom-i Alert Sensor: Patient will not use device"
27659|NCT02472639|O1|Outcome|Ostom-i Alert Sensor|"Patients will wear Ostom-i sensor~Ostom-i Alert Sensor: Wear the Ostom-i Alert Sensor"
27660|NCT02472639|O2|Outcome|No Ostom-i Alert Sensor|"Patient will not wear Ostom-i sensor~No Ostom-i Alert Sensor: Patient will not use device"
27661|NCT02472639|O1|Outcome|Ostom-i Alert Sensor|"Patients will wear Ostom-i sensor~Ostom-i Alert Sensor: Wear the Ostom-i Alert Sensor"
27662|NCT02472639|O2|Outcome|No Ostom-i Alert Sensor|"Patient will not wear Ostom-i sensor~No Ostom-i Alert Sensor: Patient will not use device"
27663|NCT02472639|O1|Outcome|Ostom-i Alert Sensor|"Patients will wear Ostom-i sensor~Ostom-i Alert Sensor: Wear the Ostom-i Alert Sensor"
27664|NCT02472639|O2|Outcome|No Ostom-i Alert Sensor|"Patient will not wear Ostom-i sensor~No Ostom-i Alert Sensor: Patient will not use device"
27668|NCT02472639|E2|Reported Event|No Ostom-i Alert Sensor|"Patient will not wear Ostom-i sensor~No Ostom-i Alert Sensor: Patient will not use device"
27669|NCT02472639|E1|Reported Event|Ostom-i Alert Sensor|"Patients will wear Ostom-i sensor~Ostom-i Alert Sensor: Wear the Ostom-i Alert Sensor"
27670|NCT02472522|B3|Baseline|Total|Total of all reporting groups
27671|NCT02472522|B2|Baseline|Ropivacaine + Dexmedetomidine|"Patients satisfying the inclusion criteria received Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block was performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
27672|NCT02472522|B1|Baseline|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block was performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will received Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
27673|NCT02472522|P2|Participant Flow|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
27674|NCT02472522|P1|Participant Flow|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
27675|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
27676|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
27677|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
27678|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
27679|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
27680|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
27704|NCT02472366|B2|Baseline|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
27705|NCT02472366|B1|Baseline|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
28370|NCT02465450|O1|Outcome|JBT101 1 mg QD|JBT-101: 1 mg once a day on Days 1-28
27681|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
27682|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
27683|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
27684|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
27685|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
27686|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
27687|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
27688|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
27689|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
27690|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
27691|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying the inclusion criteria received Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block was performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
27706|NCT02472366|P2|Participant Flow|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
27692|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block was performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will received Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
27693|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
27694|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
27695|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
27696|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
27697|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
27698|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
27699|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
27700|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
27701|NCT02472522|E2|Reported Event|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
27702|NCT02472522|E1|Reported Event|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
27703|NCT02472366|B3|Baseline|Total|Total of all reporting groups
27707|NCT02472366|P1|Participant Flow|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
27708|NCT02472366|O2|Outcome|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
27709|NCT02472366|O1|Outcome|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
27710|NCT02472366|O2|Outcome|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
27711|NCT02472366|O1|Outcome|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
27712|NCT02472366|O2|Outcome|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
27713|NCT02472366|O1|Outcome|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
27714|NCT02472366|O2|Outcome|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
27715|NCT02472366|O1|Outcome|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
27716|NCT02472366|O2|Outcome|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
27717|NCT02472366|O1|Outcome|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
27718|NCT02472366|E2|Reported Event|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
27719|NCT02472366|E1|Reported Event|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
27720|NCT02471755|B3|Baseline|Total|Total of all reporting groups
27721|NCT02471755|B2|Baseline|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
27722|NCT02471755|B1|Baseline|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
27723|NCT02471755|P2|Participant Flow|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
27724|NCT02471755|P1|Participant Flow|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
27725|NCT02471755|O2|Outcome|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
27726|NCT02471755|O1|Outcome|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
27755|NCT02471612|E1|Reported Event|APACHE-2 Scoring|All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with APACHE II on the day of surgery.
27756|NCT02471326|B1|Baseline|HIV Positive Subjects|Drug: VRC-HIVMAB060-00-AB (VRCO1), 40 mg/kg in 100 mL Normal Saline; VRC-HIVMAB060-00-AB (VRCO1) is a potent HIV-specific monoclonal antibody which was given at Baseline, Week 2, and then every 4 weeks for up to a total of 8 doses
28606|NCT02461693|O2|Outcome|Placebo|"One-time treatment with lactose-based placebo pill~Placebo"
27727|NCT02471755|O2|Outcome|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
27728|NCT02471755|O1|Outcome|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
27729|NCT02471755|O2|Outcome|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
27730|NCT02471755|O1|Outcome|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
27731|NCT02471755|O2|Outcome|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
27732|NCT02471755|O1|Outcome|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
27733|NCT02471755|O2|Outcome|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
27734|NCT02471755|O1|Outcome|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
27735|NCT02471755|O2|Outcome|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
27757|NCT02471326|P1|Participant Flow|HIV Positive Subjects|Drug: VRC-HIVMAB060-00-AB (VRCO1), 40 mg/kg in 100 mL Normal Saline; VRC-HIVMAB060-00-AB (VRCO1) is a potent HIV-specific monoclonal antibody which was given at Baseline, Week 2, and then every 4 weeks for up to a total of 8 doses
28608|NCT02461693|O2|Outcome|Placebo|"One-time treatment with lactose-based placebo pill~Placebo"
27736|NCT02471755|O1|Outcome|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
27737|NCT02471755|E2|Reported Event|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
27738|NCT02471755|E1|Reported Event|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
27739|NCT02471612|B1|Baseline|Emergency Laparotomy|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria were scored using the APACHE-2 Score & P-POSSUM Score
27740|NCT02471612|P1|Participant Flow|All Patients Who Underwent Emergency Exploratory Laparotomy|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria were scored using the P-POSSUM Score APACHE-II
27741|NCT02471612|O2|Outcome|Patients Who Died|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were observed if they needed re-exploration during the post-operative period.
27742|NCT02471612|O1|Outcome|Patients Who Survived|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were observed if they needed re-exploration during the post-operative period.
27743|NCT02471612|O2|Outcome|Patients Who Died|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were monitored for the Acute Kidney Injury
27744|NCT02471612|O1|Outcome|Patients Who Survived|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were monitored for the Acute Kidney Injury
27745|NCT02471612|O2|Outcome|Patients Who Died|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were monitored for Cardiac morbidity (Acute Myocardial Infarction (AMI) or arrhythmias needing treatment)
27746|NCT02471612|O1|Outcome|Patients Who Survived|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were monitored for Cardiac morbidity (Acute Myocardial Infarction (AMI) or arrhythmias needing treatment)
27747|NCT02471612|O2|Outcome|Patients Who Died|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were monitored for the need for inotropic support during their stay..
27748|NCT02471612|O1|Outcome|Surviving Patients|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were monitored for the need for inotropic support during their stay..
27749|NCT02471612|O2|Outcome|Patients Who Died|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were observed if they needed ventilatory support postoperatively
27750|NCT02471612|O1|Outcome|Surviving Patients|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were observed if they needed ventilatory support postoperatively
27751|NCT02471612|O1|Outcome|Length of Stay|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria were observed for their length of stay (LOS)
27752|NCT02471612|O2|Outcome|AUC Using P-POSSUM|All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with P-POSSUM on the day of surgery.
27753|NCT02471612|O1|Outcome|AUC Using APACHE II|All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with APACHE II on the day of surgery.
27754|NCT02471612|E2|Reported Event|P-POSSUM|All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with P-POSSUM on the day of surgery
27798|NCT02470429|P2|Participant Flow|Hyabak 0.15%|Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
27758|NCT02471326|O1|Outcome|HIV Positive Subjects|Drug: VRC-HIVMAB060-00-AB (VRCO1), 40 mg/kg in 100 mL Normal Saline; VRC-HIVMAB060-00-AB (VRCO1) is a potent HIV-specific monoclonal antibody which was given at Baseline, Week 2, and then every 4 weeks for up to a total of 8 doses
27759|NCT02471326|O1|Outcome|HIV Positive Subjects|Drug: VRC-HIVMAB060-00-AB (VRCO1), 40 mg/kg in 100 mL Normal Saline; VRC-HIVMAB060-00-AB (VRCO1) is a potent HIV-specific monoclonal antibody which was given at Baseline, Week 2, and then every 4 weeks for up to a total of 8 doses
27760|NCT02471326|E1|Reported Event|HIV Positive Subjects|Drug: VRC-HIVMAB060-00-AB (VRCO1), 40 mg/kg in 100 mL Normal Saline; VRC-HIVMAB060-00-AB (VRCO1) is a potent HIV-specific monoclonal antibody which was given at Baseline, Week 2, and then every 4 weeks for up to a total of 8 doses
27761|NCT02471183|B1|Baseline|Selexipag|"The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily.~From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag."
27762|NCT02471183|P1|Participant Flow|Selexipag|"The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily.~From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag."
27763|NCT02471183|O1|Outcome|Selexipag|"The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily.~From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag."
27764|NCT02471183|O1|Outcome|Selexipag|"The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily.~From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag."
27765|NCT02471183|O1|Outcome|Selexipag|"The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily.~From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag."
27766|NCT02471183|O1|Outcome|Selexipag|"The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily.~From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag."
27767|NCT02471183|O1|Outcome|Selexipag|"The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily.~From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag."
27768|NCT02471183|O1|Outcome|Selexipag|"The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily.~From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag."
27769|NCT02471183|O1|Outcome|Selexipag|"The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily.~From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag."
27770|NCT02471183|O1|Outcome|Selexipag|"The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily.~From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag."
27771|NCT02471183|O1|Outcome|Selexipag|"The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily.~From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag."
27772|NCT02471183|O1|Outcome|Selexipag|"The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily.~From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag."
27799|NCT02470429|P1|Participant Flow|SYSTANE HYDRATION|SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
27800|NCT02470429|O2|Outcome|Hyabak 0.15%|Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
27773|NCT02471183|O1|Outcome|Selexipag|"The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily.~From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag."
27774|NCT02471183|O1|Outcome|Selexipag|"The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily.~From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag."
27775|NCT02471183|E1|Reported Event|Selexipag|All subjects who take at least one dose of selexipag. The mean duration of exposure to selexipag was 21.6 weeks
27776|NCT02470949|B1|Baseline|All Study Participants|High Social Status Condition in Monopoly Game and Low Social Status Condition in Monopoly Game
27777|NCT02470949|P2|Participant Flow|High Social Status, Then Low Social Status|High Social Status Condition in Monopoly Game during the first intervention period and Low Social Status Condition in Monopoly Game during the second intervention period (after washout period).
27778|NCT02470949|P1|Participant Flow|Low Social Status, Then High Social Status|Low Social Status Condition in Monopoly Game during the first intervention period and High Social Status Condition in Monopoly Game during the second intervention period (after washout period).
27779|NCT02470949|O2|Outcome|High Social Status|"High Social Status Condition in Monopoly Game~High Social Status: The participants will be randomized to the High Social Status Condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
27780|NCT02470949|O1|Outcome|Low Social Status|"Low Social Status Condition in Monopoly Game.~Low Social Status: The participants will be randomized to the Low Social Status Condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
27781|NCT02470949|O2|Outcome|High Social Status|"High Social Status Condition in Monopoly Game~High Social Status: The participants will be randomized to the High Social Status Condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
27782|NCT02470949|O1|Outcome|Low Social Status|"Low Social Status Condition in Monopoly Game.~Low Social Status: The participants will be randomized to the Low Social Status Condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
27783|NCT02470949|O2|Outcome|High Social Status|"High Social Status Condition in Monopoly Game~Manipulated Social Status: The participants will be randomized to either the Low Social Status Condition or the High Social Status condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
27784|NCT02470949|O1|Outcome|Low Social Status|"Low Social Status Condition in Monopoly Game.~Manipulated Social Status: The participants will be randomized to either the Low Social Status Condition or the High Social Status condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
27785|NCT02470949|E2|Reported Event|High Social Status|"High Social Status Condition in Monopoly Game~Manipulated Social Status: The participants will be randomized to either the Low Social Status Condition or the High Social Status condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
27786|NCT02470949|E1|Reported Event|Low Social Status|"Low Social Status Condition in Monopoly Game.~Manipulated Social Status: The participants will be randomized to either the Low Social Status Condition or the High Social Status condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
27787|NCT02470494|B1|Baseline|Sound Amplification Via EarLens CHD|"Sound amplification provided via the EarLens CHD for subjects with hearing impairment.~Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD."
27788|NCT02470494|P1|Participant Flow|Sound Amplification Via EarLens CHD|"Sound amplification provided via the EarLens CHD for subjects with hearing impairment.~Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD."
27789|NCT02470494|O1|Outcome|Sound Amplification Via EarLens CHD|"Sound amplification provided via the EarLens CHD for subjects with hearing impairment.~Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD."
27790|NCT02470494|O1|Outcome|Sound Amplification Via EarLens CHD|"Sound amplification provided via the EarLens CHD for subjects with hearing impairment.~Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD."
27791|NCT02470494|O1|Outcome|Sound Amplification Via EarLens CHD|"Sound amplification provided via the EarLens CHD for subjects with hearing impairment.~Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD."
27792|NCT02470494|O1|Outcome|Sound Amplification Via EarLens CHD|"Sound amplification provided via the EarLens CHD for subjects with hearing impairment.~Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD."
27793|NCT02470494|O1|Outcome|Sound Amplification Via EarLens CHD|"Sound amplification provided via the EarLens CHD for subjects with hearing impairment.~Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD."
27794|NCT02470494|E1|Reported Event|Sound Amplification Via EarLens CHD|"Sound amplification provided via the EarLens CHD for subjects with hearing impairment.~Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD."
27795|NCT02470429|B3|Baseline|Total|Total of all reporting groups
27796|NCT02470429|B2|Baseline|Hyabak 0.15%|Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
27797|NCT02470429|B1|Baseline|SYSTANE HYDRATION|SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
27801|NCT02470429|O1|Outcome|SYSTANE HYDRATION|SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
27802|NCT02470429|O2|Outcome|Hyabak 0.15%|Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
27803|NCT02470429|O1|Outcome|SYSTANE HYDRATION|SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
27804|NCT02470429|O2|Outcome|Hyabak 0.15%|Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
27805|NCT02470429|O1|Outcome|SYSTANE HYDRATION|SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
27806|NCT02470429|O2|Outcome|Hyabak 0.15%|Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
27807|NCT02470429|O1|Outcome|SYSTANE HYDRATION|SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
27808|NCT02470429|E3|Reported Event|Hyabak 0.15%|All subjects treated with Hyabak 0.15% eye drops
27809|NCT02470429|E2|Reported Event|SYSTANE HYDRATION|All subjects treated with SYSTANE HYDRATION lubricant eye drops
27810|NCT02470429|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
27811|NCT02470403|B6|Baseline|Total|Total of all reporting groups
27812|NCT02470403|B5|Baseline|Part 2: Placebo Three Times Daily|Matching placebo tablets tid before meals.
27813|NCT02470403|B4|Baseline|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
27814|NCT02470403|B3|Baseline|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
27815|NCT02470403|B2|Baseline|Part 1: Placebo Once Daily|Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch.
27816|NCT02470403|B1|Baseline|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
27817|NCT02470403|P5|Participant Flow|Part 2: Placebo Three Times Daily|Matching placebo tablets tid before meals.
27818|NCT02470403|P4|Participant Flow|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
27819|NCT02470403|P3|Participant Flow|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
27820|NCT02470403|P2|Participant Flow|Part 1: Placebo Once Daily|Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch.
27821|NCT02470403|P1|Participant Flow|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
27822|NCT02470403|O2|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
27823|NCT02470403|O1|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
27824|NCT02470403|O2|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
27825|NCT02470403|O1|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
27826|NCT02470403|O2|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
27827|NCT02470403|O1|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
27828|NCT02470403|O2|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
27829|NCT02470403|O1|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
27830|NCT02470403|O2|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
27831|NCT02470403|O1|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
27832|NCT02470403|O2|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
27833|NCT02470403|O1|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
27834|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
27835|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
27836|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
27837|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
27838|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
27839|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
27840|NCT02470403|O2|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
27841|NCT02470403|O1|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
27842|NCT02470403|O3|Outcome|Part 2: Placebo Three Times Daily|Matching placebo tablets tid before meals.
27843|NCT02470403|O2|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
27844|NCT02470403|O1|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
27845|NCT02470403|O4|Outcome|Part 1 and 2 : Pooled Placebo|Placebo subjects were pooled between the 2 parts and were considered a single treatment arm for the analyses
27846|NCT02470403|O3|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
27847|NCT02470403|O2|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
27848|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
27849|NCT02470403|O2|Outcome|Part 1: Placebo Once Daily|Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch.
27850|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
27851|NCT02470403|O2|Outcome|Part 1: Placebo Once Daily|Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch.
27852|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
27853|NCT02470403|E5|Reported Event|Part 2: Placebo Three Times Daily|Matching placebo tablets tid before meals.
27854|NCT02470403|E4|Reported Event|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
27855|NCT02470403|E3|Reported Event|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
27856|NCT02470403|E2|Reported Event|Part 1: Placebo Once Daily|Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch.
27857|NCT02470403|E1|Reported Event|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
27858|NCT02470390|B3|Baseline|Total|Total of all reporting groups
27859|NCT02470390|B2|Baseline|Sublingual Fentanyl First, Then Nasal Fentanyl and IV Fentanyl|"Sublingual Fentanyl, 200 μg, administered as a single spray (100 μL) under the tongue on Study Day 1 per protocol.~Nasal Fentanyl, 200 μg, administered as one 100 μg spray (100 μL) to each nostril; both completed within one minute on Study Day 3 per protocol.~IV Fentanyl, 100 μg in 2 mL administered as an intravenous injection over 1-3 minutes on Study Day 5 per protocol."
27860|NCT02470390|B1|Baseline|Nasal Fentanyl First, Then Sublingual Fentanyl and IV Fentanyl|"Nasal Fentanyl, 200 μg, administered as one 100 μg spray (100 μL) to each nostril; both completed within one minute on Study Day 1 per protocol.~Sublingual Fentanyl, 200 μg, administered as a single spray (100 μL) under the tongue on Study Day 3 per protocol.~IV Fentanyl, 100 μg in 2 mL administered as an intravenous injection over 1-3 minutes on Study Day 5 per protocol."
27861|NCT02470390|P2|Participant Flow|Sublingual Fentanyl First, Then Nasal Fentanyl and IV Fentanyl|"Sublingual Fentanyl, 200 μg, administered as a single spray (100 μL) under the tongue on Study Day 1 per protocol.~Nasal Fentanyl, 200 μg, administered as one 100 μg spray (100 μL) to each nostril; both completed within one minute on Study Day 3 per protocol.~IV Fentanyl, 100 μg in 2 mL administered as an intravenous injection over 1-3 minutes on Study Day 5 per protocol."
27862|NCT02470390|P1|Participant Flow|Nasal Fentanyl First, Then Sublingual Fentanyl and IV Fentanyl|"Nasal Fentanyl, 200 μg, administered as one 100 μg spray (100 μL) to each nostril; both completed within one minute on Study Day 1 per protocol.~Sublingual Fentanyl, 200 μg, administered as a single spray (100 μL) under the tongue on Study Day 3 per protocol.~IV Fentanyl, 100 μg in 2 mL administered as an intravenous injection over 1-3 minutes on Study Day 5 per protocol."
27863|NCT02470390|O3|Outcome|IV Fentanyl|IV Fentanyl, 100 μg in 2 mL administered as an intravenous injection over 1-3 minutes on Study Day 5 per protocol.
27864|NCT02470390|O2|Outcome|Sublingual Fentanyl|Sublingual Fentanyl, 200 μg, administered as a single spray (100 μL) under the tongue on Study Day 1 or 3 per protocol.
27865|NCT02470390|O1|Outcome|Nasal Fentanyl|Nasal Fentanyl, 200 μg, administered as one 100 μg spray (100 μL) to each nostril; both completed within one minute on Study Day 1 or 3 per protocol.
27866|NCT02470390|O3|Outcome|IV Fentanyl|IV Fentanyl, 100 μg in 2 mL administered as an intravenous injection over 1-3 minutes on Study Day 5 per protocol.
27867|NCT02470390|O2|Outcome|Sublingual Fentanyl|Sublingual Fentanyl, 200 μg, administered as a single spray (100 μL) under the tongue on Study Day 1 or 3 per protocol.
27868|NCT02470390|O1|Outcome|Nasal Fentanyl|Nasal Fentanyl, 200 μg, administered as one 100 μg spray (100 μL) to each nostril; both completed within one minute on Study Day 1 or 3 per protocol.
27869|NCT02470390|O3|Outcome|IV Fentanyl|IV Fentanyl, 100 μg in 2 mL administered as an intravenous injection over 1-3 minutes on Study Day 5 per protocol.
27870|NCT02470390|O2|Outcome|Sublingual Fentanyl|Sublingual Fentanyl, 200 μg, administered as a single spray (100 μL) under the tongue on Study Day 1 or 3 per protocol.
27871|NCT02470390|O1|Outcome|Nasal Fentanyl|Nasal Fentanyl, 200 μg, administered as one 100 μg spray (100 μL) to each nostril; both completed within one minute on Study Day 1 or 3 per protocol.
27872|NCT02470390|O3|Outcome|IV Fentanyl|IV Fentanyl, 100 μg in 2 mL administered as an intravenous injection over 1-3 minutes on Study Day 5 per protocol.
27873|NCT02470390|O2|Outcome|Sublingual Fentanyl|Sublingual Fentanyl, 200 μg, administered as a single spray (100 μL) under the tongue on Study Day 1 or 3 per protocol.
27874|NCT02470390|O1|Outcome|Nasal Fentanyl|Nasal Fentanyl, 200 μg, administered as one 100 μg spray (100 μL) to each nostril; both completed within one minute on Study Day 1 or 3 per protocol.
27875|NCT02470390|O3|Outcome|IV Fentanyl|IV Fentanyl, 100 μg in 2 mL administered as an intravenous injection over 1-3 minutes on Study Day 5 per protocol.
27876|NCT02470390|O2|Outcome|Sublingual Fentanyl|Sublingual Fentanyl, 200 μg, administered as a single spray (100 μL) under the tongue on Study Day 1 or 3 per protocol.
27877|NCT02470390|O1|Outcome|Nasal Fentanyl|Nasal Fentanyl, 200 μg, administered as one 100 μg spray (100 μL) to each nostril; both completed within one minute on Study Day 1 or 3 per protocol.
27878|NCT02470390|O2|Outcome|Sublingual Fentanyl|Sublingual Fentanyl, 200 μg, administered as a single spray (100 μL) under the tongue on Study Day 1 or 3 per protocol.
27879|NCT02470390|O1|Outcome|Nasal Fentanyl|Nasal Fentanyl, 200 μg, administered as one 100 μg spray (100 μL) to each nostril; both completed within one minute on Study Day 1 or 3 per protocol.
27880|NCT02470390|O2|Outcome|Sublingual Fentanyl|Sublingual Fentanyl, 200 μg, administered as a single spray (100 μL) under the tongue on Study Day 1 or 3 per protocol.
27881|NCT02470390|O1|Outcome|Nasal Fentanyl|Nasal Fentanyl, 200 μg, administered as one 100 μg spray (100 μL) to each nostril; both completed within one minute on Study Day 1 or 3 per protocol.
27882|NCT02470390|O2|Outcome|Sublingual Fentanyl|Sublingual Fentanyl, 200 μg, administered as a single spray (100 μL) under the tongue on Study Day 1 or 3 per protocol.
27883|NCT02470390|O1|Outcome|Nasal Fentanyl|Nasal Fentanyl, 200 μg, administered as one 100 μg spray (100 μL) to each nostril; both completed within one minute on Study Day 1 or 3 per protocol.
27884|NCT02470390|E3|Reported Event|IV Fentanyl|IV Fentanyl, 100 μg in 2 mL administered as an intravenous injection over 1-3 minutes on Study Day 5 per protocol.
27885|NCT02470390|E2|Reported Event|Sublingual Fentanyl|Sublingual Fentanyl, 200 μg, administered as a single spray (100 μL) under the tongue on Study Day 1 or 3 per protocol.
27886|NCT02470390|E1|Reported Event|Nasal Fentanyl|Nasal Fentanyl, 200 μg, administered as one 100 μg spray (100 μL) to each nostril; both completed within one minute on Study Day 1 or 3 per protocol.
27887|NCT02469961|B3|Baseline|Total|Total of all reporting groups
27888|NCT02469961|B2|Baseline|Propofol|"Participants will receive an interscalene block and be sedated with propofol~Propofol: Participants will receive an interscalene block and be sedated with propofol and compared to sedation with Dexmedetomidine~Interscalene block: Interscalene block is used for the main anesthetic for the case"
27889|NCT02469961|B1|Baseline|Dexmedetomidine|"Participants will receive an interscalene block and be sedated with dexmedetomidine~Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol~Interscalene block: Interscalene block is used for the main anesthetic for the case"
27890|NCT02469961|P2|Participant Flow|Propofol|"Participants will receive an interscalene block and be sedated with propofol~Propofol: Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidme~Interscalene block: Interscalene block is used for the main anesthetic for the case"
27891|NCT02469961|P1|Participant Flow|Dexmedetomidne|"Participants will receive an interscalene block and be sedated with dexmedetomidine~Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol~Interscalene block: Interscalene block is used for the main anesthetic for the case"
27892|NCT02469961|O2|Outcome|Propofol|"Participants will receive an interscalene block and be sedated with propofol~Propofol: Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidine~Interscalene block: Interscalene block is used for the main anesthetic for the case"
27893|NCT02469961|O1|Outcome|Dexmedetomidine|"Participants will receive an interscalene block and be sedated with dexmedetomidine~Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol~Interscalene block: Interscalene block is used for the main anesthetic for the case"
27894|NCT02469961|O2|Outcome|Dexmedetomidine|Patients who received Dexmedetomidine
27895|NCT02469961|O1|Outcome|Propofol|Patients who received Propofol
27896|NCT02469961|O2|Outcome|Propofol|"Participants will receive an interscalene block and be sedated with propofol~Propofol: Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidme~Interscalene block: Interscalene block is used for the main anesthetic for the case"
27897|NCT02469961|O1|Outcome|Dexmedetomidine|"Participants will receive an interscalene block and be sedated with dexmedetomidine~Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol~Interscalene block: Interscalene block is used for the main anesthetic for the case"
27898|NCT02469961|O2|Outcome|Propofol|Number of patients required airway manipulations
27899|NCT02469961|O1|Outcome|Dexmedetomidine|Number of patients required airway manipulation
27900|NCT02469961|E2|Reported Event|Propofol|"Participants will receive an interscalene block and be sedated with propofol~Propofol: Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidme~Interscalene block: Interscalene block is used for the main anesthetic for the case"
27901|NCT02469961|E1|Reported Event|Dexmedetomidine|"Participants will receive an interscalene block and be sedated with dexmedetomidine~Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol~Interscalene block: Interscalene block is used for the main anesthetic for the case"
27902|NCT02469701|B1|Baseline|Nivolumab With Ablation|"3mg/kg IV over 60 minutes on Day 1 +/- 3 days every 2 weeks until progression for a maximum of 2 years.~Either cryoablation or thermal ablation may be performed as per standard institutional policies~nivolumab and ablation"
27903|NCT02469701|P1|Participant Flow|Nivolumab With Ablation|"3mg/kg IV over 60 minutes on Day 1 +/- 3 days every 2 weeks until progression for a maximum of 2 years.~Either cryoablation or thermal ablation may be performed as per standard institutional policies~nivolumab and ablation~As of amendment # 7 submitted to sites November 17, 2017, the dosing for Nivolumab per the FDA guidance was amended to a flat dose of 240mg IV Q2 weeks. As of amendment #8 sent to sites February 22, 2017 the dose of Nivolumab was updated to 3 mg/kg with a maximum dose of 240 mg for patients with weights that would correlate to exceed that dose instead of a flat dose secondary to the standard institutional practice and the FDA guidance ."
27904|NCT02469701|O1|Outcome|Nivolumab With Ablation|"3mg/kg IV over 60 minutes on Day 1 +/- 3 days every 2 weeks until progression for a maximum of 2 years.~Either cryoablation or thermal ablation may be performed as per standard institutional policies~nivolumab and ablation"
27905|NCT02469701|E1|Reported Event|Nivolumab With Ablation|"3mg/kg IV over 60 minutes on Day 1 +/- 3 days every 2 weeks until progression for a maximum of 2 years.~Either cryoablation or thermal ablation may be performed as per standard institutional policies~nivolumab and ablation~As of amendment # 7 submitted to sites November 17, 2017, the dosing for Nivolumab per the FDA guidance was amended to a flat dose of 240mg IV Q2 weeks. As of amendment #8 sent to sites February 22, 2017 the dose of Nivolumab was updated to 3 mg/kg with a maximum dose of 240 mg for patients with weights that would correlate to exceed that dose instead of a flat dose secondary to the standard institutional practice and the FDA guidance ."
27906|NCT02469597|B3|Baseline|Total|Total of all reporting groups
27907|NCT02469597|B2|Baseline|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
27908|NCT02469597|B1|Baseline|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
27909|NCT02469597|P2|Participant Flow|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
27910|NCT02469597|P1|Participant Flow|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
27911|NCT02469597|O2|Outcome|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
27912|NCT02469597|O1|Outcome|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
27913|NCT02469597|O2|Outcome|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
27914|NCT02469597|O1|Outcome|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
27915|NCT02469597|O2|Outcome|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
27916|NCT02469597|O1|Outcome|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
27917|NCT02469597|O2|Outcome|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
27918|NCT02469597|O1|Outcome|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
27919|NCT02469597|O2|Outcome|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
27920|NCT02469597|O1|Outcome|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
27921|NCT02469597|O2|Outcome|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
27922|NCT02469597|O1|Outcome|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
27923|NCT02469597|E2|Reported Event|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
27924|NCT02469597|E1|Reported Event|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
27925|NCT02469415|B1|Baseline|Pacritinib + Azacitidine or Decitabine|"Pacritinib: Part 1: Pacritinib 200 mg taken by mouth twice daily.~Part 2: Pacritinib dose decreased to 200 mg in the morning and 100 mg in the evening for the first cycle of combined therapy. If no toxicity is observed in first cycle of combined therapy, Pacritinib dose may be increased to 200 mg twice a day on subsequent cycles of combined therapy.~5-azacitidine: Part 2 Starting Dose of 5-azacitidine: 75 mg/m2 by vein on Days 1 - 5 of Cycles 5 and beyond.~Decitabine: Part 2 Starting Dose of Decitabine: 20 mg/m2 by vein on on Days 1 - 7 of Cycles 5 and beyond."
27926|NCT02469415|P1|Participant Flow|Pacritinib + Azacitidine or Decitabine|"Pacritinib: Part 1: Pacritinib 200 mg taken by mouth twice daily.~Part 2: Pacritinib dose decreased to 200 mg in the morning and 100 mg in the evening for the first cycle of combined therapy. If no toxicity is observed in first cycle of combined therapy, Pacritinib dose may be increased to 200 mg twice a day on subsequent cycles of combined t"
27927|NCT02469415|O1|Outcome|Pacritinib + Azacitidine or Decitabine|"Pacritinib: Part 1: Pacritinib 200 mg taken by mouth twice daily.~Part 2: Pacritinib dose decreased to 200 mg in the morning and 100 mg in the evening for the first cycle of combined therapy. If no toxicity is observed in first cycle of combined therapy, Pacritinib dose may be increased to 200 mg twice a day on subsequent cycles of combined t"
27928|NCT02469415|E1|Reported Event|Pacritinib + Azacitidine or Decitabine|"Pacritinib: Part 1: Pacritinib 200 mg taken by mouth twice daily.~Part 2: Pacritinib dose decreased to 200 mg in the morning and 100 mg in the evening for the first cycle of combined therapy. If no toxicity is observed in first cycle of combined therapy, Pacritinib dose may be increased to 200 mg twice a day on subsequent cycles of combined t"
27929|NCT02469298|B5|Baseline|Total|Total of all reporting groups
27930|NCT02469298|B4|Baseline|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27931|NCT02469298|B3|Baseline|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27932|NCT02469298|B2|Baseline|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27933|NCT02469298|B1|Baseline|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27934|NCT02469298|P4|Participant Flow|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27935|NCT02469298|P3|Participant Flow|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27936|NCT02469298|P2|Participant Flow|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27937|NCT02469298|P1|Participant Flow|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27938|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received Danirixin matching placebo twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
27939|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
27940|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received Danirixin matching placebo (PBO [DNX]) twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days
27941|NCT02469298|O1|Outcome|Danirixin (DNX) 75 Milligram (mg)|Participants received 75 mg oral Danirixin twice daily with Oseltamivir matching placebo (PBO [OSV]) twice daily for a total of ten doses over five days
27942|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received Danirixin matching placebo twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
27943|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
27944|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received Danirixin matching placebo (PBO [DNX]) twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days
27945|NCT02469298|O1|Outcome|Danirixin (DNX) 75 Milligram (mg)|Participants received 75 mg oral Danirixin twice daily with Oseltamivir matching placebo (PBO [OSV]) twice daily for a total of ten doses over five days
27946|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received Danirixin matching placebo twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
27947|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
27948|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received Danirixin matching placebo (PBO [DNX]) twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days
27949|NCT02469298|O1|Outcome|Danirixin (DNX) 75 Milligram (mg)|Participants received 75 mg oral Danirixin twice daily with Oseltamivir matching placebo (PBO [OSV]) twice daily for a total of ten doses over five days
27950|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27951|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27952|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27953|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27954|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27955|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27956|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27957|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27958|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27959|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27960|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27961|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27962|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27963|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27964|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27965|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27966|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27967|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27968|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27969|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27970|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27971|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27972|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27973|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27974|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27975|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27976|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27977|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27978|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27979|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27980|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27981|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27982|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27983|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27984|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27985|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27986|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27987|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27988|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27989|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27990|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27991|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27992|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27993|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27994|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27995|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27996|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27997|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
27998|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
27999|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28000|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28001|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28002|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28003|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28004|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28005|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28006|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28007|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28008|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28009|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28010|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28011|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28012|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28013|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28014|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28015|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28016|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28017|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28018|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28019|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28020|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28021|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28022|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28023|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28024|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28025|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28026|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28027|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28028|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28029|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28030|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28031|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28032|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28033|NCT02469298|O1|Outcome|Danirixin (DNX) 75 Milligram (mg)|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28034|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28035|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28036|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28037|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28038|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28039|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28040|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28041|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28042|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28043|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28044|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28045|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28046|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28047|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28048|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28049|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28050|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28051|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28052|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28053|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28054|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28055|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28056|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28057|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28058|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28059|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28060|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28061|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28062|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received Danirixin matching placebo twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
28063|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
28064|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received Danirixin matching placebo (PBO [DNX]) twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days
28065|NCT02469298|O1|Outcome|Danirixin (DNX) 75 Milligram (mg)|Participants received 75 mg oral Danirixin twice daily with Oseltamivir matching placebo (PBO [OSV]) twice daily for a total of ten doses over five days
28066|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28067|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
28068|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28069|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
28070|NCT02469298|E4|Reported Event|Oseltamivir (OSV) 75 mg|Participants received Danirixin matching placebo twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
28071|NCT02469298|E3|Reported Event|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
28072|NCT02469298|E2|Reported Event|Placebo (PBO)|Participants received Danirixin matching placebo (PBO [DNX]) twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days
28073|NCT02469298|E1|Reported Event|Danirixin (DNX) 75 Milligram (mg)|Participants received 75 mg oral Danirixin twice daily with Oseltamivir matching placebo (PBO [OSV]) twice daily for a total of ten doses over five days
28074|NCT02469168|B3|Baseline|Total|Total of all reporting groups
28075|NCT02469168|B2|Baseline|Control|"Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B~Control: Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix"
28076|NCT02469168|B1|Baseline|ReCell|"Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B~Recell: ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix"
28077|NCT02469168|P2|Participant Flow|Control|"Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B~Control: Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix"
28078|NCT02469168|P1|Participant Flow|ReCell|"Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B~Recell: ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix"
28079|NCT02469168|O2|Outcome|Control|"Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B~Control: Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix"
28118|NCT02468583|E1|Reported Event|FX006 32 mg|FX006: Single 5 mL IA injection
28080|NCT02469168|O1|Outcome|ReCell|"Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B~Recell: ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix"
28081|NCT02469168|O2|Outcome|Control|"Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B~Control: Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix"
28082|NCT02469168|O1|Outcome|ReCell|"Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B~Recell: ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix"
28083|NCT02469168|E2|Reported Event|Control|"Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B~Control: Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix"
28084|NCT02469168|E1|Reported Event|ReCell|"Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B~Recell: ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix"
28085|NCT02469116|B1|Baseline|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
28086|NCT02469116|P1|Participant Flow|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
28087|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
28088|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
28089|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
28090|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
28091|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
28092|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
28093|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
28094|NCT02469116|E1|Reported Event|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
28095|NCT02468700|B3|Baseline|Total|Total of all reporting groups
28096|NCT02468700|B2|Baseline|Placebo Vehicle|PV (placebo drug delivery vehicle)
28097|NCT02468700|B1|Baseline|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
28098|NCT02468700|P2|Participant Flow|Placebo Vehicle|PV (placebo drug delivery vehicle)
28099|NCT02468700|P1|Participant Flow|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
28100|NCT02468700|O2|Outcome|Placebo Vehicle|PV (placebo drug delivery vehicle)
28101|NCT02468700|O1|Outcome|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
28102|NCT02468700|O2|Outcome|Placebo Vehicle|PV (placebo drug delivery vehicle)
28103|NCT02468700|O1|Outcome|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
28104|NCT02468700|O2|Outcome|Placebo Vehicle|PV (placebo drug delivery vehicle)
28105|NCT02468700|O1|Outcome|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
28106|NCT02468700|O2|Outcome|Placebo Vehicle|PV (placebo drug delivery vehicle)
28107|NCT02468700|O1|Outcome|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
28108|NCT02468700|E2|Reported Event|Placebo Vehicle|PV (placebo drug delivery vehicle)
28109|NCT02468700|E1|Reported Event|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
28110|NCT02468583|B3|Baseline|Total|Total of all reporting groups
28111|NCT02468583|B2|Baseline|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
28112|NCT02468583|B1|Baseline|FX006 32 mg|FX006: Single 5 mL IA injection
28113|NCT02468583|P2|Participant Flow|TCA IR 40 mg|3 subjects received TCA IR 40 mg as a single 1 mL IA injection
28114|NCT02468583|P1|Participant Flow|FX006 32 mg|3 subjects received FX006 32 mg as a single 5 mL IA injection
28115|NCT02468583|O2|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
28116|NCT02468583|O1|Outcome|FX006 32 mg|FX006: Single 5 mL IA injection
28117|NCT02468583|E2|Reported Event|TCA IR 40 mg|TCA IR: Single 3 mL IA injection
28129|NCT02468154|B2|Baseline|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane~standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
28130|NCT02468154|B1|Baseline|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.~custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
28131|NCT02468154|P2|Participant Flow|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane~standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
28132|NCT02468154|P1|Participant Flow|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.~custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
28133|NCT02468154|O2|Outcome|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane~standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
28134|NCT02468154|O1|Outcome|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.~custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
28135|NCT02468154|O2|Outcome|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane~standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
28136|NCT02468154|O1|Outcome|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.~custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
28137|NCT02468154|O2|Outcome|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane~standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
28138|NCT02468154|O1|Outcome|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.~custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
28139|NCT02468154|O2|Outcome|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane~standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
28140|NCT02468154|O1|Outcome|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.~custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
28141|NCT02468154|E2|Reported Event|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane~standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
28142|NCT02468154|E1|Reported Event|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.~custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
28143|NCT02467777|B3|Baseline|Total|Total of all reporting groups
28144|NCT02467777|B2|Baseline|Conductive Warming|"VitaHeat~VitaHeat"
28145|NCT02467777|B1|Baseline|Forced Air|"Bair Hugger~Bair Hugger"
28146|NCT02467777|P2|Participant Flow|Conductive Warming|"VitaHeat~VitaHeat"
28147|NCT02467777|P1|Participant Flow|Forced Air|"Bair Hugger~Bair Hugger"
28148|NCT02467777|O2|Outcome|Conductive Warming|"VitaHeat~VitaHeat"
28149|NCT02467777|O1|Outcome|Forced Air|"Bair Hugger~Bair Hugger"
28150|NCT02467777|E2|Reported Event|Conductive Warming|"VitaHeat~VitaHeat"
28151|NCT02467777|E1|Reported Event|Forced Air|"Bair Hugger~Bair Hugger"
28152|NCT02467491|B1|Baseline|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
28193|NCT02466425|B1|Baseline|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
28153|NCT02467491|P1|Participant Flow|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
28154|NCT02467491|O1|Outcome|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
28155|NCT02467491|O1|Outcome|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
28156|NCT02467491|O1|Outcome|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
28157|NCT02467491|O1|Outcome|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
28158|NCT02467491|O1|Outcome|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
28159|NCT02467491|O1|Outcome|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
28160|NCT02467491|E1|Reported Event|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
28161|NCT02467075|B3|Baseline|Total|Total of all reporting groups
28162|NCT02467075|B2|Baseline|Placebo (Normal Saline)|"Subjects scheduled for a standard of care CT will be randomized to receive weight-based normal saline instead of contrast material with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT.~Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan"
28163|NCT02467075|B1|Baseline|Iopamidol 300 (Contrast)|"Subjects scheduled for a clinical CT will be randomized to receive weight-based low-osmolality iodinated contrast with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT.~Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan"
28164|NCT02467075|P2|Participant Flow|Placebo (Normal Saline)|"Subjects scheduled for a clinical CT will be randomized to receive normal saline instead of contrast material with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT. The fluids are given to placebo patients in order to minimize any differences in treatment between the treatment and placebo groups.~Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan"
28165|NCT02467075|P1|Participant Flow|Iopamidol 300 (Contrast)|"Subjects scheduled for a clinical CT will be randomized to receive weight-based low-osmolality iodinated contrast with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT. The function of the fluids is to minimize the effect of the contrast on their creatinine level.~Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan"
28166|NCT02467075|O2|Outcome|Placebo (Normal Saline)|"Subjects scheduled for a standard of care CT will be randomized to receive weight-based normal saline instead of contrast material with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT.~Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan"
28192|NCT02466425|B2|Baseline|SHP465|Participants received SHP465 capsule (12.5 mg during dose optimization and 25 mg during the dose maintenance phase) orally once daily for 4 weeks.
28167|NCT02467075|O1|Outcome|Iopamidol 300 (Contrast)|"Subjects scheduled for a clinical CT will be randomized to receive weight-based low-osmolality iodinated contrast with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT.~Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan"
28168|NCT02467075|O2|Outcome|Placebo (Normal Saline)|"Subjects scheduled for a standard of care CT will be randomized to receive weight-based normal saline instead of contrast material with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT.~Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan"
28169|NCT02467075|O1|Outcome|Iopamidol 300 (Contrast)|"Subjects scheduled for a clinical CT will be randomized to receive weight-based low-osmolality iodinated contrast with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT.~Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan"
28170|NCT02467075|O2|Outcome|Placebo (Normal Saline)|"Subjects scheduled for a clinical CT were randomized to receive weight-based normal saline instead of contrast material with the CT.~All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT.~Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan"
28171|NCT02467075|O1|Outcome|Iopamidol 300 (Contrast)|"Subjects scheduled for a clinical CT were randomized to receive weight-based low-osmolality iodinated contrast with the CT.~All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT.~Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan"
28172|NCT02467075|O2|Outcome|Placebo (Normal Saline)|"Subjects scheduled for a clinical CT were randomized to receive weight-based normal saline instead of contrast material with the CT.~All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT.~Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan"
28173|NCT02467075|O1|Outcome|Iopamidol 300 (Contrast)|"Subjects scheduled for a clinical CT were randomized to receive weight-based low-osmolality iodinated contrast with the CT.~All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT.~Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan"
28174|NCT02467075|O2|Outcome|Placebo (Normal Saline)|"Subjects scheduled for a clinical CT were randomized to receive weight-based normal saline instead of contrast material with the CT.~All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT.~Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan"
28175|NCT02467075|O1|Outcome|Iopamidol 300 (Contrast)|"Subjects scheduled for a clinical CT were randomized to receive weight-based low-osmolality iodinated contrast with the CT.~All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT.~Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan"
28176|NCT02467075|O2|Outcome|Placebo (Normal Saline)|"Subjects scheduled for a standard of care CT will be randomized to receive weight-based normal saline instead of contrast material with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT.~Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan"
28177|NCT02467075|O1|Outcome|Iopamidol 300 (Contrast)|"Subjects scheduled for a clinical CT will be randomized to receive weight-based low-osmolality iodinated contrast with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT.~Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan"
28178|NCT02467075|E2|Reported Event|Placebo (Normal Saline)|"Subjects scheduled for a clinical CT were randomized to receive weight-based normal saline instead of contrast material with the CT.~All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT.~Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan"
28179|NCT02467075|E1|Reported Event|Iopamidol 300 (Contrast)|"Subjects scheduled for a clinical CT were randomized to receive weight-based low-osmolality iodinated contrast with the CT.~All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT.~Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan"
28180|NCT02466659|B3|Baseline|Total|Total of all reporting groups
28181|NCT02466659|B2|Baseline|Observation|To observe as one kind of standard care for IXT.
28182|NCT02466659|B1|Baseline|CIAO Therapy|"Intervention with wearing 3-hour daily CIAO therapy glasses~CIAO therapy Amblyz glasses: 3-hour CIAO Therapy Amblyz glasses"
28183|NCT02466659|P2|Participant Flow|Observation|To observe as one kind of standard care for IXT.
28184|NCT02466659|P1|Participant Flow|CIAO Therapy|"Intervention with wearing 3-hour daily CIAO therapy glasses~CIAO therapy Amblyz glasses: 3-hour CIAO Therapy Amblyz glasses"
28185|NCT02466659|O2|Outcome|Observation|To observe as one kind of standard care for IXT.
28186|NCT02466659|O1|Outcome|CIAO Therapy|"Intervention with wearing 3-hour daily CIAO therapy glasses~CIAO therapy Amblyz glasses: 3-hour CIAO Therapy Amblyz glasses"
28187|NCT02466659|O2|Outcome|Observation|To observe as one kind of standard care for IXT.
28188|NCT02466659|O1|Outcome|CIAO Therapy|"Intervention with wearing 3-hour daily CIAO therapy glasses~CIAO therapy Amblyz glasses: 3-hour CIAO Therapy Amblyz glasses"
28189|NCT02466659|E2|Reported Event|Observation|To observe as one kind of standard care for IXT.
28190|NCT02466659|E1|Reported Event|CIAO Therapy|"Intervention with wearing 3-hour daily CIAO therapy glasses~CIAO therapy Amblyz glasses: 3-hour CIAO Therapy Amblyz glasses"
28191|NCT02466425|B3|Baseline|Total|Total of all reporting groups
28194|NCT02466425|P2|Participant Flow|SHP465|Participants received SHP465 capsule (12.5 milligram [mg] during dose optimization and 25 mg during the dose maintenance phase) orally once daily for 4 weeks.
28195|NCT02466425|P1|Participant Flow|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
28196|NCT02466425|O2|Outcome|SHP465|Participants received SHP465 capsule (12.5 mg during dose optimization and 25 mg during the dose maintenance phase) orally once daily for 4 weeks.
28197|NCT02466425|O1|Outcome|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
28198|NCT02466425|O2|Outcome|SHP465|Participants received SHP465 capsule (12.5 mg during dose optimization and 25 mg during the dose maintenance phase) orally once daily for 4 weeks.
28199|NCT02466425|O1|Outcome|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
28200|NCT02466425|E2|Reported Event|SHP465|Participants received SHP465 capsule (12.5 mg during dose optimization and 25 mg during dose maintenance phase) orally once daily for 4 weeks.
28201|NCT02466425|E1|Reported Event|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
28202|NCT02466412|B3|Baseline|Total|Total of all reporting groups
28203|NCT02466412|B2|Baseline|mCC Then CHTP 1.1 M|"Each subject will follow the below study design:~Day -1 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mCC)~Day 2 = Wash-out~Day 3 = 2nd intervention (single product use of CHTP 1.1 M)."
28204|NCT02466412|B1|Baseline|CHTP 1.1 M Then mCC|"Each subject will follow the below study design:~Day -1 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of CHTP 1.1 M)~Day 2 = Wash-out~Day 3 = 2nd intervention (single product use of mCC)."
28205|NCT02466412|P2|Participant Flow|mCC Then CHTP 1.1 M|"Each subject will follow the below study design:~Day -1 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mCC)~Day 2 = Wash-out~Day 3 = 2nd intervention (single product use of CHTP 1.1 M)."
28206|NCT02466412|P1|Participant Flow|CHTP 1.1 M Then mCC|"Each subject will follow the below study design:~Day -1 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of CHTP 1.1 M)~Day 2 = Wash-out~Day 3 = 2nd intervention (single product use of mCC)."
28207|NCT02466412|O2|Outcome|Menthol Cigarette (mCC)|The geometric least square mean presented below takes into consideration the data of all the subjects included in the PK population after single use of mCC.
28208|NCT02466412|O1|Outcome|CHTP 1.1 M|The geometric least square mean presented below takes into consideration the data of all the subjects included in the PK population after single use of CHTP 1.1 M.
28209|NCT02466412|O2|Outcome|Menthol Cigarette (mCC)|The geometric least square mean presented below takes into consideration the data of all the subjects included in the PK population after single use of mCC.
28210|NCT02466412|O1|Outcome|CHTP 1.1 M|The geometric least square mean presented below takes into consideration the data of all the subjects included in the PK population after single use of CHTP 1.1 M.
28211|NCT02466412|E3|Reported Event|Enrolled But Not Randomized|Subjects who tried the CHTP 1.1 M at Admission but were not randomized in 1 of the 2 sequences as they were back-up subjects
28212|NCT02466412|E2|Reported Event|mCC Then CHTP 1.1 M|"Each subject will follow the below study design:~Day -1 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mCC)~Day 2 = Wash-out~Day 3 = 2nd intervention (single product use of CHTP 1.1 M)."
28213|NCT02466412|E1|Reported Event|CHTP 1.1 M Then mCC|"Each subject will follow the below study design:~Day -1 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of CHTP 1.1 M)~Day 2 = Wash-out~Day 3 = 2nd intervention (single product use of mCC)."
28214|NCT02465866|B1|Baseline|Overall Subjects|
28215|NCT02465866|P4|Participant Flow|Sequence 4: DACB|"Treatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition~Treatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition~Treatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition~Treatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition~Dosing in 4 study periods was separated by a 14-day washout period"
28216|NCT02465866|P3|Participant Flow|Sequence 3: CDBA|"Treatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition~Treatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition~Treatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition~Treatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition~Dosing in 4 study periods was separated by a 14-day washout period"
28217|NCT02465866|P2|Participant Flow|Sequence 2: BCAD|"Treatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition~Treatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition~Treatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition~Treatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition~Dosing in 4 study periods was separated by a 14-day washout period"
28218|NCT02465866|P1|Participant Flow|Sequence 1: ABDC|"Treatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition~Treatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition~Treatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition~Treatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition~Dosing in 4 study periods was separated by a 14-day washout period"
28219|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
28220|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
28221|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
28222|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
28223|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
28224|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
28225|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
28226|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
28227|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
28228|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
28229|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
28230|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
28231|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
28232|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
28233|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
28234|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
28235|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
28236|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
28237|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
28238|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
28239|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
28240|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
28241|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
28242|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
28243|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
28244|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
28245|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
28246|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
28247|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
28248|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
28249|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
28250|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
28251|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
28252|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
28253|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
28254|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
28255|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
28256|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
28257|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
28258|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
28259|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
28260|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
28261|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
28262|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
28263|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
28264|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
28265|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
28266|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
28267|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
28268|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
28269|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
28270|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
28271|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
28272|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
28273|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
28274|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
28275|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
28276|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
28277|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
28278|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
28279|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
28280|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
28281|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
28282|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
28283|NCT02465866|E4|Reported Event|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
28284|NCT02465866|E3|Reported Event|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
28285|NCT02465866|E2|Reported Event|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
28286|NCT02465866|E1|Reported Event|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
28287|NCT02465632|B4|Baseline|Total|Total of all reporting groups
28288|NCT02465632|B3|Baseline|Placebo|Placebo: Placebo topical gel
28289|NCT02465632|B2|Baseline|Reference|Reference: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%
28290|NCT02465632|B1|Baseline|Test|Test: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
28291|NCT02465632|P3|Participant Flow|Placebo Topical Gel|Placebo: A thin layer of gel was applied to the entire affected areas on the face twice a day.
28292|NCT02465632|P2|Participant Flow|BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%|Reference: A thin layer of gel was applied to the entire affected areas on the face twice a day.
28293|NCT02465632|P1|Participant Flow|Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel|Test: A thin layer of gel was applied to the entire affected areas on the face twice a day.
28294|NCT02465632|O3|Outcome|Placebo|Placebo: Placebo Topical Gel
28295|NCT02465632|O2|Outcome|Reference|BenzaClin® Topical Gel: Clindamycin and Benzoyl Peroxide Gel, 1%/5%
28296|NCT02465632|O1|Outcome|Test|Clindamycin and Benzoyl Peroxide Gel, 1%/5%
28297|NCT02465632|O3|Outcome|Placebo|Placebo: Placebo topical gel
28298|NCT02465632|O2|Outcome|Reference|BenzaClin® Topical Gel: Clindamycin and Benzoyl Peroxide Gel, 1%/5%
28299|NCT02465632|O1|Outcome|Test|Clindamycin and Benzoyl Peroxide Gel, 1%/5%
28300|NCT02465632|E3|Reported Event|Placebo|Placebo topical gel
28301|NCT02465632|E2|Reported Event|Reference|BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%
28302|NCT02465632|E1|Reported Event|Test|Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
28303|NCT02465489|B1|Baseline|Healthy Volunteers|"Subjects were randomized to receive five treatments in different orders:~deferiprone ER tablets under fasting conditions~deferiprone ER tablets under fed conditions~deferiprone ER tablets administered as half-tablets under fed conditions~Ferriprox IR tablets under fasting conditions~Ferriprox IR tablets under fed conditions"
28304|NCT02465489|P1|Participant Flow|Healthy Volunteers|"Subjects were randomized to receive the following five treatments in different orders, with a 7-day washout period between treatments::~A: Deferiprone ER tablets under fasting conditions B: Deferiprone ER tablets under fed conditions C: Deferiprone ER tablets administered as half-tablets under fed conditions D: Ferriprox IR tablets under fasting conditions E: Ferriprox IR tablets under fed conditions~The sequences were as follows;~Sequence 1 (n=4): A-B-E-C-D~Sequence 2 (n=4): B-C-A-D-E~Sequence 3 (n=4): C-D-B-E-A~Sequence 4 (n=4): D-E-C-A-B~Sequence 5 (n=4): E-A-D-B-C"
28305|NCT02465489|O5|Outcome|Immediate Release, Fed Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
28306|NCT02465489|O4|Outcome|Immediate Release, Fasting Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
28307|NCT02465489|O3|Outcome|Extended Release Half-tablets, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
28308|NCT02465489|O2|Outcome|Extended Release, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
28309|NCT02465489|O1|Outcome|Extended Release, Fasting Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
28310|NCT02465489|O5|Outcome|Immediate Release, Fed Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
28311|NCT02465489|O4|Outcome|Immediate Release, Fasting Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
28312|NCT02465489|O3|Outcome|Extended Release Half-tablets, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
28313|NCT02465489|O2|Outcome|Extended Release, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
28314|NCT02465489|O1|Outcome|Extended Release, Fasting Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
28315|NCT02465489|O5|Outcome|Immediate Release, Fed Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
28316|NCT02465489|O4|Outcome|Immediate Release, Fasting Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
28317|NCT02465489|O3|Outcome|Extended Release Half-tablets, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
28318|NCT02465489|O2|Outcome|Extended Release, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
28319|NCT02465489|O1|Outcome|Extended Release, Fasting Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
28320|NCT02465489|O5|Outcome|Immediate Release, Fed Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
28321|NCT02465489|O4|Outcome|Immediate Release, Fasting Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
28322|NCT02465489|O3|Outcome|Extended Release Half-tablets, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
28323|NCT02465489|O2|Outcome|Extended Release, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
28324|NCT02465489|O1|Outcome|Extended Release, Fasting Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
28325|NCT02465489|E5|Reported Event|Immediate Release, Fed Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
28326|NCT02465489|E4|Reported Event|Immediate Release, Fasting Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
28327|NCT02465489|E3|Reported Event|Extended Release Half-tablets, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
28328|NCT02465489|E2|Reported Event|Extended Release, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
28329|NCT02465489|E1|Reported Event|Extended Release, Fasting Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
28330|NCT02465463|B3|Baseline|Total|Total of all reporting groups
28331|NCT02465463|B2|Baseline|Control|Patients in the non-interventional group will not receive a FMT but will be followed over the course of 6 months to assess for recurrence of C.difficile.
28368|NCT02465450|O3|Outcome|Placebo QD|Placebo: Subjects received placebo on Days 1 - 28.
28369|NCT02465450|O2|Outcome|JBT-101 5 mg QD|JBT-101: 5 mg once a day on Days 1-28.
28332|NCT02465463|B1|Baseline|FMT Arm|"Patients in the experimental arm with undergo a fecal microbiota transplant (FMT) after finishing a course of antibiotics.~Fecal microbiota transplant (FMT): 250 mL of donor stool will be infused into the colon by flexible sigmoidoscopy~flexible sigmoidoscopy"
28333|NCT02465463|P2|Participant Flow|Control|Patients in the non-interventional group did not receive a FMT but were followed over the course of 6 months to assess for recurrence of C.difficile.
28334|NCT02465463|P1|Participant Flow|FMT Arm|"Patients in the experimental arm underwent a fecal microbiota transplant (FMT) after finishing a course of antibiotics.~Fecal microbiota transplant (FMT): 250 mL of donor stool was infused into the colon by flexible sigmoidoscopy~flexible sigmoidoscopy"
28335|NCT02465463|O2|Outcome|Control|Patients in the non-interventional group will not receive a FMT but will be followed over the course of 6 months to assess for recurrence of C.difficile.
28336|NCT02465463|O1|Outcome|FMT Arm|"Patients in the experimental arm with undergo a fecal microbiota transplant (FMT) after finishing a course of antibiotics.~Fecal microbiota transplant (FMT): 250 mL of donor stool will be infused into the colon by flexible sigmoidoscopy~flexible sigmoidoscopy"
28337|NCT02465463|O2|Outcome|Control|Patients in the non-interventional group will not receive a FMT but will be followed over the course of 6 months to assess for recurrence of C.difficile.
28338|NCT02465463|O1|Outcome|FMT Arm|"Patients in the experimental arm with undergo a fecal microbiota transplant (FMT) after finishing a course of antibiotics.~Fecal microbiota transplant (FMT): 250 mL of donor stool will be infused into the colon by flexible sigmoidoscopy~flexible sigmoidoscopy"
28339|NCT02465463|O2|Outcome|Control|Patients in the non-interventional group will not receive a FMT but will be followed over the course of 6 months to assess for recurrence of C.difficile.
28340|NCT02465463|O1|Outcome|FMT Arm|"Patients in the experimental arm with undergo a fecal microbiota transplant (FMT) after finishing a course of antibiotics.~Fecal microbiota transplant (FMT): 250 mL of donor stool will be infused into the colon by flexible sigmoidoscopy~flexible sigmoidoscopy"
28341|NCT02465463|O2|Outcome|Control|Patients in the non-interventional group will not receive a FMT but will be followed over the course of 6 months to assess for recurrence of C.difficile.
28342|NCT02465463|O1|Outcome|FMT Arm|"Patients in the experimental arm with undergo a fecal microbiota transplant (FMT) after finishing a course of antibiotics.~Fecal microbiota transplant (FMT): 250 mL of donor stool will be infused into the colon by flexible sigmoidoscopy~flexible sigmoidoscopy"
28343|NCT02465463|O2|Outcome|Control|Patients in the non-interventional group will not receive a FMT but will be followed over the course of 6 months to assess for recurrence of C.difficile.
28344|NCT02465463|O1|Outcome|FMT Arm|"Patients in the experimental arm with undergo a fecal microbiota transplant (FMT) after finishing a course of antibiotics.~Fecal microbiota transplant (FMT): 250 mL of donor stool will be infused into the colon by flexible sigmoidoscopy~flexible sigmoidoscopy"
28345|NCT02465463|O2|Outcome|Control|Patients in the non-interventional group will not receive a FMT but will be followed over the course of 6 months to assess for recurrence of C.difficile.
28346|NCT02465463|O1|Outcome|FMT Arm|"Patients in the experimental arm will undergo a fecal microbiota transplant (FMT) after finishing a course of antibiotics.~Fecal microbiota transplant (FMT): 250 mL of donor stool will be infused into the colon by flexible sigmoidoscopy~flexible sigmoidoscopy"
28347|NCT02465463|E2|Reported Event|Control|Patients in the non-interventional group will not receive a FMT but will be followed over the course of 6 months to assess for recurrence of C.difficile.
28348|NCT02465463|E1|Reported Event|FMT Arm|"Patients in the experimental arm with undergo a fecal microbiota transplant (FMT) after finishing a course of antibiotics.~Fecal microbiota transplant (FMT): 250 mL of donor stool will be infused into the colon by flexible sigmoidoscopy~flexible sigmoidoscopy"
28349|NCT02465450|B4|Baseline|Total|Total of all reporting groups
28350|NCT02465450|B3|Baseline|Placebo QD,20 mg QD, 20 mg BID, or Placebo BID|Placebo: Subjects received placebo on Days 1 - 28 and either 20 mg QD, 20 mg BID, or Placebo on Days 29-84.
28351|NCT02465450|B2|Baseline|JBT-101 5 mg QD,20 mg QD, or 20 mg BID|JBT-101: 5 mg once a day on Days 1-28 and either 20 mg QD or 20 mg BID on Days 29-84.
28352|NCT02465450|B1|Baseline|JBT101 1 mg QD, 20 mg QD, or 20 mg BID|JBT-101: 1 mg once a day on Days 1-28 and either 20 mg QD or 20 mg BID on Days 29-84.
28353|NCT02465450|P6|Participant Flow|Placebo BID|"Placebo administered twice daily.~Subjects in this analysis group received placebo on Days 1 - 28."
28354|NCT02465450|P5|Participant Flow|JBT-101 20 mg BID|"JBT-101: 20 mg twice a day on Days 29 - 84.~JBT-101: Subjects in this analysis group could have received 1 mg, 5 mg, or placebo during Days 1 - 28."
28355|NCT02465450|P4|Participant Flow|JBT-101 20 mg QD|"JBT-101: 20 mg once a day on Days 29 - 84.~JBT-101: Subjects in this analysis group could have received 1 mg, 5 mg, or placebo during Days 1 - 28."
28356|NCT02465450|P3|Participant Flow|Placebo QD|Placebo: Subjects received placebo on Days 1 - 28.
28357|NCT02465450|P2|Participant Flow|JBT-101 5 mg QD|JBT-101: 5 mg once a day on Days 1-28.
28358|NCT02465450|P1|Participant Flow|JBT101 1 mg QD|JBT-101: 1 mg once a day on Days 1-28
28359|NCT02465450|O6|Outcome|Placebo BID|"Placebo administered twice daily.~Subjects in this analysis group received placebo on Days 1 - 28."
28360|NCT02465450|O5|Outcome|Lenabasum 20 mg BID|"Lenabasum: 20 mg twice a day on Days 29 - 84.~Lenabasum: Subjects in this analysis group could have received 1 mg, 5 mg, or placebo during Days 1 - 28."
28361|NCT02465450|O4|Outcome|Lenabasum 20 mg QD|"Lenabasum: 20 mg once a day on Days 29 - 84.~Lenabasum: Subjects in this analysis group could have received 1 mg, 5 mg, or placebo during Days 1 - 28."
28362|NCT02465450|O3|Outcome|Placebo QD|Placebo: Subjects received placebo on Days 1 - 28.
28363|NCT02465450|O2|Outcome|Lenabasum 5 mg QD|Lenabasum: 5 mg once a day on Days 1-28.
28364|NCT02465450|O1|Outcome|Lenabasum 1 mg QD|Lenabasum: 1 mg once a day on Days 1-28
28365|NCT02465450|O6|Outcome|Placebo BID|"Placebo administered twice daily.~Subjects in this analysis group received placebo on Days 1 - 28."
28366|NCT02465450|O5|Outcome|JBT-101 20 mg BID|"JBT-101: 20 mg twice a day on Days 29 - 84.~JBT-101: Subjects in this analysis group could have received 1 mg, 5 mg, or placebo during Days 1 - 28."
28367|NCT02465450|O4|Outcome|JBT-101 20 mg QD|"JBT-101: 20 mg once a day on Days 29 - 84.~JBT-101: Subjects in this analysis group could have received 1 mg, 5 mg, or placebo during Days 1 - 28."
28371|NCT02465450|E6|Reported Event|Placebo BID|"Placebo administered twice daily.~Subjects in this analysis group received placebo on Days 1 - 28."
28372|NCT02465450|E5|Reported Event|JBT-101 20 mg BID|"JBT-101: 20 mg twice a day on Days 29 - 84.~JBT-101: Subjects in this analysis group could have received 1 mg, 5 mg, or placebo during Days 1 - 28."
28373|NCT02465450|E4|Reported Event|JBT-101 20 mg QD|"JBT-101: 20 mg once a day on Days 29 - 84.~JBT-101: Subjects in this analysis group could have received 1 mg, 5 mg, or placebo during Days 1 - 28."
28374|NCT02465450|E3|Reported Event|Placebo QD|Placebo: Subjects received placebo on Days 1 - 28.
28375|NCT02465450|E2|Reported Event|JBT-101 5 mg QD|JBT-101: 5 mg once a day on Days 1-28.
28376|NCT02465450|E1|Reported Event|JBT101 1 mg QD|JBT-101: 1 mg once a day on Days 1-28
28377|NCT02465203|B4|Baseline|Total|Total of all reporting groups
28378|NCT02465203|B3|Baseline|Study 2211 - Overall (N=13)|Follow up from feeder study NCT01215643
28379|NCT02465203|B2|Baseline|From Study 2301 (N=36)|Follow up from withdrawn feeder study NCT01318694
28380|NCT02465203|B1|Baseline|From Study 2210 (N=56)|Follow up from feeder study NCT01183169
28381|NCT02465203|P3|Participant Flow|From Study 2211 - Overall (N=13)|Follow up from feeder study NCT01215643
28382|NCT02465203|P2|Participant Flow|From Study 2301 (N=36)|Follow up from withdrawn feeder study NCT01318694
28383|NCT02465203|P1|Participant Flow|From Study 2210 (N=56)|Follow up from feeder study NCT01183169
28384|NCT02465203|O1|Outcome|All Arms|All participants in study
28385|NCT02465203|O1|Outcome|All Arms|All participants in study
28386|NCT02465203|O1|Outcome|All Arms|All participants in study
28387|NCT02465203|O1|Outcome|All Arms|All participants in study
28388|NCT02465203|O1|Outcome|All Arms|All participants in study
28389|NCT02465203|E4|Reported Event|A2211 Overall|From Study A2211 Overall (1 patient did not receive alisporivir in the feeder study and was excluded from Safety Set)
28390|NCT02465203|E3|Reported Event|A2211 IFN-free|From Study A2211 IFN-free (subset of Study 2211 overall)
28391|NCT02465203|E2|Reported Event|A2301|From Study A2301 (3 patients did not receive alisporivir in the feeder study and were excluded from Safety Set)
28392|NCT02465203|E1|Reported Event|A2210|From Study A2210 (3 patients did not receive alisporivir in the feeder study and were excluded from Safety Set)
28393|NCT02465099|B3|Baseline|Total|Total of all reporting groups
28394|NCT02465099|B2|Baseline|Phase II OSTEOVUE Ultrasonic Dissection|Patients meeting the study criteria, scheduled to undergo posterior spinal fusion using ultrasonic dissection and metal Cobb elevator for soft tissue dissection and removal from vertebral surfaces.
28395|NCT02465099|B1|Baseline|Phase 1 Monopolar Electrocautery Dissection|Patients meeting the study criteria, scheduled to undergo posterior spinal fusion using monopolar electrocautery and metal Cobb elevator (considered the current standard) for soft tissue dissection and removal from vertebral surfaces.
28396|NCT02465099|P2|Participant Flow|Phase II OSTEOVUE Ultrasonic Dissection|Patients meeting the study criteria, scheduled to undergo posterior spinal fusion using ultrasonic dissection and metal Cobb elevator for soft tissue dissection and removal from vertebral surfaces.
28397|NCT02465099|P1|Participant Flow|Phase 1 Monopolar Electrocautery Dissection|Patients meeting the study criteria, scheduled to undergo posterior spinal fusion using monopolar electrocautery and metal Cobb elevator (considered the current standard) for soft tissue dissection and removal from vertebral surfaces.
28398|NCT02465099|O2|Outcome|Phase II OSTEOVUE Ultrasonic Dissection|Patients meeting the study criteria, scheduled to undergo posterior spinal fusion using ultrasonic dissection and metal Cobb elevator for soft tissue dissection and removal from vertebral surfaces.
28399|NCT02465099|O1|Outcome|Phase 1 Monopolar Electrocautery Dissection|Patients meeting the study criteria, scheduled to undergo posterior spinal fusion using monopolar electrocautery and metal Cobb elevator (considered the current standard) for soft tissue dissection and removal from vertebral surfaces.
28400|NCT02465099|E2|Reported Event|Phase II OSTEOVUE Ultrasonic Dissection|Patients meeting the study criteria, scheduled to undergo posterior spinal fusion using ultrasonic dissection and metal Cobb elevator for soft tissue dissection and removal from vertebral surfaces.
28401|NCT02465099|E1|Reported Event|Phase 1 Monopolar Electrocautery Dissection|Patients meeting the study criteria, scheduled to undergo posterior spinal fusion using monopolar electrocautery and metal Cobb elevator (considered the current standard) for soft tissue dissection and removal from vertebral surfaces.
28402|NCT02465073|B4|Baseline|Total|Total of all reporting groups
28403|NCT02465073|B3|Baseline|Standard of Care|"This group will receive Standard of Care only.~Standard of Care Group: Subjects will receive Standard of Care only."
28404|NCT02465073|B2|Baseline|NXTSC Plus SOC|"This group will receive the NXTSC wound gel plus Standard of Care.~NXTSC wound gel plus Standard of Care: Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only."
28405|NCT02465073|B1|Baseline|NXTSC|"This group will receive the NXTSC gel only.~NXTSC wound gel: Subjects will receive NXTSC wound gel only."
28406|NCT02465073|P3|Participant Flow|Standard of Care|"This group will receive Standard of Care only.~Standard of Care Group: Subjects will receive Standard of Care only."
28407|NCT02465073|P2|Participant Flow|NXTSC Plus SOC|"This group will receive the NXTSC wound gel plus Standard of Care.~NXTSC wound gel plus Standard of Care: Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only."
28408|NCT02465073|P1|Participant Flow|NXTSC|"This group will receive the NXTSC gel only.~NXTSC wound gel: Subjects will receive NXTSC wound gel only."
28409|NCT02465073|O3|Outcome|Standard of Care|"This group will receive Standard of Care only.~Standard of Care Group: Subjects will receive Standard of Care only."
28410|NCT02465073|O2|Outcome|NXTSC Plus SOC|"This group will receive the NXTSC wound gel plus Standard of Care.~NXTSC wound gel plus Standard of Care: Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only."
28411|NCT02465073|O1|Outcome|NXTSC|"This group will receive the NXTSC gel only.~NXTSC wound gel: Subjects will receive NXTSC wound gel only."
28412|NCT02465073|E3|Reported Event|Standard of Care|"This group will receive Standard of Care only.~Standard of Care Group: Subjects will receive Standard of Care only."
28607|NCT02461693|O1|Outcome|Caffeine|"One-time treatment with 200mg caffeine pill~Caffeine: 200mg delivered as pill; one-time dose"
28413|NCT02465073|E2|Reported Event|NXTSC Plus SOC|"This group will receive the NXTSC wound gel plus Standard of Care.~NXTSC wound gel plus Standard of Care: Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only."
28414|NCT02465073|E1|Reported Event|NXTSC|"This group will receive the NXTSC gel only.~NXTSC wound gel: Subjects will receive NXTSC wound gel only."
28415|NCT02464176|B4|Baseline|Total|Total of all reporting groups
28416|NCT02464176|B3|Baseline|Control Group|"Normal saline will be used as a placebo control group given at the same time and in the same manner as the experimental groups following peripheral nerve block administration. The volume given intravenously will be identical for all groups.~Bupivacaine: Bupivacaine will be used in lumbar plexus nerve block mixture.~Epinephrine: Epinephrine will be used in lumbar plexus nerve block mixture.~Lumbar Plexus Nerve Block: This is the procedure that will be performed.~Saline: Patients randomized to the placebo group will receive normal saline intravenously."
28417|NCT02464176|B2|Baseline|8 mg Dexamethasone Group|"Following peripheral nerve block using bupivacaine and epinephrine administration, 8 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups.~Dexamethasone: A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc’s of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. The block will be tested for block success. Testing will be performed with a 25 gauge Whitacre needle . The subjects will then receive dexamethasone (4 or 8 mg) or placebo (saline) based on arm placement.~Bupivacaine: Bupivacaine will be used in lumbar plexus nerve block mixture.~Epinephrine: Epinephrine will be used in lumbar plexus nerve block mixture.~Lumbar Plexus Nerve Block: This is the procedure that will be performed."
28418|NCT02464176|B1|Baseline|4 mg Dexamethasone Group|"Following lumbar plexus nerve block administration using bupivacaine and epinephrine, 4 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups.~Dexamethasone: A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc’s of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. The block will be tested for block success. Testing will be performed with a 25 gauge Whitacre needle . The subjects will then receive dexamethasone (4 or 8 mg) or placebo (saline) based on arm placement.~Bupivacaine: Bupivacaine will be used in lumbar plexus nerve block mixture.~Epinephrine: Epinephrine will be used in lumbar plexus nerve block mixture.~Lumbar Plexus Nerve Block: This is the procedure that will be performed."
28419|NCT02464176|P3|Participant Flow|Control Group|Normal saline will be used as a placebo control group given at the same time and in the same manner as the experimental groups following peripheral nerve block administration. The volume given intravenously will be identical for all groups.
28420|NCT02464176|P2|Participant Flow|8 mg Dexamethasone Group|Following peripheral nerve block using bupivacaine and epinephrine administration, 8 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups.
28421|NCT02464176|P1|Participant Flow|4 mg Dexamethasone Group|Following lumbar plexus nerve block administration using bupivacaine and epinephrine, 4 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups.
28422|NCT02464176|O3|Outcome|Control Group|"Normal saline will be used as a placebo control group given at the same time and in the same manner as the experimental groups following peripheral nerve block administration. The volume given intravenously will be identical for all groups.~Bupivacaine: Bupivacaine will be used in lumbar plexus nerve block mixture.~Epinephrine: Epinephrine will be used in lumbar plexus nerve block mixture.~Lumbar Plexus Nerve Block: This is the procedure that will be performed.~Saline: Patients randomized to the placebo group will receive normal saline intravenously."
28423|NCT02464176|O2|Outcome|8 mg Dexamethasone Group|"Following peripheral nerve block using bupivacaine and epinephrine administration, 8 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups.~Dexamethasone: A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc’s of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. Successful blockade will be assumed if the patient has a decrease or loss of pinprick sensation in the femoral nerve distribution, which innervates the anterior thigh. If no evidence of blockade is present, testing will occur again at 30 minutes post block. Testing will be performed with a 25 gauge Whitacre needle and once present the area of testing will be marked with a surgical marking pen so that repeat sensory testing can be undertaken"
28424|NCT02464176|O1|Outcome|4 mg Dexamethasone Group|"Following lumbar plexus nerve block administration using bupivacaine and epinephrine, 4 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups.~Dexamethasone: A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc’s of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. Successful blockade will be assumed if the patient has a decrease or loss of pinprick sensation in the femoral nerve distribution, which innervates the anterior thigh. If no evidence of blockade is present, testing will occur again at 30 minutes post block. Testing will be performed with a 25 gauge Whitacre needle"
28425|NCT02464176|O3|Outcome|Control Group|"Normal saline will be used as a placebo control group given at the same time and in the same manner as the experimental groups following peripheral nerve block administration. The volume given intravenously will be identical for all groups.~Bupivacaine: Bupivacaine will be used in lumbar plexus nerve block mixture.~Epinephrine: Epinephrine will be used in lumbar plexus nerve block mixture.~Lumbar Plexus Nerve Block: This is the procedure that will be performed.~Saline: Patients randomized to the placebo group will receive normal saline intravenously."
28458|NCT02464163|O4|Outcome|Panblok 30µg (No Adjuvant)|"30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection"
28459|NCT02464163|O3|Outcome|Panblok 30µg in 2% SE|"30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
28426|NCT02464176|O2|Outcome|8 mg Dexamethasone Group|"Following peripheral nerve block using bupivacaine and epinephrine administration, 8 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups.~Dexamethasone: A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc’s of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. Successful blockade will be assumed if the patient has a decrease or loss of pinprick sensation in the femoral nerve distribution, which innervates the anterior thigh. If no evidence of blockade is present, testing will occur again at 30 minutes post block. Testing will be performed with a 25 gauge Whitacre needle and once present the area of testing will be marked with a surgical marking pen so that repeat sensory testing can be undertaken"
28427|NCT02464176|O1|Outcome|4 mg Dexamethasone Group|"Following lumbar plexus nerve block administration using bupivacaine and epinephrine, 4 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups.~Dexamethasone: A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc’s of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. Successful blockade will be assumed if the patient has a decrease or loss of pinprick sensation in the femoral nerve distribution, which innervates the anterior thigh. If no evidence of blockade is present, testing will occur again at 30 minutes post block. Testing will be performed with a 25 gauge Whitacre needle"
28428|NCT02464176|O3|Outcome|Control Group|"Normal saline will be used as a placebo control group given at the same time and in the same manner as the experimental groups following peripheral nerve block administration. The volume given intravenously will be identical for all groups.~Bupivacaine: Bupivacaine will be used in lumbar plexus nerve block mixture.~Epinephrine: Epinephrine will be used in lumbar plexus nerve block mixture.~Lumbar Plexus Nerve Block: This is the procedure that will be performed.~Saline: Patients randomized to the placebo group will receive normal saline intravenously."
28429|NCT02464176|O2|Outcome|8 mg Dexamethasone Group|"Following peripheral nerve block using bupivacaine and epinephrine administration, 8 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups.~Dexamethasone: A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc’s of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. Successful blockade will be assumed if the patient has a decrease or loss of pinprick sensation in the femoral nerve distribution, which innervates the anterior thigh. If no evidence of blockade is present, testing will occur again at 30 minutes post block. Testing will be performed with a 25 gauge Whitacre needle and once present the area of testing will be marked with a surgical marking pen so that repeat sensory testing can be undertaken"
28430|NCT02464176|O1|Outcome|4 mg Dexamethasone Group|"Following lumbar plexus nerve block administration using bupivacaine and epinephrine, 4 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups.~Dexamethasone: A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc’s of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. Successful blockade will be assumed if the patient has a decrease or loss of pinprick sensation in the femoral nerve distribution, which innervates the anterior thigh. If no evidence of blockade is present, testing will occur again at 30 minutes post block. Testing will be performed with a 25 gauge Whitacre needle"
28431|NCT02464176|O3|Outcome|Control Group|"Normal saline will be used as a placebo control group given at the same time and in the same manner as the experimental groups following peripheral nerve block administration. The volume given intravenously will be identical for all groups.~Bupivacaine: Bupivacaine will be used in lumbar plexus nerve block mixture.~Epinephrine: Epinephrine will be used in lumbar plexus nerve block mixture.~Lumbar Plexus Nerve Block: This is the procedure that will be performed.~Saline: Patients randomized to the placebo group will receive normal saline intravenously."
28432|NCT02464176|O2|Outcome|8 mg Dexamethasone Group|"Following peripheral nerve block using bupivacaine and epinephrine administration, 8 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups.~Dexamethasone: A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc’s of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. Successful blockade will be assumed if the patient has a decrease or loss of pinprick sensation in the femoral nerve distribution, which innervates the anterior thigh. If no evidence of blockade is present, testing will occur again at 30 minutes post block. Testing will be performed with a 25 gauge Whitacre needle and once present the area of testing will be marked with a surgical marking pen so that repeat sensory testing can be undertaken"
28433|NCT02464176|O1|Outcome|4 mg Dexamethasone Group|"Following lumbar plexus nerve block administration using bupivacaine and epinephrine, 4 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups.~Dexamethasone: A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc’s of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. Successful blockade will be assumed if the patient has a decrease or loss of pinprick sensation in the femoral nerve distribution, which innervates the anterior thigh. If no evidence of blockade is present, testing will occur again at 30 minutes post block. Testing will be performed with a 25 gauge Whitacre needle"
28434|NCT02464176|E3|Reported Event|Control Group|"Normal saline will be used as a placebo control group given at the same time and in the same manner as the experimental groups following peripheral nerve block administration. The volume given intravenously will be identical for all groups.~Bupivacaine: Bupivacaine will be used in lumbar plexus nerve block mixture.~Epinephrine: Epinephrine will be used in lumbar plexus nerve block mixture.~Lumbar Plexus Nerve Block: This is the procedure that will be performed.~Saline: Patients randomized to the placebo group will receive normal saline intravenously."
28603|NCT02461693|B1|Baseline|Caffeine|"One-time treatment with 200mg caffeine pill~Caffeine: 200mg delivered as pill; one-time dose"
28435|NCT02464176|E2|Reported Event|8 mg Dexamethasone Group|"Following peripheral nerve block using bupivacaine and epinephrine administration, 8 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups.~Dexamethasone: A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc’s of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. Successful blockade will be assumed if the patient has a decrease or loss of pinprick sensation in the femoral nerve distribution, which innervates the anterior thigh. If no evidence of blockade is present, testing will occur again at 30 minutes post block. Testing will be performed with a 25 gauge Whitacre needle and once present the area of testing will be marked with a surgical marking pen so that repeat sensory testing can be undertaken"
28436|NCT02464176|E1|Reported Event|4 mg Dexamethasone Group|"Following lumbar plexus nerve block administration using bupivacaine and epinephrine, 4 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups.~Dexamethasone: A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc’s of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. Successful blockade will be assumed if the patient has a decrease or loss of pinprick sensation in the femoral nerve distribution, which innervates the anterior thigh. If no evidence of blockade is present, testing will occur again at 30 minutes post block. Testing will be performed with a 25 gauge Whitacre needle"
28437|NCT02464163|B5|Baseline|Total|Total of all reporting groups
28438|NCT02464163|B4|Baseline|Panblok 30µg (No Adjuvant)|"30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection"
28439|NCT02464163|B3|Baseline|Panblok 30µg in 2% SE|"30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
28440|NCT02464163|B2|Baseline|Panblok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
28441|NCT02464163|B1|Baseline|Panblok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
28442|NCT02464163|P4|Participant Flow|Panblok 30µg (No Adjuvant)|"30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection"
28443|NCT02464163|P3|Participant Flow|Panblok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
28444|NCT02464163|P2|Participant Flow|Panblok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
28445|NCT02464163|P1|Participant Flow|Panblok 30µg in 2% SE|"30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
28446|NCT02464163|O4|Outcome|Panblok 30µg (No Adjuvant)|"30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection"
28447|NCT02464163|O3|Outcome|Panblok 30µg in 2% SE|"30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
28448|NCT02464163|O2|Outcome|Panblok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
28449|NCT02464163|O1|Outcome|Panblok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
28450|NCT02464163|O4|Outcome|Panblok 30µg (No Adjuvant)|"30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection"
28451|NCT02464163|O3|Outcome|Panblok 30µg in 2% SE|"30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
28452|NCT02464163|O2|Outcome|Panblok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
28453|NCT02464163|O1|Outcome|Panblok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
28454|NCT02464163|O4|Outcome|Panblok 30µg (No Adjuvant)|"30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection"
28455|NCT02464163|O3|Outcome|Panblok 30µg in 2% SE|"30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
28456|NCT02464163|O2|Outcome|Panblok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
28457|NCT02464163|O1|Outcome|Panblok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
28460|NCT02464163|O2|Outcome|Panblok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
28461|NCT02464163|O1|Outcome|Panblok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
28462|NCT02464163|E4|Reported Event|Panblok 30µg (No Adjuvant)|"30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection"
28463|NCT02464163|E3|Reported Event|Panblok 30µg in 2% SE|"30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
28464|NCT02464163|E2|Reported Event|Panblok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
28465|NCT02464163|E1|Reported Event|Panblok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~Panblok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
28466|NCT02463981|B3|Baseline|Total|Total of all reporting groups
28467|NCT02463981|B2|Baseline|Sham Control|"Sham control group receives sham neurofeedback from a large control brain region.~real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands)"
28468|NCT02463981|B1|Baseline|Neurofeedback Training|"Neurofeedback training group receives neurofeedback from their own anterior insula.~real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands)"
28469|NCT02463981|P2|Participant Flow|Sham Control|"Sham control group receives sham neurofeedback from a large control brain region.~real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands)"
28470|NCT02463981|P1|Participant Flow|Neurofeedback Training|"Neurofeedback training group receives neurofeedback from their own anterior insula.~real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands)"
28471|NCT02463981|O2|Outcome|Sham Control|"Sham control group receives sham neurofeedback from a large control brain region.~real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands)"
28472|NCT02463981|O1|Outcome|Neurofeedback Training|"Neurofeedback training group receives neurofeedback from their own anterior insula.~real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands)"
28473|NCT02463981|O2|Outcome|Sham Control|"Sham control group receives sham neurofeedback from a large control brain region.~real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands)"
28474|NCT02463981|O1|Outcome|Neurofeedback Training|"Neurofeedback training group receives neurofeedback from their own anterior insula.~real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands)"
28475|NCT02463981|E2|Reported Event|Sham Control|Subjects in this group received fMRI-based feedback from a unspecific control region
28476|NCT02463981|E1|Reported Event|Neurofeedback Training|Subjects in this group received fMRI-based feedback from their insula activity
28477|NCT02463409|B1|Baseline|Theophylline|"Patients will receive a 24 hour continuous infusion of intravenous theophylline.~Theophylline: 24 hour infusion of IV theophylline"
28478|NCT02463409|P1|Participant Flow|Theophylline|"Patients will receive a 24 hour continuous infusion of intravenous theophylline.~Theophylline: 24 hour infusion of IV theophylline"
28479|NCT02463409|O1|Outcome|Theophylline|"Patients will receive a 24 hour continuous infusion of intravenous theophylline.~Theophylline: 24 hour infusion of IV theophylline"
28480|NCT02463409|O1|Outcome|Theophylline|"Patients will receive a 24 hour continuous infusion of intravenous theophylline.~Theophylline: 24 hour infusion of IV theophylline"
28481|NCT02463409|O1|Outcome|Theophylline|"Patients will receive a 24 hour continuous infusion of intravenous theophylline.~Theophylline: 24 hour infusion of IV theophylline"
28482|NCT02463409|E1|Reported Event|Theophylline|"Patients will receive a 24 hour continuous infusion of intravenous theophylline.~Theophylline: 24 hour infusion of IV theophylline. All patients who enrolled in the study are included in this group (excluding screen fails)."
28483|NCT02463331|B3|Baseline|Total|Total of all reporting groups
28484|NCT02463331|B2|Baseline|Azathioprine Plus Prednisone|"azathioprine in variable doses (50-150mg/day) associated to prednisone in variable doses~prednisone: Prednisone 5-15 mg/day until the end of the study~azathioprine: azathioprine 1-2mg/Kg/day until the end of the study"
28485|NCT02463331|B1|Baseline|Chloroquine Plus Prednisone|"Chloroquine diphosphate 250mg/day associated to prednisone in variable doses~Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study~prednisone: Prednisone 5-15 mg/day until the end of the study"
28486|NCT02463331|P2|Participant Flow|Azathioprine Plus Prednisone|"azathioprine in variable doses (1-2mg/Kg/day) associated to prednisone in variable doses~prednisone: Prednisone 5-15 mg/day until the end of the study~azathioprine: azathioprine 1-2mg/Kg/day until the end of the study"
28487|NCT02463331|P1|Participant Flow|Chloroquine Plus Prednisone|"Chloroquine diphosphate 250mg/day associated to prednisone in variable doses~Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study~prednisone: Prednisone 5-15 mg/day until the end of the study"
28488|NCT02463331|O2|Outcome|Azathioprine Plus Prednisone|"azathioprine in variable doses (1-2mg/Kg/day) associated to prednisone in variable doses~prednisone: Prednisone 5-15 mg/day until the end of the study~azathioprine: azathioprine 1-2mg/Kg/day until the end of the study"
28489|NCT02463331|O1|Outcome|Chloroquine Plus Prednisone|"Chloroquine diphosphate 250mg/day associated to prednisone in variable doses~Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study~prednisone: Prednisone 5-15 mg/day until the end of the study"
28604|NCT02461693|P2|Participant Flow|Placebo|"One-time treatment with lactose-based placebo pill~Placebo"
28490|NCT02463331|O2|Outcome|Azathioprine Plus Prednisone|"azathioprine in variable doses (1-2mg/Kg/day) associated to prednisone in variable doses~prednisone: Prednisone 5-15 mg/day until the end of the study~azathioprine: azathioprine 1-2mg/Kg/day until the end of the study"
28491|NCT02463331|O1|Outcome|Chloroquine Plus Prednisone|"Chloroquine diphosphate 250mg/day associated to prednisone in variable doses~Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study~prednisone: Prednisone 5-15 mg/day until the end of the study"
28492|NCT02463331|E2|Reported Event|Azathioprine Plus Prednisone|"azathioprine in variable doses (1-2mg/Kg/day) associated to prednisone in variable doses~prednisone: Prednisone 5-15 mg/day until the end of the study~azathioprine: azathioprine 1-2mg/Kg/day until the end of the study"
28493|NCT02463331|E1|Reported Event|Chloroquine Plus Prednisone|"Chloroquine diphosphate 250mg/day associated to prednisone in variable doses~Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study~prednisone: Prednisone 5-15 mg/day until the end of the study"
28494|NCT02463227|B1|Baseline|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.~VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.~Administered over about 30 to 60 minutes using a volumetric pump."
28495|NCT02463227|P1|Participant Flow|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.~VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.~Administered over about 30 to 60 minutes using a volumetric pump."
28496|NCT02463227|O1|Outcome|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.~VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.~Administered over about 30 to 60 minutes using a volumetric pump."
28497|NCT02463227|O1|Outcome|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.~VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.~Administered over about 30 to 60 minutes using a volumetric pump."
28498|NCT02463227|O1|Outcome|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.~VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.~Administered over about 30 to 60 minutes using a volumetric pump."
28499|NCT02463227|O1|Outcome|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.~VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.~Administered over about 30 to 60 minutes using a volumetric pump."
28500|NCT02463227|O1|Outcome|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.~VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.~Administered over about 30 to 60 minutes using a volumetric pump."
28501|NCT02463227|E1|Reported Event|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.~VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.~Administered over about 30 to 60 minutes using a volumetric pump."
28502|NCT02463097|B1|Baseline|Study Arm|"All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm~Insulin Pump: Closed Loop Algorithm~i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation~Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required"
28503|NCT02463097|P1|Participant Flow|Study Arm|"All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm~Insulin Pump: Closed Loop Algorithm~i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation~Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required"
28504|NCT02463097|O1|Outcome|Study Arm|"All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm~Insulin Pump: Closed Loop Algorithm~i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation~Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required"
28505|NCT02463097|O1|Outcome|Study Arm|"All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm~Insulin Pump: Closed Loop Algorithm~i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation~Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required"
28506|NCT02463097|O1|Outcome|Study Arm|"All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm~Insulin Pump: Closed Loop Algorithm~i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation~Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required"
28507|NCT02463097|E1|Reported Event|Study Arm|"All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm~Insulin Pump: Closed Loop Algorithm~i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation~Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required"
28508|NCT02462720|B1|Baseline|Varithena®|"Varithena®: Varithena® treatment in accordance with full prescribing information and instructions for use followed by Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care.~Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care followed by Varithena®: Varithena® treatment in accordance with full prescribing information and instructions for use"
28509|NCT02462720|P2|Participant Flow|Radiofrequency Ablation First Than Varithena|"Patients will receive radiofrequency ablation treatment first in one leg, with 4-week follow-up period in Part 1; followed by Varithena® in the other leg in Part 2.~Varithena® treatment administered in accordance with full prescribing information and instructions for use.~Radiofrequency ablation conducted per physicians' standard of care"
28510|NCT02462720|P1|Participant Flow|Varithena® First Then Radiofrequency Ablation|"Patients receive Varithena® treatment first in one leg, with 4-week follow-up period in Part 1; followed by Radiofrequency ablation in the other leg in Part 2.~Varithena® treatment administered in accordance with full prescribing information and instructions for use.~Radiofrequency ablation conducted per physicians' standard of care"
28511|NCT02462720|O2|Outcome|Radiofrequency Ablation|"Varithena® treatment in accordance with full prescribing information and instructions for use~Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care."
28512|NCT02462720|O1|Outcome|Varithena®|"Varithena® treatment in accordance with full prescribing information and instructions for use~Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care."
28513|NCT02462720|O2|Outcome|Radiofrequency Ablation|"Varithena® treatment in accordance with full prescribing information and instructions for use~Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care."
28514|NCT02462720|O1|Outcome|Varithena®|"Varithena® treatment in accordance with full prescribing information and instructions for use~Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care."
28515|NCT02462720|O2|Outcome|Radiofrequency Ablation|"RFA procedures were conducted in accordance with the physician’s standard of care and according to the manufacturer’s instructions for use.~Varithena®: Varithena® treatment in accordance with full prescribing information and instructions for use~Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care."
28516|NCT02462720|O1|Outcome|Varithena®|"Varithena (polidocanol injectable foam) supplied as polidocanol solution 180 mg/18 mL (10 mg/mL) to be activated before use. Once activated, Varithena is a white injectable foam delivering a 1% polidocanol solution. Each milliliter of Varithena injectable foam contains 1.3 mg of polidocanol. Up to 5 mL per injection or 15 mL per treatment session could be used.~Varithena®: Varithena® treatment in accordance with full prescribing information and instructions for use~Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care."
28517|NCT02462720|E2|Reported Event|Radiofrequency Ablation|"Varithena® treatment in accordance with full prescribing information and instructions for use~Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care."
28518|NCT02462720|E1|Reported Event|Varithena®|"Varithena® treatment in accordance with full prescribing information and instructions for use~Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care."
28519|NCT02462473|B1|Baseline|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
28520|NCT02462473|P1|Participant Flow|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
28521|NCT02462473|O1|Outcome|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
28522|NCT02462473|O1|Outcome|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
28523|NCT02462473|O1|Outcome|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
28524|NCT02462473|O1|Outcome|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
28525|NCT02462473|O1|Outcome|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
28526|NCT02462473|O1|Outcome|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
28527|NCT02462473|O1|Outcome|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
28528|NCT02462473|O1|Outcome|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
28529|NCT02462473|E1|Reported Event|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
28530|NCT02462291|B3|Baseline|Total|Total of all reporting groups
28531|NCT02462291|B2|Baseline|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
28532|NCT02462291|B1|Baseline|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
28533|NCT02462291|P2|Participant Flow|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
28534|NCT02462291|P1|Participant Flow|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
28535|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
28536|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
28537|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
28538|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
28539|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
28540|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
28541|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
28542|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
28543|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
28544|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
28545|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
28546|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
28547|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
28548|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
28549|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD will be treated with the standard therapy.
28550|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
28551|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
28552|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
28553|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD will be treated with the standard therapy.
28554|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
28555|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD will be treated with the standard therapy.
28556|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
28557|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
28558|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
28559|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
28560|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
28561|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
28562|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
28563|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
28564|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
28565|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
28566|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
28567|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
28568|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
28569|NCT02462291|E2|Reported Event|Control Group (CTRL)|A group of 81 patients with AD will be treated with the standard therapy.
28605|NCT02461693|P1|Participant Flow|Caffeine|"One-time treatment with 200mg caffeine pill~Caffeine: 200mg delivered as pill; one-time dose"
36472|NCT02389088|O2|Outcome|Phase I - Week 5 - 0 Hour|
28570|NCT02462291|E1|Reported Event|Experimental Group (TR)|"A group of 82 patients with AD will perform a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
28571|NCT02461992|B1|Baseline|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
28572|NCT02461992|P1|Participant Flow|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
28573|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
28574|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
28575|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
28576|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
28577|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
28578|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
28579|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
28580|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
28581|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
28582|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
28583|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
28584|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
28585|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
28586|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
28587|NCT02461992|E1|Reported Event|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
28588|NCT02461966|B4|Baseline|Total|Total of all reporting groups
28589|NCT02461966|B3|Baseline|Control Group|"Estimation of serum aflatoxin level in 60 individuals, as a control group in patient house whom share the same quality of life and whom were neither HCC patients nor cirrhotic patients, were invited to share in the study~Aflatoxin: Evaluation of Aflatoxin level"
28590|NCT02461966|B2|Baseline|Cirrhotic Patients|"Estimation of serum aflatoxin level in 80 patients with liver cirrhosis~Aflatoxin: Evaluation of Aflatoxin level"
28591|NCT02461966|B1|Baseline|Hepatocellular Carcinoma (HCC)|"Estimation of serum aflatoxin level in 160 patients with hepatocellular carcinoma (HCC)~Aflatoxin: Evaluation of Aflatoxin level"
28592|NCT02461966|P3|Participant Flow|Control Group|"Estimation of serum aflatoxin level in 60 individuals, as a control group in patient house whom share the same quality of life and whom were neither HCC patients nor cirrhotic patients, were invited to share in the study~Aflatoxin: Evaluation of Aflatoxin level"
28593|NCT02461966|P2|Participant Flow|Cirrhotic Patients|"Estimation of serum aflatoxin level in 80 patients with liver cirrhosis~Aflatoxin: Evaluation of Aflatoxin level"
28594|NCT02461966|P1|Participant Flow|Hepatocellular Carcinoma (HCC)|"Estimation of serum aflatoxin level in 160 patients with hepatocellular carcinoma (HCC)~Aflatoxin: Evaluation of Aflatoxin level"
28595|NCT02461966|O3|Outcome|Control Group|"Estimation of serum aflatoxin level in 60 individuals, as a control group in patient house whom share the same quality of life and whom were neither HCC patients nor cirrhotic patients, were invited to share in the study~Aflatoxin: Evaluation of Aflatoxin level"
28596|NCT02461966|O2|Outcome|80 Cirrhotic Patients|"Estimation of serum aflatoxin level in 80 patients with liver cirrhosis~Aflatoxin: Evaluation of Aflatoxin level"
28597|NCT02461966|O1|Outcome|Hepatocellular Carcinoma (HCC)|"Estimation of serum aflatoxin level in 160 patients with hepatocellular carcinoma (HCC)~Aflatoxin: Evaluation of Aflatoxin level"
28598|NCT02461966|E3|Reported Event|Control Group|"Estimation of serum aflatoxin level in 60 individuals, as a control group in patient house whom share the same quality of life and whom were neither HCC patients nor cirrhotic patients, were invited to share in the study~Aflatoxin: Evaluation of Aflatoxin level"
28599|NCT02461966|E2|Reported Event|Cirrhotic Patients|"Estimation of serum aflatoxin level in 80 patients with liver cirrhosis~Aflatoxin: Evaluation of Aflatoxin level"
28600|NCT02461966|E1|Reported Event|Hepatocellular Carcinoma (HCC)|"Estimation of serum aflatoxin level in 160 patients with hepatocellular carcinoma (HCC)~Aflatoxin: Evaluation of Aflatoxin level"
28601|NCT02461693|B3|Baseline|Total|Total of all reporting groups
28602|NCT02461693|B2|Baseline|Placebo|"One-time treatment with lactose-based placebo pill~Placebo"
28609|NCT02461693|O1|Outcome|Caffeine|"One-time treatment with 200mg caffeine pill~Caffeine: 200mg delivered as pill; one-time dose"
28610|NCT02461693|O2|Outcome|Placebo|"One-time treatment with lactose-based placebo pill~Placebo"
28611|NCT02461693|O1|Outcome|Caffeine|"One-time treatment with 200mg caffeine pill~Caffeine: 200mg delivered as pill; one-time dose"
28612|NCT02461693|O2|Outcome|Placebo|"One-time treatment with lactose-based placebo pill~Placebo"
28613|NCT02461693|O1|Outcome|Caffeine|"One-time treatment with 200mg caffeine pill~Caffeine: 200mg delivered as pill; one-time dose"
28614|NCT02461693|E2|Reported Event|Placebo|"One-time treatment with lactose-based placebo pill~Placebo"
28615|NCT02461693|E1|Reported Event|Caffeine|"One-time treatment with 200mg caffeine pill~Caffeine: 200mg delivered as pill; one-time dose"
28616|NCT02461589|B11|Baseline|Total|Total of all reporting groups
28617|NCT02461589|B10|Baseline|Semaglutide Flexible|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator’s assessment.
28618|NCT02461589|B9|Baseline|Placebo|Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28619|NCT02461589|B8|Baseline|Liraglutide 1.8 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28620|NCT02461589|B7|Baseline|Liraglutide 1.2 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28621|NCT02461589|B6|Baseline|Liraglutide 0.6 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28622|NCT02461589|B5|Baseline|Liraglutide 0.3 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28623|NCT02461589|B4|Baseline|Semaglutide 0.3 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28624|NCT02461589|B3|Baseline|Semaglutide 0.2 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28625|NCT02461589|B2|Baseline|Semaglutide 0.1 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28626|NCT02461589|B1|Baseline|Semaglutide 0.05 mg/Day|Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28627|NCT02461589|P10|Participant Flow|Semaglutide Flexible|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator’s assessment.
28628|NCT02461589|P9|Participant Flow|Placebo|Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28629|NCT02461589|P8|Participant Flow|Liraglutide 1.8 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28630|NCT02461589|P7|Participant Flow|Liraglutide 1.2 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28631|NCT02461589|P6|Participant Flow|Liraglutide 0.6 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28632|NCT02461589|P5|Participant Flow|Liraglutide 0.3 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28633|NCT02461589|P4|Participant Flow|Semaglutide 0.3 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28634|NCT02461589|P3|Participant Flow|Semaglutide 0.2 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28635|NCT02461589|P2|Participant Flow|Semaglutide 0.1 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28636|NCT02461589|P1|Participant Flow|Semaglutide 0.05 mg/Day|Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28637|NCT02461589|O10|Outcome|Semaglutide Flexible|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator’s assessment.
28638|NCT02461589|O9|Outcome|Placebo|Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28639|NCT02461589|O8|Outcome|Liraglutide 1.8 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28640|NCT02461589|O7|Outcome|Liraglutide 1.2 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28641|NCT02461589|O6|Outcome|Liraglutide 0.6 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28642|NCT02461589|O5|Outcome|Liraglutide 0.3 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28643|NCT02461589|O4|Outcome|Semaglutide 0.3 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28644|NCT02461589|O3|Outcome|Semaglutide 0.2 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28645|NCT02461589|O2|Outcome|Semaglutide 0.1 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28646|NCT02461589|O1|Outcome|Semaglutide 0.05 mg/Day|Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28647|NCT02461589|O10|Outcome|Semaglutide Flexible|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator’s assessment.
28648|NCT02461589|O9|Outcome|Placebo|Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28649|NCT02461589|O8|Outcome|Liraglutide 1.8 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28650|NCT02461589|O7|Outcome|Liraglutide 1.2 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28690|NCT02461550|E1|Reported Event|IRE Procedure|"The IRE procedure will be performed in the operating room at the time of scheduled clinical resection of colorectal lung metastases by the surgeon with guidance from the Interventional Radiologist.~Irreversible Electroporation Ablation"
28651|NCT02461589|O6|Outcome|Liraglutide 0.6 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28652|NCT02461589|O5|Outcome|Liraglutide 0.3 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28653|NCT02461589|O4|Outcome|Semaglutide 0.3 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28654|NCT02461589|O3|Outcome|Semaglutide 0.2 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28655|NCT02461589|O2|Outcome|Semaglutide 0.1 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28656|NCT02461589|O1|Outcome|Semaglutide 0.05 mg/Day|Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28657|NCT02461589|O10|Outcome|Semaglutide Flexible|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator’s assessment.
28658|NCT02461589|O9|Outcome|Placebo|Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28659|NCT02461589|O8|Outcome|Liraglutide 1.8 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28660|NCT02461589|O7|Outcome|Liraglutide 1.2 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28661|NCT02461589|O6|Outcome|Liraglutide 0.6 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28662|NCT02461589|O5|Outcome|Liraglutide 0.3 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28663|NCT02461589|O4|Outcome|Semaglutide 0.3 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28664|NCT02461589|O3|Outcome|Semaglutide 0.2 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28665|NCT02461589|O2|Outcome|Semaglutide 0.1 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28666|NCT02461589|O1|Outcome|Semaglutide 0.05 mg/Day|Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28667|NCT02461589|O10|Outcome|Semaglutide Flexible|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator’s assessment.
28668|NCT02461589|O9|Outcome|Placebo|Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28669|NCT02461589|O8|Outcome|Liraglutide 1.8 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28691|NCT02461433|B3|Baseline|Total|Total of all reporting groups
28670|NCT02461589|O7|Outcome|Liraglutide 1.2 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28671|NCT02461589|O6|Outcome|Liraglutide 0.6 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28672|NCT02461589|O5|Outcome|Liraglutide 0.3 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28673|NCT02461589|O4|Outcome|Semaglutide 0.3 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28674|NCT02461589|O3|Outcome|Semaglutide 0.2 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28675|NCT02461589|O2|Outcome|Semaglutide 0.1 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28676|NCT02461589|O1|Outcome|Semaglutide 0.05 mg/Day|Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28677|NCT02461589|E10|Reported Event|Semaglutide Flexible|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator’s assessment.
28678|NCT02461589|E9|Reported Event|Placebo|Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28679|NCT02461589|E8|Reported Event|Liraglutide 1.8 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28680|NCT02461589|E7|Reported Event|Liraglutide 1.2 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28681|NCT02461589|E6|Reported Event|Liraglutide 0.6 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28682|NCT02461589|E5|Reported Event|Liraglutide 0.3 mg/Day|Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28683|NCT02461589|E4|Reported Event|Semaglutide 0.3 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28684|NCT02461589|E3|Reported Event|Semaglutide 0.2 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28685|NCT02461589|E2|Reported Event|Semaglutide 0.1 mg/Day|Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28686|NCT02461589|E1|Reported Event|Semaglutide 0.05 mg/Day|Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.
28687|NCT02461550|B1|Baseline|IRE Procedure|"The IRE procedure will be performed in the operating room at the time of scheduled clinical resection of colorectal lung metastases by the surgeon with guidance from the Interventional Radiologist.~Irreversible Electroporation Ablation"
28688|NCT02461550|P1|Participant Flow|IRE Procedure|"The IRE procedure will be performed in the operating room at the time of scheduled clinical resection of colorectal lung metastases by the surgeon with guidance from the Interventional Radiologist.~Irreversible Electroporation Ablation"
28689|NCT02461550|O1|Outcome|IRE Procedure|"The IRE procedure will be performed in the operating room at the time of scheduled clinical resection of colorectal lung metastases by the surgeon with guidance from the Interventional Radiologist.~Irreversible Electroporation Ablation"
28772|NCT02460159|O2|Outcome|EZ 10 mg/Atorva 20 mg FDC|One EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks.
28692|NCT02461433|B2|Baseline|Standard Dressing|"After surgery this group will receive standard of care dressings on their surgical wound.~Standard Dressing: This involves standard of care dressing including but not limited to gauze."
28693|NCT02461433|B1|Baseline|Prevena|"After surgery this group will receive the Prevena device (negative pressure wound therapy).~Prevena: Prevena Incision Management system"
28694|NCT02461433|P2|Participant Flow|Standard Dressing|"After surgery this group will receive standard of care dressings on their surgical wound.~Standard Dressing: This involves standard of care dressing including but not limited to gauze."
28695|NCT02461433|P1|Participant Flow|Prevena|"After surgery this group will receive the Prevena device (negative pressure wound therapy).~Prevena: Prevena Incision Management system"
28696|NCT02461433|O2|Outcome|Standard Dressing|"After surgery this group will receive standard of care dressings on their surgical wound.~Standard Dressing: This involves standard of care dressing including but not limited to gauze."
28697|NCT02461433|O1|Outcome|Prevena|"After surgery this group will receive the Prevena device (negative pressure wound therapy).~Prevena: Prevena Incision Management system"
28698|NCT02461433|O2|Outcome|Standard Dressing|"After surgery this group will receive standard of care dressings on their surgical wound.~Standard Dressing: This involves standard of care dressing including but not limited to gauze."
28699|NCT02461433|O1|Outcome|Prevena|"After surgery this group will receive the Prevena device (negative pressure wound therapy).~Prevena: Prevena Incision Management system"
28700|NCT02461433|O2|Outcome|Standard Dressing|"After surgery this group will receive standard of care dressings on their surgical wound.~Standard Dressing: This involves standard of care dressing including but not limited to gauze."
28701|NCT02461433|O1|Outcome|Prevena|"After surgery this group will receive the Prevena device (negative pressure wound therapy).~Prevena: Prevena Incision Management system"
28702|NCT02461433|O2|Outcome|Standard Dressing|"After surgery this group will receive standard of care dressings on their surgical wound.~Standard Dressing: This involves standard of care dressing including but not limited to gauze."
28703|NCT02461433|O1|Outcome|Prevena|"After surgery this group will receive the Prevena device (negative pressure wound therapy).~Prevena: Prevena Incision Management system"
28704|NCT02461433|O2|Outcome|Standard Dressing|"After surgery this group will receive standard of care dressings on their surgical wound.~Standard Dressing: This involves standard of care dressing including but not limited to gauze."
28705|NCT02461433|O1|Outcome|Prevena|"After surgery this group will receive the Prevena device (negative pressure wound therapy).~Prevena: Prevena Incision Management system"
28706|NCT02461433|O2|Outcome|Standard Dressing|"After surgery this group will receive standard of care dressings on their surgical wound.~Standard Dressing: This involves standard of care dressing including but not limited to gauze."
28707|NCT02461433|O1|Outcome|Prevena|"After surgery this group will receive the Prevena device (negative pressure wound therapy).~Prevena: Prevena Incision Management system"
28708|NCT02461433|O2|Outcome|Standard Dressing|"After surgery this group will receive standard of care dressings on their surgical wound.~Standard Dressing: This involves standard of care dressing including but not limited to gauze."
28709|NCT02461433|O1|Outcome|Prevena|"After surgery this group will receive the Prevena device (negative pressure wound therapy).~Prevena: Prevena Incision Management system"
28710|NCT02461433|O2|Outcome|Standard Dressing|"After surgery this group will receive standard of care dressings on their surgical wound.~Standard Dressing: This involves standard of care dressing including but not limited to gauze."
28711|NCT02461433|O1|Outcome|Prevena|"After surgery this group will receive the Prevena device (negative pressure wound therapy).~Prevena: Prevena Incision Management system"
28712|NCT02461433|O2|Outcome|Standard Dressing|"After surgery this group will receive standard of care dressings on their surgical wound.~Standard Dressing: This involves standard of care dressing including but not limited to gauze."
28713|NCT02461433|O1|Outcome|Prevena|"After surgery this group will receive the Prevena device (negative pressure wound therapy).~Prevena: Prevena Incision Management system"
28714|NCT02461433|O2|Outcome|Standard Dressing|"After surgery this group will receive standard of care dressings on their surgical wound.~Standard Dressing: This involves standard of care dressing including but not limited to gauze."
28715|NCT02461433|O1|Outcome|Prevena|"After surgery this group will receive the Prevena device (negative pressure wound therapy).~Prevena: Prevena Incision Management system"
28716|NCT02461433|O2|Outcome|Standard Dressing|"After surgery this group will receive standard of care dressings on their surgical wound.~Standard Dressing: This involves standard of care dressing including but not limited to gauze."
28717|NCT02461433|O1|Outcome|Prevena|"After surgery this group will receive the Prevena device (negative pressure wound therapy).~Prevena: Prevena Incision Management system"
28718|NCT02461433|E2|Reported Event|Standard Dressing|"After surgery this group will receive standard of care dressings on their surgical wound.~Standard Dressing: This involves standard of care dressing including but not limited to gauze."
28719|NCT02461433|E1|Reported Event|Prevena|"After surgery this group will receive the Prevena device (negative pressure wound therapy).~Prevena: Prevena Incision Management system"
28720|NCT02461290|B1|Baseline|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
28721|NCT02461290|P1|Participant Flow|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated follicular lymphoma (FL) received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included cyclophosphamide, vincristine, and prednisone (CVP); cyclophosphamide, doxorubin, vincristine, and predisone (CHOP); or fludarabine, cyclophosphamide, and mitoxantrone (FCM). Rituximab was administered as 375 milligrams per meter-squared (mg/m^2) via intravenous (IV) infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
36473|NCT02389088|O1|Outcome|Phase I - Week 0 - 24 Hours|
28722|NCT02461290|O1|Outcome|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
28723|NCT02461290|O1|Outcome|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
28724|NCT02461290|O1|Outcome|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
28725|NCT02461290|O1|Outcome|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
28726|NCT02461290|E1|Reported Event|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
28727|NCT02461134|B1|Baseline|Ponesimod|It was planned that enrolled subjects receive ponesimod in escalating doses of 5, 10 and 20 mg over the course of the treatment period of 24 weeks in total (4 weeks of 5 mg incl. up-titration, 4 weeks of 10 mg incl. up-titration and 16 weeks of 20 mg).
28728|NCT02461134|P1|Participant Flow|Ponesimod|It was planned that enrolled subjects receive ponesimod in escalating doses of 5, 10 and 20 mg over the course of the treatment period of 24 weeks in total (4 weeks of 5 mg incl. up-titration, 4 weeks of 10 mg incl. up-titration and 16 weeks of 20 mg).
28729|NCT02461134|O1|Outcome|Ponesimod|It was planned that enrolled subjects receive ponesimod in escalating doses of 5, 10 and 20 mg over the course of the treatment period of 24 weeks in total (4 weeks of 5 mg incl. up-titration, 4 weeks of 10 mg incl. up-titration and 16 weeks of 20 mg).
28730|NCT02461134|O1|Outcome|Ponesimod|It was planned that enrolled subjects receive ponesimod in escalating doses of 5, 10 and 20 mg over the course of the treatment period of 24 weeks in total (4 weeks of 5 mg incl. up-titration, 4 weeks of 10 mg incl. up-titration and 16 weeks of 20 mg).
28731|NCT02461134|O1|Outcome|Ponesimod|It was planned that enrolled subjects receive ponesimod in escalating doses of 5, 10 and 20 mg over the course of the treatment period of 24 weeks in total (4 weeks of 5 mg incl. up-titration, 4 weeks of 10 mg incl. up-titration and 16 weeks of 20 mg).
28732|NCT02461134|E1|Reported Event|Ponesimod|It was planned that enrolled subjects receive ponesimod in escalating doses of 5, 10 and 20 mg over the course of the treatment period of 24 weeks in total (4 weeks of 5 mg incl. up-titration, 4 weeks of 10 mg incl. up-titration and 16 weeks of 20 mg).
28733|NCT02460991|B3|Baseline|Total|Total of all reporting groups
28734|NCT02460991|B2|Baseline|Sorafenib|200 mg of Sorafenib twice daily; continue until unacceptable toxicity or unequivocal tumor progression
28735|NCT02460991|B1|Baseline|DEB-TACE|ONCO-DOX (Doxorubicin loaded Microspheres) up to 150 mg per treatment; treatments could be repeated every 4-8 weeks until complete tumor response was achieved
28736|NCT02460991|P2|Participant Flow|Sorafenib|200 mg of Sorafenib twice daily; continue until unacceptable toxicity or unequivocal tumor progression
28737|NCT02460991|P1|Participant Flow|DEB-TACE|ONCO-DOX (Doxorubicin loaded Microspheres) up to 150 mg per treatment; treatments could be repeated every 4-8 weeks until complete tumor response was achieved.
28738|NCT02460991|O2|Outcome|Sorafenib|200 mg Sorafenib twice daily; continue until unacceptable toxicity or unequivocal tumor progression
28739|NCT02460991|O1|Outcome|DEB-TACE|ONCO-DOX (Doxorubicin loaded Microspheres) up to 150 mg per treatment; treatments can be repeated every 4-8 weeks until complete tumor response is achieved.
28740|NCT02460991|E2|Reported Event|Sorafenib|200 mg of Sorafenib twice daily; continue until unacceptable toxicity or unequivocal tumor progression
28741|NCT02460991|E1|Reported Event|DEB-TACE|ONCO-DOX (Doxorubicin loaded Microspheres) up to 150 mg per treatment; treatments could be repeated every 4-8 weeks until complete tumor response was achieved
28742|NCT02460822|B1|Baseline|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.~MyChemoCare iPad application"
28743|NCT02460822|P1|Participant Flow|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.~MyChemoCare iPad application"
28773|NCT02460159|O1|Outcome|EZ 10 mg/Atorva 10 mg FDC|One ezetimibe (EZ) 10 mg/atorvastatin (Atorva) 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks.
28744|NCT02460822|O1|Outcome|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.~MyChemoCare iPad application"
28745|NCT02460822|O1|Outcome|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.~MyChemoCare iPad application"
28746|NCT02460822|O1|Outcome|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.~MyChemoCare iPad application"
28747|NCT02460822|O1|Outcome|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.~MyChemoCare iPad application"
28748|NCT02460822|O1|Outcome|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.~MyChemoCare iPad application"
28749|NCT02460822|O1|Outcome|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.~MyChemoCare iPad application"
28750|NCT02460822|E1|Reported Event|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.~MyChemoCare iPad application"
28751|NCT02460458|B1|Baseline|Type 3 VWD|Diagnosis of Type 3 von Willebrand Disease
28752|NCT02460458|P1|Participant Flow|Type 3 VWD|Diagnosis of Type 3 von Willebrand Disease
28753|NCT02460458|O1|Outcome|Type 3 VWD|Diagnosis of Type 3 von Willebrand Disease
28754|NCT02460458|O1|Outcome|Type 3 VWD|Diagnosis of Type 3 von Willebrand Disease
28755|NCT02460458|O1|Outcome|Type 3 VWD|Diagnosis of Type 3 von Willebrand Disease
28756|NCT02460458|E1|Reported Event|Type 3 VWD|Diagnosis of Type 3 von Willebrand Disease
28757|NCT02460159|B3|Baseline|Total|Total of all reporting groups
28758|NCT02460159|B2|Baseline|EZ 10 mg/Atorva 20 mg FDC|One EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks.
28759|NCT02460159|B1|Baseline|EZ 10 mg/Atorva 10 mg FDC|One ezetimibe (EZ) 10 mg/atorvastatin (Atorva) 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks.
28760|NCT02460159|P2|Participant Flow|EZ 10 mg/Atorva 20 mg FDC|One EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks.
28761|NCT02460159|P1|Participant Flow|EZ 10 mg/Atorva 10 mg FDC|One ezetimibe (EZ) 10 mg/atorvastatin (Atorva) 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks.
28762|NCT02460159|O2|Outcome|EZ 10 mg/Atorva 20 mg FDC|One EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks.
28763|NCT02460159|O1|Outcome|EZ 10 mg/Atorva 10 mg FDC|One ezetimibe (EZ) 10 mg/atorvastatin (Atorva) 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks.
28764|NCT02460159|O2|Outcome|EZ 10 mg/Atorva 20 mg FDC|One EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks.
28765|NCT02460159|O1|Outcome|EZ 10 mg/Atorva 10 mg FDC|One ezetimibe (EZ) 10 mg/atorvastatin (Atorva) 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks.
28766|NCT02460159|O2|Outcome|EZ 10 mg/Atorva 20 mg FDC|One EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks.
28767|NCT02460159|O1|Outcome|EZ 10 mg/Atorva 10 mg FDC|One ezetimibe (EZ) 10 mg/atorvastatin (Atorva) 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks.
28768|NCT02460159|O2|Outcome|EZ 10 mg/Atorva 20 mg FDC|One EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks.
28769|NCT02460159|O1|Outcome|EZ 10 mg/Atorva 10 mg FDC|One ezetimibe (EZ) 10 mg/atorvastatin (Atorva) 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks.
28770|NCT02460159|O2|Outcome|EZ 10 mg/Atorva 20 mg FDC|One EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks.
28771|NCT02460159|O1|Outcome|EZ 10 mg/Atorva 10 mg FDC|One ezetimibe (EZ) 10 mg/atorvastatin (Atorva) 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks.
28774|NCT02460159|O2|Outcome|EZ 10 mg/Atorva 20 mg FDC|One EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks.
28775|NCT02460159|O1|Outcome|EZ 10 mg/Atorva 10 mg FDC|One ezetimibe (EZ) 10 mg/atorvastatin (Atorva) 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks.
28776|NCT02460159|O2|Outcome|EZ 10 mg/Atorva 20 mg FDC|One EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks.
28777|NCT02460159|O1|Outcome|EZ 10 mg/Atorva 10 mg FDC|One ezetimibe (EZ) 10 mg/atorvastatin (Atorva) 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks.
28778|NCT02460159|O2|Outcome|EZ 10 mg/Atorva 20 mg FDC|One EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks.
28779|NCT02460159|O1|Outcome|EZ 10 mg/Atorva 10 mg FDC|One ezetimibe (EZ) 10 mg/atorvastatin (Atorva) 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks.
28780|NCT02460159|O2|Outcome|EZ 10 mg/Atorva 20 mg FDC|One EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks.
28781|NCT02460159|O1|Outcome|EZ 10 mg/Atorva 10 mg FDC|One ezetimibe (EZ) 10 mg/atorvastatin (Atorva) 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks.
28782|NCT02460159|O2|Outcome|EZ 10 mg/Atorva 20 mg FDC|One EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks.
28783|NCT02460159|O1|Outcome|EZ 10 mg/Atorva 10 mg FDC|One ezetimibe (EZ) 10 mg/atorvastatin (Atorva) 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks.
28784|NCT02460159|O2|Outcome|EZ 10 mg/Atorva 20 mg FDC|One EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks.
28785|NCT02460159|O1|Outcome|EZ 10 mg/Atorva 10 mg FDC|One ezetimibe (EZ) 10 mg/atorvastatin (Atorva) 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks.
28786|NCT02460159|E2|Reported Event|EZ10/AT20|One EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks.
28787|NCT02460159|E1|Reported Event|EZ10/AT10|One ezetimibe (EZ) 10 mg/atorvastatin (Atorva) 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks.
28788|NCT02459418|B3|Baseline|Total|Total of all reporting groups
28789|NCT02459418|B2|Baseline|Gonal-f® RFF Then AFOLIA|"On study day -1 (10 days after administration of LupronDepot®) subjects were assessed for eligibility of treatment by confirmation of down regulation of endogenous FSH levels. If down regulation was not confirmed the evaluation may have been repeated up to 7 days later.~Period 1: On study day 1, eligible subjects received a single s.c. dose of the first FSH preparation, 225 IU Gonal-f® RFF, in the abdomen. On study day 16, subjects received a second LupronDepot® i.m. injection.~Period 2: On study day 26, subjects underwent a further FSH down regulation assessment. This evaluation was repeated up to 7 days later if required and if down regulation was not confirmed after the second evaluation, the subject was no longer able to continue in the study. If eligibility was confirmed, the subject received the alternative FSH preparation of 225 IU AFOLIA on study day 27.~Exit examinations were performed on study day 35."
28790|NCT02459418|B1|Baseline|AFOLIA Then Gonal-f® RFF|"On study day -1 (10 days after administration of LupronDepot®) subjects were assessed for eligibility of treatment by confirmation of down regulation of endogenous FSH levels. If down regulation was not confirmed the evaluation may have been repeated up to 7 days later.~Period 1: On study day 1, eligible subjects received a single s.c. dose of the first FSH preparation, 225 International Units (IU) AFOLIA, in the abdomen. On study day 16, subjects received a second LupronDepot® i.m. injection.~Period 2: On study day 26, subjects underwent a further FSH down regulation assessment. This evaluation was repeated up to 7 days later if required and if down regulation was not confirmed after the second evaluation, the subject was no longer able to continue in the study. If eligibility was confirmed, the subject received the alternative FSH preparation, 225 IU Gonal-f® RFF on study day 27.~Exit examinations were performed on study day 35."
28791|NCT02459418|P2|Participant Flow|Gonal-f® RFF Then AFOLIA|"On study day -1 (10 days after administration of LupronDepot®) subjects were assessed for eligibility of treatment by confirmation of down regulation of endogenous FSH levels. If down regulation was not confirmed the evaluation may have been repeated up to 7 days later.~Period 1: On study day 1, eligible subjects received a single s.c. dose of the first FSH preparation, 225 IU Gonal-f® RFF, in the abdomen. On study day 16, subjects received a second LupronDepot® i.m. injection.~Period 2: On study day 26, subjects underwent a further FSH down regulation assessment. This evaluation was repeated up to 7 days later if required and if down regulation was not confirmed after the second evaluation, the subject was no longer able to continue in the study. If eligibility was confirmed, the subject received the alternative FSH preparation of 225 IU AFOLIA on study day 27. Exit examinations were performed on study day 35."
28792|NCT02459418|P1|Participant Flow|AFOLIA Then Gonal-f® RFF|"On study day -1 (10 days after administration of LupronDepot®) subjects were assessed for eligibility of treatment by confirmation of down regulation of endogenous FSH levels. If down regulation was not confirmed the evaluation may have been repeated up to 7 days later.~Period 1: On study day 1, eligible subjects received a single subcutaneous (s.c.) dose of the first FSH preparation, 225 International Units (IU) AFOLIA, in the abdomen. On study day 16, subjects received a second LupronDepot® intramuscular (i.m.) injection.~Period 2: On study day 26, subjects underwent a further FSH down regulation assessment. This evaluation was repeated up to 7 days later if required and if down regulation was not confirmed after the second evaluation, the subject was no longer able to continue in the study. If eligibility was confirmed, the subject received the alternative FSH preparation, 225 IU Gonal-f® RFF, on study day 27. Exit examinations were performed on study day 35."
28793|NCT02459418|O2|Outcome|Gonal-f® RFF|All subjects who received the test product 225 IU Gonal-f® RFF and had at least 1 measured concentration at a scheduled PK or PD time point after administration of Gonal-f® RFF.
28794|NCT02459418|O1|Outcome|AFOLIA|All subjects who received the test product 225 IU AFOLIA and had at least 1 measured concentration at a scheduled PK or PD time point after administration of AFOLIA.
28795|NCT02459418|O2|Outcome|Gonal-f® RFF|All subjects who received the test product 225 IU Gonal-f® RFF and had at least 1 measured concentration at a scheduled PK or PD time point after administration of Gonal-f® RFF.
28796|NCT02459418|O1|Outcome|AFOLIA|All subjects who received the test product 225 IU AFOLIA and had at least 1 measured concentration at a scheduled PK or PD time point after administration of AFOLIA.
28797|NCT02459418|O2|Outcome|Gonal-f® RFF|All subjects who received the test product 225 IU Gonal-f® RFF and had at least 1 measured concentration at a scheduled PK or PD time point after administration of Gonal-f® RFF.
28798|NCT02459418|O1|Outcome|AFOLIA|All subjects who received the test product 225 IU AFOLIA and had at least 1 measured concentration at a scheduled PK or PD time point after administration of AFOLIA.
28799|NCT02459418|O2|Outcome|Gonal-f® RFF|All subjects who received the test product 225 IU Gonal-f® RFF and had at least 1 measured concentration at a scheduled PK or PD time point after administration of Gonal-f® RFF.
28800|NCT02459418|O1|Outcome|AFOLIA|All subjects who received the test product 225 IU AFOLIA and had at least 1 measured concentration at a scheduled PK or PD time point after administration of AFOLIA.
28801|NCT02459418|O2|Outcome|Gonal-f® RFF|All subjects who received the test product 225 IU Gonal-f® RFF and had at least 1 measured concentration at a scheduled PK or PD time point after administration of Gonal-f® RFF.
28802|NCT02459418|O1|Outcome|AFOLIA|All subjects who received the test product 225 IU AFOLIA and had at least 1 measured concentration at a scheduled PK or PD time point after administration of AFOLIA.
28803|NCT02459418|O2|Outcome|Gonal-f® RFF|All subjects who received the test product 225 IU Gonal-f® RFF and had at least 1 measured concentration at a scheduled PK or PD time point after administration of Gonal-f® RFF.
28804|NCT02459418|O1|Outcome|AFOLIA|All subjects who received the test product 225 IU AFOLIA and had at least 1 measured concentration at a scheduled PK or PD time point after administration of AFOLIA.
28805|NCT02459418|O2|Outcome|Gonal-f® RFF|All subjects who received the test product Gonal-f® RFF and had at least 1 measured concentration at a scheduled PK or PD time point after administration of Gonal-f® RFF.
28806|NCT02459418|O1|Outcome|AFOLIA|All subjects who received the test product AFOLIA and had at least 1 measured concentration at a scheduled PK or PD time point after administration of AFOLIA.
28807|NCT02459418|O2|Outcome|Gonal-f® RFF|All subjects who received the test product 225 IU Gonal-f® RFF and had at least 1 measured concentration at a scheduled PK or PD time point after administration of Gonal-f® RFF.
28808|NCT02459418|O1|Outcome|AFOLIA|All subjects who received the test product 225 IU AFOLIA and had at least 1 measured concentration at a scheduled pharmacokinetic (PK) or pharmacodynamic (PD) time point after administration of AFOLIA.
28809|NCT02459418|E2|Reported Event|Gonal-f® RFF|This analysis set contained all subjects who received one dose of Gonal-f® RFF (225 IU).
28810|NCT02459418|E1|Reported Event|AFOLIA|This analysis set contained all subjects who received one dose of AFOLIA (225 IU).
28811|NCT02458768|B3|Baseline|Total|Total of all reporting groups
28812|NCT02458768|B2|Baseline|Menopur® Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~Menopur® Inj."
28813|NCT02458768|B1|Baseline|IVF-M HP Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~IVF-M HP Inj."
28814|NCT02458768|P2|Participant Flow|Menopur® Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~Menopur® Inj."
28815|NCT02458768|P1|Participant Flow|IVF-M HP Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~IVF-M HP Inj."
28816|NCT02458768|O2|Outcome|Menopur® Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~Menopur® Inj."
28817|NCT02458768|O1|Outcome|IVF-M HP Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~IVF-M HP Inj."
28818|NCT02458768|E2|Reported Event|Menopur® Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~Menopur® Inj."
28819|NCT02458768|E1|Reported Event|IVF-M HP Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~IVF-M HP Inj."
28820|NCT02458365|B3|Baseline|Total|Total of all reporting groups
28821|NCT02458365|B2|Baseline|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
28835|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
29110|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
28822|NCT02458365|B1|Baseline|Intevention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
28823|NCT02458365|P2|Participant Flow|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
28824|NCT02458365|P1|Participant Flow|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
28825|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
28826|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
28827|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
28828|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
28829|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
28830|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
28831|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
28832|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
28833|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
28834|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
37220|NCT02379637|E2|Reported Event|B Placebo|"Placebo~Placebo"
28836|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
28837|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
28838|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
28839|NCT02458365|O2|Outcome|Comparison: Health in Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
28840|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
28841|NCT02458365|E2|Reported Event|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
28842|NCT02458365|E1|Reported Event|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
28843|NCT02458287|B5|Baseline|Total|Total of all reporting groups
28844|NCT02458287|B4|Baseline|Bococizumab 75 mg|Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28845|NCT02458287|B3|Baseline|Placebo Matched to Bococizumab 75 mg|Participants received single dose of placebo matched to bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28846|NCT02458287|B2|Baseline|Bococizumab 150 mg|Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28847|NCT02458287|B1|Baseline|Placebo Matched to Bococizumab 150 mg|Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.
28848|NCT02458287|P4|Participant Flow|Bococizumab 75 mg|Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28849|NCT02458287|P3|Participant Flow|Placebo Matched to Bococizumab 75 mg|Participants received single dose of placebo matched to bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28850|NCT02458287|P2|Participant Flow|Bococizumab 150 mg|Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28851|NCT02458287|P1|Participant Flow|Placebo Matched to Bococizumab 150 mg|Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.
28852|NCT02458287|O4|Outcome|Bococizumab 75 mg|Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28853|NCT02458287|O3|Outcome|Placebo Matched to Bococizumab 75 mg|Participants received single dose of placebo matched to bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28854|NCT02458287|O2|Outcome|Bococizumab 150 mg|Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28855|NCT02458287|O1|Outcome|Placebo Matched to Bococizumab 150 mg|Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.
28856|NCT02458287|O2|Outcome|Bococizumab 75 mg|Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28857|NCT02458287|O1|Outcome|Bococizumab 150 mg|Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28858|NCT02458287|O2|Outcome|Bococizumab 75 mg|Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28859|NCT02458287|O1|Outcome|Bococizumab 150 mg|Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28860|NCT02458287|O4|Outcome|Bococizumab 75 mg|Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28861|NCT02458287|O3|Outcome|Placebo Matched to Bococizumab 75 mg|Participants received single dose of placebo matched to bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28862|NCT02458287|O2|Outcome|Bococizumab 150 mg|Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28863|NCT02458287|O1|Outcome|Placebo Matched to Bococizumab 150 mg|Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.
28864|NCT02458287|O4|Outcome|Bococizumab 75 mg|Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28865|NCT02458287|O3|Outcome|Placebo Matched to Bococizumab 75 mg|Participants received single dose of placebo matched to bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28866|NCT02458287|O2|Outcome|Bococizumab 150 mg|Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28867|NCT02458287|O1|Outcome|Placebo Matched to Bococizumab 150 mg|Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.
28868|NCT02458287|O4|Outcome|Bococizumab 75 mg|Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28869|NCT02458287|O3|Outcome|Placebo Matched to Bococizumab 75 mg|Participants received single dose of placebo matched to bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28870|NCT02458287|O2|Outcome|Bococizumab 150 mg|Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28871|NCT02458287|O1|Outcome|Placebo Matched to Bococizumab 150 mg|Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.
28872|NCT02458287|O4|Outcome|Bococizumab 75 mg|Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28873|NCT02458287|O3|Outcome|Placebo Matched to Bococizumab 75 mg|Participants received single dose of placebo matched to bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28874|NCT02458287|O2|Outcome|Bococizumab 150 mg|Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28875|NCT02458287|O1|Outcome|Placebo Matched to Bococizumab 150 mg|Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.
28876|NCT02458287|O2|Outcome|Bococizumab 75 mg|Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28877|NCT02458287|O1|Outcome|Placebo Matched to Bococizumab 75 mg|Participants received single dose of placebo matched to bococizumab 75 mg subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.
28878|NCT02458287|O3|Outcome|Bococizumab 150 + Bococizumab 75 mg|Participants received single dose of Bococizumab 150 mg SC injection in treatment arm Bococizumab 150 mg and Bococizumab 75 mg SC injection in treatment arm Bococizumab 75 mg, once every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28879|NCT02458287|O2|Outcome|Bococizumab 75 mg|Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28880|NCT02458287|O1|Outcome|Bococizumab 150 mg|Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28881|NCT02458287|O2|Outcome|Bococizumab 150 mg + Bococizumab 75 mg|Participants received single dose of Bococizumab 150 mg SC injection in treatment arm Bococizumab 150 mg and Bococizumab 75 mg SC injection in treatment arm Bococizumab 75 mg, once every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28882|NCT02458287|O1|Outcome|Bococizumab 75 mg|Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28883|NCT02458287|O1|Outcome|Bococizumab 150 mg|Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28884|NCT02458287|O1|Outcome|Bococizumab 150 mg|Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28885|NCT02458287|O1|Outcome|Bococizumab 150 mg|Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28990|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
28886|NCT02458287|O1|Outcome|Bococizumab 150 mg|Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28887|NCT02458287|O1|Outcome|Bococizumab 150 mg|Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28888|NCT02458287|O1|Outcome|Bococizumab 150 mg|Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28889|NCT02458287|O2|Outcome|Bococizumab 150 mg|Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28890|NCT02458287|O1|Outcome|Placebo Matched to Bococizumab 150 mg|Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.
28891|NCT02458287|E4|Reported Event|Bococizumab 75 mg|Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28892|NCT02458287|E3|Reported Event|Placebo Matched to Bococizumab 75 mg|Participants received single dose of placebo matched to bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28893|NCT02458287|E2|Reported Event|Bococizumab 150 mg|Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
28894|NCT02458287|E1|Reported Event|Placebo Matched to Bococizumab 150 mg|Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.
28895|NCT02457728|B1|Baseline|Inguinal Herniation|"In patients with bilateral herniations it should be explored if one glue device (LiquiBandFix8) for mesh fixation and closure of peritoneum is sufficient.~LiquiBandFix8: Using LiquiBandFix8 for mesh fixation and peritoneal closure following TransAbdominalPrePeritoneal (TAPP) repair."
28896|NCT02457728|P1|Participant Flow|Inguinal Herniation|"In patients with bilateral herniations it should be explored if one glue device (LiquiBandFix8) for mesh fixation and closure of peritoneum is sufficient.~LiquiBandFix8: Using LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair."
28897|NCT02457728|O1|Outcome|Single-port TAPP Repair|LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair using a single-port approach.
28898|NCT02457728|E1|Reported Event|TAPP Repair|LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair.
28899|NCT02457611|B1|Baseline|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
28900|NCT02457611|P1|Participant Flow|LDV/SOF|Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered once daily for 6 weeks
28901|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
28902|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
28903|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
28904|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
28905|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
28906|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
28907|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
28908|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
28909|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
28910|NCT02457611|E1|Reported Event|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
28911|NCT02457247|B5|Baseline|Total|Total of all reporting groups
28912|NCT02457247|B4|Baseline|Test Group 2: Sequence DC|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14, followed by, Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 15 through 28.
28913|NCT02457247|B3|Baseline|Test Group 2: Sequence CD|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14, followed by Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, once, daily, on Days 15 through 28.
28914|NCT02457247|B2|Baseline|Test Group 1: Sequence BA|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14, followed by, Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 15 through 28.
28915|NCT02457247|B1|Baseline|Test Group 1: Sequence AB|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14, followed by Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, on Days 15 through 28.
28916|NCT02457247|P4|Participant Flow|Test Group 2: Sequence DC|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14, followed by, Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 15 through 28.
28917|NCT02457247|P3|Participant Flow|Test Group 2: Sequence CD|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14, followed by Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, once, daily, on Days 15 through 28.
28918|NCT02457247|P2|Participant Flow|Test Group 1: Sequence BA|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14, followed by, Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 15 through 28.
28919|NCT02457247|P1|Participant Flow|Test Group 1: Sequence AB|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14, followed by Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, on Days 15 through 28.
29100|NCT02454127|P2|Participant Flow|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
28920|NCT02457247|O4|Outcome|Germany: Kalcipos-D|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
28921|NCT02457247|O3|Outcome|Germany: Calcichew D3 500/800|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
28922|NCT02457247|O2|Outcome|United Kingdom: Adcal-D3|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
28923|NCT02457247|O1|Outcome|United Kingdom: Calcichew D3 500/400|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
28924|NCT02457247|O4|Outcome|Germany: Kalcipos-D|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
28925|NCT02457247|O3|Outcome|Germany: Calcichew D3 500/800|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
28926|NCT02457247|O2|Outcome|United Kingdom: Adcal-D3|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
28927|NCT02457247|O1|Outcome|United Kingdom: Calcichew D3 500/400|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
28928|NCT02457247|O6|Outcome|Test Group 2: Total|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, for 14 days in either Period 1 or 2 and Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, for 14 days in either Period 1 or 2.
28929|NCT02457247|O5|Outcome|Test Group 1: Total|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, for 14 days in either Period 1 or 2 and Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, for 14 days in either Period 1 or 2.
28930|NCT02457247|O4|Outcome|Test Group 2: Sequence DC|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14, followed by, Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 15 through 28.
28931|NCT02457247|O3|Outcome|Test Group 2: Sequence CD|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14, followed by Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, once, daily, on Days 15 through 28.
28932|NCT02457247|O2|Outcome|Test Group 1: Sequence BA|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14, followed by, Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 15 through 28.
28933|NCT02457247|O1|Outcome|Test Group 1: Sequence AB|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14, followed by Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, on Days 15 through 28.
28934|NCT02457247|E4|Reported Event|Germany: Kalcipos-D|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
28935|NCT02457247|E3|Reported Event|Germany: Calcichew D3 500/800|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
28936|NCT02457247|E2|Reported Event|United Kingdom: Adcal-D3|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
28937|NCT02457247|E1|Reported Event|United Kingdom: Calcichew D3 500/400|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
28938|NCT02455518|B5|Baseline|Total|Total of all reporting groups
28939|NCT02455518|B4|Baseline|Ibuprofen/Acetaminophen|"Ibuprofen/acetaminophen (400 mg/1000 mg)~Ibuprofen/acetaminophen"
28940|NCT02455518|B3|Baseline|Codeine/Acetaminophen|"Codeine/acetaminophen (30 mg/300 mg)~Codeine/acetaminophen"
28941|NCT02455518|B2|Baseline|Hydrocodone/Acetaminophen|"Hydrocodone/acetaminophen (5 mg/300 mg)~Hydrocodone/acetaminophen"
28942|NCT02455518|B1|Baseline|Oxycodone/Acetaminophen|"Oxycodone/acetaminophen (5 mg/325 mg)~Oxycodone/acetaminophen"
28943|NCT02455518|P4|Participant Flow|Ibuprofen/Acetaminophen|"Ibuprofen/acetaminophen (400 mg/1000 mg)~Ibuprofen/acetaminophen"
28944|NCT02455518|P3|Participant Flow|Codeine/Acetaminophen|"Codeine/acetaminophen (30 mg/300 mg)~Codeine/acetaminophen"
28945|NCT02455518|P2|Participant Flow|Hydrocodone/Acetaminophen|"Hydrocodone/acetaminophen (5 mg/300 mg)~Hydrocodone/acetaminophen"
28946|NCT02455518|P1|Participant Flow|Oxycodone/Acetaminophen|"Oxycodone/acetaminophen (5 mg/325 mg)~Oxycodone/acetaminophen"
28947|NCT02455518|O4|Outcome|Ibuprofen/Acetaminophen|"Ibuprofen/acetaminophen (400 mg/1000 mg)~Ibuprofen/acetaminophen"
28948|NCT02455518|O3|Outcome|Codeine/Acetaminophen|"Codeine/acetaminophen (30 mg/300 mg)~Codeine/acetaminophen"
28949|NCT02455518|O2|Outcome|Hydrocodone/Acetaminophen|"Hydrocodone/acetaminophen (5 mg/300 mg)~Hydrocodone/acetaminophen"
28950|NCT02455518|O1|Outcome|Oxycodone/Acetaminophen|"Oxycodone/acetaminophen (5 mg/325 mg)~Oxycodone/acetaminophen"
28951|NCT02455518|O4|Outcome|Ibuprofen/Acetaminophen|"Ibuprofen/acetaminophen (400 mg/1000 mg)~Ibuprofen/acetaminophen"
28952|NCT02455518|O3|Outcome|Codeine/Acetaminophen|"Codeine/acetaminophen (30 mg/300 mg)~Codeine/acetaminophen"
28953|NCT02455518|O2|Outcome|Hydrocodone/Acetaminophen|"Hydrocodone/acetaminophen (5 mg/300 mg)~Hydrocodone/acetaminophen"
28954|NCT02455518|O1|Outcome|Oxycodone/Acetaminophen|"Oxycodone/acetaminophen (5 mg/325 mg)~Oxycodone/acetaminophen"
28955|NCT02455518|E4|Reported Event|Ibuprofen/Acetaminophen|"Ibuprofen/acetaminophen (400 mg/1000 mg)~Ibuprofen/acetaminophen"
28956|NCT02455518|E3|Reported Event|Codeine/Acetaminophen|"Codeine/acetaminophen (30 mg/300 mg)~Codeine/acetaminophen"
28957|NCT02455518|E2|Reported Event|Hydrocodone/Acetaminophen|"Hydrocodone/acetaminophen (5 mg/300 mg)~Hydrocodone/acetaminophen"
28958|NCT02455518|E1|Reported Event|Oxycodone/Acetaminophen|"Oxycodone/acetaminophen (5 mg/325 mg)~Oxycodone/acetaminophen"
28959|NCT02455050|B5|Baseline|Total|Total of all reporting groups
29101|NCT02454127|P1|Participant Flow|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
28960|NCT02455050|B4|Baseline|Genteal® Then New Eye Drop Formulation|1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
28961|NCT02455050|B3|Baseline|New Eye Drop Formulation Then Genteal®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
28962|NCT02455050|B2|Baseline|Systane® Then New Eye Drop Formulation|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
28963|NCT02455050|B1|Baseline|New Eye Drop Formulation Then Systane®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Systane® in each eye as needed at least 2 times daily for 2 weeks in Period 2.
28964|NCT02455050|P4|Participant Flow|Genteal® Then New Eye Drop Formulation|1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
28965|NCT02455050|P3|Participant Flow|New Eye Drop Formulation Then Genteal®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
28966|NCT02455050|P2|Participant Flow|Systane® Then New Eye Drop Formulation|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
28967|NCT02455050|P1|Participant Flow|New Eye Drop Formulation Then Systane®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Systane® in each eye as needed at least 2 times daily for 2 weeks in Period 2.
28968|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
28969|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
28970|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
28971|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
28972|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
28973|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
28974|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
28975|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
28976|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
28977|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
28978|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
28979|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
28980|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
28981|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
28982|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
28983|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
28984|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
28985|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
28986|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
28987|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
28988|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
28989|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
30227|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
28991|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
28992|NCT02455050|O1|Outcome|New Eye Drop Formulation and Genteal®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2 and 1 to 2 drops of Genteal® in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
28993|NCT02455050|O1|Outcome|New Eye Drop Formulation and Systane®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2 and 1 to 2 drops of Systane® in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
28994|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
28995|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
28996|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
28997|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
28998|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
28999|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
29000|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
29001|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
29002|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
29003|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
29004|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
29005|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
29006|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
29007|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
29008|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
29009|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
29010|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
29011|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
29012|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
29013|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
29014|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
29015|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
29016|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
29017|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
29018|NCT02455050|O4|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
29019|NCT02455050|O3|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
29020|NCT02455050|O2|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
29021|NCT02455050|O1|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
29022|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.
29023|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1.
29024|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.
29025|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1.
29026|NCT02455050|E4|Reported Event|Genteal® Then New Eye Drop Formulation|1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
29027|NCT02455050|E3|Reported Event|New Eye Drop Formulation Then Genteal®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
29028|NCT02455050|E2|Reported Event|Systane® Then New Eye Drop Formulation|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
29029|NCT02455050|E1|Reported Event|New Eye Drop Formulation Then Systane®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Systane® in each eye as needed at least 2 times daily for 2 weeks in Period 2.
29030|NCT02454959|B1|Baseline|MITT Population|The Modified ITT (MITT) Population is a subset of the ITT Population including subjects who received treatment and had post dose efficacy data from both Treatment Periods. Data judged to be impacted by major protocol deviations were determined prior to unblinding and excluded. Statistical tabulations and analyses are by randomized treatment, but data obtained after subjects received an incorrect treatment have been excluded from the affected periods.
29031|NCT02454959|P1|Participant Flow|Overall Study|All Randomized Patients
29032|NCT02454959|O2|Outcome|GFF MDI (PT003) Without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber
29033|NCT02454959|O1|Outcome|GFF MDI (PT003) With Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber
29034|NCT02454959|O2|Outcome|GFF MDI (PT003) Without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber
29035|NCT02454959|O1|Outcome|GFF MDI (PT003) With Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber
29036|NCT02454959|O2|Outcome|GFF MDI (PT003) Without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber
29037|NCT02454959|O1|Outcome|GFF MDI (PT003) With Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber
29038|NCT02454959|O2|Outcome|GFF MDI (PT003) Without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber
29039|NCT02454959|O1|Outcome|GFF MDI (PT003) With Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber
29040|NCT02454959|O2|Outcome|GFF MDI (PT003) Without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber
29041|NCT02454959|O1|Outcome|GFF MDI (PT003) With Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber
29042|NCT02454959|O2|Outcome|GFF MDI (PT003) Without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber
29043|NCT02454959|O1|Outcome|GFF MDI (PT003) With Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber
29044|NCT02454959|O2|Outcome|GFF MDI (PT003) Without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber
29045|NCT02454959|O1|Outcome|GFF MDI (PT003) With Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber
29046|NCT02454959|E2|Reported Event|GFF MDI (PT003) Without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber
29047|NCT02454959|E1|Reported Event|GFF MDI (PT003) With Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber
29048|NCT02454608|B3|Baseline|Total|Total of all reporting groups
29049|NCT02454608|B2|Baseline|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
29050|NCT02454608|B1|Baseline|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
29051|NCT02454608|P2|Participant Flow|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
29102|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
29103|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
29104|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
29105|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
29106|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
29052|NCT02454608|P1|Participant Flow|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
29053|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
29054|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
29055|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
29056|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
29057|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
29058|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
29059|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
29060|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
29061|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
29062|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
29063|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
29064|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
29065|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
29107|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
29108|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
29109|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
30762|NCT02442349|E1|Reported Event|AZD9291 80mg|Daily single dose of AZD9291 80mg
29066|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
29067|NCT02454608|E2|Reported Event|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
29068|NCT02454608|E1|Reported Event|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
29069|NCT02454296|B3|Baseline|Total|Total of all reporting groups
29070|NCT02454296|B2|Baseline|Sham Block Group|Participants in this arm had a 20 ml syringe with a capped needle applied to the cervix.
29071|NCT02454296|B1|Baseline|Paracervical Block Group|Participants in this arm received a paracervical block consisting of 18 ml 1% lidocaine and 2 ml 8.4% sodium bicarbonate prior to the placement of laminaria.
29072|NCT02454296|P2|Participant Flow|Sham Paracervical Block|"A sham block will be done prior to the placement of laminaria using a capped needle~Sham paracervical block: A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes"
29073|NCT02454296|P1|Participant Flow|Paracervical Block With Lidocaine|"A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate.~Paracervical Block with lidocaine: Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion"
29074|NCT02454296|O2|Outcome|Sham Block Group|Participants in this arm had a 20 ml syringe with a capped needle applied to the cervix.
29075|NCT02454296|O1|Outcome|Paracervical Block Group|Participants in this arm received a paracervical block consisting of 18 ml 1% lidocaine and 2 ml 8.4% sodium bicarbonate prior to the placement of laminaria.
29076|NCT02454296|O2|Outcome|Sham Block Group|Participants in this arm had a 20 ml syringe with a capped needle applied to the cervix.
29077|NCT02454296|O1|Outcome|Paracervical Block Group|Participants in this arm received a paracervical block consisting of 18 ml 1% lidocaine and 2 ml 8.4% sodium bicarbonate prior to the placement of laminaria.
29078|NCT02454296|O2|Outcome|Sham Paracervical Block|"A sham block will be done prior to the placement of laminaria using a capped needle~Sham paracervical block: A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes"
29079|NCT02454296|O1|Outcome|Paracervical Block With Lidocaine|"A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate.~Paracervical Block with lidocaine: Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion"
29080|NCT02454296|E2|Reported Event|Sham Paracervical Block|"A sham block will be done prior to the placement of laminaria using a capped needle~Sham paracervical block: A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes"
29081|NCT02454296|E1|Reported Event|Paracervical Block With Lidocaine|"A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate.~Paracervical Block with lidocaine: Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion"
29082|NCT02454283|B3|Baseline|Total|Total of all reporting groups
29083|NCT02454283|B2|Baseline|Placebo|"identically matching placebo capsules, orally, single-dose~Placebo"
29084|NCT02454283|B1|Baseline|Vanoxerine HCl|"Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose~Vanoxerine HCl"
29085|NCT02454283|P2|Participant Flow|Placebo|"identically matching placebo capsules, orally, single-dose~Placebo"
29086|NCT02454283|P1|Participant Flow|Vanoxerine HCl|"Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose~Vanoxerine HCl"
29087|NCT02454283|O2|Outcome|Placebo|"identically matching placebo capsules, orally, single-dose~Placebo"
29088|NCT02454283|O1|Outcome|Vanoxerine HCl|"Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose~Vanoxerine HCl"
29089|NCT02454283|O2|Outcome|Placebo|"identically matching placebo capsules, orally, single-dose~Placebo"
29090|NCT02454283|O1|Outcome|Vanoxerine HCl|"Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose~Vanoxerine HCl"
29091|NCT02454283|E2|Reported Event|Placebo|"identically matching placebo capsules, orally, single-dose~Placebo"
29092|NCT02454283|E1|Reported Event|Vanoxerine HCl|"Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose~Vanoxerine HCl"
29093|NCT02454127|B5|Baseline|Total|Total of all reporting groups
29094|NCT02454127|B4|Baseline|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
29095|NCT02454127|B3|Baseline|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
29096|NCT02454127|B2|Baseline|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
29097|NCT02454127|B1|Baseline|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
29098|NCT02454127|P4|Participant Flow|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
29099|NCT02454127|P3|Participant Flow|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
29111|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
29112|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
29113|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
29114|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
29115|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
29116|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
29117|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
29118|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
29119|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
29120|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
29121|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
29122|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
29123|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
29124|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
29125|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
29126|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
29127|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
29128|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
29129|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
29130|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
29131|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
29132|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
29133|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
29134|NCT02454127|E4|Reported Event|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
29135|NCT02454127|E3|Reported Event|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
29136|NCT02454127|E2|Reported Event|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
29137|NCT02454127|E1|Reported Event|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
29138|NCT02454101|B3|Baseline|Total|Total of all reporting groups
29139|NCT02454101|B2|Baseline|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
29140|NCT02454101|B1|Baseline|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
29141|NCT02454101|P2|Participant Flow|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
29142|NCT02454101|P1|Participant Flow|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
29143|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
29144|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
29145|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
29146|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
29147|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
29148|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
29149|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
29150|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
29151|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
29152|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
29153|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
29154|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
29155|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
29156|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
29157|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
29158|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
31212|NCT02436304|O3|Outcome|Tubes Only|Bilateral myringotomy and tympanostomy tube insertion
29159|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
29160|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
29161|NCT02454101|E2|Reported Event|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
29162|NCT02454101|E1|Reported Event|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
29163|NCT02453581|B1|Baseline|Randomised Participants|Twenty-four male and female subjects were enrolled in the study.
29164|NCT02453581|P3|Participant Flow|OZ439 500mg|OZ439 500mg Powder for Oral Suspension
29165|NCT02453581|P2|Participant Flow|OZ439 200mg|OZ439 200mg Powder for Oral Suspension
29166|NCT02453581|P1|Participant Flow|OZ439 100mg|OZ439 100mg Powder for Oral Suspension
29167|NCT02453581|O1|Outcome|OZ439 500mg Arm|Cohort 3 - OZ439 500mg
29168|NCT02453581|O3|Outcome|OZ439 500mg|OZ439 500mg Powder for Oral Suspension
29169|NCT02453581|O2|Outcome|OZ439 200mg|OZ439 200mg Powder for Oral Suspension
29170|NCT02453581|O1|Outcome|OZ439 100mg|OZ439 100mg Powder for Oral Suspension
29171|NCT02453581|O3|Outcome|OZ439 500mg|OZ439 500mg Powder for Oral Suspension
29172|NCT02453581|O2|Outcome|OZ439 200mg|OZ439 200mg Powder for Oral Suspension
29173|NCT02453581|O1|Outcome|OZ439 100mg|OZ439 100mg Powder for Oral Suspension
29174|NCT02453581|O8|Outcome|OZ439 500mg - R024|Cohort 3 - OZ439 500mg - Subject R024
29175|NCT02453581|O7|Outcome|OZ439 500mg - R023|Cohort 3 - OZ439 500mg - Subject R023
29176|NCT02453581|O6|Outcome|OZ439 500mg - R022|Cohort 3 - OZ439 500mg - Subject R022
29177|NCT02453581|O5|Outcome|OZ439 500mg - R021|Cohort 3 - OZ439 500mg - Subject R021
29178|NCT02453581|O4|Outcome|OZ439 500mg - R020|Cohort 3 - OZ439 500mg - Subject R020
29179|NCT02453581|O3|Outcome|OZ439 500mg - R019|Cohort 3 - OZ439 500mg - Subject R019
29180|NCT02453581|O2|Outcome|OZ439 500mg - R018|Cohort 3 - OZ439 500mg - Subject R018
29181|NCT02453581|O1|Outcome|OZ439 500mg - R017|Cohort 3 - OZ439 500mg - Subject R017
29182|NCT02453581|E3|Reported Event|OZ439 500mg|OZ439 500mg Powder for Oral Suspension
29183|NCT02453581|E2|Reported Event|OZ439 200mg|OZ439 200mg Powder for Oral Suspension
29184|NCT02453581|E1|Reported Event|OZ439 100mg|OZ439 100mg Powder for Oral Suspension
29185|NCT02453347|B1|Baseline|CES Therapy|"All participants will complete CES treatment over the course of four weeks. Assessments will take place at baseline and at post-test four weeks later.~CES Therapy: Cranial Electrotherapy Stimulation (CES) may serve as an effective complimentary, noninvasive/non-pharmacological treatment for this Veteran population. CES is administered through a therapeutic device (such as Alpha-Stim®) marketed and approved by the FDA to treat insomnia, depression, anxiety, and pain."
29186|NCT02453347|P1|Participant Flow|CES Therapy|"All participants will complete CES treatment over the course of four weeks. Assessments will take place at baseline and at post-test four weeks later.~CES Therapy: Cranial Electrotherapy Stimulation (CES) may serve as an effective complimentary, noninvasive/non-pharmacological treatment for this Veteran population. CES is administered through a therapeutic device (such as Alpha-Stim®) marketed and approved by the FDA to treat insomnia, depression, anxiety, and pain."
29187|NCT02453347|O1|Outcome|CES Therapy|"All participants will complete CES treatment over the course of four weeks. Assessments will take place at baseline and at post-test four weeks later.~CES Therapy: Cranial Electrotherapy Stimulation (CES) may serve as an effective complimentary, noninvasive/non-pharmacological treatment for this Veteran population. CES is administered through a therapeutic device (such as Alpha-Stim®) marketed and approved by the FDA to treat insomnia, depression, anxiety, and pain."
29188|NCT02453347|O1|Outcome|CES Therapy|"All participants will complete CES treatment over the course of four weeks. Assessments will take place at baseline and at post-test four weeks later.~CES Therapy: Cranial Electrotherapy Stimulation (CES) may serve as an effective complimentary, noninvasive/non-pharmacological treatment for this Veteran population. CES is administered through a therapeutic device (such as Alpha-Stim®) marketed and approved by the FDA to treat insomnia, depression, anxiety, and pain."
29189|NCT02453347|O1|Outcome|CES Therapy|"All participants will complete CES treatment over the course of four weeks. Assessments will take place at baseline and at post-test four weeks later.~CES Therapy: Cranial Electrotherapy Stimulation (CES) may serve as an effective complimentary, noninvasive/non-pharmacological treatment for this Veteran population. CES is administered through a therapeutic device (such as Alpha-Stim®) marketed and approved by the FDA to treat insomnia, depression, anxiety, and pain."
29190|NCT02453347|O1|Outcome|CES Therapy|"All participants will complete CES treatment over the course of four weeks. Assessments will take place at baseline and at post-test four weeks later.~CES Therapy: Cranial Electrotherapy Stimulation (CES) may serve as an effective complimentary, noninvasive/non-pharmacological treatment for this Veteran population. CES is administered through a therapeutic device (such as Alpha-Stim®) marketed and approved by the FDA to treat insomnia, depression, anxiety, and pain."
29191|NCT02453347|O1|Outcome|CES Therapy|"All participants will complete CES treatment over the course of four weeks. Assessments will take place at baseline and at post-test four weeks later.~CES Therapy: Cranial Electrotherapy Stimulation (CES) may serve as an effective complimentary, noninvasive/non-pharmacological treatment for this Veteran population. CES is administered through a therapeutic device (such as Alpha-Stim®) marketed and approved by the FDA to treat insomnia, depression, anxiety, and pain."
29192|NCT02453347|O1|Outcome|CES Therapy|"All participants will complete CES treatment over the course of four weeks. Assessments will take place at baseline and at post-test four weeks later.~CES Therapy: Cranial Electrotherapy Stimulation (CES) may serve as an effective complimentary, noninvasive/non-pharmacological treatment for this Veteran population. CES is administered through a therapeutic device (such as Alpha-Stim®) marketed and approved by the FDA to treat insomnia, depression, anxiety, and pain."
29290|NCT02452528|O2|Outcome|Placebo|"Intravenous administration of normal saline (0.9%) once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of placebo."
31282|NCT02435277|E1|Reported Event|FDC 125|Leucine 1100mg +Metformin 125mg
29193|NCT02453347|O1|Outcome|CES Therapy|"All participants will complete CES treatment over the course of four weeks. Assessments will take place at baseline and at post-test four weeks later.~CES Therapy: Cranial Electrotherapy Stimulation (CES) may serve as an effective complimentary, noninvasive/non-pharmacological treatment for this Veteran population. CES is administered through a therapeutic device (such as Alpha-Stim®) marketed and approved by the FDA to treat insomnia, depression, anxiety, and pain."
29194|NCT02453347|O1|Outcome|CES Therapy|"All participants will complete CES treatment over the course of four weeks. Assessments will take place at baseline and at post-test four weeks later.~CES Therapy: Cranial Electrotherapy Stimulation (CES) may serve as an effective complimentary, noninvasive/non-pharmacological treatment for this Veteran population. CES is administered through a therapeutic device (such as Alpha-Stim®) marketed and approved by the FDA to treat insomnia, depression, anxiety, and pain."
29195|NCT02453347|O1|Outcome|CES Therapy|"All participants will complete CES treatment over the course of four weeks. Assessments will take place at baseline and at post-test four weeks later.~CES Therapy: Cranial Electrotherapy Stimulation (CES) may serve as an effective complimentary, noninvasive/non-pharmacological treatment for this Veteran population. CES is administered through a therapeutic device (such as Alpha-Stim®) marketed and approved by the FDA to treat insomnia, depression, anxiety, and pain."
29196|NCT02453347|O1|Outcome|CES Therapy|"All participants will complete CES treatment over the course of four weeks. Assessments will take place at baseline and at post-test four weeks later.~CES Therapy: Cranial Electrotherapy Stimulation (CES) may serve as an effective complimentary, noninvasive/non-pharmacological treatment for this Veteran population. CES is administered through a therapeutic device (such as Alpha-Stim®) marketed and approved by the FDA to treat insomnia, depression, anxiety, and pain."
29197|NCT02453347|E1|Reported Event|CES Therapy|"All participants will complete CES treatment over the course of four weeks. Assessments will take place at baseline and at post-test four weeks later.~CES Therapy: Cranial Electrotherapy Stimulation (CES) may serve as an effective complimentary, noninvasive/non-pharmacological treatment for this Veteran population. CES is administered through a therapeutic device (such as Alpha-Stim®) marketed and approved by the FDA to treat insomnia, depression, anxiety, and pain."
29198|NCT02453321|B4|Baseline|Total|Total of all reporting groups
29199|NCT02453321|B3|Baseline|Continuous Adductor Canal|"Placed at mid-thigh in proximal adductor canal near femoral artery with a bupivacaine infusion rate of 4ml/hr. Hypothesis is that this group may experience less motor blockade of thigh but may have more pain than the femoral nerve groups.~Nerve Block, Continuous Adductor Canal: A 27g plastic catheter placed on the antero-medial thigh midway between the groin and knee to provide a local anesthetic conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: T"
29200|NCT02453321|B2|Baseline|Cont. Femoral Block - Higher Dose|"Place the CPNB in same manner as low-dose group, but rate will be 4ml/hr. Hypothesis is that this group may experience better pain control, but likely will have more dense motor blockade of thigh and less participation in physical therapy~Continuous Femoral Nerve Block: A 27g plastic catheter inserted below the inguinal crease to cause conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: The concentration of the continuous infusion of bupivacaine tho"
29201|NCT02453321|B1|Baseline|Cont. Femoral Block - Low Dose Group|"Arm is named by the intervention received... Continuous Femoral Block - Low Dose. The Block/catheter is placed about 5cm below groin at ultrasonographic apex of femoral triangle. Rate of 2ml/hr of bupivacaine 0.0625% until morning of POD#2.~Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease intended to block the sensory nerves to decrease pain in the knee after TKA.~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It is only dosed postoperatively after verifying sciatic nerve function is intact. The infusion is 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: The concentration of the infusions of bupivacaine in peripheral nerve catheters will be 0.0625% for the femoral and adductor canal, and"
29202|NCT02453321|P3|Participant Flow|Continuous Adductor Canal|"Placed at mid-thigh in proximal adductor canal near femoral artery with a bupivacaine infusion rate of 4ml/hr. Hypothesis: This group may experience less motor blockade of thigh but may have more pain than the femoral nerve groups.~Nerve Block, Continuous Adductor Canal: A 27g plastic catheter placed on the anterior medial thigh midway between the groin and knee to provide a local anesthetic conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: T"
29236|NCT02452892|P4|Participant Flow|LFMS 120 Min|"Week 2: Subjects may be re-randomized to receive LFMS 120 minutes. Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~Week 1 subjects were randomly assigned using 1:1:1 allocation to LFMS Sham, LFMS 20 min., or LFMS 60 min. For Week 2 subjects were reassigned to LFMS Sham, LFMS 20min, LFMS 60min, or LFMS 120min. on the basis of their response to treatment received in Week 1 and their original treatment allocation."
29291|NCT02452528|O1|Outcome|ARC-520|"Intravenous administration of 1.0 mg/kg ARC-520 once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of study drug."
29203|NCT02453321|P2|Participant Flow|Cont. Femoral Block - Higher Dose|"Place the Continuous Peripheral Nerve Block (CPNB) in same manner as low-dose group, with increased rate of 4ml/hr. Hypothesis is that this group may experience better pain control, but more motor blockade of thigh and less participation in physical therapy is likely.~Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform blockade of the sensory components of the femoral nerve to decrease pain in the knee after TKA.~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: The concentration of the continuous infusion of bupivacaine tho"
29204|NCT02453321|P1|Participant Flow|Cont. Femoral Block - Low Dose Group|"Continuous Femoral Block - Low Dose Intervention Group. The Block/catheter is placed about 5cm below groin at ultrasonographic apex of femoral triangle. Rate of 2ml/hr of bupivacaine 0.0625% until morning of Postoperative Day (POD) #2.~Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: The concentration of the continuous infusion of bupi"
29205|NCT02453321|O3|Outcome|Continuous Adductor Canal|"Placed at mid-thigh in proximal adductor canal near femoral artery with a bupivacaine infusion rate of 4ml/hr. Hypothesis: This group may experience less motor blockade of thigh but may have more pain than the femoral nerve groups.~Nerve Block, Continuous Adductor Canal: A 27g plastic catheter placed on the anterior medial thigh midway between the groin and knee to provide a local anesthetic conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: T"
29206|NCT02453321|O2|Outcome|Cont. Femoral Block - Higher Dose|"Place the CPNB in same manner as low-dose group, but rate will be 4ml/hr. Hypothesis is that this group may experience better pain control, but likely will have more motor blockade of thigh and less participation in physical therapy~Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: The concentration of the continuous infusion of bupivacaine tho"
29207|NCT02453321|O1|Outcome|Cont. Femoral Block - Low Dose Group|"Arm is named by the intervention... Continuous Femoral Block - Low Dose. The Block/catheter is placed about 5cm below groin at ultrasonographic apex of femoral triangle. Rate of 2ml/hr of bupivacaine 0.0625% until morning of POD#2.~Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: The concentration of the continuous infusion of bupi"
29208|NCT02453321|O3|Outcome|Continuous Adductor Canal|"Placed at mid-thigh in proximal adductor canal near femoral artery with a bupivacaine infusion rate of 4ml/hr. Hypothesis: This group may experience less motor blockade of thigh but may have more pain than the femoral nerve groups.~Nerve Block, Continuous Adductor Canal: A 27g plastic catheter placed on the anterior medial thigh midway between the groin and knee to provide a local anesthetic conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: T"
29209|NCT02453321|O2|Outcome|Cont. Femoral Block - Higher Dose|"Place the CPNB in same manner as low-dose group, but rate will be 4ml/hr. Hypothesis is that this group may experience better pain control, but likely will have more motor blockade of thigh and less participation in physical therapy~Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: The concentration of the continuous infusion of bupivacaine tho"
29237|NCT02452892|P3|Participant Flow|LFMS 60 Minutes|"LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~Week 1: Subjects were randomly assigned using 1:1:1 allocation to LFMS Sham, LFMS 20 min., or LFMS 60 min. For Week 2 subjects were reassigned to LFMS Sham, LFMS 20min, LFMS 60min, or LFMS 120min. on the basis of their response to treatment received in Week 1 and their original treatment allocation."
29210|NCT02453321|O1|Outcome|Cont. Femoral Block - Low Dose Group|"Arm is named by the intervention... Continuous Femoral Block - Low Dose. The Block/catheter is placed about 5cm below groin at ultrasonographic apex of femoral triangle. Rate of 2ml/hr of bupivacaine 0.0625% until morning of POD#2.~Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: The concentration of the continuous infusion of bupi"
29211|NCT02453321|O3|Outcome|Continuous Adductor Canal|"Placed at mid-thigh in proximal adductor canal near femoral artery with a bupivacaine infusion rate of 4ml/hr. Hypothesis: This group may experience less motor blockade of thigh but may have more pain than the femoral nerve groups.~Nerve Block, Continuous Adductor Canal: A 27g plastic catheter placed on the anterior medial thigh midway between the groin and knee to provide a local anesthetic conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: T"
29212|NCT02453321|O2|Outcome|Cont. Femoral Block - Higher Dose|"Place the CPNB in same manner as low-dose group, but rate will be 4ml/hr. Hypothesis is that this group may experience better pain control, but likely will have more motor blockade of thigh and less participation in physical therapy~Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: The concentration of the continuous infusion of bupivacaine tho"
29213|NCT02453321|O1|Outcome|Cont. Femoral Block - Low Dose Group|"Arm is named by the intervention... Continuous Femoral Block - Low Dose. The Block/catheter is placed about 5cm below groin at ultrasonographic apex of femoral triangle. Rate of 2ml/hr of bupivacaine 0.0625% until morning of POD#2.~Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: The concentration of the continuous infusion of bupi"
29214|NCT02453321|O3|Outcome|Continuous Adductor Canal|"Placed at mid-thigh in proximal adductor canal near femoral artery with a bupivacaine infusion rate of 4ml/hr. Hypothesis is that this group may experience less motor blockade of thigh but may have more pain than the femoral nerve groups.~Nerve Block, Continuous Adductor Canal: A 27g plastic catheter placed on the antero- medial thigh midway between the groin and knee to provide a local anesthetic conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: T"
29215|NCT02453321|O2|Outcome|Cont. Femoral Block - Higher Dose|"Place the CPNB in same manner as low-dose group, but rate to be 4ml/hr. Hypothesis is that this group may experience better pain control, but likely will have more dense motor blockade of thigh and less participation in physical therapy~Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: The concentration of the continuous infusion of bupivacaine tho"
29216|NCT02453321|O1|Outcome|Cont. Femoral Block - Low Dose Group|"Arm is named by the intervention received.. Continuous Femoral Block - Low Dose. The Block/catheter is placed about 5cm below groin at ultrasonographic apex of femoral triangle. Rate of 2ml/hr of bupivacaine 0.0625% until morning of POD#2.~Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: The concentration of the continuous infusion of bupi"
29238|NCT02452892|P2|Participant Flow|LFMS 20 Minutes|"LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~Week 1 subjects were randomly assigned using 1:1:1 allocation to LFMS Sham, LFMS 20 min., or LFMS 60 min. For Week 2, subjects were reassigned to LFMS Sham, LFMS 20min, LFMS 60min, or LFMS 120min. on the basis of their response to treatment received in Week 1 and their original treatment allocation."
29217|NCT02453321|E3|Reported Event|Continuous Adductor Canal|"Placed at mid-thigh in proximal adductor canal near femoral artery with a bupivacaine infusion rate of 4ml/hr. Hypothesis is that this group may experience less motor blockade of thigh but may have more pain than the femoral nerve groups.~Nerve Block, Continuous Adductor Canal: A 27g plastic catheter placed on the anterior-medial thigh midway between the Anterior Superior Iliac Spine (ASIS) and patella. Intent is to block sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty.~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: T"
29218|NCT02453321|E2|Reported Event|Cont. Femoral Block - Higher Dose|"CFNB placed in same manner as low-dose group, but rate will be higher (4ml/hr). Hypothesis is this group may experience better pain control, but likely will have more motor blockade of thigh and less participation in physical therapy.~CFNB: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: The concentration of the continuous infusion of bupivacaine tho"
29219|NCT02453321|E1|Reported Event|Cont. Femoral Block - Low Dose Group|"Continuous Femoral Nerve Block (CFNB) -Low dose. The Block/catheter is placed about 5cm below groin usually corresponding with the ultrasonographic apex of femoral triangle. Rate of 2ml/hr of bupivacaine 0.0625% until morning of POD#2.~CFNB: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty~Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.~Bupivacaine: The concentration of the continuous infusion of bupivacaine is 0.0625%"
29220|NCT02452944|B3|Baseline|Total|Total of all reporting groups
29221|NCT02452944|B2|Baseline|US-NS Group|ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at 0.3mA, 10mL of local anesthetics was injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected.
29222|NCT02452944|B1|Baseline|US-IFI Group|"ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)~The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus, another 5mL of LA was injected.~After that, the needle was reinserted to the same spots attached with nerve stimulator at 1.0 mA. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as ‘fail’."
29223|NCT02452944|P2|Participant Flow|US-NS Group|"ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group)~The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at the stimulation current 0.3mA, 10mL of local anesthetics (LA;1.5% lidocaine + epi 1:200,000) were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected."
29224|NCT02452944|P1|Participant Flow|US-IFI Group|"ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)~The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis muscles. 10mL of local anesthetics (LA; 1.5% lidocaine + epi 1:200,000) were injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus muscles, another 5mL of LA was injected.~After that, the needle was reinserted to the same spots attached with nerve stimulator for confirming the block. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as ‘fail’."
29225|NCT02452944|O2|Outcome|US-NS Group|ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at 0.3mA, 10mL of local anesthetics were injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected.
29239|NCT02452892|P1|Participant Flow|LFMS Sham|For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.Week 1 subjects were randomly assigned using 1:1:1 allocation to LFMS Sham, LFMS 20 min., or LFMS 60 min. For Week 2 subjects were reassigned to LFMS Sham, LFMS 20min, LFMS 60min, or LFMS 120min. on the basis of their response to treatment received in Week 1 and their original treatment allocation.
29292|NCT02452528|O2|Outcome|Placebo|"Intravenous administration of normal saline (0.9%) once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of placebo."
29226|NCT02452944|O1|Outcome|US-IFI Group|"ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)~The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus, another 5mL of LA was injected.~After that, the needle was reinserted to the same spots attached with nerve stimulator at 1.0 mA. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as ‘fail’.~nerve stimulator (stimuplex HNS12): whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block~ultrasound: we did obturator nerve block with ultrasound guided method for searching the fascias where the anterior and posterior branches of obturator nerve run."
29227|NCT02452944|O2|Outcome|US-NS Group|"ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and adductor brevis. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at the stimulation current 0.3mA, 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected.~nerve stimulator (stimuplex HNS12): whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block~ultrasound: we did obturator nerve block with ultrasound guided m"
29228|NCT02452944|O1|Outcome|US-IFI Group|"ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)~The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and adductor brevis. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles, another 5mL of LA was injected.~After that, the needle was reinserted to the same spots attached with nerve stimulator at 1.0 mA. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as ‘fail’.~nerve stimulator (stimuplex HNS12): whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block~ultrasound: we did obturator nerve block with ultrasound guided method for searching the fascias where the anterior and posterior branches of obturator nerv"
29229|NCT02452944|E2|Reported Event|US-NS Group|ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and adductor brevis muscles. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at the stimulation current 0.3mA, 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected.
29230|NCT02452944|E1|Reported Event|US-IFI Group|"ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)~The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles, another 5mL of LA was injected.~After that, the needle was reinserted to the same spots attached with nerve stimulator at 1.0 mA. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as ‘fail’.~nerve stimulator (stimuplex HNS12): whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block~ultrasound: we did obturator nerve block with ultrasound guided method for searching the fascias where the anterior and posterior branches of obturator nerve run."
29231|NCT02452892|B5|Baseline|Total|Total of all reporting groups
29232|NCT02452892|B4|Baseline|LFMS 120 Min|"Week 2 subjects may be re-randomized to receive LFMS 120 minutes. Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29233|NCT02452892|B3|Baseline|LFMS 60 Minutes|"LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29234|NCT02452892|B2|Baseline|LFMS 20 Minutes|"LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29235|NCT02452892|B1|Baseline|LFMS Sham|"For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29289|NCT02452528|O1|Outcome|ARC-520|"Intravenous administration of 1.0 mg/kg ARC-520 once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of study drug."
29417|NCT02451150|E1|Reported Event|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
29240|NCT02452892|O3|Outcome|LFMS 60 Minutes|"LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29241|NCT02452892|O2|Outcome|LFMS 20 Minutes|"LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29242|NCT02452892|O1|Outcome|LFMS Sham|"For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29243|NCT02452892|O3|Outcome|LFMS 60 Minutes|"LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29244|NCT02452892|O2|Outcome|LFMS 20 Minutes|"LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29245|NCT02452892|O1|Outcome|LFMS Sham|"For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29246|NCT02452892|O3|Outcome|LFMS 60 Minutes|"LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29247|NCT02452892|O2|Outcome|LFMS 20 Minutes|"LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29248|NCT02452892|O1|Outcome|LFMS Sham|"For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29249|NCT02452892|O3|Outcome|LFMS 60 Minutes|"LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29250|NCT02452892|O2|Outcome|LFMS 20 Minutes|"LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29251|NCT02452892|O1|Outcome|LFMS Sham|"For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29252|NCT02452892|O3|Outcome|LFMS 60 Minutes|"LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29363|NCT02451358|E2|Reported Event|Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years|Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.
29253|NCT02452892|O2|Outcome|LFMS 20 Minutes|"LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29254|NCT02452892|O1|Outcome|LFMS Sham|"For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29255|NCT02452892|O3|Outcome|LFMS Sham|"For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29256|NCT02452892|O2|Outcome|LFMS 60 Minutes|"LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29257|NCT02452892|O1|Outcome|LFMS 20 Minutes|"LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29258|NCT02452892|O2|Outcome|LFMS 120 Min|"Week 2 subjects may be re-randomized to receive LFMS 120 minutes. Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29259|NCT02452892|O1|Outcome|LFMS Sham|"For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29260|NCT02452892|O3|Outcome|LFMS 60 Minutes|"LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29261|NCT02452892|O2|Outcome|LFMS 20 Minutes|"LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29262|NCT02452892|O1|Outcome|LFMS Sham|"For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29263|NCT02452892|E4|Reported Event|LFMS 120 Min - Week 2|"Week 2 subjects may be re-randomized to receive LFMS 120 minutes. Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29264|NCT02452892|E3|Reported Event|LFMS 60 Minutes|"LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29265|NCT02452892|E2|Reported Event|LFMS 20 Minutes|"LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29415|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
29266|NCT02452892|E1|Reported Event|LFMS Sham|"For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.~LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered."
29267|NCT02452528|B3|Baseline|Total|Total of all reporting groups
29268|NCT02452528|B2|Baseline|Placebo|"Intravenous administration of normal saline (0.9%) once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of placebo."
29269|NCT02452528|B1|Baseline|ARC-520|"Intravenous administration of 1.0 mg/kg ARC-520 once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of study drug."
29270|NCT02452528|P2|Participant Flow|Placebo|"Intravenous administration of normal saline (0.9%) once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of placebo."
29271|NCT02452528|P1|Participant Flow|ARC-520|"Intravenous administration of 1.0 mg/kg ARC-520 once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of study drug."
29272|NCT02452528|O2|Outcome|Placebo|"Intravenous administration of normal saline (0.9%) once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of placebo."
29273|NCT02452528|O1|Outcome|ARC-520|"Intravenous administration of 1.0 mg/kg ARC-520 once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of study drug."
29274|NCT02452528|O2|Outcome|Placebo|"Intravenous administration of normal saline (0.9%) once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of placebo."
29275|NCT02452528|O1|Outcome|ARC-520|"Intravenous administration of 1.0 mg/kg ARC-520 once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of study drug."
29276|NCT02452528|O2|Outcome|Placebo|"Intravenous administration of normal saline (0.9%) once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of placebo."
29277|NCT02452528|O1|Outcome|ARC-520|"Intravenous administration of 1.0 mg/kg ARC-520 once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of study drug."
29278|NCT02452528|O2|Outcome|Placebo|"Intravenous administration of normal saline (0.9%) once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of placebo."
29279|NCT02452528|O1|Outcome|ARC-520|"Intravenous administration of 1.0 mg/kg ARC-520 once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of study drug."
29280|NCT02452528|O2|Outcome|Placebo|"Intravenous administration of normal saline (0.9%) once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of placebo."
29281|NCT02452528|O1|Outcome|ARC-520|"Intravenous administration of 1.0 mg/kg ARC-520 once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of study drug."
29282|NCT02452528|O2|Outcome|Placebo|"Intravenous administration of normal saline (0.9%) once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of placebo."
29283|NCT02452528|O1|Outcome|ARC-520|"Intravenous administration of 1.0 mg/kg ARC-520 once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of study drug."
29284|NCT02452528|O2|Outcome|Placebo|"Intravenous administration of normal saline (0.9%) once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of placebo."
29285|NCT02452528|O1|Outcome|ARC-520|"Intravenous administration of 1.0 mg/kg ARC-520 once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of study drug."
29286|NCT02452528|O2|Outcome|Placebo|"Intravenous administration of normal saline (0.9%) once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of placebo."
29287|NCT02452528|O1|Outcome|ARC-520|"Intravenous administration of 1.0 mg/kg ARC-520 once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of study drug."
29288|NCT02452528|O2|Outcome|Placebo|"Intravenous administration of normal saline (0.9%) once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of placebo."
29418|NCT02450799|B4|Baseline|Total|Total of all reporting groups
29293|NCT02452528|O1|Outcome|ARC-520|"Intravenous administration of 1.0 mg/kg ARC-520 once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of study drug."
29294|NCT02452528|O2|Outcome|Placebo|"Intravenous administration of normal saline (0.9%) once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of placebo."
29295|NCT02452528|O1|Outcome|ARC-520|"Intravenous administration of 1.0 mg/kg ARC-520 once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of study drug."
29296|NCT02452528|O2|Outcome|Placebo|"Intravenous administration of normal saline (0.9%) once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of placebo."
29297|NCT02452528|O1|Outcome|ARC-520|"Intravenous administration of 1.0 mg/kg ARC-520 once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of study drug."
29298|NCT02452528|O2|Outcome|Placebo|"Intravenous administration of normal saline (0.9%) once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of placebo."
29299|NCT02452528|O1|Outcome|ARC-520|"Intravenous administration of 1.0 mg/kg ARC-520 once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of study drug."
29300|NCT02452528|E2|Reported Event|Placebo|"Intravenous administration of normal saline (0.9%) once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of placebo."
29301|NCT02452528|E1|Reported Event|ARC-520|"Intravenous administration of 1.0 mg/kg ARC-520 once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.~Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of study drug."
29302|NCT02452320|B3|Baseline|Total|Total of all reporting groups
29303|NCT02452320|B2|Baseline|Acetaminophen IV|"Subjects randomized into the active treatment group will receive intravenous acetaminophen~intravenous acetaminophen: administration of 1000mg of intravenous acetaminophen or placebo every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia"
29304|NCT02452320|B1|Baseline|Placebo|"Subjects randomized into the control group will not receive study medication, they will receive a placebo administered at the same schedule as the active drug in the other arm.~Placebo: Subjects randomized to placebo will receive every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia"
29305|NCT02452320|P2|Participant Flow|Acetaminophen IV|"Subjects randomized into the active treatment group will receive intravenous acetaminophen~intravenous acetaminophen: administration of 1000mg of intravenous acetaminophen or placebo every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia"
29306|NCT02452320|P1|Participant Flow|Placebo|"Subjects randomized into the control group will not receive study medication, they will receive a placebo administered at the same schedule as the active drug in the other arm.~Placebo: Subjects randomized to placebo will receive every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia"
29307|NCT02452320|O2|Outcome|Acetaminophen IV|"Subjects randomized into the active treatment group will receive intravenous acetaminophen~intravenous acetaminophen: administration of 1000mg of intravenous acetaminophen or placebo every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia"
29308|NCT02452320|O1|Outcome|Placebo|"Subjects randomized into the control group will not receive study medication, they will receive a placebo administered at the same schedule as the active drug in the other arm.~Placebo: Subjects randomized to placebo will receive every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia"
29309|NCT02452320|O2|Outcome|Acetaminophen IV|"Subjects randomized into the active treatment group will receive intravenous acetaminophen~intravenous acetaminophen: administration of 1000mg of intravenous acetaminophen or placebo every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia"
29310|NCT02452320|O1|Outcome|Placebo|"Subjects randomized into the control group will not receive study medication, they will receive a placebo administered at the same schedule as the active drug in the other arm.~Placebo: Subjects randomized to placebo will receive every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia"
29311|NCT02452320|O2|Outcome|Acetaminophen IV|"Subjects randomized into the active treatment group will receive intravenous acetaminophen~intravenous acetaminophen: administration of 1000mg of intravenous acetaminophen or placebo every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia"
29312|NCT02452320|O1|Outcome|Placebo|"Subjects randomized into the control group will not receive study medication, they will receive a placebo administered at the same schedule as the active drug in the other arm.~Placebo: Subjects randomized to placebo will receive every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia"
29313|NCT02452320|E2|Reported Event|Acetaminophen IV|"Subjects randomized into the active treatment group will receive intravenous acetaminophen~intravenous acetaminophen: administration of 1000mg of intravenous acetaminophen or placebo every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia"
29314|NCT02452320|E1|Reported Event|Placebo|"Subjects randomized into the control group will not receive study medication, they will receive a placebo administered at the same schedule as the active drug in the other arm.~Placebo: Subjects randomized to placebo will receive every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia"
29315|NCT02451917|B3|Baseline|Total|Total of all reporting groups
29416|NCT02451150|E2|Reported Event|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
29316|NCT02451917|B2|Baseline|NPH Insulin, Then Glargine Insulin|The same total daily NPH insulin dose was maintained for those randomized to INPH. All of them had pre-prandial Regular insulin (Humulin R™, Lilly, Brazil) switched to Lispro insulin (Humalog™, Lilly, Brazil), at the same dose as in use previously. . After 24 weeks, basal insulins were switched; in other words, individuals on NPH in the first period switched to glargine insulin, and the doses of pre-meal insulin were sustained.
29317|NCT02451917|B1|Baseline|Glargine Insulin, Then NPH Insulin|The initial insulin dose for those randomized to IGlar was 80% of the total daily NPH dose that was being discontinued. All of them had pre-prandial Regular insulin switched to Lispro insulin (Humalog™, Lilly, Brazil), at the same dose as in use previously. After 24 weeks, basal insulins were switched; in other words, individuals on IGlar in the first period switched to INPH, and the doses of pre-meal insulin were sustained
29318|NCT02451917|P2|Participant Flow|NPH Insulin, Then Glargine Insulin|The same total daily NPH insulin dose was maintained for those randomized to INPH. All of them had pre-prandial Regular insulin (Humulin R™, Lilly, Brazil) switched to Lispro insulin (Humalog™, Lilly, Brazil), at the same dose as in use previously. . After 24 weeks, basal insulins were switched; in other words, individuals on NPH in the first period switched to glargine insulin, and the doses of pre-meal insulin were sustained.
29319|NCT02451917|P1|Participant Flow|Glargine Insulin, Then NPH Insulin|The initial insulin dose for those randomized to IGlar was 80% of the total daily NPH dose that was being discontinued. All of them had pre-prandial Regular insulin switched to Lispro insulin (Humalog™, Lilly, Brazil), at the same dose as in use previously. After 24 weeks, basal insulins were switched; in other words, individuals on IGlar in the first period switched to INPH, and the doses of pre-meal insulin were sustained
29320|NCT02451917|O2|Outcome|NPH Insulin Period|This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of NPH insulin, regardless of the sequence were grouped as NPH insulin.
29321|NCT02451917|O1|Outcome|Glargine Insulin Period|This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of insulin glargine, regardless of the sequence were grouped as glargine insulin.
29322|NCT02451917|O2|Outcome|NPH Insulin Period|This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of NPH insulin, regardless of the sequence were grouped as NPH insulin.
29323|NCT02451917|O1|Outcome|Glargine Insulin Period|This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of insulin glargine, regardless of the sequence were grouped as glargine insulin.
29324|NCT02451917|O2|Outcome|NPH Insulin Period|This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of NPH insulin, regardless of the sequence were grouped as NPH insulin.
29325|NCT02451917|O1|Outcome|Glargine Insulin Period|This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of insulin glargine, regardless of the sequence were grouped as glargine insulin.
29326|NCT02451917|O2|Outcome|NPH Insulin|This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of NPH insulin, regardless of the sequence were grouped as NPH insulin.
29327|NCT02451917|O1|Outcome|Glargine Insulin|This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of insulin glargine, regardless of the sequence were grouped as glargine insulin.
29328|NCT02451917|O2|Outcome|NPH Insulin Period|This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of NPH insulin, regardless of the sequence were grouped as NPH insulin.
29329|NCT02451917|O1|Outcome|Glargine Insulin Period|This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of NPH insulin, regardless of the sequence were grouped as glargine insulin.
29330|NCT02451917|O2|Outcome|NPH Insulin Period|This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of NPH insulin, regardless of the sequence were grouped as NPH insulin.
29331|NCT02451917|O1|Outcome|Glargine Insulin Period|This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of insulin glargine, regardless of the sequence were grouped as glargine insulin.
29332|NCT02451917|O2|Outcome|NPH Insulin Period|This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of NPH insulin, regardless of the sequence were grouped as NPH insulin.
29333|NCT02451917|O1|Outcome|Glargine Insulin Period|This is an open-label, randomized, two-way crossover study, one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of insulin glargine, regardless of the sequence were grouped as glargine insulin.
29334|NCT02451917|E2|Reported Event|NPH Insulin|"This is an open-label, randomized, two-way crossover study , one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin.~At the end of the study, all data acquired during the use of NPH insulin, regardless of the sequence were grouped as NPH.~NPH insulin: The same total daily NPH insulin dose was maintained for those randomized to INPH. All of them had pre-prandial Regular insulin (Humulin R™, Lilly, Brazil) switched to Lispro insulin (Humalog™, Lilly, Brazil), at the same dose as in use previously. . After 24 weeks, basal insulins were switched; in other words, individuals on NPH in the first period switched to glargine insulin, and the doses of pre-meal insulin were sustained."
29335|NCT02451917|E1|Reported Event|Glargine Insulin|"This is an open-label, randomized, two-way crossover study , one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of insulin glargine, regardless of the sequence were grouped as glargine.~Glargine insulin: The initial insulin dose for those randomized to IGlar was 80% of the total daily NPH dose that was being discontinued. All of them had pre-prandial Regular insulin switched to Lispro insulin (Humalog™, Lilly, Brazil), at the same dose as in use previously. After 24 weeks, basal insulins were switched; in other words, individuals on IGlar in the first period switched to INPH, and the doses of pre-meal insulin were sustained"
29336|NCT02451358|B5|Baseline|Total|Total of all reporting groups
29337|NCT02451358|B4|Baseline|Quadrivalent Influenza Vaccine Group 4: >=18 Years|Participants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
29338|NCT02451358|B3|Baseline|Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years|Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.
29339|NCT02451358|B2|Baseline|Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years|Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.
29340|NCT02451358|B1|Baseline|Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months|Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.
29341|NCT02451358|P4|Participant Flow|Quadrivalent Influenza Vaccine Group 4: >=18 Years|Participants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
29342|NCT02451358|P3|Participant Flow|Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years|Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.
29343|NCT02451358|P2|Participant Flow|Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years|Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 Southern Hemisphere (SH) formulation) intramuscularly, 1 injection each at Day 0 and 28.
29344|NCT02451358|P1|Participant Flow|Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months|Participants aged 6 to 35 months received 2 doses of 0.25 mL Quadrivalent Influenza Vaccine (QIV) (2016-2017 Northern Hemisphere (NH) formulation) intramuscularly, 1 injection each at Day 0 and 28.
29345|NCT02451358|O4|Outcome|Quadrivalent Influenza Vaccine Group 4: >=18 Years|Participants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
29346|NCT02451358|O3|Outcome|Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years|Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.
29347|NCT02451358|O2|Outcome|Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years|Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.
29348|NCT02451358|O1|Outcome|Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months|Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.
29349|NCT02451358|O4|Outcome|Quadrivalent Influenza Vaccine Group 4: >=18 Years|Participants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
29350|NCT02451358|O3|Outcome|Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years|Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.
29351|NCT02451358|O2|Outcome|Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years|Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.
29352|NCT02451358|O1|Outcome|Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months|Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.
29353|NCT02451358|O4|Outcome|Quadrivalent Influenza Vaccine Group 4: >=18 Years|Participants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
29354|NCT02451358|O3|Outcome|Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years|Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.
29355|NCT02451358|O2|Outcome|Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years|Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.
29356|NCT02451358|O1|Outcome|Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months|Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.
29357|NCT02451358|O4|Outcome|Quadrivalent Influenza Vaccine Group 4: >=18 Years|Participants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
29358|NCT02451358|O3|Outcome|Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years|Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.
29359|NCT02451358|O2|Outcome|Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years|Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.
29360|NCT02451358|O1|Outcome|Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months|Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.
29361|NCT02451358|E4|Reported Event|Quadrivalent Influenza Vaccine Group 4: >=18 Years|Participants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
29362|NCT02451358|E3|Reported Event|Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years|Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.
29364|NCT02451358|E1|Reported Event|Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months|Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.
29365|NCT02451150|B3|Baseline|Total|Total of all reporting groups
29366|NCT02451150|B2|Baseline|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
29367|NCT02451150|B1|Baseline|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
29368|NCT02451150|P2|Participant Flow|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
29369|NCT02451150|P1|Participant Flow|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
29370|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
29371|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
29372|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
29373|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
29374|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
29375|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
29376|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
29377|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
29378|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
29379|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
29380|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
29381|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
29382|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
29383|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
29384|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
29385|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
29386|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
29387|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
29388|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
29389|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
29390|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
29391|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
29392|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
29393|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
29394|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
29395|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
29396|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
29397|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
29398|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
29399|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
29400|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
29401|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
29402|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
29403|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
29404|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
29405|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
29406|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
29407|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
29408|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
29409|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
29410|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
29411|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
29412|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
29413|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
29414|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
29551|NCT02449018|P2|Participant Flow|Placebo|Placebo (70 days, run-in, treatment and wash-out periods)
29419|NCT02450799|B3|Baseline|PMMA|Polymethylmethacrylate IOL, prior implantation (1994-2000) in one or both eyes
29420|NCT02450799|B2|Baseline|Silicone|Silicone IOL, prior implantation (1994-2000) in one or both eyes
29421|NCT02450799|B1|Baseline|AcrySof|Acrylic IOL, prior implantation (1994-2000) in one or both eyes
29422|NCT02450799|P3|Participant Flow|PMMA|Polymethylmethacrylate (PMMA) IOL, prior implantation (1994-2000) in one or both eyes
29423|NCT02450799|P2|Participant Flow|Silicone|Silicone IOL, prior implantation (1994-2000) in one or both eyes
29424|NCT02450799|P1|Participant Flow|AcrySof|Acrylic IOL, prior implantation (1994-2000) in one or both eyes
29425|NCT02450799|O3|Outcome|PMMA|Polymethylmethacrylate IOL, prior implantation (1994-2000) in one or both eyes
29426|NCT02450799|O2|Outcome|Silicone|Silicone IOL, prior implantation (1994-2000) in one or both eyes
29427|NCT02450799|O1|Outcome|AcrySof|Acrylic IOL, prior implantation (1994-2000) in one or both eyes
29428|NCT02450799|E6|Reported Event|PMMA (Prospective)|Subjects with prior implantation of PMMA IOL who experienced an AE with onset after the Informed Consent acquisition
29429|NCT02450799|E5|Reported Event|Silicone (Prospective)|Subjects with prior implantation of Silicone IOL who experienced an AE with onset after the Informed Consent acquisition
29430|NCT02450799|E4|Reported Event|AcrySof (Prospective)|Subjects with prior implantation of acrylic IOL who experienced an AE with onset after the Informed Consent acquisition
29431|NCT02450799|E3|Reported Event|PMMA (Retrospective)|Subjects with prior implantation of PMMA IOL who experienced an AE related to decrease of BCVA in the study eye
29432|NCT02450799|E2|Reported Event|Silicone (Retrospective)|Subjects with prior implantation of Silicone IOL who experienced an AE related to decrease of BCVA in the study eye
29433|NCT02450799|E1|Reported Event|AcrySof (Retrospective)|Subjects with prior implantation of acrylic IOL who experienced an AE related to decrease of BCVA in the study eye
29434|NCT02450747|B1|Baseline|Multi-focal(Etafilcon A)|All subjects wore the Test Contact Lens, Multi-focal (etafilcon A) as a daily wear modality over a period of four weeks.
29435|NCT02450747|P1|Participant Flow|Multi-focal(Etafilcon A)|All subjects worn the Test Contact Lens, Multi-focal (etafilcon A) as daily wear modality over a period of four weeks.
29436|NCT02450747|O2|Outcome|Multi-focal(Etafilcon A)|All subjects wore the study lens, Multi-focal (etafilcon A) as a daily wear modality over a period of four weeks.
29437|NCT02450747|O1|Outcome|Baseline|Measurements taken at baseline are on all subjects that had already been dispensed the study lens. Only baseline measurements from subject included in the analysis population was reported.
29438|NCT02450747|O2|Outcome|Multi-focal(Etafilcon A)|All subjects wore the study Lens, Multi-focal (etafilcon A) as a daily wear modality over a period of four weeks.
29439|NCT02450747|O1|Outcome|Basline|Measurements taken at baseline are on all subjects that had already been dispensed the study lens. Only baseline measurements from subject included in the analysis population was reported.
29440|NCT02450747|O2|Outcome|Multi-focal(Etafilcon A)|All subjects wore the study lens, Multi-focal (etafilcon A ) as daily wear modality over a period of four weeks.
29441|NCT02450747|O1|Outcome|Baseline|Measurements taken at baseline are on all subjects that had already been dispensed the study lens. Only baseline measurements from subject included in the analysis population was reported.
29442|NCT02450747|E1|Reported Event|Multi-focal(Etafilcon A)|All subjects worn the Test Contact Lens, Multi-focal (etafilcon A) as daily wear modality over a period of four weeks.
29443|NCT02450591|B1|Baseline|Oligometastatic Non-Small Cell Lung Cancer|Patients will be placed on EGFR-TKI for their metastatic EGFR-mutant stage IV oligometastatic disease. All patients will undergo induction TKI for 12 weeks. At the conclusion of 12 weeks on erlotinib, patients without disease progression [partial response (PR) or stable disease (SD)] will undergo definitive local treatment to all remaining sites of disease. After local therapy, erlotinib will be resumed until progression of disease (POD) by RECIST criteria. All assessments completed during the 12 week TKI induction phase are to be performed per protocol with a ± 7 day window.
29444|NCT02450591|P1|Participant Flow|Oligometastatic Non-Small Cell Lung Cancer|Patients will be placed on EGFR-TKI for their metastatic EGFR-mutant stage IV oligometastatic disease. All patients will undergo induction TKI for 12 weeks. At the conclusion of 12 weeks on erlotinib, patients without disease progression [partial response (PR) or stable disease (SD)] will undergo definitive local treatment to all remaining sites of disease. After local therapy, erlotinib will be resumed until progression of disease (POD) by RECIST criteria. All assessments completed during the 12 week TKI induction phase are to be performed per protocol with a ± 7 day window.
29445|NCT02450591|O1|Outcome|Oligometastatic Non-Small Cell Lung Cancer|Patients will be placed on EGFR-TKI for their metastatic EGFR-mutant stage IV oligometastatic disease. All patients will undergo induction TKI for 12 weeks. At the conclusion of 12 weeks on erlotinib, patients without disease progression [partial response (PR) or stable disease (SD)] will undergo definitive local treatment to all remaining sites of disease. After local therapy, erlotinib will be resumed until progression of disease (POD) by RECIST criteria. All assessments completed during the 12 week TKI induction phase are to be performed per protocol with a ± 7 day window.
29446|NCT02450591|E1|Reported Event|Oligometastatic Non-Small Cell Lung Cancer|Patients will be placed on EGFR-TKI for their metastatic EGFR-mutant stage IV oligometastatic disease. All patients will undergo induction TKI for 12 weeks. At the conclusion of 12 weeks on erlotinib, patients without disease progression [partial response (PR) or stable disease (SD)] will undergo definitive local treatment to all remaining sites of disease. After local therapy, erlotinib will be resumed until progression of disease (POD) by RECIST criteria. All assessments completed during the 12 week TKI induction phase are to be performed per protocol with a ± 7 day window.
29447|NCT02450383|B3|Baseline|Total|Total of all reporting groups
29448|NCT02450383|B2|Baseline|Experimental|"Implant placement with simultaneous acellular dermal matrix graft (human allograft)~Alloderm®"
29449|NCT02450383|B1|Baseline|Control|"Implant placement with subepithelial connective tissue graft~Autologous subepithelial connective tissue graft"
29450|NCT02450383|P2|Participant Flow|Experimental|"Implant placement with simultaneous acellular dermal matrix graft (human allograft)~Alloderm®"
29451|NCT02450383|P1|Participant Flow|Control|"Implant placement with subepithelial connective tissue graft~Autologous subepithelial connective tissue graft"
31283|NCT02434939|B3|Baseline|Total|Total of all reporting groups
29452|NCT02450383|O2|Outcome|Experimental|"Implant placement with simultaneous acellular dermal matrix graft (human allograft)~Alloderm®"
29453|NCT02450383|O1|Outcome|Control|"Implant placement with subepithelial connective tissue graft~Autologous subepithelial connective tissue graft"
29454|NCT02450383|O2|Outcome|Experimental|"Implant placement with simultaneous acellular dermal matrix graft (human allograft)~Alloderm®"
29455|NCT02450383|O1|Outcome|Control|"Implant placement with subepithelial connective tissue graft~Autologous subepithelial connective tissue graft"
29456|NCT02450383|O2|Outcome|Experimental|"Implant placement with simultaneous acellular dermal matrix graft (human allograft)~Alloderm®"
29457|NCT02450383|O1|Outcome|Control|"Implant placement with subepithelial connective tissue graft~Autologous subepithelial connective tissue graft"
29458|NCT02450383|O2|Outcome|Experimental|"Implant placement with simultaneous acellular dermal matrix graft (human allograft)~Alloderm®"
29459|NCT02450383|O1|Outcome|Control|"Implant placement with subepithelial connective tissue graft~Autologous subepithelial connective tissue graft"
29460|NCT02450383|E2|Reported Event|Experimental|"Implant placement with simultaneous acellular dermal matrix graft (human allograft)~Alloderm®"
29461|NCT02450383|E1|Reported Event|Control|"Implant placement with subepithelial connective tissue graft~Autologous subepithelial connective tissue graft"
29462|NCT02449915|B3|Baseline|Total|Total of all reporting groups
29463|NCT02449915|B2|Baseline|Placebo Arm|Receiving 30 mL sterile normal saline at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
29464|NCT02449915|B1|Baseline|Bupivacaine Arm|Receiving 30mL dilutional volume of the liposomal bupivacaine at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
29465|NCT02449915|P2|Participant Flow|Placebo Arm|Receiving 30 mL volume of sterile normal saline at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
29466|NCT02449915|P1|Participant Flow|Bupivacaine Arm|Receiving 30mL dilutional volume of liposomal bupivacaine at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
29467|NCT02449915|O2|Outcome|Placebo Arm|Receiving 30 mL volume of sterile normal saline at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
29468|NCT02449915|O1|Outcome|Bupivacaine Arm|Receiving 30mL dilutional volume of liposomal bupivacaine at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
29469|NCT02449915|E2|Reported Event|Placebo Arm|Receiving 30 mL volume of sterile normal saline at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
29470|NCT02449915|E1|Reported Event|Bupivacaine Arm|Receiving 30mL dilutional volume of liposomal bupivacaine at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
29471|NCT02449902|B3|Baseline|Total|Total of all reporting groups
29472|NCT02449902|B2|Baseline|Placebo Daily for 14 Days|Control treatment group. Subjects self-administered the control treatment, a single placebo matching capsule, intravaginally once daily for 14 days.
29473|NCT02449902|B1|Baseline|Estradiol 10 μg Daily for 14 Days|Active treatment group. Subjects self-administered the active treatment, a single capsule of 10 μg Estradiol, intravaginally once daily for 14 days.
29474|NCT02449902|P2|Participant Flow|Placebo|Control treatment group. Subjects self-administered the control treatment, a single placebo matching capsule, intravaginally once daily for 14 days.
29475|NCT02449902|P1|Participant Flow|TX-12-004-HR 10μg|Active treatment group. Subjects self-administered the active treatment, a single capsule of 10 μg Estradiol, intravaginally once daily for 14 days.
29476|NCT02449902|O2|Outcome|Placebo|Control treatment group.
29477|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
29478|NCT02449902|O2|Outcome|Treatment 2|"Placebo vaginal softgel capsule~placebo: 1 placebo capsule inserted vaginally for 14 days."
29479|NCT02449902|O1|Outcome|Treatment 1|"Estradiol 10 μg vaginal softgel capsule~Estradiol: 1 10 µg capsule inserted vaginally for 14 days."
29480|NCT02449902|O2|Outcome|Placebo|Control treatment group.
29481|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
29482|NCT02449902|O2|Outcome|Placebo|Control treatment group.
29483|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
29484|NCT02449902|O2|Outcome|Placebo|Control treatment group.
29485|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
29486|NCT02449902|O2|Outcome|Placebo|Control treatment group.
29487|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
29488|NCT02449902|O2|Outcome|Placebo|Control treatment group.
29489|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
29490|NCT02449902|O2|Outcome|Placebo|Control treatment group.
29491|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
29492|NCT02449902|O2|Outcome|Placebo|Control treatment group.
29493|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
29494|NCT02449902|O2|Outcome|Placebo|Control treatment group.
29495|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
29496|NCT02449902|E2|Reported Event|Placebo|Control treatment group.
29497|NCT02449902|E1|Reported Event|TX-12-004-HR|Active treatment group.
29498|NCT02449798|B1|Baseline|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
29552|NCT02449018|P1|Participant Flow|QBW251|QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)
29553|NCT02449018|O2|Outcome|Placebo|Placebo (70 days, run-in, treatment and wash-out periods)
29499|NCT02449798|P1|Participant Flow|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 Blood Control (BC) peripheral intravenous (PIV) device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
29500|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
29501|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
29502|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
29503|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
29504|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
29505|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
29506|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
29507|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
29508|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
29509|NCT02449798|E1|Reported Event|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
29510|NCT02449356|B3|Baseline|Total|Total of all reporting groups
29511|NCT02449356|B2|Baseline|Traditional Endotracheal Tube(TT)|We enrolled total 60 adult patients undergoing prone position ventilation surgery,and randomized to each group.30 subjects were involved in the traditional endotracheal tube group(TT), in which group the patients were intubated with the routine endotracheal tube.
29512|NCT02449356|B1|Baseline|Prone Position Endotracheal Tube(PPT)|We enrolled total 60 adult patients undergoing prone position ventilation surgery,and randomized to each group.30 subjects were involved in the prone position endotracheal tube group(PPT), in which group the patients were intubated with the custom-designed endotracheal tube.
29513|NCT02449356|P2|Participant Flow|Prone Position Endotracheal Tube(PPT)|"the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.~prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes"
29514|NCT02449356|P1|Participant Flow|Traditional Endotracheal Tube(TT)|the subjects of this arm are given the routine endotracheal tube.
29515|NCT02449356|O2|Outcome|Prone Ventilation Endotracheal Tube|"the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.~prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes"
29516|NCT02449356|O1|Outcome|the Traditional Endotracheal Tube|the subjects of this arm are given the routine endotracheal tube.
29517|NCT02449356|O2|Outcome|Prone Ventilation Endotracheal Tube|"the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.~prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes"
29518|NCT02449356|O1|Outcome|the Traditional Endotracheal Tube|the subjects of this arm are given the routine endotracheal tube.
29519|NCT02449356|O2|Outcome|Prone Ventilation Endotracheal Tube|"the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.~prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes"
29520|NCT02449356|O1|Outcome|the Traditional Endotracheal Tube|the subjects of this arm are given the routine endotracheal tube.
29521|NCT02449356|O2|Outcome|Prone Ventilation Endotracheal Tube|"the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.~prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes"
29522|NCT02449356|O1|Outcome|the Traditional Endotracheal Tube|the subjects of this arm are given the routine endotracheal tube.
29523|NCT02449356|O2|Outcome|the Traditional Endotracheal Tube|the subjects of this arm are given the routine endotracheal tube.
29524|NCT02449356|O1|Outcome|Prone Ventilation Endotracheal Tube|"the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.~prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes"
29525|NCT02449356|O2|Outcome|the Traditional Endotracheal Tube|the subjects of this arm are given the routine endotracheal tube.
29526|NCT02449356|O1|Outcome|Prone Ventilation Endotracheal Tube|"the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.~prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes"
29527|NCT02449356|E2|Reported Event|Traditional Endotracheal Tube|there was one patient in this group occuring mild sore throat,and none occured dysphagia, dysphonia.
29528|NCT02449356|E1|Reported Event|Prone Position Endotracheal Tube|there was one patient in this group occuring mild sore throat,and none occured dysphagia, dysphonia.
29529|NCT02449044|B1|Baseline|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
29530|NCT02449044|P1|Participant Flow|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
29531|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
29532|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
29533|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
29534|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
29535|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
29536|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
29537|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
29538|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
29539|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
29540|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
29541|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
29542|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
29543|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
29544|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
29545|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
29546|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
29547|NCT02449044|E1|Reported Event|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
29548|NCT02449018|B3|Baseline|Total|Total of all reporting groups
29549|NCT02449018|B2|Baseline|Placebo|Placebo (70 days, run-in, treatment and wash-out periods)
29550|NCT02449018|B1|Baseline|QBW251|QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)
29554|NCT02449018|O1|Outcome|QBW251|QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)
29555|NCT02449018|O1|Outcome|QBW251|QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)
29556|NCT02449018|O1|Outcome|QBW251|QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)
29557|NCT02449018|O1|Outcome|QBW251|QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)
29558|NCT02449018|O2|Outcome|Placebo|Placebo (70 days, run-in, treatment and wash-out periods)
29559|NCT02449018|O1|Outcome|QBW251|QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)
29560|NCT02449018|O2|Outcome|Placebo|Placebo (70 days, run-in, treatment and wash-out periods)
29561|NCT02449018|O1|Outcome|QBW251|QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)
29562|NCT02449018|O2|Outcome|Placebo|Placebo (70 days, run-in, treatment and wash-out periods)
29563|NCT02449018|O1|Outcome|QBW251|QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)
29564|NCT02449018|O2|Outcome|Placebo|Placebo (70 days, run-in, treatment and wash-out periods)
29565|NCT02449018|O1|Outcome|QBW251|QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)
29566|NCT02449018|O2|Outcome|Placebo|Placebo (70 days, run-in, treatment and wash-out periods)
29567|NCT02449018|O1|Outcome|QBW251|QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)
29568|NCT02449018|O2|Outcome|Placebo|Placebo (70 days, run-in, treatment and wash-out periods)
29569|NCT02449018|O1|Outcome|QBW251|QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)
29570|NCT02449018|O2|Outcome|Placebo|Placebo (70 days, run-in, treatment and wash-out periods)
29571|NCT02449018|O1|Outcome|QBW251|QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)
29572|NCT02449018|O2|Outcome|Placebo|Placebo (70 days, run-in, treatment and wash-out periods)
29573|NCT02449018|O1|Outcome|QBW251|QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)
29574|NCT02449018|O2|Outcome|Placebo|Placebo (70 days, run-in, treatment and wash-out periods)
29575|NCT02449018|O1|Outcome|QBW251|QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)
29576|NCT02449018|E2|Reported Event|QBW251 300 mg Bid|QBW251 (28 day treatment period) and placebo (42 days, run-in and wash-out periods)
29577|NCT02449018|E1|Reported Event|Placebo|Placebo (70 days, run-in, treatment and wash-out periods)
29578|NCT02448914|B1|Baseline|TRIGEL and Duodopa in Randomized Order|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone). Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made. All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
29579|NCT02448914|P2|Participant Flow|Duodopa First, Then TRIGEL|"First Intervention (Day 1): Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~Second Intervention (Day 2): TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made. All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
29580|NCT02448914|P1|Participant Flow|TRIGEL First, Then Duodopa|"First Intervention (Day 1): TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~Second Intervention (Day 2): Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made. All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
29581|NCT02448914|O2|Outcome|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
29582|NCT02448914|O1|Outcome|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study.~Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
29719|NCT02448537|B2|Baseline|PM01183 and Gemcitabine|"Prior anthracycline exposure and without prior gemcitabine exposure~PM01183 predetermined dose given twice via IV per cycle~Gemcitabine predetermined dose given twice via IV per cycle~PM01183~Gemcitabine"
29583|NCT02448914|O2|Outcome|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
29584|NCT02448914|O1|Outcome|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
29585|NCT02448914|O2|Outcome|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
29586|NCT02448914|O1|Outcome|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study.~Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
29587|NCT02448914|O2|Outcome|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
29588|NCT02448914|O1|Outcome|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
29589|NCT02448914|O2|Outcome|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
29590|NCT02448914|O1|Outcome|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
29591|NCT02448914|O2|Outcome|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
29592|NCT02448914|O1|Outcome|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study.~Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
29593|NCT02448914|E2|Reported Event|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
29618|NCT02448810|B3|Baseline|Part 1: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29594|NCT02448914|E1|Reported Event|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
29595|NCT02448862|B3|Baseline|Total|Total of all reporting groups
29596|NCT02448862|B2|Baseline|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
29597|NCT02448862|B1|Baseline|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
29598|NCT02448862|P2|Participant Flow|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
29599|NCT02448862|P1|Participant Flow|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
29600|NCT02448862|O2|Outcome|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
29601|NCT02448862|O1|Outcome|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
29602|NCT02448862|O2|Outcome|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
29603|NCT02448862|O1|Outcome|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
29604|NCT02448862|O2|Outcome|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
39940|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
29605|NCT02448862|O1|Outcome|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
29606|NCT02448862|O2|Outcome|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
29607|NCT02448862|O1|Outcome|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
29608|NCT02448862|O2|Outcome|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
29609|NCT02448862|O1|Outcome|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
29610|NCT02448862|E2|Reported Event|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
29611|NCT02448862|E1|Reported Event|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
29612|NCT02448810|B9|Baseline|Total|Total of all reporting groups
29613|NCT02448810|B8|Baseline|Part 2: Standard of Care Wild Type|Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29614|NCT02448810|B7|Baseline|Part 2: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29615|NCT02448810|B6|Baseline|Part 2: Standard of Care Mutant|Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29616|NCT02448810|B5|Baseline|Part 2: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29617|NCT02448810|B4|Baseline|Part 1: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29718|NCT02448537|B3|Baseline|Single Agent PM01183|"Patients who have received at least both prior anthracycline and prior gemcitabine~-PM01183 predetermined dose once via IV per cycle~PM01183"
29619|NCT02448810|B2|Baseline|Part 1: Imalumab 7.5 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29620|NCT02448810|B1|Baseline|Part 1: Imalumab 7.5 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29621|NCT02448810|P8|Participant Flow|Part 2: Standard of Care Wild Type|Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29622|NCT02448810|P7|Participant Flow|Part 2: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29623|NCT02448810|P6|Participant Flow|Part 2: Standard of Care Mutant|Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29624|NCT02448810|P5|Participant Flow|Part 2: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29625|NCT02448810|P4|Participant Flow|Part 1: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29626|NCT02448810|P3|Participant Flow|Part 1: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29627|NCT02448810|P2|Participant Flow|Part 1: Imalumab 7.5 mg/kg + Panitumumab|Participants with wild-type tumors (wild type Kirsten rat sarcoma viral oncogene homolog, wild neuroblastoma rat sarcoma viral oncogene homolog [KRAS wt, NRAS wt]) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29628|NCT02448810|P1|Participant Flow|Part 1: Imalumab 7.5 mg/kg + 5-FU/LV|Participants with mutated tumors (mutated kirsten rat sarcoma viral oncogene homolog, mutated neuroblastoma rat sarcoma viral oncogene homolog [KRAS mut, NRAS mut]) received 7.5 milligram per kilogram (mg/kg) dose of imalumab every week (QW) in combination with 5-fluorouracil/leucovorin ([FU/LV] LV 400 milligram per square meter [mg/m^2] intravenous (IV) infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) for every 2 weeks (Q2W) IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29629|NCT02448810|O8|Outcome|Part 2: Standard of Care Wild Type|Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29630|NCT02448810|O7|Outcome|Part 2: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29631|NCT02448810|O6|Outcome|Part 2: Standard of Care Mutant|Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29632|NCT02448810|O5|Outcome|Part 2: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29633|NCT02448810|O4|Outcome|Part 1: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29634|NCT02448810|O3|Outcome|Part 1: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29913|NCT02447029|E2|Reported Event|Standard Lidocaine Paracervical Block|"standard lidocaine paracervical block~standard lidocaine paracervical block: 1% lidocaine paracervical injection"
29635|NCT02448810|O2|Outcome|Part 1: Imalumab 7.5 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29636|NCT02448810|O1|Outcome|Part 1: Imalumab 7.5 mg/kg + 5-Fluorouracil/Leucovorin (FU/LV)|Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29637|NCT02448810|O8|Outcome|Part 2: Standard of Care Wild Type|Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29638|NCT02448810|O7|Outcome|Part 2: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29639|NCT02448810|O6|Outcome|Part 2: Standard of Care Mutant|Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29640|NCT02448810|O5|Outcome|Part 2: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29641|NCT02448810|O4|Outcome|Part 1: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29642|NCT02448810|O3|Outcome|Part 1: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29643|NCT02448810|O2|Outcome|Part 1: Imalumab 7.5 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29644|NCT02448810|O1|Outcome|Part 1: Imalumab 7.5 mg/kg + 5-Fluorouracil/Leucovorin (FU/LV)|Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29645|NCT02448810|O8|Outcome|Part 2: Standard of Care Wild Type|Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29646|NCT02448810|O7|Outcome|Part 2: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29647|NCT02448810|O6|Outcome|Part 2: Standard of Care Mutant|Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29648|NCT02448810|O5|Outcome|Part 2: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29649|NCT02448810|O4|Outcome|Part 1: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29650|NCT02448810|O3|Outcome|Part 1: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29651|NCT02448810|O2|Outcome|Part 1: Imalumab 7.5 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
30220|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
29652|NCT02448810|O1|Outcome|Part 1: Imalumab 7.5 mg/kg + 5-Fluorouracil/Leucovorin (FU/LV)|Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29653|NCT02448810|O8|Outcome|Part 2: Standard of Care Wild Type|Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29654|NCT02448810|O7|Outcome|Part 2: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29655|NCT02448810|O6|Outcome|Part 2: Standard of Care Mutant|Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29656|NCT02448810|O5|Outcome|Part 2: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29657|NCT02448810|O4|Outcome|Part 1: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29658|NCT02448810|O3|Outcome|Part 1: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29659|NCT02448810|O2|Outcome|Part 1: Imalumab 7.5 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29660|NCT02448810|O1|Outcome|Part 1: Imalumab 7.5 mg/kg + 5-Fluorouracil/Leucovorin (FU/LV)|Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29661|NCT02448810|O8|Outcome|Part 2: Standard of Care Wild Type|Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29662|NCT02448810|O7|Outcome|Part 2: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29663|NCT02448810|O6|Outcome|Part 2: Standard of Care Mutant|Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29664|NCT02448810|O5|Outcome|Part 2: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29665|NCT02448810|O4|Outcome|Part 1: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29666|NCT02448810|O3|Outcome|Part 1: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29667|NCT02448810|O2|Outcome|Part 1: Imalumab 7.5 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29668|NCT02448810|O1|Outcome|Part 1: Imalumab 7.5 mg/kg + 5-Fluorouracil/Leucovorin (FU/LV)|Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
39941|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
29669|NCT02448810|O8|Outcome|Part 2: Standard of Care Wild Type|Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29670|NCT02448810|O7|Outcome|Part 2: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29671|NCT02448810|O6|Outcome|Part 2: Standard of Care Mutant|Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29672|NCT02448810|O5|Outcome|Part 2: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29673|NCT02448810|O4|Outcome|Part 1: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29674|NCT02448810|O3|Outcome|Part 1: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29675|NCT02448810|O2|Outcome|Part 1: Imalumab 7.5 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29676|NCT02448810|O1|Outcome|Part 1: Imalumab 7.5 mg/kg + 5-Fluorouracil/Leucovorin (FU/LV)|Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29677|NCT02448810|O4|Outcome|Part 1: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29678|NCT02448810|O3|Outcome|Part 1: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29679|NCT02448810|O2|Outcome|Part 1: Imalumab 7.5 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29680|NCT02448810|O1|Outcome|Part 1: Imalumab 7.5 mg/kg + 5-Fluorouracil/Leucovorin (FU/LV)|Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29681|NCT02448810|O4|Outcome|Part 2: Standard of Care Wild Type|Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29682|NCT02448810|O3|Outcome|Part 2: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29683|NCT02448810|O2|Outcome|Part 2: Standard of Care Mutant|Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29684|NCT02448810|O1|Outcome|Part 2: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29685|NCT02448810|E8|Reported Event|Part 2: Standard of Care Wild Type|Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
30221|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
29686|NCT02448810|E7|Reported Event|Part 2: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29687|NCT02448810|E6|Reported Event|Part 2: Standard of Care Mutant|Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29688|NCT02448810|E5|Reported Event|Part 2: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29689|NCT02448810|E4|Reported Event|Part 1: Imalumab 10 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29690|NCT02448810|E3|Reported Event|Part 1: Imalumab 10 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29691|NCT02448810|E2|Reported Event|Part 1: Imalumab 7.5 mg/kg + Panitumumab|Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29692|NCT02448810|E1|Reported Event|Part 1: Imalumab 7.5 mg/kg + 5-FU/LV|Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
29693|NCT02448563|B5|Baseline|Total|Total of all reporting groups
29694|NCT02448563|B4|Baseline|Control Non-completers|"Non-completers~Standard of care - one counseling visit with a study dietitian"
29695|NCT02448563|B3|Baseline|Control Completers|Standard of care - one counseling visit with a study dietitian
29696|NCT02448563|B2|Baseline|Intervention Non-completers|"Non-completers~Weekly, in-person, support groups providing nutrition and physical activity education~Nutrition and physical activity education: Eight weekly in-person groups"
29697|NCT02448563|B1|Baseline|Intervention Completers|"Weekly, in-person, support groups providing nutrition and physical activity education~Nutrition and physical activity education: Eight weekly in-person groups"
29698|NCT02448563|P2|Participant Flow|Control|Standard of care - one counseling visit with a study dietitian
29699|NCT02448563|P1|Participant Flow|Intervention|"Weekly, in-person, support groups providing nutrition and physical activity education~Nutrition and physical activity education: Eight weekly in-person groups"
29700|NCT02448563|O4|Outcome|Control Non-completers|"Non-completers~Standard of care - one counseling visit with a study dietitian"
29701|NCT02448563|O3|Outcome|Control Completers|Standard of care - one counseling visit with a study dietitian
29702|NCT02448563|O2|Outcome|Intervention Non-completers|"Non-completers~Weekly, in-person, support groups providing nutrition and physical activity education~Nutrition and physical activity education: Eight weekly in-person groups"
29703|NCT02448563|O1|Outcome|Intervention Completers|"Weekly, in-person, support groups providing nutrition and physical activity education~Nutrition and physical activity education: Eight weekly in-person groups"
29704|NCT02448563|O2|Outcome|Control|Standard of care - one counseling visit with a study dietitian
29705|NCT02448563|O1|Outcome|Intervention|"Weekly, in-person, support groups providing nutrition and physical activity education~Nutrition and physical activity education: Eight weekly in-person groups"
29706|NCT02448563|O2|Outcome|Control|Standard of care - one counseling visit with a study dietitian
29707|NCT02448563|O1|Outcome|Intervention|"Weekly, in-person, support groups providing nutrition and physical activity education~Nutrition and physical activity education: Eight weekly in-person groups"
29708|NCT02448563|O2|Outcome|Control|Standard of care - one counseling visit with a study dietitian
29709|NCT02448563|O1|Outcome|Intervention|"Weekly, in-person, support groups providing nutrition and physical activity education~Nutrition and physical activity education: Eight weekly in-person groups"
29710|NCT02448563|O2|Outcome|Control|Standard of care - one counseling visit with a study dietitian
29711|NCT02448563|O1|Outcome|Intervention|"Weekly, in-person, support groups providing nutrition and physical activity education~Nutrition and physical activity education: Eight weekly in-person groups"
29712|NCT02448563|O2|Outcome|Control|Standard of care - one counseling visit with a study dietitian
29713|NCT02448563|O1|Outcome|Intervention|"Weekly, in-person, support groups providing nutrition and physical activity education~Nutrition and physical activity education: Eight weekly in-person groups"
29714|NCT02448563|O1|Outcome|Intervention|"Weekly, in-person, support groups providing nutrition and physical activity education~Nutrition and physical activity education: Eight weekly in-person groups"
29715|NCT02448563|E2|Reported Event|Control|Standard of care - one counseling visit with a study dietitian
29716|NCT02448563|E1|Reported Event|Intervention|"Weekly, in-person, support groups providing nutrition and physical activity education~Nutrition and physical activity education: Eight weekly in-person groups"
29717|NCT02448537|B4|Baseline|Total|Total of all reporting groups
30222|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
29720|NCT02448537|B1|Baseline|PM01183 and Doxorubicin|"Anthracycline-naïve patients will receive combination of PM01183 and Doxorubicin per cycle.~PM01183 predetermined dose daily via IV per cycle~Doxorubicin predetermined dose daily via IV per cycle~PM01183~Doxorubicin"
29721|NCT02448537|P3|Participant Flow|Single Agent PM01183|"Patients who have received at least both prior anthracycline and prior gemcitabine~-PM01183 predetermined dose once via IV per cycle~PM01183"
29722|NCT02448537|P2|Participant Flow|PM01183 and Gemcitabine|"Prior anthracycline exposure and without prior gemcitabine exposure~PM01183 predetermined dose given twice via IV per cycle~Gemcitabine predetermined dose given twice via IV per cycle~PM01183~Gemcitabine"
29723|NCT02448537|P1|Participant Flow|PM01183 and Doxorubicin|"Anthracycline-naïve patients will receive combination of PM01183 and Doxorubicin per cycle.~PM01183 predetermined dose daily via IV per cycle~Doxorubicin predetermined dose daily via IV per cycle~PM01183~Doxorubicin"
29724|NCT02448537|O3|Outcome|Single Agent PM01183|"Patients who have received at least both prior anthracycline and prior gemcitabine~-PM01183 predetermined dose once via IV per cycle~PM01183"
29725|NCT02448537|O2|Outcome|PM01183 and Gemcitabine|"Prior anthracycline exposure and without prior gemcitabine exposure~PM01183 predetermined dose given twice via IV per cycle~Gemcitabine predetermined dose given twice via IV per cycle~PM01183~Gemcitabine"
29726|NCT02448537|O1|Outcome|PM01183 and Doxorubicin|"Anthracycline-naïve patients will receive combination of PM01183 and Doxorubicin per cycle.~PM01183 predetermined dose daily via IV per cycle~Doxorubicin predetermined dose daily via IV per cycle~PM01183~Doxorubicin"
29727|NCT02448537|O3|Outcome|Single Agent PM01183|"Patients who have received at least both prior anthracycline and prior gemcitabine~-PM01183 predetermined dose once via IV per cycle~PM01183"
29728|NCT02448537|O2|Outcome|PM01183 and Gemcitabine|"Prior anthracycline exposure and without prior gemcitabine exposure~PM01183 predetermined dose given twice via IV per cycle~Gemcitabine predetermined dose given twice via IV per cycle~PM01183~Gemcitabine"
29729|NCT02448537|O1|Outcome|PM01183 and Doxorubicin|"Anthracycline-naïve patients will receive combination of PM01183 and Doxorubicin per cycle.~PM01183 predetermined dose daily via IV per cycle~Doxorubicin predetermined dose daily via IV per cycle~PM01183~Doxorubicin"
29730|NCT02448537|O3|Outcome|Single Agent PM01183|"Patients who have received at least both prior anthracycline and prior gemcitabine~-PM01183 predetermined dose once via IV per cycle~PM01183"
29731|NCT02448537|O2|Outcome|PM01183 and Gemcitabine|"Prior anthracycline exposure and without prior gemcitabine exposure~PM01183 predetermined dose given twice via IV per cycle~Gemcitabine predetermined dose given twice via IV per cycle~PM01183~Gemcitabine"
29732|NCT02448537|O1|Outcome|PM01183 and Doxorubicin|"Anthracycline-naïve patients will receive combination of PM01183 and Doxorubicin per cycle.~PM01183 predetermined dose daily via IV per cycle~Doxorubicin predetermined dose daily via IV per cycle~PM01183~Doxorubicin"
29733|NCT02448537|E3|Reported Event|Stratum C|"Patients who have received at least both prior anthracycline and prior gemcitabine~-PM01183 predetermined dose once via IV per cycle~PM01183"
29734|NCT02448537|E2|Reported Event|Stratum B|"Prior anthracycline exposure and without prior gemcitabine exposure~PM01183 predetermined dose given twice via IV per cycle~Gemcitabine predetermined dose given twice via IV per cycle~PM01183~Gemcitabine"
29735|NCT02448537|E1|Reported Event|Stratum A|"Anthracycline-naïve patients will receive combination of PM01183 and Doxorubicin per cycle.~PM01183 predetermined dose daily via IV per cycle~Doxorubicin predetermined dose daily via IV per cycle~PM01183~Doxorubicin"
29736|NCT02447848|B1|Baseline|Sufentanil Sublingual Tablet 30 mcg|Patients may be administered one tablet every 60 minutes as needed during the study period
29737|NCT02447848|P1|Participant Flow|Sufentanil Sublingual Tablet 30 mcg|Patients may be administered one tablet every 60 minutes as needed during the study period
29738|NCT02447848|O1|Outcome|Sufentanil Sublingual Tablet 30 mcg|Patients may be administered one tablet every 60 minutes as needed during the study period
29739|NCT02447848|O1|Outcome|Sufentanil Sublingual Tablet 30 mcg|Patients may be administered one tablet every 60 minutes as needed during the study period
29740|NCT02447848|O1|Outcome|Sufentanil Sublingual Tablet 30 mcg|Patients may be administered one tablet every 60 minutes as needed during the study period
29741|NCT02447848|E1|Reported Event|Sufentanil Sublingual Tablet 30 mcg|Patients may be administered one tablet every 60 minutes as needed during the study period
29742|NCT02447458|B7|Baseline|Total|Total of all reporting groups
29743|NCT02447458|B6|Baseline|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
29744|NCT02447458|B5|Baseline|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
29745|NCT02447458|B4|Baseline|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
29746|NCT02447458|B3|Baseline|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29747|NCT02447458|B2|Baseline|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
29748|NCT02447458|B1|Baseline|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
29749|NCT02447458|P6|Participant Flow|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
29750|NCT02447458|P5|Participant Flow|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
29751|NCT02447458|P4|Participant Flow|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
29752|NCT02447458|P3|Participant Flow|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29753|NCT02447458|P2|Participant Flow|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
29754|NCT02447458|P1|Participant Flow|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
29755|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29756|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
29757|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
30223|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
29758|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29759|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
29760|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
29761|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29762|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
29763|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
29764|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29765|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
29766|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
29767|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29768|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
29769|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
29770|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29771|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
29772|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
29773|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29774|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
29775|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
29776|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29777|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
29778|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
29779|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29780|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
29781|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
29782|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29783|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
29784|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
29785|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29786|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
29787|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
29788|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29789|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
29790|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
29791|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29792|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
29793|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
29794|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29795|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
29796|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
29797|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29798|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
29799|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
29800|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29801|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
29802|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
29803|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29804|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
29805|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
39942|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
29806|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29807|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
29808|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
29809|NCT02447458|O8|Outcome|Placebo (Fed)|Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29810|NCT02447458|O7|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29811|NCT02447458|O6|Outcome|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
29812|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
29813|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
29814|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29815|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
29816|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
29817|NCT02447458|O8|Outcome|Placebo (Fed)|Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29818|NCT02447458|O7|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29819|NCT02447458|O6|Outcome|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
29820|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
29821|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
29822|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29823|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
29824|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
29825|NCT02447458|O8|Outcome|Placebo (Fed)|Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29826|NCT02447458|O7|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29827|NCT02447458|O6|Outcome|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
29828|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
29829|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
29830|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29831|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
29832|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
29833|NCT02447458|O8|Outcome|Placebo (Fed)|Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29834|NCT02447458|O7|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29835|NCT02447458|O6|Outcome|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
29836|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
29837|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
29838|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29839|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
29840|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
29841|NCT02447458|E8|Reported Event|Placebo (Fed)|Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29842|NCT02447458|E7|Reported Event|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29843|NCT02447458|E6|Reported Event|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
29844|NCT02447458|E5|Reported Event|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
29845|NCT02447458|E4|Reported Event|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
29846|NCT02447458|E3|Reported Event|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
29847|NCT02447458|E2|Reported Event|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
29848|NCT02447458|E1|Reported Event|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
29849|NCT02447432|B3|Baseline|Total|Total of all reporting groups
29850|NCT02447432|B2|Baseline|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of Synflorix™ vaccine at approximatively 9 months of age (Epoch 002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine : right thigh; DTPw-HBV/Hibvaccine : left thigh).
29851|NCT02447432|B1|Baseline|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch 002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine : right thigh; DTPw-HBV/Hibvaccine : left thigh).
29852|NCT02447432|P2|Participant Flow|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29853|NCT02447432|P1|Participant Flow|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29854|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29855|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29856|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29857|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29858|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29859|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29860|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29914|NCT02447029|E1|Reported Event|Active Comparator|"Drug: vaginal 2% Xylocaine~vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block"
29915|NCT02446990|B3|Baseline|Total|Total of all reporting groups
29861|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29862|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29863|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29864|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29865|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29866|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29867|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29868|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29869|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29870|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29916|NCT02446990|B2|Baseline|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
30224|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
29871|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29872|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29873|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29874|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29875|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29876|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29877|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29878|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29879|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29880|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29917|NCT02446990|B1|Baseline|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
30225|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
29881|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29882|NCT02447432|E2|Reported Event|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29883|NCT02447432|E1|Reported Event|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
29884|NCT02447328|B1|Baseline|Single Arm|fulvestrant (Faslodex®)
29885|NCT02447328|P1|Participant Flow|Single Arm|fulvestrant (Faslodex®)
29886|NCT02447328|O1|Outcome|Single Arm|fulvestrant (Faslodex®)
29887|NCT02447328|E1|Reported Event|Single Arm|fulvestrant (Faslodex®)
29888|NCT02447133|B1|Baseline|Subjects Presenting With Normal Eyes|"Subjects with no known ocular diseases will be scanned on the Maestro device~3D OCT-1 Maestro: OCT Machine used for diagnostic purposes"
29889|NCT02447133|P1|Participant Flow|Subjects Presenting With Normal Eyes|"Subjects with no known ocular diseases will be scanned on the Maestro device~3D OCT-1 Maestro: OCT Machine used for diagnostic purposes"
29890|NCT02447133|O3|Outcome|6x6 Disc Scan|TopQ of 6x6 Disc Scan
29891|NCT02447133|O2|Outcome|6x6 Macula Scan|TopQ of 6x6 Macular Scan
29892|NCT02447133|O1|Outcome|12x9 Wide Scan|TopQ of 12x9 Wide Scan
29893|NCT02447133|E1|Reported Event|Subjects Presenting With Normal Eyes|"Subjects with no known ocular diseases will be scanned on the Maestro device~3D OCT-1 Maestro: OCT Machine used for diagnostic purposes"
29894|NCT02447029|B3|Baseline|Total|Total of all reporting groups
29895|NCT02447029|B2|Baseline|Standard Lidocaine Paracervical Block|"standard lidocaine paracervical block~standard lidocaine paracervical block: 1% lidocaine paracervical injection"
29896|NCT02447029|B1|Baseline|Active Comparator|"Drug: vaginal 2% Xylocaine~vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block"
29897|NCT02447029|P2|Participant Flow|Standard Lidocaine Paracervical Block|"standard lidocaine paracervical block~standard lidocaine paracervical block: 1% lidocaine paracervical injection"
29898|NCT02447029|P1|Participant Flow|Active Comparator|"Drug: vaginal 2% Xylocaine~vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block"
29899|NCT02447029|O2|Outcome|Standard Lidocaine Paracervical Block|"standard lidocaine paracervical block~standard lidocaine paracervical block: 1% lidocaine paracervical injection"
29900|NCT02447029|O1|Outcome|Active Comparator|"Drug: vaginal 2% Xylocaine~vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block"
29901|NCT02447029|O2|Outcome|Standard Lidocaine Paracervical Block|"standard lidocaine paracervical block~standard lidocaine paracervical block: 1% lidocaine paracervical injection"
29902|NCT02447029|O1|Outcome|Active Comparator|"Drug: vaginal 2% Xylocaine~vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block"
29903|NCT02447029|O2|Outcome|Standard Lidocaine Paracervical Block|"standard lidocaine paracervical block~standard lidocaine paracervical block: 1% lidocaine paracervical injection"
29904|NCT02447029|O1|Outcome|Active Comparator|"Drug: vaginal 2% Xylocaine~vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block"
29905|NCT02447029|O2|Outcome|Standard Lidocaine Paracervical Block|"standard lidocaine paracervical block~standard lidocaine paracervical block: 1% lidocaine paracervical injection"
29906|NCT02447029|O1|Outcome|Active Comparator|"Drug: vaginal 2% Xylocaine~vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block"
29907|NCT02447029|O2|Outcome|Standard Lidocaine Paracervical Block|"standard lidocaine paracervical block~standard lidocaine paracervical block: 1% lidocaine paracervical injection"
29908|NCT02447029|O1|Outcome|Active Comparator|"Drug: vaginal 2% Xylocaine~vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block"
29909|NCT02447029|O2|Outcome|Standard Lidocaine Paracervical Block|"standard lidocaine paracervical block~standard lidocaine paracervical block: 1% lidocaine paracervical injection"
29910|NCT02447029|O1|Outcome|Active Comparator|"Drug: vaginal 2% Xylocaine~vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block"
29911|NCT02447029|O2|Outcome|Standard Lidocaine Paracervical Block|"standard lidocaine paracervical block~standard lidocaine paracervical block: 1% lidocaine paracervical injection"
29912|NCT02447029|O1|Outcome|Active Comparator|"Drug: vaginal 2% Xylocaine~vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block"
30210|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
29918|NCT02446990|P2|Participant Flow|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29919|NCT02446990|P1|Participant Flow|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29920|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29921|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29922|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29923|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29924|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29925|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29926|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29927|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29928|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29929|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29930|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29931|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29932|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29933|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29934|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29935|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29936|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29937|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29938|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29939|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29940|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29941|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29942|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29943|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29944|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29945|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29946|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29947|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29948|NCT02446990|E2|Reported Event|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29949|NCT02446990|E1|Reported Event|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
29950|NCT02446743|B3|Baseline|Total|Total of all reporting groups
29951|NCT02446743|B2|Baseline|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
29952|NCT02446743|B1|Baseline|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 and at 0,1 month schedule in study V72_41, and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
29953|NCT02446743|P2|Participant Flow|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
29954|NCT02446743|P1|Participant Flow|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 and at 0,1 month schedule in study V72_41, and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
29955|NCT02446743|O3|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
29956|NCT02446743|O2|Outcome|Group B_0_1 (V72P10)|Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
29957|NCT02446743|O1|Outcome|Group B_0_1 (V72_41)|Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
29958|NCT02446743|O3|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
29959|NCT02446743|O2|Outcome|Group B_0_1 (V72P10)|Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
29960|NCT02446743|O1|Outcome|Group B_0_1 (V72_41)|Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
29961|NCT02446743|O3|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
29962|NCT02446743|O2|Outcome|Group B_0_1 (V72P10)|Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
29963|NCT02446743|O1|Outcome|Group B_0_1 (V72_41)|Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
29964|NCT02446743|O3|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
29965|NCT02446743|O2|Outcome|Group B_0_1 (V72P10)|Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
29966|NCT02446743|O1|Outcome|Group B_0_1 (V72_41)|Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
29967|NCT02446743|O3|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
29968|NCT02446743|O2|Outcome|Group B_0_1 (V72P10)|Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
29969|NCT02446743|O1|Outcome|Group B_0_1 (V72_41)|Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
29970|NCT02446743|O3|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
29971|NCT02446743|O2|Outcome|Group B_0_1 (V72P10)|Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
29972|NCT02446743|O1|Outcome|Group B_0_1 (V72_41)|Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
29973|NCT02446743|O6|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
29974|NCT02446743|O5|Outcome|Group B_0_1 (V72P10)|Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
29975|NCT02446743|O4|Outcome|Group B_0_1 (V72_41)|Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
29976|NCT02446743|O3|Outcome|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
29977|NCT02446743|O2|Outcome|Group 3B (V72P10)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
39943|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
29978|NCT02446743|O1|Outcome|Group 3B (V72_41)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
29979|NCT02446743|O6|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
29980|NCT02446743|O5|Outcome|Group B_0_1 (V72P10)|Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
29981|NCT02446743|O4|Outcome|Group B_0_1 (V72_41)|Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
29982|NCT02446743|O3|Outcome|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
29983|NCT02446743|O2|Outcome|Group 3B (V72P10)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
29984|NCT02446743|O1|Outcome|Group 3B (V72_41)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
29985|NCT02446743|O6|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
29986|NCT02446743|O5|Outcome|Group B_0_1 (V72P10)|Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
29987|NCT02446743|O4|Outcome|Group B_0_1 (V72_41)|Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
29988|NCT02446743|O3|Outcome|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
29989|NCT02446743|O2|Outcome|Group 3B (V72P10)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
29990|NCT02446743|O1|Outcome|Group 3B (V72_41)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
29991|NCT02446743|O6|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
29992|NCT02446743|O5|Outcome|Group B_0_1 (V72P10)|Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
29993|NCT02446743|O4|Outcome|Group B_0_1 (V72_41)|Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
29994|NCT02446743|O3|Outcome|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
29995|NCT02446743|O2|Outcome|Group 3B (V72P10)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
29996|NCT02446743|O1|Outcome|Group 3B (V72_41)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
29997|NCT02446743|O6|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
29998|NCT02446743|O5|Outcome|Group B_0_1 (V72P10)|Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
29999|NCT02446743|O4|Outcome|Group B_0_1 (V72_41)|Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
30211|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
30000|NCT02446743|O3|Outcome|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30001|NCT02446743|O2|Outcome|Group 3B (V72P10)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30002|NCT02446743|O1|Outcome|Group 3B (V72_41)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30003|NCT02446743|O6|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
30004|NCT02446743|O5|Outcome|Group B_0_1 (V72P10)|Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
30005|NCT02446743|O4|Outcome|Group B_0_1 (V72_41)|Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
30006|NCT02446743|O3|Outcome|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30007|NCT02446743|O2|Outcome|Group 3B (V72P10)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30008|NCT02446743|O1|Outcome|Group 3B (V72_41)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30009|NCT02446743|O6|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
30010|NCT02446743|O5|Outcome|Group B_0_1 (V72P10)|Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
30011|NCT02446743|O4|Outcome|Group B_0_1 (V72_41)|Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
30012|NCT02446743|O3|Outcome|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30013|NCT02446743|O2|Outcome|Group 3B (V72P10)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30014|NCT02446743|O1|Outcome|Group 3B (V72_41)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30015|NCT02446743|O6|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
30016|NCT02446743|O5|Outcome|Group B_0_1 (V72P10)|Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
30017|NCT02446743|O4|Outcome|Group B_0_1 (V72_41)|Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
30018|NCT02446743|O3|Outcome|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30019|NCT02446743|O2|Outcome|Group 3B (V72P10)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30020|NCT02446743|O1|Outcome|Group 3B (V72_41)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30212|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
39944|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
30021|NCT02446743|O6|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
30022|NCT02446743|O5|Outcome|Group B_0_1 (V72P10)|Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
30023|NCT02446743|O4|Outcome|Group B_0_1 (V72_41)|Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
30024|NCT02446743|O3|Outcome|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30025|NCT02446743|O2|Outcome|Group 3B (V72P10)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30026|NCT02446743|O1|Outcome|Group 3B (V72_41)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30027|NCT02446743|O6|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
30028|NCT02446743|O5|Outcome|Group B_0_1 (V72P10)|Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
30029|NCT02446743|O4|Outcome|Group B_0_1 (V72_41)|Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
30030|NCT02446743|O3|Outcome|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30031|NCT02446743|O2|Outcome|Group 3B (V72P10)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30032|NCT02446743|O1|Outcome|Group 3B (V72_41)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30033|NCT02446743|O6|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
30034|NCT02446743|O5|Outcome|Group B_0_1 (V72P10)|Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
30035|NCT02446743|O4|Outcome|Group B_0_1 (V72_41)|Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
30036|NCT02446743|O3|Outcome|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30037|NCT02446743|O2|Outcome|Group 3B (V72P10)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30038|NCT02446743|O1|Outcome|Group 3B (V72_41)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30039|NCT02446743|O6|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
30040|NCT02446743|O5|Outcome|Group B_0_1 (V72P10)|Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
30041|NCT02446743|O4|Outcome|Group B_0_1 (V72_41)|Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
30042|NCT02446743|O3|Outcome|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30213|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
30043|NCT02446743|O2|Outcome|Group 3B (V72P10)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30044|NCT02446743|O1|Outcome|Group 3B (V72_41)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30045|NCT02446743|O2|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
30046|NCT02446743|O1|Outcome|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30047|NCT02446743|O2|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
30048|NCT02446743|O1|Outcome|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30049|NCT02446743|O2|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
30050|NCT02446743|O1|Outcome|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30051|NCT02446743|O3|Outcome|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30052|NCT02446743|O2|Outcome|Group 3B (V72P10)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30053|NCT02446743|O1|Outcome|Group 3B (V72_41)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30054|NCT02446743|O6|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
30055|NCT02446743|O5|Outcome|Group B_0_1 (V72P10)|Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
30056|NCT02446743|O4|Outcome|Group B_0_1 (V72_41)|Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
30057|NCT02446743|O3|Outcome|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30058|NCT02446743|O2|Outcome|Group 3B (V72P10)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30059|NCT02446743|O1|Outcome|Group 3B (V72_41)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30060|NCT02446743|O6|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
30061|NCT02446743|O5|Outcome|Group B_0_1 (V72P10)|Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
30062|NCT02446743|O4|Outcome|Group B_0_1 (V72_41)|Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
30063|NCT02446743|O3|Outcome|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30214|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
30064|NCT02446743|O2|Outcome|Group 3B (V72P10)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30065|NCT02446743|O1|Outcome|Group 3B (V72_41)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30066|NCT02446743|O6|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
30067|NCT02446743|O5|Outcome|Group B_0_1 (V72P10)|Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
30068|NCT02446743|O4|Outcome|Group B_0_1 (V72_41)|Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
30069|NCT02446743|O3|Outcome|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30070|NCT02446743|O2|Outcome|Group 3B (V72P10)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30071|NCT02446743|O1|Outcome|Group 3B (V72_41)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30072|NCT02446743|O6|Outcome|Group B_0_1|Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
30073|NCT02446743|O5|Outcome|Group B_0_1 (V72P10)|Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
30074|NCT02446743|O4|Outcome|Group B_0_1 (V72_41)|Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
30075|NCT02446743|O3|Outcome|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30076|NCT02446743|O2|Outcome|Group 3B (V72P10)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30077|NCT02446743|O1|Outcome|Group 3B (V72_41)|Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30078|NCT02446743|E2|Reported Event|Group B_0_1|Naive subjects from V72_41 or V72P10 studies, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
30079|NCT02446743|E1|Reported Event|Group 3B|Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 month schedule in studies V72_41 or V72P10, and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.
30080|NCT02446717|B6|Baseline|Total|Total of all reporting groups
30081|NCT02446717|B5|Baseline|ARM E|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 16 weeks in HCV genotype 1- or 4-6- infected participants with or without cirrhosis.
30082|NCT02446717|B4|Baseline|ARM D|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks in HCV genotypes 1- or 4-6- infected participants with or without cirrhosis.
30083|NCT02446717|B3|Baseline|ARM C|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
30084|NCT02446717|B2|Baseline|ARM B|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus ribavirin (RBV) for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
30085|NCT02446717|B1|Baseline|ARM A|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
30086|NCT02446717|P5|Participant Flow|ARM E|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 16 weeks in HCV genotype 1- or 4-6- infected participants with or without cirrhosis.
30087|NCT02446717|P4|Participant Flow|ARM D|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks in HCV genotypes 1- or 4-6- infected participants with or without cirrhosis.
30088|NCT02446717|P3|Participant Flow|ARM C|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
30089|NCT02446717|P2|Participant Flow|ARM B|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus ribavirin (RBV) for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
30090|NCT02446717|P1|Participant Flow|ARM A|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
30091|NCT02446717|O5|Outcome|ARM E|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 16 weeks in HCV genotype 1- or 4-6- infected participants with or without cirrhosis.
30092|NCT02446717|O4|Outcome|ARM D|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks in HCV genotypes 1- or 4-6- infected participants with or without cirrhosis.
30093|NCT02446717|O3|Outcome|ARM C|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
30094|NCT02446717|O2|Outcome|ARM B|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus ribavirin (RBV) for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
30095|NCT02446717|O1|Outcome|ARM A|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
30096|NCT02446717|O5|Outcome|ARM E|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 16 weeks in HCV genotype 1- or 4-6- infected participants with or without cirrhosis.
30097|NCT02446717|O4|Outcome|ARM D|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks in HCV genotypes 1- or 4-6- infected participants with or without cirrhosis.
30098|NCT02446717|O3|Outcome|ARM C|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
30099|NCT02446717|O2|Outcome|ARM B|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus ribavirin (RBV) for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
30100|NCT02446717|O1|Outcome|ARM A|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
30101|NCT02446717|O5|Outcome|ARM E|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 16 weeks in HCV genotype 1- or 4-6- infected participants with or without cirrhosis.
30102|NCT02446717|O4|Outcome|ARM D|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks in HCV genotypes 1- or 4-6- infected participants with or without cirrhosis.
30103|NCT02446717|O3|Outcome|ARM C|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
30104|NCT02446717|O2|Outcome|ARM B|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus ribavirin (RBV) for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
30105|NCT02446717|O1|Outcome|ARM A|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
30106|NCT02446717|O5|Outcome|ARM E|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 16 weeks in HCV genotype 1- or 4-6- infected participants with or without cirrhosis.
30107|NCT02446717|O4|Outcome|ARM D|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks in HCV genotypes 1- or 4-6- infected participants with or without cirrhosis.
30108|NCT02446717|O3|Outcome|ARM C|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
30109|NCT02446717|O2|Outcome|ARM B|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus ribavirin (RBV) for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
30110|NCT02446717|O1|Outcome|ARM A|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
30111|NCT02446717|E5|Reported Event|ARM E|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 16 weeks in HCV genotype 1- or 4-6- infected participants with or without cirrhosis.
30112|NCT02446717|E4|Reported Event|ARM D|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks in HCV genotypes 1- or 4-6- infected participants with or without cirrhosis.
30113|NCT02446717|E3|Reported Event|ARM C|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
30114|NCT02446717|E2|Reported Event|ARM B|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus ribavirin (RBV) for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
30115|NCT02446717|E1|Reported Event|ARM A|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
30116|NCT02446613|B3|Baseline|Total|Total of all reporting groups
30117|NCT02446613|B2|Baseline|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
30118|NCT02446613|B1|Baseline|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
30119|NCT02446613|P2|Participant Flow|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 nanograms (ng), i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post NAC.
30120|NCT02446613|P1|Participant Flow|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to nasal allergen challenge (NAC) at Visit 2 to investigate the long term effect of matching placebo, intranasal (i.n.), administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 hours (h) post NAC.
30215|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
30216|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
30121|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
30122|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
30123|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958) . Total and individual nasal sym. were recorded up to 6 h post-NAC.
30124|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
30125|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
30126|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
30127|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958) . Total and individual nasal sym. were recorded up to 6 h post-NAC.
30128|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
30129|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958) . Total and individual nasal sym were recorded up to 6 h post-NAC.
30130|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym were recorded up to 6 h post-NAC.
30131|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym were recorded up to 6 h post-NAC.
30132|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym were recorded up to 6 h post-NAC.
30133|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym were recorded up to 6 h post-NAC.
30134|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
30135|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958) . Total and individual nasal sym. were recorded up to 6 h post-NAC.
30136|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
30137|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
30138|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
30139|NCT02446613|E2|Reported Event|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
30217|NCT02446171|O1|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
30218|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
30140|NCT02446613|E1|Reported Event|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
30141|NCT02446496|B1|Baseline|Treatment A-cefadroxil 1 gm + Treatment B-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gram [gm] film coated [F.C.] tablet) or treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 ante meridiem (am) and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
30142|NCT02446496|P1|Participant Flow|Treatment A-cefadroxil 1 gm + Treatment B-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gram [gm] film coated [F.C.] tablet) or treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 ante meridiem (am) and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
30143|NCT02446496|O2|Outcome|Treatment B-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
30144|NCT02446496|O1|Outcome|Treatment A-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
30145|NCT02446496|O2|Outcome|Treatment B-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
30146|NCT02446496|O1|Outcome|Treatment A-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
30147|NCT02446496|O2|Outcome|Treatment B-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
30148|NCT02446496|O1|Outcome|Treatment A-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
30149|NCT02446496|O2|Outcome|Treatment B-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
30150|NCT02446496|O1|Outcome|Treatment A-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
30151|NCT02446496|E2|Reported Event|Treatment B-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
30152|NCT02446496|E1|Reported Event|Treatment A-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
30153|NCT02446483|B1|Baseline|Treatment A-rabeprazole 20 mg + Treatment B-rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment A (rabeprazole 20 mg enteric coated tablet) or treatment B (rabeprazole 20 mg gastro-resistant tablet), given with 240 mL water according to a plan of randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
30154|NCT02446483|P2|Participant Flow|Treatment B-rabeprazole 20mg,Then Treatment A-rabeprazole 20mg|Participants received one tablet of treatment B (rabeprazole 20 mg gastro-resistant tablet) given with 240 mL water according to a plan of randomization. Water was at room temperature and measured with a 250 mL cylinder. After a washout period of 7 days, participants then received one tablet of treatment A (rabeprazole 20 mg enteric coated tablet) given with 240 mL water. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period.
30155|NCT02446483|P1|Participant Flow|Treatment A-rabeprazole 20mg,Then Treatment B-rabeprazole 20mg|Participants received one tablet of treatment A (rabeprazole 20 milligram [mg] enteric coated tablet) given with 240 milliliter (mL) water according to a plan of randomization. Water was at room temperature and measured with a 250 mL cylinder. After a washout period of 7 days, participants then received one tablet of treatment B (rabeprazole 20 mg gastro-resistant tablet) given with 240 mL water. Participants were admitted the night before study drug administration, supervised for at least 10 hours (h) of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 ante meridiem (am) and 10:51 am on Day 1 of each study period.
30156|NCT02446483|O2|Outcome|Treatment B- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment B (rabeprazole 20 mg gastro-resistant tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
30157|NCT02446483|O1|Outcome|Treatment A- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment A (rabeprazole 2 mg enteric coated tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
30158|NCT02446483|O2|Outcome|Treatment B- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment B (rabeprazole 20 mg gastro-resistant tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
30159|NCT02446483|O1|Outcome|Treatment A- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment A (rabeprazole 2 mg enteric coated tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
30160|NCT02446483|O2|Outcome|Treatment B- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment B (rabeprazole 20 mg gastro-resistant tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
30161|NCT02446483|O1|Outcome|Treatment A- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment A (rabeprazole 2 mg enteric coated tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
30162|NCT02446483|O2|Outcome|Treatment B- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment B (rabeprazole 20 mg gastro-resistant tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
30163|NCT02446483|O1|Outcome|Treatment A- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment A (rabeprazole 2 mg enteric coated tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
30219|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
30226|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
30164|NCT02446483|E2|Reported Event|Treatment B- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment B (rabeprazole 20 mg gastro-resistant tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
30165|NCT02446483|E1|Reported Event|Treatment A- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment A (rabeprazole 2 mg enteric coated tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
30166|NCT02446171|B5|Baseline|Total|Total of all reporting groups
30167|NCT02446171|B4|Baseline|DCAB Sequence|Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4.
30168|NCT02446171|B3|Baseline|CBDA Sequence|Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4.
30169|NCT02446171|B2|Baseline|BACD Sequence|Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4.
30170|NCT02446171|B1|Baseline|ADBC Sequence|Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4.
30171|NCT02446171|P4|Participant Flow|DCAB Sequence|Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4.
30172|NCT02446171|P3|Participant Flow|CBDA Sequence|Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4.
30173|NCT02446171|P2|Participant Flow|BACD Sequence|Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4.
30174|NCT02446171|P1|Participant Flow|ADBC Sequence|Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4.
30175|NCT02446171|O2|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
30176|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
30177|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
30178|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
30179|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
30180|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
30181|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
30182|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
30183|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
30184|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
30185|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
30186|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
30187|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
30188|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
30189|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
30190|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
30191|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
30192|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
30193|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
30194|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
30195|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
30196|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
30197|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
30198|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
30199|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
30200|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
30201|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
30202|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
30203|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
30204|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
30205|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
30206|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
30207|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
30208|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
30209|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
30228|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
30229|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
30230|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
30231|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
30232|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
30233|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
30234|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
30235|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
30236|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
30237|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
30238|NCT02446171|E4|Reported Event|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
30239|NCT02446171|E3|Reported Event|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
30240|NCT02446171|E2|Reported Event|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
30241|NCT02446171|E1|Reported Event|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
30242|NCT02446015|B3|Baseline|Total|Total of all reporting groups
30243|NCT02446015|B2|Baseline|Systane Ultra PRN|SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye PRN for 28 days
30244|NCT02446015|B1|Baseline|Systane Ultra QID|SYSTANE® ULTRA lubricant eye drops,1 drop in each eye QID for 28 days
30245|NCT02446015|P2|Participant Flow|Systane Ultra PRN|SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye, as needed (PRN) for 28 days
30246|NCT02446015|P1|Participant Flow|Systane Ultra QID|SYSTANE® ULTRA lubricant eye drops,1 drop in each eye, 4 times per day (QID) for 28 days
30247|NCT02446015|O2|Outcome|Systane Ultra PRN|SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye PRN for 28 days
30248|NCT02446015|O1|Outcome|Systane Ultra QID|SYSTANE® ULTRA lubricant eye drops,1 drop in each eye QID for 28 days
30249|NCT02446015|O2|Outcome|Systane Ultra PRN|SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye PRN for 28 days
30250|NCT02446015|O1|Outcome|Systane Ultra QID|SYSTANE® ULTRA lubricant eye drops,1 drop in each eye QID for 28 days
30251|NCT02446015|O2|Outcome|Systane Ultra PRN|SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye PRN for 28 days
30252|NCT02446015|O1|Outcome|Systane Ultra QID|SYSTANE® ULTRA lubricant eye drops,1 drop in each eye QID for 28 days
30253|NCT02446015|E3|Reported Event|Systane Ultra PRN|All subjects treated with SYSTANE® ULTRA lubricant eye drops PRN
30254|NCT02446015|E2|Reported Event|Systane Ultra QID|All subjects treated with SYSTANE® ULTRA lubricant eye drops QID
30255|NCT02446015|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
30256|NCT02445807|B3|Baseline|Total|Total of all reporting groups
30257|NCT02445807|B2|Baseline|Vehicle Cream|"Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.~Vehicle Cream: Twice daily topical application for 14 days."
30258|NCT02445807|B1|Baseline|DFD-06 Cream|"DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.~DFD06-Cream: Twice daily topical application for 14 days."
30259|NCT02445807|P2|Participant Flow|Vehicle Cream|"Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.~Vehicle Cream: Twice daily topical application for 14 days."
30260|NCT02445807|P1|Participant Flow|DFD-06 Cream|"DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.~DFD06-Cream: Twice daily topical application for 14 days."
30261|NCT02445807|O2|Outcome|Vehicle Cream|"Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.~Vehicle Cream: Twice daily topical application for 14 days."
30262|NCT02445807|O1|Outcome|DFD-06 Cream|"DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.~DFD06-Cream: Twice daily topical application for 14 days."
30263|NCT02445807|O2|Outcome|Vehicle Cream|"Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.~Vehicle Cream: Twice daily topical application for 14 days."
30264|NCT02445807|O1|Outcome|DFD-06 Cream|"DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.~DFD06-Cream: Twice daily topical application for 14 days."
30265|NCT02445807|O2|Outcome|Vehicle Cream|"Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.~Vehicle Cream: Twice daily topical application for 14 days."
30266|NCT02445807|O1|Outcome|DFD-06 Cream|"DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.~DFD06-Cream: Twice daily topical application for 14 days."
30267|NCT02445807|E2|Reported Event|Vehicle Cream|"Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.~Vehicle Cream: Twice daily topical application for 14 days."
30268|NCT02445807|E1|Reported Event|DFD-06 Cream|"DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.~DFD06-Cream: Twice daily topical application for 14 days."
30269|NCT02445755|B1|Baseline|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
30270|NCT02445755|P1|Participant Flow|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
30271|NCT02445755|O4|Outcome|Total Serum Bilirubin (TSB)|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured routinely for total serum bilirubin by diazo method.
30272|NCT02445755|O3|Outcome|JM103 TcB|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with the JM103 TcB device
30915|NCT02440308|B1|Baseline|68Ga-DOTA-Bombesin PET/MRI|Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
30273|NCT02445755|O2|Outcome|BiliCare TcB With Infection Control Tip|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with the BiliCare TcB device with infection control tip.
30274|NCT02445755|O1|Outcome|BiliCare TcB|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with the BiliCare TcB device
30275|NCT02445755|E1|Reported Event|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
30276|NCT02445573|B3|Baseline|Total|Total of all reporting groups
30277|NCT02445573|B2|Baseline|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
30278|NCT02445573|B1|Baseline|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
30279|NCT02445573|P2|Participant Flow|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
30280|NCT02445573|P1|Participant Flow|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 milliampere (mA) for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
30281|NCT02445573|O2|Outcome|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
30282|NCT02445573|O1|Outcome|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
30283|NCT02445573|O2|Outcome|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
30284|NCT02445573|O1|Outcome|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
30285|NCT02445573|O2|Outcome|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
30314|NCT02445287|B1|Baseline|Predicate & Invest.- Cadavers 2D & 3D|Cadaveric specimens will be imaged with 2D predicate device CARESTREAM DRX-1 GOS general radiograph and 2D investigational device CARESTREAM CBCT general radiograph. Cadaveric specimens will be imaged with 3D reference device Phillips MDCT and 3D investigational device CARESTREAM CBCT.
30286|NCT02445573|O1|Outcome|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
30287|NCT02445573|O2|Outcome|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
30288|NCT02445573|O1|Outcome|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
30289|NCT02445573|O2|Outcome|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
30290|NCT02445573|O1|Outcome|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
30291|NCT02445573|E2|Reported Event|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
30292|NCT02445573|E1|Reported Event|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
30293|NCT02445326|B3|Baseline|Total|Total of all reporting groups
30294|NCT02445326|B2|Baseline|Placebo Vehicle|PV (placebo drug delivery vehicle)
30295|NCT02445326|B1|Baseline|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
30296|NCT02445326|P2|Participant Flow|Placebo Vehicle|PV (placebo drug delivery vehicle)
30297|NCT02445326|P1|Participant Flow|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
30298|NCT02445326|O2|Outcome|Placebo Vehicle|PV (placebo drug delivery vehicle)
30299|NCT02445326|O1|Outcome|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
30300|NCT02445326|O2|Outcome|Placebo Vehicle|PV (placebo drug delivery vehicle)
30301|NCT02445326|O1|Outcome|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
30302|NCT02445326|O2|Outcome|Placebo Vehicle|PV (placebo drug delivery vehicle)
30303|NCT02445326|O1|Outcome|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
30304|NCT02445326|O2|Outcome|Placebo Vehicle|PV (placebo drug delivery vehicle)
30305|NCT02445326|O1|Outcome|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
30306|NCT02445326|O2|Outcome|Placebo Vehicle|PV (placebo drug delivery vehicle)
30307|NCT02445326|O1|Outcome|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
30308|NCT02445326|O2|Outcome|Placebo Vehicle|PV (placebo drug delivery vehicle)
30309|NCT02445326|O1|Outcome|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
30310|NCT02445326|E2|Reported Event|Placebo Vehicle|PV (placebo drug delivery vehicle)
30311|NCT02445326|E1|Reported Event|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
30312|NCT02445287|B3|Baseline|Total|Total of all reporting groups
30313|NCT02445287|B2|Baseline|Investigational - Human Subjects 3D|Human subjects will be imaged with 3D investigational device CARESTREAM CBCT only.
30315|NCT02445287|P2|Participant Flow|Investigational - Human Subjects 3D|Human subjects will be imaged with 3D investigational device CARESTREAM Cone Beam Computed Tomography (CBCT) only.
30316|NCT02445287|P1|Participant Flow|Predicate & Invest.- Cadavers 2D & 3D|Cadaveric specimens will be imaged with 2D devices CARESTREAM DRX-Evolution general radiograph and CARESTREAM Cone Beam Computed Tomography (CBCT) general radiograph, and 3D devices PHILLIPS Multi Detector Computed Tomography (MDCT) and CARESTREAM Cone Beam Computed Tomography (CBCT).
30317|NCT02445287|O2|Outcome|Invest. - Cadavers & Human Subjects 3D - SND|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
30318|NCT02445287|O1|Outcome|Reference - Cadavers 3D|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
30319|NCT02445287|O2|Outcome|Invest. - Cadavers & Human Subjects 3D - FDK|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
30320|NCT02445287|O1|Outcome|Reference - Cadavers 3D|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
30321|NCT02445287|O2|Outcome|Invest. - Cadavers & Human Subjects 3D - High Res|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
30322|NCT02445287|O1|Outcome|Reference - Cadavers 3D|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
30323|NCT02445287|O2|Outcome|Investigational - Cadavers 2D|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
30337|NCT02445196|O1|Outcome|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
30916|NCT02440308|P1|Participant Flow|68Ga-DOTA-Bombesin PET/MRI|Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
30324|NCT02445287|O1|Outcome|Predicate - Cadavers 2D|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
30325|NCT02445287|E3|Reported Event|Investigational - Human Subjects 3D|Human subjects will be imaged with 3D investigational device CARESTREAM CBCT only.
30326|NCT02445287|E2|Reported Event|Reference & Invest. - Cadavers 3D|Cadaveric specimens will be imaged with 3D reference device Phillips MDCT and 3D investigational device CARESTREAM CBCT.
30327|NCT02445287|E1|Reported Event|Predicate & Invest.- Cadavers 2D|Cadaveric specimens will be imaged with 2D predicate device CARESTREAM DRX-1 GOS general radiograph and 2D investigational device CARESTREAM CBCT general radiograph.
30328|NCT02445196|B3|Baseline|Total|Total of all reporting groups
30329|NCT02445196|B2|Baseline|Waitlist Control|"Subjects assigned to this condition are told: You have been randomly assigned to Group 2, the group that does not use the app.~Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
30330|NCT02445196|B1|Baseline|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
30331|NCT02445196|P2|Participant Flow|Waitlist Control|"Subjects assigned to this condition are told: You have been randomly assigned to Group 2, the group that does not use the app.~Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
30332|NCT02445196|P1|Participant Flow|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
30333|NCT02445196|O1|Outcome|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
30334|NCT02445196|O2|Outcome|Waitlist Control|"Subjects assigned to this condition are told: You have been randomly assigned to Group 2, the group that does not use the app.~Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
30335|NCT02445196|O1|Outcome|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
30336|NCT02445196|O2|Outcome|Waitlist Control|"Subjects assigned to this condition are told: You have been randomly assigned to Group 2, the group that does not use the app.~Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
30338|NCT02445196|O2|Outcome|Waitlist Control|"Subjects assigned to this condition are told: You have been randomly assigned to Group 2, the group that does not use the app.~Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
30339|NCT02445196|O1|Outcome|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
30340|NCT02445196|O2|Outcome|Waitlist Control|"Subjects assigned to this condition are told: You have been randomly assigned to Group 2, the group that does not use the app.~Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
30341|NCT02445196|O1|Outcome|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
30342|NCT02445196|E2|Reported Event|Waitlist Control|"Subjects assigned to this condition are told: You have been randomly assigned to Group 2, the group that does not use the app.~Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
30343|NCT02445196|E1|Reported Event|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
30344|NCT02444936|B3|Baseline|Total|Total of all reporting groups
30345|NCT02444936|B2|Baseline|Control|There is no drug given in this arm.
30346|NCT02444936|B1|Baseline|ZOSTAVAX|"ZOSTAVAX shingles vaccine Zoster vaccine live Single 0.65mL subcutaneous injection~ZOSTAVAX: Shingles vaccine"
30347|NCT02444936|P2|Participant Flow|Control|There is no drug given in this arm.
30348|NCT02444936|P1|Participant Flow|ZOSTAVAX|"ZOSTAVAX shingles vaccine Zoster vaccine live Single 0.65mL subcutaneous injection~ZOSTAVAX: Shingles vaccine"
30349|NCT02444936|O2|Outcome|Control|There is no drug given in this arm.
30350|NCT02444936|O1|Outcome|ZOSTAVAX|"ZOSTAVAX shingles vaccine Zoster vaccine live Single 0.65mL subcutaneous injection~ZOSTAVAX: Shingles vaccine"
30351|NCT02444936|E2|Reported Event|Control|There is no drug given in this arm.
30352|NCT02444936|E1|Reported Event|ZOSTAVAX|"ZOSTAVAX shingles vaccine Zoster vaccine live Single 0.65mL subcutaneous injection~ZOSTAVAX: Shingles vaccine"
30353|NCT02444715|B3|Baseline|Total|Total of all reporting groups
30354|NCT02444715|B2|Baseline|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
30355|NCT02444715|B1|Baseline|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
30356|NCT02444715|P2|Participant Flow|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
30357|NCT02444715|P1|Participant Flow|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
30358|NCT02444715|O1|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
30359|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
30360|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
30361|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
30362|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
30363|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
30364|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
30365|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
30429|NCT02443883|O1|Outcome|Ramucirumab Regimen 1|Ramucirumab (8 mg/kg) given IV on day 1 and day 15 of each cycle (28 day cycles) until discontinuation criteria are met.
30366|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
30367|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
30368|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
30369|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
30370|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
30371|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
30372|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
30373|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
30374|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
30375|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
30376|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
30377|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
30378|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
30379|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
30380|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
30381|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
30382|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
30383|NCT02444715|E2|Reported Event|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
30384|NCT02444715|E1|Reported Event|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
30385|NCT02444533|B3|Baseline|Total|Total of all reporting groups
30386|NCT02444533|B2|Baseline|No Treatment|Patient will not be given any medications in the tonsillar fossae after tonsillectomy
30387|NCT02444533|B1|Baseline|Liposomal Bupivacaine|"Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy~Liposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy."
30388|NCT02444533|P2|Participant Flow|No Treatment|Patient will not be given any medications in the tonsillar fossae after tonsillectomy
30389|NCT02444533|P1|Participant Flow|Liposomal Bupivacaine|"Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy~Liposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy."
30390|NCT02444533|O2|Outcome|No Treatment|Patient will not be given any medications in the tonsillar fossae after tonsillectomy
30391|NCT02444533|O1|Outcome|Liposomal Bupivacaine|"Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy~Liposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy."
30392|NCT02444533|O2|Outcome|No Treatment|Patient will not be given any medications in the tonsillar fossae after tonsillectomy
30393|NCT02444533|O1|Outcome|Liposomal Bupivacaine|"Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy~Liposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy."
30394|NCT02444533|O2|Outcome|No Treatment|Patient will not be given any medications in the tonsillar fossae after tonsillectomy
30395|NCT02444533|O1|Outcome|Liposomal Bupivacaine|"Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy~Liposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy."
30396|NCT02444533|O2|Outcome|No Treatment|Patient will not be given any medications in the tonsillar fossae after tonsillectomy
30397|NCT02444533|O1|Outcome|Liposomal Bupivacaine|"Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy~Liposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy."
30398|NCT02444533|O2|Outcome|No Treatment|Patient will not be given any medications in the tonsillar fossae after tonsillectomy
30759|NCT02442349|P1|Participant Flow|AZD9291 80mg|Daily single dose of AZD9291 80mg
30399|NCT02444533|O1|Outcome|Liposomal Bupivacaine|"Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy~Liposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy."
30400|NCT02444533|E2|Reported Event|No Treatment|Patient will not be given any medications in the tonsillar fossae after tonsillectomy
30401|NCT02444533|E1|Reported Event|Liposomal Bupivacaine|"Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy.~Liposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy."
30402|NCT02444182|B3|Baseline|Total|Total of all reporting groups
30403|NCT02444182|B2|Baseline|Control - No Probiotics|"Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece)~Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted"
30404|NCT02444182|B1|Baseline|Probiotics|"participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG~Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted"
30405|NCT02444182|P2|Participant Flow|Control - No Probiotics|"Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece)~Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted"
30406|NCT02444182|P1|Participant Flow|Probiotics|"participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG~Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted"
30407|NCT02444182|O2|Outcome|Control - No Probiotics|"Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece)~Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted"
30408|NCT02444182|O1|Outcome|Probiotics|"participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG~Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted"
30409|NCT02444182|O2|Outcome|Control - No Probiotics|"Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece)~Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted"
30410|NCT02444182|O1|Outcome|Probiotics|"participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG~Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted"
30411|NCT02444182|E2|Reported Event|Control - No Probiotics|"Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece)~Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted"
30412|NCT02444182|E1|Reported Event|Probiotics|"participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG~Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted"
30413|NCT02443883|B5|Baseline|Total|Total of all reporting groups
30414|NCT02443883|B4|Baseline|Ramucirumab Regimen 4|Ramucirumab (8 mg/kg) given IV on day 1 and day 8 of each cycle (21 day cycles) until discontinuation criteria are met.
30415|NCT02443883|B3|Baseline|Ramucirumab Regimen 3|Ramucirumab (6 mg/kg) given IV on day 1, 8, 15 and 22 of each cycle (28 day cycles) until discontinuation criteria are met.
30416|NCT02443883|B2|Baseline|Ramucirumab Regimen 2|Ramucirumab (12 mg/kg) given IV on day 1 and day 15 of each cycle (28 day cycles) until discontinuation criteria are met.
30417|NCT02443883|B1|Baseline|Ramucirumab Regimen 1|Ramucirumab (8 mg/kg) given IV on day 1 and day 15 of each cycle (28 day cycles) until discontinuation criteria are met.
30418|NCT02443883|P4|Participant Flow|Ramucirumab Regimen 4|Ramucirumab (8 mg/kg) given IV on day 1 and day 8 of each cycle (21 day cycles) until discontinuation criteria are met.
30419|NCT02443883|P3|Participant Flow|Ramucirumab Regimen 3|Ramucirumab (6 mg/kg) given IV on day 1, 8, 15 and 22 of each cycle (28 day cycles) until discontinuation criteria are met.
30420|NCT02443883|P2|Participant Flow|Ramucirumab Regimen 2|Ramucirumab (12 mg/kg) given IV on day 1 and day 15 of each cycle (28 day cycles) until discontinuation criteria are met.
30421|NCT02443883|P1|Participant Flow|Ramucirumab Regimen 1|Ramucirumab (8milligram per kilogram [mg/kg]) given intravenously (IV) on day 1 and day 15 of each cycle (28 day cycles) until discontinuation criteria are met.
30422|NCT02443883|O4|Outcome|Ramucirumab Regimen 4|Ramucirumab (8 mg/kg) given IV on day 1 and day 8 of each cycle (21 day cycles) until discontinuation criteria are met.
30423|NCT02443883|O3|Outcome|Ramucirumab Regimen 3|Ramucirumab (6 mg/kg) given IV on day 1, 8, 15 and 22 of each cycle (28 day cycles) until discontinuation criteria are met.
30424|NCT02443883|O2|Outcome|Ramucirumab Regimen 2|Ramucirumab (12 mg/kg) given IV on day 1 and day 15 of each cycle (28 day cycles) until discontinuation criteria are met.
30425|NCT02443883|O1|Outcome|Ramucirumab Regimen 1|Ramucirumab (8 mg/kg) given IV on day 1 and day 15 of each cycle (28 day cycles) until discontinuation criteria are met.
30426|NCT02443883|O4|Outcome|Ramucirumab Regimen 4|Ramucirumab (8 mg/kg) given IV on day 1 and day 8 of each cycle (21 day cycles) until discontinuation criteria are met.
30427|NCT02443883|O3|Outcome|Ramucirumab Regimen 3|Ramucirumab (6 mg/kg) given IV on day 1, 8, 15 and 22 of each cycle (28 day cycles) until discontinuation criteria are met.
30428|NCT02443883|O2|Outcome|Ramucirumab Regimen 2|Ramucirumab (12 mg/kg) given IV on day 1 and day 15 of each cycle (28 day cycles) until discontinuation criteria are met.
39945|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
30430|NCT02443883|O4|Outcome|Ramucirumab Regimen 4|Ramucirumab (8 mg/kg) given IV on day 1 and day 8 of each cycle (21 day cycles) until discontinuation criteria are met.
30431|NCT02443883|O3|Outcome|Ramucirumab Regimen 3|Ramucirumab (6 mg/kg) given IV on day 1, 8, 15 and 22 of each cycle (28 day cycles) until discontinuation criteria are met.
30432|NCT02443883|O2|Outcome|Ramucirumab Regimen 2|Ramucirumab (12 mg/kg) given IV on day 1 and day 15 of each cycle (28 day cycles) until discontinuation criteria are met.
30433|NCT02443883|O1|Outcome|Ramucirumab Regimen 1|Ramucirumab (8 mg/kg) given IV on day 1 and day 15 of each cycle (28 day cycles) until discontinuation criteria are met.
30434|NCT02443883|E4|Reported Event|Ramucirumab Regimen 4|Ramucirumab (8 mg/kg) given IV on day 1 and day 8 of each cycle (21 day cycles) until discontinuation criteria are met.
30435|NCT02443883|E3|Reported Event|Ramucirumab Regimen 3|Ramucirumab (6 mg/kg) given IV on day 1, 8, 15 and 22 of each cycle (28 day cycles) until discontinuation criteria are met.
30436|NCT02443883|E2|Reported Event|Ramucirumab Regimen 2|Ramucirumab (12 mg/kg) given IV on day 1 and day 15 of each cycle (28 day cycles) until discontinuation criteria are met.
30437|NCT02443883|E1|Reported Event|Ramucirumab Regimen 1|Ramucirumab (8 mg/kg) given IV on day 1 and day 15 of each cycle (28 day cycles) until discontinuation criteria are met.
30438|NCT02443792|B3|Baseline|Total|Total of all reporting groups
30439|NCT02443792|B2|Baseline|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
30440|NCT02443792|B1|Baseline|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
30441|NCT02443792|P2|Participant Flow|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
30442|NCT02443792|P1|Participant Flow|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
30443|NCT02443792|O2|Outcome|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
30444|NCT02443792|O1|Outcome|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
30445|NCT02443792|O2|Outcome|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
30446|NCT02443792|O1|Outcome|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
30447|NCT02443792|O2|Outcome|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
30448|NCT02443792|O1|Outcome|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
30449|NCT02443792|O2|Outcome|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
30450|NCT02443792|O1|Outcome|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
30451|NCT02443792|O2|Outcome|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
30452|NCT02443792|O1|Outcome|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
30453|NCT02443792|E2|Reported Event|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
30454|NCT02443792|E1|Reported Event|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
30455|NCT02443740|B5|Baseline|Total|Total of all reporting groups
30456|NCT02443740|B4|Baseline|Cohort 4|Participants received a single oral dose of PF-05251749 suspension on Day 1 of each Intervention Period (2 Intervention Periods of 3 days each). Participants received study treatment in following sequences: PF-05251749 500mg unmilled, PF-05251749 500mg milled and PF-05251749 500mg milled, PF-05251749 500mg unmilled in Intervention Period 1 and 2. All doses were administered in fasted state. A washout period of at least 7 days was maintained between each Intervention Period.
30457|NCT02443740|B3|Baseline|Cohort 3|Participants received a single oral dose of PF-05251749 500 mg suspension on Day 1. CSF samples were collected for a total of 10 hours beginning 2 hours predose and 8 hours post dose.
30458|NCT02443740|B2|Baseline|Cohort 2|Participants received a single oral dose of PF-05251749 suspension on Day 1 of each Intervention Period (4 Intervention Periods of 3 days each). Participants received study treatment in following sequences: PF-05251749 placebo, PF-05251749 100mg, PF-05251749 500mg, PF-05251749 1000mg; PF-05251749 10mg, PF-05251749 placebo, PF-05251749 500mg, PF-05251749 1000mg; PF-05251749 10mg, PF-05251749 100mg, PF-05251749 placebo, PF-05251749 1000mg and PF-05251749 10mg, PF-05251749 100mg, PF-05251749 500mg, PF-05251749 placebo in Intervention Period 1, 2, 3 and 4 respectively. All doses were administered in fasted state. A washout period of at least 7 days was maintained between each Intervention Period.
30459|NCT02443740|B1|Baseline|Cohort 1|Participants received a single oral dose of PF-05251749 suspension on Day 1 of each Intervention Period (4 Intervention Periods of 3 days each). Participants received study treatment in following sequences: Placebo, PF-05251749 30 mg, 250 mg and 500 mg; PF-05251749 3 mg, placebo, PF-05251749 250 mg and 500 mg; PF-05251749 3 mg, 30 mg, placebo and PF-05251749 500 mg; PF-05251749 3 mg, 30 mg, 250 mg and placebo in Intervention Period 1, 2, 3 and 4 respectively. All doses were administered in fasted state except PF-05251749 500 mg. A washout period of at least 7 days was maintained between each Intervention Period.
30460|NCT02443740|P11|Participant Flow|Cohort 4 PF-05251749: 500 mg Milled + 500 mg Unmilled|Participants received a single oral dose of PF-05251749 suspension on Day 1 of each Intervention Period (2 Intervention Periods of 3 days each). Participants received study treatment in following sequences: PF-05251749 500 mg milled, PF-05251749 500 mg unmilled in Intervention Period 1 and 2. All doses were administered in fasted state. A washout period of at least 7 days was maintained between each Intervention Period.
30461|NCT02443740|P10|Participant Flow|Cohort 4 PF-05251749: 500 mg Unmilled + 500 mg Milled|Participants received a single oral dose of PF-05251749 suspension on Day 1 of each Intervention Period (2 Intervention Periods of 3 days each). Participants received study treatment in following sequences: PF-05251749 500mg unmilled, PF-05251749 500mg milled in Intervention Period 1 and 2. All doses were administered in fasted state. A washout period of at least 7 days was maintained between each Intervention Period.
39946|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
30462|NCT02443740|P9|Participant Flow|Cohort 3 PF-05251749: 500 mg|Participants received a single oral dose of PF-05251749 500 mg suspension on Day 1. CSF samples were collected for a total of 10 hours beginning 2 hours predose and 8 hours post dose.
30463|NCT02443740|P8|Participant Flow|Cohort 2 PF-05251749: 10 mg + 100 mg + 500 mg + Placebo|Participants received a single oral dose of PF-05251749 suspension on Day 1 of each Intervention Period (4 Intervention Periods of 3 days each). Participants received study treatment in following sequences: PF-05251749 10 mg, PF-05251749 100 mg, PF-05251749 500 mg, PF-05251749 placebo in Intervention Period 1, 2, 3 and 4 respectively. All doses were administered in fasted state. A washout period of at least 7 days was maintained between each Intervention Period.
30464|NCT02443740|P7|Participant Flow|Cohort 2 PF-05251749: 10 mg + 100 mg + Placebo + 1000 mg|Participants received a single oral dose of PF-05251749 suspension on Day 1 of each Intervention Period (4 Intervention Periods of 3 days each). Participants received study treatment in following sequences: PF-05251749 10 mg, PF-05251749 100 mg, PF-05251749 placebo, PF-05251749 1000 mg in Intervention Period 1, 2, 3 and 4 respectively. All doses were administered in fasted state. A washout period of at least 7 days was maintained between each Intervention Period.
30465|NCT02443740|P6|Participant Flow|Cohort 2 PF-05251749: 10 mg + Placebo + 500 mg + 1000 mg|Participants received a single oral dose of PF-05251749 suspension on Day 1 of each Intervention Period (4 Intervention Periods of 3 days each). Participants received study treatment in following sequences: PF-05251749 10 mg, PF-05251749 placebo, PF-05251749 500 mg, PF-05251749 1000 mg in Intervention Period 1, 2, 3 and 4 respectively. All doses were administered in fasted state. A washout period of at least 7 days was maintained between each Intervention Period.
30466|NCT02443740|P5|Participant Flow|Cohort 2 PF-05251749: Placebo + 100 mg + 500 mg + 1000 mg|Participants received a single oral dose of PF-05251749 suspension on Day 1 of each Intervention Period (4 Intervention Periods of 3 days each). Participants received study treatment in following sequences: PF-05251749 placebo, PF-05251749 100 mg, PF-05251749 500 mg, PF-05251749 1000 mg in Intervention Period 1, 2, 3 and 4 respectively. All doses were administered in fasted state. A washout period of at least 7 days was maintained between each Intervention Period.
30467|NCT02443740|P4|Participant Flow|Cohort 1 PF-05251749: 3 mg + 30 mg + 250 mg + Placebo|Participants received a single oral dose of PF-05251749 suspension on Day 1 of each Intervention Period (4 Intervention Periods of 3 days each). Participants received study treatment in following sequences: PF-05251749 3 mg, 30 mg, 250 mg and placebo in Intervention Period 1, 2, 3 and 4 respectively. All doses were administered in fasted state except PF-05251749 500 mg. A washout period of at least 7 days was maintained between each Intervention Period.
30468|NCT02443740|P3|Participant Flow|Cohort 1 PF-05251749: 3 mg + 30 mg + Placebo + 500 mg|Participants received a single oral dose of PF-05251749 suspension on Day 1 of each Intervention Period (4 Intervention Periods of 3 days each). Participants received study treatment in following sequences: PF-05251749 3 mg, 30 mg, placebo and PF-05251749 500 mg in Intervention Period 1, 2, 3 and 4 respectively. All doses were administered in fasted state except PF-05251749 500 mg. A washout period of at least 7 days was maintained between each Intervention Period.
30469|NCT02443740|P2|Participant Flow|Cohort 1 PF-05251749: 3 mg + Placebo + 250 mg + 500 mg|Participants received a single oral dose of PF-05251749 suspension on Day 1 of each Intervention Period (4 Intervention Periods of 3 days each). Participants received study treatment in following sequences: PF-05251749 3 mg, placebo, PF-05251749 250 mg and 500 mg in Intervention Period 1, 2, 3 and 4 respectively. All doses were administered in fasted state except PF-05251749 500 mg. A washout period of at least 7 days was maintained between each Intervention Period.
30470|NCT02443740|P1|Participant Flow|Cohort 1 PF-05251749: Placebo + 30 mg + 250 mg + 500 mg|Participants received a single oral dose of PF-05251749 suspension on Day 1 of each Intervention Period (4 Intervention Periods of 3 days each). Participants received study treatment in following sequences: Placebo, PF-05251749 30 milligram (mg), 250 mg and 500 mg in Intervention Period 1, 2, 3 and 4 respectively. All doses were administered in fasted state except PF-05251749 500 mg. A washout period of at least 7 days was maintained between each Intervention Period.
30471|NCT02443740|O2|Outcome|Cohort 3: PF-05251749 500 mg CSF|Participants received a single oral suspension of PF-05251749 500 mg on Day 1.
30472|NCT02443740|O1|Outcome|Cohort 3: PF-05251749 500 mg (Plasma CSF Concentration)|Participants received a single oral suspension of PF-05251749 500 mg on Day 1. CSF samples were collected for a total of 10 hours beginning 2 hours predose and 8 hours post dose.
30473|NCT02443740|O2|Outcome|Cohort 3: PF-05251749 500 mg CSF|Participants received a single oral suspension of PF-05251749 500 mg on Day 1.
30474|NCT02443740|O1|Outcome|Cohort 3: PF-05251749 500 mg (Plasma CSF Concentration)|Participants received a single oral suspension of PF-05251749 500 mg on Day 1. CSF samples were collected for a total of 10 hours beginning 2 hours predose and 8 hours post dose.
30475|NCT02443740|O2|Outcome|Cohort 3: PF-05251749 500 mg CSF|Participants received a single oral suspension of PF-05251749 500 mg on Day 1.
30476|NCT02443740|O1|Outcome|Cohort 3: PF-05251749 500 mg (Plasma CSF Concentration)|Participants received a single oral suspension of PF-05251749 500 mg on Day 1. CSF samples were collected for a total of 10 hours beginning 2 hours predose and 8 hours post dose.
30477|NCT02443740|O2|Outcome|Cohort 3: PF-05251749 500 mg CSF|Participants received a single oral suspension of PF-05251749 500 mg on Day 1.
30478|NCT02443740|O1|Outcome|Cohort 3: PF-05251749 500 mg (Plasma CSF Concentration)|Participants received a single oral suspension of PF-05251749 500 mg on Day 1. CSF samples were collected for a total of 10 hours beginning 2 hours predose and 8 hours post dose.
30479|NCT02443740|O2|Outcome|Cohort 4: PF-05251749 500 mg Milled|Participants received a single oral dose of PF-05251749 10 mg oral suspension (milled) on Day 1 of Intervention Period in Cohort 4.
30480|NCT02443740|O1|Outcome|Cohort 4: PF-05251749 500 mg Unmilled|Participants received a single oral dose of PF-05251749 10 mg oral suspension (unmilled) on Day 1 of Intervention Period in Cohort 4.
30481|NCT02443740|O2|Outcome|Cohort 4: PF-05251749 500 mg Milled|Participants received a single oral dose of PF-05251749 10 mg oral suspension (milled) on Day 1 of Intervention Period in Cohort 4.
30482|NCT02443740|O1|Outcome|Cohort 4: PF-05251749 500 mg Unmilled|Participants received a single oral dose of PF-05251749 10 mg oral suspension (unmilled) on Day 1 of Intervention Period in Cohort 4.
30483|NCT02443740|O2|Outcome|Cohort 4: PF-05251749 500 mg Milled|Participants received a single oral dose of PF-05251749 10 mg oral suspension (milled) on Day 1 of Intervention Period in Cohort 4.
30484|NCT02443740|O1|Outcome|Cohort 4: PF-05251749 500 mg Unmilled|Participants received a single oral dose of PF-05251749 10 mg oral suspension (unmilled) on Day 1 of Intervention Period in Cohort 4.
30485|NCT02443740|O2|Outcome|Cohort 4: PF-05251749 500 mg Milled|Participants received a single oral dose of PF-05251749 10 mg oral suspension (milled) on Day 1 of Intervention Period in Cohort 4.
30486|NCT02443740|O1|Outcome|Cohort 4: PF-05251749 500 mg Unmilled|Participants received a single oral dose of PF-05251749 10 mg oral suspension (unmilled) on Day 1 of Intervention Period in Cohort 4.
30487|NCT02443740|O8|Outcome|Cohort 2: PF-05251749 1000 mg|Participants received a single oral dose of PF-05251749 1000 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30488|NCT02443740|O7|Outcome|Cohort 2: PF-05251749 500 mg|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30489|NCT02443740|O6|Outcome|Cohort 2: PF-05251749 100 mg|Participants received a single oral dose of PF-05251749 100 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30490|NCT02443740|O5|Outcome|Cohort 2: PF-05251749 10 mg|Participants received a single oral dose of PF-05251749 10 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30491|NCT02443740|O4|Outcome|Cohort 1: PF-05251749 500 mg (FED)|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30492|NCT02443740|O3|Outcome|Cohort 1: PF-05251749 250 mg|Participants received a single oral dose of PF-05251749 250 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30493|NCT02443740|O2|Outcome|Cohort 1: PF-05251749 30 mg|Participants received a single oral dose of PF-05251749 30 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30494|NCT02443740|O1|Outcome|Cohort 1: PF-05251749 3 mg|Participants received a single oral dose of PF-05251749 3 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30495|NCT02443740|O8|Outcome|Cohort 2: PF-05251749 1000 mg|Participants received a single oral dose of PF-05251749 1000 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30496|NCT02443740|O7|Outcome|Cohort 2: PF-05251749 500 mg|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30497|NCT02443740|O6|Outcome|Cohort 2: PF-05251749 100 mg|Participants received a single oral dose of PF-05251749 100 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30498|NCT02443740|O5|Outcome|Cohort 2: PF-05251749 10 mg|Participants received a single oral dose of PF-05251749 10 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30499|NCT02443740|O4|Outcome|Cohort 1: PF-05251749 500 mg (FED)|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30500|NCT02443740|O3|Outcome|Cohort 1: PF-05251749 250 mg|Participants received a single oral dose of PF-05251749 250 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30501|NCT02443740|O2|Outcome|Cohort 1: PF-05251749 30 mg|Participants received a single oral dose of PF-05251749 30 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30502|NCT02443740|O1|Outcome|Cohort 1: PF-05251749 3 mg|Participants received a single oral dose of PF-05251749 3 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30503|NCT02443740|O8|Outcome|Cohort 2: PF-05251749 1000 mg|Participants received a single oral dose of PF-05251749 1000 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30504|NCT02443740|O7|Outcome|Cohort 2: PF-05251749 500 mg|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30505|NCT02443740|O6|Outcome|Cohort 2: PF-05251749 100 mg|Participants received a single oral dose of PF-05251749 100 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30506|NCT02443740|O5|Outcome|Cohort 2: PF-05251749 10 mg|Participants received a single oral dose of PF-05251749 10 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30507|NCT02443740|O4|Outcome|Cohort 1: PF-05251749 500 mg (FED)|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30508|NCT02443740|O3|Outcome|Cohort 1: PF-05251749 250 mg|Participants received a single oral dose of PF-05251749 250 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30509|NCT02443740|O2|Outcome|Cohort 1: PF-05251749 30 mg|Participants received a single oral dose of PF-05251749 30 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30510|NCT02443740|O1|Outcome|Cohort 1: PF-05251749 3 mg|Participants received a single oral dose of PF-05251749 3 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30511|NCT02443740|O8|Outcome|Cohort 2: PF-05251749 1000 mg|Participants received a single oral dose of PF-05251749 1000 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30512|NCT02443740|O7|Outcome|Cohort 2: PF-05251749 500 mg|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30513|NCT02443740|O6|Outcome|Cohort 2: PF-05251749 100 mg|Participants received a single oral dose of PF-05251749 100 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30514|NCT02443740|O5|Outcome|Cohort 2: PF-05251749 10 mg|Participants received a single oral dose of PF-05251749 10 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30515|NCT02443740|O4|Outcome|Cohort 1: PF-05251749 500 mg (FED)|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30516|NCT02443740|O3|Outcome|Cohort 1: PF-05251749 250 mg|Participants received a single oral dose of PF-05251749 250 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30517|NCT02443740|O2|Outcome|Cohort 1: PF-05251749 30 mg|Participants received a single oral dose of PF-05251749 30 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30518|NCT02443740|O1|Outcome|Cohort 1: PF-05251749 3 mg|Participants received a single oral dose of PF-05251749 3 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30519|NCT02443740|O8|Outcome|Cohort 2: PF-05251749 1000 mg|Participants received a single oral dose of PF-05251749 1000 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30520|NCT02443740|O7|Outcome|Cohort 2: PF-05251749 500 mg|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30521|NCT02443740|O6|Outcome|Cohort 2: PF-05251749 100 mg|Participants received a single oral dose of PF-05251749 100 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30522|NCT02443740|O5|Outcome|Cohort 2: PF-05251749 10 mg|Participants received a single oral dose of PF-05251749 10 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30523|NCT02443740|O4|Outcome|Cohort 1: PF-05251749 500 mg (FED)|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30524|NCT02443740|O3|Outcome|Cohort 1: PF-05251749 250 mg|Participants received a single oral dose of PF-05251749 250 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30525|NCT02443740|O2|Outcome|Cohort 1: PF-05251749 30 mg|Participants received a single oral dose of PF-05251749 30 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30526|NCT02443740|O1|Outcome|Cohort 1: PF-05251749 3 mg|Participants received a single oral dose of PF-05251749 3 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30527|NCT02443740|O8|Outcome|Cohort 2: PF-05251749 1000 mg|Participants received a single oral dose of PF-05251749 1000 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30528|NCT02443740|O7|Outcome|Cohort 2: PF-05251749 500 mg|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30529|NCT02443740|O6|Outcome|Cohort 2: PF-05251749 100 mg|Participants received a single oral dose of PF-05251749 100 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30530|NCT02443740|O5|Outcome|Cohort 2: PF-05251749 10 mg|Participants received a single oral dose of PF-05251749 10 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30531|NCT02443740|O4|Outcome|Cohort 1: PF-05251749 500 mg (FED)|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30532|NCT02443740|O3|Outcome|Cohort 1: PF-05251749 250 mg|Participants received a single oral dose of PF-05251749 250 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30533|NCT02443740|O2|Outcome|Cohort 1: PF-05251749 30 mg|Participants received a single oral dose of PF-05251749 30 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30534|NCT02443740|O1|Outcome|Cohort 1: PF-05251749 3 mg|Participants received a single oral dose of PF-05251749 3 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30535|NCT02443740|O8|Outcome|Cohort 2: PF-05251749 1000 mg|Participants received a single oral dose of PF-05251749 1000 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30536|NCT02443740|O7|Outcome|Cohort 2: PF-05251749 500 mg|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30537|NCT02443740|O6|Outcome|Cohort 2: PF-05251749 100 mg|Participants received a single oral dose of PF-05251749 100 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30538|NCT02443740|O5|Outcome|Cohort 2: PF-05251749 10 mg|Participants received a single oral dose of PF-05251749 10 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30539|NCT02443740|O4|Outcome|Cohort 1: PF-05251749 500 mg (FED)|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30540|NCT02443740|O3|Outcome|Cohort 1: PF-05251749 250 mg|Participants received a single oral dose of PF-05251749 250 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30541|NCT02443740|O2|Outcome|Cohort 1: PF-05251749 30 mg|Participants received a single oral dose of PF-05251749 30 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30542|NCT02443740|O1|Outcome|Cohort 1: PF-05251749 3 mg|Participants received a single oral dose of PF-05251749 3 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30543|NCT02443740|O9|Outcome|Cohort 1-2: Placebo|Participants received a single oral dose of placebo matching to PF-05251749 oral suspension on Day 1 of Intervention Period in Cohort 1 and 2.
30544|NCT02443740|O8|Outcome|Cohort 2: PF-05251749 1000 mg|Participants received a single oral dose of PF-05251749 1000 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30545|NCT02443740|O7|Outcome|Cohort 2: PF-05251749 500 mg|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30546|NCT02443740|O6|Outcome|Cohort 2: PF-05251749 100 mg|Participants received a single oral dose of PF-05251749 100 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30547|NCT02443740|O5|Outcome|Cohort 2: PF-05251749 10 mg|Participants received a single oral dose of PF-05251749 10 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30548|NCT02443740|O4|Outcome|Cohort 1: PF-05251749 500 mg (FED)|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30549|NCT02443740|O3|Outcome|Cohort 1: PF-05251749 250 mg|Participants received a single oral dose of PF-05251749 250 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30550|NCT02443740|O2|Outcome|Cohort 1: PF-05251749 30 mg|Participants received a single oral dose of PF-05251749 30 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30551|NCT02443740|O1|Outcome|Cohort 1: PF-05251749 3 mg|Participants received a single oral dose of PF-05251749 3 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30552|NCT02443740|O9|Outcome|Cohort 1-2: Placebo|Participants received a single oral dose of placebo matching to PF-05251749 oral suspension on Day 1 of Intervention Period in Cohort 1 and 2.
30553|NCT02443740|O8|Outcome|Cohort 2: PF-05251749 1000 mg|Participants received a single oral dose of PF-05251749 1000 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30554|NCT02443740|O7|Outcome|Cohort 2: PF-05251749 500 mg|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30555|NCT02443740|O6|Outcome|Cohort 2: PF-05251749 100 mg|Participants received a single oral dose of PF-05251749 100 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30556|NCT02443740|O5|Outcome|Cohort 2: PF-05251749 10 mg|Participants received a single oral dose of PF-05251749 10 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30557|NCT02443740|O4|Outcome|Cohort 1: PF-05251749 500 mg (FED)|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30558|NCT02443740|O3|Outcome|Cohort 1: PF-05251749 250 mg|Participants received a single oral dose of PF-05251749 250 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30559|NCT02443740|O2|Outcome|Cohort 1: PF-05251749 30 mg|Participants received a single oral dose of PF-05251749 30 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30560|NCT02443740|O1|Outcome|Cohort 1: PF-05251749 3 mg|Participants received a single oral dose of PF-05251749 3 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30561|NCT02443740|O9|Outcome|Cohort 1-2: Placebo|Participants received a single oral dose of placebo matching to PF-05251749 oral suspension on Day 1 of Intervention Period in Cohort 1 and 2.
30562|NCT02443740|O8|Outcome|Cohort 2: PF-05251749 1000 mg|Participants received a single oral dose of PF-05251749 1000 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30563|NCT02443740|O7|Outcome|Cohort 2: PF-05251749 500 mg|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30564|NCT02443740|O6|Outcome|Cohort 2: PF-05251749 100 mg|Participants received a single oral dose of PF-05251749 100 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30565|NCT02443740|O5|Outcome|Cohort 2: PF-05251749 10 mg|Participants received a single oral dose of PF-05251749 10 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30566|NCT02443740|O4|Outcome|Cohort 1: PF-05251749 500 mg (FED)|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30567|NCT02443740|O3|Outcome|Cohort 1: PF-05251749 250 mg|Participants received a single oral dose of PF-05251749 250 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30568|NCT02443740|O2|Outcome|Cohort 1: PF-05251749 30 mg|Participants received a single oral dose of PF-05251749 30 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30569|NCT02443740|O1|Outcome|Cohort 1: PF-05251749 3 mg|Participants received a single oral dose of PF-05251749 3 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30570|NCT02443740|O9|Outcome|Cohort 1-2: Placebo|Participants received a single oral dose of placebo matching to PF-05251749 oral suspension on Day 1 of Intervention Period in Cohort 1 and 2.
30571|NCT02443740|O8|Outcome|Cohort 2: PF-05251749 1000 mg|Participants received a single oral dose of PF-05251749 1000 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30572|NCT02443740|O7|Outcome|Cohort 2: PF-05251749 500 mg|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30573|NCT02443740|O6|Outcome|Cohort 2: PF-05251749 100 mg|Participants received a single oral dose of PF-05251749 100 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30574|NCT02443740|O5|Outcome|Cohort 2: PF-05251749 10 mg|Participants received a single oral dose of PF-05251749 10 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30575|NCT02443740|O4|Outcome|Cohort 1: PF-05251749 500 mg (FED)|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30576|NCT02443740|O3|Outcome|Cohort 1: PF-05251749 250 mg|Participants received a single oral dose of PF-05251749 250 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30577|NCT02443740|O2|Outcome|Cohort 1: PF-05251749 30 mg|Participants received a single oral dose of PF-05251749 30 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30578|NCT02443740|O1|Outcome|Cohort 1: PF-05251749 3 mg|Participants received a single oral dose of PF-05251749 3 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30579|NCT02443740|O9|Outcome|Cohort 1-2: Placebo|Participants received a single oral dose of placebo matching to PF-05251749 oral suspension on Day 1 of Intervention Period in Cohort 1 and 2.
30580|NCT02443740|O8|Outcome|Cohort 2: PF-05251749 1000 mg|Participants received a single oral dose of PF-05251749 1000 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30581|NCT02443740|O7|Outcome|Cohort 2: PF-05251749 500 mg|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30582|NCT02443740|O6|Outcome|Cohort 2: PF-05251749 100 mg|Participants received a single oral dose of PF-05251749 100 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30583|NCT02443740|O5|Outcome|Cohort 2: PF-05251749 10 mg|Participants received a single oral dose of PF-05251749 10 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30584|NCT02443740|O4|Outcome|Cohort 1: PF-05251749 500 mg (FED)|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30585|NCT02443740|O3|Outcome|Cohort 1: PF-05251749 250 mg|Participants received a single oral dose of PF-05251749 250 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30586|NCT02443740|O2|Outcome|Cohort 1: PF-05251749 30 mg|Participants received a single oral dose of PF-05251749 30 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30587|NCT02443740|O1|Outcome|Cohort 1: PF-05251749 3 mg|Participants received a single oral dose of PF-05251749 3 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30588|NCT02443740|O12|Outcome|Cohort 4: PF-05251749 500 mg Milled|Participants received a single oral dose of PF-05251749 10 mg oral suspension (milled) on Day 1 of Intervention Period in Cohort 4.
30589|NCT02443740|O11|Outcome|Cohort 4: PF-05251749 500 mg Unmilled|Participants received a single oral dose of PF-05251749 10 mg oral suspension (unmilled) on Day 1 of Intervention Period in Cohort 4.
30590|NCT02443740|O10|Outcome|Cohort 3: PF-05251749 500 mg CSF|Participants received a single oral suspension of PF-05251749 500 mg on Day 1. CSF samples were collected for a total of 10 hours beginning 2 hours predose and 8 hours post dose.
30591|NCT02443740|O9|Outcome|Cohort 1-2: Placebo|Participants received a single oral dose of placebo matching to PF-05251749 oral suspension on Day 1 of Intervention Period in Cohort 1 and 2.
30592|NCT02443740|O8|Outcome|Cohort 2: PF-05251749 1000 mg|Participants received a single oral dose of PF-05251749 1000 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30593|NCT02443740|O7|Outcome|Cohort 2: PF-05251749 500 mg|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30594|NCT02443740|O6|Outcome|Cohort 2: PF-05251749 100 mg|Participants received a single oral dose of PF-05251749 100 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30595|NCT02443740|O5|Outcome|Cohort 2: PF-05251749 10 mg|Participants received a single oral dose of PF-05251749 10 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30596|NCT02443740|O4|Outcome|Cohort 1: PF-05251749 500 mg (FED)|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30760|NCT02442349|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
30597|NCT02443740|O3|Outcome|Cohort 1: PF-05251749 250 mg|Participants received a single oral dose of PF-05251749 250 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30598|NCT02443740|O2|Outcome|Cohort 1: PF-05251749 30 mg|Participants received a single oral dose of PF-05251749 30 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30599|NCT02443740|O1|Outcome|Cohort 1: PF-05251749 3 mg|Participants received a single oral dose of PF-05251749 3 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30600|NCT02443740|O12|Outcome|Cohort 4: PF-05251749 500 mg Milled|Participants received a single oral dose of PF-05251749 10 mg oral suspension (milled) on Day 1 of Intervention Period in Cohort 4.
30601|NCT02443740|O11|Outcome|Cohort 4: PF-05251749 500 mg Unmilled|Participants received a single oral dose of PF-05251749 10 mg oral suspension (unmilled) on Day 1 of Intervention Period in Cohort 4.
30602|NCT02443740|O10|Outcome|Cohort 3: PF-05251749 500 mg CSF|Participants received a single oral suspension of PF-05251749 500 mg on Day 1. CSF samples were collected for a total of 10 hours beginning 2 hours predose and 8 hours post dose.
30603|NCT02443740|O9|Outcome|Cohort 1-2: Placebo|Participants received a single oral dose of placebo matching to PF-05251749 oral suspension on Day 1 of Intervention Period in Cohort 1 and 2.
30604|NCT02443740|O8|Outcome|Cohort 2: PF-05251749 1000 mg|Participants received a single oral dose of PF-05251749 1000 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30605|NCT02443740|O7|Outcome|Cohort 2: PF-05251749 500 mg|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30606|NCT02443740|O6|Outcome|Cohort 2: PF-05251749 100 mg|Participants received a single oral dose of PF-05251749 100 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30607|NCT02443740|O5|Outcome|Cohort 2: PF-05251749 10 mg|Participants received a single oral dose of PF-05251749 10 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30608|NCT02443740|O4|Outcome|Cohort 1: PF-05251749 500 mg (FED)|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30609|NCT02443740|O3|Outcome|Cohort 1: PF-05251749 250 mg|Participants received a single oral dose of PF-05251749 250 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30610|NCT02443740|O2|Outcome|Cohort 1: PF-05251749 30 mg|Participants received a single oral dose of PF-05251749 30 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30611|NCT02443740|O1|Outcome|Cohort 1: PF-05251749 3 mg|Participants received a single oral dose of PF-05251749 3 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30612|NCT02443740|O12|Outcome|Cohort 4: PF-05251749 500 mg Milled|Participants received a single oral dose of PF-05251749 10 mg oral suspension (milled) on Day 1 of Intervention Period in Cohort 4.
30613|NCT02443740|O11|Outcome|Cohort 4: PF-05251749 500 mg Unmilled|Participants received a single oral dose of PF-05251749 10 mg oral suspension (unmilled) on Day 1 of Intervention Period in Cohort 4.
30614|NCT02443740|O10|Outcome|Cohort 3: PF-05251749 500 mg CSF|Participants received a single oral suspension of PF-05251749 500 mg on Day 1. CSF samples were collected for a total of 10 hours beginning 2 hours predose and 8 hours post dose.
30615|NCT02443740|O9|Outcome|Cohort 1-2: Placebo|Participants received a single oral dose of placebo matching to PF-05251749 oral suspension on Day 1 of Intervention Period in Cohort 1 and 2.
30616|NCT02443740|O8|Outcome|Cohort 2: PF-05251749 1000 mg|Participants received a single oral dose of PF-05251749 1000 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30617|NCT02443740|O7|Outcome|Cohort 2: PF-05251749 500 mg|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30618|NCT02443740|O6|Outcome|Cohort 2: PF-05251749 100 mg|Participants received a single oral dose of PF-05251749 100 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30619|NCT02443740|O5|Outcome|Cohort 2: PF-05251749 10 mg|Participants received a single oral dose of PF-05251749 10 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30620|NCT02443740|O4|Outcome|Cohort 1: PF-05251749 500 mg (FED)|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30621|NCT02443740|O3|Outcome|Cohort 1: PF-05251749 250 mg|Participants received a single oral dose of PF-05251749 250 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30622|NCT02443740|O2|Outcome|Cohort 1: PF-05251749 30 mg|Participants received a single oral dose of PF-05251749 30 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30623|NCT02443740|O1|Outcome|Cohort 1: PF-05251749 3 mg|Participants received a single oral dose of PF-05251749 3 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30624|NCT02443740|O12|Outcome|Cohort 4: PF-05251749 500 mg Milled|Participants received a single oral dose of PF-05251749 10 mg oral suspension (milled) on Day 1 of Intervention Period in Cohort 4.
30625|NCT02443740|O11|Outcome|Cohort 4: PF-05251749 500 mg Unmilled|Participants received a single oral dose of PF-05251749 10 mg oral suspension (unmilled) on Day 1 of Intervention Period in Cohort 4.
30626|NCT02443740|O10|Outcome|Cohort 3: PF-05251749 500 mg CSF|Participants received a single oral suspension of PF-05251749 500 mg on Day 1. CSF samples were collected for a total of 10 hours beginning 2 hours predose and 8 hours post dose.
30627|NCT02443740|O9|Outcome|Cohort 1-2: Placebo|Participants received a single oral dose of placebo matching to PF-05251749 oral suspension on Day 1 of Intervention Period in Cohort 1 and 2.
30628|NCT02443740|O8|Outcome|Cohort 2: PF-05251749 1000 mg|Participants received a single oral dose of PF-05251749 1000 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30629|NCT02443740|O7|Outcome|Cohort 2: PF-05251749 500 mg|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30630|NCT02443740|O6|Outcome|Cohort 2: PF-05251749 100 mg|Participants received a single oral dose of PF-05251749 100 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30631|NCT02443740|O5|Outcome|Cohort 2: PF-05251749 10 mg|Participants received a single oral dose of PF-05251749 10 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30632|NCT02443740|O4|Outcome|Cohort 1: PF-05251749 500 mg (FED)|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30761|NCT02442349|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
30633|NCT02443740|O3|Outcome|Cohort 1: PF-05251749 250 mg|Participants received a single oral dose of PF-05251749 250 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30634|NCT02443740|O2|Outcome|Cohort 1: PF-05251749 30 mg|Participants received a single oral dose of PF-05251749 30 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30635|NCT02443740|O1|Outcome|Cohort 1: PF-05251749 3 mg|Participants received a single oral dose of PF-05251749 3 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30636|NCT02443740|E12|Reported Event|Cohort 4: PF-05251749 500 mg Milled|Participants received a single oral dose of PF-05251749 10 mg oral suspension (milled) on Day 1 of Intervention Period in Cohort 4.
30637|NCT02443740|E11|Reported Event|Cohort 4: PF-05251749 500 mg Unmilled|Participants received a single oral dose of PF-05251749 10 mg oral suspension (unmilled) on Day 1 of Intervention Period in Cohort 4.
30638|NCT02443740|E10|Reported Event|Cohort 3: PF-05251749 500 mg CSF|Participants received a single oral suspension of PF-05251749 500 mg on Day 1. CSF samples were collected for a total of 10 hours beginning 2 hours predose and 8 hours post dose.
30639|NCT02443740|E9|Reported Event|Cohort 1-2: Placebo|Participants received a single oral dose of placebo matching to PF-05251749 oral suspension on Day 1 of Intervention Period in Cohort 1 and 2.
30640|NCT02443740|E8|Reported Event|Cohort 2: PF-05251749 1000 mg|Participants received a single oral dose of PF-05251749 1000 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30641|NCT02443740|E7|Reported Event|Cohort 2: PF-05251749 500 mg|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30642|NCT02443740|E6|Reported Event|Cohort 2: PF-05251749 100 mg|Participants received a single oral dose of PF-05251749 100 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30643|NCT02443740|E5|Reported Event|Cohort 2: PF-05251749 10 mg|Participants received a single oral dose of PF-05251749 10 mg oral suspension on Day 1 of Intervention Period in Cohort 2.
30644|NCT02443740|E4|Reported Event|Cohort 1: PF-05251749 500 mg (FED)|Participants received a single oral dose of PF-05251749 500 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30645|NCT02443740|E3|Reported Event|Cohort 1: PF-05251749 250 mg|Participants received a single oral dose of PF-05251749 250 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30646|NCT02443740|E2|Reported Event|Cohort 1: PF-05251749 30 mg|Participants received a single oral dose of PF-05251749 30 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30647|NCT02443740|E1|Reported Event|Cohort 1: PF-05251749 3 mg|Participants received a single oral dose of PF-05251749 3 mg oral suspension on Day 1 of Intervention Period in Cohort 1.
30648|NCT02443402|B3|Baseline|Total|Total of all reporting groups
30649|NCT02443402|B2|Baseline|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30650|NCT02443402|B1|Baseline|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30651|NCT02443402|P2|Participant Flow|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30652|NCT02443402|P1|Participant Flow|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30653|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30654|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30655|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30656|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30657|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30658|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30659|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30660|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30661|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30662|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30663|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30664|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30665|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30666|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30667|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30668|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30669|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30670|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30671|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30672|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30673|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30674|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30675|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30676|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30677|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30678|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30679|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30680|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30681|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30682|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30683|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30684|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30685|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30686|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30687|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30688|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30689|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30690|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30691|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30692|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30693|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30694|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30695|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30696|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30697|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30698|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30699|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30700|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30701|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30702|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30703|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30704|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30705|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30706|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30707|NCT02443402|O2|Outcome|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30708|NCT02443402|O1|Outcome|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30709|NCT02443402|E2|Reported Event|Placebo|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
30710|NCT02443402|E1|Reported Event|Sitagliptin|Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
30711|NCT02443103|B1|Baseline|Guanabenz|Guanabenz (titrate up from 8mg PO QPM to 16mg PO BID max dose)
30712|NCT02443103|P1|Participant Flow|Guanabenz|Guanabenz (titrate up from 8mg PO QPM to 16mg PO BID max dose)
30713|NCT02443103|O1|Outcome|Guanabenz|Guanabenz (titrate up from 8mg PO QPM to 16mg PO BID max dose)
30714|NCT02443103|O1|Outcome|Guanabenz|Guanabenz (titrate up from 8mg PO QPM to 16mg PO BID max dose)
30715|NCT02443103|E1|Reported Event|Guanabenz|Guanabenz (titrate up from 8mg PO QPM to 16mg PO BID max dose)
30716|NCT02442804|B3|Baseline|Total|Total of all reporting groups
30717|NCT02442804|B2|Baseline|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
30718|NCT02442804|B1|Baseline|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
30719|NCT02442804|P2|Participant Flow|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
30720|NCT02442804|P1|Participant Flow|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
30721|NCT02442804|O2|Outcome|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
30722|NCT02442804|O1|Outcome|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
30723|NCT02442804|O2|Outcome|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
30724|NCT02442804|O1|Outcome|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
30725|NCT02442804|O2|Outcome|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
30726|NCT02442804|O1|Outcome|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
30727|NCT02442804|O2|Outcome|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
30728|NCT02442804|O1|Outcome|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
30729|NCT02442804|O2|Outcome|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
30730|NCT02442804|O1|Outcome|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
30731|NCT02442804|O2|Outcome|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
30732|NCT02442804|O1|Outcome|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
30733|NCT02442804|O2|Outcome|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
30734|NCT02442804|O1|Outcome|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
30735|NCT02442804|O2|Outcome|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
30736|NCT02442804|O1|Outcome|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
30737|NCT02442804|O2|Outcome|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
30738|NCT02442804|O1|Outcome|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
30739|NCT02442804|O2|Outcome|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
30740|NCT02442804|O1|Outcome|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
30741|NCT02442804|O2|Outcome|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
30742|NCT02442804|O1|Outcome|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
30743|NCT02442804|O2|Outcome|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
30744|NCT02442804|O1|Outcome|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
30745|NCT02442804|E2|Reported Event|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
30746|NCT02442804|E1|Reported Event|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
30747|NCT02442700|B3|Baseline|Total|Total of all reporting groups
30748|NCT02442700|B2|Baseline|Treatment B, A|Treatment visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
30749|NCT02442700|B1|Baseline|Treatment A, B|Treatment visits were separated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks
30750|NCT02442700|P2|Participant Flow|Treatment B, A|Treatment visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
30751|NCT02442700|P1|Participant Flow|Treatment A, B|Treatment visits were separated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks
30752|NCT02442700|O2|Outcome|Treatment B|Treatment visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
30753|NCT02442700|O1|Outcome|Treatment A|Treatment visits were separated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks
30754|NCT02442700|O2|Outcome|Treatment B|Treatment visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
30755|NCT02442700|O1|Outcome|Treatment A|Treatment visits were separated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks
30756|NCT02442700|E2|Reported Event|Treatment B|Treatment B = administration placebo for 12 weeks
30757|NCT02442700|E1|Reported Event|Treatment A|Treatment A = administration pitavastatin for 12 weeks
30758|NCT02442349|B1|Baseline|AZD9291 80mg|Daily single dose of AZD9291 80mg
30763|NCT02442310|B1|Baseline|Healthy Volunteers|"Subjects were randomized to receive the following four treatments in different orders, with a 7-day washout period between treatments:~Deferiprone delayed release tablets under fed conditions.~Deferiprone delayed release tablets under fasting conditions.~Deferiprone delayed release tablets administered as half-tablets, under fed conditions.~Deferiprone oral solution under fasting conditions"
30764|NCT02442310|P1|Participant Flow|Healthy Volunteers|"Subjects were randomized to receive the following four treatments in different orders, with a 7-day washout period between treatments:~Deferiprone delayed release tablets under fed conditions.~Deferiprone delayed release tablets under fasting conditions.~Deferiprone delayed release tablets administered as half-tablets, under fed conditions.~Deferiprone oral solution under fasting conditions"
30765|NCT02442310|O4|Outcome|Oral Solution, Fasting Conditions|"A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast~Deferiprone oral solution: Deferiprone 100 mg/mL oral solution"
30766|NCT02442310|O3|Outcome|Delayed Release Half-tablets|"A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
30767|NCT02442310|O2|Outcome|Delayed Release, Fasting Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
30768|NCT02442310|O1|Outcome|Delayed Release, Fed Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
30769|NCT02442310|O4|Outcome|Oral Solution, Fasting Conditions|"A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast~Deferiprone oral solution: Deferiprone 100 mg/mL oral solution"
30770|NCT02442310|O3|Outcome|Delayed Release Half-tablets|"A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
30771|NCT02442310|O2|Outcome|Delayed Release, Fasting Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
30772|NCT02442310|O1|Outcome|Delayed Release, Fed Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
30773|NCT02442310|O4|Outcome|Oral Solution, Fasting Conditions|"A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast~Deferiprone oral solution: Deferiprone 100 mg/mL oral solution"
30774|NCT02442310|O3|Outcome|Delayed Release Half-tablets|"A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
30775|NCT02442310|O2|Outcome|Delayed Release, Fasting Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
30776|NCT02442310|O1|Outcome|Delayed Release, Fed Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
30777|NCT02442310|O4|Outcome|Oral Solution, Fasting Conditions|"A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast~Deferiprone oral solution: Deferiprone 100 mg/mL oral solution"
30778|NCT02442310|O3|Outcome|Delayed Release Half-tablets|"A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
30779|NCT02442310|O2|Outcome|Delayed Release, Fasting Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
30780|NCT02442310|O1|Outcome|Delayed Release, Fed Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
30781|NCT02442310|E4|Reported Event|Oral Solution, Fasting Conditions|"A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast~Deferiprone oral solution: Deferiprone 100 mg/mL oral solution"
30782|NCT02442310|E3|Reported Event|Delayed Release Half-tablets|"A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
30783|NCT02442310|E2|Reported Event|Delayed Release, Fasting Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
30784|NCT02442310|E1|Reported Event|Delayed Release, Fed Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
30785|NCT02442284|B1|Baseline|3-DAA ± RBV for 12 or 24 Weeks|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
30786|NCT02442284|P1|Participant Flow|3-DAA ± RBV for 12 or 24 Weeks|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
30787|NCT02442284|O1|Outcome|3-DAA ± RBV for 12 or 24 Weeks|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
31346|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
30788|NCT02442284|O1|Outcome|3-DAA ± RBV for 12 or 24 Weeks|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
30789|NCT02442284|O1|Outcome|3-DAA ± RBV for 12 or 24 Weeks|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
30790|NCT02442284|O1|Outcome|3-DAA ± RBV for 12 or 24 Weeks|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
30791|NCT02442284|E1|Reported Event|3-DAA ± RBV for 12 or 24 Weeks|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
30792|NCT02442271|B1|Baseline|3-DAA ± RBV|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
30793|NCT02442271|P1|Participant Flow|3-DAA ± RBV|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
30794|NCT02442271|O2|Outcome|Fibrosis Stage F4|Participants with baseline fibrosis stage F4 (with compensated cirrhosis).
30795|NCT02442271|O1|Outcome|Fibrosis Stage F3|Participants with baseline fibrosis stage F3 (without cirrhosis).
30796|NCT02442271|O2|Outcome|Fibrosis Stage F4|Participants with baseline fibrosis stage F4 (with compensated cirrhosis).
30797|NCT02442271|O1|Outcome|Fibrosis Stage F3|Participants with baseline fibrosis stage F3 (without cirrhosis).
30798|NCT02442271|O2|Outcome|Fibrosis Stage F4|Participants with baseline fibrosis stage F4 (with compensated cirrhosis).
30799|NCT02442271|O1|Outcome|Fibrosis Stage F3|Participants with baseline fibrosis stage F3 (without cirrhosis).
30800|NCT02442271|O4|Outcome|Interferon (IFN)-Eligible, Treatment-Experienced|Participants who had received prior antiviral treatment for HCV infection and were eligible for treatment with IFN at screening.
30801|NCT02442271|O3|Outcome|Interferon (IFN)-Ineligible, Treatment-Experienced|Participants who had received prior antiviral treatment for HCV infection and were ineligible for treatment with IFN at screening.
30802|NCT02442271|O2|Outcome|Interferon (IFN)-Eligible, Treatment-Naive|Participants who had never received any antiviral treatment for HCV infection and were eligible for treatment with IFN at screening.
30803|NCT02442271|O1|Outcome|Interferon (IFN)-Ineligible, Treatment-Naive|Participants who had never received any antiviral treatment for HCV infection and were ineligible for treatment with IFN at screening.
30804|NCT02442271|O8|Outcome|Other|Participants who received IFN treatment, including IFN or pegIFN monotherapy, IFN/RBV, or pegIFN/RBV experienced subjects. Includes subjects who do not have adequate documentation of response.
30805|NCT02442271|O7|Outcome|IFN Interolerant|Participants who did not meet any of the other definitions of treatment failure and discontinued IFN/RBV or pegIFN/RBV therapy due to IFN intolerability
30806|NCT02442271|O6|Outcome|Pegylated Interferon (PegIFN)/RBV Breakthrough|Participants who had received prior treatment with pegIFN-based therapy for HCV infection and achieved at least one documented result of HCV RNA undetectable during a prior IFN/RBV or pegIFN/RBV treatment course
30807|NCT02442271|O5|Outcome|Pegylated Interferon (PegIFN)/RBV Relapser|Participants who had received prior treatment with pegIFN-based therapy for HCV infection who achieved HCV undetectable at end of a prior IFN/RBV or pegIFN/RBV treatment course but HCV RNA was detectable following cessation of therapy
30808|NCT02442271|O4|Outcome|Pegylated Interferon (PegIFN)/RBV Non-Responders|Participants who had received prior treatment with pegIFN-based therapy for HCV infection and failed to achieve a 1 log10 IU/mL reduction in HCV RNA by Week 4 or a 2 log10 IU/mL reduction in HCV RNA by Week 12 during a prior IFN/RBV or pegIFN/RBV treatment course.
30809|NCT02442271|O3|Outcome|Pegylated Interferon (PegIFN)//RBV Partial Responders|Participants who had received prior treatment with pegIFN-based therapy for HCV infection and achieved at least a 2 log10 IU/mL reduction in HCV RNA by Week 12 during a prior IFN/RBV or pegIFN/RBV treatment course but failed to achieve HCV RNA undetectable at the end of treatment
30810|NCT02442271|O2|Outcome|Pegylated Interferon (PegIFN)/RBV Null Responders|Participants who had received prior treatment with pegIFN-based therapy for HCV infection and failed to achieve a 1 log10 IU/mL reduction in HCV RNA by Week 4 or a 2 log10 IU/mL reduction in HCV RNA by Week 12 during a prior IFN/RBV or pegIFN/RBV treatment course
30811|NCT02442271|O1|Outcome|Treatment-Naive|Participants who had never received any antiviral treatment for HCV infection.
30812|NCT02442271|O2|Outcome|Fibrosis Stage F4|Participants with baseline fibrosis stage F4 (with compensated cirrhosis).
30813|NCT02442271|O1|Outcome|Fibrosis Stage F3|Participants with baseline fibrosis stage F3 (without cirrhosis).
30814|NCT02442271|O1|Outcome|3-DAA ± RBV|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
30815|NCT02442271|E1|Reported Event|3-DAA ± RBV|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
30816|NCT02441946|B4|Baseline|Total|Total of all reporting groups
30817|NCT02441946|B3|Baseline|Anastrozole|"Participants received 1 mg of anastrozole orally QD for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
30818|NCT02441946|B2|Baseline|Abemaciclib|"Participants received 150 mg of abemaciclib orally Q12H for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
39947|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
30819|NCT02441946|B1|Baseline|Abemaciclib + Anastrozole|"Participants were given 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
30820|NCT02441946|P3|Participant Flow|Anastrozole|"Participants received 1 mg of anastrozole orally QD for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
30821|NCT02441946|P2|Participant Flow|Abemaciclib|"Participants received 150 mg of abemaciclib orally Q12H for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
30822|NCT02441946|P1|Participant Flow|Abemaciclib + Anastrozole|"Participants were given 150 milligram (mg) of abemaciclib orally every 12 hours (Q12H) plus 1 mg of anastrozole orally once daily (QD) for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
30823|NCT02441946|O1|Outcome|Abemaciclib + Anastrozole|"Participants were given 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
30824|NCT02441946|O1|Outcome|Abemaciclib + Anastrozole|"Participants were given 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
30825|NCT02441946|O1|Outcome|Abemaciclib + Anastrozole|"Participants were given 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
30826|NCT02441946|O3|Outcome|Anastrozole|"Participants received 1 mg of anastrozole orally QD for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
30827|NCT02441946|O2|Outcome|Abemaciclib|"Participants received 150 mg of abemaciclib orally Q12H for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
30828|NCT02441946|O1|Outcome|Abemaciclib + Anastrozole|"Participants were given 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
30829|NCT02441946|E4|Reported Event|Abemaciclib + Anastrozole (Period 2)|"Combination Therapy: All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
30830|NCT02441946|E3|Reported Event|Anastrozole|"Participants received 1 mg of anastrozole orally QD for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
30831|NCT02441946|E2|Reported Event|Abemaciclib|"Participants received 150 mg of abemaciclib orally Q12H for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
30832|NCT02441946|E1|Reported Event|Abemaciclib + Anastrozole|"Participants were given 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for 2 weeks.~All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.~Total treatment duration was 16 weeks."
30833|NCT02441517|B1|Baseline|Enzalutamide|Participants received 160 mg enzalutamide orally once daily until radiographic or clinical progression, or unacceptable toxicity.
30834|NCT02441517|P1|Participant Flow|Enzalutamide|Participants received 160 mg enzalutamide orally once daily until radiographic or clinical progression, or unacceptable toxicity.
30835|NCT02441517|O1|Outcome|Enzalutamide|Participants received 160 mg enzalutamide orally once daily until radiographic or clinical progression, or unacceptable toxicity.
30836|NCT02441517|O1|Outcome|Enzalutamide|Participants received 160 mg enzalutamide orally once daily until radiographic or clinical progression, or unacceptable toxicity.
30837|NCT02441517|O1|Outcome|Enzalutamide|Participants received 160 mg enzalutamide orally once daily until radiographic or clinical progression, or unacceptable toxicity.
30838|NCT02441517|O1|Outcome|Enzalutamide|Participants received 160 mg enzalutamide orally once daily until radiographic or clinical progression, or unacceptable toxicity.
30839|NCT02441517|O1|Outcome|Enzalutamide|Participants received 160 mg enzalutamide orally once daily until radiographic or clinical progression, or unacceptable toxicity.
30840|NCT02441517|O1|Outcome|Enzalutamide|Participants received 160 mg enzalutamide orally once daily until radiographic or clinical progression, or unacceptable toxicity.
30841|NCT02441517|O1|Outcome|Enzalutamide|Participants received 160 mg enzalutamide orally once daily until radiographic or clinical progression, or unacceptable toxicity.
30842|NCT02441517|E1|Reported Event|Enzalutamide|Participants received 160 mg enzalutamide orally once daily until radiographic or clinical progression, or unacceptable toxicity.
30843|NCT02441218|B3|Baseline|Total|Total of all reporting groups
30844|NCT02441218|B2|Baseline|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
30845|NCT02441218|B1|Baseline|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
30846|NCT02441218|P2|Participant Flow|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
30847|NCT02441218|P1|Participant Flow|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
30848|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
31118|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
30849|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
30850|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
30851|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
30852|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
30853|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
30854|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
30855|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
30856|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
30857|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
30858|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
30859|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
30860|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
30861|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
30862|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
30863|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
30864|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
30865|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
30866|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
30867|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
30868|NCT02441218|E2|Reported Event|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
30869|NCT02441218|E1|Reported Event|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
30870|NCT02441179|B3|Baseline|Total|Total of all reporting groups
30871|NCT02441179|B2|Baseline|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
30872|NCT02441179|B1|Baseline|Intermittent Hypoxia Arm|"IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
30873|NCT02441179|P2|Participant Flow|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
30874|NCT02441179|P1|Participant Flow|Acute Intermittent Hypoxia Arm|"IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
30914|NCT02440633|E1|Reported Event|14C-OPS-2071|"Suspension containing 50 mg of 14C-OPS-2071~14C-OPS-2071: Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly."
30875|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
30876|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
30877|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
30878|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
30879|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
30880|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
30881|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
30882|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
30883|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
30884|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
30885|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
30886|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
30887|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
30888|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
30889|NCT02441179|E2|Reported Event|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
30890|NCT02441179|E1|Reported Event|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
30891|NCT02441114|B1|Baseline|Inhalation of HCP0910 and HGP1011|"Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.~The periods were separated with a washout period of 14 days."
30892|NCT02441114|P1|Participant Flow|Inhalation of HCP0910 and HGP1011|"Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.~The periods were separated with a washout period of 14 days."
30893|NCT02441114|O1|Outcome|Inhalation of HCP0910 and HGP1011|"Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.~The periods were separated with a washout period of 14 days."
30894|NCT02441114|O1|Outcome|Inhalation of HCP0910 and HGP1011|"Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.~The periods were separated with a washout period of 14 days."
30895|NCT02441114|O1|Outcome|Inhalation of HCP0910 and HGP1011|"Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.~The periods were separated with a washout period of 14 days."
30896|NCT02441114|E1|Reported Event|HCP0910 and HGP1011|"Single Inhalation of HCP0910 and HGP1011 (Open-label, Single-arm, Single dosing, Dose-escalation)~HCP0910 and HGP1011: Inhalation of HCP0910 (Seretide 250 diskus (Fluticasone Propionate 250 mcg/Salmeterol Xinafoate 72.5 mcg)) and HGP1011 (Spiriva capsule for inhalation (Micronized Tiotropium Bromide Monohydrate 22.5 mcg))"
30897|NCT02440659|B3|Baseline|Total|Total of all reporting groups
30898|NCT02440659|B2|Baseline|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
30899|NCT02440659|B1|Baseline|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
30900|NCT02440659|P2|Participant Flow|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
30901|NCT02440659|P1|Participant Flow|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
30902|NCT02440659|O2|Outcome|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
30903|NCT02440659|O1|Outcome|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
30904|NCT02440659|E2|Reported Event|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
30905|NCT02440659|E1|Reported Event|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
30906|NCT02440633|B1|Baseline|14C-OPS-2071|"Suspension containing 50 mg of 14C-OPS-2071~14C-OPS-2071: Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly."
30907|NCT02440633|P1|Participant Flow|14C-OPS-2071|"Suspension containing 50 mg of 14C-OPS-2071~14C-OPS-2071: Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly."
30908|NCT02440633|O1|Outcome|Plasma|
30909|NCT02440633|O2|Outcome|Whole Blood|
30910|NCT02440633|O1|Outcome|Plasma|
30911|NCT02440633|O3|Outcome|Total|
30912|NCT02440633|O2|Outcome|Urine|
30913|NCT02440633|O1|Outcome|Feces|
39948|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
30917|NCT02440308|O1|Outcome|68Ga-DOTA-Bombesin PET/MRI|Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
30918|NCT02440308|O1|Outcome|68Ga-DOTA-Bombesin PET/MRI|Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
30919|NCT02440308|E1|Reported Event|68Ga-DOTA-Bombesin PET/MRI|Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
30920|NCT02439879|B3|Baseline|Total|Total of all reporting groups
30921|NCT02439879|B2|Baseline|Alpha Lipoic Acid Withdrawal|After a decrease in the total symptoms Score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks no treatment
30922|NCT02439879|B1|Baseline|Alpha Lipoic Acid Treatment|"After a decrease in the total symptoms score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks 600 mg orally once a day of alpha lipoic acid~Alpha lipoic acid: Alpha lipoic acid 1800 mg PO divided in 3 doses for 4 weeks . If total symptoms score decreased >3 points patients received alpha lipoic acid 600 mg PO each day or no treatment for 16 weeks."
30923|NCT02439879|P2|Participant Flow|Alpha Lipoic Acid Withdrawal|After a decrease in the total symptoms Score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks no treatment
30924|NCT02439879|P1|Participant Flow|Alpha Lipoic Acid Treatment|After a decrease in the total symptoms score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks 600 mg orally once a day of alpha lipoic acid
30925|NCT02439879|O2|Outcome|Alpha Lipoic Acid Withdrawal|After a decrease in the total symptoms Score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks no treatment
30926|NCT02439879|O1|Outcome|Alpha Lipoic Acid Treatment|After a decrease in the total symptoms score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks 600 mg orally once a day of alpha lipoic acid
30927|NCT02439879|E2|Reported Event|Alpha Lipoic Acid Withdrawal|After a decrease in the total symptoms Score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks no treatment
30928|NCT02439879|E1|Reported Event|Alpha Lipoic Acid Treatment|After a decrease in the total symptoms score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks 600 mg orally once a day of alpha lipoic acid
30929|NCT02439164|B3|Baseline|Total|Total of all reporting groups
30930|NCT02439164|B2|Baseline|Non-neurosurgical Group|"patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.~Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
30931|NCT02439164|B1|Baseline|Glioma Group|"Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.~Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
30932|NCT02439164|P2|Participant Flow|Non-neurosurgical Group|"patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.~Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
30933|NCT02439164|P1|Participant Flow|Glioma Group|"Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.~Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
30934|NCT02439164|O1|Outcome|Glioma Group|"Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.~Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
30935|NCT02439164|O2|Outcome|Non-neurosurgical Group|"patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.~Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
30936|NCT02439164|O1|Outcome|Glioma Group|"Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.~Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
30937|NCT02439164|O2|Outcome|Non-neurosurgical Group|"patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.~Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
30938|NCT02439164|O1|Outcome|Glioma Group|"Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.~Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
30939|NCT02439164|O2|Outcome|Non-neurosurgical Group|"patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.~Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
30940|NCT02439164|O1|Outcome|Glioma Group|"Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.~Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
30941|NCT02439164|O2|Outcome|Non-neurosurgical Group|"patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.~Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
30942|NCT02439164|O1|Outcome|Glioma Group|"Patients in this group will be administered sedative midazolam titrating to mild sedation.~Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
39949|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
30943|NCT02439164|E2|Reported Event|Non-neurosurgical Group|"patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.~Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
30944|NCT02439164|E1|Reported Event|Glioma Group|"Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.~Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
30945|NCT02439138|B1|Baseline|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
30946|NCT02439138|P1|Participant Flow|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
30947|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
30948|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
30949|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
30950|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
30951|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
30952|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
30953|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
30954|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
30955|NCT02439138|E1|Reported Event|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
30956|NCT02438540|B3|Baseline|Total|Total of all reporting groups
30957|NCT02438540|B2|Baseline|Metformin & Placebo|"Metformin 500 mg, to control their diabetes during the period of this study as previously (with different therapeutic dosage) and placebo ( for acupuncture treatment including electro body acupuncture and Auricular acupuncture), needling not in right acupoints (for those points that were located in the abdomen, needles were inserted 0.3 cm laterally from the real location and the needling was maximally superficial. Those points that were located on other parts of the body, needles were inserted 0.5 cm up and 0.5 cm laterally from the real location and needling was superficial as well. Electric lines were connected with some of the needles same way they were connected in another case group. EA machine was switched off during 30 minutes of therapeutic time. Ear acupuncture was used on the same location as in the case group however we just used sticky layers without seeds), for 30 minutes, 10 times, every other day, for 3 weeks.~metformin Placebo (for acupuncture including electro"
30958|NCT02438540|B1|Baseline|Metformin & Acupuncture|"Metformin 500 mg, to control their diabetes during the period of this study as previously (with different therapeutic dosage) and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
30959|NCT02438540|P2|Participant Flow|Metformin & Placebo|Metformin 500 mg (one/two/three times per day) to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and electro acupuncture (EA) machine was switched off during 30 minutes of therapeutic time. And ear acupuncture was just used sticky layers without seeds. All placebo treatments used for 30 minutes, 10 times, every other day, for 3 weeks.
31037|NCT02437344|O1|Outcome|CI-581aa|"CI-581aa will be administered 24 hours after last opioid use, and followed by naltrexone dosing~CI-581aa: 92 minute infusion of CI-581aa~Naltrexone titration and XR-NTX initiation: participants will be provided a titration of naltrexone that culminates in the injection of XR-NTX"
30960|NCT02438540|P1|Participant Flow|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
30961|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
30962|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
30963|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
30964|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
30965|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
30966|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
30967|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
30968|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
30969|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
30970|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
30971|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
30972|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
30973|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
30974|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
30975|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
31213|NCT02436304|O2|Outcome|EXE844 3 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
30976|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
30977|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
30978|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
30979|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
30980|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
30981|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
30982|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
30983|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
30984|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
30985|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
30986|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
30987|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
30988|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
30989|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
30990|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
30991|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
31208|NCT02436304|P1|Participant Flow|EXE844 7 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, twice daily (BID) in each ear for 7 days after Tympanostomy Tube Insertion
30992|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
30993|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo EA and auricular acupuncture"
30994|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
30995|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
30996|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
30997|NCT02438540|E2|Reported Event|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
30998|NCT02438540|E1|Reported Event|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
30999|NCT02438137|B3|Baseline|Total|Total of all reporting groups
31000|NCT02438137|B2|Baseline|Placebo|"The placebo is an inert product that looks like a pill and is identical to dimethyl fumarate capsules, but it contains no medicine. Participants randomized to placebo were instructed to take placebo twice a day with breakfast and dinner for a period of 4 months.~Placebo: Placebo capsules were dispensed during routine study appointments. Placebo were dispensed in 1 month supply, so that compliance could be reconciled at monthly follow-up visits, and recorded in accountability logs. Participants were instructed to take the placebo with food, in the morning and at dinnertime. If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously missed a dose."
31001|NCT02438137|B1|Baseline|Dimethyl Fumarate (Tecfidera®) Capsules|"The starting dose for dimethyl fumarate was 120 mg twice a day orally. After 7 days, the dose was increased to the maintenance dose of 240 mg twice a day. Slower dose escalations were allowed to increase tolerability, if necessary. Participants randomized to dimethyl fumarate were instructed to take this medication twice a day with breakfast and dinner for a period of 4 months.~Dimethyl fumarate: Dimethyl fumarate capsules were dispensed at routine study appointments. 120 mg tablets were dispensed to facilitate dose titrations. Drug was dispensed in 1 month supply, so that compliance could be reconciled at follow-up visits, and recorded in accountability logs. Participants were instructed to take medication with food, (morning and at dinnertime). If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously miss a dose."
31002|NCT02438137|P2|Participant Flow|Placebo|"The placebo is an inert product that looks like a pill and is identical to dimethyl fumarate capsules, but it contains no medicine. Participants randomized to placebo were instructed to take placebo twice a day with breakfast and dinner for a period of 4 months.~Placebo: Placebo capsules were dispensed during routine study appointments. Placebo were dispensed in 1 month supply, so that compliance could be reconciled at monthly follow-up visits, and recorded in accountability logs. Participants were instructed to take the placebo with food, in the morning and at dinnertime. If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously missed a dose."
31003|NCT02438137|P1|Participant Flow|Dimethyl Fumarate (Tecfidera®) Capsules|"The starting dose for dimethyl fumarate was 120 mg twice a day orally. After 7 days, the dose was increased to the maintenance dose of 240 mg twice a day. Slower dose escalations were allowed to increase tolerability, if necessary. Participants randomized to dimethyl fumarate were instructed to take this medication twice a day with breakfast and dinner for a period of 4 months.~Dimethyl fumarate: Dimethyl fumarate capsules were dispensed at routine study appointments. 120 mg tablets were dispensed to facilitate dose titrations. Drug was dispensed in 1 month supply, so that compliance could be reconciled at follow-up visits, and recorded in accountability logs. Participants were instructed to take medication with food, (morning and at dinnertime). If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously miss a dose."
31004|NCT02438137|O2|Outcome|Placebo|"The placebo is an inert product that looks like a pill and is identical to dimethyl fumarate capsules, but it contains no medicine. Subjects randomized to placebo will be instructed to take placebo twice a day with breakfast and dinner for a period of 4 months.~Placebo: Placebo capsules were dispensed during routine study appointments. Placebo were dispensed in 1 month supply, so that compliance can be reconciled at monthly follow-up visits, and recorded in accountability logs. Subjects were instructed to take the placebo with food, in the morning and at dinnertime. If subjects missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously missed a dose."
31005|NCT02438137|O1|Outcome|Dimethyl Fumarate (Tecfidera®) Capsules|"The starting dose for dimethyl fumarate was 120 mg twice a day orally. After 7 days, the dose was increased to the maintenance dose of 240 mg twice a day, though slower dose escalations were possible to increase tolerability, if necessary. Subjects randomized to dimethyl fumarate were instructed to take this medication twice a day with breakfast and dinner for a period of 4 months.~Dimethyl fumarate: Dimethyl fumarate capsules were dispensed at routine study appointments. 120 mg tablets were dispensed to facilitate dose titrations. Drug was dispensed in 1 month supply, so that compliance was reconciled at follow-up visits, and recorded in accountability logs. Subjects were instructed to take medication with food, (morning and at dinnertime). If subjects missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously miss a dose."
31006|NCT02438137|O2|Outcome|Placebo|"The placebo is an inert product that looks like a pill and is identical to dimethyl fumarate capsules, but it contains no medicine. Participants randomized to placebo will be instructed to take placebo twice a day with breakfast and dinner for a period of 4 months.~Placebo: Placebo capsules were dispensed during routine study appointments. Placebo were dispensed in 1 month supply, so that compliance can be reconciled at monthly follow-up visits, and recorded in accountability logs. Participants were instructed to take the placebo with food, in the morning and at dinnertime. If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously missed a dose."
31007|NCT02438137|O1|Outcome|Dimethyl Fumarate (Tecfidera®) Capsules|"The starting dose for dimethyl fumarate was 120 mg twice a day orally. After 7 days, the dose was increased to the maintenance dose of 240 mg twice a day. Slower dose escalations were allowed to increase tolerability, if necessary. Participants randomized to dimethyl fumarate were instructed to take this medication twice a day with breakfast and dinner for a period of 4 months.~Dimethyl fumarate: Dimethyl fumarate capsules were dispensed at routine study appointments. 120 mg tablets were dispensed to facilitate dose titrations. Drug was dispensed in 1 month supply, so that compliance could be reconciled at follow-up visits, and recorded in accountability logs. Participants were instructed to take medication with food, (morning and at dinnertime). If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously miss a dose."
31008|NCT02438137|E2|Reported Event|Placebo|"The placebo is an inert product that looks like a pill and is identical to dimethyl fumarate capsules, but it contains no medicine. Participants randomized to placebo were instructed to take placebo twice a day with breakfast and dinner for a period of 4 months.~Placebo: Placebo capsules were dispensed during routine study appointments. Placebo were dispensed in 1 month supply, so that compliance could be reconciled at monthly follow-up visits, and recorded in accountability logs. Participants were instructed to take the placebo with food, in the morning and at dinnertime. If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously missed a dose."
31009|NCT02438137|E1|Reported Event|Dimethyl Fumarate (Tecfidera®) Capsules|"The starting dose for dimethyl fumarate was 120 mg twice a day orally. After 7 days, the dose was increased to the maintenance dose of 240 mg twice a day. Slower dose escalations were allowed to increase tolerability, if necessary. Participants randomized to dimethyl fumarate were instructed to take this medication twice a day with breakfast and dinner for a period of 4 months.~Dimethyl fumarate: Dimethyl fumarate capsules were dispensed at routine study appointments. 120 mg tablets were dispensed to facilitate dose titrations. Drug was dispensed in 1 month supply, so that compliance could be reconciled at follow-up visits, and recorded in accountability logs. Participants were instructed to take medication with food, (morning and at dinnertime). If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously miss a dose."
31010|NCT02437903|B1|Baseline|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.~JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6."
31011|NCT02437903|P1|Participant Flow|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.~JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6."
31012|NCT02437903|O1|Outcome|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.~JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6."
31013|NCT02437903|O1|Outcome|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.~JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6."
31014|NCT02437903|O1|Outcome|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.~JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6."
31038|NCT02437344|E1|Reported Event|CI-581aa|"CI-581aa will be administered 24 hours after last opioid use, and followed by naltrexone dosing~CI-581aa: 92 minute infusion of CI-581aa~Naltrexone titration and XR-NTX initiation: participants will be provided a titration of naltrexone that culminates in the injection of XR-NTX"
31039|NCT02437305|B3|Baseline|Total|Total of all reporting groups
31015|NCT02437903|O1|Outcome|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.~JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6."
31016|NCT02437903|O1|Outcome|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.~JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, month 6, month 9, and month 12"
31017|NCT02437903|E1|Reported Event|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.~JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6."
31018|NCT02437513|B1|Baseline|NewBreez|"The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician.~Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires.~NewBreez: Intralaryngeal prosthesis to protect the airways"
31019|NCT02437513|P1|Participant Flow|NewBreez|"The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician.~Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires.~NewBreez: Intralaryngeal prosthesis to protect the airways"
31020|NCT02437513|O1|Outcome|NewBreez|"The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician.~Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires.~NewBreez: Intralaryngeal prosthesis to protect the airways"
31021|NCT02437513|O1|Outcome|NewBreez|"The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician.~Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires.~NewBreez: Intralaryngeal prosthesis to protect the airways"
31022|NCT02437513|O1|Outcome|NewBreez|"The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician.~Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires.~NewBreez: Intralaryngeal prosthesis to protect the airways"
31023|NCT02437513|O1|Outcome|NewBreez|"The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician.~Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires.~NewBreez: Intralaryngeal prosthesis to protect the airways"
31024|NCT02437513|O1|Outcome|NewBreez|"The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician.~Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires.~NewBreez: Intralaryngeal prosthesis to protect the airways"
31025|NCT02437513|E1|Reported Event|NewBreez|"The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician.~Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires.~NewBreez: Intralaryngeal prosthesis to protect the airways"
31026|NCT02437409|B1|Baseline|All Patients|Treated with pREset Thrombectomy Retriever
31027|NCT02437409|P1|Participant Flow|All Patients|Treated with pREset Thrombectomy Retriever
31028|NCT02437409|O1|Outcome|Occluded Vessels|100 patients harboured 109 vessel occlusions
31029|NCT02437409|O1|Outcome|Occluded Vessels|100 patients harboured 109 vessel occlusions
31030|NCT02437409|O1|Outcome|All Patients|Treated with pREset Thrombectomy Retriever
31031|NCT02437409|O1|Outcome|All Patients|Treated with pREset Thrombectomy Retriever
31032|NCT02437409|O1|Outcome|All Patients|Treated with pREset Thrombectomy Retriever
31033|NCT02437409|O1|Outcome|All Patients|Treated with pREset Thrombectomy Retriever
31034|NCT02437409|E1|Reported Event|All Patients|Treated with pREset Thrombectomy Retriever
31035|NCT02437344|B1|Baseline|CI-581aa|"CI-581aa will be administered 24 hours after last opioid use, and followed by naltrexone dosing~CI-581aa: 92 minute infusion of CI-581aa~Naltrexone titration and XR-NTX initiation: participants will be provided a titration of naltrexone that culminates in the injection of XR-NTX"
31036|NCT02437344|P1|Participant Flow|CI-581aa|"CI-581aa will be administered 24 hours after last opioid use, and followed by naltrexone dosing~CI-581aa: 92 minute infusion of CI-581aa~Naltrexone titration and XR-NTX initiation: participants will be provided a titration of naltrexone that culminates in the injection of XR-NTX"
31209|NCT02436304|O3|Outcome|Tubes Only|Bilateral myringotomy and tympanostomy tube insertion
31040|NCT02437305|B2|Baseline|ABCDEs of Melanoma|"A conventional melanoma educational intervention using the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation.~ABCDEs of Melanoma: Conventional melanoma educational intervention."
31041|NCT02437305|B1|Baseline|ABCDEs of Melanoma Skin Cancer|"A modified melanoma educational intervention that uses the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature melanoma skin cancer; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.~ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color."
31042|NCT02437305|P2|Participant Flow|ABCDEs of Melanoma|"A conventional melanoma educational intervention using the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation.~ABCDEs of Melanoma: Conventional melanoma educational intervention."
31043|NCT02437305|P1|Participant Flow|ABCDEs of Melanoma Skin Cancer|"A modified melanoma educational intervention that uses the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature melanoma skin cancer; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.~ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color."
31044|NCT02437305|O2|Outcome|ABCDEs of Melanoma|"A conventional melanoma educational intervention using the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation.~ABCDEs of Melanoma: Conventional melanoma educational intervention."
31045|NCT02437305|O1|Outcome|ABCDEs of Melanoma Skin Cancer|"A modified melanoma educational intervention that uses the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature melanoma skin cancer; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.~ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color."
31046|NCT02437305|O2|Outcome|ABCDEs of Melanoma|"A conventional melanoma educational intervention using the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation.~ABCDEs of Melanoma: Conventional melanoma educational intervention."
31047|NCT02437305|O1|Outcome|ABCDEs of Melanoma Skin Cancer|"A modified melanoma educational intervention that uses the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature melanoma skin cancer; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.~ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color."
31048|NCT02437305|E2|Reported Event|ABCDEs of Melanoma|"A conventional melanoma educational intervention using the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation.~ABCDEs of Melanoma: Conventional melanoma educational intervention."
31049|NCT02437305|E1|Reported Event|ABCDEs of Melanoma Skin Cancer|"A modified melanoma educational intervention that uses the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature melanoma skin cancer; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.~ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color."
31050|NCT02437253|B3|Baseline|Total|Total of all reporting groups
31051|NCT02437253|B2|Baseline|Placebo First, Then Adalimumab|Participants first received Placebo saline subQ (volume matching Adalimumab 20 mg or 40 mg subQ) every other week for 16 weeks. Participants then received Adalimumab 20 mg subQ every other week (weight 15 to <30 kg) or 40 mg subQ every other week (weight ≥30 kg) for 16 weeks.
31052|NCT02437253|B1|Baseline|Adalimumab First, Then Placebo|Participants first received Adalimumab 20 mg subQ every other week (weight 15 to <30 kg) or 40 mg subQ every other week (weight ≥30 kg) for 16 weeks. Participants then received Placebo saline subQ (volume matching Adalimumab 20 mg or 40 mg subQ) every other week for 16 weeks.
31053|NCT02437253|P2|Participant Flow|Placebo First, Then Adalimumab|Participants first received Placebo saline subQ (volume matching Adalimumab 20 mg or 40 mg subQ) every other week. Participants then received Adalimumab 20 mg subQ every other week (weight 15 to <30 kg) or 40 mg subQ every other week (weight ≥30 kg) for 16 weeks.
31054|NCT02437253|P1|Participant Flow|Adalimumab First, Then Placebo|Participants first received Adalimumab 20 mg subQ every other week (weight 15 to <30 kg) or 40 mg subQ every other week (weight ≥30 kg) for 16 weeks. Participants then received Placebo saline subQ (volume matching Adalimumab 20 mg or 40 mg subQ) every other week.
31055|NCT02437253|O2|Outcome|Placebo First, Then Adalimumab|Participants first received Placebo saline subQ (volume matching Adalimumab 20 mg or 40 mg subQ) every other week. Participants then received Adalimumab 20 mg subQ every other week (weight 15 to <30 kg) or 40 mg subQ every other week (weight ≥30 kg) for 16 weeks.
31056|NCT02437253|O1|Outcome|Adalimumab First, Then Placebo|Participants first received Adalimumab 20 mg subQ every other week (weight 15 to <30 kg) or 40 mg subQ every other week (weight ≥30 kg) for 16 weeks. Participants then received Placebo saline subQ (volume matching Adalimumab 20 mg or 40 mg subQ) every other week.
31057|NCT02437253|O2|Outcome|Placebo First, Then Adalimumab|Participants first received Placebo saline subQ (volume matching Adalimumab 20 mg or 40 mg subQ) every other week. Participants then received Adalimumab 20 mg subQ every other week (weight 15 to <30 kg) or 40 mg subQ every other week (weight ≥30 kg) for 16 weeks.
31058|NCT02437253|O1|Outcome|Adalimumab First, Then Placebo|Participants first received Adalimumab 20 mg subQ every other week (weight 15 to <30 kg) or 40 mg subQ every other week (weight ≥30 kg) for 16 weeks. Participants then received Placebo saline subQ (volume matching Adalimumab 20 mg or 40 mg subQ) every other week.
31059|NCT02437253|O2|Outcome|Placebo First, Then Adalimumab|Participants first received Placebo saline subQ (volume matching Adalimumab 20 mg or 40 mg subQ) every other week. Participants then received Adalimumab 20 mg subQ every other week (weight 15 to <30 kg) or 40 mg subQ every other week (weight ≥30 kg) for 16 weeks.
31060|NCT02437253|O1|Outcome|Adalimumab First, Then Placebo|Participants first received Adalimumab 20 mg subQ every other week (weight 15 to <30 kg) or 40 mg subQ every other week (weight ≥30 kg) for 16 weeks. Participants then received Placebo saline subQ (volume matching Adalimumab 20 mg or 40 mg subQ) every other week for 16 weeks.
31061|NCT02437253|O2|Outcome|Placebo First, Then Adalimumab|Participants first received Placebo saline subQ (volume matching Adalimumab 20 mg or 40 mg subQ) every other week for 16 weeks. Participants then received Adalimumab 20 mg subQ every other week (weight 15 to <30 kg) or 40 mg subQ every other week (weight ≥30 kg) for 16 weeks.
31062|NCT02437253|O1|Outcome|Adalimumab First, Then Placebo|Participants first received Adalimumab 20 mg subQ every other week (weight 15 to <30 kg) or 40 mg subQ every other week (weight ≥30 kg) for 16 weeks. Participants then received Placebo saline subQ (volume matching Adalimumab 20 mg or 40 mg subQ) every other week for 16 weeks.
31063|NCT02437253|O2|Outcome|Placebo First, Then Adalimumab|Participants first received Placebo saline subQ (volume matching Adalimumab 20 mg or 40 mg subQ) every other week for 16 weeks. Participants then received Adalimumab 20 mg subQ every other week (weight 15 to <30 kg) or 40 mg subQ every other week (weight ≥30 kg) for 16 weeks.
31064|NCT02437253|O1|Outcome|Adalimumab First, Then Placebo|Participants first received Adalimumab 20 mg subQ every other week (weight 15 to <30 kg) or 40 mg subQ every other week (weight ≥30 kg) for 16 weeks. Participants then received Placebo saline subQ (volume matching Adalimumab 20 mg or 40 mg subQ) every other week for 16 weeks.
31065|NCT02437253|E2|Reported Event|Placebo|"Saline placebo injection~Placebo: Saline placebo"
31066|NCT02437253|E1|Reported Event|Adalimumab|"20 mg subQ every other week (weight 15 to <30 kg) 40 mg subQ every other week (weight ≥30 kg).~Adalimumab: Subjects will be treated with adalimumab (20 mg [weight 15-<30 kg] or 40 mg [weight ≥30 kg] administered subcutaneously [subQ] every other week) or placebo for 16 weeks, then cross-over to the other group for 16 weeks."
31067|NCT02437162|B4|Baseline|Total|Total of all reporting groups
31068|NCT02437162|B3|Baseline|Ustekinumab 90mg|Participants received ustekinumab 90 mg SC injection at Weeks 0, 4, and 16.
31069|NCT02437162|B2|Baseline|Ustekinumab 45 Milligram (mg)|Participants received Ustekinumab 45 mg SC injection at Weeks 0, 4, and 16.
31070|NCT02437162|B1|Baseline|Placebo|Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16.
31071|NCT02437162|P3|Participant Flow|Ustekinumab 90mg|Participants received ustekinumab 90 mg SC injection at Weeks 0, 4, and 16.
31072|NCT02437162|P2|Participant Flow|Ustekinumab 45 Milligram (mg)|Participants received Ustekinumab 45 mg SC injection at Weeks 0, 4, and 16.
31073|NCT02437162|P1|Participant Flow|Placebo|Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16.
31074|NCT02437162|O3|Outcome|Ustekinumab 90mg|Participants received ustekinumab 90 mg SC injection at Weeks 0, 4, and 16.
31075|NCT02437162|O2|Outcome|Ustekinumab 45 Milligram (mg)|Participants received Ustekinumab 45 mg SC injection at Weeks 0, 4, and 16.
31076|NCT02437162|O1|Outcome|Placebo|Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16.
31077|NCT02437162|E3|Reported Event|Ustekinumab 90 mg Only|Participants received ustekinumab 90 mg SC injection at Weeks 0, 4, and 16.
31078|NCT02437162|E2|Reported Event|Ustekinumab 45 mg Only|Participants received Ustekinumab 45 mg SC injection at Weeks 0, 4, and 16.
31079|NCT02437162|E1|Reported Event|Placebo Only|Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16.
31080|NCT02436811|B4|Baseline|Total|Total of all reporting groups
31081|NCT02436811|B3|Baseline|Control|60 women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
31082|NCT02436811|B2|Baseline|Written Form Instruction|60 women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).
31083|NCT02436811|B1|Baseline|Standardized Oral Instruction|60 women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.
31084|NCT02436811|P3|Participant Flow|Control|women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
31085|NCT02436811|P2|Participant Flow|Written Form Instruction|women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).
31086|NCT02436811|P1|Participant Flow|Standardized Oral Instruction|women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.
31087|NCT02436811|O3|Outcome|Control|women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
31088|NCT02436811|O2|Outcome|Written Form Instruction|women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).
31117|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
39950|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
31089|NCT02436811|O1|Outcome|Standardized Oral Instruction|women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.
31090|NCT02436811|E3|Reported Event|Control|60 women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
31091|NCT02436811|E2|Reported Event|Written Form Instruction|60 women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).
31092|NCT02436811|E1|Reported Event|Standardized Oral Instruction|60 women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.
31093|NCT02436577|B7|Baseline|Total|Total of all reporting groups
31094|NCT02436577|B6|Baseline|CBA Sequence|Subjects were administered a single dose of Treatment C, B and A as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
31095|NCT02436577|B5|Baseline|BAC Sequence|Subjects were administered a single dose of Treatment B, A and C as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
31096|NCT02436577|B4|Baseline|ACB Sequence|Subjects were administered a single dose of Treatment A, C and B as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
31097|NCT02436577|B3|Baseline|CAB Sequence|Subjects were administered a single dose of Treatment C, A and B as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
31098|NCT02436577|B2|Baseline|BCA Sequence|Subjects were administered a single dose of Treatment B, C and A as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
31099|NCT02436577|B1|Baseline|ABC Sequence|Subjects were administered a single dose of Treatment A, B and C as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
31100|NCT02436577|P6|Participant Flow|CBA Sequence|Subjects were administered a single dose of Treatment C, B and A as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
31101|NCT02436577|P5|Participant Flow|BAC Sequence|Subjects were administered a single dose of Treatment B, A and C as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
31102|NCT02436577|P4|Participant Flow|ACB Sequence|Subjects were administered a single dose of Treatment A, C and B as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
31103|NCT02436577|P3|Participant Flow|CAB Sequence|Subjects were administered a single dose of Treatment C, A and B as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
31104|NCT02436577|P2|Participant Flow|BCA Sequence|Subjects were administered a single dose of Treatment B, C and A as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
31105|NCT02436577|P1|Participant Flow|ABC Sequence|Subjects were administered a single dose of Treatment A, B and C as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
31106|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
31107|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
31108|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
31109|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
31110|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
31111|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
31112|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
31113|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
31114|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
31115|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
31116|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
39951|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
31119|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
31120|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
31121|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
31122|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
31123|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
31124|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
31125|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
31126|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
31127|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
31128|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
31129|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
31130|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
31131|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
31132|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
31133|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
31134|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
31135|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
31136|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
31137|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
31138|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
31139|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
31140|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
31141|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
31142|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
31143|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
31144|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
31145|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
31146|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
31147|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
31148|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
31149|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
31150|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
31151|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
31152|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
31153|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
31154|NCT02436577|E3|Reported Event|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
31155|NCT02436577|E2|Reported Event|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
31156|NCT02436577|E1|Reported Event|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
31157|NCT02436330|B3|Baseline|Total|Total of all reporting groups
31158|NCT02436330|B2|Baseline|Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.~Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour didactic health teaching sessions for the remainder of the 6 month period."
31159|NCT02436330|B1|Baseline|Exergaming and Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.~Exergaming and Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 2- hour sessions:1 hour of exergaming and 1 hour of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour maintenance didactic teaching for the remainder of the 6 month period."
31160|NCT02436330|P2|Participant Flow|Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.~Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour didactic health teaching sessions for the remainder of the 6 month period.~n = 24 (29%) enrolled within 6 cohorts during the study period from April 2011 to September 2013"
31161|NCT02436330|P1|Participant Flow|Exergaming and Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.~Exergaming and Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 2- hour sessions:1 hour of exergaming and 1 hour of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour maintenance didactic teaching for the remainder of the 6 month period.~n = 60 (71%) enrolled within 6 cohorts over the study period from April 2011 to September 2013."
31162|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Subjects remaining in the study at 1 year post start of participation in the exergaming combined with didactic health teaching sessions, 14 sessions over 6 month period, followed by 6 months of non-participation in group activity.
31163|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Subjects remaining in the study at 1 year post start of participation in the exergaming combined with didactic health teaching sessions, 14 sessions over 6 month period, followed by 6 months of non-participation in group activity.
31164|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Subjects remaining in the study at 1 year post start of participation in the exergaming combined with didactic health teaching sessions, 14 sessions over 6 month period, followed by 6 months of non-participation in group activity.
31165|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Subjects remaining in the study at 1 year post start of participation in the exergaming combined with didactic health teaching sessions, 14 sessions over 6 month period, followed by 6 months of non-participation in group activity.
31166|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Intervention group subjects (exergaming combined with didactic nutrition teaching) with continued participation at 6 months completed this questionnaire regarding attitudes/perceptions towards participation.
31167|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
31168|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
31169|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
31170|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
31171|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
31172|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
31173|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
31174|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
31175|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
31176|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
31177|NCT02436330|O2|Outcome|Didactic Health Teaching|Subjects only receiving classroom structured nutrition/health education.
31178|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Subjects attending exergaming/physical activity along with classroom structured nutrition/health education.
31210|NCT02436304|O2|Outcome|EXE844 3 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
31211|NCT02436304|O1|Outcome|EXE844 7 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, BID in each ear for 7 days after Tympanostomy Tube Insertion
31179|NCT02436330|O2|Outcome|Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.~Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour didactic health teaching sessions for the remainder of the 6 month period."
31180|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.~Exergaming and Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 2- hour sessions:1 hour of exergaming and 1 hour of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour maintenance didactic teaching for the remainder of the 6 month period."
31181|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
31182|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
31183|NCT02436330|O2|Outcome|Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.~Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour didactic health teaching sessions for the remainder of the 6 month period."
31184|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.~Exergaming and Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 2- hour sessions:1 hour of exergaming and 1 hour of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour maintenance didactic teaching for the remainder of the 6 month period."
31185|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
31186|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
31187|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
31188|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
31189|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
31190|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
31191|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
31192|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
31193|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
31194|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
31195|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
31196|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
31197|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Subjects remaining in the study at 1 year post start of participation in the exergaming combined with didactic health teaching sessions, 14 sessions over 6 month period, followed by 6 months of non-participation in group activity.
31198|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
31199|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
31200|NCT02436330|E2|Reported Event|Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.~Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour didactic health teaching sessions for the remainder of the 6 month period."
31201|NCT02436330|E1|Reported Event|Exergaming and Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.~Exergaming and Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 2- hour sessions:1 hour of exergaming and 1 hour of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour maintenance didactic teaching for the remainder of the 6 month period."
31202|NCT02436304|B4|Baseline|Total|Total of all reporting groups
31203|NCT02436304|B3|Baseline|Tubes Only|Bilateral myringotomy and tympanostomy tube insertion
31204|NCT02436304|B2|Baseline|EXE844 3 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
31205|NCT02436304|B1|Baseline|EXE844 7 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, BID in each ear for 7 days after Tympanostomy Tube Insertion
31206|NCT02436304|P3|Participant Flow|Tubes Only|Bilateral myringotomy and tympanostomy tube insertion
31207|NCT02436304|P2|Participant Flow|EXE844 3 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
31214|NCT02436304|O1|Outcome|EXE844 7 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, BID in each ear for 7 days after Tympanostomy Tube Insertion
31215|NCT02436304|O3|Outcome|Tubes Only|Bilateral myringotomy and tympanostomy tube insertion
31216|NCT02436304|O2|Outcome|EXE844 3 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
31217|NCT02436304|O1|Outcome|EXE844 7 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, BID in each ear for 7 days after Tympanostomy Tube Insertion
31218|NCT02436304|E4|Reported Event|Tubes Only|All participants who underwent bilateral myringotomy and tympanostomy tube insertion only
31219|NCT02436304|E3|Reported Event|EXE844 3 Days|All participants exposed to EXE844 Sterile Otic Suspension, 0.3%, for 3 days after Tympanostomy Tube Insertion
31220|NCT02436304|E2|Reported Event|EXE844 7 Days|All participants exposed to EXE844 Sterile Otic Suspension, 0.3% for 7 days after Tympanostomy Tube Insertion
31221|NCT02436304|E1|Reported Event|Pretreatment|All who consented to participate in the study prior to randomization
31222|NCT02436031|B1|Baseline|All Analyzed Participants|All participants who were randomized, completed both study nights, and were included in the analysis. 1 participant was excluded due to insufficient sleep time.
31223|NCT02436031|P2|Participant Flow|Placebo First, Desipramine Second|Placebo-matching desipramine administered 2 hours before normal sleep time on first study night, then a 1-week non-treatment period, then desipramine administered 2 hours before normal sleep time on second study night.
31224|NCT02436031|P1|Participant Flow|Desipramine First, Placebo Second|Desipramine 200 mg administered 2 hours before normal sleep time on first study night, then a 1-week non-treatment period, then placebo-matching desipramine administered 2 hours before normal sleep time on second study night.
31225|NCT02436031|O2|Outcome|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
31226|NCT02436031|O1|Outcome|Desipramine|Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
31227|NCT02436031|O2|Outcome|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
31228|NCT02436031|O1|Outcome|Desipramine|Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
31229|NCT02436031|O2|Outcome|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
31230|NCT02436031|O1|Outcome|Desipramine|Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
31231|NCT02436031|E2|Reported Event|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
31232|NCT02436031|E1|Reported Event|Desipramine|Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
31233|NCT02435966|B4|Baseline|Total|Total of all reporting groups
31234|NCT02435966|B3|Baseline|Untreated Control|Natural history of the condition
31235|NCT02435966|B2|Baseline|Manual Therapy + Sham Dry Needling|"Manual therapy + Sham Dry needling: after a 7 days interval~Sham Dry needling: Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
31236|NCT02435966|B1|Baseline|Manual Therapy + Dry Needling|"Manual therapy + Dry needling: 2 sessions, after a 7 days interval~Dry needling: Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
31237|NCT02435966|P3|Participant Flow|Untreated Control|Natural history of the condition
31238|NCT02435966|P2|Participant Flow|Manual Therapy + Sham Dry Needling|"Manual therapy + Sham Dry needling: after a 7 days interval~Sham Dry needling: Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
31239|NCT02435966|P1|Participant Flow|Manual Therapy + Dry Needling|"Manual therapy + Dry needling: 2 sessions, after a 7 days interval~Dry needling: Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
31240|NCT02435966|O3|Outcome|Untreated Control|Natural history of the condition
31241|NCT02435966|O2|Outcome|Manual Therapy + Sham Dry Needling|"Manual therapy + Sham Dry needling: after a 7 days interval~Sham Dry needling: Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
31242|NCT02435966|O1|Outcome|Manual Therapy + Dry Needling|"Manual therapy + Dry needling: 2 sessions, after a 7 days interval~Dry needling: Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
31243|NCT02435966|E3|Reported Event|Untreated Control|Natural history of the condition
31244|NCT02435966|E2|Reported Event|Manual Therapy + Sham Dry Needling|"Manual therapy + Sham Dry needling: after a 7 days interval~Sham Dry needling: Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
31245|NCT02435966|E1|Reported Event|Manual Therapy + Dry Needling|"Manual therapy + Dry needling: 2 sessions, after a 7 days interval~Dry needling: Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
31246|NCT02435836|B1|Baseline|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
31247|NCT02435836|P1|Participant Flow|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
31248|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
31249|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
31250|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
31251|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
31252|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
31253|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
31254|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
31255|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
31256|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
31257|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
31258|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
31259|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
31260|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
31261|NCT02435836|E1|Reported Event|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
31262|NCT02435277|B5|Baseline|Total|Total of all reporting groups
31263|NCT02435277|B4|Baseline|Control|850mg Metformin
31264|NCT02435277|B3|Baseline|FDC 500|Leucine 1100mg +Metformin 500mg
31265|NCT02435277|B2|Baseline|FDC 250|Leucine 1100mg +Metformin 250mg
31266|NCT02435277|B1|Baseline|FDC 125|Leucine 1100mg +Metformin 125mg
31267|NCT02435277|P4|Participant Flow|Control|850mg Metformin
31268|NCT02435277|P3|Participant Flow|FDC 500|Leucine 1100mg +Metformin 500mg
31269|NCT02435277|P2|Participant Flow|FDC 250|Leucine 1100mg +Metformin 250mg
31270|NCT02435277|P1|Participant Flow|FDC 125|Leucine 1100mg +Metformin 125mg
31271|NCT02435277|O4|Outcome|Control|850mg Metformin
31272|NCT02435277|O3|Outcome|FDC 500|Leucine 1100mg +Metformin 500mg
31273|NCT02435277|O2|Outcome|FDC 250|Leucine 1100mg +Metformin 250mg
31274|NCT02435277|O1|Outcome|FDC 125|Leucine 1100mg +Metformin 125mg
31275|NCT02435277|O4|Outcome|Control|850mg Metformin
31276|NCT02435277|O3|Outcome|FDC 500|Leucine 1100mg +Metformin 500mg
31277|NCT02435277|O2|Outcome|FDC 250|Leucine 1100mg +Metformin 250mg
31278|NCT02435277|O1|Outcome|FDC 125|Leucine 1100mg +Metformin 125mg
31279|NCT02435277|E4|Reported Event|Control|850mg Metformin
31280|NCT02435277|E3|Reported Event|FDC 500|Leucine 1100mg +Metformin 500mg
31281|NCT02435277|E2|Reported Event|FDC 250|Leucine 1100mg +Metformin 250mg
31284|NCT02434939|B2|Baseline|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.~Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
31285|NCT02434939|B1|Baseline|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.~Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
31286|NCT02434939|P2|Participant Flow|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.~Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
31287|NCT02434939|P1|Participant Flow|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.~Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
31288|NCT02434939|O2|Outcome|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.~Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
31289|NCT02434939|O1|Outcome|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.~Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
31290|NCT02434939|O2|Outcome|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes . Maximum of 2 doses to be given during the study period that will last 2 hours.~Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
31291|NCT02434939|O1|Outcome|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.~Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
31292|NCT02434939|O2|Outcome|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.~Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
31293|NCT02434939|O1|Outcome|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.~Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
31294|NCT02434939|O2|Outcome|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.~Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
31295|NCT02434939|O1|Outcome|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.~Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
31296|NCT02434939|E2|Reported Event|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.~Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
31297|NCT02434939|E1|Reported Event|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.~Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
31298|NCT02434523|B3|Baseline|Total|Total of all reporting groups
31299|NCT02434523|B2|Baseline|Placebo|Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
31300|NCT02434523|B1|Baseline|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
31301|NCT02434523|P2|Participant Flow|Placebo|Subjects in this arm will receive pills composed only of Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
31347|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31348|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31302|NCT02434523|P1|Participant Flow|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
31303|NCT02434523|O2|Outcome|Placebo|Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
31304|NCT02434523|O1|Outcome|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
31305|NCT02434523|O2|Outcome|Placebo|"Subjects in this arm will receive pills composed only of Avicel (cellulose filler)~Placebo: Placebo pill"
31306|NCT02434523|O1|Outcome|Amitriptyline|"Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler)~Amitriptyline"
31307|NCT02434523|O2|Outcome|Placebo|Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
31308|NCT02434523|O1|Outcome|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
31309|NCT02434523|O2|Outcome|Placebo|Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
31310|NCT02434523|O1|Outcome|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
31311|NCT02434523|E2|Reported Event|Placebo|Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
31312|NCT02434523|E1|Reported Event|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
31313|NCT02434497|B1|Baseline|Overall|All patients
31314|NCT02434497|P1|Participant Flow|Overall|All patients
31315|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31316|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31317|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31318|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31319|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31320|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31321|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31322|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31323|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31324|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31325|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31326|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31327|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31328|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31329|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31330|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31331|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31332|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31333|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31334|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31335|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31336|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31337|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31338|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31339|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31340|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31341|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31342|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31343|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31344|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31345|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31349|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31350|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31351|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31352|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31353|NCT02434497|O1|Outcome|Full Analysis Set|Full analysis set, comprised of patient who received at least one dose of study drug.
31354|NCT02434497|O1|Outcome|Full Analysis Set|Full analysis set, comprised of patient who received at least one dose of study drug.
31355|NCT02434497|O1|Outcome|Full Analysis Set|Full analysis set, comprised of patient who received at least one dose of study drug.
31356|NCT02434497|O1|Outcome|Full Analysis Set|Full analysis set, comprised of patient who received at least one dose of study drug.
31357|NCT02434497|O1|Outcome|Full Analysis Set|Full analysis set, comprised of patient who received at least one dose of study drug.
31358|NCT02434497|O1|Outcome|Full Analysis Set|Full analysis set, comprised of patient who received at least one dose of study drug.
31359|NCT02434497|O1|Outcome|Full Analysis Set|Full analysis set, comprised of patient who received at least one dose of study drug.
31360|NCT02434497|O1|Outcome|Full Analysis Set|Full analysis set, comprised of patient who received at least one dose of study drug.
31361|NCT02434497|O1|Outcome|Full Analysis Set|Full analysis set, comprised of patient who received at least one dose of study drug.
31362|NCT02434497|O1|Outcome|Full Analysis Set|Full analysis set, comprised of patient who received at least one dose of study drug.
31363|NCT02434497|O1|Outcome|Full Analysis Set|Full analysis set, comprised of patient who received at least one dose of study drug.
31364|NCT02434497|O1|Outcome|Full Analysis Set|Full analysis set, comprised of patient who received at least one dose of study drug.
31365|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31366|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31367|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31368|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31369|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31370|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31371|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31372|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31373|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31374|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31375|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31376|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31377|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31378|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31379|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31380|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31381|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31382|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31383|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31384|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31385|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31386|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31387|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31388|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31389|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31390|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31391|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31392|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31393|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31394|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31395|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31396|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31397|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31398|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31399|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31400|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31401|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31402|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31403|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31404|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31405|NCT02434497|O1|Outcome|Full Analysis Set|Full analysis set, comprised of patient who received at least one dose of study drug.
31406|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31407|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31408|NCT02434497|O2|Outcome|Sequence B|Placebo/Rosuva in the D3561C00004 cross-over phase
31409|NCT02434497|O1|Outcome|Sequence A|Rosuva/Placebo in the D3561C00004 cross-over phase
31410|NCT02434497|O1|Outcome|Full Analysis Set|Full analysis set, comprised of patient who received at least one dose of study drug.
31411|NCT02434497|O1|Outcome|Full Analysis Set|Full analysis set, comprised of patient who received at least one dose of study drug.
31412|NCT02434497|E1|Reported Event|Overall|All patients
31413|NCT02434471|B1|Baseline|All Subjects|All study subjects
31414|NCT02434471|P1|Participant Flow|All Subjects|All study subjects
31415|NCT02434471|O2|Outcome|Respiratory-triggered T1w DISCO LAVA|"The study will acquire extra image sets using DISCO LAVA with one breath hold during the arterial imaging phase. No additional breath holds will be required.~Respiratory-triggered T1w DISCO LAVA: The study will acquire extra image sets using DISCO LAVA with one breath hold during the arterial imaging phase. No additional breath holds will be required.~Respiratory-triggered T1w DISCO LAVA precontrast~Respiratory-triggered T1w DISCO LAVA in the portal venous phase~Respiratory-triggered T1w DISCO LAVA in the equilibrium phase"
31416|NCT02434471|O1|Outcome|Breath Hold Liver Acquisition With Volume Acquisition (LAVA)|Subjects will undergo abdominal MRI with LAVA with conventional breath holds (typically four or more breath holds) per standard of care.
31417|NCT02434471|O2|Outcome|Respiratory-triggered T1w DISCO LAVA|"The study will acquire extra image sets using DISCO LAVA with one breath hold during the arterial imaging phase. No additional breath holds will be required.~Respiratory-triggered T1w DISCO LAVA: The study will acquire extra image sets using DISCO LAVA with one breath hold during the arterial imaging phase. No additional breath holds will be required.~Respiratory-triggered T1w DISCO LAVA precontrast~Respiratory-triggered T1w DISCO LAVA in the portal venous phase~Respiratory-triggered T1w DISCO LAVA in the equilibrium phase"
31418|NCT02434471|O1|Outcome|Breath Hold Liver Acquisition With Volume Acquisition (LAVA)|Subjects will undergo abdominal MRI with LAVA with conventional breath holds (typically four or more breath holds) per standard of care.
31419|NCT02434471|E1|Reported Event|All Subjects|All subjects who completed the study
31420|NCT02434146|B1|Baseline|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
31421|NCT02434146|P1|Participant Flow|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
31422|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
31423|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
31424|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
31425|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
31426|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
31427|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
31428|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
31429|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
31430|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
31533|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
34323|NCT02409459|O2|Outcome|Placebo|"15 cc of Normal Saline IV push at 2 ml/minute~Normal Saline"
31431|NCT02434146|E1|Reported Event|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
31432|NCT02433834|B1|Baseline|Overall Study|All patients randomized
31433|NCT02433834|P1|Participant Flow|Overall Study|All patients randomized
31434|NCT02433834|O7|Outcome|SAL 50 µg|salmeterol 50 µg
31435|NCT02433834|O6|Outcome|Placebo MDI|Placebo MDI.
31436|NCT02433834|O5|Outcome|GP MDI 1.9 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 1.9 µg
31437|NCT02433834|O4|Outcome|GP MDI 3.6 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 3.6 µg
31438|NCT02433834|O3|Outcome|GP MDI 7.2 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 7.2 µg
31439|NCT02433834|O2|Outcome|GP MDI 14.4 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 14.4 µg
31440|NCT02433834|O1|Outcome|GP MDI 28.8 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 28.8 µg
31441|NCT02433834|O7|Outcome|SAL 50 µg|salmeterol 50 µg
31442|NCT02433834|O6|Outcome|Placebo MDI|Placebo MDI.
31443|NCT02433834|O5|Outcome|GP MDI 1.9 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 1.9 µg
31444|NCT02433834|O4|Outcome|GP MDI 3.6 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 3.6 µg
31445|NCT02433834|O3|Outcome|GP MDI 7.2 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 7.2 µg
31446|NCT02433834|O2|Outcome|GP MDI 14.4 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 14.4 µg
31447|NCT02433834|O1|Outcome|GP MDI 28.8 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 28.8 µg
31448|NCT02433834|O7|Outcome|SAL 50 µg|salmeterol 50 µg
31449|NCT02433834|O6|Outcome|Placebo MDI|Placebo MDI.
31450|NCT02433834|O5|Outcome|GP MDI 1.9 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 1.9 µg
31451|NCT02433834|O4|Outcome|GP MDI 3.6 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 3.6 µg
31452|NCT02433834|O3|Outcome|GP MDI 7.2 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 7.2 µg
31453|NCT02433834|O2|Outcome|GP MDI 14.4 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 14.4 µg
31454|NCT02433834|O1|Outcome|GP MDI 28.8 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 28.8 µg
31455|NCT02433834|O7|Outcome|SAL 50 µg|salmeterol 50 µg
31456|NCT02433834|O6|Outcome|Placebo MDI|Placebo MDI.
31457|NCT02433834|O5|Outcome|GP MDI 1.9 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 1.9 µg
31458|NCT02433834|O4|Outcome|GP MDI 3.6 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 3.6 µg
31459|NCT02433834|O3|Outcome|GP MDI 7.2 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 7.2 µg
31460|NCT02433834|O2|Outcome|GP MDI 14.4 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 14.4 µg
31461|NCT02433834|O1|Outcome|GP MDI 28.8 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 28.8 µg
31462|NCT02433834|O7|Outcome|SAL 50 µg|salmeterol 50 µg
31463|NCT02433834|O6|Outcome|Placebo MDI|Placebo MDI.
31464|NCT02433834|O5|Outcome|GP MDI 1.9 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 1.9 µg
31465|NCT02433834|O4|Outcome|GP MDI 3.6 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 3.6 µg
31466|NCT02433834|O3|Outcome|GP MDI 7.2 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 7.2 µg
31467|NCT02433834|O2|Outcome|GP MDI 14.4 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 14.4 µg
31468|NCT02433834|O1|Outcome|GP MDI 28.8 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 28.8 µg
31469|NCT02433834|O7|Outcome|SAL 50 µg|salmeterol 50 µg
31470|NCT02433834|O6|Outcome|Placebo MDI|Placebo MDI.
31471|NCT02433834|O5|Outcome|GP MDI 1.9 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 1.9 µg
31472|NCT02433834|O4|Outcome|GP MDI 3.6 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 3.6 µg
31473|NCT02433834|O3|Outcome|GP MDI 7.2 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 7.2 µg
31474|NCT02433834|O2|Outcome|GP MDI 14.4 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 14.4 µg
31475|NCT02433834|O1|Outcome|GP MDI 28.8 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 28.8 µg
31476|NCT02433834|O7|Outcome|SAL 50 µg|salmeterol 50 µg
31477|NCT02433834|O6|Outcome|Placebo MDI|Placebo MDI.
31478|NCT02433834|O5|Outcome|GP MDI 1.9 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 1.9 µg
31479|NCT02433834|O4|Outcome|GP MDI 3.6 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 3.6 µg
31480|NCT02433834|O3|Outcome|GP MDI 7.2 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 7.2 µg
31481|NCT02433834|O2|Outcome|GP MDI 14.4 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 14.4 µg
31482|NCT02433834|O1|Outcome|GP MDI 28.8 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 28.8 µg
31483|NCT02433834|E7|Reported Event|SAL 50 µg|salmeterol 50 µg
31484|NCT02433834|E6|Reported Event|Placebo MDI|Placebo MDI.
31485|NCT02433834|E5|Reported Event|GP MDI 1.9 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 1.9 µg
31486|NCT02433834|E4|Reported Event|GP MDI 3.6 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 3.6 µg
31487|NCT02433834|E3|Reported Event|GP MDI 7.2 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 7.2 µg
31488|NCT02433834|E2|Reported Event|GP MDI 14.4 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 14.4 µg
31489|NCT02433834|E1|Reported Event|GP MDI 28.8 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 28.8 µg
31490|NCT02433483|B1|Baseline|Myeloid Malignancies|"Includes participants with AML and MDS. Participants receive chemotherapy based on diagnosis followed by infusion of donor HPC-A.~Participants with CNS disease receive weekly age-adjusted intrathecal triples therapy until the cerebrospinal fluid becomes free of leukemia (minimum of 4 doses).~Interventions:~Cycle 1: cytarabine, HPC-A donor infusion~Cycle 2: Participants who have at least a partial response to Cycle 1 are eligible to receive Cycle 2: cytarabine, HPC-A infusion~Cytarabine: Given by either intrathecal (IT) or intravenous (IV) route.~Intrathecal Triples: given IT.~HPC-A: Given IV."
31534|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
34453|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
31491|NCT02433483|P1|Participant Flow|Myeloid Malignancies|"Includes participants with AML and MDS. Participants receive chemotherapy based on diagnosis followed by infusion of donor HPC-A.~Participants with CNS disease receive weekly age-adjusted intrathecal triples therapy until the cerebrospinal fluid becomes free of leukemia (minimum of 4 doses).~Interventions:~Cycle 1: cytarabine, HPC-A donor infusion~Cycle 2: Participants who have at least a partial response to Cycle 1 are eligible to receive Cycle 2: cytarabine, HPC-A infusion~Cytarabine: Given by either intrathecal (IT) or intravenous (IV) route.~Intrathecal Triples: given IT.~HPC-A: Given IV."
31492|NCT02433483|O1|Outcome|Myeloid Malignancies|Includes participants with AML and MDS. Participants receive chemotherapy based on diagnosis followed by infusion of donor HPC-A.
31493|NCT02433483|O1|Outcome|Myeloid Malignancies|Includes participants with AML and MDS. Participants receive chemotherapy based on diagnosis followed by infusion of donor HPC-A.
31494|NCT02433483|O1|Outcome|Myeloid Malignancies|Includes participants with AML and MDS. Participants receive chemotherapy based on diagnosis followed by infusion of donor HPC-A.
31495|NCT02433483|O1|Outcome|Myeloid Malignancies|Includes participants with AML and MDS. Participants receive chemotherapy based on diagnosis followed by infusion of donor HPC-A.
31496|NCT02433483|O1|Outcome|Myeloid Malignancies|Includes participants with AML and MDS. Participants receive chemotherapy based on diagnosis followed by infusion of donor HPC-A.
31497|NCT02433483|O1|Outcome|Myeloid Malignancies|Includes participants with AML and MDS. Participants receive chemotherapy based on diagnosis followed by infusion of donor HPC-A.
31498|NCT02433483|O1|Outcome|Myeloid Malignancies|Includes participants with AML and MDS. Participants receive chemotherapy based on diagnosis followed by infusion of donor HPC-A.
31499|NCT02433483|O1|Outcome|Myeloid Malignancies|Includes participants with AML and MDS. Participants receive chemotherapy based on diagnosis followed by infusion of donor HPC-A.
31500|NCT02433483|O1|Outcome|Myeloid Malignancies|Includes participants with AML and MDS. Participants receive chemotherapy based on diagnosis followed by infusion of donor HPC-A.
31501|NCT02433483|E1|Reported Event|Myeloid Malignancies|"Includes participants with AML and MDS. Participants receive chemotherapy based on diagnosis followed by infusion of donor HPC-A.~Participants with CNS disease receive weekly age-adjusted intrathecal triples therapy until the cerebrospinal fluid becomes free of leukemia (minimum of 4 doses).~Interventions:~Cycle 1: cytarabine, HPC-A donor infusion~Cycle 2: Participants who have at least a partial response to Cycle 1 are eligible to receive Cycle 2: cytarabine, HPC-A infusion~Cytarabine: Given by either intrathecal (IT) or intravenous (IV) route.~Intrathecal Triples: given IT.~HPC-A: Given IV."
31502|NCT02433366|B3|Baseline|Total|Total of all reporting groups
31503|NCT02433366|B2|Baseline|Patients|AF patients on treatment with Pradaxa®.
31504|NCT02433366|B1|Baseline|Physicians|Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
31505|NCT02433366|P2|Participant Flow|Patients|AF patients on treatment with Pradaxa®.
31506|NCT02433366|P1|Participant Flow|Physicians|Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
31507|NCT02433366|O2|Outcome|Patients|AF patients on treatment with Pradaxa®.
31508|NCT02433366|O1|Outcome|Physicians|Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
31509|NCT02433366|O2|Outcome|Patients|AF patients on treatment with Pradaxa®.
31510|NCT02433366|O1|Outcome|Physicians|Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
31511|NCT02433366|E2|Reported Event|Patients|AF patients on treatment with Pradaxa®.
31512|NCT02433366|E1|Reported Event|Physicians|Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
31513|NCT02433340|B5|Baseline|Total|Total of all reporting groups
31514|NCT02433340|B4|Baseline|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31515|NCT02433340|B3|Baseline|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31516|NCT02433340|B2|Baseline|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31517|NCT02433340|B1|Baseline|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31518|NCT02433340|P4|Participant Flow|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31519|NCT02433340|P3|Participant Flow|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31520|NCT02433340|P2|Participant Flow|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31521|NCT02433340|P1|Participant Flow|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind Adalimumab (ADA) 40 mg every other week (EOW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31522|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31523|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31524|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31525|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31526|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31527|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31528|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31529|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31530|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31531|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31532|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31535|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31536|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31537|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31538|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31539|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31540|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31541|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31542|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31543|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31544|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31545|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31546|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31547|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31548|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31549|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31550|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31551|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31552|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31553|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31554|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31555|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31556|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31557|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31558|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31559|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31560|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31561|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31562|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31563|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31564|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31565|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31566|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31567|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31568|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31569|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31570|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31571|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31572|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31573|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31574|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31575|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31576|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31577|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31578|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31579|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31580|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31581|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31582|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31583|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31584|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31585|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31586|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31587|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31588|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31589|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31590|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31591|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31592|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31593|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31594|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31595|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31596|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31597|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31598|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31599|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31600|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31601|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31602|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31603|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31604|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31605|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31606|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31607|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31608|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31609|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31610|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31611|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31612|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31613|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31614|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31615|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31616|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31617|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31618|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31619|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31620|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31621|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31622|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31623|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31624|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31625|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31626|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31627|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31628|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31629|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31630|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31631|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31632|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31633|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31634|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31635|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31636|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31637|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31638|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
39952|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
31639|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31640|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31641|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31642|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31643|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31644|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31645|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31646|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31647|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31648|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31649|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31650|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31651|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31652|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31653|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31654|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31655|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31656|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31657|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31658|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31659|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31660|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31661|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31662|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31663|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31664|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31665|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31666|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31667|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31668|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31669|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31670|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31671|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31672|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31673|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31674|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31675|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31676|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31677|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31678|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31679|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31680|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31681|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31682|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31683|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31684|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31685|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31686|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31687|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31688|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31689|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
39953|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
31690|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31691|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31692|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31693|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31694|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31695|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31696|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31697|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31698|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31699|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31700|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31701|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31702|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31703|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31704|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31705|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31706|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31707|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31708|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31709|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31710|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31711|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31712|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31713|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31714|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31715|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31716|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31717|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31718|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31719|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31720|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31721|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31722|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31723|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31724|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31725|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31726|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31727|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31728|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31729|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31730|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31731|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31732|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31733|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31734|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31735|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31736|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31737|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31738|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31739|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31740|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
39954|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
31741|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31742|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31743|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31744|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31745|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31746|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31747|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31748|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31749|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31750|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31751|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31752|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31753|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31754|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31755|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31756|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31757|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31758|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31759|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31760|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31761|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31762|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31763|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31764|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31765|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31766|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31767|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31768|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31769|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31770|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31771|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31772|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31773|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31774|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31775|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31776|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31777|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31778|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31779|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31780|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31781|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31782|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31783|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31784|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31785|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31786|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31787|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31788|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31789|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31790|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31791|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31792|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31793|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31794|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31795|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31796|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31797|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31798|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31799|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31800|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31801|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31802|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31803|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31804|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31805|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31806|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31807|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31808|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31809|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31810|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31811|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31812|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31813|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31814|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31815|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31816|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31817|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31818|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31819|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31820|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31821|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31822|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31823|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31824|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31825|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31826|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31827|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31828|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31829|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31830|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31831|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31832|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31833|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31834|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31835|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31836|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31837|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31838|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31839|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31840|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31841|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31842|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31843|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
39955|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
31844|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31845|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31846|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31847|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31848|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31849|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31850|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31851|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31852|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31853|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31854|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31855|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31856|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31857|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31858|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31859|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31860|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31861|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31862|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31863|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31864|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31865|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31866|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31867|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31868|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31869|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31870|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31871|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31872|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31873|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31874|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31875|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31876|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31877|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31878|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31879|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31880|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31881|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31882|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31883|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31884|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31885|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31886|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31887|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31888|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31889|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31890|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31891|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31892|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31893|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31894|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
39956|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
31895|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31896|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31897|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31898|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31899|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31900|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31901|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31902|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31903|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31904|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31905|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31906|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31907|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31908|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31909|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31910|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31911|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31912|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31913|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31914|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31915|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31916|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31917|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31918|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31919|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31920|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31921|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31922|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31923|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31924|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31925|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31926|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31927|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31928|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31929|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31930|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31931|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31932|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31933|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31934|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31935|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31936|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31937|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31938|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31939|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31940|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31941|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31942|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31943|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31944|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31945|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
39957|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
31946|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31947|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31948|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31949|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31950|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31951|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31952|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31953|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31954|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31955|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31956|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31957|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31958|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31959|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31960|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31961|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31962|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31963|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31964|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31965|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31966|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31967|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31968|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31969|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31970|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31971|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31972|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31973|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31974|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31975|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31976|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31977|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31978|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31979|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31980|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31981|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31982|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31983|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31984|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31985|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31986|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31987|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31988|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31989|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31990|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31991|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31992|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31993|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31994|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31995|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31996|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
31997|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
31998|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
31999|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32000|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32001|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32002|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32003|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32004|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32005|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32006|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32007|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32008|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32009|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32010|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32011|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32012|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32013|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32014|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32015|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32016|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32017|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32018|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32019|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32020|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32021|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32022|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32023|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32024|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32025|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32026|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32027|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32028|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32029|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32030|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32031|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32032|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32033|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32034|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32035|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32036|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32037|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32038|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32039|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32040|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32041|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32042|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32043|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32044|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32045|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32046|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32047|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32048|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
39958|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
32049|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32050|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32051|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32052|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32053|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32054|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32055|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32056|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32057|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32058|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32059|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32060|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32061|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32062|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32063|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32064|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32065|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32066|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32067|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32068|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32069|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32070|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32071|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32072|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32073|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32074|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32075|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32076|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32077|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32078|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32079|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32080|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32081|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32082|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32083|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32084|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32085|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32086|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32087|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32088|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32089|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32090|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32091|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32092|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32093|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32094|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32095|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32096|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32097|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32098|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32099|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
39959|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
32100|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32101|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32102|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32103|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32104|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32105|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32106|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32107|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32108|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32109|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32110|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32111|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32112|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32113|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32114|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32115|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32116|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32117|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32118|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32119|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32120|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32121|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32122|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32123|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32124|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32125|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32126|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32127|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32128|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32129|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32130|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32131|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32132|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32133|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32134|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32135|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32136|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32137|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32138|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32139|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32140|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32141|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32142|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32143|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32144|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32145|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32146|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32147|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32148|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32149|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32150|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
39960|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
32151|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32152|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32153|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32154|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32155|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32156|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32157|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32158|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32159|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32160|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32161|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32162|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32163|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32164|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32165|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32166|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32167|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32168|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32169|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32170|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32171|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32172|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32173|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32174|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32175|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32176|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32177|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32178|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32179|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32180|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32181|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32182|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32183|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32184|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32185|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32186|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32187|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32188|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32189|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32190|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32191|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32192|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32193|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32194|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32195|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32196|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32197|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32198|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32199|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32200|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32201|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32202|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32203|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32204|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32205|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32206|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32207|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32208|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32209|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32210|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32211|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32212|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32213|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32214|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32215|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32216|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32217|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32218|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32219|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32220|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32221|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32222|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32223|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32224|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32225|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32226|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32227|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32228|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32229|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32230|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32231|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32232|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32233|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32234|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32235|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32236|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32237|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32238|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32239|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32240|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32241|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32242|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32243|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32244|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32245|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32246|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32247|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32248|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32249|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32250|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32251|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32252|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32253|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
39961|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
32254|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32255|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32256|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32257|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32258|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32259|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32260|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32261|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32262|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32263|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32264|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32265|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32266|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32267|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32268|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32269|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32270|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32271|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32272|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32273|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32274|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32275|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32276|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32277|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32278|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32279|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32280|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32281|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32282|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32283|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32284|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32285|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32286|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32287|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32288|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32289|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32290|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32291|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32292|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32293|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32294|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32295|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32296|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32297|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32298|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32299|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32300|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32301|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32302|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32303|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32304|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
39962|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
32305|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32306|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32307|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32308|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32309|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32310|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32311|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32312|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32313|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32314|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32315|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32316|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32317|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32318|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32319|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32320|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32321|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32322|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32323|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32324|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32325|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32326|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32327|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32328|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32329|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32330|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32331|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32332|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32333|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32334|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32335|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32336|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32337|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32338|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32339|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32340|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32341|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32342|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32343|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32344|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32345|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32346|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32347|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32348|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32349|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32350|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32351|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32352|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32353|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32354|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32355|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
39963|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
32356|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32357|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32358|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32359|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32360|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32361|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32362|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32363|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32364|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32365|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32366|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32367|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32368|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32369|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32370|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32371|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32372|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32373|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32374|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32375|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32376|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32377|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32378|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32379|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32380|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32381|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32382|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32383|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32384|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32385|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32386|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32387|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32388|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32389|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32390|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32391|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32392|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32393|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32394|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32395|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32396|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32397|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32398|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32399|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32400|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32401|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32402|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32403|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32404|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32405|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32406|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32407|NCT02433340|E5|Reported Event|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
32408|NCT02433340|E4|Reported Event|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
32409|NCT02433340|E3|Reported Event|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32410|NCT02433340|E2|Reported Event|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32411|NCT02433340|E1|Reported Event|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
32412|NCT02432300|B1|Baseline|Treatment Group (Emotion Builder)|"The intervention was a web-based treatment program called the Emotion Builder that was delivered by a clinician research assistant individually to participants.~Emotion Builder: Total of 8 therapy sessions (60-90 minutes each) over approximately four (4) weeks (2 sessions a week). The objective of these sessions were to increase emotional awareness and labeling. Lessons included exercises designed to build emotional vocabulary, lessons to help differentiate emotions, activities to enhance attention to changes in body states associated with emotional responses (emotional arousal), and virtual videos simulating emotional scenarios for practicing lessons learned."
32413|NCT02432300|P1|Participant Flow|Treatment Group (Emotion Builder)|"The intervention was a web-based treatment program called the Emotion Builder that was delivered by a clinician research assistant individually to participants.~Emotion Builder: Total of 8 therapy sessions (60-90 minutes each) over approximately four (4) weeks (2 sessions a week). The objective of these sessions were to increase emotional awareness and labeling. Lessons included exercises designed to build emotional vocabulary, lessons to help differentiate emotions, activities to enhance attention to changes in body states associated with emotional responses (emotional arousal), and virtual videos simulating emotional scenarios for practicing lessons learned."
32414|NCT02432300|O1|Outcome|Treatment Group (Emotion Builder)|"The intervention was a web-based treatment program called the Emotion Builder that was delivered by a clinician research assistant individually to participants.~Emotion Builder: Total of 8 therapy sessions (60-90 minutes each) over approximately four (4) weeks (2 sessions a week). The objective of these sessions were to increase emotional awareness and labeling. Lessons included exercises designed to build emotional vocabulary, lessons to help differentiate emotions, activities to enhance attention to changes in body states associated with emotional responses (emotional arousal), and virtual videos simulating emotional scenarios for practicing lessons learned."
32415|NCT02432300|O1|Outcome|Treatment Group (Emotion Builder)|"The intervention was a web-based treatment program called the Emotion Builder that was delivered by a clinician research assistant individually to participants.~Emotion Builder: Total of 8 therapy sessions (60-90 minutes each) over approximately four (4) weeks (2 sessions a week). The objective of these sessions were to increase emotional awareness and labeling. Lessons included exercises designed to build emotional vocabulary, lessons to help differentiate emotions, activities to enhance attention to changes in body states associated with emotional responses (emotional arousal), and virtual videos simulating emotional scenarios for practicing lessons learned."
32416|NCT02432300|O1|Outcome|Treatment Group (Emotion Builder)|"The intervention was a web-based treatment program called the Emotion Builder that was delivered by a clinician research assistant individually to participants.~Emotion Builder: Total of 8 therapy sessions (60-90 minutes each) over approximately four (4) weeks (2 sessions a week). The objective of these sessions were to increase emotional awareness and labeling. Lessons included exercises designed to build emotional vocabulary, lessons to help differentiate emotions, activities to enhance attention to changes in body states associated with emotional responses (emotional arousal), and virtual videos simulating emotional scenarios for practicing lessons learned."
32417|NCT02432300|O1|Outcome|Treatment Group (Emotion Builder)|"The intervention was a web-based treatment program called the Emotion Builder that was delivered by a clinician research assistant individually to participants.~Emotion Builder: Total of 8 therapy sessions (60-90 minutes each) over approximately four (4) weeks (2 sessions a week). The objective of these sessions were to increase emotional awareness and labeling. Lessons included exercises designed to build emotional vocabulary, lessons to help differentiate emotions, activities to enhance attention to changes in body states associated with emotional responses (emotional arousal), and virtual videos simulating emotional scenarios for practicing lessons learned."
32418|NCT02432300|E1|Reported Event|Treatment Group (Emotion Builder)|8 sessions of a web-based treatment, each lasting 60-90 minutes, twice per week over 4 weeks with a clinician research assistant. This treatment aimed to improve emotional awareness and labeling.
32419|NCT02432287|B3|Baseline|Total|Total of all reporting groups
32420|NCT02432287|B2|Baseline|Placebo FIRST, Then Metformin|In the placebo first group, individuals took placebo capsules that matched metformin for 6 weeks, followed by 2 weeks of washout, and concluding with metformin 1700mg/day (in 2 doses) for 6 weeks.
32421|NCT02432287|B1|Baseline|Metformin FIRST, Then Placebo|"Metformin, an FDA approved first-line drug for the treatment of type 2 diabetes, has known beneficial effects on glucose metabolism.~In the metformin first group, individuals took 1700mg/day metformin in 2 doses for 6 weeks, followed by 2 weeks of washout, and concluding with placebo capsules that matched the metformin for 6 weeks."
32422|NCT02432287|P2|Participant Flow|Placebo First, Then Metformin|Participants in the placebo first group took 1-2 placebo capsules 2 x daily (which matched metformin capsules) for 6 weeks, followed by a 2 week washout period, concluding with 6 weeks of 1-2 metformin capsules 2x daily.
32423|NCT02432287|P1|Participant Flow|Metformin First, Then Placebo|"Metformin, an FDA approved first-line drug for the treatment of type 2 diabetes, has known beneficial effects on glucose metabolism.~Participants in the metformin first group took 1-2 metformin capsules 2 times daily for 6 weeks, followed by a 2 week washout period, concluding with 6 weeks of 1-2 placebo capsules (which matched metformin capsules) 2 x daily."
32424|NCT02432287|O2|Outcome|Placebo Treatment|During the placebo treatment, individuals took placebo capsules that matched metformin for 6 weeks.
32425|NCT02432287|O1|Outcome|Metformin Treatment|"Metformin, an FDA approved first-line drug for the treatment of type 2 diabetes, has known beneficial effects on glucose metabolism.~During metformin treatment, individuals took 1700mg/day metformin in 2 doses for 6 weeks."
32426|NCT02432287|O2|Outcome|Placebo Treatment|Participants took placebo that matched metformin for 6 weeks.
32466|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
32427|NCT02432287|O1|Outcome|Metformin Treatment|"Metformin, an FDA approved first-line drug for the treatment of type 2 diabetes, has known beneficial effects on glucose metabolism.~Participants took metformin (1700 mg/day) for 6 weeks, followed by a 2 week washout, concluding with placebo pills (that matched metformin) for 6 weeks."
32428|NCT02432287|E2|Reported Event|Placebo|All participants took placebo capsules 2 x daily for 6 weeks.
32429|NCT02432287|E1|Reported Event|Metformin|"Metformin, an FDA approved first-line drug for the treatment of type 2 diabetes, has known beneficial effects on glucose metabolism.~Participants took metformin capsules 2 times daily for 6 weeks."
32430|NCT02432105|B4|Baseline|Total|Total of all reporting groups
32431|NCT02432105|B3|Baseline|Tubes Only|Bilateral myringotomy and tympanostomy tube insertion
32432|NCT02432105|B2|Baseline|EXE844 3 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
32433|NCT02432105|B1|Baseline|EXE844 7 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 7 days after Tympanostomy Tube Insertion
32434|NCT02432105|P3|Participant Flow|Tubes Only|Bilateral myringotomy and tympanostomy tube insertion
32435|NCT02432105|P2|Participant Flow|EXE844 3 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
32436|NCT02432105|P1|Participant Flow|EXE844 7 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, twice daily (BID) in each ear for 7 days after Tympanostomy Tube Insertion
32437|NCT02432105|O3|Outcome|Tubes Only|Bilateral myringotomy and tympanostomy tube insertion
32438|NCT02432105|O2|Outcome|EXE844 3 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
32439|NCT02432105|O1|Outcome|EXE844 7 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 7 days after Tympanostomy Tube Insertion
32440|NCT02432105|O3|Outcome|Tubes Only|Bilateral myringotomy and tympanostomy tube insertion
32441|NCT02432105|O2|Outcome|EXE844 3 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
32442|NCT02432105|O1|Outcome|EXE844 7 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 7 days after Tympanostomy Tube Insertion
32443|NCT02432105|O3|Outcome|Tubes Only|Bilateral myringotomy and tympanostomy tube insertion
32444|NCT02432105|O2|Outcome|EXE844 3 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
32445|NCT02432105|O1|Outcome|EXE844 7 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 7 days after Tympanostomy Tube Insertion
32446|NCT02432105|E4|Reported Event|Tubes Only|All participants treated with bilateral myringotomy and tympanostomy tube insertion only
32447|NCT02432105|E3|Reported Event|EXE844 3 Days|All participants treated with EXE844 Sterile Otic Suspension, 0.3% for 3 days after Tympanostomy Tube Insertion
32448|NCT02432105|E2|Reported Event|EXE844 7 Days|All participants treated with EXE844 Sterile Otic Suspension, 0.3% for 7 days after Tympanostomy Tube Insertion
32449|NCT02432105|E1|Reported Event|Pretreatment|All AEs reported prior to randomization
32450|NCT02432040|B3|Baseline|Total|Total of all reporting groups
32451|NCT02432040|B2|Baseline|Placebo|Placebo tablets But patients are still asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
32452|NCT02432040|B1|Baseline|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
32453|NCT02432040|P2|Participant Flow|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
32454|NCT02432040|P1|Participant Flow|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
32455|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
32456|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
32457|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
32458|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
32459|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
32460|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
32461|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
32462|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
32463|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
32464|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
32465|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
34458|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
32467|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
32468|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
32469|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
32470|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
32471|NCT02432040|E2|Reported Event|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
32472|NCT02432040|E1|Reported Event|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
32473|NCT02431754|B3|Baseline|Total|Total of all reporting groups
32474|NCT02431754|B2|Baseline|Placebo/Tadalafil|"Placebo administered once daily orally for 8 weeks in one of two treatment periods.~5 mg tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
32475|NCT02431754|B1|Baseline|Tadalafil/Placebo|"5 milligrams (mg) tadalafil administered QD orally for 8 weeks in one of two treatment periods.~Placebo administered once daily orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
32476|NCT02431754|P2|Participant Flow|Placebo/Tadalafil|"Placebo administered orally QD for 8 weeks in one of two treatment periods.~5 mg tadalafil administered orally QD for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
32477|NCT02431754|P1|Participant Flow|Tadalafil/Placebo|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~Placebo administered once daily orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
32478|NCT02431754|O2|Outcome|Placebo|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
32479|NCT02431754|O1|Outcome|Tadalafil|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
32480|NCT02431754|O2|Outcome|Placebo|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
32481|NCT02431754|O1|Outcome|Tadalafil|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
32482|NCT02431754|O2|Outcome|Placebo|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
32483|NCT02431754|O1|Outcome|Tadalafil|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
32484|NCT02431754|O2|Outcome|Placebo|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
32485|NCT02431754|O1|Outcome|Tadalafil|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
32486|NCT02431754|O2|Outcome|Placebo|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
32487|NCT02431754|O1|Outcome|Tadalafil|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
32488|NCT02431754|O2|Outcome|Placebo|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
32489|NCT02431754|O1|Outcome|Tadalafil|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
32490|NCT02431754|O2|Outcome|Placebo/Tadalafil|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
32491|NCT02431754|O1|Outcome|Tadalafil/Placebo|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
32671|NCT02430389|E2|Reported Event|Normal Saline|"Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Placebo"
32492|NCT02431754|E2|Reported Event|Placebo|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
32493|NCT02431754|E1|Reported Event|Tadalafil|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
32494|NCT02431741|B1|Baseline|Mepilex Transfer Ag|"Non controlled investigation~Mepilex Transfer Ag"
32495|NCT02431741|P1|Participant Flow|Mepilex Transfer Ag|"Non controlled investigation~Mepilex Transfer Ag"
32496|NCT02431741|O1|Outcome|Mepilex Transfer Ag|"Non controlled investigation~Mepilex Transfer Ag"
32497|NCT02431741|E1|Reported Event|Mepilex Transfer Ag|"Non controlled investigation~Mepilex Transfer Ag"
32498|NCT02431598|B1|Baseline|Eovistvs vs. Dotarem vs. Saline|
32499|NCT02431598|P6|Participant Flow|Saline Crossover to Eovist Crossover to Dotarem|Subjects received the agents in this particular order during their MRI.
32500|NCT02431598|P5|Participant Flow|Dotarem Crossover to Saline Crossover to Eovist|Subjects received the agents in this particular order during their MRI.
32501|NCT02431598|P4|Participant Flow|Saline Crossover to Dotarem Crossover to Eovist|Subjects received the agents in this particular order during their MRI.
32502|NCT02431598|P3|Participant Flow|Eovist Crossover to Saline Crossover to Dotarem|Subjects received the agents in this particular order during their MRI.
32503|NCT02431598|P2|Participant Flow|Dotarem Crossover to Eovist Crossover to Saline|Subjects received the agents in this particular order during their MRI.
32504|NCT02431598|P1|Participant Flow|Eovist Crossover to Dotarem Crossover to Saline|Subjects received the agents in this particular order during their MRI.
32505|NCT02431598|O4|Outcome|Last Dynamic Phase|Imaging obtained during late dynamic phase
32506|NCT02431598|O3|Outcome|Portal Venous Phase|Imaging obtained during portal venous phase
32507|NCT02431598|O2|Outcome|Arterial Phase|Imaging obtained during arterial phase
32508|NCT02431598|O1|Outcome|Pre-Contrast Phase|Prior to contrast injection
32509|NCT02431598|O3|Outcome|Saline|Injection of normal saline
32510|NCT02431598|O2|Outcome|Dotarem (Gadoterate Dimeglumine)|Injection of gadoterate dimeglumine
32511|NCT02431598|O1|Outcome|Eovist (Gadoxetate Disodium)|Injection of gadoxetate disodium
32512|NCT02431598|O3|Outcome|Saline|Injection of normal saline
32513|NCT02431598|O2|Outcome|Dotarem (Gadoterate Dimeglumine)|Injection of gadoterate dimeglumine
32514|NCT02431598|O1|Outcome|Eovist (Gadoxetate Disodium)|Injection of gadoxetate disodium
32515|NCT02431598|O3|Outcome|Saline|Injection of normal saline
32516|NCT02431598|O2|Outcome|Dotarem (Gadoterate Dimeglumine)|Injection of gadoterate dimeglumine
32517|NCT02431598|O1|Outcome|Eovist (Gadoxetate Disodium)|Injection of gadoxetate disodium
32518|NCT02431598|O3|Outcome|Dotarem (Gadoterate Dimeglumine)|Injection of gadoterate dimeglumine
32519|NCT02431598|O2|Outcome|Saline|Injection of normal saline
32520|NCT02431598|O1|Outcome|Eovist (Gadoxetate Disodium)|Injection of gadoxetate disodium
32521|NCT02431598|O3|Outcome|Saline|
32522|NCT02431598|O2|Outcome|Dotarem (Gadoterate Dimeglumine)|
32523|NCT02431598|O1|Outcome|Eovist (Gadoxetate Disodium)|
32524|NCT02431598|E3|Reported Event|Saline|
32525|NCT02431598|E2|Reported Event|Dotarem (Gadoterate Dimeglumine)|
32526|NCT02431598|E1|Reported Event|Eovist (Gadoxetate Disodium)|
32527|NCT02431455|B3|Baseline|Total|Total of all reporting groups
32528|NCT02431455|B2|Baseline|No Incentive Spirometry|"No incentive spirometer provided~No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
32529|NCT02431455|B1|Baseline|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake~Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
32530|NCT02431455|P2|Participant Flow|No Incentive Spirometry|"No incentive spirometer provided~No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
32531|NCT02431455|P1|Participant Flow|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake~Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
32532|NCT02431455|O2|Outcome|No Incentive Spirometry|"No incentive spirometer provided~No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
32533|NCT02431455|O1|Outcome|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake~Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
32534|NCT02431455|O2|Outcome|No Incentive Spirometry|"No incentive spirometer provided~No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
32535|NCT02431455|O1|Outcome|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake~Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
32536|NCT02431455|O2|Outcome|No Incentive Spirometry|"No incentive spirometer provided~No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
32537|NCT02431455|O1|Outcome|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake~Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
32538|NCT02431455|O2|Outcome|No Incentive Spirometry|"No incentive spirometer provided~No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
32539|NCT02431455|O1|Outcome|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake~Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
32540|NCT02431455|E2|Reported Event|No Incentive Spirometry|"No incentive spirometer provided~No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
33262|NCT02422303|P2|Participant Flow|No Ketamine Group|This group will not receive ketamine at induction of general anesthesia.
32541|NCT02431455|E1|Reported Event|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake~Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
32542|NCT02431299|B3|Baseline|Total|Total of all reporting groups
32543|NCT02431299|B2|Baseline|IMR Clinicians|Clinicians who provided the IMR intervention to the IMR Consumers
32544|NCT02431299|B1|Baseline|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
32545|NCT02431299|P2|Participant Flow|IMR Clinicians|The clinicians who provided IMR intervention to the IMR Consumers
32546|NCT02431299|P1|Participant Flow|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
32547|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
32548|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
32549|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
32550|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
32551|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
32552|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
32553|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
32554|NCT02431299|O1|Outcome|IMR Clinicians|Clinicians providing IMR to the IMR consumers.
32555|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
32556|NCT02431299|E2|Reported Event|IMR Clinicians|Clinician participants who are providing Illness Management and Recovery (IMR) intervention.
32557|NCT02431299|E1|Reported Event|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
32558|NCT02430870|B9|Baseline|Total|Total of all reporting groups
32559|NCT02430870|B8|Baseline|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32560|NCT02430870|B7|Baseline|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32561|NCT02430870|B6|Baseline|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32562|NCT02430870|B5|Baseline|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32563|NCT02430870|B4|Baseline|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32564|NCT02430870|B3|Baseline|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32565|NCT02430870|B2|Baseline|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32566|NCT02430870|B1|Baseline|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32567|NCT02430870|P8|Participant Flow|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32568|NCT02430870|P7|Participant Flow|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32569|NCT02430870|P6|Participant Flow|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32570|NCT02430870|P5|Participant Flow|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32571|NCT02430870|P4|Participant Flow|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32572|NCT02430870|P3|Participant Flow|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32702|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32573|NCT02430870|P2|Participant Flow|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32574|NCT02430870|P1|Participant Flow|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32575|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32576|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32577|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32578|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32579|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32580|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32581|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32582|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32583|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32584|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32585|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32586|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32587|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32588|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32589|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32590|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32591|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32592|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32593|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32594|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32595|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32596|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32597|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32598|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32599|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32600|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32601|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32602|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32603|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32604|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32605|NCT02430870|O5|Outcome|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32606|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32607|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32608|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32609|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32610|NCT02430870|O3|Outcome|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32611|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32612|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32613|NCT02430870|O5|Outcome|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32614|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32615|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32616|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32617|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32618|NCT02430870|O3|Outcome|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
39964|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
32619|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32620|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32621|NCT02430870|O5|Outcome|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32622|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32623|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32624|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32625|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32626|NCT02430870|O3|Outcome|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32627|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32628|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32629|NCT02430870|O5|Outcome|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32630|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32631|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32632|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32633|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32634|NCT02430870|O3|Outcome|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32635|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32636|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32637|NCT02430870|E8|Reported Event|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32638|NCT02430870|E7|Reported Event|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32639|NCT02430870|E6|Reported Event|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32640|NCT02430870|E5|Reported Event|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32641|NCT02430870|E4|Reported Event|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
32642|NCT02430870|E3|Reported Event|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32643|NCT02430870|E2|Reported Event|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32644|NCT02430870|E1|Reported Event|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
32645|NCT02430532|B3|Baseline|Total|Total of all reporting groups
32646|NCT02430532|B2|Baseline|Tecfidera 240 mg BID|BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
32647|NCT02430532|B1|Baseline|Placebo|BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
32648|NCT02430532|P2|Participant Flow|Tecfidera 240 mg BID|BG00012 120 mg orally twice daily (BID) for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
32649|NCT02430532|P1|Participant Flow|Placebo|BG00012 120 mg capsule orally once a day (QD) supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
32650|NCT02430532|O2|Outcome|Tecfidera 240 mg BID|BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
32651|NCT02430532|O1|Outcome|Placebo|BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
32652|NCT02430532|O2|Outcome|Tecfidera 240 mg BID|BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
32653|NCT02430532|O1|Outcome|Placebo|BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
32654|NCT02430532|O2|Outcome|Tecfidera 240 mg BID|BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
32655|NCT02430532|O1|Outcome|Placebo|BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
32656|NCT02430532|O2|Outcome|Tecfidera 240 mg BID|BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
32657|NCT02430532|O1|Outcome|Placebo|BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
32658|NCT02430532|O2|Outcome|Tecfidera 240 mg BID|BG00012 120 mg orally twice daily (BID) for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
32659|NCT02430532|O1|Outcome|Placebo|BG00012 120 mg capsule orally once a day (QD) supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
32660|NCT02430532|E2|Reported Event|Tecfidera 240 mg BID|BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
32661|NCT02430532|E1|Reported Event|Placebo|BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
32662|NCT02430389|B3|Baseline|Total|Total of all reporting groups
32663|NCT02430389|B2|Baseline|Normal Saline|"Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Placebo"
32664|NCT02430389|B1|Baseline|Remifentanil|"Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning."
32665|NCT02430389|P2|Participant Flow|Normal Saline|"Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Placebo"
32666|NCT02430389|P1|Participant Flow|Remifentanil|"Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning."
32667|NCT02430389|O2|Outcome|Normal Saline|"Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Normal Saline: Ninety seconds before pinning, an IV bolus of 10 mL of normal saline will be administered from the study syringe and an IV bolus of propofol (0.7 mg•kg-1) will be administered"
32668|NCT02430389|O1|Outcome|Remifentanil|"Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Remifentanil: Ninety seconds before pinning, an IV bolus of 10 mL of remifentanil (0.7 µg•kg-1 based on ideal body weight) will be administered from the study syringe and an IV bolus of propofol (0.7 mg•kg-1) will be administered"
32669|NCT02430389|O2|Outcome|Normal Saline|"Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Placebo"
32670|NCT02430389|O1|Outcome|Remifentanil|"Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning."
32951|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
32672|NCT02430389|E1|Reported Event|Remifentanil|"Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning."
32673|NCT02430090|B4|Baseline|Total|Total of all reporting groups
32674|NCT02430090|B3|Baseline|Levobupivacaine + Sufentanil|"Sufentanil is a synthetic opioid analgesic. Sufentanil exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation.~Maintenance: Additional doses of 0.5-10 mcg/kg may be given if needed. Max (total dose): 30 mcg/kg. Post-op pain Initial: 30-60 mcg. Additional doses of up to 25 mcg may be given at intervals of ≥1 hr if needed. Epidural Pain relief during labour and delivery W/ bupivacaine: 10-15 mcg w/ or w/o epinephrine. May repeat dose twice at intervals of ≥1 hr till delivery. Max (total dose): 30 mcg.~Read more: http://www.ndrugs.com/?s=sufentanil#ixzz3XvqVyLzx~Sufentanil: this used in intratechal area and for spinal anesthesia in ceserean section~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
32675|NCT02430090|B2|Baseline|Levobupivacaine + Fentanyl|"Fentanyl - Used for: Producing anesthesia for surgery and treating pain before, during, and after surgery.Fentanyl is a narcotic (opioid) analgesic. It works in the brain and nervous system to cause anesthesia and decrease pain.~Indications:~Adult: PO Breakthrough cancer pain As a loz: Initially, 200 mcg over 15 minutes for an episode of breakthrough pain; may repeat once after 15 minutes if needed. Not more than 4 unit doses/day. IV Adjunct to general anesth Patients w/ spontaneous resp: Initial: 50-200 mcg, w/ supplements of 50 mcg. Patients w/ assisted ventilation: Initial: 300-3,500 mcg (up to 50 mcg/kg), w/ supplements of 100-200 mcg depending on response.~Read more: http://www.ndrugs.com/?s=fentanyl#ixzz3XvpAcULL~Fentanyl: this used in intratechal area and for spinal anesthesia in ceserean section~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
32676|NCT02430090|B1|Baseline|Levobupivacaine|"Levobupivacaine, a local anesthetic agent, is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures.~Injection Surgical anaesthesia~Adult: Epidural block: 50-100 mg (10-20 ml) of a 0.5% solution or 75-150 mg (10-20 ml) of a 0.75% solution. Caesarean section: 75-150 mg (15-30 ml) of a 0.5% solution. Spinal block: 15 mg (3 ml) of a 0.5% solution. Max: 150 mg/dose; 400 mg/day. Injection Peripheral nerve block~Read more: http://www.ndrugs.com/?s=levobupivacaine#ixzz3Xvp0iS5T~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
32677|NCT02430090|P3|Participant Flow|Levobupivacaine + Sufentanil|"Sufentanil is a synthetic opioid analgesic. Sufentanil exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation.~Maintenance: Additional doses of 0.5-10 mcg/kg may be given if needed. Max (total dose): 30 mcg/kg. Post-op pain Initial: 30-60 mcg. Additional doses of up to 25 mcg may be given at intervals of ≥1 hr if needed. Epidural Pain relief during labour and delivery W/ bupivacaine: 10-15 mcg w/ or w/o epinephrine. May repeat dose twice at intervals of ≥1 hr till delivery. Max (total dose): 30 mcg.~Read more: http://www.ndrugs.com/?s=sufentanil#ixzz3XvqVyLzx~Sufentanil: this used in intratechal area and for spinal anesthesia in ceserean section~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
32678|NCT02430090|P2|Participant Flow|Levobupivacaine + Fentanyl|"Fentanyl - Used for: Producing anesthesia for surgery and treating pain before, during, and after surgery.Fentanyl is a narcotic (opioid) analgesic. It works in the brain and nervous system to cause anesthesia and decrease pain.~Indications:~Adult: PO Breakthrough cancer pain As a loz: Initially, 200 mcg over 15 minutes for an episode of breakthrough pain; may repeat once after 15 minutes if needed. Not more than 4 unit doses/day. IV Adjunct to general anesth Patients w/ spontaneous resp: Initial: 50-200 mcg, w/ supplements of 50 mcg. Patients w/ assisted ventilation: Initial: 300-3,500 mcg (up to 50 mcg/kg), w/ supplements of 100-200 mcg depending on response.~Read more: http://www.ndrugs.com/?s=fentanyl#ixzz3XvpAcULL~Fentanyl: this used in intratechal area and for spinal anesthesia in ceserean section~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
32679|NCT02430090|P1|Participant Flow|Levobupivacaine|"Levobupivacaine, a local anesthetic agent, is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures.~Injection Surgical anaesthesia~Adult: Epidural block: 50-100 mg (10-20 ml) of a 0.5% solution or 75-150 mg (10-20 ml) of a 0.75% solution. Caesarean section: 75-150 mg (15-30 ml) of a 0.5% solution. Spinal block: 15 mg (3 ml) of a 0.5% solution. Max: 150 mg/dose; 400 mg/day. Injection Peripheral nerve block~Read more: http://www.ndrugs.com/?s=levobupivacaine#ixzz3Xvp0iS5T~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
32680|NCT02430090|O3|Outcome|Levobupivacaine + Sufentanil|2 ml of 0.5% levobupivacaine was added to 1 ml of 1,5 µcg sufentanil in group III by intrathecal administration
32681|NCT02430090|O2|Outcome|Levobupivacaine + Fentanyl|2 ml of 0.5% levobupivacaine was added to 1 ml of 15 µcg of fentanyl in group II by intrathecal administration
32682|NCT02430090|O1|Outcome|Levobupivacaine|2 ml of 0.5% levobupivacaine was added to 1 ml of saline in group I by intrathecal administration
32683|NCT02430090|E3|Reported Event|Levobupivacaine + Sufentanil|"Sufentanil is a synthetic opioid analgesic. Sufentanil exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation.~Maintenance: Additional doses of 0.5-10 mcg/kg may be given if needed. Max (total dose): 30 mcg/kg. Post-op pain Initial: 30-60 mcg. Additional doses of up to 25 mcg may be given at intervals of ≥1 hr if needed. Epidural Pain relief during labour and delivery W/ bupivacaine: 10-15 mcg w/ or w/o epinephrine. May repeat dose twice at intervals of ≥1 hr till delivery. Max (total dose): 30 mcg.~Read more: http://www.ndrugs.com/?s=sufentanil#ixzz3XvqVyLzx~Sufentanil: this used in intratechal area and for spinal anesthesia in ceserean section~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
32703|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
34459|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
32684|NCT02430090|E2|Reported Event|Levobupivacaine + Fentanyl|"Fentanyl - Used for: Producing anesthesia for surgery and treating pain before, during, and after surgery.Fentanyl is a narcotic (opioid) analgesic. It works in the brain and nervous system to cause anesthesia and decrease pain.~Indications:~Adult: PO Breakthrough cancer pain As a loz: Initially, 200 mcg over 15 minutes for an episode of breakthrough pain; may repeat once after 15 minutes if needed. Not more than 4 unit doses/day. IV Adjunct to general anesth Patients w/ spontaneous resp: Initial: 50-200 mcg, w/ supplements of 50 mcg. Patients w/ assisted ventilation: Initial: 300-3,500 mcg (up to 50 mcg/kg), w/ supplements of 100-200 mcg depending on response.~Read more: http://www.ndrugs.com/?s=fentanyl#ixzz3XvpAcULL~Fentanyl: this used in intratechal area and for spinal anesthesia in ceserean section~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
32685|NCT02430090|E1|Reported Event|Levobupivacaine|"Levobupivacaine, a local anesthetic agent, is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures.~Injection Surgical anaesthesia~Adult: Epidural block: 50-100 mg (10-20 ml) of a 0.5% solution or 75-150 mg (10-20 ml) of a 0.75% solution. Caesarean section: 75-150 mg (15-30 ml) of a 0.5% solution. Spinal block: 15 mg (3 ml) of a 0.5% solution. Max: 150 mg/dose; 400 mg/day. Injection Peripheral nerve block~Read more: http://www.ndrugs.com/?s=levobupivacaine#ixzz3Xvp0iS5T~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
32686|NCT02429791|B3|Baseline|Total|Total of all reporting groups
32687|NCT02429791|B2|Baseline|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32688|NCT02429791|B1|Baseline|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32689|NCT02429791|P2|Participant Flow|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32690|NCT02429791|P1|Participant Flow|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32691|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32692|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32693|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32694|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32695|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32696|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32697|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32698|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32699|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32700|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32701|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
35784|NCT02394756|O1|Outcome|Senofilcon A|Subjects wore the senofilcon A lens in any of the three periods during the study.
32704|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32705|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32706|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32707|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32708|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32709|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32710|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32711|NCT02429791|O2|Outcome|RPV 25 mg|Participants received DTG 50 mg + RPV 25 mg together once daily, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32712|NCT02429791|O1|Outcome|DTG 50 mg|Participants received DTG 50 mg + RPV 25 mg together once daily, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32713|NCT02429791|O2|Outcome|RPV 25 mg|Participants received DTG 50 mg + RPV 25 mg together once daily, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32714|NCT02429791|O1|Outcome|DTG 50 mg|Participants received DTG 50 mg + RPV 25 mg together once daily, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32715|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32716|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32717|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32718|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32719|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32720|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32721|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32722|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32723|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32724|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32725|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
35862|NCT02393950|O4|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10 mg ODM-106 Capsule B.
32726|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32727|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32728|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32729|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32730|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32731|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32732|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32733|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32734|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32735|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32736|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32737|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32738|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32739|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32740|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32741|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32742|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32743|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32744|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32745|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32952|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
32746|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32747|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32748|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32749|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32750|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32751|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32752|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32753|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32754|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32755|NCT02429791|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32756|NCT02429791|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32757|NCT02429791|E2|Reported Event|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
32758|NCT02429791|E1|Reported Event|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
32759|NCT02429258|B3|Baseline|Total|Total of all reporting groups
32760|NCT02429258|B2|Baseline|Placebo|Placebo + Metformin or Insulin
32761|NCT02429258|B1|Baseline|Dapagliflozin|Dapagliflozin + Metformin or Insulin
32762|NCT02429258|P2|Participant Flow|Placebo|Placebo + Metformin or Insulin
32763|NCT02429258|P1|Participant Flow|Dapagliflozin|Dapagliflozin + Metformin or Insulin
32764|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
32765|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
32766|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
32767|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
32768|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
32769|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
32770|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
32771|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
32772|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
32773|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
32774|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
32775|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
32776|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
32777|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
32778|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
32779|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
32780|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
32781|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
32782|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
32783|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
32784|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
32785|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
32786|NCT02429258|E2|Reported Event|Placebo|Placebo + Metformin or Insulin
32787|NCT02429258|E1|Reported Event|Dapagliflozin|Dapagliflozin + Metformin or Insulin
36036|NCT02392377|B3|Baseline|Total|Total of all reporting groups
32788|NCT02428478|B1|Baseline|All Analyzed Participants|All participants who were randomized, completed both study nights, and were included in the analysis. 4 participants were excluded: 3 due to intermittent electromyographic amplifier malfunction; and 1 did not sleep on both study nights.
32789|NCT02428478|P2|Participant Flow|Placebo First, Desipramine Second|Placebo-matching desipramine administered 2 hours before normal sleep time on first study night, then a 1-week non-treatment period, then desipramine administered 2 hours before normal sleep time on second study night.
32790|NCT02428478|P1|Participant Flow|Desipramine First, Placebo Second|Desipramine 200 mg administered 2 hours before normal sleep time on first study night, then a 1-week non-treatment period, then placebo-matching desipramine administered 2 hours before normal sleep time on second study night.
32791|NCT02428478|O2|Outcome|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
32792|NCT02428478|O1|Outcome|Desipramine|Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
32793|NCT02428478|O2|Outcome|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
32794|NCT02428478|O1|Outcome|Desipramine|Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
32795|NCT02428478|E2|Reported Event|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
32796|NCT02428478|E1|Reported Event|Desipramine|Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
32797|NCT02428413|B3|Baseline|Total|Total of all reporting groups
32798|NCT02428413|B2|Baseline|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.~ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
32799|NCT02428413|B1|Baseline|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen~Standard oxygen mask: Provide supplemental oxygen"
32800|NCT02428413|P2|Participant Flow|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.~ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
32801|NCT02428413|P1|Participant Flow|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen~Standard oxygen mask: Provide supplemental oxygen"
32802|NCT02428413|O2|Outcome|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.~ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
32803|NCT02428413|O1|Outcome|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen~Standard oxygen mask: Provide supplemental oxygen"
32804|NCT02428413|O2|Outcome|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.~ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
32805|NCT02428413|O1|Outcome|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen~Standard oxygen mask: Provide supplemental oxygen"
32806|NCT02428413|O2|Outcome|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.~ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
32807|NCT02428413|O1|Outcome|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen~Standard oxygen mask: Provide supplemental oxygen"
32808|NCT02428413|O2|Outcome|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.~ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
32809|NCT02428413|O1|Outcome|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen~Standard oxygen mask: Provide supplemental oxygen"
32810|NCT02428413|E2|Reported Event|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.~ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
32811|NCT02428413|E1|Reported Event|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen~Standard oxygen mask: Provide supplemental oxygen"
32812|NCT02428231|B3|Baseline|Total|Total of all reporting groups
32813|NCT02428231|B2|Baseline|Slow Up-Titration (Six-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
32814|NCT02428231|B1|Baseline|Standard Treatment (One-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
32815|NCT02428231|P2|Participant Flow|Slow Up-Titration (Six-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
32816|NCT02428231|P1|Participant Flow|Standard Treatment (One-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg dimethyl fumarate (DMF) twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
32817|NCT02428231|O2|Outcome|Slow Up-Titration (Six-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
32818|NCT02428231|O1|Outcome|Standard Treatment (One-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
32859|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
32819|NCT02428231|O2|Outcome|Slow Up-Titration (Six-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
32820|NCT02428231|O1|Outcome|Standard Treatment (One-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
32821|NCT02428231|O2|Outcome|Slow Up-Titration (Six-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
32822|NCT02428231|O1|Outcome|Standard Treatment (One-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
32823|NCT02428231|O2|Outcome|Slow Up-Titration (Six-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
32824|NCT02428231|O1|Outcome|Standard Treatment (One-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
32825|NCT02428231|O2|Outcome|Slow Up-Titration (Six-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
32826|NCT02428231|O1|Outcome|Standard Treatment (One-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
32827|NCT02428231|E2|Reported Event|6-Week Titration Arm|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
32828|NCT02428231|E1|Reported Event|Standard 1-Week Titration Arm|Following a 2-week placebo run-in baseline period, 120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
32829|NCT02427984|B4|Baseline|Total|Total of all reporting groups
32830|NCT02427984|B3|Baseline|Ceramic on Ceramic (CoC)|All the patients of our Division with CoC THA
32831|NCT02427984|B2|Baseline|Controls|All the patients of our Division for primary THA
32832|NCT02427984|B1|Baseline|Metal on Metal (MoM)|All the patients of our Division with MoM THA
32833|NCT02427984|P3|Participant Flow|Ceramic on Ceramic (CoC)|All the patients of our Division with CoC THA
32834|NCT02427984|P2|Participant Flow|Controls|
32835|NCT02427984|P1|Participant Flow|Metal on Metal (MoM)|All the patients of our Division with MoM THA
32836|NCT02427984|O1|Outcome|Metal on Metal (MoM)|
32837|NCT02427984|O2|Outcome|Metal on Metal (MoM)|
32838|NCT02427984|O1|Outcome|Ceramic on Ceramic (CoC)|
32839|NCT02427984|O2|Outcome|Metal on Metal (MoM)|
32840|NCT02427984|O1|Outcome|Ceramic on Ceramic (CoC)|
32841|NCT02427984|O2|Outcome|Metal on Metal (MoM)|
32842|NCT02427984|O1|Outcome|Ceramic on Ceramic (CoC)|
32843|NCT02427984|O2|Outcome|Control|
32844|NCT02427984|O1|Outcome|Metal on Metal (MoM)|
32845|NCT02427984|E3|Reported Event|Controls|
32846|NCT02427984|E2|Reported Event|Ceramic on Ceramic (CoC)|
32847|NCT02427984|E1|Reported Event|Metal on Metal (MoM)|
32848|NCT02427750|B3|Baseline|Total|Total of all reporting groups
32849|NCT02427750|B2|Baseline|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
32850|NCT02427750|B1|Baseline|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
32851|NCT02427750|P2|Participant Flow|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
32852|NCT02427750|P1|Participant Flow|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
32853|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
32854|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
32855|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
32856|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
32857|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
32858|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
36768|NCT02387554|B2|Baseline|Sequence 2|Period 1 : L Period 2 : C Period 3 : A Period 4 : ALC
32860|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
32861|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
32862|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
32863|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
32864|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
32865|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
32866|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
32867|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
32868|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
32869|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
32870|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
32871|NCT02427750|E3|Reported Event|Total|
32872|NCT02427750|E2|Reported Event|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
32873|NCT02427750|E1|Reported Event|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
32874|NCT02427477|B3|Baseline|Total|Total of all reporting groups
32875|NCT02427477|B2|Baseline|Delefilcon A / Senofilcon A / Delefilcon A|All subjects that randomized to receive this sequence and were dispensed a study lens.
32876|NCT02427477|B1|Baseline|Senofilcon A / Delefilcon A / Senofilcon A|All subjects that randomized to receive this sequence and were dispensed a study lens.
32877|NCT02427477|P2|Participant Flow|Delefilcon A / Senofilcon A / Delefilcon A|Subjects were randomly assigned to one of two lens sequences, over three lens wear periods. Subjects randomized to this sequence first wore delefilcon A contact lens, then wore the senofilcon A second and then wore the delefilcon A contact lens third.
32878|NCT02427477|P1|Participant Flow|Senofilcon A / Delefilcon A/ Senofilcon A|Subjects were randomly assigned to one of two lens sequences, over three lens wear periods. Subjects randomized to this sequence first wore the senofilcon A contact lens, then wore the delefilcon A contact lens second and then wore the senofilcon A contact lens third.
32879|NCT02427477|O2|Outcome|Delefilcon A|Subjects that received the delefilcon A contact lens in at least one of the three study periods.
32880|NCT02427477|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A contact lens in at least one of the three study periods.
32881|NCT02427477|O2|Outcome|Delefilcon A|Subjects that received the delefilcon A contact lens in at least one of the three study periods.
32882|NCT02427477|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A contact lens in at least one of the three study periods.
32883|NCT02427477|E2|Reported Event|Delefilcon A|Subjects that received the delefilcon A contact lens in at least one of the three study periods.
32884|NCT02427477|E1|Reported Event|Senofilcon A|Subjects that received the senofilcon A contact lens in at least one of the three study periods.
32885|NCT02427399|B6|Baseline|Total|Total of all reporting groups
32886|NCT02427399|B5|Baseline|Multimodal|"The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called. If a patient randomly selected for this group does not have an email listed, she will receive one letter and two phone calls.~Multimodal: The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called."
32887|NCT02427399|B4|Baseline|Phone|"The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. As per HIPAA regulations, if the patient does not answer, a voicemail will be left saying that a Fenway representative has called and request that the patient calls back, but a reason will not be given. Some, but not all of the information contained in the info sheet will be provided during the call (see phone script). The script used is consistent with the scripts used currently for patient outreach. A voicemail will still count as one outreach attempt out of three. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.~Phone: The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders."
32923|NCT02426541|O2|Outcome|Placebo|Placebo added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
32924|NCT02426541|O1|Outcome|Dapagliflozin 10 MG|Dapagliflozin 10 MG added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
32888|NCT02427399|B3|Baseline|Email|"The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders. The email will be sent from the provider’s email account. The email will have an informational sheet attached or included in the body of the email. The emails will be sent through MyFenway, the secure, Health Insurance Portability and Accountability Act (HIPAA)-compliant patient contact system at Fenway.~Email: The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders."
32889|NCT02427399|B2|Baseline|Letter and Informational Sheet|"The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests. If the patient does not contact Fenway within 1 month to schedule an appointment, an additional letter will be sent at 1 month, and similarly again at 2 months. These letters will be the same, except that letters two and three will mention that previous attempts have been made at contact. Based on best practices in the literature, the letters will be signed by the patient’s primary care provider.~Letter and informational sheet: The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests."
32890|NCT02427399|B1|Baseline|Usual Care / Opportunistic Screening|This group will not be contacted by the study team in any way and will receive the general standard of care at Fenway. Patient charts are reviewed by the provider and medical team shortly before a scheduled visit to determine if the patient is due for a Pap, and if so, the patient is offered a Pap during the visit or the chance to schedule one for another date. Any proactive outreach occurs infrequently and at an ad-hoc basis, but should any proactive outreach occur, the study team will not interfere.
32891|NCT02427399|P5|Participant Flow|Multimodal|"The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called. If a patient randomly selected for this group does not have an email listed, she will receive one letter and two phone calls.~Multimodal: The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called."
32892|NCT02427399|P4|Participant Flow|Phone|"The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. As per HIPAA regulations, if the patient does not answer, a voicemail will be left saying that a Fenway representative has called and request that the patient calls back, but a reason will not be given. Some, but not all of the information contained in the info sheet will be provided during the call (see phone script). The script used is consistent with the scripts used currently for patient outreach. A voicemail will still count as one outreach attempt out of three. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.~Phone: The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders."
32893|NCT02427399|P3|Participant Flow|Email|"The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders. The email will be sent from the provider’s email account. The email will have an informational sheet attached or included in the body of the email. The emails will be sent through MyFenway, the secure, Health Insurance Portability and Accountability Act (HIPAA)-compliant patient contact system at Fenway.~Email: The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders."
32894|NCT02427399|P2|Participant Flow|Letter and Informational Sheet|"The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests. If the patient does not contact Fenway within 1 month to schedule an appointment, an additional letter will be sent at 1 month, and similarly again at 2 months. These letters will be the same, except that letters two and three will mention that previous attempts have been made at contact. Based on best practices in the literature, the letters will be signed by the patient’s primary care provider.~Letter and informational sheet: The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests."
32895|NCT02427399|P1|Participant Flow|Usual Care / Opportunistic Screening|This group will not be contacted by the study team in any way and will receive the general standard of care at Fenway. Patient charts are reviewed by the provider and medical team shortly before a scheduled visit to determine if the patient is due for a Pap, and if so, the patient is offered a Pap during the visit or the chance to schedule one for another date. Any proactive outreach occurs infrequently and at an ad-hoc basis, but should any proactive outreach occur, the study team will not interfere.
32896|NCT02427399|O5|Outcome|Multimodal|"The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called. If a patient randomly selected for this group does not have an email listed, she will receive one letter and two phone calls.~Multimodal: The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called."
32897|NCT02427399|O4|Outcome|Phone|"The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. As per HIPAA regulations, if the patient does not answer, a voicemail will be left saying that a Fenway representative has called and request that the patient calls back, but a reason will not be given. Some, but not all of the information contained in the info sheet will be provided during the call (see phone script). The script used is consistent with the scripts used currently for patient outreach. A voicemail will still count as one outreach attempt out of three. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.~Phone: The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders."
36769|NCT02387554|B1|Baseline|Sequence 1|Period 1 : A Period 2 : L Period 3 : ALC Period 4 : C
32898|NCT02427399|O3|Outcome|Email|"The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders. The email will be sent from the provider’s email account. The email will have an informational sheet attached or included in the body of the email. The emails will be sent through MyFenway, the secure, Health Insurance Portability and Accountability Act (HIPAA)-compliant patient contact system at Fenway.~Email: The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders."
32899|NCT02427399|O2|Outcome|Letter and Informational Sheet|"The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests. If the patient does not contact Fenway within 1 month to schedule an appointment, an additional letter will be sent at 1 month, and similarly again at 2 months. These letters will be the same, except that letters two and three will mention that previous attempts have been made at contact. Based on best practices in the literature, the letters will be signed by the patient’s primary care provider.~Letter and informational sheet: The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests."
32900|NCT02427399|O1|Outcome|Usual Care / Opportunistic Screening|This group will not be contacted by the study team in any way and will receive the general standard of care at Fenway. Patient charts are reviewed by the provider and medical team shortly before a scheduled visit to determine if the patient is due for a Pap, and if so, the patient is offered a Pap during the visit or the chance to schedule one for another date. Any proactive outreach occurs infrequently and at an ad-hoc basis, but should any proactive outreach occur, the study team will not interfere.
32901|NCT02427399|O5|Outcome|Multimodal|"The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called. If a patient randomly selected for this group does not have an email listed, she will receive one letter and two phone calls.~Multimodal: The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called."
32902|NCT02427399|O4|Outcome|Phone|"The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. As per HIPAA regulations, if the patient does not answer, a voicemail will be left saying that a Fenway representative has called and request that the patient calls back, but a reason will not be given. Some, but not all of the information contained in the info sheet will be provided during the call (see phone script). The script used is consistent with the scripts used currently for patient outreach. A voicemail will still count as one outreach attempt out of three. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.~Phone: The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders."
32903|NCT02427399|O3|Outcome|Email|"The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders. The email will be sent from the provider’s email account. The email will have an informational sheet attached or included in the body of the email. The emails will be sent through MyFenway, the secure, Health Insurance Portability and Accountability Act (HIPAA)-compliant patient contact system at Fenway.~Email: The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders."
32904|NCT02427399|O2|Outcome|Letter and Informational Sheet|"The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests. If the patient does not contact Fenway within 1 month to schedule an appointment, an additional letter will be sent at 1 month, and similarly again at 2 months. These letters will be the same, except that letters two and three will mention that previous attempts have been made at contact. Based on best practices in the literature, the letters will be signed by the patient’s primary care provider.~Letter and informational sheet: The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests."
32905|NCT02427399|O1|Outcome|Usual Care / Opportunistic Screening|This group will not be contacted by the study team in any way and will receive the general standard of care at Fenway. Patient charts are reviewed by the provider and medical team shortly before a scheduled visit to determine if the patient is due for a Pap, and if so, the patient is offered a Pap during the visit or the chance to schedule one for another date. Any proactive outreach occurs infrequently and at an ad-hoc basis, but should any proactive outreach occur, the study team will not interfere.
32906|NCT02427399|O5|Outcome|Multimodal|"The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called. If a patient randomly selected for this group does not have an email listed, she will receive one letter and two phone calls.~Multimodal: The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called."
32907|NCT02427399|O4|Outcome|Phone|"The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. As per HIPAA regulations, if the patient does not answer, a voicemail will be left saying that a Fenway representative has called and request that the patient calls back, but a reason will not be given. Some, but not all of the information contained in the info sheet will be provided during the call (see phone script). The script used is consistent with the scripts used currently for patient outreach. A voicemail will still count as one outreach attempt out of three. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.~Phone: The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders."
33108|NCT02423577|O1|Outcome|FF-3 Dry Powder|"FF-3~FF-3 dry powder: FF-3 dry powder administered by nasal inhalation"
32908|NCT02427399|O3|Outcome|Email|"The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders. The email will be sent from the provider’s email account. The email will have an informational sheet attached or included in the body of the email. The emails will be sent through MyFenway, the secure, Health Insurance Portability and Accountability Act (HIPAA)-compliant patient contact system at Fenway.~Email: The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders."
32909|NCT02427399|O2|Outcome|Letter and Informational Sheet|"The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests. If the patient does not contact Fenway within 1 month to schedule an appointment, an additional letter will be sent at 1 month, and similarly again at 2 months. These letters will be the same, except that letters two and three will mention that previous attempts have been made at contact. Based on best practices in the literature, the letters will be signed by the patient’s primary care provider.~Letter and informational sheet: The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests."
32910|NCT02427399|O1|Outcome|Usual Care / Opportunistic Screening|This group will not be contacted by the study team in any way and will receive the general standard of care at Fenway. Patient charts are reviewed by the provider and medical team shortly before a scheduled visit to determine if the patient is due for a Pap, and if so, the patient is offered a Pap during the visit or the chance to schedule one for another date. Any proactive outreach occurs infrequently and at an ad-hoc basis, but should any proactive outreach occur, the study team will not interfere.
32911|NCT02427399|E5|Reported Event|Multimodal|"The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called. If a patient randomly selected for this group does not have an email listed, she will receive one letter and two phone calls.~Multimodal: The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called."
32912|NCT02427399|E4|Reported Event|Phone|"The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. As per HIPAA regulations, if the patient does not answer, a voicemail will be left saying that a Fenway representative has called and request that the patient calls back, but a reason will not be given. Some, but not all of the information contained in the info sheet will be provided during the call (see phone script). The script used is consistent with the scripts used currently for patient outreach. A voicemail will still count as one outreach attempt out of three. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.~Phone: The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders."
32913|NCT02427399|E3|Reported Event|Email|"The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders. The email will be sent from the provider’s email account. The email will have an informational sheet attached or included in the body of the email. The emails will be sent through MyFenway, the secure, Health Insurance Portability and Accountability Act (HIPAA)-compliant patient contact system at Fenway.~Email: The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders."
32914|NCT02427399|E2|Reported Event|Letter and Informational Sheet|"The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests. If the patient does not contact Fenway within 1 month to schedule an appointment, an additional letter will be sent at 1 month, and similarly again at 2 months. These letters will be the same, except that letters two and three will mention that previous attempts have been made at contact. Based on best practices in the literature, the letters will be signed by the patient’s primary care provider.~Letter and informational sheet: The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests."
32915|NCT02427399|E1|Reported Event|Usual Care / Opportunistic Screening|This group will not be contacted by the study team in any way and will receive the general standard of care at Fenway. Patient charts are reviewed by the provider and medical team shortly before a scheduled visit to determine if the patient is due for a Pap, and if so, the patient is offered a Pap during the visit or the chance to schedule one for another date. Any proactive outreach occurs infrequently and at an ad-hoc basis, but should any proactive outreach occur, the study team will not interfere.
32916|NCT02426541|B3|Baseline|Total|Total of all reporting groups
32917|NCT02426541|B2|Baseline|Placebo|Placebo added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
32918|NCT02426541|B1|Baseline|Dapagliflozin 10 MG|Dapagliflozin 10 MG added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
32919|NCT02426541|P2|Participant Flow|Placebo|Placebo added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
32920|NCT02426541|P1|Participant Flow|Dapagliflozin 10 MG|Dapagliflozin 10 MG added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
32921|NCT02426541|O2|Outcome|Placebo|Placebo added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
32922|NCT02426541|O1|Outcome|Dapagliflozin 10 MG|Dapagliflozin 10 MG added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
39965|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
32925|NCT02426541|O2|Outcome|Placebo|Placebo added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
32926|NCT02426541|O1|Outcome|Dapagliflozin 10 MG|Dapagliflozin 10 MG added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
32927|NCT02426541|E2|Reported Event|Placebo|Placebo added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
32928|NCT02426541|E1|Reported Event|Dapagliflozin 10 MG|Dapagliflozin 10 MG added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
32929|NCT02425956|B1|Baseline|MRI Imaging of Liver|"GE Optima/Discovery® MRI imaging data of the liver and surrounding tissues will be acquired using 1.5T and 3.0T GE Healthcare (GEHC) IDEAL IQ scans and commercially available 1.5T MRI scans conducted according to the FerriScan®~GE Optima/Discovery® MRI data of the liver: GE Optima 1.5T®/Discovery 3.0T® MRI data scanning data of the liver and surrounding tissues will be acquired using both field strengths for GE IDEAL IQ® and single field strength with FerriScan® (Resondence Health) Specialized Reconstruction Service, according instructions provided by manufacturer"
32930|NCT02425956|P1|Participant Flow|MRI Imaging of Liver|"GE Optima/Discovery® MRI imaging data of the liver and surrounding tissues will be acquired using 1.5T and 3.0T GE Healthcare (GEHC) IDEAL IQ scans and commercially available 1.5T MRI scans conducted according to the FerriScan®~GE Optima/Discovery® MRI data of the liver: GE Optima 1.5T®/Discovery 3.0T® MRI data scanning data of the liver and surrounding tissues will be acquired using both field strengths for GE IDEAL IQ® and single field strength with FerriScan® (Resondence Health) Specialized Reconstruction Service, according instructions provided by manufacturer"
32931|NCT02425956|O1|Outcome|MRI Imaging of Liver|"GE Optima/Discovery® MRI imaging data of the liver and surrounding tissues will be acquired using 1.5T and 3.0T GE Healthcare (GEHC) IDEAL IQ scans and commercially available 1.5T MRI scans conducted according to the FerriScan®~GE Optima/Discovery® MRI data of the liver: GE Optima 1.5T®/Discovery 3.0T® MRI data scanning data of the liver and surrounding tissues will be acquired using both field strengths for GE IDEAL IQ® and single field strength with FerriScan® (Resondence Health) Specialized Reconstruction Service, according instructions provided by manufacturer"
32932|NCT02425956|O1|Outcome|MRI Imaging of Liver|"GE Optima/Discovery® MRI imaging data of the liver and surrounding tissues will be acquired using 1.5T and 3.0T GE Healthcare (GEHC) IDEAL IQ scans and commercially available 1.5T MRI scans conducted according to the FerriScan®~GE Optima/Discovery® MRI data of the liver: GE Optima 1.5T®/Discovery 3.0T® MRI data scanning data of the liver and surrounding tissues will be acquired using both field strengths for GE IDEAL IQ® and single field strength with FerriScan® (Resondence Health) Specialized Reconstruction Service, according instructions provided by manufacturer"
32933|NCT02425956|E1|Reported Event|MRI Imaging of Liver|"GE Optima/Discovery® MRI imaging data of the liver and surrounding tissues will be acquired using 1.5T and 3.0T GE Healthcare (GEHC) IDEAL IQ scans and commercially available 1.5T MRI scans conducted according to the FerriScan®~GE Optima/Discovery® MRI data of the liver: GE Optima 1.5T®/Discovery 3.0T® MRI data scanning data of the liver and surrounding tissues will be acquired using both field strengths for GE IDEAL IQ® and single field strength with FerriScan® (Resondence Health) Specialized Reconstruction Service, according instructions provided by manufacturer"
32934|NCT02425826|B3|Baseline|Total|Total of all reporting groups
32935|NCT02425826|B2|Baseline|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
32936|NCT02425826|B1|Baseline|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
32937|NCT02425826|P3|Participant Flow|Placebo-Apremilast|Participants who were initially randomized to receive placebo were switched to apremilast 30 mg PO BID beginning at Week 16, for an additional 36 weeks (52 weeks total).
32938|NCT02425826|P2|Participant Flow|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice a day (BID) during the placebo-controlled phase (Weeks 0-16)
32939|NCT02425826|P1|Participant Flow|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
32940|NCT02425826|O1|Outcome|Apremilast|Participants treated with placebo initially, completed Week 16, entered and treated with apremilast during the apremilast open-label extension phase.
32941|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
32942|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
32943|NCT02425826|O1|Outcome|Apremilast|Apremilast 30 mg tablets orally twice daily (BID) weeks 0 to 52.
32944|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
32945|NCT02425826|O1|Outcome|Placebo-Apremilast|Participants who were initially randomized to receive placebo were switched to apremilast 30 mg PO BID beginning at Week 16, for an additional 36 weeks (52 weeks total).
32946|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
32947|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
32948|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
32949|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
32950|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
33109|NCT02423577|E2|Reported Event|Placebo|Placebo: Placebo dry powder administered by nasal inhalation
32953|NCT02425826|O1|Outcome|Placebo-Apremilast|Participants who were initially randomized to receive placebo were switched to apremilast 30 mg PO BID beginning at Week 16, for an additional 36 weeks (52 weeks total).
32954|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
32955|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
32956|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
32957|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
32958|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
32959|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
32960|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
32961|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
32962|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
32963|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
32964|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
32965|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
32966|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
32967|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
32968|NCT02425826|E3|Reported Event|Extension Phase: APR/APR and Placebo/APR (Weeks 0-52)|Includes participants initially randomized to apremilast tablets BID in the placebo controlled phase and continued on apremilast (Apremilast/Apremilast), as well as those who were initially randomized to placebo and switched at week 16 (Placebo/Apremilast) to Apremilast 30 mg tablets BID during weeks 16-52
32969|NCT02425826|E2|Reported Event|Placebo-Controlled Phase: Placebo (Weeks 0-16)|Participants initially randomized to identically matching placebo tablets PO BID during the placebo-controlled phase. (Weeks 0-16).
32970|NCT02425826|E1|Reported Event|Placebo-Controlled Phase: Apremilast (Weeks 0-16)|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
32971|NCT02425449|B6|Baseline|Total|Total of all reporting groups
32972|NCT02425449|B5|Baseline|Arm 5|"0.3 mg/kg succinylcholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
32973|NCT02425449|B4|Baseline|Arm 4|"0.25 mg/kg succinylcholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
32974|NCT02425449|B3|Baseline|Arm 3|"0.2 mg/kg of succinylcholne arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
32975|NCT02425449|B2|Baseline|Arm 2|"0.15 mg/kg of succinycholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
32976|NCT02425449|B1|Baseline|Arm 1|"0.1 mg/kg of succinylcholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
32977|NCT02425449|P5|Participant Flow|Arm 5|"0.3 mg/kg succinylcholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
32978|NCT02425449|P4|Participant Flow|Arm 4|"0.25 mg/kg succinylcholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
32979|NCT02425449|P3|Participant Flow|Arm 3|"0.2 mg/kg of succinylcholne arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
32980|NCT02425449|P2|Participant Flow|Arm 2|"0.15 mg/kg of succinycholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
32981|NCT02425449|P1|Participant Flow|Arm 1|"0.1 mg/kg of succinylcholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
32982|NCT02425449|O5|Outcome|Arm 5|"0.3 mg/kg succinylcholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
32983|NCT02425449|O4|Outcome|Arm 4|"0.25 mg/kg succinylcholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
32984|NCT02425449|O3|Outcome|Arm 3|"0.2 mg/kg of succinylcholne arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
32985|NCT02425449|O2|Outcome|Arm 2|"0.15 mg/kg of succinycholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
39966|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
32986|NCT02425449|O1|Outcome|Arm 1|"0.1 mg/kg of succinylcholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
32987|NCT02425449|E5|Reported Event|Arm 5|"0.3 mg/kg succinylcholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
32988|NCT02425449|E4|Reported Event|Arm 4|"0.25 mg/kg succinylcholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
32989|NCT02425449|E3|Reported Event|Arm 3|"0.2 mg/kg of succinylcholne arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
32990|NCT02425449|E2|Reported Event|Arm 2|"0.15 mg/kg of succinycholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
32991|NCT02425449|E1|Reported Event|Arm 1|"0.1 mg/kg of succinylcholine arm~Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5."
32992|NCT02424591|B3|Baseline|Total|Total of all reporting groups
32993|NCT02424591|B2|Baseline|Placebo|"placebo group will have standard of care rather than ketamine infusion~Placebo: Placebo IV"
32994|NCT02424591|B1|Baseline|Ketamine|"ketamine group will be infused after intubation and terminated at the start of skin closure~Ketamine: Infusion at a rate of 10 mcg/kg/min"
32995|NCT02424591|P2|Participant Flow|Placebo|"placebo group will have standard of care rather than ketamine infusion~Placebo: Placebo IV"
32996|NCT02424591|P1|Participant Flow|Ketamine|"ketamine group will be infused after intubation and terminated at the start of skin closure~Ketamine: Infusion at a rate of 10 mcg/kg/min"
32997|NCT02424591|O2|Outcome|Placebo|"placebo group will have standard of care rather than ketamine infusion~Placebo: Placebo IV"
32998|NCT02424591|O1|Outcome|Ketamine|"ketamine group will be infused after intubation and terminated at the start of skin closure~Ketamine: Infusion at a rate of 10 mcg/kg/min"
32999|NCT02424591|O2|Outcome|Placebo|"placebo group will have standard of care rather than ketamine infusion~Placebo: Placebo IV"
33000|NCT02424591|O1|Outcome|Ketamine|"ketamine group will be infused after intubation and terminated at the start of skin closure~Ketamine: Infusion at a rate of 10 mcg/kg/min"
33001|NCT02424591|O2|Outcome|Placebo|"placebo group will have standard of care rather than ketamine infusion~Placebo: Placebo IV"
33002|NCT02424591|O1|Outcome|Ketamine|"ketamine group will be infused after intubation and terminated at the start of skin closure~Ketamine: Infusion at a rate of 10 mcg/kg/min"
33003|NCT02424591|E2|Reported Event|Placebo|"placebo group will have standard of care rather than ketamine infusion~Placebo: Placebo IV"
33004|NCT02424591|E1|Reported Event|Ketamine|"ketamine group will be infused after intubation and terminated at the start of skin closure~Ketamine: Infusion at a rate of 10 mcg/kg/min"
33005|NCT02424578|B3|Baseline|Total|Total of all reporting groups
33006|NCT02424578|B2|Baseline|Diclofenac Capsules High Dose|"Diclofenac Capsules high dose three times daily for up to three days~Diclofenac Capsules high dose"
33007|NCT02424578|B1|Baseline|Diclofenac Capsules Low Dose|"Diclofenac Capsules low dose three times daily for up to three days~Diclofenac Capsules low dose"
33008|NCT02424578|P2|Participant Flow|Diclofenac Capsules High Dose|"Diclofenac Capsules high dose three times daily for up to three days~Diclofenac Capsules high dose"
33009|NCT02424578|P1|Participant Flow|Diclofenac Capsules Low Dose|"Diclofenac Capsules low dose three times daily for up to three days~Diclofenac Capsules low dose"
33010|NCT02424578|O2|Outcome|Diclofenac Capsules High Dose|"Diclofenac Capsules high dose three times daily for up to three days~Diclofenac Capsules high dose"
33011|NCT02424578|O1|Outcome|Diclofenac Capsules Low Dose|"Diclofenac Capsules low dose three times daily for up to three days~Diclofenac Capsules low dose"
33012|NCT02424578|E2|Reported Event|Diclofenac Capsules High Dose|"Diclofenac Capsules high dose three times daily for up to three days~Diclofenac Capsules high dose"
33013|NCT02424578|E1|Reported Event|Diclofenac Capsules Low Dose|"Diclofenac Capsules low dose three times daily for up to three days~Diclofenac Capsules low dose"
33014|NCT02424565|B1|Baseline|Overall Participants|Total number of participants randomized and treated in the study.
33015|NCT02424565|P2|Participant Flow|First Placebo Balm Then Test Balm|2 ± 0.2 g of placebo balm of 9g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint, then a gap of 3 days as a washout period, followed by application of 2 ± 0.2 g of test balm of 9g balm packed in each primary package .
33016|NCT02424565|P1|Participant Flow|First Test Balm Then Placebo Balm|2 ± 0.2 g of test balm of 9g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint, then a gap of 3 days as a washout period, followed by application of 2 ± 0.2 g of placebo balm of 9g balm packed in each primary package .
33017|NCT02424565|O2|Outcome|Placebo Balm|2 ± 0.2 g of placebo balm of 9 g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint.
33018|NCT02424565|O1|Outcome|Test Balm|2 ± 0.2 g of test balm of 9 g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint.
33019|NCT02424565|E2|Reported Event|Placebo Balm|2 ± 0.2 g of placebo balm of 9g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint.
33020|NCT02424565|E1|Reported Event|Test Balm|2 ± 0.2 g of test balm of 9 g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint.
33021|NCT02424357|B3|Baseline|Total|Total of all reporting groups
33022|NCT02424357|B2|Baseline|no Povidone-iodine Ophthalmic Solution|patient received a routine antibiotic/steroid ointment to operated eye at surgery completion
33023|NCT02424357|B1|Baseline|5% Povidone Iodine Ophthalmic Solution|patient received 1 drop of 5% povidone-iodine instilled over the adjustable suture noose in addition to routine antibiotic/steroid ointment to operated eye at surgery completion
33024|NCT02424357|P2|Participant Flow|no Povidone-iodine Ophthalmic Solution|patient received a routine antibiotic/steroid ointment to operated eye at surgery completion
33025|NCT02424357|P1|Participant Flow|5% Povidone Iodine Ophthalmic Solution|patient received 1 drop of 5% povidone-iodine instilled over the adjustable suture noose in addition to routine antibiotic/steroid ointment to operated eye at surgery completion
33026|NCT02424357|O1|Outcome|With or Without 5% Povidone Iodine Ophthalmic Solution|patients who received 1 drop of 5% povidone-iodine instilled over the adjustable suture noose in addition to routine antibiotic/steroid ointment to operated eye at surgery completion and those that did not receive povidone-iodine
33027|NCT02424357|O1|Outcome|With or Without 5% Povidone Iodine Ophthalmic Solution|patients with and without 1 drop of 5% povidone-iodine instilled over the adjustable suture noose in addition to routine antibiotic/steroid ointment to operated eye at surgery completion
33028|NCT02424357|O2|Outcome|no Povidone-iodine Ophthalmic Solution|patient received a routine antibiotic/steroid ointment to operated eye at surgery completion
33029|NCT02424357|O1|Outcome|5% Povidone Iodine Ophthalmic Solution|patient received 1 drop of 5% povidone-iodine instilled over the adjustable suture noose in addition to routine antibiotic/steroid ointment to operated eye at surgery completion
33030|NCT02424357|E2|Reported Event|no Povidone-iodine Ophthalmic Solution|patient received a routine antibiotic/steroid ointment to operated eye at surgery completion
33031|NCT02424357|E1|Reported Event|5% Povidone Iodine Ophthalmic Solution|patient received 1 drop of 5% povidone-iodine instilled over the adjustable suture noose in addition to routine antibiotic/steroid ointment to operated eye at surgery completion
33032|NCT02424149|B3|Baseline|Total|Total of all reporting groups
33033|NCT02424149|B2|Baseline|Phenazopyridine|Preoperative phenazopyridine
33034|NCT02424149|B1|Baseline|Control|No preoperative phenazopyridine
33035|NCT02424149|P2|Participant Flow|Phenazopyridine|Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
33036|NCT02424149|P1|Participant Flow|Control|No preoperative phenazopyridine
33037|NCT02424149|O2|Outcome|Phenazopyridine|Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
33038|NCT02424149|O1|Outcome|Control|No preoperative phenazopyridine
33039|NCT02424149|O2|Outcome|Phenazopyridine|Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
33040|NCT02424149|O1|Outcome|Control|No preoperative phenazopyridine
33041|NCT02424149|O2|Outcome|Phenazopyridine|Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
33042|NCT02424149|O1|Outcome|Control|No preoperative phenazopyridine
33043|NCT02424149|O2|Outcome|Phenazopyridine|Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
33044|NCT02424149|O1|Outcome|Control|No preoperative phenazopyridine
33045|NCT02424149|O2|Outcome|Phenazopyridine|Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
33046|NCT02424149|O1|Outcome|Control|No preoperative phenazopyridine
33047|NCT02424149|E2|Reported Event|Phenazopyridine|Preoperative phenazopyridine
33048|NCT02424149|E1|Reported Event|Control|No preoperative phenazopyridine
33049|NCT02423993|B5|Baseline|Total|Total of all reporting groups
33050|NCT02423993|B4|Baseline|CSII + Standart Education|Patients will be transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group should be educated about basic aspects of diabetes self-management at the School of Diabetes at least once earlier. Quality of Life (QoL) will be assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes will be assessed by HbA1c. The frequency of blood glucose self-monitoring will be estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency will be assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes will be used.
33051|NCT02423993|B3|Baseline|CSII + Group Education|"Patients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life will be assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes will be assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring will be estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency will be assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes will be used.~We will estimate metabolic and QoL parameters in 4 months after education and transferring to CSII."
33052|NCT02423993|B2|Baseline|SAP + Standart Education|Patients will be transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM will be used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 month. All patients from this group should be educated about basic aspects of diabetes self-management at the School of Diabetes at least once earlier. Quality of Life (QoL) will be assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes will be assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring will be estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency will be assessed by reports received
33110|NCT02423577|E1|Reported Event|FF-3 Dry Powder|"FF-3~FF-3 dry powder: FF-3 dry powder administered by nasal inhalation"
33111|NCT02423447|B1|Baseline|All Study Participants|"Electro-Flo Intervention: An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines.~G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines."
33127|NCT02423408|B2|Baseline|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~Placebo: Placebo capsule"
37221|NCT02379637|E1|Reported Event|A N-acetylcysteine|"N-acetylcysteine~N-acetylcysteine"
33053|NCT02423993|B1|Baseline|SAP + Group Education|"All patients will be transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life will be assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes will be assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring will be estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency will be assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes will be used.~We will estimate metabolic and QoL parameters in 4 months after education and transferring to CSII."
33054|NCT02423993|P4|Participant Flow|CSII + Standart Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
33055|NCT02423993|P3|Participant Flow|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
33056|NCT02423993|P2|Participant Flow|SAP + Standart Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
33057|NCT02423993|P1|Participant Flow|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
33058|NCT02423993|O4|Outcome|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
33059|NCT02423993|O3|Outcome|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
33112|NCT02423447|P2|Participant Flow|G5, Then Electro-Flo|"The patients were randomized to a series of airway clearance sessions with G5 on Day 1 and Electro-Flo on Day 2.~G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines"
33113|NCT02423447|P1|Participant Flow|Electro-Flo, Then G5|"The patients were randomized to a series of airway clearance sessions with Electro-Flo on Day 1 and G5 on Day 2.~Electro-Flo Intervention: An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines"
33060|NCT02423993|O2|Outcome|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
33061|NCT02423993|O1|Outcome|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
33062|NCT02423993|O4|Outcome|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
33063|NCT02423993|O3|Outcome|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
33064|NCT02423993|O2|Outcome|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
33065|NCT02423993|O1|Outcome|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
33066|NCT02423993|O4|Outcome|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
33114|NCT02423447|O2|Outcome|G5 Arm|"G5 arm~G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines"
33115|NCT02423447|O1|Outcome|Electro-Flo Arm|"Electro-Flo arm~Electro-Flo Intervention: An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines"
33116|NCT02423447|O2|Outcome|G5 Arm|"G5 arm~G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines"
33067|NCT02423993|O3|Outcome|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
33068|NCT02423993|O2|Outcome|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
33069|NCT02423993|O1|Outcome|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
33070|NCT02423993|O4|Outcome|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
33071|NCT02423993|O3|Outcome|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
33072|NCT02423993|O2|Outcome|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
33073|NCT02423993|O1|Outcome|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
33117|NCT02423447|O1|Outcome|Electro-Flo Arm|Electro-Flo arm Electro-Flo device following the 2012 CFF therapy guidelines
33118|NCT02423447|O2|Outcome|G5 Arm|"G5 arm~G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines"
33119|NCT02423447|O1|Outcome|Electro-Flo Arm|"Electro-Flo arm~Electro-Flo Intervention: An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines"
37222|NCT02379585|B3|Baseline|Total|Total of all reporting groups
33074|NCT02423993|O4|Outcome|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
33075|NCT02423993|O3|Outcome|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
33076|NCT02423993|O2|Outcome|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
33077|NCT02423993|O1|Outcome|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
33078|NCT02423993|O4|Outcome|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
33079|NCT02423993|O3|Outcome|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
33080|NCT02423993|O2|Outcome|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
33120|NCT02423447|O2|Outcome|G5 Arm|"G5 arm~G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines"
33121|NCT02423447|O1|Outcome|Electro-Flo Arm|"Electro-Flo arm~Electro-Flo Intervention: An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines"
33122|NCT02423447|O2|Outcome|G5 Flimm Fighter Arm|G5 Flimm Fighter arm
33123|NCT02423447|O1|Outcome|ElectroFlo Arm|ElectroFlo Arm
33124|NCT02423447|E2|Reported Event|G5 Flimm Fighter|G5 Flimm Fighter
33081|NCT02423993|O1|Outcome|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
33082|NCT02423993|E4|Reported Event|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
33083|NCT02423993|E3|Reported Event|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
33084|NCT02423993|E2|Reported Event|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
33085|NCT02423993|E1|Reported Event|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
33086|NCT02423980|B1|Baseline|G-Pen™ (Glucagon Injection) 1 mg First, Followed by 0.5 mg|A 1 mg dose of G-Pen was given at an initial clinic visit. After a 1-2 week wash-out, subjects received a 0.5 mg dose of G-Pen™ at a second visit.
33087|NCT02423980|P1|Participant Flow|G-Pen™ (Glucagon Injection) 1 mg First, Followed by 0.5 mg|A 1 mg dose of glucagon at an initial clinic visit, followed by a 0.5 mg dose of glucagon given at a subsequent clinic visit after a 1-2 week wash-out.
33088|NCT02423980|O2|Outcome|Glucagon 0.5 mg|"0.5 mg G-Pen™ (glucagon injection)~Glucagon"
33089|NCT02423980|O1|Outcome|Glucagon 1 mg|"1 mg G-Pen™ (glucagon injection)~Glucagon"
33090|NCT02423980|O2|Outcome|Glucagon 0.5 mg|"0.5 mg G-Pen™ (glucagon injection)~Glucagon"
33091|NCT02423980|O1|Outcome|Glucagon 1 mg|"1 mg G-Pen™ (glucagon injection)~Glucagon"
33092|NCT02423980|O2|Outcome|Glucagon 0.5 mg|"0.5 mg G-Pen™ (glucagon injection)~Glucagon"
33093|NCT02423980|O1|Outcome|Glucagon 1 mg|"1 mg G-Pen™ (glucagon injection)~Glucagon"
33094|NCT02423980|E2|Reported Event|Glucagon 0.5 mg|"0.5 mg G-Pen™ (glucagon injection)~Glucagon"
33095|NCT02423980|E1|Reported Event|Glucagon 1 mg|"1 mg G-Pen™ (glucagon injection)~Glucagon"
33096|NCT02423798|B1|Baseline|All Subjects|All Subjects
33097|NCT02423798|P1|Participant Flow|All Subjects|All subjects will receive identical devices and undergo the same experimental procedures.
33098|NCT02423798|O1|Outcome|All Subjects|
33099|NCT02423798|O1|Outcome|All Subjects|All Subjects
33100|NCT02423798|O1|Outcome|All Subjects|All Subjects
33101|NCT02423798|E1|Reported Event|All Subjects|
33102|NCT02423577|B3|Baseline|Total|Total of all reporting groups
33103|NCT02423577|B2|Baseline|Placebo|Placebo: Placebo dry powder administered by nasal inhalation
33104|NCT02423577|B1|Baseline|FF-3 Dry Powder|"FF-3~FF-3 dry powder: FF-3 dry powder administered by nasal inhalation"
33105|NCT02423577|P2|Participant Flow|Placebo|Placebo: Placebo dry powder administered by nasal inhalation
33106|NCT02423577|P1|Participant Flow|FF-3 Dry Powder|"FF-3~FF-3 dry powder: FF-3 dry powder administered by nasal inhalation"
33107|NCT02423577|O2|Outcome|Placebo|Placebo: Placebo dry powder administered by nasal inhalation
33128|NCT02423408|B1|Baseline|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~TNX-201: TNX-201 capsule"
33129|NCT02423408|P2|Participant Flow|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~Placebo: Placebo capsule"
33130|NCT02423408|P1|Participant Flow|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~TNX-201: TNX-201 capsule"
33131|NCT02423408|O2|Outcome|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~Placebo: Placebo capsule"
33132|NCT02423408|O1|Outcome|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~TNX-201: TNX-201 capsule"
33133|NCT02423408|O2|Outcome|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~Placebo: Placebo capsule"
33134|NCT02423408|O1|Outcome|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~TNX-201: TNX-201 capsule"
33135|NCT02423408|O2|Outcome|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~Placebo: Placebo capsule"
33136|NCT02423408|O1|Outcome|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~TNX-201: TNX-201 capsule"
33137|NCT02423408|O2|Outcome|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~Placebo: Placebo capsule"
33138|NCT02423408|O1|Outcome|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~TNX-201: TNX-201 capsule"
33139|NCT02423408|E2|Reported Event|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~Placebo: Placebo capsule"
33140|NCT02423408|E1|Reported Event|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~TNX-201: TNX-201 capsule"
33141|NCT02423317|B3|Baseline|Total|Total of all reporting groups
33142|NCT02423317|B2|Baseline|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
33143|NCT02423317|B1|Baseline|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
33144|NCT02423317|P2|Participant Flow|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
33145|NCT02423317|P1|Participant Flow|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
33146|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
33147|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
33148|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
33149|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
33150|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
33151|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
33152|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
35785|NCT02394756|E3|Reported Event|Comfilcon A|Subjects wore the comfilcon A lens in any of the three periods during the study.
33153|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
33154|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
33155|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
33156|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
33157|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
33158|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
33159|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
33160|NCT02423317|E2|Reported Event|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
33161|NCT02423317|E1|Reported Event|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
33162|NCT02423291|B1|Baseline|Vial for IV Infusion|"This is a single-arm, open-label, multicenter, Phase 2 clinical trial to evaluate the efficacy and safety of Brentuximab vedotin as a single agent in patients with relapsed or refractory PMLBCL who have previously received a first line of treatment with chemotherapy or immunotherapy.20 patients will be treated in this study and All patients will receive 1.8 mg/kg Brentuximab vedotin administered as a single outpatient IV infusion on Day 1 of each 21-day treatment cycle. Patients may continue on study treatment until disease progression or unacceptable toxicity. Patients who achieve stable disease or better as assessed by investigator should receive a minimum of 8, but no more than 16 cycles of study treatment.~Brentuximab Vedotin: Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle."
33163|NCT02423291|P1|Participant Flow|Vial for IV Infusion|"This is a single-arm, open-label, multicenter, Phase 2 clinical trial to evaluate the efficacy and safety of Brentuximab vedotin as a single agent in patients with relapsed or refractory PMLBCL who have previously received a first line of treatment with chemotherapy or immunotherapy.20 patients will be treated in this study and All patients will receive 1.8 mg/kg Brentuximab vedotin administered as a single outpatient IV infusion on Day 1 of each 21-day treatment cycle. Patients may continue on study treatment until disease progression or unacceptable toxicity. Patients who achieve stable disease or better as assessed by investigator should receive a minimum of 8, but no more than 16 cycles of study treatment.~Brentuximab Vedotin: Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle."
33164|NCT02423291|O1|Outcome|Vial for IV Infusion|"This is a single-arm, open-label, multicenter, Phase 2 clinical trial to evaluate the efficacy and safety of Brentuximab vedotin as a single agent in patients with relapsed or refractory PMLBCL who have previously received a first line of treatment with chemotherapy or immunotherapy.20 patients will be treated in this study and All patients will receive 1.8 mg/kg Brentuximab vedotin administered as a single outpatient IV infusion on Day 1 of each 21-day treatment cycle. Patients may continue on study treatment until disease progression or unacceptable toxicity. Patients who achieve stable disease or better as assessed by investigator should receive a minimum of 8, but no more than 16 cycles of study treatment.~Brentuximab Vedotin: Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle."
33165|NCT02423291|E1|Reported Event|Vial for IV Infusion|"This is a single-arm, open-label, multicenter, Phase 2 clinical trial to evaluate the efficacy and safety of Brentuximab vedotin as a single agent in patients with relapsed or refractory PMLBCL who have previously received a first line of treatment with chemotherapy or immunotherapy.20 patients will be treated in this study and All patients will receive 1.8 mg/kg Brentuximab vedotin administered as a single outpatient IV infusion on Day 1 of each 21-day treatment cycle. Patients may continue on study treatment until disease progression or unacceptable toxicity. Patients who achieve stable disease or better as assessed by investigator should receive a minimum of 8, but no more than 16 cycles of study treatment.~Brentuximab Vedotin: Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle."
33166|NCT02423200|B3|Baseline|Total|Total of all reporting groups
33167|NCT02423200|B2|Baseline|VX-745 Dose Level 2|"Active Group 1: VX-745 dose level 2 twice daily~VX-745: Orally-active P38 MAP kinase alpha-selective inhibitor"
33168|NCT02423200|B1|Baseline|VX-745 Dose Level 1|"Active Group 1: VX-745 dose level 1 twice daily~VX-745: Orally-active P38 MAP kinase alpha-selective inhibitor"
33169|NCT02423200|P2|Participant Flow|Neflamapimod (VX-745) Dose Level 2|"Active Group 1: VX-745 125 mg twice daily~Neflamapimod (VX-745): Orally-active P38 MAP kinase alpha-selective inhibitor"
33170|NCT02423200|P1|Participant Flow|Neflamapimod (VX-745) Dose Level 1|"Active Group 1: VX-745 40 mg twice daily~Neflamapimod (VX-745): Orally-active P38 MAP kinase alpha-selective inhibitor"
33171|NCT02423200|O1|Outcome|Overall Study Population|Combined 40 mg and 125 mg subjects
33172|NCT02423200|O1|Outcome|Overall Study Population|Combined 40 mg and 125 mg subjects
33173|NCT02423200|O2|Outcome|Neflamapimod (VX-745) Dose Level 2|"Active Group 1: VX-745 125 mg twice daily~Neflamapimod (VX-745): Orally-active P38 MAP kinase alpha-selective inhibitor"
33174|NCT02423200|O1|Outcome|Neflamapimod (VX-745) Dose Level 1|"Active Group 1: VX-745 40 mg twice daily~Neflamapimod (VX-745): Orally-active P38 MAP kinase alpha-selective inhibitor"
33175|NCT02423200|O1|Outcome|Overall Study Population|Combined 40 mg and 125 mg subjects; N=7 with baseline and Day 42 results
33176|NCT02423200|E1|Reported Event|Overall Study Population|Combined 40 mg and 125 mg subjects. As there was only one subject in the 125 mg dose group (see Pre-Assignment Details), and the blood concentration levels in this subject was similar to that in 125 mg dose group, this subjects data was combined with the 40 mg dose group in the adverse event analysis.
33177|NCT02423109|B1|Baseline|Overall Study|All subjects were wore both fanfilcon A and enfilcon A toric lenses as either the first or second intervention.
33178|NCT02423109|P2|Participant Flow|Randomized for Enfilcon A Lens First, Then Fanfilcon A Lens|"Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.~fanfilcon A: toric contact lens enfilcon A: toric contact lens"
33179|NCT02423109|P1|Participant Flow|Randomized for Fanfilcon A Lens First, Then Enfilcon A Lens|"Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.~fanfilcon A: toric contact lens enfilcon A: toric contact lens"
33180|NCT02423109|O2|Outcome|Overall Study - Follow Up|"Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.~fanfilcon A: contact lens~enfilcon A: contact lens"
33181|NCT02423109|O1|Outcome|Overall Study - Dispense|"Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.~fanfilcon A: contact lens~enfilcon A: contact lens"
33182|NCT02423109|O2|Outcome|Enfilcon A|"All participants who wore enfilcon A lens pair randomly assigned as first or second pair.~enfilcon A: contact lens"
33183|NCT02423109|O1|Outcome|Fanfilcon A|"All participants who wore fanfilcon A lens pair randomly assigned as first or second pair.~fanfilcon A: contact lens"
33184|NCT02423109|E2|Reported Event|Enfilcon A|Participants randomized to wear enfilcon A either as the first or second lens during the cross over study.
33185|NCT02423109|E1|Reported Event|Fanfilcon A|Participants randomized to wear fanfilcon A either as the first or second lens during the cross over study.
33186|NCT02422797|B3|Baseline|Total|Total of all reporting groups
33187|NCT02422797|B2|Baseline|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33188|NCT02422797|B1|Baseline|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33189|NCT02422797|P2|Participant Flow|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33190|NCT02422797|P1|Participant Flow|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33191|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33192|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33193|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33194|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33195|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33196|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
34324|NCT02409459|O1|Outcome|Injectafer|"15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute~Injectafer"
33197|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33198|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33199|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33200|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33201|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33202|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33203|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33204|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33205|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33206|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33207|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33208|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33209|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33210|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33211|NCT02422797|O2|Outcome|RPV 25 mg|Participants received DTG 50 mg +RPV 25 mg together once daily, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33212|NCT02422797|O1|Outcome|DTG 50 mg|Participants received DTG 50 mg + RPV 25 mg together once daily, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33213|NCT02422797|O2|Outcome|RPV 25 mg|Participants received DTG 50 mg +RPV 25 mg together once daily, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33214|NCT02422797|O1|Outcome|DTG 50 mg|Participants received DTG 50 mg + RPV 25 mg together once daily, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33215|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33216|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33217|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33218|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33549|NCT02418468|O2|Outcome|Placebo|Matching placebo indacaterol capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
33219|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33220|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33221|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33222|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33223|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33224|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33225|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33226|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33227|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33228|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33229|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33230|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33231|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33232|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33233|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33234|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33235|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33236|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33237|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33238|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33261|NCT02422303|B1|Baseline|Ketamine Group|"This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia.~ketamine: Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia."
33239|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33240|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33241|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33242|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33243|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33244|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33245|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33246|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33247|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33248|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33249|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33250|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33251|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33252|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33253|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33254|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33255|NCT02422797|O2|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33256|NCT02422797|O1|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33257|NCT02422797|E2|Reported Event|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
33258|NCT02422797|E1|Reported Event|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
33259|NCT02422303|B3|Baseline|Total|Total of all reporting groups
33260|NCT02422303|B2|Baseline|No Ketamine Group|This group will not receive ketamine at induction of general anesthesia.
33263|NCT02422303|P1|Participant Flow|Ketamine Group|"This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia.~ketamine: Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia."
33264|NCT02422303|O2|Outcome|No Ketamine Group|This group will not receive ketamine at induction of general anesthesia.
33265|NCT02422303|O1|Outcome|Ketamine Group|"This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia.~ketamine: Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia."
33266|NCT02422303|E2|Reported Event|No Ketamine Group|This group will not receive ketamine at induction of general anesthesia.
33267|NCT02422303|E1|Reported Event|Ketamine Group|"This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia.~ketamine: Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia."
33268|NCT02421419|B4|Baseline|Total|Total of all reporting groups
33269|NCT02421419|B3|Baseline|Corticosteroid/Saline (CSS) Group|"1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug~Sodium Chloride: Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment"
33270|NCT02421419|B2|Baseline|Corticosteroid/Lidocaine (CSL) Group|"1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug~Xylocaine: a local anesthetic agent"
33271|NCT02421419|B1|Baseline|Corticosteroid Alone (CS) Group|"1 cc dexamethasone sodium phosphate (4mg/ml) injectable~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug"
33272|NCT02421419|P3|Participant Flow|Corticosteroid/Saline (CSS) Group|"1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug~Sodium Chloride: Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment"
33273|NCT02421419|P2|Participant Flow|Corticosteroid/Lidocaine (CSL) Group|"1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug~Xylocaine: a local anesthetic agent"
33274|NCT02421419|P1|Participant Flow|Corticosteroid Alone (CS) Group|"1 cc dexamethasone sodium phosphate (4mg/ml) injectable~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug"
33275|NCT02421419|O3|Outcome|Corticosteroid/Saline (CSS) Group|"1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug~Sodium Chloride: Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment"
33276|NCT02421419|O2|Outcome|Corticosteroid/Lidocaine (CSL) Group|"1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug~Xylocaine: a local anesthetic agent"
33277|NCT02421419|O1|Outcome|Corticosteroid Alone (CS) Group|"1 cc dexamethasone sodium phosphate (4mg/ml) injectable~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug"
33278|NCT02421419|O3|Outcome|Corticosteroid/Saline (CSS) Group|"1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug~Sodium Chloride: Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment"
33279|NCT02421419|O2|Outcome|Corticosteroid/Lidocaine (CSL) Group|"1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug~Xylocaine: a local anesthetic agent"
33280|NCT02421419|O1|Outcome|Corticosteroid Alone (CS) Group|"1 cc dexamethasone sodium phosphate (4mg/ml) injectable~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug"
33281|NCT02421419|O3|Outcome|Corticosteroid/Saline (CSS) Group|"1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug~Sodium Chloride: Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment"
33282|NCT02421419|O2|Outcome|Corticosteroid/Lidocaine (CSL) Group|"1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug~Xylocaine: a local anesthetic agent"
33283|NCT02421419|O1|Outcome|Corticosteroid Alone (CS) Group|"1 cc dexamethasone sodium phosphate (4mg/ml) injectable~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug"
33284|NCT02421419|O3|Outcome|Corticosteroid/Saline (CSS) Group|"1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug~Sodium Chloride: Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment"
33285|NCT02421419|O2|Outcome|Corticosteroid/Lidocaine (CSL) Group|"1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug~Xylocaine: a local anesthetic agent"
33286|NCT02421419|O1|Outcome|Corticosteroid Alone (CS) Group|"1 cc dexamethasone sodium phosphate (4mg/ml) injectable~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug"
33287|NCT02421419|E3|Reported Event|Corticosteroid/Saline (CSS) Group|"1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug~Sodium Chloride: Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment"
33288|NCT02421419|E2|Reported Event|Corticosteroid/Lidocaine (CSL) Group|"1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug~Xylocaine: a local anesthetic agent"
33289|NCT02421419|E1|Reported Event|Corticosteroid Alone (CS) Group|"1 cc dexamethasone sodium phosphate (4mg/ml) injectable~Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug"
33290|NCT02421211|B3|Baseline|Total|Total of all reporting groups
33379|NCT02420951|O2|Outcome|No Injection|"Will not receive injection of bupivacaine prior to catheter removal~No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
33291|NCT02421211|B2|Baseline|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received fixed dose combination (FDC) tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
33292|NCT02421211|B1|Baseline|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
33293|NCT02421211|P2|Participant Flow|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received fixed dose combination (FDC) tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
33294|NCT02421211|P1|Participant Flow|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
33295|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
33296|NCT02421211|O1|Outcome|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
33297|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
33298|NCT02421211|O1|Outcome|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
33299|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
33300|NCT02421211|O1|Outcome|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
33301|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
33302|NCT02421211|O1|Outcome|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
33303|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
33304|NCT02421211|O1|Outcome|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
33305|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
33306|NCT02421211|O1|Outcome|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
33307|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
33308|NCT02421211|O1|Outcome|Panel 2: LDV 90mg/SOF 400mg (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
33309|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
33310|NCT02421211|O1|Outcome|Panel 2: LDV 90mg/SOF 400mg (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
33311|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
33312|NCT02421211|O1|Outcome|Panel 2: LDV 90mg/SOF 400mg (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
33313|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
33314|NCT02421211|O1|Outcome|Panel 2: LDV 90mg/SOF 400mg (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
33315|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
33316|NCT02421211|O1|Outcome|Panel 1: SMV 150 mg + SOF 400 mg (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
33317|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
33318|NCT02421211|O1|Outcome|Panel 1: SMV 150 mg + SOF 400 mg (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
33319|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
33320|NCT02421211|O1|Outcome|Panel 1: SMV 150 mg + SOF 400 mg (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
33321|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
33322|NCT02421211|O1|Outcome|Panel 1: SMV 150 mg + SOF 400 mg (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
33323|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
33324|NCT02421211|O1|Outcome|Panel 2: LDV 90mg/SOF 400mg (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
33325|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
33326|NCT02421211|O1|Outcome|Panel 2: LDV 90mg/SOF 400mg (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
33327|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
33328|NCT02421211|O1|Outcome|Panel 2: LDV 90mg/SOF 400mg (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
33329|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
33330|NCT02421211|O1|Outcome|Panel 1: SMV 150 mg + SOF 400 mg (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
33331|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
33332|NCT02421211|O1|Outcome|Panel 1: SMV 150 mg + SOF 400 mg (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
33333|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
33334|NCT02421211|O1|Outcome|Panel 1: SMV 150 mg + SOF 400 mg (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
33335|NCT02421211|E2|Reported Event|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received fixed dose combination (FDC) tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
33336|NCT02421211|E1|Reported Event|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
33337|NCT02421146|B5|Baseline|Total|Total of all reporting groups
33338|NCT02421146|B4|Baseline|tDCS - Patients|"will receive real transcranial direct current stimulation . Real tDCS stimulation will involve ten 20 minute stimulations daily (at 2 mA anode over the left DLPFC while cathode over the right suborbital region) on 5 weekdays of two consecutive weeks~Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
33339|NCT02421146|B3|Baseline|Sham tDCS - Patients|"The sham group session will contain 20 minute sessions of transcranial direct current stimulation as well, but only the first minute will be with 2mA, then unbeknownst to the subject, the unblinded research assistant will turn off the stimulation.~Transcranial direct current stimulation - Sham: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
33340|NCT02421146|B2|Baseline|tDCS - Healthy Controls|"will receive real transcranial direct current stimulation. Real tDCS stimulation will involve ten 20 minute stimulations daily (at 2 mA anode over the left DLPFC while cathode over the right suborbital region) on 5 weekdays of two consecutive weeks~Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
33550|NCT02418468|O1|Outcome|Indacaterol 150 mcg|Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
33341|NCT02421146|B1|Baseline|Sham tDCS - Healthy Controls|"The sham group session will contain 20 minute sessions of transcranial direct current stimulatio , but only the first minute will be with 2mA, then unbeknownst to the subject, the unblinded research assistant will turn off the stimulation.~Transcranial direct current stimulation - Sham: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
33342|NCT02421146|P4|Participant Flow|tDCS - Patients|"will receive real transcranial direct current stimulation . Real tDCS stimulation will involve ten 20 minute stimulations daily (at 2 mA anode over the left DLPFC while cathode over the right suborbital region) on 5 weekdays of two consecutive weeks~Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
33343|NCT02421146|P3|Participant Flow|Sham tDCS - Patients|"The sham group session will contain 20 minute sessions of transcranial direct current stimulation as well, but only the first minute will be with 2mA, then unbeknownst to the subject, the unblinded research assistant will turn off the stimulation.~Transcranial direct current stimulation - Sham: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
33344|NCT02421146|P2|Participant Flow|tDCS - Healthy Controls|"will receive real transcranial direct current stimulation. Real tDCS stimulation will involve ten 20 minute stimulations daily (at 2 mA anode over the left DLPFC while cathode over the right suborbital region) on 5 weekdays of two consecutive weeks~Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
33345|NCT02421146|P1|Participant Flow|Sham tDCS - Healthy Controls|"The sham group session will contain 20 minute sessions of transcranial direct current stimulatio , but only the first minute will be with 2mA, then unbeknownst to the subject, the unblinded research assistant will turn off the stimulation.~Transcranial direct current stimulation - Sham: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
33346|NCT02421146|O4|Outcome|tDCS - Patients|"will receive real transcranial direct current stimulation . Real tDCS stimulation will involve ten 20 minute stimulations daily (at 2 mA anode over the left DLPFC while cathode over the right suborbital region) on 5 weekdays of two consecutive weeks~Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
33347|NCT02421146|O3|Outcome|Sham tDCS - Patients|"The sham group session will contain 20 minute sessions of transcranial direct current stimulation as well, but only the first minute will be with 2mA, then unbeknownst to the subject, the unblinded research assistant will turn off the stimulation.~Transcranial direct current stimulation - Sham: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
33348|NCT02421146|O2|Outcome|tDCS - Healthy Controls|"will receive real transcranial direct current stimulation. Real tDCS stimulation will involve ten 20 minute stimulations daily (at 2 mA anode over the left DLPFC while cathode over the right suborbital region) on 5 weekdays of two consecutive weeks~Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
33349|NCT02421146|O1|Outcome|Sham tDCS - Healthy Controls|"The sham group session will contain 20 minute sessions of transcranial direct current stimulatio , but only the first minute will be with 2mA, then unbeknownst to the subject, the unblinded research assistant will turn off the stimulation.~Transcranial direct current stimulation - Sham: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
33350|NCT02421146|O4|Outcome|tDCS - Patients|"will receive real transcranial direct current stimulation . Real tDCS stimulation will involve ten 20 minute stimulations daily (at 2 mA anode over the left DLPFC while cathode over the right suborbital region) on 5 weekdays of two consecutive weeks~Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
33351|NCT02421146|O3|Outcome|Sham tDCS - Patients|"The sham group session will contain 20 minute sessions of transcranial direct current stimulation as well, but only the first minute will be with 2mA, then unbeknownst to the subject, the unblinded research assistant will turn off the stimulation.~Transcranial direct current stimulation - Sham: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
33352|NCT02421146|O2|Outcome|tDCS - Healthy Controls|"will receive real transcranial direct current stimulation. Real tDCS stimulation will involve ten 20 minute stimulations daily (at 2 mA anode over the left DLPFC while cathode over the right suborbital region) on 5 weekdays of two consecutive weeks~Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
33380|NCT02420951|O1|Outcome|Injection|"Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal~Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
33586|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
33353|NCT02421146|O1|Outcome|Sham tDCS - Healthy Controls|"The sham group session will contain 20 minute sessions of transcranial direct current stimulatio , but only the first minute will be with 2mA, then unbeknownst to the subject, the unblinded research assistant will turn off the stimulation.~Transcranial direct current stimulation - Sham: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
33354|NCT02421146|E4|Reported Event|tDCS - Patients|"will receive real transcranial direct current stimulation . Real tDCS stimulation will involve ten 20 minute stimulations daily (at 2 mA anode over the left DLPFC while cathode over the right suborbital region) on 5 weekdays of two consecutive weeks~Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
33355|NCT02421146|E3|Reported Event|Sham tDCS - Patients|"The sham group session will contain 20 minute sessions of transcranial direct current stimulation as well, but only the first minute will be with 2mA, then unbeknownst to the subject, the unblinded research assistant will turn off the stimulation.~Transcranial direct current stimulation - Sham: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
33356|NCT02421146|E2|Reported Event|tDCS - Healthy Controls|"will receive real transcranial direct current stimulation. Real tDCS stimulation will involve ten 20 minute stimulations daily (at 2 mA anode over the left DLPFC while cathode over the right suborbital region) on 5 weekdays of two consecutive weeks~Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
33357|NCT02421146|E1|Reported Event|Sham tDCS - Healthy Controls|"The sham group session will contain 20 minute sessions of transcranial direct current stimulatio , but only the first minute will be with 2mA, then unbeknownst to the subject, the unblinded research assistant will turn off the stimulation.~Transcranial direct current stimulation - Sham: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp."
33358|NCT02421120|B1|Baseline|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses~Ceftolozane/Tazobactam: 1 hour intravenous infusion"
33359|NCT02421120|P1|Participant Flow|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses~Ceftolozane/Tazobactam: 1 hour intravenous infusion"
33360|NCT02421120|O1|Outcome|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses~Ceftolozane/Tazobactam: 1 hour intravenous infusion"
33361|NCT02421120|O1|Outcome|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses~Ceftolozane/Tazobactam: 1 hour intravenous infusion"
33362|NCT02421120|O1|Outcome|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses~Ceftolozane/Tazobactam: 1 hour intravenous infusion"
33363|NCT02421120|O1|Outcome|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses~Ceftolozane/Tazobactam: 1 hour intravenous infusion"
33364|NCT02421120|O1|Outcome|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses~Ceftolozane/Tazobactam: 1 hour intravenous infusion"
33365|NCT02421120|E1|Reported Event|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses~Ceftolozane/Tazobactam: 1 hour intravenous infusion"
33366|NCT02420951|B3|Baseline|Total|Total of all reporting groups
33367|NCT02420951|B2|Baseline|No Injection|"Will not receive injection of bupivacaine prior to catheter removal~No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
33368|NCT02420951|B1|Baseline|Injection|"Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal~Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
33369|NCT02420951|P2|Participant Flow|No Injection|"Will not receive injection of bupivacaine prior to catheter removal~No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
33370|NCT02420951|P1|Participant Flow|Injection|"Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal~Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
33371|NCT02420951|O2|Outcome|No Injection|"Will not receive injection of bupivacaine prior to catheter removal~No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
33372|NCT02420951|O1|Outcome|Injection|"Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal~Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
33373|NCT02420951|O2|Outcome|No Injection|"Will not receive injection of bupivacaine prior to catheter removal~No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
33374|NCT02420951|O1|Outcome|Injection|"Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal~Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
33375|NCT02420951|O2|Outcome|No Injection|"Will not receive injection of bupivacaine prior to catheter removal~No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
33376|NCT02420951|O1|Outcome|Injection|"Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal~Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
33377|NCT02420951|O2|Outcome|No Injection|"Will not receive injection of bupivacaine prior to catheter removal~No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
33378|NCT02420951|O1|Outcome|Injection|"Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal~Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
39967|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
33381|NCT02420951|O2|Outcome|No Injection|"Will not receive injection of bupivacaine prior to catheter removal~No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
33382|NCT02420951|O1|Outcome|Injection|"Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal~Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
33383|NCT02420951|E2|Reported Event|No Injection|"Will not receive injection of bupivacaine prior to catheter removal~No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
33384|NCT02420951|E1|Reported Event|Injection|"Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal~Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
33385|NCT02420262|B3|Baseline|Total|Total of all reporting groups
33386|NCT02420262|B2|Baseline|IGlar + IAsp|Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72- 90 mg/dL]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 – 6.0 mmol/L).
33387|NCT02420262|B1|Baseline|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72- 90 mg/dL]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern.
33388|NCT02420262|P2|Participant Flow|IGlar + IAsp|Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72- 90 mg/dL]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 – 6.0 mmol/L).
33389|NCT02420262|P1|Participant Flow|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72- 90 mg/dL]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern.
33390|NCT02420262|O2|Outcome|IGlar + IAsp|Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72- 90 mg/dL]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 – 6.0 mmol/L).
33391|NCT02420262|O1|Outcome|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72- 90 mg/dL]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern.
33392|NCT02420262|O2|Outcome|IGlar + IAsp|Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72- 90 mg/dL]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 – 6.0 mmol/L).
33393|NCT02420262|O1|Outcome|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72- 90 mg/dL]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern.
33394|NCT02420262|O2|Outcome|IGlar + IAsp|Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72- 90 mg/dL]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 – 6.0 mmol/L).
33395|NCT02420262|O1|Outcome|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72- 90 mg/dL]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern.
33396|NCT02420262|O2|Outcome|IGlar + IAsp|Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72- 90 mg/dL]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 – 6.0 mmol/L).
33397|NCT02420262|O1|Outcome|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72- 90 mg/dL]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern.
33398|NCT02420262|O2|Outcome|IGlar + IAsp|Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72- 90 mg/dL]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 – 6.0 mmol/L).
33399|NCT02420262|O1|Outcome|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72- 90 mg/dL]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern.
33400|NCT02420262|E2|Reported Event|IGlar + IAsp|Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72- 90 mg/dL]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 – 6.0 mmol/L).
33401|NCT02420262|E1|Reported Event|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72- 90 mg/dL]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern.
33402|NCT02420210|B1|Baseline|Treatment (Bendamustine, Obinutuzumab, Dexamethasone)|"Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2, obinutuzumab IV over 4 hours on days 1 or 2, 8, and 15 (on both days 1 and 2 in course 1 only), dexamethasone PO daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Obinutuzumab: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
33417|NCT02420093|O2|Outcome|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
33548|NCT02418468|P1|Participant Flow|Indacaterol 150 mcg|Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
33403|NCT02420210|P1|Participant Flow|Treatment (Bendamustine, Obinutuzumab, Dexamethasone)|"Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2, obinutuzumab IV over 4 hours on days 1 or 2, 8, and 15 (on both days 1 and 2 in course 1 only), dexamethasone PO daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Obinutuzumab: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
33404|NCT02420210|O1|Outcome|Treatment (Bendamustine, Obinutuzumab, Dexamethasone)|"Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2, obinutuzumab IV over 4 hours on days 1 or 2, 8, and 15 (on both days 1 and 2 in course 1 only), dexamethasone PO daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Obinutuzumab: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
33405|NCT02420210|O1|Outcome|Treatment (Bendamustine, Obinutuzumab, Dexamethasone)|"Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2, obinutuzumab IV over 4 hours on days 1 or 2, 8, and 15 (on both days 1 and 2 in course 1 only), dexamethasone PO daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Obinutuzumab: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
33406|NCT02420210|O1|Outcome|Treatment (Bendamustine, Obinutuzumab, Dexamethasone)|"Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2, obinutuzumab IV over 4 hours on days 1 or 2, 8, and 15 (on both days 1 and 2 in course 1 only), dexamethasone PO daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Obinutuzumab: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
33407|NCT02420210|O1|Outcome|Treatment (Bendamustine, Obinutuzumab, Dexamethasone)|"Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2, obinutuzumab IV over 4 hours on days 1 or 2, 8, and 15 (on both days 1 and 2 in course 1 only), dexamethasone PO daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Obinutuzumab: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
33408|NCT02420210|O1|Outcome|Treatment (Bendamustine, Obinutuzumab, Dexamethasone)|"Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2, obinutuzumab IV over 4 hours on days 1 or 2, 8, and 15 (on both days 1 and 2 in course 1 only), dexamethasone PO daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Obinutuzumab: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
33409|NCT02420210|O1|Outcome|Treatment (Bendamustine, Obinutuzumab, Dexamethasone)|"Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2, obinutuzumab IV over 4 hours on days 1 or 2, 8, and 15 (on both days 1 and 2 in course 1 only), dexamethasone PO daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Obinutuzumab: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
33410|NCT02420210|O1|Outcome|Treatment (Bendamustine, Obinutuzumab, Dexamethasone)|"Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2, obinutuzumab IV over 4 hours on days 1 or 2, 8, and 15 (on both days 1 and 2 in course 1 only), dexamethasone PO daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Obinutuzumab: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
33411|NCT02420210|E1|Reported Event|Treatment (Bendamustine, Obinutuzumab, Dexamethasone)|"Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2, obinutuzumab IV over 4 hours on days 1 or 2, 8, and 15 (on both days 1 and 2 in course 1 only), dexamethasone PO daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Obinutuzumab: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
33412|NCT02420093|B3|Baseline|Total|Total of all reporting groups
33413|NCT02420093|B2|Baseline|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
33414|NCT02420093|B1|Baseline|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
33415|NCT02420093|P2|Participant Flow|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
33416|NCT02420093|P1|Participant Flow|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
33418|NCT02420093|O1|Outcome|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
33419|NCT02420093|O2|Outcome|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
33420|NCT02420093|O1|Outcome|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
33421|NCT02420093|O2|Outcome|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
33422|NCT02420093|O1|Outcome|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
33423|NCT02420093|O2|Outcome|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
33424|NCT02420093|O1|Outcome|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
33425|NCT02420093|O2|Outcome|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
33426|NCT02420093|O1|Outcome|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
33427|NCT02420093|E2|Reported Event|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
33428|NCT02420093|E1|Reported Event|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
33429|NCT02420041|B3|Baseline|Total|Total of all reporting groups
33430|NCT02420041|B2|Baseline|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
33431|NCT02420041|B1|Baseline|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
33449|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
39968|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
33432|NCT02420041|P2|Participant Flow|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
33433|NCT02420041|P1|Participant Flow|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the sacroiliac joint (SIJ)~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
33434|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
33435|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
33436|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
33437|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
33438|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
33439|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
33440|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
33441|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
33442|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
33443|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
33444|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
33445|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
33446|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
33447|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
33448|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
33527|NCT02419001|E1|Reported Event|Low Dose|1 g ceftriaxone and two low doses of SYN-004
33450|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
33451|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
33452|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
33453|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
33454|NCT02420041|E2|Reported Event|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
33455|NCT02420041|E1|Reported Event|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
33456|NCT02419937|B3|Baseline|Total|Total of all reporting groups
33457|NCT02419937|B2|Baseline|Placebo|"Blinded subjects will be randomized to placebo~Placebo: Saline injection"
33458|NCT02419937|B1|Baseline|Tocilizumab|"Blinded subjects will be randomized to tocilizumab 162 mg subcutaneously once.~Tocilizumab: 162 mg subcutaneously once (vs. 0.9% normal saline placebo injection once in placebo arm)"
33459|NCT02419937|P2|Participant Flow|Placebo|"Blinded subjects will be randomized to placebo~Placebo: Saline injection"
33460|NCT02419937|P1|Participant Flow|Tocilizumab|"Blinded subjects will be randomized to tocilizumab 162 mg subcutaneously once.~Tocilizumab: 162 mg subcutaneously once (vs. 0.9% normal saline placebo injection once in placebo arm)"
33461|NCT02419937|O2|Outcome|Placebo|"Blinded subjects will be randomized to placebo~Placebo: Saline injection"
33462|NCT02419937|O1|Outcome|Tocilizumab|"Blinded subjects will be randomized to tocilizumab 162 mg subcutaneously once.~Tocilizumab: 162 mg subcutaneously once (vs. 0.9% normal saline placebo injection once in placebo arm)"
33463|NCT02419937|E2|Reported Event|Placebo|"Blinded subjects will be randomized to placebo~Placebo: Saline injection"
33464|NCT02419937|E1|Reported Event|Tocilizumab|"Blinded subjects will be randomized to tocilizumab 162 mg subcutaneously once.~Tocilizumab: 162 mg subcutaneously once (vs. 0.9% normal saline placebo injection once in placebo arm)"
33465|NCT02419755|B3|Baseline|Total|Total of all reporting groups
33466|NCT02419755|B2|Baseline|Stratum 2: ALL and MLM|Participants in Stratum 2 [Acute Lymphoid Leukemia (ALL) and Mixed Lineage Malignancies (MLM)] receive mitoxantrone, PEG-L-Asparaginase (or Erwinia L-asparaginase), dexamethasone, bortezomib, vorinostat, cytarabine, methotrexate, hydrocortisone, mercaptopurine, and doxorubicin as described in the Detailed Study Description.
33467|NCT02419755|B1|Baseline|Stratum 1: Myeloid Malignancies|Participants receive cytarabine, bortezomib, vorinostat, methotrexate, hydrocortisone, mitoxantrone as described in the Detailed Study Description.
33468|NCT02419755|P2|Participant Flow|Stratum 2: ALL and MLM|Participants in Stratum 2 [Acute Lymphoid Leukemia (ALL) and Mixed Lineage Malignancies (MLM)] receive mitoxantrone, PEG-L-Asparaginase (or Erwinia L-asparaginase), dexamethasone, bortezomib, vorinostat, cytarabine, methotrexate, hydrocortisone, mercaptopurine, and doxorubicin as described in the Detailed Study Description.
33469|NCT02419755|P1|Participant Flow|Stratum 1: Myeloid Malignancies|Participants receive cytarabine, bortezomib, vorinostat, methotrexate, hydrocortisone, mitoxantrone as described in the Detailed Study Description.
33470|NCT02419755|O2|Outcome|Stratum 2: ALL and MLM|Participants in Stratum 2 [Acute Lymphoid Leukemia (ALL) and Mixed Lineage Malignancies (MLM)] receive mitoxantrone, PEG-L-Asparaginase (or Erwinia L-asparaginase), dexamethasone, bortezomib, vorinostat, cytarabine, methotrexate, hydrocortisone, mercaptopurine, and doxorubicin as described in the Detailed Study Description.
33471|NCT02419755|O1|Outcome|Stratum 1: Myeloid Malignancies|Participants receive cytarabine, bortezomib, vorinostat, methotrexate, hydrocortisone, mitoxantrone as described in the Detailed Study Description.
33472|NCT02419755|O2|Outcome|Stratum 2: ALL and MLM|Participants in Stratum 2 [Acute Lymphoid Leukemia (ALL) and Mixed Lineage Malignancies (MLM)] receive mitoxantrone, PEG-L-Asparaginase (or Erwinia L-asparaginase), dexamethasone, bortezomib, vorinostat, cytarabine, methotrexate, hydrocortisone, mercaptopurine, and doxorubicin as described in the Detailed Study Description.
33473|NCT02419755|O1|Outcome|Stratum 1: Myeloid Malignancies|Participants receive cytarabine, bortezomib, vorinostat, methotrexate, hydrocortisone, mitoxantrone as described in the Detailed Study Description.
33474|NCT02419755|O2|Outcome|Stratum 2: ALL and MLM|Participants in Stratum 2 [Acute Lymphoid Leukemia (ALL) and Mixed Lineage Malignancies (MLM)] receive mitoxantrone, PEG-L-Asparaginase (or Erwinia L-asparaginase), dexamethasone, bortezomib, vorinostat, cytarabine, methotrexate, hydrocortisone, mercaptopurine, and doxorubicin as described in the Detailed Study Description.
33475|NCT02419755|O1|Outcome|Stratum 1: Myeloid Malignancies|Participants receive cytarabine, bortezomib, vorinostat, methotrexate, hydrocortisone, mitoxantrone as described in the Detailed Study Description.
33528|NCT02418676|B4|Baseline|Total|Total of all reporting groups
34325|NCT02409459|O2|Outcome|Placebo|"15 cc of Normal Saline IV push at 2 ml/minute~Normal Saline"
33476|NCT02419755|O2|Outcome|Stratum 2: ALL and MLM|Participants in Stratum 2 [Acute Lymphoid Leukemia (ALL) and Mixed Lineage Malignancies (MLM)] receive mitoxantrone, PEG-L-Asparaginase (or Erwinia L-asparaginase), dexamethasone, bortezomib, vorinostat, cytarabine, methotrexate, hydrocortisone, mercaptopurine, and doxorubicin as described in the Detailed Study Description.
33477|NCT02419755|O1|Outcome|Stratum 1: Myeloid Malignancies|Participants receive cytarabine, bortezomib, vorinostat, methotrexate, hydrocortisone, mitoxantrone as described in the Detailed Study Description.
33478|NCT02419755|O2|Outcome|Stratum 2: ALL and MLM|Participants in Stratum 2 [Acute Lymphoid Leukemia (ALL) and Mixed Lineage Malignancies (MLM)] receive mitoxantrone, PEG-L-Asparaginase (or Erwinia L-asparaginase), dexamethasone, bortezomib, vorinostat, cytarabine, methotrexate, hydrocortisone, mercaptopurine, and doxorubicin as described in the Detailed Study Description.
33479|NCT02419755|O1|Outcome|Stratum 1: Myeloid Malignancies|Participants receive cytarabine, bortezomib, vorinostat, methotrexate, hydrocortisone, mitoxantrone as described in the Detailed Study Description.
33480|NCT02419755|O2|Outcome|Stratum 2: ALL and MLM|Participants in Stratum 2 [Acute Lymphoid Leukemia (ALL) and Mixed Lineage Malignancies (MLM)] receive mitoxantrone, PEG-L-Asparaginase (or Erwinia L-asparaginase), dexamethasone, bortezomib, vorinostat, cytarabine, methotrexate, hydrocortisone, mercaptopurine, and doxorubicin as described in the Detailed Study Description.
33481|NCT02419755|O1|Outcome|Stratum 1: Myeloid Malignancies|Participants receive cytarabine, bortezomib, vorinostat, methotrexate, hydrocortisone, mitoxantrone as described in the Detailed Study Description.
33482|NCT02419755|O2|Outcome|Stratum 2: ALL and MLM|Participants in Stratum 2 [Acute Lymphoid Leukemia (ALL) and Mixed Lineage Malignancies (MLM)] receive mitoxantrone, PEG-L-Asparaginase (or Erwinia L-asparaginase), dexamethasone, bortezomib, vorinostat, cytarabine, methotrexate, hydrocortisone, mercaptopurine, and doxorubicin as described in the Detailed Study Description.
33483|NCT02419755|O1|Outcome|Stratum 1: Myeloid Malignancies|Participants receive cytarabine, bortezomib, vorinostat, methotrexate, hydrocortisone, mitoxantrone as described in the Detailed Study Description.
33484|NCT02419755|O2|Outcome|Stratum 2: ALL and MLM|Participants in Stratum 2 [Acute Lymphoid Leukemia (ALL) and Mixed Lineage Malignancies (MLM)] receive mitoxantrone, PEG-L-Asparaginase (or Erwinia L-asparaginase), dexamethasone, bortezomib, vorinostat, cytarabine, methotrexate, hydrocortisone, mercaptopurine, and doxorubicin as described in the Detailed Study Description.
33485|NCT02419755|O1|Outcome|Stratum 1: Myeloid Malignancies|Participants receive cytarabine, bortezomib, vorinostat, methotrexate, hydrocortisone, mitoxantrone as described in the Detailed Study Description.
33486|NCT02419755|O2|Outcome|Stratum 2: ALL and MLM|Participants in Stratum 2 [Acute Lymphoid Leukemia (ALL) and Mixed Lineage Malignancies (MLM)] receive mitoxantrone, PEG-L-Asparaginase (or Erwinia L-asparaginase), dexamethasone, bortezomib, vorinostat, cytarabine, methotrexate, hydrocortisone, mercaptopurine, and doxorubicin as described in the Detailed Study Description.
33487|NCT02419755|O1|Outcome|Stratum 1: Myeloid Malignancies|Participants receive cytarabine, bortezomib, vorinostat, methotrexate, hydrocortisone, mitoxantrone as described in the Detailed Study Description.
33488|NCT02419755|O2|Outcome|Stratum 2: ALL and MLM|Participants in Stratum 2 [Acute Lymphoid Leukemia (ALL) and Mixed Lineage Malignancies (MLM)] receive mitoxantrone, PEG-L-Asparaginase (or Erwinia L-asparaginase), dexamethasone, bortezomib, vorinostat, cytarabine, methotrexate, hydrocortisone, mercaptopurine, and doxorubicin as described in the Detailed Study Description.
33489|NCT02419755|O1|Outcome|Stratum 1: Myeloid Malignancies|Participants receive cytarabine, bortezomib, vorinostat, methotrexate, hydrocortisone, mitoxantrone as described in the Detailed Study Description.
33490|NCT02419755|E2|Reported Event|Stratum 2: ALL and MLM|Participants in Stratum 2 [Acute Lymphoid Leukemia (ALL) and Mixed Lineage Malignancies (MLM)] receive mitoxantrone, PEG-L-Asparaginase (or Erwinia L-asparaginase), dexamethasone, bortezomib, vorinostat, cytarabine, methotrexate, hydrocortisone, mercaptopurine, and doxorubicin as described in the Detailed Study Description.
33491|NCT02419755|E1|Reported Event|Stratum 1: Myeloid Malignancies|Participants receive cytarabine, bortezomib, vorinostat, methotrexate, hydrocortisone, mitoxantrone as described in the Detailed Study Description.
33492|NCT02419521|B1|Baseline|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System~Resolute Onyx Stent - 2.25 mm - 4.0 mm"
33493|NCT02419521|P1|Participant Flow|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System~Resolute Onyx Stent - 2.25 mm - 4.0 mm"
33494|NCT02419521|O1|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System~Resolute Onyx Stent - 2.25 mm - 4.0 mm"
33495|NCT02419521|O1|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System~Resolute Onyx Stent - 2.25 mm - 4.0 mm"
33496|NCT02419521|O1|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System~Resolute Onyx Stent - 2.25 mm - 4.0 mm"
33497|NCT02419521|O1|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System~Resolute Onyx Stent - 2.25 mm - 4.0 mm"
33498|NCT02419521|O1|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System~Resolute Onyx Stent - 2.25 mm - 4.0 mm"
33499|NCT02419521|O1|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System~Resolute Onyx Stent - 2.25 mm - 4.0 mm"
33500|NCT02419521|O1|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System~Resolute Onyx Stent - 2.25 mm - 4.0 mm"
33501|NCT02419521|O1|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System~Resolute Onyx Stent - 2.25 mm - 4.0 mm"
33502|NCT02419521|O1|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System~Resolute Onyx Stent - 2.25 mm - 4.0 mm"
33503|NCT02419521|E1|Reported Event|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System~Resolute Onyx Stent - 2.25 mm - 4.0 mm"
33504|NCT02419313|B1|Baseline|All Study Participants|All participants included in this crossover design.
33505|NCT02419313|P2|Participant Flow|Incobotulinumtoxin A First, Then Placebo|Subjects will all receive injections with incobotulinumtoxinA injections first. At 12 weeks, these subjects will then cross over and receive placebo in the same distribution as their second treatment.
33506|NCT02419313|P1|Participant Flow|Placebo First, Then Incobotulinumtoxin A|Subjects will all receive injections with saline first. At 12 weeks, these subjects will then cross over and receive Xeomin in the same distribution as their second treatment.
35786|NCT02394756|E2|Reported Event|Lotrafilcon B|Subjects wore the lotrafilcon B lens in any of the three periods during the study.
33507|NCT02419313|O2|Outcome|incobotulinumtoxinA, Xeomin|"Subjects will all receive injections with incobotulinumtoxinA injections, 100unit/cc into 6-10 muscles of the forearm. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. These subjects will then cross over and receive placebo ( saline) in the same distribution as their second treatment.~incobotulinumtoxinA: Subjects randomized to the active drug intervention arm will receive incobotulinumtoxinA (Xeomin). A series of rating scales and examinations will take place prior to treatment and for 24 weeks after treatment. At 12 weeks the subjects will cross over to the placebo (saline) arm."
33508|NCT02419313|O1|Outcome|Placebo, Saline|"Subjects randomized to receive the placebo ( saline) will receive an equivalent volume as the active study drug (1cc). The injections will be into -10 hand and forearm muscles. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. The subject will then cross over to an Active Intervention arm to receive incobotulinumtoxinA which will be injected in the same pattern as the saline.~Saline: same volume as injected for incobotulinum toxin A into forearm muscles under EMG guidance."
33509|NCT02419313|O2|Outcome|incobotulinumtoxinA, Xeomin|"Subjects will all receive injections with incobotulinumtoxinA injections, 100unit/cc into 6-10 muscles of the forearm. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. These subjects will then cross over and receive placebo ( saline) in the same distribution as their second treatment.~incobotulinumtoxinA: Subjects randomized to the active drug intervention arm will receive incobotulinumtoxinA (Xeomin). A series of rating scales and examinations will take place prior to treatment and for 24 weeks after treatment. At 12 weeks the subjects will cross over to the placebo (saline) arm."
33510|NCT02419313|O1|Outcome|Placebo, Saline|"Subjects randomized to receive the placebo ( saline) will receive an equivalent volume as the active study drug (1cc). The injections will be into -10 hand and forearm muscles. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. The subject will then cross over to an Active Intervention arm to receive incobotulinumtoxinA which will be injected in the same pattern as the saline.~Saline: same volume as injected for incobotulinum toxin A into forearm muscles under EMG guidance."
33511|NCT02419313|O2|Outcome|incobotulinumtoxinA, Xeomin|"Subjects will all receive injections with incobotulinumtoxinA injections, 100unit/cc into 6-10 muscles of the forearm. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. These subjects will then cross over and receive placebo ( saline) in the same distribution as their second treatment.~incobotulinumtoxinA: Subjects randomized to the active drug intervention arm will receive incobotulinumtoxinA (Xeomin). A series of rating scales and examinations will take place prior to treatment and for 24 weeks after treatment. At 12 weeks the subjects will cross over to the placebo (saline) arm."
33512|NCT02419313|O1|Outcome|Placebo, Saline|"Subjects randomized to receive the placebo ( saline) will receive an equivalent volume as the active study drug (1cc). The injections will be into -10 hand and forearm muscles. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. The subject will then cross over to an Active Intervention arm to receive incobotulinumtoxinA which will be injected in the same pattern as the saline.~Saline: same volume as injected for incobotulinum toxin A into forearm muscles under EMG guidance."
33513|NCT02419313|E2|Reported Event|incobotulinumtoxinA, Xeomin|"Subjects will all receive injections with incobotulinumtoxinA injections, 100unit/cc into 6-10 muscles of the forearm. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. These subjects will then cross over and receive placebo ( saline) in the same distribution as their second treatment.~incobotulinumtoxinA: Subjects randomized to the active drug intervention arm will receive incobotulinumtoxinA (Xeomin). A series of rating scales and examinations will take place prior to treatment and for 24 weeks after treatment. At 12 weeks the subjects will cross over to the placebo (saline) arm."
33514|NCT02419313|E1|Reported Event|Placebo, Saline|"Subjects randomized to receive the placebo ( saline) will receive an equivalent volume as the active study drug (1cc). The injections will be into -10 hand and forearm muscles. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. The subject will then cross over to an Active Intervention arm to receive incobotulinumtoxinA which will be injected in the same pattern as the saline.~Saline: same volume as injected for incobotulinum toxin A into forearm muscles under EMG guidance."
33515|NCT02419001|B3|Baseline|Total|Total of all reporting groups
33516|NCT02419001|B2|Baseline|High Dose|1 g ceftriaxone and two high doses of SYN-004
33517|NCT02419001|B1|Baseline|Low Dose|1 g ceftriaxone and two low doses of SYN-004
33518|NCT02419001|P2|Participant Flow|High Dose|1 g ceftriaxone and two high doses (150 mg) of SYN-004
33519|NCT02419001|P1|Participant Flow|Low Dose|1 g ceftriaxone and two low doses (75 mg) of SYN-004
33520|NCT02419001|O2|Outcome|Treatment Sequence AC|Period 1: Ceftriaxone 1 g infused IV over 30 minutes Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg (2 x 75 mg capsules) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
33521|NCT02419001|O1|Outcome|Treatment Sequence AB|Period 1: Ceftriaxone 1 g infused IV over 30 minutes Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg (1 x 75 mg capsule) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
33522|NCT02419001|O2|Outcome|Treatment Sequence AC|Period 1: Ceftriaxone 1 g infused IV over 30 minutes Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg (2 x 75 mg capsules) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
33523|NCT02419001|O1|Outcome|Treatment Sequence AB|Period 1: Ceftriaxone 1 g infused IV over 30 minutes Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg (1 x 75 mg capsule) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
33524|NCT02419001|O2|Outcome|Treatment Sequence AC|Period 1: Ceftriaxone 1 g infused IV over 30 minutes Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg (2 x 75 mg capsules) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
33525|NCT02419001|O1|Outcome|Treatment Sequence AB|Period 1: Ceftriaxone 1 g infused IV over 30 minutes Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg (1 x 75 mg capsule) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
33526|NCT02419001|E2|Reported Event|High Dose|1 g ceftriaxone and two high doses of SYN-004
33529|NCT02418676|B3|Baseline|Control Gel|"A quantity of 5 grams of gel without active was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Control gel: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
33530|NCT02418676|B2|Baseline|Gel With Insulin|"A quantity of 5 grams of gel with insulin was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with insulin: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
33531|NCT02418676|B1|Baseline|Gel With HPβCD-I Complex|"A quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with HPβCD-I complex: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with HPβCD-I complex was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
33532|NCT02418676|P3|Participant Flow|Control Gel|"A quantity of 5 grams of gel without active was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Control gel: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
33533|NCT02418676|P2|Participant Flow|Gel With Insulin|"A quantity of 5 grams of gel with insulin was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with insulin: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
33534|NCT02418676|P1|Participant Flow|Gel With HPβCD-I Complex|"A quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with HPβCD-I complex: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with HPβCD-I complex was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
33535|NCT02418676|O3|Outcome|Control Gel|"A quantity of 5 grams of gel without active was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Control gel: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
33536|NCT02418676|O2|Outcome|Gel With Insulin|"A quantity of 5 grams of gel with insulin was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with insulin: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
33537|NCT02418676|O1|Outcome|Gel With HPβCD-I Complex|"A quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with HPβCD-I complex: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with HPβCD-I complex was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
33538|NCT02418676|O3|Outcome|Control Gel|"A quantity of 5 grams of gel without active was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Control gel: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
33539|NCT02418676|O2|Outcome|Gel With Insulin|"A quantity of 5 grams of gel with insulin was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with insulin: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
33540|NCT02418676|O1|Outcome|Gel With HPβCD-I Complex|"A quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with HPβCD-I complex: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with HPβCD-I complex was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
33541|NCT02418676|E3|Reported Event|Control Gel|"A quantity of 5 grams of gel without active was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Control gel: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
33542|NCT02418676|E2|Reported Event|Gel With Insulin|"A quantity of 5 grams of gel with insulin was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with insulin: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
33543|NCT02418676|E1|Reported Event|Gel With HPβCD-I Complex|"A quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with HPβCD-I complex: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with HPβCD-I complex was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
33544|NCT02418468|B3|Baseline|Total|Total of all reporting groups
33545|NCT02418468|B2|Baseline|Placebo|Matching placebo indacaterol capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
33546|NCT02418468|B1|Baseline|Indacaterol 150 mcg|Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
33547|NCT02418468|P2|Participant Flow|Placebo|Matching placebo indacaterol capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
34326|NCT02409459|O1|Outcome|Injectafer|"15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute~Injectafer"
33551|NCT02418468|E2|Reported Event|Placebo|Matching placebo indacaterol capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
33552|NCT02418468|E1|Reported Event|Indacaterol 150 mcg|Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
33553|NCT02418234|B1|Baseline|TKI-PD|Patients with advanced or recurrent NSCLC patients had progressed during EGFR-TKIs treatment
33554|NCT02418234|P1|Participant Flow|TKI-PD|Patients with advanced or recurrent NSCLC who had progressed during EGFR-TKIs treatment
33555|NCT02418234|O3|Outcome|Other Sites Failures|Other sites failures were defined as PD lesions in other distant site, or multiple sites including chest or intracranial.
33556|NCT02418234|O2|Outcome|Brain Limited|Brain limited was defined as a PD in original site or a new site of metastatic disease in brain, with no evidence of extracranial progression.
33557|NCT02418234|O1|Outcome|Chest Limited|Chest limited was defined as progressive disease (PD) in lung/pleura tissue and lymph nodes limited in chest, and no evidence of progression beyond the chest was identified.
33558|NCT02418234|O3|Outcome|Other Sites Failures|Other sites failures were defined as PD lesions in other distant site, or multiple sites including chest or intracranial.
33559|NCT02418234|O2|Outcome|Brain Limited|Brain limited was defined as a PD in original site or a new site of metastatic disease in brain, with no evidence of extracranial progression.
33560|NCT02418234|O1|Outcome|Chest Limited|Chest limited was defined as progressive disease (PD) in lung/pleura tissue and lymph nodes limited in chest, and no evidence of progression beyond the chest was identified.
33561|NCT02418234|O1|Outcome|TKI-PD|Patients with advanced or recurrent NSCLC who had progressed during EGFR-TKIs treatment
33562|NCT02418234|O1|Outcome|TKI-PD|
33563|NCT02418234|E1|Reported Event|TKI-PD|Patients with advanced or recurrent NSCLC patients had progressed during EGFR-TKIs treatment.
33564|NCT02418026|B3|Baseline|Total|Total of all reporting groups
33565|NCT02418026|B2|Baseline|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
33566|NCT02418026|B1|Baseline|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
33567|NCT02418026|P2|Participant Flow|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
33568|NCT02418026|P1|Participant Flow|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
33569|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
33570|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
33571|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
33572|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
33573|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
33574|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
33575|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
33576|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
33577|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
33578|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
33579|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
33580|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
33581|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
33582|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
33583|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
33584|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
33585|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
33587|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
33588|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
33589|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
33590|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
33591|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
33592|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
33593|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
33594|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
33595|NCT02418026|E2|Reported Event|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
33596|NCT02418026|E1|Reported Event|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
33597|NCT02417961|B1|Baseline|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
33598|NCT02417961|P1|Participant Flow|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
33599|NCT02417961|O1|Outcome|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
33600|NCT02417961|O1|Outcome|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
33601|NCT02417961|O1|Outcome|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
33602|NCT02417961|O1|Outcome|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
33603|NCT02417961|O1|Outcome|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
33604|NCT02417961|O1|Outcome|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
33605|NCT02417961|O1|Outcome|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
33606|NCT02417961|E1|Reported Event|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
33607|NCT02417753|B1|Baseline|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle~AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
33608|NCT02417753|P1|Participant Flow|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle~AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
33609|NCT02417753|O1|Outcome|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle~AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
33610|NCT02417753|O1|Outcome|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle~AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
33611|NCT02417753|O1|Outcome|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle~AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
33612|NCT02417753|O1|Outcome|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle~AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
33613|NCT02417753|O1|Outcome|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle~AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
33614|NCT02417753|O1|Outcome|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle~AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
33615|NCT02417753|O1|Outcome|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle~AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
33616|NCT02417753|E1|Reported Event|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle~AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
33617|NCT02417532|B1|Baseline|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
33618|NCT02417532|P1|Participant Flow|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
33619|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
33620|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
33621|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
33622|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
34327|NCT02409459|O2|Outcome|Placebo|"15 cc of Normal Saline IV push at 2 ml/minute~Normal Saline"
33623|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
33624|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
33625|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
33626|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
33627|NCT02417532|E1|Reported Event|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
33628|NCT02417376|B3|Baseline|Total|Total of all reporting groups
33629|NCT02417376|B2|Baseline|Control|No periodontal intervention in any form.
33630|NCT02417376|B1|Baseline|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
33631|NCT02417376|P2|Participant Flow|Control|No periodontal intervention in any form.
33632|NCT02417376|P1|Participant Flow|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
33633|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
33634|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
33635|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
33636|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
33637|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
33638|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
33639|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
33640|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
33641|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
33702|NCT02416934|P2|Participant Flow|Treatment 0; Saline Placebo|Swallowing difficulty at various time points as measured by the DSQ and Bazaz for subjects randomized to Treatment 0; Saline placebo
33703|NCT02416934|P1|Participant Flow|Treatment 1; Dexamethasone|Swallowing difficulty at various time points as measured by the DSQ and Bazaz for subjects randomized to Treatment 1; Dexamethasone
33704|NCT02416934|O2|Outcome|Change in Quality of Life Saline Placebo|Change in quality of life from baseline to 1 year (or last visit as appropriate.) Not all subjects came for 1 year follow up.
39969|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
33642|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
33643|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
33644|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
33645|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
33646|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
33647|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
33648|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
33649|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
33650|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
33651|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
33652|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
33653|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
33654|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
33655|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
33656|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
33657|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
33658|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
33659|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
33660|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
33661|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
33662|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
33663|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
33664|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
33665|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
33666|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
33667|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
33668|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
33669|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
33670|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
33671|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
33672|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
33673|NCT02417376|E2|Reported Event|Control|No periodontal intervention in any form.
33674|NCT02417376|E1|Reported Event|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
33675|NCT02417129|B1|Baseline|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
33676|NCT02417129|P2|Participant Flow|Rituximab (US-licensed Rituxan)|Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
33677|NCT02417129|P1|Participant Flow|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
33678|NCT02417129|O2|Outcome|Rituximab (US-licensed Rituxan)|Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
33679|NCT02417129|O1|Outcome|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
33680|NCT02417129|O2|Outcome|Rituximab (US-licensed Rituxan)|Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
33681|NCT02417129|O1|Outcome|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
33682|NCT02417129|O2|Outcome|Rituximab (US-licensed Rituxan)|Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
33683|NCT02417129|O1|Outcome|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
33684|NCT02417129|E2|Reported Event|Rituximab (US-licensed Rituxan)|Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
33685|NCT02417129|E1|Reported Event|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
33686|NCT02416973|B4|Baseline|Total|Total of all reporting groups
33687|NCT02416973|B3|Baseline|Active Treatment With Alternative Settings|"Active Provant Treatment with alternative settings~Provant"
33688|NCT02416973|B2|Baseline|Active Treatment|"Active Provant Treatment~Provant"
33689|NCT02416973|B1|Baseline|Sham of Provant|"Sham of Provant~Provant"
33690|NCT02416973|P3|Participant Flow|Active Treatment With Alternative Settings|"Active Provant Treatment with alternative settings~Provant"
33691|NCT02416973|P2|Participant Flow|Active Treatment|"Active Provant Treatment~Provant"
33692|NCT02416973|P1|Participant Flow|Sham of Provant|"Sham of Provant~Provant"
33693|NCT02416973|O3|Outcome|Active Treatment With Alternative Settings|"Active Provant Treatment with alternative settings~Provant"
33694|NCT02416973|O2|Outcome|Active Treatment|"Active Provant Treatment~Provant"
33695|NCT02416973|O1|Outcome|Sham of Provant|"Sham of Provant~Provant"
33696|NCT02416973|E3|Reported Event|Active Treatment With Alternative Settings|"Active Provant Treatment with alternative settings~Provant"
33697|NCT02416973|E2|Reported Event|Active Treatment|"Active Provant Treatment~Provant"
33698|NCT02416973|E1|Reported Event|Sham of Provant|"Sham of Provant~Provant"
33699|NCT02416934|B3|Baseline|Total|Total of all reporting groups
33700|NCT02416934|B2|Baseline|Treatment 0; Saline Placebo|"Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.~Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Patients in the control(saline) group will receive a similar volume of saline on the same schedule for three doses.~Treatment 0; Saline placebo: Saline (placebo) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose."
33701|NCT02416934|B1|Baseline|Treatment 1; Dexamethasone|"Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.~Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Patients in the control(saline) group will receive a similar volume of saline on the same schedule for three doses.~Treatment 1; Dexamethasone: Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose."
38140|NCT02370602|E2|Reported Event|TAK-063|TAK-063 3 to 1000 mg, tablets, orally, once, on Day 1.
33705|NCT02416934|O1|Outcome|Change in Quality of Life Dexamethasone|Change in quality of life from baseline to 1 year (or last visit as appropriate). Not all subjects came for 1 year follow up.
33706|NCT02416934|O4|Outcome|Saline Placebo Bazaz|"Treatment 0; Saline Placebo. Treatment 0; Saline Placebo. Patients undergoing elective anterior cervical spine surgery wereseen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.~Patients were randomized to either the steroid administration group or the saline administration group. Patients randomized to the control (saline) group received 0.3 mg/kg of intravenous saline within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of saline.~Treatment 0; Control (Saline) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose."
33707|NCT02416934|O3|Outcome|Dexamethasone Bazaz|"Treatment 1; Dexamethasone. Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery were seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.~Patients were randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group received 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone.~Treatment 1; Dexamethasone: Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose."
33708|NCT02416934|O2|Outcome|Saline Placebo DSQ|"Treatment 0; Saline Placebo. Patients undergoing elective anterior cervical spine surgery wereseen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.~Patients were randomized to either the steroid administration group or the saline administration group. Patients randomized to the control (saline) group received 0.3 mg/kg of intravenous saline within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of saline.~Treatment 0; Control (Saline) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose."
33709|NCT02416934|O1|Outcome|Dexamethasone DSQ|"Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery were seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.~Patients were randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group received 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone.~Treatment 1; Dexamethasone: Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose."
33710|NCT02416934|E2|Reported Event|Treatment 0; Saline Placebo|Swallowing difficulty. Two measurement surveys were used: The Dysphagia Short Questionnaire: An Instrument for Evaluation of Dysphagia (DSQ) and Bazaz Dysphagia Scale (Bazaz). The DSQ and Bazaz determine levels of dysphagia over time after anterior cervical spine surgery. A DSQ score is calculated by summing up the points given for each item to a maximum of 18 points, where lower scores represent milder symptoms (zero indicates no symptoms) and vice versa. For the Bazaz score, symptoms are measured as 'none', 'mild', 'moderate', or 'severe'. Zero indicates none or no symptoms, 1 indicates mild, 2 indicates moderate, 3 indicates severe. Numbers of subjects reporting any difficulty swallowing (had to have a score of at least 1) at various time points are reported.
33711|NCT02416934|E1|Reported Event|Treatment 1; Dexamethasone|Swallowing difficulty. Two measurement surveys were used: The Dysphagia Short Questionnaire: An Instrument for Evaluation of Dysphagia (DSQ) and Bazaz Dysphagia Scale (Bazaz). The DSQ and Bazaz determine levels of dysphagia over time after anterior cervical spine surgery. A DSQ score is calculated by summing up the points given for each item to a maximum of 18 points, where lower scores represent milder symptoms (zero indicates no symptoms) and vice versa. For the Bazaz score, symptoms are measured as 'none', 'mild', 'moderate', or 'severe'. Zero indicates none or no symptoms, 1 indicates mild, 2 indicates moderate, 3 indicates severe. Numbers of subjects reporting any difficulty swallowing (had to have a score of at least 1) at various time points are reported.
33712|NCT02416180|B1|Baseline|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
33713|NCT02416180|P1|Participant Flow|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via metered dose inhaler (MDI) for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI Patient Information Leaflet (PIL) and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
33714|NCT02416180|O1|Outcome|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
33715|NCT02416180|O1|Outcome|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
33743|NCT02415959|O2|Outcome|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
39970|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
33716|NCT02416180|O1|Outcome|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
33717|NCT02416180|O1|Outcome|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
33718|NCT02416180|E1|Reported Event|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
33719|NCT02415959|B6|Baseline|Total|Total of all reporting groups
33720|NCT02415959|B5|Baseline|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
33721|NCT02415959|B4|Baseline|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
33722|NCT02415959|B3|Baseline|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
33723|NCT02415959|B2|Baseline|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
33724|NCT02415959|B1|Baseline|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
33725|NCT02415959|P5|Participant Flow|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
33726|NCT02415959|P4|Participant Flow|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
33727|NCT02415959|P3|Participant Flow|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
33728|NCT02415959|P2|Participant Flow|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
33729|NCT02415959|P1|Participant Flow|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
33730|NCT02415959|O5|Outcome|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
33731|NCT02415959|O4|Outcome|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
33732|NCT02415959|O3|Outcome|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
33733|NCT02415959|O2|Outcome|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
33734|NCT02415959|O1|Outcome|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
33735|NCT02415959|O5|Outcome|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
33736|NCT02415959|O4|Outcome|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
33737|NCT02415959|O3|Outcome|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
33738|NCT02415959|O2|Outcome|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
33739|NCT02415959|O1|Outcome|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
33740|NCT02415959|O5|Outcome|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
33741|NCT02415959|O4|Outcome|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
33742|NCT02415959|O3|Outcome|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
39090|NCT02362360|B1|Baseline|Overall Study Population|All subjects included in the investigation
33744|NCT02415959|O1|Outcome|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
33745|NCT02415959|O5|Outcome|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
33746|NCT02415959|O4|Outcome|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
33747|NCT02415959|O3|Outcome|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
33748|NCT02415959|O2|Outcome|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
33749|NCT02415959|O1|Outcome|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
33750|NCT02415959|O5|Outcome|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
33751|NCT02415959|O4|Outcome|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
33752|NCT02415959|O3|Outcome|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
33753|NCT02415959|O2|Outcome|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
33754|NCT02415959|O1|Outcome|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
33755|NCT02415959|E5|Reported Event|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
33756|NCT02415959|E4|Reported Event|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
33757|NCT02415959|E3|Reported Event|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
33758|NCT02415959|E2|Reported Event|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
33759|NCT02415959|E1|Reported Event|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
33760|NCT02415439|B14|Baseline|Total|Total of all reporting groups
33761|NCT02415439|B13|Baseline|Placebo MAD|Subjects were orally administered placebo daily for 14 days under fasted conditions
33762|NCT02415439|B12|Baseline|VBP15- 20.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions
33763|NCT02415439|B11|Baseline|VBP15- 9.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions
33764|NCT02415439|B10|Baseline|VBP15 - 3.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions
33765|NCT02415439|B9|Baseline|VBP15- 1.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions
33766|NCT02415439|B8|Baseline|Placebo SAD|Subjects were orally administered a single dose of placebo under fasted conditions
33767|NCT02415439|B7|Baseline|VBP15- 20.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions
33768|NCT02415439|B6|Baseline|VBP15- 8.0 mg/kg Fed SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high fat/high calorie meal
33769|NCT02415439|B5|Baseline|VBP15- 8.0 mg/kg Fasted SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions
33770|NCT02415439|B4|Baseline|VBP15- 3.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions
33771|NCT02415439|B3|Baseline|VBP15- 1.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions
33772|NCT02415439|B2|Baseline|VBP15- 0.3 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions
33773|NCT02415439|B1|Baseline|VBP15- 0.1 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions
33774|NCT02415439|P13|Participant Flow|Placebo MAD|Subjects were orally administered placebo daily for 14 days under fasted conditions.
33775|NCT02415439|P12|Participant Flow|VBP15- 20 mg/kg 14 Day MAD|Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
33776|NCT02415439|P11|Participant Flow|VBP15- 9.0 mg/kg 14 Day MAD|Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
33777|NCT02415439|P10|Participant Flow|VBP15- 3.0 mg/kg 14 Day MAD|Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
33778|NCT02415439|P9|Participant Flow|VBP15- 1.0 mg/kg 14 Day MAD|Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
33779|NCT02415439|P8|Participant Flow|Placebo SAD|Subjects were orally administered a single dose of placebo under fasted conditions.
33780|NCT02415439|P7|Participant Flow|VBP15- 20.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions.
33781|NCT02415439|P6|Participant Flow|VBP15- 8.0 mg/kg Fed SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high fat/high calorie meal.
33782|NCT02415439|P5|Participant Flow|VBP15- 8.0 mg/kg Fasted SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
33783|NCT02415439|P4|Participant Flow|VBP15- 3.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
33784|NCT02415439|P3|Participant Flow|VBP15- 1.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
33785|NCT02415439|P2|Participant Flow|VBP15- 0.3 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
33786|NCT02415439|P1|Participant Flow|VBP15- 0.1 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.
33787|NCT02415439|O5|Outcome|Placebo MAD|Subjects were orally admistered placebo daily for 14 days under fasted conditions.
33788|NCT02415439|O4|Outcome|VBP15- 20.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
33789|NCT02415439|O3|Outcome|VBP15- 9.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
33790|NCT02415439|O2|Outcome|VBP15- 3.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
33791|NCT02415439|O1|Outcome|VBP15- 1.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
33792|NCT02415439|O5|Outcome|Placebo MAD|Subjects were orally admistered placebo daily for 14 days under fasted conditions.
33793|NCT02415439|O4|Outcome|VBP15- 20.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
33794|NCT02415439|O3|Outcome|VBP15- 9.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
33795|NCT02415439|O2|Outcome|VBP15- 3.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
33796|NCT02415439|O1|Outcome|VBP15- 1.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
33797|NCT02415439|O5|Outcome|Placebo MAD|Subjects were orally admistered placebo daily for 14 days under fasted conditions.
33798|NCT02415439|O4|Outcome|VBP15- 20.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
33799|NCT02415439|O3|Outcome|VBP15- 9.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
33800|NCT02415439|O2|Outcome|VBP15- 3.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
33801|NCT02415439|O1|Outcome|VBP15- 1.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
33802|NCT02415439|O8|Outcome|Placebo SAD|Subjects were administered a single dose of placebo under fasted conditions.
33803|NCT02415439|O7|Outcome|VBP15- 20.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
33804|NCT02415439|O6|Outcome|VBP15- 8.0 mg/kg Fed SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
33805|NCT02415439|O5|Outcome|VBP15- 8.0 mg/kg Fasting SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
33806|NCT02415439|O4|Outcome|VBP15- 3.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
33807|NCT02415439|O3|Outcome|VBP15- 1.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
33808|NCT02415439|O2|Outcome|VBP15- 0.3 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
33809|NCT02415439|O1|Outcome|VBP15- 0.1 mg/kg SAD|Subjects were administered single dose of VBP15 at 0.1 mg/kg under fasted conditions.
33810|NCT02415439|O8|Outcome|Placebo SAD|Subjects were administered a single dose of placebo under fasted conditions.
33811|NCT02415439|O7|Outcome|VBP15- 20.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
33812|NCT02415439|O6|Outcome|VBP15- 8.0 mg/kg Fed SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
33813|NCT02415439|O5|Outcome|VBP15- 8.0 mg/kg Fasted SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
33814|NCT02415439|O4|Outcome|VBP15- 3.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
33815|NCT02415439|O3|Outcome|VBP15- 1.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
33816|NCT02415439|O2|Outcome|VBP15- 0.3 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
33817|NCT02415439|O1|Outcome|VBP15- 0.1 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.
33818|NCT02415439|O8|Outcome|Placebo SAD|Subjects were administered a single dose of placebo under fasted conditions.
33819|NCT02415439|O7|Outcome|VBP15- 20.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
33820|NCT02415439|O6|Outcome|VBP15- 8.0 mg/kg Fed SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
33821|NCT02415439|O5|Outcome|VBP15- 8.0 mg/kg Fasting SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
33822|NCT02415439|O4|Outcome|VBP15- 3.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
33823|NCT02415439|O3|Outcome|VBP15- 1.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
33824|NCT02415439|O2|Outcome|VBP15- 0.3 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
33825|NCT02415439|O1|Outcome|VBP15- 0.1 mg/kg SAD|Subjects were administered single dose of VBP15 at 0.1 mg/kg under fasted conditions.
33826|NCT02415439|E13|Reported Event|Placebo MAD|Subjects were orally administered a dose of placebo daily for 14 days under fasted conditions.
39971|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
33827|NCT02415439|E12|Reported Event|VBP15- 20.0 mg/kg 14 Days MAD|Subjects were orally administered a dose of VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
33828|NCT02415439|E11|Reported Event|VBP15- 9.0 mg/kg 14 Days MAD|Subjects were orally administered a dose of VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
33829|NCT02415439|E10|Reported Event|VBP15- 3.0 mg/kg 14 Days MAD|Subjects were orally administered a dose of VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
33830|NCT02415439|E9|Reported Event|VBP15- 1.0 mg/kg 14 Days MAD|Subjects were orally administered a dose of VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
33831|NCT02415439|E8|Reported Event|Placebo SAD|Subjects were orally administered a single dose of placebo under fasted conditions.
33832|NCT02415439|E7|Reported Event|VBP15- 20.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
33833|NCT02415439|E6|Reported Event|VBP15- 8.0 mg/kg Fed SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
33834|NCT02415439|E5|Reported Event|VBP15- 8.0 mg/kg Fasted SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
33835|NCT02415439|E4|Reported Event|VBP15- 3.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
33836|NCT02415439|E3|Reported Event|VBP15- 1.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
33837|NCT02415439|E2|Reported Event|VBP15- 0.3 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
33838|NCT02415439|E1|Reported Event|VBP15- 0.1 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.
33839|NCT02415166|B5|Baseline|Total|Total of all reporting groups
33840|NCT02415166|B4|Baseline|PLACEBO HC|"SALINE (0.5ML) DELIVERED I.M.~NaCl-saline placebo: placebo"
33841|NCT02415166|B3|Baseline|VACCINE HC|"SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.~INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER"
33842|NCT02415166|B2|Baseline|PLACEBO MDD|"SALINE (0.5ML) DELIVERED I.M.~NaCl-saline placebo: placebo"
33843|NCT02415166|B1|Baseline|VACCINE MDD|"SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.~INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER"
33844|NCT02415166|P4|Participant Flow|PLACEBO HC|"SALINE (0.5ML) DELIVERED I.M.~NaCl-saline placebo: placebo"
33845|NCT02415166|P3|Participant Flow|VACCINE HC|"SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.~INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER"
33846|NCT02415166|P2|Participant Flow|PLACEBO MDD|"SALINE (0.5ML) DELIVERED I.M.~NaCl-saline placebo: placebo"
33847|NCT02415166|P1|Participant Flow|VACCINE MDD|"SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.~INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER"
33848|NCT02415166|O4|Outcome|PLACEBO HC|"SALINE (0.5ML) DELIVERED I.M.~NaCl-saline placebo: placebo"
33849|NCT02415166|O3|Outcome|VACCINE HC|"SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.~INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER"
33850|NCT02415166|O2|Outcome|PLACEBO MDD|"SALINE (0.5ML) DELIVERED I.M.~NaCl-saline placebo: placebo"
33851|NCT02415166|O1|Outcome|VACCINE MDD|"SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.~INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER"
33852|NCT02415166|O4|Outcome|PLACEBO HC|"SALINE (0.5ML) DELIVERED I.M.~NaCl-saline placebo: placebo"
33853|NCT02415166|O3|Outcome|VACCINE HC|"SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.~INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER"
33854|NCT02415166|O2|Outcome|PLACEBO MDD|"SALINE (0.5ML) DELIVERED I.M.~NaCl-saline placebo: placebo"
33855|NCT02415166|O1|Outcome|VACCINE MDD|"SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.~INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER"
33856|NCT02415166|O4|Outcome|PLACEBO HC|"SALINE (0.5ML) DELIVERED I.M.~NaCl-saline placebo: placebo"
33857|NCT02415166|O3|Outcome|VACCINE HC|"SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.~INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER"
33858|NCT02415166|O2|Outcome|PLACEBO MDD|"SALINE (0.5ML) DELIVERED I.M.~NaCl-saline placebo: placebo"
33859|NCT02415166|O1|Outcome|VACCINE MDD|"SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.~INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER"
33860|NCT02415166|O4|Outcome|PLACEBO HC|"SALINE (0.5ML) DELIVERED I.M.~NaCl-saline placebo: placebo"
33861|NCT02415166|O3|Outcome|VACCINE HC|"SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.~INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER"
33862|NCT02415166|O2|Outcome|PLACEBO MDD|"SALINE (0.5ML) DELIVERED I.M.~NaCl-saline placebo: placebo"
33863|NCT02415166|O1|Outcome|VACCINE MDD|"SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.~INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER"
33864|NCT02415166|O4|Outcome|PLACEBO HC|"SALINE (0.5ML) DELIVERED I.M.~NaCl-saline placebo: placebo"
33865|NCT02415166|O3|Outcome|VACCINE HC|"SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.~INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER"
33866|NCT02415166|O2|Outcome|PLACEBO MDD|"SALINE (0.5ML) DELIVERED I.M.~NaCl-saline placebo: placebo"
33867|NCT02415166|O1|Outcome|VACCINE MDD|"SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.~INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER"
33868|NCT02415166|E4|Reported Event|PLACEBO HC|"SALINE (0.5ML) DELIVERED I.M.~NaCl-saline placebo: placebo"
33869|NCT02415166|E3|Reported Event|VACCINE HC|"SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.~INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER"
33870|NCT02415166|E2|Reported Event|PLACEBO MDD|"SALINE (0.5ML) DELIVERED I.M.~NaCl-saline placebo: placebo"
33871|NCT02415166|E1|Reported Event|VACCINE MDD|"SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.~INFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER"
33872|NCT02415127|B3|Baseline|Total|Total of all reporting groups
33873|NCT02415127|B2|Baseline|Placebo|SC doses of placebo TIW for a total of 26 weeks.
33874|NCT02415127|B1|Baseline|Interferon γ-1b|SC doses of ACTIMMUNE® TIW for a total of 26 weeks.
33875|NCT02415127|P2|Participant Flow|Placebo|SC doses of placebo TIW for a total of 26 weeks.
33876|NCT02415127|P1|Participant Flow|Interferon γ-1b|Subcutaneous (SC) doses of ACTIMMUNE® 3 times a week (TIW) for a total of 26 weeks.
33877|NCT02415127|O2|Outcome|Placebo|SC doses of placebo TIW for a total of 26 weeks.
33878|NCT02415127|O1|Outcome|Interferon γ-1b|SC doses of ACTIMMUNE® TIW for a total of 26 weeks.
33879|NCT02415127|O2|Outcome|Placebo|SC doses of placebo TIW for a total of 26 weeks.
33880|NCT02415127|O1|Outcome|Interferon γ-1b|SC doses of ACTIMMUNE® TIW for a total of 26 weeks.
33881|NCT02415127|O2|Outcome|Placebo|SC doses of placebo TIW for a total of 26 weeks.
33882|NCT02415127|O1|Outcome|Interferon γ-1b|SC doses of ACTIMMUNE® TIW for a total of 26 weeks.
33883|NCT02415127|O2|Outcome|Placebo|SC doses of placebo TIW for a total of 26 weeks.
33884|NCT02415127|O1|Outcome|Interferon γ-1b|SC doses of ACTIMMUNE® TIW for a total of 26 weeks.
33885|NCT02415127|O2|Outcome|Placebo|SC doses of placebo TIW for a total of 26 weeks.
33886|NCT02415127|O1|Outcome|Interferon γ-1b|SC doses of ACTIMMUNE® TIW for a total of 26 weeks.
33887|NCT02415127|E2|Reported Event|Placebo|SC doses of placebo TIW for a total of 26 weeks.
33888|NCT02415127|E1|Reported Event|Interferon γ-1b|SC doses of ACTIMMUNE® TIW for a total of 26 weeks.
33889|NCT02414828|B5|Baseline|Total|Total of all reporting groups
33890|NCT02414828|B4|Baseline|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
33891|NCT02414828|B3|Baseline|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
33892|NCT02414828|B2|Baseline|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
33893|NCT02414828|B1|Baseline|Placebo|Sterile buffer, Intramuscular (IM)
33894|NCT02414828|P4|Participant Flow|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
33895|NCT02414828|P3|Participant Flow|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
33896|NCT02414828|P2|Participant Flow|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
33897|NCT02414828|P1|Participant Flow|Placebo|Sterile buffer, Intramuscular (IM)
33898|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
33899|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
33900|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
33901|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
33902|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
33903|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
33904|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
33905|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
33906|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
33907|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
33908|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
33909|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
33910|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
33911|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
33912|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
33913|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
33914|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
33915|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
33916|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
33917|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
33918|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
33919|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
33920|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
33921|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
33922|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
33923|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
33924|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
33925|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
33926|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
33927|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
33928|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
33929|NCT02414828|O1|Outcome|Placebo|Sterile Buffer, Intramuscular (IM)
33930|NCT02414828|E4|Reported Event|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
33931|NCT02414828|E3|Reported Event|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
33932|NCT02414828|E2|Reported Event|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
33933|NCT02414828|E1|Reported Event|Placebo|Sterile buffer, Intramuscular (IM)
33934|NCT02414152|B1|Baseline|Anakinra|"100mg of Anakinra administered as a daily subcutaneous injection~anakinra: 100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response"
39972|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
33935|NCT02414152|P1|Participant Flow|Anakinra|"100mg of Anakinra administered as a daily subcutaneous injection~anakinra: 100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response"
33936|NCT02414152|O1|Outcome|Anakinra|"100mg of Anakinra administered as a daily subcutaneous injection~anakinra: 100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response"
33937|NCT02414152|E1|Reported Event|Anakinra|"100mg of Anakinra administered as a daily subcutaneous injection~anakinra: 100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response"
33938|NCT02413918|B1|Baseline|Open Label Iloperidone|"open label iloperidone (oral tablet, 6mg-24mg, QD, 20 weeks) as adjunct to current lithium, divalproex, or lamotrigine.~iloperidone: Qualifying subjects will take iloperidone starting at 2mg and up to a minimum of 12mg, maximum of 24mg, for 20 weeks in conjunction to the subjects current lithium, and or divalproex, and or lamotrigine."
33939|NCT02413918|P1|Participant Flow|Open Label Iloperidone|"open label iloperidone (oral tablet, 6mg-24mg, QD, 20 weeks) as adjunct to current lithium, divalproex, or lamotrigine.~iloperidone: Qualifying subjects will take iloperidone starting at 2mg and up to a minimum of 12mg, maximum of 24mg, for 20 weeks in conjunction to the subjects current lithium, and or divalproex, and or lamotrigine."
33940|NCT02413918|O4|Outcome|Mean Change in Mania for All Study Participants|Mean change in mania for all study participants, including early terminators
33941|NCT02413918|O3|Outcome|Mean Change in Depression for All Study Participants|Mean change in depression for all study participants, including early terminators.
33942|NCT02413918|O2|Outcome|Mean Change in Mania for Study Completers|Measurement of mean change in mania for all study participants who completed 20 weeks.
33943|NCT02413918|O1|Outcome|Mean Change in Depression for Study Completers|Measurement of mean change in depression for all subjects who entered study and completed 20 weeks
33944|NCT02413918|E1|Reported Event|Open Label Iloperidone|"open label iloperidone (oral tablet, 6mg-24mg, QD, 20 weeks) as adjunct to current lithium, divalproex, or lamotrigine.~iloperidone: Qualifying subjects will take iloperidone starting at 2mg and up to a minimum of 12mg, maximum of 24mg, for 20 weeks in conjunction to the subjects current lithium, and or divalproex, and or lamotrigine."
33945|NCT02413879|B1|Baseline|Treatment Arm|All study subjects will be treated using the CleanCision device.
33946|NCT02413879|P1|Participant Flow|Treatment Group|All study subjects were treated using the CleanCision device.
33947|NCT02413879|O1|Outcome|Treatment Arm|All study subjects will be treated using the CleanCision device.
33948|NCT02413879|O1|Outcome|Treatment Arm|All study subjects will be treated using the CleanCision device.
33949|NCT02413879|O1|Outcome|Treatment Arm|All study subjects will be treated using the CleanCision device.
33950|NCT02413879|E1|Reported Event|Treatment Arm|All study subjects will be treated using the CleanCision device.
33951|NCT02413593|B1|Baseline|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
33952|NCT02413593|P1|Participant Flow|LDV/SOF+RBV|Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
33953|NCT02413593|O1|Outcome|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
33954|NCT02413593|O1|Outcome|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
33955|NCT02413593|O1|Outcome|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
33956|NCT02413593|O1|Outcome|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
33957|NCT02413593|O1|Outcome|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
33958|NCT02413593|O1|Outcome|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
33959|NCT02413593|E1|Reported Event|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
33960|NCT02413346|B3|Baseline|Total|Total of all reporting groups
33961|NCT02413346|B2|Baseline|Sarecycline/Sarecycline|Participants received sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 mg/kg sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).
33962|NCT02413346|B1|Baseline|Placebo/Sarecycline|Participants received placebo-matching sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 mg/kg sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).
33963|NCT02413346|P2|Participant Flow|Sarecycline/Sarecycline|Participants received sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 mg/kg sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).
33964|NCT02413346|P1|Participant Flow|Placebo/Sarecycline|Participants received placebo-matching sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 milligram(mg)/kilogram(kg) sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).
33965|NCT02413346|O2|Outcome|Sarecycline/Sarecycline|Participants received sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 mg/kg sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).
34262|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
33966|NCT02413346|O1|Outcome|Placebo/Sarecycline|Participants received placebo-matching sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 mg/kg sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).
33967|NCT02413346|E2|Reported Event|Sarecycline/Sarecycline|Participants received sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 mg/kg sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).
33968|NCT02413346|E1|Reported Event|Placebo/Sarecycline|Participants received placebo-matching sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 mg/kg sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).
33969|NCT02413333|B5|Baseline|Total|Total of all reporting groups
33970|NCT02413333|B4|Baseline|PeroxiClear, Then PeroxiClear|PeroxiClear was used in Period 1 and in Period 2.
33971|NCT02413333|B3|Baseline|Clear Care Plus, Then Clear Care Plus|Clear Care Plus was used in Period 1 and in Period 2.
33972|NCT02413333|B2|Baseline|PeroxiClear, Then Clear Care Plus|PeroxiClear was used in Period 1, then Clear Care Plus in Period 2.
33973|NCT02413333|B1|Baseline|Clear Care Plus, Then PeroxiClear|Clear Care Plus was used in Period 1, then PeroxiClear in Period 2.
33974|NCT02413333|P2|Participant Flow|PeroxiClear, Then Clear Care Plus|PeroxiClear contact lens solution in Period 1, followed by Clear Care Plus contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.
33975|NCT02413333|P1|Participant Flow|Clear Care Plus, Then PeroxiClear|Clear Care Plus contact lens solution in Period 1, followed by PeroxiClear contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.
33976|NCT02413333|O2|Outcome|Clear Care Plus|Clear Care Plus Lens Cases
33977|NCT02413333|O1|Outcome|PeroxiClear|PeroxiClear Lens Cases
33978|NCT02413333|O2|Outcome|Clear Care Plus|Clear Care Plus Lens Cases
33979|NCT02413333|O1|Outcome|PeroxiClear|PeroxiClear Lens Cases
33980|NCT02413333|E2|Reported Event|Clear Care Plus|While using Clear Care Plus
33981|NCT02413333|E1|Reported Event|PeroxiClear|While using PeroxiClear
33982|NCT02413294|B1|Baseline|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
33983|NCT02413294|P1|Participant Flow|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
33984|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
33985|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
33986|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
33987|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
34087|NCT02411747|B2|Baseline|Oral Lecture+Simulation Training|"Endoscopic training in flexible cystoscopy by simulation training, max. time cap 1h45min after a 15 minute oral theoretical lecture by a expert in the procedure. Total max. time: 2 hours.~Oral expert lecture Simulation training"
33988|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
33989|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
33990|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
33991|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
33992|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
33993|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
33994|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
33995|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
33996|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
33997|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
33998|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
34328|NCT02409459|O1|Outcome|Injectafer|"15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute~Injectafer"
33999|NCT02413294|E1|Reported Event|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
34000|NCT02413203|B3|Baseline|Total|Total of all reporting groups
34001|NCT02413203|B2|Baseline|Placebo|"Oral administration of a single placebo pill.~Placebo: Blood and urine collections before and 3 hours after placebo administration."
34002|NCT02413203|B1|Baseline|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.~Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
34003|NCT02413203|P2|Participant Flow|Placebo|"Oral administration of a single placebo pill.~Placebo: Blood and urine collections before and 3 hours after placebo administration."
34004|NCT02413203|P1|Participant Flow|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.~Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
34005|NCT02413203|O2|Outcome|Placebo|"Oral administration of a single placebo pill.~Placebo: Blood and urine collections before and 3 hours after placebo administration."
34006|NCT02413203|O1|Outcome|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.~Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
34007|NCT02413203|O2|Outcome|Placebo|"Oral administration of a single placebo pill.~Placebo: Blood and urine collections before and 3 hours after placebo administration."
34008|NCT02413203|O1|Outcome|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.~Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
34009|NCT02413203|O2|Outcome|Placebo|"Oral administration of a single placebo pill.~Placebo: Blood and urine collections before and 3 hours after placebo administration."
34010|NCT02413203|O1|Outcome|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.~Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
34011|NCT02413203|O2|Outcome|Placebo|"Oral administration of a single placebo pill.~Placebo: Blood and urine collections before and 3 hours after placebo administration."
34012|NCT02413203|O1|Outcome|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.~Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
34013|NCT02413203|O2|Outcome|Placebo|"Oral administration of a single placebo pill.~Placebo: Blood and urine collections before and 3 hours after placebo administration."
34014|NCT02413203|O1|Outcome|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.~Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
34015|NCT02413203|O2|Outcome|Placebo|"Oral administration of a single placebo pill.~Placebo: Blood and urine collections before and 3 hours after placebo administration."
34016|NCT02413203|O1|Outcome|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.~Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
34017|NCT02413203|O2|Outcome|Placebo|"Oral administration of a single placebo pill.~Placebo: Blood and urine collections before and 3 hours after placebo administration."
34018|NCT02413203|O1|Outcome|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.~Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
34019|NCT02413203|O2|Outcome|Placebo|"Oral administration of a single placebo pill.~Placebo: Blood and urine collections before and 3 hours after placebo administration."
34020|NCT02413203|O1|Outcome|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.~Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
34021|NCT02413203|E2|Reported Event|Placebo|"Oral administration of a single placebo pill.~Placebo: Blood and urine collections before and 3 hours after placebo administration."
34022|NCT02413203|E1|Reported Event|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.~Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
34023|NCT02413034|B3|Baseline|Total|Total of all reporting groups
34024|NCT02413034|B2|Baseline|Study Group|Cefazolin prophylaxis (vancomycin in the case of allergy to cefazolin)
34025|NCT02413034|B1|Baseline|Control Group|No antibiotic prophylaxis
34026|NCT02413034|P2|Participant Flow|Study Group|Cefazolin: Cefazolin (vancomycin in the case of allergy to cefazolin)
34027|NCT02413034|P1|Participant Flow|Control Group|No antibiotic prophylaxis
34028|NCT02413034|O2|Outcome|Study Group|Cefazolin prophylaxis (vancomycin in the case of allergy to cefazolin)
34029|NCT02413034|O1|Outcome|Control Group|No antibiotic prophylaxis
34030|NCT02413034|O2|Outcome|Study Group|Cefazolin prophylaxis (vancomycin in the case of allergy to cefazolin)
34031|NCT02413034|O1|Outcome|Control Group|No antibiotic prophylaxis
34032|NCT02413034|E2|Reported Event|Study Group|Cefazolin prophylaxis (vancomycin in the case of allergy to cefazolin)
34033|NCT02413034|E1|Reported Event|Control Group|No antibiotic prophylaxis
34034|NCT02412657|B4|Baseline|Total|Total of all reporting groups
34035|NCT02412657|B3|Baseline|Normal Saline 20 mL Intravenous|"Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Normal Saline"
34263|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
34036|NCT02412657|B2|Baseline|Dexamethasone 4 mg Intravenous|"Dexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
34037|NCT02412657|B1|Baseline|Dexamethasone 10 mg Intravenous|"Dexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
34038|NCT02412657|P3|Participant Flow|Normal Saline 20 mL Intravenous|"Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Normal Saline"
34039|NCT02412657|P2|Participant Flow|Dexamethasone 4 mg Intravenous|"Dexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
34040|NCT02412657|P1|Participant Flow|Dexamethasone 10 mg Intravenous|"Dexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
34041|NCT02412657|O3|Outcome|Normal Saline 20 mL Intravenous|"Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Normal Saline"
34042|NCT02412657|O2|Outcome|Dexamethasone 4 mg Intravenous|"Dexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
34043|NCT02412657|O1|Outcome|Dexamethasone 10 mg Intravenous|"Dexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
34044|NCT02412657|E3|Reported Event|Normal Saline 20 mL Intravenous|"Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Normal Saline"
34045|NCT02412657|E2|Reported Event|Dexamethasone 4 mg Intravenous|"Dexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
34046|NCT02412657|E1|Reported Event|Dexamethasone 10 mg Intravenous|"Dexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
34047|NCT02412501|B1|Baseline|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System >~> Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent"
34048|NCT02412501|P1|Participant Flow|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System >~> Resolute Onyx Stent - 2.0 mm"
34049|NCT02412501|O1|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent >~> Resolute Onyx Stent - 2.0 mm: Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent"
34050|NCT02412501|O1|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent >~> Resolute Onyx Stent - 2.0 mm: Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent"
34051|NCT02412501|O1|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent >~> Resolute Onyx Stent - 2.0 mm: Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent"
34052|NCT02412501|O1|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent >~> Resolute Onyx Stent - 2.0 mm: Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent"
34053|NCT02412501|O1|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent >~> Resolute Onyx Stent - 2.0 mm: Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent"
34054|NCT02412501|O1|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent >~> Resolute Onyx Stent - 2.0 mm: Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent"
34055|NCT02412501|E1|Reported Event|1. Onyx 2.0mm|Medtronic Onyx 2.0mm
34056|NCT02411929|B1|Baseline|Ertugliflozin|Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. The 14^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose. → Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. Both the unlabeled and 14^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart). Dosing in Periods 1 and 2 will be separated by a washout of at least 11 days.
34085|NCT02411929|E1|Reported Event|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug IV|Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. The 14^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose.
34057|NCT02411929|P1|Participant Flow|Ertugliflozin|Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. The 14^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose. → Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. Both the unlabeled and 14^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart). Dosing in Periods 1 and 2 will be separated by a washout of at least 11 days.
34058|NCT02411929|O2|Outcome|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug Oral|Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. Both the unlabeled and 14^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart).
34059|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug IV|Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. The 14^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose.
34060|NCT02411929|O2|Outcome|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug Oral|Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. Both the unlabeled and 14^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart).
34061|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug IV|Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. The 14^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose.
34062|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
34063|NCT02411929|O1|Outcome|14^C-Ertugliflozin 100 ug Oral|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C administered orally after the unlabeled oral dose (no more than 5 minutes apart) on Day 1 of Period 2.
34064|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
34065|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
34066|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
34067|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
34068|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
34069|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
34070|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
34071|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
34072|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
34073|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
34074|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
34075|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
34076|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
34077|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
34078|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
34079|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
34080|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
34081|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
34082|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
34083|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
34084|NCT02411929|E2|Reported Event|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug Oral|Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. Both the unlabeled and 14^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart.)
34086|NCT02411747|B3|Baseline|Total|Total of all reporting groups
34264|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
34088|NCT02411747|B1|Baseline|Directed Self-regulated Simulation Training+Testing|"Endoscopic training in flexible cystoscopy by directed self-regulated training with knowledge of a test afterwards, max. time cap 1h45min. 15 minutes of testing with a expert in the procedure. Total max time: 2 hours.~Directed self-regulated simulation training Testing"
34089|NCT02411747|P2|Participant Flow|Oral Lecture+Simulation Training|"Endoscopic training in flexible cystoscopy simulation training, max. time cap 1h45min after a 15 minute oral theoretical lecture by an expert in the procedure. Total max. time: 2 hours.~Oral expert lecture Simulation training"
34090|NCT02411747|P1|Participant Flow|Directed Self-regulated Simulation Training+Testing|"Endoscopic training in flexible cystoscopy by directed self-regulated training with knowledge of a test afterwards, max. time cap 1h45min. 15 minutes of testing with an expert in the procedure. Total max time: 2 hours.~Directed self-regulated simulation training Testing"
34091|NCT02411747|O2|Outcome|Oral Lecture+Simulation Training|"Endoscopic training in flexible cystoscopy simulation training, max. time cap 1h45min after a 15 minute oral theoretical lecture by an expert in the procedure. Total max. time: 2 hours.~Oral expert lecture Simulation training"
34092|NCT02411747|O1|Outcome|Directed Self-regulated Simulation Training+Testing|"Endoscopic training in flexible cystoscopy by directed self-regulated training with knowledge of a test afterwards, max. time cap 1h45min. 15 minutes of testing with an expert in the procedure. Total max time: 2 hours.~Directed self-regulated simulation training Testing"
34093|NCT02411747|E2|Reported Event|Oral Lecture+Simulation Training|"Endoscopic training in flexible cystoscopy simulation training, max. time cap 1h45min after a 15 minute oral theoretical lecture by an expert in the procedure. Total max. time: 2 hours.~Oral expert lecture Simulation training"
34094|NCT02411747|E1|Reported Event|Directed Self-regulated Simulation Training+Testing|"Endoscopic training in flexible cystoscopy by directed self-regulated training with knowledge of a test afterwards, max. time cap 1h45min. 15 minutes of testing with an expert in the procedure. Total max time: 2 hours.~Directed self-regulated simulation training Testing"
34095|NCT02411578|B3|Baseline|Total|Total of all reporting groups
34096|NCT02411578|B2|Baseline|Glucose Tabs, Then G-Pen Mini|"For Glucose Tabs Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~Glucose Tabs: 1st BG check, 1st treatment:~BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates~BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70 mg/dl, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34097|NCT02411578|B1|Baseline|G-Pen Mini™ (Glucagon Injection), Then Glucose Tabs|"For G-Pen Mini Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment~BG is 50-69 mg/dl, treatment is 150 µg of glucagon~BG is 40-49 mg/dl, treatment is 300 µg of glucagon~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 150 µg of glucagon~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34098|NCT02411578|P2|Participant Flow|Glucose Tabs, Then G-Pen Mini|"For Glucose Tabs Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~Glucose Tabs: 1st BG check, 1st treatment:~BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates~BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70 mg/dl, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34099|NCT02411578|P1|Participant Flow|G-Pen Mini™ (Glucagon Injection), Then Glucose Tabs|"For G-Pen Mini Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment~BG is 50-69 mg/dl, treatment is 150 µg of glucagon~BG is 40-49 mg/dl, treatment is 300 µg of glucagon~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 150 µg of glucagon~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34100|NCT02411578|O2|Outcome|Glucose Tabs|"For Glucose Tabs Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~Glucose Tabs: 1st BG check, 1st treatment:~BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates~BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70 mg/dl, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34149|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34329|NCT02409459|O2|Outcome|Placebo|"15 cc of Normal Saline IV push at 2 ml/minute~Normal Saline"
34101|NCT02411578|O1|Outcome|G-Pen Mini™ (Glucagon Injection)|"For G-Pen Mini Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment~BG is 50-69 mg/dl, treatment is 150 µg of glucagon~BG is 40-49 mg/dl, treatment is 300 µg of glucagon~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 150 µg of glucagon~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34102|NCT02411578|O2|Outcome|Glucose Tabs|"For Glucose Tabs Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~Glucose Tabs: 1st BG check, 1st treatment:~BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates~BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70 mg/dl, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34103|NCT02411578|O1|Outcome|G-Pen Mini™ (Glucagon Injection)|"For G-Pen Mini Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment~BG is 50-69 mg/dl, treatment is 150 µg of glucagon~BG is 40-49 mg/dl, treatment is 300 µg of glucagon~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 150 µg of glucagon~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34104|NCT02411578|O2|Outcome|Glucose Tabs|"For Glucose Tabs Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~Glucose Tabs: 1st BG check, 1st treatment:~BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates~BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70 mg/dl, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34105|NCT02411578|O1|Outcome|G-Pen Mini™ (Glucagon Injection)|"For G-Pen Mini Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment~BG is 50-69 mg/dl, treatment is 150 µg of glucagon~BG is 40-49 mg/dl, treatment is 300 µg of glucagon~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 150 µg of glucagon~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34106|NCT02411578|O2|Outcome|Glucose Tabs|"For Glucose Tabs Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~Glucose Tabs: 1st BG check, 1st treatment:~BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates~BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70 mg/dl, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34107|NCT02411578|O1|Outcome|G-Pen Mini™ (Glucagon Injection)|"For G-Pen Mini Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment~BG is 50-69 mg/dl, treatment is 150 µg of glucagon~BG is 40-49 mg/dl, treatment is 300 µg of glucagon~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 150 µg of glucagon~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34108|NCT02411578|O2|Outcome|Glucose Tabs|"For Glucose Tabs Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~Glucose Tabs: 1st BG check, 1st treatment:~BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates~BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70 mg/dl, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34253|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
35787|NCT02394756|E1|Reported Event|Senofilcon A|Subjects wore the senofilcon A lens in any of the three periods during the study.
34109|NCT02411578|O1|Outcome|G-Pen Mini™ (Glucagon Injection)|"For G-Pen Mini Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment~BG is 50-69 mg/dl, treatment is 150 µg of glucagon~BG is 40-49 mg/dl, treatment is 300 µg of glucagon~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 150 µg of glucagon~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34110|NCT02411578|O2|Outcome|Glucose Tabs|"For Glucose Tabs Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~Glucose Tabs: 1st BG check, 1st treatment:~BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates~BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70 mg/dl, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34111|NCT02411578|O1|Outcome|G-Pen Mini™ (Glucagon Injection)|"For G-Pen Mini Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment~BG is 50-69 mg/dl, treatment is 150 µg of glucagon~BG is 40-49 mg/dl, treatment is 300 µg of glucagon~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 150 µg of glucagon~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34112|NCT02411578|O2|Outcome|Glucose Tabs|"For Glucose Tabs Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~Glucose Tabs: 1st BG check, 1st treatment:~BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates~BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70 mg/dl, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34113|NCT02411578|O1|Outcome|G-Pen Mini™ (Glucagon Injection)|"For G-Pen Mini Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment~BG is 50-69 mg/dl, treatment is 150 µg of glucagon~BG is 40-49 mg/dl, treatment is 300 µg of glucagon~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 150 µg of glucagon~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34114|NCT02411578|O2|Outcome|Glucose Tabs|"For Glucose Tabs Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~Glucose Tabs: 1st BG check, 1st treatment:~BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates~BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70 mg/dl, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34115|NCT02411578|O1|Outcome|G-Pen Mini™ (Glucagon Injection)|"For G-Pen Mini Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment~BG is 50-69 mg/dl, treatment is 150 µg of glucagon~BG is 40-49 mg/dl, treatment is 300 µg of glucagon~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 150 µg of glucagon~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34116|NCT02411578|O2|Outcome|Glucose Tabs|"For Glucose Tabs Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~Glucose Tabs: 1st BG check, 1st treatment:~BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates~BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70 mg/dl, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34254|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
35788|NCT02394665|B4|Baseline|Total|Total of all reporting groups
34117|NCT02411578|O1|Outcome|G-Pen Mini™ (Glucagon Injection)|"For G-Pen Mini Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment~BG is 50-69 mg/dl, treatment is 150 µg of glucagon~BG is 40-49 mg/dl, treatment is 300 µg of glucagon~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 150 µg of glucagon~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34118|NCT02411578|O2|Outcome|Glucose Tabs|"For Glucose Tabs Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~Glucose Tabs: 1st BG check, 1st treatment:~BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates~BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70 mg/dl, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34119|NCT02411578|O1|Outcome|G-Pen Mini™ (Glucagon Injection)|"For G-Pen Mini Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment~BG is 50-69 mg/dl, treatment is 150 µg of glucagon~BG is 40-49 mg/dl, treatment is 300 µg of glucagon~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 150 µg of glucagon~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34120|NCT02411578|O2|Outcome|Glucose Tabs|"For Glucose Tabs Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~Glucose Tabs: 1st BG check, 1st treatment:~BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates~BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70 mg/dl, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34121|NCT02411578|O1|Outcome|G-Pen Mini™ (Glucagon Injection)|"For G-Pen Mini Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment~BG is 50-69 mg/dl, treatment is 150 µg of glucagon~BG is 40-49 mg/dl, treatment is 300 µg of glucagon~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 150 µg of glucagon~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34122|NCT02411578|O2|Outcome|Glucose Tabs|"For Glucose Tabs Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~Glucose Tabs: 1st BG check, 1st treatment:~BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates~BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70 mg/dl, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34123|NCT02411578|O1|Outcome|G-Pen Mini™ (Glucagon Injection)|"For G-Pen Mini Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment~BG is 50-69 mg/dl, treatment is 150 µg of glucagon~BG is 40-49 mg/dl, treatment is 300 µg of glucagon~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 150 µg of glucagon~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34124|NCT02411578|O2|Outcome|Glucose Tabs|"For Glucose Tabs Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~Glucose Tabs: 1st BG check, 1st treatment:~BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates~BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70 mg/dl, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34255|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
35851|NCT02393950|O6|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10mg ODM-106 Capsule B
34125|NCT02411578|O1|Outcome|G-Pen Mini™ (Glucagon Injection)|"For G-Pen Mini Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment~BG is 50-69 mg/dl, treatment is 150 µg of glucagon~BG is 40-49 mg/dl, treatment is 300 µg of glucagon~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 150 µg of glucagon~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34126|NCT02411578|O2|Outcome|Glucose Tabs|"For Glucose Tabs Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~Glucose Tabs: 1st BG check, 1st treatment:~BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates~BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70 mg/dl, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34127|NCT02411578|O1|Outcome|G-Pen Mini™ (Glucagon Injection)|"For G-Pen Mini Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment~BG is 50-69 mg/dl, treatment is 150 µg of glucagon~BG is 40-49 mg/dl, treatment is 300 µg of glucagon~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 150 µg of glucagon~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34128|NCT02411578|O2|Outcome|Glucose Tabs|"For Glucose Tabs Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~Glucose Tabs: 1st BG check, 1st treatment:~BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates~BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70 mg/dl, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34129|NCT02411578|O1|Outcome|G-Pen Mini™ (Glucagon Injection)|"For G-Pen Mini Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment~BG is 50-69 mg/dl, treatment is 150 µg of glucagon~BG is 40-49 mg/dl, treatment is 300 µg of glucagon~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 150 µg of glucagon~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34130|NCT02411578|O2|Outcome|Glucose Tabs|"For Glucose Tabs Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~Glucose Tabs: 1st BG check, 1st treatment:~BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates~BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70 mg/dl, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34131|NCT02411578|O1|Outcome|G-Pen Mini™ (Glucagon Injection)|"For G-Pen Mini Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment~BG is 50-69 mg/dl, treatment is 150 µg of glucagon~BG is 40-49 mg/dl, treatment is 300 µg of glucagon~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 150 µg of glucagon~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34132|NCT02411578|O2|Outcome|Glucose Tabs|"For Glucose Tabs Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~Glucose Tabs: 1st BG check, 1st treatment:~BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates~BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70 mg/dl, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34256|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
35852|NCT02393950|O5|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100mg ODM-106 Capsule B
34133|NCT02411578|O1|Outcome|G-Pen Mini™ (Glucagon Injection)|"For G-Pen Mini Period:~Participants are to check blood glucose (BG) with study BG meter (BGM) if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment~BG is 50-69 mg/dl, treatment is 150 µg of glucagon~BG is 40-49 mg/dl, treatment is 300 µg of glucagon~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 150 µg of glucagon~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34134|NCT02411578|O2|Outcome|Glucose Tabs|"For Glucose Tabs Period:~Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~Glucose Tabs: 1st BG check, 1st treatment:~BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates~BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70 mg/dl, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34135|NCT02411578|O1|Outcome|G-Pen Mini™ (Glucagon Injection)|"For G-Pen Mini period:~Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).~G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment~BG is 50-69 mg/dl, treatment is 150 µg of glucagon~BG is 40-49 mg/dl, treatment is 300 µg of glucagon~15 min later, 2nd BG check, 2nd treatment~BG is 60-69 mg/dl, no treatment~BG is 50-59 mg/dl, treatment is 150 µg of glucagon~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~BG is >=70, no treatment~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon"
34136|NCT02411578|E2|Reported Event|Glucose Tabs|Participants treat non-severe hypoglycemic events with glucose tabs.
34137|NCT02411578|E1|Reported Event|G-Pen Mini™ (Glucagon Injection)|Participants treat non-severe hypoglycemic events with glucagon.
34138|NCT02411539|B3|Baseline|Total|Total of all reporting groups
34139|NCT02411539|B2|Baseline|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34140|NCT02411539|B1|Baseline|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34141|NCT02411539|P2|Participant Flow|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34142|NCT02411539|P1|Participant Flow|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34143|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo (normal saline) at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34144|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo (normal saline) at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34145|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34146|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34147|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34148|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34257|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
34316|NCT02409459|P1|Participant Flow|Injectafer|"15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute~Injectafer"
34150|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34151|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34152|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34153|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34154|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34155|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34156|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34157|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34158|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34159|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo (normal saline) at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34160|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo (normal saline) at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34161|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo (normal saline) at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34162|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo (normal saline) at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34163|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo (normal saline) at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34164|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo (normal saline) at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34165|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34166|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34167|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34317|NCT02409459|O2|Outcome|Placebo|"15 cc of Normal Saline IV push at 2 ml/minute~Normal Saline"
39973|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
34168|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34169|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34170|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34171|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34172|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34173|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34174|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34175|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34176|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34177|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34178|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34179|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34180|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34181|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34182|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34183|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34184|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34185|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34258|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
39974|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
34186|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34187|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34188|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34189|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34190|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34191|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34192|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34193|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34194|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34195|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34196|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34197|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34198|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34199|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34200|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34201|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34202|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34203|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34259|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
39975|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
34204|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34205|NCT02411539|O1|Outcome|Across Arms|Compare the pre-VRC01 and post-VRC01 time points across randomized Arms A/B. Arm A participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. Arm B participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. This group is to identify analyses that were assessed across randomized arms between the pre- and post-VRC01 time points.
34206|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34207|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34208|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34209|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34210|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34211|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34212|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34213|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump~Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34214|NCT02411539|E2|Reported Event|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34215|NCT02411539|E1|Reported Event|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.~VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
34216|NCT02411292|B1|Baseline|Enoxaparin Metabolism|"Eligible patients will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.~Enoxaparin: Enrolled patients will receive real-time monitoring of peak and trough steady state anti-Xa levels. Out-of-range patients will receive real time dose adjustment using a clinical protocol developed with our inpatient pharmacists."
34217|NCT02411292|P1|Participant Flow|Enoxaparin Metabolism|"Eligible patients will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.~Enoxaparin: Enrolled patients will receive real-time monitoring of peak and trough steady state anti-Xa levels. Out-of-range patients will receive real time dose adjustment using a clinical protocol developed with our inpatient pharmacists."
34218|NCT02411292|O1|Outcome|Enoxaparin Metabolism|Eligible patients will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.
34219|NCT02411292|O2|Outcome|In-Range or High aFXa Level|Patients with an in-range or high Anti-Factor Xa Level as identified after the third administration of enoxaparin
34220|NCT02411292|O1|Outcome|Low aFXa Level|Patients with a low Anti-Factor Xa Level as identified after the third administration of enoxaparin
34260|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
34261|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
35853|NCT02393950|O4|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10mg ODM-106 Capsule B
34221|NCT02411292|E1|Reported Event|Enoxaparin Metabolism|"Eligible patients will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.~Enoxaparin: Enrolled patients will receive real-time monitoring of peak and trough steady state anti-Xa levels. Out-of-range patients will receive real time dose adjustment using a clinical protocol developed with our inpatient pharmacists."
34222|NCT02411201|B1|Baseline|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
34223|NCT02411201|P1|Participant Flow|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
34224|NCT02411201|O2|Outcome|Pre- + Post-contrast|Lesion visualization was assessed after DOTAREM injection
34225|NCT02411201|O1|Outcome|Pre-contrast|Lesion visualization was assessed before DOTAREM injection
34226|NCT02411201|O1|Outcome|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
34227|NCT02411201|O1|Outcome|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
34228|NCT02411201|O1|Outcome|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
34229|NCT02411201|O1|Outcome|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
34230|NCT02411201|O1|Outcome|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
34231|NCT02411201|O1|Outcome|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
34232|NCT02411201|E1|Reported Event|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
34233|NCT02411110|B3|Baseline|Total|Total of all reporting groups
34234|NCT02411110|B2|Baseline|LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2)|Treatment Period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
34235|NCT02411110|B1|Baseline|LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2)|Treatment Period 1: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional LiRIS® inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
34236|NCT02411110|P2|Participant Flow|LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2)|Treatment Period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
34237|NCT02411110|P1|Participant Flow|LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2)|Treatment Period 1: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional LiRIS® inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
34238|NCT02411110|O2|Outcome|LiRIS Placebo (Treatment Period 1)|Treatment Period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1.
34239|NCT02411110|O1|Outcome|LiRIS® (Treatment Period 1)|Treatment Period 1: LiRIS® (continuous release of lidocaine ) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1.
34240|NCT02411110|E4|Reported Event|LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2)|Participants who received LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1; followed by, LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
34241|NCT02411110|E3|Reported Event|LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2)|Participants who received Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1; followed by, LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
34242|NCT02411110|E2|Reported Event|LiRIS® (Treatment Period 1)|Treatment Period 1: LiRIS® (continuous release of lidocaine ) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1.
34243|NCT02411110|E1|Reported Event|LiRIS Placebo (Treatment Period 1)|Treatment Period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1.
34244|NCT02410824|B1|Baseline|Overall Baseline Characteristics|Participants were randomized to wear stenfilcon A toric lens or etafilcon A toric lens bilaterally for one week, then cross over to the alternative pair.
34245|NCT02410824|P2|Participant Flow|Etafilcon A Toric Lens, Then Stenfilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week, then cross over to the stenfilcon A toric lens.~etafilcon A: toric contact lens~stenfilcon A: toric contact lens"
34246|NCT02410824|P1|Participant Flow|Stenfilcon A Toric Lens, Then Etafilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week, then cross over to the etafilcon A toric lens.~stenfilcon A: toric contact lens~etafilcon A: toric contact lens"
34247|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
34248|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
34249|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
34250|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
34251|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
34252|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
39976|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
34265|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
34266|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
34267|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
34268|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric lens contact lens"
34269|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
34270|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
34271|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
34272|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
34273|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
34274|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
34275|NCT02410824|E2|Reported Event|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
34276|NCT02410824|E1|Reported Event|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
34277|NCT02410291|B3|Baseline|Total|Total of all reporting groups
34278|NCT02410291|B2|Baseline|Control Group|Patients in this group will receive the standard care to prepare them for their planning CT scan. They will be presented with the flyer at the consultation. A few days before the CT appointment, patients in this group will also be called and reminded about the required preparations, but will not be told about the video. In addition to the statistics about patient preparedness collected by the radiation therapist conducting the CT scan and stored and secured in an OCC Pinnacle planning system, we will also evaluate: patients’ satisfaction with the preparation instructions, their knowledge (knowledge questionnaire) about the video content and importance of understanding the rectal emptying procedures, and radiation therapists’ satisfaction with patients’ rectal preparation.
34279|NCT02410291|B1|Baseline|Experimental Group|"Patients will receive the standard are to prepare them for their planning CT scan. They will be presented with the flyer that will be developed based on information about the importance of rectal and bladder preparation that is currently provided to patients and will also watch a youtube video on how to prepare for their CT simulation appointment. A few days before the CT planning appointment, patients in this group will be called by the radiation therapist or RA, reminding them about the rectal preparation for the appointment. Each patient will also be reminded to watch the instructional video on YouTube. Patients will be asked not to share the video link with other patients during the study.~Educational video: Patients in the control group will receive standard patient education Patients in the experimental group will receive standard education and an educational video"
34280|NCT02410291|P2|Participant Flow|Control Group|Patients in this group will receive the standard care to prepare them for their planning CT scan. They will be presented with the flyer at the consultation. A few days before the CT appointment, patients in this group will also be called and reminded about the required preparations, but will not be told about the video. In addition to the statistics about patient preparedness collected by the radiation therapist conducting the CT scan and stored and secured in an OCC Pinnacle planning system, we will also evaluate: patients’ satisfaction with the preparation instructions, their knowledge (knowledge questionnaire) about the video content and importance of understanding the rectal emptying procedures, and radiation therapists’ satisfaction with patients’ rectal preparation.
34281|NCT02410291|P1|Participant Flow|Experimental Group|"Patients will receive the standard are to prepare them for their planning CT scan. They will be presented with the flyer that will be developed based on information about the importance of rectal and bladder preparation that is currently provided to patients and will also watch a youtube video on how to prepare for their CT simulation appointment. A few days before the CT planning appointment, patients in this group will be called by the radiation therapist or RA, reminding them about the rectal preparation for the appointment. Each patient will also be reminded to watch the instructional video on YouTube. Patients will be asked not to share the video link with other patients during the study.~Educational video: Patients in the control group will receive standard patient education Patients in the experimental group will receive standard education and an educational video"
34282|NCT02410291|O2|Outcome|Control Group|Patients in this group will receive the standard care to prepare them for their planning CT scan. They will be presented with the flyer at the consultation. A few days before the CT appointment, patients in this group will also be called and reminded about the required preparations, but will not be told about the video. In addition to the statistics about patient preparedness collected by the radiation therapist conducting the CT scan and stored and secured in an OCC Pinnacle planning system, we will also evaluate: patients’ satisfaction with the preparation instructions, their knowledge (knowledge questionnaire) about the video content and importance of understanding the rectal emptying procedures, and radiation therapists’ satisfaction with patients’ rectal preparation.
34318|NCT02409459|O1|Outcome|Injectafer|"15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute~Injectafer"
34319|NCT02409459|O2|Outcome|Placebo|"15 cc of Normal Saline IV push at 2 ml/minute~Normal Saline"
34320|NCT02409459|O1|Outcome|Injectafer|"15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute~Injectafer"
34321|NCT02409459|O2|Outcome|Placebo|"15 cc of Normal Saline IV push at 2 ml/minute~Normal Saline"
34322|NCT02409459|O1|Outcome|Injectafer|"15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute~Injectafer"
34283|NCT02410291|O1|Outcome|Experimental Group|"Patients will receive the standard are to prepare them for their planning CT scan. They will be presented with the flyer that will be developed based on information about the importance of rectal and bladder preparation that is currently provided to patients and will also watch a youtube video on how to prepare for their CT simulation appointment. A few days before the CT planning appointment, patients in this group will be called by the radiation therapist or RA, reminding them about the rectal preparation for the appointment. Each patient will also be reminded to watch the instructional video on YouTube. Patients will be asked not to share the video link with other patients during the study.~Educational video: Patients in the control group will receive standard patient education Patients in the experimental group will receive standard education and an educational video"
34284|NCT02410291|E2|Reported Event|Control Group|Patients in this group will receive the standard care to prepare them for their planning CT scan. They will be presented with the flyer at the consultation. A few days before the CT appointment, patients in this group will also be called and reminded about the required preparations, but will not be told about the video. In addition to the statistics about patient preparedness collected by the radiation therapist conducting the CT scan and stored and secured in an OCC Pinnacle planning system, we will also evaluate: patients’ satisfaction with the preparation instructions, their knowledge (knowledge questionnaire) about the video content and importance of understanding the rectal emptying procedures, and radiation therapists’ satisfaction with patients’ rectal preparation.
34285|NCT02410291|E1|Reported Event|Experimental Group|"Patients will receive the standard are to prepare them for their planning CT scan. They will be presented with the flyer that will be developed based on information about the importance of rectal and bladder preparation that is currently provided to patients and will also watch a youtube video on how to prepare for their CT simulation appointment. A few days before the CT planning appointment, patients in this group will be called by the radiation therapist or RA, reminding them about the rectal preparation for the appointment. Each patient will also be reminded to watch the instructional video on YouTube. Patients will be asked not to share the video link with other patients during the study.~Educational video: Patients in the control group will receive standard patient education Patients in the experimental group will receive standard education and an educational video"
34286|NCT02410213|B1|Baseline|Ferric Carboxymaltose (FCM)|"FCM at 7.5 mg/kg or 15 mg/kg to a maximum single dose of 750 mg iron, whichever is smaller~Ferric Carboxymaltose (FCM)"
34287|NCT02410213|P2|Participant Flow|Cohort 2: Ferric Carboxymaltose (FCM) 15 mg/kg|FCM at 15mg/kg to a maximum single dose of 750mg iron, whichever is smaller
34288|NCT02410213|P1|Participant Flow|Cohort 1: Ferric Carboxymaltose (FCM) 7.5 mg/kg|"FCM at 7.5 mg/kg to a maximum single dose of 750 mg iron, whichever is smaller~Ferric Carboxymaltose (FCM)"
34289|NCT02410213|O2|Outcome|Cohort 2: Ferric Carboxymaltose (FCM) 15 mg/kg|FCM at 15 mg/kg to a maximum single dose of 750 mg iron, whichever is smaller
34290|NCT02410213|O1|Outcome|Cohort 1: Ferric Carboxymaltose (FCM) 7.5 mg|"FCM at 7.5 mg/kg to a maximum single dose of 750 mg iron, whichever is smaller~Ferric Carboxymaltose (FCM)"
34291|NCT02410213|E2|Reported Event|Cohort 2: Ferric Carboxymaltose (FCM) 15 mg/kg|"FCM at 15 mg/kg to a maximum single dose of 750 mg iron, whichever is smaller~Ferric Carboxymaltose (FCM)"
34292|NCT02410213|E1|Reported Event|Cohort 1: Ferric Carboxymaltose (FCM) 7.5 mg/kg|"FCM at 7.5 mg/kg to a maximum single dose of 750 mg iron, whichever is smaller~Ferric Carboxymaltose (FCM)"
34293|NCT02410200|B1|Baseline|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
34294|NCT02410200|P1|Participant Flow|BG00012|BG00012 taken orally at a dose of 120 mg twice daily (BID) for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
34295|NCT02410200|O1|Outcome|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
34296|NCT02410200|O1|Outcome|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
34297|NCT02410200|O1|Outcome|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
34298|NCT02410200|O1|Outcome|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
34299|NCT02410200|O1|Outcome|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
34300|NCT02410200|O1|Outcome|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
34301|NCT02410200|O1|Outcome|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
34302|NCT02410200|O1|Outcome|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
34303|NCT02410200|E1|Reported Event|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
34304|NCT02409784|B1|Baseline|Healthy Adults|Healthy adults were recruited to do the control PET scan follow by a 4 days ketogenic diet intervention and ending with an other PET scan post diet.
34305|NCT02409784|P1|Participant Flow|Healthy Adults|Healthy adults were recruited to do the control PET scan follow by a 4 days ketogenic diet intervention and ending with an other PET scan post diet.
34306|NCT02409784|O2|Outcome|Ketogenic Diet|"TEP study with a 4 days ketogenic diet~Ketogenic diet: 4 days 4:1 (lipids:protein/carbohydrates) ketogenic diet"
34307|NCT02409784|O1|Outcome|Control|TEP study without any intervention
34308|NCT02409784|O2|Outcome|Ketogenic Diet|"TEP study with a 4 days ketogenic diet~Ketogenic diet: 4 days 4:1 (lipids:protein/carbohydrates) ketogenic diet"
34309|NCT02409784|O1|Outcome|Control|TEP study without any intervention
34310|NCT02409784|E2|Reported Event|Ketogenic Diet|"TEP study with a 4 days ketogenic diet~Ketogenic diet: 4 days 4:1 (lipids:protein/carbohydrates) ketogenic diet"
34311|NCT02409784|E1|Reported Event|Control|TEP study without any intervention
34312|NCT02409459|B3|Baseline|Total|Total of all reporting groups
34313|NCT02409459|B2|Baseline|Injectafer|Group A: Injectafer
34314|NCT02409459|B1|Baseline|Placebo|Group B: Placebo
34315|NCT02409459|P2|Participant Flow|Placebo|"15 cc of Normal Saline IV push at 2 ml/minute~Normal Saline"
34330|NCT02409459|O1|Outcome|Injectafer|"15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute~Injectafer"
34331|NCT02409459|E2|Reported Event|Placebo|"15 cc of Normal Saline IV push at 2 ml/minute~Placebo: Normal saline solution"
34332|NCT02409459|E1|Reported Event|Injectafer|"15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute~Injectafer"
34333|NCT02408692|B4|Baseline|Total|Total of all reporting groups
34334|NCT02408692|B3|Baseline|Obese BMI ECx2|"5 obese women (BMI >30 kg/m2) taking 3mg LNG~ECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)"
34335|NCT02408692|B2|Baseline|Obese BMI ECx1|"5 obese women (BMI >30 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
34336|NCT02408692|B1|Baseline|Normal BMI ECx1|"5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
34337|NCT02408692|P3|Participant Flow|Obese BMI ECx2|"5 obese women (BMI >30 kg/m2) taking 3mg LNG~ECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)"
34338|NCT02408692|P2|Participant Flow|Obese BMI ECx1|"5 obese women (BMI >30 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
34339|NCT02408692|P1|Participant Flow|Normal BMI ECx1|"5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
34340|NCT02408692|O3|Outcome|Obese BMI ECx2|"5 obese women (BMI >30 kg/m2) taking 3mg LNG~ECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)"
34341|NCT02408692|O2|Outcome|Obese BMI ECx1|"5 obese women (BMI >30 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
34342|NCT02408692|O1|Outcome|Normal BMI ECx1|"5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
34343|NCT02408692|O3|Outcome|Obese BMI ECx2|"5 obese women (BMI >30 kg/m2) taking 3mg LNG~ECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)"
34344|NCT02408692|O2|Outcome|Obese BMI ECx1|"5 obese women (BMI >30 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
34345|NCT02408692|O1|Outcome|Normal BMI ECx1|"5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
34346|NCT02408692|E3|Reported Event|Obese BMI ECx2|"5 obese women (BMI >30 kg/m2) taking 3mg LNG~ECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)"
34347|NCT02408692|E2|Reported Event|Obese BMI ECx1|"5 obese women (BMI >30 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
34348|NCT02408692|E1|Reported Event|Normal BMI ECx1|"5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
34349|NCT02408263|B1|Baseline|THR and TKR|
34350|NCT02408263|P1|Participant Flow|THR and TKR|
34351|NCT02408263|O1|Outcome|Total Hip Replacement (THR) and Total Knee Replacement (TKR)|"25 patients receiving a Total Hip Replacement and 25 patients receiving a Total Knee Replacement. The investigators are using Skin Conductance Algesimeter (SCA) to measure pain by analyzing changes in skin conductance.~THR and TKR: Total Hip Replacement is a surgical procedure whereby the diseased cartilage and bone of the hip joint is surgically replaced with artificial materials. Total Knee Replacement is a procedure which involves replacement of all three compartments of the knee (the medial compartment (inside aspect of the knee), the lateral compartment (outside of the knee) and the patellofemoral compartment (in front of the knee))."
34454|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
34455|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
39977|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
34352|NCT02408263|O1|Outcome|Total Hip Replacement (THR) and Total Knee Replacement (TKR)|"25 patients receiving a Total Hip Replacement and 25 patients receiving a Total Knee Replacement. The investigators are using Skin Conductance Algesimeter (SCA) to measure pain by analyzing changes in skin conductance.~THR and TKR: Total Hip Replacement is a surgical procedure whereby the diseased cartilage and bone of the hip joint is surgically replaced with artificial materials. Total Knee Replacement is a procedure which involves replacement of all three compartments of the knee (the medial compartment (inside aspect of the knee), the lateral compartment (outside of the knee) and the patellofemoral compartment (in front of the knee))."
34353|NCT02408263|O1|Outcome|THR and TKR|
34354|NCT02408263|E1|Reported Event|THR and TKR|
34355|NCT02408068|B1|Baseline|All Study Participants|All patients received all 3 study treatments in randomised order
34356|NCT02408068|P6|Participant Flow|Sequence 6|Hydrocortisone 20mg (fasted), Chronocort 20mg (fasted), Chronocort 20mg (fed)
34357|NCT02408068|P5|Participant Flow|Sequence 5|Hydrocortisone 20mg (fasted), Chronocort 20mg (fed), Chronocort 20mg (fasted)
34358|NCT02408068|P4|Participant Flow|Sequence 4|Chronocort 20mg (fasted), Hydrocortisone 20mg (fasted), Chronocort 20mg (fed)
34359|NCT02408068|P3|Participant Flow|Sequence 3|Chronocort 20mg (fasted), Chronocort 20mg (fed), Hydrocortisone 20mg (fasted)
34360|NCT02408068|P2|Participant Flow|Sequence 2|Chronocort 20mg (fed), Hydrocortisone 20mg (fasted), Chronocort 20mg (fasted)
34361|NCT02408068|P1|Participant Flow|Sequence 1|Chronocort 20mg (fed), Chronocort 20mg (fasted), Hydrocortisone 20mg (fasted)
34362|NCT02408068|O3|Outcome|Chronocort Fed|Volunteers will be admitted, take dexamethasone to suppress endogenous cortisone at 22.00hrs and subsequently fast overnight. On the morning of Day 1, volunteers will eat a high fat breakfast and take 20mg of randomised treatment with 200 millilitres of water. Water will be allowed 1hr after the study drug is administered. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)
34363|NCT02408068|O2|Outcome|Immediate-Release Hydrocortisone|Volunteers will be admitted, take dexamethasone to suppress endogenous cortisone at 22.00hrs, fast overnight, and take 20mg of randomised treatment with 200 millilitres of water on the morning of Day 1. Water will be allowed 1hr after the study drug, but no food for at least 4hrs post dose. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)
34364|NCT02408068|O1|Outcome|Chronocort Fasted|Volunteers will be admitted, take dexamethasone to suppress endogenous cortisone at 22.00hrs, fast overnight, and take 20mg of randomised treatment with 200 millilitres of water on the morning of Day 1. Water will be allowed 1hr after the study drug, but no food for at least 4hrs post dose. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)
34365|NCT02408068|O3|Outcome|Chronocort Fed|Volunteers will be admitted, take dexamethasone to suppress endogenous cortisone at 22.00hrs and subsequently fast overnight. On the morning of Day 1, volunteers will eat a high fat breakfast and take 20mg of randomised treatment with 200 millilitres of water. Water will be allowed 1hr after the study drug is administered. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)
34366|NCT02408068|O2|Outcome|Immediate-Release Hydrocortisone|Volunteers will be admitted, take dexamethasone to suppress endogenous cortisone at 22.00hrs, fast overnight, and take 20mg of randomised treatment with 200 millilitres of water on the morning of Day 1. Water will be allowed 1hr after the study drug, but no food for at least 4hrs post dose. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)
34367|NCT02408068|O1|Outcome|Chronocort Fasted|Volunteers will be admitted, take dexamethasone to suppress endogenous cortisone at 22.00hrs, fast overnight, and take 20mg of randomised treatment with 200 millilitres of water on the morning of Day 1. Water will be allowed 1hr after the study drug, but no food for at least 4hrs post dose. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)
34368|NCT02408068|O3|Outcome|Chronocort Fed|Volunteers will be admitted, take dexamethasone to suppress endogenous cortisone at 22.00hrs and subsequently fast overnight. On the morning of Day 1, volunteers will eat a high fat breakfast and take 20mg of randomised treatment with 200 millilitres of water. Water will be allowed 1hr after the study drug is administered. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)
34369|NCT02408068|O2|Outcome|Immediate-Release Hydrocortisone|Volunteers will be admitted, take dexamethasone to suppress endogenous cortisone at 22.00hrs, fast overnight, and take 20mg of randomised treatment with 200 millilitres of water on the morning of Day 1. Water will be allowed 1hr after the study drug, but no food for at least 4hrs post dose. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)
34370|NCT02408068|O1|Outcome|Chronocort Fasted|Volunteers will be admitted, take dexamethasone to suppress endogenous cortisone at 22.00hrs, fast overnight, and take 20mg of randomised treatment with 200 millilitres of water on the morning of Day 1. Water will be allowed 1hr after the study drug, but no food for at least 4hrs post dose. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)
34371|NCT02408068|O3|Outcome|Immediate-Release Hydrocortisone|Volunteers will be admitted, take dexamethasone to suppress endogenous cortisone at 22.00hrs, fast overnight, and take 20mg of randomised treatment with 200 millilitres of water on the morning of Day 1. Water will be allowed 1hr after the study drug, but no food for at least 4hrs post dose. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)
34372|NCT02408068|O2|Outcome|Chronocort Fasted|Volunteers will be admitted, take dexamethasone to suppress endogenous cortisone at 22.00hrs, fast overnight, and take 20mg of randomised treatment with 200 millilitres of water on the morning of Day 1. Water will be allowed 1hr after the study drug, but no food for at least 4hrs post dose. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)
34456|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
34457|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
34373|NCT02408068|O1|Outcome|Chronocort Fed|Volunteers will be admitted, take dexamethasone to suppress endogenous cortisone at 22.00hrs and subsequently fast overnight. On the morning of Day 1, volunteers will eat a high fat breakfast and take 20mg of randomised treatment with 200 millilitres of water. Water will be allowed 1hr after the study drug is administered. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)
34374|NCT02408068|O3|Outcome|Immediate-Release Hydrocortisone|Volunteers will be admitted, take dexamethasone to suppress endogenous cortisone at 22.00hrs, fast overnight, and take 20mg of randomised treatment with 200 millilitres of water on the morning of Day 1. Water will be allowed 1hr after the study drug, but no food for at least 4hrs post dose. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)
34375|NCT02408068|O2|Outcome|Chronocort Fasted|Volunteers will be admitted, take dexamethasone to suppress endogenous cortisone at 22.00hrs, fast overnight, and take 20mg of randomised treatment with 200 millilitres of water on the morning of Day 1. Water will be allowed 1hr after the study drug, but no food for at least 4hrs post dose. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)
34376|NCT02408068|O1|Outcome|Chronocort Fed|Volunteers will be admitted, take dexamethasone to suppress endogenous cortisone at 22.00hrs and subsequently fast overnight. On the morning of Day 1, volunteers will eat a high fat breakfast and take 20mg of randomised treatment with 200 millilitres of water. Water will be allowed 1hr after the study drug is administered. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)
34377|NCT02408068|O3|Outcome|Immediate-Release Hydrocortisone|Volunteers will be admitted, take dexamethasone to suppress endogenous cortisone at 22.00hrs, fast overnight, and take 20mg of randomised treatment with 200 millilitres of water on the morning of Day 1. Water will be allowed 1hr after the study drug, but no food for at least 4hrs post dose. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)
34378|NCT02408068|O2|Outcome|Chronocort Fasted|Volunteers will be admitted, take dexamethasone to suppress endogenous cortisone at 22.00hrs, fast overnight, and take 20mg of randomised treatment with 200 millilitres of water on the morning of Day 1. Water will be allowed 1hr after the study drug, but no food for at least 4hrs post dose. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)
34379|NCT02408068|O1|Outcome|Chronocort Fed|Volunteers will be admitted, take dexamethasone to suppress endogenous cortisone at 22.00hrs and subsequently fast overnight. On the morning of Day 1, volunteers will eat a high fat breakfast and take 20mg of randomised treatment with 200 millilitres of water. Water will be allowed 1hr after the study drug is administered. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)
34380|NCT02408068|E3|Reported Event|Immediate Release Hydrocortisone: Fasted|"Volunteers will be admitted, take dexamethasone at 22.00hrs, fast overnight, and take 20mg immediate release hydrocortisone with 200 millilitres of water on the morning of Day 1. Water will be allowed 1hr after the study drug, but no food for at least 4hrs post dose. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)~Dexamethasone: Dexamethasone used to suppress endogenous cortisol secretion~Immediate release hydrocortisone: fasted: single dose of 20mg immediate release hydrocortisone in the absence of food"
34381|NCT02408068|E2|Reported Event|Chronocort: Fasted|"Volunteers will be admitted, take dexamethasone at 22.00hrs, fast overnight, and take 20mg modified release hydrocortisone with 200millilitres of water on the morning of Day 1. Water will be allowed 1hr after the dose, but no food for at least 4hrs post dose. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)~Dexamethasone: Dexamethasone used to suppress endogenous cortisol secretion~Chronocort: fasted: single dose of 20mg modified release hydrocortisone in the absence of food"
34382|NCT02408068|E1|Reported Event|Chronocort : Fed|"Volunteers will be admitted, take dexamethasone at 22.00hrs, fast overnight, and receive a high fat, high calorie breakfast on the morning of Day 1. Thirty minutes after the start of the breakfast they will receive 20mg of modified release hydrocortisone with 200 millilitres of water, and no further food for 4 hours, water will be allowed from 1 hour after the food. One baseline pharmacokinetics (PK) sample will be taken starting prior to the dose and then over 24 hours (29 samples).~Dexamethasone: Dexamethasone used to suppress endogenous cortisol secretion~Chronocort: fed: single dose of 20mg modified release hydrocortisone in the presence of food"
34383|NCT02407704|B5|Baseline|Total|Total of all reporting groups
34384|NCT02407704|B4|Baseline|Venlafaxine XR Only (20-39 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).~Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form."
34385|NCT02407704|B3|Baseline|Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
34418|NCT02407704|O2|Outcome|Venlafaxine XR Only (60-79 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form."
34386|NCT02407704|B2|Baseline|Venlafaxine XR Only (60-79 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).~Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form."
34387|NCT02407704|B1|Baseline|Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
34388|NCT02407704|P4|Participant Flow|Venlafaxine XR Only (20-39 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).~Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form."
34389|NCT02407704|P3|Participant Flow|Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
34390|NCT02407704|P2|Participant Flow|Venlafaxine XR Only (60-79 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).~Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form."
34391|NCT02407704|P1|Participant Flow|Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
34392|NCT02407704|O4|Outcome|Venlafaxine XR Only (20-39 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
34393|NCT02407704|O3|Outcome|Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
34394|NCT02407704|O2|Outcome|Venlafaxine XR Only (60-79 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
34395|NCT02407704|O1|Outcome|Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
34407|NCT02407704|O1|Outcome|Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
34396|NCT02407704|O4|Outcome|Venlafaxine XR Only (20-39 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).~Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form."
34397|NCT02407704|O3|Outcome|Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
34398|NCT02407704|O2|Outcome|Venlafaxine XR Only (60-79 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).~Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form."
34399|NCT02407704|O1|Outcome|Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
34400|NCT02407704|O4|Outcome|Venlafaxine XR Only (20-39 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).~Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form."
34401|NCT02407704|O3|Outcome|Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
34402|NCT02407704|O2|Outcome|Venlafaxine XR Only (60-79 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).~Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form."
34403|NCT02407704|O1|Outcome|Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
34404|NCT02407704|O4|Outcome|Venlafaxine XR Only (20-39 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
34405|NCT02407704|O3|Outcome|Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
34406|NCT02407704|O2|Outcome|Venlafaxine XR Only (60-79 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
34408|NCT02407704|O4|Outcome|Venlafaxine XR Only (20-39 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).~Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form."
34409|NCT02407704|O3|Outcome|Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
34410|NCT02407704|O2|Outcome|Venlafaxine XR Only (60-79 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).~Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form."
34411|NCT02407704|O1|Outcome|Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
34412|NCT02407704|O4|Outcome|Venlafaxine XR Only (20-39 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).~Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form."
34413|NCT02407704|O3|Outcome|Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
34414|NCT02407704|O2|Outcome|Venlafaxine XR Only (60-79 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).~Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form."
34415|NCT02407704|O1|Outcome|Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
34416|NCT02407704|O4|Outcome|Venlafaxine XR Only (20-39 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form."
34417|NCT02407704|O3|Outcome|Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
34451|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
34452|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
34419|NCT02407704|O1|Outcome|Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
34420|NCT02407704|E4|Reported Event|Venlafaxine XR Only (20-39 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).~Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form."
34421|NCT02407704|E3|Reported Event|Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
34422|NCT02407704|E2|Reported Event|Venlafaxine XR Only (60-79 Years of Age)|"Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).~Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form."
34423|NCT02407704|E1|Reported Event|Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)|"Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.~Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.~Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours)."
34424|NCT02406937|B4|Baseline|Total|Total of all reporting groups
34425|NCT02406937|B3|Baseline|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
34426|NCT02406937|B2|Baseline|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
34427|NCT02406937|B1|Baseline|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
34428|NCT02406937|P3|Participant Flow|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
34429|NCT02406937|P2|Participant Flow|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
34430|NCT02406937|P1|Participant Flow|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
34431|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Breast Feeding: Oral intake of breast milk"
34432|NCT02406937|O2|Outcome|Feihe Stage 1 Formula|"Oral intake of Feihe stage 1 formula~Oral intake of Feihe Stage 1 Formula: Oral intake of Feihe Stage 1 Formula"
34433|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake of Feihe New Formula: Oral intake of Feihe New Formula"
34434|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
34435|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
34436|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
34437|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
34438|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
34439|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
34440|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
34441|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
34442|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
34443|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
34444|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
34445|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
34446|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
34447|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
34448|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
34449|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
34450|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
34460|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
34461|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
34462|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
34463|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
34464|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
34465|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
34466|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
34467|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
34468|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
34469|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
34470|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
34471|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
34472|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
34473|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
34474|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
34475|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
34476|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
34477|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
34478|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
34479|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
34480|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
34481|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
34482|NCT02406937|E3|Reported Event|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
34483|NCT02406937|E2|Reported Event|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
34484|NCT02406937|E1|Reported Event|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
34485|NCT02406586|B4|Baseline|Total|Total of all reporting groups
34486|NCT02406586|B3|Baseline|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
34487|NCT02406586|B2|Baseline|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34488|NCT02406586|B1|Baseline|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34489|NCT02406586|P3|Participant Flow|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
34490|NCT02406586|P2|Participant Flow|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34491|NCT02406586|P1|Participant Flow|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34492|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
34493|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34494|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34495|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
34496|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34497|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34498|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
34499|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34500|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34501|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
34502|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34503|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34504|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
34505|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34506|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34507|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
34508|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34509|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34510|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
34511|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34549|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34512|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34513|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
34514|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34515|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34516|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
34517|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34518|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34519|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
34520|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34521|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34522|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
34523|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34524|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34525|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
34526|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34527|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34528|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
34550|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34529|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34530|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34531|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
34532|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34533|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34534|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
34535|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34536|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34537|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
34538|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34539|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34540|NCT02406586|E3|Reported Event|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
34541|NCT02406586|E2|Reported Event|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34542|NCT02406586|E1|Reported Event|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
34543|NCT02406495|B1|Baseline|Overall Participants|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34544|NCT02406495|P1|Participant Flow|Overall Participants|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34545|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34546|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34547|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34548|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34666|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34551|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34552|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34553|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34554|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34555|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34556|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34557|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34558|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34559|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34560|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34561|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34562|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34563|NCT02406495|O4|Outcome|Ocufilcon D OS|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34564|NCT02406495|O3|Outcome|Ocufilcon D OD|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34565|NCT02406495|O2|Outcome|Filcon IV 1 OS|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34566|NCT02406495|O1|Outcome|Filcon IV 1 OD|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34567|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34568|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34569|NCT02406495|O4|Outcome|Ocufilcon D OS|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34570|NCT02406495|O3|Outcome|Ocufilcon D OD|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34571|NCT02406495|O2|Outcome|Filcon IV 1 OS|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34572|NCT02406495|O1|Outcome|Filcon IV 1 OD|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34573|NCT02406495|O4|Outcome|Ocufilcon D OS (Oculus Sinister)|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34574|NCT02406495|O3|Outcome|Ocufilcon D OD (Oculus Dexter)|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34575|NCT02406495|O2|Outcome|Filcon IV 1 OS (Oculus Sinister)|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34576|NCT02406495|O1|Outcome|Filcon IV 1 OD (Oculus Dexter)|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34577|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34578|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34579|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34580|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34581|NCT02406495|E1|Reported Event|Overall Participants|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
34582|NCT02406443|B3|Baseline|Total|Total of all reporting groups
34583|NCT02406443|B2|Baseline|Placebo Arm|"placebo (no medicinal ingredients) oral tablet (100 mg); administered once daily for 28 days~Placebo: Oral tablet (no medicinal ingredients) administered once daily for 28 days"
34584|NCT02406443|B1|Baseline|Experimental Arm|"sitagliptin (DPP-4 inhibitor) oral tablet (100 mg); Januvia; administered once daily for 28 days~Sitaglitpin: Oral DPP-4 inhibitor, 100 mg tablet administered once daily for 28 days"
34585|NCT02406443|P2|Participant Flow|Placebo Arm|"placebo (no medicinal ingredients) oral tablet (100 mg); administered once daily for 28 days~Placebo: Oral tablet (no medicinal ingredients) administered once daily for 28 days"
34586|NCT02406443|P1|Participant Flow|Experimental Arm|"sitagliptin (DPP-4 inhibitor) oral tablet (100 mg); Januvia; administered once daily for 28 days~Sitaglitpin: Oral DPP-4 inhibitor, 100 mg tablet administered once daily for 28 days"
39978|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
34587|NCT02406443|O2|Outcome|Placebo Arm|"placebo (no medicinal ingredients) oral tablet (100 mg); administered once daily for 28 days~Placebo: Oral tablet (no medicinal ingredients) administered once daily for 28 days"
34588|NCT02406443|O1|Outcome|Experimental Arm|"sitagliptin (DPP-4 inhibitor) oral tablet (100 mg); Januvia; administered once daily for 28 days~Sitaglitpin: Oral DPP-4 inhibitor, 100 mg tablet administered once daily for 28 days"
34589|NCT02406443|O2|Outcome|Placebo Arm|"placebo (no medicinal ingredients) oral tablet (100 mg); administered once daily for 28 days~Placebo: Oral tablet (no medicinal ingredients) administered once daily for 28 days"
34590|NCT02406443|O1|Outcome|Experimental Arm|"sitagliptin (DPP-4 inhibitor) oral tablet (100 mg); Januvia; administered once daily for 28 days~Sitaglitpin: Oral DPP-4 inhibitor, 100 mg tablet administered once daily for 28 days"
34591|NCT02406443|O2|Outcome|Placebo Arm|"placebo (no medicinal ingredients) oral tablet (100 mg); administered once daily for 28 days~Placebo: Oral tablet (no medicinal ingredients) administered once daily for 28 days"
34592|NCT02406443|O1|Outcome|Experimental Arm|"sitagliptin (DPP-4 inhibitor) oral tablet (100 mg); Januvia; administered once daily for 28 days~Sitaglitpin: Oral DPP-4 inhibitor, 100 mg tablet administered once daily for 28 days"
34593|NCT02406443|O2|Outcome|Placebo Arm|"placebo (no medicinal ingredients) oral tablet (100 mg); administered once daily for 28 days~Placebo: Oral tablet (no medicinal ingredients) administered once daily for 28 days"
34594|NCT02406443|O1|Outcome|Experimental Arm|"sitagliptin (DPP-4 inhibitor) oral tablet (100 mg); Januvia; administered once daily for 28 days~Sitaglitpin: Oral DPP-4 inhibitor, 100 mg tablet administered once daily for 28 days"
34595|NCT02406443|O2|Outcome|Placebo Arm|"placebo (no medicinal ingredients) oral tablet (100 mg); administered once daily for 28 days~Placebo: Oral tablet (no medicinal ingredients) administered once daily for 28 days"
34596|NCT02406443|O1|Outcome|Experimental Arm|"sitagliptin (DPP-4 inhibitor) oral tablet (100 mg); Januvia; administered once daily for 28 days~Sitaglitpin: Oral DPP-4 inhibitor, 100 mg tablet administered once daily for 28 days"
34597|NCT02406443|O2|Outcome|Placebo Arm|"placebo (no medicinal ingredients) oral tablet (100 mg); administered once daily for 28 days~Placebo: Oral tablet (no medicinal ingredients) administered once daily for 28 days"
34598|NCT02406443|O1|Outcome|Experimental Arm|"sitagliptin (DPP-4 inhibitor) oral tablet (100 mg); Januvia; administered once daily for 28 days~Sitaglitpin: Oral DPP-4 inhibitor, 100 mg tablet administered once daily for 28 days"
34599|NCT02406443|O2|Outcome|Placebo Arm|"placebo (no medicinal ingredients) oral tablet (100 mg); administered once daily for 28 days~Placebo: Oral tablet (no medicinal ingredients) administered once daily for 28 days"
34600|NCT02406443|O1|Outcome|Experimental Arm|"sitagliptin (DPP-4 inhibitor) oral tablet (100 mg); Januvia; administered once daily for 28 days~Sitaglitpin: Oral DPP-4 inhibitor, 100 mg tablet administered once daily for 28 days"
34601|NCT02406443|E2|Reported Event|Placebo Arm|"placebo (no medicinal ingredients) oral tablet (100 mg); administered once daily for 28 days~Placebo: Oral tablet (no medicinal ingredients) administered once daily for 28 days"
34602|NCT02406443|E1|Reported Event|Experimental Arm|"sitagliptin (DPP-4 inhibitor) oral tablet (100 mg); Januvia; administered once daily for 28 days~Sitaglitpin: Oral DPP-4 inhibitor, 100 mg tablet administered once daily for 28 days"
34603|NCT02405429|B1|Baseline|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
34604|NCT02405429|P1|Participant Flow|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
34605|NCT02405429|O1|Outcome|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
34606|NCT02405429|O1|Outcome|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
34607|NCT02405429|O1|Outcome|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
34608|NCT02405429|O1|Outcome|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
34609|NCT02405429|O1|Outcome|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
34610|NCT02405429|E1|Reported Event|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
34611|NCT02405390|B3|Baseline|Total|Total of all reporting groups
34612|NCT02405390|B2|Baseline|Direct Laryngoscopy|"Some patients will be intubated with a direct (conventional) laryngoscope~Direct Laryngoscopy: Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords~Storz C-Mac® laryngoscope"
34613|NCT02405390|B1|Baseline|Video Laryngoscopy|"Some patients will be intubated with a video laryngoscope~Video Laryngoscopy: Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system~Storz C-Mac® laryngoscope"
34614|NCT02405390|P2|Participant Flow|Direct Laryngoscopy|"Some patients will be intubated with a direct (conventional) laryngoscope~Direct Laryngoscopy: Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords~Storz C-Mac® laryngoscope"
34615|NCT02405390|P1|Participant Flow|Video Laryngoscopy|"Some patients will be intubated with a video laryngoscope~Video Laryngoscopy: Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system~Storz C-Mac® laryngoscope"
34616|NCT02405390|O2|Outcome|Direct Laryngoscopy|Some patients will be intubated with a direct (conventional) laryngoscope. Head motion (extension, Flexion, Roation Right and Rotation Left) will be measured by using Polhemus Patriot™ electromagnetic tracking system
34617|NCT02405390|O1|Outcome|Video Laryngoscopy|Some patients will be intubated with a video laryngoscope. Head motion (extension, Flexion, Roation Right and Rotation Left) will be measured by using Polhemus Patriot™ electromagnetic tracking system
34618|NCT02405390|O2|Outcome|Direct Laryngoscopy|Some patients will be intubated with a direct (conventional) laryngoscope. Head motion (extension, Flexion, Roation Right and Rotation Left) will be measured by using Polhemus Patriot™ electromagnetic tracking system
34619|NCT02405390|O1|Outcome|Video Laryngoscopy|Some patients will be intubated with a video laryngoscope. Head motion (extension, Flexion, Roation Right and Rotation Left) will be measured by using Polhemus Patriot™ electromagnetic tracking system
34620|NCT02405390|E2|Reported Event|Direct Laryngoscopy|"Some patients will be intubated with a direct (conventional) laryngoscope~Direct Laryngoscopy: Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords~Storz C-Mac® laryngoscope"
34621|NCT02405390|E1|Reported Event|Video Laryngoscopy|"Some patients will be intubated with a video laryngoscope~Video Laryngoscopy: Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system~Storz C-Mac® laryngoscope"
34622|NCT02404649|B3|Baseline|Total|Total of all reporting groups
34623|NCT02404649|B2|Baseline|Sinus Elevation Only|"Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Floor Elevation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus elevation only environment.~sinus elevation only"
34624|NCT02404649|B1|Baseline|Bone Augmention|"Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Bone Augmentation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus bone augmentation environment.~sinus bone augmentation"
34625|NCT02404649|P2|Participant Flow|Sinus Elevation Only|"Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Floor Elevation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus elevation only environment.~sinus elevation only"
34626|NCT02404649|P1|Participant Flow|Bone Augmention|"Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Bone Augmentation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus bone augmentation environment.~sinus bone augmentation"
34627|NCT02404649|O2|Outcome|Sinus Elevation Only|"Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Floor Elevation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus elevation only environment.~sinus elevation only"
34628|NCT02404649|O1|Outcome|Bone Augmention|"Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Bone Augmentation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus bone augmentation environment.~sinus bone augmentation"
34629|NCT02404649|E2|Reported Event|Sinus Elevation Only|"Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Floor Elevation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus elevation only environment.~sinus elevation only"
34667|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34668|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34669|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34670|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
35854|NCT02393950|O3|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10mg 1 x 5 mg ODM-106 Capsule B
34630|NCT02404649|E1|Reported Event|Bone Augmention|"Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Bone Augmentation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus bone augmentation environment.~sinus bone augmentation"
34631|NCT02404545|B3|Baseline|Total|Total of all reporting groups
34632|NCT02404545|B2|Baseline|Group 2 - Ileal Conduit With Mesh|"Ethicon Physiomesh will be placed at the time of radical cystectomy and ileal conduit.~Ethicon Physiomesh: Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit."
34633|NCT02404545|B1|Baseline|Group 1 - Ideal Conduit No Mesh|No mesh will be placed at the time of radical cystectomy and ileal conduit.
34634|NCT02404545|P2|Participant Flow|Group 2 - Ileal Conduit With Mesh|"Ethicon Physiomesh will be placed at the time of radical cystectomy and ileal conduit.~Ethicon Physiomesh: Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit."
34635|NCT02404545|P1|Participant Flow|Group 1 - Ideal Conduit No Mesh|No mesh will be placed at the time of radical cystectomy and ileal conduit.
34636|NCT02404545|O1|Outcome|Group 2 - Ileal Conduit With Mesh|"Ethicon Physiomesh will be placed at the time of radical cystectomy and ileal conduit.~Ethicon Physiomesh: Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit."
34637|NCT02404545|O2|Outcome|Group 2 - Ileal Conduit With Mesh|"Ethicon Physiomesh will be placed at the time of radical cystectomy and ileal conduit.~Ethicon Physiomesh: Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit."
34638|NCT02404545|O1|Outcome|Group 1 - Ideal Conduit No Mesh|No mesh will be placed at the time of radical cystectomy and ileal conduit.
34639|NCT02404545|E2|Reported Event|Group 2 - Ileal Conduit With Mesh|"Ethicon Physiomesh will be placed at the time of radical cystectomy and ileal conduit.~Ethicon Physiomesh: Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit."
34640|NCT02404545|E1|Reported Event|Group 1 - Ideal Conduit No Mesh|No mesh will be placed at the time of radical cystectomy and ileal conduit.
34641|NCT02404493|B3|Baseline|Total|Total of all reporting groups
34642|NCT02404493|B2|Baseline|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34643|NCT02404493|B1|Baseline|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34644|NCT02404493|P2|Participant Flow|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34645|NCT02404493|P1|Participant Flow|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34646|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34647|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34648|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34649|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34650|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34651|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34652|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34653|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34654|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34655|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34656|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34657|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34658|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34659|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34660|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34661|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34662|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34663|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34664|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34665|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
35855|NCT02393950|O2|Outcome|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B
34671|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34672|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34673|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34674|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34675|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34676|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34677|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34678|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34679|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34680|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34681|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34682|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34683|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34684|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34685|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34686|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34687|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34688|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34689|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34690|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34691|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34692|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34693|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34694|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34695|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34696|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34697|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34698|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34699|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34700|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34701|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34702|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34703|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34704|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34705|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34706|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34707|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34708|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34709|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34710|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34711|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
35856|NCT02393950|O1|Outcome|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B
34712|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34713|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34714|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34715|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34716|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34717|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34718|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34719|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34720|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34721|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34722|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34723|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34724|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34725|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34726|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34727|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34728|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34729|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34730|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34731|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34732|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34733|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34734|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34735|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34736|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34737|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34738|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34739|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34740|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34741|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34742|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34743|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34744|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34745|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34746|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34747|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34748|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34749|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34750|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34751|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34752|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
35857|NCT02393950|O9|Outcome|Placebo|2 placebo subjects per Arm with matched number of placebo capsules.
34753|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34754|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34755|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34756|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34757|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34758|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34759|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34760|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34761|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34762|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34763|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34764|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34765|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34766|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34767|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34768|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34769|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34770|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34771|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34772|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34773|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34774|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34775|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34776|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34777|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34778|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34779|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34780|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34781|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34782|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34783|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34784|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34785|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34786|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34787|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34788|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34789|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34790|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34791|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34792|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34793|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
35858|NCT02393950|O8|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10 mg ODM-106 Capsule A.
34794|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34795|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34796|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34797|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34798|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34799|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34800|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34801|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34802|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34803|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34804|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34805|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34806|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34807|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34808|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34809|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34810|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34811|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34812|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34813|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34814|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34815|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34816|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34817|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34818|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34819|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34820|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34821|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34822|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34823|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34824|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34825|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34826|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34827|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34828|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34829|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34830|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34831|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34832|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34833|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34834|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
35859|NCT02393950|O7|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10 mg ODM-106 Capsule B.
34835|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34836|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34837|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34838|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34839|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34840|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34841|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34842|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34843|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34844|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34845|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34846|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34847|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34848|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34849|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34850|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34851|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34852|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34853|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34854|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34855|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34856|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34857|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34858|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34859|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34860|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34861|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34862|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34863|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34864|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34865|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34866|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34867|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34868|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34869|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34870|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34871|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34872|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34873|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34874|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34875|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
39979|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
34876|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34877|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34878|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34879|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34880|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34881|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34882|NCT02404493|E2|Reported Event|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
34883|NCT02404493|E1|Reported Event|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
34884|NCT02404389|B6|Baseline|Total|Total of all reporting groups
34885|NCT02404389|B5|Baseline|Aldara|Aldara cream 3 applications per week
34886|NCT02404389|B4|Baseline|Vehicle to LCC|Vehicle to liquid crystal cream (LCC) Twice daily applications
34887|NCT02404389|B3|Baseline|Vehicle to NMC|Vehicle to nanomedicinal cream (NMC) Twice daily applications
34888|NCT02404389|B2|Baseline|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
34889|NCT02404389|B1|Baseline|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
34890|NCT02404389|P5|Participant Flow|Aldara|Aldara cream 3 applications per week
34891|NCT02404389|P4|Participant Flow|Vehicle to LCC|Vehicle to liquid crystal cream (LCC) Twice daily applications
34892|NCT02404389|P3|Participant Flow|Vehicle to NMC|Vehicle to nanomedicinal cream (NMC) Twice daily applications
34893|NCT02404389|P2|Participant Flow|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
34894|NCT02404389|P1|Participant Flow|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
34895|NCT02404389|O4|Outcome|Aldara|Aldara cream 3 applications per week
34896|NCT02404389|O3|Outcome|Combined Vehicle|Vehicle to nanomedicinal cream (NMC) and Vehicle to liquid crystal cream (LCC) Twice daily applications
34897|NCT02404389|O2|Outcome|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
34898|NCT02404389|O1|Outcome|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
34899|NCT02404389|O4|Outcome|Aldara|Aldara cream 3 applications per week
34900|NCT02404389|O3|Outcome|Combined Vehicle|Vehicle to nanomedicinal cream (NMC) and Vehicle to liquid crystal cream (LCC) Twice daily applications
34901|NCT02404389|O2|Outcome|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
34902|NCT02404389|O1|Outcome|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
34903|NCT02404389|O4|Outcome|Aldara|Aldara cream 3 applications per week
34904|NCT02404389|O3|Outcome|Combined Vehicle|Vehicle to nanomedicinal cream (NMC) and Vehicle to liquid crystal cream (LCC) Twice daily applications
34905|NCT02404389|O2|Outcome|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
34906|NCT02404389|O1|Outcome|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
34907|NCT02404389|O4|Outcome|Aldara|Aldara cream 3 applications per week
34908|NCT02404389|O3|Outcome|Combined Vehicle|Vehicle to nanomedicinal cream (NMC) and Vehicle to liquid crystal cream (LCC) Twice daily applications
34909|NCT02404389|O2|Outcome|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
34910|NCT02404389|O1|Outcome|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
34911|NCT02404389|O4|Outcome|Aldara|Aldara cream 3 applications per week
34912|NCT02404389|O3|Outcome|Combined Vehicle|Vehicle to nanomedicinal cream (NMC) and Vehicle to liquid crystal cream (LCC) Twice daily applications
34913|NCT02404389|O2|Outcome|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
34914|NCT02404389|O1|Outcome|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
34915|NCT02404389|O4|Outcome|Aldara|Aldara cream 3 applications per week
34916|NCT02404389|O3|Outcome|Combined Vehicle|Vehicle to nanomedicinal cream (NMC) and Vehicle to liquid crystal cream (LCC) Twice daily applications
34917|NCT02404389|O2|Outcome|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
34918|NCT02404389|O1|Outcome|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
34919|NCT02404389|O5|Outcome|Aldara|Aldara cream 3 applications per week
34920|NCT02404389|O4|Outcome|Vehicle to LCC|Vehicle to liquid crystal cream (LCC) Twice daily applications
34921|NCT02404389|O3|Outcome|Vehicle to NMC|Vehicle to nanomedicinal cream (NMC) Twice daily applications
34922|NCT02404389|O2|Outcome|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
34923|NCT02404389|O1|Outcome|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
34924|NCT02404389|E5|Reported Event|Aldara|Aldara cream 3 applications per week
34925|NCT02404389|E4|Reported Event|Vehicle to LCC|Vehicle to liquid crystal cream (LCC) Twice daily applications
34926|NCT02404389|E3|Reported Event|Vehicle to NMC|Vehicle to nanomedicinal cream (NMC) Twice daily applications
34927|NCT02404389|E2|Reported Event|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
34928|NCT02404389|E1|Reported Event|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
34929|NCT02404103|B3|Baseline|Total|Total of all reporting groups
34930|NCT02404103|B2|Baseline|Flunisolide 320 mcg Per Day|"Patients will receive inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period~Flunisolide HFA"
39980|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
34931|NCT02404103|B1|Baseline|Flunisolide 160 mcg Per Day|"Patients will receive inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period~Flunisolide HFA"
34932|NCT02404103|P2|Participant Flow|Flunisolide 320 mcg Per Day|"Patients will receive inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period~Flunisolide HFA"
34933|NCT02404103|P1|Participant Flow|Flunisolide 160 mcg Per Day|"Patients will receive inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period~Flunisolide HFA"
34934|NCT02404103|O4|Outcome|Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks|"After 6 week valeus for patients who received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period~Flunisolide HFA"
34935|NCT02404103|O3|Outcome|Flunisolide 160 mcg Per Day Posttreatment - 6 Wks|After 6 weeks treatment value for Patients who received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period
34936|NCT02404103|O2|Outcome|Flunisolide 320 mcg Per Day Pretreatment - Baseline|"Baseline for patients who received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period~Flunisolide HFA"
34937|NCT02404103|O1|Outcome|Flunisolide 160 mcg Per Day Pretreatment - Baseline|"Baseline value for Patients who received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period~Flunisolide HFA"
34938|NCT02404103|O4|Outcome|Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks|Six week followup in patients who received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period
34939|NCT02404103|O3|Outcome|Flunisolide 160 mcg Per Day Posttreatment - 6 Wks|Six week followup in Patients who received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period
34940|NCT02404103|O2|Outcome|Flunisolide 320 mcg Per Day Pretreatment - Baseline|Baseline in patients who received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period
34941|NCT02404103|O1|Outcome|Flunisolide 160 mcg Per Day Pretreatment - Baseline|Baseline in Patients who received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period
34942|NCT02404103|O4|Outcome|Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks|After 6 weeks treatment value for Patients who received inhaled Flunisolide HFA 160 mg twiece a day.
34943|NCT02404103|O3|Outcome|Flunisolide 160 mcg Per Day Posttreatment - 6 Wks|After 6 weeks treatment value forPatients who received inhaled Flunisolide HFA 80 mg twice per day.
34944|NCT02404103|O2|Outcome|Flunisolide 320 mcg Per Day Pretreatment - Baseline|"Before Patients received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period~Flunisolide HFA"
34945|NCT02404103|O1|Outcome|Flunisolide 160 mcg Per Day Pretreatment - Baseline|"Before Patients received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period~Flunisolide HFA"
34946|NCT02404103|O4|Outcome|Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks|"After 6 week valeus for patients who received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period~Flunisolide HFA"
34947|NCT02404103|O3|Outcome|Flunisolide 160 mcg Per Day Posttreatment - 6 Wks|After 6 weeks treatment value for Patients who received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period
34948|NCT02404103|O2|Outcome|Flunisolide 320 mcg Per Day Pretreatment - Baseline|"Baseline for patients who received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period~Flunisolide HFA"
34949|NCT02404103|O1|Outcome|Flunisolide 160 mcg Per Day Pretreatment - Baseline|"Baseline value for Patients who received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period~Flunisolide HFA"
34950|NCT02404103|E2|Reported Event|Flunisolide 320 mcg Per Day|"Patients will receive inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period~Flunisolide HFA"
34951|NCT02404103|E1|Reported Event|Flunisolide 160 mcg Per Day|"Patients will receive inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period~Flunisolide HFA"
34952|NCT02403830|B1|Baseline|Whole Study Population|Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7 ± 2 days wash-out period, patients crossed-over to the alternate study-treatment arm.
34953|NCT02403830|P2|Participant Flow|Placebo First|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. In this arm patients received placebo at visit 1. After a 7 ± 2 days wash-out period, patients crossed-over to the alternate study-treatment arm (methylnaltrexone).~Placebo: Placebo will be administered as a 0.9% sodium chloride iv injection~Morphine: After methylnaltrexone, patients will receive 5-mg intravenous morphine~Ticagrelor: After morphine administration, patients will receive a 180-mg ticagrelor loading dose"
34954|NCT02403830|P1|Participant Flow|Methylnaltrexone First|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. In this arm patients received methylnaltrexone at visit 1. After a 7 ± 2 days wash-out period, patients crossed-over to the alternate study-treatment arm (placebo).~Methylnaltrexone: Methylnaltrexone will be administered diluted with 5 ml of normal saline as a single iv bolus~Morphine: After methylnaltrexone, patients will receive 5-mg intravenous morphine~Ticagrelor: After morphine administration, patients will receive a 180-mg ticagrelor loading dose"
35020|NCT02403180|P2|Participant Flow|PROCLEAR 1D MF, Then DACP MF|Omafilcon A contact lenses were worn in Period 1, followed by nelfilcon A contact lenses in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.
34955|NCT02403830|O2|Outcome|Placebo|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.~Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
34956|NCT02403830|O1|Outcome|Methylnaltrexone|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.~Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
34957|NCT02403830|O2|Outcome|Placebo|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.~Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
34958|NCT02403830|O1|Outcome|Methylnaltrexone|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.~Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
34959|NCT02403830|O2|Outcome|Placebo|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.~Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
34960|NCT02403830|O1|Outcome|Methylnaltrexone|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.~Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
34961|NCT02403830|E2|Reported Event|Placebo|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.~Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
34962|NCT02403830|E1|Reported Event|Methylnaltrexone|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.~Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
34963|NCT02403674|B3|Baseline|Total|Total of all reporting groups
34964|NCT02403674|B2|Baseline|ATRIPLA™|Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34965|NCT02403674|B1|Baseline|MK-1439A|Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34966|NCT02403674|P2|Participant Flow|ATRIPLA™|Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
39981|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
34967|NCT02403674|P1|Participant Flow|MK-1439A|Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, once daily (q.d.) by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34968|NCT02403674|O1|Outcome|MK-1439A|Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34969|NCT02403674|O2|Outcome|ATRIPLA™|Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34970|NCT02403674|O1|Outcome|MK-1439A|Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34971|NCT02403674|O2|Outcome|ATRIPLA™|Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34972|NCT02403674|O1|Outcome|MK-1439A|Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34973|NCT02403674|O2|Outcome|ATRIPLA™|Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34974|NCT02403674|O1|Outcome|MK-1439A|Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34975|NCT02403674|O2|Outcome|ATRIPLA™|Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34976|NCT02403674|O1|Outcome|MK-1439A|Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34977|NCT02403674|O2|Outcome|ATRIPLA™|Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34978|NCT02403674|O1|Outcome|MK-1439A|Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34979|NCT02403674|O2|Outcome|ATRIPLA™|Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34980|NCT02403674|O1|Outcome|MK-1439A|Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
35294|NCT02400580|B1|Baseline|Intravenous IV Acetaminophen|"The patients in the treatment arm will receive 1000mg of IV acetaminophen.~IV acetaminophen"
34981|NCT02403674|O2|Outcome|ATRIPLA™|Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34982|NCT02403674|O1|Outcome|MK-1439A|Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34983|NCT02403674|O2|Outcome|ATRIPLA™|Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34984|NCT02403674|O1|Outcome|MK-1439A|Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34985|NCT02403674|O2|Outcome|ATRIPLA™|Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34986|NCT02403674|O1|Outcome|MK-1439A|Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34987|NCT02403674|O2|Outcome|ATRIPLA™|Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34988|NCT02403674|O1|Outcome|MK-1439A|Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34989|NCT02403674|O2|Outcome|ATRIPLA™|Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34990|NCT02403674|O1|Outcome|MK-1439A|Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34991|NCT02403674|O2|Outcome|ATRIPLA™|Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34992|NCT02403674|O1|Outcome|MK-1439A|Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34993|NCT02403674|O2|Outcome|ATRIPLA™|Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34994|NCT02403674|O1|Outcome|MK-1439A|Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
35295|NCT02400580|P2|Participant Flow|Normal Saline|"The patients in the placebo arm will receive normal saline.~placebo"
34995|NCT02403674|O2|Outcome|ATRIPLA™|Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34996|NCT02403674|O1|Outcome|MK-1439A|Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34997|NCT02403674|O2|Outcome|ATRIPLA™|Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34998|NCT02403674|O1|Outcome|MK-1439A|Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
34999|NCT02403674|O2|Outcome|ATRIPLA™|Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
35000|NCT02403674|O1|Outcome|MK-1439A|Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
35001|NCT02403674|O2|Outcome|ATRIPLA™|Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
35002|NCT02403674|O1|Outcome|MK-1439A|Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
35003|NCT02403674|E2|Reported Event|ATRIPLA (EFA+EMT+TEN)|Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
35004|NCT02403674|E1|Reported Event|MK-1439A (DOR+LAM+TEN)|Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
35005|NCT02403206|B3|Baseline|Total|Total of all reporting groups
35006|NCT02403206|B2|Baseline|Manual (CCC)|CCC performed during cataract surgery
35007|NCT02403206|B1|Baseline|Laser (LSX)|Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery
35008|NCT02403206|P2|Participant Flow|Manual (CCC)|Continuous curvilinear capsulorhexis (CCC) performed during cataract surgery
35009|NCT02403206|P1|Participant Flow|Laser (LSX)|Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery
35010|NCT02403206|O2|Outcome|Manual (CCC)|CCC performed during cataract surgery
35011|NCT02403206|O1|Outcome|Laser (LSX)|Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery
35012|NCT02403206|O2|Outcome|Manual (CCC)|CCC performed during cataract surgery
35013|NCT02403206|O1|Outcome|Laser (LSX)|Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery
35014|NCT02403206|E3|Reported Event|Manual (CCC)|Subjects who underwent CCC-assisted cataract surgery
35015|NCT02403206|E2|Reported Event|Laser (LSX)|Subjects who underwent femtosecond laser-assisted cataract surgery
35016|NCT02403206|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to initiation of study treatment
35017|NCT02403180|B3|Baseline|Total|Total of all reporting groups
35018|NCT02403180|B2|Baseline|PROCLEAR 1D MF, Then DACP MF|Omafilcon A contact lenses were worn in Period 1, followed by nelfilcon A contact lenses in Period 2.
35019|NCT02403180|B1|Baseline|DACP MF, Then PROCLEAR 1D MF|Nelfilcon A contact lenses were worn in Period 1, followed by omafilcon A contact lenses in Period 2.
35120|NCT02402127|B3|Baseline|MyDay, TruEye, Clariti 1day|Stenfilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3
35021|NCT02403180|P1|Participant Flow|DACP MF, Then PROCLEAR 1D MF|Nelfilcon A contact lenses were worn in Period 1, followed by omafilcon A contact lenses in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.
35022|NCT02403180|O2|Outcome|DACP MF|Nelfilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
35023|NCT02403180|O1|Outcome|Proclear 1 Day MF|Omafilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
35024|NCT02403180|O2|Outcome|DACP MF|Nelfilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
35025|NCT02403180|O1|Outcome|Proclear 1 Day MF|Omafilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
35026|NCT02403180|E2|Reported Event|DACP MF|Nelfilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
35027|NCT02403180|E1|Reported Event|Proclear 1 Day MF|Omafilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
35028|NCT02403154|B5|Baseline|Total|Total of all reporting groups
35029|NCT02403154|B4|Baseline|Observational - External Fixator|"Patient signed consent but did not want to randomize their procedure and either the treating physician selected the external fixator intervention based on their preference for the specific case or the patient chose the external fixator.~External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body."
35030|NCT02403154|B3|Baseline|Observational - Internal Fixator|"Patient signed consent but did not want to randomize their procedure and either the treating physician selected the internal fixator intervention based on their preference for the specific case or the patient chose the internal fixator.~Internal Fixator: Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally."
35031|NCT02403154|B2|Baseline|Randomized to External Fixator|"Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be external fixator.~External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body."
35032|NCT02403154|B1|Baseline|Randomized to Internal Fixator|"Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be internal fixator.~Internal Fixator: Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally."
35033|NCT02403154|P4|Participant Flow|Observational - External Fixator|"Patient signed consent but did not want to randomize their procedure and either the treating physician selected the external fixator intervention based on their preference for the specific case or the patient chose the external fixator.~External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body."
35034|NCT02403154|P3|Participant Flow|Observational - Internal Fixator|"Patient signed consent but did not want to randomize their procedure and either the treating physician selected the internal fixator intervention based on their preference for the specific case or the patient chose the internal fixator.~Internal Fixator: Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally."
35035|NCT02403154|P2|Participant Flow|Randomized to External Fixator|"Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be external fixator.~External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body."
35036|NCT02403154|P1|Participant Flow|Randomized to Internal Fixator|"Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be internal fixator.~Internal Fixator: Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally."
35037|NCT02403154|O4|Outcome|Observational - External Fixator|"Patient signed consent but did not want to randomize their procedure and either the treating physician selected the external fixator intervention based on their preference for the specific case or the patient chose the external fixator.~External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body."
35038|NCT02403154|O3|Outcome|Observational - Internal Fixator|"Patient signed consent but did not want to randomize their procedure and either the treating physician selected the internal fixator intervention based on their preference for the specific case or the patient chose the internal fixator.~Internal Fixator: Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally."
35039|NCT02403154|O2|Outcome|Randomized to External Fixator|"Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be external fixator.~External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body."
35040|NCT02403154|O1|Outcome|Randomized to Internal Fixator|"Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be internal fixator.~Internal Fixator: Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally."
35041|NCT02403154|O4|Outcome|Observational - External Fixator|"Patient signed consent but did not want to randomize their procedure and either the treating physician selected the external fixator intervention based on their preference for the specific case or the patient chose the external fixator.~External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body."
35042|NCT02403154|O3|Outcome|Observational - Internal Fixator|"Patient signed consent but did not want to randomize their procedure and either the treating physician selected the internal fixator intervention based on their preference for the specific case or the patient chose the internal fixator.~Internal Fixator: Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally."
39982|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
35043|NCT02403154|O2|Outcome|Randomized to External Fixator|"Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be external fixator.~External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body."
35044|NCT02403154|O1|Outcome|Randomized to Internal Fixator|"Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be internal fixator.~Internal Fixator: Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally."
35045|NCT02403154|E4|Reported Event|Observational - External Fixator|"Patient signed consent but did not want to randomize their procedure and either the treating physician selected the external fixator intervention based on their preference for the specific case or the patient chose the external fixator.~External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body."
35046|NCT02403154|E3|Reported Event|Observational - Internal Fixator|"Patient signed consent but did not want to randomize their procedure and either the treating physician selected the internal fixator intervention based on their preference for the specific case or the patient chose the internal fixator.~Internal Fixator: Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally."
35047|NCT02403154|E2|Reported Event|Randomized to External Fixator|"Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be external fixator.~External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body."
35048|NCT02403154|E1|Reported Event|Randomized to Internal Fixator|"Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be internal fixator.~Internal Fixator: Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally."
35049|NCT02402933|B1|Baseline|Nasal Glucagon|Glucagon: 3 mg glucagon powder
35050|NCT02402933|P1|Participant Flow|Nasal Glucagon|Four doses of AMG504-1 (3 mg glucagon powder per dose) were dispensed to participants and each participant/caregiver were encouraged to keep one dose with them at all times and the other doses in a convenient location.
35051|NCT02402933|O1|Outcome|Nasal Glucagon|3 mg glucagon powder
35052|NCT02402933|O1|Outcome|Nasal Glucagon|3 mg glucagon powder
35053|NCT02402933|O1|Outcome|Nasal Glucagon|3 mg glucagon powder
35054|NCT02402933|O1|Outcome|Nasal Glucagon|3 mg glucagon powder
35055|NCT02402933|E1|Reported Event|Nasal Glucagon|3 mg glucagon powder
35056|NCT02402764|B1|Baseline|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
35057|NCT02402764|P1|Participant Flow|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
35058|NCT02402764|O1|Outcome|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
35059|NCT02402764|O1|Outcome|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
35060|NCT02402764|O1|Outcome|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
35061|NCT02402764|O1|Outcome|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
35062|NCT02402764|O1|Outcome|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
35063|NCT02402764|E1|Reported Event|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
35064|NCT02402322|B4|Baseline|Total|Total of all reporting groups
35065|NCT02402322|B3|Baseline|Waiting List|Participants in a waiting list.
35066|NCT02402322|B2|Baseline|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
35067|NCT02402322|B1|Baseline|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
35068|NCT02402322|P3|Participant Flow|Waiting List|Participants in a waiting list.
35069|NCT02402322|P2|Participant Flow|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
35070|NCT02402322|P1|Participant Flow|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
35071|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
35072|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
35073|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
35074|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
35075|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
35076|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
35077|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
35078|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
35079|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
35080|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
35081|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
35082|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
35083|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
35084|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
35085|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
35086|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
35087|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
35088|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
35089|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
35090|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
35091|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
35092|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
35093|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
35094|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
35095|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
35096|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
35097|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
35098|NCT02402322|E3|Reported Event|Waiting List|Participants in a waiting list.
35121|NCT02402127|B2|Baseline|TruEye, Clariti 1day, MyDay|Narafilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3
35099|NCT02402322|E2|Reported Event|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
35100|NCT02402322|E1|Reported Event|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
35101|NCT02402296|B3|Baseline|Total|Total of all reporting groups
35102|NCT02402296|B2|Baseline|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.~Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
35103|NCT02402296|B1|Baseline|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.~β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
35104|NCT02402296|P2|Participant Flow|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.~β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
35105|NCT02402296|P1|Participant Flow|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.~Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
35106|NCT02402296|O2|Outcome|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.~β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
35107|NCT02402296|O1|Outcome|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.~Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
35108|NCT02402296|O2|Outcome|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.~β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
35109|NCT02402296|O1|Outcome|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.~Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
35110|NCT02402296|O2|Outcome|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.~β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
35111|NCT02402296|O1|Outcome|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.~Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
35112|NCT02402296|O2|Outcome|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.~β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
35113|NCT02402296|O1|Outcome|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.~Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
35114|NCT02402296|E2|Reported Event|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.~β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
35115|NCT02402296|E1|Reported Event|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.~Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
35116|NCT02402127|B7|Baseline|Total|Total of all reporting groups
35117|NCT02402127|B6|Baseline|Clariti 1day, MyDay, TruEye|Somofilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3
35118|NCT02402127|B5|Baseline|Clariti 1day, TruEye, MyDay|Somofilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3
35119|NCT02402127|B4|Baseline|MyDay, Clariti 1day, TruEye|Stenfilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3
35122|NCT02402127|B1|Baseline|TruEye, MyDay, Clariti 1day|Narafilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3
35123|NCT02402127|P6|Participant Flow|Clariti 1day, MyDay, TruEye|Somofilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3
35124|NCT02402127|P5|Participant Flow|Clariti 1day, TruEye, MyDay|Somofilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3
35125|NCT02402127|P4|Participant Flow|MyDay, Clariti 1day, TruEye|Stenfilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3
35126|NCT02402127|P3|Participant Flow|MyDay, TruEye, Clariti 1day|Stenfilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3
35127|NCT02402127|P2|Participant Flow|TruEye, Clariti 1day, MyDay|Narafilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3
35128|NCT02402127|P1|Participant Flow|TruEye, MyDay, Clariti 1day|Narafilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3
35129|NCT02402127|O3|Outcome|Clariti 1day|Somofilcon A contact lenses
35130|NCT02402127|O2|Outcome|MyDay|Stenfilcon A contact lenses
35131|NCT02402127|O1|Outcome|TruEye|Narafilcon A contact lenses
35132|NCT02402127|O3|Outcome|Clariti 1day|Somofilcon A contact lenses worn for 16 hours in Period 1, Period 2, or Period 3
35133|NCT02402127|O2|Outcome|MyDay|Stenfilcon A contact lenses worn for 16 hours in Period 1, Period 2, or Period 3
35134|NCT02402127|O1|Outcome|TruEye|Narafilcon A contact lenses worn for 16 hours in Period 1, Period 2, or Period 3
35135|NCT02402127|E3|Reported Event|Clariti 1day|Somofilcon A contact lenses worn bilaterally for 1 day (16 hours) in Period 1, Period 2, or Period 3
35136|NCT02402127|E2|Reported Event|MyDay|Stenfilcon A contact lenses worn bilaterally for 1 day (16 hours) in Period 1, Period 2, or Period 3
35137|NCT02402127|E1|Reported Event|TruEye|Narafilcon A contact lenses worn bilaterally for 1 day (16 hours) in Period 1, Period 2, or Period 3
35138|NCT02401867|B1|Baseline|Full Sample|Descriptive characteristics for the full sample (n=150).
35139|NCT02401867|P1|Participant Flow|Overall Sample|Overall sample reported as all participants received both the self and the provider swab.
35140|NCT02401867|O2|Outcome|Participants With a Negative Cervical HPV DNA Test Result|Negative result determined by reference test: provider cervical HPV DNA Hybridization assay
35141|NCT02401867|O1|Outcome|Participants With Positive Cervical HPV DNA Test Result|Positive result determined by reference test: provider cervical HPV DNA Hybridization assay
35142|NCT02401867|E1|Reported Event|Full Sample|Descriptive characteristics for the full sample (n=150).
35143|NCT02401555|B4|Baseline|Total|Total of all reporting groups
35144|NCT02401555|B3|Baseline|Low Risk (Negatives)|"Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
35145|NCT02401555|B2|Baseline|Known AIDS|"Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
35146|NCT02401555|B1|Baseline|Known HIV1 Positives|"Individuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
35147|NCT02401555|P3|Participant Flow|Low Risk (Negatives)|"Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
35148|NCT02401555|P2|Participant Flow|Known AIDS|"Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
35149|NCT02401555|P1|Participant Flow|Known HIV1 Positives|"Individuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
35150|NCT02401555|O3|Outcome|Low Risk (Negatives)|"Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
35151|NCT02401555|O2|Outcome|Known AIDS|"Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
35152|NCT02401555|O1|Outcome|Known HIV1 Positives|"Individuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
35153|NCT02401555|E3|Reported Event|Low Risk (Negatives)|"Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
39983|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
35154|NCT02401555|E2|Reported Event|Known AIDS|"Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
35155|NCT02401555|E1|Reported Event|Known HIV1 Positives|"Individuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
35156|NCT02401529|B3|Baseline|Total|Total of all reporting groups
35157|NCT02401529|B2|Baseline|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
35158|NCT02401529|B1|Baseline|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
35159|NCT02401529|P2|Participant Flow|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
35160|NCT02401529|P1|Participant Flow|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
35161|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
35162|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
35163|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
35164|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
35165|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
35166|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~Number of participants when started 59"
35167|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
35168|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
35169|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
35170|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
35171|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
35172|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
35173|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
35174|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
35175|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
35198|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
39984|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
35176|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
35177|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
35178|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
35179|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
35180|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
35181|NCT02401529|E2|Reported Event|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
35182|NCT02401529|E1|Reported Event|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
35183|NCT02401464|B5|Baseline|Total|Total of all reporting groups
35184|NCT02401464|B4|Baseline|Granule Cohort: TAK-536 Tablet + TAK-536 Granules|Participants in Sequence b of granules formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days) followed by washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
35185|NCT02401464|B3|Baseline|Granule Cohort: TAK-536 Granules + TAK-536 Tablet|Participants in Sequence a of granules formulation received TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
35186|NCT02401464|B2|Baseline|Dry Syrup Cohort: TAK-536 Tablet + TAK-536 Dry Syrup|Participants in Sequence b of dry syrup formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
35187|NCT02401464|B1|Baseline|Dry Syrup Cohort: TAK-536 Dry Syrup + TAK-536 Tablet|Participants in Sequence a of dry syrup formulation received TAK-536 10 milligram (mg), dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
35188|NCT02401464|P4|Participant Flow|Granule Cohort: TAK-536 Tablet + TAK-536 Granules|Participants in Sequence b of granules formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days) followed by washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
35189|NCT02401464|P3|Participant Flow|Granule Cohort: TAK-536 Granules + TAK-536 Tablet|Participants in Sequence a of granules formulation received TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
35190|NCT02401464|P2|Participant Flow|Dry Syrup Cohort: TAK-536 Tablet + TAK-536 Dry Syrup|Participants in Sequence b of dry syrup formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
35191|NCT02401464|P1|Participant Flow|Dry Syrup Cohort: TAK-536 Dry Syrup + TAK-536 Tablet|Participants in Sequence a of dry syrup formulation received TAK-536 10 milligram (mg), dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
35192|NCT02401464|O4|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
35193|NCT02401464|O3|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
35194|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
35195|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
35196|NCT02401464|O4|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
35197|NCT02401464|O3|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
35860|NCT02393950|O6|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10 mg ODM-106 Capsule B.
35199|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
35200|NCT02401464|O4|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
35201|NCT02401464|O3|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
35202|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
35203|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
35204|NCT02401464|O4|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
35205|NCT02401464|O3|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
35206|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
35207|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
35208|NCT02401464|O4|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
35209|NCT02401464|O3|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
35210|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
35211|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
35212|NCT02401464|O2|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
35213|NCT02401464|O1|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
35214|NCT02401464|O2|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
35215|NCT02401464|O1|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
35216|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
35217|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
35218|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
35219|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
35220|NCT02401464|E4|Reported Event|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
35221|NCT02401464|E3|Reported Event|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
35222|NCT02401464|E2|Reported Event|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
35223|NCT02401464|E1|Reported Event|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
35224|NCT02401256|B1|Baseline|CYP2B6|A cocktail of bupropion (100mg), montelukast (10mg) and rosuvastatin (5mg). These drugs will be administrated on 3 occasions (at the begging each inpatient visit of Phase 1, 2 and 4). The study has 4 phases: Phase 1 (control, baseline)Subjects received simultaneously a cocktail of a single dose of bupropion 100 mg (CYP2b6), montelukast 10 mg (CYP2C8) and rosuvastatin 5 mg (OATP1B1/BCRP) by mouth and their metabolism and pharmacokinetics determined. Phase 2 (inhibition)a single 600 mg oral dose of efavirenz is administered with the cocktail drugs listed above and their metabolism and pharmacokinetics determined Phase 3 (home treatment with efavirenz): Subjects is taken take efavirenz for approximately 17 days Phase 4 (induction): as in phase 2. Blood samples (0 to 120 hrs) and urine voided over 48 hrs (Phases 1, 2 and 4) are collected in all phases. Blood draws is made in phase 3 for trough concentration measurements.
35239|NCT02401230|O2|Outcome|Rectal Gel Lubricant + Truvada|"Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
35240|NCT02401230|O1|Outcome|Truvada|"Subjects took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally."
35296|NCT02400580|P1|Participant Flow|Intravenous IV Acetaminophen|"The patients in the treatment arm will receive 1000mg of IV acetaminophen.~IV acetaminophen"
35225|NCT02401256|P1|Participant Flow|CYP2B6|A cocktail of bupropion (100mg), montelukast (10mg) and rosuvastatin (5mg). These drugs will be administrated on 3 occasions (at the begging each inpatient visit of Phase 1, 2 and 4). The study has 4 phases: Phase 1 (control, baseline)Subjects received simultaneously a cocktail of a single dose of bupropion 100 mg (CYP2b6), montelukast 10 mg (CYP2C8) and rosuvastatin 5 mg (OATP1B1/BCRP) by mouth and their metabolism and pharmacokinetics determined. Phase 2 (inhibition)a single 600 mg oral dose of efavirenz is administered with the cocktail drugs listed above and their metabolism and pharmacokinetics determined Phase 3 (home treatment with efavirenz): Subjects is taken take efavirenz for approximately 17 days Phase 4 (induction): as in phase 2. Blood samples (0 to 120 hrs) and urine voided over 48 hrs (Phases 1, 2 and 4) are collected in all phases. Blood draws is made in phase 3 for trough concentration measurements.
35226|NCT02401256|O3|Outcome|CYP2B6*6/*6|A cocktail of bupropion (100mg), montelukast (10mg) and rosuvastatin (5mg).These drugs will be administrated on 3 occasions (at the begging each inpatient visit of Phase 1, 2 and 4).The study has 4 phases:Phase 1(control/baseline).Subjects received simultaneously a cocktail of a single dose of bupropion 100 mg(CYP2B6), montelukast 10 mg(CYP2C8) and rosuvastatin 5 mg(OATP1B1/BCRP) by mouth and their metabolism and pharmacokinetics determined.Phase 2(inhibition)a single 600 mg oral dose of efavirenz is administered with the cocktail drugs listed above and their metabolism and pharmacokinetics determined Phase 3(home treatment with efavirenz):Subjects take efavirenz for approximately 17 days Phase 4 (induction): as in phase 2.Blood samples (0 to 120 hrs) and urine voided over 48 hrs(Phases 1, 2 and 4) are collected in all phases.Blood draws is made in phase 3 for trough concentration measurements. Volunteers were genotyped and stratified according to CYP2B6*1/*1, *1/*6, and *6/*6 alleles
35227|NCT02401256|O2|Outcome|CYP2B6*1/*6|A cocktail of bupropion (100mg), montelukast (10mg) and rosuvastatin (5mg).These drugs will be administrated on 3 occasions (at the begging each inpatient visit of Phase 1, 2 and 4).The study has 4 phases:Phase 1(control/baseline).Subjects received simultaneously a cocktail of a single dose of bupropion 100 mg(CYP2B6), montelukast 10 mg(CYP2C8) and rosuvastatin 5 mg(OATP1B1/BCRP) by mouth and their metabolism and pharmacokinetics determined.Phase 2(inhibition)a single 600 mg oral dose of efavirenz is administered with the cocktail drugs listed above and their metabolism and pharmacokinetics determined Phase 3(home treatment with efavirenz):Subjects take efavirenz for approximately 17 days Phase 4 (induction): as in phase 2.Blood samples (0 to 120 hrs) and urine voided over 48 hrs(Phases 1, 2 and 4) are collected in all phases.Blood draws is made in phase 3 for trough concentration measurements. Volunteers were genotyped and stratified according to CYP2B6*1/*1, *1/*6, and *6/*6 alleles
35228|NCT02401256|O1|Outcome|CYP2B6*1/*1|A cocktail of bupropion (100mg), montelukast (10mg) and rosuvastatin (5mg).These drugs will be administrated on 3 occasions (at the begging each inpatient visit of Phase 1, 2 and 4).The study has 4 phases:Phase 1(control/baseline).Subjects received simultaneously a cocktail of a single dose of bupropion 100 mg(CYP2B6), montelukast 10 mg(CYP2C8) and rosuvastatin 5 mg(OATP1B1/BCRP) by mouth and their metabolism and pharmacokinetics determined.Phase 2(inhibition)a single 600 mg oral dose of efavirenz is administered with the cocktail drugs listed above and their metabolism and pharmacokinetics determined Phase 3(home treatment with efavirenz):Subjects take efavirenz for approximately 17 days Phase 4 (induction): as in phase 2.Blood samples (0 to 120 hrs) and urine voided over 48 hrs(Phases 1, 2 and 4) are collected in all phases.Blood draws is made in phase 3 for trough concentration measurements. Volunteers were genotyped and stratified according to CYP2B6*1/*1, *1/*6, and *6/*6 alleles
35229|NCT02401256|E1|Reported Event|CYP2B6|A cocktail of bupropion (100mg), montelukast (10mg) and rosuvastatin (5mg). These drugs will be administrated on 3 occasions (at the begging each inpatient visit of Phase 1, 2 and 4). The study has 4 phases: Phase 1 (control, baseline)Subjects received simultaneously a cocktail of a single dose of bupropion 100 mg (CYP2b6), montelukast 10 mg (CYP2C8) and rosuvastatin 5 mg (OATP1B1/BCRP) by mouth and their metabolism and pharmacokinetics determined. Phase 2 (inhibition)a single 600 mg oral dose of efavirenz is administered with the cocktail drugs listed above and their metabolism and pharmacokinetics determined Phase 3 (home treatment with efavirenz): Subjects is taken take efavirenz for approximately 17 days Phase 4 (induction): as in phase 2. Blood samples (0 to 120 hrs) and urine voided over 48 hrs (Phases 1, 2 and 4) are collected in all phases. Blood draws is made in phase 3 for trough concentration measurements.
35230|NCT02401230|B4|Baseline|Total|Total of all reporting groups
35231|NCT02401230|B3|Baseline|Rectal Gel Lubricant + Truvada|"Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
35232|NCT02401230|B2|Baseline|Truvada|"Subjects took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally."
35233|NCT02401230|B1|Baseline|Rectal Gel Lubricant|"Subjects inserted 5 mL of lubricant in rectum for seven consecutive days~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
35234|NCT02401230|P3|Participant Flow|Rectal Gel Lubricant + Truvada|"Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
35235|NCT02401230|P2|Participant Flow|Truvada|"Subjects took one Truvada tablet orally for seven consecutive days.~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally."
35236|NCT02401230|P1|Participant Flow|Rectal Gel Lubricant|"Subjects inserted 5 mL of lubricant in rectum for seven consecutive days.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
35237|NCT02401230|O2|Outcome|Rectal Gel Lubricant + Truvada|"Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
35238|NCT02401230|O1|Outcome|Truvada|"Subjects took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally."
35292|NCT02400580|B3|Baseline|Total|Total of all reporting groups
35293|NCT02400580|B2|Baseline|Normal Saline|"The patients in the placebo arm will receive normal saline.~placebo"
35241|NCT02401230|O2|Outcome|Rectal Gel Lubricant + Truvada|"Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
35242|NCT02401230|O1|Outcome|Truvada|"Subjects took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally."
35243|NCT02401230|O2|Outcome|Rectal Gel Lubricant + Truvada|"Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
35244|NCT02401230|O1|Outcome|Truvada|"Subjects took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally."
35245|NCT02401230|O2|Outcome|Rectal Gel Lubricant + Truvada|"Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
35246|NCT02401230|O1|Outcome|Truvada|"Subjects took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally."
35247|NCT02401230|O2|Outcome|Rectal Gel Lubricant + Truvada|"Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
35248|NCT02401230|O1|Outcome|Truvada|"Subjects took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally."
35249|NCT02401230|O2|Outcome|Rectal Gel Lubricant + Truvada|"Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
35250|NCT02401230|O1|Outcome|Truvada|"Subjects took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally."
35251|NCT02401230|O2|Outcome|Rectal Gel Lubricant + Truvada|"Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
35252|NCT02401230|O1|Outcome|Truvada|"Subjects took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally."
35253|NCT02401230|O2|Outcome|Rectal Gel Lubricant + Truvada|"Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
35254|NCT02401230|O1|Outcome|Truvada|"Subjects took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally."
35255|NCT02401230|O2|Outcome|Rectal Gel Lubricant + Truvada|"Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
35256|NCT02401230|O1|Outcome|Truvada|"Subjects took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally."
35257|NCT02401230|O2|Outcome|Rectal Gel Lubricant + Truvada|"Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
35258|NCT02401230|O1|Outcome|Truvada|"Subjects took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally."
35259|NCT02401230|O3|Outcome|Rectal Gel Lubricant + Truvada|"Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
35260|NCT02401230|O2|Outcome|Truvada|"Subjects took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally."
35261|NCT02401230|O1|Outcome|Rectal Gel Lubricant|"Subjects inserted 5 mL of lubricant in rectum for seven consecutive days~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
35262|NCT02401230|O3|Outcome|Rectal Gel Lubricant + Truvada|"Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
35263|NCT02401230|O2|Outcome|Truvada|"Subjects took one Truvada tablet orally for seven consecutive days.~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally."
35264|NCT02401230|O1|Outcome|Rectal Gel Lubricant|"Subjects inserted 5 mL of lubricant in rectum for seven consecutive days.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
35297|NCT02400580|O2|Outcome|Normal Saline|"The patients in the placebo arm will receive normal saline.~placebo"
35265|NCT02401230|E3|Reported Event|Rectal Gel Lubricant + Truvada|"Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
35266|NCT02401230|E2|Reported Event|Truvada|"Subjects took one Truvada tablet orally for seven consecutive days.~Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally."
35267|NCT02401230|E1|Reported Event|Rectal Gel Lubricant|"Subjects inserted 5 mL of lubricant in rectum for seven consecutive days.~Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator."
35268|NCT02401022|B3|Baseline|Total|Total of all reporting groups
35269|NCT02401022|B2|Baseline|AZD8529 High Dose|Participants received AZD8529 40 mg capsule orally once daily for 13 weeks
35270|NCT02401022|B1|Baseline|AZD8529 Low Dose|Participants received AZD8529 1.5 mg capsule orally once daily for 13 weeks
35271|NCT02401022|P2|Participant Flow|AZD8529 High Dose|Participants received AZD8529 40 mg capsule orally once daily for 13 weeks
35272|NCT02401022|P1|Participant Flow|AZD8529 Low Dose|Participants received AZD8529 1.5 mg capsule orally once daily for 13 weeks
35273|NCT02401022|O2|Outcome|AZD8529 High Dose|Participants received AZD8529 40 mg capsule orally once daily for 13 weeks
35274|NCT02401022|O1|Outcome|AZD8529 Low Dose|Participants received AZD8529 1.5 mg capsule orally once daily for 13 weeks
35275|NCT02401022|E2|Reported Event|AZD8529 High Dose|Participants received AZD8529 40 mg capsule orally once daily for 13 weeks
35276|NCT02401022|E1|Reported Event|AZD8529 Low Dose|Participants received AZD8529 1.5 mg capsule orally once daily for 13 weeks
35277|NCT02400996|B1|Baseline|Patients Operated for Pancreatic Endocrine Neoplasms|We did an observational analysis from a prospectively maintained database of patients who underwent pancreatic surgery for neoplasms of the pancreas at Sir Ganga Ram Hospital, New Delhi, India from 1995 to 2013 and using pathological reports and preoperative CT scan as gold standard, we identified 40 patients with PENs.
35278|NCT02400996|P1|Participant Flow|Patients Operated for Pancreatic Endocrine Neoplasms|We did an observational analysis from a prospectively maintained database of patients who underwent pancreatic surgery for neoplasms of the pancreas at Sir Ganga Ram Hospital, New Delhi, India from 1995 to 2013 and using pathological reports and preoperative CT scan as gold standard, we identified 40 patients with PENs.
35279|NCT02400996|O1|Outcome|Patients Operated for Pancreatic Endocrine Neoplasms|We did an observational analysis from a prospectively maintained database of patients who underwent pancreatic surgery for neoplasms of the pancreas at Sir Ganga Ram Hospital, New Delhi, India from 1995 to 2013 and using pathological reports and preoperative CT scan as gold standard, we identified 40 patients with PENs.
35280|NCT02400996|E1|Reported Event|Pancreatic Endocrine Neoplasms|We did an observational analysis from a prospectively maintained database of patients who underwent pancreatic surgery for neoplasms of the pancreas at Sir Ganga Ram Hospital, New Delhi, India from 1995 to 2013 and using pathological reports and preoperative CT scan as gold standard, we identified 40 patients with PENs.
35281|NCT02400710|B3|Baseline|Total|Total of all reporting groups
35282|NCT02400710|B2|Baseline|Self-Managed PTSD Coach|"One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.~Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app."
35283|NCT02400710|B1|Baseline|Clinician-Supported PTSD Coach|"Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.~Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care."
35284|NCT02400710|P2|Participant Flow|Self-Managed PTSD Coach|"One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.~Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app."
35285|NCT02400710|P1|Participant Flow|Clinician-Supported PTSD Coach|"Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.~Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care."
35286|NCT02400710|O2|Outcome|Self-Managed PTSD Coach|"One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.~Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app."
35287|NCT02400710|O1|Outcome|Clinician-Supported PTSD Coach|"Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.~Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care."
35288|NCT02400710|O2|Outcome|Self-Managed PTSD Coach|"One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.~Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app."
35289|NCT02400710|O1|Outcome|Clinician-Supported PTSD Coach|"Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.~Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care."
35290|NCT02400710|E2|Reported Event|Self-Managed PTSD Coach|"One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.~Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app."
35291|NCT02400710|E1|Reported Event|Clinician-Supported PTSD Coach|"Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.~Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care."
35298|NCT02400580|O1|Outcome|Intravenous IV Acetaminophen|"The patients in the treatment arm will receive 1000mg of IV acetaminophen.~IV acetaminophen"
35299|NCT02400580|O2|Outcome|Normal Saline|"The patients in the placebo arm will receive normal saline.~placebo"
35300|NCT02400580|O1|Outcome|Intravenous IV Acetaminophen|"The patients in the treatment arm will receive 1000mg of IV acetaminophen.~IV acetaminophen"
35301|NCT02400580|O2|Outcome|Normal Saline|"The patients in the placebo arm will receive normal saline.~placebo"
35302|NCT02400580|O1|Outcome|Intravenous IV Acetaminophen|"The patients in the treatment arm will receive 1000mg of IV acetaminophen.~IV acetaminophen"
35303|NCT02400580|E2|Reported Event|Normal Saline|"The patients in the placebo arm will receive normal saline.~placebo"
35304|NCT02400580|E1|Reported Event|Intravenous IV Acetaminophen|"The patients in the treatment arm will receive 1000mg of IV acetaminophen.~IV acetaminophen"
35305|NCT02400346|B1|Baseline|Adjunct Brexpiprazole|"All patients continued their current antidepressant treatment and received brexpiprazole open-label in addition.~Adjunct brexpiprazole administration was flexible and included a titration period: Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.~Tablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg."
35306|NCT02400346|P1|Participant Flow|Adjunct Brexpiprazole|"All patients continued their current antidepressant treatment and received brexpiprazole open-label in addition.~Adjunct brexpiprazole administration was flexible and included a titration period: Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.~Tablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg."
35307|NCT02400346|O1|Outcome|Adjunct Brexpiprazole|"All patients continued their current antidepressant treatment and received brexpiprazole open-label in addition.~Adjunct brexpiprazole administration was flexible and included a titration period: Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.~Tablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg."
35308|NCT02400346|E1|Reported Event|Brex + ADT|
35309|NCT02400333|B5|Baseline|Total|Total of all reporting groups
35310|NCT02400333|B4|Baseline|DCAB Sequence|Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4.
35311|NCT02400333|B3|Baseline|CBDA Sequence|Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4.
35312|NCT02400333|B2|Baseline|BACD Sequence|Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4.
35313|NCT02400333|B1|Baseline|ADBC Sequence|Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4.
35314|NCT02400333|P4|Participant Flow|DCAB Sequence|Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4.
35315|NCT02400333|P3|Participant Flow|CBDA Sequence|Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4.
35316|NCT02400333|P2|Participant Flow|BACD Sequence|Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4.
35317|NCT02400333|P1|Participant Flow|ADBC Sequence|Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4.
35318|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
35319|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
35320|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
35321|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
35322|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
35323|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
35324|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
35325|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
35326|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
35327|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
35328|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
35329|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
35330|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
35331|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
35332|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
35333|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
35334|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
35335|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
35336|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
35337|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
35338|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
35339|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
35340|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
35341|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
35342|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
35343|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
35344|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
35345|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
35346|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
35347|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
35348|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
35349|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
35350|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
35351|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
35352|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
35353|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
35354|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
35355|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
35356|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
35357|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
35358|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
35359|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
35360|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
35361|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
35362|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
35363|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
35364|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
35365|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
35366|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
35367|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a nasogastric tube (NG) tube into the stomach (total of 200 mL of water).
35368|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
35369|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
35370|NCT02400333|E4|Reported Event|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
35371|NCT02400333|E3|Reported Event|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
35372|NCT02400333|E2|Reported Event|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
35373|NCT02400333|E1|Reported Event|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
35374|NCT02399345|B1|Baseline|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
35375|NCT02399345|P1|Participant Flow|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
35376|NCT02399345|O1|Outcome|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
35377|NCT02399345|O1|Outcome|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
35378|NCT02399345|O1|Outcome|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
35379|NCT02399345|E1|Reported Event|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
35380|NCT02399163|B1|Baseline|Overall Participants|All randomized participants were evaluated for baseline characteristics
35381|NCT02399163|P1|Participant Flow|Overall Study|"In this cross-over study, participants were randomized to receive each of following treatments:~Fluoride dentifrice/Fluoride rinse~Placebo dentifrice/Fluoride rinse~Fluoride dentifrice/No rinse~Placebo dentifrice/No rinse"
35382|NCT02399163|O4|Outcome|Fluoride Dentifrice/Fluoride Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
35383|NCT02399163|O3|Outcome|Fluoride Dentifrice/No Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
35384|NCT02399163|O2|Outcome|Placebo Dentifrice/No Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste
35385|NCT02399163|O1|Outcome|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
35386|NCT02399163|O4|Outcome|Fluoride Dentifrice/Fluoride Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.
35387|NCT02399163|O3|Outcome|Fluoride Dentifrice/No Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
35388|NCT02399163|O2|Outcome|Placebo Dentifrice/No Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste
35389|NCT02399163|O1|Outcome|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
35390|NCT02399163|O4|Outcome|Fluoride Dentifrice/Fluoride Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.
35391|NCT02399163|O3|Outcome|Fluoride Dentifrice/No Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
35392|NCT02399163|O2|Outcome|Placebo Dentifrice/No Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste
35393|NCT02399163|O1|Outcome|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
35394|NCT02399163|O4|Outcome|Fluoride Dentifrice/Fluoride Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.
35395|NCT02399163|O3|Outcome|Fluoride Dentifrice/No Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
35396|NCT02399163|O2|Outcome|Placebo Dentifrice/No Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste
35397|NCT02399163|O1|Outcome|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
35398|NCT02399163|O2|Outcome|Placebo Dentifrice/No Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste
35399|NCT02399163|O1|Outcome|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 parts per million (ppm) of fluoride as sodium fluoride
35439|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35400|NCT02399163|E4|Reported Event|Fluoride Dentifrice/Fluoride Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.
35401|NCT02399163|E3|Reported Event|Fluoride Dentifrice/No Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
35402|NCT02399163|E2|Reported Event|Placebo Dentifrice/No Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste
35403|NCT02399163|E1|Reported Event|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
35404|NCT02399111|B5|Baseline|Total|Total of all reporting groups
35405|NCT02399111|B4|Baseline|Obese:BMI≥30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
35406|NCT02399111|B3|Baseline|Not Obese:BMI<30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
35407|NCT02399111|B2|Baseline|Obese:BMI≥30; Standard Care|Obese:BMI≥30;Standard Wound Care
35408|NCT02399111|B1|Baseline|Not Obese:BMI<30; Standard Care|Not obese:BMI<30;Standard Wound Care
35409|NCT02399111|P4|Participant Flow|Obese:BMI≥30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
35410|NCT02399111|P3|Participant Flow|Not Obese:BMI<30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
35411|NCT02399111|P2|Participant Flow|Obese:BMI≥30; Standard Care|Obese: BMI ≥30; Standard Wound Care
35412|NCT02399111|P1|Participant Flow|Not Obese:BMI<30; Standard Care|Not obese: BMI< 30; Standard Wound Care
35413|NCT02399111|O4|Outcome|Obese:BMI≥30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
35414|NCT02399111|O3|Outcome|Not Obese:BMI<30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
35415|NCT02399111|O2|Outcome|Obese:BMI≥30; Standard Care|Standard Wound Care
35416|NCT02399111|O1|Outcome|Not Obese:BMI<30; Standard Care|Standard Wound Care
35440|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35441|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35442|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35417|NCT02399111|O4|Outcome|Obese:BMI≥30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
35418|NCT02399111|O3|Outcome|Not Obese:BMI<30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
35419|NCT02399111|O2|Outcome|Obese:BMI≥30; Standard Care|Obese:BMI≥30;Standard Wound Care
35420|NCT02399111|O1|Outcome|Not Obese:BMI<30; Standard Care|Not obese:BMI<30;Standard Wound Care
35421|NCT02399111|E4|Reported Event|Obese:BMI≥30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
35422|NCT02399111|E3|Reported Event|Not Obese:BMI<30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
35423|NCT02399111|E2|Reported Event|Obese:BMI≥30; Standard Care|Obese:BMI≥30;Standard Wound Care
35424|NCT02399111|E1|Reported Event|Not Obese:BMI<30; Standard Care|Not obese:BMI<30;Standard Wound Care
35425|NCT02397915|B1|Baseline|FF 110 µg /MF 200 µg or MF 200 µg /FF 110 µg|All participants received treatments in one of two treatment sequences, Sequence 1: two sprays of FF (total of 110 µg) in each nostril (total 4 sprays) in Period 1 and two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) in Period 2; Sequence 2: FF (110 µg) followed by MF (total of 200 µg) and MF (total of 200 µg) followed by FF (110 µg) in Period 2. Two study treatments were administered 30 minutes (+/-5) apart by a third party administrator using a metered nasal spray.
35426|NCT02397915|P4|Participant Flow|Period 2: FF 110 µg|Participants received FF (total dose of 110 µg) in each nostril (total 4 sprays).
35427|NCT02397915|P3|Participant Flow|Period 2: MF 200 µg|Participants received two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays).
35428|NCT02397915|P2|Participant Flow|Period 1: MF 200 µg|Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays). Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
35429|NCT02397915|P1|Participant Flow|Period 1: FF 110 µg|Participants received two sprays of FF (total dose of 110 micrograms [µg]) in each nostril (total 4 sprays). Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
35430|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35431|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35432|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35433|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35434|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35435|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35436|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35437|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35438|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35861|NCT02393950|O5|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100 mg ODM-106 Capsule B.
35443|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35444|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35445|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35446|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35447|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35448|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35449|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35450|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35451|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35452|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35453|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35454|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35455|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35456|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35457|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35458|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35459|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35460|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35461|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35462|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35463|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35464|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35465|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35466|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35467|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35468|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35469|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35470|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35471|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35472|NCT02397915|O2|Outcome|MF 200 µg /FF 110 µg|Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
35473|NCT02397915|O1|Outcome|FF 110 µg /MF 200 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
35474|NCT02397915|O2|Outcome|MF 200 µg /FF 110 µg|Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
35654|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35475|NCT02397915|O1|Outcome|FF 110 µg /MF 200 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
35476|NCT02397915|E2|Reported Event|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35477|NCT02397915|E1|Reported Event|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
35478|NCT02397785|B3|Baseline|Total|Total of all reporting groups
35479|NCT02397785|B2|Baseline|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
35480|NCT02397785|B1|Baseline|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
35481|NCT02397785|P2|Participant Flow|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
35482|NCT02397785|P1|Participant Flow|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
35483|NCT02397785|O2|Outcome|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
35484|NCT02397785|O1|Outcome|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
35485|NCT02397785|O2|Outcome|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
35486|NCT02397785|O1|Outcome|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
35626|NCT02396160|O1|Outcome|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
39985|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
35487|NCT02397785|O2|Outcome|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
35488|NCT02397785|O1|Outcome|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
35489|NCT02397785|O2|Outcome|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
35490|NCT02397785|O1|Outcome|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
35491|NCT02397785|O2|Outcome|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
35492|NCT02397785|O1|Outcome|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
35493|NCT02397785|O2|Outcome|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
35494|NCT02397785|O1|Outcome|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
35495|NCT02397785|O2|Outcome|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
35538|NCT02397694|O2|Outcome|DTG + F/TAF|DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
35842|NCT02394457|E1|Reported Event|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
35496|NCT02397785|O1|Outcome|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
35497|NCT02397785|O2|Outcome|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
35498|NCT02397785|O1|Outcome|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
35499|NCT02397785|O2|Outcome|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
35500|NCT02397785|O1|Outcome|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
35501|NCT02397785|O2|Outcome|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
35502|NCT02397785|O1|Outcome|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
35503|NCT02397785|O2|Outcome|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
35504|NCT02397785|O1|Outcome|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
35539|NCT02397694|O1|Outcome|BIC + F/TAF|BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
35843|NCT02393950|B3|Baseline|Total|Total of all reporting groups
35505|NCT02397785|O2|Outcome|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
35506|NCT02397785|O1|Outcome|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
35507|NCT02397785|O2|Outcome|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
35508|NCT02397785|O1|Outcome|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
35509|NCT02397785|O2|Outcome|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
35510|NCT02397785|O1|Outcome|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
35511|NCT02397785|O2|Outcome|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
35512|NCT02397785|O1|Outcome|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
35513|NCT02397785|O2|Outcome|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
35540|NCT02397694|O2|Outcome|DTG + F/TAF|DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
35844|NCT02393950|B2|Baseline|Panel 2|Single oral doses ODM-106 Capsule B 100, 100, 200 mg. ODM-106 Capsule A 100mg, placebo
35514|NCT02397785|O1|Outcome|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
35515|NCT02397785|O2|Outcome|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
35516|NCT02397785|O1|Outcome|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
35517|NCT02397785|O2|Outcome|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
35518|NCT02397785|O1|Outcome|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
35519|NCT02397785|O2|Outcome|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
35520|NCT02397785|O1|Outcome|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
35521|NCT02397785|O2|Outcome|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
35522|NCT02397785|O1|Outcome|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
35541|NCT02397694|O1|Outcome|BIC + F/TAF|BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
39986|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
35523|NCT02397785|E2|Reported Event|Sham Device|"Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered on, the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week."
35524|NCT02397785|E1|Reported Event|ApexM Device|InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
35525|NCT02397694|B3|Baseline|Total|Total of all reporting groups
35526|NCT02397694|B2|Baseline|DTG + F/TAF|DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
35527|NCT02397694|B1|Baseline|BIC + F/TAF|BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
35528|NCT02397694|P2|Participant Flow|DTG + F/TAF|DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
35529|NCT02397694|P1|Participant Flow|BIC + F/TAF|Bictegravir (BIC) 75 mg + emtricitabine/tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) + dolutegravir (DTG) placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing BIC 50 mg, FTC 200 mg, and TAF 25 mg (B/F/TAF).
35530|NCT02397694|O2|Outcome|DTG + F/TAF|DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
35531|NCT02397694|O1|Outcome|BIC + F/TAF|BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
35532|NCT02397694|O2|Outcome|DTG + F/TAF|DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
35533|NCT02397694|O1|Outcome|BIC + F/TAF|BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
35534|NCT02397694|O2|Outcome|DTG + F/TAF|DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
35535|NCT02397694|O1|Outcome|BIC + F/TAF|BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
35536|NCT02397694|O2|Outcome|DTG + F/TAF|DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
35537|NCT02397694|O1|Outcome|BIC + F/TAF|BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
35845|NCT02393950|B1|Baseline|Panel 1|Single oral doses ODM-106 Capsule B 2, 10, 25, 50mg, placebo
35542|NCT02397694|O2|Outcome|DTG + F/TAF|DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
35543|NCT02397694|O1|Outcome|BIC + F/TAF|BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
35544|NCT02397694|O2|Outcome|DTG + F/TAF|DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
35545|NCT02397694|O1|Outcome|BIC + F/TAF|BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
35546|NCT02397694|O2|Outcome|DTG + F/TAF|DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
35547|NCT02397694|O1|Outcome|BIC + F/TAF|BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
35548|NCT02397694|O2|Outcome|DTG + F/TAF|DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
35549|NCT02397694|O1|Outcome|BIC + F/TAF|BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
35550|NCT02397694|O2|Outcome|DTG + F/TAF|DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
35551|NCT02397694|O1|Outcome|BIC + F/TAF|BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
35552|NCT02397694|O2|Outcome|DTG + F/TAF|DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
35553|NCT02397694|O1|Outcome|BIC + F/TAF|BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
35554|NCT02397694|O2|Outcome|DTG + F/TAF|DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
35555|NCT02397694|O1|Outcome|BIC + F/TAF|BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
35556|NCT02397694|O2|Outcome|DTG + F/TAF|DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
35557|NCT02397694|O1|Outcome|BIC + F/TAF|BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
39987|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
35558|NCT02397694|O2|Outcome|DTG + F/TAF|DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
35559|NCT02397694|O1|Outcome|BIC + F/TAF|BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
35560|NCT02397694|O2|Outcome|DTG + F/TAF|DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
35561|NCT02397694|O1|Outcome|BIC + F/TAF|BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
35562|NCT02397694|E4|Reported Event|DTG + F/TAF to B/F/TAF (Open-Label Phase)|Adverse events in this reporting group include all participants who received B/F/TAF during the open-label phase. Participants received B/F/TAF (50/200/25 mg) FDC during the open-label phase.
35563|NCT02397694|E3|Reported Event|BIC + F/TAF to B/F/TAF (Open-Label Phase)|Adverse events in this reporting group include those that occurred during the open-label phase by participants randomized to BIC + FTC/TAF. Participants received B/F/TAF (50/200/25 mg) FDC during the open-label phase.
35564|NCT02397694|E2|Reported Event|DTG + F/TAF (Double Blind Randomized):|Adverse events in this reporting group include those that occurred during the double-blind phase by participants randomized to DTG + FTC/TAF. Participants received DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily.
35565|NCT02397694|E1|Reported Event|BIC + F/TAF (Double-Blind Randomized)|Adverse events in this reporting group include those that occurred during the double-blind phase by participants randomized to BIC + F/TAF. Participants received BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks.
35566|NCT02397655|B1|Baseline|Overall Study|This cross sectional study was totally enrolled 12012 cases. After excluded 1301 cases whose basic clinical information and/or ultrasound examination data not completed, a total of 10711 cases were entered into the final statistical analysis.
35567|NCT02397655|P1|Participant Flow|Overall Study|This cross sectional study was totally enrolled 12012 cases. After excluded 1301 cases whose basic clinical information and/or ultrasound examination data not completed, a total of 10711 cases were entered into the final statistical analysis.
35568|NCT02397655|O1|Outcome|Overall Study|This cross sectional study was totally enrolled 12012 cases. After excluded 1301 cases whose basic clinical information and/or ultrasound examination data not completed, a total of 10711 cases were entered into the final statistical analysis.
35569|NCT02397655|E1|Reported Event|Overall Study|This cross sectional study was totally enrolled 12012 cases. After excluded 1301 cases whose basic clinical information and/or ultrasound examination data not completed, a total of 10711 cases were entered into the final statistical analysis.
35570|NCT02397564|B1|Baseline|Treatment Group|"Enroll 20 patients for nonsurgical treatment of surgical scars. Half of each scar will be treated with the Er:YAG laser on the traditional ablative setting and the other half of the scar will receive Er:YAG treatment with the fractional ablative setting. The patients will receive 3 treatments at monthly intervals. They will follow up at 1 and 2 months after the treatment.~Er:YAG laser, traditional and fractional settings: Half the scar will be treated with traditional ablative setting and the other half will be treated with the fractional ablative setting"
35571|NCT02397564|P1|Participant Flow|Intervention Group|"Enroll 20 patients for nonsurgical treatment of surgical scars. Half of each scar will be treated with the Er:YAG laser on the traditional ablative setting and the other half of the scar will receive Er:YAG treatment with the fractional ablative setting. The patients will receive 3 treatments at monthly intervals. They will follow up at 1 and 2 months after the treatment.~Er:YAG laser, traditional and fractional settings: Half the scar will be treated with traditional ablative setting and the other half will be treated with the fractional ablative setting"
35572|NCT02397564|O1|Outcome|Treatment Group|Number of patients that preferred the fractionated laser.
35573|NCT02397564|O1|Outcome|Treatment Group|Subjects receiving treatment for scar
35574|NCT02397564|E1|Reported Event|Treatment Group|Those who went laser treatment.
35575|NCT02397122|B3|Baseline|Total|Total of all reporting groups
35576|NCT02397122|B2|Baseline|CAF+CTG|A computer-generated randomization scheme (simple randomization without any blocking) was used to assign 20 patients into each study groups with an allocation ratio of 1:1
35577|NCT02397122|B1|Baseline|CAF+CTG+PRF|A computer-generated randomization scheme (simple randomization without any blocking) was used to assign 20 patients into each study groups with an allocation ratio of 1:1
35578|NCT02397122|P2|Participant Flow|CAF+CTG|"coronally advanced flap + connective tissue graft~connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method~coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft"
35579|NCT02397122|P1|Participant Flow|CAF+CTG+PRF|"platelet-rich fibrin + coronally advanced flap + connective tissue graft~platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods~connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method~coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)"
35627|NCT02396160|O2|Outcome|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
35580|NCT02397122|O2|Outcome|CAF+CTG|A computer-generated randomization scheme (simple randomization without any blocking) was used to assign 20 patients into each study groups with an allocation ratio of 1:1. After phase I therapy, the patients were surgically treated with coronally advanced flap (CAF)+connective tissue graft(CTG). Surgical incisions involving sulcular and adjacent vertical incisions were made and split-full-split flaps were elevated. CTG was harvested from the palate and placed over the recession defect. Flap was coronally advanced and CTG was completely closed. Extraoral cold compress and analgesic plus antiinflammatory drugs (Ibuprofen, 100 mg, twice a day) were given for pain and edema control. Toothbrushing in the surgical region was prohibited for 4 weeks; instead, antiseptic solution (Chlorhexidine gluconate) was prescribed.
35581|NCT02397122|O1|Outcome|CAF+CTG+PRF|A computer-generated randomization scheme (simple randomization without any blocking) was used to assign 20 patients into each study groups with an allocation ratio of 1:1. After phase I therapy, the patients were surgically treated with coronally advanced flap (CAF)+connective tissue graft(CTG)+platelet-rich fibrin(PRF). Surgical incisions involving sulcular and adjacent vertical incisions were made and split-full-split flaps were elevated. PRF was prepared from 10 ml venous blood and the gel part was placed under CTG harvested from the palate. Flap was coronally advanced and CTG+PRF was completely closed. Extraoral cold compress and analgesic plus antiinflammatory drugs (Ibuprofen, 100 mg, twice a day) were given for pain and edema control. Toothbrushing in the surgical region was prohibited for 4 weeks; instead, antiseptic solution (Chlorhexidine gluconate) was prescribed.
35582|NCT02397122|O2|Outcome|CAF+CTG|A computer-generated randomization scheme (simple randomization without any blocking) was used to assign 20 patients into each study groups with an allocation ratio of 1:1. After phase I therapy, the patients were surgically treated with coronally advanced flap (CAF)+connective tissue graft(CTG). Surgical incisions involving sulcular and adjacent vertical incisions were made and split-full-split flaps were elevated. CTG was harvested from the palate and placed over the recession defect. Flap was coronally advanced and CTG was completely closed. Extraoral cold compress and analgesic plus antiinflammatory drugs (Ibuprofen, 100 mg, twice a day) were given for pain and edema control. Toothbrushing in the surgical region was prohibited for 4 weeks; instead, antiseptic solution (Chlorhexidine gluconate) was prescribed.
35583|NCT02397122|O1|Outcome|CAF+CTG+PRF|A computer-generated randomization scheme (simple randomization without any blocking) was used to assign 20 patients into each study groups with an allocation ratio of 1:1. After phase I therapy, the patients were surgically treated with coronally advanced flap (CAF)+connective tissue graft(CTG)+platelet-rich fibrin(PRF). Surgical incisions involving sulcular and adjacent vertical incisions were made and split-full-split flaps were elevated. PRF was prepared from 10 ml venous blood and the gel part was placed under CTG harvested from the palate. Flap was coronally advanced and CTG+PRF was completely closed. Extraoral cold compress and analgesic plus antiinflammatory drugs (Ibuprofen, 100 mg, twice a day) were given for pain and edema control. Toothbrushing in the surgical region was prohibited for 4 weeks; instead, antiseptic solution (Chlorhexidine gluconate) was prescribed.
35584|NCT02397122|O2|Outcome|CAF+CTG|A computer-generated randomization scheme (simple randomization without any blocking) was used to assign 20 patients into each study groups with an allocation ratio of 1:1. After phase I therapy, the patients were surgically treated with coronally advanced flap (CAF)+connective tissue graft(CTG). Surgical incisions involving sulcular and adjacent vertical incisions were made and split-full-split flaps were elevated. CTG was harvested from the palate and placed over the recession defect. Flap was coronally advanced and CTG was completely closed. Extraoral cold compress and analgesic plus antiinflammatory drugs (Ibuprofen, 100 mg, twice a day) were given for pain and edema control. Toothbrushing in the surgical region was prohibited for 4 weeks; instead, antiseptic solution (Chlorhexidine gluconate) was prescribed.
35585|NCT02397122|O1|Outcome|CAF+CTG+PRF|A computer-generated randomization scheme (simple randomization without any blocking) was used to assign 20 patients into each study groups with an allocation ratio of 1:1. After phase I therapy, the patients were surgically treated with coronally advanced flap (CAF)+connective tissue graft(CTG)+platelet-rich fibrin(PRF). Surgical incisions involving sulcular and adjacent vertical incisions were made and split-full-split flaps were elevated. PRF was prepared from 10 ml venous blood and the gel part was placed under CTG harvested from the palate. Flap was coronally advanced and CTG+PRF was completely closed. Extraoral cold compress and analgesic plus antiinflammatory drugs (Ibuprofen, 100 mg, twice a day) were given for pain and edema control. Toothbrushing in the surgical region was prohibited for 4 weeks; instead, antiseptic solution (Chlorhexidine gluconate) was prescribed.
35586|NCT02397122|O2|Outcome|CAF+CTG|A computer-generated randomization scheme (simple randomization without any blocking) was used to assign 20 patients into each study groups with an allocation ratio of 1:1. After phase I therapy, the patients were surgically treated with coronally advanced flap (CAF)+connective tissue graft(CTG). Surgical incisions involving sulcular and adjacent vertical incisions were made and split-full-split flaps were elevated. CTG was harvested from the palate and placed over the recession defect. Flap was coronally advanced and CTG was completely closed. Extraoral cold compress and analgesic plus antiinflammatory drugs (Ibuprofen, 100 mg, twice a day) were given for pain and edema control. Toothbrushing in the surgical region was prohibited for 4 weeks; instead, antiseptic solution (Chlorhexidine gluconate) was prescribed.
35587|NCT02397122|O1|Outcome|CAF+CTG+PRF|A computer-generated randomization scheme (simple randomization without any blocking) was used to assign 20 patients into each study groups with an allocation ratio of 1:1. After phase I therapy, the patients were surgically treated with coronally advanced flap (CAF)+connective tissue graft(CTG)+platelet-rich fibrin(PRF). Surgical incisions involving sulcular and adjacent vertical incisions were made and split-full-split flaps were elevated. PRF was prepared from 10 ml venous blood and the gel part was placed under CTG harvested from the palate. Flap was coronally advanced and CTG+PRF was completely closed. Extraoral cold compress and analgesic plus antiinflammatory drugs (Ibuprofen, 100 mg, twice a day) were given for pain and edema control. Toothbrushing in the surgical region was prohibited for 4 weeks; instead, antiseptic solution (Chlorhexidine gluconate) was prescribed.
35588|NCT02397122|O2|Outcome|CAF+CTG|"platelet-rich fibrin + coronally advanced flap + connective tissue graft~platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods~connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method~coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft"
35846|NCT02393950|P2|Participant Flow|Panel 2|Single oral doses ODM-106 Capsule B: 100, 100, 200mg. ODM-106 Capsule A 100 mg , placebo
35589|NCT02397122|O1|Outcome|CAF+CTG+PRF|"platelet-rich fibrin + coronally advanced flap + connective tissue graft~platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods~connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method~coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)"
35590|NCT02397122|O2|Outcome|CAF+CTG|"platelet-rich fibrin + coronally advanced flap + connective tissue graft~platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods~connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method~coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)"
35591|NCT02397122|O1|Outcome|PRF+CAF+CTG|"platelet-rich fibrin + coronally advanced flap + connective tissue graft~platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods~connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method~coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)"
35592|NCT02397122|E2|Reported Event|CAF+CTG|"coronally advanced flap + connective tissue graft~connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method~coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft"
35593|NCT02397122|E1|Reported Event|PRF+CAF+CTG|"platelet-rich fibrin + coronally advanced flap + connective tissue graft~platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods~connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method~coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)"
35594|NCT02396537|B3|Baseline|Total|Total of all reporting groups
35595|NCT02396537|B2|Baseline|Intranasal 0.9% Saline|"Patient to receive 0.9% Saline intranasally prior to midazolam~Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered.~0.9% Saline: Administered intranasally prior to Midazolam administration."
35596|NCT02396537|B1|Baseline|Intranasal Lidocaine|"Patient to receive 4% lidocaine intranasally prior to midazolam~Lidocaine: Administered intranasally prior to Midazolam administration.~Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered."
35597|NCT02396537|P2|Participant Flow|Intranasal 0.9% Saline|"Patient to receive 0.9% Saline intranasally prior to midazolam~Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered.~0.9% Saline: Administered intranasally prior to Midazolam administration."
35598|NCT02396537|P1|Participant Flow|Intranasal Lidocaine|"Patient to receive 4% lidocaine intranasally prior to midazolam~Lidocaine: Administered intranasally prior to Midazolam administration.~Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered."
35599|NCT02396537|O2|Outcome|Intranasal 0.9% Saline|Subjects were administered 0.9% saline, 0.5 ml in each naris, 5 minutes prior to intranasal midazolam (placebo group).
35600|NCT02396537|O1|Outcome|Intranasal Lidocaine|Subjects were administered 4% lidocaine solution, 0.5 ml in each naris, 5 minutes prior to intranasal midazolam (intervention group).
35601|NCT02396537|E2|Reported Event|Intranasal 0.9% Saline|"Patient to receive 0.9% Saline intranasally prior to midazolam~Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered.~0.9% Saline: Administered intranasally prior to Midazolam administration."
35602|NCT02396537|E1|Reported Event|Intranasal Lidocaine|"Patient to receive 4% lidocaine intranasally prior to midazolam~Lidocaine: Administered intranasally prior to Midazolam administration.~Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered."
35603|NCT02396316|B3|Baseline|Total|Total of all reporting groups
35604|NCT02396316|B2|Baseline|Sham Injection Group|"Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met. Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) :~IOP higher than 21mmHg;~Incomplete regression of iris neovascularization and;~Aflibercept IVT deemed necessary by the investigator."
35605|NCT02396316|B1|Baseline|Aflibercept 2 mg Intravitreal (IVT) Injection Group|"Subjects received intravitreal (IVT) injection of 2 mg (0.05 milliliter [ml] * 40 milligram per milliliter [mg/ml]) aflibercept on Day 1. Then, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met. Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) :~IOP higher than 21mmHg;~Incomplete regression of iris neovascularization and;~Aflibercept IVT deemed necessary by the investigator."
35606|NCT02396316|P2|Participant Flow|Sham Injection Group|"Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met. Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) :~IOP higher than 21mmHg;~Incomplete regression of iris neovascularization and;~Aflibercept IVT deemed necessary by the investigator."
35607|NCT02396316|P1|Participant Flow|Aflibercept 2 mg Intravitreal (IVT) Injection Group|"Subjects received intravitreal (IVT) injection of 2 mg (0.05 milliliter [ml] * 40 milligram per milliliter [mg/ml]) aflibercept on Day 1. Then, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met. Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) :~IOP higher than 21mmHg;~Incomplete regression of iris neovascularization and;~Aflibercept IVT deemed necessary by the investigator."
35653|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
39988|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
35608|NCT02396316|O2|Outcome|Sham Injection Group|"Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met.~Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) :~IOP higher than 21mmHg;~Incomplete regression of iris neovascularization and;~Aflibercept IVT deemed necessary by the investigator."
35609|NCT02396316|O1|Outcome|Aflibercept 2 mg Intravitreal (IVT) Injection Group|"Subjects received intravitreal (IVT) injection of 2 mg (0.05 ml * 40 mg/ml) aflibercept on Day 1. Then, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met.~Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) :~IOP higher than 21mmHg;~Incomplete regression of iris neovascularization and;~Aflibercept IVT deemed necessary by the investigator."
35610|NCT02396316|O2|Outcome|Sham Injection Group|"Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met.~Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) :~IOP higher than 21mmHg;~Incomplete regression of iris neovascularization and;~Aflibercept IVT deemed necessary by the investigator."
35611|NCT02396316|O1|Outcome|Aflibercept 2 mg Intravitreal (IVT) Injection Group|"Subjects received intravitreal (IVT) injection of 2 mg (0.05 ml * 40 mg/ml) aflibercept on Day 1. Then, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met.~Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) :~IOP higher than 21mmHg;~Incomplete regression of iris neovascularization and;~Aflibercept IVT deemed necessary by the investigator."
35612|NCT02396316|E4|Reported Event|Sham Injection Group (Till Pre-dose at Week 1)|"Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met.~Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) :~IOP higher than 21mmHg;~Incomplete regression of iris neovascularization and;~Aflibercept IVT deemed necessary by the investigator. (AE time frame: from the first dose of study drug until pre-dose at Week 1)"
35613|NCT02396316|E3|Reported Event|Aflibercept 2 mg IVT Injection Group (Till Pre-dose at Week 1)|"Subjects received IVT injection of 2 mg (0.05 ml * 40 mg/ml) aflibercept on Day 1. Then, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met.~Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) :~IOP higher than 21mmHg;~Incomplete regression of iris neovascularization and;~Aflibercept IVT deemed necessary by the investigator. (AE time frame: from the first dose of study drug until pre-dose at Week 1)"
35614|NCT02396316|E2|Reported Event|Sham Injection Group|"Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met.~Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) :~IOP higher than 21mmHg;~Incomplete regression of iris neovascularization and;~Aflibercept IVT deemed necessary by the investigator. (AE time frame: from first dose of study drug until 30 days after the last dose of study drug)"
35615|NCT02396316|E1|Reported Event|Aflibercept 2 mg Intravitreal (IVT) Injection Group|"Subjects received intravitreal (IVT) injection of 2 mg (0.05 ml * 40 mg/ml) aflibercept on Day 1. Then, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met.~Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) :~IOP higher than 21mmHg;~Incomplete regression of iris neovascularization and;~Aflibercept IVT deemed necessary by the investigator. (AE time frame: from first dose of study drug until 30 days after the last dose of study drug)"
35616|NCT02396160|B3|Baseline|Total|Total of all reporting groups
35617|NCT02396160|B2|Baseline|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
35618|NCT02396160|B1|Baseline|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
35619|NCT02396160|P2|Participant Flow|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
35620|NCT02396160|P1|Participant Flow|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
35621|NCT02396160|O2|Outcome|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
35622|NCT02396160|O1|Outcome|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
35623|NCT02396160|O2|Outcome|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
35624|NCT02396160|O1|Outcome|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
35625|NCT02396160|O2|Outcome|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
35847|NCT02393950|P1|Participant Flow|Panel 1|Single oral doses ODM-106 Capsule B: 2, 10, 25, 50 mg , placebo
35628|NCT02396160|O1|Outcome|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
35629|NCT02396160|O2|Outcome|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
35630|NCT02396160|O1|Outcome|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
35631|NCT02396160|E2|Reported Event|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
35632|NCT02396160|E1|Reported Event|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
35633|NCT02396147|B3|Baseline|Total|Total of all reporting groups
35634|NCT02396147|B2|Baseline|Arm 2: T2-A + T4C-D + T4C-E|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was 10-day washout period between each dose.
35635|NCT02396147|B1|Baseline|Arm 1: T2-A + T4B-B + T4B-C|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was a 10-day washout period between each dose.
35636|NCT02396147|P2|Participant Flow|Arm 2: T2-A + T4C-D + T4C-E|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was 10-day washout period between each dose.
35637|NCT02396147|P1|Participant Flow|Arm 1: T2-A + T4B-B + T4B-C|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was a 10-day washout period between each dose.
35638|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35639|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35640|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35641|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35642|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35643|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35644|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35645|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35646|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35647|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35648|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35649|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35650|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35651|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35652|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35655|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35656|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35657|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35658|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35659|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35660|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35661|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35662|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35663|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35664|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35665|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35666|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35667|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35668|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35669|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35670|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35671|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35672|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35673|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35674|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35675|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35676|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35677|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35678|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35679|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35680|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35681|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35682|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35683|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35684|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35685|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35686|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35687|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35688|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35689|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35690|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35691|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35692|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35693|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35694|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35695|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35696|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35697|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35698|NCT02396147|E6|Reported Event|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35699|NCT02396147|E5|Reported Event|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35700|NCT02396147|E4|Reported Event|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35701|NCT02396147|E3|Reported Event|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35702|NCT02396147|E2|Reported Event|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35703|NCT02396147|E1|Reported Event|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
35704|NCT02395822|B1|Baseline|Preparative Regimen and SubQ rHuIL-15|"Preparative Regimen of Fludarabine and Cyclophosphamide~IL-15 Activation of Donor NK Cells:~IL-15 to Facilitate NK Cell Survival and Expansion~IL-15: Preparative Regimen:~Fludarabine 25 mg/m2 x 5 days start day -6 Cyclophosphamide 60 mg/kg x 2 days on day -5 and -4 (if < 4 months from prior transplant, omit day -4 dose)~IL-15 Activated Donor NK Cells:~The apheresis product (collected day -1) will be enriched for NK cells with the large-scale CliniMacs® device (Miltenyi) by depletion of CD3+ cells to remove T-lymphocytes and depletion of CD19+ cells to remove B-lymphocytes. The NK cell enriched product will be activated by overnight incubation with10 ng/ml IL-15 under GMP conditions and infused on day 0.~IL-15 to Facilitate NK Cell Survival and Expansion:~IL-15 at 2 mcg/kg subcutaneously (SC) beginning day +1, once a day for 5 days followed by a 2 day rest, and then once a day for 5 days for 10 doses total"
35705|NCT02395822|P1|Participant Flow|Preparative Regimen and SubQ rHuIL-15|"Preparative Regimen of Fludarabine and Cyclophosphamide~IL-15 Activation of Donor NK Cells:~IL-15 to Facilitate NK Cell Survival and Expansion~IL-15: Preparative Regimen:~Fludarabine 25 mg/m2 x 5 days start day -6 Cyclophosphamide 60 mg/kg x 2 days on day -5 and -4 (if < 4 months from prior transplant, omit day -4 dose)~IL-15 Activated Donor NK Cells:~The apheresis product (collected day -1) will be enriched for NK cells with the large-scale CliniMacs® device (Miltenyi) by depletion of CD3+ cells to remove T-lymphocytes and depletion of CD19+ cells to remove B-lymphocytes. The NK cell enriched product will be activated by overnight incubation with10 ng/ml IL-15 under GMP conditions and infused on day 0.~IL-15 to Facilitate NK Cell Survival and Expansion:~IL-15 at 2 mcg/kg subcutaneously (SC) beginning day +1, once a day for 5 days followed by a 2 day rest, and then once a day for 5 days for 10 doses total"
35717|NCT02395653|O1|Outcome|SSEC Fentanyl|Post-surgery, participants received fentanyl via the active IONSYS® SSEC fentanyl iontophoretic transdermal system that provided on-demand systemic delivery of 40 mcg fentanyl per dose for up to 24 hours, or a maximum of 80 doses, whichever came first, for up to 3 consecutive days (up to 72 hours).
35718|NCT02395653|E1|Reported Event|SSEC Fentanyl|Post-surgery, participants received fentanyl via the active IONSYS® SSEC fentanyl iontophoretic transdermal system that provided on-demand systemic delivery of 40 mcg fentanyl per dose for up to 24 hours, or a maximum of 80 doses, whichever came first, for up to 3 consecutive days (up to 72 hours).
35719|NCT02395536|B3|Baseline|Total|Total of all reporting groups
35706|NCT02395822|O1|Outcome|Preparative Regimen and SubQ rHuIL-15|"Preparative Regimen of Fludarabine and Cyclophosphamide~IL-15 Activation of Donor NK Cells:~IL-15 to Facilitate NK Cell Survival and Expansion~IL-15: Preparative Regimen:~Fludarabine 25 mg/m2 x 5 days start day -6 Cyclophosphamide 60 mg/kg x 2 days on day -5 and -4 (if < 4 months from prior transplant, omit day -4 dose)~IL-15 Activated Donor NK Cells:~The apheresis product (collected day -1) will be enriched for NK cells with the large-scale CliniMacs® device (Miltenyi) by depletion of CD3+ cells to remove T-lymphocytes and depletion of CD19+ cells to remove B-lymphocytes. The NK cell enriched product will be activated by overnight incubation with10 ng/ml IL-15 under GMP conditions and infused on day 0.~IL-15 to Facilitate NK Cell Survival and Expansion:~IL-15 at 2 mcg/kg subcutaneously (SC) beginning day +1, once a day for 5 days followed by a 2 day rest, and then once a day for 5 days for 10 doses total"
35707|NCT02395822|O1|Outcome|Preparative Regimen and SubQ rHuIL-15|"Preparative Regimen of Fludarabine and Cyclophosphamide~IL-15 Activation of Donor NK Cells:~IL-15 to Facilitate NK Cell Survival and Expansion~IL-15: Preparative Regimen:~Fludarabine 25 mg/m2 x 5 days start day -6 Cyclophosphamide 60 mg/kg x 2 days on day -5 and -4 (if < 4 months from prior transplant, omit day -4 dose)~IL-15 Activated Donor NK Cells:~The apheresis product (collected day -1) will be enriched for NK cells with the large-scale CliniMacs® device (Miltenyi) by depletion of CD3+ cells to remove T-lymphocytes and depletion of CD19+ cells to remove B-lymphocytes. The NK cell enriched product will be activated by overnight incubation with10 ng/ml IL-15 under GMP conditions and infused on day 0.~IL-15 to Facilitate NK Cell Survival and Expansion:~IL-15 at 2 mcg/kg subcutaneously (SC) beginning day +1, once a day for 5 days followed by a 2 day rest, and then once a day for 5 days for 10 doses total"
35708|NCT02395822|O1|Outcome|Preparative Regimen and SubQ rHuIL-15|"Preparative Regimen of Fludarabine and Cyclophosphamide~IL-15 Activation of Donor NK Cells:~IL-15 to Facilitate NK Cell Survival and Expansion~IL-15: Preparative Regimen:~Fludarabine 25 mg/m2 x 5 days start day -6 Cyclophosphamide 60 mg/kg x 2 days on day -5 and -4 (if < 4 months from prior transplant, omit day -4 dose)~IL-15 Activated Donor NK Cells:~The apheresis product (collected day -1) will be enriched for NK cells with the large-scale CliniMacs® device (Miltenyi) by depletion of CD3+ cells to remove T-lymphocytes and depletion of CD19+ cells to remove B-lymphocytes. The NK cell enriched product will be activated by overnight incubation with10 ng/ml IL-15 under GMP conditions and infused on day 0.~IL-15 to Facilitate NK Cell Survival and Expansion:~IL-15 at 2 mcg/kg subcutaneously (SC) beginning day +1, once a day for 5 days followed by a 2 day rest, and then once a day for 5 days for 10 doses total"
35709|NCT02395822|O1|Outcome|Preparative Regimen and SubQ rHuIL-15|"Preparative Regimen of Fludarabine and Cyclophosphamide~IL-15 Activation of Donor NK Cells:~IL-15 to Facilitate NK Cell Survival and Expansion~IL-15: Preparative Regimen:~Fludarabine 25 mg/m2 x 5 days start day -6 Cyclophosphamide 60 mg/kg x 2 days on day -5 and -4 (if < 4 months from prior transplant, omit day -4 dose)~IL-15 Activated Donor NK Cells:~The apheresis product (collected day -1) will be enriched for NK cells with the large-scale CliniMacs® device (Miltenyi) by depletion of CD3+ cells to remove T-lymphocytes and depletion of CD19+ cells to remove B-lymphocytes. The NK cell enriched product will be activated by overnight incubation with10 ng/ml IL-15 under GMP conditions and infused on day 0.~IL-15 to Facilitate NK Cell Survival and Expansion:~IL-15 at 2 mcg/kg subcutaneously (SC) beginning day +1, once a day for 5 days followed by a 2 day rest, and then once a day for 5 days for 10 doses total"
35710|NCT02395822|O1|Outcome|Preparative Regimen and SubQ rHuIL-15|"Preparative Regimen of Fludarabine and Cyclophosphamide~IL-15 Activation of Donor NK Cells:~IL-15 to Facilitate NK Cell Survival and Expansion~IL-15: Preparative Regimen:~Fludarabine 25 mg/m2 x 5 days start day -6 Cyclophosphamide 60 mg/kg x 2 days on day -5 and -4 (if < 4 months from prior transplant, omit day -4 dose)~IL-15 Activated Donor NK Cells:~The apheresis product (collected day -1) will be enriched for NK cells with the large-scale CliniMacs® device (Miltenyi) by depletion of CD3+ cells to remove T-lymphocytes and depletion of CD19+ cells to remove B-lymphocytes. The NK cell enriched product will be activated by overnight incubation with10 ng/ml IL-15 under GMP conditions and infused on day 0.~IL-15 to Facilitate NK Cell Survival and Expansion:~IL-15 at 2 mcg/kg subcutaneously (SC) beginning day +1, once a day for 5 days followed by a 2 day rest, and then once a day for 5 days for 10 doses total"
35711|NCT02395822|E1|Reported Event|Preparative Regimen and SubQ rHuIL-15|"Preparative Regimen of Fludarabine and Cyclophosphamide~IL-15 Activation of Donor NK Cells:~IL-15 to Facilitate NK Cell Survival and Expansion~IL-15: Preparative Regimen:~Fludarabine 25 mg/m2 x 5 days start day -6 Cyclophosphamide 60 mg/kg x 2 days on day -5 and -4 (if < 4 months from prior transplant, omit day -4 dose)~IL-15 Activated Donor NK Cells:~The apheresis product (collected day -1) will be enriched for NK cells with the large-scale CliniMacs® device (Miltenyi) by depletion of CD3+ cells to remove T-lymphocytes and depletion of CD19+ cells to remove B-lymphocytes. The NK cell enriched product will be activated by overnight incubation with10 ng/ml IL-15 under GMP conditions and infused on day 0.~IL-15 to Facilitate NK Cell Survival and Expansion:~IL-15 at 2 mcg/kg subcutaneously (SC) beginning day +1, once a day for 5 days followed by a 2 day rest, and then once a day for 5 days for 10 doses total"
35712|NCT02395653|B1|Baseline|SSEC Fentanyl|Post-surgery, participants received fentanyl via the active IONSYS® SSEC fentanyl iontophoretic transdermal system that provided on-demand systemic delivery of 40 mcg fentanyl per dose for up to 24 hours, or a maximum of 80 doses, whichever came first, for up to 3 consecutive days (up to 72 hours).
35713|NCT02395653|P1|Participant Flow|SSEC Fentanyl|Post-surgery, participants received fentanyl via the active IONSYS® SSEC fentanyl iontophoretic transdermal system that provided on-demand systemic delivery of 40 mcg fentanyl per dose for up to 24 hours, or a maximum of 80 doses, whichever came first, for up to 3 consecutive days (up to 72 hours).
35714|NCT02395653|O1|Outcome|SSEC Fentanyl|Post-surgery, participants received fentanyl via the active IONSYS® SSEC fentanyl iontophoretic transdermal system that provided on-demand systemic delivery of 40 mcg fentanyl per dose for up to 24 hours, or a maximum of 80 doses, whichever came first, for up to 3 consecutive days (up to 72 hours).
35715|NCT02395653|O1|Outcome|SSEC Fentanyl|Post-surgery, participants received fentanyl via the active IONSYS® SSEC fentanyl iontophoretic transdermal system that provided on-demand systemic delivery of 40 mcg fentanyl per dose for up to 24 hours, or a maximum of 80 doses, whichever came first, for up to 3 consecutive days (up to 72 hours).
35716|NCT02395653|O1|Outcome|SSEC Fentanyl|Post-surgery, participants received fentanyl via the active IONSYS® SSEC fentanyl iontophoretic transdermal system that provided on-demand systemic delivery of 40 mcg fentanyl per dose for up to 24 hours, or a maximum of 80 doses, whichever came first, for up to 3 consecutive days (up to 72 hours).
35848|NCT02393950|O9|Outcome|Placebo|2 placebo subjects per Arm with matched number of placebo capsules.
35720|NCT02395536|B2|Baseline|Traditional Hospital Setting|"Reveal LINQ insertions will be performed in IN-a traditional setting~Insertion of Reveal LINQ device in office or traditional hospital setting: The insterions will be performed in a Physician office setting or in Traditional Hospital Setting as per the arm the patient is randomized in."
35721|NCT02395536|B1|Baseline|In Office Outside Walls of Hospital|"Reveal LINQ insertions will be performed in office setting.~Insertion of Reveal LINQ device in office or traditional hospital setting: The insterions will be performed in a Physician office setting or in Traditional Hospital Setting as per the arm the patient is randomized in."
35722|NCT02395536|P2|Participant Flow|Traditional Hospital Setting|"Reveal LINQ insertions will be performed in IN-a traditional setting~Insertion of Reveal LINQ device in office or traditional hospital setting: The insterions will be performed in a Physician office setting or in Traditional Hospital Setting as per the arm the patient is randomized in."
35723|NCT02395536|P1|Participant Flow|In Office Outside Walls of Hospital|"Reveal LINQ insertions will be performed in office setting.~Insertion of Reveal LINQ device in office or traditional hospital setting: The insterions will be performed in a Physician office setting or in Traditional Hospital Setting as per the arm the patient is randomized in."
35724|NCT02395536|O2|Outcome|Traditional Hospital Setting|"Reveal LINQ insertions will be performed in IN-a traditional setting~Insertion of Reveal LINQ device in office or traditional hospital setting: The insterions will be performed in a Physician office setting or in Traditional Hospital Setting as per the arm the patient is randomized in."
35725|NCT02395536|O1|Outcome|In Office Outside Walls of Hospital|"Reveal LINQ insertions will be performed in office setting.~Insertion of Reveal LINQ device in office or traditional hospital setting: The insterions will be performed in a Physician office setting or in Traditional Hospital Setting as per the arm the patient is randomized in."
35726|NCT02395536|E2|Reported Event|Traditional Hospital Setting|"Reveal LINQ insertions will be performed in IN-a traditional setting~Insertion of Reveal LINQ device in office or traditional hospital setting: The insterions will be performed in a Physician office setting or in Traditional Hospital Setting as per the arm the patient is randomized in."
35727|NCT02395536|E1|Reported Event|In Office Outside Walls of Hospital|"Reveal LINQ insertions will be performed in office setting.~Insertion of Reveal LINQ device in office or traditional hospital setting: The insterions will be performed in a Physician office setting or in Traditional Hospital Setting as per the arm the patient is randomized in."
35728|NCT02395302|B1|Baseline|Dual Action Pneumatic Compression|"Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.~Dual Action Pneumatic Compression: Wear in sustained mode for 14 hours and pneumatic compression mode for 3 hours during the 4 week treatment period."
35729|NCT02395302|P1|Participant Flow|Dual Action Pneumatic Compression|Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an alternating current (AC) outlet. Subjects that received the dual action pneumatic compression device were instructed to use the device in sustained mode for fourteen hours per day and in intermittent mode for three hours per day during the four week treatment period.
35730|NCT02395302|O1|Outcome|Dual Action Pneumatic Compression|Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.
35731|NCT02395302|E1|Reported Event|Dual Action Pneumatic Compression|Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.
35732|NCT02395185|B1|Baseline|All Participants|"Bottle Administration: 2 oz of sucrose, water, or milk/formula given in a bottle during the casting process~Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized."
35733|NCT02395185|P1|Participant Flow|All Participants|33 Participants were randomized to one of 18 sequences of milk, water, or formula for an average of 6 casting visits.
35734|NCT02395185|O3|Outcome|Sucrose|"Bottle Administration: 2 oz sucrose solution given in a bottle during the casting process~Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized."
35735|NCT02395185|O2|Outcome|Water|"Bottle Administration: 2 oz water given in a bottle during the casting process~Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized."
35736|NCT02395185|O1|Outcome|Milk|"Bottle Administration: 2 oz milk or formula given in a bottle during the casting process~Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized."
35737|NCT02395185|O3|Outcome|Sucrose|"Bottle Administration: 2 oz sucrose solution given in a bottle during the casting process~Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized."
35738|NCT02395185|O2|Outcome|Water|"Bottle Administration: 2 oz water given in a bottle during the casting process~Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized."
35739|NCT02395185|O1|Outcome|Milk|"Bottle Administration: 2 oz milk or formula given in a bottle during the casting process~Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized."
35740|NCT02395185|O3|Outcome|Sucrose|"Bottle Administration: 2 oz sucrose solution given in a bottle during the casting process~Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized."
35741|NCT02395185|O2|Outcome|Water|"Bottle Administration: 2 oz water given in a bottle during the casting process~Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized."
35742|NCT02395185|O1|Outcome|Milk|"Bottle Administration: 2 oz milk or formula given in a bottle during the casting process~Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized."
35743|NCT02395185|E3|Reported Event|Water|"Bottle Administration: 2 oz water given in a bottle during the casting process~Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized."
35744|NCT02395185|E2|Reported Event|Milk or Formula|"Bottle Administration: 2 oz milk or formula given in a bottle during the casting process~Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized."
35745|NCT02395185|E1|Reported Event|Sucrose|"Bottle Administration: 2 oz sucrose solution given in a bottle during the casting process~Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized."
35746|NCT02395055|B3|Baseline|Total|Total of all reporting groups
35747|NCT02395055|B2|Baseline|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
35748|NCT02395055|B1|Baseline|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
35749|NCT02395055|P2|Participant Flow|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
35750|NCT02395055|P1|Participant Flow|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
35751|NCT02395055|O2|Outcome|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
35752|NCT02395055|O1|Outcome|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
35753|NCT02395055|O2|Outcome|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
35754|NCT02395055|O1|Outcome|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
35755|NCT02395055|O2|Outcome|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
35756|NCT02395055|O1|Outcome|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
35757|NCT02395055|E2|Reported Event|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
35758|NCT02395055|E1|Reported Event|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
35759|NCT02394925|B1|Baseline|Dispensed Subjects|All subjects in that were dispensed the study lens.
35760|NCT02394925|P1|Participant Flow|Etafilcon -PVP (Multi-focal)|All subjects in the study wore the test lens etafilcon- PVP (Multi-focal) throughout the entire duration of the study.
35761|NCT02394925|O1|Outcome|Etafilcon -PVP (Multi-focal)|All subjects in the study wore the test lens etafilcon- PVP (Multi-focal) throughout the entire duration of the study.
35762|NCT02394925|E1|Reported Event|Etafilcon -PVP (Multi-focal)|All subjects in the study wore the test lens etafilcon- PVP (Multi-focal) throughout the entire duration of the study.
35763|NCT02394808|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens throughout the duration of the study.
35764|NCT02394808|P2|Participant Flow|Lotrafilcon B/Senofilcon A|Subjects randomized to this sequence first wore the lotrafilcon B lens and then wore the senofilcon A lens.
35765|NCT02394808|P1|Participant Flow|Senofilcon A/ Lotrafilcon B|Subjects randomized to this sequence first wore the senofilcon A lens and then wore the lotrafilcon B lens.
35766|NCT02394808|O2|Outcome|Lotrafilcon B|Subjects that wore the lotrafilcon B lens in either the first or second period of the study.
35767|NCT02394808|O1|Outcome|Senofilcon A|Subjects that wore the senofilcon A lens in either the first or second period of the study.
35768|NCT02394808|O2|Outcome|Lotrafilcon B|Subjects that wore the lotrafilcon B lens in either the first or second period of the study.
35769|NCT02394808|O1|Outcome|Senofilcon A|Subjects that wore the senofilcon A lens in either the first or second period of the study.
35770|NCT02394808|E2|Reported Event|Lotrafilcon B|Subjects that wore the lotrafilcon B lens in either the first or second period of the study.
35771|NCT02394808|E1|Reported Event|Senofilcon A|Subjects that wore the senofilcon A lens in either the first or second period of the study.
35772|NCT02394756|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least 1 study lens.
35773|NCT02394756|P6|Participant Flow|Comfilcon A/Lotrafilcon B/Senofilcon A|Subjects randomized to this sequence wore the comfilcon A lens in the first period, the lotrafilcon B lens in the second period and the senofilcon A lens in the third period.
35774|NCT02394756|P5|Participant Flow|Comfilcon A/Senofilcon A/ Lotrafilcon B|Subjects randomized to this sequence wore the comfilcon A lens in the first period, the senofilcon A lens in the second period and the lotrafilcon B lens in the third period.
35775|NCT02394756|P4|Participant Flow|Lotrafilcon B/Senofilcon A/Comfilcon A|Subjects randomized to this sequence wore the lotrafilcon B lens in the first period, the senofilcon A lens in the second period and the comfilcon A lens in the third period.
35776|NCT02394756|P3|Participant Flow|Lotrafilcon B/Comfilcon A/Senofilcon A|Subjects randomized to this sequence wore the lotrafilcon B lens in the first period, the comfilcon A lens in the second period and the senofilcon A lens in the third period.
35777|NCT02394756|P2|Participant Flow|Senfilcon A/Comfilcon A/Lotrafilcon B|Subjects randomized to this sequence wore the senofilcon A lens in the first period, the comfilcon A lens in the second period and the lotrafilcon B lens in the third period.
35778|NCT02394756|P1|Participant Flow|Senofilcon A/Lotrafilcon B/Comfilcon A|Subjects randomized to this sequence wore the senofilcon A lens in the first period, the lotrafilcon B lens in the second period and the comfilcon A lens in the third period.
35779|NCT02394756|O3|Outcome|Comfilcon A|Subjects wore the comfilcon A lens in any of the three periods during the study.
35780|NCT02394756|O2|Outcome|Lotrafilcon B|Subjects wore the lotrafilcon B lens in any of the three periods during the study.
35781|NCT02394756|O1|Outcome|Senofilcon A|Subjects wore the senofilcon A lens in any of the three periods during the study.
35782|NCT02394756|O3|Outcome|Comfilcon A|Subjects wore the comfilcon A lens in any of the three periods during the study.
35783|NCT02394756|O2|Outcome|Lotrafilcon B|Subjects wore the lotrafilcon B lens in any of the three periods during the study.
39989|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
35789|NCT02394665|B3|Baseline|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
35790|NCT02394665|B2|Baseline|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
35791|NCT02394665|B1|Baseline|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
35792|NCT02394665|P3|Participant Flow|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
35793|NCT02394665|P2|Participant Flow|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
35794|NCT02394665|P1|Participant Flow|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
35795|NCT02394665|O3|Outcome|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
35796|NCT02394665|O2|Outcome|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
35797|NCT02394665|O1|Outcome|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
35798|NCT02394665|O3|Outcome|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
35799|NCT02394665|O2|Outcome|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
35800|NCT02394665|O1|Outcome|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
35801|NCT02394665|O3|Outcome|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
35802|NCT02394665|O2|Outcome|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
35803|NCT02394665|O1|Outcome|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
35804|NCT02394665|O3|Outcome|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
35805|NCT02394665|O2|Outcome|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
35806|NCT02394665|O1|Outcome|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
35849|NCT02393950|O8|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10mg ODM-106 Capsule A
35807|NCT02394665|O3|Outcome|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
35808|NCT02394665|O2|Outcome|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
35809|NCT02394665|O1|Outcome|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
35810|NCT02394665|E3|Reported Event|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
35811|NCT02394665|E2|Reported Event|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
35812|NCT02394665|E1|Reported Event|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
35813|NCT02394600|B3|Baseline|Total|Total of all reporting groups
35814|NCT02394600|B2|Baseline|Placebo|4 months of once per day matching placebo sublingual tablet
35815|NCT02394600|B1|Baseline|Grastek|4 months of once per day Grastek sublingual immunotherapy
35816|NCT02394600|P2|Participant Flow|Placebo|4 months of once per day matching placebo sublingual tablet
35817|NCT02394600|P1|Participant Flow|Grastek|4 months of once per day Grastek sublingual immunotherapy
35818|NCT02394600|O2|Outcome|Placebo|4 months of once per matching placebo sublingual tablet
35819|NCT02394600|O1|Outcome|Grastek|4 months of once per day Grastek sublingual immunotherapy
35820|NCT02394600|O2|Outcome|Placebo|4 months of once per matching placebo sublingual tablet
35821|NCT02394600|O1|Outcome|Grastek|4 months of once per day Grastek sublingual immunotherapy
35822|NCT02394600|E2|Reported Event|Placebo|4 months of once per day matching placebo sublingual tablet
35823|NCT02394600|E1|Reported Event|Grastek®|4 months of once per day Grastek sublingual immunotherapy
35824|NCT02394457|B3|Baseline|Total|Total of all reporting groups
35825|NCT02394457|B2|Baseline|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
35826|NCT02394457|B1|Baseline|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
35827|NCT02394457|P2|Participant Flow|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
35828|NCT02394457|P1|Participant Flow|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
35829|NCT02394457|O2|Outcome|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
35830|NCT02394457|O1|Outcome|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
35831|NCT02394457|O2|Outcome|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
35832|NCT02394457|O1|Outcome|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
35833|NCT02394457|O2|Outcome|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
35834|NCT02394457|O1|Outcome|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
35835|NCT02394457|O2|Outcome|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
35836|NCT02394457|O1|Outcome|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
35837|NCT02394457|O2|Outcome|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
35838|NCT02394457|O1|Outcome|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
35839|NCT02394457|O2|Outcome|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
35840|NCT02394457|O1|Outcome|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
35841|NCT02394457|E2|Reported Event|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
35850|NCT02393950|O7|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10mg ODM-106 Capsule B
35863|NCT02393950|O3|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10 mg 1 x 5 mg ODM-106 Capsule B.
35864|NCT02393950|O2|Outcome|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B.
35865|NCT02393950|O1|Outcome|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B.
35866|NCT02393950|O9|Outcome|Placebo|2 placebo subjects per Arm with matched number of placebo capsules.
35867|NCT02393950|O8|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10 mg ODM-106 Capsule A.
35868|NCT02393950|O7|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10 mg ODM-106 Capsule B
35869|NCT02393950|O6|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10 mg ODM-106 Capsule B.
35870|NCT02393950|O5|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100 mg ODM-106 Capsule B
35871|NCT02393950|O4|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10 mg ODM-106 Capsule B
35872|NCT02393950|O3|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10 mg 1 x 5mg ODM-106 Capsule B
35873|NCT02393950|O2|Outcome|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B
35874|NCT02393950|O1|Outcome|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B
35875|NCT02393950|O9|Outcome|Placebo|2 placebo subjects per Arm with matched number of placebo capsules.
35876|NCT02393950|O8|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10 mg ODM-106 Capsule A
35877|NCT02393950|O7|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10 mg ODM-106 Capsule B
35878|NCT02393950|O6|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10 mg ODM-106 Capsule B
35879|NCT02393950|O5|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100 mg ODM-106 Capsule B
35880|NCT02393950|O4|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10 mg ODM-106 Capsule B
35881|NCT02393950|O3|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10 mg and 1 x 5 mg ODM-106 Capsule B
35882|NCT02393950|O2|Outcome|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B
35883|NCT02393950|O1|Outcome|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B
35884|NCT02393950|O9|Outcome|Placebo|2 placebo subjects per Arm with matched number of placebo capsules.
35885|NCT02393950|O8|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10 mg ODM-106 Capsule A
35886|NCT02393950|O7|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10 mg ODM-106 Capsule B
35887|NCT02393950|O6|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10 mg ODM-106 Capsule B
35888|NCT02393950|O5|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100 mg ODM-106 Capsule B
35889|NCT02393950|O4|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10 mg ODM-106 Capsule B
35890|NCT02393950|O3|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10 mg and 1 x 5 mg ODM-106 Capsule B
35891|NCT02393950|O2|Outcome|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B
35892|NCT02393950|O1|Outcome|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B
35893|NCT02393950|O9|Outcome|Placebo|2 placebo subjects per Arm with matched number of placebo capsules.
35894|NCT02393950|O8|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10mg ODM-106 Capsule A
35895|NCT02393950|O7|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10mg ODM-106 Capsule B
35896|NCT02393950|O6|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10mg ODM-106 Capsule B
35897|NCT02393950|O5|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100mg ODM-106 Capsule B
35898|NCT02393950|O4|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10mg ODM-106 Capsule B
35899|NCT02393950|O3|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10mg 1 x 5 mg ODM-106 Capsule B
35900|NCT02393950|O2|Outcome|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B
35901|NCT02393950|O1|Outcome|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B
35902|NCT02393950|E9|Reported Event|Placebo|2 placebo subjects per Arm with matched number of placebo capsules
35903|NCT02393950|E8|Reported Event|ODM-106 Capsule A 100mg|Single oral dose 10 x 10 mg ODM-106 Capsule A
35904|NCT02393950|E7|Reported Event|ODM-106 Capsule B 200mg|Single oral dose 20 x 10 mg ODM-106 Capsule B
35905|NCT02393950|E6|Reported Event|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10 mg ODM-106 Capsule B
35906|NCT02393950|E5|Reported Event|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100 mg ODM-106 Capsule B
35907|NCT02393950|E4|Reported Event|ODM-106 Capsule B 50mg|Single oral dose 5 x 10 mg ODM-106 Capsule B
35908|NCT02393950|E3|Reported Event|ODM-106 Capsule B 25mg|Single oral dose 2 x 10 mg 1 x 5 mg ODM-106 Capsule B
35909|NCT02393950|E2|Reported Event|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B
35910|NCT02393950|E1|Reported Event|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B
35911|NCT02393677|B3|Baseline|Total|Total of all reporting groups
35912|NCT02393677|B2|Baseline|Ropivacaine With Dexmedetomidine|"combination of amide local anaesthetic and alpha2 agonist~Ropivacaine with Dexmedetomidine: Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus"
35913|NCT02393677|B1|Baseline|Ropivacaine|"amide local anesthetic~Ropivacaine: Ropivacaine 0.5% 30 ml was used to block brachial plexus"
35914|NCT02393677|P2|Participant Flow|Ropivacaine With Dexmedetomidine|"combination of amide local anaesthetic and alpha2 agonist~Ropivacaine with Dexmedetomidine: Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus"
35915|NCT02393677|P1|Participant Flow|Ropivacaine|"amide local anesthetic~Ropivacaine: Ropivacaine 0.5% 30 ml was used to block brachial plexus"
35916|NCT02393677|O2|Outcome|Ropivacaine With Dexmedetomidine|"combination of amide local anaesthetic and alpha2 agonist~Ropivacaine with Dexmedetomidine: Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus"
35917|NCT02393677|O1|Outcome|Ropivacaine|"amide local anesthetic~Ropivacaine: Ropivacaine 0.5% 30 ml was used to block brachial plexus"
35918|NCT02393677|E2|Reported Event|Ropivacaine With Dexmedetomidine|"combination of amide local anaesthetic and alpha2 agonist~Ropivacaine with Dexmedetomidine: Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus"
35919|NCT02393677|E1|Reported Event|Ropivacaine|"amide local anesthetic~Ropivacaine: Ropivacaine 0.5% 30 ml was used to block brachial plexus"
35920|NCT02393547|B1|Baseline|Varenicline + Lorcaserin|"Open label all subjects receive both Varenicline and Lorcaserin~Varenicline: All subjects receive Varenicline~Lorcaserin: All subjects receive Lorcaserin"
35921|NCT02393547|P1|Participant Flow|Varenicline + Lorcaserin|"Open label all subjects receive both Varenicline and Lorcaserin~Varenicline: All subjects receive Varenicline~Lorcaserin: All subjects receive Lorcaserin"
35922|NCT02393547|O1|Outcome|Varenicline + Lorcaserin|"Open label all subjects receive both Varenicline and Lorcaserin~Varenicline: All subjects receive Varenicline~Lorcaserin: All subjects receive Lorcaserin"
35923|NCT02393547|O1|Outcome|Varenicline + Lorcaserin|"Open label all subjects receive both Varenicline and Lorcaserin~Varenicline: All subjects receive Varenicline~Lorcaserin: All subjects receive Lorcaserin"
35924|NCT02393547|O1|Outcome|Varenicline + Lorcaserin|"Open label all subjects receive both Varenicline and Lorcaserin~Varenicline: All subjects receive Varenicline~Lorcaserin: All subjects receive Lorcaserin"
35925|NCT02393547|O1|Outcome|Varenicline + Lorcaserin|"Open label all subjects receive both Varenicline and Lorcaserin~Varenicline: All subjects receive Varenicline~Lorcaserin: All subjects receive Lorcaserin"
35926|NCT02393547|E1|Reported Event|Varenicline + Lorcaserin|"Open label all subjects receive both Varenicline and Lorcaserin~Varenicline: All subjects receive Varenicline~Lorcaserin: All subjects receive Lorcaserin"
35927|NCT02393209|B3|Baseline|Total|Total of all reporting groups
35928|NCT02393209|B2|Baseline|Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2|TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).
35929|NCT02393209|B1|Baseline|Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2|TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
35930|NCT02393209|P4|Participant Flow|Phase 2 - Docetaxel 75 mg/m^2|Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.
35931|NCT02393209|P3|Participant Flow|Phase 2 - TAK-117 + Docetaxel 36 mg/m^2|TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
35932|NCT02393209|P2|Participant Flow|Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2|TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).
35933|NCT02393209|P1|Participant Flow|Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2|TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
35934|NCT02393209|O2|Outcome|Phase 2 - Docetaxel 75 mg/m^2|Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.
35935|NCT02393209|O1|Outcome|Phase 2 - TAK-117 + Docetaxel 36 mg/m^2|TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
35936|NCT02393209|O2|Outcome|Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2|TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).
35937|NCT02393209|O1|Outcome|Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2|TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
35938|NCT02393209|O2|Outcome|Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2|TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).
35939|NCT02393209|O1|Outcome|Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2|TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
35940|NCT02393209|O2|Outcome|Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2|TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).
35941|NCT02393209|O1|Outcome|Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2|TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
35942|NCT02393209|O2|Outcome|Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2|TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).
35943|NCT02393209|O1|Outcome|Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2|TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
35944|NCT02393209|O2|Outcome|Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2|TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).
35945|NCT02393209|O1|Outcome|Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2|TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
35946|NCT02393209|O2|Outcome|Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2|TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).
39990|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
35947|NCT02393209|O1|Outcome|Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2|TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
35948|NCT02393209|O2|Outcome|Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2|TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).
35949|NCT02393209|O1|Outcome|Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2|TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
35950|NCT02393209|O2|Outcome|Phase 2 - Docetaxel 75 mg/m^2|Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.
35951|NCT02393209|O1|Outcome|Phase 2 - TAK-117 + Docetaxel 36 mg/m^2|TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
35952|NCT02393209|O2|Outcome|Phase 2 - Docetaxel 75 mg/m^2|Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.
35953|NCT02393209|O1|Outcome|Phase 2 - TAK-117 + Docetaxel 36 mg/m^2|TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
35954|NCT02393209|O2|Outcome|Phase 2 - Docetaxel 75 mg/m^2|Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.
35955|NCT02393209|O1|Outcome|Phase 2 - TAK-117 + Docetaxel 36 mg/m^2|TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
35956|NCT02393209|O2|Outcome|Phase 2 - Docetaxel 75 mg/m^2|Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.
35957|NCT02393209|O1|Outcome|Phase 2 - TAK-117 + Docetaxel 36 mg/m^2|TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
35958|NCT02393209|O2|Outcome|Phase 2 - Docetaxel 75 mg/m^2|Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.
35959|NCT02393209|O1|Outcome|Phase 2 - TAK-117 + Docetaxel 36 mg/m^2|TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
35960|NCT02393209|O2|Outcome|Phase 2 - Docetaxel 75 mg/m^2|Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.
35961|NCT02393209|O1|Outcome|Phase 2 - TAK-117 + Docetaxel 36 mg/m^2|TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
35962|NCT02393209|O2|Outcome|Phase 2 - Docetaxel 75 mg/m^2|Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.
35963|NCT02393209|O1|Outcome|Phase 2 - TAK-117 + Docetaxel 36 mg/m^2|TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
35964|NCT02393209|O2|Outcome|Phase 2 - Docetaxel 75 mg/m^2|Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.
35965|NCT02393209|O1|Outcome|Phase 2 - TAK-117 + Docetaxel 36 mg/m^2|TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
35966|NCT02393209|O2|Outcome|Phase 2 - Docetaxel 75 mg/m^2|Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.
35967|NCT02393209|O1|Outcome|Phase 2 - TAK-117 + Docetaxel 36 mg/m^2|TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
35968|NCT02393209|O2|Outcome|Phase 2 - Docetaxel 75 mg/m^2|Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.
35969|NCT02393209|O1|Outcome|Phase 2 - TAK-117 + Docetaxel 36 mg/m^2|TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
35970|NCT02393209|O2|Outcome|Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2|TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).
35971|NCT02393209|O1|Outcome|Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2|TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
35972|NCT02393209|O2|Outcome|Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2|TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).
35973|NCT02393209|O1|Outcome|Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2|TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
35974|NCT02393209|O2|Outcome|Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2|TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).
36158|NCT02391116|O2|Outcome|CD79b Wild-type|Included all CD79b wild-type patients classified at baseline depending on biomarker value.
35975|NCT02393209|O1|Outcome|Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2|TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
35976|NCT02393209|O2|Outcome|Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2|TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).
35977|NCT02393209|O1|Outcome|Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2|TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
35978|NCT02393209|O2|Outcome|Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2|TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).
35979|NCT02393209|O1|Outcome|Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2|TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
35980|NCT02393209|O2|Outcome|Phase 2 - Docetaxel 75 mg/m^2|Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.
35981|NCT02393209|O1|Outcome|Phase 2 - TAK-117 + Docetaxel 36 mg/m^2|TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
35982|NCT02393209|O1|Outcome|TAK-117 + Docetaxel|TAK-117 200 mg or 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
35983|NCT02393209|O1|Outcome|TAK-117 + Docetaxel|TAK-117 200 mg or 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
35984|NCT02393209|O2|Outcome|Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2|TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).
35985|NCT02393209|O1|Outcome|Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2|TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
35986|NCT02393209|E2|Reported Event|Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2|TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).
35987|NCT02393209|E1|Reported Event|Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2|TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
35988|NCT02392806|B3|Baseline|Total|Total of all reporting groups
35989|NCT02392806|B2|Baseline|Bubble CPAP - B&B Bubbler, B&B Medical Technologies|"Infants randomized to the B&B Bubbler device will be extubated to B&B Bubbler Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the BabiPlus device~Bubble CPAP- B&B Bubbler, B&B Medical devices: Infant will be randomized to BabiPlus verses B&B Bubbler at time of extubation"
35990|NCT02392806|B1|Baseline|Bubble CPAP- BabiPlus, Respiralogics|"Infants randomized to the BabiPlus device will be extubated to BabiPlus Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the B&B Bubbler device~Bubble CPAP- BabiPlus, Respiralogics: Infant will be randomized to BabiPlus verses B&B Bubbler at time of extubation"
35991|NCT02392806|P2|Participant Flow|Bubble CPAP - B&B Bubbler, B&B Medical Technologies|"Infants randomized to the B&B Bubbler device will be extubated to B&B Bubbler Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the BabiPlus device~Bubble CPAP- B&B Bubbler, B&B Medical devices: Infant will be randomized to BabiPlus verses B&B Bubbler at time of extubation"
35992|NCT02392806|P1|Participant Flow|Bubble CPAP- BabiPlus, Respiralogics|"Infants randomized to the BabiPlus device will be extubated to BabiPlus Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the B&B Bubbler device~Bubble CPAP- BabiPlus, Respiralogics: Infant will be randomized to BabiPlus verses B&B Bubbler at time of extubation"
35993|NCT02392806|O2|Outcome|Bubble CPAP - B&B Bubbler, B&B Medical Technologies|"Infants randomized to the B&B Bubbler device will be extubated to B&B Bubbler Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the BabiPlus device~Bubble CPAP- B&B Bubbler, B&B Medical devices: Infant will be randomized to BabiPlus verses B&B Bubbler at time of extubation"
35994|NCT02392806|O1|Outcome|Bubble CPAP- BabiPlus, Respiralogics|"Infants randomized to the BabiPlus device will be extubated to BabiPlus Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the B&B Bubbler device~Bubble CPAP- BabiPlus, Respiralogics: Infant will be randomized to BabiPlus verses B&B Bubbler at time of extubation"
35995|NCT02392806|O2|Outcome|Bubble CPAP - B&B Bubbler, B&B Medical Technologies|"Infants randomized to the B&B Bubbler device will be extubated to B&B Bubbler Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the BabiPlus device~Bubble CPAP- B&B Bubbler, B&B Medical devices: Infant will be randomized to BabiPlus verses B&B Bubbler at time of extubation"
35996|NCT02392806|O1|Outcome|Bubble CPAP- BabiPlus, Respiralogics|"Infants randomized to the BabiPlus device will be extubated to BabiPlus Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the B&B Bubbler device~Bubble CPAP- BabiPlus, Respiralogics: Infant will be randomized to BabiPlus verses B&B Bubbler at time of extubation"
35997|NCT02392806|E2|Reported Event|Bubble CPAP - B&B Bubbler, B&B Medical Technologies|"Infants randomized to the B&B Bubbler device will be extubated to B&B Bubbler Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the BabiPlus device~Bubble CPAP- B&B Bubbler, B&B Medical devices: Infant will be randomized to BabiPlus verses B&B Bubbler at time of extubation"
39991|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
35998|NCT02392806|E1|Reported Event|Bubble CPAP- BabiPlus, Respiralogics|"Infants randomized to the BabiPlus device will be extubated to BabiPlus Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the B&B Bubbler device~Bubble CPAP- BabiPlus, Respiralogics: Infant will be randomized to BabiPlus verses B&B Bubbler at time of extubation"
35999|NCT02392767|B3|Baseline|Total|Total of all reporting groups
36000|NCT02392767|B2|Baseline|First Placebo, Then Verum|2 times a day 2 placebo tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 verum tablets for 4 weeks.
36001|NCT02392767|B1|Baseline|First Verum, Then Placebo|2 times a day 2 verum tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 placebo tablets for 4 weeks.
36002|NCT02392767|P2|Participant Flow|First Placebo, Then Verum|2 times a day 2 placebo tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 verum tablets for 4 weeks.
36003|NCT02392767|P1|Participant Flow|First Verum, Then Placebo|2 times a day 2 verum tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 placebo tablets for 4 weeks.
36004|NCT02392767|O2|Outcome|Placebo|"2 times 2 tablets a day for 4 weeks~Placebo: corn starch"
36005|NCT02392767|O1|Outcome|Verum|"2 times 2 tablets a day for 4 weeks.~Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
36006|NCT02392767|O2|Outcome|Placebo|"2 times 2 tablets a day for 4 weeks.~Placebo: corn starch"
36007|NCT02392767|O1|Outcome|Verum|"2 times 2 tablets a day for 4 weeks.~Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
36008|NCT02392767|O2|Outcome|Placebo|"2 times 2 tablets a day for 4 weeks.~Placebo: corn starch"
36009|NCT02392767|O1|Outcome|Verum|"2 times 2 tablets a day for 4 weeks.~Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
36010|NCT02392767|O2|Outcome|Placebo|2 times 2 tablets a day for 4 weeks. Placebo: corn starch
36011|NCT02392767|O1|Outcome|Verum|"2 times 2 tablets a day for 4 weeks.~Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
36012|NCT02392767|O2|Outcome|Placebo|"2 times 2 tablets a day for 4 weeks~Placebo: corn starch"
36013|NCT02392767|O1|Outcome|Verum|"2 times 2 tablets a day for 4 weeks.~Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
36014|NCT02392767|O2|Outcome|Placebo|"2 times 2 tablets a day for 4 weeks.~Placebo: corn starch"
36015|NCT02392767|O1|Outcome|Verum|"2 times 2 tablets a day for 4 weeks.~Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
36016|NCT02392767|E2|Reported Event|Placebo|"2 times 2 tablets a day for 4 weeks.~Placebo: corn starch"
36017|NCT02392767|E1|Reported Event|Verum|"2 times 2 tablets a day for 4 weeks.~Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
36018|NCT02392624|B4|Baseline|Total|Total of all reporting groups
36019|NCT02392624|B3|Baseline|Placebo (Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
36020|NCT02392624|B2|Baseline|Omalizumab (Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with omalizumab 300 mg via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
36021|NCT02392624|B1|Baseline|Omalizumab (Non-Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After Week 24, participants did not receive any treatment and only returned for a final follow-up visit (12 weeks after Week 24 visit).
36022|NCT02392624|P3|Participant Flow|Placebo (Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
36023|NCT02392624|P2|Participant Flow|Omalizumab (Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with omalizumab 300 mg via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their chronic idiopathic urticaria (CIU) (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
36024|NCT02392624|P1|Participant Flow|Omalizumab (Non-Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 milligrams (mg) via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks. After Week 24, participants did not receive any treatment and only returned for a final follow-up visit (12 weeks after Week 24 visit).
39992|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
36025|NCT02392624|O1|Outcome|Placebo (Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
36026|NCT02392624|O1|Outcome|Omalizumab (Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with omalizumab 300 mg via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
36027|NCT02392624|O2|Outcome|Placebo (Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
36028|NCT02392624|O1|Outcome|Omalizumab (Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with omalizumab 300 mg via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
36029|NCT02392624|O2|Outcome|Placebo (Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
36030|NCT02392624|O1|Outcome|Omalizumab (Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with omalizumab 300 mg via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
36031|NCT02392624|O2|Outcome|Placebo (Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
36032|NCT02392624|O1|Outcome|Omalizumab (Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with omalizumab 300 mg via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
36033|NCT02392624|E3|Reported Event|Placebo (Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
36034|NCT02392624|E2|Reported Event|Omalizumab (Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with omalizumab 300 mg via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48.
36035|NCT02392624|E1|Reported Event|Omalizumab (Non-Randomized Participants)|Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After Week 24, participants did not receive any treatment and only returned for a final follow-up visit (12 weeks after Week 24 visit).
36037|NCT02392377|B2|Baseline|Arm II (Combination Chemotherapy, Radiation Therapy, Surgery)|"INDUCTION: Patients receive mFOLFOX6 where they get oxaliplatin 85 mg/m2 intravenously on day 1, leucovorin 400 mg/m2 IV on day 1, 5-FU 400 mg/m2 IV on day 1 and then 5FU at 2400 mg/m2 IV to be administered over a 46 hour period. This is repeated every 2 weeks for 3 cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive oxaliplatin 85 mg/m2 IV on day 1 every 2 weeks for a total of 3 cycles (6 weeks) as well as 5FU 300 mg/m2/day over 96 hours via continuous infusion each week of radiation for a total of 6 weeks.~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
36038|NCT02392377|B1|Baseline|Arm I (Paclitaxel, Carboplatin, Radiation Therapy, Surgery)|"INDUCTION: Patients receive chemotherapy with carboplatin and paclitaxel. Patients receive carboplatin (AUC=2) and paclitaxel (90 mg/m2) intravenously on days 1 and 8 of a 21 day treatment cycle for two cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive carboplatin (AUC=2) and paclitaxel (50 mg/m2) intravenously once weekly for five weeks throughout the duration of their radiation which is daily (Monday through Friday).~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
36039|NCT02392377|P2|Participant Flow|Arm II (Combination Chemotherapy, Radiation Therapy, Surgery)|"INDUCTION: Patients receive mFOLFOX6 where they get oxaliplatin 85 mg/m2 intravenously on day 1, leucovorin 400 mg/m2 IV on day 1, 5-FU 400 mg/m2 IV on day 1 and then 5FU at 2400 mg/m2 IV to be administered over a 46 hour period. This is repeated every 2 weeks for 3 cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive oxaliplatin 85 mg/m2 IV on day 1 every 2 weeks for a total of 3 cycles (6 weeks) as well as 5FU 300 mg/m2/day over 96 hours via continuous infusion each week of radiation for a total of 6 weeks.~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
36040|NCT02392377|P1|Participant Flow|Arm I (Paclitaxel, Carboplatin, Radiation Therapy, Surgery)|"INDUCTION: Patients receive chemotherapy with carboplatin and paclitaxel. Patients receive carboplatin (AUC=2) and paclitaxel (90 mg/m2) intravenously on days 1 and 8 of a 21 day treatment cycle for two cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive carboplatin (AUC=2) and paclitaxel (50 mg/m2) intravenously once weekly for five weeks throughout the duration of their radiation which is daily (Monday through Friday).~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
36041|NCT02392377|O2|Outcome|Arm II (Combination Chemotherapy, Radiation Therapy, Surgery)|"INDUCTION: Patients receive mFOLFOX6 where they get oxaliplatin 85 mg/m2 intravenously on day 1, leucovorin 400 mg/m2 IV on day 1, 5-FU 400 mg/m2 IV on day 1 and then 5FU at 2400 mg/m2 IV to be administered over a 46 hour period. This is repeated every 2 weeks for 3 cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive oxaliplatin 85 mg/m2 IV on day 1 every 2 weeks for a total of 3 cycles (6 weeks) as well as 5FU 300 mg/m2/day over 96 hours via continuous infusion each week of radiation for a total of 6 weeks.~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
36042|NCT02392377|O1|Outcome|Arm I (Paclitaxel, Carboplatin, Radiation Therapy, Surgery)|"INDUCTION: Patients receive chemotherapy with carboplatin and paclitaxel. Patients receive carboplatin (AUC=2) and paclitaxel (90 mg/m2) intravenously on days 1 and 8 of a 21 day treatment cycle for two cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive carboplatin (AUC=2) and paclitaxel (50 mg/m2) intravenously once weekly for five weeks throughout the duration of their radiation which is daily (Monday through Friday).~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
36043|NCT02392377|O2|Outcome|Arm II (Combination Chemotherapy, Radiation Therapy, Surgery)|"INDUCTION: Patients receive mFOLFOX6 where they get oxaliplatin 85 mg/m2 intravenously on day 1, leucovorin 400 mg/m2 IV on day 1, 5-FU 400 mg/m2 IV on day 1 and then 5FU at 2400 mg/m2 IV to be administered over a 46 hour period. This is repeated every 2 weeks for 3 cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive oxaliplatin 85 mg/m2 IV on day 1 every 2 weeks for a total of 3 cycles (6 weeks) as well as 5FU 300 mg/m2/day over 96 hours via continuous infusion each week of radiation for a total of 6 weeks.~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
36044|NCT02392377|O1|Outcome|Arm I (Paclitaxel, Carboplatin, Radiation Therapy, Surgery)|"INDUCTION: Patients receive chemotherapy with carboplatin and paclitaxel. Patients receive carboplatin (AUC=2) and paclitaxel (90 mg/m2) intravenously on days 1 and 8 of a 21 day treatment cycle for two cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive carboplatin (AUC=2) and paclitaxel (50 mg/m2) intravenously once weekly for five weeks throughout the duration of their radiation which is daily (Monday through Friday).~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
36045|NCT02392377|O2|Outcome|Arm II (Combination Chemotherapy, Radiation Therapy, Surgery)|"INDUCTION: Patients receive mFOLFOX6 where they get oxaliplatin 85 mg/m2 intravenously on day 1, leucovorin 400 mg/m2 IV on day 1, 5-FU 400 mg/m2 IV on day 1 and then 5FU at 2400 mg/m2 IV to be administered over a 46 hour period. This is repeated every 2 weeks for 3 cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive oxaliplatin 85 mg/m2 IV on day 1 every 2 weeks for a total of 3 cycles (6 weeks) as well as 5FU 300 mg/m2/day over 96 hours via continuous infusion each week of radiation for a total of 6 weeks.~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
36046|NCT02392377|O1|Outcome|Arm I (Paclitaxel, Carboplatin, Radiation Therapy, Surgery)|"INDUCTION: Patients receive chemotherapy with carboplatin and paclitaxel. Patients receive carboplatin (AUC=2) and paclitaxel (90 mg/m2) intravenously on days 1 and 8 of a 21 day treatment cycle for two cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive carboplatin (AUC=2) and paclitaxel (50 mg/m2) intravenously once weekly for five weeks throughout the duration of their radiation which is daily (Monday through Friday).~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
36081|NCT02392000|O1|Outcome|WatchPAT and CBT-i Coach App|"Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia~WatchPAT sleep monitor: Self-management of insomnia using a mobile sleep device~CBT-i Coach mobile app: Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia"
36159|NCT02391116|O1|Outcome|CD79b Mutant|Included all CD79b mutant patients classified at baseline depending on the biomarker value.
36047|NCT02392377|O2|Outcome|Arm II (Combination Chemotherapy, Radiation Therapy, Surgery)|"INDUCTION: Patients receive mFOLFOX6 where they get oxaliplatin 85 mg/m2 intravenously on day 1, leucovorin 400 mg/m2 IV on day 1, 5-FU 400 mg/m2 IV on day 1 and then 5FU at 2400 mg/m2 IV to be administered over a 46 hour period. This is repeated every 2 weeks for 3 cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive oxaliplatin 85 mg/m2 IV on day 1 every 2 weeks for a total of 3 cycles (6 weeks) as well as 5FU 300 mg/m2/day over 96 hours via continuous infusion each week of radiation for a total of 6 weeks.~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
36048|NCT02392377|O1|Outcome|Arm I (Paclitaxel, Carboplatin, Radiation Therapy, Surgery)|"INDUCTION: Patients receive chemotherapy with carboplatin and paclitaxel. Patients receive carboplatin (AUC=2) and paclitaxel (90 mg/m2) intravenously on days 1 and 8 of a 21 day treatment cycle for two cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive carboplatin (AUC=2) and paclitaxel (50 mg/m2) intravenously once weekly for five weeks throughout the duration of their radiation which is daily (Monday through Friday).~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
36049|NCT02392377|O2|Outcome|Arm II (Combination Chemotherapy, Radiation Therapy, Surgery)|"INDUCTION: Patients receive mFOLFOX6 where they get oxaliplatin 85 mg/m2 intravenously on day 1, leucovorin 400 mg/m2 IV on day 1, 5-FU 400 mg/m2 IV on day 1 and then 5FU at 2400 mg/m2 IV to be administered over a 46 hour period. This is repeated every 2 weeks for 3 cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive oxaliplatin 85 mg/m2 IV on day 1 every 2 weeks for a total of 3 cycles (6 weeks) as well as 5FU 300 mg/m2/day over 96 hours via continuous infusion each week of radiation for a total of 6 weeks.~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
36050|NCT02392377|O1|Outcome|Arm I (Paclitaxel, Carboplatin, Radiation Therapy, Surgery)|"INDUCTION:Patients receive chemotherapy with carboplatin and paclitaxel. Patients receive carboplatin (AUC=2) and paclitaxel (90 mg/m2) intravenously on days 1 and 8 of a 21 day treatment cycle for two cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive carboplatin (AUC=2) and paclitaxel (50 mg/m2) intravenously once weekly for five weeks throughout the duration of their radiation which is daily (Monday through Friday).~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
36051|NCT02392377|O2|Outcome|Arm II (Combination Chemotherapy, Radiation Therapy, Surgery)|"INDUCTION: Patients receive mFOLFOX6 where they get oxaliplatin 85 mg/m2 intravenously on day 1, leucovorin 400 mg/m2 IV on day 1, 5-FU 400 mg/m2 IV on day 1 and then 5FU at 2400 mg/m2 IV to be administered over a 46 hour period. This is repeated every 2 weeks for 3 cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive oxaliplatin 85 mg/m2 IV on day 1 every 2 weeks for a total of 3 cycles (6 weeks) as well as 5FU 300 mg/m2/day over 96 hours via continuous infusion each week of radiation for a total of 6 weeks.~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
36052|NCT02392377|O1|Outcome|Arm I (Paclitaxel, Carboplatin, Radiation Therapy, Surgery)|"Experimental: Arm I (paclitaxel, carboplatin, radiation therapy, surgery) INDUCTION: Patients receive chemotherapy with carboplatin and paclitaxel. Patients receive carboplatin (AUC=2) and paclitaxel (90 mg/m2) intravenously on days 1 and 8 of a 21 day treatment cycle for two cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive carboplatin (AUC=2) and paclitaxel (50 mg/m2) intravenously once weekly for five weeks throughout the duration of their radiation which is daily (Monday through Friday).~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
36053|NCT02392377|O2|Outcome|Arm II (Combination Chemotherapy, Radiation Therapy, Surgery)|"INDUCTION: Patients receive mFOLFOX6 where they get oxaliplatin 85 mg/m2 intravenously on day 1, leucovorin 400 mg/m2 IV on day 1, 5-FU 400 mg/m2 IV on day 1 and then 5FU at 2400 mg/m2 IV to be administered over a 46 hour period. This is repeated every 2 weeks for 3 cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive oxaliplatin 85 mg/m2 IV on day 1 every 2 weeks for a total of 3 cycles (6 weeks) as well as 5FU 300 mg/m2/day over 96 hours via continuous infusion each week of radiation for a total of 6 weeks.~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
36054|NCT02392377|O1|Outcome|Arm I (Paclitaxel, Carboplatin, Radiation Therapy, Surgery)|"INDUCTION: Patients receive chemotherapy with carboplatin and paclitaxel. Patients receive carboplatin (AUC=2) and paclitaxel (90 mg/m2) intravenously on days 1 and 8 of a 21 day treatment cycle for two cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive carboplatin (AUC=2) and paclitaxel (50 mg/m2) intravenously once weekly for five weeks throughout the duration of their radiation which is daily (Monday through Friday).~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
36055|NCT02392377|O2|Outcome|Arm II (Combination Chemotherapy, Radiation Therapy, Surgery)|"INDUCTION: Patients receive mFOLFOX6 where they get oxaliplatin 85 mg/m2 intravenously on day 1, leucovorin 400 mg/m2 IV on day 1, 5-FU 400 mg/m2 IV on day 1 and then 5FU at 2400 mg/m2 IV to be administered over a 46 hour period. This is repeated every 2 weeks for 3 cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive oxaliplatin 85 mg/m2 IV on day 1 every 2 weeks for a total of 3 cycles (6 weeks) as well as 5FU 300 mg/m2/day over 96 hours via continuous infusion each week of radiation for a total of 6 weeks.~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
36056|NCT02392377|O1|Outcome|Arm I (Paclitaxel, Carboplatin, Radiation Therapy, Surgery)|"INDUCTION: Patients receive chemotherapy with carboplatin and paclitaxel. Patients receive carboplatin (AUC=2) and paclitaxel (90 mg/m2) intravenously on days 1 and 8 of a 21 day treatment cycle for two cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive carboplatin (AUC=2) and paclitaxel (50 mg/m2) intravenously once weekly for five weeks throughout the duration of their radiation which is daily (Monday through Friday).~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
36082|NCT02392000|O1|Outcome|WatchPAT and CBT-i Coach App|"Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia~WatchPAT sleep monitor: Self-management of insomnia using a mobile sleep device~CBT-i Coach mobile app: Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia"
39993|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
36057|NCT02392377|O2|Outcome|Arm II (Combination Chemotherapy, Radiation Therapy, Surgery)|"INDUCTION: Patients receive mFOLFOX6 where they get oxaliplatin 85 mg/m2 intravenously on day 1, leucovorin 400 mg/m2 IV on day 1, 5-FU 400 mg/m2 IV on day 1 and then 5FU at 2400 mg/m2 IV to be administered over a 46 hour period. This is repeated every 2 weeks for 3 cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive oxaliplatin 85 mg/m2 IV on day 1 every 2 weeks for a total of 3 cycles (6 weeks) as well as 5FU 300 mg/m2/day over 96 hours via continuous infusion each week of radiation for a total of 6 weeks.~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
36058|NCT02392377|O1|Outcome|Arm I (Paclitaxel, Carboplatin, Radiation Therapy, Surgery)|"INDUCTION: Patients receive chemotherapy with carboplatin and paclitaxel. Patients receive carboplatin (AUC=2) and paclitaxel (90 mg/m2) intravenously on days 1 and 8 of a 21 day treatment cycle for two cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive carboplatin (AUC=2) and paclitaxel (50 mg/m2) intravenously once weekly for five weeks throughout the duration of their radiation which is daily (Monday through Friday).~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
36059|NCT02392377|O2|Outcome|Arm II (Combination Chemotherapy, Radiation Therapy, Surgery)|"INDUCTION: Patients receive mFOLFOX6 where they get oxaliplatin 85 mg/m2 intravenously on day 1, leucovorin 400 mg/m2 IV on day 1, 5-FU 400 mg/m2 IV on day 1 and then 5FU at 2400 mg/m2 IV to be administered over a 46 hour period. This is repeated every 2 weeks for 3 cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive oxaliplatin 85 mg/m2 IV on day 1 every 2 weeks for a total of 3 cycles (6 weeks) as well as 5FU 300 mg/m2/day over 96 hours via continuous infusion each week of radiation for a total of 6 weeks.~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
36060|NCT02392377|O1|Outcome|Arm I (Paclitaxel, Carboplatin, Radiation Therapy, Surgery)|"INDUCTION: Patients receive chemotherapy with carboplatin and paclitaxel. Patients receive carboplatin (AUC=2) and paclitaxel (90 mg/m2) intravenously on days 1 and 8 of a 21 day treatment cycle for two cycles (total of 6 weeks).~CHEMORADIATION THERAPY: Patients receive carboplatin (AUC=2) and paclitaxel (50 mg/m2) intravenously once weekly for five weeks throughout the duration of their radiation which is daily (Monday through Friday).~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team."
36061|NCT02392377|E2|Reported Event|Arm II (Combination Chemotherapy, Radiation Therapy, Surgery)|"INDUCTION: Patients receive oxaliplatin IV over 2-6 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity.~CHEMORADIATION THERAPY: Patients receive oxaliplatin IV over 2-6 hours on days 1, 15, and 29 and fluorouracil IV continuously over 96 hours on days 1, 8, 15, 22, and 29. Patients also undergo radiation therapy QD 5 days a week for 5-6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team.~Oxaliplatin: Given IV~Leucovorin Calcium: Given IV~Fluorouracil: Given IV~Radiation Therapy: Undergo radiation therapy~Therapeutic Conventional Surgery: Undergo esophagectomy~Laboratory Biomarker Analysis: Correlative studies"
36062|NCT02392377|E1|Reported Event|Arm I (Paclitaxel, Carboplatin, Radiation Therapy, Surgery)|"INDUCTION: Patients receive paclitaxel IV over 60 minutes and carboplatin intravenously IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~CHEMORADIATION THERAPY: Patients receive paclitaxel IVPB over 60 minutes and carboplatin IVPB over 30 minutes on days 8 and 22. Patients also undergo radiation therapy QD 5 days a week. Treatment continues for 5-6 weeks in the absence of disease progression or unacceptable toxicity.~SURGERY: Approximately 4-10 weeks after completion of chemoradiation therapy, patients undergo esophagectomy at the discretion of the treating team.~Paclitaxel: Given IV or IVPB~Carboplatin: Given IV or IVPB~Radiation Therapy: Undergo radiation therapy~Therapeutic Conventional Surgery: Undergo esophagectomy~Laboratory Biomarker Analysis: Correlative studies"
36063|NCT02392247|B1|Baseline|Cardiac Surgery Patients|Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. Paired blood samples were assessed by thromboelastography (TEG; current care option) and by Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry
36064|NCT02392247|P1|Participant Flow|Cardiac Surgery Patients|"Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. The study compares output of two technologies for determination of point of care coagulation function: thromboelastography (TEG; current care option) and the new technology Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry. Blood was collected at four time points: baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU.~Blood specimen collection"
36065|NCT02392247|O1|Outcome|Cardiac Surgery Patients|"Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. The study compares output of two technologies for determination of point of care coagulation function: thromboelastography (TEG; current care option) and the new technology Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry. Blood was collected at four time points: baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU.~Blood specimen collection"
36066|NCT02392247|O1|Outcome|Cardiac Surgery Patients|"Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. The study compares output of two technologies for determination of point of care coagulation function: thromboelastography (TEG; current care option) and the new technology Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry. Blood was collected at four time points: baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU.~Blood specimen collection"
36067|NCT02392247|E1|Reported Event|Cardiac Surgery Patients|"Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. The study compares output of two technologies for determination of point of care coagulation function: thromboelastography (TEG; current care option) and the new technology Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry~Blood specimen collection"
36114|NCT02391116|O2|Outcome|Germinal Center B-cell-like (GCB)|Included all patients with germinal center B-cell-like (GCB) DLBCL classified at baseline depending on the biomarker value.
39994|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
36068|NCT02392208|B1|Baseline|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.~Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
36069|NCT02392208|P1|Participant Flow|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.~Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
36070|NCT02392208|O1|Outcome|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.~Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
36071|NCT02392208|O1|Outcome|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.~Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
36072|NCT02392208|O1|Outcome|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.~Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
36073|NCT02392208|O1|Outcome|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.~Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
36074|NCT02392208|O1|Outcome|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.~Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
36075|NCT02392208|O1|Outcome|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.~Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
36076|NCT02392208|E2|Reported Event|Telavancin After Hemodialysis|"Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin immediately after their normally scheduled hemodialysis session.~Telavancin: A single 5 mg/kg dose of telavancin is administered intravenously (IV).~Pharmacokinetic Blood Sampling: Blood samples are collected to assess telavancin plasma concentrations."
36077|NCT02392208|E1|Reported Event|Telavancin Before Hemodialysis|"Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin before their normally scheduled hemodialysis session.~Telavancin: A single 5 mg/kg dose of telavancin is administered intravenously (IV).~Pharmacokinetic Blood Sampling: Blood samples are collected to assess telavancin plasma concentrations."
36078|NCT02392000|B1|Baseline|WatchPAT and CBT-i Coach App|"Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia~WatchPAT sleep monitor: Self-management of insomnia using a mobile sleep device~CBT-i Coach mobile app: Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia"
36079|NCT02392000|P1|Participant Flow|WatchPAT and CBT-i Coach App|"Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia~WatchPAT sleep monitor: Self-management of insomnia using a mobile sleep device~CBT-i Coach mobile app: Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia"
36080|NCT02392000|O1|Outcome|WatchPAT and CBT-i Coach App|"Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia~WatchPAT sleep monitor: Self-management of insomnia using a mobile sleep device~CBT-i Coach mobile app: Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia"
36115|NCT02391116|O1|Outcome|Activated B-cell-like (ABC)|Included all patients with activated B-cell-like (ABC) DLBCL classified at baseline depending on the biomarker value.
36083|NCT02392000|O1|Outcome|WatchPAT and CBT-i Coach App|"Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia~WatchPAT sleep monitor: Self-management of insomnia using a mobile sleep device~CBT-i Coach mobile app: Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia"
36084|NCT02392000|O1|Outcome|WatchPAT and CBT-i Coach Mobile App|"Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia~WatchPAT sleep monitor: Self-management of insomnia using a mobile sleep device~CBT-i Coach mobile app: Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia"
36085|NCT02392000|E1|Reported Event|WatchPAT and CBT-i Coach App|"Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia~WatchPAT sleep monitor: Self-management of insomnia using a mobile sleep device~CBT-i Coach mobile app: Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia"
36086|NCT02391714|B3|Baseline|Total|Total of all reporting groups
36087|NCT02391714|B2|Baseline|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Nitrous oxide: Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask."
36088|NCT02391714|B1|Baseline|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Oxygen: 100% oxygen via nasal mask."
36089|NCT02391714|P2|Participant Flow|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Nitrous oxide: Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask."
36090|NCT02391714|P1|Participant Flow|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Oxygen: 100% oxygen via nasal mask."
36091|NCT02391714|O2|Outcome|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Povidone-Iodine: Povidone-Iodine 10% w/w antiseptic swab for the cervix prior to IUD insertion.~Chlorhexidine: For patients"
36092|NCT02391714|O1|Outcome|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Povidone-Iodine: Povidone-Iodine 10% w/w antiseptic swab for the cervix prior to IUD insertion.~Chlorhexidine: For patients with allergy to iodine - 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol antiseptic"
36116|NCT02391116|O3|Outcome|CD79b Status Missing|Included all patients with missing CD79b status classified at baseline.
36117|NCT02391116|O2|Outcome|CD79b Wild-type|Included all CD79b wild-type patients classified at baseline depending on biomarker value.
36118|NCT02391116|O1|Outcome|CD79b Mutant|Included all CD79b mutant patients classified at baseline depending on the biomarker value.
36119|NCT02391116|O1|Outcome|Copanlisib (BAY80-6946)|Patients assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment.
36093|NCT02391714|O2|Outcome|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Povidone-Iodine: Povidone-Iodine 10% w/w antiseptic swab for the cervix prior to IUD insertion.~Chlorhexidine: For patients"
36094|NCT02391714|O1|Outcome|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Povidone-Iodine: Povidone-Iodine 10% w/w antiseptic swab for the cervix prior to IUD insertion.~Chlorhexidine: For patients with allergy to iodine - 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol antiseptic"
36095|NCT02391714|O2|Outcome|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Nitrous oxide: Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask."
36096|NCT02391714|O1|Outcome|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Oxygen: 100% oxygen via nasal mask."
36097|NCT02391714|E2|Reported Event|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Nitrous oxide: Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask."
36098|NCT02391714|E1|Reported Event|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Oxygen: 100% oxygen via nasal mask."
36099|NCT02391311|B3|Baseline|Total|Total of all reporting groups
36100|NCT02391311|B2|Baseline|Active tDCS + Cognitive Remediation|"Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
36101|NCT02391311|B1|Baseline|Sham tDCS + Cognitive Remediation|"Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
36157|NCT02391116|O1|Outcome|Activated B-cell-like (ABC)|Included all patients with activated B-cell-like (ABC) DLBCL classified at baseline depending on the biomarker value.
39995|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
36102|NCT02391311|P2|Participant Flow|Active tDCS + Cognitive Remediation|"Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
36103|NCT02391311|P1|Participant Flow|Sham tDCS + Cognitive Remediation|"Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
36104|NCT02391311|O2|Outcome|Active tDCS + Cognitive Remediation|"Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
36105|NCT02391311|O1|Outcome|Sham tDCS + Cognitive Remediation|"Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
36106|NCT02391311|O2|Outcome|Active tDCS + Cognitive Remediation|"Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
36107|NCT02391311|O1|Outcome|Sham tDCS + Cognitive Remediation|"Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
36108|NCT02391311|E2|Reported Event|Active tDCS + Cognitive Remediation|"Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
36109|NCT02391311|E1|Reported Event|Sham tDCS + Cognitive Remediation|"Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
36110|NCT02391116|B1|Baseline|Copanlisib (BAY80-6946)|Patients assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment.
36111|NCT02391116|P1|Participant Flow|Copanlisib (BAY80-6946)|Patients assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment.
36112|NCT02391116|O4|Outcome|DLBCL/COO Subtype Missing|Included all patients with missing DLBCL/COO subtype classified at baseline.
36113|NCT02391116|O3|Outcome|Unclassifiable|Included all patients with unclassifiable DLBCL/COO subtype at baseline.
36120|NCT02391116|O1|Outcome|Copanlisib (BAY80-6946)|Patients assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment.
36121|NCT02391116|O1|Outcome|Copanlisib (BAY80-6946)|Patients assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment.
36122|NCT02391116|O4|Outcome|DLBCL/COO Subtype Missing|Included all patients with missing DLBCL/COO subtype classified at baseline.
36123|NCT02391116|O3|Outcome|Unclassifiable|Included all patients with unclassifiable DLBCL/COO subtype at baseline.
36124|NCT02391116|O2|Outcome|Germinal Center B-cell-like (GCB)|Included all patients with germinal center B-cell-like (GCB) DLBCL classified at baseline depending on the biomarker value.
36125|NCT02391116|O1|Outcome|Activated B-cell-like (ABC)|Included all patients with activated B-cell-like (ABC) DLBCL classified at baseline depending on the biomarker value.
36126|NCT02391116|O3|Outcome|CD79b Status Missing|Included all patients with missing CD79b status classified at baseline.
36127|NCT02391116|O2|Outcome|CD79b Wild-type|Included all CD79b wild-type patients classified at baseline depending on biomarker value.
36128|NCT02391116|O1|Outcome|CD79b Mutant|Included all CD79b mutant patients classified at baseline depending on the biomarker value.
36129|NCT02391116|O1|Outcome|Copanlisib (BAY80-6946)|Patients assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment.
36130|NCT02391116|O1|Outcome|Copanlisib (BAY80-6946)|Patients assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment.
36131|NCT02391116|O4|Outcome|DLBCL/COO Subtype Missing|Included all patients with missing DLBCL/COO subtype classified at baseline.
36132|NCT02391116|O3|Outcome|Unclassifiable|Included all patients with unclassifiable DLBCL/COO subtype at baseline.
36133|NCT02391116|O2|Outcome|Germinal Center B-cell-like (GCB)|Included all patients with germinal center B-cell-like (GCB) DLBCL classified at baseline depending on the biomarker value.
36134|NCT02391116|O1|Outcome|Activated B-cell-like (ABC)|Included all patients with activated B-cell-like (ABC) DLBCL classified at baseline depending on the biomarker value.
36135|NCT02391116|O3|Outcome|CD79b Status Missing|Included all patients with missing CD79b status classified at baseline.
36136|NCT02391116|O2|Outcome|CD79b Wild-type|Included all CD79b wild-type patients classified at baseline depending on biomarker value.
36137|NCT02391116|O1|Outcome|CD79b Mutant|Included all CD79b mutant patients classified at baseline depending on the biomarker value.
36138|NCT02391116|O1|Outcome|Copanlisib (BAY80-6946)|Patients assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment.
36139|NCT02391116|O4|Outcome|DLBCL/COO Subtype Missing|Included all patients with missing DLBCL/COO subtype classified at baseline.
36140|NCT02391116|O3|Outcome|Unclassifiable|Included all patients with unclassifiable DLBCL/COO subtype at baseline.
36141|NCT02391116|O2|Outcome|Germinal Center B-cell-like (GCB)|Included all patients with germinal center B-cell-like (GCB) DLBCL classified at baseline depending on the biomarker value.
36142|NCT02391116|O1|Outcome|Activated B-cell-like (ABC)|Included all patients with activated B-cell-like (ABC) DLBCL classified at baseline depending on the biomarker value.
36143|NCT02391116|O3|Outcome|CD79b Status Missing|Included all patients with missing CD79b status classified at baseline.
36144|NCT02391116|O2|Outcome|CD79b Wild-type|Included all CD79b wild-type patients classified at baseline depending on biomarker value.
36145|NCT02391116|O1|Outcome|CD79b Mutant|Included all CD79b mutant patients classified at baseline depending on the biomarker value.
36146|NCT02391116|O1|Outcome|Copanlisib (BAY80-6946)|Patients assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment.
36147|NCT02391116|O4|Outcome|DLBCL/COO Subtype Missing|Included all patients with missing DLBCL/COO subtype classified at baseline.
36148|NCT02391116|O3|Outcome|Unclassifiable|Included all patients with unclassifiable DLBCL/COO subtype at baseline.
36149|NCT02391116|O2|Outcome|Germinal Center B-cell-like (GCB)|Included all patients with germinal center B-cell-like (GCB) DLBCL classified at baseline depending on the biomarker value.
36150|NCT02391116|O1|Outcome|Activated B-cell-like (ABC)|Included all patients with activated B-cell-like (ABC) DLBCL classified at baseline depending on the biomarker value.
36151|NCT02391116|O3|Outcome|CD79b Status Missing|Included all patients with missing CD79b status classified at baseline.
36152|NCT02391116|O2|Outcome|CD79b Wild-type|Included all CD79b wild-type patients classified at baseline depending on biomarker value.
36153|NCT02391116|O1|Outcome|CD79b Mutant|Included all CD79b wild-type patients classified at baseline depending on biomarker value.
36154|NCT02391116|O1|Outcome|Copanlisib (BAY80-6946)|Patients assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment.
36155|NCT02391116|O3|Outcome|Unclassifiable|Included all patients with unclassifiable DLBCL/COO subtype at baseline.
36156|NCT02391116|O2|Outcome|Germinal Center B-cell-like (GCB)|Included all patients with germinal center B-cell-like (GCB) DLBCL classified at baseline depending on the biomarker value.
39996|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
36160|NCT02391116|O1|Outcome|Copanlisib (BAY80-6946)|Patients assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment.
36161|NCT02391116|O1|Outcome|Copanlisib (BAY80-6946)|Patients assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment.
36162|NCT02391116|E1|Reported Event|Copanlisib (BAY80-6946)|Patients assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment.
36163|NCT02391038|B1|Baseline|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
36164|NCT02391038|P3|Participant Flow|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36165|NCT02391038|P2|Participant Flow|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36166|NCT02391038|P1|Participant Flow|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36167|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
36168|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, injection, intravenously on Day 1 of 3 week cycles of Phase 2, until disease progression or unacceptable toxicity. Dosage for this phase was determined from results of Phase 1 MTD/RP2D.
36169|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
36170|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
36171|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
36172|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
36173|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
36174|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
36175|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
36176|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
36177|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
36178|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
36179|NCT02391038|O1|Outcome|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
36180|NCT02391038|O1|Outcome|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
36181|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
36182|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36183|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36184|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36185|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36186|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36187|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36188|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36189|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36190|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36191|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36192|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36193|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36194|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36195|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36196|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36197|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36198|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36199|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36200|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36201|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36202|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36203|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36204|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36205|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36206|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36207|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36208|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36209|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36210|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36211|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36212|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36488|NCT02388763|O2|Outcome|1DAVTE|Narafilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
36213|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36214|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36215|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36216|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36217|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36218|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36219|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36220|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36221|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36222|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36223|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36224|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36225|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36226|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36227|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36228|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36229|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36230|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36231|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36232|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36233|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36234|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36235|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36236|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36237|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36238|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36239|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36240|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36241|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36489|NCT02388763|O1|Outcome|MyDay|Stenfilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
36242|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36243|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36244|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36245|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36246|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36247|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36248|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36249|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36250|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36251|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36252|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36253|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36254|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36255|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36256|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36257|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36258|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36259|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36260|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36261|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36262|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36263|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36264|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36265|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36266|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36267|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36268|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36269|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36270|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36490|NCT02388763|O2|Outcome|1DAVTE|Narafilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
36271|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
36272|NCT02391038|O1|Outcome|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
36273|NCT02391038|O1|Outcome|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
36274|NCT02391038|O1|Outcome|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
36275|NCT02391038|O1|Outcome|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
36276|NCT02391038|O1|Outcome|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
36277|NCT02391038|O1|Outcome|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
36278|NCT02391038|E1|Reported Event|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
36279|NCT02390219|B1|Baseline|LUM/IVA|Participants received LUM 400 mg in combination with IVA 250 mg as FDC tablet orally q12h for 24 weeks. A reduced initial dose of LUM 200 mg in combination with IVA 125 mg FDC tablet orally q12h was permitted.
36280|NCT02390219|P1|Participant Flow|LUM/IVA|Participants received lumacaftor (LUM) 400 milligram (mg) in combination with ivacaftor (IVA) 250 mg as fixed-dose combination (FDC) tablet orally every 12 hours (q12h) for 24 weeks. A reduced initial dose of LUM 200 mg in combination with IVA 125 mg FDC tablet orally q12h was permitted.
36281|NCT02390219|O1|Outcome|LUM/IVA|Participants received LUM 400 mg in combination with IVA 250 mg as FDC tablet orally q12h for 24 weeks. A reduced initial dose of LUM 200 mg in combination with IVA 125 mg FDC tablet orally q12h was permitted.
36282|NCT02390219|O1|Outcome|LUM/IVA|Participants received LUM 400 mg in combination with IVA 250 mg as FDC tablet orally q12h for 24 weeks. A reduced initial dose of LUM 200 mg in combination with IVA 125 mg FDC tablet orally q12h was permitted.
36283|NCT02390219|O1|Outcome|LUM/IVA|Participants received LUM 400 mg in combination with IVA 250 mg as FDC tablet orally q12h for 24 weeks. A reduced initial dose of LUM 200 mg in combination with IVA 125 mg FDC tablet orally q12h was permitted.
36284|NCT02390219|O1|Outcome|LUM/IVA|Participants received LUM 400 mg in combination with IVA 250 mg as FDC tablet orally q12h for 24 weeks. A reduced initial dose of LUM 200 mg in combination with IVA 125 mg FDC tablet orally q12h was permitted.
36285|NCT02390219|O1|Outcome|LUM/IVA|Participants received LUM 400 mg in combination with IVA 250 mg as FDC tablet orally q12h for 24 weeks. A reduced initial dose of LUM 200 mg in combination with IVA 125 mg FDC tablet orally q12h was permitted.
36286|NCT02390219|O1|Outcome|LUM/IVA|Participants received LUM 400 mg in combination with IVA 250 mg as FDC tablet orally q12h for 24 weeks. A reduced initial dose of LUM 200 mg in combination with IVA 125 mg FDC tablet orally q12h was permitted.
36287|NCT02390219|O1|Outcome|LUM/IVA|Participants received LUM 400 mg in combination with IVA 250 mg as FDC tablet orally q12h for 24 weeks. A reduced initial dose of LUM 200 mg in combination with IVA 125 mg FDC tablet orally q12h was permitted.
36288|NCT02390219|E1|Reported Event|LUM/IVA|Participants received LUM 400 mg in combination with IVA 250 mg as FDC tablet orally q12h for 24 weeks. A reduced initial dose of LUM 200 mg in combination with IVA 125 mg FDC tablet orally q12h was permitted.
36289|NCT02390167|B1|Baseline|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
36290|NCT02390167|P1|Participant Flow|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
36291|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
36292|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
36293|NCT02390167|O1|Outcome|Persons With Diabetes|"Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
36294|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
36491|NCT02388763|O1|Outcome|MyDay|Stenfilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
36295|NCT02390167|O1|Outcome|Persons With Diabetes|"Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
36296|NCT02390167|O1|Outcome|Persons With Diabetes|"Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
36297|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
36298|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
36299|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
36300|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
36301|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
36302|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
36303|NCT02390167|O1|Outcome|Persons With Diabetes|"Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
36304|NCT02390167|O1|Outcome|Persons With Diabetes|"Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
36305|NCT02390167|O1|Outcome|Persons With Diabetes|"Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary palm blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
36306|NCT02390167|O1|Outcome|Persons With Diabetes|"Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
36307|NCT02390167|E1|Reported Event|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
36308|NCT02389881|B8|Baseline|Total|Total of all reporting groups
36309|NCT02389881|B7|Baseline|Cohort 4 Elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36310|NCT02389881|B6|Baseline|Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
36311|NCT02389881|B5|Baseline|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
36312|NCT02389881|B4|Baseline|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
36313|NCT02389881|B3|Baseline|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36314|NCT02389881|B2|Baseline|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36315|NCT02389881|B1|Baseline|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36316|NCT02389881|P7|Participant Flow|Cohort 4 Elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36317|NCT02389881|P6|Participant Flow|Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
36318|NCT02389881|P5|Participant Flow|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
36319|NCT02389881|P4|Participant Flow|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
36320|NCT02389881|P3|Participant Flow|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36321|NCT02389881|P2|Participant Flow|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36322|NCT02389881|P1|Participant Flow|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
39997|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
36323|NCT02389881|O4|Outcome|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
36324|NCT02389881|O3|Outcome|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36325|NCT02389881|O2|Outcome|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36326|NCT02389881|O1|Outcome|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36327|NCT02389881|O5|Outcome|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
36328|NCT02389881|O4|Outcome|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
36329|NCT02389881|O3|Outcome|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36330|NCT02389881|O2|Outcome|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36331|NCT02389881|O1|Outcome|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36332|NCT02389881|O5|Outcome|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
36333|NCT02389881|O4|Outcome|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
36334|NCT02389881|O3|Outcome|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36335|NCT02389881|O2|Outcome|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36336|NCT02389881|O1|Outcome|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36337|NCT02389881|O5|Outcome|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
36338|NCT02389881|O4|Outcome|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
36339|NCT02389881|O3|Outcome|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36340|NCT02389881|O2|Outcome|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36341|NCT02389881|O1|Outcome|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36342|NCT02389881|O7|Outcome|Cohort 4 Elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36343|NCT02389881|O6|Outcome|Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
36344|NCT02389881|O5|Outcome|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
36345|NCT02389881|O4|Outcome|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
36346|NCT02389881|O3|Outcome|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36347|NCT02389881|O2|Outcome|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36348|NCT02389881|O1|Outcome|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36349|NCT02389881|O7|Outcome|Cohort 4 Elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36350|NCT02389881|O6|Outcome|Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
36351|NCT02389881|O5|Outcome|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
36352|NCT02389881|O4|Outcome|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
36353|NCT02389881|O3|Outcome|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36354|NCT02389881|O2|Outcome|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36355|NCT02389881|O1|Outcome|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36356|NCT02389881|O7|Outcome|Cohort 4 Elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36357|NCT02389881|O6|Outcome|Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
36358|NCT02389881|O5|Outcome|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
36359|NCT02389881|O4|Outcome|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
39998|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
36360|NCT02389881|O3|Outcome|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36361|NCT02389881|O2|Outcome|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36362|NCT02389881|O1|Outcome|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36363|NCT02389881|E7|Reported Event|Cohort 4 Elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36364|NCT02389881|E6|Reported Event|Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
36365|NCT02389881|E5|Reported Event|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
36366|NCT02389881|E4|Reported Event|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
36367|NCT02389881|E3|Reported Event|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36368|NCT02389881|E2|Reported Event|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36369|NCT02389881|E1|Reported Event|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
36370|NCT02389452|B1|Baseline|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
36371|NCT02389452|P1|Participant Flow|Synvisc-One|Single 6 mL intra-articular (IA) injection of Synvisc-One (48 mg of cross-linked hylan polymer) at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52 ) when measured on a 0-100 mm scale, where higher score indicate higher pain.
36372|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
36373|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
36374|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
36375|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
36376|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
36377|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
36378|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
36379|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
36402|NCT02389374|O3|Outcome|Artemether-lumefantrine Primaquine 14days|"mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: 14 days"
36380|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
36381|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
36382|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
36383|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
36384|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
36385|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
36386|NCT02389452|E2|Reported Event|Synvisc-One: Local Adverse Event|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician’s discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain. Local adverse events were defined as any adverse event which occurred in the treated joint.
36387|NCT02389452|E1|Reported Event|Synvisc-One: Systemic Adverse Event|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician’s discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.Systemic adverse events were defined as any adverse event which occurred anywhere other than in the treated joint.
36388|NCT02389374|B4|Baseline|Total|Total of all reporting groups
36389|NCT02389374|B3|Baseline|Artemether-lumefantrine Primaquine 14days|"mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: 14 days"
36390|NCT02389374|B2|Baseline|Artemether-lumefantrine Primaquine 1day|"P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: single dose"
36391|NCT02389374|B1|Baseline|Chloroquine Primaquine 14days|"P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines~chloroquine: standard dose~Primaquine: 14 days"
36392|NCT02389374|P3|Participant Flow|Artemether-lumefantrine Primaquine 14days|"mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: 14 days"
36393|NCT02389374|P2|Participant Flow|Artemether-lumefantrine Primaquine 1day|"P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: single dose"
36394|NCT02389374|P1|Participant Flow|Chloroquine Primaquine 14days|"P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines~chloroquine: standard dose~Primaquine: 14 days"
36395|NCT02389374|O1|Outcome|All Malaria Patients|single Arm/Group for all participants
36396|NCT02389374|O3|Outcome|Artemether-lumefantrine Primaquine 14days|"mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: 14 days"
36397|NCT02389374|O2|Outcome|Artemether-lumefantrine Primaquine 1day|"P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: single dose"
36398|NCT02389374|O1|Outcome|Chloroquine Primaquine 14days|"P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines~chloroquine: standard dose~Primaquine: 14 days"
36399|NCT02389374|O3|Outcome|Artemether-lumefantrine Primaquine 14days|"mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: 14 days"
36400|NCT02389374|O2|Outcome|Artemether-lumefantrine Primaquine 1day|"P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: single dose"
36401|NCT02389374|O1|Outcome|Chloroquine Primaquine 14days|"P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines~chloroquine: standard dose~Primaquine: 14 days"
36437|NCT02389088|O7|Outcome|Phase II - Week 5 - 0 Hours|
36403|NCT02389374|O2|Outcome|Artemether-lumefantrine Primaquine 1day|"P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: single dose"
36404|NCT02389374|O1|Outcome|Chloroquine Primaquine 14days|"P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines~chloroquine: standard dose~Primaquine: 14 days"
36405|NCT02389374|O3|Outcome|Artemether-lumefantrine Primaquine 14days|"mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: 14 days"
36406|NCT02389374|O2|Outcome|Artemether-lumefantrine Primaquine 1day|"P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: single dose"
36407|NCT02389374|O1|Outcome|Chloroquine Primaquine 14days|"P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines~chloroquine: standard dose~Primaquine: 14 days"
36408|NCT02389374|O3|Outcome|Artemether-lumefantrine Primaquine 14days|"mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: 14 days"
36409|NCT02389374|O2|Outcome|Artemether-lumefantrine Primaquine 1day|"P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: single dose"
36410|NCT02389374|O1|Outcome|Chloroquine Primaquine 14days|"P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines~chloroquine: standard dose~Primaquine: 14 days"
36411|NCT02389374|O3|Outcome|Artemether-lumefantrine Primaquine 14days|"mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: 14 days"
36412|NCT02389374|O2|Outcome|Artemether-lumefantrine Primaquine 1day|"P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: single dose"
36413|NCT02389374|O1|Outcome|Chloroquine Primaquine 14days|"P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines~chloroquine: standard dose~Primaquine: 14 days"
36414|NCT02389374|O3|Outcome|Artemether-lumefantrine Primaquine 14days|"mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: 14 days"
36415|NCT02389374|O2|Outcome|Artemether-lumefantrine Primaquine 1day|"P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: single dose"
36416|NCT02389374|O1|Outcome|Chloroquine Primaquine 14days|"P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines~chloroquine: standard dose~Primaquine: 14 days"
36417|NCT02389374|O3|Outcome|Artemether-lumefantrine Primaquine 14days|"mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: 14 days"
36418|NCT02389374|O2|Outcome|Artemether-lumefantrine Primaquine 1day|"P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: single dose"
36419|NCT02389374|O1|Outcome|Chloroquine Primaquine 14days|"P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines~chloroquine: standard dose~Primaquine: 14 days"
36420|NCT02389374|E3|Reported Event|Artemether-lumefantrine Primaquine 14days|"mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: 14 days"
36421|NCT02389374|E2|Reported Event|Artemether-lumefantrine Primaquine 1day|"P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: single dose"
36422|NCT02389374|E1|Reported Event|Chloroquine Primaquine 14days|"P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines~chloroquine: standard dose~Primaquine: 14 days"
36423|NCT02389361|B3|Baseline|Total|Total of all reporting groups
36424|NCT02389361|B2|Baseline|Group PT|"Postoperative Analgesia with Paracetamol-Tramadol~Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol"
36425|NCT02389361|B1|Baseline|Group Z|"Postoperative Analgesia with Zaldiar~Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)"
36426|NCT02389361|P2|Participant Flow|Group PT|"Postoperative Analgesia with Paracetamol-Tramadol~Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol"
36427|NCT02389361|P1|Participant Flow|Group Z|"Postoperative Analgesia with Zaldiar~Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)"
36428|NCT02389361|O2|Outcome|Group PT|"Postoperative Analgesia with Paracetamol-Tramadol~Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol"
36429|NCT02389361|O1|Outcome|Group Z|"Postoperative Analgesia with Zaldiar~Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)"
36430|NCT02389361|E2|Reported Event|Group PT|"Postoperative Analgesia with Paracetamol-Tramadol~Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol"
36431|NCT02389361|E1|Reported Event|Group Z|"Postoperative Analgesia with Zaldiar~Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)"
36432|NCT02389088|B1|Baseline|Phase I|9 PCOS women
36433|NCT02389088|P1|Participant Flow|Phase I - All Study Participants|"9 PCOS women will be studied. On study day one, r-FSH will be administered I.V. at a dose of 150 IU (FSH stimulation test). Blood samples will be obtained before and after FSH administration. After the FSH stimulation test, each subject will receive an I.M. injection of Lupron 3.75 mg. This dose has a duration effect of one month.~The FSH stimulation test will be repeated, as described above, at 5 weeks (early resumption of ovarian function) and 6 weeks (moderate resumption of ovarian function)."
36434|NCT02389088|O10|Outcome|Phase II - Week 6 - 24 Hours|
36435|NCT02389088|O9|Outcome|Phase II - Week 6 - 0 Hours|
36436|NCT02389088|O8|Outcome|Phase II - Week 5 - 24 Hours|
36474|NCT02389088|E2|Reported Event|Phase II|"Women that participated in Phase I will be studied again after a washout of 2 months. On study day one, an FSH stimulation test will be performed as described above.~After the FSH stimulation test, each subject will receive an I.M. injection of Lupron 3.75 mg. This dose has a duration effect of one month. Four weeks after administration of Lupron, each subject will receive Letrozole 5mg for 14 days. The FSH stimulation test will be repeated at 5 weeks (early resumption of ovarian function) and 6 weeks (moderate resumption of ovarian function).~Letrozole: In Phase II, letrozole, 5 mg/day, will be given for 14 days"
36475|NCT02389088|E1|Reported Event|Phase I|"9 PCOS women will be studied. On study day one, r-FSH will be administered I.V. at a dose of 150 IU (FSH stimulation test). Blood samples will be obtained before and after FSH administration. After the FSH stimulation test, each subject will receive an I.M. injection of Lupron 3.75 mg. This dose has a duration effect of one month.~The FSH stimulation test will be repeated, as described above, at 5 weeks (early resumption of ovarian function) and 6 weeks (moderate resumption of ovarian function)."
36476|NCT02388815|B1|Baseline|FreeStyle Libre Flash Glucose Monitoring System|"FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System masked for 14 days.~During these 14 days subjects will be asked to perform 4 blood glucose tests (meals time and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
36477|NCT02388815|P1|Participant Flow|FreeStyle Libre Flash Glucose Monitoring System|"FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System masked for 14 days.~During these 14 days subjects will be asked to perform 4 blood glucose tests (meals time and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
36478|NCT02388815|O1|Outcome|FreeStyle Libre Flash Glucose Monitoring System|"FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System masked for 14 days.~During these 14 days subjects will be asked to perform 4 blood glucose tests (meals time and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
36479|NCT02388815|E1|Reported Event|FreeStyle Libre Flash Glucose Monitoring System|"FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System masked for 14 days.~During these 14 days subjects will be asked to perform 4 blood glucose tests (meals time and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
36480|NCT02388776|B1|Baseline|ROTEM|"Clinical burn ICU Inpatients receiving blood draws for ROTEM analysis and fibrinogen levels.~ROTEM: A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve."
36481|NCT02388776|P1|Participant Flow|ROTEM|"Clinical burn ICU Inpatients receiving blood draws for ROTEM analysis and fibrinogen levels.~ROTEM: A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve."
36482|NCT02388776|O1|Outcome|ROTEM|"Clinical burn ICU Inpatients receiving blood draws for ROTEM analysis and fibrinogen levels.~ROTEM: A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve."
36483|NCT02388776|O1|Outcome|Active Arm|"Clinical burn ICU Inpatients receiving blood draws for ROTEM analysis and fibrinogen levels.~ROTEM: A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve."
36484|NCT02388776|E1|Reported Event|Active Arm|"Clinical burn ICU Inpatients receiving blood draws for ROTEM analysis and fibrinogen levels.~ROTEM: A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve."
36485|NCT02388763|B1|Baseline|Overall|Habitual contact lenses worn first, followed by stenfilcon A contact lenses and narafilcon A contact lenses in Periods 1 and 2 as randomized. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
36486|NCT02388763|P2|Participant Flow|Habitual, 1DAVTE, MyDay|Habitual contact lenses worn first, followed by narafilcon A contact lenses in Period 1 and stenfilcon A contact lenses in Period 2. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
36487|NCT02388763|P1|Participant Flow|Habitual, MyDay, 1DAVTE|Habitual contact lenses worn first, followed by stenfilcon A contact lenses in Period 1 and narafilcon A contact lenses in Period 2. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
39999|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
36492|NCT02388763|E5|Reported Event|1DAVTE|Narafilcon A contact lenses worn for 10 days during Period 1 or 2 as randomized
36493|NCT02388763|E4|Reported Event|MyDay|Stenfilcon A contact lenses worn for 10 days during Period 1 or 2 as randomized
36494|NCT02388763|E3|Reported Event|Clariti 1-Day|Somofilcon A contact lenses per subject's habitual prescription worn for 10 days prior to Period 1
36495|NCT02388763|E2|Reported Event|Dailies Total 1|Delefilcon A contact lenses per subject's habitual prescription worn for 10 days prior to Period 1
36496|NCT02388763|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
36497|NCT02388347|B6|Baseline|Total|Total of all reporting groups
36498|NCT02388347|B5|Baseline|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
36499|NCT02388347|B4|Baseline|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
36500|NCT02388347|B3|Baseline|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
36501|NCT02388347|B2|Baseline|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
36502|NCT02388347|B1|Baseline|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
36503|NCT02388347|P5|Participant Flow|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
36504|NCT02388347|P4|Participant Flow|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
36505|NCT02388347|P3|Participant Flow|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
36506|NCT02388347|P2|Participant Flow|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
36507|NCT02388347|P1|Participant Flow|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
36508|NCT02388347|O5|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
36509|NCT02388347|O4|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
36510|NCT02388347|O3|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
36511|NCT02388347|O2|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
36512|NCT02388347|O1|Outcome|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
36513|NCT02388347|O4|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
36514|NCT02388347|O3|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
36515|NCT02388347|O2|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
36516|NCT02388347|O1|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
36517|NCT02388347|O4|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
36518|NCT02388347|O3|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
36519|NCT02388347|O2|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
36520|NCT02388347|O1|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
36521|NCT02388347|O4|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
36522|NCT02388347|O3|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
36523|NCT02388347|O2|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
36524|NCT02388347|O1|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
36525|NCT02388347|O4|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
36526|NCT02388347|O3|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
36527|NCT02388347|O2|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
36528|NCT02388347|O1|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
36529|NCT02388347|O4|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
36530|NCT02388347|O3|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
36531|NCT02388347|O2|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
36532|NCT02388347|O1|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
36533|NCT02388347|O4|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
36534|NCT02388347|O3|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
36535|NCT02388347|O2|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
36536|NCT02388347|O1|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
36537|NCT02388347|O4|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
36538|NCT02388347|O3|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
36539|NCT02388347|O2|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
36540|NCT02388347|O1|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
40000|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
36541|NCT02388347|O5|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
36542|NCT02388347|O4|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
36543|NCT02388347|O3|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
36544|NCT02388347|O2|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
36545|NCT02388347|O1|Outcome|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
36546|NCT02388347|O5|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
36547|NCT02388347|O4|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
36548|NCT02388347|O3|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
36549|NCT02388347|O2|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
36550|NCT02388347|O1|Outcome|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
36551|NCT02388347|O5|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
36552|NCT02388347|O4|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
36553|NCT02388347|O3|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
36554|NCT02388347|O2|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
36555|NCT02388347|O1|Outcome|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
36556|NCT02388347|O5|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
36557|NCT02388347|O4|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
36558|NCT02388347|O3|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
36559|NCT02388347|O2|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
36560|NCT02388347|O1|Outcome|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
36561|NCT02388347|O5|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
36562|NCT02388347|O4|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
36563|NCT02388347|O3|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
36564|NCT02388347|O2|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
36565|NCT02388347|O1|Outcome|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
36566|NCT02388347|E5|Reported Event|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
36567|NCT02388347|E4|Reported Event|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
36568|NCT02388347|E3|Reported Event|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
36569|NCT02388347|E2|Reported Event|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
36570|NCT02388347|E1|Reported Event|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
36571|NCT02388321|B3|Baseline|Total|Total of all reporting groups
36572|NCT02388321|B2|Baseline|Fentanyl|"intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.~Fentanyl: intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department."
36573|NCT02388321|B1|Baseline|Ketamine|"intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.~Ketamine: intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department."
36574|NCT02388321|P2|Participant Flow|Fentanyl|"intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.~Fentanyl: intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department."
36575|NCT02388321|P1|Participant Flow|Ketamine|"intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.~Ketamine: intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department."
36576|NCT02388321|O2|Outcome|Fentanyl|"intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.~Fentanyl: intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department."
36577|NCT02388321|O1|Outcome|Ketamine|"intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.~Ketamine: intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department."
36578|NCT02388321|O2|Outcome|Fentanyl|"intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.~Fentanyl: intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department."
36579|NCT02388321|O1|Outcome|Ketamine|"intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.~Ketamine: intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department."
36580|NCT02388321|E2|Reported Event|Fentanyl|"intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.~Fentanyl: intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department."
36635|NCT02388269|E2|Reported Event|gammaCore®-G Sham FD|"Sham Comparator: sham gammaCore device~gammaCore sham stimulation treatment"
36581|NCT02388321|E1|Reported Event|Ketamine|"intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.~Ketamine: intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department."
36582|NCT02388295|B4|Baseline|Total|Total of all reporting groups
36583|NCT02388295|B3|Baseline|AZD3241 600 mg|AZD3241 600 mg dosed twice daily
36584|NCT02388295|B2|Baseline|AZD3241 300 mg|AZD3241 300 mg dosed twice daily
36585|NCT02388295|B1|Baseline|Placebo|Placebo to match AZD3241 dosed twice daily
36586|NCT02388295|P3|Participant Flow|AZD3241 600 mg|AZD3241 600 mg dosed twice daily
36587|NCT02388295|P2|Participant Flow|AZD3241 300 mg|AZD3241 300 mg dosed twice daily
36588|NCT02388295|P1|Participant Flow|Placebo|Placebo to match AZD3241 dosed twice daily
36589|NCT02388295|O3|Outcome|AZD3241 600 mg|AZD3241 600 mg dosed twice daily
36590|NCT02388295|O2|Outcome|AZD3241 300 mg|AZD3241 300 mg dosed twice daily
36591|NCT02388295|O1|Outcome|Placebo|Placebo to match AZD3241 dosed twice daily
36592|NCT02388295|O3|Outcome|AZD3241 600 mg|AZD3241 600 mg dosed twice daily
36593|NCT02388295|O2|Outcome|AZD3241 300 mg|AZD3241 300 mg dosed twice daily
36594|NCT02388295|O1|Outcome|Placebo|Placebo to match AZD3241 dosed twice daily
36595|NCT02388295|O3|Outcome|AZD3241 600 mg|AZD3241 600 mg dosed twice daily
36596|NCT02388295|O2|Outcome|AZD3241 300 mg|AZD3241 300 mg dosed twice daily
36597|NCT02388295|O1|Outcome|Placebo|Placebo to match AZD3241 dosed twice daily
36598|NCT02388295|E3|Reported Event|AZD3241 600 mg|AZD3241 600 mg dosed twice daily
36599|NCT02388295|E2|Reported Event|AZD3241 300 mg|AZD3241 300 mg dosed twice daily
36600|NCT02388295|E1|Reported Event|Placebo|Placebo to match AZD3241 dosed twice daily
36601|NCT02388269|B5|Baseline|Total|Total of all reporting groups
36602|NCT02388269|B4|Baseline|gammaCore®-G Sham Irritale Bowel Syndrome|"Sham Comparator: sham gammaCore device~gammaCore sham stimulation treatment"
36603|NCT02388269|B3|Baseline|gammaCore®-G Irritable Bowel Syndrome|"Active Comparator: Active gammaCore device~gammaCore active stimulation treatment"
36604|NCT02388269|B2|Baseline|gammaCore®-G Sham Functional Dyspepsia|"Sham Comparator: sham gammaCore device~gammaCore sham stimulation treatment"
36605|NCT02388269|B1|Baseline|gammaCore®-G Functional Dyspepsia|"Active Comparator: Active gammaCore device~gammaCore active stimulation treatment"
36606|NCT02388269|P3|Participant Flow|Not Randomised|Subjects that were not randomised, i.e. screen failures
36607|NCT02388269|P2|Participant Flow|gammaCore®-G Sham|"Sham Comparator: sham gammaCore device~gammaCore sham stimulation treatment"
36608|NCT02388269|P1|Participant Flow|gammaCore®-G|"Active Comparator: Active gammaCore device~gammaCore active stimulation treatment"
36609|NCT02388269|O2|Outcome|gammaCore®-G Sham|"Sham Comparator: sham gammaCore device~gammaCore sham stimulation treatment - Functional Dyspepsia Cohort"
36610|NCT02388269|O1|Outcome|gammaCore®-G|"Active Comparator: Active gammaCore device~gammaCore active stimulation treatment - Functional Dyspepsia Cohort"
36611|NCT02388269|O6|Outcome|Total Sham Gammacore|Total Sham gammacore - Functional Dyspepsia + Irritable Bowel Syndrome
36612|NCT02388269|O5|Outcome|Total Active Gammacore|Total Active gammacore - Functional Dyspepsia + Irritable Bowel Syndrome
36613|NCT02388269|O4|Outcome|Irritable Bowel Syndrome Cohort Sham|Irritable Bowel Syndrome Cohort - Sham gammacore
36614|NCT02388269|O3|Outcome|Irritable Bowel Syndrome Cohort|Irritable Bowel Syndrome Cohort - Active gammacore
36615|NCT02388269|O2|Outcome|Functional Dyspepsia Cohort Sham|Functional Dyspepsia Cohort - Sham gammacore
36616|NCT02388269|O1|Outcome|Functional Dyspepsia Cohort Active|Functional Dyspepsia Cohort - Active gammacore
36617|NCT02388269|O2|Outcome|gammaCore®-G Sham|"Sham Comparator: sham gammaCore device~gammaCore sham stimulation treatment"
36618|NCT02388269|O1|Outcome|gammaCore®-G|"Active Comparator: Active gammaCore device~gammaCore active stimulation treatment"
36619|NCT02388269|O4|Outcome|gammaCore®-G Sham IBS|"Sham Comparator: sham gammaCore device~gammaCore sham stimulation treatment"
36620|NCT02388269|O3|Outcome|gammaCore®-G IBS|"Active Comparator: Active gammaCore device~gammaCore active stimulation treatment"
36621|NCT02388269|O2|Outcome|gammaCore®-G Sham FD|"Sham Comparator: sham gammaCore device~gammaCore sham stimulation treatment"
36622|NCT02388269|O1|Outcome|gammaCore®-G FD|"Active Comparator: Active gammaCore device~gammaCore active stimulation treatment"
36623|NCT02388269|O4|Outcome|Interference With Normal Activities - SHAM|Sham Comparator: sham gammaCore device How often has this symptom interfered with your normal activities over the last 2 months?
36624|NCT02388269|O3|Outcome|Interference With Normal Activities - ACTIVE|Active Comparator: Active gammaCore device How often has this symptom interfered with your normal activities over the last 2 months?
36625|NCT02388269|O2|Outcome|Frequency of Symptoms Over the Last 2 Months - SHAM|Sham Comparator: sham gammaCore device How often have you had this symptom over the last 2 months?
36626|NCT02388269|O1|Outcome|Frequency of Symptoms Over Last 2 Months - ACTIVE|Active Comparator: Active gammaCore device How often have you had this symptom over the last 2 months?
36627|NCT02388269|O4|Outcome|gammaCore®-G Sham IBS|"Sham Comparator: sham gammaCore device~gammaCore sham stimulation treatment"
36628|NCT02388269|O3|Outcome|gammaCore®-G IBS|"Active Comparator: Active gammaCore device~gammaCore active stimulation treatment"
36629|NCT02388269|O2|Outcome|gammaCore®-G Sham FD|"Sham Comparator: sham gammaCore device~gammaCore sham stimulation treatment"
36630|NCT02388269|O1|Outcome|gammaCore®-G FD|"Active Comparator: Active gammaCore device~gammaCore active stimulation treatment"
36631|NCT02388269|O2|Outcome|gammaCore®-G Sham|"Sham Comparator: sham gammaCore device~gammaCore sham stimulation treatment"
36632|NCT02388269|O1|Outcome|gammaCore®-G|"Active Comparator: Active gammaCore device~gammaCore active stimulation treatment"
36633|NCT02388269|E4|Reported Event|gammaCore®-G Sham IBS|"Sham Comparator: sham gammaCore device~gammaCore sham stimulation treatment"
36634|NCT02388269|E3|Reported Event|gammaCore®-G IBS|"Active Comparator: Active gammaCore device~gammaCore active stimulation treatment"
36765|NCT02387554|B5|Baseline|Total|Total of all reporting groups
36636|NCT02388269|E1|Reported Event|gammaCore®-G FD|"Active Comparator: Active gammaCore device~gammaCore active stimulation treatment"
36637|NCT02388191|B3|Baseline|Total|Total of all reporting groups
36638|NCT02388191|B2|Baseline|Placebo|"Placebo~Placebo tablet"
36639|NCT02388191|B1|Baseline|Naproxen Sodium|"550 mg naproxen sodium~Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
36640|NCT02388191|P2|Participant Flow|Placebo|"Placebo~Placebo tablet"
36641|NCT02388191|P1|Participant Flow|Naproxen Sodium|"550 mg naproxen sodium~Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
36642|NCT02388191|O2|Outcome|Placebo|"Placebo~Placebo tablet"
36643|NCT02388191|O1|Outcome|Naproxen Sodium|"550 mg naproxen sodium~Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
36644|NCT02388191|O2|Outcome|Placebo|"Placebo~Placebo tablet"
36645|NCT02388191|O1|Outcome|Naproxen Sodium|"550 mg naproxen sodium~Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
36646|NCT02388191|O2|Outcome|Placebo|"Placebo~Placebo tablet"
36647|NCT02388191|O1|Outcome|Naproxen Sodium|"550 mg naproxen sodium~Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
36648|NCT02388191|O2|Outcome|Placebo|"Placebo~Placebo tablet"
36649|NCT02388191|O1|Outcome|Naproxen Sodium|"550 mg naproxen sodium~Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
36650|NCT02388191|O2|Outcome|Placebo|"Placebo~Placebo tablet"
36651|NCT02388191|O1|Outcome|Naproxen Sodium|"550 mg naproxen sodium~Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
36652|NCT02388191|E2|Reported Event|Placebo|"Placebo~Placebo tablet"
36653|NCT02388191|E1|Reported Event|Naproxen Sodium|"550 mg naproxen sodium~Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
36654|NCT02388074|B1|Baseline|CyPath® Assay of Deep-Lung Sputum Sample|"Deep-lung sputum was obtained from healthy individuals who had no known lung disease, was labeled with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.~CyPath®: CyPath® diagnostic assay for the early detection of lung cancer using sputum"
36655|NCT02388074|P1|Participant Flow|CyPath® Assay of Deep-Lung Sputum Sample|"Deep-lung sputum was obtained from healthy individuals who had no known lung disease, was labeled with TCPP and evaluated to detect red fluorescent [i.e., cancer] cells (RFCs) from deep-lung sputum samples.~CyPath®: CyPath® diagnostic assay for the early detection of lung cancer using sputum"
36656|NCT02388074|O1|Outcome|CyPath® Assay of Deep-Lung Sputum Sample|"Deep-lung sputum was obtained from healthy individuals who had no known lung disease, was labeled with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.~CyPath®: CyPath® diagnostic assay for the early detection of lung cancer using sputum"
36657|NCT02388074|E1|Reported Event|CyPath® Assay of Deep-Lung Sputum Sample|"Deep-lung sputum was obtained from healthy individuals who had no known lung disease, was labeled with TCPP and evaluated to detect red fluorescent [i.e., cancer] cells (RFCs) from deep-lung sputum samples.~CyPath®: CyPath® diagnostic assay for the early detection of lung cancer using sputum"
36658|NCT02387996|B1|Baseline|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
36659|NCT02387996|P1|Participant Flow|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
36660|NCT02387996|O1|Outcome|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
36661|NCT02387996|O1|Outcome|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
36662|NCT02387996|O1|Outcome|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
36663|NCT02387996|O1|Outcome|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
36664|NCT02387996|O1|Outcome|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
36665|NCT02387996|O1|Outcome|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
36666|NCT02387996|O1|Outcome|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
36667|NCT02387996|O1|Outcome|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
36668|NCT02387996|E1|Reported Event|NIVOLUMAB 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
36669|NCT02387983|B1|Baseline|Posaconazole|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
36670|NCT02387983|P1|Participant Flow|Posaconazole|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
36671|NCT02387983|O1|Outcome|Posaconazole|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
36672|NCT02387983|O1|Outcome|Posaconazole|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
36673|NCT02387983|O1|Outcome|Posaconazole|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
36674|NCT02387983|O1|Outcome|Posaconazole|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
36766|NCT02387554|B4|Baseline|Sequence 4|Period 1 : ALC Period 2 : A Period 3 : C Period 4 : L
36675|NCT02387983|O1|Outcome|Posaconazole|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
36676|NCT02387983|O1|Outcome|Posaconazole|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
36677|NCT02387983|O1|Outcome|Posaconazole|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
36678|NCT02387983|O1|Outcome|Posaconazole|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
36679|NCT02387983|O1|Outcome|Posaconazole|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
36680|NCT02387983|E1|Reported Event|MK-5592|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse group) underwent intensive and sparse PK sampling on Days 1 and 8; the next 45 participants (Sparse group) underwent PK sampling on Day 8 only.
36681|NCT02387801|B3|Baseline|Total|Total of all reporting groups
36682|NCT02387801|B2|Baseline|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
36683|NCT02387801|B1|Baseline|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
36684|NCT02387801|P2|Participant Flow|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once (Q4W) every 4 weeks through week 44.
36685|NCT02387801|P1|Participant Flow|Ixekizumab Q2W|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once (Q2W) every 2 weeks through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
36686|NCT02387801|O2|Outcome|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
36687|NCT02387801|O1|Outcome|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
36688|NCT02387801|O2|Outcome|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
36689|NCT02387801|O1|Outcome|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
36690|NCT02387801|O2|Outcome|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
36691|NCT02387801|O1|Outcome|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
36692|NCT02387801|O2|Outcome|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
36693|NCT02387801|O1|Outcome|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
36694|NCT02387801|O2|Outcome|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
36695|NCT02387801|O1|Outcome|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
36696|NCT02387801|O2|Outcome|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
36697|NCT02387801|O1|Outcome|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
36698|NCT02387801|E4|Reported Event|Ixekizumab 80 mg Q4W Post-treatment|All participants receiving at least one dose of ixekizumab entered the post treatment follow-up period for a minimum of 12 weeks.
36699|NCT02387801|E3|Reported Event|Ixekizumab 80 mg Q4W Maintenance|After week 12 all participants are given 80 mg ixekizumab as a single SC injection once Q4W through week 44.
36700|NCT02387801|E2|Reported Event|Ixekizumab Q4W Induction Dosing Period|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
36701|NCT02387801|E1|Reported Event|Ixekizumab Q2W Induction Dosing Period|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
36767|NCT02387554|B3|Baseline|Sequence 3|Period 1 : C Period 2 : ALC Period 3 : L Period 4 : A
36702|NCT02387749|B1|Baseline|Mesenchymal Stem Cells Transfusion in DPN Patients|This study was conducted on 10 patients with Diabetic peripheral neuropathy (DPN), 4 females and 6 males
36703|NCT02387749|P1|Participant Flow|Mesenchymal Stem Cells Transfusion in Diabetic Neuropathy|collection: bone marrow biopsy from iliac crest. Separation of cells:The bone marrow aspirate will be diluted at a ratio of 6:1 with phosphate buffer saline (PBS) with 2 ml EDTA (30 ml BM aspirate+ 5 ml PBS/EDTA buffer). The MNCs will be separated under aseptic conditions using a Ficoll. Hypaque desity gradient by centrifugation at 1800 rpm for 20 min then the MNCs will be plated in 40 ml alpha-modi-field Eagle's medium (αMEM), serum free media; mesencult(Mesenchymal stem cell culture),penicillin (100 U/ml),streptomycin(10 mg/ml),0.5 ml amphotericin B(all from Gibco BRL) and 10 ng/ml basic fibroblast growth factor (b-FGF) (R&D system, Minneapolis, MN) and will be incubated at 37 c in a humidified atmosphere containing 5% CO2.after one day,non adherent cells will be cultured in the presence of Mesenchymal media for 3 weeks changed every 1 week. After reaching 80% confluence the MSCs will be placed in 10 ml saline and will be infused intravenously. on 2 sessions to the same patient
36704|NCT02387749|O1|Outcome|HA1C Measurment Before and Afterr Stem Cell|as a cumulative effect of patient control we measured HA1C at zero level and 90 days after stem cell transfusion in %
36705|NCT02387749|O1|Outcome|Blood Tests Measured Before and After Stem Cell Transfusion|Plasma biochemical blood measurements will be determined by standard laboratory procedures in the central lab at clinical pathology department, Kasr Alaini hospital) Fasting blood glucose level, 2 hours postprandial.
36706|NCT02387749|O1|Outcome|Nerve Conduction Amplitudes of Nerves|"nerve conduction amplitudes of nerves examined measured in Upper limbs and Lower limbs nerves,motor and sensory lower limb motor nerves: tibial and common peroneal, lower limb sensory nerve : sural nerve.~upper limb motor nerve: ulnar nerve motor , upper limb sensory nerve: ulnar nerve sensory data measured at zero (before stem cell transfusion) and 90 days after stem cell transfusion"
36707|NCT02387749|O1|Outcome|Nerve Conduction Latency of Nerves|nerve conduction latency of nerves examined measured in Upper limbs and Lower limbs nerves,motor and sensory lower limb motor nerves: tibial and common peroneal lower limb sensory nerve : sural nerve upper limb motor nerve: ulnar nerve upper limb sensory nerve: ulnar nerve data measured at zero (before stem cell transfusion) and 90 days after stem cell transfusion
36708|NCT02387749|O1|Outcome|Nerve Conduction Velocities of Nerves|"nerve conduction velocities of nerves examined measured in Upper limbs and Lower limbs nerves,motor and sensory~lower limb motor nerves: tibial and common peroneal lower limb sensory nerve : sural nerve~upper limb motor nerve: ulnar nerve upper limb sensory nerve: ulnar nerve~data measured at zero (before stem cell transfusion) and 90 days after stem cell transfusion"
36709|NCT02387749|O1|Outcome|Measurement of b-FGF and v- EGF MEASURED BY ELISA|measurement of b-FGF and v- EGF MEASURED BY ELISA before (at zero), and after at (7 days, 90) days after stem cell transfusion to measure the effect of stem cell and its role in nerve regeneration
36710|NCT02387749|E1|Reported Event|Mesenchymal Stem Cells Transfusion in Diabetic Neuropathy|collection: bone marrow biopsy from iliac crest. Separation of cells:The bone marrow aspirate will be diluted at a ratio of 6:1 with phosphate buffer saline (PBS) with 2 ml EDTA (30 ml BM aspirate+ 5 ml PBS/EDTA buffer). The MNCs will be separated under aseptic conditions using a Ficoll. Hypaque desity gradient by centrifugation at 1800 rpm for 20 min then the MNCs will be plated in 40 ml alpha-modi-field Eagle's medium (αMEM), serum free media; mesencult(Mesenchymal stem cell culture),penicillin (100 U/ml),streptomycin(10 mg/ml),0.5 ml amphotericin B(all from Gibco BRL) and 10 ng/ml basic fibroblast growth factor (b-FGF) (R&D system, Minneapolis, MN) and will be incubated at 37 c in a humidified atmosphere containing 5% CO2.after one day,non adherent cells will be cultured in the presence of Mesenchymal media for 3 weeks changed every 1 week. After reaching 80% confluence the MSCs will be placed in 10 ml saline and will be infused intravenously. on 2 sessions to the same patient
36711|NCT02387710|B1|Baseline|All Analyzed Participants|All patients who were randomized, completed both study nights and were included in the analysis
36712|NCT02387710|P2|Participant Flow|Placebo First, Tiagabine Second|Placebo-matching tiagabine administered at normal sleep timeon first study night, then a 1-week non-treatment, then tiagabine 12 mg administered at normal sleep time on second study night
36713|NCT02387710|P1|Participant Flow|Tiagabine First, Placebo Second|Tiagabine 12 mg administered at normal sleep time on first study night, then a 1-week non-treatment period, then placebo-matching tiagabine administered at normal sleep time on second study night.
36714|NCT02387710|O2|Outcome|Placebo|Placebo administered at sleep time on the first or the second study night
36715|NCT02387710|O1|Outcome|Tiagabine|Tiagabine 12 mg administered at sleep time on the first or the second study night
36716|NCT02387710|O2|Outcome|Placebo|Placebo administered at sleep time on the first or second study night
36717|NCT02387710|O1|Outcome|Tiagabine|Tiagabine 12 mg administered at sleep time on the first or second study night
36718|NCT02387710|O2|Outcome|Placebo|Placebo administered at sleep time on the first or second study night
36719|NCT02387710|O1|Outcome|Tiagabine|Tiagabine 12 mg administered at sleep time on the first or second study night
36720|NCT02387710|E2|Reported Event|Placebo|Placebo administered at sleep time on the first or second study night
36721|NCT02387710|E1|Reported Event|Tiagabine|Tiagabine 12 mg administered at sleep time on the first or second study night
36722|NCT02387580|B7|Baseline|Total|Total of all reporting groups
36723|NCT02387580|B6|Baseline|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume ) and 960 mg (3 × 320 mg) PQP tablets
36724|NCT02387580|B5|Baseline|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36725|NCT02387580|B4|Baseline|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36726|NCT02387580|B3|Baseline|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36727|NCT02387580|B2|Baseline|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36728|NCT02387580|B1|Baseline|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36729|NCT02387580|P6|Participant Flow|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36730|NCT02387580|P5|Participant Flow|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36731|NCT02387580|P4|Participant Flow|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36732|NCT02387580|P3|Participant Flow|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36733|NCT02387580|P2|Participant Flow|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36734|NCT02387580|P1|Participant Flow|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36735|NCT02387580|O6|Outcome|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36736|NCT02387580|O5|Outcome|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36737|NCT02387580|O4|Outcome|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36738|NCT02387580|O3|Outcome|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36739|NCT02387580|O2|Outcome|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36740|NCT02387580|O1|Outcome|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36741|NCT02387580|O6|Outcome|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36742|NCT02387580|O5|Outcome|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36743|NCT02387580|O4|Outcome|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36744|NCT02387580|O3|Outcome|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36745|NCT02387580|O2|Outcome|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36746|NCT02387580|O1|Outcome|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36747|NCT02387580|O6|Outcome|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36748|NCT02387580|O5|Outcome|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36749|NCT02387580|O4|Outcome|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36750|NCT02387580|O3|Outcome|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36751|NCT02387580|O2|Outcome|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36752|NCT02387580|O1|Outcome|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36753|NCT02387580|O6|Outcome|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume ) and 960 mg (3 × 320 mg) PQP tablets
36754|NCT02387580|O5|Outcome|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36755|NCT02387580|O4|Outcome|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36756|NCT02387580|O3|Outcome|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36757|NCT02387580|O2|Outcome|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36758|NCT02387580|O1|Outcome|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36759|NCT02387580|E6|Reported Event|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36760|NCT02387580|E5|Reported Event|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36761|NCT02387580|E4|Reported Event|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36762|NCT02387580|E3|Reported Event|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36763|NCT02387580|E2|Reported Event|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36764|NCT02387580|E1|Reported Event|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
36770|NCT02387554|P4|Participant Flow|Sequence 4|Period 1 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose) Period 2 : A (Amlodipine 10mg PO single dose) Period 3 : C (Chlorthalidone 25mg PO single dose) Period 4 : L (Losartan 100mg PO single dose)
36771|NCT02387554|P3|Participant Flow|Sequence 3|Period 1 : C (Chlorthalidone 25mg PO single dose) Period 2 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose) Period 3 : L (Losartan 100mg PO single dose) Period 4 : A (Amlodipine 10mg PO single dose)
36772|NCT02387554|P2|Participant Flow|Sequence 2|Period 1 : L (Losartan 100mg PO single dose) Period 2 : C (Chlorthalidone 25mg PO single dose) Period 3 : A (Amlodipine 10mg PO single dose) Period 4 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose)
36773|NCT02387554|P1|Participant Flow|Sequence 1|Period 1 : A (Amlodipine 10mg PO single dose) Period 2 : L (Losartan 100mg PO single dose) Period 3 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose) Period 4 : C (Chlorthalidone 25mg PO single dose)
36774|NCT02387554|O4|Outcome|EXP3174|EXP3174(losartan active metabolite) ratio in single or combination
36775|NCT02387554|O3|Outcome|HGP1405|HGP1405(chlorthalidone) ratio in single or combination
36776|NCT02387554|O2|Outcome|HGP0608|HGP0608(losartan) ratio in single or combination
36777|NCT02387554|O1|Outcome|HGP0904|HGP0904(amlodipine) ratio in single or combination
36778|NCT02387554|E4|Reported Event|HGP0904+HGP0608+HGP1405|"amlodipine + losartan + chlorthalidone~HGP0904~HGP0608~HGP1405"
36779|NCT02387554|E3|Reported Event|HGP1405|"chlorthalidone~HGP1405"
36780|NCT02387554|E2|Reported Event|HGP0608|"losartan~HGP0608"
36781|NCT02387554|E1|Reported Event|HGP0904|"amlodipine~HGP0904"
36782|NCT02387502|B4|Baseline|Total|Total of all reporting groups
36783|NCT02387502|B3|Baseline|Intubation With Airtraq Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed."
36784|NCT02387502|B2|Baseline|Intubation With MacCoy Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated."
36785|NCT02387502|B1|Baseline|Intubation With Macintosh Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated."
36786|NCT02387502|P3|Participant Flow|Intubation With Airtraq Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed."
36787|NCT02387502|P2|Participant Flow|Intubation With MacCoy Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated."
36788|NCT02387502|P1|Participant Flow|Intubation With Macintosh Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated."
36789|NCT02387502|O3|Outcome|Intubation With Airtraq Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed."
36815|NCT02387476|O1|Outcome|"FRESCA Mask First Night | CPAP Second Night"|"First night using FRESCA nasal mask and second night using CPAP~FRESCA Nasal Mask: FRESCA nasal mask"
40001|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
36790|NCT02387502|O2|Outcome|Intubation With MacCoy Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated."
36791|NCT02387502|O1|Outcome|Intubation With Macintosh Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated."
36792|NCT02387502|E3|Reported Event|Intubation With Airtraq Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed."
36793|NCT02387502|E2|Reported Event|Intubation With MacCoy Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated."
36794|NCT02387502|E1|Reported Event|Intubation With Macintosh Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated."
36795|NCT02387476|B3|Baseline|Total|Total of all reporting groups
36796|NCT02387476|B2|Baseline|CPAP Mask First and CPAP Mask Second|One night using patient providing CPAP nasal mask and second night using FRESCA mask
36797|NCT02387476|B1|Baseline|FRESCA Mask First CPAP Mask Second|One night using FRESCA nasal mask and the second night using patient provided CPAP
36798|NCT02387476|P2|Participant Flow|CPAP Mask - FRESCA Mask Second|"One night using CPAP nasal mask and then second night using FRESCA nasal mask~CPAP Nasal Mask: CPAP nasal pillow and nasal mask"
36799|NCT02387476|P1|Participant Flow|FRESCA Mask First - CPAP Second|"First night using FRESCA nasal mask and second night using CPAP~FRESCA Nasal Mask: FRESCA nasal mask"
36800|NCT02387476|O2|Outcome|"CPAP Mask First Night | FRESCA Mask Second Night"|"One night using CPAP nasal mask and then second night using FRESCA nasal mask~CPAP Nasal Mask: CPAP nasal pillow and nasal mask"
36801|NCT02387476|O1|Outcome|"FRESCA Mask First Night | CPAP Second Night"|"First night using FRESCA nasal mask and second night using CPAP~FRESCA Nasal Mask: FRESCA nasal mask"
36802|NCT02387476|O2|Outcome|"CPAP Mask First Night | FRESCA Mask Second Night"|"One night using CPAP nasal mask and then second night using FRESCA nasal mask~CPAP Nasal Mask: CPAP nasal pillow and nasal mask"
36803|NCT02387476|O1|Outcome|"FRESCA Mask First Night | CPAP Second Night"|"First night using FRESCA nasal mask and second night using CPAP~FRESCA Nasal Mask: FRESCA nasal mask"
36804|NCT02387476|O2|Outcome|"CPAP Mask First Night | FRESCA Mask Second Night"|"One night using CPAP nasal mask and then second night using FRESCA nasal mask~CPAP Nasal Mask: CPAP nasal pillow and nasal mask"
36805|NCT02387476|O1|Outcome|"FRESCA Mask First Night | CPAP Second Night"|"First night using FRESCA nasal mask and second night using CPAP~FRESCA Nasal Mask: FRESCA nasal mask"
36806|NCT02387476|O2|Outcome|"CPAP Mask First Night | FRESCA Mask Second Night"|"One night using CPAP nasal mask and then second night using FRESCA nasal mask~CPAP Nasal Mask: CPAP nasal pillow and nasal mask"
36807|NCT02387476|O1|Outcome|"FRESCA Mask First Night | CPAP Second Night"|"First night using FRESCA nasal mask and second night using CPAP~FRESCA Nasal Mask: FRESCA nasal mask"
36808|NCT02387476|O2|Outcome|CPAP Mask First Night|"One night using CPAP nasal mask and then second night using FRESCA nasal mask~CPAP Nasal Mask: CPAP nasal pillow and nasal mask"
36809|NCT02387476|O1|Outcome|FRESCA Mask First Night|"First night using FRESCA nasal mask and second night using CPAP~FRESCA Nasal Mask: FRESCA nasal mask"
36810|NCT02387476|O2|Outcome|"CPAP Mask First Night | FRESCA Mask Second Night"|"One night using CPAP nasal mask and then second night using FRESCA nasal mask~CPAP Nasal Mask: CPAP nasal pillow and nasal mask"
36811|NCT02387476|O1|Outcome|"FRESCA Mask First Night | CPAP Second Night"|"First night using FRESCA nasal mask and second night using CPAP~FRESCA Nasal Mask: FRESCA nasal mask"
36812|NCT02387476|O2|Outcome|"CPAP Mask First Night | FRESCA Mask Second Night"|"One night using CPAP nasal mask and then second night using FRESCA nasal mask~CPAP Nasal Mask: CPAP nasal pillow and nasal mask"
36813|NCT02387476|O1|Outcome|"FRESCA Mask First Night | CPAP Second Night"|"First night using FRESCA nasal mask and second night using CPAP~FRESCA Nasal Mask: FRESCA nasal mask"
36814|NCT02387476|O2|Outcome|"CPAP Mask First Night | FRESCA Mask Second Night"|"One night using CPAP nasal mask and then second night using FRESCA nasal mask~CPAP Nasal Mask: CPAP nasal pillow and nasal mask"
36816|NCT02387476|O2|Outcome|CPAP Mask First Night|"One night using CPAP nasal mask and then second night using FRESCA nasal mask~CPAP Nasal Mask: CPAP nasal pillow and nasal mask"
36817|NCT02387476|O1|Outcome|FRESCA Mask First Night|"First night using FRESCA nasal mask and second night using CPAP~FRESCA Nasal Mask: FRESCA nasal mask"
36818|NCT02387476|O2|Outcome|CPAP Mask First Night|"One night using CPAP nasal mask and then second night using FRESCA nasal mask~CPAP Nasal Mask: CPAP nasal pillow and nasal mask"
36819|NCT02387476|O1|Outcome|FRESCA Mask First Night|"First night using FRESCA nasal mask and second night using CPAP~FRESCA Nasal Mask: FRESCA nasal mask"
36820|NCT02387476|O2|Outcome|CPAP Mask First Night|"One night using CPAP nasal mask and then second night using FRESCA nasal mask~CPAP Nasal Mask: CPAP nasal pillow and nasal mask"
36821|NCT02387476|O1|Outcome|FRESCA Mask First Night|"First night using FRESCA nasal mask and second night using CPAP~FRESCA Nasal Mask: FRESCA nasal mask"
36822|NCT02387476|E2|Reported Event|CPAP Mask|Each patient used both devices, the analysis of the Adverse Events is recorded for both technology. This arm is associated with the CPAP Mask.
36823|NCT02387476|E1|Reported Event|FRESCA Mask|Each patient used both devices, the analysis of the Adverse Events is recorded for both technology. This arm is associated with the FRESCA Mask.
36824|NCT02387268|B1|Baseline|CleanC|"Standard colonoscopy procedure using the CleanC system~CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure"
36825|NCT02387268|P1|Participant Flow|CleanC|"Standard colonoscopy procedure using the CleanC system~CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure"
36826|NCT02387268|O1|Outcome|CleanC|"Standard colonoscopy procedure using the CleanC system~CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure"
36827|NCT02387268|O1|Outcome|CleanC|"Standard colonoscopy procedure using the CleanC system~CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure"
36828|NCT02387268|E1|Reported Event|CleanC|"Standard colonoscopy procedure using the CleanC system~CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure"
36829|NCT02384538|B3|Baseline|Total|Total of all reporting groups
36830|NCT02384538|B2|Baseline|ABT-981|ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
36831|NCT02384538|B1|Baseline|Placebo|Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
36832|NCT02384538|P2|Participant Flow|ABT-981|ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
36833|NCT02384538|P1|Participant Flow|Placebo|Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
36834|NCT02384538|O2|Outcome|ABT-981|ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
36835|NCT02384538|O1|Outcome|Placebo|Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
36836|NCT02384538|O2|Outcome|ABT-981|ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
36837|NCT02384538|O1|Outcome|Placebo|Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
36838|NCT02384538|O2|Outcome|ABT-981|ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
36839|NCT02384538|O1|Outcome|Placebo|Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
36840|NCT02384538|O2|Outcome|ABT-981|ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
36841|NCT02384538|O1|Outcome|Placebo|Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
36842|NCT02384538|O2|Outcome|ABT-981|ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
36843|NCT02384538|O1|Outcome|Placebo|Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
36844|NCT02384538|O2|Outcome|ABT-981|ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
36845|NCT02384538|O1|Outcome|Placebo|Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
36846|NCT02384538|O2|Outcome|ABT-981|ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
36847|NCT02384538|O1|Outcome|Placebo|Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
36848|NCT02384538|E2|Reported Event|ABT-981|ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
36849|NCT02384538|E1|Reported Event|Placebo|Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
36850|NCT02384070|B4|Baseline|Total|Total of all reporting groups
36851|NCT02384070|B3|Baseline|Group 3: Upstream Aspirin Plus Bivalirudin|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
36852|NCT02384070|B2|Baseline|Group 2: Upstream Aspirin and Clopidrogel Plus Bivalirudin|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
36853|NCT02384070|B1|Baseline|Group 1: Upstream Aspirin + Clopidrogel|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure"
36854|NCT02384070|P3|Participant Flow|Group 3: Upstream Aspirin Plus Bivalirudin|Received only upstream single anti-platelet therapy with aspirin plus intra-procedural anticoagulation for the FFR calculation with bivalirudin
36855|NCT02384070|P2|Participant Flow|Group 2: Upstream Aspirin and Clopidrogel Plus Bivalirudin|Received upstream aspirin and clopidogrel plus intra-procedural anticoagulation with bivalirudin for FFR calculation
36856|NCT02384070|P1|Participant Flow|Group 1: Upstream Aspirin + Clopidrogel|Received upstream aspirin plus clopidogrel with no intra-procedural anticoagulation for the FFR calculation with a saline bolus and drip used for placebo anticoagulation during the procedure to blind the operator
36857|NCT02384070|O3|Outcome|Group 3|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
36858|NCT02384070|O2|Outcome|Group 2|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
40002|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
36859|NCT02384070|O1|Outcome|Group 1|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure"
36860|NCT02384070|O3|Outcome|Group 3|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
36861|NCT02384070|O2|Outcome|Group 2|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
36862|NCT02384070|O1|Outcome|Group 1|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure"
36863|NCT02384070|O3|Outcome|Group 3|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
36864|NCT02384070|O2|Outcome|Group 2|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
36865|NCT02384070|O1|Outcome|Group 1|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure"
36866|NCT02384070|E3|Reported Event|Group 3|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
36867|NCT02384070|E2|Reported Event|Group 2|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
36868|NCT02384070|E1|Reported Event|Group 1|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure"
36869|NCT02383862|B3|Baseline|Total|Total of all reporting groups
36870|NCT02383862|B2|Baseline|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
36871|NCT02383862|B1|Baseline|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit~Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
36872|NCT02383862|P2|Participant Flow|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
36873|NCT02383862|P1|Participant Flow|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit~Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
36874|NCT02383862|O2|Outcome|Control Group (EMR)|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit, and whose electronic medical record of the baseline clinic visit was available for review
36875|NCT02383862|O1|Outcome|Feedback Group (EMR)|Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit, and whose electronic medical record of the baseline clinic visit was available for review
36876|NCT02383862|O2|Outcome|Control Group (EMR)|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit, and whose electronic medical record of the baseline clinic visit was available for review
36877|NCT02383862|O1|Outcome|Feedback Group (EMR)|Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit, and whose electronic medical record of the baseline clinic visit was available for review
36878|NCT02383862|O2|Outcome|Control Group (EMR)|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit, and whose electronic medical record of the baseline clinic visit was available for review
36879|NCT02383862|O1|Outcome|Feedback Group (EMR)|Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit, and whose electronic medical record of the baseline clinic visit was available for review
36880|NCT02383862|O2|Outcome|Control Group (EMR)|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit, and whose electronic medical record of the baseline clinic visit was available for review
36881|NCT02383862|O1|Outcome|Feedback Group (EMR)|Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit, and whose electronic medical record of the baseline clinic visit was available for review
36882|NCT02383862|O1|Outcome|Follow up Sample Responding to SF-36 Vitality Scale (n=256)|Of the 300 participants invited to complete the 3-month follow up assessment, 256 participants responded to items on the SF-36 vitality scale. No group comparisons were made.
36883|NCT02383862|O1|Outcome|Follow up Sample Responding to PHQ-2 (n=255)|Of the 300 participants invited to complete the 3-month follow up assessment, 255 participants responded to items on the PHQ-2. No group comparisons were made.
36884|NCT02383862|O1|Outcome|Follow up Sample Responding to GAD-2 (n=256)|Of the 300 participants invited to complete the 3-month follow up assessment, 256 participants responded to items on the GAD-2. No group comparisons were made.
36885|NCT02383862|O1|Outcome|Follow up Sample Responding to PEG (n=255)|Of the 300 participants invited to complete the 3-month follow up assessment, 255 participants responded to items on PEG. No group comparisons were made.
36886|NCT02383862|O1|Outcome|Follow up Sample Responding to PIRS-2 (N=255)|Of the 300 participants invited to complete the 3-month follow up assessment, 255 participants responded to items on the PIRS-2. No group comparisons were made.
37145|NCT02381288|O3|Outcome|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
36887|NCT02383862|O2|Outcome|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
36888|NCT02383862|O1|Outcome|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit~Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
36889|NCT02383862|O2|Outcome|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
36890|NCT02383862|O1|Outcome|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit~Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
36891|NCT02383862|O2|Outcome|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
36892|NCT02383862|O1|Outcome|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit~Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
36893|NCT02383862|O2|Outcome|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
36894|NCT02383862|O1|Outcome|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit~Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
36895|NCT02383862|O2|Outcome|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
36896|NCT02383862|O1|Outcome|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit~Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
36897|NCT02383862|O2|Outcome|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
36898|NCT02383862|O1|Outcome|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit~Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
36899|NCT02383862|O2|Outcome|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
36900|NCT02383862|O1|Outcome|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit~Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
36901|NCT02383862|E2|Reported Event|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
36902|NCT02383862|E1|Reported Event|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit~Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
36903|NCT02383758|B3|Baseline|Total|Total of all reporting groups
36904|NCT02383758|B2|Baseline|Waitlist Control|"Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program 8 weeks after providing consent.~Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.~Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.~Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began."
36905|NCT02383758|B1|Baseline|Treatment Program|"Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program immediately.~Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.~Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.~Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began."
36906|NCT02383758|P2|Participant Flow|Waitlist Control|"Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program 8 weeks after providing consent.~Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.~Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.~Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began."
36907|NCT02383758|P1|Participant Flow|Treatment Program|"Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program immediately.~Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.~Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.~Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began."
36908|NCT02383758|O2|Outcome|Waitlist Control|"Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program 8 weeks after providing consent.~Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.~Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.~Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began."
37146|NCT02381288|O2|Outcome|TAK-448 0.1 µg|TAK-448 0.1 mcg, injection, subcutaneously, once daily on Days 1 through 42.
36909|NCT02383758|O1|Outcome|Treatment Program|"Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program immediately.~Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.~Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.~Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began."
36910|NCT02383758|O2|Outcome|Waitlist Control|"Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program 8 weeks after providing consent.~Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.~Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.~Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began."
36911|NCT02383758|O1|Outcome|Treatment Program|"Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program immediately.~Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.~Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.~Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began."
36912|NCT02383758|O2|Outcome|Waitlist Control|"Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program 8 weeks after providing consent.~Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.~Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.~Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began."
36913|NCT02383758|O1|Outcome|Treatment Program|"Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program immediately.~Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.~Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.~Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began."
36914|NCT02383758|O2|Outcome|Waitlist Control|"Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program 8 weeks after providing consent.~Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.~Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.~Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began."
36915|NCT02383758|O1|Outcome|Treatment Program|"Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program immediately.~Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.~Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.~Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began."
36916|NCT02383758|E2|Reported Event|Waitlist Control|"Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program 8 weeks after providing consent.~Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.~Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.~Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began."
36917|NCT02383758|E1|Reported Event|Treatment Program|"Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program immediately.~Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.~Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.~Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began."
36918|NCT02383719|B1|Baseline|Oro-nasal Mask|Oro-nasal Mask
36919|NCT02383719|P1|Participant Flow|Oro-nasal Mask|Oro-nasal Mask
36920|NCT02383719|O1|Outcome|Oro-nasal Mask|All patients in this group received the experimental oro-nasal mask for evaluation of use. Patient's received non-invasive ventilation were switched to this mask upone study initiation.
36921|NCT02383719|E1|Reported Event|Oro-nasal Mask|Oro-nasal Mask
36922|NCT02383576|B3|Baseline|Total|Total of all reporting groups
36923|NCT02383576|B2|Baseline|Bevacizumab and Capecitabine|Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
36924|NCT02383576|B1|Baseline|Bevacizumab|Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
36925|NCT02383576|P2|Participant Flow|Bevacizumab and Capecitabine|Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
36926|NCT02383576|P1|Participant Flow|Bevacizumab|Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
36927|NCT02383576|O2|Outcome|Bevacizumab and Capecitabine|Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
36928|NCT02383576|O1|Outcome|Bevacizumab|Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
36929|NCT02383576|O2|Outcome|Bevacizumab and Capecitabine|Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
36930|NCT02383576|O1|Outcome|Bevacizumab|Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
36931|NCT02383576|O2|Outcome|Bevacizumab and Capecitabine|Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
36932|NCT02383576|O1|Outcome|Bevacizumab|Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
36933|NCT02383576|O2|Outcome|Bevacizumab and Capecitabine|Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
36934|NCT02383576|O1|Outcome|Bevacizumab|Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
36935|NCT02383576|O2|Outcome|Bevacizumab and Capecitabine|Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
36936|NCT02383576|O1|Outcome|Bevacizumab|Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
36937|NCT02383576|E2|Reported Event|Bevacizumab and Capecitabine|Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
36938|NCT02383576|E1|Reported Event|Bevacizumab|Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
36939|NCT02383420|B4|Baseline|Total|Total of all reporting groups
36940|NCT02383420|B3|Baseline|Predicate & Invest.-Cadavers GOS & CsI|Radiation - Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector.
36941|NCT02383420|B2|Baseline|Predicate & Invest.-CsI|Radiation - Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
36942|NCT02383420|B1|Baseline|Predicate & Invest.-GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
36943|NCT02383420|P3|Participant Flow|Predicate & Investigational-Cadavers|Radiation - Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector.
36944|NCT02383420|P2|Participant Flow|Predicate & Invest.-CsI|Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
36945|NCT02383420|P1|Participant Flow|Predicate & Invest.-GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
36946|NCT02383420|O1|Outcome|Image Pair Preference|Preference for predicate detector DRX-1 image versus preference for investigational DRX-PRO 3543/C (GOS & CsI) and vice versa.
36947|NCT02383420|O2|Outcome|Investigational|DRX PRO 3543/C (GOS & CsI) Detectors, Live Subjects & Cadavers
36948|NCT02383420|O1|Outcome|Predicate|DRX-1 Detector, Live Subjects and Cadavers
36949|NCT02383420|E3|Reported Event|Predicate & Invest.-Cadavers GOS & CsI|Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detectors.
36950|NCT02383420|E2|Reported Event|Predicate & Invest.-CsI|Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
36951|NCT02383420|E1|Reported Event|Predicate & Invest.-GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
36952|NCT02382913|B11|Baseline|Total|Total of all reporting groups
36953|NCT02382913|B10|Baseline|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36954|NCT02382913|B9|Baseline|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36955|NCT02382913|B8|Baseline|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36956|NCT02382913|B7|Baseline|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36957|NCT02382913|B6|Baseline|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36958|NCT02382913|B5|Baseline|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
37105|NCT02381418|O1|Outcome|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
36959|NCT02382913|B4|Baseline|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36960|NCT02382913|B3|Baseline|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36961|NCT02382913|B2|Baseline|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36962|NCT02382913|B1|Baseline|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36963|NCT02382913|P10|Participant Flow|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36964|NCT02382913|P9|Participant Flow|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36965|NCT02382913|P8|Participant Flow|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36966|NCT02382913|P7|Participant Flow|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36967|NCT02382913|P6|Participant Flow|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36968|NCT02382913|P5|Participant Flow|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36969|NCT02382913|P4|Participant Flow|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36970|NCT02382913|P3|Participant Flow|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36971|NCT02382913|P2|Participant Flow|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36972|NCT02382913|P1|Participant Flow|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36973|NCT02382913|O4|Outcome|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36974|NCT02382913|O3|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36975|NCT02382913|O2|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36976|NCT02382913|O1|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36977|NCT02382913|O4|Outcome|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36978|NCT02382913|O3|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36979|NCT02382913|O2|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36980|NCT02382913|O1|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36981|NCT02382913|O4|Outcome|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
40003|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
36982|NCT02382913|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36983|NCT02382913|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36984|NCT02382913|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36985|NCT02382913|O4|Outcome|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36986|NCT02382913|O3|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36987|NCT02382913|O2|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36988|NCT02382913|O1|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36989|NCT02382913|O4|Outcome|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36990|NCT02382913|O3|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36991|NCT02382913|O2|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36992|NCT02382913|O1|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36993|NCT02382913|O4|Outcome|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36994|NCT02382913|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36995|NCT02382913|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36996|NCT02382913|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36997|NCT02382913|E10|Reported Event|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36998|NCT02382913|E9|Reported Event|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
36999|NCT02382913|E8|Reported Event|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
37000|NCT02382913|E7|Reported Event|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
37001|NCT02382913|E6|Reported Event|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
37002|NCT02382913|E5|Reported Event|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
37003|NCT02382913|E4|Reported Event|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
37004|NCT02382913|E3|Reported Event|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
37141|NCT02381288|O3|Outcome|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
37005|NCT02382913|E2|Reported Event|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
37006|NCT02382913|E1|Reported Event|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
37007|NCT02382744|B3|Baseline|Total|Total of all reporting groups
37008|NCT02382744|B2|Baseline|Ultrasound Guidance and Nerve Stimulation|"Saphenous nerve block placed using ultrasound guidance and nerve stimulation~Ultrasound guidance and nerve stimulation: Ultrasound guidance and nerve stimulation will be used to place a saphenous nerve block"
37009|NCT02382744|B1|Baseline|Ultrasound Guidance|"Saphenous nerve block placed using ultrasound guidance alone~Ultrasound Guidance: Ultrasound guidance will be used to place a saphenous nerve block"
37010|NCT02382744|P2|Participant Flow|Ultrasound Guidance and Nerve Stimulation|"Saphenous nerve block placed using ultrasound guidance and nerve stimulation~Ultrasound guidance and nerve stimulation: Ultrasound guidance and nerve stimulation will be used to place a saphenous nerve block"
37011|NCT02382744|P1|Participant Flow|Ultrasound Guidance|"Saphenous nerve block placed using ultrasound guidance alone~Ultrasound Guidance: Ultrasound guidance will be used to place a saphenous nerve block"
37012|NCT02382744|O2|Outcome|Non-responders to Nerve Stimulation|participants in the Ultrasound Guidance and Nerve Stimulation group with no response to nerve stimulation
37013|NCT02382744|O1|Outcome|Responders to Nerve Stimulation|Participants in the Ultrasound Guidance and Nerve Stimulation group with response to nerve stimulation
37014|NCT02382744|O2|Outcome|Ultrasound Guidance + Nerve Stimulation|"Saphenous nerve block placed using ultrasound guidance and nerve stimulation~Ultrasound guidance and nerve stimulation: Ultrasound guidance and nerve stimulation will be used to place a saphenous nerve block"
37015|NCT02382744|O1|Outcome|Ultrasound Guidance|"Saphenous nerve block placed using ultrasound guidance alone~Ultrasound Guidance: Ultrasound guidance will be used to place a saphenous nerve block"
37016|NCT02382744|O2|Outcome|Ultrasound Guidance + Nerve Stimulation|"Saphenous nerve block placed using ultrasound guidance and nerve stimulation~Ultrasound guidance and nerve stimulation: Ultrasound guidance and nerve stimulation will be used to place a saphenous nerve block"
37017|NCT02382744|O1|Outcome|Ultrasound Guidance|"Saphenous nerve block placed using ultrasound guidance alone~Ultrasound Guidance: Ultrasound guidance will be used to place a saphenous nerve block"
37018|NCT02382744|O2|Outcome|Ultrasound Guidance + Nerve Stimulation|"Saphenous nerve block placed using ultrasound guidance and nerve stimulation~Ultrasound guidance and nerve stimulation: Ultrasound guidance and nerve stimulation will be used to place a saphenous nerve block"
37019|NCT02382744|O1|Outcome|Ultrasound Guidance|"Saphenous nerve block placed using ultrasound guidance alone~Ultrasound Guidance: Ultrasound guidance will be used to place a saphenous nerve block"
37020|NCT02382744|O2|Outcome|Ultrasound Guidance + Nerve Stimulation|"Saphenous nerve block placed using ultrasound guidance and nerve stimulation~Ultrasound guidance and nerve stimulation: Ultrasound guidance and nerve stimulation will be used to place a saphenous nerve block"
37021|NCT02382744|O1|Outcome|Ultrasound Guidance|"Saphenous nerve block placed using ultrasound guidance alone~Ultrasound Guidance: Ultrasound guidance will be used to place a saphenous nerve block"
37022|NCT02382744|O2|Outcome|Ultrasound Guidance + Nerve Stimulation|"Saphenous nerve block placed using ultrasound guidance and nerve stimulation~Ultrasound guidance and nerve stimulation: Ultrasound guidance and nerve stimulation will be used to place a saphenous nerve block"
37023|NCT02382744|O1|Outcome|Ultrasound Guidance|"Saphenous nerve block placed using ultrasound guidance alone~Ultrasound Guidance: Ultrasound guidance will be used to place a saphenous nerve block"
37024|NCT02382744|O2|Outcome|Ultrasound Guidance + Nerve Stimulation|"Saphenous nerve block placed using ultrasound guidance and nerve stimulation~Ultrasound guidance and nerve stimulation: Ultrasound guidance and nerve stimulation will be used to place a saphenous nerve block"
37025|NCT02382744|O1|Outcome|Ultrasound Guidance|"Saphenous nerve block placed using ultrasound guidance alone~Ultrasound Guidance: Ultrasound guidance will be used to place a saphenous nerve block"
37026|NCT02382744|O1|Outcome|Ultrasound Guidance and Nerve Stimulation|"Saphenous nerve block placed using ultrasound guidance and nerve stimulation~Ultrasound guidance and nerve stimulation: Ultrasound guidance and nerve stimulation will be used to place a saphenous nerve block"
37027|NCT02382744|O1|Outcome|Ultrasound Guidance + Nerve Stimulation|"Saphenous nerve block placed using ultrasound guidance and nerve stimulation~Ultrasound guidance and nerve stimulation: Ultrasound guidance and nerve stimulation will be used to place a saphenous nerve block"
37028|NCT02382744|O1|Outcome|Ultrasound Guidance + Nerve Stimulation|"Saphenous nerve block placed using ultrasound guidance and nerve stimulation~Ultrasound guidance and nerve stimulation: Ultrasound guidance and nerve stimulation will be used to place a saphenous nerve block"
37029|NCT02382744|O2|Outcome|Ultrasound Guidance + Nerve Stimulation|"Saphenous nerve block placed using ultrasound guidance and nerve stimulation~Ultrasound guidance and nerve stimulation: Ultrasound guidance and nerve stimulation will be used to place a saphenous nerve block"
37030|NCT02382744|O1|Outcome|Ultrasound Guidance|"Saphenous nerve block placed using ultrasound guidance alone~Ultrasound Guidance: Ultrasound guidance will be used to place a saphenous nerve block"
37031|NCT02382744|O2|Outcome|Ultrasound Guidance + Nerve Stimulation|"Saphenous nerve block placed using ultrasound guidance and nerve stimulation~Ultrasound guidance and nerve stimulation: Ultrasound guidance and nerve stimulation will be used to place a saphenous nerve block"
37032|NCT02382744|O1|Outcome|Ultrasound Guidance|"Saphenous nerve block placed using ultrasound guidance alone~Ultrasound Guidance: Ultrasound guidance will be used to place a saphenous nerve block"
37033|NCT02382744|O2|Outcome|Ultrasound Guidance + Nerve Stimulation|"Saphenous nerve block placed using ultrasound guidance and nerve stimulation~Ultrasound guidance and nerve stimulation: Ultrasound guidance and nerve stimulation will be used to place a saphenous nerve block"
37034|NCT02382744|O1|Outcome|Ultrasound Guidance|"Saphenous nerve block placed using ultrasound guidance alone~Ultrasound Guidance: Ultrasound guidance will be used to place a saphenous nerve block"
37142|NCT02381288|O2|Outcome|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
37035|NCT02382744|O2|Outcome|Ultrasound Guidance + Nerve Stimulation|"Saphenous nerve block placed using ultrasound guidance and nerve stimulation~Ultrasound guidance and nerve stimulation: Ultrasound guidance and nerve stimulation will be used to place a saphenous nerve block"
37036|NCT02382744|O1|Outcome|Ultrasound Guidance|"Saphenous nerve block placed using ultrasound guidance alone~Ultrasound Guidance: Ultrasound guidance will be used to place a saphenous nerve block"
37037|NCT02382744|O2|Outcome|Ultrasound Guidance + Nerve Stimulation|"Saphenous nerve block placed using ultrasound guidance and nerve stimulation~Ultrasound guidance and nerve stimulation: Ultrasound guidance and nerve stimulation will be used to place a saphenous nerve block"
37038|NCT02382744|O1|Outcome|Ultrasound Guidance|"Saphenous nerve block placed using ultrasound guidance alone~Ultrasound Guidance: Ultrasound guidance will be used to place a saphenous nerve block"
37039|NCT02382744|E2|Reported Event|Ultrasound Guidance and Nerve Stimulation|"Saphenous nerve block placed using ultrasound guidance and nerve stimulation~Ultrasound guidance and nerve stimulation: Ultrasound guidance and nerve stimulation will be used to place a saphenous nerve block"
37040|NCT02382744|E1|Reported Event|Ultrasound Guidance|"Saphenous nerve block placed using ultrasound guidance alone~Ultrasound Guidance: Ultrasound guidance will be used to place a saphenous nerve block"
37041|NCT02382640|B5|Baseline|Total|Total of all reporting groups
37042|NCT02382640|B4|Baseline|Regimen B, Then C, Then A, Then D|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of second intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of third intervention period (3 Days), Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of fourth intervention period (3 Days).
37043|NCT02382640|B3|Baseline|Regimen C, Then D, Then B, Then A|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of third intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of fourth intervention period (3 Days).
37044|NCT02382640|B2|Baseline|Regimen D, Then A, Then C, Then B|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of first intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of third intervention period (3 Days), followed by 1 week washout period, followed by Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]).
37045|NCT02382640|B1|Baseline|Regimen A, Then B, Then D, Then C|Regimen(Reg)A(Febuxostat XR 80mg,capsule, orally, single dose after a 10hour(hr) fast and concurrently with Maalox 20mL(200mg magnesium hydroxide, 200mg aluminum hydroxide, and 20mg simethicone/5mL)or equivalent brand antacid, suspension, orally, single dose) on Day1 of first intervention period(3 Days),followed by 1week washout period, followed by RegB(Maalox 20mL,suspension,orally, single dose after a 9hr fast,followed by Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast[or 1hr after antacid dose]) on Day1 of second intervention period(3Days),followed by 1 week washout period, followed by RegD(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast) on Day 1 of third intervention period(3Days),followed by 1week washout period, followed by RegC(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast followed by Maalox 20mL, suspension, orally, single dose after 11hr fast[or 1hr after Febuxostat dose]) on Day1 of fourth intervention period(3 Days).
37046|NCT02382640|P4|Participant Flow|Regimen B, Then C, Then A, Then D|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of second intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of third intervention period (3 Days), Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of fourth intervention period (3 Days).
37047|NCT02382640|P3|Participant Flow|Regimen C, Then D, Then B, Then A|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of third intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of fourth intervention period (3 Days).
37072|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
40004|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
37048|NCT02382640|P2|Participant Flow|Regimen D, Then A, Then C, Then B|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of first intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of third intervention period (3 Days), followed by 1 week washout period, followed by Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]).
37049|NCT02382640|P1|Participant Flow|Regimen A, Then B, Then D, Then C|Regimen(Reg)A(Febuxostat XR 80mg,capsule, orally, single dose after a 10hour(hr) fast and concurrently with Maalox 20mL(200mg magnesium hydroxide, 200mg aluminum hydroxide, and 20mg simethicone/5mL)or equivalent brand antacid, suspension, orally, single dose) on Day1 of first intervention period(3 Days),followed by 1week washout period, followed by RegB(Maalox 20mL,suspension,orally, single dose after a 9hr fast,followed by Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast[or 1hr after antacid dose]) on Day1 of second intervention period(3Days),followed by 1 week washout period, followed by RegD(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast) on Day 1 of third intervention period(3Days),followed by 1week washout period, followed by RegC(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast followed by Maalox 20mL, suspension, orally, single dose after 11hr fast[or 1hr after Febuxostat dose]) on Day1 of fourth intervention period(3 Days).
37050|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
37051|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
37052|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
37053|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
37054|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
37055|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
37056|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
37057|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
37058|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
37059|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
37060|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
37061|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
37062|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
37063|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
37064|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
37065|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
37066|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
37067|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
37068|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
37069|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
37070|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
37071|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
37073|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
37074|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
37075|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
37076|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
37077|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
37078|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
37079|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
37080|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
37081|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
37082|NCT02382640|E4|Reported Event|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
37083|NCT02382640|E3|Reported Event|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
37084|NCT02382640|E2|Reported Event|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
37085|NCT02382640|E1|Reported Event|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
37086|NCT02382133|B1|Baseline|Nasal Alar Oxygen Sensor|"Application of a nasal alar oxygen sensor~Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor"
37087|NCT02382133|P1|Participant Flow|Nasal Alar Oxygen Sensor|"Application of a nasal alar oxygen sensor~Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor"
37088|NCT02382133|O1|Outcome|Nasal Alar Oxygen Sensor|"Application of a nasal alar oxygen sensor~Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor"
37089|NCT02382133|O1|Outcome|Nasal Alar Oxygen Sensor|"Application of a nasal alar oxygen sensor~Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor"
37090|NCT02382133|E1|Reported Event|Nasal Alar Oxygen Sensor|"Application of a nasal alar oxygen sensor~Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor"
37091|NCT02381795|B1|Baseline|Nasal Carbon Dioxide|"0.17 liters (L) of carbon dioxide (CO2) will be delivered through two 10 second administrations in each nostril, up to 6 times, to treat one attack (total of 1.0 L CO2). Subjects may treat up to three cluster headache attacks during the treatment phase of this study (total of 3.0 L (CO2).~Nasal Carbon Dioxide"
37092|NCT02381795|P1|Participant Flow|Nasal Carbon Dioxide|"0.17 liters (L) of carbon dioxide (CO2) will be delivered through two 10 second administrations in each nostril, up to 6 times, to treat one attack (total of 1.0 L CO2). Subjects may treat up to three cluster headache attacks during the treatment phase of this study (total of 3.0 L (CO2).~Nasal Carbon Dioxide"
37093|NCT02381795|O1|Outcome|Nasal Carbon Dioxide|"0.17 liters (L) of carbon dioxide (CO2) will be delivered through two 10 second administrations in each nostril, up to 6 times, to treat one attack (total of 1.0 L CO2). Subjects may treat up to three cluster headache attacks during the treatment phase of this study (total of 3.0 L (CO2).~Nasal Carbon Dioxide"
37094|NCT02381795|E1|Reported Event|Nasal Carbon Dioxide|"0.17 liters (L) of carbon dioxide (CO2) will be delivered through two 10 second administrations in each nostril, up to 6 times, to treat one attack (total of 1.0 L CO2). Subjects may treat up to three cluster headache attacks during the treatment phase of this study (total of 3.0 L (CO2).~Nasal Carbon Dioxide"
37095|NCT02381678|B1|Baseline|All Patients Enrolled in Study|The whole group included 225 enrolled subjects. All 225 subjects included in the FAS(Full Analysis Set).
37096|NCT02381678|P3|Participant Flow|Age Group Above 70 Years Old|32 subjects implanted Perimount Heart Valve when the age was above 70
37097|NCT02381678|P2|Participant Flow|Age Group Between 60 and 70 Years Old|139 subjects implanted Perimount Heart Valve when the age was between 60 and 70 years old (>=60,<70)
37098|NCT02381678|P1|Participant Flow|Age Group Under 60 Years Old|54 subjects implanted Perimount Heart Valve when the age was under 60.
37099|NCT02381678|O1|Outcome|One-arm Group Included All Enrolled Subjects|This group included total 225 enrolled participants
37100|NCT02381678|E3|Reported Event|Age Group Above 70 Years Old|32 subjects implanted Perimount Heart Valve when the age was above 70
37101|NCT02381678|E2|Reported Event|Age Group Between 60 and 70 Years Old|139 subjects implanted Perimount Heart Valve when the age was between 60 and 70 years old (>=60,<70)
37102|NCT02381678|E1|Reported Event|Age Group Under 60 Years Old|54 subjects implanted Perimount Heart Valve when the age was under 60.
37103|NCT02381418|B1|Baseline|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
37104|NCT02381418|P1|Participant Flow|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg Hemagglutinin Antigen (HA) per 0.5 ml,trivalent one injection at Day 1 "
37214|NCT02379637|P2|Participant Flow|B Placebo|"Placebo~Placebo, matching capsules three times daily"
37106|NCT02381418|O1|Outcome|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg Hemagglutinin Antigen (HA) per 0.5 ml,trivalent one injection at Day 1 ~Trivalent influenza subunit vaccine Influvac: 3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
37107|NCT02381418|O1|Outcome|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
37108|NCT02381418|E1|Reported Event|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
37109|NCT02381392|B3|Baseline|Total|Total of all reporting groups
37110|NCT02381392|B2|Baseline|Standard|The nurse will use the standard technique for intravenous access (not using the Accuvein AV400). If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter with the help of the Accuvein AV400. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400 if they crossed over to the AV400 after two failures.
37111|NCT02381392|B1|Baseline|AV400|"The nurse will use the Accuvein AV400 to assist with intravenous access. If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter without using the device. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400.~Accuvein AV400: This device is FDA approved for assistance with intravenous access. It has been shown to cause no harm to patients. The device utilizes infrared technology to provide a visible map of the subject's blood vessels where the light is shone."
37112|NCT02381392|P2|Participant Flow|Standard|The nurse will use the standard technique for intravenous access (not using the Accuvein AV400). If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter with the help of the Accuvein AV400. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400 if they crossed over to the AV400 after two failures.
37113|NCT02381392|P1|Participant Flow|AV400|"The nurse will use the Accuvein AV400 to assist with intravenous access. If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter without using the device. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400.~Accuvein AV400: This device is FDA approved for assistance with intravenous access. It has been shown to cause no harm to patients. The device utilizes infrared technology to provide a visible map of the subject's blood vessels where the light is shone."
37114|NCT02381392|O2|Outcome|Standard|The nurse will use the standard technique for intravenous access (not using the Accuvein AV400). If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter with the help of the Accuvein AV400. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400 if they crossed over to the AV400 after two failures.
37115|NCT02381392|O1|Outcome|AV400|"The nurse will use the Accuvein AV400 to assist with intravenous access. If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter without using the device. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400.~Accuvein AV400: This device is FDA approved for assistance with intravenous access. It has been shown to cause no harm to patients. The device utilizes infrared technology to provide a visible map of the subject's blood vessels where the light is shone."
37116|NCT02381392|O2|Outcome|Standard|The nurse will use the standard technique for intravenous access (not using the Accuvein AV400). If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter with the help of the Accuvein AV400. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400 if they crossed over to the AV400 after two failures.
37117|NCT02381392|O1|Outcome|AV400|"The nurse will use the Accuvein AV400 to assist with intravenous access. If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter without using the device. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400.~Accuvein AV400: This device is FDA approved for assistance with intravenous access. It has been shown to cause no harm to patients. The device utilizes infrared technology to provide a visible map of the subject's blood vessels where the light is shone."
37118|NCT02381392|O2|Outcome|Standard|The nurse will use the standard technique for intravenous access (not using the Accuvein AV400). If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter with the help of the Accuvein AV400. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400 if they crossed over to the AV400 after two failures.
37143|NCT02381288|O1|Outcome|TAK-448 0.1 µg|TAK-448 0.1 µg, injection, subcutaneously, once daily on Days 1 through 42.
37144|NCT02381288|O4|Outcome|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
37119|NCT02381392|O1|Outcome|AV400|"The nurse will use the Accuvein AV400 to assist with intravenous access. If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter without using the device. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400.~Accuvein AV400: This device is FDA approved for assistance with intravenous access. It has been shown to cause no harm to patients. The device utilizes infrared technology to provide a visible map of the subject's blood vessels where the light is shone."
37120|NCT02381392|O2|Outcome|Standard|The nurse will use the standard technique for intravenous access (not using the Accuvein AV400). If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter with the help of the Accuvein AV400. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400 if they crossed over to the AV400 after two failures.
37121|NCT02381392|O1|Outcome|AV400|"The nurse will use the Accuvein AV400 to assist with intravenous access. If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter without using the device. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400.~Accuvein AV400: This device is FDA approved for assistance with intravenous access. It has been shown to cause no harm to patients. The device utilizes infrared technology to provide a visible map of the subject's blood vessels where the light is shone."
37122|NCT02381392|O2|Outcome|Standard|The nurse will use the standard technique for intravenous access (not using the Accuvein AV400). If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter with the help of the Accuvein AV400. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400 if they crossed over to the AV400 after two failures.
37123|NCT02381392|O1|Outcome|AV400|"The nurse will use the Accuvein AV400 to assist with intravenous access. If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter without using the device. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400.~Accuvein AV400: This device is FDA approved for assistance with intravenous access. It has been shown to cause no harm to patients. The device utilizes infrared technology to provide a visible map of the subject's blood vessels where the light is shone."
37124|NCT02381392|E2|Reported Event|Standard|The nurse will use the standard technique for intravenous access (not using the Accuvein AV400). If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter with the help of the Accuvein AV400. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400 if they crossed over to the AV400 after two failures.
37125|NCT02381392|E1|Reported Event|AV400|"The nurse will use the Accuvein AV400 to assist with intravenous access. If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter without using the device. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400.~Accuvein AV400: This device is FDA approved for assistance with intravenous access. It has been shown to cause no harm to patients. The device utilizes infrared technology to provide a visible map of the subject's blood vessels where the light is shone."
37126|NCT02381288|B5|Baseline|Total|Total of all reporting groups
37127|NCT02381288|B4|Baseline|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
37128|NCT02381288|B3|Baseline|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
37129|NCT02381288|B2|Baseline|TAK-448 0.1 µg|TAK-448 0.1 µg, injection, subcutaneously, once daily on Days 1 through 42.
37130|NCT02381288|B1|Baseline|Placebo|TAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.
37131|NCT02381288|P4|Participant Flow|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
37132|NCT02381288|P3|Participant Flow|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
37133|NCT02381288|P2|Participant Flow|TAK-448 0.1 µg|TAK-448 0.1 mcg, injection, subcutaneously, once daily on Days 1 through 42.
37134|NCT02381288|P1|Participant Flow|Placebo|TAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.
37135|NCT02381288|O3|Outcome|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
37136|NCT02381288|O2|Outcome|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
37137|NCT02381288|O1|Outcome|TAK-448 0.1 µg|TAK-448 0.1 µg, injection, subcutaneously, once daily on Days 1 through 42.
37138|NCT02381288|O3|Outcome|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
37139|NCT02381288|O2|Outcome|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
37140|NCT02381288|O1|Outcome|TAK-448 0.1 µg|TAK-448 0.1 µg, injection, subcutaneously, once daily on Days 1 through 42.
37147|NCT02381288|O1|Outcome|Placebo|TAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.
37148|NCT02381288|O4|Outcome|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
37149|NCT02381288|O3|Outcome|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
37150|NCT02381288|O2|Outcome|TAK-448 0.1 µg|TAK-448 0.1 mcg, injection, subcutaneously, once daily on Days 1 through 42.
37151|NCT02381288|O1|Outcome|Placebo|TAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.
37152|NCT02381288|O4|Outcome|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
37153|NCT02381288|O3|Outcome|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
37154|NCT02381288|O2|Outcome|TAK-448 0.1 µg|TAK-448 0.1 mcg, injection, subcutaneously, once daily on Days 1 through 42.
37155|NCT02381288|O1|Outcome|Placebo|TAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.
37156|NCT02381288|E4|Reported Event|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
37157|NCT02381288|E3|Reported Event|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
37158|NCT02381288|E2|Reported Event|TAK-448 0.1 µg|TAK-448 0.1 mcg, injection, subcutaneously, once daily on Days 1 through 42.
37159|NCT02381288|E1|Reported Event|Placebo|TAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.
37160|NCT02380742|B3|Baseline|Total|Total of all reporting groups
37161|NCT02380742|B2|Baseline|Placebo|"4 mL of placebo cream~Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
37162|NCT02380742|B1|Baseline|Lidocaine-prilocaine|"4 mL of lidocaine-prilocaine cream~lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
37163|NCT02380742|P2|Participant Flow|Placebo|"4 mL of placebo cream~Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
37164|NCT02380742|P1|Participant Flow|Lidocaine-prilocaine|"4 mL of lidocaine-prilocaine cream~lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
37165|NCT02380742|O2|Outcome|Placebo|"4 mL of placebo cream~Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
37166|NCT02380742|O1|Outcome|Lidocaine-prilocaine|"4 mL of lidocaine-prilocaine cream~lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
37167|NCT02380742|O2|Outcome|Placebo|"4 mL of placebo cream~Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
37215|NCT02379637|P1|Participant Flow|A N-acetylcysteine|"N-acetylcysteine~N-acetylcysteine, capsules, 800 mg 3 times daily"
37216|NCT02379637|O2|Outcome|B Placebo|"Placebo~Placebo"
37217|NCT02379637|O1|Outcome|A N-acetylcysteine|"N-acetylcysteine~N-acetylcysteine"
37218|NCT02379637|O2|Outcome|B Placebo|"Placebo~Placebo"
37219|NCT02379637|O1|Outcome|A N-acetylcysteine|"N-acetylcysteine~N-acetylcysteine"
37168|NCT02380742|O1|Outcome|Lidocaine-prilocaine|"4 mL of lidocaine-prilocaine cream~lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
37169|NCT02380742|O2|Outcome|Placebo|"4 mL of placebo cream~Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
37170|NCT02380742|O1|Outcome|Lidocaine-prilocaine|"4 mL of lidocaine-prilocaine cream~lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
37171|NCT02380742|O2|Outcome|Placebo|"4 mL of placebo cream~Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
37172|NCT02380742|O1|Outcome|Lidocaine-prilocaine|"4 mL of lidocaine-prilocaine cream~lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
37173|NCT02380742|E2|Reported Event|Placebo|"4 mL of placebo cream~Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
37174|NCT02380742|E1|Reported Event|Lidocaine-prilocaine|"4 mL of lidocaine-prilocaine cream~lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
37175|NCT02380287|B9|Baseline|Total|Total of all reporting groups
37176|NCT02380287|B8|Baseline|Cohort no.8|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
37177|NCT02380287|B7|Baseline|Cohort no.7|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
37178|NCT02380287|B6|Baseline|Cohort no.6|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
37179|NCT02380287|B5|Baseline|Cohort no.5|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
37180|NCT02380287|B4|Baseline|Cohort no.4|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
37181|NCT02380287|B3|Baseline|Cohort no.3|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
37182|NCT02380287|B2|Baseline|Cohort no.2|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
37183|NCT02380287|B1|Baseline|Cohort no.1|This cohort includes just one subject who received the maximum safe starting dose of BCD-085 (0.05 mg/kg) subcutaneously.
37184|NCT02380287|P8|Participant Flow|Cohort no.8|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level.~humanized monoclonal antibody against human IL-17"
37185|NCT02380287|P7|Participant Flow|Cohort no.7|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 8 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 8.~humanized monoclonal antibody against human IL-17"
37186|NCT02380287|P6|Participant Flow|Cohort no.6|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 7 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 7.~humanized monoclonal antibody against human IL-17"
37187|NCT02380287|P5|Participant Flow|Cohort no.5|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 6 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 6.~humanized monoclonal antibody against human IL-17"
37188|NCT02380287|P4|Participant Flow|Cohort no.4|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 5 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 5.~humanized monoclonal antibody against human IL-17"
37189|NCT02380287|P3|Participant Flow|Cohort no.3|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 4 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 4.~humanized monoclonal antibody against human IL-17"
37190|NCT02380287|P2|Participant Flow|Cohort no.2|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 3 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 3.~humanized monoclonal antibody against human IL-17"
37191|NCT02380287|P1|Participant Flow|Cohort no.1|"This cohort includes just one subject who will receive the maximum safe starting dose of BCD-085 (0.05 mg/kg) subcutaneously. If the dose limitating toxicity occurs within the first seven days after injection the study will be stopped. If there is no DLT within mentioned above period then Cohort no.2 is included.~humanized monoclonal antibody against human IL-17"
37192|NCT02380287|O1|Outcome|BCD-085|This cohort includes subjects who received any dose of BCD-085 subcutaneously.
37193|NCT02380287|E8|Reported Event|Cohort no.8|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
37194|NCT02380287|E7|Reported Event|Cohort no.7|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
37195|NCT02380287|E6|Reported Event|Cohort no.6|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
37196|NCT02380287|E5|Reported Event|Cohort no.5|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
37197|NCT02380287|E4|Reported Event|Cohort no.4|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
37198|NCT02380287|E3|Reported Event|Cohort no.3|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
37199|NCT02380287|E2|Reported Event|Cohort no.2|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
37200|NCT02380287|E1|Reported Event|Cohort no.1|This cohort includes just one subject who received the maximum safe starting dose of BCD-085 (0.05 mg/kg) subcutaneously.
37201|NCT02380261|B1|Baseline|Systane|Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
37202|NCT02380261|P1|Participant Flow|Systane|Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
37203|NCT02380261|O1|Outcome|Systane|Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
37204|NCT02380261|O1|Outcome|Systane|Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
37205|NCT02380261|E1|Reported Event|Systane|Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
37206|NCT02380248|B1|Baseline|Systane|Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops, 1 drop QID in each eye for 90 days
37207|NCT02380248|P1|Participant Flow|Systane|Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops, 1 drop QID (4 times/day) in each eye for 90 days
37208|NCT02380248|O1|Outcome|Systane|Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops, 1 drop QID in each eye for 90 days
37209|NCT02380248|E2|Reported Event|Systane|All subjects exposed to study treatment
37210|NCT02380248|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
37211|NCT02379637|B3|Baseline|Total|Total of all reporting groups
37212|NCT02379637|B2|Baseline|B Placebo|"Placebo~Placebo"
37213|NCT02379637|B1|Baseline|A N-acetylcysteine|"N-acetylcysteine~N-acetylcysteine"
37223|NCT02379585|B2|Baseline|Diagnosed With HER2 Positive Breast Cancer|will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year
37224|NCT02379585|B1|Baseline|Diagnosed With HER2 Negative Breast Cancer|Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel.
37225|NCT02379585|P2|Participant Flow|Diagnosed With HER2 Positive Breast Cancer|"will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year~docetaxel: For patients with HER2 positive breast cancer: docetaxel 75 mg/m2 every 3 weeks for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent 3 cycles), Pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles be"
37226|NCT02379585|P1|Participant Flow|Diagnosed With HER2 Negative Breast Cancer|"Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three-six weeks after completing the last cycle of paclitaxel.~Doxorubicin: For patients with HER2 negative breast cancer: doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel (T) 75 mg/m2 every 2 weeks for four cycles (dose-dense AC + T).20~cyclophosphamide: For patients with HER2 negative breast cancer: doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel (T) 75 mg/m2 every 2 weeks for four cycles (dose-dense AC + T).20~paclitaxel: For patients with HER2 negative breast cancer: doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel ("
37227|NCT02379585|O2|Outcome|Diagnosed With HER2 Positive Breast Cancer|Will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year
37228|NCT02379585|O1|Outcome|Diagnosed With HER2 Negative Breast Cancer|Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel.
37229|NCT02379585|O2|Outcome|Diagnosed With HER2 Positive Breast Cancer|Will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year
37230|NCT02379585|O1|Outcome|Diagnosed With HER2 Negative Breast Cancer|Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel.
37231|NCT02379585|O2|Outcome|Diagnosed With HER2 Positive Breast Cancer|Will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year
37232|NCT02379585|O1|Outcome|Diagnosed With HER2 Negative Breast Cancer|Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel.
37233|NCT02379585|O2|Outcome|Diagnosed With HER2 Positive Breast Cancer|Will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year
37252|NCT02378961|P4|Participant Flow|VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis
37234|NCT02379585|O1|Outcome|Diagnosed With HER2 Negative Breast Cancer|Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel.
37235|NCT02379585|O2|Outcome|Diagnosed With HER2 Positive Breast Cancer|Will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year
37236|NCT02379585|O1|Outcome|Diagnosed With HER2 Negative Breast Cancer|Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel.
37237|NCT02379585|O2|Outcome|Diagnosed With HER2 Positive Breast Cancer|Will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year
37238|NCT02379585|O1|Outcome|Diagnosed With HER2 Negative Breast Cancer|Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel.
37239|NCT02379585|O2|Outcome|Diagnosed With HER2 Positive Breast Cancer|Will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year
37240|NCT02379585|O1|Outcome|Diagnosed With HER2 Negative Breast Cancer|Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel.
37241|NCT02379585|O2|Outcome|Diagnosed With HER2 Positive Breast Cancer|Will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days).
37242|NCT02379585|O1|Outcome|Diagnosed With HER2 Negative Breast Cancer|Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles.
37243|NCT02379585|O2|Outcome|Diagnosed With HER2 Positive Breast Cancer|will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year
37244|NCT02379585|O1|Outcome|Diagnosed With HER2 Negative Breast Cancer|Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel.
37245|NCT02379585|E2|Reported Event|Diagnosed With HER2 Positive Breast Cancer|will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year
37246|NCT02379585|E1|Reported Event|Diagnosed With HER2 Negative Breast Cancer|"Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel.~0"
37247|NCT02378961|B5|Baseline|Total|Total of all reporting groups
37248|NCT02378961|B4|Baseline|VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis
37249|NCT02378961|B3|Baseline|VOX+SOF/VEL 12 Weeks, Treatment-Experienced, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis
37250|NCT02378961|B2|Baseline|VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
37251|NCT02378961|B1|Baseline|VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
40005|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
37253|NCT02378961|P3|Participant Flow|VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis
37254|NCT02378961|P2|Participant Flow|VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
37255|NCT02378961|P1|Participant Flow|VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic|Voxilaprevir (VOX) 100 mg tablet + sofosbuvir/veltapasvir (Epclusa® ; SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
37256|NCT02378961|O4|Outcome|VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis
37257|NCT02378961|O3|Outcome|VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis
37258|NCT02378961|O2|Outcome|VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
37259|NCT02378961|O1|Outcome|VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
37260|NCT02378961|O4|Outcome|VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis
37261|NCT02378961|O3|Outcome|VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis
37262|NCT02378961|O2|Outcome|VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
37263|NCT02378961|O1|Outcome|VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
37264|NCT02378961|O4|Outcome|VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis
37265|NCT02378961|O3|Outcome|VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis
37266|NCT02378961|O2|Outcome|VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
37267|NCT02378961|O1|Outcome|VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
37268|NCT02378961|O4|Outcome|VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis
37269|NCT02378961|O3|Outcome|VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis
37270|NCT02378961|O2|Outcome|VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
37271|NCT02378961|O1|Outcome|VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
37272|NCT02378961|O4|Outcome|VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis
37273|NCT02378961|O3|Outcome|VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis
37274|NCT02378961|O2|Outcome|VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
37275|NCT02378961|O1|Outcome|VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
37276|NCT02378961|O4|Outcome|VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis
37277|NCT02378961|O3|Outcome|VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis
37278|NCT02378961|O2|Outcome|VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
37279|NCT02378961|O1|Outcome|VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
37280|NCT02378961|E4|Reported Event|VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis
37281|NCT02378961|E3|Reported Event|VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis
37282|NCT02378961|E2|Reported Event|VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
37283|NCT02378961|E1|Reported Event|VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
37284|NCT02378935|B8|Baseline|Total|Total of all reporting groups
37285|NCT02378935|B7|Baseline|VOX+SOF/VEL 12 Weeks (GS-US-338-1121)|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
37286|NCT02378935|B6|Baseline|VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
37287|NCT02378935|B5|Baseline|VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
37288|NCT02378935|B4|Baseline|VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
37289|NCT02378935|B3|Baseline|VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
37290|NCT02378935|B2|Baseline|VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
37291|NCT02378935|B1|Baseline|VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
37292|NCT02378935|P7|Participant Flow|VOX+SOF/VEL 12 Weeks (GS-US-338-1121)|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
37293|NCT02378935|P6|Participant Flow|VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
37294|NCT02378935|P5|Participant Flow|VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in direct-acting antiviral (DAA) experienced participants without cirrhosis
37295|NCT02378935|P4|Participant Flow|VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
37296|NCT02378935|P3|Participant Flow|VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
37297|NCT02378935|P2|Participant Flow|VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants without cirrhosis
37298|NCT02378935|P1|Participant Flow|VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic|Voxilaprevir (VOX) 100 mg tablet + sofosbuvir/veltapasvir (Epclusa® ; SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
37299|NCT02378935|O7|Outcome|VOX+SOF/VEL 12 Weeks (GS-US-338-1121)|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
37300|NCT02378935|O6|Outcome|VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
37301|NCT02378935|O5|Outcome|VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
37302|NCT02378935|O4|Outcome|VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
37303|NCT02378935|O3|Outcome|VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
37304|NCT02378935|O2|Outcome|VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
37305|NCT02378935|O1|Outcome|VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
37306|NCT02378935|O7|Outcome|VOX+SOF/VEL 12 Weeks (GS-US-338-1121)|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
37307|NCT02378935|O6|Outcome|VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
37308|NCT02378935|O5|Outcome|VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
37309|NCT02378935|O4|Outcome|VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
37310|NCT02378935|O3|Outcome|VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
37311|NCT02378935|O2|Outcome|VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
37312|NCT02378935|O1|Outcome|VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
37313|NCT02378935|O7|Outcome|VOX+SOF/VEL 12 Weeks (GS-US-338-1121)|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
37314|NCT02378935|O6|Outcome|VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
40006|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
37315|NCT02378935|O5|Outcome|VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
37316|NCT02378935|O4|Outcome|VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
37317|NCT02378935|O3|Outcome|VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
37318|NCT02378935|O2|Outcome|VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
37319|NCT02378935|O1|Outcome|VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
37320|NCT02378935|O7|Outcome|VOX+SOF/VEL 12 Weeks (GS-US-338-1121)|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
37321|NCT02378935|O6|Outcome|VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
37322|NCT02378935|O5|Outcome|VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
37323|NCT02378935|O4|Outcome|VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
37324|NCT02378935|O3|Outcome|VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
37325|NCT02378935|O2|Outcome|VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
37326|NCT02378935|O1|Outcome|VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
37327|NCT02378935|O7|Outcome|VOX+SOF/VEL 12 Weeks (GS-US-338-1121)|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
37328|NCT02378935|O6|Outcome|VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
37329|NCT02378935|O5|Outcome|VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
37330|NCT02378935|O4|Outcome|VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
37331|NCT02378935|O3|Outcome|VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
37332|NCT02378935|O2|Outcome|VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
37333|NCT02378935|O1|Outcome|VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
37334|NCT02378935|O7|Outcome|VOX+SOF/VEL 12 Weeks (GS-US-338-1121)|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
37335|NCT02378935|O6|Outcome|VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
37336|NCT02378935|O5|Outcome|VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
37337|NCT02378935|O4|Outcome|VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
37338|NCT02378935|O3|Outcome|VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
37339|NCT02378935|O2|Outcome|VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
37340|NCT02378935|O1|Outcome|VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
37341|NCT02378935|E7|Reported Event|VOX+SOF/VEL 12 Weeks (GS-US-338-1121)|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
37342|NCT02378935|E6|Reported Event|VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
37343|NCT02378935|E5|Reported Event|VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
37344|NCT02378935|E4|Reported Event|VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
37345|NCT02378935|E3|Reported Event|VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
37346|NCT02378935|E2|Reported Event|VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
37347|NCT02378935|E1|Reported Event|VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic|VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
37348|NCT02378753|B3|Baseline|Total|Total of all reporting groups
37349|NCT02378753|B2|Baseline|rVSVΔG-ZEBOV (Deferred Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units) in participants randomized to receive deferred vaccination (18–24 weeks after enrollment).~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
37350|NCT02378753|B1|Baseline|rVSVΔG-ZEBOV (Immediate Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units)~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
37351|NCT02378753|P2|Participant Flow|rVSVΔG-ZEBOV (Deferred Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units) in participants randomized to receive deferred vaccination (18–24 weeks after enrollment).~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
37352|NCT02378753|P1|Participant Flow|rVSVΔG-ZEBOV (Immediate Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units)~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
37353|NCT02378753|O2|Outcome|rVSVΔG-ZEBOV (Deferred Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units) in participants randomized to receive deferred vaccination (18–24 weeks after enrollment).~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
37354|NCT02378753|O1|Outcome|rVSVΔG-ZEBOV (Immediate Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units)~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
37355|NCT02378753|O2|Outcome|rVSVΔG-ZEBOV (Deferred Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units) in participants randomized to receive deferred vaccination (18–24 weeks after enrollment).~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
37356|NCT02378753|O1|Outcome|rVSVΔG-ZEBOV (Immediate Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units)~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
37357|NCT02378753|O2|Outcome|rVSVΔG-ZEBOV (Deferred Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units) in participants randomized to receive deferred vaccination (18–24 weeks after enrollment).~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
37358|NCT02378753|O1|Outcome|rVSVΔG-ZEBOV (Immediate Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units)~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
37359|NCT02378753|O2|Outcome|rVSVΔG-ZEBOV (Deferred Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units) in participants randomized to receive deferred vaccination (18–24 weeks after enrollment).~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
37360|NCT02378753|O1|Outcome|rVSVΔG-ZEBOV (Immediate Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units)~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
37361|NCT02378753|O2|Outcome|rVSVΔG-ZEBOV (Deferred Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units) in participants randomized to receive deferred vaccination (18–24 weeks after enrollment).~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
37362|NCT02378753|O1|Outcome|rVSVΔG-ZEBOV (Immediate Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units)~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
37363|NCT02378753|O2|Outcome|rVSVΔG-ZEBOV (Deferred Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units) in participants randomized to receive deferred vaccination (18–24 weeks after enrollment).~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
37450|NCT02376166|O1|Outcome|Metformin|850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
40007|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
37364|NCT02378753|O1|Outcome|rVSVΔG-ZEBOV (Immediate Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units)~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
37365|NCT02378753|O2|Outcome|rVSVΔG-ZEBOV (Deferred Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units) in participants randomized to receive deferred vaccination (18–24 weeks after enrollment).~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
37366|NCT02378753|O1|Outcome|rVSVΔG-ZEBOV (Immediate Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units)~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
37367|NCT02378753|E2|Reported Event|rVSVΔG-ZEBOV (Deferred Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units) in participants randomized to receive deferred vaccination (18–24 weeks after enrollment).~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
37368|NCT02378753|E1|Reported Event|rVSVΔG-ZEBOV (Immediate Vaccination)|"One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units)~rVSVΔG-ZEBOV: The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain)."
37369|NCT02378506|B1|Baseline|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
37370|NCT02378506|P1|Participant Flow|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
37371|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
37372|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
37373|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
37374|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
37375|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
37376|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
37377|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
37378|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
37379|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
37380|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
37381|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
37382|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
37383|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
37384|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
37385|NCT02378506|E1|Reported Event|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
37386|NCT02377427|B3|Baseline|Total|Total of all reporting groups
37387|NCT02377427|B2|Baseline|Mepolizumab 100 mg SC|Participants with bodyweight >= 40 kg received 1.0 mL of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product. On investigator discretion, injected volume was split between two injection sites and was given as 2 injections of 0.5 mL each if required.
37388|NCT02377427|B1|Baseline|Mepolizumab 40 mg SC|Participants with bodyweight < 40 kilogram (kg) received 0.4 milliliter (mL) of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Participant's weight at Week 0 (Visit 2) was considered to select dosage in Part A. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
37451|NCT02376166|O1|Outcome|Metformin|850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
37564|NCT02373202|B2|Baseline|Sarilumab 200 mg q2w + DMARDs|Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37389|NCT02377427|P2|Participant Flow|Mepolizumab 100 mg SC|Participants with bodyweight >= 40 kg received 1.0 mL of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product. On investigator discretion, injected volume was split between two injection sites and was given as 2 injections of 0.5 mL each if required.
37390|NCT02377427|P1|Participant Flow|Mepolizumab 40 mg SC|Participants with bodyweight < 40 kilogram (kg) received 0.4 milliliter (mL) of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Participant's weight at Week 0 (Visit 2) was considered to select dosage in Part A. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
37391|NCT02377427|O2|Outcome|Mepolizumab 100 mg SC|Participants with bodyweight >= 40 kg received 1.0 mL of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product. On investigator discretion, injected volume was split between two injection sites and was given as 2 injections of 0.5 mL each if required.
37392|NCT02377427|O1|Outcome|Mepolizumab 40 mg SC|Participants with bodyweight < 40 kilogram (kg) received 0.4 milliliter (mL) of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Participant's weight at Week 0 (Visit 2) was considered to select dosage in Part A. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
37393|NCT02377427|O2|Outcome|Mepolizumab 100 mg SC|Participants with bodyweight >= 40 kg received 1.0 mL of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product. On investigator discretion, injected volume was split between two injection sites and was given as 2 injections of 0.5 mL each if required.
37394|NCT02377427|O1|Outcome|Mepolizumab 40 mg SC|Participants with bodyweight < 40 kilogram (kg) received 0.4 milliliter (mL) of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Participant's weight at Week 0 (Visit 2) was considered to select dosage in Part A. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
37395|NCT02377427|O2|Outcome|Mepolizumab 100 mg SC|Participants with bodyweight >= 40 kg received 1.0 mL of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product. On investigator discretion, injected volume was split between two injection sites and was given as 2 injections of 0.5 mL each if required.
37396|NCT02377427|O1|Outcome|Mepolizumab 40 mg SC|Participants with bodyweight < 40 kilogram (kg) received 0.4 milliliter (mL) of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Participant's weight at Week 0 (Visit 2) was considered to select dosage in Part A. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
37397|NCT02377427|O2|Outcome|Mepolizumab 100 mg SC|Participants with bodyweight >= 40 kg received 1.0 mL of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product. On investigator discretion, injected volume was split between two injection sites and was given as 2 injections of 0.5 mL each if required.
37398|NCT02377427|O1|Outcome|Mepolizumab 40 mg SC|Participants with bodyweight < 40 kilogram (kg) received 0.4 milliliter (mL) of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Participant's weight at Week 0 (Visit 2) was considered to select dosage in Part A. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
37399|NCT02377427|O2|Outcome|Mepolizumab 100 mg SC|Participants with bodyweight >= 40 kg received 1.0 mL of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product. On investigator discretion, injected volume was split between two injection sites and was given as 2 injections of 0.5 mL each if required.
37400|NCT02377427|O1|Outcome|Mepolizumab 40 mg SC|Participants with bodyweight < 40 kilogram (kg) received 0.4 milliliter (mL) of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Participant's weight at Week 0 (Visit 2) was considered to select dosage in Part A. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
37401|NCT02377427|O2|Outcome|Mepolizumab 100 mg SC|Participants with bodyweight >= 40 kg received 1.0 mL of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product. On investigator discretion, injected volume was split between two injection sites and was given as 2 injections of 0.5 mL each if required.
37402|NCT02377427|O1|Outcome|Mepolizumab 40 mg SC|Participants with bodyweight < 40 kilogram (kg) received 0.4 milliliter (mL) of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Participant's weight at Week 0 (Visit 2) was considered to select dosage in Part A. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
37452|NCT02376166|O1|Outcome|Metformin|850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
40008|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
37403|NCT02377427|O2|Outcome|Mepolizumab 100 mg SC|Participants with bodyweight >= 40 kg received 1.0 mL of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product. On investigator discretion, injected volume was split between two injection sites and was given as 2 injections of 0.5 mL each if required.
37404|NCT02377427|O1|Outcome|Mepolizumab 40 mg SC|Participants with bodyweight < 40 kilogram (kg) received 0.4 milliliter (mL) of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Participant's weight at Week 0 (Visit 2) was considered to select dosage in Part A. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
37405|NCT02377427|O2|Outcome|Mepolizumab 100 mg SC|Participants with bodyweight >= 40 kg received 1.0 mL of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product. On investigator discretion, injected volume was split between two injection sites and was given as 2 injections of 0.5 mL each if required.
37406|NCT02377427|O1|Outcome|Mepolizumab 40 mg SC|Participants with bodyweight < 40 kilogram (kg) received 0.4 milliliter (mL) of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Participant's weight at Week 0 (Visit 2) was considered to select dosage in Part A. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
37407|NCT02377427|O2|Outcome|Mepolizumab 100 mg SC|Participants with bodyweight >= 40 kg received 1.0 mL of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product. On investigator discretion, injected volume was split between two injection sites and was given as 2 injections of 0.5 mL each if required.
37408|NCT02377427|O1|Outcome|Mepolizumab 40 mg SC|Participants with bodyweight < 40 kilogram (kg) received 0.4 milliliter (mL) of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Participant's weight at Week 0 (Visit 2) was considered to select dosage in Part A. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
37409|NCT02377427|O2|Outcome|Mepolizumab 100 mg SC|Participants with bodyweight >= 40 kg received 1.0 mL of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product. On investigator discretion, injected volume was split between two injection sites and was given as 2 injections of 0.5 mL each if required.
37410|NCT02377427|O1|Outcome|Mepolizumab 40 mg SC|Participants with bodyweight < 40 kilogram (kg) received 0.4 milliliter (mL) of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Participant's weight at Week 0 (Visit 2) was considered to select dosage in Part A. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
37411|NCT02377427|O1|Outcome|Mepolizumab SC|Participants received mepolizumab 40 or 100 mg SC, depending on participant’s bodyweight (40 mg for <40 kg and 100 mg for >=40 kg). Participants received 0.4 mL of reconstituted mepolizumab subcutaneously (for 40 mg dose) or 1.0 mL of reconstituted mepolizumab subcutaneously (for 100 mg dose) every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
37412|NCT02377427|O2|Outcome|Mepolizumab 100 mg SC|Participants with bodyweight >= 40 kg received 1.0 mL of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product. On investigator discretion, injected volume was split between two injection sites and was given as 2 injections of 0.5 mL each if required.
37413|NCT02377427|O1|Outcome|Mepolizumab 40 mg SC|Participants with bodyweight < 40 kilogram (kg) received 0.4 milliliter (mL) of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Participant's weight at Week 0 (Visit 2) was considered to select dosage in Part A. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
37414|NCT02377427|O1|Outcome|Mepolizumab SC|Participants received mepolizumab 40 or 100 mg SC, depending on participant’s bodyweight (40 mg for <40 kg and 100 mg for >=40 kg). Participants received 0.4 mL of reconstituted mepolizumab subcutaneously (for 40 mg dose) or 1.0 mL of reconstituted mepolizumab subcutaneously (for 100 mg dose) every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
37415|NCT02377427|O1|Outcome|Mepolizumab SC|Participants received mepolizumab 40 or 100 mg SC, depending on participant’s bodyweight (40 mg for <40 kg and 100 mg for >=40 kg). Participants received 0.4 mL of reconstituted mepolizumab subcutaneously (for 40 mg dose) or 1.0 mL of reconstituted mepolizumab subcutaneously (for 100 mg dose) every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
37416|NCT02377427|O1|Outcome|Mepolizumab SC|Participants received mepolizumab 40 or 100 mg SC, depending on participant’s bodyweight (40 mg for <40 kg and 100 mg for >=40 kg). Participants received 0.4 mL of reconstituted mepolizumab subcutaneously (for 40 mg dose) or 1.0 mL of reconstituted mepolizumab subcutaneously (for 100 mg dose) every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
37561|NCT02373202|B5|Baseline|Total|Total of all reporting groups
37417|NCT02377427|O1|Outcome|Mepolizumab SC|Participants received mepolizumab 40 or 100 mg SC, depending on participant’s bodyweight (40 mg for <40 kg and 100 mg for >=40 kg). Participants received 0.4 mL of reconstituted mepolizumab subcutaneously (for 40 mg dose) or 1.0 mL of reconstituted mepolizumab subcutaneously (for 100 mg dose) every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
37418|NCT02377427|E2|Reported Event|Mepolizumab 100 mg SC|Participants with bodyweight >= 40 kg received 1.0 mL of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product. On investigator discretion, injected volume was split between two injection sites and was given as 2 injections of 0.5 mL each if required.
37419|NCT02377427|E1|Reported Event|Mepolizumab 40 mg SC|Participants with bodyweight < 40 kilogram (kg) received 0.4 milliliter (mL) of reconstituted mepolizumab subcutaneously every four weeks, in upper arm or thigh directly from the investigator or designee, under medical supervision. Participant's weight at Week 0 (Visit 2) was considered to select dosage in Part A. Prior to administration, each vial of mepolizumab were reconstituted and swirled gently to enable complete dissolution of the product.
37420|NCT02376998|B1|Baseline|Patients With Acute Transection of Thoracic Aorta|Patients with a diagnosis of acute transection of thoracic aorta.
37421|NCT02376998|P1|Participant Flow|Patients With Acute Transection of Thoracic Aorta|Patients with a diagnosis of acute transection of thoracic aorta.
37422|NCT02376998|O1|Outcome|Patients With Acute Transection of Thoracic Aorta|Patients with a diagnosis of acute transection of thoracic aorta. Mortality 0%
37423|NCT02376998|E1|Reported Event|Valiant™ Endoluminal Procedure|"Data from early and long term complications following endoluminal stent-graft placement for thoracic endovascular aortic repair (TEVAR) procedure (Valiant™ endoluminal procedure) will be collected.~Valiant™ endoluminal procedure: Thoracic endovascular aortic repair with Endoluminal stent-graft placement (Valiant™ endoluminal stent-graft systems (Medtronic Inc., Santa Rosa, CA, USA) will be performed as follows:~The diameter of the stent graft will be calculated from the largest diameter of the proximal/distal neck with an oversizing factor of 10-20%. The procedures will be done with local or general anaesthesia in case of unstable pre-operative hemodynamic conditions.~After the procedure will be completed, a digital subtraction angiography and echocardiography with color-flow mapping were performed to verify the correct positioning of the stent and to detect any primary endoleak."
37424|NCT02376530|B5|Baseline|Total|Total of all reporting groups
37425|NCT02376530|B4|Baseline|Nutrient Profiling and Price Change|Nutrient profiling system and price changes will be present during shopping session.
37426|NCT02376530|B3|Baseline|Price Change|Price changes will be present during shopping session.
37427|NCT02376530|B2|Baseline|Nutrient Profiling|Nutrient profiling system will be present during shopping session.
37428|NCT02376530|B1|Baseline|Usual Shopping|No change in condition.
37429|NCT02376530|P4|Participant Flow|Nutrient Profiling and Price Change|Nutrient profiling system and price changes will be present during shopping session.
37430|NCT02376530|P3|Participant Flow|Price Change|Price changes will be present during shopping session.
37431|NCT02376530|P2|Participant Flow|Nutrient Profiling|Nutrient profiling system will be present during shopping session.
37432|NCT02376530|P1|Participant Flow|Usual Shopping|No change in condition.
37433|NCT02376530|O4|Outcome|Nutrient Profiling and Price Change|Nutrient profiling system and price changes will be present during shopping session.
37434|NCT02376530|O3|Outcome|Price Change|Price changes will be present during shopping session.
37435|NCT02376530|O2|Outcome|Nutrient Profiling|Nutrient profiling system will be present during shopping session.
37436|NCT02376530|O1|Outcome|Usual Shopping|No change in condition.
37437|NCT02376530|E4|Reported Event|Nutrient Profiling and Price Change|Nutrient profiling system and price changes will be present during shopping session.
37438|NCT02376530|E3|Reported Event|Price Change|Price changes will be present during shopping session.
37439|NCT02376530|E2|Reported Event|Nutrient Profiling|Nutrient profiling system will be present during shopping session.
37440|NCT02376530|E1|Reported Event|Usual Shopping|No change in condition.
37441|NCT02376166|B1|Baseline|Metformin|850 mg PO once daily for 4 weeks
37442|NCT02376166|P1|Participant Flow|Metformin|"850 mg PO once daily for 4 weeks~Metformin: 850 mg PO twice daily for the remainder of the study period (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)"
37443|NCT02376166|O1|Outcome|Metformin|850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
37444|NCT02376166|O1|Outcome|Metformin|850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
37445|NCT02376166|O1|Outcome|Metformin|850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
37446|NCT02376166|O1|Outcome|Metformin|850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
37447|NCT02376166|O1|Outcome|Metformin|850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
37448|NCT02376166|O1|Outcome|Metformin|850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
37449|NCT02376166|O1|Outcome|Metformin|850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
37562|NCT02373202|B4|Baseline|Sarilumab 200 mg q2w|Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
40009|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
37453|NCT02376166|O1|Outcome|Metformin|850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
37454|NCT02376166|O1|Outcome|Metformin|850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
37455|NCT02376166|O1|Outcome|Metformin|850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
37456|NCT02376166|O1|Outcome|Metformin|850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
37457|NCT02376166|O1|Outcome|Metformin|850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
37458|NCT02376166|O1|Outcome|Metformin|850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
37459|NCT02376166|O1|Outcome|Metformin|850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
37460|NCT02376166|O1|Outcome|Metformin|850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
37461|NCT02376166|O1|Outcome|Metformin|850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
37462|NCT02376166|O1|Outcome|Metformin|850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
37463|NCT02376166|O1|Outcome|Metformin|850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
37464|NCT02376166|O1|Outcome|Metformin|850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
37465|NCT02376166|E1|Reported Event|Metformin|850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
37466|NCT02375724|B3|Baseline|Total|Total of all reporting groups
37467|NCT02375724|B2|Baseline|Placebo|Placebo BID administered by Genuair® multidose dry powder inhaler
37468|NCT02375724|B1|Baseline|Aclidinium 400 μg|Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
37469|NCT02375724|P2|Participant Flow|Placebo|Placebo BID administered by Genuair® multidose dry powder inhaler
37470|NCT02375724|P1|Participant Flow|Aclidinium 400 μg|Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
37471|NCT02375724|O2|Outcome|Placebo|Placebo BID administered by Genuair® multidose dry powder inhaler
37472|NCT02375724|O1|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
37473|NCT02375724|O2|Outcome|Placebo|Placebo BID administered by Genuair® multidose dry powder inhaler
37474|NCT02375724|O1|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
37475|NCT02375724|O2|Outcome|Placebo|Placebo BID administered by Genuair® multidose dry powder inhaler
37476|NCT02375724|O1|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
37477|NCT02375724|E2|Reported Event|Placebo|Placebo BID administered by Genuair® multidose dry powder inhaler
37478|NCT02375724|E1|Reported Event|Aclidinium 400 μg|Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
37479|NCT02375373|B1|Baseline|Obersvational Chickpea Diet|"Observed long-term to study legume intake and GI health (Observational Chickpea Diet)~Observational Chickpea Diet: Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods.~Fecal samples collected monthly."
37480|NCT02375373|P1|Participant Flow|Obersvational Chickpea Diet|"Observed long-term to study legume intake and GI health (Observational Chickpea Diet)~Observational Chickpea Diet: Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods.~Fecal samples collected monthly."
37481|NCT02375373|O1|Outcome|Obersvational Chickpea Diet|"Observed long-term to study legume intake and GI health (Observational Chickpea Diet)~Observational Chickpea Diet: Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods.~Fecal samples collected monthly."
37482|NCT02375373|E1|Reported Event|Obersvational Chickpea Diet|"Observed long-term to study legume intake and GI health (Observational Chickpea Diet)~Observational Chickpea Diet: Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods.~Fecal samples collected monthly."
37483|NCT02375347|B1|Baseline|Chickpea Enhanced Diet|"Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term)~Chickpea Enhanced Diet (Short term): Dry Roasted Chickpeas, 21.26 gram serving size bags, by mouth five times per week.~Stool Samples collected at Day 1, Day 9, and Day 14."
37484|NCT02375347|P1|Participant Flow|Chickpea Enhanced Diet|"Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term)~Chickpea Enhanced Diet (Short term): Dry Roasted Chickpeas, 21.26 gram serving size bags, by mouth five times per week.~Stool Samples collected at Day 1, Day 9, and Day 14."
37485|NCT02375347|O1|Outcome|Chickpea Enhanced Diet|"Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term)~Chickpea Enhanced Diet (Short term): Dry Roasted Chickpeas, 21.26 gram serving size bags, by mouth five times per week.~Stool Samples collected at Day 1, Day 9, and Day 14."
40010|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
37486|NCT02375347|E1|Reported Event|Chickpea Enhanced Diet|"Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term)~Chickpea Enhanced Diet (Short term): Dry Roasted Chickpeas, 21.26 gram serving size bags, by mouth five times per week.~Stool Samples collected at Day 1, Day 9, and Day 14."
37487|NCT02374593|B3|Baseline|Total|Total of all reporting groups
37488|NCT02374593|B2|Baseline|Historical Control|Patients in this arm were treated with levothyroxine empirically with an initial dose between 10-15 mcg/kg/day.
37489|NCT02374593|B1|Baseline|Targeted Dosing|Patients in this arm will receive targeted levothyroxine dosing based on thyroid anatomy on ultrasound as follows: 10 mcg/kg for normal gland, 12 mcg/kg for ectopic gland, 15 mcg/kg for athyreosis.
37490|NCT02374593|P2|Participant Flow|Historical Control|Patients in this arm were treated with levothyroxine empirically with an initial dose between 10-15 mcg/kg/day.
37491|NCT02374593|P1|Participant Flow|Targeted Dosing|Patients in this arm will receive targeted levothyroxine dosing based on thyroid anatomy on ultrasound as follows: 10 mcg/kg for normal gland, 12 mcg/kg for ectopic gland, 15 mcg/kg for athyreosis.
37492|NCT02374593|O4|Outcome|Historical Controls|see title
37493|NCT02374593|O3|Outcome|Patients With Eutopic Thyroids|patients with eutopic thyroids
37494|NCT02374593|O2|Outcome|Patients With Dysgenetic Thyroids|patients with dysgenetic thyroids
37495|NCT02374593|O1|Outcome|Patients With Athyreosis|"Patients in this arm will receive targeted levothyroxine dosing based on thyroid anatomy at 15 mcg/kg for athyreosis.~Levothyroxine: Levothyroxine dose will be adjusted at the first clinic visit based on thyroid anatomy on ultrasound.~Ultrasound"
37496|NCT02374593|O2|Outcome|Historical Control|Patients in this arm were treated with levothyroxine empirically with an initial dose between 10-15 mcg/kg/day.
37497|NCT02374593|O1|Outcome|Targeted Dosing|Patients in this arm will receive targeted levothyroxine dosing based on thyroid anatomy on ultrasound as follows: 10 mcg/kg for normal gland, 12 mcg/kg for ectopic gland, 15 mcg/kg for athyreosis.
37498|NCT02374593|E2|Reported Event|Historical Control|Patients in this arm were treated with levothyroxine empirically with an initial dose between 10-15 mcg/kg/day.
37499|NCT02374593|E1|Reported Event|Targeted Dosing|Patients in this arm will receive targeted levothyroxine dosing based on thyroid anatomy on ultrasound as follows: 10 mcg/kg for normal gland, 12 mcg/kg for ectopic gland, 15 mcg/kg for athyreosis.
37500|NCT02374398|B5|Baseline|Total|Total of all reporting groups
37501|NCT02374398|B4|Baseline|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control Group: Saline and Standard Elecdrocautery"
37502|NCT02374398|B3|Baseline|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
37503|NCT02374398|B2|Baseline|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts~Aquamantys System: see arm/group descriptions"
37504|NCT02374398|B1|Baseline|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
37505|NCT02374398|P4|Participant Flow|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control Group: Saline and Standard Elecdrocautery"
37506|NCT02374398|P3|Participant Flow|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
37507|NCT02374398|P2|Participant Flow|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts~Aquamantys System: see arm/group descriptions"
37508|NCT02374398|P1|Participant Flow|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
37509|NCT02374398|O4|Outcome|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control Group: Saline and Standard Elecdrocautery"
37510|NCT02374398|O3|Outcome|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
37511|NCT02374398|O2|Outcome|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts~Aquamantys System: see arm/group descriptions"
37563|NCT02373202|B3|Baseline|Sarilumab 150 mg q2w|Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
40011|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
37512|NCT02374398|O1|Outcome|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
37513|NCT02374398|O4|Outcome|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control: Standard Electro-cautery and Saline"
37514|NCT02374398|O3|Outcome|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
37515|NCT02374398|O2|Outcome|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts~Aquamantys System: see arm/group descriptions"
37516|NCT02374398|O1|Outcome|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
37517|NCT02374398|O4|Outcome|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control Group: Saline and Standard Elecdrocautery"
37518|NCT02374398|O3|Outcome|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
37519|NCT02374398|O2|Outcome|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts~Aquamantys System: see arm/group descriptions"
37520|NCT02374398|O1|Outcome|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
37521|NCT02374398|O4|Outcome|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control Group: Saline and Standard Elecdrocautery"
37522|NCT02374398|O3|Outcome|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
37523|NCT02374398|O2|Outcome|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts~Aquamantys System: see arm/group descriptions"
37524|NCT02374398|O1|Outcome|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
37525|NCT02374398|O4|Outcome|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control Group: Saline and Standard Elecdrocautery"
37526|NCT02374398|O3|Outcome|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
37527|NCT02374398|O2|Outcome|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts~Aquamantys System: see arm/group descriptions"
37528|NCT02374398|O1|Outcome|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
37529|NCT02374398|E4|Reported Event|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control Group: Saline and Standard Elecdrocautery"
37530|NCT02374398|E3|Reported Event|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
40012|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
37531|NCT02374398|E2|Reported Event|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts~Aquamantys System: see arm/group descriptions"
37532|NCT02374398|E1|Reported Event|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
37533|NCT02374346|B1|Baseline|Elective Surgery Patients|All adult patients admitted in our hospital for elective general, orthopaedic, gynaecologic, ear-nose-throat (ENT) and vascular procedures.
37534|NCT02374346|P1|Participant Flow|Elective Surgery Patients|A total number of 494 patients full fit the inclusion criteria and 446 completed the study (90.3 %).The 48 patients (9.7%) who did not complete the study were those operated or discharged during weekend.
37535|NCT02374346|O2|Outcome|Postoperative Headache Patients Without Headache History|Factors for developing postoperative headache in patients without previous history of headache.
37536|NCT02374346|O1|Outcome|Postoperative Headache in the Total Sample|Factors for developing postoperative headache in the total number of participants
37537|NCT02374346|O1|Outcome|Elective Surgery Patients (Total Sample)|postoperative headache in elective surgery patients
37538|NCT02374346|E1|Reported Event|Elective Surgery Patients|A total number of 494 patients full fit the inclusion criteria and 446 completed the study (90.3 %).The 48 patients (9.7%) who did not complete the study were those operated or discharged during weekend.
37539|NCT02374164|B4|Baseline|Total|Total of all reporting groups
37540|NCT02374164|B3|Baseline|Treatment Sequence CAB|Febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 1 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 2 after a high-fat meal, followed by a 7-day washout period, followed by febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 3 after a 10-hour fast.
37541|NCT02374164|B2|Baseline|Treatment Sequence BCA|Febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 1 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 2 after a 10-hour fast, followed by a 7-day washout period, followed by Febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 3 after a high-fat meal.
37542|NCT02374164|B1|Baseline|Treatment Sequence ABC|Febuxostat extended release (XR) 80 mg, capsules, orally, once on Day 1 of Period 1 after a high-fat meal, followed by a 7-day washout period, followed by febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 2 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80, capsules, orally, once on Day 1 of Period 3 after a 10-hour fast.
37543|NCT02374164|P3|Participant Flow|Treatment Sequence CAB|Febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 1 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 2 after a high-fat meal, followed by a 7-day washout period, followed by febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 3 after a 10-hour fast.
37544|NCT02374164|P2|Participant Flow|Treatment Sequence BCA|Febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 1 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 2 after a 10-hour fast, followed by a 7-day washout period, followed by Febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 3 after a high-fat meal.
37545|NCT02374164|P1|Participant Flow|Treatment Sequence ABC|Febuxostat extended release (XR) 80 mg, capsules, orally, once on Day 1 of Period 1 after a high-fat meal, followed by a 7-day washout period, followed by febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 2 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80, capsules, orally, once on Day 1 of Period 3 after a 10-hour fast.
37546|NCT02374164|O2|Outcome|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
37547|NCT02374164|O1|Outcome|B: Febuxostat XR 40 mg (Fasting)|Febuxostat XR 40 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
37548|NCT02374164|O2|Outcome|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
37549|NCT02374164|O1|Outcome|A: Febuxostat XR 80 mg (Fed)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods 30 minutes after starting to ingest a high-fat meal.
37550|NCT02374164|O2|Outcome|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
37551|NCT02374164|O1|Outcome|B: Febuxostat XR 40 mg (Fasting)|Febuxostat XR 40 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
37552|NCT02374164|O2|Outcome|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
37553|NCT02374164|O1|Outcome|A: Febuxostat XR 80 mg (Fed)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods 30 minutes after starting to ingest a high-fat meal.
37554|NCT02374164|O2|Outcome|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
37555|NCT02374164|O1|Outcome|B: Febuxostat XR 40 mg (Fasting)|Febuxostat XR 40 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
37556|NCT02374164|O2|Outcome|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
37557|NCT02374164|O1|Outcome|A: Febuxostat XR 80 mg (Fed)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods 30 minutes after starting to ingest a high-fat meal.
37558|NCT02374164|E3|Reported Event|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
37559|NCT02374164|E2|Reported Event|B: Febuxostat XR 40 mg (Fasting)|Febuxostat XR 40 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
37560|NCT02374164|E1|Reported Event|A: Febuxostat XR 80 mg (Fed)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods 30 minutes after starting to ingest a high-fat meal.
37565|NCT02373202|B1|Baseline|Sarilumab 150 mg q2w + DMARDs|Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37566|NCT02373202|P4|Participant Flow|Sarilumab 200 mg q2w|Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
37567|NCT02373202|P3|Participant Flow|Sarilumab 150 mg q2w|Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
37568|NCT02373202|P2|Participant Flow|Sarilumab 200 mg q2w + DMARDs|Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37569|NCT02373202|P1|Participant Flow|Sarilumab 150 mg q2w + DMARDs|Participants received sarilumab 150 mg, subcutaneous (SC) injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37570|NCT02373202|O4|Outcome|Sarilumab 200 mg q2w|Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
37571|NCT02373202|O3|Outcome|Sarilumab 150 mg q2w|Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
37572|NCT02373202|O2|Outcome|Sarilumab 200 mg q2w + DMARDs|Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37573|NCT02373202|O1|Outcome|Sarilumab 150 mg q2w + DMARDs|Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37574|NCT02373202|O4|Outcome|Sarilumab 200 mg q2w|Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
37575|NCT02373202|O3|Outcome|Sarilumab 150 mg q2w|Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
37576|NCT02373202|O2|Outcome|Sarilumab 200 mg q2w + DMARDs|Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37577|NCT02373202|O1|Outcome|Sarilumab 150 mg q2w + DMARDs|Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37578|NCT02373202|O4|Outcome|Sarilumab 200 mg q2w|Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
37579|NCT02373202|O3|Outcome|Sarilumab 150 mg q2w|Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
37580|NCT02373202|O2|Outcome|Sarilumab 200 mg q2w + DMARDs|Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37581|NCT02373202|O1|Outcome|Sarilumab 150 mg q2w + DMARDs|Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37582|NCT02373202|O4|Outcome|Sarilumab 200 mg q2w|Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
37583|NCT02373202|O3|Outcome|Sarilumab 150 mg q2w|Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
37584|NCT02373202|O2|Outcome|Sarilumab 200 mg q2w + DMARDs|Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37585|NCT02373202|O1|Outcome|Sarilumab 150 mg q2w + DMARDs|Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37586|NCT02373202|O4|Outcome|Sarilumab 200 mg q2w|Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
37587|NCT02373202|O3|Outcome|Sarilumab 150 mg q2w|Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
37588|NCT02373202|O2|Outcome|Sarilumab 200 mg q2w + DMARDs|Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37589|NCT02373202|O1|Outcome|Sarilumab 150 mg q2w + DMARDs|Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37590|NCT02373202|O4|Outcome|Sarilumab 200 mg q2w|Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
37591|NCT02373202|O3|Outcome|Sarilumab 150 mg q2w|Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
37592|NCT02373202|O2|Outcome|Sarilumab 200 mg q2w + DMARDs|Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37593|NCT02373202|O1|Outcome|Sarilumab 150 mg q2w + DMARDs|Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37594|NCT02373202|O4|Outcome|Sarilumab 200 mg q2w|Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
37595|NCT02373202|O3|Outcome|Sarilumab 150 mg q2w|Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
37596|NCT02373202|O2|Outcome|Sarilumab 200 mg q2w + DMARDs|Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37597|NCT02373202|O1|Outcome|Sarilumab 150 mg q2w + DMARDs|Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37598|NCT02373202|O4|Outcome|Sarilumab 200 mg q2w|Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
37599|NCT02373202|O3|Outcome|Sarilumab 150 mg q2w|Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
37600|NCT02373202|O2|Outcome|Sarilumab 200 mg q2w + DMARDs|Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37601|NCT02373202|O1|Outcome|Sarilumab 150 mg q2w + DMARDs|Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37602|NCT02373202|O4|Outcome|Sarilumab 200 mg q2w|Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
37603|NCT02373202|O3|Outcome|Sarilumab 150 mg q2w|Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
37604|NCT02373202|O2|Outcome|Sarilumab 200 mg q2w + DMARDs|Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37605|NCT02373202|O1|Outcome|Sarilumab 150 mg q2w + DMARDs|Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37606|NCT02373202|O4|Outcome|Sarilumab 200 mg q2w|Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
37607|NCT02373202|O3|Outcome|Sarilumab 150 mg q2w|Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
37608|NCT02373202|O2|Outcome|Sarilumab 200 mg q2w + DMARDs|Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37609|NCT02373202|O1|Outcome|Sarilumab 150 mg q2w + DMARDs|Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37610|NCT02373202|O4|Outcome|Sarilumab 200 mg q2w|Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
37611|NCT02373202|O3|Outcome|Sarilumab 150 mg q2w|Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
37612|NCT02373202|O2|Outcome|Sarilumab 200 mg q2w + DMARDs|Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37613|NCT02373202|O1|Outcome|Sarilumab 150 mg q2w + DMARDs|Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37614|NCT02373202|E4|Reported Event|Sarilumab 200 mg q2w Monotherapy|Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
37615|NCT02373202|E3|Reported Event|Sarilumab 150 mg q2w Monotherapy|Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
37616|NCT02373202|E2|Reported Event|Sarilumab 200 mg q2w + DMARDs|Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37617|NCT02373202|E1|Reported Event|Sarilumab 150 mg q2w + DMARDs|Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
37618|NCT02372344|B1|Baseline|AZD0585|All subjects received a single oral dose of 4 g AZD0585 on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions. Each dose was administered on Day 1 of each separate treatment period: Period 1=Visit 2; Period 2=Visit 3; Period 3=Visit 4.
37619|NCT02372344|P3|Participant Flow|Sequence CAB|"Subjects randomized to treatment sequence CAB: C=after meal / A=fasting / B=before meal.~Following an overnight fast of at least 10 hours, a single oral dose of 4 g AZD0585 was administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions."
37620|NCT02372344|P2|Participant Flow|Sequence BCA|"Subjects randomized to treatment sequence BCA: B=before meal / C=after meal / A=fasting.~Following an overnight fast of at least 10 hours, a single oral dose of 4 g AZD0585 was administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions."
37621|NCT02372344|P1|Participant Flow|Sequence ABC|"Subjects randomized to treatment sequence ABC: A=fasting / B=before meal / C=after meal.~Following an overnight fast of at least 10 hours, a single oral dose of 4 g AZD0585 was administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions."
37622|NCT02372344|O3|Outcome|After Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake).
37623|NCT02372344|O2|Outcome|Before Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered before consumption of a low calorie, low-fat breakfast (within 30 minutes before starting food intake).
37624|NCT02372344|O1|Outcome|Fasting|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered at the end of a 10-hour fast.
37625|NCT02372344|O3|Outcome|After Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake).
37626|NCT02372344|O2|Outcome|Before Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered before consumption of a low calorie, low-fat breakfast (within 30 minutes before starting food intake).
37627|NCT02372344|O1|Outcome|Fasting|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered at the end of a 10-hour fast.
37628|NCT02372344|O3|Outcome|After Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake).
37629|NCT02372344|O2|Outcome|Before Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered before consumption of a low calorie, low-fat breakfast (within 30 minutes before starting food intake).
37630|NCT02372344|O1|Outcome|Fasting|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered at the end of a 10-hour fast.
37631|NCT02372344|E3|Reported Event|After Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake).
37632|NCT02372344|E2|Reported Event|Before Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered before consumption of a low calorie, low-fat breakfast (within 30 minutes before starting food intake).
37633|NCT02372344|E1|Reported Event|Fasting|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered at the end of a 10-hour fast.
37634|NCT02372097|B3|Baseline|Total|Total of all reporting groups
37635|NCT02372097|B2|Baseline|SYR-472 50 mg + SYR-472 25 mg|SYR-472 50 mg, 1 tablet, orally, on Day 1 of the first intervention period (8 days), followed by at least 13 days washout period, followed by SYR-472 25 mg, 2 tablets, orally on Day 1 of the second intervention period (8 days).
37636|NCT02372097|B1|Baseline|SYR-472 25 mg + SYR-472 50 mg|SYR-472 25 mg, 2 tablets, orally, on Day 1 of the first intervention period (8 days), followed by at least 13 days washout period, followed by SYR-472 50 mg, tablet, orally on Day 1 of the second intervention period (8 days).
37637|NCT02372097|P2|Participant Flow|SYR-472 50 mg + SYR-472 25 mg|SYR-472 50 mg, 1 tablet, orally, on Day 1 of the first intervention period (8 days), followed by at least 13 days washout period, followed by SYR-472 25 mg, 2 tablets, orally on Day 1 of the second intervention period (8 days).
37638|NCT02372097|P1|Participant Flow|SYR-472 25 mg + SYR-472 50 mg|SYR-472 25 mg, 2 tablets, orally, on Day 1 of the first intervention period (8 days), followed by at least 13 days washout period, followed by SYR-472 50 mg, tablet, orally on Day 1 of the second intervention period (8 days).
37639|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
37640|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
37641|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
37642|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
37643|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
37644|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
37645|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
37646|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
37647|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
37648|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
37649|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
37650|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
37651|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
37652|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
37653|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
37654|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
37655|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
37656|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
37657|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
37658|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
37659|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
37660|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
37661|NCT02372097|E2|Reported Event|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
37662|NCT02372097|E1|Reported Event|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
37663|NCT02372071|B1|Baseline|Preterm, Late Preterm and Term Newborns|The study population will consist of preterm, late preterm and term newborns (infants >=24 weeks gestational age)
37664|NCT02372071|P1|Participant Flow|Preterm, Late Preterm and Term Newborns|The study population will consist of preterm, late preterm and term newborns (infants >=24 weeks gestational age)
37665|NCT02372071|O2|Outcome|Total Serum Bilirubin (TSB)|The study population will consist of preterm, late preterm and term newborns (infants >=24 weeks gestational age) measured routinely for total serum bilirubin
37666|NCT02372071|O1|Outcome|BiliCare TcB Average|"The study population will consist of preterm, late preterm and term newborns (infants >=24 weeks gestational age) measured with one BiliCare TcB device without an infection control tip and with one BiliCare TcB device with an infection control tip.~This is the average of both devices"
37667|NCT02372071|E1|Reported Event|Preterm, Late Preterm and Term Newborns|The study population will consist of preterm, late preterm and term newborns (infants >=24 weeks gestational age)
37668|NCT02372058|B1|Baseline|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
37669|NCT02372058|P1|Participant Flow|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
37670|NCT02372058|O3|Outcome|Total Serum Bilirubin (TSB)|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured routinely for total serum bilirubin by diazo method.
37671|NCT02372058|O2|Outcome|JM103 TcB|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with the JM103 TcB device
37672|NCT02372058|O1|Outcome|BiliCare TcB Average|"The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with one BiliCare TcB device without an infection control tip and with one BiliCare TcB device with an infection control tip.~This is the average of both devices"
37673|NCT02372058|E1|Reported Event|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
37674|NCT02371876|B1|Baseline|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
40013|NCT02357940|E2|Reported Event|Babies|Babies - 1% Colloidal Oatmeal Balm
37675|NCT02371876|P1|Participant Flow|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
37676|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
37677|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
37678|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood."
37679|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Study staff tested subject venous blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. BG results were compared to reference method results obtained from subject venous plasma."
37680|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Study staff tested subject fingerstick blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood."
37681|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary palm blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood."
37682|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood."
37683|NCT02371876|E1|Reported Event|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
37684|NCT02371850|B1|Baseline|Nicoderm Patch First, Then Aveva Patch|Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
37685|NCT02371850|P1|Participant Flow|Nicoderm Patch First, Then Aveva Patch|Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
37686|NCT02371850|O1|Outcome|Nicoderm Patch First, Then Aveva Patch|Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
37687|NCT02371850|O1|Outcome|Nicoderm Patch First, Then Aveva Patch|Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
37688|NCT02371850|E1|Reported Event|Nicoderm Patch First, Then Aveva Patch|Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
37689|NCT02371759|B9|Baseline|Total|Total of all reporting groups
37690|NCT02371759|B8|Baseline|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
38141|NCT02370602|E1|Reported Event|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
37691|NCT02371759|B7|Baseline|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37692|NCT02371759|B6|Baseline|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37693|NCT02371759|B5|Baseline|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37694|NCT02371759|B4|Baseline|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37695|NCT02371759|B3|Baseline|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37696|NCT02371759|B2|Baseline|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37697|NCT02371759|B1|Baseline|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37698|NCT02371759|P8|Participant Flow|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37699|NCT02371759|P7|Participant Flow|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37700|NCT02371759|P6|Participant Flow|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37701|NCT02371759|P5|Participant Flow|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37702|NCT02371759|P4|Participant Flow|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37703|NCT02371759|P3|Participant Flow|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37704|NCT02371759|P2|Participant Flow|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37705|NCT02371759|P1|Participant Flow|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37706|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37707|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37708|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37709|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37710|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37711|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37712|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37713|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37714|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37715|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
38142|NCT02370537|B4|Baseline|Total|Total of all reporting groups
37716|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37717|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37718|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37719|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37720|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37721|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37722|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37723|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37724|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37725|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37726|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37727|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37728|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37729|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37730|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37731|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37732|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37733|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37734|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37735|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37736|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37737|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37738|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37739|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37740|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
38215|NCT02370407|O1|Outcome|Laparoscopic Group|Training on laparoscopic platform resulted in improved performance on laparoscopic and robotic task
37741|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37742|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37743|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37744|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37745|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37746|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37747|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37748|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37749|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37750|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37751|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37752|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37753|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37754|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37755|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37756|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37757|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37758|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37759|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37760|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37761|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37762|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37763|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37764|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37765|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
38216|NCT02370407|O2|Outcome|Robotic Group|Training on robotic platform resulted in improved performance on laparoscopic and robotic task
37766|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37767|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37768|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37769|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37770|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37771|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37772|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37773|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37774|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37775|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37776|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37777|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37778|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37779|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37780|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37781|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37782|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37783|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37784|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37785|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37786|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37787|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37788|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37789|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37790|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
38217|NCT02370407|O1|Outcome|Laparoscopic Group|Training on laparoscopic platform resulted in improved performance on laparoscopic and robotic task
37791|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37792|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37793|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37794|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37795|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37796|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37797|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37798|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37799|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37800|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37801|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37802|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37803|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37804|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37805|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37806|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37807|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37808|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37809|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37810|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37811|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37812|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37813|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37814|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37815|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
38218|NCT02370407|O2|Outcome|Robotic Group|Training on robotic platform resulted in improved performance on laparoscopic and robotic task
37816|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37817|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37818|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37819|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37820|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37821|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37822|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37823|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37824|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37825|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37826|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37827|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37828|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37829|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37830|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37831|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37832|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37833|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37834|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37835|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37836|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37837|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37838|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37839|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37840|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
38219|NCT02370407|O1|Outcome|Laparoscopic Group|Training on laparoscopic platform resulted in improved performance on laparoscopic and robotic task
37841|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37842|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37843|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37844|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37845|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37846|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37847|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37848|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37849|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37850|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37851|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37852|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37853|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37854|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37855|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37856|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37857|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37858|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37859|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37860|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37861|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37862|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37863|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37864|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37865|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
38220|NCT02370407|O2|Outcome|Robotic Task|10 repetitions on the robotic task
38221|NCT02370407|O1|Outcome|Laparoscopic|10 repetitions on the laparoscopic task
37866|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37867|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37868|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37869|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37870|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37871|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37872|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37873|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37874|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37875|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37876|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37877|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37878|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37879|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37880|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37881|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37882|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37883|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37884|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37885|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37886|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37887|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37888|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37889|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37890|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
38222|NCT02370407|O2|Outcome|Robotic Group|Training on robotic platform resulted in improved performance on laparoscopic and robotic task
37891|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37892|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37893|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37894|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37895|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37896|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37897|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37898|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37899|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37900|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37901|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37902|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37903|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37904|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37905|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37906|NCT02371759|E8|Reported Event|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37907|NCT02371759|E7|Reported Event|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37908|NCT02371759|E6|Reported Event|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37909|NCT02371759|E5|Reported Event|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37910|NCT02371759|E4|Reported Event|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37911|NCT02371759|E3|Reported Event|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
37912|NCT02371759|E2|Reported Event|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37913|NCT02371759|E1|Reported Event|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
37914|NCT02371616|B3|Baseline|Total|Total of all reporting groups
37915|NCT02371616|B2|Baseline|Comparator Dentifrice|Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate.
37916|NCT02371616|B1|Baseline|Test Dentifrice|Test dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium fluoride.
37917|NCT02371616|P2|Participant Flow|Comparator Dentifrice|Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate.
40114|NCT02357459|O1|Outcome|FX006 32mg|FX006: Single 5 mL IA injection
37918|NCT02371616|P1|Participant Flow|Test Dentifrice|Test dentifrice containing 5% weight by weight (w/w) calcium sodium phosphosilicate and 1426 parts per million (ppm) fluoride as sodium fluoride.
37919|NCT02371616|O2|Outcome|Comparator Dentifrice|Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate.
37920|NCT02371616|O1|Outcome|Test Dentifrice|Test dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium fluoride.
37921|NCT02371616|O2|Outcome|Comparator Dentifrice|Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate.
37922|NCT02371616|O1|Outcome|Test Dentifrice|Test dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium fluoride.
37923|NCT02371616|O2|Outcome|Comparator Dentifrice|Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate.
37924|NCT02371616|O1|Outcome|Test Dentifrice|Test dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium fluoride.
37925|NCT02371616|O2|Outcome|Comparator Dentifrice|Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate.
37926|NCT02371616|O1|Outcome|Test Dentifrice|Test dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium fluoride.
37927|NCT02371616|E2|Reported Event|Comparator Dentifrice|Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate.
37928|NCT02371616|E1|Reported Event|Test Dentifrice|Test dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium fluoride.
37929|NCT02370914|B1|Baseline|Diagnostic Device - Nautilus NeuroWave|"Nautilus NeuroWave diagnostic device. Recordings were evaluated by a Jan Medical concussion algorithm .~Nautilus NeuroWaveTM System: Recording of subjects with Nautilus NeuroWave diagnostic device"
37930|NCT02370914|P1|Participant Flow|Diagnostic Device - Nautilus NeuroWave|"Nautilus NeuroWave diagnostic device. Recordings were evaluated by a Jan Medical concussion algorithm .~Nautilus NeuroWaveTM System: Recording of subjects with Nautilus NeuroWave diagnostic device"
37931|NCT02370914|O1|Outcome|Diagnostic Device - Nautilus NeuroWave|"Nautilus NeuroWave diagnostic device. Recordings were evaluated by a Jan Medical concussion algorithm .~Nautilus NeuroWaveTM System: Recording of subjects with Nautilus NeuroWave diagnostic device"
37932|NCT02370914|E1|Reported Event|Diagnostic Device - Nautilus NeuroWave|"Nautilus NeuroWave diagnostic device. Recordings were evaluated by a Jan Medical concussion algorithm .~Nautilus NeuroWaveTM System: Recording of subjects with Nautilus NeuroWave diagnostic device"
37933|NCT02370667|B4|Baseline|Total|Total of all reporting groups
37934|NCT02370667|B3|Baseline|Meditation Control (M)|"The participants in this arm will be asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. This will take place at an alternate yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group will be offered a free exercise pass following completion of the study.~Meditation Control (M): A meditation program acting as a control will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis."
37935|NCT02370667|B2|Baseline|Traditional Exercise (TE)|"The participants in this arm will be prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program will include 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants will be asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers will be available during all class times for program completion and progression.~Traditional Exercise (TE): A traditional exercise program for people with knee OA will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis."
37936|NCT02370667|B1|Baseline|Biomechanical Exercise (BE)|"The participants in this arm will be asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times will be offered per week. These classes will include a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements will be obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes will include clinical mobility; muscle and fat volumes, and cartilage morphology using MRI; pain; isometric leg strength; cardiovascular fitness; and gait analysis.~Biomechanical Exercise (BE): A biomechanical exercise program shown to decrease joint loading will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis."
37937|NCT02370667|P3|Participant Flow|Meditation Control (M)|"The participants in this arm will be asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. This will take place at an alternate yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group will be offered a free exercise pass following completion of the study.~Meditation Control (M): A meditation program acting as a control will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis."
37938|NCT02370667|P2|Participant Flow|Traditional Exercise (TE)|"The participants in this arm will be prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program will include 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants will be asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers will be available during all class times for program completion and progression.~Traditional Exercise (TE): A traditional exercise program for people with knee OA will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis."
38223|NCT02370407|O1|Outcome|Laparoscopic Group|Training on laparoscopic platform resulted in improved performance on laparoscopic and robotic task
37939|NCT02370667|P1|Participant Flow|Biomechanical Exercise (BE)|"The participants in this arm will be asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times will be offered per week. These classes will include a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements will be obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes will include clinical mobility; muscle and fat volumes, and cartilage morphology using MRI; pain; isometric leg strength; cardiovascular fitness; and gait analysis.~Biomechanical Exercise (BE): A biomechanical exercise program shown to decrease joint loading will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis."
37940|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37941|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37942|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37943|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37944|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37945|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37946|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37947|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37948|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37949|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37950|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
38224|NCT02370407|O2|Outcome|Robotic|10 repetitions on robotic task
38225|NCT02370407|O1|Outcome|Laparoscopic|10 repetitions on laparoscopic task
37951|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37952|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37953|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37954|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37955|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37956|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37957|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37958|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37959|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37960|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37961|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37962|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37963|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
38226|NCT02370407|O2|Outcome|Robotic|10 repetitions on robotic task
38227|NCT02370407|O1|Outcome|Laparoscopic|10 repetitions on laparoscopic task
37964|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37965|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37966|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37967|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37968|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37969|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37970|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37971|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37972|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37973|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37974|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37975|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37976|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37977|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37978|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37979|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37980|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37981|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37982|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37983|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37984|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37985|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37986|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37987|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37988|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37989|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37990|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37991|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37992|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37993|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37994|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37995|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37996|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37997|NCT02370667|E3|Reported Event|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37998|NCT02370667|E2|Reported Event|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
37999|NCT02370667|E1|Reported Event|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
38000|NCT02370615|B3|Baseline|Total|Total of all reporting groups
38001|NCT02370615|B2|Baseline|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, and Digoxin 0.25 mg, tablet, orally, once on Day 1 and 7, followed by TAK-272 80 mg, tablet, orally, once on Day 3 to 8.
38002|NCT02370615|B1|Baseline|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 milligram (mg), tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
38003|NCT02370615|P2|Participant Flow|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, and Digoxin 0.25 mg, tablet, orally, once on Day 1 and 7, followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
38004|NCT02370615|P1|Participant Flow|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 milligram (mg), tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
38005|NCT02370615|O1|Outcome|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 1 and 7, followed by Digoxin 0.25 mg, tablet, orally once on Day 1 and 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
38006|NCT02370615|O2|Outcome|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 1 and 7, followed by Digoxin 0.25 mg, tablet, orally once on Day 1 and 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
38228|NCT02370407|O2|Outcome|Robotic Group|Training on robotic platform resulted in improved performance on laparoscopic and robotic task
38007|NCT02370615|O1|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
38008|NCT02370615|O2|Outcome|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 1 and 7, followed by Digoxin 0.25 mg, tablet, orally once on Day 1 and 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
38009|NCT02370615|O1|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
38010|NCT02370615|O2|Outcome|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 1 and 7, followed by Digoxin 0.25 mg, tablet, orally once on Day 1 and 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
38011|NCT02370615|O1|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
38012|NCT02370615|O2|Outcome|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 1 and 7, followed by Digoxin 0.25 mg, tablet, orally once on Day 1 and 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
38013|NCT02370615|O1|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
38014|NCT02370615|O2|Outcome|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 1 and 7, followed by Digoxin 0.25 mg, tablet, orally once on Day 1 and 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
38015|NCT02370615|O1|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
38016|NCT02370615|O2|Outcome|Cohort 2: Midazolam + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 7, followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
38017|NCT02370615|O1|Outcome|Cohort 2: Midazolam|Midazolam 2 mg, syrup, orally, once on Day 1.
38018|NCT02370615|O2|Outcome|Cohort 2: Midazolam + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 7, followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
38019|NCT02370615|O1|Outcome|Cohort 2: Midazolam|Midazolam 2 mg, syrup, orally, once on Day 1.
38020|NCT02370615|O2|Outcome|Cohort 2: Midazolam + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 7, followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
38021|NCT02370615|O1|Outcome|Cohort 2: Midazolam|Midazolam 2 mg, syrup, orally, once on Day 1.
38022|NCT02370615|O2|Outcome|Cohort 2: Digoxin + TAK-272|Digoxin 0.25 mg, tablet, orally once on Day 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
38023|NCT02370615|O1|Outcome|Cohort 2: Digoxin|Digoxin 0.25 mg, tablet, orally once on Day 1 and 7.
38024|NCT02370615|O2|Outcome|Cohort 2: Digoxin + TAK-272|Digoxin 0.25 mg, tablet, orally once on Day 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
38025|NCT02370615|O1|Outcome|Cohort 2: Digoxin|Digoxin 0.25 mg, tablet, orally once on Day 1 and 7.
38026|NCT02370615|O2|Outcome|Cohort 2: Digoxin + TAK-272|Digoxin 0.25 mg, tablet, orally once on Day 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
38027|NCT02370615|O1|Outcome|Cohort 2: Digoxin|Digoxin 0.25 mg, tablet, orally once on Day 1 and 7.
38028|NCT02370615|O2|Outcome|Cohort 2: Digoxin + TAK-272|Digoxin 0.25 mg, tablet, orally once on Day 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
38029|NCT02370615|O1|Outcome|Cohort 2: Digoxin|Digoxin 0.25 mg, tablet, orally once on Day 1 and 7.
38030|NCT02370615|O2|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
38031|NCT02370615|O1|Outcome|Cohort 1: TAK-272|TAK-272 40 mg, tablet, orally, once on Day 1.
38032|NCT02370615|O2|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
38033|NCT02370615|O1|Outcome|Cohort 1: TAK-272|TAK-272 40 mg, tablet, orally, once on Day 1.
38034|NCT02370615|O2|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
38035|NCT02370615|O1|Outcome|Cohort 1: TAK-272|TAK-272 40 mg, tablet, orally, once on Day 1.
38036|NCT02370615|O2|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
38037|NCT02370615|O1|Outcome|Cohort 1: TAK-272|TAK-272 40 mg, tablet, orally, once on Day 1.
38038|NCT02370615|E2|Reported Event|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, and Digoxin 0.25 mg, tablet, orally, once on Day 1 and 7, followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
38039|NCT02370615|E1|Reported Event|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 milligram (mg), tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
38040|NCT02370602|B7|Baseline|Total|Total of all reporting groups
38041|NCT02370602|B6|Baseline|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
38042|NCT02370602|B5|Baseline|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38229|NCT02370407|O1|Outcome|Laparoscopic Group|Training on laparoscopic platform resulted in improved performance on laparoscopic and robotic task
38043|NCT02370602|B4|Baseline|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
38044|NCT02370602|B3|Baseline|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38045|NCT02370602|B2|Baseline|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38046|NCT02370602|B1|Baseline|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
38047|NCT02370602|P6|Participant Flow|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
38048|NCT02370602|P5|Participant Flow|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38049|NCT02370602|P4|Participant Flow|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
38050|NCT02370602|P3|Participant Flow|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38051|NCT02370602|P2|Participant Flow|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38052|NCT02370602|P1|Participant Flow|[^11C]T-773 Only|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
38053|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38054|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
38055|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38056|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38057|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38058|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
38059|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38060|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38061|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
38062|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38063|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
38064|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38065|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38066|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
38067|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38068|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
38069|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38070|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38071|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
38072|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38073|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
38074|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38075|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38076|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
38077|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38078|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
38079|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38080|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38081|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
38082|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38083|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
38084|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38085|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38086|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
38087|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38088|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
38089|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
53852|NCT02248675|B3|Baseline|Total|Total of all reporting groups
38090|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38091|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
38092|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38093|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
38094|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38095|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38096|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
38097|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38098|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
38099|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38100|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38101|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
38102|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38103|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
38104|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38105|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38106|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
38107|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38108|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
38109|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38110|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38111|NCT02370602|O6|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
38112|NCT02370602|O5|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38139|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38113|NCT02370602|O4|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
38114|NCT02370602|O3|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38115|NCT02370602|O2|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38116|NCT02370602|O1|Outcome|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
38117|NCT02370602|O6|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
38118|NCT02370602|O5|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38119|NCT02370602|O4|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
38120|NCT02370602|O3|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38121|NCT02370602|O2|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38122|NCT02370602|O1|Outcome|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
38123|NCT02370602|O6|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
38124|NCT02370602|O5|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38125|NCT02370602|O4|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
38126|NCT02370602|O3|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38127|NCT02370602|O2|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38128|NCT02370602|O1|Outcome|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
38129|NCT02370602|O2|Outcome|TAK-063|TAK-063 3 to 1000 mg, tablets, orally, once, on Day 1.
38130|NCT02370602|O1|Outcome|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
38131|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38132|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
38133|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38134|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38135|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
38136|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38137|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
38138|NCT02370602|O2|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
38143|NCT02370537|B3|Baseline|Normal FEC (EPANOVA® and OMACOR®)|Patients had normal levels (≥200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function.
38144|NCT02370537|B2|Baseline|Intermediate FEC (EPANOVA® and OMACOR®)|Patients had intermediate levels (≥100 to <200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function.
38145|NCT02370537|B1|Baseline|Low FEC (EPANOVA® and OMACOR®)|Patients had low levels (<100 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function.
38146|NCT02370537|P3|Participant Flow|Normal FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially TGs and FEC as a measure of pancreatic exocrine function in the study population. Patients in the Normal FEC group were determined to have FEC levels ≥200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B. In Part B, study treatment was administered at Visit 4 and Visit 7 with a randomised crossover design to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38147|NCT02370537|P2|Participant Flow|Intermediate FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially TGs and FEC as a measure of pancreatic exocrine function in the study population. Patients in the Intermediate FEC group were determined to have FEC levels ≥100 mcg/g to <200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B. In Part B, study treatment was administered at Visit 4 and Visit 7 with a randomised crossover design to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38148|NCT02370537|P1|Participant Flow|Low FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially triglycerides (TGs) and faecal elastase-1 concentration (FEC) as a measure of pancreatic exocrine function in the study population. Patients in the Low FEC group were determined to have FEC levels <100 microgram per gram (mcg/g). No treatment was administered in Part A which was a recruitment phase for Part B. In Part B, study treatment was administered at Visit 4 and Visit 7 with a randomised crossover design to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38149|NCT02370537|O6|Outcome|Normal FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38150|NCT02370537|O5|Outcome|Normal FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38151|NCT02370537|O4|Outcome|Intermediate FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38152|NCT02370537|O3|Outcome|Intermediate FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38153|NCT02370537|O2|Outcome|Low FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38154|NCT02370537|O1|Outcome|Low FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38155|NCT02370537|O6|Outcome|Normal FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38156|NCT02370537|O5|Outcome|Normal FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38157|NCT02370537|O4|Outcome|Intermediate FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38158|NCT02370537|O3|Outcome|Intermediate FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38327|NCT02369796|O2|Outcome|TAK-448 0.1 µg Twice Weekly|TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
38159|NCT02370537|O2|Outcome|Low FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38160|NCT02370537|O1|Outcome|Low FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38161|NCT02370537|O6|Outcome|Normal FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38162|NCT02370537|O5|Outcome|Normal FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38163|NCT02370537|O4|Outcome|Intermediate FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38164|NCT02370537|O3|Outcome|Intermediate FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38165|NCT02370537|O2|Outcome|Low FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38166|NCT02370537|O1|Outcome|Low FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38167|NCT02370537|O6|Outcome|Normal FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38168|NCT02370537|O5|Outcome|Normal FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38169|NCT02370537|O4|Outcome|Intermediate FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38170|NCT02370537|O3|Outcome|Intermediate FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38171|NCT02370537|O2|Outcome|Low FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38172|NCT02370537|O1|Outcome|Low FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38173|NCT02370537|O6|Outcome|Normal FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38174|NCT02370537|O5|Outcome|Normal FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38192|NCT02370537|E2|Reported Event|Low FEC (OMACOR®)|Patients had low levels (<100 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of OMACOR® 4 g at Visit 4 were reported for this group.
38175|NCT02370537|O4|Outcome|Intermediate FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38176|NCT02370537|O3|Outcome|Intermediate FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38177|NCT02370537|O2|Outcome|Low FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38178|NCT02370537|O1|Outcome|Low FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38179|NCT02370537|O6|Outcome|Normal FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38180|NCT02370537|O5|Outcome|Normal FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38181|NCT02370537|O4|Outcome|Intermediate FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38182|NCT02370537|O3|Outcome|Intermediate FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38183|NCT02370537|O2|Outcome|Low FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38184|NCT02370537|O1|Outcome|Low FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
38185|NCT02370537|O3|Outcome|Normal FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Normal FEC group were determined to have FEC levels ≥200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
38186|NCT02370537|O2|Outcome|Intermediate FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Intermediate FEC group were determined to have FEC levels ≥100 mcg/g to <200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
38187|NCT02370537|O1|Outcome|Low FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Low FEC group were determined to have FEC levels <100 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
38188|NCT02370537|E6|Reported Event|Normal FEC (OMACOR®)|Patients had normal levels (≥200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of OMACOR® 4 g at Visit 4 were reported for this group.
38189|NCT02370537|E5|Reported Event|Normal FEC (EPANOVA®)|Patients had normal levels (≥200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of EPANOVA® 4 g at Visit 4 were reported for this group.
38190|NCT02370537|E4|Reported Event|Intermediate FEC (OMACOR®)|Patients had intermediate levels (≥100 to <200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of OMACOR® 4 g at Visit 4 were reported for this group.
38191|NCT02370537|E3|Reported Event|Intermediate FEC (EPANOVA®)|Patients had intermediate levels (≥100 to <200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of EPANOVA® 4 g at Visit 4 were reported for this group.
38214|NCT02370407|O2|Outcome|Robotic Group|Training on robotic platform resulted in improved performance on laparoscopic and robotic task
56308|NCT02230670|P2|Participant Flow|Placebo|"Placebo BID~Placebo"
38193|NCT02370537|E1|Reported Event|Low FEC (EPANOVA®)|Patients had low levels (<100 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of EPANOVA® 4 g at Visit 4 were reported for this group.
38194|NCT02370420|B3|Baseline|Total|Total of all reporting groups
38195|NCT02370420|B2|Baseline|Triple Application of PRP|"Patients will be applied a triple application of platelet-rich plasma for knee osteoarthritis, with a interval of two weeks between each, and will be given rehabilitation exercises at home~Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections~rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home"
38196|NCT02370420|B1|Baseline|Unique Application of PRP|"Patients will be applied a unique application of platelet-rich plasma for knee osteoarthritis, and will be given rehabilitation exercises at home~Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections~rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home"
38197|NCT02370420|P2|Participant Flow|Triple Application of PRP|"Patients will be applied a triple application of platelet-rich plasma for knee osteoarthritis, with a interval of two weeks between each, and will be given rehabilitation exercises at home~Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections~rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home"
38198|NCT02370420|P1|Participant Flow|Unique Application of PRP|"Patients will be applied a unique application of platelet-rich plasma for knee osteoarthritis, and will be given rehabilitation exercises at home~Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections~rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home"
38199|NCT02370420|O2|Outcome|Triple Application of PRP|"Patients will be applied a triple application of platelet-rich plasma for knee osteoarthritis, with a interval of two weeks between each, and will be given rehabilitation exercises at home~Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections~rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home"
38200|NCT02370420|O1|Outcome|Unique Application of PRP|"Patients will be applied a unique application of platelet-rich plasma for knee osteoarthritis, and will be given rehabilitation exercises at home~Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections~rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home"
38201|NCT02370420|O2|Outcome|Triple Application of PRP|"Patients will be applied a triple application of platelet-rich plasma for knee osteoarthritis, with a interval of two weeks between each, and will be given rehabilitation exercises at home~Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections~rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home"
38202|NCT02370420|O1|Outcome|Unique Application of PRP|"Patients will be applied a unique application of platelet-rich plasma for knee osteoarthritis, and will be given rehabilitation exercises at home~Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections~rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home"
38203|NCT02370420|O2|Outcome|Triple Application of PRP|"Patients will be applied a triple application of platelet-rich plasma for knee osteoarthritis, with a interval of two weeks between each, and will be given rehabilitation exercises at home~Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections~rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home"
38204|NCT02370420|O1|Outcome|Unique Application of PRP|"Patients will be applied a unique application of platelet-rich plasma for knee osteoarthritis, and will be given rehabilitation exercises at home~Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections~rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home"
38205|NCT02370420|E2|Reported Event|Unique Application of PRP|"Patients will be applied a unique application of platelet-rich plasma for knee osteoarthritis, and will be given rehabilitation exercises at home~Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections~rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home"
38206|NCT02370420|E1|Reported Event|Triple Application of PRP|"Patients will be applied a triple application of platelet-rich plasma for knee osteoarthritis, with a interval of two weeks between each, and will be given rehabilitation exercises at home~Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections~rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home"
38207|NCT02370407|B3|Baseline|Total|Total of all reporting groups
38208|NCT02370407|B2|Baseline|Mimic da Vinci Robotic Simulator|"20 study participants will be randomized to perform peg board 1 exercise 10 times on a Mimic da Vinci robotic simulator (Mimic da Vinci Simulator, Intuitive Surgical, Sunnyvale, CA).~Mimic da Vinci robotic simulator: 10 repetitions of practice on Mimic da Vinci robotic simulator."
38209|NCT02370407|B1|Baseline|Laparoscopic Simulator|"20 study participants will be randomized to perform peg transfer task on a laparoscopic simulator 10 times (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA).~a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA): 10 repetitions of practice on laparoscopic simulator."
38210|NCT02370407|P2|Participant Flow|Mimic da Vinci Robotic Simulator|"20 study participants will be randomized to perform peg board 1 exercise 10 times on a Mimic da Vinci robotic simulator (Mimic da Vinci Simulator, Intuitive Surgical, Sunnyvale, CA).~Mimic da Vinci robotic simulator: 10 repetitions of practice on Mimic da Vinci robotic simulator."
38211|NCT02370407|P1|Participant Flow|Laparoscopic Simulator|"20 study participants will be randomized to perform peg transfer task on a laparoscopic simulator 10 times (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA).~a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA): 10 repetitions of practice on laparoscopic simulator."
38212|NCT02370407|O2|Outcome|Robotic Group|Training on robotic platform resulted in improved performance on laparoscopic and robotic task
38213|NCT02370407|O1|Outcome|Laparoscopic Group|Training on laparoscopic platform resulted in improved performance on laparoscopic and robotic task
38230|NCT02370407|E2|Reported Event|Mimic da Vinci Robotic Simulator|"20 study participants will be randomized to perform peg board 1 exercise 10 times on a Mimic da Vinci robotic simulator (Mimic da Vinci Simulator, Intuitive Surgical, Sunnyvale, CA).~Mimic da Vinci robotic simulator: 10 repetitions of practice on Mimic da Vinci robotic simulator."
38231|NCT02370407|E1|Reported Event|Laparoscopic Simulator|"20 study participants will be randomized to perform peg transfer task on a laparoscopic simulator 10 times (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA).~Laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA): 10 repetitions of practice on laparoscopic simulator."
38232|NCT02370394|B3|Baseline|Total|Total of all reporting groups
38233|NCT02370394|B2|Baseline|Control Condition|Control Condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.
38234|NCT02370394|B1|Baseline|ROSE Program|"Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.~ROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV."
38235|NCT02370394|P2|Participant Flow|Control Condition|Control Condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.
38236|NCT02370394|P1|Participant Flow|ROSE Program|"Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.~ROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV."
38237|NCT02370394|O2|Outcome|Control Condition|Control Condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.
38238|NCT02370394|O1|Outcome|ROSE Program|"Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.~ROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV."
38239|NCT02370394|O2|Outcome|Control Condition|Control Condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.
38240|NCT02370394|O1|Outcome|ROSE Program|"Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.~ROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV."
38241|NCT02370394|O2|Outcome|Control Condition|Control Condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.
38242|NCT02370394|O1|Outcome|ROSE Program|"Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.~ROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV."
38243|NCT02370394|O2|Outcome|Control Condition|Control Condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later..
38244|NCT02370394|O1|Outcome|ROSE Program|"Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.~ROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV."
38245|NCT02370394|O2|Outcome|Control Condition|Control Condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.
38246|NCT02370394|O1|Outcome|ROSE Program|"Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.~ROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV."
38247|NCT02370394|E2|Reported Event|Control Condition|Control Condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.
38248|NCT02370394|E1|Reported Event|ROSE Program|"Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.~ROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV."
38249|NCT02370121|B3|Baseline|Total|Total of all reporting groups
38250|NCT02370121|B2|Baseline|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38251|NCT02370121|B1|Baseline|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38252|NCT02370121|P2|Participant Flow|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38253|NCT02370121|P1|Participant Flow|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38254|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38255|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38256|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38257|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38258|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38259|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38328|NCT02369796|O1|Outcome|TAK-448 0.3 µg Twice Weekly|TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
38329|NCT02369796|O3|Outcome|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38260|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38261|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38262|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38263|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38264|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38265|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38266|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38267|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38268|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38269|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38270|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38271|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38272|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38273|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38274|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38275|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38276|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38277|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38278|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38279|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38280|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38281|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38282|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38283|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38284|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38285|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38286|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38287|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38288|NCT02370121|E2|Reported Event|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38289|NCT02370121|E1|Reported Event|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
38290|NCT02369848|B1|Baseline|Shockwave Medical Inc. Peripheral Lithoplasty|The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
38291|NCT02369848|P1|Participant Flow|Shockwave Medical Inc. Peripheral Lithoplasty|The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
38292|NCT02369848|O1|Outcome|Shockwave Medical Inc. Peripheral Lithoplasty|The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
38293|NCT02369848|O1|Outcome|Shockwave Medical Inc. Peripheral Lithoplasty|The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
38294|NCT02369848|O1|Outcome|Shockwave Medical Inc. Peripheral Lithoplasty|The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
38295|NCT02369848|O1|Outcome|Shockwave Medical Inc. Peripheral Lithoplasty|The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
38296|NCT02369848|O1|Outcome|Shockwave Medical Inc. Peripheral Lithoplasty|The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
38297|NCT02369848|O1|Outcome|Shockwave Medical Inc. Peripheral Lithoplasty|The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
38330|NCT02369796|O2|Outcome|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38331|NCT02369796|O1|Outcome|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38332|NCT02369796|O2|Outcome|TAK-448 0.1 µg Twice Weekly|TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
38298|NCT02369848|O1|Outcome|Shockwave Medical Inc. Peripheral Lithoplasty|The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
38299|NCT02369848|O1|Outcome|Shockwave Medical Inc. Peripheral Lithoplasty|The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
38300|NCT02369848|O1|Outcome|Shockwave Medical Inc. Peripheral Lithoplasty|The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
38301|NCT02369848|O1|Outcome|Shockwave Medical Inc. Peripheral Lithoplasty|The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
38302|NCT02369848|O1|Outcome|Shockwave Medical Inc. Peripheral Lithoplasty|The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
38303|NCT02369848|E1|Reported Event|Shockwave Medical Inc. Peripheral Lithoplasty|The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
38304|NCT02369796|B6|Baseline|Total|Total of all reporting groups
38305|NCT02369796|B5|Baseline|TAK-448 0.1 µg Twice Weekly|TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
38306|NCT02369796|B4|Baseline|TAK-448 0.3 µg Twice Weekly|TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
38307|NCT02369796|B3|Baseline|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38308|NCT02369796|B2|Baseline|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38309|NCT02369796|B1|Baseline|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38310|NCT02369796|P5|Participant Flow|TAK-448 0.1 µg Twice Weekly|TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
38311|NCT02369796|P4|Participant Flow|TAK-448 0.3 µg Twice Weekly|TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
38312|NCT02369796|P3|Participant Flow|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38313|NCT02369796|P2|Participant Flow|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38314|NCT02369796|P1|Participant Flow|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38315|NCT02369796|O3|Outcome|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38316|NCT02369796|O2|Outcome|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38317|NCT02369796|O1|Outcome|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38318|NCT02369796|O3|Outcome|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38319|NCT02369796|O2|Outcome|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38320|NCT02369796|O1|Outcome|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38321|NCT02369796|O3|Outcome|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38322|NCT02369796|O2|Outcome|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38323|NCT02369796|O1|Outcome|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38324|NCT02369796|O3|Outcome|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38325|NCT02369796|O2|Outcome|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38326|NCT02369796|O1|Outcome|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
40014|NCT02357940|E1|Reported Event|Adults|Adults - 1% Colloidal Oatmeal Balm
38333|NCT02369796|O1|Outcome|TAK-448 0.3 µg Twice Weekly|TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
38334|NCT02369796|O3|Outcome|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38335|NCT02369796|O2|Outcome|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38336|NCT02369796|O1|Outcome|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38337|NCT02369796|O2|Outcome|TAK-448 0.1 µg Twice Weekly|TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
38338|NCT02369796|O1|Outcome|TAK-448 0.3 µg Twice Weekly|TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
38339|NCT02369796|O3|Outcome|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38340|NCT02369796|O2|Outcome|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38341|NCT02369796|O1|Outcome|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38342|NCT02369796|O2|Outcome|TAK-448 0.1 µg Twice Weekly|TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
38343|NCT02369796|O1|Outcome|TAK-448 0.3 µg Twice Weekly|TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
38344|NCT02369796|O3|Outcome|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38345|NCT02369796|O2|Outcome|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38346|NCT02369796|O1|Outcome|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38347|NCT02369796|E5|Reported Event|TAK-448 0.1 µg Twice Weekly|TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
38348|NCT02369796|E4|Reported Event|TAK-448 0.3 µg Twice Weekly|TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
38349|NCT02369796|E3|Reported Event|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38350|NCT02369796|E2|Reported Event|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38351|NCT02369796|E1|Reported Event|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
38352|NCT02369510|B4|Baseline|Total|Total of all reporting groups
38353|NCT02369510|B3|Baseline|No Epinephrine|"0.2ml saline~No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications"
38354|NCT02369510|B2|Baseline|High-dose Epinephrine|"200micrograms of epinephrine group~High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications"
38355|NCT02369510|B1|Baseline|Low-dose Epinephrine|"100micrograms of epinephrine group~Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications"
38356|NCT02369510|P3|Participant Flow|No Epinephrine|"0.2ml saline~No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications"
38357|NCT02369510|P2|Participant Flow|High-dose Epinephrine|"200micrograms of epinephrine group~High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications"
38358|NCT02369510|P1|Participant Flow|Low-dose Epinephrine|"100micrograms of epinephrine group~Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications"
38359|NCT02369510|O3|Outcome|No Epinephrine|"0.2ml saline~No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications"
38360|NCT02369510|O2|Outcome|High-dose Epinephrine|"200micrograms of epinephrine group~High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications"
38361|NCT02369510|O1|Outcome|Low-dose Epinephrine|"100micrograms of epinephrine group~Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications"
38362|NCT02369510|O3|Outcome|No Epinephrine|"0.2ml saline~No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications"
38363|NCT02369510|O2|Outcome|High-dose Epinephrine|"200micrograms of epinephrine group~High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications"
38364|NCT02369510|O1|Outcome|Low-dose Epinephrine|"100micrograms of epinephrine group~Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications"
38365|NCT02369510|O3|Outcome|No Epinephrine|"0.2ml saline~No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications"
38366|NCT02369510|O2|Outcome|High-dose Epinephrine|"200micrograms of epinephrine group~High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications"
38367|NCT02369510|O1|Outcome|Low-dose Epinephrine|"100micrograms of epinephrine group~Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications"
38368|NCT02369510|O3|Outcome|No Epinephrine|"0.2ml saline~No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications"
38369|NCT02369510|O2|Outcome|High-dose Epinephrine|"200micrograms of epinephrine group~High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications"
38370|NCT02369510|O1|Outcome|Low-dose Epinephrine|"100micrograms of epinephrine group~Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications"
38371|NCT02369510|O3|Outcome|No Epinephrine|"0.2ml saline~No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications"
38372|NCT02369510|O2|Outcome|High-dose Epinephrine|"200micrograms of epinephrine group~High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications"
38373|NCT02369510|O1|Outcome|Low-dose Epinephrine|"100micrograms of epinephrine group~Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications"
38733|NCT02367391|E2|Reported Event|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
38374|NCT02369510|O3|Outcome|No Epinephrine|"0.2ml saline~No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications"
38375|NCT02369510|O2|Outcome|High-dose Epinephrine|"200micrograms of epinephrine group~High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications"
38376|NCT02369510|O1|Outcome|Low-dose Epinephrine|"100micrograms of epinephrine group~Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications"
38377|NCT02369510|O3|Outcome|No Epinephrine|"0.2ml saline~No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications"
38378|NCT02369510|O2|Outcome|High-dose Epinephrine|"200micrograms of epinephrine group~High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications"
38379|NCT02369510|O1|Outcome|Low-dose Epinephrine|"100micrograms of epinephrine group~Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications"
38380|NCT02369510|O3|Outcome|No Epinephrine|"0.2ml saline~No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications"
38381|NCT02369510|O2|Outcome|High-dose Epinephrine|"200micrograms of epinephrine group~High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications"
38382|NCT02369510|O1|Outcome|Low-dose Epinephrine|"100micrograms of epinephrine group~Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications"
38383|NCT02369510|E3|Reported Event|No Epinephrine|"0.2ml saline~No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications"
38384|NCT02369510|E2|Reported Event|High-dose Epinephrine|"200micrograms of epinephrine group~High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications"
38385|NCT02369510|E1|Reported Event|Low-dose Epinephrine|"100micrograms of epinephrine group~Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications"
38386|NCT02369341|B3|Baseline|Total|Total of all reporting groups
38387|NCT02369341|B2|Baseline|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38388|NCT02369341|B1|Baseline|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38389|NCT02369341|P2|Participant Flow|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38390|NCT02369341|P1|Participant Flow|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38391|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38392|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38393|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38394|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38395|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38396|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38397|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38398|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38399|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38400|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38401|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38402|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38403|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38481|NCT02367885|P2|Participant Flow|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38404|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38405|NCT02369341|O4|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_N|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
38406|NCT02369341|O3|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_Y|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
38407|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_N|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
38408|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_Y|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
38409|NCT02369341|O4|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_N|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
38410|NCT02369341|O3|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_Y|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
38411|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_N|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
38412|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_Y|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
38413|NCT02369341|O4|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_N|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
38414|NCT02369341|O3|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_Y|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
38415|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_N|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
38416|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_Y|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
38417|NCT02369341|O4|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_N|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
38418|NCT02369341|O3|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_Y|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
38419|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_N|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
38420|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_Y|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
38421|NCT02369341|O4|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_N|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
38422|NCT02369341|O3|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_Y|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
38423|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_N|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
38424|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_Y|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
38425|NCT02369341|O4|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_N|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
38426|NCT02369341|O3|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_Y|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
38427|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_N|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
38428|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_Y|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
38429|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38430|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38431|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38432|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38433|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38434|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38435|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38436|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38437|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38438|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38439|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38440|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38441|NCT02369341|E2|Reported Event|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged ˃60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38442|NCT02369341|E1|Reported Event|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
38443|NCT02368457|B3|Baseline|Total|Total of all reporting groups
38444|NCT02368457|B2|Baseline|Control Group|No drug treatment
38445|NCT02368457|B1|Baseline|Pentoxifylline and Tocopherol|"Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.~Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum)."
38446|NCT02368457|P2|Participant Flow|Control Group|No drug treatment
38447|NCT02368457|P1|Participant Flow|Pentoxifylline and Tocopherol|"Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.~Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum)."
38448|NCT02368457|O2|Outcome|CONTROL|No drug treatment
38449|NCT02368457|O1|Outcome|Pentoxifylline and Tocopherol|"Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.~Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum)."
38450|NCT02368457|O2|Outcome|Control Group|Standard treatment
38451|NCT02368457|O1|Outcome|Pentoxifylline and Tocopherol|"Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.~Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum)."
38452|NCT02368457|E2|Reported Event|Control Group|Standard treatment
38453|NCT02368457|E1|Reported Event|Pentoxifylline and Tocopherol|"Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.~Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum)."
38454|NCT02368314|B3|Baseline|Total|Total of all reporting groups
38764|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
38765|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
38455|NCT02368314|B2|Baseline|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
38456|NCT02368314|B1|Baseline|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
38457|NCT02368314|P2|Participant Flow|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
38458|NCT02368314|P1|Participant Flow|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
38459|NCT02368314|O2|Outcome|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
38460|NCT02368314|O1|Outcome|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
38461|NCT02368314|O2|Outcome|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
38462|NCT02368314|O1|Outcome|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
38463|NCT02368314|O2|Outcome|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
38464|NCT02368314|O1|Outcome|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
38465|NCT02368314|E2|Reported Event|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
38466|NCT02368314|E1|Reported Event|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
38467|NCT02368093|B3|Baseline|Total|Total of all reporting groups
38468|NCT02368093|B2|Baseline|Placebo|Placebo pills with the same appearance as Detosiv tablets once daily for 6 months.
38469|NCT02368093|B1|Baseline|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide; Detosiv Slow Release® (60mg per tablet, Lotus Pharmaceutical Company, Taipei, Taiwan), 120mg per day with once daily dose taken after breakfast for 6 months
38470|NCT02368093|P2|Participant Flow|Placebo|"Biologic-naïve rheumatoid arthritis patients who fulfilled the 2010 criteria of the American College of Rheumatology for RA were enrolled.~Placebo pills with the same appearance as Dextromethorphan hydrobromide tablets once daily were given for 6 months."
38471|NCT02368093|P1|Participant Flow|Dextromethorphan|"Biologic-naïve rheumatoid arthritis patients who fulfilled the 2010 criteria of the American College of Rheumatology for RA were enrolled.~Dextromethorphan hydrobromide 120mg once daily were given for 6 months."
38472|NCT02368093|O2|Outcome|Placebo|placebo pills with the same appearance as Detosiv tablets.
38473|NCT02368093|O1|Outcome|Dextromethorphan Hydrobromide|"Dextromethorphan hydrobromide; Detosiv Slow Release® (60mg per tablet, Lotus Pharmaceutical Company, Taipei, Taiwan), 120mg per day with once daily dose taken after breakfast]~Dextromethorphan hydrobromide: 120mg per day with once daily dose taken after breakfast for 6 months"
38474|NCT02368093|E2|Reported Event|Placebo|"Biologic-naïve rheumatoid arthritis patients who fulfilled the 2010 criteria of the American College of Rheumatology for RA were enrolled.~Placebo pills with the same appearance as Dextromethorphan hydrobromide tablets once daily were given for 6 months."
38475|NCT02368093|E1|Reported Event|Dextromethorphan|"Biologic-naïve rheumatoid arthritis patients who fulfilled the 2010 criteria of the American College of Rheumatology for RA were enrolled.~Dextromethorphan hydrobromide 120mg once daily were given for 6 months."
38476|NCT02367885|B4|Baseline|Total|Total of all reporting groups
38477|NCT02367885|B3|Baseline|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
38478|NCT02367885|B2|Baseline|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38479|NCT02367885|B1|Baseline|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38480|NCT02367885|P3|Participant Flow|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
38766|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
38767|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
38482|NCT02367885|P1|Participant Flow|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38483|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
38484|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38485|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38486|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
38487|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38488|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38489|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
38490|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38491|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38492|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
38493|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38494|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38495|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
38496|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38497|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38498|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
38499|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38500|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38501|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
38502|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38503|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38504|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
38505|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38506|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38507|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
38508|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38509|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38510|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
38768|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
38769|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
38511|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38512|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38513|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
38514|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38515|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38516|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
38517|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38518|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38519|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
38520|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38521|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38522|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38523|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38524|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38525|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38526|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38527|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38528|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38529|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38530|NCT02367885|O1|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
38531|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38532|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38533|NCT02367885|O1|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
38534|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38535|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38536|NCT02367885|O1|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
38537|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
38538|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38539|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38770|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
40015|NCT02357901|B4|Baseline|Total|Total of all reporting groups
38540|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
38541|NCT02367885|O1|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38542|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38543|NCT02367885|E3|Reported Event|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
38544|NCT02367885|E2|Reported Event|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38545|NCT02367885|E1|Reported Event|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
38546|NCT02367872|B9|Baseline|Total|Total of all reporting groups
38547|NCT02367872|B8|Baseline|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38548|NCT02367872|B7|Baseline|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38549|NCT02367872|B6|Baseline|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38550|NCT02367872|B5|Baseline|Cohort 5R: End-stage Renal Failure (Hemodialysis)|Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (dialysis on Day 1 after dosing). After Part 1 follow-up period, then the same participants received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-dialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day of follow up in Part 1.
38551|NCT02367872|B4|Baseline|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38552|NCT02367872|B3|Baseline|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38553|NCT02367872|B2|Baseline|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38554|NCT02367872|B1|Baseline|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38555|NCT02367872|P8|Participant Flow|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38556|NCT02367872|P7|Participant Flow|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time [PT] or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38557|NCT02367872|P6|Participant Flow|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38558|NCT02367872|P5|Participant Flow|Cohort 5R: End-stage Renal Failure (Hemodialysis)|Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (dialysis on Day 1 after dosing). After Part 1 follow-up period, then the same participants received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-dialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day of follow up in Part 1.
38559|NCT02367872|P4|Participant Flow|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38560|NCT02367872|P3|Participant Flow|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38561|NCT02367872|P2|Participant Flow|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60, less than [<] 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38562|NCT02367872|P1|Participant Flow|Cohort 1R: Normal Renal Function|Participants with normal renal function (estimated glomerular filtration rate [eGFR] greater than or equal to [>=] 90 milliliter per minute per 1.73 square meter [mL/min/1.73 m^2]) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38563|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38564|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38565|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38566|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
38567|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
38568|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38569|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38570|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38571|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38572|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38573|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38574|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38575|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
38576|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
38577|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38578|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38579|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38580|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38771|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
38772|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
38581|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38582|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38583|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38584|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
38585|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
38586|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38587|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38588|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38589|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38590|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38591|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38592|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38593|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
38594|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
38595|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38596|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38597|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38598|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38599|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38641|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38600|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38601|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38602|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
38603|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
38604|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38605|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38606|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38607|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38608|NCT02367872|O1|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
38609|NCT02367872|O8|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38610|NCT02367872|O7|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38611|NCT02367872|O6|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38612|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
38613|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38614|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38615|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38616|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38617|NCT02367872|O7|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38618|NCT02367872|O6|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38619|NCT02367872|O5|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38731|NCT02367391|O2|Outcome|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
38620|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38621|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38622|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38623|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38624|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38625|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38626|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38627|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
38628|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
38629|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38630|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38631|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38632|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38633|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38634|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38635|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38636|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
38637|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
38638|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38639|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38640|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38642|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38643|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38644|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38645|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
38646|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
38647|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38648|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38649|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38650|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38651|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38652|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38653|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38654|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
38655|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
38656|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38657|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38658|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38659|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38660|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38732|NCT02367391|O1|Outcome|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
59191|NCT02210091|O2|Outcome|6 to <12 Years Old|
38661|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38662|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38663|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
38664|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
38665|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38666|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38667|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38668|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38669|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38670|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38671|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38672|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
38673|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
38674|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38675|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38676|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38677|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38678|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38679|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38680|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38681|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
38682|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
38683|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38684|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38685|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38686|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38687|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38688|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38689|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38690|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
38691|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
38692|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38693|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38694|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38695|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38696|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38697|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38698|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38699|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
38700|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
59192|NCT02210091|O1|Outcome|<6 Years Old|
38701|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38702|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38703|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38704|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38705|NCT02367872|E9|Reported Event|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38706|NCT02367872|E8|Reported Event|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
38707|NCT02367872|E7|Reported Event|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38708|NCT02367872|E6|Reported Event|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
38709|NCT02367872|E5|Reported Event|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
38710|NCT02367872|E4|Reported Event|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38711|NCT02367872|E3|Reported Event|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38712|NCT02367872|E2|Reported Event|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38713|NCT02367872|E1|Reported Event|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
38714|NCT02367391|B3|Baseline|Total|Total of all reporting groups
38715|NCT02367391|B2|Baseline|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
38716|NCT02367391|B1|Baseline|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
38717|NCT02367391|P2|Participant Flow|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
38718|NCT02367391|P1|Participant Flow|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
38719|NCT02367391|O2|Outcome|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
38720|NCT02367391|O1|Outcome|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
38721|NCT02367391|O2|Outcome|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
38722|NCT02367391|O1|Outcome|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
38723|NCT02367391|O2|Outcome|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
38724|NCT02367391|O1|Outcome|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
38725|NCT02367391|O2|Outcome|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
38726|NCT02367391|O1|Outcome|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
38727|NCT02367391|O2|Outcome|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
38728|NCT02367391|O1|Outcome|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
38729|NCT02367391|O2|Outcome|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
38730|NCT02367391|O1|Outcome|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
38734|NCT02367391|E1|Reported Event|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
38735|NCT02367170|B3|Baseline|Total|Total of all reporting groups
38736|NCT02367170|B2|Baseline|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
38737|NCT02367170|B1|Baseline|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
38738|NCT02367170|P2|Participant Flow|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
38739|NCT02367170|P1|Participant Flow|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
38740|NCT02367170|O2|Outcome|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
38741|NCT02367170|O1|Outcome|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
38742|NCT02367170|O2|Outcome|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
38743|NCT02367170|O1|Outcome|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
38744|NCT02367170|O2|Outcome|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
38745|NCT02367170|O1|Outcome|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
38746|NCT02367170|E2|Reported Event|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
38747|NCT02367170|E1|Reported Event|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
38748|NCT02367066|B3|Baseline|Total|Total of all reporting groups
38749|NCT02367066|B2|Baseline|Placebo-AZD1981|Sequence Placebo-AZD1981
38750|NCT02367066|B1|Baseline|AZD1981-Placebo|Sequence AZD1981-Placebo
38751|NCT02367066|P2|Participant Flow|Placebo-AZD1981|Sequence Placebo-AZD1981
38752|NCT02367066|P1|Participant Flow|AZD1981-Placebo|Sequence AZD1981-Placebo
38753|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
38754|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
38755|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
38756|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
38757|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
38758|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
38759|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
38760|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
38761|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
38762|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
38763|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
38773|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
38774|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
38775|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
38776|NCT02367066|O1|Outcome|MMTT|Mixed Meal Tolerance Test (MMTT)
38777|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
38778|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
38779|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 infusion)
38780|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
38781|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded glucose and GLP1 infusion)
38782|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
38783|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
38784|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
38785|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
38786|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
38787|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
38788|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
38789|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
38790|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
38791|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
38792|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
38793|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
38794|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
38795|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
38796|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
38797|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
38798|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
38799|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
38800|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
38801|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
38802|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
38803|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
38804|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
38805|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
38806|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
38807|NCT02367066|E2|Reported Event|Placebo|Placebo, oral tablet
38808|NCT02367066|E1|Reported Event|AZD1981|AZD1981, oral tablet
38809|NCT02366936|B1|Baseline|Use of Tortle Midliner|"This study will be an interventional, longitudinal study of 30 preterm infants using the Tortle Midliner.~Tortle Midliner: The Tortle Midliner is a breathable, knit beanie with two support rolls to help position the infant’s head in midline while supine. It can also be worn sidelying or prone. The design includes Velcro adjustments and tabs for nasal cannula and feeding tubes. It is compatible with some ventilation devices, nasal CPAP, X-ray, and bilirubin shades. The beanie is designed to prevent dolichocephaly and provide passive stretch to cervical rotators if head preference has developed. It comes in three sizes and can fit preemies weighing 500 to 2500 g."
38810|NCT02366936|P1|Participant Flow|Use of Tortle Midliner|"This study will be an interventional, longitudinal study of 30 preterm infants using the Tortle Midliner.~Tortle Midliner: The Tortle Midliner is a breathable, knit beanie with two support rolls to help position the infant’s head in midline while supine. It can also be worn sidelying or prone. The design includes Velcro adjustments and tabs for nasal cannula and feeding tubes. It is compatible with some ventilation devices, nasal CPAP, X-ray, and bilirubin shades. The beanie is designed to prevent dolichocephaly and provide passive stretch to cervical rotators if head preference has developed. It comes in three sizes and can fit preemies weighing 500 to 2500 g."
38811|NCT02366936|O1|Outcome|Use of Tortle Midliner|Tortle Midliner: The Tortle Midliner is a breathable, knit beanie with two support rolls to help position the infant’s head in midline while supine. It can also be worn sidelying or prone. The design includes Velcro adjustments and tabs for nasal cannula and feeding tubes. It is compatible with some ventilation devices, nasal CPAP, X-ray, and bilirubin shades. The beanie is designed to prevent dolichocephaly and provide passive stretch to cervical rotators if head preference has developed. It comes in three sizes and can fit preemies weighing 500 to 2500 g.
38812|NCT02366936|O1|Outcome|Use of Tortle Midliner|Tortle Midliner: The Tortle Midliner is a breathable, knit beanie with two support rolls to help position the infant’s head in midline while supine. It can also be worn sidelying or prone. The design includes Velcro adjustments and tabs for nasal cannula and feeding tubes. It is compatible with some ventilation devices, nasal CPAP, X-ray, and bilirubin shades. The beanie is designed to prevent dolichocephaly and provide passive stretch to cervical rotators if head preference has developed. It comes in three sizes and can fit preemies weighing 500 to 2500 g.
38813|NCT02366936|E1|Reported Event|Use of Tortle Midliner|Tortle Midliner: The Tortle Midliner is a breathable, knit beanie with two support rolls to help position the infant’s head in midline while supine. It can also be worn sidelying or prone. The design includes Velcro adjustments and tabs for nasal cannula and feeding tubes. It is compatible with some ventilation devices, nasal CPAP, X-ray, and bilirubin shades. The beanie is designed to prevent dolichocephaly and provide passive stretch to cervical rotators if head preference has developed. It comes in three sizes and can fit preemies weighing 500 to 2500 g.
38814|NCT02366923|B1|Baseline|Overall Participants|"Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table.~stenfilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table~delefilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table"
38815|NCT02366923|P1|Participant Flow|Overall Participants|"Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table.~stenfilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table~delefilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table"
38816|NCT02366923|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
38817|NCT02366923|O1|Outcome|Stenfilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
38818|NCT02366923|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
38819|NCT02366923|O1|Outcome|Stenfilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
38820|NCT02366923|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
38821|NCT02366923|O1|Outcome|Stenfilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
38822|NCT02366923|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
38823|NCT02366923|O1|Outcome|Stenfilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
38824|NCT02366923|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
38825|NCT02366923|O1|Outcome|Stenfilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
38826|NCT02366923|E1|Reported Event|Overall Participants|"Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table.~stenfilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table~delefilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table"
38827|NCT02366910|B1|Baseline|Overall Participants|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye.~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
38828|NCT02366910|P1|Participant Flow|Overall Participants|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye.~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
38829|NCT02366910|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
38830|NCT02366910|O1|Outcome|Omafilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
38831|NCT02366910|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
38832|NCT02366910|O1|Outcome|Omafilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
38833|NCT02366910|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
38834|NCT02366910|O1|Outcome|Omafilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
38835|NCT02366910|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
38836|NCT02366910|O1|Outcome|Omafilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
38837|NCT02366910|E2|Reported Event|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
38838|NCT02366910|E1|Reported Event|Omafilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
38839|NCT02366767|B3|Baseline|Total|Total of all reporting groups
38840|NCT02366767|B2|Baseline|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.~Control: Threshold suspend"
38841|NCT02366767|B1|Baseline|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes~Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
38973|NCT02365519|O2|Outcome|Vehicle|LME636 Vehicle, 1 drop administered topically in each eye TID for 6 weeks
38842|NCT02366767|P2|Participant Flow|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.~Control: Threshold suspend"
38843|NCT02366767|P1|Participant Flow|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes~Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
38844|NCT02366767|O2|Outcome|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.~Control: Threshold suspend"
38845|NCT02366767|O1|Outcome|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes~Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
38846|NCT02366767|O2|Outcome|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.~Control: Threshold suspend"
38847|NCT02366767|O1|Outcome|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes~Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
38848|NCT02366767|O2|Outcome|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.~Control: Threshold suspend"
38849|NCT02366767|O1|Outcome|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes~Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
38850|NCT02366767|E2|Reported Event|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.~Control: Threshold suspend"
38851|NCT02366767|E1|Reported Event|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes~Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
38852|NCT02366689|B4|Baseline|Total|Total of all reporting groups
38853|NCT02366689|B3|Baseline|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
38854|NCT02366689|B2|Baseline|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
38855|NCT02366689|B1|Baseline|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
38856|NCT02366689|P3|Participant Flow|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
38857|NCT02366689|P2|Participant Flow|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
38858|NCT02366689|P1|Participant Flow|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
38859|NCT02366689|O3|Outcome|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
38860|NCT02366689|O2|Outcome|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
38861|NCT02366689|O1|Outcome|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
38974|NCT02365519|O1|Outcome|LME636|LME636 ophthalmic solution, 1 drop (approx. 40 µL; 2.4 mg) administered topically in each eye TID for 6 weeks
38862|NCT02366689|O3|Outcome|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
38863|NCT02366689|O2|Outcome|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
38864|NCT02366689|O1|Outcome|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
38865|NCT02366689|O3|Outcome|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
38866|NCT02366689|O2|Outcome|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
38867|NCT02366689|O1|Outcome|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
38868|NCT02366689|O3|Outcome|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
38869|NCT02366689|O2|Outcome|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
38870|NCT02366689|O1|Outcome|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
38871|NCT02366689|O3|Outcome|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
38872|NCT02366689|O2|Outcome|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
38873|NCT02366689|O1|Outcome|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
38874|NCT02366689|O3|Outcome|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
38875|NCT02366689|O2|Outcome|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
38876|NCT02366689|O1|Outcome|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
38877|NCT02366689|E3|Reported Event|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
38878|NCT02366689|E2|Reported Event|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
38879|NCT02366689|E1|Reported Event|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
38880|NCT02366663|B3|Baseline|Total|Total of all reporting groups
38881|NCT02366663|B2|Baseline|Arm II (BEAM)|"Patients receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)"
38882|NCT02366663|B1|Baseline|Arm I (ZBEAM)|"Patients receive rituximab IV on days -21 and -14, and 90-yttrium ibritumomab tiuxetan IV on day -14. Patients also receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~90-Yttrium Ibritumomab tiuxetan: 0.4 mCi/kg given IV~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)~Rituximab: Given IV"
38883|NCT02366663|P2|Participant Flow|Arm II (BEAM)|"Patients receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)"
38884|NCT02366663|P1|Participant Flow|Arm I (ZBEAM)|"Patients receive rituximab IV on days -21 and -14, and 90-yttrium ibritumomab tiuxetan IV on day -14. Patients also receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~90-Yttrium Ibritumomab tiuxetan: 0.4 mCi/kg given IV~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)~Rituximab: Given IV"
38885|NCT02366663|O2|Outcome|Arm II (BEAM)|"Patients receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)"
38886|NCT02366663|O1|Outcome|Arm I (ZBEAM)|"Patients receive rituximab IV on days -21 and -14, and 90-yttrium ibritumomab tiuxetan IV on day -14. Patients also receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~90-Yttrium Ibritumomab tiuxetan: 0.4 mCi/kg given IV~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)~Rituximab: Given IV"
38887|NCT02366663|O2|Outcome|Arm II (BEAM)|"Patients receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)"
38888|NCT02366663|O1|Outcome|Arm I (ZBEAM)|"Patients receive rituximab IV on days -21 and -14, and 90-yttrium ibritumomab tiuxetan IV on day -14. Patients also receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~90-Yttrium Ibritumomab tiuxetan: 0.4 mCi/kg given IV~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)~Rituximab: Given IV"
38889|NCT02366663|O2|Outcome|Arm II (BEAM)|"Patients receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)"
38890|NCT02366663|O1|Outcome|Arm I (ZBEAM)|"Patients receive rituximab IV on days -21 and -14, and 90-yttrium ibritumomab tiuxetan IV on day -14. Patients also receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~90-Yttrium Ibritumomab tiuxetan: 0.4 mCi/kg given IV~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)~Rituximab: Given IV"
38891|NCT02366663|O2|Outcome|Arm II (BEAM)|"Patients receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)"
38892|NCT02366663|O1|Outcome|Arm I (ZBEAM)|"Patients receive rituximab IV on days -21 and -14, and 90-yttrium ibritumomab tiuxetan IV on day -14. Patients also receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~90-Yttrium Ibritumomab tiuxetan: 0.4 mCi/kg given IV~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)~Rituximab: Given IV"
40102|NCT02357459|O2|Outcome|Placebo|Normal Saline: Single 5 mL IA injection
38893|NCT02366663|O2|Outcome|Arm II (BEAM)|"Patients receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)"
38894|NCT02366663|O1|Outcome|Arm I (ZBEAM)|"Patients receive rituximab IV on days -21 and -14, and 90-yttrium ibritumomab tiuxetan IV on day -14. Patients also receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~90-Yttrium Ibritumomab tiuxetan: 0.4 mCi/kg given IV~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)~Rituximab: Given IV"
38895|NCT02366663|O2|Outcome|Arm II (BEAM)|"Patients receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)"
38896|NCT02366663|O1|Outcome|Arm I (ZBEAM)|"Patients receive rituximab IV on days -21 and -14, and 90-yttrium ibritumomab tiuxetan IV on day -14. Patients also receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~90-Yttrium Ibritumomab tiuxetan: 0.4 mCi/kg given IV~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)~Rituximab: Given IV"
38897|NCT02366663|O2|Outcome|Arm II (BEAM)|"Patients receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)"
38898|NCT02366663|O1|Outcome|Arm I (ZBEAM)|"Patients receive rituximab IV on days -21 and -14, and 90-yttrium ibritumomab tiuxetan IV on day -14. Patients also receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~90-Yttrium Ibritumomab tiuxetan: 0.4 mCi/kg given IV~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)~Rituximab: Given IV"
38899|NCT02366663|O2|Outcome|Arm II (BEAM)|"Patients receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)"
38900|NCT02366663|O1|Outcome|Arm I (ZBEAM)|"Patients receive rituximab IV on days -21 and -14, and 90-yttrium ibritumomab tiuxetan IV on day -14. Patients also receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~90-Yttrium Ibritumomab tiuxetan: 0.4 mCi/kg given IV~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)~Rituximab: Given IV"
38901|NCT02366663|O2|Outcome|Arm II (BEAM)|"Patients receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)"
38902|NCT02366663|O1|Outcome|Arm I (ZBEAM)|"Patients receive rituximab IV on days -21 and -14, and 90-yttrium ibritumomab tiuxetan IV on day -14. Patients also receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~90-Yttrium Ibritumomab tiuxetan: 0.4 mCi/kg given IV~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)~Rituximab: Given IV"
38903|NCT02366663|O2|Outcome|Arm II (BEAM)|"Patients receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)"
38904|NCT02366663|O1|Outcome|Arm I (ZBEAM)|"Patients receive rituximab IV on days -21 and -14, and 90-yttrium ibritumomab tiuxetan IV on day -14. Patients also receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~90-Yttrium Ibritumomab tiuxetan: 0.4 mCi/kg given IV~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)~Rituximab: Given IV"
38927|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
38975|NCT02365519|O2|Outcome|Vehicle|LME636 Vehicle, 1 drop administered topically in each eye TID for 6 weeks
38905|NCT02366663|O2|Outcome|Arm II (BEAM)|"Patients receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)"
38906|NCT02366663|O1|Outcome|Arm I (ZBEAM)|"Patients receive rituximab IV on days -21 and -14, and 90-yttrium ibritumomab tiuxetan IV on day -14. Patients also receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~90-Yttrium Ibritumomab tiuxetan: 0.4 mCi/kg given IV~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)~Rituximab: Given IV"
38907|NCT02366663|E2|Reported Event|Arm II (BEAM)|"Patients receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)"
38908|NCT02366663|E1|Reported Event|Arm I (ZBEAM)|"Patients receive rituximab IV on days -21 and -14, and 90-yttrium ibritumomab tiuxetan IV on day -14. Patients also receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.~90-Yttrium Ibritumomab tiuxetan: 0.4 mCi/kg given IV~Carmustine: Given IV~Etoposide: Given IV~Cytarabine: Given IV~Melphalan: Given IV~Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)~Rituximab: Given IV"
38909|NCT02366637|B1|Baseline|All Participants|All participants who received at least 1 dose of study drug (PF-03715455 or placebo).
38910|NCT02366637|P2|Participant Flow|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
38911|NCT02366637|P1|Participant Flow|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
38912|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
38913|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
38914|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
38915|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
38916|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
38917|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
38918|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
38919|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
38920|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
38921|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
38922|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
38923|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
38924|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
38925|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
38926|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
38928|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
38929|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
38930|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
38931|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
38932|NCT02366637|E2|Reported Event|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
38933|NCT02366637|E1|Reported Event|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
38934|NCT02366338|B4|Baseline|Total|Total of all reporting groups
38935|NCT02366338|B3|Baseline|Group 3|Patients on dabigatran therapy
38936|NCT02366338|B2|Baseline|Group 2|patients on rivaroxaban therapy
38937|NCT02366338|B1|Baseline|Group 1|patients on warfarin therapy
38938|NCT02366338|P3|Participant Flow|Group 3|Patients on dabigatran therapy
38939|NCT02366338|P2|Participant Flow|Group 2|patients on rivaroxaban therapy
38940|NCT02366338|P1|Participant Flow|Group 1|patients on warfarin therapy
38941|NCT02366338|O3|Outcome|Group 3|Patients on dabigatran therapy
38942|NCT02366338|O2|Outcome|Group 2|patients on rivaroxaban therapy
38943|NCT02366338|O1|Outcome|Group 1|patients on warfarin therapy
38944|NCT02366338|E3|Reported Event|Group 3|Patients on dabigatran therapy
38945|NCT02366338|E2|Reported Event|Group 2|patients on rivaroxaban therapy
38946|NCT02366338|E1|Reported Event|Group 1|patients on warfarin therapy
38947|NCT02365714|B1|Baseline|CyberKnife Arm|Two patients were enrolled for CyberKnife. In one patient, the fiducials were unable to be tracked, so she received external beam partial breast irradiation.
38948|NCT02365714|P1|Participant Flow|CyberKnife Arm|This is a single arm study for patients who are eligible for partial breast irradiation.
38949|NCT02365714|O1|Outcome|CyberKnife Arm|This is a single arm study for patients who are eligible for partial breast irradiation.
38950|NCT02365714|O1|Outcome|CyberKnife Arm|This is a single arm study for patients who are eligible for partial breast irradiation.
38951|NCT02365714|O1|Outcome|CyberKnife Arm|This is a single arm study for patients who are eligible for partial breast irradiation.
38952|NCT02365714|E1|Reported Event|Treatment-Radiation|"CyberKnife (CK) Stereotactic Accelerated Partial Breast Irradiation. Adjuvant radiation therapy delivered to the region around the lumpectomy cavity. Patients will receive 30 Gy in 5 fractions over 5-14 days.~CK Stereotactic Accelerated Partial Breast Irradiation: Adjuvant radiation therapy will be delivered to the region of the lumpectomy cavity once daily for 5 treatments over 5-10 days."
38953|NCT02365688|B1|Baseline|Initial Bolus Pre-incision|"Initial pre-incision bolus of 500 cc of fluids with hemodynamic response recorded~Initial bolus pre-incision: Measured hemodynamic response to pre-incision bolus"
38954|NCT02365688|P1|Participant Flow|Initial Bolus Pre-incision|"Initial pre-incision bolus of 500 cc of fluids with hemodynamic response recorded~Initial bolus pre-incision: Measured hemodynamic response to pre-incision bolus"
38955|NCT02365688|O1|Outcome|Initial Bolus Pre-incision|"Initial pre-incision bolus of 500 cc of fluids with hemodynamic response recorded~Initial bolus pre-incision: Measured hemodynamic response to pre-incision bolus"
38956|NCT02365688|E1|Reported Event|Pre-surgical Bolus|Pre-surgical bolus of 500 cc before incision rather than during incision for baseline hemodynamic data
38957|NCT02365519|B3|Baseline|Total|Total of all reporting groups
38958|NCT02365519|B2|Baseline|Vehicle|All subjects randomized and treated with LME636 Vehicle
38959|NCT02365519|B1|Baseline|LME636|All subjects randomized and treated with LME636 ophthalmic solution
38960|NCT02365519|P3|Participant Flow|Vehicle|All subjects exposed to LME636 Vehicle during randomized study treatment
38961|NCT02365519|P2|Participant Flow|LME636|All subjects exposed to LME636 ophthalmic solution during randomized study treatment
38962|NCT02365519|P1|Participant Flow|Vehicle Run-In|All subjects exposed to LME636 Vehicle prior to the initiation of randomized study treatment
38963|NCT02365519|O3|Outcome|Run-In Only|LME636 Vehicle, 1 drop administered topically in each eye TID for 4 weeks with exit prior to start of randomized treatment
38964|NCT02365519|O2|Outcome|Vehicle|LME636 Vehicle, 1 drop administered topically in each eye TID for 6 weeks during randomized study treatment
38965|NCT02365519|O1|Outcome|LME636|LME636 ophthalmic solution, 1 drop (approx. 40 µL; 2.4 mg) administered topically in each eye TID for 6 weeks
38966|NCT02365519|O1|Outcome|LME636|LME636 ophthalmic solution, 1 drop (approx. 40 µL; 2.4 mg) administered topically in each eye TID for 6 weeks
38967|NCT02365519|O2|Outcome|Vehicle|LME636 Vehicle, 1 drop administered topically in each eye TID for 6 weeks
38968|NCT02365519|O1|Outcome|LME636|LME636 ophthalmic solution, 1 drop (approx. 40 µL; 2.4 mg) administered topically in each eye TID for 6 weeks
38969|NCT02365519|O2|Outcome|Vehicle|LME636 Vehicle, 1 drop administered topically in each eye TID for 6 weeks
38970|NCT02365519|O1|Outcome|LME636|LME636 ophthalmic solution, 1 drop (approx. 40 µL; 2.4 mg) administered topically in each eye TID for 6 weeks
38971|NCT02365519|O2|Outcome|Vehicle|LME636 Vehicle, 1 drop administered topically in each eye TID for 6 weeks
38972|NCT02365519|O1|Outcome|LME636|LME636 ophthalmic solution, 1 drop (approx. 40 µL; 2.4 mg) administered topically in each eye TID for 6 weeks
38976|NCT02365519|O1|Outcome|LME636|LME636 ophthalmic solution, 1 drop (approx. 40 µL; 2.4 mg) administered topically in each eye TID for 6 weeks
38977|NCT02365519|O2|Outcome|Vehicle|LME636 Vehicle, 1 drop administered topically in each eye TID for 6 weeks
38978|NCT02365519|O1|Outcome|LME636|LME636 ophthalmic solution, 1 drop (approx. 40 µL; 2.4 mg) administered topically in each eye TID for 6 weeks
38979|NCT02365519|E3|Reported Event|Vehicle|All subjects exposed to LME636 Vehicle during randomized study treatment
38980|NCT02365519|E2|Reported Event|LME636|All subjects exposed to LME636 ophthalmic solution during randomized study treatment
38981|NCT02365519|E1|Reported Event|Vehicle Run-In|All subjects exposed to LME636 Vehicle prior to the initiation of randomized study treatment
38982|NCT02365298|B1|Baseline|All Dispensed Subjects|All subjects that were dispensed a study lens.
38983|NCT02365298|P2|Participant Flow|Nelfilcon A / Etafilcon A|Subjects that were randomized to receive the nelfilcon A lens first, and then to receive the etafilcon A lens second.
38984|NCT02365298|P1|Participant Flow|Etafilcon a /Nelfilcon A|Subjects that were randomized to receive the etafilcon A lens first, and then to receive the nelfilcon A lens second.
38985|NCT02365298|O2|Outcome|Nelfilcon A|Subjects that wore the nelfilcon A lens in either the first or second period of the study.
38986|NCT02365298|O1|Outcome|Etafilcon A|Subjects that wore the etafilcon A lens in either the first or second period of the study.
38987|NCT02365298|O2|Outcome|Nelfilcon A|Subjects that wore the nelfilcon A lens in either the first or second period of the study.
38988|NCT02365298|O1|Outcome|Etafilcon A|Subjects that wore the etafilcon A lens in either the first or second period of the study.
38989|NCT02365298|O2|Outcome|Nelfilcon A|Subjects that wore the nelfilcon A lens in either the first or second period of the study.
38990|NCT02365298|O1|Outcome|Etafilcon A|Subjects that wore the etafilcon A lens in either the first or second period of the study.
38991|NCT02365298|O2|Outcome|Nelfilcon A|Subjects that wore the nelfilcon A lens in either the first or second period of the study.
38992|NCT02365298|O1|Outcome|Etafilcon A|Subjects that wore the etafilcon A lens in either the first or second period of the study.
38993|NCT02365298|O2|Outcome|Nelfilcon A|Subjects that wore the nelfilcon A lens in either the first or second period of the study.
38994|NCT02365298|O1|Outcome|Etafilcon A|Subjects that wore the etafilcon A lens in either the first or second period of the study.
38995|NCT02365298|O2|Outcome|Nelfilcon A|Subjects that wore the nelfilcon A lens in either the first or second period of the study.
38996|NCT02365298|O1|Outcome|Etafilcon A|Subjects that wore the etafilcon A lens in either the first or second period of the study.
38997|NCT02365298|E2|Reported Event|Nelfilcon A|Subjects that wore the nelfilcon A lens in either the first or second period of the study.
38998|NCT02365298|E1|Reported Event|Etafilcon A|Subjects that wore the etafilcon A lens in either the first or second period of the study.
38999|NCT02364778|B3|Baseline|Total|Total of all reporting groups
39000|NCT02364778|B2|Baseline|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
39001|NCT02364778|B1|Baseline|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
39002|NCT02364778|P1|Participant Flow|Provisional Stenting Strategy|Patients with stable coronary artery disease with angiographic main vessel lesion not involving side branch (SB) in whom provisional stenting strategy is planned.
39003|NCT02364778|O2|Outcome|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
39004|NCT02364778|O1|Outcome|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
39005|NCT02364778|O2|Outcome|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
39006|NCT02364778|O1|Outcome|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
39007|NCT02364778|O2|Outcome|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
39008|NCT02364778|O1|Outcome|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
39009|NCT02364778|O2|Outcome|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
39010|NCT02364778|O1|Outcome|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
39011|NCT02364778|E2|Reported Event|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
39012|NCT02364778|E1|Reported Event|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
39013|NCT02364700|B1|Baseline|Interventional Group|This is a single group, interventional pilot study. All participants will receive 6-week hand training on the HOH device. Subjects will receive arm training 3x/week for 6 weeks.
39014|NCT02364700|P1|Participant Flow|Interventional Group|"This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.~Subjects will receive arm training 3x/week for 6 weeks"
39015|NCT02364700|O1|Outcome|Interventional Group|"This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.~Subjects will receive arm training 3x/week for 6 weeks"
39016|NCT02364700|O1|Outcome|Interventional Group|"This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.~Subjects will receive arm training 3x/week for 6 weeks"
39017|NCT02364700|O1|Outcome|Interventional Group|"This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.~Subjects will receive arm training 3x/week for 6 weeks"
39018|NCT02364700|O1|Outcome|Interventional Group|"This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.~Subjects will receive arm training 3x/week for 6 weeks"
39019|NCT02364700|O1|Outcome|Interventional Group|"This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.~Subjects will receive arm training 3x/week for 6 weeks"
39020|NCT02364700|O1|Outcome|Interventional Group|"This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.~Subjects will receive arm training 3x/week for 6 weeks"
39021|NCT02364700|E1|Reported Event|Interventional Group|"This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.~Subjects will receive arm training 3x/week for 6 weeks"
39022|NCT02364180|B1|Baseline|Pyridostigmine Bromide Treatment Group|All subjects investigated were taking pyridostigmine.
39023|NCT02364180|P1|Participant Flow|Pyridostigmine Bromide Treatment Group|pyridostigmine bromide treatment is a single arm. Subjects must be treated with pyridostigmine for at least 6months and must not be treated for myasthenia gravis.
39024|NCT02364180|O1|Outcome|Pyridostigmine Bromide Treatment Group|Subjects taking pyridostigmine bromide for more than 6 months for a condition other than myasthenia gravis
39025|NCT02364180|E1|Reported Event|Pyridostigmine Bromide Treatment Group|In all enrolled subjects (10), who were known pyridostigmine bromide pts that were observed with Electromyography (EMG), there were no adverse events anticipated.
39026|NCT02363933|B1|Baseline|Perampanel + Current Anti-Epileptic Drug|"Primary glioma patients will receive perampanel along with their current AED for a total of 20 weeks. Perampanel will be titrated from 2 mg in weeks 1 and 2 and up to 8 mg daily by week 5 if well tolerated by the patient. They will then receive a maintenance dose of 8 mg per day through 16 weeks. After 16 weeks, subjects will be tapered off perampanel over a 4 week period.~Perampanel: Perampanel is a highly selective non-competitive alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) type glutamate receptor antagonist that has shown efficacy in a randomized phase III study for refractory partial-onset seizures"
39027|NCT02363933|P1|Participant Flow|Perampanel + Current Anti-Epileptic Drug|"Primary glioma patients will receive perampanel along with their current AED for a total of 20 weeks. Perampanel will be titrated from 2 mg in weeks 1 and 2 and up to 8 mg daily by week 5 if well tolerated by the patient. They will then receive a maintenance dose of 8 mg per day through 16 weeks. After 16 weeks, subjects will be tapered off perampanel over a 4 week period.~Perampanel: Perampanel is a highly selective non-competitive alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) type glutamate receptor antagonist that has shown efficacy in a randomized phase III study for refractory partial-onset seizures"
39028|NCT02363933|O1|Outcome|Perampanel + Current Anti-Epileptic Drug|"Primary glioma patients will receive perampanel along with their current AED for a total of 20 weeks. Perampanel will be titrated from 2 mg in weeks 1 and 2 and up to 8 mg daily by week 5 if well tolerated by the patient. They will then receive a maintenance dose of 8 mg per day through 16 weeks. After 16 weeks, subjects will be tapered off perampanel over a 4 week period.~Perampanel: Perampanel is a highly selective non-competitive alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) type glutamate receptor antagonist that has shown efficacy in a randomized phase III study for refractory partial-onset seizures"
39029|NCT02363933|O1|Outcome|Perampanel + Current Anti-Epileptic Drug|"Primary glioma patients will receive perampanel along with their current AED for a total of 20 weeks. Perampanel will be titrated from 2 mg in weeks 1 and 2 and up to 8 mg daily by week 5 if well tolerated by the patient. They will then receive a maintenance dose of 8 mg per day through 16 weeks. After 16 weeks, subjects will be tapered off perampanel over a 4 week period.~Perampanel: Perampanel is a highly selective non-competitive alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) type glutamate receptor antagonist that has shown efficacy in a randomized phase III study for refractory partial-onset seizures"
39030|NCT02363933|E1|Reported Event|Perampanel + Current Anti-Epileptic Drug|"Primary glioma patients will receive perampanel along with their current AED for a total of 20 weeks. Perampanel will be titrated from 2 mg in weeks 1 and 2 and up to 8 mg daily by week 5 if well tolerated by the patient. They will then receive a maintenance dose of 8 mg per day through 16 weeks. After 16 weeks, subjects will be tapered off perampanel over a 4 week period.~Perampanel: Perampanel is a highly selective non-competitive alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) type glutamate receptor antagonist that has shown efficacy in a randomized phase III study for refractory partial-onset seizures"
39031|NCT02363907|B1|Baseline|Single Arm|Subjects acting as their own control,comparing glucose values between CGM and blood glucose meters for %20/20 agreement
39032|NCT02363907|P1|Participant Flow|Single Arm- Performance, Using Blood Glucose Meter Reference|Subjects acting as their own control,comparing glucose values between CGM and blood glucose meters for %20/20 agreement
39033|NCT02363907|O1|Outcome|Single Arm|Subjects as their own control, comparing ISF glucose readings to capillary blood glucose readings, measured by blood glucose meters
39034|NCT02363907|E1|Reported Event|Single Arm,Performance, Using Blood Glucose Meter Reference|Subjects acting as their own control,comparing glucose values between CGM and blood glucose meters for %20/20 agreement
39035|NCT02363478|B1|Baseline|Buspirone|22 out of 30 participants (19 female) completed the study.
39036|NCT02363478|P1|Participant Flow|Buspirone|Participants received buspirone 20 mg/day for 4 weeks
39037|NCT02363478|O1|Outcome|Buspirone|Participants received buspirone 20 mg/day for 4 weeks
39038|NCT02363478|O1|Outcome|Buspirone|Participants received buspirone 20 mg/day for 4 weeks
39039|NCT02363478|O1|Outcome|Buspirone|"4-weeks buspirone administration (20mg) in patients with SSc and esophageal involvement~buspirone: buspirone 10 mg X2 for 4 weeks"
39040|NCT02363478|O1|Outcome|Buspirone|Participants received buspirone 20 mg/day for 4 weeks
39041|NCT02363478|E1|Reported Event|Buspirone|Participants received bouspirone 20 mg/day for 4 weeks
39042|NCT02363439|B1|Baseline|IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk|Subcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 twice weekly per Protocol 8400-401
39043|NCT02363439|P1|Participant Flow|IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk|Subcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401
39044|NCT02363439|O1|Outcome|IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk|Subcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401
39045|NCT02363439|E1|Reported Event|IMO-8400 at 0.6 mg/kg/wk or 1.2 mg/kg 2xwk|Subcutaneous injection of IMO-8400 0.6mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401
39046|NCT02363270|B3|Baseline|Total|Total of all reporting groups
39047|NCT02363270|B2|Baseline|IV Drip Group|"Ketamine medication given via IV Drip. IV Drip is the intervention.~Ketamine: IV Push or or IV Drip"
39048|NCT02363270|B1|Baseline|IV Push Group|"Ketamine medication given via IV Push. IV Push is the intervention.~Ketamine: IV Push or or IV Drip"
39049|NCT02363270|P2|Participant Flow|IV Drip Group|"Ketamine medication given via IV Drip. IV Drip is the intervention.~Ketamine: IV Push or or IV Drip"
39050|NCT02363270|P1|Participant Flow|IV Push Group|"Ketamine medication given via IV Push. IV Push is the intervention.~Ketamine: IV Push or or IV Drip"
40103|NCT02357459|O1|Outcome|FX006 32 mg|FX006: Single 5 mL IA injection
39051|NCT02363270|O2|Outcome|IV Drip Group|"Ketamine medication given via IV Drip. IV Drip is the intervention.~Ketamine: IV Push or or IV Drip"
39052|NCT02363270|O1|Outcome|IV Push Group|"Ketamine medication given via IV Push. IV Push is the intervention.~Ketamine: IV Push or or IV Drip"
39053|NCT02363270|E2|Reported Event|IV Drip Group|"Ketamine medication given via IV Drip. IV Drip is the intervention.~Ketamine: IV Push or or IV Drip"
39054|NCT02363270|E1|Reported Event|IV Push Group|"Ketamine medication given via IV Push. IV Push is the intervention.~Ketamine: IV Push or or IV Drip"
39055|NCT02362412|B1|Baseline|All Study Participants|Participants who received either FK949E 50 mg tablets or FK949E 150 mg tablets once daily. The analysis population was the Full Analysis Set (FAS), which consisted of all participants who received at least one dose of the study drug and who had at least one efficacy measurement after the start of treatment with the study drug.
39056|NCT02362412|P2|Participant Flow|FK949E 150 mg / FK949E 50 mg|Participants who received the 150 mg tablet once daily during Treatment Period II (8 weeks) and 50 mg tablet once daily during Treatment Period III (8 weeks).
39057|NCT02362412|P1|Participant Flow|FK949E 50 mg / FK949E 150 mg|Participants who received the 50 mg tablet once daily during Treatment Period II (8 weeks) and 150 mg tablet once daily during Treatment Period III (8 weeks).
39058|NCT02362412|O4|Outcome|Treatment Period III FK949E 50 mg|Participants who received FK949E 50 mg tablets once daily during Treatment Period III (8 weeks).
39059|NCT02362412|O3|Outcome|Treatment Period III FK949E 150 mg|Participants who received FK949E 150 mg tablets once daily during Treatment Period III (8 weeks).
39060|NCT02362412|O2|Outcome|Treatment Period II FK949E 150 mg|Participants who received FK949E 150 mg tablets once daily during Treatment Period II (8 weeks).
39061|NCT02362412|O1|Outcome|Treatment Period II FK949E 50 mg|Participants who received FK949E 50 mg tablets once daily during Treatment Period II (8 weeks).
39062|NCT02362412|O2|Outcome|FK949E 150 mg Tablets|Participants who received FK949E 150 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
39063|NCT02362412|O1|Outcome|FK949E 50 mg Tablets|Participants who received FK949E 50 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
39064|NCT02362412|O2|Outcome|FK949E 150 mg Tablets|Participants who received FK949E 150 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
39065|NCT02362412|O1|Outcome|FK949E 50 mg Tablets|Participants who received FK949E 50 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
39066|NCT02362412|O2|Outcome|FK949E 150 mg Tablets|Participants who received FK949E 150 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
39067|NCT02362412|O1|Outcome|FK949E 50 mg Tablets|Participants who received FK949E 50 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
39068|NCT02362412|O2|Outcome|FK949E 150 mg Tablets|Participants who received FK949E 150 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
39069|NCT02362412|O1|Outcome|FK949E 50 mg Tablets|Participants who received FK949E 50 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
39070|NCT02362412|O2|Outcome|FK949E 150 mg Tablets|Participants who received FK949E 150 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
39071|NCT02362412|O1|Outcome|FK949E 50 mg Tablets|Participants who received FK949E 50 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
39072|NCT02362412|O2|Outcome|FK949E 150 mg Tablets|Participants who received FK949E 150 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
39073|NCT02362412|O1|Outcome|FK949E 50 mg Tablets|Participants who received FK949E 50 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
39074|NCT02362412|O2|Outcome|FK949E 150 mg Tablets|Participants who received FK949E 150 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
39075|NCT02362412|O1|Outcome|FK949E 50 mg Tablets|Participants who received FK949E 50 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
39076|NCT02362412|O2|Outcome|FK949E 150 mg Tablets|Participants who received FK949E 150 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
39077|NCT02362412|O1|Outcome|FK949E 50 mg Tablets|Participants who received FK949E 50 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
39078|NCT02362412|E4|Reported Event|Treatment Period III FK949E 50 mg|Participants who received FK949E 50 mg tablets once daily during Treatment Period III (8 weeks).
39079|NCT02362412|E3|Reported Event|Treatment Period III FK949E 150 mg|Participants who received FK949E 150 mg tablets once daily during Treatment Period III (8 weeks).
39080|NCT02362412|E2|Reported Event|Treatment Period II FK949E 150 mg|Participants who received FK949E 150 mg tablets once daily duringr Treatment Period II (8 weeks).
39081|NCT02362412|E1|Reported Event|Treatment Period II FK949E 50 mg|Participants who received FK949E 50 mg tablets once daily during Treatment Period II (8 weeks).
39082|NCT02362373|B1|Baseline|Levonorgestrel IUS|"all women in the study underwent placement of the levonorgestrel IUS in an open-label fashion, outcomes were compared before and after placement.~levonorgestrel IUS: placement of levonorgestrel intrauterine system"
39083|NCT02362373|P1|Participant Flow|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
39084|NCT02362373|O1|Outcome|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
39085|NCT02362373|O1|Outcome|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
39086|NCT02362373|O1|Outcome|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
39087|NCT02362373|O1|Outcome|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
39088|NCT02362373|O1|Outcome|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
39089|NCT02362373|E1|Reported Event|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
39091|NCT02362360|P2|Participant Flow|Comparator Then Coloplast Test Product|"The subject first tests the Comparator and then tests the Coloplast Test Product.~Coloplast Test Product: A new 2-piece ostomy appliance developed by Coloplast A/S~Comparator (Hollister): Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag."
39092|NCT02362360|P1|Participant Flow|Coloplast Test Product Then Comparator|"The subject first tests the Coloplast Test Product and then tests the Comparator~Coloplast Test Product: A new 2-piece ostomy appliance developed by Coloplast A/S~Comparator (Hollister): Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag."
39093|NCT02362360|O2|Outcome|Comparator|Answers from subjects testing Comparator
39094|NCT02362360|O1|Outcome|Coloplast Test Product|Answers from subjects testing Coloplast test product
39095|NCT02362360|E2|Reported Event|Comparator|Answers from subjects testing Comparator
39096|NCT02362360|E1|Reported Event|Coloplast Test Product|Answers from subjects testing Coloplast test product
39097|NCT02362321|B3|Baseline|Total|Total of all reporting groups
39098|NCT02362321|B2|Baseline|Control|Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
39099|NCT02362321|B1|Baseline|Dexamethasone|"Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).~Dexamethasone: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs)."
39100|NCT02362321|P2|Participant Flow|Control|Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
39101|NCT02362321|P1|Participant Flow|Dexamethasone|"Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).~Dexamethasone: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs)."
39102|NCT02362321|O2|Outcome|Control|Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
39103|NCT02362321|O1|Outcome|Dexamethasone|"Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).~Dexamethasone: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs)."
39104|NCT02362321|E2|Reported Event|Control|Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
39105|NCT02362321|E1|Reported Event|Dexamethasone|"Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).~Dexamethasone: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs)."
39106|NCT02361736|B3|Baseline|Total|Total of all reporting groups
39107|NCT02361736|B2|Baseline|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
39108|NCT02361736|B1|Baseline|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
39109|NCT02361736|P2|Participant Flow|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
39110|NCT02361736|P1|Participant Flow|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
39111|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
39112|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
39113|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
39114|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
39115|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
39116|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
39377|NCT02359877|O2|Outcome|BCD-054 - 60 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, intramuscular injection
39117|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
39118|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
39119|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
39120|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
39121|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
39122|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
39123|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
39124|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
39125|NCT02361736|E2|Reported Event|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
39126|NCT02361736|E1|Reported Event|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
39127|NCT02361580|B3|Baseline|Total|Total of all reporting groups
39128|NCT02361580|B2|Baseline|No Diary|Control Group
39129|NCT02361580|B1|Baseline|Diary|"Subjects that are randomized to the diary group will be told to keep a diary of their recovery. The study is focusing on the effect of keeping a diary on disability, rather than the content of the diary.~Diary: Subject keeps diary of recovery"
39130|NCT02361580|P2|Participant Flow|No Diary|Control Group
39131|NCT02361580|P1|Participant Flow|Diary|"Subjects that are randomized to the diary group will be told to keep a diary of their recovery. The study is focusing on the effect of keeping a diary on disability, rather than the content of the diary.~Diary: Subject keeps diary of recovery"
39132|NCT02361580|O2|Outcome|No Diary|Control Group
39133|NCT02361580|O1|Outcome|Diary|"Subjects that are randomized to the diary group will be told to keep a diary of their recovery. The study is focusing on the effect of keeping a diary on disability, rather than the content of the diary.~Diary: Subject keeps diary of recovery"
39134|NCT02361580|O2|Outcome|No Diary|Control Group
39135|NCT02361580|O1|Outcome|Diary|"Subjects that are randomized to the diary group will be told to keep a diary of their recovery. The study is focusing on the effect of keeping a diary on disability, rather than the content of the diary.~Diary: Subject keeps diary of recovery"
39136|NCT02361580|O2|Outcome|No Diary|Control Group
39137|NCT02361580|O1|Outcome|Diary|"Subjects that are randomized to the diary group will be told to keep a diary of their recovery. The study is focusing on the effect of keeping a diary on disability, rather than the content of the diary.~Diary: Subject keeps diary of recovery"
39138|NCT02361580|E2|Reported Event|No Diary|Control Group
39139|NCT02361580|E1|Reported Event|Diary|"Subjects that are randomized to the diary group will be told to keep a diary of their recovery. The study is focusing on the effect of keeping a diary on disability, rather than the content of the diary.~Diary: Subject keeps diary of recovery"
39140|NCT02360995|B4|Baseline|Total|Total of all reporting groups
39141|NCT02360995|B3|Baseline|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
39142|NCT02360995|B2|Baseline|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
39143|NCT02360995|B1|Baseline|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
39144|NCT02360995|P3|Participant Flow|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
39145|NCT02360995|P2|Participant Flow|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
39146|NCT02360995|P1|Participant Flow|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
39147|NCT02360995|O3|Outcome|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
39148|NCT02360995|O2|Outcome|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
39149|NCT02360995|O1|Outcome|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
39150|NCT02360995|O3|Outcome|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
39151|NCT02360995|O2|Outcome|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
39152|NCT02360995|O1|Outcome|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
39153|NCT02360995|O3|Outcome|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
39154|NCT02360995|O2|Outcome|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
39155|NCT02360995|O1|Outcome|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
39156|NCT02360995|O3|Outcome|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
39157|NCT02360995|O2|Outcome|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
39158|NCT02360995|O1|Outcome|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
39159|NCT02360995|O3|Outcome|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
39160|NCT02360995|O2|Outcome|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
39161|NCT02360995|O1|Outcome|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
39162|NCT02360995|O3|Outcome|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
39163|NCT02360995|O2|Outcome|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
39164|NCT02360995|O1|Outcome|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
39165|NCT02360995|E3|Reported Event|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
39237|NCT02360228|P3|Participant Flow|Sham Stimulation|Will include 10 seconds of ramp in to 1 minutes of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily.
39166|NCT02360995|E2|Reported Event|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
39167|NCT02360995|E1|Reported Event|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
39168|NCT02360475|B5|Baseline|Total|Total of all reporting groups
39169|NCT02360475|B4|Baseline|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39170|NCT02360475|B3|Baseline|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39171|NCT02360475|B2|Baseline|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39172|NCT02360475|B1|Baseline|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39173|NCT02360475|P4|Participant Flow|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39174|NCT02360475|P3|Participant Flow|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39175|NCT02360475|P2|Participant Flow|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39176|NCT02360475|P1|Participant Flow|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39177|NCT02360475|O4|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39178|NCT02360475|O3|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39179|NCT02360475|O2|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39180|NCT02360475|O1|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39181|NCT02360475|O4|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39182|NCT02360475|O3|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39183|NCT02360475|O2|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39184|NCT02360475|O1|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39185|NCT02360475|O4|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39186|NCT02360475|O3|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39187|NCT02360475|O2|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39188|NCT02360475|O1|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39238|NCT02360228|P2|Participant Flow|tDCS|2mA transcranial direct current stimulation (tDCS) for 20 minutes twice daily
39189|NCT02360475|O4|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39190|NCT02360475|O3|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39191|NCT02360475|O2|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39192|NCT02360475|O1|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39193|NCT02360475|O4|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39194|NCT02360475|O3|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39195|NCT02360475|O2|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39196|NCT02360475|O1|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39197|NCT02360475|O4|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39198|NCT02360475|O3|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39199|NCT02360475|O2|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39200|NCT02360475|O1|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39201|NCT02360475|O4|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39202|NCT02360475|O3|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39203|NCT02360475|O2|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39204|NCT02360475|O1|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39205|NCT02360475|O4|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39206|NCT02360475|O3|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39207|NCT02360475|O2|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39208|NCT02360475|O1|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39209|NCT02360475|O4|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39210|NCT02360475|O3|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39211|NCT02360475|O2|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39212|NCT02360475|O1|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39213|NCT02360475|O4|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39214|NCT02360475|O3|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39215|NCT02360475|O2|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39216|NCT02360475|O1|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39217|NCT02360475|O4|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39218|NCT02360475|O3|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39219|NCT02360475|O2|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39220|NCT02360475|O1|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39221|NCT02360475|O4|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39222|NCT02360475|O3|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39223|NCT02360475|O2|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39224|NCT02360475|O1|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39225|NCT02360475|O4|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39226|NCT02360475|O3|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39227|NCT02360475|O2|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39228|NCT02360475|O1|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39229|NCT02360475|E4|Reported Event|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39230|NCT02360475|E3|Reported Event|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39231|NCT02360475|E2|Reported Event|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39232|NCT02360475|E1|Reported Event|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
39233|NCT02360228|B4|Baseline|Total|Total of all reporting groups
39234|NCT02360228|B3|Baseline|Sham Stimulation|"Will include 10 seconds of ramp in to 1 minutes of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily.~tACS (alpha)"
39235|NCT02360228|B2|Baseline|tDCS|"2mA stimulation for 20 minutes twice daily~tDCS"
39236|NCT02360228|B1|Baseline|tACS (Alpha)|"10Hz tACS with a peak-to-peak amplitude of 2mA for 20 minutes twice daily~tACS (alpha)"
39239|NCT02360228|P1|Participant Flow|tACS (Alpha)|"10Hz transcranial alternating current stimulation (tACS) at the alpha frequency with a peak-to-peak amplitude of 2mA for 20 minutes twice daily~tACS (alpha)"
39240|NCT02360228|O3|Outcome|Sham Stimulation|"Will include 10 seconds of ramp in to 1 minutes of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily.~tACS (alpha)"
39241|NCT02360228|O2|Outcome|tDCS|"2mA stimulation for 20 minutes twice daily~tDCS"
39242|NCT02360228|O1|Outcome|tACS (Alpha)|"10Hz tACS with a peak-to-peak amplitude of 2mA for 20 minutes twice daily~tACS (alpha)"
39243|NCT02360228|O3|Outcome|Sham Stimulation|"Will include 10 seconds of ramp in to 1 minutes of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily.~tACS (alpha)"
39244|NCT02360228|O2|Outcome|tDCS|"2mA stimulation for 20 minutes twice daily~tDCS"
39245|NCT02360228|O1|Outcome|tACS (Alpha)|"10Hz tACS with a peak-to-peak amplitude of 2mA for 20 minutes twice daily~tACS (alpha)"
39246|NCT02360228|O3|Outcome|Sham Stimulation|"Will include 10 seconds of ramp in to 1 minutes of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily.~tACS (alpha)"
39247|NCT02360228|O2|Outcome|tDCS|"2mA stimulation for 20 minutes twice daily~tDCS"
39248|NCT02360228|O1|Outcome|tACS (Alpha)|"10Hz tACS with a peak-to-peak amplitude of 2mA for 20 minutes twice daily~tACS (alpha)"
39249|NCT02360228|O3|Outcome|Sham Stimulation|"Will include 10 seconds of ramp in to 1 minutes of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily.~tACS (alpha)"
39250|NCT02360228|O2|Outcome|tDCS|"2mA stimulation for 20 minutes twice daily~tDCS"
39251|NCT02360228|O1|Outcome|tACS (Alpha)|"10Hz tACS with a peak-to-peak amplitude of 2mA for 20 minutes twice daily~tACS (alpha)"
39252|NCT02360228|O3|Outcome|Sham Stimulation|"Will include 10 seconds of ramp in to 1 minutes of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily.~tACS (alpha)"
39253|NCT02360228|O2|Outcome|tDCS|"2mA stimulation for 20 minutes twice daily~tDCS"
39254|NCT02360228|O1|Outcome|tACS (Alpha)|"10Hz tACS with a peak-to-peak amplitude of 2mA for 20 minutes twice daily~tACS (alpha)"
39255|NCT02360228|O3|Outcome|Sham Stimulation|"Will include 10 seconds of ramp in to 1 minutes of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily.~tACS (alpha)"
39256|NCT02360228|O2|Outcome|tDCS|"2mA stimulation for 20 minutes twice daily~tDCS"
39257|NCT02360228|O1|Outcome|tACS (Alpha)|"10Hz tACS with a peak-to-peak amplitude of 2mA for 20 minutes twice daily~tACS (alpha)"
39258|NCT02360228|O3|Outcome|Sham Stimulation|"Will include 10 seconds of ramp in to 1 minutes of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily.~tACS (alpha)"
39259|NCT02360228|O2|Outcome|tDCS|"2mA stimulation for 20 minutes twice daily~tDCS"
39260|NCT02360228|O1|Outcome|tACS (Alpha)|"10Hz tACS with a peak-to-peak amplitude of 2mA for 20 minutes twice daily~tACS (alpha)"
39261|NCT02360228|E3|Reported Event|Sham Stimulation|"Will include 10 seconds of ramp in to 1 minutes of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily.~tACS (alpha)"
39262|NCT02360228|E2|Reported Event|tDCS|"2mA stimulation for 20 minutes twice daily~tDCS"
39263|NCT02360228|E1|Reported Event|tACS (Alpha)|"10Hz tACS with a peak-to-peak amplitude of 2mA for 20 minutes twice daily~tACS (alpha)"
39264|NCT02360124|B4|Baseline|Total|Total of all reporting groups
39265|NCT02360124|B3|Baseline|Silver Diammine Fluoride and KI|"the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
39266|NCT02360124|B2|Baseline|Silver Diammine Fluoride|"the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
39267|NCT02360124|B1|Baseline|Control|"instructions on oral hygiene (OHI) tailored to the individual’s condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.~Water as placebo: topical application of water as a placebo in the control arm"
39268|NCT02360124|P3|Participant Flow|Silver Diammine Fluoride and KI|"the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
39269|NCT02360124|P2|Participant Flow|Silver Diammine Fluoride|"the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
39270|NCT02360124|P1|Participant Flow|Control|"instructions on oral hygiene (OHI) tailored to the individual’s condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.~Water as placebo: topical application of water as a placebo in the control arm"
39292|NCT02359955|P2|Participant Flow|Anatomic Teeth, Then Zero-degree Teeth|edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture
39271|NCT02360124|O3|Outcome|Silver Diammine Fluoride and KI|"the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces~saturated potassium iodide solution: topical application of SDF solution followed by KI solution onto tooth root surfaces"
39272|NCT02360124|O2|Outcome|Silver Diammine Fluoride|"the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
39273|NCT02360124|O1|Outcome|Control|"instructions on oral hygiene (OHI) tailored to the individual’s condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water as placebo with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.~Water as placebo: topical application of water as a placebo in the control arm"
39274|NCT02360124|O3|Outcome|Silver Diammine Fluoride and KI|"the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
39275|NCT02360124|O2|Outcome|Silver Diammine Fluoride|"the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
39276|NCT02360124|O1|Outcome|Control|"instructions on oral hygiene (OHI) tailored to the individual’s condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.~Water as placebo: topical application of water as a placebo in the control arm"
39277|NCT02360124|E3|Reported Event|Silver Diammine Fluoride and KI|"the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
39278|NCT02360124|E2|Reported Event|Silver Diammine Fluoride|"the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
39279|NCT02360124|E1|Reported Event|Control|"instructions on oral hygiene (OHI) tailored to the individual’s condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.~Water as placebo: topical application of water as a placebo in the control arm"
39280|NCT02360059|B3|Baseline|Total|Total of all reporting groups
39281|NCT02360059|B2|Baseline|Placebo Group|Participants take placebo by mouth twice daily starting 12 days before, and 12 weeks during Paclitaxel treatment.
39282|NCT02360059|B1|Baseline|Metformin Group|Participants take 1,000 mg Metformin by mouth twice daily for 12 weeks during Paclitaxel treatment.
39283|NCT02360059|P2|Participant Flow|Placebo Group|Participants take placebo by mouth twice daily starting 12 days before, and 12 weeks during Paclitaxel treatment.
39284|NCT02360059|P1|Participant Flow|Metformin Group|Participants take 1,000 mg Metformin by mouth twice daily for 12 weeks during Paclitaxel treatment.
39285|NCT02360059|O2|Outcome|Placebo Group|Participants take placebo by mouth twice daily starting 12 days before, and 12 weeks during Paclitaxel treatment.
39286|NCT02360059|O1|Outcome|Metformin Group|Participants take 1,000 mg Metformin by mouth twice daily for 12 weeks during Paclitaxel treatment.
39287|NCT02360059|E2|Reported Event|Placebo Group|Participants take placebo by mouth twice daily starting 12 days before, and 12 weeks during Paclitaxel treatment.
39288|NCT02360059|E1|Reported Event|Metformin Group|Participants take 1,000 mg Metformin by mouth twice daily for 12 weeks during Paclitaxel treatment.
39289|NCT02359955|B3|Baseline|Total|Total of all reporting groups
39290|NCT02359955|B2|Baseline|Group 2|"edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture~zero degree teeth: zero degree teeth complete denture was first prescribed to patients in group 1 while patients in group 2 were treated with anatomic teeth complete denture~anatomic teeth: when anatomic teeth complete denture was prescribed to patients in group 1, patients in group 2 were treated with zero degree teeth complete denture"
39291|NCT02359955|B1|Baseline|Group 1|"edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture~zero degree teeth: zero degree teeth complete denture was first prescribed to patients in group 1 while patients in group 2 were treated with anatomic teeth complete denture~anatomic teeth: when anatomic teeth complete denture was prescribed to patients in group 1, patients in group 2 were treated with zero degree teeth complete denture"
66982|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
39293|NCT02359955|P1|Participant Flow|Zero-degree Teeth, Then Anatomic Teeth|edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture
39294|NCT02359955|O4|Outcome|Duration of Left Masseter of Anatomic Teeth|
39295|NCT02359955|O3|Outcome|Duration of Right Masster of Anatomic Teeth|emg parameter of patients treated with anatomic teeth complete denture
39296|NCT02359955|O2|Outcome|Duration of Left Masseter of Zero Degree Teeth|
39297|NCT02359955|O1|Outcome|Duration of Right Masseter of Zero Degree Teeth|emg parameter of patients treated with zero degree teeth
39298|NCT02359955|O4|Outcome|Amp Value of Left Masseter of Anatomic Teeth|
39299|NCT02359955|O3|Outcome|Amp Value of Right Master of Anatomic Teeth|emg parameter of patients treated with anatomic teeth complete denture
39300|NCT02359955|O2|Outcome|Amp Value of Left Masseter of Zero Degree Teeth|
39301|NCT02359955|O1|Outcome|Amp Value of Right Masseter of Zero Degree Teeth|emg parameter of edentulous patients treated with zero-degree teeth complete denture
39302|NCT02359955|O4|Outcome|Group 2 Zero Degree Teeth|
39303|NCT02359955|O3|Outcome|Group 1 Anatomic Teeth|
39304|NCT02359955|O2|Outcome|Group 2 Anatomic Teeth|edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture
39305|NCT02359955|O1|Outcome|Group 1 Zero Degree Teeth|edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture
39306|NCT02359955|E2|Reported Event|Anatomic Teeth, Then Zero-degree Teeth|edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture
39307|NCT02359955|E1|Reported Event|Zero Degree Teeth,Then Anatomic Teeth|edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture
39308|NCT02359916|B8|Baseline|Total|Total of all reporting groups
39309|NCT02359916|B7|Baseline|Baseline 2|Snacks sold under equal pricing, no delays. Baseline 2 was always the last condition at all vending sites.
39310|NCT02359916|B6|Baseline|Delay + Tax|"Less healthy snacks sold at 25% or $0.25 higher price, plus delays~Time delays on delivery of less healthy snacks~25%/$0.25 tax on less healthy snacks"
39311|NCT02359916|B5|Baseline|Tax Only|"Less healthy snacks sold at 25% or $0.25 higher price, no delays~25%/$0.25 tax on less healthy snacks"
39312|NCT02359916|B4|Baseline|Delay + Discount|"Healthy snacks sold at 25% or $0.25 discount, plus delays on less healthy snacks~25-second time delays on delivery of less healthy snacks~25%/$0.25 discount on healthy snacks"
39313|NCT02359916|B3|Baseline|Delay Only|"Less healthy snacks sold at equal pricing with delays~25-second time delays on delivery of less healthy snacks"
39314|NCT02359916|B2|Baseline|Discount Only|"Healthier snacks sold at 25% or $0.25 discount, no delays~25%/$0.25 discount on healthy snacks"
39315|NCT02359916|B1|Baseline|Baseline 1|Snacks sold under equal pricing, no delays. Baseline 1 was always the first condition at all vending sites.
39316|NCT02359916|P7|Participant Flow|Baseline 2|Snacks sold under equal pricing, no delays. Baseline 2 was always the last condition at all vending sites.
39317|NCT02359916|P6|Participant Flow|Delay + Tax|"Less healthy snacks sold at 25% or $0.25 higher price, plus delays~Time delays on delivery of less healthy snacks~25%/$0.25 tax on less healthy snacks"
39318|NCT02359916|P5|Participant Flow|Tax Only|"Less healthy snacks sold at 25% or $0.25 higher price, no delays~25%/$0.25 tax on less healthy snacks"
39319|NCT02359916|P4|Participant Flow|Delay + Discount|"Healthy snacks sold at 25% or $0.25 discount, plus delays on less healthy snacks~25-second time delays on delivery of less healthy snacks~25%/$0.25 discount on healthy snacks"
39320|NCT02359916|P3|Participant Flow|Delay Only|"Less healthy snacks sold at equal pricing with delays~25-second time delays on delivery of less healthy snacks"
39321|NCT02359916|P2|Participant Flow|Discount Only|"Healthier snacks sold at 25% or $0.25 discount, no delays~25%/$0.25 discount on healthy snacks"
39322|NCT02359916|P1|Participant Flow|Baseline 1|Snacks sold under equal pricing, no delays. Baseline 1 was always the first condition at all vending sites.
39323|NCT02359916|O6|Outcome|Delay + Tax|"Less healthy snacks sold at 25% or $0.25 higher price, plus delays~Time delays on delivery of less healthy snacks~25%/$0.25 tax on less healthy snacks"
39324|NCT02359916|O5|Outcome|Tax Only|"Less healthy snacks sold at 25% or $0.25 higher price, no delays~25%/$0.25 tax on less healthy snacks"
39325|NCT02359916|O4|Outcome|Delay + Discount|"Healthy snacks sold at 25% or $0.25 discount, plus delays on less healthy snacks~25-second time delays on delivery of less healthy snacks~25%/$0.25 discount on healthy snacks"
39326|NCT02359916|O3|Outcome|Delay Only|"Less healthy snacks sold at equal pricing with delays~25-second time delays on delivery of less healthy snacks"
39327|NCT02359916|O2|Outcome|Discount Only|"Healthier snacks sold at 25% or $0.25 discount, no delays~25%/$0.25 discount on healthy snacks"
39328|NCT02359916|O1|Outcome|Baseline|Snacks sold under equal pricing, no delays
39329|NCT02359916|O6|Outcome|Delay + Tax|"Less healthy snacks sold at 25% or $0.25 higher price, plus delays~Time delays on delivery of less healthy snacks~25%/$0.25 tax on less healthy snacks"
39330|NCT02359916|O5|Outcome|Tax Only|"Less healthy snacks sold at 25% or $0.25 higher price, no delays~25%/$0.25 tax on less healthy snacks"
39331|NCT02359916|O4|Outcome|Delay + Discount|"Healthy snacks sold at 25% or $0.25 discount, plus delays on less healthy snacks~25-second time delays on delivery of less healthy snacks~25%/$0.25 discount on healthy snacks"
39332|NCT02359916|O3|Outcome|Delay Only|"Less healthy snacks sold at equal pricing with delays~25-second time delays on delivery of less healthy snacks"
39333|NCT02359916|O2|Outcome|Discount Only|"Healthier snacks sold at 25% or $0.25 discount, no delays~25%/$0.25 discount on healthy snacks"
39334|NCT02359916|O1|Outcome|Baseline|Snacks sold under equal pricing, no delays. Data from Baseline 1 and 2 were combined in this analysis.
39335|NCT02359916|E6|Reported Event|Delay + Tax|"Less healthy snacks sold at 25% or $0.25 higher price, plus delays~Time delays on delivery of less healthy snacks~25%/$0.25 tax on less healthy snacks"
39336|NCT02359916|E5|Reported Event|Tax Only|"Less healthy snacks sold at 25% or $0.25 higher price, no delays~25%/$0.25 tax on less healthy snacks"
39376|NCT02359877|O3|Outcome|BCD-054 - 120 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, subcutaneously
39337|NCT02359916|E4|Reported Event|Delay + Discount|"Healthy snacks sold at 25% or $0.25 discount, plus delays on less healthy snacks~25-second time delays on delivery of less healthy snacks~25%/$0.25 discount on healthy snacks"
39338|NCT02359916|E3|Reported Event|Delay Only|"Less healthy snacks sold at equal pricing with delays~25-second time delays on delivery of less healthy snacks"
39339|NCT02359916|E2|Reported Event|Discount Only|"Healthier snacks sold at 25% or $0.25 discount, no delays~25%/$0.25 discount on healthy snacks"
39340|NCT02359916|E1|Reported Event|Baseline|Snacks sold under equal pricing, no delays
39341|NCT02359903|B3|Baseline|Total|Total of all reporting groups
39342|NCT02359903|B2|Baseline|Remicade Group|"Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (Remicade)"
39343|NCT02359903|B1|Baseline|BCD-055 Group|"BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha"
39344|NCT02359903|P2|Participant Flow|Remicade Group|"Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (Remicade)"
39345|NCT02359903|P1|Participant Flow|BCD-055 Group|"BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha"
39346|NCT02359903|O2|Outcome|Remicade Group|"Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (Remicade)"
39347|NCT02359903|O1|Outcome|BCD-055 Group|"BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha"
39348|NCT02359903|O2|Outcome|Remicade Group|"Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (Remicade)"
39349|NCT02359903|O1|Outcome|BCD-055 Group|"BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha"
39350|NCT02359903|E2|Reported Event|Remicade Group|"Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (Remicade)"
39351|NCT02359903|E1|Reported Event|BCD-055 Group|"BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha"
39352|NCT02359890|B1|Baseline|THERMOCOOL SMARTTOUCH® SF Family of Catheters|Pulmonary vein isolation by radiofrequency (RF) ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device)
39353|NCT02359890|P1|Participant Flow|THERMOCOOL SMARTTOUCH® SF Family of Catheters|Pulmonary vein isolation by radiofrequency (RF) ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device)
39354|NCT02359890|O1|Outcome|THERMOCOOL SMARTTOUCH® SF Catheters|Pulmonary vein isolation by radiofrequency (RF) ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device)
39355|NCT02359890|O1|Outcome|THERMOCOOL SMARTTOUCH® SF Catheters|Pulmonary vein isolation by radiofrequency (RF) ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device)
39356|NCT02359890|O1|Outcome|THERMOCOOL SMARTTOUCH® SF Catheters|Pulmonary vein isolation by radiofrequency (RF) ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device)
39357|NCT02359890|E1|Reported Event|THERMOCOOL SMARTTOUCH® SF Family of Catheters|Pulmonary vein isolation by radiofrequency (RF) ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device)
39358|NCT02359877|B5|Baseline|Total|Total of all reporting groups
39359|NCT02359877|B4|Baseline|BCD-054 (Multiple Doses)|Pegylated interferon beta 1a (BCD-054) Multiple dose - 180 mcg, IM/SC, biweekly, 3 injections
39360|NCT02359877|B3|Baseline|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
39361|NCT02359877|B2|Baseline|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
39362|NCT02359877|B1|Baseline|BCD-054 (Single Doses)|Pegylated interferon beta 1a (BCD-054) Single doses - 60 mcg, IM/SC; or 120 mcg, IM/SC; or 240 mcg, IM/SC; or 360 mcg, IM/SC
39363|NCT02359877|P4|Participant Flow|BCD-054 (Multiple Dose)|Pegylated interferon beta 1a (BCD-054) Multiple dose - 180 mcg, IM/SC, biweekly, 3 injections
39364|NCT02359877|P3|Participant Flow|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
39365|NCT02359877|P2|Participant Flow|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
39366|NCT02359877|P1|Participant Flow|BCD-054 (Single Doses)|Pegylated interferon beta 1a (BCD-054) Single doses - 60 mcg, IM/SC; or 120 mcg, IM/SC; or 240 mcg, IM/SC; or 360 mcg, IM/SC
39367|NCT02359877|O2|Outcome|BCD-054 - 180 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 180 mcg, intramuscular injection
39368|NCT02359877|O1|Outcome|BCD-054 - 180 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 180 mcg, subcutaneously
39369|NCT02359877|O10|Outcome|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
39370|NCT02359877|O9|Outcome|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
39371|NCT02359877|O8|Outcome|BCD-054 - 360 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, intramuscular injection
39372|NCT02359877|O7|Outcome|BCD-054 - 360 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, subcutaneously
39373|NCT02359877|O6|Outcome|BCD-054 - 240 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, intramuscular injection
39374|NCT02359877|O5|Outcome|BCD-054 - 240 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, subcutaneously
39375|NCT02359877|O4|Outcome|BCD-054 - 120 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, intramuscular injection
39378|NCT02359877|O1|Outcome|BCD-054 - 60 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, subcutaneously
39379|NCT02359877|O2|Outcome|BCD-054 - 180 mcg - IM|Pegylated interferon beta 1a (BCD-054)
39380|NCT02359877|O1|Outcome|BCD-054 - 180 mcg - SC|Pegylated interferon beta 1a (BCD-054)
39381|NCT02359877|O10|Outcome|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
39382|NCT02359877|O9|Outcome|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
39383|NCT02359877|O8|Outcome|BCD-054 - 360 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, intramuscular injection
39384|NCT02359877|O7|Outcome|BCD-054 - 360 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, subcutaneously
39385|NCT02359877|O6|Outcome|BCD-054 - 240 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, intramuscular injection
39386|NCT02359877|O5|Outcome|BCD-054 - 240 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, subcutaneously
39387|NCT02359877|O4|Outcome|BCD-054 - 120 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, intramuscular injection
39388|NCT02359877|O3|Outcome|BCD-054 - 120 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, subcutaneously
39389|NCT02359877|O2|Outcome|BCD-054 - 60 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, intramuscular injection
39390|NCT02359877|O1|Outcome|BCD-054 - 60 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, subcutaneously
39391|NCT02359877|O2|Outcome|BCD-054 - 180 mcg - IM|Pegylated interferon beta 1a (BCD-054)
39392|NCT02359877|O1|Outcome|BCD-054 - 180 mcg - SC|Pegylated interferon beta 1a (BCD-054)
39393|NCT02359877|O10|Outcome|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
39394|NCT02359877|O9|Outcome|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
39395|NCT02359877|O8|Outcome|BCD-054 - 360 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, intramuscular injection
39396|NCT02359877|O7|Outcome|BCD-054 - 360 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, subcutaneously
39397|NCT02359877|O6|Outcome|BCD-054 - 240 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, intramuscular injection
39398|NCT02359877|O5|Outcome|BCD-054 - 240 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, subcutaneously
39399|NCT02359877|O4|Outcome|BCD-054 - 120 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, intramuscular injection
39400|NCT02359877|O3|Outcome|BCD-054 - 120 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, subcutaneously
39401|NCT02359877|O2|Outcome|BCD-054 - 60 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, intramuscular injection
39402|NCT02359877|O1|Outcome|BCD-054 - 60 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, subcutaneously
39403|NCT02359877|E12|Reported Event|BCD-054 - 180 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 180 mcg, intramuscular injection
39404|NCT02359877|E11|Reported Event|BCD-054 - 180 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 180 mcg, subcutaneously
39405|NCT02359877|E10|Reported Event|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
39406|NCT02359877|E9|Reported Event|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
39407|NCT02359877|E8|Reported Event|BCD-054 - 360 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, intramuscular injection
39408|NCT02359877|E7|Reported Event|BCD-054 - 360 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, subcutaneously
39409|NCT02359877|E6|Reported Event|BCD-054 - 240 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, intramuscular injection
39410|NCT02359877|E5|Reported Event|BCD-054 - 240 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, subcutaneously
39411|NCT02359877|E4|Reported Event|BCD-054 - 120 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, intramuscular injection
39412|NCT02359877|E3|Reported Event|BCD-054 - 120 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, subcutaneously
39413|NCT02359877|E2|Reported Event|BCD-054 - 60 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, intramuscular injection
39414|NCT02359877|E1|Reported Event|BCD-054 - 60 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, subcutaneously
39415|NCT02359851|B1|Baseline|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity.~Pembrolizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
39416|NCT02359851|P1|Participant Flow|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity.~Pembrolizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
39417|NCT02359851|O1|Outcome|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity.~Pembrolizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
39418|NCT02359851|O1|Outcome|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity.~Pembrolizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
39419|NCT02359851|O1|Outcome|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity.~Pembrolizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
39420|NCT02359851|O1|Outcome|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity.~Pembrolizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
39421|NCT02359851|O1|Outcome|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity.~Pembrolizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
40104|NCT02357459|O3|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
39422|NCT02359851|E1|Reported Event|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity.~Pembrolizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
39423|NCT02359435|B3|Baseline|Total|Total of all reporting groups
39424|NCT02359435|B2|Baseline|Standard Triple Therapy|"pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily~Standard triple therapy: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days"
39425|NCT02359435|B1|Baseline|Reverse Hybrid Therapy|"pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily~Reverse hybrid therapy: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days"
39426|NCT02359435|P2|Participant Flow|Standard Triple Therapy|"pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily~Standard triple therapy: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days"
39427|NCT02359435|P1|Participant Flow|Reverse Hybrid Therapy|"pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily~Reverse hybrid therapy: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days"
39428|NCT02359435|O2|Outcome|Standard Triple Therapy|"pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily~Standard triple therapy: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days"
39429|NCT02359435|O1|Outcome|Reverse Hybrid Therapy|"pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily~Reverse hybrid therapy: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days"
39430|NCT02359435|E2|Reported Event|Standard Triple Therapy|"pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily~Standard triple therapy: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days"
39431|NCT02359435|E1|Reported Event|Reverse Hybrid Therapy|"pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily~Reverse hybrid therapy: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days"
39432|NCT02359305|B3|Baseline|Total|Total of all reporting groups
39433|NCT02359305|B2|Baseline|Rectal Acetaminophen|Acetaminophen administered by rectal suppository.
39434|NCT02359305|B1|Baseline|IV Acetaminophen|Acetaminophen administered by intravenous infusion.
39435|NCT02359305|P2|Participant Flow|Rectal Acetaminophen|Acetaminophen given by rectal suppository.
39436|NCT02359305|P1|Participant Flow|IV Acetaminophen|Acetaminophen given by intravenous infusion.
39437|NCT02359305|O2|Outcome|Rectal Acetaminophen|Acetaminophen administered by rectal suppository.
39438|NCT02359305|O1|Outcome|IV Acetaminophen|Acetaminophen administered by intravenous infusion.
39439|NCT02359305|O2|Outcome|Rectal Acetaminophen|Acetaminophen administered by rectal suppository.
39440|NCT02359305|O1|Outcome|IV Acetaminophen|Acetaminophen administered by intravenous infusion.
39441|NCT02359305|O2|Outcome|Rectal Acetaminophen|Acetaminophen administered by rectal suppository.
39442|NCT02359305|O1|Outcome|IV Acetaminophen|Acetaminophen administered by intravenous infusion.
39443|NCT02359305|E2|Reported Event|Rectal Acetaminophen|Acetaminophen administered by rectal suppository.
39444|NCT02359305|E1|Reported Event|IV Acetaminophen|Acetaminophen administered by intravenous infusion.
39445|NCT02359110|B3|Baseline|Total|Total of all reporting groups
39446|NCT02359110|B2|Baseline|Placebo|Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.
39447|NCT02359110|B1|Baseline|Gabapentin|Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.
39448|NCT02359110|P2|Participant Flow|Placebo|Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.
39449|NCT02359110|P1|Participant Flow|Gabapentin|Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.
39450|NCT02359110|O2|Outcome|Placebo|Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.
39451|NCT02359110|O1|Outcome|Gabapentin|Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.
39452|NCT02359110|O2|Outcome|Placebo|Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.
39453|NCT02359110|O1|Outcome|Gabapentin|Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.
39454|NCT02359110|O2|Outcome|Placebo|Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.
39455|NCT02359110|O1|Outcome|Gabapentin|Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.
39456|NCT02359110|E2|Reported Event|Placebo|Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.
39457|NCT02359110|E1|Reported Event|Gabapentin|Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.
39458|NCT02359058|B4|Baseline|Total|Total of all reporting groups
39459|NCT02359058|B3|Baseline|Ramucirumab + S-1 + Oxaliplatin|Ramucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
39510|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
40105|NCT02357459|O2|Outcome|Placebo|Normal Saline: Single 5 mL IA injection
39460|NCT02359058|B2|Baseline|Ramucirumab + S-1 + Cisplatin|Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
39461|NCT02359058|B1|Baseline|Ramucirumab + Capecitabine + Cisplatin|Ramucirumab 8 mg/kg given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
39462|NCT02359058|P3|Participant Flow|Ramucirumab + S-1 + Oxaliplatin|Ramucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
39463|NCT02359058|P2|Participant Flow|Ramucirumab + S-1 + Cisplatin|Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
39464|NCT02359058|P1|Participant Flow|Ramucirumab + Capecitabine + Cisplatin|Ramucirumab 8 mg/kg given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
39465|NCT02359058|O3|Outcome|Ramucirumab + S-1 + Oxaliplatin|Ramucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
39466|NCT02359058|O2|Outcome|Ramucirumab + S-1 + Cisplatin|Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
39467|NCT02359058|O1|Outcome|Ramucirumab + Capecitabine + Cisplatin|Ramucirumab 8 mg/kg given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
39468|NCT02359058|O4|Outcome|Total|Ramucirumab + Capecitabine + Cisplatin, Ramucirumab + S-1 + Cisplatin and Ramucirumab + S-1 + Oxaliplatin.
39469|NCT02359058|O3|Outcome|Ramucirumab + S-1 + Oxaliplatin|Ramucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
39470|NCT02359058|O2|Outcome|Ramucirumab + S-1 + Cisplatin|Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
39471|NCT02359058|O1|Outcome|Ramucirumab + Capecitabine + Cisplatin|Ramucirumab 8 mg/kg given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
39472|NCT02359058|O3|Outcome|Ramucirumab + S-1 + Oxaliplatin|Ramucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
39473|NCT02359058|O2|Outcome|Ramucirumab + S-1 + Cisplatin|Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
39474|NCT02359058|O1|Outcome|Ramucirumab + Capecitabine + Cisplatin|Ramucirumab 8 mg/kg given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
39475|NCT02359058|O3|Outcome|Ramucirumab + S-1 + Oxaliplatin|Ramucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
39476|NCT02359058|O2|Outcome|Ramucirumab + S-1 + Cisplatin|Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
39477|NCT02359058|O1|Outcome|Ramucirumab + Capecitabine + Cisplatin|Ramucirumab 8 mg/kg given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
39478|NCT02359058|O3|Outcome|Ramucirumab + S-1 + Oxaliplatin|Ramucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
39479|NCT02359058|O2|Outcome|Ramucirumab + S-1 + Cisplatin|Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
39922|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
39480|NCT02359058|O1|Outcome|Ramucirumab + Capecitabine + Cisplatin|Ramucirumab 8 mg/kg given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
39481|NCT02359058|E3|Reported Event|Ramucirumab + S-1 + Oxaliplatin|Ramucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
39482|NCT02359058|E2|Reported Event|Ramucirumab + S-1 + Cisplatin|Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
39483|NCT02359058|E1|Reported Event|Ramucirumab + Capecitabine + Cisplatin|Ramucirumab 8 mg/kg given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
39484|NCT02359045|B3|Baseline|Total|Total of all reporting groups
39485|NCT02359045|B2|Baseline|Part 2|"Subjects received a single dose of 3 treatments for 3 periods to assess the relative bioavailability and to characterize and compare the PK profiles of the two different prototype capsule formulations (Treatment A, B) in relation to Epanova capsules (Treatment C), under fed conditions.~A-D1400147, B- D14000136 or D14000137 & C- Epanova."
39486|NCT02359045|B1|Baseline|Part 1|"Subjects received a single dose of 4 treatments for 4 periods to assess the relative bioavailability and to characterize and compare the PK profiles of the three different prototype capsule formulations (Treatment A, B, C) in relation to Epanova capsules (Treatment D), under fasted conditions.~A- D1400147, B- D14000136, C- D14000137 & D- Epanova."
39487|NCT02359045|P2|Participant Flow|Part 2|"Subjects received a single dose of 3 treatments for 3 periods to assess the relative bioavailability and to characterize and compare the PK profiles of the two different prototype capsule formulations (Treatment A, B) in relation to Epanova capsules (Treatment C), under fed conditions.~A-D1400147, B- D14000136 or D14000137 & C- Epanova."
39488|NCT02359045|P1|Participant Flow|Part 1|"Subjects received a single dose of 4 treatments for 4 periods to assess the relative bioavailability and to characterize and compare the PK profiles of the three different prototype capsule formulations (Treatment A, B, C) in relation to Epanova capsules (Treatment D), under fasted conditions.~A- D1400147, B- D14000136, C- D14000137 & D- Epanova."
39489|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39490|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39491|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39492|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39493|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39494|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39495|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39496|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39497|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39498|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39499|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39500|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39501|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39502|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39503|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39504|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39505|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39506|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39507|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39508|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39509|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39923|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
39511|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39512|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39513|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39514|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39515|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39516|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39517|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39518|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39519|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39520|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39521|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39522|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39523|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39524|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39525|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39526|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39527|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39528|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39529|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39530|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39531|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39532|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39533|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39534|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39535|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39536|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39537|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39538|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39539|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39540|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39541|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39542|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39543|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39544|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39545|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39546|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39547|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39548|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39549|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39550|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39551|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39552|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39553|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39554|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39555|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39556|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39557|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39558|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39559|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39560|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39561|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39562|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39563|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39564|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39565|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39566|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39567|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39568|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39569|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39570|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39571|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39572|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39573|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39574|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39575|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39576|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39577|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39578|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39579|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39580|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39581|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39582|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39583|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39584|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39924|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
39585|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39586|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39587|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39588|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39589|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39590|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39591|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39592|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39593|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39594|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39595|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39596|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39597|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39598|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39599|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39600|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39601|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39602|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39603|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39604|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39605|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39606|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39607|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39608|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39609|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39610|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39611|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39612|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39613|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39614|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39615|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39616|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39617|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39618|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39619|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39620|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39621|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39925|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
39622|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39623|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39624|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39625|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39626|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39627|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39628|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39629|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39630|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39631|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39632|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39633|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39634|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39635|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39636|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39637|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39638|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39639|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39640|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39641|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39642|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39643|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39644|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39645|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39646|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39647|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39648|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39649|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39650|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39651|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39652|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39653|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39654|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39655|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39656|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39657|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39658|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39926|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
39659|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39660|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39661|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39662|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39663|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39664|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39665|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39666|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39667|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39668|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39669|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39670|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39671|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39672|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39673|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39674|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39675|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39676|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39677|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39678|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39679|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39680|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39681|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39682|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39683|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39684|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39685|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39686|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39687|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39688|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39689|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39690|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39691|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39692|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39693|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39694|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39695|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39927|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
39696|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39697|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39698|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39699|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39700|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39701|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39702|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39703|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39704|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39705|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39706|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39707|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39708|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39709|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39710|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39711|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39712|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39713|NCT02359045|E7|Reported Event|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
39714|NCT02359045|E6|Reported Event|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
39715|NCT02359045|E5|Reported Event|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
39716|NCT02359045|E4|Reported Event|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
39717|NCT02359045|E3|Reported Event|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
39718|NCT02359045|E2|Reported Event|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
39719|NCT02359045|E1|Reported Event|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
39720|NCT02358876|B1|Baseline|Participants|
39721|NCT02358876|P1|Participant Flow|Participants|
39722|NCT02358876|O1|Outcome|Participants|
39723|NCT02358876|E1|Reported Event|Participants|
39724|NCT02358668|B4|Baseline|Total|Total of all reporting groups
39725|NCT02358668|B3|Baseline|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39726|NCT02358668|B2|Baseline|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39727|NCT02358668|B1|Baseline|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39728|NCT02358668|P3|Participant Flow|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39729|NCT02358668|P2|Participant Flow|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39730|NCT02358668|P1|Participant Flow|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39731|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39732|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39928|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
39929|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
39733|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39734|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39735|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39736|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39737|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39738|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39739|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39740|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39741|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39742|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39743|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39744|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39745|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39746|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39747|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39748|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39749|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39750|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39751|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39752|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39753|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39754|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39755|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39756|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39757|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39758|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39759|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39930|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
39931|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
39760|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39761|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39762|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39763|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39764|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39765|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39766|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39767|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39768|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39769|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39770|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39771|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39772|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39773|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39774|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39775|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39776|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39777|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39778|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39779|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39780|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39781|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39782|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39783|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39784|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39785|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39786|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39932|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
39933|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
39787|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39788|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39789|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39790|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39791|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39792|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39793|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39794|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39795|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39796|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39797|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39798|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39799|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39800|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39801|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39802|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39803|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39804|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39805|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39806|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39807|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39808|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39809|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39810|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39811|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39812|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39813|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39934|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
39935|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
39814|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39815|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39816|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39817|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39818|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39819|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39820|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39821|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39822|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39823|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39824|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39825|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39826|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39827|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39828|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39829|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39830|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39831|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39832|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39833|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39834|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39835|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39836|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39837|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39838|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39839|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39840|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39936|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
39937|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
39841|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39842|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39843|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39844|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39845|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39846|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39847|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39848|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39849|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39850|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39851|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39852|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39853|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39854|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39855|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39856|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39857|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39858|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39859|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39860|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39861|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39862|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39863|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39864|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39865|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39866|NCT02358668|E3|Reported Event|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
39867|NCT02358668|E2|Reported Event|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39938|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
39939|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
39868|NCT02358668|E1|Reported Event|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
39869|NCT02358044|B3|Baseline|Total|Total of all reporting groups
39870|NCT02358044|B2|Baseline|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
39871|NCT02358044|B1|Baseline|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
39872|NCT02358044|P2|Participant Flow|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
39873|NCT02358044|P1|Participant Flow|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
39874|NCT02358044|O2|Outcome|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
39875|NCT02358044|O1|Outcome|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
39876|NCT02358044|O2|Outcome|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
39877|NCT02358044|O1|Outcome|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
39878|NCT02358044|O2|Outcome|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
39879|NCT02358044|O1|Outcome|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
39880|NCT02358044|O2|Outcome|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
39881|NCT02358044|O1|Outcome|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
39882|NCT02358044|O2|Outcome|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
39883|NCT02358044|O1|Outcome|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
39884|NCT02358044|O2|Outcome|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
39885|NCT02358044|O1|Outcome|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
39886|NCT02358044|E2|Reported Event|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
39887|NCT02358044|E1|Reported Event|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
39888|NCT02357940|B3|Baseline|Total|Total of all reporting groups
39889|NCT02357940|B2|Baseline|Babies|Babies - 1% Colloidal Oatmeal Balm
39890|NCT02357940|B1|Baseline|Adults|Adults - 1% Colloidal Oatmeal Balm
39891|NCT02357940|P2|Participant Flow|Babies|Babies - 1% Colloidal Oatmeal Balm
39892|NCT02357940|P1|Participant Flow|Adults|Adults - 1% Colloidal Oatmeal Balm
39893|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
39894|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
39895|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
39896|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
39897|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
39898|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
39899|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
39900|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
39901|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
39902|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
39903|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
39904|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
39905|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
39906|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
39907|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
39908|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
39909|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
39910|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
39911|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
39912|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
39913|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
39914|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
39915|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
39916|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
39917|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
39918|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
39919|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
39920|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
39921|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
40016|NCT02357901|B3|Baseline|Combined Placebo|"Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40017|NCT02357901|B2|Baseline|RBP-6000 300mg/300mg|"Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40018|NCT02357901|B1|Baseline|RBP-6000 300mg/100mg|"Participants were given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 were separated by 28 days (Day 57-Day 141) and contained RBP-6000 100 mg.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40019|NCT02357901|P4|Participant Flow|Combined Placebo|"Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40020|NCT02357901|P3|Participant Flow|RBP-6000 300mg/300mg|"Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40021|NCT02357901|P2|Participant Flow|RBP-6000 300mg/100mg|"Participants were given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 were separated by 28 days (Day 57-Day 141) and contained RBP-6000 100 mg.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40022|NCT02357901|P1|Participant Flow|Run-In Period|During the Run-In Period, participants were inducted onto SUBOXONE sublingual film followed by a 4- to 11-day SUBOXONE sublingual film open-label run-in dose-adjustment period to achieve buprenorphine dosages ranging from 8 to 24 mg according to the SUBOXONE sublingual film prescribing information.
40023|NCT02357901|O3|Outcome|Combined Placebo|"Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40024|NCT02357901|O2|Outcome|RBP-6000 300mg/300mg|"Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40025|NCT02357901|O1|Outcome|RBP-6000 300mg/100mg|"Participants were given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 were separated by 28 days (Day 57-Day 141) and contained RBP-6000 100 mg.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40026|NCT02357901|O3|Outcome|Combined Placebo|"Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40027|NCT02357901|O2|Outcome|RBP-6000 300mg/300mg|"Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40028|NCT02357901|O1|Outcome|RBP-6000 300mg/100mg|"Participants were given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 were separated by 28 days (Day 57-Day 141) and contained RBP-6000 100 mg.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40029|NCT02357901|O3|Outcome|Combined Placebo|"Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40030|NCT02357901|O2|Outcome|RBP-6000 300mg/300mg|"Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40031|NCT02357901|O1|Outcome|RBP-6000 300mg/100mg|"Participants were given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 were separated by 28 days (Day 57-Day 141) and contained RBP-6000 100 mg.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40032|NCT02357901|O3|Outcome|Combined Placebo|"Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40033|NCT02357901|O2|Outcome|RBP-6000 300mg/300mg|"Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40034|NCT02357901|O1|Outcome|RBP-6000 300mg/100mg|"Participants were given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 were separated by 28 days (Day 57-Day 141) and contained RBP-6000 100 mg.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40035|NCT02357901|O3|Outcome|Combined Placebo|"Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40036|NCT02357901|O2|Outcome|RBP-6000 300mg/300mg|"Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40037|NCT02357901|O1|Outcome|RBP-6000 300mg/100mg|"Participants were given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 were separated by 28 days (Day 57-Day 141) and contained RBP-6000 100 mg.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40038|NCT02357901|O3|Outcome|Combined Placebo|"Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40039|NCT02357901|O2|Outcome|RBP-6000 300mg/300mg|"Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40040|NCT02357901|O1|Outcome|RBP-6000 300mg/100mg|"Participants were given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 were separated by 28 days (Day 57-Day 141) and contained RBP-6000 100 mg.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40041|NCT02357901|O3|Outcome|Combined Placebo|"Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40042|NCT02357901|O2|Outcome|RBP-6000 300mg/300mg|"Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40043|NCT02357901|O1|Outcome|RBP-6000 300mg/100mg|"Participants were given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 were separated by 28 days (Day 57-Day 141) and contained RBP-6000 100 mg.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40044|NCT02357901|O3|Outcome|Combined Placebo|"Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40045|NCT02357901|O2|Outcome|RBP-6000 300mg/300mg|"Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40046|NCT02357901|O1|Outcome|RBP-6000 300mg/100mg|"Participants were given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 were separated by 28 days (Day 57-Day 141) and contained RBP-6000 100 mg.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40106|NCT02357459|O1|Outcome|FX006 32 mg|FX006: Single 5 mL IA injection
40107|NCT02357459|O3|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
40108|NCT02357459|O2|Outcome|Placebo|Normal Saline: Single 5 mL IA injection
40109|NCT02357459|O1|Outcome|FX006 32 mg|FX006: Single 5 mL IA injection
40047|NCT02357901|O3|Outcome|Combined Placebo|"Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40048|NCT02357901|O2|Outcome|RBP-6000 300mg/300mg|"Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40049|NCT02357901|O1|Outcome|RBP-6000 300mg/100mg|"Participants were given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 were separated by 28 days (Day 57-Day 141) and contained RBP-6000 100 mg.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40050|NCT02357901|O3|Outcome|Combined Placebo|"Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40051|NCT02357901|O2|Outcome|RBP-6000 300mg/300mg|"Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40052|NCT02357901|O1|Outcome|RBP-6000 300mg/100mg|"Participants were given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 were separated by 28 days (Day 57-Day 141) and contained RBP-6000 100 mg.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40053|NCT02357901|O3|Outcome|Combined Placebo|"Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40054|NCT02357901|O2|Outcome|RBP-6000 300mg/300mg|"Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40055|NCT02357901|O1|Outcome|RBP-6000 300mg/100mg|"Participants were given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 were separated by 28 days (Day 57-Day 141) and contained RBP-6000 100 mg.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40056|NCT02357901|O3|Outcome|Combined Placebo|"Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40057|NCT02357901|O2|Outcome|RBP-6000 300mg/300mg|"Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40058|NCT02357901|O1|Outcome|RBP-6000 300mg/100mg|"Participants were given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 were separated by 28 days (Day 57-Day 141) and contained RBP-6000 100 mg.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40059|NCT02357901|O3|Outcome|Combined Placebo|"Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40060|NCT02357901|O2|Outcome|RBP-6000 300mg/300mg|"Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40061|NCT02357901|O1|Outcome|RBP-6000 300mg/100mg|"Participants were given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 were separated by 28 days (Day 57-Day 141) and contained RBP-6000 100 mg.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40110|NCT02357459|O3|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
40111|NCT02357459|O2|Outcome|Placebo|Normal Saline: Single 5 mL IA injection
40112|NCT02357459|O1|Outcome|FX006 32 mg|FX006: Single 5 mL IA injection
40113|NCT02357459|O2|Outcome|Placebo|Normal Saline: Single 5 mL IA injection.
40062|NCT02357901|O3|Outcome|Combined Placebo|"Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40063|NCT02357901|O2|Outcome|RBP-6000 300mg/300mg|"Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40064|NCT02357901|O1|Outcome|RBP-6000 300mg/100mg|"Participants were given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 were separated by 28 days (Day 57-Day 141) and contained RBP-6000 100 mg.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40065|NCT02357901|O3|Outcome|Combined Placebo|"Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40066|NCT02357901|O2|Outcome|RBP-6000 300mg/300mg|"Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40067|NCT02357901|O1|Outcome|RBP-6000 300mg/100mg|"Participants were given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 were separated by 28 days (Day 57-Day 141) and contained RBP-6000 100 mg.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40068|NCT02357901|E3|Reported Event|Combined Placebo|"Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40069|NCT02357901|E2|Reported Event|RBP-6000 300mg/300mg|"Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40070|NCT02357901|E1|Reported Event|RBP-6000 300mg/100mg|"Participants were given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 were separated by 28 days (Day 57-Day 141) and contained RBP-6000 100 mg.~As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.~In addition, participants received individual drug counseling (IDC) at least once a week."
40071|NCT02357485|B1|Baseline|Treatment Arm|Single injection of ADSC
40072|NCT02357485|P1|Participant Flow|Treatment Arm|Single injection of Adipose-derived Stromal Cells (ADSC) into intra-articular space of the knee
40073|NCT02357485|O1|Outcome|Treatment Arm|Single injection of ADSC
40074|NCT02357485|O1|Outcome|Treatment Arm|Single injection of ADSC
40075|NCT02357485|O1|Outcome|Treatment Arm|"Single injection of ADSC~ADSC: Single injection of ADSC"
40076|NCT02357485|O1|Outcome|Treatment Arm|Single injection of ADSC
40077|NCT02357485|O1|Outcome|Treatment Arm|Single injection of ADSC
40078|NCT02357485|E1|Reported Event|Treatment Arm|Single injection of ADSC
40079|NCT02357459|B4|Baseline|Total|Total of all reporting groups
40080|NCT02357459|B3|Baseline|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
40081|NCT02357459|B2|Baseline|Placebo|Normal Saline: Single 5 mL IA injection
40082|NCT02357459|B1|Baseline|FX006 32mg|FX006: Single 5 mL IA injection
40083|NCT02357459|P3|Participant Flow|TCA IR 40 mg|161 subjects received TCA IR 40 mg as a single 1 mL IA injection
40084|NCT02357459|P2|Participant Flow|Placebo|162 subjects received normal saline as a single 5 mL IA injection.
40085|NCT02357459|P1|Participant Flow|FX006 32mg|161 subjects received FX006 32 mg as a single 5 mL IA injection
40086|NCT02357459|O3|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
40087|NCT02357459|O2|Outcome|Placebo|Normal Saline: Single 5 mL IA injection
40088|NCT02357459|O1|Outcome|FX006 32 mg|FX006: Single 5 mL IA injection
40089|NCT02357459|O3|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
40090|NCT02357459|O2|Outcome|Placebo|Normal Saline: Single 5 mL IA injection
40091|NCT02357459|O1|Outcome|FX006 32 mg|FX006: Single 5 mL IA injection
40092|NCT02357459|O3|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
40093|NCT02357459|O2|Outcome|Placebo|Normal Saline: Single 5 mL IA injection
40094|NCT02357459|O1|Outcome|FX006 32 mg|FX006: Single 5 mL IA injection
40095|NCT02357459|O3|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
40096|NCT02357459|O2|Outcome|Placebo|Normal Saline: Single 5 mL IA injection
40097|NCT02357459|O1|Outcome|FX006 32 mg|FX006: Single 5 mL IA injection
40098|NCT02357459|O3|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
40099|NCT02357459|O2|Outcome|Placebo|Normal Saline: Single 5 mL IA injection
40100|NCT02357459|O1|Outcome|FX006 32 mg|FX006: Single 5 mL IA injection
40101|NCT02357459|O3|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
40115|NCT02357459|O2|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
40116|NCT02357459|O1|Outcome|FX006 32 mg|FX006: Single 5 mL IA injection
40117|NCT02357459|O2|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
40118|NCT02357459|O1|Outcome|FX006 32 mg|FX006: Single 5 mL IA injection
40119|NCT02357459|O2|Outcome|Placebo|Normal Saline: Single 5 mL IA injection.
40120|NCT02357459|O1|Outcome|FX006 32mg|FX006: Single 5 mL IA injection
40121|NCT02357459|O2|Outcome|Placebo|Normal Saline: Single 5 mL IA injection.
40122|NCT02357459|O1|Outcome|FX006 32mg|FX006: Single 5 mL IA injection
40123|NCT02357459|E3|Reported Event|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
40124|NCT02357459|E2|Reported Event|Placebo|Normal Saline: Single 5 mL IA injection
40125|NCT02357459|E1|Reported Event|FX006 32mg|FX006: Single 5 mL IA injection
40126|NCT02357342|B3|Baseline|Total|Total of all reporting groups
40127|NCT02357342|B2|Baseline|Standard of Care Intravitreal antiVEGF|"antiVEGF intravitreal injections~Standard of Care intravitreal injections of antiVEGF: intravitreal injections of antiVEGF"
40128|NCT02357342|B1|Baseline|Sirolimus|"Intravitreal Sirolimus~Sirolimus: intravitreal injection"
40129|NCT02357342|P2|Participant Flow|Standard of Care Intravitreal Anti-VEGF|Standard of Care intravitreal injections of either bevacizumab (1.25mg/0.05ml) or aflibercept (2mg/0.05ml). Bevacizumab injections were repeated at monthly intervals and aflibercept was given at baseline, month 2 and 4 and sham injections at months 1, 3 and 5. Subjects in this group continued the same drug they were on prior to joining the study.
40130|NCT02357342|P1|Participant Flow|Sirolimus|"Intravitreal Sirolimus~Sirolimus: intravitreal injection at baseline, month 2 and month 4. Sham injections at months 1, 3 and 5"
40131|NCT02357342|O2|Outcome|Standard of Care Intravitreal Anti-VEGF|Standard of Care intravitreal injections of either bevacizumab (1.25mg/0.05ml) or aflibercept (2mg/0.05ml). Bevacizumab injections were repeated at monthly intervals and aflibercept was given at baseline, month 2 and 4 and sham injections at months 1, 3 and 5. Subjects in this group continued the same drug they were on prior to joining the study.
40132|NCT02357342|O1|Outcome|Sirolimus|"Intravitreal Sirolimus~Sirolimus: intravitreal injection at baseline, month 2 and month 4. Sham injections at months 1, 3 and 5"
40133|NCT02357342|O2|Outcome|Standard of Care Intravitreal Anti-VEGF|Standard of Care intravitreal injections of either bevacizumab (1.25mg/0.05ml) or aflibercept (2mg/0.05ml). Bevacizumab injections were repeated at monthly intervals and aflibercept was given at baseline, month 2 and 4 and sham injections at months 1, 3 and 5. Subjects in this group continued the same drug they were on prior to joining the study.
40134|NCT02357342|O1|Outcome|Sirolimus|"Intravitreal Sirolimus~Sirolimus: intravitreal injection at baseline, month 2 and month 4. Sham injections at months 1, 3 and 5"
40135|NCT02357342|O2|Outcome|Standard of Care Intravitreal Anti-VEGF|Standard of Care intravitreal injections of either bevacizumab (1.25mg/0.05ml) or aflibercept (2mg/0.05ml). Bevacizumab injections were repeated at monthly intervals and aflibercept was given at baseline, month 2 and 4 and sham injections at months 1, 3 and 5. Subjects in this group continued the same drug they were on prior to joining the study.
40136|NCT02357342|O1|Outcome|Sirolimus|"Intravitreal Sirolimus~Sirolimus: intravitreal injection at baseline, month 2 and month 4. Sham injections at months 1, 3 and 5"
40137|NCT02357342|E2|Reported Event|Standard of Care Intravitreal Anti-VEGF|Standard of Care intravitreal injections of either bevacizumab (1.25mg/0.05ml) or aflibercept (2mg/0.05ml). Bevacizumab injections were repeated at monthly intervals and aflibercept was given at baseline, month 2 and 4 and sham injections at months 1, 3 and 5. Subjects in this group continued the same drug they were on prior to joining the study.
40138|NCT02357342|E1|Reported Event|Sirolimus|"Intravitreal Sirolimus~Sirolimus: intravitreal injection at baseline, month 2 and month 4. Sham injections at months 1, 3 and 5"
40139|NCT02357264|B3|Baseline|Total|Total of all reporting groups
40140|NCT02357264|B2|Baseline|No Pre-eclampsia.|"Ultrasound of Pregnant Females 18+ with no pre-eclampsia~Ultrasound: Ultrasound of the chest for the detection of fluid in the lung"
40141|NCT02357264|B1|Baseline|Pre-eclampsia|"Ultrasound of Pregnant Females 18+ with pre-Eclampsia~Ultrasound: Ultrasound of the chest for the detection of fluid in the lung"
40142|NCT02357264|P2|Participant Flow|No Pre-eclampsia.|"Ultrasound of Pregnant Females 18+ with no pre-eclampsia~Ultrasound: Ultrasound of the chest for the detection of fluid in the lung"
40143|NCT02357264|P1|Participant Flow|Pre-eclampsia|"Ultrasound of Pregnant Females 18+ with pre-Eclampsia~Ultrasound: Ultrasound of the chest for the detection of fluid in the lung"
40144|NCT02357264|O2|Outcome|Pregnant Females With Suspicion of Pre-eclampsia|Pregnant females who the OB/GYN physician has suspicion that may have pre-eclampsia
40145|NCT02357264|O1|Outcome|Pregnant Females Without Pre-Eclampsia|Pregnant Females who the OB/GYN physician suspects do not have pre-eclampsia
40146|NCT02357264|E2|Reported Event|No Pre-eclampsia.|"Ultrasound of Pregnant Females 18+ with no pre-eclampsia~Ultrasound: Ultrasound of the chest for the detection of fluid in the lung"
40147|NCT02357264|E1|Reported Event|Pre-eclampsia|"Ultrasound of Pregnant Females 18+ with pre-Eclampsia~Ultrasound: Ultrasound of the chest for the detection of fluid in the lung"
40148|NCT02357173|B4|Baseline|Total|Total of all reporting groups
40149|NCT02357173|B3|Baseline|Control Group|This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose.
40150|NCT02357173|B2|Baseline|24 mg Electronic Nicotine Delivery Systems (ENDS)|"Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.~Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group."
40151|NCT02357173|B1|Baseline|16 mg Electronic Nicotine Delivery Systems (ENDS)|"Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.~Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group."
40152|NCT02357173|P3|Participant Flow|Control Group|This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose.
40153|NCT02357173|P2|Participant Flow|24 mg Electronic Nicotine Delivery Systems (ENDS)|"Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.~Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group."
40154|NCT02357173|P1|Participant Flow|16 mg Electronic Nicotine Delivery Systems (ENDS)|"Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.~Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group."
40155|NCT02357173|O3|Outcome|Control Group|This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose.
40156|NCT02357173|O2|Outcome|16 mg Electronic Nicotine Delivery Systems (ENDS)|"Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.~Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group."
40157|NCT02357173|O1|Outcome|24 mg Electronic Nicotine Delivery Systems (ENDS)|"Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.~Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group."
40158|NCT02357173|O3|Outcome|Control Group|This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose.
40159|NCT02357173|O2|Outcome|16 mg Electronic Nicotine Delivery Systems (ENDS)|"Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.~Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group."
40160|NCT02357173|O1|Outcome|24 mg Electronic Nicotine Delivery Systems (ENDS)|"Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.~Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group."
40161|NCT02357173|O3|Outcome|Control Group|This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose.
40162|NCT02357173|O2|Outcome|16 mg Electronic Nicotine Delivery Systems (ENDS)|"Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.~Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group."
40163|NCT02357173|O1|Outcome|24 mg Electronic Nicotine Delivery Systems (ENDS)|"Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.~Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group."
40164|NCT02357173|O3|Outcome|Control Group|This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose.
40165|NCT02357173|O2|Outcome|16 mg Electronic Nicotine Delivery Systems (ENDS)|"Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.~Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group."
40166|NCT02357173|O1|Outcome|24 mg Electronic Nicotine Delivery Systems (ENDS)|"Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.~Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group."
40167|NCT02357173|E3|Reported Event|Control Group|This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose.
40168|NCT02357173|E2|Reported Event|16 mg Electronic Nicotine Delivery Systems (ENDS)|"Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.~Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group."
40169|NCT02357173|E1|Reported Event|24 mg Electronic Nicotine Delivery Systems (ENDS)|"Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.~Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group."
40170|NCT02356900|B3|Baseline|Total|Total of all reporting groups
40171|NCT02356900|B2|Baseline|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.~Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
40172|NCT02356900|B1|Baseline|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.~Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.~Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
40173|NCT02356900|P2|Participant Flow|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.~Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
40193|NCT02356783|B1|Baseline|Interlaminar|"Approach for lumbar epidural steroid injection for this arm will be interlaminar.~We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes.~Pedometer: Wireless pedometer"
40174|NCT02356900|P1|Participant Flow|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.~Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.~Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
40175|NCT02356900|O2|Outcome|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.~Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
40176|NCT02356900|O1|Outcome|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.~Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.~Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
40177|NCT02356900|O2|Outcome|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.~Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
40178|NCT02356900|O1|Outcome|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.~Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.~Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
40179|NCT02356900|O2|Outcome|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.~Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
40180|NCT02356900|O1|Outcome|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.~Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.~Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
40181|NCT02356900|O2|Outcome|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.~Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
40182|NCT02356900|O1|Outcome|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.~Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.~Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
40183|NCT02356900|O2|Outcome|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.~Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
40184|NCT02356900|O1|Outcome|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.~Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.~Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
40185|NCT02356900|O2|Outcome|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.~Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
40186|NCT02356900|O1|Outcome|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.~Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.~Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
40187|NCT02356900|O2|Outcome|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.~Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
40188|NCT02356900|O1|Outcome|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.~Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.~Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
40189|NCT02356900|E2|Reported Event|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.~Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
40190|NCT02356900|E1|Reported Event|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.~Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.~Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
40191|NCT02356783|B3|Baseline|Total|Total of all reporting groups
40192|NCT02356783|B2|Baseline|Transforaminal|"Approach for lumbar epidural steroid injection for this arm will be transforaminal.~We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes.~Pedometer: Wireless pedometer"
67788|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
40194|NCT02356783|P2|Participant Flow|Transforaminal|"Approach for lumbar epidural steroid injection for this arm will be transforaminal.~We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes.~Pedometer: Wireless pedometer"
40195|NCT02356783|P1|Participant Flow|Interlaminar|"Approach for lumbar epidural steroid injection for this arm will be interlaminar.~We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes.~Pedometer: Wireless pedometer"
40196|NCT02356783|O2|Outcome|Transforaminal|"Approach for lumbar epidural steroid injection for this arm will be transforaminal.~We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes.~Pedometer: Wireless pedometer"
40197|NCT02356783|O1|Outcome|Interlaminar|"Approach for lumbar epidural steroid injection for this arm will be interlaminar.~We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes.~Pedometer: Wireless pedometer"
40198|NCT02356783|O2|Outcome|Transforaminal|"Approach for lumbar epidural steroid injection for this arm will be transforaminal.~We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes.~Pedometer: Wireless pedometer"
40199|NCT02356783|O1|Outcome|Interlaminar|"Approach for lumbar epidural steroid injection for this arm will be interlaminar.~We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes.~Pedometer: Wireless pedometer"
40200|NCT02356783|E2|Reported Event|Transforaminal|"Approach for lumbar epidural steroid injection for this arm will be transforaminal.~We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes.~Pedometer: Wireless pedometer"
40201|NCT02356783|E1|Reported Event|Interlaminar|"Approach for lumbar epidural steroid injection for this arm will be interlaminar.~We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes.~Pedometer: Wireless pedometer"
40202|NCT02356588|B3|Baseline|Total|Total of all reporting groups
40203|NCT02356588|B2|Baseline|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
40204|NCT02356588|B1|Baseline|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
40205|NCT02356588|P2|Participant Flow|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
40206|NCT02356588|P1|Participant Flow|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
40207|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
40208|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
40209|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
40210|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
40211|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
40270|NCT02355977|E3|Reported Event|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.~minocycline: Periocline dental ointment"
40212|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
40213|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
40214|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
40215|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
40216|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
40217|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
40218|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
40219|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
40220|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
40221|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
40222|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
40223|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
40224|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
40225|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
40322|NCT02355028|O2|Outcome|Vehicle|LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40226|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
40227|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
40228|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
40229|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
40230|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
40231|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
40232|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
40233|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
40234|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
40235|NCT02356588|E2|Reported Event|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
40236|NCT02356588|E1|Reported Event|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
40237|NCT02356562|B3|Baseline|Total|Total of all reporting groups
40238|NCT02356562|B2|Baseline|Part 2, 3-DAA With RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg QD and dasabuvir 250 mg BID) with RBV (weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 24 weeks
40239|NCT02356562|B1|Baseline|Part 1, 3-DAA With SOF With or Without RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) and sofosbuvir (SOF) 400 mg QD with or without ribavirin (RBV; weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 12 or 24 weeks
40240|NCT02356562|P2|Participant Flow|Part 2, 3-DAA With RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg QD and dasabuvir 250 mg BID) with RBV (weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 24 weeks
40241|NCT02356562|P1|Participant Flow|Part 1, 3-DAA With SOF With or Without RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) and sofosbuvir (SOF) 400 mg QD with or without ribavirin (RBV; weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 12 or 24 weeks
40242|NCT02356562|O2|Outcome|Part 2, 3-DAA With RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg QD and dasabuvir 250 mg BID) with RBV (weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 24 weeks
40243|NCT02356562|O1|Outcome|Part 1, 3-DAA With SOF With or Without RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) and sofosbuvir (SOF) 400 mg QD with or without ribavirin (RBV; weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 12 or 24 weeks
40244|NCT02356562|O2|Outcome|Part 2, 3-DAA With RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg QD and dasabuvir 250 mg BID) with RBV (weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 24 weeks
40245|NCT02356562|O1|Outcome|Part 1, 3-DAA With SOF With or Without RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) and sofosbuvir (SOF) 400 mg QD with or without ribavirin (RBV; weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 12 or 24 weeks
40246|NCT02356562|O1|Outcome|Part 2, 3-DAA With RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg QD and dasabuvir 250 mg BID) with RBV (weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 24 weeks
40247|NCT02356562|O1|Outcome|Part 1, 3-DAA With SOF With or Without RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) and sofosbuvir (SOF) 400 mg QD with or without ribavirin (RBV; weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 12 or 24 weeks
40248|NCT02356562|E2|Reported Event|Part 2, 3-DAA With RBV|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg QD and dasabuvir [250 mg BID) with RBV (weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 24 weeks.
40249|NCT02356562|E1|Reported Event|Part 1, 3-DAA With SOF With or Without RBV|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily [QD] and dasabuvir [250 mg twice daily [BID]) and sofosbuvir (SOF) 400 mg QD with or without ribavirin (RBV; weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 12 or 24 weeks.
40250|NCT02356107|B1|Baseline|Open Label Treatment With 5-HTP and Creatine|5-hydroxytryptophan and Creatine monohydrate
40251|NCT02356107|P1|Participant Flow|Open Label Treatment With 5-HTP and Creatine|5-hydroxytryptophan and Creatine monohydrate
40252|NCT02356107|O1|Outcome|Open Label Treatment With 5-HTP and Creatine|5-hydroxytryptophan and Creatine monohydrate
40253|NCT02356107|E1|Reported Event|Open Label Treatment With 5-HTP and Creatine|5-hydroxytryptophan and Creatine monohydrate
40254|NCT02355977|B4|Baseline|Total|Total of all reporting groups
40255|NCT02355977|B3|Baseline|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.~minocycline: Periocline dental ointment"
40256|NCT02355977|B2|Baseline|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth~minocycline: Periocline dental ointment~surface and root planning: surface and root planning"
40257|NCT02355977|B1|Baseline|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)~surface and root planning: surface and root planning"
40258|NCT02355977|P3|Participant Flow|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.~minocycline: Periocline dental ointment"
40259|NCT02355977|P2|Participant Flow|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth~minocycline: Periocline dental ointment~surface and root planning: surface and root planning"
40260|NCT02355977|P1|Participant Flow|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)~surface and root planning: surface and root planning"
40261|NCT02355977|O3|Outcome|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.~minocycline: Periocline dental ointment"
40262|NCT02355977|O2|Outcome|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth~minocycline: Periocline dental ointment~surface and root planning: surface and root planning"
40263|NCT02355977|O1|Outcome|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)~surface and root planning: surface and root planning"
40264|NCT02355977|O3|Outcome|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.~minocycline: Periocline dental ointment"
40265|NCT02355977|O2|Outcome|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth~minocycline: Periocline dental ointment~surface and root planning: surface and root planning"
40266|NCT02355977|O1|Outcome|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)~surface and root planning: surface and root planning"
40267|NCT02355977|O3|Outcome|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.~minocycline: Periocline dental ointment"
40268|NCT02355977|O2|Outcome|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth~minocycline: Periocline dental ointment~surface and root planning: surface and root planning"
40269|NCT02355977|O1|Outcome|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)~surface and root planning: surface and root planning"
42156|NCT02337062|E1|Reported Event|APD421 + Standard Anti-emetic|"Single dose of IV APD421~APD421"
40271|NCT02355977|E2|Reported Event|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth~minocycline: Periocline dental ointment~surface and root planning: surface and root planning"
40272|NCT02355977|E1|Reported Event|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)~surface and root planning: surface and root planning"
40273|NCT02355743|B1|Baseline|rtPA Lock Therapy Recipients|"rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks~rtPA lock therapy: rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks. rtPA will be given as research intervention as “lock therapy” in that it will dwell within the catheter of the CVAD for a specified duration of time and then be removed (aspirated); in this setting the medication is not given to the patient as a flush, i.e. in systemic fashion."
40274|NCT02355743|P1|Participant Flow|rtPA Lock Therapy Recipients|"rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks~rtPA lock therapy: rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks. rtPA will be given as research intervention as “lock therapy” in that it will dwell within the catheter of the CVAD for a specified duration of time and then be removed (aspirated); in this setting the medication is not given to the patient as a flush, i.e. in systemic fashion."
40275|NCT02355743|O1|Outcome|rtPA Lock Therapy Recipients|"rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks~rtPA lock therapy: rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks. rtPA will be given as research intervention as “lock therapy” in that it will dwell within the catheter of the CVAD for a specified duration of time and then be removed (aspirated); in this setting the medication is not given to the patient as a flush, i.e. in systemic fashion."
40276|NCT02355743|O1|Outcome|rtPA Lock Therapy Recipients|"rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks~rtPA lock therapy: rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks. rtPA will be given as research intervention as “lock therapy” in that it will dwell within the catheter of the CVAD for a specified duration of time and then be removed (aspirated); in this setting the medication is not given to the patient as a flush, i.e. in systemic fashion."
40277|NCT02355743|O1|Outcome|rtPA Lock Therapy Recipients|"rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks~rtPA lock therapy: rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks. rtPA will be given as research intervention as “lock therapy” in that it will dwell within the catheter of the CVAD for a specified duration of time and then be removed (aspirated); in this setting the medication is not given to the patient as a flush, i.e. in systemic fashion."
40278|NCT02355743|E1|Reported Event|rtPA Lock Therapy Recipients|"rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks~rtPA lock therapy: rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks. rtPA will be given as research intervention as “lock therapy” in that it will dwell within the catheter of the CVAD for a specified duration of time and then be removed (aspirated); in this setting the medication is not given to the patient as a flush, i.e. in systemic fashion."
40279|NCT02355691|B3|Baseline|Total|Total of all reporting groups
40280|NCT02355691|B2|Baseline|Standard Group|Patients will be treated with the standard absorptive dressing following total hip arthroplasty.
40281|NCT02355691|B1|Baseline|PREVENA Group|"Patients will be treated with the PREVENA negative pressure device following total hip arthroplasty. This dressing will be used for a period of seven days.~PREVENA: The device is a sealed negative pressure wound therapy tool. A single device is placed on the wound at the time of surgery. And removed at the time of the first postop visit around 7 days after surgery."
40282|NCT02355691|P2|Participant Flow|Standard Group|Patients will be treated with the standard absorptive dressing following total hip arthroplasty.
40283|NCT02355691|P1|Participant Flow|PREVENA Group|"Patients will be treated with the PREVENA negative pressure device following total hip arthroplasty. This dressing will be used for a period of seven days.~PREVENA: The device is a sealed negative pressure wound therapy tool. A single device is placed on the wound at the time of surgery. And removed at the time of the first postop visit around 7 days after surgery."
40284|NCT02355691|O2|Outcome|Standard Group|Patients will be treated with the standard absorptive dressing following total hip arthroplasty.
40285|NCT02355691|O1|Outcome|PREVENA Group|"Patients will be treated with the PREVENA negative pressure device following total hip arthroplasty. This dressing will be used for a period of seven days.~PREVENA: The device is a sealed negative pressure wound therapy tool. A single device is placed on the wound at the time of surgery. And removed at the time of the first postop visit around 7 days after surgery."
40286|NCT02355691|O2|Outcome|Standard Group|Patients will be treated with the standard absorptive dressing following total hip arthroplasty.
40287|NCT02355691|O1|Outcome|PREVENA Group|"Patients will be treated with the PREVENA negative pressure device following total hip arthroplasty. This dressing will be used for a period of seven days.~PREVENA: The device is a sealed negative pressure wound therapy tool. A single device is placed on the wound at the time of surgery. And removed at the time of the first postop visit around 7 days after surgery."
40288|NCT02355691|E2|Reported Event|Standard Group|Patients will be treated with the standard absorptive dressing following total hip arthroplasty.
40289|NCT02355691|E1|Reported Event|PREVENA Group|"Patients will be treated with the PREVENA negative pressure device following total hip arthroplasty. This dressing will be used for a period of seven days.~PREVENA: The device is a sealed negative pressure wound therapy tool. A single device is placed on the wound at the time of surgery. And removed at the time of the first postop visit around 7 days after surgery."
40290|NCT02355275|B1|Baseline|Home Exercise Program|Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
40291|NCT02355275|P1|Participant Flow|Home Exercise Program|Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
40292|NCT02355275|O1|Outcome|Home Exercise Program|Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
40293|NCT02355275|O1|Outcome|Home Exercise Program|Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
40294|NCT02355275|E1|Reported Event|Home Exercise Program|Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
40295|NCT02355158|B1|Baseline|Active|"Clonidine hydrochloride topical gel, 0.1%~clonidine hydrochloride topical gel, 0.1%"
40296|NCT02355158|P1|Participant Flow|Active|"Clonidine hydrochloride topical gel, 0.1%~clonidine hydrochloride topical gel, 0.1%"
40297|NCT02355158|O1|Outcome|Active|"Clonidine hydrochloride topical gel, 0.1%~clonidine hydrochloride topical gel, 0.1%"
40298|NCT02355158|E1|Reported Event|Active|"Clonidine hydrochloride topical gel, 0.1%~clonidine hydrochloride topical gel, 0.1%"
40299|NCT02355028|B3|Baseline|Total|Total of all reporting groups
40300|NCT02355028|B2|Baseline|Vehicle|LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40301|NCT02355028|B1|Baseline|LHA510|LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40302|NCT02355028|P2|Participant Flow|Vehicle|LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40303|NCT02355028|P1|Participant Flow|LHA510|LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40304|NCT02355028|O2|Outcome|CRA398|Metabolite of LHA510
40305|NCT02355028|O1|Outcome|LHA510|LHA510 dose twice daily (BID) by Day 28, LHA510 dose once daily (QD) by Day 84, LHA510 dose 3-times daily (TID) by Day 84
40306|NCT02355028|O2|Outcome|Vehicle|LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40307|NCT02355028|O1|Outcome|LHA510|LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40308|NCT02355028|O2|Outcome|Vehicle|LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40309|NCT02355028|O1|Outcome|LHA510|LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40310|NCT02355028|O2|Outcome|Vehicle|LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40311|NCT02355028|O1|Outcome|LHA510|LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40312|NCT02355028|O2|Outcome|Vehicle|LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40313|NCT02355028|O1|Outcome|LHA510|LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40314|NCT02355028|O2|Outcome|Vehicle|LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40315|NCT02355028|O1|Outcome|LHA510|LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40316|NCT02355028|O2|Outcome|Vehicle|LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40317|NCT02355028|O1|Outcome|LHA510|LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40318|NCT02355028|O2|Outcome|Vehicle|LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40319|NCT02355028|O1|Outcome|LHA510|LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40320|NCT02355028|O2|Outcome|Vehicle|LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40321|NCT02355028|O1|Outcome|LHA510|LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40323|NCT02355028|O1|Outcome|LHA510|LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40324|NCT02355028|O2|Outcome|Vehicle|LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40325|NCT02355028|O1|Outcome|LHA510|LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40326|NCT02355028|O2|Outcome|Vehicle|LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40327|NCT02355028|O1|Outcome|LHA510|LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40328|NCT02355028|O2|Outcome|Vehicle|LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40329|NCT02355028|O1|Outcome|LHA510|LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
40330|NCT02355028|E5|Reported Event|Post-treatment Vehicle|All subjects with AE/s having an onset more than 7 days after IP administration cessation through the study exit
40331|NCT02355028|E4|Reported Event|Post-treatment LHA510|All subjects with AE/s having an onset more than 7 days after IP administration cessation through the study exit
40332|NCT02355028|E3|Reported Event|Vehicle|All subjects with AE/s having an onset from IP initiation and up through 7 days after cessation of IP administration
40333|NCT02355028|E2|Reported Event|LHA510|All subjects with AE/s having an onset from IP initiation and up through 7 days after cessation of IP administration
40334|NCT02355028|E1|Reported Event|Pre-treatment|All subjects with AE/s reported prior to the initiation of IP administration
40335|NCT02354924|B3|Baseline|Total|Total of all reporting groups
40336|NCT02354924|B2|Baseline|Biofinity Soft Contact Lens|"Comfilcon A, Daily wear, monthly disposable soft contact lens~Biofinity soft contact lens: Biofinity soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
40337|NCT02354924|B1|Baseline|Visco Soft Contact Lens|"Olifilcon A, Daily wear, monthly disposable soft contact lens~Visco soft contact lens: Viso soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
40338|NCT02354924|P2|Participant Flow|Biofinity Soft Contact Lens|"Comfilcon A, Daily wear, monthly disposable soft contact lens~Biofinity soft contact lens: Biofinity soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
40339|NCT02354924|P1|Participant Flow|Visco Soft Contact Lens|"Olifilcon A, Daily wear, monthly disposable soft contact lens~Visco soft contact lens: Viso soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
40340|NCT02354924|O2|Outcome|Biofinity Soft Contact Lens|"Comfilcon A, Daily wear, monthly disposable soft contact lens~Biofinity soft contact lens: Biofinity soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
40341|NCT02354924|O1|Outcome|Visco Soft Contact Lens|"Olifilcon A, Daily wear, monthly disposable soft contact lens~Visco soft contact lens: Viso soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
40342|NCT02354924|O2|Outcome|Biofinity Soft Contact Lens|"Comfilcon A, Daily wear, monthly disposable soft contact lens~Biofinity soft contact lens: Biofinity soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
40343|NCT02354924|O1|Outcome|Visco Soft Contact Lens|"Olifilcon A, Daily wear, monthly disposable soft contact lens~Visco soft contact lens: Viso soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
40344|NCT02354924|O2|Outcome|Biofinity Soft Contact Lens|"Comfilcon A, Daily wear, monthly disposable soft contact lens~Biofinity soft contact lens: Biofinity soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
40345|NCT02354924|O1|Outcome|Visco Soft Contact Lens|"Olifilcon A, Daily wear, monthly disposable soft contact lens~Visco soft contact lens: Viso soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
40346|NCT02354924|E2|Reported Event|Biofinity Soft Contact Lens|"Comfilcon A, Daily wear, monthly disposable soft contact lens~Biofinity soft contact lens: Biofinity soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
40347|NCT02354924|E1|Reported Event|Visco Soft Contact Lens|"Olifilcon A, Daily wear, monthly disposable soft contact lens~Visco soft contact lens: Viso soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
40348|NCT02354833|B3|Baseline|Total|Total of all reporting groups
40349|NCT02354833|B2|Baseline|Norepinephrine|"A continuous norepinephrine infusion at 0.05 mcg/kg/min~Norepinephrine"
40350|NCT02354833|B1|Baseline|Phenylephrine|"A continuous phenylephrine infusion at 0.1 mcg/kg/min~Phenylephrine"
40351|NCT02354833|P2|Participant Flow|Norepinephrine|"A continuous norepinephrine infusion at 0.05 mcg/kg/min~Norepinephrine"
40352|NCT02354833|P1|Participant Flow|Phenylephrine|"A continuous phenylephrine infusion at 0.1 mcg/kg/min~Phenylephrine"
40353|NCT02354833|O2|Outcome|Norepinephrine|"A continuous norepinephrine infusion at 0.05 mcg/kg/min~Norepinephrine"
40354|NCT02354833|O1|Outcome|Phenylephrine|"A continuous phenylephrine infusion at 0.1 mcg/kg/min~Phenylephrine"
40355|NCT02354833|O2|Outcome|Norepinephrine|"A continuous norepinephrine infusion at 0.05 mcg/kg/min~Norepinephrine"
40356|NCT02354833|O1|Outcome|Phenylephrine|"A continuous phenylephrine infusion at 0.1 mcg/kg/min~Phenylephrine"
40357|NCT02354833|O2|Outcome|Norepinephrine|Cardiac Output as recorded by a non-invasive hemodynamic monitor
40358|NCT02354833|O1|Outcome|Phenylephrine|Cardiac Output as recorded by a non-invasive hemodynamic monitor
40359|NCT02354833|O2|Outcome|Norepinephrine|"A continuous norepinephrine infusion at 0.05 mcg/kg/min~Norepinephrine"
40360|NCT02354833|O1|Outcome|Phenylephrine|"A continuous phenylephrine infusion at 0.1 mcg/kg/min~Phenylephrine"
40361|NCT02354833|E2|Reported Event|Norepinephrine|Hypotension requiring a rescue bolus
40362|NCT02354833|E1|Reported Event|Phenylephrine|Hypotension requiring a rescue bolus
40363|NCT02354599|B7|Baseline|Total|Total of all reporting groups
40364|NCT02354599|B6|Baseline|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
40365|NCT02354599|B5|Baseline|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
40366|NCT02354599|B4|Baseline|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40367|NCT02354599|B3|Baseline|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40368|NCT02354599|B2|Baseline|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40369|NCT02354599|B1|Baseline|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40370|NCT02354599|P6|Participant Flow|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
40371|NCT02354599|P5|Participant Flow|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
40372|NCT02354599|P4|Participant Flow|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40373|NCT02354599|P3|Participant Flow|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40374|NCT02354599|P2|Participant Flow|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40375|NCT02354599|P1|Participant Flow|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40376|NCT02354599|O4|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
40377|NCT02354599|O3|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40378|NCT02354599|O2|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40379|NCT02354599|O1|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40380|NCT02354599|O6|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
40381|NCT02354599|O5|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40382|NCT02354599|O4|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
40383|NCT02354599|O3|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40384|NCT02354599|O2|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40385|NCT02354599|O1|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40386|NCT02354599|O4|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
40387|NCT02354599|O3|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40388|NCT02354599|O2|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40389|NCT02354599|O1|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40390|NCT02354599|O4|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
40391|NCT02354599|O3|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40392|NCT02354599|O2|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40393|NCT02354599|O1|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40394|NCT02354599|O4|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
40395|NCT02354599|O3|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40396|NCT02354599|O2|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40397|NCT02354599|O1|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40398|NCT02354599|O4|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
40399|NCT02354599|O3|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40400|NCT02354599|O2|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40401|NCT02354599|O1|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40402|NCT02354599|O6|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
40403|NCT02354599|O5|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
40404|NCT02354599|O4|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40405|NCT02354599|O3|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40406|NCT02354599|O2|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40407|NCT02354599|O1|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40408|NCT02354599|O6|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
40409|NCT02354599|O5|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
40410|NCT02354599|O4|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40411|NCT02354599|O3|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40412|NCT02354599|O2|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40413|NCT02354599|O1|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40414|NCT02354599|O6|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
40415|NCT02354599|O5|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
40416|NCT02354599|O4|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40417|NCT02354599|O3|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40418|NCT02354599|O2|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40419|NCT02354599|O1|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40420|NCT02354599|O6|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
40421|NCT02354599|O5|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
40422|NCT02354599|O4|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40423|NCT02354599|O3|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40424|NCT02354599|O2|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40425|NCT02354599|O1|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40426|NCT02354599|O6|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
40427|NCT02354599|O5|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
40428|NCT02354599|O4|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40429|NCT02354599|O3|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40430|NCT02354599|O2|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40431|NCT02354599|O1|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40432|NCT02354599|O6|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
40433|NCT02354599|O5|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
40434|NCT02354599|O4|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40435|NCT02354599|O3|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40436|NCT02354599|O2|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40437|NCT02354599|O1|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40438|NCT02354599|E6|Reported Event|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
40439|NCT02354599|E5|Reported Event|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
40440|NCT02354599|E4|Reported Event|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40441|NCT02354599|E3|Reported Event|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40442|NCT02354599|E2|Reported Event|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40443|NCT02354599|E1|Reported Event|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
40444|NCT02353871|B3|Baseline|Total|Total of all reporting groups
40445|NCT02353871|B2|Baseline|Placebo|Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
40446|NCT02353871|B1|Baseline|BTX-A-HAC NG Solution (50 U)|Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
40447|NCT02353871|P2|Participant Flow|Placebo|Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
40448|NCT02353871|P1|Participant Flow|BTX-A-HAC NG Solution (50 U)|Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
40449|NCT02353871|O2|Outcome|Placebo|Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
40450|NCT02353871|O1|Outcome|BTX-A-HAC NG Solution (50 U)|Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
40451|NCT02353871|O2|Outcome|Placebo|Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
40452|NCT02353871|O1|Outcome|BTX-A-HAC NG Solution (50 U)|Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
40453|NCT02353871|O2|Outcome|Placebo|Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
40454|NCT02353871|O1|Outcome|BTX-A-HAC NG Solution (50 U)|Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
40455|NCT02353871|O2|Outcome|Placebo|Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
40456|NCT02353871|O1|Outcome|BTX-A-HAC NG Solution (50 U)|Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
40457|NCT02353871|O2|Outcome|Placebo|Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
40458|NCT02353871|O1|Outcome|BTX-A-HAC NG Solution (50 U)|Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
40459|NCT02353871|O2|Outcome|Placebo|Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
40460|NCT02353871|O1|Outcome|BTX-A-HAC NG Solution (50 U)|Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
40461|NCT02353871|O2|Outcome|Placebo|Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
40462|NCT02353871|O1|Outcome|BTX-A-HAC NG Solution (50 U)|Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
40463|NCT02353871|O2|Outcome|Placebo|Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
40464|NCT02353871|O1|Outcome|BTX-A-HAC NG Solution (50 U)|Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
40465|NCT02353871|E2|Reported Event|Placebo|Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
40531|NCT02353299|O3|Outcome|Zolpidem 10 mg (ZOL-1.5H)|"zolpidem 10 mg single nightime dose - 1.5 hour arousability and cognitive assessments~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose"
42157|NCT02336958|B3|Baseline|Total|Total of all reporting groups
40466|NCT02353871|E1|Reported Event|BTX-A-HAC NG Solution (50 U)|Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
40467|NCT02353754|B3|Baseline|Total|Total of all reporting groups
40468|NCT02353754|B2|Baseline|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).~EXPAREL: 266 mg"
40469|NCT02353754|B1|Baseline|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.~Intrathecal morphine injection: 0.2 mg"
40470|NCT02353754|P2|Participant Flow|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).~EXPAREL: 266 mg"
40471|NCT02353754|P1|Participant Flow|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.~Intrathecal morphine injection: 0.2 mg"
40472|NCT02353754|O2|Outcome|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).~EXPAREL: 266 mg"
40473|NCT02353754|O1|Outcome|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.~Intrathecal morphine injection: 0.2 mg"
40474|NCT02353754|O2|Outcome|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).~EXPAREL: 266 mg"
40475|NCT02353754|O1|Outcome|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.~Intrathecal morphine injection: 0.2 mg"
40476|NCT02353754|O2|Outcome|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).~EXPAREL: 266 mg"
40477|NCT02353754|O1|Outcome|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.~Intrathecal morphine injection: 0.2 mg"
40478|NCT02353754|E2|Reported Event|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).~EXPAREL: 266 mg"
40479|NCT02353754|E1|Reported Event|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.~Intrathecal morphine injection: 0.2 mg"
40480|NCT02353572|B1|Baseline|Melphalan, Bortezomib, Autologous Transplant|Patients received melphalan IV continuously on days -5 to -2 and bortezomib IV over 3-5 seconds on days -4 and -1. Patients also received dexamethasone IV on day -1 prior to the second dose of bortezomib. Beginning two days after completion of melphalan infusion, patients underwent autologous hematopoietic stem cell transplant.
40481|NCT02353572|P1|Participant Flow|Melphalan, Bortezomib, Autologous Transplant|Patients received melphalan IV continuously on days -5 to -2 and bortezomib IV over 3-5 seconds on days -4 and -1. Patients also received dexamethasone IV on day -1 prior to the second dose of bortezomib. Beginning two days after completion of melphalan infusion, patients underwent autologous hematopoietic stem cell transplant.
40482|NCT02353572|O1|Outcome|Melphalan, Bortezomib, Autologous Transplant|Patients received melphalan IV continuously on days -5 to -2 and bortezomib IV over 3-5 seconds on days -4 and -1. Patients also received dexamethasone IV on day -1 prior to the second dose of bortezomib. Beginning two days after completion of melphalan infusion, patients underwent autologous hematopoietic stem cell transplant.
40483|NCT02353572|E1|Reported Event|Melphalan, Bortezomib, Autologous Transplant|Patients received melphalan IV continuously on days -5 to -2 and bortezomib IV over 3-5 seconds on days -4 and -1. Patients also received dexamethasone IV on day -1 prior to the second dose of bortezomib. Beginning two days after completion of melphalan infusion, patients underwent autologous hematopoietic stem cell transplant.
40484|NCT02353468|B1|Baseline|Enzyme Inhibitor, Biological Therapy, Chemotherapy|"CONSOLIDATION: Patients received VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity.~In between courses of VLD, patients received LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days.~MAINTENANCE: Starting in the third year of therapy, patients received lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Lenalidomide: Given PO~Dexamethasone: Given PO or IV"
40485|NCT02353468|P1|Participant Flow|Enzyme Inhibitor, Biological Therapy, Chemotherapy|"CONSOLIDATION: Patients received VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity.~In between courses of VLD, patients received LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days.~MAINTENANCE: Starting in the third year of therapy, patients received lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Lenalidomide: Given PO~Dexamethasone: Given PO or IV"
40748|NCT02349360|B3|Baseline|Total|Total of all reporting groups
67789|NCT02153489|O2|Outcome|Placebo|Placebo BID
40486|NCT02353468|O1|Outcome|Enzyme Inhibitor, Biological Therapy, Chemotherapy|"CONSOLIDATION: Patients received VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity.~In between courses of VLD, patients received LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days.~MAINTENANCE: Starting in the third year of therapy, patients received lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Lenalidomide: Given PO~Dexamethasone: Given PO or IV"
40487|NCT02353468|E1|Reported Event|Enzyme Inhibitor, Biological Therapy, Chemotherapy|"CONSOLIDATION: Patients received VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity.~In between courses of VLD, patients received LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days.~MAINTENANCE: Starting in the third year of therapy, patients received lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Lenalidomide: Given PO~Dexamethasone: Given PO or IV"
40488|NCT02353442|B3|Baseline|Total|Total of all reporting groups
40489|NCT02353442|B2|Baseline|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
40490|NCT02353442|B1|Baseline|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
40491|NCT02353442|P2|Participant Flow|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
40492|NCT02353442|P1|Participant Flow|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
40493|NCT02353442|O2|Outcome|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
40494|NCT02353442|O1|Outcome|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
40495|NCT02353442|O2|Outcome|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
40496|NCT02353442|O1|Outcome|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
40497|NCT02353442|O2|Outcome|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
40498|NCT02353442|O1|Outcome|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
40499|NCT02353442|O2|Outcome|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
40500|NCT02353442|O1|Outcome|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
40501|NCT02353442|O2|Outcome|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
40502|NCT02353442|O1|Outcome|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
40503|NCT02353442|E2|Reported Event|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
40504|NCT02353442|E1|Reported Event|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
40505|NCT02353299|B1|Baseline|All Study Participants|A single group of subjects were recruited and assigned all study treatments in random order
40506|NCT02353299|P4|Participant Flow|DXP-4H Then PBO-4H Then ZOL-1.5H Then PBO-1.5H|Period 1: Doxepin 6mg-single nighttime dose Period 2: Doxepin-matching placebo-single nighttime dose Period 3: Zolpidem 10mg-single nighttime dose Period 4: Zolpidem-matching placebo-single nighttime dose
40507|NCT02353299|P3|Participant Flow|ZOL-1.5H Then DXP-4H Then PBO-1.5H Then PBO-4H|Period 1: Zolpidem 10mg-single nighttime dose Period 2: Doxepin 6mg-single nighttime dose Period 3: Zolpidem-matching placebo-single nighttime dose Period 4: Doxepin-matching placebo-single nighttime dose
40508|NCT02353299|P2|Participant Flow|PBO-1.5H Then ZOL-1.5H Then PBO-4H Then DXP-4H|Period 1: Zolpidem-matching placebo-single nighttime dose Period 2: Zolpidem 10 mg-single nighttime dose Period 3: Doxepin-matching placebo-single nighttime dose Period 4: Doxepin 6mg-single nighttime dose
40509|NCT02353299|P1|Participant Flow|PBO-4H Then PBO-1.5H Then DXP-4H Then ZOL-1.5H|Period 1: Doxepin-matching placebo-single nighttime dose Period 2: Zolpidem-matching placebo-single nighttime dose Period 3: Doxepin 6mg-single nighttime dose Period 4: Zolpidem 10 mg-single nighttime dose
40510|NCT02353299|O4|Outcome|Placebo (PBO-1.5H)|"placebo single nightime dose -1.5 hour arousability and cognitive assessments~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose"
40511|NCT02353299|O3|Outcome|Zolpidem 10 mg (ZOL-1.5H)|"zolpidem 10 mg single nightime dose - 1.5 hour arousability and cognitive assessments~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose"
40512|NCT02353299|O2|Outcome|Placebo (PBO-4H)|"placebo single nightime dose -4 hour post dose arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose."
40513|NCT02353299|O1|Outcome|Silenor 6 mg (DXP-4H)|"Silenor 6 mg single nightime dose- 4 hour post dose arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose."
40514|NCT02353299|O4|Outcome|Placebo (PBO-1.5H)|"placebo single nightime dose -1.5 hour arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose.~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose~Placebo: placebo single nighttime dose-1.5 hours~Placebo: placebo single nighttime dose-4 hours"
40515|NCT02353299|O3|Outcome|Zolpidem 10 mg (ZOL-1.5H)|"zolpidem 10 mg single nightime dose - 1.5 hour arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose.~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose~Placebo: placebo single nighttime dose-1.5 hours~Placebo: placebo single nighttime dose-4 hours"
40516|NCT02353299|O2|Outcome|Placebo (PBO-4H)|"placebo single nightime dose -4 hour post dose arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose.~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose~Placebo: placebo single nighttime dose-1.5 hours~Placebo: placebo single nighttime dose-4 hours"
40517|NCT02353299|O1|Outcome|Silenor 6 mg (DXP-4H)|"Silenor 6 mg single nightime dose- 4 hour post dose arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose.~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose~Placebo: placebo single nighttime dose-1.5 hours~Placebo: placebo single nighttime dose-4 hours"
40518|NCT02353299|O4|Outcome|Placebo (PBO-1.5H)|"placebo single nightime dose -1.5 hour arousability and cognitive assessments~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose"
40519|NCT02353299|O3|Outcome|Zolpidem 10 mg (ZOL-1.5H)|"zolpidem 10 mg single nightime dose - 1.5 hour arousability and cognitive assessments~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose"
40520|NCT02353299|O2|Outcome|Placebo (PBO-4H)|"placebo single nightime dose -4 hour post dose arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose."
40521|NCT02353299|O1|Outcome|Silenor 6 mg (DXP-4H)|"Silenor 6 mg single nightime dose- 4 hour post dose arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose."
40522|NCT02353299|O4|Outcome|Placebo (PBO-1.5H)|"placebo single nightime dose -1.5 hour arousability and cognitive assessments~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose"
40523|NCT02353299|O3|Outcome|Zolpidem 10 mg (ZOL-1.5H)|"zolpidem 10 mg single nightime dose - 1.5 hour arousability and cognitive assessments~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose"
40524|NCT02353299|O2|Outcome|Placebo (PBO-4H)|"placebo single nightime dose -4 hour post dose arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose."
40525|NCT02353299|O1|Outcome|Silenor 6 mg (DXP-4H)|"Silenor 6 mg single nightime dose- 4 hour post dose arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose."
40526|NCT02353299|O4|Outcome|Placebo (PBO-1.5H)|"placebo single nightime dose -1.5 hour arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose.~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose~Placebo: placebo single nighttime dose-1.5 hours~Placebo: placebo single nighttime dose-4 hours"
40527|NCT02353299|O3|Outcome|Zolpidem 10 mg (ZOL-1.5H)|"zolpidem 10 mg single nightime dose - 1.5 hour arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose.~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose~Placebo: placebo single nighttime dose-1.5 hours~Placebo: placebo single nighttime dose-4 hours"
40528|NCT02353299|O2|Outcome|Silenor 6 mg (DXP-4H)|"Silenor 6 mg single nightime dose- 4 hour post dose arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose.~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose~Placebo: placebo single nighttime dose-1.5 hours~Placebo: placebo single nighttime dose-4 hours"
40529|NCT02353299|O1|Outcome|Placebo (PBO-4H)|"placebo single nightime dose -4 hour post dose arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose.~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose~Placebo: placebo single nighttime dose-1.5 hours~Placebo: placebo single nighttime dose-4 hours"
40530|NCT02353299|O4|Outcome|Placebo (PBO-1.5H)|"placebo single nightime dose -1.5 hour arousability and cognitive assessments~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose"
40532|NCT02353299|O2|Outcome|Silenor 6 mg (DXP-4H)|"Silenor 6 mg single nightime dose- 4 hour post dose arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose."
40533|NCT02353299|O1|Outcome|Placebo (PBO-4H)|"placebo single nightime dose -4 hour post dose arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose."
40534|NCT02353299|O4|Outcome|Placebo (PBO-1.5H)|"placebo single nightime dose -1.5 hour arousability and cognitive assessments~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose"
40535|NCT02353299|O3|Outcome|Zolpidem 10 mg (ZOL-1.5H)|"zolpidem 10 mg single nightime dose - 1.5 hour arousability and cognitive assessments~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose"
40536|NCT02353299|O2|Outcome|Placebo (PBO-4H)|"placebo single nightime dose -4 hour post dose arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose."
40537|NCT02353299|O1|Outcome|Silenor 6 mg (DXP-4H)|"Silenor 6 mg single nightime dose- 4 hour post dose arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose."
40538|NCT02353299|E4|Reported Event|Placebo (PBO-1.5H)|"placebo single nightime dose -1.5 hour arousability and cognitive assessments~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose"
40539|NCT02353299|E3|Reported Event|Zolpidem 10 mg (ZOL-1.5H)|"zolpidem 10 mg single nightime dose - 1.5 hour arousability and cognitive assessments~zolpidem 10 mg: Zolpidem 10 mg single nighttime dose"
40540|NCT02353299|E2|Reported Event|Placebo (PBO-4H)|"placebo single nightime dose -4 hour post dose arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose."
40541|NCT02353299|E1|Reported Event|Silenor 6 mg (DXP-4H)|"Silenor 6 mg single nightime dose- 4 hour post dose arousability and cognitive assessments~Silenor 6 mg: Silenor 6 mg single nighttime dose."
40542|NCT02352779|B4|Baseline|Total|Total of all reporting groups
40543|NCT02352779|B3|Baseline|Arm III (Placebo)|"Patients receive placebo PO BID for 6 weeks.~Placebo: Given PO~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
40544|NCT02352779|B2|Baseline|Arm II (High-dose Omega-3 Fatty Acid)|"Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.~Omega-3 Fatty Acid: Given PO~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
40545|NCT02352779|B1|Baseline|Arm I (Low-dose Omega-3 Fatty Acid)|"Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.~Omega-3 Fatty Acid: Given PO~Placebo: Given PO~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
40546|NCT02352779|P3|Participant Flow|Arm III (Placebo)|"Patients receive placebo PO BID for 6 weeks.~Placebo: Given PO~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
40547|NCT02352779|P2|Participant Flow|Arm II (High-dose Omega-3 Fatty Acid)|"Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.~Omega-3 Fatty Acid: Given PO~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
40548|NCT02352779|P1|Participant Flow|Arm I (Low-dose Omega-3 Fatty Acid)|"Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.~Omega-3 Fatty Acid: Given PO~Placebo: Given PO~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
40549|NCT02352779|O3|Outcome|Arm III (Placebo)|"Patients receive placebo PO BID for 6 weeks.~Placebo: Given PO~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
40550|NCT02352779|O2|Outcome|Arm II (High-dose Omega-3 Fatty Acid)|"Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.~Omega-3 Fatty Acid: Given PO~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
40551|NCT02352779|O1|Outcome|Arm I (Low-dose Omega-3 Fatty Acid)|"Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.~Omega-3 Fatty Acid: Given PO~Placebo: Given PO~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
40552|NCT02352779|E3|Reported Event|Arm III (Placebo)|"Patients receive placebo PO BID for 6 weeks.~Placebo: Given PO~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
40553|NCT02352779|E2|Reported Event|Arm II (High-dose Omega-3 Fatty Acid)|"Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.~Omega-3 Fatty Acid: Given PO~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
40554|NCT02352779|E1|Reported Event|Arm I (Low-dose Omega-3 Fatty Acid)|"Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.~Omega-3 Fatty Acid: Given PO~Placebo: Given PO~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
40555|NCT02352298|B1|Baseline|Dario and Yellow Springs Instrument|Blood obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System and the Yellow Springs Instrument for comparison.
40556|NCT02352298|P1|Participant Flow|Dario and Yellow Springs Instrument|Blood is obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System, blood glucose level is then also analyzed on the Yellow Springs Instrument for comparison.
40557|NCT02352298|O1|Outcome|Dario Blood Glucose Monitoring System|"Blood obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System~Dario Blood Glucose Monitoring System: Fingerstick to obtain blood sample for analysis with the Dario BGMS"
40558|NCT02352298|E2|Reported Event|YSI STAT|"Blood obtained via fingerstick and blood glucose level is tested on the YSI STAT for comparison to the results obtained with the Dario Blood Glucose Monitoring System~YSI Analyzer: Fingerstick to obtain blood sample for analysis with YSI"
40559|NCT02352298|E1|Reported Event|Dario Blood Glucose Monitoring System|"Blood obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System~Dario Blood Glucose Monitoring System: Fingerstick to obtain blood sample for analysis with the Dario BGMS"
40560|NCT02351960|B3|Baseline|Total|Total of all reporting groups
40561|NCT02351960|B2|Baseline|Dexlansoprazole 60 mg|Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
40562|NCT02351960|B1|Baseline|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).
41933|NCT02340000|O3|Outcome|Standard Dose Time Period 2|amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
40563|NCT02351960|P2|Participant Flow|Dexlansoprazole 60 mg|Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
40564|NCT02351960|P1|Participant Flow|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).
40565|NCT02351960|O1|Outcome|Dexlansoprazole 60 mg|Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
40566|NCT02351960|O2|Outcome|Dexlansoprazole 60 mg|Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
40567|NCT02351960|O1|Outcome|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).
40568|NCT02351960|O2|Outcome|Dexlansoprazole 60 mg|Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
40569|NCT02351960|O1|Outcome|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).
40570|NCT02351960|O2|Outcome|Dexlansoprazole 60 mg|Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
40571|NCT02351960|O1|Outcome|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).
40572|NCT02351960|O2|Outcome|Dexlansoprazole 60 mg|Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
40573|NCT02351960|O1|Outcome|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).
40574|NCT02351960|O2|Outcome|Dexlansoprazole 60 mg|Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
40575|NCT02351960|O1|Outcome|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).
40576|NCT02351960|O2|Outcome|Dexlansoprazole 60 mg|Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
40577|NCT02351960|O1|Outcome|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).
40578|NCT02351960|O1|Outcome|Dexlansoprazole 60 mg|Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
40579|NCT02351960|O1|Outcome|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).
40580|NCT02351960|E2|Reported Event|Dexlansoprazole 60 mg|Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
40581|NCT02351960|E1|Reported Event|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).
40582|NCT02351934|B3|Baseline|Total|Total of all reporting groups
40583|NCT02351934|B2|Baseline|Enhanced Recovery After Surgery (ERAS)|ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.
40584|NCT02351934|B1|Baseline|Furosemide + Enhanced Recovery After Surgery (ERAS)|Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
40585|NCT02351934|P2|Participant Flow|Enhanced Recovery After Surgery (ERAS)|ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.
40586|NCT02351934|P1|Participant Flow|Furosemide + Enhanced Recovery After Surgery (ERAS)|Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
40587|NCT02351934|O2|Outcome|Enhanced Recovery After Surgery (ERAS)|ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.
40588|NCT02351934|O1|Outcome|Furosemide + Enhanced Recovery After Surgery (ERAS)|Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
40589|NCT02351934|O2|Outcome|Enhanced Recovery After Surgery (ERAS)|ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.
40590|NCT02351934|O1|Outcome|Furosemide + Enhanced Recovery After Surgery (ERAS)|Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
44130|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
40591|NCT02351934|O2|Outcome|Enhanced Recovery After Surgery (ERAS)|ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.
40592|NCT02351934|O1|Outcome|Furosemide + Enhanced Recovery After Surgery (ERAS)|Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
40593|NCT02351934|O2|Outcome|Enhanced Recovery After Surgery (ERAS)|ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.
40594|NCT02351934|O1|Outcome|Furosemide + Enhanced Recovery After Surgery (ERAS)|Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
40595|NCT02351934|O2|Outcome|Enhanced Recovery After Surgery (ERAS)|ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.
40596|NCT02351934|O1|Outcome|Furosemide + Enhanced Recovery After Surgery (ERAS)|Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
40597|NCT02351934|O2|Outcome|Enhanced Recovery After Surgery (ERAS)|ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.
40598|NCT02351934|O1|Outcome|Furosemide + Enhanced Recovery After Surgery (ERAS)|Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
40599|NCT02351934|E2|Reported Event|Enhanced Recovery After Surgery (ERAS)|ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.
40600|NCT02351934|E1|Reported Event|Furosemide + Enhanced Recovery After Surgery (ERAS)|Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
40601|NCT02351817|B1|Baseline|Overall Study Population|The investigation is a cross-over investigation therefore baseline data is presented for the overall population
40602|NCT02351817|P2|Participant Flow|Baseline - Test B - Test A|"First each subject tests baseline product, then Test B and finally Test A.~Baseline product: the subject's usual product~Test A: A newly developed 1-piece, open ostomy appliance for collecting feces~Test B: A newly developed 1-piece, open ostomy appliance for collecting feces"
40603|NCT02351817|P1|Participant Flow|Baseline - Test A - Test B|"First each subject tests baseline product, then Test A and finally Test B.~Baseline product: the subject's usual product~Test A: A newly developed 1-piece, open ostomy appliance for collecting feces~Test B: A newly developed 1-piece, open ostomy appliance for collecting feces"
40604|NCT02351817|O2|Outcome|Test B|How many subjects preferred Test B over own product
40605|NCT02351817|O1|Outcome|Test A|How many subjects preferred Test A over own product
40606|NCT02351817|E3|Reported Event|Test B|Adverse events reported by subjects testing Test B
40607|NCT02351817|E2|Reported Event|Test A|Adverse events reported by subjects testing Test A
40608|NCT02351817|E1|Reported Event|Baseline|Adverse events reported by subjects testing Own product
40609|NCT02351505|B1|Baseline|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
40610|NCT02351505|P1|Participant Flow|Arm A: Selinexor (KPT-330)|"Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Pharmacological Study: Correlative studies"
40611|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
40612|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
40613|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
40614|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
40615|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
40616|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
40617|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
40618|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|"Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Pharmacological Study: Correlative studies"
40619|NCT02351505|E1|Reported Event|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
40620|NCT02350881|B1|Baseline|Overall Cohort|one consecutive series of patients were included
40621|NCT02350881|P1|Participant Flow|Overall Cohort|one consecutive series of patients were included
40622|NCT02350881|O2|Outcome|Revisions|Percentage of feet reoperated for implant ablation
40623|NCT02350881|O1|Outcome|Survival|Percentage of feet with implant still in place
40624|NCT02350881|O4|Outcome|Greater|Number of patients who declared a worsening of pain at rest postoperatively
40625|NCT02350881|O3|Outcome|Same|Number of patients who declared no improvement in pain at rest postoperatively
40626|NCT02350881|O2|Outcome|Less|Number of patients who declared a slight improvement of pain at rest postoperatively
40627|NCT02350881|O1|Outcome|Disappeared|Number of patients who declared an absence of pain at rest postoperatively
40628|NCT02350881|O4|Outcome|Greater|Number of patients who declared a worsening of pain during walking postoperatively
40629|NCT02350881|O3|Outcome|Same|Number of patients who declared no improvement in pain during walking postoperatively
40630|NCT02350881|O2|Outcome|Less|Number of patients who declared a slight improvement of pain during walking postoperatively
40631|NCT02350881|O1|Outcome|Disappeared|Number of patients who declared an absence of pain during walking postoperatively
40632|NCT02350881|O3|Outcome|Worsened|Number of patients who declared a worsening of their walking perimeter
40633|NCT02350881|O2|Outcome|Same|Number of patients who declared no improvement in their walking perimeter
40634|NCT02350881|O1|Outcome|Improved|Number of patients who declared an improvement in their walking perimeter
40635|NCT02350881|O3|Outcome|Severe|Number of patients reporting a severe pain
40636|NCT02350881|O2|Outcome|Moderate|umber of patients reporting a moderate pain
40637|NCT02350881|O1|Outcome|Absent|Number of patients reporting no pain
40638|NCT02350881|O2|Outcome|Presence|Number of feet where bone resorption was observed
40639|NCT02350881|O1|Outcome|Absence|Number of feet where no bone resorption was observed
40640|NCT02350881|O2|Outcome|Presence|Number of feet where osteolysis was observed
40641|NCT02350881|O1|Outcome|Absence|Number of feet where no osteolysis was observed
40642|NCT02350881|O3|Outcome|Severe|Number of patients reporting a severe pain
40643|NCT02350881|O2|Outcome|Moderate|Number of patients reporting a moderate pain
40644|NCT02350881|O1|Outcome|Absent|Number of patients reporting no pain
40645|NCT02350881|O1|Outcome|Overall Cohort|one consecutive series of patients were included
40646|NCT02350881|O1|Outcome|Overall Cohort|one consecutive series of patients were included
40647|NCT02350881|E1|Reported Event|Overall Cohort|one consecutive series of patients were included
40648|NCT02350569|B1|Baseline|Main Study (LDV/SOF 4 Weeks)|One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection
40649|NCT02350569|P1|Participant Flow|LDV/SOF|"LDV/SOF for 1 Day: 3 participants were called for transplant, received one dose of ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg), but had their liver transplant cancelled. All 3 participants were rescreened and 2 were subsequently re-enrolled, transplanted, and continued into the Main Study.~Main Study (LDV/SOF 4 Weeks): One dose of ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 hepatitis C virus (HCV) infection.~Retreatment (LDV/SOF 12 Weeks): Participants who completed treatment in the Main Study and experienced virologic failure had the option to be retreated with LDV/SOF for 12 weeks."
40650|NCT02350569|O1|Outcome|Main Study (LDV/SOF 4 Weeks)|One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection
40651|NCT02350569|O1|Outcome|Main Study (LDV/SOF 4 Weeks)|One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection
40652|NCT02350569|O1|Outcome|Main Study (LDV/SOF 4 Weeks)|One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection
40653|NCT02350569|O1|Outcome|Main Study (LDV/SOF 4 Weeks)|One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection
40654|NCT02350569|O1|Outcome|Main Study (LDV/SOF 4 Weeks)|One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection
40655|NCT02350569|E3|Reported Event|Retreatment (LDV/SOF 12 Weeks)|Adverse events reported in this group include 1 participant who completed treatment and experienced virologic failure in the Main Study and was retreated with an additional 12 weeks of LDV/SOF.
40656|NCT02350569|E2|Reported Event|Main Study (LDV/SOF 4 Weeks)|Adverse events reported in this group include participants with chronic genotype 1 HCV infection who received one dose of LDV/SOF (90/400 mg) prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant.
40657|NCT02350569|E1|Reported Event|LDV/SOF for 1 Day|Adverse events reported in this group include participants who received LDV/SOF on Day -1, but did not receive a liver transplant. All 3 participants were rescreened, but only 2 were re-enrolled, transplanted, and received LDV/SOF for 4 weeks.
40658|NCT02349711|B3|Baseline|Total|Total of all reporting groups
40659|NCT02349711|B2|Baseline|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
40660|NCT02349711|B1|Baseline|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
40661|NCT02349711|P2|Participant Flow|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
40662|NCT02349711|P1|Participant Flow|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
40663|NCT02349711|O2|Outcome|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
40664|NCT02349711|O1|Outcome|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
40665|NCT02349711|O2|Outcome|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
40666|NCT02349711|O1|Outcome|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
40667|NCT02349711|O2|Outcome|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
40668|NCT02349711|O1|Outcome|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
40669|NCT02349711|O2|Outcome|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
40670|NCT02349711|O1|Outcome|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
40671|NCT02349711|E2|Reported Event|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
40672|NCT02349711|E1|Reported Event|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
40673|NCT02349685|B4|Baseline|Total|Total of all reporting groups
40674|NCT02349685|B3|Baseline|14 Day Tailored Therapy Group|based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.
40675|NCT02349685|B2|Baseline|14 Day MEA Group|"PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.~14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)"
40676|NCT02349685|B1|Baseline|14 Day PBMT Group|"Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d~14 day PBMT group: Rescue therapy using 14 day PBMT regimen [Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d]"
40677|NCT02349685|P3|Participant Flow|14 Day Tailored Therapy Group|based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.
40678|NCT02349685|P2|Participant Flow|14 Day MEA Group|"PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.~14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)"
40749|NCT02349360|B2|Baseline|Placebo|"Encapsulated starch placebo administered for 8 weeks~Placebo: Encapsulated starch placebo administered for 8 weeks"
40750|NCT02349360|B1|Baseline|Probiotic|"L. johnsonii N6.2 10^10 CFU in capsule form administered for 8 weeks~L. johnsonii N6.2: L. johnsonii N6.2 10^10 CFU in capsule form administered for 8 weeks"
40679|NCT02349685|P1|Participant Flow|14 Day PBMT Group|"Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d~14 day PBMT group: Rescue therapy using 14 day PBMT regimen [Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d]"
40680|NCT02349685|O3|Outcome|14 Day Tailored Therapy Group|"based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.~H. pylori culture and antimicrobial susceptibility test: Antral and body biopsy specimens were evaluated separately. Organisms were identified as H. pylori by Gram staining, colony morphology, and positive oxidase, catalase, and urease reactions. Minimum inhibitory concentrations (MICs) were determined by the agar dilution method. Amoxicillin (Sigma Chemical Co., St. Louis, Mo.), clarithromycin (Abbott Laboratories, Abbott Park, Ill.), metronidazole (Sigma), tetracycline (Sigma) and moxifloxacin (Sigma) for the H. pylori isolates were examined by use of the serial twofold agar dilution method and the reference of susceptibility testing was according to the recommendations of the Clinical and Laboratory Standards Institute."
40681|NCT02349685|O2|Outcome|14 Day MEA Group|"PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.~14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)"
40682|NCT02349685|O1|Outcome|14 Day PBMT Group|"Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d~14 day PBMT group: Rescue therapy using 14 day PBMT regimen [Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d]"
40683|NCT02349685|O3|Outcome|14 Day Tailored Therapy Group|"based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.~H. pylori culture and antimicrobial susceptibility test: Antral and body biopsy specimens were evaluated separately. Organisms were identified as H. pylori by Gram staining, colony morphology, and positive oxidase, catalase, and urease reactions. Minimum inhibitory concentrations (MICs) were determined by the agar dilution method. Amoxicillin (Sigma Chemical Co., St. Louis, Mo.), clarithromycin (Abbott Laboratories, Abbott Park, Ill.), metronidazole (Sigma), tetracycline (Sigma) and moxifloxacin (Sigma) for the H. pylori isolates were examined by use of the serial twofold agar dilution method and the reference of susceptibility testing was according to the recommendations of the Clinical and Laboratory Standards Institute."
40684|NCT02349685|O2|Outcome|14 Day MEA Group|"PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.~14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)"
40685|NCT02349685|O1|Outcome|14 Day PBMT Group|"Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d~14 day PBMT group: Rescue therapy using 14 day PBMT regimen [Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d]"
40686|NCT02349685|E3|Reported Event|14 Day Tailored Therapy Group|based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.
40687|NCT02349685|E2|Reported Event|14 Day MEA Group|"PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.~14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)"
40688|NCT02349685|E1|Reported Event|14 Day PBMT Group|"Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d~14 day PBMT group: Rescue therapy using 14 day PBMT regimen [Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d]"
40689|NCT02349542|B1|Baseline|Liposomal Bupivacaine|"Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty.~Liposomal bupivacaine: One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site."
40690|NCT02349542|P1|Participant Flow|Liposomal Bupivacaine|"Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty.~Liposomal bupivacaine: One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site."
40691|NCT02349542|O1|Outcome|Liposomal Bupivacaine|"Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty.~Liposomal bupivacaine: One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site."
40692|NCT02349542|O1|Outcome|Liposomal Bupivacaine|"Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty.~Liposomal bupivacaine: One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site."
40693|NCT02349542|E1|Reported Event|Liposomal Bupivacaine|"Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty.~Liposomal bupivacaine: One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site."
40694|NCT02349451|B5|Baseline|Total|Total of all reporting groups
40695|NCT02349451|B4|Baseline|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
40696|NCT02349451|B3|Baseline|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
40697|NCT02349451|B2|Baseline|Adalimumab 40 mg EOW|Double-blind adalimumab 40 mg administered EOW for 12 weeks
40698|NCT02349451|B1|Baseline|Placebo EW|Double-blind placebo administered EW for 12 weeks
40699|NCT02349451|P4|Participant Flow|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
40700|NCT02349451|P3|Participant Flow|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
40701|NCT02349451|P2|Participant Flow|Adalimumab 40 mg EOW|Double-blind adalimumab 40 mg administered every other week (EOW) for 12 weeks
40702|NCT02349451|P1|Participant Flow|Placebo EW|Double-blind placebo administered every week (EW) for 12 weeks
40703|NCT02349451|O4|Outcome|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
40704|NCT02349451|O3|Outcome|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
40705|NCT02349451|O2|Outcome|Adalimumab 40 mg EOW|Double-blind adalimumab 40 mg administered EOW for 12 weeks
40706|NCT02349451|O1|Outcome|Placebo EW|Double-blind placebo administered EW for 12 weeks
40707|NCT02349451|O4|Outcome|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
40708|NCT02349451|O3|Outcome|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
40709|NCT02349451|O2|Outcome|Adalimumab 40 mg EOW|Double-blind adalimumab 40 mg administered EOW for 12 weeks
40710|NCT02349451|O1|Outcome|Placebo EW|Double-blind placebo administered EW for 12 weeks
40711|NCT02349451|O4|Outcome|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
40712|NCT02349451|O3|Outcome|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
40713|NCT02349451|O2|Outcome|Adalimumab 40 mg EOW|Double-blind adalimumab 40 mg administered EOW for 12 weeks
40714|NCT02349451|O1|Outcome|Placebo EW|Double-blind placebo administered EW for 12 weeks
40715|NCT02349451|O4|Outcome|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
40716|NCT02349451|O3|Outcome|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
40717|NCT02349451|O2|Outcome|Adalimumab 40 mg EOW|Double-blind adalimumab 40 mg administered EOW for 12 weeks
40718|NCT02349451|O1|Outcome|Placebo EW|Double-blind placebo administered EW for 12 weeks
40719|NCT02349451|O4|Outcome|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
40720|NCT02349451|O3|Outcome|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
40721|NCT02349451|O2|Outcome|Adalimumab 40 mg EOW|Double-blind adalimumab 40 mg administered EOW for 12 weeks
40722|NCT02349451|O1|Outcome|Placebo EW|Double-blind placebo administered EW for 12 weeks
40723|NCT02349451|O4|Outcome|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
40724|NCT02349451|O3|Outcome|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
40725|NCT02349451|O2|Outcome|Adalimumab 40 mg EOW|Double-blind adalimumab 40 mg administered EOW for 12 weeks
40726|NCT02349451|O1|Outcome|Placebo EW|Double-blind placebo administered EW for 12 weeks
40727|NCT02349451|O3|Outcome|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
40728|NCT02349451|O2|Outcome|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
40729|NCT02349451|O1|Outcome|Adalimumab 40 mg EOW|Double-blind adalimumab 40 mg administered EOW for 12 weeks
40730|NCT02349451|O3|Outcome|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
40731|NCT02349451|O2|Outcome|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
40732|NCT02349451|O1|Outcome|Placebo EW|Double-blind placebo administered EW for 12 weeks
40733|NCT02349451|E4|Reported Event|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
40734|NCT02349451|E3|Reported Event|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
40735|NCT02349451|E2|Reported Event|Adalimumab 40 mg EOW|Double-blind adalimumab 40 mg administered EOW for 12 weeks
40736|NCT02349451|E1|Reported Event|Placebo EW|Double-blind placebo administered EW for 12 weeks
40737|NCT02349438|B1|Baseline|Dispensed|All subjects that were dispensed at least 1 study lens during the course of the study.
40738|NCT02349438|P2|Participant Flow|Lotrafilcon B/Senofilcon A|Subjects that were randomized to receive the lotrafilcon B lens first and then to receive the senofilcon A lens.
40739|NCT02349438|P1|Participant Flow|Senofilcon A/Lotrafilcon B|Subjects that were randomized to receive the senofilcon A lens first and then to receive the lotrafilcon B lens.
40740|NCT02349438|O2|Outcome|Lotrafilcon B|Subject that wore the lotrafilcon B in either the 1st or 2nd period of the study.
40741|NCT02349438|O1|Outcome|Senofilcon A|Subjects that wore the senofilcon A lens in either the 1st or 2nd period of the study.
40742|NCT02349438|O2|Outcome|Lotrafilcon B|Subject that wore the lotrafilcon B in either the 1st or 2nd period of the study.
40743|NCT02349438|O1|Outcome|Senofilcon A|Subjects that wore the senofilcon A lens in either the 1st or 2nd period of the study.
40744|NCT02349438|O2|Outcome|Lotrafilcon B|Subject that wore the lotrafilcon B in either the 1st or 2nd period of the study.
40745|NCT02349438|O1|Outcome|Senofilcon A|Subjects that wore the senofilcon A lens in either the 1st or 2nd period of the study.
40746|NCT02349438|E2|Reported Event|Lotrafilcon B|Subject that wore the lotrafilcon B in either the 1st or 2nd period of the study.
40747|NCT02349438|E1|Reported Event|Senofilcon A|Subjects that wore the senofilcon A lens in either the 1st or 2nd period of the study.
40751|NCT02349360|P2|Participant Flow|Placebo|"Encapsulated starch placebo administered for 8 weeks~Placebo: Encapsulated starch placebo administered for 8 weeks"
40752|NCT02349360|P1|Participant Flow|Probiotic|"L. johnsonii N6.2 in capsule form administered for 8 weeks~L. johnsonii N6.2: L. johnsonii N6.2 in capsule form administered for 8 weeks"
40753|NCT02349360|O2|Outcome|Placebo|"Encapsulated starch placebo administered for 8 weeks~Placebo: Encapsulated starch placebo administered for 8 weeks"
40754|NCT02349360|O1|Outcome|Probiotic|"L. johnsonii N6.2 10^10 CFU in capsule form administered for 8 weeks~L. johnsonii N6.2: L. johnsonii N6.2 10^10 CFU in capsule form administered for 8 weeks ("
40755|NCT02349360|O2|Outcome|Placebo|"Encapsulated starch placebo administered for 8 weeks~Placebo: Encapsulated starch placebo administered for 8 weeks"
40756|NCT02349360|O1|Outcome|Probiotic|"L. johnsonii N6.2 10^10 CFU in capsule form administered for 8 weeks~L. johnsonii N6.2: L. johnsonii N6.2 10^10 CFU in capsule form administered for 8 weeks ("
40757|NCT02349360|E2|Reported Event|Placebo|"Encapsulated starch placebo administered for 8 weeks~Placebo: Encapsulated starch placebo administered for 8 weeks"
40758|NCT02349360|E1|Reported Event|Probiotic|"L. johnsonii N6.2 10^10 CFU in capsule form administered for 8 weeks~L. johnsonii N6.2: L. johnsonii N6.2 10^10 CFU in capsule form administered for 8 weeks"
40759|NCT02349295|B4|Baseline|Total|Total of all reporting groups
40760|NCT02349295|B3|Baseline|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40761|NCT02349295|B2|Baseline|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
40762|NCT02349295|B1|Baseline|Placebo|Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40763|NCT02349295|P5|Participant Flow|IR IxeQ2W|Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q2W and IR from ixekizumab 80 mg Q2W who continued on ixekizumab 80 mg Q2W. Patients receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20, 22, and 24.
40764|NCT02349295|P4|Participant Flow|IR IxeQ4W|Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q4W and IR from ixekizumab 80 mg Q4W who continued on ixekizumab 80 mg Q4W. Patients receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22.
40765|NCT02349295|P3|Participant Flow|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22, and 24.
40766|NCT02349295|P2|Participant Flow|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14, 18, and 22.
40767|NCT02349295|P1|Participant Flow|Placebo|Participants received placebo for ixekizumab as 2 subcutaneous (SC) injections followed by 1 SC injection every 2 Weeks (Q2W) given on Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24.
40768|NCT02349295|O2|Outcome|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40769|NCT02349295|O1|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
40770|NCT02349295|O2|Outcome|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40771|NCT02349295|O1|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
40914|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
40772|NCT02349295|O3|Outcome|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40773|NCT02349295|O2|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
40774|NCT02349295|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40775|NCT02349295|O3|Outcome|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40776|NCT02349295|O2|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
40777|NCT02349295|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40778|NCT02349295|O3|Outcome|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40779|NCT02349295|O2|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
40780|NCT02349295|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40781|NCT02349295|O3|Outcome|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40782|NCT02349295|O2|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
40783|NCT02349295|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40784|NCT02349295|O3|Outcome|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40915|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
40785|NCT02349295|O2|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
40786|NCT02349295|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40787|NCT02349295|O3|Outcome|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40788|NCT02349295|O2|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
40789|NCT02349295|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40790|NCT02349295|O3|Outcome|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40791|NCT02349295|O2|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
40792|NCT02349295|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40793|NCT02349295|O3|Outcome|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40794|NCT02349295|O2|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
40795|NCT02349295|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40796|NCT02349295|O3|Outcome|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40853|NCT02349152|O2|Outcome|Fentanyl Group|"Half of subjects enrolled will be randomized to the fentanyl group~Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery."
40857|NCT02349152|O2|Outcome|Fentanyl Group|"Half of subjects enrolled will be randomized to the fentanyl group~Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery."
40797|NCT02349295|O2|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
40798|NCT02349295|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40799|NCT02349295|O3|Outcome|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40800|NCT02349295|O2|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
40801|NCT02349295|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40802|NCT02349295|O3|Outcome|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40803|NCT02349295|O2|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
40804|NCT02349295|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40805|NCT02349295|O3|Outcome|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40806|NCT02349295|O2|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
40807|NCT02349295|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40808|NCT02349295|O3|Outcome|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40854|NCT02349152|O1|Outcome|Remifentanil Group|"Half of subjects enrolled will be randomized to the remifentanil group~Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated."
40916|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
40809|NCT02349295|O2|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
40810|NCT02349295|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40811|NCT02349295|O3|Outcome|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40812|NCT02349295|O2|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
40813|NCT02349295|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40814|NCT02349295|O3|Outcome|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40815|NCT02349295|O2|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
40816|NCT02349295|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40817|NCT02349295|O3|Outcome|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40818|NCT02349295|O2|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
40819|NCT02349295|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40820|NCT02349295|O3|Outcome|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40855|NCT02349152|O2|Outcome|Fentanyl Group|"Half of subjects enrolled will be randomized to the fentanyl group~Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery."
40881|NCT02349048|O1|Outcome|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
40821|NCT02349295|O2|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
40822|NCT02349295|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40823|NCT02349295|O3|Outcome|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40824|NCT02349295|O2|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
40825|NCT02349295|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40826|NCT02349295|O3|Outcome|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40827|NCT02349295|O2|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
40828|NCT02349295|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40829|NCT02349295|O3|Outcome|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40830|NCT02349295|O2|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
40831|NCT02349295|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40832|NCT02349295|O3|Outcome|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40856|NCT02349152|O1|Outcome|Remifentanil Group|"Half of subjects enrolled will be randomized to the remifentanil group~Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated."
40913|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
40833|NCT02349295|O2|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
40834|NCT02349295|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
40835|NCT02349295|E5|Reported Event|IR IxeQ2W|Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q2W and IR from ixekizumab 80 mg Q2W who continued on ixekizumab 80 mg Q2W. Patients receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20, 22, and 24.
40836|NCT02349295|E4|Reported Event|IR IxeQ4W|Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q4W and IR from ixekizumab 80 mg Q4W who continued on ixekizumab 80 mg Q4W. Patients receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22.
40837|NCT02349295|E3|Reported Event|Ixekizumab 80 mg Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12, and 14, 16, 18, 20, 22, and 24.
40838|NCT02349295|E2|Reported Event|Ixekizumab 80 mg Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14, 18, and 22.
40839|NCT02349295|E1|Reported Event|Placebo|Participants received placebo for ixekizumab as 2 subcutaneous (SC) injections followed by 1 SC injection every 2 Weeks (Q2W) given on Weeks 2, 4, 6, 8, 10, 12 and 14, 16, 18, 20, 22, and 24.
40840|NCT02349152|B3|Baseline|Total|Total of all reporting groups
40841|NCT02349152|B2|Baseline|Fentanyl Group|"Half of subjects enrolled will be randomized to the fentanyl group~Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery."
40842|NCT02349152|B1|Baseline|Remifentanil Group|"Half of subjects enrolled will be randomized to the remifentanil group~Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated."
40843|NCT02349152|P2|Participant Flow|Fentanyl Group|"Half of subjects enrolled will be randomized to the fentanyl group~Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery."
40844|NCT02349152|P1|Participant Flow|Remifentanil Group|"Half of subjects enrolled will be randomized to the remifentanil group~Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated."
40845|NCT02349152|O2|Outcome|Fentanyl Group|"Half of subjects enrolled will be randomized to the fentanyl group~Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery."
40846|NCT02349152|O1|Outcome|Remifentanil Group|"Half of subjects enrolled will be randomized to the remifentanil group~Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated."
40847|NCT02349152|O2|Outcome|Fentanyl Group|"Half of subjects enrolled will be randomized to the fentanyl group~Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery."
40848|NCT02349152|O1|Outcome|Remifentanil Group|"Half of subjects enrolled will be randomized to the remifentanil group~Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated."
40849|NCT02349152|O2|Outcome|Fentanyl Group|"Half of subjects enrolled will be randomized to the fentanyl group~Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery."
40850|NCT02349152|O1|Outcome|Remifentanil Group|"Half of subjects enrolled will be randomized to the remifentanil group~Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated."
40851|NCT02349152|O2|Outcome|Fentanyl Group|"Half of subjects enrolled will be randomized to the fentanyl group~Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery."
40852|NCT02349152|O1|Outcome|Remifentanil Group|"Half of subjects enrolled will be randomized to the remifentanil group~Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated."
67790|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
40858|NCT02349152|O1|Outcome|Remifentanil Group|"Half of subjects enrolled will be randomized to the remifentanil group~Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated."
40859|NCT02349152|O2|Outcome|Fentanyl Group|"Half of subjects enrolled will be randomized to the fentanyl group~Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery."
40860|NCT02349152|O1|Outcome|Remifentanil Group|"Half of subjects enrolled will be randomized to the remifentanil group~Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated."
40861|NCT02349152|O2|Outcome|Fentanyl Group|"Half of subjects enrolled will be randomized to the fentanyl group~Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery."
40862|NCT02349152|O1|Outcome|Remifentanil Group|"Half of subjects enrolled will be randomized to the remifentanil group~Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated."
40863|NCT02349152|O2|Outcome|Fentanyl Group|"Half of subjects enrolled will be randomized to the fentanyl group~Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery."
40864|NCT02349152|O1|Outcome|Remifentanil Group|"Half of subjects enrolled will be randomized to the remifentanil group~Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated."
40865|NCT02349152|E2|Reported Event|Fentanyl Group|"Half of subjects enrolled will be randomized to the fentanyl group~Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery."
40866|NCT02349152|E1|Reported Event|Remifentanil Group|"Half of subjects enrolled will be randomized to the remifentanil group~Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated."
40867|NCT02349048|B3|Baseline|Total|Total of all reporting groups
40868|NCT02349048|B2|Baseline|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
40869|NCT02349048|B1|Baseline|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
40870|NCT02349048|P2|Participant Flow|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
40871|NCT02349048|P1|Participant Flow|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
40872|NCT02349048|O2|Outcome|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
40873|NCT02349048|O1|Outcome|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
40874|NCT02349048|O2|Outcome|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
40875|NCT02349048|O1|Outcome|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
40876|NCT02349048|O2|Outcome|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
40877|NCT02349048|O1|Outcome|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
40878|NCT02349048|O2|Outcome|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
40879|NCT02349048|O1|Outcome|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
40880|NCT02349048|O2|Outcome|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
40882|NCT02349048|O2|Outcome|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
40883|NCT02349048|O1|Outcome|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
40884|NCT02349048|O2|Outcome|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
40885|NCT02349048|O1|Outcome|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
40886|NCT02349048|O2|Outcome|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
40887|NCT02349048|O1|Outcome|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
40888|NCT02349048|E2|Reported Event|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
40889|NCT02349048|E1|Reported Event|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
40890|NCT02348723|B3|Baseline|Total|Total of all reporting groups
40891|NCT02348723|B2|Baseline|Warfarin|"Patients receiving Warfarin tablet orally;~1, 3, and 5 mg (dose adjusted to International normalized ratio (INR) target range)"
40892|NCT02348723|B1|Baseline|Dabigatran Etexilate 150 mg|"Patients receiving Dabigatran Etexilate 150 mg capsule orally twice daily (BID);~1 capsule 150 mg twice daily (total daily dose 300 mg)"
40893|NCT02348723|P2|Participant Flow|Warfarin|"Patients receiving Warfarin tablet orally;~1, 3, and 5 mg (dose adjusted to International normalized ratio (INR) target range)"
40894|NCT02348723|P1|Participant Flow|Dabigatran Etexilate 150 mg|"Patients receiving Dabigatran Etexilate 150 mg capsule orally twice daily (BID);~1 capsule 150 mg twice daily (total daily dose 300 mg)"
40895|NCT02348723|O2|Outcome|Warfarin|"Patients receiving Warfarin tablet orally;~1, 3, and 5 mg (dose adjusted to International normalized ratio (INR) target range)"
40896|NCT02348723|O1|Outcome|Dabigatran Etexilate 150 mg|"Patients receiving Dabigatran Etexilate 150 mg capsule orally twice daily (BID);~1 capsule 150 mg twice daily (total daily dose 300 mg)"
40897|NCT02348723|O2|Outcome|Warfarin|"Patients receiving Warfarin tablet orally;~1, 3, and 5 mg (dose adjusted to International normalized ratio (INR) target range)"
40898|NCT02348723|O1|Outcome|Dabigatran Etexilate 150 mg|"Patients receiving Dabigatran Etexilate 150 mg capsule orally twice daily (BID);~1 capsule 150 mg twice daily (total daily dose 300 mg)"
40899|NCT02348723|O2|Outcome|Warfarin|"Patients receiving Warfarin tablet orally;~1, 3, and 5 mg (dose adjusted to International normalized ratio (INR) target range)"
40900|NCT02348723|O1|Outcome|Dabigatran Etexilate 150 mg|"Patients receiving Dabigatran Etexilate 150 mg capsule orally twice daily (BID);~1 capsule 150 mg twice daily (total daily dose 300 mg)"
40901|NCT02348723|O2|Outcome|Warfarin|"Patients receiving Warfarin tablet orally;~1, 3, and 5 mg (dose adjusted to International normalized ratio (INR) target range)"
40902|NCT02348723|O1|Outcome|Dabigatran Etexilate 150 mg|"Patients receiving Dabigatran Etexilate 150 mg capsule orally twice daily (BID);~1 capsule 150 mg twice daily (total daily dose 300 mg)"
40903|NCT02348723|E2|Reported Event|Warfarin|"Patients receiving Warfarin tablet orally;~1, 3, and 5 mg (dose adjusted to International normalized ratio (INR) target range)"
40904|NCT02348723|E1|Reported Event|Dabigatran Etexilate 150 mg|"Patients receiving Dabigatran Etexilate 150 mg capsule orally twice daily (BID);~1 capsule 150 mg twice daily (total daily dose 300 mg)"
40905|NCT02348658|B1|Baseline|All Participants|All participants who received either 1 of the two treatment sequences: Sequence 1: TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 2 or Sequence 2: TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 2.
40906|NCT02348658|P2|Participant Flow|TAK-536TCH Fed + TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 2.
40907|NCT02348658|P1|Participant Flow|TAK-536TCH Fasted + TAK-536TCH Fed|TAK-536TCH (20 milligram [mg]/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 2.
40908|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
40909|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
40910|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
40911|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
40912|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
40917|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
40918|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
40919|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
40920|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
40921|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
40922|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
40923|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
40924|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
40925|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
40926|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
40927|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
40928|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
40929|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
40930|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
40931|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
40932|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
40933|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
40934|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
40935|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
40936|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
40937|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
40938|NCT02348658|E2|Reported Event|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
40939|NCT02348658|E1|Reported Event|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
40940|NCT02347774|B4|Baseline|Total|Total of all reporting groups
40941|NCT02347774|B3|Baseline|Placebo BID Eflow (CS) Nebulizer|"Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer~Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer"
40942|NCT02347774|B2|Baseline|SUN-101 25 mcg BID e-Flow (CS) Nebulizer|"SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer"
40943|NCT02347774|B1|Baseline|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer"
40944|NCT02347774|P3|Participant Flow|Placebo BID Eflow (CS) Nebulizer|"Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer~Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer"
40945|NCT02347774|P2|Participant Flow|SUN-101 25 mcg BID e-Flow (CS) Nebulizer|"SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer"
40946|NCT02347774|P1|Participant Flow|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer"
40947|NCT02347774|O3|Outcome|Placebo BID Eflow (CS) Nebulizer|"Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer~Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer"
40948|NCT02347774|O2|Outcome|SUN-101 25 mcg BID e-Flow (CS) Nebulizer|"SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer"
40949|NCT02347774|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer"
40950|NCT02347774|O3|Outcome|Placebo BID Eflow (CS) Nebulizer|"Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer~Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer"
40951|NCT02347774|O2|Outcome|SUN-101 25 mcg BID e-Flow (CS) Nebulizer|"SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer"
40952|NCT02347774|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer"
40953|NCT02347774|O3|Outcome|Placebo BID Eflow (CS) Nebulizer|"Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer~Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer"
41101|NCT02347176|B2|Baseline|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
40954|NCT02347774|O2|Outcome|SUN-101 25 mcg BID e-Flow (CS) Nebulizer|"SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer"
40955|NCT02347774|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer"
40956|NCT02347774|O3|Outcome|Placebo BID Eflow (CS) Nebulizer|"Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer~Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer"
40957|NCT02347774|O2|Outcome|SUN-101 25 mcg BID e-Flow (CS) Nebulizer|"SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer"
40958|NCT02347774|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer"
40959|NCT02347774|O3|Outcome|Placebo BID Eflow (CS) Nebulizer|"Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer~Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer"
40960|NCT02347774|O2|Outcome|SUN-101 25 mcg BID e-Flow (CS) Nebulizer|"SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer"
40961|NCT02347774|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer"
40962|NCT02347774|O3|Outcome|Placebo BID Eflow (CS) Nebulizer|"Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer~Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer"
40963|NCT02347774|O2|Outcome|SUN-101 25 mcg BID e-Flow (CS) Nebulizer|"SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer"
40964|NCT02347774|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer"
40965|NCT02347774|O3|Outcome|Placebo BID Eflow (CS) Nebulizer|"Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer~Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer"
40966|NCT02347774|O2|Outcome|SUN-101 25 mcg BID e-Flow (CS) Nebulizer|"SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer"
40967|NCT02347774|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer"
40968|NCT02347774|O3|Outcome|Placebo BID Eflow (CS) Nebulizer|"Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer~Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer"
40969|NCT02347774|O2|Outcome|SUN-101 25 mcg BID e-Flow (CS) Nebulizer|"SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer"
40970|NCT02347774|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer"
40971|NCT02347774|O3|Outcome|Placebo BID Eflow (CS) Nebulizer|"Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer~Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer"
40972|NCT02347774|O2|Outcome|SUN-101 25 mcg BID e-Flow (CS) Nebulizer|"SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer"
40973|NCT02347774|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer"
40974|NCT02347774|O3|Outcome|Placebo BID Eflow (CS) Nebulizer|"Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer~Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer"
40975|NCT02347774|O2|Outcome|SUN-101 25 mcg BID e-Flow (CS) Nebulizer|"SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer"
40976|NCT02347774|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer"
40977|NCT02347774|O3|Outcome|Placebo BID Eflow (CS) Nebulizer|"Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer~Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer"
40978|NCT02347774|O2|Outcome|SUN-101 25 mcg BID e-Flow (CS) Nebulizer|"SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer"
40979|NCT02347774|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer"
40980|NCT02347774|O3|Outcome|Placebo BID Eflow (CS) Nebulizer|"Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer~Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer"
40981|NCT02347774|O2|Outcome|SUN-101 25 mcg BID e-Flow (CS) Nebulizer|"SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer"
40982|NCT02347774|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer"
40983|NCT02347774|O3|Outcome|Placebo BID Eflow (CS) Nebulizer|"Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer~Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer"
41102|NCT02347176|B1|Baseline|Placebo|Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
40984|NCT02347774|O2|Outcome|SUN-101 25 mcg BID e-Flow (CS) Nebulizer|"SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer"
40985|NCT02347774|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer"
40986|NCT02347774|O3|Outcome|Placebo BID Eflow (CS) Nebulizer|"Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer~Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer"
40987|NCT02347774|O2|Outcome|SUN-101 25 mcg BID e-Flow (CS) Nebulizer|"SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer"
40988|NCT02347774|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer"
40989|NCT02347774|O3|Outcome|Placebo BID Eflow (CS) Nebulizer|"Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer~Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer"
40990|NCT02347774|O2|Outcome|SUN-101 25 mcg BID e-Flow (CS) Nebulizer|"SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer"
40991|NCT02347774|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer"
40992|NCT02347774|O3|Outcome|Placebo BID Eflow (CS) Nebulizer|"Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer~Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer"
40993|NCT02347774|O2|Outcome|SUN-101 25 mcg BID e-Flow (CS) Nebulizer|"SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer"
40994|NCT02347774|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer"
40995|NCT02347774|E3|Reported Event|Placebo BID Eflow (CS) Nebulizer|"Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer~Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer"
40996|NCT02347774|E2|Reported Event|SUN-101 25 mcg BID e-Flow (CS) Nebulizer|"SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer"
40997|NCT02347774|E1|Reported Event|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer"
40998|NCT02347761|B4|Baseline|Total|Total of all reporting groups
40999|NCT02347761|B3|Baseline|Placebo BID eFlow (CS) Nebulizer|"Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer~Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer"
41000|NCT02347761|B2|Baseline|SUN-101 25 mcg BID eFlow (CS) Nebulizer|"SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41001|NCT02347761|B1|Baseline|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41002|NCT02347761|P3|Participant Flow|Placebo BID eFlow (CS) Nebulizer|"Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer~Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer"
41003|NCT02347761|P2|Participant Flow|SUN-101 25 mcg BID eFlow (CS) Nebulizer|"SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41004|NCT02347761|P1|Participant Flow|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41005|NCT02347761|O3|Outcome|Placebo BID eFlow (CS) Nebulizer|"Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer~Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer"
41006|NCT02347761|O2|Outcome|SUN-101 25 mcg BID eFlow (CS) Nebulizer|"SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41007|NCT02347761|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41008|NCT02347761|O3|Outcome|Placebo BID eFlow (CS) Nebulizer|"Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer~Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer"
41009|NCT02347761|O2|Outcome|SUN-101 25 mcg BID eFlow (CS) Nebulizer|"SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41010|NCT02347761|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41011|NCT02347761|O3|Outcome|Placebo BID eFlow (CS) Nebulizer|"Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer~Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer"
41012|NCT02347761|O2|Outcome|SUN-101 25 mcg BID eFlow (CS) Nebulizer|"SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41013|NCT02347761|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41014|NCT02347761|O3|Outcome|Placebo BID eFlow (CS) Nebulizer|"Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer~Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer"
41015|NCT02347761|O2|Outcome|SUN-101 25 mcg BID eFlow (CS) Nebulizer|"SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41016|NCT02347761|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41017|NCT02347761|O3|Outcome|Placebo BID eFlow (CS) Nebulizer|"Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer~Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer"
41018|NCT02347761|O2|Outcome|SUN-101 25 mcg BID eFlow (CS) Nebulizer|"SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41019|NCT02347761|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41020|NCT02347761|O3|Outcome|Placebo BID eFlow (CS) Nebulizer|"Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer~Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer"
41021|NCT02347761|O2|Outcome|SUN-101 25 mcg BID eFlow (CS) Nebulizer|"SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41022|NCT02347761|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41023|NCT02347761|O3|Outcome|Placebo BID eFlow (CS) Nebulizer|"Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer~Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer"
41024|NCT02347761|O2|Outcome|SUN-101 25 mcg BID eFlow (CS) Nebulizer|"SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41025|NCT02347761|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41026|NCT02347761|O3|Outcome|Placebo BID eFlow (CS) Nebulizer|"Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer~Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer"
41027|NCT02347761|O2|Outcome|SUN-101 25 mcg BID eFlow (CS) Nebulizer|"SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41028|NCT02347761|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41029|NCT02347761|O3|Outcome|Placebo BID eFlow (CS) Nebulizer|"Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer~Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer"
41030|NCT02347761|O2|Outcome|SUN-101 25 mcg BID eFlow (CS) Nebulizer|"SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41031|NCT02347761|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41032|NCT02347761|O3|Outcome|Placebo BID eFlow (CS) Nebulizer|"Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer~Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer"
41033|NCT02347761|O2|Outcome|SUN-101 25 mcg BID eFlow (CS) Nebulizer|"SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41034|NCT02347761|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41035|NCT02347761|O3|Outcome|Placebo BID eFlow (CS) Nebulizer|"Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer~Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer"
41036|NCT02347761|O2|Outcome|SUN-101 25 mcg BID eFlow (CS) Nebulizer|"SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41037|NCT02347761|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41038|NCT02347761|O3|Outcome|Placebo BID eFlow (CS) Nebulizer|"Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer~Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer"
41039|NCT02347761|O2|Outcome|SUN-101 25 mcg BID eFlow (CS) Nebulizer|"SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41040|NCT02347761|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41041|NCT02347761|O3|Outcome|Placebo BID eFlow (CS) Nebulizer|"Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer~Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer"
41042|NCT02347761|O2|Outcome|SUN-101 25 mcg BID eFlow (CS) Nebulizer|"SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41043|NCT02347761|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41044|NCT02347761|O3|Outcome|Placebo BID eFlow (CS) Nebulizer|"Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer~Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer"
41045|NCT02347761|O2|Outcome|SUN-101 25 mcg BID eFlow (CS) Nebulizer|"SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41046|NCT02347761|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41047|NCT02347761|O3|Outcome|Placebo BID eFlow (CS) Nebulizer|"Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer~Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer"
41048|NCT02347761|O2|Outcome|SUN-101 25 mcg BID eFlow (CS) Nebulizer|"SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41049|NCT02347761|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41050|NCT02347761|O3|Outcome|Placebo BID eFlow (CS) Nebulizer|"Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer~Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer"
41051|NCT02347761|O2|Outcome|SUN-101 25 mcg BID eFlow (CS) Nebulizer|"SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41052|NCT02347761|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41053|NCT02347761|O3|Outcome|Placebo BID eFlow (CS) Nebulizer|"Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer~Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer"
41054|NCT02347761|O2|Outcome|SUN-101 25 mcg BID eFlow (CS) Nebulizer|"SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41055|NCT02347761|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41056|NCT02347761|O3|Outcome|Placebo BID eFlow (CS) Nebulizer|"Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer~Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer"
41057|NCT02347761|O2|Outcome|SUN-101 25 mcg BID eFlow (CS) Nebulizer|"SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41058|NCT02347761|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41059|NCT02347761|E3|Reported Event|Placebo BID eFlow (CS) Nebulizer|"Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer~Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer"
41060|NCT02347761|E2|Reported Event|SUN-101 25 mcg BID eFlow (CS) Nebulizer|"SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41061|NCT02347761|E1|Reported Event|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer"
41062|NCT02347605|B7|Baseline|Total|Total of all reporting groups
41063|NCT02347605|B6|Baseline|Sequence 6|Nicotine lozenge after cue exposure at lab 1; Nicotine lozenge 15 minutes prior to cue exposure at lab 2; Placebo lozenge 15 minute prior to cue exposure at lab 3
41064|NCT02347605|B5|Baseline|Sequence 5|Nicotine lozenge after cue exposure at lab 1; Placebo lozenge 15 minute prior to cue exposure at lab 2; Nicotine lozenge 15 minutes prior to cue exposure at lab 3
41065|NCT02347605|B4|Baseline|Sequence 4|Nicotine lozenge 15 minutes prior to cue exposure at lab 1; Nicotine lozenge after cue exposure at lab 2; Placebo lozenge 15 minute prior to cue exposure at lab 3
41066|NCT02347605|B3|Baseline|Sequence 3|Nicotine lozenge 15 minutes prior to cue exposure at lab 1; Placebo lozenge 15 minute prior to cue exposure at lab 2; Nicotine lozenge after cue exposure at lab 3
41067|NCT02347605|B2|Baseline|Sequence 2|Placebo lozenge 15 minute prior to cue exposure at lab 1; Nicotine lozenge after cue exposure at lab 2; Nicotine lozenge 15 minutes prior to cue exposure at lab 3
41068|NCT02347605|B1|Baseline|Sequence 1|Placebo lozenge 15 minute prior to cue exposure at lab 1; Nicotine lozenge 15 minutes prior to cue exposure at lab 2; Nicotine lozenge after cue exposure at lab 3
41069|NCT02347605|P6|Participant Flow|Sequence 6|Nicotine lozenge after cue exposure at lab 1; Nicotine lozenge 15 minutes prior to cue exposure at lab 2; Placebo lozenge 15 minute prior to cue exposure at lab 3
41070|NCT02347605|P5|Participant Flow|Sequence 5|Nicotine lozenge after cue exposure at lab 1; Placebo lozenge 15 minute prior to cue exposure at lab 2; Nicotine lozenge 15 minutes prior to cue exposure at lab 3
41071|NCT02347605|P4|Participant Flow|Sequence 4|Nicotine lozenge 15 minutes prior to cue exposure at lab 1; Nicotine lozenge after cue exposure at lab 2; Placebo lozenge 15 minute prior to cue exposure at lab 3
41072|NCT02347605|P3|Participant Flow|Sequence 3|Nicotine lozenge 15 minutes prior to cue exposure at lab 1; Placebo lozenge 15 minute prior to cue exposure at lab 2; Nicotine lozenge after cue exposure at lab 3
41073|NCT02347605|P2|Participant Flow|Sequence 2|Placebo lozenge 15 minute prior to cue exposure at lab 1; Nicotine lozenge after cue exposure at lab 2; Nicotine lozenge 15 minutes prior to cue exposure at lab 3
67791|NCT02153489|O2|Outcome|Placebo|Placebo BID
41074|NCT02347605|P1|Participant Flow|Sequence 1|Placebo lozenge 15 minute prior to cue exposure at lab 1; Nicotine lozenge 15 minutes prior to cue exposure at lab 2; Nicotine lozenge after cue exposure at lab 3
41075|NCT02347605|O3|Outcome|Control Condition: Lozenge After Cue Exposure|"Lozenge is used immediately after smoking cue exposure~Nicotine lozenge 4 mg"
41076|NCT02347605|O2|Outcome|Placebo Lozenge Prior to Cue Exposure|"Placebo lozenge is used 15 minutes prior to smoking cue exposure~Placebo lozenge"
41077|NCT02347605|O1|Outcome|Nicotine Lozenge Prior to Cue Exposure|"Nicotine lozenge is used 15 minutes prior to smoking cue exposure~Nicotine lozenge 4 mg"
41078|NCT02347605|O3|Outcome|Control Condition: Lozenge After Cue Exposure|"Lozenge is used immediately after smoking cue exposure~Nicotine lozenge 4 mg"
41079|NCT02347605|O2|Outcome|Placebo Lozenge Prior to Cue Exposure|"Placebo lozenge is used 15 minutes prior to smoking cue exposure~Placebo lozenge"
41080|NCT02347605|O1|Outcome|Nicotine Lozenge Prior to Cue Exposure|"Nicotine lozenge is used 15 minutes prior to smoking cue exposure~Nicotine lozenge 4 mg"
41081|NCT02347605|E3|Reported Event|Control Condition: Lozenge After Cue Exposure|"Lozenge is used immediately after smoking cue exposure~Nicotine lozenge 4 mg"
41082|NCT02347605|E2|Reported Event|Placebo Lozenge Prior to Cue Exposure|"Placebo lozenge is used 15 minutes prior to smoking cue exposure~Placebo lozenge"
41083|NCT02347605|E1|Reported Event|Nicotine Lozenge Prior to Cue Exposure|"Nicotine lozenge is used 15 minutes prior to smoking cue exposure~Nicotine lozenge 4 mg"
41084|NCT02347488|B1|Baseline|Tape, Followed by ETT Holder and Bite Guard|"Tape: Surgery patients had endotracheal tubes secured with adhesive tape, as the current clinical procedure; change in ETT tip position caused by traction up to 15N measured prior to re-securing the ETT with the Haider device.~Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery."
41085|NCT02347488|P1|Participant Flow|Tape, Followed by ETT Holder and Bite Guard|"Tape: Surgery patients had endotracheal tubes secured with adhesive tape, as the current clinical procedure; change in ETT tip position caused by traction up to 15N measured prior to re-securing the ETT with the Haider device.~Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery."
41086|NCT02347488|O2|Outcome|Haider ETT Tube Holder|Following the traction test and measurement of taped ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
41087|NCT02347488|O1|Outcome|Adhesive Tape|Participants had endotracheal tubes secured with tape prior to having surgery, which is the current standard of care. Following the traction test and measurement of ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
41088|NCT02347488|O2|Outcome|Haider ETT Tube Holder|Following the traction test and measurement of taped ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
41089|NCT02347488|O1|Outcome|Adhesive Tape|Participants had endotracheal tubes secured with tape prior to having surgery, which is the current standard of care. Following the traction test and measurement of ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
41090|NCT02347488|O1|Outcome|Tape, Followed by ETT Holder and Bite Guard|"Tape: Surgery patients had endotracheal tubes secured with adhesive tape, as the current clinical procedure; change in ETT tip position caused by traction up to 15N measured prior to re-securing the ETT with the Haider device.~Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery."
41091|NCT02347488|O2|Outcome|Haider ETT Tube Holder|Following the traction test and measurement of taped ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
41092|NCT02347488|O1|Outcome|Adhesive Tape|Participants had endotracheal tubes secured with tape prior to having surgery, which is the current standard of care. Following the traction test and measurement of ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
41093|NCT02347488|E1|Reported Event|Tape, Followed by ETT Holder and Bite Guard|"Tape: Surgery patients had endotracheal tubes secured with adhesive tape, as the current clinical procedure; change in ETT tip position caused by traction up to 15N measured prior to re-securing the ETT with the Haider device.~Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery.~Adverse events were not reported per arm because surgery patients were assessed for adverse events after experiencing both methods."
41094|NCT02347189|B1|Baseline|Melody PB1016 Subjects Consented (i.e. Enrolled)|This study is comprised of a single arm of subjects consented (i.e. enrolled) into the trial. All enrolled subjects were intended to be treated with the Melody TPV PB1016 device. Not all subjects enrolled ultimately received the device.
41095|NCT02347189|P1|Participant Flow|Melody PB1016 Subjects Consented (i.e. Enrolled)|This study is comprised of a single arm of subjects consented (i.e. enrolled) into the trial. All enrolled subjects were intended to be treated with the Melody TPV PB1016 device. Not all subjects enrolled ultimately received the device.
41096|NCT02347189|O1|Outcome|Implanted > 24 Hours Cohort|Subjects included in this analysis were those who were successfully implanted with a Melody TPV PB1016 for greater than 24 hours and had evaluable data at 6 months.
41097|NCT02347189|E1|Reported Event|Melody PB1016 Subjects Consented (i.e. Enrolled)|This study is comprised of a single arm of subjects consented (i.e. enrolled) into the trial. All enrolled subjects were intended to be treated with the Melody TPV PB1016 device. Not all subjects enrolled ultimately received the device.
41098|NCT02347176|B5|Baseline|Total|Total of all reporting groups
41099|NCT02347176|B4|Baseline|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41100|NCT02347176|B3|Baseline|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41937|NCT02340000|O3|Outcome|Standard Dose Time Period 2|amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
41103|NCT02347176|P4|Participant Flow|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41104|NCT02347176|P3|Participant Flow|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41105|NCT02347176|P2|Participant Flow|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41106|NCT02347176|P1|Participant Flow|Placebo|Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41107|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41108|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41109|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41110|NCT02347176|O1|Outcome|Placebo|Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41111|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41112|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41113|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41114|NCT02347176|O1|Outcome|Placebo|Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41115|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41116|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41117|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41118|NCT02347176|O1|Outcome|Placebo|Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41119|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41120|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41121|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41122|NCT02347176|O1|Outcome|Placebo|Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41123|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41124|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41125|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41126|NCT02347176|O1|Outcome|Placebo|Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41127|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41128|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41129|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41130|NCT02347176|O1|Outcome|Placebo|Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41131|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41132|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41133|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41134|NCT02347176|O1|Outcome|Placebo|Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41135|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41136|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41137|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41138|NCT02347176|O1|Outcome|Placebo|Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41139|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41140|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41141|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41142|NCT02347176|O1|Outcome|Placebo|Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41143|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41144|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41145|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41146|NCT02347176|O1|Outcome|Placebo|Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41147|NCT02347176|E4|Reported Event|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41148|NCT02347176|E3|Reported Event|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41149|NCT02347176|E2|Reported Event|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41150|NCT02347176|E1|Reported Event|Placebo|Placebo matched to Tralokinumab was administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
41151|NCT02347124|B3|Baseline|Total|Total of all reporting groups
41152|NCT02347124|B2|Baseline|Enhanced Intervention|"Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .~Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)"
41153|NCT02347124|B1|Baseline|Usual Care Control|"Standard tobacco quitline counseling program and materials + attention-matched text messaging.~Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips."
41154|NCT02347124|P2|Participant Flow|Enhanced Intervention|"Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .~Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)"
41155|NCT02347124|P1|Participant Flow|Usual Care Control|"Standard tobacco quitline counseling program and materials + attention-matched text messaging.~Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips."
41156|NCT02347124|O2|Outcome|Enhanced Intervention|"Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .~Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)"
41157|NCT02347124|O1|Outcome|Usual Care Control|"Standard tobacco quitline counseling program and materials + attention-matched text messaging.~Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips."
41158|NCT02347124|O2|Outcome|Enhanced Intervention|"Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .~Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)"
41159|NCT02347124|O1|Outcome|Usual Care Control|"Standard tobacco quitline counseling program and materials + attention-matched text messaging.~Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips."
41160|NCT02347124|O2|Outcome|Enhanced Intervention|"Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .~Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)"
41161|NCT02347124|O1|Outcome|Usual Care Control|"Standard tobacco quitline counseling program and materials + attention-matched text messaging.~Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips."
41162|NCT02347124|O2|Outcome|Enhanced Intervention|"Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .~Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)"
41163|NCT02347124|O1|Outcome|Usual Care Control|"Standard tobacco quitline counseling program and materials + attention-matched text messaging.~Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips."
41164|NCT02347124|O2|Outcome|Enhanced Intervention|"Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .~Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)"
41165|NCT02347124|O1|Outcome|Usual Care Control|"Standard tobacco quitline counseling program and materials + attention-matched text messaging.~Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips."
41166|NCT02347124|O2|Outcome|Enhanced Intervention|"Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .~Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)"
41804|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
41167|NCT02347124|O1|Outcome|Usual Care Control|"Standard tobacco quitline counseling program and materials + attention-matched text messaging.~Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips."
41168|NCT02347124|O2|Outcome|Enhanced Intervention|"Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .~Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)"
41169|NCT02347124|O1|Outcome|Usual Care Control|"Standard tobacco quitline counseling program and materials + attention-matched text messaging.~Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips."
41170|NCT02347124|O2|Outcome|Enhanced Intervention|"Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .~Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)"
41171|NCT02347124|O1|Outcome|Usual Care Control|"Standard tobacco quitline counseling program and materials + attention-matched text messaging.~Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips."
41172|NCT02347124|O2|Outcome|Enhanced Intervention|"Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .~Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)"
41173|NCT02347124|O1|Outcome|Usual Care Control|"Standard tobacco quitline counseling program and materials + attention-matched text messaging.~Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips."
41174|NCT02347124|O2|Outcome|Enhanced Intervention|"Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .~Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)"
41175|NCT02347124|O1|Outcome|Usual Care Control|"Standard tobacco quitline counseling program and materials + attention-matched text messaging.~Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips."
41176|NCT02347124|O2|Outcome|Enhanced Intervention|"Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .~Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)"
41177|NCT02347124|O1|Outcome|Usual Care Control|"Standard tobacco quitline counseling program and materials + attention-matched text messaging.~Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips."
41178|NCT02347124|O2|Outcome|Enhanced Intervention|"Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .~Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)"
41179|NCT02347124|O1|Outcome|Usual Care Control|"Standard tobacco quitline counseling program and materials + attention-matched text messaging.~Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips."
41180|NCT02347124|O2|Outcome|Enhanced Intervention|"Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .~Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)"
41181|NCT02347124|O1|Outcome|Usual Care Control|"Standard tobacco quitline counseling program and materials + attention-matched text messaging.~Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips."
41182|NCT02347124|O2|Outcome|Enhanced Intervention|"Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .~Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)"
41183|NCT02347124|O1|Outcome|Usual Care Control|"Standard tobacco quitline counseling program and materials + attention-matched text messaging.~Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips."
41184|NCT02347124|O2|Outcome|Enhanced Intervention|"Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .~Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)"
41185|NCT02347124|O1|Outcome|Usual Care Control|"Standard tobacco quitline counseling program and materials + attention-matched text messaging.~Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips."
41186|NCT02347124|E2|Reported Event|Enhanced Intervention|"Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .~Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)"
41187|NCT02347124|E1|Reported Event|Usual Care Control|"Standard tobacco quitline counseling program and materials + attention-matched text messaging.~Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips."
41188|NCT02347085|B1|Baseline|All Subjects|
41189|NCT02347085|P1|Participant Flow|Overall Study|All subjects randomized
41190|NCT02347085|O2|Outcome|Placebo|Placebo MDI
41191|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
41192|NCT02347085|O2|Outcome|Placebo|Placebo MDI
41193|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
41194|NCT02347085|O2|Outcome|Placebo|Placebo MDI
41195|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
41196|NCT02347085|O2|Outcome|Placebo|Placebo MDI
41197|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
41198|NCT02347085|O2|Outcome|Placebo|Placebo MDI
41199|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
41200|NCT02347085|O2|Outcome|Placebo|Placebo MDI
41201|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
41202|NCT02347085|O2|Outcome|Placebo|Placebo MDI
41203|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
41204|NCT02347085|O2|Outcome|Placebo|Placebo MDI
41205|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
41206|NCT02347085|O2|Outcome|Placebo|Placebo MDI
41207|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
41208|NCT02347085|E2|Reported Event|Placebo|Placebo MDI
41209|NCT02347085|E1|Reported Event|GFF MDI PT003|GFF MDI 14.4/9.6 µg
41210|NCT02347072|B1|Baseline|All Subjects|
41211|NCT02347072|P1|Participant Flow|Overall Study|All Subjects Randomized
41212|NCT02347072|O3|Outcome|Placebo|Placebo MDI
41213|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
41214|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
41215|NCT02347072|O3|Outcome|Placebo|Placebo MDI
41216|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
41217|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
41218|NCT02347072|O3|Outcome|Placebo|Placebo MDI
41219|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
41220|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
41221|NCT02347072|O3|Outcome|Placebo|Placebo MDI
41222|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
41223|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
41224|NCT02347072|O3|Outcome|Placebo|Placebo MDI
41225|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
41226|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
41227|NCT02347072|O3|Outcome|Placebo|Placebo MDI
41228|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
41229|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
41230|NCT02347072|O3|Outcome|Placebo|Placebo MDI
41231|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
41232|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
41233|NCT02347072|O3|Outcome|Placebo|Placebo MDI
41234|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
41235|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
41236|NCT02347072|O3|Outcome|Placebo|Placebo MDI
41237|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
41238|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
41239|NCT02347072|E3|Reported Event|Placebo|Placebo MDI
41240|NCT02347072|E2|Reported Event|Spiriva Respimat|Spiriva Respimat 5μg
41241|NCT02347072|E1|Reported Event|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
41242|NCT02346877|B3|Baseline|Total|Total of all reporting groups
41243|NCT02346877|B2|Baseline|Personalized Patient Counselling (Interventional) Cohort|Participants enrolled in the interventional cohort were to receive Enbrel® (etanercept) therapy and personalized patient counselling using the Information-Motivation-Strategy (IMS) model based on Beliefs about Medicines Questionnaire (BMQ) results through a patient assistance program for patients on Enbrel (etanercept) therapy.
41244|NCT02346877|B1|Baseline|Standard of Care (Control) Cohort|The first 100 participants were to be enrolled in the standard of care cohort. These participants received treatment with Enbrel® (etanercept) in routine clinical practice and were to complete a 52 week study period as per the investigator's standard of care.
41245|NCT02346877|P2|Participant Flow|Personalized Patient Counselling (Interventional) Cohort|Participants enrolled in the interventional cohort were to receive Enbrel® (etanercept) therapy and personalized patient counselling using the Information-Motivation-Strategy (IMS) model based on Beliefs about Medicines Questionnaire (BMQ) results through a patient assistance program for patients on Enbrel (etanercept) therapy.
41290|NCT02345330|B1|Baseline|Tavokinogene Telseplasmid (Tavo) Electroporation (EP)|Participants received tavo intratumorally followed immediately by electroporation (EP) on Days 1, 8, and 15 in a 6-week cycle for up to 9 cycles.
41246|NCT02346877|P1|Participant Flow|Standard of Care (Control) Cohort|The first 100 participants were to be enrolled in the standard of care cohort. These participants received treatment with Enbrel® (etanercept) in routine clinical practice and were to complete a 52 week study period as per the investigator's standard of care.
41247|NCT02346877|O2|Outcome|Personalized Patient Counselling (Interventional) Cohort|Participants enrolled in the interventional cohort were to receive Enbrel® (etanercept) therapy and personalized patient counselling using the Information-Motivation-Strategy (IMS) model based on Beliefs about Medicines Questionnaire (BMQ) results through a patient assistance program for patients on Enbrel (etanercept) therapy.
41248|NCT02346877|O1|Outcome|Standard of Care (Control) Cohort|The first 100 participants were to be enrolled in the standard of care cohort. These participants received treatment with Enbrel® (etanercept) in routine clinical practice and were to complete a 52 week study period as per the investigator's standard of care.
41249|NCT02346877|O2|Outcome|Personalized Patient Counselling (Interventional) Cohort|Participants enrolled in the interventional cohort were to receive Enbrel® (etanercept) therapy and personalized patient counselling using the Information-Motivation-Strategy (IMS) model based on Beliefs about Medicines Questionnaire (BMQ) results through a patient assistance program for patients on Enbrel (etanercept) therapy.
41250|NCT02346877|O1|Outcome|Standard of Care (Control) Cohort|The first 100 participants were to be enrolled in the standard of care cohort. These participants received treatment with Enbrel® (etanercept) in routine clinical practice and were to complete a 52 week study period as per the investigator's standard of care.
41251|NCT02346877|O2|Outcome|Personalized Patient Counselling (Interventional) Cohort|Participants enrolled in the interventional cohort were to receive Enbrel® (etanercept) therapy and personalized patient counselling using the Information-Motivation-Strategy (IMS) model based on Beliefs about Medicines Questionnaire (BMQ) results through a patient assistance program for patients on Enbrel (etanercept) therapy.
41252|NCT02346877|O1|Outcome|Standard of Care (Control) Cohort|The first 100 participants were to be enrolled in the standard of care cohort. These participants received treatment with Enbrel® (etanercept) in routine clinical practice and were to complete a 52 week study period as per the investigator's standard of care.
41253|NCT02346877|E2|Reported Event|Personalized Patient Counselling (Interventional) Cohort|Participants enrolled in the interventional cohort were to receive Enbrel® (etanercept) therapy and personalized patient counselling using the Information-Motivation-Strategy (IMS) model based on Beliefs about Medicines Questionnaire (BMQ) results through a patient assistance program for patients on Enbrel (etanercept) therapy.
41254|NCT02346877|E1|Reported Event|Standard of Care (Control) Cohort|The first 100 participants were to be enrolled in the standard of care cohort. These participants received treatment with Enbrel® (etanercept) in routine clinical practice and were to complete a 52 week study period as per the investigator's standard of care.
41255|NCT02346721|B1|Baseline|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily
41256|NCT02346721|P1|Participant Flow|SOF/VEL 12 Weeks|Sofosbuvir/velpatasvir (SOF/VEL; Epclusa®) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily
41257|NCT02346721|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily
41258|NCT02346721|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily
41259|NCT02346721|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL 400/100 mg fixed-dose combination (FDC) tablet orally once daily
41260|NCT02346721|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily
41261|NCT02346721|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily
41262|NCT02346721|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL 400/100 mg FDC tablet orally once daily
41263|NCT02346721|E1|Reported Event|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily
41264|NCT02346643|B1|Baseline|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
41265|NCT02346643|P1|Participant Flow|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
41266|NCT02346643|O1|Outcome|Subjected Treated With the Permanent|All subjects treated with the Axium implantable neurostimulator
41267|NCT02346643|O1|Outcome|Subjected Treated With the Permanent|All subjects treated with the Axium implantable neurostimulator
41268|NCT02346643|E1|Reported Event|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
41269|NCT02345772|B1|Baseline|Treatment Protocol|Hormonal therapy with fulvestrant 500 mg will be administered intramuscularly on days 1, 15 of the first cycle, and thereafter on day 1 of every 28-day cycle for up to 5 cycles before surgery. Docetaxel (T) 75 mg/m2 every 3 weeks will be given for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery.
41270|NCT02345772|P1|Participant Flow|Treatment Protocol|"Hormonal therapy with fulvestrant 500 mg will be administered intramuscularly on days 1, 15 of the first cycle, and thereafter on day 1 of every 28-day cycle for up to 5 cycles before surgery. Docetaxel (T) 75 mg/m2 every 3 weeks will be given for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery.~fulvestrant 500 mg: Hormonal therapy with fulvestrant 500 mg will be administered intramuscularly on days 1, 15 of the first cycle, and thereafter on day 1 of every 28-day cycle for up to 5 cycles before surgery.~Docetaxel (T) 75 mg/m2 (Taxotere): Docetaxel (T) 75 mg/m2 every 3 weeks will be given for four cycles.~Trastuzumab (H, 8mg/kg: Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle,"
41291|NCT02345330|P1|Participant Flow|Tavokinogene Telseplasmid (Tavo) Electroporation (EP)|Participants received tavo intratumorally followed immediately by electroporation (EP) on Days 1, 8, and 15 in a 6-week cycle for up to 9 cycles.
41292|NCT02345330|O1|Outcome|Tavokinogene Telseplasmid (Tavo) Electroporation (EP)|Participants received tavo intratumorally followed immediately by electroporation (EP) on Days 1, 8, and 15 in a 6-week cycle for up to 9 cycles.
41293|NCT02345330|O1|Outcome|Tavokinogene Telseplasmid (Tavo) Electroporation (EP)|Participants received tavo intratumorally followed immediately by electroporation (EP) on Days 1, 8, and 15 in a 6-week cycle for up to 9 cycles.
41271|NCT02345772|O1|Outcome|Treatment Protocol|"Hormonal therapy with fulvestrant 500 mg will be administered intramuscularly on days 1, 15 of the first cycle, and thereafter on day 1 of every 28-day cycle for up to 5 cycles before surgery. Docetaxel (T) 75 mg/m2 every 3 weeks will be given for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery.~fulvestrant 500 mg: Hormonal therapy with fulvestrant 500 mg will be administered intramuscularly on days 1, 15 of the first cycle, and thereafter on day 1 of every 28-day cycle for up to 5 cycles before surgery.~Docetaxel (T) 75 mg/m2 (Taxotere): Docetaxel (T) 75 mg/m2 every 3 weeks will be given for four cycles.~Trastuzumab (H, 8mg/kg: Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle,"
41272|NCT02345772|O1|Outcome|Treatment Protocol|"Hormonal therapy with fulvestrant 500 mg will be administered intramuscularly on days 1, 15 of the first cycle, and thereafter on day 1 of every 28-day cycle for up to 5 cycles before surgery. Docetaxel (T) 75 mg/m2 every 3 weeks will be given for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery.~fulvestrant 500 mg: Hormonal therapy with fulvestrant 500 mg will be administered intramuscularly on days 1, 15 of the first cycle, and thereafter on day 1 of every 28-day cycle for up to 5 cycles before surgery.~Docetaxel (T) 75 mg/m2 (Taxotere): Docetaxel (T) 75 mg/m2 every 3 weeks will be given for four cycles.~Trastuzumab (H, 8mg/kg: Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle,"
41273|NCT02345772|O1|Outcome|Treatment Protocol|"Hormonal therapy with fulvestrant 500 mg will be administered intramuscularly on days 1, 15 of the first cycle, and thereafter on day 1 of every 28-day cycle for up to 5 cycles before surgery. Docetaxel (T) 75 mg/m2 every 3 weeks will be given for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery.~fulvestrant 500 mg: Hormonal therapy with fulvestrant 500 mg will be administered intramuscularly on days 1, 15 of the first cycle, and thereafter on day 1 of every 28-day cycle for up to 5 cycles before surgery.~Docetaxel (T) 75 mg/m2 (Taxotere): Docetaxel (T) 75 mg/m2 every 3 weeks will be given for four cycles.~Trastuzumab (H, 8mg/kg: Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle,"
41274|NCT02345772|E1|Reported Event|Treatment Protocol|Hormonal therapy with fulvestrant 500 mg will be administered intramuscularly on days 1, 15 of the first cycle, and thereafter on day 1 of every 28-day cycle for up to 5 cycles before surgery. Docetaxel (T) 75 mg/m2 every 3 weeks will be given for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery.
41275|NCT02345720|B1|Baseline|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
41276|NCT02345720|P1|Participant Flow|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
41277|NCT02345720|O1|Outcome|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
41278|NCT02345720|O1|Outcome|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
41279|NCT02345720|O1|Outcome|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
41280|NCT02345720|E1|Reported Event|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
41281|NCT02345642|B3|Baseline|Total|Total of all reporting groups
41282|NCT02345642|B2|Baseline|10 Patients With THA on Post-Op Day 2|"The 10 test subjects of this study arm will be primary THR patients of Dr. Westrich that have undergone uncomplicated THR surgery in which they are allowed to be full weight bearing by or before post-op day 2.~ActiveCare+SFT Supine~VenaFlow Elite Supine~ActiveCare+SFT Standing~VenaFlow Elite Standing"
41283|NCT02345642|B1|Baseline|10 Healthy Patients Without THA|"The 10 test subjects of this study arm will be healthy volunteers of various ages that are willing to have the efficacy of pneumatic compression tested on them.~ActiveCare+SFT Supine~VenaFlow Elite Supine~ActiveCare+SFT Standing~VenaFlow Elite Standing"
41284|NCT02345642|P2|Participant Flow|10 Patients With THA on Post-Op Day 2|"The 10 test subjects of this study arm will be primary THR patients of Dr. Westrich that have undergone uncomplicated THR surgery in which they are allowed to be full weight bearing by or before post-op day 2.~ActiveCare+SFT Supine~VenaFlow Elite Supine~ActiveCare+SFT Standing~VenaFlow Elite Standing"
41285|NCT02345642|P1|Participant Flow|10 Healthy Patients Without THA|"The 10 test subjects of this study arm will be healthy volunteers of various ages that are willing to have the efficacy of pneumatic compression tested on them. A randomization technique was used to determine laterality and sequence of study events.~ActiveCare+SFT Supine~VenaFlow Elite Supine~ActiveCare+SFT Standing~VenaFlow Elite Standing"
41286|NCT02345642|O2|Outcome|10 Patients With THA on Post-Op Day 2|"The 10 test subjects of this study arm will be primary THR patients of Dr. Westrich that have undergone uncomplicated THR surgery in which they are allowed to be full weight bearing by or before post-op day 2.~ActiveCare+SFT Supine~VenaFlow Elite Supine~ActiveCare+SFT Standing~VenaFlow Elite Standing"
41287|NCT02345642|O1|Outcome|10 Healthy Patients Without THA|"The 10 test subjects of this study arm will be healthy volunteers of various ages that are willing to have the efficacy of pneumatic compression tested on them.~ActiveCare+SFT Supine~VenaFlow Elite Supine~ActiveCare+SFT Standing~VenaFlow Elite Standing"
41288|NCT02345642|E2|Reported Event|10 Patients With THA on Post-Op Day 2|"The 10 test subjects of this study arm will be primary THR patients of Dr. Westrich that have undergone uncomplicated THR surgery in which they are allowed to be full weight bearing by or before post-op day 2.~ActiveCare+SFT Supine~VenaFlow Elite Supine~ActiveCare+SFT Standing~VenaFlow Elite Standing"
41289|NCT02345642|E1|Reported Event|10 Healthy Patients Without THA|"The 10 test subjects of this study arm will be healthy volunteers of various ages that are willing to have the efficacy of pneumatic compression tested on them.~ActiveCare+SFT Supine~VenaFlow Elite Supine~ActiveCare+SFT Standing~VenaFlow Elite Standing"
41351|NCT02344745|B3|Baseline|Total|Total of all reporting groups
41294|NCT02345330|O1|Outcome|Tavokinogene Telseplasmid (Tavo) Electroporation (EP)|Participants received tavo intratumorally followed immediately by electroporation (EP) on Days 1, 8, and 15 in a 6-week cycle for up to 9 cycles.
41295|NCT02345330|O1|Outcome|Tavokinogene Telseplasmid (Tavo) Electroporation (EP)|Participants received tavo intratumorally followed immediately by electroporation (EP) on Days 1, 8, and 15 in a 6-week cycle for up to 9 cycles.
41296|NCT02345330|O1|Outcome|Tavokinogene Telseplasmid (Tavo) Electroporation (EP)|Participants received tavo intratumorally followed immediately by electroporation (EP) on Days 1, 8, and 15 in a 6-week cycle for up to 9 cycles.
41297|NCT02345330|O1|Outcome|Tavokinogene Telseplasmid (Tavo) Electroporation (EP)|Participants received tavo intratumorally followed immediately by electroporation (EP) on Days 1, 8, and 15 in a 6-week cycle for up to 9 cycles.
41298|NCT02345330|O1|Outcome|Tavokinogene Telseplasmid (Tavo) Electroporation (EP)|Participants received tavo intratumorally followed immediately by electroporation (EP) on Days 1, 8, and 15 in a 6-week cycle for up to 9 cycles.
41299|NCT02345330|E1|Reported Event|Tavokinogene Telseplasmid (Tavo) Electroporation (EP)|Participants received tavo intratumorally followed immediately by electroporation (EP) on Days 1, 8, and 15 in a 6-week cycle for up to 9 cycles.
41300|NCT02345252|B3|Baseline|Total|Total of all reporting groups
41301|NCT02345252|B2|Baseline|FTC/RPV/TDF|FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41302|NCT02345252|B1|Baseline|FTC/RPV/TAF|FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41303|NCT02345252|P2|Participant Flow|FTC/RPV/TDF|FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41304|NCT02345252|P1|Participant Flow|FTC/RPV/TAF|Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey® (ODE); FTC/RPV/TAF) (200/25/25 mg) fixed-dose combination (FDC) tablet + emtricitabine/rilpivirine/tenofovir disoproxil fumarate (Complera®(CPA)/Eviplera®; FTC/RPV/TDF) placebo tablet orally once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41305|NCT02345252|O2|Outcome|FTC/RPV/TDF|FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41306|NCT02345252|O1|Outcome|FTC/RPV/TAF|FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41307|NCT02345252|O2|Outcome|FTC/RPV/TDF|FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41308|NCT02345252|O1|Outcome|FTC/RPV/TAF|FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41309|NCT02345252|O2|Outcome|FTC/RPV/TDF|FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41310|NCT02345252|O1|Outcome|FTC/RPV/TAF|FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41311|NCT02345252|O2|Outcome|FTC/RPV/TDF|FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41312|NCT02345252|O1|Outcome|FTC/RPV/TAF|FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41313|NCT02345252|O2|Outcome|FTC/RPV/TDF|FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41314|NCT02345252|O1|Outcome|FTC/RPV/TAF|FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41315|NCT02345252|E2|Reported Event|FTC/RPV/TDF|FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41316|NCT02345252|E1|Reported Event|FTC/RPV/TAF|FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41317|NCT02345226|B3|Baseline|Total|Total of all reporting groups
41318|NCT02345226|B2|Baseline|EFV/FTC/TDF|EFV/FTC/TDF (600/200/300 mg) FDC tablet orally, on an empty stomach, once daily at bedtime + FTC/RPV/TAF placebo tablet orally, with food, once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41319|NCT02345226|B1|Baseline|FTC/RPV/TAF|FTC/RPV/TAF (200/25/25 mg) FDC tablet orally, with food once daily + EFV/FTC/TDF placebo tablet orally, on an empty stomach once daily at bedtime for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41320|NCT02345226|P2|Participant Flow|EFV/FTC/TDF|EFV/FTC/TDF (600/200/300 mg) FDC tablet orally, on an empty stomach, once daily at bedtime + FTC/RPV/TAF placebo tablet orally, with food, once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41321|NCT02345226|P1|Participant Flow|FTC/RPV/TAF|Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey®; FTC/RPV/TAF) (200/25/25 mg) fixed-dose combination (FDC) tablet orally, with food once daily + efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla®; EFV/FTC/TDF) placebo tablet orally, on an empty stomach once daily at bedtime for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41322|NCT02345226|O2|Outcome|EFV/FTC/TDF|EFV/FTC/TDF (600/200/300 mg) FDC tablet orally, on an empty stomach, once daily at bedtime + FTC/RPV/TAF placebo tablet orally, with food, once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41323|NCT02345226|O1|Outcome|FTC/RPV/TAF|FTC/RPV/TAF (200/25/25 mg) FDC tablet orally, with food once daily + EFV/FTC/TDF placebo tablet orally, on an empty stomach once daily at bedtime for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41324|NCT02345226|O2|Outcome|EFV/FTC/TDF|EFV/FTC/TDF (600/200/300 mg) FDC tablet orally, on an empty stomach, once daily at bedtime + FTC/RPV/TAF placebo tablet orally, with food, once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41325|NCT02345226|O1|Outcome|FTC/RPV/TAF|FTC/RPV/TAF (200/25/25 mg) FDC tablet orally, with food once daily + EFV/FTC/TDF placebo tablet orally, on an empty stomach once daily at bedtime for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41326|NCT02345226|O2|Outcome|EFV/FTC/TDF|EFV/FTC/TDF (600/200/300 mg) FDC tablet orally, on an empty stomach, once daily at bedtime + FTC/RPV/TAF placebo tablet orally, with food, once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41327|NCT02345226|O1|Outcome|FTC/RPV/TAF|FTC/RPV/TAF (200/25/25 mg) FDC tablet orally, with food once daily + EFV/FTC/TDF placebo tablet orally, on an empty stomach once daily at bedtime for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41328|NCT02345226|O2|Outcome|EFV/FTC/TDF|EFV/FTC/TDF (600/200/300 mg) FDC tablet orally, on an empty stomach, once daily at bedtime + FTC/RPV/TAF placebo tablet orally, with food, once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41329|NCT02345226|O1|Outcome|FTC/RPV/TAF|FTC/RPV/TAF (200/25/25 mg) FDC tablet orally, with food once daily + EFV/FTC/TDF placebo tablet orally, on an empty stomach once daily at bedtime for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41330|NCT02345226|O2|Outcome|EFV/FTC/TDF|EFV/FTC/TDF (600/200/300 mg) FDC tablet orally, on an empty stomach, once daily at bedtime + FTC/RPV/TAF placebo tablet orally, with food, once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41331|NCT02345226|O1|Outcome|FTC/RPV/TAF|FTC/RPV/TAF (200/25/25 mg) FDC tablet orally, with food once daily + EFV/FTC/TDF placebo tablet orally, on an empty stomach once daily at bedtime for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41332|NCT02345226|O2|Outcome|EFV/FTC/TDF|EFV/FTC/TDF (600/200/300 mg) FDC tablet orally, on an empty stomach, once daily at bedtime + FTC/RPV/TAF placebo tablet orally, with food, once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41333|NCT02345226|O1|Outcome|FTC/RPV/TAF|FTC/RPV/TAF (200/25/25 mg) FDC tablet orally, with food once daily + EFV/FTC/TDF placebo tablet orally, on an empty stomach once daily at bedtime for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41334|NCT02345226|E2|Reported Event|EFV/FTC/TDF|EFV/FTC/TDF (600/200/300 mg) FDC tablet orally, on an empty stomach, once daily at bedtime + FTC/RPV/TAF placebo tablet orally, with food, once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41335|NCT02345226|E1|Reported Event|FTC/RPV/TAF|FTC/RPV/TAF (200/25/25 mg) FDC tablet orally, with food once daily + EFV/FTC/TDF placebo tablet orally, on an empty stomach once daily at bedtime for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
41336|NCT02345031|B3|Baseline|Total|Total of all reporting groups
41337|NCT02345031|B2|Baseline|(AUT00063 Placebo Capsules)|"3 capsules of placebo, to take orally once daily with food for 4 weeks~Placebo: orally, once a day, for 4 weeks"
41338|NCT02345031|B1|Baseline|AUT00063 (600 mg Capsules)|"3 capsules of 200 mg of the investigational drug AUT00063, to take orally once daily with food for 4 weeks~AUT00063: 600 mg, orally, once a day, for 4 weeks"
41339|NCT02345031|P2|Participant Flow|(AUT00063 Placebo Capsules)|"3 capsules of placebo, to take orally once daily with food for 4 weeks~Placebo: orally, once a day, for 4 weeks"
41340|NCT02345031|P1|Participant Flow|AUT00063 (600 mg Capsules)|"3 capsules of 200 mg of the investigational drug AUT00063, to take orally once daily with food for 4 weeks~AUT00063: 600 mg, orally, once a day, for 4 weeks"
41341|NCT02345031|O2|Outcome|Placebo|"3 capsules of placebo, to take orally once daily with food for 4 weeks~Placebo: orally, once a day, for 4 weeks"
41342|NCT02345031|O1|Outcome|AUT00063 (600 mg Capsules)|"3 capsules of 200 mg of the investigational drug AUT00063, to take orally once daily with food for 4 weeks~AUT00063: 600 mg, orally, once a day, for 4 weeks"
41343|NCT02345031|O2|Outcome|(AUT00063 Placebo Capsules)|"3 capsules of placebo, to take orally once daily with food for 4 weeks~Placebo: orally, once a day, for 4 weeks"
41344|NCT02345031|O1|Outcome|AUT00063 (600 mg Capsules)|"3 capsules of 200 mg of the investigational drug AUT00063, to take orally once daily with food for 4 weeks~AUT00063: 600 mg, orally, once a day, for 4 weeks"
41345|NCT02345031|O2|Outcome|(AUT00063 Placebo Capsules)|"3 capsules of placebo, to take orally once daily with food for 4 weeks~Placebo: orally, once a day, for 4 weeks"
41346|NCT02345031|O1|Outcome|AUT00063 (600 mg Capsules)|"3 capsules of 200 mg of the investigational drug AUT00063, to take orally once daily with food for 4 weeks~AUT00063: 600 mg, orally, once a day, for 4 weeks"
41347|NCT02345031|O2|Outcome|(AUT00063 Placebo Capsules)|"3 capsules of placebo, to take orally once daily with food for 4 weeks~Placebo: orally, once a day, for 4 weeks"
41348|NCT02345031|O1|Outcome|AUT00063 (600 mg Capsules)|"3 capsules of 200 mg of the investigational drug AUT00063, to take orally once daily with food for 4 weeks~AUT00063: 600 mg, orally, once a day, for 4 weeks"
41349|NCT02345031|E2|Reported Event|Placebo (AUT00063 Placebo Capsules)|"3 capsules of placebo, to take orally once daily with food for 4 weeks~Placebo: orally, once a day, for 4 weeks"
41350|NCT02345031|E1|Reported Event|AUT00063 (600 mg Capsules)|"3 capsules of 200 mg of the investigational drug AUT00063, to take orally once daily with food for 4 weeks~AUT00063: 600 mg, orally, once a day, for 4 weeks"
41352|NCT02344745|B2|Baseline|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)~Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
41353|NCT02344745|B1|Baseline|Control|"Distilled water~Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
41354|NCT02344745|P2|Participant Flow|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)~Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
41355|NCT02344745|P1|Participant Flow|Control|"Distilled water~Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
41356|NCT02344745|O2|Outcome|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)~Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
41357|NCT02344745|O1|Outcome|Control|"Distilled water~Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
41358|NCT02344745|O2|Outcome|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)~Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
41359|NCT02344745|O1|Outcome|Control|"Distilled water~Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
41360|NCT02344745|O2|Outcome|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)~Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
41361|NCT02344745|O1|Outcome|Control|"Distilled water~Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
41362|NCT02344745|O2|Outcome|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)~Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
41363|NCT02344745|O1|Outcome|Control|"Distilled water~Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
41364|NCT02344745|E2|Reported Event|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)~Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
41365|NCT02344745|E1|Reported Event|Control|"Distilled water~Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
41366|NCT02344407|B4|Baseline|Total|Total of all reporting groups
41367|NCT02344407|B3|Baseline|Placebo (Saline)|Placebo
41368|NCT02344407|B2|Baseline|VSVG-ZEBOV|"VSVG-ZEBOV~VSVG-ZEBOV: The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV)"
41369|NCT02344407|B1|Baseline|ChAd3-EBO Z|"ChAd3-EBO Z~ChAd3-EBO Z: The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion."
41370|NCT02344407|P3|Participant Flow|Placebo (Saline)|Placebo
41371|NCT02344407|P2|Participant Flow|VSVG-ZEBOV|"VSVG-ZEBOV~VSVG-ZEBOV: The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV)"
41372|NCT02344407|P1|Participant Flow|ChAd3-EBO Z|"ChAd3-EBO Z~ChAd3-EBO Z: The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion."
41373|NCT02344407|O3|Outcome|Placebo (Saline)|Placebo
41374|NCT02344407|O2|Outcome|VSVG-ZEBOV|"VSVG-ZEBOV~VSVG-ZEBOV: The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV)"
41540|NCT02342561|O2|Outcome|Control Knee (No-drape Knees)|The knee that is not drape is left uncovered during the intervention.
42053|NCT02338843|E1|Reported Event|LJPC-501 (Angiotensin II)|"Treatment arm~LJPC-501: Treatment arm"
41375|NCT02344407|O1|Outcome|ChAd3-EBO Z|"ChAd3-EBO Z~ChAd3-EBO Z: The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion."
41376|NCT02344407|O3|Outcome|Placebo (Saline)|Placebo
41377|NCT02344407|O2|Outcome|VSVG-ZEBOV|"VSVG-ZEBOV~VSVG-ZEBOV: The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV)"
41378|NCT02344407|O1|Outcome|ChAd3-EBO Z|"ChAd3-EBO Z~ChAd3-EBO Z: The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion."
41379|NCT02344407|E3|Reported Event|Placebo (Saline)|Placebo
41380|NCT02344407|E2|Reported Event|VSVG-ZEBOV|"VSVG-ZEBOV~VSVG-ZEBOV: The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV)"
41381|NCT02344407|E1|Reported Event|ChAd3-EBO Z|"ChAd3-EBO Z~ChAd3-EBO Z: The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion."
41382|NCT02344342|B5|Baseline|Total|Total of all reporting groups
41383|NCT02344342|B4|Baseline|Health Buddy No and Flexible Diuretic No|"Telemonitoring: No~Flexible Diuretic No"
41384|NCT02344342|B3|Baseline|Health Buddy No and Flexible Diuretic Yes|"Telemonitoring: No~Flexible Diuretic Yes"
41385|NCT02344342|B2|Baseline|Health Buddy Yes and Flexible Diuretic No|"Telemonitoring: Yes~Flexible Diuretic No"
41386|NCT02344342|B1|Baseline|Health Buddy Yes and Flexible Diuretic Yes|"Telemonitoring: Yes~Flexible Diuretic Yes"
41387|NCT02344342|P4|Participant Flow|Health Buddy No and Flexible Diuretic No|"Telemonitoring: These patients will not be assigned to the Health Buddy Web intervention.~Flexible Diuretic Regimen: These patients will not be assigned to follow a flexible diuretic regimen."
41388|NCT02344342|P3|Participant Flow|Health Buddy No and Flexible Diuretic Yes|"Telemonitoring: These patients will not receive care with the Health Buddy Web intervention.~Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges."
41389|NCT02344342|P2|Participant Flow|Health Buddy Yes and Flexible Diuretic Regimen No|"Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.~Flexible Diuretic Regimen: These patients will not be assigned to receive a flexible diuretic prescription"
41390|NCT02344342|P1|Participant Flow|Health Buddy Yes and Flexible Diuretic Yes|"Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.~Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges."
41391|NCT02344342|O4|Outcome|Health Buddy No and Flexible Diuretic No|"Telemonitoring: These patients will not be assigned to the Health Buddy Web intervention.~Flexible Diuretic Regimen: These patients will not be assigned to follow a flexible diuretic regimen."
41392|NCT02344342|O3|Outcome|Health Buddy No and Flexible Diuretic Yes|"Telemonitoring: These patients will not receive care with the Health Buddy Web intervention.~Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges."
41393|NCT02344342|O2|Outcome|Health Buddy Yes and Flexible Diuretic Regimen No|"Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.~Flexible Diuretic Regimen: These patients will not be assigned to receive a flexible diuretic prescription"
41394|NCT02344342|O1|Outcome|Health Buddy Yes and Flexible Diuretic Yes|"Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.~Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges."
41395|NCT02344342|O4|Outcome|Health Buddy No and Flexible Diuretic No|"Telemonitoring: No~Flexible Diuretic No"
41396|NCT02344342|O3|Outcome|Health Buddy No and Flexible Diuretic Yes|"Telemonitoring: No~Flexible Diuretic Yes"
41397|NCT02344342|O2|Outcome|Health Buddy Yes and Flexible Diuretic No|"Telemonitoring: Yes~Flexible Diuretic No"
41398|NCT02344342|O1|Outcome|Health Buddy Yes and Flexible Diuretic Yes|"Telemonitoring: Yes~Flexible Diuretic Yes"
41399|NCT02344342|O4|Outcome|Health Buddy No and Flexible Diuretic No|"Telemonitoring: No~Flexible Diuretic No"
41400|NCT02344342|O3|Outcome|Health Buddy No and Flexible Diuretic Yes|"Telemonitoring: No~Flexible Diuretic Yes"
41401|NCT02344342|O2|Outcome|Health Buddy Yes and Flexible Diuretic No|"Telemonitoring: Yes~Flexible Diuretic No"
41402|NCT02344342|O1|Outcome|Health Buddy Yes and Flexible Diuretic Yes|"Telemonitoring: Yes~Flexible Diuretic Yes"
41403|NCT02344342|O4|Outcome|Health Buddy No and Flexible Diuretic No|"Telemonitoring: No~Flexible Diuretic No"
41404|NCT02344342|O3|Outcome|Health Buddy No and Flexible Diuretic Yes|"Telemonitoring: No~Flexible Diuretic Yes"
41405|NCT02344342|O2|Outcome|Health Buddy Yes and Flexible Diuretic No|"Telemonitoring: Yes~Flexible Diuretic No"
41406|NCT02344342|O1|Outcome|Health Buddy Yes and Flexible Diuretic Yes|"Telemonitoring: Yes~Flexible Diuretic Yes"
41407|NCT02344342|E4|Reported Event|Health Buddy Web NO /Flexible Diuretic NO|"Telemonitoring: These patients will not be assigned to the Health Buddy Web intervention.~Flexible Diuretic Regimen: These patients will not be assigned to follow a flexible diuretic regimen."
41408|NCT02344342|E3|Reported Event|Health Buddy Web NO/Flexible Diuretic YES|"Telemonitoring: These patients will not receive care with the Health Buddy Web intervention.~Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges."
41409|NCT02344342|E2|Reported Event|Health Buddy Web YES /Flexible Diuretic NO|"Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.~Flexible Diuretic Regimen: These patients will not be assigned to receive a flexible diuretic prescription"
41805|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
41410|NCT02344342|E1|Reported Event|Health Buddy Web YES/Flexible Diuretic YES|"Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.~Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges."
41411|NCT02344251|B3|Baseline|Total|Total of all reporting groups
41412|NCT02344251|B2|Baseline|Group 2|"Compliance measured by ID-Cap technology~ID-Cap: ID-Cap Tag is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract."
41413|NCT02344251|B1|Baseline|Group 1|"Compliance measured by MEMS Cap~MEMS Cap: MEMS Track Cap records when the medication bottle is opened and closed"
41414|NCT02344251|P2|Participant Flow|ID Cap Tag|"Compliance measured by riboflavin, self-report, and ID-Cap technology.~ID-Cap: ID-Cap Tag is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract.~Riboflavin: 50 mg"
41415|NCT02344251|P1|Participant Flow|MEMS Track Cap|"Compliance measured by MEMS Cap, riboflavin and self-report.~MEMS Cap: MEMS Track Cap records when the medication bottle is opened and closed~Riboflavin: 50 mg"
41416|NCT02344251|O2|Outcome|ID Cap|"Compliance measured by ID-Cap technology.~ID-Cap: ID-Cap Tag is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract."
41417|NCT02344251|O1|Outcome|MEMS Track Cap|"Compliance measured by MEMS Cap~MEMS Cap: MEMS Track Cap records when the medication bottle is opened and closed"
41418|NCT02344251|O2|Outcome|ID Cap|"Adherence measured by ID-Cap technology.~ID-Capsule: ID-Capsule is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract."
41419|NCT02344251|O1|Outcome|MEMS Track Cap|"Adherence measured by MEMS Cap~MEMS Cap: MEMS Track Cap records when the medication bottle is opened and closed"
41420|NCT02344251|E2|Reported Event|Group 2|"Compliance measured by ID-Cap technology.~ID-Cap: ID-Cap Tag is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract."
41421|NCT02344251|E1|Reported Event|Group 1|"Compliance measured by MEMS Cap~MEMS Cap: MEMS Track Cap records when the medication bottle is opened and closed"
41422|NCT02343380|B3|Baseline|Total|Total of all reporting groups
41423|NCT02343380|B2|Baseline|Evening-first, Then Morning|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
41424|NCT02343380|B1|Baseline|Morning-first, Then Evening|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
41425|NCT02343380|P2|Participant Flow|Evening-first, Then Morning|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
41426|NCT02343380|P1|Participant Flow|Morning-first, Then Evening|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
41427|NCT02343380|O2|Outcome|Evening|Variation in morning glucagon-like peptide 1 Area-Under the Curve (AUC)s after the consumption of a meal at 8:00
41428|NCT02343380|O1|Outcome|Morning|Variation in morning glucagon-like peptide 1 Area-Under the Curve (AUC)s after the consumption of a meal at 8:00 am
41429|NCT02343380|O2|Outcome|Evening|Variation in evening acylated ghrelin Area-Under the Curve (AUC)s after the consumption of a meal at 8:00 pm
41430|NCT02343380|O1|Outcome|Morning|Variation in morning acylated ghrelin Area-Under the Curve (AUC)s after the consumption of a meal at 8:00 am
41431|NCT02343380|O2|Outcome|Evening|Variation in evening adrenalin and noradrenalin Area-Under the Curve (AUC)s after the consumption of a meal at 8:00
41432|NCT02343380|O1|Outcome|Morning|Variation in morning adrenalin and noradrenalin Area-Under the Curve (AUC)s after the consumption of a meal at 8:00 am
41433|NCT02343380|O2|Outcome|Evening|"Variation in morning triglyceride and free fatty acid (FFA) Area-Under the Curve (AUC)s after the consumption of a meal at 8:00 pm~The metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
41434|NCT02343380|O1|Outcome|Morning|"Variation in morning triglyceride and free fatty acid (FFA) Area-Under the Curve (AUC)s after the consumption of a meal at 8:00 am.~The metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
41435|NCT02343380|O2|Outcome|Evening|Variation in morning glucose and insulin Area-Under the Curve (AUC)s after the consumption of a meal at 8:00 pm
41436|NCT02343380|O1|Outcome|Morning|Variation in morning glucose and insulin Area-Under the Curve (AUC)s after the consumption of a meal at 8:00
41437|NCT02343380|O2|Outcome|Evening|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
41438|NCT02343380|O1|Outcome|Morning|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
41806|NCT02341482|E3|Reported Event|PF-04958242 0.025 mg Combined With Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg combined with itraconazole 200 mg orally.
41439|NCT02343380|E2|Reported Event|Evening|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
41440|NCT02343380|E1|Reported Event|Morning|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
41441|NCT02343159|B4|Baseline|Total|Total of all reporting groups
41442|NCT02343159|B3|Baseline|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41443|NCT02343159|B2|Baseline|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41444|NCT02343159|B1|Baseline|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41445|NCT02343159|P3|Participant Flow|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41446|NCT02343159|P2|Participant Flow|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41447|NCT02343159|P1|Participant Flow|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41448|NCT02343159|O3|Outcome|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41449|NCT02343159|O2|Outcome|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41450|NCT02343159|O1|Outcome|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41451|NCT02343159|O3|Outcome|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41452|NCT02343159|O2|Outcome|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41453|NCT02343159|O1|Outcome|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41454|NCT02343159|O3|Outcome|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41455|NCT02343159|O2|Outcome|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41456|NCT02343159|O1|Outcome|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41457|NCT02343159|O3|Outcome|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41458|NCT02343159|O2|Outcome|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41459|NCT02343159|O1|Outcome|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41460|NCT02343159|O2|Outcome|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41461|NCT02343159|O1|Outcome|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41462|NCT02343159|O2|Outcome|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41463|NCT02343159|O1|Outcome|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41464|NCT02343159|O2|Outcome|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41465|NCT02343159|O1|Outcome|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41466|NCT02343159|O2|Outcome|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41467|NCT02343159|O1|Outcome|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41468|NCT02343159|E3|Reported Event|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41469|NCT02343159|E2|Reported Event|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41470|NCT02343159|E1|Reported Event|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
41471|NCT02343081|B3|Baseline|Total|Total of all reporting groups
41472|NCT02343081|B2|Baseline|Dralitem, Then Temodal|During days 1 and 2, all patients received a single oral dose of 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 3 patients received 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®) as a single oral dose. After a washout period of 10 hours, they then received 200 mg/m2 of Temozolomide from Schering-Plough (Temodal®). On day 5 all patients received Temozolomide 200 mg/m2 from Monte Verde S.A.(Dralitem®). All patients were under fasting conditions two hours before and after each drug administration.
41473|NCT02343081|B1|Baseline|Temodal, Then Dralitem|During days 1 and 2, all patients received a single oral dose of 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 3 patients received 200 mg/m2 of Temozolomide from Schering-Plough (Temodal®) as a single oral dose. After a washout period of 10 hours, they then received 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 5 all patients received Temozolomide 200 mg/m2 from Monte Verde S.A. (Dralitem®).All patients were under fasting conditions two hours before and after each drug administration.
41474|NCT02343081|P2|Participant Flow|Dralitem, Then Temodal|During days 1 and 2, all patients received a single oral dose of 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 3 patients received 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®) as a single oral dose. After a washout period of 10 hours, they then received 200 mg/m2 of Temozolomide from Schering-Plough (Temodal®). On day 5 all patients received Temozolomide 200 mg/m2 from Monte Verde S.A.(Dralitem®). All patients were under fasting conditions two hours before and after each drug administration.
41475|NCT02343081|P1|Participant Flow|Temodal, Then Dralitem|During days 1 and 2, all patients received a single oral dose of 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 3 patients received 200 mg/m2 of Temozolomide from Schering-Plough (Temodal®) as a single oral dose. After a washout period of 10 hours, they then received 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 5 all patients received Temozolomide 200 mg/m2 from Monte Verde S.A. (Dralitem®).All patients were under fasting conditions two hours before and after each drug administration.
41476|NCT02343081|O2|Outcome|Dralitem|"Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose~Temozolomide"
41477|NCT02343081|O1|Outcome|Temodal|"Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.~Temozolomide"
41478|NCT02343081|O2|Outcome|Dralitem|"Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose~Temozolomide"
41479|NCT02343081|O1|Outcome|Temodal|"Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.~Temozolomide"
41480|NCT02343081|O2|Outcome|Dralitem|"Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose~Temozolomide"
41481|NCT02343081|O1|Outcome|Temodal|"Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.~Temozolomide"
41482|NCT02343081|O2|Outcome|Dralitem|"Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose~Temozolomide"
41483|NCT02343081|O1|Outcome|Temodal|"Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.~Temozolomide"
41484|NCT02343081|O2|Outcome|Dralitem|"Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose~Temozolomide"
41485|NCT02343081|O1|Outcome|Temodal|"Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.~Temozolomide"
41486|NCT02343081|E2|Reported Event|Dralitem|Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose.
41487|NCT02343081|E1|Reported Event|Temodal|Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.
41488|NCT02343003|B3|Baseline|Total|Total of all reporting groups
41489|NCT02343003|B2|Baseline|Corticosteroid Injection|"Corticosteroid injections will be administered to study subjects' knees to reduce knee pain~Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain"
41490|NCT02343003|B1|Baseline|Cooled Radiofrequency|"Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain~Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe"
41491|NCT02343003|P2|Participant Flow|Corticosteroid Injection|"Corticosteroid injections will be administered to study subjects' knees to reduce knee pain~Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain"
41492|NCT02343003|P1|Participant Flow|Cooled Radiofrequency|"Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain~Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe"
41493|NCT02343003|O2|Outcome|Corticosteroid Injection|"Corticosteroid injections will be administered to study subjects' knees to reduce knee pain~Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain"
41494|NCT02343003|O1|Outcome|Cooled Radiofrequency|"Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain~Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe"
41495|NCT02343003|O2|Outcome|Corticosteroid Injection|"Corticosteroid injections will be administered to study subjects' knees to reduce knee pain~Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain"
41807|NCT02341482|E2|Reported Event|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
41496|NCT02343003|O1|Outcome|Cooled Radiofrequency|"Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain~Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe"
41497|NCT02343003|O2|Outcome|Corticosteroid Injection|"Corticosteroid injections will be administered to study subjects' knees to reduce knee pain~Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain"
41498|NCT02343003|O1|Outcome|Cooled Radiofrequency|"Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain~Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe"
41499|NCT02343003|O2|Outcome|Corticosteroid Injection|"Corticosteroid injections will be administered to study subjects' knees to reduce knee pain~Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain"
41500|NCT02343003|O1|Outcome|Cooled Radiofrequency|"Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain~Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe"
41501|NCT02343003|O2|Outcome|Corticosteroid Injection|"Corticosteroid injections will be administered to study subjects' knees to reduce knee pain~Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain"
41502|NCT02343003|O1|Outcome|Cooled Radiofrequency|"Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain~Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe"
41503|NCT02343003|O2|Outcome|Corticosteroid Injection|"Corticosteroid injections will be administered to study subjects' knees to reduce knee pain~Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain"
41504|NCT02343003|O1|Outcome|Cooled Radiofrequency|"Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain~Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe"
41505|NCT02343003|E2|Reported Event|Corticosteroid Injection|"Corticosteroid injections will be administered to study subjects' knees to reduce knee pain~Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain"
41506|NCT02343003|E1|Reported Event|Cooled Radiofrequency|"Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain~Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe"
41507|NCT02342704|B3|Baseline|Total|Total of all reporting groups
41508|NCT02342704|B2|Baseline|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
41509|NCT02342704|B1|Baseline|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
41510|NCT02342704|P2|Participant Flow|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
41511|NCT02342704|P1|Participant Flow|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
41512|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
41513|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
41514|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
41515|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
41516|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
41517|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
41518|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
41519|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
41520|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
41521|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
41522|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
41523|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
41524|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
41525|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
41526|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
41527|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
41528|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
41529|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
41530|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
41531|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
41532|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
41533|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
41534|NCT02342704|E2|Reported Event|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
41535|NCT02342704|E1|Reported Event|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
41536|NCT02342561|B1|Baseline|Intervention Knees (Draped Knees) and Control Knees (No-draped|"One knee of the patient is randomly selected to be drape with an Ioban 2 incision drape.~Ioban 2 incision drape, 3M: The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions.~The knee that is not drape is left uncovered during the intervention."
41537|NCT02342561|P1|Participant Flow|Intervention Knee (Drape Side) and Control Knee (No Drape Side|"One knee of the patient is randomly selected to be drape with an Ioban 2 incision drape.~Ioban 2 incision drape, 3M: The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions.~The control knee that is not drape is left uncovered during the intervention."
41538|NCT02342561|O2|Outcome|Control Knees (No-drape Side)|The knees were not drape were left uncovered during the intervention.
41539|NCT02342561|O1|Outcome|Intervention Knees (Drape Side)|"One knee of the patient were randomly selected to be draped with an Ioban 2 incision drape.~Ioban 2 incision drape, 3M: The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions."
41541|NCT02342561|O1|Outcome|Intervention Knee (Draped Knees)|"One knee of the patient is randomly selected to be drape with an Ioban 2 incision drape.~Ioban 2 incision drape, 3M: The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions."
41542|NCT02342561|E2|Reported Event|Control Knees|The knees that were not drape is left uncovered during the intervention.
41543|NCT02342561|E1|Reported Event|Intervention Knees|"One knee of the patient were randomly selected to be drape with an Ioban 2 incision drape.~Ioban 2 incision drape, 3M: The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions."
41544|NCT02342548|B4|Baseline|Total|Total of all reporting groups
41545|NCT02342548|B3|Baseline|Placebo and Titration up to 20 mg PF-02545920|Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41546|NCT02342548|B2|Baseline|5 mg PF-02545920 Titration up to 20 mg|Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41547|NCT02342548|B1|Baseline|20 mg PF-02545920|Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
41548|NCT02342548|P3|Participant Flow|Placebo and Titration up to 20 mg PF-02545920|Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41549|NCT02342548|P2|Participant Flow|5 mg PF-02545920 Titration up to 20 mg|Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41550|NCT02342548|P1|Participant Flow|20 mg PF-02545920|Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
41551|NCT02342548|O3|Outcome|Placebo and Titration up to 20 mg PF-02545920|Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41552|NCT02342548|O2|Outcome|5 mg PF-02545920 Titration up to 20 mg|Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41553|NCT02342548|O1|Outcome|20 mg PF-02545920|Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
41554|NCT02342548|O3|Outcome|Placebo and Titration up to 20 mg PF-02545920|Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41555|NCT02342548|O2|Outcome|5 mg PF-02545920 Titration up to 20 mg|Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41556|NCT02342548|O1|Outcome|20 mg PF-02545920|Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
41557|NCT02342548|O3|Outcome|Placebo and Titration up to 20 mg PF-02545920|Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41558|NCT02342548|O2|Outcome|5 mg PF-02545920 Titration up to 20 mg|Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41559|NCT02342548|O1|Outcome|20 mg PF-02545920|Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
41560|NCT02342548|O3|Outcome|Placebo and Titration up to 20 mg PF-02545920|Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
67792|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
41561|NCT02342548|O2|Outcome|5 mg PF-02545920 Titration up to 20 mg|Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41562|NCT02342548|O1|Outcome|20 mg PF-02545920|Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
41563|NCT02342548|O3|Outcome|Placebo and Titration up to 20 mg PF-02545920|Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41564|NCT02342548|O2|Outcome|5 mg PF-02545920 Titration up to 20 mg|Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41565|NCT02342548|O1|Outcome|20 mg PF-02545920|Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
41566|NCT02342548|O3|Outcome|Placebo and Titration up to 20 mg PF-02545920|Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41567|NCT02342548|O2|Outcome|5 mg PF-02545920 Titration up to 20 mg|Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41568|NCT02342548|O1|Outcome|20 mg PF-02545920|Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
41569|NCT02342548|O3|Outcome|Placebo and Titration up to 20 mg PF-02545920|Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41570|NCT02342548|O2|Outcome|5 mg PF-02545920 Titration up to 20 mg|Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41571|NCT02342548|O1|Outcome|20 mg PF-02545920|Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
41572|NCT02342548|O3|Outcome|Placebo and Titration up to 20 mg PF-02545920|Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41573|NCT02342548|O2|Outcome|5 mg PF-02545920 Titration up to 20 mg|Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41574|NCT02342548|O1|Outcome|20 mg PF-02545920|Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
41575|NCT02342548|O3|Outcome|Placebo and Titration up to 20 mg PF-02545920|Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41576|NCT02342548|O2|Outcome|5 mg PF-02545920 Titration up to 20 mg|Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41577|NCT02342548|O1|Outcome|20 mg PF-02545920|Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
41578|NCT02342548|O3|Outcome|Placebo and Titration up to 20 mg PF-02545920|Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41665|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41579|NCT02342548|O2|Outcome|5 mg PF-02545920 Titration up to 20 mg|Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41580|NCT02342548|O1|Outcome|20 mg PF-02545920|Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
41581|NCT02342548|O3|Outcome|Placebo and Titration up to 20 mg PF-02545920|Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41582|NCT02342548|O2|Outcome|5 mg PF-02545920 Titration up to 20 mg|Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41583|NCT02342548|O1|Outcome|20 mg PF-02545920|Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
41584|NCT02342548|E3|Reported Event|Placebo and Titration up to 20 mg PF-02545920|Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41585|NCT02342548|E2|Reported Event|5 mg PF-02545920 Titration up to 20 mg|Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
41586|NCT02342548|E1|Reported Event|20 mg PF-02545920|Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
41587|NCT02342535|B1|Baseline|Physical Activity Intervention|"Participants will attend bi weekly exercise classes for a total of 16 weeks, led by certified, and trained instructors.~The participant's children between the ages of 6 and 14 years will participate in the martial arts and yoga class with their mothers.~Physical Activity: Culturally tailored physical activity intervention for South Asian women and their children."
41588|NCT02342535|P1|Participant Flow|Physical Activity Intervention|"Participants will attend bi weekly exercise classes for a total of 16 weeks, led by certified, and trained instructors.~The participant's children between the ages of 6 and 14 years will participate in the martial arts class with the mothers.~Physical Activity: Culturally tailored physical activity intervention for South Asian women and their children."
41589|NCT02342535|O1|Outcome|Physical Activity Intervention|"Participants will attend bi weekly exercise classes for a total of 16 weeks, led by certified, and trained instructors.~The participant's children between the ages of 6 and 14 years will participate in the kids exercise class with their mothers.~Physical Activity: Culturally tailored physical activity intervention for South Asian women and their children."
41590|NCT02342535|E1|Reported Event|Physical Activity Intervention|"Participants will attend bi weekly exercise classes for a total of 16 weeks, led by certified, and trained instructors.~The participant's children between the ages of 6 and 14 years will participate in the kids exercise class with their mothers.~Physical Activity: Culturally tailored physical activity intervention for South Asian women and their children."
41591|NCT02342418|B3|Baseline|Total|Total of all reporting groups
41592|NCT02342418|B2|Baseline|Non-obese|"Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
41593|NCT02342418|B1|Baseline|Morbidly Obese|"The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
41594|NCT02342418|P2|Participant Flow|Non-obese|"Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
41595|NCT02342418|P1|Participant Flow|Morbidly Obese|"The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
41596|NCT02342418|O2|Outcome|Non-obese|"Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
44132|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
41597|NCT02342418|O1|Outcome|Morbidly Obese|"The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
41598|NCT02342418|O2|Outcome|Non-obese|"Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
41599|NCT02342418|O1|Outcome|Morbidly Obese|"The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
41600|NCT02342418|E2|Reported Event|Non-obese|"Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
41601|NCT02342418|E1|Reported Event|Morbidly Obese|"The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
41602|NCT02342288|B3|Baseline|Total|Total of all reporting groups
41603|NCT02342288|B2|Baseline|Head in Neutral Position|"Head in neutral position~Head in neutral position: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
41604|NCT02342288|B1|Baseline|Head Raised 10 Degrees|"Head raised 10 degrees from neutral position using Gardner Wells tongs~Head raised 10 degrees: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
41605|NCT02342288|P2|Participant Flow|Head in Neutral Position|"Head in neutral position~Head in neutral position: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
41606|NCT02342288|P1|Participant Flow|Head Raised 10 Degrees|"Head raised 10 degrees from neutral position using Gardner Wells tongs~Head raised 10 degrees: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
41607|NCT02342288|O2|Outcome|Head in Neutral Position|"Head in neutral position~Head in neutral position: Five minutes after turning prone, an IOP measurement was obtained. After 5 minutes an IOP measurement was taken. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
41608|NCT02342288|O1|Outcome|Head Raised 10 Degrees|"Head raised 10 degrees from neutral position using Gardner Wells tongs~Head raised 10 degrees: Five minutes after turning prone, an IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes an IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
41609|NCT02342288|E2|Reported Event|Head in Neutral Position|"Head in neutral position~Head in neutral position: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
41666|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
67793|NCT02153489|O2|Outcome|Placebo|Placebo BID
41610|NCT02342288|E1|Reported Event|Head Raised 10 Degrees|"Head raised 10 degrees from neutral position using Gardner Wells tongs~Head raised 10 degrees: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
41611|NCT02342223|B1|Baseline|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
41612|NCT02342223|P1|Participant Flow|Voluma Treatment of HIV Facial Lipoatrophy|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
41613|NCT02342223|O1|Outcome|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
41614|NCT02342223|O1|Outcome|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
41615|NCT02342223|O1|Outcome|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
41616|NCT02342223|O1|Outcome|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
41617|NCT02342223|O1|Outcome|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
41618|NCT02342223|O1|Outcome|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
41619|NCT02342223|E1|Reported Event|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
41620|NCT02342197|B3|Baseline|Total|Total of all reporting groups
41621|NCT02342197|B2|Baseline|Microdose Flare Protocol|"Half the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's~Decapeptyl: half the dose of Gn agonist"
41622|NCT02342197|B1|Baseline|Minidose Long Protocol|"Half dose of GnRH agonist (Decapeptyl 0.05) was started in the midluteal phase and Gn's was started from the second day of the cycle.~Decapeptyl: half the dose of Gn agonist"
41623|NCT02342197|P2|Participant Flow|Microdose Flare Protocol|"Half the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's~Decapeptyl: half the dose of Gn agonist"
41624|NCT02342197|P1|Participant Flow|Minidose Long Protocol|"Half dose of GnRH agonist (Decapeptyl 0.05) was started in the midluteal phase and Gn's was started from the second day of the cycle.~Decapeptyl: half the dose of Gn agonist"
41625|NCT02342197|O2|Outcome|Microdose Flare Protocol|"Half the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's~Decapeptyl: half the dose of Gn agonist"
41626|NCT02342197|O1|Outcome|Minidose Long Protocol|"Half dose of GnRH agonist (Decapeptyl 0.05) was started in the midluteal phase and Gn's was started from the second day of the cycle.~Decapeptyl: half the dose of Gn agonist"
41627|NCT02342197|E2|Reported Event|Microdose Flare Protocol|"Half the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's~Decapeptyl: half the dose of Gn agonist"
41628|NCT02342197|E1|Reported Event|Minidose Long Protocol|"Half dose of GnRH agonist (Decapeptyl 0.05) was started in the midluteal phase and Gn's was started from the second day of the cycle.~Decapeptyl: half the dose of Gn agonist"
41629|NCT02341859|B1|Baseline|Overall Participant Flow|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally or the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens~narafilcon A: contact lens"
41808|NCT02341482|E1|Reported Event|PF-04958242 0.1 mg|All participants who received PF-04958242 0.1 mg BID orally.
41630|NCT02341859|P2|Participant Flow|Stenfilcon A/Narafilcon A, Then Stenfilcon A/Delefilcon A|"Participants randomized wear the stenfilcon A and narafilcon A lens pair contralaterally, and then cross over to wear the stenfilcon A and delefilcon A lens pair contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens~delefilcon A: contact lens"
41631|NCT02341859|P1|Participant Flow|Stenfilcon A/Delefilcon A, Then Stenfilcon A/Narafilcon A|"Participants randomized wear the stenfilcon A and delefilcon A lens pair contralaterally, and then cross over to wear the stenfilcon A and narafilcon A lens pair contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens~narafilcon A: contact lens"
41632|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41633|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41634|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41635|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41636|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41637|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41638|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41639|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41640|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41641|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41642|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41643|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41644|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41645|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41646|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41647|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41648|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41649|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41650|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41651|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41652|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41653|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41654|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41655|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41656|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41657|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41658|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41659|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41660|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41661|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41662|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41663|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41664|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41667|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41668|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41669|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41670|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41671|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41672|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41673|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41674|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41675|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41676|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41677|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41678|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41679|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41680|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41681|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41682|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41683|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41684|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41685|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41686|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41687|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41688|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41689|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41690|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41691|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41692|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41693|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41694|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41695|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41696|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41697|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41698|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41699|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41700|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41701|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41702|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41809|NCT02341417|B4|Baseline|Total|Total of all reporting groups
41703|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41704|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41705|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41706|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41707|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41708|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41709|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41710|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41711|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41712|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41713|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41714|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41715|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41716|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41717|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41718|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41719|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41720|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41721|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41722|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
41723|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
41724|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41725|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41726|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41727|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
41728|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41729|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41730|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41731|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
41732|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41733|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41734|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41735|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
41736|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41737|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41738|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
67794|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
41739|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
41740|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41741|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41742|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41743|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
41744|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41745|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41746|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41747|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
41748|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41749|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41750|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41751|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
41752|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41753|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41754|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41755|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
41756|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41757|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41758|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41759|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
41760|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41761|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41762|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41763|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
41764|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41765|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41766|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41767|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
41768|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41769|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41770|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41771|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
41772|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41773|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41774|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
67795|NCT02153489|O2|Outcome|Placebo|Placebo BID
41775|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
41776|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
41777|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41778|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
41779|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
41780|NCT02341859|E3|Reported Event|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
41781|NCT02341859|E2|Reported Event|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
41782|NCT02341859|E1|Reported Event|Stenfilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally or the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens~narafilcon A: contact lens"
41783|NCT02341482|B1|Baseline|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
41784|NCT02341482|P1|Participant Flow|All Subjects|PF-04958242 0.10 milligram (mg) loading dose was administered orally twice daily (BID) on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), once daily (QD).
41785|NCT02341482|O1|Outcome|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
41786|NCT02341482|O3|Outcome|PF-04958242 0.1 mg|All participants who received PF-04958242 0.1 mg BID orally.
41787|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
41788|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
41789|NCT02341482|O1|Outcome|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
41790|NCT02341482|O1|Outcome|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
41791|NCT02341482|O1|Outcome|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
41792|NCT02341482|O1|Outcome|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
41793|NCT02341482|O1|Outcome|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
41794|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
41795|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
41796|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
41797|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
41798|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
41799|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
41800|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
41801|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
41802|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
41803|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
41810|NCT02341417|B3|Baseline|20110100 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41811|NCT02341417|B2|Baseline|20130356 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41812|NCT02341417|B1|Baseline|20130356 SOC|Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41813|NCT02341417|P3|Participant Flow|20110100 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41814|NCT02341417|P2|Participant Flow|20130356 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41815|NCT02341417|P1|Participant Flow|20130356 SOC|Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41816|NCT02341417|O3|Outcome|20110100 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41817|NCT02341417|O2|Outcome|20130356 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41818|NCT02341417|O1|Outcome|20130356 SOC|Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41819|NCT02341417|O3|Outcome|20110100 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41820|NCT02341417|O2|Outcome|20130356 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41821|NCT02341417|O1|Outcome|20130356 SOC|Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41822|NCT02341417|O3|Outcome|20110100 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41823|NCT02341417|O2|Outcome|20130356 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
67796|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
41824|NCT02341417|O1|Outcome|20130356 SOC|Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41825|NCT02341417|O3|Outcome|20110100 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41826|NCT02341417|O2|Outcome|20130356 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41827|NCT02341417|O1|Outcome|20130356 SOC|Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41828|NCT02341417|O3|Outcome|20110100 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41829|NCT02341417|O2|Outcome|20130356 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41830|NCT02341417|O1|Outcome|20130356 SOC|Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41831|NCT02341417|O3|Outcome|20110100 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41832|NCT02341417|O2|Outcome|20130356 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41833|NCT02341417|O1|Outcome|20130356 SOC|Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41834|NCT02341417|O3|Outcome|20110100 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41835|NCT02341417|O2|Outcome|20130356 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41836|NCT02341417|O1|Outcome|20130356 SOC|Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41837|NCT02341417|O3|Outcome|20110100 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41934|NCT02340000|O2|Outcome|High Dose Time Period 1|extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days
41935|NCT02340000|O1|Outcome|Standard Dose Time Period I|amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
41838|NCT02341417|O2|Outcome|20130356 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41839|NCT02341417|O1|Outcome|20130356 SOC|Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41840|NCT02341417|O3|Outcome|20110100 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41841|NCT02341417|O2|Outcome|20130356 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41842|NCT02341417|O1|Outcome|20130356 SOC|Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41843|NCT02341417|O3|Outcome|20110100 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41844|NCT02341417|O2|Outcome|20130356 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41845|NCT02341417|O1|Outcome|20130356 SOC|Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41846|NCT02341417|O1|Outcome|20130356 SOC|Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41847|NCT02341417|O1|Outcome|20130356 SOC|Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41848|NCT02341417|O1|Outcome|20130356 SOC|Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41849|NCT02341417|O3|Outcome|20110100 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41850|NCT02341417|O2|Outcome|20130356 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41851|NCT02341417|O1|Outcome|20130356 SOC|Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41852|NCT02341417|E4|Reported Event|Total|All participants who received cinacalcet in study 20140159.
41867|NCT02341144|O2|Outcome|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon~Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.~Ropivacaine"
41853|NCT02341417|E3|Reported Event|20110100 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41854|NCT02341417|E2|Reported Event|20130356 SOC + Cinacalcet|Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41855|NCT02341417|E1|Reported Event|20130356 SOC|Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
41856|NCT02341144|B3|Baseline|Total|Total of all reporting groups
41857|NCT02341144|B2|Baseline|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon~Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.~Ropivacaine"
41858|NCT02341144|B1|Baseline|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist~Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.~Ropivacaine"
41859|NCT02341144|P2|Participant Flow|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon~Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.~Ropivacaine"
41860|NCT02341144|P1|Participant Flow|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist~Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.~Ropivacaine"
41861|NCT02341144|O2|Outcome|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon~Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.~Ropivacaine"
41862|NCT02341144|O1|Outcome|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist~Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.~Ropivacaine"
41863|NCT02341144|O2|Outcome|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon~Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.~Ropivacaine"
41864|NCT02341144|O1|Outcome|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist~Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.~Ropivacaine"
41865|NCT02341144|O2|Outcome|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon~Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.~Ropivacaine"
41866|NCT02341144|O1|Outcome|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist~Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.~Ropivacaine"
41936|NCT02340000|O4|Outcome|High Dose Time Period 2|immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
41868|NCT02341144|O1|Outcome|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist~Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.~Ropivacaine"
41869|NCT02341144|O2|Outcome|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon~Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.~Ropivacaine"
41870|NCT02341144|O1|Outcome|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist~Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.~Ropivacaine"
41871|NCT02341144|E2|Reported Event|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon~Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.~Ropivacaine"
41872|NCT02341144|E1|Reported Event|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist~Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.~Ropivacaine"
41873|NCT02340715|B1|Baseline|MRI for Treatment Planning or Follow up|MRI for treatment planning for radiation therapy or those who have completed treatment and are receiving follow up care.
41874|NCT02340715|P1|Participant Flow|MRI for Treatment Planning or Follow up|MRI for treatment planning for radiation therapy or those who have completed treatment and are receiving follow up care.
41875|NCT02340715|O1|Outcome|MRI for Treatment Planning or Follow up|Patients aged 18 years and older of any race or gender with brain, head and neck, breast, lung, cervix, sarcoma, pancreatic, or prostate cancer undergoing MRI scans for radiation treatment planning and/or treatment follow-up at FMLH.
41876|NCT02340715|E1|Reported Event|MRI for Treatment Planning or Follow up|MRI for treatment planning for radiation therapy or those who have completed treatment and are receiving follow up care.
41877|NCT02340338|B8|Baseline|Total|Total of all reporting groups
41878|NCT02340338|B7|Baseline|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41879|NCT02340338|B6|Baseline|Dose Group 6|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41880|NCT02340338|B5|Baseline|Dose Group 5|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41881|NCT02340338|B4|Baseline|Dose Group 4|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41922|NCT02340000|P1|Participant Flow|Standard Dose|"amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days~standard dose amoxicillin/clavulanate: amoxicillin/clavulanate 875/125 + placebo bid x 7 days"
41882|NCT02340338|B3|Baseline|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 1 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41883|NCT02340338|B2|Baseline|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 300 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41884|NCT02340338|B1|Baseline|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 100 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41885|NCT02340338|P7|Participant Flow|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41886|NCT02340338|P6|Participant Flow|Dose Group 6|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41887|NCT02340338|P5|Participant Flow|Dose Group 5|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41888|NCT02340338|P4|Participant Flow|Dose Group 4|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41889|NCT02340338|P3|Participant Flow|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 1 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41923|NCT02340000|O4|Outcome|High Dose Time Period 2|immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
41924|NCT02340000|O3|Outcome|Standard Dose Time Period 2|amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
41925|NCT02340000|O2|Outcome|High Dose Time Period 1|extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days
41926|NCT02340000|O1|Outcome|Standard Dose Time Period I|amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
41927|NCT02340000|O1|Outcome|Overall|First 231 participants
67797|NCT02153489|O2|Outcome|Placebo|Placebo BID
41890|NCT02340338|P2|Participant Flow|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 300 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41891|NCT02340338|P1|Participant Flow|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 100 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41892|NCT02340338|O7|Outcome|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41893|NCT02340338|O6|Outcome|Dose Group 6|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41894|NCT02340338|O5|Outcome|Dose Group 5|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41895|NCT02340338|O4|Outcome|Dose Group 4|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41896|NCT02340338|O3|Outcome|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 1 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41897|NCT02340338|O2|Outcome|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 300 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41928|NCT02340000|O4|Outcome|High Dose Time Period 2|immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
41929|NCT02340000|O3|Outcome|Standard Dose Time Period 2|amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
41930|NCT02340000|O2|Outcome|High Dose Time Period 1|extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days
41931|NCT02340000|O1|Outcome|Standard Dose Time Period I|amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
41932|NCT02340000|O4|Outcome|High Dose Time Period 2|immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
67798|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
41898|NCT02340338|O1|Outcome|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 100 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41899|NCT02340338|O7|Outcome|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41900|NCT02340338|O6|Outcome|Dose Group 6|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41901|NCT02340338|O5|Outcome|Dose Group 5|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41902|NCT02340338|O4|Outcome|Dose Group 4|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41903|NCT02340338|O3|Outcome|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 1 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41904|NCT02340338|O2|Outcome|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 300 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41905|NCT02340338|O1|Outcome|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 100 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41906|NCT02340338|E7|Reported Event|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41907|NCT02340338|E6|Reported Event|Dose Group 6|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41908|NCT02340338|E5|Reported Event|Dose Group 5|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41909|NCT02340338|E4|Reported Event|Dose Group 4|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41910|NCT02340338|E3|Reported Event|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 1 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41911|NCT02340338|E2|Reported Event|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 300 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41912|NCT02340338|E1|Reported Event|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 100 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
41913|NCT02340104|B1|Baseline|All Participants|Single oral dose of 4 mg baricitinib on Day 1 and at the same time a single intravenous (IV) infusion of 4 µg [^13C4D3^15N]-baricitinib over 1.5 hours.
41914|NCT02340104|P1|Participant Flow|Baricitinib|Single oral dose of 4 mg baricitinib on Day 1 and approximately the same time a single intravenous (IV) infusion of 4 µg [^13C4D3^15N]-baricitinib over 1.5 hours.
41915|NCT02340104|O2|Outcome|[^13C4D3^15N]-Baricitinib IV|Single intravenous (IV) infusion of 4 µg[^13C4D3^15N]-baricitinib over 1.5 hours
41916|NCT02340104|O1|Outcome|Baricitinib Oral Dose|Single oral dose of 4 mg baricitinib
41917|NCT02340104|E1|Reported Event|Baricitinib|Single oral dose of 4 mg baricitinib on Day 1 and at the same time a single intravenous (IV) infusion of 4 µg [^13C4D3^15N]-baricitinib over 1.5 hours
41918|NCT02340000|B3|Baseline|Total|Total of all reporting groups
41919|NCT02340000|B2|Baseline|High Dose|"Time Period I (November 18, 2014-January 5, 2016): extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets (by different manufacturer) twice a day for 7 days Time Period 2 (February 6, 2016-February 27, 2017): immediate-release amoxicillin/clavunate 875/125 mg plus standard immediate-release amoxicillin 875 mg twice a day for 7 days~high dose amoxicillin/clavulanate: Time Period I: extended-release amoxicillin/clavulanate 1000/62.5 two tablets bid x 7 days Time Period 2: immediate-release amoxicillin/clavulanate 875/125 plus amoxicllin 875 bid x 7 days"
41920|NCT02340000|B1|Baseline|Standard Dose|"amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days~standard dose amoxicillin/clavulanate: amoxicillin/clavulanate 875/125 + placebo bid x 7 days"
41921|NCT02340000|P2|Participant Flow|High Dose|"Time Period I (November 18, 2014-January 5, 2016): extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets (by different manufacturer) twice a day for 7 days Time Period 2 (February 6, 2016-February 27, 2017): immediate-release amoxicillin/clavunate 875/125 mg plus standard immediate-release amoxicillin 875 mg twice a day for 7 days~high dose amoxicillin/clavulanate: Time Period I: extended-release amoxicillin/clavulanate 1000/62.5 two tablets bid x 7 days Time Period 2: immediate-release amoxicillin/clavulanate 875/125 plus amoxicllin 875 bid x 7 days"
41938|NCT02340000|O2|Outcome|High Dose Time Period 1|extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days
41939|NCT02340000|O1|Outcome|Standard Dose Time Period I|amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
41940|NCT02340000|O4|Outcome|High Dose Time Period 2|immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
41941|NCT02340000|O3|Outcome|Standard Dose Time Period 2|Amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
41942|NCT02340000|O2|Outcome|High Dose Time Period 1|extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days
41943|NCT02340000|O1|Outcome|Standard Dose Time Period I|"amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days~standard dose amoxicillin/clavulanate: amoxicillin/clavulanate 875/125 + placebo bid x 7 days"
41944|NCT02340000|E4|Reported Event|High Dose Time Period 2|immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
41945|NCT02340000|E3|Reported Event|Standard Dose Time Period 2|amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
41946|NCT02340000|E2|Reported Event|High Dose Time Period 1|extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days
41947|NCT02340000|E1|Reported Event|Standard Dose Time Period I|amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
41948|NCT02339831|B3|Baseline|Total|Total of all reporting groups
41949|NCT02339831|B2|Baseline|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
41950|NCT02339831|B1|Baseline|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
41951|NCT02339831|P2|Participant Flow|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
41952|NCT02339831|P1|Participant Flow|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
41953|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
41954|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
41955|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
41956|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
41957|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
41958|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
41959|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
41960|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
41961|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
41962|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
41963|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
41964|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
41965|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
41966|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
41967|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
41968|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
41969|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
41970|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
41971|NCT02339831|E2|Reported Event|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
41972|NCT02339831|E1|Reported Event|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
41973|NCT02339584|B3|Baseline|Total|Total of all reporting groups
41974|NCT02339584|B2|Baseline|Brinz+Brim|Brimonidine 2 mg/mL eye drops, solution, 1 drop, followed by Brinzolamide 10 mg/mL eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) BID for 3 months
41975|NCT02339584|B1|Baseline|Brinz/Brim|Vehicle solution, 1 drop, followed by Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) twice daily (BID) for 3 months
41976|NCT02339584|P2|Participant Flow|Brinz+Brim|Brimonidine 2 mg/mL eye drops, solution, 1 drop, followed by Brinzolamide 10 mg/mL eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) BID for 3 months
41977|NCT02339584|P1|Participant Flow|Brinz/Brim|Vehicle solution, 1 drop, followed by Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) twice daily (BID) for 3 months
41978|NCT02339584|O2|Outcome|Brinz+Brim|Brimonidine 2 mg/mL eye drops, solution, 1 drop, followed by Brinzolamide 10 mg/mL eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) BID for 3 months
41979|NCT02339584|O1|Outcome|Brinz/Brim|Vehicle solution, 1 drop, followed by Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) twice daily (BID) for 3 months
41980|NCT02339584|E2|Reported Event|Brinz+Brim|All subjects exposed to Brinz+Brim
41981|NCT02339584|E1|Reported Event|Brinz/Brim|All subjects exposed to Brinz/Brim
41982|NCT02339506|B1|Baseline|Healthy Control|
41983|NCT02339506|P2|Participant Flow|Cosyntropin (Period 1)/Washout (Period 2)/ Placebo (Period 3)|"Period 1: Subjects will receive a cosyntropin infusion at 70 mcg/hr for two sessions of 2.5 hours each on day 2 of their first three day admission to our research center.~Period 2: Washout for one month Period 3: Subjects will receive a placebo infusion for two sessions of 2.5 hours each on day 2 of their second three day admission to our research center."
41984|NCT02339506|P1|Participant Flow|Placebo (Period 1)/Washout (Period 2)/Cosyntropin (Period 3)|"Period 1: Subjects will receive a placebo infusion for two sessions of 2.5 hours each on day 2 of their first three day admission to our research center.~Period 2: Washout for one month Period 3: Subjects will receive cosyntropin infusion at 70 mcg/hr for two sessions of 2.5 hours each on day 2 of their second three day admission to our research center."
41985|NCT02339506|O2|Outcome|Normal Saline (Placebo)|"Subjects will receive normal saline infusion for two sessions of 2.5 hours each on day 2 of a three day admission to our research center.~Placebo: Subjects will receive placebo (normal saline infusion) for two sessions of 2.5 hours each on day 2 of a three day admission to our research center."
41986|NCT02339506|O1|Outcome|Cosyntropin|"Subjects will receive cosyntropin infusion at 70 mcg/hr for two sessions of 2.5 hours each on day 2 of a three day admission to our research center.~Cosyntropin: Subjects will receive cosyntropin at 70 mcg/hr for two sessions of 2.5 hours each on day 2 of a three day admission to our research center."
41987|NCT02339506|E2|Reported Event|Cosyntropin|
41988|NCT02339506|E1|Reported Event|Placebo|
41989|NCT02339389|B1|Baseline|Study Group|"We are simply measuring ventilation changes that occur following labor analgesia.~Labor analgesia: Measuring maternal ventilation after placement of epidural analgesia compared to baseline"
41990|NCT02339389|P1|Participant Flow|Study Group|Maternal ventilation was measured non-invasively using the ExSpiron Respiratory Volume Monitor (RVM) in forty-one term parturients who received labor epidural analgesia. Minute ventilation (MV), respiratory rate (RR), and tidal volume (TV) were measured via chest pads using bio-impedance technology. In addition, we recorded vital signs and maternal oral temperature at 5, 10, 15, 20, 25, 30 and 60 min after epidural analgesia initiation, and then every hour until delivery.
41991|NCT02339389|O1|Outcome|Ventilation During Labor Analgesia|"We are simply measuring ventilation changes that occur following labor analgesia.~Labor analgesia: Measuring maternal ventilation after placement of epidural analgesia compared to baseline"
41992|NCT02339389|O1|Outcome|Study Group|Maternal ventilation was measured non-invasively using the ExSpiron Respiratory Volume Monitor (RVM) in forty-one term parturients who received labor epidural analgesia. Minute ventilation (MV), respiratory rate (RR), and tidal volume (TV) were measured via chest pads using bio-impedance technology. In addition, we recorded vital signs and maternal oral temperature at 5, 10, 15, 20, 25, 30 and 60 min after epidural analgesia initiation, and then every hour until delivery.
41993|NCT02339389|E1|Reported Event|Ventilation During Labor Analgesia|"We are simply measuring ventilation changes that occur following labor analgesia.~Labor analgesia: Measuring maternal ventilation after placement of epidural analgesia compared to baseline"
41994|NCT02339246|B3|Baseline|Total|Total of all reporting groups
41995|NCT02339246|B2|Baseline|Prograf vs Astagraf XL vs Envarsus XR|"Prograf capsules twice daily Astagraf XL capsules once daily Envarsus XR tablets once daily~Prograf vs Astagraf XL vs Envarsus XR: Prograf vs Astagraf XL vs Envarsus XR"
41996|NCT02339246|B1|Baseline|Prograf vs Envarsus XR vs Astagraf XL|"Prograft capsules Twice daily Envarsus XR tablets once daily Astagraf XL capsules once daily~Prograf vs Envarsus XR vs Astagraf XL: prograf vs Envarsus XR vs Astagraf XL"
41997|NCT02339246|P3|Participant Flow|Prograf|Prograf capsules twice daily.
41998|NCT02339246|P2|Participant Flow|Astagraf XL|Astagraf XL capsules once daily.
41999|NCT02339246|P1|Participant Flow|Envarsus XR|Envarsus XR tablets once daily.
42000|NCT02339246|O3|Outcome|Prograf|Prograf capsules twice daily.
42001|NCT02339246|O2|Outcome|Astagraf XL|Astagraf XL capsules once daily.
42002|NCT02339246|O1|Outcome|Envarsus XR|Envarsus XR tablets once daily.
42003|NCT02339246|O3|Outcome|Prograf|Prograf capsules twice daily.
42004|NCT02339246|O2|Outcome|Astagraf XL|Astagraf XL capsules once daily.
42005|NCT02339246|O1|Outcome|Envarsus XR|Envarsus XR tablets once daily.
42006|NCT02339246|O3|Outcome|Prograf|Prograf capsules twice daily.
42007|NCT02339246|O2|Outcome|Astagraf XL|Astagraf XL capsules once daily.
42008|NCT02339246|O1|Outcome|Envarsus XR|Envarsus XR tablets once daily.
42009|NCT02339246|E3|Reported Event|Prograf|Prograf capsules twice daily.
42010|NCT02339246|E2|Reported Event|Astagraf XR|Astagraf XR capsules once daily.
42011|NCT02339246|E1|Reported Event|Envarsus XR|Envarsus XR tablets once daily.
42012|NCT02339155|B3|Baseline|Total|Total of all reporting groups
42013|NCT02339155|B2|Baseline|AVA+Raxibacumab|Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
42014|NCT02339155|B1|Baseline|AVA Alone|Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29
42015|NCT02339155|P2|Participant Flow|AVA+Raxibacumab|Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29. with the first AVA dose administered immediately after completion of a single 40 milligram/kilogram (mg/kg) intravenous (IV) infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
42016|NCT02339155|P1|Participant Flow|AVA Alone|Participants administered Anthrax vaccine adsorbed (AVA) subcutaneous (SC) 0.5 milliliter (mL) on Days 1, 15 and 29
42017|NCT02339155|O2|Outcome|AVA+Raxibacumab|Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
42018|NCT02339155|O1|Outcome|AVA Alone|Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29
42121|NCT02337959|B1|Baseline|Predicate & Investigational - GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
42019|NCT02339155|O2|Outcome|AVA+Raxibacumab|Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
42020|NCT02339155|O1|Outcome|AVA Alone|Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29
42021|NCT02339155|O2|Outcome|AVA+Raxibacumab|Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
42022|NCT02339155|O1|Outcome|AVA Alone|Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29
42023|NCT02339155|O2|Outcome|AVA+Raxibacumab|Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
42024|NCT02339155|O1|Outcome|AVA Alone|Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29
42025|NCT02339155|O2|Outcome|AVA+Raxibacumab|Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
42026|NCT02339155|O1|Outcome|AVA Alone|Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29
42027|NCT02339155|O2|Outcome|AVA+Raxibacumab|Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
42028|NCT02339155|O1|Outcome|AVA Alone|Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29
42029|NCT02339155|O2|Outcome|AVA+Raxibacumab|Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29. with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
42030|NCT02339155|O1|Outcome|AVA Alone|Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29
42031|NCT02339155|O2|Outcome|AVA+Raxibacumab|Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
42032|NCT02339155|O1|Outcome|AVA Alone|Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29
42033|NCT02339155|O2|Outcome|AVA+Raxibacumab|Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
42034|NCT02339155|O1|Outcome|AVA Alone|Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29
42035|NCT02339155|O2|Outcome|AVA+Raxibacumab|Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
42036|NCT02339155|O1|Outcome|AVA Alone|Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29
42037|NCT02339155|O2|Outcome|AVA+Raxibacumab|Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
42038|NCT02339155|O1|Outcome|AVA Alone|Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29
42039|NCT02339155|E2|Reported Event|AVA + Raxibacumab|Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
42040|NCT02339155|E1|Reported Event|AVA Alone|Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29
42041|NCT02339038|B1|Baseline|Standard of Care|Standard of care treatment using ledipasvir 90mg-sofosbuvir 400mg by mouth daily for 2, 3, or 6 months
42042|NCT02339038|P1|Participant Flow|Standard of Care|Standard of care treatment using ledipasvir 90mg-sofosbuvir 400mg by mouth daily for 2, 3, or 6 months
42043|NCT02339038|O1|Outcome|Standard of Care|Standard of care treatment using ledipasvir 90mg-sofosbuvir 400mg by mouth daily for 2, 3, or 6 months
42044|NCT02339038|E1|Reported Event|Standard of Care|Standard of care treatment using ledipasvir 90mg-sofosbuvir 400mg by mouth daily for 2, 3, or 6 months
42045|NCT02338843|B3|Baseline|Total|Total of all reporting groups
42046|NCT02338843|B2|Baseline|Placebo (0.9% Sodium Chloride Solution)|"Placebo arm~Placebo: PBO"
42047|NCT02338843|B1|Baseline|LJPC-501 (Angiotensin II)|"Treatment arm~LJPC-501: Treatment arm"
42048|NCT02338843|P2|Participant Flow|Placebo (0.9% Sodium Chloride Solution)|Placebo arm Volume matched saline administered via intravenous infusion
42049|NCT02338843|P1|Participant Flow|LJPC-501 (Angiotensin II)|Treatment arm Injection for Intravenous Infusion
42050|NCT02338843|O2|Outcome|Placebo (0.9% Sodium Chloride Solution)|"Placebo arm~Placebo: PBO"
42051|NCT02338843|O1|Outcome|LJPC-501 (Angiotensin II)|"Treatment arm~LJPC-501: Treatment arm"
42052|NCT02338843|E2|Reported Event|Placebo (0.9% Sodium Chloride Solution)|"Placebo arm~Placebo: PBO"
67799|NCT02153489|O2|Outcome|Placebo|Placebo BID
42054|NCT02338713|B1|Baseline|Noncarbonated Water+Calcichew D3|Noncarbonated water 200 milliliter (mL), orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period) followed by Calcichew D3 500 milligram (mg)/1000 international units (IU) (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period) of 6 days treatment period.
42055|NCT02338713|P1|Participant Flow|Noncarbonated Water+Calcichew D3|Noncarbonated water 200 milliliter (mL), orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period) followed by Calcichew D3 500 milligram (mg)/1000 international units (IU) (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period) of 6 days treatment period.
42056|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
42057|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
42058|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
42059|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
42060|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
42061|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
42062|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
42063|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
42064|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
42065|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
42066|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
42067|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
42068|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
42069|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
42070|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
42071|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
42072|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
42073|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
42074|NCT02338713|E2|Reported Event|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
42075|NCT02338713|E1|Reported Event|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
42076|NCT02338492|B1|Baseline|Photodynamic Bone Stabilization System (PBSS)|"The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone~IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus"
42077|NCT02338492|P1|Participant Flow|Photodynamic Bone Stabilization System (PBSS)|"The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone~IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus"
42078|NCT02338492|O1|Outcome|Photodynamic Bone Stabilization System (PBSS)|"The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone~IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus"
42079|NCT02338492|O1|Outcome|Photodynamic Bone Stabilization System (PBSS)|"The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone~IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus"
42080|NCT02338492|O1|Outcome|Photodynamic Bone Stabilization System (PBSS)|"The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone~IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus"
42123|NCT02337959|P2|Participant Flow|Predicate & Investigational - CsI|Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
67800|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
42081|NCT02338492|O1|Outcome|Photodynamic Bone Stabilization System (PBSS)|"The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone~IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus"
42082|NCT02338492|O1|Outcome|Photodynamic Bone Stabilization System (PBSS)|"The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone~IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus"
42083|NCT02338492|O1|Outcome|Photodynamic Bone Stabilization System (PBSS)|"The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone~IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus"
42084|NCT02338492|O1|Outcome|Photodynamic Bone Stabilization System (PBSS)|"The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone~IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus"
42085|NCT02338492|O1|Outcome|Photodynamic Bone Stabilization System (PBSS)|"The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone~IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus"
42086|NCT02338492|O1|Outcome|Photodynamic Bone Stabilization System (PBSS)|"The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone~IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus"
42087|NCT02338492|O1|Outcome|Photodynamic Bone Stabilization System (PBSS)|"The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone~IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus"
42088|NCT02338492|O1|Outcome|Photodynamic Bone Stabilization System (PBSS)|"The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone~IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus"
42089|NCT02338492|E1|Reported Event|Photodynamic Bone Stabilization System (PBSS)|"The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone~IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus"
42090|NCT02338336|B3|Baseline|Total|Total of all reporting groups
42091|NCT02338336|B2|Baseline|Nowarta110|All combined Nowarta110 doses
42092|NCT02338336|B1|Baseline|Placebo|Matching Placebo
42093|NCT02338336|P4|Participant Flow|Nowarta110 10 Drops|Nowarta110 10 drops administered topically
42094|NCT02338336|P3|Participant Flow|Nowarta110 6 Drops|Nowarta110 6 drops administered topically
42095|NCT02338336|P2|Participant Flow|Norwarta110 3 Drops|Nowarta110 3 drops administered topically
42096|NCT02338336|P1|Participant Flow|Placebo|Matching Placebo
42097|NCT02338336|O2|Outcome|TREATMENT|Nowarta110
42098|NCT02338336|O1|Outcome|Placebo|Matching Placebo
42099|NCT02338336|O2|Outcome|TREATMENT|Nowarta110
42100|NCT02338336|O1|Outcome|Placebo|Matching Placebo
42101|NCT02338336|E2|Reported Event|Nowarta110|All combined Nowarta110 doses
42102|NCT02338336|E1|Reported Event|Placebo|Matching Placebo
42103|NCT02338076|B1|Baseline|Interventional Arm|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
42104|NCT02338076|P1|Participant Flow|Interventional Arm|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
42105|NCT02338076|O3|Outcome|Control Arm/Normal Skin|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
42122|NCT02337959|P3|Participant Flow|Predicate & Investigational - Cadavers GOS & CsI|Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using the both the GoS and the CsI investigational detector.
67801|NCT02153489|O2|Outcome|Placebo|Placebo BID
42106|NCT02338076|O2|Outcome|Arm With Occlusion Only (Without Petrolatum)|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
42107|NCT02338076|O1|Outcome|Interventional Arm With Petrolatum|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
42108|NCT02338076|O3|Outcome|Control Arm/Normal Skin|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
42109|NCT02338076|O2|Outcome|Arm With Occlusion Only (Without Petrolatum)|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
42110|NCT02338076|O1|Outcome|Interventional Arm With Petrolatum|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
42111|NCT02338076|O3|Outcome|Control Arm/Normal Skin|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
42112|NCT02338076|O2|Outcome|Arm With Occlusion Only (Without Petrolatum)|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
42113|NCT02338076|O1|Outcome|Interventional Arm With Petrolatum|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
42114|NCT02338076|O3|Outcome|Control Arm/Normal Skin|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
42115|NCT02338076|O2|Outcome|Arm With Occlusion Only (Without Petrolatum)|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
42116|NCT02338076|O1|Outcome|Interventional Arm With Petrolatum|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
42117|NCT02338076|E1|Reported Event|Interventional Arm|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
42118|NCT02337959|B4|Baseline|Total|Total of all reporting groups
42119|NCT02337959|B3|Baseline|Predicate & Investigational-Cadavers GOS & CsI|Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using the both the GoS and the CsI investigational detector.
42120|NCT02337959|B2|Baseline|Predicate & Investigational - CsI|Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
42124|NCT02337959|P1|Participant Flow|Predicate & Investigational - GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
42125|NCT02337959|O1|Outcome|Image Pair Preference|Preference for predicate detector DRX-1 image versus preference for investigational DRX-Plus 3543/C (GOS & CsI) and vice versa.
42126|NCT02337959|O2|Outcome|Investigational|DRX Plus 3543/C (GOS & CsI) Detectors, Cadavers & Live Subjects
42127|NCT02337959|O1|Outcome|Predicate|DRX-1 Detector, Cadavers & Live Subjects
42128|NCT02337959|E3|Reported Event|Predicate & Invest.-Cadavers GOS & CsI|Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector.
42129|NCT02337959|E2|Reported Event|Predicate & Invest.-CsI|Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
42130|NCT02337959|E1|Reported Event|Predicate & Invest.-GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
42131|NCT02337491|B3|Baseline|Total|Total of all reporting groups
42132|NCT02337491|B2|Baseline|Cohort B: Pembrolizumab|"Pembrolizumab: 200 mg administered intravenously on days 1 and 22 of each 42 day cycle~Participants were treated until disease progression or unacceptable toxicity up to 16 cycles."
42133|NCT02337491|B1|Baseline|Cohort A: Pembrolizumab + Bevacizumab|"Pembrolizumab: 200 mg administered intravenously on days 1 and 22 of each 42 day cycle~Bevacizumab: 10 mg/kg administered Intravenously on days 1, 15 and 29 of each 42 day cycle~Participants were treated until disease progression or unacceptable toxicity up to 16 cycles."
42134|NCT02337491|P2|Participant Flow|Cohort B: Pembrolizumab|"Pembrolizumab: 200 mg administered intravenously on days 1 and 22 of each 42 day cycle~Participants were treated until disease progression or unacceptable toxicity up to 16 cycles."
42135|NCT02337491|P1|Participant Flow|Cohort A: Pembrolizumab + Bevacizumab|"Pembrolizumab: 200 mg administered intravenously on days 1 and 22 of each 42 day cycle~Bevacizumab: 10 mg/kg administered Intravenously on days 1, 15 and 29 of each 42 day cycle~Participants were treated until disease progression or unacceptable toxicity up to 16 cycles."
42136|NCT02337491|O2|Outcome|Cohort B: Pembrolizumab|"Pembrolizumab: 200 mg administered intravenously on days 1 and 22 of each 42 day cycle~Participants were treated until disease progression or unacceptable toxicity up to 16 cycles."
42137|NCT02337491|O1|Outcome|Cohort A: Pembrolizumab + Bevacizumab|"Pembrolizumab: 200 mg administered intravenously on days 1 and 22 of each 42 day cycle~Bevacizumab: 10 mg/kg administered Intravenously on days 1, 15 and 29 of each 42 day cycle~Participants were treated until disease progression or unacceptable toxicity up to 16 cycles."
42138|NCT02337491|O2|Outcome|Cohort B: Pembrolizumab|"Pembrolizumab: 200 mg administered intravenously on days 1 and 22 of each 42 day cycle~Participants were treated until disease progression or unacceptable toxicity up to 16 cycles."
42139|NCT02337491|O1|Outcome|Cohort A: Pembrolizumab + Bevacizumab|"Pembrolizumab: 200 mg administered intravenously on days 1 and 22 of each 42 day cycle~Bevacizumab: 10 mg/kg administered Intravenously on days 1, 15 and 29 of each 42 day cycle~Participants were treated until disease progression or unacceptable toxicity up to 16 cycles."
42140|NCT02337491|O2|Outcome|Cohort B: Pembrolizumab|"Pembrolizumab: 200 mg administered intravenously on days 1 and 22 of each 42 day cycle~Participants were treated until disease progression or unacceptable toxicity up to 16 cycles."
42141|NCT02337491|O1|Outcome|Cohort A: Pembrolizumab + Bevacizumab|"Pembrolizumab: 200 mg administered intravenously on days 1 and 22 of each 42 day cycle~Bevacizumab: 10 mg/kg administered Intravenously on days 1, 15 and 29 of each 42 day cycle~Participants were treated until disease progression or unacceptable toxicity up to 16 cycles."
42142|NCT02337491|O2|Outcome|Cohort B: Pembrolizumab|"Pembrolizumab: 200 mg administered intravenously on days 1 and 22 of each 42 day cycle~Participants were treated until disease progression or unacceptable toxicity up to 16 cycles."
42143|NCT02337491|O1|Outcome|Cohort A: Pembrolizumab + Bevacizumab|"Pembrolizumab: 200 mg administered intravenously on days 1 and 22 of each 42 day cycle~Bevacizumab: 10 mg/kg administered Intravenously on days 1, 15 and 29 of each 42 day cycle~Participants were treated until disease progression or unacceptable toxicity up to 16 cycles."
42144|NCT02337491|O1|Outcome|Cohort A Safety Lead-In: Pembrolizumab (DL 0) + Bevacizumab|"Pembrolizumab (Dose Level 0): 200 mg administered intravenously on days 1 and 22 of each 42 day cycle~Bevacizumab: 10 mg/kg administered Intravenously on days 1, 15 and 29 of each 42 day cycle~Participants were treated until disease progression or unacceptable toxicity up to 16 cycles."
42145|NCT02337491|O1|Outcome|Cohort A Safety Lead-In: Pembrolizumab (DL 0) + Bevacizumab|"Pembrolizumab (Dose Level 0): 200 mg administered intravenously on days 1 and 22 of each 42 day cycle~Bevacizumab: 10 mg/kg administered Intravenously on days 1, 15 and 29 of each 42 day cycle~Participants were treated until disease progression or unacceptable toxicity up to 16 cycles."
42146|NCT02337491|E2|Reported Event|Cohort B: Pembrolizumab|"Pembrolizumab (Dose Level 0): 200 mg administered intravenously on days 1 and 22 of each 42 day cycle~Participants were treated until disease progression or unacceptable toxicity up to 16 cycles."
42147|NCT02337491|E1|Reported Event|Cohort A: Pembrolizumab + Bevacizumab|"Pembrolizumab: 200 mg administered intravenously on days 1 and 22 of each 42 day cycle~Bevacizumab: 10 mg/kg administered Intravenously on days 1, 15 and 29 of each 42 day cycle~Participants were treated until disease progression or unacceptable toxicity up to 16 cycles."
42148|NCT02337062|B3|Baseline|Total|Total of all reporting groups
42149|NCT02337062|B2|Baseline|Placebo + Standard Anti-emetic|"Single dose of IV placebo~Placebo"
42150|NCT02337062|B1|Baseline|APD421 + Standard Anti-emetic|"Single dose of IV APD421~APD421"
42151|NCT02337062|P2|Participant Flow|Placebo + Standard Anti-emetic|Matching Placebo administered as a single, slow push, IV push over one minute at the time of induction anaesthesia given in combination with standard anti-emetic
42152|NCT02337062|P1|Participant Flow|APD421 + Standard Anti-emetic|APD421 (amisulpride) at 5 mg administered as a single, slow, intravenous (IV) push over one minute at the time of induction of anaesthesia; given in combination with standard anti-emetic.
42153|NCT02337062|O2|Outcome|Placebo + Standard Anti-emetic|"Single dose of IV placebo~Placebo"
42154|NCT02337062|O1|Outcome|APD421 + Standard Anti-emetic|"Single dose of IV APD421~APD421"
42155|NCT02337062|E2|Reported Event|Placebo + Standard Anti-emetic|"Single dose of IV placebo~Placebo"
42158|NCT02336958|B2|Baseline|Saline|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage.~pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration."
42159|NCT02336958|B1|Baseline|Ropivacaine|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage."
42160|NCT02336958|P2|Participant Flow|Saline|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage.~pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration."
42161|NCT02336958|P1|Participant Flow|Ropivacaine|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage."
42162|NCT02336958|O2|Outcome|Saline|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage.~pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration."
42163|NCT02336958|O1|Outcome|Ropivacaine|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage."
42164|NCT02336958|O2|Outcome|Saline|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage.~pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration."
42165|NCT02336958|O1|Outcome|Ropivacaine|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage."
42166|NCT02336958|E2|Reported Event|Saline|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage.~pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration."
42167|NCT02336958|E1|Reported Event|Ropivacaine|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage."
42168|NCT02336763|B1|Baseline|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
42169|NCT02336763|P1|Participant Flow|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
42170|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
42171|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
42172|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
42173|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
42454|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
67802|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
42174|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
42175|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
42176|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
42177|NCT02336763|E1|Reported Event|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
42178|NCT02336607|B5|Baseline|Total|Total of all reporting groups
42179|NCT02336607|B4|Baseline|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
42180|NCT02336607|B3|Baseline|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
42181|NCT02336607|B2|Baseline|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
42182|NCT02336607|B1|Baseline|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
42183|NCT02336607|P4|Participant Flow|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
42184|NCT02336607|P3|Participant Flow|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
42185|NCT02336607|P2|Participant Flow|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
42186|NCT02336607|P1|Participant Flow|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
42187|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
42188|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
42189|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
42190|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
42191|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
42192|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
42455|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
67803|NCT02153489|O2|Outcome|Placebo|Placebo BID
42193|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
42194|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
42195|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
42196|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
42197|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
42198|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
42199|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
42200|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
42201|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
42202|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
42203|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
42204|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
42205|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
42206|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
42207|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
42208|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
42209|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
42456|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
67804|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
42210|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
42211|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
42212|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
42213|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
42214|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
42215|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
42216|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
42217|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
42218|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
42219|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
42220|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
42221|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
42222|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
42223|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
42224|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
42225|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
42226|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
42227|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
42228|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
42229|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
42230|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
42231|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
42232|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
42233|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
42234|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
42235|NCT02336607|E4|Reported Event|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
42236|NCT02336607|E3|Reported Event|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
42237|NCT02336607|E2|Reported Event|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
42238|NCT02336607|E1|Reported Event|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
42239|NCT02336594|B5|Baseline|Total|Total of all reporting groups
42240|NCT02336594|B4|Baseline|Sequence BADC|10 mg tablet qd fasted, 2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fed high-fat, 10 mg tablet qd fed low-fat
42241|NCT02336594|B3|Baseline|Sequence ABDC|2.5 x 4 mg tablets qd fasted, 10 mg tablet qd fasted, 10 mg tablet qd fed high-fat, 10 mg tablet qd fed low-fat
42242|NCT02336594|B2|Baseline|Sequence BACD|10 mg tablet qd fasted, 2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fed low-fat, 10 mg tablet qd fed high-fat
42243|NCT02336594|B1|Baseline|Sequence ABCD|2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fasted, 10 mg tablet qd fed low-fat, 10 mg tablet qd fed high-fat.
42244|NCT02336594|P4|Participant Flow|Sequence BADC|Day 1 (Treatment B): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fasted state; Day 5 (Treatment A): 10 mg dose of RDEA3170, administered as 4 × 2.5 mg ER tablets, in the fasted state; Day 9 (Treatment D): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (high-fat, high-calorie meal); Day 13 (Treatment C): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (low-fat, high-calorie meal).
42245|NCT02336594|P3|Participant Flow|Sequence ABDC|Day 1 (Treatment A): 10 mg dose of RDEA3170, administered as 4 × 2.5 mg ER tablets, in the fasted state; Day 5 (Treatment B): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fasted state; Day 9 (Treatment D): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (high-fat, high-calorie meal); Day 13 (Treatment C): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (low-fat, high-calorie meal).
42246|NCT02336594|P2|Participant Flow|Sequence BACD|Day 1 (Treatment B): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fasted state; Day 5 (Treatment A): 10 mg dose of RDEA3170, administered as 4 × 2.5 mg ER tablets, in the fasted state; Day 9 (Treatment C): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (low-fat, high-calorie meal); Day 13 (Treatment D): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (high-fat, high-calorie meal).
42457|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
42499|NCT02334982|P3|Participant Flow|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
42247|NCT02336594|P1|Participant Flow|Sequence ABCD|Day 1 (Treatment A): 10 mg dose of RDEA3170, administered as 4 × 2.5 mg ER tablets, in the fasted state; Day 5 (Treatment B): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fasted state; Day 9 (Treatment C): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (low-fat, high-calorie meal); Day 13 (Treatment D): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (high-fat, high-calorie meal).
42248|NCT02336594|O4|Outcome|Treatment D|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).
42249|NCT02336594|O3|Outcome|Treatment C|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).
42250|NCT02336594|O2|Outcome|Treatment B|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
42251|NCT02336594|O1|Outcome|Treatment A|10 mg dose of RDEA3170, administered as 4 × 2.5 mg tablets, in the fasted state.
42252|NCT02336594|O4|Outcome|Treatment D|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).
42253|NCT02336594|O3|Outcome|Treatment C|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).
42254|NCT02336594|O2|Outcome|Treatment B|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
42255|NCT02336594|O1|Outcome|Treatment A|10 mg dose of RDEA3170, administered as 4 × 2.5 mg tablets, in the fasted state.
42256|NCT02336594|O2|Outcome|Treatment C|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).
42257|NCT02336594|O1|Outcome|Treatment B|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
42258|NCT02336594|O2|Outcome|Treatment C|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).
42259|NCT02336594|O1|Outcome|Treatment B|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
42260|NCT02336594|O2|Outcome|Treatment C|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).
42261|NCT02336594|O1|Outcome|Treatment B|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
42262|NCT02336594|O2|Outcome|Treatment D|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).
42263|NCT02336594|O1|Outcome|Treatment B|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
42264|NCT02336594|O2|Outcome|Treatment D|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).
42265|NCT02336594|O1|Outcome|Treatment B|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
42266|NCT02336594|O2|Outcome|Treatment D|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).
42267|NCT02336594|O1|Outcome|Treatment B|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
42268|NCT02336594|O4|Outcome|Treatment D|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).
42269|NCT02336594|O3|Outcome|Treatment C|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).
42270|NCT02336594|O2|Outcome|Treatment B|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
42271|NCT02336594|O1|Outcome|Treatment A|10 mg dose of RDEA3170, administered as 4 × 2.5 mg tablets, in the fasted state.
42272|NCT02336594|O2|Outcome|Treatment B|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
42273|NCT02336594|O1|Outcome|Treatment A|10 mg dose of RDEA3170, administered as 4 × 2.5 mg tablets, in the fasted state.
42274|NCT02336594|O2|Outcome|Treatment B|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
42275|NCT02336594|O1|Outcome|Treatment A|10 mg dose of RDEA3170, administered as 4 × 2.5 mg tablets, in the fasted state.
42276|NCT02336594|O4|Outcome|Treatment D|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).
42277|NCT02336594|O3|Outcome|Treatment C|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).
42278|NCT02336594|O2|Outcome|Treatment B|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
42279|NCT02336594|O1|Outcome|Treatment A|10 mg dose of RDEA3170, administered as 4 × 2.5 mg tablets, in the fasted state.
42280|NCT02336594|O2|Outcome|Treatment B|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
42281|NCT02336594|O1|Outcome|Treatment A|10 mg dose of RDEA3170, administered as 4 × 2.5 mg tablets, in the fasted state.
42282|NCT02336594|E4|Reported Event|Treatment D|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).
42283|NCT02336594|E3|Reported Event|Treatment C|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).
42284|NCT02336594|E2|Reported Event|Treatment B|10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.
42285|NCT02336594|E1|Reported Event|Treatment A|10 mg dose of RDEA3170, administered as 4 × 2.5 mg tablets, in the fasted state.
42286|NCT02336438|B1|Baseline|Baseline Phase (Control), Crossover to Treatment (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Glucomannan:~For the next five days subjects will take the following amounts of Glucomannan soluble fiber (provided by the investigator) three times a day with meals.~Breakfast: Take 5 grams (1 tsp) of Glucomannan. Lunch: Take 5 grams (1 tsp) of Glucomannan Dinner: Take 5 grams (1 tsp) of Glucomannan.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
42352|NCT02336178|B1|Baseline|BeneFIX|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42287|NCT02336438|P1|Participant Flow|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro® Continuous Glucose Monitor (CGM) device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.~Glucomannan:~iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
42288|NCT02336438|O1|Outcome|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.~Glucomannan:~iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
42289|NCT02336438|O1|Outcome|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.~Glucomannan:~iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
42290|NCT02336438|O1|Outcome|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.~Glucomannan:~iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
42291|NCT02336438|O1|Outcome|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.~Glucomannan:~iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
42292|NCT02336438|O1|Outcome|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.~Glucomannan:~iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
42293|NCT02336438|O1|Outcome|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.~Glucomannan:~iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
42353|NCT02336178|P1|Participant Flow|BeneFIX|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42458|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
42294|NCT02336438|E1|Reported Event|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Glucomannan:~For the next five days subjects will take the following amounts of Glucomannan soluble fiber (provided by the investigator) three times a day with meals.~Breakfast: Take 5 grams (1 tsp) of Glucomannan. Lunch: Take 5 grams (1 tsp) of Glucomannan Dinner: Take 5 grams (1 tsp) of Glucomannan.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
42295|NCT02336425|B5|Baseline|Total|Total of all reporting groups
42296|NCT02336425|B4|Baseline|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
42297|NCT02336425|B3|Baseline|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
42298|NCT02336425|B2|Baseline|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
42299|NCT02336425|B1|Baseline|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
42300|NCT02336425|P4|Participant Flow|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
42301|NCT02336425|P3|Participant Flow|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
42302|NCT02336425|P2|Participant Flow|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
42303|NCT02336425|P1|Participant Flow|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
42304|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
42305|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
42306|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
42307|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
42308|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
42309|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
42310|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
42311|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
42312|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
42313|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
42314|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
42315|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
42316|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
42317|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
42318|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
42319|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
42320|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
42321|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
42322|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
42323|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
42324|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
42325|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
42326|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
42327|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
42328|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
42329|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
42330|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
42331|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
42332|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
42333|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
42334|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
42335|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
42336|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
42337|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
42338|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
42339|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
42340|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
42341|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
42342|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
42343|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
42344|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
42345|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
42346|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
42347|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
42348|NCT02336425|E4|Reported Event|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
42349|NCT02336425|E3|Reported Event|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
42350|NCT02336425|E2|Reported Event|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
42351|NCT02336425|E1|Reported Event|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
42453|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
67805|NCT02153489|O2|Outcome|Placebo|Placebo BID
42354|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
42355|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42356|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
42357|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42358|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42359|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42360|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
42361|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42362|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
42363|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42364|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42365|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42366|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
42367|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42368|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
42369|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42370|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42371|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42372|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
42373|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42374|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
42375|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42376|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42377|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42378|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
42379|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42380|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
42381|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42382|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42383|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42384|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
42385|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42386|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
42387|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42388|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42389|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42390|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
42391|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42392|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received prophylaxis treatment with BeneFIX according to usual care in China and in accord with the China BeneFIX Package Insert. The treatment duration was 6 months (±7 days) or 50 Exposure Days (±5 EDs) whichever occurred first. On-demand treatment was given as needed.
42393|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42394|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42395|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42396|NCT02336178|O5|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
42397|NCT02336178|O4|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42398|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42399|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42400|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42401|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
42402|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42403|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
42404|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42405|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42406|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42407|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
42459|NCT02335710|E2|Reported Event|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
42408|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42409|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
42410|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42411|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42412|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42413|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
42414|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42415|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
42416|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42417|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42418|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42419|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
42420|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42421|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
42422|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42423|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42424|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42425|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
42426|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42427|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
42428|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42429|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42430|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42431|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
42432|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42433|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
42434|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42435|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42436|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42437|NCT02336178|E1|Reported Event|BeneFIX|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
42438|NCT02335710|B3|Baseline|Total|Total of all reporting groups
42439|NCT02335710|B2|Baseline|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
42440|NCT02335710|B1|Baseline|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II bi-cruciate stabilizing (BCS) total knee arthroplasty (TKA) implanted by Dr. Harold Cates~Journey II BCS TKA"
42441|NCT02335710|P2|Participant Flow|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
42442|NCT02335710|P1|Participant Flow|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
42443|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
42444|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
42445|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
42446|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
42447|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
42448|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
42449|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
42450|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
42451|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
42452|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
42460|NCT02335710|E1|Reported Event|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
42461|NCT02335502|B1|Baseline|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
42462|NCT02335502|P1|Participant Flow|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
42463|NCT02335502|O1|Outcome|Subjected Treated With the Permanent Implantable Axium System|All subjects treated with the Axium implantable neurostimulator
42464|NCT02335502|O1|Outcome|Subjected Treated With the Permanent Implantable Axium System|All subjects treated with the Axium implantable neurostimulator
42465|NCT02335502|E1|Reported Event|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
42466|NCT02335489|B1|Baseline|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
42467|NCT02335489|P1|Participant Flow|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator for the Management of Chronic Neuropathic Pain of the Foot and/or Lower Leg
42468|NCT02335489|O1|Outcome|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
42469|NCT02335489|E1|Reported Event|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
42470|NCT02335346|B1|Baseline|Duloxetine|Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
42471|NCT02335346|P1|Participant Flow|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
42472|NCT02335346|O1|Outcome|Duloxetine|Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
42473|NCT02335346|O1|Outcome|Duloxetine|Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
42474|NCT02335346|O1|Outcome|Duloxetine|Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
42475|NCT02335346|O1|Outcome|Duloxetine|Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
42476|NCT02335346|O1|Outcome|Duloxetine|Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
42477|NCT02335346|O1|Outcome|Duloxetine|Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
42478|NCT02335346|O1|Outcome|Duloxetine|Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
42479|NCT02335346|O1|Outcome|Duloxetine|Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
42480|NCT02335346|O1|Outcome|Duloxetine|Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
42481|NCT02335346|E1|Reported Event|Duloxetine|Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
42482|NCT02335216|B1|Baseline|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
42483|NCT02335216|P1|Participant Flow|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
42484|NCT02335216|O1|Outcome|Subjected Treated With the Permanent Implantable Axium System|All subjects treated with the Axium implantable neurostimulator
42485|NCT02335216|O1|Outcome|Subjected Treated With the Permanent Implantable Axium System|All subjects treated with the Axium implantable neurostimulator
42486|NCT02335216|E1|Reported Event|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
42487|NCT02334982|B8|Baseline|Total|Total of all reporting groups
42488|NCT02334982|B7|Baseline|Cohorts 1-6: Placebo|TAK-137 placebo-matching tablets, orally, once on Day 1.
42489|NCT02334982|B6|Baseline|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, once on Day 1.
42490|NCT02334982|B5|Baseline|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, once on Day 1.
42491|NCT02334982|B4|Baseline|Cohort 4: TAK-137 5 mg Food Effect|TAK-137 5 mg, tablets, orally, under fasted conditions, once on Day 1 of Period 1, followed by 14 days of follow-up, followed by TAK-137 5 mg, tablets, orally, under fed conditions, once on Day 1 of Period 2.
42492|NCT02334982|B3|Baseline|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
42493|NCT02334982|B2|Baseline|Cohort 2: TAK-137 5 mg|TAK-137 5 mg, tablets, orally, once on Day 1.
42494|NCT02334982|B1|Baseline|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, once on Day 1.
42495|NCT02334982|P7|Participant Flow|Cohorts 1-6: Placebo|TAK-137 placebo-matching tablets, orally, once on Day 1.
42496|NCT02334982|P6|Participant Flow|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, once on Day 1.
42497|NCT02334982|P5|Participant Flow|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, once on Day 1.
42498|NCT02334982|P4|Participant Flow|Cohort 4: TAK-137 5 mg Food Effect|TAK-137 5 mg, tablets, orally, under fasted conditions, once on Day 1 of Period 1, followed by 14 days of follow-up, followed by TAK-137 5 mg, tablets, orally, under fed conditions, once on Day 1 of Period 2.
42500|NCT02334982|P2|Participant Flow|Cohort 2: TAK-137 5 mg|TAK-137 5 mg, tablets, orally, once on Day 1.
42501|NCT02334982|P1|Participant Flow|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, once on Day 1.
42502|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
42503|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
42504|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
42505|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
42506|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
42507|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
42508|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
42509|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
42510|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
42511|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
42512|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
42513|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
42514|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
42515|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
42516|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
42517|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
42518|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
42519|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
42520|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
42521|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
42522|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
42523|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
42524|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
42525|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
42526|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
42527|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
42528|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
42529|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
42530|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
42531|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
42532|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
42533|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
42534|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
42535|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
42536|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
42537|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
42538|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
42539|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
42540|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
42541|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
42542|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
42543|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
42544|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
42545|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
42546|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
42547|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
42548|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
42549|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
42550|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
42551|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
42552|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
42553|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
42554|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
42555|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
44371|NCT02320695|O5|Outcome|Original Ointment|Neosporin® Original Ointment (0.3 cc)
42556|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
42557|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
42558|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
42559|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
42560|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
42561|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
42562|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
42563|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
42564|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
42565|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
42566|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
42567|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
42568|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
42569|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
42570|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
42571|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
42572|NCT02334982|O8|Outcome|Placebo (Fed)|TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
42573|NCT02334982|O7|Outcome|TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
42574|NCT02334982|O6|Outcome|TAK-137 Placebo|TAK-137 placebo-matching tablets, orally, fasting, once on Day 1.
42575|NCT02334982|O5|Outcome|TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
42576|NCT02334982|O4|Outcome|TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
42577|NCT02334982|O3|Outcome|TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
42578|NCT02334982|O2|Outcome|TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
42579|NCT02334982|O1|Outcome|TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
42580|NCT02334982|O8|Outcome|Placebo (Fed)|TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
42581|NCT02334982|O7|Outcome|TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
42582|NCT02334982|O6|Outcome|Placebo Fasting|TAK-137 placebo-matching tablets, orally, fasting, once on Day 1.
42583|NCT02334982|O5|Outcome|TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
42584|NCT02334982|O4|Outcome|TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
42585|NCT02334982|O3|Outcome|TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
42586|NCT02334982|O2|Outcome|TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
42587|NCT02334982|O1|Outcome|TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
42588|NCT02334982|O8|Outcome|Placebo (Fed)|TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
42589|NCT02334982|O7|Outcome|TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
42590|NCT02334982|O6|Outcome|TAK-137 Placebo|TAK-137 placebo-matching tablets, orally, once on Day 1.
42591|NCT02334982|O5|Outcome|TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
42592|NCT02334982|O4|Outcome|TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
42593|NCT02334982|O3|Outcome|TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
42594|NCT02334982|O2|Outcome|TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
42595|NCT02334982|O1|Outcome|TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
42596|NCT02334982|E8|Reported Event|Placebo (Fed)|TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
42597|NCT02334982|E7|Reported Event|TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
42598|NCT02334982|E6|Reported Event|Placebo Fasting|TAK-137 placebo-matching tablets, orally, fasting, once on Day 1.
42599|NCT02334982|E5|Reported Event|TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
42600|NCT02334982|E4|Reported Event|TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
42601|NCT02334982|E3|Reported Event|TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
42602|NCT02334982|E2|Reported Event|TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
42603|NCT02334982|E1|Reported Event|TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
42604|NCT02334813|B3|Baseline|Total|Total of all reporting groups
42605|NCT02334813|B2|Baseline|Arm B: Pulsed Dexamethasone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm B patients subsequently receive six 21-day courses of pulsed dexamethasone (0.6 mg/kg/d, days 1-4).~Dexamethasone: 4-day pulses every 3 weeks"
42606|NCT02334813|B1|Baseline|Arm A: Daily Prednisone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm A prednisone is continued at 1 mg/kg/d for a second week. If platelets increase to ≥50/nl, its dose is reduced to <25 mg/d by week 14 and <7.5 mg/d by week 20 according to a step-wise reduction scheme provided in the protocol. In patients without response after 2 weeks of treatment, the prednisone dose is increased to 2 mg/kg/d for another 2 weeks, then tapered as described above.~Prednisone: Continuous daily therapy"
42607|NCT02334813|P2|Participant Flow|Arm B: Pulsed Dexamethasone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm B patients subsequently receive six 21-day courses of pulsed dexamethasone (0.6 mg/kg/d, days 1-4).~Dexamethasone: 4-day pulses every 3 weeks"
43472|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
42608|NCT02334813|P1|Participant Flow|Arm A: Daily Prednisone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm A prednisone is continued at 1 mg/kg/d for a second week. If platelets increase to ≥50/nl, its dose is reduced to <25 mg/d by week 14 and <7.5 mg/d by week 20 according to a step-wise reduction scheme provided in the protocol. In patients without response after 2 weeks of treatment, the prednisone dose is increased to 2 mg/kg/d for another 2 weeks, then tapered as described above.~Prednisone: Continuous daily therapy"
42609|NCT02334813|O2|Outcome|Arm B: Pulsed Dexamethasone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm B patients subsequently receive six 21-day courses of pulsed dexamethasone (0.6 mg/kg/d, days 1-4).~Dexamethasone: 4-day pulses every 3 weeks"
42610|NCT02334813|O1|Outcome|Arm A: Daily Prednisone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm A prednisone is continued at 1 mg/kg/d for a second week. If platelets increase to ≥50/nl, its dose is reduced to <25 mg/d by week 14 and <7.5 mg/d by week 20 according to a step-wise reduction scheme provided in the protocol. In patients without response after 2 weeks of treatment, the prednisone dose is increased to 2 mg/kg/d for another 2 weeks, then tapered as described above.~Prednisone: Continuous daily therapy"
42611|NCT02334813|E2|Reported Event|Arm B: Pulsed Dexamethasone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm B patients subsequently receive six 21-day courses of pulsed dexamethasone (0.6 mg/kg/d, days 1-4).~Dexamethasone: 4-day pulses every 3 weeks"
42612|NCT02334813|E1|Reported Event|Arm A: Daily Prednisone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm A prednisone is continued at 1 mg/kg/d for a second week. If platelets increase to ≥50/nl, its dose is reduced to <25 mg/d by week 14 and <7.5 mg/d by week 20 according to a step-wise reduction scheme provided in the protocol. In patients without response after 2 weeks of treatment, the prednisone dose is increased to 2 mg/kg/d for another 2 weeks, then tapered as described above.~Prednisone: Continuous daily therapy"
42613|NCT02334800|B5|Baseline|Total|Total of all reporting groups
42614|NCT02334800|B4|Baseline|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42615|NCT02334800|B3|Baseline|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42616|NCT02334800|B2|Baseline|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42617|NCT02334800|B1|Baseline|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42618|NCT02334800|P4|Participant Flow|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42619|NCT02334800|P3|Participant Flow|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42620|NCT02334800|P2|Participant Flow|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42621|NCT02334800|P1|Participant Flow|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42622|NCT02334800|O4|Outcome|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42623|NCT02334800|O3|Outcome|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42624|NCT02334800|O2|Outcome|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42625|NCT02334800|O1|Outcome|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42626|NCT02334800|O4|Outcome|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42820|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42627|NCT02334800|O3|Outcome|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42628|NCT02334800|O2|Outcome|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42629|NCT02334800|O1|Outcome|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42630|NCT02334800|O4|Outcome|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42631|NCT02334800|O3|Outcome|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42632|NCT02334800|O2|Outcome|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42633|NCT02334800|O1|Outcome|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42634|NCT02334800|O4|Outcome|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42635|NCT02334800|O3|Outcome|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42636|NCT02334800|O2|Outcome|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42637|NCT02334800|O1|Outcome|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42638|NCT02334800|O4|Outcome|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42639|NCT02334800|O3|Outcome|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42640|NCT02334800|O2|Outcome|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42641|NCT02334800|O1|Outcome|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42642|NCT02334800|O4|Outcome|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42643|NCT02334800|O3|Outcome|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42644|NCT02334800|O2|Outcome|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42645|NCT02334800|O1|Outcome|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42646|NCT02334800|O4|Outcome|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42647|NCT02334800|O3|Outcome|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42648|NCT02334800|O2|Outcome|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42649|NCT02334800|O1|Outcome|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42650|NCT02334800|O4|Outcome|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42651|NCT02334800|O3|Outcome|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42652|NCT02334800|O2|Outcome|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42653|NCT02334800|O1|Outcome|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42654|NCT02334800|O4|Outcome|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42655|NCT02334800|O3|Outcome|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42656|NCT02334800|O2|Outcome|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42657|NCT02334800|O1|Outcome|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42658|NCT02334800|O4|Outcome|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42659|NCT02334800|O3|Outcome|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42660|NCT02334800|O2|Outcome|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42661|NCT02334800|O1|Outcome|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42662|NCT02334800|O4|Outcome|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42663|NCT02334800|O3|Outcome|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42664|NCT02334800|O2|Outcome|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42665|NCT02334800|O1|Outcome|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42666|NCT02334800|O4|Outcome|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42667|NCT02334800|O3|Outcome|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42668|NCT02334800|O2|Outcome|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42669|NCT02334800|O1|Outcome|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42670|NCT02334800|O4|Outcome|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42671|NCT02334800|O3|Outcome|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42672|NCT02334800|O2|Outcome|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42673|NCT02334800|O1|Outcome|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42674|NCT02334800|O4|Outcome|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42675|NCT02334800|O3|Outcome|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42676|NCT02334800|O2|Outcome|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42677|NCT02334800|O1|Outcome|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42678|NCT02334800|O4|Outcome|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42679|NCT02334800|O3|Outcome|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42680|NCT02334800|O2|Outcome|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42681|NCT02334800|O1|Outcome|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42682|NCT02334800|O4|Outcome|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42683|NCT02334800|O3|Outcome|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42684|NCT02334800|O2|Outcome|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42685|NCT02334800|O1|Outcome|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42686|NCT02334800|O4|Outcome|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42687|NCT02334800|O3|Outcome|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42688|NCT02334800|O2|Outcome|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42689|NCT02334800|O1|Outcome|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42690|NCT02334800|O4|Outcome|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42691|NCT02334800|O3|Outcome|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42692|NCT02334800|O2|Outcome|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42693|NCT02334800|O1|Outcome|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42694|NCT02334800|O4|Outcome|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42695|NCT02334800|O3|Outcome|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42696|NCT02334800|O2|Outcome|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42697|NCT02334800|O1|Outcome|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42698|NCT02334800|O4|Outcome|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42699|NCT02334800|O3|Outcome|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42700|NCT02334800|O2|Outcome|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42701|NCT02334800|O1|Outcome|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42702|NCT02334800|O4|Outcome|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42703|NCT02334800|O3|Outcome|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42704|NCT02334800|O2|Outcome|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42705|NCT02334800|O1|Outcome|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42706|NCT02334800|E4|Reported Event|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42707|NCT02334800|E3|Reported Event|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42708|NCT02334800|E2|Reported Event|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42709|NCT02334800|E1|Reported Event|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
42710|NCT02334787|B5|Baseline|Total|Total of all reporting groups
42711|NCT02334787|B4|Baseline|Placebo|In a single administration period and the multiple administration period, same subjects were treated with assigned placebo ointment.
42712|NCT02334787|B3|Baseline|3% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 3% OPA-15406 ointment.
42713|NCT02334787|B2|Baseline|1% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 1% OPA-15406 ointment.
42714|NCT02334787|B1|Baseline|0.3% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment.
42715|NCT02334787|P4|Participant Flow|Placebo|In a single administration period and the multiple administration period, same subjects were treated with assigned placebo ointment.
42716|NCT02334787|P3|Participant Flow|3% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 3% OPA-15406 ointment.
42717|NCT02334787|P2|Participant Flow|1% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 1% OPA-15406 ointment.
42718|NCT02334787|P1|Participant Flow|0.3% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment.
42719|NCT02334787|O3|Outcome|3% OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 3％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
42720|NCT02334787|O2|Outcome|1 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 1％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
42721|NCT02334787|O1|Outcome|0.3 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 0.3％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
42722|NCT02334787|O3|Outcome|3% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 3% OPA-15406 ointment assessed until 48 hours postdose.
42723|NCT02334787|O2|Outcome|1% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 1% OPA-15406 ointment assessed until 48 hours postdose.
42724|NCT02334787|O1|Outcome|0.3% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned0.3％OPA-15406 ointment assessed until 48 hours postdose.
42725|NCT02334787|O3|Outcome|3% OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 3％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
42726|NCT02334787|O2|Outcome|1 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 1％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
42727|NCT02334787|O1|Outcome|0.3 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 0.3％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
42728|NCT02334787|O3|Outcome|3% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 3% OPA-15406 ointment assessed until 48 hours postdose.
42729|NCT02334787|O2|Outcome|1% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 1% OPA-15406 ointment assessed until 48 hours postdose.
42730|NCT02334787|O1|Outcome|0.3% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned0.3％OPA-15406 ointment assessed until 48 hours postdose.
42731|NCT02334787|E8|Reported Event|Placebo Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned placebo ointment twice daily for 14 days and assessed until 48 hours post dose.
42732|NCT02334787|E7|Reported Event|3 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 3 % OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
42733|NCT02334787|E6|Reported Event|1 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 1 % OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
42734|NCT02334787|E5|Reported Event|0.3 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 0.3 % OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
46548|NCT02305277|E4|Reported Event|BIA 9-1067 25 mg TBM|BIA 9-1067 25 mg TBM TBM - to-be-marketed
42735|NCT02334787|E4|Reported Event|Placebo in a Single Adminstaration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, same subjects were treated with assigned placebo ointment.
42736|NCT02334787|E3|Reported Event|3% OPA-15406 Ointment in a Single Administaration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, same subjects were treated with assigned 3% OPA-15406 ointment.
42737|NCT02334787|E2|Reported Event|1% OPA-15406 Ointment in a Single Administaration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single and administration period, same subjects were treated with assigned 1% OPA-15406 ointment.
42738|NCT02334787|E1|Reported Event|0.3 % OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment
42739|NCT02334527|B1|Baseline|Single Arm (Single Arm Trial)|"Palbociclib~Palbociclib: 125 mg capsule will be taken once per day orally and continuously for 3 weeks followed by 1 week off."
42740|NCT02334527|P1|Participant Flow|Palbociclib (Single Arm Trial)|"Palbociclib~Palbociclib: 125 mg capsule will be taken once per day orally and continuously for 3 weeks followed by 1 week off."
42741|NCT02334527|O2|Outcome|Grade >=3 Adverse Event|"Palbociclib~Palbociclib: 125 mg capsule will be taken once per day orally and continuously for 3 weeks followed by 1 week off"
42742|NCT02334527|O1|Outcome|Any Grade Adverse Events|"Palbociclib~Palbociclib: 125 mg capsule will be taken once per day orally and continuously for 3 weeks followed by 1 week off."
42743|NCT02334527|O1|Outcome|Palbociclib (Single Arm Trial)|"Palbociclib~Palbociclib: 125 mg capsule will be taken once per day orally and continuously for 3 weeks followed by 1 week off."
42744|NCT02334527|O1|Outcome|Palbociclib (Single Arm Trial)|"Palbociclib~Palbociclib: 125 mg capsule will be taken once per day orally and continuously for 3 weeks followed by 1 week off."
42745|NCT02334527|O1|Outcome|Palbociclib Single Arm Trial|"Palbociclib~Palbociclib: 125 mg capsule will be taken once per day orally and continuously for 3 weeks followed by 1 week off."
42746|NCT02334527|O1|Outcome|Single Arm (Single Arm Trial)|"Palbociclib~Palbociclib: 125 mg capsule will be taken once per day orally and continuously for 3 weeks followed by 1 week off."
42747|NCT02334527|E1|Reported Event|Single Arm (Single Arm Trial)|"Palbociclib~Palbociclib: 125 mg capsule will be taken once per day orally and continuously for 3 weeks followed by 1 week off."
42748|NCT02334267|B3|Baseline|Total|Total of all reporting groups
42749|NCT02334267|B2|Baseline|Group 2 Week 1 NaturaLyte and Week 2 GranuFlo|"Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using acid dialysate concentrations of GranuFlo for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments.~NaturaLyte: Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using GranuFlo, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments."
42750|NCT02334267|B1|Baseline|Group 1Week 1 GranuFlo and Week 2 NaturaLyte|"Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using acid dialysate concentrations of NaturaLyte for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments.~GranuFlow: Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using NaturaLyte, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments."
42751|NCT02334267|P2|Participant Flow|Group 2 Week 1 NaturaLyte and Week 2 GranuFlo|"Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using acid dialysate concentrations of GranuFlo for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments.~NaturaLyte: Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using GranuFlo, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments."
42752|NCT02334267|P1|Participant Flow|Group 1 Week 1 GranuFlo and Week 2 NaturaLyte|"Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using acid dialysate concentrations of NaturaLyte for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments.~GranuFlow: Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using NaturaLyte, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments."
42753|NCT02334267|O2|Outcome|NaturaLyte|The outcome measure was peridialytic venous blood acetate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate NaturaLyte
42754|NCT02334267|O1|Outcome|GranuFlo|The outcome measure was peridialytic venous blood acetate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate GranuFlo
42821|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42755|NCT02334267|O2|Outcome|NaturaLyte|The outcome measure was peridialytic arterialized blood acetate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate NaturaLyte
42756|NCT02334267|O1|Outcome|GranuFlo|The outcome measure was peridialytic arterialized blood acetate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate GranuFlo
42757|NCT02334267|O2|Outcome|NaturaLyte|The outcome measure was peridialytic venous blood bicarbonate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate NaturaLyte
42758|NCT02334267|O1|Outcome|GranuFlo|The outcome measure was peridialytic venous blood bicarbonate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate GranuFlo
42759|NCT02334267|O2|Outcome|NaturaLyte|The outcome measure was peridialytic arterialized blood bicarbonate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate NaturaLyte
42760|NCT02334267|O1|Outcome|GranuFlo|The outcome measure was peridialytic arterialized blood bicarbonate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate GranuFlo
42761|NCT02334267|E2|Reported Event|NaturaLyte|The safety reporting group included subjects who received one study related hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate NaturaLyte.
42762|NCT02334267|E1|Reported Event|GranuFlo|The safety reporting group included subjects who received one study related hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate GranuFlo.
42763|NCT02333045|B3|Baseline|Total|Total of all reporting groups
42764|NCT02333045|B2|Baseline|Maraviroc|Women randomized to receive 300mg of Maraviroc daily for 7 days.
42765|NCT02333045|B1|Baseline|Truvada|Women randomized to receive one tablet of Truvada (200mg emtricitabine/300mg tenofovir) daily for 7 days.
42766|NCT02333045|P2|Participant Flow|Maraviroc|Women randomized to receive 300mg of Maraviroc daily for 7 days.
42767|NCT02333045|P1|Participant Flow|Truvada|Women randomized to receive one tablet of Truvada (200mg emtricitabine/300mg tenofovir) daily for 7 days.
42768|NCT02333045|O2|Outcome|Maraviroc|Women randomized to receive 300mg of Maraviroc daily for 7 days.
42769|NCT02333045|O1|Outcome|Truvada|Women randomized to receive one tablet of Truvada (200mg emtricitabine/300mg tenofovir) daily for 7 days.
42770|NCT02333045|O2|Outcome|Maraviroc|Women randomized to receive 300mg of Maraviroc daily for 7 days.
42771|NCT02333045|O1|Outcome|Truvada|Women randomized to receive one tablet of Truvada (200mg emtricitabine/300mg tenofovir) daily for 7 days.
42772|NCT02333045|O2|Outcome|Maraviroc|Women randomized to receive 300mg of Maraviroc daily for 7 days.
42773|NCT02333045|O1|Outcome|Truvada|Women randomized to receive one tablet of Truvada (200mg emtricitabine/300mg tenofovir) daily for 7 days.
42774|NCT02333045|E2|Reported Event|Maraviroc|Women randomized to receive 300mg of Maraviroc 300 mg daily for 7 days.
42775|NCT02333045|E1|Reported Event|Truvada|Women randomized to receive on tablet of Truvada daily for 7 days.
42776|NCT02332902|B1|Baseline|Intervention|"This is a single arm intervention using Everolimus.~Everyone in the study will receive Everolimus at a starting dose of 10 mg daily and will be adjusted up or down by 2.5 mg at 2-week intervals to attain a trough concentration of 5-15 ng/mL."
42777|NCT02332902|P1|Participant Flow|Intervention|"This is a single arm intervention using Everolimus.~Everyone in the study will receive Everolimus at a starting dose of 10 mg daily and will be adjusted up or down by 2.5 mg at 2-week intervals to attain a trough concentration of 5-15 ng/mL."
42778|NCT02332902|O1|Outcome|Intervention|"This is a single arm intervention using Everolimus.~Everyone in the study will receive Everolimus at a starting dose of 10 mg daily and will be adjusted up or down by 2.5 mg at 2-week intervals to attain a trough concentration of 5-15 ng/mL."
42779|NCT02332902|O1|Outcome|Intervention|"This is a single arm intervention using Everolimus.~Everyone in the study will receive Everolimus at a starting dose of 10 mg daily and will be adjusted up or down by 2.5 mg at 2-week intervals to attain a trough concentration of 5-15 ng/mL."
42780|NCT02332902|E1|Reported Event|Intervention|"This is a single arm intervention using Everolimus.~Everyone in the study will receive Everolimus at a starting dose of 10 mg daily and will be adjusted up or down by 2.5 mg at 2-week intervals to attain a trough concentration of 5-15 ng/mL."
42781|NCT02332889|B1|Baseline|Decitabine/Vaccine Therapy|"Biological/Vaccine: Vaccine (autologous dendritic cells) and Drug: Decitabine and Hiltonol~Vaccine (autologous dendritic cells): Prior to vaccination, DC will be thawed, washed once with normal saline containing 1% human serum albumin, and viability will be checked (must be > 70%). Peptide pulsed DC will be placed in 1 ml tuberculin syringe(s) and transferred to the study physician for vaccination~Decitabine and Hiltonol: Patients will receive DAC at a dose of 10 mg/m2/d intravenously (IV) over one hour on days 1-5 of week 1. Hiltonol will be given intramuscularly at the same site immediately following vaccine"
42782|NCT02332889|P1|Participant Flow|Decitabine/Vaccine Therapy|"Biological/Vaccine: Vaccine (autologous dendritic cells) and Drug: Decitabine and Hiltonol~Vaccine (autologous dendritic cells [DC]): Prior to vaccination, DC will be thawed, washed once with normal saline containing 1% human serum albumin, and viability will be checked (must be > 70%). Peptide pulsed DC will be placed in 1 ml tuberculin syringe(s) and transferred to the study physician for vaccination~Decitabine and Hiltonol: Patients will receive 5-aza-2-deoxycytidine (DAC) at a dose of 10 mg/m2/d intravenously (IV) over one hour on days 1-5 of week 1. Hiltonol will be given intramuscularly at the same site immediately following vaccine"
42783|NCT02332889|O1|Outcome|Decitabine/Vaccine Therapy|"Biological/Vaccine: Vaccine (autologous dendritic cells) and Drug: Decitabine and Hiltonol~Vaccine (autologous dendritic cells): Prior to vaccination, DC will be thawed, washed once with normal saline containing 1% human serum albumin, and viability will be checked (must be > 70%). Peptide pulsed DC will be placed in 1 ml tuberculin syringe(s) and transferred to the study physician for vaccination~Decitabine and Hiltonol: Patients will receive DAC at a dose of 10 mg/m2/d intravenously (IV) over one hour on days 1-5 of week 1. Hiltonol will be given intramuscularly at the same site immediately following vaccine"
67806|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
42784|NCT02332889|E1|Reported Event|Decitabine/Vaccine Therapy|"Biological/Vaccine: Vaccine (autologous dendritic cells) and Drug: Decitabine and Hiltonol~Vaccine (autologous dendritic cells): Prior to vaccination, DC will be thawed, washed once with normal saline containing 1% human serum albumin, and viability will be checked (must be > 70%). Peptide pulsed DC will be placed in 1 ml tuberculin syringe(s) and transferred to the study physician for vaccination~Decitabine and Hiltonol: Patients will receive DAC at a dose of 10 mg/m2/d intravenously (IV) over one hour on days 1-5 of week 1. Hiltonol will be given intramuscularly at the same site immediately following vaccine"
42785|NCT02332798|B4|Baseline|Total|Total of all reporting groups
42786|NCT02332798|B3|Baseline|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42787|NCT02332798|B2|Baseline|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42788|NCT02332798|B1|Baseline|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42789|NCT02332798|P3|Participant Flow|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42790|NCT02332798|P2|Participant Flow|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42791|NCT02332798|P1|Participant Flow|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 milligram (mg) twice daily (BID) for 14 consecutive days with the last dose occurring in the morning on Day 14.
42792|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42793|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42794|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42795|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42796|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42797|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42798|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42799|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42800|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42801|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42802|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42803|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42804|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42805|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42806|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42807|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42808|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42809|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42810|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42811|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42812|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42813|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42814|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42815|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42816|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42817|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42818|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42819|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
43473|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
42822|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42823|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42824|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42825|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42826|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42827|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42828|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42829|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42830|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42831|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42832|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42833|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42834|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42835|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42836|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42837|NCT02332798|E3|Reported Event|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42838|NCT02332798|E2|Reported Event|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42839|NCT02332798|E1|Reported Event|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
42840|NCT02332707|B19|Baseline|Total|Total of all reporting groups
42841|NCT02332707|B18|Baseline|B8: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
42842|NCT02332707|B17|Baseline|B6: GT1 NC GZR+UPR+RVR (8 Weeks)|In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
42843|NCT02332707|B16|Baseline|B16: GT2 C GZR+UPR+RZR (16 Weeks)|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 16 weeks.
42844|NCT02332707|B15|Baseline|B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.
42845|NCT02332707|B14|Baseline|B14: GT2 C GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42846|NCT02332707|B13|Baseline|B13: GT1 C GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42847|NCT02332707|B12|Baseline|B12: GT1 C GZR+UPR+RZR (8 Weeks)|In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
42848|NCT02332707|B11|Baseline|B11: GT2 NC GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42849|NCT02332707|B10|Baseline|B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.
42850|NCT02332707|B9|Baseline|B9: GT1 NC GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42851|NCT02332707|B8|Baseline|A8: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.
42852|NCT02332707|B7|Baseline|A7: GT2 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.
42853|NCT02332707|B6|Baseline|A6: GT1 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.
42854|NCT02332707|B5|Baseline|A5: GT1 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.
42855|NCT02332707|B4|Baseline|A4: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + RZR 60 mg q.d. by mouth for 8 weeks.
42856|NCT02332707|B3|Baseline|A3: GT2 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + EBR 50 mg q.d. by mouth for 8 weeks.
42857|NCT02332707|B2|Baseline|A2: GT1 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 300 mg + ruzasvir (RZR) 60 mg q.d. by mouth for 8 weeks.
67807|NCT02153489|O2|Outcome|Placebo|Placebo BID
42858|NCT02332707|B1|Baseline|A1: GT1 NC GZR+UPR+EBR (8 Weeks)|In Part A, Hepatitis C virus (HCV) genotype (GT)1-infected non-cirrhotic (NC) participants took grazoprevir (GZR) 100 mg + uprifosbuvir (UPR) 300 mg + elbasvir (EBR) 50 mg once daily (q.d.) by mouth for 8 weeks.
42859|NCT02332707|P18|Participant Flow|B8: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
42860|NCT02332707|P17|Participant Flow|B6: GT1 NC GZR+UPR+RZR (8 Weeks)|In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
42861|NCT02332707|P16|Participant Flow|B16: GT2 C GZR+UPR+RZR (16 Weeks)|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 16 weeks.
42862|NCT02332707|P15|Participant Flow|B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.
42863|NCT02332707|P14|Participant Flow|B14: GT2 C GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42864|NCT02332707|P13|Participant Flow|B13: GT1 C GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42865|NCT02332707|P12|Participant Flow|B12: GT1 C GZR+UPR+RZR (8 Weeks)|In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
42866|NCT02332707|P11|Participant Flow|B11: GT2 NC GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42867|NCT02332707|P10|Participant Flow|B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.
42868|NCT02332707|P9|Participant Flow|B9: GT1 NC GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT1-infected NC participants took 2 fixed dose combination (FDC) tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42869|NCT02332707|P8|Participant Flow|A8: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.
42870|NCT02332707|P7|Participant Flow|A7: GT2 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.
42871|NCT02332707|P6|Participant Flow|A6: GT1 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.
42872|NCT02332707|P5|Participant Flow|A5: GT1 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.
42873|NCT02332707|P4|Participant Flow|A4: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + RZR 60 mg q.d. by mouth for 8 weeks.
42874|NCT02332707|P3|Participant Flow|A3: GT2 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + EBR 50 mg q.d. by mouth for 8 weeks.
42875|NCT02332707|P2|Participant Flow|A2: GT1 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 300 mg + ruzasvir (RZR) 60 mg q.d. by mouth for 8 weeks.
42876|NCT02332707|P1|Participant Flow|A1: GT1 NC GZR+UPR+EBR (8 Weeks)|In Part A, Hepatitis C virus (HCV) genotype (GT)1-infected non-cirrhotic (NC) participants took grazoprevir (GZR) 100 mg + uprifosbuvir (UPR) 300 mg + elbasvir (EBR) 50 mg once daily (q.d.) by mouth for 8 weeks.
42877|NCT02332707|O18|Outcome|16: GT2 C GZR+UPR+RZR (16 Weeks)|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 16 weeks.
42878|NCT02332707|O17|Outcome|B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.
42879|NCT02332707|O16|Outcome|B14: GT2 C GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42880|NCT02332707|O15|Outcome|B13: GT1 C GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42881|NCT02332707|O14|Outcome|B12: GT1 C GZR+UPR+RZR (8 Weeks)|In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
42882|NCT02332707|O13|Outcome|B11: GT2 NC GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42883|NCT02332707|O12|Outcome|B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.
42884|NCT02332707|O11|Outcome|B9: GT1 NC GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42885|NCT02332707|O10|Outcome|B8: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
42886|NCT02332707|O9|Outcome|A8: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.
42887|NCT02332707|O8|Outcome|A7: GT2 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.
42888|NCT02332707|O7|Outcome|B6: GT1 NC GZR+UPR+RVR (8 Weeks)|In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
42889|NCT02332707|O6|Outcome|A6: GT1 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.
42890|NCT02332707|O5|Outcome|A5: GT1 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.
42891|NCT02332707|O4|Outcome|A4: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + RZR 60 mg q.d. by mouth for 8 weeks.
42892|NCT02332707|O3|Outcome|A3: GT2 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + EBR 50 mg q.d. by mouth for 8 weeks.
42893|NCT02332707|O2|Outcome|A2: GT1 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 300 mg + ruzasvir (RZR) 60 mg q.d. by mouth for 8 weeks.
42894|NCT02332707|O1|Outcome|A1: GT1 NC GZR+UPR+EBR (8 Weeks)|In Part A, Hepatitis C virus (HCV) genotype (GT)1-infected non-cirrhotic (NC) participants took grazoprevir (GZR) 100 mg + uprifosbuvir (UPR) 300 mg + elbasvir (EBR) 50 mg once daily (q.d.) by mouth for 8 weeks.
42895|NCT02332707|O18|Outcome|16: GT2 C GZR+UPR+RZR (16 Weeks)|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 16 weeks.
42896|NCT02332707|O17|Outcome|B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.
42897|NCT02332707|O16|Outcome|B14: GT2 C GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42898|NCT02332707|O15|Outcome|B13: GT1 C GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42899|NCT02332707|O14|Outcome|B12: GT1 C GZR+UPR+RZR (8 Weeks)|In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
42900|NCT02332707|O13|Outcome|B11: GT2 NC GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42901|NCT02332707|O12|Outcome|B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.
42902|NCT02332707|O11|Outcome|B9: GT1 NC GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42903|NCT02332707|O10|Outcome|B8: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
42904|NCT02332707|O9|Outcome|A8: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.
42905|NCT02332707|O8|Outcome|A7: GT2 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.
42906|NCT02332707|O7|Outcome|B6: GT1 NC GZR+UPR+RVR (8 Weeks)|In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
42907|NCT02332707|O6|Outcome|A6: GT1 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.
42908|NCT02332707|O5|Outcome|A5: GT1 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.
42909|NCT02332707|O4|Outcome|A4: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + RZR 60 mg q.d. by mouth for 8 weeks.
42910|NCT02332707|O3|Outcome|A3: GT2 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + EBR 50 mg q.d. by mouth for 8 weeks.
42911|NCT02332707|O2|Outcome|A2: GT1 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 300 mg + ruzasvir (RZR) 60 mg q.d. by mouth for 8 weeks.
42912|NCT02332707|O1|Outcome|A1: GT1 NC GZR+UPR+EBR (8 Weeks)|In Part A, Hepatitis C virus (HCV) genotype (GT)1-infected non-cirrhotic (NC) participants took grazoprevir (GZR) 100 mg + uprifosbuvir (UPR) 300 mg + elbasvir (EBR) 50 mg once daily (q.d.) by mouth for 8 weeks.
42913|NCT02332707|O18|Outcome|16: GT2 C GZR+UPR+RZR (16 Weeks)|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 16 weeks.
42914|NCT02332707|O17|Outcome|B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.
42915|NCT02332707|O16|Outcome|B14: GT2 C GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42916|NCT02332707|O15|Outcome|B13: GT1 C GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42917|NCT02332707|O14|Outcome|B12: GT1 C GZR+UPR+RZR (8 Weeks)|In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
42918|NCT02332707|O13|Outcome|B11: GT2 NC GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42919|NCT02332707|O12|Outcome|B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.
42920|NCT02332707|O11|Outcome|B9: GT1 NC GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42921|NCT02332707|O10|Outcome|B8: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
42922|NCT02332707|O9|Outcome|A8: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.
42923|NCT02332707|O8|Outcome|A7: GT2 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.
42924|NCT02332707|O7|Outcome|B6: GT1 NC GZR+UPR+RVR (8 Weeks)|In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
42925|NCT02332707|O6|Outcome|A6: GT1 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.
42926|NCT02332707|O5|Outcome|A5: GT1 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.
42927|NCT02332707|O4|Outcome|A4: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + RZR 60 mg q.d. by mouth for 8 weeks.
42928|NCT02332707|O3|Outcome|A3: GT2 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + EBR 50 mg q.d. by mouth for 8 weeks.
42929|NCT02332707|O2|Outcome|A2: GT1 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 300 mg + ruzasvir (RZR) 60 mg q.d. by mouth for 8 weeks.
42930|NCT02332707|O1|Outcome|A1: GT1 NC GZR+UPR+EBR (8 Weeks)|In Part A, Hepatitis C virus (HCV) genotype (GT)1-infected non-cirrhotic (NC) participants took grazoprevir (GZR) 100 mg + uprifosbuvir (UPR) 300 mg + elbasvir (EBR) 50 mg once daily (q.d.) by mouth for 8 weeks.
42931|NCT02332707|O18|Outcome|16: GT2 C GZR+UPR+RZR (16 Weeks)|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 16 weeks.
42932|NCT02332707|O17|Outcome|B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.
42933|NCT02332707|O16|Outcome|B14: GT2 C GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42934|NCT02332707|O15|Outcome|B13: GT1 C GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42935|NCT02332707|O14|Outcome|B12: GT1 C GZR+UPR+RZR (8 Weeks)|In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
42936|NCT02332707|O13|Outcome|B11: GT2 NC GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42937|NCT02332707|O12|Outcome|B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.
42938|NCT02332707|O11|Outcome|B9: GT1 NC GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42939|NCT02332707|O10|Outcome|B8: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
42940|NCT02332707|O9|Outcome|A8: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.
42941|NCT02332707|O8|Outcome|A7: GT2 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.
42942|NCT02332707|O7|Outcome|B6: GT1 NC GZR+UPR+RVR (8 Weeks)|In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
42943|NCT02332707|O6|Outcome|A6: GT1 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.
42944|NCT02332707|O5|Outcome|A5: GT1 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.
42945|NCT02332707|O4|Outcome|A4: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + RZR 60 mg q.d. by mouth for 8 weeks.
42946|NCT02332707|O3|Outcome|A3: GT2 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + EBR 50 mg q.d. by mouth for 8 weeks.
42947|NCT02332707|O2|Outcome|A2: GT1 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 300 mg + ruzasvir (RZR) 60 mg q.d. by mouth for 8 weeks.
42948|NCT02332707|O1|Outcome|A1: GT1 NC GZR+UPR+EBR (8 Weeks)|In Part A, Hepatitis C virus (HCV) genotype (GT)1-infected non-cirrhotic (NC) participants took grazoprevir (GZR) 100 mg + uprifosbuvir (UPR) 300 mg + elbasvir (EBR) 50 mg once daily (q.d.) by mouth for 8 weeks.
42949|NCT02332707|E18|Reported Event|B16: GT2 C GZR+UPR+RZR (16 Weeks)|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 16 weeks.
42950|NCT02332707|E17|Reported Event|B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.
42951|NCT02332707|E16|Reported Event|B14: GT2 C GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42952|NCT02332707|E15|Reported Event|B13: GT1 C GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42953|NCT02332707|E14|Reported Event|B12: GT1 C GZR+UPR+RZR (8 Weeks)|In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
42954|NCT02332707|E13|Reported Event|B11: GT2 NC GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42955|NCT02332707|E12|Reported Event|B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBVMax 62 Characters...|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.
42956|NCT02332707|E11|Reported Event|B9: GT1 NC GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
42957|NCT02332707|E10|Reported Event|B8: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
42958|NCT02332707|E9|Reported Event|B6: GT1 NC GZR+UPR+RVR (8 Weeks)|In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
42959|NCT02332707|E8|Reported Event|A8: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.
42960|NCT02332707|E7|Reported Event|A7: GT2 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.
42961|NCT02332707|E6|Reported Event|A6: GT1 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.
42962|NCT02332707|E5|Reported Event|A5: GT1 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.
42963|NCT02332707|E4|Reported Event|A4: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + RZR 60 mg q.d. by mouth for 8 weeks.
42964|NCT02332707|E3|Reported Event|A3: GT2 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + EBR 50 mg q.d. by mouth for 8 weeks.
42965|NCT02332707|E2|Reported Event|A2: GT1 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 300 mg + ruzasvir (RZR) 60 mg q.d. by mouth for 8 weeks.
42966|NCT02332707|E1|Reported Event|A1: GT1 NC GZR+UPR+EBR (8 Weeks)|In Part A, Hepatitis C virus (HCV) genotype (GT)1-infected non-cirrhotic (NC) participants took grazoprevir (GZR) 100 mg + uprifosbuvir (UPR) 300 mg + elbasvir (EBR) 50 mg once daily (q.d.) by mouth for 8 weeks.
42967|NCT02332590|B3|Baseline|Total|Total of all reporting groups
42968|NCT02332590|B2|Baseline|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants completed 24 weeks treatment period had the option to continue in open-label treatment period and received sarilumab 200 mg q2w until commercial availability of sarilumab in the country or maximum of 276 weeks.
42969|NCT02332590|B1|Baseline|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants completed 24 weeks treatment period had the option to continue in open-label treatment period and received sarilumab 200 mg q2w until commercial availability of sarilumab in the country or maximum of 276 weeks.
42970|NCT02332590|P2|Participant Flow|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants completed 24 weeks treatment period had the option to continue in open-label treatment period and received sarilumab 200 mg q2w until commercial availability of sarilumab in the country or maximum of 276 weeks.
42971|NCT02332590|P1|Participant Flow|Adalimumab 40 mg|Adalimumab 40 mg subcutaneous (SC) injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (<20% improvement from baseline tender joint count [TJC] and swollen joint count [SJC] for 2 consecutive visits) at or after Week 16 until Week 23. Participants completed 24 weeks treatment period had the option to continue in open-label treatment period and received sarilumab 200 mg q2w until commercial availability of sarilumab in the country or maximum of 276 weeks.
42972|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
42973|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
42974|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
42975|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
42976|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
42977|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43474|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
42978|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
42979|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
42980|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
42981|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
42982|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
42983|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
42984|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
42985|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
42986|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
42987|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
42988|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
42989|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
42990|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
42991|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
42992|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
42993|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
42994|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
42995|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43033|NCT02332239|B2|Baseline|Control (EUC)|"In-ED brief session, discussing home safety & nutrition~Eight-week longitudinal home safety & nutrition text-message program~Control (EUC): 1) In-ED brief session, discussing home safety & nutrition 2) Eight-week longitudinal home safety & nutrition text-message program"
42996|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
42997|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
42998|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
42999|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43000|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43001|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43002|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43003|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43004|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43005|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43006|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43007|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43008|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43009|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43010|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43011|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43012|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43013|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43053|NCT02331940|O2|Outcome|Respimat|"Tiotropium was delivered via the Respimat® Soft Mist Inhaler,~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Respimat: Inhalation via the Respimat once daily"
43014|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43015|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43016|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43017|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43018|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43019|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43020|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43021|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43022|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43023|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43024|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43025|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43026|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43027|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43028|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43029|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43030|NCT02332590|E2|Reported Event|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43031|NCT02332590|E1|Reported Event|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
43032|NCT02332239|B3|Baseline|Total|Total of all reporting groups
43146|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
43034|NCT02332239|B1|Baseline|iDOVE Intervention (ED+Text)|"In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention~Eight-week longitudinal tailored CBT-based text-message program~iDOVE Intervention (ED+text): 1) In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention 2) Eight-week longitudinal tailored text-message program"
43035|NCT02332239|P2|Participant Flow|Control (EUC)|"In-ED brief session, discussing home safety & nutrition~Eight-week longitudinal home safety & nutrition text-message program~Control (EUC): 1) In-ED brief session, discussing home safety & nutrition 2) Eight-week longitudinal home safety & nutrition text-message program"
43036|NCT02332239|P1|Participant Flow|iDOVE Intervention (ED+Text)|"In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention~Eight-week longitudinal tailored CBT-based text-message program~iDOVE Intervention (ED+text): 1) In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention 2) Eight-week longitudinal tailored text-message program"
43037|NCT02332239|O2|Outcome|Control (EUC)|"In-ED brief session, discussing home safety & nutrition~Eight-week longitudinal home safety & nutrition text-message program~Control (EUC): 1) In-ED brief session, discussing home safety & nutrition 2) Eight-week longitudinal home safety & nutrition text-message program"
43038|NCT02332239|O1|Outcome|iDOVE Intervention (ED+Text)|"In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention~Eight-week longitudinal tailored CBT-based text-message program~iDOVE Intervention (ED+text): 1) In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention 2) Eight-week longitudinal tailored text-message program"
43039|NCT02332239|O1|Outcome|iDOVE Intervention (ED+Text)|"In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention~Eight-week longitudinal tailored CBT-based text-message program~iDOVE Intervention (ED+text): 1) In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention 2) Eight-week longitudinal tailored text-message program"
43040|NCT02332239|O2|Outcome|Control (EUC)|"In-ED brief session, discussing home safety & nutrition~Eight-week longitudinal home safety & nutrition text-message program~Control (EUC): 1) In-ED brief session, discussing home safety & nutrition 2) Eight-week longitudinal home safety & nutrition text-message program"
43041|NCT02332239|O1|Outcome|iDOVE Intervention (ED+Text)|"In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention~Eight-week longitudinal tailored CBT-based text-message program~iDOVE Intervention (ED+text): 1) In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention 2) Eight-week longitudinal tailored text-message program"
43042|NCT02332239|O2|Outcome|Control (EUC)|"In-ED brief session, discussing home safety & nutrition~Eight-week longitudinal home safety & nutrition text-message program~Control (EUC): 1) In-ED brief session, discussing home safety & nutrition 2) Eight-week longitudinal home safety & nutrition text-message program"
43043|NCT02332239|O1|Outcome|iDOVE Intervention (ED+Text)|"In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention~Eight-week longitudinal tailored CBT-based text-message program~iDOVE Intervention (ED+text): 1) In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention 2) Eight-week longitudinal tailored text-message program"
43044|NCT02332239|O2|Outcome|Control (EUC)|"In-ED brief session, discussing home safety & nutrition~Eight-week longitudinal home safety & nutrition text-message program~Control (Enhanced Usual Care (EUC)): 1) In-ED brief session, discussing home safety & nutrition 2) Eight-week longitudinal home safety & nutrition text-message program"
43045|NCT02332239|O1|Outcome|iDOVE Intervention (ED+Text)|"In-ED brief session, introducing basic principles of cognitive behavioral theory (CBT) and the structure of the text-message portion of the intervention~Eight-week longitudinal tailored CBT-based text-message program~iDOVE Intervention (ED+text): 1) In-ED brief session, introducing basic principles of cognitive behavioral theory (CBT) and the structure of the text-message portion of the intervention 2) Eight-week longitudinal tailored text-message program"
43046|NCT02332239|E2|Reported Event|Control (EUC)|"In-ED brief session, discussing home safety & nutrition~Eight-week longitudinal home safety & nutrition text-message program~Control (EUC): 1) In-ED brief session, discussing home safety & nutrition 2) Eight-week longitudinal home safety & nutrition text-message program"
43047|NCT02332239|E1|Reported Event|iDOVE Intervention (ED+Text)|"In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention~Eight-week longitudinal tailored CBT-based text-message program~iDOVE Intervention (ED+text): 1) In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention 2) Eight-week longitudinal tailored text-message program"
43048|NCT02331940|B3|Baseline|Total|Total of all reporting groups
43049|NCT02331940|B2|Baseline|Respimat|"Tiotropium was delivered via the Respimat® Soft Mist Inhaler,~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Respimat: Inhalation via the Respimat once daily"
43050|NCT02331940|B1|Baseline|Handihaler|"Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Handihaler: Inhalation via the HandiHaler once daily"
43051|NCT02331940|P2|Participant Flow|Respimat|"Tiotropium was delivered via the Respimat® Soft Mist Inhaler,~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Respimat: Inhalation via the Respimat once daily"
43052|NCT02331940|P1|Participant Flow|Handihaler|"Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Handihaler: Inhalation via the HandiHaler once daily"
43054|NCT02331940|O1|Outcome|Handihaler|"Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Handihaler: Inhalation via the HandiHaler once daily"
43055|NCT02331940|O2|Outcome|Respimat|"Tiotropium was delivered via the Respimat® Soft Mist Inhaler,~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Respimat: Inhalation via the Respimat once daily"
43056|NCT02331940|O1|Outcome|Handihaler|"Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Handihaler: Inhalation via the HandiHaler once daily"
43057|NCT02331940|O2|Outcome|Respimat|"Tiotropium was delivered via the Respimat® Soft Mist Inhaler,~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Respimat: Inhalation via the Respimat once daily"
43058|NCT02331940|O1|Outcome|Handihaler|"Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Handihaler: Inhalation via the HandiHaler once daily"
43059|NCT02331940|O2|Outcome|Respimat|"Tiotropium was delivered via the Respimat® Soft Mist Inhaler,~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Respimat: Inhalation via the Respimat once daily"
43060|NCT02331940|O1|Outcome|Handihaler|"Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Handihaler: Inhalation via the HandiHaler once daily"
43061|NCT02331940|E2|Reported Event|Respimat|"Tiotropium was delivered via the Respimat® Soft Mist Inhaler,~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Respimat: Inhalation via the Respimat once daily"
43062|NCT02331940|E1|Reported Event|Handihaler|"Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Handihaler: Inhalation via the HandiHaler once daily"
43063|NCT02331589|B3|Baseline|Total|Total of all reporting groups
43064|NCT02331589|B2|Baseline|Placebo (for KRG)|"placebo (for KRG) for 3 weeks~Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
43065|NCT02331589|B1|Baseline|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks~KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
43066|NCT02331589|P2|Participant Flow|Placebo (for KRG)|"placebo (for KRG) for 3 weeks~Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
43067|NCT02331589|P1|Participant Flow|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks~KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
43068|NCT02331589|O2|Outcome|Placebo (for KRG)|"placebo (for KRG) for 3 weeks~Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
43069|NCT02331589|O1|Outcome|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks~KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
43070|NCT02331589|O2|Outcome|Placebo (for KRG)|"placebo (for KRG) for 3 weeks~Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
43071|NCT02331589|O1|Outcome|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks~KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
43072|NCT02331589|O2|Outcome|Placebo (for KRG)|"placebo (for KRG) for 3 weeks~Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
43073|NCT02331589|O1|Outcome|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks~KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
43074|NCT02331589|O2|Outcome|Placebo (for KRG)|"placebo (for KRG) for 3 weeks~Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
43075|NCT02331589|O1|Outcome|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks~KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
43076|NCT02331589|E2|Reported Event|Placebo (for KRG)|"placebo (for KRG) for 3 weeks~Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
43077|NCT02331589|E1|Reported Event|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks~KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
43078|NCT02331446|B5|Baseline|Total|Total of all reporting groups
43079|NCT02331446|B4|Baseline|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
43080|NCT02331446|B3|Baseline|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
43081|NCT02331446|B2|Baseline|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
43082|NCT02331446|B1|Baseline|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
43083|NCT02331446|P4|Participant Flow|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
43475|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
43084|NCT02331446|P3|Participant Flow|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
43085|NCT02331446|P2|Participant Flow|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
43086|NCT02331446|P1|Participant Flow|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
43087|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
43088|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
43089|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
43090|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
43091|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
43092|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
43093|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
43094|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
43095|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
43096|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
43097|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
43098|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
43099|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
43100|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
43101|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
43102|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
43103|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
43104|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
43105|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
43106|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
43107|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
43108|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
43109|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
43110|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
43111|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
43112|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
43113|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
43114|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
67808|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
43115|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
43116|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
43117|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
43118|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
43119|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
43120|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
43121|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
43122|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
43123|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
43124|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
43125|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
43126|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
43127|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
43128|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
43129|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
43130|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
43131|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
43132|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
43133|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
43134|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
43135|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
43136|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
43137|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
43138|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
43139|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
43140|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
43141|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
43142|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
43143|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
43144|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
43145|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
43147|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
43148|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
43149|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
43150|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
43151|NCT02331446|E4|Reported Event|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
43152|NCT02331446|E3|Reported Event|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
43153|NCT02331446|E2|Reported Event|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
43154|NCT02331446|E1|Reported Event|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
43155|NCT02331108|B7|Baseline|Total|Total of all reporting groups
43156|NCT02331108|B6|Baseline|Sevoflurane in 50% Nitrous, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43157|NCT02331108|B5|Baseline|Sevoflurane in 100% Oxygen, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43158|NCT02331108|B4|Baseline|Propofol With Phenylephrine, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43159|NCT02331108|B3|Baseline|Propofol, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43160|NCT02331108|B2|Baseline|Sevoflurane in 50% Nitrous, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43161|NCT02331108|B1|Baseline|Sevoflurane in 100% Oxygen, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43162|NCT02331108|P6|Participant Flow|Sevoflurane in 50% Nitrous, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43163|NCT02331108|P5|Participant Flow|Sevoflurane in 100% Oxygen, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43164|NCT02331108|P4|Participant Flow|Propofol With Phenylephrine, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43165|NCT02331108|P3|Participant Flow|Propofol, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43166|NCT02331108|P2|Participant Flow|Sevoflurane in 50% Nitrous, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43167|NCT02331108|P1|Participant Flow|Sevoflurane in 100% Oxygen, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43168|NCT02331108|O2|Outcome|Propofol With Phenylephrine, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43476|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
43169|NCT02331108|O1|Outcome|Propofol, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43170|NCT02331108|O6|Outcome|Sevoflurane in 50% Nitrous, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43171|NCT02331108|O5|Outcome|Sevoflurane in 100% Oxygen, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43172|NCT02331108|O4|Outcome|Propofol With Phenylephrine, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43173|NCT02331108|O3|Outcome|Propofol, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43174|NCT02331108|O2|Outcome|Sevoflurane in 50% Nitrous, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43175|NCT02331108|O1|Outcome|Sevoflurane in 100% Oxygen, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43176|NCT02331108|O6|Outcome|Sevoflurane in 50% Nitrous, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43177|NCT02331108|O5|Outcome|Sevoflurane in 100% Oxygen, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43178|NCT02331108|O4|Outcome|Propofol With Phenylephrine, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43179|NCT02331108|O3|Outcome|Propofol, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43180|NCT02331108|O2|Outcome|Sevoflurane in 50% Nitrous, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43181|NCT02331108|O1|Outcome|Sevoflurane in 100% Oxygen, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43182|NCT02331108|E6|Reported Event|Sevoflurane in 50% Nitrous, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43183|NCT02331108|E5|Reported Event|Sevoflurane in 100% Oxygen, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43184|NCT02331108|E4|Reported Event|Propofol With Phenylephrine, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43185|NCT02331108|E3|Reported Event|Propofol, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43186|NCT02331108|E2|Reported Event|Sevoflurane in 50% Nitrous, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43477|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
43478|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
43187|NCT02331108|E1|Reported Event|Sevoflurane in 100% Oxygen, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
43188|NCT02330588|B6|Baseline|Total|Total of all reporting groups
43189|NCT02330588|B5|Baseline|eHealth Control Arm (Heads Up)|
43190|NCT02330588|B4|Baseline|Intervention Arm (Move It, Normative Feedback)|
43191|NCT02330588|B3|Baseline|Intervention Arm (Move It, Injunctive Feedback)|
43192|NCT02330588|B2|Baseline|Intervention Arm (Eat It, Normative Feedback)|
43193|NCT02330588|B1|Baseline|Intervention Arm (Eat It, Injunctive Feedback)|
43194|NCT02330588|P5|Participant Flow|eHealth Control|Parents randomly assigned to the control arm will include information on children's lifestyle behaviors only (no intervention questions).
43195|NCT02330588|P4|Participant Flow|Move It (Normative Feedback)|Parents are presented with two questions about screen time and moderate-to-vigorous physical activity (MVPA); answers are contrasted with normative feedback (i.e., referent data from Canadian children).
43196|NCT02330588|P3|Participant Flow|Move It (Injunctive Feedback)|Parents are presented with two questions about screen time and moderate-to-vigorous physical activity (MVPA); answers are contrasted with injunctive feedback (i.e., Canadian guidelines).
43197|NCT02330588|P2|Participant Flow|Eat It (Normative Feedback)|Parents are presented with two questions about portion size and sugar-sweetened beverages; answers are contrasted with normative feedback (i.e., referent data from Canadian children).
43198|NCT02330588|P1|Participant Flow|Eat It (Injunctive Feedback)|Parents are presented with two questions about portion size and sugar-sweetened beverages; answers are contrasted with injunctive feedback (i.e., Canadian guidelines).
43199|NCT02330588|O6|Outcome|All Groups (Total)|
43200|NCT02330588|O5|Outcome|Heads Up (eHealth Control)|
43201|NCT02330588|O4|Outcome|Move It (Normative Feedback)|
43202|NCT02330588|O3|Outcome|Move It (Injunctive Feedback)|
43203|NCT02330588|O2|Outcome|Eat It (Normative Feedback)|
43204|NCT02330588|O1|Outcome|Eat It (Injunctive Feedback)|
43205|NCT02330588|O6|Outcome|eHealth Control|
43206|NCT02330588|O5|Outcome|Move It (Normative Feedback)|
43207|NCT02330588|O4|Outcome|Move It (Injunctive Feedback)|
43208|NCT02330588|O3|Outcome|Eat It (Normative Feedback)|
43209|NCT02330588|O2|Outcome|Eat It (Injunctive Feedback)|
43210|NCT02330588|O1|Outcome|Feasibility (Uptake)|All groups (brief intervention + eHealth control)
43211|NCT02330588|O6|Outcome|eHealth Control|
43212|NCT02330588|O5|Outcome|Move It (Normative Feedback)|
43213|NCT02330588|O4|Outcome|Move It (Injunctive Feedback)|
43214|NCT02330588|O3|Outcome|Eat It (Normative Feedback)|
43215|NCT02330588|O2|Outcome|Eat It (Injunctive Feedback)|
43216|NCT02330588|O1|Outcome|All Groups (Total)|All groups (four brief interventions + eHealth control)
43217|NCT02330588|E5|Reported Event|eHealth Control|
43218|NCT02330588|E4|Reported Event|Move It (Normative)|
43219|NCT02330588|E3|Reported Event|Move It (Injunctive)|
43220|NCT02330588|E2|Reported Event|Eat It (Normative)|
43221|NCT02330588|E1|Reported Event|Eat It (Injunctive)|
43222|NCT02330523|B3|Baseline|Total|Total of all reporting groups
43223|NCT02330523|B2|Baseline|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
43224|NCT02330523|B1|Baseline|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
43225|NCT02330523|P2|Participant Flow|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
43226|NCT02330523|P1|Participant Flow|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
43479|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
43480|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
43227|NCT02330523|O2|Outcome|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
43228|NCT02330523|O1|Outcome|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
43229|NCT02330523|O2|Outcome|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
43230|NCT02330523|O1|Outcome|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
43231|NCT02330523|O2|Outcome|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
43232|NCT02330523|O1|Outcome|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
43233|NCT02330523|E2|Reported Event|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
43234|NCT02330523|E1|Reported Event|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
43235|NCT02330276|B4|Baseline|Total|Total of all reporting groups
43236|NCT02330276|B3|Baseline|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
43237|NCT02330276|B2|Baseline|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
43238|NCT02330276|B1|Baseline|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
43239|NCT02330276|P3|Participant Flow|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
43240|NCT02330276|P2|Participant Flow|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
43241|NCT02330276|P1|Participant Flow|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
43242|NCT02330276|O3|Outcome|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
43243|NCT02330276|O2|Outcome|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
43244|NCT02330276|O1|Outcome|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
43245|NCT02330276|O3|Outcome|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
43246|NCT02330276|O2|Outcome|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
43247|NCT02330276|O1|Outcome|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
43248|NCT02330276|O3|Outcome|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
43249|NCT02330276|O2|Outcome|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
43250|NCT02330276|O1|Outcome|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
43251|NCT02330276|O3|Outcome|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
43252|NCT02330276|O2|Outcome|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
43431|NCT02329587|O2|Outcome|ERP Plus Sham tDCS|"ERP plus sham tDCS of right inferior frontal gyrus~ERP plus sham tDCS: Participants in the ERP plus sham tDCS arm will receive an 11-session program, including 10 sessions which include both sham tDCS and ERP. During these sessions, 20 minutes of sham tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise."
43253|NCT02330276|O1|Outcome|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
43254|NCT02330276|O3|Outcome|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
43255|NCT02330276|O2|Outcome|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
43256|NCT02330276|O1|Outcome|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
43257|NCT02330276|E3|Reported Event|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
43258|NCT02330276|E2|Reported Event|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
43259|NCT02330276|E1|Reported Event|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
43260|NCT02330172|B3|Baseline|Total|Total of all reporting groups
43261|NCT02330172|B2|Baseline|Rocuronium 0.9 - Sugammadex|"When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation.~When the end of operation,, a injection of neostigmine or sugammadex be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
43262|NCT02330172|B1|Baseline|Rocuronium 0.45 - Neostigmine|"when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation.~When the end of operation, a injection of neostigmine or sugammadex will be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
43263|NCT02330172|P2|Participant Flow|Rocuronium 0.9 - Sugammadex|"When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation.~When the end of operation,, a injection of neostigmine or sugammadex be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
43264|NCT02330172|P1|Participant Flow|Rocuronium 0.45 - Neostigmine|"when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation.~When the end of operation, a injection of neostigmine or sugammadex will be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
43265|NCT02330172|O2|Outcome|Rocuronium 0.9 - Sugammadex|"When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation.~When the end of operation,, a injection of neostigmine or sugammadex be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
43266|NCT02330172|O1|Outcome|Rocuronium 0.45 - Neostigmine|"when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation.~When the end of operation, a injection of neostigmine or sugammadex will be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
46549|NCT02305277|E3|Reported Event|BIA 9-1067 25 mg CM|BIA 9-1067 25 mg CM CM - clinical micronized
43267|NCT02330172|O2|Outcome|Rocuronium 0.9 - Sugammadex|"When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation.~When the end of operation,, a injection of neostigmine or sugammadex be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
43268|NCT02330172|O1|Outcome|Rocuronium 0.45 - Neostigmine|"when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation.~When the end of operation, a injection of neostigmine or sugammadex will be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
43269|NCT02330172|E2|Reported Event|Rocuronium 0.9 - Sugammadex|"When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation.~When the end of operation,, a injection of neostigmine or sugammadex be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
43270|NCT02330172|E1|Reported Event|Rocuronium 0.45 - Neostigmine|"when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation.~When the end of operation, a injection of neostigmine or sugammadex will be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
43271|NCT02330055|B3|Baseline|Total|Total of all reporting groups
43272|NCT02330055|B2|Baseline|Forty-five Degrees Elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~Forty-five degrees elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient."
43273|NCT02330055|B1|Baseline|Non-elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~non-elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire"
43274|NCT02330055|P2|Participant Flow|Forty-five Degrees Elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~Forty-five degrees elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient."
43275|NCT02330055|P1|Participant Flow|Non-elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~non-elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire"
43303|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
43432|NCT02329587|O1|Outcome|ERP Plus tDCS|"ERP plus anodal tDCS of right inferior frontal gyrus~ERP plus tDCS: Participants in the ERP plus tDCS arm will receive an 11-session program, including 10 sessions which include both tDCS and ERP. During these sessions, 20 minutes of anodal tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise."
43276|NCT02330055|O2|Outcome|Forty-five Degrees Elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~Forty-five degrees elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient."
43277|NCT02330055|O1|Outcome|Non-elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~non-elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire"
43278|NCT02330055|O2|Outcome|Forty-five Degrees Elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~Forty-five degrees elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient."
43279|NCT02330055|O1|Outcome|Non-elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~non-elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire"
43280|NCT02330055|O2|Outcome|Forty-five Degrees Elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~Forty-five degrees elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient."
43281|NCT02330055|O1|Outcome|Non-elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~non-elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire"
43282|NCT02330055|O2|Outcome|Forty-five Degrees Elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~Forty-five degrees elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient."
43304|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
67809|NCT02153489|O2|Outcome|Placebo|Placebo BID
43283|NCT02330055|O1|Outcome|Non-elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~non-elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire"
43284|NCT02330055|O2|Outcome|Forty-five Degrees Elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~Forty-five degrees elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient."
43285|NCT02330055|O1|Outcome|Non-elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~non-elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire"
43286|NCT02330055|O2|Outcome|Forty-five Degrees Elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~Forty-five degrees elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient."
43287|NCT02330055|O1|Outcome|Non-elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~non-elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire"
43288|NCT02330055|O2|Outcome|Forty-five Degrees Elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~Forty-five degrees elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient."
43289|NCT02330055|O1|Outcome|Non-elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~non-elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire"
43333|NCT02329730|P1|Participant Flow|Healthy Subjects-1μg/ml ESAT6-CFP10 & TB-PPD|"The same healthy subjects inject 1μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and TB-PPD only one time in every healthy subjects ."
43290|NCT02330055|E2|Reported Event|Forty-five Degrees Elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~Forty-five degrees elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient."
43291|NCT02330055|E1|Reported Event|Non-elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~non-elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire"
43292|NCT02329964|B3|Baseline|Total|Total of all reporting groups
43293|NCT02329964|B2|Baseline|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
43294|NCT02329964|B1|Baseline|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
43295|NCT02329964|P2|Participant Flow|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
43296|NCT02329964|P1|Participant Flow|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
43297|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
43298|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
43299|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
43300|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
43301|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
43302|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
43424|NCT02329587|B1|Baseline|ERP Plus tDCS|"ERP plus anodal tDCS of right inferior frontal gyrus~ERP plus tDCS: Participants in the ERP plus tDCS arm will receive an 11-session program, including 10 sessions which include both tDCS and ERP. During these sessions, 20 minutes of anodal tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise."
43305|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
43306|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
43307|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
43308|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
43309|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
43310|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
43311|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
43312|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
43313|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
43314|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
43315|NCT02329964|E2|Reported Event|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
43316|NCT02329964|E1|Reported Event|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
43317|NCT02329730|B5|Baseline|Total|Total of all reporting groups
43318|NCT02329730|B4|Baseline|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43319|NCT02329730|B3|Baseline|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43481|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
46550|NCT02305277|E2|Reported Event|BIA 9-1067 5 mg TBM|BIA 9-1067 5 mg TBM TBM - to-be-marketed
43320|NCT02329730|B2|Baseline|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43321|NCT02329730|B1|Baseline|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43322|NCT02329730|P12|Participant Flow|Tuberculosis Subjects-20μg/ml ESAT6-CFP10 & Placebo|"The tuberculosis subjects inject 20μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects.~Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects."
43323|NCT02329730|P11|Participant Flow|Tuberculosis Subjects-10μg/ml ESAT6-CFP10 & Placebo|"The tuberculosis subjects inject 10μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects.~Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects."
43324|NCT02329730|P10|Participant Flow|Tuberculosis Subjects-5μg/ml ESAT6-CFP10 & Placebo|"The tuberculosis subjects inject 5μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects.~Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects."
43325|NCT02329730|P9|Participant Flow|Tuberculosis Subjects-1μg/ml ESAT6-CFP10 & Placebo|"The tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects.~Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects."
43326|NCT02329730|P8|Participant Flow|Tuberculosis Subjects-20μg/ml ESAT6-CFP10 & TB-PPD|"The same tuberculosis subjects inject 20μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects ."
43327|NCT02329730|P7|Participant Flow|Tuberculosis Subjects-10μg/ml ESAT6-CFP10 & TB-PPD|"The same tuberculosis subjects inject 10μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects ."
43328|NCT02329730|P6|Participant Flow|Tuberculosis Subjects-5μg/ml ESAT6-CFP10 & TB-PPD|"The same tuberculosis subjects inject 5μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects ."
43329|NCT02329730|P5|Participant Flow|Tuberculosis Subjects-1μg/ml ESAT6-CFP10 & TB-PPD|"The same tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects ."
43330|NCT02329730|P4|Participant Flow|Healthy Subjects-20μg/ml ESAT6-CFP10 & TB-PPD|"The same healthy subjects inject 20μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every healthy subjects ."
43331|NCT02329730|P3|Participant Flow|Healthy Subjects-10μg/ml ESAT6-CFP10 & TB-PPD|"The same healthy subjects inject 10μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every healthy subjects ."
43332|NCT02329730|P2|Participant Flow|Healthy Subjects-5μg/ml ESAT6-CFP10 & TB-PPD|"The same healthy subjects inject 5μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every healthy subjects ."
43433|NCT02329587|O2|Outcome|ERP Plus Sham tDCS|"ERP plus sham tDCS of right inferior frontal gyrus~ERP plus sham tDCS: Participants in the ERP plus sham tDCS arm will receive an 11-session program, including 10 sessions which include both sham tDCS and ERP. During these sessions, 20 minutes of sham tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise."
43334|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43335|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43336|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43337|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43338|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43339|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43340|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43341|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43342|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43343|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43344|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43345|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43425|NCT02329587|P2|Participant Flow|ERP Plus Sham tDCS|"Exposure and response prevention (ERP) plus sham transcranial direct current stimulation (tDCS) of right inferior frontal gyrus~ERP plus sham tDCS: Participants in the ERP plus sham tDCS arm will receive an 11-session program, including 10 sessions which include both sham tDCS and ERP. During these sessions, 20 minutes of sham tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise."
43346|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43347|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43348|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43349|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43350|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43351|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43352|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43353|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43354|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43355|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43356|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43357|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43426|NCT02329587|P1|Participant Flow|ERP Plus tDCS|"Exposure and response prevention (ERP) plus anodal transcranial direct current stimulation (tDCS) of right inferior frontal gyrus~ERP plus tDCS: Participants in the ERP plus tDCS arm will receive an 11-session program, including 10 sessions which include both tDCS and ERP. During these sessions, 20 minutes of anodal tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise."
43358|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43359|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43360|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43361|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43362|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43363|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43364|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43365|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43366|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43367|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43368|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43369|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43427|NCT02329587|O2|Outcome|ERP Plus Sham tDCS|"ERP plus sham tDCS of right inferior frontal gyrus~ERP plus sham tDCS: Participants in the ERP plus sham tDCS arm will receive an 11-session program, including 10 sessions which include both sham tDCS and ERP. During these sessions, 20 minutes of sham tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise."
67810|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
43370|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43371|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43372|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43373|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43374|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43375|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43376|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43377|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43378|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43379|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43380|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43381|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43428|NCT02329587|O1|Outcome|ERP Plus tDCS|"ERP plus anodal tDCS of right inferior frontal gyrus~ERP plus tDCS: Participants in the ERP plus tDCS arm will receive an 11-session program, including 10 sessions which include both tDCS and ERP. During these sessions, 20 minutes of anodal tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise."
46551|NCT02305277|E1|Reported Event|BIA 9-1067 5 mg CM|BIA 9-1067 5 mg CM CM - clinical micronized
43382|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43383|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43384|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43385|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43386|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43387|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43388|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43389|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43390|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43391|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43392|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43393|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
43429|NCT02329587|O2|Outcome|ERP Plus Sham tDCS|"ERP plus sham tDCS of right inferior frontal gyrus~ERP plus sham tDCS: Participants in the ERP plus sham tDCS arm will receive an 11-session program, including 10 sessions which include both sham tDCS and ERP. During these sessions, 20 minutes of sham tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise."
46552|NCT02305238|B4|Baseline|Total|Total of all reporting groups
43394|NCT02329730|E12|Reported Event|Tuberculosis Subjects- 20μg/ml EC and Placebo|The tuberculosis subjects inject 20μg/ml ESAT6-CFP10 and the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm the placebo.Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
43395|NCT02329730|E11|Reported Event|Tuberculosis Subjects- 10μg/ml EC and Placebo|The tuberculosis subjects inject 10μg/ml ESAT6-CFP10 and the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm the placebo.Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
43396|NCT02329730|E10|Reported Event|Tuberculosis Subjects- 5μg/ml EC and Placebo|The tuberculosis subjects inject 5μg/ml ESAT6-CFP10 and the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm the placebo.Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
43397|NCT02329730|E9|Reported Event|Tuberculosis Subjects- 1μg/ml EC and Placebo|The tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm the placebo.Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
43398|NCT02329730|E8|Reported Event|Tuberculosis Subjects- 20μg/ml EC and TB-PPD|The tuberculosis subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
43399|NCT02329730|E7|Reported Event|Tuberculosis Subjects- 10μg/ml EC and TB-PPD|The tuberculosis subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
43400|NCT02329730|E6|Reported Event|Tuberculosis Subjects- 5μg/ml EC and TB-PPD|The tuberculosis subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
43401|NCT02329730|E5|Reported Event|Tuberculosis Subjects- 1μg/mlEC and TB-PPD|The tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
43402|NCT02329730|E4|Reported Event|Healthy Subjects-20μg/ml EC and TB-PPD|The healthy subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
43403|NCT02329730|E3|Reported Event|Healthy Subjects-10μg/ml EC and TB-PPD|The healthy subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
43404|NCT02329730|E2|Reported Event|Healthy Subjects-5μg/ml EC and TB-PPD|The healthy subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
43405|NCT02329730|E1|Reported Event|Healthy Subjects-1μg/ml ECand TB-PPD|The healthy subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
43406|NCT02329600|B4|Baseline|Total|Total of all reporting groups
43407|NCT02329600|B3|Baseline|OLP and Corticosteroid and Green Tea|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.~green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
43430|NCT02329587|O1|Outcome|ERP Plus tDCS|"ERP plus anodal tDCS of right inferior frontal gyrus~ERP plus tDCS: Participants in the ERP plus tDCS arm will receive an 11-session program, including 10 sessions which include both tDCS and ERP. During these sessions, 20 minutes of anodal tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise."
43408|NCT02329600|B2|Baseline|OLP and Corticosteroid|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
43409|NCT02329600|B1|Baseline|Control Subjects|10 systemically healthy control subjects taking no medication.
43410|NCT02329600|P3|Participant Flow|OLP and Corticosteroid and Green Tea|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.~green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
43411|NCT02329600|P2|Participant Flow|OLP and Corticosteroid|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
43412|NCT02329600|P1|Participant Flow|Control Subjects|10 systemically healthy control subjects taking no medication.
43413|NCT02329600|O3|Outcome|OLP and Corticosteroid and Green Tea|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.~green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
43414|NCT02329600|O2|Outcome|OLP and Corticosteroid|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
43415|NCT02329600|O1|Outcome|Control Subjects|10 systemically healthy control subjects taking no medication.
43416|NCT02329600|O3|Outcome|OLP and Corticosteroid and Green Tea|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.~green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
43417|NCT02329600|O2|Outcome|OLP and Corticosteroid|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
43418|NCT02329600|O1|Outcome|Control Subjects|10 systemically healthy control subjects taking no medication.
43419|NCT02329600|E3|Reported Event|OLP and Corticosteroid and Green Tea|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.~green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
43420|NCT02329600|E2|Reported Event|OLP and Corticosteroid|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
43421|NCT02329600|E1|Reported Event|Control Subjects|10 systemically healthy control subjects taking no medication.
43422|NCT02329587|B3|Baseline|Total|Total of all reporting groups
43423|NCT02329587|B2|Baseline|ERP Plus Sham tDCS|"ERP plus sham tDCS of right inferior frontal gyrus~ERP plus sham tDCS: Participants in the ERP plus sham tDCS arm will receive an 11-session program, including 10 sessions which include both sham tDCS and ERP. During these sessions, 20 minutes of sham tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise."
43434|NCT02329587|O1|Outcome|ERP Plus tDCS|"ERP plus anodal tDCS of right inferior frontal gyrus~ERP plus tDCS: Participants in the ERP plus tDCS arm will receive an 11-session program, including 10 sessions which include both tDCS and ERP. During these sessions, 20 minutes of anodal tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise."
43435|NCT02329587|O2|Outcome|ERP Plus Sham tDCS|"ERP plus sham tDCS of right inferior frontal gyrus~ERP plus sham tDCS: Participants in the ERP plus sham tDCS arm will receive an 11-session program, including 10 sessions which include both sham tDCS and ERP. During these sessions, 20 minutes of sham tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise."
43436|NCT02329587|O1|Outcome|ERP Plus tDCS|"ERP plus anodal tDCS of right inferior frontal gyrus~ERP plus tDCS: Participants in the ERP plus tDCS arm will receive an 11-session program, including 10 sessions which include both tDCS and ERP. During these sessions, 20 minutes of anodal tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise."
43437|NCT02329587|O2|Outcome|ERP Plus Sham tDCS|"ERP plus sham tDCS of right inferior frontal gyrus~ERP plus sham tDCS: Participants in the ERP plus sham tDCS arm will receive an 11-session program, including 10 sessions which include both sham tDCS and ERP. During these sessions, 20 minutes of sham tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise."
43438|NCT02329587|O1|Outcome|ERP Plus tDCS|"ERP plus anodal tDCS of right inferior frontal gyrus~ERP plus tDCS: Participants in the ERP plus tDCS arm will receive an 11-session program, including 10 sessions which include both tDCS and ERP. During these sessions, 20 minutes of anodal tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise."
43439|NCT02329587|E2|Reported Event|ERP Plus Sham tDCS|"ERP plus sham tDCS of right inferior frontal gyrus~ERP plus sham tDCS: Participants in the ERP plus sham tDCS arm will receive an 11-session program, including 10 sessions which include both sham tDCS and ERP. During these sessions, 20 minutes of sham tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise."
43440|NCT02329587|E1|Reported Event|ERP Plus tDCS|"ERP plus anodal tDCS of right inferior frontal gyrus~ERP plus tDCS: Participants in the ERP plus tDCS arm will receive an 11-session program, including 10 sessions which include both tDCS and ERP. During these sessions, 20 minutes of anodal tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise."
43441|NCT02329431|B3|Baseline|Total|Total of all reporting groups
43442|NCT02329431|B2|Baseline|Support Group|"Parent-directed support group~support group: parent directed support group"
43443|NCT02329431|B1|Baseline|Activation Curriculum|"Psycho-social curriculum teaching activation skills~activation curriculum: psychosocial activation curriculum"
43444|NCT02329431|P2|Participant Flow|Support Group|"Parent-directed support group~support group: parent directed support group"
43445|NCT02329431|P1|Participant Flow|Activation Curriculum|"Psycho-social curriculum teaching activation skills~activation curriculum: psychosocial activation curriculum"
43446|NCT02329431|O2|Outcome|Support Group|"Parent-directed support group~support group: parent directed support group"
43447|NCT02329431|O1|Outcome|Activation Curriculum|"Psycho-social curriculum teaching activation skills~activation curriculum: psychosocial activation curriculum"
43448|NCT02329431|O2|Outcome|Support Group|"Parent-directed support group~support group: parent directed support group"
43449|NCT02329431|O1|Outcome|Activation Curriculum|"Psycho-social curriculum teaching activation skills~activation curriculum: psychosocial activation curriculum"
43450|NCT02329431|O2|Outcome|Support Group|"Parent-directed support group~support group: parent directed support group"
43451|NCT02329431|O1|Outcome|Activation Curriculum|"Psycho-social curriculum teaching activation skills~activation curriculum: psychosocial activation curriculum"
43452|NCT02329431|O2|Outcome|Support Group|"Parent-directed support group~support group: parent directed support group"
43453|NCT02329431|O1|Outcome|Activation Curriculum|"Psycho-social curriculum teaching activation skills~activation curriculum: psychosocial activation curriculum"
43454|NCT02329431|O2|Outcome|Support Group|"Parent-directed support group~support group: parent directed support group"
43455|NCT02329431|O1|Outcome|Activation Curriculum|"Psycho-social curriculum teaching activation skills~activation curriculum: psychosocial activation curriculum"
43456|NCT02329431|O2|Outcome|Support Group|"Parent-directed support group~support group: parent directed support group"
43457|NCT02329431|O1|Outcome|Activation Curriculum|"Psycho-social curriculum teaching activation skills~activation curriculum: psychosocial activation curriculum"
43458|NCT02329431|E2|Reported Event|Support Group|"Parent-directed support group~support group: parent directed support group"
43459|NCT02329431|E1|Reported Event|Activation Curriculum|"Psycho-social curriculum teaching activation skills~activation curriculum: psychosocial activation curriculum"
43460|NCT02329223|B4|Baseline|Total|Total of all reporting groups
43461|NCT02329223|B3|Baseline|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
43462|NCT02329223|B2|Baseline|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
43463|NCT02329223|B1|Baseline|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
43464|NCT02329223|P3|Participant Flow|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
43465|NCT02329223|P2|Participant Flow|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
43466|NCT02329223|P1|Participant Flow|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
43467|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
43468|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
43469|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
43470|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
43471|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
43482|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
43483|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
43484|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
43485|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
43486|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
43487|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
43488|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
43489|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
43490|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
43491|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
43492|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
43493|NCT02329223|E3|Reported Event|Placebo|Placebo
43494|NCT02329223|E2|Reported Event|IGE025 150 mg|IGE025 150 mg
43495|NCT02329223|E1|Reported Event|IGE025 300 mg|IGE025 300 mg
43496|NCT02329015|B3|Baseline|Total|Total of all reporting groups
43497|NCT02329015|B2|Baseline|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
43498|NCT02329015|B1|Baseline|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
43499|NCT02329015|P2|Participant Flow|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
43500|NCT02329015|P1|Participant Flow|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
43501|NCT02329015|O2|Outcome|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
43502|NCT02329015|O1|Outcome|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
43503|NCT02329015|O2|Outcome|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
43504|NCT02329015|O1|Outcome|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
43505|NCT02329015|O2|Outcome|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
43506|NCT02329015|O1|Outcome|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
43507|NCT02329015|O2|Outcome|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
43508|NCT02329015|O1|Outcome|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
43509|NCT02329015|O2|Outcome|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
43510|NCT02329015|O1|Outcome|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
43511|NCT02329015|O2|Outcome|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
43512|NCT02329015|O1|Outcome|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
43513|NCT02329015|E2|Reported Event|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
43514|NCT02329015|E1|Reported Event|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
43515|NCT02328937|B1|Baseline|Overall|All subjects that were dispensed at least one study lens.
43516|NCT02328937|P6|Participant Flow|Comfilcon A/Lotrafilcon B/Etafilcon A|Subjects randomized to this sequence received comfilcon A during the 1st period, then received lotrafilcon B during the 2nd period, and then received etafilcon A during the last period.
43517|NCT02328937|P5|Participant Flow|Comfilcon A/Etafilcon A/Lotrafilcon B|Subjects randomized to this sequence received comfilcon A during the 1st period, then received etafilcon A during the 2nd period, and then received lotrafilcon B during the last period.
43558|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
43518|NCT02328937|P4|Participant Flow|Lotrafilcon B/Comfilcon A/Etafilcon A|Subjects randomized to this sequence received lotrafilcon B during the 1st period, then received comfilcon A during the 2nd period, and then received etafilcon A during the last period.
43519|NCT02328937|P3|Participant Flow|Lotrafilcon B/Etafilcon A/Comfilcon A|Subjects randomized to this sequence received lotrafilcon B during the 1st period, then received etafilcon A during the 2nd period, and then received comfilcon A during the last period.
43520|NCT02328937|P2|Participant Flow|Etafilcon A/Comfilcon A/Lotrafilcon B|Subjects randomized to this sequence received etafilcon A during the 1st period, then received comfilcon A during the 2nd period, and then received lotrafilcon B during the last period.
43521|NCT02328937|P1|Participant Flow|Etafilcon A/Lotrafilcon B/Comfilcon A|Subjects randomized to this sequence received etafilcon A during the 1st period, then received lotrafilcon B during the 2nd period, and then received comfilcon A during the last period.
43522|NCT02328937|O3|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens during any of the 3 period over the course of this study.
43523|NCT02328937|O2|Outcome|Lotrafilcon B|Subjects that wore the lotrafilcon B lens during any of the 3 period over the course of this study.
43524|NCT02328937|O1|Outcome|Etafilcon A|Subjects that wore the etafilcon A lens during any of the 3 period over the course of this study.
43525|NCT02328937|O3|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens during any of the 3 period over the course of this study.
43526|NCT02328937|O2|Outcome|Lotrafilcon B|Subjects that wore the lotrafilcon B lens during any of the 3 period over the course of this study.
43527|NCT02328937|O1|Outcome|Etafilcon A|Subjects that wore the etafilcon A lens during any of the 3 period over the course of this study.
43528|NCT02328937|E3|Reported Event|Comfilcon A|Subjects that wore the comfilcon A lens during any of the 3 period over the course of this study.
43529|NCT02328937|E2|Reported Event|Lotrafilcon B|Subjects that wore the lotrafilcon B lens during any of the 3 period over the course of this study.
43530|NCT02328937|E1|Reported Event|Etafilcon A|Subjects that wore the etafilcon A lens during any of the 3 period over the course of this study.
43531|NCT02328404|B3|Baseline|Total|Total of all reporting groups
43532|NCT02328404|B2|Baseline|Placebo (Biodal 50,000IU Placebo)|"Placebo (Biodal 50,000IU Placebo tablets) coated tablets by oral route~Placebo: 50,000IU Vitamin D3 placebo (Biodal 50,000IU placebo) once weekly for 3 months"
43533|NCT02328404|B1|Baseline|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
43534|NCT02328404|P2|Participant Flow|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
43535|NCT02328404|P1|Participant Flow|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
43536|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
43537|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
43538|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
43539|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50.000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
43540|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
43541|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
43542|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
43543|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
43544|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
43545|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
43546|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo (Biodal 50,000 IU): 50.000IU Vitamin D3 (Biodal 50.000IU ) placebo once weekly for 3 months"
43547|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
43548|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
43549|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
43550|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
43551|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
43552|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
43553|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50.000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
43554|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
43555|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50.000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
43556|NCT02328404|O2|Outcome|Placebo|"Placebo coated tablet by oral route~Placebo: placebo coated tablet by oral route"
43557|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
43559|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
43560|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
43561|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
43562|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
43563|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
43564|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
43565|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
43566|NCT02328404|E2|Reported Event|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
43567|NCT02328404|E1|Reported Event|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
43568|NCT02327429|B1|Baseline|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study~A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
43569|NCT02327429|P1|Participant Flow|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study~A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
43570|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study~A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
43571|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study~A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
43572|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study~A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
43573|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study~A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
43574|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study~A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
43575|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study~A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
43576|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study~A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
43577|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study~A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
43578|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study~A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
43579|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study~A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
43580|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study~A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
43621|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43581|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study~A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
43582|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study~A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
43583|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study~A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
43584|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study~A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
43585|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study~A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
43586|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study~A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
43587|NCT02327429|E1|Reported Event|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study~A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
43588|NCT02327117|B3|Baseline|Total|Total of all reporting groups
43589|NCT02327117|B2|Baseline|Normal Saline|Normal saline
43590|NCT02327117|B1|Baseline|Tranexamic Acid|Tranexamic Acid
43591|NCT02327117|P2|Participant Flow|Normal Saline|Normal saline
43592|NCT02327117|P1|Participant Flow|Tranexamic Acid|Tranexamic Acid
43593|NCT02327117|O2|Outcome|Normal Saline|Normal saline
43594|NCT02327117|O1|Outcome|Tranexamic Acid|Tranexamic Acid
43595|NCT02327117|E2|Reported Event|Normal Saline|Normal saline
43596|NCT02327117|E1|Reported Event|Tranexamic Acid|Tranexamic Acid
43597|NCT02327013|B4|Baseline|Total|Total of all reporting groups
43598|NCT02327013|B3|Baseline|Vortioxetine 20mg (Stage 1)|Patients treated with vortioxetine 20mg in Stage 1.
43599|NCT02327013|B2|Baseline|Vortioxetine 10mg (Stage 1)|Patients treated with vortioxetine 10mg in Stage 1.
43600|NCT02327013|B1|Baseline|Placebo (Stage 1)|Patients treated wtih placebo in Stage 1.
43601|NCT02327013|P5|Participant Flow|Placebo - Vortioxetine 20mg|Patients that did not respond to placebo in Stage 1 and were re-randomized to treatment with vortioxetine 20mg/day in Stage 2.
43602|NCT02327013|P4|Participant Flow|Placebo - Vortioxetine 10mg|Patients that did not respond to placebo in Stage 1 and were re-randomized to treatment with vortioxetine 10mg/day in Stage 2.
43603|NCT02327013|P3|Participant Flow|Placebo - Placebo|Patients randomized to treatment with placebo in Stage 1 and continued on the same treatment in Stage 2. This group will consist of placebo responders and placebo non-responders who were re-randomized to Placebo in Stage 2.
43604|NCT02327013|P2|Participant Flow|Vortioxetine 20mg|Patients randomized to treatment with vortioxetine 20mg/day in Stage 1 and continued on the same treatment in Stage 2.
43605|NCT02327013|P1|Participant Flow|Vortioxetine 10mg|Patients randomized to treatment with vortioxetine 10mg/day in Stage 1 and continued on the same treatment in Stage 2.
43606|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43607|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43608|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43609|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43610|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43611|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43612|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43613|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43614|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43615|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43616|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43617|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43618|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43619|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43620|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43622|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43623|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43624|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43625|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43626|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43627|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43628|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43629|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43630|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43631|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43632|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43633|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43634|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43635|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43636|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43637|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43638|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43639|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43640|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43641|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43642|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43643|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43644|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43645|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43646|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43647|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43648|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43649|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43650|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43651|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43652|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43653|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43654|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43655|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43656|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43657|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43658|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43659|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43660|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43661|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43662|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43663|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43664|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43665|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43666|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43667|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43668|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43669|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43670|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43671|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43672|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43673|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43674|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43675|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43676|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43677|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43678|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43679|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43680|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43681|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43682|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43683|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43684|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43685|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43686|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43687|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43688|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43689|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43690|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43691|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43692|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43693|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43694|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43695|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43696|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43697|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43698|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43699|NCT02327013|O3|Outcome|Vortioxetine 20mg, Stage 1|Data from patients treated with vortioxetine 20mg in Stage 1
43700|NCT02327013|O2|Outcome|Vortioxetine 10mg, Stage 1|Data from patients treated with vortioxetine 10mg in Stage 1
43701|NCT02327013|O1|Outcome|Placebo, Stage 1|Data from patients treated with placebo in Stage
43702|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43703|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43704|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43705|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43706|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43707|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43708|NCT02327013|O3|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43709|NCT02327013|O2|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43710|NCT02327013|O1|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43711|NCT02327013|O9|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43712|NCT02327013|O8|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43713|NCT02327013|O7|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43714|NCT02327013|O6|Outcome|Vortioxetine 20mg, Stage 2|Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
43715|NCT02327013|O5|Outcome|Vortioxetine 10mg, Stage 2|Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
43716|NCT02327013|O4|Outcome|Placebo, Stage 2|Placebo responders from Stage 1 continue on placebo in Stage 2.
43717|NCT02327013|O3|Outcome|Vortioxetine 20mg, Stage 1|Patients treated with vortioxetine 20mg in Stage 1.
43718|NCT02327013|O2|Outcome|Vortioxetine 10mg, Stage 1|Patients treated with vortioxetine 10mg in Stage 1.
43719|NCT02327013|O1|Outcome|Placebo, Stage 1|Patients treated with placebo in Stage 1.
43720|NCT02327013|O9|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43721|NCT02327013|O8|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43722|NCT02327013|O7|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43723|NCT02327013|O6|Outcome|Vortioxetine 20mg, Stage 2|Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
43724|NCT02327013|O5|Outcome|Vortioxetine 10mg, Stage 2|Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
43725|NCT02327013|O4|Outcome|Placebo, Stage 2|Placebo responders from Stage 1 continue on placebo in Stage 2.
67811|NCT02153489|O2|Outcome|Placebo|Placebo BID
43726|NCT02327013|O3|Outcome|Vortioxetine 20mg, Stage 1|Patients treated with vortioxetine 20mg in Stage 1.
43727|NCT02327013|O2|Outcome|Vortioxetine 10mg, Stage 1|Patients treated with vortioxetine 10mg in Stage 1.
43728|NCT02327013|O1|Outcome|Placebo, Stage 1|Patients treated with placebo in Stage 1.
43729|NCT02327013|O9|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43730|NCT02327013|O8|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43731|NCT02327013|O7|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43732|NCT02327013|O6|Outcome|Vortioxetine 20mg, Stage 2|Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
43733|NCT02327013|O5|Outcome|Vortioxetine 10mg, Stage 2|Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
43734|NCT02327013|O4|Outcome|Placebo, Stage 2|Placebo responders from Stage 1 continue on placebo in Stage 2.
43735|NCT02327013|O3|Outcome|Vortioxetine 20mg, Stage 1|Patients treated with vortioxetine 20mg in Stage 1.
43736|NCT02327013|O2|Outcome|Vortioxetine 10mg, Stage 1|Patients treated with vortioxetine 10mg in Stage 1.
43737|NCT02327013|O1|Outcome|Placebo, Stage 1|Patients treated with placebo in Stage 1.
43738|NCT02327013|O9|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43739|NCT02327013|O8|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43740|NCT02327013|O7|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43741|NCT02327013|O6|Outcome|Vortioxetine 20mg, Stage 2|Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
43742|NCT02327013|O5|Outcome|Vortioxetine 10mg, Stage 2|Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
43743|NCT02327013|O4|Outcome|Placebo, Stage 2|Placebo responders from Stage 1 continue on placebo in Stage 2.
43744|NCT02327013|O3|Outcome|Vortioxetine 20mg, Stage 1|Patients treated with vortioxetine 20mg in Stage 1.
43745|NCT02327013|O2|Outcome|Vortioxetine 10mg, Stage 1|Patients treated with vortioxetine 10mg in Stage 1.
43746|NCT02327013|O1|Outcome|Placebo, Stage 1|Patients treated with placebo in Stage 1.
43747|NCT02327013|O9|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43748|NCT02327013|O8|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43749|NCT02327013|O7|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43750|NCT02327013|O6|Outcome|Vortioxetine 20mg, Stage 2|Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
43751|NCT02327013|O5|Outcome|Vortioxetine 10mg, Stage 2|Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
43752|NCT02327013|O4|Outcome|Placebo, Stage 2|Placebo responders from Stage 1 continue on placebo in Stage 2.
43753|NCT02327013|O3|Outcome|Vortioxetine 20mg, Stage 1|Patients treated with vortioxetine 20mg in Stage 1.
43754|NCT02327013|O2|Outcome|Vortioxetine 10mg, Stage 1|Patients treated with vortioxetine 10mg in Stage 1.
43755|NCT02327013|O1|Outcome|Placebo, Stage 1|Patients treated with placebo in Stage 1.
43756|NCT02327013|O9|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43757|NCT02327013|O8|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43758|NCT02327013|O7|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43759|NCT02327013|O6|Outcome|Vortioxetine 20mg, Stage 2|Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
43760|NCT02327013|O5|Outcome|Vortioxetine 10mg, Stage 2|Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
43761|NCT02327013|O4|Outcome|Placebo, Stage 2|Placebo responders from Stage 1 continue on placebo in Stage 2.
43762|NCT02327013|O3|Outcome|Vortioxetine 20mg, Stage 1|Patients treated with vortioxetine 20mg in Stage 1.
43763|NCT02327013|O2|Outcome|Vortioxetine 10mg, Stage 1|Patients treated with vortioxetine 10mg in Stage 1.
43764|NCT02327013|O1|Outcome|Placebo, Stage 1|Patients treated with placebo in Stage 1.
43765|NCT02327013|O9|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
43766|NCT02327013|O8|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
43767|NCT02327013|O7|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
43768|NCT02327013|O6|Outcome|Vortioxetine 20mg, Stage 2|Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
43769|NCT02327013|O5|Outcome|Vortioxetine 10mg, Stage 2|Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
43770|NCT02327013|O4|Outcome|Placebo, Stage 2|Placebo responders from Stage 1 continue on placebo in Stage 2.
43771|NCT02327013|O3|Outcome|Vortioxetine 20mg, Stage 1|Patients treated with vortioxetine 20mg in Stage 1.
43772|NCT02327013|O2|Outcome|Vortioxetine 10mg, Stage 1|Patients treated with vortioxetine 10mg in Stage 1.
43773|NCT02327013|O1|Outcome|Placebo, Stage 1|Patients treated with placebo in Stage 1.
43774|NCT02327013|E3|Reported Event|Vortioxetine 20mg|Patients randomized to treatment with vortioxetine 20mg/day in Stage 1 and continued on the same treatment in Stage 2. In addition, patients that did not respond to placebo in Stage 1 and were re-randomized to treatment with vortioxetine 20mg/day in Stage 2. This group consists of patients who had received dosing of 20 mg vortioxetine in the study.
43775|NCT02327013|E2|Reported Event|Vortioxetine 10mg|Patients randomized to treatment with vortioxetine 10mg/day in Stage 1 and continued on the same treatment in Stage 2. In addition, patients that did not respond to placebo in Stage 1 and were re-randomized to treatment with vortioxetine 10mg/day in Stage 2.This group consists of patients who had received dosing of 10 mg vortioxetine in the study.
43776|NCT02327013|E1|Reported Event|Placebo-Placebo|Patients randomized to treatment with placebo in Stage 1 and continued on the same treatment in Stage 2. This group consists of placebo responders and placebo non-responders who were re-randomized to Placebo in Stage 2.
43777|NCT02326844|B1|Baseline|Ovarian Cancer Patients|Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
43778|NCT02326844|P1|Participant Flow|Ovarian Cancer Patients|Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
43779|NCT02326844|O1|Outcome|Ovarian Cancer Patients|Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
43780|NCT02326844|O1|Outcome|Ovarian Cancer Patients|Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
43781|NCT02326844|O1|Outcome|Ovarian Cancer Patients|Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
43782|NCT02326844|O1|Outcome|Ovarian Cancer Patients|Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
43783|NCT02326844|E1|Reported Event|Ovarian Cancer Patients|Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
43784|NCT02326649|B1|Baseline|Diagnosis, Age, and Body Size of Subjects|Overall
43785|NCT02326649|P1|Participant Flow|SMIC and CMR|Participants with various congenital heart disease diagnoses with both signal-morphology IC (SMIC) measurements and cardiac magnetic resonance (CMR) imaging
43786|NCT02326649|O1|Outcome|SMIC and CMR|Participants with various congenital heart disease diagnoses with both signal-morphology IC (SMIC) measurements and cardiac magnetic resonance (CMR) imaging
43787|NCT02326649|E1|Reported Event|CHD Patients Undergoing Cardiac MRI Without Sedation|Physioflow: impedance cardiography instrument that measures cardiac output non-invasively
43788|NCT02325856|B3|Baseline|Total|Total of all reporting groups
43789|NCT02325856|B2|Baseline|Control Group|Dry weight determined by clinical symptoms
43790|NCT02325856|B1|Baseline|Study Group|"Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)~Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients."
43791|NCT02325856|P2|Participant Flow|Control Group|Dry weight determined by clinical symptoms
43792|NCT02325856|P1|Participant Flow|Study Group|"Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)~Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients."
43793|NCT02325856|O2|Outcome|Control Group|Dry weight determined by clinical symptoms
43794|NCT02325856|O1|Outcome|Study Group|"Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)~Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients."
43795|NCT02325856|O2|Outcome|Control Group|Dry weight determined by clinical symptoms
43796|NCT02325856|O1|Outcome|Study Group|"Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)~Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients."
43797|NCT02325856|E2|Reported Event|Control Group|Dry weight determined by clinical symptoms
43798|NCT02325856|E1|Reported Event|Study Group|"Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)~Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients."
43799|NCT02325713|B17|Baseline|Total|Total of all reporting groups
43800|NCT02325713|B16|Baseline|Sequence B-A-D2-C2|Subjects randomized to treatment sequence B-A-D2-C2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43801|NCT02325713|B15|Baseline|Sequence B-A-D1-C2|Subjects randomized to treatment sequence B-A-D1-C2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43832|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
43833|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
44131|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
43802|NCT02325713|B14|Baseline|Sequence B-A-D2-C1|Subjects randomized to treatment sequence B-A-D2-C1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43803|NCT02325713|B13|Baseline|Sequence B-A-D1-C1|Subjects randomized to treatment sequence B-A-D1-C1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43804|NCT02325713|B12|Baseline|Sequence B-A-C2-D2|Subjects randomized to treatment sequence B-A-C2-D2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43805|NCT02325713|B11|Baseline|Sequence B-A-C2-D1|Subjects randomized to treatment sequence B-A-C2-D1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43806|NCT02325713|B10|Baseline|Sequence B-A-C1-D2|Subjects randomized to treatment sequence B-A-C1-D2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43807|NCT02325713|B9|Baseline|Sequence B-A-C1-D1|Subjects randomized to treatment sequence B-A-C1-D1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43808|NCT02325713|B8|Baseline|Sequence A-B-D2-C2|Subjects randomized to treatment sequence A-B-D2-C2 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43809|NCT02325713|B7|Baseline|Sequence A-B-D1-C2|Subjects randomized to treatment sequence A-B-D1-C2 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43810|NCT02325713|B6|Baseline|Sequence A-B-D2-C1|Subjects randomized to treatment sequence A-B-D2-C1 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43811|NCT02325713|B5|Baseline|Sequence A-B-D1-C1|Subjects randomized to treatment sequence A-B-D1-C1 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43834|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43812|NCT02325713|B4|Baseline|Sequence A-B-C2-D2|Subjects randomized to treatment sequence A-B-C2-D2 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43813|NCT02325713|B3|Baseline|Sequence A-B-C2-D1|Subjects randomized to treatment sequence A-B-C2-D1 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43814|NCT02325713|B2|Baseline|Sequence A-B-C1-D2|Subjects randomized to treatment sequence A-B-C1-D2 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43815|NCT02325713|B1|Baseline|Sequence A-B-C1-D1|Subjects randomized to treatment sequence A-B-C1-D1 received a single oral dose of 40 milligram per kilogram (40 mg/kg) of test oral dispersible tablet of praziquantel (ODT-PZQ) dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43816|NCT02325713|P16|Participant Flow|Sequence B-A-D2-C2|Subjects randomized to treatment sequence B-A-D2-C2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43817|NCT02325713|P15|Participant Flow|Sequence B-A-D1-C2|Subjects randomized to treatment sequence B-A-D1-C2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43818|NCT02325713|P14|Participant Flow|Sequence B-A-D2-C1|Subjects randomized to treatment sequence B-A-D2-C1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43819|NCT02325713|P13|Participant Flow|Sequence B-A-D1-C1|Subjects randomized to treatment sequence B-A-D1-C1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43820|NCT02325713|P12|Participant Flow|Sequence B-A-C2-D2|Subjects randomized to treatment sequence B-A-C2-D2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43821|NCT02325713|P11|Participant Flow|Sequence B-A-C2-D1|Subjects randomized to treatment sequence B-A-C2-D1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
44122|NCT02322788|E1|Reported Event|M2 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M2
43822|NCT02325713|P10|Participant Flow|Sequence B-A-C1-D2|Subjects randomized to treatment sequence B-A-C1-D2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43823|NCT02325713|P9|Participant Flow|Sequence B-A-C1-D1|Subjects randomized to treatment sequence B-A-C1-D1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43824|NCT02325713|P8|Participant Flow|Sequence A-B-D2-C2|Subjects randomized to treatment sequence A-B-D2-C2 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43825|NCT02325713|P7|Participant Flow|Sequence A-B-D1-C2|Subjects randomized to treatment sequence A-B-D1-C2 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43826|NCT02325713|P6|Participant Flow|Sequence A-B-D2-C1|Subjects randomized to treatment sequence A-B-D2-C1 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43827|NCT02325713|P5|Participant Flow|Sequence A-B-D1-C1|Subjects randomized to treatment sequence A-B-D1-C1 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43828|NCT02325713|P4|Participant Flow|Sequence A-B-C2-D2|Subjects randomized to treatment sequence A-B-C2-D2 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43829|NCT02325713|P3|Participant Flow|Sequence A-B-C2-D1|Subjects randomized to treatment sequence A-B-C2-D1 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43830|NCT02325713|P2|Participant Flow|Sequence A-B-C1-D2|Subjects randomized to treatment sequence A-B-C1-D2 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
43831|NCT02325713|P1|Participant Flow|Sequence A-B-C1-D1|Subjects randomized to treatment sequence A-B-C1-D1 received a single oral dose of 40 milligram per kilogram (40 mg/kg) of test oral dispersible tablet of praziquantel (ODT-PZQ) dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
44123|NCT02322775|B3|Baseline|Total|Total of all reporting groups
43835|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43836|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
43837|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43838|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
43839|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
43840|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43841|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43842|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
43843|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43844|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
43845|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
43846|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43847|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43848|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
43849|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43850|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
43851|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
43852|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43853|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43854|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
43855|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43856|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
43857|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
43858|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43859|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43860|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
43861|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43862|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
43863|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
43864|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
67812|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
43865|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43866|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
43867|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43868|NCT02325713|O1|Outcome|PZQ 40 mg/kg (Treatment A and Treatment B)|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal and reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
43869|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
43870|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
43871|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43872|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43873|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
43874|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43875|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
43876|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
43877|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43878|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43879|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
43880|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43881|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
43882|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
43883|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43884|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43885|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
43886|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43887|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
43888|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
43889|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43890|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43891|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
43892|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43893|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
43894|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
43895|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43896|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43897|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
43898|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43899|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
43900|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
43901|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43902|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43903|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
43904|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43905|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
43906|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
43907|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43908|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43909|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
43910|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43911|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
43912|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
43913|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43914|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43915|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
43916|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43917|NCT02325713|E6|Reported Event|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
43918|NCT02325713|E5|Reported Event|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
43919|NCT02325713|E4|Reported Event|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43920|NCT02325713|E3|Reported Event|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43921|NCT02325713|E2|Reported Event|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
43922|NCT02325713|E1|Reported Event|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
43923|NCT02325518|B3|Baseline|Total|Total of all reporting groups
43924|NCT02325518|B2|Baseline|DOR/TIM|Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
43925|NCT02325518|B1|Baseline|BRI/TIM|Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
43926|NCT02325518|P2|Participant Flow|DOR/TIM|Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
43927|NCT02325518|P1|Participant Flow|BRI/TIM|Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual prostaglandin-analog (PGA) monotherapy, 1 drop in each eye once daily for 8 weeks.
43928|NCT02325518|O2|Outcome|DOR/TIM|Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
43929|NCT02325518|O1|Outcome|BRI/TIM|Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
43930|NCT02325518|O2|Outcome|DOR/TIM|Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
43931|NCT02325518|O1|Outcome|BRI/TIM|Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
43932|NCT02325518|E3|Reported Event|DOR/TIM|Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
43933|NCT02325518|E2|Reported Event|BRI/TIM|Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
43934|NCT02325518|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
43935|NCT02324673|B4|Baseline|Total|Total of all reporting groups
43936|NCT02324673|B3|Baseline|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
43937|NCT02324673|B2|Baseline|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
43938|NCT02324673|B1|Baseline|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
43939|NCT02324673|P3|Participant Flow|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
43940|NCT02324673|P2|Participant Flow|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
43941|NCT02324673|P1|Participant Flow|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
43942|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
43943|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
43944|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
43945|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
43946|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
43947|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
43948|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
43949|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
43950|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
44124|NCT02322775|B2|Baseline|Placebo|Placebo administered subcutaneously every 4 weeks
43951|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
43952|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
43953|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
43954|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
43955|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
43956|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
43957|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
43958|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
43959|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
43960|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
43961|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
43962|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
43963|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
43964|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
43965|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
43966|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
43967|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
43968|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
43969|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
43970|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
43971|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
44125|NCT02322775|B1|Baseline|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
43972|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
43973|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
43974|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
43975|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
43976|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
43977|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
43978|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
43979|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
43980|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
43981|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
43982|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
43983|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
43984|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
43985|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
43986|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
43987|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
43988|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
43989|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
43990|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
43991|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
43992|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
44126|NCT02322775|P2|Participant Flow|Placebo|Placebo administered subcutaneously every 4 weeks
43993|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
43994|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
43995|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
43996|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
43997|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
43998|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
43999|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
44000|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
44001|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
44002|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
44003|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
44004|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
44005|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
44006|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
44007|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
44008|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
44009|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
44010|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
44011|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
44012|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
44013|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
44127|NCT02322775|P1|Participant Flow|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
44014|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
44015|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
44016|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
44017|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
44018|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
44019|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
44020|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
44021|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
44022|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
44023|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
44024|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
44025|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
44026|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
44027|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
44028|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
44029|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
44030|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
44031|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
44032|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
44033|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
44034|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
44128|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
44035|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
44036|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
44037|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
44038|NCT02324673|E3|Reported Event|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
44039|NCT02324673|E2|Reported Event|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
44040|NCT02324673|E1|Reported Event|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
44041|NCT02324660|B1|Baseline|Patients Undergoing Screening and Spirometry|
44042|NCT02324660|P1|Participant Flow|Patients Undergoing Screening and Spirometry|From December 2014 to August 2015, 169 ACS patients with smoking history underwent screening procedure. Screening procedure combined peak expiratory flow rate (PEFR, defined as positive if <80% of predicted) and respiratory health status questionnaire (RHSQ, defined as positive if >19.5 points). Overall, 137 (81%) patients received spirometry (final study population)
44043|NCT02324660|O1|Outcome|Screening Test|"all consecutive patients admitted to our hospital for ACS and current/former smokers will be screened according our protocol with PEF and RHSQ. Patients will be blinded to result of both tests. Indipendently to results, all included patients will receive spirometry (50-70 days after inclusion) to assess the presence or not of COPD (primary outcome).~screening test: screening test with peak expiratory flow and respiratory health screening questionnaire to discriminate patients at risk for COPD"
44044|NCT02324660|O1|Outcome|Patients Undergoing Screening and Spirometry|From December 2014 to August 2015, 169 ACS patients with smoking history underwent screening procedure. Screening procedure combined peak expiratory flow rate (PEFR, defined as positive if <80% of predicted) and respiratory health status questionnaire (RHSQ, defined as positive if >19.5 points). Overall, 137 (81%) patients received spirometry (final study population)
44045|NCT02324660|E1|Reported Event|Patients Undergoing Screening and Spirometry|From December 2014 to August 2015, 169 ACS patients with smoking history underwent screening procedure. Screening procedure combined peak expiratory flow rate (PEFR, defined as positive if <80% of predicted) and respiratory health status questionnaire (RHSQ, defined as positive if >19.5 points). Overall, 137 (81%) patients received spirometry (final study population)
44046|NCT02324504|B1|Baseline|Intervention|"Subjects will have their central catheters placed with the assistance of the FDA approved C3 Wave PICC Tip Confirmation System which will assist with location of the catheter tip in real-time, during the procedure.~C3 Wave ECG-based PICC Tip Confirmation System: The C3 Wave PICC tip detection system will be used to identify catheter tip location during the procedural placement of the catheter. This system includes an ECG monitor that will be connected to the guidewire used for catheter placement. The changes in the ECG tracing will guide correct catheter placement.~Chest radiograph: Chest radiograph will be performed as a second measure to confirm catheter tip placement."
44047|NCT02324504|P1|Participant Flow|Intervention|"Subjects will have their central catheters placed with the assistance of the FDA approved C3 Wave PICC Tip Confirmation System which will assist with location of the catheter tip in real-time, during the procedure.~C3 Wave ECG-based PICC Tip Confirmation System: The C3 Wave PICC tip detection system will be used to identify catheter tip location during the procedural placement of the catheter. This system includes an ECG monitor that will connected to the guidewire used for catheter placement. The changes in the ECG tracing will guide correct catheter placement. Standard care chest radiograph will be performed as a second measure to confirm catheter tip placement."
44048|NCT02324504|O4|Outcome|Subjects Age 12-17 Years of Age|Approximately 38% of the enrolled subjects were between 12 and 17 years of age. In all three groups PICC placement will be guided by the C3 Wave device in order to determine if success rates, overall and by age group, are greater than local historical success rates.
44049|NCT02324504|O3|Outcome|Subjects Age 3-11 Years of Age|Approximately 23% of the enrolled subjects were between the ages of 3 and 11 years. In all three groups PICC placement will be guided by the C3 Wave device in order to determine if success rates, overall and by age group, are greater than local historical success rates.
44050|NCT02324504|O2|Outcome|Subjects Age 0-2 Years of Age|Approximately 38% of the enrolled subjects were two years of age or younger. In all three groups PICC placement will be guided by the C3 Wave device in order to determine if success rates, overall and by age group, are greater than local historical success rates.
44051|NCT02324504|O1|Outcome|Total Enrolllment|All subjects (less than 18 years of age) will have PICC placement guided by the C3 Wave device in order to determine if success rates, overall and by age group, are greater than local historical success rates.
44052|NCT02324504|E1|Reported Event|Intervention|"Subjects will have their central catheters placed with the assistance of the FDA approved C3 Wave PICC Tip Confirmation System which will assist with location of the catheter tip in real-time, during the procedure.~C3 Wave ECG-based PICC Tip Confirmation System: The C3 Wave PICC tip detection system will be used to identify catheter tip location during the procedural placement of the catheter. This system includes an ECG monitor that will connected to the guidewire used for catheter placement. The changes in the ECG tracing will guide correct catheter placement.~Chest radiograph: Chest radiograph will be performed as a second measure to confirm catheter tip placement."
44053|NCT02323854|B1|Baseline|Ablation and Surgical Resection|"All subjects meeting the inclusion/exclusion criteria were enrolled into the study to receive microwave ablation from the Emprint™ Ablation System using a percutaneous approach in patients with metastatic or primary lung tumors.~Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.~Once the ablation procedure was completed, the scheduled surgical tumor resection was performed. Adverse event data were collected starting from the initial administration of anesthesia until conclusion of the first post-operative follow-up visit."
44054|NCT02323854|P1|Participant Flow|Ablation and Surgical Resection|"All subjects meeting the inclusion/exclusion criteria were enrolled into the study to receive microwave ablation from the Emprint™ Ablation System using a percutaneous approach in patients with metastatic or primary lung tumors.~Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.~Once the ablation procedure was completed, the scheduled surgical tumor resection was performed. Adverse event data was collected starting from the initial administration of anesthesia until conclusion of the first post-operative follow-up visit."
44055|NCT02323854|O1|Outcome|Ablation and Surgical Resection|"All subjects meeting the inclusion/exclusion criteria were enrolled into the study to receive microwave ablation from the Emprint™ Ablation System using a percutaneous approach in patients with metastatic or primary lung tumors.~Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.~Once the ablation procedure was completed, the scheduled surgical tumor resection was performed. Adverse event data were collected starting from the initial administration of anesthesia until conclusion of the first post-operative follow-up visit."
44056|NCT02323854|O1|Outcome|Ablation and Surgical Resection|"All subjects meeting the inclusion/exclusion criteria were enrolled into the study to receive microwave ablation from the Emprint™ Ablation System using a percutaneous approach in patients with metastatic or primary lung tumors.~Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.~Once the ablation procedure was completed, the scheduled surgical tumor resection was performed. Adverse event data were collected starting from the initial administration of anesthesia until conclusion of the first post-operative follow-up visit."
44057|NCT02323854|O1|Outcome|Ablation and Surgical Resection|"All subjects meeting the inclusion/exclusion criteria were enrolled into the study to receive microwave ablation from the Emprint™ Ablation System using a percutaneous approach in patients with metastatic or primary lung tumors.~Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.~Once the ablation procedure was completed, the scheduled surgical tumor resection was performed. Adverse event data were collected starting from the initial administration of anesthesia until conclusion of the first post-operative follow-up visit."
44058|NCT02323854|E1|Reported Event|Ablation and Surgical Resection|"All subjects meeting the inclusion/exclusion criteria were enrolled into the study to receive microwave ablation from the Emprint™ Ablation System using a percutaneous approach in patients with metastatic or primary lung tumors.~Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.~Once the ablation procedure was completed, the scheduled surgical tumor resection was performed. Adverse event data were collected starting from the initial administration of anesthesia until conclusion of the first post-operative follow-up visit."
44059|NCT02322892|B3|Baseline|Total|Total of all reporting groups
44060|NCT02322892|B2|Baseline|Thiamine|"200 mg thiamine in 50 mL normal saline solution~Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
44061|NCT02322892|B1|Baseline|Control Arm|"50 mL normal saline solution~Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
44062|NCT02322892|P2|Participant Flow|Thiamine|"200 mg thiamine in 50 mL normal saline solution~Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
44063|NCT02322892|P1|Participant Flow|Control Arm|"50 mL normal saline solution~Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
44064|NCT02322892|O2|Outcome|Thiamine|"200 mg thiamine in 50 mL normal saline solution~Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
44065|NCT02322892|O1|Outcome|Control Arm|"50 mL normal saline solution~Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
44066|NCT02322892|O2|Outcome|Thiamine|"200 mg thiamine in 50 mL normal saline solution~Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
44067|NCT02322892|O1|Outcome|Control Arm|"50 mL normal saline solution~Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
44068|NCT02322892|O2|Outcome|Thiamine|"200 mg thiamine in 50 mL normal saline solution~Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
44069|NCT02322892|O1|Outcome|Control Arm|"50 mL normal saline solution~Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
44070|NCT02322892|O2|Outcome|Thiamine|"200 mg thiamine in 50 mL normal saline solution~Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
44071|NCT02322892|O1|Outcome|Control Arm|"50 mL normal saline solution~Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
44072|NCT02322892|O2|Outcome|Thiamine|"200 mg thiamine in 50 mL normal saline solution~Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
44073|NCT02322892|O1|Outcome|Control Arm|"50 mL normal saline solution~Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
44129|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
44074|NCT02322892|E2|Reported Event|Thiamine|"200 mg thiamine in 50 mL normal saline solution~Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
44075|NCT02322892|E1|Reported Event|Control Arm|"50 mL normal saline solution~Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
44076|NCT02322879|B3|Baseline|Total|Total of all reporting groups
44077|NCT02322879|B2|Baseline|Acetaminophen + Propylene Glycol First, Then Acetaminophen|"Participants in this arm received 4 grams of solid acetaminophen formulation in addition to 70 mg/kg/day of liquid propylene glycol for two weeks, followed by a two week wash out period.~Then, subjects received 4 grams of solid acetaminophen formulation for two weeks."
44078|NCT02322879|B1|Baseline|Acetaminophen First, Then Acetaminophen + Propylene Glycol|"Participants in this arm received 4 grams of solid acetaminophen formulation for two weeks, followed by a two week wash out period.~Then, subjects received 4 grams of solid acetaminophen formulation in addition to 70 mg/kg/day of liquid propylene glycol for two weeks."
44079|NCT02322879|P2|Participant Flow|Acetaminophen + Propylene Glycol First, Then Acetaminophen|"Participants in this arm received 4 grams of solid acetaminophen formulation in addition to 70 mg/kg/day of liquid propylene glycol for two weeks, followed by a two week wash out period.~Then, subjects received 4 grams of solid acetaminophen formulation for two weeks."
44080|NCT02322879|P1|Participant Flow|Acetaminophen First, Then Acetaminophen + Propylene Glycol|"Participants in this arm received 4 grams of solid acetaminophen formulation for two weeks, followed by a two week wash out period.~Then, subjects received 4 grams of solid acetaminophen formulation in addition to 70 mg/kg/day of liquid propylene glycol for two weeks."
44081|NCT02322879|O2|Outcome|Acetaminophen + Propylene Glycol|Participants received 4 grams of solid acetaminophen formulation in addition to 70 mg/kg/day of liquid propylene glycol for two weeks
44082|NCT02322879|O1|Outcome|Acetaminophen|Participants received 4 grams of solid acetaminophen formulation for two weeks
44083|NCT02322879|E2|Reported Event|Acetaminophen + Propylene Glycol|Participants received 4 grams of solid acetaminophen formulation in addition to 70 mg/kg/day of liquid propylene glycol for two weeks.
44084|NCT02322879|E1|Reported Event|Acetaminophen|Participants received 4 grams of solid acetaminophen formulation for two weeks.
44085|NCT02322866|B3|Baseline|Total|Total of all reporting groups
44086|NCT02322866|B2|Baseline|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44087|NCT02322866|B1|Baseline|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44088|NCT02322866|P2|Participant Flow|Sarecycline|Sarecycline tablets, 1.5 milligram(mg)/kilogram(kg)/day, taken orally once daily for 12 weeks.
44089|NCT02322866|P1|Participant Flow|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44090|NCT02322866|O2|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44091|NCT02322866|O1|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44092|NCT02322866|O2|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44093|NCT02322866|O1|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44094|NCT02322866|O2|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44095|NCT02322866|O1|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44096|NCT02322866|O2|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44097|NCT02322866|O1|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44098|NCT02322866|O2|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44099|NCT02322866|O1|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44100|NCT02322866|O2|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44101|NCT02322866|O1|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44102|NCT02322866|O2|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44103|NCT02322866|O1|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44104|NCT02322866|O2|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44105|NCT02322866|O1|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44106|NCT02322866|O2|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44107|NCT02322866|O1|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44108|NCT02322866|E2|Reported Event|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44109|NCT02322866|E1|Reported Event|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44110|NCT02322788|B1|Baseline|Overall|Total number of participants in the Full analysis set
44111|NCT02322788|P4|Participant Flow|M3 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M3
44112|NCT02322788|P3|Participant Flow|M3 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M3
44113|NCT02322788|P2|Participant Flow|M2 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M2
44114|NCT02322788|P1|Participant Flow|M2 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M2
44115|NCT02322788|O4|Outcome|M2 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M2
44116|NCT02322788|O3|Outcome|M2 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M2
44117|NCT02322788|O2|Outcome|M3 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M3
44118|NCT02322788|O1|Outcome|M3 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M3
44119|NCT02322788|E4|Reported Event|M3 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M3
44120|NCT02322788|E3|Reported Event|M3 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M3
44121|NCT02322788|E2|Reported Event|M2 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M2
44133|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
44134|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
44135|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
44136|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
44137|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
44138|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
44139|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
44140|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
44141|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
44142|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
44143|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
44144|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
44145|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
44146|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
44147|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
44148|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
44149|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
44150|NCT02322775|E2|Reported Event|Placebo|Placebo administered subcutaneously every 4 weeks
44151|NCT02322775|E1|Reported Event|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
44152|NCT02322749|B1|Baseline|Overall Study|All subjects received at least 1 dose of selumetinib. Subjects were randomised in a crossover fashion to receive 1 of 3 treatments during each treatment period: Period 1=Visit 2; Period 2=Visit 3; Period 3=Visit 4.
44153|NCT02322749|P6|Participant Flow|Sequence CBA|Subjects randomized to treatment sequences CBA: C=Selumetinib Blue TPGS Variant Capsules; B=Selumetinib Blue Free Base Variant Capsules; A=Selumetinib Blue Reference Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
44154|NCT02322749|P5|Participant Flow|Sequence CAB|Subjects randomized to treatment sequences CAB: C=Selumetinib Blue TPGS Variant Capsules; A=Selumetinib Blue Reference Capsules; B=Selumetinib Blue Free Base Variant Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
44155|NCT02322749|P4|Participant Flow|Sequence BCA|Subjects randomized to treatment sequences BCA: B=Selumetinib Blue Free Base Variant Capsules; C=Selumetinib Blue TPGS Variant Capsules; A=Selumetinib Blue Reference Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
44156|NCT02322749|P3|Participant Flow|Sequence BAC|Subjects randomized to treatment sequences BAC: B=Selumetinib Blue Free Base Variant Capsules; A=Selumetinib Blue Reference Capsules; C=Selumetinib Blue TPGS Variant Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
44157|NCT02322749|P2|Participant Flow|Sequence ACB|Subjects randomized to treatment sequences ACB: A=Selumetinib Blue Reference Capsules; C=Selumetinib Blue TPGS Variant Capsules; B=Selumetinib Blue Free Base Variant Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
44158|NCT02322749|P1|Participant Flow|Sequence ABC|Subjects randomized to treatment sequences ABC: A=Selumetinib Blue Reference Capsules; B=Selumetinib Blue Free Base Variant Capsules; C=Selumetinib Blue TPGS Variant Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
44159|NCT02322749|O3|Outcome|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
44160|NCT02322749|O2|Outcome|Treatment B: Selumetinib Blue Free Base Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
44161|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
44162|NCT02322749|O3|Outcome|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
44163|NCT02322749|O2|Outcome|Treatment B: Selumetinib Blue Free Base Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
44193|NCT02322216|E2|Reported Event|PATADAY|All subjects treated with olopatadine hydrochloride ophthalmic solution 0.2%
44164|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
44165|NCT02322749|O2|Outcome|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
44166|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
44167|NCT02322749|O2|Outcome|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
44168|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
44169|NCT02322749|O2|Outcome|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
44170|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
44171|NCT02322749|O2|Outcome|Treatment B: Selumetinib Blue Free Base Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
44172|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
44173|NCT02322749|O2|Outcome|Treatment B: Selumetinib Blue Free Base Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
44174|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
44175|NCT02322749|O2|Outcome|Treatment B: Selumetinib Blue Free Base Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
44176|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
44177|NCT02322749|E3|Reported Event|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
44178|NCT02322749|E2|Reported Event|Treatment B: Selumetinib Blue Free Base Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
44179|NCT02322749|E1|Reported Event|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
44180|NCT02322528|B1|Baseline|Administration of Lotemax|An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
44181|NCT02322528|P1|Participant Flow|Administration of 0.5% Lotemax|An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
44182|NCT02322528|O1|Outcome|Administration of 0.5% Lotemax|An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
44183|NCT02322528|O1|Outcome|Administration of 0.5% Lotemax|An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
44184|NCT02322528|E1|Reported Event|Administration of 0.5% Lotemax|An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
44185|NCT02322216|B3|Baseline|Total|Total of all reporting groups
44186|NCT02322216|B2|Baseline|PATANOL|Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days
44187|NCT02322216|B1|Baseline|PATADAY|Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% Vehicle in the evening, 1 drop in each eye for 14 days
44188|NCT02322216|P2|Participant Flow|PATANOL|Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days
44189|NCT02322216|P1|Participant Flow|PATADAY|Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% Vehicle in the evening, 1 drop in each eye for 14 days
44190|NCT02322216|O2|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days
44191|NCT02322216|O1|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% Vehicle in the evening, 1 drop in each eye for 14 days
44192|NCT02322216|E3|Reported Event|PATANOL|All subjects treated with olopatadine hydrochloride ophthalmic solution 0.1%
44194|NCT02322216|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to the initiation of study treatment
44195|NCT02321527|B1|Baseline|CEUS Sentinel Lymph Node Imaging + Guided Biopsy|Subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension before Contrast-Enhanced Ultrasound (CEUS), sentinel lymph node biopsy and radioactive seed placement.
44196|NCT02321527|P1|Participant Flow|CEUS SNL Imaging + Guided Biopsy|Subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension before Contrast-Enhanced Ultrasound (CEUS), sentinel lymph node (SNL) biopsy and radioactive seed placement.
44197|NCT02321527|O1|Outcome|CEUS Sentinel Lymph Node Imaging + Guided Biopsy|Subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension before Contrast-Enhanced Ultrasound (CEUS), sentinel lymph node biopsy and radioactive seed placement.
44198|NCT02321527|E1|Reported Event|CEUS Sentinel Lymph Node Imaging + Guided Biopsy|Subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension before Contrast-Enhanced Ultrasound (CEUS), sentinel lymph node biopsy and radioactive seed placement.
44199|NCT02321436|B3|Baseline|Total Title|
44200|NCT02321436|B2|Baseline|Placebo|Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
44201|NCT02321436|B1|Baseline|Dysport ® 500 U|"Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5 mL.~Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit."
44202|NCT02321436|P2|Participant Flow|Placebo|Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
44203|NCT02321436|P1|Participant Flow|Dysport ® 500 U|"Dysport® 500 U was administered at the clinic in a single intramuscular (IM) injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5 millilitre (mL).~Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit."
44204|NCT02321436|O2|Outcome|Placebo|Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
44205|NCT02321436|O1|Outcome|Dysport ® 500 U|"Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5mL.~Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit."
44206|NCT02321436|O2|Outcome|Placebo|Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
44207|NCT02321436|O1|Outcome|Dysport ® 500 U|"Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5mL.~Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit."
44208|NCT02321436|O2|Outcome|Placebo|Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
44209|NCT02321436|O1|Outcome|Dysport ® 500 U|"Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5mL.~Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit."
44210|NCT02321436|O2|Outcome|Placebo|Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
67813|NCT02153489|O2|Outcome|Placebo|Placebo BID
44211|NCT02321436|O1|Outcome|Dysport ® 500 U|"Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5mL.~Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit."
44212|NCT02321436|O2|Outcome|Placebo|Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
44213|NCT02321436|O1|Outcome|Dysport ® 500 U|"Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5 mL.~Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit."
44214|NCT02321436|O2|Outcome|Placebo|Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
44215|NCT02321436|O1|Outcome|Dysport ® 500 U|"Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5 mL.~Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit."
44216|NCT02321436|E2|Reported Event|Placebo|Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
44217|NCT02321436|E1|Reported Event|Dysport ® 500 U|"Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5mL.~Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit."
44218|NCT02320903|B4|Baseline|Total|Total of all reporting groups
44219|NCT02320903|B3|Baseline|Youth/Teens|"In this study, all enrolled caregivers and teens will be referred to the study by their participating therapists. All caregiver/teen dyads will use the VillageWhere App Prototype that has been developed for this study. They are requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44220|NCT02320903|B2|Baseline|Parents/Caregivers|"In this study, all enrolled caregivers and teens will be referred to the study by their participating therapists. All caregiver/teen dyads will use the VillageWhere App Prototype that has been developed for this study. They are requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44221|NCT02320903|B1|Baseline|Therapists|"In this study, all enrolled caregivers and teens will be referred to the study by their participating therapists. All caregiver/teen dyads will use the VillageWhere App Prototype that has been developed for this study. They are requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44222|NCT02320903|P3|Participant Flow|Youth/Teens|"In this study, all enrolled caregivers and teens will be referred to the study by their participating therapists. All caregiver/teen dyads will use the VillageWhere App Prototype that has been developed for this study. They are requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44223|NCT02320903|P2|Participant Flow|Parents/Caregivers|"In this study, all enrolled caregivers and teens will be referred to the study by their participating therapists. All caregiver/teen dyads will use the VillageWhere App Prototype that has been developed for this study. They are requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44224|NCT02320903|P1|Participant Flow|Therapists|"In this study, all enrolled caregivers and teens will be referred to the study by their participating therapists. All caregiver/teen dyads will use the VillageWhere App Prototype that has been developed for this study. They are requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44225|NCT02320903|O1|Outcome|Youth/Teens Only|Youth/teens who used the app.
44226|NCT02320903|O1|Outcome|Parents/Caregivers Only|Parent/caregiver users of the linked parent-youth phone app system.
44227|NCT02320903|O1|Outcome|Parents/Caregivers Only|Parent/caregiver users of the linked parent-youth phone app system.
44228|NCT02320903|O1|Outcome|Parents/Caregivers Only|Parent/caregiver users of the linked parent-youth phone app system.
44229|NCT02320903|O2|Outcome|Youth/Teens|"All caregiver/teen dyads used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
67814|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
44230|NCT02320903|O1|Outcome|Parents/Caregivers|"All caregiver/teen dyads used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44231|NCT02320903|O2|Outcome|Youth/Teens|"All caregiver/teen dyads used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44232|NCT02320903|O1|Outcome|Parents/Caregivers|"All caregiver/teen dyads used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44233|NCT02320903|O2|Outcome|Youth/Teens|"All caregiver/teen dyads used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44234|NCT02320903|O1|Outcome|Parents/Caregivers|"All caregiver/teen dyads used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44235|NCT02320903|O2|Outcome|Youth/Teens|"All caregiver/teen dyads used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44236|NCT02320903|O1|Outcome|Parents/Caregivers|"All caregiver/teen dyads used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44237|NCT02320903|O2|Outcome|Youth/Teens|"All caregiver/teen dyads used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44238|NCT02320903|O1|Outcome|Parents/Caregivers|"All caregiver/teen dyads used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44239|NCT02320903|O2|Outcome|Youth/Teens|"All caregiver/teen dyads used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44240|NCT02320903|O1|Outcome|Parents/Caregivers|"All caregiver/teen dyads used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44241|NCT02320903|O1|Outcome|Youth/Teens Only|Youth/teens who used the app.
44242|NCT02320903|O1|Outcome|Youth/Teens Only|Youth/teens who used the app.
44243|NCT02320903|O2|Outcome|Youth/Teens|"All caregiver/teen dyads used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44244|NCT02320903|O1|Outcome|Parents/Caregivers|"All caregiver/teen dyads used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44245|NCT02320903|O1|Outcome|Parents/Caregivers Only|Parent/caregiver users of the linked parent-youth phone app system.
44246|NCT02320903|O1|Outcome|Parents/Caregivers|"All caregiver/teen dyads used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44247|NCT02320903|O2|Outcome|Youth/Teens|"All caregiver/teen dyads used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44248|NCT02320903|O1|Outcome|Parents/Caregivers|"All caregiver/teen dyads used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44249|NCT02320903|O1|Outcome|Parents/Caregivers Only|Parent/caregiver users of the linked parent-youth phone app system.
44250|NCT02320903|O2|Outcome|Youth/Teens|"All caregiver/teen dyads used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44251|NCT02320903|O1|Outcome|Parents/Caregivers|"All caregiver/teen dyads used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44252|NCT02320903|O1|Outcome|Parents/Caregivers|"In this single-arm study design, all enrolled caregivers and teens will use the VillageWhere App Prototype that has been developed for this study. They are requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44253|NCT02320903|O1|Outcome|Parents/Caregivers|"All caregiver/teen dyads used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44254|NCT02320903|O1|Outcome|Parents/Caregivers|"All caregivers who used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
44368|NCT02320695|O2|Outcome|Isopropyl Alcohol|70% Isopropyl Alcohol (0.3 cc)
44255|NCT02320903|E1|Reported Event|Use of VillageWhere App Prototype|In this single-arm study design, all enrolled caregivers and teens used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day. Thus, the risk was identical for both parents and teens, since both experienced the app as the only intervention (i.e., there was no comparison group who did not use the app).
44256|NCT02320838|B1|Baseline|All Participants|Participants who were randomized to receive either 5 KHz, TENS or Sham Stimulation
44257|NCT02320838|P5|Participant Flow|5 KHz First, Then Sham and Then TENS|"5KHz: Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.~TENS: Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds.~Sham Stimulation: Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel."
44258|NCT02320838|P4|Participant Flow|TENS First, Then Sham and Then 5KHz|"ENS: Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~5KHz: Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.~Sham Stimulation: Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel."
44259|NCT02320838|P3|Participant Flow|Sham First, Then TENS and Then 5KHz|"Sham stimulation: Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.~TENS: Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~5KHz: Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold."
44260|NCT02320838|P2|Participant Flow|TENS First, Then 5 KHz and Then Sham|"TENS: Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~5KHz: Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.~Sham Stimulation: Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel."
44261|NCT02320838|P1|Participant Flow|5 KHz First, Then TENS and Then Sham|"5KHz: Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.~TENS: Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds.~Sham Stimulation: Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel."
44262|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.~Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44263|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44264|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.~5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44265|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.~Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
67815|NCT02153489|O2|Outcome|Placebo|Placebo BID
44266|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44267|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.~5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44268|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.~Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44269|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44270|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.~5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44271|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.~Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44272|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44273|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.~5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44274|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.~Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44275|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44276|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.~5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44277|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.~Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44278|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44279|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.~5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44280|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.~Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44369|NCT02320695|O1|Outcome|Saline|0.9% Sodium Chloride Saline Solution (0.3 cc)
44281|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44282|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.~5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44283|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.~Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44284|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44285|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.~5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44286|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.~Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44287|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44288|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.~5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44289|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.~Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44290|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44291|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.~5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44292|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.~Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44293|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44294|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.~5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44295|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.~Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44370|NCT02320695|O6|Outcome|Pain Relief Ointment|Neosporin® Plus Pain relief Ointment (0.3 cc)
44296|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44297|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.~5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44298|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.~Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44299|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44300|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.~5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44301|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.~Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44302|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44303|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.~5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44304|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44305|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.~5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44306|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44307|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.~5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44308|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44309|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.~5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44310|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.~Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44311|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44312|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.~5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44313|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.~Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44314|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44315|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.~5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44316|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.~Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44317|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44318|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.~5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44319|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.~Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44320|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44321|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.~5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44322|NCT02320838|E3|Reported Event|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.~Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44323|NCT02320838|E2|Reported Event|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44324|NCT02320838|E1|Reported Event|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.~5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
44325|NCT02320721|B3|Baseline|Total|Total of all reporting groups
44326|NCT02320721|B2|Baseline|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44327|NCT02320721|B1|Baseline|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
67816|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
44328|NCT02320721|P2|Participant Flow|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44329|NCT02320721|P1|Participant Flow|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) subcutaneous (SC) injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44330|NCT02320721|O2|Outcome|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44331|NCT02320721|O1|Outcome|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44332|NCT02320721|O2|Outcome|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44333|NCT02320721|O1|Outcome|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44334|NCT02320721|O2|Outcome|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44335|NCT02320721|O1|Outcome|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44336|NCT02320721|O2|Outcome|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44337|NCT02320721|O1|Outcome|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44338|NCT02320721|O2|Outcome|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44339|NCT02320721|O1|Outcome|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44340|NCT02320721|O2|Outcome|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44341|NCT02320721|O1|Outcome|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44342|NCT02320721|O2|Outcome|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44343|NCT02320721|O1|Outcome|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44344|NCT02320721|O2|Outcome|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44345|NCT02320721|O1|Outcome|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44346|NCT02320721|O2|Outcome|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44347|NCT02320721|O1|Outcome|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44348|NCT02320721|O2|Outcome|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44349|NCT02320721|O1|Outcome|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44350|NCT02320721|O2|Outcome|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44351|NCT02320721|O1|Outcome|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44352|NCT02320721|O2|Outcome|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44353|NCT02320721|O1|Outcome|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44354|NCT02320721|E2|Reported Event|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44355|NCT02320721|E1|Reported Event|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
44356|NCT02320695|B1|Baseline|OVERALL|This includes all 60 randomized subjects. Subjects were assigned to each of the following interventions: Saline, Isopropyl Alcohol, Neosporin Plus Pain Relieving Cream, Neosporin Complete First Aid Antibiotic/Pain Relieving Ointment, Neosporin Original Ointment, Neosporin Plus Pain Relief Ointment. The sequence in which participants received the intervention was randomized.
44357|NCT02320695|P1|Participant Flow|OVERALL|Subjects were assigned to each of the following interventions: Saline, Isopropyl Alcohol, Neosporin Plus Pain Relieving Cream, Neosporin Complete First Aid Antibiotic/Pain Relieving Ointment, Neosporin Original Ointment, Neosporin Plus Pain Relief Ointment. The sequence in which participants received the intervention was randomized.
44358|NCT02320695|O6|Outcome|Pain Relief Ointment|Neosporin® Plus Pain relief Ointment (0.3 cc)
44359|NCT02320695|O5|Outcome|Original Ointment|Neosporin® Original Ointment (0.3 cc)
44360|NCT02320695|O4|Outcome|Antibiotic/Pain Relieving Ointment|Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
44361|NCT02320695|O3|Outcome|Pain Relieving Cream|Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
44362|NCT02320695|O2|Outcome|Isopropyl Alcohol|70% Isopropyl Alcohol (0.3 cc)
44363|NCT02320695|O1|Outcome|Saline|0.9% Sodium Chloride Saline Solution (0.3 cc)
44364|NCT02320695|O6|Outcome|Pain Relief Ointment|Neosporin® Plus Pain relief Ointment (0.3 cc)
44365|NCT02320695|O5|Outcome|Original Ointment|Neosporin® Original Ointment (0.3 cc)
44366|NCT02320695|O4|Outcome|Antibiotic/Pain Relieving Ointment|Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
44367|NCT02320695|O3|Outcome|Pain Relieving Cream|Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
44372|NCT02320695|O4|Outcome|Antibiotic/Pain Relieving Ointment|Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
44373|NCT02320695|O3|Outcome|Pain Relieving Cream|Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
44374|NCT02320695|O2|Outcome|Isopropyl Alcohol|70% Isopropyl Alcohol (0.3 cc)
44375|NCT02320695|O1|Outcome|Saline|0.9% Sodium Chloride Saline Solution (0.3 cc)
44376|NCT02320695|O6|Outcome|Pain Relief Ointment|Neosporin® Plus Pain relief Ointment (0.3 cc)
44377|NCT02320695|O5|Outcome|Original Ointment|Neosporin® Original Ointment (0.3 cc)
44378|NCT02320695|O4|Outcome|Antibiotic/Pain Relieving Ointment|Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
44379|NCT02320695|O3|Outcome|Pain Relieving Cream|Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
44380|NCT02320695|O2|Outcome|Isopropyl Alcohol|70% Isopropyl Alcohol (0.3 cc)
44381|NCT02320695|O1|Outcome|Saline|0.9% Sodium Chloride Saline Solution (0.3 cc)
44382|NCT02320695|E1|Reported Event|OVERALL|This includes all 60 randomized subjects.
44383|NCT02320487|B1|Baseline|Obinutuzumab + Bendamustine (BG)|Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
44384|NCT02320487|P1|Participant Flow|Obinutuzumab + Bendamustine (BG)|Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
44385|NCT02320487|O1|Outcome|Obinutuzumab + Bendamustine (BG)|Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
44386|NCT02320487|O1|Outcome|Obinutuzumab + Bendamustine (BG)|Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
44387|NCT02320487|O1|Outcome|Obinutuzumab + Bendamustine (BG)|Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
44388|NCT02320487|O1|Outcome|Obinutuzumab + Bendamustine (BG)|Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
44389|NCT02320487|O1|Outcome|Obinutuzumab + Bendamustine (BG)|Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
44390|NCT02320487|O1|Outcome|Obinutuzumab + Bendamustine (BG)|Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
44391|NCT02320487|O1|Outcome|Obinutuzumab + Bendamustine (BG)|Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
44392|NCT02320487|O1|Outcome|Obinutuzumab + Bendamustine (BG)|Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
44393|NCT02320487|O1|Outcome|Obinutuzumab + Bendamustine (BG)|Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
44394|NCT02320487|O1|Outcome|Obinutuzumab + Bendamustine (BG)|Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
44395|NCT02320487|O1|Outcome|Obinutuzumab + Bendamustine (BG)|Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
44396|NCT02320487|O1|Outcome|Obinutuzumab + Bendamustine (BG)|Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
44397|NCT02320487|O1|Outcome|Obinutuzumab + Bendamustine (BG)|Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
44398|NCT02320487|O1|Outcome|Obinutuzumab + Bendamustine (BG)|Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
44399|NCT02320487|O1|Outcome|Obinutuzumab + Bendamustine (BG)|Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
44400|NCT02320487|E1|Reported Event|Obinutuzumab + Bendamustine (BG)|Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
44401|NCT02320396|B3|Baseline|Total|Total of all reporting groups
44402|NCT02320396|B2|Baseline|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44403|NCT02320396|B1|Baseline|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44404|NCT02320396|P2|Participant Flow|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44405|NCT02320396|P1|Participant Flow|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44406|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44407|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44408|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44409|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44410|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44512|NCT02319525|O1|Outcome|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
44411|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44412|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44413|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44414|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44415|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44416|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44417|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44418|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44419|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44420|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44421|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44422|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44423|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44424|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44425|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44426|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44427|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44428|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44429|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44430|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44431|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44432|NCT02320396|E2|Reported Event|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44433|NCT02320396|E1|Reported Event|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
44434|NCT02320227|B1|Baseline|Experimental: Healthy Subjects|Novel Personal Lubricant Miami w/o Fragrance
44435|NCT02320227|P1|Participant Flow|Experimental: Healthy Subjects|Novel Personal Lubricant Miami w/o Fragrance
44436|NCT02320227|O1|Outcome|Miami w/o Frag Personal Lubricant|Healthy subjects use Miami w/o frag Personal lubricant at least 4 times per week for 2 weeks.
44437|NCT02320227|O1|Outcome|Miami w/o Frag Personal Lubricant|Healthy subjects use Miami w/o frag Personal lubricant at least 4 times per week for 2 weeks
44438|NCT02320227|E1|Reported Event|Experimental: Healthy Subjects|Novel Personal Lubricant Miami w/o Fragrance
44439|NCT02320214|B1|Baseline|Novel Lubricant Miami w/ Frag Personal Lubricant|Healthy subjects use Novel lubricant Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks.
44440|NCT02320214|P1|Participant Flow|Novel Lubricant Miami w/ Frag Personal Lubricant|Healthy subjects use Novel lubricant Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks.
44441|NCT02320214|O1|Outcome|Miami w/ Frag Personal Lubricant|Healthy subjects use Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks.
44442|NCT02320214|O1|Outcome|Miami w/ Frag Personal Lubricant|Healthy subjects use Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks.
44443|NCT02320214|E1|Reported Event|Miami w/ Frag Personal Lubricant|Healthy subjects use Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks.
44444|NCT02320149|B3|Baseline|Total|Total of all reporting groups
44445|NCT02320149|B2|Baseline|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44446|NCT02320149|B1|Baseline|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44447|NCT02320149|P2|Participant Flow|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44448|NCT02320149|P1|Participant Flow|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44449|NCT02320149|O2|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44450|NCT02320149|O1|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44451|NCT02320149|O2|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44452|NCT02320149|O1|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44453|NCT02320149|O2|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44454|NCT02320149|O1|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44455|NCT02320149|O2|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44456|NCT02320149|O1|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44457|NCT02320149|O2|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44458|NCT02320149|O1|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44459|NCT02320149|O2|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44460|NCT02320149|O1|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44461|NCT02320149|O2|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44462|NCT02320149|O1|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44463|NCT02320149|O2|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44464|NCT02320149|O1|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44465|NCT02320149|O2|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44466|NCT02320149|O1|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44467|NCT02320149|O2|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44468|NCT02320149|O1|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44469|NCT02320149|O2|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44470|NCT02320149|O1|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44471|NCT02320149|O2|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44472|NCT02320149|O1|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44473|NCT02320149|O2|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44474|NCT02320149|O1|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44475|NCT02320149|O2|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44476|NCT02320149|O1|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44477|NCT02320149|O2|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44478|NCT02320149|O1|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44479|NCT02320149|O2|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44480|NCT02320149|O1|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44481|NCT02320149|O2|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44482|NCT02320149|O1|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44483|NCT02320149|E2|Reported Event|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
44484|NCT02320149|E1|Reported Event|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
44485|NCT02319824|B1|Baseline|Treatment (Radiation and NY-ESO-1-specific T Cells)|"Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells 2-3 days after completion of radiation therapy.~Autologous NY-ESO-1-specific CD8-positive T Lymphocytes"
44486|NCT02319824|P1|Participant Flow|Treatment (Radiation and NY-ESO-1-specific T Cells)|Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells IV 2-3 days after completion of radiation therapy.
44487|NCT02319824|O1|Outcome|Treatment (Radiation and NY-ESO-1-specific T Cells)|Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells 2-3 days after completion of radiation therapy.
44513|NCT02319525|O2|Outcome|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
67817|NCT02153489|O2|Outcome|Placebo|Placebo BID
44488|NCT02319824|O1|Outcome|Treatment (Radiation and NY-ESO-1-specific T Cells)|Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells 2-3 days after completion of radiation therapy.
44489|NCT02319824|O1|Outcome|Treatment (Radiation and NY-ESO-1-specific T Cells)|Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells I60 minutes 2-3 days after completion of radiation therapy.
44490|NCT02319824|E1|Reported Event|Treatment (Radiation and NY-ESO-1-specific T Cells)|Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells 2-3 days after completion of radiation therapy.
44491|NCT02319668|B3|Baseline|Total|Total of all reporting groups
44492|NCT02319668|B2|Baseline|Reference Product|Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing.
44493|NCT02319668|B1|Baseline|Test and Reference Product|Participants rinsed for one timed minute with 10 mL of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brush prior to using mouthwash).
44494|NCT02319668|P2|Participant Flow|Reference Product|Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing.
44495|NCT02319668|P1|Participant Flow|Test and Reference Product|Participants rinsed for one timed minute with 10 milliliter (mL) of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brush prior to using mouthwash).
44496|NCT02319668|O2|Outcome|Reference Product|Participants did not receive any product (mouthwash containing Chlorhexidine digluconate or toothpaste containing sodium fluoride) during analysis of this outcome as this analysis was performed at baseline.
44497|NCT02319668|O1|Outcome|Test and Reference Product|Participants rinsed for one timed minute with 10 mL of Test product only (mouthwash containing Chlorhexidine digluconate). Participants did not receive reference product(toothpaste containing sodium fluoride) during analysis of this outcome as this analysis was performed at baseline.
44498|NCT02319668|O2|Outcome|Reference Product|Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing.
44499|NCT02319668|O1|Outcome|Test and Reference Product|Participants rinsed for one timed minute with 10 mL of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brush prior to using mouthwash).
44500|NCT02319668|O2|Outcome|Reference Product|Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing.
44501|NCT02319668|O1|Outcome|Test and Reference Products|Participants rinsed for one timed minute with 10 mL of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brush prior to using mouthwash).
44502|NCT02319668|O2|Outcome|Reference Product|Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing.
44503|NCT02319668|O1|Outcome|Test and Reference Product|Participants rinsed for one timed minute with 10 mL of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brush prior to using mouthwash).
44504|NCT02319668|E2|Reported Event|Reference Product|Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing.
44505|NCT02319668|E1|Reported Event|Test and Reference Product|Participants rinsed for one timed minute with 10 mL of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brushed prior to using mouthwash).
44506|NCT02319525|B3|Baseline|Total|Total of all reporting groups
44507|NCT02319525|B2|Baseline|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
44508|NCT02319525|B1|Baseline|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
44509|NCT02319525|P2|Participant Flow|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
44510|NCT02319525|P1|Participant Flow|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
44511|NCT02319525|O2|Outcome|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
44514|NCT02319525|O1|Outcome|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
44515|NCT02319525|O2|Outcome|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
44516|NCT02319525|O1|Outcome|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
44517|NCT02319525|O2|Outcome|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
44518|NCT02319525|O1|Outcome|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
44519|NCT02319525|O2|Outcome|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
44520|NCT02319525|O1|Outcome|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
44521|NCT02319525|O2|Outcome|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
44522|NCT02319525|O1|Outcome|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
44523|NCT02319525|O2|Outcome|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
44524|NCT02319525|O1|Outcome|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
44525|NCT02319525|E2|Reported Event|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
44526|NCT02319525|E1|Reported Event|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
44527|NCT02319486|B1|Baseline|CEV With/Without Carboplatin|"CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection~carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection~CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2"
44528|NCT02319486|P1|Participant Flow|CEV With/Without Carboplatin|"CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection~carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection~CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2"
44529|NCT02319486|O2|Outcome|CEV With/Without Carboplatin - Stage 3|CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2
44530|NCT02319486|O1|Outcome|CEV With/Without Carboplatin- Stage 2|"CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection~carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection~CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2"
44531|NCT02319486|E2|Reported Event|CEV With/Without Carboplatin-Stage 3|"CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection~carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection~CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2"
44532|NCT02319486|E1|Reported Event|CEV With/Without Carboplatin-Stage 2|"CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection~carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection~CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2"
44533|NCT02319317|B3|Baseline|Total|Total of all reporting groups
44534|NCT02319317|B2|Baseline|Control Group|"Web-based behavioral intervention for healthy lifestyles.~Control group general health promotion: The control group will receive a web-based intervention for general health promotion and is designed to enhance participants’ knowledge and ability to reduce their risk of adverse health conditions including, obesity and heart disease."
44535|NCT02319317|B1|Baseline|Risky Driving Prevention|"Web-based behavioral intervention to promote teen driver attention to the roadway, addressing mobile technology and passengers.~Risky driving prevention: The web-based intervention to prevent risky driving targets knowledge, attitudes, perceived control and norms about driver inattention, with strategies to keep attention on the roadway."
44536|NCT02319317|P2|Participant Flow|Control Group|"Web-based behavioral intervention for healthy lifestyles.~Control group general health promotion: The control group will receive a web-based intervention for general health promotion and is designed to enhance participants’ knowledge and ability to reduce their risk of adverse health conditions including, obesity and heart disease."
44537|NCT02319317|P1|Participant Flow|Risky Driving Prevention|"Web-based behavioral intervention to promote teen driver attention to the roadway, addressing mobile technology and passengers.~Risky driving prevention: The web-based intervention to prevent risky driving targets knowledge, attitudes, perceived control and norms about driver inattention, with strategies to keep attention on the roadway."
44538|NCT02319317|O2|Outcome|Control Group|"Web-based behavioral intervention for healthy lifestyles.~Control group general health promotion: The control group will receive a web-based intervention for general health promotion and is designed to enhance participants’ knowledge and ability to reduce their risk of adverse health conditions including, obesity and heart disease."
44539|NCT02319317|O1|Outcome|Risky Driving Prevention|"Web-based behavioral intervention to promote teen driver attention to the roadway, addressing mobile technology and passengers.~Risky driving prevention: The web-based intervention to prevent risky driving targets knowledge, attitudes, perceived control and norms about driver inattention, with strategies to keep attention on the roadway."
44540|NCT02319317|E2|Reported Event|Control Group|"Web-based behavioral intervention for healthy lifestyles.~Control group general health promotion: The control group will receive a web-based intervention for general health promotion and is designed to enhance participants’ knowledge and ability to reduce their risk of adverse health conditions including, obesity and heart disease."
44541|NCT02319317|E1|Reported Event|Risky Driving Prevention|"Web-based behavioral intervention to promote teen driver attention to the roadway, addressing mobile technology and passengers.~Risky driving prevention: The web-based intervention to prevent risky driving targets knowledge, attitudes, perceived control and norms about driver inattention, with strategies to keep attention on the roadway."
44542|NCT02319148|B4|Baseline|Total|Total of all reporting groups
44543|NCT02319148|B3|Baseline|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
44544|NCT02319148|B2|Baseline|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
44545|NCT02319148|B1|Baseline|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
44546|NCT02319148|P4|Participant Flow|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
44547|NCT02319148|P3|Participant Flow|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
44548|NCT02319148|P2|Participant Flow|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
44549|NCT02319148|P1|Participant Flow|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
44550|NCT02319148|O7|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
44551|NCT02319148|O6|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
44552|NCT02319148|O5|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
44553|NCT02319148|O4|Outcome|Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days.
44554|NCT02319148|O3|Outcome|Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days.
44555|NCT02319148|O2|Outcome|Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days.
44556|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
44557|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
44558|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
44559|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
44560|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
44561|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
44562|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
44563|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
44564|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
44565|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
44566|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
44567|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
44568|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
44569|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
44570|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
44571|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
44572|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
44573|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
44574|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
44575|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
67818|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
44576|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
44577|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
44578|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
44579|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
44580|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
44581|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
44582|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
44583|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
44584|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
44585|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
44586|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
44587|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
44588|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
44589|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
44590|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
44591|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
44592|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
44593|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
44594|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
44595|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
44596|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
44597|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
44598|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
44599|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
44600|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
44601|NCT02319148|E7|Reported Event|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
44602|NCT02319148|E6|Reported Event|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
44603|NCT02319148|E5|Reported Event|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
44604|NCT02319148|E4|Reported Event|Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days.
44605|NCT02319148|E3|Reported Event|Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days.
44606|NCT02319148|E2|Reported Event|Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days.
44607|NCT02319148|E1|Reported Event|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
44608|NCT02319031|B3|Baseline|Total|Total of all reporting groups
44609|NCT02319031|B2|Baseline|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
67819|NCT02153489|O2|Outcome|Placebo|Placebo BID
44610|NCT02319031|B1|Baseline|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
44611|NCT02319031|P2|Participant Flow|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
44612|NCT02319031|P1|Participant Flow|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
44613|NCT02319031|O2|Outcome|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
44614|NCT02319031|O1|Outcome|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
44615|NCT02319031|O2|Outcome|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
44616|NCT02319031|O1|Outcome|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
44617|NCT02319031|O2|Outcome|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
44618|NCT02319031|O1|Outcome|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
44619|NCT02319031|E2|Reported Event|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
44698|NCT02318303|B4|Baseline|Olopatadine HCl-1 NS (QD)|Olopatadine HCl-1 NS administered as 2 sprays/nostril
44620|NCT02319031|E1|Reported Event|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
44621|NCT02318940|B3|Baseline|Total|Total of all reporting groups
44622|NCT02318940|B2|Baseline|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only~central venous catheter: installation of Central venous catheter ultrasound guided"
44623|NCT02318940|B1|Baseline|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.~access will be through the femoral vein only~central venous catheter: installation of Central venous catheter landmark guided"
44624|NCT02318940|P2|Participant Flow|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only~central venous catheter: installation of Central venous catheter ultrasound guided"
44625|NCT02318940|P1|Participant Flow|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.~access will be through the femoral vein only~central venous catheter: installation of Central venous catheter landmark guided"
44626|NCT02318940|O2|Outcome|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only~central venous catheter: installation of Central venous catheter ultrasound guided"
44627|NCT02318940|O1|Outcome|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.~access will be through the femoral vein only~central venous catheter: installation of Central venous catheter landmark guided"
44628|NCT02318940|O2|Outcome|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only~central venous catheter: installation of Central venous catheter ultrasound guided"
44629|NCT02318940|O1|Outcome|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.~access will be through the femoral vein only~central venous catheter: installation of Central venous catheter landmark guided"
44630|NCT02318940|O2|Outcome|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only~central venous catheter: installation of Central venous catheter ultrasound guided"
44631|NCT02318940|O1|Outcome|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.~access will be through the femoral vein only~central venous catheter: installation of Central venous catheter landmark guided"
44632|NCT02318940|O2|Outcome|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only~central venous catheter: installation of Central venous catheter ultrasound guided"
44633|NCT02318940|O1|Outcome|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.~access will be through the femoral vein only~central venous catheter: installation of Central venous catheter landmark guided"
44634|NCT02318940|E2|Reported Event|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only~central venous catheter: installation of Central venous catheter ultrasound guided"
44635|NCT02318940|E1|Reported Event|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.~access will be through the femoral vein only~central venous catheter: installation of Central venous catheter landmark guided"
44636|NCT02318797|B3|Baseline|Total|Total of all reporting groups
44637|NCT02318797|B2|Baseline|Provider-Supported Integrated Care|"See intervention description~Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education"
44638|NCT02318797|B1|Baseline|Patient Self-Directed Care|"See intervention description~Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs"
44639|NCT02318797|P2|Participant Flow|Provider-Supported Integrated Care|"See intervention description~Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education"
44640|NCT02318797|P1|Participant Flow|Patient Self-Directed Care|"See intervention description~Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs"
44641|NCT02318797|O2|Outcome|Provider-Supported Integrated Care|"See intervention description~Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education"
44642|NCT02318797|O1|Outcome|Patient Self-Directed Care|"See intervention description~Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs"
44699|NCT02318303|B3|Baseline|Mometasone Furoate-1 NS (QD)|Mometasone furoate-1 NS administered as 2 sprays/nostril
44700|NCT02318303|B2|Baseline|GSP 301-1 NS (QD)|GSP 301-1 NS administered as 2 sprays/nostril
44643|NCT02318797|O2|Outcome|Provider-Supported Integrated Care|"See intervention description~Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education"
44644|NCT02318797|O1|Outcome|Patient Self-Directed Care|"See intervention description~Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs"
44645|NCT02318797|O2|Outcome|Provider-Supported Integrated Care|"See intervention description~Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education"
44646|NCT02318797|O1|Outcome|Patient Self-Directed Care|"See intervention description~Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs"
44647|NCT02318797|O2|Outcome|Provider-Supported Integrated Care|"See intervention description~Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education"
44648|NCT02318797|O1|Outcome|Patient Self-Directed Care|"See intervention description~Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs"
44649|NCT02318797|O2|Outcome|Provider-Supported Integrated Care|"See intervention description~Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education"
44650|NCT02318797|O1|Outcome|Patient Self-Directed Care|"See intervention description~Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs"
44651|NCT02318797|O2|Outcome|Provider-Supported Integrated Care|"See intervention description~Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education"
44652|NCT02318797|O1|Outcome|Patient Self-Directed Care|"See intervention description~Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs"
44653|NCT02318797|O2|Outcome|Provider-Supported Integrated Care|"See intervention description~Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education"
44654|NCT02318797|O1|Outcome|Patient Self-Directed Care|"See intervention description~Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs"
44655|NCT02318797|O2|Outcome|Provider-Supported Integrated Care|"See intervention description~Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education"
44656|NCT02318797|O1|Outcome|Patient Self-Directed Care|"See intervention description~Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs"
44657|NCT02318797|O2|Outcome|Provider-Supported Integrated Care|"See intervention description~Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education"
44658|NCT02318797|O1|Outcome|Patient Self-Directed Care|"See intervention description~Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs"
44659|NCT02318797|O2|Outcome|Provider-Supported Integrated Care|"See intervention description~Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education"
44660|NCT02318797|O1|Outcome|Patient Self-Directed Care|"See intervention description~Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs"
44661|NCT02318797|O2|Outcome|Provider-Supported Integrated Care|"See intervention description~Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education"
44662|NCT02318797|O1|Outcome|Patient Self-Directed Care|"See intervention description~Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs"
44663|NCT02318797|O2|Outcome|Provider-Supported Integrated Care|"See intervention description~Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education"
44701|NCT02318303|B1|Baseline|GSP 301 Placebo NS|GSP 301 placebo NS administered as 2 sprays/nostril
44664|NCT02318797|O1|Outcome|Patient Self-Directed Care|"See intervention description~Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs"
44665|NCT02318797|O2|Outcome|Provider-Supported Integrated Care|"See intervention description~Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education"
44666|NCT02318797|O1|Outcome|Patient Self-Directed Care|"See intervention description~Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs"
44667|NCT02318797|O2|Outcome|Provider-Supported Integrated Care|"See intervention description~Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education"
44668|NCT02318797|O1|Outcome|Patient Self-Directed Care|"See intervention description~Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs"
44669|NCT02318797|O2|Outcome|Provider-Supported Integrated Care|"See intervention description~Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education"
44670|NCT02318797|O1|Outcome|Patient Self-Directed Care|"See intervention description~Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs"
44671|NCT02318797|O2|Outcome|Provider-Supported Integrated Care|"See intervention description~Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education"
44672|NCT02318797|O1|Outcome|Patient Self-Directed Care|"See intervention description~Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs"
44673|NCT02318797|O2|Outcome|Provider-Supported Integrated Care|"See intervention description~Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education"
44674|NCT02318797|O1|Outcome|Patient Self-Directed Care|"See intervention description~Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs"
44675|NCT02318797|E2|Reported Event|Provider-Supported Integrated Care|"See intervention description~Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education"
44676|NCT02318797|E1|Reported Event|Patient Self-Directed Care|"See intervention description~Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs"
44677|NCT02318693|B3|Baseline|Total|Total of all reporting groups
44678|NCT02318693|B2|Baseline|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
44679|NCT02318693|B1|Baseline|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
44680|NCT02318693|P2|Participant Flow|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days. TDD = Total daily dose.
44681|NCT02318693|P1|Participant Flow|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
44682|NCT02318693|O2|Outcome|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
44683|NCT02318693|O1|Outcome|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
44684|NCT02318693|O2|Outcome|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
44685|NCT02318693|O1|Outcome|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
44686|NCT02318693|O2|Outcome|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
44687|NCT02318693|O1|Outcome|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
44688|NCT02318693|O2|Outcome|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
44689|NCT02318693|O1|Outcome|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
44690|NCT02318693|O2|Outcome|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
44691|NCT02318693|O1|Outcome|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
44692|NCT02318693|E2|Reported Event|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
44693|NCT02318693|E1|Reported Event|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
44694|NCT02318303|B8|Baseline|Total|Total of all reporting groups
44695|NCT02318303|B7|Baseline|Olopatadine HCl-2 NS (BID)|Olopatadine HCl-2 NS administered as 2 sprays/nostril
44696|NCT02318303|B6|Baseline|Mometasone Furoate-2 NS (BID)|Mometasone furoate-2 NS administered as 2 sprays/nostril
44697|NCT02318303|B5|Baseline|GSP 301-2 NS (BID)|GSP 301-2 NS administered as 2 sprays/nostril
67820|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
44702|NCT02318303|P7|Participant Flow|Olopatadine HCl-2 NS (BID)|Olopatadine HCl-2 NS (665 μg) administered as 2 sprays/nostril
44703|NCT02318303|P6|Participant Flow|Mometasone Furoate-2 NS (BID)|Mometasone furoate-2 NS (25 μg) administered as 2 sprays/nostril
44704|NCT02318303|P5|Participant Flow|GSP 301-2 NS (BID)|GSP 301-2 NS (665 μg olopatadine hydrochloride/25 μg mometasone furoate) administered as 2 sprays/nostril
44705|NCT02318303|P4|Participant Flow|Olopatadine HCl-1 NS (QD)|Olopatadine HCl-1 NS (665 μg) administered as 2 sprays/nostril
44706|NCT02318303|P3|Participant Flow|Mometasone Furoate-1 NS (QD)|Mometasone furoate-1 NS (50 μg) administered as 2 sprays/nostril
44707|NCT02318303|P2|Participant Flow|GSP 301-1 NS (QD)|GSP 301-1 NS (665 μg olopatadine hydrochloride/50 μg mometasone furoate) administered as 2 sprays/nostril
44708|NCT02318303|P1|Participant Flow|GSP 301 Placebo NS|GSP 301 placebo NS administered as 2 sprays/nostril
44709|NCT02318303|O7|Outcome|Olopatadine HCl-2 NS (BID)|Olopatadine HCl-2 NS (BID) administered as 2 sprays/nostril
44710|NCT02318303|O6|Outcome|Mometasone Furoate-2 NS (BID)|Mometasone furoate-2 NS (BID) administered as 2 sprays/nostril
44711|NCT02318303|O5|Outcome|GSP 301-2 NS (BID)|GSP 301-2 NS (BID) administered as 2 sprays/nostril
44712|NCT02318303|O4|Outcome|Olopatadine HCl-1 NS (QD)|Olopatadine HCl-1 NS (QD) administered as 2 sprays/nostril
44713|NCT02318303|O3|Outcome|Mometasone Furoate-1 NS (QD)|Mometasone furoate-1 NS (QD) administered as 2 sprays/nostril
44714|NCT02318303|O2|Outcome|GSP 301-1 NS (QD)|GSP 301-1 NS (QD) administered as 2 sprays/nostril
44715|NCT02318303|O1|Outcome|GSP 301 Placebo|GSP 301 placebo NS administered as 2 sprays/nostril
44716|NCT02318303|E7|Reported Event|Olopatadine HCl-2 NS (BID)|Olopatadine HCl-2 NS (BID) administered as 2 sprays/nostril
44717|NCT02318303|E6|Reported Event|Mometasone Furoate-2 NS (BID)|Mometasone furoate-2 NS (BID) administered as 2 sprays/nostril
44718|NCT02318303|E5|Reported Event|GSP 301-2 NS (BID)|GSP 301-2 NS (BID) administered as 2 sprays/nostril.
44719|NCT02318303|E4|Reported Event|Olopatadine HCl-1 NS (QD)|Olopatadine HCl-1 NS (QD) administered as 2 sprays/nostril
44720|NCT02318303|E3|Reported Event|Mometasone Furoate-1 NS (QD)|Mometasone furoate-1 NS (QD) administered as 2 sprays/nostril
44721|NCT02318303|E2|Reported Event|GSP 301-1 NS (QD)|GSP 301-1 NS (QD) administered as 2 sprays/nostril
44722|NCT02318303|E1|Reported Event|GSP 301 Placebo NS|GSP 301 placebo NS administered as 2 sprays/nostril
44723|NCT02317809|B1|Baseline|All Subjects|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector or 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first or second intervention period.
44724|NCT02317809|P2|Participant Flow|First Freeze-dried Pergoveris, Then Liquid Pergoveris|Subjects were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in the first intervention period followed by 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in the second intervention period. Both the periods were separated by a washout period of 14 to 17 days.
44725|NCT02317809|P1|Participant Flow|First Liquid Pergoveris, Then Freeze-dried Pergoveris|Subjects were administered with 900 international units (IU) of recombinant human follicle-stimulating hormone (r-hFSH) and 450 IU of recombinant human luteinizing hormone (r-hLH) solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in the first intervention period followed by 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in the second intervention period. Both the periods were separated by a washout period of 14 to 17 days.
44726|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
44727|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
44728|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
44729|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
44730|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
44731|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
44732|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
44733|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
44734|NCT02317809|O2|Outcome|First Freeze-dried Pergoveris, Then Liquid Pergoveris|Subjects were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in the first intervention period followed by 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in the second intervention period. Both the periods were separated by a washout period of 14 to 17 days.
44801|NCT02317692|E1|Reported Event|Standard ADHD Parent Training|"8 sessions of evidence-based parent training plus school intervention~Parent training"
44802|NCT02317549|B3|Baseline|Total|Total of all reporting groups
44735|NCT02317809|O1|Outcome|First Liquid Pergoveris, Then Freeze-dried Pergoveris|Subjects were administered with 900 international units (IU) of recombinant human follicle-stimulating hormone (r-hFSH) and 450 IU of recombinant human luteinizing hormone (r-hLH) solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in the first intervention period followed by 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in the second intervention period. Both the periods were separated by a washout period of 14 to 17 days.
44736|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
44737|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
44738|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
44739|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
44740|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
44741|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
44742|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
44743|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
44744|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
44745|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
44746|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
44747|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
44748|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
44749|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
44750|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
44751|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
44752|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
44753|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
44754|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
44755|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
44756|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
44757|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
44758|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
44803|NCT02317549|B2|Baseline|Placebo|"Daily a total of 700 mL of Placebo solution will be administered orally or via NG/OG/NJ/ND/PEG tube~Placebo"
44759|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
44760|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
44761|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
44762|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
44763|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
44764|NCT02317809|E2|Reported Event|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
44765|NCT02317809|E1|Reported Event|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
44766|NCT02317744|B3|Baseline|Total|Total of all reporting groups
44767|NCT02317744|B2|Baseline|Pill Placebo|"Daily placebo medication for 3 months~Pill Placebo"
44768|NCT02317744|B1|Baseline|Naltrexone/ Bupropion Combination|"50 mg naltrexone and 300 mg bupropion per day for 3 months~Naltrexone and bupropion combination"
44769|NCT02317744|P2|Participant Flow|Pill Placebo|"Daily placebo medication for 3 months~Pill Placebo"
44770|NCT02317744|P1|Participant Flow|Naltrexone/ Bupropion Combination|"50 mg naltrexone and 300 mg bupropion per day for 3 months~Naltrexone and bupropion combination"
44771|NCT02317744|O2|Outcome|Pill Placebo|"Daily placebo medication for 3 months~Pill Placebo"
44772|NCT02317744|O1|Outcome|Naltrexone/ Bupropion Combination|"50 mg naltrexone and 300 mg bupropion per day for 3 months~Naltrexone and bupropion combination"
44773|NCT02317744|O2|Outcome|Pill Placebo|"Daily placebo medication for 3 months~Pill Placebo"
44774|NCT02317744|O1|Outcome|Naltrexone/ Bupropion Combination|"50 mg naltrexone and 300 mg bupropion per day for 3 months~Naltrexone and bupropion combination"
44775|NCT02317744|O2|Outcome|Pill Placebo|"Daily placebo medication for 3 months~Pill Placebo"
44776|NCT02317744|O1|Outcome|Naltrexone/ Bupropion Combination|"50 mg naltrexone and 300 mg bupropion per day for 3 months~Naltrexone and bupropion combination"
44777|NCT02317744|O2|Outcome|Pill Placebo|"Daily placebo medication for 3 months~Pill Placebo"
44778|NCT02317744|O1|Outcome|Naltrexone/ Bupropion Combination|"50 mg naltrexone and 300 mg bupropion per day for 3 months~Naltrexone and bupropion combination"
44779|NCT02317744|E2|Reported Event|Pill Placebo|"Daily placebo medication for 3 months~Pill Placebo"
44780|NCT02317744|E1|Reported Event|Naltrexone/ Bupropion Combination|"50 mg naltrexone and 300 mg bupropion per day for 3 months~Naltrexone and bupropion combination"
44781|NCT02317692|B3|Baseline|Total|Total of all reporting groups
44782|NCT02317692|B2|Baseline|Culturally-modified ADHD Parent Training|"8 sessions of culturally-modified parent training plus school intervention~Parent training"
44783|NCT02317692|B1|Baseline|Standard ADHD Parent Training|"8 sessions of evidence-based parent training plus school intervention~Parent training"
44784|NCT02317692|P2|Participant Flow|Culturally-modified ADHD Parent Training|"8 sessions of culturally-modified parent training plus school intervention~Parent training"
44785|NCT02317692|P1|Participant Flow|Standard ADHD Parent Training|"8 sessions of evidence-based parent training plus school intervention~Parent training"
44786|NCT02317692|O2|Outcome|Culturally-modified ADHD Parent Training|"8 sessions of culturally-modified parent training plus school intervention~Parent training"
44787|NCT02317692|O1|Outcome|Standard ADHD Parent Training|"8 sessions of evidence-based parent training plus school intervention~Parent training"
44788|NCT02317692|O2|Outcome|Culturally-modified ADHD Parent Training|"8 sessions of culturally-modified parent training plus school intervention~Parent training"
44789|NCT02317692|O1|Outcome|Standard ADHD Parent Training|"8 sessions of evidence-based parent training plus school intervention~Parent training"
44790|NCT02317692|O2|Outcome|Culturally-modified ADHD Parent Training|"8 sessions of culturally-modified parent training plus school intervention~Parent training"
44791|NCT02317692|O1|Outcome|Standard ADHD Parent Training|"8 sessions of evidence-based parent training plus school intervention~Parent training"
44792|NCT02317692|O2|Outcome|Culturally-modified ADHD Parent Training|"8 sessions of culturally-modified parent training plus school intervention~Parent training"
44793|NCT02317692|O1|Outcome|Standard ADHD Parent Training|"8 sessions of evidence-based parent training plus school intervention~Parent training"
44794|NCT02317692|O2|Outcome|Culturally-modified ADHD Parent Training|"8 sessions of culturally-modified parent training plus school intervention~Parent training"
44795|NCT02317692|O1|Outcome|Standard ADHD Parent Training|"8 sessions of evidence-based parent training plus school intervention~Parent training"
44796|NCT02317692|O2|Outcome|Culturally-modified ADHD Parent Training|"8 sessions of culturally-modified parent training plus school intervention~Parent training"
44797|NCT02317692|O1|Outcome|Standard ADHD Parent Training|"8 sessions of evidence-based parent training plus school intervention~Parent training"
44798|NCT02317692|O2|Outcome|Culturally-modified ADHD Parent Training|"8 sessions of culturally-modified parent training plus school intervention~Parent training"
44799|NCT02317692|O1|Outcome|Standard ADHD Parent Training|"8 sessions of evidence-based parent training plus school intervention~Parent training"
44800|NCT02317692|E2|Reported Event|Culturally-modified ADHD Parent Training|"8 sessions of culturally-modified parent training plus school intervention~Parent training"
44804|NCT02317549|B1|Baseline|Tranexemic Acid|"Daily a total of 700 mL of LB1148 solution containing 7.5 g of tranexemic acid will be administered orally or via NG/OG/NJ/ND/PEG tube~LB1148"
44805|NCT02317549|P2|Participant Flow|Placebo|"Daily a total of 700 mL of Placebo solution will be administered orally or via NG/OG/NJ/ND/PEG tube~Placebo"
44806|NCT02317549|P1|Participant Flow|Tranexemic Acid|"Daily a total of 700 mL of LB1148 solution containing 7.5 g of tranexemic acid will be administered orally or via NG/OG/NJ/ND/PEG tube~LB1148"
44807|NCT02317549|O2|Outcome|Placebo|"Daily a total of 700 mL of Placebo solution will be administered orally or via NG/OG/NJ/ND/PEG tube~Placebo"
44808|NCT02317549|O1|Outcome|Tranexemic Acid|"Daily a total of 700 mL of LB1148 solution containing 7.5 g of tranexemic acid will be administered orally or via NG/OG/NJ/ND/PEG tube~LB1148"
44809|NCT02317549|E2|Reported Event|Placebo|"Daily a total of 700 mL of Placebo solution will be administered orally or via NG/OG/NJ/ND/PEG tube~Placebo"
44810|NCT02317549|E1|Reported Event|Tranexemic Acid|"Daily a total of 700 mL of LB1148 solution containing 7.5 g of tranexemic acid will be administered orally or via NG/OG/NJ/ND/PEG tube~LB1148"
44811|NCT02317510|B3|Baseline|Total|Total of all reporting groups
44812|NCT02317510|B2|Baseline|Group 2|"Laparoscopic cholecystectomy in combined anesthesia (Spino epidural).~general anesthesia: General anesthesia for laparoscopic cholecystectomy"
44813|NCT02317510|B1|Baseline|Group 1|"Laparoscopic cholecystectomy in General Anesthesia~combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy"
44814|NCT02317510|P2|Participant Flow|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
44815|NCT02317510|P1|Participant Flow|Group 1|Laparoscopic cholecystectomy in General Anesthesia
44816|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
44817|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
44818|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
44819|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
44820|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
44821|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
44822|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
44823|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
44824|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
44825|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
44826|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
44827|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
44828|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
44829|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
44830|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
44831|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
44832|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
44833|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
44834|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
44835|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
44836|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
44837|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
44838|NCT02317510|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anesthesia (Spino epidural).~general anesthesia: General anesthesia for laparoscopic cholecystectomy"
44839|NCT02317510|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in General Anesthesia~combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy"
44840|NCT02317510|E2|Reported Event|Group 2|Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
44841|NCT02317510|E1|Reported Event|Group 1|Laparoscopic cholecystectomy in General Anesthesia
44842|NCT02317016|B1|Baseline|Rosuvastatin and AZD9291 (Part A); AZD9291 Alone (Part B)|"In Part A of the study, sequential treatments of rosuvastatin alone, followed by AZD9291 alone, followed by rosuvastatin + AZD9291. Each patient received 20 mg single oral doses of rosuvastatin on Day 1 and Day 32, and 80 mg oral doses of AZD9291 tablets once daily for 31 days (Days 4 to 34).~In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation."
44843|NCT02317016|P1|Participant Flow|Rosuvastatin and AZD9291 (Part A); AZD9291 Alone (Part B)|"In Part A of the study, sequential treatments of rosuvastatin alone, followed by AZD9291 alone, followed by rosuvastatin + AZD9291. Each patient received 20 mg single oral doses of rosuvastatin on Day 1 and Day 32, and 80 mg oral doses of AZD9291 tablets once daily for 31 days (Days 4 to 34).~In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation."
44844|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
44845|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
44846|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
44847|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
44848|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
44849|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
44850|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
44851|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
44852|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
44853|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
44854|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
44855|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
44856|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
44857|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
44858|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
44859|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
44860|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
44861|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
44862|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
44863|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
44864|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
44865|NCT02317016|E3|Reported Event|Part B Safety Population|In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation.
44866|NCT02317016|E2|Reported Event|Part A Safety Population|In Part A of the study, each patient received 80 mg oral doses of AZD9291 tablets once daily for 31 days (Days 4 to 34) and single 20 mg oral doses of rosuvastatin on Day 1 and Day 32.
44867|NCT02317016|E1|Reported Event|Overall Safety Population|Parts A and B of the study combined.
44868|NCT02316769|B3|Baseline|Total|Total of all reporting groups
44869|NCT02316769|B2|Baseline|McGrath MAC Video Laryngoscope|"Patient intubated with the McGrath MAC Video Laryngoscope~Intubation with the McGrath MAC video laryngoscope"
44870|NCT02316769|B1|Baseline|King Vision Video Laryngoscope|"Patient intubated with the King Vision Video Laryngoscope~Intubation with the King Vision video laryngoscope"
44871|NCT02316769|P2|Participant Flow|McGrath MAC Video Laryngoscope|"Patient intubated with the McGrath MAC Video Laryngoscope~Intubation with the McGrath MAC video laryngoscope"
44872|NCT02316769|P1|Participant Flow|King Vision Video Laryngoscope|"Patient intubated with the King Vision Video Laryngoscope~Intubation with the King Vision video laryngoscope"
44873|NCT02316769|O2|Outcome|McGrath MAC Video Laryngoscope|"Patient intubated with the McGrath MAC Video Laryngoscope~Intubation with the McGrath MAC video laryngoscope"
44874|NCT02316769|O1|Outcome|King Vision Video Laryngoscope|"Patient intubated with the King Vision Video Laryngoscope~Intubation with the King Vision video laryngoscope"
44875|NCT02316769|O2|Outcome|McGrath MAC Video Laryngoscope|"Patient intubated with the McGrath MAC Video Laryngoscope~Intubation with the McGrath MAC video laryngoscope"
44876|NCT02316769|O1|Outcome|King Vision Video Laryngoscope|"Patient intubated with the King Vision Video Laryngoscope~Intubation with the King Vision video laryngoscope"
44877|NCT02316769|E2|Reported Event|McGrath MAC Video Laryngoscope|"Patient intubated with the McGrath MAC Video Laryngoscope~Intubation with the McGrath MAC video laryngoscope"
44878|NCT02316769|E1|Reported Event|King Vision Video Laryngoscope|"Patient intubated with the King Vision Video Laryngoscope~Intubation with the King Vision video laryngoscope"
44879|NCT02316678|B3|Baseline|Total|Total of all reporting groups
44880|NCT02316678|B2|Baseline|Corticosteroids - no Intervention|"Patients initiating corticosteroids~No intervention: There is no intervention"
44881|NCT02316678|B1|Baseline|Anti-TNF - no Intervention|"Patients who are new users of anti-TNF therapy~No intervention: There is no intervention"
44882|NCT02316678|P2|Participant Flow|Corticosteroids - no Intervention|"Patients initiating corticosteroids~No intervention: There is no intervention"
44883|NCT02316678|P1|Participant Flow|Anti-TNF - no Intervention|"Patients who are new users of anti-TNF therapy~No intervention: There is no intervention"
44884|NCT02316678|O2|Outcome|Steroids|Prolonged users of steroids defined as either >3000 mg of prednisone (or equivalent) or >600 mg of budesonide divided between ≥2 prescriptions within 12 months and absence of any anti-TNF therapy during the same 12 months.
44885|NCT02316678|O1|Outcome|Anti-TNF|New users of anti-TNF therapy defined as ≥ 1 dispensing for an anti-TNF drug with ≥1 filled CS prescription and no dispensing for any anti-TNF medication in the 12 months preceding the first anti-TNF dispensing.
44886|NCT02316678|E2|Reported Event|Corticosteroids - no Intervention|"Patients initiating corticosteroids~No intervention: There is no intervention"
44887|NCT02316678|E1|Reported Event|Anti-TNF - no Intervention|"Patients who are new users of anti-TNF therapy~No intervention: There is no intervention"
44888|NCT02316613|B1|Baseline|All Participants|Participants with histologically confirmed, refractory/relapsed CD2 0-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
44889|NCT02316613|P1|Participant Flow|All Participants|Participants with histologically confirmed, refractory/relapsed cluster of differentiation-20 (CD20) positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
44890|NCT02316613|O2|Outcome|Maintenance Therapy|During maintenance therapy the participants received or did not received treatment with the MabThera.
44891|NCT02316613|O1|Outcome|First Induction|During the induction period participants received either MabThera monotherapy, MabThera combination therapy (chemotherapy and at least one cycle with MabThera), or all cycles performed without MabThera administration.
44892|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
44893|NCT02316613|O1|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.
44894|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.
44895|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
44896|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.
44897|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
44898|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.
44899|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
44900|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.
44901|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
44902|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period.
44903|NCT02316613|O1|Outcome|Without MabThera|Treatment without MabThera was defined as the absence of MabThera administration during maintenance therapy or observation period.
44904|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period.
44905|NCT02316613|O1|Outcome|Without MabThera|Treatment without MabThera was defined as the absence of MabThera administration during maintenance therapy or observation period.
44906|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
44907|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
44908|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
44909|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
44910|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
44911|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
44912|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
46269|NCT02308748|E5|Reported Event|Placebo|"Placebo (#2 gelcap and intravenous saline)~Placebo: Placebo (#2 Gelcap or IV saline)"
44913|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received MabThera maintenance therapy after the first study induction was reported.
44914|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received MabThera treatment over the first study induction period was reported.
44915|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
44916|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
44917|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
44918|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period.
44919|NCT02316613|O1|Outcome|Without MabThera|Treatment without MabThera was defined as the absence of MabThera administration during maintenance therapy or observation period.
44920|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period.
44921|NCT02316613|O1|Outcome|Without MabThera|Treatment without MabThera was defined as the absence of MabThera administration during maintenance therapy or observation period.
44922|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment.
44923|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD2 0-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
44924|NCT02316613|E1|Reported Event|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
44925|NCT02316548|B3|Baseline|Total|Total of all reporting groups
44926|NCT02316548|B2|Baseline|Intensity-modulated Radiation Therapy (IMRT)|Postoperative adjuvant IMRT radiotherapy 50.4 Gy in 28 fractions.
44927|NCT02316548|B1|Baseline|No Radiation Therapy|Patients do not receive radiation therapy (RT).
44928|NCT02316548|P2|Participant Flow|Intensity-modulated Radiation Therapy (IMRT)|Postoperative adjuvant IMRT radiotherapy 50.4 Gy in 28 fractions.
44929|NCT02316548|P1|Participant Flow|No Radiation Therapy|Patients do not receive radiation therapy (RT).
44930|NCT02316548|O2|Outcome|Intensity-modulated Radiation Therapy (IMRT)|Postoperative adjuvant IMRT radiotherapy 50.4 Gy in 28 fractions.
44931|NCT02316548|O1|Outcome|No Radiation Therapy|Patients do not receive radiation therapy (RT).
44932|NCT02316548|O2|Outcome|Intensity-modulated Radiation Therapy (IMRT)|Postoperative adjuvant IMRT radiotherapy 50.4 Gy in 28 fractions.
44933|NCT02316548|O1|Outcome|No Radiation Therapy|Patients do not receive radiation therapy (RT).
44934|NCT02316548|O2|Outcome|Intensity-modulated Radiation Therapy (IMRT)|Postoperative adjuvant IMRT radiotherapy 50.4 Gy in 28 fractions.
44935|NCT02316548|O1|Outcome|No Radiation Therapy|Patients do not receive radiation therapy (RT).
44936|NCT02316548|E2|Reported Event|Intensity-modulated Radiation Therapy (IMRT)|Postoperative adjuvant IMRT radiotherapy 50.4 Gy in 28 fractions.
44937|NCT02316548|E1|Reported Event|No Radiation Therapy|Patients do not receive radiation therapy (RT).
44938|NCT02316470|B5|Baseline|Total|Total of all reporting groups
44939|NCT02316470|B4|Baseline|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
44940|NCT02316470|B3|Baseline|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44941|NCT02316470|B2|Baseline|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44942|NCT02316470|B1|Baseline|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
44943|NCT02316470|P4|Participant Flow|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28~Placebo: phosphate buffered saline (PBS) solution"
44944|NCT02316470|P3|Participant Flow|VLA84 200 mcg w/ Alum|"VLA84 200 mcg w/ (with) Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44945|NCT02316470|P2|Participant Flow|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44946|NCT02316470|P1|Participant Flow|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 1 injection of 0.75 mL (milliliters) VLA84 w/o Alum and 1 injection of 0.75 mL Placebo Vaccination Days: 0, 7 and 28~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
44947|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
44948|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44949|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44950|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
44951|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
44952|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44953|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44954|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
44955|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
44956|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44957|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44958|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
44959|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
44960|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44961|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44962|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
44963|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
44964|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44965|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44966|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
44967|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
45483|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
44968|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44969|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44970|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
44971|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
44972|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44973|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44974|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
44975|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
44976|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44977|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44978|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
44979|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
44980|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44981|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44982|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
44983|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
44984|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44985|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44986|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
44987|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
44988|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44989|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44990|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
67821|NCT02153489|E2|Reported Event|Placebo|Placebo BID
44991|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
44992|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44993|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44994|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
44995|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
44996|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44997|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
44998|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
44999|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
45000|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
45001|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
45002|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
45003|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
45004|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
45005|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
45006|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
45007|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
45008|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
45009|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
45010|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
45011|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
45012|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
45013|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
45312|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
45014|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
45015|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
45016|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
45017|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
45018|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
45019|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
45020|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
45021|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
45022|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
45023|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
45024|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
45025|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
45026|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
45027|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
45028|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
45029|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
45030|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
45031|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
45032|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
45033|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
45034|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
45035|NCT02316470|E4|Reported Event|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
45036|NCT02316470|E3|Reported Event|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
46335|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
45037|NCT02316470|E2|Reported Event|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
45038|NCT02316470|E1|Reported Event|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
45039|NCT02316366|B3|Baseline|Total|Total of all reporting groups
45040|NCT02316366|B2|Baseline|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
45041|NCT02316366|B1|Baseline|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer~Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
45042|NCT02316366|P2|Participant Flow|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
45043|NCT02316366|P1|Participant Flow|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer~Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
45044|NCT02316366|O2|Outcome|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
45045|NCT02316366|O1|Outcome|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer~Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
45046|NCT02316366|O2|Outcome|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
45047|NCT02316366|O1|Outcome|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer~Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
45048|NCT02316366|O2|Outcome|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
45049|NCT02316366|O1|Outcome|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer~Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
45050|NCT02316366|E2|Reported Event|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
45051|NCT02316366|E1|Reported Event|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer~Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
45052|NCT02315989|B1|Baseline|Safety|"proton therapy~proton therapy: proton therapy"
45053|NCT02315989|P1|Participant Flow|Safety|"proton therapy~proton therapy: proton therapy"
45054|NCT02315989|O3|Outcome|Inevaluable|Inevaluable (NE), Inevaluable for response: specify reasons (for example: early death, malignant disease; toxicity; tumor assessments not repeated/incomplete; other (specify).
45055|NCT02315989|O2|Outcome|Partial Response|Partial Response(PR), At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
45056|NCT02315989|O1|Outcome|Stable Disease|Stable Disease(SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
45057|NCT02315989|O1|Outcome|The Frequency of Operation of the System Error|6 subjects received a total of 165 proton therapy, a total of 21 times the system running abnormalities. There was no correlation between system abnormalities during the study and the adverse events.
45058|NCT02315989|O1|Outcome|Safety|"proton therapy~proton therapy: proton therapy"
45059|NCT02315989|E1|Reported Event|Safety|"proton therapy~proton therapy: proton therapy"
45060|NCT02315352|B3|Baseline|Total|Total of all reporting groups
45061|NCT02315352|B2|Baseline|Rac-PZQ Then L-PZQ (Day 1)|Rac-PZQ 150 mg ODT in first intervention period followed by L-PZQ 150 mg ODT in the second intervention period. A washout period of 1 hour was maintained between the intervention periods. The intervention was directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
45062|NCT02315352|B1|Baseline|L-PZQ Then Rac-PZQ (Day 1)|L- Praziquantel (L-PZQ) 150 milligram (mg) oral disintegrating tablet (ODT) in first intervention period followed by racemate praziquantel (Rac-PZQ) 150 mg ODT in the second intervention period. A washout period of 1 hour was maintained between the intervention periods. The intervention was directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
45063|NCT02315352|P8|Participant Flow|Cesol® Then Rac-PZQ Then L-PZQ (Day 2)|Subjects who were randomized to either ‘L-PZQ Then Rac-PZQ’ or ‘Rac-PZQ Then L-PZQ’ sequence on Day 1 received Cesol® 150 mg as a suspension via a syringe in the buccal cavity in third intervention period followed by Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in fourth intervention period and then L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
45075|NCT02315352|O1|Outcome|L-PZQ (Without Water) Day 1|All subjects who received L-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
46336|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
45064|NCT02315352|P7|Participant Flow|Cesol® Then L-PZQ Then Rac-PZQ (Day 2)|Subjects who were randomized to either ‘L-PZQ Then Rac-PZQ’ or ‘Rac-PZQ Then L-PZQ’ sequence on Day 1 received Cesol® 150 mg as a suspension via a syringe in the buccal cavity in third intervention period followed by L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in fourth intervention period and then Rac -PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
45065|NCT02315352|P6|Participant Flow|Rac-PZQ Then L-PZQ Then Cesol® (Day 2)|Subjects who were randomized to either ‘L-PZQ Then Rac-PZQ’ or ‘Rac-PZQ Then L-PZQ’ sequence on Day 1 received Rac-PZQ 150 mg ODT as a solution via a syringe in the buccal cavity in third intervention period followed by L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in fourth intervention period and then Cesol® 150 mg administered as a suspension via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
45066|NCT02315352|P5|Participant Flow|Rac-PZQ Then Cesol® Then L-PZQ (Day 2)|Subjects who were randomized to either ‘L-PZQ Then Rac-PZQ’ or ‘Rac-PZQ Then L-PZQ’ sequence on Day 1 received Rac-PZQ 150 mg ODT as a solution via a syringe in the buccal cavity in third intervention period followed by Cesol® 150 mg administered as a suspension via a syringe in the buccal cavity in fourth intervention period and then L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
45067|NCT02315352|P4|Participant Flow|L-PZQ Then Cesol® Then Rac-PZQ (Day 2)|Subjects who were randomized to either ‘L-PZQ Then Rac-PZQ’ or ‘Rac-PZQ Then L-PZQ’ sequence on Day 1 received L-PZQ 150 mg ODT as a solution via a syringe in the buccal cavity in third intervention period followed by Cesol® 150 mg administered as a suspension via a syringe in the buccal cavity in fourth intervention period and then Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
45068|NCT02315352|P3|Participant Flow|L-PZQ Then Rac-PZQ Then Cesol® (Day 2)|Subjects who were randomized to either ‘L-PZQ Then Rac-PZQ’ or ‘Rac-PZQ Then L-PZQ’ sequence on Day 1 received L-PZQ 150 mg ODT as a solution via a syringe in the buccal cavity in third intervention period followed by Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in fourth intervention period and then Cesol® (currently available praziquantel tablet) 150 mg administered as a suspension via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
45069|NCT02315352|P2|Participant Flow|Rac-PZQ Then L-PZQ (Day 1)|Subjects were administered Rac-PZQ 150 mg ODT in first intervention period followed by L-PZQ 150 mg ODT in the second intervention period. A washout period of 1 hour was maintained between the intervention periods. The intervention was directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
45070|NCT02315352|P1|Participant Flow|L-PZQ Then Rac-PZQ (Day 1)|Subjects were administered L- Praziquantel (L-PZQ) 150 milligram (mg) oral disintegrating tablet (ODT) in first intervention period followed by racemate praziquantel (Rac-PZQ) 150 mg ODT in the second intervention period. A washout period of 1 hour was maintained between the intervention periods. The intervention was directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
45071|NCT02315352|O5|Outcome|Cesol® (With Water) Day 2|All subjects who received Cesol® administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles.
45072|NCT02315352|O4|Outcome|Rac-PZQ (With Water) Day 2|All subjects who received Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
45073|NCT02315352|O3|Outcome|L-PZQ (With Water) Day 2|All subjects who received L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
45074|NCT02315352|O2|Outcome|Rac-PZQ (Without Water) Day 1|All subjects who received Rac-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
45274|NCT02313558|O1|Outcome|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
45076|NCT02315352|O5|Outcome|Cesol® (With Water) Day 2|All subjects who received Cesol® administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles.
45077|NCT02315352|O4|Outcome|Rac-PZQ (With Water) Day 2|All subjects who received Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
45078|NCT02315352|O3|Outcome|L-PZQ (With Water) Day 2|All subjects who received L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
45079|NCT02315352|O2|Outcome|Rac-PZQ (Without Water) Day 1|All subjects who received Rac-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
45080|NCT02315352|O1|Outcome|L-PZQ (Without Water) Day 1|All subjects who received L-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
45081|NCT02315352|O5|Outcome|Cesol® (With Water) Day 2|All subjects who received Cesol® administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles.
45082|NCT02315352|O4|Outcome|Rac-PZQ (With Water) Day 2|All subjects who received Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
45083|NCT02315352|O3|Outcome|L-PZQ (With Water) Day 2|All subjects who received L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
45084|NCT02315352|O2|Outcome|Rac-PZQ (Without Water) Day 1|All subjects who received Rac-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
45085|NCT02315352|O1|Outcome|L-PZQ (Without Water) Day 1|All subjects who received L-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
45086|NCT02315352|O5|Outcome|Cesol® (With Water) Day 2|All subjects who received Cesol® administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles.
45087|NCT02315352|O4|Outcome|Rac-PZQ (With Water) Day 2|All subjects who received Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
45088|NCT02315352|O3|Outcome|L-PZQ (With Water) Day 2|All subjects who received L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
45089|NCT02315352|O2|Outcome|Rac-PZQ (Without Water) Day 1|All subjects who received Rac-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
45090|NCT02315352|O1|Outcome|L-PZQ (Without Water) Day 1|All subjects who received L-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
45091|NCT02315352|E5|Reported Event|Cesol® (With Water) Day 2|All subjects who received Cesol® administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles.
45092|NCT02315352|E4|Reported Event|Rac-PZQ (With Water) Day 2|All subjects who received Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
45093|NCT02315352|E3|Reported Event|L-PZQ (With Water) Day 2|All subjects who received L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
45094|NCT02315352|E2|Reported Event|Rac-PZQ (Without Water) Day 1|All subjects who received Rac-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
67822|NCT02153489|E1|Reported Event|Aclidinium|Aclidinium 400 μg BID
45095|NCT02315352|E1|Reported Event|L-PZQ (Without Water) Day 1|All subjects who received L-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
45096|NCT02314689|B1|Baseline|Intravenous (IV) Citrulline|Intravenous (IV) citrulline 20 mg/kg bolus with dose escalation of 10 mg/kg to target citrulline concentration of 100 µmol/L with a maximum dose of 60 mg/kg.
45097|NCT02314689|P1|Participant Flow|Intravenous (IV) Citrulline|Intravenous (IV) citrulline 20 mg/kg bolus with dose escalation of 10 mg/kg to target citrulline concentration of 100 µmol/L with a maximum dose of 60 mg/kg.
45098|NCT02314689|O1|Outcome|IV Citrulline|"IV citrulline 20 mg/kg bolus with dose escalation of 10 mg/kg to target citrulline concentration of 100 µmol/L with a maximum dose of 60 mg/kg.~Intravenous (IV) citrulline"
45099|NCT02314689|E1|Reported Event|Intravenous (IV) Citrulline|Intravenous (IV) citrulline 20 mg/kg bolus with dose escalation of 10 mg/kg to target citrulline concentration of 100 µmol/L with a maximum dose of 60 mg/kg.
45100|NCT02314637|B3|Baseline|Total|Total of all reporting groups
45101|NCT02314637|B2|Baseline|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea
45102|NCT02314637|B1|Baseline|Teneligliptin|Teneligliptin for 52 weeks
45103|NCT02314637|P2|Participant Flow|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea (glimepiride)
45104|NCT02314637|P1|Participant Flow|Teneligliptin|Teneligliptin for 52 weeks
45105|NCT02314637|O2|Outcome|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea
45106|NCT02314637|O1|Outcome|Teneligliptin|Teneligliptin for 52 weeks
45107|NCT02314637|O2|Outcome|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea
45108|NCT02314637|O1|Outcome|Teneligliptin|Teneligliptin for 52 weeks
45109|NCT02314637|O2|Outcome|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea
45110|NCT02314637|O1|Outcome|Teneligliptin|Teneligliptin for 52 weeks
45111|NCT02314637|E2|Reported Event|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea
45112|NCT02314637|E1|Reported Event|Teneligliptin|Teneligliptin for 52 weeks
45113|NCT02314546|B4|Baseline|Total|Total of all reporting groups
45114|NCT02314546|B3|Baseline|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
45115|NCT02314546|B2|Baseline|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
45116|NCT02314546|B1|Baseline|Saline Placebo|Control patients received intranasal saline.
45117|NCT02314546|P3|Participant Flow|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
45118|NCT02314546|P2|Participant Flow|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
45119|NCT02314546|P1|Participant Flow|Saline Placebo|Control patients received intranasal saline.
45120|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
45121|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
45122|NCT02314546|O1|Outcome|Saline Placebo|Control patients received intranasal saline.
45123|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
45124|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
45125|NCT02314546|O1|Outcome|Saline Placebo|Control patients received intranasal saline.
45126|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
45127|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
45128|NCT02314546|O1|Outcome|Saline Placebo|Control patients will received intranasal saline.
45129|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
45130|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
45131|NCT02314546|O1|Outcome|Saline Placebo|Control patients received intranasal saline.
45132|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
45133|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
45134|NCT02314546|O1|Outcome|Saline Placebo|Control patients received intranasal saline.
45135|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
45136|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
45137|NCT02314546|O1|Outcome|Saline Placebo|Control patients received intranasal saline.
45138|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
45139|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
45140|NCT02314546|O1|Outcome|Saline Placebo|Control patients received intranasal saline.
45141|NCT02314546|E3|Reported Event|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
45142|NCT02314546|E2|Reported Event|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
45143|NCT02314546|E1|Reported Event|Saline Placebo|Control patients received intranasal saline.
45144|NCT02314520|B3|Baseline|Total|Total of all reporting groups
45145|NCT02314520|B2|Baseline|Central Line|"Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.~centrally inserted central catheter: Central access not associated with any complication"
45146|NCT02314520|B1|Baseline|PICC|"Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.~peripherally inserted central catheter: Any complication associated with central access"
45147|NCT02314520|P2|Participant Flow|Central Line|"Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.~centrally inserted central catheter: Central access not associated with any complication"
45148|NCT02314520|P1|Participant Flow|PICC|"Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.~peripherally inserted central catheter: Any complication associated with central access"
45149|NCT02314520|O2|Outcome|Central Line|"Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.~centrally inserted central catheter: Central access not associated with any complication"
45150|NCT02314520|O1|Outcome|PICC|"Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.~peripherally inserted central catheter: Any complication associated with central access"
45151|NCT02314520|O2|Outcome|Central Line|"Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.~centrally inserted central catheter: Central access not associated with any complication"
45152|NCT02314520|O1|Outcome|PICC|"Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.~peripherally inserted central catheter: Any complication associated with central access"
45153|NCT02314520|O2|Outcome|Central Line|"Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.~centrally inserted central catheter: Central access not associated with any complication"
45154|NCT02314520|O1|Outcome|PICC|"Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.~peripherally inserted central catheter: Any complication associated with central access"
45155|NCT02314520|O2|Outcome|Central Line|"Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.~centrally inserted central catheter: Central access not associated with any complication"
45156|NCT02314520|O1|Outcome|PICC|"Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.~peripherally inserted central catheter: Any complication associated with central access"
45157|NCT02314520|E2|Reported Event|Central Line|"Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.~centrally inserted central catheter: Central access not associated with any complication"
45158|NCT02314520|E1|Reported Event|PICC|"Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.~peripherally inserted central catheter: Any complication associated with central access"
45159|NCT02314260|B1|Baseline|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.~bishop score calculation: Assessment of bishop score by vaginal examination~Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.~Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score~labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
45160|NCT02314260|P1|Participant Flow|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.~bishop score calculation: Assessment of bishop score by vaginal examination~Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.~Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score~labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
45161|NCT02314260|O1|Outcome|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.~bishop score calculation: Assessment of bishop score by vaginal examination~Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.~Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score~labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
45162|NCT02314260|O1|Outcome|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.~bishop score calculation: Assessment of bishop score by vaginal examination~Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.~Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score~labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
45163|NCT02314260|O1|Outcome|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.~bishop score calculation: Assessment of bishop score by vaginal examination~Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.~Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score~labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
45164|NCT02314260|O1|Outcome|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.~bishop score calculation: Assessment of bishop score by vaginal examination~Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.~Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score~labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
47838|NCT02292537|P1|Participant Flow|Sham Procedure|Sham comparator on Days 1, 29, 85 and 274.
45165|NCT02314260|E1|Reported Event|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.~bishop score calculation: Assessment of bishop score by vaginal examination~Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.~Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score~labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
45166|NCT02314117|B3|Baseline|Total|Total of all reporting groups
45167|NCT02314117|B2|Baseline|Placebo + Cisplatin + Capecitabine|Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
45168|NCT02314117|B1|Baseline|Ramucirumab + Cisplatin + Capecitabine|8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
45169|NCT02314117|P2|Participant Flow|Placebo + Cisplatin + Capecitabine|Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
45170|NCT02314117|P1|Participant Flow|Ramucirumab + Cisplatin + Capecitabine|8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
45171|NCT02314117|O1|Outcome|Ramucirumab + Cisplatin + Capecitabine|8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
45172|NCT02314117|O1|Outcome|Ramucirumab + Cisplatin + Capecitabine|8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
45173|NCT02314117|O2|Outcome|Placebo + Cisplatin + Capecitabine|Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
45174|NCT02314117|O1|Outcome|Ramucirumab + Cisplatin + Capecitabine|8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
45175|NCT02314117|O2|Outcome|Placebo + Cisplatin + Capecitabine|Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
45176|NCT02314117|O1|Outcome|Ramucirumab + Cisplatin + Capecitabine|8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
45177|NCT02314117|O2|Outcome|Placebo + Cisplatin + Capecitabine|Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
45178|NCT02314117|O1|Outcome|Ramucirumab + Cisplatin + Capecitabine|8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
45179|NCT02314117|O2|Outcome|Placebo + Cisplatin + Capecitabine|Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
45180|NCT02314117|O1|Outcome|Ramucirumab + Cisplatin + Capecitabine|8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
45181|NCT02314117|O2|Outcome|Placebo + Cisplatin + Capecitabine|Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
45275|NCT02313558|E2|Reported Event|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
45182|NCT02314117|O1|Outcome|Ramucirumab + Cisplatin + Capecitabine|8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
45183|NCT02314117|O2|Outcome|Placebo + Cisplatin + Capecitabine|Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21 day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that are unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21 day cycle.
45184|NCT02314117|O1|Outcome|Ramucirumab + Cisplatin + Capecitabine|8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
45185|NCT02314117|O2|Outcome|Placebo + Cisplatin + Capecitabine|Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21 day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that are unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21 day cycle.
45186|NCT02314117|O1|Outcome|Ramucirumab + Cisplatin + Capecitabine|8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
45187|NCT02314117|O2|Outcome|Placebo + Cisplatin + Capecitabine|Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
45188|NCT02314117|O1|Outcome|Ramucirumab + Cisplatin + Capecitabine|8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
45189|NCT02314117|O2|Outcome|Placebo + Cisplatin + Capecitabine|Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
45190|NCT02314117|O1|Outcome|Ramucirumab + Cisplatin + Capecitabine|8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
45191|NCT02314117|O2|Outcome|Placebo + Cisplatin + Capecitabine|Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
45192|NCT02314117|O1|Outcome|Ramucirumab + Cisplatin + Capecitabine|8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
45193|NCT02314117|O2|Outcome|Placebo + Cisplatin + Capecitabine|Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
45194|NCT02314117|O1|Outcome|Ramucirumab + Cisplatin + Capecitabine|8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
45195|NCT02314117|E2|Reported Event|Placebo + Cisplatin + Capecitabine|Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
45196|NCT02314117|E1|Reported Event|Ramucirumab + Cisplatin + Capecitabine|8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
45197|NCT02314104|B4|Baseline|Total|Total of all reporting groups
45198|NCT02314104|B3|Baseline|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
45199|NCT02314104|B2|Baseline|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
45200|NCT02314104|B1|Baseline|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
45201|NCT02314104|P3|Participant Flow|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
45202|NCT02314104|P2|Participant Flow|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
45203|NCT02314104|P1|Participant Flow|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
45204|NCT02314104|O3|Outcome|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
45205|NCT02314104|O2|Outcome|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
45206|NCT02314104|O1|Outcome|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
45207|NCT02314104|O3|Outcome|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
45208|NCT02314104|O2|Outcome|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
45209|NCT02314104|O1|Outcome|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
45210|NCT02314104|O3|Outcome|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
45211|NCT02314104|O2|Outcome|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
45212|NCT02314104|O1|Outcome|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
45213|NCT02314104|O3|Outcome|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
45214|NCT02314104|O2|Outcome|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
45215|NCT02314104|O1|Outcome|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
45216|NCT02314104|O3|Outcome|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
45217|NCT02314104|O2|Outcome|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
45218|NCT02314104|O1|Outcome|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
45219|NCT02314104|E3|Reported Event|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
45220|NCT02314104|E2|Reported Event|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
48003|NCT02291861|O1|Outcome|Placebo|Placebo tablets taken twice daily for 12 weeks.
45221|NCT02314104|E1|Reported Event|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
45222|NCT02313766|B4|Baseline|Total|Total of all reporting groups
45223|NCT02313766|B3|Baseline|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%~PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
45224|NCT02313766|B2|Baseline|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%~PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
45225|NCT02313766|B1|Baseline|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.~End of preoxygenation FEO2=90%"
45226|NCT02313766|P3|Participant Flow|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%~PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
45227|NCT02313766|P2|Participant Flow|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%~PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
45228|NCT02313766|P1|Participant Flow|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.~End of preoxygenation FEO2=90%"
45229|NCT02313766|O3|Outcome|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%~PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
45230|NCT02313766|O2|Outcome|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%~PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
45231|NCT02313766|O1|Outcome|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.~End of preoxygenation FEO2=90%"
45232|NCT02313766|O3|Outcome|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%~PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
45233|NCT02313766|O2|Outcome|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%~PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
45234|NCT02313766|O1|Outcome|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.~End of preoxygenation FEO2=90%"
45235|NCT02313766|O3|Outcome|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%~PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
45276|NCT02313558|E1|Reported Event|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
45277|NCT02313233|B3|Baseline|Total|Total of all reporting groups
45313|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
45236|NCT02313766|O2|Outcome|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%~PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
45237|NCT02313766|O1|Outcome|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.~End of preoxygenation FEO2=90%"
45238|NCT02313766|E3|Reported Event|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%~PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
45239|NCT02313766|E2|Reported Event|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%~PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
45240|NCT02313766|E1|Reported Event|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.~End of preoxygenation FEO2=90%"
45241|NCT02313675|B5|Baseline|Total|Total of all reporting groups
45242|NCT02313675|B4|Baseline|Saline|"One time intra-operative 50ml IV normal saline administration~Saline"
45243|NCT02313675|B3|Baseline|IV Tylenol/Toradol Combination|"One time intra-operative IV combination of acetaminophen/ketorolac administration~Acetaminophen~Ketorolac Tromethamine"
45244|NCT02313675|B2|Baseline|IV Toradol|"One time intra-operative IV ketorolac thromethamine administration~Ketorolac Tromethamine"
45245|NCT02313675|B1|Baseline|IV Tylenol|"One time intra-operative IV acetaminophen administration~Acetaminophen"
45246|NCT02313675|P4|Participant Flow|Saline|"One time intra-operative 50ml IV normal saline administration~Saline"
45247|NCT02313675|P3|Participant Flow|IV Tylenol/Toradol Combination|"One time intra-operative IV combination of acetaminophen/ketorolac administration~Acetaminophen~Ketorolac Tromethamine"
45248|NCT02313675|P2|Participant Flow|IV Toradol|"One time intra-operative IV ketorolac thromethamine administration~Ketorolac Tromethamine"
45249|NCT02313675|P1|Participant Flow|IV Tylenol|"One time intra-operative IV acetaminophen administration~Acetaminophen"
45250|NCT02313675|O4|Outcome|Saline|"One time intra-operative 50ml IV normal saline administration~Saline"
45251|NCT02313675|O3|Outcome|IV Tylenol/Toradol Combination|"One time intra-operative IV combination of acetaminophen/ketorolac administration~Acetaminophen~Ketorolac Tromethamine"
45252|NCT02313675|O2|Outcome|IV Toradol|"One time intra-operative IV ketorolac thromethamine administration~Ketorolac Tromethamine"
45253|NCT02313675|O1|Outcome|IV Tylenol|"One time intra-operative IV acetaminophen administration~Acetaminophen"
45254|NCT02313675|O4|Outcome|Saline|"One time intra-operative 50ml IV normal saline administration~Saline"
45255|NCT02313675|O3|Outcome|IV Tylenol/Toradol Combination|"One time intra-operative IV combination of acetaminophen/ketorolac administration~Acetaminophen~Ketorolac Tromethamine"
45256|NCT02313675|O2|Outcome|IV Toradol|"One time intra-operative IV ketorolac thromethamine administration~Ketorolac Tromethamine"
45257|NCT02313675|O1|Outcome|IV Tylenol|"One time intra-operative IV acetaminophen administration~Acetaminophen"
45258|NCT02313675|E4|Reported Event|Saline|"One time intra-operative 50ml IV normal saline administration~Saline"
45259|NCT02313675|E3|Reported Event|IV Tylenol/Toradol Combination|"One time intra-operative IV combination of acetaminophen/ketorolac administration~Acetaminophen~Ketorolac Tromethamine"
45260|NCT02313675|E2|Reported Event|IV Toradol|"One time intra-operative IV ketorolac thromethamine administration~Ketorolac Tromethamine"
45261|NCT02313675|E1|Reported Event|IV Tylenol|"One time intra-operative IV acetaminophen administration~Acetaminophen"
45262|NCT02313558|B3|Baseline|Total|Total of all reporting groups
45263|NCT02313558|B2|Baseline|Control Dentifrice|"use the control dentifrice to brush teeth twice daily for 12 weeks~Control dentifrice: Use the dentifrice to brush teeth twice a day for 12 weeks"
45264|NCT02313558|B1|Baseline|Dentifrice Containing Ilex Rotunda Thunb|"use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks~Dentifrice Containing Ilex Rotunda Thunb: Use the dentifrice to brush teeth twice a day for 12 weeks"
45265|NCT02313558|P2|Participant Flow|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
45266|NCT02313558|P1|Participant Flow|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
45267|NCT02313558|O2|Outcome|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
45268|NCT02313558|O1|Outcome|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
45269|NCT02313558|O2|Outcome|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
45270|NCT02313558|O1|Outcome|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
45271|NCT02313558|O2|Outcome|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
45272|NCT02313558|O1|Outcome|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
45273|NCT02313558|O2|Outcome|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
45278|NCT02313233|B2|Baseline|Placebo|Cornstarch is used as placebo. It's taken for the subjects who are diagnosed as benign prostate hyperplasia (BPH) and given medication only once a day before going to bed. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
45279|NCT02313233|B1|Baseline|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extract 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. The study product is given as add- on therapy in BPH. All the eligible subjects included in this study have the history for benign prostate hyperplasia (BPH) and receive the medication for this condition. Each subject receives the Umooze in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
45280|NCT02313233|P2|Participant Flow|Placebo|Cornstarch is used as placebo. It's taken for the subjects who are diagnosed as benign prostate hyperplasia (BPH) and given medication only once a day before going to bed. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
45281|NCT02313233|P1|Participant Flow|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extract 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is given as add-on therapy for benigh prostate hyperplasia (BPH). All the subjects have the history for this medical condition and receive the medication. Each subject receives Umooze in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
45282|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
45283|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. The study product is given as add- on therapy in BPH. All the eligible subjects included in this study have the history for benign prostate hyperplasia (BPH) and receive the medication for this condition. Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of the study product was given 2 tablets with about 240 ml of water."
45284|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
45285|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. The study product is given as add- on therapy in BPH. All the eligible subjects included in this study have the history for benign prostate hyperplasia (BPH) and receive the medication for this condition. Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
45286|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
45287|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
45288|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
45289|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
45290|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
45311|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
45291|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
45292|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
45293|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
45294|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
45295|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
45296|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
45297|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
45298|NCT02313233|E2|Reported Event|Placebo|Cornstarch is used as placebo. It's taken for the subjects who are diagnosed as benign prostate hyperplasia (BPH) and given medication only once a day before going to bed. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
45299|NCT02313233|E1|Reported Event|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extract 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
45300|NCT02313155|B3|Baseline|Total|Total of all reporting groups
45301|NCT02313155|B2|Baseline|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
45302|NCT02313155|B1|Baseline|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
45303|NCT02313155|P2|Participant Flow|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
45304|NCT02313155|P1|Participant Flow|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
45305|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
45306|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
45307|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
45308|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
45309|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
45310|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
45314|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
45315|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
45316|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
45317|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
45318|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
45319|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
45320|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
45321|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
45322|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
45323|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
45324|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
45325|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
45326|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
45327|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
45328|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
45329|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
45330|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
45331|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
45332|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
45333|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
45334|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
45335|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
45336|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
45337|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
45338|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
45339|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
45340|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
45341|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
45342|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
45343|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
45344|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
45345|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
45346|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
45347|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
45348|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
45349|NCT02313155|E2|Reported Event|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
45950|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45350|NCT02313155|E1|Reported Event|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
45351|NCT02312882|B1|Baseline|Treatment Arm|Tofacitinib (5 mg tablet taken by mouth twice a day) for 3 months.
45352|NCT02312882|P1|Participant Flow|Tofacitinib|Tofacitinib (5 mg tablet taken by mouth twice a day) for 3 months.
45353|NCT02312882|O1|Outcome|Treatment Arm|Tofacitinib (5 mg tablet taken by mouth twice a day) for 3 months.
45354|NCT02312882|E1|Reported Event|Treatment Arm|Tofacitinib (5 mg tablet taken by mouth twice a day) for 3 months.
45355|NCT02312739|B3|Baseline|Total|Total of all reporting groups
45356|NCT02312739|B2|Baseline|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
45357|NCT02312739|B1|Baseline|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
45358|NCT02312739|P2|Participant Flow|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
45359|NCT02312739|P1|Participant Flow|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
45360|NCT02312739|O2|Outcome|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
45361|NCT02312739|O1|Outcome|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
45362|NCT02312739|O2|Outcome|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
45363|NCT02312739|O1|Outcome|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
45376|NCT02312726|O2|Outcome|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
45364|NCT02312739|O2|Outcome|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
45365|NCT02312739|O1|Outcome|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
45366|NCT02312739|O2|Outcome|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
45367|NCT02312739|O1|Outcome|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
45368|NCT02312739|O2|Outcome|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
45369|NCT02312739|O1|Outcome|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
45370|NCT02312739|E2|Reported Event|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
45371|NCT02312739|E1|Reported Event|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
45372|NCT02312726|B1|Baseline|Total Participants Enrolled in Study|Participant characteristics for those enrolled in the study, in both the epidural and non-epidural group
45373|NCT02312726|P3|Participant Flow|Excluded|Participants who did not meet inclusion criteria or declined after consent.
45374|NCT02312726|P2|Participant Flow|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
45375|NCT02312726|P1|Participant Flow|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
46053|NCT02310581|B4|Baseline|Placebo|Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
45377|NCT02312726|O1|Outcome|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion.~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
45378|NCT02312726|O2|Outcome|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
45379|NCT02312726|O1|Outcome|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion.~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
45380|NCT02312726|O2|Outcome|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
45381|NCT02312726|O1|Outcome|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
45382|NCT02312726|O2|Outcome|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
45383|NCT02312726|O1|Outcome|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion.~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
45384|NCT02312726|E2|Reported Event|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
45385|NCT02312726|E1|Reported Event|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
45386|NCT02312713|B4|Baseline|Total|Total of all reporting groups
45387|NCT02312713|B3|Baseline|Wait List Control|no intervention
45388|NCT02312713|B2|Baseline|Internet Based Exercise Training|"Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals’ functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.~Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content."
45389|NCT02312713|B1|Baseline|Standard Physical Therapy|"Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be “semi-standardized,” meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.~Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises."
45390|NCT02312713|P3|Participant Flow|Wait List Control|no intervention
45391|NCT02312713|P2|Participant Flow|Internet Based Exercise Training|"Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals’ functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.~Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content."
45392|NCT02312713|P1|Participant Flow|Standard Physical Therapy|"Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be “semi-standardized,” meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.~Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises."
45393|NCT02312713|O3|Outcome|Wait List Control|no intervention
45471|NCT02311907|B2|Baseline|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
45472|NCT02311907|B1|Baseline|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
45473|NCT02311907|P2|Participant Flow|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
45394|NCT02312713|O2|Outcome|Internet Based Exercise Training|"Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals’ functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.~Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content."
45395|NCT02312713|O1|Outcome|Standard Physical Therapy|"Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be “semi-standardized,” meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.~Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises."
45396|NCT02312713|O3|Outcome|Wait List Control|no intervention
45397|NCT02312713|O2|Outcome|Internet Based Exercise Training|"Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals’ functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.~Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content."
45398|NCT02312713|O1|Outcome|Standard Physical Therapy|"Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be “semi-standardized,” meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.~Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises."
45399|NCT02312713|O3|Outcome|Wait List Control|no intervention
45400|NCT02312713|O2|Outcome|Internet Based Exercise Training|"Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals’ functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.~Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content."
45401|NCT02312713|O1|Outcome|Standard Physical Therapy|"Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be “semi-standardized,” meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.~Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises."
45402|NCT02312713|O3|Outcome|Wait List Control|no intervention
45403|NCT02312713|O2|Outcome|Internet Based Exercise Training|"Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals’ functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.~Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content."
45404|NCT02312713|O1|Outcome|Standard Physical Therapy|"Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be “semi-standardized,” meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.~Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises."
45405|NCT02312713|O3|Outcome|Wait List Control|no intervention
45474|NCT02311907|P1|Participant Flow|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
45475|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
45586|NCT02310750|P2|Participant Flow|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45406|NCT02312713|O2|Outcome|Internet Based Exercise Training|"Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals’ functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.~Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content."
45407|NCT02312713|O1|Outcome|Standard Physical Therapy|"Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be “semi-standardized,” meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.~Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises."
45408|NCT02312713|O3|Outcome|Wait List Control|no intervention
45409|NCT02312713|O2|Outcome|Internet Based Exercise Training|"Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals’ functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.~Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content."
45410|NCT02312713|O1|Outcome|Standard Physical Therapy|"Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be “semi-standardized,” meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.~Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises."
45411|NCT02312713|O3|Outcome|Wait List Control|no intervention
45412|NCT02312713|O2|Outcome|Internet Based Exercise Training|"Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals’ functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.~Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content."
45413|NCT02312713|O1|Outcome|Standard Physical Therapy|"Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be “semi-standardized,” meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.~Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises."
45414|NCT02312713|O3|Outcome|Wait List Control|no intervention
45415|NCT02312713|O2|Outcome|Internet Based Exercise Training|"Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals’ functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.~Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content."
45416|NCT02312713|O1|Outcome|Standard Physical Therapy|"Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be “semi-standardized,” meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.~Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises."
45417|NCT02312713|O3|Outcome|Wait List Control|no intervention
45476|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
45477|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
45587|NCT02310750|P1|Participant Flow|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45418|NCT02312713|O2|Outcome|Internet Based Exercise Training|"Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals’ functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.~Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content."
45419|NCT02312713|O1|Outcome|Standard Physical Therapy|"Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be “semi-standardized,” meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.~Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises."
45420|NCT02312713|O3|Outcome|Wait List Control|no intervention
45421|NCT02312713|O2|Outcome|Internet Based Exercise Training|"Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals’ functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.~Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content."
45422|NCT02312713|O1|Outcome|Standard Physical Therapy|"Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be “semi-standardized,” meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.~Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises."
45423|NCT02312713|O3|Outcome|Wait List Control|no intervention
45424|NCT02312713|O2|Outcome|Internet Based Exercise Training|"Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals’ functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.~Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content."
45425|NCT02312713|O1|Outcome|Standard Physical Therapy|"Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be “semi-standardized,” meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.~Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises."
45426|NCT02312713|O3|Outcome|Wait List Control|no intervention
45427|NCT02312713|O2|Outcome|Internet Based Exercise Training|"Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals’ functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.~Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content."
45428|NCT02312713|O1|Outcome|Standard Physical Therapy|"Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be “semi-standardized,” meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.~Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises."
45429|NCT02312713|O3|Outcome|Wait List Control|no intervention
45478|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
45479|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
45588|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45430|NCT02312713|O2|Outcome|Internet Based Exercise Training|"Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals’ functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.~Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content."
45431|NCT02312713|O1|Outcome|Standard Physical Therapy|"Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be “semi-standardized,” meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.~Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises."
45432|NCT02312713|E3|Reported Event|Wait List Control|no intervention
45433|NCT02312713|E2|Reported Event|Internet Based Exercise Training|"Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals’ functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.~Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content."
45434|NCT02312713|E1|Reported Event|Standard Physical Therapy|"Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be “semi-standardized,” meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.~Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises."
45435|NCT02312154|B1|Baseline|Restylane Vital|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
45436|NCT02312154|P1|Participant Flow|Restylane Vital|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
45437|NCT02312154|O2|Outcome|Untreated Side|Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
45438|NCT02312154|O1|Outcome|Treated Side (Restylane Vital)|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
45439|NCT02312154|O2|Outcome|Untreated Side|Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
45440|NCT02312154|O1|Outcome|Treated Side (Restylane Vital)|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
45441|NCT02312154|O2|Outcome|Untreated Side|Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
45442|NCT02312154|O1|Outcome|Treated Side (Restylane Vital)|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
45443|NCT02312154|O2|Outcome|Untreated Side|Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
45444|NCT02312154|O1|Outcome|Treated Side (Restylane Vital)|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
45445|NCT02312154|O2|Outcome|Untreated Side|Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
45446|NCT02312154|O1|Outcome|Treated Side (Restylane Vital)|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
45447|NCT02312154|O2|Outcome|Untreated Side|Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
45448|NCT02312154|O1|Outcome|Treated Side (Restylane Vital)|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
45449|NCT02312154|E1|Reported Event|Restylane Vital|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
45450|NCT02311972|B3|Baseline|Total|Total of all reporting groups
45480|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
45481|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
46206|NCT02309723|E2|Reported Event|Negative Beta Amyloid Findings|"Beta amyloid imaging results indicated a negative finding.~Beta amyloid imaging"
45451|NCT02311972|B2|Baseline|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|The nurse will insert an InnerSense temperature sensor/feeding tube per normal standards as soon after birth as possible, during delivery room stabilization. Nurses will record an axillary temperature upon admission to the NICU, and at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life. All temperatures entered into the study database.
45452|NCT02311972|B1|Baseline|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on admission, and at 1, 4, 8 and 24 hours. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures. Nurses will record an axillary temperature upon admission to the NICU, and at 1, 4, 8 and 24 hours of age for each infant in both groups on a data sheet at the bedside. These data will be entered into a RedCap data base created for the study.
45453|NCT02311972|P2|Participant Flow|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
45454|NCT02311972|P1|Participant Flow|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
45455|NCT02311972|O1|Outcome|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|The nurse will insert an InnerSense temperature sensor/feeding tube per normal standards as soon after birth as possible, during delivery room stabilization. Nurses will record an axillary temperature upon admission to the NICU, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
45456|NCT02311972|O2|Outcome|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
45457|NCT02311972|O1|Outcome|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
45458|NCT02311972|O2|Outcome|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
45459|NCT02311972|O1|Outcome|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
45482|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
45460|NCT02311972|O2|Outcome|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
45461|NCT02311972|O1|Outcome|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
45462|NCT02311972|O2|Outcome|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
45463|NCT02311972|O1|Outcome|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
45464|NCT02311972|O2|Outcome|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
45465|NCT02311972|O1|Outcome|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
45466|NCT02311972|O2|Outcome|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
45467|NCT02311972|O1|Outcome|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
45468|NCT02311972|E2|Reported Event|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
45469|NCT02311972|E1|Reported Event|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
45470|NCT02311907|B3|Baseline|Total|Total of all reporting groups
45484|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
45485|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
45486|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
45487|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
45488|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
45489|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
45490|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
45491|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
45492|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
45493|NCT02311907|E2|Reported Event|B (Placebo, Paclitaxel)|Quality-of-Life Assessment: Ancillary studies
45494|NCT02311907|E1|Reported Event|A (Glutathione, Carboplatin)|Quality-of-Life Assessment: Ancillary studies
45495|NCT02311881|B4|Baseline|Total|Total of all reporting groups
45496|NCT02311881|B3|Baseline|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45497|NCT02311881|B2|Baseline|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45498|NCT02311881|B1|Baseline|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45499|NCT02311881|P3|Participant Flow|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45500|NCT02311881|P2|Participant Flow|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45501|NCT02311881|P1|Participant Flow|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 milligram (mg) sustained release (SR) tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 milliliter [mL]) of water/dose for 12 weeks.
45502|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45503|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45504|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45505|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45506|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45507|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45655|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45508|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45509|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45510|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45511|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45512|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45513|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45514|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces (~ 240 mL) of water/dose for 12 weeks.
45515|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces (~ 240 mL) of water/dose for 12 weeks.
45516|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces (~ 240 mL) of water/dose for 12 weeks.
45517|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45518|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45519|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45520|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45521|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45522|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45523|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45524|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45525|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45526|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45656|NCT02310750|O5|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45527|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45528|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45529|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45530|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45531|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45532|NCT02311881|E3|Reported Event|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45533|NCT02311881|E2|Reported Event|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45534|NCT02311881|E1|Reported Event|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
45535|NCT02311309|B4|Baseline|Total|Total of all reporting groups
45536|NCT02311309|B3|Baseline|No Peroperative Significant Bleeding|Patients for whom surgery did not result in significant bleeding
45537|NCT02311309|B2|Baseline|Unanticipated Bleeding|"Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.~Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL."
45538|NCT02311309|B1|Baseline|Control|"Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.~Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL."
45539|NCT02311309|P3|Participant Flow|No Significant Bleeding|Patients in whom surgery did not resulted in significant bleeding
45540|NCT02311309|P2|Participant Flow|Unanticipated Bleeding|"Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.~Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL."
45541|NCT02311309|P1|Participant Flow|Control|"Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.~Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL."
45542|NCT02311309|O3|Outcome|No Significant Bleeding|Patients in whom surgery did not resulted in significant bleeding
45543|NCT02311309|O2|Outcome|Unanticipated Bleeding|"Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.~Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL."
45544|NCT02311309|O1|Outcome|Control|"Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.~Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL."
45545|NCT02311309|O3|Outcome|No Significant Bleeding|Patients in whom surgery did not resulted in significant bleeding
45546|NCT02311309|O2|Outcome|Unanticipated Bleeding|"Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.~Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL."
45547|NCT02311309|O1|Outcome|Control|"Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.~Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL."
45548|NCT02311309|E3|Reported Event|No Peroperative Significant Bleeding|Patients for whom surgery did not result in significant bleeding
45549|NCT02311309|E2|Reported Event|Unanticipated Bleeding|"Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.~Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL."
45550|NCT02311309|E1|Reported Event|Control|"Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.~Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL."
46337|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
45551|NCT02310789|B1|Baseline|Ivacaftor|Participants received ivacaftor orally for 3 days, followed by 35 days off drug. Participants repeated this cycle then received ivacaftor for 3 additional days. For sweat testing, participants received β-adrenergic cocktail to stimulated sweating, at both 1% stimulation strength and full stimulation strength. Each participant also received pilocarpine nitrate 5% administered by Macroduct sweat stimulator device. Sweat stimulation testing was done on- and off-ivacaftor.
45552|NCT02310789|P1|Participant Flow|Ivacaftor|Participants received ivacaftor orally for 3 days, followed by 35 days off drug. Participants repeated this cycle then received ivacaftor for 3 additional days. For sweat testing, participants received β-adrenergic cocktail to stimulated sweating, at both 1% stimulation strength and full stimulation strength. Each participant also received pilocarpine nitrate 5% administered by Macroduct sweat stimulator device. Sweat stimulation testing was done on- and off-ivacaftor.
45553|NCT02310789|O1|Outcome|Ivacaftor|Participants received ivacaftor orally for 3 days, followed by 35 days off drug. Participants repeated this cycle then received ivacaftor for 3 additional days. For sweat testing, participants received β-adrenergic cocktail to stimulated sweating, at both 1% stimulation strength and full stimulation strength. Each participant also received pilocarpine nitrate 5% administered by Macroduct sweat stimulator device. Sweat stimulation testing was done on- and off-ivacaftor.
45554|NCT02310789|O1|Outcome|Ivacaftor|Participants received ivacaftor orally for 3 days, followed by 35 days off drug. Participants repeated this cycle then received ivacaftor for 3 additional days. For sweat testing, participants received β-adrenergic cocktail to stimulated sweating, at both 1% stimulation strength and full stimulation strength. Each participant also received pilocarpine nitrate 5% administered by Macroduct sweat stimulator device. Sweat stimulation testing was done on- and off-ivacaftor.
45555|NCT02310789|E1|Reported Event|Ivacaftor|Participants received ivacaftor orally for 3 days, followed by 35 days off drug. Participants repeated this cycle then received ivacaftor for 3 additional days. For sweat testing, participants received β-adrenergic cocktail to stimulated sweating, at both 1% stimulation strength and full stimulation strength. Each participant also received pilocarpine nitrate 5% administered by Macroduct sweat stimulator device. Sweat stimulation testing was done on- and off-ivacaftor.
45556|NCT02310776|B1|Baseline|Automated & Handheld Beast US Exams|"Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner; Supine automated breast ultrasound scanner: Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.~Handheld breast ultrasound exam: High-resolution handheld breast ultrasound; Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist"
45557|NCT02310776|P1|Participant Flow|Automated & Handheld Breast US Exams|"Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner; Supine automated breast ultrasound scanner: Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.~Handheld breast ultrasound exam: High-resolution handheld breast ultrasound; Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist"
45558|NCT02310776|O1|Outcome|Automated & Handheld Breast US Exams|"Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner; Supine automated breast ultrasound scanner: Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.~Handheld breast ultrasound exam: High-resolution handheld breast ultrasound; Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist"
45559|NCT02310776|E1|Reported Event|Automated & Handheld Breast US Exams|"Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner; Supine automated breast ultrasound scanner: Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.~Handheld breast ultrasound exam: High-resolution handheld breast ultrasound; Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist"
45560|NCT02310750|B12|Baseline|Total|Total of all reporting groups
45561|NCT02310750|B11|Baseline|PF-06700841: 100 mg Food Effect Cohort|All participants who received either PF-06700841 100 mg tablet under fasted condition or PF-06700841 100 mg tablet under fed condition or PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in any 1 of the 6 treatment sequences in food effects cohort of the study.
45562|NCT02310750|B10|Baseline|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45563|NCT02310750|B9|Baseline|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45564|NCT02310750|B8|Baseline|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45565|NCT02310750|B7|Baseline|Placebo: SAD Cohort Then MAD Cohort|Healthy participants received placebo matched to PF-06700841 single tablet orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then placebo matched to PF-06700841 tablet once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days) followed by washout period of at least 7 days followed by placebo matched to PF-06700841 tablet twice daily from Day 1 to Day 10 in the treatment period 3 for MAD cohort (28 days).
45566|NCT02310750|B6|Baseline|PF-­06700841: 200 mg SAD Cohort, 175 mg MAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 175 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
45567|NCT02310750|B5|Baseline|PF­-06700841: 100 mg SAD, 100 mg MAD, 50 mg MAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 100 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days) followed by washout period of at least 7 days, then PF-06700841 tablet 50 mg orally, twice daily from Day 1 to Day 10 in the treatment period 3 for MAD cohort (28 days).
45689|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45568|NCT02310750|B4|Baseline|PF-06700841: 30 mg SAD Cohort Then MAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 30 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
45569|NCT02310750|B3|Baseline|PF­-06700841: 10 mg SAD Cohort Then MAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 10 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
45570|NCT02310750|B2|Baseline|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45571|NCT02310750|B1|Baseline|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45572|NCT02310750|P16|Participant Flow|PF-06700841: 100 mg Tablet Fed, Tablet Fasted, Solution Fasted|Participants received PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
45573|NCT02310750|P15|Participant Flow|PF-06700841: 100 mg Solution Fasted, Tablet Fed, Tablet Fasted|Participants received PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
45574|NCT02310750|P14|Participant Flow|PF-06700841: 100 mg Tablet Fasted, Solution Fasted, Tablet Fed|Participants received PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
45575|NCT02310750|P13|Participant Flow|PF-06700841: 100 mg Tablet Fed, Solution Fasted, Tablet Fasted|Participants received PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
45576|NCT02310750|P12|Participant Flow|PF-06700841: 100 mg Solution Fasted, Tablet Fasted, Tablet Fed|Participants received PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
45577|NCT02310750|P11|Participant Flow|PF-06700841: 100 mg Tablet Fasted, Tablet Fed, Solution Fasted|Participants received PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 2 (9 days) followed by second washout period (5 days) followed by PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
45578|NCT02310750|P10|Participant Flow|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45579|NCT02310750|P9|Participant Flow|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45580|NCT02310750|P8|Participant Flow|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45581|NCT02310750|P7|Participant Flow|Placebo: SAD Cohort Then MAD Cohort|Healthy participants received placebo matched to PF-06700841 single tablet orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then placebo matched to PF-06700841 tablet once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days) followed by washout period of at least 7 days followed by placebo matched to PF-06700841 tablet twice daily from Day 1 to Day 10 in the treatment period 3 for MAD cohort (28 days).
45582|NCT02310750|P6|Participant Flow|PF-­06700841: 200 mg SAD Cohort, 175 mg MAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 175 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
45583|NCT02310750|P5|Participant Flow|PF­-06700841: 100 mg SAD, 100 mg MAD, 50 mg MAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 100 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days) followed by washout period of at least 7 days, then PF-06700841 tablet 50 mg orally, twice daily from Day 1 to Day 10 in the treatment period 3 for MAD cohort (28 days).
45584|NCT02310750|P4|Participant Flow|PF-06700841: 30 mg SAD Cohort Then MAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 30 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
45585|NCT02310750|P3|Participant Flow|PF­-06700841: 10 mg SAD Cohort Then MAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 10 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
45947|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45589|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45590|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45591|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45592|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45593|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45594|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45595|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45596|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45597|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
45598|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45599|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45600|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45601|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45602|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45603|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45604|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45605|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45606|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45607|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45608|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45609|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45610|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45611|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45612|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45613|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45614|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
45615|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45616|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45617|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45618|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45619|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45620|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45621|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45622|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45623|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45624|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45625|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45626|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45627|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45628|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45629|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45630|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45631|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
45632|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45633|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45634|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45635|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45636|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45637|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45638|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45639|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45640|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45641|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45642|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45643|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45644|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45645|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45646|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45647|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45648|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
45649|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45650|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45651|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45652|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45653|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45654|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45657|NCT02310750|O4|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45658|NCT02310750|O3|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45659|NCT02310750|O2|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45660|NCT02310750|O1|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45661|NCT02310750|O5|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45662|NCT02310750|O4|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45663|NCT02310750|O3|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45664|NCT02310750|O2|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45665|NCT02310750|O1|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45666|NCT02310750|O5|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45667|NCT02310750|O4|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45668|NCT02310750|O3|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45669|NCT02310750|O2|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45670|NCT02310750|O1|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45671|NCT02310750|O7|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45672|NCT02310750|O6|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45673|NCT02310750|O5|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45674|NCT02310750|O4|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45675|NCT02310750|O3|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45676|NCT02310750|O2|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45677|NCT02310750|O1|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45678|NCT02310750|O13|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45679|NCT02310750|O12|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45680|NCT02310750|O11|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45681|NCT02310750|O10|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45682|NCT02310750|O9|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45683|NCT02310750|O8|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45684|NCT02310750|O7|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45685|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45686|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45687|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45688|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45690|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45691|NCT02310750|O13|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45692|NCT02310750|O12|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45693|NCT02310750|O11|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45694|NCT02310750|O10|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45695|NCT02310750|O9|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45696|NCT02310750|O8|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45697|NCT02310750|O7|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45698|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45699|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45700|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45701|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45702|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45703|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45704|NCT02310750|O13|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45705|NCT02310750|O12|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45706|NCT02310750|O11|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45707|NCT02310750|O10|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45708|NCT02310750|O9|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45709|NCT02310750|O8|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45710|NCT02310750|O7|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45711|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45712|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45713|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45714|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45715|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45716|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45717|NCT02310750|O16|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
45718|NCT02310750|O15|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
45719|NCT02310750|O14|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
45720|NCT02310750|O13|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45721|NCT02310750|O12|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
48057|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
45722|NCT02310750|O11|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45723|NCT02310750|O10|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45724|NCT02310750|O9|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45725|NCT02310750|O8|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45726|NCT02310750|O7|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45727|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45728|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45729|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45730|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45731|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45732|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45733|NCT02310750|O5|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45734|NCT02310750|O4|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45735|NCT02310750|O3|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45736|NCT02310750|O2|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45737|NCT02310750|O1|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45738|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45739|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45740|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45741|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45742|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45743|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45744|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45745|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45746|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45747|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45748|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45749|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45750|NCT02310750|O13|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45751|NCT02310750|O12|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45752|NCT02310750|O11|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45753|NCT02310750|O10|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45754|NCT02310750|O9|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
48058|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
45755|NCT02310750|O8|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45756|NCT02310750|O7|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45757|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45758|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45759|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45760|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45761|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45762|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45763|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45764|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45765|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45766|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45767|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45768|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45769|NCT02310750|O7|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45770|NCT02310750|O6|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45771|NCT02310750|O5|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45772|NCT02310750|O4|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45773|NCT02310750|O3|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45774|NCT02310750|O2|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45775|NCT02310750|O1|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45776|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45777|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45778|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45779|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45780|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45781|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45782|NCT02310750|O3|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
45783|NCT02310750|O2|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
45784|NCT02310750|O1|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
45785|NCT02310750|O13|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45786|NCT02310750|O12|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45787|NCT02310750|O11|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45788|NCT02310750|O10|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45789|NCT02310750|O9|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45790|NCT02310750|O8|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45791|NCT02310750|O7|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45792|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45793|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45794|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45795|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45796|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45797|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45798|NCT02310750|O13|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45799|NCT02310750|O12|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45800|NCT02310750|O11|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45801|NCT02310750|O10|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45802|NCT02310750|O9|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45803|NCT02310750|O8|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45804|NCT02310750|O7|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45805|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45806|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45807|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45808|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45809|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45810|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45811|NCT02310750|O3|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
45812|NCT02310750|O2|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
45813|NCT02310750|O1|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
45814|NCT02310750|O3|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
45815|NCT02310750|O2|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
45816|NCT02310750|O1|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
45817|NCT02310750|O3|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
45818|NCT02310750|O2|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
45819|NCT02310750|O1|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
45820|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45821|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45822|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45823|NCT02310750|O10|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45824|NCT02310750|O9|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45825|NCT02310750|O8|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45826|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45827|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45828|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45829|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45830|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45831|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45832|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
45833|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45834|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45835|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45836|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45837|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45838|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45839|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45840|NCT02310750|O20|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
45841|NCT02310750|O19|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
45842|NCT02310750|O18|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
45843|NCT02310750|O17|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45844|NCT02310750|O16|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45845|NCT02310750|O15|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45846|NCT02310750|O14|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45847|NCT02310750|O13|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45848|NCT02310750|O12|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45849|NCT02310750|O11|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45850|NCT02310750|O10|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45948|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45851|NCT02310750|O9|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45852|NCT02310750|O8|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
45853|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45854|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45855|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45856|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45857|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45858|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45859|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45860|NCT02310750|O20|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
45861|NCT02310750|O19|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
45862|NCT02310750|O18|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
45863|NCT02310750|O17|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45864|NCT02310750|O16|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45865|NCT02310750|O15|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45866|NCT02310750|O14|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45867|NCT02310750|O13|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45868|NCT02310750|O12|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45869|NCT02310750|O11|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45870|NCT02310750|O10|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45871|NCT02310750|O9|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45872|NCT02310750|O8|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
45873|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45874|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45875|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45876|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45877|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45878|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45879|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45880|NCT02310750|O20|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
45881|NCT02310750|O19|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
45882|NCT02310750|O18|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
46207|NCT02309723|E1|Reported Event|Positive Beta Amyloid Findings|"Beta amyloid imaging results indicated a positive finding.~Beta amyloid imaging"
45883|NCT02310750|O17|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45884|NCT02310750|O16|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45885|NCT02310750|O15|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45886|NCT02310750|O14|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45887|NCT02310750|O13|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45888|NCT02310750|O12|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45889|NCT02310750|O11|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45890|NCT02310750|O10|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45891|NCT02310750|O9|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45892|NCT02310750|O8|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
45893|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45894|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45895|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45896|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45897|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45898|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45899|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45900|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45901|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45902|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45903|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45904|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45905|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45906|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45907|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45908|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45909|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
45910|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45911|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45912|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45913|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45914|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45949|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45915|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45916|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45917|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45918|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45919|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45920|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45921|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45922|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45923|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45924|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45925|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45926|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
45927|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45928|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45929|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45930|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45931|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45932|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45933|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45934|NCT02310750|O20|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
45935|NCT02310750|O19|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
45936|NCT02310750|O18|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
45937|NCT02310750|O17|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45938|NCT02310750|O16|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45939|NCT02310750|O15|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45940|NCT02310750|O14|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45941|NCT02310750|O13|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45942|NCT02310750|O12|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45943|NCT02310750|O11|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45944|NCT02310750|O10|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45945|NCT02310750|O9|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45946|NCT02310750|O8|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
45951|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45952|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45953|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45954|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45955|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45956|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45957|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45958|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45959|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45960|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45961|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45962|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45963|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
45964|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45965|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45966|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45967|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45968|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45969|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45970|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45971|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45972|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45973|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45974|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45975|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45976|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45977|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45978|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45979|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45980|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
45981|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45982|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45983|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45984|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45985|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45986|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45987|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45988|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45989|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45990|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
45991|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45992|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45993|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45994|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45995|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
45996|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
45997|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
45998|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
45999|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
46000|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
46001|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
46002|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
46003|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
46004|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
46005|NCT02310750|E20|Reported Event|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
46006|NCT02310750|E19|Reported Event|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
46007|NCT02310750|E18|Reported Event|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
46008|NCT02310750|E17|Reported Event|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
46009|NCT02310750|E16|Reported Event|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
46010|NCT02310750|E15|Reported Event|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
46011|NCT02310750|E14|Reported Event|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
46012|NCT02310750|E13|Reported Event|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
46013|NCT02310750|E12|Reported Event|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
46014|NCT02310750|E11|Reported Event|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
46015|NCT02310750|E10|Reported Event|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
67823|NCT02153398|B6|Baseline|Total|Total of all reporting groups
46016|NCT02310750|E9|Reported Event|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
46017|NCT02310750|E8|Reported Event|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
46018|NCT02310750|E7|Reported Event|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
46019|NCT02310750|E6|Reported Event|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
46020|NCT02310750|E5|Reported Event|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
46021|NCT02310750|E4|Reported Event|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
46022|NCT02310750|E3|Reported Event|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
46023|NCT02310750|E2|Reported Event|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
46024|NCT02310750|E1|Reported Event|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
46025|NCT02310646|B3|Baseline|Total|Total of all reporting groups
46026|NCT02310646|B2|Baseline|Gel - Foam|Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam
46027|NCT02310646|B1|Baseline|Foam - Gel|Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel
46028|NCT02310646|P2|Participant Flow|Gel - Foam|"Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam~LEO 90100 Aerosol Foam: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week~Daivobet® gel: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week."
46029|NCT02310646|P1|Participant Flow|Foam - Gel|"Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel~LEO 90100 Aerosol Foam: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week~Daivobet® gel: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week."
46030|NCT02310646|O8|Outcome|Prefer Gel - Not at All Important Factor|Subjects who prefer gel
46031|NCT02310646|O7|Outcome|Prefer Gel - Not Very Important Factor|Subjects who prefer gel
46032|NCT02310646|O6|Outcome|Prefer Gel - Fairly Important Factor|Subjects who prefer gel
46033|NCT02310646|O5|Outcome|Prefer Gel - Very Important Factor|Subjects who prefer gel
46034|NCT02310646|O4|Outcome|Prefer Foam - Not at All Important Factor|Subjects who prefer foam
46035|NCT02310646|O3|Outcome|Prefer Foam - Not Very Important Factor|Subjects who prefer foam
46036|NCT02310646|O2|Outcome|Prefer Foam - Fairly Important Factor|Subjects who prefer foam
46037|NCT02310646|O1|Outcome|Prefer Foam - Very Important Factor|Subjects who prefer foam
46038|NCT02310646|O2|Outcome|Daivobet® Gel|Subject assessments of Daivobet® gel. This column shows Daivobet® gel assessments from the foam-gel group as well as the gel-foam group.
46039|NCT02310646|O1|Outcome|LEO 90100 Areosol Foam|Subject assessments of LEO 90100 aerosol foam. This column shows LEO 90100 foam assessments from the foam-gel group as well as the gel-foam group.
46040|NCT02310646|O2|Outcome|All Subjects Gel|Subject assessments of Daivobet® gel compared to latest topical treatment (CLTT analysis set).
46041|NCT02310646|O1|Outcome|All Subjects Foam|Subject assessments of LEO 90100 aerosol foam compared to latest topical treatment (CLTT analysis set).
46042|NCT02310646|O3|Outcome|Daivobet® Gel|"Subjects who had used topical treatment to treat their psoriasis within 3 months prior to baseline.~Subject assessments of Daivobet® gel. This column shows Daivobet® gel assessments from the foam-gel group as well as the gel-foam group."
46043|NCT02310646|O2|Outcome|LEO 90100 Aerosol Foam|"Subjects who had used topical treatment to treat their psoriasis within 3 months prior to Baseline.~Subject assessments of LEO 90100 aerosol foam. This column shows LEO 90100 aerosol foam assessments from the foam-gel group as well as the gel-foam group."
46044|NCT02310646|O1|Outcome|Latest Topical Treatment|Subjects who had used topical treatment to treat their psoriasis within 3 months prior to baseline. Assessments of last topical treatment (TPUQ tool) at baseline.
46045|NCT02310646|O2|Outcome|Daivobet® Gel|Subject assessments of Daivobet® gel. This column shows Daivobet® gel assessments from the foam-gel group as well as the gel-foam group.
46046|NCT02310646|O1|Outcome|LEO 90100 Areosol Foam|Subject assessments of LEO 90100 aerosol foam. This column shows LEO 90100 foam assessments from the foam-gel group as well as the gel-foam group.
46047|NCT02310646|O3|Outcome|Gel - Foam|Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam
46048|NCT02310646|O2|Outcome|Foam - Gel|Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel
46049|NCT02310646|O1|Outcome|All Randomised Subjects|All randomised subjects (foam – gel and gel – foam)
46050|NCT02310646|E2|Reported Event|Gel - Foam|"Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam~LEO 90100 Aerosol Foam: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week~Daivobet® gel: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week."
46051|NCT02310646|E1|Reported Event|Foam - Gel|"Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel~LEO 90100 Aerosol Foam: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week~Daivobet® gel: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week."
46052|NCT02310581|B5|Baseline|Total|Total of all reporting groups
68136|NCT02151994|O3|Outcome|25 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
46054|NCT02310581|B3|Baseline|Buprenorphine 1.0 mg TID|Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
46055|NCT02310581|B2|Baseline|Buprenorphine 1.0 mg BID|Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
46056|NCT02310581|B1|Baseline|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
46057|NCT02310581|P4|Participant Flow|Placebo|Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
46058|NCT02310581|P3|Participant Flow|Buprenorphine 1.0 mg TID|Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
46059|NCT02310581|P2|Participant Flow|Buprenorphine 1.0 mg BID|Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
46060|NCT02310581|P1|Participant Flow|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual (under the tongue) spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
46061|NCT02310581|O4|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
46062|NCT02310581|O3|Outcome|Buprenorphine 1.0 mg TID|Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
46063|NCT02310581|O2|Outcome|Buprenorphine 1.0 mg BID|Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
46064|NCT02310581|O1|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
46065|NCT02310581|O4|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
46066|NCT02310581|O3|Outcome|Buprenorphine 1.0 mg TID|Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
46067|NCT02310581|O2|Outcome|Buprenorphine 1.0 mg BID|Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
46068|NCT02310581|O1|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
46069|NCT02310581|O4|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
46070|NCT02310581|O3|Outcome|Buprenorphine 1.0 mg TID|Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
46071|NCT02310581|O2|Outcome|Buprenorphine 1.0 mg BID|Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
46072|NCT02310581|O1|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
46073|NCT02310581|O4|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
46074|NCT02310581|O3|Outcome|Buprenorphine 1.0 mg TID|Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
46075|NCT02310581|O2|Outcome|Buprenorphine 1.0 mg BID|Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
46076|NCT02310581|O1|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
46077|NCT02310581|O4|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
46078|NCT02310581|O3|Outcome|Buprenorphine 1.0 mg TID|Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
46079|NCT02310581|O2|Outcome|Buprenorphine 1.0 mg BID|Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
46080|NCT02310581|O1|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
46081|NCT02310581|O4|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
46082|NCT02310581|O3|Outcome|Buprenorphine 1.0 mg TID|Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
46083|NCT02310581|O2|Outcome|Buprenorphine 1.0 mg BID|Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
46084|NCT02310581|O1|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
46085|NCT02310581|O4|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
46086|NCT02310581|O3|Outcome|Buprenorphine 1.0 mg TID|Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
46087|NCT02310581|O2|Outcome|Buprenorphine 1.0 mg BID|Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
46088|NCT02310581|O1|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
46089|NCT02310581|E4|Reported Event|Placebo|Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
46090|NCT02310581|E3|Reported Event|Buprenorphine 1.0 mg TID|Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
46091|NCT02310581|E2|Reported Event|Buprenorphine 1.0 mg BID|Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
46092|NCT02310581|E1|Reported Event|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
46093|NCT02310568|B6|Baseline|Total|Total of all reporting groups
46094|NCT02310568|B5|Baseline|PF-06372865 7.5 mg + Placebo|Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
46095|NCT02310568|B4|Baseline|PF-06372865 2.5 mg + Placebo|Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
46096|NCT02310568|B3|Baseline|Placebo + PF-06372865 7.5 mg|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then single oral dose of PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 2.
46097|NCT02310568|B2|Baseline|Placebo + PF-06372865 2.5 mg|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by a single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 2.
46098|NCT02310568|B1|Baseline|Placebo + Placebo|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
46099|NCT02310568|P5|Participant Flow|PF-06372865 7.5 mg + Placebo|Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
46100|NCT02310568|P4|Participant Flow|PF-06372865 2.5 mg + Placebo|Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
46101|NCT02310568|P3|Participant Flow|Placebo + PF-06372865 7.5 mg|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then single oral dose of PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 2.
46102|NCT02310568|P2|Participant Flow|Placebo + PF-06372865 2.5 mg|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by a single oral dose of PF-06372865 2.5 milligram (mg) tablet twice daily for 4 weeks during Stage 2.
46103|NCT02310568|P1|Participant Flow|Placebo + Placebo|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
46104|NCT02310568|O6|Outcome|PF­06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
46105|NCT02310568|O5|Outcome|PF­06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
46106|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
46107|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
46108|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
46109|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
46110|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
46111|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
46112|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
46113|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
46114|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
46115|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
46116|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
46117|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
46118|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
46119|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
46120|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
46121|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
46122|NCT02310568|O2|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
46123|NCT02310568|O1|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
46124|NCT02310568|O2|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
46125|NCT02310568|O1|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
46126|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
46127|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
46128|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
46129|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
46130|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
46131|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
46132|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
46133|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
46134|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
46135|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
46136|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
46137|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
46138|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
46139|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
46140|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
46141|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
46142|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
46143|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
46144|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
46145|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
46146|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
46147|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
46148|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
46149|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
46150|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
46151|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
46152|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
46153|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
46154|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
46155|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
46156|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
46157|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
46158|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
46159|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
46160|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
46161|NCT02310568|O1|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
46162|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
68137|NCT02151994|O2|Outcome|5 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
46163|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
46164|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
46165|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
46166|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
46167|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
46168|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
46169|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
46170|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
46171|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
46172|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
46173|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
46174|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
46175|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
46176|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
46177|NCT02310568|E3|Reported Event|PF-06372865 7.5 mg|All participants received PF-06372865 7.5 mg twice daily for 4 weeks in Stage 1 and Stage 2.
46178|NCT02310568|E2|Reported Event|PF-06372865 2.5 mg|All participants received PF-06372865 2.5 mg twice daily for 4 weeks in Stage 1 and Stage 2.
46179|NCT02310568|E1|Reported Event|Placebo|All participants received placebo matched to PF-06372865 twice daily for 4 weeks in Stage 1 and Stage 2.
46180|NCT02310126|B3|Baseline|Total|Total of all reporting groups
46181|NCT02310126|B2|Baseline|Etafilcon A(Sphere) / Etafilcon A(Multi-focal)|Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A(sphere) contact lens and then received the etafilcon A(multi-focal) contact lens.
46182|NCT02310126|B1|Baseline|Etafilcon A(Multi-focal)/ Etafilcon A(Sphere)|Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A(multi-focal) contact lens and then received the etafilcon A(sphere) contact lens.
46183|NCT02310126|P2|Participant Flow|Etafilcon A(Sphere)/Etafilcon A(Multi-focal)|Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A (sphere) contact lens and then received the etafilcon A(multi-focal) contact lens.
46184|NCT02310126|P1|Participant Flow|Etafilcon A(Multi-focal)/Etafilcon A(Sphere)|Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A (sphere) contact lens and then received the etafilcon A (multi-focal) contact lens.
46185|NCT02310126|O2|Outcome|Etafilcon A (Sphere)|Subjects that received the etafilcon A (sphere) contact lens during either the first or second period of the study.
46186|NCT02310126|O1|Outcome|Etafilcon A(Multi-focal)|Subjects that received the etafilcon A (multi-focal) contact lens during either the first or second period of the study.
46187|NCT02310126|E2|Reported Event|Etafilcon A (Sphere)|Subjects that received the etafilcon A (sphere) contact lens during either the first or second period of the study.
46188|NCT02310126|E1|Reported Event|Etafilcon A (Multi-focal)|Subjects that received the etafilcon A (multi-focal) contact lens during either the first or second period of the study.
46189|NCT02309723|B4|Baseline|Total|Total of all reporting groups
46190|NCT02309723|B3|Baseline|No Beta Amyloid Information|Survey respondents presented scenario with no beta amyloid information.
46191|NCT02309723|B2|Baseline|Negative Beta Amyloid Findings|Survey respondents presented scenario in which beta amyloid imaging results indicated a negative finding.
46192|NCT02309723|B1|Baseline|Positive Beta Amyloid Findings|Survey respondents presented scenario in which beta amyloid imaging results indicated a positive finding.
46193|NCT02309723|P3|Participant Flow|No Beta Amyloid Information|
46194|NCT02309723|P2|Participant Flow|Negative Beta Amyloid Findings|"Beta amyloid imaging results indicated a negative finding.~Beta amyloid imaging"
46195|NCT02309723|P1|Participant Flow|Positive Beta Amyloid Findings|"Beta amyloid imaging results indicated a positive finding.~Beta amyloid imaging"
46196|NCT02309723|O3|Outcome|No Beta Amyloid Information|
46197|NCT02309723|O2|Outcome|Negative Beta Amyloid Findings|"Beta amyloid imaging results indicated a negative finding.~Beta amyloid imaging"
46198|NCT02309723|O1|Outcome|Positive Beta Amyloid Findings|"Beta amyloid imaging results indicated a positive finding.~Beta amyloid imaging"
46199|NCT02309723|O3|Outcome|No Beta Amyloid Information|
46200|NCT02309723|O2|Outcome|Negative Beta Amyloid Findings|"Beta amyloid imaging results indicated a negative finding.~Beta amyloid imaging"
46201|NCT02309723|O1|Outcome|Positive Beta Amyloid Findings|"Beta amyloid imaging results indicated a positive finding.~Beta amyloid imaging"
46202|NCT02309723|O3|Outcome|No Beta Amyloid Information|
46203|NCT02309723|O2|Outcome|Negative Beta Amyloid Findings|"Beta amyloid imaging results indicated a negative finding.~Beta amyloid imaging"
46204|NCT02309723|O1|Outcome|Positive Beta Amyloid Findings|"Beta amyloid imaging results indicated a positive finding.~Beta amyloid imaging"
46205|NCT02309723|E3|Reported Event|No Beta Amyloid Information|
46208|NCT02309294|B1|Baseline|Healthy Subject|Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).
46209|NCT02309294|P1|Participant Flow|Healthy Subject|Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).
46210|NCT02309294|O1|Outcome|Healthy Subject|Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).
46211|NCT02309294|E1|Reported Event|Healthy Subject|Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).
46212|NCT02309112|B4|Baseline|Total|Total of all reporting groups
46213|NCT02309112|B3|Baseline|Yoga Group C: Maximum Exposure|"The maximum-dose yoga package, this intervention includes the components of Group A, with the same 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. As in Group B, a pre-paid online yoga membership to http://www.myyogaonline.com was also provided for the duration of the study. Participants were then invited to attend three 60-minute yoga group classes led by an expert yoga instructor per week (weeks 1 to 4). These yoga sessions were held in a clinical setting in proximity to their treatment location and delivered at no cost to the patient.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
46214|NCT02309112|B2|Baseline|Yoga Group B: Medium Exposure|"The medium-exposure yoga package, this intervention includes the components of Group A, with an additional 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. A pre-paid online yoga membership to http://www.myyogaonline.com was offered for the duration of the study. In addition to this, one 120-minute workshop to further develop yoga pranayama, dhyana and asana training was administered by an expert instructor during week 2 or 3.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
46215|NCT02309112|B1|Baseline|Yoga Group A: Minimum Exposure|"The minimum-exposure yoga package, this intervention included 45-minutes of contact time with a trained yoga professional. This session included a 30-minute introductory session focussing on pranayama (breathing techniques), as well as a brief introduction to available community-based and online yoga to encourage a safe home-based practice (15-minutes). Financial subsidy, compensation or special promotion of any particular yoga was not provided. Participants were invited to stay for a social discussion following the yoga class.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
46216|NCT02309112|P3|Participant Flow|Yoga Group C|"The maximum-dose yoga package, this intervention includes the components of Group A, with the same 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. As in Group B, a pre-paid online yoga membership to http://www.myyogaonline.com was also provided for the duration of the study. Participants were then invited to attend three 60-minute yoga group classes led by an expert yoga instructor per week (weeks 1 to 4). These yoga sessions were held in a clinical setting in proximity to their treatment location and delivered at no cost to the patient.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
46217|NCT02309112|P2|Participant Flow|Yoga Group B|"The medium-exposure yoga package, this intervention includes the components of Group A, with an additional 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. A pre-paid online yoga membership to http://www.myyogaonline.com was offered for the duration of the study. In addition to this, one 120-minute workshop to further develop yoga pranayama, dhyana and asana training was administered by an expert instructor during week 2 or 3.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
46218|NCT02309112|P1|Participant Flow|Yoga Group A|"The minimum-exposure yoga package, this intervention included 45-minutes of contact time with a trained yoga professional. This session included a 30-minute introductory session focussing on pranayama (breathing techniques), as well as a brief introduction to available community-based and online yoga to encourage a safe home-based practice (15-minutes). Financial subsidy, compensation or special promotion of any particular yoga was not provided. Participants were invited to stay for a social discussion following the yoga class.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
46219|NCT02309112|O3|Outcome|Yoga Group C: Maximum Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)
46220|NCT02309112|O2|Outcome|Yoga Group B: Medium Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
46221|NCT02309112|O1|Outcome|Yoga Group A: Minimum Exposure|Week 1: 1 x 45-minute introductory yoga session (breathing techniques only); recommended community-based resources for in-person yoga and online yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat)
46222|NCT02309112|O3|Outcome|Yoga Group C: Maximum Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)
46242|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
46223|NCT02309112|O2|Outcome|Yoga Group B: Medium Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
46224|NCT02309112|O1|Outcome|Yoga Group A: Minimum Exposure|Week 1: 1 x 45-minute introductory yoga session (breathing techniques only); recommended community-based resources for in-person yoga and online yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat)
46225|NCT02309112|O3|Outcome|Yoga Group C: Maximum Exposure|"Maximum Yoga Dose~Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)"
46226|NCT02309112|O2|Outcome|Yoga Group B: Medium Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
46227|NCT02309112|O1|Outcome|Yoga Group A: Minimum Exposure|Week 1: 1 x 45-minute introductory yoga session (breathing techniques only); recommended community-based resources for in-person yoga and online yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat)
46228|NCT02309112|O3|Outcome|Yoga Group C: Maximum Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)
46229|NCT02309112|O2|Outcome|Yoga Group B: Medium Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
46230|NCT02309112|O1|Outcome|Yoga Group A: Minimum Exposure|Week 1: 1 x 45-minute introductory yoga session (breathing techniques only); recommended community-based resources for in-person yoga and online yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat)
46231|NCT02309112|O3|Outcome|Yoga Group C: Maximum Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)
46232|NCT02309112|O2|Outcome|Yoga Group B: Medium Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
46233|NCT02309112|O1|Outcome|Yoga Group A: Minimum Exposure|Week 1: 1 x 45-minute introductory yoga session (breathing techniques only); recommended community-based resources for in-person yoga and online yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat)
46234|NCT02309112|O1|Outcome|Eligible Participants|The group of eligible participants who agreed to be randomized to ono of three yoga groups.
46235|NCT02309112|E3|Reported Event|Yoga Group C|"The maximum-dose yoga package, this intervention includes the components of Group A, with the same 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. As in Group B, a pre-paid online yoga membership to http://www.myyogaonline.com was also provided for the duration of the study. Participants were then invited to attend three 60-minute yoga group classes led by an expert yoga instructor per week (weeks 1 to 4). These yoga sessions were held in a clinical setting in proximity to their treatment location and delivered at no cost to the patient.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
46236|NCT02309112|E2|Reported Event|Yoga Group B|"The medium-exposure yoga package, this intervention includes the components of Group A, with an additional 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. A pre-paid online yoga membership to http://www.myyogaonline.com was offered for the duration of the study. In addition to this, one 120-minute workshop to further develop yoga pranayama, dhyana and asana training was administered by an expert instructor during week 2 or 3.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
46237|NCT02309112|E1|Reported Event|Yoga Group A|"The minimum-exposure yoga package, this intervention included 45-minutes of contact time with a trained yoga professional. This session included a 30-minute introductory session focussing on pranayama (breathing techniques), as well as a brief introduction to available community-based and online yoga to encourage a safe home-based practice (15-minutes). Financial subsidy, compensation or special promotion of any particular yoga was not provided. Participants were invited to stay for a social discussion following the yoga class.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
46238|NCT02308787|B1|Baseline|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
46239|NCT02308787|P1|Participant Flow|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
46240|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
46241|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
46243|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
46244|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
46245|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
46246|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
46247|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
46248|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
46249|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
46250|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
46251|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
46252|NCT02308787|E1|Reported Event|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
46253|NCT02308748|B1|Baseline|All Study Participants|Participants who were randomized to receive either dofetilide alone, dofetilide + mexiletine, dofetilide + lidocaine, moxifloxacin + diltiazem or placebo.
46254|NCT02308748|P10|Participant Flow|C-B-D-E-A|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment C (dofetilide + mexiletine) Treatment B (dofetilide + lidocaine) Treatment D (moxifloxacin + diltiazem) Treatment E (placebo) Treatment A (dofetilide)"
46255|NCT02308748|P9|Participant Flow|B-E-C-A-D|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment B (dofetilide + lidocaine) Treatment E (placebo) Treatment C (dofetilide + mexiletine) Treatment A (dofetilide) Treatment D (moxifloxacin + diltiazem)"
46256|NCT02308748|P8|Participant Flow|A-E-D-B-C|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment A (dofetilide) Treatment E (placebo) Treatment D (moxifloxacin + diltiazem) Treatment B (dofetilide + lidocaine) Treatment C (dofetilide + mexiletine)"
46257|NCT02308748|P7|Participant Flow|E-B-A-C-D|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment E (placebo) Treatment B (dofetilide + lidocaine) Treatment A (dofetilide) Treatment C (dofetilide + mexiletine) Treatment D (moxifloxacin + diltiazem)"
46258|NCT02308748|P6|Participant Flow|D-A-C-E-B|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment D (moxifloxacin + diltiazem) Treatment A (dofetilide) Treatment C (dofetilide + mexiletine) Treatment E (placebo) Treatment B (dofetilide + lidocaine)"
46259|NCT02308748|P5|Participant Flow|E-A-B-D-C|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment E (placebo) Treatment A (dofetilide) Treatment B (dofetilide + lidocaine) Treatment D (moxifloxacin + diltiazem) Treatment C (dofetilide + mexiletine)"
46260|NCT02308748|P4|Participant Flow|D-C-A-B-E|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment D (moxifloxacin + diltiazem) Treatment C (dofetilide + mexiletine) Treatment A (dofetilide) Treatment B (dofetilide + lidocaine) Treatment E (placebo)"
46261|NCT02308748|P3|Participant Flow|C-D-B-A-E|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment C (dofetilide + mexiletine) Treatment D (moxifloxacin + diltiazem) Treatment B (dofetilide + lidocaine) Treatment A (dofetilide) Treatment E (placebo)"
46262|NCT02308748|P2|Participant Flow|B-C-E-D-A|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment B (dofetilide + lidocaine) Treatment C (dofetilide + mexiletine) Treatment E (placebo) Treatment D (moxifloxacin + diltiazem) Treatment A (dofetilide)"
46263|NCT02308748|P1|Participant Flow|A-D-E-C-B|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment A (dofetilide) Treatment D (moxifloxacin + diltiazem) Treatment E (placebo) Treatment C (dofetilide + mexiletine) Treatment B (dofetilide + lidocaine)"
46264|NCT02308748|O2|Outcome|Moxifloxacin + Diltiazem|Subjects that completed placebo and moxifloxacin + diltiazem interventions
46265|NCT02308748|O1|Outcome|Moxifloxacin Alone|Subjects that completed placebo and moxifloxacin alone interventions
46266|NCT02308748|O3|Outcome|Dofetilide + Lidocaine|Subjects that completed placebo and dofetilide + lidocaine interventions
46267|NCT02308748|O2|Outcome|Dofetilide + Mexiletine|Subjects that completed placebo and dofetilide + mexiletine interventions
46268|NCT02308748|O1|Outcome|Dofetilide Alone|Subjects that completed placebo and dofetilide alone interventions
46270|NCT02308748|E4|Reported Event|Moxifloxacin + Diltiazem|"Moxifloxacin with and without diltiazem.~Moxifloxacin: • 9 am: 5.63 mg/h per kg (loading) for 1 hour and 0.26 mg/h per kg (maintenance for 30 minutes)~2 pm: 6.14 mg/h per kg (loading) for 1 hour and 0.49 mg/h per kg (maintenance for 30 minutes)~7:30 pm: 2.23 mg/h per kg (loading) for 1 hour and 0.49 mg/h per kg (maintenance for 30 minutes)~Diltiazem: • 7:30 pm: 330 µg/h per kg (loading) for 60 minutes and 61 µg/h per kg (maintenance) for 30 minutes"
46271|NCT02308748|E3|Reported Event|Dofetilide + Mexiletine|"Dofetilide combined with mexiletine~Dofetilide: • 8 am: Placebo~12 pm (noon): 250 µg~5:30 pm: 250 µg~Mexiletine: • 8 am: weight x 4 mg/kg~12 pm (noon): Same as at 8 am~5:30 pm: Same as at 8 am"
46272|NCT02308748|E2|Reported Event|Dofetilide + Lidocaine|"Dofetilide combined with lidocaine~Dofetilide: • 8 am: Placebo~12 pm (noon): 250 µg~5:30 pm: 250 µg~Lidocaine: • 9 am : 30 µg/min per kg (loading) for 60 minutes and 10 µg/min per kg (maintenance) for 30 minutes~2 pm: 55 µg/min per kg (loading) for 60 minutes and 20 µg/min per kg (maintenance) for 30 minutes~7:30 pm: 52 µg/min per kg (loading) for 60 minutes and 20 µg/min per kg (maintenance) for 30 minutes"
46273|NCT02308748|E1|Reported Event|Dofetilide|"Dofetilide alone arm~Dofetilide: • 8 am: Placebo~12 pm (noon): 250 µg~5:30 pm: 250 µg"
46274|NCT02308371|B3|Baseline|Total|Total of all reporting groups
46275|NCT02308371|B2|Baseline|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data. PPV was not used to guide therapy in this group of patients.
46276|NCT02308371|B1|Baseline|Prospective|"Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output) in addition to information provided by automated pulse pressure variation (PPV). PPV will be followed for first 48 hours after recruitment to the study. Fluid (normal saline, albumin 5%, hetastarch per the clinician preference) will be given in 5cc/kg increments for PPV> 13 (in addition to standard clinical data) until PPV < 13.~Automated Pulse Pressure Variation: Based on standard of care, the physician will give fluid as needed based on standard clinical data (heart rate, central venous pressure if available, blood pressure, urine output, physical exam, lactate level) and pulse pressure variation. PPV should be elevated consistently greater than 15 minutes before giving fluid without other symptoms of patient instability (low blood pressure, elevated lactate, tachycardia). Pulse pressure variation will be followed for 48 hours."
46277|NCT02308371|P2|Participant Flow|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
46278|NCT02308371|P1|Participant Flow|Prospective|"Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV). PPV will be followed for first 48 hours after recruitment to the study. Fluid (normal saline, albumin 5%, hetastarch per the clinician preference) will be given in 5ml/kg increments for PPV> 13.~Automated Pulse Pressure Variation: Based on standard of care, the physician will give fluid as needed based on standard clinical data (heart rate, central venous pressure if available, blood pressure, urine output, physical exam, lactate level) and pulse pressure variation. PPV should be elevated consistently greater than 15 minutes before giving fluid without other symptoms of patient instability (low blood pressure, elevated lactate, tachycardia). Pulse pressure variation will be followed for 48 hours."
46279|NCT02308371|O2|Outcome|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
46280|NCT02308371|O1|Outcome|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).
46281|NCT02308371|O2|Outcome|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
46282|NCT02308371|O1|Outcome|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).
46283|NCT02308371|O2|Outcome|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
46284|NCT02308371|O1|Outcome|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).
46285|NCT02308371|O2|Outcome|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data. PPV was not used to guide therapy in this group of patients.
46286|NCT02308371|O1|Outcome|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output) in addition to information provided by automated pulse pressure variation (PPV). PPV will be followed for first 48 hours after recruitment to the study. Fluid (normal saline, albumin 5%, hetastarch per the clinician preference) will be given in 5cc/kg increments for PPV> 13 (in addition to standard clinical data) until PPV < 13.
46287|NCT02308371|O2|Outcome|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
46288|NCT02308371|O1|Outcome|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).
46289|NCT02308371|E2|Reported Event|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
46338|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
68274|NCT02151461|O4|Outcome|Control|Day 1-14: 500mg, Day 15-28: 850mg
46290|NCT02308371|E1|Reported Event|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).
46291|NCT02308124|B4|Baseline|Total|Total of all reporting groups
46292|NCT02308124|B3|Baseline|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
46293|NCT02308124|B2|Baseline|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
46294|NCT02308124|B1|Baseline|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
46295|NCT02308124|P3|Participant Flow|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
46296|NCT02308124|P2|Participant Flow|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
46297|NCT02308124|P1|Participant Flow|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
46298|NCT02308124|O3|Outcome|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
46299|NCT02308124|O2|Outcome|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
46300|NCT02308124|O1|Outcome|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
46301|NCT02308124|O3|Outcome|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
46302|NCT02308124|O2|Outcome|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
46303|NCT02308124|O1|Outcome|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
46304|NCT02308124|O3|Outcome|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
46305|NCT02308124|O2|Outcome|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
46306|NCT02308124|O1|Outcome|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
46307|NCT02308124|O3|Outcome|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
46308|NCT02308124|O2|Outcome|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
46309|NCT02308124|O1|Outcome|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
46310|NCT02308124|O3|Outcome|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
46311|NCT02308124|O2|Outcome|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
46312|NCT02308124|O1|Outcome|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
46313|NCT02308124|E3|Reported Event|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
46314|NCT02308124|E2|Reported Event|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
46315|NCT02308124|E1|Reported Event|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
46316|NCT02307838|B4|Baseline|Total|Total of all reporting groups
46317|NCT02307838|B3|Baseline|Non-continuous: Other DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
46318|NCT02307838|B2|Baseline|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
46319|NCT02307838|B1|Baseline|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
46320|NCT02307838|P3|Participant Flow|Placebo|In FTY720D2201, participants received matching placebo to FTY720 q.d. for 6 months.
46321|NCT02307838|P2|Participant Flow|FTY720 1.25 mg|In FTY720D2201, participants received FTY720 1.25 mg q.d. oral dose for 6 months.
46322|NCT02307838|P1|Participant Flow|FTY720 5.0 mg|In FTY720D2201, participants received FTY720 5.0 mg every day (q.d.) oral dose for 6 months.
46323|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
46324|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
46325|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
46326|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
46327|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
46328|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
46329|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
46330|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
46331|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
46332|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
46333|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
46334|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
46339|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
46340|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
46341|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
46342|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
46343|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
46344|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
46345|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
46346|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
46347|NCT02307838|O3|Outcome|Non-continuous: Other DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
46348|NCT02307838|O2|Outcome|Non-continuous: High Efficacy DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high efficacy disease modifying therapies (DMTs) for at least 2 years.
46349|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
46350|NCT02307838|O3|Outcome|Non-continuous: Other DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
46351|NCT02307838|O2|Outcome|Non-continuous: High Efficacy DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high efficacy disease modifying therapies (DMTs) for at least 2 years.
46352|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
46353|NCT02307838|O3|Outcome|Non-continuous: Other DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
46354|NCT02307838|O2|Outcome|Non-continuous: High Efficacy DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high efficacy disease modifying therapies (DMTs) for at least 2 years.
46355|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
46356|NCT02307838|O3|Outcome|Non-continuous: Other DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
46357|NCT02307838|O2|Outcome|Non-continuous: High Efficacy DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high efficacy disease modifying therapies (DMTs) for at least 2 years.
46358|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
46359|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
46360|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
46361|NCT02307838|E3|Reported Event|Non-continuous: Other DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
46362|NCT02307838|E2|Reported Event|Non-continuous: High Efficacy DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy disease modifying therapies (DMTs) for at least 2 years.
46363|NCT02307838|E1|Reported Event|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
46364|NCT02307552|B1|Baseline|All Patients|"All patients in the study will receive a scan of their prostate with the novel UreScan machine. All scans will be evaluated in their accuracy of detecting cancer loci within the prostate as compared to histopathological reviews of the prostate post robotic prostatectomy.~UreScan: The TUUS Foley/catheter will be inserted into the urethra via the ultrasound visualization onto the apex prostate, and the ultrasound extended through the urethra until the bladder neck and stopped. This is recorded twice automatically, and this should take 5-10 minutes for completion, and the prostate ultrasound data stored in memory. The ultrasound/subject interaction is now complete, and the study should add 30-60 minutes to the preoperative visit. No local or general anesthesia is used. The subject will be given 500 mg of Ciprofloxacin as a preventative measure against a urinary tract infection."
46365|NCT02307552|P1|Participant Flow|All Patients|"All patients in the study will receive a scan of their prostate with the novel UreScan machine. All scans will be evaluated in their accuracy of detecting cancer loci within the prostate as compared to histopathological reviews of the prostate post robotic prostatectomy.~UreScan: The TUUS Foley/catheter will be inserted into the urethra via the ultrasound visualization onto the apex prostate, and the ultrasound extended through the urethra until the bladder neck and stopped. This is recorded twice automatically, and this should take 5-10 minutes for completion, and the prostate ultrasound data stored in memory. The ultrasound/subject interaction is now complete, and the study should add 30-60 minutes to the preoperative visit. No local or general anesthesia is used. The subject will be given 500 mg of Ciprofloxacin as a preventative measure against a urinary tract infection."
46388|NCT02307266|B1|Baseline|Standard of Care + Supplementary Education|Subjects received supplementary patient educational material in addition to standard-of-care instructions.
46389|NCT02307266|P3|Participant Flow|Standard of Care + Additional Visits|Subjects received standard-of-care instructions, and two additional clinical visits.
46390|NCT02307266|P2|Participant Flow|Standard of Care|Subjects received standard-of-care instructions only.
47664|NCT02294474|O2|Outcome|Humalog|Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
46366|NCT02307552|O1|Outcome|All Patients|"All patients in the study will receive a scan of their prostate with the novel UreScan machine. All scans will be evaluated in their accuracy of detecting cancer loci within the prostate as compared to histopathological reviews of the prostate post robotic prostatectomy.~UreScan: The TUUS Foley/catheter will be inserted into the urethra via the ultrasound visualization onto the apex prostate, and the ultrasound extended through the urethra until the bladder neck and stopped. This is recorded twice automatically, and this should take 5-10 minutes for completion, and the prostate ultrasound data stored in memory. The ultrasound/subject interaction is now complete, and the study should add 30-60 minutes to the preoperative visit. No local or general anesthesia is used. The subject will be given 500 mg of Ciprofloxacin as a preventative measure against a urinary tract infection."
46367|NCT02307552|E1|Reported Event|All Patients|"All patients in the study will receive a scan of their prostate with the novel UreScan machine. All scans will be evaluated in their accuracy of detecting cancer loci within the prostate as compared to histopathological reviews of the prostate post robotic prostatectomy.~UreScan: The TUUS Foley/catheter will be inserted into the urethra via the ultrasound visualization onto the apex prostate, and the ultrasound extended through the urethra until the bladder neck and stopped. This is recorded twice automatically, and this should take 5-10 minutes for completion, and the prostate ultrasound data stored in memory. The ultrasound/subject interaction is now complete, and the study should add 30-60 minutes to the preoperative visit. No local or general anesthesia is used. The subject will be given 500 mg of Ciprofloxacin as a preventative measure against a urinary tract infection."
46368|NCT02307526|B1|Baseline|Spinal Cord Injury|Ten individuals with SCI (C4-C7) were recruited.
46369|NCT02307526|P1|Participant Flow|Spinal Cord Injury|10 individuals with spinal cord injury (SCI: C4-C7) were recruited.
46370|NCT02307526|O2|Outcome|NO Drug|Following the 60 minute resting position, a progressive head-up tilt will be utilized in which the table will be adjusted to 15°, 25°, 35° for 5 minutes at each angle and then maintained at 45° for 45 minutes or until the subjects experiences symptoms of compromised cerebral blood flow, which include, but are not limited to, light headedness, blurry vision, dizziness and nausea.
46371|NCT02307526|O1|Outcome|Pyridostigmine Bromide|After being transferred onto a tilt table, subject will lie in a rested, supine position in which the study drug, pyridostigmine bromide will be administered at the 30 minute time point. Following the administration of the study drug, the subject will remain in the supine position for an additional 30 minutes until the tilting protocol commences.
46372|NCT02307526|O2|Outcome|NO Drug|Following the 60 minute resting position, a progressive head-up tilt will be utilized in which the table will be adjusted to 15°, 25°, 35° for 5 minutes at each angle and then maintained at 45° for 45 minutes or until the subjects experiences symptoms of compromised cerebral blood flow, which include, but are not limited to, light headedness, blurry vision, dizziness and nausea.
46373|NCT02307526|O1|Outcome|Pyridostigmine Bromide|After being transferred onto a tilt table, subject will lie in a rested, supine position in which the study drug, pyridostigmine bromide will be administered at the 30 minute time point. Following the administration of the study drug, the subject will remain in the supine position for an additional 30 minutes until the tilting protocol commences.
46374|NCT02307526|O2|Outcome|NO Drug|Following the 60 minute resting position, a progressive head-up tilt will be utilized in which the table will be adjusted to 15°, 25°, 35° for 5 minutes at each angle and then maintained at 45° for 45 minutes or until the subjects experiences symptoms of compromised cerebral blood flow, which include, but are not limited to, light headedness, blurry vision, dizziness and nausea.
46375|NCT02307526|O1|Outcome|Pyridostigmine Bromide|After being transferred onto a tilt table, subject will lie in a rested, supine position in which the study drug, pyridostigmine bromide will be administered at the 30 minute time point. Following the administration of the study drug, the subject will remain in the supine position for an additional 30 minutes until the tilting protocol commences.
46376|NCT02307526|E2|Reported Event|Day 2 - Pyridostigmine Bromide|After being transferred onto a tilt table, subject will lie in a rested, supine position in which the study drug, pyridostigmine bromide 60 mg will be administered at the 30 minute time point. Following the administration of the study drug, the subject will remain in the supine position for an additional 30 minutes until the tilting protocol commences.
46377|NCT02307526|E1|Reported Event|Day 1 - No Drug|Following the 60 minute resting position, a progressive head-up tilt will be utilized in which the table will be adjusted to 15°, 25°, 35° for 5 minutes at each angle and then maintained at 45° for 45 minutes or until the subjects experiences symptoms of compromised cerebral blood flow, which include, but are not limited to, light headedness, blurry vision, dizziness and nausea.
46378|NCT02307318|B1|Baseline|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
46379|NCT02307318|P1|Participant Flow|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
46380|NCT02307318|O1|Outcome|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
46381|NCT02307318|O1|Outcome|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
46382|NCT02307318|O1|Outcome|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
46383|NCT02307318|O1|Outcome|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
46384|NCT02307318|E1|Reported Event|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
46385|NCT02307266|B4|Baseline|Total|Total of all reporting groups
46386|NCT02307266|B3|Baseline|Standard of Care + Additional Visits|Subjects received standard-of-care instructions, and two additional clinical visits.
46387|NCT02307266|B2|Baseline|Standard of Care|Subjects received standard-of-care instructions only.
46391|NCT02307266|P1|Participant Flow|Standard of Care + Supplementary Education|Subjects received supplementary patient educational material in addition to standard-of-care instructions.
46392|NCT02307266|O3|Outcome|Standard of Care + Additional Visits|Subjects received standard-of-care instructions, and two additional clinical visits.
46393|NCT02307266|O2|Outcome|Standard of Care|Subjects received standard-of-care instructions only.
46394|NCT02307266|O1|Outcome|Standard of Care + Supplementary Education|Subjects received supplementary patient educational material in addition to standard-of-care instructions.
46395|NCT02307266|E3|Reported Event|Standard of Care + Additional Visits|Subjects received standard-of-care instructions, and two additional clinical visits.
46396|NCT02307266|E2|Reported Event|Standard of Care|Subjects received standard-of-care instructions only.
46397|NCT02307266|E1|Reported Event|Standard of Care + Supplementary Education|Subjects received supplementary patient educational material in addition to standard-of-care instructions.
46398|NCT02307188|B1|Baseline|Basket Catheter|"The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms.~Constellation Full Contact Mapping Catheter: 64-electrode intracardiac mapping catheter."
46399|NCT02307188|P1|Participant Flow|Basket Catheter|"The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms.~Constellation Full Contact Mapping Catheter: 64-electrode intracardiac mapping catheter.~Since enrollment began, a total of five (5) patients consented to enrollment in the study during their atrial fibrillation/tachycardia ablation procedures. The catheter (a new catheter was used for each patient) was used in the left atrium in one patient who met all inclusion criteria and did not have any exclusions."
46400|NCT02307188|O1|Outcome|Basket Catheter|"The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms.~Constellation Full Contact Mapping Catheter: 64-electrode intracardiac mapping catheter.~Five (5) patients were enrolled. The catheters were used in the left atrium in one (1) patient. The remaining patients were excluded because of subtherapeutic ACT levels < 300 seconds (3 patients) or presence of prosthetic valve (1 patient).~Due to the paucity of information collected from the one patient for whom the catheter was used in the left atrium, the collected electrogram data were not analyzed further."
46401|NCT02307188|E1|Reported Event|Basket Catheter|"The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms.~Constellation Full Contact Mapping Catheter: 64-electrode intracardiac mapping catheter.~No adverse events related to this catheter were noted."
46402|NCT02307123|B1|Baseline|HEMS Treated Patients|"Patients whose airways were secured by the HEMS physician.~Intubation: HEMS physician prehospital intubation"
46403|NCT02307123|P1|Participant Flow|HEMS Treated Patients|"Patients whose airways were secured by the HEMS physician.~Intubation: HEMS physician prehospital intubation"
46404|NCT02307123|O1|Outcome|HEMS Treated Patients|"Patients whose airways were secured by the HEMS physician.~Intubation: HEMS physician prehospital intubation"
46405|NCT02307123|O1|Outcome|HEMS Treated Patients|"Patients whose airways were secured by the HEMS physician.~Intubation: HEMS physician prehospital intubation"
46406|NCT02307123|E1|Reported Event|HEMS Treated Patients|"Patients whose airways were secured by the HEMS physician.~Intubation: HEMS physician prehospital intubation"
46407|NCT02306928|B1|Baseline|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.~Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
46408|NCT02306928|P1|Participant Flow|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.~Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
46409|NCT02306928|O1|Outcome|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.~Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
46410|NCT02306928|O1|Outcome|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.~Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
46441|NCT02305381|P3|Participant Flow|Placebo|Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46553|NCT02305238|B3|Baseline|Randomization Failure|Participants entered run-in phase but discontinued the study before randomization after receiving at least one injection.
46411|NCT02306928|O1|Outcome|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.~Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
46412|NCT02306928|O1|Outcome|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.~Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
46413|NCT02306928|O1|Outcome|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.~Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
46414|NCT02306928|E1|Reported Event|Piperacillin Pharmacokinetics|Serious and non-serious adverse advents were not collected.
46415|NCT02306759|B3|Baseline|Total|Total of all reporting groups
46416|NCT02306759|B2|Baseline|Placebo|"Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals~Placebo: Normal saline 50ml, administered over 15 minutes"
46417|NCT02306759|B1|Baseline|Treatment|"Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals~Ketamine: Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes"
46418|NCT02306759|P2|Participant Flow|Placebo|"Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals~Placebo: Normal saline 50ml, administered over 15 minutes"
46419|NCT02306759|P1|Participant Flow|Treatment|"Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals~Ketamine: Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes"
46420|NCT02306759|O2|Outcome|Placebo|Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
46421|NCT02306759|O1|Outcome|Treatment|Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
46422|NCT02306759|O2|Outcome|Placebo|Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
46423|NCT02306759|O1|Outcome|Treatment|Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
46424|NCT02306759|O2|Outcome|Placebo|Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
46425|NCT02306759|O1|Outcome|Treatment|Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
46426|NCT02306759|O2|Outcome|Placebo|Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
46427|NCT02306759|O1|Outcome|Treatment|Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
46428|NCT02306759|O2|Outcome|Placebo|"Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals~Placebo: Normal saline 50ml, administered over 15 minutes"
46429|NCT02306759|O1|Outcome|Treatment|"Ketamine 0.3mg/kg intravenous piggyback (IVPB) in 50ml NS over 15 minutes~Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals~Ketamine: Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes"
46430|NCT02306759|E2|Reported Event|Placebo|Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
46431|NCT02306759|E1|Reported Event|Treatment|Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
46432|NCT02305446|B1|Baseline|rMenB+OMV NZ|Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
46433|NCT02305446|P1|Participant Flow|rMenB+OMV NZ|Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
46434|NCT02305446|O1|Outcome|rMenB+OMV NZ|Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
46435|NCT02305446|O1|Outcome|rMenB+OMV NZ|Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
46436|NCT02305446|E1|Reported Event|rMenB+OMV NZ|Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
46437|NCT02305381|B4|Baseline|Total|Total of all reporting groups
46438|NCT02305381|B3|Baseline|Placebo|Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46439|NCT02305381|B2|Baseline|Semaglutide 1.0 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46440|NCT02305381|B1|Baseline|Semaglutide 0.5 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46545|NCT02305277|O1|Outcome|BIA 9-1067 5 mg CM|BIA 9-1067 5 mg CM CM - clinical micronized
46442|NCT02305381|P2|Participant Flow|Semaglutide 1.0 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30.Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46443|NCT02305381|P1|Participant Flow|Semaglutide 0.5 mg|Subjects received semaglutide 0.25 mg subcutaneous (sc) injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46444|NCT02305381|O3|Outcome|Placebo|Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46445|NCT02305381|O2|Outcome|Semaglutide 1.0 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46446|NCT02305381|O1|Outcome|Semaglutide 0.5 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46447|NCT02305381|O3|Outcome|Placebo|Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46448|NCT02305381|O2|Outcome|Semaglutide 1.0 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46449|NCT02305381|O1|Outcome|Semaglutide 0.5 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46450|NCT02305381|O3|Outcome|Placebo|Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46451|NCT02305381|O2|Outcome|Semaglutide 1.0 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46452|NCT02305381|O1|Outcome|Semaglutide 0.5 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46453|NCT02305381|O3|Outcome|Placebo|Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46454|NCT02305381|O2|Outcome|Semaglutide 1.0 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46455|NCT02305381|O1|Outcome|Semaglutide 0.5 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46456|NCT02305381|O3|Outcome|Placebo|Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46457|NCT02305381|O2|Outcome|Semaglutide 1.0 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46458|NCT02305381|O1|Outcome|Semaglutide 0.5 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46459|NCT02305381|O3|Outcome|Placebo|Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46460|NCT02305381|O2|Outcome|Semaglutide 1.0 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46546|NCT02305277|E6|Reported Event|BIA 9-1067 50 mg TBM|BIA 9-1067 50 mg TBM TBM - to-be-marketed
46461|NCT02305381|O1|Outcome|Semaglutide 0.5 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46462|NCT02305381|O3|Outcome|Placebo|Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46463|NCT02305381|O2|Outcome|Semaglutide 1.0 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46464|NCT02305381|O1|Outcome|Semaglutide 0.5 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46465|NCT02305381|O3|Outcome|Placebo|Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46466|NCT02305381|O2|Outcome|Semaglutide 1.0 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46467|NCT02305381|O1|Outcome|Semaglutide 0.5 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46468|NCT02305381|E3|Reported Event|Placebo|Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46469|NCT02305381|E2|Reported Event|Semaglutide 1.0 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46470|NCT02305381|E1|Reported Event|Semaglutide 0.5 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
46471|NCT02305329|B5|Baseline|Total|Total of all reporting groups
46472|NCT02305329|B4|Baseline|Group 2 BIA 9-1067 50 mg|"Period 1 - 1x50 mg OPC Period 2 - 2x25 mg OPC~BIA 9-1067"
46473|NCT02305329|B3|Baseline|Group 1 BIA 9-1067 50 mg|"Period 1 - 2x25 mg OPC Period 2 - 1x50 mg OPC~BIA 9-1067"
46474|NCT02305329|B2|Baseline|Group 2 BIA 9-1067 25 mg|"Period 1 - 1x25 mg OPC Period 2 - 5x5 mg OPC~BIA 9-1067"
46475|NCT02305329|B1|Baseline|Group 1 BIA 9-1067 25 mg|"Period 1 - 5x5 mg OPC Period 2 - 1x25 mg OPC~BIA 9-1067"
46476|NCT02305329|P4|Participant Flow|Group 2 BIA 9-1067 50 mg|"Period 1 - 1x50 mg OPC Period 2 - 2x25 mg OPC~BIA 9-1067"
46477|NCT02305329|P3|Participant Flow|Group 1 BIA 9-1067 50 mg|"Period 1 - 2x25 mg OPC Period 2 - 1x50 mg OPC~BIA 9-1067"
46478|NCT02305329|P2|Participant Flow|Group 2 BIA 9-1067 25 mg|"Period 1 - 1x25 mg OPC Period 2 - 5x5 mg OPC~BIA 9-1067"
46479|NCT02305329|P1|Participant Flow|Group 1 BIA 9-1067 25 mg|"Period 1 - 5x5 mg OPC Period 2 - 1x25 mg OPC~BIA 9-1067"
46480|NCT02305329|O4|Outcome|1x50 mg BIA 9-1067|1x50 mg BIA 9-1067, OPC
46481|NCT02305329|O3|Outcome|2x25 mg BIA 9-1067|2x25 mg BIA 9-1067, OPC
46482|NCT02305329|O2|Outcome|1x25 mg BIA 9-1067|1x25 mg BIA 9-1067, OPC
46483|NCT02305329|O1|Outcome|5x5mg BIA 9-1067|5x5mg BIA 9-1067, OPC
46484|NCT02305329|O4|Outcome|1x50 mg BIA 9-1067|1x50 mg BIA 9-1067, OPC
46485|NCT02305329|O3|Outcome|2x25 mg BIA 9-1067|2x25 mg BIA 9-1067, OPC
46486|NCT02305329|O2|Outcome|1x25 mg BIA 9-1067|1x25 mg BIA 9-1067, OPC
46487|NCT02305329|O1|Outcome|5x5mg BIA 9-1067|5x5mg BIA 9-1067, OPC
46488|NCT02305329|O4|Outcome|1x50 mg BIA 9-1067|1x50 mg BIA 9-1067, OPC
46489|NCT02305329|O3|Outcome|2x25 mg BIA 9-1067|2x25 mg BIA 9-1067, OPC
46490|NCT02305329|O2|Outcome|1x25 mg BIA 9-1067|1x25 mg BIA 9-1067, OPC
46491|NCT02305329|O1|Outcome|5x5mg BIA 9-1067|5x5mg BIA 9-1067, OPC
46492|NCT02305329|O4|Outcome|1x50 mg BIA 9-1067|1x50 mg BIA 9-1067, OPC
46493|NCT02305329|O3|Outcome|2x25 mg BIA 9-1067|2x25 mg BIA 9-1067, OPC
46494|NCT02305329|O2|Outcome|1x25 mg BIA 9-1067|1x25 mg BIA 9-1067, OPC
46495|NCT02305329|O1|Outcome|5x5mg BIA 9-1067|5x5mg BIA 9-1067, OPC
46496|NCT02305329|E4|Reported Event|1x50 mg BIA 9-1067|1x50 mg BIA 9-1067, OPC
46497|NCT02305329|E3|Reported Event|2x25 mg BIA 9-1067|2x25 mg BIA 9-1067, OPC
46498|NCT02305329|E2|Reported Event|1x25 mg BIA 9-1067|1x25 mg BIA 9-1067, OPC
46499|NCT02305329|E1|Reported Event|5x5mg BIA 9-1067|5x5mg BIA 9-1067, OPC
46500|NCT02305316|B3|Baseline|Total|Total of all reporting groups
46501|NCT02305316|B2|Baseline|BIA 9-1067 Micronized - Non-micronized|"Each subject was orally administered 50 mg OPC micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC non-micronized~BIA 9-1067 non-micronized~BIA 9-1067 micronized"
46547|NCT02305277|E5|Reported Event|BIA 9-1067 50 mg CM|BIA 9-1067 50 mg CM CM - clinical micronized
68275|NCT02151461|O3|Outcome|FDC500|Leucine 1100mg +Metformin 500mg
46502|NCT02305316|B1|Baseline|BIA 9-1067 Non-micronized - Micronized|"Each subject was orally administered with 50 mg OPC non-micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC micronized~BIA 9-1067 non-micronized~BIA 9-1067 micronized"
46503|NCT02305316|P2|Participant Flow|BIA 9-1067 Micronized - Non-micronized|"Each subject was orally administered 50 mg OPC micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC non-micronized~BIA 9-1067 non-micronized~BIA 9-1067 micronized"
46504|NCT02305316|P1|Participant Flow|BIA 9-1067 Non-micronized - Micronized|"Each subject was orally administered with 50 mg OPC non-micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC micronized~BIA 9-1067 non-micronized~BIA 9-1067 micronized"
46505|NCT02305316|O2|Outcome|BIA 9-1067 Micronized|BIA 9-1067 micronized.
46506|NCT02305316|O1|Outcome|BIA 9-1067 Non-micronized|BIA 9-1067 non-micronized.
46507|NCT02305316|O2|Outcome|BIA 9-1067 Micronized|BIA 9-1067 micronized.
46508|NCT02305316|O1|Outcome|BIA 9-1067 Non-micronized|BIA 9-1067 non-micronized.
46509|NCT02305316|O2|Outcome|BIA 9-1067 Micronized|BIA 9-1067 micronized.
46510|NCT02305316|O1|Outcome|BIA 9-1067 Non-micronized|BIA 9-1067 non-micronized.
46511|NCT02305316|O2|Outcome|BIA 9-1067 Micronized|BIA 9-1067 micronized.
46512|NCT02305316|O1|Outcome|BIA 9-1067 Non-micronized|BIA 9-1067 non-micronized.
46513|NCT02305316|E2|Reported Event|BIA 9-1067 Micronized|BIA 9-1067 micronized.
46514|NCT02305316|E1|Reported Event|BIA 9-1067 Non-micronized|BIA 9-1067 non-micronized.
46515|NCT02305277|B7|Baseline|Total|Total of all reporting groups
46516|NCT02305277|B6|Baseline|BIA 9-1067 50 mg Sequence 2|"volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
46517|NCT02305277|B5|Baseline|BIA 9-1067 25 mg Sequence 2|"volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
46518|NCT02305277|B4|Baseline|BIA 9-1067 5 mg Sequence 2|"volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
46519|NCT02305277|B3|Baseline|BIA 9-1067 50 mg Sequence 1|"volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
46520|NCT02305277|B2|Baseline|BIA 9-1067 25 mg Sequence 1|"volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
46521|NCT02305277|B1|Baseline|BIA 9-1067 5 mg Sequence 1|"volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
46522|NCT02305277|P6|Participant Flow|BIA 9-1067 50 mg Sequence 2|"volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
46523|NCT02305277|P5|Participant Flow|BIA 9-1067 25 mg Sequence 2|"volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
46524|NCT02305277|P4|Participant Flow|BIA 9-1067 5 mg Sequence 2|"volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
46525|NCT02305277|P3|Participant Flow|BIA 9-1067 50 mg Sequence 1|"volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
46526|NCT02305277|P2|Participant Flow|BIA 9-1067 25 mg Sequence 1|"volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
46527|NCT02305277|P1|Participant Flow|BIA 9-1067 5 mg Sequence 1|"volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
46528|NCT02305277|O6|Outcome|BIA 9-1067 50 mg TBM|BIA 9-1067 50 mg TBM TBM - to-be-marketed
46529|NCT02305277|O5|Outcome|BIA 9-1067 50 mg CM|BIA 9-1067 50 mg CM CM - clinical micronized
46530|NCT02305277|O4|Outcome|BIA 9-1067 25 mg TBM|BIA 9-1067 25 mg TBM TBM - to-be-marketed
46531|NCT02305277|O3|Outcome|BIA 9-1067 25 mg CM|BIA 9-1067 25 mg CM CM - clinical micronized
46532|NCT02305277|O2|Outcome|BIA 9-1067 5 mg TBM|BIA 9-1067 5 mg TBM TBM - to-be-marketed
46533|NCT02305277|O1|Outcome|BIA 9-1067 5 mg CM|BIA 9-1067 5 mg CM CM - clinical micronized
46534|NCT02305277|O6|Outcome|BIA 9-1067 50 mg TBM|BIA 9-1067 50 mg TBM TBM - to-be-marketed
46535|NCT02305277|O5|Outcome|BIA 9-1067 50 mg CM|BIA 9-1067 50 mg CM CM - clinical micronized
46536|NCT02305277|O4|Outcome|BIA 9-1067 25 mg TBM|BIA 9-1067 25 mg TBM TBM - to-be-marketed
46537|NCT02305277|O3|Outcome|BIA 9-1067 25 mg CM|BIA 9-1067 25 mg CM CM - clinical micronized
46538|NCT02305277|O2|Outcome|BIA 9-1067 5 mg TBM|BIA 9-1067 5 mg TBM TBM - to-be-marketed
46539|NCT02305277|O1|Outcome|BIA 9-1067 5 mg CM|BIA 9-1067 5 mg CM CM - clinical micronized
46540|NCT02305277|O6|Outcome|BIA 9-1067 50 mg TBM|BIA 9-1067 50 mg TBM TBM - to-be-marketed
46541|NCT02305277|O5|Outcome|BIA 9-1067 50 mg CM|BIA 9-1067 50 mg CM CM - clinical micronized
46542|NCT02305277|O4|Outcome|BIA 9-1067 25 mg TBM|BIA 9-1067 25 mg TBM TBM - to-be-marketed
46543|NCT02305277|O3|Outcome|BIA 9-1067 25 mg CM|BIA 9-1067 25 mg CM CM - clinical micronized
46544|NCT02305277|O2|Outcome|BIA 9-1067 5 mg TBM|BIA 9-1067 5 mg TBM TBM - to-be-marketed
46554|NCT02305238|B2|Baseline|4 Weeks Adjustment|Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals. In the case the study eye of a participant met the criteria of the shortening, the length of the treatment interval was to be shortened by 2 weeks. But when the last treatment interval for a participant was extended by 4 weeks from the second last interval, the treatment interval was shortened by 4 weeks. In the case the study eye of a participant met the criteria of the extension, the length of the treatment interval was to be extended by 4 weeks. But when a participant had a history of receiving treatment with interval shortened by 4 weeks during this study, the length of the extension was 2 weeks. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
46555|NCT02305238|B1|Baseline|2 Weeks Adjustment|Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals with the criteria of Treat and Extend regimen. In the case the study eye of a participant met the criteria, the length of treatment interval was to be extended or shortened by 2 weeks from the last interval, respectively. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
46556|NCT02305238|P3|Participant Flow|Randomization Failure|Participants entered run-in phase but discontinued the study before randomization after receiving at least one injection.
46557|NCT02305238|P2|Participant Flow|4 Weeks Adjustment|Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals. In the case the study eye of a participant met the criteria of the shortening, the length of the treatment interval was to be shortened by 2 weeks. But when the last treatment interval for a participant was extended by 4 weeks from the second last interval, the treatment interval was shortened by 4 weeks. In the case the study eye of a participant met the criteria of the extension, the length of the treatment interval was to be extended by 4 weeks. But when a participant had a history of receiving treatment with interval shortened by 4 weeks during this study, the length of the extension was 2 weeks. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
46558|NCT02305238|P1|Participant Flow|2 Weeks Adjustment|Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals with the criteria of Treat and Extend regimen. In the case the study eye of a participant met the criteria, the length of treatment interval was to be extended or shortened by 2 weeks from the last interval, respectively. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
46559|NCT02305238|O2|Outcome|4 Weeks Adjustment|Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals. In the case the study eye of a participant met the criteria of the shortening, the length of the treatment interval was to be shortened by 2 weeks. But when the last treatment interval for a participant was extended by 4 weeks from the second last interval, the treatment interval was shortened by 4 weeks. In the case the study eye of a participant met the criteria of the extension, the length of the treatment interval was to be extended by 4 weeks. But when a participant had a history of receiving treatment with interval shortened by 4 weeks during this study, the length of the extension was 2 weeks. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
46560|NCT02305238|O1|Outcome|2 Weeks Adjustment|Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals with the criteria of Treat and Extend regimen. In the case the study eye of a participant met the criteria, the length of treatment interval was to be extended or shortened by 2 weeks from the last interval, respectively. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
46561|NCT02305238|O2|Outcome|4 Weeks Adjustment|Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals. In the case the study eye of a participant met the criteria of the shortening, the length of the treatment interval was to be shortened by 2 weeks. But when the last treatment interval for a participant was extended by 4 weeks from the second last interval, the treatment interval was shortened by 4 weeks. In the case the study eye of a participant met the criteria of the extension, the length of the treatment interval was to be extended by 4 weeks. But when a participant had a history of receiving treatment with interval shortened by 4 weeks during this study, the length of the extension was 2 weeks. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
46562|NCT02305238|O1|Outcome|2 Weeks Adjustment|Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals with the criteria of Treat and Extend regimen. In the case the study eye of a participant met the criteria, the length of treatment interval was to be extended or shortened by 2 weeks from the last interval, respectively. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
46563|NCT02305238|O2|Outcome|4 Weeks Adjustment|Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals. In the case the study eye of a participant met the criteria of the shortening, the length of the treatment interval was to be shortened by 2 weeks. But when the last treatment interval for a participant was extended by 4 weeks from the second last interval, the treatment interval was shortened by 4 weeks. In the case the study eye of a participant met the criteria of the extension, the length of the treatment interval was to be extended by 4 weeks. But when a participant had a history of receiving treatment with interval shortened by 4 weeks during this study, the length of the extension was 2 weeks. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
46564|NCT02305238|O1|Outcome|2 Weeks Adjustment|Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals with the criteria of Treat and Extend regimen. In the case the study eye of a participant met the criteria, the length of treatment interval was to be extended or shortened by 2 weeks from the last interval, respectively. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
46590|NCT02304926|P2|Participant Flow|Ezetimibe|"20 hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46788|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
46565|NCT02305238|O2|Outcome|4 Weeks Adjustment|Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals. In the case the study eye of a participant met the criteria of the shortening, the length of the treatment interval was to be shortened by 2 weeks. But when the last treatment interval for a participant was extended by 4 weeks from the second last interval, the treatment interval was shortened by 4 weeks. In the case the study eye of a participant met the criteria of the extension, the length of the treatment interval was to be extended by 4 weeks. But when a participant had a history of receiving treatment with interval shortened by 4 weeks during this study, the length of the extension was 2 weeks. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
46566|NCT02305238|O1|Outcome|2 Weeks Adjustment|Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals with the criteria of Treat and Extend regimen. In the case the study eye of a participant met the criteria, the length of treatment interval was to be extended or shortened by 2 weeks from the last interval, respectively. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
46567|NCT02305238|O2|Outcome|4 Weeks Adjustment|Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals. In the case the study eye of a participant met the criteria of the shortening, the length of the treatment interval was to be shortened by 2 weeks. But when the last treatment interval for a participant was extended by 4 weeks from the second last interval, the treatment interval was shortened by 4 weeks. In the case the study eye of a participant met the criteria of the extension, the length of the treatment interval was to be extended by 4 weeks. But when a participant had a history of receiving treatment with interval shortened by 4 weeks during this study, the length of the extension was 2 weeks. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
46568|NCT02305238|O1|Outcome|2 Weeks Adjustment|Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals with the criteria of Treat and Extend regimen. In the case the study eye of a participant met the criteria, the length of treatment interval was to be extended or shortened by 2 weeks from the last interval, respectively. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
46569|NCT02305238|E3|Reported Event|Randomization Failure|Participants entered run-in phase but discontinued the study before randomization after receiving at least one injection.
46570|NCT02305238|E2|Reported Event|4 Weeks Adjustment|Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals. In the case the study eye of a participant met the criteria of the shortening, the length of the treatment interval was to be shortened by 2 weeks. But when the last treatment interval for a participant was extended by 4 weeks from the second last interval, the treatment interval was shortened by 4 weeks. In the case the study eye of a participant met the criteria of the extension, the length of the treatment interval was to be extended by 4 weeks. But when a participant had a history of receiving treatment with interval shortened by 4 weeks during this study, the length of the extension was 2 weeks. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
46571|NCT02305238|E1|Reported Event|2 Weeks Adjustment|Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals with the criteria of Treat and Extend regimen. In the case the study eye of a participant met the criteria, the length of treatment interval was to be extended or shortened by 2 weeks from the last interval, respectively. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
46572|NCT02305017|B3|Baseline|Total|Total of all reporting groups
46573|NCT02305017|B2|Baseline|Period 1 OPC; Period 2 OPC+ Paracetamol|"Period 1 BIA 9-1067 (Opicapone, OPC) Period 2 BIA 9-1067 (Opicapone, OPC) + Paracetamol;~BIA 9-1067: BIA 9-1067 50 mg~Paracetamol: Paracetamol 1g"
46574|NCT02305017|B1|Baseline|Period 1 OPC + Paracetamol; Period 2 OPC|"Period 1 BIA 9-1067 (Opicapone, OPC) + Paracetamol; Period 2 BIA 9-1067 (Opicapone, OPC)~BIA 9-1067: BIA 9-1067 50 mg~Paracetamol: Paracetamol 1g"
46575|NCT02305017|P2|Participant Flow|Period 1 OPC; Period 2 OPC+ Paracetamol|"Period 1 BIA 9-1067 (Opicapone, OPC) Period 2 BIA 9-1067 (Opicapone, OPC) + Paracetamol;~BIA 9-1067: BIA 9-1067 50 mg~Paracetamol: Paracetamol 1g"
46576|NCT02305017|P1|Participant Flow|Period 1 OPC + Paracetamol; Period 2 OPC|"Period 1 BIA 9-1067 (Opicapone, OPC) + Paracetamol; Period 2 BIA 9-1067 (Opicapone, OPC)~BIA 9-1067: BIA 9-1067 50 mg~Paracetamol: Paracetamol 1g"
46577|NCT02305017|O2|Outcome|Opicapone Plus Paracetamol|Opicapone, OPC, BIA 9-1067 50 mg Paracetamol, acetominophen, 1 g
46578|NCT02305017|O1|Outcome|Opicapone Alone|Opicapone, OPC, BIA 9-1067 50 mg
46579|NCT02305017|O2|Outcome|Opicapone Plus Paracetamol|Opicapone, OPC, BIA 9-1067 50 mg Paracetamol, acetominophen, 1 g
46580|NCT02305017|O1|Outcome|Opicapone Alone|Opicapone, OPC, BIA 9-1067 50 mg
46581|NCT02305017|O2|Outcome|Opicapone Plus Paracetamol|Opicapone, OPC, BIA 9-1079 Paracetamol, acetominphen
46582|NCT02305017|O1|Outcome|Opicapone Alone|Opicapone, OPC, BIA 9-1079
46583|NCT02305017|O2|Outcome|Opicapone Plus Paracetamol|Opicapone, OPC, BIA 9-1079 Paracetamol acetominophen
46584|NCT02305017|O1|Outcome|Opicapone Alone|Opicapone, OPC, BIA 9-1079 alone
46585|NCT02305017|E2|Reported Event|Opicapone Plus Paracetamol|Opicapone, OPC, BIA 9-1079 Paracetamol acetominophen
46586|NCT02305017|E1|Reported Event|Opicapone Alone|Opicapone, OPC, BIA 9-1079 alone
46587|NCT02304926|B3|Baseline|Total|Total of all reporting groups
46588|NCT02304926|B2|Baseline|Ezetimibe|"20 hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46589|NCT02304926|B1|Baseline|Simvastatin|"20 hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46591|NCT02304926|P1|Participant Flow|Simvastatin|"20 hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46592|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46593|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46594|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46595|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46596|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46597|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46598|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46599|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46600|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46601|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46602|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46603|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46604|NCT02304926|O2|Outcome|Ezetimibe|"19 hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46901|NCT02301169|B3|Baseline|Total|Total of all reporting groups
68276|NCT02151461|O2|Outcome|FDC250|Leucine 1100mg +Metformin 250mg
46605|NCT02304926|O1|Outcome|Simvastatin|"20 hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46606|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46607|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46608|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46609|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46610|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46611|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46612|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46613|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46614|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46615|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46616|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46617|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46618|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
47502|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
46619|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46620|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46621|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46622|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46623|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46624|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46625|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46626|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46627|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46628|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46629|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46630|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46631|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
46632|NCT02304926|E2|Reported Event|Not Available|Adverse events were not collected
46633|NCT02304926|E1|Reported Event|Adverse Events Were Not Collected|Adverse events were not collected
46634|NCT02304432|B1|Baseline|All Study Participants|"Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule for 8 weeks.~D-cycloserine: Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.~Add crossover phase and second OL phase"
47503|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
46635|NCT02304432|P4|Participant Flow|Second Open Label DCS|"Both participants received second open label exposures to D-cycloserine (seromycin), 50 mg/d capsule for 24 weeks.~D-cycloserine: Both participants received second open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks."
46636|NCT02304432|P3|Participant Flow|DCS First, Then Placebo|One of the sequences during the DB period; dose of DCS, freq of admin; length of trial
46637|NCT02304432|P2|Participant Flow|Placebo First, Then DCS|"One of the sequences during the DB period; dose of DCS, freq of admin; length of trial~Randomized to DCS or placebo. Participants underwent double-blind placebo-controlled exposures to DCS for 6 weeks or placebo for 6 weeks. One participant received exposure to DCS for 6 weeks and then received placebo dosing for 6 weeks. The other participant received exposure to placebo dosing for 6 weeks and then DCS for 6 weeks.~D-cycloserine: Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.~DCS or placebo: Double-blind placebo-controlled exposures to DCS or placebo x 6 weeks. One participant received exposure to DCS x 6 weeks and then received placebo dosing x 6 weeks. The other participant received exposure to placebo dosing x 6 weeks and then DCS x 6 weeks."
46638|NCT02304432|P1|Participant Flow|Open Label DCS|"Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule for 8 weeks.~D-cycloserine: Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks."
46639|NCT02304432|O1|Outcome|First Open Label DCS|The subject received the first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks and was tested at the beginning of week 8.
46640|NCT02304432|O1|Outcome|First Open Label DCS|The subject received the first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks and was tested at the beginning of week 8.
46641|NCT02304432|O1|Outcome|First Open Label DCS|The subject received the first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks and was tested at the beginning of week 8.
46642|NCT02304432|O1|Outcome|First Open Label DCS|The subject received the first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks and was tested at the beginning of week 8.
46643|NCT02304432|O1|Outcome|Open Label DCS|During the first open label period, both participants received D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks. During the second open-label period, both participants received D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks. OOne subject was tested at the beginning of week 8 of the first open-label period and the other subject was tested at the beginning of week 8 of the second open-label period.
46644|NCT02304432|O1|Outcome|Open Label DCS|During the first open label period, both participants received D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks. During the second open-label period, both participants received D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks. One subject was tested at the beginning of week 8 of the first open-label period and the other subject was tested at the beginning of week 8 of the second open-label period.
46645|NCT02304432|O2|Outcome|DCS First, Then Placebo|One of the sequences during the DB period; dose of DCS, freq of admin; length of trial
46646|NCT02304432|O1|Outcome|Placebo First, Then DCS|"One of the sequences during the DB period; dose of DCS, freq of admin; length of trial~Randomized to DCS or placebo. Participants underwent double-blind placebo-controlled exposures to DCS for 6 weeks or placebo for 6 weeks. One participant received exposure to DCS for 6 weeks and then received placebo dosing for 6 weeks. The other participant received exposure to placebo dosing for 6 weeks and then DCS for 6 weeks.~D-cycloserine: Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.~DCS or placebo: Double-blind placebo-controlled exposures to DCS or placebo x 6 weeks. One participant received exposure to DCS x 6 weeks and then received placebo dosing x 6 weeks. The other participant received exposure to placebo dosing x 6 weeks and then DCS x 6 weeks."
46647|NCT02304432|O2|Outcome|DCS First, Then Placebo|One of the sequences during the DB period; dose of DCS, freq of admin; length of trial
46648|NCT02304432|O1|Outcome|Placebo First, Then DCS|"One of the sequences during the DB period; dose of DCS, freq of admin; length of trial~Randomized to DCS or placebo. Participants underwent double-blind placebo-controlled exposures to DCS for 6 weeks or placebo for 6 weeks. One participant received exposure to DCS for 6 weeks and then received placebo dosing for 6 weeks. The other participant received exposure to placebo dosing for 6 weeks and then DCS for 6 weeks.~D-cycloserine: Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.~DCS or placebo: Double-blind placebo-controlled exposures to DCS or placebo x 6 weeks. One participant received exposure to DCS x 6 weeks and then received placebo dosing x 6 weeks. The other participant received exposure to placebo dosing x 6 weeks and then DCS x 6 weeks."
46649|NCT02304432|O2|Outcome|Second Open Label DCS|Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
46650|NCT02304432|O1|Outcome|First Open Label DCS|Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
46651|NCT02304432|O2|Outcome|Second Open Label DCS|Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
46652|NCT02304432|O1|Outcome|First Open Label DCS|Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
46653|NCT02304432|O2|Outcome|DCS First, Then Placebo|One of the sequences during the DB period; dose of DCS, freq of admin; length of trial
46654|NCT02304432|O1|Outcome|Placebo First, Then DCS|"One of the sequences during the DB period; dose of DCS, freq of admin; length of trial~Randomized to DCS or placebo. Participants underwent double-blind placebo-controlled exposures to DCS for 6 weeks or placebo for 6 weeks. One participant received exposure to DCS for 6 weeks and then received placebo dosing for 6 weeks. The other participant received exposure to placebo dosing for 6 weeks and then DCS for 6 weeks.~D-cycloserine: Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.~DCS or placebo: Double-blind placebo-controlled exposures to DCS or placebo x 6 weeks. One participant received exposure to DCS x 6 weeks and then received placebo dosing x 6 weeks. The other participant received exposure to placebo dosing x 6 weeks and then DCS x 6 weeks."
46655|NCT02304432|O2|Outcome|Second Open Label DCS|Both participants received second open label exposures to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
46656|NCT02304432|O1|Outcome|First Open Label DCS|Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
46657|NCT02304432|O2|Outcome|DCS First, Then Placebo|One of the sequences during the DB period; dose of DCS, freq of admin; length of trial
46658|NCT02304432|O1|Outcome|Placebo First, Then DCS|"One of the sequences during the DB period; dose of DCS, freq of admin; length of trial~Randomized to DCS or placebo. Participants underwent double-blind placebo-controlled exposures to DCS for 6 weeks or placebo for 6 weeks. One participant received exposure to DCS for 6 weeks and then received placebo dosing for 6 weeks. The other participant received exposure to placebo dosing for 6 weeks and then DCS for 6 weeks.~D-cycloserine: Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.~DCS or placebo: Double-blind placebo-controlled exposures to DCS or placebo x 6 weeks. One participant received exposure to DCS x 6 weeks and then received placebo dosing x 6 weeks. The other participant received exposure to placebo dosing x 6 weeks and then DCS x 6 weeks."
46659|NCT02304432|O2|Outcome|Second Open Label DCS|Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
46660|NCT02304432|O1|Outcome|First Open Label DCS|Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
46661|NCT02304432|O2|Outcome|DCS First, Then Placebo|One of the sequences during the DB period; dose of DCS, freq of admin; length of trial
46662|NCT02304432|O1|Outcome|Placebo First, Then DCS|"One of the sequences during the DB period; dose of DCS, freq of admin; length of trial~Randomized to DCS or placebo. Participants underwent double-blind placebo-controlled exposures to DCS for 6 weeks or placebo for 6 weeks. One participant received exposure to DCS for 6 weeks and then received placebo dosing for 6 weeks. The other participant received exposure to placebo dosing for 6 weeks and then DCS for 6 weeks.~D-cycloserine: Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.~DCS or placebo: Double-blind placebo-controlled exposures to DCS or placebo x 6 weeks. One participant received exposure to DCS x 6 weeks and then received placebo dosing x 6 weeks. The other participant received exposure to placebo dosing x 6 weeks and then DCS x 6 weeks."
46663|NCT02304432|O2|Outcome|Second Open Label DCS|Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
46664|NCT02304432|O1|Outcome|First Open Label DCS|Both participants received first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
46665|NCT02304432|E4|Reported Event|Second Open Label DCS|"Both participants received second open label exposures to D-cycloserine (seromycin), 50 mg/d capsule for 24 weeks.~D-cycloserine: Both participants received second open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks."
46666|NCT02304432|E3|Reported Event|PLACEBO (CROSSOVER)|Both participants received placebo for 6 weeks.
46667|NCT02304432|E2|Reported Event|DCS (Crossover)|Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, for 6 weeks.
46668|NCT02304432|E1|Reported Event|Open Label DCS|Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
46669|NCT02303743|B3|Baseline|Total|Total of all reporting groups
46670|NCT02303743|B2|Baseline|Control Group|"Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution~Written instructions with visual aids: written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group)."
46671|NCT02303743|B1|Baseline|Smart Phone Application (SPA) Group|"Patients assigned to SPA group were instructed on how to free-download the application onto their smartphone. Each patient enters the date and time of his colonoscopy and timed alerts appeared on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app assists in bowel preparation by explaining the procedure, providing tips, examples of low fiber diet, and displaying pictures of preparation quality and educational video to explain how to prepare the purgative solution.Finally, the patient can obtain a checklist to confirm all steps.~Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure"
46672|NCT02303743|P2|Participant Flow|Control Group|"Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution~Written instructions with visual aids: written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group)."
46673|NCT02303743|P1|Participant Flow|Smart Phone Application (SPA) Group|"Patients assigned to SPA group were instructed on how to free-download the application onto their smartphone. Each patient enters the date and time of his colonoscopy and timed alerts appeared on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app assists in bowel preparation by explaining the procedure, providing tips, examples of low fiber diet, and displaying pictures of preparation quality and educational video to explain how to prepare the purgative solution.Finally, the patient can obtain a checklist to confirm all steps.~Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure"
46674|NCT02303743|O2|Outcome|Control Group|"Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution~Written instructions with visual aids: written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group)."
46675|NCT02303743|O1|Outcome|Smart Phone Application (SPA) Group|"Patients assigned to SPA group were instructed on how to free-download the application onto their smartphone. Each patient enters the date and time of his colonoscopy and timed alerts appeared on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app assists in bowel preparation by explaining the procedure, providing tips, examples of low fiber diet, and displaying pictures of preparation quality and educational video to explain how to prepare the purgative solution.Finally, the patient can obtain a checklist to confirm all steps.~Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure"
46676|NCT02303743|O2|Outcome|Control Group|"Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution~Written instructions with visual aids: written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group)."
46704|NCT02302807|O2|Outcome|Atezolizumab|Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
46677|NCT02303743|O1|Outcome|Smart Phone Application (SPA) Group|"Patients assigned to SPA group were instructed on how to free-download the application onto their smartphone. Each patient enters the date and time of his colonoscopy and timed alerts appeared on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app assists in bowel preparation by explaining the procedure, providing tips, examples of low fiber diet, and displaying pictures of preparation quality and educational video to explain how to prepare the purgative solution.Finally, the patient can obtain a checklist to confirm all steps.~Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure"
46678|NCT02303743|E2|Reported Event|Control Group|"Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution~Written instructions with visual aids: written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group)."
46679|NCT02303743|E1|Reported Event|Smart Phone Application (SPA) Group|"Patients assigned to SPA group were instructed on how to free-download the application onto their smartphone. Each patient enters the date and time of his colonoscopy and timed alerts appeared on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app assists in bowel preparation by explaining the procedure, providing tips, examples of low fiber diet, and displaying pictures of preparation quality and educational video to explain how to prepare the purgative solution.Finally, the patient can obtain a checklist to confirm all steps.~Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure"
46680|NCT02303704|B3|Baseline|Total|Total of all reporting groups
46681|NCT02303704|B2|Baseline|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
46682|NCT02303704|B1|Baseline|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts
46683|NCT02303704|P2|Participant Flow|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
46684|NCT02303704|P1|Participant Flow|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
46685|NCT02303704|O2|Outcome|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
46686|NCT02303704|O1|Outcome|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
46687|NCT02303704|O2|Outcome|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
46688|NCT02303704|O1|Outcome|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
46689|NCT02303704|O2|Outcome|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
46690|NCT02303704|O1|Outcome|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
46691|NCT02303704|O2|Outcome|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
46692|NCT02303704|O1|Outcome|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
46693|NCT02303704|O2|Outcome|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
46694|NCT02303704|O1|Outcome|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
46695|NCT02303704|O2|Outcome|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
46696|NCT02303704|O1|Outcome|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
46697|NCT02303704|E2|Reported Event|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
46698|NCT02303704|E1|Reported Event|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
46699|NCT02302807|B3|Baseline|Total|Total of all reporting groups
46700|NCT02302807|B2|Baseline|Atezolizumab|Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
46701|NCT02302807|B1|Baseline|Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)|Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
46702|NCT02302807|P2|Participant Flow|Atezolizumab|Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
46703|NCT02302807|P1|Participant Flow|Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)|Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
46781|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
46705|NCT02302807|O1|Outcome|Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)|Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
46706|NCT02302807|O2|Outcome|Atezolizumab|Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
46707|NCT02302807|O1|Outcome|Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)|Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
46708|NCT02302807|O2|Outcome|Atezolizumab|Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
46709|NCT02302807|O1|Outcome|Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)|Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
46710|NCT02302807|O1|Outcome|Atezolizumab|Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
46711|NCT02302807|O6|Outcome|IC1/2/3 Atezolizumab|PD-L1 immunohistochemistry (IHC) score of IC1/2/3
46712|NCT02302807|O5|Outcome|IC1/2/3 Chemotherapy|PD-L1 immunohistochemistry (IHC) score of IC1/2/3
46713|NCT02302807|O4|Outcome|IC2/3 Atezolizumab|PD-L1 immunohistochemistry (IHC) score of IC2/3
46714|NCT02302807|O3|Outcome|IC2/3 Chemotherapy|PD-L1 immunohistochemistry (IHC) score of IC2/3
46715|NCT02302807|O2|Outcome|Atezolizumab|Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
46716|NCT02302807|O1|Outcome|Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)|Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
46717|NCT02302807|O1|Outcome|Atezolizumab|Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
46718|NCT02302807|O3|Outcome|IC2/3 Atezolizumab|PD-L1 immunohistochemistry (IHC) score of IC2/3
46719|NCT02302807|O2|Outcome|IC1/2/3 Atezolizumab|PD-L1 immunohistochemistry (IHC) score of IC2/3
46720|NCT02302807|O1|Outcome|Atezolizumab|Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
46721|NCT02302807|O6|Outcome|IC1/2/3 Atezolizumab|PD-L1 immunohistochemistry (IHC) score of IC1/2/3
46722|NCT02302807|O5|Outcome|IC1/2/3 Chemotherapy|PD-L1 immunohistochemistry (IHC) score of IC1/2/3
46723|NCT02302807|O4|Outcome|IC2/3 Atezolizumab|PD-L1 immunohistochemistry (IHC) score of IC2/3
46724|NCT02302807|O3|Outcome|IC2/3 Chemotherapy|PD-L1 immunohistochemistry (IHC) score of IC2/3
46725|NCT02302807|O2|Outcome|Atezolizumab|Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
46726|NCT02302807|O1|Outcome|Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)|Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
46727|NCT02302807|O6|Outcome|IC1/2/3 Atezolizumab|PD-L1 immunohistochemistry (IHC) score of IC1/2/3
46728|NCT02302807|O5|Outcome|IC1/2/3 Chemotherapy|PD-L1 immunohistochemistry (IHC) score of IC1/2/3
46729|NCT02302807|O4|Outcome|IC2/3 Atezolizumab|PD-L1 immunohistochemistry (IHC) score of IC2/3
46730|NCT02302807|O3|Outcome|IC2/3 Chemotherapy|PD-L1 immunohistochemistry (IHC) score of IC2/3
46731|NCT02302807|O2|Outcome|Atezolizumab|Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
46782|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
46783|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
46732|NCT02302807|O1|Outcome|Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)|Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
46733|NCT02302807|O6|Outcome|IC1/2/3 Atezolizumab|PD-L1 immunohistochemistry (IHC) score of IC1/2/3
46734|NCT02302807|O5|Outcome|IC1/2/3 Chemotherapy|PD-L1 immunohistochemistry (IHC) score of IC1/2/3
46735|NCT02302807|O4|Outcome|IC2/3 Atezolizumab|PD-L1 immunohistochemistry (IHC) score of IC2/3
46736|NCT02302807|O3|Outcome|IC2/3 Chemotherapy|PD-L1 immunohistochemistry (IHC) score of IC2/3
46737|NCT02302807|O2|Outcome|Atezolizumab|Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
46738|NCT02302807|O1|Outcome|Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)|Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
46739|NCT02302807|O6|Outcome|Atezolizumab|Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
46740|NCT02302807|O5|Outcome|Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)|Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
46741|NCT02302807|O4|Outcome|IC1/2/3 Atezolizumab|PD-L1 immunohistochemistry (IHC) score of IC1/2/3
46742|NCT02302807|O3|Outcome|IC1/2/3 Chemotherapy|PD-L1 immunohistochemistry (IHC) score of IC1/2/3
46743|NCT02302807|O2|Outcome|IC2/3 Atezolizumab|PD-L1 immunohistochemistry (IHC) score of IC2/3
46744|NCT02302807|O1|Outcome|IC2/3 Chemotherapy|PD-L1 immunohistochemistry (IHC) score of IC2/3
46745|NCT02302807|E2|Reported Event|Atezolizumab|Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
46746|NCT02302807|E1|Reported Event|Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)|Participants randomized to the chemotherapy arm will receive vinflunine, paclitaxel, or docetaxel per the investigator's choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
46747|NCT02302716|B3|Baseline|Total|Total of all reporting groups
46748|NCT02302716|B2|Baseline|LANTUS®|Insulin naive participants started on 10 U LANTUS® given SC QD for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or NPH QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46749|NCT02302716|B1|Baseline|LY2963016|Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or neutral protamine Hagedorn (NPH) QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day (BID) were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46750|NCT02302716|P2|Participant Flow|LANTUS®|Insulin naive participants started on 10 U LANTUS® given SC QD for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or NPH QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46751|NCT02302716|P1|Participant Flow|LY2963016|Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or neutral protamine Hagedorn (NPH) QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day (BID) were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46752|NCT02302716|O2|Outcome|LANTUS®|Insulin naive participants started on 10 U LANTUS® given SC QD for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or NPH QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46784|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
46785|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
47504|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
46753|NCT02302716|O1|Outcome|LY2963016|Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or neutral protamine Hagedorn (NPH) QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day (BID) were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46754|NCT02302716|O2|Outcome|LANTUS®|Insulin naive participants started on 10 U LANTUS® given SC QD for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or NPH QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46755|NCT02302716|O1|Outcome|LY2963016|Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or neutral protamine Hagedorn (NPH) QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day (BID) were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46756|NCT02302716|O2|Outcome|LANTUS®|Insulin naive participants started on 10 U LANTUS® given SC QD for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or NPH QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46757|NCT02302716|O1|Outcome|LY2963016|Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or neutral protamine Hagedorn (NPH) QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day (BID) were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46758|NCT02302716|O2|Outcome|LANTUS®|Insulin naive participants started on 10 U LANTUS® given SC QD for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or NPH QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46759|NCT02302716|O1|Outcome|LY2963016|Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or neutral protamine Hagedorn (NPH) QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day (BID) were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46760|NCT02302716|O2|Outcome|LANTUS®|Insulin naive participants started on 10 U LANTUS® given SC QD for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or NPH QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46761|NCT02302716|O1|Outcome|LY2963016|Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or neutral protamine Hagedorn (NPH) QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day (BID) were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46762|NCT02302716|O2|Outcome|LANTUS®|Insulin naive participants started on 10 U LANTUS® given SC QD for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or NPH QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46763|NCT02302716|O1|Outcome|LY2963016|Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or neutral protamine Hagedorn (NPH) QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day (BID) were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46764|NCT02302716|O2|Outcome|LANTUS®|Insulin naive participants started on 10 U LANTUS® given SC QD for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or NPH QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46786|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
46787|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
68277|NCT02151461|O1|Outcome|FDC125|Leucine 1100mg +Metformin 125mg
46765|NCT02302716|O1|Outcome|LY2963016|Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or neutral protamine Hagedorn (NPH) QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day (BID) were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46766|NCT02302716|O2|Outcome|LANTUS®|Insulin naive participants started on 10 U LANTUS® given SC QD for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or NPH QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46767|NCT02302716|O1|Outcome|LY2963016|Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or neutral protamine Hagedorn (NPH) QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day (BID) were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46768|NCT02302716|O2|Outcome|LANTUS®|Insulin naive participants started on 10 U LANTUS® given SC QD for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or NPH QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46769|NCT02302716|O1|Outcome|LY2963016|Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or neutral protamine Hagedorn (NPH) QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day (BID) were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46770|NCT02302716|O2|Outcome|LANTUS®|Insulin naive participants started on 10 U LANTUS® given SC QD for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or NPH QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46771|NCT02302716|O1|Outcome|LY2963016|Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or neutral protamine Hagedorn (NPH) QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day (BID) were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46772|NCT02302716|O2|Outcome|LANTUS®|Insulin naive participants started on 10 U LANTUS® given SC QD for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or NPH QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46773|NCT02302716|O1|Outcome|LY2963016|Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or neutral protamine Hagedorn (NPH) QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day (BID) were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46774|NCT02302716|E2|Reported Event|LANTUS®|Insulin naive participants started on 10 U LANTUS® given SC QD for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or NPH QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46775|NCT02302716|E1|Reported Event|LY2963016|Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or neutral protamine Hagedorn (NPH) QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day (BID) were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
46776|NCT02302365|B1|Baseline|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
46777|NCT02302365|P1|Participant Flow|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
46778|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
46779|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
46780|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
46789|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
46790|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
46791|NCT02302365|E1|Reported Event|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
46792|NCT02302092|B3|Baseline|Total|Total of all reporting groups
46793|NCT02302092|B2|Baseline|Cefepime|Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
46794|NCT02302092|B1|Baseline|Flomoxef|Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
46795|NCT02302092|P2|Participant Flow|Cefepime|Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
46796|NCT02302092|P1|Participant Flow|Flomoxef|Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
46797|NCT02302092|O2|Outcome|Cefepime|Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
46798|NCT02302092|O1|Outcome|Flomoxef|Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
46799|NCT02302092|O2|Outcome|Cefepime|Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
46800|NCT02302092|O1|Outcome|Flomoxef|Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
46801|NCT02302092|O2|Outcome|Cefepime|Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
46802|NCT02302092|O1|Outcome|Flomoxef|Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
46803|NCT02302092|O2|Outcome|Cefepime|Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
46804|NCT02302092|O1|Outcome|Flomoxef|Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
46805|NCT02302092|O2|Outcome|Cefepime|Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
46806|NCT02302092|O1|Outcome|Flomoxef|Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
46807|NCT02302092|O2|Outcome|Cefepime|Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
46808|NCT02302092|O1|Outcome|Flomoxef|Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
46809|NCT02302092|O2|Outcome|Cefepime|Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
46810|NCT02302092|O1|Outcome|Flomoxef|Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
46811|NCT02302092|O2|Outcome|Cefepime|Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
46812|NCT02302092|O1|Outcome|Flomoxef|Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
46813|NCT02302092|O2|Outcome|Cefepime|Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
46814|NCT02302092|O1|Outcome|Flomoxef|Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
46815|NCT02302092|O2|Outcome|Cefepime|Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
46816|NCT02302092|O1|Outcome|Flomoxef|Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
46817|NCT02302092|O2|Outcome|Cefepime|Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
46818|NCT02302092|O1|Outcome|Flomoxef|Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
46819|NCT02302092|E2|Reported Event|Cefepime|Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
46820|NCT02302092|E1|Reported Event|Flomoxef|Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
46821|NCT02301975|B4|Baseline|Total|Total of all reporting groups
46822|NCT02301975|B3|Baseline|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46823|NCT02301975|B2|Baseline|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46824|NCT02301975|B1|Baseline|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46825|NCT02301975|P3|Participant Flow|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46826|NCT02301975|P2|Participant Flow|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46827|NCT02301975|P1|Participant Flow|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46828|NCT02301975|O3|Outcome|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46829|NCT02301975|O2|Outcome|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46902|NCT02301169|B2|Baseline|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
46830|NCT02301975|O1|Outcome|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46831|NCT02301975|O3|Outcome|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46832|NCT02301975|O2|Outcome|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46833|NCT02301975|O1|Outcome|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46834|NCT02301975|O3|Outcome|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46835|NCT02301975|O2|Outcome|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46836|NCT02301975|O1|Outcome|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46837|NCT02301975|O3|Outcome|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46838|NCT02301975|O2|Outcome|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46839|NCT02301975|O1|Outcome|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46840|NCT02301975|O3|Outcome|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46841|NCT02301975|O2|Outcome|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46842|NCT02301975|O1|Outcome|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46843|NCT02301975|O3|Outcome|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46844|NCT02301975|O2|Outcome|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46845|NCT02301975|O1|Outcome|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46846|NCT02301975|O3|Outcome|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46847|NCT02301975|O2|Outcome|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46848|NCT02301975|O1|Outcome|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46849|NCT02301975|E3|Reported Event|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46850|NCT02301975|E2|Reported Event|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46851|NCT02301975|E1|Reported Event|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
46852|NCT02301936|B3|Baseline|Total|Total of all reporting groups
46853|NCT02301936|B2|Baseline|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
46854|NCT02301936|B1|Baseline|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
46855|NCT02301936|P2|Participant Flow|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
47702|NCT02294461|O3|Outcome|M2- N-Desmethyl Enzalutamide|N-desmethyl enzalutamide (active metabolite)
46856|NCT02301936|P1|Participant Flow|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) 90/400 mg fixed dose combination (FDC) tablet once daily for 12 weeks
46857|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
46858|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
46859|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
46860|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
46861|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
46862|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
46863|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
46864|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
46865|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
46866|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
46867|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
46868|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
46869|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
46870|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
46871|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
46872|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
46873|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
46874|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
46875|NCT02301936|E2|Reported Event|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
46876|NCT02301936|E1|Reported Event|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
46877|NCT02301429|B1|Baseline|Model 20105|"Receiving the model 20105 Lead~Model 20105: implant and follow-up of study device"
46878|NCT02301429|P1|Participant Flow|Model 20105|"Receiving the model 20105 Lead~Model 20105: implant and follow-up of study device"
46879|NCT02301429|O1|Outcome|Model 20105|"Receiving the model 20105 Lead~Model 20105: implant and follow-up of study device"
46880|NCT02301429|E1|Reported Event|Model 20105|"Receiving the model 20105 Lead~Model 20105: implant and follow-up of study device"
46881|NCT02301377|B3|Baseline|Total|Total of all reporting groups
46882|NCT02301377|B2|Baseline|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
46883|NCT02301377|B1|Baseline|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
46884|NCT02301377|P2|Participant Flow|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
46885|NCT02301377|P1|Participant Flow|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
46903|NCT02301169|B1|Baseline|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
46886|NCT02301377|O2|Outcome|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
46887|NCT02301377|O1|Outcome|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
46888|NCT02301377|O2|Outcome|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
46889|NCT02301377|O1|Outcome|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
46890|NCT02301377|O2|Outcome|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
46891|NCT02301377|O1|Outcome|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
46892|NCT02301377|E2|Reported Event|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
46893|NCT02301377|E1|Reported Event|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
46894|NCT02301364|B1|Baseline|Buparlisib (BKM120)|This is an open-label, phase II trial of the pan-PI3K inhibitor buparlisib (BKM120) for patients with recurrent or refractory primary central nervous lymphoma (PCNSL) and recurrent or refractory secondary central nervous lymphoma (SCNSL).
46895|NCT02301364|P1|Participant Flow|Buparlisib (BKM120)|This is an open-label, phase II trial of the pan-PI3K inhibitor buparlisib (BKM120) for patients with recurrent or refractory primary central nervous lymphoma (PCNSL) and recurrent or refractory secondary central nervous lymphoma (SCNSL).
46896|NCT02301364|O1|Outcome|Buparlisib (BKM120)|This is an open-label, phase II trial of the pan-PI3K inhibitor buparlisib (BKM120) for patients with recurrent or refractory primary central nervous lymphoma (PCNSL) and recurrent or refractory secondary central nervous lymphoma (SCNSL).
46897|NCT02301364|O1|Outcome|Buparlisib (BKM120)|This is an open-label, phase II trial of the pan-PI3K inhibitor buparlisib (BKM120) for patients with recurrent or refractory primary central nervous lymphoma (PCNSL) and recurrent or refractory secondary central nervous lymphoma (SCNSL).
46898|NCT02301364|O1|Outcome|Buparlisib (BKM120)|This is an open-label, phase II trial of the pan-PI3K inhibitor buparlisib (BKM120) for patients with recurrent or refractory primary central nervous lymphoma (PCNSL) and recurrent or refractory secondary central nervous lymphoma (SCNSL).
46899|NCT02301364|O1|Outcome|Buparlisib (BKM120)|This is an open-label, phase II trial of the pan-PI3K inhibitor buparlisib (BKM120) for patients with recurrent or refractory primary central nervous lymphoma (PCNSL) and recurrent or refractory secondary central nervous lymphoma (SCNSL).
46900|NCT02301364|E1|Reported Event|Buparlisib (BKM120)|This is an open-label, phase II trial of the pan-PI3K inhibitor buparlisib (BKM120) for patients with recurrent or refractory primary central nervous lymphoma (PCNSL) and recurrent or refractory secondary central nervous lymphoma (SCNSL).
46904|NCT02301169|P2|Participant Flow|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
46905|NCT02301169|P1|Participant Flow|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
46906|NCT02301169|O2|Outcome|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
46907|NCT02301169|O1|Outcome|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
46908|NCT02301169|O2|Outcome|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
46909|NCT02301169|O1|Outcome|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
46910|NCT02301169|O2|Outcome|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
46911|NCT02301169|O1|Outcome|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
46912|NCT02301169|O2|Outcome|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
46913|NCT02301169|O1|Outcome|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
46914|NCT02301169|O2|Outcome|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
46915|NCT02301169|O1|Outcome|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
46916|NCT02301169|E2|Reported Event|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
46917|NCT02301169|E1|Reported Event|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
46918|NCT02300558|B1|Baseline|Eleclazine|"Single-Blind Treatment Period: Single oral loading dose of placebo to match eleclazine loading dose (8 x 6 mg placebo to match tablets) on Day 1; eleclazine 48 mg ( 8 x 6 mg tablets) on Day 2; followed by eleclazine 3 mg (1 x 3 mg tablet) once daily from Day 3 to the Week 12 Visit; then once daily maintenance dose of eleclazine 6 mg (1 x 6 mg tablet) from the day after the Week 12 Visit through Week 24~OLE: Eleclazine 6 mg or 3 mg tablets orally once daily"
46919|NCT02300558|P1|Participant Flow|Eleclazine|"Single-Blind Treatment Period: Single oral loading dose of placebo to match eleclazine loading dose (8 x 6 mg placebo to match tablets) on Day 1; eleclazine 48 mg ( 8 x 6 mg tablets) on Day 2; followed by eleclazine 3 mg (1 x 3 mg tablet) once daily from Day 3 to the Week 12 Visit; then once daily maintenance dose of eleclazine 6 mg (1 x 6 mg tablet) from the day after the Week 12 Visit through Week 24~Open-label Extension (OLE): Eleclazine 6 mg or 3 mg tablets orally once daily"
46920|NCT02300558|O1|Outcome|Eleclazine|"Single-Blind Treatment Period: Single oral loading dose of placebo to match eleclazine loading dose (8 x 6 mg placebo to match tablets) on Day 1; eleclazine 48 mg ( 8 x 6 mg tablets) on Day 2; followed by eleclazine 3 mg (1 x 3 mg tablet) once daily from Day 3 to the Week 12 Visit; then once daily maintenance dose of eleclazine 6 mg (1 x 6 mg tablet) from the day after the Week 12 Visit through Week 24~OLE: Eleclazine 6 mg or 3 mg tablets orally once daily"
46921|NCT02300558|O1|Outcome|Eleclazine|"Single-Blind Treatment Period: Single oral loading dose of placebo to match eleclazine loading dose (8 x 6 mg placebo to match tablets) on Day 1; eleclazine 48 mg ( 8 x 6 mg tablets) on Day 2; followed by eleclazine 3 mg (1 x 3 mg tablet) once daily from Day 3 to the Week 12 Visit; then once daily maintenance dose of eleclazine 6 mg (1 x 6 mg tablet) from the day after the Week 12 Visit through Week 24~OLE: Eleclazine 6 mg or 3 mg tablets orally once daily"
46922|NCT02300558|O1|Outcome|Eleclazine|"Single-Blind Treatment Period: Single oral loading dose of placebo to match eleclazine loading dose (8 x 6 mg placebo to match tablets) on Day 1; eleclazine 48 mg ( 8 x 6 mg tablets) on Day 2; followed by eleclazine 3 mg (1 x 3 mg tablet) once daily from Day 3 to the Week 12 Visit; then once daily maintenance dose of eleclazine 6 mg (1 x 6 mg tablet) from the day after the Week 12 Visit through Week 24~OLE: Eleclazine 6 mg or 3 mg tablets orally once daily"
46923|NCT02300558|O1|Outcome|Eleclazine|"Single-Blind Treatment Period: Single oral loading dose of placebo to match eleclazine loading dose (8 x 6 mg placebo to match tablets) on Day 1; eleclazine 48 mg ( 8 x 6 mg tablets) on Day 2; followed by eleclazine 3 mg (1 x 3 mg tablet) once daily from Day 3 to the Week 12 Visit; then once daily maintenance dose of eleclazine 6 mg (1 x 6 mg tablet) from the day after the Week 12 Visit through Week 24~OLE: Eleclazine 6 mg or 3 mg tablets orally once daily"
46924|NCT02300558|E5|Reported Event|All Eleclazine|"Loading Dose: Eleclazine 48 mg ( 8 x 6 mg tablets) administered on Day 2 and 3 mg (1 x 3 mg tablet) once daily from Day 3 to the Week 12 Visit~Maintenance dose: Eleclazine 6 mg (1 x 6 mg tablet) from the day after the Week 12 Visit through Week 24 and open-label extension.~Adverse events in this reporting group include those that occurred any time during the study by participants while receiving loading dose or maintenance dose of eleclazine."
46925|NCT02300558|E4|Reported Event|Eleclazine MD 6 mg|Eleclazine 6 mg (1 x 6 mg tablet) administered orally from the day after the Week 12 Visit through Week 24 and open-label extension.
46926|NCT02300558|E3|Reported Event|Eleclazine Maintenance Dose (MD) 3 mg|Eleclazine 3 mg (1 x 3 mg tablet) administered once daily from Day 3 to the Week 12 Visit
46927|NCT02300558|E2|Reported Event|Eleclazine Loading Dose (LD) 48 mg|Eleclazine 48 mg ( 8 x 6 mg tablets) administered orally on Day 2
46928|NCT02300558|E1|Reported Event|Placebo|Single oral loading dose of placebo to match eleclazine loading dose (8 x 6 mg placebo to match tablets) on Day 1
46929|NCT02300311|B3|Baseline|Total|Total of all reporting groups
46930|NCT02300311|B2|Baseline|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.~Treatment duration consists of up to 4 days."
46952|NCT02300129|E5|Reported Event|Period 2 CD07805/47 0.5% Gel Cross Over|Period 2 CD07805/47 0.5% gel (application on full face) Overall safety population, N=32
46931|NCT02300311|B1|Baseline|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
46932|NCT02300311|P2|Participant Flow|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.~Treatment duration consists of up to 4 days."
46933|NCT02300311|P1|Participant Flow|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
46934|NCT02300311|O2|Outcome|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.~Treatment duration consists of up to 4 days."
46935|NCT02300311|O1|Outcome|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
46936|NCT02300311|O2|Outcome|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.~Treatment duration consists of up to 4 days."
46937|NCT02300311|O1|Outcome|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
46938|NCT02300311|O2|Outcome|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.~Treatment duration consists of up to 4 days."
46939|NCT02300311|O1|Outcome|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
46940|NCT02300311|O2|Outcome|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.~Treatment duration consists of up to 4 days."
46941|NCT02300311|O1|Outcome|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
46942|NCT02300311|E2|Reported Event|Finalgon® Cream (Nicoboxil/ Nonivamide)|Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
46943|NCT02300311|E1|Reported Event|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
46944|NCT02300129|B1|Baseline|All Study Participants (Intent To Treat Population)|One subject was excluded from Intent to Treat (ITT) population because he didn't perform any efficacy assessment during the study so N=33 instead of 34 subjects
46945|NCT02300129|P4|Participant Flow|Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47|"Period 1:~Application of 1g of Placebo Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.~Application of 500mg of CD07805/47 0.5% Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).~Period 2 (cross-over design):~Application of 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks then 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks."
46946|NCT02300129|P3|Participant Flow|CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47|"Period 1:~Application of 1g of CD07805/47 0.5% Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.~Application of 500mg of Placebo Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).~Period 2 (cross-over design):~Application of 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks then 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks."
46947|NCT02300129|P2|Participant Flow|Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo|"Period 1:~Application of 1g of Placebo Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.~Application of 500mg of CD07805/47 0.5% Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).~Period 2 (cross-over design):~Application of 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks then 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks."
46948|NCT02300129|P1|Participant Flow|CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo|"Period 1:~Application of 1g of CD07805/47 0.5% Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.~Application of 500mg of Placebo Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).~Period 2 (cross-over design):~Application of 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks then 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks."
46949|NCT02300129|O2|Outcome|Period 2 Placebo Gel Cross-over|CD07805/47 placebo gel
46950|NCT02300129|O1|Outcome|Period 2 CD07805/47 0.5% Gel Cross-over|CD07805/47 0.5% gel (Brimonidine tartrate)
46951|NCT02300129|E6|Reported Event|Period 2 Placebo Gel Cross Over|Period 2 Placebo gel cross over (application on full face) Overall safety population, N=31
46953|NCT02300129|E4|Reported Event|Period 1 CD07805/47 0.5% Gel Cross-over|Period 1 CD07805/47 0.5% cross over (application on full face) Overall safety population, N=33
46954|NCT02300129|E3|Reported Event|Period 1 Placebo Gel Split Face|Period 1 Placebo gel split face (application on one side of face) Overall safety population, N=33
46955|NCT02300129|E2|Reported Event|Period 1 CD07805/47 0.5% Gel Split Face|Period 1 CD07805/47 0.5% gel split face (application on one side of face) Overall safety population, N=33
46956|NCT02300129|E1|Reported Event|Period 1 Placebo Gel Cross Over|Period 1 Placebo gel cross over (application on full face) Overall safety population, N=34
46957|NCT02300103|B1|Baseline|SOF/VEL+RBV|SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
46958|NCT02300103|P1|Participant Flow|SOF/VEL+RBV|Sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) (400/100mg) fixed-dose combination (FDC) tablet once daily + ribavirin (RBV) tablets (1000 mg or 1200 mg) for 24 weeks
46959|NCT02300103|O1|Outcome|SOF/VEL+RBV|SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
46960|NCT02300103|O1|Outcome|SOF/VEL+RBV|SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
46961|NCT02300103|O1|Outcome|SOF/VEL+RBV|SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
46962|NCT02300103|O1|Outcome|SOF/VEL+RBV|SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
46963|NCT02300103|O1|Outcome|SOF/VEL+RBV|SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
46964|NCT02300103|O1|Outcome|SOF/VEL+RBV|SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
46965|NCT02300103|E1|Reported Event|SOF/VEL+RBV|SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
46966|NCT02300025|B5|Baseline|Total|Total of all reporting groups
46967|NCT02300025|B4|Baseline|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class c, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46968|NCT02300025|B3|Baseline|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46969|NCT02300025|B2|Baseline|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46970|NCT02300025|B1|Baseline|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46971|NCT02300025|P4|Participant Flow|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46972|NCT02300025|P3|Participant Flow|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46973|NCT02300025|P2|Participant Flow|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46974|NCT02300025|P1|Participant Flow|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 milligrams (mg) cobimetinib (two 5 mg capsules) on Day 1 of study.
46975|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46976|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46977|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46978|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46979|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46980|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46981|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46982|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46983|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46984|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46985|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46986|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46987|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
47703|NCT02294461|O2|Outcome|M1- Carboxylic Acid Metabolite|Inactive metabolite
46988|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46989|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46990|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46991|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46992|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46993|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46994|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46995|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46996|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46997|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46998|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
46999|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
47000|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
47001|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
47002|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
47003|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
47004|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
47005|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
47006|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
47007|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
47008|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
47009|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
47010|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
47011|NCT02300025|E4|Reported Event|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class A, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
47012|NCT02300025|E3|Reported Event|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
47013|NCT02300025|E2|Reported Event|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
47014|NCT02300025|E1|Reported Event|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
47015|NCT02299869|B5|Baseline|Total|Total of all reporting groups
47016|NCT02299869|B4|Baseline|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47017|NCT02299869|B3|Baseline|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47018|NCT02299869|B2|Baseline|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47019|NCT02299869|B1|Baseline|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
68278|NCT02151461|O4|Outcome|Control|Day 1-14: 500mg, Day 15-28: 850mg
47020|NCT02299869|P4|Participant Flow|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47021|NCT02299869|P3|Participant Flow|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47022|NCT02299869|P2|Participant Flow|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47023|NCT02299869|P1|Participant Flow|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47024|NCT02299869|O4|Outcome|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47025|NCT02299869|O3|Outcome|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47026|NCT02299869|O2|Outcome|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47027|NCT02299869|O1|Outcome|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47028|NCT02299869|O4|Outcome|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47029|NCT02299869|O3|Outcome|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47030|NCT02299869|O2|Outcome|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47031|NCT02299869|O1|Outcome|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47032|NCT02299869|O4|Outcome|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47033|NCT02299869|O3|Outcome|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47034|NCT02299869|O2|Outcome|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47035|NCT02299869|O1|Outcome|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47036|NCT02299869|O4|Outcome|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47037|NCT02299869|O3|Outcome|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47038|NCT02299869|O2|Outcome|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47039|NCT02299869|O1|Outcome|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47040|NCT02299869|O4|Outcome|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47041|NCT02299869|O3|Outcome|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47042|NCT02299869|O2|Outcome|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47043|NCT02299869|O1|Outcome|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
47044|NCT02299869|E1|Reported Event|Overall Participants|Each subject was randomized to wear the test and control lenses in a series of four short fitting comparisons (pair 1, pair 2, pair 3, and pair 4).
47045|NCT02299791|B3|Baseline|Total|Total of all reporting groups
47046|NCT02299791|B2|Baseline|Late Implementation|"5 study clinics received the ALL intervention starting 6/1/12~ALL: These clinics got the same exact intervention, but one year later, as this was a staggered randomized trial."
47047|NCT02299791|B1|Baseline|Early Intervention|"6 study clinics received the ALL intervention starting 6/1/11~ALL: This clinic-level intervention involves a toolkit of decision support tools. These tools are listed below.~EHR tools to expedite identification~a. EHR automated point-of-care alerts (Best Practice Alerts)~EHR tools to expedite prescribing~EHR order sets~EHR text shortcuts for notation~patient education materials (handout, poster)~EHR-based outreach support tools a. EHR registries"
47048|NCT02299791|P2|Participant Flow|Late Interventions Number of Patients|"5 study clinics received the ALL intervention starting 6/1/12~ALL: These clinics got the same exact intervention, but one year later, as this was a staggered randomized trial."
47049|NCT02299791|P1|Participant Flow|Early Intervention Number of Patients|"Patients in 6 study clinics received the ALL intervention starting 6/1/11~ALL: This clinic-level intervention involves a toolkit of decision support tools. These tools are listed below.~EHR tools to expedite identification~a. EHR automated point-of-care alerts (Best Practice Alerts)~EHR tools to expedite prescribing~EHR order sets~EHR text shortcuts for notation~patient education materials (handout, poster)~EHR-based outreach support tools a. EHR registries"
47050|NCT02299791|O2|Outcome|Late Implementation|"5 study clinics received the ALL intervention starting 6/1/12~ALL: These clinics got the same exact intervention, but one year later, as this was a staggered randomized trial."
47051|NCT02299791|O1|Outcome|Early Intervention|"6 study clinics received the ALL intervention starting 6/1/11~ALL: This clinic-level intervention involves a toolkit of decision support tools. These tools are listed below.~EHR tools to expedite identification~a. EHR automated point-of-care alerts (Best Practice Alerts)~EHR tools to expedite prescribing~EHR order sets~EHR text shortcuts for notation~patient education materials (handout, poster)~EHR-based outreach support tools a. EHR registries"
47052|NCT02299791|E2|Reported Event|Late Implementation|"5 study clinics received the ALL intervention starting 6/1/12~ALL: These clinics got the same exact intervention, but one year later, as this was a staggered randomized trial."
47077|NCT02299427|P1|Participant Flow|Dog Safety|"2 weeks of regular use of website on child dog safety developed for this research~dog safety: use of dog safety website at home for about 2 weeks"
68279|NCT02151461|O3|Outcome|FDC500|Leucine 1100mg +Metformin 500mg
47053|NCT02299791|E1|Reported Event|Early Intervention|"6 study clinics received the ALL intervention starting 6/1/11~ALL: This clinic-level intervention involves a toolkit of decision support tools. These tools are listed below.~EHR tools to expedite identification~a. EHR automated point-of-care alerts (Best Practice Alerts)~EHR tools to expedite prescribing~EHR order sets~EHR text shortcuts for notation~patient education materials (handout, poster)~EHR-based outreach support tools a. EHR registries"
47054|NCT02299635|B1|Baseline|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
47055|NCT02299635|P1|Participant Flow|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
47056|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
47057|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
47058|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
47059|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
47060|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
47061|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
47062|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
47063|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
47064|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
47065|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
47066|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
47067|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
47068|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
47069|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
47070|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
47071|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
47072|NCT02299635|E1|Reported Event|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
47073|NCT02299427|B3|Baseline|Total|Total of all reporting groups
47074|NCT02299427|B2|Baseline|Transportation Safety|"2 weeks of regular use of publicly-available website on child transportation safety~transportation safety: use of transportation safety website at home for about 2 weeks"
47075|NCT02299427|B1|Baseline|Dog Safety|"2 weeks of regular use of website on child dog safety developed for this research~dog safety: use of dog safety website at home for about 2 weeks"
47076|NCT02299427|P2|Participant Flow|Transportation Safety|"2 weeks of regular use of publicly-available website on child transportation safety~transportation safety: use of transportation safety website at home for about 2 weeks"
47078|NCT02299427|O2|Outcome|Transportation Safety|"2 weeks of regular use of publicly-available website on child transportation safety~transportation safety: use of transportation safety website at home for about 2 weeks"
47079|NCT02299427|O1|Outcome|Dog Safety|"2 weeks of regular use of website on child dog safety developed for this research~dog safety: use of dog safety website at home for about 2 weeks"
47080|NCT02299427|O2|Outcome|Transportation Safety|"2 weeks of regular use of publicly-available website on child transportation safety~transportation safety: use of transportation safety website at home for about 2 weeks"
47081|NCT02299427|O1|Outcome|Dog Safety|"2 weeks of regular use of website on child dog safety developed for this research~dog safety: use of dog safety website at home for about 2 weeks"
47082|NCT02299427|E2|Reported Event|Transportation Safety|"2 weeks of regular use of publicly-available website on child transportation safety~transportation safety: use of transportation safety website at home for about 2 weeks"
47083|NCT02299427|E1|Reported Event|Dog Safety|"2 weeks of regular use of website on child dog safety developed for this research~dog safety: use of dog safety website at home for about 2 weeks~There is a discrepancy in participants at risk compared to the participant flow module because some children were not compliant to the intervention. They did not use the internet website and therefore were excluded from analyses. They did not have adverse events; they merely were not exposed to the intervention and therefore were excluded from analysis."
47084|NCT02299349|B3|Baseline|Total|Total of all reporting groups
47085|NCT02299349|B2|Baseline|Concentrated Multi Drug Injection|"concentrated multi drug periarticular injection~concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl"
47086|NCT02299349|B1|Baseline|Bupivacaine Liposome Suspension|"bupivacaine liposome suspension periarticular injection~bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection"
47087|NCT02299349|P2|Participant Flow|Concentrated Multi Drug Injection|"concentrated multi drug periarticular injection~concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl"
47088|NCT02299349|P1|Participant Flow|Bupivacaine Liposome Suspension|"bupivacaine liposome suspension periarticular injection~bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection"
47089|NCT02299349|O2|Outcome|Concentrated Multi Drug Injection|"concentrated multi drug periarticular injection~concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl"
47090|NCT02299349|O1|Outcome|Bupivacaine Liposome Suspension|"bupivacaine liposome suspension periarticular injection~bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection"
47091|NCT02299349|O2|Outcome|Concentrated Multi Drug Injection|"concentrated multi drug periarticular injection~concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl"
47092|NCT02299349|O1|Outcome|Bupivacaine Liposome Suspension|"bupivacaine liposome suspension periarticular injection~bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection"
47093|NCT02299349|E2|Reported Event|Concentrated Multi Drug Injection|"concentrated multi drug periarticular injection~concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl"
47094|NCT02299349|E1|Reported Event|Bupivacaine Liposome Suspension|"bupivacaine liposome suspension periarticular injection~bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection"
47095|NCT02299258|B3|Baseline|Total|Total of all reporting groups
47096|NCT02299258|B2|Baseline|Standard Stents MTN-CG-s-20/100|"Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm~Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm"
47097|NCT02299258|B1|Baseline|Tailored Stents MTN-WE-20/100-A|"The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.~Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs."
47098|NCT02299258|P2|Participant Flow|Standard Stents MTN-CG-s-20/100|"Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm~Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm"
47099|NCT02299258|P1|Participant Flow|Tailored Stents MTN-WE-20/100-A|"The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.~Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs."
47100|NCT02299258|O2|Outcome|Standard Stents MTN-CG-s-20/100|"Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm~Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm"
47101|NCT02299258|O1|Outcome|Tailored Stents MTN-WE-20/100-A|"The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.~Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs."
47117|NCT02299089|B2|Baseline|CAM2029 20 mg q4w (Acromegaly)|"CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly~octreotide FluidCrystal® injection depot"
47102|NCT02299258|O2|Outcome|Standard Stents MTN-CG-s-20/100|"Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm~Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm"
47103|NCT02299258|O1|Outcome|Tailored Stents MTN-WE-20/100-A|"The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.~Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs."
47104|NCT02299258|E2|Reported Event|Standard Stents MTN-CG-s-20/100|"Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm~Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm"
47105|NCT02299258|E1|Reported Event|Tailored Stents MTN-WE-20/100-A|"The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.~Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs."
47106|NCT02299206|B1|Baseline|CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina|"Healthy 3-18 months old infants with mild to moderate diaper dermatitis.~CeraVe Baby Diaper Rash Cream: Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) or Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period."
47107|NCT02299206|P1|Participant Flow|CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina|"Healthy 3-18 months old infants with mild to moderate diaper dermatitis.~CeraVe Baby Diaper Rash Cream: Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) or Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period."
47108|NCT02299206|O1|Outcome|CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina|"Healthy 3-18 months old infants with mild to moderate diaper dermatitis.~CeraVe Baby Diaper Rash Cream: Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) or Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period."
47109|NCT02299206|O1|Outcome|CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina|"Healthy 3-18 months old infants with mild to moderate diaper dermatitis.~CeraVe Baby Diaper Rash Cream: Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) or Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period."
47110|NCT02299206|O1|Outcome|CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina|"Healthy 3-18 months old infants with mild to moderate diaper dermatitis.~CeraVe Baby Diaper Rash Cream: Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) or Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period."
47111|NCT02299206|O1|Outcome|CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina|"Healthy 3-18 months old infants with mild to moderate diaper dermatitis.~CeraVe Baby Diaper Rash Cream: Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) or Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period."
47112|NCT02299206|O1|Outcome|CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina|"Healthy 3-18 months old infants with mild to moderate diaper dermatitis.~CeraVe Baby Diaper Rash Cream: Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) or Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period."
47113|NCT02299206|E1|Reported Event|CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina|"Healthy 3-18 months old infants with mild to moderate diaper dermatitis.~CeraVe Baby Diaper Rash Cream: Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) or Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period.~Arms are combined for reporting of adverse events. Due to the low number of subjects, data will not be analyzed and the arm assignment for the subjects was not determined."
47114|NCT02299089|B5|Baseline|Total|Total of all reporting groups
47115|NCT02299089|B4|Baseline|CAM2029 20 mg q4w (NET)|"CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly~octreotide FluidCrystal® injection depot"
47116|NCT02299089|B3|Baseline|CAM2029 10 mg q2w (NET)|"CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks~octreotide FluidCrystal® injection depot"
47505|NCT02295020|O1|Outcome|Standard Treatment Only.|Standard treatment only such as NSAIDs and injections.
47118|NCT02299089|B1|Baseline|CAM2029 10 mg q2w (Acromegaly)|"CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks~octreotide FluidCrystal® injection depot"
47119|NCT02299089|P4|Participant Flow|CAM2029 20 mg q4w (NET)|"CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly~octreotide FluidCrystal® injection depot"
47120|NCT02299089|P3|Participant Flow|CAM2029 10 mg q2w (NET)|"CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks~octreotide FluidCrystal® injection depot"
47121|NCT02299089|P2|Participant Flow|CAM2029 20 mg q4w (Acromegaly)|"CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly~octreotide FluidCrystal® injection depot"
47122|NCT02299089|P1|Participant Flow|CAM2029 10 mg q2w (Acromegaly)|"CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks~octreotide FluidCrystal® injection depot"
47123|NCT02299089|O2|Outcome|CAM2029 20 mg q4w (NET)|"CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly~octreotide FluidCrystal® injection depot"
47124|NCT02299089|O1|Outcome|CAM2029 10 mg q2w (NET)|"CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks~octreotide FluidCrystal® injection depot"
47125|NCT02299089|O2|Outcome|CAM2029 20 mg q4w (Acromegaly)|"CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly~octreotide FluidCrystal® injection depot"
47126|NCT02299089|O1|Outcome|CAM2029 10 mg q2w (Acromegaly)|"CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks~octreotide FluidCrystal® injection depot"
47127|NCT02299089|O2|Outcome|CAM2029 20 mg q4w (Acromegaly)|"CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly~octreotide FluidCrystal® injection depot"
47128|NCT02299089|O1|Outcome|CAM2029 10 mg q2w (Acromegaly)|"CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks~octreotide FluidCrystal® injection depot"
47129|NCT02299089|O6|Outcome|Sandostain LAR (NET)|Period day-28 to 0 All NET patient and all treatment groups
47130|NCT02299089|O5|Outcome|Sandostatin LAR (Acromegaly)|Period day -28 to day 0 All acromegaly patients and all treatment groups
47131|NCT02299089|O4|Outcome|CAM2029 20 mg q4w (NET)|"CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly~octreotide FluidCrystal® injection depot"
47132|NCT02299089|O3|Outcome|CAM2029 10 mg q2w (NET)|"CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks~octreotide FluidCrystal® injection depot"
47133|NCT02299089|O2|Outcome|CAM2029 20 mg q4w (Acromegaly)|"CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly~octreotide FluidCrystal® injection depot"
47134|NCT02299089|O1|Outcome|CAM2029 10 mg q2w (Acromegaly)|"CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks~octreotide FluidCrystal® injection depot"
47135|NCT02299089|O4|Outcome|CAM2029 20 mg q4w (NET)|"CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly~octreotide FluidCrystal® injection depot"
47136|NCT02299089|O3|Outcome|CAM2029 10 mg q2w (NET)|"CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks~octreotide FluidCrystal® injection depot"
47137|NCT02299089|O2|Outcome|CAM2029 20 mg q4w (Acromegaly)|"CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly~octreotide FluidCrystal® injection depot"
47138|NCT02299089|O1|Outcome|CAM2029 10 mg q2w (Acromegaly)|"CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks~octreotide FluidCrystal® injection depot"
47139|NCT02299089|O4|Outcome|CAM2029 20 mg q4w (NET)|"CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly~octreotide FluidCrystal® injection depot"
47140|NCT02299089|O3|Outcome|CAM2029 10 mg q2w (NET)|"CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks~octreotide FluidCrystal® injection depot"
47141|NCT02299089|O2|Outcome|CAM2029 20 mg q4w (Acromegaly)|"CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly~octreotide FluidCrystal® injection depot"
47142|NCT02299089|O1|Outcome|CAM2029 10 mg q2w (Acromegaly)|"CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks~octreotide FluidCrystal® injection depot"
47143|NCT02299089|O4|Outcome|Sandostatin LAR 30 mg (NET)|Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
47144|NCT02299089|O3|Outcome|Sandostatin LAR 20 mg (NET)|Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
47145|NCT02299089|O2|Outcome|Sandostatin LAR 30mg (Acromegaly)|Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
47146|NCT02299089|O1|Outcome|Sandostatin LAR 10 mg (Acromegaly)|Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
47147|NCT02299089|O4|Outcome|Sandostatin LAR 30 mg (NET)|Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
47148|NCT02299089|O3|Outcome|Sandostatin LAR 20 mg (NET)|Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
47149|NCT02299089|O2|Outcome|Sandostatin LAR 30mg (Acromegaly)|Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
47150|NCT02299089|O1|Outcome|Sandostatin LAR 10 mg (Acromegaly)|Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
47151|NCT02299089|O4|Outcome|CAM2029 20 mg q4w (NET)|"CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly~octreotide FluidCrystal® injection depot"
47152|NCT02299089|O3|Outcome|CAM2029 10 mg q2w (NET)|"CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks~octreotide FluidCrystal® injection depot"
47153|NCT02299089|O2|Outcome|CAM2029 20 mg q4w (Acromegaly)|"CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly~octreotide FluidCrystal® injection depot"
47657|NCT02294474|O1|Outcome|SAR342434|SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
47154|NCT02299089|O1|Outcome|CAM2029 10 mg q2w (Acromegaly)|"CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks~octreotide FluidCrystal® injection depot"
47155|NCT02299089|O4|Outcome|Sandostatin LAR 30 mg (NET)|Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
47156|NCT02299089|O3|Outcome|Sandostatin LAR 20 mg (NET)|Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
47157|NCT02299089|O2|Outcome|Sandostatin LAR 30mg (Acromegaly)|Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
47158|NCT02299089|O1|Outcome|Sandostatin LAR 10 mg (Acromegaly)|Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
47159|NCT02299089|E6|Reported Event|Sandostatin LAR (NET)|Sandostatin LAR Day -28 to day 0 All NET patients, all treatment groups
47160|NCT02299089|E5|Reported Event|Sandostatin LAR (Acromegaly)|Sandostatin LAR Day-28 to day 0 All acromegaly patients, all treatment groups
47161|NCT02299089|E4|Reported Event|CAM2029 20 mg q4w (NET)|"CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly~octreotide FluidCrystal® injection depot Day 0-84"
47162|NCT02299089|E3|Reported Event|CAM2029 10 mg q2w (NET)|"CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks~octreotide FluidCrystal® injection depot Day 0-84"
47163|NCT02299089|E2|Reported Event|CAM2029 20 mg q4w (Acormegaly)|"CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly~octreotide FluidCrystal® injection depot Day 0-84"
47164|NCT02299089|E1|Reported Event|CAM2029 10 mg q2w (Acromegaly)|"CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks~octreotide FluidCrystal® injection depot Day 0-84"
47165|NCT02299076|B3|Baseline|Total|Total of all reporting groups
47166|NCT02299076|B2|Baseline|Usual Care With BE Incentives|"Participants in this arm receive usual care from the Pro-Change smoking cessation program, the chance to win money based on their behavior (Behavioral economics incentives), and receive compensation for enrolling and completing a survey at the end of the study.~Behavioral economics incentives: Behavioral economics-informed incentives to promote engagement and outcomes in a smoking cessation intervention."
47167|NCT02299076|B1|Baseline|Usual Care With Minimal Incentives|"Participants in this arm receive usual care from the Pro-Change smoking cessation program, and receive compensation for enrolling and completing a survey at the end of the study.~Minimal incentives: Minimal financial incentives to promote engagement, and outcomes in a smoking cessation intervention."
47168|NCT02299076|P2|Participant Flow|Usual Care With BE Incentives|"Participants in this arm receive usual care from the Pro-Change smoking cessation program, the chance to win money based on their behavior (Behavioral economics incentives), and receive compensation for enrolling and completing a survey at the end of the study.~Behavioral economics incentives: Behavioral economics-informed incentives to promote engagement and outcomes in a smoking cessation intervention."
47169|NCT02299076|P1|Participant Flow|Usual Care With Minimal Incentives|"Participants in this arm receive usual care from the Pro-Change smoking cessation program, and receive compensation for enrolling and completing a survey at the end of the study.~Minimal incentives: Minimal financial incentives to promote engagement, and outcomes in a smoking cessation intervention."
47170|NCT02299076|O2|Outcome|Usual Care With BE Incentives|"Participants in this arm receive usual care from the Pro-Change smoking cessation program, the chance to win money based on their behavior (Behavioral economics incentives), and receive compensation for enrolling and completing a survey at the end of the study.~Behavioral economics incentives: Behavioral economics-informed incentives to promote engagement and outcomes in a smoking cessation intervention."
47171|NCT02299076|O1|Outcome|Usual Care With Minimal Incentives|"Participants in this arm receive usual care from the Pro-Change smoking cessation program, and receive compensation for enrolling and completing a survey at the end of the study.~Minimal incentives: Minimal financial incentives to promote engagement, and outcomes in a smoking cessation intervention."
47172|NCT02299076|O2|Outcome|Usual Care With BE Incentives|"Participants in this arm receive usual care from the Pro-Change smoking cessation program, the chance to win money based on their behavior (Behavioral economics incentives), and receive compensation for enrolling and completing a survey at the end of the study.~Behavioral economics incentives: Behavioral economics-informed incentives to promote engagement and outcomes in a smoking cessation intervention."
47173|NCT02299076|O1|Outcome|Usual Care With Minimal Incentives|"Participants in this arm receive usual care from the Pro-Change smoking cessation program, and receive compensation for enrolling and completing a survey at the end of the study.~Minimal incentives: Minimal financial incentives to promote engagement, and outcomes in a smoking cessation intervention."
47174|NCT02299076|E2|Reported Event|Usual Care With BE Incentives|"Participants in this arm receive usual care from the Pro-Change smoking cessation program, the chance to win money based on their behavior (Behavioral economics incentives), and receive compensation for enrolling and completing a survey at the end of the study.~Behavioral economics incentives: Behavioral economics-informed incentives to promote engagement and outcomes in a smoking cessation intervention."
47175|NCT02299076|E1|Reported Event|Usual Care With Minimal Incentives|"Participants in this arm receive usual care from the Pro-Change smoking cessation program, and receive compensation for enrolling and completing a survey at the end of the study.~Minimal incentives: Minimal financial incentives to promote engagement, and outcomes in a smoking cessation intervention."
47176|NCT02298868|B1|Baseline|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
47177|NCT02298868|P1|Participant Flow|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
47178|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
47658|NCT02294474|O2|Outcome|Humalog|Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
47179|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
47180|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
47181|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
47182|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
47183|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
47184|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
47185|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
47186|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
47187|NCT02298868|E1|Reported Event|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
47188|NCT02298842|B3|Baseline|Total|Total of all reporting groups
47189|NCT02298842|B2|Baseline|Plasma First, Then InterSol|Platelets collected in plasma, then platelets collected in InterSol
47190|NCT02298842|B1|Baseline|InterSol First, Then Plasma|Platelets collected in InterSol, then platelets collected in plasma
47191|NCT02298842|P2|Participant Flow|Plasma First, Then InterSol|Platelets collected in plasma, then platelets collected in InterSol
47192|NCT02298842|P1|Participant Flow|InterSol First, Then Plasma|Platelets collected in InterSol, then platelets collected in plasma
47193|NCT02298842|O2|Outcome|Control Platelets Collected and Stored in Plasma|"Platelets stored in Plasma~Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
47194|NCT02298842|O1|Outcome|Test Platelets Collected and Stored in InterSol|"Platelets stored in InterSol~Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
47195|NCT02298842|O2|Outcome|Control Platelets Collected and Stored in Plasma|"Platelets stored in Plasma~Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
47196|NCT02298842|O1|Outcome|Test Platelets Collected and Stored in InterSol|"Platelets stored in InterSol~Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
47197|NCT02298842|O2|Outcome|Control Platelets Collected and Stored in Plasma|"Platelets stored in Plasma~Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
47277|NCT02297815|O2|Outcome|Non-narrow Spectrum Antibiotic|Children diagnosed with an ARTI and prescribed a non-narrow spectrum antibiotic
47198|NCT02298842|O1|Outcome|Test Platelets Collected and Stored in InterSol|"Platelets stored in InterSol~Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
47199|NCT02298842|O2|Outcome|Control Platelets Collected and Stored in Plasma|"Platelets stored in Plasma~Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
47200|NCT02298842|O1|Outcome|Test Platelets Collected and Stored in InterSol|"Platelets stored in InterSol~Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
47201|NCT02298842|O2|Outcome|Control Platelets Collected and Stored in Plasma|"Platelets stored in Plasma~Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
47202|NCT02298842|O1|Outcome|Test Platelets Collected and Stored in InterSol|"Platelets stored in InterSol~Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
47203|NCT02298842|O2|Outcome|Control Platelets Collected and Stored in Plasma|"Platelets stored in Plasma~Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
47204|NCT02298842|O1|Outcome|Test Platelets Collected and Stored in InterSol|"Platelets stored in InterSol~Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
47205|NCT02298842|O2|Outcome|Arm B - Platelets Stored in Plasma|"Platelets stored in Plasma~Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
47206|NCT02298842|O1|Outcome|Arm A - Test Platelets Stored in InterSol|"Platelets stored in InterSol~Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
47278|NCT02297815|O1|Outcome|Narrow Spectrum Antibiotic|Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic
47279|NCT02297815|E2|Reported Event|Non-narrow Spectrum Antibiotic|Children diagnosed with an ARTI and prescribed a non-narrow spectrum antibiotic
68280|NCT02151461|O2|Outcome|FDC250|Leucine 1100mg +Metformin 250mg
47207|NCT02298842|O2|Outcome|Control Platelets Collected and Stored in Plasma|"Platelets stored in Plasma~Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
47208|NCT02298842|O1|Outcome|Test Platelets Collected and Stored in InterSol|"Platelets stored in InterSol~Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
47209|NCT02298842|O2|Outcome|Control Platelets Collected and Stored in Plasma|"Platelets stored in Plasma~Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
47210|NCT02298842|O1|Outcome|Test Platelets Collected and Stored in InterSol|"Platelets stored in InterSol~Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
47211|NCT02298842|O2|Outcome|Control Platelets Collected and Stored in Plasma|"Platelets stored in Plasma~Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
47212|NCT02298842|O1|Outcome|Test Platelets Collected and Stored in InterSol|"Platelets stored in InterSol~Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
47213|NCT02298842|E2|Reported Event|Control Platelets Collected and Stored in Plasma|"Platelets stored in Plasma~Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
47214|NCT02298842|E1|Reported Event|Test Platelets Collected and Stored in InterSol|"Platelets stored in InterSol~Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
47215|NCT02298803|B3|Baseline|Total|Total of all reporting groups
47216|NCT02298803|B2|Baseline|Normoglycemic Group|N=21; these participants experienced no episodes of hypoglycaemia during the monitoring period.
47217|NCT02298803|B1|Baseline|Hypoglycemic Group|N=9; these participants experienced at least one episode of hypoglycaemia (blood glucose level <3.5mmol/L) during the monitoring period.
47280|NCT02297815|E1|Reported Event|Narrow Spectrum Antibiotic|Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic
47281|NCT02297308|B1|Baseline|SoloPath Sheath|The study focuses on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascualar access
47282|NCT02297308|P1|Participant Flow|SoloPath Sheath|The study focused on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascular access.
47283|NCT02297308|O1|Outcome|SoloPath Sheath|Rate of VARC-2 defined access site bleeding complications.
47284|NCT02297308|O1|Outcome|SoloPath Sheath|Vascular Complications
47218|NCT02298803|P1|Participant Flow|Holter and Glucose Monitoring|"In this study all participants underwent simultaneous monitoring of glucose and QT interval via a subcutaneous continuous glucose monitor and a Hoter monitor, respectively.~Holter and Glucose monitoring: (i) Continuous Glucose Monitoring A sterile disposable glucose-sensing sensor was inserted into the subcutaneous tissue in the abdomen of the patient. This sensor automatically measured the average glucose concentration in interstitial fluid every 5 minutes. The monitor was worn for 48 hours.~(ii)Holter Monitoring The Holter monitor was worn for the same period as the continuous glucose monitor. QT intervals were extracted using proprietary software. Study participants were encouraged to perform regular daily activities during monitoring."
47219|NCT02298803|O1|Outcome|Hypoglycemia Group|Those eight participants who experienced hypoglycemia (a Blood Glucose Level <3.5 mmol/L) for a minimum of 20 consecutive minutes during the nocturnal time period (2300-0700) are included in the Hypoglycemia Group for this analysis. The results for deltaQTc for each of the eight participants who experienced hypoglycemia are documented below.
47220|NCT02298803|O1|Outcome|Hypoglycemia Group|Those eight participants who experienced hypoglycemia (a Blood Glucose Level <3.5 mmol/L) for a minimum of 20 consecutive minutes during the nocturnal time period (2300-0700) are included in the Hypoglycemia Group for this analysis. The MAGE results for each of the eight participants who experienced hypoglycemia are documented below.
47221|NCT02298803|O1|Outcome|Hypoglycemia Group|Those eight participants who experienced hypoglycemia (a Blood Glucose Level <3.5 mmol/L) for a minimum of 20 consecutive minutes during the nocturnal time period (2300-0700) are included in the Hypoglycemia Group for this analysis.
47222|NCT02298803|O1|Outcome|Hypoglycemia Group|While there were nine study participants who experienced hypoglycemia during the entire study period, only three of those participants experienced hypoglycemia during the day time period (0700-2300). One study participant experienced isolated day time hypoglycemia; two study participants experienced both nocturnal and day time hypoglycemia. Hypoglycemia during monitoring was defined as a blood glucose level <3.5mmol/L that was sustained for a minimum of 20 consecutive minutes.
47223|NCT02298803|O1|Outcome|Hypoglycemia Group|While there were nine study participants who experienced hypoglycemia during the entire study period, only eight of those participants experienced hypoglycemia during the nocturnal time period (2300-0700). Six study participants experienced isolated nocturnal hypoglycemia; two study participants experienced both nocturnal and day time hypoglycemia. Hypoglycemia during monitoring was defined as a blood glucose level <3.5mmol/L that was sustained for a minimum of 20 consecutive minutes.
47224|NCT02298803|E2|Reported Event|Normoglycemic Group|N=21; these participants experienced no episodes of hypoglycaemia during the monitoring period.
47225|NCT02298803|E1|Reported Event|Hypoglycemic Group|N=9; these participants experienced at least one episode of hypoglycaemia (blood glucose level <3.5mmol/L) during the monitoring period.
47226|NCT02298361|B4|Baseline|Total|Total of all reporting groups
47227|NCT02298361|B3|Baseline|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
47228|NCT02298361|B2|Baseline|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
47229|NCT02298361|B1|Baseline|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
47230|NCT02298361|P3|Participant Flow|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
47231|NCT02298361|P2|Participant Flow|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
47232|NCT02298361|P1|Participant Flow|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
47233|NCT02298361|O3|Outcome|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
47234|NCT02298361|O2|Outcome|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
47235|NCT02298361|O1|Outcome|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
47236|NCT02298361|O3|Outcome|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
47237|NCT02298361|O2|Outcome|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
47238|NCT02298361|O1|Outcome|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
47239|NCT02298361|O3|Outcome|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
47240|NCT02298361|O2|Outcome|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
47241|NCT02298361|O1|Outcome|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
47242|NCT02298361|E3|Reported Event|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
47243|NCT02298361|E2|Reported Event|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
47244|NCT02298361|E1|Reported Event|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
47245|NCT02298192|B3|Baseline|Total|Total of all reporting groups
47285|NCT02297308|E1|Reported Event|SoloPath Sheath|The study focused on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascular access.
47286|NCT02297230|B5|Baseline|Total|Total of all reporting groups
47368|NCT02296476|O2|Outcome|MK-8628 120 mg|Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47369|NCT02296476|O1|Outcome|MK-8628 80 mg|Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47246|NCT02298192|B2|Baseline|IDegLira|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
47247|NCT02298192|B1|Baseline|IDegLira (1WT)|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
47248|NCT02298192|P2|Participant Flow|IDegLira|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
47249|NCT02298192|P1|Participant Flow|IDegLira (1WT)|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
47250|NCT02298192|O2|Outcome|IDegLira|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
47251|NCT02298192|O1|Outcome|IDegLira (1WT)|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
47252|NCT02298192|O2|Outcome|IDegLira|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
47253|NCT02298192|O1|Outcome|IDegLira (1WT)|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
47254|NCT02298192|O2|Outcome|IDegLira|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
47361|NCT02296476|O3|Outcome|MK-8628 160 mg|Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47362|NCT02296476|O2|Outcome|MK-8628 120 mg|Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47255|NCT02298192|O1|Outcome|IDegLira (1WT)|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
47256|NCT02298192|O2|Outcome|IDegLira|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
47257|NCT02298192|O1|Outcome|IDegLira (1WT)|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
47258|NCT02298192|E2|Reported Event|IDegLira|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
47259|NCT02298192|E1|Reported Event|IDegLira (1WT)|Subjects received IDegLira once weekly in combination with metformin alone or in combination with pioglitazone in a 1:1 manner at visit 2 and were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), and the maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).The daily dose for metformin (≥1500 mg or max tolerated dose) and pioglitazone (≥30 mg) The dose of IDegLira was to be adjusted once weekly based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on the titration day. The first dose of trial product was to be administered either on the day of randomisation (visit 2) or the day after.
47260|NCT02297841|B1|Baseline|HRIPT|Novel lubricant Miami w/ fragrance Novel lubricant Miami w/o fragrance 510(k) cleared and currently marketed personal lubricant 510(k) cleared and currently marketed personal lubricant
47261|NCT02297841|P1|Participant Flow|Human Repeat Insult Patch Test|"Experimental: Human Repeat Insult Patch Test~Approximately 0.2ml of each intervention (Experimental: Novel lubricant Miami Fragrance, Experimental: Novel lubricant Miami no Fragrance, KY Liquid lubricant, Astroglide Gel lubricant) was applied to an occlusive patch and applied to participant's back."
47262|NCT02297841|O1|Outcome|Human Repeat Insult Patch Test|"Experimental: Human Repeat Insult Patch Test~Approximately 0.2ml of each intervention (Experimental: Novel lubricant Miami Fragrance, Experimental: Novel lubricant Miami no Fragrance, KY Liquid lubricant, Astroglide Gel lubricant) was applied to an occlusive patch and applied to participant's back."
47263|NCT02297841|E1|Reported Event|HRIPT|Experimental: Novel lubricant Miami w/ frag Experimental: Novel Miami w/o frag KY Liquid lubricant Astroglide Gel lubricant
47264|NCT02297815|B3|Baseline|Total|Total of all reporting groups
47265|NCT02297815|B2|Baseline|Non-narrow Spectrum Antibiotics|"Child prescribed with the following at time of diagnosis:~Acute otitis media: Amoxicillin-Clavulanate, Azithromycin, Cefdinir, Cefprozil, Cefuroxime Axetil Acute sinusitis: Amoxicillin-Clavulanate, Azithromycin, Cefdinir, Cefprozil, Cefuroxime Axetil Streptococcal pharyngitis: Amoxicillin-Clavulanate, Azithromycin, Cefadroxil, Cefdinir, Cefprozil, Cefuroxime Axetil, Cephalexin"
47266|NCT02297815|B1|Baseline|Narrow Spectrum Antibiotics|"Child prescribed with the following at time of diagnosis:~Acute otitis media: Amoxicillin Acute sinusitis: Amoxicillin Streptococcal pharyngitis: Penicillin or Amoxicillin"
47267|NCT02297815|P2|Participant Flow|Non-narrow Spectrum Antibiotic|Children diagnosed with an ARTI and prescribed a non-narrow spectrum antibiotic
47268|NCT02297815|P1|Participant Flow|Narrow Spectrum Antibiotic|Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic
47269|NCT02297815|O2|Outcome|Non-narrow Spectrum Antibiotic|Children diagnosed with an ARTI and prescribed a non-narrow spectrum antibiotic
47270|NCT02297815|O1|Outcome|Narrow Spectrum Antibiotic|Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic
47271|NCT02297815|O2|Outcome|Non-narrow Spectrum Antibiotic|Children diagnosed with an ARTI and prescribed a non-narrow spectrum antibiotic
47272|NCT02297815|O1|Outcome|Narrow Spectrum Antibiotic|Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic
47273|NCT02297815|O2|Outcome|Non-narrow Spectrum Antibiotic|Children diagnosed with an ARTI and prescribed a non-narrow spectrum antibiotic
47274|NCT02297815|O1|Outcome|Narrow Spectrum Antibiotic|Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic
47275|NCT02297815|O2|Outcome|Non-narrow Spectrum Antibiotic|Children diagnosed with an ARTI and prescribed a non-narrow spectrum antibiotic
47276|NCT02297815|O1|Outcome|Narrow Spectrum Antibiotic|Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic
47287|NCT02297230|B4|Baseline|Arm 4: Paclitaxel/Trastuzumab and RT|Trastuzumab (Herceptin®) tx will be administered weekly, together with one of the 2 weekly doses of Paclitaxel to Her-2/neu Positive patients. The 1st dose will be 4mg/kg given IV over 90 minutes. Weekly doses will b given at a dose of 2 17mg/kg/week IV over 30 minutes. The Tx with Trastuzumab will continue weekly after the completion of the radiation tx until surgery & thereafter as per std of care up to 1 yr post surgery.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Tx will be administered on a Monday/Thursday or Tuesday/Friday schedule.The radiation treatment will start within 1 week from the first dose of paclitaxel and trastuzumab.
47288|NCT02297230|B3|Baseline|Arm 3: Paclitaxel and RT|Paclitaxel 30 mg/m2 twice per week given IV over 1 hour to Her-2/neu negative patients. Treatment will be initiated during the first week of radiation therapy and should be administered on a Monday/Thursday or Tuesday/Friday schedule.
47289|NCT02297230|B2|Baseline|Arm 2 Paclitaxel/Trastuzumab and RT|"Trastuzumab (Herceptin®) will begin on day 1 of radiation therapy and be administered weekly to Her-2/neu Positive patients. The first dose will be 4mg/kg given IV over 90 minutes. Weekly doses will be 2 mg/kg/week IV over 30 minutes.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour.~r"
47290|NCT02297230|B1|Baseline|Arm 1 Capecitabine and RT|Her-2/neu negative patients will be given Capecitabine (xeloda, 750mg/m2 twice daily orally. Treatment should begin on day 1 of radiation therapy. The two doses should be taken about 30 minutes after eating (eg. after breakfast and after dinner). Treatment will be given for 10 weeks (for 6 weeks during radiation and for 4 weeks after radiation).
47291|NCT02297230|P4|Participant Flow|Arm 4: Paclitaxel/Trastuzumab and RT|Trastuzumab (Herceptin®) tx will be administered weekly, together with one of the 2 weekly doses of Paclitaxel to Her-2/neu Positive patients. The 1st dose will be 4mg/kg given IV over 90 minutes. Weekly doses will b given at a dose of 2 17mg/kg/week IV over 30 minutes. The Tx with Trastuzumab will continue weekly after the completion of the radiation tx until surgery & thereafter as per std of care up to 1 yr post surgery.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Tx will be administered on a Monday/Thursday or Tuesday/Friday schedule.The radiation treatment will start within 1 week from the first dose of paclitaxel and trastuzumab.
47292|NCT02297230|P3|Participant Flow|Arm 3: Paclitaxel and RT|Paclitaxel: Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Treatment will be administered on a Monday/Thursday or Tuesday/Friday schedule.The radiation treatment will start within 1 week from the first dose of paclitaxel and trastuzumab. Pre-meds for paclitaxel should be based on the institutional standards; it is suggested that dexamethasone (Decadron®), 20 mg IV, be given with
47293|NCT02297230|P2|Participant Flow|Arm 2 Paclitaxel/Trastuzumab and RT|"Trastuzumab (Herceptin®) will begin on day 1 of radiation therapy and be administered weekly to Her-2/neu Positive patients. The first dose will be 4mg/kg given IV over 90 minutes. Weekly doses will be 2 mg/kg/week IV over 30 minutes.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour.~radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.~Trastuzumab: Trastuzumab (Herceptin®) treatment will be administered weekly, together with one of the two weekly doses of Paclitaxel. The first dose will be 4mg/kg given IV over 90 minutes. Subsequent weekly doses will be given at a dose of 2 mg/kg/week IV over 30 minutes. The treatment with Trastuzumab will continue weekly after the"
47294|NCT02297230|P1|Participant Flow|Arm 1 Capecitabine and RT|"Her-2/neu negative patients will be given Capecitabine (xeloda, 750mg/m2 twice daily orally. Treatment should begin on day 1 of radiation therapy. The two doses should be taken about 30 minutes after eating (eg. after breakfast and after dinner). Treatment will be given for 10 weeks (for 6 weeks during radiation and for 4 weeks after radiation).~radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.~Capecitabine: Capecitabine (Xeloda®) 750 mg/m2 twice/daily given orally. Treatment should begin on day 1 of radiation therapy. The two doses should be taken about 30 minutes after eating (eg. after breakfast and after dinner). Treatment will be given for 10 weeks (for 6 weeks"
47295|NCT02297230|O4|Outcome|Arm 4: Paclitaxel/Trastuzumab and RT|"Trastuzumab (Herceptin®) tx will be administered weekly, together with one of the 2 weekly doses of Paclitaxel to Her-2/neu Positive patients.~Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surger"
47296|NCT02297230|O3|Outcome|Arm 3: Paclitaxel and RT|"Paclitaxel 30 mg/m2 twice per week given IV over 1 hour to Her-2/neu negative patients. Treatment will be initiated during the first week of radiation therapy and should be administered on a Monday/Thursday or Tuesday/Friday schedule.~Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total."
47297|NCT02297230|O2|Outcome|Arm 2 Paclitaxel/Trastuzumab and RT|"Trastuzumab (Herceptin®) will begin on day 1 of radiation therapy and be administered weekly to Her-2/neu Positive patients. The first dose will be 4mg/kg given IV over 90 minutes. Weekly doses will be 2 mg/kg/week IV over 30 minutes.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour.~radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.~Trastuzumab: Trastuzumab (Herceptin®) treatment will be administered weekly, together with one of the two weekly doses of Paclitaxel. The first dose will be 4mg/kg given IV over 90 minutes. Subsequent weekly doses will be given at a dose of 2 mg/kg/week IV over 30 minutes. The treatment with Trastuzumab will continue weekly after the"
47363|NCT02296476|O1|Outcome|MK-8628 80 mg|Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47364|NCT02296476|O3|Outcome|MK-8628 160 mg|Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47298|NCT02297230|O1|Outcome|Arm 1 Capecitabine and RT|"Her-2/neu negative patients will be given Capecitabine (xeloda, 750mg/m2 twice daily orally. Treatment should begin on day 1 of radiation therapy. The two doses should be taken about 30 minutes after eating (eg. after breakfast and after dinner). Treatment will be given for 10 weeks (for 6 weeks during radiation and for 4 weeks after radiation).~radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.~Capecitabine: Capecitabine (Xeloda®) 750 mg/m2 twice/daily given orally. Treatment should begin on day 1 of radiation therapy. The two doses should be taken about 30 minutes after eating (eg. after breakfast and after dinner). Treatment will be given for 10 weeks (for 6 weeks"
47299|NCT02297230|O4|Outcome|Arm 4: Paclitaxel/Trastuzumab and RT|"Trastuzumab (Herceptin®) tx will be administered weekly, together with one of the 2 weekly doses of Paclitaxel to Her-2/neu Positive patients. The 1st dose will be 4mg/kg given IV over 90 minutes. Weekly doses will b given at a dose of 2 17mg/kg/week IV over 30 minutes. The Tx with Trastuzumab will continue weekly after the completion of the radiation tx until surgery & thereafter as per std of care up to 1 yr post surgery.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Tx will be administered on a Monday/Thursday or Tuesday/Friday schedule.The radiation treatment will start within 1 week from the first dose of paclitaxel and trastuzumab.~radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor."
47300|NCT02297230|O3|Outcome|Arm 3: Paclitaxel and RT|"Paclitaxel 30 mg/m2 twice per week given IV over 1 hour to Her-2/neu negative patients. -~radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.~Paclitaxel: Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Treatment will be administered on a Monday/Thursday or Tuesday/Friday schedule.The radiation treatment will start within 1 week from the first dose of paclitaxel and trastuzumab. Pre-meds for paclitaxel should be based on the institutional standards; it is suggested that dexamethasone (Decadron®), 20 mg IV, be given with"
47301|NCT02297230|O2|Outcome|Arm 2 Paclitaxel/Trastuzumab and RT|"Trastuzumab (Herceptin®) will begin on day 1 of radiation therapy and be administered weekly to Her-2/neu Positive patients. The first dose will be 4mg/kg given IV over 90 minutes. Weekly doses will be 2 mg/kg/week IV over 30 minutes.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour.~radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor~Trastuzumab: Trastuzumab (Herceptin®) treatment will be administered weekly, together with one of the two weekly doses of Paclitaxel.~Paclitaxel: Paclitaxel 30 mg/m2 twice per week given IV over 1 hour."
47302|NCT02297230|O1|Outcome|Arm 1 Capecitabine and RT|"radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.~Capecitabine: Capecitabine (Xeloda®) 750 mg/m2 twice/daily given orally. Treatment should begin on day 1 of radiation therapy. The two doses should be taken about 30 minutes after eating (eg. after breakfast and after dinner). Treatment will be given for 10 weeks (for 6 weeks during radiation and for 4 weeks after radiation)."
47303|NCT02297230|O4|Outcome|Arm 4: Paclitaxel/Trastuzumab and RT|"Trastuzumab (Herceptin®) tx will be administered weekly, together with one of the 2 weekly doses of Paclitaxel to Her-2/neu Positive patients.~Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surger"
47304|NCT02297230|O3|Outcome|Arm 3: Paclitaxel and RT|"Paclitaxel 30 mg/m2 twice per week given IV over 1 hour to Her-2/neu negative patients. Treatment will be initiated during the first week of radiation therapy and should be administered on a Monday/Thursday or Tuesday/Friday schedule.~Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total."
47305|NCT02297230|O2|Outcome|Arm 2 Paclitaxel/Trastuzumab and RT|"Trastuzumab (Herceptin®) will begin on day 1 of radiation therapy and be administered weekly to Her-2/neu Positive patients. The first dose will be 4mg/kg given IV over 90 minutes. Weekly doses will be 2 mg/kg/week IV over 30 minutes.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour.~radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.~Trastuzumab: Trastuzumab (Herceptin®) treatment will be administered weekly, together with one of the two weekly doses of Paclitaxel. The first dose will be 4mg/kg given IV over 90 minutes. Subsequent weekly doses will be given at a dose of 2 mg/kg/week IV over 30 minutes. The treatment with Trastuzumab will continue weekly after the"
47306|NCT02297230|O1|Outcome|Arm 1 Capecitabine and RT|"Her-2/neu negative patients will be given Capecitabine (xeloda, 750mg/m2 twice daily orally. Treatment should begin on day 1 of radiation therapy. The two doses should be taken about 30 minutes after eating (eg. after breakfast and after dinner). Treatment will be given for 10 weeks (for 6 weeks during radiation and for 4 weeks after radiation).~radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.~Capecitabine: Capecitabine (Xeloda®) 750 mg/m2 twice/daily given orally. Treatment should begin on day 1 of radiation therapy. The two doses should be taken about 30 minutes after eating (eg. after breakfast and after dinner). Treatment will be given for 10 weeks (for 6 weeks"
47501|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
47307|NCT02297230|O4|Outcome|Arm 4: Paclitaxel/Trastuzumab and RT|Trastuzumab (Herceptin®) tx will be administered weekly, together with one of the 2 weekly doses of Paclitaxel to Her-2/neu Positive patients. The 1st dose will be 4mg/kg given IV over 90 minutes. Weekly doses will b given at a dose of 2 17mg/kg/week IV over 30 minutes. The Tx with Trastuzumab will continue weekly after the completion of the radiation tx until surgery & thereafter as per std of care up to 1 yr post surgery.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Tx will be administered on a Monday/Thursday or Tuesday/Friday schedule.The radiation treatment will start within 1 week from the first dose of paclitaxel and trastuzumab.
47308|NCT02297230|O3|Outcome|Arm 3: Paclitaxel and RT|Paclitaxel: Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Treatment will be administered on a Monday/Thursday or Tuesday/Friday schedule.The radiation treatment will start within 1 week from the first dose of paclitaxel and trastuzumab. Pre-meds for paclitaxel should be based on the institutional standards; it is suggested that dexamethasone (Decadron®), 20 mg IV, be given with
47309|NCT02297230|O2|Outcome|Arm 2 Paclitaxel/Trastuzumab and RT|"Trastuzumab (Herceptin®) will begin on day 1 of radiation therapy and be administered weekly to Her-2/neu Positive patients. The first dose will be 4mg/kg given IV over 90 minutes. Weekly doses will be 2 mg/kg/week IV over 30 minutes.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour.~radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.~Trastuzumab: Trastuzumab (Herceptin®) treatment will be administered weekly, together with one of the two weekly doses of Paclitaxel. The first dose will be 4mg/kg given IV over 90 minutes. Subsequent weekly doses will be given at a dose of 2 mg/kg/week IV over 30 minutes. The treatment with Trastuzumab will continue weekly after the"
47310|NCT02297230|O1|Outcome|Arm 1 Capecitabine and RT|"Her-2/neu negative patients will be given Capecitabine (xeloda, 750mg/m2 twice daily orally. Treatment should begin on day 1 of radiation therapy. The two doses should be taken about 30 minutes after eating (eg. after breakfast and after dinner). Treatment will be given for 10 weeks (for 6 weeks during radiation and for 4 weeks after radiation).~radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.~Capecitabine: Capecitabine (Xeloda®) 750 mg/m2 twice/daily given orally. Treatment should begin on day 1 of radiation therapy. The two doses should be taken about 30 minutes after eating (eg. after breakfast and after dinner). Treatment will be given for 10 weeks (for 6 weeks"
47311|NCT02297230|E4|Reported Event|Arm 4: Paclitaxel/Trastuzumab and RT|"Trastuzumab (Herceptin®) tx will be administered weekly, together with one of the 2 weekly doses of Paclitaxel to Her-2/neu Positive patients. The 1st dose will be 4mg/kg given IV over 90 minutes. Weekly doses will b given at a dose of 2 17mg/kg/week IV over 30 minutes. The Tx with Trastuzumab will continue weekly after the completion of the radiation tx until surgery & thereafter as per std of care up to 1 yr post surgery.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Tx will be administered on a Monday/Thursday or Tuesday/Friday schedule.The radiation treatment will start within 1 week from the first dose of paclitaxel and trastuzumab.~radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor."
47312|NCT02297230|E3|Reported Event|Arm 3: Paclitaxel and RT|"Paclitaxel 30 mg/m2 twice per week given IV over 1 hour to Her-2/neu negative patients. -~radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.~Paclitaxel: Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Treatment will be administered on a Monday/Thursday or Tuesday/Friday schedule.The radiation treatment will start within 1 week from the first dose of paclitaxel and trastuzumab. Pre-meds for paclitaxel should be based on the institutional standards; it is suggested that dexamethasone (Decadron®), 20 mg IV, be given with"
47313|NCT02297230|E2|Reported Event|Arm 2 Paclitaxel/Trastuzumab and RT|"Trastuzumab (Herceptin®) will begin on day 1 of radiation therapy and be administered weekly to Her-2/neu Positive patients. The first dose will be 4mg/kg given IV over 90 minutes. Weekly doses will be 2 mg/kg/week IV over 30 minutes.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour.~radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor~Trastuzumab: Trastuzumab (Herceptin®) treatment will be administered weekly, together with one of the two weekly doses of Paclitaxel.~Paclitaxel: Paclitaxel 30 mg/m2 twice per week given IV over 1 hour."
47314|NCT02297230|E1|Reported Event|Arm 1 Capecitabine and RT|"radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.~Capecitabine: Capecitabine (Xeloda®) 750 mg/m2 twice/daily given orally. Treatment should begin on day 1 of radiation therapy. The two doses should be taken about 30 minutes after eating (eg. after breakfast and after dinner). Treatment will be given for 10 weeks (for 6 weeks during radiation and for 4 weeks after radiation)."
47315|NCT02297100|B3|Baseline|Total|Total of all reporting groups
47316|NCT02297100|B2|Baseline|Botox Periphery of Trigone|"Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone).~Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections~injections on posterior bladder wall excluding the trigone: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder."
47365|NCT02296476|O2|Outcome|MK-8628 120 mg|Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
48059|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
47317|NCT02297100|B1|Baseline|Botox Upper Aspect Trigone|"Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder.~Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections~injections upper aspect of trigone of urinary bladder: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder."
47318|NCT02297100|P2|Participant Flow|Botox Periphery of Trigone|"Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone).~Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections~injections on posterior bladder wall excluding the trigone: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder."
47319|NCT02297100|P1|Participant Flow|Botox Upper Aspect Trigone|"Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder.~Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections~injections upper aspect of trigone of urinary bladder: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder."
47320|NCT02297100|O2|Outcome|Botox Periphery of Trigone|"Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone).~Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections~injections on posterior bladder wall excluding the trigone: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder."
47321|NCT02297100|O1|Outcome|Botox Upper Aspect Trigone|"Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder.~Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections~injections upper aspect of trigone of urinary bladder: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder."
47322|NCT02297100|O2|Outcome|Botox Periphery of Trigone|"Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone).~Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections~injections on posterior bladder wall excluding the trigone: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder."
47323|NCT02297100|O1|Outcome|Botox Upper Aspect Trigone|"Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder.~Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections~injections upper aspect of trigone of urinary bladder: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder."
47324|NCT02297100|O2|Outcome|Botox Periphery of Trigone|"Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone).~Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections~injections on posterior bladder wall excluding the trigone: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder."
47325|NCT02297100|O1|Outcome|Botox Upper Aspect Trigone|"Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder.~Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections~injections upper aspect of trigone of urinary bladder: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder."
47326|NCT02297100|O2|Outcome|Botox Periphery of Trigone|"Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone).~Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections~injections on posterior bladder wall excluding the trigone: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder."
47327|NCT02297100|O1|Outcome|Botox Upper Aspect Trigone|"Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder.~Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections~injections upper aspect of trigone of urinary bladder: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder."
47366|NCT02296476|O1|Outcome|MK-8628 80 mg|Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47367|NCT02296476|O3|Outcome|MK-8628 160 mg|Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47328|NCT02297100|E2|Reported Event|Botox Periphery of Trigone|"Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone).~Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections~injections on posterior bladder wall excluding the trigone: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder."
47329|NCT02297100|E1|Reported Event|Botox Upper Aspect Trigone|"Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder.~Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections~injections upper aspect of trigone of urinary bladder: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder."
47330|NCT02296931|B3|Baseline|Total|Total of all reporting groups
47331|NCT02296931|B2|Baseline|Pre-eclamptic Pregnant Women|"In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia.~Magnesium Sulfate: The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)"
47332|NCT02296931|B1|Baseline|Healthy Adults|"Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women.~Saline: Standard IV Saline Fluids"
47333|NCT02296931|P2|Participant Flow|Pre-eclamptic Pregnant Women|"In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia.~Magnesium Sulfate: The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)"
47334|NCT02296931|P1|Participant Flow|Healthy Adults|"Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women.~Saline: Standard IV Saline Fluids"
47335|NCT02296931|O2|Outcome|Pre-eclamptic Pregnant Women|"In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia.~Magnesium Sulfate: The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)"
47336|NCT02296931|O1|Outcome|Healthy Adults|"Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women.~Saline: Standard IV Saline Fluids"
47337|NCT02296931|E2|Reported Event|Pre-eclamptic Pregnant Women|"In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia.~Magnesium Sulfate: The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)"
47338|NCT02296931|E1|Reported Event|Healthy Adults|"Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women.~Saline: Standard IV Saline Fluids"
47339|NCT02296840|B3|Baseline|Total|Total of all reporting groups
47340|NCT02296840|B2|Baseline|Hydrocodone-acetaminophen|Participants randomized to receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours) after undergoing adenotonsillectomy.
47341|NCT02296840|B1|Baseline|Ibuprofen|Participants randomized to receive ibuprofen (10mg/kg/day every 6-8 hours) after undergoing adenotonsillectomy.
47342|NCT02296840|P2|Participant Flow|Hydrocodone-acetaminophen|Participants randomized to receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours) after undergoing adenotonsillectomy.
47343|NCT02296840|P1|Participant Flow|Ibuprofen|Participants randomized to receive ibuprofen (10mg/kg/day every 6-8 hours) after undergoing adenotonsillectomy.
47344|NCT02296840|O2|Outcome|Hydrocodone-acetaminophen|Participants randomized to receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours) after undergoing adenotonsillectomy.
47345|NCT02296840|O1|Outcome|Ibuprofen|Participants randomized to receive ibuprofen (10mg/kg/day every 6-8 hours) after undergoing adenotonsillectomy.
47346|NCT02296840|O2|Outcome|Hydrocodone-acetaminophen|Participants randomized to receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours) after undergoing adenotonsillectomy.
47347|NCT02296840|O1|Outcome|Ibuprofen|Participants randomized to receive ibuprofen (10mg/kg/day every 6-8 hours) after undergoing adenotonsillectomy.
47348|NCT02296840|E2|Reported Event|Hydrocodone-acetaminophen|Participants randomized to receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours) after undergoing adenotonsillectomy.
47349|NCT02296840|E1|Reported Event|Ibuprofen|Participants randomized to receive ibuprofen (10mg/kg/day every 6-8 hours) after undergoing adenotonsillectomy.
47350|NCT02296606|B1|Baseline|All Participants|
47351|NCT02296606|P1|Participant Flow|All Participants|All participants underwent three pupil exams, two by flashlight/pen light by two different assessors, and one by a researcher using the Pupillometer Device. Pupil exams occurred up to three times daily for the extent that the patient was in the ICU at the enrolling hospital.
47352|NCT02296606|O1|Outcome|All Participants|There are no groups/arms for the purpose of this study.
47353|NCT02296606|E1|Reported Event|All Participants|There are no groups/arms for the purpose of this study.
47354|NCT02296476|B4|Baseline|Total|Total of all reporting groups
47355|NCT02296476|B3|Baseline|MK-8628 160 mg|Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47356|NCT02296476|B2|Baseline|MK-8628 120 mg|Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47357|NCT02296476|B1|Baseline|MK-8628 80 mg|Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47358|NCT02296476|P3|Participant Flow|MK-8628 160 mg|Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47359|NCT02296476|P2|Participant Flow|MK-8628 120 mg|Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47360|NCT02296476|P1|Participant Flow|MK-8628 80 mg|Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47370|NCT02296476|O3|Outcome|MK-8628 160 mg|Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47371|NCT02296476|O2|Outcome|MK-8628 120 mg|Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47372|NCT02296476|O1|Outcome|MK-8628 80 mg|Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47373|NCT02296476|O3|Outcome|MK-8628 160 mg|Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47374|NCT02296476|O2|Outcome|MK-8628 120 mg|Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47375|NCT02296476|O1|Outcome|MK-8628 80 mg|Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47376|NCT02296476|O3|Outcome|MK-8628 160 mg|Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47377|NCT02296476|O2|Outcome|MK-8628 120 mg|Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47378|NCT02296476|O1|Outcome|MK-8628 80 mg|Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47379|NCT02296476|O3|Outcome|MK-8628 160 mg|Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47380|NCT02296476|O2|Outcome|MK-8628 120 mg|Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47381|NCT02296476|O1|Outcome|MK-8628 80 mg|Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47382|NCT02296476|O3|Outcome|MK-8628 160 mg|Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47383|NCT02296476|O2|Outcome|MK-8628 120 mg|Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47384|NCT02296476|O1|Outcome|MK-8628 80 mg|Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47385|NCT02296476|O3|Outcome|MK-8628 160 mg|Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47386|NCT02296476|O2|Outcome|MK-8628 120 mg|Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47387|NCT02296476|O1|Outcome|MK-8628 80 mg|Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47388|NCT02296476|O3|Outcome|MK-8628 160 mg|Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47389|NCT02296476|O2|Outcome|MK-8628 120 mg|Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47390|NCT02296476|O1|Outcome|MK-8628 80 mg|Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47391|NCT02296476|O3|Outcome|MK-8628 160 mg|Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47392|NCT02296476|O2|Outcome|MK-8628 120 mg|Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47393|NCT02296476|O1|Outcome|MK-8628 80 mg|Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47394|NCT02296476|O3|Outcome|MK-8628 160 mg|Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47395|NCT02296476|O2|Outcome|MK-8628 120 mg|Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47396|NCT02296476|O1|Outcome|MK-8628 80 mg|Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47397|NCT02296476|O3|Outcome|MK-8628 160 mg|Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47398|NCT02296476|O2|Outcome|MK-8628 120 mg|Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47399|NCT02296476|O1|Outcome|MK-8628 80 mg|Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47400|NCT02296476|O3|Outcome|MK-8628 160 mg|Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47401|NCT02296476|O2|Outcome|MK-8628 120 mg|Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47402|NCT02296476|O1|Outcome|MK-8628 80 mg|Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47403|NCT02296476|O3|Outcome|MK-8628 160 mg|Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47404|NCT02296476|O2|Outcome|MK-8628 120 mg|Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47405|NCT02296476|O1|Outcome|MK-8628 80 mg|Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47406|NCT02296476|O3|Outcome|MK-8628 160 mg|Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47407|NCT02296476|O2|Outcome|MK-8628 120 mg|Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
68281|NCT02151461|O1|Outcome|FDC125|Leucine 1100mg +Metformin 125mg
47408|NCT02296476|O1|Outcome|MK-8628 80 mg|Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47409|NCT02296476|E3|Reported Event|MK-8628 160 mg|Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47410|NCT02296476|E2|Reported Event|MK-8628 120 mg|Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47411|NCT02296476|E1|Reported Event|MK-8628 80 mg|Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
47412|NCT02296099|B3|Baseline|Total|Total of all reporting groups
47413|NCT02296099|B2|Baseline|Saline Placebo|Normal saline 30 mL total injected. Ten mL injected into the vaginal epithelium in the mid-urethral area and 10 mL will be injected into each of the trocar paths through the suprapubic incisions bilaterally.
47414|NCT02296099|B1|Baseline|Liposomal Bupivacaine|Liposomal bupivacaine 20 mL diluted with 10 mL normal saline. Ten mL of solution to be injected into the vaginal epithelium in the mid-urethral area and 10 mL injected into each of the trocar paths through the suprapubic incisions bilaterally.
47415|NCT02296099|P2|Participant Flow|Saline Placebo|Normal saline 30 mL total injected. Ten mL injected into the vaginal epithelium in the mid-urethral area and 10 mL will be injected into each of the trocar paths through the suprapubic incisions bilaterally.
47416|NCT02296099|P1|Participant Flow|Liposomal Bupivacaine|Liposomal bupivacaine 20 mL diluted with 10 mL normal saline. Ten mL of solution to be injected into the vaginal epithelium in the mid-urethral area and 10 mL injected into each of the trocar paths through the suprapubic incisions bilaterally.
47417|NCT02296099|O2|Outcome|Saline Placebo|Normal saline 30 mL total injected. Ten mL injected into the vaginal epithelium in the mid-urethral area and 10 mL will be injected into each of the trocar paths through the suprapubic incisions bilaterally.
47418|NCT02296099|O1|Outcome|Liposomal Bupivacaine|Liposomal bupivacaine 20 mL diluted with 10 mL normal saline. Ten mL of solution to be injected into the vaginal epithelium in the mid-urethral area and 10 mL injected into each of the trocar paths through the suprapubic incisions bilaterally.
47419|NCT02296099|O2|Outcome|Saline Placebo|Normal saline 30 mL total injected. Ten mL injected into the vaginal epithelium in the mid-urethral area and 10 mL will be injected into each of the trocar paths through the suprapubic incisions bilaterally.
47420|NCT02296099|O1|Outcome|Liposomal Bupivacaine|Liposomal bupivacaine 20 mL diluted with 10 mL normal saline. Ten mL of solution to be injected into the vaginal epithelium in the mid-urethral area and 10 mL injected into each of the trocar paths through the suprapubic incisions bilaterally.
47421|NCT02296099|O2|Outcome|Saline Placebo|Normal saline 30 mL total injected. Ten mL injected into the vaginal epithelium in the mid-urethral area and 10 mL will be injected into each of the trocar paths through the suprapubic incisions bilaterally.
47422|NCT02296099|O1|Outcome|Liposomal Bupivacaine|Liposomal bupivacaine 20 mL diluted with 10 mL normal saline. Ten mL of solution to be injected into the vaginal epithelium in the mid-urethral area and 10 mL injected into each of the trocar paths through the suprapubic incisions bilaterally.
47423|NCT02296099|O2|Outcome|Saline Placebo|Normal saline 30 mL total injected. Ten mL injected into the vaginal epithelium in the mid-urethral area and 10 mL will be injected into each of the trocar paths through the suprapubic incisions bilaterally.
47424|NCT02296099|O1|Outcome|Liposomal Bupivacaine|Liposomal bupivacaine 20 mL diluted with 10 mL normal saline. Ten mL of solution to be injected into the vaginal epithelium in the mid-urethral area and 10 mL injected into each of the trocar paths through the suprapubic incisions bilaterally.
47425|NCT02296099|O2|Outcome|Saline Placebo|Normal saline 30 mL total injected. Ten mL injected into the vaginal epithelium in the mid-urethral area and 10 mL will be injected into each of the trocar paths through the suprapubic incisions bilaterally.
47426|NCT02296099|O1|Outcome|Liposomal Bupivacaine|Liposomal bupivacaine 20 mL diluted with 10 mL normal saline. Ten mL of solution to be injected into the vaginal epithelium in the mid-urethral area and 10 mL injected into each of the trocar paths through the suprapubic incisions bilaterally.
47427|NCT02296099|O2|Outcome|Saline Placebo|Normal saline 30 mL total injected. Ten mL injected into the vaginal epithelium in the mid-urethral area and 10 mL will be injected into each of the trocar paths through the suprapubic incisions bilaterally.
47428|NCT02296099|O1|Outcome|Liposomal Bupivacaine|Liposomal bupivacaine 20 mL diluted with 10 mL normal saline. Ten mL of solution to be injected into the vaginal epithelium in the mid-urethral area and 10 mL injected into each of the trocar paths through the suprapubic incisions bilaterally.
47429|NCT02296099|O2|Outcome|Saline Placebo|Normal saline 30 mL total injected. Ten mL injected into the vaginal epithelium in the mid-urethral area and 10 mL will be injected into each of the trocar paths through the suprapubic incisions bilaterally.
47430|NCT02296099|O1|Outcome|Liposomal Bupivacaine|Liposomal bupivacaine 20 mL diluted with 10 mL normal saline. Ten mL of solution to be injected into the vaginal epithelium in the mid-urethral area and 10 mL injected into each of the trocar paths through the suprapubic incisions bilaterally.
47431|NCT02296099|O2|Outcome|Saline Placebo|Normal saline 30 mL total injected. Ten mL injected into the vaginal epithelium in the mid-urethral area and 10 mL will be injected into each of the trocar paths through the suprapubic incisions bilaterally.
47432|NCT02296099|O1|Outcome|Liposomal Bupivacaine|Liposomal bupivacaine 20 mL diluted with 10 mL normal saline. Ten mL of solution to be injected into the vaginal epithelium in the mid-urethral area and 10 mL injected into each of the trocar paths through the suprapubic incisions bilaterally.
47433|NCT02296099|O2|Outcome|Saline Placebo|Normal saline 30 mL total injected. Ten mL injected into the vaginal epithelium in the mid-urethral area and 10 mL will be injected into each of the trocar paths through the suprapubic incisions bilaterally.
47434|NCT02296099|O1|Outcome|Liposomal Bupivacaine|Liposomal bupivacaine 20 mL diluted with 10 mL normal saline. Ten mL of solution to be injected into the vaginal epithelium in the mid-urethral area and 10 mL injected into each of the trocar paths through the suprapubic incisions bilaterally.
47435|NCT02296099|O2|Outcome|Saline Placebo|Normal saline 30 mL total injected. Ten mL injected into the vaginal epithelium in the mid-urethral area and 10 mL will be injected into each of the trocar paths through the suprapubic incisions bilaterally.
68282|NCT02151461|O4|Outcome|Control|Day 1-14: 500mg, Day 15-28: 850mg
47436|NCT02296099|O1|Outcome|Liposomal Bupivacaine|Liposomal bupivacaine 20 mL diluted with 10 mL normal saline. Ten mL of solution to be injected into the vaginal epithelium in the mid-urethral area and 10 mL injected into each of the trocar paths through the suprapubic incisions bilaterally.
47437|NCT02296099|E2|Reported Event|Saline Placebo|Normal saline 30 mL total injected. Ten mL injected into the vaginal epithelium in the mid-urethral area and 10 mL will be injected into each of the trocar paths through the suprapubic incisions bilaterally.
47438|NCT02296099|E1|Reported Event|Liposomal Bupivacaine|Liposomal bupivacaine 20 mL diluted with 10 mL normal saline. Ten mL of solution to be injected into the vaginal epithelium in the mid-urethral area and 10 mL injected into each of the trocar paths through the suprapubic incisions bilaterally.
47439|NCT02295774|B1|Baseline|Group A|"Biopsy samples collected during standard white light colonoscopy.~standard white light colonoscopy-equivalent to placebo: standard white light colonoscopy~No study drug was taken prior to initial Colonoscopy (White light only)~Subjects who have had samples collected during initial colonoscopy, who require a second colonoscopy within 2 weeks. Prior to this second colonoscopy the subjects take Methylene Blue MMX tablets. Biopsies collected are compared to their initial colonoscopy for histone gamma H2AX activity.~Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy"
47440|NCT02295774|P1|Participant Flow|Group A|"Biopsy samples collected during standard white light colonoscopy.~standard white light colonoscopy-equivalent to placebo: standard white light colonoscopy~Subjects who have had samples collected during initial colonoscopy, who require a second colonoscopy within 2 weeks. Prior to initial colonoscopy the subjects take Methylene Blue MMX tablets.~Biopsies collected are compared to their initial colonoscopy for histone gamma H2AX activity.~Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy"
47441|NCT02295774|O1|Outcome|Group A|"This is a crossover study. Biopsy samples collected during standard white light colonoscopy.~standard white light colonoscopy-equivalent to placebo: standard white light colonoscopy~Subjects who have had samples collected during initial colonoscopy, who require a second colonoscopy within 2 weeks. Prior to this second colonoscopy the subjects take Methylene Blue MMX tablets.~Biopsies collected are compared to their initial colonoscopy for histone gamma H2AX activity.~Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy"
47442|NCT02295774|E1|Reported Event|Group A|"This is a crossover study.~Biopsy samples collected during standard white light colonoscopy.~standard white light colonoscopy-equivalent to placebo: standard white light colonoscopy~No study drug was taken prior to initial Colonoscopy (White light only)~Subjects who have had samples collected during initial colonoscopy, who require a second colonoscopy within 2 weeks.~Prior to this second colonoscopy the subjects take Methylene Blue MMX tablets. Biopsies collected are compared to their initial colonoscopy for histone gamma H2AX activity.~Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy"
47443|NCT02295644|B5|Baseline|Total|Total of all reporting groups
47444|NCT02295644|B4|Baseline|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
47445|NCT02295644|B3|Baseline|C (0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
47446|NCT02295644|B2|Baseline|B(0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
47447|NCT02295644|B1|Baseline|A(0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
47448|NCT02295644|P4|Participant Flow|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
47449|NCT02295644|P3|Participant Flow|C (0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
47450|NCT02295644|P2|Participant Flow|B (0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
47451|NCT02295644|P1|Participant Flow|A (0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
47452|NCT02295644|O4|Outcome|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
47453|NCT02295644|O3|Outcome|C (0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
47454|NCT02295644|O2|Outcome|B (0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
47455|NCT02295644|O1|Outcome|A (0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
47456|NCT02295644|O4|Outcome|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
47457|NCT02295644|O3|Outcome|C (0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
47458|NCT02295644|O2|Outcome|B (0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
47459|NCT02295644|O1|Outcome|A (0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
47460|NCT02295644|O4|Outcome|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
47461|NCT02295644|O3|Outcome|C (0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
47462|NCT02295644|O2|Outcome|B (0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
47463|NCT02295644|O1|Outcome|A (0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
47464|NCT02295644|E4|Reported Event|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
47465|NCT02295644|E3|Reported Event|C(0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
47466|NCT02295644|E2|Reported Event|B(0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
47467|NCT02295644|E1|Reported Event|A(0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
47468|NCT02295280|B3|Baseline|Total|Total of all reporting groups
47469|NCT02295280|B2|Baseline|Codeine|Normotensive pregnant women in the second or third trimester were randomized to receive either MAD intravenously (10 mg and 25 mg, respectively) or codeine (30 mg) for headache symptoms after 650-1000 mg of acetaminophen failed to relieve the headache.
47470|NCT02295280|B1|Baseline|Metoclopramide IV & Diphenhydramine IV|Normotensive pregnant women in the second or third trimester were randomized to receive either MAD intravenously (10 mg and 25 mg, respectively) or codeine (30 mg) for headache symptoms after 650-1000 mg of acetaminophen failed to relieve the headache.
47471|NCT02295280|P2|Participant Flow|Codeine|"Group B (control group) will receive standard treatment consisting of a codeine 30mg tablet.~Codeine: PO"
47472|NCT02295280|P1|Participant Flow|Metoclopramide IV & Diphenhydramine IV|"Intravenous (IV) access will be obtained and administration of 10mg Metoclopramide IV and 25mg Diphenhydramine IV Group A~Metoclopramide: IV~Diphenhydramine: iv"
47473|NCT02295280|O2|Outcome|Codeine|Number of patients who received codeine
47474|NCT02295280|O1|Outcome|Metoclopramide IV & Diphenhydramine IV|Number of patients who received Metoclopramide & diphenhydramine IV
47475|NCT02295280|E2|Reported Event|Codeine|Participants received oral 30 mg of oral codeine (up to two doses).
47476|NCT02295280|E1|Reported Event|Metoclopramide & Diphenhydramine|Participants received intravenous metoclopramine (10 mg) and diphenhydramine (25 mg), up to two doses of each medication.
47477|NCT02295020|B3|Baseline|Total|Total of all reporting groups
47478|NCT02295020|B2|Baseline|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
47479|NCT02295020|B1|Baseline|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
47480|NCT02295020|P2|Participant Flow|Standard Treatment Plus Bioskin Ten-7.|"Group B will receive standard treatment and the Bioskin Ten-7 knee brace.~Standard treatment: Standard treatment such as NSAIDs and injections~Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace"
47481|NCT02295020|P1|Participant Flow|Standard Treatment Only.|"Group A will receive standard treatment only~Standard treatment: Standard treatment such as NSAIDs and injections"
47482|NCT02295020|O2|Outcome|Group B|"Group B will receive standard treatment and the Bioskin Ten-7 knee brace.~Standard treatment: Standard treatment such as NSAIDs and injections~Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace"
47483|NCT02295020|O1|Outcome|Group A|"Group A will receive standard treatment only~Standard treatment: Standard treatment such as NSAIDs and injections"
47484|NCT02295020|O2|Outcome|Group B|"Group B will receive standard treatment and the Bioskin Ten-7 knee brace.~Standard treatment: Standard treatment such as NSAIDs and injections~Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace"
47485|NCT02295020|O1|Outcome|Group A|"Group A will receive standard treatment only~Standard treatment: Standard treatment such as NSAIDs and injections"
47486|NCT02295020|O2|Outcome|Group B|"Group B will receive standard treatment and the Bioskin Ten-7 knee brace.~Standard treatment: Standard treatment such as NSAIDs and injections~Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace"
47487|NCT02295020|O1|Outcome|Group A|"Group A will receive standard treatment only~Standard treatment: Standard treatment such as NSAIDs and injections"
47488|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace
47489|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
47490|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
47491|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
47492|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace
47493|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
47494|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus knee Bioskin Ten-7 knee brace
47495|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
47496|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace
47497|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections.
47498|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace
47499|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
47500|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace
48060|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
47506|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
47507|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections.
47508|NCT02295020|E2|Reported Event|Group B|"Group B will receive standard treatment and the Bioskin Ten-7 knee brace.~Standard treatment: Standard treatment such as NSAIDs and injections~Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace"
47509|NCT02295020|E1|Reported Event|Group A|"Group A will receive standard treatment only~Standard treatment: Standard treatment such as NSAIDs and injections"
47510|NCT02294773|B3|Baseline|Total|Total of all reporting groups
47511|NCT02294773|B2|Baseline|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
47512|NCT02294773|B1|Baseline|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
47513|NCT02294773|P2|Participant Flow|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
47514|NCT02294773|P1|Participant Flow|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
47515|NCT02294773|O2|Outcome|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
47516|NCT02294773|O1|Outcome|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
47517|NCT02294773|O2|Outcome|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
47518|NCT02294773|O1|Outcome|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
47519|NCT02294773|O2|Outcome|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
47520|NCT02294773|O1|Outcome|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
47521|NCT02294773|O2|Outcome|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
47522|NCT02294773|O1|Outcome|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
47659|NCT02294474|O1|Outcome|SAR342434|SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
47523|NCT02294773|O2|Outcome|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
47524|NCT02294773|O1|Outcome|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
47525|NCT02294773|E2|Reported Event|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
47526|NCT02294773|E1|Reported Event|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
47527|NCT02294734|B3|Baseline|Total|Total of all reporting groups
47528|NCT02294734|B2|Baseline|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47529|NCT02294734|B1|Baseline|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47530|NCT02294734|P2|Participant Flow|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47531|NCT02294734|P1|Participant Flow|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47532|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47533|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47534|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47535|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47536|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47537|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47538|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47539|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47540|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47541|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47542|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47543|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47544|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47545|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47546|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47547|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47548|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47549|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47550|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47551|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47552|NCT02294734|O1|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47553|NCT02294734|O1|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47554|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
48061|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
47555|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47556|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47557|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47558|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47559|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47560|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47561|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47562|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47563|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47564|NCT02294734|O2|Outcome|GSK2269557 1000 µg|Participants received 1000 µg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47565|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47566|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47567|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47568|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47569|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47570|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47571|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47572|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47573|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47574|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47575|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47576|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47577|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47578|NCT02294734|E2|Reported Event|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47579|NCT02294734|E1|Reported Event|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
47580|NCT02294682|B3|Baseline|Total|Total of all reporting groups
47581|NCT02294682|B2|Baseline|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47582|NCT02294682|B1|Baseline|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47583|NCT02294682|P2|Participant Flow|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47584|NCT02294682|P1|Participant Flow|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47585|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47660|NCT02294474|O2|Outcome|Humalog|Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
47661|NCT02294474|O1|Outcome|SAR342434|SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine up to Week 26.
48062|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
47586|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47587|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47588|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47589|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47590|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47591|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47592|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47593|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47594|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47595|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47596|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47597|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47598|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47599|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47600|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47601|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47662|NCT02294474|O2|Outcome|Humalog|Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
47602|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47603|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47604|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47605|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47606|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47607|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47608|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47609|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47610|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47611|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47612|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47613|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47614|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47615|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47616|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47617|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47663|NCT02294474|O1|Outcome|SAR342434|SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
47618|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47619|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47620|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47621|NCT02294682|E2|Reported Event|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47622|NCT02294682|E1|Reported Event|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
47623|NCT02294604|B4|Baseline|Total|Total of all reporting groups
47624|NCT02294604|B3|Baseline|Group C|"Traditional scrub formation with 4% chlorhexidine~chlorhexidine"
47625|NCT02294604|B2|Baseline|Group I|"Traditional scrub formation with 10 % povidone-iodine~povidone-iodine"
47626|NCT02294604|B1|Baseline|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers~ethyl alcochol, chlorhexidine and moisturizers"
47627|NCT02294604|P3|Participant Flow|Group C|"Traditional scrub formation with 4% chlorhexidine~chlorhexidine"
47628|NCT02294604|P2|Participant Flow|Group I|"Traditional scrub formation with 10 % povidone-iodine~povidone-iodine"
47629|NCT02294604|P1|Participant Flow|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers~ethyl alcochol, chlorhexidine and moisturizers"
47630|NCT02294604|O3|Outcome|Group C|"Traditional scrub formation with 4% chlorhexidine~chlorhexidine"
47631|NCT02294604|O2|Outcome|Group I|"Traditional scrub formation with 10 % povidone-iodine~povidone-iodine"
47632|NCT02294604|O1|Outcome|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers~ethyl alcochol, chlorhexidine and moisturizers"
47633|NCT02294604|O3|Outcome|Group C|"Traditional scrub formation with 4% chlorhexidine~chlorhexidine"
47634|NCT02294604|O2|Outcome|Group I|"Traditional scrub formation with 10 % povidone-iodine~povidone-iodine"
47635|NCT02294604|O1|Outcome|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers~ethyl alcochol, chlorhexidine and moisturizers"
47636|NCT02294604|O3|Outcome|Group C|"Traditional scrub formation with 4% chlorhexidine~chlorhexidine"
47637|NCT02294604|O2|Outcome|Group I|"Traditional scrub formation with 10 % povidone-iodine~povidone-iodine"
47638|NCT02294604|O1|Outcome|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers~ethyl alcochol, chlorhexidine and moisturizers"
47639|NCT02294604|O3|Outcome|Group C|"Traditional scrub formation with 4% chlorhexidine~chlorhexidine"
47640|NCT02294604|O2|Outcome|Group I|"Traditional scrub formation with 10 % povidone-iodine~povidone-iodine"
47641|NCT02294604|O1|Outcome|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers~ethyl alcochol, chlorhexidine and moisturizers"
47642|NCT02294604|E3|Reported Event|Group C|"Traditional scrub formation with 4% chlorhexidine~chlorhexidine"
47643|NCT02294604|E2|Reported Event|Group I|"Traditional scrub formation with 10 % povidone-iodine~povidone-iodine"
47644|NCT02294604|E1|Reported Event|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers~ethyl alcochol, chlorhexidine and moisturizers"
47645|NCT02294474|B3|Baseline|Total|Total of all reporting groups
47646|NCT02294474|B2|Baseline|Humalog|Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
47647|NCT02294474|B1|Baseline|SAR342434|SAR342434 100 U/mL subcutaneous (SC) injection before meals intake on top of once daily (QD) Insulin Glargine, up to Week 26.
47648|NCT02294474|P2|Participant Flow|Humalog|Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
47649|NCT02294474|P1|Participant Flow|SAR342434|SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
47650|NCT02294474|O2|Outcome|Humalog|Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
47651|NCT02294474|O1|Outcome|SAR342434|SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
47652|NCT02294474|O2|Outcome|Humalog|Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
47653|NCT02294474|O1|Outcome|SAR342434|SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
47654|NCT02294474|O2|Outcome|Humalog|Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
47655|NCT02294474|O1|Outcome|SAR342434|SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
47656|NCT02294474|O2|Outcome|Humalog|Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
68283|NCT02151461|O3|Outcome|FDC500|Leucine 1100mg +Metformin 500mg
47665|NCT02294474|O1|Outcome|SAR342434|SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
47666|NCT02294474|O2|Outcome|Humalog|Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
47667|NCT02294474|O1|Outcome|SAR342434|SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
47668|NCT02294474|E2|Reported Event|Humalog|Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
47669|NCT02294474|E1|Reported Event|SAR342434|SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
47670|NCT02294461|B3|Baseline|Total|Total of all reporting groups
47671|NCT02294461|B2|Baseline|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47672|NCT02294461|B1|Baseline|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47673|NCT02294461|P2|Participant Flow|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47674|NCT02294461|P1|Participant Flow|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47675|NCT02294461|O2|Outcome|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47676|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47677|NCT02294461|O4|Outcome|Enzalutamide Plus M2|Active metabolite
47678|NCT02294461|O3|Outcome|M2- N-Desmethyl Enzalutamide|N-desmethyl enzalutamide (active metabolite)
47679|NCT02294461|O2|Outcome|M1- Carboxylic Acid Metabolite|Inactive metabolite
47680|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47681|NCT02294461|O4|Outcome|Enzalutamide Plus M2|Active metabolite.
47682|NCT02294461|O3|Outcome|M2- N-Desmethyl Enzalutamide|N-desmethyl enzalutamide (active metabolite).
47683|NCT02294461|O2|Outcome|M1- Carboxylic Acid Metabolite|Inactive metabolite.
47684|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47685|NCT02294461|O4|Outcome|Enzalutamide Plus M2|Active metabolite.
47686|NCT02294461|O3|Outcome|M2- N-Desmethyl Enzalutamide|Active metabolite.
47687|NCT02294461|O2|Outcome|M1- Carboxylic Acid Metabolite|Inactive metabolite.
47688|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47689|NCT02294461|O4|Outcome|Enzalutamide Plus M2|Active metabolite.
47690|NCT02294461|O3|Outcome|M2- N-Desmethyl Enzalutamide|N-desmethyl enzalutamide (active metabolite).
47691|NCT02294461|O2|Outcome|M1- Carboxylic Acid Metabolite|Inactive metabolite.
47692|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47693|NCT02294461|O4|Outcome|Enzalutamide Plus M2|Active metabolite
47694|NCT02294461|O3|Outcome|M2- N-Desmethyl Enzalutamide|N-desmethyl enzalutamide (active metabolite)
47695|NCT02294461|O2|Outcome|M1- Carboxylic Acid Metabolite|Inactive metabolite
47696|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47697|NCT02294461|O4|Outcome|Enzalutamide Plus M2|Active metabolite
47698|NCT02294461|O3|Outcome|M2- N-Desmethyl Enzalutamide|N-desmethyl enzalutamide (active metabolite)
47699|NCT02294461|O2|Outcome|M1- Carboxylic Acid Metabolite|Inactive metabolite
47700|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed.
47701|NCT02294461|O4|Outcome|Enzalutamide Plus M2|
68284|NCT02151461|O2|Outcome|FDC250|Leucine 1100mg +Metformin 250mg
47704|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47705|NCT02294461|O4|Outcome|Enzalutamide Plus M2|Active metabolite
47706|NCT02294461|O3|Outcome|M2- N-Desmethyl Enzalutamide|N-desmethyl enzalutamide (active metabolite)
47707|NCT02294461|O2|Outcome|M1- Carboxylic Acid Metabolite|Inactive metabolite
47708|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47709|NCT02294461|O2|Outcome|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47710|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.disease progression were centrally confirmed.
47711|NCT02294461|O2|Outcome|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47712|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47713|NCT02294461|O2|Outcome|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47714|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47715|NCT02294461|O2|Outcome|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47716|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47717|NCT02294461|O2|Outcome|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47718|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47719|NCT02294461|O2|Outcome|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47720|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47721|NCT02294461|O2|Outcome|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47722|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47723|NCT02294461|E2|Reported Event|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
47724|NCT02294461|E1|Reported Event|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
68285|NCT02151461|O1|Outcome|FDC125|Leucine 1100mg +Metformin 125mg
47725|NCT02294019|B1|Baseline|Ibuprofen|All participants who purchased at least 1 carton of study medication.
47726|NCT02294019|P1|Participant Flow|Ibuprofen|All participants who purchased at least 1 carton of study medication.
47727|NCT02294019|O1|Outcome|Ibuprofen|Participants who purchased and used orally 400 mg caplets of Ibuprofen after reading the drug facts label (DFL), and recorded the use of study medication in the diary on or after the first purchase date, and returned the diary.
47728|NCT02294019|O1|Outcome|Ibuprofen|Participants who purchased and used orally 400 mg caplets of Ibuprofen after reading the drug facts label (DFL), and recorded the use of study medication in the diary on or after the first purchase date, and returned the diary.
47729|NCT02294019|E1|Reported Event|Ibuprofen (Safety Population)|Subjects in the actual use population, and any other subject who provided any follow up information indicating that they used the study product at least once during the study
47730|NCT02293902|B4|Baseline|Total|Total of all reporting groups
47731|NCT02293902|B3|Baseline|Sarilumab 200 mg/200 mg|Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment .
47732|NCT02293902|B2|Baseline|Sarilumab 150 mg/150 mg|Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment .
47733|NCT02293902|B1|Baseline|Placebo|Placebo (for sarilumab) SC injection once q2w in combination with MTX and folic acid in double-blind period up to Week 24. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
47734|NCT02293902|P5|Participant Flow|Placebo/Sarilumab 200 mg|Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
47735|NCT02293902|P4|Participant Flow|Placebo/Sarilumab 150 mg|Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
47736|NCT02293902|P3|Participant Flow|Sarilumab 200 mg/200 mg|Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
47737|NCT02293902|P2|Participant Flow|Sarilumab 150 mg/150 mg|Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
47738|NCT02293902|P1|Participant Flow|Placebo|Placebo (for sarilumab) subcutaneous (SC) injection once every 2 weeks (q2w) in combination with methotrexate (MTX) and folic acid in double-blind period up to Week 24. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
47739|NCT02293902|O6|Outcome|Sarilumab Rescue|Participants who received either placebo or sarilumab 150 mg or 200 mg and had inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits (at least 4 weeks apart) in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment up to Week 52.
47740|NCT02293902|O5|Outcome|Placebo/Sarilumab 200 mg|Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
47741|NCT02293902|O4|Outcome|Placebo/Sarilumab 150 mg|Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
47742|NCT02293902|O3|Outcome|Sarilumab 200 mg/200 mg|Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
47743|NCT02293902|O2|Outcome|Sarilumab 150 mg/150 mg|Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
47744|NCT02293902|O1|Outcome|Placebo|Placebo (for sarilumab) SC injection once q2w in combination with MTX and folic acid in double-blind period up to Week 24.
47745|NCT02293902|O6|Outcome|Sarilumab Rescue|Participants who received either placebo or sarilumab 150 mg or 200 mg and had inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits (at least 4 weeks apart) in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment up to Week 52.
47746|NCT02293902|O5|Outcome|Placebo/Sarilumab 200 mg|Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
47747|NCT02293902|O4|Outcome|Placebo/Sarilumab 150 mg|Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
47748|NCT02293902|O3|Outcome|Sarilumab 200 mg/200 mg|Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
47749|NCT02293902|O2|Outcome|Sarilumab 150 mg/150 mg|Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
47750|NCT02293902|O1|Outcome|Placebo|Placebo (for sarilumab) SC injection once q2w in combination with MTX and folic acid in double-blind period up to Week 24.
47751|NCT02293902|O6|Outcome|Sarilumab Rescue|Participants who received either placebo or sarilumab 150 mg or 200 mg and had inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits (at least 4 weeks apart) in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment up to Week 52.
47752|NCT02293902|O5|Outcome|Placebo/Sarilumab 200 mg|Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
47753|NCT02293902|O4|Outcome|Placebo/Sarilumab 150 mg|Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
47754|NCT02293902|O3|Outcome|Sarilumab 200 mg/200 mg|Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
47755|NCT02293902|O2|Outcome|Sarilumab 150 mg/150 mg|Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
47756|NCT02293902|O1|Outcome|Placebo|Placebo (for sarilumab) SC injection once q2w in combination with MTX and folic acid in double-blind period up to Week 24.
47757|NCT02293902|O6|Outcome|Sarilumab Rescue|Participants who received either placebo or sarilumab 150 mg or 200 mg and had inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits (at least 4 weeks apart) in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment up to Week 52.
47758|NCT02293902|O5|Outcome|Placebo/Sarilumab 200 mg|Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
47759|NCT02293902|O4|Outcome|Placebo/Sarilumab 150 mg|Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
47760|NCT02293902|O3|Outcome|Sarilumab 200 mg/200 mg|Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
47761|NCT02293902|O2|Outcome|Sarilumab 150 mg/150 mg|Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
47762|NCT02293902|O1|Outcome|Placebo|Placebo (for sarilumab) SC injection once q2w in combination with MTX and folic acid in double-blind period up to Week 24.
47763|NCT02293902|O6|Outcome|Sarilumab Rescue|Participants who received either placebo or sarilumab 150 mg or 200 mg and had inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits (at least 4 weeks apart) in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment up to Week 52.
47764|NCT02293902|O5|Outcome|Placebo/Sarilumab 200 mg|Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
47765|NCT02293902|O4|Outcome|Placebo/Sarilumab 150 mg|Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
47766|NCT02293902|O3|Outcome|Sarilumab 200 mg/200 mg|Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
47767|NCT02293902|O2|Outcome|Sarilumab 150 mg/150 mg|Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
47768|NCT02293902|O1|Outcome|Placebo|Placebo (for sarilumab) SC injection once q2w in combination with MTX and folic acid in double-blind period up to Week 24.
47769|NCT02293902|O6|Outcome|Sarilumab Rescue|Participants who received either placebo or sarilumab 150 mg or 200 mg and had inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits [at least 4 weeks apart] in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment up to Week 52.
47770|NCT02293902|O5|Outcome|Placebo/Sarilumab 200 mg|Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
47771|NCT02293902|O4|Outcome|Placebo/Sarilumab 150 mg|Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
47772|NCT02293902|O3|Outcome|Sarilumab 200 mg/200 mg|Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
47773|NCT02293902|O2|Outcome|Sarilumab 150 mg/150 mg|Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
47774|NCT02293902|O1|Outcome|Placebo|Placebo (for sarilumab) SC injection once q2w in combination with MTX and folic acid in double-blind period up to Week 24.
47775|NCT02293902|O6|Outcome|Sarilumab Rescue|Participants who received either placebo or sarilumab 150 mg or 200 mg and had inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits [at least 4 weeks apart] in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment up to Week 52.
47776|NCT02293902|O5|Outcome|Placebo/Sarilumab 200 mg|Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
47777|NCT02293902|O4|Outcome|Placebo/Sarilumab 150 mg|Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
47778|NCT02293902|O3|Outcome|Sarilumab 200 mg/200 mg|Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
47779|NCT02293902|O2|Outcome|Sarilumab 150 mg/150 mg|Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
47780|NCT02293902|O1|Outcome|Placebo|Placebo (for sarilumab) SC injection once q2w in combination with MTX and folic acid in double-blind period up to Week 24.
47781|NCT02293902|O6|Outcome|Sarilumab Rescue|Participants who received either placebo or sarilumab 150 mg or 200 mg and had inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits [at least 4 weeks apart] in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment up to Week 52.
47782|NCT02293902|O5|Outcome|Placebo/Sarilumab 200 mg|Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
47783|NCT02293902|O4|Outcome|Placebo/Sarilumab 150 mg|Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
47784|NCT02293902|O3|Outcome|Sarilumab 200 mg/200 mg|Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
47785|NCT02293902|O2|Outcome|Sarilumab 150 mg/150 mg|Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
47786|NCT02293902|O1|Outcome|Placebo|Placebo (for sarilumab) SC injection once q2w in combination with MTX and folic acid in double-blind period up to Week 24.
47787|NCT02293902|O3|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
47788|NCT02293902|O2|Outcome|Sarilumab 150 mg|Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
47789|NCT02293902|O1|Outcome|Placebo|Placebo (for sarilumab) SC injection once q2w in combination with MTX and folic acid in double-blind period up to Week 24. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
47790|NCT02293902|E6|Reported Event|Sarilumab Rescue|Participants who received either placebo or sarilumab 150 mg or 200 mg and had inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits (at least 4 weeks apart) in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment up to Week 52.
47791|NCT02293902|E5|Reported Event|Placebo/Sarilumab 200 mg|Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
47792|NCT02293902|E4|Reported Event|Placebo/Sarilumab 150 mg|Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
47793|NCT02293902|E3|Reported Event|Sarilumab 200 mg/200 mg|Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
47794|NCT02293902|E2|Reported Event|Sarilumab 150 mg/150 mg|Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
47795|NCT02293902|E1|Reported Event|Placebo|Placebo (for sarilumab) SC injection once q2w in combination with MTX and folic acid in double-blind period up to Week 24.
47796|NCT02293538|B3|Baseline|Total|Total of all reporting groups
47797|NCT02293538|B2|Baseline|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
47798|NCT02293538|B1|Baseline|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
47799|NCT02293538|P2|Participant Flow|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
47800|NCT02293538|P1|Participant Flow|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
47801|NCT02293538|O2|Outcome|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
47802|NCT02293538|O1|Outcome|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
47803|NCT02293538|O2|Outcome|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
47804|NCT02293538|O1|Outcome|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
47837|NCT02292537|P2|Participant Flow|Nusinersen|Nusinersen 12 mg solution via intrathecal (IT) injection on Days 1, 29, 85 and 274.
47805|NCT02293538|O2|Outcome|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
47806|NCT02293538|O1|Outcome|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
47807|NCT02293538|O1|Outcome|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
47808|NCT02293538|O2|Outcome|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
47809|NCT02293538|O1|Outcome|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
47810|NCT02293538|E2|Reported Event|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
47811|NCT02293538|E1|Reported Event|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
47812|NCT02293395|B3|Baseline|Total|Total of all reporting groups
47813|NCT02293395|B2|Baseline|Acetylsalicylic Acid 100 mg Once Daily (OD)|Participants received oral dose of 100 mg ASA OD and rivaroxaban placebo BID along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.
47814|NCT02293395|B1|Baseline|Rivaroxaban 2.5 mg Twice Daily (BID)|Participants received oral dose of 2.5 mg rivaroxaban BID and acetylsalicylic acid (ASA) placebo once daily (OD) along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.
47815|NCT02293395|P2|Participant Flow|Acetylsalicylic Acid 100 mg Once Daily (OD)|Participants received oral dose of 100 mg ASA OD and rivaroxaban placebo BID along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.
47816|NCT02293395|P1|Participant Flow|Rivaroxaban 2.5 mg Twice Daily (BID)|Participants received oral dose of 2.5 mg rivaroxaban BID and acetylsalicylic acid (ASA) placebo once daily (OD) along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.
47817|NCT02293395|O2|Outcome|Acetylsalicylic Acid 100 mg Once Daily (OD)|Participants received oral dose of 100 mg ASA OD and rivaroxaban placebo BID along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.
47818|NCT02293395|O1|Outcome|Rivaroxaban 2.5 mg Twice Daily (BID)|Participants received oral dose of 2.5 mg rivaroxaban BID and acetylsalicylic acid (ASA) placebo once daily (OD) along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.
47819|NCT02293395|E2|Reported Event|Acetylsalicylic Acid 100 mg Once Daily (OD)|Participants received oral dose of 100 mg ASA OD and rivaroxaban placebo BID along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.
47820|NCT02293395|E1|Reported Event|Rivaroxaban 2.5 mg Twice Daily (BID)|Participants received oral dose of 2.5 mg rivaroxaban BID and acetylsalicylic acid (ASA) placebo once daily (OD) along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.
47821|NCT02292849|B4|Baseline|Total|Total of all reporting groups
47822|NCT02292849|B3|Baseline|Referral Clients|"These individuals will receive a standard mental health referral to a community agency.~Standard Mental Health Referral: Standard mental health referral to a community agency"
47823|NCT02292849|B2|Baseline|Peer to Peer Clients|"These individuals will receive a standard mental health referral to a community agency and in addition meet with a trained peer coach for 12 weekly meetings.~Peer to Peer: 12 weekly sessions of peer-delivered behavioral activation"
47824|NCT02292849|B1|Baseline|Peer to Peer Coaches|These individuals were eligible to provide the Behavioral Activation intervention.
47825|NCT02292849|P3|Participant Flow|Referral Clients|"These individuals will receive a standard mental health referral to a community agency.~Standard Mental Health Referral: Standard mental health referral to a community agency"
47826|NCT02292849|P2|Participant Flow|Peer to Peer Clients|"These individuals will receive a standard mental health referral to a community agency and in addition meet with a trained peer coach for 12 weekly meetings.~Peer to Peer: 12 weekly sessions of peer-delivered behavioral activation"
47827|NCT02292849|P1|Participant Flow|Peer to Peer Coaches|Peer coaches who were eligible to provide the Behavioral Activation intervention
47828|NCT02292849|O2|Outcome|Referral Clients|"These individuals will receive a standard mental health referral to a community agency.~Standard Mental Health Referral: Standard mental health referral to a community agency"
47829|NCT02292849|O1|Outcome|Peer to Peer Clients|"These individuals will receive a standard mental health referral to a community agency and in addition meet with a trained peer coach for 12 weekly meetings.~Peer to Peer: 12 weekly sessions of peer-delivered behavioral activation"
47830|NCT02292849|O1|Outcome|Peer to Peer Clients|Those individuals will receive a standard mental health referral to a community agency and in addition meet with a Peer Coach for 12 weekly meetings.
47831|NCT02292849|O1|Outcome|Peer to Peer Coaches|Peer coaches who were eligible to provide the Behavioral Activation intervention
47832|NCT02292849|E2|Reported Event|Referral Clients|"These individuals will receive a standard mental health referral to a community agency.~Standard Mental Health Referral: Standard mental health referral to a community agency"
47833|NCT02292849|E1|Reported Event|Peer to Peer Clients|"These individuals will receive a standard mental health referral to a community agency and in addition meet with a trained peer coach for 12 weekly meetings.~Peer to Peer: 12 weekly sessions of peer-delivered behavioral activation"
47834|NCT02292537|B3|Baseline|Total|Total of all reporting groups
47835|NCT02292537|B2|Baseline|Nusinersen|Nusinersen 12 mg solution via intrathecal (IT) injection on Days 1, 29, 85 and 274.
47836|NCT02292537|B1|Baseline|Sham Procedure|Sham comparator on Days 1, 29, 85 and 274.
47839|NCT02292537|O2|Outcome|Nusinersen|Nusinersen 12 mg solution via intrathecal (IT) injection on Days 1, 29, 85 and 274.
47840|NCT02292537|O1|Outcome|Sham Procedure|Sham comparator on Days 1, 29, 85 and 274.
47841|NCT02292537|O2|Outcome|Nusinersen|Nusinersen 12 mg solution via intrathecal (IT) injection on Days 1, 29, 85 and 274.
47842|NCT02292537|O1|Outcome|Sham Procedure|Sham comparator on Days 1, 29, 85 and 274.
47843|NCT02292537|O2|Outcome|Nusinersen|Nusinersen 12 mg solution via intrathecal (IT) injection on Days 1, 29, 85 and 274.
47844|NCT02292537|O1|Outcome|Sham Procedure|Sham comparator on Days 1, 29, 85 and 274.
47845|NCT02292537|O2|Outcome|Nusinersen|Nusinersen 12 mg solution via intrathecal (IT) injection on Days 1, 29, 85 and 274.
47846|NCT02292537|O1|Outcome|Sham Procedure|Sham comparator on Days 1, 29, 85 and 274.
47847|NCT02292537|O2|Outcome|Nusinersen|Nusinersen 12 mg solution via intrathecal (IT) injection on Days 1, 29, 85 and 274.
47848|NCT02292537|O1|Outcome|Sham Procedure|Sham comparator on Days 1, 29, 85 and 274.
47849|NCT02292537|O2|Outcome|Nusinersen|Nusinersen 12 mg solution via intrathecal (IT) injection on Days 1, 29, 85 and 274.
47850|NCT02292537|O1|Outcome|Sham Procedure|Sham comparator on Days 1, 29, 85 and 274.
47851|NCT02292537|O2|Outcome|Nusinersen|Nusinersen 12 mg solution via intrathecal (IT) injection on Days 1, 29, 85 and 274.
47852|NCT02292537|O1|Outcome|Sham Procedure|Sham comparator on Days 1, 29, 85 and 274.
47853|NCT02292537|O2|Outcome|Nusinersen|Nusinersen 12 mg solution via intrathecal (IT) injection on Days 1, 29, 85 and 274.
47854|NCT02292537|O1|Outcome|Sham Procedure|Sham comparator on Days 1, 29, 85 and 274.
47855|NCT02292537|O2|Outcome|Nusinersen|Nusinersen 12 mg solution via intrathecal (IT) injection on Days 1, 29, 85 and 274.
47856|NCT02292537|O1|Outcome|Sham Procedure|Sham comparator on Days 1, 29, 85 and 274.
47857|NCT02292537|O2|Outcome|Nusinersen|Nusinersen 12 mg solution via intrathecal (IT) injection on Days 1, 29, 85 and 274.
47858|NCT02292537|O1|Outcome|Sham Procedure|Sham comparator on Days 1, 29, 85 and 274.
47859|NCT02292537|O2|Outcome|Nusinersen|Nusinersen 12 mg solution via intrathecal (IT) injection on Days 1, 29, 85 and 274.
47860|NCT02292537|O1|Outcome|Sham Procedure|Sham comparator on Days 1, 29, 85 and 274.
47861|NCT02292537|O2|Outcome|Nusinersen|Nusinersen 12 mg solution via intrathecal (IT) injection on Days 1, 29, 85 and 274.
47862|NCT02292537|O1|Outcome|Sham Procedure|Sham comparator on Days 1, 29, 85 and 274.
47863|NCT02292537|O2|Outcome|Nusinersen|Nusinersen 12 mg solution via intrathecal (IT) injection on Days 1, 29, 85 and 274.
47864|NCT02292537|O1|Outcome|Sham Procedure|Sham comparator on Days 1, 29, 85 and 274.
47865|NCT02292537|O2|Outcome|Nusinersen|Nusinersen 12 mg solution via intrathecal (IT) injection on Days 1, 29, 85 and 274.
47866|NCT02292537|O1|Outcome|Sham Procedure|Sham comparator on Days 1, 29, 85 and 274.
47867|NCT02292537|O2|Outcome|Nusinersen|Nusinersen 12 mg solution via intrathecal (IT) injection on Days 1, 29, 85 and 274.
47868|NCT02292537|O1|Outcome|Sham Procedure|Sham comparator on Days 1, 29, 85 and 274.
47869|NCT02292537|E2|Reported Event|Nusinersen|Nusinersen 12 mg solution via intrathecal (IT) injection on Days 1, 29, 85 and 274.
47870|NCT02292537|E1|Reported Event|Sham Procedure|Sham comparator on Days 1, 29, 85 and 274.
47871|NCT02292433|B4|Baseline|Total|Total of all reporting groups
47872|NCT02292433|B3|Baseline|Placebo Then PF-04937319 100 mg Then PF-04937319 250 mg|Participants received placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the first intervention period followed by PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the second intervention period, and then PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
47873|NCT02292433|B2|Baseline|PF-04937319 100 mg Then Placebo Then PF-04937319 250 mg|Participants received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the first intervention period followed by placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the second intervention period, and then PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
47874|NCT02292433|B1|Baseline|PF-04937319 100 mg Then PF-04937319 250 mg Then Placebo|Participants received PF-04937319 100 milligram (mg) orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the first intervention period followed by PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the second intervention period, and then placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
47875|NCT02292433|P3|Participant Flow|Placebo Then PF-04937319 100 mg Then PF-04937319 250 mg|Participants received placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the first intervention period followed by PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the second intervention period, and then PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
47898|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
48063|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
47876|NCT02292433|P2|Participant Flow|PF-04937319 100 mg Then Placebo Then PF-04937319 250 mg|Participants received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the first intervention period followed by placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the second intervention period, and then PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
47877|NCT02292433|P1|Participant Flow|PF-04937319 100 mg Then PF-04937319 250 mg Then Placebo|Participants received PF-04937319 100 milligram (mg) orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the first intervention period followed by PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the second intervention period, and then placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
47878|NCT02292433|O3|Outcome|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
47879|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47880|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47881|NCT02292433|O3|Outcome|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
47882|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47883|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47884|NCT02292433|O3|Outcome|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
47885|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47886|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47887|NCT02292433|O3|Outcome|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
47888|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47889|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47890|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47891|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47892|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47893|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47894|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47895|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47896|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47897|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
48002|NCT02291861|O2|Outcome|SD-809 12 mg/Day|SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.
47899|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47900|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47901|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47902|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47903|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47904|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47905|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47906|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47907|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47908|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47909|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47910|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47911|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47912|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47913|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47914|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47915|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47916|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47917|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47918|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47919|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47920|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47921|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47922|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
68286|NCT02151461|O4|Outcome|Control|Day 1-14: 500mg, Day 15-28: 850mg
47923|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47924|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47925|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47926|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47927|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47928|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47929|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47930|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47931|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47932|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47933|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47934|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47935|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47936|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47937|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47938|NCT02292433|O3|Outcome|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
47939|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47940|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47941|NCT02292433|O3|Outcome|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
47942|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47943|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47944|NCT02292433|E3|Reported Event|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
47945|NCT02292433|E2|Reported Event|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
47946|NCT02292433|E1|Reported Event|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
47947|NCT02292212|B1|Baseline|Single Arm|Total 16 weeks, divided to 3 phases, Pre-ViE phase (2W by control device), ViE phase (12W by target device, ViE-21) and Post-ViE phase (2W by control device).
47948|NCT02292212|P1|Participant Flow|Single Arm|Total 16 weeks, divided to 3 periods, Pre-ViE phase (2W by control device), ViE phase (12W by target device, ViE-21) and Post-ViE phase (2W by control device).
47949|NCT02292212|O3|Outcome|Post ViE Phase|Two weeks (six sessions) on the same model control dialyzer used during the pre-ViE phase
47950|NCT02292212|O2|Outcome|ViE Phase|12 weeks (36 sessions) on the ViE-21
47951|NCT02292212|O1|Outcome|Pre-ViE Phase|Two weeks (six sessions) on the control dialyzer
47952|NCT02292212|O3|Outcome|ViE Phase (2)|13th week of dialysis with ViE-21
47953|NCT02292212|O2|Outcome|ViE Phase (1)|Seventh week of dialysis with ViE-21
47954|NCT02292212|O1|Outcome|Pre-ViE Phase|The first week of dialysis with control dialyzer
47955|NCT02292212|O3|Outcome|ViE Phase (2)|13th week of dialysis with ViE-21
47956|NCT02292212|O2|Outcome|ViE Phase (1)|Seventh week of dialysis with ViE-21
47957|NCT02292212|O1|Outcome|Pre-ViE Phase|The first week of dialysis with control dialyzer
47958|NCT02292212|O3|Outcome|ViE Phase (2)|13th week of dialysis with ViE-21
47959|NCT02292212|O2|Outcome|ViE Phase (1)|Seventh week of dialysis with ViE-21
47960|NCT02292212|O1|Outcome|Pre-ViE Phase|The first week of dialysis with control dialyzer
47961|NCT02292212|O3|Outcome|ViE Phase (2)|13th week of dialysis with ViE-21
47962|NCT02292212|O2|Outcome|ViE Phase (1)|Seventh week of dialysis with ViE-21
47963|NCT02292212|O1|Outcome|Pre-ViE Phase|The first week of dialysis with control dialyzer
47964|NCT02292212|O3|Outcome|ViE Phase (2)|13th week of dialysis with ViE-21
47965|NCT02292212|O2|Outcome|ViE Phase (1)|Seventh week of dialysis with ViE-21
47966|NCT02292212|O1|Outcome|Pre-ViE Phase|The first week of dialysis with control dialyzer
47967|NCT02292212|O3|Outcome|ViE Phase (2)|13th week of dialysis with ViE-21
47968|NCT02292212|O2|Outcome|ViE Phase (1)|Seventh week of dialysis with ViE-21
47969|NCT02292212|O1|Outcome|Pre-ViE Phase|The first week of dialysis with control dialyzer
47970|NCT02292212|O3|Outcome|ViE Phase (2)|13th week of dialysis with ViE-21
47971|NCT02292212|O2|Outcome|ViE Phase (1)|Seventh week of dialysis with ViE-21
47972|NCT02292212|O1|Outcome|Pre-ViE Phase|The first week of dialysis with control dialyzer
47973|NCT02292212|O3|Outcome|ViE Phase (2)|13th week of dialysis with ViE-21
47974|NCT02292212|O2|Outcome|ViE Phase (1)|Seventh week of dialysis with ViE-21
47975|NCT02292212|O1|Outcome|Pre-ViE Phase|The first week of dialysis with control dialyzer
47976|NCT02292212|E3|Reported Event|Post-ViE Phase|Two weeks (six sessions) on the same model control dialyzer used during the pre-ViE phase
47977|NCT02292212|E2|Reported Event|ViE Phase|12 weeks (36 sessions) on ViE-21
47978|NCT02292212|E1|Reported Event|Pre-ViE Phase|Two weeks (six sessions) on control dialyzer
47979|NCT02291861|B5|Baseline|Total|Total of all reporting groups
47980|NCT02291861|B4|Baseline|SD-809 36 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.
47981|NCT02291861|B3|Baseline|SD-809 24 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.
47982|NCT02291861|B2|Baseline|SD-809 12 mg/Day|SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.
47983|NCT02291861|B1|Baseline|Placebo|Placebo tablets taken twice daily for 12 weeks.
47984|NCT02291861|P4|Participant Flow|SD-809 36 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.
47985|NCT02291861|P3|Participant Flow|SD-809 24 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.
47986|NCT02291861|P2|Participant Flow|SD-809 12 mg/Day|SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.
47987|NCT02291861|P1|Participant Flow|Placebo|Placebo tablets taken twice daily for 12 weeks.
47988|NCT02291861|O4|Outcome|SD-809 36 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.
47989|NCT02291861|O3|Outcome|SD-809 24 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.
47990|NCT02291861|O2|Outcome|SD-809 12 mg/Day|SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.
47991|NCT02291861|O1|Outcome|Placebo|Placebo tablets taken twice daily for 12 weeks.
47992|NCT02291861|O4|Outcome|SD-809 36 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.
47993|NCT02291861|O3|Outcome|SD-809 24 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.
47994|NCT02291861|O2|Outcome|SD-809 12 mg/Day|SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.
47995|NCT02291861|O1|Outcome|Placebo|Placebo tablets taken twice daily for 12 weeks.
47996|NCT02291861|O4|Outcome|SD-809 36 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.
47997|NCT02291861|O3|Outcome|SD-809 24 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.
47998|NCT02291861|O2|Outcome|SD-809 12 mg/Day|SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.
47999|NCT02291861|O1|Outcome|Placebo|Placebo tablets taken twice daily for 12 weeks.
48000|NCT02291861|O4|Outcome|SD-809 36 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.
48001|NCT02291861|O3|Outcome|SD-809 24 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.
48004|NCT02291861|O4|Outcome|SD-809 36 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.
48005|NCT02291861|O3|Outcome|SD-809 24 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.
48006|NCT02291861|O2|Outcome|SD-809 12 mg/Day|SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.
48007|NCT02291861|O1|Outcome|Placebo|Placebo tablets taken twice daily for 12 weeks.
48008|NCT02291861|O4|Outcome|SD-809 36 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.
48009|NCT02291861|O3|Outcome|SD-809 24 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.
48010|NCT02291861|O2|Outcome|SD-809 12 mg/Day|SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.
48011|NCT02291861|O1|Outcome|Placebo|Placebo tablets taken twice daily for 12 weeks.
48012|NCT02291861|O4|Outcome|SD-809 36 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.
48013|NCT02291861|O3|Outcome|SD-809 24 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.
48014|NCT02291861|O2|Outcome|SD-809 12 mg/Day|SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.
48015|NCT02291861|O1|Outcome|Placebo|Placebo tablets taken twice daily for 12 weeks.
48016|NCT02291861|O4|Outcome|SD-809 36 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.
48017|NCT02291861|O3|Outcome|SD-809 24 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.
48018|NCT02291861|O2|Outcome|SD-809 12 mg/Day|SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.
48019|NCT02291861|O1|Outcome|Placebo|Placebo tablets taken twice daily for 12 weeks.
48020|NCT02291861|E4|Reported Event|SD-809 36 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.
48021|NCT02291861|E3|Reported Event|SD-809 24 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.
48022|NCT02291861|E2|Reported Event|SD-809 12 mg/Day|SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.
48023|NCT02291861|E1|Reported Event|Placebo|Placebo tablets taken twice daily for 12 weeks.
48024|NCT02291718|B4|Baseline|Total|Total of all reporting groups
48025|NCT02291718|B3|Baseline|Isovue 370 (60mL)|60mL Isovue 370 injected 100 kVp, 240 mAs used to obtain CT
48026|NCT02291718|B2|Baseline|Isovue 370 (75mL)|75mL Isovue 370 injected 100 kVp, 250 mAs used for obtaining CT
48027|NCT02291718|B1|Baseline|Isovue 300 (75mL)|75mL Isovue 300 injected 120kvp, 250mAs used to obtain CT scan
48028|NCT02291718|P3|Participant Flow|Isovue 370 (60mL)|60mL Isovue 370 injected 100 kVp, 240 mAs used to obtain CT
48029|NCT02291718|P2|Participant Flow|Isovue 370 (75mL)|75mL Isovue 370 injected 100 kVp, 250 mAs used for obtaining CT
48030|NCT02291718|P1|Participant Flow|Isovue 300 (75mL)|75mL Isovue 300 injected 120kvp, 250mAs used to obtain CT scan
48031|NCT02291718|O3|Outcome|Isovue 370 60mL|"Isovue 370 60mL injected 100 kVp 240 mAs~Isovue: iodine contrast"
48032|NCT02291718|O2|Outcome|Isovue 370 75mL|"Isovue 370 75mL injected 100 kVp 240 mAs~Isovue: iodine contrast"
48033|NCT02291718|O1|Outcome|Isovue 300 75mL|"Isovue 300 75mL injected 120 kVp 250 mAs~Isovue: iodine contrast"
48034|NCT02291718|O3|Outcome|Isovue 370 60mL|"Isovue 370 60mL injected 100 kVp 240 mAs~Isovue: iodine contrast"
48035|NCT02291718|O2|Outcome|Isovue 370 75mL|"Isovue 370 75mL injected 100 kVp 240 mAs~Isovue: iodine contrast"
48036|NCT02291718|O1|Outcome|Isovue 300 75mL|"Isovue 300 75mL injected 120 kVp 250 mAs~Isovue: iodine contrast"
48037|NCT02291718|O3|Outcome|Isovue 370 60mL|"Isovue 370 60mL injected 100 kVp 240 mAs~Isovue: iodine contrast"
48038|NCT02291718|O2|Outcome|Isovue 370 75mL|"Isovue 370 75mL injected 100 kVp 240 mAs~Isovue: iodine contrast"
48039|NCT02291718|O1|Outcome|Isovue 300 75mL|"Isovue 300 75mL injected 120 kVp 250 mAs~Isovue: iodine contrast"
48040|NCT02291718|O3|Outcome|Isovue 370 60mL|"Isovue 370 60mL injected 100 kVp 240 mAs~Isovue: iodine contrast"
48041|NCT02291718|O2|Outcome|Isovue 370 75mL|"Isovue 370 75mL injected 100 kVp 240 mAs~Isovue: iodine contrast"
48042|NCT02291718|O1|Outcome|Isovue 300 75mL|"Isovue 300 75mL injected 120 kVp 250 mAs~Isovue: iodine contrast"
48043|NCT02291718|E3|Reported Event|Isovue 370 (60mL)|60mL Isovue 370 injected 100 kVp, 240 mAs used to obtain CT
48044|NCT02291718|E2|Reported Event|Isovue 370 (75mL)|75mL Isovue 370 injected 100 kVp, 250 mAs used for obtaining CT
48045|NCT02291718|E1|Reported Event|Isovue 300 (75mL)|75mL Isovue 300 injected 120kvp, 250mAs used to obtain CT scan
48046|NCT02291679|B4|Baseline|Total|Total of all reporting groups
48047|NCT02291679|B3|Baseline|145 μg Linaclotide|145 μg oral linaclotide, once daily for 12 weeks
48048|NCT02291679|B2|Baseline|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
48049|NCT02291679|B1|Baseline|Placebo|Matching placebo, once daily for 12 weeks
48050|NCT02291679|P3|Participant Flow|145 μg Linaclotide|145 μg oral linaclotide, once daily for 12 weeks
48051|NCT02291679|P2|Participant Flow|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
48052|NCT02291679|P1|Participant Flow|Placebo|Matching placebo, once daily for 12 weeks
48053|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
48054|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
48055|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
48056|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
48064|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
48065|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
48066|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
48067|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
48068|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
48069|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
48070|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
48071|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
48072|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
48073|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
48074|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
48075|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
48076|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
48077|NCT02291679|E3|Reported Event|145 μg Linaclotide|145 μg oral linaclotide, once daily for 12 weeks
48078|NCT02291679|E2|Reported Event|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
48079|NCT02291679|E1|Reported Event|Placebo|Matching placebo, once daily for 12 weeks
48080|NCT02291510|B5|Baseline|Total|Total of all reporting groups
48081|NCT02291510|B4|Baseline|Sequence 4: DACB|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
48082|NCT02291510|B3|Baseline|Sequence 3: CDBA|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
48083|NCT02291510|B2|Baseline|Sequence 2: BCAD|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
48084|NCT02291510|B1|Baseline|Sequence 1: ABDC|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
48085|NCT02291510|P4|Participant Flow|Sequence 4: DACB|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
48086|NCT02291510|P3|Participant Flow|Sequence 3: CDBA|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
48087|NCT02291510|P2|Participant Flow|Sequence 2: BCAD|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
48088|NCT02291510|P1|Participant Flow|Sequence 1: ABDC|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
48089|NCT02291510|O4|Outcome|2000 mg Met XR QD|"Single dose of 2000 mg Metformin Extended-Release~Met XR: metformin extended-release tablets"
48090|NCT02291510|O3|Outcome|1000 mg Met IR BID|"Two doses of 1000 mg Metformin Immediate-Release~Met IR: metformin immediate-release tablets"
48091|NCT02291510|O2|Outcome|1000 mg Met DR BID|"Two doses of 1000 mg Metformin Delayed-Release~Met DR: metformin delayed-release tablets"
48092|NCT02291510|O1|Outcome|500 mg Met DR BID|"Two doses of 500 mg Metformin Delayed-Release~Met DR: metformin delayed-release tablets"
48093|NCT02291510|O4|Outcome|2000 mg Met XR QD|"Single dose of 2000 mg Metformin Extended-Release~Met XR: metformin extended-release tablets"
48094|NCT02291510|O3|Outcome|1000 mg Met IR BID|"Two doses of 1000 mg Metformin Immediate-Release~Met IR: metformin immediate-release tablets"
48095|NCT02291510|O2|Outcome|1000 mg Met DR BID|"Two doses of 1000 mg Metformin Delayed-Release~Met DR: metformin delayed-release tablets"
48096|NCT02291510|O1|Outcome|500 mg Met DR BID|"Two doses of 500 mg Metformin Delayed-Release~Met DR: metformin delayed-release tablets"
48097|NCT02291510|E4|Reported Event|2000 mg Met XR QD|"Single dose of 2000 mg Metformin Extended-Release~Met XR: metformin extended-release tablets"
48098|NCT02291510|E3|Reported Event|1000 mg Met IR BID|"Two doses of 1000 mg Metformin Immediate-Release~Met IR: metformin immediate-release tablets"
48099|NCT02291510|E2|Reported Event|1000 mg Met DR BID|"Two doses of 1000 mg Metformin Delayed-Release~Met DR: metformin delayed-release tablets"
48100|NCT02291510|E1|Reported Event|500 mg Met DR BID|"Two doses of 500 mg Metformin Delayed-Release~Met DR: metformin delayed-release tablets"
48101|NCT02291419|B3|Baseline|Total|Total of all reporting groups
48102|NCT02291419|B2|Baseline|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
48103|NCT02291419|B1|Baseline|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
48104|NCT02291419|P2|Participant Flow|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
48105|NCT02291419|P1|Participant Flow|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
48106|NCT02291419|O2|Outcome|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
48107|NCT02291419|O1|Outcome|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
48108|NCT02291419|O2|Outcome|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
48109|NCT02291419|O1|Outcome|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
48110|NCT02291419|O2|Outcome|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
48111|NCT02291419|O1|Outcome|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
48112|NCT02291419|O2|Outcome|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
48113|NCT02291419|O1|Outcome|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
48114|NCT02291419|O2|Outcome|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
48115|NCT02291419|O1|Outcome|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
48116|NCT02291419|O2|Outcome|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
48117|NCT02291419|O1|Outcome|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
48118|NCT02291419|E2|Reported Event|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
48119|NCT02291419|E1|Reported Event|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
48120|NCT02291237|B3|Baseline|Total|Total of all reporting groups
48121|NCT02291237|B2|Baseline|Placebo|Placebo to match eleclazine administered orally for up to at least 24 weeks
48122|NCT02291237|B1|Baseline|Eleclazine 30/3/6 mg|Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
48123|NCT02291237|P2|Participant Flow|Placebo|Placebo to match eleclazine administered orally for at least 24 weeks
48124|NCT02291237|P1|Participant Flow|Eleclazine 30/3/6 mg|Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
48125|NCT02291237|O2|Outcome|Placebo|Placebo to match eleclazine administered orally for at least 24 weeks
48126|NCT02291237|O1|Outcome|Eleclazine 30/3/6 mg|Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
48127|NCT02291237|O2|Outcome|Placebo|Placebo to match eleclazine administered orally for at least 24 weeks
48128|NCT02291237|O1|Outcome|Eleclazine 30/3/6 mg|Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
48129|NCT02291237|O2|Outcome|Placebo|Placebo to match eleclazine administered orally for at least 24 weeks
48130|NCT02291237|O1|Outcome|Eleclazine 30/3/6 mg|Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
48131|NCT02291237|O2|Outcome|Placebo|Placebo to match eleclazine administered orally for at least 24 weeks
48132|NCT02291237|O1|Outcome|Eleclazine 30/3/6 mg|Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
48133|NCT02291237|O2|Outcome|Placebo|Placebo to match eleclazine administered orally for at least 24 weeks
48134|NCT02291237|O1|Outcome|Eleclazine 30/3/6 mg|Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
48135|NCT02291237|O2|Outcome|Placebo|Placebo to match eleclazine administered orally for at least 24 weeks
48136|NCT02291237|O1|Outcome|Eleclazine 30/3/6 mg|Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
48137|NCT02291237|E2|Reported Event|Placebo|Placebo to match eleclazine administered orally for at least 24 weeks
48138|NCT02291237|E1|Reported Event|Eleclazine 30/3/6 mg|Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
48139|NCT02290821|B3|Baseline|Total|Total of all reporting groups
48140|NCT02290821|B2|Baseline|Placebo|"Placebo~diclofenac sodium gel 1%"
48141|NCT02290821|B1|Baseline|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1%~diclofenac sodium gel 1%"
48142|NCT02290821|P2|Participant Flow|Placebo|"Placebo~diclofenac sodium gel 1%"
48143|NCT02290821|P1|Participant Flow|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1%~diclofenac sodium gel 1%"
48144|NCT02290821|O2|Outcome|Placebo|"Placebo~diclofenac sodium gel 1%"
48145|NCT02290821|O1|Outcome|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1%~diclofenac sodium gel 1%"
48146|NCT02290821|E2|Reported Event|Placebo|"Placebo~diclofenac sodium gel 1%"
48147|NCT02290821|E1|Reported Event|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1%~diclofenac sodium gel 1%"
48148|NCT02290691|B3|Baseline|Total|Total of all reporting groups
48149|NCT02290691|B2|Baseline|Needle and Syringe|"Subjects will receive a single 0.5mL injection of inactivated Influenza Vaccine in the deltoid region on Day 0.~Influenza Vaccine: Influenza Vaccine"
48150|NCT02290691|B1|Baseline|Needle- Free|"Subjects will receive a single 0.5mL injection of inactivated influenza vaccine in the deltoid region on Day 0.~Influenza Vaccine: Influenza Vaccine"
48151|NCT02290691|P2|Participant Flow|Needle and Syringe|"Subjects will receive a single 0.5mL injection of inactivated Influenza Vaccine in the deltoid region on Day 0.~Influenza Vaccine: Influenza Vaccine"
48152|NCT02290691|P1|Participant Flow|Needle- Free|"Subjects will receive a single 0.5mL injection of inactivated influenza vaccine in the deltoid region on Day 0.~Influenza Vaccine: Influenza Vaccine"
48153|NCT02290691|O2|Outcome|Needle- Free|"Subjects will receive a single 0.5mL injection of inactivated influenza vaccine in the deltoid region on Day 0.~Influenza Vaccine: Influenza Vaccine"
48154|NCT02290691|O1|Outcome|Needle and Syringe|"Subjects will receive a single 0.5mL injection of inactivated Influenza Vaccine in the deltoid region on Day 0.~Influenza Vaccine: Influenza Vaccine"
48155|NCT02290691|O2|Outcome|Needle- Free|"Subjects will receive a single 0.5mL injection of inactivated influenza vaccine in the deltoid region on Day 0.~Influenza Vaccine: Influenza Vaccine"
48156|NCT02290691|O1|Outcome|Needle and Syringe|"Subjects will receive a single 0.5mL injection of inactivated Influenza Vaccine in the deltoid region on Day 0.~Influenza Vaccine: Influenza Vaccine"
48157|NCT02290691|O2|Outcome|Needle- Free|"Subjects will receive a single 0.5mL injection of inactivated influenza vaccine in the deltoid region on Day 0.~Influenza Vaccine: Influenza Vaccine"
48158|NCT02290691|O1|Outcome|Needle and Syringe|"Subjects will receive a single 0.5mL injection of inactivated Influenza Vaccine in the deltoid region on Day 0.~Influenza Vaccine: Influenza Vaccine"
48159|NCT02290691|O2|Outcome|Needle- Free|"Subjects will receive a single 0.5mL injection of inactivated influenza vaccine in the deltoid region on Day 0.~Influenza Vaccine: Influenza Vaccine"
48160|NCT02290691|O1|Outcome|Needle and Syringe|"Subjects will receive a single 0.5mL injection of inactivated Influenza Vaccine in the deltoid region on Day 0.~Influenza Vaccine: Influenza Vaccine"
48161|NCT02290691|O2|Outcome|Needle- Free|"Subjects will receive a single 0.5mL injection of inactivated influenza vaccine in the deltoid region on Day 0.~Influenza Vaccine: Influenza Vaccine"
48162|NCT02290691|O1|Outcome|Needle and Syringe|"Subjects will receive a single 0.5mL injection of inactivated Influenza Vaccine in the deltoid region on Day 0.~Influenza Vaccine: Influenza Vaccine"
48163|NCT02290691|E2|Reported Event|Needle and Syringe|"Subjects will receive a single 0.5mL injection of inactivated Influenza Vaccine in the deltoid region on Day 0.~Influenza Vaccine: Influenza Vaccine"
48164|NCT02290691|E1|Reported Event|Needle- Free|"Subjects will receive a single 0.5mL injection of inactivated influenza vaccine in the deltoid region on Day 0.~Influenza Vaccine: Influenza Vaccine"
48165|NCT02290509|B3|Baseline|Total|Total of all reporting groups
48166|NCT02290509|B2|Baseline|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
48167|NCT02290509|B1|Baseline|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent: Intramuscular injection of study vaccine"
48168|NCT02290509|P2|Participant Flow|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
48169|NCT02290509|P1|Participant Flow|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent: Intramuscular injection of study vaccine"
48170|NCT02290509|O2|Outcome|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
48171|NCT02290509|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent: Intramuscular injection of study vaccine"
48172|NCT02290509|O2|Outcome|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
48173|NCT02290509|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent: Intramuscular injection of study vaccine"
48174|NCT02290509|O2|Outcome|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
48175|NCT02290509|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent: Intramuscular injection of study vaccine"
48176|NCT02290509|O2|Outcome|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
48177|NCT02290509|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent: Intramuscular injection of study vaccine"
48178|NCT02290509|E2|Reported Event|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
48179|NCT02290509|E1|Reported Event|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent: Intramuscular injection of study vaccine"
48180|NCT02289989|B3|Baseline|Total|Total of all reporting groups
48181|NCT02289989|B2|Baseline|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm~Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
48182|NCT02289989|B1|Baseline|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm~Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
48206|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
48183|NCT02289989|P2|Participant Flow|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm~Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
48184|NCT02289989|P1|Participant Flow|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm~Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
48185|NCT02289989|O2|Outcome|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm~Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
48186|NCT02289989|O1|Outcome|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm~Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
48187|NCT02289989|O2|Outcome|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm~Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
48188|NCT02289989|O1|Outcome|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm~Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
48189|NCT02289989|O2|Outcome|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm~Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
48190|NCT02289989|O1|Outcome|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm~Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
48191|NCT02289989|O2|Outcome|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm~Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
48192|NCT02289989|O1|Outcome|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm~Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
48193|NCT02289989|O2|Outcome|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm~Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
48194|NCT02289989|O1|Outcome|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm~Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
48195|NCT02289989|O2|Outcome|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm~Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
48196|NCT02289989|O1|Outcome|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm~Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
48197|NCT02289989|E2|Reported Event|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm~Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
48198|NCT02289989|E1|Reported Event|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm~Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
48199|NCT02289963|B3|Baseline|Total|Total of all reporting groups
48200|NCT02289963|B2|Baseline|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
48201|NCT02289963|B1|Baseline|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
48202|NCT02289963|P2|Participant Flow|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
48203|NCT02289963|P1|Participant Flow|Placebo Q2W|Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
48204|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
48205|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
48207|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
48208|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
48209|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
48210|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
48211|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
48212|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
48213|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
48214|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
48215|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
48216|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
48217|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
48218|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
48219|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
48220|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
48221|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
48222|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
48223|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
48224|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
48225|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
48226|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
48227|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
48228|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
48229|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
48230|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
48231|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
48232|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
48233|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
48234|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
48235|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
48236|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
48237|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
48238|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
48239|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
48240|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
48241|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
48242|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
48243|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
48443|NCT02289469|O1|Outcome|PictureRx|"PictureRx medication history platform~PictureRx medication history platform: Tablet PC-based tool to take more complete and accurate medication history"
48244|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
48245|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
48246|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
48247|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
48248|NCT02289963|E2|Reported Event|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Participants exposed to Alirocumab 75 mg Q2W/up to 150 mg Q2W SC injection added to stable LMT (mean exposure of 24 weeks).
48249|NCT02289963|E1|Reported Event|Placebo Q2W|Participants exposed to Placebo (for Alirocumab) SC injection Q2W added to stable LMT (mean exposure of 23 weeks).
48250|NCT02289833|B3|Baseline|Total|Total of all reporting groups
48251|NCT02289833|B2|Baseline|Cohort IHC3+|Participants with HER2 IHC3-positive (IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48252|NCT02289833|B1|Baseline|Cohort IHC2+|Participants with HER2 IHC2-positive (IHC 2+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48253|NCT02289833|P2|Participant Flow|Cohort IHC3+|Participants with HER2 IHC3-positive (IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48254|NCT02289833|P1|Participant Flow|Cohort IHC2+|Participants with HER2 IHC2-positive (IHC 2+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48255|NCT02289833|O2|Outcome|Cohort IHC3+|Participants with HER2 IHC3-positive (IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48256|NCT02289833|O1|Outcome|Cohort IHC2+|Participants with HER2 IHC2-positive (IHC 2+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48257|NCT02289833|O1|Outcome|Anti-drug Antibody Analysis Group|Participants with HER2 IHC2 or IHC3-positive (IHC 2+ or IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48258|NCT02289833|O1|Outcome|Pharmacokinetic (PK) Analysis Group|Participants with HER2 IHC2 or IHC3-positive (IHC 2+ or IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48259|NCT02289833|O1|Outcome|Pharmacokinetic (PK) Analysis Group|Participants with HER2 IHC2 or IHC3-positive (IHC 2+ or IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48260|NCT02289833|O1|Outcome|Pharmacokinetic (PK) Analysis Group|Participants with HER2 IHC2 or IHC3-positive (IHC 2+ or IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48261|NCT02289833|O1|Outcome|Pharmacokinetic (PK) Analysis Group|Participants with HER2 IHC2 or IHC3-positive (IHC 2+ or IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48262|NCT02289833|O1|Outcome|Pharmacokinetic (PK) Analysis Group|Participants with HER2 IHC2 or IHC3-positive (IHC 2+ or IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48263|NCT02289833|O1|Outcome|Pharmacokinetic (PK) Analysis Group|Participants with HER2 IHC2 or IHC3-positive (IHC 2+ or IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48264|NCT02289833|O2|Outcome|Cohort IHC3+|Participants with HER2 IHC3-positive (IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48265|NCT02289833|O1|Outcome|Cohort IHC2+|Participants with HER2 IHC2-positive (IHC 2+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48266|NCT02289833|O2|Outcome|Cohort IHC3+|Participants with HER2 IHC3-positive (IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48267|NCT02289833|O1|Outcome|Cohort IHC2+|Participants with HER2 IHC2-positive (IHC 2+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48268|NCT02289833|O2|Outcome|Cohort IHC3+|Participants with HER2 IHC3-positive (IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48269|NCT02289833|O1|Outcome|Cohort IHC2+|Participants with HER2 IHC2-positive (IHC 2+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48270|NCT02289833|O2|Outcome|Cohort IHC3+|Participants with HER2 IHC3-positive (IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48271|NCT02289833|O1|Outcome|Cohort IHC2+|Participants with HER2 IHC2-positive (IHC 2+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48272|NCT02289833|O2|Outcome|Cohort IHC3+|Participants with HER2 IHC3-positive (IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48273|NCT02289833|O1|Outcome|Cohort IHC2+|Participants with HER2 IHC2-positive (IHC 2+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48274|NCT02289833|O2|Outcome|Cohort IHC3+|Participants with HER2 IHC3-positive (IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48275|NCT02289833|O1|Outcome|Cohort IHC2+|Participants with HER2 IHC2-positive (IHC 2+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48276|NCT02289833|O2|Outcome|Cohort IHC3+|Participants with HER2 IHC3-positive (IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48277|NCT02289833|O1|Outcome|Cohort IHC2+|Participants with HER2 IHC2-positive (IHC 2+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48278|NCT02289833|O2|Outcome|Cohort IHC3+|Participants with HER2 IHC3-positive (IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48279|NCT02289833|O1|Outcome|Cohort IHC2+|Participants with HER2 IHC2-positive (IHC 2+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48280|NCT02289833|O2|Outcome|Cohort IHC3+|Participants with HER2 IHC3-positive (IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48281|NCT02289833|O1|Outcome|Cohort IHC2+|Participants with HER2 IHC2-positive (IHC 2+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48282|NCT02289833|E2|Reported Event|Cohort IHC3+|Participants with HER2 IHC3-positive (IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48283|NCT02289833|E1|Reported Event|Cohort IHC2+|Participants with HER2 IHC2-positive (IHC 2+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
48284|NCT02289820|B8|Baseline|Total|Total of all reporting groups
48285|NCT02289820|B7|Baseline|MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4|Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
48286|NCT02289820|B6|Baseline|MEDI7510 (120 mcg sF + 5 mcg GLA)+ IIV, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48287|NCT02289820|B5|Baseline|MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48288|NCT02289820|B4|Baseline|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48289|NCT02289820|B3|Baseline|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48290|NCT02289820|B2|Baseline|Inactivated Influenza Vaccine (IIV)|Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
48291|NCT02289820|B1|Baseline|MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1|Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
48292|NCT02289820|P7|Participant Flow|MEDI7510 (120 mcg sF + 5 mcg GLA)+ IIV, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48293|NCT02289820|P6|Participant Flow|MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48294|NCT02289820|P5|Participant Flow|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48295|NCT02289820|P4|Participant Flow|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48296|NCT02289820|P3|Participant Flow|Inactivated Influenza Vaccine (IIV)|Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
48297|NCT02289820|P2|Participant Flow|MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4|Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
48298|NCT02289820|P1|Participant Flow|MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1|Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
48299|NCT02289820|O7|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48300|NCT02289820|O6|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48301|NCT02289820|O5|Outcome|Inactivated Influenza Vaccine (IIV)|Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
48302|NCT02289820|O4|Outcome|MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4|Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
48555|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
48303|NCT02289820|O3|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48304|NCT02289820|O2|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48305|NCT02289820|O1|Outcome|MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1|Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
48306|NCT02289820|O7|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48307|NCT02289820|O6|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48308|NCT02289820|O5|Outcome|Inactivated Influenza Vaccine (IIV)|Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
48309|NCT02289820|O4|Outcome|MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4|Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
48310|NCT02289820|O3|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48311|NCT02289820|O2|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48312|NCT02289820|O1|Outcome|MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1|Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
48313|NCT02289820|O7|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48314|NCT02289820|O6|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48315|NCT02289820|O5|Outcome|Inactivated Influenza Vaccine (IIV)|Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
48316|NCT02289820|O4|Outcome|MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4|Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
48317|NCT02289820|O3|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48318|NCT02289820|O2|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48319|NCT02289820|O1|Outcome|MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1|Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
48320|NCT02289820|O4|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48321|NCT02289820|O3|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48322|NCT02289820|O2|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48323|NCT02289820|O1|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48324|NCT02289820|O7|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48325|NCT02289820|O6|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48326|NCT02289820|O5|Outcome|Inactivated Influenza Vaccine (IIV)|Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
48327|NCT02289820|O4|Outcome|MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4|Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
48328|NCT02289820|O3|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48329|NCT02289820|O2|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48330|NCT02289820|O1|Outcome|MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1|Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
48331|NCT02289820|O7|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48332|NCT02289820|O6|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48333|NCT02289820|O5|Outcome|Inactivated Influenza Vaccine (IIV)|Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
48334|NCT02289820|O4|Outcome|MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4|Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
48335|NCT02289820|O3|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48336|NCT02289820|O2|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48337|NCT02289820|O1|Outcome|MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1|Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
48338|NCT02289820|O7|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48339|NCT02289820|O6|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48340|NCT02289820|O5|Outcome|Inactivated Influenza Vaccine (IIV)|Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
48341|NCT02289820|O4|Outcome|MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4|Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
48342|NCT02289820|O3|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48343|NCT02289820|O2|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48344|NCT02289820|O1|Outcome|MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1|Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
48345|NCT02289820|O7|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48346|NCT02289820|O6|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48347|NCT02289820|O5|Outcome|Inactivated Influenza Vaccine (IIV)|Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
48348|NCT02289820|O4|Outcome|MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4|Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
48349|NCT02289820|O3|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48350|NCT02289820|O2|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48351|NCT02289820|O1|Outcome|MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1|Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
48352|NCT02289820|O7|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48353|NCT02289820|O6|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48354|NCT02289820|O5|Outcome|Inactivated Influenza Vaccine (IIV)|Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
48556|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
48355|NCT02289820|O4|Outcome|MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4|Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
48356|NCT02289820|O3|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48357|NCT02289820|O2|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48358|NCT02289820|O1|Outcome|MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1|Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
48359|NCT02289820|O7|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48360|NCT02289820|O6|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48361|NCT02289820|O5|Outcome|Inactivated Influenza Vaccine (IIV)|Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
48362|NCT02289820|O4|Outcome|MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4|Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
48363|NCT02289820|O3|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48364|NCT02289820|O2|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48365|NCT02289820|O1|Outcome|MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1|Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
48366|NCT02289820|O7|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48367|NCT02289820|O6|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48368|NCT02289820|O5|Outcome|Inactivated Influenza Vaccine (IIV)|Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
48369|NCT02289820|O4|Outcome|MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4|Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
48370|NCT02289820|O3|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48371|NCT02289820|O2|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48372|NCT02289820|O1|Outcome|MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1|Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
48373|NCT02289820|O7|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48374|NCT02289820|O6|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48375|NCT02289820|O5|Outcome|Inactivated Influenza Vaccine (IIV)|Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
48376|NCT02289820|O4|Outcome|MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4|Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
48377|NCT02289820|O3|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48378|NCT02289820|O2|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48379|NCT02289820|O1|Outcome|MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1|Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
48380|NCT02289820|O7|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48381|NCT02289820|O6|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48382|NCT02289820|O5|Outcome|Inactivated Influenza Vaccine (IIV)|Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
48383|NCT02289820|O4|Outcome|MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4|Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
48384|NCT02289820|O3|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48385|NCT02289820|O2|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48386|NCT02289820|O1|Outcome|MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1|Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
48387|NCT02289820|O7|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48388|NCT02289820|O6|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48389|NCT02289820|O5|Outcome|Inactivated Influenza Vaccine (IIV)|Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
48390|NCT02289820|O4|Outcome|MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4|Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
48391|NCT02289820|O3|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48392|NCT02289820|O2|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48393|NCT02289820|O1|Outcome|MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1|Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
48394|NCT02289820|O7|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48395|NCT02289820|O6|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48396|NCT02289820|O5|Outcome|Inactivated Influenza Vaccine (IIV)|Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
48397|NCT02289820|O4|Outcome|MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4|Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
48398|NCT02289820|O3|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48399|NCT02289820|O2|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48400|NCT02289820|O1|Outcome|MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1|Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
48401|NCT02289820|E7|Reported Event|MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4|Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
48402|NCT02289820|E6|Reported Event|MEDI7510 (120 mcg sF + 5 mcg GLA)+ IIV, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48403|NCT02289820|E5|Reported Event|MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48404|NCT02289820|E4|Reported Event|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
48405|NCT02289820|E3|Reported Event|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
48406|NCT02289820|E2|Reported Event|Inactivated Influenza Vaccine (IIV)|Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
48489|NCT02289079|O1|Outcome|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine~liposomal bupivacaine"
48407|NCT02289820|E1|Reported Event|MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1|Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
48408|NCT02289755|B1|Baseline|ALLN-177|ALLN-177 (5 capsules: 7,500 units/meal), 3 times a day with meals, 4 days
48409|NCT02289755|P1|Participant Flow|ALLN-177|ALLN-177 (5 capsules; 7,500 units/meal) by mouth 3 times a day with main meals for 4 consecutive days.
48410|NCT02289755|O1|Outcome|ALLN-177|ALLN-177 (5 capsules: 7,500 units/meal), 3 times a day with meals, 4 days
48411|NCT02289755|O1|Outcome|ALLN-177|ALLN-177 (5 capsules: 7,500 units/meal), 3 times a day with meals, 4 days
48412|NCT02289755|E1|Reported Event|ALLN-177|ALLN-177 (5 capsules: 7,500 units/meal), 3 times a day with meals, 4 days
48413|NCT02289742|B3|Baseline|Total|Total of all reporting groups
48414|NCT02289742|B2|Baseline|Astigmats|Nelfilcon A contact lenses (toric and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours.
48415|NCT02289742|B1|Baseline|Presbyopes|Nelfilcon A contact lenses (multifocal and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours.
48416|NCT02289742|P4|Participant Flow|Astigmats Sphere/Toric|Nelfilcon A sphere contact lenses in Periods 1 and 3, with nelfilcon A toric contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 12 hours.
48417|NCT02289742|P3|Participant Flow|Astigmats Toric/Sphere|Nelfilcon A toric contact lenses in Period 1, followed by nelfilcon A sphere contact lenses in Periods 2 and 3. Each product worn bilaterally (in both eyes) for 12 hours.
48418|NCT02289742|P2|Participant Flow|Presbyopes Sphere/MF|Nelfilcon A sphere contact lenses in Periods 1 and 3, with nelfilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 12 hours.
48419|NCT02289742|P1|Participant Flow|Presbyopes MF/Sphere|Nelfilcon A multifocal contact lenses in Period 1, followed by nelfilcon A sphere contact lenses in Periods 2 and 3. Each product worn bilaterally (in both eyes) for 12 hours.
48420|NCT02289742|O4|Outcome|Astigmats / Sphere|Nelfilcon A spherical contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3
48421|NCT02289742|O3|Outcome|Astigmats / Toric|Nelfilcon A toric contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 ( in a crossover design)
48422|NCT02289742|O2|Outcome|Presbyopes / Sphere|Nelfilcon A spherical contact lenses worn balaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3
48423|NCT02289742|O1|Outcome|Presbyopes / Multifocal|Nelfilcon A multifocal contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or 2
48424|NCT02289742|O4|Outcome|Astigmats / Sphere|Nelfilcon A spherical contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3
48425|NCT02289742|O3|Outcome|Astigmats / Toric|Nelfilcon A toric contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design)
48426|NCT02289742|O2|Outcome|Presbyopes / Sphere|Nelfilcon A spherical contact lenses worn balaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3
48427|NCT02289742|O1|Outcome|Presbyopes / Multifocal|Nelfilcon A multifocal contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or 2
48428|NCT02289742|E7|Reported Event|Astigmats / Sphere Second Exposure|All astigmats exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 3
48429|NCT02289742|E6|Reported Event|Astigmats / Sphere First Exposure|All astigmats exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 as randomized
48430|NCT02289742|E5|Reported Event|Astigmats / Toric|All subjects exposed to nelfilcon A toric contact lenses, worn bilaterally (in both eyes) for 12 hours during Periods 1 or 2 as randomized
48431|NCT02289742|E4|Reported Event|Presbyopes / Sphere Second Exposure|All presbyopes exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 3
48432|NCT02289742|E3|Reported Event|Presbyopes / Sphere First Exposure|All presbyopes exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 as randomized
48433|NCT02289742|E2|Reported Event|Presbyopes / Multifocal|All subjects exposed to nelfilcon A multifocal contact lenses, worn bilaterally (in both eyes) for 12 hours during Periods 1 or 2 as randomized
48434|NCT02289742|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to the initiation of study treatment
48435|NCT02289469|B3|Baseline|Total|Total of all reporting groups
48436|NCT02289469|B2|Baseline|Usual Care|Patients in the usual care group were matched on a 1:1 basis with intervention patients, on the basis of having received care in the same area of the Emergency Department by the same nurse. Their medication information was collected in the usual fashion by interview.
48437|NCT02289469|B1|Baseline|PictureRx|Participants in the intervention group interacted with the PictureRx medication history platform on a tablet computer to provide information about their medications and verify their list of prescribed medications
48438|NCT02289469|P2|Participant Flow|Usual Care|Patients in the usual care group were matched on a 1:1 basis with intervention patients, on the basis of having received care in the same area of the Emergency Department by the same nurse. Their medication information was collected in the usual fashion by interview.
48439|NCT02289469|P1|Participant Flow|PictureRx|Participants in the intervention group interacted with the PictureRx medication history platform on a tablet computer to provide information about their medications and verify their list of prescribed medications
48440|NCT02289469|O2|Outcome|Usual Care|Usual medication history process
48441|NCT02289469|O1|Outcome|PictureRx|"PictureRx medication history platform~PictureRx medication history platform: Tablet PC-based tool to take more complete and accurate medication history"
48442|NCT02289469|O2|Outcome|Usual Care|Usual medication history process
48557|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
48444|NCT02289469|E2|Reported Event|Usual Care|Patients in the usual care group were matched on a 1:1 basis with intervention patients, on the basis of having received care in the same area of the Emergency Department by the same nurse. Their medication information was collected in the usual fashion by interview.
48445|NCT02289469|E1|Reported Event|PictureRx|Participants in the intervention group interacted with the PictureRx medication history platform on a tablet computer to provide information about their medications and verify their list of prescribed medications
48446|NCT02289456|B1|Baseline|(Induction Period) Nab-Paclitaxel and Carboplatin|Participants received 4 cycles of nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle and carboplatin area under the curve (AUC) = 5 mg*min/mL IV on Day 1 of each 21-day cycle for 4 cycles. Participants could begin monotherapy with nab-paclitaxel in the absence of clinical or radiological disease progression.
48447|NCT02289456|P1|Participant Flow|Nab-Paclitaxel and Carboplatin|During the induction period, participants received 4 cycles of nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle and carboplatin area under the curve (AUC) = 5 mg*min/mL IV on Day 1 of each 21-day cycle for 4 cycles. In the absence of clinical or radiological disease progression, participants received monotherapy with nab-paclitaxel 100 mg/m^2 by intravenous infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
48448|NCT02289456|O2|Outcome|Monotherapy Period: Nab-Paclitaxel|Participants received 4 cycles of nab-paclitaxel 100 mg/m^2 by intravenous infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
48449|NCT02289456|O1|Outcome|Induction Period: Nab-Paclitaxel and/or Carboplatin|Participants received 4 cycles of nab-paclitaxel 100 mg/m^2 by intravenous infusion on Days 1 and 8 of each 21-day cycle and carboplatin AUC of 5 mg*min/mL IV on Day 1 of each 21-day cycle for 4 cycles.
48450|NCT02289456|O2|Outcome|Monotherapy Period: Nab-Paclitaxel|Participants received 4 cycles of nab-paclitaxel 100 mg/m^2 by intravenous infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
48451|NCT02289456|O1|Outcome|Induction Period: Nab-Paclitaxel and/or Carboplatin|Participants received 4 cycles of nab-paclitaxel 100 mg/m^2 by intravenous infusion on Days 1 and 8 of each 21-day cycle and carboplatin AUC of 5 mg*min/mL IV on Day 1 of each 21-day cycle for 4 cycles.
48452|NCT02289456|O1|Outcome|Nab-Paclitaxel/Carboplatin Followed by Nab-Paclitaxel|Participants received 4 cycles of nab-paclitaxel 100 mg/m^2 by IV infusion on Days 1 and 8 of each 21-day cycle and carboplatin AUC of 5 mg*min/mL IV on Day 1 of each 21-day cycle for 4 cycles during the Induction Period. In the absence of clinical or radiological disease progression, participants moved into the monotherapy period and received nab-paclitaxel 100 mg/m^2 by IV infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
48453|NCT02289456|O1|Outcome|Nab-Paclitaxel/Carboplatin Followed by Nab-Paclitaxel|Participants received 4 cycles of nab-paclitaxel 100 mg/m^2 by IV infusion on Days 1 and 8 of each 21-day cycle and carboplatin AUC of 5 mg*min/mL IV on Day 1 of each 21-day cycle for 4 cycles during the Induction Period. In the absence of clinical or radiological disease progression, participants moved into the monotherapy period and received nab-paclitaxel 100 mg/m^2 by IV infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
48454|NCT02289456|O1|Outcome|Nab-Paclitaxel/Carboplatin Followed by Nab-Paclitaxel|Participants received 4 cycles of nab-paclitaxel 100 mg/m^2 by IV infusion on Days 1 and 8 of each 21-day cycle and carboplatin AUC of 5 mg*min/mL IV on Day 1 of each 21-day cycle for 4 cycles during the Induction Period. In the absence of clinical or radiological disease progression, participants moved into the monotherapy period and received nab-paclitaxel 100 mg/m^2 by IV infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
48455|NCT02289456|O1|Outcome|Nab-Paclitaxel/Carboplatin Followed by Nab-Paclitaxel|Participants received 4 cycles of nab-paclitaxel 100 mg/m^2 by IV infusion on Days 1 and 8 of each 21-day cycle and carboplatin AUC of 5 mg*min/mL IV on Day 1 of each 21-day cycle for 4 cycles during the Induction Period. In the absence of clinical or radiological disease progression, participants moved into the monotherapy period and received nab-paclitaxel 100 mg/m^2 by IV infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
48456|NCT02289456|O1|Outcome|Nab-Paclitaxel/Carboplatin Followed by Nab-Paclitaxel|Participants received 4 cycles of nab-paclitaxel 100 mg/m^2 by IV infusion on Days 1 and 8 of each 21-day cycle and carboplatin AUC of 5 mg*min/mL IV on Day 1 of each 21-day cycle for 4 cycles during the Induction Period. In the absence of clinical or radiological disease progression, participants moved into the monotherapy period and received nab-paclitaxel 100 mg/m^2 by IV infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
48457|NCT02289456|O1|Outcome|Nab-Paclitaxel/Carboplatin Followed by Nab-Paclitaxel|Participants received 4 cycles of nab-paclitaxel 100 mg/m^2 by IV infusion on Days 1 and 8 of each 21-day cycle and carboplatin AUC of 5 mg*min/mL IV on Day 1 of each 21-day cycle for 4 cycles during the Induction Period. In the absence of clinical or radiological disease progression, participants moved into the monotherapy period and received nab-paclitaxel 100 mg/m^2 by IV infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
48458|NCT02289456|O1|Outcome|Nab-Paclitaxel/Carboplatin Followed by Nab-Paclitaxel|Participants received 4 cycles of nab-paclitaxel 100 mg/m^2 by IV infusion on Days 1 and 8 of each 21-day cycle and carboplatin AUC of 5 mg*min/mL IV on Day 1 of each 21-day cycle for 4 cycles during the Induction Period. In the absence of clinical or radiological disease progression, participants moved into the monotherapy period and received nab-paclitaxel 100 mg/m^2 by IV infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
48459|NCT02289456|O1|Outcome|Nab-Paclitaxel/Carboplatin Followed by Nab-Paclitaxel|Participants received 4 cycles of nab-paclitaxel 100 mg/m^2 by IV infusion on Days 1 and 8 of each 21-day cycle and carboplatin AUC of 5 mg*min/mL IV on Day 1 of each 21-day cycle for 4 cycles during the Induction Period. In the absence of clinical or radiological disease progression, participants moved into the monotherapy period and received nab-paclitaxel 100 mg/m^2 by IV infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
48490|NCT02289079|O2|Outcome|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine~Bupivacaine"
48491|NCT02289079|O1|Outcome|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine~liposomal bupivacaine"
48492|NCT02289079|E2|Reported Event|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine~Bupivacaine"
48460|NCT02289456|O1|Outcome|Nab-Paclitaxel/Carboplatin Followed by Nab-Paclitaxel|Participants received 4 cycles of nab-paclitaxel 100 mg/m^2 by IV infusion on Days 1 and 8 of each 21-day cycle and carboplatin AUC of 5 mg*min/mL IV on Day 1 of each 21-day cycle for 4 cycles during the Induction Period. In the absence of clinical or radiological disease progression, participants moved into the monotherapy period and received nab-paclitaxel 100 mg/m^2 by IV infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
48461|NCT02289456|O1|Outcome|(Induction Period) Nab-Paclitaxel and Carboplatin|Participants received 4 cycles of nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle and carboplatin area under the curve (AUC) = 5 mg*min/mL IV on Day 1 of each 21-day cycle for 4 cycles. Participants could begin monotherapy with nab-paclitaxel in the absence of clinical or radiological disease progression.
48462|NCT02289456|O1|Outcome|(Induction Period) Nab-Paclitaxel and Carboplatin|Participants received 4 cycles of nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle and carboplatin area under the curve (AUC) = 5 mg*min/mL IV on Day 1 of each 21-day cycle for 4 cycles. Participants could begin monotherapy with nab-paclitaxel in the absence of clinical or radiological disease progression.
48463|NCT02289456|E3|Reported Event|Follow-Up Period|Participants who discontinued IP for any reason other than lost to follow-up, entered into a follow-up period; scans were performed based on standard of care. Anti-cancer treatments were collected and participants were followed for survival every 90 days for up to 1 year. Death during follow-up is defined as any death that is more than 28 days post last dose of study drug
48464|NCT02289456|E2|Reported Event|Monotherapy: Nab-Paclitaxel|Participants received nab-paclitaxel 100 mg/m^2 intravenous infusion on Days 1 and 8 of each 21-day cycle
48465|NCT02289456|E1|Reported Event|Induction: Nab-Paclitaxel/Carboplatin|Participant's received nab-paclitaxel 100 mg/m^2 intravenous infusion on Days 1 and 8 of each 21-day cycle and barboplatin AUC = 5 mg*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion
48466|NCT02289105|B3|Baseline|Total|Total of all reporting groups
48467|NCT02289105|B2|Baseline|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
48468|NCT02289105|B1|Baseline|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.~Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
48469|NCT02289105|P2|Participant Flow|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
48470|NCT02289105|P1|Participant Flow|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.~Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
48471|NCT02289105|O2|Outcome|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
48472|NCT02289105|O1|Outcome|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.~Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
48473|NCT02289105|O2|Outcome|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
48474|NCT02289105|O1|Outcome|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.~Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
48475|NCT02289105|O2|Outcome|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
48476|NCT02289105|O1|Outcome|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.~Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
48477|NCT02289105|E2|Reported Event|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
48478|NCT02289105|E1|Reported Event|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.~Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
48479|NCT02289079|B3|Baseline|Total|Total of all reporting groups
48480|NCT02289079|B2|Baseline|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine~Bupivacaine"
48481|NCT02289079|B1|Baseline|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine~liposomal bupivacaine"
48482|NCT02289079|P2|Participant Flow|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine~Bupivacaine"
48483|NCT02289079|P1|Participant Flow|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine~liposomal bupivacaine"
48484|NCT02289079|O2|Outcome|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine~Bupivacaine"
48485|NCT02289079|O1|Outcome|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine~liposomal bupivacaine"
48486|NCT02289079|O2|Outcome|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine~Bupivacaine"
48487|NCT02289079|O1|Outcome|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine~liposomal bupivacaine"
48488|NCT02289079|O2|Outcome|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine~Bupivacaine"
68287|NCT02151461|O3|Outcome|FDC500|Leucine 1100mg +Metformin 500mg
48493|NCT02289079|E1|Reported Event|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine~liposomal bupivacaine"
48494|NCT02288364|B3|Baseline|Total|Total of all reporting groups
48495|NCT02288364|B2|Baseline|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
48496|NCT02288364|B1|Baseline|1% Lidocaine|1% Lidocaine alone.
48497|NCT02288364|P2|Participant Flow|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
48498|NCT02288364|P1|Participant Flow|1% Lidocaine|1% Lidocaine alone.
48499|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
48500|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
48501|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
48502|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
48503|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
48504|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
48505|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
48506|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
48507|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
48508|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
48509|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
48510|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
48511|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
48512|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
48513|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
48514|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
48515|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
48516|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
48517|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
48518|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
48519|NCT02288364|E2|Reported Event|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
48520|NCT02288364|E1|Reported Event|1% Lidocaine|1% Lidocaine alone.
48521|NCT02288312|B4|Baseline|Total|Total of all reporting groups
48522|NCT02288312|B3|Baseline|Sequence C|Period 1 - ESL 800 mg, in fed Period 2 - ESL 800 mg (2x400mg), in fasting Period 3 - ESL 800 mg, in fasting
48523|NCT02288312|B2|Baseline|Sequence B|Period 1 - ESL 800 mg (2x400mg), in fasting Period 2 - ESL 800 mg, in fasting Period 3 - ESL 800 mg, in fed
48524|NCT02288312|B1|Baseline|Sequence A|Period 1 - ESL 800 mg, in fasting Period 2 - ESL 800 mg, in fed Period 3 - ESL 800 mg (2x400mg), in fasting
48525|NCT02288312|P3|Participant Flow|Group C|"Period 1 - ESL 800 mg, in fed (4 days) Period 2 - ESL 800 mg (2x400mg), in fasting (4 days) Period 3 - ESL 800 mg, in fasting (4 days)~Washout periods - 7 days between dosing days"
48526|NCT02288312|P2|Participant Flow|Group B|"Period 1 - ESL 800 mg (2x400mg), in fasting (4 days) Period 2 - ESL 800 mg, in fasting (4 days) Period 3 - ESL 800 mg, in fed (4 days)~Washout periods - 7 days between dosing days"
48527|NCT02288312|P1|Participant Flow|Group A|"Period 1 - ESL 800 mg, in fasting (4 days) Period 2 - ESL 800 mg, in fed (4 days) Period 3 - ESL 800 mg (2x400mg), in fasting (4 days)~Washout periods - 7 days between dosing days"
48528|NCT02288312|O3|Outcome|BIA 2-093 800 mg (2 x 400 mg)|"Tablets 2 x 400 mg. Administration:Oral.~BIA 2-093"
48529|NCT02288312|O2|Outcome|BIA 2-093 800 mg Fed|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
48530|NCT02288312|O1|Outcome|BIA 2-093 800 mg Fasting|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
48531|NCT02288312|O3|Outcome|BIA 2-093 800 mg (2 x 400 mg)|"Tablets 2 x 400 mg. Administration:Oral.~BIA 2-093"
48532|NCT02288312|O2|Outcome|BIA 2-093 800 mg Fed|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
48533|NCT02288312|O1|Outcome|BIA 2-093 800 mg Fasting|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
48534|NCT02288312|O3|Outcome|BIA 2-093 800 mg (2 x 400 mg)|"Tablets 2 x 400 mg. Administration:Oral.~BIA 2-093"
48535|NCT02288312|O2|Outcome|BIA 2-093 800 mg Fed|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
48536|NCT02288312|O1|Outcome|BIA 2-093 800 mg Fasting|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
48537|NCT02288312|O3|Outcome|BIA 2-093 800 mg (2 x 400 mg)|"Tablets 2 x 400 mg. Administration:Oral.~BIA 2-093"
48538|NCT02288312|O2|Outcome|BIA 2-093 800 mg Fed|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
48539|NCT02288312|O1|Outcome|BIA 2-093 800 mg Fasting|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
48540|NCT02288312|E3|Reported Event|BIA 2-093 800 mg (2 x 400 mg)|"Tablets 2 x 400 mg. Administration:Oral.~BIA 2-093"
48541|NCT02288312|E2|Reported Event|BIA 2-093 800 mg Fed|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
48542|NCT02288312|E1|Reported Event|BIA 2-093 800 mg Fasting|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
48543|NCT02288273|B3|Baseline|Total|Total of all reporting groups
48544|NCT02288273|B2|Baseline|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
48545|NCT02288273|B1|Baseline|Once Weekly (EQW) + Met|Bydureon EQW + Metformin XR 1500-2000 mg
48546|NCT02288273|P2|Participant Flow|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
48547|NCT02288273|P1|Participant Flow|Once Weekly (EQW) + Met|Bydureon EQW + Metformin XR 1500-2000 mg
48548|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
48549|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
48550|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
48551|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
48552|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
48553|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
48554|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
68288|NCT02151461|O2|Outcome|FDC250|Leucine 1100mg +Metformin 250mg
48558|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
48559|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
48560|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
48561|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
48562|NCT02288273|E2|Reported Event|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
48563|NCT02288273|E1|Reported Event|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
48564|NCT02288091|B1|Baseline|Open-label|"Subjects will receive oral inosine daily.~Inosine: Twenty-five eligible subjects will receive inosine for 12 weeks (administered in the form of 500 mg capsules, 1 to 6 capsules a day for a total daily dose of up to 3 gm). The dose of inosine will be titrated to target urate levels of 7-8 mg/dL based on urate level measurement that will occur at Week 2, Week 4, Week 6, and Week 9 after Baseline."
48565|NCT02288091|P1|Participant Flow|Open-label|"Subjects will receive oral inosine daily.~Inosine: Twenty-five eligible subjects will receive inosine for 12 weeks (administered in the form of 500 mg capsules, 1 to 6 capsules a day for a total daily dose of up to 3 gm). The dose of inosine will be titrated to target urate levels of 7-8 mg/dL based on urate level measurement that will occur at Week 2, Week 4, Week 6, and Week 9 after Baseline."
48566|NCT02288091|O1|Outcome|Open-label|"Subjects will receive oral inosine daily.~Inosine: Twenty-five eligible subjects will receive inosine for 12 weeks (administered in the form of 500 mg capsules, 1 to 6 capsules a day for a total daily dose of up to 3 gm). The dose of inosine will be titrated to target urate levels of 7-8 mg/dL based on urate level measurement that will occur at Week 2, Week 4, Week 6, and Week 9 after Baseline."
48567|NCT02288091|O1|Outcome|Open-label|"Subjects will receive oral inosine daily.~Inosine: Twenty-five eligible subjects will receive inosine for 12 weeks (administered in the form of 500 mg capsules, 1 to 6 capsules a day for a total daily dose of up to 3 gm). The dose of inosine will be titrated to target urate levels of 7-8 mg/dL based on urate level measurement that will occur at Week 2, Week 4, Week 6, and Week 9 after Baseline."
48568|NCT02288091|O1|Outcome|Open-label|"Subjects will receive oral inosine daily.~Inosine: Twenty-five eligible subjects will receive inosine for 12 weeks (administered in the form of 500 mg capsules, 1 to 6 capsules a day for a total daily dose of up to 3 gm). The dose of inosine will be titrated to target urate levels of 7-8 mg/dL based on urate level measurement that will occur at Week 2, Week 4, Week 6, and Week 9 after Baseline."
48569|NCT02288091|O1|Outcome|Open-label|"Subjects will receive oral inosine daily.~Inosine: Twenty-five eligible subjects will receive inosine for 12 weeks (administered in the form of 500 mg capsules, 1 to 6 capsules a day for a total daily dose of up to 3 gm). The dose of inosine will be titrated to target urate levels of 7-8 mg/dL based on urate level measurement that will occur at Week 2, Week 4, Week 6, and Week 9 after Baseline."
48570|NCT02288091|O1|Outcome|Open-label|"Subjects will receive oral inosine daily.~Inosine: Twenty-five eligible subjects will receive inosine for 12 weeks (administered in the form of 500 mg capsules, 1 to 6 capsules a day for a total daily dose of up to 3 gm). The dose of inosine will be titrated to target urate levels of 7-8 mg/dL based on urate level measurement that will occur at Week 2, Week 4, Week 6, and Week 9 after Baseline."
48571|NCT02288091|E1|Reported Event|Open-label|"Subjects will receive oral inosine daily.~Inosine: Twenty-five eligible subjects will receive inosine for 12 weeks (administered in the form of 500 mg capsules, 1 to 6 capsules a day for a total daily dose of up to 3 gm). The dose of inosine will be titrated to target urate levels of 7-8 mg/dL based on urate level measurement that will occur at Week 2, Week 4, Week 6, and Week 9 after Baseline."
48572|NCT02287883|B3|Baseline|Total|Total of all reporting groups
48573|NCT02287883|B2|Baseline|Patients at Low PAE Practices|Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with low implementation of patient activation and engagement (PAE) activities.
48574|NCT02287883|B1|Baseline|Patients at High PAE Practices|Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with high implementation of patient activation and engagement (PAE) activities.
48575|NCT02287883|P2|Participant Flow|Patients at Low PAE Practices (n=8 Practices)|Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with low implementation of patient activation and engagement (PAE) activities (bottom quartile).
48576|NCT02287883|P1|Participant Flow|Patients at High PAE Practices (n=8 Practices)|Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with high implementation of patient activation and engagement (PAE) activities (top quartile).
48577|NCT02287883|O2|Outcome|Patients at Low PAE Practices|Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with low implementation of patient activation and engagement (PAE) activities.
48578|NCT02287883|O1|Outcome|Patients at High PAE Practices|Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with high implementation of patient activation and engagement (PAE) activities.
48579|NCT02287883|O2|Outcome|Patients at Low PAE Practices|Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with low implementation of patient activation and engagement (PAE) activities.
48580|NCT02287883|O1|Outcome|Patients at High PAE Practices|Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with high implementation of patient activation and engagement (PAE) activities.
48581|NCT02287883|O2|Outcome|Patients at Low PAE Practices|Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with low implementation of patient activation and engagement (PAE) activities.
48582|NCT02287883|O1|Outcome|Patients at High PAE Practices|Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with high implementation of patient activation and engagement (PAE) activities.
48583|NCT02287883|E2|Reported Event|Patients at Low PAE Practices|Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with low implementation of patient activation and engagement (PAE) activities.
48627|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
48584|NCT02287883|E1|Reported Event|Patients at High PAE Practices|Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with high implementation of patient activation and engagement (PAE) activities.
48585|NCT02287779|B9|Baseline|Total|Total of all reporting groups
48586|NCT02287779|B8|Baseline|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
48587|NCT02287779|B7|Baseline|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
48588|NCT02287779|B6|Baseline|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
48589|NCT02287779|B5|Baseline|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
48590|NCT02287779|B4|Baseline|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
48591|NCT02287779|B3|Baseline|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally once a day (QD) for 12 days.
48592|NCT02287779|B2|Baseline|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 milligram (mg) capsule orally twice a day (BID) for 12 days.
48593|NCT02287779|B1|Baseline|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days
48594|NCT02287779|P8|Participant Flow|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
48595|NCT02287779|P7|Participant Flow|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
48596|NCT02287779|P6|Participant Flow|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
48597|NCT02287779|P5|Participant Flow|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
48598|NCT02287779|P4|Participant Flow|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
48599|NCT02287779|P3|Participant Flow|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally once a day (QD) for 12 days.
48600|NCT02287779|P2|Participant Flow|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 milligram (mg) capsule orally twice a day (BID) for 12 days.
48601|NCT02287779|P1|Participant Flow|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
48602|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
48603|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
48604|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
48605|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
48606|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
48607|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally once a day (QD) for 12 days.
48608|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 milligram (mg) capsule orally twice a day (BID) for 12 days.
48609|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
48610|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
48611|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
48612|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
48613|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
48614|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
48615|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
48616|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
48617|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
48618|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
48619|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
48620|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
48621|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
48622|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
48623|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
48624|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
48625|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
48626|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
48628|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
48629|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
48630|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
48631|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
48632|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
48633|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
48634|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
48635|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
48636|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
48637|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
48638|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
48639|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
48640|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
48641|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
48642|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
48643|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
48644|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
48645|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
48646|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
48647|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
48648|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
48649|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
48650|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
48651|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
48652|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
48653|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
48654|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
48655|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
48656|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
48657|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days
48658|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
48659|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
48660|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
48661|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
48662|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
48663|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
48664|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
48665|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
48666|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
48667|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
48668|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
48669|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
48670|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
48671|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
48672|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
48673|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
48674|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
48675|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
48676|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
48677|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
48678|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
48679|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally once a day (QD) for 12 days.
48680|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
48681|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
48682|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
48683|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
48684|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
48685|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
48686|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
48687|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule QD for 12 days.
48688|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
48689|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
48690|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
48691|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
48692|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
48693|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
48694|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
48695|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
48696|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
48697|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
48698|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
48699|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
48700|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
48701|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
48702|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
48703|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule QD for 12 days.
48704|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
48705|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
48706|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
48707|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
48708|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
48709|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
48710|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
48711|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
48712|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
48713|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
48714|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
48715|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
48716|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
48804|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
48717|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
48718|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
48719|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule QD for 12 days.
48720|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
48721|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
48722|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
48723|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
48724|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
48725|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
48726|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
48727|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally once a day (QD) for 12 days.
48728|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 milligram (mg) capsule orally twice a day (BID) for 12 days.
48729|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
48730|NCT02287779|E8|Reported Event|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
48731|NCT02287779|E7|Reported Event|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
48732|NCT02287779|E6|Reported Event|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
48733|NCT02287779|E5|Reported Event|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
48734|NCT02287779|E4|Reported Event|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
48735|NCT02287779|E3|Reported Event|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule QD for 12 days.
48736|NCT02287779|E2|Reported Event|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
48737|NCT02287779|E1|Reported Event|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
48738|NCT02287623|B3|Baseline|Total|Total of all reporting groups
48739|NCT02287623|B2|Baseline|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
48740|NCT02287623|B1|Baseline|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
48741|NCT02287623|P2|Participant Flow|Bupivacaine TAP|Patients will receive a TAP block with bupivacaine bupivacaine: patients will receive a tap with bupivacaine in the preoperative area before the kidney donation. This occurred under ultrasound guidance with the patient sedated. the patient received 30 mL total per tap. Each TAP consisted of 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine.
48742|NCT02287623|P1|Participant Flow|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine in the preoperative area before the kidney donation. This occurred under ultrasound guidance with the patient sedated. the patient received 30 mL total per tap. Each TAP consisted of 10 mL of liposomal bupivacaine and 20 mL of normal saline."
48743|NCT02287623|O2|Outcome|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
48744|NCT02287623|O1|Outcome|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
48745|NCT02287623|O2|Outcome|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
48746|NCT02287623|O1|Outcome|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
48747|NCT02287623|O2|Outcome|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
48748|NCT02287623|O1|Outcome|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
48749|NCT02287623|O2|Outcome|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
48750|NCT02287623|O1|Outcome|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
48751|NCT02287623|O2|Outcome|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
48752|NCT02287623|O1|Outcome|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
48753|NCT02287623|O2|Outcome|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
48754|NCT02287623|O1|Outcome|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
48755|NCT02287623|E2|Reported Event|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
48756|NCT02287623|E1|Reported Event|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
48757|NCT02287610|B1|Baseline|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48758|NCT02287610|P1|Participant Flow|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48759|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48760|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48761|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48762|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48763|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48764|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48765|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48766|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48767|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48768|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48769|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48770|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48771|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48772|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48773|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48774|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48775|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48776|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48777|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48778|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48779|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48780|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48781|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48782|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48783|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48784|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48785|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48786|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48787|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48788|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48789|NCT02287610|E1|Reported Event|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
48790|NCT02287415|B1|Baseline|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin~BIA 2-093~Warfarin"
48791|NCT02287415|P1|Participant Flow|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin~BIA 2-093~Warfarin"
48792|NCT02287415|O1|Outcome|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin~BIA 2-093~Warfarin"
48793|NCT02287415|O1|Outcome|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin~BIA 2-093~Warfarin"
48794|NCT02287415|O1|Outcome|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin~BIA 2-093~Warfarin"
48795|NCT02287415|E1|Reported Event|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin~BIA 2-093~Warfarin"
48796|NCT02287402|B1|Baseline|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
48797|NCT02287402|P1|Participant Flow|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
48798|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
48799|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
48800|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
48801|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
48802|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
48803|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
48805|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
48806|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
48807|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
48808|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
48809|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
48810|NCT02287402|E1|Reported Event|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
48811|NCT02287376|B1|Baseline|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48812|NCT02287376|P1|Participant Flow|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48813|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48814|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48815|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48816|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48817|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48818|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48819|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48820|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48821|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48822|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48823|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48824|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48825|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48826|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48827|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48828|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48829|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48830|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48831|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48832|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48833|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48834|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48835|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48836|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48837|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48838|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48839|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48840|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48841|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48842|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48843|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48844|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48845|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48846|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48847|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48848|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48849|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48850|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48851|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48852|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48853|NCT02287376|E1|Reported Event|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
48854|NCT02287350|B1|Baseline|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48855|NCT02287350|P1|Participant Flow|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48856|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48908|NCT02287025|O1|Outcome|Regorafenib (Stivarga, BAY 73-4506)|Dose(s) 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off
49363|NCT02283827|E2|Reported Event|BIA 2-093 1200 mg|BIA 2-093 - ESL, Eslicarbazepine
48857|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48858|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48859|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48860|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48861|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48862|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48863|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48864|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48865|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48866|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48867|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48868|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48869|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48870|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48871|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48872|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48873|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48874|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48875|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48876|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48877|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48878|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48879|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48880|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48881|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48882|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48883|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48884|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48885|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48886|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48887|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48888|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48889|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48890|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48891|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48892|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48893|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48894|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48895|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48896|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48897|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48898|NCT02287350|E1|Reported Event|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
48899|NCT02287025|B3|Baseline|Total|Total of all reporting groups
48900|NCT02287025|B2|Baseline|Standard of Care|Participants received 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off. Investigators were supported with standard prescribing information.
48901|NCT02287025|B1|Baseline|SMART|Participants received 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off. Investigators were supported with enhanced drug-specific information via an iPad application (SMART).
48902|NCT02287025|P2|Participant Flow|Standard of Care|Investigators were supported with standard prescribing information.
48903|NCT02287025|P1|Participant Flow|SMART|Investigators were supported with enhanced drug-specific information via an iPad application (SMART).
48904|NCT02287025|O1|Outcome|Regorafenib (Stivarga, BAY 73-4506)|Dose(s) 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off
48905|NCT02287025|O1|Outcome|Regorafenib (Stivarga, BAY 73-4506)|Dose(s) 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off
48906|NCT02287025|O1|Outcome|Regorafenib (Stivarga, BAY 73-4506)|Dose(s) 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off
48907|NCT02287025|O1|Outcome|Regorafenib (Stivarga, BAY 73-4506)|Dose(s) 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off
48909|NCT02287025|O1|Outcome|Regorafenib (Stivarga, BAY 73-4506)|Dose(s) 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off
48910|NCT02287025|E1|Reported Event|Regorafenib (Stivarga, BAY 73-4506)|Dose(s) 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off
48911|NCT02286518|B15|Baseline|Total|Total of all reporting groups
48912|NCT02286518|B14|Baseline|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
48913|NCT02286518|B13|Baseline|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
48914|NCT02286518|B12|Baseline|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
48915|NCT02286518|B11|Baseline|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
48916|NCT02286518|B10|Baseline|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
48917|NCT02286518|B9|Baseline|Part 2 Cohort 4: TAK-114 20 mg Fed + TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, once on Day 1, fed state in period 2 (3 days), followed by a 14 day washout period, further followed by TAK-114 20 mg, capsule, orally, once on Day 1 in fasted state in period 1, in healthy Japanese participants.
48918|NCT02286518|B8|Baseline|Part 2- Cohort 4: TAK-114 Fasted + TAK-114Fed|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of Period 1 (3 days), followed by 14 days washout period, followed by TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of Period 2 (3 days), in Japanese participants.
48919|NCT02286518|B7|Baseline|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
48920|NCT02286518|B6|Baseline|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
48921|NCT02286518|B5|Baseline|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
48922|NCT02286518|B4|Baseline|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
48923|NCT02286518|B3|Baseline|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
48924|NCT02286518|B2|Baseline|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
48925|NCT02286518|B1|Baseline|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
48926|NCT02286518|P14|Participant Flow|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
48927|NCT02286518|P13|Participant Flow|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
48928|NCT02286518|P12|Participant Flow|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
48929|NCT02286518|P11|Participant Flow|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
48930|NCT02286518|P10|Participant Flow|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
48931|NCT02286518|P9|Participant Flow|Part 2 Cohort 4: TAK-114 Fed + TAK-114 Fasted|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of Period 2 (3 days), followed by 14 days washout period, followed by TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of Period 2 (3 days), in Japanese participants.
48932|NCT02286518|P8|Participant Flow|Part 2- Cohort 4: TAK-114 Fasted + TAK-114Fed|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of Period 1 (3 days), followed by 14 days washout period, followed by TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of Period 2 (3 days), in Japanese participants.
48933|NCT02286518|P7|Participant Flow|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
48934|NCT02286518|P6|Participant Flow|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
48935|NCT02286518|P5|Participant Flow|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
48936|NCT02286518|P4|Participant Flow|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
48937|NCT02286518|P3|Participant Flow|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
48938|NCT02286518|P2|Participant Flow|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
48939|NCT02286518|P1|Participant Flow|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
48940|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
48941|NCT02286518|O5|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
48942|NCT02286518|O4|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
48943|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
48944|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
48945|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
48946|NCT02286518|O4|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
48947|NCT02286518|O3|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
48948|NCT02286518|O2|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
48949|NCT02286518|O1|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
48950|NCT02286518|O4|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
48951|NCT02286518|O3|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
48952|NCT02286518|O2|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
48953|NCT02286518|O1|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
48954|NCT02286518|O12|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
48955|NCT02286518|O11|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
48956|NCT02286518|O10|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
48957|NCT02286518|O9|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
48958|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
48959|NCT02286518|O7|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
48960|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
48961|NCT02286518|O5|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
48962|NCT02286518|O4|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
48963|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
48964|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
48965|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
48966|NCT02286518|O4|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
48967|NCT02286518|O3|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
48968|NCT02286518|O2|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
48969|NCT02286518|O1|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
48970|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
48971|NCT02286518|O7|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
48972|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
48973|NCT02286518|O5|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
48974|NCT02286518|O4|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
48975|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
48976|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
48977|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
48978|NCT02286518|O12|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
48979|NCT02286518|O11|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
48980|NCT02286518|O10|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
48981|NCT02286518|O9|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
48982|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
48983|NCT02286518|O7|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
48984|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
48985|NCT02286518|O5|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
48986|NCT02286518|O4|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
48987|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
48988|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
48989|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
48990|NCT02286518|O14|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
48991|NCT02286518|O13|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
48992|NCT02286518|O12|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
48993|NCT02286518|O11|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
48994|NCT02286518|O10|Outcome|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
48995|NCT02286518|O9|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
48996|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
48997|NCT02286518|O7|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
48998|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
48999|NCT02286518|O5|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
49000|NCT02286518|O4|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49001|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49002|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49003|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49004|NCT02286518|O4|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49005|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49006|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49007|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49008|NCT02286518|O14|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
49009|NCT02286518|O13|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
49010|NCT02286518|O12|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
49011|NCT02286518|O11|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
49012|NCT02286518|O10|Outcome|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
49013|NCT02286518|O9|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
49014|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
49015|NCT02286518|O7|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
49016|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
49017|NCT02286518|O5|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
49018|NCT02286518|O4|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49019|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49020|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49021|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49022|NCT02286518|O14|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
49023|NCT02286518|O13|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
49024|NCT02286518|O12|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
49025|NCT02286518|O11|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
49026|NCT02286518|O10|Outcome|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
49027|NCT02286518|O9|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
49028|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
49029|NCT02286518|O7|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
49030|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
49031|NCT02286518|O5|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
49032|NCT02286518|O4|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49033|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49034|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49035|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49036|NCT02286518|O14|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
49037|NCT02286518|O13|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
49038|NCT02286518|O12|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
49039|NCT02286518|O11|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
49040|NCT02286518|O10|Outcome|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
49041|NCT02286518|O9|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
49042|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
49043|NCT02286518|O7|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
49044|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
49045|NCT02286518|O5|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
49046|NCT02286518|O4|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49047|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49048|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49049|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49050|NCT02286518|O14|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
49179|NCT02285777|O1|Outcome|MenABCWY Group|Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
49051|NCT02286518|O13|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
49052|NCT02286518|O12|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
49053|NCT02286518|O11|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
49054|NCT02286518|O10|Outcome|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
49055|NCT02286518|O9|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
49056|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
49057|NCT02286518|O7|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
49058|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
49059|NCT02286518|O5|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
49060|NCT02286518|O4|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49061|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49062|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49063|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49064|NCT02286518|E14|Reported Event|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
49065|NCT02286518|E13|Reported Event|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
49066|NCT02286518|E12|Reported Event|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
49067|NCT02286518|E11|Reported Event|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
49068|NCT02286518|E10|Reported Event|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
49069|NCT02286518|E9|Reported Event|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
49070|NCT02286518|E8|Reported Event|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
49071|NCT02286518|E7|Reported Event|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
49072|NCT02286518|E6|Reported Event|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
49073|NCT02286518|E5|Reported Event|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
49074|NCT02286518|E4|Reported Event|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49075|NCT02286518|E3|Reported Event|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49076|NCT02286518|E2|Reported Event|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49077|NCT02286518|E1|Reported Event|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
49078|NCT02286193|B1|Baseline|Patients Presenting to Community Resource Specialist (CRS)|Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals
49079|NCT02286193|P1|Participant Flow|Patients Presenting to Community Resource Specialist (CRS)|Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals
49080|NCT02286193|O1|Outcome|Patients Presenting to Community Resource Specialist (CRS)|Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals
49081|NCT02286193|O1|Outcome|Patients Presenting to Community Liaison|Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals
49082|NCT02286193|E1|Reported Event|Patients Presenting to Community Resource Specialist (CRS)|Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals
49083|NCT02286102|B3|Baseline|Total|Total of all reporting groups
49084|NCT02286102|B2|Baseline|OrthoPAT|"Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.~OrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively"
49205|NCT02284880|E4|Reported Event|800 mg Tablet of ESL (MF)|800 mg tablet of ESL (MF) ESL - Eslicarbazepine acetate, BIA 2-093 MF - Marketed formulation
49085|NCT02286102|B1|Baseline|Constavac|"Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.~Constavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively"
49086|NCT02286102|P2|Participant Flow|OrthoPAT|"Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.~OrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively"
49087|NCT02286102|P1|Participant Flow|Constavac|"Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.~Constavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively"
49088|NCT02286102|O2|Outcome|OrthoPAT|"Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.~OrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively"
49089|NCT02286102|O1|Outcome|Constavac|"Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.~Constavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively"
49090|NCT02286102|O2|Outcome|OrthoPAT|"Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.~OrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively"
49091|NCT02286102|O1|Outcome|Constavac|"Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.~Constavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively"
49092|NCT02286102|O2|Outcome|OrthoPAT|"Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.~OrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively"
49093|NCT02286102|O1|Outcome|Constavac|"Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.~Constavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively"
49094|NCT02286102|E2|Reported Event|Constavac|"Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.~Constavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively"
49095|NCT02286102|E1|Reported Event|OrthoPAT|"Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.~OrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively"
49096|NCT02285998|B3|Baseline|Total|Total of all reporting groups
49097|NCT02285998|B2|Baseline|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
49098|NCT02285998|B1|Baseline|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
49099|NCT02285998|P2|Participant Flow|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
49100|NCT02285998|P1|Participant Flow|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
49101|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
49102|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
49103|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
49104|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
49105|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
49106|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
49107|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
49108|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
49109|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
49110|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
49111|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
49112|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
49113|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
49114|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
49115|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
49116|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
49117|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
49118|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
49119|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
49120|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
49121|NCT02285998|E2|Reported Event|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
49122|NCT02285998|E1|Reported Event|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
49123|NCT02285907|B1|Baseline|All Study Participants|All 21 participants completed all interventions of a randomized cross-over study to compare 400-kcal lunch meals varying in protein quality but matched for either macronutrient or fiber content or serving size. In the macronutrient and fiber–matched comparisons, both lunch meals contained 24-g protein and 2-g fiber, differing only in the type of protein consumed (beef vs. soy). In the serving size–matched comparisons, the lunch meals contained 1 serving of beef (24-g protein/1-g fiber) or 1 serving of soy (14-g protein/5-g fiber). The participants completed 2 testing days per lunch treatment. On the first day, participants completed the 8 hour testing day with repeated blood sampling and appetite questionnaires. During the second testing day, pre- and post-lunch food cue–stimulated fMRI brain scans were completed. Within each treatment, the first and second testing days were separated by 2–7 days. However, there was 7–14 days in between each treatment.
49124|NCT02285907|P1|Participant Flow|All Study Participants|Twenty-four participants signed the consent but two withdrew prior to beginning testing day procedures. One participant was withdrawn due to protocol violations prior to beginning the fourth treatment. All 21 remaining participants completed all interventions of a randomized cross-over study to compare 400-kcal lunch meals varying in protein quality but matched for either macronutrient or fiber content or serving size (Macronutrient and Fiber Matched BEEF, Macronutrient and Fiber Matched SOY, Serving Size Matched BEEF, and Serving Size Matched Soy). The participants completed 2 testing days per lunch treatment. On the first day, participants completed the 8 hour testing day with repeated blood sampling and appetite questionnaires. During the second testing day, pre- and post-lunch food cue–stimulated fMRI brain scans were completed. Within each treatment, the first and second testing days were separated by 2–7 days. However, there was 7–14 days in between each treatment.
49125|NCT02285907|O2|Outcome|Serving Size Matched Beef|The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
49126|NCT02285907|O1|Outcome|Macronutrient and Fiber Matched Beef|The participants will consume the macronutrient and fiber matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef (Cargill, KS). Soy fiber (Nutritional Designs, NY) was added to the BEEF meal to match total final content between meals.The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
49127|NCT02285907|O2|Outcome|Serving Size Matched Soy|The participants will consume the serving size matched SOY lunch on a single testing day. SOY contained 24% protein, 49% CHO, and 24% fat; the SOY meal contained 14 g of textured soy protein concentrate (Boca Foods, WI).
49128|NCT02285907|O1|Outcome|Serving Size Matched Beef|The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
49129|NCT02285907|O4|Outcome|Serving Size Matched Soy|The participants will consume the serving size matched SOY lunch on a single testing day. SOY contained 24% protein, 49% CHO, and 24% fat; the SOY meal contained 14 g of textured soy protein concentrate (Boca Foods, WI).
49130|NCT02285907|O3|Outcome|Serving Size Matched Beef|The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
49131|NCT02285907|O2|Outcome|Macronutrient and Fiber Matched Soy|The participants will consume the macronutrient and fiber matched SOY lunch on a single testing day. SOY contained 33% protein, 43% CHO, and 24% fat; the SOY meal contained 24 g of textured soy protein concentrate (Boca Foods, WI).
49132|NCT02285907|O1|Outcome|Macronutrient and Fiber Matched Beef|The participants will consume the macronutrient and fiber matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef (Cargill, KS). Soy fiber (Nutritional Designs, NY) was added to the BEEF meal to match total final content between meals.The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
49133|NCT02285907|O4|Outcome|Serving Size Matched Soy|The participants will consume the serving size matched SOY lunch on a single testing day. SOY contained 24% protein, 49% CHO, and 24% fat; the SOY meal contained 14 g of textured soy protein concentrate (Boca Foods, WI).
49134|NCT02285907|O3|Outcome|Serving Size Matched Beef|The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
49135|NCT02285907|O2|Outcome|Macronutrient and Fiber Matched Soy|The participants will consume the macronutrient and fiber matched SOY lunch on a single testing day. SOY contained 33% protein, 43% CHO, and 24% fat; the SOY meal contained 24 g of textured soy protein concentrate (Boca Foods, WI).
49136|NCT02285907|O1|Outcome|Macronutrient and Fiber Matched Beef|The participants will consume the macronutrient and fiber matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef (Cargill, KS). Soy fiber (Nutritional Designs, NY) was added to the BEEF meal to match total final content between meals.The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
49137|NCT02285907|O4|Outcome|Serving Size Matched Soy|The participants will consume the serving size matched SOY lunch on a single testing day. SOY contained 24% protein, 49% CHO, and 24% fat; the SOY meal contained 14 g of textured soy protein concentrate (Boca Foods, WI).
49138|NCT02285907|O3|Outcome|Serving Size Matched Beef|The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
49139|NCT02285907|O2|Outcome|Macronutrient and Fiber Matched Soy|The participants will consume the macronutrient and fiber matched SOY lunch on a single testing day. SOY contained 33% protein, 43% CHO, and 24% fat; the SOY meal contained 24 g of textured soy protein concentrate (Boca Foods, WI).
49140|NCT02285907|O1|Outcome|Macronutrient and Fiber Matched Beef|The participants will consume the macronutrient and fiber matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef (Cargill, KS). Soy fiber (Nutritional Designs, NY) was added to the BEEF meal to match total final content between meals.The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
49141|NCT02285907|O4|Outcome|Serving Size Matched Soy|The participants will consume the serving size matched SOY lunch on a single testing day. SOY contained 24% protein, 49% CHO, and 24% fat; the SOY meal contained 14 g of textured soy protein concentrate (Boca Foods, WI).
49142|NCT02285907|O3|Outcome|Serving Size Matched Beef|The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
49143|NCT02285907|O2|Outcome|Macronutrient and Fiber Matched Soy|The participants will consume the macronutrient and fiber matched SOY lunch on a single testing day. SOY contained 33% protein, 43% CHO, and 24% fat; the SOY meal contained 24 g of textured soy protein concentrate (Boca Foods, WI).
49180|NCT02285777|O2|Outcome|MenACWY Group|Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.
49181|NCT02285777|O1|Outcome|MenABCWY Group|Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
49182|NCT02285777|E2|Reported Event|MenACWY Group|Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.
49144|NCT02285907|O1|Outcome|Macronutrient and Fiber Matched Beef|The participants will consume the macronutrient and fiber matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef (Cargill, KS). Soy fiber (Nutritional Designs, NY) was added to the BEEF meal to match total final content between meals.The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
49145|NCT02285907|E4|Reported Event|Serving Size Matched SOY|The participants will consume the serving size matched SOY lunch on a single testing day. SOY contained 24% protein, 49% CHO, and 24% fat; the SOY meal contained 14 g of textured soy protein concentrate (Boca Foods, WI).
49146|NCT02285907|E3|Reported Event|Serving Size Matched BEEF|The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
49147|NCT02285907|E2|Reported Event|Macronutrient and Fiber Matched SOY|The participants will consume the macronutrient and fiber matched SOY lunch on a single testing day. SOY contained 33% protein, 43% CHO, and 24% fat; the SOY meal contained 24 g of textured soy protein concentrate (Boca Foods, WI).
49148|NCT02285907|E1|Reported Event|Macronutrient and Fiber Matched BEEF|The participants will consume the macronutrient and fiber matched SOY lunch on a single testing day. SOY contained 33% protein, 43% CHO, and 24% fat; the SOY meal contained 24 g of textured soy protein concentrate (Boca Foods, WI).
49149|NCT02285777|B3|Baseline|Total|Total of all reporting groups
49150|NCT02285777|B2|Baseline|MenACWY Group|Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.
49151|NCT02285777|B1|Baseline|MenABCWY Group|Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
49152|NCT02285777|P2|Participant Flow|MenACWY Group|Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.
49153|NCT02285777|P1|Participant Flow|MenABCWY Group|Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
49154|NCT02285777|O2|Outcome|MenACWY Group|Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.
49155|NCT02285777|O1|Outcome|MenABCWY Group|Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
49156|NCT02285777|O2|Outcome|MenACWY Group|Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.
49157|NCT02285777|O1|Outcome|MenABCWY Group|Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
49158|NCT02285777|O2|Outcome|MenACWY Group|Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.
49159|NCT02285777|O1|Outcome|MenABCWY Group|Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
49160|NCT02285777|O2|Outcome|MenACWY Group|Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.
49161|NCT02285777|O1|Outcome|MenABCWY Group|Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
49162|NCT02285777|O2|Outcome|MenACWY Group|Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.
49163|NCT02285777|O1|Outcome|MenABCWY Group|Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
49164|NCT02285777|O2|Outcome|MenACWY Group|Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.
49165|NCT02285777|O1|Outcome|MenABCWY Group|Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
49166|NCT02285777|O2|Outcome|MenACWY Group|Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.
49167|NCT02285777|O1|Outcome|MenABCWY Group|Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
49168|NCT02285777|O2|Outcome|MenACWY Group|Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.
49169|NCT02285777|O1|Outcome|MenABCWY Group|Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
49170|NCT02285777|O2|Outcome|MenACWY Group|Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.
49171|NCT02285777|O1|Outcome|MenABCWY Group|Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
49172|NCT02285777|O2|Outcome|MenACWY Group|Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.
49173|NCT02285777|O1|Outcome|MenABCWY Group|Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
49174|NCT02285777|O2|Outcome|MenACWY Group|Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.
49175|NCT02285777|O1|Outcome|MenABCWY Group|Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
49176|NCT02285777|O2|Outcome|MenACWY Group|Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.
49177|NCT02285777|O1|Outcome|MenABCWY Group|Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
49178|NCT02285777|O2|Outcome|MenACWY Group|Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.
49183|NCT02285777|E1|Reported Event|MenABCWY Group|Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
49184|NCT02285270|B1|Baseline|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT~FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
49185|NCT02285270|P1|Participant Flow|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT~FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
49186|NCT02285270|O1|Outcome|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT~FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
49187|NCT02285270|O1|Outcome|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT~FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
49188|NCT02285270|O1|Outcome|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT~FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
49189|NCT02285270|E1|Reported Event|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT~FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
49190|NCT02284880|B3|Baseline|Total|Total of all reporting groups
49191|NCT02284880|B2|Baseline|800 mg BIA 2-093|In Group 2, subjects received randomly on period 1 and period 2, either a single 800 mg tablet of ESL (MF), or a single 800 mg dose of ESL (TBM).
49192|NCT02284880|B1|Baseline|400 mg BIA 2-093|In Group 1, subjects received randomly on period 1 and 2, either a single 400 mg tablet of ESL (MF), or a single 400 mg tablet of ESL (TBM).
49193|NCT02284880|P4|Participant Flow|800 mg BIA 2-093 Group 2|In Group 2, subjects received on period 1 and 2: 400 mg BIA 2-093 ESL: TBM first, then MF
49194|NCT02284880|P3|Participant Flow|800 mg BIA 2-093 Group 1|In Group 1, subjects received on period 1 and 2: 400 mg BIA 2-093 ESL: MF first, then TBM
49195|NCT02284880|P2|Participant Flow|400 mg BIA 2-093 Group 2|In Group 2, subjects received on period 1 and 2: 400 mg BIA 2-093 ESL: TBM first, then MF
49196|NCT02284880|P1|Participant Flow|400 mg BIA 2-093 Group 1|In Group 1, subjects received on period 1 and 2: 400 mg BIA 2-093 ESL: MF first, then TBM
49197|NCT02284880|O2|Outcome|800 mg BIA 2-093|In Group 2, subjects received randomly on period 1 and period 2, either a single 800 mg tablet of ESL (MF), or a single 800 mg dose of ESL (TBM).
49198|NCT02284880|O1|Outcome|400 mg BIA 2-093|In Group 1, subjects received randomly on period 1 and 2, either a single 400 mg tablet of ESL (MF), or a single 400 mg tablet of ESL (TBM).
49199|NCT02284880|O2|Outcome|800 mg BIA 2-093|In Group 2, subjects received randomly on period 1 and period 2, either a single 800 mg tablet of ESL (MF), or a single 800 mg dose of ESL (TBM).
49200|NCT02284880|O1|Outcome|400 mg BIA 2-093|In Group 1, subjects received randomly on period 1 and 2, either a single 400 mg tablet of ESL (MF), or a single 400 mg tablet of ESL (TBM).
49201|NCT02284880|O2|Outcome|800 mg BIA 2-093|In Group 2, subjects received randomly on period 1 and period 2, either a single 800 mg tablet of ESL (MF), or a single 800 mg dose of ESL (TBM).
49202|NCT02284880|O1|Outcome|400 mg BIA 2-093|In Group 1, subjects received randomly on period 1 and 2, either a single 400 mg tablet of ESL (MF), or a single 400 mg tablet of ESL (TBM).
49203|NCT02284880|E6|Reported Event|After Follow-up Visit|After Follow-up visit ESL - Eslicarbazepine acetate, BIA 2-093 MF - Marketed formulation TBM - To be marketed
49204|NCT02284880|E5|Reported Event|800 mg Tablet of ESL (TBM)|800 mg tablet of ESL (TBM) ESL - Eslicarbazepine acetate, BIA 2-093 TBM - To be marketed
49206|NCT02284880|E3|Reported Event|400 mg Tablet of ESL (TBM)|400 mg tablet of ESL (TBM) ESL - Eslicarbazepine acetate, BIA 2-093 TBM - To be marketed
49207|NCT02284880|E2|Reported Event|400 mg Tablet of ESL (MF)|400 mg tablet of ESL (MF) ESL - Eslicarbazepine acetate, BIA 2-093 MF - Marketed formulation
49208|NCT02284880|E1|Reported Event|Before Treatment|Before treatment with ESL ESL - Eslicarbazepine acetate, BIA 2-093
49209|NCT02284867|B3|Baseline|Total|Total of all reporting groups
49210|NCT02284867|B2|Baseline|Term Labor|"Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
49211|NCT02284867|B1|Baseline|Preterm Labor|"Patients who has threatened preterm labor and will receive tocolysis and these patients will either not respond to tocolysis and delivered preterm or will respond to tocolysis and will deliver at term .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
49212|NCT02284867|P2|Participant Flow|Term Labor|"Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
49213|NCT02284867|P1|Participant Flow|Preterm Labor|"Patients who has threatened preterm labor and will receive tocolysis and these patients will either not respond to tocolysis and delivered preterm or will respond to tocolysis and will deliver at term .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
49214|NCT02284867|O2|Outcome|Term Labor|"Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
49215|NCT02284867|O1|Outcome|Preterm Labor|"Patients who has threatened preterm labor and will receive tocolysis and these patients will either not respond to tocolysis and delivered preterm or will respond to tocolysis and will deliver at term .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
49216|NCT02284867|O2|Outcome|Term Labor|"Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
49217|NCT02284867|O1|Outcome|Preterm Labor|"Patients who has threatened preterm labor and will receive tocolysis and these patients will either not respond to tocolysis and delivered preterm or will respond to tocolysis and will deliver at term .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
68289|NCT02151461|O1|Outcome|FDC125|Leucine 1100mg +Metformin 125mg
49218|NCT02284867|E2|Reported Event|Term Labor|"Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
49219|NCT02284867|E1|Reported Event|Preterm Labor|"Patients who has threatened preterm labor and will receive tocolysis and these patients will either not respond to tocolysis and delivered preterm or will respond to tocolysis and will deliver at term .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
49220|NCT02284854|B3|Baseline|Total|Total of all reporting groups
49221|NCT02284854|B2|Baseline|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + 400 mg twice-daily
49222|NCT02284854|B1|Baseline|Group A|Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
49223|NCT02284854|P2|Participant Flow|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
49224|NCT02284854|P1|Participant Flow|Group A|Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
49225|NCT02284854|O1|Outcome|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
49226|NCT02284854|O1|Outcome|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
49227|NCT02284854|O1|Outcome|Group A|Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
49228|NCT02284854|O1|Outcome|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
49229|NCT02284854|O1|Outcome|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
49230|NCT02284854|O1|Outcome|Group A|Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
49231|NCT02284854|E9|Reported Event|After Treatment|Group A and B After treatment
49232|NCT02284854|E8|Reported Event|Before Treatment|Group A and B Before treatment
49233|NCT02284854|E7|Reported Event|ESL 800 mg + CBZ 400 mg|Group A ESL 800 mg + CBZ 400 mg
49234|NCT02284854|E6|Reported Event|ESL 800 mg + CBZ 200 mg|Group A ESL 800 mg + CBZ 200 mg
49235|NCT02284854|E5|Reported Event|ESL 800 mg|Group A ESL 800 mg
49236|NCT02284854|E4|Reported Event|ESL 800 mg + CBZ 400 mg Twice-daily|Group A + B ESL 800 mg + CBZ 400 mg twice-daily
49237|NCT02284854|E3|Reported Event|CBZ 400 mg Twice-daily|Group B CBZ 400 mg twice-daily
49238|NCT02284854|E2|Reported Event|CBZ 400 mg|Group B CBZ 400 mg
49239|NCT02284854|E1|Reported Event|CBZ 200 mg|Group B CBZ 200 mg
49240|NCT02284828|B1|Baseline|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
49241|NCT02284828|P1|Participant Flow|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
49242|NCT02284828|O1|Outcome|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
49243|NCT02284828|O1|Outcome|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
49244|NCT02284828|O1|Outcome|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
49245|NCT02284828|O1|Outcome|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
49246|NCT02284828|O1|Outcome|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
49247|NCT02284828|O1|Outcome|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
49248|NCT02284828|E4|Reported Event|BIA 2-093 1200 mg|BIA 2-093 - ESL, Eslicarbazepine acetate
49249|NCT02284828|E3|Reported Event|BIA 2-093 800 mg|BIA 2-093 - ESL, Eslicarbazepine acetate
49250|NCT02284828|E2|Reported Event|Placebo|Placebo, PLC
49251|NCT02284828|E1|Reported Event|BIA 2-093 900 mg|BIA 2-093 - ESL, Eslicarbazepine acetate
49252|NCT02284555|B1|Baseline|Mupirocin 2% Nasal Ointment|"Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC).~Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC."
49323|NCT02284165|O1|Outcome|All Patients|Examined descriptively for all patients in the study in order to differentiate the different types of rehabilitation services for the full stroke patient population.
68290|NCT02151461|O4|Outcome|Control|Day 1-14: 500mg, Day 15-28: 850mg
49253|NCT02284555|P1|Participant Flow|Mupirocin 2% Nasal Ointment|"Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC).~Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC."
49254|NCT02284555|O1|Outcome|Mupirocin 2% Nasal Ointment|"Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC).~Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC."
49255|NCT02284555|O1|Outcome|Mupirocin 2% Nasal Ointment|"Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC).~Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC."
49256|NCT02284555|E1|Reported Event|Mupirocin 2% Nasal Ointment|"Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC).~Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC."
49257|NCT02284516|B3|Baseline|Total|Total of all reporting groups
49258|NCT02284516|B2|Baseline|Lifitegrast|Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
49259|NCT02284516|B1|Baseline|Placebo|Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
49260|NCT02284516|P2|Participant Flow|Lifitegrast|Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
49261|NCT02284516|P1|Participant Flow|Placebo|Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
49262|NCT02284516|O2|Outcome|Lifitegrast|Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
49263|NCT02284516|O1|Outcome|Placebo|Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
49264|NCT02284516|O2|Outcome|Lifitegrast|Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
49265|NCT02284516|O1|Outcome|Placebo|Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
49266|NCT02284516|E2|Reported Event|Lifitegrast|Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
49267|NCT02284516|E1|Reported Event|Placebo|Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
49268|NCT02284386|B1|Baseline|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
49269|NCT02284386|P1|Participant Flow|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
49270|NCT02284386|O1|Outcome|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
49271|NCT02284386|O1|Outcome|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
49272|NCT02284386|O1|Outcome|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
49273|NCT02284386|O1|Outcome|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
49274|NCT02284386|O1|Outcome|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
49275|NCT02284386|O1|Outcome|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
49276|NCT02284386|E1|Reported Event|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
49277|NCT02284347|B1|Baseline|NuVent™|"Revision patients treated with NuVent™~Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
68291|NCT02151461|O3|Outcome|FDC500|Leucine 1100mg +Metformin 500mg
49278|NCT02284347|P1|Participant Flow|NuVent™|"Revision patients treated with NuVent™~Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
49279|NCT02284347|O1|Outcome|NuVent™|"Revision patients treated with NuVent™~Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
49280|NCT02284347|O1|Outcome|NuVent™|"Revision patients treated with NuVent™~Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
49281|NCT02284347|O1|Outcome|NuVent™|"Revision patients treated with NuVent™~Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
49282|NCT02284347|E1|Reported Event|NuVent™|"Revision patients treated with NuVent™~Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
49283|NCT02284243|B3|Baseline|Total|Total of all reporting groups
49284|NCT02284243|B2|Baseline|IN Placebo|"IN Placebo every 6 hours for 48 hours.~Intranasal Placebo"
49285|NCT02284243|B1|Baseline|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.~Intranasal Dexmedetomidine"
49286|NCT02284243|P2|Participant Flow|IN Placebo|"IN Placebo every 6 hours for 48 hours.~Intranasal Placebo"
49287|NCT02284243|P1|Participant Flow|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.~Intranasal Dexmedetomidine"
49288|NCT02284243|O2|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours.~Intranasal Placebo"
49289|NCT02284243|O1|Outcome|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.~Intranasal Dexmedetomidine"
49290|NCT02284243|O2|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours.~Intranasal Placebo"
49291|NCT02284243|O1|Outcome|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.~Intranasal Dexmedetomidine"
49292|NCT02284243|O2|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours.~Intranasal Placebo"
49293|NCT02284243|O1|Outcome|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.~Intranasal Dexmedetomidine"
49294|NCT02284243|O2|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours.~Intranasal Placebo"
49295|NCT02284243|O1|Outcome|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.~Intranasal Dexmedetomidine"
49296|NCT02284243|O2|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours.~Intranasal Placebo"
49297|NCT02284243|O1|Outcome|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.~Intranasal Dexmedetomidine"
49298|NCT02284243|O2|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours.~Intranasal Placebo"
49299|NCT02284243|O1|Outcome|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.~Intranasal Dexmedetomidine"
49300|NCT02284243|O2|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours.~Intranasal Placebo"
49301|NCT02284243|O1|Outcome|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.~Intranasal Dexmedetomidine"
49302|NCT02284243|E2|Reported Event|IN Placebo|"IN Placebo every 6 hours for 48 hours.~Intranasal Placebo"
49303|NCT02284243|E1|Reported Event|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.~Intranasal Dexmedetomidine"
49304|NCT02284165|B4|Baseline|Total|Total of all reporting groups
49305|NCT02284165|B3|Baseline|Discharged Home|Discharged from hospital to home with or without services
49306|NCT02284165|B2|Baseline|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
49307|NCT02284165|B1|Baseline|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
49308|NCT02284165|P3|Participant Flow|Discharged Home|Discharged from hospital to home with or without services
49309|NCT02284165|P2|Participant Flow|Skilled Nursing Facility (SNF)|Discharged from hospital to skilled nursing facility
49310|NCT02284165|P1|Participant Flow|Inpatient Rehab Facility (IRF)|Discharged from hospital to inpatient rehabilitation facility
49311|NCT02284165|O2|Outcome|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
49312|NCT02284165|O1|Outcome|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
49313|NCT02284165|O2|Outcome|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
49314|NCT02284165|O1|Outcome|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
49315|NCT02284165|O2|Outcome|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
49316|NCT02284165|O1|Outcome|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
49317|NCT02284165|O2|Outcome|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
49318|NCT02284165|O1|Outcome|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
49319|NCT02284165|O2|Outcome|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
49320|NCT02284165|O1|Outcome|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
49321|NCT02284165|O2|Outcome|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
49322|NCT02284165|O1|Outcome|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
49324|NCT02284165|E1|Reported Event|All Patients|Not applicable. This was a retrospective analysis of pre-existing data for acute ischemic stroke patients in the Get With the Guidelines registry with 12-month follow-up as part of the Adherence Evaluation After Ischemic Stroke Longitudinal (AVAIL) registry.
49325|NCT02283840|B4|Baseline|Total|Total of all reporting groups
49326|NCT02283840|B3|Baseline|Cohort C:BIA 2-093 800 mg|"One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
49327|NCT02283840|B2|Baseline|Cohort B:BIA 2-093 600 mg|"One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
49328|NCT02283840|B1|Baseline|Cohort A:BIA 2-093 400 mg|"One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
49329|NCT02283840|P3|Participant Flow|Cohort C:BIA 2-093 800 mg|"One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
49330|NCT02283840|P2|Participant Flow|Cohort B:BIA 2-093 600 mg|"One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
49331|NCT02283840|P1|Participant Flow|Cohort A:BIA 2-093 400 mg|"One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
49332|NCT02283840|O3|Outcome|Cohort C:BIA 2-093 800 mg|"One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
49333|NCT02283840|O2|Outcome|Cohort B:BIA 2-093 600 mg|"One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
49334|NCT02283840|O1|Outcome|Cohort A:BIA 2-093 400 mg|"One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
49335|NCT02283840|O3|Outcome|Cohort C:BIA 2-093 800 mg|"One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
49336|NCT02283840|O2|Outcome|Cohort B:BIA 2-093 600 mg|"One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
49337|NCT02283840|O1|Outcome|Cohort A:BIA 2-093 400 mg|"One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
49338|NCT02283840|O3|Outcome|Cohort C:BIA 2-093 800 mg|"One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
49339|NCT02283840|O2|Outcome|Cohort B:BIA 2-093 600 mg|"One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
49340|NCT02283840|O1|Outcome|Cohort A:BIA 2-093 400 mg|"One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
49341|NCT02283840|E6|Reported Event|Reference 3|One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)
49342|NCT02283840|E5|Reported Event|Reference 2|One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)
49343|NCT02283840|E4|Reported Event|Reference 1|One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)
49344|NCT02283840|E3|Reported Event|Test 3|One Eslicarbazepine acetate (BIA 2-093) 800 mg To-Be-Marketed Formulation, TBM
49345|NCT02283840|E2|Reported Event|Test 2|One Eslicarbazepine acetate (BIA 2-093) 600 mg To-Be-Marketed Formulation, TBM
49346|NCT02283840|E1|Reported Event|Test 1|One Eslicarbazepine acetate (BIA 2-093) 400 mg To-Be-Marketed Formulation, TBM
49347|NCT02283827|B3|Baseline|Total|Total of all reporting groups
49348|NCT02283827|B2|Baseline|Group B BIA 2-093 + Phenytoin (PHT)|Pre-treatment: 100 mg PHT for 2 days; Treatment 1: 300 mg PHT 6 days; Treatment 2: 600 mg ESL + PHT 300 mg for 2 days; Treatment 3: 1200 mg ESL and PHT 300 mg for 17 days
49349|NCT02283827|B1|Baseline|Group A BIA 2-093 + Phenytoin (PHT)|Pre-treatment: 600 mg ESL, 2 days; Treatment 1: 1200 mg ESL 6 days Treatment 2: 1200 mg ESL and PHT 100 mg for 2 days Treatment 3: 1200 mg ESL and PHT 300 mg for17 days
49350|NCT02283827|P2|Participant Flow|Group B BIA 2-093 + Phenytoin (PHT)|"Day 1 to 2: Pre-treatment 2: PHT 100 mg Day 3 to 8: Treatment 2: PHT 300 mg Day 9 to 10: Treatment 2 + Pre-treatment 1: PHT 300 mg~+ ESL 600 mg Day 11 to 27: Treatment 1 + Treatment 2: 1200 mg ESL + PHT 300 mg"
49351|NCT02283827|P1|Participant Flow|Group A BIA 2-093 + Phenytoin (PHT)|Day 1 to 2: Pre-treatment 1: ESL 600 mg Day 3 to 8: Treatment 1:1200 mg ESL Day 9 to 10: Treatment 1 + Pre-treatment 2: 1200 mg ESL+ PHT 100 mg Day 11 to 27: Treatment 1 + Treatment 2: 1200 mg ESL + PHT 300 mg
49352|NCT02283827|O2|Outcome|BIA 2-093|BIA 2-093 - ESL, Eslicarbazepine
49353|NCT02283827|O1|Outcome|BIA 2-093 + Phenytoin (PHT)|Phenytoin - PHT BIA 2-093 - ESL, Eslicarbazepine
49354|NCT02283827|O2|Outcome|BIA 2-093|BIA 2-093 - ESL, Eslicarbazepine
49355|NCT02283827|O1|Outcome|BIA 2-093 + Phenytoin (PHT)|Phenytoin - PHT BIA 2-093 - ESL, Eslicarbazepine
49356|NCT02283827|O2|Outcome|BIA 2-093|BIA 2-093 - ESL, Eslicarbazepine
49357|NCT02283827|O1|Outcome|BIA 2-093 + Phenytoin|Phenytoin - PHT; BIA 2-093 - ESL, Eslicarbazepine
49358|NCT02283827|E7|Reported Event|BIA 2-093 600 mg + Phenytoin 300 mg|Phenytoin - PHT BIA 2-093 - ESL, Eslicarbazepine
49359|NCT02283827|E6|Reported Event|Phenytoin 300 mg|Phenytoin - PHT 300 mg
49360|NCT02283827|E5|Reported Event|Phenytoin 100 mg|Phenytoin - PHT 100 mg
49361|NCT02283827|E4|Reported Event|BIA 2-093 1200 mg + Phenytoin 300 mg|Phenytoin - PHT BIA 2-093 - ESL, Eslicarbazepine
49362|NCT02283827|E3|Reported Event|BIA 2-093 1200 mg + Phenytoin 100 mg|Phenytoin - PHT BIA 2-093 - ESL, Eslicarbazepine
49364|NCT02283827|E1|Reported Event|BIA 2-093 600 mg|BIA 2-093 - ESL, Eslicarbazepine
49365|NCT02283814|B3|Baseline|Total|Total of all reporting groups
49366|NCT02283814|B2|Baseline|Group B BIA 2-093 + Topamax|"Pre-treatment: 100 mg once daily dose of TPM administered for two consecutive days;~Pre-treatment 2: 100 mg twice daily dose of TPM administered for two consecutive days;~Treatment: 200 mg once daily dose of TPM administered for four consecutive days;~Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 600 mg and TPM 200 mg for two consecutive days~Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200mg for seventeen consecutive days~BIA 2-093~Topamax"
49367|NCT02283814|B1|Baseline|Group A BIA 2-093 + Topamax|"Group A~Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days;~Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days~Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg for two consecutive days~Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg (morning) + 100mg (evening) for two consecutive days~Treatment 4: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200 mg for fifteen consecutive days~BIA 2-093~Topamax"
49368|NCT02283814|P2|Participant Flow|Group B BIA 2-093 + Topamax|"Pre-treatment: 100 mg once daily dose of TPM administered for two consecutive days;~Pre-treatment 2: 100 mg twice daily dose of TPM administered for two consecutive days;~Treatment: 200 mg once daily dose of TPM administered for four consecutive days;~Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 600 mg and TPM 200 mg for two consecutive days~Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200mg for seventeen consecutive days~BIA 2-093~Topamax"
49369|NCT02283814|P1|Participant Flow|Group A BIA 2-093 + Topamax|"Group A~Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days;~Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days~Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg for two consecutive days~Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg (morning) + 100mg (evening) for two consecutive days~Treatment 4: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200 mg for fifteen consecutive days~BIA 2-093~Topamax"
49370|NCT02283814|O2|Outcome|BIA 2-093|BIA 2-093 - ESL; Eslicarbazepine acetate
49371|NCT02283814|O1|Outcome|BIA 2-093 + TPM|BIA 2-093 - ESL; Eslicarbazepine acetate TPM - Topamax
49372|NCT02283814|O2|Outcome|BIA 2-093|BIA 2-093 - ESL; Eslicarbazepine acetate
49373|NCT02283814|O1|Outcome|BIA 2-093 + TPM|BIA 2-093 - ESL; Eslicarbazepine acetate TPM - Topamax
49374|NCT02283814|O2|Outcome|BIA 2-093|BIA 2-093 - ESL; Eslicarbazepine acetate
49375|NCT02283814|O1|Outcome|BIA 2-093 + TPM|BIA 2-093 - ESL; Eslicarbazepine acetate TPM - Topamax
49376|NCT02283814|E2|Reported Event|Group B BIA 2-093 + Topamax|"Pre-treatment: 100 mg once daily dose of TPM administered for two consecutive days;~Pre-treatment 2: 100 mg twice daily dose of TPM administered for two consecutive days;~Treatment: 200 mg once daily dose of TPM administered for four consecutive days;~Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 600 mg and TPM 200 mg for two consecutive days~Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200mg for seventeen consecutive days~BIA 2-093~Topamax"
49377|NCT02283814|E1|Reported Event|Group A BIA 2-093 + Topamax|"Group A~Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days;~Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days~Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg for two consecutive days~Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg (morning) + 100mg (evening) for two consecutive days~Treatment 4: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200 mg for fifteen consecutive days~BIA 2-093~Topamax"
49378|NCT02283788|B5|Baseline|Total|Total of all reporting groups
49379|NCT02283788|B4|Baseline|Treatment Sequence DCBA|"A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days~BIA 2-093~Moxifloxacin~Placebo"
49380|NCT02283788|B3|Baseline|Treatment Sequence CADB|"A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days~BIA 2-093~Moxifloxacin~Placebo"
49381|NCT02283788|B2|Baseline|Treatment Sequence BDAC|"A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days~BIA 2-093~Moxifloxacin~Placebo"
49382|NCT02283788|B1|Baseline|Treatment Sequence ABCD|"A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days~BIA 2-093~Moxifloxacin~Placebo"
49383|NCT02283788|P4|Participant Flow|Group D|Period 1 - placebo once daily × 5 days Period 2 - Moxifloxacin 400 mg × 1 dose Period 3 - BIA 2-093 2400 mg once daily × 5 days Period 4 - BIA 2-093 1200 mg once daily × 5 days
49384|NCT02283788|P3|Participant Flow|Group C|Period 1 - Moxifloxacin 400 mg × 1 dose Period 2 - BIA 2-093 1200 mg once daily × 5 days Period 3 - placebo once daily × 5 days Period 4 - BIA 2-093 2400 mg once daily × 5 days
49385|NCT02283788|P2|Participant Flow|Group B|Period 1 - BIA 2-093 2400 mg once daily × 5 days Period 2 - placebo once daily × 5 days Period 3 - BIA 2-093 1200 mg once daily × 5 days Period 4 - Moxifloxacin 400 mg × 1 dose
49386|NCT02283788|P1|Participant Flow|Group A|Period 1 - BIA 2-093 1200 mg once daily × 5 days Period 2 - BIA 2-093 2400 mg once daily × 5 days Period 3 - Moxifloxacin 400 mg × 1 dose Period 4 - placebo once daily × 5 days
49387|NCT02283788|O4|Outcome|Placebo|Placebo, PLC
49388|NCT02283788|O3|Outcome|Moxifloxacin 400 mg|brand names Avelox, Avalox, and Avelon
49389|NCT02283788|O2|Outcome|BIA 2-093 2400 mg|ESL, Eslicarbazepine 1200 mg
49390|NCT02283788|O1|Outcome|BIA 2-093 1200 mg|ESL, Eslicarbazepine 1200 mg
49391|NCT02283788|E4|Reported Event|Group D|Period 1 - placebo once daily × 5 days Period 2 - Moxifloxacin 400 mg × 1 dose Period 3 - BIA 2-093 2400 mg once daily × 5 days Period 4 - BIA 2-093 1200 mg once daily × 5 days
49392|NCT02283788|E3|Reported Event|Group C|Period 1 - Moxifloxacin 400 mg × 1 dose Period 2 - BIA 2-093 1200 mg once daily × 5 days Period 3 - placebo once daily × 5 days Period 4 - BIA 2-093 2400 mg once daily × 5 days
49430|NCT02283268|O6|Outcome|Von Willebrand Disease Type 2A|All participants with von Willebrand Disease Type 2A.
49393|NCT02283788|E2|Reported Event|Group B|Period 1 - BIA 2-093 2400 mg once daily × 5 days Period 2 - placebo once daily × 5 days Period 3 - BIA 2-093 1200 mg once daily × 5 days Period 4 - Moxifloxacin 400 mg × 1 dose
49394|NCT02283788|E1|Reported Event|Group A|Period 1 - BIA 2-093 1200 mg once daily × 5 days Period 2 - BIA 2-093 2400 mg once daily × 5 days Period 3 - Moxifloxacin 400 mg × 1 dose Period 4 - placebo once daily × 5 days
49395|NCT02283411|B1|Baseline|Diabetes Mellitus, Type 1 and Type 2|"Subjects will wear the Abbott Sensor Based Glucose Monitoring Systems and will receive no treatment except for safety purposes.~Abbott Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring Systems and will receive no treatment except for safety purposes."
49396|NCT02283411|P1|Participant Flow|Diabetes Mellitus, Type 1 and Type 2|"Subjects will wear the Abbott Sensor Based Glucose Monitoring Systems and will receive no treatment except for safety purposes.~Abbott Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring Systems and will receive no treatment except for safety purposes."
49397|NCT02283411|O1|Outcome|Diabetes Mellitus, Type 1 and Type 2|"Subjects wore the Abbott Sensor Based Glucose Monitoring Systems (Personal[P] and Professional [Pro] and received no treatment except for safety purposes.~Abbott Sensor Based Glucose Monitoring System: Subjects wore the Abbott Sensor Based Glucose Monitoring Systems and received no treatment except for safety purposes."
49398|NCT02283411|O1|Outcome|Diabetes Mellitus, Type 1 and Type 2|"Subjects wore the Abbott Sensor Based Glucose Monitoring Systems (Personal[P] and Professional [Pro] and received no treatment except for safety purposes.~Abbott Sensor Based Glucose Monitoring System: Subjects wore the Abbott Sensor Based Glucose Monitoring Systems and received no treatment except for safety purposes."
49399|NCT02283411|O1|Outcome|Diabetes Mellitus, Type 1 and Type 2|"Subjects wore the Abbott Sensor Based Glucose Monitoring Systems (Personal[P] and Professional [Pro] and received no treatment except for safety purposes.~Abbott Sensor Based Glucose Monitoring System: Subjects wore the Abbott Sensor Based Glucose Monitoring Systems and received no treatment except for safety purposes."
49400|NCT02283411|O1|Outcome|Diabetes Mellitus, Type 1 and Type 2|"Subjects wore the Abbott Sensor Based Glucose Monitoring Systems (Personal[P] and Professional [Pro] and received no treatment except for safety purposes.~Abbott Sensor Based Glucose Monitoring System: Subjects wore the Abbott Sensor Based Glucose Monitoring Systems and received no treatment except for safety purposes."
49401|NCT02283411|O1|Outcome|Diabetes Mellitus, Type 1 and Type 2|"Subjects wore the Abbott Sensor Based Glucose Monitoring Systems (Personal[P] and Professional [Pro] and received no treatment except for safety purposes.~Abbott Sensor Based Glucose Monitoring System: Subjects wore the Abbott Sensor Based Glucose Monitoring Systems and received no treatment except for safety purposes."
49402|NCT02283411|E1|Reported Event|Diabetes Mellitus, Type 1 and Type 2|"Subjects wore the Abbott Sensor Based Glucose Monitoring Systems (Personal[P] and Professional [Pro] and received no treatment except for safety purposes.~Reported adverse events were determined to be related to study procedures. Those events were observed in six (6) subjects who wore the two Systems (Personal[P] and Professional [Pro]) as required by protocol."
49403|NCT02283268|B1|Baseline|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
49404|NCT02283268|P1|Participant Flow|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
49405|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
49406|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
49407|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
49408|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
49409|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
49410|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
49411|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
49412|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
49413|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
49414|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
49415|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
49416|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
49417|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
49418|NCT02283268|O9|Outcome|Von Willebrand Disease Type 3|All participants with von Willebrand Disease Type 3.
49419|NCT02283268|O8|Outcome|Von Willebrand Disease Type 2M|All participants with von Willebrand Disease Type 2M.
49420|NCT02283268|O7|Outcome|Von Willebrand Disease Type 2B|All participants with von Willebrand Disease Type 2B.
49421|NCT02283268|O6|Outcome|Von Willebrand Disease Type 2A|All participants with von Willebrand Disease Type 2A.
49422|NCT02283268|O5|Outcome|Von Willebrand Disease Type 1|All participants with von Willebrand Disease Type 1.
49423|NCT02283268|O4|Outcome|Oral Surgery|All participants who underwent oral surgery.
49424|NCT02283268|O3|Outcome|Major Surgery|All participants who underwent major surgery.
49425|NCT02283268|O2|Outcome|Minor Surgery|All participants who underwent minor surgery.
49426|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
49427|NCT02283268|O9|Outcome|Von Willebrand Disease Type 3|All participants with von Willebrand Disease Type 3.
49428|NCT02283268|O8|Outcome|Von Willebrand Disease Type 2M|All participants with von Willebrand Disease Type 2M.
49429|NCT02283268|O7|Outcome|Von Willebrand Disease Type 2B|All participants with von Willebrand Disease Type 2B.
49431|NCT02283268|O5|Outcome|Von Willebrand Disease Type 1|All participants with von Willebrand Disease Type 1.
49432|NCT02283268|O4|Outcome|Oral Surgery|All participants who underwent oral surgery.
49433|NCT02283268|O3|Outcome|Major Surgery|All participants who underwent major surgery.
49434|NCT02283268|O2|Outcome|Minor Surgery|All participants who underwent minor surgery.
49435|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
49436|NCT02283268|O9|Outcome|Von Willebrand Disease Type 3|All participants with von Willebrand Disease Type 3.
49437|NCT02283268|O8|Outcome|Von Willebrand Disease Type 2M|All participants with von Willebrand Disease Type 2M.
49438|NCT02283268|O7|Outcome|Von Willebrand Disease Type 2B|All participants with von Willebrand Disease Type 2B.
49439|NCT02283268|O6|Outcome|Von Willebrand Disease Type 2A|All participants with von Willebrand Disease Type 2A.
49440|NCT02283268|O5|Outcome|Von Willebrand Disease Type 1|All participants with von Willebrand Disease Type 1.
49441|NCT02283268|O4|Outcome|Oral Surgery|All participants who underwent oral surgery.
49442|NCT02283268|O3|Outcome|Major Surgery|All participants who underwent major surgery.
49443|NCT02283268|O2|Outcome|Minor Surgery|All participants who underwent minor surgery.
49444|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
49445|NCT02283268|O9|Outcome|Von Willebrand Disease Type 3|All participants with von Willebrand Disease Type 3.
49446|NCT02283268|O8|Outcome|Von Willebrand Disease Type 2M|All participants with von Willebrand Disease Type 2M.
49447|NCT02283268|O7|Outcome|Von Willebrand Disease Type 2B|All participants with von Willebrand Disease Type 2B.
49448|NCT02283268|O6|Outcome|Von Willebrand Disease Type 2A|All participants with von Willebrand Disease Type 2A.
49449|NCT02283268|O5|Outcome|Von Willebrand Disease Type 1|All participants with von Willebrand Disease Type 1.
49450|NCT02283268|O4|Outcome|Oral Surgery|All participants who underwent oral surgery.
49451|NCT02283268|O3|Outcome|Major Surgery|All participants who underwent major surgery.
49452|NCT02283268|O2|Outcome|Minor Surgery|All participants who underwent minor surgery.
49453|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
49454|NCT02283268|O9|Outcome|Von Willebrand Disease Type 3|All participants with von Willebrand Disease Type 3.
49455|NCT02283268|O8|Outcome|Von Willebrand Disease Type 2M|All participants with von Willebrand Disease Type 2M.
49456|NCT02283268|O7|Outcome|Von Willebrand Disease Type 2B|All participants with von Willebrand Disease Type 2B.
49457|NCT02283268|O6|Outcome|Von Willebrand Disease Type 2A|All participants with von Willebrand Disease Type 2A.
49458|NCT02283268|O5|Outcome|Von Willebrand Disease Type 1|All participants with von Willebrand Disease Type 1.
49459|NCT02283268|O4|Outcome|Oral Surgery|All participants who underwent oral surgery.
49460|NCT02283268|O3|Outcome|Major Surgery|All participants who underwent major surgery.
49461|NCT02283268|O2|Outcome|Minor Surgery|All participants who underwent minor surgery.
49462|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
49463|NCT02283268|E1|Reported Event|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
49464|NCT02282982|B1|Baseline|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
49465|NCT02282982|P1|Participant Flow|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
49466|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
49467|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
49468|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
49469|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
49470|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
49471|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
49472|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
49473|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
49474|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
49475|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
49476|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
49477|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
49478|NCT02282982|E1|Reported Event|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
49479|NCT02282813|B4|Baseline|Total|Total of all reporting groups
49480|NCT02282813|B3|Baseline|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
49481|NCT02282813|B2|Baseline|CTAP101 Capsules (Monotherapy; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
49482|NCT02282813|B1|Baseline|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
49483|NCT02282813|P3|Participant Flow|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
49484|NCT02282813|P2|Participant Flow|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
49485|NCT02282813|P1|Participant Flow|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
49486|NCT02282813|O3|Outcome|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
49487|NCT02282813|O2|Outcome|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
49488|NCT02282813|O1|Outcome|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
49489|NCT02282813|O3|Outcome|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
49490|NCT02282813|O2|Outcome|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
49491|NCT02282813|O1|Outcome|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
49492|NCT02282813|O3|Outcome|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
49493|NCT02282813|O2|Outcome|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
49494|NCT02282813|O1|Outcome|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
49495|NCT02282813|O3|Outcome|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
49496|NCT02282813|O2|Outcome|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects continued to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
49497|NCT02282813|O1|Outcome|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects continued to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
49498|NCT02282813|E3|Reported Event|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
49499|NCT02282813|E2|Reported Event|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
49500|NCT02282813|E1|Reported Event|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
49501|NCT02282722|B3|Baseline|Total|Total of all reporting groups
49502|NCT02282722|B2|Baseline|Investigational Informed Consent|"Study participant will receive investigational informed consent for chemotherapy materials that were developed by the study team.~Investigational informed consent for chemotherapy: Investigational informed consent materials consist of regimen-specific multimedia tools: a video plus a booklet."
49503|NCT02282722|B1|Baseline|Usual Informed Consent|"Study participant will receive usual, standard-of-care informed consent for chemotherapy materials.~Usual, standard-of-care informed consent for chemotherapy: The enrolling site's institutional standard-of-care informed consent materials."
49504|NCT02282722|P2|Participant Flow|Patient Investigational Care Arm|Patients randomized to the investigational informed consent materials.
49505|NCT02282722|P1|Participant Flow|Patient Usual Care Arm|Patients randomized to usual care informed consent materials.
49506|NCT02282722|O2|Outcome|Patient Investigational Care Arm|Patients randomized to the investigational informed consent materials.
49507|NCT02282722|O1|Outcome|Patient Usual Care Arm|Patients randomized to usual care informed consent materials.
49508|NCT02282722|O2|Outcome|Patient Investigational Care Arm|Patients randomized to the investigational informed consent materials.
49509|NCT02282722|O1|Outcome|Patient Usual Care Arm|Patients randomized to usual care informed consent materials.
68292|NCT02151461|O2|Outcome|FDC250|Leucine 1100mg +Metformin 250mg
49510|NCT02282722|O2|Outcome|Patient Investigational Care Arm|Patients randomized to the investigational informed consent materials.
49511|NCT02282722|O1|Outcome|Patient Usual Care Arm|Patients randomized to usual care informed consent materials.
49512|NCT02282722|O2|Outcome|Patient Investigational Care Arm|Patients randomized to the investigational informed consent materials.
49513|NCT02282722|O1|Outcome|Patient Usual Care Arm|Patients randomized to usual care informed consent materials.
49514|NCT02282722|O2|Outcome|Patient Investigational Care Arm|Patients randomized to the investigational informed consent materials.
49515|NCT02282722|O1|Outcome|Patient Usual Care Arm|Patients randomized to usual care informed consent materials.
49516|NCT02282722|O2|Outcome|Patient Investigational Care Arm|Patients randomized to the investigational informed consent materials.
49517|NCT02282722|O1|Outcome|Patient Usual Care Arm|Patients randomized to usual care informed consent materials.
49518|NCT02282722|O2|Outcome|Patient Investigational Care Arm|Patients randomized to the investigational informed consent materials.
49519|NCT02282722|O1|Outcome|Patient Usual Care Arm|Patients randomized to usual care informed consent materials.
49520|NCT02282722|O2|Outcome|Patient Investigational Care Arm|Patients randomized to the investigational informed consent materials.
49521|NCT02282722|O1|Outcome|Patient Usual Care Arm|Patients randomized to usual care informed consent materials.
49522|NCT02282722|O2|Outcome|Patient Investigational Care Arm|Patients randomized to the investigational informed consent materials.
49523|NCT02282722|O1|Outcome|Patient Usual Care Arm|Patients randomized to usual care informed consent materials.
49524|NCT02282722|O2|Outcome|Patient Investigational Care Arm|Patients randomized to the investigational informed consent materials.
49525|NCT02282722|O1|Outcome|Patient Usual Care Arm|Patients randomized to usual care informed consent materials.
49526|NCT02282722|E2|Reported Event|Patient Investigational Care Arm|Patients randomized to the investigational informed consent materials.
49527|NCT02282722|E1|Reported Event|Patient Usual Care Arm|Patients randomized to usual care informed consent materials.
49528|NCT02282631|B3|Baseline|Total|Total of all reporting groups
49529|NCT02282631|B2|Baseline|Intervention School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw. Every trip to school reported by the parent as being active (walking/cycling) corresponds to one ticket entered into the draw. In total, one child can have up to five tickets entered into one draw."
49530|NCT02282631|B1|Baseline|Control School|School with no intervention; ongoing advice on active school travel.
49531|NCT02282631|P2|Participant Flow|Intervention Group School|School with intervention (incentive scheme)
49532|NCT02282631|P1|Participant Flow|Control Group School|School with no intervention (incentive scheme)
49533|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
49534|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
49535|NCT02282631|O2|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
49536|NCT02282631|O1|Outcome|Intervention Group School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
49537|NCT02282631|O2|Outcome|Non-ATS Trips|non-active trips to school (e.g. car trips)
49538|NCT02282631|O1|Outcome|ATS Trips|active trips to school
49539|NCT02282631|O2|Outcome|Non-ATS Trips|non-active trips to school (e.g. car trips)
49540|NCT02282631|O1|Outcome|ATS Trips|active trips to school
49541|NCT02282631|O2|Outcome|Non-ATS Trips|non-active trips to school (e.g. car trips)
49542|NCT02282631|O1|Outcome|ATS Trips|active trips to school
49543|NCT02282631|O2|Outcome|Non-ATS Trips|non-active trips to school (e.g. car trips)
49544|NCT02282631|O1|Outcome|ATS Trips|active trips to school
49545|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
49546|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
49547|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
49548|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
49549|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
49550|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
49551|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
49552|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
49553|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
49554|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
49763|NCT02281357|O1|Outcome|Tralokinumab|Tralokinumab 300 mg administered by SC injection Q2W over a 40-week treatment period.
49555|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
49556|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
49557|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
49558|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
49559|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
49560|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
49561|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
49562|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
49563|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
49564|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
49565|NCT02282631|O1|Outcome|Schools Who Took Part|Schools who took part in this study (two)
49566|NCT02282631|O1|Outcome|Schools Contacted|Primary schools (or equivalent) located in the North East approached in this study
49567|NCT02282631|E2|Reported Event|Intervention Group School|School with intervention (incentive scheme)
49568|NCT02282631|E1|Reported Event|Control Group School|School with no intervention (incentive scheme)
49569|NCT02282605|B4|Baseline|Total|Total of all reporting groups
49570|NCT02282605|B3|Baseline|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
49571|NCT02282605|B2|Baseline|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
49572|NCT02282605|B1|Baseline|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
49573|NCT02282605|P3|Participant Flow|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
49574|NCT02282605|P2|Participant Flow|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
49575|NCT02282605|P1|Participant Flow|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
49576|NCT02282605|O3|Outcome|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
49577|NCT02282605|O2|Outcome|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
49578|NCT02282605|O1|Outcome|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
49579|NCT02282605|O3|Outcome|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
49580|NCT02282605|O2|Outcome|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
49581|NCT02282605|O1|Outcome|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
49764|NCT02281357|O2|Outcome|Placebo|Placebo was administered by SC injection over a 40-week treatment period.
68293|NCT02151461|O1|Outcome|FDC125|Leucine 1100mg +Metformin 125mg
49582|NCT02282605|O3|Outcome|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
49583|NCT02282605|O2|Outcome|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
49584|NCT02282605|O1|Outcome|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
49585|NCT02282605|O3|Outcome|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
49586|NCT02282605|O2|Outcome|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
49587|NCT02282605|O1|Outcome|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
49588|NCT02282605|O3|Outcome|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
49589|NCT02282605|O2|Outcome|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
49590|NCT02282605|O1|Outcome|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
49591|NCT02282605|E3|Reported Event|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
49592|NCT02282605|E2|Reported Event|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
49593|NCT02282605|E1|Reported Event|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
49594|NCT02282527|B3|Baseline|Total|Total of all reporting groups
49595|NCT02282527|B2|Baseline|Prolastin-C/Liquid Alpha₁-PI|"Subjects were treated first with Prolastin-C and then treated with Liquid Alpha₁-PI~Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions~Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions"
49596|NCT02282527|B1|Baseline|Liquid Alpha₁-PI/Prolastin-C|"Subjects were treated first with Liquid Alpha₁-PI and then treated with Prolastin-C~Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions~Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions"
49597|NCT02282527|P2|Participant Flow|Prolastin-C/Liquid Alpha₁-PI|"Subjects were treated first with Prolastin-C and then treated with Liquid Alpha₁-PI~Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions~Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions"
49598|NCT02282527|P1|Participant Flow|Liquid Alpha₁-PI/Prolastin-C|"Subjects were treated first with Liquid Alpha₁-PI and then treated with Prolastin-C~Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions~Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions"
49599|NCT02282527|O2|Outcome|Prolastin-C/Liquid Alpha₁-PI|"Subjects were treated first with Prolastin-C and then treated with Liquid Alpha₁-PI~Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions~Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions"
49600|NCT02282527|O1|Outcome|Liquid Alpha₁-PI/Prolastin-C|"Subjects were treated first with Liquid Alpha₁-PI and then treated with Prolastin-C~Liquid Alpha₁-PI: Liquid Alpha1-PI, 60 mg/kg, 8 weekly intravenous infusions~Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions"
49601|NCT02282527|O2|Outcome|Prolastin-C|"Subjects treated with Prolastin-C in each treatment sequence~Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions"
49602|NCT02282527|O1|Outcome|Liquid Alpha₁-PI|"Subjects treated with Liquid Alpha₁-PI in each treatment sequence~Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions"
49603|NCT02282527|O2|Outcome|Prolastin-C|"Subjects treated with Prolastin-C in each treatment sequence~Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions"
49604|NCT02282527|O1|Outcome|Liquid Alpha₁-PI|"Subjects treated with Liquid Alpha₁-PI in each treatment sequence~Liquid Alpha₁-PI: Liquid Alpha1-PI, 60 mg/kg, 8 weekly intravenous infusions"
49605|NCT02282527|E2|Reported Event|Prolastin-C|Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions
49606|NCT02282527|E1|Reported Event|Liquid Alpha₁-PI|Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions
49607|NCT02281773|B6|Baseline|Total|Total of all reporting groups
49608|NCT02281773|B5|Baseline|Placebo|Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
49609|NCT02281773|B4|Baseline|BI 409306 - 100 Milligram|Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
49610|NCT02281773|B3|Baseline|BI 409306 - 50 Milligram|Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
49611|NCT02281773|B2|Baseline|BI 409306 - 25 Milligram|Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
49612|NCT02281773|B1|Baseline|BI 409306 - 10 Milligram|Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
49613|NCT02281773|P5|Participant Flow|Placebo|Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
49614|NCT02281773|P4|Participant Flow|BI 409306 - 100 Milligram|Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
49615|NCT02281773|P3|Participant Flow|BI 409306 - 50 Milligram|Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
49616|NCT02281773|P2|Participant Flow|BI 409306 - 25 Milligram|Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
49617|NCT02281773|P1|Participant Flow|BI 409306 - 10 Milligram|Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
49618|NCT02281773|O5|Outcome|Placebo|Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
49619|NCT02281773|O4|Outcome|BI 409306 - 100 Milligram|Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
49620|NCT02281773|O3|Outcome|BI 409306 - 50 Milligram|Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
49621|NCT02281773|O2|Outcome|BI 409306 - 25 Milligram|Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
49622|NCT02281773|O1|Outcome|BI 409306 - 10 Milligram|Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
49623|NCT02281773|O5|Outcome|Placebo|Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
49624|NCT02281773|O4|Outcome|BI 409306 - 100 Milligram|Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
49625|NCT02281773|O3|Outcome|BI 409306 - 50 Milligram|Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
49626|NCT02281773|O2|Outcome|BI 409306 - 25 Milligram|Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
49627|NCT02281773|O1|Outcome|BI 409306 - 10 Milligram|Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
49628|NCT02281773|O5|Outcome|Placebo|Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
49629|NCT02281773|O4|Outcome|BI 409306 - 100 Milligram|Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
49630|NCT02281773|O3|Outcome|BI 409306 - 50 Milligram|Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
49631|NCT02281773|O2|Outcome|BI 409306 - 25 Milligram|Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
49632|NCT02281773|O1|Outcome|BI 409306 - 10 Milligram|Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
49633|NCT02281773|O5|Outcome|Placebo|Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
49634|NCT02281773|O4|Outcome|BI 409306 - 100 Milligram|Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
49635|NCT02281773|O3|Outcome|BI 409306 - 50 Milligram|Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
49636|NCT02281773|O2|Outcome|BI 409306 - 25 Milligram|Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
49637|NCT02281773|O1|Outcome|BI 409306 - 10 Milligram|Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
49638|NCT02281773|O5|Outcome|Placebo|Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
49639|NCT02281773|O4|Outcome|BI 409306 - 100 Milligram|Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
49765|NCT02281357|O1|Outcome|Tralokinumab|Tralokinumab 300 mg administered by SC injection Q2W over a 40-week treatment period.
49640|NCT02281773|O3|Outcome|BI 409306 - 50 Milligram|Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
49641|NCT02281773|O2|Outcome|BI 409306 - 25 Milligram|Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
49642|NCT02281773|O1|Outcome|BI 409306 - 10 Milligram|Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
49643|NCT02281773|O5|Outcome|Placebo|Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
49644|NCT02281773|O4|Outcome|BI 409306 - 100 Milligram|Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
49645|NCT02281773|O3|Outcome|BI 409306 - 50 Milligram|Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
49646|NCT02281773|O2|Outcome|BI 409306 - 25 Milligram|Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
49647|NCT02281773|O1|Outcome|BI 409306 - 10 Milligram|Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
49648|NCT02281773|O5|Outcome|Placebo|Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
49649|NCT02281773|O4|Outcome|BI 409306 - 100 Milligram|Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
49650|NCT02281773|O3|Outcome|BI 409306 - 50 Milligram|Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
49651|NCT02281773|O2|Outcome|BI 409306 - 25 Milligram|Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
49652|NCT02281773|O1|Outcome|BI 409306 - 10 Milligram|Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
49653|NCT02281773|O5|Outcome|Placebo|Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
49654|NCT02281773|O4|Outcome|BI 409306 - 100 Milligram|Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
49655|NCT02281773|O3|Outcome|BI 409306 - 50 Milligram|Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
49656|NCT02281773|O2|Outcome|BI 409306 - 25 Milligram|Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
49657|NCT02281773|O1|Outcome|BI 409306 - 10 Milligram|Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
49658|NCT02281773|O5|Outcome|Placebo|Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
49659|NCT02281773|O4|Outcome|BI 409306 - 100 Milligram|Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
49660|NCT02281773|O3|Outcome|BI 409306 - 50 Milligram|Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
49661|NCT02281773|O2|Outcome|BI 409306 - 25 Milligram|Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
49662|NCT02281773|O1|Outcome|BI 409306 - 10 Milligram|Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
49663|NCT02281773|O5|Outcome|Placebo|Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
49664|NCT02281773|O4|Outcome|BI 409306 - 100 Milligram|Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
49665|NCT02281773|O3|Outcome|BI 409306 - 50 Milligram|Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
49666|NCT02281773|O2|Outcome|BI 409306 - 25 Milligram|Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
49667|NCT02281773|O1|Outcome|BI 409306 - 10 Milligram|Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
49668|NCT02281773|E5|Reported Event|Placebo|Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
49669|NCT02281773|E4|Reported Event|BI 409306 - 100 Milligram|Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
49670|NCT02281773|E3|Reported Event|BI 409306 - 50 Milligram|Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
49671|NCT02281773|E2|Reported Event|BI 409306 - 25 Milligram|Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
49766|NCT02281357|O2|Outcome|Placebo|Placebo was administered by SC injection over a 40-week treatment period.
49672|NCT02281773|E1|Reported Event|BI 409306 - 10 Milligram|Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
49673|NCT02281591|B5|Baseline|Total|Total of all reporting groups
49674|NCT02281591|B4|Baseline|R-licarbazepine|"450 mg of Rlicarbazepine~R-licarbazepine: capsules containing 225 mg"
49675|NCT02281591|B3|Baseline|S-licarbazepine|"450 mg of S-licarbazepine~S-licarbazepine: capsules containing 225 mg"
49676|NCT02281591|B2|Baseline|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine~S-licarbazepine: capsules containing 225 mg~R-licarbazepine: capsules containing 225 mg"
49677|NCT02281591|B1|Baseline|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)~BIA 2-093: Tablets containing 900 mg"
49678|NCT02281591|P4|Participant Flow|R-licarbazepine|"450 mg of Rlicarbazepine~R-licarbazepine: capsules containing 225 mg"
49679|NCT02281591|P3|Participant Flow|S-licarbazepine|"450 mg of S-licarbazepine~S-licarbazepine: capsules containing 225 mg"
49680|NCT02281591|P2|Participant Flow|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine~S-licarbazepine: capsules containing 225 mg~R-licarbazepine: capsules containing 225 mg"
49681|NCT02281591|P1|Participant Flow|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)~BIA 2-093: Tablets containing 900 mg"
49682|NCT02281591|O4|Outcome|R-licarbazepine|"450 mg of Rlicarbazepine~R-licarbazepine: capsules containing 225 mg"
49683|NCT02281591|O3|Outcome|S-licarbazepine|"450 mg of S-licarbazepine~S-licarbazepine: capsules containing 225 mg"
49684|NCT02281591|O2|Outcome|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine~S-licarbazepine: capsules containing 225 mg~R-licarbazepine: capsules containing 225 mg"
49685|NCT02281591|O1|Outcome|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)~BIA 2-093: Tablets containing 900 mg"
49686|NCT02281591|O4|Outcome|R-licarbazepine|"450 mg of Rlicarbazepine~R-licarbazepine: capsules containing 225 mg"
49687|NCT02281591|O3|Outcome|S-licarbazepine|"450 mg of S-licarbazepine~S-licarbazepine: capsules containing 225 mg"
49688|NCT02281591|O2|Outcome|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine~S-licarbazepine: capsules containing 225 mg~R-licarbazepine: capsules containing 225 mg"
49689|NCT02281591|O1|Outcome|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)~BIA 2-093: Tablets containing 900 mg"
49690|NCT02281591|O4|Outcome|R-licarbazepine|"450 mg of Rlicarbazepine~R-licarbazepine: capsules containing 225 mg"
49691|NCT02281591|O3|Outcome|S-licarbazepine|"450 mg of S-licarbazepine~S-licarbazepine: capsules containing 225 mg"
49692|NCT02281591|O2|Outcome|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine~S-licarbazepine: capsules containing 225 mg~R-licarbazepine: capsules containing 225 mg"
49693|NCT02281591|O1|Outcome|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)~BIA 2-093: Tablets containing 900 mg"
49694|NCT02281591|O4|Outcome|R-licarbazepine|"450 mg of Rlicarbazepine~R-licarbazepine: capsules containing 225 mg"
49695|NCT02281591|O3|Outcome|S-licarbazepine|"450 mg of S-licarbazepine~S-licarbazepine: capsules containing 225 mg"
49696|NCT02281591|O2|Outcome|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine~S-licarbazepine: capsules containing 225 mg~R-licarbazepine: capsules containing 225 mg"
49697|NCT02281591|O1|Outcome|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)~BIA 2-093: Tablets containing 900 mg"
49698|NCT02281591|E4|Reported Event|R-licarbazepine|"450 mg of Rlicarbazepine~R-licarbazepine: capsules containing 225 mg"
49699|NCT02281591|E3|Reported Event|S-licarbazepine|"450 mg of S-licarbazepine~S-licarbazepine: capsules containing 225 mg"
49700|NCT02281591|E2|Reported Event|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine~S-licarbazepine: capsules containing 225 mg~R-licarbazepine: capsules containing 225 mg"
49701|NCT02281591|E1|Reported Event|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)~BIA 2-093: Tablets containing 900 mg"
49702|NCT02281526|B3|Baseline|Total|Total of all reporting groups
49703|NCT02281526|B2|Baseline|Subjects - Healthy Controls|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
49704|NCT02281526|B1|Baseline|Subjects With Moderate Hepatic Impairment|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
49705|NCT02281526|P2|Participant Flow|Subjects - Healthy Controls|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
49706|NCT02281526|P1|Participant Flow|Subjects With Moderate Hepatic Impairment|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
49707|NCT02281526|O2|Outcome|Subjects - Healthy Controls|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
49708|NCT02281526|O1|Outcome|Subjects With Moderate Hepatic Impairment|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
49709|NCT02281526|O2|Outcome|Subjects - Healthy Controls|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
49710|NCT02281526|O1|Outcome|Subjects With Moderate Hepatic Impairment|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
49711|NCT02281526|E2|Reported Event|Subjects - Healthy Controls|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
49712|NCT02281526|E1|Reported Event|Subjects With Moderate Hepatic Impairment|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
49713|NCT02281448|B3|Baseline|Total|Total of all reporting groups
49988|NCT02279641|O4|Outcome|Oxypurinol: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
49714|NCT02281448|B2|Baseline|Treatment Sequence B|"oral single-dose of a contraceptive for 3 days after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days~BIA 2-093~Contraceptives, Oral, Combined"
49715|NCT02281448|B1|Baseline|Treatment Sequence A|"oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days followed by washout and 3 days of oral single-dose contraceptive~BIA 2-093~Contraceptives, Oral, Combined"
49716|NCT02281448|P2|Participant Flow|Treatment Sequence B|"oral single-dose of a contraceptive for 3 days after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days~BIA 2-093~Contraceptives, Oral, Combined"
49717|NCT02281448|P1|Participant Flow|Treatment Sequence A|"oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days followed by washout and 3 days of oral single-dose contraceptive~BIA 2-093~Contraceptives, Oral, Combined"
49718|NCT02281448|O1|Outcome|Overall Population|Overall population - 17 subjects
49719|NCT02281448|O1|Outcome|Overall Population|Overall population - 17 subjects
49720|NCT02281448|O1|Outcome|Overall Population|Overall population - 17 subjects
49721|NCT02281448|O1|Outcome|Cmax (BIA 2-194)|Mean trough (pre-dose) plasma concentrations of BIA 2-194 on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.
49722|NCT02281448|E2|Reported Event|Microginon®|Microginon® (n=18)
49723|NCT02281448|E1|Reported Event|Eslicarbazepine Acetate 1200 mg + Microginon®|Eslicarbazepine acetate 1200 mg + Microginon® (n=19)
49724|NCT02281422|B6|Baseline|Total|Total of all reporting groups
49725|NCT02281422|B5|Baseline|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)~BIA 2-093"
49726|NCT02281422|B4|Baseline|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)~BIA 2-093"
49727|NCT02281422|B3|Baseline|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)~BIA 2-093"
49728|NCT02281422|B2|Baseline|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)~BIA 2-093"
49729|NCT02281422|B1|Baseline|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)~BIA 2-093"
49730|NCT02281422|P5|Participant Flow|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)~BIA 2-093"
49731|NCT02281422|P4|Participant Flow|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)~BIA 2-093"
49732|NCT02281422|P3|Participant Flow|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)~BIA 2-093"
49733|NCT02281422|P2|Participant Flow|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)~BIA 2-093"
49734|NCT02281422|P1|Participant Flow|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)~BIA 2-093"
49735|NCT02281422|O5|Outcome|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)~BIA 2-093"
49736|NCT02281422|O4|Outcome|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)~BIA 2-093"
49737|NCT02281422|O3|Outcome|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)~BIA 2-093"
49738|NCT02281422|O2|Outcome|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)~BIA 2-093"
49739|NCT02281422|O1|Outcome|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)~BIA 2-093"
49740|NCT02281422|O5|Outcome|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)~BIA 2-093"
49741|NCT02281422|O4|Outcome|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)~BIA 2-093"
49742|NCT02281422|O3|Outcome|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)~BIA 2-093"
49743|NCT02281422|O2|Outcome|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)~BIA 2-093"
49744|NCT02281422|O1|Outcome|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)~BIA 2-093"
49745|NCT02281422|O5|Outcome|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)~BIA 2-093"
49746|NCT02281422|O4|Outcome|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)~BIA 2-093"
49747|NCT02281422|O3|Outcome|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)~BIA 2-093"
49748|NCT02281422|O2|Outcome|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)~BIA 2-093"
49749|NCT02281422|O1|Outcome|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)~BIA 2-093"
49750|NCT02281422|E5|Reported Event|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)~BIA 2-093"
49751|NCT02281422|E4|Reported Event|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)~BIA 2-093"
49752|NCT02281422|E3|Reported Event|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)~BIA 2-093"
49753|NCT02281422|E2|Reported Event|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)~BIA 2-093"
49754|NCT02281422|E1|Reported Event|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)~BIA 2-093"
49755|NCT02281357|B3|Baseline|Total|Total of all reporting groups
49756|NCT02281357|B2|Baseline|Placebo|Placebo was administered by SC injection over a 40-week treatment period.
49757|NCT02281357|B1|Baseline|Tralokinumab|Tralokinumab 300 mg administered by SC injection Q2W over a 40-week treatment period.
49758|NCT02281357|P2|Participant Flow|Placebo|Placebo was administered by SC injection over a 40-week treatment period.
49759|NCT02281357|P1|Participant Flow|Tralokinumab|Tralokinumab 300 milligrams (mg) administered by subcutaneous (SC) injection every two weeks (Q2W) over a 40-week treatment period.
49760|NCT02281357|O2|Outcome|Placebo|Placebo was administered by SC injection over a 40-week treatment period.
49761|NCT02281357|O1|Outcome|Tralokinumab|Tralokinumab 300 mg administered by SC injection Q2W over a 40-week treatment period.
49762|NCT02281357|O2|Outcome|Placebo|Placebo was administered by SC injection over a 40-week treatment period.
49767|NCT02281357|O1|Outcome|Tralokinumab|Tralokinumab 300 mg administered by SC injection Q2W over a 40-week treatment period.
49768|NCT02281357|E2|Reported Event|Placebo|Placebo was administered by SC injection over a 40-week treatment period.
49769|NCT02281357|E1|Reported Event|Tralo 300 mg Q2W|Tralokinumab 300 mg administered by SC injection Q2W over a 40-week treatment period.
49770|NCT02281318|B3|Baseline|Total|Total of all reporting groups
49771|NCT02281318|B2|Baseline|Mepolizumab 100 mg|Participants received mepolizumab 100 mg subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
49772|NCT02281318|B1|Baseline|Placebo|Participants received placebo subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
49773|NCT02281318|P2|Participant Flow|Mepolizumab 100 mg|Participants received mepolizumab 100 mg subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
49774|NCT02281318|P1|Participant Flow|Placebo|Participants received placebo subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
49775|NCT02281318|O2|Outcome|Mepolizumab 100 mg|Participants received mepolizumab 100 mg subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
49776|NCT02281318|O1|Outcome|Placebo|Participants received placebo subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
49777|NCT02281318|O2|Outcome|Mepolizumab 100 mg|Participants received mepolizumab 100 mg subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
49778|NCT02281318|O1|Outcome|Placebo|Participants received placebo subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
49779|NCT02281318|O2|Outcome|Mepolizumab 100 mg|Participants received mepolizumab 100 mg subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
49780|NCT02281318|O1|Outcome|Placebo|Participants received placebo subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
49781|NCT02281318|O2|Outcome|Mepolizumab 100 mg|Participants received mepolizumab 100 mg subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
49782|NCT02281318|O1|Outcome|Placebo|Participants received placebo subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
49783|NCT02281318|E2|Reported Event|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
49784|NCT02281318|E1|Reported Event|Placebo|Participants received placebo subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
49785|NCT02281136|B1|Baseline|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49786|NCT02281136|P1|Participant Flow|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49787|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49788|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49789|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49790|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49791|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49898|NCT02280473|E1|Reported Event|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
49792|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49793|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49794|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49795|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49796|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49797|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49798|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49799|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49800|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49801|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49802|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49803|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49804|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49805|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49806|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49807|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49808|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49809|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49810|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49899|NCT02280226|B1|Baseline|Deliberate Apnea Group|"Subjects undergo maximum apnea.~magnetic resonance imaging (MRI)"
49811|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49812|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49813|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49814|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49815|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49816|NCT02281136|E1|Reported Event|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
49817|NCT02280811|B6|Baseline|Total|Total of all reporting groups
49818|NCT02280811|B5|Baseline|HPV-16 E6 mTCR PBL MTD + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49819|NCT02280811|B4|Baseline|HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49820|NCT02280811|B3|Baseline|HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49821|NCT02280811|B2|Baseline|HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49822|NCT02280811|B1|Baseline|HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49823|NCT02280811|P5|Participant Flow|HPV-16 E6 mTCR PBL MTD + HD IL-2|"This is the phase 2 arm that was treated at the MTD determined in the phase 1 portion.~patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49824|NCT02280811|P4|Participant Flow|HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49825|NCT02280811|P3|Participant Flow|HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49826|NCT02280811|P2|Participant Flow|HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49827|NCT02280811|P1|Participant Flow|HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49828|NCT02280811|O5|Outcome|HPV-16 E6 mTCR PBL MTD + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49829|NCT02280811|O4|Outcome|HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49830|NCT02280811|O3|Outcome|HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49831|NCT02280811|O2|Outcome|HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49832|NCT02280811|O1|Outcome|HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49833|NCT02280811|O5|Outcome|HPV-16 E6 mTCR PBL MTD + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49834|NCT02280811|O4|Outcome|HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49900|NCT02280226|P1|Participant Flow|Deliberate Apnea Group|
49901|NCT02280226|O1|Outcome|Deliberate Apnea Group|"Subjects undergo maximum apnea.~magnetic resonance imaging (MRI)"
49902|NCT02280226|O1|Outcome|Deliberate Apnea Group|"Subjects undergo maximum apnea.~magnetic resonance imaging (MRI)"
49835|NCT02280811|O3|Outcome|HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49836|NCT02280811|O2|Outcome|HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49837|NCT02280811|O1|Outcome|HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49838|NCT02280811|O5|Outcome|HPV-16 E6 mTCR PBL MTD + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49839|NCT02280811|O4|Outcome|HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49840|NCT02280811|O3|Outcome|HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49841|NCT02280811|O2|Outcome|HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49842|NCT02280811|O1|Outcome|HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49843|NCT02280811|O5|Outcome|HPV-16 E6 mTCR PBL MTD + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49844|NCT02280811|O4|Outcome|HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49903|NCT02280226|E1|Reported Event|Deliberate Apnea Group|Subjects undergo maximum apnea and magnetic resonance imaging (MRI) was performed.
49989|NCT02279641|O3|Outcome|Oxypurinol: Allopurinol Alone|Allopurinol 300 mg qd
49990|NCT02279641|O2|Outcome|Allopurinol: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
49845|NCT02280811|O3|Outcome|HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49846|NCT02280811|O2|Outcome|HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49847|NCT02280811|O1|Outcome|HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49848|NCT02280811|O5|Outcome|HPV-16 E6 mTCR PBL MTD + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49849|NCT02280811|O4|Outcome|HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49850|NCT02280811|O3|Outcome|HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49851|NCT02280811|O2|Outcome|HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49852|NCT02280811|O1|Outcome|HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49853|NCT02280811|O5|Outcome|HPV-16 E6 mTCR PBL MTD + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49854|NCT02280811|O4|Outcome|HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49904|NCT02280187|B1|Baseline|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
49855|NCT02280811|O3|Outcome|HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49856|NCT02280811|O2|Outcome|HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49857|NCT02280811|O1|Outcome|HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49858|NCT02280811|O1|Outcome|All Treated Subjects|All treated subjects who received at least one dose of human papilloma virus (HPV)-16 E6 monoclonal T cell receptor (mTCR) peripheral blood lymphocytes (PBL) 1x10^9, 1x10^10,1x10^11, >1x10^11 up to 2x10^11 + high-dose (HD) interleukin 2 (IL-2) were included.
49859|NCT02280811|E6|Reported Event|HPV-16 E6 mTCR PBL MTD + HD IL-2-Retreatment|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49860|NCT02280811|E5|Reported Event|HPV-16 E6 mTCR PBL MTD + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49861|NCT02280811|E4|Reported Event|HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49862|NCT02280811|E3|Reported Event|HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49863|NCT02280811|E2|Reported Event|HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49864|NCT02280811|E1|Reported Event|HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
49865|NCT02280655|B3|Baseline|Total|Total of all reporting groups
49866|NCT02280655|B2|Baseline|Fresh Red Blood Cells (RBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days.~Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)"
49984|NCT02279641|O4|Outcome|Oxypurinol: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
49985|NCT02279641|O3|Outcome|Oxypurinol: Allopurinol Alone|Allopurinol 300 mg qd
49867|NCT02280655|B1|Baseline|Storage-aged Red Blood Cells (saRBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days.~Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)"
49868|NCT02280655|P2|Participant Flow|Fresh Red Blood Cells (RBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days.~Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)"
49869|NCT02280655|P1|Participant Flow|Storage-aged Red Blood Cells (saRBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days.~Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)"
49870|NCT02280655|O2|Outcome|Fresh Red Blood Cells (RBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days.~Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)"
49871|NCT02280655|O1|Outcome|Storage-aged Red Blood Cells (saRBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days.~Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)"
49872|NCT02280655|O2|Outcome|Fresh Red Blood Cells (RBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days.~Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)"
49873|NCT02280655|O1|Outcome|Storage-aged Red Blood Cells (saRBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days.~Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)"
49874|NCT02280655|E2|Reported Event|Fresh Red Blood Cells (RBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days.~Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)"
49875|NCT02280655|E1|Reported Event|Storage-aged Red Blood Cells (saRBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days.~Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)"
49876|NCT02280499|B1|Baseline|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
49877|NCT02280499|P1|Participant Flow|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
49878|NCT02280499|O1|Outcome|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
49879|NCT02280499|O1|Outcome|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
49880|NCT02280499|O1|Outcome|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
49881|NCT02280499|E1|Reported Event|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
49882|NCT02280473|B3|Baseline|Total|Total of all reporting groups
49883|NCT02280473|B2|Baseline|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
49884|NCT02280473|B1|Baseline|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
49885|NCT02280473|P2|Participant Flow|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
49886|NCT02280473|P1|Participant Flow|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
49887|NCT02280473|O2|Outcome|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
49888|NCT02280473|O1|Outcome|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
49889|NCT02280473|O2|Outcome|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
49890|NCT02280473|O1|Outcome|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
49891|NCT02280473|O2|Outcome|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
49892|NCT02280473|O1|Outcome|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
49893|NCT02280473|O2|Outcome|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
49894|NCT02280473|O1|Outcome|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
49895|NCT02280473|O2|Outcome|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
49896|NCT02280473|O1|Outcome|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
49897|NCT02280473|E2|Reported Event|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
49991|NCT02279641|O1|Outcome|Allopurinol: Allopurinol Alone|Allopurinol 300 mg qd
49905|NCT02280187|P1|Participant Flow|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
49906|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
49907|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
49908|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
49909|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
49910|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
49911|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
49912|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
49913|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
49914|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
49915|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
49916|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
49917|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
49918|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
49919|NCT02280187|E1|Reported Event|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
49920|NCT02280122|B3|Baseline|Total|Total of all reporting groups
49921|NCT02280122|B2|Baseline|Periodontally Healthy|"PPD ≤ 3 mm~PAL-V ≤ 2 mm at < 30% of sites~BOP < 20%~No radiographically detectable bone loss: distance cemento-enamel junction to provided~no Intervention but aMMP-8 test~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
49922|NCT02280122|B1|Baseline|Generalised Moderate to Severe Chronic Periodontitis|"Sites with probing pocket depths (PPD) ≥ 3.5 mm~Attachment loss (PAL-V) ≥ 3 mm > 30% of sites~no Intervention provided~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
49923|NCT02280122|P3|Participant Flow|Periodontally Healthy|"PPD ≤ 3 mm~PAL-V ≤ 2 mm at < 30% of sites~BOP < 20%~No radiographically detectable bone loss: distance cemento-enamel junction to provided~no Intervention but aMMP-8 test~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
49924|NCT02280122|P2|Participant Flow|Severe Chronic Periodontitis|"Sites with probing PPD ≥ 3.5 mm~PAL-V ≥ 5 mm > 30% of sites~no Intervention provided~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
49925|NCT02280122|P1|Participant Flow|Moderate Chronic Periodontitis|"Sites with probing pocket depths (PPD) ≥ 3.5 mm~Attachment loss (PAL-V) 3-4 mm > 30% of sites, PAL-V ≥ 5 mm ≤ 30% of sites~no Intervention provided~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
49926|NCT02280122|O2|Outcome|Specificity: Periodontally Healthy|"PPD ≤ 3 mm~PAL-V ≤ 2 mm at < 30% of sites~BOP < 20%~No radiographically detectable bone loss: distance cemento-enamel junction to provided~no Intervention but aMMP-8 test~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
49927|NCT02280122|O1|Outcome|Sensitivity: Generalised Moderate/Severe Chronic Periodontitis|"Sites with probing pocket depths (PPD) ≥ 3.5 mm~Attachment loss (PAL-V) ≥ 3 mm > 30% of sites, PAL-V ≥ 5 mm ≤ 30% of sites~no Intervention provided~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
49928|NCT02280122|E2|Reported Event|Periodontally Healthy|"PPD ≤ 3 mm~PAL-V ≤ 2 mm at < 30% of sites~BOP < 20%~No radiographically detectable bone loss: distance cemento-enamel junction to provided~no Intervention but aMMP-8 test~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
49986|NCT02279641|O2|Outcome|Allopurinol: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
49987|NCT02279641|O1|Outcome|Allopurinol: Allopurinol Alone|Allopurinol 300 mg qd
49929|NCT02280122|E1|Reported Event|Generalized Moderate to Severe Chronic Periodontitis|"Sites with probing pocket depths (PPD) ≥ 3.5 mm~Attachment loss (PAL-V) 3-4 mm > 30% of sites, PAL-V ≥ 5 mm ≤ 30% of sites~no Intervention provided~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
49930|NCT02279667|B4|Baseline|Total|Total of all reporting groups
49931|NCT02279667|B3|Baseline|Group C|"st period - Four 200 mg tablets~nd period - One 800 mg tablet~rd period - 16 mL oral suspension 50 mg/mL"
49932|NCT02279667|B2|Baseline|Group B|"st period - One 800 mg tablet~nd period - 16 mL oral suspension 50 mg/mL~rd period - Four 200 mg tablets"
49933|NCT02279667|B1|Baseline|Group A|"st period - 16 mL oral suspension 50 mg/mL~nd period - Four 200 mg tablets~rd period - One 800 mg tablet"
49934|NCT02279667|P3|Participant Flow|Group C|"st period - Four 200 mg tablets~nd period - One 800 mg tablet~rd period - 16 mL oral suspension 50 mg/mL"
49935|NCT02279667|P2|Participant Flow|Group B|"st period - One 800 mg tablet~nd period - 16 mL oral suspension 50 mg/mL~rd period - Four 200 mg tablets"
49936|NCT02279667|P1|Participant Flow|Group A|"st period - 16 mL oral suspension 50 mg/mL~nd period - Four 200 mg tablets~rd period - One 800 mg tablet"
49937|NCT02279667|O3|Outcome|BIA 2-093 One 800 mg Tablet|BIA 2-093 (ESL, Eslicarbazepine acetate) - One 800 mg tablet
49938|NCT02279667|O2|Outcome|BIA 2-093 - Four 200 mg Tablets|BIA 2-093 (ESL, Eslicarbazepine acetate) - Four 200 mg tablets
49939|NCT02279667|O1|Outcome|BIA 2-093 16 mL Oral Suspension 50 mg/mL|BIA 2-093 (ESL, Eslicarbazepine acetate) 16 mL oral suspension 50 mg/mL
49940|NCT02279667|O3|Outcome|BIA 2-093 One 800 mg Tablet|BIA 2-093 (ESL, Eslicarbazepine acetate) - One 800 mg tablet
49941|NCT02279667|O2|Outcome|BIA 2-093 - Four 200 mg Tablets|BIA 2-093 (ESL, Eslicarbazepine acetate) - Four 200 mg tablets
49942|NCT02279667|O1|Outcome|BIA 2-093 16 mL Oral Suspension 50 mg/mL|BIA 2-093 (ESL, Eslicarbazepine acetate) 16 mL oral suspension 50 mg/mL
49943|NCT02279667|O3|Outcome|BIA 2-093 One 800 mg Tablet|BIA 2-093 (ESL, Eslicarbazepine acetate) - One 800 mg tablet
49944|NCT02279667|O2|Outcome|BIA 2-093 - Four 200 mg Tablets|BIA 2-093 (ESL, Eslicarbazepine acetate) - Four 200 mg tablets
49945|NCT02279667|O1|Outcome|BIA 2-093 16 mL Oral Suspension 50 mg/mL|BIA 2-093 (ESL, Eslicarbazepine acetate) 16 mL oral suspension 50 mg/mL
49946|NCT02279667|O3|Outcome|BIA 2-093 One 800 mg Tablet|BIA 2-093 (ESL, Eslicarbazepine acetate) - One 800 mg tablet
49947|NCT02279667|O2|Outcome|BIA 2-093 - Four 200 mg Tablets|BIA 2-093 (ESL, Eslicarbazepine acetate) - Four 200 mg tablets
49948|NCT02279667|O1|Outcome|BIA 2-093 16 mL Oral Suspension 50 mg/mL|BIA 2-093 (ESL, Eslicarbazepine acetate) 16 mL oral suspension 50 mg/mL
49949|NCT02279667|E4|Reported Event|Follow-up|Follow-up.
49950|NCT02279667|E3|Reported Event|BIA 2-093 One 800 mg Tablet|BIA 2-093, ESL, Eslicarbazepine acetate 800 mg tablet
49951|NCT02279667|E2|Reported Event|BIA 2-093 - Four 200 mg Tablets|BIA 2-093, ESL, Eslicarbazepine acetate 200 mg tablets
49952|NCT02279667|E1|Reported Event|BIA 2-093 16 mL Oral Suspension 50 mg/mL|BIA 2-093, ESL, Eslicarbazepine acetate oral suspension 50 mg/mL
49953|NCT02279641|B3|Baseline|Total|Total of all reporting groups
49954|NCT02279641|B2|Baseline|Sequence B|Days 1 to 7: 300 mg qd allopurinol; Days 8 to 14: 10 mg qd RDEA3170 + 300 mg qd allopurinol; Days 15 to 21: 10 mg qd RDEA3170
49955|NCT02279641|B1|Baseline|Sequence A|Days 1 to 7: 10 mg once daily (qd) RDEA3170; Days 8 to 14: 10 mg qd RDEA3170 + 300 mg qd allopurinol; Days 15 to 21: 300 mg qd allopurinol
49956|NCT02279641|P2|Participant Flow|RDEA3170 or Allopurinol Alone and in Combination (Sequence B)|Days 1 to 7: 300 mg qd allopurinol; Days 8 to 14: 10 mg qd RDEA3170 + 300 mg qd allopurinol; Days 15 to 21: 10 mg qd RDEA3170
49957|NCT02279641|P1|Participant Flow|RDEA3170 or Allopurinol Alone and in Combination (Sequence A)|Days 1 to 7: 10 mg once daily (qd) RDEA3170; Days 8 to 14: 10 mg qd RDEA3170 + 300 mg qd allopurinol; Days 15 to 21: 300 mg qd allopurinol
49958|NCT02279641|O2|Outcome|RDEA3170: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
49959|NCT02279641|O1|Outcome|RDEA3170: RDEA3170 Alone|RDEA3170 10 mg qd
49960|NCT02279641|O2|Outcome|RDEA3170: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
49961|NCT02279641|O1|Outcome|RDEA3170: RDEA3170 Alone|RDEA3170 10 mg qd
49962|NCT02279641|O2|Outcome|RDEA3170: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
49963|NCT02279641|O1|Outcome|RDEA3170: RDEA3170 Alone|RDEA3170 10 mg qd
49964|NCT02279641|O2|Outcome|RDEA3170: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
49965|NCT02279641|O1|Outcome|RDEA3170: RDEA3170 Alone|RDEA3170 10 mg qd
49966|NCT02279641|O3|Outcome|Allopurinol: Allopurinol Alone|Allopurinol 300 mg qd
49967|NCT02279641|O2|Outcome|Oxypurinol: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
49968|NCT02279641|O1|Outcome|RDEA3170: RDEA3170 Alone|RDEA3170 10 mg qd
49969|NCT02279641|O3|Outcome|Allopurinol: Allopurinol Alone|Allopurinol 300 mg qd
49970|NCT02279641|O2|Outcome|Oxypurinol: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
49971|NCT02279641|O1|Outcome|RDEA3170: RDEA3170 Alone|RDEA3170 10 mg qd
49972|NCT02279641|O6|Outcome|RDEA3170: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
49973|NCT02279641|O5|Outcome|RDEA3170: RDEA3170 Alone|RDEA3170 10 mg qd
49974|NCT02279641|O4|Outcome|Oxypurinol: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
49975|NCT02279641|O3|Outcome|Oxypurinol: Allopurinol Alone|Allopurinol 300 mg qd
49976|NCT02279641|O2|Outcome|Allopurinol: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
49977|NCT02279641|O1|Outcome|Allopurinol: Allopurinol Alone|Allopurinol 300 mg qd
49978|NCT02279641|O4|Outcome|Oxypurinol: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
49979|NCT02279641|O3|Outcome|Oxypurinol: Allopurinol Alone|Allopurinol 300 mg qd
49980|NCT02279641|O2|Outcome|Allopurinol: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
49981|NCT02279641|O1|Outcome|Allopurinol: Allopurinol Alone|Allopurinol 300 mg qd
49982|NCT02279641|O6|Outcome|RDEA3170: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
49983|NCT02279641|O5|Outcome|RDEA3170: RDEA3170 Alone|RDEA3170 10 mg qd
70155|NCT02139878|O2|Outcome|Placebo|240 ml placebo beverage
49992|NCT02279641|O5|Outcome|RDEA3170: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
49993|NCT02279641|O4|Outcome|Oxypurinol: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
49994|NCT02279641|O3|Outcome|Oxypurinol: Allopurinol Alone|Allopurinol 300 mg qd
49995|NCT02279641|O2|Outcome|Allopurinol: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
49996|NCT02279641|O1|Outcome|Allopurinol: Allopurinol Alone|Allopurinol 300 mg qd
49997|NCT02279641|O6|Outcome|RDEA3170: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
49998|NCT02279641|O5|Outcome|RDEA3170: RDEA3170 Alone|RDEA3170 10 mg qd
49999|NCT02279641|O4|Outcome|Oxypurinol: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
50000|NCT02279641|O3|Outcome|Oxypurinol: Allopurinol Alone|Allopurinol 300 mg qd
50001|NCT02279641|O2|Outcome|Allopurinol: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
50002|NCT02279641|O1|Outcome|Allopurinol: Allopurinol Alone|Allopurinol 300 mg qd
50003|NCT02279641|O4|Outcome|Oxypurinol: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
50004|NCT02279641|O3|Outcome|Oxypurinol: Allopurinol Alone|Allopurinol 300 mg qd
50005|NCT02279641|O2|Outcome|Allopurinol: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
50006|NCT02279641|O1|Outcome|Allopurinol: Allopurinol Alone|Allopurinol 300 mg qd
50007|NCT02279641|E3|Reported Event|Allopurinol 300 mg qd|Allopurinol 300 mg qd
50008|NCT02279641|E2|Reported Event|RDEA3170 10 mg qd + Allopurinol 300 mg qd|RDEA3170 10 mg qd + Allopurinol 300 mg qd
50009|NCT02279641|E1|Reported Event|RDEA3170 10 mg qd|RDEA3170 10 mg qd
50010|NCT02279420|B1|Baseline|Essential Study Sham Cross-over|Device: g-Cath EZ™ Suture Anchor Delivery Catheter This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended to evaluate the safety and efficacy of treating previous sham subjects in the Essential pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture anchors along with diet and exercise). Compliant sham subjects (those who attended all primary IDE follow-up visits AND who continue to meet eligibility criteria as described in this protocol) will be offered this active treatment after their 12 month unblinding visit in the Essential pivotal trial.
50011|NCT02279420|P1|Participant Flow|Essential Study Sham Cross-over|Eligible sham subjects from primary study
50012|NCT02279420|O1|Outcome|Essential Study Sham Cross-over|This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended to evaluate the safety and efficacy of treating previous sham subjects in the Essential pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture anchors along with diet and exercise). Compliant sham subjects (those who attended all primary IDE follow-up visits AND who continue to meet eligibility criteria as described in this protocol) will be offered this active treatment after their 12 month unblinding visit in the Essential pivotal trial.
50013|NCT02279420|E1|Reported Event|Essential Study Sham Cross-over|This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended to evaluate the safety and efficacy of treating previous sham subjects in the Essential pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture anchors along with diet and exercise). Compliant sham subjects (those who attended all primary IDE follow-up visits AND who continue to meet eligibility criteria as described in this protocol) will be offered this active treatment after their 12 month unblinding visit in the Essential pivotal trial.
50014|NCT02279407|B5|Baseline|Total|Total of all reporting groups
50015|NCT02279407|B4|Baseline|Placebo|Placebo to Epanova and placebo to Dapagliflozin
50016|NCT02279407|B3|Baseline|Dapagliflozin|Dapagliflozin 10 mg/day + placebo to Epanova
50017|NCT02279407|B2|Baseline|Epanova|Epanova 4 g/day + placebo to Dapagliflozin
50018|NCT02279407|B1|Baseline|Epanova + Dapagliflozin|Epanova 4 g/day + Dapagliflozin 10 mg/day
50019|NCT02279407|P4|Participant Flow|Placebo|Placebo to Epanova and placebo to Dapagliflozin
50020|NCT02279407|P3|Participant Flow|Epanova|Epanova 4 g/day + placebo to Dapagliflozin
50021|NCT02279407|P2|Participant Flow|Dapagliflozin|Dapagliflozin 10 mg/day + placebo to Epanova
50022|NCT02279407|P1|Participant Flow|Epanova + Dapagliflozin|Epanova 4 g/day + Dapagliflozin 10 mg/day
50023|NCT02279407|O3|Outcome|Epanova|Epanova 4 g/day + placebo to Dapagliflozin
50024|NCT02279407|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg/day + placebo to Epanova
50025|NCT02279407|O1|Outcome|Epanova + Dapagliflozin|Epanova 4 g/day + Dapagliflozin 10 mg/day
50026|NCT02279407|O2|Outcome|Placebo|Placebo to Epanova and placebo to Dapagliflozin
50027|NCT02279407|O1|Outcome|Epanova + Dapagliflozin|Epanova 4 g/day + Dapagliflozin 10 mg/day
50028|NCT02279407|E4|Reported Event|Placebo|Placebo to Epanova and placebo to Dapagliflozin
50029|NCT02279407|E3|Reported Event|Dapagliflozin|Dapagliflozin 10 mg/day + placebo to Epanova
50030|NCT02279407|E2|Reported Event|Epanova|Epanova 4 g/day + placebo to Dapagliflozin
50031|NCT02279407|E1|Reported Event|Epanova + Dapagliflozin|Epanova 4 g/day + Dapagliflozin 10 mg/day
50032|NCT02279108|B3|Baseline|Total|Total of all reporting groups
50033|NCT02279108|B2|Baseline|Isotope Detection Alone|"intradermal injection of 20 MBq of technetium 99 before breast surgery~isotope: One injection, 20 MBq techntium99, intradermal use"
50034|NCT02279108|B1|Baseline|Double Detection Indocyanine + Isotope|"intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery~indocyanine green: One injection, 2.5 milligrams per patient, intradermal use~isotope: One injection, 20 MBq techntium99, intradermal use"
50035|NCT02279108|P2|Participant Flow|Isotope Detection Alone|"intradermal injection of 20 MBq of technetium 99 before breast surgery~isotope: One injection, 20 MBq techntium99, intradermal use"
50036|NCT02279108|P1|Participant Flow|Double Detection Indocyanine + Isotope|"intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery~indocyanine green: One injection, 2.5 milligrams per patient, intradermal use~isotope: One injection, 20 MBq techntium99, intradermal use"
50037|NCT02279108|O2|Outcome|Isotope Detection Alone|"intradermal injection of 20 MBq of technetium 99 before breast surgery~isotope: One injection, 20 MBq techntium99, intradermal use"
50992|NCT02273050|O3|Outcome|Metformin + Placebo|Metformin 500 mg + Placebo
50038|NCT02279108|O1|Outcome|Double Detection Indocyanine + Isotope|"intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery~indocyanine green: One injection, 2.5 milligrams per patient, intradermal use~isotope: One injection, 20 MBq techntium99, intradermal use"
50039|NCT02279108|O2|Outcome|Isotope Detection Alone|"intradermal injection of 20 MBq of technetium 99 before breast surgery~isotope: One injection, 20 MBq techntium99, intradermal use"
50040|NCT02279108|O1|Outcome|Double Detection Indocyanine + Isotope|"intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery~indocyanine green: One injection, 2.5 milligrams per patient, intradermal use~isotope: One injection, 20 MBq techntium99, intradermal use"
50041|NCT02279108|O2|Outcome|Isotope Detection Alone|"intradermal injection of 20 MBq of technetium 99 before breast surgery~isotope: One injection, 20 MBq techntium99, intradermal use"
50042|NCT02279108|O1|Outcome|Double Detection Indocyanine + Isotope|"intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery~indocyanine green: One injection, 2.5 milligrams per patient, intradermal use~isotope: One injection, 20 MBq techntium99, intradermal use"
50043|NCT02279108|O2|Outcome|Isotope Detection Alone|"intradermal injection of 20 MBq of technetium 99 before breast surgery~isotope: One injection, 20 MBq techntium99, intradermal use"
50044|NCT02279108|O1|Outcome|Double Detection Indocyanine + Isotope|"intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery~indocyanine green: One injection, 2.5 milligrams per patient, intradermal use~isotope: One injection, 20 MBq techntium99, intradermal use"
50045|NCT02279108|O1|Outcome|Double Detection Indocyanine + Isotope|"intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery~indocyanine green: One injection, 2.5 milligrams per patient, intradermal use~isotope: One injection, 20 MBq techntium99, intradermal use"
50046|NCT02279108|O2|Outcome|Isotope Detection Alone|"intradermal injection of 20 MBq of technetium 99 before breast surgery~isotope: One injection, 20 MBq techntium99, intradermal use"
50047|NCT02279108|O1|Outcome|Double Detection Indocyanine + Isotope|"intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery~indocyanine green: One injection, 2.5 milligrams per patient, intradermal use~isotope: One injection, 20 MBq techntium99, intradermal use"
50048|NCT02279108|O2|Outcome|Isotope Detection Alone|"intradermal injection of 20 MBq of technetium 99 before breast surgery~isotope: One injection, 20 MBq techntium99, intradermal use"
50049|NCT02279108|O1|Outcome|Double Detection Indocyanine + Isotope|"intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery~indocyanine green: One injection, 2.5 milligrams per patient, intradermal use~isotope: One injection, 20 MBq techntium99, intradermal use"
50050|NCT02279108|O1|Outcome|Double Detection Indocyanine + Isotope|"intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery~indocyanine green: One injection, 2.5 milligrams per patient, intradermal use~isotope: One injection, 20 MBq techntium99, intradermal use"
50051|NCT02279108|O1|Outcome|Double Detection Indocyanine + Isotope|"intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery~indocyanine green: One injection, 2.5 milligrams per patient, intradermal use~isotope: One injection, 20 MBq techntium99, intradermal use"
50052|NCT02279108|O1|Outcome|Double Detection Indocyanine + Isotope|"intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery~indocyanine green: One injection, 2.5 milligrams per patient, intradermal use~isotope: One injection, 20 MBq techntium99, intradermal use"
50053|NCT02279108|O2|Outcome|Isotope Detection Alone|"intradermal injection of 20 MBq of technetium 99 before breast surgery~isotope: One injection, 20 MBq techntium99, intradermal use"
50054|NCT02279108|O1|Outcome|Double Detection Indocyanine + Isotope|"intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery~indocyanine green: One injection, 2.5 milligrams per patient, intradermal use~isotope: One injection, 20 MBq techntium99, intradermal use"
50055|NCT02279108|E2|Reported Event|Isotope Detection Alone|"intradermal injection of 20 MBq of technetium 99 before breast surgery~isotope: One injection, 20 MBq techntium99, intradermal use"
50056|NCT02279108|E1|Reported Event|Double Detection Indocyanine + Isotope|"intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery~indocyanine green: One injection, 2.5 milligrams per patient, intradermal use~isotope: One injection, 20 MBq techntium99, intradermal use"
50057|NCT02279082|B1|Baseline|DFN-02 (Single Arm, Open Label)|"Active DFN-02~DFN-02: Active Experimental Drug"
50058|NCT02279082|P1|Participant Flow|DFN-02|"Active DFN-02 (Nasal Sumatriptan 10mg)~DFN-02: Active Experimental Drug"
50059|NCT02279082|O1|Outcome|DFN-02|"Active DFN-02~DFN-02: Active Experimental Drug"
50060|NCT02279082|E1|Reported Event|DFN-02 (Single Arm, Open Label)|"Active DFN-02~DFN-02: Active Experimental Drug"
50061|NCT02278783|B1|Baseline|All Patients|
50062|NCT02278783|P1|Participant Flow|All Patients|
50063|NCT02278783|O1|Outcome|All Patients|
50064|NCT02278783|O1|Outcome|All Patients|
50065|NCT02278783|O1|Outcome|All Patients|
50066|NCT02278783|O1|Outcome|All Patients|
50067|NCT02278783|E1|Reported Event|All Patients|
50068|NCT02278640|B1|Baseline|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy~Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
50069|NCT02278640|P1|Participant Flow|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy~Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
50070|NCT02278640|O1|Outcome|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy~Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
50071|NCT02278640|O1|Outcome|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy~Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
50993|NCT02273050|O2|Outcome|Saxagliptin + Placebo|Saxagliptin 5 mg + Placebo
50072|NCT02278640|O1|Outcome|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy~Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
50073|NCT02278640|O1|Outcome|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy~Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
50074|NCT02278640|E1|Reported Event|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy~Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
50075|NCT02278614|B3|Baseline|Total|Total of all reporting groups
50076|NCT02278614|B2|Baseline|Xalacom|"Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops~Xalacom: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container."
50077|NCT02278614|B1|Baseline|T2347|"T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops~T2347: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers."
50078|NCT02278614|P2|Participant Flow|Xalacom|"Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops~Xalacom: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container."
50079|NCT02278614|P1|Participant Flow|T2347|"T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops~T2347: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers."
50080|NCT02278614|O2|Outcome|Xalacom|"Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops~Xalacom: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container."
50081|NCT02278614|O1|Outcome|T2347|"T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops~T2347: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers."
50082|NCT02278614|E2|Reported Event|Xalacom|"Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops~Xalacom: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container."
50083|NCT02278614|E1|Reported Event|T2347|"T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops~T2347: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers."
50084|NCT02278562|B4|Baseline|Total|Total of all reporting groups
50085|NCT02278562|B3|Baseline|Placebo 1 and 2|"Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months~placebo: placebo capsules and injection"
50086|NCT02278562|B2|Baseline|Actos|"Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and 30 mg of Actos in capsules administered orally 1 capsule per day for 3 months~actos: 30 mg capsules; administered orally 1 capsule per day for 12 weeks (3 months)"
50087|NCT02278562|B1|Baseline|Anakinra|"100 mg of Anakinra in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months~anakinra: 100 mg in syringes; administered subcutaneously 3 times a week for 12 weeks (3 months)"
50088|NCT02278562|P3|Participant Flow|Placebo 1 and 2|"Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months~placebo: placebo capsules and injection"
50089|NCT02278562|P2|Participant Flow|Actos|"Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and 30 mg of Actos in capsules administered orally 1 capsule per day for 3 months~actos: 30 mg capsules; administered orally 1 capsule per day for 12 weeks (3 months)"
50090|NCT02278562|P1|Participant Flow|Anakinra|"100 mg of Anakinra in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months~anakinra: 100 mg in syringes; administered subcutaneously 3 times a week for 12 weeks (3 months)"
50091|NCT02278562|O3|Outcome|Placebo 1 and 2|"Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months~placebo: placebo capsules and injection"
50092|NCT02278562|O2|Outcome|Actos|"Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and 30 mg of Actos in capsules administered orally 1 capsule per day for 3 months~actos: 30 mg capsules; administered orally 1 capsule per day for 12 weeks (3 months)"
50093|NCT02278562|O1|Outcome|Anakinra|"100 mg of Anakinra in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months~anakinra: 100 mg in syringes; administered subcutaneously 3 times a week for 12 weeks (3 months)"
50094|NCT02278562|O3|Outcome|Placebo 1 and 2|"Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months~placebo: placebo capsules and injection"
50095|NCT02278562|O2|Outcome|Actos|"Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and 30 mg of Actos in capsules administered orally 1 capsule per day for 3 months~actos: 30 mg capsules; administered orally 1 capsule per day for 12 weeks (3 months)"
50096|NCT02278562|O1|Outcome|Anakinra|"100 mg of Anakinra in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months~anakinra: 100 mg in syringes; administered subcutaneously 3 times a week for 12 weeks (3 months)"
50097|NCT02278562|O3|Outcome|Placebo 1 and 2|"Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months~placebo: placebo capsules and injection"
50098|NCT02278562|O2|Outcome|Actos|"Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and 30 mg of Actos in capsules administered orally 1 capsule per day for 3 months~actos: 30 mg capsules; administered orally 1 capsule per day for 12 weeks (3 months)"
50099|NCT02278562|O1|Outcome|Anakinra|"100 mg of Anakinra in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months~anakinra: 100 mg in syringes; administered subcutaneously 3 times a week for 12 weeks (3 months)"
50161|NCT02277769|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50100|NCT02278562|E3|Reported Event|Placebo 1 and 2|"Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months~placebo: placebo capsules and injection"
50101|NCT02278562|E2|Reported Event|Actos|"Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and 30 mg of Actos in capsules administered orally 1 capsule per day for 3 months~actos: 30 mg capsules; administered orally 1 capsule per day for 12 weeks (3 months)"
50102|NCT02278562|E1|Reported Event|Anakinra|"100 mg of Anakinra in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months~anakinra: 100 mg in syringes; administered subcutaneously 3 times a week for 12 weeks (3 months)"
50103|NCT02278484|B1|Baseline|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
50104|NCT02278484|P1|Participant Flow|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
50105|NCT02278484|O1|Outcome|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
50106|NCT02278484|O1|Outcome|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
50107|NCT02278484|O1|Outcome|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
50108|NCT02278484|O1|Outcome|Balloon Sinus Dilation|Balloon Sinus Dilation Using XprESS and PathAssist Devices.
50109|NCT02278484|E1|Reported Event|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
50110|NCT02278146|B3|Baseline|Total|Total of all reporting groups
50111|NCT02278146|B2|Baseline|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
50112|NCT02278146|B1|Baseline|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
50113|NCT02278146|P2|Participant Flow|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
50114|NCT02278146|P1|Participant Flow|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
50115|NCT02278146|O2|Outcome|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
50116|NCT02278146|O1|Outcome|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
50117|NCT02278146|O2|Outcome|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
50118|NCT02278146|O1|Outcome|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
50119|NCT02278146|O2|Outcome|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
50120|NCT02278146|O1|Outcome|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
50121|NCT02278146|E2|Reported Event|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
50122|NCT02278146|E1|Reported Event|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
50123|NCT02278003|B3|Baseline|Total|Total of all reporting groups
50124|NCT02278003|B2|Baseline|Children Not Going Under Sedation|"A control group of children of similar age and undergoing similar minor therapeutic procedures will be recruited to perform memory.~memory test"
50125|NCT02278003|B1|Baseline|Children Going Under Sedation With Propofol|"Children who will undergo sedation as part of their clinical management and give them a memory encoding task during propofol infusion to measure the effects of sedation. The mere task of naming a picture will encode that picture into memory. When the anesthesia has worn off (at approximately 1 hour later), children will be given a memory recognition task to measure the amnesic effects of propofol.~measure the amnesic effects of propofol.~memory test~Propofol"
50126|NCT02278003|P2|Participant Flow|Children Not Going Under Sedation|"A control group of children of similar age and undergoing similar minor therapeutic procedures will be recruited to perform memory.~memory test"
50127|NCT02278003|P1|Participant Flow|Children Going Under Sedation With Propofol|"Children who will undergo sedation as part of their clinical management and give them a memory encoding task during propofol infusion to measure the effects of sedation. The mere task of naming a picture will encode that picture into memory. When the anesthesia has worn off (at approximately 1 hour later), children will be given a memory recognition task to measure the amnesic effects of propofol.~measure the amnesic effects of propofol.~memory test~Propofol"
50128|NCT02278003|O2|Outcome|Children Not Going Under Sedation|"A control group of children of similar age and undergoing similar minor therapeutic procedures will be recruited to perform memory.~memory test"
50129|NCT02278003|O1|Outcome|Children Going Under Sedation With Propofol|"Children who will undergo sedation as part of their clinical management and give them a memory encoding task during propofol infusion to measure the effects of sedation. The mere task of naming a picture will encode that picture into memory. When the anesthesia has worn off (at approximately 1 hour later), children will be given a memory recognition task to measure the amnesic effects of propofol.~measure the amnesic effects of propofol.~memory test~Propofol"
50130|NCT02278003|O2|Outcome|Children Not Going Under Sedation|"A control group of children of similar age and undergoing similar minor therapeutic procedures will be recruited to perform memory.~memory test"
50994|NCT02273050|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg + Metformin 500 mg
50131|NCT02278003|O1|Outcome|Children Going Under Sedation With Propofol|"Children who will undergo sedation as part of their clinical management and give them a memory encoding task during propofol infusion to measure the effects of sedation. The mere task of naming a picture will encode that picture into memory. When the anesthesia has worn off (at approximately 1 hour later), children will be given a memory recognition task to measure the amnesic effects of propofol.~measure the amnesic effects of propofol.~memory test~Propofol"
50132|NCT02278003|E2|Reported Event|Children Not Going Under Sedation|"A control group of children of similar age and undergoing similar minor therapeutic procedures will be recruited to perform memory.~memory test"
50133|NCT02278003|E1|Reported Event|Children Going Under Sedation With Propofol|"Children who will undergo sedation as part of their clinical management and give them a memory encoding task during propofol infusion to measure the effects of sedation. The mere task of naming a picture will encode that picture into memory. When the anesthesia has worn off (at approximately 1 hour later), children will be given a memory recognition task to measure the amnesic effects of propofol.~measure the amnesic effects of propofol.~memory test~Propofol"
50134|NCT02277769|B4|Baseline|Total|Total of all reporting groups
50135|NCT02277769|B3|Baseline|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50136|NCT02277769|B2|Baseline|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50137|NCT02277769|B1|Baseline|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50138|NCT02277769|P3|Participant Flow|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50139|NCT02277769|P2|Participant Flow|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50140|NCT02277769|P1|Participant Flow|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50141|NCT02277769|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50142|NCT02277769|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50143|NCT02277769|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50144|NCT02277769|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50145|NCT02277769|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50146|NCT02277769|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50147|NCT02277769|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50148|NCT02277769|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50149|NCT02277769|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50150|NCT02277769|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50151|NCT02277769|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50152|NCT02277769|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50153|NCT02277769|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50154|NCT02277769|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50155|NCT02277769|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50156|NCT02277769|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50157|NCT02277769|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50158|NCT02277769|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50159|NCT02277769|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50160|NCT02277769|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50162|NCT02277769|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50163|NCT02277769|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50164|NCT02277769|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50165|NCT02277769|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50166|NCT02277769|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50167|NCT02277769|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50168|NCT02277769|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50169|NCT02277769|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50170|NCT02277769|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50171|NCT02277769|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50172|NCT02277769|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50173|NCT02277769|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50174|NCT02277769|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50175|NCT02277769|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50176|NCT02277769|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50177|NCT02277769|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50178|NCT02277769|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50179|NCT02277769|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50180|NCT02277769|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50181|NCT02277769|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50182|NCT02277769|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50183|NCT02277769|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50184|NCT02277769|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50185|NCT02277769|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50186|NCT02277769|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50187|NCT02277769|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50188|NCT02277769|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50189|NCT02277769|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50190|NCT02277769|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50191|NCT02277769|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50192|NCT02277769|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50193|NCT02277769|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50194|NCT02277769|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50195|NCT02277769|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50196|NCT02277769|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50197|NCT02277769|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50198|NCT02277769|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50199|NCT02277769|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50200|NCT02277769|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50201|NCT02277769|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50202|NCT02277769|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50203|NCT02277769|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50204|NCT02277769|E3|Reported Event|Dupilumab 300 mg qw|Participants exposed to Dupilumab 300 mg qw for 16 weeks (mean exposure of 15 weeks).
50205|NCT02277769|E2|Reported Event|Dupilumab 300 mg q2w|Participants exposed to Dupilumab 300 mg alternating with placebo qw for 16 weeks (mean exposure of 15 weeks).
50206|NCT02277769|E1|Reported Event|Placebo|Participants exposed to Placebo (for Dupilumab) for 16 weeks (mean exposure of 14 weeks)
50207|NCT02277743|B4|Baseline|Total|Total of all reporting groups
50208|NCT02277743|B3|Baseline|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50209|NCT02277743|B2|Baseline|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50210|NCT02277743|B1|Baseline|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50211|NCT02277743|P3|Participant Flow|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50212|NCT02277743|P2|Participant Flow|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50213|NCT02277743|P1|Participant Flow|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50214|NCT02277743|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50215|NCT02277743|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50216|NCT02277743|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50217|NCT02277743|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50218|NCT02277743|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50219|NCT02277743|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50220|NCT02277743|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50221|NCT02277743|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50222|NCT02277743|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50223|NCT02277743|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50224|NCT02277743|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50225|NCT02277743|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50226|NCT02277743|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50360|NCT02276612|O2|Outcome|E/C/F/TAF (≥ 18 Years of Age)|E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
50227|NCT02277743|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50228|NCT02277743|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50229|NCT02277743|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50230|NCT02277743|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50231|NCT02277743|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50232|NCT02277743|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50233|NCT02277743|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50234|NCT02277743|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50235|NCT02277743|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50236|NCT02277743|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50237|NCT02277743|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50238|NCT02277743|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50239|NCT02277743|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50240|NCT02277743|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50241|NCT02277743|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50242|NCT02277743|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50243|NCT02277743|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50244|NCT02277743|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50245|NCT02277743|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50246|NCT02277743|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50247|NCT02277743|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50248|NCT02277743|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50249|NCT02277743|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50250|NCT02277743|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50251|NCT02277743|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50252|NCT02277743|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50253|NCT02277743|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50254|NCT02277743|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50255|NCT02277743|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50256|NCT02277743|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50257|NCT02277743|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50258|NCT02277743|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
74634|NCT02116972|E1|Reported Event|FX006 16 mg|Single 5 mL IA injection
50259|NCT02277743|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50260|NCT02277743|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50261|NCT02277743|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50262|NCT02277743|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50263|NCT02277743|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50264|NCT02277743|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50265|NCT02277743|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50266|NCT02277743|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50267|NCT02277743|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50268|NCT02277743|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50269|NCT02277743|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50270|NCT02277743|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50271|NCT02277743|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50272|NCT02277743|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50273|NCT02277743|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50274|NCT02277743|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50275|NCT02277743|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
50276|NCT02277743|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
50277|NCT02277743|E3|Reported Event|Dupilumab 300 mg qw|Participants exposed to Dupilumab 300 mg qw for 16 weeks (mean exposure of 15 weeks).
50278|NCT02277743|E2|Reported Event|Dupilumab 300 mg q2w|Participants exposed to Dupilumab 300 mg alternating with placebo qw for 16 weeks (mean exposure of 15 weeks).
50279|NCT02277743|E1|Reported Event|Placebo|Participants exposed to Placebo (for Dupilumab) for 16 weeks (mean exposure of 14 weeks)
50280|NCT02277691|B1|Baseline|TAK-536TCH|"For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.~For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast."
50281|NCT02277691|P1|Participant Flow|TAK-536TCH|"For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.~For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast."
50282|NCT02277691|O1|Outcome|TAK-536TCH|"For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.~For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast."
50283|NCT02277691|O1|Outcome|TAK-536TCH|"For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.~For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast."
50284|NCT02277691|O1|Outcome|TAK-536TCH|"For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.~For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast."
50330|NCT02277119|O3|Outcome|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
50285|NCT02277691|O1|Outcome|TAK-536TCH|"For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.~For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast."
50286|NCT02277691|O1|Outcome|TAK-536TCH|"For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.~For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast."
50287|NCT02277691|O1|Outcome|TAK-536TCH|"For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.~For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast."
50288|NCT02277691|O1|Outcome|TAK-536TCH|"For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.~For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast."
50289|NCT02277691|E1|Reported Event|TAK-536TCH|"For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.~For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast."
50290|NCT02277639|B3|Baseline|Total|Total of all reporting groups
50291|NCT02277639|B2|Baseline|Immunodeficiency / Dysregulation|"Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells. Reduced intensity conditioning will include Busulfan, Fludarbine, Cyclophosphamide followed by stem cell infusion.~CD3+/CD19+ delpletion using CliniMACs device follwing reduced intensity conditioning: Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells."
50292|NCT02277639|B1|Baseline|Bone Marrow Failure Syndrome|"Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells. Reduced intensity conditioning will include Busulfan, Fludarbine, Cyclophosphamide followed by stem cell infusion.~CD3+/CD19+ delpletion using CliniMACs device follwing reduced intensity conditioning: Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells."
50293|NCT02277639|P2|Participant Flow|Immunodeficiency / Dysregulation|"Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells. Reduced intensity conditioning will include Busulfan, Fludarbine, Cyclophosphamide followed by stem cell infusion.~CD3+/CD19+ delpletion using CliniMACs device follwing reduced intensity conditioning: Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells."
50294|NCT02277639|P1|Participant Flow|Bone Marrow Failure Syndrome|"Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells. Reduced intensity conditioning will include Busulfan, Fludarbine, Cyclophosphamide followed by stem cell infusion.~CD3+/CD19+ delpletion using CliniMACs device follwing reduced intensity conditioning: Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells."
50295|NCT02277639|O2|Outcome|Immunodeficiency / Dysregulation|"Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells. Reduced intensity conditioning will include Busulfan, Fludarbine, Cyclophosphamide followed by stem cell infusion.~CD3+/CD19+ delpletion using CliniMACs device follwing reduced intensity conditioning: Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells."
50296|NCT02277639|O1|Outcome|Bone Marrow Failure Syndrome|"Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells. Reduced intensity conditioning will include Busulfan, Fludarbine, Cyclophosphamide followed by stem cell infusion.~CD3+/CD19+ delpletion using CliniMACs device follwing reduced intensity conditioning: Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells."
50297|NCT02277639|E2|Reported Event|Immunodeficiency / Dysregulation|"Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells. Reduced intensity conditioning will include Busulfan, Fludarbine, Cyclophosphamide followed by stem cell infusion.~CD3+/CD19+ delpletion using CliniMACs device follwing reduced intensity conditioning: Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells."
50298|NCT02277639|E1|Reported Event|Bone Marrow Failure Syndrome|"Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells. Reduced intensity conditioning will include Busulfan, Fludarbine, Cyclophosphamide followed by stem cell infusion.~CD3+/CD19+ delpletion using CliniMACs device follwing reduced intensity conditioning: Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells."
50299|NCT02277626|B1|Baseline|Total Number of Participants|
50331|NCT02277119|O2|Outcome|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
50300|NCT02277626|P2|Participant Flow|ElectroFlo First Then Vest|"Experimental: ElectroFlo 5000, then VEST 15 Patients were recruited from the Cystic Fibrosis Program at Stanford. All 15 patients were randomized to a sequence of ElectroFlo 5000 at one visit and during the second visit, they crossed-over to the Vest.~Electro Flo 5000: Airway clearance device"
50301|NCT02277626|P1|Participant Flow|Vest First Then ElectroFlo|"Experimental: VEST, then ElectroFlo 5000 15 Patients were recruited from the Cystic Fibrosis Program at Stanford. All 15 patients were randomized to a sequence of Vest at one visit and during the second visit, they crossed-over to the ElectroFlo 5000.~EnCourage Vest System: Airway Clearance Device"
50302|NCT02277626|O2|Outcome|ElectroFlo Arm|"ElectroFlo Arm~Electro Flo 5000: Airway clearance device"
50303|NCT02277626|O1|Outcome|Vest Arm|"Vest Arm~EnCourage Vest System: Airway Clearance Device"
50304|NCT02277626|O2|Outcome|ElectroFlo Arm|"ElectroFlo Arm~Electro Flo 5000: Airway clearance device"
50305|NCT02277626|O1|Outcome|Vest Arm|"Vest Arm~EnCourage Vest System: Airway Clearance Device"
50306|NCT02277626|O2|Outcome|Vest Arm|"Vest arm~Incourage Vest System: Airway Clearance Device"
50307|NCT02277626|O1|Outcome|ElectroFlo Arm|"ElectroFlo Arm~Electro Flo 5000: Airway clearance device"
50308|NCT02277626|O2|Outcome|ElectroFlo Arm|"ElectroFlo Arm~Electro Flo 5000: Airway clearance device"
50309|NCT02277626|O1|Outcome|Vest Arm|"Vest Arm~Incourage Vest System: Airway Clearance Device"
50310|NCT02277626|O2|Outcome|Elecflo Arm|"Elecflo Arm~Electro Flo 5000: Airway clearance device"
50311|NCT02277626|O1|Outcome|Vest|"VEST Arm~Incourage Vest System: Airway Clearance Device"
50312|NCT02277626|E2|Reported Event|ElectroFlo Arm|"ElectroFlo Arm~Electro Flo 5000: Airway clearance device"
50313|NCT02277626|E1|Reported Event|Vest Arm|"Vest arm~Incourage Vest System: Airway Clearance Device"
50314|NCT02277249|B3|Baseline|Total|Total of all reporting groups
50315|NCT02277249|B2|Baseline|Transabdominal Digoxin|"Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
50316|NCT02277249|B1|Baseline|Transvaginal Digoxin|"Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
50317|NCT02277249|P2|Participant Flow|Transabdominal Digoxin|"Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
50318|NCT02277249|P1|Participant Flow|Transvaginal Digoxin|"Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
50319|NCT02277249|O2|Outcome|Transabdominal Digoxin|"Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
50320|NCT02277249|O1|Outcome|Transvaginal Digoxin|"Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
50321|NCT02277249|E2|Reported Event|Transabdominal Digoxin|"Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
50322|NCT02277249|E1|Reported Event|Transvaginal Digoxin|"Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
50323|NCT02277119|B4|Baseline|Total|Total of all reporting groups
50324|NCT02277119|B3|Baseline|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
50325|NCT02277119|B2|Baseline|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
50326|NCT02277119|B1|Baseline|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
50327|NCT02277119|P3|Participant Flow|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
50328|NCT02277119|P2|Participant Flow|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
50329|NCT02277119|P1|Participant Flow|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
50841|NCT02273323|O2|Outcome|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
50332|NCT02277119|O1|Outcome|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
50333|NCT02277119|O3|Outcome|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
50334|NCT02277119|O2|Outcome|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
50335|NCT02277119|O1|Outcome|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
50336|NCT02277119|O3|Outcome|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
50337|NCT02277119|O2|Outcome|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
50338|NCT02277119|O1|Outcome|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
50339|NCT02277119|O3|Outcome|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
50340|NCT02277119|O2|Outcome|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
50341|NCT02277119|O1|Outcome|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
50342|NCT02277119|E3|Reported Event|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
50343|NCT02277119|E2|Reported Event|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
50344|NCT02277119|E1|Reported Event|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
50345|NCT02277093|B1|Baseline|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)~Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
50346|NCT02277093|P1|Participant Flow|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)~Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
50347|NCT02277093|O1|Outcome|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)~Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
50348|NCT02277093|O1|Outcome|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)~Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
50349|NCT02277093|O1|Outcome|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)~Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
50350|NCT02277093|O1|Outcome|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)~Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
50351|NCT02277093|O1|Outcome|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)~Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
50352|NCT02277093|E1|Reported Event|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)~Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
50353|NCT02276612|B3|Baseline|Total|Total of all reporting groups
50354|NCT02276612|B2|Baseline|E/C/F/TAF (≥ 18 Years of Age)|E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
50355|NCT02276612|B1|Baseline|E/C/F/TAF (12 - 17 Years of Age)|E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age
50356|NCT02276612|P2|Participant Flow|E/C/F/TAF (≥ 18 Years of Age)|"Participants 18 years of age or older received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.~Following completion of 48 weeks of treatment, eligible participants ≥ 18 years of age received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food during the open-label extension phase.~Note: Participants from Gilead Study GS-US-162-0112 were allowed to roll over into this Study GS-US-292-1515 even if they were 18 years or older at the time of screening."
50357|NCT02276612|P1|Participant Flow|E/C/F/TAF (12 - 17 Years of Age)|"Participants 12 - 17 years of age received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 48 weeks.~Following completion of 48 weeks of treatment, eligible participants 12 - 17 years of age received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food during the open-label extension phase."
50358|NCT02276612|O2|Outcome|E/C/F/TAF (≥ 18 Years of Age)|E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
50359|NCT02276612|O1|Outcome|E/C/F/TAF (12 - 17 Years of Age)|E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age
50361|NCT02276612|O1|Outcome|E/C/F/TAF (12 - 17 Years of Age)|E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age
50362|NCT02276612|O2|Outcome|E/C/F/TAF (≥ 18 Years of Age)|E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
50363|NCT02276612|O1|Outcome|E/C/F/TAF (12 - 17 Years of Age)|E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age
50364|NCT02276612|O2|Outcome|E/C/F/TAF (≥ 18 Years of Age)|E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
50365|NCT02276612|O1|Outcome|E/C/F/TAF (12 - 17 Years of Age)|E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age
50366|NCT02276612|O2|Outcome|E/C/F/TAF (≥ 18 Years of Age)|E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
50367|NCT02276612|O1|Outcome|E/C/F/TAF (12 - 17 Years of Age)|E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age
50368|NCT02276612|O2|Outcome|E/C/F/TAF (≥ 18 Years of Age)|E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
50369|NCT02276612|O1|Outcome|E/C/F/TAF (12 - 17 Years of Age)|E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age
50370|NCT02276612|O2|Outcome|E/C/F/TAF (≥ 18 Years of Age)|E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
50371|NCT02276612|O1|Outcome|E/C/F/TAF (12 - 17 Years of Age)|E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age
50372|NCT02276612|O2|Outcome|E/C/F/TAF (≥ 18 Years of Age)|E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
50373|NCT02276612|O1|Outcome|E/C/F/TAF (12 - 17 Years of Age)|E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age
50374|NCT02276612|E2|Reported Event|E/C/F/TAF (≥ 18 Years of Age)|"E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older.~Following completion of 48 weeks of treatment, eligible participants ≥ 18 years of age received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food during the open-label extension phase."
50375|NCT02276612|E1|Reported Event|E/C/F/TAF (12 - 17 Years of Age)|"E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age.~Following completion of 48 weeks of treatment, eligible participants 12 - 17 years of age received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food during the open-label extension phase."
50376|NCT02276560|B4|Baseline|Total|Total of all reporting groups
50377|NCT02276560|B3|Baseline|Cisplatin+Pemetrexed or Gemcitabine|"Adjuvant cisplatin (75mg/m2) D1, pemetrexed (500mgm2) D1 or; cisplatin (75 mg/m2),Gemcitabine (1000mg/m2) D1, 8 repeat each 21D cycle x 4~Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine: Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4"
50378|NCT02276560|B2|Baseline|Adjuvant Cisplatin,Nab-paclitaxel|"Adjuvant cisplatin (75mg/m2) D1, nab-paclitaxel (125 mg/m2)for D1, 8, 15 repeat each 28D x 2~Adjuvant Cisplatin,nab-paclitaxel: Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2"
50379|NCT02276560|B1|Baseline|Neoadjuvant Cisplatin,Nab-paclitaxel|"Neoadjuvant cisplatin (75 mg/m2) D1 and nab-paclitaxel (125 mg/m2) D1, 8, 15, repeat each 28D cycle x 3 and then surgery per standard of care~Neoadjuvant Cisplatin, nab-paclitaxel: Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery"
50380|NCT02276560|P3|Participant Flow|Cisplatin+Pemetrexed or Gemcitabine|"Adjuvant cisplatin (75mg/m2) D1, pemetrexed (500mgm2) D1 or; cisplatin (75 mg/m2),Gemcitabine (1000mg/m2) D1, 8 repeat each 21D cycle x 4~Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine: Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4"
50381|NCT02276560|P2|Participant Flow|Adjuvant Cisplatin,Nab-paclitaxel|"Adjuvant cisplatin (75mg/m2) D1, nab-paclitaxel (125 mg/m2)for D1, 8, 15 repeat each 28D x 2~Adjuvant Cisplatin,nab-paclitaxel: Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2"
50382|NCT02276560|P1|Participant Flow|Neoadjuvant Cisplatin,Nab-paclitaxel|"Neoadjuvant cisplatin (75 mg/m2) D1 and nab-paclitaxel (125 mg/m2) D1, 8, 15, repeat each 28D cycle x 3 and then surgery per standard of care~Neoadjuvant Cisplatin, nab-paclitaxel: Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery"
50383|NCT02276560|O3|Outcome|Cisplatin+Pemetrexed or Gemcitabine|"Adjuvant cisplatin (75mg/m2) D1, pemetrexed (500mgm2) D1 or; cisplatin (75 mg/m2),Gemcitabine (1000mg/m2) D1, 8 repeat each 21D cycle x 4~Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine: Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4"
50384|NCT02276560|O2|Outcome|Adjuvant Cisplatin,Nab-paclitaxel|"Adjuvant cisplatin (75mg/m2) D1, nab-paclitaxel (125 mg/m2)for D1, 8, 15 repeat each 28D x 2~Adjuvant Cisplatin,nab-paclitaxel: Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2"
50385|NCT02276560|O1|Outcome|Neoadjuvant Cisplatin,Nab-paclitaxel|"Neoadjuvant cisplatin (75 mg/m2) D1 and nab-paclitaxel (125 mg/m2) D1, 8, 15, repeat each 28D cycle x 3 and then surgery per standard of care~Neoadjuvant Cisplatin, nab-paclitaxel: Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery"
50386|NCT02276560|E3|Reported Event|Cisplatin+Pemetrexed or Gemcitabine|"Adjuvant cisplatin (75mg/m2) D1, pemetrexed (500mgm2) D1 or; cisplatin (75 mg/m2),Gemcitabine (1000mg/m2) D1, 8 repeat each 21D cycle x 4~Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine: Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4"
50387|NCT02276560|E2|Reported Event|Adjuvant Cisplatin,Nab-paclitaxel|"Adjuvant cisplatin (75mg/m2) D1, nab-paclitaxel (125 mg/m2)for D1, 8, 15 repeat each 28D x 2~Adjuvant Cisplatin,nab-paclitaxel: Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2"
50388|NCT02276560|E1|Reported Event|Neoadjuvant Cisplatin,Nab-paclitaxel|"Neoadjuvant cisplatin (75 mg/m2) D1 and nab-paclitaxel (125 mg/m2) D1, 8, 15, repeat each 28D cycle x 3 and then surgery per standard of care~Neoadjuvant Cisplatin, nab-paclitaxel: Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery"
50389|NCT02276274|B3|Baseline|Total|Total of all reporting groups
50390|NCT02276274|B2|Baseline|SYR-322-MET Fed Followed by SYR-322-MET Fasted|A single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fed condition on Day 1 of first intervention period, followed by at least 15 days of washout period, followed by a single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fasted condition on Day 1 of second intervention period.
50391|NCT02276274|B1|Baseline|SYR-322-MET Fasted Followed by SYR-322-MET Fed|A single dose of SYR-322 25 milligram (mg) and metformin hydrochloride 500 mg in 1 tablet, orally under fasted condition on Day 1 of first intervention period, followed by at least 15 days of washout period, followed by a single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fed condition on Day 1 of second intervention period.
50392|NCT02276274|P2|Participant Flow|SYR-322-MET Fed Followed by SYR-322-MET Fasted|A single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fed condition on Day 1 of first intervention period, followed by at least 15 days of washout period, followed by a single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fasted condition on Day 1 of second intervention period.
50393|NCT02276274|P1|Participant Flow|SYR-322-MET Fasted Followed by SYR-322-MET Fed|A single dose of SYR-322 25 milligram (mg) and metformin hydrochloride 500 mg in 1 tablet, orally under fasted condition on Day 1 of first intervention period, followed by at least 15 days of washout period, followed by a single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fed condition on Day 1 of second intervention period.
50394|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50395|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50396|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50397|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50398|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50399|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50400|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50401|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50402|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50403|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50404|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50405|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50406|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50407|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50408|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50409|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50410|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50411|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50412|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50413|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50414|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50415|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50416|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50417|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50418|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50419|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50420|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
74635|NCT02116803|B3|Baseline|Total|Total of all reporting groups
50421|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50422|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50423|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50424|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50425|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50426|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50427|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50428|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50429|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50430|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50431|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50432|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50433|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50434|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50435|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50436|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50437|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50438|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50439|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50440|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50441|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50442|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50443|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50444|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50445|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50446|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50447|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50448|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50449|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50450|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50451|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50452|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50453|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50454|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50455|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50842|NCT02273323|O1|Outcome|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
50456|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50457|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50458|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50459|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50460|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50461|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50462|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50463|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50464|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50465|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50466|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50467|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50468|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50469|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50470|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50471|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50472|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50473|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50474|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50475|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50476|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50477|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50478|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50479|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50480|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50481|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50482|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50483|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50484|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50485|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50486|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50487|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50488|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50489|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50490|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50990|NCT02273050|O2|Outcome|Saxagliptin + Placebo|Saxagliptin 5 mg + Placebo
50491|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50492|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50493|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50494|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50495|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50496|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50497|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50498|NCT02276274|E2|Reported Event|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
50499|NCT02276274|E1|Reported Event|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
50500|NCT02276222|B3|Baseline|Total|Total of all reporting groups
50501|NCT02276222|B2|Baseline|Spiriva 18 mcg QD Handihaler|"Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler~Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler"
50502|NCT02276222|B1|Baseline|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer"
50503|NCT02276222|P2|Participant Flow|Spiriva 18 mcg QD Handihaler|"Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler~Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler"
50504|NCT02276222|P1|Participant Flow|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer"
50505|NCT02276222|O2|Outcome|Spiriva 18 mcg QD Handihaler|"Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler~Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler"
50506|NCT02276222|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer"
50507|NCT02276222|O2|Outcome|Spiriva 18 mcg QD Handihaler|"Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler~Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler"
50508|NCT02276222|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer"
50509|NCT02276222|O2|Outcome|Spiriva 18 mcg QD Handihaler|"Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler~Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler"
50510|NCT02276222|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer"
50511|NCT02276222|O2|Outcome|Spiriva 18 mcg QD Handihaler|"Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler~Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler"
50512|NCT02276222|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer"
50513|NCT02276222|O2|Outcome|Spiriva 18 mcg QD Handihaler|"Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler~Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler"
50514|NCT02276222|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer"
50515|NCT02276222|O2|Outcome|Spiriva 18 mcg QD Handihaler|"Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler~Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler"
50516|NCT02276222|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer"
50517|NCT02276222|O2|Outcome|Spiriva 18 mcg QD Handihaler|"Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler~Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler"
50518|NCT02276222|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer"
50519|NCT02276222|O2|Outcome|Spiriva 18 mcg QD Handihaler|"Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler~Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler"
50520|NCT02276222|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer"
50521|NCT02276222|O2|Outcome|Spiriva 18 mcg QD Handihaler|"Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler~Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler"
50522|NCT02276222|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer"
50523|NCT02276222|O2|Outcome|Spiriva 18 mcg QD Handihaler|"Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler~Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler"
50524|NCT02276222|O1|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer"
50525|NCT02276222|E2|Reported Event|Spiriva 18 mcg QD Handihaler|"Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler~Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler"
50526|NCT02276222|E1|Reported Event|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer"
50527|NCT02276040|B1|Baseline|Exparalel|"Participants received Exparel (periarticular bupivicaine and liposomal bupivicaine).~periarticular bupivicaine and liposomal bupivicaine: Participants received Exparel (liposomal bupivacaine). Exparel is a FDA approved product. Exparel is an extended-release formulation of bupivacaine consisting of microscopic lipid-based particles that diffuse over an extended period. The result is pain relief that can last up to 96 hours after surgery. Extended-release liposomal bupivacaine-based analgesics were shown to provide extended pain relief and decrease opioid (pain medication) use. At the conclusion of the total joint arthroplasty procedure, Exparel was administered via injection into the joint (periarticular bupivicaine and liposomal bupivicaine)."
50528|NCT02276040|P1|Participant Flow|Exparel|"Participants received Exparel (periarticular bupivicaine and liposomal bupivicaine).~periarticular bupivicaine and liposomal bupivicaine: Participants received Exparel (liposomal bupivacaine). Exparel is a FDA approved product. Exparel is an extended-release formulation of bupivacaine consisting of microscopic lipid-based particles that diffuse over an extended period. The result is pain relief that can last up to 96 hours after surgery. Extended-release liposomal bupivacaine-based analgesics were shown to provide extended pain relief and decrease opioid (pain medication) use. At the conclusion of the total joint arthroplasty procedure, Exparel was administered via injection into the joint (periarticular bupivicaine and liposomal bupivicaine)."
50529|NCT02276040|O1|Outcome|Exparalel|"Participants received Exparel (periarticular bupivicaine and liposomal bupivicaine).~periarticular bupivicaine and liposomal bupivicaine: Participants received Exparel (liposomal bupivacaine). Exparel is a FDA approved product. Exparel is an extended-release formulation of bupivacaine consisting of microscopic lipid-based particles that diffuse over an extended period. The result is pain relief that can last up to 96 hours after surgery. Extended-release liposomal bupivacaine-based analgesics were shown to provide extended pain relief and decrease opioid (pain medication) use. At the conclusion of the total joint arthroplasty procedure, Exparel was administered via injection into the joint (periarticular bupivicaine and liposomal bupivicaine)."
50530|NCT02276040|E1|Reported Event|Exparel|"Participants received Exparel (periarticular bupivicaine and liposomal bupivicaine).~periarticular bupivicaine and liposomal bupivicaine: Participants received Exparel (liposomal bupivacaine). Exparel is a FDA approved product. Exparel is an extended-release formulation of bupivacaine consisting of microscopic lipid-based particles that diffuse over an extended period. The result is pain relief that can last up to 96 hours after surgery. Extended-release liposomal bupivacaine-based analgesics were shown to provide extended pain relief and decrease opioid (pain medication) use. At the conclusion of the total joint arthroplasty procedure, Exparel was administered via injection into the joint (periarticular bupivicaine and liposomal bupivicaine)."
50531|NCT02275767|B4|Baseline|Total|Total of all reporting groups
50532|NCT02275767|B3|Baseline|100% Cancellous FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA"
50533|NCT02275767|B2|Baseline|100% Cortical FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA"
50534|NCT02275767|B1|Baseline|Combination 50% Cortical/50% Cancellous FDBA|"Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)~50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA"
50535|NCT02275767|P3|Participant Flow|100% Cancellous FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA"
50536|NCT02275767|P2|Participant Flow|100% Cortical FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA"
50537|NCT02275767|P1|Participant Flow|Combination 50% Cortical/50% Cancellous FDBA|"Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)~50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA"
50538|NCT02275767|O3|Outcome|100% Cancellous FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA"
50539|NCT02275767|O2|Outcome|100% Cortical FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA"
50540|NCT02275767|O1|Outcome|Combination 50% Cortical/50% Cancellous FDBA|"Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)~50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA"
50541|NCT02275767|O3|Outcome|100% Cancellous FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA"
50542|NCT02275767|O2|Outcome|100% Cortical FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA"
50580|NCT02275481|O2|Outcome|SPIRIVA|"Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.~Tiotropium: Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®."
50543|NCT02275767|O1|Outcome|Combination 50% Cortical/50% Cancellous FDBA|"Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)~50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA"
50544|NCT02275767|E3|Reported Event|100% Cancellous FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA"
50545|NCT02275767|E2|Reported Event|100% Cortical FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA"
50546|NCT02275767|E1|Reported Event|Combination 50% Cortical/50% Cancellous FDBA|"Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)~50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA"
50547|NCT02275611|B5|Baseline|Total|Total of all reporting groups
50548|NCT02275611|B4|Baseline|Outpatient Treatment Placebo Spray|2 daily doses intranasal placebo spray for 12 weeks
50549|NCT02275611|B3|Baseline|Outpatient Treatment Intranasal Oxytocin Spray (Syntocinon)|2 daily doses intranasal oxytocin spray for 12 weeks
50550|NCT02275611|B2|Baseline|Intranasal Placebo Spray|Placebo spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks intranasal placebo spray. Inpatient Withdrawal
50551|NCT02275611|B1|Baseline|Intranasal Oxytocin Spray (Syntocinon)|Syntocinon Spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks intranasal oxytocin spray. Inpatient Withdrawal
50552|NCT02275611|P4|Participant Flow|Outpatient Treatment Placebo Spray|2 daily doses intranasal placebo spray for 12 weeks
50553|NCT02275611|P3|Participant Flow|Outpatient Treatment Intranasal Oxytocin Spray (Syntocinon)|2 daily doses intranasal oxytocin spray for 12 weeks
50554|NCT02275611|P2|Participant Flow|Placebo Comparator: Intranasal Placebo Spray|Placebo spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks Inpatient Withdrawal
50555|NCT02275611|P1|Participant Flow|Active Comparator:Intranasal Oxytocin Spray (Syntocinon Spray)|"Syntocinon Spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks.~Inpatient Withdrawal"
50556|NCT02275611|O2|Outcome|Outpatient Treatment Placebo Spray|2 daily doses intranasal placebo spray for 12 weeks
50557|NCT02275611|O1|Outcome|Outpatient Treatment Intranasal Oxytocin Spray (Syntocinon)|2 daily doses intranasal oxytocin spray for 12 weeks
50558|NCT02275611|O2|Outcome|Intranasal Placebo Spray|Placebo spray 3-4 doses daily inpatient
50559|NCT02275611|O1|Outcome|Intranasal Oxytocin Spray (Syntocinon Spray)|Syntocinon Spray 3-4 doses daily inpatient
50560|NCT02275611|O2|Outcome|Intranasal Placebo Spray|"Placebo spray 3-4 doses daily inpatient~intranasal oxytocin spray: Administration of oxytocin in a nasal spray~Intranasal Placebo Spray: Intranasal Placebo Spray"
50561|NCT02275611|O1|Outcome|Intranasal Oxytocin Spray (Syntocinon Spray)|"Syntocinon Spray 3-4 doses daily inpatient~intranasal oxytocin spray: Administration of oxytocin in a nasal spray"
50562|NCT02275611|E4|Reported Event|Outpatient Treatment Placebo Spray|2 daily doses intranasal placebo spray for 12 weeks
50563|NCT02275611|E3|Reported Event|Outpatient Treatment Intranasal Oxytocin Spray (Syntocinon)|2 daily doses intranasal oxytocin spray for 12 weeks
50564|NCT02275611|E2|Reported Event|Intranasal Placebo Spray|"Placebo spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks~intranasal oxytocin spray: Administration of oxytocin in a nasal spray~Intranasal Placebo Spray: Intranasal Placebo Spray"
50565|NCT02275611|E1|Reported Event|Intranasal Oxytocin Spray (Syntocinon Spray)|"Syntocinon Spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks~intranasal oxytocin spray: Administration of oxytocin in a nasal spray"
50566|NCT02275546|B1|Baseline|All Randomized Participants|
50567|NCT02275546|P2|Participant Flow|No Applicator (Manual)→Applicator|In Treatment Period 1, participants manually inserted the vaginal ring using their fingers only. In Treatment Period 2, participants used the applicator to insert the vaginal ring.
50568|NCT02275546|P1|Participant Flow|Applicator→No Applicator (Manual)|In Treatment Period 1, participants used the applicator to insert the vaginal ring. In Treatment Period 2 participants manually inserted the vaginal ring using their fingers only.
50569|NCT02275546|O2|Outcome|No Applicator (Manual)|Participants manually inserted the vaginal ring using their fingers only.
50570|NCT02275546|O1|Outcome|Applicator|Participants used the applicator to insert the vaginal ring.
50571|NCT02275546|O2|Outcome|No Applicator (Manual)|Participants manually inserted the vaginal ring using their fingers only.
50572|NCT02275546|O1|Outcome|Applicator|Participants used the applicator to insert the vaginal ring.
50573|NCT02275546|E2|Reported Event|No Applicator (Manual)|Participants manually inserted the vaginal ring using their fingers only.
50574|NCT02275546|E1|Reported Event|Applicator|Participants used the applicator to insert the vaginal ring.
50575|NCT02275481|B3|Baseline|Total|Total of all reporting groups
50576|NCT02275481|B2|Baseline|SPIRIVA|"Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.~Tiotropium: Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®."
50577|NCT02275481|B1|Baseline|BROVANA|"Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor~Arformoterol tartrate inhalation solution: Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor"
50578|NCT02275481|P2|Participant Flow|SPIRIVA|"Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.~Tiotropium: Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®."
50579|NCT02275481|P1|Participant Flow|BROVANA|"Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor~Arformoterol tartrate inhalation solution: Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor"
50581|NCT02275481|O1|Outcome|BROVANA|"Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor~Arformoterol tartrate inhalation solution: Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor"
50582|NCT02275481|E2|Reported Event|SPIRIVA|"Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.~Tiotropium: Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®."
50583|NCT02275481|E1|Reported Event|BROVANA|"Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor~Arformoterol tartrate inhalation solution: Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor"
50584|NCT02275364|B1|Baseline|Overall|Participants were randomized to receive either Marketed Nasal Strip or Placebo Nasal Strip (to be applied for up to two hours in either of the first two scans only). During the third scanning session, Marketed Nasal Strip was applied for approximately 20 minutes after administration of a Marketed Decongestant.
50585|NCT02275364|P2|Participant Flow|Sequence 2|In the sequence 1 of the crossover part of the study, participants were randomized to receive marketed strip first (period 1) followed by marketed strip (period 2). The marketed strip was applied for up to two hours for the first scanning sessions, and then removed and the placebo strip applied for the second scanning session. The strip was removed and participants applied the nasal spray (period 3) and then after approximately 30 minutes, applied the marketed nasal strip for the third scanning session (period 4). There was no washout for period 3, as treatment B i.e. marketed nasal strip, was added in period 4 to the nasal decongestant spray that was applied in period 3
50586|NCT02275364|P1|Participant Flow|Sequence 1|In the sequence 1 of the crossover part of the study, participants were randomized to receive placebo strip first (period 1) followed by marketed strip (period 2). The placebo strip was applied for up to two hours for the first scanning sessions, and then removed and the marketed strip applied for the second scanning session. The strip was removed and participants applied the nasal spray (period 3) and then after approximately 30 minutes, applied the marketed nasal strip for the third scanning session (period 4). There was no washout for period 3, as treatment B i.e. marketed nasal strip, was added in period 4 to the nasal decongestant spray that was applied in period 3
50587|NCT02275364|O1|Outcome|Marketed Nasal Strip Plus Decongestant|Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
50588|NCT02275364|O2|Outcome|Placebo Strip|Placebo nasal strip to be applied for up to two hours in either of the first two scans only.
50589|NCT02275364|O1|Outcome|Test Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
50590|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
50591|NCT02275364|O1|Outcome|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
50592|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
50593|NCT02275364|O1|Outcome|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
50594|NCT02275364|O4|Outcome|Marketed Nasal Strip Plus Decongestant|Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
50595|NCT02275364|O3|Outcome|Decongestant|A marketed nasal decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
50596|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
50597|NCT02275364|O1|Outcome|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
50598|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
50599|NCT02275364|O1|Outcome|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
50600|NCT02275364|O4|Outcome|Marketed Nasal Strip Plus Decongestant|Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
50601|NCT02275364|O3|Outcome|Decongestant|A nasal decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
50602|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
50603|NCT02275364|O1|Outcome|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
50604|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
50605|NCT02275364|O1|Outcome|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
50606|NCT02275364|O4|Outcome|Test Nasal Strip Plus Decongestant|Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
50607|NCT02275364|O3|Outcome|Decongestant|A Nasal Decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
50608|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
50609|NCT02275364|O1|Outcome|Test Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, in either of the first two sessions
50835|NCT02273323|O2|Outcome|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
50610|NCT02275364|E4|Reported Event|Marketed Nasal Strip Plus Decongestant|Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
50611|NCT02275364|E3|Reported Event|Decongestant|A Nasal Decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
50612|NCT02275364|E2|Reported Event|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
50613|NCT02275364|E1|Reported Event|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
50614|NCT02275156|B4|Baseline|Total|Total of all reporting groups
50615|NCT02275156|B3|Baseline|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50616|NCT02275156|B2|Baseline|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50617|NCT02275156|B1|Baseline|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50618|NCT02275156|P3|Participant Flow|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50619|NCT02275156|P2|Participant Flow|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50620|NCT02275156|P1|Participant Flow|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50621|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50622|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50623|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50624|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50625|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50626|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50627|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50628|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50629|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50630|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50631|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50632|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50633|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50634|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50635|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50636|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50637|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50638|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50639|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50640|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50641|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50642|NCT02275156|E4|Reported Event|Evolocumab 140 mg - Total|Participants received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50643|NCT02275156|E3|Reported Event|Evolocumab 140 mg - ESRD Requiring Hemodialysis|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50644|NCT02275156|E2|Reported Event|Evolocumab 140 mg - Severe RI|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50645|NCT02275156|E1|Reported Event|Evolocumab 140 mg - Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
50646|NCT02275052|B1|Baseline|UMEC/VI 62.5/25 mcg and Placebo in One of the Two Sequences|Par. received a sequence consisting of the following 2 treatments: One inhalation of UMEC/VI 62.5/25 mcg or placebo once daily using a DPI. Each treatment was self-administered in the morning for 12 weeks. The treatments were separated by a 12 to 17 day washout period; all par. were provided with albuterol for use on an ‘as needed’ basis throughout the run-in, washout and study treatment periods while on investigational product.
50647|NCT02275052|P4|Participant Flow|Period 2: Placebo Then UMEC/VI 62.5/25 µg|Participants received placebo and then UMEC/VI 62.5 µg/25 µg each morning (once daily) as one inhalation via the DPI for 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed' basis throughout the run-in, washout and study treatment periods while on investigational product.
50648|NCT02275052|P3|Participant Flow|Period 2: UMEC/VI 62.5/25 µg Then Placebo|Participants received UMEC/VI 62.5 µg/25 µg and then Placebo each morning (once daily) as one inhalation via the Dry Powder Inhaler (DPI) for 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed (prn)' basis throughout the run-in, washout and study treatment periods while on investigational product.
50649|NCT02275052|P2|Participant Flow|UMEC/VI 62.5/25 µg Then Placebo|Participants received UMEC/ VI 62.5 µg/25 µg and then placebo each morning (once daily) as one inhalation via the DPI for 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed' basis throughout the run-in, washout and study treatment periods while on investigational product.
50650|NCT02275052|P1|Participant Flow|Placebo Then UMEC/VI 62.5/25 µg|Participants received Placebo and then umeclidinium (UMEC)/ vilanterol trifenatate (VI) 62.5 micrograms (µg)/25 µg each morning (once daily) as one inhalation via the Dry Powder Inhaler (DPI) for 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed (prn)' basis throughout the run-in, washout and study treatment periods while on investigational product.
50651|NCT02275052|O2|Outcome|Placebo|Participants received placebo each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed' basis throughout the run-in, washout and study treatment periods while on investigational product.
50652|NCT02275052|O1|Outcome|UMEC/VI 62.5/25 mcg|Participants received umeclidinium (UMEC)/ vilanterol trifenatate (VI) 62.5 mcg/25 mcg each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed (prn)' basis throughout the run-in, washout and study treatment periods while on investigational product.
50653|NCT02275052|O2|Outcome|Placebo|Participants received placebo each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed' basis throughout the run-in, washout and study treatment periods while on investigational product.
50654|NCT02275052|O1|Outcome|UMEC/VI 62.5/25 mcg|Participants received umeclidinium (UMEC)/ vilanterol trifenatate (VI) 62.5 mcg/25 mcg each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed (prn)' basis throughout the run-in, washout and study treatment periods while on investigational product.
50655|NCT02275052|O2|Outcome|Placebo|Participants received placebo each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed' basis throughout the run-in, washout and study treatment periods while on investigational product.
50656|NCT02275052|O1|Outcome|UMEC/VI 62.5/25 mcg|Participants received umeclidinium (UMEC)/ vilanterol trifenatate (VI) 62.5 mcg/25 mcg each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed (prn)' basis throughout the run-in, washout and study treatment periods while on investigational product.
50657|NCT02275052|O2|Outcome|Placebo|Participants received placebo each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed' basis throughout the run-in, washout and study treatment periods while on investigational product.
50658|NCT02275052|O1|Outcome|UMEC/VI 62.5/25 mcg|Participants received umeclidinium (UMEC)/ vilanterol trifenatate (VI) 62.5 mcg/25 mcg each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed (prn)' basis throughout the run-in, washout and study treatment periods while on investigational product.
50659|NCT02275052|E2|Reported Event|Placebo|Participants received placebo each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed' basis throughout the run-in, washout and study treatment periods while on investigational product.
50660|NCT02275052|E1|Reported Event|UMEC/VI 62.5/25 mcg|Participants received umeclidinium (UMEC)/ vilanterol trifenatate (VI) 62.5 mcg/25 mcg each morning (once daily) as one inhalation via the Dry Powder Inhaler (DPI) in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed (prn)' basis throughout the run-in, washout and study treatment periods while on investigational product.
50661|NCT02274948|B3|Baseline|Total|Total of all reporting groups
50991|NCT02273050|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg + Metformin 500 mg
50662|NCT02274948|B2|Baseline|Placebo|"173 were randomized to receive placebo~Metformin and placebo were manufactured by the State Pharmaceutical Manufacturing Corporation, Sri Lanka and both tablets look similar except for the active pharmacological compound in one"
50663|NCT02274948|B1|Baseline|Metformin|"166 were randomized to receive Metformin. After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metformin (166) and placebo (173).~Children, 8 to 10.99 years received metformin 250mg daily for a week and increased to 250mg twice daily for a week and thereafter 500 mg twice daily. Eleven to 16 year old children received 500mg of metformin daily for one week and increased to 500mg twice daily for a week and thereafter 1g twice daily. Children were asked to take medication with their morning and evening meals to reduce gastro intestinal side effects and risk of hypoglycaemia"
50664|NCT02274948|P2|Participant Flow|Placebo|"A placebo tablet which is physically similar to metformin tablets will be given in a similar manner as described above (the placebo is manufactured by the same manufacturer, State Pharmaceutical Manufacturing Corporation)~Metformin: A dummy tablet similar to Metformin will be administer to the control group"
50665|NCT02274948|P1|Participant Flow|Metformin|"8-10.99 year old children will receive metformin. Initially children will be given 250mg of metformin daily for a week and increased to 250mg twice daily for a week and then to 500 mg twice daily there after. 11-16 year old children will receive 500mg of metformin daily initially for one week which will be increased to 500mg twice daily for a week and then to 1g twice daily. The medication will be continued for 12 months.~Metformin: A dummy tablet similar to Metformin will be administer to the control group"
50666|NCT02274948|O2|Outcome|Placebo|173 were randomized to receive placebo
50667|NCT02274948|O1|Outcome|Metformin|After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metformin (166)
50668|NCT02274948|O2|Outcome|Placebo|173 were randomized to receive placebo
50669|NCT02274948|O1|Outcome|Metformin|After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metformin (166)
50670|NCT02274948|O2|Outcome|Placebo|173 were randomized to receive placebo
50671|NCT02274948|O1|Outcome|Metformin|After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metformin (166)
50672|NCT02274948|O2|Outcome|Placebo|173 were randomized to receive placebo
50673|NCT02274948|O1|Outcome|Metformin|After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metforming (166)
50674|NCT02274948|O2|Outcome|Placebo|173 were randomized to receive placebo
50675|NCT02274948|O1|Outcome|Metformin|After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metformin (166)
50676|NCT02274948|E2|Reported Event|Placebo|"The placebo group was given medication in a similar manner and the number of tablets to be taken each occasion were similar to the treatment group~Children were asked to take medication with their morning and evening meals to reduce gastro intestinal side effects and risk of hypoglycaemia. Effects to medication were evaluated before each dose revision and was monitored for all possible adverse events."
50677|NCT02274948|E1|Reported Event|Metformin|"8-10.99 year old children received metformin. Initially children were given 250mg of metformin daily for a week and increased to 250mg twice daily for a week and then to 500 mg twice daily there after. 11-16 year old children received 500mg of metformin daily initially for one week increased to 500mg twice daily for a week and then to 1g twice daily.~Children were asked to take medication with their morning and evening meals to reduce gastro intestinal side effects and risk of hypoglycaemia. Effects to medication were evaluated before each dose revision and was monitored for all possible adverse events."
50678|NCT02274792|B1|Baseline|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
50679|NCT02274792|P1|Participant Flow|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
50680|NCT02274792|O1|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
50681|NCT02274792|O1|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
50682|NCT02274792|O1|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
50683|NCT02274792|O1|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
50684|NCT02274792|O1|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
50685|NCT02274792|E1|Reported Event|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
50686|NCT02274766|B3|Baseline|Total|Total of all reporting groups
50687|NCT02274766|B2|Baseline|ADS-5102 (Amantadine HCl Extended Release)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 13 weeks
50688|NCT02274766|B1|Baseline|Placebo|Placebo: oral capsules administered once nightly at bedtime for 13 weeks
50689|NCT02274766|P2|Participant Flow|ADS-5102 (Amantadine HCl Extended Release)|340 mg dose of ADS-5102 (amantadine hydrochloride [HCl] extended release): oral capsules administered once nightly at bedtime for 13 weeks
50690|NCT02274766|P1|Participant Flow|Placebo|Placebo: oral capsules administered once nightly at bedtime for 13 weeks
50691|NCT02274766|O2|Outcome|ADS-5102 (Amantadine HCl Extended Release)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 13 weeks
50692|NCT02274766|O1|Outcome|Placebo|Placebo: oral capsules administered once nightly at bedtime for 13 weeks
50836|NCT02273323|O1|Outcome|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
50693|NCT02274766|O2|Outcome|ADS-5102 (Amantadine HCl Extended Release)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 13 weeks
50694|NCT02274766|O1|Outcome|Placebo|Placebo: oral capsules administered once nightly at bedtime for 13 weeks
50695|NCT02274766|E2|Reported Event|ADS-5102 (Amantadine HCl Extended Release)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 13 weeks
50696|NCT02274766|E1|Reported Event|Placebo|Placebo: oral capsules administered once nightly at bedtime for 13 weeks
50697|NCT02274688|B3|Baseline|Total|Total of all reporting groups
50698|NCT02274688|B2|Baseline|Patient-centered Care Transition|"Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.~Will be blindly assessed."
50699|NCT02274688|B1|Baseline|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.~Will be blindly assessed."
50700|NCT02274688|P2|Participant Flow|Patient-centered Care Transition|"Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.~Will be blindly assessed."
50701|NCT02274688|P1|Participant Flow|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.~Will be blindly assessed."
50702|NCT02274688|O2|Outcome|Patient-centered Care Transition|"Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.~Will be blindly assessed."
50703|NCT02274688|O1|Outcome|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.~Will be blindly assessed."
50704|NCT02274688|O2|Outcome|Patient-centered Care Transition|"Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.~Will be blindly assessed."
50705|NCT02274688|O1|Outcome|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.~Will be blindly assessed."
50706|NCT02274688|O2|Outcome|Patient-centered Care Transition|"Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.~Will be blindly assessed."
50707|NCT02274688|O1|Outcome|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.~Will be blindly assessed."
50708|NCT02274688|O2|Outcome|Patient-centered Care Transition|"Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.~Will be blindly assessed."
50709|NCT02274688|O1|Outcome|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.~Will be blindly assessed."
50710|NCT02274688|O2|Outcome|Patient-centered Care Transition|"Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.~Will be blindly assessed."
50711|NCT02274688|O1|Outcome|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.~Will be blindly assessed."
50712|NCT02274688|O2|Outcome|Patient-centered Care Transition|"Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.~Will be blindly assessed."
50713|NCT02274688|O1|Outcome|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.~Will be blindly assessed."
50714|NCT02274688|O2|Outcome|Patient-centered Care Transition|"Case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.~Stepped Care Management: Case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements."
50715|NCT02274688|O1|Outcome|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.~Will be blindly assessed."
50716|NCT02274688|O2|Outcome|Patient-centered Care Transition|"Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.~Will be blindly assessed."
50717|NCT02274688|O1|Outcome|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.~Will be blindly assessed."
50718|NCT02274688|O2|Outcome|Patient-centered Care Transition|"Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.~Will be blindly assessed."
50719|NCT02274688|O1|Outcome|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.~Will be blindly assessed."
50720|NCT02274688|E2|Reported Event|Patient-centered Care Transition|"Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.~Will be blindly assessed."
50721|NCT02274688|E1|Reported Event|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.~Will be blindly assessed."
50722|NCT02274675|B1|Baseline|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
50723|NCT02274675|P1|Participant Flow|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
50724|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
76904|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
50725|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
50726|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
50727|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
50728|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
50729|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
50730|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
50731|NCT02274675|E1|Reported Event|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
50732|NCT02274558|B4|Baseline|Total|Total of all reporting groups
50733|NCT02274558|B3|Baseline|Placebo-Controlled Valbenazine 80mg|Participants received valbenazine 40mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
50734|NCT02274558|B2|Baseline|Placebo-Controlled Valbenazine 40mg|Participants received valbenazine 40mg capsule once daily for 6 weeks.
50735|NCT02274558|B1|Baseline|Placebo-Controlled Placebo|Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.
50736|NCT02274558|P3|Participant Flow|Placebo-Controlled Valbenazine 80mg|Participants received valbenazine 40mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
50737|NCT02274558|P2|Participant Flow|Placebo-Controlled Valbenazine 40mg|Participants received valbenazine 40mg capsule once daily for 6 weeks.
50738|NCT02274558|P1|Participant Flow|Placebo-Controlled Placebo|Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.
50739|NCT02274558|O3|Outcome|Valbenazine 80mg|Participants received valbenazine 40mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
50740|NCT02274558|O2|Outcome|Valbenazine 40mg|Participants received valbenazine 40mg capsule once daily for 6 weeks.
50741|NCT02274558|O1|Outcome|Placebo|Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.
50742|NCT02274558|O3|Outcome|Valbenazine 80mg|Participants received valbenazine 40mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
50743|NCT02274558|O2|Outcome|Valbenazine 40mg|Participants received valbenazine 40mg capsule once daily for 6 weeks.
50744|NCT02274558|O1|Outcome|Placebo|Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.
50745|NCT02274558|O3|Outcome|Valbenazine 40mg|Participants received valbenazine 40mg capsule once daily for 6 weeks.
50746|NCT02274558|O2|Outcome|Valbenazine 80mg|Participants received valbenazine 40mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
50747|NCT02274558|O1|Outcome|Placebo|Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.
50748|NCT02274558|E3|Reported Event|Valbenazine 80mg|Participants received valbenazine 40mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
50749|NCT02274558|E2|Reported Event|Valbenazine 40mg|Participants received valbenazine 40mg capsule once daily for 6 weeks.
50750|NCT02274558|E1|Reported Event|Placebo|Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.
50751|NCT02273973|B3|Baseline|Total|Total of all reporting groups
50752|NCT02273973|B2|Baseline|Placebo Comparator: Placebo + Letrozole|Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
50753|NCT02273973|B1|Baseline|Experimental: Taselisib + Letrozole|Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
50754|NCT02273973|P2|Participant Flow|Placebo Comparator: Placebo + Letrozole|Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
50755|NCT02273973|P1|Participant Flow|Experimental: Taselisib + Letrozole|Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
50756|NCT02273973|O2|Outcome|Placebo Comparator: Placebo + Letrozole|Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
50757|NCT02273973|O1|Outcome|Experimental: Taselisib + Letrozole|Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
50758|NCT02273973|O2|Outcome|Placebo Comparator: Placebo + Letrozole|Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
50759|NCT02273973|O1|Outcome|Experimental: Taselisib + Letrozole|Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
50760|NCT02273973|O2|Outcome|Placebo Comparator: Placebo + Letrozole|Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
50761|NCT02273973|O1|Outcome|Experimental: Taselisib + Letrozole|Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
50762|NCT02273973|O2|Outcome|Placebo Comparator: Placebo + Letrozole|Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
50763|NCT02273973|O1|Outcome|Experimental: Taselisib + Letrozole|Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
50764|NCT02273973|O2|Outcome|Placebo Comparator: Placebo + Letrozole|Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
50765|NCT02273973|O1|Outcome|Experimental: Taselisib + Letrozole|Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
50766|NCT02273973|O2|Outcome|Placebo Comparator: Placebo + Letrozole|Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
50767|NCT02273973|O1|Outcome|Experimental: Taselisib + Letrozole|Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
50768|NCT02273973|O2|Outcome|Placebo Comparator: Placebo + Letrozole|Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
50769|NCT02273973|O1|Outcome|Experimental: Taselisib + Letrozole|Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
50770|NCT02273973|O2|Outcome|Placebo Comparator: Placebo + Letrozole|Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
50771|NCT02273973|O1|Outcome|Experimental: Taselisib + Letrozole|Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
50772|NCT02273973|O2|Outcome|Placebo Comparator: Placebo + Letrozole|Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
50773|NCT02273973|O1|Outcome|Experimental: Taselisib + Letrozole|Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
50774|NCT02273973|O2|Outcome|Placebo Comparator: Placebo + Letrozole|Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
50775|NCT02273973|O1|Outcome|Experimental: Taselisib + Letrozole|Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
50776|NCT02273973|O2|Outcome|Placebo Comparator: Placebo + Letrozole|Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
50777|NCT02273973|O1|Outcome|Experimental: Taselisib + Letrozole|Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
50778|NCT02273973|O2|Outcome|Placebo Comparator: Placebo + Letrozole|Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
50779|NCT02273973|O1|Outcome|Experimental: Taselisib + Letrozole|Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
50780|NCT02273973|O2|Outcome|Placebo Comparator: Placebo + Letrozole|Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
50781|NCT02273973|O1|Outcome|Experimental: Taselisib + Letrozole|Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
50782|NCT02273973|O2|Outcome|Placebo Comparator: Placebo + Letrozole|Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
50783|NCT02273973|O1|Outcome|Experimental: Taselisib + Letrozole|Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
50784|NCT02273973|O2|Outcome|Placebo Comparator: Placebo + Letrozole|Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
50785|NCT02273973|O1|Outcome|Experimental: Taselisib + Letrozole|Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
50786|NCT02273973|O2|Outcome|Placebo Comparator: Placebo + Letrozole|Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
50787|NCT02273973|O1|Outcome|Experimental: Taselisib + Letrozole|Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
50788|NCT02273973|O2|Outcome|Placebo Comparator: Placebo + Letrozole|Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
50789|NCT02273973|O1|Outcome|Experimental: Taselisib + Letrozole|Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
50790|NCT02273973|O2|Outcome|Placebo Comparator: Placebo + Letrozole|Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
50791|NCT02273973|O1|Outcome|Experimental: Taselisib + Letrozole|Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
50792|NCT02273973|E2|Reported Event|Placebo Comparator: Placebo + Letrozole|Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
50793|NCT02273973|E1|Reported Event|Experimental: Taselisib + Letrozole|Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
50794|NCT02273908|B3|Baseline|Total|Total of all reporting groups
50795|NCT02273908|B2|Baseline|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care :no intervention
50796|NCT02273908|B1|Baseline|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care :no intervention
50797|NCT02273908|P2|Participant Flow|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention
50798|NCT02273908|P1|Participant Flow|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
50799|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care : No intervention
50800|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care : no intervention
50801|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
50802|NCT02273908|O2|Outcome|Other Analgesics|2.Patients will be treated for 8 weeks with other analgesics in usual care:no intervention
50803|NCT02273908|O1|Outcome|Pregabalin|1.Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
50804|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention
50805|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
50806|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention
50807|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
50808|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention
50809|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
50810|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
50811|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
50812|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
50813|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
50814|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
50815|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
50816|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
50817|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
50818|NCT02273908|E1|Reported Event|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care No intervention: The study is observational
50819|NCT02273752|B1|Baseline|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
50820|NCT02273752|P1|Participant Flow|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic therapeutic drug monitoring (TDM) on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
50837|NCT02273323|O2|Outcome|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
50838|NCT02273323|O1|Outcome|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
50839|NCT02273323|O2|Outcome|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
50840|NCT02273323|O1|Outcome|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
50821|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
50822|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
50823|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
50824|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
50825|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
50826|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
50827|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
50828|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
50829|NCT02273752|E1|Reported Event|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
50830|NCT02273323|B1|Baseline|All Study Participants|Participants who were randomised to either receive Tea first followed by Placebo or Placebo first followed by Tea
50831|NCT02273323|P2|Participant Flow|Placebo Then Tea|Subjects first received a single acute dose of placebo consisting of tea flavour, colouring and sugar. After a washout of at least 1 week, they received a single acute dose of black tea infusion containing approximately 400 mg flavonoids (expressed as gallic acid equivalents) with added sugar
50832|NCT02273323|P1|Participant Flow|Tea Then Placebo|Subjects first received a single acute dose of black tea infusion containing approximately 400 mg flavonoids (expressed as gallic acid equivalents) with added sugar. After a washout of at least 1 week, they received a single acute dose of placebo consisting of tea flavour, colouring and sugar.
50833|NCT02273323|O2|Outcome|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
50834|NCT02273323|O1|Outcome|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
50843|NCT02273323|O2|Outcome|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
50844|NCT02273323|O1|Outcome|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
50845|NCT02273323|E2|Reported Event|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
50846|NCT02273323|E1|Reported Event|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
50847|NCT02273310|B3|Baseline|Total|Total of all reporting groups
50848|NCT02273310|B2|Baseline|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
50849|NCT02273310|B1|Baseline|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention~Problem Solving Training for Disease Management"
50850|NCT02273310|P2|Participant Flow|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
50851|NCT02273310|P1|Participant Flow|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention~Problem Solving Training for Disease Management"
50852|NCT02273310|O1|Outcome|Families Taking Control|"Families participate in a 1 day Problem-Solving Skills training for disease management intervention~Problem-Solving Skills Training for Disease Management: Children and caregivers participated in a multi-family group to learn problem-solving skills as applied to disease management and school functioning in the context of sickle cell disease."
50853|NCT02273310|O2|Outcome|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
50854|NCT02273310|O1|Outcome|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention~Problem Solving Training for Disease Management"
50855|NCT02273310|O2|Outcome|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
50856|NCT02273310|O1|Outcome|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention~Problem Solving Training for Disease Management"
50857|NCT02273310|O2|Outcome|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
50858|NCT02273310|O1|Outcome|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention~Problem Solving Training for Disease Management"
50859|NCT02273310|E2|Reported Event|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
50860|NCT02273310|E1|Reported Event|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention~Problem Solving Training for Disease Management"
50861|NCT02273180|B3|Baseline|Total|Total of all reporting groups
50862|NCT02273180|B2|Baseline|Humalog|Humalog 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
50863|NCT02273180|B1|Baseline|SAR342434|SAR342434 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
50864|NCT02273180|P2|Participant Flow|Humalog|Humalog 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
50865|NCT02273180|P1|Participant Flow|SAR342434|SAR342434 100 Units(U)/mL subcutaneous (SC) injection, before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52.
50866|NCT02273180|O2|Outcome|Humalog|Humalog 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
50867|NCT02273180|O1|Outcome|SAR342434|SAR342434 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
50868|NCT02273180|O2|Outcome|Humalog|Humalog 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
50869|NCT02273180|O1|Outcome|SAR342434|SAR342434 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
50870|NCT02273180|O2|Outcome|Humalog|Humalog 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
50871|NCT02273180|O1|Outcome|SAR342434|SAR342434 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
50872|NCT02273180|O2|Outcome|Humalog|Humalog 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
50873|NCT02273180|O1|Outcome|SAR342434|SAR342434 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
50874|NCT02273180|O2|Outcome|Humalog|Humalog 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
50875|NCT02273180|O1|Outcome|SAR342434|SAR342434 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
50876|NCT02273180|O2|Outcome|Humalog|Humalog 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
50877|NCT02273180|O1|Outcome|SAR342434|SAR342434 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
50878|NCT02273180|O2|Outcome|Humalog|Humalog 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
50879|NCT02273180|O1|Outcome|SAR342434|SAR342434 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
50880|NCT02273180|O2|Outcome|Humalog|Humalog 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
50881|NCT02273180|O1|Outcome|SAR342434|SAR342434 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
50882|NCT02273180|O2|Outcome|Humalog|Humalog 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
50883|NCT02273180|O1|Outcome|SAR342434|SAR342434 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
50884|NCT02273180|E2|Reported Event|Humalog|Humalog 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
50885|NCT02273180|E1|Reported Event|SAR342434|SAR342434 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
50886|NCT02273167|B4|Baseline|Total|Total of all reporting groups
50887|NCT02273167|B3|Baseline|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
50888|NCT02273167|B2|Baseline|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
50889|NCT02273167|B1|Baseline|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
50890|NCT02273167|P3|Participant Flow|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
50891|NCT02273167|P2|Participant Flow|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
50892|NCT02273167|P1|Participant Flow|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
50893|NCT02273167|O3|Outcome|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
50894|NCT02273167|O2|Outcome|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
50895|NCT02273167|O1|Outcome|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
50896|NCT02273167|O3|Outcome|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
50897|NCT02273167|O2|Outcome|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
50898|NCT02273167|O1|Outcome|MOVIPREP, 2-Day Split-Dosing|MOVIPREP: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
50899|NCT02273167|O3|Outcome|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
50900|NCT02273167|O2|Outcome|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
50901|NCT02273167|O1|Outcome|MOVIPREP, 2-Day Split-Dosing|MOVIPREP: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
50902|NCT02273167|O3|Outcome|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
50903|NCT02273167|O2|Outcome|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
50904|NCT02273167|O1|Outcome|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
50905|NCT02273167|O3|Outcome|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
50906|NCT02273167|O2|Outcome|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
50907|NCT02273167|O1|Outcome|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
50908|NCT02273167|O3|Outcome|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
50909|NCT02273167|O2|Outcome|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
50910|NCT02273167|O1|Outcome|MOVIPREP, 2-Day Split-Dosing|MOVIPREP: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
50911|NCT02273167|E3|Reported Event|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
50912|NCT02273167|E2|Reported Event|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
50913|NCT02273167|E1|Reported Event|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
50914|NCT02273141|B3|Baseline|Total|Total of all reporting groups
50915|NCT02273141|B2|Baseline|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
50916|NCT02273141|B1|Baseline|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the moring of the day before colonoscopy).
50917|NCT02273141|P2|Participant Flow|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
50918|NCT02273141|P1|Participant Flow|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
50919|NCT02273141|O2|Outcome|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
50920|NCT02273141|O1|Outcome|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
50921|NCT02273141|O2|Outcome|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
50922|NCT02273141|O1|Outcome|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
50923|NCT02273141|O2|Outcome|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
50924|NCT02273141|O1|Outcome|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
50925|NCT02273141|O2|Outcome|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
50926|NCT02273141|O1|Outcome|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
50927|NCT02273141|O2|Outcome|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
50928|NCT02273141|O1|Outcome|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
50929|NCT02273141|O2|Outcome|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
79044|NCT02092961|O1|Outcome|FOSTA 100 MG PO BID|Dosing Group A
50930|NCT02273141|O1|Outcome|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
50931|NCT02273141|E2|Reported Event|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
50932|NCT02273141|E1|Reported Event|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
50933|NCT02273115|B5|Baseline|Total|Total of all reporting groups
50934|NCT02273115|B4|Baseline|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
50935|NCT02273115|B3|Baseline|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
50936|NCT02273115|B2|Baseline|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
50937|NCT02273115|B1|Baseline|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
50938|NCT02273115|P4|Participant Flow|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
50939|NCT02273115|P3|Participant Flow|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
50940|NCT02273115|P2|Participant Flow|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
50941|NCT02273115|P1|Participant Flow|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
50942|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
82201|NCT02074059|O6|Outcome|nCPAP Alone|nCPAP therapy alone
50943|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
50944|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
50945|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
50946|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
50947|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
50948|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
50949|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
50950|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
50951|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
50952|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
50953|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
50954|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
50955|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
50956|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
50957|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
50958|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
50959|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
50960|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
50961|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
50962|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
50963|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
50964|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
50965|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
50966|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
50967|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
50968|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
50969|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
50970|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
50971|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
50972|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
50973|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
50974|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
50975|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
50976|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
50977|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
50978|NCT02273115|E4|Reported Event|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
50979|NCT02273115|E3|Reported Event|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
50980|NCT02273115|E2|Reported Event|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
50981|NCT02273115|E1|Reported Event|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
50982|NCT02273050|B4|Baseline|Total|Total of all reporting groups
50983|NCT02273050|B3|Baseline|SAXAGLIPTIN 5MG QD + PLACEBO|
50984|NCT02273050|B2|Baseline|SAXAGLIPTIN 5MG QD + METFORMIN|
50985|NCT02273050|B1|Baseline|METFORMIN + PLACEBO 5MG QD|
50986|NCT02273050|P3|Participant Flow|SAXAGLIPTIN 5MG QD + PLACEBO|
50987|NCT02273050|P2|Participant Flow|SAXAGLIPTIN 5MG QD + METFORMIN|
50988|NCT02273050|P1|Participant Flow|METFORMIN + PLACEBO 5MG QD|
50989|NCT02273050|O3|Outcome|Metformin + Placebo|Metformin 500 mg + Placebo
50995|NCT02273050|O3|Outcome|Metformin + Placebo|Metformin 500 mg + Placebo
50996|NCT02273050|O2|Outcome|Saxagliptin + Placebo|Saxagliptin 5 mg + Placebo
50997|NCT02273050|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg + Metformin 500 mg
50998|NCT02273050|O3|Outcome|Metformin + Placebo|Metformin 500 mg + Placebo
50999|NCT02273050|O2|Outcome|Saxagliptin + Placebo|Saxagliptin 5 mg + Placebo
51000|NCT02273050|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg + Metformin 500 mg
51001|NCT02273050|O3|Outcome|Metformin + Placebo|Metformin 500 mg + Placebo
51002|NCT02273050|O2|Outcome|Saxagliptin + Placebo|Saxagliptin 5 mg + Placebo
51003|NCT02273050|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg + Metformin 500 mg
51004|NCT02273050|O3|Outcome|Metformin + Placebo|Metformin 500 mg + Placebo
51005|NCT02273050|O2|Outcome|Saxagliptin + Placebo|Saxagliptin 5 mg + Placebo
51006|NCT02273050|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg + Metformin 500 mg
51007|NCT02273050|O3|Outcome|Metformin + Placebo|Metformin 500 mg + Placebo
51008|NCT02273050|O2|Outcome|Saxagliptin + Placebo|Saxagliptin 5 mg + Placebo
51009|NCT02273050|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg + Metformin 500 mg
51010|NCT02273050|E3|Reported Event|SAXAGLIPTIN 5MG QD + PLACEBO|
51011|NCT02273050|E2|Reported Event|SAXAGLIPTIN 5MG QD + METFORMIN|
51012|NCT02273050|E1|Reported Event|METFORMIN + PLACEBO 5MG QD|
51013|NCT02272803|B3|Baseline|Total|Total of all reporting groups
51014|NCT02272803|B2|Baseline|Arm B: Lenalidomide + Dexamethasone|"Drug: Lenalidomide~Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug~Drug: Dexamethasone~Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug"
51015|NCT02272803|B1|Baseline|Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)|"Drug: Lenalidomide~Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug~Drug: Dexamethasone~Tablets, Oral 28 mg and Intravenous (IV) 8 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug~Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug~Biological: Elotuzumab (BMS-901608)~Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug~Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug"
51016|NCT02272803|P2|Participant Flow|Arm B: Lenalidomide + Dexamethasone|"Drug: Lenalidomide~Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug~Drug: Dexamethasone~Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug"
51017|NCT02272803|P1|Participant Flow|Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)|"Drug: Lenalidomide~Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug~Drug: Dexamethasone~Tablets, Oral 28 mg and Intravenous (IV) 8 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug~Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug~Biological: Elotuzumab (BMS-901608)~Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug~Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug"
51018|NCT02272803|O2|Outcome|Arm B: Lenalidomide + Dexamethasone|"Drug: Lenalidomide~Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug~Drug: Dexamethasone~Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug"
51019|NCT02272803|O1|Outcome|Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)|"Drug: Lenalidomide~Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug~Drug: Dexamethasone~Tablets, Oral 28 mg and Intravenous (IV) 8 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug~Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug~Biological: Elotuzumab (BMS-901608)~Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug~Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug"
51020|NCT02272803|O2|Outcome|Arm B: Lenalidomide + Dexamethasone|"Drug: Lenalidomide~Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug~Drug: Dexamethasone~Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug"
51021|NCT02272803|O1|Outcome|Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)|"Drug: Lenalidomide~Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug~Drug: Dexamethasone~Tablets, Oral 28 mg and Intravenous (IV) 8 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug~Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug~Biological: Elotuzumab (BMS-901608)~Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug~Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug"
83996|NCT02061358|B5|Baseline|180 mg UV-4B|UV-4B 180 mg oral, single dose
51022|NCT02272803|O2|Outcome|Arm B: Lenalidomide + Dexamethasone|"Drug: Lenalidomide~Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug~Drug: Dexamethasone~Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug"
51023|NCT02272803|O1|Outcome|Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)|"Drug: Lenalidomide~Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug~Drug: Dexamethasone~Tablets, Oral 28 mg and Intravenous (IV) 8 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug~Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug~Biological: Elotuzumab (BMS-901608)~Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug~Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug"
51024|NCT02272803|O1|Outcome|Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)|"Drug: Lenalidomide~Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug~Drug: Dexamethasone~Tablets, Oral 28 mg and Intravenous (IV) 8 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug~Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug~Biological: Elotuzumab (BMS-901608)~Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug~Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug"
51025|NCT02272803|E2|Reported Event|Lenalidomide + Dexamethasone|"Drug: Lenalidomide~Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug~Drug: Dexamethasone~Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug"
51026|NCT02272803|E1|Reported Event|Lenalidomide + Dexamethasone + Elotuzumab|"Drug: Lenalidomide~Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug~Drug: Dexamethasone~Tablets, Oral 28 mg and Intravenous (IV) 8 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug~Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug~Biological: Elotuzumab (BMS-901608)~Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug~Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug"
51027|NCT02272725|B3|Baseline|Total|Total of all reporting groups
51028|NCT02272725|B2|Baseline|Ibuprofen|"Each tablet containing 400mg of ibuprofen~Ibuprofen: Ibuprofen"
51029|NCT02272725|B1|Baseline|Placebo|"tasteless and inert tablets~Placebo: Tasteless and inert visually identical (to ibuprofen) pills"
51030|NCT02272725|P2|Participant Flow|Ibuprofen|"Each tablet containing 400mg of ibuprofen~Ibuprofen: Ibuprofen"
51031|NCT02272725|P1|Participant Flow|Placebo|"tasteless and inert tablets~Placebo: Tasteless and inert visually identical (to ibuprofen) pills"
51032|NCT02272725|O2|Outcome|Ibuprofen|"Each tablet containing 400mg of ibuprofen~Ibuprofen: Ibuprofen"
51033|NCT02272725|O1|Outcome|Placebo|"tasteless and inert tablets~Placebo: Tasteless and inert visually identical (to ibuprofen) pills"
51034|NCT02272725|O2|Outcome|Ibuprofen|"Each tablet containing 400mg of ibuprofen~Ibuprofen: Ibuprofen"
51035|NCT02272725|O1|Outcome|Placebo|"tasteless and inert tablets~Placebo: Tasteless and inert visually identical (to ibuprofen) pills"
51036|NCT02272725|O2|Outcome|Ibuprofen|"Each tablet containing 400mg of ibuprofen~Ibuprofen: Ibuprofen"
51037|NCT02272725|O1|Outcome|Placebo|"tasteless and inert tablets~Placebo: Tasteless and inert visually identical (to ibuprofen) pills"
51038|NCT02272725|E2|Reported Event|Ibuprofen|"Each tablet containing 400mg of ibuprofen~Ibuprofen: Ibuprofen"
51039|NCT02272725|E1|Reported Event|Placebo|"tasteless and inert tablets~Placebo: Tasteless and inert visually identical (to ibuprofen) pills"
51040|NCT02271984|B1|Baseline|All Subjects|Subjects randomized to receive a single oral dose of MSC2499550A formulation at 20 milligram per kilogram (mg/kg) dispersed in water, current praziquantel (PZQ) formulation (Cysticide®) at 40 mg/kg with water under fed conditions; MSC2499550A formulation at 10 mg/kg or 30 mg/kg dispersed in water under fed condition; MSC2499550A formulation at 20 mg/kg dispersed in water under fasted condition; MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth without water under fed condition in one of the intervention periods.
51041|NCT02271984|P12|Participant Flow|BAEC2D|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water (B) in first intervention period followed by a single oral dose of MSC2499550A ODT formulation at 20 mg/kg dispersed in water (A) in second intervention period followed by a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth (E) in third intervention followed by a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water (C2) in fourth intervention under fed conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water (D) in fifth intervention period under fasted conditions. There was a wash-out period of at least 7 days between each intervention period.
51072|NCT02271984|O5|Outcome|Treatment D|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water in fasted condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51073|NCT02271984|O4|Outcome|Treatment C2|Subjects received a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51042|NCT02271984|P11|Participant Flow|BADEC2|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water (B) in first intervention period followed by a single oral dose of MSC2499550A ODT formulation at 20 mg/kg dispersed in water (A) in second intervention period under fed conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water (D) in third intervention period under fasted conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth (E) in fourth intervention period followed by a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water (C2) in fifth intervention period under fed conditions. There was a wash-out period of at least 7 days between each intervention period.
51043|NCT02271984|P10|Participant Flow|BAC2DE|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water (B) in first intervention period followed by a single oral dose of MSC2499550A ODT formulation at 20 mg/kg dispersed in water (A) in second intervention period followed by a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water (C2) in third intervention period under fed conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water (D) in fourth intervention period under fasted conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth (E) in fifth intervention period under fed condition. There was a wash-out period of at least 7 days between each intervention period.
51044|NCT02271984|P9|Participant Flow|ABEC2D|Subjects received a single oral dose of MSC2499550A ODT formulation at 20 mg/kg dispersed in water (A) in first intervention period followed by single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water (B) in second intervention period followed by a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth (E) in third intervention period followed by a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water (C2) in fourth intervention period under fed conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water (D) in fifth intervention period under fasted conditions. There was a wash-out period of at least 7 days between each intervention period.
51045|NCT02271984|P8|Participant Flow|ABDEC2|Subjects received a single oral dose of MSC2499550A ODT formulation at 20 mg/kg dispersed in water (A) in first intervention period followed by single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water (B) in second intervention period under fed conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water (D) in third intervention period under fasted conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth (E) in fourth intervention period followed by a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water (C2) in fifth intervention period under fed conditions. There was a wash-out period of at least 7 days between each intervention period.
51046|NCT02271984|P7|Participant Flow|ABC2DE|Subjects received a single oral dose of MSC2499550A ODT formulation at 20 mg/kg dispersed in water (A) in first intervention period followed by single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water (B) in second intervention period followed by a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water (C2) in third intervention period under fed conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water (D) in fourth intervention period under fasted conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth (E) in fifth intervention period under fed condition. There was a wash-out period of at least 7 days between each intervention period.
51047|NCT02271984|P6|Participant Flow|BAEC1D|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water (B) in first intervention period followed by a single oral dose of MSC2499550A ODT formulation at 20 mg/kg dispersed in water (A) in second intervention period followed by a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth (E) in third intervention period followed by a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water (C1) in fourth intervention period under fed conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water (D) in fifth intervention period under fasted conditions. There was a wash-out period of at least 7 days between each intervention period.
51048|NCT02271984|P5|Participant Flow|BADEC1|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water (B) in first intervention period followed by a single oral dose of MSC2499550A ODT formulation at 20 mg/kg dispersed in water (A) in second intervention period under fed conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water (D) in third intervention period under fasted conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth (E) in fourth intervention period followed by a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water (C1) in fifth intervention period under fed conditions. There was a wash-out period of at least 7 days between each intervention period.
51049|NCT02271984|P4|Participant Flow|BAC1DE|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water (B) in first intervention period followed by a single oral dose of MSC2499550A ODT formulation at 20 mg/kg dispersed in water (A) in second intervention period followed by a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water (C1) in third intervention period under fed conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water (D) in fourth intervention period under fasted conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth (E) in fifth intervention period under fed condition. There was a wash-out period of at least 7 days between each intervention period.
51050|NCT02271984|P3|Participant Flow|ABEC1D|Subjects received a single oral dose of MSC2499550A ODT formulation at 20 mg/kg dispersed in water (A) in first intervention period followed by single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water (B) in second intervention period followed by a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth (E) in third intervention period followed by a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water (C1) in fourth intervention period under fed conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water (D) in fifth intervention period under fasted conditions. There was a wash-out period of at least 7 days between each intervention period.
51074|NCT02271984|O3|Outcome|Treatment C1|Subjects received a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51051|NCT02271984|P2|Participant Flow|ABDEC1|Subjects received a single oral dose of MSC2499550A ODT formulation at 20 mg/kg dispersed in water (A) in first intervention period followed by single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water (B) in second intervention period under fed condition followed by a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water (D) in third intervention period under fasted conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth (E) in fourth intervention period followed by a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water (C1) in fifth intervention period under fed conditions. There was a wash-out period of at least 7 days between each intervention period.
51052|NCT02271984|P1|Participant Flow|ABC1DE|Subjects received a single oral dose of MSC2499550A oral disintegrating tablet (ODT) formulation at 20 milligram per kilogram (mg/kg) dispersed in water (A) in first intervention period followed by single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water (B) in second intervention period followed by a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water (C1) in third intervention period under fed conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water (D) in fourth intervention period under fasted conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth (E) in fifth intervention period under fed condition. There was a wash-out period of at least 7 days between each intervention period.
51053|NCT02271984|O6|Outcome|Treatment E|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth without water under fed conditions in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51054|NCT02271984|O5|Outcome|Treatment D|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water in fasted condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51055|NCT02271984|O4|Outcome|Treatment C2|Subjects received a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51056|NCT02271984|O3|Outcome|Treatment C1|Subjects received a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51057|NCT02271984|O2|Outcome|Treatment B|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water, under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51058|NCT02271984|O1|Outcome|Treatment A|Subjects received a single oral dose of MSC2499550A formulation at 20 milligram per kilogram (mg/kg) dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each intervention period.
51059|NCT02271984|O6|Outcome|Treatment E|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth without water under fed conditions in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51060|NCT02271984|O5|Outcome|Treatment D|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water in fasted condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51061|NCT02271984|O4|Outcome|Treatment C2|Subjects received a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51062|NCT02271984|O3|Outcome|Treatment C1|Subjects received a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51063|NCT02271984|O2|Outcome|Treatment B|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water, under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51064|NCT02271984|O1|Outcome|Treatment A|Subjects received a single oral dose of MSC2499550A formulation at 20 milligram per kilogram (mg/kg) dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each intervention period.
51065|NCT02271984|O6|Outcome|Treatment E|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth without water under fed conditions in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51066|NCT02271984|O5|Outcome|Treatment D|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water in fasted condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51067|NCT02271984|O4|Outcome|Treatment C2|Subjects received a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51068|NCT02271984|O3|Outcome|Treatment C1|Subjects received a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51069|NCT02271984|O2|Outcome|Treatment B|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water, under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51070|NCT02271984|O1|Outcome|Treatment A|Subjects received a single oral dose of MSC2499550A formulation at 20 milligram per kilogram (mg/kg) dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each intervention period.
51071|NCT02271984|O6|Outcome|Treatment E|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth without water under fed conditions in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51457|NCT02268214|O1|Outcome|Dapagliflozin 5 mg + Insulin|Dapagliflozin 5 mg oral tablet once daily for 24 weeks + background insulin
51075|NCT02271984|O2|Outcome|Treatment B|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water, under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51076|NCT02271984|O1|Outcome|Treatment A|Subjects received a single oral dose of MSC2499550A formulation at 20 milligram per kilogram (mg/kg) dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each intervention period.
51077|NCT02271984|O6|Outcome|Treatment E|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth without water under fed conditions in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51078|NCT02271984|O5|Outcome|Treatment D|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water in fasted condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51079|NCT02271984|O4|Outcome|Treatment C2|Subjects received a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51080|NCT02271984|O3|Outcome|Treatment C1|Subjects received a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51081|NCT02271984|O2|Outcome|Treatment B|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water, under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51082|NCT02271984|O1|Outcome|Treatment A|Subjects received a single oral dose of MSC2499550A formulation at 20 milligram per kilogram (mg/kg) dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each intervention period.
51083|NCT02271984|O6|Outcome|Treatment E|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth without water under fed conditions in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51084|NCT02271984|O5|Outcome|Treatment D|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water in fasted condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51085|NCT02271984|O4|Outcome|Treatment C2|Subjects received a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51086|NCT02271984|O3|Outcome|Treatment C1|Subjects received a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51087|NCT02271984|O2|Outcome|Treatment B|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water, under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51088|NCT02271984|O1|Outcome|Treatment A|Subjects received a single oral dose of MSC2499550A formulation at 20 milligram per kilogram (mg/kg) dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each intervention period.
51089|NCT02271984|O1|Outcome|Treatment A and B|Subjects received MSC2499550A formulation at 20 mg/kg dispersed in water as first or second intervention followed by current PZQ formulation (Cysticide®) at 40 mg/kg with water as second or first intervention under fed condition. There was a wash-out period of at least 7 days between each of the intervention period.
51090|NCT02271984|O6|Outcome|Treatment E|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth without water under fed conditions in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51091|NCT02271984|O5|Outcome|Treatment D|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water in fasted condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51092|NCT02271984|O4|Outcome|Treatment C2|Subjects received a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51093|NCT02271984|O3|Outcome|Treatment C1|Subjects received a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51094|NCT02271984|O2|Outcome|Treatment B|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water, under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51095|NCT02271984|O1|Outcome|Treatment A|Subjects received a single oral dose of MSC2499550A formulation at 20 milligram per kilogram (mg/kg) dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each intervention period.
51096|NCT02271984|O6|Outcome|Treatment E|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth without water under fed conditions in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51097|NCT02271984|O5|Outcome|Treatment D|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water in fasted condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51098|NCT02271984|O4|Outcome|Treatment C2|Subjects received a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51275|NCT02270944|O1|Outcome|Liquid GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine
51099|NCT02271984|O3|Outcome|Treatment C1|Subjects received a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51100|NCT02271984|O2|Outcome|Treatment B|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water, under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51101|NCT02271984|O1|Outcome|Treatment A|Subjects received a single oral dose of MSC2499550A formulation at 20 milligram per kilogram (mg/kg) dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each intervention period.
51102|NCT02271984|O6|Outcome|Treatment E|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth without water under fed conditions in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51103|NCT02271984|O5|Outcome|Treatment D|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water in fasted condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51104|NCT02271984|O4|Outcome|Treatment C2|Subjects received a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51105|NCT02271984|O3|Outcome|Treatment C1|Subjects received a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51106|NCT02271984|O2|Outcome|Treatment B|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water, under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51107|NCT02271984|O1|Outcome|Treatment A|Subjects received a single oral dose of MSC2499550A formulation at 20 milligram per kilogram (mg/kg) dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each intervention period.
51108|NCT02271984|O6|Outcome|Treatment E|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth without water under fed conditions in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51109|NCT02271984|O5|Outcome|Treatment D|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water in fasted condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51110|NCT02271984|O4|Outcome|Treatment C2|Subjects received a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51111|NCT02271984|O3|Outcome|Treatment C1|Subjects received a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51112|NCT02271984|O2|Outcome|Treatment B|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water, under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51113|NCT02271984|O1|Outcome|Treatment A|Subjects received a single oral dose of MSC2499550A formulation at 20 milligram per kilogram (mg/kg) dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each intervention period.
51114|NCT02271984|O6|Outcome|Treatment E|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth without water under fed conditions in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51115|NCT02271984|O5|Outcome|Treatment D|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water in fasted condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51116|NCT02271984|O4|Outcome|Treatment C2|Subjects received a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51117|NCT02271984|O3|Outcome|Treatment C1|Subjects received a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51118|NCT02271984|O2|Outcome|Treatment B|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water, under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51119|NCT02271984|O1|Outcome|Treatment A|Subjects received a single oral dose of MSC2499550A formulation at 20 milligram per kilogram (mg/kg) dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each intervention period.
51120|NCT02271984|O6|Outcome|Treatment E|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth without water under fed conditions in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51121|NCT02271984|O5|Outcome|Treatment D|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water in fasted condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51122|NCT02271984|O4|Outcome|Treatment C2|Subjects received a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51123|NCT02271984|O3|Outcome|Treatment C1|Subjects received a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51124|NCT02271984|O2|Outcome|Treatment B|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water, under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51125|NCT02271984|O1|Outcome|Treatment A|Subjects received a single oral dose of MSC2499550A formulation at 20 milligram per kilogram (mg/kg) dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each intervention period.
51126|NCT02271984|O6|Outcome|Treatment E|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth without water under fed conditions in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51127|NCT02271984|O5|Outcome|Treatment D|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water in fasted condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51128|NCT02271984|O4|Outcome|Treatment C2|Subjects received a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51129|NCT02271984|O3|Outcome|Treatment C1|Subjects received a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51130|NCT02271984|O2|Outcome|Treatment B|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water, under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51131|NCT02271984|O1|Outcome|Treatment A|Subjects received a single oral dose of MSC2499550A formulation at 20 milligram per kilogram (mg/kg) dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each intervention period.
51132|NCT02271984|E6|Reported Event|Treatment E|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth without water under fed conditions in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51133|NCT02271984|E5|Reported Event|Treatment D|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water in fasted condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51134|NCT02271984|E4|Reported Event|Treatment C2|Subjects received a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51135|NCT02271984|E3|Reported Event|Treatment C1|Subjects received a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51136|NCT02271984|E2|Reported Event|Treatment B|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water, under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
51137|NCT02271984|E1|Reported Event|Treatment A|Subjects received a single oral dose of MSC2499550A formulation at 20 milligram per kilogram (mg/kg) dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each intervention period.
51138|NCT02271945|B3|Baseline|TOTAL|Total of all reporting groups
51139|NCT02271945|B2|Baseline|MEDI-551 12 mg/kg and MEDI0680 10 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51140|NCT02271945|B1|Baseline|MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51141|NCT02271945|P2|Participant Flow|MEDI-551 12 mg/kg and MEDI0680 10 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51142|NCT02271945|P1|Participant Flow|MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51143|NCT02271945|O2|Outcome|MEDI-551 12 mg/kg and MEDI0680 10 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51144|NCT02271945|O1|Outcome|MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51145|NCT02271945|O2|Outcome|MEDI-551 12 mg/kg and MEDI0680 10 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51146|NCT02271945|O1|Outcome|MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51147|NCT02271945|O2|Outcome|MEDI-551 12 mg/kg and MEDI0680 10 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51276|NCT02270944|E2|Reported Event|Lyophilized GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
51148|NCT02271945|O1|Outcome|MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51149|NCT02271945|O2|Outcome|MEDI-551 12 mg/kg and MEDI0680 10 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51150|NCT02271945|O1|Outcome|MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51151|NCT02271945|O2|Outcome|MEDI-551 12 mg/kg and MEDI0680 10 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51152|NCT02271945|O1|Outcome|MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51153|NCT02271945|O2|Outcome|MEDI-551 12 mg/kg and MEDI0680 10 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51154|NCT02271945|O1|Outcome|MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51155|NCT02271945|O2|Outcome|MEDI-551 12 mg/kg and MEDI0680 10 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51156|NCT02271945|O1|Outcome|MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51157|NCT02271945|O2|Outcome|MEDI-551 12 mg/kg and MEDI0680 10 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51158|NCT02271945|O1|Outcome|MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51159|NCT02271945|O2|Outcome|MEDI-551 12 mg/kg and MEDI0680 10 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51160|NCT02271945|O1|Outcome|MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51161|NCT02271945|O2|Outcome|MEDI-551 12 mg/kg and MEDI0680 10 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51162|NCT02271945|O1|Outcome|MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51163|NCT02271945|O2|Outcome|MEDI-551 12 mg/kg and MEDI0680 10 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51164|NCT02271945|O1|Outcome|MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51165|NCT02271945|O2|Outcome|MEDI-551 12 mg/kg and MEDI0680 10 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51166|NCT02271945|O1|Outcome|MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51167|NCT02271945|O2|Outcome|MEDI-551 12 mg/kg and MEDI0680 10 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51168|NCT02271945|O1|Outcome|MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51169|NCT02271945|O2|Outcome|MEDI-551 12 mg/kg and MEDI0680 10 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51277|NCT02270944|E1|Reported Event|Liquid GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine
51278|NCT02270684|B3|Baseline|Total|Total of all reporting groups
51170|NCT02271945|O1|Outcome|MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51171|NCT02271945|O2|Outcome|MEDI-551 12 mg/kg and MEDI0680 10 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51172|NCT02271945|O1|Outcome|MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51173|NCT02271945|O2|Outcome|MEDI-551 12 mg/kg and MEDI0680 10 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51174|NCT02271945|O1|Outcome|MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51175|NCT02271945|E2|Reported Event|MEDI-551 12 mg/kg and MEDI0680 10 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51176|NCT02271945|E1|Reported Event|MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
51177|NCT02271880|B3|Baseline|Total|Total of all reporting groups
51178|NCT02271880|B2|Baseline|Medication as Usual + STAR|"Medication as typically prescribed with the addition of the psychosocial intervention to improve medication adherence~Medication as usual + STAR: Physicians will prescribe medication and adolescents and their parents will receive 6 sessions of psychosocial treatment to improve adolescents' motivation to use medication and to develop parent/teen contracting with the goal of setting medication adherence goals."
51179|NCT02271880|B1|Baseline|Medication as Usual|"Medication as typically prescribed by physician.~Medication as usual: Physicians will prescribe medication as usual to the adolescent."
51180|NCT02271880|P2|Participant Flow|Medication as Usual + STAR|"Medication as typically prescribed with the addition of the psychosocial intervention to improve medication adherence~Medication as usual + STAR (Supporting Teen Adherence and Responsibility): Physicians will prescribe medication and adolescents and their parents will receive 6 sessions of psychosocial treatment to improve adolescents' motivation to use medication and to develop parent/teen contracting with the goal of setting medication adherence goals."
51181|NCT02271880|P1|Participant Flow|Medication as Usual|"Medication as typically prescribed by physician.~Medication as usual: Physicians will prescribe medication as usual to the adolescent."
51182|NCT02271880|O2|Outcome|Medication as Usual + STAR|"Medication as typically prescribed with the addition of the psychosocial intervention to improve medication adherence~Medication as usual + STAR: Physicians will prescribe medication and adolescents and their parents will receive 6 sessions of psychosocial treatment to improve adolescents' motivation to use medication and to develop parent/teen contracting with the goal of setting medication adherence goals."
51183|NCT02271880|O1|Outcome|Medication as Usual|"Medication as typically prescribed by physician.~Medication as usual: Physicians will prescribe medication as usual to the adolescent."
51184|NCT02271880|E2|Reported Event|Medication as Usual + STAR|"Medication as typically prescribed with the addition of the psychosocial intervention to improve medication adherence~Medication as usual + STAR: Physicians will prescribe medication and adolescents and their parents will receive 6 sessions of psychosocial treatment to improve adolescents' motivation to use medication and to develop parent/teen contracting with the goal of setting medication adherence goals."
51185|NCT02271880|E1|Reported Event|Medication as Usual|"Medication as typically prescribed by physician.~Medication as usual: Physicians will prescribe medication as usual to the adolescent."
51186|NCT02271854|B1|Baseline|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1% applied four times daily~Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
51187|NCT02271854|P1|Participant Flow|Diclofenac Sodium Gel 1% and Placebo Gel|This study is a within-subject design i.e. diclofenac sodium gel 1% four times a day applied to one leg and placebo gel four times a day applied to the other leg to the other leg at the same time
51188|NCT02271854|O2|Outcome|Placebo|"Placebo gel applied four times daily~Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
51189|NCT02271854|O1|Outcome|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1% applied four times daily~Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
51190|NCT02271854|O2|Outcome|Placebo|"Placebo gel applied four times daily~Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
51191|NCT02271854|O1|Outcome|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1% applied four times daily~Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
51192|NCT02271854|E1|Reported Event|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1% applied four times daily~Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
51193|NCT02271698|B5|Baseline|Total|Total of all reporting groups
51194|NCT02271698|B4|Baseline|Placebo|"Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision."
51195|NCT02271698|B3|Baseline|Dexamethasone 24mg|"Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
53719|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
51196|NCT02271698|B2|Baseline|Dexamethasone 12mg|"Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
51197|NCT02271698|B1|Baseline|Dexamethasone 6mg|"Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
51198|NCT02271698|P4|Participant Flow|Placebo|"Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision."
51199|NCT02271698|P3|Participant Flow|Dexamethasone 24mg|"Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
51200|NCT02271698|P2|Participant Flow|Dexamethasone 12mg|"Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
51201|NCT02271698|P1|Participant Flow|Dexamethasone 6mg|"Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
51202|NCT02271698|O4|Outcome|Placebo|"Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision."
51203|NCT02271698|O3|Outcome|Dexamethasone 24mg|"Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
51204|NCT02271698|O2|Outcome|Dexamethasone 12mg|"Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
51205|NCT02271698|O1|Outcome|Dexamethasone 6mg|"Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
51206|NCT02271698|O4|Outcome|Placebo|"Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision."
51207|NCT02271698|O3|Outcome|Dexamethasone 24mg|"Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
51208|NCT02271698|O2|Outcome|Dexamethasone 12mg|"Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
51209|NCT02271698|O1|Outcome|Dexamethasone 6mg|"Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
51210|NCT02271698|O4|Outcome|Placebo|"Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision."
51211|NCT02271698|O3|Outcome|Dexamethasone 24mg|"Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
51212|NCT02271698|O2|Outcome|Dexamethasone 12mg|"Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
51213|NCT02271698|O1|Outcome|Dexamethasone 6mg|"Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
51214|NCT02271698|O4|Outcome|Placebo|"Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision."
51215|NCT02271698|O3|Outcome|Dexamethasone 24mg|"Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
51216|NCT02271698|O2|Outcome|Dexamethasone 12mg|"Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
51217|NCT02271698|O1|Outcome|Dexamethasone 6mg|"Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
51218|NCT02271698|O4|Outcome|Placebo|"Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision."
51219|NCT02271698|O3|Outcome|Dexamethasone 24mg|"Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
51220|NCT02271698|O2|Outcome|Dexamethasone 12mg|"Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
51221|NCT02271698|O1|Outcome|Dexamethasone 6mg|"Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
51222|NCT02271698|E4|Reported Event|Placebo|"Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision."
51223|NCT02271698|E3|Reported Event|Dexamethasone 24mg|"Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
51224|NCT02271698|E2|Reported Event|Dexamethasone 12mg|"Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
51225|NCT02271698|E1|Reported Event|Dexamethasone 6mg|"Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
51226|NCT02271529|B1|Baseline|Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent|Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
51227|NCT02271529|P1|Participant Flow|Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent|Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
51228|NCT02271529|O1|Outcome|Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent|Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
51229|NCT02271529|E1|Reported Event|Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent|Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
51230|NCT02271477|B3|Baseline|Total|Total of all reporting groups
51231|NCT02271477|B2|Baseline|Echocardiography|In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation. After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid).
51232|NCT02271477|B1|Baseline|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
51279|NCT02270684|B2|Baseline|Usual and Customary Care|Participants in this arm will undergo usual care and will not be issued with the StepRite device
51233|NCT02271477|P2|Participant Flow|Echocardiography|"In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation.~After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid). After this repletion, patient is analyzed till the exam reach signal of non-responsiveness, previously defined as a reduction of Inferior Vena Cava diameter less than 36%"
51234|NCT02271477|P1|Participant Flow|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
51235|NCT02271477|O2|Outcome|Echocardiography|"In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation.~Ultrasound-guided volemic repletion: After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid). After this repletion, patient is analyzed till the exam reach signal of non-responsiveness"
51236|NCT02271477|O1|Outcome|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
51237|NCT02271477|O2|Outcome|Echocardiography|In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation. After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid).
51238|NCT02271477|O1|Outcome|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
51239|NCT02271477|O2|Outcome|Echocardiography|"In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation.~Ultrasound-guided volemic repletion: After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid). After this repletion, patient is analyzed till the exam reach signal of non-responsiveness"
51240|NCT02271477|O1|Outcome|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
51241|NCT02271477|O2|Outcome|Echocardiography|In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation. After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid).
51242|NCT02271477|O1|Outcome|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
83997|NCT02061358|B4|Baseline|90 mg UV-4B|UV-4B 90 mg oral, single dose
51243|NCT02271477|E2|Reported Event|Echocardiography|In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation. Ultrasound-guided volemic repletion: After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid).
51244|NCT02271477|E1|Reported Event|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
51245|NCT02271217|B4|Baseline|Total|Total of all reporting groups
51246|NCT02271217|B3|Baseline|Dalfampridine-ER 10mg|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~dalfampridine-ER 10mg"
51247|NCT02271217|B2|Baseline|Dalfampridine-ER 7.5 mg|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~dalfampridine-ER 7.5mg"
51248|NCT02271217|B1|Baseline|Placebo|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~Placebo"
51249|NCT02271217|P3|Participant Flow|Dalfampridine-ER 10mg|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~dalfampridine-ER 10mg"
51250|NCT02271217|P2|Participant Flow|Dalfampridine-ER 7.5 mg|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~dalfampridine-ER 7.5mg"
51251|NCT02271217|P1|Participant Flow|Placebo|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~Placebo"
51252|NCT02271217|O3|Outcome|Dalfampridine-ER 10mg|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~dalfampridine-ER 10mg"
51253|NCT02271217|O2|Outcome|Dalfampridine-ER 7.5 mg|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~dalfampridine-ER 7.5mg"
51254|NCT02271217|O1|Outcome|Placebo|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~Placebo"
51255|NCT02271217|O3|Outcome|Dalfampridine-ER 10mg|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~dalfampridine-ER 10mg"
51256|NCT02271217|O2|Outcome|Dalfampridine-ER 7.5 mg|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~dalfampridine-ER 7.5mg"
51257|NCT02271217|O1|Outcome|Placebo|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~Placebo"
51258|NCT02271217|E3|Reported Event|Dalfampridine-ER 10mg|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~dalfampridine-ER 10mg"
51259|NCT02271217|E2|Reported Event|Dalfampridine-ER 7.5 mg|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~dalfampridine-ER 7.5mg"
51260|NCT02271217|E1|Reported Event|Placebo|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~Placebo"
51261|NCT02270944|B3|Baseline|Total|Total of all reporting groups
51262|NCT02270944|B2|Baseline|Lyophilized GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
51263|NCT02270944|B1|Baseline|Liquid GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine
51264|NCT02270944|P2|Participant Flow|Lyophilized GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
51265|NCT02270944|P1|Participant Flow|Liquid GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine
51266|NCT02270944|O2|Outcome|Lyophilized GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
51267|NCT02270944|O1|Outcome|Liquid GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine
51268|NCT02270944|O2|Outcome|Lyophilized GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
51269|NCT02270944|O1|Outcome|Liquid GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine
51270|NCT02270944|O2|Outcome|Lyophilized GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
51271|NCT02270944|O1|Outcome|Liquid GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine.
51272|NCT02270944|O2|Outcome|Lyophilized GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
51273|NCT02270944|O1|Outcome|Liquid GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine
51274|NCT02270944|O2|Outcome|Lyophilized GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
51280|NCT02270684|B1|Baseline|Device|"Participants in this arm will receive the StepRite device. They will have a remote visit with their Physical Therapist in place of one in-person visit per week during the outpatient phase of their treatment~StepRite: The StepRite device uses an insole to monitor motion, and relays this information to the physical therapist via a smart phone app and web link. Set exercises can be programmed into the app for the participant to complete"
51281|NCT02270684|P2|Participant Flow|Usual and Customary Care|Participants in this arm will undergo usual care and will not be issued with the StepRite device
51282|NCT02270684|P1|Participant Flow|Device|"Participants in this arm will receive the StepRite device. They will have a remote visit with their Physical Therapist in place of one in-person visit per week during the outpatient phase of their treatment~StepRite: The StepRite device uses an insole to monitor motion, and relays this information to the physical therapist via a smart phone app and web link. Set exercises can be programmed into the app for the participant to complete"
51283|NCT02270684|O2|Outcome|Usual and Customary Care|Participants in this arm will undergo usual care and will not be issued with the StepRite device
51284|NCT02270684|O1|Outcome|Device|"Participants in this arm will receive the StepRite device. They will have a remote visit with their Physical Therapist in place of one in-person visit per week during the outpatient phase of their treatment~StepRite: The StepRite device uses an insole to monitor motion, and relays this information to the physical therapist via a smart phone app and web link. Set exercises can be programmed into the app for the participant to complete"
51285|NCT02270684|E2|Reported Event|Usual and Customary Care|Participants in this arm will undergo usual care and will not be issued with the StepRite device
51286|NCT02270684|E1|Reported Event|Device|"Participants in this arm will receive the StepRite device. They will have a remote visit with their Physical Therapist in place of one in-person visit per week during the outpatient phase of their treatment~StepRite: The StepRite device uses an insole to monitor motion, and relays this information to the physical therapist via a smart phone app and web link. Set exercises can be programmed into the app for the participant to complete"
51287|NCT02270515|B1|Baseline|PCMH-KD Dialysis Care|Enrolled patients had access to an expanded care team inlcuding a primary care doctor, nurse coordinator, community health worker, and pharmacist.
51288|NCT02270515|P1|Participant Flow|PCMH-KD Dialysis Care|"Dialysis care team is expanded to include a primary care doctor, nurse coordinator, community health worker, and a pharmacist.~Patient-Centered Medical Home for Kidney Disease (PCMH-KD): A PCMH-KD enhances the usual dialysis care team by adding a primary care doctor, pharmacist, nurse coordinator and community health worker to the care team."
51289|NCT02270515|O4|Outcome|Change 0-18 Months|Change of mean score from Baseline (0) to 18 months
51290|NCT02270515|O3|Outcome|Change 12-18 Months|Change of mean score from 12 months to 18 months
51291|NCT02270515|O2|Outcome|Change 6-12 Months|Change of mean score from 6 months to 12 months
51292|NCT02270515|O1|Outcome|Change 0-6 Months|Change of mean score from Baseline (0) to 6 months
51293|NCT02270515|O4|Outcome|18 Months|KDQOL collected at 18 months
51294|NCT02270515|O3|Outcome|12 Months|KDQOL collected at 12 months
51295|NCT02270515|O2|Outcome|6 Months|KDQOL collected at 6 months
51296|NCT02270515|O1|Outcome|Baseline|KDQOL collected at Baseline
51297|NCT02270515|O4|Outcome|18 Months|KDQOL collected at 18 months
51298|NCT02270515|O3|Outcome|12 Months|KDQOL collected at 12 months
51299|NCT02270515|O2|Outcome|6 Months|KDQOL collected at 6 months
51300|NCT02270515|O1|Outcome|Baseline|KDQOL collected at Baseline
51301|NCT02270515|E1|Reported Event|PCMH-KD Dialysis Care|"Dialysis care team is expanded to include a primary care doctor, nurse coordinator, community health worker, and pharmacist.~Patient-Centered Medical Home for Kidney Disease (PCMH-KD): A PCMH-KD enhances the usual dialysis care team by adding a primary care doctor, pharmacist, nurse coordinator and community health worker to the care team."
51302|NCT02269709|B1|Baseline|ARFI Ultrasound|Subjects were pediatric patients who had undergone a Fontan operation. Subjects underwent an ultrasound before and after the Fontan operation. The ultrasound scan used acoustic radiation force impulse (ARFI) shear wave velocity imaging (SVI). This is a non-invasive scan that uses sound waves to create images of the liver and measure the stiffness of the tissue.
51303|NCT02269709|P1|Participant Flow|ARFI Ultrasound|"Subjects were pediatric patients who had undergone a repair of a heart defect, called a Fontan operation. Patients underwent an ultrasound before and after the Fontan operation.~The ultrasound scan used acoustic radiation force impulse (ARFI) shear wave velocity imaging (SVI). This is a non-invasive scan that uses sound waves to create images of the liver and measure its stiffness."
51304|NCT02269709|O1|Outcome|ARFI Ultrasound|Subjects underwent an ultrasound scan before and after the Fontan operation. The blood pressure in the IVC (interior vena cava) was measured.
51305|NCT02269709|O1|Outcome|ARFI Ultrasound|Subjects underwent an ultrasound scan before and after the Fontan operation.
51306|NCT02269709|E1|Reported Event|ARFI Ultrasound|Subjects underwent an ultrasound scan before and after the Fontan operation.
51307|NCT02269657|B1|Baseline|Subject Cohort|Two bi-planar full spinal X-rays were taken using the EOS® imaging system with subjects standing in two different positions. The first x-ray was taken while the subject's hands and forearms in front of them on the wall vertically. A second image was taken while the subject's knuckles loosely placed on ipsi-lateral clavicles. A pressure mat recorded the magnitude of pressure under the subjects' feet during each set of images.
51308|NCT02269657|P1|Participant Flow|Subject Cohort|Two bi-planar full spinal X-ray were taken using the EOS® imaging system with subjects standing in two different positions. The first x-ray was taken while the subject's hands and forearms in front of them on the wall vertically. A second image was taken while the subject's knuckles loosely placed on ipsi-lateral clavicles. A pressure mat recorded the magnitude of pressure under the subjects' feet during each set of images.
51309|NCT02269657|O3|Outcome|Natural Standing Position|Subjects stood with their arms hanging on either side. Images were not taken but a pressure mat recording of the position of the arm center of pressure during this arm position was recorded.
51310|NCT02269657|O2|Outcome|Clavicle Position|Subjects stood with a 45 degree shoulder flexion with their knuckles on their clavicles. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
51311|NCT02269657|O1|Outcome|Wall Position|Subjects stood with a 90 degree shoulder and elbow flexion with forearms and palms on the wall in front of them. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
51312|NCT02269657|O2|Outcome|Clavicle Position|Subjects stood with a 45 degree shoulder flexion with their knuckles on their clavicles. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
51313|NCT02269657|O1|Outcome|Wall Position|Subjects stood with a 90 degree shoulder and elbow flexion with forearms and palms on the wall in front of them. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
51314|NCT02269657|O2|Outcome|Clavicle Position|Subjects stood with a 45 degree shoulder flexion with their knuckles on their clavicles. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
51315|NCT02269657|O1|Outcome|Wall Position|Subjects stood with a 90 degree shoulder and elbow flexion with forearms and palms on the wall in front of them. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
51316|NCT02269657|O2|Outcome|Clavicle Position|Subjects stood with a 45 degree shoulder flexion with their knuckles on their clavicles. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
51317|NCT02269657|O1|Outcome|Wall Position|Subjects stood with a 90 degree shoulder and elbow flexion with forearms and palms on the wall in front of them. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
51318|NCT02269657|O2|Outcome|Clavicle Position|Subjects stood with a 45 degree shoulder flexion with their knuckles on their clavicles. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
51319|NCT02269657|O1|Outcome|Wall Position|Subjects stood with a 90 degree shoulder and elbow flexion with forearms and palms on the wall in front of them. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
51320|NCT02269657|E1|Reported Event|Subject Cohort|Two bi-planar full spinal X-ray were taken using the EOS® imaging system with subjects standing in two different positions. The first x-ray was taken while the subject's hands and forearms in front of them on the wall vertically. A second image was taken while the subject's knuckles loosely placed on ipsi-lateral clavicles. A pressure mat recorded the magnitude of pressure under the subjects' feet during each set of images.
51321|NCT02269488|B1|Baseline|MEDI3250|MEDI3250 was administered to all subjects.
51322|NCT02269488|P1|Participant Flow|MEDI3250|MEDI3250 was administered to all subjects.
51323|NCT02269488|O1|Outcome|MEDI3250|MEDI3250 was administered to all subjects.
51324|NCT02269488|E1|Reported Event|MEDI3250|MEDI3250 was administered to all subjects.
51325|NCT02269475|B3|Baseline|Total|Total of all reporting groups
51326|NCT02269475|B2|Baseline|Placebo|Placebo, 0.2mL as nasal spray
51327|NCT02269475|B1|Baseline|MEDI3250|MEDI3250, 0.2mL as nasal spray
51328|NCT02269475|P2|Participant Flow|Placebo|Placebo, 0.2mL as nasal spray
51329|NCT02269475|P1|Participant Flow|MEDI3250|MEDI3250, 0.2mL as nasal spray
51330|NCT02269475|O2|Outcome|Placebo|Placebo, 0.2mL as nasal spray
51331|NCT02269475|O1|Outcome|MEDI3250|MEDI3250, 0.2mL as nasal spray
51332|NCT02269475|O2|Outcome|Placebo|Placebo, 0.2mL as nasal spray
51333|NCT02269475|O1|Outcome|MEDI3250|MEDI3250, 0.2mL as nasal spray
51334|NCT02269475|O2|Outcome|Placebo|Placebo, 0.2mL as nasal spray
51335|NCT02269475|O1|Outcome|MEDI3250|MEDI3250, 0.2mL as nasal spray
51336|NCT02269475|E3|Reported Event|Total Number|
51337|NCT02269475|E2|Reported Event|Placebo|Placebo, 0.2mL as nasal spray
51338|NCT02269475|E1|Reported Event|MEDI3250|MEDI3250, 0.2mL as nasal spray
51339|NCT02269098|B3|Baseline|Total|Total of all reporting groups
51340|NCT02269098|B2|Baseline|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
51341|NCT02269098|B1|Baseline|Intervention|"Diabetes survival skills self-management education (G meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED. ; plus diabetes medication management using medication algorithm ( Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.~Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
51458|NCT02268214|O3|Outcome|Placebo + Insulin|Placebo oral tablet once daily for 24 weeks + background insulin
51342|NCT02269098|P2|Participant Flow|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
51343|NCT02269098|P1|Participant Flow|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.~.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
51344|NCT02269098|O2|Outcome|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
51345|NCT02269098|O1|Outcome|Intervention|"Diabetes survival skills self-management education; plus diabetes medication management using medication algorithm by diabetes educator supervised by endocrinologist, plus health system naviagation.~Metformin, sulfonylureas and basal insulin were included in the algorithm. Survival skills DSME included: BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.~Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Navigation included securing a primary care"
51346|NCT02269098|O2|Outcome|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
51347|NCT02269098|O1|Outcome|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.~.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
51348|NCT02269098|O2|Outcome|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
51349|NCT02269098|O1|Outcome|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.~.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
51350|NCT02269098|O2|Outcome|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
51351|NCT02269098|O1|Outcome|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.~.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
51459|NCT02268214|O2|Outcome|Dapagliflozin 10 mg + Insulin|Dapagliflozin 10 mg oral tablet once daily for 24 weeks + background insulin
83998|NCT02061358|B3|Baseline|30 mg UV-4B|UV-4B 30 mg oral, single dose
51352|NCT02269098|O2|Outcome|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
51353|NCT02269098|O1|Outcome|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.~.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
51354|NCT02269098|E2|Reported Event|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
51355|NCT02269098|E1|Reported Event|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.~.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
51356|NCT02268994|B3|Baseline|Total|Total of all reporting groups
51357|NCT02268994|B2|Baseline|Placebo|"Matching Placebo~Placebo: Matching placebo"
51358|NCT02268994|B1|Baseline|KRX-0502 (Ferric Citrate)|"1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron~ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron"
51359|NCT02268994|P2|Participant Flow|Placebo|"Matching Placebo~Placebo: Matching placebo"
51360|NCT02268994|P1|Participant Flow|KRX-0502 (Ferric Citrate)|"1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron~ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron"
51361|NCT02268994|O2|Outcome|Placebo|"Matching Placebo~Placebo: Matching placebo"
51362|NCT02268994|O1|Outcome|KRX-0502 (Ferric Citrate)|"1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron~ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron"
51363|NCT02268994|O2|Outcome|Placebo|"Matching Placebo~Placebo: Matching placebo"
51364|NCT02268994|O1|Outcome|KRX-0502 (Ferric Citrate)|"1 g KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron~ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron"
51365|NCT02268994|O2|Outcome|Placebo|"Matching Placebo~Placebo: Matching placebo"
51366|NCT02268994|O1|Outcome|KRX-0502 (Ferric Citrate)|"1 gr of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron~ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron"
51367|NCT02268994|O2|Outcome|Placebo|"Matching Placebo~Placebo: Matching placebo"
51368|NCT02268994|O1|Outcome|KRX-0502 (Ferric Citrate)|"1 g KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron~ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron"
51369|NCT02268994|O2|Outcome|Placebo|"Matching Placebo~Placebo: Matching placebo"
51370|NCT02268994|O1|Outcome|KRX-0502 (Ferric Citrate)|"1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron~ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron"
51371|NCT02268994|O2|Outcome|Placebo|"Matching Placebo~Placebo: Matching placebo"
51372|NCT02268994|O1|Outcome|KRX-0502 (Ferric Citrate)|"1 g KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron~ferric citrate: 1 gr ferric citrate containing approximately 210 mg of ferric iron"
51373|NCT02268994|E2|Reported Event|Placebo|"Matching Placebo~Placebo: Matching placebo"
51374|NCT02268994|E1|Reported Event|KRX-0502 (Ferric Citrate)|"1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron~ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron"
51375|NCT02268877|B3|Baseline|Total|Total of all reporting groups
51376|NCT02268877|B2|Baseline|Radiology Tech Ultrasound|"Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care.~Ultrasound: An ultrasound will be performed by a radiology department technician"
51377|NCT02268877|B1|Baseline|Emergency Medicine Physician Ultrasound|"Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound.~Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician~Ultrasound: An ultrasound will be performed by a radiology department technician"
51378|NCT02268877|P2|Participant Flow|Radiology Tech Ultrasound|"Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care.~Ultrasound: An ultrasound will be performed by a radiology department technician"
51403|NCT02268864|O2|Outcome|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
51379|NCT02268877|P1|Participant Flow|Emergency Medicine Physician Ultrasound|"Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound.~Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician~Ultrasound: An ultrasound will be performed by a radiology department technician"
51380|NCT02268877|O2|Outcome|Radiology Tech Ultrasound|"Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care.~Ultrasound: An ultrasound will be performed by a radiology department technician"
51381|NCT02268877|O1|Outcome|Emergency Medicine Physician Ultrasound|"Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound.~Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician~Ultrasound: An ultrasound will be performed by a radiology department technician"
51382|NCT02268877|O2|Outcome|Radiology Tech Ultrasound|"Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care.~Ultrasound: An ultrasound will be performed by a radiology department technician"
51383|NCT02268877|O1|Outcome|Emergency Medicine Physician Ultrasound|"Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound.~Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician~Ultrasound: An ultrasound will be performed by a radiology department technician"
51384|NCT02268877|E2|Reported Event|Radiology Tech Ultrasound|"Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care.~Ultrasound: An ultrasound will be performed by a radiology department technician"
51385|NCT02268877|E1|Reported Event|Emergency Medicine Physician Ultrasound|"Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound.~Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician~Ultrasound: An ultrasound will be performed by a radiology department technician"
51386|NCT02268864|B4|Baseline|Total|Total of all reporting groups
51387|NCT02268864|B3|Baseline|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
51388|NCT02268864|B2|Baseline|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
51389|NCT02268864|B1|Baseline|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
51390|NCT02268864|P3|Participant Flow|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
51391|NCT02268864|P2|Participant Flow|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
51392|NCT02268864|P1|Participant Flow|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
51393|NCT02268864|O3|Outcome|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24 week treatment after amendment.
51394|NCT02268864|O2|Outcome|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12 week treatment period after amendment.
51395|NCT02268864|O1|Outcome|12 Weeks Prior Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12 week treatment before Amendment 3 of the protocol was implemented.
51396|NCT02268864|O3|Outcome|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24 week treatment after amendment.
51397|NCT02268864|O2|Outcome|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12 week treatment period after amendment.
51398|NCT02268864|O1|Outcome|12 Weeks Prior Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12 week treatment before Amendment 3 of the protocol was implemented.
51399|NCT02268864|O3|Outcome|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
51400|NCT02268864|O2|Outcome|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
51401|NCT02268864|O1|Outcome|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
51402|NCT02268864|O3|Outcome|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
53720|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
51404|NCT02268864|O1|Outcome|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
51405|NCT02268864|O3|Outcome|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
51406|NCT02268864|O2|Outcome|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
51407|NCT02268864|O1|Outcome|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
51408|NCT02268864|O3|Outcome|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
51409|NCT02268864|O2|Outcome|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
51410|NCT02268864|O1|Outcome|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
51411|NCT02268864|E2|Reported Event|12-24 Weeks|Simeprevir 150 mg once daily as an oral capsule in combination with Daclatasvir 60 mg once daily as an oral tablet for participants who has AEs that started after day 88 on treatment.
51412|NCT02268864|E1|Reported Event|1-12 Weeks|Simeprevir 150 mg once daily as an oral capsule in combination with Daclatasvir 60 mg once daily as an oral tablet for participants who has adverse events (AEs) that started before or on day 88 on treatment.
51413|NCT02268526|B4|Baseline|Total|Total of all reporting groups
51414|NCT02268526|B3|Baseline|Cohort 2: Placebo|Cohort 2: Placebo IV q 4weeks
51415|NCT02268526|B2|Baseline|Cohort 2: CSJ148|Cohort 2: CSJ148 IV q 4weeks
51416|NCT02268526|B1|Baseline|Cohort 1: CSJ148|Cohort 1: CSJ148 IV q 4weeks
51417|NCT02268526|P3|Participant Flow|Cohort 2: Placebo|Cohort 2: Placebo IV q 4weeks
51418|NCT02268526|P2|Participant Flow|Cohort 2: CSJ148|Cohort 2: CSJ148 IV q 4weeks
51419|NCT02268526|P1|Participant Flow|Cohort 1: CSJ148|Cohort 1: CSJ148 IV q 4weeks
51420|NCT02268526|O1|Outcome|Total CSJ148 (Cohort 1 & Cohort 2)|Cohort 1: CSJ148 IV q 4weeks and Cohort 2: CSJ148 IV q 4weeks
51421|NCT02268526|O1|Outcome|Total CSJ148 (Cohort 1 & Cohort 2)|Cohort 1: CSJ148 IV q 4weeks and Cohort 2: CSJ148 IV q 4weeks
51422|NCT02268526|O1|Outcome|Total CSJ148 (Cohort 1 & Cohort 2)|Cohort 1: CSJ148 IV q 4weeks and Cohort 2: CSJ148 IV q 4weeks
51423|NCT02268526|O1|Outcome|Total CSJ148 (Cohort 1 & Cohort 2)|Cohort 1: CSJ148 IV q 4weeks and Cohort 2: CSJ148 IV q 4weeks
51424|NCT02268526|O1|Outcome|Total CSJ148 (Cohort 1 & Cohort 2)|Cohort 1: CSJ148 IV q 4weeks and Cohort 2: CSJ148 IV q 4weeks
51425|NCT02268526|O1|Outcome|Total CSJ148 (Cohort 1 & Cohort 2)|Cohort 1: CSJ148 IV q 4weeks and Cohort 2: CSJ148 IV q 4weeks
51426|NCT02268526|O2|Outcome|Cohort 2: Placebo|Cohort 2: Placebo IV q 4weeks
51427|NCT02268526|O1|Outcome|Cohort 2: CSJ148|Cohort 2: CSJ148 IV q 4weeks
51428|NCT02268526|O2|Outcome|Cohort 2: Placebo|Cohort 2: Placebo IV q 4weeks
51429|NCT02268526|O1|Outcome|Cohort 2: CSJ148|Cohort 2: CSJ148 IV q 4weeks
51430|NCT02268526|O2|Outcome|Cohort 2: Placebo|Cohort 2: Placebo IV q 4weeks
51431|NCT02268526|O1|Outcome|Cohort 2: CSJ148|Cohort 2: CSJ148 IV q 4weeks
51432|NCT02268526|O2|Outcome|Cohort 2: Placebo|Cohort 2: Placebo IV q 4weeks
51433|NCT02268526|O1|Outcome|Total CSJ148 (Cohort 1 & Cohort 2)|Cohort 1: CSJ148 IV q 4weeks & Cohort 2: CSJ148 IV q 4 weeks
51434|NCT02268526|O3|Outcome|Cohort 2: Placebo|Cohort 2: Placebo IV q 4weeks
51435|NCT02268526|O2|Outcome|Cohort 2: CSJ148|Cohort 2: CSJ148 IV q 4weeks
51436|NCT02268526|O1|Outcome|Total CSJ148 (Cohort 1 & Cohort 2)|Cohort 1: CSJ148 IV q 4weeks and Cohort 2: CSJ148 IV q 4weeks
51437|NCT02268526|E2|Reported Event|Total CSJ148|Cohort 1: CSJ148 IV q 4weeks & Cohort 2: CSJ148 IV q 4weeks
51438|NCT02268526|E1|Reported Event|Placebo|Cohort 2: Placebo IV q 4weeks
51439|NCT02268396|B1|Baseline|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
51440|NCT02268396|P1|Participant Flow|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
51441|NCT02268396|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
51442|NCT02268396|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
51443|NCT02268396|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
51444|NCT02268396|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
51445|NCT02268396|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
51446|NCT02268396|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
51447|NCT02268396|E1|Reported Event|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
51448|NCT02268214|B4|Baseline|Total|Total of all reporting groups
51449|NCT02268214|B3|Baseline|Placebo + Insulin|Placebo oral tablet once daily for 24 weeks + background insulin
51450|NCT02268214|B2|Baseline|Dapagliflozin 10 mg + Insulin|Dapagliflozin 10 mg oral tablet once daily for 24 weeks + background insulin
51451|NCT02268214|B1|Baseline|Dapagliflozin 5 mg + Insulin|Dapagliflozin 5 mg oral tablet once daily for 24 weeks + background insulin
51452|NCT02268214|P3|Participant Flow|Placebo + Insulin|Placebo oral tablet once daily for 24 weeks + background insulin
51453|NCT02268214|P2|Participant Flow|Dapagliflozin 10 mg + Insulin|Dapagliflozin 10 mg oral tablet once daily for 24 weeks + background insulin
51454|NCT02268214|P1|Participant Flow|Dapagliflozin 5 mg + Insulin|Dapagliflozin 5 mg oral tablet once daily for 24 weeks + background insulin
51455|NCT02268214|O3|Outcome|Placebo + Insulin|Placebo oral tablet once daily for 24 weeks + background insulin
51456|NCT02268214|O2|Outcome|Dapagliflozin 10 mg + Insulin|Dapagliflozin 10 mg oral tablet once daily for 24 weeks + background insulin
83999|NCT02061358|B2|Baseline|10 mg UV-4B|UV-4B 10 mg oral, single dose
51460|NCT02268214|O1|Outcome|Dapagliflozin 5 mg + Insulin|Dapagliflozin 5 mg oral tablet once daily for 24 weeks + background insulin
51461|NCT02268214|O3|Outcome|Placebo + Insulin|Placebo oral tablet once daily for 24 weeks + background insulin
51462|NCT02268214|O2|Outcome|Dapagliflozin 10 mg + Insulin|Dapagliflozin 10 mg oral tablet once daily for 24 weeks + background insulin
51463|NCT02268214|O1|Outcome|Dapagliflozin 5 mg + Insulin|Dapagliflozin 5 mg oral tablet once daily for 24 weeks + background insulin
51464|NCT02268214|O3|Outcome|Placebo + Insulin|Placebo oral tablet once daily for 24 weeks + background insulin
51465|NCT02268214|O2|Outcome|Dapagliflozin 10 mg + Insulin|Dapagliflozin 10 mg oral tablet once daily for 24 weeks + background insulin
51466|NCT02268214|O1|Outcome|Dapagliflozin 5 mg + Insulin|Dapagliflozin 5 mg oral tablet once daily for 24 weeks + background insulin
51467|NCT02268214|O3|Outcome|Placebo + Insulin|Placebo oral tablet once daily for 24 weeks + background insulin
51468|NCT02268214|O2|Outcome|Dapagliflozin 10 mg + Insulin|Dapagliflozin 10 mg oral tablet once daily for 24 weeks + background insulin
51469|NCT02268214|O1|Outcome|Dapagliflozin 5 mg + Insulin|Dapagliflozin 5 mg oral tablet once daily for 24 weeks + background insulin
51470|NCT02268214|O3|Outcome|Placebo + Insulin|Placebo oral tablet once daily for 24 weeks + background insulin
51471|NCT02268214|O2|Outcome|Dapagliflozin 10 mg + Insulin|Dapagliflozin 10 mg oral tablet once daily for 24 weeks + background insulin
51472|NCT02268214|O1|Outcome|Dapagliflozin 5 mg + Insulin|Dapagliflozin 5 mg oral tablet once daily for 24 weeks + background insulin
51473|NCT02268214|O3|Outcome|Placebo + Insulin|Placebo oral tablet once daily for 24 weeks + background insulin
51474|NCT02268214|O2|Outcome|Dapagliflozin 10 mg + Insulin|Dapagliflozin 10 mg oral tablet once daily for 24 weeks + background insulin
51475|NCT02268214|O1|Outcome|Dapagliflozin 5 mg + Insulin|Dapagliflozin 5 mg oral tablet once daily for 24 weeks + background insulin
51476|NCT02268214|E3|Reported Event|Placebo + Insulin|Placebo oral tablet once daily for 24 weeks + background insulin
51477|NCT02268214|E2|Reported Event|Dapagliflozin 10 mg + Insulin|Dapagliflozin 10 mg oral tablet once daily for 24 weeks + background insulin
51478|NCT02268214|E1|Reported Event|Dapagliflozin 5 mg + Insulin|Dapagliflozin 5 mg oral tablet once daily for 24 weeks + background insulin
51479|NCT02268058|B5|Baseline|Total|Total of all reporting groups
51480|NCT02268058|B4|Baseline|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.~The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
51481|NCT02268058|B3|Baseline|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency Department.~Acetaminophen: routine administration of medication for a 72 hour period~Ibuprofen: routine administration of medication for a 72 hour period"
51482|NCT02268058|B2|Baseline|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Ibuprofen: routine administration of medication for a 72 hour period"
51483|NCT02268058|B1|Baseline|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Acetaminophen: routine administration of medication for a 72 hour period"
51484|NCT02268058|P4|Participant Flow|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.~The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
51485|NCT02268058|P3|Participant Flow|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency Department.~Acetaminophen: routine administration of medication for a 72 hour period~Ibuprofen: routine administration of medication for a 72 hour period"
51486|NCT02268058|P2|Participant Flow|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Ibuprofen: routine administration of medication for a 72 hour period"
51487|NCT02268058|P1|Participant Flow|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Acetaminophen: routine administration of medication for a 72 hour period"
51488|NCT02268058|O4|Outcome|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.~The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
51489|NCT02268058|O3|Outcome|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency Department.~Acetaminophen: routine administration of medication for a 72 hour period~Ibuprofen: routine administration of medication for a 72 hour period"
51490|NCT02268058|O2|Outcome|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Ibuprofen: routine administration of medication for a 72 hour period"
51569|NCT02267447|O1|Outcome|Derivation Cohort|Eligible respondents to the combined 2001, 2003 and 2005 Canadian Community Health Surveys, conducted by Statistics Canada.
51570|NCT02267447|E2|Reported Event|Validation Cohort|Eligible respondents to the 2007/2008 Canadian Community Health Surveys.
51491|NCT02268058|O1|Outcome|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Acetaminophen: routine administration of medication for a 72 hour period"
51492|NCT02268058|O4|Outcome|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.~The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
51493|NCT02268058|O3|Outcome|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency Department.~Acetaminophen: routine administration of medication for a 72 hour period~Ibuprofen: routine administration of medication for a 72 hour period"
51494|NCT02268058|O2|Outcome|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Ibuprofen: routine administration of medication for a 72 hour period"
51495|NCT02268058|O1|Outcome|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Acetaminophen: routine administration of medication for a 72 hour period"
51496|NCT02268058|O4|Outcome|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.~The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
51497|NCT02268058|O3|Outcome|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency Department.~Acetaminophen: routine administration of medication for a 72 hour period~Ibuprofen: routine administration of medication for a 72 hour period"
51498|NCT02268058|O2|Outcome|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Ibuprofen: routine administration of medication for a 72 hour period"
51499|NCT02268058|O1|Outcome|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Acetaminophen: routine administration of medication for a 72 hour period"
51500|NCT02268058|O4|Outcome|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.~The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
51501|NCT02268058|O3|Outcome|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency Department.~Acetaminophen: routine administration of medication for a 72 hour period~Ibuprofen: routine administration of medication for a 72 hour period"
51502|NCT02268058|O2|Outcome|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Ibuprofen: routine administration of medication for a 72 hour period"
51503|NCT02268058|O1|Outcome|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Acetaminophen: routine administration of medication for a 72 hour period"
51504|NCT02268058|E4|Reported Event|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.~The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
51505|NCT02268058|E3|Reported Event|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency Department.~Acetaminophen: routine administration of medication for a 72 hour period~Ibuprofen: routine administration of medication for a 72 hour period"
51506|NCT02268058|E2|Reported Event|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Ibuprofen: routine administration of medication for a 72 hour period"
51507|NCT02268058|E1|Reported Event|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Acetaminophen: routine administration of medication for a 72 hour period"
51508|NCT02267850|B3|Baseline|Total|Total of all reporting groups
51509|NCT02267850|B2|Baseline|Sham-Control OrthoPulse™|"Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with carrying out daily non-functional OrthoPulse™ treatments (untreated control).~Fixed Orthodontic Appliance Treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~Non-Functional OrthoPulse™: Patients carry out daily sham-OrthoPulse™ treatments at home. This is a non-functional device so patients do not receive photobiomodulation therapy."
51713|NCT02266381|O3|Outcome|Combined-guided Group|Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
51510|NCT02267850|B1|Baseline|OrthoPulse™|"Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.~Fixed Orthodontic Appliance Treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
51511|NCT02267850|P2|Participant Flow|Sham-Control OrthoPulse™|"Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with carrying out daily non-functional OrthoPulse™ treatments (untreated control).~Fixed Orthodontic Appliance Treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~Non-Functional OrthoPulse™: Patients carry out daily sham-OrthoPulse™ treatments at home. This is a non-functional device so patients do not receive photobiomodulation therapy."
51512|NCT02267850|P1|Participant Flow|OrthoPulse™|"Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.~Fixed Orthodontic Appliance Treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
51513|NCT02267850|O2|Outcome|Sham-Control OrthoPulse™|"Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with carrying out daily non-functional OrthoPulse™ treatments (untreated control).~Fixed Orthodontic Appliance Treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~Non-Functional OrthoPulse™: Patients carry out daily sham-OrthoPulse™ treatments at home. This is a non-functional device so patients do not receive photobiomodulation therapy."
51514|NCT02267850|O1|Outcome|OrthoPulse™|"Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.~Fixed Orthodontic Appliance Treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
51515|NCT02267850|E2|Reported Event|Sham-Control OrthoPulse™|"Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with carrying out daily non-functional OrthoPulse™ treatments (untreated control).~Fixed Orthodontic Appliance Treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~Non-Functional OrthoPulse™: Patients carry out daily sham-OrthoPulse™ treatments at home. This is a non-functional device so patients do not receive photobiomodulation therapy."
51516|NCT02267850|E1|Reported Event|OrthoPulse™|"Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.~Fixed Orthodontic Appliance Treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
51517|NCT02267837|B3|Baseline|Total|Total of all reporting groups
51518|NCT02267837|B2|Baseline|Control|Subjects assigned to this group receive only full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI), and no OrthoPulse™ treatments. Treatment and follow-up appointments per the traditional practices of the PI and dental office.
51519|NCT02267837|B1|Baseline|OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI), in conjunction with receiving daily OrthoPulse™ treatments. Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
51520|NCT02267837|P2|Participant Flow|No OrthoPulse™|"Subjects assigned to this group receive fixed orthodontic appliance treatment only, and no OrthoPulse™ treatments.~Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office."
51521|NCT02267837|P1|Participant Flow|OrthoPulse™|"Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.~Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
51522|NCT02267837|O2|Outcome|No OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment only, and no OrthoPulse™ treatments.~Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office."
51523|NCT02267837|O1|Outcome|OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.~Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
51524|NCT02267837|E2|Reported Event|No OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment only, and no OrthoPulse™ treatments.~Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office."
51571|NCT02267447|E1|Reported Event|Derivation Cohort|Eligible respondents to the combined 2001, 2003 and 2005 Canadian Community Health Surveys, conducted by Statistics Canada.
52067|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
51525|NCT02267837|E1|Reported Event|OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.~Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
51526|NCT02267824|B3|Baseline|Total|Total of all reporting groups
51527|NCT02267824|B2|Baseline|Control|Subjects assigned to this group receive only full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI), and no extra-oral OrthoPulse™ treatments. Treatment and follow-up appointments per the traditional practices of the PI and dental office.
51528|NCT02267824|B1|Baseline|Extra-Oral OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI), in conjunction with receiving daily extra-oral OrthoPulse™ treatments. Treatment and follow-up appointments per the traditional practices of the PI and dental office.~Extra-Oral OrthoPulse™: Patients carry out daily extra-oral OrthoPulse™ treatments at home."
51529|NCT02267824|P2|Participant Flow|Orthodontic Treatment (Control)|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment only.
51530|NCT02267824|P1|Participant Flow|Extraoral OrthoPulse® PBM|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® PBM treatments.
51531|NCT02267824|O2|Outcome|Orthodontic Treatment (Control)|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment, only.
51532|NCT02267824|O1|Outcome|Extraoral OrthoPulse® PBM and Orthodontic Treatment|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® PBM treatments.
51533|NCT02267824|E2|Reported Event|Orthodontic Treatment (Control)|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment, only.
51534|NCT02267824|E1|Reported Event|Extraoral OrthoPulse® PBM|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® photobiomudulation (PBM) treatments.
51535|NCT02267629|B1|Baseline|Experimental:Rapastinel (Formerly GLYX-13)|"10 mg/kg IV Rapastinel (formerly GLYX-13) infusion followed by assessments daily for a week, and weekly for a week.~Rapastinel (formerly GLYX-13): 10 mg/kg IV Rapastinel (formerly GLYX-13)"
51536|NCT02267629|P1|Participant Flow|Experimental:Rapastinel (Formerly GLYX-13)|"10 mg/kg IV Rapastinel (formerly GLYX-13) infusion followed by assessments daily for a week, and weekly for a week.~Rapastinel (formerly GLYX-13): 10 mg/kg IV Rapastinel (formerly GLYX-13)"
51537|NCT02267629|O1|Outcome|Experimental:Rapastinel (Formerly GLYX-13)|"10 mg/kg IV Rapastinel (formerly GLYX-13) infusion followed by assessments daily for a week, and weekly for a week.~Rapastinel (formerly GLYX-13): 10 mg/kg IV Rapastinel (formerly GLYX-13)"
51538|NCT02267629|O1|Outcome|Experimental:Rapastinel (Formerly GLYX-13)|"10 mg/kg IV Rapastinel (formerly GLYX-13) infusion followed by assessments daily for a week, and weekly for a week.~Rapastinel (formerly GLYX-13): 10 mg/kg IV Rapastinel (formerly GLYX-13)"
51539|NCT02267629|E1|Reported Event|Experimental:Rapastinel (Formerly GLYX-13)|"10 mg/kg IV Rapastinel (formerly GLYX-13) infusion followed by assessments daily for a week, and weekly for a week.~Rapastinel (formerly GLYX-13): 10 mg/kg IV Rapastinel (formerly GLYX-13)"
51540|NCT02267538|B3|Baseline|Total|Total of all reporting groups
51541|NCT02267538|B2|Baseline|CTRL Group|participants who recieved normal saline
51542|NCT02267538|B1|Baseline|DEX Group|participant who received dexmedetomidine
51543|NCT02267538|P2|Participant Flow|CTRL Group|participants who recieved normal saline
51544|NCT02267538|P1|Participant Flow|DEX Group|participant who received dexmedetomidine
51545|NCT02267538|O2|Outcome|CTRL Group|participants who recieved normal saline
51546|NCT02267538|O1|Outcome|DEX Group|participant who received dexmedetomidine
51547|NCT02267538|O2|Outcome|CTRL Group|participants who recieved normal saline
51548|NCT02267538|O1|Outcome|DEX Group|participant who received dexmedetomidine
51549|NCT02267538|O2|Outcome|CTRL Group|participants who recieved normal saline
51550|NCT02267538|O1|Outcome|DEX Group|participant who received dexmedetomidine
51551|NCT02267538|O2|Outcome|CTRL Group|participants who recieved normal saline
51552|NCT02267538|O1|Outcome|DEX Group|participant who received dexmedetomidine
51553|NCT02267538|O2|Outcome|CTRL Group|participants who recieved normal saline
51554|NCT02267538|O1|Outcome|DEX Group|participant who received dexmedetomidine
51555|NCT02267538|O2|Outcome|CTRL Group|participants who recieved normal saline
51556|NCT02267538|O1|Outcome|DEX Group|participant who received dexmedetomidine
51557|NCT02267538|O2|Outcome|CTRL Group|participants who recieved normal saline
51558|NCT02267538|O1|Outcome|DEX Group|participant who received dexmedetomidine
51559|NCT02267538|E2|Reported Event|CTRL Group|participants who recieved normal saline
51560|NCT02267538|E1|Reported Event|DEX Group|participant who received dexmedetomidine
51561|NCT02267447|B3|Baseline|Total|Total of all reporting groups
51562|NCT02267447|B2|Baseline|Validation Cohort|Eligible respondents to the 2007/2008 Canadian Community Health Survey.
51563|NCT02267447|B1|Baseline|Derivation Cohort|Eligible respondents to the combined 2001, 2003 and 2005 Canadian Community Health Surveys, conducted by Statistics Canada.
51564|NCT02267447|P2|Participant Flow|Validation Cohort|Eligible respondents to the 2007 and 2009 Canadian Community Health Surveys.
51565|NCT02267447|P1|Participant Flow|Derivation Cohort|Eligible respondents to the combined 2001, 2003 and 2005 Canadian Community Health Surveys, conducted by Statistics Canada.
51566|NCT02267447|O2|Outcome|Validation Cohort|Eligible respondents to the 2007/2008 Canadian Community Health Surveys.
51567|NCT02267447|O1|Outcome|Derivation Cohort|Eligible respondents to the combined 2001, 2003 and 2005 Canadian Community Health Surveys, conducted by Statistics Canada.
51568|NCT02267447|O2|Outcome|Validation Cohort|Eligible respondents to the 2007 /2008 Canadian Community Health Surveys.
51709|NCT02266381|O1|Outcome|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
51572|NCT02267187|B1|Baseline|Cotton Rolling Fat Grafting|"For the purpose of this study the fat grafting procedure is a research procedure. It is very important to note that this research procedure is not an experimental procedure. Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years. Fat grafting is known as a filler providing an accurate means to restoring facial soft tissue structure.~The processing of the fat graft material is done using a cotton rolling technique via a Tefla non-adherent gauze pad in a rolling technique that separates the aqueous and oil layers from the injected component."
51573|NCT02267187|P1|Participant Flow|Cotton Rolling Fat Grafting|"For the purpose of this study the fat grafting procedure is a research procedure. It is very important to note that this research procedure is not an experimental procedure. Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years. Fat grafting is known as a filler providing an accurate means to restoring facial soft tissue structure.~The processing of the fat graft material is done using a cotton rolling technique via a Tefla non-adherent gauze pad in a rolling technique that separates the aqueous and oil layers from the injected component."
51574|NCT02267187|O1|Outcome|Cotton Rolling Fat Grafting|"For the purpose of this study the fat grafting procedure is a research procedure. It is very important to note that this research procedure is not an experimental procedure. Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years. Fat grafting is known as a filler providing an accurate means to restoring facial soft tissue structure.~The processing of the fat graft material is done using a cotton rolling technique via a Tefla non-adherent gauze pad in a rolling technique that separates the aqueous and oil layers from the injected component."
51575|NCT02267187|O1|Outcome|Cotton Rolling Fat Grafting|"For the purpose of this study the fat grafting procedure is a research procedure. It is very important to note that this research procedure is not an experimental procedure. Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years. Fat grafting is known as a filler providing an accurate means to restoring facial soft tissue structure.~The processing of the fat graft material is done using a cotton rolling technique via a Tefla non-adherent gauze pad in a rolling technique that separates the aqueous and oil layers from the injected component."
51576|NCT02267187|O1|Outcome|Cotton Rolling Fat Grafting|"For the purpose of this study the fat grafting procedure is a research procedure. It is very important to note that this research procedure is not an experimental procedure. Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years. Fat grafting is known as a filler providing an accurate means to restoring facial soft tissue structure.~The processing of the fat graft material is done using a cotton rolling technique via a Tefla non-adherent gauze pad in a rolling technique that separates the aqueous and oil layers from the injected component."
51577|NCT02267187|E1|Reported Event|Cotton Rolling Fat Grafting|"For the purpose of this study the fat grafting procedure is a research procedure. It is very important to note that this research procedure is not an experimental procedure. Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years. Fat grafting is known as a filler providing an accurate means to restoring facial soft tissue structure.~The processing of the fat graft material is done using a cotton rolling technique via a Tefla non-adherent gauze pad in a rolling technique that separates the aqueous and oil layers from the injected component."
51578|NCT02267135|B3|Baseline|Total|Total of all reporting groups
51579|NCT02267135|B2|Baseline|Placebo|Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.
51580|NCT02267135|B1|Baseline|Secukinumab|Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
51581|NCT02267135|P2|Participant Flow|Placebo|Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.
51582|NCT02267135|P1|Participant Flow|Secukinumab|Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
51583|NCT02267135|O2|Outcome|Placebo|Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg
51584|NCT02267135|O1|Outcome|Secukinumab|Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
51585|NCT02267135|O2|Outcome|Placebo|Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg
51586|NCT02267135|O1|Outcome|Secukinumab|Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
51587|NCT02267135|O2|Outcome|Placebo|Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg
51588|NCT02267135|O1|Outcome|Secukinumab|Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
51589|NCT02267135|O2|Outcome|Placebo|Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.
51590|NCT02267135|O1|Outcome|Secukinumab|Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
51591|NCT02267135|O2|Outcome|Placebo|Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.
51592|NCT02267135|O1|Outcome|Secukinumab|Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
51593|NCT02267135|O2|Outcome|Placebo|Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg
51594|NCT02267135|O1|Outcome|Secukinumab|Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
51595|NCT02267135|O2|Outcome|Placebo|Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.
51596|NCT02267135|O1|Outcome|Secukinumab|Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
51597|NCT02267135|O1|Outcome|Secukinumab|Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
51598|NCT02267135|O2|Outcome|Placebo|Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.
51599|NCT02267135|O1|Outcome|Secukinumab|Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
51600|NCT02267135|O2|Outcome|Placebo|Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg
51601|NCT02267135|O1|Outcome|Secukinumab|Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
51602|NCT02267135|O2|Outcome|Placebo|Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.
51603|NCT02267135|O1|Outcome|Secukinumab|Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
51604|NCT02267135|O2|Outcome|Placebo|Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.
51605|NCT02267135|O1|Outcome|Secukinumab|Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
51606|NCT02267135|O2|Outcome|Placebo|Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.
51607|NCT02267135|O1|Outcome|Secukinumab|Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
51608|NCT02267135|E4|Reported Event|Treatment Period 1 & 2: Any Secukinumab|
51609|NCT02267135|E3|Reported Event|Treatment Period 2 Placebo/Secukinumab 300 mg|Treatment Period 2 Placebo/Secukinumab 300 mg
51610|NCT02267135|E2|Reported Event|Treatment Period 1 Placebo|Treatment Period 1 Placebo
51611|NCT02267135|E1|Reported Event|Treatment Period 1 Secukinumab 300 mg|Treatment Period 1 Secukinumab 300 mg
51710|NCT02266381|O3|Outcome|Combined Group|Patients in Combined group undergo MPCNL using US combined with fluoroscopy-guided renal access.
52068|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
51612|NCT02267083|B1|Baseline|GPX-150|"GPX-150 for Injection, 265 mg/m2, every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity, or subject withdrawal.~GPX-150 for Injection: GPX-150 at a starting dose of 265 mg/m2 every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity. The dose of GPX-150 may be reduced by 25% if any dose reduction criteria are met. Two reductions are allowed per subject during the course of the study."
51613|NCT02267083|P1|Participant Flow|GPX-150|"GPX-150 for Injection, 265 mg/m2, every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity, or subject withdrawal.~GPX-150 for Injection: GPX-150 at a starting dose of 265 mg/m2 every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity. The dose of GPX-150 may be reduced by 25% if any dose reduction criteria are met. Two reductions are allowed per subject during the course of the study."
51614|NCT02267083|O1|Outcome|GPX-150|"GPX-150 for Injection, 265 mg/m2, every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity, or subject withdrawal.~GPX-150 for Injection: GPX-150 at a starting dose of 265 mg/m2 every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity. The dose of GPX-150 may be reduced by 25% if any dose reduction criteria are met. Two reductions are allowed per subject during the course of the study."
51615|NCT02267083|O1|Outcome|GPX-150|"GPX-150 for Injection, 265 mg/m2, every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity, or subject withdrawal.~GPX-150 for Injection: GPX-150 at a starting dose of 265 mg/m2 every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity. The dose of GPX-150 may be reduced by 25% if any dose reduction criteria are met. Two reductions are allowed per subject during the course of the study."
51616|NCT02267083|O1|Outcome|GPX-150|"GPX-150 for Injection, 265 mg/m2, every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity, or subject withdrawal.~GPX-150 for Injection: GPX-150 at a starting dose of 265 mg/m2 every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity. The dose of GPX-150 may be reduced by 25% if any dose reduction criteria are met. Two reductions are allowed per subject during the course of the study."
51617|NCT02267083|O1|Outcome|GPX-150|"GPX-150 for Injection, 265 mg/m2, every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity, or subject withdrawal.~GPX-150 for Injection: GPX-150 at a starting dose of 265 mg/m2 every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity. The dose of GPX-150 may be reduced by 25% if any dose reduction criteria are met. Two reductions are allowed per subject during the course of the study."
51618|NCT02267083|E1|Reported Event|GPX-150|"GPX-150 for Injection, 265 mg/m2, every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity, or subject withdrawal.~GPX-150 for Injection: GPX-150 at a starting dose of 265 mg/m2 every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity. The dose of GPX-150 may be reduced by 25% if any dose reduction criteria are met. Two reductions are allowed per subject during the course of the study."
51619|NCT02266875|B3|Baseline|Total|Total of all reporting groups
51620|NCT02266875|B2|Baseline|Standard Saline|"Patients will receive standard saline (0.9%) saline along with standard 2.5 mg. albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).~Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale.~standard saline"
51621|NCT02266875|B1|Baseline|Hypertonic Saline|"Patients will receive nebulized hypertonic (3%) saline along with standard 2.5 mg. albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).~Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale.~hypertonic saline"
51622|NCT02266875|P2|Participant Flow|Standard Saline|"Patients will receive standard saline (0.9%) saline along with standard 2.5 mg. albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).~Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale.~standard saline"
51623|NCT02266875|P1|Participant Flow|Hypertonic Saline|"Patients will receive nebulized hypertonic (3%) saline along with standard 2.5 mg. albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).~Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale.~hypertonic saline"
51624|NCT02266875|O2|Outcome|Standard Saline|"Patients will receive standard saline (0.9%) saline along with standard 2.5 mg. albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).~Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale.~standard saline"
51625|NCT02266875|O1|Outcome|Hypertonic Saline|"Patients will receive nebulized hypertonic (3%) saline along with standard 2.5 mg. albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).~Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale.~hypertonic saline"
51626|NCT02266875|O2|Outcome|Standard Saline|"Patients will receive standard saline (0.9%) saline along with standard 2.5 mg. albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).~Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale.~standard saline"
51627|NCT02266875|O1|Outcome|Hypertonic Saline|"Patients will receive nebulized hypertonic (3%) saline along with standard 2.5 mg. albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).~Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale.~hypertonic saline"
51628|NCT02266875|O2|Outcome|Standard Saline|"Patients will receive standard saline (0.9%) saline along with standard 2.5 mg. albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).~Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale.~standard saline"
51629|NCT02266875|O1|Outcome|Hypertonic Saline|"Patients will receive nebulized hypertonic (3%) saline along with standard 2.5 mg. albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).~Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale.~hypertonic saline"
51630|NCT02266875|E2|Reported Event|Standard Saline|"Patients will receive standard saline (0.9%) saline along with standard 2.5 mg albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).~Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale."
51631|NCT02266875|E1|Reported Event|Hypertonic Saline|"Patients will receive nebulized hypertonic (3%) saline along with standard 2.5 mg albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).~Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale."
51632|NCT02266810|B3|Baseline|Total|Total of all reporting groups
51633|NCT02266810|B2|Baseline|PROPEL Nova Sinus Implant and No Implant Cohort 2|"This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned.~PROPEL Mini or Nova Sinus Implant.: Placement of sinus implant following frontal sinus surgery"
51634|NCT02266810|B1|Baseline|PROPEL Mini Sinus Implant and No Implant Cohort 1|"This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned.~PROPEL Mini or Nova Sinus Implant.: Placement of sinus implant following frontal sinus surgery"
51635|NCT02266810|P2|Participant Flow|PROPEL Nova Sinus Implant|"This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned.~PROPEL Nova Sinus Implant: Placement of sinus implant following frontal sinus surgery"
51636|NCT02266810|P1|Participant Flow|PROPEL Mini Sinus Implant|"This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned.~PROPEL Mini Sinus Implant: Placement of sinus implant following frontal sinus surgery"
51637|NCT02266810|O2|Outcome|Sinus Surgery Only: Cohort 2|"Sinus surgery with standard post-operative care.~Sinus Surgery alone: Sinus surgery only, without implant placement"
51638|NCT02266810|O1|Outcome|PROPEL Nova Sinus Implant|"Propel Nova placed in frontal sinus opening following ESS~PROPEL Nova Sinus Implant.: Placement of sinus implant following frontal sinus surgery"
51639|NCT02266810|O2|Outcome|Sinus Surgery Alone: Cohort 2|"Sinus Surgery only: cohort 2: ESS with standard post-operative care.~Sinus Surgery alone: Sinus surgery only, without implant placement"
51640|NCT02266810|O1|Outcome|PROPEL Nova Sinus Implant|"Propel Nova placed in frontal sinus opening following ESS~Propel Nova Sinus Implant: Placement of sinus implant following frontal sinus surgery"
51641|NCT02266810|O2|Outcome|Sinus Surgery Only: Cohort 2|"Sinus surgery with standard post-operative care.~Sinus Surgery alone: Sinus surgery only, without implant placement"
51642|NCT02266810|O1|Outcome|PROPEL Nova Sinus Implant|"Propel Nova placed in frontal sinus opening following ESS~PROPEL Nova Sinus Implant.: Placement of sinus implant following frontal sinus surgery"
51643|NCT02266810|O2|Outcome|Sinus Surgery Only: Cohort 2|"This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned.~Sinus Surgery only: Sinus surgery only, without implant placement"
51644|NCT02266810|O1|Outcome|PROPEL Nova Sinus Implant|"This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned.~PROPEL Nova Sinus Implant: Placement of sinus implant following frontal sinus surgery"
51645|NCT02266810|O2|Outcome|Sinus Surgery Only: Cohort 1|"Sinus surgery with standard post-operative care.~Sinus Surgery alone: Sinus surgery only, without implant placement"
51646|NCT02266810|O1|Outcome|PROPEL Mini Sinus Implant|"Propel Mini placed in frontal sinus opening following ESS~PROPEL Mini Sinus Implant.: Placement of sinus implant following frontal sinus surgery"
51647|NCT02266810|O2|Outcome|Sinus Surgery Alone: Cohort 1|"Sinus Surgery only: cohort 1: ESS with standard post-operative care.~Sinus Surgery alone: Sinus surgery only, without implant placement"
51648|NCT02266810|O1|Outcome|PROPEL Mini Sinus Implant|"Propel Mini placed in frontal sinus opening following ESS~PROPEL Mini Sinus Implant.: Placement of sinus implant following frontal sinus surgery"
51649|NCT02266810|O2|Outcome|Sinus Surgery Only: Cohort 1|"Sinus surgery with standard post-operative care.~Sinus Surgery alone: Sinus surgery only, without implant placement"
51650|NCT02266810|O1|Outcome|PROPEL Mini Sinus Implant|"Propel Mini placed in frontal sinus opening following ESS~PROPEL Mini Sinus Implant.: Placement of sinus implant following frontal sinus surgery"
51651|NCT02266810|O2|Outcome|Sinus Surgery Only: Cohort 1|"This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned.~Sinus Surgery only: Sinus surgery only, without implant placement"
51652|NCT02266810|O1|Outcome|PROPEL Mini Sinus Implant|"This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned.~PROPEL Mini Sinus Implant: Placement of sinus implant following frontal sinus surgery"
51653|NCT02266810|O2|Outcome|Sinus Surgery Only: Cohort 2|"Sinus surgery with standard post-operative care.~Sinus Surgery alone: Sinus surgery only, without implant placement"
51654|NCT02266810|O1|Outcome|PROPEL Nova Sinus Implant|"Propel Nova placed in frontal sinus opening following ESS~Propel Nova Sinus Implant: Placement of sinus implant following frontal sinus surgery"
51655|NCT02266810|O2|Outcome|Sinus Surgery Only: Cohort 1|"Sinus surgery with standard post-operative care.~Sinus Surgery alone: Sinus surgery only, without implant placement"
51656|NCT02266810|O1|Outcome|PROPEL Mini Sinus Implant|"Propel Mini placed in frontal sinus opening following ESS~PROPEL Mini Sinus Implant.: Placement of sinus implant following frontal sinus surgery"
51657|NCT02266810|E2|Reported Event|PROPEL Nova Sinus Implant|"Propel Nova placed in frontal sinus opening following ESS~PROPEL Nova Sinus Implant.: Placement of sinus implant following frontal sinus surgery"
51658|NCT02266810|E1|Reported Event|PROPEL Mini Sinus Implant|"Propel Mini placed in frontal sinus opening following ESS~PROPEL Mini Sinus Implant.: Placement of sinus implant following frontal sinus surgery"
51659|NCT02266797|B3|Baseline|Total|Total of all reporting groups
51660|NCT02266797|B2|Baseline|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
51711|NCT02266381|O2|Outcome|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
51661|NCT02266797|B1|Baseline|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
51662|NCT02266797|P2|Participant Flow|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
51663|NCT02266797|P1|Participant Flow|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
51664|NCT02266797|O2|Outcome|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
51665|NCT02266797|O1|Outcome|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
51666|NCT02266797|O2|Outcome|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
51667|NCT02266797|O1|Outcome|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
51668|NCT02266797|O2|Outcome|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
51669|NCT02266797|O1|Outcome|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
51670|NCT02266797|O2|Outcome|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
51671|NCT02266797|O1|Outcome|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
51672|NCT02266797|O2|Outcome|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
51673|NCT02266797|O1|Outcome|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
51674|NCT02266797|O2|Outcome|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
51675|NCT02266797|O1|Outcome|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
51676|NCT02266797|E2|Reported Event|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
51677|NCT02266797|E1|Reported Event|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
51678|NCT02266472|B3|Baseline|Total|Total of all reporting groups
51712|NCT02266381|O1|Outcome|US-guided Group|Patients in US-guided undergo MPCNL using only US-guided renal access.
52069|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
51679|NCT02266472|B2|Baseline|Fed 10mg+1000mg Single/FDC (RT)|Subjects received in period 1 a single dose of 10 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal. 2 treatments separated by a wash-out period of at least 7 days.
51680|NCT02266472|B1|Baseline|Fed 10mg+1000mg FDC/Single (TR)|Subjects received in period 1 a single dose of 10 mg empagliflozin/1000 mg metformin hydrochloride (HCl) extended release (XR) (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 10 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal. 2 treatments separated by a wash-out period of at least 7 days.
51681|NCT02266472|P2|Participant Flow|Fed 10mg+1000mg Single/FDC (RT)|Subjects received in period 1 a single dose of 10 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal. 2 treatments separated by a wash-out period of at least 7 days.
51682|NCT02266472|P1|Participant Flow|Fed 10mg+1000mg Fixed Dose Combination (FDC)/Single (TR)|Subjects received in period 1 a single dose of 10 mg empagliflozin/1000 mg metformin hydrochloride (HCl) extended release (XR) (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 10 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal. 2 treatments separated by a wash-out period of at least 7 days.
51683|NCT02266472|O2|Outcome|Fed 10mg+1000mg Single (R)|Subjects received a single dose of 10 mg empagliflozin (1 tablet) together with a single dose of 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
51684|NCT02266472|O1|Outcome|Fed 10mg+ 1000mg FDC (T)|Subjects received a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
51685|NCT02266472|O2|Outcome|Fed 10mg+1000mg Single (R)|Subjects received a single dose of 10 mg empagliflozin (1 tablet) together with a single dose of 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
51686|NCT02266472|O1|Outcome|Fed 10mg+ 1000mg FDC (T)|Subjects received a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
51687|NCT02266472|O2|Outcome|Fed 10mg+1000mg Single (R)|Subjects received a single dose of 10 mg empagliflozin (1 tablet) together with a single dose of 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
51688|NCT02266472|O1|Outcome|Fed 10mg+ 1000mg FDC (T)|Subjects received a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
51689|NCT02266472|O2|Outcome|Fed 10mg+1000mg Single (R)|Subjects received a single dose of 10 mg empagliflozin (1 tablet) together with a single dose of 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
51690|NCT02266472|O1|Outcome|Fed 10mg+ 1000mg FDC (T)|Subjects received a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
51691|NCT02266472|O2|Outcome|Fed 10mg+1000mg Single (R)|Subjects received a single dose of 10 mg empagliflozin (1 tablet) together with a single dose of 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
51692|NCT02266472|O1|Outcome|Fed 10mg+ 1000mg FDC (T)|Subjects received a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
51693|NCT02266472|O2|Outcome|Fed 10mg+1000mg Single (R)|Subjects received a single dose of 10 mg empagliflozin (1 tablet) together with a single dose of 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
51694|NCT02266472|O1|Outcome|Fed 10mg+ 1000mg FDC (T)|Subjects received a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
51695|NCT02266472|E2|Reported Event|Fed 10mg+ 1000mg FDC (T)|Subjects received a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
51696|NCT02266472|E1|Reported Event|Fed 10mg+1000mg Single (R)|Subjects received a single dose of 10 mg empagliflozin (1 tablet) together with a single dose of 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
51697|NCT02266381|B4|Baseline|Total|Total of all reporting groups
51698|NCT02266381|B3|Baseline|Combined-guided Group|Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
51699|NCT02266381|B2|Baseline|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
51700|NCT02266381|B1|Baseline|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
51701|NCT02266381|P3|Participant Flow|Combined-guided Group|Patients in combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
51702|NCT02266381|P2|Participant Flow|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
51703|NCT02266381|P1|Participant Flow|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
51704|NCT02266381|O3|Outcome|Combined-guided Group|Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
51705|NCT02266381|O2|Outcome|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
51706|NCT02266381|O1|Outcome|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
51707|NCT02266381|O3|Outcome|Combined-guided Group|Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
51708|NCT02266381|O2|Outcome|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
52070|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
51714|NCT02266381|O2|Outcome|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
51715|NCT02266381|O1|Outcome|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
51716|NCT02266381|E3|Reported Event|Combined-guided Group|Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
51717|NCT02266381|E2|Reported Event|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
51718|NCT02266381|E1|Reported Event|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
51719|NCT02266277|B7|Baseline|Total|Total of all reporting groups
51720|NCT02266277|B6|Baseline|Arm 6: No IVR Call|Patients identified as non e-portal users will not receive any outreach
51721|NCT02266277|B5|Baseline|Arm 5: IVR Call|"Patients identified as non e-portal users will receive an IVR call only~Arm 5: IVR call: Non electronic patient portal users will be randomized to receive an IVR call with educational information about influenza vaccines, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
51722|NCT02266277|B4|Baseline|Arm 4: No E-portal Message With no IVR Call|Patients identified as e-portal users will receive neither an e-portal message nor an IVR call
51723|NCT02266277|B3|Baseline|Arm 3: No E-portal Message With IVR Call|"Patients identified as e-portal users will receive an IVR call only~Arm 3: No e-portal message with IVR call: Active electronic patient portal users will be randomized to receive an IVR call. The IVR call will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
51724|NCT02266277|B2|Baseline|Arm 2: E-portal Message With no IVR Call|"Patients identified as e-portal users will receive an e-portal message only~Arm 2: E-portal message with no IVR call: Active electronic patient portal users will be randomized to receive only an e-portal message. The e-portal message will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
51725|NCT02266277|B1|Baseline|Arm 1: E-portal Message With IVR Call|"Patients identified as e-portal users will receive an e-portal message with IVR call~Arm 1: E-portal message with IVR call: Active electronic patient portal users will be randomized to receive an e-portal message and IVR calls. Both methods of outreach will provide patients with educational information about influenza vaccination, notify patients of local flu clinic schedules and elicit patient response to vaccination status and barriers."
51726|NCT02266277|P6|Participant Flow|Arm 6: No IVR Call|Patients identified as non e-portal users will not receive any outreach
51727|NCT02266277|P5|Participant Flow|Arm 5: IVR Call|"Patients identified as non e-portal users will receive an IVR call only~Arm 5: IVR call: Non electronic patient portal users will be randomized to receive an IVR call with educational information about influenza vaccines, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
51728|NCT02266277|P4|Participant Flow|Arm 4: No E-portal Message With no IVR Call|Patients identified as e-portal users will receive neither an e-portal message nor an IVR call
51729|NCT02266277|P3|Participant Flow|Arm 3: No E-portal Message With IVR Call|"Patients identified as e-portal users will receive an IVR call only~Arm 3: No e-portal message with IVR call: Active electronic patient portal users will be randomized to receive an IVR call. The IVR call will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
51730|NCT02266277|P2|Participant Flow|Arm 2: E-portal Message With no IVR Call|"Patients identified as e-portal users will receive an e-portal message only~Arm 2: E-portal message with no IVR call: Active electronic patient portal users will be randomized to receive only an e-portal message. The e-portal message will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
51731|NCT02266277|P1|Participant Flow|Arm 1: E-portal Message With IVR Call|"Patients identified as e-portal users will receive an e-portal message with Interactive Voice Recognition (IVR) call~Arm 1: E-portal message with IVR call: Active electronic patient portal users will be randomized to receive an e-portal message and IVR calls. Both methods of outreach will provide patients with educational information about influenza vaccination, notify patients of local flu clinic schedules and elicit patient response to vaccination status and barriers."
51732|NCT02266277|O2|Outcome|IVR Self-Report|Patients who received IVR questionnaire.
51733|NCT02266277|O1|Outcome|Portal Self-Report|Patients who received portal questionnaire.
51734|NCT02266277|O6|Outcome|Arm 6: No IVR Call|Patients identified as non e-portal users will not receive any outreach
51735|NCT02266277|O5|Outcome|Arm 5: IVR Call|"Patients identified as non e-portal users will receive an IVR call only~Arm 5: IVR call: Non electronic patient portal users will be randomized to receive an IVR call with educational information about influenza vaccines, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
51736|NCT02266277|O4|Outcome|Arm 4: No E-portal Message With no IVR Call|Patients identified as e-portal users will receive neither an e-portal message nor an IVR call
51737|NCT02266277|O3|Outcome|Arm 3: No E-portal Message With IVR Call|"Patients identified as e-portal users will receive an IVR call only~Arm 3: No e-portal message with IVR call: Active electronic patient portal users will be randomized to receive an IVR call. The IVR call will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
51738|NCT02266277|O2|Outcome|Arm 2: E-portal Message With no IVR Call|"Patients identified as e-portal users will receive an e-portal message only~Arm 2: E-portal message with no IVR call: Active electronic patient portal users will be randomized to receive only an e-portal message. The e-portal message will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
51771|NCT02265796|P1|Participant Flow|Ranolazine|"Ranolazine 500 mg tablets~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Ranolazine: Ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks"
53721|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
51739|NCT02266277|O1|Outcome|Arm 1: E-portal Message With IVR Call|"Patients identified as e-portal users will receive an e-portal message with IVR call~Arm 1: E-portal message with IVR call: Active electronic patient portal users will be randomized to receive an e-portal message and IVR calls. Both methods of outreach will provide patients with educational information about influenza vaccination, notify patients of local flu clinic schedules and elicit patient response to vaccination status and barriers."
51740|NCT02266277|O6|Outcome|Arm 6: No IVR Call|Patients identified as non e-portal users will not receive any outreach
51741|NCT02266277|O5|Outcome|Arm 5: IVR Call|"Patients identified as non e-portal users will receive an IVR call only~Arm 5: IVR call: Non electronic patient portal users will be randomized to receive an IVR call with educational information about influenza vaccines, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
51742|NCT02266277|O4|Outcome|Arm 4: No E-portal Message With no IVR Call|Patients identified as e-portal users will receive neither an e-portal message nor an IVR call
51743|NCT02266277|O3|Outcome|Arm 3: No E-portal Message With IVR Call|"Patients identified as e-portal users will receive an IVR call only~Arm 3: No e-portal message with IVR call: Active electronic patient portal users will be randomized to receive an IVR call. The IVR call will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
51744|NCT02266277|O2|Outcome|Arm 2: E-portal Message With no IVR Call|"Patients identified as e-portal users will receive an e-portal message only~Arm 2: E-portal message with no IVR call: Active electronic patient portal users will be randomized to receive only an e-portal message. The e-portal message will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
51745|NCT02266277|O1|Outcome|Arm 1: E-portal Message With IVR Call|"Patients identified as e-portal users will receive an e-portal message with IVR call~Arm 1: E-portal message with IVR call: Active electronic patient portal users will be randomized to receive an e-portal message and IVR calls. Both methods of outreach will provide patients with educational information about influenza vaccination, notify patients of local flu clinic schedules and elicit patient response to vaccination status and barriers."
51746|NCT02266277|E6|Reported Event|Arm 6: No IVR Call|Patients identified as non e-portal users will not receive any outreach
51747|NCT02266277|E5|Reported Event|Arm 5: IVR Call|"Patients identified as non e-portal users will receive an IVR call only~Arm 5: IVR call: Non electronic patient portal users will be randomized to receive an IVR call with educational information about influenza vaccines, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
51748|NCT02266277|E4|Reported Event|Arm 4: No E-portal Message With no IVR Call|Patients identified as e-portal users will receive neither an e-portal message nor an IVR call
51749|NCT02266277|E3|Reported Event|Arm 3: No E-portal Message With IVR Call|"Patients identified as e-portal users will receive an IVR call only~Arm 3: No e-portal message with IVR call: Active electronic patient portal users will be randomized to receive an IVR call. The IVR call will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
51750|NCT02266277|E2|Reported Event|Arm 2: E-portal Message With no IVR Call|"Patients identified as e-portal users will receive an e-portal message only~Arm 2: E-portal message with no IVR call: Active electronic patient portal users will be randomized to receive only an e-portal message. The e-portal message will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
51751|NCT02266277|E1|Reported Event|Arm 1: E-portal Message With IVR Call|"Patients identified as e-portal users will receive an e-portal message with IVR call~Arm 1: E-portal message with IVR call: Active electronic patient portal users will be randomized to receive an e-portal message and IVR calls. Both methods of outreach will provide patients with educational information about influenza vaccination, notify patients of local flu clinic schedules and elicit patient response to vaccination status and barriers."
51752|NCT02265848|B3|Baseline|Total|Total of all reporting groups
51753|NCT02265848|B2|Baseline|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
51754|NCT02265848|B1|Baseline|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
51755|NCT02265848|P2|Participant Flow|Treatment Group B|"Subjects randomized to the treatment group B will begin the 7 week study per sequence (e.g., Low frequency first, then High frequency and High frequency first, then Low frequency), with each stimulation modes lasting approximately 3 weeks with 7 to 10 days of wash off periods in between. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study."
51756|NCT02265848|P1|Participant Flow|Treatment Group A|"Subjects randomized to the treatment group A will begin the 7 week study per sequence (e.g., High frequency first, then Low frequency and Low frequency first, then High frequency), with each stimulation modes lasting approximately 3 weeks with 7 to 10 days of wash off periods in between. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study."
51772|NCT02265796|O2|Outcome|Sugar Pill|"Sugar pill that looks like the drug ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Sugar pill: 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks"
53722|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
51757|NCT02265848|O2|Outcome|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
51758|NCT02265848|O1|Outcome|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
51759|NCT02265848|O2|Outcome|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
51760|NCT02265848|O1|Outcome|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
51761|NCT02265848|O2|Outcome|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
51762|NCT02265848|O1|Outcome|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
51763|NCT02265848|O2|Outcome|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
51764|NCT02265848|O1|Outcome|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
51765|NCT02265848|E2|Reported Event|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
51766|NCT02265848|E1|Reported Event|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
51767|NCT02265796|B3|Baseline|Total|Total of all reporting groups
51768|NCT02265796|B2|Baseline|Sugar Pill|"Sugar pill that looks like the drug ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Sugar pill: 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks"
51769|NCT02265796|B1|Baseline|Ranolazine|"Ranolazine 500 mg tablets~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Ranolazine: Ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks"
51770|NCT02265796|P2|Participant Flow|Sugar Pill|"Sugar pill that looks like the drug ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Sugar pill: 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks"
52071|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
51773|NCT02265796|O1|Outcome|Ranolazine|"Ranolazine 500 mg tablets~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Ranolazine: Ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks"
51774|NCT02265796|O2|Outcome|Sugar Pill|"Sugar pill that looks like the drug ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Sugar pill: 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks"
51775|NCT02265796|O1|Outcome|Ranolazine|"Ranolazine 500 mg tablets~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Ranolazine: Ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks"
51776|NCT02265796|O2|Outcome|Sugar Pill|"Sugar pill that looks like the drug ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Sugar pill: 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks"
51777|NCT02265796|O1|Outcome|Ranolazine|"Ranolazine 500 mg tablets~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Ranolazine: Ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks"
51778|NCT02265796|E2|Reported Event|Sugar Pill|"Sugar pill that looks like the drug ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Sugar pill: 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks"
51779|NCT02265796|E1|Reported Event|Ranolazine|"Ranolazine 500 mg tablets~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Ranolazine: Ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks"
51780|NCT02265783|B1|Baseline|The Oxicable Pulse Oximetry Device|The subjects sit in a chair while a pulse oximetry sensor, hooked to the Oxicable pulse oximeter and a data collection system, is placed and removed in a certain sequence. This is done to demonstrate that the sensor-off feature displays per specifications when subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature.
51781|NCT02265783|P1|Participant Flow|The Oxicable Pulse Oximetry Device|The subjects sit in a chair while a pulse oximetry sensor, hooked to the Oxicable pulse oximeter and a data collection system, is placed and removed in a certain sequence. This is done to demonstrate that the sensor-off feature displays per specifications when subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature.
51782|NCT02265783|O1|Outcome|The Oxicable Pulse Oximetry Device|The subjects sit in a chair while a pulse oximetry sensor, hooked to the Oxicable pulse oximeter and a data collection system, is placed and removed in a certain sequence. This is done to demonstrate that the sensor-off feature displays per specifications when subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature.
51783|NCT02265783|E1|Reported Event|The Oxicable Pulse Oximetry Device|The subjects sit in a chair while a pulse oximetry sensor, hooked to the Oxicable pulse oximeter and a data collection system, is placed and removed in a certain sequence. This is done to demonstrate that the sensor-off feature displays per specifications when subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature.
51784|NCT02265237|B5|Baseline|Total|Total of all reporting groups
51785|NCT02265237|B4|Baseline|Arm D|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 SOF/pegIFN/RBV or SOF/RBV treatment-experienced.
51786|NCT02265237|B3|Baseline|Arm C|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.
51787|NCT02265237|B2|Baseline|Arm B|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
51788|NCT02265237|B1|Baseline|Arm A|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.
51789|NCT02265237|P4|Participant Flow|Arm D|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 SOF/pegIFN/RBV or SOF/RBV treatment-experienced.
51790|NCT02265237|P3|Participant Flow|Arm C|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.
51791|NCT02265237|P2|Participant Flow|Arm B|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
51792|NCT02265237|P1|Participant Flow|Arm A|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.
51793|NCT02265237|O3|Outcome|Arm C|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.
51794|NCT02265237|O2|Outcome|Arm B|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
51795|NCT02265237|O1|Outcome|Arm A|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.
51796|NCT02265237|O3|Outcome|Arm C|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.
51797|NCT02265237|O2|Outcome|Arm B|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
51798|NCT02265237|O1|Outcome|Arm A|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.
51799|NCT02265237|O2|Outcome|Arm C|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.
51800|NCT02265237|O1|Outcome|Arm B|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
51801|NCT02265237|O2|Outcome|Arm B|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
51802|NCT02265237|O1|Outcome|Arm A|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.
51803|NCT02265237|O3|Outcome|Arm C|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.
51804|NCT02265237|O2|Outcome|Arm B|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
51805|NCT02265237|O1|Outcome|Arm A|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.
51806|NCT02265237|E4|Reported Event|Arm D|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 SOF/pegIFN/RBV or SOF/RBV treatment-experienced.
51807|NCT02265237|E3|Reported Event|Arm C|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.
51808|NCT02265237|E2|Reported Event|Arm B|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
51809|NCT02265237|E1|Reported Event|Arm A|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.
51810|NCT02264977|B1|Baseline|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis~Branched TAG® Device"
51811|NCT02264977|P1|Participant Flow|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis~Branched TAG® Device"
51812|NCT02264977|O1|Outcome|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis~Branched TAG® Device"
51813|NCT02264977|O1|Outcome|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis~Branched TAG® Device"
51814|NCT02264977|O1|Outcome|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis~Branched TAG® Device"
51815|NCT02264977|O1|Outcome|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis~Branched TAG® Device"
51816|NCT02264977|O1|Outcome|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis~Branched TAG® Device"
51817|NCT02264977|E1|Reported Event|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis~Branched TAG® Device"
51818|NCT02264821|B4|Baseline|Total|Total of all reporting groups
51819|NCT02264821|B3|Baseline|Placebo|"intrathecal saline and saline infiltration~placebo: placebo in spinal anaesthesia and in wound infiltration"
51820|NCT02264821|B2|Baseline|Rachi Morphine|"100 µg intrathecal morphine and saline infiltration~intrathecal morphine: 100 µg added to the spinal anaesthesia"
51821|NCT02264821|B1|Baseline|Ropivacaine Infiltration|"ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline~ropivacaine infiltration: wound infiltration"
51822|NCT02264821|P3|Participant Flow|Placebo|"intrathecal saline and saline infiltration~placebo: placebo in spinal anaesthesia and in wound infiltration"
51823|NCT02264821|P2|Participant Flow|Rachi Morphine|"100 µg intrathecal morphine and saline infiltration~intrathecal morphine: 100 µg added to the spinal anaesthesia"
51824|NCT02264821|P1|Participant Flow|Ropivacaine Infiltration|"ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline~ropivacaine infiltration: wound infiltration"
51825|NCT02264821|O3|Outcome|Placebo|"intrathecal saline and saline infiltration~placebo: placebo in spinal anaesthesia and in wound infiltration"
51826|NCT02264821|O2|Outcome|Rachi Morphine|"100 µg intrathecal morphine and saline infiltration~intrathecal morphine: 100 µg added to the spinal anaesthesia"
51827|NCT02264821|O1|Outcome|Ropivacaine Infiltration|"ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline~ropivacaine infiltration: wound infiltration"
51828|NCT02264821|O3|Outcome|Placebo|"intrathecal saline and saline infiltration~placebo: placebo in spinal anaesthesia and in wound infiltration"
51829|NCT02264821|O2|Outcome|Rachi Morphine|"100 µg intrathecal morphine and saline infiltration~intrathecal morphine: 100 µg added to the spinal anaesthesia"
51830|NCT02264821|O1|Outcome|Ropivacaine Infiltration|"ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline~ropivacaine infiltration: wound infiltration"
51831|NCT02264821|E3|Reported Event|Placebo|"intrathecal saline and saline infiltration~placebo: placebo in spinal anaesthesia and in wound infiltration"
51832|NCT02264821|E2|Reported Event|Rachi Morphine|"100 µg intrathecal morphine and saline infiltration~intrathecal morphine: 100 µg added to the spinal anaesthesia"
51833|NCT02264821|E1|Reported Event|Ropivacaine Infiltration|"ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline~ropivacaine infiltration: wound infiltration"
51834|NCT02264249|B4|Baseline|Total|Total of all reporting groups
51835|NCT02264249|B3|Baseline|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
51836|NCT02264249|B2|Baseline|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
51837|NCT02264249|B1|Baseline|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose – ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
51838|NCT02264249|P3|Participant Flow|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
51862|NCT02263911|O1|Outcome|Baricitinib T1|Baricitinib 2 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods.
51839|NCT02264249|P2|Participant Flow|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
51840|NCT02264249|P1|Participant Flow|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose – ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
51841|NCT02264249|O3|Outcome|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
51842|NCT02264249|O2|Outcome|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
51843|NCT02264249|O1|Outcome|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose – ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
51844|NCT02264249|O3|Outcome|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
51845|NCT02264249|O2|Outcome|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
51846|NCT02264249|O1|Outcome|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose – ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
51847|NCT02264249|O3|Outcome|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
51848|NCT02264249|O2|Outcome|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
51849|NCT02264249|O1|Outcome|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose – ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
51850|NCT02264249|E3|Reported Event|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
51851|NCT02264249|E2|Reported Event|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
51852|NCT02264249|E1|Reported Event|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose – ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
51853|NCT02263911|B1|Baseline|Overall Study|All randomized participants.
51854|NCT02263911|P4|Participant Flow|Baricitinib Dosing Sequence 4|Single oral dose of study drug daily on 5 occasions: R1 = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, T1 = Baricitinib 2 × 4 mg commercial formulation tablets in a fasted state, T2 = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, R2 = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, and T2F = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days.
51855|NCT02263911|P3|Participant Flow|Baricitinib Dosing Sequence 3|Single oral dose of study drug daily on 5 occasions: T1 = Baricitinib 2 × 4 mg commercial formulation tablets in a fasted state, R1 = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, R2 = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, T2 = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, and T2F = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days.
51856|NCT02263911|P2|Participant Flow|Baricitinib Dosing Sequence 2|Single oral dose of study drug daily on 5 occasions: R1 = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, T1 = Baricitinib 2 × 4 mg commercial formulation tablets in a fasted state, R2 = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, T2 = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, and T2F = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days.
51857|NCT02263911|P1|Participant Flow|Baricitinib Dosing Sequence 1|Single oral dose of study drug daily on 5 occasions: Test Treatment 1 (T1) = Baricitinib 2 × 4 milligram (mg) commercial formulation tablets in a fasted state, Reference Treatment 1 (R1) = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, Test Treatment 2 (T2) = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, Reference Treatment 2 (R2) = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, and (T2F) = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days.
51858|NCT02263911|O5|Outcome|Baricitinib T2F|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD with a low-fat meal on Day 1 in one of five periods.
51859|NCT02263911|O4|Outcome|Baricitinib R2|Baricitinib 1 × 4 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
51860|NCT02263911|O3|Outcome|Baricitinib T2|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods.
51861|NCT02263911|O2|Outcome|Baricitinib R1|Baricitinib 1 × 8 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
52064|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
51863|NCT02263911|O5|Outcome|Baricitinib T2F|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD with a low-fat meal on Day 1 in one of five periods.
51864|NCT02263911|O4|Outcome|Baricitinib R2|Baricitinib 1 × 4 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
51865|NCT02263911|O3|Outcome|Baricitinib T2|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods.
51866|NCT02263911|O2|Outcome|Baricitinib R1|Baricitinib 1 × 8 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
51867|NCT02263911|O1|Outcome|Baricitinib T1|Baricitinib 2 × 4 mg commercial formulation tablets administered PO QD in the fasted state on Day 1 in one of five periods.
51868|NCT02263911|O5|Outcome|Baricitinib T2F|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD with a low-fat meal on Day 1 in one of five periods.
51869|NCT02263911|O4|Outcome|Baricitinib R2|Baricitinib 1 × 4 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
51870|NCT02263911|O3|Outcome|Baricitinib T2|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods.
51871|NCT02263911|O2|Outcome|Baricitinib R1|Baricitinib 1 × 8 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
51872|NCT02263911|O1|Outcome|Baricitinib T1|Baricitinib 2 × 4 mg commercial formulation tablets given orally (PO) once daily (QD) in the fasted state on Day 1 in one of five periods.
51873|NCT02263911|E5|Reported Event|Baricitinib T2F|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD with a low-fat meal on Day 1 in one of five periods.
51874|NCT02263911|E4|Reported Event|Baricitinib R2|Baricitinib 1 × 4 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
51875|NCT02263911|E3|Reported Event|Baricitinib T2|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods.
51876|NCT02263911|E2|Reported Event|Baricitinib R1|Baricitinib 1 × 8 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
51877|NCT02263911|E1|Reported Event|Baricitinib T1|Baricitinib 2 × 4 mg commercial formulation tablets administered PO QD in the fasted state on Day 1 in one of five periods.
51878|NCT02263833|B1|Baseline|Overall Participants|Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician’s discretion were observed as per physician’s discretion, approximately up to 4 years.
51879|NCT02263833|P1|Participant Flow|Overall Participants|Participants not previously on erythropoietin-stimulating agent (ESA) therapy and participants on ESA therapy who were prescribed Mircera either subcutaneously (SC) or intravenously (IV) according to local Korean Mircera label and at physician’s discretion were observed as per physician’s discretion, approximately up to 4 years.
51880|NCT02263833|O1|Outcome|Overall Participants|Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician’s discretion were observed as per physician’s discretion, approximately up to 4 years.
51881|NCT02263833|O1|Outcome|Overall Participants|Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician’s discretion were observed as per physician’s discretion, approximately up to 4 years.
51882|NCT02263833|E1|Reported Event|Overall Participants|Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician’s discretion were observed as per physician’s discretion, approximately up to 4 years.
51883|NCT02263365|B3|Baseline|Total|Total of all reporting groups
51884|NCT02263365|B2|Baseline|Therapeutic|"Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered~Loperamide: Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge"
51885|NCT02263365|B1|Baseline|Control|No intervention
51886|NCT02263365|P2|Participant Flow|Therapeutic|"Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered~Loperamide: Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge"
51887|NCT02263365|P1|Participant Flow|Control|No intervention
51888|NCT02263365|O2|Outcome|Therapeutic|"Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered~Loperamide: Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge"
51889|NCT02263365|O1|Outcome|Control|
51890|NCT02263365|O2|Outcome|Therapeutic|"Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered~Loperamide: Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge"
51891|NCT02263365|O1|Outcome|Control|
51892|NCT02263365|O2|Outcome|Therapeutic|"Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered~Loperamide: Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge"
51893|NCT02263365|O1|Outcome|Control|
51894|NCT02263365|O2|Outcome|Therapeutic|"Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered~Loperamide: Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge"
51895|NCT02263365|O1|Outcome|Control|No intervention
51896|NCT02263365|E2|Reported Event|Therapeutic|"Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered~Loperamide: Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge"
51897|NCT02263365|E1|Reported Event|Control|No intervention
51898|NCT02263131|B3|Baseline|Total|Total of all reporting groups
51899|NCT02263131|B2|Baseline|TIV PFS|"VAXIGRIP Prefilled Syringe INJ.~VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL"
51900|NCT02263131|B1|Baseline|IL-YANG PFS|"IL-YANG FLU Vaccine Prefilled Syringe INJ.~IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL"
51901|NCT02263131|P2|Participant Flow|TIV PFS|"VAXIGRIP Prefilled Syringe INJ.~VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL"
51902|NCT02263131|P1|Participant Flow|IL-YANG PFS|"IL-YANG FLU Vaccine Prefilled Syringe INJ.~IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL"
51903|NCT02263131|O2|Outcome|TIV PFS|"VAXIGRIP Prefilled Syringe INJ.~VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL"
51904|NCT02263131|O1|Outcome|IL-YANG PFS|"IL-YANG FLU Vaccine Prefilled Syringe INJ.~IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL"
51905|NCT02263131|O2|Outcome|TIV PFS|"VAXIGRIP Prefilled Syringe INJ.~VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL"
51906|NCT02263131|O1|Outcome|IL-YANG PFS|"IL-YANG FLU Vaccine Prefilled Syringe INJ.~IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL"
51907|NCT02263131|E2|Reported Event|TIV PFS|"VAXIGRIP Prefilled Syringe INJ.~VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL"
51908|NCT02263131|E1|Reported Event|IL-YANG PFS|"IL-YANG FLU Vaccine Prefilled Syringe INJ.~IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL"
51909|NCT02263118|B5|Baseline|Total|Total of all reporting groups
51910|NCT02263118|B4|Baseline|Control Group|"Individuals were given a feature phone (simple mobile phone)~Feature phone: Participants were given a feature phone."
51911|NCT02263118|B3|Baseline|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS~Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
51912|NCT02263118|B2|Baseline|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS"
51913|NCT02263118|B1|Baseline|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone."
51914|NCT02263118|P4|Participant Flow|Control Group|"Individuals were given a feature phone (simple mobile phone)~Feature phone: Participants were given a feature phone."
51915|NCT02263118|P3|Participant Flow|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS~Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
51916|NCT02263118|P2|Participant Flow|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS"
51917|NCT02263118|P1|Participant Flow|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone."
51918|NCT02263118|O4|Outcome|Control Group|"Individuals were given a feature phone (simple mobile phone)~Feature phone: Participants were given a feature phone."
51919|NCT02263118|O3|Outcome|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS~Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
51920|NCT02263118|O2|Outcome|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS"
51921|NCT02263118|O1|Outcome|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone."
51922|NCT02263118|O4|Outcome|Control Group|"There were no virtual communities in this group: individuals were given a feature phone (simple mobile phone)~Feature phone: Participants were given a feature phone."
51923|NCT02263118|O3|Outcome|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS~Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
51924|NCT02263118|O2|Outcome|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS"
51925|NCT02263118|O1|Outcome|Uni-directional SMS|"There were no virtual communities in this group: participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone."
51926|NCT02263118|O4|Outcome|Control Group|"Individuals were given a feature phone (simple mobile phone)~Feature phone: Participants were given a feature phone."
51927|NCT02263118|O3|Outcome|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS~Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
51928|NCT02263118|O2|Outcome|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS"
51929|NCT02263118|O1|Outcome|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone."
51930|NCT02263118|O4|Outcome|Control Group|"Individuals were given a feature phone (simple mobile phone)~Feature phone: Participants were given a feature phone."
51931|NCT02263118|O3|Outcome|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS~Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
51932|NCT02263118|O2|Outcome|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS"
51933|NCT02263118|O1|Outcome|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone."
51934|NCT02263118|E4|Reported Event|Control Group|"Individuals were given a feature phone (simple mobile phone)~Feature phone: Participants were given a feature phone."
51935|NCT02263118|E3|Reported Event|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS~Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
51936|NCT02263118|E2|Reported Event|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS"
51937|NCT02263118|E1|Reported Event|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone."
51938|NCT02262754|B4|Baseline|Total|Total of all reporting groups
51939|NCT02262754|B3|Baseline|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
51940|NCT02262754|B2|Baseline|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
51941|NCT02262754|B1|Baseline|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
51942|NCT02262754|P3|Participant Flow|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
51943|NCT02262754|P2|Participant Flow|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
51944|NCT02262754|P1|Participant Flow|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
51945|NCT02262754|O1|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
51946|NCT02262754|O1|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
51947|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
51948|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
52072|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
51949|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
51950|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
51951|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
51952|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
51953|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
51954|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
51955|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
51956|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
51957|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
51958|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
51959|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
51960|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
51961|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
51962|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
51963|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
51964|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
51965|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
51966|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
51967|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
51968|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
51969|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
51970|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
51971|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
51972|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
51973|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
51974|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
51975|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
51976|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
51977|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
51978|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
51979|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
51980|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
51981|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
51982|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
51983|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
51984|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
51985|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
51986|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
51987|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
51988|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
51989|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
51990|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
51991|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
51992|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
51993|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
51994|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
51995|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
51996|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
51997|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
51998|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
51999|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
52000|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
52001|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
52002|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
52003|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
52004|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
52005|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
52006|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
52007|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
52008|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
52009|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
52010|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
52011|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
52012|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
52013|NCT02262754|E3|Reported Event|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
52014|NCT02262754|E2|Reported Event|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
52015|NCT02262754|E1|Reported Event|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
52016|NCT02262728|B3|Baseline|Total|Total of all reporting groups
52017|NCT02262728|B2|Baseline|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52018|NCT02262728|B1|Baseline|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52019|NCT02262728|P2|Participant Flow|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52020|NCT02262728|P1|Participant Flow|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52021|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52022|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52023|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52024|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52025|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52026|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52027|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52028|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52029|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52030|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52031|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52032|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52033|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52034|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52035|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52065|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
52066|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
52036|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52037|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52038|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52039|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52040|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52041|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52042|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52043|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52044|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52045|NCT02262728|E2|Reported Event|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52046|NCT02262728|E1|Reported Event|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
52047|NCT02262078|B3|Baseline|Total|Total of all reporting groups
52048|NCT02262078|B2|Baseline|Sodium Nitrite|"Participants receive Sodium Nitrite inhalation solution, administered by inhalation over 10-15 minutes, using a nebulizer~Sodium Nitrite Inhalation Solution: 90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise."
52049|NCT02262078|B1|Baseline|Placebo (Saline)|"Participants receive normal saline, administered by inhalation over 10-15 minutes, using a nebulizer~Placebo: Normal saline will be administered (by inhalation) to participants prior to exercise."
52050|NCT02262078|P2|Participant Flow|Sodium Nitrite|"Participants receive Sodium Nitrite inhalation solution, administered by inhalation over 10-15 minutes, using a nebulizer~Sodium Nitrite Inhalation Solution: 90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise."
52051|NCT02262078|P1|Participant Flow|Placebo (Saline)|"Participants receive normal saline, administered by inhalation over 10-15 minutes, using a nebulizer~Placebo: Normal saline will be administered (by inhalation) to participants prior to exercise."
52052|NCT02262078|O2|Outcome|Sodium Nitrite|"Participants receive Sodium Nitrite inhalation solution, administered by inhalation over 10-15 minutes, using a nebulizer~Sodium Nitrite Inhalation Solution: 90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise."
52053|NCT02262078|O1|Outcome|Placebo (Saline)|"Participants receive normal saline, administered by inhalation over 10-15 minutes, using a nebulizer~Placebo: Normal saline will be administered (by inhalation) to participants prior to exercise."
52054|NCT02262078|E2|Reported Event|Sodium Nitrite|"Participants receive Sodium Nitrite inhalation solution, administered by inhalation over 10-15 minutes, using a nebulizer~Sodium Nitrite Inhalation Solution: 90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise."
52055|NCT02262078|E1|Reported Event|Placebo (Saline)|"Participants receive normal saline, administered by inhalation over 10-15 minutes, using a nebulizer~Placebo: Normal saline will be administered (by inhalation) to participants prior to exercise."
52056|NCT02262039|B3|Baseline|Total|Total of all reporting groups
52057|NCT02262039|B2|Baseline|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
52058|NCT02262039|B1|Baseline|Conventional Pressure|15mmHg target pressure
52059|NCT02262039|P2|Participant Flow|Low Pressure (VTI)|"10mmHg target pressure~VTI = Valveless recirculating insufflation"
52060|NCT02262039|P1|Participant Flow|Conventional Pressure|15mmHg target pressure
52061|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
52062|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
52063|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
52073|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
52074|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
52075|NCT02262039|E2|Reported Event|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
52076|NCT02262039|E1|Reported Event|Conventional Pressure|15mmHg target pressure
52077|NCT02261974|B3|Baseline|Total|Total of all reporting groups
52078|NCT02261974|B2|Baseline|Sham Viveve Treatment|"Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus~Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus"
52079|NCT02261974|B1|Baseline|Active Viveve Treatment|"Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus~Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus"
52080|NCT02261974|P2|Participant Flow|Sham Viveve Treatment|"Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus~Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus"
52081|NCT02261974|P1|Participant Flow|Active Viveve Treatment|"Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus~Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus"
52082|NCT02261974|O2|Outcome|Sham Viveve Treatment|"Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus~Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus"
52083|NCT02261974|O1|Outcome|Active Viveve Treatment|"Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus~Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus"
52084|NCT02261974|O2|Outcome|Sham Viveve Treatment|"Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus~Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus"
52085|NCT02261974|O1|Outcome|Active Viveve Treatment|"Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus~Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus"
52086|NCT02261974|O2|Outcome|Sham Viveve Treatment|"Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus~Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus"
52087|NCT02261974|O1|Outcome|Active Viveve Treatment|"Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus~Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus"
52088|NCT02261974|O2|Outcome|Sham Viveve Treatment|"Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus~Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus"
52089|NCT02261974|O1|Outcome|Active Viveve Treatment|"Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus~Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus"
52090|NCT02261974|O2|Outcome|Sham Viveve Treatment|"Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus~Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus"
52091|NCT02261974|O1|Outcome|Active Viveve Treatment|"Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus~Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus"
52092|NCT02261974|E2|Reported Event|Sham Viveve Treatment|"Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus~Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus"
52093|NCT02261974|E1|Reported Event|Active Viveve Treatment|"Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus~Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus"
52094|NCT02261948|B3|Baseline|Total|Total of all reporting groups
52095|NCT02261948|B2|Baseline|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
52096|NCT02261948|B1|Baseline|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
52097|NCT02261948|P2|Participant Flow|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
52098|NCT02261948|P1|Participant Flow|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
52099|NCT02261948|O2|Outcome|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
52100|NCT02261948|O1|Outcome|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
52101|NCT02261948|O2|Outcome|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
52102|NCT02261948|O1|Outcome|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
52103|NCT02261948|O2|Outcome|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
52104|NCT02261948|O1|Outcome|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
52129|NCT02261493|O2|Outcome|OnabotulinumtoxinA Dose B|OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52130|NCT02261493|O1|Outcome|Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.
52105|NCT02261948|E2|Reported Event|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
52106|NCT02261948|E1|Reported Event|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
52107|NCT02261818|B1|Baseline|Meetings With Peer Mentors|"Peer mentors who have experience of depression are trained and supervised to provide social support to older adults to relieve depression. They will provide active listening, empathy, work on a patient-derived goal, psychoeducation and connection to both clinical and community resources.~Meetings with peer mentors: Peer mentors provide social support to address depressive symptoms"
52108|NCT02261818|P1|Participant Flow|Meetings With Peer Mentors|"Peer mentors who have experience of depression are trained and supervised to provide social support to older adults to relieve depression. They will provide active listening, empathy, work on a patient-derived goal, psychoeducation and connection to both clinical and community resources.~Meetings with peer mentors: Peer mentors provide peer support to address depressive symptoms"
52109|NCT02261818|O1|Outcome|Meetings With Peer Mentors|"Peer mentors who have experience of depression are trained and supervised to provide social support to older adults to relieve depression. They will provide active listening, empathy, work on a patient-derived goal, psychoeducation and connection to both clinical and community resources.~Meetings with peer mentors: Peer mentors provide social support to address depressive symptoms"
52110|NCT02261818|E1|Reported Event|Meetings With Peer Mentors|"Peer mentors who have experience of depression are trained and supervised to provide social support to older adults to relieve depression. They will provide active listening, empathy, work on a patient-derived goal, psychoeducation and connection to both clinical and community resources.~Meetings with peer mentors: Peer mentors provide social support to address depressive symptoms"
52111|NCT02261805|B1|Baseline|Ganetespib and Doxorubicin|"Ganetespib 100 or 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle Ganetespib and doxorubicin~Ganetespib and doxorubicin: IV ganetespib and doxorubicin"
52112|NCT02261805|P3|Participant Flow|Ganetespib and Doxorubicin - Phase II Expansion|Ganetespib 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
52113|NCT02261805|P2|Participant Flow|Ganetespib and Doxorubicin - Phase Ib Dose Level 2|Ganetespib 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
52114|NCT02261805|P1|Participant Flow|Ganetespib and Doxorubicin - Phase Ib Dose Level 1|Ganetespib 100 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
52115|NCT02261805|O3|Outcome|Ganetespib and Doxorubicin - Phase II Expansion|Ganetespib 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
52116|NCT02261805|O2|Outcome|Ganetespib and Doxorubicin - Phase Ib Dose Level 2|Ganetespib 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
52117|NCT02261805|O1|Outcome|Ganetespib and Doxorubicin - Phase Ib Dose Level 1|Ganetespib 100 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
52118|NCT02261805|O2|Outcome|Ganetespib and Doxorubicin - Phase Ib Dose Level 2|Ganetespib 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
52119|NCT02261805|O1|Outcome|Ganetespib and Doxorubicin - Phase Ib Dose Level 1|Ganetespib 100 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
52120|NCT02261805|E1|Reported Event|Ganetespib and Doxorubicin|Ganetespib 100 or 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
52121|NCT02261493|B4|Baseline|Total|Total of all reporting groups
52122|NCT02261493|B3|Baseline|OnabotulinumtoxinA Dose A|OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52123|NCT02261493|B2|Baseline|OnabotulinumtoxinA Dose B|OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52124|NCT02261493|B1|Baseline|Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.
52125|NCT02261493|P3|Participant Flow|OnabotulinumtoxinA Dose A|OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52126|NCT02261493|P2|Participant Flow|OnabotulinumtoxinA Dose B|OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52127|NCT02261493|P1|Participant Flow|Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.
52128|NCT02261493|O3|Outcome|OnabotulinumtoxinA Dose A|OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52131|NCT02261493|O3|Outcome|OnabotulinumtoxinA Dose A|OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52132|NCT02261493|O2|Outcome|OnabotulinumtoxinA Dose B|OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52133|NCT02261493|O1|Outcome|Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.
52134|NCT02261493|O3|Outcome|OnabotulinumtoxinA Dose A|OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52135|NCT02261493|O2|Outcome|OnabotulinumtoxinA Dose B|OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52136|NCT02261493|O1|Outcome|Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.
52137|NCT02261493|O3|Outcome|OnabotulinumtoxinA Dose A|OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52138|NCT02261493|O2|Outcome|OnabotulinumtoxinA Dose B|OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52139|NCT02261493|O1|Outcome|Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.
52140|NCT02261493|O3|Outcome|OnabotulinumtoxinA Dose A|OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52141|NCT02261493|O2|Outcome|OnabotulinumtoxinA Dose B|OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52142|NCT02261493|O1|Outcome|Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.
52143|NCT02261493|O3|Outcome|OnabotulinumtoxinA Dose A|OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52144|NCT02261493|O2|Outcome|OnabotulinumtoxinA Dose B|OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52145|NCT02261493|O1|Outcome|Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.
52146|NCT02261493|O3|Outcome|OnabotulinumtoxinA Dose A|OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52147|NCT02261493|O2|Outcome|OnabotulinumtoxinA Dose B|OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52148|NCT02261493|O1|Outcome|Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.
52149|NCT02261493|E3|Reported Event|OnabotulinumtoxinA Dose A|OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52150|NCT02261493|E2|Reported Event|OnabotulinumtoxinA Dose B|OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52151|NCT02261493|E1|Reported Event|Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.
52152|NCT02261467|B3|Baseline|Total|Total of all reporting groups
52153|NCT02261467|B2|Baseline|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52154|NCT02261467|B1|Baseline|Placebo Followed by OnabotulinumtoxinA in Period 2|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
52155|NCT02261467|P2|Participant Flow|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52156|NCT02261467|P1|Participant Flow|Placebo Followed by OnabotulinumtoxinA in Period 2|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
52157|NCT02261467|O2|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52158|NCT02261467|O1|Outcome|Placebo Followed by OnabotulinumtoxinA in Period 2|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
52159|NCT02261467|O2|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52160|NCT02261467|O1|Outcome|Placebo Followed by OnabotulinumtoxinA in Period 2|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
52161|NCT02261467|O2|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52162|NCT02261467|O1|Outcome|Placebo Followed by OnabotulinumtoxinA in Period 2|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
52163|NCT02261467|O2|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52164|NCT02261467|O1|Outcome|Placebo Followed by OnabotulinumtoxinA in Period 2|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
52165|NCT02261467|O2|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52166|NCT02261467|O1|Outcome|Placebo Followed by OnabotulinumtoxinA in Period 2|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
52167|NCT02261467|O2|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52168|NCT02261467|O1|Outcome|Placebo Followed by OnabotulinumtoxinA in Period 2|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
52169|NCT02261467|O2|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52170|NCT02261467|O1|Outcome|Placebo Followed by OnabotulinumtoxinA in Period 2|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
52171|NCT02261467|E2|Reported Event|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
52172|NCT02261467|E1|Reported Event|Placebo Followed by OnabotulinumtoxinA in Period 2|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
52173|NCT02261428|B3|Baseline|Total|Total of all reporting groups
52174|NCT02261428|B2|Baseline|Suction Catheter First, Then Catheter Tiemann|Participants first received nasotracheal suction with Suction catheter . After a washout period minimum of half hour they received a second nasotracheal suction with catheter Tiemann.
52175|NCT02261428|B1|Baseline|Catheter Tiemann First, Then Suction Catheter|Participants first received nasotracheal suction with catheter Tiemann. After a washout period minimum of half hour they received a second nasotracheal suction with Suction catheter
52176|NCT02261428|P2|Participant Flow|Suction Catheter First, Then Catheter Tiemann|Participants first received nasotracheal suction with suction catheter. After a washout period minimum of half hour they received a second nasotracheal suction with catheter Tiemann.
52177|NCT02261428|P1|Participant Flow|Catheter Tiemann First, Then Suction Catheter|Participants first received nasotracheal suction with catheter Tiemann. After a washout period minimum of half hour they received a second nasotracheal suction with Suction catheter
52178|NCT02261428|O2|Outcome|Suction Catheter|Presence of blood was found on Participants immediately after suctioning with Suction catheter
52179|NCT02261428|O1|Outcome|Catheter Tiemann|Presence of blood was found on Participants immediately after suctioning with catheter Tiemann
52180|NCT02261428|O2|Outcome|Suction Catheter|The number below represents the mean of diastolic blood pressure recorded immediately after insertion to trachea wth Suction catheter
52181|NCT02261428|O1|Outcome|Catheter Tiemann|The number below represents the mean of diastolic blood pressure recorded immediately after insertion to trachea wth catheter Tiemann.
52182|NCT02261428|O2|Outcome|Suction Catheter|The number below represents the mean of systolic blood pressure recorded immediately after insertion to trachea wth Suction catheter
52183|NCT02261428|O1|Outcome|Catheter Tiemann|The number below represents the mean of systolic blood pressure recorded immediately after insertion to trachea wth catheter Tiemann.
52184|NCT02261428|O2|Outcome|Suction Catheter|The number below represents the mean of heart rate recorded immediately after insertion to trachea wth Suction catheter
52185|NCT02261428|O1|Outcome|Catheter Tiemann|The number below represents the mean of heart rate recorded immediately after insertion to trachea wth catheter Tiemann.
52186|NCT02261428|O2|Outcome|Suction Catheter|The number below represents the mean of respiratory rate recorded immediately after insertion to trachea wth Suction catheter
52187|NCT02261428|O1|Outcome|Catheter Tiemann|The number below represents the mean of respiratory rate recorded immediately after insertion to trachea wth catheter Tiemann.
52188|NCT02261428|O2|Outcome|Suction Catheter|The number below represents the mean of time required to insert the trachea wth Suction catheter
52189|NCT02261428|O1|Outcome|Catheter Tiemann|The number below represents the mean of time required to insert the trachea wth catheter Tiemann.
52190|NCT02261428|O2|Outcome|Suction Catheter|The number below represents the mean of attempts made wth Suction catheter.
52191|NCT02261428|O1|Outcome|Catheter Tiemann|The number below represents the mean of attempts made wth catheter Tiemann.
52192|NCT02261428|E2|Reported Event|Suction Catheter|Participants received nasotracheal suction with Suction catheter
52193|NCT02261428|E1|Reported Event|Catheter Tiemann|Participants received nasotracheal suction with catheter Tiemann.
52194|NCT02260986|B4|Baseline|Total|Total of all reporting groups
52195|NCT02260986|B3|Baseline|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
53723|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
52196|NCT02260986|B2|Baseline|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52197|NCT02260986|B1|Baseline|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52198|NCT02260986|P3|Participant Flow|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52199|NCT02260986|P2|Participant Flow|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52200|NCT02260986|P1|Participant Flow|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52201|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52202|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52203|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52204|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52205|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52206|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52207|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.
52208|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.
52209|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52210|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.
52211|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.
52212|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52213|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.
52214|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.
52215|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52216|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.
52217|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.
52218|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52219|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.
52220|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.
52221|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52222|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.
52223|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.
52224|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52225|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52226|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52227|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52228|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52229|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52230|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52231|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52232|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52233|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52234|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52235|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52236|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52237|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52238|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52239|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52240|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52241|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52242|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52243|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52244|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52245|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52246|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52247|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52248|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52249|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52250|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52251|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52252|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52253|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52254|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52255|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52256|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52257|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52258|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52259|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52260|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52261|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52262|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52263|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52264|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52265|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52266|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52267|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52268|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52269|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52270|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52271|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52272|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52273|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52274|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52275|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52276|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52277|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52278|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52279|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52280|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52281|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52282|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52283|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52284|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52285|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52286|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52287|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52288|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52289|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52290|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52291|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52292|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52293|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52294|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52295|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52296|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52297|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52298|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52299|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52300|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52301|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52302|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52374|NCT02260791|O1|Outcome|FKB327|Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
52303|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52304|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52305|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52306|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52307|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51.
52308|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52309|NCT02260986|O3|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
52310|NCT02260986|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
52311|NCT02260986|O1|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51
52312|NCT02260986|E3|Reported Event|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.
52313|NCT02260986|E2|Reported Event|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.
52314|NCT02260986|E1|Reported Event|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
52315|NCT02260882|B3|Baseline|Total|Total of all reporting groups
52316|NCT02260882|B2|Baseline|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
52317|NCT02260882|B1|Baseline|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
52318|NCT02260882|P2|Participant Flow|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
52319|NCT02260882|P1|Participant Flow|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
52320|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
52321|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
52322|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
52323|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
52324|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
52325|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
52326|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
52327|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
52328|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
52329|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
52330|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
52331|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
52332|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
52333|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
52334|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
52335|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
52336|NCT02260882|O1|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
52337|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
52338|NCT02260882|E2|Reported Event|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
52339|NCT02260882|E1|Reported Event|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
52340|NCT02260791|B3|Baseline|Total|Total of all reporting groups
52341|NCT02260791|B2|Baseline|Humira®|Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
52342|NCT02260791|B1|Baseline|FKB327|Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
52343|NCT02260791|P2|Participant Flow|Humira®|Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
52344|NCT02260791|P1|Participant Flow|FKB327|Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
52345|NCT02260791|O2|Outcome|Humira®|Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
52346|NCT02260791|O1|Outcome|FKB327|Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
52347|NCT02260791|O2|Outcome|Humira®|Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
52348|NCT02260791|O1|Outcome|FKB327|Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
52349|NCT02260791|O2|Outcome|Humira®|Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
52350|NCT02260791|O1|Outcome|FKB327|Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
52351|NCT02260791|O2|Outcome|Humira®|Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
52352|NCT02260791|O1|Outcome|FKB327|Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
52353|NCT02260791|O2|Outcome|Humira®|Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
52354|NCT02260791|O1|Outcome|FKB327|Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
52355|NCT02260791|O2|Outcome|Humira®|Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
52356|NCT02260791|O1|Outcome|FKB327|Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
52357|NCT02260791|O2|Outcome|Humira®|Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
52358|NCT02260791|O1|Outcome|FKB327|Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
52359|NCT02260791|O2|Outcome|Humira®|Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
52360|NCT02260791|O1|Outcome|FKB327|Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
52361|NCT02260791|O2|Outcome|Humira®|Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
52362|NCT02260791|O1|Outcome|FKB327|Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
52363|NCT02260791|O2|Outcome|Humira®|Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
52364|NCT02260791|O1|Outcome|FKB327|Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
52365|NCT02260791|O2|Outcome|Humira®|Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
52366|NCT02260791|O1|Outcome|FKB327|Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
52367|NCT02260791|O2|Outcome|Humira®|Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
52368|NCT02260791|O1|Outcome|FKB327|Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
52369|NCT02260791|O2|Outcome|Humira®|Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
52370|NCT02260791|O1|Outcome|FKB327|Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
52371|NCT02260791|O2|Outcome|Humira®|Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
52372|NCT02260791|O1|Outcome|FKB327|Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
52373|NCT02260791|O2|Outcome|Humira®|Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
53724|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
52375|NCT02260791|O2|Outcome|Humira®|Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
52376|NCT02260791|O1|Outcome|FKB327|Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
52377|NCT02260791|E2|Reported Event|Humira®|Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
52378|NCT02260791|E1|Reported Event|FKB327|Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
52379|NCT02260492|B4|Baseline|Total|Total of all reporting groups
52380|NCT02260492|B3|Baseline|Placebo|"Placebo (twice daily inhalation throughout the study)~Placebo: Placebo (lactose) administered via the Solis dry powder inhaler"
52381|NCT02260492|B2|Baseline|Advair Diskus|"Advair Diskus (twice daily inhalation throughout the study)~Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler"
52382|NCT02260492|B1|Baseline|OT329 Solis|"OT329 Solis (twice daily inhalation throughout the study)~OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler"
52383|NCT02260492|P3|Participant Flow|Placebo|"Placebo (twice daily inhalation throughout the study)~Placebo: Placebo (lactose) administered via the Solis dry powder inhaler"
52384|NCT02260492|P2|Participant Flow|Advair Diskus|"Advair Diskus (twice daily inhalation throughout the study)~Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler"
52385|NCT02260492|P1|Participant Flow|OT329 Solis|"OT329 Solis (twice daily inhalation throughout the study)~OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler"
52386|NCT02260492|O3|Outcome|Placebo|"Placebo (twice daily inhalation throughout the study)~Placebo: Placebo (lactose) administered via the Solis dry powder inhaler"
52387|NCT02260492|O2|Outcome|Advair Diskus|"Advair Diskus (twice daily inhalation throughout the study)~Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler"
52388|NCT02260492|O1|Outcome|OT329 Solis|"OT329 Solis (twice daily inhalation throughout the study)~OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler"
52389|NCT02260492|O3|Outcome|Placebo|"Placebo (twice daily inhalation throughout the study)~Placebo: Placebo (lactose) administered via the Solis dry powder inhaler"
52390|NCT02260492|O2|Outcome|Advair Diskus|"Advair Diskus (twice daily inhalation throughout the study)~Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler"
52391|NCT02260492|O1|Outcome|OT329 Solis|"OT329 Solis (twice daily inhalation throughout the study)~OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler"
52392|NCT02260492|O3|Outcome|Placebo|"Placebo (twice daily inhalation throughout the study)~Placebo: Placebo (lactose) administered via the Solis dry powder inhaler"
52393|NCT02260492|O2|Outcome|Advair Diskus|"Advair Diskus (twice daily inhalation throughout the study)~Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler"
52394|NCT02260492|O1|Outcome|OT329 Solis|"OT329 Solis (twice daily inhalation throughout the study)~OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler"
52395|NCT02260492|E3|Reported Event|Placebo|"Placebo (twice daily inhalation throughout the study)~Placebo: Placebo (lactose) administered via the Solis dry powder inhaler"
52396|NCT02260492|E2|Reported Event|Advair Diskus|"Advair Diskus (twice daily inhalation throughout the study)~Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler"
52397|NCT02260492|E1|Reported Event|OT329 Solis|"OT329 Solis (twice daily inhalation throughout the study)~OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler"
52398|NCT02260440|B1|Baseline|Pembrolizumab and Azacitidine|"200 mg of Pembrolizumab was administered intravenously over 30 minutes on Day 1 of every 21 day cycle. 100 mg of Azacitidine was given daily via subcutaneous injection on days 1-5 every 21 days.~Treatment continued for 9 cycles (about 27 weeks) or until there was an evidence of progression of disease (PD) or unacceptable toxicity before the completion of the planned 9 cycles."
52399|NCT02260440|P1|Participant Flow|Pembrolizumab and Azacitidine|"200 mg of Pembrolizumab was administered intravenously over 30 minutes on Day 1 of every 21 day cycle. 100 mg of Azacitidine was given daily via subcutaneous injection on days 1-5 every 21 days.~Treatment continued for 9 cycles (about 27 weeks) or until there was an evidence of progression of disease (PD) or unacceptable toxicity before the completion of the planned 9 cycles."
52400|NCT02260440|O1|Outcome|Pembrolizumab and Azacitidine|"200 mg of Pembrolizumab was administered intravenously over 30 minutes on Day 1 of every 21 day cycle. 100 mg of Azacitidine was given daily via subcutaneous injection on days 1-5 every 21 days.~Treatment continued for 9 cycles (about 27 weeks) or until there was an evidence of progression of disease (PD) or unacceptable toxicity before the completion of the planned 9 cycles."
52401|NCT02260440|O1|Outcome|Pembrolizumab and Azacitidine|"200 mg of Pembrolizumab was administered intravenously over 30 minutes on Day 1 of every 21 day cycle. 100 mg of Azacitidine was given daily via subcutaneous injection on days 1-5 every 21 days.~Treatment continued for 9 cycles (about 27 weeks) or until there was an evidence of progression of disease (PD) or unacceptable toxicity before the completion of the planned 9 cycles."
52468|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
52402|NCT02260440|O1|Outcome|Pembrolizumab and Azacitidine|"200 mg of Pembrolizumab was administered intravenously over 30 minutes on Day 1 of every 21 day cycle. 100 mg of Azacitidine was given daily via subcutaneous injection on days 1-5 every 21 days.~Treatment continued for 9 cycles (about 27 weeks) or until there was an evidence of progression of disease (PD) or unacceptable toxicity before the completion of the planned 9 cycles."
52403|NCT02260440|E1|Reported Event|Pembrolizumab and Azacitidine|"200 mg of Pembrolizumab was administered intravenously over 30 minutes on Day 1 of every 21 day cycle. 100 mg of Azacitidine was given daily via subcutaneous injection on days 1-5 every 21 days.~Treatment continued for 9 cycles (about 27 weeks) or until there was an evidence of progression of disease (PD) or unacceptable toxicity before the completion of the planned 9 cycles."
52404|NCT02260401|B3|Baseline|Total|Total of all reporting groups
52405|NCT02260401|B2|Baseline|Individualized Reports After 24 Months|Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.
52406|NCT02260401|B1|Baseline|Individualized Report|"Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.~Individualized report: Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)"
52407|NCT02260401|P2|Participant Flow|Individualized Reports After 24 Months|Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.
52408|NCT02260401|P1|Participant Flow|Individualized Report|"Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.~Individualized report: Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)"
52409|NCT02260401|O2|Outcome|Individualized Reports After 24 Months|Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.
52410|NCT02260401|O1|Outcome|Individualized Report|"Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.~Individualized report: Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)"
52411|NCT02260401|E2|Reported Event|Individualized Reports After 24 Months|Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.
52412|NCT02260401|E1|Reported Event|Individualized Report|"Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.~Individualized report: Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)"
52413|NCT02259608|B1|Baseline|yBCG|15 healthy volunteers that receive yBCG at baseline. There is no control group included in this trial.
52414|NCT02259608|P1|Participant Flow|BCG Vaccine SSI|"Healthy volunteers are vaccinated with yBCG. Blood will be drawn before and at several timepoints after vaccination. Cytokine production before vaccination will be used as reference to compare later timepoints with.~BCG vaccine SSI: BCG vaccination"
52415|NCT02259608|O1|Outcome|BCG Vaccine SSI|"Healthy volunteers are vaccinated with yBCG. Blood will be drawn before and at several timepoints after vaccination. Cytokine production before vaccination will be used as reference to compare later timepoints with.~BCG vaccine SSI: BCG vaccination"
52416|NCT02259608|O1|Outcome|BCG Vaccine SSI|"Healthy volunteers are vaccinated with yBCG. Blood will be drawn before and at several timepoints after vaccination. Cytokine production before vaccination will be used as reference to compare later timepoints with.~BCG vaccine SSI: BCG vaccination"
52417|NCT02259608|E1|Reported Event|BCG Vaccine SSI|"Healthy volunteers are vaccinated with yBCG. Blood will be drawn before and at several timepoints after vaccination. Cytokine production before vaccination will be used as reference to compare later timepoints with.~BCG vaccine SSI: BCG vaccination"
52418|NCT02259400|B3|Baseline|Total|Total of all reporting groups
52419|NCT02259400|B2|Baseline|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
52420|NCT02259400|B1|Baseline|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
52469|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
52421|NCT02259400|P2|Participant Flow|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
52422|NCT02259400|P1|Participant Flow|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
52423|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
52424|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
52425|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
52426|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
52427|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
52470|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
52471|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
52472|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
52428|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
52429|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
52430|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
52431|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
52432|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
52433|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
52434|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
52473|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
52474|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
52475|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
52435|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
52436|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
52437|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
52438|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
52439|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
52440|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
52441|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
52476|NCT02258529|E1|Reported Event|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
52479|NCT02258477|P3|Participant Flow|Sequence 3 (C-A-B-D)|Subjects in sequence 3 received 50 calorie beverage in week 1, 0 calorie control beverage in week 2, 20 calorie beverage in week 3, and 100 calorie beverage in week 4.
52480|NCT02258477|P2|Participant Flow|Sequence 2 (A-D-C-B)|Subjects in sequence 2 received 0 calorie control beverage in week 1, 100 calorie beverage in week 2, 50 calorie beverage in week 3, and 10 calorie beverage in week 4.
52442|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
52443|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
52444|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
52445|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
52446|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
52447|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
52448|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
52477|NCT02258477|B1|Baseline|All Study Subjects|"Compare the efficacy of 0 calorie sucralose-sweetened water on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Glucose: This is a randomized, double-blind cross-over pilot study involving 40 study subjects. We will compare the efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food. After baseline data collection, eligible participants will be randomized into one of the four sequence group and receive a different beverage each week."
52449|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
52450|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
52451|NCT02259400|E2|Reported Event|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
52452|NCT02259400|E1|Reported Event|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
52453|NCT02259348|B1|Baseline|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
52454|NCT02259348|P1|Participant Flow|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
52455|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
52456|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
52478|NCT02258477|P4|Participant Flow|Sequence 4 (B-C-D-A)|Subjects in sequence 4 received 10 calorie beverage in week 1, 50 calorie beverage in week 2, 100 calorie beverage in week 3, and 0 calorie control beverage in week 4.
84000|NCT02061358|B1|Baseline|3 mg UV-4B|UV-4B 3 mg oral, single dose
52457|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
52458|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
52459|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
52460|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
52461|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
52462|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
52463|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
52464|NCT02259348|E1|Reported Event|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
52465|NCT02258529|B1|Baseline|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
52466|NCT02258529|P1|Participant Flow|Idelalisib + Rituximab|Idelalisib (Zydelig®) 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
52467|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
52526|NCT02258334|O2|Outcome|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal of Fluzone Intradermal vaccine.
52481|NCT02258477|P1|Participant Flow|Sequence 1 (D-B-A-C)|Subjects assigned to sequence 1 received 100 calorie beverage in week 1, 10 calorie beverage in week 2, 0 calorie control beverage in week 3, and 50 calorie beverage in week 4.
52482|NCT02258477|O4|Outcome|10 cal Glucose Beverage|"Compare the efficacy of a 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
52483|NCT02258477|O3|Outcome|50 cal Glucose Beverage|"Compare the efficacy of a 50 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
52484|NCT02258477|O2|Outcome|100 Calorie Glucose Beverage|"Compare the efficacy of a 100 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence group and receive each treatment for 1 week."
52485|NCT02258477|O1|Outcome|Control|"Compare the efficacy of 0 calorie sucralose-sweetened water on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
52486|NCT02258477|O4|Outcome|10 cal Glucose Beverage|"Compare the efficacy of a 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
52487|NCT02258477|O3|Outcome|50 cal Glucose Beverage|"Compare the efficacy of a 50 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
52488|NCT02258477|O2|Outcome|100 Calorie Glucose Beverage|"Compare the efficacy of a 100 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence group and receive each treatment for 1 week."
52489|NCT02258477|O1|Outcome|Control|"Compare the efficacy of 0 calorie sucralose-sweetened water on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
52490|NCT02258477|O4|Outcome|10 Calorie|"Compare the efficacy of a 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
52491|NCT02258477|O3|Outcome|50 Calorie Beverage|"Compare the efficacy of a 50 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
52492|NCT02258477|O2|Outcome|100 Calorie Glucose Beverage|"Compare the efficacy of a 100 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence group and receive each treatment for 1 week."
84001|NCT02061358|P9|Participant Flow|Placebo|Placebo oral, single dose
52493|NCT02258477|O1|Outcome|Control|"Compare the efficacy of 0 calorie sucralose-sweetened water on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
52494|NCT02258477|E1|Reported Event|All Study Subjects|Subjects were randomized into four possible sequences: subjects assigned to sequence 1 received the control beverage first during week 1, then the 10 calorie beverage during week 2, then the 50 calorie beverage during week 3, and then the 100 calorie beverage during week 4. Subjects assigned to sequence 2 received received the 50 calorie beverage during week 1, then the 100 calorie beverage during week 2, then the control beverage during week 3, and then the 50 calorie beverage during week 4. Subejcts assigned to sequence 3 received the 50 calorie beverage during week 1, then the control beverage during week 2, then the 100 calorie beverage during week 3, and then the 10 calorie beverage during week 4. Subjects assigned to sequence 4 received the 100 calorie beverage during week 1, then the 50 calorie beverage during week 2, then the 10 calorie beverage during week 3, and then the control beverage during week 4.
52495|NCT02258412|B4|Baseline|Total|Total of all reporting groups
52496|NCT02258412|B3|Baseline|Patient|Patients received no treatment, but were cared for by healthcare workers who enrolled in the study
52497|NCT02258412|B2|Baseline|Alcohol Only First|Healthcare workers who received product with alcohol only prior to product with alcohol + CHG
52498|NCT02258412|B1|Baseline|Alcohol + CHG First|Healthcare workers who received product with alcohol + CHG prior to product with alcohol only
52499|NCT02258412|P3|Participant Flow|Patient|Patients received no treatment, but were cared for by healthcare workers who enrolled in the study
52500|NCT02258412|P2|Participant Flow|Alcohol Only First|Healthcare workers who received product with alcohol only prior to product with alcohol + CHG
52501|NCT02258412|P1|Participant Flow|Alcohol + CHG First|Healthcare workers who received product with alcohol + CHG prior to product with alcohol only
52502|NCT02258412|O2|Outcome|Hand Antiseptic With CHG and Alcohol|"Hand antiseptic is applied by dispensing 1 pump into hands, spreading over the hands up to the wrist, and rubbing until dry. Hand antiseptic will be used twice approximately 15-30 minutes apart on one day.~hand antiseptic with CHG and alcohol: HCWs will be randomized to use one product on one day and the other product on another day at least 3 days apart. Each product will be applied using 1 pump from its dispenser and rubbed over the hands until dry. Gloves will be worn while the HCW is in the patient room. Upon exit from the room, HCW will washoout with that same product. One imprint will be made of the non-dominant hand onto media containing neutralizers. That hand will be gloved with a white cotton glove. The HCW will work in the common areas with timing recorded. Upon leaving the common area, the dominant ungloved hand will be imprinted onto a fresh media plate containing neutralizers."
52503|NCT02258412|O1|Outcome|Alcohol Hand Sanitizer Foam|"Alcohol foam hand sanitizer applied with 1 pump into hands, spread over hands up to the wrist and rubbed until dry. Foam will be applied twice approximately 15-30 minutes apart on one day.~Alcohol hand sanitizer foam: Alcohol foam hand sanitizer applied with 1 pump into hands, spread over hands up to the wrist and rubbed until dry. Foam will be applied twice approximately 15-30 minutes apart on one day"
52504|NCT02258412|E3|Reported Event|Patient|Patients received no treatment, but were cared for by healthcare workers who enrolled in the study
52505|NCT02258412|E2|Reported Event|Alcohol Only First|Healthcare workers who received product with alcohol only prior to product with alcohol + CHG
52506|NCT02258412|E1|Reported Event|Alcohol + CHG First|Healthcare workers who received product with alcohol + CHG prior to product with alcohol only
52507|NCT02258334|B5|Baseline|Total|Total of all reporting groups
52508|NCT02258334|B4|Baseline|Group 4|Adults ≥ 65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
52509|NCT02258334|B3|Baseline|Group 3|Adults ≥ 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
52510|NCT02258334|B2|Baseline|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
52511|NCT02258334|B1|Baseline|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
52512|NCT02258334|P4|Participant Flow|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
52513|NCT02258334|P3|Participant Flow|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
52514|NCT02258334|P2|Participant Flow|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
52515|NCT02258334|P1|Participant Flow|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
52516|NCT02258334|O4|Outcome|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine.
52517|NCT02258334|O3|Outcome|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
52518|NCT02258334|O2|Outcome|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
52519|NCT02258334|O1|Outcome|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
52520|NCT02258334|O4|Outcome|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine.
52521|NCT02258334|O3|Outcome|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
52522|NCT02258334|O2|Outcome|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
52523|NCT02258334|O1|Outcome|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
52524|NCT02258334|O4|Outcome|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
52525|NCT02258334|O3|Outcome|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
52527|NCT02258334|O1|Outcome|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
52528|NCT02258334|O4|Outcome|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
52529|NCT02258334|O3|Outcome|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
52530|NCT02258334|O2|Outcome|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
52531|NCT02258334|O1|Outcome|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
52532|NCT02258334|O4|Outcome|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
52533|NCT02258334|O3|Outcome|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
52534|NCT02258334|O2|Outcome|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
52535|NCT02258334|O1|Outcome|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
52536|NCT02258334|E4|Reported Event|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine.
52537|NCT02258334|E3|Reported Event|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
52538|NCT02258334|E2|Reported Event|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
52539|NCT02258334|E1|Reported Event|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
52540|NCT02257918|B4|Baseline|Total|Total of all reporting groups
52541|NCT02257918|B3|Baseline|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
52542|NCT02257918|B2|Baseline|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
52543|NCT02257918|B1|Baseline|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
52544|NCT02257918|P3|Participant Flow|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
52545|NCT02257918|P2|Participant Flow|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
52546|NCT02257918|P1|Participant Flow|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
52547|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
52548|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
52549|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
52550|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
52551|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
52552|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
52553|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
52554|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
52555|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
52556|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
52557|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
52558|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
52559|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
52560|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
52561|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
52562|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
52563|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
52564|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
52565|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
52566|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
52567|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
52568|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
52569|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
52570|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
52571|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
52572|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
52573|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
52574|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
52575|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
52576|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
52577|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
52578|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
52579|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
52580|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
52581|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
52582|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
52583|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
52584|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
52585|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
52586|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
52587|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
52588|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
52589|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
52590|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
52591|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
52592|NCT02257918|E3|Reported Event|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
52593|NCT02257918|E2|Reported Event|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
52594|NCT02257918|E1|Reported Event|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
52595|NCT02257684|B1|Baseline|Pegcrisantaspase|pegcrisantaspase
52596|NCT02257684|P1|Participant Flow|Pegcrisantaspase|IV administration of pegcrisantaspase in Course 1
52597|NCT02257684|O1|Outcome|Pegcrisantaspase|IV administration of pegcrisantaspase in Course 1
52598|NCT02257684|O1|Outcome|Pegcrisantaspase|IV administration of pegcrisantaspase in Course 1
52599|NCT02257684|O1|Outcome|Pegcrisantaspase|IV administration of pegcrisantaspase in Course 1
52600|NCT02257684|O1|Outcome|Pegcrisantaspase|IV administration of pegcrisantaspase in Course 1
52601|NCT02257684|O1|Outcome|Pegcrisantaspase|IV administration of pegcrisantaspase in Course 1
52602|NCT02257684|E1|Reported Event|Pegcrisantaspase|IV administration of pegcrisantaspase in Course 1
52603|NCT02257385|B3|Baseline|Total|Total of all reporting groups
52604|NCT02257385|B2|Baseline|Indacaterol 150 µg + Tiotropium Bromide 18 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing placebo, BREEZHALER containing indacaterol 150 µg, and HANDIHALER containing tiotropium bromide 18 µg. The inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
52605|NCT02257385|B1|Baseline|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg), BREEZHALER containing placebo, and HANDIHALER containing placebo. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
52606|NCT02257385|P2|Participant Flow|Indacaterol 150 µg + Tiotropium Bromide 18 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing placebo, BREEZHALER containing indacaterol 150 µg, and HANDIHALER containing tiotropium bromide 18 µg. The inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
52607|NCT02257385|P1|Participant Flow|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg), BREEZHALER containing placebo, and HANDIHALER containing placebo. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
52608|NCT02257385|O2|Outcome|Indacaterol 150 µg + Tiotropium Bromide 18 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing placebo, BREEZHALER containing indacaterol 150 µg, and HANDIHALER containing tiotropium bromide 18 µg. The inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
52609|NCT02257385|O1|Outcome|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg), BREEZHALER containing placebo, and HANDIHALER containing placebo. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
52610|NCT02257385|O2|Outcome|Indacaterol 150 µg + Tiotropium Bromide 18 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing placebo, BREEZHALER containing indacaterol 150 µg, and HANDIHALER containing tiotropium bromide 18 µg. The inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
52611|NCT02257385|O1|Outcome|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg), BREEZHALER containing placebo, and HANDIHALER containing placebo. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
52612|NCT02257385|E2|Reported Event|Indacaterol 150 µg + Tiotropium Bromide 18 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing placebo, BREEZHALER containing indacaterol 150 µg, and HANDIHALER containing tiotropium bromide 18 µg. The inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
52723|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
84022|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
52613|NCT02257385|E1|Reported Event|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg), BREEZHALER containing placebo, and HANDIHALER containing placebo. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
52614|NCT02257372|B3|Baseline|Total|Total of all reporting groups
52615|NCT02257372|B2|Baseline|Umeclidinium 62.5 mcg+ICS/LABA|Participants received Umeclidinium 62.5 microgram(mcg) via a DPI once daily and an open-label ICS/LABA administered according to label instructions for 12 weeks. Participants also received albuterol/salbutamol via a MDI or nebules as rescue medication throughout the study for use as needed.
52616|NCT02257372|B1|Baseline|Placebo+ICS/LABA|Participants received double-blind placebo via a dry powder inhaler (DPI) once daily and an open-label inhaled corticosteriod (ICS)/Long-acting beta2-agonist(LABA) administered according to the label instructions for 12 weeks. Participants also received albuterol/salbutamol via a metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
52617|NCT02257372|P2|Participant Flow|Umeclidinium 62.5 mcg+ICS/LABA|Participants received Umeclidinium 62.5 microgram(mcg) via a DPI once daily and an open-label ICS/LABA administered according to label instructions for 12 weeks. Participants also received albuterol/salbutamol via a MDI or nebules as rescue medication throughout the study for use as needed.
52618|NCT02257372|P1|Participant Flow|Placebo+ICS/LABA|Participants received double-blind placebo via a dry powder inhaler (DPI) once daily and an open-label inhaled corticosteriod (ICS)/Long-acting beta2-agonist(LABA) administered according to the label instructions for 12 weeks. Participants also received albuterol/salbutamol via a metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
52619|NCT02257372|O2|Outcome|Umeclidinium 62.5 mcg+ICS/LABA|Participants received Umeclidinium 62.5 microgram(mcg) via a DPI once daily and an open-label ICS/LABA administered according to label instructions for 12 weeks. Participants also received albuterol/salbutamol via a MDI or nebules as rescue medication throughout the study for use as needed
52620|NCT02257372|O1|Outcome|Placebo+ICS/LABA|Participants received double-blind placebo via a dry powder inhaler (DPI) once daily and an open-label inhaled corticosteriod (ICS)/Long-acting beta2-agonist(LABA) administered according to the label instructions for 12 weeks. Participants also received albuterol/salbutamol via a metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
52621|NCT02257372|O2|Outcome|Umeclidinium 62.5 mcg+ICS/LABA|Participants received Umeclidinium 62.5 microgram(mcg) via a DPI once daily and an open-label ICS/LABA administered according to label instructions for 12 weeks. Participants also received albuterol/salbutamol via a MDI or nebules as rescue medication throughout the study for use as needed
52622|NCT02257372|O1|Outcome|Placebo+ICS/LABA|Participants received double-blind placebo via a dry powder inhaler (DPI) once daily and an open-label inhaled corticosteriod (ICS)/Long-acting beta2-agonist(LABA) administered according to the label instructions for 12 weeks. Participants also received albuterol/salbutamol via a metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
52623|NCT02257372|E2|Reported Event|Umeclidinium 62.5 mcg+ICS/LABA|Participants received Umeclidinium 62.5 microgram(mcg) via a DPI once daily and an open-label ICS/LABA administered according to label instructions for 12 weeks. Participants also received albuterol/salbutamol via a MDI or nebules as rescue medication throughout the study for use as needed.
52624|NCT02257372|E1|Reported Event|Placebo+ICS/LABA|Participants received double-blind placebo via a dry powder inhaler (DPI) once daily and an open-label inhaled corticosteriod (ICS)/Long-acting beta2-agonist(LABA) administered according to the label instructions for 12 weeks. Participants also received albuterol/salbutamol via a metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed
52625|NCT02256982|B3|Baseline|Total|Total of all reporting groups
52626|NCT02256982|B2|Baseline|Unresectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to radiation therapy with protons or photons, determined by available resources~Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist~Gemcitabine~Cisplatin~Radiation: Radiation Therapy"
52627|NCT02256982|B1|Baseline|Resectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to surgery~Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist~Gemcitabine~Cisplatin~Surgery: Surgical Resection and Lymphadenectomy"
52628|NCT02256982|P2|Participant Flow|Unresectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to radiation therapy with protons or photons, determined by available resources~Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist~Gemcitabine~Cisplatin~Radiation: Radiation Therapy"
52629|NCT02256982|P1|Participant Flow|Resectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to surgery~Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist~Gemcitabine~Cisplatin~Surgery: Surgical Resection and Lymphadenectomy"
52630|NCT02256982|O2|Outcome|Unresectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to radiation therapy with protons or photons, determined by available resources~Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist~Gemcitabine~Cisplatin~Radiation: Radiation Therapy"
52724|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
52631|NCT02256982|O1|Outcome|Resectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to surgery~Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist~Gemcitabine~Cisplatin~Surgery: Surgical Resection and Lymphadenectomy"
52632|NCT02256982|E2|Reported Event|Unresectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to radiation therapy with protons or photons, determined by available resources~Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist~Gemcitabine~Cisplatin~Radiation: Radiation Therapy"
52633|NCT02256982|E1|Reported Event|Resectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to surgery~Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist~Gemcitabine~Cisplatin~Surgery: Surgical Resection and Lymphadenectomy"
52634|NCT02256969|B4|Baseline|Total|Total of all reporting groups
52635|NCT02256969|B3|Baseline|Meibomian Gland Probing Plus Blephamide|"Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.~Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks."
52636|NCT02256969|B2|Baseline|Sham Meibomian Gland Probing Plus Lubricant|"Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.~Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
52637|NCT02256969|B1|Baseline|Meibomian Gland Probing Plus Lubricant|"Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.~Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
52638|NCT02256969|P3|Participant Flow|Meibomian Gland Probing Plus Blephamide|"Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.~Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks."
52639|NCT02256969|P2|Participant Flow|Sham Meibomian Gland Probing Plus Lubricant|"Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.~Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
52640|NCT02256969|P1|Participant Flow|Meibomian Gland Probing Plus Lubricant|"Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.~Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
52641|NCT02256969|O3|Outcome|Meibomian Gland Probing Plus Blephamide|"Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.~Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks."
52642|NCT02256969|O2|Outcome|Sham Meibomian Gland Probing Plus Lubricant|"Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.~Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
52643|NCT02256969|O1|Outcome|Meibomian Gland Probing Plus Lubricant|"Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.~Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
52644|NCT02256969|O3|Outcome|Meibomian Gland Probing Plus Blephamide|"Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.~Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks."
52645|NCT02256969|O2|Outcome|Sham Meibomian Gland Probing Plus Lubricant|"Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.~Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
52646|NCT02256969|O1|Outcome|Meibomian Gland Probing Plus Lubricant|"Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.~Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
52725|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
53725|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
52647|NCT02256969|O3|Outcome|Meibomian Gland Probing Plus Blephamide|"Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.~Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks."
52648|NCT02256969|O2|Outcome|Sham Meibomian Gland Probing Plus Lubricant|"Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.~Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
52649|NCT02256969|O1|Outcome|Meibomian Gland Probing Plus Lubricant|"Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.~Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
52650|NCT02256969|O3|Outcome|Meibomian Gland Probing Plus Blephamide|"Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.~Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks."
52651|NCT02256969|O2|Outcome|Sham Meibomian Gland Probing Plus Lubricant|"Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.~Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
52652|NCT02256969|O1|Outcome|Meibomian Gland Probing Plus Lubricant|"Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.~Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
52653|NCT02256969|E3|Reported Event|Meibomian Gland Probing Plus Blephamide|"Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.~Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks."
52654|NCT02256969|E2|Reported Event|Sham Meibomian Gland Probing Plus Lubricant|"Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.~Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
52655|NCT02256969|E1|Reported Event|Meibomian Gland Probing Plus Lubricant|"Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.~Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
52656|NCT02256891|B3|Baseline|Total|Total of all reporting groups
52657|NCT02256891|B2|Baseline|Double Row With PRFM|PRFM
52658|NCT02256891|B1|Baseline|Double Row Only|Double Row
52659|NCT02256891|P2|Participant Flow|Double Row With PRFM|"Double Row with PRFM~PRFM~Double Row"
52660|NCT02256891|P1|Participant Flow|Double Row|"Double Row~Double Row"
52661|NCT02256891|O2|Outcome|Double Row With PRFM|"Double Row with PRFM~PRFM~Double Row"
52662|NCT02256891|O1|Outcome|Double Row|"Double Row~Double Row"
52663|NCT02256891|O2|Outcome|Double Row With PRFM|"Double Row with PRFM~PRFM~Double Row"
52664|NCT02256891|O1|Outcome|Double Row|"Double Row~Double Row"
52665|NCT02256891|O2|Outcome|Double Row With PRFM|"Double Row with PRFM~PRFM~Double Row"
52666|NCT02256891|O1|Outcome|Double Row|"Double Row~Double Row"
52667|NCT02256891|O2|Outcome|Double Row With PRFM|"Double Row with PRFM~PRFM~Double Row"
52668|NCT02256891|O1|Outcome|Double Row|"Double Row~Double Row"
52669|NCT02256891|O2|Outcome|Double Row With PRFM|"Double Row with PRFM~PRFM~Double Row"
52670|NCT02256891|O1|Outcome|Double Row|"Double Row~Double Row"
52671|NCT02256891|O2|Outcome|Double Row With PRFM|"Double Row with PRFM~PRFM~Double Row"
52672|NCT02256891|O1|Outcome|Double Row|"Double Row~Double Row"
52673|NCT02256891|O2|Outcome|Double Row With PRFM|"Double Row with PRFM~PRFM~Double Row"
52674|NCT02256891|O1|Outcome|Double Row|"Double Row~Double Row"
52675|NCT02256891|O2|Outcome|Double Row With PRFM|"Double Row with PRFM~PRFM~Double Row"
52676|NCT02256891|O1|Outcome|Double Row|"Double Row~Double Row"
52677|NCT02256891|O2|Outcome|Double Row With PRFM|"Double Row with PRFM~PRFM~Double Row"
52678|NCT02256891|O1|Outcome|Double Row|"Double Row~Double Row"
52679|NCT02256891|O2|Outcome|Double Row With PRFM|PRFM
52680|NCT02256891|O1|Outcome|Double Row|Double Row
52681|NCT02256891|E2|Reported Event|Double Row With PRFM|"Double Row with PRFM~PRFM~Double Row"
52682|NCT02256891|E1|Reported Event|Double Row|"Double Row~Double Row"
52683|NCT02256553|B1|Baseline|MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
52684|NCT02256553|P1|Participant Flow|MK-3641+MK-7243|Participants receive one MK-7243 tablet, sublingually (SL) once a day (QD) in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
52685|NCT02256553|O1|Outcome|MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
52686|NCT02256553|O1|Outcome|MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
52687|NCT02256553|O1|Outcome|MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
52688|NCT02256553|O1|Outcome|MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
52689|NCT02256553|E3|Reported Event|Period III: MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
52690|NCT02256553|E2|Reported Event|Period II: MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
52691|NCT02256553|E1|Reported Event|Period I: MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
52692|NCT02256488|B5|Baseline|Total|Total of all reporting groups
52693|NCT02256488|B4|Baseline|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
52694|NCT02256488|B3|Baseline|TIVc_LOT C|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
52695|NCT02256488|B2|Baseline|TIVc_LOT B|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
52696|NCT02256488|B1|Baseline|TIVc_LOT A|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
52697|NCT02256488|P4|Participant Flow|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
52698|NCT02256488|P3|Participant Flow|TIVc_LOT C|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
52699|NCT02256488|P2|Participant Flow|TIVc_LOT B|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
52700|NCT02256488|P1|Participant Flow|TIVc_LOT A|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
52701|NCT02256488|O2|Outcome|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf;
52702|NCT02256488|O1|Outcome|TIVc (3 TIVc Lots Pooled)|Subjects 18 to ≤ 49 years of age who received one vaccination of an investigational vaccine TIVc
52703|NCT02256488|O2|Outcome|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf;
52704|NCT02256488|O1|Outcome|TIVc (3 TIVc Lots Pooled)|Subjects 18 to ≤ 49 years of age who received one vaccination of an investigational vaccine TIVc
52705|NCT02256488|O2|Outcome|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
52706|NCT02256488|O1|Outcome|TIVc (3 TIVc Lots Pooled)|Subjects 18 to ≤ 49 years of age who received one vaccination of an investigational vaccine TIVc
52707|NCT02256488|O3|Outcome|TIVc_LOT C|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
52708|NCT02256488|O2|Outcome|TIVc_LOT B|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
52709|NCT02256488|O1|Outcome|TIVc_LOT A|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
52710|NCT02256488|E3|Reported Event|Total|Total number of subjects
52711|NCT02256488|E2|Reported Event|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf;
52712|NCT02256488|E1|Reported Event|TIVc Pooled|Subjects 18 to ≤ 49 years of age who received one vaccination of an investigational vaccine TIVc
52713|NCT02256436|B3|Baseline|Total|Total of all reporting groups
52714|NCT02256436|B2|Baseline|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
52715|NCT02256436|B1|Baseline|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
52716|NCT02256436|P2|Participant Flow|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
52717|NCT02256436|P1|Participant Flow|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W).
52718|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
52719|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
52720|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
52721|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
52722|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
84023|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
52726|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
52727|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
52728|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
52729|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
52730|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
52731|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
52732|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
52733|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
52734|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
52735|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
52736|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
52737|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
52738|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
52739|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
52740|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
52741|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
52742|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
52743|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
52744|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
52745|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
52746|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
52747|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
52748|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
52749|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
52750|NCT02256436|E2|Reported Event|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
52751|NCT02256436|E1|Reported Event|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
52752|NCT02256358|B3|Baseline|Total|Total of all reporting groups
52753|NCT02256358|B2|Baseline|Ketamine|"Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.~Ketamine: Preoperatively injected intravenous 1mg/kg ketamine"
52754|NCT02256358|B1|Baseline|Midazolam|"Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.~Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam"
52755|NCT02256358|P2|Participant Flow|Ketamine|"Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.~Ketamine: Preoperatively injected intravenous 1mg/kg ketamine"
52756|NCT02256358|P1|Participant Flow|Midazolam|"Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.~Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam"
52757|NCT02256358|O2|Outcome|Ketamine|"Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.~Ketamine: Preoperatively injected intravenous 1mg/kg ketamine"
52758|NCT02256358|O1|Outcome|Midazolam|"Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.~Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam"
52759|NCT02256358|E2|Reported Event|Ketamine|"Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.~Ketamine: Preoperatively injected intravenous 1mg/kg ketamine"
52760|NCT02256358|E1|Reported Event|Midazolam|"Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.~Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam"
52761|NCT02256345|B3|Baseline|Total|Total of all reporting groups
52762|NCT02256345|B2|Baseline|Randomized to KCl|"KCl will be used as a placebo and will be given as 6 mmol twice daily for the first week, increasing to 6 mmol three times daily for the second week if tolerating well.~Placebo Comparator: Potassium Chloride"
52763|NCT02256345|B1|Baseline|Randomized to KNO3|"KNO3 will be given at a dose of 6 mmol twice daily for the first week, increasing to 6 mmol three times daily for the second week if well tolerated~Active Comparator: Potassium Nitrate"
52764|NCT02256345|P2|Participant Flow|Randomized to KCl|"KCl will be used as a placebo and will be given as 6 mmol twice daily for the first week, increasing to 6 mmol three times daily for the second week if well tolerated.~Placebo Comparator: Potassium Chloride (KCl)"
52765|NCT02256345|P1|Participant Flow|Randomized to KNO3|"KNO3 will be given at a dose of 6 mmol twice daily for the first week, increasing to 6 mmol three times daily for the second week if well tolerated.~Active Comparator: Potassium Nitrate (KNO3)"
52766|NCT02256345|O2|Outcome|Randomized to KCl|"KCl will be used as a placebo and will be given as 6 mmol twice daily for the first week, increasing to 6 mmol three times daily for the second week if tolerating well.~Placebo Comparator: Potassium Chloride"
52767|NCT02256345|O1|Outcome|Randomized to KNO3|"KNO3 will be given at a dose of 6 mmol twice daily for the first week, increasing to 6 mmol three times daily for the second week if well tolerated~Active Comparator: Potassium Nitrate"
52768|NCT02256345|O2|Outcome|Randomized to KCl|"KCl will be used as a placebo and will be given as 6 mmol twice daily for the first week, increasing to 6 mmol three times daily for the second week if tolerating well.~Placebo Comparator: Potassium Chloride"
52769|NCT02256345|O1|Outcome|Randomized to KNO3|"KNO3 will be given at a dose of 6 mmol twice daily for the first week, increasing to 6 mmol three times daily for the second week if well tolerated~Active Comparator: Potassium Nitrate"
52770|NCT02256345|O2|Outcome|Randomized to KCl|"KCl will be used as a placebo and will be given as 6 mmol twice daily for the first week, increasing to 6 mmol three times daily for the second week if tolerating well.~Placebo Comparator: Potassium Chloride"
52771|NCT02256345|O1|Outcome|Randomized to KNO3|"KNO3 will be given at a dose of 6 mmol twice daily for the first week, increasing to 6 mmol three times daily for the second week if well tolerated~Active Comparator: Potassium Nitrate"
52772|NCT02256345|O2|Outcome|Randomized to KCl|"KCl will be used as a placebo and will be given as 6 mmol twice daily for the first week, increasing to 6 mmol three times daily for the second week if tolerating well.~Placebo Comparator: Potassium Chloride"
52773|NCT02256345|O1|Outcome|Randomized to KNO3|"KNO3 will be given at a dose of 6 mmol twice daily for the first week, increasing to 6 mmol three times daily for the second week if well tolerated~Active Comparator: Potassium Nitrate"
52774|NCT02256345|E2|Reported Event|Randomized to KCl|"KCl will be used as a placebo and will be given as 6 mmol twice daily for the first week, increasing to 6 mmol three times daily for the second week if tolerating well.~Placebo Comparator: Potassium Chloride"
52775|NCT02256345|E1|Reported Event|Randomized to KNO3|"KNO3 will be given at a dose of 6 mmol twice daily for the first week, increasing to 6 mmol three times daily for the second week if well tolerated~Active Comparator: Potassium Nitrate"
52776|NCT02256072|B3|Baseline|Total|Total of all reporting groups
52777|NCT02256072|B2|Baseline|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
52778|NCT02256072|B1|Baseline|Plan Your Lifespan Website|"Participants in the intervention arm will navigate Planyourlifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.~Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte"
52779|NCT02256072|P2|Participant Flow|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
52780|NCT02256072|P1|Participant Flow|Plan Your Lifespan Website|Participants in the intervention arm will navigate PlanYourLifespan.org.
52781|NCT02256072|O2|Outcome|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
52782|NCT02256072|O1|Outcome|Plan Your Lifespan Website|"Participants in the intervention arm will navigate the Plan Your Lifespan website, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas described below.~Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making."
52809|NCT02255565|O9|Outcome|Low Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
52877|NCT02255279|O1|Outcome|Naive_aTIV (≥36 Months to < 72 Months)|A 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
84024|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
52783|NCT02256072|O2|Outcome|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
52784|NCT02256072|O1|Outcome|Plan Your Lifespan Website|"Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.~Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte"
52785|NCT02256072|O2|Outcome|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
52786|NCT02256072|O1|Outcome|Plan Your Lifespan Website|"Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.~Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte"
52787|NCT02256072|O2|Outcome|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
52788|NCT02256072|O1|Outcome|Plan Your Lifespan Website|"Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.~Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte"
52789|NCT02256072|O2|Outcome|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
52790|NCT02256072|O1|Outcome|Plan Your Lifespan Website|"Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.~Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte"
52791|NCT02256072|E2|Reported Event|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
52792|NCT02256072|E1|Reported Event|Plan Your Lifespan Website|"Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. PlanYourLifespan.org is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.~PlanYourLifespan.org: Participants in the intervention arm will navigate PlanYourLifespan.org, that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website."
52793|NCT02255565|B4|Baseline|Total|Total of all reporting groups
52794|NCT02255565|B3|Baseline|Moderate Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks.~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
52795|NCT02255565|B2|Baseline|Low Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
52796|NCT02255565|B1|Baseline|Very Low Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks.~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
52797|NCT02255565|P3|Participant Flow|Moderate Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks.~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
52798|NCT02255565|P2|Participant Flow|Low Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
52799|NCT02255565|P1|Participant Flow|Very Low Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks.~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
52800|NCT02255565|O18|Outcome|Moderate Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
52801|NCT02255565|O17|Outcome|Moderate Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
52802|NCT02255565|O16|Outcome|Moderate Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
52803|NCT02255565|O15|Outcome|Moderate Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
52804|NCT02255565|O14|Outcome|Moderate Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
52805|NCT02255565|O13|Outcome|Moderate Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
52806|NCT02255565|O12|Outcome|Low Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
52807|NCT02255565|O11|Outcome|Low Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
52808|NCT02255565|O10|Outcome|Low Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
52875|NCT02255279|O1|Outcome|Non-naive_aTIV (≥36 Months to < 72 Months)|A 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
53726|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
52810|NCT02255565|O8|Outcome|Low Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
52811|NCT02255565|O7|Outcome|Low Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
52812|NCT02255565|O6|Outcome|Very Low Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
52813|NCT02255565|O5|Outcome|Very Low Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
52814|NCT02255565|O4|Outcome|Very Low Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
52815|NCT02255565|O3|Outcome|Very Low Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
52816|NCT02255565|O2|Outcome|Very Low Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
52817|NCT02255565|O1|Outcome|Very Low Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
52818|NCT02255565|O18|Outcome|Moderate Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
52819|NCT02255565|O17|Outcome|Moderate Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
52820|NCT02255565|O16|Outcome|Moderate Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
52821|NCT02255565|O15|Outcome|Moderate Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
52822|NCT02255565|O14|Outcome|Moderate Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
52823|NCT02255565|O13|Outcome|Moderate Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
52824|NCT02255565|O12|Outcome|Low Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
52825|NCT02255565|O11|Outcome|Low Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
52826|NCT02255565|O10|Outcome|Low Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
52827|NCT02255565|O9|Outcome|Low Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
52828|NCT02255565|O8|Outcome|Low Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
52829|NCT02255565|O7|Outcome|Low Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
52830|NCT02255565|O6|Outcome|Very Low Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
52831|NCT02255565|O5|Outcome|Very Low Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
52832|NCT02255565|O4|Outcome|Very Low Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
52833|NCT02255565|O3|Outcome|Very Low Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
52834|NCT02255565|O2|Outcome|Very Low Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
52835|NCT02255565|O1|Outcome|Very Low Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
52836|NCT02255565|O18|Outcome|Moderate Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
52837|NCT02255565|O17|Outcome|Moderate Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
52838|NCT02255565|O16|Outcome|Moderate Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
52839|NCT02255565|O15|Outcome|Moderate Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
52840|NCT02255565|O14|Outcome|Moderate Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
52841|NCT02255565|O13|Outcome|Moderate Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
52842|NCT02255565|O12|Outcome|Low Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
52843|NCT02255565|O11|Outcome|Low Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
52844|NCT02255565|O10|Outcome|Low Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
52845|NCT02255565|O9|Outcome|Low Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
52846|NCT02255565|O8|Outcome|Low Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
52876|NCT02255279|O2|Outcome|Naive_TIV (≥36 Months to < 72 Months)|A 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
52878|NCT02255279|O2|Outcome|Non-naive_TIV (6 to <36 Months)|A 0.25 mL (for children 6 to <36 months old) dose of TIV to be administered.
52847|NCT02255565|O7|Outcome|Low Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
52848|NCT02255565|O6|Outcome|Very Low Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
52849|NCT02255565|O5|Outcome|Very Low Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
52850|NCT02255565|O4|Outcome|Very Low Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
52851|NCT02255565|O3|Outcome|Very Low Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
52852|NCT02255565|O2|Outcome|Very Low Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
52853|NCT02255565|O1|Outcome|Very Low Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
52854|NCT02255565|E3|Reported Event|Moderate Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks.~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
52855|NCT02255565|E2|Reported Event|Low Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
52856|NCT02255565|E1|Reported Event|Very Low Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks.~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
52857|NCT02255279|B3|Baseline|Total|Total of all reporting groups
52858|NCT02255279|B2|Baseline|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
52859|NCT02255279|B1|Baseline|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
52860|NCT02255279|P2|Participant Flow|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
52861|NCT02255279|P1|Participant Flow|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
52862|NCT02255279|O2|Outcome|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
52863|NCT02255279|O1|Outcome|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
52864|NCT02255279|O2|Outcome|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
52865|NCT02255279|O1|Outcome|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
52866|NCT02255279|O2|Outcome|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
52867|NCT02255279|O1|Outcome|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
52868|NCT02255279|O2|Outcome|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
52869|NCT02255279|O1|Outcome|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
52870|NCT02255279|O2|Outcome|Non naive_TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
52871|NCT02255279|O1|Outcome|Non naive_aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
52872|NCT02255279|O2|Outcome|Naive_TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
52873|NCT02255279|O1|Outcome|Naive_aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
52874|NCT02255279|O2|Outcome|Non-naive_TIV (≥36 Months to < 72 Months)|A 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
53103|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
52879|NCT02255279|O1|Outcome|Non-naive_aTIV (6 to <36 Months)|A 0.25 mL (for children 6 to <36 months old) dose of aTIV to be administered.
52880|NCT02255279|O2|Outcome|Naive_TIV (6 to <36 Months)|A 0.25 mL (for children 6 to <36 months old) dose of TIV to be administered.
52881|NCT02255279|O1|Outcome|Naive_aTIV (6 to <36 Months)|A 0.25 mL (for children 6 to <36 months old) dose of aTIV to be administered.
52882|NCT02255279|E4|Reported Event|Non-naive_TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered (Non-naive).
52883|NCT02255279|E3|Reported Event|Non-naive_aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered (Non-naive).
52884|NCT02255279|E2|Reported Event|Naive_TIV (6 Months to < 72 Months)|"A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered (Naive).~Enrolled subjects- 79 Exposed subjects- 78 Reason for discrepancy- Before vaccination one subject was withdrawn from study because of the suspected egg allergy."
52885|NCT02255279|E1|Reported Event|Naive_aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered (Naive).
52886|NCT02255149|B1|Baseline|Bone/Mesh|"Allograft and Titanium mesh will be used to grow jaw bone vertically.~Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow."
52887|NCT02255149|P1|Participant Flow|Bone/Mesh|"Allograft and Titanium mesh will be used to grow jaw bone vertically.~Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow."
52888|NCT02255149|O1|Outcome|Bone/Mesh|"Allograft and Titanium mesh will be used to grow jaw bone vertically.~Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow."
52889|NCT02255149|E1|Reported Event|Bone/Mesh|"Allograft and Titanium mesh will be used to grow jaw bone vertically.~Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow."
52890|NCT02255097|B1|Baseline|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
52891|NCT02255097|P1|Participant Flow|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
52892|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
52893|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
52894|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
52895|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
52896|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
52897|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
52898|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
52899|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
52900|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
52901|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
52902|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
52903|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
52904|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
52905|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
52906|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
52907|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
52908|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
52909|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
52910|NCT02255097|E1|Reported Event|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
52911|NCT02254772|B1|Baseline|Treatment|Patients receive TLR9 agonist SD-101 via intratumoral injections; ipilimumab via intratumoral injection; and undergo radiation therapy on days 1 and 2.
52912|NCT02254772|P1|Participant Flow|Treatment|Patients receive TLR9 agonist SD-101 via intratumoral injections; ipilimumab via intratumoral injection; and undergo radiation therapy on days 1 and 2.
52913|NCT02254772|O1|Outcome|Treatment|Patients receive TLR9 agonist SD-101 via intratumoral injections; ipilimumab via intratumoral injection; and undergo radiation therapy on days 1 and 2.
52914|NCT02254772|O1|Outcome|Treatment|Patients receive TLR9 agonist SD-101 via intratumoral injections; ipilimumab via intratumoral injection; and undergo radiation therapy on days 1 and 2.
52915|NCT02254772|O1|Outcome|Treatment|Patients receive TLR9 agonist SD-101 via intratumoral injections; ipilimumab via intratumoral injection; and undergo radiation therapy on days 1 and 2.
52916|NCT02254772|E1|Reported Event|Treatment|Patients receive TLR9 agonist SD-101 via intratumoral injections; ipilimumab via intratumoral injection; and undergo radiation therapy on days 1 and 2.
84025|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
52917|NCT02254551|B1|Baseline|LDE225 Plus Bortezomib|"Safety Lead-In: To determine the maximum tolerated dose (MTD), LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity."
52918|NCT02254551|P1|Participant Flow|LDE225 Plus Bortezomib|"Safety Lead-In: To determine the maximum tolerated dose (MTD), LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity."
52919|NCT02254551|O1|Outcome|LDE225 Plus Bortezomib|"Safety Lead-In: LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg for 21 days.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity."
52920|NCT02254551|O1|Outcome|LDE225 Plus Bortezomib|"Safety Lead-In: LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg for 21 days.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity."
52921|NCT02254551|O1|Outcome|LDE225 Plus Bortezomib|"Safety Lead-In: To determine the maximum tolerated dose (MTD), LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity"
52922|NCT02254551|E3|Reported Event|Cohort 3: LDE225 800mg/m^2|"Cohort 3 will receive LDE225 orally on a daily basis, at 800mg/m^2 every 21 days.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle."
52923|NCT02254551|E2|Reported Event|Cohort 2: LDE225 600mg/m^2|Cohort 2 will receive LDE225 orally on a daily basis, at 600 mg every 21 days. Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.
52924|NCT02254551|E1|Reported Event|Cohort 1: LDE225 400mg/m^2|"Cohort 1 will receive LDE225 orally on a daily basis, at 400mg/m^2 every 21 days.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle."
52925|NCT02254486|B3|Baseline|Total|Total of all reporting groups
52926|NCT02254486|B2|Baseline|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
52927|NCT02254486|B1|Baseline|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
52928|NCT02254486|P2|Participant Flow|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
52929|NCT02254486|P1|Participant Flow|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
52930|NCT02254486|O2|Outcome|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
52931|NCT02254486|O1|Outcome|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
52932|NCT02254486|O2|Outcome|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
52933|NCT02254486|O1|Outcome|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
52934|NCT02254486|O2|Outcome|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
52935|NCT02254486|O1|Outcome|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
52936|NCT02254486|O2|Outcome|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
52937|NCT02254486|O1|Outcome|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
52938|NCT02254486|O2|Outcome|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
52939|NCT02254486|O1|Outcome|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
84107|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
52940|NCT02254486|O2|Outcome|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
52941|NCT02254486|O1|Outcome|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
52942|NCT02254486|E2|Reported Event|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
52943|NCT02254486|E1|Reported Event|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
52944|NCT02254460|B1|Baseline|Overall|Micronutrient fortified nutritional beverage powder (test) and energy, iron and calcium equivalent beverage powder without micronutrient fortification (control), packed as 27 g individual sachets, administered as a single serve in a total volume of 100 mL lukewarm milk for oral consumption. 1mL solution containing 3mg/mL of the stable isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder. Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.
52945|NCT02254460|P2|Participant Flow|Control Follwed by Test|Patients first received energy, iron and calcium equivalent beverage powder without micronutrient fortification (control) and then micronutrient fortified nutritional beverage powder (test), packed as 27g individual sachets, administered as a single serve in a total volume of 100mL of lukewarm milk for oral consumption. 1mL solution containing 3mg/mL of the stable iron isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder. Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.
52946|NCT02254460|P1|Participant Flow|Test Followed by Control|Patients first received micronutrient fortified nutritional beverage powder (test) and then energy, iron and calcium equivalent beverage powder without micronutrient fortification (control), packed as 27 grams (g) individual sachets, administered as a single serve in a total volume of 100 milliliters (mL) lukewarm milk for oral consumption. 1mL solution containing 3 milligrams/milliliters (mg/mL) of the stable iron isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder. Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage
52947|NCT02254460|O2|Outcome|Control|Energy, iron and calcium equivalent beverage powder without micronutrient fortification, packed as 27g individual sachets, administered as a single serve in a total volume of 100mL of lukewarm milk for oral consumption.1mL solution containing 3mg/mL of the stable iron isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder (control). Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.
52948|NCT02254460|O1|Outcome|Test|Micronutrient fortified nutritional beverage powder, packed as 27g individual sachets, administered as a single serve in a total volume of 100 mL lukewarm milk for oral consumption. 1mL solution containing 3mg/mL of the stable iron isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder (test). Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.
52949|NCT02254460|E2|Reported Event|Control|Energy, iron and calcium equivalent beverage powder without micronutrient fortification, packed as 27g individual sachets, administered as a single serve in a total volume of 100mL of lukewarm milk for oral consumption. 1mL solution containing 3mg/mL of the stable iron isotope (57Fe, 58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder (control). Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.
52950|NCT02254460|E1|Reported Event|Test|Micronutrient fortified nutritional beverage powder, packed as 27g individual sachets, administered as a single serve in a total volume of 100 mL lukewarm milk for oral consumption. 1mL solution containing 3mg/mL of the stable iron isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder (test). Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.
52951|NCT02254421|B3|Baseline|Total|Total of all reporting groups
52952|NCT02254421|B2|Baseline|Placebo|Placebo tablets on Days 1, 5, 9, 13, and 17 administered orally or via nasogastric tube
52953|NCT02254421|B1|Baseline|Presatovir|Presatovir 200 mg (4 x 50 mg tablets) on Days 1, 5, 9, 13, and 17 administered orally or via nasogastric tube
52954|NCT02254421|P2|Participant Flow|Placebo|Placebo tablets on Days 1, 5, 9, 13, and 17 administered orally or via nasogastric tube
52955|NCT02254421|P1|Participant Flow|Presatovir|Presatovir 200 mg (4 x 50 mg tablets) on Days 1, 5, 9, 13, and 17 administered orally or via nasogastric tube
52956|NCT02254421|O2|Outcome|Placebo|Placebo tablets on Days 1, 5, 9, 13, and 17 administered orally or via nasogastric tube
52957|NCT02254421|O1|Outcome|Presatovir|Presatovir 200 mg (4 x 50 mg tablets) on Days 1, 5, 9, 13, and 17 administered orally or via nasogastric tube
52958|NCT02254421|O2|Outcome|Placebo|Placebo tablets on Days 1, 5, 9, 13, and 17 administered orally or via nasogastric tube
52959|NCT02254421|O1|Outcome|Presatovir|Presatovir 200 mg (4 x 50 mg tablets) on Days 1, 5, 9, 13, and 17 administered orally or via nasogastric tube
52960|NCT02254421|O2|Outcome|Placebo|Placebo tablets on Days 1, 5, 9, 13, and 17 administered orally or via nasogastric tube
52961|NCT02254421|O1|Outcome|Presatovir|Presatovir 200 mg (4 x 50 mg tablets) on Days 1, 5, 9, 13, and 17 administered orally or via nasogastric tube
52962|NCT02254421|O2|Outcome|Placebo|Placebo tablets on Days 1, 5, 9, 13, and 17 administered orally or via nasogastric tube
52963|NCT02254421|O1|Outcome|Presatovir|Presatovir 200 mg (4 x 50 mg tablets) on Days 1, 5, 9, 13, and 17 administered orally or via nasogastric tube
52964|NCT02254421|E2|Reported Event|Placebo|Placebo tablets on Days 1, 5, 9, 13, and 17 administered orally or via nasogastric tube
52965|NCT02254421|E1|Reported Event|Presatovir|Presatovir 200 mg (4 x 50 mg tablets) on Days 1, 5, 9, 13, and 17 administered orally or via nasogastric tube
52966|NCT02254304|B3|Baseline|Total|Total of all reporting groups
52967|NCT02254304|B2|Baseline|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53104|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
52968|NCT02254304|B1|Baseline|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52969|NCT02254304|P2|Participant Flow|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52970|NCT02254304|P1|Participant Flow|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52971|NCT02254304|O1|Outcome|Rebif In RMS and CIS Subjects|Rebif was administered in RMS and CIS subjects at a dose of 44 mcg subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52972|NCT02254304|O2|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52973|NCT02254304|O1|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52974|NCT02254304|O1|Outcome|Rebif|Rebif was administered in RMS and CIS subjects at a dose of 44 mcg subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52975|NCT02254304|O2|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52976|NCT02254304|O1|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52977|NCT02254304|O2|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52978|NCT02254304|O1|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52979|NCT02254304|O2|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52980|NCT02254304|O1|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52981|NCT02254304|O2|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52982|NCT02254304|O1|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52983|NCT02254304|O2|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52984|NCT02254304|O1|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52985|NCT02254304|O2|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52986|NCT02254304|O1|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52987|NCT02254304|O2|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52988|NCT02254304|O1|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52989|NCT02254304|O2|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52990|NCT02254304|O1|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52991|NCT02254304|O2|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52992|NCT02254304|O1|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52993|NCT02254304|O2|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52994|NCT02254304|O1|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53105|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
84108|NCT02061358|O9|Outcome|Placebo|Placebo oral, single dose
52995|NCT02254304|O2|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52996|NCT02254304|O1|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52997|NCT02254304|O2|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52998|NCT02254304|O1|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
52999|NCT02254304|O2|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53000|NCT02254304|O1|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53001|NCT02254304|O2|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53002|NCT02254304|O1|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53003|NCT02254304|O2|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53004|NCT02254304|O1|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53005|NCT02254304|O2|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53006|NCT02254304|O1|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53007|NCT02254304|O2|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53008|NCT02254304|O1|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53009|NCT02254304|O2|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53010|NCT02254304|O1|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53011|NCT02254304|O1|Outcome|Rebif In RMS and CIS Subjects|Rebif was administered in RMS and CIS subjects at a dose of 44 mcg subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53012|NCT02254304|O1|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53013|NCT02254304|O2|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53014|NCT02254304|O1|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53015|NCT02254304|O2|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53016|NCT02254304|O1|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53017|NCT02254304|O2|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53018|NCT02254304|O1|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53019|NCT02254304|O2|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53020|NCT02254304|O1|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53021|NCT02254304|O2|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53106|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53022|NCT02254304|O1|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53023|NCT02254304|O1|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53024|NCT02254304|O1|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53025|NCT02254304|E1|Reported Event|Rebif|Rebif was administered in RMS and CIS subjects at a dose of 44 mcg subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
53026|NCT02254252|B3|Baseline|Total|Total of all reporting groups
53027|NCT02254252|B2|Baseline|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nicorandil: nicorandil (10mg tablets, two times a day)"
53028|NCT02254252|B1|Baseline|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
53029|NCT02254252|P2|Participant Flow|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nicorandil: nicorandil (10mg tablets, two times a day)"
53030|NCT02254252|P1|Participant Flow|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
53031|NCT02254252|O2|Outcome|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nicorandil: nicorandil (10mg tablets, two times a day)"
53032|NCT02254252|O1|Outcome|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
53033|NCT02254252|O2|Outcome|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nicorandil: nicorandil (10mg tablets, two times a day)"
53034|NCT02254252|O1|Outcome|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
53035|NCT02254252|O2|Outcome|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nicorandil: nicorandil (10mg tablets, two times a day)"
53036|NCT02254252|O1|Outcome|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
53037|NCT02254252|E2|Reported Event|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nicorandil: nicorandil (10mg tablets, two times a day)"
53038|NCT02254252|E1|Reported Event|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
53039|NCT02253654|B3|Baseline|Total|Total of all reporting groups
53040|NCT02253654|B2|Baseline|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
53041|NCT02253654|B1|Baseline|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
53042|NCT02253654|P2|Participant Flow|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
53043|NCT02253654|P1|Participant Flow|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
86625|NCT02044302|O1|Outcome|Terminated Cohort|
53044|NCT02253654|O2|Outcome|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
53045|NCT02253654|O1|Outcome|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
53046|NCT02253654|O2|Outcome|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
53047|NCT02253654|O1|Outcome|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
53048|NCT02253654|O2|Outcome|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
53049|NCT02253654|O1|Outcome|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
53050|NCT02253654|O2|Outcome|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
53051|NCT02253654|O1|Outcome|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
53052|NCT02253654|O2|Outcome|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
53053|NCT02253654|O1|Outcome|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
53054|NCT02253654|O2|Outcome|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
53055|NCT02253654|O1|Outcome|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
53056|NCT02253654|O2|Outcome|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
53057|NCT02253654|O1|Outcome|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
53107|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53108|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
86626|NCT02044302|O1|Outcome|Terminated Cohort|
53058|NCT02253654|O2|Outcome|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
53059|NCT02253654|O1|Outcome|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
53060|NCT02253654|E2|Reported Event|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
53061|NCT02253654|E1|Reported Event|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
53062|NCT02253173|B5|Baseline|Total|Total of all reporting groups
53063|NCT02253173|B4|Baseline|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53064|NCT02253173|B3|Baseline|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53065|NCT02253173|B2|Baseline|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53066|NCT02253173|B1|Baseline|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53067|NCT02253173|P4|Participant Flow|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53068|NCT02253173|P3|Participant Flow|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53069|NCT02253173|P2|Participant Flow|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53070|NCT02253173|P1|Participant Flow|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53071|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53072|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53073|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53074|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53075|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53076|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53077|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53078|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53079|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53080|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53081|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53082|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53083|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53084|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53085|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53086|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53087|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53088|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53089|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53090|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53091|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53092|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53093|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53094|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53095|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53096|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53097|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53098|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53099|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53100|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53101|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53102|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53109|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53110|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53111|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53112|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53113|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53114|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53115|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53116|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53117|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53118|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53119|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53120|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53121|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53122|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53123|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53124|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53125|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53126|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53127|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53128|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53129|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53130|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53131|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53132|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53133|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53134|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53135|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53136|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53137|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53138|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53139|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53140|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53141|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53142|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53143|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53144|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53145|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53146|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53147|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53148|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53149|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53150|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53151|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53152|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53153|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53154|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53155|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53156|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53157|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53158|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53159|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53160|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53161|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53162|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53163|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53164|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
86627|NCT02044302|O1|Outcome|Terminated Cohort|
53165|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53166|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53167|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53168|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53169|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53170|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53171|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53172|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53173|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53174|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53175|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53176|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53177|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53178|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53179|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53180|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53181|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53182|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53183|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53184|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53185|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53186|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53187|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53188|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53189|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53190|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53191|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53192|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53193|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53194|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53195|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53196|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53197|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53198|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53199|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53200|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53201|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53202|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53203|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53204|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53205|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53206|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53207|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53208|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53209|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53210|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53211|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53212|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53213|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53214|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53215|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53216|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53217|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53218|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53219|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53220|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
86628|NCT02044302|E1|Reported Event|Terminated Cohort|
53221|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53222|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53223|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53224|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53225|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53226|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53227|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53228|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53229|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53230|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53231|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53232|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53233|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53234|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53235|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53236|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53237|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53238|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53239|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
53240|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
53241|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
53242|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
53243|NCT02253173|O4|Outcome|Placebo|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
53244|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
53245|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
53246|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
53247|NCT02253173|O4|Outcome|Placebo|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
53248|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
53249|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
53250|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
53251|NCT02253173|O4|Outcome|Placebo|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
53252|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
53253|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
53254|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
53255|NCT02253173|O4|Outcome|Placebo|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
53256|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
53257|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
53258|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
53259|NCT02253173|E4|Reported Event|Placebo|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
53260|NCT02253173|E3|Reported Event|Estradiol 25mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
53261|NCT02253173|E2|Reported Event|Estradiol 10mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
53262|NCT02253173|E1|Reported Event|Estradiol 4mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
53263|NCT02253160|B4|Baseline|Total|Total of all reporting groups
53337|NCT02252965|B2|Baseline|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
53361|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
53264|NCT02253160|B3|Baseline|COBE Spectra MNC First, Then Spectra Optia CMNC|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53265|NCT02253160|B2|Baseline|Spectra Optia CMNC First, Then COBE Spectra MNC|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53266|NCT02253160|B1|Baseline|Lead-in Donor|Subjects screened and enrolled for the purpose of training on the investigational procedure only. Included in safety analysis only.
53267|NCT02253160|P3|Participant Flow|COBE Spectra MNC First, Then Spectra Optia CMNC|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53268|NCT02253160|P2|Participant Flow|Spectra Optia CMNC First, Then COBE Spectra MNC|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53269|NCT02253160|P1|Participant Flow|Lead-in Donor|Subjects screened and enrolled for the purpose of training on the investigational procedure only. Included in safety analysis only.
53270|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53271|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53272|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53338|NCT02252965|B1|Baseline|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 milligram (mg) for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
53727|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
53273|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53274|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53275|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53276|NCT02253160|O2|Outcome|COBE Spectra|Subjects who received an CMNC collection using the COBE Spectra
53277|NCT02253160|O1|Outcome|Spectra Optia|Subjects who received an CMNC collection using the Spectra Optia
53278|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53279|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53280|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53281|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53339|NCT02252965|P2|Participant Flow|Metformin XR|Subjects received Metformin Extended Release (XR) tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
53362|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
53282|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53283|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53284|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53285|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53286|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53287|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53288|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53289|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53290|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53291|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53292|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53293|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53294|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53295|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53296|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53297|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53298|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53299|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
53300|NCT02253160|E4|Reported Event|Follow up|Subjects who completed cross-over design and were followed for at least 1 day.
53301|NCT02253160|E3|Reported Event|COBE Spectra|Subjects who received COBE Spectra MNC collection procedure.
53302|NCT02253160|E2|Reported Event|Spectra Optia|Subject who received Spectra Optia CMNC collection procedure.
53303|NCT02253160|E1|Reported Event|Pre-collection|Subjects screened and received G-CSF.
53304|NCT02253147|B1|Baseline|TEOSYAL® RHA Ultra Deep / Perlane-L®|"Split-face injection of TEOSYAL® RHA Ultra Deep into one NLF and Perlane-L® into the contralateral NLF. Up to 3.0 mL injected per NLF (deep-dermis to superficial subcutaneous). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).~TEOSYAL® RHA Ultra Deep: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 27G½” disposable sterile needles."
53305|NCT02253147|P1|Participant Flow|TEOSYAL® RHA Ultra Deep / Perlane-L®|"Split-face injection of TEOSYAL® RHA Ultra Deep into one NLF and Perlane-L® into the contralateral NLF. Up to 3.0 mL injected per NLF (deep-dermis to superficial subcutaneous). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).~TEOSYAL® RHA Ultra Deep: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 27G½” disposable sterile needles."
53306|NCT02253147|O2|Outcome|Perlane-L®|Injection of Perlane-L® into the controlateral NLF
53307|NCT02253147|O1|Outcome|TEOSYAL® RHA Ultra Deep|Injection of TEOSYAL® RHA Ultra Deep into one NLF
53308|NCT02253147|O2|Outcome|Perlane-L®|Injection of Perlane-L® into the controlateral NLF
53309|NCT02253147|O1|Outcome|TEOSYAL® RHA Ultra Deep|Injection of TEOSYAL® RHA Ultra Deep into one NLF
53310|NCT02253147|O2|Outcome|Perlane-L®|Injection of Perlane-L® into the controlateral NLF
53311|NCT02253147|O1|Outcome|TEOSYAL® RHA Ultra Deep|Injection of TEOSYAL® RHA Ultra Deep into one NLF
53312|NCT02253147|O2|Outcome|Perlane-L®|Injection of Perlane-L® into the controlateral NLF
53313|NCT02253147|O1|Outcome|TEOSYAL® RHA Ultra Deep|Injection of TEOSYAL® RHA Ultra Deep into one NLF
53314|NCT02253147|O2|Outcome|Perlane-L®|Injection of Perlane-L® into the controlateral NLF
53315|NCT02253147|O1|Outcome|TEOSYAL® RHA Ultra Deep|Injection of TEOSYAL® RHA Ultra Deep into one NLF
53316|NCT02253147|O2|Outcome|Perlane-L®|Injection of Perlane-L® into the controlateral NLF
53317|NCT02253147|O1|Outcome|TEOSYAL® RHA Ultra Deep|Injection of TEOSYAL® RHA Ultra Deep into one NLF
53318|NCT02253147|O2|Outcome|Perlane-L®|Injection of Perlane-L® into the controlateral NLF
53319|NCT02253147|O1|Outcome|TEOSYAL® RHA Ultra Deep|Injection of TEOSYAL® RHA Ultra Deep into one NLF
53320|NCT02253147|O2|Outcome|Perlane-L®|Injection of Perlane-L® into the controlateral NLF
53321|NCT02253147|O1|Outcome|TEOSYAL® RHA Ultra Deep|Injection of TEOSYAL® RHA Ultra Deep into one NLF
53322|NCT02253147|O2|Outcome|Perlane-L®|Injection of Perlane-L® into the controlateral NLF
53323|NCT02253147|O1|Outcome|TEOSYAL® RHA Ultra Deep|Injection of TEOSYAL® RHA Ultra Deep into one NLF
53324|NCT02253147|O2|Outcome|Perlane-L®|Injection of Perlane-L® into the controlateral NLF
53325|NCT02253147|O1|Outcome|TEOSYAL® RHA Ultra Deep|Injection of TEOSYAL® RHA Ultra Deep into one NLF
53326|NCT02253147|O2|Outcome|Perlane-L®|Injection of Perlane-L® into the controlateral NLF
53327|NCT02253147|O1|Outcome|TEOSYAL® RHA Ultra Deep|Injection of TEOSYAL® RHA Ultra Deep into one NLF
53328|NCT02253147|O2|Outcome|Perlane-L®|Injection of Perlane-L® into the controlateral NLF
53329|NCT02253147|O1|Outcome|TEOSYAL® RHA Ultra Deep|Injection of TEOSYAL® RHA Ultra Deep into one NLF
53330|NCT02253147|O2|Outcome|Perlane-L®|Injection of Perlane-L® into the controlateral NLF
53331|NCT02253147|O1|Outcome|TEOSYAL® RHA Ultra Deep|Injection of TEOSYAL® RHA Ultra Deep into one NLF
53332|NCT02253147|O2|Outcome|Perlane-L®|Injection of Perlane-L® into the controlateral NLF
53333|NCT02253147|O1|Outcome|TEOSYAL® RHA Ultra Deep|Injection of TEOSYAL® RHA Ultra Deep into one NLF
53334|NCT02253147|E2|Reported Event|Perlane-L®|Injection of Perlane-L® into the controlateral NLF
53335|NCT02253147|E1|Reported Event|TEOSYAL® RHA Ultra Deep|Injection of TEOSYAL® RHA Ultra Deep into one NLF
53336|NCT02252965|B3|Baseline|Total|Total of all reporting groups
53728|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
53340|NCT02252965|P1|Participant Flow|Metformin IR|Subjects received Metformin Immediate Release (IR) tablets, orally once daily (QD) at a dose of 500 milligram (mg) for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
53341|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
53342|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
53343|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
53344|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
53345|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
53346|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
53347|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
53348|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
53349|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
53350|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
53351|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
53352|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
53353|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16
53354|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
53355|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
53356|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
53357|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16
53358|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
53359|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
53360|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
53363|NCT02252965|E3|Reported Event|Metformin IR to XR|Subjects who received Metformin IR tablets initially, but were shifted to Metformin XR group due to intolerance to Metformin IR.
53364|NCT02252965|E2|Reported Event|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
53365|NCT02252965|E1|Reported Event|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
53366|NCT02252939|B1|Baseline|Patients With Trapeziometacarpal (TMC) Arthrosis|"Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis~X-Ray: X-ray as part of standard care"
53367|NCT02252939|P1|Participant Flow|Patients With Trapeziometacarpal (TMC) Arthrosis|"Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis~X-Ray: X-ray as part of standard care"
53368|NCT02252939|O1|Outcome|Patients With Trapeziometacarpal (TMC) Arthrosis|"Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis~X-Ray: X-ray as part of standard care"
53369|NCT02252939|E1|Reported Event|Patients With Trapeziometacarpal (TMC) Arthrosis|"Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis~X-Ray: X-ray as part of standard care"
53370|NCT02252744|B1|Baseline|RA Patients|Adult patients diagnosed with rheumatoid arthritis
53371|NCT02252744|P1|Participant Flow|RA Patients|Adult patients diagnosed with rheumatoid arthritis
53372|NCT02252744|O1|Outcome|RA Patients|Adult patients diagnosed with rheumatoid arthritis
53373|NCT02252744|E1|Reported Event|RA Patients|Adult patients diagnosed with rheumatoid arthritis
53374|NCT02252718|B1|Baseline|Children 2-18 Months of Age|Children between 2 and 18 months of age who were not toilet trained
53375|NCT02252718|P1|Participant Flow|Children 2-18 Months of Age|"Children aged between 2 and 18 months of age, who were not toilet trained, admitted to the Department of Pediatrics The Medical University of Warsaw~Stool Assessment: After passing a stool by the child participating in the study, within the shortest possible time (<5 min), the stool will be assessed independently and simulataneously by one of the parents and the medical doctor. They were unaware of the evaluation results made by the other. At the same time 2 photos were taken with smartphone camera. Then the photographs were subsequently evaluated by the other physician (MD2), who was unaware of the in vivo stool evaluation."
53376|NCT02252718|O1|Outcome|Children 2-18 Months of Age|"Children aged between 2 and 18 months of age, who were not toilet trained, admitted to the Department of Pediatrics The Medical University of Warsaw~Stool Assessment: After passing a stool by the child participating in the study, within the shortest possible time (<5 min), the stool will be assessed independently and simulataneously by one of the parents and the medical doctor. They were unaware of the evaluation results made by the other. At the same time 2 photos were taken with smartphone camera. Then the photographs were subsequently evaluated by the other physician (MD2), who was unaware of the in vivo stool evaluation."
53377|NCT02252718|E1|Reported Event|Children 2-18 Months of Age|"Children aged between 2 and 18 months of age, who were not toilet trained, admitted to the Department of Pediatrics The Medical University of Warsaw~Stool Assessment: After passing a stool by the child participating in the study, within the shortest possible time (<5 min), the stool will be assessed independently and simulataneously by one of the parents and the medical doctor. They were unaware of the evaluation results made by the other. At the same time 2 photos were taken with smartphone camera. Then the photographs were subsequently evaluated by the other physician (MD2), who was unaware of the in vivo stool evaluation."
53378|NCT02252445|B3|Baseline|Total|Total of all reporting groups
53379|NCT02252445|B2|Baseline|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
53380|NCT02252445|B1|Baseline|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
53381|NCT02252445|P2|Participant Flow|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
53382|NCT02252445|P1|Participant Flow|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
53383|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
53384|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
53385|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
53386|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
53387|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
53388|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
53389|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
53390|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
53391|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
53392|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
53393|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
53394|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
53395|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
53445|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53396|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
53397|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
53398|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
53399|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
53400|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
53401|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
53402|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
53403|NCT02252445|E2|Reported Event|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
53404|NCT02252445|E1|Reported Event|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
53405|NCT02252354|B3|Baseline|Total|Total of all reporting groups
53406|NCT02252354|B2|Baseline|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
53407|NCT02252354|B1|Baseline|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53408|NCT02252354|P2|Participant Flow|Part 2: TAK-385 + [14C]-TAK-385|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
53409|NCT02252354|P1|Participant Flow|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53410|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
53411|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53412|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53413|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53414|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53415|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53416|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53417|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53418|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53419|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53420|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53421|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53422|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53423|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53424|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
53425|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
53426|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53427|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
53428|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53429|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
53430|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
53431|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
53432|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
53433|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
53434|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
53435|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
53436|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
53437|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
53438|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
53439|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
53440|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53441|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53442|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53443|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53444|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53446|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53447|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53448|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53449|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53450|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53451|NCT02252354|E2|Reported Event|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
53452|NCT02252354|E1|Reported Event|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
53453|NCT02252146|B1|Baseline|IMO-8400|"IMO-8400 0.3 mg/kg twice weekly, 0.6 mg/kg twice weekly, or 1.2 mg/kg twice weekly~IMO-8400: MO-8400 given subcutaneously twice weekly"
53454|NCT02252146|P1|Participant Flow|IMO-8400|"IMO-8400 0.3 mg/kg twice weekly, 0.6 mg/kg twice weekly, or 1.2 mg/kg twice weekly~IMO-8400: IMO-8400 given subcutaneously twice weekly"
53455|NCT02252146|O1|Outcome|IMO-8400|"IMO-8400 0.3 mg/kg twice weekly, 0.6 mg/kg twice weekly, or 1.2 mg/kg twice weekly~IMO-8400: MO-8400 given subcutaneously twice weekly"
53456|NCT02252146|E1|Reported Event|IMO-8400|"IMO-8400 0.3 mg/kg twice weekly, 0.6 mg/kg twice weekly, or 1.2 mg/kg twice weekly~IMO-8400: MO-8400 given subcutaneously twice weekly"
53457|NCT02252133|B1|Baseline|Overall|DAILIES TOTAL1® and 1-Day Acuvue® TruEye® contact lenses worn during Period 1 and Period 2 in a crossover assignment.
53458|NCT02252133|P2|Participant Flow|1DAVTE, Then DT1|Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.
53459|NCT02252133|P1|Participant Flow|DT1, Then 1DAVTE|Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.
53460|NCT02252133|O2|Outcome|1DAVTE|Narafilcon A contact lenses worn during Period 1 or Period 2 for 7 days.
53461|NCT02252133|O1|Outcome|Dailies Total 1|Delefilcon A contact lenses during Period 1 or Period 2 for 7 days.
53462|NCT02252133|E2|Reported Event|1DAVTE|All subjects who wore narafilcon A contact lenses
53463|NCT02252133|E1|Reported Event|Dailies Total 1|All subjects who wore delefilcon A contact lenses
53464|NCT02252016|B3|Baseline|Total|Total of all reporting groups
53465|NCT02252016|B2|Baseline|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
53466|NCT02252016|B1|Baseline|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
53467|NCT02252016|P2|Participant Flow|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
53468|NCT02252016|P1|Participant Flow|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
53469|NCT02252016|O2|Outcome|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
53470|NCT02252016|O1|Outcome|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
53471|NCT02252016|O2|Outcome|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
53472|NCT02252016|O1|Outcome|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
53473|NCT02252016|O2|Outcome|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
53474|NCT02252016|O1|Outcome|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
53475|NCT02252016|O2|Outcome|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
53476|NCT02252016|O1|Outcome|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
53477|NCT02252016|E2|Reported Event|Deferred Treatment: Placebo Phase|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
53478|NCT02252016|E1|Reported Event|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
53479|NCT02251990|B3|Baseline|Total|Total of all reporting groups
53480|NCT02251990|B2|Baseline|Deferred Treatment Group (DTG): Placebo > Grazoprevir/Elbasvir|Participants received a placebo tablet q.d. by mouth for 12 weeks (placebo treatment period). After a 4-week Follow-Up period, participants received open-label grazoprevir/elbasvir FDC during a 12-week Active Treatment period (Week 16 to Week 28). Participants were then followed-up for 24 weeks to Week 52.
53481|NCT02251990|B1|Baseline|Immediate Treatment Group (ITG): Grazoprevir/Elbasvir|Participants received a grazoprevir/elbasvir FDC tablet q.d. by mouth during a 12-week Active Treatment period (Week 1 to Week 12) and were followed-up for 24 weeks to Week 36.
53482|NCT02251990|P2|Participant Flow|Deferred Treatment Group (DTG): Placebo > Grazoprevir/Elbasvir|Participants received a placebo tablet q.d. by mouth for 12 weeks (placebo treatment period). After a 4-week Follow-Up period, participants received open-label grazoprevir/elbasvir FDC during a 12-week Active Treatment period (Week 16 to Week 28). Participants were then followed-up for 24 weeks to Week 52.
53483|NCT02251990|P1|Participant Flow|Immediate Treatment Group (ITG): Grazoprevir/Elbasvir|Participants received a grazoprevir/elbasvir fixed-dose combination (FDC) tablet once daily (q.d.) by mouth during a 12-week Active Treatment period (Week 1 to Week 12) and were followed-up for 24 weeks to Week 36.
53484|NCT02251990|O2|Outcome|Deferred Treatment Group (DTG): Placebo > Grazoprevir/Elbasvir|Participants received a placebo tablet q.d. by mouth for 12 weeks (placebo treatment period). After a 4-week Follow-Up period, participants received open-label grazoprevir/elbasvir FDC during a 12-week Active Treatment period (Week 16 to Week 28). Participants were then followed-up for 24 weeks to Week 52.
53485|NCT02251990|O1|Outcome|Immediate Treatment Group (ITG): Grazoprevir/Elbasvir|Participants received a grazoprevir/elbasvir FDC tablet q.d. by mouth during a 12-week Active Treatment period (Week 1 to Week 12) and were followed-up for 24 weeks to Week 36.
53486|NCT02251990|O2|Outcome|Deferred Treatment Group (DTG): Placebo > Grazoprevir/Elbasvir|Participants received a placebo tablet q.d. by mouth for 12 weeks (placebo treatment period). After a 4-week Follow-Up period, participants received open-label grazoprevir/elbasvir FDC during a 12-week Active Treatment period (Week 16 to Week 28). Participants were then followed-up for 24 weeks to Week 52.
53487|NCT02251990|O1|Outcome|Immediate Treatment Group (ITG): Grazoprevir/Elbasvir|Participants received a grazoprevir/elbasvir FDC tablet q.d. by mouth during a 12-week Active Treatment period (Week 1 to Week 12) and were followed-up for 24 weeks to Week 36.
53488|NCT02251990|O2|Outcome|Deferred Treatment Group (DTG): Placebo > Grazoprevir/Elbasvir|Participants received a placebo tablet q.d. by mouth for 12 weeks (placebo treatment period). After a 4-week Follow-Up period, participants received open-label grazoprevir/elbasvir FDC during a 12-week Active Treatment period (Week 16 to Week 28). Participants were then followed-up for 24 weeks to Week 52.
53489|NCT02251990|O1|Outcome|Immediate Treatment Group (ITG): Grazoprevir/Elbasvir|Participants received a grazoprevir/elbasvir FDC tablet q.d. by mouth during a 12-week Active Treatment period (Week 1 to Week 12) and were followed-up for 24 weeks to Week 36.
53490|NCT02251990|O2|Outcome|Deferred Treatment Group (DTG): Placebo > Grazoprevir/Elbasvir|Participants received a placebo tablet q.d. by mouth for 12 weeks (placebo treatment period). After a 4-week Follow-Up period, participants received open-label grazoprevir/elbasvir FDC during a 12-week Active Treatment period (Week 16 to Week 28). Participants were then followed-up for 24 weeks to Week 52.
53491|NCT02251990|O1|Outcome|Immediate Treatment Group (ITG): Grazoprevir/Elbasvir|Participants received a grazoprevir/elbasvir FDC tablet q.d. by mouth during a 12-week Active Treatment period (Week 1 to Week 12) and were followed-up for 24 weeks to Week 36.
53492|NCT02251990|O2|Outcome|Deferred Treatment Group (DTG): Placebo > Grazoprevir/Elbasvir|Participants received a placebo tablet q.d. by mouth for 12 weeks (placebo treatment period). After a 4-week Follow-Up period, participants received open-label grazoprevir/elbasvir FDC during a 12-week Active Treatment period (Week 16 to Week 28). Participants were then followed-up for 24 weeks to Week 52.
53493|NCT02251990|O1|Outcome|Immediate Treatment Group (ITG): Grazoprevir/Elbasvir|Participants received a grazoprevir/elbasvir FDC tablet q.d. by mouth during a 12-week Active Treatment period (Week 1 to Week 12) and were followed-up for 24 weeks to Week 36.
53494|NCT02251990|E3|Reported Event|Deferred Treatment Group (DTG): Grazoprevir/Elbasvir|Participants received open-label grazoprevir/elbasvir FDC during a 12-week Active Treatment period (Week 16 to Week 28). Participants were then followed-up for 24 weeks to Week 52.
53495|NCT02251990|E2|Reported Event|Deferred Treatment Group (DTG): Placebo|Participants received a placebo tablet q.d. by mouth for 12 weeks during the double-blind treatment period (Weeks 1 to 12). Participants were then followed-up for 4 weeks to Week 16.
53496|NCT02251990|E1|Reported Event|Immediate Treatment Group (ITG): Grazoprevir/Elbasvir|Participants received a grazoprevir/elbasvir FDC tablet q.d. by mouth during a 12-week Active Treatment period (Week 1 to Week 12) and were followed-up for 24 weeks to Week 36
53497|NCT02251912|B3|Baseline|Total|Total of all reporting groups
53498|NCT02251912|B2|Baseline|Control|"Intranasal placebo doses 2-3 times/day for 12 weeks~Placebo: 10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks"
53499|NCT02251912|B1|Baseline|Active|"Intranasal oxytocin doses 2-3 times/day for 12 weeks~Intranasal Oxytocin: 10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks"
53500|NCT02251912|P2|Participant Flow|Control|"Intranasal placebo doses 2-3 times/day for 12 weeks~Placebo: 10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks"
53501|NCT02251912|P1|Participant Flow|Active|"Intranasal oxytocin doses 2-3 times/day for 12 weeks~Intranasal Oxytocin: 10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks"
53502|NCT02251912|O2|Outcome|Control|"Intranasal placebo doses 2-3 times/day for 12 weeks~Placebo: 10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks"
53503|NCT02251912|O1|Outcome|Active|"Intranasal oxytocin doses 2-3 times/day for 12 weeks~Intranasal Oxytocin: 10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks"
53504|NCT02251912|O2|Outcome|Control|"Intranasal placebo doses 2-3 times/day for 12 weeks~Placebo: 10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks"
53505|NCT02251912|O1|Outcome|Active|"Intranasal oxytocin doses 2-3 times/day for 12 weeks~Intranasal Oxytocin: 10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks"
53506|NCT02251912|O2|Outcome|Control|"Intranasal placebo doses 2-3 times/day for 12 weeks~Placebo: 10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks"
53507|NCT02251912|O1|Outcome|Active|"Intranasal oxytocin doses 2-3 times/day for 12 weeks~Intranasal Oxytocin: 10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks"
53508|NCT02251912|E2|Reported Event|Control|"Intranasal placebo doses 2-3 times/day for 12 weeks~Placebo: 10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks"
53509|NCT02251912|E1|Reported Event|Active|"Intranasal oxytocin doses 2-3 times/day for 12 weeks~Intranasal Oxytocin: 10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks"
53510|NCT02251886|B5|Baseline|Total|Total of all reporting groups
53511|NCT02251886|B4|Baseline|Control Multiparae|No intervention. Routine control schedule for multiparae with midwife
53512|NCT02251886|B3|Baseline|Control Primiparae|No intervention. Routine control schedule for primiparae with midwife
53513|NCT02251886|B2|Baseline|Moxibustion in Multiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae~Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
53514|NCT02251886|B1|Baseline|Moxibustion in Primiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae~Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
53515|NCT02251886|P4|Participant Flow|Control Multiparae|No intervention. Routine control schedule for multiparae with midwife
53516|NCT02251886|P3|Participant Flow|Control Primiparae|No intervention. Routine control schedule for primiparae with midwife
53517|NCT02251886|P2|Participant Flow|Moxibustion in Multiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae~Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
53518|NCT02251886|P1|Participant Flow|Moxibustion in Primiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae~Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
53519|NCT02251886|O4|Outcome|Control Multiparae|No intervention. Routine control schedule for multiparae with midwife
53520|NCT02251886|O3|Outcome|Control Primiparae|No intervention. Routine control schedule for primiparae with midwife
53521|NCT02251886|O2|Outcome|Moxibustion in Multiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae~Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
53522|NCT02251886|O1|Outcome|Moxibustion in Primiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae~Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
53523|NCT02251886|E4|Reported Event|Control Multiparae|No intervention. Routine control schedule for multiparae with midwife
53524|NCT02251886|E3|Reported Event|Control Primiparae|No intervention. Routine control schedule for primiparae with midwife
53525|NCT02251886|E2|Reported Event|Moxibustion in Multiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae~Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
53526|NCT02251886|E1|Reported Event|Moxibustion in Primiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae~Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
53527|NCT02251717|B3|Baseline|Total|Total of all reporting groups
53528|NCT02251717|B2|Baseline|LDV/SOF 24 Weeks|LDV/SOF (90/400 mg) for 24 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
53529|NCT02251717|B1|Baseline|LDV/SOF 12 Weeks|LDV/SOF (90/400 mg) for 12 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
53530|NCT02251717|P2|Participant Flow|LDV/SOF 24 Weeks|LDV/SOF (90/400 mg) for 24 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
53531|NCT02251717|P1|Participant Flow|LDV/SOF 12 Weeks|Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) for 12 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
53532|NCT02251717|O2|Outcome|LDV/SOF 24 Weeks|LDV/SOF (90/400 mg) for 24 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
53533|NCT02251717|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF (90/400 mg) for 12 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
53534|NCT02251717|O2|Outcome|LDV/SOF 24 Weeks|LDV/SOF (90/400 mg) for 24 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
53535|NCT02251717|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF (90/400 mg) for 12 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
53536|NCT02251717|O2|Outcome|LDV/SOF 24 Weeks|LDV/SOF (90/400 mg) for 24 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
53537|NCT02251717|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF (90/400 mg) for 12 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
53538|NCT02251717|O2|Outcome|LDV/SOF 24 Weeks|LDV/SOF (90/400 mg) for 24 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
53539|NCT02251717|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF (90/400 mg) for 12 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
53540|NCT02251717|E2|Reported Event|LDV/SOF 24 Weeks|LDV/SOF (90/400 mg) for 24 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
53541|NCT02251717|E1|Reported Event|LDV/SOF 12 Weeks|LDV/SOF (90/400 mg) for 12 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
53542|NCT02251652|B1|Baseline|Actinic Keratosis|Each subject is its own control - left dorsal hand compared to right dorsal hand
53543|NCT02251652|P1|Participant Flow|Actinic Keratosis|Each subject is its own control - left dorsal hand compared to right dorsal hand
53544|NCT02251652|O2|Outcome|Cryotherapy Alone|"Cryotherapy only~Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
53545|NCT02251652|O1|Outcome|Combination Therapy|"Cryotherapy followed by Ingenol Mebutate Gel~Ingenol Mebutate: Ingenol mebutate 0.05% gel~Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
53546|NCT02251652|O2|Outcome|Cryotherapy Alone|"Cryotherapy only~Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
53547|NCT02251652|O1|Outcome|Combination Therapy|"Cryotherapy followed by Ingenol Mebutate Gel~Ingenol Mebutate: Ingenol mebutate 0.05% gel~Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
53548|NCT02251652|O2|Outcome|Cryotherapy Alone|"Cryotherapy only~Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
53549|NCT02251652|O1|Outcome|Combination Therapy|"Cryotherapy followed by Ingenol Mebutate Gel~Ingenol Mebutate: Ingenol mebutate 0.05% gel~Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
53550|NCT02251652|E2|Reported Event|Cryotherapy Alone|"Cryotherapy only~Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
53551|NCT02251652|E1|Reported Event|Combination Therapy|"Cryotherapy followed by Ingenol Mebutate Gel~Ingenol Mebutate: Ingenol mebutate 0.05% gel~Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
53552|NCT02251613|B1|Baseline|Overall|Olopatadine HCl ophthalmic solution, 0.1%, and Epinastine HCl ophthalmic solution, 0.05%, administered contralaterally (1 drop in each eye), as randomized
53553|NCT02251613|P1|Participant Flow|Overall|Olopatadine HCl ophthalmic solution, 0.1%, and Epinastine HCl ophthalmic solution, 0.05%, administered contralaterally (1 drop in each eye), as randomized
53554|NCT02251613|O2|Outcome|Epinastine 0.05%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
53555|NCT02251613|O1|Outcome|Olopatadine 0.1%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
53556|NCT02251613|O2|Outcome|Epinastine 0.05%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
53557|NCT02251613|O1|Outcome|Olopatadine 0.1%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
53558|NCT02251613|E2|Reported Event|Epinastine 0.05%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
53559|NCT02251613|E1|Reported Event|Olopatadine 0.1%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
53560|NCT02251561|B1|Baseline|FID 109182/Opti-Free Plus|Senofilcon A contact lens pre-soaked in FID 109182 in 1 eye, with senofilcon A contact lens pre-soaked in Opti-Free Plus in the fellow eye. Lenses worn contralaterally for 2 hours.
53561|NCT02251561|P1|Participant Flow|FID 109182/Opti-Free Plus|Senofilcon A contact lens pre-soaked in FID 109182 in 1 eye, with senofilcon A contact lens pre-soaked in Opti-Free Plus in the fellow eye. Lenses worn contralaterally for 2 hours.
53562|NCT02251561|O2|Outcome|Opti-Free Plus|Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours
53563|NCT02251561|O1|Outcome|FID 109182|Senofilcon A contact lens pre-soaked in FID 109182 worn in 1 eye for 2 hours
53564|NCT02251561|O2|Outcome|Opti-Free Plus|Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours
53565|NCT02251561|O1|Outcome|FID 109182|Senofilcon A contact lens pre-soaked in FID 109182 worn in 1 eye for 2 hours
53566|NCT02251561|E2|Reported Event|Opti-Free Plus|Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours
53567|NCT02251561|E1|Reported Event|FID 109182|Senofilcon A contact lens pre-soaked in FID 109182 worn in 1 eye for 2 hours
53568|NCT02250807|B1|Baseline|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
53569|NCT02250807|P1|Participant Flow|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
53570|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
53571|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
53572|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
53573|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
53574|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
53575|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
53576|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
53577|NCT02250807|E1|Reported Event|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
53578|NCT02250703|B3|Baseline|Total|Total of all reporting groups
53579|NCT02250703|B2|Baseline|Dexmedetomidine|"In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).~Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg"
53580|NCT02250703|B1|Baseline|Midazolam|"In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication~Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg"
53581|NCT02250703|P2|Participant Flow|Dexmedetomidine|"In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).~Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg"
53582|NCT02250703|P1|Participant Flow|Midazolam|"In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication~Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg"
53629|NCT02249819|O1|Outcome|Anodal tDCS|Participants received 1 single 20 min session of anodal tDCS + computerized naming therapy in either the first two or the last two weeks of the study.
53583|NCT02250703|O2|Outcome|Dexmedetomidine|"In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).~Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg"
53584|NCT02250703|O1|Outcome|Midazolam|"In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication~Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg"
53585|NCT02250703|O2|Outcome|Dexmedetomidine|"In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).~Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg"
53586|NCT02250703|O1|Outcome|Midazolam|"In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication~Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg"
53587|NCT02250703|O2|Outcome|Dexmedetomidine|"In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).~Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg"
53588|NCT02250703|O1|Outcome|Midazolam|"In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication~Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg"
53589|NCT02250703|O2|Outcome|Dexmedetomidine|"In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).~Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg"
53590|NCT02250703|O1|Outcome|Midazolam|"In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication~Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg"
53591|NCT02250703|E2|Reported Event|Dexmedetomidine|"In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).~Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg"
53592|NCT02250703|E1|Reported Event|Midazolam|"In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication~Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg"
53593|NCT02250443|B1|Baseline|BYM338|BYM338 Group
53594|NCT02250443|P1|Participant Flow|BYM338|BYM338 Group
53595|NCT02250443|O1|Outcome|BYM338|BYM338 Group
53596|NCT02250443|O1|Outcome|BYM338|BYM338 Group
53597|NCT02250443|O1|Outcome|BYM338|BYM338 Group
53598|NCT02250443|O1|Outcome|BYM338|BYM338 Group
53599|NCT02250443|O1|Outcome|BYM338|BYM338 Group
53600|NCT02250443|O1|Outcome|BYM338|BYM338 Group
53601|NCT02250443|O1|Outcome|BYM338|BYM338 Group
53602|NCT02250443|O1|Outcome|BYM338|BYM338 Group
53603|NCT02250443|O1|Outcome|BYM338|BYM338 Group
53604|NCT02250443|O1|Outcome|BYM338|BYM338 Group
53605|NCT02250443|E1|Reported Event|BYM338 10mg/kg i.v.|BYM338 10mg/kg i.v.
53606|NCT02250274|B3|Baseline|Total|Total of all reporting groups
53607|NCT02250274|B2|Baseline|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.~IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.~[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
53608|NCT02250274|B1|Baseline|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.~LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
53609|NCT02250274|P2|Participant Flow|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.~IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.~[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
53610|NCT02250274|P1|Participant Flow|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.~LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
53630|NCT02249819|E2|Reported Event|Sham tDCS|Participants who received sham tDCS + computerized picture-naming therapy, and were followed for 2 weeks.
53631|NCT02249819|E1|Reported Event|Anodal tDCS|Participants who received anodal tDCS + computerized picture-naming therapy, and were followed for 2 weeks.
53729|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
53611|NCT02250274|O2|Outcome|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.~IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.~[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
53612|NCT02250274|O1|Outcome|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.~LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
53613|NCT02250274|O6|Outcome|Unvax-LAIV|Participants unvaccinated in 2013-14 and receiving LAIV in 2014-15.
53614|NCT02250274|O5|Outcome|Unvax-IIV|Participants unvaccinated in 2013-14 and receiving IIV in 2014-15.
53615|NCT02250274|O4|Outcome|LAIV-LAIV|Participants receiving LAIV in 2013-14 and LAIV in 2014-15.
53616|NCT02250274|O3|Outcome|LAIV-IIV|Participants receiving LAIV in 2013-14 and IIV in 2014-15.
53617|NCT02250274|O2|Outcome|IIV-LAIV|Participants receiving IIV in 2013-14 and LAIV in 2014-15.
53618|NCT02250274|O1|Outcome|IIV-IIV|Participants receiving IIV in 2013-14 and IIV again in 2014-15.
53619|NCT02250274|O2|Outcome|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.~IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.~[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
53620|NCT02250274|O1|Outcome|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.~LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
53621|NCT02250274|O2|Outcome|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.~IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.~[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
53622|NCT02250274|O1|Outcome|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.~LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
53623|NCT02250274|E2|Reported Event|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.~IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.~[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
53624|NCT02250274|E1|Reported Event|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.~LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
53625|NCT02249819|B1|Baseline|All Study Participants|Crossover design study: All participants were randomized to receive one single 20 min session of anodal tDCS and 1 single session of sham tDCS followed by computerized naming therapy. Sequence of stimulation conditions was counterbalanced across participants with a 1 week washout period in between conditions.
53626|NCT02249819|P2|Participant Flow|Sham tDCS, Then Anodal tDCS|Participants first received 1 single 20 min session of sham tDCS + computerized naming therapy. After a washout period of 1 week, they then received 1 single 20 min session of anodal tDCS + computerized naming therapy.
53627|NCT02249819|P1|Participant Flow|Anodal tDCS, Then Sham tDCS|Participants first received 1 single 20 min session of anodal tDCS + computerized naming therapy. After a washout period of 1 week, they then received 1 single 20 min session of sham tDCS + computerized naming therapy.
53628|NCT02249819|O2|Outcome|Sham tDCS|Participants received 1 single 20 min session of sham tDCS + computerized naming therapy in either the first two or the last two weeks of the study.
53715|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
53632|NCT02249728|B1|Baseline|All Study Participants|In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Following completion of Part One, participants crossed over into Part Two (Radiolabelled AME), where a single dose of oral PBT2 250 mg 14C suspension was administered.
53633|NCT02249728|P1|Participant Flow|All Study Participants|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
53634|NCT02249728|O1|Outcome|Part Two Radiolabelle AME|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
53635|NCT02249728|O1|Outcome|Part Two Radiolabelled AME|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
53636|NCT02249728|O1|Outcome|All Study Participants|In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Following completion of Part One, participants crossed over into Part Two (Radiolabelled AME), where a single dose of oral PBT2 250 mg 14C suspension was administered.
53637|NCT02249728|O1|Outcome|Part One Absolute Bioavailability|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
53638|NCT02249728|O1|Outcome|Part Two Radiolabelled AME|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
53639|NCT02249728|O1|Outcome|Part Two Radiolabelled AME|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
53640|NCT02249728|O1|Outcome|Part One Absolute Bioavailability|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
53641|NCT02249728|E1|Reported Event|All Study Participants|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
53642|NCT02249104|B1|Baseline|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
53643|NCT02249104|P1|Participant Flow|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
53644|NCT02249104|O1|Outcome|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
53645|NCT02249104|O1|Outcome|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
53646|NCT02249104|O1|Outcome|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
53647|NCT02249104|O1|Outcome|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
53648|NCT02249104|O1|Outcome|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
53649|NCT02249104|O1|Outcome|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
53716|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
53717|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
53718|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
53650|NCT02249104|E1|Reported Event|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
53651|NCT02249065|B1|Baseline|Mirvaso Gel|Brimonidine Gel
53652|NCT02249065|P1|Participant Flow|Mirvaso Gel|Brimonidine Gel (topical emulsion (gel), 0.33% brimonidine, once daily)
53653|NCT02249065|O1|Outcome|Mirvaso Gel|Brimonidine Gel
53654|NCT02249065|O1|Outcome|Mirvaso Gel|Brimonidine Gel
53655|NCT02249065|O1|Outcome|Mirvaso Gel|Brimonidine Gel
53656|NCT02249065|O1|Outcome|Mirvaso Gel|Brimonidine Gel
53657|NCT02249065|O1|Outcome|Mirvaso Gel|Brimonidine Gel
53658|NCT02249065|E1|Reported Event|Mirvaso Gel|Brimonidine Gel
53659|NCT02249052|B1|Baseline|AA4500 and Placebo|"single injection of 0.58 mg study drug and placebo~Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously"
53660|NCT02249052|P1|Participant Flow|AA4500 and Placebo|"Each subject received a single injection of 1 mL containing 0.58 mg AA4500 in one lipoma and a single injection of 1 mL placebo in another lipoma~Lipoma #1 was randomized to AA4500 or placebo with Lipoma #2 receiving the alternate intervention"
53661|NCT02249052|O2|Outcome|Placebo|Each participant received a single injection of 1 mL placebo
53662|NCT02249052|O1|Outcome|AA4500|Each participants received a single injection of 1 mL containing 0.58 mg AA4500
53663|NCT02249052|O2|Outcome|Placebo|Each subject received a single injection of 1 mL placebo
53664|NCT02249052|O1|Outcome|AA4500|Each subject received a single injection of 1 mL containing 0.58 mg AA4500
53665|NCT02249052|O2|Outcome|Placebo|Each subject received a single injection of 1 mL placebo
53666|NCT02249052|O1|Outcome|AA4500|Each subject received a single injection of 1 mL containing 0.58 mg AA4500
53667|NCT02249052|O2|Outcome|Placebo|Each participant received a single injection of 1 mL placebo
53668|NCT02249052|O1|Outcome|AA4500|Each participants received a single injection of 1 mL containing 0.58 mg AA4500
53669|NCT02249052|O2|Outcome|Placebo|Each subject received a single injection of 1 mL placebo
53670|NCT02249052|O1|Outcome|AA4500|Each subject received a single injection of 1 mL containing 0.58 mg AA4500
53671|NCT02249052|O2|Outcome|Placebo|Each subject received a single injection of 1 mL placebo
53672|NCT02249052|O1|Outcome|AA4500|Each subject received a single injection of 1 mL containing 0.58 mg AA4500
53673|NCT02249052|E2|Reported Event|Placebo|"single injection of placebo~placebo: Placebo"
53674|NCT02249052|E1|Reported Event|AA4500|"single injection of 0.58 mg study drug~AA4500: Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously"
53675|NCT02248818|B9|Baseline|Total|Total of all reporting groups
53676|NCT02248818|B8|Baseline|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
53677|NCT02248818|B7|Baseline|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
53678|NCT02248818|B6|Baseline|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
53679|NCT02248818|B5|Baseline|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
53680|NCT02248818|B4|Baseline|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
53681|NCT02248818|B3|Baseline|AZD8108 95 mg - SAD|AZD8108 95 mg SAD, Cohort 3
53682|NCT02248818|B2|Baseline|AZD8108 60 mg - SAD|AZD8108 60 mg SAD, Cohort 2
53683|NCT02248818|B1|Baseline|AZD8108 20 mg - SAD|AZD8108 20 mg SAD, Cohort 1
53684|NCT02248818|P9|Participant Flow|Screen|Screen - no treatment
53685|NCT02248818|P8|Participant Flow|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
53686|NCT02248818|P7|Participant Flow|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
53687|NCT02248818|P6|Participant Flow|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
53688|NCT02248818|P5|Participant Flow|AZD8108 50 mg|AZD8108 50 mg MAD, Cohort 5
53689|NCT02248818|P4|Participant Flow|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
53690|NCT02248818|P3|Participant Flow|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
53691|NCT02248818|P2|Participant Flow|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
53692|NCT02248818|P1|Participant Flow|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
53693|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
53694|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
53695|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
53696|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
53697|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
53698|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
53699|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
53700|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
53701|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
53702|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
53703|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
53704|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
53705|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
53706|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
53707|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
53708|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
53709|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
53710|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
53711|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
53712|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
53713|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
53714|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
53730|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
53731|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
53732|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
53733|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
53734|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
53735|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
53736|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
53737|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
53738|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
53739|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
53740|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
53741|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
53742|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
53743|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
53744|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
53745|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
53746|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
53747|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
53748|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
53749|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
53750|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
53751|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
53752|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
53753|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
53754|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
53755|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
53756|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
53757|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
53758|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
53759|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
53760|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
53761|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
53762|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
53763|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
53764|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
53765|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
53766|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
53767|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
53768|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
53769|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
53770|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
53771|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
53772|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
53773|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
53774|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
53775|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
53776|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
53777|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
53778|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
53779|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
53780|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
53781|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
53782|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
53783|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
53784|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
53785|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
53786|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
53787|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
53788|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
53789|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
53790|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
53791|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
53792|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
53793|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
53794|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
53795|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
53796|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
53797|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
53798|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
53799|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
53800|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
53801|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
53802|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
53803|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
53804|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
53805|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
53806|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
53807|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
53808|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
53809|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
53810|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
53811|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
53812|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
53813|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
53814|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
53815|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
53816|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
53817|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
53818|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
53819|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
53820|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
53821|NCT02248818|E8|Reported Event|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
53822|NCT02248818|E7|Reported Event|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
53823|NCT02248818|E6|Reported Event|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
53824|NCT02248818|E5|Reported Event|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
53825|NCT02248818|E4|Reported Event|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
53826|NCT02248818|E3|Reported Event|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
53827|NCT02248818|E2|Reported Event|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
53828|NCT02248818|E1|Reported Event|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
53829|NCT02248766|B1|Baseline|Enfilcon A / Somofilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens~somofilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
53830|NCT02248766|P1|Participant Flow|Enfilcon A / Somofilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens~somofilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
53831|NCT02248766|O4|Outcome|Somofilcon A at 4 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
53832|NCT02248766|O3|Outcome|Somofilcon A at 2 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
53833|NCT02248766|O2|Outcome|Somofilcon A at 1 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
53834|NCT02248766|O1|Outcome|Enfilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
53835|NCT02248766|O4|Outcome|Somofilcon A at 4 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
53836|NCT02248766|O3|Outcome|Somofilcon A at 2 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
53837|NCT02248766|O2|Outcome|Somofilcon A at 1 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
53838|NCT02248766|O1|Outcome|Enfilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
53839|NCT02248766|E2|Reported Event|Somofilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~somofilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
53840|NCT02248766|E1|Reported Event|Enfilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
53841|NCT02248727|B1|Baseline|Enfilcon A / Somofilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~somofilcon A: All participants wear habitual enfilcon A lens first then refitted with somofilcon A lens"
53842|NCT02248727|P1|Participant Flow|Enfilcon A / Somofilcon A|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
53843|NCT02248727|O4|Outcome|Somofilcon A at 4 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
53844|NCT02248727|O3|Outcome|Somofilcon A at 2 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
53845|NCT02248727|O2|Outcome|Somofilcon A at 1 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
53846|NCT02248727|O1|Outcome|Enfilcon A|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
53847|NCT02248727|O4|Outcome|Somofilcon A at 4 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
53848|NCT02248727|O3|Outcome|Somofilcon A at 2 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
53849|NCT02248727|O2|Outcome|Somofilcon A at 1 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
53850|NCT02248727|O1|Outcome|Enfilcon A|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
53851|NCT02248727|E1|Reported Event|Enfilcon A to Somofilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~somofilcon A: All participants wear habitual enfilcon A lens first then refitted with somofilcon A lens"
53853|NCT02248675|B2|Baseline|TAU Control|"Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
53854|NCT02248675|B1|Baseline|CBT-I + TAU|"Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).~CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
53855|NCT02248675|P2|Participant Flow|TAU Control|"Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
53856|NCT02248675|P1|Participant Flow|CBT-I + TAU|"Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).~CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
53857|NCT02248675|O2|Outcome|TAU Control|"Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
53858|NCT02248675|O1|Outcome|CBT-I + TAU|"Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).~CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
53859|NCT02248675|O2|Outcome|TAU Control|"Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
53860|NCT02248675|O1|Outcome|CBT-I + TAU|"Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).~CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
53874|NCT02248558|O2|Outcome|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.~Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos."
53875|NCT02248558|O1|Outcome|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.~Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development."
53861|NCT02248675|O2|Outcome|TAU Control|"Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
53862|NCT02248675|O1|Outcome|CBT-I + TAU|"Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).~CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
53863|NCT02248675|O2|Outcome|TAU Control|"Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
53864|NCT02248675|O1|Outcome|CBT-I + TAU|"Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).~CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
53865|NCT02248675|E2|Reported Event|TAU Control|"Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
53866|NCT02248675|E1|Reported Event|CBT-I + TAU|"Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).~CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
53867|NCT02248558|B3|Baseline|Total|Total of all reporting groups
53868|NCT02248558|B2|Baseline|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.~Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos."
53869|NCT02248558|B1|Baseline|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.~Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development."
53870|NCT02248558|P2|Participant Flow|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.~Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos."
53871|NCT02248558|P1|Participant Flow|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.~Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development."
53872|NCT02248558|O2|Outcome|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.~Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.~In the crowdsourced intervention arm, 114 of 307 (37%) reported testing for HIV."
53873|NCT02248558|O1|Outcome|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.~Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.~111 of 317 (35%) in the health marketing arm reported testing for HIV"
53876|NCT02248558|O2|Outcome|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.~Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.~In the crowdsourced intervention arm, 114 of 307 (37%) reported testing for HIV."
53877|NCT02248558|O1|Outcome|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.~Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.~111 of 317 (35%) in the health marketing arm reported testing for HIV"
53878|NCT02248558|E2|Reported Event|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.~Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos."
53879|NCT02248558|E1|Reported Event|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.~Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development."
53880|NCT02248480|B3|Baseline|Total|Total of all reporting groups
53881|NCT02248480|B2|Baseline|Placebo|Placebo administered orally once a day for 15 weeks.
53882|NCT02248480|B1|Baseline|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
53883|NCT02248480|P2|Participant Flow|Placebo|Placebo administered orally once a day for 15 weeks.
53884|NCT02248480|P1|Participant Flow|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
53885|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
53886|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
53887|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
53888|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
53889|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
53890|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
53891|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
53892|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
53893|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
53894|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
53895|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
53896|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
53897|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
53898|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
53899|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
53900|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
53901|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
53902|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
53903|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
53904|NCT02248480|O1|Outcome|Duloxetine|"Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.~Duloxetine: Administered orally"
53905|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
53906|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
53907|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
53908|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
53909|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
53910|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
53911|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
53912|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
53913|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
53914|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
53915|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
53916|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
53917|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
53918|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
53919|NCT02248480|E2|Reported Event|Placebo|Placebo administered orally once a day for 15 weeks.
53920|NCT02248480|E1|Reported Event|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
53921|NCT02248285|B3|Baseline|Total|Total of all reporting groups
53922|NCT02248285|B2|Baseline|Pre-intervention|Testing will be at the discretion of the clinician using standard laboratory tests, and specimens will be collected as appropriate for these methods.
53923|NCT02248285|B1|Baseline|Intervention|"FilmArray™ GI Panel testing will be standard of care and provided at no cost. Additional testing may be ordered at the discretion of the clinician.~FilmArray™ Gastrointestinal (GI) Panel: BioFire Diagnostics, LLC (BioFire) has developed a polymerase chain reaction (PCR), high-resolution melting analysis instrument called the FilmArray™ and an associated reagent pouch that together are capable of simultaneously detecting multiple microorganisms in a single sample. The FilmArray™ Gastrointestinal (GI) Panel pouch contains freeze-dried reagents to perform nucleic acid purification and nested, multiplex PCR for the identification of common bacterial, viral, and parasite microorganisms responsible for infectious gastroenteritis. The test was made available for sale in the US and EU following FDA clearance and CE marking in May, 2014"
53924|NCT02248285|P2|Participant Flow|Pre-intervention|Testing will be at the discretion of the clinician using standard laboratory tests, and specimens will be collected as appropriate for these methods.
53925|NCT02248285|P1|Participant Flow|Intervention|"FilmArray™ GI Panel testing will be standard of care and provided at no cost. Additional testing may be ordered at the discretion of the clinician.~FilmArray™ Gastrointestinal (GI) Panel: BioFire Diagnostics, LLC (BioFire) has developed a polymerase chain reaction (PCR), high-resolution melting analysis instrument called the FilmArray™ and an associated reagent pouch that together are capable of simultaneously detecting multiple microorganisms in a single sample. The FilmArray™ Gastrointestinal (GI) Panel pouch contains freeze-dried reagents to perform nucleic acid purification and nested, multiplex PCR for the identification of common bacterial, viral, and parasite microorganisms responsible for infectious gastroenteritis. The test was made available for sale in the US and EU following FDA clearance and CE marking in May, 2014"
53926|NCT02248285|O2|Outcome|Pre-intervention|Testing will be at the discretion of the clinician using standard laboratory tests, and specimens will be collected as appropriate for these methods.
53927|NCT02248285|O1|Outcome|Intervention|"FilmArray™ GI Panel testing will be standard of care and provided at no cost. Additional testing may be ordered at the discretion of the clinician.~FilmArray™ Gastrointestinal (GI) Panel: BioFire Diagnostics, LLC (BioFire) has developed a polymerase chain reaction (PCR), high-resolution melting analysis instrument called the FilmArray™ and an associated reagent pouch that together are capable of simultaneously detecting multiple microorganisms in a single sample. The FilmArray™ Gastrointestinal (GI) Panel pouch contains freeze-dried reagents to perform nucleic acid purification and nested, multiplex PCR for the identification of common bacterial, viral, and parasite microorganisms responsible for infectious gastroenteritis. The test was made available for sale in the US and EU following FDA clearance and CE marking in May, 2014"
53928|NCT02248285|E2|Reported Event|Pre-intervention|Testing will be at the discretion of the clinician using standard laboratory tests, and specimens will be collected as appropriate for these methods.
53929|NCT02248285|E1|Reported Event|Intervention|"FilmArray™ GI Panel testing will be standard of care and provided at no cost. Additional testing may be ordered at the discretion of the clinician.~FilmArray™ Gastrointestinal (GI) Panel: BioFire Diagnostics, LLC (BioFire) has developed a polymerase chain reaction (PCR), high-resolution melting analysis instrument called the FilmArray™ and an associated reagent pouch that together are capable of simultaneously detecting multiple microorganisms in a single sample. The FilmArray™ Gastrointestinal (GI) Panel pouch contains freeze-dried reagents to perform nucleic acid purification and nested, multiplex PCR for the identification of common bacterial, viral, and parasite microorganisms responsible for infectious gastroenteritis. The test was made available for sale in the US and EU following FDA clearance and CE marking in May, 2014"
53930|NCT02248246|B1|Baseline|Colectomy With Harmonic ACE®+7 Shears|"Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection~Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:~Inferior mesenteric artery (IMA)~Inferior mesenteric vein (IMV) (if identified)"
53931|NCT02248246|P1|Participant Flow|Colectomy With Harmonic ACE®+7 Shears|"Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection~Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:~Inferior mesenteric artery (IMA)~Inferior mesenteric vein (IMV) (if identified)"
53932|NCT02248246|O1|Outcome|Colectomy With Harmonic ACE®+7 Shears|"Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection~Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:~Inferior mesenteric artery (IMA)~Inferior mesenteric vein (IMV) (if identified)"
53933|NCT02248246|O1|Outcome|Colectomy With Harmonic ACE®+7 Shears|"Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection~Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:~Inferior mesenteric artery (IMA)~Inferior mesenteric vein (IMV) (if identified)"
53979|NCT02247739|O2|Outcome|rhC1INH Once Weekly|"rhC1INH administered once weekly~Recombinant human C1 inhibitor"
53980|NCT02247739|O1|Outcome|rhC1INH Twice Weekly|"rhC1INH administered twice weekly~Recombinant human C1 inhibitor"
87168|NCT02040792|P3|Participant Flow|88 mcg|"TD-4208~TD-4208"
53934|NCT02248246|E1|Reported Event|Colectomy With Harmonic ACE®+7 Shears|"Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection~Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:~Inferior mesenteric artery (IMA)~Inferior mesenteric vein (IMV) (if identified)"
53935|NCT02248103|B3|Baseline|Total|Total of all reporting groups
53936|NCT02248103|B2|Baseline|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane~Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
53937|NCT02248103|B1|Baseline|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.~Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
53938|NCT02248103|P2|Participant Flow|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane~Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
53939|NCT02248103|P1|Participant Flow|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.~Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
53940|NCT02248103|O2|Outcome|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane~Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
53941|NCT02248103|O1|Outcome|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.~Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
53942|NCT02248103|O2|Outcome|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane~Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
53943|NCT02248103|O1|Outcome|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.~Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
53944|NCT02248103|O2|Outcome|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane~Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
53945|NCT02248103|O1|Outcome|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.~Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
53946|NCT02248103|E2|Reported Event|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane~Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
53947|NCT02248103|E1|Reported Event|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.~Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
53948|NCT02247960|B3|Baseline|Total|Total of all reporting groups
53949|NCT02247960|B2|Baseline|No Antibiotic|No Antibiotic
53950|NCT02247960|B1|Baseline|Ciprofloxacin|"Antibiotic~Ciprofloxacin"
53951|NCT02247960|P2|Participant Flow|No Antibiotic|No Antibiotic
53952|NCT02247960|P1|Participant Flow|Ciprofloxacin|"Antibiotic~Ciprofloxacin"
53953|NCT02247960|O2|Outcome|No Antibiotic|No Antibiotic
53954|NCT02247960|O1|Outcome|Ciprofloxacin|"Antibiotic~Ciprofloxacin"
53955|NCT02247960|O2|Outcome|No Antibiotic|No Antibiotic
53956|NCT02247960|O1|Outcome|Ciprofloxacin|"Antibiotic~Ciprofloxacin"
53957|NCT02247960|O2|Outcome|No Antibiotic|No Antibiotic
53958|NCT02247960|O1|Outcome|Ciprofloxacin|"Antibiotic~Ciprofloxacin"
53959|NCT02247960|E2|Reported Event|No Antibiotic|No Antibiotic
53960|NCT02247960|E1|Reported Event|Ciprofloxacin|"Antibiotic~Ciprofloxacin"
53961|NCT02247765|B1|Baseline|no Treatment|
53962|NCT02247765|P1|Participant Flow|USB Pulse Oximetry Monitor Interface Cable|"Additional interventions include the following: Radial Arterial Line placement involves introduction of a standard arterial catheter or angiocath into the radial artery. Since the arterial catheter is placed into the artery using a needle, there will be mild to moderate discomfort. The total amount of blood drawn during the procedure is less than 100cc.~Additionally, subjects are asked to perform motions with their hand. Standard motions include tapping and rubbing at aperiodic intervals with amplitudes of 1‐2 cm and 1‐4 Hz with a random variation in frequency. The subject is instructed to tap (or rub) with finger tips to maintain consistency of area of effect on the pressure pad and to prevent resting hand on pressure pad between motions so that only qualified taps are recorded by the pressure pad system. Each plateau will have both an interval of tapping and rubbing."
53963|NCT02247765|O1|Outcome|no Treatment|
53964|NCT02247765|O1|Outcome|no Treatment|
53965|NCT02247765|E1|Reported Event|no Treatment|
53966|NCT02247739|B1|Baseline|All Study Participants|All randomized patients
53967|NCT02247739|P6|Participant Flow|Treatment Sequence F|rhC1INH once weekly / saline / rhC1INH twice weekly
53968|NCT02247739|P5|Participant Flow|Treatment Sequence E|rhC1INH twice weekly / saline / rhC1INH once weekly
53969|NCT02247739|P4|Participant Flow|Treatment Sequence D|Saline / rhC1INH twice weekly / rhC1INH once weekly
53970|NCT02247739|P3|Participant Flow|Treatment Sequesce C|Saline / rhC1INH once weekly / rhC1INH twice weekly
53971|NCT02247739|P2|Participant Flow|Treatments Sequence B|rhC1INH once weekly / rhC1INH twice weekly / Saline
53972|NCT02247739|P1|Participant Flow|Treatment Sequence A|rhC1INH twice weekly / rhC1INH once weekly / saline
53973|NCT02247739|O3|Outcome|Placebo (Saline) Twice Weekly|"Placebo (Saline) administered twice weekly~Placebo"
53974|NCT02247739|O2|Outcome|rhC1INH Once Weekly|"rhC1INH administered once weekly~Recombinant human C1 inhibitor"
53975|NCT02247739|O1|Outcome|rhC1INH Twice Weekly|"rhC1INH administered twice weekly~Recombinant human C1 inhibitor"
53976|NCT02247739|O2|Outcome|rhC1INH Once Weekly|rhC1INH administered once weekly
53977|NCT02247739|O1|Outcome|rhC1INH Twice Weekly|rhC1INH administered twice weekly
53978|NCT02247739|O3|Outcome|Placebo (Saline) Twice Weekly|"Placebo (Saline) administered twice weekly~Placebo"
53981|NCT02247739|O3|Outcome|Placebo (Saline) Twice Weekly|"Placebo (Saline) administered twice weekly~Placebo"
53982|NCT02247739|O2|Outcome|rhC1INH Once Weekly|"rhC1INH administered once weekly~Recombinant human C1 inhibitor"
53983|NCT02247739|O1|Outcome|rhC1INH Twice Weekly|"rhC1INH administered twice weekly~Recombinant human C1 inhibitor"
53984|NCT02247739|E3|Reported Event|Placebo (Saline) Twice Weekly|"Placebo (Saline) administered twice weekly~Placebo"
53985|NCT02247739|E2|Reported Event|rhC1INH Once Weekly|"rhC1INH administered once weekly~Recombinant human C1 inhibitor"
53986|NCT02247739|E1|Reported Event|rhC1INH Twice Weekly|"rhC1INH administered twice weekly~Recombinant human C1 inhibitor"
53987|NCT02247401|B4|Baseline|Total|Total of all reporting groups
53988|NCT02247401|B3|Baseline|Arm C|ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
53989|NCT02247401|B2|Baseline|Arm B|ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
53990|NCT02247401|B1|Baseline|Arm A|ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 DAA) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.
53991|NCT02247401|P3|Participant Flow|Arm C|ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
53992|NCT02247401|P2|Participant Flow|Arm B|ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
53993|NCT02247401|P1|Participant Flow|Arm A|ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 DAA) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.
53994|NCT02247401|O3|Outcome|Arm C|ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
53995|NCT02247401|O2|Outcome|Arm B|ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
53996|NCT02247401|O1|Outcome|Arm A|ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 direct acting antiviral agent [DAA]) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.
53997|NCT02247401|O3|Outcome|Arm C|ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
53998|NCT02247401|O2|Outcome|Arm B|ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
53999|NCT02247401|O1|Outcome|Arm A|ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 direct acting antiviral agent [DAA]) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.
54000|NCT02247401|O3|Outcome|Arm C|ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
54001|NCT02247401|O2|Outcome|Arm B|ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
54002|NCT02247401|O1|Outcome|Arm A|ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 DAA) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.
54003|NCT02247401|O3|Outcome|Arm C|ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
54004|NCT02247401|O2|Outcome|Arm B|ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
54005|NCT02247401|O1|Outcome|Arm A|ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 DAA) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.
54006|NCT02247401|E3|Reported Event|Arm C|ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
54007|NCT02247401|E2|Reported Event|Arm B|ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
54008|NCT02247401|E1|Reported Event|Arm A|ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 DAA) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.
54009|NCT02247063|B3|Baseline|Total|Total of all reporting groups
54010|NCT02247063|B2|Baseline|Experimental|"The subjects in the experimental arm will participate in 5 daily sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Then 2mA of transcranial direct current stimulation will be applied for 20 minutes.~High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain."
54011|NCT02247063|B1|Baseline|Placebo|"The subjects in the placebo arm will participate in 5 daily M1 High-Definition Transcranial Direct Current Stimulation (HD-tDCS) sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Current will be applied only for 30 seconds – this is a reliable method of sham stimulation (Gandiga et al., 2006) as sensations arising from tDCS treatment occur only at the beginning of application.~High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain."
54083|NCT02246998|O3|Outcome|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54012|NCT02247063|P2|Participant Flow|Experimental|"The subjects in the experimental arm will participate in 5 daily sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Then 2mA of transcranial direct current stimulation will be applied for 20 minutes.~High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain."
54013|NCT02247063|P1|Participant Flow|Placebo|"The subjects in the placebo arm will participate in 5 daily M1 High-Definition Transcranial Direct Current Stimulation (HD-tDCS) sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Current will be applied only for 30 seconds – this is a reliable method of sham stimulation (Gandiga et al., 2006) as sensations arising from tDCS treatment occur only at the beginning of application.~High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain."
54014|NCT02247063|O2|Outcome|Experimental|"The subjects in the experimental arm will participate in 5 daily sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Then 2mA of transcranial direct current stimulation will be applied for 20 minutes.~High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain."
54015|NCT02247063|O1|Outcome|Placebo|"The subjects in the placebo arm will participate in 5 daily M1 High-Definition Transcranial Direct Current Stimulation (HD-tDCS) sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Current will be applied only for 30 seconds – this is a reliable method of sham stimulation (Gandiga et al., 2006) as sensations arising from tDCS treatment occur only at the beginning of application.~High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain."
54016|NCT02247063|O2|Outcome|Experimental|"The subjects in the experimental arm will participate in 5 daily sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Then 2mA of transcranial direct current stimulation will be applied for 20 minutes.~High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain."
54017|NCT02247063|O1|Outcome|Placebo|"The subjects in the placebo arm will participate in 5 daily M1 High-Definition Transcranial Direct Current Stimulation (HD-tDCS) sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Current will be applied only for 30 seconds – this is a reliable method of sham stimulation (Gandiga et al., 2006) as sensations arising from tDCS treatment occur only at the beginning of application.~High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain."
54018|NCT02247063|E2|Reported Event|Experimental|"The subjects in the experimental arm will participate in 5 daily sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Then 2mA of transcranial direct current stimulation will be applied for 20 minutes.~High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain."
54019|NCT02247063|E1|Reported Event|Placebo|"The subjects in the placebo arm will participate in 5 daily M1 High-Definition Transcranial Direct Current Stimulation (HD-tDCS) sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Current will be applied only for 30 seconds – this is a reliable method of sham stimulation (Gandiga et al., 2006) as sensations arising from tDCS treatment occur only at the beginning of application.~High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain."
54020|NCT02247011|B3|Baseline|Total|Total of all reporting groups
54021|NCT02247011|B2|Baseline|Non-fracture Group|Non-fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
54022|NCT02247011|B1|Baseline|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
54023|NCT02247011|P1|Participant Flow|Overall Subjects|In 2007-2008, 2070 postmenopausal women participated in the previous PK-VF study. After 5 years, 1100 subjects agreed to be re-evaluated in 2013. Questionnaires and blood samples were collected, and BMD and spine x-ray were obtained from these 1100 participants.
54024|NCT02247011|O2|Outcome|Non-fracture Group|Non-fracture Group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
54025|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
54026|NCT02247011|O2|Outcome|Non-fracture Group|Non-fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
54027|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
54028|NCT02247011|O2|Outcome|Non-fracture Group|Fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
54029|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
54030|NCT02247011|O2|Outcome|Non-fracture Group|Non-fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
54031|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
54032|NCT02247011|O2|Outcome|Non-fracture Group|Non-fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
54033|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
54034|NCT02247011|O2|Outcome|Non-fracture Group|Non-fracture Group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
54035|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
54036|NCT02247011|O2|Outcome|Non-fracture Group|Non-fracture Group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
54037|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
54038|NCT02247011|E1|Reported Event|Overall Subjects|In 2007-2008, 2070 postmenopausal women participated in the previous PK-VF study. After 5 years, 1100 subjects agreed to be re-evaluated in 2013. Questionnaires and blood samples were collected, and BMD and spine x-ray were obtained from these 1100 participants. Of all these participants, 975 participants finished the questionnaire and for 961 of them, the spine x-ray was of enough quality to determine if there is vertebral fracture.
54039|NCT02246998|B5|Baseline|Total|Total of all reporting groups
54040|NCT02246998|B4|Baseline|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54041|NCT02246998|B3|Baseline|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54042|NCT02246998|B2|Baseline|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54043|NCT02246998|B1|Baseline|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54044|NCT02246998|P4|Participant Flow|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54045|NCT02246998|P3|Participant Flow|ATR + Iohexol|EFV/FTC/TDF (ATR; Atripla® 600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54046|NCT02246998|P2|Participant Flow|TVD + ATV/r + Iohexol|FTC/TDF (TVD; Truvada®; 200/300 mg) FDC tablet + Atazanavir (ATV) 300 mg capsule + Ritonavir (RTV) 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54047|NCT02246998|P1|Participant Flow|STB + Iohexol|Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (STB; Stribild®; EVG/COBI/FTC/TDF; 150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54048|NCT02246998|O4|Outcome|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54049|NCT02246998|O3|Outcome|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54050|NCT02246998|O2|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54051|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54052|NCT02246998|O4|Outcome|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54053|NCT02246998|O3|Outcome|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54386|NCT02246114|P1|Participant Flow|Arm A|no CO monitor
54054|NCT02246998|O2|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54055|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54056|NCT02246998|O4|Outcome|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54057|NCT02246998|O3|Outcome|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54058|NCT02246998|O2|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54059|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54060|NCT02246998|O4|Outcome|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54061|NCT02246998|O3|Outcome|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54062|NCT02246998|O2|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54063|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54064|NCT02246998|O4|Outcome|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54065|NCT02246998|O3|Outcome|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54066|NCT02246998|O2|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54067|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54068|NCT02246998|O3|Outcome|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54069|NCT02246998|O2|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54070|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54071|NCT02246998|O3|Outcome|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54072|NCT02246998|O2|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54073|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54074|NCT02246998|O3|Outcome|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54075|NCT02246998|O2|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54076|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54077|NCT02246998|O3|Outcome|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54078|NCT02246998|O2|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54079|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54080|NCT02246998|O3|Outcome|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54081|NCT02246998|O2|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54082|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54387|NCT02246114|O2|Outcome|Arm B|CO monitor
54084|NCT02246998|O2|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54085|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54086|NCT02246998|O3|Outcome|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54087|NCT02246998|O2|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54088|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54089|NCT02246998|O3|Outcome|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54090|NCT02246998|O2|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54091|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54092|NCT02246998|O2|Outcome|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54093|NCT02246998|O1|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54094|NCT02246998|O2|Outcome|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54095|NCT02246998|O1|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54096|NCT02246998|O2|Outcome|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54097|NCT02246998|O1|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54098|NCT02246998|O2|Outcome|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54099|NCT02246998|O1|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54100|NCT02246998|O2|Outcome|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54101|NCT02246998|O1|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54102|NCT02246998|O2|Outcome|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54103|NCT02246998|O1|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54104|NCT02246998|O2|Outcome|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54105|NCT02246998|O1|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54106|NCT02246998|O2|Outcome|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54107|NCT02246998|O1|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54108|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54109|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54110|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54111|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54112|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54113|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54114|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54115|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54116|NCT02246998|O4|Outcome|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54117|NCT02246998|O3|Outcome|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54118|NCT02246998|O2|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54119|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54120|NCT02246998|O4|Outcome|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54121|NCT02246998|O3|Outcome|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54122|NCT02246998|O2|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54123|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54124|NCT02246998|O4|Outcome|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54125|NCT02246998|O3|Outcome|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54126|NCT02246998|O2|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54127|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54128|NCT02246998|O4|Outcome|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54129|NCT02246998|O3|Outcome|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54130|NCT02246998|O2|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54131|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54132|NCT02246998|O4|Outcome|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54133|NCT02246998|O3|Outcome|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54134|NCT02246998|O2|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54135|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54136|NCT02246998|O4|Outcome|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54137|NCT02246998|O3|Outcome|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54138|NCT02246998|O2|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54139|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54140|NCT02246998|O4|Outcome|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54141|NCT02246998|O3|Outcome|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54142|NCT02246998|O2|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54143|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54144|NCT02246998|O4|Outcome|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54145|NCT02246998|O3|Outcome|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54146|NCT02246998|O2|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54147|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54148|NCT02246998|O4|Outcome|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54149|NCT02246998|O3|Outcome|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54150|NCT02246998|O2|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54151|NCT02246998|O1|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54152|NCT02246998|E4|Reported Event|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54153|NCT02246998|E3|Reported Event|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54154|NCT02246998|E2|Reported Event|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
54155|NCT02246998|E1|Reported Event|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
54156|NCT02246764|B4|Baseline|Total|Total of all reporting groups
54157|NCT02246764|B3|Baseline|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
54158|NCT02246764|B2|Baseline|AR-13324 Ophthalmic Solution 0.02% BID|1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
54159|NCT02246764|B1|Baseline|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) and 1 drop placebo in the morning (AM) in both eyes (OU)
54160|NCT02246764|P3|Participant Flow|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
54161|NCT02246764|P2|Participant Flow|AR-13324 Ophthalmic Solution 0.02% BID|1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
54162|NCT02246764|P1|Participant Flow|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
54163|NCT02246764|O3|Outcome|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop Timolol maleate twice daily (BID) in the morning and evening (PM) in both eyes (OU)
54164|NCT02246764|O2|Outcome|AR-13324 Ophthalmic Solution 0.02% BID|1 drop AR-13324 twice daily (BID) in the morning and evening (PM) in both eyes (OU)
54165|NCT02246764|O1|Outcome|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) and 1 drop placebo in the morning (AM) in both eyes (OU)
54166|NCT02246764|E3|Reported Event|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
54167|NCT02246764|E2|Reported Event|AR-13324 Ophthalmic Solution 0.02% BID|1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
54168|NCT02246764|E1|Reported Event|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
54169|NCT02246673|B6|Baseline|Total|Total of all reporting groups
54170|NCT02246673|B5|Baseline|Cohort 5|
54171|NCT02246673|B4|Baseline|Cohort 4|
54172|NCT02246673|B3|Baseline|Cohort 3|
54173|NCT02246673|B2|Baseline|Cohort 2|
54174|NCT02246673|B1|Baseline|Cohort 1|
54175|NCT02246673|P5|Participant Flow|Cohort 5|(RDEA3170 10 mg + Febuxostat 40 mg; RDEA3170 15 mg + Febuxostat 40 mg; RDEA3170 20 mg + Febuxostat 40 mg)
54176|NCT02246673|P4|Participant Flow|Cohort 4|(RDEA3170 2.5 mg + Febuxostat 40 mg; RDEA3170 2.5 mg + Febuxostat 80 mg)
54177|NCT02246673|P3|Participant Flow|Cohort 3|(RDEA3170 5 mg + Febuxostat 40 mg; RDEA3170 5 mg + Febuxostat 80 mg)
54178|NCT02246673|P2|Participant Flow|Cohort 2|(RDEA3170 15 mg + Febuxostat 40 mg; RDEA3170 15 mg + Febuxostat 80 mg)
54179|NCT02246673|P1|Participant Flow|Cohort 1|(RDEA3170 10 mg + Febuxostat 40 mg; RDEA3170 10 mg + Febuxostat 80 mg)
54180|NCT02246673|O11|Outcome|RDEA3170 20 mg + Febuxostat 40 mg|Overall (Cohort 5)
54181|NCT02246673|O10|Outcome|RDEA3170 2.5 mg + Febuxostat 80 mg|Overall (Cohort 4)
54182|NCT02246673|O9|Outcome|RDEA3170 2.5 mg + Febuxostat 40 mg|Overall (Cohort 4)
54183|NCT02246673|O8|Outcome|RDEA3170 5 mg + Febuxostat 80 mg|Overall (Cohort 3)
54184|NCT02246673|O7|Outcome|RDEA3170 5 mg + Febuxostat 40 mg|Overall (Cohort 3)
54185|NCT02246673|O6|Outcome|RDEA3170 15 mg + Febuxostat 80 mg|Overall (Cohort 2)
54186|NCT02246673|O5|Outcome|RDEA3170 15 mg + Febuxostat 40 mg|Overall (Cohorts 2 and 5)
54187|NCT02246673|O4|Outcome|RDEA3170 10 mg + Febuxostat 80 mg|Overall (Cohort 1)
54188|NCT02246673|O3|Outcome|RDEA3170 10 mg + Febuxostat 40 mg|Overall (Cohorts 1 and 5)
54189|NCT02246673|O2|Outcome|Febuxostat 80 mg|Overall (Cohorts 1 through 5)
54190|NCT02246673|O1|Outcome|Febuxostat 40 mg|Overall (Cohorts 1 through 5)
54191|NCT02246673|O9|Outcome|RDEA3170 20 mg + Febuxostat 40 mg|Overall (Cohort 5)
54192|NCT02246673|O8|Outcome|RDEA3170 2.5 mg + Febuxostat 80 mg|Overall (Cohort 4)
54193|NCT02246673|O7|Outcome|RDEA3170 2.5 mg + Febuxostat 40 mg|Overall (Cohort 4)
54194|NCT02246673|O6|Outcome|RDEA3170 5 mg + Febuxostat 80 mg|Overall (Cohort 3)
54195|NCT02246673|O5|Outcome|RDEA3170 5 mg + Febuxostat 40 mg|Overall (Cohort 3)
54196|NCT02246673|O4|Outcome|RDEA3170 15 mg + Febuxostat 80 mg|Overall (Cohort 2)
54197|NCT02246673|O3|Outcome|RDEA3170 15 mg + Febuxostat 40 mg|Overall (Cohorts 2 and 5)
54198|NCT02246673|O2|Outcome|RDEA3170 10 mg + Febuxostat 80 mg|Overall (Cohort 1)
54199|NCT02246673|O1|Outcome|RDEA3170 10 mg + Febuxostat 40 mg|Overall (Cohorts 1 and 5)
54200|NCT02246673|O9|Outcome|RDEA3170 20 mg + Febuxostat 40 mg|Overall (Cohort 5)
54201|NCT02246673|O8|Outcome|RDEA3170 2.5 mg + Febuxostat 80 mg|Overall (Cohort 4)
54202|NCT02246673|O7|Outcome|RDEA3170 2.5 mg + Febuxostat 40 mg|Overall (Cohort 4)
54203|NCT02246673|O6|Outcome|RDEA3170 5 mg + Febuxostat 80 mg|Overall (Cohort 3)
54204|NCT02246673|O5|Outcome|RDEA3170 5 mg + Febuxostat 40 mg|Overall (Cohort 3)
54205|NCT02246673|O4|Outcome|RDEA3170 15 mg + Febuxostat 80 mg|Overall (Cohort 2)
54206|NCT02246673|O3|Outcome|RDEA3170 15 mg + Febuxostat 40 mg|Overall (Cohorts 2 and 5)
54207|NCT02246673|O2|Outcome|RDEA3170 10 mg + Febuxostat 80 mg|Overall (Cohort 1)
54208|NCT02246673|O1|Outcome|RDEA3170 10 mg + Febuxostat 40 mg|Overall (Cohorts 1 and 5)
54209|NCT02246673|O9|Outcome|RDEA3170 20 mg + Febuxostat 40 mg|Overall (Cohort 5)
54210|NCT02246673|O8|Outcome|RDEA3170 2.5 mg + Febuxostat 80 mg|Overall (Cohort 4)
54211|NCT02246673|O7|Outcome|RDEA3170 2.5 mg + Febuxostat 40 mg|Overall (Cohort 4)
54212|NCT02246673|O6|Outcome|RDEA3170 5 mg + Febuxostat 80 mg|Overall (Cohort 3)
54213|NCT02246673|O5|Outcome|RDEA3170 5 mg + Febuxostat 40 mg|Overall (Cohort 3)
54214|NCT02246673|O4|Outcome|RDEA3170 15 mg + Febuxostat 80 mg|Overall (Cohort 2)
54215|NCT02246673|O3|Outcome|RDEA3170 15 mg + Febuxostat 40 mg|Overall (Cohorts 2 and 5)
54216|NCT02246673|O2|Outcome|RDEA3170 10 mg + Febuxostat 80 mg|Overall (Cohort 1)
54217|NCT02246673|O1|Outcome|RDEA3170 10 mg + Febuxostat 40 mg|Overall (Cohorts 1 and 5)
54218|NCT02246673|O9|Outcome|RDEA3170 20 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 5)
54219|NCT02246673|O8|Outcome|RDEA3170 2.5 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 4)
54220|NCT02246673|O7|Outcome|RDEA3170 2.5 mg + Febuxostat 40 mg|Overall (Cohort 4)
54221|NCT02246673|O6|Outcome|RDEA3170 5 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 3)
54222|NCT02246673|O5|Outcome|RDEA3170 5 mg + Febuxostat 40 mg|Overall (Cohort 3)
54223|NCT02246673|O4|Outcome|RDEA3170 15 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 2)
54224|NCT02246673|O3|Outcome|RDEA3170 15 mg + Febuxostat 40 mg|Overall (Cohorts 2 and 5)
54225|NCT02246673|O2|Outcome|RDEA3170 10 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 1)
54226|NCT02246673|O1|Outcome|RDEA3170 10 mg + Febuxostat 40 mg|Overall (Cohorts 1 and 5)
54227|NCT02246673|O9|Outcome|RDEA3170 20 mg + Febuxostat 40 mg|Overall (Cohort 5)
54228|NCT02246673|O8|Outcome|RDEA3170 2.5 mg + Febuxostat 80 mg|Overall (Cohort 4)
54229|NCT02246673|O7|Outcome|RDEA3170 2.5 mg + Febuxostat 40 mg|Overall (Cohort 4)
54230|NCT02246673|O6|Outcome|RDEA3170 5 mg + Febuxostat 80 mg|Overall (Cohort 3)
54231|NCT02246673|O5|Outcome|RDEA3170 5 mg + Febuxostat 40 mg|Overall (Cohort 3)
54232|NCT02246673|O4|Outcome|RDEA3170 15 mg + Febuxostat 80 mg|Overall (Cohort 2)
54233|NCT02246673|O3|Outcome|RDEA3170 15 mg + Febuxostat 40 mg|Overall (Cohorts 2 and 5)
54234|NCT02246673|O2|Outcome|RDEA3170 10 mg + Febuxostat 80 mg|Overall (Cohort 1)
54235|NCT02246673|O1|Outcome|RDEA3170 10 mg + Febuxostat 40 mg|Overall (Cohorts 1 and 5)
54236|NCT02246673|O11|Outcome|RDEA3170 20 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 5)
54237|NCT02246673|O10|Outcome|RDEA3170 2.5 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 4)
54238|NCT02246673|O9|Outcome|RDEA3170 2.5 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 4)
54239|NCT02246673|O8|Outcome|RDEA3170 5 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 3)
54240|NCT02246673|O7|Outcome|RDEA3170 5 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 3)
54241|NCT02246673|O6|Outcome|RDEA3170 15 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 2)
54242|NCT02246673|O5|Outcome|RDEA3170 15 mg + Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 2 and 5)
54243|NCT02246673|O4|Outcome|RDEA3170 10 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 1)
54244|NCT02246673|O3|Outcome|RDEA3170 10 mg + Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 1 and 5)
54245|NCT02246673|O2|Outcome|Febuxostat 80 mg|Days 14/21 Overall (Cohorts 1 through 5)
54246|NCT02246673|O1|Outcome|Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 1 through 5)
54247|NCT02246673|O11|Outcome|RDEA3170 20 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 5)
54248|NCT02246673|O10|Outcome|RDEA3170 2.5 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 4)
54249|NCT02246673|O9|Outcome|RDEA3170 2.5 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 4)
54250|NCT02246673|O8|Outcome|RDEA3170 5 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 3)
54251|NCT02246673|O7|Outcome|RDEA3170 5 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 3)
54252|NCT02246673|O6|Outcome|RDEA3170 15 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 2)
54253|NCT02246673|O5|Outcome|RDEA3170 15 mg + Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 2 and 5)
54254|NCT02246673|O4|Outcome|RDEA3170 10 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 1)
54255|NCT02246673|O3|Outcome|RDEA3170 10 mg + Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 1 and 5)
54256|NCT02246673|O2|Outcome|Febuxostat 80 mg|Days 14/21 Overall (Cohorts 1 through 5)
54257|NCT02246673|O1|Outcome|Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 1 through 5)
54258|NCT02246673|O11|Outcome|RDEA3170 20 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 5)
54259|NCT02246673|O10|Outcome|RDEA3170 2.5 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 4)
54260|NCT02246673|O9|Outcome|RDEA3170 2.5 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 4)
54261|NCT02246673|O8|Outcome|RDEA3170 5 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 3)
54262|NCT02246673|O7|Outcome|RDEA3170 5 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 3)
54263|NCT02246673|O6|Outcome|RDEA3170 15 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 2)
54264|NCT02246673|O5|Outcome|RDEA3170 15 mg + Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 2 and 5)
54265|NCT02246673|O4|Outcome|RDEA3170 10 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 1)
54266|NCT02246673|O3|Outcome|RDEA3170 10 mg + Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 1 and 5)
54267|NCT02246673|O2|Outcome|Febuxostat 80 mg|Days 14/21 Overall (Cohorts 1 through 5)
54268|NCT02246673|O1|Outcome|Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 1 through 5)
54269|NCT02246673|O11|Outcome|RDEA3170 20 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 5)
54270|NCT02246673|O10|Outcome|RDEA3170 2.5 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 4)
54271|NCT02246673|O9|Outcome|RDEA3170 2.5 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 4)
54272|NCT02246673|O8|Outcome|RDEA3170 5 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 3)
54273|NCT02246673|O7|Outcome|RDEA3170 5 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 3)
54274|NCT02246673|O6|Outcome|RDEA3170 15 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 2)
54275|NCT02246673|O5|Outcome|RDEA3170 15 mg + Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 2 and 5)
54276|NCT02246673|O4|Outcome|RDEA3170 10 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 1)
54277|NCT02246673|O3|Outcome|RDEA3170 10 mg + Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 1 and 5)
54278|NCT02246673|O2|Outcome|Febuxostat 80 mg|Days 7/28 Overall (Cohorts 1 through 5)
54279|NCT02246673|O1|Outcome|Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 1 through 5)
54280|NCT02246673|E3|Reported Event|Overall RDEA3170 + Febuxostat Combination|
54281|NCT02246673|E2|Reported Event|Febuxostat 80 mg|
54282|NCT02246673|E1|Reported Event|Febuxostat 40 mg|
54283|NCT02246660|B4|Baseline|Total|Total of all reporting groups
54284|NCT02246660|B3|Baseline|Placebo|"Placebo will be taken orally for 6 months.~Placebo: Placebo will be taken orally for 6 months."
54285|NCT02246660|B2|Baseline|Resveratrol - 125 mg/Day|"The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.~Resveratrol: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.~OR~The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative."
54286|NCT02246660|B1|Baseline|Resveratrol - 500 mg/Day|"The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.~Resveratrol: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.~OR~The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative."
54287|NCT02246660|P3|Participant Flow|Placebo|"Placebo will be taken orally for 6 months.~Placebo: Placebo will be taken orally for 6 months."
54288|NCT02246660|P2|Participant Flow|Resveratrol - 125 mg/Day|"The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.~Resveratrol: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.~OR~The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative."
54289|NCT02246660|P1|Participant Flow|Resveratrol - 500 mg/Day|"The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.~Resveratrol: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.~OR~The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative."
54290|NCT02246660|O3|Outcome|Placebo|"Placebo will be taken orally for 6 months.~Placebo: Placebo will be taken orally for 6 months."
54291|NCT02246660|O2|Outcome|Resveratrol - 125 mg/Day|"The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.~Resveratrol: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.~OR~The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative."
54292|NCT02246660|O1|Outcome|Resveratrol - 500 mg/Day|"The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.~Resveratrol: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.~OR~The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative."
54293|NCT02246660|E3|Reported Event|Placebo|Placebo will be taken orally for 6 months.
54294|NCT02246660|E2|Reported Event|Resveratrol - 125 mg/Day|The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
54295|NCT02246660|E1|Reported Event|Resveratrol - 500 mg/Day|The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
54296|NCT02246621|B3|Baseline|Total|Total of all reporting groups
54297|NCT02246621|B2|Baseline|Placebo + NSAI|Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54298|NCT02246621|B1|Baseline|Abemaciclib + NSAI|150 milligrams (mg) Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54299|NCT02246621|P2|Participant Flow|Placebo + NSAI|Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54300|NCT02246621|P1|Participant Flow|Abemaciclib + NSAI (Nonsteroidal Aromatase Inhibitors)|150 milligrams (mg) Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54301|NCT02246621|O1|Outcome|Abemaciclib + NSAI|150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54302|NCT02246621|O1|Outcome|Abemaciclib + NSAI|150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54303|NCT02246621|O2|Outcome|Placebo + NSAI|Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54304|NCT02246621|O1|Outcome|Abemaciclib + NSAI|150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54305|NCT02246621|O2|Outcome|Placebo + NSAI|Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54306|NCT02246621|O1|Outcome|Abemaciclib + NSAI|150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54307|NCT02246621|O2|Outcome|Placebo + NSAI|Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54308|NCT02246621|O1|Outcome|Abemaciclib + NSAI|150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54309|NCT02246621|O2|Outcome|Placebo + NSAI|Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54310|NCT02246621|O1|Outcome|Abemaciclib + NSAI|150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54311|NCT02246621|O2|Outcome|Placebo + NSAI|Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54312|NCT02246621|O1|Outcome|Abemaciclib + NSAI|150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54313|NCT02246621|O2|Outcome|Placebo + NSAI|Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54314|NCT02246621|O1|Outcome|Abemaciclib + NSAI|150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54315|NCT02246621|O2|Outcome|Placebo + NSAI|Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54316|NCT02246621|O1|Outcome|Abemaciclib + NSAI|150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54317|NCT02246621|O2|Outcome|Placebo + NSAI|Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54318|NCT02246621|O1|Outcome|Abemaciclib + NSAI|150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54319|NCT02246621|O2|Outcome|Placebo + NSAI|Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54320|NCT02246621|O1|Outcome|Abemaciclib + NSAI|150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54321|NCT02246621|O2|Outcome|Placebo + NSAI|Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54322|NCT02246621|O1|Outcome|Abemaciclib + NSAI|150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54323|NCT02246621|E2|Reported Event|Placebo + NSAI|Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54324|NCT02246621|E1|Reported Event|Abemaciclib + NSAI|150 milligrams (mg) Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
54325|NCT02246582|B1|Baseline|All Subjects|"Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.~Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.~Guardian Mobile App~640G Insulin Pump"
54326|NCT02246582|P2|Participant Flow|Group B (FST 14 Hrs After Sensor Insertion)|"Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.~Guardian Mobile App~640G Insulin Pump"
54327|NCT02246582|P1|Participant Flow|Group A (FST 30 Mins After Sensor Insertion)|"Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.~Guardian Mobile App~640G Insulin Pump"
54328|NCT02246582|O1|Outcome|Group|"Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.~Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.~Guardian Mobile App~640G Insulin Pump"
54388|NCT02246114|O1|Outcome|Arm A|no CO monitor
54389|NCT02246114|E2|Reported Event|Arm B (CO Monitor)|CO monitor
54390|NCT02246114|E1|Reported Event|Arm A (no CO Monitor)|no CO monitor
54329|NCT02246582|O1|Outcome|Group|"Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.~Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.~Guardian Mobile App~640G Insulin Pump"
54330|NCT02246582|O1|Outcome|Group|"Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.~Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.~Guardian Mobile App~640G Insulin Pump"
54331|NCT02246582|E1|Reported Event|Group|"Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.~Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.~Guardian Mobile App~640G Insulin Pump"
54332|NCT02246309|B3|Baseline|Total|Total of all reporting groups
54333|NCT02246309|B2|Baseline|Standard Embryo Culture|"All embryos from patients randomized to this arm will be cultured in the standard embryo culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.~Standard Embryo Culture: Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system."
54334|NCT02246309|B1|Baseline|Embryoscope Time Lapse System|"All embryos from patients randomized to this arm will be cultured in the Embryoscope culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.~Embryoscope Time Lapse System: The EmbryoScope® time-lapse system is a unique platform facilitating improved IVF treatment, flexible work routines and effective communication, through comprehensive documentation of embryo development and evolving improvements in selection."
54335|NCT02246309|P2|Participant Flow|Standard Embryo Culture|"All embryos from patients randomized to this arm will be cultured in the standard embryo culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.~Standard Embryo Culture: Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system."
54336|NCT02246309|P1|Participant Flow|Embryoscope Time Lapse System|"All embryos from patients randomized to this arm will be cultured in the Embryoscope culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.~Embryoscope Time Lapse System: The EmbryoScope® time-lapse system is a unique platform facilitating improved IVF treatment, flexible work routines and effective communication, through comprehensive documentation of embryo development and evolving improvements in selection."
54337|NCT02246309|O2|Outcome|Standard Embryo Culture|"All embryos from patients randomized to this arm will be cultured in the standard embryo culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.~Standard Embryo Culture: Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system."
54338|NCT02246309|O1|Outcome|Embryoscope Time Lapse System|"All embryos from patients randomized to this arm will be cultured in the Embryoscope culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.~Embryoscope Time Lapse System: The EmbryoScope® time-lapse system is a unique platform facilitating improved IVF treatment, flexible work routines and effective communication, through comprehensive documentation of embryo development and evolving improvements in selection."
54339|NCT02246309|O2|Outcome|Standard Embryo Culture|"All embryos from patients randomized to this arm will be cultured in the standard embryo culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.~Standard Embryo Culture: Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system."
54340|NCT02246309|O1|Outcome|Embryoscope Time Lapse System|"All embryos from patients randomized to this arm will be cultured in the Embryoscope culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.~Embryoscope Time Lapse System: The EmbryoScope® time-lapse system is a unique platform facilitating improved IVF treatment, flexible work routines and effective communication, through comprehensive documentation of embryo development and evolving improvements in selection."
54341|NCT02246309|O2|Outcome|Standard Embryo Culture|"All embryos from patients randomized to this arm will be cultured in the standard embryo culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.~Standard Embryo Culture: Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system."
54342|NCT02246309|O1|Outcome|Embryoscope Time Lapse System|"All embryos from patients randomized to this arm will be cultured in the Embryoscope culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.~Embryoscope Time Lapse System: The EmbryoScope® time-lapse system is a unique platform facilitating improved IVF treatment, flexible work routines and effective communication, through comprehensive documentation of embryo development and evolving improvements in selection."
54343|NCT02246309|E2|Reported Event|Standard Embryo Culture|"All embryos from patients randomized to this arm will be cultured in the standard embryo culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.~Standard Embryo Culture: Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system."
54391|NCT02246062|B5|Baseline|Total|Total of all reporting groups
54546|NCT02243293|P1|Participant Flow|Arm A|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.
54344|NCT02246309|E1|Reported Event|Embryoscope Time Lapse System|"All embryos from patients randomized to this arm will be cultured in the Embryoscope culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.~Embryoscope Time Lapse System: The EmbryoScope® time-lapse system is a unique platform facilitating improved IVF treatment, flexible work routines and effective communication, through comprehensive documentation of embryo development and evolving improvements in selection."
54345|NCT02246166|B3|Baseline|Total|Total of all reporting groups
54346|NCT02246166|B2|Baseline|Placebo|Matching placebo tablet
54347|NCT02246166|B1|Baseline|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
54348|NCT02246166|P2|Participant Flow|Placebo|Matching placebo tablet
54349|NCT02246166|P1|Participant Flow|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
54350|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
54351|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
54352|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
54353|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
54354|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
54355|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
54356|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
54357|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
54358|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
54359|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
54360|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
54361|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
54362|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
54363|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
54364|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
54365|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
54366|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
54367|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
54368|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
54369|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
54370|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
54371|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
54372|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
54373|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
54374|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
54375|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
54376|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
54377|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
54378|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
54379|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
54380|NCT02246166|E2|Reported Event|Placebo|Matching placebo tablet
54381|NCT02246166|E1|Reported Event|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
54382|NCT02246114|B3|Baseline|Total|Total of all reporting groups
54383|NCT02246114|B2|Baseline|Arm B|CO monitor
54384|NCT02246114|B1|Baseline|Arm A|no CO monitor
54385|NCT02246114|P2|Participant Flow|Arm B|CO monitor
54392|NCT02246062|B4|Baseline|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.~smartphone: the child received smartphone application immediately before entering the operating room"
54393|NCT02246062|B3|Baseline|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room~smartphone: the child received smartphone application immediately before entering the operating room"
54394|NCT02246062|B2|Baseline|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
54395|NCT02246062|B1|Baseline|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
54396|NCT02246062|P4|Participant Flow|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.~smartphone: the child received smartphone application immediately before entering the operating room"
54397|NCT02246062|P3|Participant Flow|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room~smartphone: the child received smartphone application immediately before entering the operating room"
54398|NCT02246062|P2|Participant Flow|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
54399|NCT02246062|P1|Participant Flow|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
54400|NCT02246062|O4|Outcome|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.~smartphone: the child received smartphone application immediately before entering the operating room"
54401|NCT02246062|O3|Outcome|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room~smartphone: the child received smartphone application immediately before entering the operating room"
54402|NCT02246062|O2|Outcome|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
54403|NCT02246062|O1|Outcome|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
54404|NCT02246062|O4|Outcome|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.~smartphone: the child received smartphone application immediately before entering the operating room"
54405|NCT02246062|O3|Outcome|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room~smartphone: the child received smartphone application immediately before entering the operating room"
54406|NCT02246062|O2|Outcome|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
54407|NCT02246062|O1|Outcome|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
54408|NCT02246062|O4|Outcome|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.~smartphone: the child received smartphone application immediately before entering the operating room"
54409|NCT02246062|O3|Outcome|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room~smartphone: the child received smartphone application immediately before entering the operating room"
54410|NCT02246062|O2|Outcome|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
54411|NCT02246062|O1|Outcome|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
54457|NCT02244944|O1|Outcome|EZ-URSO Combination Therapy|"Ursodiol (URSO Forte) 13-15 mg per kg (250-500 mg b.i.d. or t.i.d depending on body weight) combined with Ezetimibe (Zetia) 10 mg o.p.d.~EZ-Urso combination therapy: Ursodiol 13-15 mg per kg per day combined with Ezetimibe (Zetia) 10 mg per day"
54547|NCT02243293|O17|Outcome|Arm S2|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.
54412|NCT02246062|E4|Reported Event|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.~smartphone: the child received smartphone application immediately before entering the operating room"
54413|NCT02246062|E3|Reported Event|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room~smartphone: the child received smartphone application immediately before entering the operating room"
54414|NCT02246062|E2|Reported Event|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
54415|NCT02246062|E1|Reported Event|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
54416|NCT02245412|B4|Baseline|Total|Total of all reporting groups
54417|NCT02245412|B3|Baseline|ALXN1007 20mg/kg Twice a Week|16 IV doses of 20 mg/kg of ALXN1007 twice weekly
54418|NCT02245412|B2|Baseline|ALXN1007 20mg/kg Once a Week|8 IV doses of 20 mg/kg of ALXN1007 once weekly
54419|NCT02245412|B1|Baseline|ALXN1007 10mg/kg Once a Week|8 IV doses of 10 mg/kg of ALXN1007 once weekly
54420|NCT02245412|P3|Participant Flow|ALXN1007 20mg/kg Twice a Week|ALXN1007: 16 IV doses of 20 mg/kg of ALXN1007 twice weekly
54421|NCT02245412|P2|Participant Flow|ALXN1007 20mg/kg Once a Week|ALXN1007: 8 IV doses of 20 mg/kg of ALXN1007 once weekly
54422|NCT02245412|P1|Participant Flow|ALXN1007 10mg/kg Once a Week|ALXN1007: 8 IV doses of 10 mg/kg of ALXN1007 once weekly
54423|NCT02245412|O3|Outcome|ALXN1007 20mg/kg Twice a Week|16 IV doses of 20 mg/kg of ALXN1007 twice weekly
54424|NCT02245412|O2|Outcome|ALXN1007 20mg/kg Once a Week|8 IV doses of 20 mg/kg of ALXN1007 once weekly
54425|NCT02245412|O1|Outcome|ALXN1007 10mg/kg Once a Week|8 IV doses of 10 mg/kg of ALXN1007 once weekly
54426|NCT02245412|O3|Outcome|ALXN1007 20mg/kg Twice a Week|16 IV doses of 20 mg/kg of ALXN1007 twice weekly
54427|NCT02245412|O2|Outcome|ALXN1007 20mg/kg Once a Week|8 IV doses of 20 mg/kg of ALXN1007 once weekly
54428|NCT02245412|O1|Outcome|ALXN1007 10mg/kg Once a Week|8 IV doses of 10 mg/kg of ALXN1007 once weekly
54429|NCT02245412|O3|Outcome|ALXN1007 20mg/kg Twice a Week|16 IV doses of 20 mg/kg of ALXN1007 twice weekly
54430|NCT02245412|O2|Outcome|ALXN1007 20mg/kg Once a Week|8 IV doses of 20 mg/kg of ALXN1007 once weekly
54431|NCT02245412|O1|Outcome|ALXN1007 10mg/kg Once a Week|8 IV doses of 10 mg/kg of ALXN1007 once weekly
54432|NCT02245412|O3|Outcome|ALXN1007 20mg/kg Twice a Week|16 IV doses of 20 mg/kg of ALXN1007 twice weekly
54433|NCT02245412|O2|Outcome|ALXN1007 20mg/kg Once a Week|8 IV doses of 20 mg/kg of ALXN1007 once weekly
54434|NCT02245412|O1|Outcome|ALXN1007 10mg/kg Once a Week|8 IV doses of 10 mg/kg of ALXN1007 once weekly
54435|NCT02245412|E3|Reported Event|ALXN1007 20mg/kg Twice a Week|16 IV doses of 20 mg/kg of ALXN1007 twice weekly
54436|NCT02245412|E2|Reported Event|ALXN1007 20mg/kg Once a Week|8 IV doses of 20 mg/kg of ALXN1007 once weekly
54437|NCT02245412|E1|Reported Event|ALXN1007 10mg/kg Once a Week|8 IV doses of 10 mg/kg of ALXN1007 once weekly
54438|NCT02245360|B3|Baseline|Total|Total of all reporting groups
54439|NCT02245360|B2|Baseline|Placebo|"Placebo~placebo: placebo tablet given once daily over 60 days"
54440|NCT02245360|B1|Baseline|Grass Tablet 75,000 SQ-T|"Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)~Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days"
54441|NCT02245360|P2|Participant Flow|Placebo|"Placebo~placebo: placebo tablet given once daily over 60 days"
54442|NCT02245360|P1|Participant Flow|Grass Tablet 75,000 SQ-T|"Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)~Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days"
54443|NCT02245360|O2|Outcome|Placebo|"Placebo~placebo: placebo tablet given once daily over 60 days"
54444|NCT02245360|O1|Outcome|Grass Tablet 75,000 SQ-T|"Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)~Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days"
54445|NCT02245360|O2|Outcome|Placebo|"Placebo~placebo: placebo tablet given once daily over 60 days"
54446|NCT02245360|O1|Outcome|Grass Tablet 75,000 SQ-T|"Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)~Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days"
54447|NCT02245360|E2|Reported Event|Placebo|"Placebo~placebo: placebo tablet given once daily over 60 days"
54448|NCT02245360|E1|Reported Event|Grass Tablet 75,000 SQ-T|"Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)~Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days"
54449|NCT02245217|B1|Baseline|PET/CT Imaging Arm|PET/CT scan to assess treatment efficacy
54450|NCT02245217|P1|Participant Flow|PET/CT Imaging Arm|PET/CT scan to assess treatment efficacy
54451|NCT02245217|O1|Outcome|PET/CT Imaging Arm|PET/CT scan to assess treatment efficacy
54452|NCT02245217|O1|Outcome|PET/CT Imaging Arm|PET/CT scan to assess treatment efficacy
54453|NCT02245217|O1|Outcome|PET/CT Imaging Arm|PET/CT scan to assess treatment efficacy
54454|NCT02245217|E1|Reported Event|PET/CT Imaging Arm|PET/CT scan to assess treatment efficacy
54455|NCT02244944|B1|Baseline|EZ-URSO Combination Therapy|"Ursodiol (URSO Forte) 13-15 mg per kg (250-500 mg b.i.d. or t.i.d depending on body weight) combined with Ezetimibe (Zetia) 10 mg o.p.d.~EZ-Urso combination therapy: Ursodiol 13-15 mg per kg per day combined with Ezetimibe (Zetia) 10 mg per day"
54456|NCT02244944|P1|Participant Flow|EZ-URSO Combination Therapy|"Ursodiol (URSO Forte) 13-15 mg per kg (250-500 mg b.i.d. or t.i.d depending on body weight) combined with Ezetimibe (Zetia) 10 mg o.p.d.~EZ-Urso combination therapy: Ursodiol 13-15 mg per kg per day combined with Ezetimibe (Zetia) 10 mg per day"
87169|NCT02040792|P2|Participant Flow|44 mcg|"TD-4208~TD-4208"
54458|NCT02244944|O1|Outcome|EZ-URSO Combination Therapy|"Ursodiol (URSO Forte) 13-15 mg per kg (250-500 mg b.i.d. or t.i.d depending on body weight) combined with Ezetimibe (Zetia) 10 mg o.p.d.~EZ-Urso combination therapy: Ursodiol 13-15 mg per kg per day combined with Ezetimibe (Zetia) 10 mg per day"
54459|NCT02244944|O1|Outcome|EZ-URSO Combination Therapy|"Ursodiol (URSO Forte) 13-15 mg per kg (250-500 mg b.i.d. or t.i.d depending on body weight) combined with Ezetimibe (Zetia) 10 mg o.p.d.~EZ-Urso combination therapy: Ursodiol 13-15 mg per kg per day combined with Ezetimibe (Zetia) 10 mg per day"
54460|NCT02244944|E1|Reported Event|EZ-URSO Combination Therapy|"Ursodiol (URSO Forte) 13-15 mg per kg (250-500 mg b.i.d. or t.i.d depending on body weight) combined with Ezetimibe (Zetia) 10 mg o.p.d.~EZ-Urso combination therapy: Ursodiol 13-15 mg per kg per day combined with Ezetimibe (Zetia) 10 mg per day"
54461|NCT02244840|B1|Baseline|Electronic Bidet and Sitz Bath|"Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject~Electronic bidet: commercial electronic bidet~Sitz bath: Conventional sitz bath"
54462|NCT02244840|P1|Participant Flow|Electronic Bidet and Sitz Bath|"Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject~Electronic bidet: commercial electronic bidet~Sitz bath: Conventional sitz bath"
54463|NCT02244840|O1|Outcome|Electronic Bidet and Sitz Bath|"Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject~Electronic bidet: commercial electronic bidet~Sitz bath: Conventional sitz bath"
54464|NCT02244840|E1|Reported Event|Electronic Bidet and Sitz Bath|"Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject~Electronic bidet: commercial electronic bidet~Sitz bath: Conventional sitz bath"
54465|NCT02244619|B3|Baseline|Total|Total of all reporting groups
54466|NCT02244619|B2|Baseline|IV Acetaminophen|"Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.~IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity."
54467|NCT02244619|B1|Baseline|Oral Acetaminophen|"Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.~Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity."
54468|NCT02244619|P2|Participant Flow|IV Acetaminophen|"Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.~IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity."
54469|NCT02244619|P1|Participant Flow|Oral Acetaminophen|"Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.~Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity."
54470|NCT02244619|O2|Outcome|IV Acetaminophen|"Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.~IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity."
54471|NCT02244619|O1|Outcome|Oral Acetaminophen|"Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.~Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity."
54472|NCT02244619|O2|Outcome|IV Acetaminophen|"Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.~IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity."
54545|NCT02243293|P2|Participant Flow|Arm B|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
54473|NCT02244619|O1|Outcome|Oral Acetaminophen|"Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.~Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity."
54474|NCT02244619|O2|Outcome|IV Acetaminophen|"Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.~IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity."
54475|NCT02244619|O1|Outcome|Oral Acetaminophen|"Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.~Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity."
54476|NCT02244619|O2|Outcome|IV Acetaminophen|"Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.~IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity."
54477|NCT02244619|O1|Outcome|Oral Acetaminophen|"Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.~Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity."
54478|NCT02244619|O2|Outcome|IV Acetaminophen|"Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.~IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity."
54479|NCT02244619|O1|Outcome|Oral Acetaminophen|"Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.~Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity."
54480|NCT02244619|O2|Outcome|IV Acetaminophen|"Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.~IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity."
54481|NCT02244619|O1|Outcome|Oral Acetaminophen|"Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.~Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity."
54482|NCT02244619|O2|Outcome|IV Acetaminophen|"Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.~IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity."
54483|NCT02244619|O1|Outcome|Oral Acetaminophen|"Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.~Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity."
54484|NCT02244619|E2|Reported Event|IV Acetaminophen|"Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.~IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity."
54485|NCT02244619|E1|Reported Event|Oral Acetaminophen|"Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.~Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity."
54486|NCT02244580|B1|Baseline|FinHer Patients|"Of all patients, FFPE tumour block was processed with the RNXtract RNA extraction kit (BioNTech Diagnostics GmbH, Mainz) using a magnetic particle-based assay (Supplemental file 1A).~RT-qPCR was done with the MammaTyper kit (BioNTech Diagnostics GmbH, Mainz) for ESR1, PGR, ERBB2 and MKI67."
54487|NCT02244580|P1|Participant Flow|MammaTyper™|"MammaTyper™ kit will be used to assess tumor material of patients enrolled into the FinHer trial.~MammaTyper™: MammaTyper™ kit is a molecular in vitro diagnostic test for the quantitative detection of the ribonuclease acid (RNA) expression status of the genes for estrogen receptor (ESR1), progesterone receptor (PGR), human epidermal growth factor receptor 2 (HER2) and proliferation antigen KI 67."
54488|NCT02244580|O2|Outcome|OS According to MKI67 mRNA and Ki-67 Protein (IHC) Levels|Determination of OS of patients according to MKI67 mRNA (RT-qPCR) and Ki-67 protein (IHC) levels
54489|NCT02244580|O1|Outcome|DDFS According to MKI67 mRNA and Ki-67 Protein (IHC) Levels|Determination of DDFS of patients according to MKI67 mRNA (RT-qPCR) and Ki-67 protein (IHC) levels
54490|NCT02244580|O1|Outcome|Patients With MKI67 mRNA Determination|Patients with low MKI67 mRNA
54491|NCT02244580|O2|Outcome|Combined Subtype|Patients subtyped as Luminal B, HER2 positive, triple negative with DDFS determined 5 years after randomisation
54492|NCT02244580|O1|Outcome|Luminal A|Patients subtyped as Luminal A with DDFS determined 5 years after randomisation
54493|NCT02244580|E1|Reported Event||Since only tumor material was used, adverse events were not documented within the MammaTyper Study
54494|NCT02243943|B3|Baseline|Total|Total of all reporting groups
54495|NCT02243943|B2|Baseline|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg~Neostigmine"
54496|NCT02243943|B1|Baseline|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg~Sugammadex"
54497|NCT02243943|P2|Participant Flow|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg~Neostigmine"
54498|NCT02243943|P1|Participant Flow|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg~Sugammadex"
54499|NCT02243943|O2|Outcome|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg~Neostigmine"
54500|NCT02243943|O1|Outcome|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg~Sugammadex"
54501|NCT02243943|O2|Outcome|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg~Neostigmine"
54502|NCT02243943|O1|Outcome|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg~Sugammadex"
54503|NCT02243943|O2|Outcome|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg~Neostigmine"
54504|NCT02243943|O1|Outcome|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg~Sugammadex"
54505|NCT02243943|E2|Reported Event|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg~Neostigmine"
54506|NCT02243943|E1|Reported Event|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg~Sugammadex"
54507|NCT02243293|B18|Baseline|Total|Total of all reporting groups
54508|NCT02243293|B17|Baseline|Arm S2|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.
54509|NCT02243293|B16|Baseline|Arm S1|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.
54510|NCT02243293|B15|Baseline|Arm R2|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.
54511|NCT02243293|B14|Baseline|Arm R1|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
54512|NCT02243293|B13|Baseline|Arm Q2|ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
54513|NCT02243293|B12|Baseline|Arm Q1|ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.
54514|NCT02243293|B11|Baseline|Arm P|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.
56309|NCT02230670|P1|Participant Flow|IDN-6556|"25 mg BID of IDN-6556~IDN-6556: 25 mg BID"
54515|NCT02243293|B10|Baseline|Arm O|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.
54516|NCT02243293|B9|Baseline|Arm L|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
54517|NCT02243293|B8|Baseline|Arm J|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
54518|NCT02243293|B7|Baseline|Arm G|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
54519|NCT02243293|B6|Baseline|Arm F|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
54520|NCT02243293|B5|Baseline|Arm E|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
54521|NCT02243293|B4|Baseline|Arm D|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.
54522|NCT02243293|B3|Baseline|Arm C|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
54523|NCT02243293|B2|Baseline|Arm B|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
54524|NCT02243293|B1|Baseline|Arm A|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.
54525|NCT02243293|P22|Participant Flow|Arm S2|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.
54526|NCT02243293|P21|Participant Flow|Arm S1|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.
54527|NCT02243293|P20|Participant Flow|Arm R2|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.
54528|NCT02243293|P19|Participant Flow|Arm R1|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
54529|NCT02243293|P18|Participant Flow|Arm Q2|ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
54530|NCT02243293|P17|Participant Flow|Arm Q1|ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.
54531|NCT02243293|P16|Participant Flow|Arm P|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.
54532|NCT02243293|P15|Participant Flow|Arm O|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.
54533|NCT02243293|P14|Participant Flow|Arm N|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD and ribavirin (RBV) (800 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis.
54534|NCT02243293|P13|Participant Flow|Arm M|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis.
54535|NCT02243293|P12|Participant Flow|Arm L|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
54536|NCT02243293|P11|Participant Flow|Arm K|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
54537|NCT02243293|P10|Participant Flow|Arm J|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
54538|NCT02243293|P9|Participant Flow|Arm I|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
54539|NCT02243293|P8|Participant Flow|Arm H|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
54540|NCT02243293|P7|Participant Flow|Arm G|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
54541|NCT02243293|P6|Participant Flow|Arm F|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
54542|NCT02243293|P5|Participant Flow|Arm E|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
54543|NCT02243293|P4|Participant Flow|Arm D|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.
54544|NCT02243293|P3|Participant Flow|Arm C|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
54724|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
54548|NCT02243293|O16|Outcome|Arm S1|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.
54549|NCT02243293|O15|Outcome|Arm R2|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.
54550|NCT02243293|O14|Outcome|Arm R1|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
54551|NCT02243293|O13|Outcome|Arm Q2|ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
54552|NCT02243293|O12|Outcome|Arm Q1|ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.
54553|NCT02243293|O11|Outcome|Arm P|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.
54554|NCT02243293|O10|Outcome|Arm O|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.
54555|NCT02243293|O9|Outcome|Arm L|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
54556|NCT02243293|O8|Outcome|Arm J|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
54557|NCT02243293|O7|Outcome|Arm G|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
54558|NCT02243293|O6|Outcome|Arm F|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
54559|NCT02243293|O5|Outcome|Arm E|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
54560|NCT02243293|O4|Outcome|Arm D|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.
54561|NCT02243293|O3|Outcome|Arm C|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
54562|NCT02243293|O2|Outcome|Arm B|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
54563|NCT02243293|O1|Outcome|Arm A|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.
54564|NCT02243293|O17|Outcome|Arm S2|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.
54565|NCT02243293|O16|Outcome|Arm S1|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.
54566|NCT02243293|O15|Outcome|Arm R2|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.
54567|NCT02243293|O14|Outcome|Arm R1|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
54568|NCT02243293|O13|Outcome|Arm Q2|ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
54569|NCT02243293|O12|Outcome|Arm Q1|ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.
54570|NCT02243293|O11|Outcome|Arm P|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.
54571|NCT02243293|O10|Outcome|Arm O|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.
54572|NCT02243293|O9|Outcome|Arm L|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
54573|NCT02243293|O8|Outcome|Arm J|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
54574|NCT02243293|O7|Outcome|Arm G|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
54575|NCT02243293|O6|Outcome|Arm F|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
54576|NCT02243293|O5|Outcome|Arm E|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
54577|NCT02243293|O4|Outcome|Arm D|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.
54578|NCT02243293|O3|Outcome|Arm C|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
54579|NCT02243293|O2|Outcome|Arm B|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
54580|NCT02243293|O1|Outcome|Arm A|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.
54581|NCT02243293|O17|Outcome|Arm S2|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.
54582|NCT02243293|O16|Outcome|Arm S1|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.
54583|NCT02243293|O15|Outcome|Arm R2|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.
54584|NCT02243293|O14|Outcome|Arm R1|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
54585|NCT02243293|O13|Outcome|Arm Q2|ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
54586|NCT02243293|O12|Outcome|Arm Q1|ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.
54587|NCT02243293|O11|Outcome|Arm P|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.
54588|NCT02243293|O10|Outcome|Arm O|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.
54589|NCT02243293|O9|Outcome|Arm L|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
54590|NCT02243293|O8|Outcome|Arm J|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
54591|NCT02243293|O7|Outcome|Arm G|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
54592|NCT02243293|O6|Outcome|Arm F|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
54593|NCT02243293|O5|Outcome|Arm E|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
54594|NCT02243293|O4|Outcome|Arm D|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.
54595|NCT02243293|O3|Outcome|Arm C|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
54596|NCT02243293|O2|Outcome|Arm B|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
54597|NCT02243293|O1|Outcome|Arm A|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.
54598|NCT02243293|O1|Outcome|Arm S1|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.
54599|NCT02243293|O17|Outcome|Arm S2|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.
54600|NCT02243293|O16|Outcome|Arm S1|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.
54601|NCT02243293|O15|Outcome|Arm R2|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.
54602|NCT02243293|O14|Outcome|Arm R1|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
54603|NCT02243293|O13|Outcome|Arm Q2|ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
54604|NCT02243293|O12|Outcome|Arm Q1|ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.
54605|NCT02243293|O11|Outcome|Arm P|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.
54606|NCT02243293|O10|Outcome|Arm O|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.
54607|NCT02243293|O9|Outcome|Arm L|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
54608|NCT02243293|O8|Outcome|Arm J|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
54609|NCT02243293|O7|Outcome|Arm G|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
54610|NCT02243293|O6|Outcome|Arm F|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
54611|NCT02243293|O5|Outcome|Arm E|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
54645|NCT02243280|P11|Participant Flow|Arm K|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
54612|NCT02243293|O4|Outcome|Arm D|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.
54613|NCT02243293|O3|Outcome|Arm C|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
54614|NCT02243293|O2|Outcome|Arm B|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
54615|NCT02243293|O1|Outcome|Arm A|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.
54616|NCT02243293|E17|Reported Event|ARM S2|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.
54617|NCT02243293|E16|Reported Event|ARM S1|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.
54618|NCT02243293|E15|Reported Event|ARM R2|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.
54619|NCT02243293|E14|Reported Event|ARM R1|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
54620|NCT02243293|E13|Reported Event|ARM Q2|ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
54621|NCT02243293|E12|Reported Event|ARM Q1|ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.
54622|NCT02243293|E11|Reported Event|ARM P|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.
54623|NCT02243293|E10|Reported Event|ARM O|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.
54624|NCT02243293|E9|Reported Event|ARM L|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
54625|NCT02243293|E8|Reported Event|ARM J|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
54626|NCT02243293|E7|Reported Event|ARM G|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
54627|NCT02243293|E6|Reported Event|ARM F|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
54628|NCT02243293|E5|Reported Event|ARM E|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
54629|NCT02243293|E4|Reported Event|ARM D|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.
54630|NCT02243293|E3|Reported Event|ARM C|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
54631|NCT02243293|E2|Reported Event|ARM B|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
54632|NCT02243293|E1|Reported Event|ARM A|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.
54633|NCT02243280|B12|Baseline|Total|Total of all reporting groups
54634|NCT02243280|B11|Baseline|Arm K|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
54635|NCT02243280|B10|Baseline|Arm J|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened – Sponsor decision)
54636|NCT02243280|B9|Baseline|Arm I|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
54637|NCT02243280|B8|Baseline|Arm H|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
54638|NCT02243280|B7|Baseline|Arm G|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
54639|NCT02243280|B6|Baseline|Arm F|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
54640|NCT02243280|B5|Baseline|Arm E|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
54641|NCT02243280|B4|Baseline|Arm D|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
54642|NCT02243280|B3|Baseline|Arm C|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
54643|NCT02243280|B2|Baseline|Arm B|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis
54644|NCT02243280|B1|Baseline|Arm A|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
54725|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
54646|NCT02243280|P10|Participant Flow|Arm J|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened – Sponsor decision)
54647|NCT02243280|P9|Participant Flow|Arm I|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
54648|NCT02243280|P8|Participant Flow|Arm H|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
54649|NCT02243280|P7|Participant Flow|Arm G|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
54650|NCT02243280|P6|Participant Flow|Arm F|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
54651|NCT02243280|P5|Participant Flow|Arm E|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
54652|NCT02243280|P4|Participant Flow|Arm D|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
54653|NCT02243280|P3|Participant Flow|Arm C|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
54654|NCT02243280|P2|Participant Flow|Arm B|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis
54655|NCT02243280|P1|Participant Flow|Arm A|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
54656|NCT02243280|O11|Outcome|Arm K|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
54657|NCT02243280|O10|Outcome|Arm J|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened – Sponsor decision)
54658|NCT02243280|O9|Outcome|Arm I|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
54659|NCT02243280|O8|Outcome|Arm H|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
54660|NCT02243280|O7|Outcome|Arm G|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
54661|NCT02243280|O6|Outcome|Arm F|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
54662|NCT02243280|O5|Outcome|Arm E|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
54663|NCT02243280|O4|Outcome|Arm D|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
54664|NCT02243280|O3|Outcome|Arm C|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
54665|NCT02243280|O2|Outcome|Arm B|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis
54666|NCT02243280|O1|Outcome|Arm A|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
54667|NCT02243280|O11|Outcome|Arm K|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
54668|NCT02243280|O10|Outcome|Arm J|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened – Sponsor decision)
54669|NCT02243280|O9|Outcome|Arm I|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
54670|NCT02243280|O8|Outcome|Arm H|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
54671|NCT02243280|O7|Outcome|Arm G|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
54672|NCT02243280|O6|Outcome|Arm F|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
54673|NCT02243280|O5|Outcome|Arm E|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
54674|NCT02243280|O4|Outcome|Arm D|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
54675|NCT02243280|O3|Outcome|Arm C|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
54676|NCT02243280|O2|Outcome|Arm B|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis
54677|NCT02243280|O1|Outcome|Arm A|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
54678|NCT02243280|O11|Outcome|Arm K|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
54679|NCT02243280|O10|Outcome|Arm J|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened – Sponsor decision)
54680|NCT02243280|O9|Outcome|Arm I|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
54681|NCT02243280|O8|Outcome|Arm H|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
56310|NCT02230670|O2|Outcome|Placebo|"Placebo BID~Placebo"
54682|NCT02243280|O7|Outcome|Arm G|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
54683|NCT02243280|O6|Outcome|Arm F|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
54684|NCT02243280|O5|Outcome|Arm E|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
54685|NCT02243280|O4|Outcome|Arm D|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
54686|NCT02243280|O3|Outcome|Arm C|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
54687|NCT02243280|O2|Outcome|Arm B|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis
54688|NCT02243280|O1|Outcome|Arm A|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
54689|NCT02243280|O11|Outcome|Arm K|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
54690|NCT02243280|O10|Outcome|Arm J|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened – Sponsor decision)
54691|NCT02243280|O9|Outcome|Arm I|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
54692|NCT02243280|O8|Outcome|Arm H|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
54693|NCT02243280|O7|Outcome|Arm G|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
54694|NCT02243280|O6|Outcome|Arm F|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
54695|NCT02243280|O5|Outcome|Arm E|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
54696|NCT02243280|O4|Outcome|Arm D|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
54697|NCT02243280|O3|Outcome|Arm C|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
54698|NCT02243280|O2|Outcome|Arm B|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis
54699|NCT02243280|O1|Outcome|Arm A|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
54700|NCT02243280|E5|Reported Event|Arm K|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis
54701|NCT02243280|E4|Reported Event|Arm I|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6- infected participants without cirrhosis
54702|NCT02243280|E3|Reported Event|Arm F|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis
54703|NCT02243280|E2|Reported Event|Arm B|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
54704|NCT02243280|E1|Reported Event|Arm A|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
54705|NCT02243202|B5|Baseline|Total|Total of all reporting groups
54706|NCT02243202|B4|Baseline|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
54707|NCT02243202|B3|Baseline|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
54708|NCT02243202|B2|Baseline|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
54709|NCT02243202|B1|Baseline|Placebo|Participants received placebo tablets orally for 26 weeks.
54710|NCT02243202|P4|Participant Flow|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
54711|NCT02243202|P3|Participant Flow|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
54712|NCT02243202|P2|Participant Flow|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
54713|NCT02243202|P1|Participant Flow|Placebo|Participants received placebo tablets orally for 26 weeks.
54714|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
54715|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
54716|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
54717|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
54718|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
54719|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
54720|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
54721|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
54722|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
54723|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
54726|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
54727|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
54728|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
54729|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
54730|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
54731|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
54732|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
54733|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
54734|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
54735|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
54736|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
54737|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
54738|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
54739|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
54740|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
54741|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
54742|NCT02243202|E4|Reported Event|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
54743|NCT02243202|E3|Reported Event|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
54744|NCT02243202|E2|Reported Event|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
54745|NCT02243202|E1|Reported Event|Placebo|Participants received placebo tablets orally for 26 weeks.
54746|NCT02243176|B3|Baseline|Total|Total of all reporting groups
54747|NCT02243176|B2|Baseline|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
54748|NCT02243176|B1|Baseline|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
54749|NCT02243176|P2|Participant Flow|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
54750|NCT02243176|P1|Participant Flow|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
54751|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
54752|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
54753|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
54754|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
54755|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
54756|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
54777|NCT02243046|P1|Participant Flow|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
54757|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
54758|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
54759|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
54760|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
54761|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
54762|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
54763|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
54764|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
54765|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
54766|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
54767|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
54768|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
54769|NCT02243176|E2|Reported Event|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
54770|NCT02243176|E1|Reported Event|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
54771|NCT02243046|B4|Baseline|Total|Total of all reporting groups
54772|NCT02243046|B3|Baseline|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
54773|NCT02243046|B2|Baseline|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
54774|NCT02243046|B1|Baseline|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
54775|NCT02243046|P3|Participant Flow|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
54776|NCT02243046|P2|Participant Flow|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
54778|NCT02243046|O3|Outcome|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
54779|NCT02243046|O2|Outcome|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
54780|NCT02243046|O1|Outcome|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
54781|NCT02243046|O3|Outcome|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
54782|NCT02243046|O2|Outcome|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
54783|NCT02243046|O1|Outcome|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
54784|NCT02243046|O3|Outcome|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
54785|NCT02243046|O2|Outcome|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
54786|NCT02243046|O1|Outcome|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
54787|NCT02243046|O3|Outcome|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
54788|NCT02243046|O2|Outcome|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
54789|NCT02243046|O1|Outcome|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
54790|NCT02243046|O3|Outcome|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
54791|NCT02243046|O2|Outcome|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
54792|NCT02243046|O1|Outcome|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
54793|NCT02243046|O3|Outcome|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
54794|NCT02243046|O2|Outcome|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
54795|NCT02243046|O1|Outcome|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
54796|NCT02243046|E3|Reported Event|Active Comparator|1450 ppm sodium fluoride/triclosan toothpaste Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
54797|NCT02243046|E2|Reported Event|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
87170|NCT02040792|P1|Participant Flow|Placebo|"Placebo~Placebo"
54798|NCT02243046|E1|Reported Event|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
54799|NCT02243007|B3|Baseline|Total|Total of all reporting groups
54800|NCT02243007|B2|Baseline|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
54801|NCT02243007|B1|Baseline|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
54802|NCT02243007|P2|Participant Flow|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
54803|NCT02243007|P1|Participant Flow|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
54804|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
54805|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
54806|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
54807|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
54808|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
54809|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
55062|NCT02240589|O1|Outcome|Memantine|"24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.~Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine."
54810|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
54811|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
54812|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
54813|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
54814|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
54815|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
54816|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
54817|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
54818|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
54819|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
54835|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54877|NCT02242630|O4|Outcome|Triamcinolone, 40 mg|"Triamcinolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone"
54820|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
54821|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
54822|NCT02243007|E2|Reported Event|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
54823|NCT02243007|E1|Reported Event|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
54824|NCT02242994|B1|Baseline|Dynavox Maestro and Experimental App|"Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.~Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.~Experimental App: Participant receives experimental app to test speed and error rate of communication."
54825|NCT02242994|P1|Participant Flow|Dynavox Maestro and Experimental App|"Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.~Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.~Experimental App: Participant receives experimental app to test speed and error rate of communication."
54826|NCT02242994|O1|Outcome|Dynavox Maestro and Experimental App|"Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.~Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.~Experimental App: Participant receives experimental app to test speed and error rate of communication."
54827|NCT02242994|O1|Outcome|Dynavox Maestro and Experimental App|"Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.~Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.~Experimental App: Participant receives experimental app to test speed and error rate of communication."
54828|NCT02242994|E1|Reported Event|Dynavox Maestro and Experimental App|"Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.~Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.~Experimental App: Participant receives experimental app to test speed and error rate of communication."
54829|NCT02242643|B3|Baseline|Total|Total of all reporting groups
54830|NCT02242643|B2|Baseline|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54831|NCT02242643|B1|Baseline|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54832|NCT02242643|P2|Participant Flow|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54833|NCT02242643|P1|Participant Flow|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54834|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54876|NCT02242630|O1|Outcome|Methylprednisolone, 20 mg|"Methylprednisolone, 20 mg, will be injected~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
54836|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54837|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54838|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54839|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54840|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54841|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54842|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54843|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54844|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54845|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54846|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
54847|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
54848|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54849|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54850|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
54851|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
54852|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
54853|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
87171|NCT02040792|O5|Outcome|350 mcg|"TD-4208~TD-4208"
54854|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54855|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54856|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54857|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54858|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54859|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54860|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54861|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54862|NCT02242643|E2|Reported Event|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54863|NCT02242643|E1|Reported Event|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
54864|NCT02242630|B5|Baseline|Total|Total of all reporting groups
54865|NCT02242630|B4|Baseline|Triamcinolone, 40 mg|"Triamcinolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone"
54866|NCT02242630|B3|Baseline|Triamcinolone, 20 mg|"Triamcinolone, 20 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
54867|NCT02242630|B2|Baseline|Methylprednisolone, 40 mg|"Methylprednisolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
54868|NCT02242630|B1|Baseline|Methylprednisolone, 20 mg|"Methylprednisolone, 20 mg, will be injected~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
54869|NCT02242630|P4|Participant Flow|Triamcinolone, 40 mg|"Triamcinolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone"
54870|NCT02242630|P3|Participant Flow|Triamcinolone, 20 mg|"Triamcinolone, 20 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
54871|NCT02242630|P2|Participant Flow|Methylprednisolone, 40 mg|"Methylprednisolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
54872|NCT02242630|P1|Participant Flow|Methylprednisolone, 20 mg|"Methylprednisolone, 20 mg, will be injected~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
54873|NCT02242630|O4|Outcome|Triamcinolone, 40 mg|"Triamcinolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone"
54874|NCT02242630|O3|Outcome|Triamcinolone, 20 mg|"Triamcinolone, 20 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
54875|NCT02242630|O2|Outcome|Methylprednisolone, 40 mg|"Methylprednisolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
87172|NCT02040792|O4|Outcome|175 mcg|"TD-4208~TD-4208"
54878|NCT02242630|O3|Outcome|Triamcinolone, 20 mg|"Triamcinolone, 20 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
54879|NCT02242630|O2|Outcome|Methylprednisolone, 40 mg|"Methylprednisolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
54880|NCT02242630|O1|Outcome|Methylprednisolone, 20 mg|"Methylprednisolone, 20 mg, will be injected~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
54881|NCT02242630|E4|Reported Event|Triamcinolone, 40 mg|"Triamcinolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone"
54882|NCT02242630|E3|Reported Event|Triamcinolone, 20 mg|"Triamcinolone, 20 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
54883|NCT02242630|E2|Reported Event|Methylprednisolone, 40 mg|"Methylprednisolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
54884|NCT02242630|E1|Reported Event|Methylprednisolone, 20 mg|"Methylprednisolone, 20 mg, will be injected~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
54885|NCT02242305|B3|Baseline|Total|Total of all reporting groups
54886|NCT02242305|B2|Baseline|Hyoscine Butylbromide - Capsule|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
54887|NCT02242305|B1|Baseline|Hyoscine Butylbromide - Tablet|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
54888|NCT02242305|P2|Participant Flow|Hyoscine Butylbromide - Capsule (Cap.)|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
54889|NCT02242305|P1|Participant Flow|Hyoscine Butylbromide - Tablet (Tab.)|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
54890|NCT02242305|O2|Outcome|Hyoscine Butylbromide - Capsule|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
54891|NCT02242305|O1|Outcome|Hyoscine Butylbromide - Tablet|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
54892|NCT02242305|O2|Outcome|Hyoscine Butylbromide – Capsule|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
54893|NCT02242305|O1|Outcome|Hyoscine Butylbromide – Tablet|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
54894|NCT02242305|O2|Outcome|Hyoscine Butylbromide - Capsule|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
54895|NCT02242305|O1|Outcome|Hyoscine Butylbromide - Tablet|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
54896|NCT02242305|O2|Outcome|Hyoscine Butylbromide - Capsule|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
54897|NCT02242305|O1|Outcome|Hyoscine Butylbromide - Tablet|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
54898|NCT02242305|O2|Outcome|Hyoscine Butylbromide - Capsule|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
54899|NCT02242305|O1|Outcome|Hyoscine Butylbromide - Tablet|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
54900|NCT02242305|O2|Outcome|Hyoscine Butylbromide - Capsule|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
54901|NCT02242305|O1|Outcome|Hyoscine Butylbromide - Tablet|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
54902|NCT02242305|O2|Outcome|Hyoscine Butylbromide - Capsule|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
54903|NCT02242305|O1|Outcome|Hyoscine Butylbromide - Tablet|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
54904|NCT02242305|E2|Reported Event|Hyoscine Butylbromide - Capsule|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
54905|NCT02242305|E1|Reported Event|Hyoscine Butylbromide - Tablet|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
54906|NCT02242201|B4|Baseline|Total|Total of all reporting groups
54907|NCT02242201|B3|Baseline|PAI Liposomal Bupivacaine|"Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.~PAI liposomal bupivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
54908|NCT02242201|B2|Baseline|PAI Ropivacaine|"Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.~PAI Ropivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
55098|NCT02240030|P1|Participant Flow|CVT-301 Low Dose|"Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration~CVT-301"
54909|NCT02242201|B1|Baseline|PNB Bupivacaine|"Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.~PNB Bupivacaine: Infusion~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg"
54910|NCT02242201|P3|Participant Flow|PAI Liposomal Bupivacaine|"Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.~PAI liposomal bupivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
54911|NCT02242201|P2|Participant Flow|PAI Ropivacaine|"Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.~Periarticular infiltration (PAI) Ropivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
54912|NCT02242201|P1|Participant Flow|PNB Bupivacaine|"Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.~Posterior lumbar plexus block (PNB) Bupivacaine: Infusion~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg"
54913|NCT02242201|O3|Outcome|PAI Liposomal Bupivacaine|"Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.~PAI liposomal bupivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
54914|NCT02242201|O2|Outcome|PAI Ropivacaine|"Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.~PAI Ropivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
54915|NCT02242201|O1|Outcome|PNB Bupivacaine|"Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.~PNB Bupivacaine: Infusion~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg"
54916|NCT02242201|O3|Outcome|PAI Liposomal Bupivacaine|"Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.~PAI liposomal bupivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
54917|NCT02242201|O2|Outcome|PAI Ropivacaine|"Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.~PAI Ropivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
54918|NCT02242201|O1|Outcome|PNB Bupivacaine|"Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.~PNB Bupivacaine: Infusion~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg"
54919|NCT02242201|O3|Outcome|PAI Liposomal Bupivacaine|"Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.~PAI liposomal bupivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
54920|NCT02242201|O2|Outcome|PAI Ropivacaine|"Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.~PAI Ropivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
54921|NCT02242201|O1|Outcome|PNB Bupivacaine|"Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.~PNB Bupivacaine: Infusion~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg"
54922|NCT02242201|O3|Outcome|PAI Liposomal Bupivacaine|"Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.~PAI liposomal bupivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
54923|NCT02242201|O2|Outcome|PAI Ropivacaine|"Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.~PAI Ropivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
54924|NCT02242201|O1|Outcome|PNB Bupivacaine|"Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.~PNB Bupivacaine: Infusion~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg"
54925|NCT02242201|O3|Outcome|PAI Liposomal Bupivacaine|"Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.~PAI liposomal bupivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
54926|NCT02242201|O2|Outcome|PAI Ropivacaine|"Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.~PAI Ropivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
54927|NCT02242201|O1|Outcome|PNB Bupivacaine|"Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.~PNB Bupivacaine: Infusion~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg"
54928|NCT02242201|O3|Outcome|PAI Liposomal Bupivacaine|"Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.~PAI liposomal bupivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
54929|NCT02242201|O2|Outcome|PAI Ropivacaine|"Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.~PAI Ropivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
54930|NCT02242201|O1|Outcome|PNB Bupivacaine|"Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.~PNB Bupivacaine: Infusion~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg"
56311|NCT02230670|O1|Outcome|IDN-6556|"25 mg BID of IDN-6556~IDN-6556: 25 mg BID"
54931|NCT02242201|O3|Outcome|PAI Liposomal Bupivacaine|"Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.~PAI liposomal bupivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
54932|NCT02242201|O2|Outcome|PAI Ropivacaine|"Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.~PAI Ropivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
54933|NCT02242201|O1|Outcome|PNB Bupivacaine|"Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.~PNB Bupivacaine: Infusion~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg"
54934|NCT02242201|O3|Outcome|PAI Liposomal Bupivacaine|"Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.~PAI liposomal bupivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
54935|NCT02242201|O2|Outcome|PAI Ropivacaine|"Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.~PAI Ropivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
54936|NCT02242201|O1|Outcome|PNB Bupivacaine|"Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.~PNB Bupivacaine: Infusion~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg"
54937|NCT02242201|O3|Outcome|PAI Liposomal Bupivacaine|"Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.~PAI liposomal bupivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
54938|NCT02242201|O2|Outcome|PAI Ropivacaine|"Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.~PAI Ropivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
54939|NCT02242201|O1|Outcome|PNB Bupivacaine|"Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.~PNB Bupivacaine: Infusion~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg"
54940|NCT02242201|E3|Reported Event|PAI Liposomal Bupivacaine|"Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.~PAI liposomal bupivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
54941|NCT02242201|E2|Reported Event|PAI Ropivacaine|"Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.~PAI Ropivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
54942|NCT02242201|E1|Reported Event|PNB Bupivacaine|"Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.~PNB Bupivacaine: Infusion~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg"
54943|NCT02242019|B1|Baseline|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
54944|NCT02242019|P1|Participant Flow|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
54945|NCT02242019|O1|Outcome|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
54946|NCT02242019|O1|Outcome|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
54947|NCT02242019|O1|Outcome|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
54948|NCT02242019|E1|Reported Event|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
54949|NCT02241889|B1|Baseline|All Study Participants|All study participants underwent three 21 hour study visits using either standard of care insulin pump therapy, closed loop control, or closed loop control with adjustments to insulin and glucagon after exercise announcement. Treatment order was randomized.
54950|NCT02241889|P6|Participant Flow|APX, APN, SAP (21 Hours)|The randomization order for subjects in this arm was closed loop with exercise announcement (APX), closed loop (APN) and open loop (Sensor Augmented Pump SAP). Each visit was 21 hours.
54951|NCT02241889|P5|Participant Flow|APX, SAP, APN (21 Hours)|The randomization order for subjects in this arm was closed loop with exercise announcement (APX), open loop (Sensor Augmented Pump SAP) and closed loop (APN). Each visit was 21 hours.
54952|NCT02241889|P4|Participant Flow|APN, APX, SAP (21 Hours)|The randomization order for subjects in this arm was closed loop (APN), closed loop with exercise announcement (APX), and open loop (Sensor Augmented Pump SAP). Each visit was 21 hours.
54953|NCT02241889|P3|Participant Flow|APN, SAP and APX (21 Hours)|The randomization order for subjects in this arm was closed loop (APN), open loop (Sensor Augmented Pump SAP), and closed loop with exercise announcement (APX). Each visit was 21 hours.
54954|NCT02241889|P2|Participant Flow|SAP, APX, APN (21 Hours)|The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), closed loop with exercise announcement (APX), and closed loop (APN). Each visit was 21 hours.
54955|NCT02241889|P1|Participant Flow|SAP, APN, APX (21 Hours)|The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), closed loop (APN) and closed loop with exercise announcement (APX). Each visit was 21 hours.
55099|NCT02240030|O3|Outcome|Placebo|"Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.~CVT-301"
54956|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
54957|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
54958|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.~Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
54959|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
54960|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
54961|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.~Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
54962|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
54963|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
54964|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.~Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
54965|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
54966|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
54967|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.~Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
54968|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
54969|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
54970|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.~Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
56312|NCT02230670|O2|Outcome|Placebo|"Placebo BID~Placebo"
54971|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
54972|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
54973|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.~Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
54974|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
54975|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
54976|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.~Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
54977|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
54978|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
54979|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.~Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
54980|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
54981|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
54982|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.~Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
54983|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
54984|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
54985|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.~Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
87173|NCT02040792|O3|Outcome|88 mcg|"TD-4208~TD-4208"
54986|NCT02241889|E3|Reported Event|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
54987|NCT02241889|E2|Reported Event|Closed-loop Without Adjustment|"Subjects will undergo 21 study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
54988|NCT02241889|E1|Reported Event|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.~Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
54989|NCT02241785|B1|Baseline|Natalizumab|natalizumab 300 mg IV every 4 weeks
54990|NCT02241785|P1|Participant Flow|Natalizumab|natalizumab 300 mg intravenously (IV) every 4 weeks
54991|NCT02241785|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks
54992|NCT02241785|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks
54993|NCT02241785|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks
54994|NCT02241785|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks
54995|NCT02241785|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks
54996|NCT02241785|E1|Reported Event|Natalizumab|natalizumab 300 mg IV every 4 weeks
54997|NCT02241720|B1|Baseline|Regorafenib Treatment|regorafenib
54998|NCT02241720|P1|Participant Flow|Regorafenib Treatment|160 mg regorafenib by mouth once daily for 3 weeks of every 4 week cycle
54999|NCT02241720|O1|Outcome|Regorafenib Treatment|regorafenib
55000|NCT02241720|E1|Reported Event|Regorafenib Treatment|regorafenib
55001|NCT02241486|B1|Baseline|Sublingual Fentanyl Spray|"Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.~Sublingual Fentanyl Spray: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement)."
55002|NCT02241486|P1|Participant Flow|Sublingual Fentanyl Spray|"Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.~Sublingual Fentanyl Spray: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement)."
55003|NCT02241486|O1|Outcome|Sublingual Fentanyl Spray|"Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.~Sublingual Fentanyl Spray: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement)."
55004|NCT02241486|E1|Reported Event|Sublingual Fentanyl Spray|"Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.~Sublingual Fentanyl Spray: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement)."
55005|NCT02241187|B1|Baseline|PEGPH20 And Cetuximab|"Participants have radiographically resectable Pancreatic ductal adenocarcinoma (PDAC) without evidence of distant metastases by CT or laparoscopy.~However, the two participants accrued to this study were healthy participants."
55006|NCT02241187|P1|Participant Flow|PEGPH20 And Cetuximab|"5 participants will undergo DW- & DCE-MRI for sequence parameter optimization. The 1st stage of the study, patients (n = 5) will have the option to undergo (DW-) & (DCE)-MRI for repeatability investigation & T1 mapping. Optional DW- & DCE-MRI will be repeated 2 to 5 days later, followed shortly by administration of 1 intravenous dose of cetuximab at 250 mg/m2/60 min. Pancreatic tumor resection will be performed 1 to 2 days later.Blood samples will be drawn at various time points. The resected tumor specimen will be studied. If deemed safe, we will proceed to the second stage of the study. Patients (n = 5) will have the option to undergo DW- & DCE-MRI. 1 to 3 days later, patients will receive 1 IV dose of PEGPH20 at 3 μg/kg/10 min. Optional DW- & DCE-MRI will be repeated 1 to 2 days after PEGPH20 administration, followed on that day by administration of 1 IV dose of cetuximab at 250 mg/m2/60 min. Pancreatic tumor resection will be performed 1 to 2 days later.~PEGPH20~Cetuximab"
55007|NCT02241187|O1|Outcome|PEGPH20 And Cetuximab|"Participants have radiographically resectable Pancreatic ductal adenocarcinoma (PDAC) without evidence of distant metastases by CT or laparoscopy.~However, the two participants accrued to this study were healthy participants."
55008|NCT02241187|O1|Outcome|PEGPH20 And Cetuximab|"Participants have radiographically resectable Pancreatic ductal adenocarcinoma (PDAC) without evidence of distant metastases by CT or laparoscopy.~However, the two participants accrued to this study were healthy participants."
55009|NCT02241187|E1|Reported Event|PEGPH20 And Cetuximab|"Participants have radiographically resectable Pancreatic ductal adenocarcinoma (PDAC) without evidence of distant metastases by CT or laparoscopy.~All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were NOT monitored/assessed."
55010|NCT02240654|B6|Baseline|Total|Total of all reporting groups
55011|NCT02240654|B5|Baseline|Dabigatran Etexilate (Pradaxa®)_UK (HES Non-linkable)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK) non-linkable HES (primary care information)
55012|NCT02240654|B4|Baseline|Dabigatran Etexilate (Pradaxa®)_UK (HES Linkable)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK) Hospital Episode Statistics (HES) linkable (primary care information, hospital episodes, dispensed ambulatory medications)
55013|NCT02240654|B3|Baseline|Dabigatran Etexilate (Pradaxa®)_Denmark|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in National Health Databases in Denmark (DK) (hospital episodes, dispensed ambulatory medications)
55014|NCT02240654|B2|Baseline|Dabigatran Etexilate (Pradaxa®)_France (GPs)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) identified from panels of general practitioners (GPs) in Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD) in France (primary care information)
55015|NCT02240654|B1|Baseline|Dabigatran Etexilate (Pradaxa®)_France (Cardiologists)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) identified from panels of cardiologists in Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD) in France (primary care information)
55016|NCT02240654|P5|Participant Flow|Dabigatran Etexilate (Pradaxa®)_UK (HES Non-linkable)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK) non-linkable HES (primary care information)
55017|NCT02240654|P4|Participant Flow|Dabigatran Etexilate (Pradaxa®)_UK (HES Linkable)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK) Hospital Episode Statistics (HES) linkable (primary care information, hospital episodes, dispensed ambulatory medications)
55018|NCT02240654|P3|Participant Flow|Dabigatran Etexilate (Pradaxa®)_Denmark|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in National Health Databases in Denmark (DK) (hospital episodes, dispensed ambulatory medications)
55019|NCT02240654|P2|Participant Flow|Dabigatran Etexilate (Pradaxa®)_France (GPs)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) identified from panels of general practitioners (GPs) in Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD) in France (primary care information)
55020|NCT02240654|P1|Participant Flow|Dabigatran Etexilate (Pradaxa®)_France (Cardiologists)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) identified from panels of cardiologists in Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD) in France (primary care information)
55021|NCT02240654|O5|Outcome|Dabigatran Etexilate (Pradaxa®)_UK (HES Non-linkable)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK) non-linkable HES (primary care information)
55022|NCT02240654|O4|Outcome|Dabigatran Etexilate (Pradaxa®)_UK (HES Linkable)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK) Hospital Episode Statistics (HES) linkable (primary care information, hospital episodes, dispensed ambulatory medications)
55023|NCT02240654|O3|Outcome|Dabigatran Etexilate (Pradaxa®)_Denmark|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in National Health Databases in Denmark (DK) (hospital episodes, dispensed ambulatory medications)
55024|NCT02240654|O2|Outcome|Dabigatran Etexilate (Pradaxa®)_France (GPs)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) identified from panels of general practitioners (GPs) in Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD) in France (primary care information)
55025|NCT02240654|O1|Outcome|Dabigatran Etexilate (Pradaxa®)_France (Cardiologists)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) identified from panels of cardiologists in Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD) in France (primary care information)
55026|NCT02240654|E5|Reported Event|Dabigatran Etexilate (Pradaxa®)_UK (HES Non-linkable)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK) non-linkable HES (primary care information)
55027|NCT02240654|E4|Reported Event|Dabigatran Etexilate (Pradaxa®)_UK (HES Linkable)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK) Hospital Episode Statistics (HES) linkable (primary care information, hospital episodes, dispensed ambulatory medications)
55028|NCT02240654|E3|Reported Event|Dabigatran Etexilate (Pradaxa®)_Denmark|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in National Health Databases in Denmark (DK) (hospital episodes, dispensed ambulatory medications)
55029|NCT02240654|E2|Reported Event|Dabigatran Etexilate (Pradaxa®)_France (GPs)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) identified from panels of general practitioners (GPs) in Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD) in France (primary care information)
55030|NCT02240654|E1|Reported Event|Dabigatran Etexilate (Pradaxa®)_France (Cardiologists)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) identified from panels of cardiologists in Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD) in France (primary care information)
55031|NCT02240628|B3|Baseline|Total|Total of all reporting groups
55032|NCT02240628|B2|Baseline|Propofol -Saline Mixture|"All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Saline: Patients in arm 2 will receive Saline with the Propofol."
55033|NCT02240628|B1|Baseline|Propofol-Lidocaine Mixture|"All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol."
55034|NCT02240628|P2|Participant Flow|Propofol -Saline Mixture|"All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Saline: Patients in arm 2 will receive Saline with the Propofol."
55035|NCT02240628|P1|Participant Flow|Propofol-Lidocaine Mixture|"All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol."
55061|NCT02240589|O2|Outcome|Placebo|"24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.~Placebo: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo."
55036|NCT02240628|O2|Outcome|Propofol -Saline Mixture|"All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Saline: Patients in arm 2 will receive Saline with the Propofol."
55037|NCT02240628|O1|Outcome|Propofol-Lidocaine Mixture|"All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol."
55038|NCT02240628|O2|Outcome|Propofol -Saline Mixture|"All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Saline: Patients in arm 2 will receive Saline with the Propofol."
55039|NCT02240628|O1|Outcome|Propofol-Lidocaine Mixture|"All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol."
55040|NCT02240628|E2|Reported Event|Propofol -Saline Mixture|"All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Saline: Patients in arm 2 will receive Saline with the Propofol."
55041|NCT02240628|E1|Reported Event|Propofol-Lidocaine Mixture|"All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol."
55042|NCT02240589|B3|Baseline|Total|Total of all reporting groups
55043|NCT02240589|B2|Baseline|Placebo|"24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.~Placebo: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo."
55044|NCT02240589|B1|Baseline|Memantine|"24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.~Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine."
55045|NCT02240589|P2|Participant Flow|Placebo|"24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.~Placebo: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo."
55046|NCT02240589|P1|Participant Flow|Memantine|"24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.~Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine."
55047|NCT02240589|O2|Outcome|Placebo|"24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.~Placebo: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo."
55048|NCT02240589|O1|Outcome|Memantine|"24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.~Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine."
55049|NCT02240589|O2|Outcome|Placebo|"24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.~Placebo: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo."
55050|NCT02240589|O1|Outcome|Memantine|"24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.~Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine."
55051|NCT02240589|O2|Outcome|Placebo|"24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.~Placebo: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo."
55052|NCT02240589|O1|Outcome|Memantine|"24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.~Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine."
55053|NCT02240589|O2|Outcome|Placebo|"24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.~Placebo: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo."
55054|NCT02240589|O1|Outcome|Memantine|"24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.~Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine."
55055|NCT02240589|O2|Outcome|Placebo|"24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.~Placebo: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo."
55056|NCT02240589|O1|Outcome|Memantine|"24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.~Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine."
55057|NCT02240589|O2|Outcome|Placebo|"24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.~Placebo: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo."
55058|NCT02240589|O1|Outcome|Memantine|"24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.~Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine."
55059|NCT02240589|O2|Outcome|Placebo|"24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.~Placebo: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo."
55060|NCT02240589|O1|Outcome|Memantine|"24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.~Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine."
55100|NCT02240030|O2|Outcome|CVT-301 High Dose|"Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration~CVT-301"
55063|NCT02240589|E2|Reported Event|Placebo|"24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.~Placebo: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo."
55064|NCT02240589|E1|Reported Event|Memantine|"24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.~Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine."
55065|NCT02240368|B4|Baseline|Total|Total of all reporting groups
55066|NCT02240368|B3|Baseline|Group 3|Children age between 37 months to 144 months
55067|NCT02240368|B2|Baseline|Group 2|Children age between 13 months and 36 months
55068|NCT02240368|B1|Baseline|Group 1|Children age between 1 month to 12 months
55069|NCT02240368|P3|Participant Flow|Group 3|Children age between 37 months to 144 months
55070|NCT02240368|P2|Participant Flow|Group 2|Children age between 13 months and 36 months
55071|NCT02240368|P1|Participant Flow|Group 1|Children age between 1 month to 12 months
55072|NCT02240368|O3|Outcome|Group 3|Children age between 37 months to 144 months
55073|NCT02240368|O2|Outcome|Group 2|Children age between 13 months and 36 months
55074|NCT02240368|O1|Outcome|Group 1|Children age between 1 month to 12 months
55075|NCT02240368|O3|Outcome|Group 3|Children age between 37 months to 144 months
55076|NCT02240368|O2|Outcome|Group 2|Children age between 13 months and 36 months
55077|NCT02240368|O1|Outcome|Group 1|Children age between 1 month to 12 months
55078|NCT02240368|O3|Outcome|Group 3|Children age between 37 months to 144 months
55079|NCT02240368|O2|Outcome|Group 2|Children age between 13 months and 36 months
55080|NCT02240368|O1|Outcome|Group 1|Children age between 1 month to 12 months
55081|NCT02240368|O3|Outcome|Group 3|Children age between 37 months to 144 months
55082|NCT02240368|O2|Outcome|Group 2|Children age between 13 months and 36 months
55083|NCT02240368|O1|Outcome|Group 1|Children age between 1 month to 12 months
55084|NCT02240368|E3|Reported Event|Group 3|Children age between 37 months to 144 months
55085|NCT02240368|E2|Reported Event|Group 2|Children age between 13 months and 36 months
55086|NCT02240368|E1|Reported Event|Group 1|Children age between 1 month to 12 months
55087|NCT02240329|B1|Baseline|Individuals With TBI|"Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.~Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.~Respiratory measures: We will collect measures of cough airflow and breathing strength.~Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is."
55088|NCT02240329|P1|Participant Flow|Individuals With TBI|"Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.~Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.~Respiratory measures: We will collect measures of cough airflow and breathing strength.~Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is."
55089|NCT02240329|O1|Outcome|Individuals With TBI|"Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.~Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.~Respiratory measures: We will collect measures of cough airflow and breathing strength.~Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is."
55090|NCT02240329|O1|Outcome|Individuals With TBI|"Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.~Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.~Respiratory measures: We will collect measures of cough airflow and breathing strength.~Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is."
55091|NCT02240329|E1|Reported Event|Individuals With TBI|"Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.~Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.~Respiratory measures: We will collect measures of cough airflow and breathing strength.~Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is."
55092|NCT02240030|B4|Baseline|Total|Total of all reporting groups
55093|NCT02240030|B3|Baseline|Placebo|"Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.~CVT-301"
55094|NCT02240030|B2|Baseline|CVT-301 High Dose|"Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration~CVT-301"
55095|NCT02240030|B1|Baseline|CVT-301 Low Dose|"Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration~CVT-301"
55096|NCT02240030|P3|Participant Flow|Placebo|"Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.~CVT-301"
55097|NCT02240030|P2|Participant Flow|CVT-301 High Dose|"Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration~CVT-301"
55101|NCT02240030|O1|Outcome|CVT-301 Low Dose|"Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration~CVT-301"
55102|NCT02240030|O3|Outcome|Placebo|"Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.~CVT-301"
55103|NCT02240030|O2|Outcome|CVT-301 High Dose|"Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration~CVT-301"
55104|NCT02240030|O1|Outcome|CVT-301 Low Dose|"Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration~CVT-301"
55105|NCT02240030|O3|Outcome|Placebo|"Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.~CVT-301"
55106|NCT02240030|O2|Outcome|CVT-301 High Dose|"Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration~CVT-301"
55107|NCT02240030|O1|Outcome|CVT-301 Low Dose|"Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration~CVT-301"
55108|NCT02240030|O3|Outcome|Placebo|"Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.~CVT-301"
55109|NCT02240030|O2|Outcome|CVT-301 High Dose|"Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration~CVT-301"
55110|NCT02240030|O1|Outcome|CVT-301 Low Dose|"Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration~CVT-301"
55111|NCT02240030|O3|Outcome|Placebo|"Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.~CVT-301"
55112|NCT02240030|O2|Outcome|CVT-301 High Dose|"Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration~CVT-301"
55113|NCT02240030|O1|Outcome|CVT-301 Low Dose|"Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration~CVT-301"
55114|NCT02240030|O2|Outcome|Placebo|"Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.~CVT-301"
55115|NCT02240030|O1|Outcome|CVT-301 High Dose|"Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration~CVT-301"
55116|NCT02240030|E3|Reported Event|Placebo|"Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.~CVT-301"
55117|NCT02240030|E2|Reported Event|CVT-301 High Dose|"Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration~CVT-301"
55118|NCT02240030|E1|Reported Event|CVT-301 Low Dose|"Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration~CVT-301"
55119|NCT02239978|B3|Baseline|Total|Total of all reporting groups
55120|NCT02239978|B2|Baseline|Control|"Age-matched healthy adults~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
55121|NCT02239978|B1|Baseline|Parkinsons Disease|"Individuals with Parkinsons disease~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
55122|NCT02239978|P2|Participant Flow|Control|"Age-matched healthy adults~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
55123|NCT02239978|P1|Participant Flow|Parkinsons Disease|"Individuals with Parkinsons disease~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
55124|NCT02239978|O2|Outcome|Parkinson's Disease Off Medication|"These are the same participants as in the Parkinson's disease group, assessed Off their levodopa medication"
55125|NCT02239978|O1|Outcome|Parkinsons Disease|"Individuals with Parkinsons disease~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
55126|NCT02239978|O3|Outcome|Parkinson's Disease Off Medication|"These are the same individuals in the Parkinson's disease group, but Off their levodopa"
55127|NCT02239978|O2|Outcome|Control|"Age-matched healthy adults~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
55128|NCT02239978|O1|Outcome|Parkinsons Disease|"Individuals with Parkinsons disease~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
55129|NCT02239978|O3|Outcome|Parkinson's Disease Off Medication|"These are the same individuals in the Parkinson's disease group, but Off their levodopa"
55130|NCT02239978|O2|Outcome|Control|"Age-matched healthy adults~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
55131|NCT02239978|O1|Outcome|Parkinsons Disease|"Individuals with Parkinsons disease~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
55132|NCT02239978|O3|Outcome|Parkinson's Disease Off Medication|"These are the same individuals in the Parkinson's disease group, but Off their levodopa"
55133|NCT02239978|O2|Outcome|Control|"Age-matched healthy adults~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
55422|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
55134|NCT02239978|O1|Outcome|Parkinsons Disease|"Individuals with Parkinsons disease~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
55135|NCT02239978|E2|Reported Event|Control|"Age-matched healthy adults~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
55136|NCT02239978|E1|Reported Event|Parkinsons Disease|"Individuals with Parkinsons disease~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
55137|NCT02239939|B3|Baseline|Total|Total of all reporting groups
55138|NCT02239939|B2|Baseline|No Vest + Diet|"All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.~Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame."
55139|NCT02239939|B1|Baseline|Vest + Diet|"All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for >10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.~Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to~Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame."
55140|NCT02239939|P2|Participant Flow|No Vest + Diet|"All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.~Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame."
55141|NCT02239939|P1|Participant Flow|Vest + Diet|"All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for >10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.~Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to~Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame."
55142|NCT02239939|O2|Outcome|No Vest + Diet|"All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.~Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame."
55143|NCT02239939|O1|Outcome|Vest + Diet|"All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for >10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.~Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to~Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame."
55144|NCT02239939|O2|Outcome|No Vest + Diet|"All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.~Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame."
55145|NCT02239939|O1|Outcome|Vest + Diet|"All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for >10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.~Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to~Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame."
55169|NCT02239744|P1|Participant Flow|Sham Purifiers First, Then True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. In the first period, this group used sham air purifiers with the only difference being removal of the filter gauze. In the second period, this group used true air purifiers.
55170|NCT02239744|O2|Outcome|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
55146|NCT02239939|O2|Outcome|No Vest + Diet|"All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.~Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame."
55147|NCT02239939|O1|Outcome|Vest + Diet|"All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for >10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.~Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to~Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame."
55148|NCT02239939|O2|Outcome|No Vest + Diet|"All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.~Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame."
55149|NCT02239939|O1|Outcome|Vest + Diet|"All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for >10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.~Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to~Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame."
55150|NCT02239939|O2|Outcome|No Vest+Diet|"All participants will undergo a 22 week dietary weight loss.~Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame."
55151|NCT02239939|O1|Outcome|Diet+Vest|"All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for >10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.~Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to~Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame."
55152|NCT02239939|E2|Reported Event|No Vest + Diet|"All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.~Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame."
55153|NCT02239939|E1|Reported Event|Vest + Diet|"All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for >10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.~Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to~Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame."
55154|NCT02239926|B3|Baseline|Total|Total of all reporting groups
55155|NCT02239926|B2|Baseline|Placebo|Placebo
55156|NCT02239926|B1|Baseline|Ranolazine|tablet, 1000 mg twice daily for four weeks
55157|NCT02239926|P2|Participant Flow|Placebo|Placebo
55158|NCT02239926|P1|Participant Flow|Ranolazine|tablet, 1000 mg twice daily for four weeks
55159|NCT02239926|O2|Outcome|Placebo|Placebo
55160|NCT02239926|O1|Outcome|Ranolazine|tablet, 1000 mg twice daily for four weeks
55161|NCT02239926|O2|Outcome|Placebo|Placebo
55162|NCT02239926|O1|Outcome|Ranolazine|tablet, 1000 mg twice daily for four weeks
55163|NCT02239926|E2|Reported Event|Placebo|Placebo
55164|NCT02239926|E1|Reported Event|Ranolazine|tablet, 1000 mg twice daily for four weeks
55165|NCT02239744|B3|Baseline|Total|Total of all reporting groups
55166|NCT02239744|B2|Baseline|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
55167|NCT02239744|B1|Baseline|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze.
55168|NCT02239744|P2|Participant Flow|True Purifiers First, Then Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. In the first period, this group used true air purifiers.In the second period, this group used sham air purifiers.
87174|NCT02040792|O2|Outcome|44 mcg|"TD-4208~TD-4208"
55171|NCT02239744|O1|Outcome|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze.
55172|NCT02239744|O2|Outcome|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
55173|NCT02239744|O1|Outcome|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze
55174|NCT02239744|O2|Outcome|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
55175|NCT02239744|O1|Outcome|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze
55176|NCT02239744|O2|Outcome|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
55177|NCT02239744|O1|Outcome|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze
55178|NCT02239744|E2|Reported Event|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
55179|NCT02239744|E1|Reported Event|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze.
55180|NCT02239692|B3|Baseline|Total|Total of all reporting groups
55181|NCT02239692|B2|Baseline|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
55182|NCT02239692|B1|Baseline|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
55183|NCT02239692|P2|Participant Flow|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
55184|NCT02239692|P1|Participant Flow|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
55185|NCT02239692|O2|Outcome|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
55186|NCT02239692|O1|Outcome|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
55187|NCT02239692|O2|Outcome|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
55188|NCT02239692|O1|Outcome|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
55189|NCT02239692|O2|Outcome|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
55190|NCT02239692|O1|Outcome|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
55191|NCT02239692|O2|Outcome|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
55192|NCT02239692|O1|Outcome|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
55193|NCT02239692|O2|Outcome|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
55194|NCT02239692|O1|Outcome|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
55195|NCT02239692|O2|Outcome|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
55196|NCT02239692|O1|Outcome|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
55197|NCT02239692|E2|Reported Event|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
55198|NCT02239692|E1|Reported Event|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
55199|NCT02239679|B4|Baseline|Total|Total of all reporting groups
55200|NCT02239679|B3|Baseline|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55201|NCT02239679|B2|Baseline|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55202|NCT02239679|B1|Baseline|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55203|NCT02239679|P3|Participant Flow|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10 mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55204|NCT02239679|P2|Participant Flow|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10 mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55205|NCT02239679|P1|Participant Flow|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + blue light (BLU-U) treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10 mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable actinic keratosis (AK) lesions at screening."
55206|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55207|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55208|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55209|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55210|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55211|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55212|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55213|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55214|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55215|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55216|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55217|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55218|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55219|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55220|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55221|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55222|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55223|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55224|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55225|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55226|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55227|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55228|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55229|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55230|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55231|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55232|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55233|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55416|NCT02239289|B1|Baseline|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
55234|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55235|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55236|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55237|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55238|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55239|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55240|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55241|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55242|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55243|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55244|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55245|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55246|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55247|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55248|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55249|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55250|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
87175|NCT02040792|O1|Outcome|Placebo|"Placebo~Placebo"
55251|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55252|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55253|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55254|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55255|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55256|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55257|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55258|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55259|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55260|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55261|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55262|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55263|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55264|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55265|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55266|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55417|NCT02239289|P1|Participant Flow|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
55267|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55268|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55269|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55270|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55271|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55272|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55273|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55274|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55275|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55276|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55277|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55278|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55279|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55280|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55281|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55282|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55283|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
87176|NCT02040792|E5|Reported Event|350 mcg|"TD-4208~TD-4208"
55284|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55285|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55286|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55287|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55288|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55289|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55290|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55291|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55292|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55293|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55294|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55295|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55296|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55297|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55298|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55299|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55418|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
55300|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55301|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55302|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55303|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55304|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55305|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55306|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55307|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55308|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55309|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55310|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55311|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55312|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55313|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55314|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55315|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55316|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
87177|NCT02040792|E4|Reported Event|175 mcg|"TD-4208~TD-4208"
55317|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55318|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55319|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55320|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55321|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55322|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55323|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55324|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55325|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55326|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55327|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55328|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55329|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55330|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55331|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55332|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55419|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
55333|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55334|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55335|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55336|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55337|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55338|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55339|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55340|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55341|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55342|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55343|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55344|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55345|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55346|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55347|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55348|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55349|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
87178|NCT02040792|E3|Reported Event|88 mcg|"TD-4208~TD-4208"
55350|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55351|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55352|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55353|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55354|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55355|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55356|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55357|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55358|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55359|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55360|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55361|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55362|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55363|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55364|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55365|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55420|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
55366|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55367|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55368|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55369|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55370|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55371|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55372|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55373|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55374|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55375|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55376|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55377|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55378|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55379|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55380|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55381|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55382|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
87179|NCT02040792|E2|Reported Event|44 mcg|"TD-4208~TD-4208"
55383|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55384|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55385|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55386|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55387|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55388|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55389|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55390|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55391|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55392|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55393|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55394|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55395|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55396|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55397|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55398|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55421|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
55399|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55400|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55401|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55402|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55403|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55404|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55405|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55406|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55407|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55408|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55409|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55410|NCT02239679|O3|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55411|NCT02239679|O2|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55412|NCT02239679|O1|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55413|NCT02239679|E3|Reported Event|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55414|NCT02239679|E2|Reported Event|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55415|NCT02239679|E1|Reported Event|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
55423|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
55424|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
55425|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
55426|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
55427|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
55428|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
55429|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
55430|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
55431|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
55432|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
55433|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
55434|NCT02239289|E1|Reported Event|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
55435|NCT02239094|B1|Baseline|Lurasidone (Latuda)|"All study participants will receive open-label Latuda.~Lurasidone (Latuda): Antipsychotic medication approved for use with Bipolar disorder"
55436|NCT02239094|P1|Participant Flow|Lurasidone (Latuda)|"All study participants will receive open-label Latuda.~Lurasidone (Latuda): Antipsychotic medication approved for use with Bipolar disorder"
55437|NCT02239094|O1|Outcome|Lurasidone (Latuda)|"All study participants will receive open-label Latuda.~Lurasidone (Latuda): Antipsychotic medication approved for use with Bipolar disorder"
55438|NCT02239094|O1|Outcome|Lurasidone (Latuda)|"All study participants will receive open-label Latuda.~Lurasidone (Latuda): Antipsychotic medication approved for use with Bipolar disorder"
55439|NCT02239094|E1|Reported Event|Lurasidone (Latuda)|"All study participants will receive open-label Latuda.~Lurasidone (Latuda): Antipsychotic medication approved for use with Bipolar disorder"
55440|NCT02238925|B1|Baseline|CPX-351|"Single Arm Study (Patients may receive up to 2 Inductions and up to 4 Consolidations):~Induction 1: CPX-351 will be given intravenously at 100units/m2 on days 1, 3, and 5 over a 90 minute infusion.~Induction 2: CPX-351 will be given intravenously at 100units/m2 on days 1 and 3 over a 90 minute infusion.~Consolidations: CPX-351 will be given intravenously at 65units/m2 on days 1 and 3 over a 90 minute infusion.~CPX-351"
55441|NCT02238925|P1|Participant Flow|CPX-351|"Single Arm Study (Patients may receive up to 2 Inductions and up to 4 Consolidations):~Induction 1: CPX-351 will be given intravenously at 100units/m2 on days 1, 3, and 5 over a 90 minute infusion.~Induction 2: CPX-351 will be given intravenously at 100units/m2 on days 1 and 3 over a 90 minute infusion.~Consolidations: CPX-351 will be given intravenously at 65units/m2 on days 1 and 3 over a 90 minute infusion.~CPX-351"
55442|NCT02238925|O1|Outcome|CPX-351|"Single Arm Study (Patients may receive up to 2 Inductions and up to 4 Consolidations):~Induction 1: CPX-351 will be given intravenously at 100units/m2 on days 1, 3, and 5 over a 90 minute infusion.~Induction 2: CPX-351 will be given intravenously at 100units/m2 on days 1 and 3 over a 90 minute infusion.~Consolidations: CPX-351 will be given intravenously at 65units/m2 on days 1 and 3 over a 90 minute infusion.~CPX-351"
55443|NCT02238925|O1|Outcome|CPX-351|"Single Arm Study (Patients may receive up to 2 Inductions and up to 4 Consolidations):~Induction 1: CPX-351 will be given intravenously at 100units/m2 on days 1, 3, and 5 over a 90 minute infusion.~Induction 2: CPX-351 will be given intravenously at 100units/m2 on days 1 and 3 over a 90 minute infusion.~Consolidations: CPX-351 will be given intravenously at 65units/m2 on days 1 and 3 over a 90 minute infusion.~CPX-351"
55444|NCT02238925|O1|Outcome|CPX-351|"Single Arm Study (Patients may receive up to 2 Inductions and up to 4 Consolidations):~Induction 1: CPX-351 will be given intravenously at 100units/m2 on days 1, 3, and 5 over a 90 minute infusion.~Induction 2: CPX-351 will be given intravenously at 100units/m2 on days 1 and 3 over a 90 minute infusion.~Consolidations: CPX-351 will be given intravenously at 65units/m2 on days 1 and 3 over a 90 minute infusion.~CPX-351"
55445|NCT02238925|O1|Outcome|CPX-351|"Single Arm Study (Patients may receive up to 2 Inductions and up to 4 Consolidations):~Induction 1: CPX-351 will be given intravenously at 100units/m2 on days 1, 3, and 5 over a 90 minute infusion.~Induction 2: CPX-351 will be given intravenously at 100units/m2 on days 1 and 3 over a 90 minute infusion.~Consolidations: CPX-351 will be given intravenously at 65units/m2 on days 1 and 3 over a 90 minute infusion.~CPX-351"
55446|NCT02238925|O1|Outcome|CPX-351|"Single Arm Study (Patients may receive up to 2 Inductions and up to 4 Consolidations):~Induction 1: CPX-351 will be given intravenously at 100units/m2 on days 1, 3, and 5 over a 90 minute infusion.~Induction 2: CPX-351 will be given intravenously at 100units/m2 on days 1 and 3 over a 90 minute infusion.~Consolidations: CPX-351 will be given intravenously at 65units/m2 on days 1 and 3 over a 90 minute infusion.~CPX-351"
55447|NCT02238925|E1|Reported Event|CPX-351|"Single Arm Study (Patients may receive up to 2 Inductions and up to 4 Consolidations):~Induction 1: CPX-351 will be given intravenously at 100units/m2 on days 1, 3, and 5 over a 90 minute infusion.~Induction 2: CPX-351 will be given intravenously at 100units/m2 on days 1 and 3 over a 90 minute infusion.~Consolidations: CPX-351 will be given intravenously at 65units/m2 on days 1 and 3 over a 90 minute infusion.~CPX-351"
55448|NCT02238782|B1|Baseline|Selumetinib|Patients received a single oral dose of selumetinib 75mg followed by IV carbon 14 selumetinib (80 micrograms) 1 hour 15 minutes after receiving the oral dose.
55449|NCT02238782|P1|Participant Flow|Selumetinib|Patients received a single oral dose of selumetinib 75mg followed by IV carbon 14 selumetinib (80 micrograms) 1 hour 15 minutes after receiving the oral dose.
55450|NCT02238782|O1|Outcome|Selumetinib|Selumetinib 75 mg oral followed by IV carbon 14 selumetinib (80 micrograms) administered 1 hour 15 minutes after the oral dose.
55451|NCT02238782|E1|Reported Event|Selumetinib|Patients received a single oral dose of selumetinib 75mg followed by IV carbon 14 selumetinib (80 micrograms) 1 hour 15 minutes after receiving the oral dose.
55452|NCT02238483|B3|Baseline|Total|Total of all reporting groups
55453|NCT02238483|B2|Baseline|Placebo|Matching placebo comparator
55454|NCT02238483|B1|Baseline|AZD7624|Active treatment 2 x 0.5mg inhalation qd
55455|NCT02238483|P2|Participant Flow|Placebo|Matching placebo comparator
55456|NCT02238483|P1|Participant Flow|AZD7624|Active treatment 2 x 0.5mg inhalation qd
55457|NCT02238483|O2|Outcome|Placebo|Matching placebo comparator
55458|NCT02238483|O1|Outcome|AZD7624|Active treatment 2 x 0.5mg inhalation qd
55459|NCT02238483|O2|Outcome|Placebo|Matching placebo comparator
55460|NCT02238483|O1|Outcome|AZD7624|Active treatment 2 x 0.5mg inhalation qd
55461|NCT02238483|O2|Outcome|Placebo|Matching placebo comparator
55462|NCT02238483|O1|Outcome|AZD7624|Active treatment 2 x 0.5mg inhalation qd
55463|NCT02238483|O2|Outcome|Placebo|Matching placebo comparator
55464|NCT02238483|O1|Outcome|AZD7624|Active treatment 2 x 0.5mg inhalation qd
55465|NCT02238483|O2|Outcome|Placebo|Matching placebo comparator
55466|NCT02238483|O1|Outcome|AZD7624|Active treatment 2 x 0.5mg inhalation qd
55467|NCT02238483|O2|Outcome|Placebo|Matching placebo comparator
55468|NCT02238483|O1|Outcome|AZD7624|Active treatment 2 x 0.5mg inhalation qd
55469|NCT02238483|O2|Outcome|Placebo|Matching placebo comparator
55470|NCT02238483|O1|Outcome|AZD7624|Active treatment 2 x 0.5mg inhalation qd
55471|NCT02238483|O2|Outcome|Placebo|Matching placebo comparator
55472|NCT02238483|O1|Outcome|AZD7624|Active treatment 2 x 0.5mg inhalation qd
55473|NCT02238483|O2|Outcome|Placebo|Matching placebo comparator
55474|NCT02238483|O1|Outcome|AZD7624|Active treatment 2 x 0.5mg inhalation qd
55475|NCT02238483|O2|Outcome|Placebo|Matching placebo comparator
55476|NCT02238483|O1|Outcome|AZD7624|Active treatment 2 x 0.5mg inhalation qd
55477|NCT02238483|O2|Outcome|Placebo|Matching placebo comparator
55478|NCT02238483|O1|Outcome|AZD7624|Active treatment 2 x 0.5mg inhalation qd
55479|NCT02238483|O2|Outcome|Placebo|Matching placebo comparator
55480|NCT02238483|O1|Outcome|AZD7624|Active treatment 2 x 0.5mg inhalation qd
55481|NCT02238483|O2|Outcome|Placebo|Matching placebo comparator
55482|NCT02238483|O1|Outcome|AZD7624|Active treatment 2 x 0.5mg inhalation qd
55483|NCT02238483|O2|Outcome|Placebo|Matching placebo comparator
55484|NCT02238483|O1|Outcome|AZD7624|Active treatment 2 x 0.5mg inhalation qd
55485|NCT02238483|O2|Outcome|Placebo|Matching placebo comparator
55486|NCT02238483|O1|Outcome|AZD7624|Active treatment 2 x 0.5mg inhalation qd
55487|NCT02238483|O2|Outcome|Placebo|Matching placebo comparator
55488|NCT02238483|O1|Outcome|AZD7624|Active treatment 2 x 0.5mg inhalation qd
55489|NCT02238483|E2|Reported Event|Placebo|Matching placebo comparator
55490|NCT02238483|E1|Reported Event|AZD7624|Active treatment 2 x 0.5mg inhalation qd
55491|NCT02238379|B3|Baseline|Total|Total of all reporting groups
55492|NCT02238379|B2|Baseline|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
55493|NCT02238379|B1|Baseline|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
55494|NCT02238379|P2|Participant Flow|Placebo First, Then Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
55495|NCT02238379|P1|Participant Flow|Oxytocin First, Then Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
55496|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
55497|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
55498|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
55499|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
55500|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
55501|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
55502|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
55503|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
87180|NCT02040792|E1|Reported Event|Placebo|"Placebo~Placebo"
55504|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
55505|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
55506|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
55507|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
55508|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
55509|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
55510|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
55511|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
55512|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
55513|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
55514|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
55515|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
55516|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
55517|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
55518|NCT02238379|E2|Reported Event|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
55519|NCT02238379|E1|Reported Event|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
55520|NCT02238080|B1|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
55521|NCT02238080|P1|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and chronic kidney disease (CKD) who were on dialysis therapy, and who initiated erythropoiesis-stimulating agent (ESA) treatment with methoxy polyethylene glycol-epoetin beta (Mircera) or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
55522|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
55523|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
55524|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
55525|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
55526|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
55527|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
55528|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
55529|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
55530|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
55531|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
55532|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
55533|NCT02238080|E1|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
55534|NCT02238067|B1|Baseline|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
55535|NCT02238067|P1|Participant Flow|Chronic Renal Anemia Participants|Participants with Chronic Kidney Disease (CKD) who were not on dialysis and treated with Erythropoiesis-Stimulating Agents (ESA) according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
55536|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
55537|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
55538|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
55539|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
55540|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
55541|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
55542|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
55543|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
55544|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
55545|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
55546|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
55547|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
55616|NCT02236611|B2|Baseline|GLYCO 44 mcg QD|Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
55548|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
55549|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
55550|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
55551|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
55552|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
55553|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
55554|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
55555|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
55556|NCT02238067|E1|Reported Event|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
55557|NCT02238028|B1|Baseline|All Study Participants|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days including a 2-hour walking along the streets on the 2nd day along a fixed route. After a 2-week rest period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days including the 2-hour walking along the streets on the 2nd day along the same fixed route. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
55558|NCT02238028|P2|Participant Flow|Not Wearing Respirator First,Then Wearing Respirator|The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
55559|NCT02238028|P1|Participant Flow|Wearing Respirator First,Then Not Wearing Respirator|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
55560|NCT02238028|O2|Outcome|Not Wear Respirator|The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
55561|NCT02238028|O1|Outcome|Wear Respirator|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
55562|NCT02238028|O2|Outcome|Not Wear Respirator|The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
55614|NCT02236767|E1|Reported Event|TMS Therapy|"NeuroStar TMS Therapy System~Neurostar TMS Therapy System: Treatment will entail daily (5 days/week) sessions of rTMS for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC)."
55563|NCT02238028|O1|Outcome|Wear Respirator|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
55564|NCT02238028|O2|Outcome|Not Wear Respirator|The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
55565|NCT02238028|O1|Outcome|Wear Respirator|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
55566|NCT02238028|O2|Outcome|Not Wear Respirator|The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
55567|NCT02238028|O1|Outcome|Wear Respirator|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
55568|NCT02238028|O2|Outcome|Not Wear Respirator|The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
55569|NCT02238028|O1|Outcome|Wear Respirator|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
55570|NCT02238028|O1|Outcome|All Study Participants|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
55571|NCT02238028|O2|Outcome|Not Wear Respirator|The recruited healthy subjects were randomly allocated into two groups.In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
55572|NCT02238028|O1|Outcome|Wear Respirator|"The recruited healthy subjects were randomly allocated into two groups.In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
55573|NCT02238028|O2|Outcome|Not Wear Respirator|The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
55574|NCT02238028|O1|Outcome|Wear Respirator|"The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
55615|NCT02236611|B3|Baseline|Total|Total of all reporting groups
55575|NCT02238028|E2|Reported Event|Not Wear Respirator|The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
55576|NCT02238028|E1|Reported Event|Wear Respirator|"The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
55577|NCT02237118|B3|Baseline|Total|Total of all reporting groups
55578|NCT02237118|B2|Baseline|UrgoTul|"Pain on dressing removal, by VAS~Mepitel One~UrgoTul"
55579|NCT02237118|B1|Baseline|Mepitel One|"Pain on dressing removal, by VAS~Mepitel One~UrgoTul"
55580|NCT02237118|P2|Participant Flow|UrgoTul|"Pain on removal by VAS~UrgoTul"
55581|NCT02237118|P1|Participant Flow|Mepitel One|"Pain on dressing removal, by VAS~Mepitel One"
55582|NCT02237118|O2|Outcome|UrgoTul|Condition of the surrounding skin
55583|NCT02237118|O1|Outcome|Mepitel One|Condition of the surrounding skin
55584|NCT02237118|O2|Outcome|Safety UrgoTul|Adverse Event and Adverse Device Effect
55585|NCT02237118|O1|Outcome|Safety Mepitel One|Adverse Event and Adverse Device Effect
55586|NCT02237118|O2|Outcome|Condition of the Wound, UrgoTul|Condition of the wound, UrgoTul, assessed by the investigator
55587|NCT02237118|O1|Outcome|Condition of the Wound Mepitel One|Condition of the wound assesed by the investigator
55588|NCT02237118|O2|Outcome|UrgoTul|Complete healing was reported for 27 subjects ( 49,1%) in theUrgoTul group.
55589|NCT02237118|O1|Outcome|Mepitel One|Complete healing was reported for 39 subjects ( 68,4%) in the Mepitel One group.
55590|NCT02237118|O2|Outcome|UrgoTul|"Non-Painful dressing removal, measured by VAS~Mepitel One~UrgoTul"
55591|NCT02237118|O1|Outcome|Mepitel One|"Non-Painful dressing removal, measured by VAS~Mepitel One~UrgoTul"
55592|NCT02237118|E2|Reported Event|UrgoTul|"Pain on removal by VAS~Mepitel One~UrgoTul"
55593|NCT02237118|E1|Reported Event|Mepitel One|"Pain on dressing removal, by VAS~Mepitel One~UrgoTul"
55594|NCT02237092|B1|Baseline|Measurement of IAP|Measurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, for 10 minutes, after quiet breathing pregnant at the time of expiration.The data obtained are in inches of water column were translated in millimeters of mercury.
55595|NCT02237092|P1|Participant Flow|Measurement of IAP|"The data obtained are in inches of water column were translated in millimeters of mercury.~Measurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, for 10 minutes, after quiet breathing pregnant at the time of expiration."
55596|NCT02237092|O2|Outcome|Level of IAP = > 16 mm Hg|number of pregnant women with Level of IAP = > 16 mm Hg
55597|NCT02237092|O1|Outcome|Level of IAP < 16 mm Hg|number of pregnant women with Level of IAP < 16 mm Hg
55598|NCT02237092|O2|Outcome|Level of Sensory Block < = Th5 (Spinal Anesthesia)|Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia
55599|NCT02237092|O1|Outcome|Level of Sensory Block => Th4 (Spinal Anesthesia)|Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia
55600|NCT02237092|O2|Outcome|Obesity|BMI = > 30.00
55601|NCT02237092|O1|Outcome|No Obesity|BMI < = 29.99
55602|NCT02237092|O2|Outcome|Level of Sensory Block < = Th5 (Spinal Anesthesia)|Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia
55603|NCT02237092|O1|Outcome|Level of Sensory Block => Th4 (Spinal Anesthesia)|Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia
55604|NCT02237092|O4|Outcome|Grade III|(21 - 25.99 mm Hg)
55605|NCT02237092|O3|Outcome|Grade II|(16 - 20.99 mm Hg)
55606|NCT02237092|O2|Outcome|Grade I|(12 - 15.99 mm Hg)
55607|NCT02237092|O1|Outcome|Physiological Norm|(≤11,99 mm Hg)
55608|NCT02237092|O1|Outcome|Intra-abdominal Pressure (IAP) in Pregnant Women|Average IAP in pregnant women
55609|NCT02237092|E2|Reported Event|Level of Sensory Block < = Th5 (Spinal Anesthesia)|Hypotension: Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure
55610|NCT02237092|E1|Reported Event|Level of Sensory Block => Th4 (Spinal Anesthesia)|Hypotension: Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure
55611|NCT02236767|B1|Baseline|TMS Therapy|"NeuroStar TMS Therapy System~Neurostar TMS Therapy System: Treatment will entail daily (5 days/week) sessions of rTMS for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC)."
55612|NCT02236767|P1|Participant Flow|TMS Therapy|"NeuroStar TMS Therapy System~Neurostar TMS Therapy System: Treatment will entail daily (5 days/week) sessions of rTMS for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC)."
55613|NCT02236767|O1|Outcome|rTMS Treatment|"NeuroStar TMS Therapy System~Neurostar TMS Therapy System: Treatment will entail daily (5 days/week) sessions of rTMS for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC)."
55695|NCT02235870|E2|Reported Event|Control Subjects|Control subjects include the 189 subjects in Phase I of the study who received at least 1 Sham Device and the 170 subjects in Phase II who were followed after balloon removal
55617|NCT02236611|B1|Baseline|UMEC 62.5 mcg QD|Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
55618|NCT02236611|P2|Participant Flow|GLYCO 44 mcg QD|Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
55619|NCT02236611|P1|Participant Flow|UMEC 62.5 mcg QD|Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
55620|NCT02236611|O2|Outcome|GLYCO 44 mcg QD|Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
55621|NCT02236611|O1|Outcome|UMEC 62.5 mcg QD|Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
55622|NCT02236611|E2|Reported Event|GLYCO 44 mcg QD|Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
55623|NCT02236611|E1|Reported Event|UMEC 62.5 mcg QD|Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
55624|NCT02236598|B3|Baseline|Total|Total of all reporting groups
55625|NCT02236598|B2|Baseline|Placebo|"Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months~Subjects will be instructed to take the pills~Placebo"
55626|NCT02236598|B1|Baseline|K+ Supplementation|"K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months~K+ supplement"
55627|NCT02236598|P2|Participant Flow|Placebo|"Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months~Subjects will be instructed to take the pills~Placebo"
55628|NCT02236598|P1|Participant Flow|K+ Supplementation|"K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months~K+ supplement"
55629|NCT02236598|O2|Outcome|Placebo|"Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months~Subjects will be instructed to take the pills~Placebo"
55630|NCT02236598|O1|Outcome|K+ Supplementation|"K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months~K+ supplement"
55631|NCT02236598|O2|Outcome|Placebo|"Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months~Subjects will be instructed to take the pills~Placebo"
55632|NCT02236598|O1|Outcome|K+ Supplementation|"K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months~K+ supplement"
55633|NCT02236598|O2|Outcome|Placebo|"Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months~Subjects will be instructed to take the pills~Placebo"
55634|NCT02236598|O1|Outcome|K+ Supplementation|"K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months~K+ supplement"
55635|NCT02236598|O2|Outcome|Placebo|"Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months~Subjects will be instructed to take the pills~Placebo"
55636|NCT02236598|O1|Outcome|K+ Supplementation|"K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months~K+ supplement"
55637|NCT02236598|E2|Reported Event|Placebo|"Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months~Subjects will be instructed to take the pills~Placebo"
55696|NCT02235870|E1|Reported Event|Treated Subjects|Treated subjects include the 198 subjects in Phase I of the study who received at least 1 Obalon Balloon and the 138 subjects in Phase II who crossover and received at least 1 Obalon Balloon
87181|NCT02040779|B4|Baseline|Total|Total of all reporting groups
55638|NCT02236598|E1|Reported Event|K+ Supplementation|"K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months~K+ supplement"
55639|NCT02236546|B1|Baseline|FDG-PET/CT|"Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.~[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.~Molecular assays on biopsied tissue: Correlative studies~positron emission tomography: Undergo FDG-PET/CT~computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images."
55640|NCT02236546|P1|Participant Flow|FDG-PET/CT|"Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.~[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.~Molecular assays on biopsied tissue: Correlative studies~positron emission tomography: Undergo FDG-PET/CT~computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images."
55641|NCT02236546|O1|Outcome|FDG-PET/CT|"Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.~[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.~Molecular assays on biopsied tissue: Correlative studies~positron emission tomography: Undergo FDG-PET/CT~computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images."
55642|NCT02236546|O1|Outcome|FDG-PET/CT|"Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.~[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.~Molecular assays on biopsied tissue: Correlative studies~positron emission tomography: Undergo FDG-PET/CT~computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images."
55643|NCT02236546|O1|Outcome|FDG-PET/CT|"Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.~[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.~Molecular assays on biopsied tissue: Correlative studies~positron emission tomography: Undergo FDG-PET/CT~computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images."
55644|NCT02236546|O1|Outcome|FDG-PET/CT|"Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.~[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.~Molecular assays on biopsied tissue: Correlative studies~positron emission tomography: Undergo FDG-PET/CT~computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images."
55645|NCT02236546|E1|Reported Event|FDG-PET/CT|"Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.~[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.~Molecular assays on biopsied tissue: Correlative studies~positron emission tomography: Undergo FDG-PET/CT~computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images."
55646|NCT02236338|B3|Baseline|Total|Total of all reporting groups
55647|NCT02236338|B2|Baseline|Laser Ablation|"Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).~Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.~Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.~EVLT 980nm diode laser system"
55697|NCT02235831|B1|Baseline|Overall|DACP MF, DACP MF (Low Add), and DACP (monovision) lenses worn in 6 different sequences as randomized in a crossover assignment.
55881|NCT02233998|E1|Reported Event|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
55648|NCT02236338|B1|Baseline|Radiofrequency Ablation|"Device: ClosureFAST radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).~Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.~Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.~ClosureFAST radiofrequency catheter"
55649|NCT02236338|P2|Participant Flow|Laser Ablation|"Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).~Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.~Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.~EVLT 980nm diode laser system"
55650|NCT02236338|P1|Participant Flow|Radiofrequency Ablation|"Device: ClosureFAST radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).~Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.~Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.~ClosureFAST radiofrequency catheter"
55651|NCT02236338|O2|Outcome|Laser Ablation|"Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).~Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.~Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.~EVLT 980nm diode laser system"
55652|NCT02236338|O1|Outcome|Radiofrequency Ablation|"Device: ClosureFAST radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).~Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.~Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.~ClosureFAST radiofrequency catheter"
55653|NCT02236338|O2|Outcome|Laser Ablation|"Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).~Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.~Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.~EVLT 980nm diode laser system"
55654|NCT02236338|O1|Outcome|Radiofrequency Ablation|"Device: ClosureFAST radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).~Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.~Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.~ClosureFAST radiofrequency catheter"
55655|NCT02236338|O2|Outcome|Laser Ablation|"Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).~Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.~Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.~EVLT 980nm diode laser system"
55656|NCT02236338|O1|Outcome|Radiofrequency Ablation|"Device: ClosureFAST radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).~Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.~Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.~ClosureFAST radiofrequency catheter"
55657|NCT02236338|O2|Outcome|Laser Ablation|"Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).~Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.~Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.~EVLT 980nm diode laser system"
55658|NCT02236338|O1|Outcome|Radiofrequency Ablation|"Device: ClosureFAST radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).~Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.~Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.~ClosureFAST radiofrequency catheter"
55882|NCT02233985|B3|Baseline|Total|Total of all reporting groups
55659|NCT02236338|E2|Reported Event|Laser Ablation|"Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).~Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.~Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.~EVLT 980nm diode laser system"
55660|NCT02236338|E1|Reported Event|Radiofrequency Ablation|"Device: ClosureFAST radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).~Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.~Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.~ClosureFAST radiofrequency catheter"
55661|NCT02236130|B3|Baseline|Total|Total of all reporting groups
55662|NCT02236130|B2|Baseline|Regional|"General Anesthesia combined with regional block~Regional block: Single shot peripheral nerve block~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Local Anesthetic Ropivacaine: 0.5% Ropivacaine~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
55663|NCT02236130|B1|Baseline|General|"General Anesthesia only~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
55664|NCT02236130|P2|Participant Flow|Regional|"General Anesthesia combined with regional block~Regional block: Single shot peripheral nerve block~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Local Anesthetic Ropivacaine: 0.5% Ropivacaine~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
55665|NCT02236130|P1|Participant Flow|General|"General Anesthesia only~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
55666|NCT02236130|O2|Outcome|Regional|"General Anesthesia combined with regional block~Regional block: Single shot peripheral nerve block~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Local Anesthetic Ropivacaine: 0.5% Ropivacaine~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
55667|NCT02236130|O1|Outcome|General|"General Anesthesia only~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
55668|NCT02236130|O2|Outcome|Regional|"General Anesthesia combined with regional block~Regional block: Single shot peripheral nerve block~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Local Anesthetic Ropivacaine: 0.5% Ropivacaine~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
55669|NCT02236130|O1|Outcome|General|"General Anesthesia only~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
55670|NCT02236130|E2|Reported Event|Regional|"General Anesthesia combined with regional block~Regional block: Single shot peripheral nerve block~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Local Anesthetic Ropivacaine: 0.5% Ropivacaine~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
55671|NCT02236130|E1|Reported Event|General|"General Anesthesia only~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
55672|NCT02235987|B1|Baseline|Cross-over|Interventions: octreotide and DG3173. Eligible patients are to receive 300 µg octreotide as active comparator, followed by four ascending doses of 100 µg, 300 µg, 900 µg and 1800 µg DG3173. All treatments will be administered consecutively to all patients as single subcutaneous bolus injections.
55673|NCT02235987|P1|Participant Flow|Octreotide, Then Ascending DG3173|Interventions: octreotide and DG3173. Eligible patients are to receive 300 µg octreotide as active comparator, followed by four ascending doses of 100 µg, 300 µg, 900 µg and 1800 µg DG3173. All treatments will be administered consecutively to all patients as single subcutaneous bolus injections.
55674|NCT02235987|O6|Outcome|1800 µg DG3173|
55675|NCT02235987|O5|Outcome|900 µg DG3173|
55676|NCT02235987|O4|Outcome|300 µg DG3173|
55677|NCT02235987|O3|Outcome|100 µg DG3173|
55678|NCT02235987|O2|Outcome|300 µg Octreotide|
55679|NCT02235987|O1|Outcome|Baseline (Untreated Control)|
55680|NCT02235987|E5|Reported Event|1800 µg DG3173|
55681|NCT02235987|E4|Reported Event|900 µg DG3173|
55682|NCT02235987|E3|Reported Event|300 µg DG3173|
55683|NCT02235987|E2|Reported Event|100 µg DG3173|
55684|NCT02235987|E1|Reported Event|300 µg Octreotide|
55685|NCT02235870|B3|Baseline|Total|Total of all reporting groups
55686|NCT02235870|B2|Baseline|Sham Control Group|Sham Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
55687|NCT02235870|B1|Baseline|Obalon Treatment Group|Obalon Balloon Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
55688|NCT02235870|P2|Participant Flow|Sham Control Group|Sham Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
55689|NCT02235870|P1|Participant Flow|Obalon Treatment Group|Obalon Balloon Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
55690|NCT02235870|O2|Outcome|Sham Control Group|Sham Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
55691|NCT02235870|O1|Outcome|Obalon Treatment Group|Obalon Balloon Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
55692|NCT02235870|O1|Outcome|Obalon Treatment Group|Subjects who received the Obalon Balloons.
55693|NCT02235870|O2|Outcome|Sham Control Group|Sham Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
55694|NCT02235870|O1|Outcome|Obalon Treatment Group|Obalon Balloon Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
55698|NCT02235831|P6|Participant Flow|Seq 6|DACP (monovision) lenses first, followed by DACP MF (Low Add) lenses next, and DACP MF lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
55699|NCT02235831|P5|Participant Flow|Seq 5|DACP (monovision) lenses first, followed by DACP MF lenses next, and DACP MF (Low Add) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
55700|NCT02235831|P4|Participant Flow|Seq 4|DACP MF (Low Add) lenses worn first, followed by DACP (monovision) lenses next, and DACP MF last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
55701|NCT02235831|P3|Participant Flow|Seq 3|DACP MF (Low Add) lenses worn first, followed by DACP MF lenses next, and DACP (monovision) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
55702|NCT02235831|P2|Participant Flow|Seq 2|DACP MF lenses worn first, followed by DACP (monovision) lenses next, and DACP MF (Low Add) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
55703|NCT02235831|P1|Participant Flow|Seq I|DACP MF lenses worn first, followed by DACP MF (Low Add) lenses next, and DACP (monovision) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
55704|NCT02235831|O2|Outcome|DACP MF|Nelfilcon A multifocal contact lenses worn during Period 1, 2, or 3 for 5±1 days.
55705|NCT02235831|O1|Outcome|Monovision|Nelfilcon A contact lenses worn as monovision during Period 1, 2, or 3 for 5±1 days.
55706|NCT02235831|E3|Reported Event|DACP MF (Low Add)|Nelfilcon A multifocal contact lenses worn during Period 1, 2, or 3 for 5±1 days.
55707|NCT02235831|E2|Reported Event|DACP MF|Nelfilcon A multifocal contact lenses worn during Period 1, 2, or 3 for 5±1 days.
55708|NCT02235831|E1|Reported Event|Monovision|Nelfilcon A contact lenses worn as monovision during Period 1, 2, or 3 for 5±1 days.
55709|NCT02235493|B1|Baseline|Retrospective Observational|Patients diagnosed with juvenile-onset hypophosphatasia (HPP) [ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age].
55710|NCT02235493|P1|Participant Flow|Retrospective Observational|Patients diagnosed with juvenile-onset hypophosphatasia (HPP) [ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age].
55711|NCT02235493|O1|Outcome|Retrospective Observational|Patients diagnosed with juvenile-onset hypophosphatasia (HPP) [ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age].
55712|NCT02235493|O1|Outcome|Retrospective Observational|Patients diagnosed with juvenile-onset hypophosphatasia (HPP) [ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age].
55713|NCT02235493|E1|Reported Event|Retrospective Observational|Patients diagnosed with juvenile-onset hypophosphatasia (HPP) [ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age].
55714|NCT02235454|B1|Baseline|Glaucoma Arm|"Consecutive patients with glaucoma will undergo non-invasive OCT imaging~SDOCT-GMPE software: Noninvasive imaging of the optic nerve in patients with existing glaucoma"
55715|NCT02235454|P1|Participant Flow|Glaucoma Arm|"Consecutive patients with glaucoma will undergo non-invasive OCT imaging~SDOCT-GMPE software: Noninvasive imaging of the optic nerve in patients with existing glaucoma"
55716|NCT02235454|O1|Outcome|Glaucoma Arm|"Consecutive patients with glaucoma will undergo non-invasive OCT imaging~SDOCT-GMPE software: Noninvasive imaging of the optic nerve in patients with existing glaucoma"
55717|NCT02235454|E1|Reported Event|Glaucoma Arm|"Consecutive willing patients with glaucoma will undergo non-invasive OCT imaging~SDOCT-GMPE software: Noninvasive imaging of the optic nerve in patients with existing glaucoma"
55718|NCT02235311|B3|Baseline|Total|Total of all reporting groups
55719|NCT02235311|B2|Baseline|Pantoprazole Once Daily|"Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB~Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
55720|NCT02235311|B1|Baseline|Pantoprazole Twice Daily|"Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB~Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
55721|NCT02235311|P2|Participant Flow|Pantoprazole Once Daily|"Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB~Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
55722|NCT02235311|P1|Participant Flow|Pantoprazole Twice Daily|"Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB~Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
55723|NCT02235311|O2|Outcome|Pantoprazole Once Daily|"Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB~Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
55724|NCT02235311|O1|Outcome|Pantoprazole Twice Daily|"Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB~Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
55725|NCT02235311|O2|Outcome|Pantoprazole Once Daily|"Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB~Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
55726|NCT02235311|O1|Outcome|Pantoprazole Twice Daily|"Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB~Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
55727|NCT02235311|O2|Outcome|Pantoprazole Once Daily|"Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB~Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
55728|NCT02235311|O1|Outcome|Pantoprazole Twice Daily|"Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB~Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
55729|NCT02235311|O2|Outcome|Pantoprazole Once Daily|"Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB~Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
55730|NCT02235311|O1|Outcome|Pantoprazole Twice Daily|"Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB~Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
55731|NCT02235311|E2|Reported Event|Pantoprazole Once Daily|"Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB~Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
56313|NCT02230670|O1|Outcome|IDN-6556|"25 mg BID of IDN-6556~IDN-6556: 25 mg BID"
56314|NCT02230670|O2|Outcome|Placebo|"Placebo BID~Placebo"
55732|NCT02235311|E1|Reported Event|Pantoprazole Twice Daily|"Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB~Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
55733|NCT02235285|B1|Baseline|All Study Participants|Participants were 162-consecutive patients underwent primary breast augmentation by one surgeon.
55734|NCT02235285|P1|Participant Flow|Breast Augmentation,Reoperation|The most common cause of reoperation in breast augmentation is a capsular contracture. So the prevention of capsular contracture is very important in breast augmentation. The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon. The rate of follow-up at 5 years for all patients was 92 percent.
55735|NCT02235285|O1|Outcome|Breast Augmentation, Reoperation|The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.
55736|NCT02235285|E1|Reported Event|Breast Augmentation, Reoperation|The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.
55737|NCT02235077|B3|Baseline|Total|Total of all reporting groups
55738|NCT02235077|B2|Baseline|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55739|NCT02235077|B1|Baseline|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55740|NCT02235077|P2|Participant Flow|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55741|NCT02235077|P1|Participant Flow|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55742|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55743|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55744|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55745|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55746|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55747|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55748|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55749|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55750|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55769|NCT02235064|P2|Participant Flow|Placebo|"Identical appearing capsule daily containing color-matched cellulose only~Placebo: Capsule containing cellulose powder of same color as experimental arm"
56315|NCT02230670|O1|Outcome|IDN-6556|"25 mg BID of IDN-6556~IDN-6556: 25 mg BID"
55751|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55752|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55753|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55754|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55755|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55756|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55757|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55758|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55759|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55760|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55761|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55762|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55763|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55764|NCT02235077|E2|Reported Event|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55765|NCT02235077|E1|Reported Event|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
55766|NCT02235064|B3|Baseline|Total|Total of all reporting groups
55767|NCT02235064|B2|Baseline|Placebo|"Identical appearing capsule daily containing color-matched cellulose only~Placebo: Capsule containing cellulose powder of same color as experimental arm"
55768|NCT02235064|B1|Baseline|Sertraline|"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper~Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper"
55877|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
55770|NCT02235064|P1|Participant Flow|Sertraline|"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper~Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper"
55771|NCT02235064|O2|Outcome|Placebo|Identical appearing capsule daily containing color-matched cellulose only
55772|NCT02235064|O1|Outcome|Sertraline|Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
55773|NCT02235064|O2|Outcome|Placebo|Identical appearing capsule daily containing color-matched cellulose only
55774|NCT02235064|O1|Outcome|Sertraline|Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
55775|NCT02235064|O2|Outcome|Placebo|Identical appearing capsule daily containing color-matched cellulose only
55776|NCT02235064|O1|Outcome|Sertraline|Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
55777|NCT02235064|O2|Outcome|Placebo|Identical appearing capsule daily containing color-matched cellulose only
55778|NCT02235064|O1|Outcome|Sertraline|Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
55779|NCT02235064|O2|Outcome|Placebo|Identical appearing capsule daily containing color-matched cellulose only
55780|NCT02235064|O1|Outcome|Sertraline|Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
55781|NCT02235064|O2|Outcome|Placebo|Identical appearing capsule daily containing color-matched cellulose only
55782|NCT02235064|O1|Outcome|Sertraline|Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
55783|NCT02235064|O2|Outcome|Placebo|Identical appearing capsule daily containing color-matched cellulose only
55784|NCT02235064|O1|Outcome|Sertraline|Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
55785|NCT02235064|O2|Outcome|Placebo|Identical appearing capsule daily containing color-matched cellulose only
55786|NCT02235064|O1|Outcome|Sertraline|Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
55787|NCT02235064|O2|Outcome|Placebo|Identical appearing capsule daily containing color-matched cellulose only
55788|NCT02235064|O1|Outcome|Sertraline|Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
55789|NCT02235064|O2|Outcome|Placebo|Identical appearing capsule daily containing color-matched cellulose only
55790|NCT02235064|O1|Outcome|Sertraline|Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
55791|NCT02235064|O2|Outcome|Placebo|"Identical appearing capsule daily containing color-matched cellulose only~Placebo: Capsule containing cellulose powder of same color as experimental arm"
55792|NCT02235064|O1|Outcome|Sertraline|"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper~Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper"
55793|NCT02235064|E2|Reported Event|Placebo|"Identical appearing capsule daily containing color-matched cellulose only~Placebo: Capsule containing cellulose powder of same color as experimental arm"
55794|NCT02235064|E1|Reported Event|Sertraline|"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper~Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper"
55795|NCT02234752|B1|Baseline|Galantamine ER, Memantine XR|"Week 1, Galantamine ER 8 mg HS & Memantine XR 7 mg HS Week 2, Galantamine ER 16 mg HS & Memantine XR 14 mg HS Weeks 3-6, Galantamine ER 24 mg HS & Memantine XR 21 mg HS~Galantamine ER~Memantine XR"
55796|NCT02234752|P1|Participant Flow|Galantamine ER, Memantine XR|"Week 1, Galantamine ER 8 mg HS & Memantine XR 7 mg HS Week 2, Galantamine ER 16 mg HS & Memantine XR 14 mg HS Weeks 3-6, Galantamine ER 24 mg HS & Memantine XR 21 mg HS~Galantamine ER~Memantine XR"
55797|NCT02234752|O1|Outcome|KP Metabolites Values|
55798|NCT02234752|O1|Outcome|KP Metabolites Values|
55799|NCT02234752|O1|Outcome|KP Metabolites Values|
55800|NCT02234752|O1|Outcome|KP Metabolites Values|
55801|NCT02234752|O1|Outcome|KP Metabolites Values|
55802|NCT02234752|O1|Outcome|KP Metabolites Values|
55803|NCT02234752|O1|Outcome|KP Metabolites Values|
55804|NCT02234752|O1|Outcome|Galantamine ER, Memantine XR|"Week 1, Galantamine ER 8 mg HS & Memantine XR 7 mg HS Week 2, Galantamine ER 16 mg HS & Memantine XR 14 mg HS Weeks 3-6, Galantamine ER 24 mg HS & Memantine XR 21 mg HS~Galantamine ER~Memantine XR"
55805|NCT02234752|E1|Reported Event|Galantamine ER, Memantine XR|"Week 1, Galantamine ER 8 mg HS & Memantine XR 7 mg HS Week 2, Galantamine ER 16 mg HS & Memantine XR 14 mg HS Weeks 3-6, Galantamine ER 24 mg HS & Memantine XR 21 mg HS~Galantamine ER~Memantine XR"
55806|NCT02234479|B3|Baseline|Total|Total of all reporting groups
55807|NCT02234479|B2|Baseline|MediHoney (Group B)|"Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~MediHoney (Group B): It helps the body’s natural healing processes in three key ways which have been shown to have healing benefits:~Maintain a balanced environment for healing.~Aids in reducing dermatitis.~Reduce affected area pH.2-3"
55878|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
88841|NCT02033499|O1|Outcome|No Testing|No SMBG testing
55808|NCT02234479|B1|Baseline|Hydrophor (Group A)|"Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin~•May be used alone as a skin lubricant or protectant"
55809|NCT02234479|P2|Participant Flow|MediHoney (Group B)|"Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~MediHoney (Group B): It helps the body’s natural healing processes in three key ways which have been shown to have healing benefits:~Maintain a balanced environment for healing.~Aids in reducing dermatitis.~Reduce affected area pH.2-3"
55810|NCT02234479|P1|Participant Flow|Hydrophor (Group A)|"Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin~•May be used alone as a skin lubricant or protectant"
55811|NCT02234479|O2|Outcome|MediHoney (Group B)|"Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~MediHoney (Group B): It helps the body’s natural healing processes in three key ways which have been shown to have healing benefits:~Maintain a balanced environment for healing.~Aids in reducing dermatitis.~Reduce affected area pH.2-3"
55812|NCT02234479|O1|Outcome|Hydrophor (Group A)|"Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin~•May be used alone as a skin lubricant or protectant"
55813|NCT02234479|E2|Reported Event|MediHoney (Group B)|"Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~MediHoney (Group B): It helps the body’s natural healing processes in three key ways which have been shown to have healing benefits:~Maintain a balanced environment for healing.~Aids in reducing dermatitis.~Reduce affected area pH.2-3"
55814|NCT02234479|E1|Reported Event|Hydrophor (Group A)|"Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin~•May be used alone as a skin lubricant or protectant"
55815|NCT02234427|B1|Baseline|Aspirin|Aspirin: 2-week aspirin therapy (81mg/day)
55816|NCT02234427|P1|Participant Flow|Aspirin|Aspirin: 2-week aspirin therapy (81mg/day)
55817|NCT02234427|O1|Outcome|Aspirin|Aspirin: 2-week aspirin therapy (81mg/day)
55818|NCT02234427|E1|Reported Event|Aspirin|Aspirin: 2-week aspirin therapy (81mg/day)
55819|NCT02234362|B1|Baseline|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
55879|NCT02233998|E3|Reported Event|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
94253|NCT02005211|O7|Outcome|Placebo Part2|Placebo Part 2 - MAD
55820|NCT02234362|P1|Participant Flow|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
55821|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
55822|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
55823|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
55824|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
55825|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
55826|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
55827|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
55828|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
55829|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
55830|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
55831|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
55832|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
55833|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
55834|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
55835|NCT02234362|E1|Reported Event|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
55880|NCT02233998|E2|Reported Event|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
94254|NCT02005211|O6|Outcome|Placebo Part 1|Placebo Part 1 - SAD
55836|NCT02234115|B1|Baseline|Leuprolide Mesylate 50mg|"All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336.~Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate"
55837|NCT02234115|P1|Participant Flow|Leuprolide Mesylate 50mg|"All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336.~Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate"
55838|NCT02234115|O1|Outcome|Leuprolide Mesylate 50mg|"All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336.~Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate"
55839|NCT02234115|O1|Outcome|Leuprolide Mesylate 50mg|"All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336.~Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate"
55840|NCT02234115|E1|Reported Event|Leuprolide Mesylate 50mg|"All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336.~Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate"
55841|NCT02234011|B1|Baseline|Treatment|No participants enrolled in treatment portion of study, and therefore never completed a baseline visit. One subject completed a screening visit and then withdrew from study due to time commitments.
55842|NCT02234011|P1|Participant Flow|Treatment|No participants enrolled in treatment portion of study.
55843|NCT02234011|O1|Outcome|Treatment|No participants enrolled in treatment portion of study.
55844|NCT02234011|E1|Reported Event|Treatment|"No participants enrolled in treatment portion of study. One subject had a screening visit, but since she never entered the treatment portion of the study and never received the study medication. Because she never had any exposure to the study medication and had no visits other than the initial screening visit, she was never at risk for any adverse events related to study medication.~No adverse events related to study medication were collected since no subjects ever entered the treatment phase of this study."
55845|NCT02233998|B4|Baseline|Total|Total of all reporting groups
55846|NCT02233998|B3|Baseline|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
55847|NCT02233998|B2|Baseline|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
55848|NCT02233998|B1|Baseline|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
55849|NCT02233998|P3|Participant Flow|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
55850|NCT02233998|P2|Participant Flow|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
55851|NCT02233998|P1|Participant Flow|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
55852|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
55853|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
55854|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
55855|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
55856|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
55857|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
55858|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
55859|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
55860|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
55861|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
55862|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
55863|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
55864|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
55865|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
55866|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
55867|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
55868|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
55869|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
55870|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
55871|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
55872|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
55873|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
55874|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
55875|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
55876|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
56316|NCT02230670|E2|Reported Event|Placebo (Baseline-Month 3)|Placebo BID (Baseline-Month 3)
55883|NCT02233985|B2|Baseline|Nebulized 3% Sodium Chloride|"Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.~3% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay."
55884|NCT02233985|B1|Baseline|Nebulized 0.9% Sodium Chloride|"Salbutamol 100 micrograms / kg / dose administered 0.9 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.~0.9% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 0.9% saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay."
55885|NCT02233985|P2|Participant Flow|Nebulized 3% Sodium Chloride|"Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.~3% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay."
55886|NCT02233985|P1|Participant Flow|Nebulized 0.9% Sodium Chloride|"Salbutamol 100 micrograms / kg / dose administered 0.9 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.~0.9% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 0.9% saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay."
55887|NCT02233985|O2|Outcome|Saline Solution 0.9% (SS 0.9%) Group|We counted the hours from admission of the patient to the pediatric emergency department until hospital discharge. Staying hospitalized until they had mild respiratory stage scale scores for at least 2 hrs.
55888|NCT02233985|O1|Outcome|Hypertonic Saline Solution 3% (SHS 3%)|We counted the hours from admission of the patient to the pediatric emergency department until hospital discharge. Staying hospitalized until they had mild respiratory stage scale scores for at least 2 hrs.
55889|NCT02233985|O2|Outcome|Saline Solution 0.9% (SS 0.9%) Group|Patients with moderate stages (6 to 10 points) and severe (11 to 16 points) were selected, performing subsequent measurements always 30 minutes after nebulization corresponding.
55890|NCT02233985|O1|Outcome|Hypertonic Saline Solution 3% (HSS 3%) Group|Patients with moderate stages (6 to 10 points) and severe (11 to 16 points) were selected, performing subsequent measurements always 30 minutes after nebulization corresponding.
55891|NCT02233985|E2|Reported Event|Nebulized 3% Sodium Chloride|"Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.~3% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay."
55892|NCT02233985|E1|Reported Event|Nebulized 0.9% Sodium Chloride|"Salbutamol 100 micrograms / kg / dose administered 0.9 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.~0.9% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 0.9% saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay."
55893|NCT02233842|B1|Baseline|All Participants|"Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.~Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products"
55894|NCT02233842|P1|Participant Flow|Tobacco Use in Cancer Patients and Survivors|"Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.~Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.~Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting."
55895|NCT02233842|O1|Outcome|All Participants|"Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.~Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.~Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting."
55896|NCT02233842|O1|Outcome|All Participants|"Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.~Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.~Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting."
55897|NCT02233842|O1|Outcome|All Participants|"Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.~Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.~Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting."
55898|NCT02233842|O1|Outcome|All Participants|"People who have cancer and who have survived cancer~Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products."
55899|NCT02233842|E1|Reported Event|Tobacco Use in Cancer Patients and Survivors|"People who have cancer and who have survived cancer~Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products."
55900|NCT02233803|B1|Baseline|Total|The eligible participants were randomised to receive either Regimen A in TP1 and Regimen B in TP2, or Regimen B in TP1 and Regimen A in TP2 according to the randomisation schedule. Both the TPs were separated by a wash out period of 4 weeks. Regimen A: 1 inhalation of budesonide/formoterol fumarate (BFF), 400/12 microgram [mcg] (NEUMOTEROL 400) by single capsule inhaler each morning and evening. Regimen B: 1 inhalation of BFF 320/9 mcg (SYMBICORT FORTE) by turbuhaler inhaler each morning and evening. Additionally all participants were allowed to take rescue medication (salbutamol 100 mcg) during the study.
55967|NCT02233101|P1|Participant Flow|Oral Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Oral Tranexamic Acid: patients will receive 1950mg of oral prior to surgery to help reduce blood loss during total joint replacement"
56317|NCT02230670|E1|Reported Event|IDN-6556 (Baseline-Month 3)|25 mg BID of IDN-6556 (Baseline-Month 3).
55901|NCT02233803|P2|Participant Flow|SYMBICORT FORTE/ NEUMOTEROL 400|During TP1, the participants received Regimen B where the eligible participants took, 1 inhalation of BFF 320/9 mcg (SYMBICORT FORTE), by turbuhaler inhaler each morning and evening for 4-Wks. This was followed by a wash out period of 4 Wks, during which all the participants received budesonide DPI 400 mcg (NEUMOTEX 400) twice daily. It was then followed by Regimen A during which eligible participants received, 1 inhalation of NEUMOTEROL 400 by single capsule inhaler each morning and evening, for 4-Wks. Additionally all participants were allowed to take rescue medication (salbutamol 100 mcg) during the study.
55902|NCT02233803|P1|Participant Flow|NEUMOTEROL 400/ SYMBICORT FORTE|During TP1, participants received Regimen A where the eligible participants received, 1 inhalation of budesonide/formoterol fumarate (BFF), 400/12 microgram [mcg] (NEUMOTEROL 400) by single capsule inhaler each morning and evening for 4- weeks (Wks). This was followed by a wash out period of 4 Wks , during which all the participants received budesonide DPI 400 mcg (NEUMOTEX 400) twice daily. The wash-out period was followed by Regimen B during which the eligible participants took, 1 inhalation of BFF 320/9 mcg (SYMBICORT FORTE), by turbuhaler inhaler each morning and evening, for 4-Wks. Additionally all participants were allowed to take rescue medication (salbutamol 100 mcg) during the study.
55903|NCT02233803|O2|Outcome|SYMBICORT FORTE|Eligible participants received Symbicort forte during TP1 or TP2 as per their randomization. The TPs were separated by washout period of 4-wks during which participants received NEUMOTEX 400, twice daily. The participants were allowed to take salbutamol 100mcg pMDI, as rescue medication.
55904|NCT02233803|O1|Outcome|NEUMOTEROL 400|Eligible participants received NEUMOTEROL 400 during TP1 or TP2 as per their randomization. The TPs were separated by washout period of 4-wks during which participants received NEUMOTEX 400, twice daily. The participants were allowed to take salbutamol 100mcg pMDI, as rescue medication.
55905|NCT02233803|O2|Outcome|SYMBICORT FORTE|Eligible participants received Symbicort forte during TP1 or TP2 as per their randomization. The TPs were separated by washout period of 4-wks during which participants received NEUMOTEX 400, twice daily. The participants were allowed to take salbutamol 100mcg pMDI, as rescue medication.
55906|NCT02233803|O1|Outcome|NEUMOTEROL 400|Eligible participants received NEUMOTEROL 400 during TP1 or TP2 as per their randomization. The TPs were separated by washout period of 4-wks during which participants received NEUMOTEX 400, twice daily. The participants were allowed to take salbutamol 100mcg pMDI, as rescue medication.
55907|NCT02233803|O2|Outcome|SYMBICORT FORTE|Eligible participants received Symbicort forte during TP1 or TP2 as per their randomization . The TPs were separated by washout period of 4-wks during which participants received NEUMOTEX 400, twice daily. The participants were allowed to take salbutamol 100mcg pMDI, as rescue medication.
55908|NCT02233803|O1|Outcome|NEUMOTEROL 400|Eligible participants received NEUMOTEROL 400 during TP1 or TP2 as per their randomization. The TPs were separated by washout period of 4-wks during which participants received NEUMOTEX 400, twice daily. The participants were allowed to take salbutamol 100mcg pressurized metered dose inhaler (pMDI), as rescue medication.
55909|NCT02233803|E2|Reported Event|SYMBICORT FORTE|Eligible participants received Symbicort forte during TP1 or TP2 as per their randomization. The TPs were separated by washout period of 4-wks during which participants received NEUMOTEX 400, twice daily. The participants were allowed to take salbutamol 100mcg pMDI, as rescue medication.
55910|NCT02233803|E1|Reported Event|NEUMOTEROL 400|Eligible participants received NEUMOTEROL 400 during TP1 or TP2 as per their randomization. The TPs were separated by washout period of 4-wks during which participants received NEUMOTEX 400, twice daily. The participants were allowed to take salbutamol 100mcg pMDI, as rescue medication.
55911|NCT02233647|B1|Baseline|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
55912|NCT02233647|P1|Participant Flow|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Intranasal cocaine (10, 20, 40 and 80 mg) was administered acutely after at least seven days of maintenance on each condition.~Intransasal placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo were determined during maintenance on placebo and phendimetrazine."
55913|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
55914|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
55915|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
56032|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
55916|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
55917|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
55918|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
55919|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
55920|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
55921|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
55922|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
55923|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
55924|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
55925|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
55926|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
55927|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
55928|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
55929|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
55930|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
55931|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
55932|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
55933|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
55934|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
55935|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
55936|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
55937|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
55938|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
55939|NCT02233647|E1|Reported Event|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Intranasal cocaine (10, 20, 40 and 80 mg) was administered acutely after at least seven days of maintenance on each condition.~Intransasal placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo were determined during maintenance on placebo and phendimetrazine."
55940|NCT02233309|B1|Baseline|Monitoring of Pressures During Caudal Anesthesia|"Patients receiving caudal anesthesia as standard of care for a surgical procedure.~Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.~Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol."
55941|NCT02233309|P1|Participant Flow|Monitoring of Pressures During Caudal Anesthesia|"Patients receiving caudal anesthesia as standard of care for a surgical procedure.~Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.~Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol."
55942|NCT02233309|O1|Outcome|Monitoring of Pressures During Caudal Anesthesia|"Patients receiving caudal anesthesia as standard of care for a surgical procedure.~Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.~Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol."
55943|NCT02233309|E1|Reported Event|Monitoring of Pressures During Caudal Anesthesia|"Patients receiving caudal anesthesia as standard of care for a surgical procedure.~Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.~Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol."
55944|NCT02233296|B3|Baseline|Total|Total of all reporting groups
55945|NCT02233296|B2|Baseline|Group B|"Dosing Sequence: Administration of lasmiditan 200 mg in fasted state in Dosing Period 1 followed by administration in lasmiditan 200 mg fed state in Dosing Period 2.~Lasmiditan: 2 discrete doses separated by 6 days."
55946|NCT02233296|B1|Baseline|Group A|"Dosing Sequence: Administration of lasmiditan 200 mg in fed state in Dosing Period 1 followed by administration of lasmiditan 200 mg in fasted state in Dosing Period 2~Lasmiditan: 2 discrete doses separated by 6 days."
55947|NCT02233296|P2|Participant Flow|Group B|"Dosing Sequence: Administration of lasmiditan 200 mg in fasted state in Dosing Period 1 followed by administration in lasmiditan 200 mg fed state in Dosing Period 2.~Lasmiditan: 2 discrete doses separated by 6 days."
55948|NCT02233296|P1|Participant Flow|Group A|"Dosing Sequence: Administration of lasmiditan 200 mg in fed state in Dosing Period 1 followed by administration of lasmiditan 200 mg in fasted state in Dosing Period 2~Lasmiditan: 2 discrete doses separated by 6 days."
55949|NCT02233296|O2|Outcome|Fasted Condition|Participants were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
55950|NCT02233296|O1|Outcome|Fed Condition|Participants were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
55951|NCT02233296|O2|Outcome|Fasted Condition|Participants were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
55952|NCT02233296|O1|Outcome|Fed Condition|Participants were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
55953|NCT02233296|O2|Outcome|Fasted Condition (n=30)|Data presented is all participants in the fasted condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed).
55954|NCT02233296|O1|Outcome|Fed Condition (n=30)|Data presented is all participants in the fed condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed).
55955|NCT02233296|O2|Outcome|Fasted Condition|Data presented is all participants in the fasted condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed).
55956|NCT02233296|O1|Outcome|Fed Condition|Data presented is all participants in the fed condition not by sequence of assigned cross-over (fed/fasted or fasted/fed).
55957|NCT02233296|O2|Outcome|Fasted Condition|Participants were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
55958|NCT02233296|O1|Outcome|Fed Condition|Participants were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
55959|NCT02233296|O2|Outcome|Fasted Condition|Participants were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
55960|NCT02233296|O1|Outcome|Fed Condition|Participants were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
55961|NCT02233296|E2|Reported Event|Fasted Condition (n=30)|Participants were randomized to fed/fasted or fasted/fed. Conditions were pooled for analysis so regardless of sequence all AEs reported while participant was in fasted condition are considered equally.
55962|NCT02233296|E1|Reported Event|Fed Condition (n=30)|Participants were randomized to fed/fasted or fasted/fed. Conditions were pooled for analysis so regardless of sequence all AEs reported while participant was in fed condition are considered equally.
55963|NCT02233101|B3|Baseline|Total|Total of all reporting groups
55964|NCT02233101|B2|Baseline|Intravenous Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Intravenous Tranexamic Acid: Patients will receive 1950mg of intravenous Tranexamic Acid prior to total joint arthroplasty and blood loss or need for transfusion within 24 hours post operative"
55965|NCT02233101|B1|Baseline|Oral Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Oral Tranexamic Acid: patients will receive 1950mg of oral prior to surgery to help reduce blood loss during total joint replacement"
55966|NCT02233101|P2|Participant Flow|Intravenous Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Intravenous Tranexamic Acid: Patients will receive 1950mg of intravenous Tranexamic Acid prior to total joint arthroplasty and blood loss or need for transfusion within 24 hours post operative"
55968|NCT02233101|O2|Outcome|Intravenous Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Intravenous Tranexamic Acid: Patients will receive 1950mg of intravenous Tranexamic Acid prior to total joint arthroplasty and blood loss or need for transfusion within 24 hours post operative"
55969|NCT02233101|O1|Outcome|Oral Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Oral Tranexamic Acid: patients will receive 1950mg of oral prior to surgery to help reduce blood loss during total joint replacement"
55970|NCT02233101|O2|Outcome|Intravenous Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Intravenous Tranexamic Acid: Patients will receive 1950mg of intravenous Tranexamic Acid prior to total joint arthroplasty and blood loss or need for transfusion within 24 hours post operative"
55971|NCT02233101|O1|Outcome|Oral Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Oral Tranexamic Acid: patients will receive 1950mg of oral prior to surgery to help reduce blood loss during total joint replacement"
55972|NCT02233101|E2|Reported Event|Intravenous Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Intravenous Tranexamic Acid: Patients will receive 1950mg of intravenous Tranexamic Acid prior to total joint arthroplasty and blood loss or need for transfusion within 24 hours post operative"
55973|NCT02233101|E1|Reported Event|Oral Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Oral Tranexamic Acid: patients will receive 1950mg of oral prior to surgery to help reduce blood loss during total joint replacement"
55974|NCT02232880|B1|Baseline|Consented Patients|No patients received treatment prior to study termination
55975|NCT02232880|P1|Participant Flow|Consented Patients|
55976|NCT02232880|O1|Outcome|Consented Patients|
55977|NCT02232880|O1|Outcome|Consented Patients|
55978|NCT02232880|O1|Outcome|Consented Patients|
55979|NCT02232880|O1|Outcome|Consented Patients|
55980|NCT02232880|E1|Reported Event|Consented Patients|No patients received treatment prior to study termination
55981|NCT02232698|B3|Baseline|Total|Total of all reporting groups
55982|NCT02232698|B2|Baseline|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
55983|NCT02232698|B1|Baseline|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
55984|NCT02232698|P2|Participant Flow|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
55985|NCT02232698|P1|Participant Flow|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
55986|NCT02232698|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
55987|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
55988|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
55989|NCT02232698|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
56318|NCT02230566|B5|Baseline|Total|Total of all reporting groups
55990|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
55991|NCT02232698|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
55992|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
55993|NCT02232698|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
55994|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
55995|NCT02232698|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
55996|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
55997|NCT02232698|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
55998|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
55999|NCT02232698|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
56000|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
56001|NCT02232698|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
94379|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
56002|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
56003|NCT02232698|E2|Reported Event|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
56004|NCT02232698|E1|Reported Event|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
56005|NCT02232126|B3|Baseline|Total|Total of all reporting groups
56006|NCT02232126|B2|Baseline|Intervention|SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
56007|NCT02232126|B1|Baseline|Usual Care|Usual care consisted of the usual course of care provided to older adults transitioning home from a hospital stay at Huntington Memorial Hospital
56008|NCT02232126|P2|Participant Flow|Intervention|SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
56009|NCT02232126|P1|Participant Flow|Usual Care|
56010|NCT02232126|O2|Outcome|Intervention Group: Opt-outs|Patients randomized to the intervention group that refused the intervention.
56011|NCT02232126|O1|Outcome|Intervention Group: Received Intervention|Patients randomized to the intervention group and received the intervention. SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
56012|NCT02232126|O2|Outcome|Intervention|SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
56013|NCT02232126|O1|Outcome|Usual Care|Usual Care in the present study constitutes usual care that is delivered to older adults transitioning from the hospital to home from Huntington Memorial Hospital.
56014|NCT02232126|E2|Reported Event|Intervention|SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
56015|NCT02232126|E1|Reported Event|Usual Care|Usual care for the present study constituted the usual course of care provided to older adults transitioning from hospital to home from Huntington Memorial Hospital.
56016|NCT02231918|B4|Baseline|Total|Total of all reporting groups
56017|NCT02231918|B3|Baseline|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
56018|NCT02231918|B2|Baseline|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
56019|NCT02231918|B1|Baseline|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
56020|NCT02231918|P3|Participant Flow|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
56021|NCT02231918|P2|Participant Flow|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
56022|NCT02231918|P1|Participant Flow|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
56023|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
56024|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
56025|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
56026|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
56027|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
56028|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
56029|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
56030|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
56031|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
56319|NCT02230566|B4|Baseline|Group D: 24 Weeks Placebo Then 4 mg/kg UX003|Placebo QOW for the first 24 weeks followed by 4 mg/kg UX003 QOW through Week 46
56033|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
56034|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
56035|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
56036|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
56037|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
56038|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
56039|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
56040|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
56041|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
56042|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
56043|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
56044|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
56045|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
56046|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
56047|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
56048|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
56049|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
56050|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
56051|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
56052|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
56053|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
56054|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
56055|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
56056|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
56057|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
56058|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
56059|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
56060|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
56061|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
56062|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
56063|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
56064|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
56065|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
56066|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
56067|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
56631|NCT02229318|O1|Outcome|FruitiVits|Daily administration of FruitiVits dietary supplement
56068|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
56069|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
56070|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
56071|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
56072|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
56073|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
56074|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
56075|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
56076|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
56077|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
56078|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
56079|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
56080|NCT02231918|E3|Reported Event|MIRAPEX® (0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
56081|NCT02231918|E2|Reported Event|MIRAPEX® (0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
56082|NCT02231918|E1|Reported Event|MIRAPEX® (0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
56083|NCT02231580|B3|Baseline|Total Title|
56084|NCT02231580|B2|Baseline|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56085|NCT02231580|B1|Baseline|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56086|NCT02231580|P2|Participant Flow|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56087|NCT02231580|P1|Participant Flow|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56165|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56166|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56172|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56088|NCT02231580|O2|Outcome|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56089|NCT02231580|O1|Outcome|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56090|NCT02231580|O2|Outcome|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56091|NCT02231580|O1|Outcome|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56092|NCT02231580|O2|Outcome|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56093|NCT02231580|O1|Outcome|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56094|NCT02231580|O2|Outcome|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56095|NCT02231580|O1|Outcome|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56167|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56632|NCT02229318|E1|Reported Event|FruitiVits|Daily administration of FruitiVits dietary supplement
56096|NCT02231580|O2|Outcome|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56097|NCT02231580|O1|Outcome|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56098|NCT02231580|O2|Outcome|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56099|NCT02231580|O1|Outcome|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56100|NCT02231580|O2|Outcome|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56101|NCT02231580|O1|Outcome|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56102|NCT02231580|O2|Outcome|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56103|NCT02231580|O1|Outcome|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56168|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56320|NCT02230566|B3|Baseline|Group C: 16 Weeks Placebo Then 4 mg/kg UX003|Placebo QOW for the first 16 weeks followed by 4 mg/kg UX003 QOW through Week 46
56104|NCT02231580|O2|Outcome|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56105|NCT02231580|O1|Outcome|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56106|NCT02231580|O2|Outcome|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56107|NCT02231580|O1|Outcome|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56108|NCT02231580|O2|Outcome|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56109|NCT02231580|O1|Outcome|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56110|NCT02231580|O2|Outcome|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56111|NCT02231580|O1|Outcome|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56169|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56633|NCT02229214|B3|Baseline|Total|Total of all reporting groups
56112|NCT02231580|O2|Outcome|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56113|NCT02231580|O1|Outcome|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56114|NCT02231580|O2|Outcome|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56115|NCT02231580|O1|Outcome|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56116|NCT02231580|O2|Outcome|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56117|NCT02231580|O1|Outcome|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56118|NCT02231580|O2|Outcome|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56119|NCT02231580|O1|Outcome|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56170|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56321|NCT02230566|B2|Baseline|Group B: 8 Weeks Placebo Then 4 mg/kg UX003|Placebo QOW for the first 8 weeks followed by 4 mg/kg UX003 QOW through Week 46
56120|NCT02231580|O2|Outcome|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56121|NCT02231580|O1|Outcome|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56122|NCT02231580|O2|Outcome|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56123|NCT02231580|O1|Outcome|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56124|NCT02231580|O2|Outcome|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56125|NCT02231580|O1|Outcome|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56126|NCT02231580|O2|Outcome|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56127|NCT02231580|O1|Outcome|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56171|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56322|NCT02230566|B1|Baseline|Group A: 4 mg/kg UX003|4 mg/kg UX003 QOW through Week 46
56128|NCT02231580|O2|Outcome|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56129|NCT02231580|O1|Outcome|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56130|NCT02231580|O2|Outcome|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56131|NCT02231580|O1|Outcome|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56132|NCT02231580|O2|Outcome|BN82451B Cohort 2|Patients randomised to receive BN82451B in cohort 2 received doses ranging from 60 to 80 mg BN82451B orally b.i.d. for up to 28 days.
56133|NCT02231580|O1|Outcome|BN82451B Cohort 1|Patients randomised to receive BN82451B in cohort 1 received doses ranging from 40 to 60 mg BN82451B orally b.i.d. for up to 28 days.
56134|NCT02231580|O2|Outcome|BN82451B Cohort 2|Patients randomised to receive BN82451B in cohort 2 received doses ranging from 60 to 80 mg BN82451B orally b.i.d. for up to 28 days.
56135|NCT02231580|O1|Outcome|BN82451B Cohort 1|Patients randomised to receive BN82451B in cohort 1 received doses ranging from 40 to 60 mg BN82451B orally b.i.d. for up to 28 days.
56136|NCT02231580|O2|Outcome|BN82451B Cohort 2|Patients randomised to receive BN82451B in cohort 2 received doses ranging from 60 to 80 mg BN82451B orally b.i.d. for up to 28 days.
56137|NCT02231580|O1|Outcome|BN82451B Cohort 1|Patients randomised to receive BN82451B in cohort 1 received doses ranging from 40 to 60 mg BN82451B orally b.i.d. for up to 28 days.
56138|NCT02231580|O2|Outcome|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56139|NCT02231580|O1|Outcome|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56140|NCT02231580|E2|Reported Event|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56634|NCT02229214|B2|Baseline|Placebo|"Days 1-28: Placebo~Placebo (sugar pill)"
56141|NCT02231580|E1|Reported Event|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
56142|NCT02231177|B1|Baseline|All Subjects|"A randomised, active-controlled, double-blind, 3-way crossover study in patients with COPD (chronic obstructive pulmonary disease). All participants received each of the three treatment arms in a randomly assigned order, the three treatments, which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg~Olodaterol 10 µg.~Tiotropium 5 µg."
56143|NCT02231177|P6|Participant Flow|Tio 5 μg, Olo 10 μg, Tio+Olo 5/10 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Tiotropium 5 µg.~Olodaterol 10 µg.~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg"
56144|NCT02231177|P5|Participant Flow|Tio 5 μg, Tio+Olo 5/10 μg, Olo 10 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Tiotropium 5 µg.~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg~Olodaterol 10 µg."
56145|NCT02231177|P4|Participant Flow|Olo 10 μg, Tio 5 μg, Tio+Olo 5/10 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Olodaterol 10 µg.~Tiotropium 5 µg.~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg"
56146|NCT02231177|P3|Participant Flow|Olo 10 μg, Tio+Olo 5/10 μg, Tio 5 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Olodaterol 10 µg.~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg~Tiotropium 5 µg."
56147|NCT02231177|P2|Participant Flow|Tio+Olo 5/10 μg, Tio 5 μg, Olo 10 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg~Tiotropium 5 µg.~Olodaterol 10 µg."
56148|NCT02231177|P1|Participant Flow|Tio+Olo 5/10 μg, Olo 10 μg, Tio 5 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg~Olodaterol (Olo) 10 µg.~Tiotropium (Tio) 5 µg."
56149|NCT02231177|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56150|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56151|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56152|NCT02231177|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56153|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56154|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56155|NCT02231177|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56156|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56157|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56158|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56159|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56160|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56161|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56162|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56163|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56164|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56173|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56174|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56175|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56176|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56177|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56178|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56179|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56180|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56181|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56182|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56183|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56184|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56185|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56186|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56187|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56188|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56189|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56190|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56191|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56192|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56193|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56194|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56195|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56196|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56197|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56198|NCT02231177|E3|Reported Event|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56199|NCT02231177|E2|Reported Event|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56200|NCT02231177|E1|Reported Event|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
56201|NCT02231164|B3|Baseline|Total|Total of all reporting groups
56219|NCT02230995|O2|Outcome|Fed 25mg+1000mg Single|Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
94380|NCT02004886|O4|Outcome|Placebo|Placebo
56202|NCT02231164|B2|Baseline|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
56203|NCT02231164|B1|Baseline|Placebo|Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
56204|NCT02231164|P2|Participant Flow|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
56205|NCT02231164|P1|Participant Flow|Placebo|Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
56206|NCT02231164|O2|Outcome|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
56207|NCT02231164|O1|Outcome|Placebo|Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
56208|NCT02231164|E2|Reported Event|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
56209|NCT02231164|E1|Reported Event|Placebo|Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
56210|NCT02230995|B3|Baseline|Total|Total of all reporting groups
56211|NCT02230995|B2|Baseline|Fed 25mg+1000mg Single/FDC|"Subjects received in period 1 a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 25 mg empagliflozin/1000 mg metformin HCl XR (1 FDC tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.~2 treatments separated by a wash-out period of at least 7 days."
56212|NCT02230995|B1|Baseline|Fed 25mg+1000mg FDC/Single|"Subjects received in period 1 a single dose of 25 mg empagliflozin/1000 mg metformin HCl XR (1 FDC tablet) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.~2 treatments separated by a wash-out period of at least 7 days."
56213|NCT02230995|P2|Participant Flow|Fed 25mg+1000mg Single/FDC|"Subjects received in period 1 a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 25 mg empagliflozin/1000 mg metformin HCl XR (1 FDC tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.~2 treatments separated by a wash-out period of at least 7 days."
56214|NCT02230995|P1|Participant Flow|Fed 25mg+1000mg FDC/Single|"Subjects received in period 1 a single dose of 25 mg empagliflozin/1000 mg metformin HCl XR (1 FDC tablet) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.~2 treatments separated by a wash-out period of at least 7 days."
56215|NCT02230995|O2|Outcome|Fed 25mg+1000mg Single|Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
56216|NCT02230995|O1|Outcome|Fed 25mg+1000mg FDC|Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
56217|NCT02230995|O2|Outcome|Fed 25mg+1000mg Single|Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
56218|NCT02230995|O1|Outcome|Fed 25mg+1000mg FDC|Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
56305|NCT02230670|B3|Baseline|Total|Total of all reporting groups
56306|NCT02230670|B2|Baseline|Placebo|"Placebo BID~Placebo"
56220|NCT02230995|O1|Outcome|Fed 25mg+1000mg FDC|Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
56221|NCT02230995|O2|Outcome|Fed 25mg+1000mg Single|Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
56222|NCT02230995|O1|Outcome|Fed 25mg+1000mg FDC|Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
56223|NCT02230995|O2|Outcome|Fed 25mg+1000mg Single|Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
56224|NCT02230995|O1|Outcome|Fed 25mg+1000mg FDC|Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
56225|NCT02230995|O2|Outcome|Fed 25mg+1000mg Single|Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
56226|NCT02230995|O1|Outcome|Fed 25mg+1000mg FDC|Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
56227|NCT02230995|E2|Reported Event|Fed 25mg+1000mg Single|Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
56228|NCT02230995|E1|Reported Event|Fed 25mg+1000mg FDC|Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
56229|NCT02230956|B4|Baseline|Total|Total of all reporting groups
56230|NCT02230956|B3|Baseline|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
56231|NCT02230956|B2|Baseline|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
56232|NCT02230956|B1|Baseline|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
56233|NCT02230956|P3|Participant Flow|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
56234|NCT02230956|P2|Participant Flow|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
56235|NCT02230956|P1|Participant Flow|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
56236|NCT02230956|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
56237|NCT02230956|O2|Outcome|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
56238|NCT02230956|O1|Outcome|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
56239|NCT02230956|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
56240|NCT02230956|O2|Outcome|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
56241|NCT02230956|O1|Outcome|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
56242|NCT02230956|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
56243|NCT02230956|O2|Outcome|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
56244|NCT02230956|O1|Outcome|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
56245|NCT02230956|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
56246|NCT02230956|O2|Outcome|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
56247|NCT02230956|O1|Outcome|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
56248|NCT02230956|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
56249|NCT02230956|O2|Outcome|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
56250|NCT02230956|O1|Outcome|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
56251|NCT02230956|E3|Reported Event|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
56252|NCT02230956|E2|Reported Event|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
56253|NCT02230956|E1|Reported Event|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
56254|NCT02230904|B3|Baseline|Total Title|
56255|NCT02230904|B2|Baseline|Treatment Arm B-A|4 day treatment (Treatment B for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 followed by Treatment A for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1)
56256|NCT02230904|B1|Baseline|Treatment Arm A-B|4 day treatment (Treatment A for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 followed by Treatment B for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1)
56257|NCT02230904|P2|Participant Flow|Treatment Arm B-A|4 day treatment (Treatment B for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 followed by Treatment A for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1)
56307|NCT02230670|B1|Baseline|IDN-6556|"25 mg BID of IDN-6556~IDN-6556: 25 mg BID"
56258|NCT02230904|P1|Participant Flow|Treatment Arm A-B|4 day treatment (Treatment A for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 followed by Treatment B for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1)
56259|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence B-A and Day 3 and Day 4 for subjects in Treatment Sequence A-B).
56260|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence A-B and Day 3 and Day 4 for subjects in Treatment Sequence B-A).
56261|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1
56262|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1
56263|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1
56264|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1
56265|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1
56266|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1
56267|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1
56268|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1
56269|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1
56270|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1
56271|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1
56272|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1
56273|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence B-A and Day 3 and Day 4 for subjects in Treatment Sequence A-B).
56274|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence A-B and Day 3 and Day 4 for subjects in Treatment Sequence B-A).
56275|NCT02230904|E2|Reported Event|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence B-A and Day 3 and Day 4 for subjects in Treatment Sequence A-B).
56276|NCT02230904|E1|Reported Event|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence A-B and Day 3 and Day 4 for subjects in Treatment Sequence B-A).
56277|NCT02230761|B3|Baseline|Total|Total of all reporting groups
56278|NCT02230761|B2|Baseline|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.~Placebo"
56279|NCT02230761|B1|Baseline|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.~XOPH5 Ointment"
56280|NCT02230761|P2|Participant Flow|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.~Placebo"
56281|NCT02230761|P1|Participant Flow|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.~XOPH5 Ointment"
56282|NCT02230761|O2|Outcome|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.~Placebo"
56283|NCT02230761|O1|Outcome|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.~XOPH5 Ointment"
56284|NCT02230761|O2|Outcome|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.~Placebo"
56285|NCT02230761|O1|Outcome|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.~XOPH5 Ointment"
56286|NCT02230761|O2|Outcome|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.~Placebo"
56287|NCT02230761|O1|Outcome|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.~XOPH5 Ointment"
56288|NCT02230761|E2|Reported Event|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.~Placebo"
56289|NCT02230761|E1|Reported Event|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.~XOPH5 Ointment"
56290|NCT02230683|B1|Baseline|IDN-6556|IDN-6556 25 mg Dosed twice daily
56291|NCT02230683|P1|Participant Flow|IDN-6556|IDN-6556 25 mg Dosed twice daily
56292|NCT02230683|O1|Outcome|IDN-6556|Overall evaluable population treated with IDN-6556 25 mg twice daily
56293|NCT02230683|O1|Outcome|IDN-6556|Overall evaluable population treated with IDN-6556 25 mg twice daily
56294|NCT02230683|O1|Outcome|IDN-6556|Overall evaluable population treated with IDN-6556 25 mg twice daily
56295|NCT02230683|O3|Outcome|IDN-6556 - Subgroup HVPG ≥ 12 mmHg|Subgroup for patients with HVPG ≥ 12 mmHg that have been treated with IDN-6556 25 mg twice daily
56296|NCT02230683|O2|Outcome|IDN-6556 - Subgroup With HVPG < 12 mmHg|Subgroup for patients with HVPG < 12 mmHg that have been treated with IDN-6556 25 mg twice daily
56297|NCT02230683|O1|Outcome|IDN-6556 - Overall Population|Overall evaluable population treated with IDN-6556 25 mg twice daily
56298|NCT02230683|O3|Outcome|IDN-6556 - Subgroup HVPG ≥ 12 mmHg|Subgroup for patients with Baseline HVPG ≥ 12 mmHg that have been treated with IDN-6556 25 mg twice daily
56299|NCT02230683|O2|Outcome|IDN-6556 - Subgroup With HVPG < 12 mmHg|Subgroup for patients with Baseline HVPG < 12 mmHg that have been treated with IDN-6556 25 mg twice daily
56300|NCT02230683|O1|Outcome|IDN-6556 - Overall Population|Overall evaluable population treated with IDN-6556 25 mg twice daily
56301|NCT02230683|O3|Outcome|IDN-6556 - Subgroup HVPG ≥ 12 mmHg|Subgroup for patients with HVPG ≥ 12 mmHg that have been treated with IDN-6556 25 mg twice daily
56302|NCT02230683|O2|Outcome|IDN-6556 - Subgroup With HVPG < 12 mmHg|Subgroup for patients with HVPG < 12 mmHg that have been treated with IDN-6556 25 mg twice daily
56303|NCT02230683|O1|Outcome|IDN-6556 - Overall Population|Overall evaluable population treated with IDN-6556 25 mg twice daily with HVPG measurement at Baseline and Day 28
56304|NCT02230683|E1|Reported Event|IDN-6556|IDN-6556 25 mg Dosed twice daily
56323|NCT02230566|P4|Participant Flow|Group D: 24 Weeks Placebo Then 4 mg/kg UX003|Placebo QOW for the first 24 weeks followed by 4 mg/kg UX003 QOW through Week 46
56324|NCT02230566|P3|Participant Flow|Group C: 16 Weeks Placebo Then 4 mg/kg UX003|Placebo QOW for the first 16 weeks followed by 4 mg/kg UX003 QOW through Week 46
56325|NCT02230566|P2|Participant Flow|Group B: 8 Weeks Placebo Then 4 mg/kg UX003|Placebo QOW for the first 8 weeks followed by 4 mg/kg UX003 QOW through Week 46
56326|NCT02230566|P1|Participant Flow|Group A: 4 mg/kg UX003|4 mg/kg UX003 every other week (QOW) through Week 46
56327|NCT02230566|O1|Outcome|UX003 4 mg/kg|Participants were randomized 1:1:1:1 to 1 of 4 treatment sequence groups to either start treatment with 4 mg/kg UX003 (Group A), or placebo for the first 8 weeks (Group B), 16 weeks (Group C) or 24 weeks (Group D) of the study and cross over to 4 mg/kg UX003. Participants were dosed QOW through Week 46. All groups received a minimum of 24 weeks of treatment with 4 mg/kg UX003 QOW.
56328|NCT02230566|O1|Outcome|UX003 4 mg/kg|Participants were randomized 1:1:1:1 to 1 of 4 treatment sequence groups to either start treatment with 4 mg/kg UX003 (Group A), or placebo for the first 8 weeks (Group B), 16 weeks (Group C) or 24 weeks (Group D) of the study and cross over to 4 mg/kg UX003. Participants were dosed QOW through Week 46. All groups received a minimum of 24 weeks of treatment with 4 mg/kg UX003 QOW.
56329|NCT02230566|O1|Outcome|UX003 4 mg/kg|Participants were randomized 1:1:1:1 to 1 of 4 treatment sequence groups to either start treatment with 4 mg/kg UX003 (Group A), or placebo for the first 8 weeks (Group B), 16 weeks (Group C) or 24 weeks (Group D) of the study and cross over to 4 mg/kg UX003. Participants were dosed QOW through Week 46. All groups received a minimum of 24 weeks of treatment with 4 mg/kg UX003 QOW.
56330|NCT02230566|O1|Outcome|UX003 4 mg/kg|Participants were randomized 1:1:1:1 to 1 of 4 treatment sequence groups to either start treatment with 4 mg/kg UX003 (Group A), or placebo for the first 8 weeks (Group B), 16 weeks (Group C) or 24 weeks (Group D) of the study and cross over to 4 mg/kg UX003. Participants were dosed QOW through Week 46. All groups received a minimum of 24 weeks of treatment with 4 mg/kg UX003 QOW.
56331|NCT02230566|O1|Outcome|UX003 4 mg/kg|Participants were randomized 1:1:1:1 to 1 of 4 treatment sequence groups to either start treatment with 4 mg/kg UX003 (Group A), or placebo for the first 8 weeks (Group B), 16 weeks (Group C) or 24 weeks (Group D) of the study and cross over to 4 mg/kg UX003. Participants were dosed QOW through Week 46. All groups received a minimum of 24 weeks of treatment with 4 mg/kg UX003 QOW.
56332|NCT02230566|O1|Outcome|UX003 4 mg/kg|Participants were randomized 1:1:1:1 to 1 of 4 treatment sequence groups to either start treatment with 4 mg/kg UX003 (Group A), or placebo for the first 8 weeks (Group B), 16 weeks (Group C) or 24 weeks (Group D) of the study and cross over to 4 mg/kg UX003. Participants were dosed QOW through Week 46. All groups received a minimum of 24 weeks of treatment with 4 mg/kg UX003 QOW.
56333|NCT02230566|O1|Outcome|UX003 4 mg/kg|Participants were randomized 1:1:1:1 to 1 of 4 treatment sequence groups to either start treatment with 4 mg/kg UX003 (Group A), or placebo for the first 8 weeks (Group B), 16 weeks (Group C) or 24 weeks (Group D) of the study and cross over to 4 mg/kg UX003. Participants were dosed QOW through Week 46. All groups received a minimum of 24 weeks of treatment with 4 mg/kg UX003 QOW.
56334|NCT02230566|O1|Outcome|UX003 4 mg/kg|Participants were randomized 1:1:1:1 to 1 of 4 treatment sequence groups to either start treatment with 4 mg/kg UX003 (Group A), or placebo for the first 8 weeks (Group B), 16 weeks (Group C) or 24 weeks (Group D) of the study and cross over to 4 mg/kg UX003. Participants were dosed QOW through Week 46. All groups received a minimum of 24 weeks of treatment with 4 mg/kg UX003 QOW.
56335|NCT02230566|O1|Outcome|UX003 4 mg/kg|Participants were randomized 1:1:1:1 to 1 of 4 treatment sequence groups to either start treatment with 4 mg/kg UX003 (Group A), or placebo for the first 8 weeks (Group B), 16 weeks (Group C) or 24 weeks (Group D) of the study and cross over to 4 mg/kg UX003. Participants were dosed QOW through Week 46. All groups received a minimum of 24 weeks of treatment with 4 mg/kg UX003 QOW.
56336|NCT02230566|O1|Outcome|UX003 4 mg/kg|Participants were randomized 1:1:1:1 to 1 of 4 treatment sequence groups to either start treatment with 4 mg/kg UX003 (Group A), or placebo for the first 8 weeks (Group B), 16 weeks (Group C) or 24 weeks (Group D) of the study and cross over to 4 mg/kg UX003. Participants were dosed QOW through Week 46. All groups received a minimum of 24 weeks of treatment with 4 mg/kg UX003 QOW.
56337|NCT02230566|O1|Outcome|UX003 4 mg/kg|Participants were randomized 1:1:1:1 to 1 of 4 treatment sequence groups to either start treatment with 4 mg/kg UX003 (Group A), or placebo for the first 8 weeks (Group B), 16 weeks (Group C) or 24 weeks (Group D) of the study and cross over to 4 mg/kg UX003. Participants were dosed QOW through Week 46. All groups received a minimum of 24 weeks of treatment with 4 mg/kg UX003 QOW.
56338|NCT02230566|E2|Reported Event|UX003 Active Treatment|Participants received 4 mg/kg UX003 QOW per group assignment (based on the blind-start design) and were dosed through Week 46. All groups received a minimum of 24 weeks of treatment with UX003.
56339|NCT02230566|E1|Reported Event|Placebo|Participants received placebo for the first 8 weeks (Group B), 16 weeks (Group C) or 24 weeks (Group D) of the study, based on the blind-start design.
56340|NCT02230540|B1|Baseline|Sequence A|"Catheterization with SelfCath (comparator) followed by measurement of residual urine.~Then catheterization with Product A in different positions and measurement of residual urine.~SelfCath (comparator): Catheter for urinary drainage.~Product A: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices)."
56341|NCT02230540|P2|Participant Flow|Sequence B|"Based on results from sequence A, sequence B may or may not be initiated.~Catheterization with SelfCath (comparator) followed by measurement of residual urine.~Then catheterization with Product B in different positions. Measurement of residual urine at different positions.~SelfCath (comparator): Commercially available CE-marked catheter for urinary drainage.~Product B SelfCath and urine bag, Conveen Contour: SelfCath and urine bag, Conveen Contour (both commercially available CE-marked devices)."
56342|NCT02230540|P1|Participant Flow|Sequence A|"Catheterization with SelfCath (comparator) followed by measurement of residual urine.~Then catheterization with Product A in different positions. Measurement of residual urine at different positions.~SelfCath (comparator): Commercially available CE-marked catheter for urinary drainage.~Product A SelfCath and urine bag, Conveen Security+: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices)."
56377|NCT02230306|O1|Outcome|Cobimetinib in Combination With Vemurafenib|Vemurafenib (960 mg twice a day) taken on Days 1 - 28 of each 28-day treatment cycle. Cobimetinib (60 mg once a day) taken on Days 1 - 21 of each 28-day treatment cycle.
56343|NCT02230540|O1|Outcome|Sequence A|"Catheterization with SelfCath (comparator) followed by measurement of residual urine.~Then catheterization with Product A in different positions and measurement of residual urine.~SelfCath (comparator): Catheter for urinary drainage.~Product A: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices)."
56344|NCT02230540|E1|Reported Event|Sequence A|"Catheterization with SelfCath (comparator) followed by measurement of residual urine.~Then catheterization with Product A in different positions and measurement of residual urine.~SelfCath (comparator): Catheter for urinary drainage.~Product A: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices)."
56345|NCT02230384|B3|Baseline|Total|Total of all reporting groups
56346|NCT02230384|B2|Baseline|Placebo Pill Then Active JNJ Drug|"Placebo pill used for one week quit attempt, as part of crossover design.~Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week~Placebo Pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week"
56347|NCT02230384|B1|Baseline|Active JNJ Drug Then Placebo|"200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design. This JNJ experimental compound has NO name, just a company number.~Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week~Placebo Pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week"
56348|NCT02230384|P2|Participant Flow|Placebo Pill Then Active JNJ Drug|"Placebo pill used for one week quit attempt, as part of crossover design.~Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week~Placebo Pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week"
56349|NCT02230384|P1|Participant Flow|Active JNJ Drug Then Placebo|"200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design. This JNJ experimental compound has NO name, just a company number.~Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week~Placebo Pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week"
56350|NCT02230384|O2|Outcome|Placebo Pill Then Active JNJ Drug|"Placebo pill used for one week quit attempt, as part of crossover design.~Participants who received Placebo pill: 200 mg/day (100 mg b.i.d.) of Placebo for one week while attempting to briefly quit smoking on Mon-Fri of either the first and JNJ in the second phase"
56351|NCT02230384|O1|Outcome|Active JNJ Drug Then Placebo|Participants who received Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug for one week while attempting to briefly quit smoking on Mon-Fri of either the first phase of the study and placebo in the second phase
56352|NCT02230384|E2|Reported Event|Placebo Pill Then Active JNJ Drug|"Placebo pill used for one week quit attempt, as part of crossover design.~Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week~Placebo Pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week"
56353|NCT02230384|E1|Reported Event|Active JNJ Drug Then Placebo|"200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design. This JNJ experimental compound has NO name, just a company number.~Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week~Placebo Pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week"
56354|NCT02230332|B3|Baseline|Total|Total of all reporting groups
56355|NCT02230332|B2|Baseline|Placebo|"Placebo capsule taken once daily~Placebo"
56356|NCT02230332|B1|Baseline|Alendronate|"Alendronate in 10mg capsules taken once daily~Alendronate"
56357|NCT02230332|P2|Participant Flow|Placebo|"Placebo capsule taken once daily~Placebo"
56358|NCT02230332|P1|Participant Flow|Alendronate|"Alendronate in 10mg capsules taken once daily~Alendronate"
56359|NCT02230332|O2|Outcome|Placebo|"Placebo capsule taken once daily~Placebo"
56360|NCT02230332|O1|Outcome|Alendronate|"Alendronate in 10mg capsules taken once daily~Alendronate"
56361|NCT02230332|O2|Outcome|Placebo|"Placebo capsule taken once daily~Placebo"
56362|NCT02230332|O1|Outcome|Alendronate|"Alendronate in 10mg capsules taken once daily~Alendronate"
56363|NCT02230332|O2|Outcome|Placebo|"Placebo capsule taken once daily~Placebo"
56364|NCT02230332|O1|Outcome|Alendronate|"Alendronate in 10mg capsules taken once daily~Alendronate"
56365|NCT02230332|O2|Outcome|Placebo|"Placebo capsule taken once daily~Placebo"
56366|NCT02230332|O1|Outcome|Alendronate|"Alendronate in 10mg capsules taken once daily~Alendronate"
56367|NCT02230332|O2|Outcome|Placebo|"Placebo capsule taken once daily~Placebo"
56368|NCT02230332|O1|Outcome|Alendronate|"Alendronate in 10mg capsules taken once daily~Alendronate"
56369|NCT02230332|O2|Outcome|Placebo|"Placebo capsule taken once daily~Placebo"
56370|NCT02230332|O1|Outcome|Alendronate|"Alendronate in 10mg capsules taken once daily~Alendronate"
56371|NCT02230332|E2|Reported Event|Placebo|"Placebo capsule taken once daily~Placebo"
56372|NCT02230332|E1|Reported Event|Alendronate|"Alendronate in 10mg capsules taken once daily~Alendronate"
56373|NCT02230306|B1|Baseline|Cobimetinib in Combination With Vemurafenib|Vemurafenib (960 mg twice a day) taken on Days 1 - 28 of each 28-day treatment cycle. Cobimetinib (60 mg once a day) taken on Days 1 - 21 of each 28-day treatment cycle.
56374|NCT02230306|P1|Participant Flow|Cobimetinib in Combination With Vemurafenib|Vemurafenib (960 mg twice a day) taken on Days 1 - 28 of each 28-day treatment cycle. Cobimetinib (60 mg once a day) taken on Days 1 - 21 of each 28-day treatment cycle.
56375|NCT02230306|O1|Outcome|Cobimetinib in Combination With Vemurafenib|Vemurafenib (960 mg twice a day) taken on Days 1 - 28 of each 28-day treatment cycle. Cobimetinib (60 mg once a day) taken on Days 1 - 21 of each 28-day treatment cycle.
56376|NCT02230306|O1|Outcome|Cobimetinib in Combination With Vemurafenib|Vemurafenib (960 mg twice a day) taken on Days 1 - 28 of each 28-day treatment cycle. Cobimetinib (60 mg once a day) taken on Days 1 - 21 of each 28-day treatment cycle.
56578|NCT02229396|P2|Participant Flow|Exenatide + Dapagliflozin|Exenatide 2 mg 1 time per week + Dapagliflozin 10 mg once daily added to metformin
56378|NCT02230306|O1|Outcome|Cobimetinib in Combination With Vemurafenib|Vemurafenib (960 mg twice a day) taken on Days 1 - 28 of each 28-day treatment cycle. Cobimetinib (60 mg once a day) taken on Days 1 - 21 of each 28-day treatment cycle.
56379|NCT02230306|O1|Outcome|Cobimetinib in Combination With Vemurafenib|Vemurafenib (960 mg twice a day) taken on Days 1 - 28 of each 28-day treatment cycle. Cobimetinib (60 mg once a day) taken on Days 1 - 21 of each 28-day treatment cycle.
56380|NCT02230306|O1|Outcome|Cobimetinib in Combination With Vemurafenib|Vemurafenib (960 mg twice a day) taken on Days 1 - 28 of each 28-day treatment cycle. Cobimetinib (60 mg once a day) taken on Days 1 - 21 of each 28-day treatment cycle.
56381|NCT02230306|O1|Outcome|Cobimetinib in Combination With Vemurafenib|Vemurafenib (960 mg twice a day) taken on Days 1 - 28 of each 28-day treatment cycle. Cobimetinib (60 mg once a day) taken on Days 1 - 21 of each 28-day treatment cycle.
56382|NCT02230306|O1|Outcome|Cobimetinib in Combination With Vemurafenib|Vemurafenib (960 mg twice a day) taken on Days 1 - 28 of each 28-day treatment cycle. Cobimetinib (60 mg once a day) taken on Days 1 - 21 of each 28-day treatment cycle.
56383|NCT02230306|E1|Reported Event|Cobimetinib in Combination With Vemurafenib|Vemurafenib (960 mg twice a day) taken on Days 1 - 28 of each 28-day treatment cycle. Cobimetinib (60 mg once a day) taken on Days 1 - 21 of each 28-day treatment cycle.
56384|NCT02230085|B1|Baseline|CPAP Therapy|Administration of the questionnaire and monitoring of CPAP adherence
56385|NCT02230085|P1|Participant Flow|CPAP Therapy|Administration of the questionnaire and monitoring of CPAP adherence
56386|NCT02230085|O1|Outcome|CPAP Therapy|Administration of the questionnaire and monitoring of CPAP adherence
56387|NCT02230085|E1|Reported Event|CPAP Therapy|Administration of the questionnaire and monitoring of CPAP adherence
56388|NCT02229864|B1|Baseline|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)~Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~• Scaffold lengths: 8, 12, 18, and 28 mm"
56389|NCT02229864|P1|Participant Flow|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)~Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~• Scaffold lengths: 8, 12, 18, and 28 mm"
56390|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56391|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56392|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56393|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56394|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56395|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56396|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56397|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56398|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56399|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56400|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56401|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56402|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56403|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56404|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56405|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56406|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
94570|NCT02003963|B3|Baseline|Total|Total of all reporting groups
56407|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56408|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56409|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56410|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56411|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56412|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56413|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56414|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56415|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56416|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56417|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56418|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56419|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56420|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56421|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56422|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56423|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56424|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56425|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56426|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56427|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56428|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56429|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56430|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56431|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56432|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56630|NCT02229318|O1|Outcome|FruitiVits|Administration of FruitiVits dietary supplement
56433|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56434|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56435|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56436|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56437|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56438|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
56439|NCT02229864|E1|Reported Event|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)~Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~• Scaffold lengths: 8, 12, 18, and 28 mm"
56440|NCT02229539|B4|Baseline|Total|Total of all reporting groups
56441|NCT02229539|B3|Baseline|Placebo|Patients receive 2.5 mL placebo and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
56442|NCT02229539|B2|Baseline|DLA (Diphenhydramine, Lidocaine and Antacid)|Patients receive 5.0 mL DLA orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
56443|NCT02229539|B1|Baseline|Doxepin|Patients receive 2.5 mL (25 mg) doxepin and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
56444|NCT02229539|P3|Participant Flow|Placebo|Patients receive 2.5 mL placebo and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
56445|NCT02229539|P2|Participant Flow|DLA (Diphenhydramine, Lidocaine and Antacid)|Patients receive 5.0 mL DLA orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
56446|NCT02229539|P1|Participant Flow|Doxepin|Patients receive 2.5 mL (25 mg) doxepin and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
56447|NCT02229539|O3|Outcome|Placebo|Patients receive 2.5 mL placebo and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
56448|NCT02229539|O2|Outcome|DLA (Diphenhydramine, Lidocaine and Antacid)|Patients receive 5.0 mL DLA orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
56449|NCT02229539|O1|Outcome|Doxepin|Patients receive 2.5 mL (25 mg) doxepin and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
56450|NCT02229539|E3|Reported Event|Placebo|Patients receive 2.5 mL placebo and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
56451|NCT02229539|E2|Reported Event|DLA (Diphenhydramine, Lidocaine and Antacid)|Patients receive 5.0 mL DLA orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
56452|NCT02229539|E1|Reported Event|Doxepin|Patients receive 2.5 mL (25 mg) doxepin and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
56453|NCT02229513|B3|Baseline|Total|Total of all reporting groups
56454|NCT02229513|B2|Baseline|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
56455|NCT02229513|B1|Baseline|Control|Normal cesarean technique.
56456|NCT02229513|P2|Participant Flow|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
56457|NCT02229513|P1|Participant Flow|Control|Normal cesarean technique.
56458|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
56459|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
56506|NCT02229474|O2|Outcome|Group 2|and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.
56460|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
56461|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
56462|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
56463|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
56464|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
56465|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
56466|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
56467|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
56468|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
56469|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
56470|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
56471|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
56472|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
56473|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
56474|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
56475|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
56476|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
56477|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
56478|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
56479|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
56480|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
56481|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
56574|NCT02229396|B3|Baseline|Exenatide + Placebo|Exenatide 2 mg 1 time per week + Placebo 10 mg once daily added to metformin
56482|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
56483|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
56484|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
56485|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
56486|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
56487|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
56488|NCT02229513|E2|Reported Event|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
56489|NCT02229513|E1|Reported Event|Control|Normal cesarean technique.
56490|NCT02229487|B3|Baseline|Total|Total of all reporting groups
56491|NCT02229487|B2|Baseline|Short Sleeper|Sleep duration as measured by actigraphy =<5.75 h/night
56492|NCT02229487|B1|Baseline|Normal Sleeper|Sleep duration as measured by actigraphy >=6.5 h/night
56493|NCT02229487|P2|Participant Flow|Short Sleepers|"Prediabetes patients with short sleep duration (=<5.75 hours/night) as measured objectively~Oral glucose tolerance"
56494|NCT02229487|P1|Participant Flow|Normal Sleepers|"Prediabetes patients with normal sleep duration (>=6.5 hours/ night) as measured objectively~Oral glucose tolerance"
56495|NCT02229487|O2|Outcome|Normal Sleepers|Sleep duration as measured by actigraphy >=6.5h/night
56496|NCT02229487|O1|Outcome|Short Sleepers|Sleep duration as measured by actigraphy =<5.75 h/night
56497|NCT02229487|E2|Reported Event|Short Sleeper|Sleep duration as measured by actigraphy =<5.7 h/night
56498|NCT02229487|E1|Reported Event|Normal Sleeper|Sleep duration as measured by actigraphy >=6.5 h/night
56499|NCT02229474|B3|Baseline|Total|Total of all reporting groups
56500|NCT02229474|B2|Baseline|Group 2|and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.
56501|NCT02229474|B1|Baseline|CST Intervention|"We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.~In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.~CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve outcomes"
56502|NCT02229474|P2|Participant Flow|Group 2|and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.
56503|NCT02229474|P1|Participant Flow|CST Intervention|"We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.~CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life. Sessions will be led and facilitated by a study nurse or occupational therapist. The sessions will be held at a local health centre of village hall."
56504|NCT02229474|O2|Outcome|Group 2|and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.
56505|NCT02229474|O1|Outcome|CST Intervention|"We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.~In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.~CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life."
56507|NCT02229474|O1|Outcome|CST Intervention|"We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.~In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.~CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life."
56508|NCT02229474|O2|Outcome|Group 2|and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.
56509|NCT02229474|O1|Outcome|CST Intervention|"We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.~In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.~CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life."
56510|NCT02229474|O2|Outcome|Group 2|and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.
56511|NCT02229474|O1|Outcome|CST Intervention|"We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.~In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.~CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life."
56512|NCT02229474|O2|Outcome|Group 2|and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.
56513|NCT02229474|O1|Outcome|CST Intervention|"We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.~In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.~CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life."
56514|NCT02229474|O2|Outcome|Group 2|and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.
56515|NCT02229474|O1|Outcome|CST Intervention|"We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.~In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.~CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life."
56516|NCT02229474|O2|Outcome|Group 2|and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.
56517|NCT02229474|O1|Outcome|CST Intervention|"We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.~In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.~CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life."
56575|NCT02229396|B2|Baseline|Exenatide + Dapagliflozin|Exenatide 2 mg 1 time per week + Dapagliflozin 10 mg once daily added to metformin
56518|NCT02229474|O2|Outcome|Group 2|and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.
56519|NCT02229474|O1|Outcome|CST Intervention|"We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.~In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location."
56520|NCT02229474|O2|Outcome|Group 2|and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.
56521|NCT02229474|O1|Outcome|CST Intervention|"We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.~In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.~CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life."
56522|NCT02229474|O2|Outcome|Group 2|and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.
56523|NCT02229474|O1|Outcome|CST Intervention|"We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.~In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.~CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life."
56524|NCT02229474|O2|Outcome|Group 2|and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.
56525|NCT02229474|O1|Outcome|CST Intervention|"We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.~In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.~CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life."
56526|NCT02229474|E2|Reported Event|Group 2|and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.
56527|NCT02229474|E1|Reported Event|CST Intervention|"We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.~In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.~CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life."
56528|NCT02229461|B8|Baseline|Total|Total of all reporting groups
56529|NCT02229461|B7|Baseline|Non-Randomized|Fifteen participants were not randomized into Treatment Period.
56530|NCT02229461|B6|Baseline|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56531|NCT02229461|B5|Baseline|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56532|NCT02229461|B4|Baseline|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56576|NCT02229396|B1|Baseline|Dapagliflozin + Placebo|Dapagliflozin 10 mg once daily + Placebo 2 mg 1 time per week added to metformin
56533|NCT02229461|B3|Baseline|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56534|NCT02229461|B2|Baseline|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56535|NCT02229461|B1|Baseline|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56536|NCT02229461|P6|Participant Flow|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56537|NCT02229461|P5|Participant Flow|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56538|NCT02229461|P4|Participant Flow|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56539|NCT02229461|P3|Participant Flow|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56540|NCT02229461|P2|Participant Flow|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56541|NCT02229461|P1|Participant Flow|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56542|NCT02229461|O6|Outcome|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56543|NCT02229461|O5|Outcome|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56544|NCT02229461|O4|Outcome|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56545|NCT02229461|O3|Outcome|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56546|NCT02229461|O2|Outcome|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56547|NCT02229461|O1|Outcome|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56548|NCT02229461|O6|Outcome|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56549|NCT02229461|O5|Outcome|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56550|NCT02229461|O4|Outcome|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56551|NCT02229461|O3|Outcome|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56552|NCT02229461|O2|Outcome|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56577|NCT02229396|P3|Participant Flow|Exenatide + Placebo|Exenatide 2 mg 1 time per week + Placebo 10 mg once daily added to metformin
95281|NCT01998737|E1|Reported Event|Women Under Osteoporosis Suspicion|
56553|NCT02229461|O1|Outcome|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56554|NCT02229461|O6|Outcome|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56555|NCT02229461|O5|Outcome|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56556|NCT02229461|O4|Outcome|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56557|NCT02229461|O3|Outcome|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56558|NCT02229461|O2|Outcome|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56559|NCT02229461|O1|Outcome|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56560|NCT02229461|O6|Outcome|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56561|NCT02229461|O5|Outcome|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56562|NCT02229461|O4|Outcome|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56563|NCT02229461|O3|Outcome|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56564|NCT02229461|O2|Outcome|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56565|NCT02229461|O1|Outcome|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56566|NCT02229461|E7|Reported Event|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56567|NCT02229461|E6|Reported Event|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56568|NCT02229461|E5|Reported Event|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56569|NCT02229461|E4|Reported Event|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56570|NCT02229461|E3|Reported Event|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56571|NCT02229461|E2|Reported Event|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
56572|NCT02229461|E1|Reported Event|Group 0-IR ASA 81 mg qd in Run-in Period|Participants, subsequently randomized to treatment period, were administered the first dose of immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily at the clinical study site and instructed to take the remaining 5 doses in a fasted state with a full glass of water once daily in the morning in an outpatient setting.
56573|NCT02229396|B4|Baseline|Total|Total of all reporting groups
95282|NCT01998581|B3|Baseline|Total|Total of all reporting groups
56579|NCT02229396|P1|Participant Flow|Dapagliflozin + Placebo|Dapagliflozin 10 mg once daily + Placebo 2 mg 1 time per week added to metformin
56580|NCT02229396|O3|Outcome|Exenatide + Placebo|Exenatide 2 mg 1 time per week + Placebo 10 mg once daily added to metformin
56581|NCT02229396|O2|Outcome|Exenatide + Dapagliflozin|Exenatide 2 mg 1 time per week + Dapagliflozin 10 mg once daily added to metformin
56582|NCT02229396|O1|Outcome|Dapagliflozin + Placebo|Dapagliflozin 10 mg once daily + Placebo 2 mg 1 time per week added to metformin
56583|NCT02229396|O3|Outcome|Exenatide + Placebo|Exenatide 2 mg 1 time per week + Placebo 10 mg once daily added to metformin
56584|NCT02229396|O2|Outcome|Exenatide + Dapagliflozin|Exenatide 2 mg 1 time per week + Dapagliflozin 10 mg once daily added to metformin
56585|NCT02229396|O1|Outcome|Dapagliflozin + Placebo|Dapagliflozin 10 mg once daily + Placebo 2 mg 1 time per week added to metformin
56586|NCT02229396|O3|Outcome|Exenatide + Placebo|Exenatide 2 mg 1 time per week + Placebo 10 mg once daily added to metformin
56587|NCT02229396|O2|Outcome|Exenatide + Dapagliflozin|Exenatide 2 mg 1 time per week + Dapagliflozin 10 mg once daily added to metformin
56588|NCT02229396|O1|Outcome|Dapagliflozin + Placebo|Dapagliflozin 10 mg once daily + Placebo 2 mg 1 time per week added to metformin
56589|NCT02229396|O3|Outcome|Exenatide + Placebo|Exenatide 2 mg 1 time per week + Placebo 10 mg once daily added to metformin
56590|NCT02229396|O2|Outcome|Exenatide + Dapagliflozin|Exenatide 2 mg 1 time per week + Dapagliflozin 10 mg once daily added to metformin
56591|NCT02229396|O1|Outcome|Dapagliflozin + Placebo|Dapagliflozin 10 mg once daily + Placebo 2 mg 1 time per week added to metformin
56592|NCT02229396|O3|Outcome|Exenatide + Placebo|Exenatide 2 mg 1 time per week + Placebo 10 mg once daily added to metformin
56593|NCT02229396|O2|Outcome|Exenatide + Dapagliflozin|Exenatide 2 mg 1 time per week + Dapagliflozin 10 mg once daily added to metformin
56594|NCT02229396|O1|Outcome|Dapagliflozin + Placebo|Dapagliflozin 10 mg once daily + Placebo 2 mg 1 time per week added to metformin
56595|NCT02229396|O3|Outcome|Exenatide + Placebo|Exenatide 2 mg 1 time per week + Placebo 10 mg once daily added to metformin
56596|NCT02229396|O2|Outcome|Exenatide + Dapagliflozin|Exenatide 2 mg 1 time per week + Dapagliflozin 10 mg once daily added to metformin
56597|NCT02229396|O1|Outcome|Dapagliflozin + Placebo|Dapagliflozin 10 mg once daily + Placebo 2 mg 1 time per week added to metformin
56598|NCT02229396|O3|Outcome|Exenatide + Placebo|Exenatide 2 mg 1 time per week + Placebo 10 mg once daily added to metformin
56599|NCT02229396|O2|Outcome|Exenatide + Dapagliflozin|Exenatide 2 mg 1 time per week + Dapagliflozin 10 mg once daily added to metformin
56600|NCT02229396|O1|Outcome|Dapagliflozin + Placebo|Dapagliflozin 10 mg once daily + Placebo 2 mg 1 time per week added to metformin
56601|NCT02229396|O3|Outcome|Exenatide + Placebo|Exenatide 2 mg 1 time per week + Placebo 10 mg once daily added to metformin
56602|NCT02229396|O2|Outcome|Exenatide + Dapagliflozin|Exenatide 2 mg 1 time per week + Dapagliflozin 10 mg once daily added to metformin
56603|NCT02229396|O1|Outcome|Dapagliflozin + Placebo|Dapagliflozin 10 mg once daily + Placebo 2 mg 1 time per week added to metformin
56604|NCT02229396|E3|Reported Event|Exenatide + Placebo|Exenatide 2 mg 1 time per week + Placebo 10 mg once daily added to metformin
56605|NCT02229396|E2|Reported Event|Exenatide + Dapagliflozin|Exenatide 2 mg 1 time per week + Dapagliflozin 10 mg once daily added to metformin
56606|NCT02229396|E1|Reported Event|Dapagliflozin + Placebo|Dapagliflozin 10 mg once daily + Placebo 2 mg 1 time per week added to metformin
56607|NCT02229383|B3|Baseline|Total|Total of all reporting groups
56608|NCT02229383|B2|Baseline|Placebo|Placebo 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
56609|NCT02229383|B1|Baseline|Exenatide|Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
56610|NCT02229383|P2|Participant Flow|Placebo|Placebo 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
56611|NCT02229383|P1|Participant Flow|Exenatide|Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
56612|NCT02229383|O2|Outcome|Placebo|Placebo 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
56613|NCT02229383|O1|Outcome|Exenatide|Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
56614|NCT02229383|O2|Outcome|Placebo|Placebo 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
56615|NCT02229383|O1|Outcome|Exenatide|Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
56616|NCT02229383|O2|Outcome|Placebo|Placebo 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
56617|NCT02229383|O1|Outcome|Exenatide|Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
56618|NCT02229383|O2|Outcome|Placebo|Placebo 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
56619|NCT02229383|O1|Outcome|Exenatide|Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
56620|NCT02229383|O2|Outcome|Placebo|Placebo 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
56621|NCT02229383|O1|Outcome|Exenatide|Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
56622|NCT02229383|O2|Outcome|Placebo|Placebo 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
56623|NCT02229383|O1|Outcome|Exenatide|Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
56624|NCT02229383|O2|Outcome|Placebo|Placebo 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
56625|NCT02229383|O1|Outcome|Exenatide|Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
56626|NCT02229383|E2|Reported Event|Placebo|Placebo 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
56627|NCT02229383|E1|Reported Event|Exenatide|Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
56628|NCT02229318|B1|Baseline|FruitiVits|Daily administration of FruitiVits dietary supplement
56629|NCT02229318|P1|Participant Flow|FruitiVits|Daily administration of FruitiVits dietary supplement
100996|NCT01970878|O3|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
56635|NCT02229214|B1|Baseline|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
56636|NCT02229214|P2|Participant Flow|Placebo|"Days 1-28: Placebo~Sugar Pill"
56637|NCT02229214|P1|Participant Flow|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
56638|NCT02229214|O2|Outcome|Placebo|"Days 1-28: Placebo~Placebo (sugar pill)"
56639|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
56640|NCT02229214|O2|Outcome|Placebo|"Days 1-28: Placebo~Placebo (sugar pill)"
56641|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
56642|NCT02229214|O2|Outcome|Placebo|"Days 1-28: Placebo~Sugar Pill"
56643|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
56644|NCT02229214|O2|Outcome|Sugar Pill|"Days 1-28: Placebo~Placebo"
56645|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
56646|NCT02229214|O2|Outcome|Placebo|"Days 1-28: Placebo~Sugar Pill"
56647|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
56648|NCT02229214|O2|Outcome|Sugar Pill|"Days 1-28: Placebo~Placebo"
56649|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
56650|NCT02229214|O2|Outcome|Sugar Pill|"Days 1-28: Placebo~Placebo"
56651|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
56652|NCT02229214|O2|Outcome|Placebo|"Days 1-28: Placebo~Sugar Pill"
56653|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
56654|NCT02229214|E2|Reported Event|Placebo|"Days 1-28: Placebo~Sugar Pill"
56655|NCT02229214|E1|Reported Event|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
56656|NCT02228980|B5|Baseline|Total|Total of all reporting groups
56657|NCT02228980|B4|Baseline|Age ≥61 Years Group|Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
56658|NCT02228980|B3|Baseline|Age 18 to 60 Years Group|Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
56659|NCT02228980|B2|Baseline|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
56660|NCT02228980|B1|Baseline|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
56661|NCT02228980|P4|Participant Flow|Age ≥61 Years Group|Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
56662|NCT02228980|P3|Participant Flow|Age 18 to 60 Years Group|Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
56663|NCT02228980|P2|Participant Flow|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
56664|NCT02228980|P1|Participant Flow|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
56665|NCT02228980|O4|Outcome|Age ≥61 Years Group|Participants ≥61 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
56666|NCT02228980|O3|Outcome|Age 18 to 60 Years Group|Participants 18 to 60 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
56667|NCT02228980|O2|Outcome|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
56668|NCT02228980|O1|Outcome|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
56669|NCT02228980|O4|Outcome|Age ≥61 Years Group|Participants ≥61 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
56670|NCT02228980|O3|Outcome|Age 18 to 60 Years Group|Participants 18 to 60 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
56671|NCT02228980|O2|Outcome|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
56672|NCT02228980|O1|Outcome|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
56979|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
56673|NCT02228980|O4|Outcome|Age ≥61 Years Group|Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
56674|NCT02228980|O3|Outcome|Age 8 to 60 Years Group|Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
56675|NCT02228980|O2|Outcome|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
56676|NCT02228980|O1|Outcome|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
56677|NCT02228980|O4|Outcome|Age ≥61 Years Group|Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
56678|NCT02228980|O3|Outcome|Age 8 to 60 Years Group|Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
56679|NCT02228980|O2|Outcome|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
56680|NCT02228980|O1|Outcome|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
56681|NCT02228980|E4|Reported Event|Group 4|Participants ≥61 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
56682|NCT02228980|E3|Reported Event|Group 3|Participants 18 to 60 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
56683|NCT02228980|E2|Reported Event|Group 2|Participants 3 to 17 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
56684|NCT02228980|E1|Reported Event|Group 1|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
56685|NCT02228720|B1|Baseline|Propel Nova Sinus Implant|Steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days
56686|NCT02228720|P1|Participant Flow|Propel Nova Sinus Implant|"Sinus stent with steroid coating (370 ug mometasone furoate)~Propel Nova Sinus Implant: Sinus stent with steroid coating (370 ug mometasone furoate)"
56687|NCT02228720|O1|Outcome|Propel Nova Sinus Implant|Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
56688|NCT02228720|O1|Outcome|Propel Nova Sinus Implant|Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
56689|NCT02228720|O1|Outcome|Propel Nova Sinus Implant|Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
56690|NCT02228720|O1|Outcome|Propel Nova Sinus Implant|Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
56691|NCT02228720|O1|Outcome|Propel Nova Sinus Implant|Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
56692|NCT02228720|E1|Reported Event|Propel Nova Sinus Implant|Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
56693|NCT02228395|B1|Baseline|All Participants|Included all participants who received at least 1 dose of study treatment in any of the intervention periods
56694|NCT02228395|P3|Participant Flow|PF-04958242 0.35 mg, PF-04958242 0.6 mg, Placebo|Participants received 1 single dose of PF-04958242 0.35 mg, PF-04958242 0.6 mg, and placebo orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing.
56695|NCT02228395|P2|Participant Flow|PF-04958242 0.35 mg, Placebo, PF-04958242 0.8 mg|Participants received 1 single dose of PF-04958242 0.35 mg, placebo, and PF-04958242 0.8 mg orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing.
56696|NCT02228395|P1|Participant Flow|Placebo, PF-04958242 0.6 Milligrams (mg), PF-04958242 0.8 mg|Participants received 1 single dose of placebo, PF-04958242 0.6 mg, and PF-04958242 0.8 mg orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing.
56697|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
56698|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
56699|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
56700|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
56701|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
56702|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
56703|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
56704|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
56705|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
56706|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
56707|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
56708|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
56709|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
56710|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
56980|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
56711|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
56712|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
56713|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
56714|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
56715|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
56716|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
56717|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
56718|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
56719|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
56720|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
56721|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
56722|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
56723|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
56724|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
56725|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
56726|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
56727|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
56728|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
56729|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
56730|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
56731|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
56732|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
56733|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
56734|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
56735|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
56736|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
56737|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
56738|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
56739|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
56740|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
56741|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
56742|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
56743|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
56744|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
56745|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
56746|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
56747|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
56748|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
56749|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
56750|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
56751|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
56752|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
56753|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
56754|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
56755|NCT02228395|E4|Reported Event|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
56756|NCT02228395|E3|Reported Event|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
56757|NCT02228395|E2|Reported Event|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
56758|NCT02228395|E1|Reported Event|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
56759|NCT02227810|B3|Baseline|Total|Total of all reporting groups
56760|NCT02227810|B2|Baseline|Sham Group|"Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.~sham group: Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off."
56761|NCT02227810|B1|Baseline|Electrical Stimulation|"Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days~electrical stimulation (high frequency): Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days~electrical stimulation (low frequency): Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days."
56762|NCT02227810|P2|Participant Flow|Electrical Stimulation|"Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days~electrical stimulation (high frequency): Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days~electrical stimulation (low frequency): Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days."
56763|NCT02227810|P1|Participant Flow|Sham Group|"Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.~sham group: Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off."
56764|NCT02227810|O2|Outcome|Electrical Stimulation|"Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days~electrical stimulation (high frequency): Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days~electrical stimulation (low frequency): Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days."
56765|NCT02227810|O1|Outcome|Sham Group|"Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.~sham group: Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off."
56766|NCT02227810|O2|Outcome|Electrical Stimulation|Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days
56767|NCT02227810|O1|Outcome|Sham Group|Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.
56768|NCT02227810|O2|Outcome|Electrical Stimulation|"Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days~electrical stimulation (high frequency): Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days~electrical stimulation (low frequency): Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days."
56769|NCT02227810|O1|Outcome|Sham Group|"Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.~sham group: Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off."
56770|NCT02227810|O2|Outcome|Electrical Stimulation|"Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days~electrical stimulation (high frequency): Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days~electrical stimulation (low frequency): Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days."
56771|NCT02227810|O1|Outcome|Sham Group|"Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.~sham group: Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off."
56772|NCT02227810|E2|Reported Event|Electrical Stimulation|Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days
56773|NCT02227810|E1|Reported Event|Sham Group|Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.
56774|NCT02227784|B5|Baseline|Total|Total of all reporting groups
56775|NCT02227784|B4|Baseline|Atorvastatin + Ezetimibe|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56776|NCT02227784|B3|Baseline|Atorvastatin 80 mg|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56777|NCT02227784|B2|Baseline|Atorvastatin 40 mg|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56801|NCT02227784|O3|Outcome|Atorvastatin 80 mg|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56778|NCT02227784|B1|Baseline|Atorvastatin + Evacetrapib|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56779|NCT02227784|P5|Participant Flow|Atorvastatin + Evacetrapib Open-Label (OLE)|Open label extension (OLE) (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56780|NCT02227784|P4|Participant Flow|Atorvastatin + Ezetimibe|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56781|NCT02227784|P3|Participant Flow|Atorvastatin 80 mg|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56782|NCT02227784|P2|Participant Flow|Atorvastatin 40 mg|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56783|NCT02227784|P1|Participant Flow|Atorvastatin + Evacetrapib|Atorvastatin 40 milligrams (mg) orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56784|NCT02227784|O4|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56785|NCT02227784|O3|Outcome|Atorvastatin 80 mg|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56786|NCT02227784|O2|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56787|NCT02227784|O1|Outcome|Atorvastatin + Evacetrapib|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56788|NCT02227784|O4|Outcome|Atorvastatin 80 mg|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56789|NCT02227784|O3|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56790|NCT02227784|O2|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56791|NCT02227784|O1|Outcome|Atorvastatin + Evacetrapib|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56792|NCT02227784|O4|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56793|NCT02227784|O3|Outcome|Atorvastatin 80 mg|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56794|NCT02227784|O2|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56795|NCT02227784|O1|Outcome|Atorvastatin + Evacetrapib|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56796|NCT02227784|O4|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56797|NCT02227784|O3|Outcome|Atorvastatin 80 mg|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56798|NCT02227784|O2|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56799|NCT02227784|O1|Outcome|Atorvastatin + Evacetrapib|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56800|NCT02227784|O4|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56802|NCT02227784|O2|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56803|NCT02227784|O1|Outcome|Atorvastatin + Evacetrapib|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56804|NCT02227784|O4|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56805|NCT02227784|O3|Outcome|Atorvastatin 80 mg|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56806|NCT02227784|O2|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56807|NCT02227784|O1|Outcome|Atorvastatin + Evacetrapib|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56808|NCT02227784|O4|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56809|NCT02227784|O3|Outcome|Atorvastatin 80 mg|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56810|NCT02227784|O2|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56811|NCT02227784|O1|Outcome|Atorvastatin + Evacetrapib|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56812|NCT02227784|E5|Reported Event|Atorvastatin + Evacetrapib Open-Label (OLE)|Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56813|NCT02227784|E4|Reported Event|Atorvastatin + Ezetimibe DB|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56814|NCT02227784|E3|Reported Event|Atorvastatin 80 mg DB|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56815|NCT02227784|E2|Reported Event|Atorvastatin 40 mg DB|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56816|NCT02227784|E1|Reported Event|Atorvastatin + Evacetrapib Double-Blind (DB)|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
56817|NCT02227485|B3|Baseline|Total|Total of all reporting groups
56818|NCT02227485|B2|Baseline|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patients in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
56819|NCT02227485|B1|Baseline|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patients in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
56820|NCT02227485|P2|Participant Flow|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
56821|NCT02227485|P1|Participant Flow|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
56822|NCT02227485|O2|Outcome|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
56823|NCT02227485|O1|Outcome|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
56824|NCT02227485|O2|Outcome|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
56825|NCT02227485|O1|Outcome|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
56826|NCT02227485|O2|Outcome|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
56827|NCT02227485|O1|Outcome|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
56828|NCT02227485|O2|Outcome|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
56829|NCT02227485|O1|Outcome|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
56830|NCT02227485|O2|Outcome|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
56831|NCT02227485|O1|Outcome|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
56832|NCT02227485|O2|Outcome|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
56833|NCT02227485|O1|Outcome|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
56834|NCT02227485|E2|Reported Event|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
56835|NCT02227485|E1|Reported Event|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
56836|NCT02227368|B3|Baseline|Total|Total of all reporting groups
56837|NCT02227368|B2|Baseline|Aspirin|Aspirin 100mg once daily plus ticagrelor placebo twice a day
56838|NCT02227368|B1|Baseline|Ticagrelor|Ticagrelor 90mg twice a day plus aspirin placebo once daily
56839|NCT02227368|P2|Participant Flow|Aspirin|Aspirin 100mg once daily plus ticagrelor placebo twice a day
56840|NCT02227368|P1|Participant Flow|Ticagrelor|Ticagrelor 90mg twice a day plus aspirin placebo once daily
56841|NCT02227368|O2|Outcome|Aspirin|Aspirin 100mg once daily plus ticagrelor placebo twice a day
56842|NCT02227368|O1|Outcome|Ticagrelor|Ticagrelor 90mg twice a day plus aspirin placebo once daily
56843|NCT02227368|O2|Outcome|Aspirin|Aspirin 100mg once daily plus ticagrelor placebo twice a day
56844|NCT02227368|O1|Outcome|Ticagrelor|Ticagrelor 90mg twice a day plus aspirin placebo once daily
56845|NCT02227368|E2|Reported Event|Aspirin|Aspirin 100mg once daily plus ticagrelor placebo twice a day
56846|NCT02227368|E1|Reported Event|Ticagrelor|Ticagrelor 90mg twice a day plus aspirin placebo once daily
56847|NCT02227329|B3|Baseline|Total|Total of all reporting groups
56848|NCT02227329|B2|Baseline|Heparin and Normal Saline|All patients randomized to this group will receive Heparin lock (3 mL of 100 U/ml heparin) + saline infusion (current standard of care).
56849|NCT02227329|B1|Baseline|Ethanol Lock and Normal Saline|All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.
56850|NCT02227329|P2|Participant Flow|Heparin and Normal Saline|All patients randomized to this group will receive Heparin lock (3 mL of 100 U/ml heparin) + saline infusion (current standard of care).
56851|NCT02227329|P1|Participant Flow|Ethanol Lock and Normal Saline|All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.
56852|NCT02227329|O2|Outcome|Heparin and Normal Saline|All patients randomized to this group will receive Heparin lock (3 mL of 100 U/ml heparin) + saline infusion (current standard of care).
56853|NCT02227329|O1|Outcome|Ethanol Lock and Normal Saline|All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.
56854|NCT02227329|E2|Reported Event|Heparin and Normal Saline|All patients randomized to this group will receive Heparin lock (3 mL of 100 U/ml heparin) + saline infusion (current standard of care).
56855|NCT02227329|E1|Reported Event|Ethanol Lock and Normal Saline|All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.
56856|NCT02227121|B1|Baseline|Enrolled Subjects|All subjects consented for the study.
56857|NCT02227121|P1|Participant Flow|Enrolled Subjects|All subjects consented for the study.
56858|NCT02227121|O1|Outcome|VF Induction and Defibrillation|"Ventricular Fibrillation (VF) induction and defibrillation will be carried out as the invention in all subjects undergoing study procedures.~Defibrillation following induction of VF: Up to 10 VF induction attempts followed by shock(s) delivered by an externally placed Implantable Cardioverter/Defibrillator (ICD) and/or external defibrillator."
56859|NCT02227121|E1|Reported Event|Enrolled Subjects|All subjects consented into the study
56860|NCT02227108|B1|Baseline|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56861|NCT02227108|P1|Participant Flow|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56862|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56863|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56864|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56865|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56866|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56867|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56868|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56869|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56870|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56871|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56872|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56873|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56874|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56875|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56876|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56877|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56878|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56978|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
56879|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56880|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56881|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56882|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56883|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56884|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56885|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56886|NCT02227108|E1|Reported Event|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
56887|NCT02226562|B3|Baseline|Total|Total of all reporting groups
56888|NCT02226562|B2|Baseline|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
56889|NCT02226562|B1|Baseline|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
56890|NCT02226562|P2|Participant Flow|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
56891|NCT02226562|P1|Participant Flow|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
56892|NCT02226562|O2|Outcome|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
56893|NCT02226562|O1|Outcome|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
56894|NCT02226562|O2|Outcome|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
56895|NCT02226562|O1|Outcome|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
56896|NCT02226562|O2|Outcome|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
56897|NCT02226562|O1|Outcome|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
56898|NCT02226562|O2|Outcome|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
56899|NCT02226562|O1|Outcome|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
56900|NCT02226562|O2|Outcome|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
56901|NCT02226562|O1|Outcome|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
56902|NCT02226562|O2|Outcome|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
56903|NCT02226562|O1|Outcome|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
56904|NCT02226562|E2|Reported Event|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
56905|NCT02226562|E1|Reported Event|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
56906|NCT02226549|B3|Baseline|Total|Total of all reporting groups
56907|NCT02226549|B2|Baseline|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
56908|NCT02226549|B1|Baseline|LDV/SOF+VDV|LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
56909|NCT02226549|P2|Participant Flow|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 8 weeks
56910|NCT02226549|P1|Participant Flow|LDV/SOF+VDV|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet + vedroprevir (VDV) 80 mg tablet once daily for 8 weeks
56911|NCT02226549|O2|Outcome|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
56912|NCT02226549|O1|Outcome|LDV/SOF+VDV|LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
56913|NCT02226549|O2|Outcome|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
56914|NCT02226549|O1|Outcome|LDV/SOF+VDV|LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
56915|NCT02226549|O2|Outcome|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
56916|NCT02226549|O1|Outcome|LDV/SOF+VDV|LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
56917|NCT02226549|E2|Reported Event|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
56918|NCT02226549|E1|Reported Event|LDV/SOF+VDV|LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
56919|NCT02226198|B1|Baseline|Cross-over|Cross-over phase
56920|NCT02226198|P3|Participant Flow|Placebo First Then Rosuva|Relevant for the cross-over phase
56921|NCT02226198|P2|Participant Flow|Rosuva First Then Placebo|Relevant for the cross-over phase
56922|NCT02226198|P1|Participant Flow|Overall|Relevant for the lead-in and maintenance phases
56923|NCT02226198|O1|Outcome|Safety Analysis Set|Safety Analysis Set
56924|NCT02226198|O2|Outcome|Pla/Ros|Safety Analysis Set, starting crossover-phase with 6 weeks of placebo
56925|NCT02226198|O1|Outcome|Ros/Pla|Safety Analysis Set, starting crossover-phase with 6 weeks of rosuvastatin
56926|NCT02226198|O3|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
56927|NCT02226198|O2|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
56928|NCT02226198|O1|Outcome|Safety Analysis Set|Safety Analysis Set
56929|NCT02226198|O2|Outcome|Pla/Ros|Safety Analysis Set, starting crossover-phase with 6 weeks of placebo
56930|NCT02226198|O1|Outcome|Ros/Pla|Safety Analysis Set, starting crossover-phase with 6 weeks of rosuvastatin
56931|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
56932|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
56933|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
56934|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
56935|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
56936|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
56937|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
56938|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
56939|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
56940|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
56941|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
56942|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
56943|NCT02226198|O2|Outcome|Pla/Ros|Safety Analysis Set, starting crossover-phase with 6 weeks of placebo
56944|NCT02226198|O1|Outcome|Ros/Pla|Safety Analysis Set, starting cross-over with 6 weeks of rosuvastatin
56945|NCT02226198|O2|Outcome|Pla/Ros|Safety Analysis Set, starting crossover-phase with 6 weeks of placebo
56946|NCT02226198|O1|Outcome|Ros/Pla|Safety Analysis Set, starting cross-over with 6 weeks of rosuvastatin
56947|NCT02226198|O2|Outcome|Pla/Ros|Safety Analysis Set, starting crossover-phase with 6 weeks of placebo
56948|NCT02226198|O1|Outcome|Ros/Pla|Safety Analysis Set, starting cross-over with 6 weeks of rosuvastatin
56949|NCT02226198|O2|Outcome|Pla/Ros|Safety Analysis Set, starting crossover-phase with 6 weeks of placebo
56950|NCT02226198|O1|Outcome|Ros/Pla|Safety Analysis Set, starting cross-over with 6 weeks of rosuvastatin
56951|NCT02226198|O4|Outcome|Pla/Ros >ULN|Safety Analysis Set, starting cross-over phase with 6 weeks of placebo
56952|NCT02226198|O3|Outcome|Pla/Ros <LLN|Safety Analysis Set, starting cross-over phase with 6 weeks of placebo
56953|NCT02226198|O2|Outcome|Ros/Pla >ULN|Safety Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin
56954|NCT02226198|O1|Outcome|Ros/Pla <LLN|Safety Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin
56955|NCT02226198|O3|Outcome|Maintenance Phase|Maintenance phase, Safety analysis set
56956|NCT02226198|O2|Outcome|Cross-over Phase|Cross-over phase, Safety analysis set
56957|NCT02226198|O1|Outcome|Lead-in|Optional 10mg lead-in phase, Safety analysis set
56958|NCT02226198|O3|Outcome|Maintenance|Maintenance Phase, Safety analysis set
56959|NCT02226198|O2|Outcome|Cross-over Phase|Cross-over phase, Safety analysis set
56960|NCT02226198|O1|Outcome|Lead-in|Optional 10mg lead-in phase, Safety analysis set
56961|NCT02226198|O2|Outcome|Maintenance Phase|Measurement taken after 6 weeks active treatment (rosuvastatin) in the maintenance phase.
56962|NCT02226198|O1|Outcome|Cross-over Phase|Measurements taken after 6 weeks active treatment (rosuvastatin) in the cross-over phase
56963|NCT02226198|O2|Outcome|M-FAS Placebo|Maintenance Full Analysis Set, starting cross-over phase with 6 weeks of placebo
56964|NCT02226198|O1|Outcome|M-FAS Rosuvastatin|Maintenance Full Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin
56965|NCT02226198|O2|Outcome|M-FAS Placebo|Maintenance Full Analysis Set, starting cross-over phase with 6 weeks of placebo
56966|NCT02226198|O1|Outcome|M-FAS Rosuvastatin|Maintenance Full Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin
56967|NCT02226198|O2|Outcome|C-FAS Placebo Not on Apheresis|Cross-over Full Analysis Set, 6 weeks of Placebo
56968|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
56969|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
56970|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
56971|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
56972|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
56973|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
56974|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
56975|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
56976|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
56977|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
56981|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
56982|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
56983|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
56984|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
56985|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
56986|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
56987|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
56988|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
56989|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
56990|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
56991|NCT02226198|E3|Reported Event|Maintenance|Maintenance phase
56992|NCT02226198|E2|Reported Event|Cross-over|Cross-over phase
56993|NCT02226198|E1|Reported Event|Lead-in|Lead-in
56994|NCT02226172|B1|Baseline|Glasdegib Lead-in|Glasdegib administered orally at a daily starting dose of 100 mg on a continuous regimen of 28-day cycles.
56995|NCT02226172|P1|Participant Flow|Glasdegib Lead-in|Glasdegib administered orally at a daily starting dose of 100 mg on a continuous regimen of 28-day cycles.
56996|NCT02226172|O1|Outcome|Glasdegib Lead-in|Glasdegib administered orally at a daily starting dose of 100 mg on a continuous regimen of 28-day cycles.
56997|NCT02226172|O1|Outcome|Glasdegib Lead-in|Glasdegib administered orally at a daily starting dose of 100 mg on a continuous regimen of 28-day cycles.
56998|NCT02226172|O1|Outcome|Glasdegib Lead-in|Glasdegib administered orally at a daily starting dose of 100 mg on a continuous regimen of 28-day cycles.
56999|NCT02226172|O1|Outcome|Glasdegib Lead-in|Glasdegib administered orally at a daily starting dose of 100 mg on a continuous regimen of 28-day cycles.
57000|NCT02226172|O1|Outcome|Glasdegib Lead-in|Glasdegib administered orally at a daily starting dose of 100 mg on a continuous regimen of 28-day cycles.
57001|NCT02226172|O1|Outcome|Glasdegib Lead-in|Glasdegib administered orally at a daily starting dose of 100 mg on a continuous regimen of 28-day cycles.
57002|NCT02226172|O1|Outcome|Glasdegib Lead-in|Glasdegib administered orally at a daily starting dose of 100 mg on a continuous regimen of 28-day cycles.
57003|NCT02226172|O1|Outcome|Glasdegib Lead-in|Glasdegib administered orally at a daily starting dose of 100 mg on a continuous regimen of 28-day cycles.
57004|NCT02226172|O1|Outcome|Glasdegib Lead-in|Glasdegib administered orally at a daily starting dose of 100 mg on a continuous regimen of 28-day cycles.
57005|NCT02226172|O1|Outcome|Glasdegib Lead-in|Glasdegib administered orally at a daily starting dose of 100 mg on a continuous regimen of 28-day cycles.
57006|NCT02226172|O1|Outcome|Glasdegib Lead-in|Glasdegib administered orally at a daily starting dose of 100 mg on a continuous regimen of 28-day cycles.
57007|NCT02226172|O1|Outcome|Glasdegib Lead-in|Glasdegib administered orally at a daily starting dose of 100 mg on a continuous regimen of 28-day cycles.
57008|NCT02226172|O1|Outcome|Glasdegib Lead-in|Glasdegib administered orally at a daily starting dose of 100 mg on a continuous regimen of 28-day cycles.
57009|NCT02226172|O1|Outcome|Glasdegib Lead-in|Glasdegib administered orally at a daily starting dose of 100 mg on a continuous regimen of 28-day cycles.
57010|NCT02226172|O1|Outcome|Glasdegib Lead-in|Glasdegib administered orally at a daily starting dose of 100 mg on a continuous regimen of 28-day cycles.
57011|NCT02226172|O1|Outcome|Glasdegib Lead-in|Glasdegib administered orally at a daily starting dose of 100 mg on a continuous regimen of 28-day cycles.
57012|NCT02226172|E1|Reported Event|Glasdegib Lead-in|Glasdegib administered orally at a daily starting dose of 100 mg on a continuous regimen of 28-day cycles.
57013|NCT02226003|B4|Baseline|Total|Total of all reporting groups
57014|NCT02226003|B3|Baseline|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
57015|NCT02226003|B2|Baseline|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
57016|NCT02226003|B1|Baseline|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
57017|NCT02226003|P3|Participant Flow|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
57018|NCT02226003|P2|Participant Flow|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
57019|NCT02226003|P1|Participant Flow|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
57020|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
57021|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
57022|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
57023|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
57024|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
57059|NCT02225860|O2|Outcome|Control|Continue with usual diet
100997|NCT01970878|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg
57025|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
57026|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
57027|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
57028|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
57029|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
57030|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
57031|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
57032|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
57033|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
57034|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
57035|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
57036|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
57037|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
57038|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
57039|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
57040|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
57041|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
57042|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
57043|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
57044|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
57045|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
57046|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
57047|NCT02226003|E3|Reported Event|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
57048|NCT02226003|E2|Reported Event|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
57049|NCT02226003|E1|Reported Event|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
57050|NCT02225860|B3|Baseline|Total|Total of all reporting groups
57051|NCT02225860|B2|Baseline|Control|Continue with usual diet
57052|NCT02225860|B1|Baseline|Diet and Water Adjustment|"Reduction in dietary salt and protein intake~Diet and water adjustment"
57053|NCT02225860|P2|Participant Flow|Control|Continue with usual diet
57054|NCT02225860|P1|Participant Flow|Diet and Water Adjustment|"Reduction in dietary salt and protein intake~Diet and water adjustment"
57055|NCT02225860|O2|Outcome|Control|Continue with usual diet
57056|NCT02225860|O1|Outcome|Diet and Water Adjustment|"Reduction in dietary salt and protein intake~Diet and water adjustment: The dietary intervention consisted of three elements: low sodium (1500 mg/day), low protein (daily protein dietary allowance of 0.8 gram/kg body weight), and low urea (avoidance of preservatives, food additives, bulking agents, and chewing gum). Protein was factored by measured body weight to mirror the estimated average requirement (EAR) of healthy adults which is set on a grams per kilogram basis"
57057|NCT02225860|O2|Outcome|Control|Continue with usual diet
57058|NCT02225860|O1|Outcome|Diet and Water Adjustment|"Reduction in dietary salt and protein intake~Diet and water adjustment"
57060|NCT02225860|O1|Outcome|Diet and Water Adjustment|"Reduction in dietary salt and protein intake~Diet and water adjustment"
57061|NCT02225860|E2|Reported Event|Control|Continue with usual diet
57062|NCT02225860|E1|Reported Event|Diet and Water Adjustment|"Reduction in dietary salt and protein intake~Diet and water adjustment"
57063|NCT02224846|B3|Baseline|Total|Total of all reporting groups
57064|NCT02224846|B2|Baseline|5 mg Tadalafil|5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
57065|NCT02224846|B1|Baseline|2.5 mg Tadalafil|2.5 mg tadalafil orally once daily for 3 months (period 1) or 5 mg tadalafil orally once daily 21 months (Period 2).
57066|NCT02224846|P2|Participant Flow|5 mg Tadalafil|5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
57067|NCT02224846|P1|Participant Flow|2.5 mg Tadalafil|2.5 mg tadalafil orally once daily for 3 months (period 1) or 5 mg tadalafil orally once daily 21 months (Period 2).
57068|NCT02224846|O2|Outcome|5 mg Tadalafil|5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
57069|NCT02224846|O1|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil orally once daily for 3 months (period 1) or 5 mg tadalafil orally once daily 21 months (Period 2).
57070|NCT02224846|O2|Outcome|5 mg Tadalafil|5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
57071|NCT02224846|O1|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil orally once daily for 3 months (period 1) or 5 mg tadalafil orally once daily 21 months (Period 2).
57072|NCT02224846|O2|Outcome|5 mg Tadalafil|5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
57073|NCT02224846|O1|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil orally once daily for 3 months (period 1) or 5 mg tadalafil orally once daily 21 months (Period 2).
57074|NCT02224846|O2|Outcome|5 mg Tadalafil|5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
57075|NCT02224846|O1|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil orally once daily for 3 months (period 1) or 5 mg tadalafil orally once daily 21 months (Period 2).
57076|NCT02224846|O1|Outcome|5 mg Tadalafil|5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
57077|NCT02224846|O2|Outcome|5 mg Tadalafil|5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
57078|NCT02224846|O1|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil orally once daily for 3 months (period 1) or 5 mg tadalafil orally once daily 21 months (Period 2).
57079|NCT02224846|O2|Outcome|5 mg Tadalafil|5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
57080|NCT02224846|O1|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil orally once daily for 3 months (period 1) or 5 mg tadalafil orally once daily 21 months (Period 2).
57081|NCT02224846|E2|Reported Event|5 mg Tadalafil|5 mg tadalafil orally once daily for 21 or 24 months.
57082|NCT02224846|E1|Reported Event|2.5 mg Tadalafil|2.5 mg tadalafil orally once daily for 3 months.
57083|NCT02224820|B1|Baseline|Intravenous IdeS|"One or two doses of IdeS in ascending doses~IdeS"
57084|NCT02224820|P1|Participant Flow|Intravenous IdeS|One or two doses of IdeS in ascending doses.
57085|NCT02224820|O1|Outcome|Intravenous IdeS|One or two doses of IdeS in ascending doses.
57086|NCT02224820|O1|Outcome|Intravenous IdeS|One or two doses of IdeS in ascending doses.
57087|NCT02224820|O1|Outcome|Intravenous IdeS|One or two doses of IdeS in ascending doses.
57088|NCT02224820|O1|Outcome|Intravenous IdeS|One or two doses of IdeS in ascending doses.
57089|NCT02224820|O1|Outcome|Intravenous IdeS|One or two doses of IdeS in ascending doses.
57090|NCT02224820|E1|Reported Event|Intravenous IdeS|One or two doses of IdeS in ascending doses.
57091|NCT02224664|B1|Baseline|Overall Study|All participants who received a single oral dose of L-Dopa tablet/capsule (up to a maximum dose of 250 mg, based on investigator’s discretion) in lead-in period and/or single oral dose of PF-06649751 tablet (3 mg, 5 mg, 15 mg and 25 mg) in dose escalation period.
57092|NCT02224664|P5|Participant Flow|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
57093|NCT02224664|P4|Participant Flow|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
57094|NCT02224664|P3|Participant Flow|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
57095|NCT02224664|P2|Participant Flow|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
57096|NCT02224664|P1|Participant Flow|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
57097|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
57098|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
57099|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
57206|NCT02224053|P1|Participant Flow|AZD9291 and Omeprazole|Sequential treatments periods of AZD9291 + omeprazole (including a washout) followed by AZD9291 alone.
57100|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
57101|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
57102|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
57103|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
57104|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
57105|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
57106|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
57107|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
57108|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
57109|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
57110|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
57111|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
57112|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
57113|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
57114|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
57115|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
57116|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
57117|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
57118|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
57119|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
57120|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
57121|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
57207|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
57122|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
57123|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
57124|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
57125|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
57126|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
57127|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
57128|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
57129|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
57130|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
57131|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
57132|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
57133|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
57134|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
57135|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
57136|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
57137|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
57138|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
57139|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
57140|NCT02224664|O5|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
57141|NCT02224664|O4|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
57142|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
57143|NCT02224664|O2|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
57144|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
57208|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
100998|NCT01970878|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
57145|NCT02224664|O5|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
57146|NCT02224664|O4|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
57147|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
57148|NCT02224664|O2|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
57149|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
57150|NCT02224664|O5|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
57151|NCT02224664|O4|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
57152|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
57153|NCT02224664|O2|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
57154|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
57155|NCT02224664|O5|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
57156|NCT02224664|O4|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
57157|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
57158|NCT02224664|O2|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
57159|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
57160|NCT02224664|O5|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
57161|NCT02224664|O4|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
57162|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
57163|NCT02224664|O2|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
57164|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
57165|NCT02224664|O5|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
57166|NCT02224664|O4|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
57167|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
57168|NCT02224664|O2|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
57169|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
57170|NCT02224664|E5|Reported Event|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
57171|NCT02224664|E4|Reported Event|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
57172|NCT02224664|E3|Reported Event|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
57173|NCT02224664|E2|Reported Event|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
57174|NCT02224664|E1|Reported Event|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
57175|NCT02224625|B1|Baseline|2% CHG, Vehicle, DynaHex, Saline|Chlorhexidine Gluconate 2% Cloth Solution Vehicle solution of CHG cloth DynaHex 2% CHG solution 0.9% Saline Sodium Lauryl Sulfate (only used in Irritation Study)
57176|NCT02224625|P1|Participant Flow|2% CHG Cloth, Vehicle, DynaHex, Saline, SLS|Chlorhexidine Gluconate 2% cloth solution Vehicle solution of 2% CHG cloth DynaHex (2% CHG) 0.9% Saline Sodium Lauryl Sulfate
57177|NCT02224625|O5|Outcome|Sodium Lauryl Sulfate (SLS)|"Sodium lauryl sulfate to produce mild irritation as a positive control~SLS: Provides a slight irritation for a positive control"
57178|NCT02224625|O4|Outcome|Saline|"0.9% sodium chloride~Saline: Negative control"
57179|NCT02224625|O3|Outcome|DynaHex (2% CHG)|"Chlorhexidine Gluconate 2% solution~Active Comparator: 2% CHG solution"
57180|NCT02224625|O2|Outcome|Vehicle Cloth|"Excipients on cloth~Vehicle Cloth: Excipients from CHG cloth only"
57181|NCT02224625|O1|Outcome|2% CHG Cloth|"Chlorhexidine Gluconate 2%~2% CHG Cloth: CHG solution on cloth"
57182|NCT02224625|E5|Reported Event|Sodium Lauryl Sulfate (SLS)|"Sodium lauryl sulfate to produce mild irritation as a positive control~SLS: Provides a slight irritation for a positive control"
57183|NCT02224625|E4|Reported Event|Saline|"0.9% sodium chloride~Saline: Negative control"
57184|NCT02224625|E3|Reported Event|DynaHex (2% CHG)|"Chlorhexidine Gluconate 2% solution~Active Comparator: 2% CHG solution"
57185|NCT02224625|E2|Reported Event|Vehicle Cloth|"Excipients on cloth~Vehicle Cloth: Excipients from CHG cloth only"
57186|NCT02224625|E1|Reported Event|2% CHG Cloth|"Chlorhexidine Gluconate 2%~2% CHG Cloth: CHG solution on cloth"
57187|NCT02224508|B3|Baseline|Total|Total of all reporting groups
57188|NCT02224508|B2|Baseline|Usual Care|Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
57189|NCT02224508|B1|Baseline|Opioid Risk Reduction Initiative|Opioid risk reduction initiatives (dose reduction and then risk stratification and monitoring) for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.
57190|NCT02224508|P2|Participant Flow|Usual Care|Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
57191|NCT02224508|P1|Participant Flow|Opioid Risk Reduction Initiative|Opioid risk reduction initiative for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.
57192|NCT02224508|O2|Outcome|Usual Care|Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
57193|NCT02224508|O1|Outcome|Opioid Risk Reduction Initiative|Opioid risk reduction initiatives (dose reduction and then risk stratification and monitoring) for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.
57194|NCT02224508|O2|Outcome|Usual Care|Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
57195|NCT02224508|O1|Outcome|Opioid Risk Reduction Initiative|Opioid risk reduction initiative for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.
57196|NCT02224508|O2|Outcome|Usual Care|Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
57197|NCT02224508|O1|Outcome|Opioid Risk Reduction Initiative|Opioid risk reduction initiatives (dose reduction and then risk stratification and monitoring) for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.
57198|NCT02224508|E2|Reported Event|Usual Care|Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
57199|NCT02224508|E1|Reported Event|Opioid Risk Reduction Initiative|Opioid risk reduction initiatives (dose reduction and then risk stratification and monitoring) for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.
57200|NCT02224404|B1|Baseline|Fast Gelling Dressing|Fast Gelling Dressing (Exufiber)
57201|NCT02224404|P1|Participant Flow|Fast Gelling Dressing|Fast Gelling Dressing (Exufiber)
57202|NCT02224404|O1|Outcome|Fast Gelling Dressing|Fast Gelling Dressing (Exufiber)
57203|NCT02224404|O1|Outcome|Fast Gelling Dressing|Fast Gelling Dressing (Exufiber)
57204|NCT02224404|E1|Reported Event|Fast Gelling Dressing|Fast Gelling Dressing (Exufiber)
57205|NCT02224053|B1|Baseline|AZD9291 and Omeprazole|Sequential treatments periods of AZD9291 + omeprazole (including a washout) followed by AZD9291 alone.
57209|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
57210|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
57211|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
57212|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
57213|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
57214|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
57215|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
57216|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
57217|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
57218|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
57219|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
57220|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
57221|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
57222|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
57223|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
57224|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
57225|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
57226|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
57227|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
57228|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
57229|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
57230|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
57231|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
57232|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
57233|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
57234|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
57235|NCT02224053|E2|Reported Event|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
57236|NCT02224053|E1|Reported Event|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
57237|NCT02223871|B1|Baseline|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes occurred 16 days after ACT-451840 administration (or earlier if required).
57238|NCT02223871|P1|Participant Flow|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
57239|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
57240|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
57241|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
57242|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
57279|NCT02223650|B3|Baseline|Total|Total of all reporting groups
57280|NCT02223650|B2|Baseline|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
57243|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
57244|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
57245|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
57246|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
57247|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
57248|NCT02223871|E1|Reported Event|ACT-451840 500 mg|The eight subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes on Day 0 and received 500 mg of ACT-451840 on Day 7. All of them received six doses of Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, as per protocol.
57249|NCT02223754|B3|Baseline|Total|Total of all reporting groups
57250|NCT02223754|B2|Baseline|Lotrafilcon B / Etafilcon A|Subjects that were randomized to this sequence and were dispensed a study lens.
57251|NCT02223754|B1|Baseline|Etafilcon A / Lotrafilcon B|Subjects that were randomized to this sequence and were dispensed a study lens.
57252|NCT02223754|P2|Participant Flow|Lotrafilcon B/ Etafilcon A|Subjects were randomized to one of two lens sequences. Subjects first received the lotrafilcon B lens and then received the etafilcon A lens.
57253|NCT02223754|P1|Participant Flow|Etafilcon A / Lotrafilcon B|Subjects were randomized to one of two lens sequences. Subjects first received the etafilcon A contact lens and then received the Control lens (lotrafilcon B contact lens.
57254|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B during either the first or second period of the study.
57255|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
57256|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
57257|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
57258|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
57259|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
57260|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
57261|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
57262|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
57263|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
57264|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
57265|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
57266|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B during either the first or second period of the study.
57267|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
57268|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
57269|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
57270|NCT02223754|E2|Reported Event|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
57271|NCT02223754|E1|Reported Event|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
57272|NCT02223715|B1|Baseline|Clostridium Difficile Infection|Patient with Clostridium Difficile Infection
57273|NCT02223715|P1|Participant Flow|Clostridium Difficile Infection|To characterize the ｍanagement and outcome of Clostridium Difficile Infection in asian pacific countries
57274|NCT02223715|O1|Outcome|Recurrence or Not After 2 Months Follow-up|
57275|NCT02223715|O1|Outcome|Clinical Complication|
57276|NCT02223715|O1|Outcome|Status at the End of CDI Episode|To characterize the management and outcome of Clostridium Difficile Infection
57277|NCT02223715|O1|Outcome|Medical History|To characterize the management and outcome of Clostridium Difficile Infection
57278|NCT02223715|E1|Reported Event|Clostridium Difficile Infection|Patient with Clostridium Difficile Infection
57281|NCT02223650|B1|Baseline|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
57282|NCT02223650|P2|Participant Flow|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
57283|NCT02223650|P1|Participant Flow|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
57284|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
57285|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
57286|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
57287|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
57288|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
57289|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
57290|NCT02223650|O2|Outcome|Non-overminus Treatment|Spectacle-related questions at follow up apply only to non-overminus group participants prescribed correction spectacles.
57291|NCT02223650|O1|Outcome|Overminus Treatment|Spectacle-related questions at follow up apply to all overminus group participants.
57292|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
57293|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
57294|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
57295|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
57296|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
57297|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
57298|NCT02223650|O2|Outcome|Non-overminus Treatment|Spectacle-related questions at follow up apply only to non-overminus group participants prescribed correction spectacles.
57299|NCT02223650|O1|Outcome|Overminus Treatment|Spectacle-related questions at follow up apply to all overminus group participants.
57300|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
57301|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
57302|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
57303|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
57304|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
57305|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
57306|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
57307|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
57308|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
57309|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
57310|NCT02223650|E2|Reported Event|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
57311|NCT02223650|E1|Reported Event|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
57312|NCT02223429|B5|Baseline|Total|Total of all reporting groups
57313|NCT02223429|B4|Baseline|Placebo First, Followed by AVP|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered vasopressin spray in each nostril. Time between interventions was 2-10 days.
57314|NCT02223429|B3|Baseline|AVP First, Followed by Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered vasopressin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
57315|NCT02223429|B2|Baseline|Placebo First, Followed by OT|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
57316|NCT02223429|B1|Baseline|OT First, Followed by Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
57317|NCT02223429|P4|Participant Flow|Placebo First, Followed by AVP|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered vasopressin spray in each nostril. Time between interventions was 2-10 days.
57318|NCT02223429|P3|Participant Flow|AVP First, Followed by Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered vasopressin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
57319|NCT02223429|P2|Participant Flow|Placebo First, Followed by OT|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
103216|NCT01963845|O1|Outcome|Placebo|Sitagliptin-matched placebo tablet
57320|NCT02223429|P1|Participant Flow|OT First, Followed by Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
57321|NCT02223429|O2|Outcome|Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered vasopressin spray in each nostril. Time between interventions was 2-10 days.
57322|NCT02223429|O1|Outcome|Vasopressin (AVP)|Participants were randomized to receive no more than 1 ml solution of self-administered vasopressin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
57323|NCT02223429|O2|Outcome|Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
57324|NCT02223429|O1|Outcome|Oxytocin|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
57325|NCT02223429|O2|Outcome|Placebo|All participants who were administered placebo at any time point during the study and have completed the cry rating scale.
57326|NCT02223429|O1|Outcome|Vasopressin (AVP)|All participants who were administered AVP at any time point during the study and have completed the cry rating scale.
57327|NCT02223429|O2|Outcome|Placebo|All participants who were administered placebo at any time point during the study and have completed the cry rating scale.
57328|NCT02223429|O1|Outcome|Oxytocin|All participants who were administered oxytocin at any time point during the study and have completed the cry rating scale.
57329|NCT02223429|O1|Outcome|OT + Placebo Group|The OT + placebo group self-administered no more than 1 ml solution of oxytocin or placebo in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays. The order of administration of drug and placebo was counterbalanced across subjects, such that half received OT first, and half received OT second.
57330|NCT02223429|O1|Outcome|AVP + Placebo|The AVP + placebo group self-administered no more than 1 ml solution of vasopressin or placebo in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays. The order of administration of drug and placebo was counterbalanced across subjects, such that half received AVP first, and half received AVP second.
57331|NCT02223429|O2|Outcome|Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
57332|NCT02223429|O1|Outcome|Oxytocin|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
57333|NCT02223429|O2|Outcome|Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
57334|NCT02223429|O1|Outcome|Oxytocin|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
57335|NCT02223429|O2|Outcome|Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
57336|NCT02223429|O1|Outcome|Oxytocin|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
57337|NCT02223429|O2|Outcome|Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
57338|NCT02223429|O1|Outcome|Oxytocin|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
57339|NCT02223429|O2|Outcome|Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
57340|NCT02223429|O1|Outcome|Oxytocin|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
57341|NCT02223429|O2|Outcome|Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
57342|NCT02223429|O1|Outcome|Oxytocin|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
57343|NCT02223429|E4|Reported Event|Placebo of AVP|"The placebo of AVP group self-administered no more than 1 ml solution of placebo of AVP in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays.~This group also went through the AVP treatment."
57344|NCT02223429|E3|Reported Event|Placebo of OT|"The placebo of OT group self-administered no more than 1 ml solution of placebo of OT in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays.~This group also went through the OT treatment."
57345|NCT02223429|E2|Reported Event|AVP Treatment|"The AVP group self-administered no more than 1 ml solution of vasopressin in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays.~This group also went through the Placebo of AVP treatment."
58876|NCT02214121|O1|Outcome|Ticagrelor 0.125 mg/kg Bid|Repeated bid treatment during Part B.
57346|NCT02223429|E1|Reported Event|OT Treatment|"The OT group self-administered no more than 1 ml solution of oxytocin in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays.~This group also went through the Placebo of OT treatment."
57347|NCT02223364|B4|Baseline|Total|Total of all reporting groups
57348|NCT02223364|B3|Baseline|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57349|NCT02223364|B2|Baseline|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57350|NCT02223364|B1|Baseline|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
57351|NCT02223364|P3|Participant Flow|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57352|NCT02223364|P2|Participant Flow|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57353|NCT02223364|P1|Participant Flow|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
57354|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57355|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57356|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
57357|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57358|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57359|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
57360|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57361|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57362|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
57363|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57364|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57365|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
57366|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57367|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57368|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
57369|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57370|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57371|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
57372|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57373|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57374|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
57716|NCT02221648|E1|Reported Event|Placebo|Subjects will be randomized to receive injections with placebo.
103217|NCT01963845|O2|Outcome|Active Drug|"Sitagliptin 100 mg~Sitagliptin"
57375|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57376|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57377|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
57378|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57379|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57380|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
57381|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57382|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57383|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
57384|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57385|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57386|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
57387|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57428|NCT02223260|E1|Reported Event|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
57429|NCT02223065|B3|Baseline|Total|Total of all reporting groups
57388|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57389|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
57390|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57391|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57392|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
57393|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57394|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57395|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
57396|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57397|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57398|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
57399|NCT02223364|E3|Reported Event|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57400|NCT02223364|E2|Reported Event|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
57401|NCT02223364|E1|Reported Event|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
57402|NCT02223338|B3|Baseline|Total|Total of all reporting groups
57717|NCT02221557|B1|Baseline|New Alloplastic Bone Graft Material|easy-graft (beta-Tricalcium Phosphate)
57403|NCT02223338|B2|Baseline|Standard Aseptic Technique|"Standard Aseptic Technique:~Patients with choroidal neovascularization due to wet age-related macular degeneration or any other cause, clinically significant macular edema or cystoid macular edema over age 18 who have been treated with at least 3 monthly intravitreal injections of an anti-Vascular Endothelial Growth Factor (anti-VEGF) agent in the last 6 months. These injections must have been given with povidone-iodine only applied to the injection site and conjunctival fornix prior to injection, but no post-injection antibiotics were given. On the visit of their next injection, a conjunctival swab will be taken in the inferior fornix prior to instillation of any ophthalmic drops.~Standard Aseptic Technique: Patients in this group will have received Povidone-Iodine Only following injections of anti-VEGF agents at least 3 times in the last 6 months."
57404|NCT02223338|B1|Baseline|Ciprofloxacin|"Ciprofloxacin:~Patients with choroidal neovascularization due to wet age-related macular degeneration or any other cause, clinically significant macular edema or cystoid macular edema over age 18 who have been treated with at least 3 monthly intravitreal injections of an anti-Vascular Endothelial Growth Factor (anti-VEGF) agent in the last 6 months. These patients must have been instructed to use post-injection topical ciprofloxacin 0.3% 4x daily for 3 days. On the visit of their next injection, a conjunctival swab will be taken in the inferior fornix prior to instillation of any ophthalmic drops.~Ciprofloxacin: Use of topical ciprofloxacin 4x daily for 3 days after intravitreal injection using standard aseptic techniques with Povidone-Iodine is a common practice intervention in the United States, and is thought by some to reduce the risk of post-injection endophthalmitis."
57405|NCT02223338|P2|Participant Flow|Standard Aseptic Technique|"Standard Aseptic Technique:~Patients with choroidal neovascularization due to wet age-related macular degeneration or any other cause, clinically significant macular edema or cystoid macular edema over age 18 who have been treated with at least 3 monthly intravitreal injections of an anti-Vascular Endothelial Growth Factor (anti-VEGF) agent in the last 6 months. These injections must have been given with povidone-iodine only applied to the injection site and conjunctival fornix prior to injection, but no post-injection antibiotics were given. On the visit of their next injection, a conjunctival swab will be taken in the inferior fornix prior to instillation of any ophthalmic drops.~Standard Aseptic Technique: Patients in this group will have received Povidone-Iodine Only following injections of anti-VEGF agents at least 3 times in the last 6 months."
57406|NCT02223338|P1|Participant Flow|Ciprofloxacin|"Ciprofloxacin:~Patients with choroidal neovascularization due to wet age-related macular degeneration or any other cause, clinically significant macular edema or cystoid macular edema over age 18 who have been treated with at least 3 monthly intravitreal injections of an anti-Vascular Endothelial Growth Factor (anti-VEGF) agent in the last 6 months. These patients must have been instructed to use post-injection topical ciprofloxacin 0.3% 4x daily for 3 days. On the visit of their next injection, a conjunctival swab will be taken in the inferior fornix prior to instillation of any ophthalmic drops.~Ciprofloxacin: Use of topical ciprofloxacin 4x daily for 3 days after intravitreal injection using standard aseptic techniques with Povidone-Iodine is a common practice intervention in the United States, and is thought by some to reduce the risk of post-injection endophthalmitis."
57407|NCT02223338|O2|Outcome|Standard Aseptic Technique|"Standard Aseptic Technique:~Patients with choroidal neovascularization due to wet age-related macular degeneration or any other cause, clinically significant macular edema or cystoid macular edema over age 18 who have been treated with at least 3 monthly intravitreal injections of an anti-Vascular Endothelial Growth Factor (anti-VEGF) agent in the last 6 months. These injections must have been given with povidone-iodine only applied to the injection site and conjunctival fornix prior to injection, but no post-injection antibiotics were given. On the visit of their next injection, a conjunctival swab will be taken in the inferior fornix prior to instillation of any ophthalmic drops.~Standard Aseptic Technique: Patients in this group will have received Povidone-Iodine Only following injections of anti-VEGF agents at least 3 times in the last 6 months."
57408|NCT02223338|O1|Outcome|Ciprofloxacin|"Ciprofloxacin:~Patients with choroidal neovascularization due to wet age-related macular degeneration or any other cause, clinically significant macular edema or cystoid macular edema over age 18 who have been treated with at least 3 monthly intravitreal injections of an anti-Vascular Endothelial Growth Factor (anti-VEGF) agent in the last 6 months. These patients must have been instructed to use post-injection topical ciprofloxacin 0.3% 4x daily for 3 days. On the visit of their next injection, a conjunctival swab will be taken in the inferior fornix prior to instillation of any ophthalmic drops.~Ciprofloxacin: Use of topical ciprofloxacin 4x daily for 3 days after intravitreal injection using standard aseptic techniques with Povidone-Iodine is a common practice intervention in the United States, and is thought by some to reduce the risk of post-injection endophthalmitis."
57409|NCT02223338|O2|Outcome|Standard Aseptic Technique|"Standard Aseptic Technique:~Patients with choroidal neovascularization due to wet age-related macular degeneration or any other cause, clinically significant macular edema or cystoid macular edema over age 18 who have been treated with at least 3 monthly intravitreal injections of an anti-Vascular Endothelial Growth Factor (anti-VEGF) agent in the last 6 months. These injections must have been given with povidone-iodine only applied to the injection site and conjunctival fornix prior to injection, but no post-injection antibiotics were given. On the visit of their next injection, a conjunctival swab will be taken in the inferior fornix prior to instillation of any ophthalmic drops.~Standard Aseptic Technique: Patients in this group will have received Povidone-Iodine Only following injections of anti-VEGF agents at least 3 times in the last 6 months."
57410|NCT02223338|O1|Outcome|Ciprofloxacin|"Ciprofloxacin:~Patients with choroidal neovascularization due to wet age-related macular degeneration or any other cause, clinically significant macular edema or cystoid macular edema over age 18 who have been treated with at least 3 monthly intravitreal injections of an anti-Vascular Endothelial Growth Factor (anti-VEGF) agent in the last 6 months. These patients must have been instructed to use post-injection topical ciprofloxacin 0.3% 4x daily for 3 days. On the visit of their next injection, a conjunctival swab will be taken in the inferior fornix prior to instillation of any ophthalmic drops.~Ciprofloxacin: Use of topical ciprofloxacin 4x daily for 3 days after intravitreal injection using standard aseptic techniques with Povidone-Iodine is a common practice intervention in the United States, and is thought by some to reduce the risk of post-injection endophthalmitis."
57430|NCT02223065|B2|Baseline|Treatment BA|"Treatment B: Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.~Treatment A: Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions."
59316|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
57411|NCT02223338|E2|Reported Event|Standard Aseptic Technique|"Standard Aseptic Technique:~Patients with choroidal neovascularization due to wet age-related macular degeneration or any other cause, clinically significant macular edema or cystoid macular edema over age 18 who have been treated with at least 3 monthly intravitreal injections of an anti-Vascular Endothelial Growth Factor (anti-VEGF) agent in the last 6 months. These injections must have been given with povidone-iodine only applied to the injection site and conjunctival fornix prior to injection, but no post-injection antibiotics were given. On the visit of their next injection, a conjunctival swab will be taken in the inferior fornix prior to instillation of any ophthalmic drops.~Standard Aseptic Technique: Patients in this group will have received Povidone-Iodine Only following injections of anti-VEGF agents at least 3 times in the last 6 months."
57412|NCT02223338|E1|Reported Event|Ciprofloxacin|"Ciprofloxacin:~Patients with choroidal neovascularization due to wet age-related macular degeneration or any other cause, clinically significant macular edema or cystoid macular edema over age 18 who have been treated with at least 3 monthly intravitreal injections of an anti-Vascular Endothelial Growth Factor (anti-VEGF) agent in the last 6 months. These patients must have been instructed to use post-injection topical ciprofloxacin 0.3% 4x daily for 3 days. On the visit of their next injection, a conjunctival swab will be taken in the inferior fornix prior to instillation of any ophthalmic drops.~Ciprofloxacin: Use of topical ciprofloxacin 4x daily for 3 days after intravitreal injection using standard aseptic techniques with Povidone-Iodine is a common practice intervention in the United States, and is thought by some to reduce the risk of post-injection endophthalmitis."
57413|NCT02223260|B1|Baseline|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
57414|NCT02223260|P1|Participant Flow|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
57415|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
57416|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
57417|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
57418|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
57419|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
57420|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
57421|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
57422|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
57423|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
57424|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
57425|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
57426|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
57427|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
57431|NCT02223065|B1|Baseline|Treatment AB|"Treatment A: Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.~Treatment B: Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions."
57432|NCT02223065|P2|Participant Flow|Treatment BA|"Treatment B: Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.~Treatment A: Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions."
57433|NCT02223065|P1|Participant Flow|Treatment AB|"Treatment A: Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.~Treatment B: Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions."
57434|NCT02223065|O2|Outcome|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
57435|NCT02223065|O1|Outcome|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
57436|NCT02223065|O2|Outcome|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
57437|NCT02223065|O1|Outcome|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
57438|NCT02223065|O2|Outcome|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
57439|NCT02223065|O1|Outcome|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
57440|NCT02223065|O2|Outcome|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
57441|NCT02223065|O1|Outcome|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
57442|NCT02223065|O2|Outcome|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
57443|NCT02223065|O1|Outcome|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
57444|NCT02223065|O2|Outcome|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
57445|NCT02223065|O1|Outcome|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
57446|NCT02223065|E2|Reported Event|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
57447|NCT02223065|E1|Reported Event|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
57448|NCT02222870|B3|Baseline|Total|Total of all reporting groups
57449|NCT02222870|B2|Baseline|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
57450|NCT02222870|B1|Baseline|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
57451|NCT02222870|P2|Participant Flow|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
57452|NCT02222870|P1|Participant Flow|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
57453|NCT02222870|O2|Outcome|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
57454|NCT02222870|O1|Outcome|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
57455|NCT02222870|O2|Outcome|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
57456|NCT02222870|O1|Outcome|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
57457|NCT02222870|O2|Outcome|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
57458|NCT02222870|O1|Outcome|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
57459|NCT02222870|O2|Outcome|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
57460|NCT02222870|O1|Outcome|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
57461|NCT02222870|O2|Outcome|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
57462|NCT02222870|O1|Outcome|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
57463|NCT02222870|E2|Reported Event|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
57464|NCT02222870|E1|Reported Event|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
57465|NCT02222818|B3|Baseline|Total|Total of all reporting groups
57466|NCT02222818|B2|Baseline|Group B: CAFRPlus First|"Subjects randomized to Group B will receive CAFRPlus first, then cross over to CAFR.~Conducted AF Response (CAFR): The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.~Conducted AF Response Plus (CAFRPlus): The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing."
57467|NCT02222818|B1|Baseline|Group A: CAFR First|"Subjects randomized to Group A will receive CAFR first, then cross over to CAFRPlus.~Conducted AF Response (CAFR): The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.~Conducted AF Response Plus (CAFRPlus): The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing."
57679|NCT02221947|O2|Outcome|Placebo|Placebo: Placebo, single dose via intravenous infusion over 1 hour.
57468|NCT02222818|P2|Participant Flow|Group B: CAFRPlus First|"Subjects randomized to Group B will receive CAFRPlus first, then cross over to CAFR.~Conducted AF Response (CAFR): The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.~Conducted AF Response Plus (CAFRPlus): The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing."
57469|NCT02222818|P1|Participant Flow|Group A: CAFR First|"Subjects randomized to Group A will receive CAFR first, then cross over to CAFRPlus.~Conducted AF Response (CAFR): The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.~Conducted AF Response Plus (CAFRPlus): The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing."
57470|NCT02222818|O2|Outcome|CAFRPlus ON|Percentage of effective CRT pacing during AF when CAFRPlus is ON
57471|NCT02222818|O1|Outcome|CAFR ON|Percentage of effective CRT pacing during AF when CAFR is ON
57472|NCT02222818|O2|Outcome|CAFRPlus ON|Percentage of effective CRT pacing during AF when CAFRPlus is ON
57473|NCT02222818|O1|Outcome|CAFR ON|Percentage of effective CRT pacing during AF when CAFR is ON
57474|NCT02222818|E1|Reported Event|All Enrolled Subjects|All subjects enrolled in the CRTee study.
57475|NCT02222558|B1|Baseline|All Study Participants|"Study participants start in Period 1 and proceed to Period 2 and then Period 3 Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.~Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
57476|NCT02222558|P6|Participant Flow|Period 3: Three Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
57477|NCT02222558|P5|Participant Flow|Period 3: Two Times Daily Dosing 180 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
57478|NCT02222558|P4|Participant Flow|Period 3: Three Times Daily Dosing 90 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
57479|NCT02222558|P3|Participant Flow|Period 3: Two Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
57480|NCT02222558|P2|Participant Flow|Period 2: Two Times Daily Dosing 90 mg|Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.
57481|NCT02222558|P1|Participant Flow|Period 1: Single Dose|Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.
57482|NCT02222558|O6|Outcome|Period 3: Three Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
57483|NCT02222558|O5|Outcome|Period 3: Two Times Daily Dosing 180 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
57484|NCT02222558|O4|Outcome|Period 3: Three Times Daily Dosing 90 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
57485|NCT02222558|O3|Outcome|Period 3: Two Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
57486|NCT02222558|O2|Outcome|Period 2: Two Times Daily Dosing 90 mg|Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.
57487|NCT02222558|O1|Outcome|Period 1: Single Dose|Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.
57488|NCT02222558|E6|Reported Event|Period 3: Three Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
57489|NCT02222558|E5|Reported Event|Period 3: Two Times Daily Dosing 180 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
57490|NCT02222558|E4|Reported Event|Period 3: Three Times Daily Dosing 90 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
57491|NCT02222558|E3|Reported Event|Period 3: Two Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
57492|NCT02222558|E2|Reported Event|Period 2: Two Times Daily Dosing 90 mg|Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.
57493|NCT02222558|E1|Reported Event|Period 1: Single Dose|Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.
57494|NCT02222493|B3|Baseline|Total|Total of all reporting groups
57495|NCT02222493|B2|Baseline|Infliximab-EU Remicade (INX)|Participants received intravenous infusions of INX at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2), when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179.
57496|NCT02222493|B1|Baseline|PF-06438179|Participants received intravenous infusions of PF-06438179 at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2, when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179.
57497|NCT02222493|P2|Participant Flow|Infliximab-EU Remicade (INX)|Participants received intravenous infusions of INX at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2), when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179.
57498|NCT02222493|P1|Participant Flow|PF-06438179|Participants received intravenous infusions of PF-06438179 at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2, when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179.
57499|NCT02222493|O3|Outcome|Period 3: INX/PF-06438179/PF-06438179|Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57500|NCT02222493|O2|Outcome|Period 3: INX/INX/PF-06438179|Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57680|NCT02221947|O1|Outcome|Bryostatin 1|Bryostatin 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour.
60541|NCT02203786|O4|Outcome|Fluphenazine - Controls|A total of 15 controls were enrolled in this arm.
57501|NCT02222493|O1|Outcome|Period 3: PF-06438179/PF-06438179/PF-06438179|Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57502|NCT02222493|O3|Outcome|Period 2: INX/PF-06438179|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57503|NCT02222493|O2|Outcome|Period 2: INX/INX|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57504|NCT02222493|O1|Outcome|Period 2: PF-06438179/PF-06438179|Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57505|NCT02222493|O2|Outcome|Period 1: Infliximab-EU Remicade (INX)|Participants were scheduled to receive intravenous infusions INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57506|NCT02222493|O1|Outcome|Period 1: PF-06438179|Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57507|NCT02222493|O3|Outcome|Period 3: INX/PF-06438179/PF-06438179|Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57508|NCT02222493|O2|Outcome|Period 3: INX/INX/PF-06438179|Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57509|NCT02222493|O1|Outcome|Period 3: PF-06438179/PF-06438179/PF-06438179|Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57510|NCT02222493|O3|Outcome|Period 2: INX/PF-06438179|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57511|NCT02222493|O2|Outcome|Period 2: INX/INX|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57512|NCT02222493|O1|Outcome|Period 2: PF-06438179/PF-06438179|Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57513|NCT02222493|O2|Outcome|Period 1: Infliximab-EU Remicade (INX)|Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57514|NCT02222493|O1|Outcome|Period 1: PF-06438179|Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57515|NCT02222493|O3|Outcome|Period 3: INX/PF-06438179/PF-06438179|Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57516|NCT02222493|O2|Outcome|Period 3: INX/INX/PF-06438179|Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57517|NCT02222493|O1|Outcome|Period 3: PF-06438179/PF-06438179/PF-06438179|Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57518|NCT02222493|O3|Outcome|Period 2: INX/PF-06438179|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57519|NCT02222493|O2|Outcome|Period 2: INX/INX|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57520|NCT02222493|O1|Outcome|Period 2: PF-06438179/PF-06438179|Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57521|NCT02222493|O2|Outcome|Period 1: Infliximab-EU Remicade (INX)|Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
103218|NCT01963845|O1|Outcome|Placebo|Sitagliptin-matched placebo tablet
57522|NCT02222493|O1|Outcome|Period 1: PF-06438179|Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57523|NCT02222493|O3|Outcome|Period 3: INX/PF-06438179/PF-06438179|Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57524|NCT02222493|O2|Outcome|Period 3: INX/INX/PF-06438179|Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57525|NCT02222493|O1|Outcome|Period 3: PF-06438179/PF-06438179/PF-06438179|Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57526|NCT02222493|O3|Outcome|Period 2: INX/PF-06438179|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57527|NCT02222493|O2|Outcome|Period 2: INX/INX|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57528|NCT02222493|O1|Outcome|Period 2: PF-06438179/PF-06438179|Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57529|NCT02222493|O2|Outcome|Period 1: Infliximab-EU Remicade (INX)|Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57530|NCT02222493|O1|Outcome|Period 1: PF-06438179|Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57531|NCT02222493|O3|Outcome|Period 3: INX/PF-06438179/PF-06438179|Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57532|NCT02222493|O2|Outcome|Period 3: INX/INX/PF-06438179|Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57533|NCT02222493|O1|Outcome|Period 3: PF-06438179/PF-06438179/PF-06438179|Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57534|NCT02222493|O3|Outcome|Period 2: INX/PF-06438179|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57535|NCT02222493|O2|Outcome|Period 2: INX/INX|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57536|NCT02222493|O1|Outcome|Period 2: PF-06438179/PF-06438179|Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57537|NCT02222493|O2|Outcome|Period 1: Infliximab-EU Remicade (INX)|Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57538|NCT02222493|O1|Outcome|Period 1: PF-06438179|Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57539|NCT02222493|O3|Outcome|Period 3: INX/PF-06438179/PF-06438179|Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57540|NCT02222493|O2|Outcome|Period 3: INX/INX/PF-06438179|Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57541|NCT02222493|O1|Outcome|Period 3: PF-06438179/PF-06438179/PF-06438179|Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57542|NCT02222493|O3|Outcome|Period 2: INX/PF-06438179|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57718|NCT02221557|P1|Participant Flow|New Alloplastic Bone Graft Material|easy-graft (beta-Tricalcium Phosphate)
57543|NCT02222493|O2|Outcome|Period 2: INX/INX|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57544|NCT02222493|O1|Outcome|Period 2: PF-06438179/PF-06438179|Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57545|NCT02222493|O2|Outcome|Period 1: Infliximab-EU Remicade (INX)|Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57546|NCT02222493|O1|Outcome|Period 1: PF-06438179|Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57547|NCT02222493|O3|Outcome|Period 3: INX/PF-06438179/PF-06438179|Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57548|NCT02222493|O2|Outcome|Period 3: INX/INX/PF-06438179|Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57549|NCT02222493|O1|Outcome|Period 3: PF-06438179/PF-06438179/PF-06438179|Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57550|NCT02222493|O3|Outcome|Period 2: INX/PF-06438179|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57551|NCT02222493|O2|Outcome|Period 2: INX/INX|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57552|NCT02222493|O1|Outcome|Period 2: PF-06438179/PF-06438179|Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57553|NCT02222493|O2|Outcome|Period 1: Infliximab-EU Remicade (INX)|Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57554|NCT02222493|O1|Outcome|Period 1: PF-06438179|Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57555|NCT02222493|O3|Outcome|Period 3: INX/PF-06438179/PF-06438179|Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57556|NCT02222493|O2|Outcome|Period 3: INX/INX/PF-06438179|Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57557|NCT02222493|O1|Outcome|Period 3: PF-06438179/PF-06438179/PF-06438179|Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57558|NCT02222493|O3|Outcome|Period 2: INX/PF-06438179|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57559|NCT02222493|O2|Outcome|Period 2: INX/INX|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57560|NCT02222493|O1|Outcome|Period 2: PF-06438179/PF-06438179|Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57561|NCT02222493|O2|Outcome|Period 1: Infliximab-EU Remicade (INX)|Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57562|NCT02222493|O1|Outcome|Period 1: PF-06438179|Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57681|NCT02221947|O2|Outcome|Placebo|"single dose of placebo, intravenous infusion over 1 hour~Placebo: Placebo, single dose via intravenous infusion over 1 hour."
57563|NCT02222493|O3|Outcome|Period 3: INX/PF-06438179/PF-06438179|Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57564|NCT02222493|O2|Outcome|Period 3: INX/INX/PF-06438179|Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57565|NCT02222493|O1|Outcome|Period 3: PF-06438179/PF-06438179/PF-06438179|Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57566|NCT02222493|O3|Outcome|Period 2: INX/PF-06438179|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57567|NCT02222493|O2|Outcome|Period 2: INX/INX|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57568|NCT02222493|O1|Outcome|Period 2: PF-06438179/PF-06438179|Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57569|NCT02222493|O2|Outcome|Period 1: Infliximab-EU Remicade (INX)|Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57570|NCT02222493|O1|Outcome|Period 1: PF-06438179|Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57571|NCT02222493|O3|Outcome|Period 3: INX/PF-06438179/PF-06438179|Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57572|NCT02222493|O2|Outcome|Period 3: INX/INX/PF-06438179|Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57573|NCT02222493|O1|Outcome|Period 3: PF-06438179/PF-06438179/PF-06438179|Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57574|NCT02222493|O3|Outcome|Period 2: INX/PF-06438179|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57575|NCT02222493|O2|Outcome|Period 2: INX/INX|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57576|NCT02222493|O1|Outcome|Period 2: PF-06438179/PF-06438179|Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57577|NCT02222493|O2|Outcome|Period 1: Infliximab-EU Remicade (INX)|Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57578|NCT02222493|O1|Outcome|Period 1: PF-06438179|Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57579|NCT02222493|O3|Outcome|Period 3: INX/PF-06438179/PF-06438179|Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57580|NCT02222493|O2|Outcome|Period 3: INX/INX/PF-06438179|Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57581|NCT02222493|O1|Outcome|Period 3: PF-06438179/PF-06438179/PF-06438179|Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57582|NCT02222493|O3|Outcome|Period 2: INX/PF-06438179|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57583|NCT02222493|O2|Outcome|Period 2: INX/INX|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57584|NCT02222493|O1|Outcome|Period 2: PF-06438179/PF-06438179|Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57585|NCT02222493|O2|Outcome|Period 1: Infliximab-EU Remicade (INX)|Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57586|NCT02222493|O1|Outcome|Period 1: PF-06438179|Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57587|NCT02222493|O3|Outcome|Period 3: INX/PF-06438179/PF-06438179|Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57588|NCT02222493|O2|Outcome|Period 3: INX/INX/PF-06438179|Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57589|NCT02222493|O1|Outcome|Period 3: PF-06438179/PF-06438179/PF-06438179|Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57590|NCT02222493|O3|Outcome|Period 2: INX/PF-06438179|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57591|NCT02222493|O2|Outcome|Period 2: INX/INX|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57592|NCT02222493|O1|Outcome|Period 2: PF-06438179/PF-06438179|Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57593|NCT02222493|O2|Outcome|Period 1: Infliximab-EU Remicade (INX)|Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57594|NCT02222493|O1|Outcome|Period 1: PF-06438179|Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57595|NCT02222493|O3|Outcome|Period 3: INX/PF-06438179/PF-06438179|Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57596|NCT02222493|O2|Outcome|Period 3: INX/INX/PF-06438179|Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57597|NCT02222493|O1|Outcome|Period 3: PF-06438179/PF-06438179/PF-06438179|Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57598|NCT02222493|O3|Outcome|Period 2: INX/PF-06438179|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57599|NCT02222493|O2|Outcome|Period 2: INX/INX|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57600|NCT02222493|O1|Outcome|Period 2: PF-06438179/PF-06438179|Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57601|NCT02222493|O2|Outcome|Period 1: Infliximab-EU Remicade (INX)|Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57602|NCT02222493|O1|Outcome|Period 1: PF-06438179|Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57603|NCT02222493|O2|Outcome|Period 1: Infliximab-EU Remicade (INX)|Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57682|NCT02221947|O1|Outcome|Bryostatin 1|"single dose of 25 μg/m2 bryostatin, intravenous infusion over 1 hour~Bryostatin 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour."
57683|NCT02221947|E2|Reported Event|Placebo|"single dose of placebo, intravenous infusion over 1 hour~Placebo: Placebo, single dose via intravenous infusion over 1 hour."
57604|NCT02222493|O1|Outcome|Period 1: PF-06438179|Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57605|NCT02222493|E8|Reported Event|Period 3: INX/PF-06438179/PF-06438179|Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57606|NCT02222493|E7|Reported Event|Period 3: INX/INX/PF-06438179|Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57607|NCT02222493|E6|Reported Event|Period 3: PF-06438179/PF-06438179/PF-06438179|Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
57608|NCT02222493|E5|Reported Event|Period 2: INX/PF-06438179|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57609|NCT02222493|E4|Reported Event|Period 2: INX/INX|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57610|NCT02222493|E3|Reported Event|Period 2: PF-06438179/PF-06438179|Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
57611|NCT02222493|E2|Reported Event|Period 1: Infliximab-EU Remicade (INX)|Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57612|NCT02222493|E1|Reported Event|Period 1: PF-06438179|Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
57613|NCT02222246|B3|Baseline|Total|Total of all reporting groups
57614|NCT02222246|B2|Baseline|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.~Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.~Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
57615|NCT02222246|B1|Baseline|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.~Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).~Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
57616|NCT02222246|P2|Participant Flow|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.~Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.~Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
57617|NCT02222246|P1|Participant Flow|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent National Heart, Lung, and Blood Institute (NHBLI) recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.~Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a Sickle Cell Disease (SCD) specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).~Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
57684|NCT02221947|E1|Reported Event|Bryostatin 1|"single dose of 25 μg/m2 bryostatin, intravenous infusion over 1 hour~Bryostatin 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour."
57685|NCT02221674|B4|Baseline|Total|Total of all reporting groups
57719|NCT02221557|O1|Outcome|New Alloplastic Bone Graft Material|easy-graft (beta-Tricalcium Phosphate)
57720|NCT02221557|E1|Reported Event|New Alloplastic Bone Graft Material|easy-graft (beta-Tricalcium Phosphate)
57618|NCT02222246|O2|Outcome|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.~Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.~Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
57619|NCT02222246|O1|Outcome|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.~Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).~Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
57620|NCT02222246|O2|Outcome|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.~Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.~Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
57621|NCT02222246|O1|Outcome|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.~Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).~Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
57622|NCT02222246|O2|Outcome|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.~Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.~Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
57623|NCT02222246|O1|Outcome|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.~Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).~Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
57624|NCT02222246|O2|Outcome|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.~Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.~Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
57625|NCT02222246|O1|Outcome|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.~Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).~Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
57686|NCT02221674|B3|Baseline|Participants Aged From Birth to Less Than 1 Month|"Neonates aged less than 1 month at the time of allocation to IMP (must be ≥37 weeks gestational age).~Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight.~Neonates aged less than 1 month received a dose of 0.50 mg/kg."
57721|NCT02220998|B3|Baseline|Total|Total of all reporting groups
58002|NCT02219256|P1|Participant Flow|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
57626|NCT02222246|O2|Outcome|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.~Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.~Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
57627|NCT02222246|O1|Outcome|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.~Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).~Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
57628|NCT02222246|O2|Outcome|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.~Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.~Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
57629|NCT02222246|O1|Outcome|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.~Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).~Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
57630|NCT02222246|O2|Outcome|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.~Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.~Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
57631|NCT02222246|O1|Outcome|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.~Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).~Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
57632|NCT02222246|O2|Outcome|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.~Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.~Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
57633|NCT02222246|O1|Outcome|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.~Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).~Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
57687|NCT02221674|B2|Baseline|Participants Aged 1 Month to Less Than 6 Months|"Infants aged 1 month to less than 6 months at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight.~Infants aged 1 month to less than 6 months received a dose of 0.60 mg/kg."
57722|NCT02220998|B2|Baseline|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
103219|NCT01963845|O2|Outcome|Active Drug|"Sitagliptin 100 mg~Sitagliptin"
57634|NCT02222246|O2|Outcome|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.~Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.~Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
57635|NCT02222246|O1|Outcome|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.~Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).~Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
57636|NCT02222246|O2|Outcome|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.~Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).~Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
57637|NCT02222246|O1|Outcome|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.~Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.~Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
57638|NCT02222246|O2|Outcome|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.~Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.~Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
57639|NCT02222246|O1|Outcome|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.~Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).~Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
57640|NCT02222246|O2|Outcome|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.~Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.~Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
57641|NCT02222246|O1|Outcome|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.~Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).~Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
57688|NCT02221674|B1|Baseline|Participants Aged 6 Months to Less Than 2 Years|"Infants aged 6 months to less than 2 years at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight.~Infants aged 6 months to less than 2 years received a dose of 0.75 mg/kg."
57723|NCT02220998|B1|Baseline|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
58180|NCT02218307|O2|Outcome|Placebo|"Placebo control for mupirocin~Placebo"
57642|NCT02222246|E2|Reported Event|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.~Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).~Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
57643|NCT02222246|E1|Reported Event|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.~Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.~Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
57644|NCT02222207|B1|Baseline|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
57645|NCT02222207|P1|Participant Flow|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
57646|NCT02222207|O1|Outcome|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
57647|NCT02222207|O1|Outcome|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
57648|NCT02222207|O1|Outcome|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
57649|NCT02222207|O1|Outcome|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
57650|NCT02222207|E1|Reported Event|Part A Regorafenib|Participants self-administered 30 mg/mL, 25 mcL, 1 drop of regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
57651|NCT02222181|B1|Baseline|Treatment|patients in treatment for Alzheimer's disease.
57652|NCT02222181|P1|Participant Flow|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
57653|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
57654|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
57655|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
57656|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
57657|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
57658|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
57659|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
57660|NCT02222181|E1|Reported Event|Treatment|Do not apply.
57661|NCT02222129|B3|Baseline|Total|Total of all reporting groups
57662|NCT02222129|B2|Baseline|Liposomal Bupivacaine|"Surgical site infiltration of liposomal bupivacaine.~liposomal bupivacaine"
57663|NCT02222129|B1|Baseline|Bupivacaine|"Surgical site infiltration of 0.25% bupivacaine.~Bupivacaine"
57664|NCT02222129|P2|Participant Flow|Liposomal Bupivacaine|"Surgical site infiltration of liposomal bupivacaine.~liposomal bupivacaine"
57665|NCT02222129|P1|Participant Flow|Bupivacaine|"Surgical site infiltration of 0.25% bupivacaine.~Bupivacaine"
57666|NCT02222129|O2|Outcome|Liposomal Bupivacaine|"Surgical site infiltration of liposomal bupivacaine.~liposomal bupivacaine"
57667|NCT02222129|O1|Outcome|Bupivacaine|"Surgical site infiltration of 0.25% bupivacaine.~Bupivacaine"
57668|NCT02222129|E2|Reported Event|Liposomal Bupivacaine|"Surgical site infiltration of liposomal bupivacaine.~liposomal bupivacaine"
57669|NCT02222129|E1|Reported Event|Bupivacaine|"Surgical site infiltration of 0.25% bupivacaine.~Bupivacaine"
57670|NCT02221947|B3|Baseline|Total|Total of all reporting groups
57671|NCT02221947|B2|Baseline|Placebo|"single dose of placebo, intravenous infusion over 1 hour~Placebo: Placebo, single dose via intravenous infusion over 1 hour."
57672|NCT02221947|B1|Baseline|Bryostatin 1|"single dose of 25 μg/m2 bryostatin, intravenous infusion over 1 hour~Bryostatin 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour."
57673|NCT02221947|P2|Participant Flow|Placebo|"single dose of placebo, intravenous infusion over 1 hour~Placebo: Placebo, single dose via intravenous infusion over 1 hour."
57674|NCT02221947|P1|Participant Flow|Bryostatin 1|"single dose of 25 μg/m2 bryostatin, intravenous infusion over 1 hour~Bryostatin 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour."
57675|NCT02221947|O2|Outcome|Placebo|Placebo: Placebo, single dose via intravenous infusion over 1 hour.
57676|NCT02221947|O1|Outcome|Bryostatin 1|Bryostatin 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour.
57677|NCT02221947|O2|Outcome|Placebo|Placebo: single dose via intravenous infusion over 1 hour.
57678|NCT02221947|O1|Outcome|Bryostatin 1|Bryostatin 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour.
57689|NCT02221674|P3|Participant Flow|Participants Aged From Birth to Less Than 1 Month|"Neonates aged less than 1 month at the time of allocation to IMP (must be ≥37 weeks gestational age).~Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight.~Neonates aged less than 1 month received a dose of 0.50 mg/kg."
57690|NCT02221674|P2|Participant Flow|Participants Aged 1 Month to Less Than 6 Months|"Infants aged 1 month to less than 6 months at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight.~Infants aged 1 month to less than 6 months received a dose of 0.60 mg/kg."
57691|NCT02221674|P1|Participant Flow|Participants Aged 6 Months to Less Than 2 Years|"Infants aged 6 months to less than 2 years at the time of allocation to IMP (investigational medicinal product).~Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight.~Infants aged 6 months to less than 2 years received a dose of 0.75 mg/kg."
57692|NCT02221674|O3|Outcome|Participants Aged From Birth to Less Than 1 Month.|"Neonates aged less than 1 month at the time of allocation to IMP (must be ≥37 weeks gestational age).~Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight.~Neonates aged less than 1 month received a dose of 0.50 mg/kg."
57693|NCT02221674|O2|Outcome|Participants Aged 1 Month to Less Than 6 Months.|"Infants aged 1 month to less than 6 months at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight.~Infants aged 1 month to less than 6 months received a dose of 0.60 mg/kg."
57694|NCT02221674|O1|Outcome|Participants Aged 6 Months to Less Than 2 Years.|"Infants aged 6 months to less than 2 years at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight.~Infants aged 6 months to less than 2 years received a dose of 0.75 mg/kg."
57695|NCT02221674|O1|Outcome|Participants Aged From Birth to Less Than 1 Month - PK Set|Neonates aged less than 1 month (must be ≥37 weeks gestational age) at the time of allocation to IMP who had quantifiable serum concentrations.
57696|NCT02221674|O1|Outcome|Participants Aged 1 Month to Less Than 6 Months - PK Set|Infants aged 1 month to less than 6 months at the time of allocation to IMP who had quantifiable serum concentrations.
57697|NCT02221674|O1|Outcome|Participants Aged 6 Months to Less Than 2 Years - PK Set|Infants aged 6 months to less than 2 years at the time of allocation to IMP who had quantifiable serum concentrations.
57698|NCT02221674|O1|Outcome|Participants Aged From Birth to Less Than 1 Month - PK Set|Neonates aged less than 1 month (must be ≥37 weeks gestational age) at the time of allocation to IMP who had quantifiable serum concentrations.
57699|NCT02221674|O1|Outcome|Participants Aged 1 Month to Less Than 6 Months - PK Set|Infants aged 1 month to less than 6 months at the time of allocation to IMP who had quantifiable serum concentrations.
57700|NCT02221674|O1|Outcome|Participants Aged 6 Months to Less Than 2 Years - PK Set|Infants aged 6 months to less than 2 years at the time of allocation to IMP who had quantifiable serum concentrations.
57701|NCT02221674|E3|Reported Event|Participants Aged From Birth to Less Than 1 Month.|"Neonates aged less than 1 month at the time of allocation to IMP (must be ≥37 weeks gestational age).~Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight.~Neonates aged less than 1 month received a dose of 0.50 mg/kg."
57702|NCT02221674|E2|Reported Event|Participants Aged 1 Month to Less Than 6 Months.|"Infants aged 1 month to less than 6 months at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight.~Infants aged 1 month to less than 6 months received a dose of 0.60 mg/kg."
57703|NCT02221674|E1|Reported Event|Participants Aged 6 Months to Less Than 2 Years.|"Infants aged 6 months to less than 2 years at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight.~Infants aged 6 months to less than 2 years received a dose of 0.75 mg/kg."
57704|NCT02221648|B3|Baseline|Total|Total of all reporting groups
57705|NCT02221648|B2|Baseline|AbobotulinumtoxinA Treatment|All subjects will receive intervention injections with the study drug abobotulinumtoxinA.
57706|NCT02221648|B1|Baseline|Placebo|Subjects will be randomization to receive injections with either the study drug (incobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive for the first injections.
57707|NCT02221648|P2|Participant Flow|ArbobotulinumtoxinA Treatment|"Subjects will receive intervention injections with the study drug abobotulinumtoxinA.~AbobotulinumtoxinA Treatment: All subjects will receive intervention injections with the study drug arbobotulinumtoxinA. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment."
57708|NCT02221648|P1|Participant Flow|Placebo|Subjects will be randomized to receive injections with either the study drug (abobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive for the first injections.
57709|NCT02221648|O2|Outcome|AbobotulinumtoxinA Treatment|"Subjects will be randomized to receive intervention injections with the study drug arbobotulinumtoxinA.~AbobotulinumtoxinA Treatment: Subjects receive intervention injections with the study drug arbobotulinumtoxinA."
57710|NCT02221648|O1|Outcome|Placebo|"Subjects will be randomization to receive injections with either the study drug (abobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive.~Placebo: Subjects will be randomization to receive either the study drug or the placebo group."
57711|NCT02221648|O2|Outcome|botulinumtoxinA Treatment|Subjects received botox injection.
57712|NCT02221648|O1|Outcome|Placebo|Study group received placebo injection.
57713|NCT02221648|O2|Outcome|AbobotulinumtoxinA Treatment|All subjects will receive intervention injections with the study drug arbobotulinumtoxinA.
57714|NCT02221648|O1|Outcome|Placebo|Subjects will be randomized to receive injections with saline.
57715|NCT02221648|E2|Reported Event|ArbobotulinumtoxinA Treatment|AbobotulinumtoxinA Treatment: All subjects will receive intervention injections with the study drug arbobotulinumtoxinA.
57724|NCT02220998|P2|Participant Flow|SOF+RBV|Sofosbuvir (SOF) 400 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
57725|NCT02220998|P1|Participant Flow|SOF/VEL|Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered orally once daily for 12 weeks
57726|NCT02220998|O2|Outcome|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
57727|NCT02220998|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
57728|NCT02220998|O2|Outcome|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
57729|NCT02220998|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
57730|NCT02220998|O2|Outcome|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
57731|NCT02220998|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
57732|NCT02220998|O2|Outcome|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
57733|NCT02220998|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
57734|NCT02220998|O2|Outcome|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
57735|NCT02220998|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
57736|NCT02220998|O2|Outcome|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
57737|NCT02220998|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
57738|NCT02220998|E2|Reported Event|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
57739|NCT02220998|E1|Reported Event|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
57740|NCT02220920|B3|Baseline|Total|Total of all reporting groups
57741|NCT02220920|B2|Baseline|Placebo＋Insulin|Placebo, once daily for 16 weeks
57742|NCT02220920|B1|Baseline|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
57743|NCT02220920|P2|Participant Flow|Placebo＋Insulin|Placebo, once daily for 16 weeks
57744|NCT02220920|P1|Participant Flow|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
57745|NCT02220920|O2|Outcome|Placebo＋Insulin|Placebo, once daily for 16 weeks
57746|NCT02220920|O1|Outcome|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
57747|NCT02220920|O2|Outcome|Placebo＋Insulin|Placebo, once daily for 16 weeks
57748|NCT02220920|O1|Outcome|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
57749|NCT02220920|O2|Outcome|Placebo＋Insulin|Placebo, once daily for 16 weeks
57750|NCT02220920|O1|Outcome|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
57751|NCT02220920|O2|Outcome|Placebo＋Insulin|Placebo, once daily for 16 weeks
57752|NCT02220920|O1|Outcome|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
57753|NCT02220920|O2|Outcome|Placebo＋Insulin|Placebo, once daily for 16 weeks
57754|NCT02220920|O1|Outcome|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
57755|NCT02220920|E2|Reported Event|Placebo＋Insulin|Placebo, once daily for 16 weeks
57756|NCT02220920|E1|Reported Event|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
57757|NCT02220764|B3|Baseline|Total|Total of all reporting groups
57758|NCT02220764|B2|Baseline|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses~Implant abutments"
57759|NCT02220764|B1|Baseline|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses~Teeth abutment"
57760|NCT02220764|P2|Participant Flow|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses~Implant abutments"
57761|NCT02220764|P1|Participant Flow|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses~Teeth abutment"
57762|NCT02220764|O2|Outcome|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses~Implant abutments"
57763|NCT02220764|O1|Outcome|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses~Teeth abutment"
57764|NCT02220764|O2|Outcome|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses~Implant abutments"
57765|NCT02220764|O1|Outcome|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses~Teeth abutment"
57766|NCT02220764|O2|Outcome|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses~Implant abutments"
57767|NCT02220764|O1|Outcome|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses~Teeth abutment"
57768|NCT02220764|E2|Reported Event|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses~Implant abutments"
57769|NCT02220764|E1|Reported Event|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses~Teeth abutment"
57770|NCT02220205|B3|Baseline|Total|Total of all reporting groups
57771|NCT02220205|B2|Baseline|Manufacturer Model|"Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.~Manufacturer model"
57772|NCT02220205|B1|Baseline|PelvicSim|"Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.~PelvicSim"
57773|NCT02220205|P2|Participant Flow|Manufacturer Model|"Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.~Manufacturer model"
57774|NCT02220205|P1|Participant Flow|PelvicSim|"Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.~PelvicSim"
57775|NCT02220205|O2|Outcome|Manufacturer Model|"Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.~Manufacturer model"
57776|NCT02220205|O1|Outcome|PelvicSim|"Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.~PelvicSim"
58181|NCT02218307|O1|Outcome|Mupirocin|"topical antibiotic~Mupirocin"
57777|NCT02220205|O2|Outcome|Manufacturer Model|"Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.~Manufacturer model"
57778|NCT02220205|O1|Outcome|PelvicSim|"Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.~PelvicSim"
57779|NCT02220205|E2|Reported Event|Manufacturer Model|"Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.~Manufacturer model"
57780|NCT02220205|E1|Reported Event|PelvicSim|"Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.~PelvicSim"
57781|NCT02219997|B3|Baseline|Total|Total of all reporting groups
57782|NCT02219997|B2|Baseline|Clear IOL|Clear IOL with blue light filter clip-on glasses and clear clip-on glasses, worn in a cross-over fashion, as randomized, for 4 hours total
57783|NCT02219997|B1|Baseline|AcrySof IQ IOL|ACRYSOF® IQ IOL with clear clip-on glasses worn for 3 hours
57784|NCT02219997|P3|Participant Flow|Clear IOL: Placebo Filter First, Then BLF|Clear IOL with clear clip-on glasses worn first and blue light filter clip-on glasses worn second for 4 hours total
57785|NCT02219997|P2|Participant Flow|Clear IOL: BLF First, Then Placebo Filter|Clear IOL with blue light filter clip-on glasses worn first and clear clip-on glasses worn second for 4 hours total
57786|NCT02219997|P1|Participant Flow|AcrySof IQ IOL|ACRYSOF® IQ IOL with clear clip-on glasses worn for 3 hours
57787|NCT02219997|O2|Outcome|Clear IOL + BLF|Clear IOL with clip-on glasses with blue light filtering properties
57788|NCT02219997|O1|Outcome|ACRYSOF IQ IOL + Placebo Filter|ACRYSOF® IQ IOL with clear clip-on glasses with no light filtering properties used as a placebo
57789|NCT02219997|O2|Outcome|Blue Light Filter|Clear IOL with clip-on glasses with blue light filtering properties
57790|NCT02219997|O1|Outcome|Placebo Filter|Clear IOLs with placebo colored clip-on filters
57791|NCT02219997|O2|Outcome|Clear IOL|Clear IOL without filters
57792|NCT02219997|O1|Outcome|AcrySof IQ IOL|ACRYSOF® IQ IOL without filters
57793|NCT02219997|E3|Reported Event|Clear IOL|All subjects implanted with Clear IOLs from time of initiation of experimental testing
57794|NCT02219997|E2|Reported Event|AcrySof IQ IOL|All subjects implanted with ACRYSOF® IQ IOLs from time of initiation of experimental testing
57795|NCT02219997|E1|Reported Event|Pre-treatment|All subjects from time to consent until initiation of experimental testing
57796|NCT02219932|B3|Baseline|Total|Total of all reporting groups
57797|NCT02219932|B2|Baseline|Fampridine 10 mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
57798|NCT02219932|B1|Baseline|Placebo|Placebo BID for up to 24 weeks
57799|NCT02219932|P2|Participant Flow|Fampridine 10 mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
57800|NCT02219932|P1|Participant Flow|Placebo|Placebo twice daily (BID) for up to 24 weeks
57801|NCT02219932|O2|Outcome|Fampridine 10 mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
57802|NCT02219932|O1|Outcome|Placebo|Placebo BID for up to 24 weeks
57803|NCT02219932|O2|Outcome|Fampridine 10 mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
57804|NCT02219932|O1|Outcome|Placebo|Placebo BID for up to 24 weeks
57805|NCT02219932|O2|Outcome|Fampridine 10 mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
57806|NCT02219932|O1|Outcome|Placebo|Placebo BID for up to 24 weeks
57807|NCT02219932|O2|Outcome|Fampridine 10 mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
57808|NCT02219932|O1|Outcome|Placebo|Placebo BID for up to 24 weeks
57809|NCT02219932|O2|Outcome|Fampridine 10 mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
57810|NCT02219932|O1|Outcome|Placebo|Placebo BID for up to 24 weeks
57811|NCT02219932|E2|Reported Event|Fampridine 10mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
57812|NCT02219932|E1|Reported Event|Placebo|Placebo twice daily (BID) for up to 24 weeks
57813|NCT02219685|B3|Baseline|Total|Total of all reporting groups
57814|NCT02219685|B2|Baseline|Placebo|LDV/SOF placebo tablet once daily for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
57815|NCT02219685|B1|Baseline|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
57816|NCT02219685|P2|Participant Flow|Placebo, Followed by Open-Label LDV/SOF|LDV/SOF placebo tablet once daily for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
57817|NCT02219685|P1|Participant Flow|LDV/SOF|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks
57818|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
57819|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
57820|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
57821|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
57822|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
57823|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
57824|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
57825|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
57826|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
57827|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
57828|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
57829|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
57830|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
57831|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
57832|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
57833|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
57834|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
57835|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
57836|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
57837|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
57838|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
57839|NCT02219685|O2|Outcome|Open-Label Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Open-Label Treatment Phase
57840|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
57841|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
57842|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
57843|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
57844|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
57845|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
57846|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
57847|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
57848|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
57849|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
57850|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
57851|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
57852|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
57853|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
57854|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
57855|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
57856|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
57857|NCT02219685|E3|Reported Event|LDV/SOF (Open-Label Phase), Following Placebo in Blinded Phase|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Open-Label Treatment Phase
57858|NCT02219685|E2|Reported Event|Placebo (Blinded Phase)|LDV/SOF placebo tablet once daily for 12 weeks
57859|NCT02219685|E1|Reported Event|LDV/SOF (Blinded Phase)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
57860|NCT02219516|B5|Baseline|Total|Total of all reporting groups
57861|NCT02219516|B4|Baseline|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
57862|NCT02219516|B3|Baseline|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
57863|NCT02219516|B2|Baseline|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
57864|NCT02219516|B1|Baseline|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
57865|NCT02219516|P4|Participant Flow|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
57866|NCT02219516|P3|Participant Flow|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
57867|NCT02219516|P2|Participant Flow|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
57868|NCT02219516|P1|Participant Flow|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
57869|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
57870|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
57871|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
57872|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
57873|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
57874|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
57875|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
57998|NCT02219256|P5|Participant Flow|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
57876|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
57877|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
57878|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
57879|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
57880|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
57881|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
57882|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
57883|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
57884|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
57885|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
57886|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
57887|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
57888|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
57889|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
57890|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
57891|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
57892|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
57893|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
57894|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
57895|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
57896|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
57897|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
57898|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
57899|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
57900|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
57901|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
57902|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
57903|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
57904|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
57905|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
57906|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
57907|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
57908|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
57909|NCT02219516|E4|Reported Event|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
57910|NCT02219516|E3|Reported Event|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
57911|NCT02219516|E2|Reported Event|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
57912|NCT02219516|E1|Reported Event|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
57913|NCT02219503|B1|Baseline|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
57914|NCT02219503|P1|Participant Flow|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
57915|NCT02219503|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
57999|NCT02219256|P4|Participant Flow|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
57916|NCT02219503|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
57917|NCT02219503|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
57918|NCT02219503|E1|Reported Event|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
57919|NCT02219477|B4|Baseline|Total|Total of all reporting groups
57920|NCT02219477|B3|Baseline|Group 3: GT4|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
57921|NCT02219477|B2|Baseline|Group 2: GT1 Non-B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
57922|NCT02219477|B1|Baseline|Group 1: GT1B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
57923|NCT02219477|P3|Participant Flow|Group 3: GT4|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
57924|NCT02219477|P2|Participant Flow|Group 2: GT1 Non-B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
57925|NCT02219477|P1|Participant Flow|Group 1: GT1B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) + ribavirin (RBV) for 12 weeks in hepatitis C virus (HCV) genotype (GT) 1b-infected participants
57926|NCT02219477|O3|Outcome|Group 3: GT4|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
57927|NCT02219477|O2|Outcome|Group 2: GT1 Non-B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
57928|NCT02219477|O1|Outcome|Group 1: GT1B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
57929|NCT02219477|O3|Outcome|Group 3: GT4|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
57930|NCT02219477|O2|Outcome|Group 2: GT1 Non-B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
57931|NCT02219477|O1|Outcome|Group 1: GT1B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
57932|NCT02219477|O3|Outcome|Group 3: GT4|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
57933|NCT02219477|O2|Outcome|Group 2: GT1 Non-B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
57934|NCT02219477|O1|Outcome|Group 1: GT1B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
57935|NCT02219477|O3|Outcome|Group 3: GT4|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
57936|NCT02219477|O2|Outcome|Group 2: GT1 Non-B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
57937|NCT02219477|O1|Outcome|Group 1: GT1B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
57938|NCT02219477|O3|Outcome|Group 3: GT4|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
57939|NCT02219477|O2|Outcome|Group 2: GT1 Non-B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
57940|NCT02219477|O1|Outcome|Group 1: GT1B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
57941|NCT02219477|O3|Outcome|Group 3: GT4|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
57942|NCT02219477|O2|Outcome|Group 2: GT1 Non-B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
57943|NCT02219477|O1|Outcome|Group 1: GT1B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
57944|NCT02219477|O1|Outcome|Group 3: GT4|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
57945|NCT02219477|O2|Outcome|Group 2: GT1 Non-B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
57946|NCT02219477|O1|Outcome|Group 1: GT1B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
57947|NCT02219477|E3|Reported Event|Group 3: GT4|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
57948|NCT02219477|E2|Reported Event|Group 2: GT1 Non-B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
57949|NCT02219477|E1|Reported Event|Group 1: GT1B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
57950|NCT02219464|B3|Baseline|Total|Total of all reporting groups
57951|NCT02219464|B2|Baseline|Nasal Cannula|"Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.~Nasal Cannula~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
57952|NCT02219464|B1|Baseline|Nasopharyngeal Catheter|"Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.~Nasopharyngeal catheter~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
58000|NCT02219256|P3|Participant Flow|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
58182|NCT02218307|E2|Reported Event|Placebo|"Placebo control for mupirocin~Placebo"
57953|NCT02219464|P2|Participant Flow|Nasal Cannula|"Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.~Nasal Cannula~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
57954|NCT02219464|P1|Participant Flow|Nasopharyngeal Catheter|"Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.~Nasopharyngeal catheter~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
57955|NCT02219464|O2|Outcome|Nasal Cannula|"Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.~Nasal Cannula~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
57956|NCT02219464|O1|Outcome|Nasopharyngeal Catheter|"Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.~Nasopharyngeal catheter~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
57957|NCT02219464|O2|Outcome|Nasal Cannula|"Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.~Nasal Cannula~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
57958|NCT02219464|O1|Outcome|Nasopharyngeal Catheter|"Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.~Nasopharyngeal catheter~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
57959|NCT02219464|E2|Reported Event|Nasal Cannula|"Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.~Nasal Cannula~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
57960|NCT02219464|E1|Reported Event|Nasopharyngeal Catheter|"Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.~Nasopharyngeal catheter~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
57961|NCT02219282|B3|Baseline|Total|Total of all reporting groups
57962|NCT02219282|B2|Baseline|Group Edentulous|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
57963|NCT02219282|B1|Baseline|Group Dentulous|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
57964|NCT02219282|P2|Participant Flow|Group Edentulous|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
57965|NCT02219282|P1|Participant Flow|Group Dentulous|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
57966|NCT02219282|O2|Outcome|Edentulous Group|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience"
57967|NCT02219282|O1|Outcome|Dentilous Group|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience"
57968|NCT02219282|O2|Outcome|Edentuolus|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience"
58001|NCT02219256|P2|Participant Flow|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
103220|NCT01963845|O1|Outcome|Placebo|Sitagliptin-matched placebo tablet
57969|NCT02219282|O1|Outcome|Dentulous|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience"
57970|NCT02219282|O2|Outcome|Group Edentulous|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
57971|NCT02219282|O1|Outcome|Group Dentulous|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
57972|NCT02219282|O2|Outcome|Group Edentulous|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
57973|NCT02219282|O1|Outcome|Group Dentulous|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
57974|NCT02219282|O2|Outcome|Group Edentulous|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
57975|NCT02219282|O1|Outcome|Group Dentulous|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
57976|NCT02219282|E2|Reported Event|Group Edentulous|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
57977|NCT02219282|E1|Reported Event|Group Dentulous|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
57978|NCT02219256|B13|Baseline|Total|Total of all reporting groups
57979|NCT02219256|B12|Baseline|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
57980|NCT02219256|B11|Baseline|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
57981|NCT02219256|B10|Baseline|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
57982|NCT02219256|B9|Baseline|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
57983|NCT02219256|B8|Baseline|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
57984|NCT02219256|B7|Baseline|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
57985|NCT02219256|B6|Baseline|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
57986|NCT02219256|B5|Baseline|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
57987|NCT02219256|B4|Baseline|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
57988|NCT02219256|B3|Baseline|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
57989|NCT02219256|B2|Baseline|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
57990|NCT02219256|B1|Baseline|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
57991|NCT02219256|P12|Participant Flow|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
57992|NCT02219256|P11|Participant Flow|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
57993|NCT02219256|P10|Participant Flow|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
57994|NCT02219256|P9|Participant Flow|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
57995|NCT02219256|P8|Participant Flow|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
57996|NCT02219256|P7|Participant Flow|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
57997|NCT02219256|P6|Participant Flow|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
58003|NCT02219256|O12|Outcome|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
58004|NCT02219256|O11|Outcome|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
58005|NCT02219256|O10|Outcome|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
58006|NCT02219256|O9|Outcome|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
58007|NCT02219256|O8|Outcome|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
58008|NCT02219256|O7|Outcome|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
58009|NCT02219256|O6|Outcome|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
58010|NCT02219256|O5|Outcome|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
58011|NCT02219256|O4|Outcome|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
58012|NCT02219256|O3|Outcome|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
58013|NCT02219256|O2|Outcome|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
58014|NCT02219256|O1|Outcome|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
58015|NCT02219256|O12|Outcome|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
58016|NCT02219256|O11|Outcome|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
58017|NCT02219256|O10|Outcome|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
58018|NCT02219256|O9|Outcome|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
58019|NCT02219256|O8|Outcome|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
58020|NCT02219256|O7|Outcome|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
58021|NCT02219256|O6|Outcome|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
58022|NCT02219256|O5|Outcome|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
58023|NCT02219256|O4|Outcome|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
58024|NCT02219256|O3|Outcome|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
58025|NCT02219256|O2|Outcome|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
58026|NCT02219256|O1|Outcome|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
58027|NCT02219256|O12|Outcome|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
58028|NCT02219256|O11|Outcome|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
58029|NCT02219256|O10|Outcome|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
58030|NCT02219256|O9|Outcome|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
58031|NCT02219256|O8|Outcome|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
58032|NCT02219256|O7|Outcome|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
58033|NCT02219256|O6|Outcome|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
58034|NCT02219256|O5|Outcome|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
58035|NCT02219256|O4|Outcome|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
58036|NCT02219256|O3|Outcome|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
58037|NCT02219256|O2|Outcome|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
58038|NCT02219256|O1|Outcome|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
58039|NCT02219256|O12|Outcome|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
58040|NCT02219256|O11|Outcome|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
58041|NCT02219256|O10|Outcome|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
58042|NCT02219256|O9|Outcome|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
58043|NCT02219256|O8|Outcome|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
58044|NCT02219256|O7|Outcome|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
58045|NCT02219256|O6|Outcome|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
58046|NCT02219256|O5|Outcome|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
58047|NCT02219256|O4|Outcome|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
58048|NCT02219256|O3|Outcome|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
58049|NCT02219256|O2|Outcome|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
58050|NCT02219256|O1|Outcome|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
58051|NCT02219256|O12|Outcome|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
58052|NCT02219256|O11|Outcome|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
58053|NCT02219256|O10|Outcome|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
58054|NCT02219256|O9|Outcome|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
58055|NCT02219256|O8|Outcome|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
58056|NCT02219256|O7|Outcome|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
58057|NCT02219256|O6|Outcome|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
58058|NCT02219256|O5|Outcome|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
58059|NCT02219256|O4|Outcome|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
103221|NCT01963845|O2|Outcome|Active Drug|"Sitagliptin 100 mg~Sitagliptin"
58060|NCT02219256|O3|Outcome|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
58061|NCT02219256|O2|Outcome|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
58062|NCT02219256|O1|Outcome|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
58063|NCT02219256|O12|Outcome|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
58064|NCT02219256|O11|Outcome|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
58065|NCT02219256|O10|Outcome|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
58066|NCT02219256|O9|Outcome|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
58067|NCT02219256|O8|Outcome|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
58068|NCT02219256|O7|Outcome|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
58069|NCT02219256|O6|Outcome|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
58070|NCT02219256|O5|Outcome|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
58071|NCT02219256|O4|Outcome|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
58072|NCT02219256|O3|Outcome|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
58073|NCT02219256|O2|Outcome|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
58074|NCT02219256|O1|Outcome|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
58075|NCT02219256|O12|Outcome|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
58076|NCT02219256|O11|Outcome|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
58077|NCT02219256|O10|Outcome|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
58078|NCT02219256|O9|Outcome|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
58079|NCT02219256|O8|Outcome|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
58080|NCT02219256|O7|Outcome|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
58081|NCT02219256|O6|Outcome|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
58082|NCT02219256|O5|Outcome|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
58083|NCT02219256|O4|Outcome|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
58084|NCT02219256|O3|Outcome|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
58085|NCT02219256|O2|Outcome|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
58086|NCT02219256|O1|Outcome|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
58087|NCT02219256|O12|Outcome|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
58088|NCT02219256|O11|Outcome|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
58089|NCT02219256|O10|Outcome|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
58090|NCT02219256|O9|Outcome|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
58091|NCT02219256|O8|Outcome|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
58092|NCT02219256|O7|Outcome|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
58093|NCT02219256|O6|Outcome|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
58094|NCT02219256|O5|Outcome|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
58095|NCT02219256|O4|Outcome|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
58096|NCT02219256|O3|Outcome|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
58097|NCT02219256|O2|Outcome|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
58098|NCT02219256|O1|Outcome|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
58099|NCT02219256|E12|Reported Event|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
58100|NCT02219256|E11|Reported Event|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
58101|NCT02219256|E10|Reported Event|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
58102|NCT02219256|E9|Reported Event|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
58103|NCT02219256|E8|Reported Event|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
58104|NCT02219256|E7|Reported Event|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
58105|NCT02219256|E6|Reported Event|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
58106|NCT02219256|E5|Reported Event|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
58107|NCT02219256|E4|Reported Event|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
58108|NCT02219256|E3|Reported Event|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
58109|NCT02219256|E2|Reported Event|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
58110|NCT02219256|E1|Reported Event|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
58111|NCT02219087|B3|Baseline|Total|Total of all reporting groups
58112|NCT02219087|B2|Baseline|Standard of Care|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.~ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia"
58113|NCT02219087|B1|Baseline|Liposomal Bupivacaine|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.~Liposomal bupivacaine"
58114|NCT02219087|P2|Participant Flow|Standard of Care|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.~ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia"
58115|NCT02219087|P1|Participant Flow|Liposomal Bupivacaine|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.~Liposomal bupivacaine"
58116|NCT02219087|O2|Outcome|Standard of Care|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.~ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia"
58117|NCT02219087|O1|Outcome|Liposomal Bupivacaine|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.~Liposomal bupivacaine"
58118|NCT02219087|O2|Outcome|Standard of Care|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.~ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia"
58119|NCT02219087|O1|Outcome|Liposomal Bupivacaine|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.~Liposomal bupivacaine"
58120|NCT02219087|O2|Outcome|Standard of Care|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.~ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia"
58121|NCT02219087|O1|Outcome|Liposomal Bupivacaine|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.~Liposomal bupivacaine"
58122|NCT02219087|O2|Outcome|Standard of Care|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.~ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia"
58123|NCT02219087|O1|Outcome|Liposomal Bupivacaine|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.~Liposomal bupivacaine"
58124|NCT02219087|O2|Outcome|Standard of Care|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.~ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia"
58125|NCT02219087|O1|Outcome|Liposomal Bupivacaine|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.~Liposomal bupivacaine"
58126|NCT02219087|O2|Outcome|Standard of Care|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.~ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia"
58127|NCT02219087|O1|Outcome|Liposomal Bupivacaine|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.~Liposomal bupivacaine"
58128|NCT02219087|O2|Outcome|Standard of Care|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.~ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia"
58129|NCT02219087|O1|Outcome|Liposomal Bupivacaine|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.~Liposomal bupivacaine"
58130|NCT02219087|E2|Reported Event|Standard of Care|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.~ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia"
58131|NCT02219087|E1|Reported Event|Liposomal Bupivacaine|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.~Liposomal bupivacaine"
58132|NCT02218697|B3|Baseline|Total|Total of all reporting groups
58133|NCT02218697|B2|Baseline|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
58134|NCT02218697|B1|Baseline|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
58135|NCT02218697|P2|Participant Flow|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
58136|NCT02218697|P1|Participant Flow|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
58137|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
58183|NCT02218307|E1|Reported Event|Mupirocin|"topical antibiotic~Mupirocin"
58138|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
58139|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
58140|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
58141|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
58142|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
58143|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
58144|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
58145|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
58146|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
58147|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
58148|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
58149|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
58150|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
58151|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
58152|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
58153|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
58154|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
58155|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
58156|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
58157|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
58158|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
58159|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
58160|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
58161|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
58162|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
58163|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
58164|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
58165|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
58166|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
58167|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
58168|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
58169|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
58170|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
58171|NCT02218697|E2|Reported Event|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
58172|NCT02218697|E1|Reported Event|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
58173|NCT02218307|B3|Baseline|Total|Total of all reporting groups
58174|NCT02218307|B2|Baseline|Placebo|"Placebo control for mupirocin~Placebo"
58175|NCT02218307|B1|Baseline|Mupirocin|"topical antibiotic~Mupirocin"
58176|NCT02218307|P2|Participant Flow|Placebo|"Placebo control for mupirocin~Placebo"
58177|NCT02218307|P1|Participant Flow|Mupirocin|"topical antibiotic~Mupirocin"
58178|NCT02218307|O2|Outcome|Placebo|"Placebo control for mupirocin~Placebo"
58179|NCT02218307|O1|Outcome|Mupirocin|"topical antibiotic~Mupirocin"
58184|NCT02218268|B1|Baseline|All Participants|This is a crossover study of youth with Diabetes on a stable basal bolus insulin regimen. They will be randomized either receive a pre-meal insulin bolus in conjunction with their Basal insulin bolus or receive their standard of care basal insulin bolus only. A mixed meal replacement (Boost) will be consumed. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring. This is a crossover study and all participants will take place in this arm after 3 months of their visit.
58185|NCT02218268|P2|Participant Flow|No Meal Bolus Then Pre-meal Bolus|"A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.~Then 3 months later meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring."
58186|NCT02218268|P1|Participant Flow|Pre-meal Bolus Then No Meal Bolus|"A meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.~Then 3 months later A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring."
58187|NCT02218268|O2|Outcome|No Meal Bolus Then Pre-meal Bolus|"A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.~Then 3 months later meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring."
58188|NCT02218268|O1|Outcome|Pre-meal Bolus Then No Meal Bolus|"A meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.~Then 3 months later A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring."
58189|NCT02218268|E2|Reported Event|No Meal Bolus Then Pre-meal Bolus|A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring, This is a crossover study and all participants will take place in this arm after 3 months of their visit.
58190|NCT02218268|E1|Reported Event|Pre-meal Bolus Then No Meal Bolus|A meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring. This is a crossover study and all participants will take place in this arm after 3 months of their visit.
58191|NCT02218216|B3|Baseline|Total|Total of all reporting groups
58192|NCT02218216|B2|Baseline|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
58193|NCT02218216|B1|Baseline|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
58194|NCT02218216|P3|Participant Flow|Volunteers|"MRI Diagnostic of Volunteer Controls for Device Calibration~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
58195|NCT02218216|P2|Participant Flow|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
58196|NCT02218216|P1|Participant Flow|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
58197|NCT02218216|O3|Outcome|Volunteers|"MRI Diagnostic of Volunteer Controls for Device Calibration~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
58262|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58198|NCT02218216|O2|Outcome|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
58199|NCT02218216|O1|Outcome|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
58200|NCT02218216|E3|Reported Event|Volunteer Controls|"Non injured volunteers for device calibration~Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
58201|NCT02218216|E2|Reported Event|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
58202|NCT02218216|E1|Reported Event|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
58203|NCT02218203|B1|Baseline|Dextromethorphan/Lidocaine Combination Clinical Trial|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
58204|NCT02218203|P1|Participant Flow|Dextromethorphan/Lidocaine Combination Clinical Trial|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
58205|NCT02218203|O4|Outcome|Dextromethorphan/4mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury. This arm represents an average of all dextromethorphan doses in combination with 4mg/kg Lidocaine.
58206|NCT02218203|O3|Outcome|Dextromethorphan/2mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury. This arm represents an average of all dextromethorphan doses in combination with 2mg/kg Lidocaine.
58207|NCT02218203|O2|Outcome|Dextromethorphan/1mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury. This arm represents an average of all dextromethorphan doses in combination with 1mg/kg Lidocaine.
58208|NCT02218203|O1|Outcome|Dextromethorphan/ 0mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury. This arm represents an average of all dextromethorphan doses in combination with 0mg/kg Lidocaine.
58209|NCT02218203|E16|Reported Event|High Dose Dextromethorphan/4mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
58210|NCT02218203|E15|Reported Event|High Dose Dextromethorphan/2mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
58211|NCT02218203|E14|Reported Event|High Dose Dextromethorphan/1mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
58212|NCT02218203|E13|Reported Event|High Dose Dextromethorphan/0mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
58213|NCT02218203|E12|Reported Event|Medium Dose Dextromethorphan/4mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
58214|NCT02218203|E11|Reported Event|Medium Dose Dextromethorphan/2mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
58215|NCT02218203|E10|Reported Event|Medium Dose Dextromethorphan/1mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
58216|NCT02218203|E9|Reported Event|Medium Dose Dextromethorphan/0mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
58217|NCT02218203|E8|Reported Event|Low Dose Dextromethorphan/4mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
58218|NCT02218203|E7|Reported Event|Low Dose Dextromethorphan/2mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
58219|NCT02218203|E6|Reported Event|Low Dose Dextromethorphan/1mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
58220|NCT02218203|E5|Reported Event|Low Dose Dextromethorphan/0mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
58221|NCT02218203|E4|Reported Event|Placebo Dextromethorphan/4mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
58222|NCT02218203|E3|Reported Event|Placebo Dextromethorphan/2mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
58223|NCT02218203|E2|Reported Event|Placebo Dextromethorphan/1mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
58224|NCT02218203|E1|Reported Event|Placebo Dextromethorphan/0mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
58225|NCT02217982|B3|Baseline|Total|Total of all reporting groups
58226|NCT02217982|B2|Baseline|Treatment Arm|"Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.~Simethicone~Loperamide~Peanut Butter"
58227|NCT02217982|B1|Baseline|Control Group|Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.
58228|NCT02217982|P2|Participant Flow|Treatment Arm|"Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.~Simethicone~Loperamide~Peanut Butter"
58229|NCT02217982|P1|Participant Flow|Control Group|Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.
58611|NCT02215954|O3|Outcome|Treatment Arm [3]: Niflec|"One to two pack(s) on the day of colonoscopy~Niflec"
58230|NCT02217982|O2|Outcome|Treatment Arm|"Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.~Simethicone~Loperamide~Peanut Butter"
58231|NCT02217982|O1|Outcome|Control Group|Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.
58232|NCT02217982|O2|Outcome|Treatment Arm|"Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.~Simethicone~Loperamide~Peanut Butter"
58233|NCT02217982|O1|Outcome|Control Group|Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.
58234|NCT02217982|E2|Reported Event|Treatment Arm|"Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.~Simethicone~Loperamide~Peanut Butter"
58235|NCT02217982|E1|Reported Event|Control Group|Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.
58236|NCT02217878|B3|Baseline|Total|Total of all reporting groups
58237|NCT02217878|B2|Baseline|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58238|NCT02217878|B1|Baseline|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58239|NCT02217878|P2|Participant Flow|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58240|NCT02217878|P1|Participant Flow|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58241|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58242|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58243|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58244|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58245|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58246|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58247|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58248|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58249|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58250|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58251|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58252|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58253|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58254|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58255|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58256|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58257|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58258|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58259|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58260|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58261|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58664|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
58263|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58264|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58265|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58266|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58267|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58268|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58269|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58270|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58271|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58272|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58273|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58274|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58275|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58276|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58277|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58278|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58279|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58280|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58281|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58282|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58283|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58284|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58285|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58286|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58287|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58288|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58289|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58290|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58291|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58292|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58293|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58294|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58295|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58296|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58297|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58298|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58299|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58300|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58301|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58302|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58303|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58304|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58305|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58306|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58307|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58308|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58309|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58310|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58311|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58312|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58313|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58314|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58315|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58316|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58317|NCT02217878|E2|Reported Event|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
58318|NCT02217878|E1|Reported Event|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
58319|NCT02217800|B1|Baseline|Saline, Then DG3173, Then Octreotide|Interventions: saline, DG3173 and octreotide. Eligible patients are to receive a constant 23 hour subcutaneous infusion of saline as placebo comparator and will be randomized in an equal ratio to one of three treatment sequences of doses of 920, 2760 and 5520 µg DG3173 by constant 23 hour subcutaneous infusions in a random sequence followed by three subcutaneous injections of 300 µg octreotide at approximately 8 hour intervals as an active comparator.
58320|NCT02217800|P1|Participant Flow|Saline, Then DG3173, Then Octreotide|Interventions: saline, DG3173 and octreotide. Eligible patients are to receive a constant 23 hour subcutaneous infusion of saline as placebo comparator and will be randomized in an equal ratio to one of three treatment sequences of doses of 920, 2760 and 5520 µg DG3173 by constant 23 hour subcutaneous infusions in a random sequence followed by three subcutaneous injections of 300 µg octreotide at approximately 8 hour intervals as an active comparator.
58321|NCT02217800|O5|Outcome|Active Control (Octreotide)|
58322|NCT02217800|O4|Outcome|5520 µg DG3173|
58323|NCT02217800|O3|Outcome|2760 µg DG3173|
58324|NCT02217800|O2|Outcome|920 µg DG3173|
58325|NCT02217800|O1|Outcome|Saline (Control)|
58326|NCT02217800|E5|Reported Event|Active Control (Octreotide)|
58327|NCT02217800|E4|Reported Event|5520 µg DG3173|
58328|NCT02217800|E3|Reported Event|2760 µg DG3173|
58329|NCT02217800|E2|Reported Event|920 µg DG3173|
58330|NCT02217800|E1|Reported Event|Saline (Control)|
58331|NCT02217280|B1|Baseline|Cervical ESI With Gadolinium|Male and female subjects between the ages of 18-85 with cervical radiculopathy as identified by the study PI. This was a single arm study with a one-time cervical interlaminar injection at the C7-T1 level. A total injection dose of 10.1 ml included 0.1 mL of gadolinium, 2 ml of 10 mg/ml dexamethasone and 8 ml normal saline, which was administered under fluoroscopic guidance.
58332|NCT02217280|P1|Participant Flow|Cervical ESI With Gadolinium|Male and female subjects between the ages of 18-85 with cervical radiculopathy as identified by the study PI. This was a single arm study with a one-time cervical interlaminar injection at the C7-T1 level. A total injection dose of 10.1 ml included 0.1 mL of gadolinium, 2 ml of 10 mg/ml dexamethasone and 8 ml normal saline, which was administered under fluoroscopic guidance.
58333|NCT02217280|O1|Outcome|Cervical ESI|Male and female subjects between the ages of 18-85 with cervical radiculopathy. This was a single arm study.
58334|NCT02217280|O1|Outcome|Injection With Gadolinium|"This group of patients identified by the PI as having cervical radiculopathy will receive gadolinium (the intervention) in their epidural cervical injection along with steroid (DepoMedrol). There is no control group in this study.~Injection with Gadolinium: Gadavist (gadobutrol) injection is a gadolinium-based contrast agent indicated for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system"
58335|NCT02217280|E1|Reported Event|Cervical ESI With Gadolinium|Male and female subjects between the ages of 18-85 with cervical radiculopathy as identified by the study PI. This was a single arm study with a one-time cervical interlaminar injection at the C7-T1 level. A total injection dose of 10.1 ml included 0.1 mL of gadolinium, 2 ml of 10 mg/ml dexamethasone and 8 ml normal saline, which was administered under fluoroscopic guidance.
58336|NCT02216695|B1|Baseline|Acute Kidney Injury|we analysed acute kidney injury requiring dialysis in England
58337|NCT02216695|P1|Participant Flow|Acute Kidney Injury|All patients who had acute kidney injury requiring dialysis between 1998 and 2013 were identified from hospital episode statistic
58338|NCT02216695|O1|Outcome|Acute Kidney Injury Requiring Dialysis|The associations between discharge status was tested with multivariable regression model which included age group and discharge period,
58339|NCT02216695|O1|Outcome|Acute Kidney Injury Requiring Dialysis|Age was categorized into the groups 65, 65–74, 75–84, and > 85. The associations between discharge status was tested with multivariable regression model which included gender, age group, discharge period, admission method, CCS, ethnicity, and AKI in diagnoses code.
58340|NCT02216695|O1|Outcome|Acute Kidney Injury|All patients who had acute kidney injury requiring dialysis between 1998 and 2013 were identified from hospital episode statistic
58341|NCT02216695|O3|Outcome|2008-13|Data during the 15-year period were divided into three 5-year periods (April 1988 to March 2003, April 2003 to March 2008 and April 2008 to March 2013)
58342|NCT02216695|O2|Outcome|2003-08|Data during the 15-year period were divided into three 5-year periods (April 1988 to March 2003, April 2003 to March 2008 and April 2008 to March 2013)
58343|NCT02216695|O1|Outcome|1998-03|All patients who had acute kidney injury and required dialysis between 1998 and 2013 were identified from hospital episode statistic.Data during the 15-year period were divided into three 5-year periods (April 1988 to March 2003, April 2003 to March 2008 and April 2008 to March 2013)
58344|NCT02216695|E1|Reported Event|Dialysis Requiring AKI|AKI patients who required renal replacement therapy
58345|NCT02216591|B3|Baseline|Total|Total of all reporting groups
58346|NCT02216591|B2|Baseline|Control (CON)|"The CON group will also complete 12 total sessions across 6-10 weeks. The same four computer programs from PSSCogRehab 2012, published by Psychological Software Service, will be used in the control group sessions. However, the control program will identify the correct responses to participants, such that they do not need to engage their working memory to answer the questions correctly.~Control (CON)"
58347|NCT02216591|B1|Baseline|Active Cognitive Training (ACT)|"The ACT group will complete 12 individual sessions across 6-10 weeks. Sessions will utilize four commercially available memory-training programs from PSSCogRehab 2012, published by Psychological Software Service. The four programs used will be: (1) Sequence recall of digits - auditory (SRD-A), (2) Sequenced Recall Reversed Digits - Auditory (SRRD-A), (3) Sequenced Recall of Words - Visual (SRW-V), and (4) Verbal memory - categorizing (VM-C). In each training session, participants will complete each of the four memory training programs twice.~Active Cognitive Training (ACT)"
58348|NCT02216591|P2|Participant Flow|Control (CON)|"The CON group will also complete 12 total sessions across 6-10 weeks. The same four computer programs from PSSCogRehab 2012, published by Psychological Software Service, will be used in the control group sessions. However, the control program will identify the correct responses to participants, such that they do not need to engage their working memory to answer the questions correctly.~Control (CON)"
58349|NCT02216591|P1|Participant Flow|Active Cognitive Training (ACT)|"The ACT group will complete 12 individual sessions across 6-10 weeks. Sessions will utilize four commercially available memory-training programs from PSSCogRehab 2012, published by Psychological Software Service. The four programs used will be: (1) Sequence recall of digits - auditory (SRD-A), (2) Sequenced Recall Reversed Digits - Auditory (SRRD-A), (3) Sequenced Recall of Words - Visual (SRW-V), and (4) Verbal memory - categorizing (VM-C). In each training session, participants will complete each of the four memory training programs twice.~Active Cognitive Training (ACT)"
58350|NCT02216591|O2|Outcome|Control (CON)|"The CON group will also complete 12 total sessions across 6-10 weeks. The same four computer programs from PSSCogRehab 2012, published by Psychological Software Service, will be used in the control group sessions. However, the control program will identify the correct responses to participants, such that they do not need to engage their working memory to answer the questions correctly.~Control (CON)"
58351|NCT02216591|O1|Outcome|Active Cognitive Training (ACT)|"The ACT group will complete 12 individual sessions across 6-10 weeks. Sessions will utilize four commercially available memory-training programs from PSSCogRehab 2012, published by Psychological Software Service. The four programs used will be: (1) Sequence recall of digits - auditory (SRD-A), (2) Sequenced Recall Reversed Digits - Auditory (SRRD-A), (3) Sequenced Recall of Words - Visual (SRW-V), and (4) Verbal memory - categorizing (VM-C). In each training session, participants will complete each of the four memory training programs twice.~Active Cognitive Training (ACT)"
58352|NCT02216591|O2|Outcome|Control (CON)|"The CON group will also complete 12 total sessions across 6-10 weeks. The same four computer programs from PSSCogRehab 2012, published by Psychological Software Service, will be used in the control group sessions. However, the control program will identify the correct responses to participants, such that they do not need to engage their working memory to answer the questions correctly.~Control (CON)"
58353|NCT02216591|O1|Outcome|Active Cognitive Training (ACT)|"The ACT group will complete 12 individual sessions across 6-10 weeks. Sessions will utilize four commercially available memory-training programs from PSSCogRehab 2012, published by Psychological Software Service. The four programs used will be: (1) Sequence recall of digits - auditory (SRD-A), (2) Sequenced Recall Reversed Digits - Auditory (SRRD-A), (3) Sequenced Recall of Words - Visual (SRW-V), and (4) Verbal memory - categorizing (VM-C). In each training session, participants will complete each of the four memory training programs twice.~Active Cognitive Training (ACT)"
58354|NCT02216591|O2|Outcome|Control (CON)|"The CON group will also complete 12 total sessions across 6-10 weeks. The same four computer programs from PSSCogRehab 2012, published by Psychological Software Service, will be used in the control group sessions. However, the control program will identify the correct responses to participants, such that they do not need to engage their working memory to answer the questions correctly.~Control (CON)"
58355|NCT02216591|O1|Outcome|Active Cognitive Training (ACT)|"The ACT group will complete 12 individual sessions across 6-10 weeks. Sessions will utilize four commercially available memory-training programs from PSSCogRehab 2012, published by Psychological Software Service. The four programs used will be: (1) Sequence recall of digits - auditory (SRD-A), (2) Sequenced Recall Reversed Digits - Auditory (SRRD-A), (3) Sequenced Recall of Words - Visual (SRW-V), and (4) Verbal memory - categorizing (VM-C). In each training session, participants will complete each of the four memory training programs twice.~Active Cognitive Training (ACT)"
58356|NCT02216591|E2|Reported Event|Control (CON)|"The CON group will also complete 12 total sessions across 6-10 weeks. The same four computer programs from PSSCogRehab 2012, published by Psychological Software Service, will be used in the control group sessions. However, the control program will identify the correct responses to participants, such that they do not need to engage their working memory to answer the questions correctly.~Control (CON)"
58399|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58357|NCT02216591|E1|Reported Event|Active Cognitive Training (ACT)|"The ACT group will complete 12 individual sessions across 6-10 weeks. Sessions will utilize four commercially available memory-training programs from PSSCogRehab 2012, published by Psychological Software Service. The four programs used will be: (1) Sequence recall of digits - auditory (SRD-A), (2) Sequenced Recall Reversed Digits - Auditory (SRRD-A), (3) Sequenced Recall of Words - Visual (SRW-V), and (4) Verbal memory - categorizing (VM-C). In each training session, participants will complete each of the four memory training programs twice.~Active Cognitive Training (ACT)"
58358|NCT02216526|B4|Baseline|Total|Total of all reporting groups
58359|NCT02216526|B3|Baseline|Standard Skin Care|Usual skin care routine of the nursing home resident
58360|NCT02216526|B2|Baseline|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58361|NCT02216526|B1|Baseline|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58362|NCT02216526|P3|Participant Flow|Standard Skin Care|Usual skin care routine of the nursing home resident
58363|NCT02216526|P2|Participant Flow|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58364|NCT02216526|P1|Participant Flow|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58365|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58366|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58367|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58368|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58369|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58370|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58371|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58372|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58373|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58374|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58375|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58376|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58377|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58378|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58379|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58380|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58381|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58382|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58383|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58384|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58385|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58386|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58387|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58388|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58389|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58390|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58391|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58392|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58393|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58394|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58395|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58396|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58397|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58398|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58400|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58401|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58402|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58403|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58404|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58405|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58406|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58407|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58408|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58409|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58410|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58411|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58412|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58413|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58414|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58415|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58416|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58417|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58418|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58419|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58420|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58421|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58422|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58423|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58424|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58425|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58426|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58427|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58428|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58429|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58430|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58431|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58432|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58433|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58434|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58435|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58436|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58437|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58438|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58439|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58440|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58441|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58442|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58443|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58444|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58445|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58446|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58447|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58448|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58449|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58450|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58451|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58452|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58453|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58454|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58455|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58456|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58457|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58458|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58459|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58460|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58461|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58462|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58463|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58464|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58465|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58466|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58467|NCT02216526|O3|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
58468|NCT02216526|O2|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58469|NCT02216526|O1|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58470|NCT02216526|E3|Reported Event|Standard Skin Care|Usual skin care routine of the nursing home resident
58471|NCT02216526|E2|Reported Event|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
58472|NCT02216526|E1|Reported Event|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
58473|NCT02216422|B1|Baseline|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
58474|NCT02216422|P1|Participant Flow|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
58475|NCT02216422|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
58476|NCT02216422|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
58477|NCT02216422|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
58478|NCT02216422|E1|Reported Event|Ombitasvir/Paritaprevir/Ritonavir Plus|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
58479|NCT02216357|B3|Baseline|Total|Total of all reporting groups
58480|NCT02216357|B2|Baseline|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
58481|NCT02216357|B1|Baseline|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
58482|NCT02216357|P2|Participant Flow|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
58608|NCT02215954|O3|Outcome|Treatment Arm [3]: Niflec|"One to two pack(s) on the day of colonoscopy~Niflec"
58483|NCT02216357|P1|Participant Flow|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
58484|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
58485|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
58486|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
58487|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
58488|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
58489|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
58490|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
58491|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
58492|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
58493|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
58494|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
58495|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
58496|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
58497|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
58498|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
58499|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
58500|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
58501|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
58502|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
58503|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
58504|NCT02216357|E2|Reported Event|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
58505|NCT02216357|E1|Reported Event|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
58506|NCT02216123|B3|Baseline|Total|Total of all reporting groups
58507|NCT02216123|B2|Baseline|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
58508|NCT02216123|B1|Baseline|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
58509|NCT02216123|P2|Participant Flow|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
58510|NCT02216123|P1|Participant Flow|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
58511|NCT02216123|O1|Outcome|Participants in TQ Only Arms|TQ only arms
58512|NCT02216123|O1|Outcome|Participants in TQ Only Arms|TQ only arms
58513|NCT02216123|O1|Outcome|Participants With Clinically Relevant Hemolysis|Participants from both treatment arms (TQ + CQ and PQ + CQ) with clinically relevant hemolysis were included.
58514|NCT02216123|O2|Outcome|First Malaria Relapse Follow-up|Participants from all treatment arms (CQ+TQ and PQ+TQ) who had a follow-up visit for relapse episode of malaria were included.
58515|NCT02216123|O1|Outcome|First Malaria Relapse|Participants from all treatment arms (CQ+TQ and PQ+TQ) with a relapse episode of malaria were included.
58516|NCT02216123|O1|Outcome|Participants With Clinically Relevant Hemolysis|Participants from both treatment arms (TQ + CQ and PQ + CQ) with clinically relevant hemolysis were included.
58517|NCT02216123|O2|Outcome|First Malaria Relapse Follow-up|Participants from all treatment arms (CQ+TQ and PQ+TQ) who had a follow-up visit for relapse episode of malaria were included.
58518|NCT02216123|O1|Outcome|First Malaria Relapse|Participants from all treatment arms (CQ+TQ and PQ+TQ) with a relapse episode of malaria were included.
58519|NCT02216123|O1|Outcome|Participants With Clinically Relevant Hemolysis|Participants from both treatment arms (TQ + CQ and PQ + CQ) with clinically relevant hemolysis were included.
58520|NCT02216123|O2|Outcome|First Malaria Relapse Follow-up|Participants from all treatment arms (CQ+TQ and PQ+TQ) who had a follow-up visit for relapse episode of malaria were included.
58521|NCT02216123|O1|Outcome|First Malaria Relapse|Participants from all treatment arms (CQ+TQ and PQ+TQ) with a relapse episode of malaria were included.
58522|NCT02216123|O1|Outcome|Participants With Clinically Relevant Hemolysis|Participants from both treatment arms (TQ + CQ and PQ + CQ) with clinically relevant hemolysis were included.
58523|NCT02216123|O2|Outcome|First Malaria Relapse Follow-up|Participants from all treatment arms (CQ+TQ and PQ+TQ) who had a follow-up visit for relapse episode of malaria were included.
58524|NCT02216123|O1|Outcome|First Malaria Relapse|Participants from all treatment arms (CQ+TQ and PQ+TQ) with a relapse episode of malaria were included.
58525|NCT02216123|O2|Outcome|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
58526|NCT02216123|O1|Outcome|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
58527|NCT02216123|O2|Outcome|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
58528|NCT02216123|O1|Outcome|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
58529|NCT02216123|O2|Outcome|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
58530|NCT02216123|O1|Outcome|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
58531|NCT02216123|O2|Outcome|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
58532|NCT02216123|O1|Outcome|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
58533|NCT02216123|O2|Outcome|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
58534|NCT02216123|O1|Outcome|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
58535|NCT02216123|O2|Outcome|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
58536|NCT02216123|O1|Outcome|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
58537|NCT02216123|O2|Outcome|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
58538|NCT02216123|O1|Outcome|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
58539|NCT02216123|O2|Outcome|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
58540|NCT02216123|O1|Outcome|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
58541|NCT02216123|O2|Outcome|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
58542|NCT02216123|O1|Outcome|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
58543|NCT02216123|O2|Outcome|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
58705|NCT02214277|B4|Baseline|Total|Total of all reporting groups
58544|NCT02216123|O1|Outcome|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
58545|NCT02216123|O2|Outcome|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
58546|NCT02216123|O1|Outcome|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
58547|NCT02216123|O2|Outcome|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
58548|NCT02216123|O1|Outcome|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
58549|NCT02216123|O2|Outcome|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
58550|NCT02216123|O1|Outcome|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
58551|NCT02216123|O2|Outcome|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
58552|NCT02216123|O1|Outcome|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
58553|NCT02216123|O2|Outcome|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
58554|NCT02216123|O1|Outcome|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
58555|NCT02216123|O2|Outcome|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
58556|NCT02216123|O1|Outcome|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
58557|NCT02216123|O2|Outcome|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
58558|NCT02216123|O1|Outcome|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
58559|NCT02216123|O2|Outcome|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
58560|NCT02216123|O1|Outcome|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
58561|NCT02216123|O2|Outcome|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
58562|NCT02216123|O1|Outcome|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
58563|NCT02216123|O2|Outcome|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
58564|NCT02216123|O1|Outcome|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
58565|NCT02216123|O2|Outcome|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
58609|NCT02215954|O2|Outcome|Treatment Arm [2]: FE 999169|"Two sachets on the day before colonoscopy~FE 999169"
58610|NCT02215954|O1|Outcome|Treatment Arm [1]: FE 999169|"One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy~FE 999169"
58566|NCT02216123|O1|Outcome|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
58567|NCT02216123|O2|Outcome|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
58568|NCT02216123|O1|Outcome|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
58569|NCT02216123|O2|Outcome|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
58570|NCT02216123|O1|Outcome|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
58571|NCT02216123|E2|Reported Event|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
58572|NCT02216123|E1|Reported Event|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
58573|NCT02216097|B3|Baseline|Total|Total of all reporting groups
58574|NCT02216097|B2|Baseline|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
58575|NCT02216097|B1|Baseline|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
58576|NCT02216097|P2|Participant Flow|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
58577|NCT02216097|P1|Participant Flow|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
58578|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
58579|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
58580|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
58581|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
58582|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
58583|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
58584|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
58585|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
58586|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
58587|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
58588|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
58589|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
58590|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
58591|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
58592|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
58593|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
58594|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
58595|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
58596|NCT02216097|E2|Reported Event|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
58597|NCT02216097|E1|Reported Event|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
58598|NCT02215954|B4|Baseline|Total|Total of all reporting groups
58599|NCT02215954|B3|Baseline|Treatment Arm [3]: Niflec|"One to two pack(s) on the day of colonoscopy~Niflec"
58600|NCT02215954|B2|Baseline|Treatment Arm [2]: FE 999169|"Two sachets on the day before colonoscopy~FE 999169"
58601|NCT02215954|B1|Baseline|Treatment Arm [1]: FE 999169|"One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy~FE 999169"
58602|NCT02215954|P3|Participant Flow|Treatment Arm [3]: Niflec|"One to two pack(s) on the day of colonoscopy~Niflec"
58603|NCT02215954|P2|Participant Flow|Treatment Arm [2]: FE 999169|"Two sachets on the day before colonoscopy~FE 999169"
58604|NCT02215954|P1|Participant Flow|Treatment Arm [1]: FE 999169|"One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy~FE 999169"
58605|NCT02215954|O3|Outcome|Treatment Arm [3]: Niflec|"One to two pack(s) on the day of colonoscopy~Niflec"
58606|NCT02215954|O2|Outcome|Treatment Arm [2]: FE 999169|"Two sachets on the day before colonoscopy~FE 999169"
58607|NCT02215954|O1|Outcome|Treatment Arm [1]: FE 999169|"One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy~FE 999169"
58612|NCT02215954|O2|Outcome|Treatment Arm [2]: FE 999169|"Two sachets on the day before colonoscopy~FE 999169"
58613|NCT02215954|O1|Outcome|Treatment Arm [1]: FE 999169|"One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy~FE 999169"
58614|NCT02215954|O3|Outcome|Treatment Arm [3]: Niflec|"One to two pack(s) on the day of colonoscopy~Niflec"
58615|NCT02215954|O2|Outcome|Treatment Arm [2]: FE 999169|"Two sachets on the day before colonoscopy~FE 999169"
58616|NCT02215954|O1|Outcome|Treatment Arm [1]: FE 999169|"One sachet of the day before colonoscopy, and another sachet on the day of colonoscopy~FE 999169"
58617|NCT02215954|O3|Outcome|Treatment Arm [3]: Niflec|"One to two pack(s) on the day of colonoscopy~Niflec"
58618|NCT02215954|O2|Outcome|Treatment Arm [2]: FE 999169|"Two sachets on the day before colonoscopy~FE 999169"
58619|NCT02215954|O1|Outcome|Treatment Arm [1]: FE 999169|"One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy~FE 999169"
58620|NCT02215954|E3|Reported Event|Treatment Arm [3]: Niflec|"One to two pack(s) on the day of colonoscopy~Niflec"
58621|NCT02215954|E2|Reported Event|Treatment Arm [2]: FE 999169|"Two sachets on the day before colonoscopy~FE 999169"
58622|NCT02215954|E1|Reported Event|Treatment Arm [1]: FE 999169|"One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy~FE 999169"
58623|NCT02215252|B4|Baseline|Total|Total of all reporting groups
58624|NCT02215252|B3|Baseline|Placebo|Participants received matched placebo oral capsule for 4 weeks.
58625|NCT02215252|B2|Baseline|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
58626|NCT02215252|B1|Baseline|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
58627|NCT02215252|P3|Participant Flow|Placebo|Participants received matched placebo oral capsule for 4 weeks.
58628|NCT02215252|P2|Participant Flow|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
58629|NCT02215252|P1|Participant Flow|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
58630|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
58631|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
58632|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
58633|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
58634|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
58635|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
58636|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
58637|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
58638|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
58639|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
58640|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
58641|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
58642|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
58643|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
58644|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
58645|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
58646|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
58647|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
58648|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
58649|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
58650|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
58651|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
58652|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
58653|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
58654|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
58655|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
58656|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
58657|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
58658|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
58659|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
58660|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
58661|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
58662|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
58663|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
58665|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
58666|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
58667|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
58668|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
58669|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
58670|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
58671|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
58672|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
58673|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
58674|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
58675|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
58676|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
58677|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
58678|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
58679|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
58680|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
58681|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
58682|NCT02215252|E3|Reported Event|Placebo|Participants received matched placebo oral capsule for 4 weeks.
58683|NCT02215252|E2|Reported Event|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
58684|NCT02215252|E1|Reported Event|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
58685|NCT02214615|B3|Baseline|Total|Total of all reporting groups
58686|NCT02214615|B2|Baseline|Placebo the Carbamazepine|"Administered in gradual doses from 100 mg twice a day increasing to no more than 400 mg twice a day if symptoms do not reduce to match dosing with carbamazepine. After 2 weeks of steady dose drug will be tapered down every 3 days.~Placebo: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day. Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
58687|NCT02214615|B1|Baseline|Carbamazepine Then Placebo|"Administered in gradual doses from 100 mg twice a day increasing to no more than 400 mg twice a day if symptoms do not reduce. After 2 weeks of steady dose drug will be tapered down every 3 days.~Carbamazepine: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day.~Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
58688|NCT02214615|P2|Participant Flow|Placebo Then Carbamazepine|"Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce to match dosing with carbamazepine. After 2 weeks of steady dose drug will be tapered down every 3 days.~Placebo: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day. Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
58689|NCT02214615|P1|Participant Flow|Carbamazepine Then Placebo|"Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce. After 2 weeks of steady dose drug will be tapered down every 3 days.~Carbamazepine: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day.~Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
58706|NCT02214277|B3|Baseline|Control Arm|Control Arm patients received TAVR only. Patients enrolled in this arm of the study underwent safety follow-up at discharge, at 30 and at 90 days post-procedure; MRI assessment for efficacy at baseline, 2-7 days and 30 days post-procedure; neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure; neurocognitive evaluation at baseline, 2-7 days (optional), 30 days and 90 days post-procedure; and Quality of Life assessment at baseline, 30 days and 90 days.
60542|NCT02203786|O3|Outcome|Haloperidol - Controls|A total of 15 controls were enrolled in this arm.
58690|NCT02214615|O2|Outcome|Placebo Then Carbamazepine|"Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce to match dosing with carbamazepine. After 2 weeks of steady dose drug will be tapered down every 3 days.~Placebo: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day. Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
58691|NCT02214615|O1|Outcome|Carbamazepine Then Placebo|"Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce. After 2 weeks of steady dose drug will be tapered down every 3 days.~Carbamazepine: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day.~Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
58692|NCT02214615|O2|Outcome|Placebo Then Carbamazepine|"Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce to match dosing with carbamazepine. After 2 weeks of steady dose drug will be tapered down every 3 days.~Placebo: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day. Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
58693|NCT02214615|O1|Outcome|Carbamazepine Then Placebo|"Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce. After 2 weeks of steady dose drug will be tapered down every 3 days.~Carbamazepine: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day.~Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
58694|NCT02214615|E2|Reported Event|Placebo|"Administered in gradual doses from 100 mg twice a day increasing to no more than 400 mg twice a day if symptoms do not reduce to match dosing with carbamazepine. After 2 weeks of steady dose drug will be tapered down every 3 days.~Placebo: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day. Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
58695|NCT02214615|E1|Reported Event|Carbamazepine|"Administered in gradual doses from 100 mg twice a day increasing to no more than 400 mg twice a day if symptoms do not reduce. After 2 weeks of steady dose drug will be tapered down every 3 days.~Carbamazepine: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day.~Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
58696|NCT02214420|B3|Baseline|Total|Total of all reporting groups
58697|NCT02214420|B2|Baseline|SMV+SOF+RBV|"IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day~Simeprevir~Sofosbuvir~Ribavirin"
58698|NCT02214420|B1|Baseline|SMV+SOF|"IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD)~Simeprevir~Sofosbuvir"
58699|NCT02214420|P2|Participant Flow|SMV+SOF+RBV|"IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day~Simeprevir~Sofosbuvir~Ribavirin"
58700|NCT02214420|P1|Participant Flow|SMV+SOF|"IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD)~Simeprevir~Sofosbuvir"
58701|NCT02214420|O2|Outcome|SMV+SOF+RBV|"IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day~Simeprevir~Sofosbuvir~Ribavirin"
58702|NCT02214420|O1|Outcome|SMV+SOF|"IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD)~Simeprevir~Sofosbuvir"
58703|NCT02214420|E2|Reported Event|SMV+SOF+RBV|"IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day~Simeprevir~Sofosbuvir~Ribavirin"
58704|NCT02214420|E1|Reported Event|SMV+SOF|"IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD)~Simeprevir~Sofosbuvir"
58707|NCT02214277|B2|Baseline|Test Arm|Test Arm patients received TAVR and the Sentinel System. Patients enrolled in this arm of the study underwent safety follow-up at discharge, at 30 and at 90 days post-procedure; MRI assessment for efficacy at baseline, 2-7 days and 30 days post-procedure; neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure; neurocognitive evaluation at baseline, 2-7 days (optional), 30 days and 90 days post-procedure; Quality of Life assessment at baseline, 30 days and 90 days; and histopathological evaluation of debris captured in the Sentinel device filters.
58708|NCT02214277|B1|Baseline|Safety Arm|Safety Arm patients received TAVR and the Sentinel System. Patients enrolled in this arm of the study received safety follow-up at discharge, at 30 days and 90 days post-procedure; and neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure.
58709|NCT02214277|P3|Participant Flow|Control Arm|"Control Arm patients received TAVR only. Patients enrolled in this arm of the study underwent safety follow-up at discharge, at 30 and at 90 days post-procedure; MRI assessment for efficacy at baseline, 2-7 days and 30 days post-procedure; neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure; neurocognitive evaluation at baseline, 2-7 days (optional), 30 days and 90 days post-procedure; and Quality of Life assessment at baseline, 30 days and 90 days.~The Control Arm was compared to the Test arm for MRI related endpoints."
58710|NCT02214277|P2|Participant Flow|Test Arm|"Test Arm patients received TAVR and the Sentinel System. Patients enrolled in this arm of the study underwent safety follow-up at discharge, at 30 and at 90 days post-procedure; MRI assessment for efficacy at baseline, 2-7 days and 30 days post-procedure; neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure; neurocognitive evaluation at baseline, 2-7 days (optional), 30 days and 90 days post-procedure; Quality of Life assessment at baseline, 30 days and 90 days; and histopathological evaluation of debris captured in the Sentinel device filters.~The Test Arm was compared to the Control Arm for analysis of MRI related endpoints, and was combined with the Safety Arm for analysis of safety endpoints."
58711|NCT02214277|P1|Participant Flow|Safety Arm|"Safety Arm patients received TAVR and the Sentinel System. Patients enrolled in this arm of the study received safety follow-up at discharge, at 30 days and 90 days post-procedure; and neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure. Safety Arm patients did not receive MRI.~The Safety Arm was combined with the Test Arm for analysis of safety endpoints."
58712|NCT02214277|O1|Outcome|Test Arm|Test Arm patients received TAVR and the Sentinel System. Patients enrolled in this arm of the study underwent safety followup at discharge, at 30 and at 90 days postprocedure; MRI assessment for efficacy at baseline, 2-7 days and 30 days postprocedure; neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure; neurocognitive evaluation at baseline, 2-7 days (optional), 30 days and 90 days postprocedure; Quality of Life assessment at baseline, 30 days and 90 days; and histopathological evaluation of debris captured in the Sentinel device filters.
58713|NCT02214277|O1|Outcome|Safety Cohort|The Safety Cohort is the combination of the Safety and Test Arms.
58714|NCT02214277|O2|Outcome|Control Arm|Control Arm patients received TAVR only. Patients enrolled in this arm of the study underwent safety follow-up at discharge, at 30 and at 90 days post-procedure; MRI assessment for efficacy at baseline, 2-7 days and 30 days post-procedure; neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure; neurocognitive evaluation at baseline, 2-7 days (optional), 30 days and 90 days post-procedure; and Quality of Life assessment at baseline, 30 days and 90 days.
58715|NCT02214277|O1|Outcome|Test Arm|Test Arm patients received TAVR and the Sentinel System. Patients enrolled in this arm of the study underwent safety followup at discharge, at 30 and at 90 days postprocedure; MRI assessment for efficacy at baseline, 2-7 days and 30 days postprocedure; neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure; neurocognitive evaluation at baseline, 2-7 days (optional), 30 days and 90 days postprocedure; Quality of Life assessment at baseline, 30 days and 90 days; and histopathological evaluation of debris captured in the Sentinel device filters.
58716|NCT02214277|E2|Reported Event|Control Arm|Control Arm patients received TAVR only. Patients enrolled in this arm of the study underwent safety follow-up at discharge, at 30 and at 90 days post-procedure.
58717|NCT02214277|E1|Reported Event|Safety Cohort (Test + Safety Arms)|The Safety Cohort is the combination of the Safety and Test Arms. Patients enrolled in these arms of the study underwent safety follow-up at discharge, at 30 and at 90 days post-procedure.
58718|NCT02214238|B3|Baseline|Total|Total of all reporting groups
58719|NCT02214238|B2|Baseline|Modified PAP Device First, Then Market Released PAP Device|Us of the modified PAP device first for 3 week (with a 4 day window) followed by an in lab sleep study. Patient then crossed over to use the market released PAP device for 3 weeks (with a 4 day window) followed by another in lab sleep study.
58720|NCT02214238|B1|Baseline|Market Released PAP Device First, Then Modified PAP Device|Use of a market released PAP device first for 3 week (with a 4 day window) followed by an in lab sleep study. Patient then crossed over to use the modified PAP device for 3 weeks (with a 4 day window) followed by another in lab sleep study.
58721|NCT02214238|P2|Participant Flow|Modified PAP Device First, Then Market Released PAP Device|Use of the modified PAP device first for 3 week (with a 4 day window) followed by an in lab sleep study. Patient then crossed over to use the market released PAP device for 3 weeks (with a 4 day window) followed by another in lab sleep study.
58722|NCT02214238|P1|Participant Flow|Market Released PAP Device First, Then Modified PAP Device|Use of a market released PAP device first for 3 week (with a 4 day window) followed by an in lab sleep study. Patient then crossed over to use the modified PAP device for 3 weeks (with a 4 day window) followed by another in lab sleep study.
58723|NCT02214238|O2|Outcome|Modified PAP Device|"Use of the modified PAP device~PAP device"
58724|NCT02214238|O1|Outcome|Market Released PAP Device|"Use of a market released PAP device~PAP device"
58725|NCT02214238|O2|Outcome|Modified PAP Device|"Use of the modified PAP device~PAP device"
58726|NCT02214238|O1|Outcome|Market Released PAP Device|"Use of a market released PAP device~PAP device"
58727|NCT02214238|O2|Outcome|Modified PAP Device|"Use of the modified PAP device~PAP device"
58728|NCT02214238|O1|Outcome|Market Released PAP Device|"Use of a market released PAP device~PAP device"
58729|NCT02214238|E2|Reported Event|Market Released PAP Device|Use of a market released PAP device for 3 more weeks.
58730|NCT02214238|E1|Reported Event|Modified PAP Device|Use of a modified PAP device for 3 more weeks.
58731|NCT02214225|B4|Baseline|Total|Total of all reporting groups
58732|NCT02214225|B3|Baseline|Trivalent Influenza Vaccine (TIV-2)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).~TIV-2 dose: One 0.5 mL intramuscular dose into the deltoid muscle."
58733|NCT02214225|B2|Baseline|Trivalent Influenza Vaccine (TIV-1)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~TIV-1 dose: One 0.5 mL intramuscular dose into the deltoid muscle."
58734|NCT02214225|B1|Baseline|Quadrivalent Influenza Vaccine (QIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~QIV dose: One 0.5 mL intramuscular dose into the deltoid muscle."
58735|NCT02214225|P3|Participant Flow|Trivalent Influenza Vaccine (TIV-2)|"The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
58736|NCT02214225|P2|Participant Flow|Trivalent Influenza Vaccine (TIV-1)|"The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
58737|NCT02214225|P1|Participant Flow|Quadrivalent Influenza Vaccine (QIV)|"The study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
58738|NCT02214225|O3|Outcome|Trivalent Influenza Vaccine (TIV-2)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
58739|NCT02214225|O2|Outcome|Trivalent Influenza Vaccine (TIV-1)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
58740|NCT02214225|O1|Outcome|Quadrivalent Influenza Vaccine (QIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
58741|NCT02214225|O3|Outcome|Trivalent Influenza Vaccine (TIV-2)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
58742|NCT02214225|O2|Outcome|Trivalent Influenza Vaccine (TIV-1)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
58743|NCT02214225|O1|Outcome|Quadrivalent Influenza Vaccine (QIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
58744|NCT02214225|O3|Outcome|Trivalent Influenza Vaccine (TIV-2)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
58745|NCT02214225|O2|Outcome|Trivalent Influenza Vaccine (TIV-1)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
58746|NCT02214225|O1|Outcome|Quadrivalent Influenza Vaccine (QIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
58747|NCT02214225|O3|Outcome|Trivalent Influenza Vaccine (TIV-2)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
58748|NCT02214225|O2|Outcome|Trivalent Influenza Vaccine (TIV-1)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
58870|NCT02214121|O6|Outcome|Ticagrelor 2.25 mg/kg|Single dose received at Visit 3.
58871|NCT02214121|O5|Outcome|Ticagrelor 1.125 mg/kg|Single dose received at Visit 3.
58749|NCT02214225|O1|Outcome|Quadrivalent Influenza Vaccine (QIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
58750|NCT02214225|O6|Outcome|bioCSL TIV-1 (B/VIC) (≥ 65 Years)|
58751|NCT02214225|O5|Outcome|bioCSL TIV-1 (B/YAM) (≥ 65 Years)|
58752|NCT02214225|O4|Outcome|bioCSL QIV (≥ 65 Years)|
58753|NCT02214225|O3|Outcome|bioCSL TIV-2 (B/VIC) (18 to <65 Years)|
58754|NCT02214225|O2|Outcome|bioCSL TIV-1 (B/YAM) (18 to <65 Years)|
58755|NCT02214225|O1|Outcome|bioCSL QIV (18 to <65 Years)|
58756|NCT02214225|O6|Outcome|bioCSL TIV-1 (B/VIC) (≥ 65 Years)|
58757|NCT02214225|O5|Outcome|bioCSL TIV-1 (B/YAM) (≥ 65 Years)|
58758|NCT02214225|O4|Outcome|bioCSL QIV (≥ 65 Years)|
58759|NCT02214225|O3|Outcome|bioCSL TIV-2 (B/VIC) (18 to <65 Years)|
58760|NCT02214225|O2|Outcome|bioCSL TIV-1 (B/YAM) (18 to <65 Years)|
58761|NCT02214225|O1|Outcome|bioCSL QIV (18 to <65 Years)|
58762|NCT02214225|O6|Outcome|bioCSL TIV-1 (B/VIC) (≥ 65 Years)|
58763|NCT02214225|O5|Outcome|bioCSL TIV-1 (B/YAM) (≥ 65 Years)|
58764|NCT02214225|O4|Outcome|bioCSL QIV (≥ 65 Years)|
58765|NCT02214225|O3|Outcome|bioCSL TIV-2 (B/VIC) (18 to <65 Years)|
58766|NCT02214225|O2|Outcome|bioCSL TIV-1 (B/YAM) (18 to <65 Years)|
58767|NCT02214225|O1|Outcome|bioCSL QIV (18 to <65 Years)|
58768|NCT02214225|O6|Outcome|bioCSL TIV-2 (B/VIC) (≥ 65 Years)|
58769|NCT02214225|O5|Outcome|bioCSL TIV-1 (B/YAM) (≥ 65 Years)|
58770|NCT02214225|O4|Outcome|bioCSL QIV (≥ 65 Years)|
58771|NCT02214225|O3|Outcome|bioCSL TIV-2 (B/VIC) (18 to <65 Years)|
58772|NCT02214225|O2|Outcome|bioCSL TIV-1 (B/YAM) (18 to <65 Years)|
58773|NCT02214225|O1|Outcome|bioCSL QIV (18 to <65 Years)|
58774|NCT02214225|O2|Outcome|SCR: Pooled TIV-1 or TIV-2|"For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.~B/Yamagata serology for TIV-2 (B Victoria), Adults 18 years and older, n=850. B/Victoria serology for TIV-1 (B Yamagata), Adults 18 years and older, n=854. B/Yamagata serology for TIV-2 (B Victoria), Adults 18 to <65 years, n=421. B/Victoria serology for TIV-1 (B Yamagata), Adults 18 years to <65 years, n=424.~B/Yamagata serology for TIV-2 (B Victoria), Adults 65 years and older, n=429. B/Victoria serology for TIV-1 (B Yamagata), Adults 65 years and older, n=430."
58775|NCT02214225|O1|Outcome|SCR: bioCSL QIV|"For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.~bioCSL QIV, Adults 18 years and older, n=1691. bioCSL QIV, Adults 18 years to <65 years, n=835. bioCSL QIV, Adults 65 years and older, n=856."
58776|NCT02214225|O2|Outcome|Postvaccination GMT: TIV-1 (B/YAM) or TIV-2 (B/VIC)|B/Yamagata serology for TIV-2 (B Victoria), Adults 18 years and older, n=850 B/Victoria serology for TIV-1 (B Yamagata), Adults 18 years and older, n=854 B/Yamagata serology for TIV-2 (B Victoria), Adults 18 through 64 years inclusive, n=421 B/Victoria serology for TIV-1 (B Yamagata), Adults 18 through 64 years inclusive, n=424 B/Yamagata serology for TIV-2 (B Victoria), Adults 65 years and older, n=429 B/Victoria serology for TIV-1 (B Yamagata), Adults 65 years and older, n=430.
58777|NCT02214225|O1|Outcome|Postvaccination GMT: bioCSL QIV|bioCSL QIV, Adults 18 years and older, N=1691. 18 to < 65 years, n=835. => 65 years, n=856.
58778|NCT02214225|O4|Outcome|SCR: Pooled TIV (A Strains) or TIV-1 or TIV-2 (≥ 65 Years)|"bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.~bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429."
58779|NCT02214225|O3|Outcome|SCR: bioCSL QIV (≥ 65 Years)|"bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.~bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429."
58780|NCT02214225|O2|Outcome|SCR: Pooled TIV (A Strains) or TIV-1 or TIV-2 (18 to <65years)|"bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.~bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429."
58781|NCT02214225|O1|Outcome|SCR: bioCSL QIV (18 to < 65 Years)|"bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.~bioCSL QIV, n=835. Pooled TIV (A strains), n=845. TIV-1 (B Yamagata), n=424. TIV-2 (B Victoria), n=421."
58782|NCT02214225|O4|Outcome|GMT: Pooled TIV (A Strains) or TIV-1 or TIV-2 (≥ 65 Years)|Postvaccination GMT. Pooled TIV (A strains), n=859 TIV-1 (B/YAM), n=430. TIV-2 (B/VIC), n=429.
58783|NCT02214225|O3|Outcome|GMT: bioCSL QIV (≥ 65 Years)|Postvaccination GMT. bioCSL QIV, n=856.
58784|NCT02214225|O2|Outcome|GMT: Pooled TIV (A Strains) or TIV-1 or TIV-2 (18 to <65years)|Postvaccination GMT. Pooled TIV (A strains), n=845. TIV-1 (B Yamagata), n=424. TIV-2 (B Victoria), n=421.
58785|NCT02214225|O1|Outcome|GMT: bioCSL QIV (18 to <65 Years)|Postvaccination GMT. bioCSL QIV, n=835.
58786|NCT02214225|O2|Outcome|SCR: Pooled TIV (A Strains) or TIV-1 (B/YAM) or TIV-2 (B/VIC)|Pooled TIV (A strains), n=1704. TIV-1 (B Yamagata), n=854. TIV-2 (B Victoria), n=850.
58787|NCT02214225|O1|Outcome|SCR: bioCSL QIV|bioCSL QIV, n=1691.
58788|NCT02214225|O2|Outcome|GMT: Pooled TIV (A Strains) or TIV-1 (B/YAM) or TIV-2 (B/VIC)|"Postvaccination GMT.~Pooled TIV (A strains), N=1704. TIV-1 (B/YAM), N=854. TIV-2 (B/VIC), N=850."
58789|NCT02214225|O1|Outcome|GMT: bioCSL QIV|Postvaccination GMT.
58790|NCT02214225|E3|Reported Event|Trivalent Influenza Vaccine (TIV-2)|"The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
58791|NCT02214225|E2|Reported Event|Trivalent Influenza Vaccine (TIV-1)|"The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
58872|NCT02214121|O4|Outcome|Ticagrelor 0.563 mg/kg|Single dose received at Visit 3
58873|NCT02214121|O3|Outcome|Ticagrelor 0.375 mg/kg|Single dose received at Visit 3.
58792|NCT02214225|E1|Reported Event|Quadrivalent Influenza Vaccine (QIV)|"The study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
58793|NCT02214186|B3|Baseline|Total|Total of all reporting groups
58794|NCT02214186|B2|Baseline|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
58795|NCT02214186|B1|Baseline|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
58796|NCT02214186|P2|Participant Flow|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
58797|NCT02214186|P1|Participant Flow|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
58798|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
58799|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
58800|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
58801|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
58802|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
58803|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
58804|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
58805|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
58806|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
58807|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
58808|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
58809|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
58810|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
58811|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
58812|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
58813|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
58814|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
58815|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
58874|NCT02214121|O2|Outcome|Ticagrelor 0.75 mg/kg|Single dose received at Visit 2.
58875|NCT02214121|O1|Outcome|Ticagrelor 0.125 mg/kg|Single dose received at Visit 2.
58816|NCT02214186|E2|Reported Event|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
58817|NCT02214186|E1|Reported Event|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
58818|NCT02214121|B4|Baseline|Total|Total of all reporting groups
58819|NCT02214121|B3|Baseline|Part B - Placebo|Actual treatment group for Part B of the study. Relevant for the Part B period.
58820|NCT02214121|B2|Baseline|Part B - Ticagrelor|Actual treatment group for Part B of the study. Relevant for the Part B period.
58821|NCT02214121|B1|Baseline|Part A - Ticagrelor|Actual treatment group for Part A of the study. Relevant for the Part A period.
58822|NCT02214121|P3|Participant Flow|Part B - Placebo|Randomised treatment group for Part B of the study. Relevant for the Part B period.
58823|NCT02214121|P2|Participant Flow|Part B - Ticagrelor|Randomised treatment group for Part B of the study. Relevant for the Part B period.
58824|NCT02214121|P1|Participant Flow|Part A - Ticagrelor|Randomised treatment group for Part A of the study. Relevant for the Part A period.
58825|NCT02214121|O2|Outcome|Part B - Placebo|Randomised treatment group for Part B of the study. Relevant for the Part B period.
58826|NCT02214121|O1|Outcome|Part B - Ticagrelor|Randomised treatment group for Part B of the study. Relevant for the Part B period.
58827|NCT02214121|O1|Outcome|Part A - Ticagrelor|Randomised treatment group for Part A of the study. Relevant for the Part A period.
58828|NCT02214121|O2|Outcome|Part B - Placebo|Randomised treatment group for Part B of the study. Relevant for the Part B period.
58829|NCT02214121|O1|Outcome|Part B - Ticagrelor|Randomised treatment group for Part B of the study. Relevant for the Part B period.
58830|NCT02214121|O2|Outcome|Part B - Placebo|Randomised treatment group for Part B of the study. Relevant for the Part B period.
58831|NCT02214121|O1|Outcome|Part B - Ticagrelor|Randomised treatment group for Part B of the study. Relevant for the Part B period.
58832|NCT02214121|O2|Outcome|Part B - Placebo|Randomised treatment group for Part B of the study. Relevant for the Part B period.
58833|NCT02214121|O1|Outcome|Part B - Ticagrelor|Randomised treatment group for Part B of the study. Relevant for the Part B period.
58834|NCT02214121|O2|Outcome|Part B - Placebo|Randomised treatment group for Part B of the study. Relevant for the Part B period.
58835|NCT02214121|O1|Outcome|Part B - Ticagrelor|Randomised treatment group for Part B of the study. Relevant for the Part B period.
58836|NCT02214121|O2|Outcome|Part B - Placebo|Randomised treatment group for Part B of the study. Relevant for the Part B period.
58837|NCT02214121|O1|Outcome|Part B - Ticagrelor|Randomised treatment group for Part B of the study. Relevant for the Part B period.
58838|NCT02214121|O2|Outcome|Part B - Placebo|Randomised treatment group for Part B of the study. Relevant for the Part B period.
58839|NCT02214121|O1|Outcome|Part B - Ticagrelor|Randomised treatment group for Part B of the study. Relevant for the Part B period.
58840|NCT02214121|O2|Outcome|Part B - Placebo|Randomised treatment group for Part B of the study. Relevant for the Part B period.
58841|NCT02214121|O1|Outcome|Part B - Ticagrelor|Randomised treatment group for Part B of the study. Relevant for the Part B period.
58842|NCT02214121|O2|Outcome|Part B - Placebo|Randomised treatment group for Part B of the study. Relevant for the Part B period.
58843|NCT02214121|O1|Outcome|Part B - Ticagrelor|Randomised treatment group for Part B of the study. Relevant for the Part B period.
58844|NCT02214121|O1|Outcome|Ticagrelor 0.125 mg/kg Bid|Repeated bid treatment during Part B.
58845|NCT02214121|O1|Outcome|Overall|All patients receiving Ticagrelor during Part A.
58846|NCT02214121|O1|Outcome|Ticagrelor 0.125 mg/kg Bid|Repeated bid treatment during Part B.
58847|NCT02214121|O9|Outcome|Ticagrelor 0.75 mg/kg Bid|Repeated bid treatment between Visit 3 and Visit 4.
58848|NCT02214121|O8|Outcome|Ticagrelor 0.563 mg/kg Bid|Repeated bid treatment between Visit 3 and Visit 4.
58849|NCT02214121|O7|Outcome|Ticagrelor 0.125 mg/kg Bid|Repeated bid treatment between Visit 3 and Visit 4.
58850|NCT02214121|O6|Outcome|Ticagrelor 2.25 mg/kg|Single dose received at Visit 3.
58851|NCT02214121|O5|Outcome|Ticagrelor 1.125 mg/kg|Single dose received at Visit 3.
58852|NCT02214121|O4|Outcome|Ticagrelor 0.563 mg/kg|Single dose received at Visit 3
58853|NCT02214121|O3|Outcome|Ticagrelor 0.375 mg/kg|Single dose received at Visit 3.
58854|NCT02214121|O2|Outcome|Ticagrelor 0.75 mg/kg|Single dose received at Visit 2.
58855|NCT02214121|O1|Outcome|Ticagrelor 0.125 mg/kg|Single dose received at Visit 2.
58856|NCT02214121|O1|Outcome|Ticagrelor 0.125 mg/kg Bid|Repeated bid treatment during Part B.
58857|NCT02214121|O9|Outcome|Ticagrelor 0.75 mg/kg Bid|Repeated bid treatment between Visit 3 and Visit 4.
58858|NCT02214121|O8|Outcome|Ticagrelor 0.563 mg/kg Bid|Repeated bid treatment between Visit 3 and Visit 4.
58859|NCT02214121|O7|Outcome|Ticagrelor 0.125 mg/kg Bid|Repeated bid treatment between Visit 3 and Visit 4.
58860|NCT02214121|O6|Outcome|Ticagrelor 2.25 mg/kg|Single dose received at Visit 3.
58861|NCT02214121|O5|Outcome|Ticagrelor 1.125 mg/kg|Single dose received at Visit 3.
58862|NCT02214121|O4|Outcome|Ticagrelor 0.563 mg/kg|Single dose received at Visit 3
58863|NCT02214121|O3|Outcome|Ticagrelor 0.375 mg/kg|Single dose received at Visit 3.
58864|NCT02214121|O2|Outcome|Ticagrelor 0.75 mg/kg|Single dose received at Visit 2.
58865|NCT02214121|O1|Outcome|Ticagrelor 0.125 mg/kg|Single dose received at Visit 2.
58866|NCT02214121|O1|Outcome|Ticagrelor 0.125 mg/kg Bid|Repeated bid treatment during Part B.
58867|NCT02214121|O9|Outcome|Ticagrelor 0.75 mg/kg Bid|Repeated bid treatment between Visit 3 and Visit 4.
58868|NCT02214121|O8|Outcome|Ticagrelor 0.563 mg/kg Bid|Repeated bid treatment between Visit 3 and Visit 4.
58869|NCT02214121|O7|Outcome|Ticagrelor 0.125 mg/kg Bid|Repeated bid treatment between Visit 3 and Visit 4.
103222|NCT01963845|O1|Outcome|Placebo|Sitagliptin-matched placebo tablet
58877|NCT02214121|O9|Outcome|Ticagrelor 0.75 mg/kg Bid|Repeated bid treatment between Visit 3 and Visit 4.
58878|NCT02214121|O8|Outcome|Ticagrelor 0.563 mg/kg Bid|Repeated bid treatment between Visit 3 and Visit 4.
58879|NCT02214121|O7|Outcome|Ticagrelor 0.125 mg/kg Bid|Repeated bid treatment between Visit 3 and Visit 4.
58880|NCT02214121|O6|Outcome|Ticagrelor 2.25 mg/kg|Single dose received at Visit 3.
58881|NCT02214121|O5|Outcome|Ticagrelor 1.125 mg/kg|Single dose received at Visit 3.
58882|NCT02214121|O4|Outcome|Ticagrelor 0.563 mg/kg|Single dose received at Visit 3
58883|NCT02214121|O3|Outcome|Ticagrelor 0.375 mg/kg|Single dose received at Visit 3.
58884|NCT02214121|O2|Outcome|Ticagrelor 0.75 mg/kg|Single dose received at Visit 2.
58885|NCT02214121|O1|Outcome|Ticagrelor 0.125 mg/kg|Single dose received at Visit 2.
58886|NCT02214121|O2|Outcome|Placebo|Repeated bid treatment during Part B.
58887|NCT02214121|O1|Outcome|Ticagrelor 0.125 mg/kg Bid|Repeated bid treatment during Part B.
58888|NCT02214121|O9|Outcome|Ticagrelor 0.75 mg/kg Bid|Repeated bid treatment between Visit 3 and Visit 4.
58889|NCT02214121|O8|Outcome|Ticagrelor 0.563 mg/kg Bid|Repeated bid treatment between Visit 3 and Visit 4.
58890|NCT02214121|O7|Outcome|Ticagrelor 0.125 mg/kg Bid|Repeated bid treatment between Visit 3 and Visit 4.
58891|NCT02214121|O6|Outcome|Ticagrelor 2.25 mg/kg|Single dose received at Visit 3.
58892|NCT02214121|O5|Outcome|Ticagrelor 1.125 mg/kg|Single dose received at Visit 3.
58893|NCT02214121|O4|Outcome|Ticagrelor 0.563 mg/kg|Single dose received at Visit 3
58894|NCT02214121|O3|Outcome|Ticagrelor 0.375 mg/kg|Single dose received at Visit 3.
58895|NCT02214121|O2|Outcome|Ticagrelor 0.75 mg/kg|Single dose received at Visit 2.
58896|NCT02214121|O1|Outcome|Ticagrelor 0.125 mg/kg|Single dose received at Visit 2.
58897|NCT02214121|E3|Reported Event|Part B - Placebo|Randomised treatment group for Part B of the study. Relevant for the Part B period.
58898|NCT02214121|E2|Reported Event|Part B - Ticagrelor|Randomised treatment group for Part B of the study. Relevant for the Part B period.
58899|NCT02214121|E1|Reported Event|Part A - Ticagrelor|Randomised treatment group for Part A of the study. Relevant for the Part A period.
58900|NCT02213900|B3|Baseline|Total|Total of all reporting groups
58901|NCT02213900|B2|Baseline|Placebo|"Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.~Placebo"
58902|NCT02213900|B1|Baseline|Haloperidol|"Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.~Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days"
58903|NCT02213900|P2|Participant Flow|Placebo|"Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.~Placebo"
58904|NCT02213900|P1|Participant Flow|Haloperidol|"Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.~Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days"
58905|NCT02213900|O2|Outcome|Placebo|"Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.~Placebo"
58906|NCT02213900|O1|Outcome|Haloperidol|"Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.~Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days"
58907|NCT02213900|O2|Outcome|Placebo|"Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.~Placebo"
58908|NCT02213900|O1|Outcome|Haloperidol|"Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.~Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days"
58909|NCT02213900|O2|Outcome|Placebo|"Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.~Placebo"
58910|NCT02213900|O1|Outcome|Haloperidol|"Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.~Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days"
58911|NCT02213900|O2|Outcome|Placebo|"Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.~Placebo"
58912|NCT02213900|O1|Outcome|Haloperidol|"Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.~Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days"
58913|NCT02213900|E2|Reported Event|Placebo|"Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.~Placebo"
58914|NCT02213900|E1|Reported Event|Haloperidol|"Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.~Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days"
58915|NCT02213666|B1|Baseline|Enrolled Patients|The study sample includes patients referred for a clinically indicated ablation procedure of atrial fibrillation or atrial flutter.
58916|NCT02213666|P1|Participant Flow|Intracardiac and Transesophageal Echocardiography|The study sample includes patients referred for a clinically indicated ablation procedure of atrial fibrillation or atrial flutter.
58917|NCT02213666|O1|Outcome|Enrolled Patients|The study sample includes patients referred for a clinically indicated ablation procedure of atrial fibrillation or atrial flutter.
58918|NCT02213666|E1|Reported Event|Enrolled Patients|The study sample includes patients referred for a clinically indicated ablation procedure of atrial fibrillation or atrial flutter.
58919|NCT02213510|B3|Baseline|Total|Total of all reporting groups
58920|NCT02213510|B2|Baseline|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
58951|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58921|NCT02213510|B1|Baseline|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
58922|NCT02213510|P2|Participant Flow|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
58923|NCT02213510|P1|Participant Flow|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
58924|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
58925|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
58926|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
58927|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
58928|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
58929|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
58930|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
58931|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
58932|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
58933|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
58934|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
58952|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58953|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
61385|NCT02201056|O3|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
58935|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
58936|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
58937|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
58938|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
58939|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
58940|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
58941|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
58942|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
58943|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
58944|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
58945|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
58946|NCT02213510|E2|Reported Event|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
58947|NCT02213510|E1|Reported Event|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
58948|NCT02213250|B1|Baseline|All Participants|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58949|NCT02213250|P2|Participant Flow|BeneFIX 50 IU/kg; Age Group: >=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58950|NCT02213250|P1|Participant Flow|BeneFIX 50 IU/kg; Age Group: >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by intravenous (IV) infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
103223|NCT01963845|E2|Reported Event|Active Drug|Sitagliptin 100 mg
58954|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58955|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58956|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58957|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58958|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58959|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58960|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58961|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58962|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58963|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58964|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58965|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58966|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58967|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58968|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58969|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58970|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58971|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58972|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; Age Group>=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58973|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58974|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58975|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58976|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58977|NCT02213250|E1|Reported Event|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
58978|NCT02213198|B3|Baseline|Total|Total of all reporting groups
58979|NCT02213198|B2|Baseline|Standard Care|"Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.~Standard Care: Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases"
58980|NCT02213198|B1|Baseline|Engagement Focused Care|"Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention~Engagement focused care: Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice."
58981|NCT02213198|P2|Participant Flow|Standard Care|"Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.~Standard Care: Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases"
59016|NCT02212834|B2|Baseline|Breast MRI|Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer
104913|NCT01955564|O1|Outcome|Cohort 1|NW-3509a 1mg, single dose
58982|NCT02213198|P1|Participant Flow|Engagement Focused Care|"Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention~Engagement focused care: Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice."
58983|NCT02213198|O2|Outcome|Standard Care|"Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.~Standard Care: Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases"
58984|NCT02213198|O1|Outcome|Engagement Focused Care|"Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention~Engagement focused care: Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice."
58985|NCT02213198|O2|Outcome|Standard Care|"Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.~Standard Care: Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases"
58986|NCT02213198|O1|Outcome|Engagement Focused Care|"Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention~Engagement focused care: Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice."
58987|NCT02213198|E2|Reported Event|Standard Care|"Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.~Standard Care: Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases"
58988|NCT02213198|E1|Reported Event|Engagement Focused Care|"Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention~Engagement focused care: Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice."
58989|NCT02213055|B3|Baseline|Total|Total of all reporting groups
58990|NCT02213055|B2|Baseline|Standard Head Lice Product|"Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.~Standard head lice product: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products. After a baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may choose and purchase any other head lice treatment of their choice. All treatments (investigational and comparison) are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and at day seven and day fourteen after the first application."
58991|NCT02213055|B1|Baseline|LiceMD|"Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.~LiceMD: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. All participants will be examined for lice count and scalp irritation the day after the first application, and at day seven and day fourteen after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any of these examinations, the school nurse will instruct the parent/guardian to retreat."
58992|NCT02213055|P2|Participant Flow|Standard Head Lice Product|"Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.~Standard Head lice product: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products. After a baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may choose and purchase any other head lice treatment of their choice. All treatments (investigational and comparison) are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven and fourteen days after the first application."
59012|NCT02212977|O1|Outcome|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
59013|NCT02212977|E2|Reported Event|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
59014|NCT02212977|E1|Reported Event|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
58993|NCT02213055|P1|Participant Flow|LICEMD|"Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.~LICEMD: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven and fourteen days after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any of these examinations, the school nurse will instruct the parent/guardian to retreat."
58994|NCT02213055|O2|Outcome|Standard Head Lice Product|"Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.~Standard head lice product: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products. After a baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may choose and purchase any other head lice treatment of their choice. All treatments (investigational and comparison) are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven days and fourteen days after the first application."
58995|NCT02213055|O1|Outcome|LiceMD|"Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.~LICEMD: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven days and fourteen days after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any of these examinations, the school nurse will instruct the parent/guardian to retreat."
58996|NCT02213055|E2|Reported Event|Standard Head Lice Product|"Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.~Standard Head lice product: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products. After a baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may choose and purchase any other head lice treatment of their choice. All treatments (investigational and comparison) are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven and fourteen days after the first application."
58997|NCT02213055|E1|Reported Event|LiceMD|"Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.~LICEMD: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven and fourteen days after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any of these examinations, the school nurse will instruct the parent/guardian to retreat."
58998|NCT02212977|B3|Baseline|Total|Total of all reporting groups
58999|NCT02212977|B2|Baseline|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
59000|NCT02212977|B1|Baseline|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
59001|NCT02212977|P2|Participant Flow|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
59002|NCT02212977|P1|Participant Flow|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
59003|NCT02212977|O2|Outcome|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
59004|NCT02212977|O1|Outcome|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
59005|NCT02212977|O2|Outcome|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
59006|NCT02212977|O1|Outcome|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
59007|NCT02212977|O2|Outcome|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
59008|NCT02212977|O1|Outcome|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
59009|NCT02212977|O2|Outcome|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
59010|NCT02212977|O1|Outcome|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
59011|NCT02212977|O2|Outcome|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
59015|NCT02212834|B3|Baseline|Total|Total of all reporting groups
104914|NCT01955564|O7|Outcome|Cohort 6|NW-3509a 30 mg, single dose
59017|NCT02212834|B1|Baseline|Mammograms|Surveillance mammograms in women with a personal history of breast cancer
59018|NCT02212834|P2|Participant Flow|Breast MRI|Surveillance Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer
59019|NCT02212834|P1|Participant Flow|Mammograms|Surveillance mammograms in women with a personal history of breast cancer
59020|NCT02212834|O2|Outcome|Breast MRI|Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer
59021|NCT02212834|O1|Outcome|Mammograms|Surveillance mammograms in women with a personal history of breast cancer
59022|NCT02212834|E2|Reported Event|Breast MRI|Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer
59023|NCT02212834|E1|Reported Event|Mammograms|Surveillance mammograms in women with a personal history of breast cancer
59024|NCT02212457|B7|Baseline|Total|Total of all reporting groups
59025|NCT02212457|B6|Baseline|ABCWY_0_2_6 Group|Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix® vaccine at Visit Month 1 and Visit Month 12.
59026|NCT02212457|B5|Baseline|ABCWY_0_11 Group|Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix® vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.
59027|NCT02212457|B4|Baseline|ABCWY_0_6 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix® vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.
59028|NCT02212457|B3|Baseline|ABCWY_0_1 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix® vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.
59029|NCT02212457|B2|Baseline|ABCWY_ 0_2 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
59030|NCT02212457|B1|Baseline|rMenB_0_2 Group|Subjects received two injections of Bexsero™ vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
59031|NCT02212457|P6|Participant Flow|ABCWY_0_2_6 Group|Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix® vaccine at Visit Month 1 and Visit Month 12.
59032|NCT02212457|P5|Participant Flow|ABCWY_0_11 Group|Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix® vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.
59033|NCT02212457|P4|Participant Flow|ABCWY_0_6 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix® vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.
59034|NCT02212457|P3|Participant Flow|ABCWY_0_1 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix® vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.
59035|NCT02212457|P2|Participant Flow|ABCWY_ 0_2 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
59036|NCT02212457|P1|Participant Flow|rMenB_0_2 Group|Subjects received two injections of Bexsero™ vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
59037|NCT02212457|O6|Outcome|ABCWY_0_2_6 Group|Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix® vaccine at Visit Month 1 and Visit Month 12.
59038|NCT02212457|O5|Outcome|ABCWY_0_11 Group|Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix® vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.
59039|NCT02212457|O4|Outcome|ABCWY_0_6 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix® vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.
59040|NCT02212457|O3|Outcome|ABCWY_0_1 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix® vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.
59041|NCT02212457|O2|Outcome|ABCWY_ 0_2 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
59042|NCT02212457|O1|Outcome|rMenB_0_2 Group|Subjects received two injections of Bexsero™ vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
59043|NCT02212457|O6|Outcome|ABCWY_0_2_6 Group|Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix® vaccine at Visit Month 1 and Visit Month 12.
59044|NCT02212457|O5|Outcome|ABCWY_0_11 Group|Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix® vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.
59045|NCT02212457|O4|Outcome|ABCWY_0_6 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix® vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.
59046|NCT02212457|O3|Outcome|ABCWY_0_1 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix® vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.
59047|NCT02212457|O2|Outcome|ABCWY_ 0_2 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
59048|NCT02212457|O1|Outcome|rMenB_0_2 Group|Subjects received two injections of Bexsero™ vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
59049|NCT02212457|O6|Outcome|ABCWY_0_2_6 Group|Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix® vaccine at Visit Month 1 and Visit Month 12.
59050|NCT02212457|O5|Outcome|ABCWY_0_11 Group|Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix® vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.
59051|NCT02212457|O4|Outcome|ABCWY_0_6 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix® vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.
59052|NCT02212457|O3|Outcome|ABCWY_0_1 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix® vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.
59218|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
59053|NCT02212457|O2|Outcome|ABCWY_ 0_2 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
59054|NCT02212457|O1|Outcome|rMenB_0_2 Group|Subjects received two injections of Bexsero™ vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
59055|NCT02212457|O6|Outcome|ABCWY_0_2_6 Group|Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix® vaccine at Visit Month 1 and Visit Month 12.
59056|NCT02212457|O5|Outcome|ABCWY_0_11 Group|Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix® vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.
59057|NCT02212457|O4|Outcome|ABCWY_0_6 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix® vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.
59058|NCT02212457|O3|Outcome|ABCWY_0_1 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix® vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.
59059|NCT02212457|O2|Outcome|ABCWY_ 0_2 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
59060|NCT02212457|O1|Outcome|rMenB_0_2 Group|Subjects received two injections of Bexsero™ vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
59061|NCT02212457|O2|Outcome|ABCWY_0_2_6 Group|Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix® vaccine at Visit Month 1 and Visit Month 12.
59062|NCT02212457|O1|Outcome|ABCWY_ 0_2 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
59063|NCT02212457|O2|Outcome|ABCWY_0_2_6 Group|Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix® vaccine at Visit Month 1 and Visit Month 12.
59064|NCT02212457|O1|Outcome|ABCWY_ 0_2 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
59065|NCT02212457|O2|Outcome|rMenB_0_2 Group|Subjects received two injections of Bexsero™ vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
59066|NCT02212457|O1|Outcome|ABCWY_ 0_2 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
59067|NCT02212457|E6|Reported Event|ABCWY_0_2_6 Group|Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix® vaccine at Visit Month 1 and Visit Month 12.
59068|NCT02212457|E5|Reported Event|ABCWY_0_11 Group|Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix® vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.
59069|NCT02212457|E4|Reported Event|ABCWY_0_6 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix® vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.
59070|NCT02212457|E3|Reported Event|ABCWY_0_1 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix® vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.
59071|NCT02212457|E2|Reported Event|ABCWY_ 0_2 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
59072|NCT02212457|E1|Reported Event|rMenB_0_2 Group|Subjects received two injections of Bexsero™ vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
59073|NCT02212301|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least one lens throughout the duration of the study.
59074|NCT02212301|P2|Participant Flow|Lotrafilcon B / Senofilcon A|Subjects that received the lotrafilcon B contact lens in the first period and then received the senofilcon A contact lens in the second period.
59075|NCT02212301|P1|Participant Flow|Senofilcon A/ Lotrafilcon B|Subjects that received the senofilcon A contact lens in the first period and then received the lotrafilcon B contact lens in the second period.
59076|NCT02212301|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens in either the first or second period of the study.
59077|NCT02212301|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A contact lens in either the first or second period of the study.
59078|NCT02212301|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B in either the first or second period of the study.
59079|NCT02212301|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A contact lens in either the first or second period of the study.
59080|NCT02212301|E2|Reported Event|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens in either the first or second period of the study.
59081|NCT02212301|E1|Reported Event|Senofilcon A|Subjects that received the senofilcon A contact lens in either the first or second period of the study.
59082|NCT02212197|B4|Baseline|Total|Total of all reporting groups
59083|NCT02212197|B3|Baseline|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
59084|NCT02212197|B2|Baseline|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
59085|NCT02212197|B1|Baseline|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
59086|NCT02212197|P3|Participant Flow|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
59087|NCT02212197|P2|Participant Flow|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
59088|NCT02212197|P1|Participant Flow|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
59089|NCT02212197|O3|Outcome|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
59219|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
59090|NCT02212197|O2|Outcome|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
59091|NCT02212197|O1|Outcome|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
59092|NCT02212197|O3|Outcome|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
59093|NCT02212197|O2|Outcome|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
59094|NCT02212197|O1|Outcome|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
59095|NCT02212197|O3|Outcome|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
59096|NCT02212197|O2|Outcome|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
59097|NCT02212197|O1|Outcome|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
59098|NCT02212197|O3|Outcome|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
59099|NCT02212197|O2|Outcome|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
59100|NCT02212197|O1|Outcome|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
59101|NCT02212197|O3|Outcome|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
59102|NCT02212197|O2|Outcome|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
59103|NCT02212197|O1|Outcome|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
59104|NCT02212197|O3|Outcome|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
59105|NCT02212197|O2|Outcome|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
59106|NCT02212197|O1|Outcome|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
59107|NCT02212197|E3|Reported Event|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard 7.5 mg on Days 0, 28 and 56.
59108|NCT02212197|E2|Reported Event|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 7.5 mg on Days 0, 28 and 56.
59109|NCT02212197|E1|Reported Event|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 3.75 mg on Days 0, 28 and 56.
59110|NCT02212106|B3|Baseline|Total|Total of all reporting groups
59111|NCT02212106|B2|Baseline|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
59112|NCT02212106|B1|Baseline|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
59113|NCT02212106|P2|Participant Flow|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
59114|NCT02212106|P1|Participant Flow|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
59115|NCT02212106|O2|Outcome|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
59116|NCT02212106|O1|Outcome|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
59117|NCT02212106|O2|Outcome|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
59118|NCT02212106|O1|Outcome|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
61386|NCT02201056|O2|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
59119|NCT02212106|O2|Outcome|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
59120|NCT02212106|O1|Outcome|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
59121|NCT02212106|O2|Outcome|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
59122|NCT02212106|O1|Outcome|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
59123|NCT02212106|O2|Outcome|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
59124|NCT02212106|O1|Outcome|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
59125|NCT02212106|O1|Outcome|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
59126|NCT02212106|O1|Outcome|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
59127|NCT02212106|E2|Reported Event|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
59128|NCT02212106|E1|Reported Event|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
59129|NCT02212028|B3|Baseline|Total|Total of all reporting groups
59130|NCT02212028|B2|Baseline|Prasugrel Tablets|Prasugrel 60 mg loading dose whole tablets
59131|NCT02212028|B1|Baseline|Prasugrel Crush|Prasugrel 60mg loading dose as crushed tablets
59132|NCT02212028|P2|Participant Flow|Prasugrel Tablets|Prasugrel 60 mg loading dose whole tablets
59133|NCT02212028|P1|Participant Flow|Prasugrel Crush|Prasugrel 60mg loading dose as crushed tablets
59134|NCT02212028|O2|Outcome|Prasugrel Tablets|Prasugrel 60 mg loading dose whole tablets
59135|NCT02212028|O1|Outcome|Prasugrel Crush|Prasugrel 60mg loading dose as crushed tablets
59136|NCT02212028|O2|Outcome|Prasugrel Tablets|Prasugrel 60 mg loading dose whole tablets
59137|NCT02212028|O1|Outcome|Prasugrel Crush|Prasugrel 60mg loading dose as crushed tablets
59138|NCT02212028|E2|Reported Event|Prasugrel Tablets|Prasugrel 60 mg loading dose whole tablets
59139|NCT02212028|E1|Reported Event|Prasugrel Crush|Prasugrel 60mg loading dose as crushed tablets
59140|NCT02211534|B3|Baseline|Total|Total of all reporting groups
59141|NCT02211534|B2|Baseline|Sham Pulsed Electromagnetic Field Device|"Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes.~Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device."
59142|NCT02211534|B1|Baseline|Pulsed Electromagnetic Field Device|"Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes.~Pulsed Electromagnetic Field Device (Provant): The PEMF device delivers non-thermal, non-ionizing pulsed electromagnetic energy to the target tissue, using 27.12 megahertz pulses lasting 42 microseconds and delivered 1000 times per second. The system generates an electromagnetic field that is continuously monitored and regulated to ensure consistent dosing. The therapeutic electromagnetic field is delivered by means of an applicator pad that is placed against the treatment site. The active and sham devices will be identical in appearance and all other physical characteristics in order to maintain the masking of the treatment."
59220|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855.
59221|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
59143|NCT02211534|P2|Participant Flow|Sham Pulsed Electromagnetic Field Device|"Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes.~Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device."
59144|NCT02211534|P1|Participant Flow|Pulsed Electromagnetic Field Device|"Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes.~Pulsed Electromagnetic Field Device (Provant): The PEMF device delivers non-thermal, non-ionizing pulsed electromagnetic energy to the target tissue, using 27.12 megahertz pulses lasting 42 microseconds and delivered 1000 times per second. The system generates an electromagnetic field that is continuously monitored and regulated to ensure consistent dosing. The therapeutic electromagnetic field is delivered by means of an applicator pad that is placed against the treatment site. The active and sham devices will be identical in appearance and all other physical characteristics in order to maintain the masking of the treatment."
59145|NCT02211534|O2|Outcome|Sham Pulsed Electromagnetic Field Device|"Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes.~Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device."
59146|NCT02211534|O1|Outcome|Pulsed Electromagnetic Field Device|"Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes.~Pulsed Electromagnetic Field Device (Provant): The PEMF device delivers non-thermal, non-ionizing pulsed electromagnetic energy to the target tissue, using 27.12 megahertz pulses lasting 42 microseconds and delivered 1000 times per second. The system generates an electromagnetic field that is continuously monitored and regulated to ensure consistent dosing. The therapeutic electromagnetic field is delivered by means of an applicator pad that is placed against the treatment site. The active and sham devices will be identical in appearance and all other physical characteristics in order to maintain the masking of the treatment."
59147|NCT02211534|O2|Outcome|Sham Pulsed Electromagnetic Field Device|"Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes.~Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device."
59148|NCT02211534|O1|Outcome|Pulsed Electromagnetic Field Device|"Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes.~Pulsed Electromagnetic Field Device (Provant): The PEMF device delivers non-thermal, non-ionizing pulsed electromagnetic energy to the target tissue, using 27.12 megahertz pulses lasting 42 microseconds and delivered 1000 times per second. The system generates an electromagnetic field that is continuously monitored and regulated to ensure consistent dosing. The therapeutic electromagnetic field is delivered by means of an applicator pad that is placed against the treatment site. The active and sham devices will be identical in appearance and all other physical characteristics in order to maintain the masking of the treatment."
59149|NCT02211534|O2|Outcome|Sham Pulsed Electromagnetic Field Device|"Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes.~Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device."
59150|NCT02211534|O1|Outcome|Pulsed Electromagnetic Field Device|"Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes.~Pulsed Electromagnetic Field Device (Provant): The PEMF device delivers non-thermal, non-ionizing pulsed electromagnetic energy to the target tissue, using 27.12 megahertz pulses lasting 42 microseconds and delivered 1000 times per second. The system generates an electromagnetic field that is continuously monitored and regulated to ensure consistent dosing. The therapeutic electromagnetic field is delivered by means of an applicator pad that is placed against the treatment site. The active and sham devices will be identical in appearance and all other physical characteristics in order to maintain the masking of the treatment."
59151|NCT02211534|O2|Outcome|Sham Pulsed Electromagnetic Field Device|"Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes.~Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device."
59152|NCT02211534|O1|Outcome|Pulsed Electromagnetic Field Device|"Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes.~Pulsed Electromagnetic Field Device (Provant): The PEMF device delivers non-thermal, non-ionizing pulsed electromagnetic energy to the target tissue, using 27.12 megahertz pulses lasting 42 microseconds and delivered 1000 times per second. The system generates an electromagnetic field that is continuously monitored and regulated to ensure consistent dosing. The therapeutic electromagnetic field is delivered by means of an applicator pad that is placed against the treatment site. The active and sham devices will be identical in appearance and all other physical characteristics in order to maintain the masking of the treatment."
59153|NCT02211534|O2|Outcome|Sham Pulsed Electromagnetic Field Device|"Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes.~Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device."
59154|NCT02211534|O1|Outcome|Pulsed Electromagnetic Field Device|"Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes.~Pulsed Electromagnetic Field Device (Provant): The PEMF device delivers non-thermal, non-ionizing pulsed electromagnetic energy to the target tissue, using 27.12 megahertz pulses lasting 42 microseconds and delivered 1000 times per second. The system generates an electromagnetic field that is continuously monitored and regulated to ensure consistent dosing. The therapeutic electromagnetic field is delivered by means of an applicator pad that is placed against the treatment site. The active and sham devices will be identical in appearance and all other physical characteristics in order to maintain the masking of the treatment."
59155|NCT02211534|O2|Outcome|Sham Pulsed Electromagnetic Field Device|"Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes.~Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device."
59186|NCT02210091|O1|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
59187|NCT02210091|O3|Outcome|Full Analysis Set|
59188|NCT02210091|O2|Outcome|6 to <12 Years Old|
59189|NCT02210091|O1|Outcome|<6 Years Old|
59156|NCT02211534|O1|Outcome|Pulsed Electromagnetic Field Device|"Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes.~Pulsed Electromagnetic Field Device (Provant): The PEMF device delivers non-thermal, non-ionizing pulsed electromagnetic energy to the target tissue, using 27.12 megahertz pulses lasting 42 microseconds and delivered 1000 times per second. The system generates an electromagnetic field that is continuously monitored and regulated to ensure consistent dosing. The therapeutic electromagnetic field is delivered by means of an applicator pad that is placed against the treatment site. The active and sham devices will be identical in appearance and all other physical characteristics in order to maintain the masking of the treatment."
59157|NCT02211534|O2|Outcome|Sham Pulsed Electromagnetic Field Device|"Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes.~Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device."
59158|NCT02211534|O1|Outcome|Pulsed Electromagnetic Field Device|"Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes.~Pulsed Electromagnetic Field Device (Provant): The PEMF device delivers non-thermal, non-ionizing pulsed electromagnetic energy to the target tissue, using 27.12 megahertz pulses lasting 42 microseconds and delivered 1000 times per second. The system generates an electromagnetic field that is continuously monitored and regulated to ensure consistent dosing. The therapeutic electromagnetic field is delivered by means of an applicator pad that is placed against the treatment site. The active and sham devices will be identical in appearance and all other physical characteristics in order to maintain the masking of the treatment."
59159|NCT02211534|O2|Outcome|Sham Pulsed Electromagnetic Field Device|"Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes.~Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device."
59160|NCT02211534|O1|Outcome|Pulsed Electromagnetic Field Device|"Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes.~Pulsed Electromagnetic Field Device (Provant): The PEMF device delivers non-thermal, non-ionizing pulsed electromagnetic energy to the target tissue, using 27.12 megahertz pulses lasting 42 microseconds and delivered 1000 times per second. The system generates an electromagnetic field that is continuously monitored and regulated to ensure consistent dosing. The therapeutic electromagnetic field is delivered by means of an applicator pad that is placed against the treatment site. The active and sham devices will be identical in appearance and all other physical characteristics in order to maintain the masking of the treatment."
59161|NCT02211534|E2|Reported Event|Sham Pulsed Electromagnetic Field Device|"Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes.~Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device."
59162|NCT02211534|E1|Reported Event|Pulsed Electromagnetic Field Device|"Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes.~Pulsed Electromagnetic Field Device (Provant): The PEMF device delivers non-thermal, non-ionizing pulsed electromagnetic energy to the target tissue, using 27.12 megahertz pulses lasting 42 microseconds and delivered 1000 times per second. The system generates an electromagnetic field that is continuously monitored and regulated to ensure consistent dosing. The therapeutic electromagnetic field is delivered by means of an applicator pad that is placed against the treatment site. The active and sham devices will be identical in appearance and all other physical characteristics in order to maintain the masking of the treatment."
59163|NCT02210208|B1|Baseline|All Participants|"All participants were enrolled into part A where the subjects were treated with Mepitel Ag on a surgical burn wound. Then, eligible subjects from part A, had skin from a Donor site to help the burn wound heal. The Donor site was also treated and these patients were included i part B."
59164|NCT02210208|P1|Participant Flow|Overall Study|Mepitel® Ag treatment on graft covered wounds 25 patients. Mepilex® Transfer Ag treatment on donor site 19 patients
59165|NCT02210208|O1|Outcome|Part B: Mepilex Transfer Ag|Mepilex Transfer Ag treatment at donor site for skin graft.
59166|NCT02210208|O1|Outcome|Mepitel Ag|Mepitel Ag treatment on skin graft over surgical burn wounds.
59167|NCT02210208|O1|Outcome|Part B: Mepilex Transfer Ag|Mepilex Transfer Ag treatment at donor site for skin graft.
59168|NCT02210208|O1|Outcome|Part A: Mepitel Ag|"Mepitel Ag treatment on burn wounds with skin grafts~Mepitel Ag"
59169|NCT02210208|E1|Reported Event|Overall Study|Mepitel Ag treatment and Mepilex Transfer Ag
59170|NCT02210195|B3|Baseline|Total|Total of all reporting groups
59171|NCT02210195|B2|Baseline|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
59172|NCT02210195|B1|Baseline|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
59173|NCT02210195|P2|Participant Flow|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
59174|NCT02210195|P1|Participant Flow|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
59175|NCT02210195|O2|Outcome|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
59176|NCT02210195|O1|Outcome|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
59177|NCT02210195|O2|Outcome|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
59178|NCT02210195|O1|Outcome|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
59179|NCT02210195|E2|Reported Event|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
59180|NCT02210195|E1|Reported Event|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
59181|NCT02210091|B3|Baseline|Total|Total of all reporting groups
59182|NCT02210091|B2|Baseline|6 to <12 Years Old|
59183|NCT02210091|B1|Baseline|<6 Years Old|
59184|NCT02210091|P2|Participant Flow|6 to <12 Years Old|
59185|NCT02210091|P1|Participant Flow|<6 Years Old|
59190|NCT02210091|O3|Outcome|Full Analysis Set|
59193|NCT02210091|O3|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
59194|NCT02210091|O2|Outcome|PK Analysis Set - 6 to <12 Years Old|Participants 6 to <12 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmcokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
59195|NCT02210091|O1|Outcome|PK Analysis Set - <6 Years Old|Participants <6 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
59196|NCT02210091|O3|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
59197|NCT02210091|O2|Outcome|PK Analysis Set - 6 to <12 Years Old|Participants 6 to <12 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmcokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
59198|NCT02210091|O1|Outcome|PK Analysis Set <6 Years Old|Participants <6 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
59199|NCT02210091|O3|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
59200|NCT02210091|O2|Outcome|PK Analysis Set - 6 to <12 Years Old|Participants 6 to <12 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmcokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
59201|NCT02210091|O1|Outcome|PK Analysis Set - <6 Years Old|Participants <6 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
59202|NCT02210091|O3|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
59203|NCT02210091|O2|Outcome|PK Analysis Set - 6 to <12 Years Old|Participants 6 to <12 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmcokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
59204|NCT02210091|O1|Outcome|PK Analysis Set - <6 Years Old|Participants <6 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
59205|NCT02210091|O3|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
59206|NCT02210091|O2|Outcome|PK Analysis Set - 6 to <12 Years Old|Participants 6 to <12 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmcokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
59207|NCT02210091|O1|Outcome|PK Analysis Set - <6 Years Old|Participants <6 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
59208|NCT02210091|O1|Outcome|Overall Study Arm|
59209|NCT02210091|O3|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
59210|NCT02210091|O2|Outcome|PK Analysis Set - 6 to <12 Years Old|Participants 6 to <12 years olde who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmcokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
59211|NCT02210091|O1|Outcome|PK Analysis Set - <6 Years Old|Participants <6 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
59212|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
59213|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
59214|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855.
59215|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
59216|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
59217|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855.
104915|NCT01955564|O6|Outcome|Cohort 5|NW-3509a 20 mg, single dose
59222|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
59223|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855.
59224|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
59225|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
59226|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855.
59227|NCT02210091|O3|Outcome|Full Analysis Set|Participants who received at least one dose of BAX 855.
59228|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
59229|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855.
59230|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
59231|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
59232|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
59233|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
59234|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
59235|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
59236|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
59237|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
59238|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
59239|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
59240|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
59241|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
59242|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
59243|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
59244|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
59245|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
59246|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
59247|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
59248|NCT02210091|O3|Outcome|Full Analysis Set|Participants who received at least one dose of BAX 855 in either the Pharmacokinetic (PK) part of the study or the prophylaxis part of the study.
59249|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855 in either the Pharmacokinetic (PK) part of the study or the prophylaxis part of the study.
59250|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855 in either the Pharmacokinetic (PK) part of the study or the prophylaxis part of the study.
59251|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
59252|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
59253|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
59254|NCT02210091|E2|Reported Event|ADVATE Received Before BAX 855|Participants who received at least 1 dose of ADVATE prior to receiving BAX 855 in the PK part of the study.
59255|NCT02210091|E1|Reported Event|BAX 855 Safety Analysis Set|Participants who received at least 1 dose of BAX 855.
59256|NCT02210052|B1|Baseline|Radiofrequency Neurotomy Subjects|Subjects with spinal hardware that are undergoing radiofrequency ablation procedures will have an additional radiofrequency cannula placed at the site of adjacent pedicle screws for temperature measurement only.
59257|NCT02210052|P1|Participant Flow|Radiofrequency Neurotomy Subjects|Subjects with spinal hardware that are undergoing radiofrequency ablation procedures will have an additional radiofrequency cannula placed at the site of adjacent pedicle screws for temperature measurement only.
59258|NCT02210052|O1|Outcome|Radiofrequency Neurotomy Subjects|Subjects with spinal hardware that are undergoing radiofrequency ablation procedures will have an additional radiofrequency cannula placed at the site of adjacent pedicle screws for temperature measurement only.
59259|NCT02210052|E1|Reported Event|Radiofrequency Neurotomy Subjects|Subjects with spinal hardware that are undergoing radiofrequency ablation procedures will have an additional radiofrequency cannula placed at the site of adjacent pedicle screws for temperature measurement only.
59260|NCT02210000|B3|Baseline|Total|Total of all reporting groups
59261|NCT02210000|B2|Baseline|PLACEBO|Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
59262|NCT02210000|B1|Baseline|CAMICINAL 25 MG|Eligible participants received oral Camicinal 25 mg once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
59263|NCT02210000|P2|Participant Flow|PLACEBO|Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
59264|NCT02210000|P1|Participant Flow|CAMICINAL 25 MG|Eligible participants received oral Camicinal 25 milligrams (mg) once daily in the morning with 100 milliliter (mL) of water up to 84 days and were followed-up for 2 weeks.
59265|NCT02210000|O2|Outcome|PLACEBO|Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
59266|NCT02210000|O1|Outcome|CAMICINAL 25 MG|Eligible participants received oral Camicinal 25 mg once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
59315|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59267|NCT02210000|O2|Outcome|PLACEBO|Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
59268|NCT02210000|O1|Outcome|CAMICINAL 25 MG|Eligible participants received oral Camicinal 25 mg once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
59269|NCT02210000|O2|Outcome|PLACEBO|Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
59270|NCT02210000|O1|Outcome|CAMICINAL 25 MG|Eligible participants received oral Camicinal 25 mg once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
59271|NCT02210000|O2|Outcome|PLACEBO|Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
59272|NCT02210000|O1|Outcome|CAMICINAL 25 MG|Eligible participants received oral Camicinal 25 mg once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
59273|NCT02210000|O2|Outcome|PLACEBO|Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
59274|NCT02210000|O1|Outcome|CAMICINAL 25 MG|Eligible participants received oral Camicinal 25 mg once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
59275|NCT02210000|O2|Outcome|PLACEBO|Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
59276|NCT02210000|O1|Outcome|CAMICINAL 25 MG|Eligible participants received oral Camicinal 25 mg once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
59277|NCT02210000|O2|Outcome|PLACEBO|Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
59278|NCT02210000|O1|Outcome|CAMICINAL 25 MG|Eligible participants received oral Camicinal 25 mg once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
59279|NCT02210000|O2|Outcome|PLACEBO|Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
59280|NCT02210000|O1|Outcome|CAMICINAL 25 MG|Eligible participants received oral Camicinal 25 mg once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
59281|NCT02210000|O2|Outcome|PLACEBO|Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
59282|NCT02210000|O1|Outcome|CAMICINAL 25 MG|Eligible participants received oral Camicinal 25 mg once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
59283|NCT02210000|E2|Reported Event|PLACEBO|Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
59284|NCT02210000|E1|Reported Event|CAMICINAL 25 MG|Eligible participants received oral Camicinal 25 mg once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
59285|NCT02209766|B5|Baseline|Total|Total of all reporting groups
59286|NCT02209766|B4|Baseline|Placebo Japanese|Single dose followed by once daily for 14 consecutive days
59287|NCT02209766|B3|Baseline|4 g D5884 Caucasian|Single dose followed by once daily for 14 consecutive days
59288|NCT02209766|B2|Baseline|4 g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59289|NCT02209766|B1|Baseline|2 g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59290|NCT02209766|P5|Participant Flow|4g D5884 Caucasian|Single dose followed by once daily for 14 consecutive days
59291|NCT02209766|P4|Participant Flow|4g D5844 Japanese Placebo|Single dose followed by once daily for 14 consecutive days
59292|NCT02209766|P3|Participant Flow|4 g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59293|NCT02209766|P2|Participant Flow|2 g D5884 Japanese Placebo|Single dose followed by once daily for 14 consecutive days
59294|NCT02209766|P1|Participant Flow|2 g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59295|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
59296|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59297|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59298|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
59299|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59300|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59301|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
59302|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59303|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59304|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
59305|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59306|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59307|NCT02209766|O4|Outcome|Placebo Japanese|Single dose followed by once daily for 14 consecutive days
59308|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
59309|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59310|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59311|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
59312|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59313|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59314|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
59317|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
59318|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59319|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59320|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
59321|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59322|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59323|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
59324|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59325|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59326|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
59327|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59328|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59329|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
59330|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59331|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59332|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
59333|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59334|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
59335|NCT02209766|E4|Reported Event|Placebo Japanese|Single dose followed by once daily for 14 consecutive days
59336|NCT02209766|E3|Reported Event|4 g D4884 Caucasian|
59337|NCT02209766|E2|Reported Event|4 g D4884 Japanese|
59338|NCT02209766|E1|Reported Event|2 g D4884 Japanese|
59339|NCT02209506|B6|Baseline|Total|Total of all reporting groups
59340|NCT02209506|B5|Baseline|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59341|NCT02209506|B4|Baseline|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59342|NCT02209506|B3|Baseline|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59343|NCT02209506|B2|Baseline|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59344|NCT02209506|B1|Baseline|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59345|NCT02209506|P5|Participant Flow|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59346|NCT02209506|P4|Participant Flow|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59347|NCT02209506|P3|Participant Flow|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59348|NCT02209506|P2|Participant Flow|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59349|NCT02209506|P1|Participant Flow|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59350|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59351|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59352|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59353|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59354|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59355|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59356|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59357|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59358|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59359|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59360|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59361|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59362|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59363|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59364|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59365|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59366|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59367|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59368|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59369|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59370|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59371|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59372|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59373|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59374|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59375|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59376|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59377|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59378|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59379|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59380|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59381|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59382|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59383|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59384|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59385|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59386|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59387|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59388|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59389|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59390|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59391|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59392|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59393|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59394|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59395|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59396|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59397|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59398|NCT02209506|O5|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59399|NCT02209506|O4|Outcome|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59400|NCT02209506|O3|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59401|NCT02209506|O2|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59402|NCT02209506|O1|Outcome|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59403|NCT02209506|O5|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59404|NCT02209506|O4|Outcome|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59405|NCT02209506|O3|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59406|NCT02209506|O2|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59407|NCT02209506|O1|Outcome|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59408|NCT02209506|O5|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59409|NCT02209506|O4|Outcome|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59410|NCT02209506|O3|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59411|NCT02209506|O2|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59412|NCT02209506|O1|Outcome|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59413|NCT02209506|O5|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59414|NCT02209506|O4|Outcome|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59415|NCT02209506|O3|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59416|NCT02209506|O2|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59417|NCT02209506|O1|Outcome|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59418|NCT02209506|E5|Reported Event|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59419|NCT02209506|E4|Reported Event|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59420|NCT02209506|E3|Reported Event|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59421|NCT02209506|E2|Reported Event|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59422|NCT02209506|E1|Reported Event|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
59423|NCT02209454|B1|Baseline|Entire Study Population|Includes groups randomized to receive 25mg DKP.TRIS tablet first and 25mg DKP.TRIS oral solution first.
59424|NCT02209454|P2|Participant Flow|Test IMP First, Then Reference IMP|25mg DKP.TRIS oral solution one single administration in first period and 25mg DKP.TRIS tablet one single administration in second period (after washout period).
59425|NCT02209454|P1|Participant Flow|Reference IMP First, Then Test IMP|25mg DKP.TRIS tablet one single administration in first period and 25mg DKP.TRIS oral solution one single administration in second period (after washout period).
59426|NCT02209454|O2|Outcome|Keral® Tablet|"25mg DKP.TRIS tablet~Keral® tablet: One dose of 25 mg DKP tablet"
59427|NCT02209454|O1|Outcome|Enantyum® Oral Solution|"25mg DKP.TRIS oral solution~Enantyum® oral solution: One dose of 25 mg DKP oral solution"
59428|NCT02209454|O2|Outcome|Keral® Tablet|"25mg DKP.TRIS tablet~Keral® tablet: One dose of 25 mg DKP tablet"
59429|NCT02209454|O1|Outcome|Enantyum® Oral Solution|"25mg DKP.TRIS oral solution~Enantyum® oral solution: One dose of 25 mg DKP oral solution"
59430|NCT02209454|O2|Outcome|Keral® Tablet|"25mg DKP.TRIS tablet~Keral® tablet: One dose of 25 mg DKP tablet"
59431|NCT02209454|O1|Outcome|Enantyum® Oral Solution|"25mg DKP.TRIS oral solution~Enantyum® oral solution: One dose of 25 mg DKP oral solution"
59432|NCT02209454|O2|Outcome|Keral® Tablet|"25mg DKP.TRIS tablet~Keral® tablet: One dose of 25 mg DKP tablet"
59433|NCT02209454|O1|Outcome|Enantyum® Oral Solution|"25mg DKP.TRIS oral solution~Enantyum® oral solution: One dose of 25 mg DKP oral solution"
59434|NCT02209454|O2|Outcome|Keral® Tablet|"25mg DKP.TRIS tablet~Keral® tablet: One dose of 25 mg DKP tablet"
59435|NCT02209454|O1|Outcome|Enantyum® Oral Solution|"25mg DKP.TRIS oral solution~Enantyum® oral solution: One dose of 25 mg DKP oral solution"
59436|NCT02209454|E2|Reported Event|Keral® Tablet|"25mg DKP.TRIS tablet~Keral® tablet: One dose of 25 mg DKP tablet"
61388|NCT02201056|O7|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
59437|NCT02209454|E1|Reported Event|Enantyum® Oral Solution|"25mg DKP.TRIS oral solution~Enantyum® oral solution: One dose of 25 mg DKP oral solution"
59438|NCT02209259|B4|Baseline|Total|Total of all reporting groups
59439|NCT02209259|B3|Baseline|Control|The third group (the control arm) will not complete the PCS.
59440|NCT02209259|B2|Baseline|Positively-adjusted PCS|The second intervention group will be comprised of patients who will complete a positively-adjusted version of the PCS.
59441|NCT02209259|B1|Baseline|Standard PCS|The first intervention group will be comprised of patients who will complete the standard PCS.
59442|NCT02209259|P3|Participant Flow|Control|The third group (the control arm) will not complete the PCS.
59443|NCT02209259|P2|Participant Flow|Positively-adjusted PCS|The second intervention group will be comprised of patients who will complete a positively-adjusted version of the PCS.
59444|NCT02209259|P1|Participant Flow|Standard PCS|The first intervention group will be comprised of patients who will complete the standard PCS.
59445|NCT02209259|O3|Outcome|Control|The third group (the control arm) will not complete the PCS.
59446|NCT02209259|O2|Outcome|Positively-adjusted PCS|The second intervention group will be comprised of patients who will complete a positively-adjusted version of the PCS.
59447|NCT02209259|O1|Outcome|Standard PCS|The first intervention group will be comprised of patients who will complete the standard PCS.
59448|NCT02209259|O3|Outcome|Control|The third group (the control arm) will not complete the PCS.
59449|NCT02209259|O2|Outcome|Positively-adjusted PCS|The second intervention group will be comprised of patients who will complete a positively-adjusted version of the PCS.
59450|NCT02209259|O1|Outcome|Standard PCS|The first intervention group will be comprised of patients who will complete the standard PCS.
59451|NCT02209259|O3|Outcome|Control|The third group (the control arm) will not complete the PCS.
59452|NCT02209259|O2|Outcome|Positively-adjusted PCS|The second intervention group will be comprised of patients who will complete a positively-adjusted version of the PCS.
59453|NCT02209259|O1|Outcome|Standard PCS|The first intervention group will be comprised of patients who will complete the standard PCS.
59454|NCT02209259|E3|Reported Event|Control|The third group (the control arm) will not complete the PCS.
59455|NCT02209259|E2|Reported Event|Positively-adjusted PCS|The second intervention group will be comprised of patients who will complete a positively-adjusted version of the PCS.
59456|NCT02209259|E1|Reported Event|Standard PCS|The first intervention group will be comprised of patients who will complete the standard PCS.
59457|NCT02209181|B5|Baseline|Total|Total of all reporting groups
59458|NCT02209181|B4|Baseline|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59459|NCT02209181|B3|Baseline|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59460|NCT02209181|B2|Baseline|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59461|NCT02209181|B1|Baseline|Placebo|Three placebo capsules taken orally
59462|NCT02209181|P4|Participant Flow|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59463|NCT02209181|P3|Participant Flow|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59464|NCT02209181|P2|Participant Flow|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59465|NCT02209181|P1|Participant Flow|Placebo|Three placebo capsules taken orally
59466|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59467|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59468|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59469|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59470|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59471|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59472|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59473|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59474|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59475|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59476|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59477|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59478|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59479|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59480|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59481|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59482|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59483|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59484|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59485|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59486|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59487|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59488|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59489|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
61389|NCT02201056|O6|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
59490|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59491|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59492|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59493|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59494|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59495|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59496|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59497|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59498|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59499|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59500|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59501|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59502|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59503|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59504|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59505|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59506|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59507|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59508|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59509|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59510|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59511|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59512|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59513|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59514|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59515|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59516|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59517|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59518|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59519|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59520|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59521|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59522|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59523|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59524|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59525|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59526|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59527|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59528|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59529|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59530|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59531|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59532|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59533|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59534|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59535|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59536|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59537|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59538|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59539|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59540|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59541|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59542|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59543|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59544|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59545|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
104916|NCT01955564|O5|Outcome|Cohort 4|NW-3509a 10 mg, single dose
59546|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59547|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59548|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59549|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59550|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59551|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59552|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59553|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59554|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59555|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59556|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59557|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59558|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59559|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59560|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59561|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59562|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59563|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59564|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59565|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59566|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59567|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59568|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59569|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59570|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59571|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59572|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59573|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59574|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59575|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59576|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59577|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59578|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59579|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59580|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59581|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59582|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59583|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59584|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59585|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59586|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59587|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59588|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59589|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59590|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59591|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59592|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59593|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59594|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59595|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59596|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59597|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59598|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59599|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59600|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59601|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
104917|NCT01955564|O4|Outcome|Cohort 3|NW-3509a 5mg, single dose
59602|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59603|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59604|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59605|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59606|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59607|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59608|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59609|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59610|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59611|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59612|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59613|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59614|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59615|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59616|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59617|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59618|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59619|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59620|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59621|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
59622|NCT02209181|E4|Reported Event|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
59623|NCT02209181|E3|Reported Event|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
59624|NCT02209181|E2|Reported Event|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
59625|NCT02209181|E1|Reported Event|Placebo|Three placebo capsules taken orally
59626|NCT02209064|B1|Baseline|EpiAccess|"EpiAccess will be used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.~Pericardial access: Access to the pericardium to enable further treatments."
59627|NCT02209064|P1|Participant Flow|EpiAccess|"EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.~Pericardial access: Access to the pericardium to enable further treatments."
59628|NCT02209064|O1|Outcome|EpiAccess|"EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.~Pericardial access: Access to the pericardium to enable further treatments."
59629|NCT02209064|O1|Outcome|EpiAccess|"EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.~Pericardial access: Access to the pericardium to enable further treatments."
59630|NCT02209064|O1|Outcome|EpiAccess|"EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.~Pericardial access: Access to the pericardium to enable further treatments."
59631|NCT02209064|O1|Outcome|EpiAccess|"EpiAccess will be used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.~Pericardial access: Access to the pericardium to enable further treatments."
59632|NCT02209064|E1|Reported Event|EpiAccess|"EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.~Pericardial access: Access to the pericardium to enable further treatments."
59633|NCT02208310|B3|Baseline|Total|Total of all reporting groups
59634|NCT02208310|B2|Baseline|High Dose Vitamin D|"Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if <50 ng/ml, a 30 day course will be administered.~Cholecalciferol 10,000 IU"
59635|NCT02208310|B1|Baseline|Low Dose Vitamin D|"Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.~Cholecalciferol 400 IU"
59636|NCT02208310|P2|Participant Flow|High Dose Vitamin D|"Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if <50 ng/ml, a 30 day course will be administered.~Cholecalciferol 10,000 IU"
59637|NCT02208310|P1|Participant Flow|Low Dose Vitamin D|"Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.~Cholecalciferol 400 IU"
59638|NCT02208310|O2|Outcome|High Dose Vitamin D|"Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if <50 ng/ml, a 30 day course will be administered.~Cholecalciferol 10,000 IU"
59680|NCT02207907|B2|Baseline|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
104918|NCT01955564|O3|Outcome|Cohort 2|NW-3509a 2mg, single dose
59639|NCT02208310|O1|Outcome|Low Dose Vitamin D|"Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.~Cholecalciferol 400 IU"
59640|NCT02208310|O2|Outcome|High Dose Vitamin D|"Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if <50 ng/ml, a 30 day course will be administered.~Cholecalciferol 10,000 IU"
59641|NCT02208310|O1|Outcome|Low Dose Vitamin D|"Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.~Cholecalciferol 400 IU"
59642|NCT02208310|O2|Outcome|High Dose Vitamin D|"Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if <50 ng/ml, a 30 day course will be administered.~Cholecalciferol 10,000 IU"
59643|NCT02208310|O1|Outcome|Low Dose Vitamin D|"Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.~Cholecalciferol 400 IU"
59644|NCT02208310|O2|Outcome|High Dose Vitamin D|"Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if <50 ng/ml, a 30 day course will be administered.~Cholecalciferol 10,000 IU"
59645|NCT02208310|O1|Outcome|Low Dose Vitamin D|"Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.~Cholecalciferol 400 IU"
59646|NCT02208310|O2|Outcome|High Dose Vitamin D|"Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if <50 ng/ml, a 30 day course will be administered.~Cholecalciferol 10,000 IU"
59647|NCT02208310|O1|Outcome|Low Dose Vitamin D|"Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.~Cholecalciferol 400 IU"
59648|NCT02208310|O2|Outcome|High Dose Vitamin D|"Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if <50 ng/ml, a 30 day course will be administered.~Cholecalciferol 10,000 IU"
59649|NCT02208310|O1|Outcome|Low Dose Vitamin D|"Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.~Cholecalciferol 400 IU"
59650|NCT02208310|O2|Outcome|High Dose Vitamin D|"Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if <50 ng/ml, a 30 day course will be administered.~Cholecalciferol 10,000 IU"
59651|NCT02208310|O1|Outcome|Low Dose Vitamin D|"Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.~Cholecalciferol 400 IU"
59652|NCT02208310|O2|Outcome|High Dose Vitamin D|"Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if <50 ng/ml, a 30 day course will be administered.~Cholecalciferol 10,000 IU"
59653|NCT02208310|O1|Outcome|Low Dose Vitamin D|"Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.~Cholecalciferol 400 IU"
59654|NCT02208310|O2|Outcome|High Dose Vitamin D|"Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if <50 ng/ml, a 30 day course will be administered.~Cholecalciferol 10,000 IU"
59655|NCT02208310|O1|Outcome|Low Dose Vitamin D|"Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.~Cholecalciferol 400 IU"
59656|NCT02208310|O2|Outcome|High Dose Vitamin D|"Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if <50 ng/ml, a 30 day course will be administered.~Cholecalciferol 10,000 IU"
59657|NCT02208310|O1|Outcome|Low Dose Vitamin D|"Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.~Cholecalciferol 400 IU"
59658|NCT02208310|O2|Outcome|High Dose Vitamin D|"Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if <50 ng/ml, a 30 day course will be administered.~Cholecalciferol 10,000 IU"
59659|NCT02208310|O1|Outcome|Low Dose Vitamin D|"Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.~Cholecalciferol 400 IU"
104919|NCT01955564|O2|Outcome|Cohort 1|NW-3509a - 1mg, single dose
59660|NCT02208310|O2|Outcome|High Dose Vitamin D|"Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if <50 ng/ml, a 30 day course will be administered.~Cholecalciferol 10,000 IU"
59661|NCT02208310|O1|Outcome|Low Dose Vitamin D|"Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.~Cholecalciferol 400 IU"
59662|NCT02208310|O2|Outcome|High Dose Vitamin D|"Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if <50 ng/ml, a 30 day course will be administered.~Cholecalciferol 10,000 IU"
59663|NCT02208310|O1|Outcome|Low Dose Vitamin D|"Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.~Cholecalciferol 400 IU"
59664|NCT02208310|E2|Reported Event|High Dose Vitamin D|"Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if <50 ng/ml, a 30 day course will be administered.~Cholecalciferol 10,000 IU"
59665|NCT02208310|E1|Reported Event|Low Dose Vitamin D|"Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.~Cholecalciferol 400 IU"
59666|NCT02207972|B3|Baseline|Total|Total of all reporting groups
59667|NCT02207972|B2|Baseline|No Ultrasound Used|"Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml~No ultrasound used: Palpation of anatomical landmarks is used for placement of labor analgesia"
59668|NCT02207972|B1|Baseline|Use of Ultrasound|"Woman requests epidural for pain relief Ultrasound guided CSE placed Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml~Use of Ultrasound: The ultrasound imaging of the lumbar spine in different scanning planes facilitates the identification of the landmarks necessary for appropriate epidural space location in pregnant patients. There are two acoustic windows that are effective for lumbar spine sonographic assessment: one seen on the transverse approach, and the other seen on the longitudinal paramedian approach. The ultrasound single-screen method using the transverse approach of the lumbar spine provides reliable information regarding the landmarks required for labor epidurals. The correct interspace and midline position are identified for correct placement of the CSE analgesia."
59669|NCT02207972|P2|Participant Flow|No Ultrasound Used|"Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml~No ultrasound used: Palpation of anatomical landmarks is used for placement of labor analgesia"
59670|NCT02207972|P1|Participant Flow|Use of Ultrasound|"Woman requests epidural for pain relief Ultrasound guided CSE placed Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml~Use of Ultrasound: The ultrasound imaging of the lumbar spine in different scanning planes facilitates the identification of the landmarks necessary for appropriate epidural space location in pregnant patients. There are two acoustic windows that are effective for lumbar spine sonographic assessment: one seen on the transverse approach, and the other seen on the longitudinal paramedian approach. The ultrasound single-screen method using the transverse approach of the lumbar spine provides reliable information regarding the landmarks required for labor epidurals. The correct interspace and midline position are identified for correct placement of the CSE analgesia."
59671|NCT02207972|O2|Outcome|No Ultrasound Used|"Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml~No ultrasound used: Palpation of anatomical landmarks is used for placement of labor analgesia"
59672|NCT02207972|O1|Outcome|Use of Ultrasound|"Woman requests epidural for pain relief Ultrasound guided CSE placed~Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml~Use of Ultrasound: The ultrasound imaging of the lumbar spine in different scanning planes."
59673|NCT02207972|O2|Outcome|No Ultrasound Used|"Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml~No ultrasound used: Palpation of anatomical landmarks is used for placement of labor analgesia"
59674|NCT02207972|O1|Outcome|Use of Ultrasound|"Woman requests epidural for pain relief Ultrasound guided CSE placed~Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml~Use of Ultrasound: The ultrasound imaging of the lumbar spine in different scanning planes."
59675|NCT02207972|O2|Outcome|No Ultrasound Used|"Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml~No ultrasound used: Palpation of anatomical landmarks is used for placement of labor analgesia"
59676|NCT02207972|O1|Outcome|Use of Ultrasound|"Woman requests epidural for pain relief Ultrasound guided CSE placed~Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml~Use of Ultrasound: The ultrasound imaging of the lumbar spine in different scanning planes"
59677|NCT02207972|E2|Reported Event|No Ultrasound Used|"Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks~Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml~No ultrasound used: Palpation of anatomical landmarks is used for placement of labor analgesia"
59678|NCT02207972|E1|Reported Event|Use of Ultrasound|"Woman requests epidural for pain relief Ultrasound guided CSE placed~Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml~Use of Ultrasound: The ultrasound imaging of the lumbar spine in different scanning planes."
59679|NCT02207907|B3|Baseline|Total|Total of all reporting groups
59681|NCT02207907|B1|Baseline|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
59682|NCT02207907|P2|Participant Flow|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
59683|NCT02207907|P1|Participant Flow|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
59684|NCT02207907|O2|Outcome|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
59685|NCT02207907|O1|Outcome|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
59686|NCT02207907|O2|Outcome|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
59687|NCT02207907|O1|Outcome|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
59688|NCT02207907|O2|Outcome|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
59689|NCT02207907|O1|Outcome|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
59690|NCT02207907|O2|Outcome|0% Sodium Bicarbonate|Toothpaste containing 1100 ppm fluoride as sodium fluoride
59691|NCT02207907|O1|Outcome|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
59692|NCT02207907|O2|Outcome|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
59693|NCT02207907|O1|Outcome|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
59694|NCT02207907|O2|Outcome|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
59695|NCT02207907|O1|Outcome|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
59696|NCT02207907|E2|Reported Event|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
59697|NCT02207907|E1|Reported Event|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
59698|NCT02207829|B3|Baseline|Total|Total of all reporting groups
59699|NCT02207829|B2|Baseline|Tiotropium 18 mcg+Placebo QD|Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.
59700|NCT02207829|B1|Baseline|Umeclidinium 62.5 mcg+Placebo QD|Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
59701|NCT02207829|P2|Participant Flow|Tiotropium 18 mcg+Placebo QD|Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.
59702|NCT02207829|P1|Participant Flow|Umeclidinium 62.5 mcg+Placebo QD|Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
59703|NCT02207829|O2|Outcome|Tiotropium 18 mcg+Placebo QD|Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.
59704|NCT02207829|O1|Outcome|Umeclidinium 62.5 mcg+Placebo QD|Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
59705|NCT02207829|E2|Reported Event|Tiotropium 18 mcg+Placebo QD|Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.
59706|NCT02207829|E1|Reported Event|Umeclidinium 62.5 mcg+Placebo QD|Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
59707|NCT02207803|B3|Baseline|Total|Total of all reporting groups
59708|NCT02207803|B2|Baseline|Control|Group receiving the standard of care at the rehabilitation facility
59709|NCT02207803|B1|Baseline|Transition Assistance Program|Group receiving the 5-session behavioral treatment from a clinician
59710|NCT02207803|P2|Participant Flow|Control|Group receiving the standard of care at the rehabilitation facility
59711|NCT02207803|P1|Participant Flow|Transition Assistance Program|Group receiving the 5-session behavioral treatment from a clinician
59712|NCT02207803|O2|Outcome|Control|Group receiving the standard of care at the rehabilitation facility
59713|NCT02207803|O1|Outcome|Transition Assistance Program|Group receiving the 5-session behavioral treatment from a clinician
59714|NCT02207803|O2|Outcome|Control|Group receiving the standard of care at the rehabilitation facility
104920|NCT01955564|O1|Outcome|Placebo|Placebo, single dose
59715|NCT02207803|O1|Outcome|Transition Assistance Program|Group receiving the 5-session behavioral treatment from a clinician
59716|NCT02207803|E2|Reported Event|Control|Group receiving the standard of care at the rehabilitation facility
59717|NCT02207803|E1|Reported Event|Transition Assistance Program|Group receiving the 5-session behavioral treatment from a clinician
59718|NCT02207634|B3|Baseline|Total|Total of all reporting groups
59719|NCT02207634|B2|Baseline|Evolocumab|Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study.
59720|NCT02207634|B1|Baseline|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. Participants continued with their background statin therapy during the course of the study.
59721|NCT02207634|P2|Participant Flow|Evolocumab|Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study.
59722|NCT02207634|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. Participants continued with their background statin therapy during the course of the study.
59723|NCT02207634|O2|Outcome|Evolocumab|Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study.
59724|NCT02207634|O1|Outcome|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. Participants continued with their background statin therapy during the course of the study.
59725|NCT02207634|O2|Outcome|Evolocumab|Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study.
59726|NCT02207634|O1|Outcome|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. Participants continued with their background statin therapy during the course of the study.
59727|NCT02207634|O2|Outcome|Evolocumab|Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study.
59728|NCT02207634|O1|Outcome|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. Participants continued with their background statin therapy during the course of the study.
59729|NCT02207634|O2|Outcome|Evolocumab|Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study.
59730|NCT02207634|O1|Outcome|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. Participants continued with their background statin therapy during the course of the study.
59731|NCT02207634|E2|Reported Event|Evolocumab|Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study.
59732|NCT02207634|E1|Reported Event|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. Participants continued with their background statin therapy during the course of the study.
59733|NCT02207621|B4|Baseline|Total|Total of all reporting groups
59734|NCT02207621|B3|Baseline|AR-13324 Ophthalmic Solution 0.02% BID|1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
59735|NCT02207621|B2|Baseline|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
59736|NCT02207621|B1|Baseline|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) and 1 drop placebo in the morning (AM) in both eyes (OU)
59737|NCT02207621|P3|Participant Flow|AR-13324 Ophthalmic Solution 0.02% BID|1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
59738|NCT02207621|P2|Participant Flow|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
59739|NCT02207621|P1|Participant Flow|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) and 1 drop placebo in the morning (AM) in both eyes (OU)
59740|NCT02207621|O3|Outcome|AR-13324 Ophthalmic Solution 0.02% BID|1 drop AR-13324 BID in the AM and PM, OU
59741|NCT02207621|O2|Outcome|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop Timolol maleate BID in the AM and PM, OU
59742|NCT02207621|O1|Outcome|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the PM and 1 drop placebo in the AM in both eyes
59743|NCT02207621|O3|Outcome|AR-13324 Ophthalmic Solution 0.02% BID|1 drop AR-13324 BID in the AM and PM, OU
59744|NCT02207621|O2|Outcome|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop Timolol maleate BID in the AM and PM, OU
59745|NCT02207621|O1|Outcome|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the PM & 1 drop placebo in the AM, OU
59746|NCT02207621|E3|Reported Event|AR-13324 Ophthalmic Solution 0.02% BID|1 drop AR-13324 BID in the AM and PM, OU
59747|NCT02207621|E2|Reported Event|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop Timolol maleate BID in the AM and PM, OU
59748|NCT02207621|E1|Reported Event|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the PM and 1 drop placebo in the AM, OU
59749|NCT02207608|B3|Baseline|Total|Total of all reporting groups
59750|NCT02207608|B2|Baseline|Hyaluronic Acid|"Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).~Hyaluronic Acid~BCG (Immucist®)"
59751|NCT02207608|B1|Baseline|BCG Alone (Immucist®)|"Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone~BCG (Immucist®)"
59752|NCT02207608|P2|Participant Flow|Hyaluronic Acid|"Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).~Hyaluronic Acid~BCG (Immucist®)"
104921|NCT01955564|E7|Reported Event|Cohort 6|NW-3509a 30 mg, single dose
59753|NCT02207608|P1|Participant Flow|BCG Alone (Immucist®)|"Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone~BCG (Immucist®)"
59754|NCT02207608|O2|Outcome|Hyaluronic Acid|"Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).~Hyaluronic Acid~BCG (Immucist®)"
59755|NCT02207608|O1|Outcome|BCG Alone (Immucist®)|"Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone~BCG (Immucist®)"
59756|NCT02207608|E2|Reported Event|Hyaluronic Acid|"Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).~Hyaluronic Acid~BCG (Immucist®)"
59757|NCT02207608|E1|Reported Event|BCG Alone (Immucist®)|"Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone~BCG (Immucist®)"
59758|NCT02207569|B1|Baseline|CoreValve Evolut R TAVR System|"The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components: >~Evolut R Transcatheter Aortic Valve (TAV) >~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath >~EnVeo R Loading System (LS) > > CoreValve Evolut R TAVR system"
59759|NCT02207569|P1|Participant Flow|CoreValve Evolut R TAVR System|"The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)~>~> CoreValve Evolut R TAVR system"
59760|NCT02207569|O1|Outcome|CoreValve Evolut R TAVR System|"The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)~>~> CoreValve Evolut R TAVR system"
59761|NCT02207569|O1|Outcome|CoreValve Evolut R TAVR System|"The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)~>~> CoreValve Evolut R TAVR system"
59762|NCT02207569|O1|Outcome|CoreValve Evolut R TAVR System|"The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)~>~> CoreValve Evolut R TAVR system"
59763|NCT02207569|O1|Outcome|CoreValve Evolut R TAVR System|"The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)~>~> CoreValve Evolut R TAVR system"
59764|NCT02207569|O1|Outcome|CoreValve Evolut R TAVR System|"The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)~>~> CoreValve Evolut R TAVR system"
59765|NCT02207569|O1|Outcome|CoreValve Evolut R TAVR System|"The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)~>~> CoreValve Evolut R TAVR system"
59766|NCT02207569|O1|Outcome|CoreValve Evolut R TAVR System|"The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)~>~> CoreValve Evolut R TAVR system"
59767|NCT02207569|O1|Outcome|CoreValve Evolut R TAVR System|"The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)~>~> CoreValve Evolut R TAVR system"
59768|NCT02207569|O1|Outcome|CoreValve Evolut R TAVR System|"The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)~>~> CoreValve Evolut R TAVR system"
59769|NCT02207569|O1|Outcome|CoreValve Evolut R TAVR System|"The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)~>~> CoreValve Evolut R TAVR system"
59770|NCT02207569|O1|Outcome|CoreValve Evolut R TAVR System|"The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)~>~> CoreValve Evolut R TAVR system"
59771|NCT02207569|O1|Outcome|CoreValve Evolut R TAVR System|"The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)~>~> CoreValve Evolut R TAVR system"
59772|NCT02207569|O1|Outcome|CoreValve Evolut R TAVR System|"The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)~>~> CoreValve Evolut R TAVR system"
59773|NCT02207569|O1|Outcome|CoreValve Evolut R TAVR System|"The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)~>~> CoreValve Evolut R TAVR system"
59774|NCT02207569|O1|Outcome|CoreValve Evolut R TAVR System|"The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)~>~> CoreValve Evolut R TAVR system"
59775|NCT02207569|E1|Reported Event|CoreValve Evolut R TAVR System|"The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut R Transcatheter Aortic Valve (TAV) EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath EnVeo R Loading System (LS)"
59776|NCT02207491|B3|Baseline|Total|Total of all reporting groups
59777|NCT02207491|B2|Baseline|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
59778|NCT02207491|B1|Baseline|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
59779|NCT02207491|P2|Participant Flow|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
59780|NCT02207491|P1|Participant Flow|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
59781|NCT02207491|O2|Outcome|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
59782|NCT02207491|O1|Outcome|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
59783|NCT02207491|O2|Outcome|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
59784|NCT02207491|O1|Outcome|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
59785|NCT02207491|E2|Reported Event|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
59786|NCT02207491|E1|Reported Event|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
59787|NCT02207478|B3|Baseline|Total|Total of all reporting groups
59788|NCT02207478|B2|Baseline|GS-TBLB-X-ray Group|"The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
59789|NCT02207478|B1|Baseline|ENB-GS-TBLB-X-ray Group|"The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
59790|NCT02207478|P2|Participant Flow|GS-TBLB-X-ray Group|"The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
59791|NCT02207478|P1|Participant Flow|ENB-GS-TBLB-X-ray Group|"The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System.~ENB: ENB is performed using an electromagnetic navigation system (LK-DW-NK-Z; Suzhou Lungcare Medical Technology Inc., China) with an internal locatable guide (LG; Lungcare) with diameter of 1.45 mm. Bronchoscopes with a working channel diameter of 2.0 mm are used (BF-260 and BF-P260F; Olympus, Japan). The LG is inserted into the GS(K-201; Olympus) beforehand, and the GS-covered LG is introduced via the working channel of the bronchoscope and navigated to the PPL finally. The LG and GS are confirmed to reach the lesion by radiograph fluoroscopy.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
59792|NCT02207478|O2|Outcome|GS-TBLB-X-ray Group|"The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
59793|NCT02207478|O1|Outcome|ENB-GS-TBLB-X-ray Group|"The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
59794|NCT02207478|O2|Outcome|GS-TBLB-X-ray Group|"The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
59795|NCT02207478|O1|Outcome|ENB-GS-TBLB-X-ray Group|"The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
59796|NCT02207478|E2|Reported Event|GS-TBLB-X-ray Group|"The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
59797|NCT02207478|E1|Reported Event|ENB-GS-TBLB-X-ray Group|"The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
59798|NCT02207413|B7|Baseline|Total|Total of all reporting groups
61390|NCT02201056|O5|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
59799|NCT02207413|B6|Baseline|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59800|NCT02207413|B5|Baseline|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59801|NCT02207413|B4|Baseline|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59802|NCT02207413|B3|Baseline|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59803|NCT02207413|B2|Baseline|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59804|NCT02207413|B1|Baseline|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59805|NCT02207413|P6|Participant Flow|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59806|NCT02207413|P5|Participant Flow|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59807|NCT02207413|P4|Participant Flow|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59808|NCT02207413|P3|Participant Flow|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59809|NCT02207413|P2|Participant Flow|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59810|NCT02207413|P1|Participant Flow|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59811|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59909|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm)fluoride as sodium fluoride
59812|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59813|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59814|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59815|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59816|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59817|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59818|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59819|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59820|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59821|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59884|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-4y Group|Subjects in the Influsplit Tetra_IP group aged between 3 to 4 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59822|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59823|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59824|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59825|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6m-<5y Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to <5 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59826|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6m-<5y Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to <5 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59827|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59828|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59829|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59830|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59831|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59901|NCT02207413|E2|Reported Event|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59910|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
59832|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59833|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59834|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59835|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59836|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59837|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59838|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59839|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59840|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59841|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59842|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59911|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm fluoride as sodium fluoride
61391|NCT02201056|O4|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
59843|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59844|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59845|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59846|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59847|NCT02207413|O2|Outcome|Influsplit Tetra_LP 5-17y Group|Subjects in the Influsplit Tetra_LP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59848|NCT02207413|O1|Outcome|Influsplit Tetra_IP 5-17y Group|Subjects in the Influsplit Tetra_IP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59849|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59850|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59851|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59852|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59853|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59854|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59855|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59856|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59857|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59902|NCT02207413|E1|Reported Event|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59903|NCT02207400|B3|Baseline|Total|Total of all reporting groups
59858|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59859|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59860|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59861|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59862|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59863|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59864|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59865|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59866|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59867|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59868|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59869|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59870|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59904|NCT02207400|B2|Baseline|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
59905|NCT02207400|B1|Baseline|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride
59906|NCT02207400|P2|Participant Flow|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
59871|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59872|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59873|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59874|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59875|NCT02207413|O2|Outcome|Influsplit Tetra_LP 5-17y Group|Subjects in the Influsplit Tetra_LP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59876|NCT02207413|O1|Outcome|Influsplit Tetra_IP 5-17y Group|Subjects in the Influsplit Tetra_IP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59877|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-4y Group|Subjects in the Influsplit Tetra_LP group aged between 3 to 4 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59878|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-4y Group|Subjects in the Influsplit Tetra_IP group aged between 3 to 4 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59879|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59880|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59881|NCT02207413|O2|Outcome|Influsplit Tetra_LP 5-17y Group|Subjects in the Influsplit Tetra_LP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59882|NCT02207413|O1|Outcome|Influsplit Tetra_IP 5-17y Group|Subjects in the Influsplit Tetra_IP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59883|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-4y Group|Subjects in the Influsplit Tetra_LP group aged between 3 to 4 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59907|NCT02207400|P1|Participant Flow|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride
59885|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59886|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59887|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59888|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59889|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59890|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59891|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59892|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59893|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59894|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59895|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59896|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
59897|NCT02207413|E6|Reported Event|Influsplit Tetra_LP 6-35 m|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59898|NCT02207413|E5|Reported Event|Influsplit Tetra_IP 6-35 m|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
59899|NCT02207413|E4|Reported Event|Influsplit Tetra_LP 3-17 y|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59900|NCT02207413|E3|Reported Event|Influsplit Tetra_IP 3-17 y|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
59908|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
59912|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
59913|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride
59914|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
59915|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride
59916|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
59917|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride
59918|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
59919|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride
59920|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
59921|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
59922|NCT02207400|E2|Reported Event|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
59923|NCT02207400|E1|Reported Event|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm fluoride as sodium fluoride
59924|NCT02207244|B4|Baseline|Total|Total of all reporting groups
59925|NCT02207244|B3|Baseline|Adalimumab|Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and thereafter through week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12.
59926|NCT02207244|B2|Baseline|Guselkumab 100 mg|Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5, and q2w thereafter through Week 15.
59927|NCT02207244|B1|Baseline|Placebo|Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.
59928|NCT02207244|P9|Participant Flow|Adalimumab (Week 28 - 48)|Participants who were assigned to the adalimumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and 32 and q8w thereafter through Week 48 and placebo matched to guselkumab SC injection at Weeks 36 and 44. Participants who were PASI 90 responders, received placebo matched to guselkumab subcutaneous injection q4w thereafter through Week 48 or until loss of >=50% in the improvement in PASI. If they lost response according to this definition, they were treated with guselkumab.
59929|NCT02207244|P8|Participant Flow|Guselkumab 100 mg (Week 28 - 48)|Participants assigned to the guselkumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 44 and placebo matched to guselkumab at Weeks 32, 40 and 48. Participants who were PASI 90 responders were rerandomized to either guselkumab or placebo. Participants rerandomized to guselkumab, received guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 44 and placebo matched to guselkumab SC injection at Weeks 32, 40 and 48. Participants rerandomized to placebo, received placebo matched to guselkumab SC injection q4w through Week 48 or until loss of >=50% in the improvement in PASI. If they lost response according to this definition, they were retreated with guselkumab.
59930|NCT02207244|P7|Participant Flow|Placebo Then Guselkumab 100 mg (Week 28 - 48)|Participants assigned to the placebo, then guselkumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders received guselkumab 100 mg SC injection at Week 28 and then every 8 weeks (q8w) thereafter through Week 44 and placebo matched to guselkumab SC injection at Weeks 32, 40 and 48. Participants who were PASI 90 responders at Week 28 received placebo matched to guselkumab SC injection at Week 28 and every 4 weeks (q4w) thereafter through Week 48 or until loss of greater than or equal to (>=) 50 percentage (%) in the improvement in PASI. If they lost response according to this definition, they were retreated with guselkumab.
59931|NCT02207244|P6|Participant Flow|Adalimumab (Week 16 - 28)|Participants who received adalimumab in the first period, continued to receive adalimumab 40 mg (1 SC injection) every 2 weeks (q2w) from Week 17 through Week 23 and placebo matched to guselkumab SC injection at Weeks 16 and 20.
59932|NCT02207244|P5|Participant Flow|Guselkumab 100 mg (Week 16 - 28)|Participants who started receiving guselkumab in the first period, received placebo matched to guselkumab SC injection at Week 16 followed by guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21 and 23.
59933|NCT02207244|P4|Participant Flow|Placebo Then Guselkumab 100 mg (Week 16 - 28)|Participants who started receiving placebo in the first period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21, and 23 during the active comparator controlled period (ACP).
59934|NCT02207244|P3|Participant Flow|Adalimumab (Week 0 - 16)|Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Week 1 and every other week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12 during PCP.
59935|NCT02207244|P2|Participant Flow|Guselkumab 100 mg (Week 0 - 16)|Participants received guselkumab 100 milligram (mg) SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 followed by placebo matched to adalimumab (1 SC injection) at Week 1 and every other week thereafter through Week 15 during PCP.
59936|NCT02207244|P1|Participant Flow|Placebo (Week 0 - 16)|Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Week 1 and every other week thereafter through Week 15 to maintain the blind during placebo controlled period (PCP).
60501|NCT02203916|P1|Participant Flow|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
59937|NCT02207244|O2|Outcome|Adalimumab|Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and every other Week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12.
59938|NCT02207244|O1|Outcome|Guselkumab 100 mg|Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and1 2, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
59939|NCT02207244|O2|Outcome|Guselkumab 100 mg|Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
59940|NCT02207244|O1|Outcome|Placebo|Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.
59941|NCT02207244|O2|Outcome|Guselkumab 100 mg|Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5, and q2w thereafter through Week 15.
59942|NCT02207244|O1|Outcome|Placebo|Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.
59943|NCT02207244|O2|Outcome|Adalimumab|Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and every other Week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12.
59944|NCT02207244|O1|Outcome|Guselkumab 100 mg|Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
59945|NCT02207244|O2|Outcome|Adalimumab|Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and every other Week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12.
59946|NCT02207244|O1|Outcome|Guselkumab 100 mg|Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
59947|NCT02207244|O2|Outcome|Adalimumab|Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and every other week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12.
59948|NCT02207244|O1|Outcome|Guselkumab 100 mg|Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5, and q2w thereafter through Week 15.
59949|NCT02207244|O2|Outcome|Guselkumab 100 mg|Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
59950|NCT02207244|O1|Outcome|Placebo|Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.
59951|NCT02207244|O2|Outcome|Guselkumab Maintenance Group|Participants of maintenance group received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5, 7, and q2w through Week 15. Participants received placebo matched to guselkumab SC injection at Week 16 then guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at q2w from Week 17 through Week 23. These participants were PASI 90 responders who were randomized to receive guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 44 and placebo matched to guselkumab SC injection at Weeks 32, 40 and 48.
59952|NCT02207244|O1|Outcome|Withdrawal Group|Participants in withdrawal group received guselkumab 100 mg SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w through Week 15 to maintain the blind during PCP. Participants received placebo matched to guselkumab SC injection at Week 16 then guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at q2w from Week 17 through Week 23. These participants who were PASI 90 responders at Week 28 were randomized to receive placebo matched to guselkumab SC injection at Week 28 and q4w thereafter through Week 48 until loss of >=50% in the improvement in PASI.
59953|NCT02207244|O2|Outcome|Adalimumab|Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and every other week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12. Participants who received adalimumab in the first period, continued to receive adalimumab 40 mg (1 SC injection) q2w from Week 17 through Week 23 and placebo matched to guselkumab SC injection at Weeks 16 and 20.
59954|NCT02207244|O1|Outcome|Guselkumab 100 mg|Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15. Participants received placebo matched to guselkumab SC injection at Week 16 then guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21 and 23.
59955|NCT02207244|O2|Outcome|Adalimumab|Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and every other week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12. Participants who received adalimumab in the first period, continued to receive adalimumab 40 mg (1 SC injection) q2w from Week 17 through Week 23 and placebo matched to guselkumab SC injection at Weeks 16 and 20.
60010|NCT02207088|B1|Baseline|3-DAA ± RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) with or ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks
59956|NCT02207244|O1|Outcome|Guselkumab 100 mg|Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15. Participants received placebo matched to guselkumab SC injection at Week 16 then guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21 and 23.
59957|NCT02207244|O2|Outcome|Adalimumab|Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and every other week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12. Participants who received adalimumab in the first period, continued to receive adalimumab 40 mg (1 SC injection) q2w from Week 17 through Week 23 and placebo matched to guselkumab SC injection at Weeks 16 and 20.
59958|NCT02207244|O1|Outcome|Guselkumab 100 mg|Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15. Participants received placebo matched to guselkumab SC injection at Week 16 then guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21 and 23.
59959|NCT02207244|O2|Outcome|Guselkumab 100 mg|Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
59960|NCT02207244|O1|Outcome|Placebo|Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.
59961|NCT02207244|O2|Outcome|Guselkumab 100 mg|Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
59962|NCT02207244|O1|Outcome|Placebo|Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.
59963|NCT02207244|E10|Reported Event|Adalimumab (Week 28 - 48)|Participants who were assigned to adalimumab through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 responders and were subsequently treated only with placebo matched to guselkumab subcutaneous injection through up to Week 48 (never met the criterion for treatment with guselkumab). The group also includes participants who were assigned to adalimumab, discontinued study agent prior to or at Week 28 and completed safety follow up after Week 28. The presentation of data from the adalimumab group from Week 28 to Week 48 is divided into 2 arms (adalimumab then guselkumab 100 mg (Week 28 - 48) and adalimumab (Week 28 - 48) in order to represent exposure to 2 different active study agents (adalimumab vs guselkumab).
59964|NCT02207244|E9|Reported Event|Adalimumab Then Guselkumab 100 mg (Week 28 - 48)|Participants who were assigned to the adalimumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders received guselkumab 100 mg SC injection at Week 28 and 32 and q8w thereafter through Week 48 and placebo matched to guselkumab SC injection at Weeks 36 and 44. Participants who were PASI 90 responders, received placebo matched to guselkumab subcutaneous injection q4w thereafter through Week 48 or until loss of >=50% in the improvement in PASI. If they lost response according to this definition, they were treated with guselkumab. The presentation of data from the adalimumab group from Week 28 to Week 48 is divided into 2 arms (adalimumab then guselkumab 100 mg (Week 28 - 48) and adalimumab (Week 28 - 48) in order to represent exposure to 2 different active study agents (adalimumab vs guselkumab).
59965|NCT02207244|E8|Reported Event|Guselkumab 100 mg (Week 28 - 48)|Participants assigned to the guselkumab arm through Week28 were assessed for PASI90 response at Week28. PASI90 non-responders at Week28 received guselkumab 100 mg SC injection at Week28 and q8w thereafter through Week44 and placebo matched to guselkumab at Weeks32, 40 and 48. PASI90 responders were rerandomized to either guselkumab or placebo. Participants rerandomized to guselkumab, took guselkumab 100 mg SC at Week28 and q8w thereafter through Week44 and placebo matched to guselkumab SC at Weeks32, 40 and 48. Participants rerandomized to placebo, received placebo matched to guselkumab SC injection q4w through Week48 or until loss of >=50% improvement in PASI. If they lost response as per this definition, were retreated with guselkumab. Safety data for this arm was not planned to split into sub-groups as comparisons may be made inappropriately between these groups, when any observed differences may be due to inherent differences in these populations defined based on response status.
59966|NCT02207244|E7|Reported Event|Placebo Then Guselkumab 100 mg (Week 28 - 48)|Participants assigned to the placebo, then guselkumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders received guselkumab 100 mg SC injection at Week 28 and then every 8 weeks (q8w) thereafter through Week 44 and placebo matched to guselkumab SC injection at Weeks 32, 40 and 48. Participants who were PASI 90 responders at Week 28 received placebo matched to guselkumab SC injection at Week 28 and every 4 weeks (q4w) thereafter through Week 48 or until loss of greater than or equal to (>=) 50 percentage (%) in the improvement in PASI. If they lost response according to this definition, they were retreated with guselkumab. Safety data for this arm was not planned to split into sub-groups as comparisons may be made inappropriately between these groups, when any observed differences may be due to inherent differences in these populations defined based on response status.
59967|NCT02207244|E6|Reported Event|Adalimumab (Week 16 - 28)|Participants who received adalimumab in the first period, continued to receive adalimumab 40 mg (1 SC injection) every 2 weeks (q2w) from Week 17 through Week 23 and placebo matched to guselkumab SC injection at Weeks 16 and 20.
59968|NCT02207244|E5|Reported Event|Guselkumab 100 mg (Week 16 - 28)|Participants who started receiving guselkumab in the first period, received placebo matched to guselkumab SC injection at Week 16 followed by guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21 and 23.
59969|NCT02207244|E4|Reported Event|Placebo Then Guselkumab 100 mg (Week 16 - 28)|Participants who started receiving placebo in the first period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21, and 23 during the active comparator controlled period (ACP).
61392|NCT02201056|O3|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
59970|NCT02207244|E3|Reported Event|Adalimumab (Week 0 - 16)|Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Week 1 and every other week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12 during PCP.
59971|NCT02207244|E2|Reported Event|Guselkumab 100 mg (Week 0 - 16)|Participants received guselkumab 100 milligram (mg) SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 followed by placebo matched to adalimumab (1 SC injection) at Week 1 and every other week thereafter through Week 15 during PCP.
59972|NCT02207244|E1|Reported Event|Placebo (Week 0 - 16)|Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Week 1 and every other week thereafter through Week 15 to maintain the blind during placebo controlled period (PCP).
59973|NCT02207231|B4|Baseline|Total|Total of all reporting groups
59974|NCT02207231|B3|Baseline|Adalimumab|Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.
59975|NCT02207231|B2|Baseline|Guselkumab 100 mg|Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47.
59976|NCT02207231|B1|Baseline|Placebo Then Guselkumab 100 mg|Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks through Week 15 in the placebo controlled period (PCP). Participants then crossed over to receive guselkumab 100 milligram (mg) subcutaneous injection at Weeks 16 and 20 and once every 8 weeks thereafter through Week 44 and placebo matched to adalimumab subcutaneous injection at Weeks 17, 19, 21, and 23 and every 2 weeks thereafter through Week 47 in the active controlled period (ACP).
59977|NCT02207231|P3|Participant Flow|Adalimumab|Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.
59978|NCT02207231|P2|Participant Flow|Guselkumab 100 mg|Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47.
59979|NCT02207231|P1|Participant Flow|Placebo Then Guselkumab 100 mg|Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP). Participants then crossed over to receive guselkumab 100 milligram (mg) subcutaneous injection at Weeks 16 and 20 and once every 8 weeks thereafter through Week 44 and placebo matched to adalimumab subcutaneous injection at Weeks 17, 19, 21, and 23 and every 2 weeks thereafter through Week 47 in the active controlled period (ACP).
59980|NCT02207231|O2|Outcome|Adalimumab|Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.
59981|NCT02207231|O1|Outcome|Guselkumab|Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47.
59982|NCT02207231|O2|Outcome|Guselkumab|Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
59983|NCT02207231|O1|Outcome|Placebo|Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).
59984|NCT02207231|O2|Outcome|Guselkumab|Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
59985|NCT02207231|O1|Outcome|Placebo|Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).
59986|NCT02207231|O2|Outcome|Adalimumab|Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 15 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12.
59987|NCT02207231|O1|Outcome|Guselkumab|Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
59988|NCT02207231|O2|Outcome|Adalimumab|Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 15 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12.
59989|NCT02207231|O1|Outcome|Guselkumab|Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
59990|NCT02207231|O2|Outcome|Adalimumab|Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 15 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12.
59991|NCT02207231|O1|Outcome|Guselkumab|Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
59992|NCT02207231|O2|Outcome|Guselkumab|Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
59993|NCT02207231|O1|Outcome|Placebo|Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).
59994|NCT02207231|O2|Outcome|Adalimumab|Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.
59995|NCT02207231|O1|Outcome|Guselkumab|Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47.
59996|NCT02207231|O2|Outcome|Adalimumab|Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.
59997|NCT02207231|O1|Outcome|Guselkumab|Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47.
59998|NCT02207231|O2|Outcome|Adalimumab|Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.
59999|NCT02207231|O1|Outcome|Guselkumab|Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47.
60000|NCT02207231|O2|Outcome|Guselkumab|Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
60001|NCT02207231|O1|Outcome|Placebo|Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).
60002|NCT02207231|O2|Outcome|Guselkumab|Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
60003|NCT02207231|O1|Outcome|Placebo|Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).
60004|NCT02207231|E6|Reported Event|Adalimumab (ACP)|Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.
60005|NCT02207231|E5|Reported Event|Guselkumab 100 mg (ACP)|Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47.
60006|NCT02207231|E4|Reported Event|Placebo Then Guselkumab 100 mg (ACP)|Participants initially randomized to placebo crossed over to receive guselkumab 100 milligram (mg) subcutaneous injection at Weeks 16 and 20 and once every 8 weeks thereafter through Week 44 in the active controlled period (ACP).
60007|NCT02207231|E3|Reported Event|Adalimumab (PCP)|Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Week 1 and once every other week thereafter through Week 15 during the placebo controlled period.
60008|NCT02207231|E2|Reported Event|Guselkumab 100 mg (PCP)|Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 during the placebo controlled period.
60009|NCT02207231|E1|Reported Event|Placebo (PCP)|Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12 during the placebo controlled period.
60011|NCT02207088|P1|Participant Flow|3-DAA ± RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) with or without ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks
60012|NCT02207088|O1|Outcome|3-DAA ± RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) with or without ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks
60013|NCT02207088|O1|Outcome|3-DAA ± RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) with or without ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks
60014|NCT02207088|O1|Outcome|3-DAA ± RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) with or without ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks
60015|NCT02207088|E1|Reported Event|3-DAA +/- RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) with or without ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks
60016|NCT02206776|B3|Baseline|Total|Total of all reporting groups
60017|NCT02206776|B2|Baseline|Ketamine|"A single dose of intranasal ketamine up to 50 mg~Intranasal Ketamine: A single dose of intranasal ketamine up to 50 mg"
60018|NCT02206776|B1|Baseline|Midazolam|"A single dose of intranasal midazolam up to 4 mg~Intranasal Midazolam: A single dose of intranasal Midazolam up to 4 mg"
60019|NCT02206776|P2|Participant Flow|Ketamine|"A single dose of intranasal ketamine up to 50 mg~Intranasal Ketamine: A single dose of intranasal ketamine up to 50 mg"
60020|NCT02206776|P1|Participant Flow|Midazolam|"A single dose of intranasal midazolam up to 4 mg~Intranasal Midazolam: A single dose of intranasal Midazolam up to 4 mg"
60021|NCT02206776|O2|Outcome|Ketamine|"A single dose of intranasal ketamine up to 50 mg~Intranasal Ketamine: A single dose of intranasal ketamine up to 50 mg"
60022|NCT02206776|O1|Outcome|Midazolam|"A single dose of intranasal midazolam up to 4 mg~Intranasal Midazolam: A single dose of intranasal Midazolam up to 4 mg"
60023|NCT02206776|E2|Reported Event|Ketamine|"A single dose of intranasal ketamine up to 50 mg~Intranasal Ketamine: A single dose of intranasal ketamine up to 50 mg"
60024|NCT02206776|E1|Reported Event|Midazolam|"A single dose of intranasal midazolam up to 4 mg~Intranasal Midazolam: A single dose of intranasal Midazolam up to 4 mg"
60025|NCT02206607|B1|Baseline|All Participants|Participants received at least 1 dose of PF-04937319.
60026|NCT02206607|P5|Participant Flow|Sequence DCAB: PF-04937319 330 mg MR3 First|Participants received PF-04937319 330 mg MR3, followed by PF-04937319 300 mg MR2, followed by PF-04937319 150+100 mg IR, followed by PF-04937319 250 mg MR1. There was a 5 to 10-day washout between dosing across the 4 regimens.
60027|NCT02206607|P4|Participant Flow|Sequence CBDA: PF-04937319 300 mg MR2 First|Participants received PF-04937319 300 mg MR2, followed by PF-04937319 250 mg MR1, followed by PF-04937319 330 mg MR3, followed by PF-04937319 150+100 mg IR. There was a 5 to 10-day washout between dosing across the 4 regimens.
60028|NCT02206607|P3|Participant Flow|Sequence BACD: PF-04937319 250 mg MR1 First|Participants received PF-04937319 MR1 250 mg, followed by PF-04937319 150+100 mg IR, followed by PF-04937319 300 mg MR2, followed by PF-04937319 330 mg MR3. There was a 5 to 10-day washout between dosing across the 4 regimens.
60029|NCT02206607|P2|Participant Flow|Sequence ADBC: PF-04937319 150+100 mg IR First|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch, followed by PF-04937319 modified-release formulation #3 (MR3) 330 mg, followed by PF-04937319 modified-release formulation #1 (MR1) 250 mg, followed by PF-04937319 modified-release formulation #2 (MR2) 300 mg. There was a 5 to 10-day washout between dosing across the 4 regimens.
60030|NCT02206607|P1|Participant Flow|Metformin Run-In|Participants received open-label, sponsor-provided metformin tablet(s) orally at a dose in multiples of 500 mg (minimum dose 500 mg, maximum dose 2500 mg). Participants who met eligibility criteria on metformin were then randomized to 1 of 4 treatment sequences.
60031|NCT02206607|O5|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60032|NCT02206607|O4|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60033|NCT02206607|O3|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60034|NCT02206607|O2|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
60035|NCT02206607|O1|Outcome|Metformin Run-In|Participants received open-label, sponsor-provided metformin tablet(s) orally at a dose in multiples of 500 mg (minimum dose 500 mg, maximum dose 2500 mg). Participants who met eligibility criteria on metformin were then randomized to 1 of 4 treatment regimens.
60036|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60037|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60038|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60039|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
60040|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60041|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60042|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60043|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
60044|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60045|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60046|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60047|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
60048|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60049|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60050|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60051|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
60052|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60053|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60054|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60055|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
60056|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60057|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60058|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60059|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
60060|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60061|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60062|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60063|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
60064|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60065|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60066|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60067|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
60068|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60069|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60070|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60107|NCT02205814|E3|Reported Event|Fasitibant High Dose|"Drug: solution for intra-articular injection~Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
60071|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
60072|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60073|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60074|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60075|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
60076|NCT02206607|E5|Reported Event|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60077|NCT02206607|E4|Reported Event|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60078|NCT02206607|E3|Reported Event|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
60079|NCT02206607|E2|Reported Event|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
60080|NCT02206607|E1|Reported Event|Metformin Run-In|Participants received open-label, sponsor-provided metformin tablet(s) orally at a dose in multiples of 500 mg (minimum dose 500 mg, maximum dose 2500 mg). Participants who met eligibility criteria on metformin were then randomized to 1 of 4 treatment regimens.
60081|NCT02205814|B5|Baseline|Total|Total of all reporting groups
60082|NCT02205814|B4|Baseline|PLACEBO|"Drug: solution for intra-articular injection~Placebo comparator: Single intra-articular injection of placebo"
60083|NCT02205814|B3|Baseline|Fasitibant High Dose|"Drug: solution for intra-articular injection~Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
60084|NCT02205814|B2|Baseline|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection~Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
60085|NCT02205814|B1|Baseline|Fasitibant Low Dose|"Drug: solution for intra-articular injection~Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
60086|NCT02205814|P4|Participant Flow|PLACEBO|"Drug: solution for intra-articular injection~Placebo comparator: Single intra-articular injection of placebo"
60087|NCT02205814|P3|Participant Flow|Fasitibant High Dose|"Drug: solution for intra-articular injection~Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
60088|NCT02205814|P2|Participant Flow|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection~Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
60089|NCT02205814|P1|Participant Flow|Fasitibant Low Dose|"Drug: solution for intra-articular injection~Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
60090|NCT02205814|O4|Outcome|PLACEBO|"Drug: solution for intra-articular injection~Placebo comparator: Single intra-articular injection of placebo"
60091|NCT02205814|O3|Outcome|Fasitibant High Dose|"Drug: solution for intra-articular injection~Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
60092|NCT02205814|O2|Outcome|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection~Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
60093|NCT02205814|O1|Outcome|Fasitibant Low Dose|"Drug: solution for intra-articular injection~Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
60094|NCT02205814|O4|Outcome|PLACEBO|"Drug: solution for intra-articular injection~Placebo comparator: Single intra-articular injection of placebo"
60095|NCT02205814|O3|Outcome|Fasitibant High Dose|"Drug: solution for intra-articular injection~Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
60096|NCT02205814|O2|Outcome|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection~Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
60097|NCT02205814|O1|Outcome|Fasitibant Low Dose|"Drug: solution for intra-articular injection~Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
60098|NCT02205814|O4|Outcome|PLACEBO|"Drug: solution for intra-articular injection~Placebo comparator: Single intra-articular injection of placebo"
60099|NCT02205814|O3|Outcome|Fasitibant High Dose|"Drug: solution for intra-articular injection~Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
60100|NCT02205814|O2|Outcome|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection~Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
60101|NCT02205814|O1|Outcome|Fasitibant Low Dose|"Drug: solution for intra-articular injection~Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
60102|NCT02205814|O4|Outcome|PLACEBO|"Drug: solution for intra-articular injection~Placebo comparator: Single intra-articular injection of placebo"
60103|NCT02205814|O3|Outcome|Fasitibant High Dose|"Drug: solution for intra-articular injection~Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
60104|NCT02205814|O2|Outcome|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection~Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
60105|NCT02205814|O1|Outcome|Fasitibant Low Dose|"Drug: solution for intra-articular injection~Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
60106|NCT02205814|E4|Reported Event|PLACEBO|"Drug: solution for intra-articular injection~Placebo comparator: Single intra-articular injection of placebo"
60108|NCT02205814|E2|Reported Event|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection~Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
60109|NCT02205814|E1|Reported Event|Fasitibant Low Dose|"Drug: solution for intra-articular injection~Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
60110|NCT02205801|B5|Baseline|Total|Total of all reporting groups
60111|NCT02205801|B4|Baseline|Local Wound Infiltration, Placebo|"After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.~Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~0.9% saline"
60112|NCT02205801|B3|Baseline|Local Wound Infiltration, Active|"After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.~Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~Marcaine"
60113|NCT02205801|B2|Baseline|Superficial Cervical Block, Placebo|"After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.~Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~0.9% saline"
60114|NCT02205801|B1|Baseline|Superficial Cervical Block, Active|"After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.~Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~Marcaine"
60115|NCT02205801|P4|Participant Flow|Local Wound Infiltration, Placebo|"After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.~Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~0.9% saline"
60116|NCT02205801|P3|Participant Flow|Local Wound Infiltration, Active|"After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.~Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~Marcaine"
60117|NCT02205801|P2|Participant Flow|Superficial Cervical Block, Placebo|"After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.~Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~0.9% saline"
60118|NCT02205801|P1|Participant Flow|Superficial Cervical Block, Active|"After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.~Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~Marcaine"
60119|NCT02205801|O4|Outcome|Local Wound Infiltration, Placebo|"After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.~Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~0.9% saline"
60120|NCT02205801|O3|Outcome|Local Wound Infiltration, Active|"After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.~Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~Marcaine"
60121|NCT02205801|O2|Outcome|Superficial Cervical Block, Placebo|"After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.~Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~0.9% saline"
60122|NCT02205801|O1|Outcome|Superficial Cervical Block, Active|"After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.~Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~Marcaine"
60123|NCT02205801|O4|Outcome|Local Wound Infiltration, Placebo|"After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.~Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~0.9% saline"
60124|NCT02205801|O3|Outcome|Local Wound Infiltration, Active|"After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.~Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~Marcaine"
60125|NCT02205801|O2|Outcome|Superficial Cervical Block, Placebo|"After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.~Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~0.9% saline"
60126|NCT02205801|O1|Outcome|Superficial Cervical Block, Active|"After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.~Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~Marcaine"
60127|NCT02205801|O4|Outcome|Local Wound Infiltration, Placebo|"After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.~Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~0.9% saline"
60325|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
60128|NCT02205801|O3|Outcome|Local Wound Infiltration, Active|"After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.~Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~Marcaine"
60129|NCT02205801|O2|Outcome|Superficial Cervical Block, Placebo|"After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.~Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~0.9% saline"
60130|NCT02205801|O1|Outcome|Superficial Cervical Block, Active|"After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.~Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~Marcaine"
60131|NCT02205801|O4|Outcome|Local Wound Infiltration, Placebo|"After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.~Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~0.9% saline"
60132|NCT02205801|O3|Outcome|Local Wound Infiltration, Active|"After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.~Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~Marcaine"
60133|NCT02205801|O2|Outcome|Superficial Cervical Block, Placebo|"After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.~Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~0.9% saline"
60134|NCT02205801|O1|Outcome|Superficial Cervical Block, Active|"After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.~Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~Marcaine"
60135|NCT02205801|E4|Reported Event|Local Wound Infiltration, Placebo|"After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.~Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~0.9% saline"
60136|NCT02205801|E3|Reported Event|Local Wound Infiltration, Active|"After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.~Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~Marcaine"
60137|NCT02205801|E2|Reported Event|Superficial Cervical Block, Placebo|"After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.~Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~0.9% saline"
60138|NCT02205801|E1|Reported Event|Superficial Cervical Block, Active|"After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.~Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~Marcaine"
60139|NCT02205476|B3|Baseline|Total|Total of all reporting groups
60140|NCT02205476|B2|Baseline|Group 2: PF­-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
60141|NCT02205476|B1|Baseline|Group 1: PF­-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
60142|NCT02205476|P2|Participant Flow|Group 2: PF­-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
60143|NCT02205476|P1|Participant Flow|Group 1: PF­-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
60144|NCT02205476|O4|Outcome|Group 2: Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
60145|NCT02205476|O3|Outcome|Group 2: PF¬06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
60502|NCT02203916|O3|Outcome|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
60146|NCT02205476|O2|Outcome|Group 1: Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
60147|NCT02205476|O1|Outcome|Group 1: PF­-06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
60148|NCT02205476|O2|Outcome|Group 2: PF­-06473871/Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
60149|NCT02205476|O1|Outcome|Group 1: PF­-06473871/Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
60150|NCT02205476|O2|Outcome|Group 2: PF­-06473871/Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
60151|NCT02205476|O1|Outcome|Group 1: PF­-06473871/Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
60152|NCT02205476|O2|Outcome|Group 2: PF­-06473871/Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
60153|NCT02205476|O1|Outcome|Group 1: PF­-06473871/Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
60154|NCT02205476|O4|Outcome|Group 2: Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
60155|NCT02205476|O3|Outcome|Group 2: PF¬06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
60156|NCT02205476|O2|Outcome|Group 1: Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
60157|NCT02205476|O1|Outcome|Group 1: PF­06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
60158|NCT02205476|O4|Outcome|Group 2: Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
60159|NCT02205476|O3|Outcome|Group 2: PF¬06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
60160|NCT02205476|O2|Outcome|Group 1: Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
60161|NCT02205476|O1|Outcome|Group 1: PF­06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
60503|NCT02203916|O2|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
60162|NCT02205476|O4|Outcome|Group 2: Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
60163|NCT02205476|O3|Outcome|Group 2: PF-06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
60164|NCT02205476|O2|Outcome|Group 1: Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
60165|NCT02205476|O1|Outcome|Group 1: PF­06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
60166|NCT02205476|O4|Outcome|Group 2: Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
60167|NCT02205476|O3|Outcome|Group 2: PF¬06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
60168|NCT02205476|O2|Outcome|Group 1: Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
60169|NCT02205476|O1|Outcome|Group 1: PF­-06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
60170|NCT02205476|E2|Reported Event|Group 2: PF­-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
60171|NCT02205476|E1|Reported Event|Group 1: PF­-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
60172|NCT02205333|B10|Baseline|Total|Total of all reporting groups
60173|NCT02205333|B9|Baseline|MEDI6469 10 mg/kg+Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60174|NCT02205333|B8|Baseline|MEDI6469 2 mg/kg+Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60175|NCT02205333|B7|Baseline|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60176|NCT02205333|B6|Baseline|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60177|NCT02205333|B5|Baseline|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
60178|NCT02205333|B4|Baseline|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
60179|NCT02205333|B3|Baseline|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
60180|NCT02205333|B2|Baseline|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
60181|NCT02205333|B1|Baseline|MEDI6469 6 Milligram/Kilogram (mg/kg)|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
60182|NCT02205333|P9|Participant Flow|MEDI6469 10 mg/kg+Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60183|NCT02205333|P8|Participant Flow|MEDI6469 2 mg/kg+Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60504|NCT02203916|O1|Outcome|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
60184|NCT02205333|P7|Participant Flow|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60185|NCT02205333|P6|Participant Flow|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60186|NCT02205333|P5|Participant Flow|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
60187|NCT02205333|P4|Participant Flow|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
60188|NCT02205333|P3|Participant Flow|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
60189|NCT02205333|P2|Participant Flow|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
60190|NCT02205333|P1|Participant Flow|MEDI6469 6 Milligram/Kilogram (mg/kg)|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
60191|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60192|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60193|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60194|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60195|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
60196|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
60197|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
60198|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
60199|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
60200|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60201|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60202|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60203|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60204|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
60205|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
60206|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
60207|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
60208|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
60209|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60210|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60211|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
61393|NCT02201056|O2|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
60212|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60213|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
60214|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
60215|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
60216|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
60217|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
60218|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60219|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60220|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60221|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60222|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
60223|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
60224|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
60225|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
60226|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
60227|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60228|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60229|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60230|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60231|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
60232|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
60233|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
60234|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
60235|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
60236|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60237|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60238|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60239|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60505|NCT02203916|O3|Outcome|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
60240|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
60241|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
60242|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
60243|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
60244|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
60245|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60246|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60247|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60248|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60249|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
60250|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
60251|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
60252|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
60253|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
60254|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60255|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60256|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60257|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60258|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
60259|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
60260|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
60261|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
60262|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
60263|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60264|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60265|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60266|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60267|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
60506|NCT02203916|O2|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
60268|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
60269|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
60270|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
60271|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
60272|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60273|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60274|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60275|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60276|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
60277|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
60278|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
60279|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
60280|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
60281|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60282|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60283|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60284|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60285|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
60286|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
60287|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
60288|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
60289|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
60290|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60291|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60292|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60293|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60294|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
60295|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
60507|NCT02203916|O1|Outcome|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
60296|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
60297|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
60298|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
60299|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60300|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60301|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60302|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60303|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
60304|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
60305|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
60306|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
60307|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
60308|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60309|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60310|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60311|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60312|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
60313|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
60314|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
60315|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
60316|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
60317|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60318|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60319|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60320|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60321|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
60322|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
60323|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
60324|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
60326|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60327|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60328|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60329|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60330|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
60331|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
60332|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
60333|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
60334|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
60335|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60336|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60337|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60338|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60339|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
60340|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
60341|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
60342|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
60343|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
60344|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60345|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60346|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60347|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60348|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
60349|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
60350|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
60351|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
60352|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
60353|NCT02205333|E9|Reported Event|MEDI6469 10 mg/kg+Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
104922|NCT01955564|E6|Reported Event|Cohort 5|NW-3509a 20 mg, single dose
60354|NCT02205333|E8|Reported Event|MEDI6469 2 mg/kg+Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
60355|NCT02205333|E7|Reported Event|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60356|NCT02205333|E6|Reported Event|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
60357|NCT02205333|E5|Reported Event|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
60358|NCT02205333|E4|Reported Event|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
60359|NCT02205333|E3|Reported Event|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
60360|NCT02205333|E2|Reported Event|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
60361|NCT02205333|E1|Reported Event|MEDI6469 6 Milligram/Kilogram (mg/kg)|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
60362|NCT02204748|B1|Baseline|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
60363|NCT02204748|P1|Participant Flow|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
60364|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
60365|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
60366|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
60367|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
60368|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
60369|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
60370|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
60371|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
60372|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
60373|NCT02204748|E1|Reported Event|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
60374|NCT02204657|B3|Baseline|Total|Total of all reporting groups
60375|NCT02204657|B2|Baseline|Control|Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
60376|NCT02204657|B1|Baseline|Continuous Glucose Monitoring System|"Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.~Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings"
60377|NCT02204657|P2|Participant Flow|Control|Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
60378|NCT02204657|P1|Participant Flow|Continuous Glucose Monitoring System|"Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.~Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings"
60379|NCT02204657|O2|Outcome|Control|Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
60472|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
60380|NCT02204657|O1|Outcome|Continuous Glucose Monitoring System|"Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.~Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings"
60381|NCT02204657|O2|Outcome|Control|Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
60382|NCT02204657|O1|Outcome|Continuous Glucose Monitoring System|"Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.~Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings"
60383|NCT02204657|E2|Reported Event|Control|Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
60384|NCT02204657|E1|Reported Event|Continuous Glucose Monitoring System|"Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.~Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings"
60385|NCT02204579|B1|Baseline|NPSP795|
60386|NCT02204579|P1|Participant Flow|NPSP795|
60387|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
60388|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
60389|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
60390|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
60391|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
60392|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
60393|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
60394|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
60395|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
60396|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
60397|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
60398|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
60399|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
60400|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
60401|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
60402|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
60403|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
60404|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
60405|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
60406|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
60407|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
60408|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
60409|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
60410|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
60411|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
60412|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
60413|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
60414|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
60415|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
60416|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
60417|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
60418|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
60419|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
60420|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
60421|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
60422|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
60423|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
60424|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
60425|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
60426|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
60427|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
60428|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
60429|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
60430|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
60431|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
60432|NCT02204579|O1|Outcome|NPSP795|
60433|NCT02204579|O1|Outcome|NPSP795|
60434|NCT02204579|O1|Outcome|NPSP795|
60435|NCT02204579|O1|Outcome|NPSP795|
60436|NCT02204579|E1|Reported Event|NPSP795|
60437|NCT02204449|B3|Baseline|Total|Total of all reporting groups
60438|NCT02204449|B2|Baseline|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
60473|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
60474|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
60475|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
60439|NCT02204449|B1|Baseline|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.~One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.~Cardiac Rehabilitation Peer Mentorship"
60440|NCT02204449|P2|Participant Flow|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
60441|NCT02204449|P1|Participant Flow|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.~One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.~Cardiac Rehabilitation Peer Mentorship"
60442|NCT02204449|O2|Outcome|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
60443|NCT02204449|O1|Outcome|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.~One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.~Cardiac Rehabilitation Peer Mentorship"
60444|NCT02204449|O2|Outcome|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
60445|NCT02204449|O1|Outcome|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.~One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.~Cardiac Rehabilitation Peer Mentorship"
60446|NCT02204449|O2|Outcome|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
60447|NCT02204449|O1|Outcome|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.~One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.~Cardiac Rehabilitation Peer Mentorship"
60448|NCT02204449|E2|Reported Event|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
60476|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
60477|NCT02204371|E1|Reported Event|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
60449|NCT02204449|E1|Reported Event|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.~One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.~Cardiac Rehabilitation Peer Mentorship"
60450|NCT02204410|B1|Baseline|Omega-3 Fatty Acids and Stimulant Treatment|Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment.
60451|NCT02204410|P1|Participant Flow|Omega-3 Fatty Acids and Stimulant Treatment|Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment.
60452|NCT02204410|O1|Outcome|Omega-3 Fatty Acids and Stimulant Treatment|Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment.
60453|NCT02204410|O1|Outcome|Omega-3 Fatty Acids and Stimulant Treatment|Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment.
60454|NCT02204410|E1|Reported Event|Omega-3 Fatty Acids and Stimulant Treatment|Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment.
60455|NCT02204371|B1|Baseline|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
60456|NCT02204371|P1|Participant Flow|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
60457|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
60458|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
60459|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
60460|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
60461|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
60462|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
60463|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
60464|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
60465|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
60466|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
60467|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
60468|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
60469|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
60470|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
60471|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
60478|NCT02204319|B1|Baseline|Cold Laser Recipients|"10 enrolled in the study. Seven completed the study and three withdrew. Each participant received six cold laser light therapy treatments and were assessed pre and post treatment with Q tip testing at each treatment visit. There was also a two week follow up scheduled for re-assessment.~Treatment for each patient was not standardized since there were four therapists involved in data collection and treatment. The treatments included manual therapy mobilizations, neuromuscular rehabilitation with or without EMG biofeedback, home care training which may have included lubricant usage, dilator training, and exercises for the pelvic floor as well as methods of pain relieving modalities."
60479|NCT02204319|P1|Participant Flow|Cold Laser Treatment|"Cold laser used off of the body over the vulvar involved area. The device to be used in this study is the Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device. Weekly visits x 6 with 5 minute treatments over vulva and sacral nerve roots each.~Cold laser: Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device."
60480|NCT02204319|O1|Outcome|Cold Laser Recipients|"10 enrolled in the study. Seven completed the study and three withdrew. Each participant received six cold laser light therapy treatments and were assessed pre and post treatment with Q tip testing. There was a two week follow up scheduled for assessment.~Treatment for each patient was not standardized since there were four therapists involved in data collection and treatment. The treatments included manual therapy mobilizations, neuromuscular rehabilitation with or without EMG biofeedback, home care training which may have included lubricant usage, dilator training, and exercises for the pelvic floor as well as methods of pain relieving modalities."
60481|NCT02204319|O1|Outcome|Cold Laser Treatment|"Cold laser used off of the body over the vulvar involved area. The device to be used in this study is the Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device. Weekly visits x 6 with 5 minute treatments over vulva and sacral nerve roots each.~Cold laser: Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device."
60482|NCT02204319|O1|Outcome|Cold Laser Treatment|"Cold laser used off of the body over the vulvar involved area. The device to be used in this study is the Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device. Weekly visits x 6 with 5 minute treatments over vulva and sacral nerve roots each.~Cold laser: Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device."
60483|NCT02204319|E1|Reported Event|Cold Laser Light Therapy|The laser unit emits three independent 7 mW, 635 nm red light diodes in a hand-held device and is a variable frequency pulsed wave device. Erchonia low level lasers have been determined safe and effective and non-significant risk (NSR) by the Food and Drug Administration (FDA) for application for numerous and various pain reduction indications, providing justification for the anticipated safety and effectiveness of application The cold laser was administered over 10 minutes as follows: 5 minutes at the area of sacral nerve roots 2-4 in the side-lying position- hertz settings: 14, 8, 12, 28; and 5 minutes at the vulva in the lithotomy position, hertz settings 2: 9,16,33,60 while the outer labia were held open by the therapist. A sweeping motion was used during administration. The laser head was positioned approximately 3 inches from the skin surface and did not touch the skin. The patient wore safety goggles while the laser treatment was provided.
60484|NCT02204007|B3|Baseline|Total|Total of all reporting groups
60485|NCT02204007|B2|Baseline|Standard of Care Preoperative Imaging|Patients receiving standard of care preoperative planning prior to total hip arthroplasty.
60486|NCT02204007|B1|Baseline|3D Imaging, Surrogate Bone Model|"3D imaging & surrogate bone model~3D imaging & surrogate bone model: 3D imaging & surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging"
60487|NCT02204007|P2|Participant Flow|Standard of Care Preoperative Imaging|Patients receiving standard of care preoperative planning prior to total hip arthroplasty.
60488|NCT02204007|P1|Participant Flow|3D Imaging, Surrogate Bone Model|"3D imaging & surrogate bone model~3D imaging & surrogate bone model: 3D imaging & surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging"
60489|NCT02204007|O2|Outcome|Standard of Care Preoperative Imaging|Patients receiving standard of care preoperative planning prior to total hip arthroplasty.
60490|NCT02204007|O1|Outcome|3D Imaging, Surrogate Bone Model|"3D imaging & surrogate bone model~3D imaging & surrogate bone model: 3D imaging & surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging"
60491|NCT02204007|O2|Outcome|Standard of Care Preoperative Imaging|Patients receiving standard of care preoperative planning prior to total hip arthroplasty.
60492|NCT02204007|O1|Outcome|3D Imaging, Surrogate Bone Model|"3D imaging & surrogate bone model~3D imaging & surrogate bone model: 3D imaging & surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging"
60493|NCT02204007|E2|Reported Event|Standard of Care Preoperative Imaging|Patients receiving standard of care preoperative planning prior to total hip arthroplasty.
60494|NCT02204007|E1|Reported Event|3D Imaging, Surrogate Bone Model|"3D imaging & surrogate bone model~3D imaging & surrogate bone model: 3D imaging & surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging"
60495|NCT02203916|B4|Baseline|Total|Total of all reporting groups
60496|NCT02203916|B3|Baseline|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
60497|NCT02203916|B2|Baseline|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
60498|NCT02203916|B1|Baseline|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
60499|NCT02203916|P3|Participant Flow|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
60500|NCT02203916|P2|Participant Flow|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
60508|NCT02203916|O3|Outcome|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
60509|NCT02203916|O2|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
60510|NCT02203916|O1|Outcome|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
60511|NCT02203916|O3|Outcome|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
60512|NCT02203916|O2|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
60513|NCT02203916|O1|Outcome|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
60514|NCT02203916|O3|Outcome|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
60515|NCT02203916|O2|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
60516|NCT02203916|O1|Outcome|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
60517|NCT02203916|E3|Reported Event|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
60518|NCT02203916|E2|Reported Event|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
60519|NCT02203916|E1|Reported Event|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
60520|NCT02203786|B5|Baseline|Total|Total of all reporting groups
60521|NCT02203786|B4|Baseline|Fluphenazine - Controls|A total of 15 control subjects were enrolled in this arm.
60522|NCT02203786|B3|Baseline|Haloperidol - Controls|A total of 15 control subjects were enrolled in this arm.
60523|NCT02203786|B2|Baseline|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
60524|NCT02203786|B1|Baseline|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
60525|NCT02203786|P4|Participant Flow|Fluphenazine - Controls|"Dose 1: 3 mg fluphenazine (3 capsules @ 1mg each) OR 3 visually identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when participants reach peak blood levels for dose 1. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.~Response measured to 15 min session of a commercial slot machine game. Participants assigned to the fluphenazine antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses).~All participants will receive 2 doses of Dexedrine (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between individual doses."
60526|NCT02203786|P3|Participant Flow|Haloperidol - Controls|"Dose 1: 3 mg haloperidol (3 capsules @ 1 mg each) OR 3 identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when peak blood levels for dose 1 are reached. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, visually identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine. Response measured to 15 min session of a commercial slot machine game.~Haloperidol: Dose/maximum dose 3 mg oral. Participants assigned to the haloperidol antagonist group receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between doses). Dexedrine: Dose/maximum dose 20 mg oral. All participants will receive 2 doses (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between doses."
60527|NCT02203786|P2|Participant Flow|Fluphenazine - Pathological Gamblers|"Dose 1: 3 mg fluphenazine (3 capsules @ 1 mg each) OR 3 visually identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when participants reach peak blood levels for dose 1. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.~Response measured to 15 min session of a commercial slot machine game. Participants assigned to the fluphenazine antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses).~All participants will receive 2 doses of Dexedrine (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between individual doses."
60528|NCT02203786|P1|Participant Flow|Haloperidol - Pathological Gamblers|"Dose 1: 3 mg haloperidol (3 capsules @ 1mg each) OR 3 identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when peak blood levels for dose 1 are reached. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, visually identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine. Response measured to 15 min session of a commercial slot machine game.~Haloperidol: Dose/maximum dose 3 mg oral. Participants assigned to the haloperidol antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between doses).~Dexedrine: Dose/maximum dose 20mg oral. All participants will receive 2 doses (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between doses."
60529|NCT02203786|O4|Outcome|Fluphenazine - Controls|A total of 15 controls were enrolled in this arm.
60530|NCT02203786|O3|Outcome|Haloperidol - Controls|A total of 15 controls were enrolled in this arm.
60531|NCT02203786|O2|Outcome|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
60532|NCT02203786|O1|Outcome|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
60533|NCT02203786|O4|Outcome|Fluphenazine - Controls|A total of 15 control subjects were enrolled in this arm.
60534|NCT02203786|O3|Outcome|Haloperidol - Controls|A total of 15 control subjects were enrolled in this arm.
60535|NCT02203786|O2|Outcome|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
60536|NCT02203786|O1|Outcome|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
60537|NCT02203786|O4|Outcome|Fluphenazine - Controls|A total of 15 controls were enrolled in this arm.
60538|NCT02203786|O3|Outcome|Haloperidol - Controls|A total of 15 controls were enrolled in this arm.
60539|NCT02203786|O2|Outcome|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
60540|NCT02203786|O1|Outcome|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
60543|NCT02203786|O2|Outcome|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
60544|NCT02203786|O1|Outcome|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
60545|NCT02203786|O4|Outcome|Fluphenazine - Controls|A total of 15 controls were enrolled in this arm.
60546|NCT02203786|O3|Outcome|Haloperidol - Controls|A total of 15 controls were enrolled in this arm.
60547|NCT02203786|O2|Outcome|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
60548|NCT02203786|O1|Outcome|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
60549|NCT02203786|O4|Outcome|Fluphenazine - Controls|A total of 15 controls were enrolled in this arm.
60550|NCT02203786|O3|Outcome|Haloperidol - Controls|A total of 15 controls were enrolled in this arm.
60551|NCT02203786|O2|Outcome|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
60552|NCT02203786|O1|Outcome|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
60553|NCT02203786|E4|Reported Event|Fluphenazine - Controls|"Drug sequence 1 (fluphenazine on day 1 of each phase), or drug sequence 2 (fluphenazine on day 2 of each phase).~Dose 1: 3 mg fluphenazine (3 capsules @ 1mg each) OR 3 visually identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when participants reach peak blood levels for dose 1. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.~Response measured to 15 min session of a commercial slot machine game. Participants assigned to the fluphenazine antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses).~All participants will receive 2 doses of Dexedrine (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between individual doses."
60554|NCT02203786|E3|Reported Event|Haloperidol - Controls|"Drug sequence 1 (haloperidol on day 1 of each phase), or drug sequence 2 (haloperidol on day 2 of each phase).~Dose 1: 3mg haloperidol (3 capsules @ 1mg each) OR 3 identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when peak blood levels for dose 1 are reached. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, visually identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.~Response measured to 15 min session of a commercial slot machine game. Haloperidol: Dose/maximum dose 3mg oral. Participants assigned to the haloperidol antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between doses).~Dexedrine: Dose/maximum dose 20mg oral. All participants will receive 2 doses (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between doses."
60555|NCT02203786|E2|Reported Event|Fluphenazine - Pathological Gamblers|"Drug sequence 1 (fluphenazine on day 1 of each phase), or drug sequence 2 (fluphenazine on day 2 of each phase).~Dose 1: 3 mg fluphenazine (3 capsules @ 1mg each) OR 3 visually identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when participants reach peak blood levels for dose 1. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.~Response measured to 15 min session of a commercial slot machine game. Participants assigned to the fluphenazine antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses).~All participants will receive 2 doses of Dexedrine (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between individual doses."
60556|NCT02203786|E1|Reported Event|Haloperidol - Pathological Gamblers|"Drug sequence 1 (haloperidol on day 1 of each phase), or drug sequence 2 (haloperidol on day 2 of each phase).~Dose 1: 3mg haloperidol (3 capsules @ 1mg each) OR 3 identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when peak blood levels for dose 1 are reached. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, visually identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.~Response measured to 15 min session of a commercial slot machine game. Haloperidol: Dose/maximum dose 3mg oral. Participants assigned to the haloperidol antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between doses).~Dexedrine: Dose/maximum dose 20mg oral. All participants will receive 2 doses (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between doses."
60557|NCT02203747|B3|Baseline|Total|Total of all reporting groups
60558|NCT02203747|B2|Baseline|Pseudophakic Implanted With Non-toric IOL|"Subjects implanted with bilateral non-toric IOL~Administration of patient self-assessment"
60559|NCT02203747|B1|Baseline|Pseudophakic Implanted With Toric IOL|"Subjects implanted with bilateral toric IOL~Administration of patient self-assessment"
60560|NCT02203747|P2|Participant Flow|Pseudophakic Implanted With Non-toric IOL|"Subjects implanted with bilateral non-toric IOL~Administration of patient self-assessment"
60561|NCT02203747|P1|Participant Flow|Pseudophakic Implanted With Toric IOL|"Subjects implanted with bilateral toric IOL~Administration of patient self-assessment"
60562|NCT02203747|O2|Outcome|Pseudophakic Implanted With Non-toric IOL|"Subjects implanted with non-toric IOL~Administration of patient self-assessment"
60563|NCT02203747|O1|Outcome|Pseudophakic Implanted With Toric IOL|"Subjects implanted with toric IOL~Administration of patient self-assessment"
60564|NCT02203747|O2|Outcome|Pseudophakic Implanted With Non-toric IOL|"Subjects implanted with non-toric IOL~Administration of patient self-assessment"
60565|NCT02203747|O1|Outcome|Pseudophakic Implanted With Toric IOL|"Subjects implanted with toric IOL~Administration of patient self-assessment"
60566|NCT02203747|E2|Reported Event|Pseudophakic Implanted With Non-toric IOL|"Subjects implanted with non-toric IOL~Administration of patient self-assessment"
60567|NCT02203747|E1|Reported Event|Pseudophakic Implanted With Toric IOL|"Subjects implanted with toric IOL~Administration of patient self-assessment"
60568|NCT02203721|B3|Baseline|Total|Total of all reporting groups
60569|NCT02203721|B2|Baseline|TECNIS Intraocular Lens, Model ZCB00|Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
60570|NCT02203721|B1|Baseline|TECNIS Intraocular Lens, Model ZXR00|Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
60571|NCT02203721|P2|Participant Flow|TECNIS Intraocular Lens, Model ZCB00|Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
60572|NCT02203721|P1|Participant Flow|TECNIS Intraocular Lens, Model ZXR00|Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
60573|NCT02203721|O2|Outcome|TECNIS Intraocular Lens, Model ZCB00|Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
60574|NCT02203721|O1|Outcome|TECNIS Intraocular Lens, Model ZXR00|Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
60575|NCT02203721|O2|Outcome|TECNIS Intraocular Lens, Model ZCB00|Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
60576|NCT02203721|O1|Outcome|TECNIS Intraocular Lens, Model ZXR00|Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
60577|NCT02203721|E2|Reported Event|TECNIS Intraocular Lens, Model ZCB00|Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
60578|NCT02203721|E1|Reported Event|TECNIS Intraocular Lens, Model ZXR00|Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
60579|NCT02203578|B1|Baseline|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
60580|NCT02203578|P1|Participant Flow|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
60581|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
60582|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
60583|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
60584|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
60585|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
60586|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
60587|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
60588|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
60589|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
60590|NCT02203578|E1|Reported Event|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
60591|NCT02203565|B1|Baseline|Supportive Care (Dakin's Solution, Radiation Therapy)|"Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.~Dakin's solution: Applied topically~radiation therapy: Undergo radiation therapy~questionnaire administration: Ancillary studies~laboratory biomarker analysis: Optional correlative studies"
60592|NCT02203565|P1|Participant Flow|Supportive Care (Dakin's Solution, Radiation Therapy)|"Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.~Dakin's solution: Applied topically~radiation therapy: Undergo radiation therapy~questionnaire administration: Ancillary studies~laboratory biomarker analysis: Optional correlative studies"
60593|NCT02203565|O1|Outcome|Supportive Care (Dakin's Solution, Radiation Therapy)|"Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.~Dakin's solution: Applied topically~radiation therapy: Undergo radiation therapy~questionnaire administration: Ancillary studies~laboratory biomarker analysis: Optional correlative studies"
60594|NCT02203565|E1|Reported Event|Supportive Care (Dakin's Solution, Radiation Therapy)|"Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.~Dakin's solution: Applied topically~radiation therapy: Undergo radiation therapy~questionnaire administration: Ancillary studies~laboratory biomarker analysis: Optional correlative studies"
60595|NCT02203331|B7|Baseline|Total|Total of all reporting groups
60596|NCT02203331|B6|Baseline|Placebo IVR + Placebo Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60688|NCT02203149|O1|Outcome|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1.
60597|NCT02203331|B5|Baseline|Placebo IVR + Leuprorelin Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60598|NCT02203331|B4|Baseline|ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60599|NCT02203331|B3|Baseline|ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60600|NCT02203331|B2|Baseline|ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60601|NCT02203331|B1|Baseline|LNG 40 mcg IVR + Placebo Injection|Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
60602|NCT02203331|P6|Participant Flow|Placebo IVR + Placebo Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60603|NCT02203331|P5|Participant Flow|Placebo IVR + Leuprorelin Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60604|NCT02203331|P4|Participant Flow|ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60605|NCT02203331|P3|Participant Flow|ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60606|NCT02203331|P2|Participant Flow|ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60607|NCT02203331|P1|Participant Flow|LNG 40 mcg IVR + Placebo Injection|Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
60608|NCT02203331|O6|Outcome|Placebo IVR + Placebo Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60609|NCT02203331|O5|Outcome|Placebo IVR + Leuprorelin Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60610|NCT02203331|O4|Outcome|ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60611|NCT02203331|O3|Outcome|ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60612|NCT02203331|O2|Outcome|ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60613|NCT02203331|O1|Outcome|LNG 40 mcg IVR + Placebo Injection|Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
60614|NCT02203331|O6|Outcome|Placebo IVR + Placebo Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60615|NCT02203331|O5|Outcome|Placebo IVR + Leuprorelin Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60616|NCT02203331|O4|Outcome|ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60689|NCT02203149|O2|Outcome|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1.
60617|NCT02203331|O3|Outcome|ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60618|NCT02203331|O2|Outcome|ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60619|NCT02203331|O1|Outcome|LNG 40 mcg IVR + Placebo Injection|Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
60620|NCT02203331|O6|Outcome|Placebo IVR + Placebo Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60621|NCT02203331|O5|Outcome|Placebo IVR + Leuprorelin Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60622|NCT02203331|O4|Outcome|ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60623|NCT02203331|O3|Outcome|ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60624|NCT02203331|O2|Outcome|ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60625|NCT02203331|O1|Outcome|LNG 40 mcg IVR + Placebo Injection|Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
60626|NCT02203331|O6|Outcome|Placebo IVR + Placebo Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60627|NCT02203331|O5|Outcome|Placebo IVR + Leuprorelin Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60628|NCT02203331|O4|Outcome|ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60629|NCT02203331|O3|Outcome|ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60630|NCT02203331|O2|Outcome|ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60631|NCT02203331|O1|Outcome|LNG 40 mcg IVR + Placebo Injection|Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
60632|NCT02203331|O6|Outcome|Placebo IVR + Placebo Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60633|NCT02203331|O5|Outcome|Placebo IVR + Leuprorelin Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60634|NCT02203331|O4|Outcome|ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60635|NCT02203331|O3|Outcome|ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60636|NCT02203331|O2|Outcome|ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60661|NCT02203149|B5|Baseline|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
60637|NCT02203331|O1|Outcome|LNG 40 mcg IVR + Placebo Injection|Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
60638|NCT02203331|O6|Outcome|Placebo IVR + Placebo Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60639|NCT02203331|O5|Outcome|Placebo IVR + Leuprorelin Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60640|NCT02203331|O4|Outcome|ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60641|NCT02203331|O3|Outcome|ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60642|NCT02203331|O2|Outcome|ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60643|NCT02203331|O1|Outcome|LNG 40 mcg IVR + Placebo Injection|Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
60644|NCT02203331|O6|Outcome|Placebo IVR + Placebo Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60645|NCT02203331|O5|Outcome|Placebo IVR + Leuprorelin Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60646|NCT02203331|O4|Outcome|ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60647|NCT02203331|O3|Outcome|ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60648|NCT02203331|O2|Outcome|ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60649|NCT02203331|O1|Outcome|LNG 40 mcg IVR + Placebo Injection|Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
60650|NCT02203331|E6|Reported Event|Placebo IVR + Placebo Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60651|NCT02203331|E5|Reported Event|Placebo IVR + Leuprorelin Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60652|NCT02203331|E4|Reported Event|ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60653|NCT02203331|E3|Reported Event|ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60654|NCT02203331|E2|Reported Event|ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
60655|NCT02203331|E1|Reported Event|LNG 40 mcg IVR + Placebo Injection|Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
60656|NCT02203162|B1|Baseline|Subjects|all subjects underwent cough challenge testing at baseline and after e-cig exposure
60657|NCT02203162|P1|Participant Flow|Electronic Cigarette Exposure|30 healthy subjects-adult nonsmokers
60658|NCT02203162|O1|Outcome|Electronic Cigarette Exposure|30 subjects-healthy adult nonsmokers
60659|NCT02203162|E1|Reported Event|Subjects|30 subjects-adult nonsmokers
60660|NCT02203149|B6|Baseline|Total|Total of all reporting groups
60662|NCT02203149|B4|Baseline|Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir|Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up. Afterwards, participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks during the open-label period of Part 2.
60663|NCT02203149|B3|Baseline|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
60664|NCT02203149|B2|Baseline|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
60665|NCT02203149|B1|Baseline|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
60666|NCT02203149|P5|Participant Flow|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
60667|NCT02203149|P4|Participant Flow|Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir|Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up. Afterwards, participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks during the open-label period of Part 2.
60668|NCT02203149|P3|Participant Flow|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
60669|NCT02203149|P2|Participant Flow|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
60670|NCT02203149|P1|Participant Flow|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
60671|NCT02203149|O3|Outcome|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
60672|NCT02203149|O2|Outcome|Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir|During the open-label period of Part 2, non-cirrhotic participants in the Deferred Treatment Arm take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks.
60673|NCT02203149|O1|Outcome|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
60674|NCT02203149|O3|Outcome|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
60675|NCT02203149|O2|Outcome|Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir|During the open-label period of Part 2, non-cirrhotic participants in the Deferred Treatment Arm take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks.
60676|NCT02203149|O1|Outcome|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
60677|NCT02203149|O3|Outcome|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2.
60678|NCT02203149|O2|Outcome|Part 2 Non-cirrhotic Deferred: Placebo|Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2.
60679|NCT02203149|O1|Outcome|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2.
60680|NCT02203149|O3|Outcome|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2.
60681|NCT02203149|O2|Outcome|Part 2 Non-cirrhotic Deferred: Placebo|Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.
60682|NCT02203149|O1|Outcome|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2.
60683|NCT02203149|O2|Outcome|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
60684|NCT02203149|O1|Outcome|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
60685|NCT02203149|O2|Outcome|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
60686|NCT02203149|O1|Outcome|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
60687|NCT02203149|O2|Outcome|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1.
104923|NCT01955564|E5|Reported Event|Cohort 4|NW-3509a 10 mg, single dose
60690|NCT02203149|O1|Outcome|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1.
60691|NCT02203149|O5|Outcome|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
60692|NCT02203149|O4|Outcome|Part 2 Non-cirrhotic Deferred: Placebo|Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.
60693|NCT02203149|O3|Outcome|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic treatment-naïve participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
60694|NCT02203149|O2|Outcome|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
60695|NCT02203149|O1|Outcome|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
60696|NCT02203149|E6|Reported Event|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
60697|NCT02203149|E5|Reported Event|Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir|During the open-label period, non-cirrhotic participants in the Deferred Treatment Arm take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks. One participant who received placebo during the blinded period did not receive active treatment during the open-label period.
60698|NCT02203149|E4|Reported Event|Part 2 Non-cirrhotic Deferred: Placebo|Non-cirrhotic participants in the Deferred Treatment Arm take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.
60699|NCT02203149|E3|Reported Event|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
60700|NCT02203149|E2|Reported Event|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
60701|NCT02203149|E1|Reported Event|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
60702|NCT02203032|B1|Baseline|Ustekinumab (Open Label Run-in)|All participants received ustekinumab 45 milligram (mg) (participants weighing less than or equal to [<=]100 kilogram [kg]) or 90 mg (participants weighing >100 kg) at Weeks 0 and 4. At Week 16, participants with IGA >=2 were randomized to either switch to guselkumab 100 mg at Weeks 16 and 20 and then every 8 weeks thereafter or continue on ustekinumab every 12 weeks (q12w); participants with an IGA=0 or 1 were to continue to receive open-label ustekinumab q12w.
60703|NCT02203032|P4|Participant Flow|Ustekinumab (Nonrandomized Open Label Continuation)|Participants from open label run-in phase with an IGA=0 or 1 at Week 16 received ustekinumab 45 mg or 90 mg (according to their baseline weight [Week 0]) at Weeks 16, 28, and 40.
60704|NCT02203032|P3|Participant Flow|Ustekinumab (Randomized)|Participants from open label run-in phase with an IGA >=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.
60705|NCT02203032|P2|Participant Flow|100 mg Guselkumab (Randomized)|Participants from open label run-in phase with an investigator global assessment (IGA) greater than or equal to (>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.
60706|NCT02203032|P1|Participant Flow|Ustekinumab (Open Label Run-in)|All participants received ustekinumab 45 milligram (mg) (participants weighing less than or equal to [<=]100 kilogram [kg]) or 90 mg (participants weighing >100 kg) at Weeks 0 and 4. At Week 16, participants with IGA >=2 were randomized to either switch to guselkumab 100 mg at Weeks 16 and 20 and then every 8 weeks thereafter or continue on ustekinumab every 12 weeks (q12w); participants with an IGA=0 or 1 were to continue to receive open-label ustekinumab q12w.
60707|NCT02203032|O2|Outcome|Ustekinumab (Randomized)|Participants from open label run-in phase with an IGA >=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.
60708|NCT02203032|O1|Outcome|Guselkumab (Randomized)|Participants from open label Run-in phase with an investigator global assessment (IGA) greater than or equal to (>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.
60709|NCT02203032|O2|Outcome|Ustekinumab (Randomized)|Participants from open label run-in phase with an IGA >=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.
60710|NCT02203032|O1|Outcome|Guselkumab (Randomized)|Participants from open label Run-in phase with an investigator global assessment (IGA) greater than or equal to (>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.
60711|NCT02203032|O2|Outcome|Ustekinumab (Randomized)|Participants from open label run-in phase with an IGA >=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.
60740|NCT02202980|P8|Participant Flow|SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
60712|NCT02203032|O1|Outcome|Guselkumab (Randomized)|Participants from open label Run-in phase with an investigator global assessment (IGA) greater than or equal to (>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.
60713|NCT02203032|O2|Outcome|Ustekinumab (Randomized)|Participants from open label run-in phase with an IGA >=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.
60714|NCT02203032|O1|Outcome|Guselkumab (Randomized)|Participants from open label Run-in phase with an investigator global assessment (IGA) greater than or equal to (>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.
60715|NCT02203032|E4|Reported Event|Ustekinumab (Nonrandomized Open Label Continuation)|Participants from open label run-in phase with an IGA=0 or 1 at Week 16 received ustekinumab 45 mg or 90 mg (according to their baseline weight [Week 0]) at Weeks 16, 28, and 40.
60716|NCT02203032|E3|Reported Event|Ustekinumab (Randomized)|Participants from open label run-in phase with an IGA >=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.
60717|NCT02203032|E2|Reported Event|100 mg Guselkumab (Randomized)|Participants from open label run-in phase with an investigator global assessment (IGA) greater than or equal to (>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.
60718|NCT02203032|E1|Reported Event|Ustekinumab (Open Label Run-in)|All participants received ustekinumab 45 milligram (mg) (participants weighing less than or equal to [<=]100 kilogram [kg]) or 90 mg (participants weighing >100 kg) at Weeks 0 and 4. At Week 16, participants with IGA >=2 were randomized to either switch to guselkumab 100 mg at Weeks 16 and 20 and then every 8 weeks thereafter or continue on ustekinumab every 12 weeks (q12w); participants with an IGA=0 or 1 were to continue to receive open-label ustekinumab q12w.
60719|NCT02202980|B15|Baseline|Total|Total of all reporting groups
60720|NCT02202980|B14|Baseline|SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
60721|NCT02202980|B13|Baseline|SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
60722|NCT02202980|B12|Baseline|SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
60723|NCT02202980|B11|Baseline|SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
60724|NCT02202980|B10|Baseline|SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
60725|NCT02202980|B9|Baseline|SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
60726|NCT02202980|B8|Baseline|SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
60727|NCT02202980|B7|Baseline|SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
60728|NCT02202980|B6|Baseline|SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)|VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
60729|NCT02202980|B5|Baseline|LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)|LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
60730|NCT02202980|B4|Baseline|LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)|LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
60731|NCT02202980|B3|Baseline|LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)|LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
60732|NCT02202980|B2|Baseline|LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)|LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
60733|NCT02202980|B1|Baseline|LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)|LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12
60734|NCT02202980|P14|Participant Flow|SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
60735|NCT02202980|P13|Participant Flow|SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in direct-acting antiviral (DAA)-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
60736|NCT02202980|P12|Participant Flow|SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in nonstructural protein (NS3/4A) protease inhibitor (PI)-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
60737|NCT02202980|P11|Participant Flow|SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
60738|NCT02202980|P10|Participant Flow|SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
60739|NCT02202980|P9|Participant Flow|SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
60741|NCT02202980|P7|Participant Flow|SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
60742|NCT02202980|P6|Participant Flow|SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)|Voxilaprevir (VOX) 100 mg with food on Day 1, followed by sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
60743|NCT02202980|P5|Participant Flow|LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)|LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
60744|NCT02202980|P4|Participant Flow|LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)|LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
60745|NCT02202980|P3|Participant Flow|LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)|LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
60746|NCT02202980|P2|Participant Flow|LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)|LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
60747|NCT02202980|P1|Participant Flow|LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) + ribavirin (RBV) (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving sustained virologic response at 12 weeks following treatment (SVR12)
60748|NCT02202980|O14|Outcome|SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
60749|NCT02202980|O13|Outcome|SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
60750|NCT02202980|O12|Outcome|SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
60751|NCT02202980|O11|Outcome|SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
60752|NCT02202980|O10|Outcome|SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
60753|NCT02202980|O9|Outcome|SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
60754|NCT02202980|O8|Outcome|SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
60755|NCT02202980|O7|Outcome|SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
60756|NCT02202980|O6|Outcome|SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)|VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
60757|NCT02202980|O5|Outcome|LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)|LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
60758|NCT02202980|O4|Outcome|LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)|LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
60759|NCT02202980|O3|Outcome|LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)|LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
60760|NCT02202980|O2|Outcome|LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)|LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
60761|NCT02202980|O1|Outcome|LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)|LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12
60762|NCT02202980|O14|Outcome|SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
60763|NCT02202980|O13|Outcome|SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
60764|NCT02202980|O12|Outcome|SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
60765|NCT02202980|O11|Outcome|SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
60766|NCT02202980|O10|Outcome|SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
60767|NCT02202980|O9|Outcome|SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
60768|NCT02202980|O8|Outcome|SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
60769|NCT02202980|O7|Outcome|SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
60770|NCT02202980|O6|Outcome|SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)|VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
60771|NCT02202980|O5|Outcome|LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)|LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
60772|NCT02202980|O4|Outcome|LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)|LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
60773|NCT02202980|O3|Outcome|LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)|LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
60774|NCT02202980|O2|Outcome|LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)|LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
60775|NCT02202980|O1|Outcome|LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)|LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12
60776|NCT02202980|O14|Outcome|SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
60777|NCT02202980|O13|Outcome|SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
60778|NCT02202980|O12|Outcome|SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
60779|NCT02202980|O11|Outcome|SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
60780|NCT02202980|O10|Outcome|SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
60781|NCT02202980|O9|Outcome|SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
60782|NCT02202980|O8|Outcome|SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
60783|NCT02202980|O7|Outcome|SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
60784|NCT02202980|O6|Outcome|SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)|VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
60785|NCT02202980|O5|Outcome|LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)|LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
60786|NCT02202980|O4|Outcome|LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)|LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
60787|NCT02202980|O3|Outcome|LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)|LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
60788|NCT02202980|O2|Outcome|LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)|LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
60789|NCT02202980|O1|Outcome|LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)|LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12
60790|NCT02202980|O14|Outcome|SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
60791|NCT02202980|O13|Outcome|SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
60792|NCT02202980|O12|Outcome|SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
60793|NCT02202980|O11|Outcome|SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
60794|NCT02202980|O10|Outcome|SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
60795|NCT02202980|O9|Outcome|SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
60796|NCT02202980|O8|Outcome|SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
60797|NCT02202980|O7|Outcome|SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
60798|NCT02202980|O6|Outcome|SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)|VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
60799|NCT02202980|O5|Outcome|LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)|LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
60800|NCT02202980|O4|Outcome|LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)|LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
60801|NCT02202980|O3|Outcome|LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)|LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
60802|NCT02202980|O2|Outcome|LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)|LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
60803|NCT02202980|O1|Outcome|LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)|LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12
61173|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
60804|NCT02202980|O14|Outcome|SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
60805|NCT02202980|O13|Outcome|SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
60806|NCT02202980|O12|Outcome|SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
60807|NCT02202980|O11|Outcome|SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
60808|NCT02202980|O10|Outcome|SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
60809|NCT02202980|O9|Outcome|SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
60810|NCT02202980|O8|Outcome|SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
60811|NCT02202980|O7|Outcome|SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
60812|NCT02202980|O6|Outcome|SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)|VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
60813|NCT02202980|O5|Outcome|LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)|LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
60814|NCT02202980|O4|Outcome|LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)|LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
60815|NCT02202980|O3|Outcome|LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)|LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
60816|NCT02202980|O2|Outcome|LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)|LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
60817|NCT02202980|O1|Outcome|LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)|LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12
60818|NCT02202980|E14|Reported Event|SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
60819|NCT02202980|E13|Reported Event|SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
60820|NCT02202980|E12|Reported Event|SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
60821|NCT02202980|E11|Reported Event|SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
60822|NCT02202980|E10|Reported Event|SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
60823|NCT02202980|E9|Reported Event|SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
60824|NCT02202980|E8|Reported Event|SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
60825|NCT02202980|E7|Reported Event|SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
60826|NCT02202980|E6|Reported Event|SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)|VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
60827|NCT02202980|E5|Reported Event|LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)|LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
60828|NCT02202980|E4|Reported Event|LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)|LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
60829|NCT02202980|E3|Reported Event|LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)|LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
60830|NCT02202980|E2|Reported Event|LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)|LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
60831|NCT02202980|E1|Reported Event|LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)|LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12
60832|NCT02202785|B4|Baseline|Total|Total of all reporting groups
60833|NCT02202785|B3|Baseline|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
61176|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
60834|NCT02202785|B2|Baseline|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60835|NCT02202785|B1|Baseline|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60836|NCT02202785|P3|Participant Flow|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60837|NCT02202785|P2|Participant Flow|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60838|NCT02202785|P1|Participant Flow|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60839|NCT02202785|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60840|NCT02202785|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60841|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60842|NCT02202785|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60843|NCT02202785|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60844|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60845|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
60846|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
60847|NCT02202785|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle,for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60848|NCT02202785|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60849|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60850|NCT02202785|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle,for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60851|NCT02202785|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60852|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60853|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
60854|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
60855|NCT02202785|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60856|NCT02202785|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60857|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60957|NCT02202161|O1|Outcome|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
61223|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
60858|NCT02202785|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60859|NCT02202785|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60860|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60861|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
60862|NCT02202785|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60863|NCT02202785|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60864|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60865|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
60866|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
60867|NCT02202785|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60868|NCT02202785|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60869|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60870|NCT02202785|E1|Reported Event|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
60871|NCT02202759|B4|Baseline|Total|Total of all reporting groups
63607|NCT02187016|E4|Reported Event|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
60872|NCT02202759|B3|Baseline|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60873|NCT02202759|B2|Baseline|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60874|NCT02202759|B1|Baseline|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60875|NCT02202759|P3|Participant Flow|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60876|NCT02202759|P2|Participant Flow|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60877|NCT02202759|P1|Participant Flow|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60878|NCT02202759|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60879|NCT02202759|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60880|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60881|NCT02202759|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60882|NCT02202759|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60958|NCT02202161|O1|Outcome|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
60883|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60884|NCT02202759|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60885|NCT02202759|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60886|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60887|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
60888|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
60889|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
60890|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
60891|NCT02202759|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60892|NCT02202759|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60893|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60894|NCT02202759|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60895|NCT02202759|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
61174|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
60896|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60897|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
60898|NCT02202759|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60899|NCT02202759|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60900|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60901|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
60902|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
60903|NCT02202759|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60904|NCT02202759|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60905|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60906|NCT02202759|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60907|NCT02202759|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60959|NCT02202161|O1|Outcome|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
61175|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
60908|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
60909|NCT02202759|E1|Reported Event|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
60910|NCT02202538|B1|Baseline|All Subjects|All subjects enrolled in the study used the Indego
60911|NCT02202538|P1|Participant Flow|All Subjects|All subjects enrolled in the study used the Indego
60912|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
60913|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
60914|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
60915|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
60916|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
60917|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
60918|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
60919|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
60920|NCT02202538|E1|Reported Event|All Subjects|All subjects enrolled in the study used the Indego
60921|NCT02202317|B1|Baseline|Y90 Based PET/CT Scan|PET/CT Scan: Subjects will receive a PET/CT Scan in addition to SPECT imaging, from the level of the lower chest to the lower pelvis, typical of an abdominal CT, usually within 1-3 hours after Yttrium-90 treatment.
60922|NCT02202317|P1|Participant Flow|Y90 Based PET/CT Scan|PET/CT Scan: Subjects will receive a PET/CT Scan in addition to SPECT imaging, from the level of the lower chest to the lower pelvis, typical of an abdominal CT, usually within 1-3 hours after Yttrium-90 treatment.
60923|NCT02202317|O1|Outcome|Y90 Based PET/CT Scan|PET/CT Scan: Subjects will receive a PET/CT Scan in addition to SPECT imaging, from the level of the lower chest to the lower pelvis, typical of an abdominal CT, usually within 1-3 hours after Yttrium-90 treatment.
60924|NCT02202317|O1|Outcome|Y90 Based PET/CT Scan|PET/CT Scan: Subjects will receive a PET/CT Scan in addition to SPECT imaging, from the level of the lower chest to the lower pelvis, typical of an abdominal CT, usually within 1-3 hours after Yttrium-90 treatment.
60925|NCT02202317|O1|Outcome|Y90 Based PET/CT Scan|PET/CT Scan: Subjects will receive a PET/CT Scan in addition to SPECT imaging, from the level of the lower chest to the lower pelvis, typical of an abdominal CT, usually within 1-3 hours after Yttrium-90 treatment.
60926|NCT02202317|E1|Reported Event|Y90 Based PET/CT Scan|PET/CT Scan: Subjects will receive a PET/CT Scan in addition to SPECT imaging, from the level of the lower chest to the lower pelvis, typical of an abdominal CT, usually within 1-3 hours after Yttrium-90 treatment.
60927|NCT02202252|B3|Baseline|Total|Total of all reporting groups
60928|NCT02202252|B2|Baseline|Double Drain|"Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
60929|NCT02202252|B1|Baseline|Single Drain|"Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
60930|NCT02202252|P2|Participant Flow|Double Drain|"Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
60931|NCT02202252|P1|Participant Flow|Single Drain|"Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
60932|NCT02202252|O2|Outcome|Double Drain|"Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
61119|NCT02201953|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
60933|NCT02202252|O1|Outcome|Single Drain|"Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
60934|NCT02202252|O2|Outcome|Double Drain|"Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
60935|NCT02202252|O1|Outcome|Single Drain|"Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
60936|NCT02202252|O2|Outcome|Double Drain|"Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
60937|NCT02202252|O1|Outcome|Single Drain|"Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
60938|NCT02202252|E2|Reported Event|Double Drain|Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.
60939|NCT02202252|E1|Reported Event|Single Drain|Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.
60940|NCT02202161|B9|Baseline|Total|Total of all reporting groups
60941|NCT02202161|B8|Baseline|Run-in Only|Participants were received open label metformin 850 mg tablet BID during run-in period, but were withdrawn prior to randomization. Participants swallowed the whole tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60942|NCT02202161|B7|Baseline|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
60943|NCT02202161|B6|Baseline|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60944|NCT02202161|B5|Baseline|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60945|NCT02202161|B4|Baseline|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60946|NCT02202161|B3|Baseline|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
63765|NCT02185105|O2|Outcome|Comfilcon A Toric|
60947|NCT02202161|B2|Baseline|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60948|NCT02202161|B1|Baseline|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60949|NCT02202161|P8|Participant Flow|Run-in Only|Participants were received open label metformin 850 mg tablet BID during run-in period, but were withdrawn prior to randomization. Participants swallowed the whole tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60950|NCT02202161|P7|Participant Flow|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
60951|NCT02202161|P6|Participant Flow|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60952|NCT02202161|P5|Participant Flow|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60953|NCT02202161|P4|Participant Flow|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60954|NCT02202161|P3|Participant Flow|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60955|NCT02202161|P2|Participant Flow|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60956|NCT02202161|P1|Participant Flow|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally twice daily (BID) for 14 days. Participants drank the contents of dosing bottle (45 milliliters [mL]) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61120|NCT02201953|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
61121|NCT02201953|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
60960|NCT02202161|O7|Outcome|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
60961|NCT02202161|O6|Outcome|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60962|NCT02202161|O5|Outcome|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60963|NCT02202161|O4|Outcome|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60964|NCT02202161|O3|Outcome|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60965|NCT02202161|O2|Outcome|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60966|NCT02202161|O1|Outcome|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60967|NCT02202161|O7|Outcome|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
60968|NCT02202161|O6|Outcome|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60969|NCT02202161|O5|Outcome|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61122|NCT02201953|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
63766|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
60970|NCT02202161|O4|Outcome|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60971|NCT02202161|O3|Outcome|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60972|NCT02202161|O2|Outcome|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60973|NCT02202161|O1|Outcome|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60974|NCT02202161|O7|Outcome|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
60975|NCT02202161|O6|Outcome|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60976|NCT02202161|O5|Outcome|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60977|NCT02202161|O4|Outcome|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60978|NCT02202161|O3|Outcome|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61123|NCT02201953|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
61124|NCT02201953|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
61125|NCT02201953|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
61126|NCT02201953|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
63767|NCT02185105|O2|Outcome|Comfilcon A Toric|
60979|NCT02202161|O2|Outcome|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60980|NCT02202161|O1|Outcome|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60981|NCT02202161|O7|Outcome|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
60982|NCT02202161|O6|Outcome|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60983|NCT02202161|O5|Outcome|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60984|NCT02202161|O4|Outcome|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60985|NCT02202161|O3|Outcome|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60986|NCT02202161|O2|Outcome|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60987|NCT02202161|O1|Outcome|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61127|NCT02201953|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
61128|NCT02201953|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
61129|NCT02201953|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
61130|NCT02201953|E2|Reported Event|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
63768|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
60988|NCT02202161|O7|Outcome|Sitagliptin 50 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60989|NCT02202161|O6|Outcome|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60990|NCT02202161|O5|Outcome|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60991|NCT02202161|O4|Outcome|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60992|NCT02202161|O3|Outcome|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60993|NCT02202161|O2|Outcome|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60994|NCT02202161|O1|Outcome|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60995|NCT02202161|O8|Outcome|Run-in Only|Participants were received open label metformin 850 mg tablet BID during run-in period, but were withdrawn prior to randomization. Participants swallowed the whole tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60996|NCT02202161|O7|Outcome|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
60997|NCT02202161|O6|Outcome|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61131|NCT02201953|E1|Reported Event|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
61132|NCT02201940|B3|Baseline|Total|Total of all reporting groups
61133|NCT02201940|B2|Baseline|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
60998|NCT02202161|O5|Outcome|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
60999|NCT02202161|O4|Outcome|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61000|NCT02202161|O3|Outcome|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61001|NCT02202161|O2|Outcome|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61002|NCT02202161|O1|Outcome|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61003|NCT02202161|O7|Outcome|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
61004|NCT02202161|O6|Outcome|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61005|NCT02202161|O5|Outcome|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61006|NCT02202161|O4|Outcome|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61134|NCT02201940|B1|Baseline|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
61135|NCT02201940|P2|Participant Flow|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
61136|NCT02201940|P1|Participant Flow|SOF/VEL|Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered orally once daily for 12 weeks
61137|NCT02201940|O2|Outcome|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
61138|NCT02201940|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
61007|NCT02202161|O3|Outcome|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61008|NCT02202161|O2|Outcome|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61009|NCT02202161|O1|Outcome|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61010|NCT02202161|O7|Outcome|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
61011|NCT02202161|O6|Outcome|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61012|NCT02202161|O5|Outcome|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61013|NCT02202161|O4|Outcome|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61014|NCT02202161|O3|Outcome|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61015|NCT02202161|O2|Outcome|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61139|NCT02201940|O2|Outcome|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
61140|NCT02201940|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
61141|NCT02201940|O2|Outcome|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
61142|NCT02201940|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
61143|NCT02201940|O2|Outcome|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
61016|NCT02202161|O1|Outcome|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61017|NCT02202161|O8|Outcome|Run-in Only|Participants were received open label metformin 850 mg tablet BID during run-in period, but were withdrawn prior to randomization. Participants swallowed the whole tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61018|NCT02202161|O7|Outcome|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
61019|NCT02202161|O6|Outcome|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61020|NCT02202161|O5|Outcome|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61021|NCT02202161|O4|Outcome|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61022|NCT02202161|O3|Outcome|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61023|NCT02202161|O2|Outcome|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61024|NCT02202161|O1|Outcome|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61025|NCT02202161|O7|Outcome|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
61026|NCT02202161|O6|Outcome|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61027|NCT02202161|O5|Outcome|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61028|NCT02202161|O4|Outcome|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61029|NCT02202161|O3|Outcome|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61030|NCT02202161|O2|Outcome|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61031|NCT02202161|O1|Outcome|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61032|NCT02202161|O7|Outcome|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
61033|NCT02202161|O6|Outcome|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61034|NCT02202161|O5|Outcome|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61035|NCT02202161|O4|Outcome|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61144|NCT02201940|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
61145|NCT02201940|O2|Outcome|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
61146|NCT02201940|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
61147|NCT02201940|O2|Outcome|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
61148|NCT02201940|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
61036|NCT02202161|O3|Outcome|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61037|NCT02202161|O2|Outcome|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61038|NCT02202161|O1|Outcome|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61039|NCT02202161|O7|Outcome|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
61040|NCT02202161|O6|Outcome|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61041|NCT02202161|O5|Outcome|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61042|NCT02202161|O4|Outcome|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61043|NCT02202161|O3|Outcome|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61044|NCT02202161|O2|Outcome|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61149|NCT02201940|E2|Reported Event|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
61150|NCT02201940|E1|Reported Event|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
61151|NCT02201901|B4|Baseline|Total|Total of all reporting groups
61152|NCT02201901|B3|Baseline|SOF/VEL 24 Weeks ((Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
61153|NCT02201901|B2|Baseline|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + Ribavirin (RBV) tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
61045|NCT02202161|O1|Outcome|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61046|NCT02202161|O7|Outcome|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
61047|NCT02202161|O6|Outcome|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61048|NCT02202161|O5|Outcome|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61049|NCT02202161|O4|Outcome|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61050|NCT02202161|O3|Outcome|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61051|NCT02202161|O2|Outcome|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61052|NCT02202161|O1|Outcome|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61053|NCT02202161|O7|Outcome|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
61054|NCT02202161|O6|Outcome|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61154|NCT02201901|B1|Baseline|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (Sofosbuvir/velpatasvir) (400/100 mg) fixed dose combination (FDC) tablet once daily for 12 weeks
63769|NCT02185105|O2|Outcome|Comfilcon A Toric|
61055|NCT02202161|O5|Outcome|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61056|NCT02202161|O4|Outcome|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61057|NCT02202161|O3|Outcome|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61058|NCT02202161|O2|Outcome|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61059|NCT02202161|O1|Outcome|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61060|NCT02202161|O7|Outcome|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
61061|NCT02202161|O6|Outcome|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61062|NCT02202161|O5|Outcome|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61063|NCT02202161|O4|Outcome|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61155|NCT02201901|P3|Participant Flow|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
61156|NCT02201901|P2|Participant Flow|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + Ribavirin (RBV) tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
61157|NCT02201901|P1|Participant Flow|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (Sofosbuvir/velpatasvir) (400/100 mg) fixed dose combination (FDC) tablet once daily for 12 weeks
61158|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
61064|NCT02202161|O3|Outcome|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61065|NCT02202161|O2|Outcome|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61066|NCT02202161|O1|Outcome|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61067|NCT02202161|O7|Outcome|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
61068|NCT02202161|O6|Outcome|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61069|NCT02202161|O5|Outcome|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61070|NCT02202161|O4|Outcome|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61071|NCT02202161|O3|Outcome|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61072|NCT02202161|O2|Outcome|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61159|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
61160|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
61161|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
61162|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
61073|NCT02202161|O1|Outcome|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61074|NCT02202161|O7|Outcome|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
61075|NCT02202161|O6|Outcome|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61076|NCT02202161|O5|Outcome|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61077|NCT02202161|O4|Outcome|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61078|NCT02202161|O3|Outcome|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61079|NCT02202161|O2|Outcome|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61080|NCT02202161|O1|Outcome|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61081|NCT02202161|O7|Outcome|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
61082|NCT02202161|O6|Outcome|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61163|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
61164|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
61083|NCT02202161|O5|Outcome|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61084|NCT02202161|O4|Outcome|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61085|NCT02202161|O3|Outcome|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61086|NCT02202161|O2|Outcome|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61087|NCT02202161|O1|Outcome|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61088|NCT02202161|O7|Outcome|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
61089|NCT02202161|O6|Outcome|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61090|NCT02202161|O5|Outcome|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61091|NCT02202161|O4|Outcome|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61165|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
61166|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
61167|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
61168|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
61092|NCT02202161|O3|Outcome|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61093|NCT02202161|O2|Outcome|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61094|NCT02202161|O1|Outcome|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61095|NCT02202161|O7|Outcome|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
61096|NCT02202161|O6|Outcome|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61097|NCT02202161|O5|Outcome|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61098|NCT02202161|O4|Outcome|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61099|NCT02202161|O3|Outcome|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61100|NCT02202161|O2|Outcome|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61169|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
61170|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
61171|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
61172|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
63770|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
61101|NCT02202161|O1|Outcome|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61102|NCT02202161|E7|Reported Event|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
61103|NCT02202161|E6|Reported Event|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61104|NCT02202161|E5|Reported Event|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61105|NCT02202161|E4|Reported Event|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61106|NCT02202161|E3|Reported Event|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61107|NCT02202161|E2|Reported Event|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61108|NCT02202161|E1|Reported Event|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
61109|NCT02202135|B1|Baseline|Ceftaroline|Ceftaroline fosamil 600 mg 120 min
61110|NCT02202135|P1|Participant Flow|Ceftaroline|Ceftaroline fosamil 600 mg 120 min
61111|NCT02202135|O1|Outcome|Ceftaroline|Ceftaroline fosamil 600 mg 120 min
61112|NCT02202135|E1|Reported Event|Ceftaroline|Ceftaroline fosamil 600 mg 120 min
61113|NCT02201953|B3|Baseline|Total|Total of all reporting groups
61114|NCT02201953|B2|Baseline|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
61115|NCT02201953|B1|Baseline|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
61116|NCT02201953|P2|Participant Flow|SOF+RBV 24 Weeks|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
61117|NCT02201953|P1|Participant Flow|SOF/VEL 12 Weeks|Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered orally once daily for 12 weeks
61118|NCT02201953|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
61177|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
61178|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
61179|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
61180|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
61181|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
61182|NCT02201901|E3|Reported Event|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
61183|NCT02201901|E2|Reported Event|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
61184|NCT02201901|E1|Reported Event|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
61185|NCT02201784|B3|Baseline|Total|Total of all reporting groups
61186|NCT02201784|B2|Baseline|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
61187|NCT02201784|B1|Baseline|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
61188|NCT02201784|P2|Participant Flow|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
61189|NCT02201784|P1|Participant Flow|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
61190|NCT02201784|O2|Outcome|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
61191|NCT02201784|O1|Outcome|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
61192|NCT02201784|O2|Outcome|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
61193|NCT02201784|O1|Outcome|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
61194|NCT02201784|O2|Outcome|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
61195|NCT02201784|O1|Outcome|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
61196|NCT02201784|O2|Outcome|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
61197|NCT02201784|O1|Outcome|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
61198|NCT02201784|O2|Outcome|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
61199|NCT02201784|O1|Outcome|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
61200|NCT02201784|E2|Reported Event|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
61201|NCT02201784|E1|Reported Event|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
61202|NCT02201524|B5|Baseline|Total|Total of all reporting groups
61203|NCT02201524|B4|Baseline|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
61204|NCT02201524|B3|Baseline|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
61205|NCT02201524|B2|Baseline|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
61206|NCT02201524|B1|Baseline|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
61207|NCT02201524|P4|Participant Flow|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
61208|NCT02201524|P3|Participant Flow|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
61209|NCT02201524|P2|Participant Flow|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
61210|NCT02201524|P1|Participant Flow|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
61211|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
61212|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
61213|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
61214|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
61215|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
61216|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
61217|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
61218|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
61219|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
61220|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
61221|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
61222|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
61224|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
61225|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
61226|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
61227|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
61228|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
61229|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
61230|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
61231|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
61232|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
61233|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
61234|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
61235|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
61236|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
61237|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
61238|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
61239|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
61240|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
61241|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
61242|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
61243|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
61244|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
61245|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
61246|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
61247|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
61248|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
61249|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
61250|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
61251|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
61252|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
61253|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
61254|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
61255|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
61256|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
61257|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
61258|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
61259|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
61260|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
61261|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
61262|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
61263|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
61264|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
61265|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
61266|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
61267|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
61268|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
61269|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
63771|NCT02185105|O2|Outcome|Comfilcon A Toric|
61270|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
61271|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
61272|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
61273|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
61274|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
61275|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
61276|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
61277|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
61278|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
61279|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
61280|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
61281|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
61282|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
61283|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
61284|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
61285|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
61286|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
61287|NCT02201524|E4|Reported Event|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
61288|NCT02201524|E3|Reported Event|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
61289|NCT02201524|E2|Reported Event|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
61290|NCT02201524|E1|Reported Event|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
61291|NCT02201446|B3|Baseline|Total|Total of all reporting groups
61292|NCT02201446|B2|Baseline|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
61293|NCT02201446|B1|Baseline|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
61294|NCT02201446|P2|Participant Flow|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
61295|NCT02201446|P1|Participant Flow|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
61296|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
61297|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
61298|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
61299|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
61300|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
61301|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
61302|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
61325|NCT02201420|O1|Outcome|Tc 99m Tilmanocept|"Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging.~Tc 99m tilmanocept"
61387|NCT02201056|O1|Outcome|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
61303|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
61304|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
61305|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
61306|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
61307|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
61308|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
61309|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
61310|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
61311|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
61312|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
61313|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
61314|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
61315|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
61316|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
61317|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
61318|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
61319|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
61320|NCT02201446|E2|Reported Event|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
61321|NCT02201446|E1|Reported Event|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
61322|NCT02201420|B1|Baseline|Tc 99m Tilmanocept|"Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging.~Tc 99m tilmanocept"
61323|NCT02201420|P1|Participant Flow|Tc 99m Tilmanocept|"Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging.~Tc 99m tilmanocept"
61324|NCT02201420|O1|Outcome|Tc 99m Tilmanocept|"Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging.~Tc 99m tilmanocept"
61384|NCT02201056|O4|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
61326|NCT02201420|E1|Reported Event|Tc 99m Tilmanocept|"Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging.~Tc 99m tilmanocept"
61327|NCT02201394|B1|Baseline|Patients With Stable CVD|DAPT loading dose (Ticagrelor (180 mg) + ASA (325 mg)); DAPT maintenance therapy (Ticagrelor (90 mg BID) + ASA (81 mg OD), for one week (in same patients)
61328|NCT02201394|P1|Participant Flow|Patients With Stable CVD|DAPT loading dose (Ticagrelor (180 mg) + ASA (325 mg)); DAPT maintenance therapy (Ticagrelor (90 mg BID) + ASA (81 mg OD), for one week (in same patients)
61329|NCT02201394|O2|Outcome|Maintenance Dose|Ticagrelor (90 mg BID) + ASA (81 mg OD), for one week
61330|NCT02201394|O1|Outcome|Loading Dose|Ticagrelor (180 mg) + ASA (325 mg).
61331|NCT02201394|O2|Outcome|Maintenance Dose|Ticagrelor (90 mg BID) + ASA (81 mg OD), for one week
61332|NCT02201394|O1|Outcome|Loading Dose|Ticagrelor (180 mg) + ASA (325 mg).
61333|NCT02201394|E1|Reported Event|Patients With Stable CVD|DAPT loading dose (Ticagrelor (180 mg) + ASA (325 mg)); DAPT maintenance therapy (Ticagrelor (90 mg BID) + ASA (81 mg OD), for one week (in same patients)
61334|NCT02201056|B8|Baseline|Total|Total of all reporting groups
61335|NCT02201056|B7|Baseline|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
61336|NCT02201056|B6|Baseline|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
61337|NCT02201056|B5|Baseline|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
61338|NCT02201056|B4|Baseline|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
61339|NCT02201056|B3|Baseline|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
61340|NCT02201056|B2|Baseline|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
61341|NCT02201056|B1|Baseline|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
61342|NCT02201056|P7|Participant Flow|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
61343|NCT02201056|P6|Participant Flow|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
61344|NCT02201056|P5|Participant Flow|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
61345|NCT02201056|P4|Participant Flow|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
61346|NCT02201056|P3|Participant Flow|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
61347|NCT02201056|P2|Participant Flow|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
61348|NCT02201056|P1|Participant Flow|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
61349|NCT02201056|O6|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
61350|NCT02201056|O5|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
61351|NCT02201056|O4|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
61352|NCT02201056|O3|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
61353|NCT02201056|O2|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
61354|NCT02201056|O1|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
61355|NCT02201056|O6|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
61356|NCT02201056|O5|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
61357|NCT02201056|O4|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
61358|NCT02201056|O3|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
61359|NCT02201056|O2|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
61360|NCT02201056|O1|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
61361|NCT02201056|O6|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
61362|NCT02201056|O5|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
61363|NCT02201056|O4|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
61364|NCT02201056|O3|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
61365|NCT02201056|O2|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
61366|NCT02201056|O1|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
61367|NCT02201056|O7|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
61368|NCT02201056|O6|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
61369|NCT02201056|O5|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
61370|NCT02201056|O4|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
61371|NCT02201056|O3|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
61372|NCT02201056|O2|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
61373|NCT02201056|O1|Outcome|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
61374|NCT02201056|O7|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
61375|NCT02201056|O6|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
61376|NCT02201056|O5|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
61377|NCT02201056|O4|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
61378|NCT02201056|O3|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
61379|NCT02201056|O2|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
61380|NCT02201056|O1|Outcome|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
61381|NCT02201056|O7|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
61382|NCT02201056|O6|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
61383|NCT02201056|O5|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
61394|NCT02201056|O1|Outcome|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
61395|NCT02201056|E7|Reported Event|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
61396|NCT02201056|E6|Reported Event|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
61397|NCT02201056|E5|Reported Event|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
61398|NCT02201056|E4|Reported Event|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
61399|NCT02201056|E3|Reported Event|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
61400|NCT02201056|E2|Reported Event|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
61401|NCT02201056|E1|Reported Event|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
61402|NCT02200536|B4|Baseline|Total|Total of all reporting groups
61403|NCT02200536|B3|Baseline|Control 2|No intervention.
61404|NCT02200536|B2|Baseline|Control 1|"Infant oral health pamphlet~Infant oral health pamphlet: Infant oral health pamphlet"
61405|NCT02200536|B1|Baseline|Test|"Infant oral health promotion package~Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup."
61406|NCT02200536|P3|Participant Flow|Control 2|No intervention.
61407|NCT02200536|P2|Participant Flow|Control 1|"Infant oral health pamphlet~Infant oral health pamphlet: Infant oral health pamphlet"
61408|NCT02200536|P1|Participant Flow|Test|"Infant oral health promotion package~Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup."
61409|NCT02200536|O3|Outcome|Control 2|No intervention.
61410|NCT02200536|O2|Outcome|Control 1|"Infant oral health pamphlet~Infant oral health pamphlet: Infant oral health pamphlet"
61411|NCT02200536|O1|Outcome|Test|"Infant oral health promotion package~Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup."
61412|NCT02200536|O3|Outcome|Control 2|No intervention.
61413|NCT02200536|O2|Outcome|Control 1|"Infant oral health pamphlet~Infant oral health pamphlet: Infant oral health pamphlet"
61414|NCT02200536|O1|Outcome|Test|"Infant oral health promotion package~Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup."
61415|NCT02200536|E3|Reported Event|Control 2|No intervention.
61416|NCT02200536|E2|Reported Event|Control 1|"Infant oral health pamphlet~Infant oral health pamphlet: Infant oral health pamphlet"
61417|NCT02200536|E1|Reported Event|Test|"Infant oral health promotion package~Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup."
61418|NCT02200458|B1|Baseline|VeinViewer|"Vascular imaging technology will be used to visualize peripheral vasculature.~VeinViewer"
61419|NCT02200458|P1|Participant Flow|VeinViewer|"Vascular imaging technology will be used to visualize peripheral vasculature.~VeinViewer"
61420|NCT02200458|O1|Outcome|VeinViewer|"Vascular imaging technology will be used to visualize peripheral vasculature.~VeinViewer"
61421|NCT02200458|E1|Reported Event|VeinViewer|"Vascular imaging technology will be used to visualize peripheral vasculature.~VeinViewer"
61422|NCT02200328|B3|Baseline|Total|Total of all reporting groups
61423|NCT02200328|B2|Baseline|Placebo|"Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days~Placebo: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days"
61424|NCT02200328|B1|Baseline|Metronidazole|"Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days~Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days"
61425|NCT02200328|P2|Participant Flow|Placebo|"Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days~Placebo: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days"
61426|NCT02200328|P1|Participant Flow|Metronidazole|"Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days~Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days"
61427|NCT02200328|O2|Outcome|Placebo|"Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days~Placebo: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days"
61428|NCT02200328|O1|Outcome|Metronidazole|"Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days~Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days"
61429|NCT02200328|O2|Outcome|Placebo|"Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days~Placebo: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days"
61430|NCT02200328|O1|Outcome|Metronidazole|"Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days~Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days"
61431|NCT02200328|E2|Reported Event|Placebo|"Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days~Placebo: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days"
61432|NCT02200328|E1|Reported Event|Metronidazole|"Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days~Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days"
61433|NCT02199795|B3|Baseline|Total|Total of all reporting groups
61434|NCT02199795|B2|Baseline|Cyclic NMES|"Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.~Cyclic Neuromuscular Electrical Stimulation"
61459|NCT02199574|O1|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL: Protocol was amended after a single subject received a dose of 266 mg EXPAREL to a dose level of 133 mg EXPAREL."
61460|NCT02199574|O1|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL: Protocol was amended after a single subject received a dose of 266 mg EXPAREL to a dose level of 133 mg EXPAREL."
61530|NCT02198235|B3|Baseline|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
61435|NCT02199795|B1|Baseline|CCNMES|"Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax.~Contralaterally Controlled Neuromuscular Electrical Stimulation"
61436|NCT02199795|P2|Participant Flow|Cyclic NMES|"Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.~Cyclic Neuromuscular Electrical Stimulation"
61437|NCT02199795|P1|Participant Flow|CCNMES|"Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax.~Contralaterally Controlled Neuromuscular Electrical Stimulation"
61438|NCT02199795|O2|Outcome|Cyclic NMES|"Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.~Cyclic Neuromuscular Electrical Stimulation"
61439|NCT02199795|O1|Outcome|CCNMES|"Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax.~Contralaterally Controlled Neuromuscular Electrical Stimulation"
61440|NCT02199795|O2|Outcome|Cyclic NMES|"Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.~Cyclic Neuromuscular Electrical Stimulation"
61441|NCT02199795|O1|Outcome|CCNMES|"Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax.~Contralaterally Controlled Neuromuscular Electrical Stimulation"
61442|NCT02199795|O2|Outcome|Cyclic NMES|"Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.~Cyclic Neuromuscular Electrical Stimulation"
61443|NCT02199795|O1|Outcome|CCNMES|"Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax.~Contralaterally Controlled Neuromuscular Electrical Stimulation"
61444|NCT02199795|O2|Outcome|Cyclic NMES|"Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.~Cyclic Neuromuscular Electrical Stimulation"
61445|NCT02199795|O1|Outcome|CCNMES|"Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax.~Contralaterally Controlled Neuromuscular Electrical Stimulation"
61446|NCT02199795|E2|Reported Event|Cyclic NMES|"Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.~Cyclic Neuromuscular Electrical Stimulation"
61447|NCT02199795|E1|Reported Event|CCNMES|"Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax.~Contralaterally Controlled Neuromuscular Electrical Stimulation"
61448|NCT02199717|B1|Baseline|Boys With Hemophilia|
61449|NCT02199717|P1|Participant Flow|Boys With Hemophilia|Use of accelerometer for 1 week
61450|NCT02199717|O2|Outcome|Mild/Moderate Hemophilia|Mild/Moderate Hemophilia
61451|NCT02199717|O1|Outcome|Severe Hemophilia|Severe Hemophilia
61452|NCT02199717|O2|Outcome|Mild/Moderate Hemophilia|Mild/Moderate Hemophilia
61453|NCT02199717|O1|Outcome|Severe Hemophilia|Severe Hemophilia
61454|NCT02199717|E1|Reported Event|Severe Hemophilia|
61455|NCT02199574|B1|Baseline|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL: Protocol was amended after a single subject received a dose of 266 mg EXPAREL to a dose level of 133 mg EXPAREL."
61456|NCT02199574|P1|Participant Flow|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL"
61457|NCT02199574|O1|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL"
61458|NCT02199574|O1|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL"
63772|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
61461|NCT02199574|O1|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL: Protocol was amended after a single subject received a dose of 266 mg EXPAREL to a dose level of 133 mg EXPAREL."
61462|NCT02199574|O1|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL: 133 mg EXPAREL in 10 mL."
61463|NCT02199574|E1|Reported Event|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL"
61464|NCT02199509|B1|Baseline|Primary Oromandibular Dystonia or Cranial Dystonia|All participants enrolled in the study.
61465|NCT02199509|P2|Participant Flow|Placebo Then Levetiracetam Group|Patients with Primary Oromandibular Dystonia or Cervical Dystonia were given Placebo for maximum dose for three weeks followed by Levetiracetam.
61466|NCT02199509|P1|Participant Flow|Levetiracetam Then Placebo Group|Patients with Primary Oromandibular Dystonia or Cervical Dystonia were given Levetiracetam at maximum tolerated dose for three weeks followed by a Placebo.
61467|NCT02199509|O4|Outcome|Placebo Group at 6 or 14 Weeks|Subjects received a starting dose of 500 mg twice daily of placebo. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
61468|NCT02199509|O3|Outcome|Placebo Group at 3 or 11 Weeks|Subjects received a starting dose of 500 mg twice daily of placebo. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
61469|NCT02199509|O2|Outcome|Levetiracetam Group at 6 or 14 Weeks|Subjects received a starting dose of 500 mg twice daily of levetiracetam. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
61470|NCT02199509|O1|Outcome|Levetiracetam Group at 3 or 11 Weeks|Subjects received a starting dose of 500 mg twice daily of levetiracetam. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
61471|NCT02199509|O2|Outcome|Placebo Group|Subjects received a starting dose of 500 mg twice daily of placebo. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
61472|NCT02199509|O1|Outcome|Levetiracetam Group|Subjects received a starting dose of 500 mg twice daily of levetiracetam. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
61473|NCT02199509|O2|Outcome|Placebo Group|Subjects received a starting dose of 500 mg twice daily of placebo. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
61524|NCT02198430|O1|Outcome|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
61525|NCT02198430|O2|Outcome|Control Group|Children without hemophilia
61526|NCT02198430|O1|Outcome|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
61474|NCT02199509|O1|Outcome|Levetiracetam Group|Subjects received a starting dose of 500 mg twice daily of levetiracetam. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
61475|NCT02199509|E2|Reported Event|Placebo|Subjects received a starting dose of 500 mg twice daily of placebo. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
61476|NCT02199509|E1|Reported Event|Levetiracetam|Subjects received a starting dose of 500 mg twice daily of levetiracetam. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
61477|NCT02199041|B1|Baseline|Treatment|"Interventions: cyclophosphamide, thiotepa, fludarabine, melphalan, mesna, G-CSF, mycophenolate mofetil, tacrolimus, methylprednisolone, total lymphoid irradiation, and lymphocyte infusions.~Cells for infusion are prepared using the CliniMACS System.~Prior to stem cell infusion, participants receive a preparative regimen of total lymphoid irradiation (TLI), fludarabine, cyclophosphamide, melphalan, and thiotepa to prepare their bone marrow. Thereafter, they will receive a hematopoietic cell graft from a haploidentical donor and an unrelated umbilical cord blood donor. Post-transplantation immunosuppressive treatment will include tacrolimus and mycophenolate mofetil."
61478|NCT02199041|P1|Participant Flow|Treatment|"Interventions: cyclophosphamide, thiotepa, fludarabine, melphalan, mesna, granulocyte colony-stimulating factor (G-CSF), mycophenolate mofetil, tacrolimus, methylprednisolone, total lymphoid irradiation, and lymphocyte infusions.~Cells for infusion are prepared using the CliniMACS System.~Prior to stem cell infusion, participants receive a preparative regimen of total lymphoid irradiation (TLI), fludarabine, cyclophosphamide, melphalan, and thiotepa to prepare their bone marrow. Thereafter, they will receive a hematopoietic cell graft from a haploidentical donor and an unrelated umbilical cord blood donor. Post-transplantation immunosuppressive treatment will include tacrolimus and mycophenolate mofetil."
61479|NCT02199041|O1|Outcome|Treatment|"Interventions: cyclophosphamide, thiotepa, fludarabine, melphalan, mesna, G-CSF, mycophenolate mofetil, tacrolimus, methylprednisolone, total lymphoid irradiation, and lymphocyte infusions.~Cells for infusion are prepared using the CliniMACS System.~Prior to stem cell infusion, participants receive a preparative regimen of total lymphoid irradiation (TLI), fludarabine, cyclophosphamide, melphalan, and thiotepa to prepare their bone marrow. Thereafter, they will receive a hematopoietic cell graft from a haploidentical donor and an unrelated umbilical cord blood donor. Post-transplantation immunosuppressive treatment will include tacrolimus and mycophenolate mofetil."
61480|NCT02199041|O1|Outcome|Treatment|"Interventions: cyclophosphamide, thiotepa, fludarabine, melphalan, mesna, G-CSF, mycophenolate mofetil, tacrolimus, methylprednisolone, total lymphoid irradiation, and lymphocyte infusions.~Cells for infusion are prepared using the CliniMACS System.~Prior to stem cell infusion, participants receive a preparative regimen of total lymphoid irradiation (TLI), fludarabine, cyclophosphamide, melphalan, and thiotepa to prepare their bone marrow. Thereafter, they will receive a hematopoietic cell graft from a haploidentical donor and an unrelated umbilical cord blood donor. Post-transplantation immunosuppressive treatment will include tacrolimus and mycophenolate mofetil."
61481|NCT02199041|O1|Outcome|Treatment|"Interventions: cyclophosphamide, thiotepa, fludarabine, melphalan, mesna, G-CSF, mycophenolate mofetil, tacrolimus, methylprednisolone, total lymphoid irradiation, and lymphocyte infusions.~Cells for infusion are prepared using the CliniMACS System.~Prior to stem cell infusion, participants receive a preparative regimen of total lymphoid irradiation (TLI), fludarabine, cyclophosphamide, melphalan, and thiotepa to prepare their bone marrow. Thereafter, they will receive a hematopoietic cell graft from a haploidentical donor and an unrelated umbilical cord blood donor. Post-transplantation immunosuppressive treatment will include tacrolimus and mycophenolate mofetil."
61482|NCT02199041|O1|Outcome|Treatment|"Interventions: cyclophosphamide, thiotepa, fludarabine, melphalan, mesna, G-CSF, mycophenolate mofetil, tacrolimus, methylprednisolone, total lymphoid irradiation, and lymphocyte infusions.~Cells for infusion are prepared using the CliniMACS System.~Prior to stem cell infusion, participants receive a preparative regimen of total lymphoid irradiation (TLI), fludarabine, cyclophosphamide, melphalan, and thiotepa to prepare their bone marrow. Thereafter, they will receive a hematopoietic cell graft from a haploidentical donor and an unrelated umbilical cord blood donor. Post-transplantation immunosuppressive treatment will include tacrolimus and mycophenolate mofetil."
61483|NCT02199041|O1|Outcome|Treatment|"Interventions: cyclophosphamide, thiotepa, fludarabine, melphalan, mesna, G-CSF, mycophenolate mofetil, tacrolimus, methylprednisolone, total lymphoid irradiation, and lymphocyte infusions.~Cells for infusion are prepared using the CliniMACS System.~Prior to stem cell infusion, participants receive a preparative regimen of total lymphoid irradiation (TLI), fludarabine, cyclophosphamide, melphalan, and thiotepa to prepare their bone marrow. Thereafter, they will receive a hematopoietic cell graft from a haploidentical donor and an unrelated umbilical cord blood donor. Post-transplantation immunosuppressive treatment will include tacrolimus and mycophenolate mofetil."
61527|NCT02198430|E2|Reported Event|Control Group|Children without hemophilia
61484|NCT02199041|O1|Outcome|Treatment|"Interventions: cyclophosphamide, thiotepa, fludarabine, melphalan, mesna, G-CSF, mycophenolate mofetil, tacrolimus, methylprednisolone, total lymphoid irradiation, and lymphocyte infusions.~Cells for infusion are prepared using the CliniMACS System.~Prior to stem cell infusion, participants receive a preparative regimen of total lymphoid irradiation (TLI), fludarabine, cyclophosphamide, melphalan, and thiotepa to prepare their bone marrow. Thereafter, they will receive a hematopoietic cell graft from a haploidentical donor and an unrelated umbilical cord blood donor. Post-transplantation immunosuppressive treatment will include tacrolimus and mycophenolate mofetil."
61485|NCT02199041|O1|Outcome|Treatment|"Interventions: cyclophosphamide, thiotepa, fludarabine, melphalan, mesna, G-CSF, mycophenolate mofetil, tacrolimus, methylprednisolone, total lymphoid irradiation, and lymphocyte infusions.~Cells for infusion are prepared using the CliniMACS System.~Prior to stem cell infusion, participants receive a preparative regimen of total lymphoid irradiation (TLI), fludarabine, cyclophosphamide, melphalan, and thiotepa to prepare their bone marrow. Thereafter, they will receive a hematopoietic cell graft from a haploidentical donor and an unrelated umbilical cord blood donor. Post-transplantation immunosuppressive treatment will include tacrolimus and mycophenolate mofetil."
61486|NCT02199041|O1|Outcome|Treatment|"Interventions: cyclophosphamide, thiotepa, fludarabine, melphalan, mesna, G-CSF, mycophenolate mofetil, tacrolimus, methylprednisolone, total lymphoid irradiation, and lymphocyte infusions.~Cells for infusion are prepared using the CliniMACS System.~Prior to stem cell infusion, participants receive a preparative regimen of total lymphoid irradiation (TLI), fludarabine, cyclophosphamide, melphalan, and thiotepa to prepare their bone marrow. Thereafter, they will receive a hematopoietic cell graft from a haploidentical donor and an unrelated umbilical cord blood donor. Post-transplantation immunosuppressive treatment will include tacrolimus and mycophenolate mofetil."
61487|NCT02199041|O1|Outcome|Treatment|"Interventions: cyclophosphamide, thiotepa, fludarabine, melphalan, mesna, G-CSF, mycophenolate mofetil, tacrolimus, methylprednisolone, total lymphoid irradiation, and lymphocyte infusions.~Cells for infusion are prepared using the CliniMACS System.~Prior to stem cell infusion, participants receive a preparative regimen of total lymphoid irradiation (TLI), fludarabine, cyclophosphamide, melphalan, and thiotepa to prepare their bone marrow. Thereafter, they will receive a hematopoietic cell graft from a haploidentical donor and an unrelated umbilical cord blood donor. Post-transplantation immunosuppressive treatment will include tacrolimus and mycophenolate mofetil."
61488|NCT02199041|E2|Reported Event|Blood Donors|Blood donors were enrolled on the study to provide cells for transplantation used in the Treatment Arm.
61489|NCT02199041|E1|Reported Event|Treatment|"Interventions: cyclophosphamide, thiotepa, fludarabine, melphalan, mesna, G-CSF, mycophenolate mofetil, tacrolimus, methylprednisolone, total lymphoid irradiation, and lymphocyte infusions.~Cells for infusion are prepared using the CliniMACS System.~Prior to stem cell infusion, participants receive a preparative regimen of total lymphoid irradiation (TLI), fludarabine, cyclophosphamide, melphalan, and thiotepa to prepare their bone marrow. Thereafter, they will receive a hematopoietic cell graft from a haploidentical donor and an unrelated umbilical cord blood donor. Post-transplantation immunosuppressive treatment will include tacrolimus and mycophenolate mofetil."
61490|NCT02198963|B1|Baseline|RUT058-60 vs Negative and Positve Controls|All subjects who were enrolled, remained compliant and participated in all scheduled visits and received all study material applications were analyzed.
61491|NCT02198963|P1|Participant Flow|RUT058-60 vs Negative Control vs Positive Control|Each subject was their own control and received occlusive patches containing approximately 200 mg of all three (test article, negative control, and positive control) applied to abraded and non abraded skin sites in the scapular region of each subject's back.
61492|NCT02198963|O6|Outcome|Physiological Saline (0.9%), USP- Non-Abraded|0.02 mL of the Negative Control applied to non-abraded skin sites.
61493|NCT02198963|O5|Outcome|Sodium Lauryl Sulfate (0.1%)- Non-Abraded|0.02 mL of the Positive Control applied to non-abraded skin sites.
61494|NCT02198963|O4|Outcome|Hypochlorous Acid Solution 106 mg/L- Non-Abraded|0.02 mL of the Test Product RUT058-60 applied to non-abraded skin sites.
61495|NCT02198963|O3|Outcome|Physiological Saline (0.9%), USP-Abraded|0.02 mL of the Negative Control applied to abraded skin sites.
61496|NCT02198963|O2|Outcome|Sodium Lauryl Sulfate (0.1%) -Abraded|0.02 mL of the Positive Control applied to abraded skin sites.
61497|NCT02198963|O1|Outcome|Hypochlorous Acid Solution 106 mg/L-Abraded|0.02 mL of the Test Product RUT058-60 applied to abraded skin sites.
61498|NCT02198963|E1|Reported Event|RUT058-60 vs Negative and Positve Controls|All subjects who were enrolled, remained compliant and participated in all scheduled visits and received all study material applications were analyzed.
61499|NCT02198833|B3|Baseline|Total|Total of all reporting groups
61500|NCT02198833|B2|Baseline|Standard-of-Care Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
61501|NCT02198833|B1|Baseline|Micro-Patterned Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
61502|NCT02198833|P2|Participant Flow|Standard-of-Care Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
61528|NCT02198430|E1|Reported Event|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
61529|NCT02198235|B4|Baseline|Total|Total of all reporting groups
63773|NCT02185105|O2|Outcome|Comfilcon A Toric|
61503|NCT02198833|P1|Participant Flow|Micro-Patterned Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
61504|NCT02198833|O2|Outcome|Standard-of-Care Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
61505|NCT02198833|O1|Outcome|Micro-Patterned Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
61506|NCT02198833|O2|Outcome|Standard-of-Care Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
61507|NCT02198833|O1|Outcome|Micro-Patterned Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
61508|NCT02198833|O2|Outcome|Standard-of-Care Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
61509|NCT02198833|O1|Outcome|Micro-Patterned Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
61510|NCT02198833|O2|Outcome|Standard-of-Care Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
61511|NCT02198833|O1|Outcome|Micro-Patterned Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
61512|NCT02198833|E2|Reported Event|Standard-of-Care Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
61513|NCT02198833|E1|Reported Event|Micro-Patterned Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
61514|NCT02198430|B3|Baseline|Total|Total of all reporting groups
61515|NCT02198430|B2|Baseline|Control Group|Children without hemophilia
61516|NCT02198430|B1|Baseline|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
61517|NCT02198430|P2|Participant Flow|Control Group|Children without hemophilia
61518|NCT02198430|P1|Participant Flow|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
61519|NCT02198430|O2|Outcome|Control Group|Children without hemophilia
61520|NCT02198430|O1|Outcome|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
61521|NCT02198430|O2|Outcome|Control Group|Children without hemophilia
61522|NCT02198430|O1|Outcome|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
61523|NCT02198430|O2|Outcome|Control Group|Children without hemophilia
61531|NCT02198235|B2|Baseline|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
61532|NCT02198235|B1|Baseline|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)~Dexamethasone"
61533|NCT02198235|P3|Participant Flow|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
61534|NCT02198235|P2|Participant Flow|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
61535|NCT02198235|P1|Participant Flow|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)~Dexamethasone"
61536|NCT02198235|O3|Outcome|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
61537|NCT02198235|O2|Outcome|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
61538|NCT02198235|O1|Outcome|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)~Dexamethasone"
61539|NCT02198235|O3|Outcome|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
61540|NCT02198235|O2|Outcome|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
61541|NCT02198235|O1|Outcome|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)~Dexamethasone"
61542|NCT02198235|O3|Outcome|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
61543|NCT02198235|O2|Outcome|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
61544|NCT02198235|O1|Outcome|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)~Dexamethasone"
61545|NCT02198235|O3|Outcome|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
61546|NCT02198235|O2|Outcome|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
61547|NCT02198235|O1|Outcome|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)~Dexamethasone"
61548|NCT02198235|E3|Reported Event|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
61549|NCT02198235|E2|Reported Event|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
61550|NCT02198235|E1|Reported Event|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)~Dexamethasone"
61551|NCT02198040|B4|Baseline|Total|Total of all reporting groups
61552|NCT02198040|B3|Baseline|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
61553|NCT02198040|B2|Baseline|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.~Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.~- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
61554|NCT02198040|B1|Baseline|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each.~Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.~15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.~15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.~15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb, from the abduction, flexion and external rotation of shoulder with extension of elbow and dorsal flexion of wrist, to adduction, internal rotation of shoulder with flexion of elbow and palmar flexion of wrist and fingers.~10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
61555|NCT02198040|P3|Participant Flow|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
61556|NCT02198040|P2|Participant Flow|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.~Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.~- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
61557|NCT02198040|P1|Participant Flow|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.~15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.~15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.~15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb, from the abduction, flexion and external rotation of shoulder with extension of elbow and dorsal flexion of wrist, to adduction, internal rotation of shoulder with flexion of elbow and palmar flexion of wrist and fingers.~10"
61862|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61558|NCT02198040|O3|Outcome|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
61559|NCT02198040|O2|Outcome|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation~Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.~15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.~15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.~15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.~10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
61560|NCT02198040|O1|Outcome|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.~Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.~- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
61561|NCT02198040|O3|Outcome|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
61562|NCT02198040|O2|Outcome|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation~Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.~15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.~15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.~15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.~10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
61563|NCT02198040|O1|Outcome|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.~Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.~- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
61564|NCT02198040|O3|Outcome|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
61565|NCT02198040|O2|Outcome|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.~Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.~- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
61566|NCT02198040|O1|Outcome|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation~Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.~15 minutes. Joint traction of elbow. Joint traction in I-II degree of flexion and extension submaximal of elbow.~15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.~15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb, from the abduction, flexion and external rotation of shoulder with extension of elbow and dorsal flexion of wrist.~10"
61567|NCT02198040|O3|Outcome|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
61568|NCT02198040|O2|Outcome|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation~Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.~15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.~15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.~15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.~10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
61604|NCT02197481|O2|Outcome|BiClamp Forceps Hepatectomy|"The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.~BiClamp forceps: liver transection during hepatectomy by BiClamp forceps"
61605|NCT02197481|O1|Outcome|Clamp-Crushing Technique|"liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted~Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps"
61569|NCT02198040|O1|Outcome|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.~Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.~- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
61570|NCT02198040|O3|Outcome|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
61571|NCT02198040|O2|Outcome|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation~Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.~15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.~15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.~15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.~10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
61572|NCT02198040|O1|Outcome|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.~Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.~- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
61573|NCT02198040|O3|Outcome|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
61574|NCT02198040|O2|Outcome|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation~Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.~15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.~15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.~15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.~10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
61575|NCT02198040|O1|Outcome|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.~Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.~- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
61576|NCT02198040|O3|Outcome|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
61577|NCT02198040|O2|Outcome|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation~Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.~15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.~15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.~15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.~10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
61578|NCT02198040|O1|Outcome|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.~Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.~- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
61579|NCT02198040|E3|Reported Event|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
61606|NCT02197481|O2|Outcome|BiClamp Forceps Hepatectomy|"The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.~BiClamp forceps: liver transection during hepatectomy by BiClamp forceps"
61863|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
61864|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
63774|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
61580|NCT02198040|E2|Reported Event|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation~Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.~15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.~15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.~15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.~10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
61581|NCT02198040|E1|Reported Event|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.~Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.~- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
61582|NCT02197806|B5|Baseline|Total|Total of all reporting groups
61583|NCT02197806|B4|Baseline|AGN-199201 + AGN-190584 in Both Eyes|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
61584|NCT02197806|B3|Baseline|AGN-199201 + AGN-190584 in One Eye|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
61585|NCT02197806|B2|Baseline|AGN-190584|1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
61586|NCT02197806|B1|Baseline|AGN-199201|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
61587|NCT02197806|P4|Participant Flow|AGN-199201 + AGN-190584 in Both Eyes|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
61588|NCT02197806|P3|Participant Flow|AGN-199201 + AGN-190584 in One Eye|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
61589|NCT02197806|P2|Participant Flow|AGN-190584|1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
61590|NCT02197806|P1|Participant Flow|AGN-199201|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
61591|NCT02197806|O4|Outcome|AGN-199201 + AGN-190584 in Both Eyes|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
61592|NCT02197806|O3|Outcome|AGN-199201 + AGN-190584 in One Eye|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
61593|NCT02197806|O2|Outcome|AGN-190584|1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
61594|NCT02197806|O1|Outcome|AGN-199201|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
61595|NCT02197806|E4|Reported Event|AGN-199201 + AGN-190584 in Both Eyes|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
61596|NCT02197806|E3|Reported Event|AGN-199201 + AGN-190584 in One Eye|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
61597|NCT02197806|E2|Reported Event|AGN-190584|1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
61598|NCT02197806|E1|Reported Event|AGN-199201|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
61599|NCT02197481|B3|Baseline|Total|Total of all reporting groups
61600|NCT02197481|B2|Baseline|BiClamp Forceps Hepatectomy|"The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.~BiClamp forceps: liver transection during hepatectomy by BiClamp forceps"
61601|NCT02197481|B1|Baseline|Clamp-Crushing Technique|"liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted~Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps"
61602|NCT02197481|P2|Participant Flow|BiClamp Forceps Hepatectomy|"The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.~BiClamp forceps: liver transection during hepatectomy by BiClamp forceps"
61603|NCT02197481|P1|Participant Flow|Clamp-Crushing Technique|"liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted~Clamp-Crushing technique: Liver transection during hepatectomy by monopole electric knife and blood vessel forceps, but without BiClamp forceps"
61865|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61607|NCT02197481|O1|Outcome|Clamp-Crushing Technique|"liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted~Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps"
61608|NCT02197481|O2|Outcome|BiClamp Forceps Hepatectomy|"The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.~BiClamp forceps: liver transection during hepatectomy by BiClamp forceps"
61609|NCT02197481|O1|Outcome|Clamp-Crushing Technique|"liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted~Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps"
61610|NCT02197481|O2|Outcome|BiClamp Forceps Hepatectomy|"The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.~BiClamp forceps: liver transection during hepatectomy by BiClamp forceps"
61611|NCT02197481|O1|Outcome|Clamp-Crushing Technique|"liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted~Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps"
61612|NCT02197481|O2|Outcome|BiClamp Forceps Hepatectomy|"The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.~BiClamp forceps: liver transection during hepatectomy by BiClamp forceps"
61613|NCT02197481|O1|Outcome|Clamp-Crushing Technique|"liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted~Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps"
61614|NCT02197481|O2|Outcome|BiClamp Forceps Hepatectomy|"The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.~BiClamp forceps: liver transection during hepatectomy by BiClamp forceps"
61615|NCT02197481|O1|Outcome|Clamp-Crushing Technique|"liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted~Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps"
61616|NCT02197481|O2|Outcome|BiClamp Forceps Hepatectomy|"The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.~BiClamp forceps: liver transection during hepatectomy by BiClamp forceps"
61617|NCT02197481|O1|Outcome|Clamp-Crushing Technique|"liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted~Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps"
61618|NCT02197481|O2|Outcome|BiClamp Forceps Hepatectomy|"The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.~BiClamp forceps: liver transection during hepatectomy by BiClamp forceps"
61619|NCT02197481|O1|Outcome|Clamp-Crushing Technique|"liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted~Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps"
61620|NCT02197481|E2|Reported Event|BiClamp Forceps Hepatectomy|"The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.~BiClamp forceps: liver transection during hepatectomy by BiClamp forceps"
61621|NCT02197481|E1|Reported Event|Clamp-Crushing Technique|"liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted~Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps"
61622|NCT02197455|B1|Baseline|Tofacitinib Administration|"5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.~Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months."
61623|NCT02197455|P1|Participant Flow|Tofacitinib Administration|"5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.~Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months."
61624|NCT02197455|O1|Outcome|Tofacitinib Administration|"5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.~Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months."
61625|NCT02197455|O1|Outcome|Tofacitinib Administration|"5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.~Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months."
61626|NCT02197455|E1|Reported Event|Tofacitinib Administration|"5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.~Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months."
61627|NCT02197273|B3|Baseline|Total|Total of all reporting groups
61628|NCT02197273|B2|Baseline|Liposomal Bupivacaine|"THA:~Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue~TKA:~Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue~TSA:~All patients will receive a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.~Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle~Liposomal bupivacaine~Standard of care analgesia"
61658|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
61659|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
61629|NCT02197273|B1|Baseline|Standard of Care Analgesia|"THA:~All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine~Injection into capsular tissue after placement of the acetabular component:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TKA:~All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine All patients will receive an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc~Injection into posterior capsule of the knee:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TSA:~All patients will receive a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.~Standard of care analgesia"
61630|NCT02197273|P2|Participant Flow|Liposomal Bupivacaine|"THA:~36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue~TKA:~34 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue~TSA:~34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.~Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle~Liposomal bupivacaine~Standard of care analgesia"
61631|NCT02197273|P1|Participant Flow|Standard of Care Analgesia|"THA:~33 patients received a spinal anesthetic using Fentanyl and Bupivacaine~Injection into capsular tissue after placement of the acetabular component:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TKA:~39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc~Injection into posterior capsule of the knee:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TSA:~35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.~Standard of care analgesia"
61632|NCT02197273|O2|Outcome|Liposomal Bupivacaine|"THA:~36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue~TKA:~34 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue~TSA:~34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.~Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle~Liposomal bupivacaine~Standard of care analgesia"
61633|NCT02197273|O1|Outcome|Standard of Care Analgesia|"THA:~33 patients received a spinal anesthetic using Fentanyl and Bupivacaine~Injection into capsular tissue after placement of the acetabular component:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TKA:~39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc~Injection into posterior capsule of the knee:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TSA:~35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.~Standard of care analgesia"
61634|NCT02197273|O2|Outcome|Liposomal Bupivacaine|"THA:~36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue~TKA:~34 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue~TSA:~34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.~Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle~Liposomal bupivacaine~Standard of care analgesia"
61635|NCT02197273|O1|Outcome|Standard of Care Analgesia|"THA:~33 patients received a spinal anesthetic using Fentanyl and Bupivacaine~Injection into capsular tissue after placement of the acetabular component:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TKA:~39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc~Injection into posterior capsule of the knee:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TSA:~35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.~Standard of care analgesia"
61636|NCT02197273|O2|Outcome|Liposomal Bupivacaine|"THA:~36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue~TKA:~34 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue~TSA:~34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.~Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle~Liposomal bupivacaine~Standard of care analgesia"
61637|NCT02197273|O1|Outcome|Standard of Care Analgesia|"THA:~33 patients received a spinal anesthetic using Fentanyl and Bupivacaine~Injection into capsular tissue after placement of the acetabular component:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TKA:~39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc~Injection into posterior capsule of the knee:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TSA:~35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.~Standard of care analgesia"
61638|NCT02197273|E2|Reported Event|Liposomal Bupivacaine|"THA:~36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue~TKA:~33 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue~TSA:~34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.~Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle~Liposomal bupivacaine~Standard of care analgesia"
61866|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61867|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61639|NCT02197273|E1|Reported Event|Standard of Care Analgesia|"THA:~33 patients received a spinal anesthetic using Fentanyl and Bupivacaine~Injection into capsular tissue after placement of the acetabular component:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TKA:~39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc~Injection into posterior capsule of the knee:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TSA:~35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.~Standard of care analgesia"
61640|NCT02197247|B1|Baseline|AZD9291 and Rifampicin (Part A); AZD9291 Alone (Part B)|"In Part A of the study, sequential treatments of AZD9291 alone, followed by AZD9291 + rifampicin, followed by AZD9291 alone. Each patient received 80 mg oral doses of AZD9291 tablets once daily for 77 days (Days 1 to 77) and additionally received 600 mg oral doses of rifampicin once daily on Days 29 to 49.~In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation."
61641|NCT02197247|P1|Participant Flow|AZD9291 and Rifampicin (Part A); AZD9291 Alone (Part B)|"In Part A of the study, sequential treatments of AZD9291 alone, followed by AZD9291 + rifampicin, followed by AZD9291 alone. Each patient received 80 mg oral doses of AZD9291 tablets once daily for 77 days (Days 1 to 77) and additionally received 600 mg oral doses of rifampicin once daily on Days 29 to 49.~In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation."
61642|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
61643|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
61644|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
61645|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
61646|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
61647|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
61648|NCT02197247|O1|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
61649|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
61650|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
61651|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
61652|NCT02197247|O1|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
61653|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
61654|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
61655|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
61656|NCT02197247|O1|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
61657|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
61868|NCT02196714|O4|Outcome|GP MDI 14.4 ug|GP MDI 14.4 ug
61660|NCT02197247|O1|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
61661|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
61662|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
61663|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
61664|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
61665|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
61666|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
61667|NCT02197247|O2|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
61668|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
61669|NCT02197247|O1|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
61670|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
61671|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
61672|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
61673|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
61674|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
61675|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
61676|NCT02197247|O2|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
61677|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
61678|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
61679|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
61680|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
61869|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
61870|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61681|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
61682|NCT02197247|E3|Reported Event|Part B|In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation.
61683|NCT02197247|E2|Reported Event|Part A|In Part A of the study, each patient received 80 mg oral doses of AZD9291 tablets once daily for 77 days (Days 1 to 77) and additionally received 600 mg oral doses of rifampicin once daily on Days 29 to 49.
61684|NCT02197247|E1|Reported Event|Overall|Parts A and B of the study combined.
61685|NCT02197234|B1|Baseline|Simvastatin and AZD9291 (Part A); AZD9291 Alone (Part B)|"In Part A of the study, sequential treatments of simvastatin alone followed by AZD9291 alone, followed by simvastatin + AZD9291. Each patient received 80 mg oral doses of AZD9291 tablets once daily for 30 days (Days 3 to 32) and single 40 mg oral doses of simvastatin on Day 1 and Day 31.~In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation."
61686|NCT02197234|P1|Participant Flow|Simvastatin and AZD9291 (Part A); AZD9291 Alone (Part B)|"In Part A of the study, sequential treatments of simvastatin alone followed by AZD9291 alone, followed by simvastatin + AZD9291. Each patient received 80 mg oral doses of AZD9291 tablets once daily for 30 days (Days 3 to 32) and single 40 mg oral doses of simvastatin on Day 1 and Day 31.~In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation."
61687|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
61688|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
61689|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
61690|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
61691|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
61692|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
61693|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
61694|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
61695|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
61696|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
61697|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
61698|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
61699|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
61700|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
61701|NCT02197234|E3|Reported Event|Part B Safety Population|In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation.
61702|NCT02197234|E2|Reported Event|Part A Safety Population|In Part A of the study, each patient received 80 mg oral doses of AZD9291 tablets once daily for 30 days (Days 3 to 32) and single 40 mg oral doses of simvastatin on Day 1 and Day 31.
61703|NCT02197234|E1|Reported Event|Overall Safety Population|Parts A and B of the study combined.
61704|NCT02197130|B4|Baseline|Total|Total of all reporting groups
61705|NCT02197130|B3|Baseline|PF-02545920 20 mg BID|The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61706|NCT02197130|B2|Baseline|Placebo|Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61707|NCT02197130|B1|Baseline|PF-02545920 5 mg BID|Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61708|NCT02197130|P3|Participant Flow|PF-02545920 20 mg BID|The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61709|NCT02197130|P2|Participant Flow|Placebo|Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61710|NCT02197130|P1|Participant Flow|PF-02545920 5 mg BID|Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61871|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61711|NCT02197130|O3|Outcome|Placebo|Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61712|NCT02197130|O2|Outcome|PF-02545920 5 mg BID|Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61713|NCT02197130|O1|Outcome|PF-02545920 20 mg BID|The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61714|NCT02197130|O3|Outcome|Placebo|Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61715|NCT02197130|O2|Outcome|PF-02545920 5 mg BID|Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61716|NCT02197130|O1|Outcome|PF-02545920 20 mg BID|The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61717|NCT02197130|O3|Outcome|Placebo|Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61718|NCT02197130|O2|Outcome|PF-02545920 5 mg BID|Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61719|NCT02197130|O1|Outcome|PF-02545920 20 mg BID|The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61720|NCT02197130|O3|Outcome|Placebo|Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61721|NCT02197130|O2|Outcome|PF-02545920 5 mg BID|Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61722|NCT02197130|O1|Outcome|PF-02545920 20 mg BID|The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61723|NCT02197130|O3|Outcome|Placebo|Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61724|NCT02197130|O2|Outcome|PF-02545920 5 mg BID|Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61725|NCT02197130|O1|Outcome|PF-02545920 20 mg BID|The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61726|NCT02197130|O3|Outcome|Placebo|Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61727|NCT02197130|O2|Outcome|PF-02545920 5 mg BID|Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61728|NCT02197130|O1|Outcome|PF-02545920 20 mg BID|The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61729|NCT02197130|O3|Outcome|Placebo|Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61730|NCT02197130|O2|Outcome|PF-02545920 5 mg BID|Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61731|NCT02197130|O1|Outcome|PF-02545920 20 mg BID|The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61732|NCT02197130|O3|Outcome|Placebo|Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61733|NCT02197130|O2|Outcome|PF-02545920 5 mg BID|Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61734|NCT02197130|O1|Outcome|PF-02545920 20 mg BID|The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61735|NCT02197130|O3|Outcome|Placebo|Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61736|NCT02197130|O2|Outcome|PF-02545920 5 mg BID|Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61737|NCT02197130|O1|Outcome|PF-02545920 20 mg BID|The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61738|NCT02197130|O3|Outcome|Placebo|Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61739|NCT02197130|O2|Outcome|PF-02545920 5 mg BID|Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61740|NCT02197130|O1|Outcome|PF-02545920 20 mg BID|The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61741|NCT02197130|O3|Outcome|Placebo|Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61872|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61873|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61874|NCT02196714|O4|Outcome|GP MDI 14.4 µg|GP MDI 14.4 µg
61742|NCT02197130|O2|Outcome|PF-02545920 5 mg BID|Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61743|NCT02197130|O1|Outcome|PF-02545920 20 mg BID|The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61744|NCT02197130|O3|Outcome|Placebo|Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61745|NCT02197130|O2|Outcome|PF-02545920 5 mg BID|Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61746|NCT02197130|O1|Outcome|PF-02545920 20 mg BID|The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61747|NCT02197130|O3|Outcome|Placebo|Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61748|NCT02197130|O2|Outcome|PF-02545920 5 mg BID|Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61749|NCT02197130|O1|Outcome|PF-02545920 20 mg BID|The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61750|NCT02197130|O3|Outcome|Placebo|Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61751|NCT02197130|O2|Outcome|PF-02545920 5 mg BID|Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61752|NCT02197130|O1|Outcome|PF-02545920 20 mg BID|The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61753|NCT02197130|O3|Outcome|Placebo|Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61754|NCT02197130|O2|Outcome|PF-02545920 5 mg BID|Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61755|NCT02197130|O1|Outcome|PF-02545920 20 mg BID|The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61779|NCT02196922|O1|Outcome|Comprehensive Outpatient Management (COM)|"Patients in the COM group will receive outpatient management at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicaid, Medicare or sliding scale/uncompensated care). COM patients will be contacted on a weekly basis in order to maintain comparable frequency of contact.~Patients receiving COM experience typical chronic care management received by disparity patients at a heart failure clinic."
61875|NCT02196714|O3|Outcome|GP MDI 28.8 µg|GP MDI 28.8 µg
61876|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61756|NCT02197130|E3|Reported Event|PF-02545920 20 mg BID|The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61757|NCT02197130|E2|Reported Event|Placebo|Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61758|NCT02197130|E1|Reported Event|PF-02545920 5 mg BID|Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
61759|NCT02197065|B3|Baseline|Total|Total of all reporting groups
61760|NCT02197065|B2|Baseline|Sugar Pill|"Sugar pill (placebo) daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.~Placebo"
61761|NCT02197065|B1|Baseline|Atorvastatin|"Atorvastatin 40mg daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.~Atorvastatin: Atorvastatin or placebo will be started at least 4 hours prior to surgery, and continued nightly until postoperative day 45"
61762|NCT02197065|P2|Participant Flow|Sugar Pill|"Sugar pill (placebo) daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.~Placebo"
61763|NCT02197065|P1|Participant Flow|Atorvastatin|"Atorvastatin 40mg daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.~Atorvastatin: Atorvastatin or placebo will be started at least 4 hours prior to surgery, and continued nightly until postoperative day 45"
61764|NCT02197065|O2|Outcome|Sugar Pill|Sugar pill (placebo) daily starting 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
61765|NCT02197065|O1|Outcome|Atorvastatin|Atorvastatin 40mg daily starting 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
61766|NCT02197065|O2|Outcome|Sugar Pill|"Sugar pill (placebo) daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.~Placebo"
61767|NCT02197065|O1|Outcome|Atorvastatin|"Atorvastatin 40mg daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.~Atorvastatin: Atorvastatin or placebo will be started at least 4 hours prior to surgery, and continued nightly until postoperative day 45"
61768|NCT02197065|O1|Outcome|All Patients|All patients in the study
61769|NCT02197065|E2|Reported Event|Sugar Pill|"Sugar pill (placebo) daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.~Placebo"
61770|NCT02197065|E1|Reported Event|Atorvastatin|"Atorvastatin 40mg daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.~Atorvastatin: Atorvastatin or placebo will be started at least 4 hours prior to surgery, and continued nightly until postoperative day 45"
61771|NCT02196922|B3|Baseline|Total|Total of all reporting groups
61772|NCT02196922|B2|Baseline|Telehealth Self Management (TSM)|Telehealth Self Management (TSM): Experimental is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence to the provider station.
61773|NCT02196922|B1|Baseline|Comprehensive Outpatient Management (COM)|"Patients in the control group will receive COM at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicaid, Medicare or sliding scale/uncompensated care). COM patients will be contacted on a weekly basis in order to maintain comparable frequency of contact.~COM: COM experience typical chronic care management received by disparity patients I a heart failure clinic."
61774|NCT02196922|P2|Participant Flow|Telehealth Self Management (TSM)|Telehealth Self Management (TSM): Experimental: TSM is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence to the provider station.
61775|NCT02196922|P1|Participant Flow|Comprehensive Outpatient Management (COM-Standard of Care)|"Patients in the control group will receive comprehensive outpatient management (COM)at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicaid, Medicare or sliding scale/uncompensated care). COM patients will be contacted on a weekly basis in order to maintain comparable frequency of contact.~COM: Patients receiving COM experience chronic care management received by disparity patients at a heart failure clinic."
61776|NCT02196922|O2|Outcome|Telehealth Self Management (TSM)|Telehealth Self Management (TSM): Experimental: is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence, to the provider station.
61777|NCT02196922|O1|Outcome|Comprehensive Outpatient Management (COM)|"Patients in the COM group will receive outpatient management at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicaid, Medicare or sliding scale/uncompensated care). COM patients will be contacted on a weekly basis in order to maintain comparable frequency of contact.~Patients receiving COM experience typical chronic care management received by disparity patients at a heart failure clinic."
61778|NCT02196922|O2|Outcome|Telehealth Self Management (TSM)|Telehealth Self Management (TSM): Experimental: is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence, to the provider station.
61780|NCT02196922|O2|Outcome|Telehealth Self Management (TSM)|Telehealth Self Management (TSM): Experimental is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence to the provider station.
61781|NCT02196922|O1|Outcome|Comprehensive Outpatient Management (COM)|"Patients in the COM group will receive outpatient care at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicaid, Medicare or sliding scale/uncompensated care). COM patients will be contacted on a weekly basis in order to maintain comparable frequency of contact.~COM: Patients receiving COM experience typical chronic care management received by disparity patients at heart failure clinic."
61782|NCT02196922|E2|Reported Event|Telehealth Self Management (TSM)|Telehealth Self Management (TSM): Experimental: is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence, to the provider station.
61783|NCT02196922|E1|Reported Event|Comprehensive Outpatient Management (COM)|"Patients in the COM group will receive outpatient management at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicaid, Medicare or sliding scale/uncompensated care). COM patients will be contacted on a weekly basis in order to maintain comparable frequency of contact.~Patients receiving COM experience typical chronic care management received by disparity patients at a heart failure clinic."
61784|NCT02196766|B1|Baseline|Bioclean First Care EX / Aosept Clearcare / Comfil|Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
61785|NCT02196766|P2|Participant Flow|Aosept Clearcare Combo First,Then Bioclean First Care EX Combo|Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
61786|NCT02196766|P1|Participant Flow|Bioclean First Care EX Combo, Then Aosept Clearcare Combo|Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
61787|NCT02196766|O2|Outcome|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
61788|NCT02196766|O1|Outcome|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
61789|NCT02196766|O2|Outcome|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
61790|NCT02196766|O1|Outcome|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
61791|NCT02196766|O2|Outcome|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
61792|NCT02196766|O1|Outcome|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
61793|NCT02196766|O2|Outcome|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
61794|NCT02196766|O1|Outcome|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
61795|NCT02196766|O2|Outcome|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
61796|NCT02196766|O1|Outcome|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
61797|NCT02196766|O2|Outcome|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
61798|NCT02196766|O1|Outcome|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
61861|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
63775|NCT02185105|O2|Outcome|Comfilcon A Toric|
61799|NCT02196766|E2|Reported Event|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
61800|NCT02196766|E1|Reported Event|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
61801|NCT02196714|B1|Baseline|All Subjects|Analysis Set: All Subjects Randomized
61802|NCT02196714|P4|Participant Flow|Received GP MDI 14.4 μg|Received GP MDI 14.4 μg
61803|NCT02196714|P3|Participant Flow|Received GP MDI 28.8 μg|Glycopyrronium (GP) Metered Dose Inhaler (MDI) 28.8 μg
61804|NCT02196714|P2|Participant Flow|Received GFF MDI 14.4/9.6 μg|Received GFF MDI 14.4/9.6 μg
61805|NCT02196714|P1|Participant Flow|Received GFF MDI 28.8/9.6 μg|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 μg
61806|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
61807|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61808|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61809|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
61810|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61811|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61812|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
61813|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61814|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61815|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
61816|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61817|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61818|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
61819|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61820|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61821|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
61822|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61823|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61824|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
61825|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61826|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61827|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
61828|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61829|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61830|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
61831|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61832|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61833|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
61834|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61835|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61836|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
61837|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61838|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61839|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
61840|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61841|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61842|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
61843|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61844|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61845|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
61846|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61847|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61848|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
61849|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61850|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61851|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
61852|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61853|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61854|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
61855|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61856|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61857|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
61858|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61859|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61860|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
61877|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61878|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61879|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61880|NCT02196714|O4|Outcome|GP MDI 14.4 µg|GP MDI 14.4 µg
61881|NCT02196714|O3|Outcome|GP MDI 28.8 µg|GP MDI 28.8 µg
61882|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61883|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61884|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61885|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61886|NCT02196714|O4|Outcome|GP MDI 14.4 ug|GP MDI 14.4 ug
61887|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
61888|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61889|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61890|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61891|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61892|NCT02196714|O4|Outcome|GP MDI 14.4 ug|GP MDI 14.4 ug
61893|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
61894|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61895|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61896|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61897|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61898|NCT02196714|O4|Outcome|GP MDI 14.4 µg|GP MDI 14.4 µg
61899|NCT02196714|O3|Outcome|GP MDI 28.8 µg|GP MDI 28.8 µg
61900|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61901|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61902|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61903|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61904|NCT02196714|O4|Outcome|GP MDI 14.4 µg|GP MDI 14.4 µg
61905|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
61906|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61907|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61908|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61909|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61910|NCT02196714|O4|Outcome|GP MDI 14.4 ug|GP MDI 14.4 ug
61911|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
61912|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61913|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61914|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61915|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61916|NCT02196714|O4|Outcome|GP MDI 14.4 µg|GP MDI 14.4 µg
61917|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
61918|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61919|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61920|NCT02196714|E4|Reported Event|GP MDI 14.4 µg|GP MDI 14.4 µg
61921|NCT02196714|E3|Reported Event|GP MDI 28.8 ug|GP MDI 28.8 ug
61922|NCT02196714|E2|Reported Event|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
61923|NCT02196714|E1|Reported Event|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
61924|NCT02196701|B3|Baseline|Total|Total of all reporting groups
61925|NCT02196701|B2|Baseline|Secondary Sub-optimal Responders - ADA + MTX|Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61926|NCT02196701|B1|Baseline|Primary Sub-optimal Responders - ADA + MTX|Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61927|NCT02196701|P1|Participant Flow|Adalimumab + Methotrexate|Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61928|NCT02196701|O3|Outcome|Adalimumab + Methotrexate|Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61929|NCT02196701|O2|Outcome|Secondary Sub-optimal Responders - ADA + MTX|Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61930|NCT02196701|O1|Outcome|Primary Sub-optimal Responders - ADA + MTX|Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61931|NCT02196701|O3|Outcome|Adalimumab + Methotrexate|Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
63776|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
61932|NCT02196701|O2|Outcome|Secondary Sub-optimal Responders - ADA + MTX|Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61933|NCT02196701|O1|Outcome|Primary Sub-optimal Responders - ADA + MTX|Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61934|NCT02196701|O3|Outcome|Adalimumab + Methotrexate|Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61935|NCT02196701|O2|Outcome|Secondary Sub-optimal Responders - ADA + MTX|Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61936|NCT02196701|O1|Outcome|Primary Sub-optimal Responders - ADA + MTX|Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61937|NCT02196701|O3|Outcome|Adalimumab + Methotrexate|Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61938|NCT02196701|O2|Outcome|Secondary Sub-optimal Responders - ADA + MTX|Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61939|NCT02196701|O1|Outcome|Primary Sub-optimal Responders - ADA + MTX|Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61940|NCT02196701|O3|Outcome|Adalimumab + Methotrexate|Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61941|NCT02196701|O2|Outcome|Secondary Sub-optimal Responders - ADA + MTX|Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61942|NCT02196701|O1|Outcome|Primary Sub-optimal Responders - ADA + MTX|Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61943|NCT02196701|O3|Outcome|Adalimumab + Methotrexate|Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61944|NCT02196701|O2|Outcome|Secondary Sub-optimal Responders - ADA + MTX|Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61945|NCT02196701|O1|Outcome|Primary Sub-optimal Responders - ADA + MTX|Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61946|NCT02196701|O3|Outcome|Adalimumab + Methotrexate|Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61947|NCT02196701|O2|Outcome|Secondary Sub-optimal Responders - ADA + MTX|Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61948|NCT02196701|O1|Outcome|Primary Sub-optimal Responders - ADA + MTX|Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61949|NCT02196701|O3|Outcome|Adalimumab + Methotrexate|Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61950|NCT02196701|O2|Outcome|Secondary Sub-optimal Responders - ADA + MTX|Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61951|NCT02196701|O1|Outcome|Primary Sub-optimal Responders - ADA + MTX|Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61952|NCT02196701|O3|Outcome|Adalimumab + Methotrexate|Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61953|NCT02196701|O2|Outcome|Secondary Sub-optimal Responders - ADA + MTX|Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61954|NCT02196701|O1|Outcome|Primary Sub-optimal Responders - ADA + MTX|Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
63777|NCT02185105|O2|Outcome|Comfilcon A Toric|
61955|NCT02196701|O3|Outcome|Adalimumab + Methotrexate|Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61956|NCT02196701|O2|Outcome|Secondary Sub-optimal Responders - ADA + MTX|Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61957|NCT02196701|O1|Outcome|Primary Sub-optimal Responders - ADA + MTX|Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61958|NCT02196701|O3|Outcome|Adalimumab + Methotrexate|Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61959|NCT02196701|O2|Outcome|Secondary Sub-optimal Responders - ADA + MTX|Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61960|NCT02196701|O1|Outcome|Primary Sub-optimal Responders - ADA + MTX|Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61961|NCT02196701|O3|Outcome|Adalimumab + Methotrexate|Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61962|NCT02196701|O2|Outcome|Secondary Sub-optimal Responders - ADA + MTX|Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61963|NCT02196701|O1|Outcome|Primary Sub-optimal Responders - ADA + MTX|Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61964|NCT02196701|O3|Outcome|Adalimumab + Methotrexate|Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61965|NCT02196701|O2|Outcome|Secondary Sub-optimal Responders - ADA + MTX|Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61966|NCT02196701|O1|Outcome|Primary Sub-optimal Responders - ADA + MTX|Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61967|NCT02196701|O1|Outcome|Adalimumab + Methotrexate|Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61968|NCT02196701|O1|Outcome|Adalimumab + Methotrexate|Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61969|NCT02196701|O3|Outcome|Adalimumab + Methotrexate|Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61970|NCT02196701|O2|Outcome|Secondary Sub-optimal Responders - ADA + MTX|Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61971|NCT02196701|O1|Outcome|Primary Sub-optimal Responders - ADA + MTX|Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61972|NCT02196701|O3|Outcome|Adalimumab + Methotrexate|Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61973|NCT02196701|O2|Outcome|Secondary Sub-optimal Responders - ADA + MTX|Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61974|NCT02196701|O1|Outcome|Primary Sub-optimal Responders - ADA + MTX|Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61975|NCT02196701|O3|Outcome|Adalimumab + Methotrexate|Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61976|NCT02196701|O2|Outcome|Secondary Sub-optimal Responders - ADA + MTX|Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61977|NCT02196701|O1|Outcome|Primary Sub-optimal Responders - ADA + MTX|Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61978|NCT02196701|O3|Outcome|Adalimumab + Methotrexate|Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
62140|NCT02195687|B2|Baseline|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
61979|NCT02196701|O2|Outcome|Secondary Sub-optimal Responders - ADA + MTX|Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61980|NCT02196701|O1|Outcome|Primary Sub-optimal Responders - ADA + MTX|Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61981|NCT02196701|E1|Reported Event|Adalimumab + Methotrexate|Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
61982|NCT02196675|B4|Baseline|Total|Total of all reporting groups
61983|NCT02196675|B3|Baseline|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler
61984|NCT02196675|B2|Baseline|Lobectomy|Subjects undergoing VATS lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler
61985|NCT02196675|B1|Baseline|Wedge Resection|Subjects undergoing VATS wedge resection using Echelon FlexTM Powered ENDOPATH® Stapler
61986|NCT02196675|P3|Participant Flow|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler
61987|NCT02196675|P2|Participant Flow|Lobectomy|Subjects undergoing VATS lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler
61988|NCT02196675|P1|Participant Flow|Wedge Resection|Subjects undergoing VATS wedge resection using Echelon FlexTM Powered ENDOPATH® Stapler
61989|NCT02196675|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
61990|NCT02196675|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
61991|NCT02196675|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
61992|NCT02196675|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
61993|NCT02196675|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
61994|NCT02196675|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
61995|NCT02196675|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
61996|NCT02196675|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
61997|NCT02196675|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
61998|NCT02196675|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
61999|NCT02196675|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
62000|NCT02196675|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
62001|NCT02196675|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
62002|NCT02196675|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
62003|NCT02196675|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
62004|NCT02196675|E3|Reported Event|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
62005|NCT02196675|E2|Reported Event|Lobectomy|Subjects undergoing VATS lobectomy
62006|NCT02196675|E1|Reported Event|Wedge Resection|Subjects undergoing VATS wedge resection
62007|NCT02196259|B4|Baseline|Total|Total of all reporting groups
62008|NCT02196259|B3|Baseline|Depression|The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
62009|NCT02196259|B2|Baseline|Initial Hospital|The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
62010|NCT02196259|B1|Baseline|Initial MRI|"The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)~Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)"
62011|NCT02196259|P3|Participant Flow|Depresssion|
62012|NCT02196259|P2|Participant Flow|Hospital|
62013|NCT02196259|P1|Participant Flow|Initial MRI|"The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)~Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)"
62014|NCT02196259|O2|Outcome|Depression|"The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)~Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)"
62015|NCT02196259|O1|Outcome|Initial MRI|The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
62016|NCT02196259|E3|Reported Event|Depression|"The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)~Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)"
62017|NCT02196259|E2|Reported Event|Hospital|"The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)~Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)"
62018|NCT02196259|E1|Reported Event|Initial fMRI|"The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)~Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)"
62019|NCT02196168|B3|Baseline|Total|Total of all reporting groups
62020|NCT02196168|B2|Baseline|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
62021|NCT02196168|B1|Baseline|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~WEE1 Inhibitor AZD1775: Given PO"
62022|NCT02196168|P2|Participant Flow|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
62023|NCT02196168|P1|Participant Flow|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~WEE1 Inhibitor AZD1775: Given PO"
62024|NCT02196168|O2|Outcome|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
62025|NCT02196168|O1|Outcome|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~WEE1 Inhibitor AZD1775: Given PO"
62026|NCT02196168|O2|Outcome|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
62027|NCT02196168|O1|Outcome|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~WEE1 Inhibitor AZD1775: Given PO"
62028|NCT02196168|O2|Outcome|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
62029|NCT02196168|O1|Outcome|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~WEE1 Inhibitor AZD1775: Given PO"
62030|NCT02196168|O2|Outcome|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
62031|NCT02196168|O1|Outcome|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~WEE1 Inhibitor AZD1775: Given PO"
62032|NCT02196168|O2|Outcome|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
62033|NCT02196168|O1|Outcome|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~WEE1 Inhibitor AZD1775: Given PO"
62034|NCT02196168|O2|Outcome|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
62035|NCT02196168|O1|Outcome|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~WEE1 Inhibitor AZD1775: Given PO"
62036|NCT02196168|O2|Outcome|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
62037|NCT02196168|O1|Outcome|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~WEE1 Inhibitor AZD1775: Given PO"
62038|NCT02196168|E2|Reported Event|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
62141|NCT02195687|B1|Baseline|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
62039|NCT02196168|E1|Reported Event|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~WEE1 Inhibitor AZD1775: Given PO"
62040|NCT02196077|B1|Baseline|Subjects|
62041|NCT02196077|P1|Participant Flow|Subjects|
62042|NCT02196077|O5|Outcome|FF MDI 9.6 ug|FF MDI 9.6 ug
62043|NCT02196077|O4|Outcome|BD MDI 320 ug|BD MDI 320 ug
62044|NCT02196077|O3|Outcome|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
62045|NCT02196077|O2|Outcome|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
62046|NCT02196077|O1|Outcome|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
62047|NCT02196077|O5|Outcome|FF MDI 9.6 ug|FF MDI 9.6 ug
62048|NCT02196077|O4|Outcome|BD MDI 320 ug|BD MDI 320 ug
62049|NCT02196077|O3|Outcome|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
62050|NCT02196077|O2|Outcome|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
62051|NCT02196077|O1|Outcome|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
62052|NCT02196077|O5|Outcome|FF MDI 9.6 ug|FF MDI 9.6 ug
62053|NCT02196077|O4|Outcome|BD MDI 320 ug|BD MDI 320 ug
62054|NCT02196077|O3|Outcome|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
62055|NCT02196077|O2|Outcome|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
62056|NCT02196077|O1|Outcome|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
62057|NCT02196077|O5|Outcome|FF MDI 9.6 ug|FF MDI 9.6 ug
62058|NCT02196077|O4|Outcome|BD MDI 320 ug|BD MDI 320 ug
62059|NCT02196077|O3|Outcome|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
62060|NCT02196077|O2|Outcome|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
62061|NCT02196077|O1|Outcome|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
62062|NCT02196077|O5|Outcome|FF MDI 9.6 ug|FF MDI 9.6 ug
62063|NCT02196077|O4|Outcome|BD MDI 320 ug|BD MDI 320 ug
62064|NCT02196077|O3|Outcome|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
62065|NCT02196077|O2|Outcome|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
62066|NCT02196077|O1|Outcome|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
62067|NCT02196077|O5|Outcome|FF MDI 9.6 ug|FF MDI 9.6 ug
62068|NCT02196077|O4|Outcome|BD MDI 320 ug|BD MDI 320 ug
62069|NCT02196077|O3|Outcome|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
62070|NCT02196077|O2|Outcome|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
62071|NCT02196077|O1|Outcome|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
62072|NCT02196077|O5|Outcome|FF MDI 9.6 ug|FF MDI 9.6 ug
62073|NCT02196077|O4|Outcome|BD MDI 320 ug|BD MDI 320 ug
62074|NCT02196077|O3|Outcome|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
62075|NCT02196077|O2|Outcome|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
62076|NCT02196077|O1|Outcome|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
62077|NCT02196077|O5|Outcome|FF MDI 9.6 ug|FF MDI 9.6 ug
62078|NCT02196077|O4|Outcome|BD MDI 320 ug|BD MDI 320 ug
62079|NCT02196077|O3|Outcome|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
62080|NCT02196077|O2|Outcome|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
62081|NCT02196077|O1|Outcome|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
62082|NCT02196077|E5|Reported Event|FF MDI 9.6 ug|FF MDI 9.6 ug
62083|NCT02196077|E4|Reported Event|BD MDI 320 ug|BD MDI 320 ug
62084|NCT02196077|E3|Reported Event|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
62085|NCT02196077|E2|Reported Event|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
62086|NCT02196077|E1|Reported Event|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
62087|NCT02195986|B4|Baseline|Total|Total of all reporting groups
62088|NCT02195986|B3|Baseline|Placebo Vaginal Cream|"Placebo Vaginal Cream, administered once daily for 7 days.~Placebo Vaginal Cream: Placebo Vaginal Cream (1 x 2 g for 7 days)"
62089|NCT02195986|B2|Baseline|Estrace® 0.01% Cream|"Estrace® 0.01% vaginal cream, administered once daily for 7 days.~Estrace® 0.01% cream: Estrace® 0.01% vaginal cream (1 x 2 g for 7 days)"
62090|NCT02195986|B1|Baseline|Estradiol Vaginal Cream|"Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days.~Estradiol Vaginal Cream, 0.01%: Estradiol Vaginal Cream, 0.01% (1 x 2 g for 7 days)"
62091|NCT02195986|P3|Participant Flow|Placebo Vaginal Cream|"Placebo Vaginal Cream, administered once daily for 7 days.~Placebo Vaginal Cream: Placebo Vaginal Cream (1 x 2 g for 7 days)"
62092|NCT02195986|P2|Participant Flow|Estrace® 0.01% Cream|"Estrace® 0.01% vaginal cream, administered once daily for 7 days.~Estrace® 0.01% cream: Estrace® 0.01% vaginal cream (1 x 2 g for 7 days)"
62093|NCT02195986|P1|Participant Flow|Estradiol Vaginal Cream|"Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days.~Estradiol Vaginal Cream, 0.01%: Estradiol Vaginal Cream, 0.01% (1 x 2 g for 7 days)"
62094|NCT02195986|O3|Outcome|Placebo Vaginal Cream|"Placebo Vaginal Cream, administered once daily for 7 days.~Placebo Vaginal Cream: Placebo Vaginal Cream (1 x 2 g for 7 days)"
62095|NCT02195986|O2|Outcome|Estrace® 0.01% Cream|"Estrace® 0.01% vaginal cream, administered once daily for 7 days.~Estrace® 0.01% cream: Estrace® 0.01% vaginal cream (1 x 2 g for 7 days)"
62096|NCT02195986|O1|Outcome|Estradiol Vaginal Cream|"Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days.~Estradiol Vaginal Cream, 0.01%: Estradiol Vaginal Cream, 0.01% (1 x 2 g for 7 days)"
62097|NCT02195986|O2|Outcome|Estrace® 0.01% Cream|"Estrace® 0.01% vaginal cream, administered once daily for 7 days.~Estrace® 0.01% cream: Estrace® 0.01% vaginal cream (1 x 2 g for 7 days)"
62098|NCT02195986|O1|Outcome|Estradiol Vaginal Cream|"Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days.~Estradiol Vaginal Cream, 0.01%: Estradiol Vaginal Cream, 0.01% (1 x 2 g for 7 days)"
62099|NCT02195986|O3|Outcome|Placebo Vaginal Cream|"Placebo Vaginal Cream, administered once daily for 7 days.~Placebo Vaginal Cream: Placebo Vaginal Cream (1 x 2 g for 7 days)"
62100|NCT02195986|O2|Outcome|Estrace® 0.01% Cream|"Estrace® 0.01% vaginal cream, administered once daily for 7 days.~Estrace® 0.01% cream: Estrace® 0.01% vaginal cream (1 x 2 g for 7 days)"
62101|NCT02195986|O1|Outcome|Estradiol Vaginal Cream|"Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days.~Estradiol Vaginal Cream, 0.01%: Estradiol Vaginal Cream, 0.01% (1 x 2 g for 7 days)"
62102|NCT02195986|O2|Outcome|Estrace® 0.01% Cream|"Estrace® 0.01% vaginal cream, administered once daily for 7 days.~Estrace® 0.01% cream: Estrace® 0.01% vaginal cream (1 x 2 g for 7 days)"
62103|NCT02195986|O1|Outcome|Estradiol Vaginal Cream|"Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days.~Estradiol Vaginal Cream, 0.01%: Estradiol Vaginal Cream, 0.01% (1 x 2 g for 7 days)"
62104|NCT02195986|E3|Reported Event|Placebo Vaginal Cream|"Placebo Vaginal Cream, administered once daily for 7 days.~Placebo Vaginal Cream: Placebo Vaginal Cream (1 x 2 g for 7 days)"
62105|NCT02195986|E2|Reported Event|Estrace® 0.01% Cream|"Estrace® 0.01% vaginal cream, administered once daily for 7 days.~Estrace® 0.01% cream: Estrace® 0.01% vaginal cream (1 x 2 g for 7 days)"
62106|NCT02195986|E1|Reported Event|Estradiol Vaginal Cream|"Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days.~Estradiol Vaginal Cream, 0.01%: Estradiol Vaginal Cream, 0.01% (1 x 2 g for 7 days)"
62107|NCT02195713|B3|Baseline|Total|Total of all reporting groups
62108|NCT02195713|B2|Baseline|Control- Critcore Urine Output Monitor|A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.
62109|NCT02195713|B1|Baseline|Test- Accuryn Urine Output Monitor|"Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.~Accuryn: Accuryn is a novel electronic urine output monitor"
62110|NCT02195713|P2|Participant Flow|Control- Critcore Urine Output Monitor|A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.
62111|NCT02195713|P1|Participant Flow|Test- Accuryn Urine Output Monitor|"Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.~Accuryn: Accuryn is a novel electronic urine output monitor"
62112|NCT02195713|O2|Outcome|Control- Critcore Urine Output Monitor|A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.
62113|NCT02195713|O1|Outcome|Test- Accuryn Urine Output Monitor|"Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.~Accuryn: Accuryn is a novel electronic urine output monitor"
62114|NCT02195713|E2|Reported Event|Control- Critcore Urine Output Monitor|A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.
62115|NCT02195713|E1|Reported Event|Test- Accuryn Urine Output Monitor|"Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.~Accuryn: Accuryn is a novel electronic urine output monitor"
62116|NCT02195700|B3|Baseline|Total|Total of all reporting groups
62117|NCT02195700|B2|Baseline|Placebo|"Patients underwent 'dose adjustment' of placebo over the initial 6 weeks of treatment. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout.~Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment."
62118|NCT02195700|B1|Baseline|SD-809|"Patients underwent dose adjustment of SD-809 over the initial 6 weeks of treatment, starting treatment with SD-809 at 6 mg twice daily and titrating to a maximum total daily dose of 48 mg per day. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout.~Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment."
62119|NCT02195700|P2|Participant Flow|Placebo|Patients underwent 'dose adjustment' of placebo over the initial 6 weeks of treatment. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout. Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment.
62120|NCT02195700|P1|Participant Flow|SD-809|"Patients underwent dose adjustment of SD-809 over the initial 6 weeks of treatment, starting treatment with SD-809 at 6 mg twice daily and titrating to a maximum total daily dose of 48 mg per day. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout.~Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment."
62121|NCT02195700|O2|Outcome|Placebo|Patients underwent 'dose adjustment' of placebo over the initial 6 weeks of treatment. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout. Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment.
62122|NCT02195700|O1|Outcome|SD-809|"Patients underwent dose adjustment of SD-809 over the initial 6 weeks of treatment, starting treatment with SD-809 at 6 mg twice daily and titrating to a maximum total daily dose of 48 mg per day. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout.~Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment."
62123|NCT02195700|O2|Outcome|Placebo|Patients underwent 'dose adjustment' of placebo over the initial 6 weeks of treatment. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout. Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment.
62124|NCT02195700|O1|Outcome|SD-809|"Patients underwent dose adjustment of SD-809 over the initial 6 weeks of treatment, starting treatment with SD-809 at 6 mg twice daily and titrating to a maximum total daily dose of 48 mg per day. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout.~Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment."
62142|NCT02195687|P2|Participant Flow|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
62125|NCT02195700|O2|Outcome|Placebo|Patients underwent 'dose adjustment' of placebo over the initial 6 weeks of treatment. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout. Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment.
62126|NCT02195700|O1|Outcome|SD-809|"Patients underwent dose adjustment of SD-809 over the initial 6 weeks of treatment, starting treatment with SD-809 at 6 mg twice daily and titrating to a maximum total daily dose of 48 mg per day. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout.~Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment."
62127|NCT02195700|O2|Outcome|Placebo|Patients underwent 'dose adjustment' of placebo over the initial 6 weeks of treatment. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout. Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment.
62128|NCT02195700|O1|Outcome|SD-809|"Patients underwent dose adjustment of SD-809 over the initial 6 weeks of treatment, starting treatment with SD-809 at 6 mg twice daily and titrating to a maximum total daily dose of 48 mg per day. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout.~Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment."
62129|NCT02195700|O2|Outcome|Placebo|Patients underwent 'dose adjustment' of placebo over the initial 6 weeks of treatment. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout. Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment.
62130|NCT02195700|O1|Outcome|SD-809|"Patients underwent dose adjustment of SD-809 over the initial 6 weeks of treatment, starting treatment with SD-809 at 6 mg twice daily and titrating to a maximum total daily dose of 48 mg per day. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout.~Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment."
62131|NCT02195700|O2|Outcome|Placebo|Patients underwent 'dose adjustment' of placebo over the initial 6 weeks of treatment. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout. Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment.
62132|NCT02195700|O1|Outcome|SD-809|"Patients underwent dose adjustment of SD-809 over the initial 6 weeks of treatment, starting treatment with SD-809 at 6 mg twice daily and titrating to a maximum total daily dose of 48 mg per day. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout.~Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment."
62133|NCT02195700|O2|Outcome|Placebo|Patients underwent 'dose adjustment' of placebo over the initial 6 weeks of treatment. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout. Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment.
62134|NCT02195700|O1|Outcome|SD-809|"Patients underwent dose adjustment of SD-809 over the initial 6 weeks of treatment, starting treatment with SD-809 at 6 mg twice daily and titrating to a maximum total daily dose of 48 mg per day. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout.~Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment."
62135|NCT02195700|O2|Outcome|Placebo|Patients underwent 'dose adjustment' of placebo over the initial 6 weeks of treatment. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout. Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment.
62136|NCT02195700|O1|Outcome|SD-809|"Patients underwent dose adjustment of SD-809 over the initial 6 weeks of treatment, starting treatment with SD-809 at 6 mg twice daily and titrating to a maximum total daily dose of 48 mg per day. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout.~Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment."
62137|NCT02195700|E2|Reported Event|Placebo|Patients underwent 'dose adjustment' of placebo over the initial 6 weeks of treatment. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout. Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment.
62138|NCT02195700|E1|Reported Event|SD-809|"Patients underwent dose adjustment of SD-809 over the initial 6 weeks of treatment, starting treatment with SD-809 at 6 mg twice daily and titrating to a maximum total daily dose of 48 mg per day. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout.~Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment."
62139|NCT02195687|B3|Baseline|Total|Total of all reporting groups
62143|NCT02195687|P1|Participant Flow|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
62144|NCT02195687|O2|Outcome|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
62145|NCT02195687|O1|Outcome|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
62146|NCT02195687|O2|Outcome|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
62147|NCT02195687|O1|Outcome|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
62148|NCT02195687|O2|Outcome|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
62149|NCT02195687|O1|Outcome|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
62150|NCT02195687|O2|Outcome|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
62151|NCT02195687|O1|Outcome|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
62152|NCT02195687|O2|Outcome|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
62153|NCT02195687|O1|Outcome|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
62154|NCT02195687|O2|Outcome|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
62155|NCT02195687|O1|Outcome|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
62156|NCT02195687|E2|Reported Event|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
62157|NCT02195687|E1|Reported Event|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
62158|NCT02195583|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline characteristics
62159|NCT02195583|P1|Participant Flow|Overall Participants|"Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 seconds (sec) to create dentifrice slurry. Then swished the slurry around the palatal appliance for 1 minute (min) and 35 sec. Next, they expectorated the slurry, rinsed with 15 milliliter (mL) of tap water for 10 sec and expectorated. There was a 2 day washout period before each treatment period when participants used a non-fluoridated dentifrice.~Sodium fluoride (1426 ppm):Non-zinc, 1426ppm fluoride as sodium fluoride in silica base~Sodium fluoride (1150 ppm):Non-zinc, 1150ppm fluoride as sodium fluoride in silica base~Sodium fluoride (250 ppm):Non-zinc, 250ppm fluoride as sodium fluoride in silica base~Sodium fluoride (1426 ppm) + zinc base A:Zinc base A, 1426ppm fluoride as sodium fluoride in silica base~Sodium fluoride (1426 ppm) + zinc base B:Zinc base B, 1426ppm fluoride as sodium fluoride in silica base~Sodium fluoride (0 ppm):Non-zinc, 0ppm fluoride in silica base"
62160|NCT02195583|O6|Outcome|Sodium Fluoride (0 Ppm)|Sodium fluoride (0 ppm) Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62161|NCT02195583|O5|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base B|Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62162|NCT02195583|O4|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base A|Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62163|NCT02195583|O3|Outcome|Sodium Fluoride (250 Ppm)|Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62164|NCT02195583|O2|Outcome|Sodium Fluoride (1150 Ppm)|Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62165|NCT02195583|O1|Outcome|Sodium Fluoride (1426 Ppm)|Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62234|NCT02195427|O1|Outcome|TEOSYAL® RHA Global Action|Injection of TEOSYAL® RHA Global Action into one NLF
62235|NCT02195427|O4|Outcome|Juvéderm® Ultra XC (RHA DL)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
62236|NCT02195427|O3|Outcome|TEOSYAL® RHA Deep Lines|Injection of TEOSYAL® RHA Deep Lines into one NLF
63778|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
62166|NCT02195583|O6|Outcome|Sodium Fluoride (0 Ppm)|Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62167|NCT02195583|O5|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base B|Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62168|NCT02195583|O4|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base A|Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62169|NCT02195583|O3|Outcome|Sodium Fluoride (250 Ppm)|Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62170|NCT02195583|O2|Outcome|Sodium Fluoride (1150 Ppm)|Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62171|NCT02195583|O1|Outcome|Sodium Fluoride (1426 Ppm)|Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62172|NCT02195583|O6|Outcome|Sodium Fluoride (0 Ppm)|Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62173|NCT02195583|O5|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base B|Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62174|NCT02195583|O4|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base A|Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62175|NCT02195583|O3|Outcome|Sodium Fluoride (250 Ppm)|Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62176|NCT02195583|O2|Outcome|Sodium Fluoride (1150 Ppm)|Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62177|NCT02195583|O1|Outcome|Sodium Fluoride (1426 Ppm)|Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62178|NCT02195583|O6|Outcome|Sodium Fluoride (0 Ppm)|Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62179|NCT02195583|O5|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base B|Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62180|NCT02195583|O4|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base A|Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62181|NCT02195583|O3|Outcome|Sodium Fluoride (250 Ppm)|Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62182|NCT02195583|O2|Outcome|Sodium Fluoride (1150 Ppm)|Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62183|NCT02195583|O1|Outcome|Sodium Fluoride (1426 Ppm)|Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62184|NCT02195583|E6|Reported Event|Sodium Fluoride (0 Ppm)|Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62185|NCT02195583|E5|Reported Event|Sodium Fluoride (1426 Ppm) + Zinc Base B|Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62186|NCT02195583|E4|Reported Event|Sodium Fluoride (1426 Ppm) + Zinc Base A|Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62187|NCT02195583|E3|Reported Event|Sodium Fluoride (250 Ppm)|Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62188|NCT02195583|E2|Reported Event|Sodium Fluoride (1150 Ppm)|Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62189|NCT02195583|E1|Reported Event|Sodium Fluoride (1426 Ppm)|Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
62190|NCT02195427|B3|Baseline|Total|Total of all reporting groups
62191|NCT02195427|B2|Baseline|TEOSYAL RHA Deep Lines/Juvederm Ultra XC|Split-face injection of TEOSYAL® RHA Deep Lines into one NLF and Juvederm® Ultra XC into the contralateral NLF. Up to 3.0 mL injected per NLF (mid-dermis to deep-dermis). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).
62192|NCT02195427|B1|Baseline|TEOSYAL RHA Global Action/Juvederm Ultra XC|Split-face injection of TEOSYAL® RHA Global Action into one NLF and Juvederm® Ultra XC into the contralateral NLF. Up to 3.0 mL injected per NLF (mid-dermis to deep-dermis). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).
62237|NCT02195427|O2|Outcome|Juvéderm® Ultra XC (RHA GA)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
62238|NCT02195427|O1|Outcome|TEOSYAL® RHA Global Action|Injection of TEOSYAL® RHA Global Action into one NLF
62193|NCT02195427|P2|Participant Flow|TEOSYAL RHA Deep Lines/Juvederm Ultra XC|"Split-face injection of TEOSYAL® RHA Deep Lines into one NLF and Juvederm® Ultra XC into the contralateral NLF. Up to 3.0 mL injected per NLF (mid-dermis to deep-dermis). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).~TEOSYAL® RHA Deep Lines: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 27G1/2” disposable sterile needles."
62194|NCT02195427|P1|Participant Flow|TEOSYAL RHA Global Action/Juvederm Ultra XC|"Split-face injection of TEOSYAL® RHA Global Action into one NLF and Juvederm® Ultra XC into the contralateral NLF. Up to 3.0 mL injected per NLF (mid-dermis to deep-dermis). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).~TEOSYAL® RHA Global Action: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 30G1/2” disposable sterile needles."
62195|NCT02195427|O4|Outcome|Juvéderm® Ultra XC (RHA DL)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
62196|NCT02195427|O3|Outcome|TEOSYAL® RHA Deep Lines|Injection of TEOSYAL® RHA Deep Lines into one NLF
62197|NCT02195427|O2|Outcome|Juvéderm® Ultra XC (RHA GA)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
62198|NCT02195427|O1|Outcome|TEOSYAL® RHA Global Action|Injection of TEOSYAL® RHA Global Action into one NLF
62199|NCT02195427|O4|Outcome|Juvéderm® Ultra XC (RHA DL)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
62200|NCT02195427|O3|Outcome|TEOSYAL® RHA Deep Lines|Injection of TEOSYAL® RHA Deep Lines into one NLF
62201|NCT02195427|O2|Outcome|Juvéderm® Ultra XC (RHA GA)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
62202|NCT02195427|O1|Outcome|TEOSYAL® RHA Global Action|Injection of TEOSYAL® RHA Global Action into one NLF
62203|NCT02195427|O4|Outcome|Juvéderm® Ultra XC (RHA DL)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
62204|NCT02195427|O3|Outcome|TEOSYAL® RHA Deep Lines|Injection of TEOSYAL® RHA Deep Lines into one NLF
62205|NCT02195427|O2|Outcome|Juvéderm® Ultra XC (RHA GA)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
62206|NCT02195427|O1|Outcome|TEOSYAL® RHA Global Action|Injection of TEOSYAL® RHA Global Action into one NLF
62207|NCT02195427|O4|Outcome|Juvéderm® Ultra XC (RHA DL)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
62208|NCT02195427|O3|Outcome|TEOSYAL® RHA Deep Lines|Injection of TEOSYAL® RHA Deep Lines into one NLF
62209|NCT02195427|O2|Outcome|Juvéderm® Ultra XC (RHA GA)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
62210|NCT02195427|O1|Outcome|TEOSYAL® RHA Global Action|Injection of TEOSYAL® RHA Global Action into one NLF
62211|NCT02195427|O4|Outcome|Juvéderm® Ultra XC (RHA DL)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
62212|NCT02195427|O3|Outcome|TEOSYAL® RHA Deep Lines|Injection of TEOSYAL® RHA Deep Lines into one NLF
62213|NCT02195427|O2|Outcome|Juvéderm® Ultra XC (RHA GA)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
62214|NCT02195427|O1|Outcome|TEOSYAL® RHA Global Action|Injection of TEOSYAL® RHA Global Action into one NLF
62215|NCT02195427|O4|Outcome|Juvéderm® Ultra XC (RHA DL)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
62216|NCT02195427|O3|Outcome|TEOSYAL® RHA Deep Lines|Injection of TEOSYAL® RHA Deep Lines into one NLF
62217|NCT02195427|O2|Outcome|Juvéderm® Ultra XC (RHA GA)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
62218|NCT02195427|O1|Outcome|TEOSYAL® RHA Global Action|Injection of TEOSYAL® RHA Global Action into one NLF
62219|NCT02195427|O4|Outcome|Juvéderm® Ultra XC (RHA DL)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
62220|NCT02195427|O3|Outcome|TEOSYAL® RHA Deep Lines|Injection of TEOSYAL® RHA Deep Lines into one NLF
62221|NCT02195427|O2|Outcome|Juvéderm® Ultra XC (RHA GA)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
62222|NCT02195427|O1|Outcome|TEOSYAL® RHA Global Action|Injection of TEOSYAL® RHA Global Action into one NLF
62223|NCT02195427|O4|Outcome|Juvéderm® Ultra XC (RHA DL)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
62224|NCT02195427|O3|Outcome|TEOSYAL® RHA Deep Lines|Injection of TEOSYAL® RHA Deep Lines into one NLF
62225|NCT02195427|O2|Outcome|Juvéderm® Ultra XC (RHA GA)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
62226|NCT02195427|O1|Outcome|TEOSYAL® RHA Global Action|Injection of TEOSYAL® RHA Global Action into one NLF
62227|NCT02195427|O4|Outcome|Juvéderm® Ultra XC (RHA DL)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
62228|NCT02195427|O3|Outcome|TEOSYAL® RHA Deep Lines|Injection of TEOSYAL® RHA Deep Lines into one NLF
62229|NCT02195427|O2|Outcome|Juvéderm® Ultra XC (RHA GA)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
62230|NCT02195427|O1|Outcome|TEOSYAL® RHA Global Action|Injection of TEOSYAL® RHA Global Action into one NLF
62231|NCT02195427|O4|Outcome|Juvéderm® Ultra XC (RHA DL)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
62232|NCT02195427|O3|Outcome|TEOSYAL® RHA Deep Lines|Injection of TEOSYAL® RHA Deep Lines into one NLF
62233|NCT02195427|O2|Outcome|Juvéderm® Ultra XC (RHA GA)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
62239|NCT02195427|O4|Outcome|Juvéderm® Ultra XC (RHA DL)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
62240|NCT02195427|O3|Outcome|TEOSYAL® RHA Deep Lines|Injection of TEOSYAL® RHA Deep Lines into one NLF
62241|NCT02195427|O2|Outcome|Juvéderm® Ultra XC (RHA GA)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
62242|NCT02195427|O1|Outcome|TEOSYAL® RHA Global Action|Injection of TEOSYAL® RHA Global Action into one NLF
62243|NCT02195427|O4|Outcome|Juvéderm® Ultra XC (RHA DL)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
62244|NCT02195427|O3|Outcome|TEOSYAL® RHA Deep Lines|Injection of TEOSYAL® RHA Deep Lines into one NLF
62245|NCT02195427|O2|Outcome|Juvéderm® Ultra XC (RHA GA)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
62246|NCT02195427|O1|Outcome|TEOSYAL® RHA Global Action|Injection of TEOSYAL® RHA Global Action into one NLF
62247|NCT02195427|O4|Outcome|Juvéderm® Ultra XC (RHA DL)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
62248|NCT02195427|O3|Outcome|TEOSYAL® RHA Deep Lines|Injection of TEOSYAL® RHA Deep Lines into one NLF
62249|NCT02195427|O2|Outcome|Juvéderm® Ultra XC (RHA GA)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
62250|NCT02195427|O1|Outcome|TEOSYAL® RHA Global Action|Injection of TEOSYAL® RHA Global Action into one NLF
62251|NCT02195427|E4|Reported Event|Juvéderm® Ultra XC (RHA DL)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
62252|NCT02195427|E3|Reported Event|TEOSYAL® RHA Deep Lines|Injection of TEOSYAL® RHA Deep Lines into one NLF
62253|NCT02195427|E2|Reported Event|Juvéderm® Ultra XC (RHA GA)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
62254|NCT02195427|E1|Reported Event|TEOSYAL® RHA Global Action|Injection of TEOSYAL® RHA Global Action into one NLF
62255|NCT02195414|B1|Baseline|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
62256|NCT02195414|P1|Participant Flow|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
62257|NCT02195414|O1|Outcome|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
62258|NCT02195414|O1|Outcome|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
62259|NCT02195414|O1|Outcome|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
62260|NCT02195414|O1|Outcome|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
62261|NCT02195414|E1|Reported Event|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
62262|NCT02194699|B3|Baseline|Total|Total of all reporting groups
62263|NCT02194699|B2|Baseline|Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62264|NCT02194699|B1|Baseline|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62265|NCT02194699|P2|Participant Flow|Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62266|NCT02194699|P1|Participant Flow|Tralo 300 mg Q2W|Tralokinumab 300 milligrams (mg) administered subcutaneously every 2 weeks (Q2W) over a 52-week treatment period (up to 26 doses).
62267|NCT02194699|O2|Outcome|Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62268|NCT02194699|O1|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62269|NCT02194699|O3|Outcome|Total - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). 'Total' treatment arm represents all patients receiving tralokinumab in both the biomarker positive and biomarker negative patient populations.
62270|NCT02194699|O2|Outcome|Biomarker Negative - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62271|NCT02194699|O1|Outcome|Biomarker Positive - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62272|NCT02194699|O6|Outcome|Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62273|NCT02194699|O5|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62274|NCT02194699|O4|Outcome|Biomarker Negative - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62275|NCT02194699|O3|Outcome|Biomarker Negative - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62276|NCT02194699|O2|Outcome|Biomarker Positive - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62277|NCT02194699|O1|Outcome|Biomarker Positive - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62544|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
62278|NCT02194699|O6|Outcome|Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62279|NCT02194699|O5|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62280|NCT02194699|O4|Outcome|Biomarker Negative - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62281|NCT02194699|O3|Outcome|Biomarker Negative - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62282|NCT02194699|O2|Outcome|Biomarker Positive - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62283|NCT02194699|O1|Outcome|Biomarker Positive - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62284|NCT02194699|O6|Outcome|Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62285|NCT02194699|O5|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62286|NCT02194699|O4|Outcome|Biomarker Negative - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62287|NCT02194699|O3|Outcome|Biomarker Negative - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62288|NCT02194699|O2|Outcome|Biomarker Positive - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62289|NCT02194699|O1|Outcome|Biomarker Positive - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62290|NCT02194699|O6|Outcome|Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62291|NCT02194699|O5|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62292|NCT02194699|O4|Outcome|Biomarker Negative - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62293|NCT02194699|O3|Outcome|Biomarker Negative - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62294|NCT02194699|O2|Outcome|Biomarker Positive - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62295|NCT02194699|O1|Outcome|Biomarker Positive - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62296|NCT02194699|O6|Outcome|Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62297|NCT02194699|O5|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62298|NCT02194699|O4|Outcome|Biomarker Negative - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62299|NCT02194699|O3|Outcome|Biomarker Negative - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62300|NCT02194699|O2|Outcome|Biomarker Positive - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62301|NCT02194699|O1|Outcome|Biomarker Positive - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62302|NCT02194699|O6|Outcome|Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62303|NCT02194699|O5|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62304|NCT02194699|O4|Outcome|Biomarker Negative - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62305|NCT02194699|O3|Outcome|Biomarker Negative - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62306|NCT02194699|O2|Outcome|Biomarker Positive - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62307|NCT02194699|O1|Outcome|Biomarker Positive - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62308|NCT02194699|O6|Outcome|Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62309|NCT02194699|O5|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62310|NCT02194699|O4|Outcome|Biomarker Negative - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62545|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
62311|NCT02194699|O3|Outcome|Biomarker Negative - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62312|NCT02194699|O2|Outcome|Biomarker Positive - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62313|NCT02194699|O1|Outcome|Biomarker Positive - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62314|NCT02194699|O6|Outcome|Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62315|NCT02194699|O5|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62316|NCT02194699|O4|Outcome|Biomarker Negative - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62317|NCT02194699|O3|Outcome|Biomarker Negative - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62318|NCT02194699|O2|Outcome|Biomarker Positive - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62319|NCT02194699|O1|Outcome|Biomarker Positive - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62320|NCT02194699|O6|Outcome|Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62321|NCT02194699|O5|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62322|NCT02194699|O4|Outcome|Biomarker Negative - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62323|NCT02194699|O3|Outcome|Biomarker Negative - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62324|NCT02194699|O2|Outcome|Biomarker Positive - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62325|NCT02194699|O1|Outcome|Biomarker Positive - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62326|NCT02194699|O6|Outcome|Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62327|NCT02194699|O5|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62328|NCT02194699|O4|Outcome|Biomarker Negative - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62329|NCT02194699|O3|Outcome|Biomarker Negative - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62330|NCT02194699|O2|Outcome|Biomarker Positive - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62331|NCT02194699|O1|Outcome|Biomarker Positive - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62332|NCT02194699|O6|Outcome|Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62333|NCT02194699|O5|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62334|NCT02194699|O4|Outcome|Biomarker Negative - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62335|NCT02194699|O3|Outcome|Biomarker Negative - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62336|NCT02194699|O2|Outcome|Biomarker Positive - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62337|NCT02194699|O1|Outcome|Biomarker Positive - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62338|NCT02194699|O6|Outcome|Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62339|NCT02194699|O5|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62340|NCT02194699|O4|Outcome|Biomarker Negative - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62341|NCT02194699|O3|Outcome|Biomarker Negative - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62342|NCT02194699|O2|Outcome|Biomarker Positive - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62546|NCT02193178|O1|Outcome|Habitual Lenses|
62343|NCT02194699|O1|Outcome|Biomarker Positive - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62344|NCT02194699|O6|Outcome|Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62345|NCT02194699|O5|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62346|NCT02194699|O4|Outcome|Biomarker Negative - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62347|NCT02194699|O3|Outcome|Biomarker Negative - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62348|NCT02194699|O2|Outcome|Biomarker Positive - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62349|NCT02194699|O1|Outcome|Biomarker Positive - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62350|NCT02194699|O6|Outcome|Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62351|NCT02194699|O5|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62352|NCT02194699|O4|Outcome|Biomarker Negative - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62353|NCT02194699|O3|Outcome|Biomarker Negative - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62354|NCT02194699|O2|Outcome|Biomarker Positive - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62355|NCT02194699|O1|Outcome|Biomarker Positive - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62356|NCT02194699|O6|Outcome|Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62357|NCT02194699|O5|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62358|NCT02194699|O4|Outcome|Biomarker Negative - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62359|NCT02194699|O3|Outcome|Biomarker Negative - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62360|NCT02194699|O2|Outcome|Biomarker Positive - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62361|NCT02194699|O1|Outcome|Biomarker Positive - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62362|NCT02194699|O6|Outcome|Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62363|NCT02194699|O5|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62364|NCT02194699|O4|Outcome|Biomarker Negative - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62365|NCT02194699|O3|Outcome|Biomarker Negative - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
62366|NCT02194699|O2|Outcome|Biomarker Positive - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62367|NCT02194699|O1|Outcome|Biomarker Positive - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
62368|NCT02194699|E2|Reported Event|Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62369|NCT02194699|E1|Reported Event|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
62370|NCT02194621|B4|Baseline|Total|Total of all reporting groups
62371|NCT02194621|B3|Baseline|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)~Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
62372|NCT02194621|B2|Baseline|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2~Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
62373|NCT02194621|B1|Baseline|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1~Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
62374|NCT02194621|P3|Participant Flow|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)~Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
62626|NCT02193074|B3|Baseline|Total|Total of all reporting groups
62375|NCT02194621|P2|Participant Flow|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2~Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
62376|NCT02194621|P1|Participant Flow|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1~Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
62377|NCT02194621|O3|Outcome|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)~Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
62378|NCT02194621|O2|Outcome|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2~Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
62379|NCT02194621|O1|Outcome|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1~Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
62380|NCT02194621|O3|Outcome|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)~Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
62381|NCT02194621|O2|Outcome|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2~Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
62382|NCT02194621|O1|Outcome|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1~Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
62383|NCT02194621|O3|Outcome|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)~Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
62384|NCT02194621|O2|Outcome|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2~Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
62385|NCT02194621|O1|Outcome|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1~Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
62386|NCT02194621|O3|Outcome|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)~Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
62387|NCT02194621|O2|Outcome|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2~Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
62388|NCT02194621|O1|Outcome|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1~Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
62389|NCT02194621|E3|Reported Event|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)~Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
62390|NCT02194621|E2|Reported Event|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2~Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
62391|NCT02194621|E1|Reported Event|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1~Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
62392|NCT02194088|B3|Baseline|Total|Total of all reporting groups
62393|NCT02194088|B2|Baseline|Placebo|"Placebo capsules will be delivered in same number as the medication~Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking."
62394|NCT02194088|B1|Baseline|Pain Medication: Diclofenac and Atropine|"Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose~Diclofenac and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg"
62395|NCT02194088|P2|Participant Flow|Placebo|"Placebo capsules will be delivered in same number as the medication~Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking."
62396|NCT02194088|P1|Participant Flow|Pain Medication: Diclofenac and Atropine|"Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose~Diclofenac and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg"
62397|NCT02194088|O2|Outcome|Placebo|"Placebo capsules will be delivered in same number as the medication~Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking."
62398|NCT02194088|O1|Outcome|Pain Medication: Diclofenac and Atropine|"Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose~Diclofenac and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg"
62399|NCT02194088|O2|Outcome|Placebo|
62400|NCT02194088|O1|Outcome|Pain Medication:Diclofenac an Atropine|
62401|NCT02194088|O2|Outcome|Placebo|"Placebo capsules will be delivered in same number as the medication~Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking."
63779|NCT02185105|O3|Outcome|No Preference|
62402|NCT02194088|O1|Outcome|Pain Medication: Diclofenac and Atropine|"Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose~Diclofenac and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg"
62403|NCT02194088|E2|Reported Event|Placebo|"Placebo capsules will be delivered in same number as the medication~Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking."
62404|NCT02194088|E1|Reported Event|Pain Medication: Diclofenac and Atropine|"Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose~Diclofenac and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg"
62405|NCT02194062|B4|Baseline|Total|Total of all reporting groups
62406|NCT02194062|B3|Baseline|Budesonide Head Forward|"Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.~Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day"
62407|NCT02194062|B2|Baseline|Budesonide Respule in Head Upright|"Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day~Budesonide: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day"
62408|NCT02194062|B1|Baseline|Fluticasone Nasal Spray|"Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)~fluticasone nasal spray: use 2-50 mcg sprays to each nostril two times per day"
62409|NCT02194062|P3|Participant Flow|Budesonide Head Forward|"Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.~Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day"
62410|NCT02194062|P2|Participant Flow|Budesonide Respule in Head Upright|"Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day~Budesonide: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day"
62411|NCT02194062|P1|Participant Flow|Fluticasone Nasal Spray|"Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)~fluticasone nasal spray: use 2-50 mcg sprays to each nostril two times per day"
62412|NCT02194062|O3|Outcome|Budesonide Head Forward|"Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.~Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day"
62413|NCT02194062|O2|Outcome|Budesonide Respule in Head Upright|"Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day~Budesonide: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day"
62414|NCT02194062|O1|Outcome|Fluticasone Nasal Spray|"Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)~fluticasone nasal spray: use 2-50 mcg sprays to each nostril two times per day"
62415|NCT02194062|O3|Outcome|Budesonide Head Forward|"Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.~Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day"
62416|NCT02194062|O2|Outcome|Budesonide Respule in Head Upright|"Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day~Budesonide: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day"
62417|NCT02194062|O1|Outcome|Fluticasone Nasal Spray|"Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)~fluticasone nasal spray: use 2-50 mcg sprays to each nostril two times per day"
62418|NCT02194062|E3|Reported Event|Budesonide Head Forward|budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.
62419|NCT02194062|E2|Reported Event|Budesonide Respule in Head Upright|Budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day
62420|NCT02194062|E1|Reported Event|Fluticasone Group|Fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)
62421|NCT02193828|B5|Baseline|Total|Total of all reporting groups
62422|NCT02193828|B4|Baseline|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
62423|NCT02193828|B3|Baseline|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
62424|NCT02193828|B2|Baseline|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
62425|NCT02193828|B1|Baseline|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
62426|NCT02193828|P4|Participant Flow|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
62427|NCT02193828|P3|Participant Flow|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
62428|NCT02193828|P2|Participant Flow|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
62429|NCT02193828|P1|Participant Flow|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
62430|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
62431|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
62432|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
62433|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
62434|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
62435|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
62436|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
62437|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
62438|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
62439|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
62440|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
62441|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
62442|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
62443|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
62444|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
62445|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
62446|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
62447|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
62448|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
62449|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
62450|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
62451|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
62452|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
62453|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
62454|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
62455|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
62456|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
62457|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
62458|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
62459|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
62460|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
62461|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
62462|NCT02193828|E4|Reported Event|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
62463|NCT02193828|E3|Reported Event|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
62464|NCT02193828|E2|Reported Event|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
62465|NCT02193828|E1|Reported Event|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
62466|NCT02193815|B1|Baseline|All Participants|Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
62467|NCT02193815|P1|Participant Flow|All Participants|Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
62468|NCT02193815|O1|Outcome|All Participants|Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
62469|NCT02193815|O1|Outcome|All Participants|Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
62470|NCT02193815|O6|Outcome|Daivonex Ointment|All participants who received calcipotriol ointment (50 micrograms per gram [mcg/g]) topically once daily for 11 days.
62471|NCT02193815|O5|Outcome|Daivonex Solution|All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
62472|NCT02193815|O4|Outcome|Tofacitinib Vehicle|All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
62473|NCT02193815|O3|Outcome|Tofacitinib 2% Ointment|All participants who received tofacitinib 2% ointment topically once daily for 11 days.
62474|NCT02193815|O2|Outcome|PF-06263276 Vehicle|All participants who received PF-06263276 vehicle (active ingredient-free) topically once daily for 11 days.
62475|NCT02193815|O1|Outcome|PF-06263276 4% Solution|All participants who received PF-06263276 4% solution topically once daily for 11 days.
62476|NCT02193815|O6|Outcome|Daivonex Ointment|All participants who received calcipotriol ointment (50 micrograms per gram [mcg/g]) topically once daily for 11 days.
62477|NCT02193815|O5|Outcome|Daivonex Solution|All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
62478|NCT02193815|O4|Outcome|Tofacitinib Vehicle|All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
62479|NCT02193815|O3|Outcome|Tofacitinib 2% Ointment|All participants who received tofacitinib 2% ointment topically once daily for 11 days.
62480|NCT02193815|O2|Outcome|PF-06263276 Vehicle|All participants who received PF-06263276 vehicle (active ingredient-free) topically once daily for 11 days.
62481|NCT02193815|O1|Outcome|PF-06263276 4% Solution|All participants who received PF-06263276 4% solution topically once daily for 11 days.
62482|NCT02193815|O6|Outcome|Daivonex Ointment|All participants who received calcipotriol ointment (50 micrograms per gram [mcg/g]) topically once daily for 11 days.
62483|NCT02193815|O5|Outcome|Daivonex Solution|All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
62484|NCT02193815|O4|Outcome|Tofacitinib Vehicle|All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
62485|NCT02193815|O3|Outcome|Tofacitinib 2% Ointment|All participants who received tofacitinib 2% ointment topically once daily for 11 days.
62486|NCT02193815|O2|Outcome|PF-06263276 Vehicle|All participants who received PF-06263276 vehicle (active ingredient-free) topically once daily for 11 days.
62487|NCT02193815|O1|Outcome|PF-06263276 4% Solution|All participants who received PF-06263276 4% solution topically once daily for 11 days.
62488|NCT02193815|O6|Outcome|Daivonex Ointment|All participants who received calcipotriol ointment (50 micrograms per gram [mcg/g]) topically once daily for 11 days.
62489|NCT02193815|O5|Outcome|Daivonex Solution|All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
62490|NCT02193815|O4|Outcome|Tofacitinib Vehicle|All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
62491|NCT02193815|O3|Outcome|Tofacitinib 2% Ointment|All participants who received tofacitinib 2% ointment topically once daily for 11 days.
62492|NCT02193815|O2|Outcome|PF-06263276 Vehicle|All participants who received PF-06263276 vehicle (active ingredient-free) topically once daily for 11 days.
62493|NCT02193815|O1|Outcome|PF-06263276 4% Solution|All participants who received PF-06263276 4% solution topically once daily for 11 days.
62494|NCT02193815|O2|Outcome|Tofacitinib Vehicle|All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
62495|NCT02193815|O1|Outcome|Tofacitinib 2% Ointment|All participants who received tofacitinib 2% ointment topically once daily for 11 days.
62496|NCT02193815|O2|Outcome|Daivonex Solution|All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
62497|NCT02193815|O1|Outcome|PF-06263276 4% Solution|All participants who received PF-06263276 4% solution topically once daily for 11 days.
62498|NCT02193815|O2|Outcome|PF-06263276 Vehicle|All participants who received PF-06263276 vehicle (active ingredient- free) topically once daily for 11 days.
62499|NCT02193815|O1|Outcome|PF-06263276 4% Solution|All participants who received PF-06263276 4% solution topically once daily for 11 days.
62500|NCT02193815|E1|Reported Event|All Participants|Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
62501|NCT02193178|B1|Baseline|Overall Baseline Characteristics|Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
62502|NCT02193178|P1|Participant Flow|Overall Participants|Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
62503|NCT02193178|O2|Outcome|2 Weeks|
62504|NCT02193178|O1|Outcome|Baseline|
62505|NCT02193178|O2|Outcome|2 Weeks|
62506|NCT02193178|O1|Outcome|Baseline|
62507|NCT02193178|O2|Outcome|2 Weeks|
62508|NCT02193178|O1|Outcome|Baseline|
62509|NCT02193178|O2|Outcome|2 Weeks|
62510|NCT02193178|O1|Outcome|Baseline|
62511|NCT02193178|O2|Outcome|2 Weeks|
62512|NCT02193178|O1|Outcome|Baseline|
62513|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
62514|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
62515|NCT02193178|O1|Outcome|Habitual Lenses|
62516|NCT02193178|O4|Outcome|Conjunctival Indentation (2 Weeks)|
62517|NCT02193178|O3|Outcome|Conjunctival Staining (2 Weeks)|
62518|NCT02193178|O2|Outcome|Conjunctival Indentation (Baseline)|
62519|NCT02193178|O1|Outcome|Conjunctival Staining (Baseline)|
62520|NCT02193178|O2|Outcome|Comfilcon A – 2 Weeks|
62521|NCT02193178|O1|Outcome|Comfilcon A – Baseline|
62522|NCT02193178|O2|Outcome|Comfilcon A – 2 Weeks|
62523|NCT02193178|O1|Outcome|Comfilcon A – Baseline|
62524|NCT02193178|O2|Outcome|Comfilcon A – 2 Weeks|
62525|NCT02193178|O1|Outcome|Comfilcon A – Baseline|
62526|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
62527|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
62528|NCT02193178|O1|Outcome|Habitual Lenses|
62529|NCT02193178|O3|Outcome|2 Weeks|
62530|NCT02193178|O2|Outcome|Baseline|
62531|NCT02193178|O1|Outcome|Habitual Lenses|
62532|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
62533|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
62534|NCT02193178|O1|Outcome|Habitual Lenses|
62535|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
62536|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
62537|NCT02193178|O1|Outcome|Habitual Lenses|
62538|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
62539|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
62540|NCT02193178|O1|Outcome|Habitual Lenses|
62541|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
62542|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
62543|NCT02193178|O1|Outcome|Habitual Lenses|
62547|NCT02193178|E1|Reported Event|Comfilcon A Toric XR MTO|"Participants are habitual contact lens wearers and will be fitted with comfilcon A Toric XR MTO lenses.~comfilcon A Toric XR (MTO) contact lenses"
62548|NCT02193165|B4|Baseline|Total|Total of all reporting groups
62549|NCT02193165|B3|Baseline|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
62550|NCT02193165|B2|Baseline|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
62551|NCT02193165|B1|Baseline|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
62552|NCT02193165|P3|Participant Flow|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
62553|NCT02193165|P2|Participant Flow|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
62554|NCT02193165|P1|Participant Flow|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
62555|NCT02193165|O3|Outcome|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
62556|NCT02193165|O2|Outcome|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
62557|NCT02193165|O1|Outcome|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
62558|NCT02193165|O3|Outcome|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
62559|NCT02193165|O2|Outcome|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
62560|NCT02193165|O1|Outcome|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
62561|NCT02193165|O3|Outcome|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
62562|NCT02193165|O2|Outcome|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
62563|NCT02193165|O1|Outcome|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
62564|NCT02193165|O3|Outcome|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
62565|NCT02193165|O2|Outcome|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
62566|NCT02193165|O1|Outcome|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
62567|NCT02193165|O3|Outcome|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
62568|NCT02193165|O2|Outcome|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
62569|NCT02193165|O1|Outcome|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
62570|NCT02193165|O3|Outcome|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
62571|NCT02193165|O2|Outcome|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
62572|NCT02193165|O1|Outcome|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
62573|NCT02193165|E3|Reported Event|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
62574|NCT02193165|E2|Reported Event|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
62575|NCT02193165|E1|Reported Event|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
62576|NCT02193087|B5|Baseline|Total|Total of all reporting groups
62577|NCT02193087|B4|Baseline|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
62578|NCT02193087|B3|Baseline|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
62579|NCT02193087|B2|Baseline|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
62580|NCT02193087|B1|Baseline|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
62581|NCT02193087|P4|Participant Flow|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
62582|NCT02193087|P3|Participant Flow|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
62583|NCT02193087|P2|Participant Flow|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
62584|NCT02193087|P1|Participant Flow|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
62585|NCT02193087|O4|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
62586|NCT02193087|O3|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
62587|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
62588|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
62589|NCT02193087|O4|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
62590|NCT02193087|O3|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
62591|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
62627|NCT02193074|B2|Baseline|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
63780|NCT02185105|O2|Outcome|Comfilcon A Toric|
62592|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
62593|NCT02193087|O4|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
62594|NCT02193087|O3|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
62595|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
62596|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
62597|NCT02193087|O4|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
62598|NCT02193087|O3|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
62599|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
62600|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
62601|NCT02193087|O4|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
62602|NCT02193087|O3|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
62603|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
62604|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
62605|NCT02193087|O4|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
62606|NCT02193087|O3|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
62607|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
62608|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
62609|NCT02193087|O5|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
62610|NCT02193087|O4|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
62611|NCT02193087|O3|Outcome|Group A and Group B Combined|"Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).~Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3)."
62612|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
62613|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
62614|NCT02193087|O2|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
62615|NCT02193087|O1|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
62616|NCT02193087|O2|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
62617|NCT02193087|O1|Outcome|Group A + Group B Combined|"Group A: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).~Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3)."
62618|NCT02193087|O2|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
62619|NCT02193087|O1|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
62620|NCT02193087|O2|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
62621|NCT02193087|O1|Outcome|Group A + Group B Combined|"Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).~Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3)."
62622|NCT02193087|E4|Reported Event|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
62623|NCT02193087|E3|Reported Event|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
62624|NCT02193087|E2|Reported Event|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
62625|NCT02193087|E1|Reported Event|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
62628|NCT02193074|B1|Baseline|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
62629|NCT02193074|P2|Participant Flow|Nusinersen|Nusinersen (2.4 mg/mL) administered as an intrathecal (IT) lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
62630|NCT02193074|P1|Participant Flow|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
62631|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
62632|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
62633|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
62634|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
62635|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
62636|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
62637|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
62638|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
62639|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
62640|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
62641|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
62642|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
62643|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
62644|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
62645|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
62646|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
62647|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
62648|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
62649|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
62650|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
62651|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
62652|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
62653|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
62654|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
62655|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
62656|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
62657|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
62658|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
62659|NCT02193074|E2|Reported Event|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
62660|NCT02193074|E1|Reported Event|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
62661|NCT02192905|B1|Baseline|Behavioral Weight Loss + Habit|"Individuals randomized to this condition will receive 8 weeks of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.~Diabetes Prevention Program Lifestyle Intervention"
62662|NCT02192905|P1|Participant Flow|Behavioral Weight Loss + Habit|"Individuals randomized to this condition will receive 8 weeks of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.~Diabetes Prevention Program Lifestyle Intervention"
62663|NCT02192905|O1|Outcome|Behavioral Weight Loss + Habit|"Participants will receive 8 weeks of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.~Diabetes Prevention Program Lifestyle Intervention"
62664|NCT02192905|O1|Outcome|Behavioral Weight Loss + Habit|"Individuals randomized to this condition will receive 8 week of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.~Diabetes Prevention Program Lifestyle Intervention"
62665|NCT02192905|O1|Outcome|Behavioral Weight Loss + Habit|"Individuals randomized to this condition will receive 8 week of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.~Diabetes Prevention Program Lifestyle Intervention"
62666|NCT02192905|O1|Outcome|Behavioral Weight Loss + Habit|"Participants will receive 8 weeks of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.~Diabetes Prevention Program Lifestyle Intervention"
62667|NCT02192905|O1|Outcome|Behavioral Weight Loss + Habit|"Participants will receive 8 weeks of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.~Diabetes Prevention Program Lifestyle Intervention"
62854|NCT02191033|P2|Participant Flow|Standard of Care|"Smoking counseling, nicotine patch~Smoking counseling~Nicotine patch"
63781|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
62668|NCT02192905|O1|Outcome|Behavioral Weight Loss + Habit|"Participants will receive 8 weeks of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.~Diabetes Prevention Program Lifestyle Intervention"
62669|NCT02192905|O1|Outcome|Behavioral Weight Loss + Habit|"Participants will receive 8 weeks of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.~Diabetes Prevention Program Lifestyle Intervention"
62670|NCT02192905|O1|Outcome|Behavioral Weight Loss + Habit|"Participants will receive 8 weeks of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.~Diabetes Prevention Program Lifestyle Intervention"
62671|NCT02192905|E1|Reported Event|Behavioral Weight Loss + Habit|"Participants will receive 8 weeks of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.~Diabetes Prevention Program Lifestyle Intervention"
62672|NCT02192879|B4|Baseline|Total|Total of all reporting groups
62673|NCT02192879|B3|Baseline|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
62674|NCT02192879|B2|Baseline|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
62675|NCT02192879|B1|Baseline|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
62676|NCT02192879|P3|Participant Flow|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
62677|NCT02192879|P2|Participant Flow|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
62678|NCT02192879|P1|Participant Flow|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
62679|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
62680|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
62681|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
62682|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
62683|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
62712|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
63782|NCT02185105|O2|Outcome|Comfilcon A Toric|
62684|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
62685|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
62686|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
62687|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
62688|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
62689|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
62690|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
62691|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
62692|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
62693|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
62694|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
62695|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
62696|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
62697|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
62740|NCT02192541|O1|Outcome|Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was started at a dose level of 100 mg/m^2 and ziv-aflibercept at 4 mg/kg.
63783|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
62698|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
62699|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
62700|NCT02192879|E3|Reported Event|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
62701|NCT02192879|E2|Reported Event|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
62702|NCT02192879|E1|Reported Event|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
62703|NCT02192814|B1|Baseline|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
62704|NCT02192814|P1|Participant Flow|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
62705|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
62706|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
62707|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
62708|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
62709|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
62710|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
62711|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
62855|NCT02191033|P1|Participant Flow|Text Messaging|"Smoking counseling, nicotine patch, text messaging~Smoking counseling~Nicotine patch~Text messaging"
62713|NCT02192814|E1|Reported Event|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was be the same as the subject's current daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
62714|NCT02192684|B3|Baseline|Total|Total of all reporting groups
62715|NCT02192684|B2|Baseline|Placebo|"Placebo, one pill daily~placebo: Compare with pioglitazone"
62716|NCT02192684|B1|Baseline|Pioglitazone|"pioglitazone 45 mg, oral, daily~Pioglitazone: 45 mg daily Insulin sensitizing"
62717|NCT02192684|P2|Participant Flow|Placebo|"Placebo, one pill daily~placebo: Compare with pioglitazone"
62718|NCT02192684|P1|Participant Flow|Pioglitazone|"pioglitazone 45 mg, oral, daily~Pioglitazone: 45 mg daily Insulin sensitizing"
62719|NCT02192684|O2|Outcome|Placebo|"Placebo, one pill daily~placebo: Compare with pioglitazone"
62720|NCT02192684|O1|Outcome|Pioglitazone|"pioglitazone 45 mg, oral, daily~Pioglitazone: 45 mg daily Insulin sensitizing"
62721|NCT02192684|E2|Reported Event|Placebo|"Placebo, one pill daily~placebo: Compare with pioglitazone"
62722|NCT02192684|E1|Reported Event|Pioglitazone|"pioglitazone 45 mg, oral, daily~Pioglitazone: 45 mg daily Insulin sensitizing"
62723|NCT02192606|B3|Baseline|Total|Total of all reporting groups
62724|NCT02192606|B2|Baseline|3D Laparoscopy|"The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.~Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system."
62725|NCT02192606|B1|Baseline|2D Laparoscopy|"The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy~2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy."
62726|NCT02192606|P2|Participant Flow|3D Laparoscopy|"The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.~Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system."
62727|NCT02192606|P1|Participant Flow|2D Laparoscopy|"The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy~2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy."
62728|NCT02192606|O2|Outcome|3D Laparoscopy|"The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.~Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system."
62729|NCT02192606|O1|Outcome|2D Laparoscopy|"The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy~2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy."
62730|NCT02192606|O2|Outcome|3D Laparoscopy|"The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.~Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system."
62731|NCT02192606|O1|Outcome|2D Laparoscopy|"The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy~2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy."
62732|NCT02192606|E2|Reported Event|3D Laparoscopy|"The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.~Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system."
62733|NCT02192606|E1|Reported Event|2D Laparoscopy|"The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy~2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy."
62734|NCT02192541|B3|Baseline|Total|Total of all reporting groups
62735|NCT02192541|B2|Baseline|Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was administered at a level of 100 mg/m^2 and ziv-aflibercept at 3 mg/kg.
62736|NCT02192541|B1|Baseline|Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was started at a dose level of 100 mg/m^2 and ziv-aflibercept at 4 mg/kg.
62737|NCT02192541|P2|Participant Flow|Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was administered at a level of 100 mg/m^2 and ziv-aflibercept at 3 mg/kg.
62738|NCT02192541|P1|Participant Flow|Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was started at a dose level of 100 mg/m^2 and ziv-aflibercept at 4 mg/kg.
62739|NCT02192541|O2|Outcome|Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was started at a dose level of 100 mg/m^2 and ziv-aflibercept at 3 mg/kg.
62847|NCT02191046|O2|Outcome|Squeezable Bottle|improve 5-s score at 2 week period after treatment when compare to the beginning status with minimal side effect and significant improve in 5-s score and satisfaction when compare to syringe group
62741|NCT02192541|O2|Outcome|Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was administered at a level of 100 mg/m^2 and ziv-aflibercept at 3 mg/kg.
62742|NCT02192541|O1|Outcome|Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was started at a dose level of 100 mg/m^2 and ziv-aflibercept at 4 mg/kg.
62743|NCT02192541|O2|Outcome|Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was administered at a level of 100 mg/m^2 and ziv-aflibercept at 3 mg/kg.
62744|NCT02192541|O1|Outcome|Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was started at a dose level of 100 mg/m^2 and ziv-aflibercept at 4 mg/kg.
62745|NCT02192541|O2|Outcome|Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was started at a dose level of 100 mg/m^2 and ziv-aflibercept at 3 mg/kg.
62746|NCT02192541|O1|Outcome|Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was started at a dose level of 100 mg/m^2 and ziv-aflibercept at 4 mg/kg.
62747|NCT02192541|O2|Outcome|Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was started at a dose level of 100 mg/m^2 and ziv-aflibercept at 3 mg/kg.
62748|NCT02192541|O1|Outcome|Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was started at a dose level of 100 mg/m^2 and ziv-aflibercept at 4 mg/kg.
62749|NCT02192541|O2|Outcome|Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was started at a dose level of 100 mg/m^2 and ziv-aflibercept at 3 mg/kg.
62750|NCT02192541|O1|Outcome|Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was started at a dose level of 100 mg/m^2 and ziv-aflibercept at 4 mg/kg.
62751|NCT02192541|O2|Outcome|Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was administered at a level of 100 mg/m^2 and ziv-aflibercept at 3 mg/kg.
62752|NCT02192541|O1|Outcome|Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was started at a dose level of 100 mg/m^2 and ziv-aflibercept at 4 mg/kg.
62753|NCT02192541|O2|Outcome|Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was administered at a level of 100 mg/m^2 and ziv-aflibercept at 3 mg/kg.
62754|NCT02192541|O1|Outcome|Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was started at a dose level of 100 mg/m^2 and ziv-aflibercept at 4 mg/kg.
62755|NCT02192541|E2|Reported Event|Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was administered at a level of 100 mg/m^2 and ziv-aflibercept at 3 mg/kg.
62756|NCT02192541|E1|Reported Event|Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was started at a dose level of 100 mg/m^2 and ziv-aflibercept at 4 mg/kg.
62757|NCT02192164|B1|Baseline|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment based on treating physician’s discretion as per Summary of Product Characteristics (SmPC) were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
62758|NCT02192164|P1|Participant Flow|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment based on treating physician’s discretion as per Summary of Product Characteristics (SmPC) were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
62848|NCT02191046|O1|Outcome|Syringe 20 ml|improve 5-s score at 2 week period after treatment when compare to the beginning status with minimal side effect
104924|NCT01955564|E4|Reported Event|Cohort 3|NW-3509a 5mg, single dose
62759|NCT02192164|O1|Outcome|Etanercept: Former Smoker + Smoker|Participants who were smokers during the study and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
62760|NCT02192164|O1|Outcome|Etanercept: Former Smoker + Smoker|Participants who were smokers during the study and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
62761|NCT02192164|O2|Outcome|Etanercept: Smokers|Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
62762|NCT02192164|O1|Outcome|Etanercept: Non Smokers|Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
62763|NCT02192164|O2|Outcome|Etanercept: Smokers|Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
62764|NCT02192164|O1|Outcome|Etanercept: Non Smokers|Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
62765|NCT02192164|O2|Outcome|Etanercept: Smokers|Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
62766|NCT02192164|O1|Outcome|Etanercept: Non Smokers|Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
62767|NCT02192164|O2|Outcome|Etanercept: Smokers|Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
62768|NCT02192164|O1|Outcome|Etanercept: Non Smokers|Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
62769|NCT02192164|O2|Outcome|Etanercept: Smokers|Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
62770|NCT02192164|O1|Outcome|Etanercept: Non Smokers|Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
62771|NCT02192164|E2|Reported Event|Etanercept: Smokers|Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
62772|NCT02192164|E1|Reported Event|Etanercept: Non Smokers|Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
62773|NCT02191865|B4|Baseline|Total|Total of all reporting groups
62774|NCT02191865|B3|Baseline|Healthy|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in subjects with normal hepatic function.
62775|NCT02191865|B2|Baseline|Child Pugh B|"Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).~Subjects were dosed in a 3 plus 5 design, where a subgroup of 3 subjects was dosed and safety was evaluated formally at a safety meeting prior to dosing the remaining 5 subjects in the group."
62776|NCT02191865|B1|Baseline|Child Pugh A|"Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).~Subjects were dosed in a 3 plus 5 design, where a subgroup of 3 subjects was dosed and safety was evaluated formally at a safety meeting prior to dosing the remaining 5 subjects in the group."
62777|NCT02191865|P3|Participant Flow|Healthy|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in subjects with normal hepatic function.
62856|NCT02191033|O2|Outcome|Standard of Care|"Smoking counseling, nicotine patch~Smoking counseling~Nicotine patch"
62778|NCT02191865|P2|Participant Flow|Child Pugh B|"Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).~Subjects were dosed in a 3 plus 5 design, where a subgroup of 3 subjects was dosed and safety was evaluated formally at a safety meeting prior to dosing the remaining 5 subjects in the group."
62779|NCT02191865|P1|Participant Flow|Child Pugh A|"Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).~Subjects were dosed in a 3 plus 5 design, where a subgroup of 3 subjects was dosed and safety was evaluated formally at a safety meeting prior to dosing the remaining 5 subjects in the group."
62780|NCT02191865|O3|Outcome|Healthy|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in subjects with normal hepatic function.
62781|NCT02191865|O2|Outcome|Child-Pugh B|Oral administration of 1 soft gelatin capsule of 100 mg Nintedanib with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).
62782|NCT02191865|O1|Outcome|Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).
62783|NCT02191865|O4|Outcome|Healthy Matched Child-Pugh B|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in healthy control subjects matched with hepatic (Child pugh B) impaired subjects .
62784|NCT02191865|O3|Outcome|Healthy Matched Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in healthy control subjects matched with hepatic (Child pugh A) impaired subjects
62785|NCT02191865|O2|Outcome|Child-Pugh B|Oral administration of 1 soft gelatin capsule of 100 mg Nintedanib with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).
62786|NCT02191865|O1|Outcome|Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).
62787|NCT02191865|O4|Outcome|Healthy Matched Child-Pugh B|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in healthy control subjects matched with hepatic (Child pugh B) impaired subjects .
62788|NCT02191865|O3|Outcome|Healthy Matched Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in healthy control subjects matched with hepatic (Child pugh A) impaired subjects
62789|NCT02191865|O2|Outcome|Child-Pugh B|Oral administration of 1 soft gelatin capsule of 100 mg Nintedanib with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).
62790|NCT02191865|O1|Outcome|Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).
62791|NCT02191865|O4|Outcome|Healthy Matched Child-Pugh B|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in healthy control subjects matched with hepatic (Child pugh B) impaired subjects .
62792|NCT02191865|O3|Outcome|Healthy Matched Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in healthy control subjects matched with hepatic (Child pugh A) impaired subjects
62793|NCT02191865|O2|Outcome|Child-Pugh B|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).
62794|NCT02191865|O1|Outcome|Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).
62795|NCT02191865|E3|Reported Event|Healthy|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in subjects with normal hepatic function.
62796|NCT02191865|E2|Reported Event|Child Pugh B|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).
62797|NCT02191865|E1|Reported Event|Child Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).
62798|NCT02191267|B4|Baseline|Total|Total of all reporting groups
62799|NCT02191267|B3|Baseline|AD Dementia Group|"Interventions administered to the AD Dementia Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
62800|NCT02191267|B2|Baseline|Control Group|"Interventions administered to the Control Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
62801|NCT02191267|B1|Baseline|Presumed CTE Group|"Interventions administered to the Presumed CTE Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
62802|NCT02191267|P3|Participant Flow|AD Dementia Group|"Interventions administered to the AD Dementia Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
62803|NCT02191267|P2|Participant Flow|Control Group|"Interventions administered to the Control Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
62804|NCT02191267|P1|Participant Flow|Presumed CTE Group|"Interventions administered to the Presumed CTE Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
62805|NCT02191267|O3|Outcome|AD Dementia Group|"Interventions administered to the AD Dementia Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
62806|NCT02191267|O2|Outcome|Control Group|"Interventions administered to the Control Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
62807|NCT02191267|O1|Outcome|Presumed CTE Group|"Interventions administered to the Presumed CTE Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
62808|NCT02191267|O3|Outcome|AD Dementia Group|"Interventions administered to the AD Dementia Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
62809|NCT02191267|O2|Outcome|Control Group|"Interventions administered to the Control Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
62810|NCT02191267|O1|Outcome|Presumed CTE Group|"Interventions administered to the Presumed CTE Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
62811|NCT02191267|E3|Reported Event|AD Dementia Group|"Interventions administered to the AD Dementia Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
62812|NCT02191267|E2|Reported Event|Control Group|"Interventions administered to the Control Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
62813|NCT02191267|E1|Reported Event|Presumed CTE Group|"Interventions administered to the Presumed CTE Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
62814|NCT02191137|B1|Baseline|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62815|NCT02191137|P1|Participant Flow|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62816|NCT02191137|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62817|NCT02191137|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62818|NCT02191137|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62819|NCT02191137|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62820|NCT02191137|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62849|NCT02191046|E2|Reported Event|Squeezable Bottle|record adverse event at baseline and daily adverse events until 2 weeks after treatment
62850|NCT02191046|E1|Reported Event|Syringe 20 ml|record adverse event at baseline and daily adverse events until 2 weeks after treatment
62821|NCT02191137|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62822|NCT02191137|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62823|NCT02191137|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62824|NCT02191137|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62825|NCT02191137|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62826|NCT02191137|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62827|NCT02191137|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62828|NCT02191137|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62829|NCT02191137|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62830|NCT02191137|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62831|NCT02191137|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62851|NCT02191033|B3|Baseline|Total|Total of all reporting groups
62852|NCT02191033|B2|Baseline|Standard of Care|"Smoking counseling, nicotine patch~Smoking counseling~Nicotine patch"
62853|NCT02191033|B1|Baseline|Text Messaging|"Smoking counseling, nicotine patch, text messaging~Smoking counseling~Text messaging~Nicotine patch"
63088|NCT02190604|E2|Reported Event|Part 1 QBW251 10mg|Part 1 QBW251 10mg
62832|NCT02191137|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62833|NCT02191137|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62834|NCT02191137|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62835|NCT02191137|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62836|NCT02191137|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62837|NCT02191137|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62838|NCT02191137|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62839|NCT02191137|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62840|NCT02191137|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62841|NCT02191137|E1|Reported Event|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
62842|NCT02191046|B3|Baseline|Total|Total of all reporting groups
62843|NCT02191046|B2|Baseline|Squeezable Bottle|"nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge~squeezable bottle: nasal irrigation twice daily for 2 weeks period"
62844|NCT02191046|B1|Baseline|Syringe 20 ml|"nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge~syringe 20 ml: nasal irrigation twice daily for 2 weeks period"
62845|NCT02191046|P2|Participant Flow|Squeezable Bottle|"nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge~squeezable bottle: nasal irrigation twice daily for 2 weeks period"
62846|NCT02191046|P1|Participant Flow|Syringe 20 ml|"nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge~syringe 20 ml: nasal irrigation twice daily for 2 weeks period"
63089|NCT02190604|E1|Reported Event|Part 1 Placebo|Part 1 Placebo
62857|NCT02191033|O1|Outcome|Text Messaging|"Smoking counseling, nicotine patch, text messaging~Smoking counseling~Nicotine patch~Text messaging"
62858|NCT02191033|O2|Outcome|Standard of Care|"Smoking counseling, nicotine patch~Smoking counseling~Nicotine patch"
62859|NCT02191033|O1|Outcome|Text Messaging|"Smoking counseling, nicotine patch, text messaging~Smoking counseling~Nicotine patch~Text messaging"
62860|NCT02191033|O2|Outcome|Standard of Care|"Smoking counseling, nicotine patch~Smoking counseling~Nicotine patch"
62861|NCT02191033|O1|Outcome|Text Messaging|"Smoking counseling, nicotine patch, text messaging~Smoking counseling~Nicotine patch~Text messaging"
62862|NCT02191033|E2|Reported Event|Standard of Care|"Smoking counseling, nicotine patch~Smoking counseling~Nicotine patch"
62863|NCT02191033|E1|Reported Event|Text Messaging|"Smoking counseling, nicotine patch, text messaging~Smoking counseling~Nicotine patch~Text messaging"
62864|NCT02190604|B20|Baseline|Total|Total of all reporting groups
62865|NCT02190604|B19|Baseline|Part 3 Placebo|Placebo to QBW251 in all cohorts of part 3 in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
62866|NCT02190604|B18|Baseline|Part 3 Cohort 3: QBW251|450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
62867|NCT02190604|B17|Baseline|Part 3 Cohort 2: QBW251|450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
62868|NCT02190604|B16|Baseline|Part 3 Cohort 1: QBW251|150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
62869|NCT02190604|B15|Baseline|Part 2 Placebo|Placebo to QBW251 in all cohorts of part 2 in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62870|NCT02190604|B14|Baseline|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62871|NCT02190604|B13|Baseline|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62872|NCT02190604|B12|Baseline|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62873|NCT02190604|B11|Baseline|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62874|NCT02190604|B10|Baseline|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62875|NCT02190604|B9|Baseline|Part 1 Placebo|Placebo to QBW251 in all cohorts of part 1 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62876|NCT02190604|B8|Baseline|Part 1 Cohort 8: QBW251|Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62877|NCT02190604|B7|Baseline|Part 1 Cohort 7: QBW251|Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62878|NCT02190604|B6|Baseline|Part 1 Cohort 6: QBW251 (Fastin / Fed), Same Subjects|Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62879|NCT02190604|B5|Baseline|Part 1 Cohort 6: QBW251|Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62880|NCT02190604|B4|Baseline|Part 1 Cohort 4: QBW251|Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62881|NCT02190604|B3|Baseline|Part 1 Cohort 3: QBW251|Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62882|NCT02190604|B2|Baseline|Part 1 Cohort 2: QBW251|Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62883|NCT02190604|B1|Baseline|Part 1 Cohort 1: QBW251|Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62884|NCT02190604|P19|Participant Flow|Part 3 Placebo|Placebo to QBW251 in all cohorts of part 3 in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
63090|NCT02190591|B3|Baseline|Total|Total of all reporting groups
62885|NCT02190604|P18|Participant Flow|Part 3 Cohort 3: QBW251|450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
62886|NCT02190604|P17|Participant Flow|Part 3 Cohort 2: QBW251|450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
62887|NCT02190604|P16|Participant Flow|Part 3 Cohort 1: QBW251|150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
62888|NCT02190604|P15|Participant Flow|Part 2 Placebo|Placebo to QBW251 in all cohorts of part 2 in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62889|NCT02190604|P14|Participant Flow|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62890|NCT02190604|P13|Participant Flow|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62891|NCT02190604|P12|Participant Flow|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62892|NCT02190604|P11|Participant Flow|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62893|NCT02190604|P10|Participant Flow|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62894|NCT02190604|P9|Participant Flow|Part 1 Placebo|Placebo to QBW251 in all cohorts of part 1 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62895|NCT02190604|P8|Participant Flow|Part 1 Cohort 8: QBW251|Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62896|NCT02190604|P7|Participant Flow|Part 1 Cohort 7: QBW251|Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62897|NCT02190604|P6|Participant Flow|Part 1 Cohort 6: QBW251 (Fasting/Fed), Same Subjects|Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62898|NCT02190604|P5|Participant Flow|Part 1 Cohort 5: QBW251|Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62899|NCT02190604|P4|Participant Flow|Part 1 Cohort 4: QBW251|Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62900|NCT02190604|P3|Participant Flow|Part 1 Cohort 3: QBW251|Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62901|NCT02190604|P2|Participant Flow|Part 1 Cohort 2: QBW251|Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62902|NCT02190604|P1|Participant Flow|Part 1 Cohort 1: QBW251|Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62903|NCT02190604|O5|Outcome|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62904|NCT02190604|O4|Outcome|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62905|NCT02190604|O3|Outcome|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62906|NCT02190604|O2|Outcome|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62907|NCT02190604|O1|Outcome|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62908|NCT02190604|O6|Outcome|Part 2 Placebo|Placebo to QBW251 in all cohorts of part 2 in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62909|NCT02190604|O5|Outcome|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62910|NCT02190604|O4|Outcome|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62911|NCT02190604|O3|Outcome|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62912|NCT02190604|O2|Outcome|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62913|NCT02190604|O1|Outcome|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62914|NCT02190604|O3|Outcome|Part 3 Cohort 3: QBW251|450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
62915|NCT02190604|O2|Outcome|Part 3 Cohort 2: QBW251|450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
62916|NCT02190604|O1|Outcome|Part 3 Cohort 1: QBW251|150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
62917|NCT02190604|O3|Outcome|Part 3 Cohort 3: QBW251|450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
62918|NCT02190604|O2|Outcome|Part 3 Cohort 2: QBW251|450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
62919|NCT02190604|O1|Outcome|Part 3 Cohort 1: QBW251|150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
62920|NCT02190604|O3|Outcome|Part 3 Cohort 3: QBW251|450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
62921|NCT02190604|O2|Outcome|Part 3 Cohort 2: QBW251|450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
62922|NCT02190604|O1|Outcome|Part 3 Cohort 1: QBW251|150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
62923|NCT02190604|O3|Outcome|Part 3 Cohort 3: QBW251|450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
62924|NCT02190604|O2|Outcome|Part 3 Cohort 2: QBW251|450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
62925|NCT02190604|O1|Outcome|Part 3 Cohort 1: QBW251|150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
62926|NCT02190604|O3|Outcome|Part 3 Cohort 3: QBW251|450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
62927|NCT02190604|O2|Outcome|Part 3 Cohort 2: QBW251|450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
62928|NCT02190604|O1|Outcome|Part 3 Cohort 1: QBW251|150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
62929|NCT02190604|O5|Outcome|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62930|NCT02190604|O4|Outcome|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62931|NCT02190604|O3|Outcome|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62932|NCT02190604|O2|Outcome|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62933|NCT02190604|O1|Outcome|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62934|NCT02190604|O5|Outcome|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62935|NCT02190604|O4|Outcome|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
63091|NCT02190591|B2|Baseline|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement~Peanut Labor Ball: Peanut Labor Ball"
62936|NCT02190604|O3|Outcome|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62937|NCT02190604|O2|Outcome|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62938|NCT02190604|O1|Outcome|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62939|NCT02190604|O5|Outcome|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62940|NCT02190604|O4|Outcome|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62941|NCT02190604|O3|Outcome|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62942|NCT02190604|O2|Outcome|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62943|NCT02190604|O1|Outcome|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62944|NCT02190604|O5|Outcome|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62945|NCT02190604|O4|Outcome|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62946|NCT02190604|O3|Outcome|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62947|NCT02190604|O2|Outcome|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62948|NCT02190604|O1|Outcome|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62949|NCT02190604|O5|Outcome|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62950|NCT02190604|O4|Outcome|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62951|NCT02190604|O3|Outcome|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62952|NCT02190604|O2|Outcome|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62953|NCT02190604|O1|Outcome|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62954|NCT02190604|O6|Outcome|Part 2 Placebo|Placebo to QBW251 in all cohorts of part 2 in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62955|NCT02190604|O5|Outcome|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62956|NCT02190604|O4|Outcome|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62957|NCT02190604|O3|Outcome|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62958|NCT02190604|O2|Outcome|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62959|NCT02190604|O1|Outcome|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62960|NCT02190604|O5|Outcome|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62961|NCT02190604|O4|Outcome|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62962|NCT02190604|O3|Outcome|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62963|NCT02190604|O2|Outcome|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62964|NCT02190604|O1|Outcome|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62965|NCT02190604|O5|Outcome|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62966|NCT02190604|O4|Outcome|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62967|NCT02190604|O3|Outcome|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62968|NCT02190604|O2|Outcome|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62969|NCT02190604|O1|Outcome|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62970|NCT02190604|O5|Outcome|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62971|NCT02190604|O4|Outcome|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62972|NCT02190604|O3|Outcome|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62973|NCT02190604|O2|Outcome|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62974|NCT02190604|O1|Outcome|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
62975|NCT02190604|O9|Outcome|Part 1 Cohort 8: QBW251|Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62976|NCT02190604|O8|Outcome|Part 1 Cohort 7: QBW251|Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62977|NCT02190604|O7|Outcome|Part 1 Cohort 6: QBW251(Fed)|Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62978|NCT02190604|O6|Outcome|Part 1 Cohort 6: QBW251|Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62979|NCT02190604|O5|Outcome|Part 1 Cohort 5: QBW251|Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62980|NCT02190604|O4|Outcome|Part 1 Cohort 4: QBW251|Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62981|NCT02190604|O3|Outcome|Part 1 Cohort 3: QBW251|Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62982|NCT02190604|O2|Outcome|Part 1 Cohort 2: QBW251|Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62983|NCT02190604|O1|Outcome|Part 1 Cohort 1: QBW251|Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62984|NCT02190604|O9|Outcome|Part 1 Cohort 8: QBW251|Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62985|NCT02190604|O8|Outcome|Part 1 Cohort 7: QBW251|Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62986|NCT02190604|O7|Outcome|Part 1 Cohort 6: QBW251(Fed)|Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62987|NCT02190604|O6|Outcome|Part 1 Cohort 6: QBW251|Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62988|NCT02190604|O5|Outcome|Part 1 Cohort 5: QBW251|Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62989|NCT02190604|O4|Outcome|Part 1 Cohort 4: QBW251|Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63092|NCT02190591|B1|Baseline|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
64342|NCT02178059|O1|Outcome|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation
62990|NCT02190604|O3|Outcome|Part 1 Cohort 3: QBW251|Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62991|NCT02190604|O2|Outcome|Part 1 Cohort 2: QBW251|Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62992|NCT02190604|O1|Outcome|Part 1 Cohort 1: QBW251|Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62993|NCT02190604|O9|Outcome|Part 1 Cohort 8: QBW251|Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62994|NCT02190604|O8|Outcome|Part 1 Cohort 7: QBW251|Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62995|NCT02190604|O7|Outcome|Part 1 Cohort 6: QBW251(Fed)|Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62996|NCT02190604|O6|Outcome|Part 1 Cohort 6: QBW251|Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62997|NCT02190604|O5|Outcome|Part 1 Cohort 5: QBW251|Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62998|NCT02190604|O4|Outcome|Part 1 Cohort 4: QBW251|Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
62999|NCT02190604|O3|Outcome|Part 1 Cohort 3: QBW251|Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63000|NCT02190604|O2|Outcome|Part 1 Cohort 2: QBW251|Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63001|NCT02190604|O1|Outcome|Part 1 Cohort 1: QBW251|Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63002|NCT02190604|O9|Outcome|Part 1 Cohort 8: QBW251|Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63003|NCT02190604|O8|Outcome|Part 1 Cohort 7: QBW251|Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63004|NCT02190604|O7|Outcome|Part 1 Cohort 6: QBW251(Fed)|Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63005|NCT02190604|O6|Outcome|Part 1 Cohort 6: QBW251|Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63006|NCT02190604|O5|Outcome|Part 1 Cohort 5: QBW251|Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63007|NCT02190604|O4|Outcome|Part 1 Cohort 4: QBW251|Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63008|NCT02190604|O3|Outcome|Part 1 Cohort 3: QBW251|Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63009|NCT02190604|O2|Outcome|Part 1 Cohort 2: QBW251|Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
64343|NCT02178059|O2|Outcome|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation
63010|NCT02190604|O1|Outcome|Part 1 Cohort 1: QBW251|Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63011|NCT02190604|O9|Outcome|Part 1 Cohort 8: QBW251|Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63012|NCT02190604|O8|Outcome|Part 1 Cohort 7: QBW251|Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63013|NCT02190604|O7|Outcome|Part 1 Cohort 6: QBW251(Fed)|Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63014|NCT02190604|O6|Outcome|Part 1 Cohort 6: QBW251|Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63015|NCT02190604|O5|Outcome|Part 1 Cohort 5: QBW251|Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63016|NCT02190604|O4|Outcome|Part 1 Cohort 4: QBW251|Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63017|NCT02190604|O3|Outcome|Part 1 Cohort 3: QBW251|Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63018|NCT02190604|O2|Outcome|Part 1 Cohort 2: QBW251|Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63019|NCT02190604|O1|Outcome|Part 1 Cohort 1: QBW251|Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63020|NCT02190604|O9|Outcome|Part 1 Cohort 8: QBW251|Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63021|NCT02190604|O8|Outcome|Part 1 Cohort 7: QBW251|Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63022|NCT02190604|O7|Outcome|Part 1 Cohort 6: QBW251(Fed)|Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63023|NCT02190604|O6|Outcome|Part 1 Cohort 6: QBW251|Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63024|NCT02190604|O5|Outcome|Part 1 Cohort 5: QBW251|Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63025|NCT02190604|O4|Outcome|Part 1 Cohort 4: QBW251|Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63026|NCT02190604|O3|Outcome|Part 1 Cohort 3: QBW251|Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63027|NCT02190604|O2|Outcome|Part 1 Cohort 2: QBW251|Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63028|NCT02190604|O1|Outcome|Part 1 Cohort 1: QBW251|Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63029|NCT02190604|O10|Outcome|Part 1 Placebo|Placebo to QBW251 in all cohorts of part 1 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
64344|NCT02178059|O1|Outcome|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation
63030|NCT02190604|O9|Outcome|Part 1 Cohort 8: QBW251|Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63031|NCT02190604|O8|Outcome|Part 1 Cohort 7: QBW251|Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63032|NCT02190604|O7|Outcome|Part 1 Cohort 6: QBW251(Fed)|Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63033|NCT02190604|O6|Outcome|Part 1 Cohort 6: QBW251|Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63034|NCT02190604|O5|Outcome|Part 1 Cohort 5: QBW251|Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63035|NCT02190604|O4|Outcome|Part 1 Cohort 4: QBW251|Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63036|NCT02190604|O3|Outcome|Part 1 Cohort 3: QBW251|Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63037|NCT02190604|O2|Outcome|Part 1 Cohort 2: QBW251|Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63038|NCT02190604|O1|Outcome|Part 1 Cohort 1: QBW251|Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63039|NCT02190604|O4|Outcome|Part 3 Placebo|Placebo to QBW251 in all cohorts of part 3 in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
63040|NCT02190604|O3|Outcome|Part 3 Cohort 3: QBW251|450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
63041|NCT02190604|O2|Outcome|Part 3 Cohort 2: QBW251|450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
63042|NCT02190604|O1|Outcome|Part 3 Cohort 1: QBW251|150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
63043|NCT02190604|O4|Outcome|Part 3 Placebo|Placebo to QBW251 in all cohorts of part 3 in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
63044|NCT02190604|O3|Outcome|Part 3 Cohort 3: QBW251|450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
63045|NCT02190604|O2|Outcome|Part 3 Cohort 2: QBW251|450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
63046|NCT02190604|O1|Outcome|Part 3 Cohort 1: QBW251|150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
63047|NCT02190604|O4|Outcome|Part 3 Placebo|Placebo to QBW251 in all cohorts of part 3 in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
63048|NCT02190604|O3|Outcome|Part 3 Cohort 3: QBW251|450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
63049|NCT02190604|O2|Outcome|Part 3 Cohort 2: QBW251|450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
63050|NCT02190604|O1|Outcome|Part 3 Cohort 1: QBW251|150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
63051|NCT02190604|O4|Outcome|Part 3 Placebo|Placebo to QBW251 in all cohorts of part 3 in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
63052|NCT02190604|O3|Outcome|Part 3 Cohort 3: QBW251|450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
64345|NCT02178059|O2|Outcome|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation
63053|NCT02190604|O2|Outcome|Part 3 Cohort 2: QBW251|450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
63054|NCT02190604|O1|Outcome|Part 3 Cohort 1: QBW251|150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
63055|NCT02190604|O16|Outcome|Part 1 Cohort 3: QBW251|Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63056|NCT02190604|O15|Outcome|Part 1 Cohort 2: QBW251|Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63057|NCT02190604|O14|Outcome|Part 1 Cohort 1: QBW251|Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15
63058|NCT02190604|O13|Outcome|Part 2 Placebo|Placebo to QBW251 in all cohorts of part 2 in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
63059|NCT02190604|O12|Outcome|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
63060|NCT02190604|O11|Outcome|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
63061|NCT02190604|O10|Outcome|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
63062|NCT02190604|O9|Outcome|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
63063|NCT02190604|O8|Outcome|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
63064|NCT02190604|O7|Outcome|Part 1 Placebo|Placebo to QBW251 in all cohorts of part 1 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63065|NCT02190604|O6|Outcome|Part 1 Cohort 8: QBW251|Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63066|NCT02190604|O5|Outcome|Part 1 Cohort 7: QBW251|Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63067|NCT02190604|O4|Outcome|Part 1 Cohort 6: QBW251(Fed)|Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63068|NCT02190604|O3|Outcome|Part 1 Cohort 6: QBW251|Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63069|NCT02190604|O2|Outcome|Part 1 Cohort 5: QBW251|Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63070|NCT02190604|O1|Outcome|Part 1 Cohort 4: QBW251|Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
63071|NCT02190604|E19|Reported Event|Part 3 QBW251 450mg BID C3|Part 3 QBW251 450mg BID C3
63072|NCT02190604|E18|Reported Event|Part 3 QBW251 450mg BID C2|Part 3 QBW251 450mg BID C2
63073|NCT02190604|E17|Reported Event|Part 3 QBW251 150mg BID C1|Part 3 QBW251 150mg BID C1
63074|NCT02190604|E16|Reported Event|Part 3 Placebo C1/C2/C3|Part 3 Placebo C1/C2/C3
63075|NCT02190604|E15|Reported Event|Part 2 QBW251 750mg BID|Part 2 QBW251 750mg BID
63076|NCT02190604|E14|Reported Event|Part 2 QBW251 450mg BID|Part 2 QBW251 450mg BID
63077|NCT02190604|E13|Reported Event|Part 2 QBW251 750mg|Part 2 QBW251 750mg
63078|NCT02190604|E12|Reported Event|Part 2 QBW251 400mg|Part 2 QBW251 400mg
63079|NCT02190604|E11|Reported Event|Part 2 QBW251 150mg|Part 2 QBW251 150mg
63080|NCT02190604|E10|Reported Event|Part 2 Placebo|Part 2 Placebo
63081|NCT02190604|E9|Reported Event|Part 1 QBW251 1000mg|Part 1 QBW251 1000mg
63082|NCT02190604|E8|Reported Event|Part 1 QBW251 750mg|Part 1 QBW251 750mg
63083|NCT02190604|E7|Reported Event|Part 1 QBW251 500mg (Fed)|Part 1 QBW251 500mg (fed)
63084|NCT02190604|E6|Reported Event|Part 1 QBW251 500mg|Part 1 QBW251 500mg
63085|NCT02190604|E5|Reported Event|Part 1 QBW251 300mg|Part 1 QBW251 300mg
63086|NCT02190604|E4|Reported Event|Part 1 QBW251 150mg|Part 1 QBW251 150mg
63087|NCT02190604|E3|Reported Event|Part 1 QBW251 25mg|Part 1 QBW251 25mg
63093|NCT02190591|P2|Participant Flow|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement~Peanut Labor Ball: Peanut Labor Ball"
63094|NCT02190591|P1|Participant Flow|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
63095|NCT02190591|O2|Outcome|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement~Peanut Labor Ball: Peanut Labor Ball"
63096|NCT02190591|O1|Outcome|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
63097|NCT02190591|O2|Outcome|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement~Peanut Labor Ball: Peanut Labor Ball"
63098|NCT02190591|O1|Outcome|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
63099|NCT02190591|O2|Outcome|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement~Peanut Labor Ball: Peanut Labor Ball"
63100|NCT02190591|O1|Outcome|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
63101|NCT02190591|E2|Reported Event|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement~Peanut Labor Ball: Peanut Labor Ball"
63102|NCT02190591|E1|Reported Event|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
63103|NCT02190435|B3|Baseline|Total|Total of all reporting groups
63104|NCT02190435|B2|Baseline|Control|Patients that receive intramedullary nail fixation without use of the ADAPT system
63105|NCT02190435|B1|Baseline|ADAPT|"Patients that receive intramedullary nail fixation with use of the ADAPT system~Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3"
63106|NCT02190435|P2|Participant Flow|Control|Patients that receive intramedullary nail fixation without use of the ADAPT system
63107|NCT02190435|P1|Participant Flow|ADAPT|"Patients that receive intramedullary nail fixation with use of the ADAPT system~Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3"
63108|NCT02190435|O2|Outcome|Control|Patients that receive intramedullary nail fixation without use of the ADAPT system
63109|NCT02190435|O1|Outcome|ADAPT|"Patients that receive intramedullary nail fixation with use of the ADAPT system~Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3"
63110|NCT02190435|O2|Outcome|Control|Patients that receive intramedullary nail fixation without use of the ADAPT system
63111|NCT02190435|O1|Outcome|ADAPT|"Patients that receive intramedullary nail fixation with use of the ADAPT system~Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3"
63112|NCT02190435|E2|Reported Event|Control|Patients that receive intramedullary nail fixation without use of the ADAPT system
63113|NCT02190435|E1|Reported Event|ADAPT|"Patients that receive intramedullary nail fixation with use of the ADAPT system~Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3"
63114|NCT02189954|B3|Baseline|Total|Total of all reporting groups
63115|NCT02189954|B2|Baseline|Group Pressure Limiting|"Cuff inner pressure was held below 44 mmHg~Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group PL, n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)"
63116|NCT02189954|B1|Baseline|Group Routine Care|"The placement according to the manufacturer's instructions.~The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience"
63117|NCT02189954|P2|Participant Flow|Group Pressure Limiting|"Cuff inner pressure was held below 44 mmHg~Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group Pressure Limiting (PL)), n=45) cuff inner pressure was held below 60 centimeter of water (cmH2O) (44 mmHg)"
63118|NCT02189954|P1|Participant Flow|Group Routine Care|"The placement according to the manufacturer's instructions.~The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique® (LMU) was lubricated with a water-based gel and the cuff was completely deflated. After induction when bispectral index (BIS) values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience"
63119|NCT02189954|O2|Outcome|Group Pressure Limiting|"Cuff inner pressure was held below 44 mmHg~Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group PL, n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)"
63120|NCT02189954|O1|Outcome|Group Routine Care|"The placement according to the manufacturer's instructions.~The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience"
63121|NCT02189954|O2|Outcome|Group Pressure Limiting|"Cuff inner pressure was held below 44 mmHg~Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group PL, n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)"
63122|NCT02189954|O1|Outcome|Group Routine Care|"The placement according to the manufacturer's instructions.~The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience"
63123|NCT02189954|E2|Reported Event|Group Pressure Limiting|"Cuff inner pressure was held below 44 mmHg~Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group PL, n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)"
63152|NCT02189915|O1|Outcome|Creatine Monohydrate Treatment|This study is an open label study, where all participants received Creatine monohydrate.
63124|NCT02189954|E1|Reported Event|Group Routine Care|"The placement according to the manufacturer's instructions.~The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience"
63125|NCT02189941|B1|Baseline|Healthy Volunteers|Subjects received one dose of deferiprone sustained-release tablets under fed conditions, one dose of deferiprone sustained-release tablets under fasting conditions, and one dose of deferiprone immediate-release tablets under fasting conditions, 7 days apart
63126|NCT02189941|P3|Participant Flow|Ferriprox Fasting, Then DFP-SR Fed, Then DFP-SR Fasting|"Subjects received 3 treatments in the following order, with a 7-day washout period between treatments:~One dose of Ferriprox immediate-release tablets under fasting conditions~One dose of deferiprone sustained-release tablets under fed conditions~One dose of deferiprone sustained-release tablets under fasting conditions"
63127|NCT02189941|P2|Participant Flow|DFP-SR Fasting, Then Ferriprox Fasting, Then DFP-SR Fed|"Subjects received 3 treatments in the following order, with a 7-day washout period between treatments:~One dose of deferiprone sustained-release tablets under fasting conditions~One dose of Ferriprox immediate-release tablets under fasting conditions~One dose of deferiprone sustained-release tablets under fed conditions"
63128|NCT02189941|P1|Participant Flow|DFP-SR Fed, Then DFP-SR Fasting, Then Ferriprox Fasting|"Subjects received 3 treatments in the following order, with a 7-day washout period between treatments:~One dose of deferiprone sustained-release (DFP-SR) tablets under fed conditions~One dose of deferiprone sustained-release tablets under fasting conditions~One dose of Ferriprox immediate-release (IR) tablets under fasting conditions"
63129|NCT02189941|O3|Outcome|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.~Deferiprone immediate-release: Deferiprone immediate-release tablets"
63130|NCT02189941|O2|Outcome|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
63131|NCT02189941|O1|Outcome|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
63132|NCT02189941|O3|Outcome|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.~Deferiprone immediate-release: Deferiprone immediate-release tablets"
63133|NCT02189941|O2|Outcome|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
63134|NCT02189941|O1|Outcome|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
63135|NCT02189941|O3|Outcome|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.~Deferiprone immediate-release: Deferiprone immediate-release tablets"
63136|NCT02189941|O2|Outcome|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
63137|NCT02189941|O1|Outcome|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
63138|NCT02189941|O3|Outcome|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.~Deferiprone immediate-release: Deferiprone immediate-release tablets"
63139|NCT02189941|O2|Outcome|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
63140|NCT02189941|O1|Outcome|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
63141|NCT02189941|O3|Outcome|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.~Deferiprone immediate-release: Deferiprone immediate-release tablets"
63142|NCT02189941|O2|Outcome|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
63143|NCT02189941|O1|Outcome|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
63144|NCT02189941|O3|Outcome|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.~Deferiprone immediate-release: Deferiprone immediate-release tablets"
63145|NCT02189941|O2|Outcome|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
63146|NCT02189941|O1|Outcome|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
63147|NCT02189941|E3|Reported Event|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.~Deferiprone immediate-release: Deferiprone immediate-release tablets"
63148|NCT02189941|E2|Reported Event|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
63149|NCT02189941|E1|Reported Event|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
63150|NCT02189915|B1|Baseline|Creatine Monohydrate|Creatine monohydrate
63151|NCT02189915|P1|Participant Flow|Creatine Monohydrate Treatment|This study is an open label study, where all participants received Creatine monohydrate.
63153|NCT02189915|O1|Outcome|Creatine Monohydrate Treatment|This study is an open label study, where all participants received Creatine monohydrate.
63154|NCT02189915|E1|Reported Event|Creatine Monohydrate Treatment|This study is an open label study, where all participants received Creatine monohydrate.
63155|NCT02189863|B1|Baseline|Overall|Lotrafilcon B MV and lotrafilcon B MF contact lenses worn in Period 1 and Period 2, as randomized
63156|NCT02189863|P2|Participant Flow|AOAMF, Then AOAMV|Lotrafilcon B MF contact lenses worn for 2 weeks in Period 1, followed by lotrafilcon B MV contact lenses worn for 2 weeks in Period 2
63157|NCT02189863|P1|Participant Flow|AOAMV, Then AOAMF|Lotrafilcon B MV contact lenses (AOAMV) worn for 2 weeks in Period 1, followed by lotrafilcon B MF contact lenses (AOAMF) worn for 2 weeks in Period 2
63158|NCT02189863|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn in both eyes for 2 weeks
63159|NCT02189863|O1|Outcome|AOAMV|Lotrafilcon B spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near for 2 weeks
63160|NCT02189863|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn in both eyes for 2 weeks
63161|NCT02189863|O1|Outcome|AOAMV|Lotrafilcon B spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near for 2 weeks
63162|NCT02189863|E5|Reported Event|Habitual|Contact lenses worn in both eyes per subject's habitual prescription on Day 1, Period 1, for a same-day assessment
63163|NCT02189863|E4|Reported Event|Biofinity MF|Comfilcon A multifocal contact lenses worn in both eyes during Period 2 for a same-day assessment
63164|NCT02189863|E3|Reported Event|Lotra B SVD|Lotrafilcon B spherical contact lenses worn with both eyes corrected for distance during Period 1 for a same-day assessment
63165|NCT02189863|E2|Reported Event|AOAMF|Lotrafilcon B multifocal contact lenses worn in both eyes for 2 weeks
63166|NCT02189863|E1|Reported Event|AOAMV|Lotrafilcon B spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near for 2 weeks
63167|NCT02189837|B5|Baseline|Total|Total of all reporting groups
63168|NCT02189837|B4|Baseline|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
63169|NCT02189837|B3|Baseline|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
63170|NCT02189837|B2|Baseline|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
63171|NCT02189837|B1|Baseline|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
63172|NCT02189837|P4|Participant Flow|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
63173|NCT02189837|P3|Participant Flow|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
63174|NCT02189837|P2|Participant Flow|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
63175|NCT02189837|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
63176|NCT02189837|O4|Outcome|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
63177|NCT02189837|O3|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
63178|NCT02189837|O2|Outcome|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
63179|NCT02189837|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
63180|NCT02189837|O4|Outcome|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
63181|NCT02189837|O3|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
63182|NCT02189837|O2|Outcome|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
63183|NCT02189837|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
63184|NCT02189837|O4|Outcome|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
63185|NCT02189837|O3|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
63186|NCT02189837|O2|Outcome|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
63187|NCT02189837|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
63188|NCT02189837|O4|Outcome|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
63189|NCT02189837|O3|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
63190|NCT02189837|O2|Outcome|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
63191|NCT02189837|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
63192|NCT02189837|O4|Outcome|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
63193|NCT02189837|O3|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
63194|NCT02189837|O2|Outcome|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
63195|NCT02189837|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
63196|NCT02189837|E4|Reported Event|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
63197|NCT02189837|E3|Reported Event|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
63198|NCT02189837|E2|Reported Event|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
63199|NCT02189837|E1|Reported Event|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
63200|NCT02189759|B5|Baseline|Total|Total of all reporting groups
63201|NCT02189759|B4|Baseline|Standard Kangaroo Mother Care to Discharge|Standard Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), standard treatment will be given which may include remova
63202|NCT02189759|B3|Baseline|Continuous Kangaroo Mother Care to Discharge|Continuous Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the
63203|NCT02189759|B2|Baseline|Standard Kangaroo Mother Care to One Hour After Birth|Standard Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant bec
63204|NCT02189759|B1|Baseline|Continuous Kangaroo Mother Care to One Hour After Birth|Continuous Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-in
63205|NCT02189759|P4|Participant Flow|Standard Kangaroo Mother Care to Discharge|Standard Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), standard treatment will be given which may include remova
63206|NCT02189759|P3|Participant Flow|Continuous Kangaroo Mother Care to Discharge|Continuous Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the
63207|NCT02189759|P2|Participant Flow|Standard Kangaroo Mother Care to One Hour After Birth|Standard Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant bec
63208|NCT02189759|P1|Participant Flow|Continuous Kangaroo Mother Care to One Hour After Birth|Continuous Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-in
63242|NCT02189317|O1|Outcome|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
63209|NCT02189759|O4|Outcome|Standard Kangaroo Mother Care to Discharge|Standard Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), standard treatment will be given which may include remova
63210|NCT02189759|O3|Outcome|Continuous Kangaroo Mother Care to Discharge|Continuous Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the
63211|NCT02189759|O2|Outcome|Standard Kangaroo Mother Care to One Hour After Birth|Standard Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant bec
63212|NCT02189759|O1|Outcome|Continuous Kangaroo Mother Care to One Hour After Birth|Continuous Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-in
63213|NCT02189759|O4|Outcome|Standard Kangaroo Mother Care to Discharge|Standard Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), standard treatment will be given which may include remova
63214|NCT02189759|O3|Outcome|Continuous Kangaroo Mother Care to Discharge|Continuous Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the
63215|NCT02189759|O2|Outcome|Standard Kangaroo Mother Care to One Hour After Birth|Standard Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant bec
63216|NCT02189759|O1|Outcome|Continuous Kangaroo Mother Care to One Hour After Birth|Continuous Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-in
63217|NCT02189759|O2|Outcome|Standard Kangaroo Mother Care to Discharge|Standard Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), standard treatment will be given which may include remova
63218|NCT02189759|O1|Outcome|Continuous Kangaroo Mother Care to Discharge|Continuous Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the
63219|NCT02189759|O2|Outcome|Standard Kangaroo Mother Care to One Hour After Birth|Standard Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant bec
63220|NCT02189759|O1|Outcome|Continuous Kangaroo Mother Care to One Hour After Birth|Continuous Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-in
63221|NCT02189759|E4|Reported Event|Standard Kangaroo Mother Care to Discharge|Standard Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), standard treatment will be given which may include remova
63222|NCT02189759|E3|Reported Event|Continuous Kangaroo Mother Care to Discharge|Continuous Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the
63223|NCT02189759|E2|Reported Event|Standard Kangaroo Mother Care to One Hour After Birth|Standard Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant bec
63224|NCT02189759|E1|Reported Event|Continuous Kangaroo Mother Care to One Hour After Birth|Continuous Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-in
63225|NCT02189668|B3|Baseline|Total|Total of all reporting groups
63226|NCT02189668|B2|Baseline|Surgery|Usual care with urgent appendectomy
63227|NCT02189668|B1|Baseline|Non-operative|"Non-operative management with antibiotics alone Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic~Antibiotics only (Zosyn then Augmentin): Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic"
63228|NCT02189668|P2|Participant Flow|Surgery|Usual care with urgent appendectomy
63229|NCT02189668|P1|Participant Flow|Non-operative|"Non-operative management with antibiotics alone Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic~Antibiotics only (Zosyn then Augmentin): Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic"
63230|NCT02189668|O2|Outcome|Surgery|Usual care with urgent appendectomy
63231|NCT02189668|O1|Outcome|Non-operative|"Non-operative management with antibiotics alone Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic~Antibiotics only (Zosyn then Augmentin): Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic"
63232|NCT02189668|O2|Outcome|Surgery|Usual care with urgent appendectomy
63233|NCT02189668|O1|Outcome|Non-operative|"Non-operative management with antibiotics alone Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic~Antibiotics only (Zosyn then Augmentin): Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic"
63234|NCT02189668|E2|Reported Event|Surgery|Usual care with urgent appendectomy
63235|NCT02189668|E1|Reported Event|Non-operative|"Non-operative management with antibiotics alone Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic~Antibiotics only (Zosyn then Augmentin): Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic"
63236|NCT02189317|B3|Baseline|Total|Total of all reporting groups
63237|NCT02189317|B2|Baseline|Exparel (Liposomal Bupivacaine)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
63238|NCT02189317|B1|Baseline|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
63239|NCT02189317|P2|Participant Flow|Exparel (Bupivacaine Liposome)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
63240|NCT02189317|P1|Participant Flow|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
63241|NCT02189317|O2|Outcome|Exparel (Liposomal Bupivacaine)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
63331|NCT02188784|P2|Participant Flow|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks~Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
63243|NCT02189317|O2|Outcome|Exparel (Liposomal Bupivacaine)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
63244|NCT02189317|O1|Outcome|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
63245|NCT02189317|O2|Outcome|Exparel (Liposomal Bupivacaine)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
63246|NCT02189317|O1|Outcome|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
63247|NCT02189317|E2|Reported Event|Exparel (Bupivacaine Liposome)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
63248|NCT02189317|E1|Reported Event|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
63249|NCT02189252|B5|Baseline|Total|Total of all reporting groups
63250|NCT02189252|B4|Baseline|Treatment Sequence 4|Lovaza 4 g per day:Epanova 2 g per day: 4 subjects
63251|NCT02189252|B3|Baseline|Treatment Sequence 3|Epanova 2 g per day:Lovaza 4 g per day
63252|NCT02189252|B2|Baseline|Treatment Sequence 2|Lovaza 4 g per day:Epanova 4 g per day : 4 subjects
63253|NCT02189252|B1|Baseline|Treatment Sequence 1|Epanova 4 g per day:Lovaza 4 g per day
63254|NCT02189252|P4|Participant Flow|Treatment Sequence 4|Lovaza 4g per day:Epanova 2g per day:
63255|NCT02189252|P3|Participant Flow|Treatment Sequence 3|Epanova 2g per day:Lovaza 4g per day:
63256|NCT02189252|P2|Participant Flow|Treatment Sequence 2|Lovaza 4 g per day:Epanova 4 g per day : 4 subjects
63257|NCT02189252|P1|Participant Flow|Treatment Sequence 1|Epanova 4g per day: Lovaza 4g per day
63258|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
63259|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
63260|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
63261|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
63262|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
63263|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
63264|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
63265|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
63266|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
63267|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
63268|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
63269|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
63270|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
63271|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
63272|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
63273|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
63274|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
63275|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
63276|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
63277|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
63278|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
63279|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
63280|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
63281|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
63282|NCT02189252|E6|Reported Event|Lovaza 4 g (II)|Treatment period II
63283|NCT02189252|E5|Reported Event|Epanova 4 g (II)|Treatment period II
63284|NCT02189252|E4|Reported Event|Epanova 2 g (II)|Treatment period II
63285|NCT02189252|E3|Reported Event|Lovaza 4 g (I)|Treatment period I
63286|NCT02189252|E2|Reported Event|Epanova 4 g (I)|Treatment period I
63287|NCT02189252|E1|Reported Event|Epanova 2 g (I)|Treatment period I
63288|NCT02189161|B1|Baseline|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal~Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
63289|NCT02189161|P1|Participant Flow|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal~Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
63332|NCT02188784|P1|Participant Flow|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks~Polysaccharide Iron Complex 150 mg: Oral Iron"
63333|NCT02188784|O2|Outcome|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks~Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
63290|NCT02189161|O1|Outcome|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal~Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
63291|NCT02189161|O1|Outcome|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal~Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
63292|NCT02189161|O1|Outcome|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal~Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
63293|NCT02189161|E1|Reported Event|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal~Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
63294|NCT02189122|B3|Baseline|Total|Total of all reporting groups
63295|NCT02189122|B2|Baseline|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
63296|NCT02189122|B1|Baseline|Group 1:Aspirin/Placebo|"Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
63297|NCT02189122|P2|Participant Flow|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days.~Three subjects participated in each possible sequence with the following exceptions: Four subjects participated in the sequence NHP544C 81 mg, NHP544C 162 mg, placebo; two subjects participated in the sequence NHP544C 162 mg, placebo, NHP544C 81 mg."
63298|NCT02189122|P1|Participant Flow|Group 1:Aspirin/Placebo|"Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days.~Three subjects participated in each possible sequence with the following exceptions: Four subjects participated in the sequence Aspirin 81 mg, Aspirin 162.5 mg, placebo; two subjects participated in the sequence placebo, Aspirin 162.5 mg, Aspirin 81 mg."
63299|NCT02189122|O2|Outcome|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
63300|NCT02189122|O1|Outcome|Group 1:Aspirin/Placebo|"Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
63301|NCT02189122|O2|Outcome|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
63302|NCT02189122|O1|Outcome|Group 1:Aspirin/Placebo|"Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
63334|NCT02188784|O1|Outcome|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks~Polysaccharide Iron Complex 150 mg: Oral Iron"
64346|NCT02178059|O1|Outcome|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation
63303|NCT02189122|O2|Outcome|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
63304|NCT02189122|O1|Outcome|Group 1:Aspirin/Placebo|"Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
63305|NCT02189122|O2|Outcome|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
63306|NCT02189122|O1|Outcome|Group 1:Aspirin/Placebo|"Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
63307|NCT02189122|O2|Outcome|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
63308|NCT02189122|O1|Outcome|Group 1:Aspirin/Placebo|"Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
63309|NCT02189122|O2|Outcome|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
63310|NCT02189122|O1|Outcome|Group 1:Aspirin/Placebo|"Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
63311|NCT02189122|E2|Reported Event|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
63312|NCT02189122|E1|Reported Event|Group 1:Aspirin/Placebo|"Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
63313|NCT02188849|B3|Baseline|Total|Total of all reporting groups
63314|NCT02188849|B2|Baseline|Placebo|"Maltodextrin 5 g/day to be dissolved in water~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
63315|NCT02188849|B1|Baseline|Creatine|"Creatine 5 g/ day~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.~Creatine: Creatine powder 5 g day"
63335|NCT02188784|O2|Outcome|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks~Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
63336|NCT02188784|O1|Outcome|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks~Polysaccharide Iron Complex 150 mg: Oral Iron"
104925|NCT01955564|E3|Reported Event|Cohort 2|NW-3509a 2mg, single dose
63316|NCT02188849|P2|Participant Flow|Placebo|"Maltodextrin 5 g/day to be dissolved in water~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
63317|NCT02188849|P1|Participant Flow|Creatine|"Creatine 5 g/ day~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.~Creatine: Creatine powder 5 g day"
63318|NCT02188849|O2|Outcome|Placebo|"Maltodextrin 5 g/day to be dissolved in water~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
63319|NCT02188849|O1|Outcome|Creatine|"Creatine 5 g/ day~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.~Creatine: Creatine powder 5 g day"
63320|NCT02188849|O2|Outcome|Placebo|"Maltodextrin 5 g/day to be dissolved in water~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
63321|NCT02188849|O1|Outcome|Creatine|"Creatine 5 g/ day~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.~Creatine: Creatine powder 5 g day"
63322|NCT02188849|O2|Outcome|Placebo|"Maltodextrin 5 g/day to be dissolved in water~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
63323|NCT02188849|O1|Outcome|Creatine|"Creatine 5 g/ day~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.~Creatine: Creatine powder 5 g day"
63324|NCT02188849|O2|Outcome|Placebo|"Maltodextrin 5 g/day to be dissolved in water~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
63325|NCT02188849|O1|Outcome|Creatine|"Creatine 5 g/ day~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.~Creatine: Creatine powder 5 g day"
63326|NCT02188849|E2|Reported Event|Placebo|"Maltodextrin 5 g/day to be dissolved in water~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
63327|NCT02188849|E1|Reported Event|Creatine|"Creatine 5 g/ day~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.~Creatine: Creatine powder 5 g day"
63328|NCT02188784|B3|Baseline|Total|Total of all reporting groups
63329|NCT02188784|B2|Baseline|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks~Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
63330|NCT02188784|B1|Baseline|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks~Polysaccharide Iron Complex 150 mg: Oral Iron"
63337|NCT02188784|O2|Outcome|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks~Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
63338|NCT02188784|O1|Outcome|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks~Polysaccharide Iron Complex 150 mg: Oral Iron"
63339|NCT02188784|O2|Outcome|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks~Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
63340|NCT02188784|O1|Outcome|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks~Polysaccharide Iron Complex 150 mg: Oral Iron"
63341|NCT02188784|O2|Outcome|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks~Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
63342|NCT02188784|O1|Outcome|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks~Polysaccharide Iron Complex 150 mg: Oral Iron"
63343|NCT02188784|O2|Outcome|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks~Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
63344|NCT02188784|O1|Outcome|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks~Polysaccharide Iron Complex 150 mg: Oral Iron"
63345|NCT02188784|E2|Reported Event|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks~Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
63346|NCT02188784|E1|Reported Event|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks~Polysaccharide Iron Complex 150 mg: Oral Iron"
63347|NCT02188589|B1|Baseline|Treatment Group|Nasal implant: Treatment group may receive bilateral nasal implants (maximum of 4, 2 per side)
63348|NCT02188589|P1|Participant Flow|Treatment Group|Nasal implant: Treatment group may receive bilateral nasal implants (maximum of 4, 2 per side)
63349|NCT02188589|O1|Outcome|Treatment Group|Nasal implant: Treatment group may receive bilateral nasal implants (maximum of 4, 2 per side)
63350|NCT02188589|O1|Outcome|Treatment Group|Nasal implant: Treatment group may receive bilateral nasal implants (maximum of 4, 2 per side)
63351|NCT02188589|E1|Reported Event|Treatment Group|Nasal implant: Treatment group may receive bilateral nasal implants (maximum of 4, 2 per side)
63352|NCT02187887|B3|Baseline|Total|Total of all reporting groups
63353|NCT02187887|B2|Baseline|Control|Control participants receive feedback correcting their misperceptions of the video game playing behavior and attitudes of fellow veterans
63354|NCT02187887|B1|Baseline|Personalized Normative Feedback|"Intervention participants receive feedback correcting their misperceptions of the drinking behavior and attitudes of fellow veterans~Personalized normative feedback: Participants receive behavioral norms feedback based on their response to items in a baseline survey. Personal responses are presented along with perceptions of other same gender veterans and actual drinking norms of same gender veterans."
63355|NCT02187887|P2|Participant Flow|Control|Control participants receive feedback correcting their misperceptions of the video game playing behavior and attitudes of fellow veterans
63356|NCT02187887|P1|Participant Flow|Personalized Normative Feedback|"Intervention participants receive feedback correcting their misperceptions of the drinking behavior and attitudes of fellow veterans~Personalized normative feedback: Participants receive behavioral norms feedback based on their response to items in a baseline survey. Personal responses are presented along with perceptions of other same gender veterans and actual drinking norms of same gender veterans."
63357|NCT02187887|O2|Outcome|Control|Control participants receive feedback correcting their misperceptions of the video game playing behavior and attitudes of fellow veterans
63358|NCT02187887|O1|Outcome|Personalized Normative Feedback|"Intervention participants receive feedback correcting their misperceptions of the drinking behavior and attitudes of fellow veterans~Personalized normative feedback: Participants receive behavioral norms feedback based on their response to items in a baseline survey. Personal responses are presented along with perceptions of other same gender veterans and actual drinking norms of same gender veterans."
63359|NCT02187887|O2|Outcome|Control|Control participants receive feedback correcting their misperceptions of the video game playing behavior and attitudes of fellow veterans
63360|NCT02187887|O1|Outcome|Personalized Normative Feedback|"Intervention participants receive feedback correcting their misperceptions of the drinking behavior and attitudes of fellow veterans~Personalized normative feedback: Participants receive behavioral norms feedback based on their response to items in a baseline survey. Personal responses are presented along with perceptions of other same gender veterans and actual drinking norms of same gender veterans."
63361|NCT02187887|E2|Reported Event|Control|Control participants receive feedback correcting their misperceptions of the video game playing behavior and attitudes of fellow veterans
63362|NCT02187887|E1|Reported Event|Personalized Normative Feedback|"Intervention participants receive feedback correcting their misperceptions of the drinking behavior and attitudes of fellow veterans~Personalized normative feedback: Participants receive behavioral norms feedback based on their response to items in a baseline survey. Personal responses are presented along with perceptions of other same gender veterans and actual drinking norms of same gender veterans."
63363|NCT02187861|B5|Baseline|Total|Total of all reporting groups
63364|NCT02187861|B4|Baseline|Chemotherapy-Containing Cohort: Arm C (BR)|Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63365|NCT02187861|B3|Baseline|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63366|NCT02187861|B2|Baseline|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63475|NCT02187809|E1|Reported Event|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
63367|NCT02187861|B1|Baseline|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63368|NCT02187861|P4|Participant Flow|Chemotherapy-Containing Cohort: Arm C (BR)|Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63369|NCT02187861|P3|Participant Flow|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63370|NCT02187861|P2|Participant Flow|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63371|NCT02187861|P1|Participant Flow|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63372|NCT02187861|O3|Outcome|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63373|NCT02187861|O2|Outcome|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63374|NCT02187861|O1|Outcome|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63375|NCT02187861|O3|Outcome|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63376|NCT02187861|O2|Outcome|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63377|NCT02187861|O1|Outcome|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63378|NCT02187861|O3|Outcome|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63379|NCT02187861|O2|Outcome|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63380|NCT02187861|O1|Outcome|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63381|NCT02187861|O3|Outcome|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63382|NCT02187861|O2|Outcome|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63476|NCT02187744|B3|Baseline|Total|Total of all reporting groups
64347|NCT02178059|O2|Outcome|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation
63383|NCT02187861|O1|Outcome|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63384|NCT02187861|O3|Outcome|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63385|NCT02187861|O2|Outcome|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63386|NCT02187861|O1|Outcome|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63387|NCT02187861|O3|Outcome|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63388|NCT02187861|O2|Outcome|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63389|NCT02187861|O1|Outcome|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63390|NCT02187861|O4|Outcome|Chemotherapy-Containing Cohort: Arm C (BR)|Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63391|NCT02187861|O3|Outcome|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63392|NCT02187861|O2|Outcome|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63393|NCT02187861|O1|Outcome|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63394|NCT02187861|O4|Outcome|Chemotherapy-Containing Cohort: Arm C (BR)|Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63395|NCT02187861|O3|Outcome|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63396|NCT02187861|O2|Outcome|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63397|NCT02187861|O1|Outcome|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63398|NCT02187861|O4|Outcome|Chemotherapy-Containing Cohort: Arm C (BR)|Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63399|NCT02187861|O3|Outcome|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63400|NCT02187861|O2|Outcome|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63401|NCT02187861|O1|Outcome|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63402|NCT02187861|O4|Outcome|Chemotherapy-Containing Cohort: Arm C (BR)|Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63403|NCT02187861|O3|Outcome|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63404|NCT02187861|O2|Outcome|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63405|NCT02187861|O1|Outcome|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63406|NCT02187861|O4|Outcome|Chemotherapy-Containing Cohort: Arm C (BR)|Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63407|NCT02187861|O3|Outcome|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63408|NCT02187861|O2|Outcome|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63409|NCT02187861|O1|Outcome|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63410|NCT02187861|O4|Outcome|Chemotherapy-Containing Cohort: Arm C (BR)|Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63411|NCT02187861|O3|Outcome|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63412|NCT02187861|O2|Outcome|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63413|NCT02187861|O1|Outcome|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63414|NCT02187861|O4|Outcome|Chemotherapy-Containing Cohort: Arm C (BR)|Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63415|NCT02187861|O3|Outcome|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63416|NCT02187861|O2|Outcome|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63434|NCT02187861|O4|Outcome|Chemotherapy-Containing Cohort: Arm C (BR)|Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63477|NCT02187744|B2|Baseline|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
63417|NCT02187861|O1|Outcome|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63418|NCT02187861|O4|Outcome|Chemotherapy-Containing Cohort: Arm C (BR)|Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63419|NCT02187861|O3|Outcome|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63420|NCT02187861|O2|Outcome|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63421|NCT02187861|O1|Outcome|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63422|NCT02187861|O4|Outcome|Chemotherapy-Containing Cohort: Arm C (BR)|Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63423|NCT02187861|O3|Outcome|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63424|NCT02187861|O2|Outcome|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63425|NCT02187861|O1|Outcome|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63426|NCT02187861|O4|Outcome|Chemotherapy-Containing Cohort: Arm C (BR)|Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63427|NCT02187861|O3|Outcome|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63428|NCT02187861|O2|Outcome|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63429|NCT02187861|O1|Outcome|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63430|NCT02187861|O4|Outcome|Chemotherapy-Containing Cohort: Arm C (BR)|Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63431|NCT02187861|O3|Outcome|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63432|NCT02187861|O2|Outcome|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63433|NCT02187861|O1|Outcome|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
65323|NCT02171234|P4|Participant Flow|Group 3 - 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine 800mg
63435|NCT02187861|O3|Outcome|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63436|NCT02187861|O2|Outcome|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63437|NCT02187861|O1|Outcome|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63438|NCT02187861|O4|Outcome|Chemotherapy-Containing Cohort: Arm C (BR)|Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63439|NCT02187861|O3|Outcome|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63440|NCT02187861|O2|Outcome|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63441|NCT02187861|O1|Outcome|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63442|NCT02187861|O4|Outcome|Chemotherapy-Containing Cohort: Arm C (BR)|Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63443|NCT02187861|O3|Outcome|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63444|NCT02187861|O2|Outcome|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63445|NCT02187861|O1|Outcome|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63446|NCT02187861|O4|Outcome|Chemotherapy-Containing Cohort: Arm C (BR)|Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63447|NCT02187861|O3|Outcome|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63448|NCT02187861|O2|Outcome|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63449|NCT02187861|O1|Outcome|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63450|NCT02187861|O4|Outcome|Chemotherapy-Containing Cohort: Arm C (BR)|Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63451|NCT02187861|O3|Outcome|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63452|NCT02187861|O2|Outcome|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63474|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
63453|NCT02187861|O1|Outcome|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63454|NCT02187861|O4|Outcome|Chemotherapy-Containing Cohort: Arm C (BR)|Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63455|NCT02187861|O3|Outcome|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63456|NCT02187861|O2|Outcome|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63457|NCT02187861|O1|Outcome|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63458|NCT02187861|O4|Outcome|Chemotherapy-Containing Cohort: Arm C (BR)|Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63459|NCT02187861|O3|Outcome|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63460|NCT02187861|O2|Outcome|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63461|NCT02187861|O1|Outcome|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63462|NCT02187861|E4|Reported Event|Chemotherapy-Containing Cohort: Arm C (BR)|Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63463|NCT02187861|E3|Reported Event|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63464|NCT02187861|E2|Reported Event|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
63465|NCT02187861|E1|Reported Event|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
63466|NCT02187809|B1|Baseline|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
63467|NCT02187809|P1|Participant Flow|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
63468|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
63469|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
63470|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
63471|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
63472|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
63473|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
63478|NCT02187744|B1|Baseline|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
63479|NCT02187744|P2|Participant Flow|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
63480|NCT02187744|P1|Participant Flow|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin area under the concentration versus time curve (AUC) 6 were administered on Day 1 of each cycle.
63481|NCT02187744|O2|Outcome|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
63482|NCT02187744|O1|Outcome|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
63483|NCT02187744|O2|Outcome|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
63484|NCT02187744|O1|Outcome|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
63485|NCT02187744|O2|Outcome|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
63486|NCT02187744|O1|Outcome|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
63487|NCT02187744|O2|Outcome|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
63488|NCT02187744|O1|Outcome|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
63489|NCT02187744|O2|Outcome|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
63490|NCT02187744|O1|Outcome|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
63491|NCT02187744|O2|Outcome|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
63492|NCT02187744|O1|Outcome|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
63493|NCT02187744|E2|Reported Event|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
63494|NCT02187744|E1|Reported Event|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
63495|NCT02187029|B5|Baseline|Total|Total of all reporting groups
63496|NCT02187029|B4|Baseline|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
63497|NCT02187029|B3|Baseline|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
63498|NCT02187029|B2|Baseline|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
63499|NCT02187029|B1|Baseline|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
63500|NCT02187029|P4|Participant Flow|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
63501|NCT02187029|P3|Participant Flow|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
63502|NCT02187029|P2|Participant Flow|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
63503|NCT02187029|P1|Participant Flow|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
63504|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
63536|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
63505|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
63506|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
63507|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
63508|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
63509|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
63510|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
63511|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
63512|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
63513|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
63514|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
63515|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
63516|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
63517|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
63518|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
63519|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
63520|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
63521|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
63522|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
63523|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
63524|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
63525|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
63526|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
63527|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
63528|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
63529|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
63530|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
63531|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
63532|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
63533|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
63534|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
63535|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
65324|NCT02171234|P3|Participant Flow|Group 2 - 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine 400mg
63537|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
63538|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
63539|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
63540|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
63541|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
63542|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
63543|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
63544|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
63545|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
63546|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
63547|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
63548|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
63549|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
63550|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
63551|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
63552|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
63553|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
63554|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
63555|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
63556|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
63557|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
63558|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
63559|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
63560|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
63561|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
63562|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
63563|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
63564|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
63565|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
63566|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
63606|NCT02187016|O1|Outcome|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
63567|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
63568|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
63569|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
63570|NCT02187029|E4|Reported Event|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
63571|NCT02187029|E3|Reported Event|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
63572|NCT02187029|E2|Reported Event|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
63573|NCT02187029|E1|Reported Event|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
63574|NCT02187016|B5|Baseline|Total|Total of all reporting groups
63575|NCT02187016|B4|Baseline|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
63576|NCT02187016|B3|Baseline|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
63577|NCT02187016|B2|Baseline|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
63578|NCT02187016|B1|Baseline|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
63579|NCT02187016|P4|Participant Flow|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
63580|NCT02187016|P3|Participant Flow|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
63581|NCT02187016|P2|Participant Flow|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
63582|NCT02187016|P1|Participant Flow|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
63583|NCT02187016|O4|Outcome|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
63584|NCT02187016|O3|Outcome|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
63585|NCT02187016|O2|Outcome|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
63586|NCT02187016|O1|Outcome|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
63587|NCT02187016|O4|Outcome|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
63588|NCT02187016|O3|Outcome|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
63589|NCT02187016|O2|Outcome|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
63590|NCT02187016|O1|Outcome|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
63591|NCT02187016|O4|Outcome|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
63592|NCT02187016|O3|Outcome|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
63593|NCT02187016|O2|Outcome|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
63594|NCT02187016|O1|Outcome|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
63595|NCT02187016|O4|Outcome|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
63596|NCT02187016|O3|Outcome|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
63597|NCT02187016|O2|Outcome|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
63598|NCT02187016|O1|Outcome|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
63599|NCT02187016|O4|Outcome|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
63600|NCT02187016|O3|Outcome|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
63601|NCT02187016|O2|Outcome|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
63602|NCT02187016|O1|Outcome|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
63603|NCT02187016|O4|Outcome|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
63604|NCT02187016|O3|Outcome|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
63605|NCT02187016|O2|Outcome|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
104926|NCT01955564|E2|Reported Event|Cohort 1|NW-3509a 1mg, single dose
63608|NCT02187016|E3|Reported Event|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
63609|NCT02187016|E2|Reported Event|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
63610|NCT02187016|E1|Reported Event|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
63611|NCT02186873|B3|Baseline|Total|Total of all reporting groups
63612|NCT02186873|B2|Baseline|Group 2: Golimumab|Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
63613|NCT02186873|B1|Baseline|Group 1: Placebo Then Golimumab|Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
63614|NCT02186873|P2|Participant Flow|Group 2: Golimumab|Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
63615|NCT02186873|P1|Participant Flow|Group 1: Placebo Then Golimumab|Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
63616|NCT02186873|O2|Outcome|Group 2: Golimumab|Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
63617|NCT02186873|O1|Outcome|Group 1: Placebo Then Golimumab|Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
63618|NCT02186873|O2|Outcome|Group 2: Golimumab|Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
63619|NCT02186873|O1|Outcome|Group 1: Placebo Then Golimumab|Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
63620|NCT02186873|O2|Outcome|Group 2: Golimumab|Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
63621|NCT02186873|O1|Outcome|Group 1: Placebo Then Golimumab|Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
63622|NCT02186873|O2|Outcome|Group 2: Golimumab|Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
63623|NCT02186873|O1|Outcome|Group 1: Placebo Then Golimumab|Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
63624|NCT02186873|O2|Outcome|Group 2: Golimumab|Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
63625|NCT02186873|O1|Outcome|Group 1: Placebo Then Golimumab|Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
63626|NCT02186873|O2|Outcome|Group 2: Golimumab|Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
63627|NCT02186873|O1|Outcome|Group 1: Placebo Then Golimumab|Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
63628|NCT02186873|O2|Outcome|Group 2: Golimumab|Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
63629|NCT02186873|O1|Outcome|Group 1: Placebo Then Golimumab|Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
63630|NCT02186873|O2|Outcome|Group 2: Golimumab|Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
63631|NCT02186873|O1|Outcome|Group 1: Placebo Then Golimumab|Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
63632|NCT02186873|O2|Outcome|Group 2: Golimumab|Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
63633|NCT02186873|O1|Outcome|Group 1: Placebo Then Golimumab|Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
63634|NCT02186873|E3|Reported Event|Golimumab 2 mg/kg|Participants who received at least one dose of 2 mg/kg golimumab from Week 0 onward. Follow-up started from the first golimumab 2 mg/kg dose for this treatment group.
63784|NCT02185105|O2|Outcome|Comfilcon A Toric|"Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair."
63635|NCT02186873|E2|Reported Event|Placebo Then Golimumab 2 mg/kg|Participants who received placebo were crossed over to golimumab 2 mg/kg at Week 16. Participants may have also inadvertently received golimumab 2 mg/kg prior to Week 16. Participants may have missed one or more golimumab doses. Follow-up started from the first golimumab 2 mg/kg dose for this treatment group. Participants who inadvertently received golimumab 2 mg/kg prior to Week 16 were applicable to include in this group.
63636|NCT02186873|E1|Reported Event|Placebo|Participants who received placebo only (at least 1 dose) through Week 16. Follow-up was based on the period the participant was receiving placebo (from Week 0) up to the first golimumab 2 mg/kg dose for this treatment group.
63637|NCT02186808|B1|Baseline|Procera® Bridge Zirconia|"Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.~Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible."
63638|NCT02186808|P1|Participant Flow|Procera® Bridge Zirconia|"Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.~Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible."
63639|NCT02186808|O1|Outcome|Procera® Bridge Zirconia|"Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.~Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible."
63640|NCT02186808|O1|Outcome|Procera® Bridge Zirconia|"Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.~Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible."
63641|NCT02186808|E1|Reported Event|Procera® Bridge Zirconia|"Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.~Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible."
63642|NCT02186665|B3|Baseline|Total|Total of all reporting groups
63643|NCT02186665|B2|Baseline|Placebo|Placebo comparator
63644|NCT02186665|B1|Baseline|Calcitriol Ointment|Calcitriol 3 mcg/g Ointment
63645|NCT02186665|P2|Participant Flow|Placebo|Placebo comparator
63646|NCT02186665|P1|Participant Flow|Calcitriol Ointment|Calcitriol 3 mcg/g Ointment
63647|NCT02186665|O2|Outcome|Placebo|Placebo Comparator
63648|NCT02186665|O1|Outcome|Calcitriol Ointment|Calcitriol 3 mcg/g Ointment
63649|NCT02186665|E2|Reported Event|Placebo|Placebo Comparator
63650|NCT02186665|E1|Reported Event|Calcitriol Ointment|Calcitriol 3 mcg/g Ointment
63651|NCT02186587|B3|Baseline|Total|Total of all reporting groups
63652|NCT02186587|B2|Baseline|Off-the-shelf|"Subjects in this arm will receive an off-the-shelf total knee implant as part of standard of care.~Off-the-shelf total knee implant"
63653|NCT02186587|B1|Baseline|ConforMIS|"Subjects in this arm will be having a ConforMIS custom total knee implant as part of standard of care.~ConforMIS custom total knee"
63654|NCT02186587|P2|Participant Flow|Off-the-shelf|"Subjects in this arm will receive an off-the-shelf total knee implant.~Off-the-shelf total knee implant"
63655|NCT02186587|P1|Participant Flow|ConforMIS|"Subjects in this arm will receive a ConforMIS custom total knee implant.~ConforMIS custom total knee"
63656|NCT02186587|O1|Outcome|ConforMIS|"Subjects in this arm will be having a ConforMIS custom total knee implant as part of standard of care.~ConforMIS custom total knee"
63657|NCT02186587|E2|Reported Event|Off-the-shelf|"Subjects in this arm will receive an off-the-shelf total knee implant.~Off-the-shelf total knee implant"
63658|NCT02186587|E1|Reported Event|ConforMIS|"Subjects in this arm will receive a ConforMIS custom total knee implant.~ConforMIS custom total knee"
63659|NCT02186223|B1|Baseline|The Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
63660|NCT02186223|P1|Participant Flow|The Angel® Catheter|"All eligible subjects will receive an Angel® Catheter.~The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
63661|NCT02186223|O1|Outcome|Angel® Catheter Pre-Removal Cavogram|Number analyzed includes all subjects that had an Angel® Catheter placed, and a cavogram was performed prior to removal.
63662|NCT02186223|O1|Outcome|The Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
63663|NCT02186223|O1|Outcome|The Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
63664|NCT02186223|O1|Outcome|The Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
63665|NCT02186223|O1|Outcome|The Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
63666|NCT02186223|O1|Outcome|The Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
63667|NCT02186223|E1|Reported Event|The Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
63668|NCT02185729|B1|Baseline|Healthy Volunteer|"Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat), ClinOleic (olive oil), dextrose (sugar) without fat, and a 24-hour infusion of normal saline (control)~Intralipid~ClinOleic~Dextrose~Saline (control)"
63669|NCT02185729|P1|Participant Flow|Healthy Volunteer|"Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat), ClinOleic (olive oil), dextrose (sugar) without fat, and a 24-hour infusion of normal saline (control)~Intralipid~ClinOleic~Dextrose~Saline (control)"
63670|NCT02185729|O4|Outcome|Saline|Healthy subjects receive 24-hour infusion of normal saline (control)
63671|NCT02185729|O3|Outcome|Dextrose|Healthy subjects receive 24-hour TPN infusion of dextrose (sugar) without fat
63672|NCT02185729|O2|Outcome|ClinOleic|Healthy subjects receive 24-hour TPN infusion of ClinOleic (olive oil)
63673|NCT02185729|O1|Outcome|Intralipid|Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat)
63674|NCT02185729|O4|Outcome|Saline|Healthy subjects receive 24-hour infusion of normal saline (control)
63675|NCT02185729|O3|Outcome|Dextrose|Healthy subjects receive 24-hour TPN infusion of dextrose (sugar) without fat
63676|NCT02185729|O2|Outcome|ClinOleic|Healthy subjects receive 24-hour TPN infusion of ClinOleic (olive oil)
63677|NCT02185729|O1|Outcome|Intralipid|Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat)
63678|NCT02185729|O4|Outcome|Saline|Healthy subjects receive 24-hour infusion of normal saline (control)
63679|NCT02185729|O3|Outcome|Dextrose|Healthy subjects receive 24-hour TPN infusion of dextrose (sugar) without fat
63680|NCT02185729|O2|Outcome|ClinOleic|Healthy subjects receive 24-hour TPN infusion of ClinOleic (olive oil)
63681|NCT02185729|O1|Outcome|Intralipid|Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat)
63682|NCT02185729|E1|Reported Event|Healthy Volunteer|Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat), ClinOleic (olive oil), dextrose (sugar) without fat, and a 24-hour infusion of normal saline (control)
63683|NCT02185534|B7|Baseline|Total|Total of all reporting groups
63684|NCT02185534|B6|Baseline|First US, Then Japanese, Then European Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 3
63685|NCT02185534|B5|Baseline|First US, Then European, Then Japanese Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 1, a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 3
63686|NCT02185534|B4|Baseline|First Japanese, Then US, Then European Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi-Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 3
63687|NCT02185534|B3|Baseline|First Japanese, Then European, Then US Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi-Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 3
63688|NCT02185534|B2|Baseline|First European, Then US, Then Japanese Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi-Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 3
63689|NCT02185534|B1|Baseline|First European, Then Japanese, Then US Clopidogrel|"A single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA~- test) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 3"
63690|NCT02185534|P6|Participant Flow|First US, Then Japanese, Then European Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 3
63691|NCT02185534|P5|Participant Flow|First US, Then European, Then Japanese Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 1, a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 3
104927|NCT01955564|E1|Reported Event|Placebo|placebo, single dose
63692|NCT02185534|P4|Participant Flow|First Japanese, Then US, Then European Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi-Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 3
63693|NCT02185534|P3|Participant Flow|First Japanese, Then European, Then US Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi-Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 3
63694|NCT02185534|P2|Participant Flow|First European, Then US, Then Japanese Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi-Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 3
63695|NCT02185534|P1|Participant Flow|First European, Then Japanese, Then US Clopidogrel|"A single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA~- test) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 3"
63696|NCT02185534|O3|Outcome|US Clopidogrel Tablets, 75 mg|Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference)
63697|NCT02185534|O2|Outcome|Japanese Clopidogrel Tablets, 75 mg|Treatment B: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Brystol-Myer Squibb,Sanofi- Aventis, reference)
63698|NCT02185534|O1|Outcome|European Clopidogrel Tablets, 75 mg|Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet Eu(Zyllt, KRKA - test)
63699|NCT02185534|O3|Outcome|US Clopidogrel Tablets, 75 mg|Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference)
63700|NCT02185534|O2|Outcome|Japanese Clopidogrel Tablets, 75 mg|Treatment B: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Brystol-Myer Squibb,Sanofi- Aventis, reference)
63701|NCT02185534|O1|Outcome|European Clopidogrel Tablets, 75 mg|Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet Eu(Zyllt, KRKA - test)
63702|NCT02185534|O3|Outcome|US Clopidogrel Tablets, 75 mg|Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference)
63703|NCT02185534|O2|Outcome|Japanese Clopidogrel Tablets, 75 mg|Treatment B: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Brystol-Myer Squibb,Sanofi- Aventis, reference)
63704|NCT02185534|O1|Outcome|European Clopidogrel Tablets, 75 mg|Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet Eu(Zyllt, KRKA - test)
63705|NCT02185534|E4|Reported Event|Total Number of Participants|total number of subjects exposed to any treatment
63706|NCT02185534|E3|Reported Event|US Clopidogrel Tablets, 75 mg|Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference)
63707|NCT02185534|E2|Reported Event|Japanese Clopidogrel Tablets, 75 mg|Treatment B: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Brystol-Myer Squibb,Sanofi- Aventis, reference)
63708|NCT02185534|E1|Reported Event|European Clopidogrel Tablets, 75 mg|Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet Eu(Zyllt, KRKA - test)
63709|NCT02185339|B3|Baseline|Total|Total of all reporting groups
63710|NCT02185339|B2|Baseline|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
63711|NCT02185339|B1|Baseline|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
63712|NCT02185339|P2|Participant Flow|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
63713|NCT02185339|P1|Participant Flow|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
63785|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|"Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
64075|NCT02181140|E1|Reported Event|EUS Guided FNA|EUS FNA of lesions with aspirating fine needle and pro core fine needle in a randomized order
63714|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
63715|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
63716|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
63717|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
63718|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
63719|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
63720|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
63721|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
63722|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
63723|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
63786|NCT02185105|O2|Outcome|Comfilcon A Toric|"Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair."
64151|NCT02180061|B2|Baseline|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
63724|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
63725|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
63726|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
63727|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
63728|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
63729|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
63730|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
63731|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
63732|NCT02185339|E2|Reported Event|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
63733|NCT02185339|E1|Reported Event|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
63734|NCT02185183|B1|Baseline|AlequelTM|"AlequelTM~Alequel: Alequel"
63735|NCT02185183|P1|Participant Flow|AlequelTM 30 ng Once a Day Orally|"AlequelTM 30 ng once a day orally~Alequel: Alequel"
63736|NCT02185183|O1|Outcome|AlequelTM|"AlequelTM~Alequel: Alequel"
63737|NCT02185183|E1|Reported Event|AlequelTM|"AlequelTM~Alequel: Alequel"
63738|NCT02185131|B3|Baseline|Total|Total of all reporting groups
63739|NCT02185131|B2|Baseline|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
63740|NCT02185131|B1|Baseline|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
63741|NCT02185131|P2|Participant Flow|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
63742|NCT02185131|P1|Participant Flow|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
63743|NCT02185131|O2|Outcome|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
63744|NCT02185131|O1|Outcome|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
63745|NCT02185131|O2|Outcome|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
63746|NCT02185131|O1|Outcome|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
63747|NCT02185131|E2|Reported Event|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
63748|NCT02185131|E1|Reported Event|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
63749|NCT02185105|B1|Baseline|Comfilcon A XR Toric (Extended Range) / Comfilcon A Toric|"Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
63750|NCT02185105|P1|Participant Flow|Comfilcon A XR Toric (Extended Range) / Comfilcon A Toric|"Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
63751|NCT02185105|O2|Outcome|Comfilcon A Toric|
63752|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
63753|NCT02185105|O2|Outcome|Comfilcon A Toric|
63754|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
63755|NCT02185105|O2|Outcome|Comfilcon A Toric|
63756|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
63757|NCT02185105|O2|Outcome|Comfilcon A Toric|
63758|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
63759|NCT02185105|O2|Outcome|Comfilcon A Toric|
63760|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
63761|NCT02185105|O2|Outcome|Comfilcon A Toric|
63762|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
63763|NCT02185105|O2|Outcome|Comfilcon A Toric|
63764|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
63787|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|"Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
63788|NCT02185105|O2|Outcome|Comfilcon A Toric|"Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair."
63789|NCT02185105|O1|Outcome|Comfilcon A XR (Extended Range) Toric|"Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
63790|NCT02185105|E2|Reported Event|Comfilcon A|"Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A MTO: Randomized to a test lens in one eye and control lens in the other as a matched pair."
63791|NCT02185105|E1|Reported Event|Comfilcon A MTO|"Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
63792|NCT02184624|B6|Baseline|Total|Total of all reporting groups
63793|NCT02184624|B5|Baseline|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63794|NCT02184624|B4|Baseline|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63795|NCT02184624|B3|Baseline|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63796|NCT02184624|B2|Baseline|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63797|NCT02184624|B1|Baseline|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63798|NCT02184624|P5|Participant Flow|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63799|NCT02184624|P4|Participant Flow|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63800|NCT02184624|P3|Participant Flow|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63801|NCT02184624|P2|Participant Flow|Sub-study 2: ELLIPTA Vs Metered-dose Inhaler (MDI)|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63802|NCT02184624|P1|Participant Flow|Sub-study 1:ELLIPTA Versus (Vs) DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily Chronic Obstructive Pulmonary Disease (COPD) maintenance and other medication(s) during the study.
63803|NCT02184624|O5|Outcome|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63804|NCT02184624|O4|Outcome|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63805|NCT02184624|O3|Outcome|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63806|NCT02184624|O2|Outcome|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63807|NCT02184624|O1|Outcome|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63808|NCT02184624|O5|Outcome|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63809|NCT02184624|O4|Outcome|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63810|NCT02184624|O3|Outcome|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63811|NCT02184624|O2|Outcome|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63812|NCT02184624|O1|Outcome|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63813|NCT02184624|O5|Outcome|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63814|NCT02184624|O4|Outcome|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63815|NCT02184624|O3|Outcome|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63816|NCT02184624|O2|Outcome|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63817|NCT02184624|O1|Outcome|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63818|NCT02184624|O5|Outcome|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63819|NCT02184624|O4|Outcome|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63820|NCT02184624|O3|Outcome|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63821|NCT02184624|O2|Outcome|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63822|NCT02184624|O1|Outcome|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63823|NCT02184624|O5|Outcome|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63824|NCT02184624|O4|Outcome|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63825|NCT02184624|O3|Outcome|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63826|NCT02184624|O2|Outcome|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63827|NCT02184624|O1|Outcome|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63828|NCT02184624|O5|Outcome|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63829|NCT02184624|O4|Outcome|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63830|NCT02184624|O3|Outcome|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63831|NCT02184624|O2|Outcome|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63832|NCT02184624|O1|Outcome|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63833|NCT02184624|O5|Outcome|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63834|NCT02184624|O4|Outcome|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63835|NCT02184624|O3|Outcome|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
64152|NCT02180061|B1|Baseline|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
63836|NCT02184624|O2|Outcome|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63837|NCT02184624|O1|Outcome|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63838|NCT02184624|E5|Reported Event|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63839|NCT02184624|E4|Reported Event|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63840|NCT02184624|E3|Reported Event|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63841|NCT02184624|E2|Reported Event|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63842|NCT02184624|E1|Reported Event|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
63843|NCT02184494|B4|Baseline|Total|Total of all reporting groups
63844|NCT02184494|B3|Baseline|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
63845|NCT02184494|B2|Baseline|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
63846|NCT02184494|B1|Baseline|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
63847|NCT02184494|P3|Participant Flow|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
63848|NCT02184494|P2|Participant Flow|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
63849|NCT02184494|P1|Participant Flow|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
63850|NCT02184494|O3|Outcome|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
63851|NCT02184494|O2|Outcome|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
63883|NCT02183675|P4|Participant Flow|T80-A5 / T80-H12.5 / T80-A5-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)"
104928|NCT01955473|B6|Baseline|Total|Total of all reporting groups
63852|NCT02184494|O1|Outcome|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
63853|NCT02184494|O3|Outcome|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
63854|NCT02184494|O2|Outcome|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
63855|NCT02184494|O1|Outcome|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
63856|NCT02184494|O3|Outcome|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
63857|NCT02184494|O2|Outcome|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
63858|NCT02184494|O1|Outcome|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
63859|NCT02184494|O3|Outcome|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
63860|NCT02184494|O2|Outcome|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
63861|NCT02184494|O1|Outcome|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
63862|NCT02184494|O3|Outcome|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
63863|NCT02184494|O2|Outcome|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
63941|NCT02182115|B1|Baseline|Standard of Care|"Surgeon's routine for preoperative showering. Surgeon's instructions may include advising patients to use an antiseptic soap prior to surgery.~Other Name: Follow surgeon's instructions for pre-operative bathing."
65325|NCT02171234|P2|Participant Flow|Group 1 - 200 mg b.i.d.|BIA 2-093 200mg (twice daily)
63864|NCT02184494|O1|Outcome|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
63865|NCT02184494|E3|Reported Event|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
63866|NCT02184494|E2|Reported Event|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
63867|NCT02184494|E1|Reported Event|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
63868|NCT02184208|B1|Baseline|Patient Categorization|We retrospectively categorized the ventilation and oxygenation statuses of patients within our PICU utilizing 15 rules based algorithms. Targets were predetermined based on generally accepted practices. All patient categories were calculated and presented as a percent score (0-100%) of acceptable ventilation, acceptable oxygenation, barotrauma free and volutrauma free states.
63869|NCT02184208|P1|Participant Flow|Patient Categorization|We retrospectively categorized the ventilation and oxygenation statuses of patients within our PICU utilizing 15 rules based algorithms. Targets were predetermined based on generally accepted practices. All patient categories were calculated and presented as a percent score (0-100%) of acceptable ventilation, acceptable oxygenation, barotrauma free and volutrauma free states.
63870|NCT02184208|O2|Outcome|Pulmonary Mechanics|Heart rate (HR), respiratory rate (RR), spontaneous respiratory rate (Spont. RR) and modified ventilation index (MVI) subcategory.
63871|NCT02184208|O1|Outcome|Device Utlization Following Extubation|The ERT score predicted device utilization
63872|NCT02184208|E2|Reported Event|Pulmonary Mechanics|All patients on mechanical ventilation were evaluated.
63873|NCT02184208|E1|Reported Event|Device Utlization Following Extubation|Patients who were extubated were evaluated.
63874|NCT02183675|B7|Baseline|Total|Total of all reporting groups
63875|NCT02183675|B6|Baseline|T80-H12.5 / T80-A5-H12.5 / T80-A5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)"
63876|NCT02183675|B5|Baseline|T80-A5-H12.5 / T80-A5 / T80-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)"
63877|NCT02183675|B4|Baseline|T80-A5 / T80-H12.5 / T80-A5-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)"
63878|NCT02183675|B3|Baseline|T80-A5 / T80-A5-H12.5 / T80-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)"
63879|NCT02183675|B2|Baseline|T80-H12.5 / T80-A5 / T80-A5-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)"
63880|NCT02183675|B1|Baseline|T80-A5-H12.5 / T80-H12.5 / T80-A5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)"
63881|NCT02183675|P6|Participant Flow|T80-H12.5 / T80-A5-H12.5 / T80-A5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)"
63882|NCT02183675|P5|Participant Flow|T80-A5-H12.5 / T80-A5 / T80-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)"
63942|NCT02182115|P2|Participant Flow|Antiseptic Bundle|"Patients to use study bundle for 5 days prior to scheduled surgery with the following medications to use at home.~Chlorhexidine gluconate soap applied for bathing daily.~Chlorhexidine gluconate mouthrinse used to rinse mouth twice daily.~Nasal mupirocin to applied inside nostrils twice daily."
63884|NCT02183675|P3|Participant Flow|T80-A5 / T80-A5-H12.5 / T80-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)"
63885|NCT02183675|P2|Participant Flow|T80-H12.5 / T80-A5 / T80-A5-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)"
63886|NCT02183675|P1|Participant Flow|T80-A5-H12.5 / T80-H12.5 / T80-A5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg/ hydrochlorothiazide (HCTZ) 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/ HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)"
63887|NCT02183675|O2|Outcome|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
63888|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
63889|NCT02183675|O2|Outcome|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
63890|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
63891|NCT02183675|O2|Outcome|T80-A5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days
63892|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
63893|NCT02183675|O2|Outcome|T80-A5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days
63894|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
63895|NCT02183675|O2|Outcome|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
63896|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
63897|NCT02183675|O3|Outcome|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
63898|NCT02183675|O2|Outcome|T80-A5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days
63899|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
63900|NCT02183675|O3|Outcome|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
63901|NCT02183675|O2|Outcome|T80-A5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days
63902|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
63903|NCT02183675|E4|Reported Event|All Patients|"All participants in the study. Participants received three treatments in a randomised order~T80-A5-H12.5~T80-A5~T80-H12.5"
63904|NCT02183675|E3|Reported Event|T80-A5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days
63905|NCT02183675|E2|Reported Event|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
63906|NCT02183675|E1|Reported Event|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
63907|NCT02183519|B3|Baseline|Total|Total of all reporting groups
63908|NCT02183519|B2|Baseline|Parkinson's Disease|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
63909|NCT02183519|B1|Baseline|Healthy Older Adults|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
63943|NCT02182115|P1|Participant Flow|Standard of Care|"Surgeon's routine for preoperative showering.~standard of care: Surgeon's instructions may include advising patients to use an antiseptic soap prior to surgery."
63979|NCT02181673|O2|Outcome|Golimumab|Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
63980|NCT02181673|O1|Outcome|Placebo|Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
63910|NCT02183519|P2|Participant Flow|Parkinson's Disease|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
63911|NCT02183519|P1|Participant Flow|Healthy Older Adults|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
63912|NCT02183519|O2|Outcome|Parkinson's Disease|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
63913|NCT02183519|O1|Outcome|Healthy Older Adults|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
63914|NCT02183519|E2|Reported Event|Parkinson's Disease|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
63915|NCT02183519|E1|Reported Event|Healthy Older Adults|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
63916|NCT02182895|B3|Baseline|Total|Total of all reporting groups
63917|NCT02182895|B2|Baseline|Standard Therapy Group|Standard therapy group will receive basal-bolus insulin starting at a dose of 0.5 units/kg/day; given half as insulin glargine and half as insulin aspart. In addition, the standard therapy group will receive the correctional sliding scale insulin therapy before each meal and bedtime.
63918|NCT02182895|B1|Baseline|Saxagliptin Group|"DPP4 inhibitor therapy group will receive saxagliptin 2.5 to 5 mg daily in addition to correctional sliding scale insulin therapy before each meal and bedtime.~Saxagliptin: 2.5-5 mg daily"
63919|NCT02182895|P2|Participant Flow|Standard Therapy Group|No saxagliptin treatment
63920|NCT02182895|P1|Participant Flow|Saxagliptin Group|saxagliptin 2.5-5 mg daily
63921|NCT02182895|O2|Outcome|Standard Therapy Group|No saxagliptin treatment
63922|NCT02182895|O1|Outcome|Saxagliptin Group|saxagliptin 2.5-5 mg daily
63923|NCT02182895|O2|Outcome|Standard Therapy Group|No saxagliptin treatment
63924|NCT02182895|O1|Outcome|Saxagliptin Group|saxagliptin 2.5-5 mg daily
63925|NCT02182895|O2|Outcome|Standard Therapy Group|No saxagliptin treatment
63926|NCT02182895|O1|Outcome|Saxagliptin Group|saxagliptin 2.5-5 mg daily
63927|NCT02182895|O2|Outcome|Standard Therapy Group|No saxagliptin treatment
63928|NCT02182895|O1|Outcome|Saxagliptin Group|saxagliptin 2.5-5 mg daily
63929|NCT02182895|O2|Outcome|Standard Therapy Group|No saxagliptin treatment
63930|NCT02182895|O1|Outcome|Saxagliptin Group|saxagliptin 2.5-5 mg daily
63931|NCT02182895|O2|Outcome|Standard Therapy Group|No saxagliptin treatment
63932|NCT02182895|O1|Outcome|Saxagliptin Group|saxagliptin 2.5-5 mg daily
63933|NCT02182895|O2|Outcome|Standard Therapy Group|No saxagliptin treatment
63934|NCT02182895|O1|Outcome|Saxagliptin Group|saxagliptin 2.5-5 mg daily
63935|NCT02182895|O2|Outcome|Standard Therapy Group|No saxagliptin treatment
63936|NCT02182895|O1|Outcome|Saxagliptin Group|saxagliptin 2.5-5 mg daily
63937|NCT02182895|E2|Reported Event|Standard Therapy Group|No saxagliptin treatment
63938|NCT02182895|E1|Reported Event|Saxagliptin Group|saxagliptin 2.5-5 mg daily
63939|NCT02182115|B3|Baseline|Total|Total of all reporting groups
63940|NCT02182115|B2|Baseline|Antiseptic Bundle|"Patients to use study bundle for 5 days prior to scheduled surgery with the following medications to use at home.~Chlorhexidine gluconate soap applied for bathing daily. Chlorhexidine gluconate mouthrinse used to rinse mouth twice daily. Nasal mupirocin to applied inside nostrils twice daily."
64348|NCT02178059|O1|Outcome|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation
63944|NCT02182115|O2|Outcome|Antiseptic Bundle|"Patients to use study bundle for 5 days prior to scheduled surgery with the following medications to use at home.~Chlorhexidine gluconate soap applied for bathing daily.~Chlorhexidine gluconate mouthrinse used to rinse mouth twice daily.~Nasal mupirocin to applied inside nostrils twice daily.~antiseptic bundle: 1. Chlorhexidine gluconate liquid soap for bathing daily. 2. Chlorhexidine gluconate mouthrinse to use twice daily. 3. Nasal mupirocin to apply twice daily."
63945|NCT02182115|O1|Outcome|Standard of Care|"Surgeon's routine for preoperative showering.~standard of care: Surgeon's instructions may include advising patients to use an antiseptic soap prior to surgery."
63946|NCT02182115|E2|Reported Event|Antiseptic Bundle|Used three drug antiseptic bundle for 5 days.
63947|NCT02182115|E1|Reported Event|Standard of Care|Used surgeon recommended soap for two pre-op showers, one the night before and one the morning of surgery.
63948|NCT02181790|B3|Baseline|Total|Total of all reporting groups
63949|NCT02181790|B2|Baseline|Second Group|"excimer laser treatment to both palms and/or soles~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
63950|NCT02181790|B1|Baseline|First Group|"excimer laser treatment to one palm and/or one sole~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
63951|NCT02181790|P2|Participant Flow|Excimer Laser (Both Palms/Soles)|"excimer laser treatment to both palms and/or soles~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
63952|NCT02181790|P1|Participant Flow|Excimer Laser (One Palm/Sole)|"excimer laser treatment to one palm and/or one sole~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
63953|NCT02181790|O2|Outcome|Excimer Laser (Both Palms/Soles)|"excimer laser treatment to both palms and/or soles~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
63954|NCT02181790|O1|Outcome|Excimer Laser (One Palm/Sole)|"excimer laser treatment to one palm and/or one sole~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
63955|NCT02181790|O2|Outcome|Second Group|"excimer laser treatment to both palms and/or soles~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
63956|NCT02181790|O1|Outcome|First Group|"excimer laser treatment to one palm and/or one sole~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
63957|NCT02181790|E2|Reported Event|Second Group|"excimer laser treatment to both palms and/or soles~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
63958|NCT02181790|E1|Reported Event|First Group|"excimer laser treatment to one palm and/or one sole~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
63959|NCT02181673|B3|Baseline|Total|Total of all reporting groups
63960|NCT02181673|B2|Baseline|Golimumab 2 mg/kg|Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and every 8 weeks thereafter up to Week 52. At Week 24, participants received a placebo intravenous infusion to maintain the blind.
63961|NCT02181673|B1|Baseline|Placebo (Week 0-24)|Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
63962|NCT02181673|P3|Participant Flow|Golimumab 2 mg/kg (Week 0-60)|Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and every 8 weeks thereafter up to Week 52. At Week 24, participants received a placebo intravenous infusion to maintain the blind.
63963|NCT02181673|P2|Participant Flow|Placebo Then Golimumab 2 mg/kg (Week 24-60)|Participants who received placebo up to Week 20 were then crossed over at Week 24 to receive intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Week 24, 28 and every 8 weeks thereafter up to Week 52.
63964|NCT02181673|P1|Participant Flow|Placebo (Week 0-24)|Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
63965|NCT02181673|O2|Outcome|Golimumab|Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
63966|NCT02181673|O1|Outcome|Placebo|Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
63967|NCT02181673|O2|Outcome|Golimumab|Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
63968|NCT02181673|O1|Outcome|Placebo|Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
63969|NCT02181673|O2|Outcome|Golimumab|Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
63970|NCT02181673|O1|Outcome|Placebo|Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
63971|NCT02181673|O2|Outcome|Golimumab|Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
63972|NCT02181673|O1|Outcome|Placebo|Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
63973|NCT02181673|O2|Outcome|Golimumab|Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
63974|NCT02181673|O1|Outcome|Placebo|Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
63975|NCT02181673|O2|Outcome|Golimumab|Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
63976|NCT02181673|O1|Outcome|Placebo|Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
63977|NCT02181673|O2|Outcome|Golimumab|Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
63978|NCT02181673|O1|Outcome|Placebo|Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
64074|NCT02181140|O1|Outcome|EUS Guided Pro Core FNA|EUS guided punction of a lesion by pro core fine needle to evacuate histology and smear biologics
63981|NCT02181673|O2|Outcome|Golimumab|Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
63982|NCT02181673|O1|Outcome|Placebo|Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
63983|NCT02181673|O2|Outcome|Golimumab|Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
63984|NCT02181673|O1|Outcome|Placebo|Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
63985|NCT02181673|O2|Outcome|Golimumab|Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
63986|NCT02181673|O1|Outcome|Placebo|Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
63987|NCT02181673|E3|Reported Event|Golimumab 2 mg/kg (Week 0-60)|Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and every 8 weeks thereafter up to Week 52. At Week 24, participants received a placebo intravenous infusion to maintain the blind.
63988|NCT02181673|E2|Reported Event|Placebo Then Golimumab 2 mg/kg (Week 24-60)|Participants who received placebo up to Week 20 were then crossed over at Week 24 to receive intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Week 24, 28 and every 8 weeks thereafter up to Week 52.
63989|NCT02181673|E1|Reported Event|Placebo (Week 0-24)|Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
63990|NCT02181634|B1|Baseline|Nab-Paclitaxel and Gemcitabine|"Nab-Paclitaxel 125 mg/m² IV and Gemcitabine 1000 mg/m² on days 1, 8 and 15 every 28 days until progression or unacceptable toxicity.~Nab-Paclitaxel and Gemcitabine: Nab-Paclitaxel will be administered first, at a dose of 125 mg/m² IV over a period of 30 minutes; gemcitabine will be administered second, at a dose of 1000 mg/m² over a period of 30 minutes."
63991|NCT02181634|P1|Participant Flow|Nab-Paclitaxel and Gemcitabine|"Nab-Paclitaxel 125 mg/m² IV and Gemcitabine 1000 mg/m² on days 1, 8 and 15 every 28 days until progression or unacceptable toxicity.~Nab-Paclitaxel and Gemcitabine: Nab-Paclitaxel will be administered first, at a dose of 125 mg/m² IV over a period of 30 minutes; gemcitabine will be administered second, at a dose of 1000 mg/m² over a period of 30 minutes."
63992|NCT02181634|O1|Outcome|Nab-Paclitaxel and Gemcitabine|"Nab-Paclitaxel 125 mg/m² IV and Gemcitabine 1000 mg/m² on days 1, 8 and 15 every 28 days until progression or unacceptable toxicity.~Nab-Paclitaxel and Gemcitabine: Nab-Paclitaxel will be administered first, at a dose of 125 mg/m² IV over a period of 30 minutes; gemcitabine will be administered second, at a dose of 1000 mg/m² over a period of 30 minutes."
63993|NCT02181634|O1|Outcome|Nab-Paclitaxel and Gemcitabine|"Nab-Paclitaxel 125 mg/m² IV and Gemcitabine 1000 mg/m² on days 1, 8 and 15 every 28 days until progression or unacceptable toxicity.~Nab-Paclitaxel and Gemcitabine: Nab-Paclitaxel will be administered first, at a dose of 125 mg/m² IV over a period of 30 minutes; gemcitabine will be administered second, at a dose of 1000 mg/m² over a period of 30 minutes."
63994|NCT02181634|O1|Outcome|Nab-Paclitaxel and Gemcitabine|"Nab-Paclitaxel 125 mg/m² IV and Gemcitabine 1000 mg/m² on days 1, 8 and 15 every 28 days until progression or unacceptable toxicity.~Nab-Paclitaxel and Gemcitabine: Nab-Paclitaxel will be administered first, at a dose of 125 mg/m² IV over a period of 30 minutes; gemcitabine will be administered second, at a dose of 1000 mg/m² over a period of 30 minutes."
63995|NCT02181634|O1|Outcome|Nab-Paclitaxel and Gemcitabine|"Nab-Paclitaxel 125 mg/m² IV and Gemcitabine 1000 mg/m² on days 1, 8 and 15 every 28 days until progression or unacceptable toxicity.~Nab-Paclitaxel and Gemcitabine: Nab-Paclitaxel will be administered first, at a dose of 125 mg/m² IV over a period of 30 minutes; gemcitabine will be administered second, at a dose of 1000 mg/m² over a period of 30 minutes."
63996|NCT02181634|O1|Outcome|Nab-Paclitaxel and Gemcitabine|"Nab-Paclitaxel 125 mg/m² IV and Gemcitabine 1000 mg/m² on days 1, 8 and 15 every 28 days until progression or unacceptable toxicity.~Nab-Paclitaxel and Gemcitabine: Nab-Paclitaxel will be administered first, at a dose of 125 mg/m² IV over a period of 30 minutes; gemcitabine will be administered second, at a dose of 1000 mg/m² over a period of 30 minutes."
63997|NCT02181634|O1|Outcome|Nab-Paclitaxel and Gemcitabine|"Nab-Paclitaxel 125 mg/m² IV and Gemcitabine 1000 mg/m² on days 1, 8 and 15 every 28 days until progression or unacceptable toxicity.~Nab-Paclitaxel and Gemcitabine: Nab-Paclitaxel will be administered first, at a dose of 125 mg/m² IV over a period of 30 minutes; gemcitabine will be administered second, at a dose of 1000 mg/m² over a period of 30 minutes."
63998|NCT02181634|O1|Outcome|Nab-Paclitaxel and Gemcitabine|"Nab-Paclitaxel 125 mg/m² IV and Gemcitabine 1000 mg/m² on days 1, 8 and 15 every 28 days until progression or unacceptable toxicity.~Nab-Paclitaxel and Gemcitabine: Nab-Paclitaxel will be administered first, at a dose of 125 mg/m² IV over a period of 30 minutes; gemcitabine will be administered second, at a dose of 1000 mg/m² over a period of 30 minutes."
63999|NCT02181634|O1|Outcome|Nab-Paclitaxel and Gemcitabine|"Nab-Paclitaxel 125 mg/m² IV and Gemcitabine 1000 mg/m² on days 1, 8 and 15 every 28 days until progression or unacceptable toxicity.~Nab-Paclitaxel and Gemcitabine: Nab-Paclitaxel will be administered first, at a dose of 125 mg/m² IV over a period of 30 minutes; gemcitabine will be administered second, at a dose of 1000 mg/m² over a period of 30 minutes."
64000|NCT02181634|E1|Reported Event|Nab-Paclitaxel and Gemcitabine|"Nab-Paclitaxel 125 mg/m² IV and Gemcitabine 1000 mg/m² on days 1, 8 and 15 every 28 days until progression or unacceptable toxicity.~Nab-Paclitaxel and Gemcitabine: Nab-Paclitaxel will be administered first, at a dose of 125 mg/m² IV over a period of 30 minutes; gemcitabine will be administered second, at a dose of 1000 mg/m² over a period of 30 minutes."
64001|NCT02181530|B1|Baseline|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
64002|NCT02181530|P1|Participant Flow|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
64003|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
65326|NCT02171234|P1|Participant Flow|Placebo|PLC, Placebo
64004|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
64005|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
64006|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
64007|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
64008|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
64009|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
64010|NCT02181530|E1|Reported Event|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
64011|NCT02181517|B4|Baseline|Total|Total of all reporting groups
64012|NCT02181517|B3|Baseline|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
64013|NCT02181517|B2|Baseline|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64014|NCT02181517|B1|Baseline|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64015|NCT02181517|P3|Participant Flow|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
64016|NCT02181517|P2|Participant Flow|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64017|NCT02181517|P1|Participant Flow|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64018|NCT02181517|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
64019|NCT02181517|O2|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64020|NCT02181517|O1|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64021|NCT02181517|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
64022|NCT02181517|O2|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64023|NCT02181517|O1|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64024|NCT02181517|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
64025|NCT02181517|O2|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64026|NCT02181517|O1|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64027|NCT02181517|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
64028|NCT02181517|O2|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64029|NCT02181517|O1|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64030|NCT02181517|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
64031|NCT02181517|O2|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64032|NCT02181517|O1|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64033|NCT02181517|E3|Reported Event|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
64034|NCT02181517|E2|Reported Event|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64035|NCT02181517|E1|Reported Event|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64036|NCT02181504|B4|Baseline|Total|Total of all reporting groups
64037|NCT02181504|B3|Baseline|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
64038|NCT02181504|B2|Baseline|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64039|NCT02181504|B1|Baseline|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64040|NCT02181504|P3|Participant Flow|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
64041|NCT02181504|P2|Participant Flow|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64042|NCT02181504|P1|Participant Flow|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64043|NCT02181504|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
64044|NCT02181504|O2|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64045|NCT02181504|O1|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64046|NCT02181504|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
64047|NCT02181504|O2|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64048|NCT02181504|O1|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64049|NCT02181504|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
64050|NCT02181504|O2|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64051|NCT02181504|O1|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64052|NCT02181504|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
64053|NCT02181504|O2|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64054|NCT02181504|O1|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64055|NCT02181504|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
64056|NCT02181504|O2|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64057|NCT02181504|O1|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64058|NCT02181504|E3|Reported Event|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
64059|NCT02181504|E2|Reported Event|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64060|NCT02181504|E1|Reported Event|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
64061|NCT02181387|B3|Baseline|Total|Total of all reporting groups
64062|NCT02181387|B2|Baseline|Placebo|"placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 3 doses~Placebo"
64063|NCT02181387|B1|Baseline|Acetaminophen|"1000 mg every 6 hours during labor up to maximum 3 doses~Acetaminophen: administered every 6 hours by mouth up to 3 doses"
64064|NCT02181387|P2|Participant Flow|Placebo|"placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 3 doses~Placebo"
64065|NCT02181387|P1|Participant Flow|Acetaminophen|"1000 mg every 6 hours during labor up to maximum 3 doses~Acetaminophen: administered every 6 hours by mouth up to 3 doses"
64066|NCT02181387|O2|Outcome|Placebo|"placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 3 doses~Placebo"
64067|NCT02181387|O1|Outcome|Acetaminophen|"1000 mg every 6 hours during labor up to maximum 3 doses~Acetaminophen: administered every 6 hours by mouth up to 3 doses"
64068|NCT02181387|E2|Reported Event|Placebo|"placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 3 doses~Placebo"
64069|NCT02181387|E1|Reported Event|Acetaminophen|"1000 mg every 6 hours during labor up to maximum 3 doses~Acetaminophen: administered every 6 hours by mouth up to 3 doses"
64070|NCT02181140|B1|Baseline|EUS Guided FNA and Fine Needle Punction|"punction of endosonographically identified space-occupying process with aspirating fine needle and pro core fine needle in a randomized order~EUS guided FNA and fine needle punction: punction of a suspect area by a EUS guided fine needle as well as pro core fine needle to evacuate histology and smear biologics"
64071|NCT02181140|P1|Participant Flow|EUS Guided FNA and Fine Needle Punction|"punction of endosonographically identified space-occupying process with aspirating fine needle and pro core fine needle in a randomized order~EUS guided FNA and fine needle punction: punction of a suspect area by a EUS guided fine needle as well as pro core fine needle to evacuate histology and smear biologics"
64072|NCT02181140|O1|Outcome|EUS Guided FNA|EUS FNA of lesions with aspirating fine needle and pro core fine needle in a randomized order
64073|NCT02181140|O1|Outcome|EUS Guided Pro Core FNA|EUS guided Pro core FNA: Histology samples (not cytology)
64076|NCT02181127|B1|Baseline|Glucagon-only Bionic Pancreas|"Subjects will use the device every day and will fill the reservoir daily with glucagon or placebo (randomized, double blinded allocation for each day).~Glucagon-only Bionic Pancreas: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor."
64077|NCT02181127|P1|Participant Flow|Glucagon-only Bionic Pancreas|"Subjects will use the device every day and will fill the reservoir daily with glucagon or placebo (randomized, double blinded allocation for each day).~Glucagon-only Bionic Pancreas: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor."
64078|NCT02181127|O2|Outcome|Placebo|Glucagon-only Bionic Pancreas delivered placebo during 7 of the 14 days. The order of the placebo days was randomized in blocks of 2, with no more than 2 days in a row of placebo.
64079|NCT02181127|O1|Outcome|Glucagon-only Bionic Pancreas|Glucagon-only Bionic Pancreas delivered glucagon during 7 of the 14 days. The order of the glucagon days was randomized in blocks of 2, with no more than 2 days in a row of glucagon.
64080|NCT02181127|E1|Reported Event|Glucagon-only Bionic Pancreas|"Subjects will use the device every day and will fill the reservoir daily with glucagon or placebo (randomized, double blinded allocation for each day).~Glucagon-only Bionic Pancreas: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor."
64081|NCT02180893|B3|Baseline|Total|Total of all reporting groups
64082|NCT02180893|B2|Baseline|No Block|"Patients who did not receive PVB~Placebo Comparator: No block~Patients who did not receive PVB"
64083|NCT02180893|B1|Baseline|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valce surgery~Paravertebral Block: Paravertebral nerve block injection"
64084|NCT02180893|P2|Participant Flow|No Block|"Patients who did not receive PVB~Placebo Comparator: No block~Patients who did not receive PVB"
64085|NCT02180893|P1|Participant Flow|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valce surgery~Paravertebral Block: Paravertebral nerve block injection"
64086|NCT02180893|O2|Outcome|No Block|"Patients who did not receive PVB~Placebo Comparator: No block~Patients who did not receive PVB"
64087|NCT02180893|O1|Outcome|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valve surgery~Paravertebral Block: Paravertebral nerve block injection"
64088|NCT02180893|O2|Outcome|No Block|"Patients who did not receive PVB~Placebo Comparator: No block~Patients who did not receive PVB"
64089|NCT02180893|O1|Outcome|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valve surgery~Paravertebral Block: Paravertebral nerve block injection"
64090|NCT02180893|O2|Outcome|No Block|"Patients who did not receive PVB~Placebo Comparator: No block~Patients who did not receive PVB"
64091|NCT02180893|O1|Outcome|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valve surgery~Paravertebral Block: Paravertebral nerve block injection"
64092|NCT02180893|O2|Outcome|No Block|"Patients who did not receive PVB~Placebo Comparator: No block~Patients who did not receive PVB"
64093|NCT02180893|O1|Outcome|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valve surgery~Paravertebral Block: Paravertebral nerve block injection"
64094|NCT02180893|E2|Reported Event|No Block|"Patients who did not receive PVB~Placebo Comparator: No block~Patients who did not receive PVB"
64095|NCT02180893|E1|Reported Event|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valce surgery~Paravertebral Block: Paravertebral nerve block injection"
64096|NCT02180828|B3|Baseline|Total|Total of all reporting groups
64097|NCT02180828|B2|Baseline|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
64098|NCT02180828|B1|Baseline|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
64099|NCT02180828|P2|Participant Flow|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
64100|NCT02180828|P1|Participant Flow|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
64101|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
64102|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
64103|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
64104|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
64105|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
64106|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
64107|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
64108|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
64109|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
64110|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
64111|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
64349|NCT02178059|O2|Outcome|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation
64112|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
64113|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
64114|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
64115|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
64116|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
64117|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
64118|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
64119|NCT02180828|E2|Reported Event|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
64120|NCT02180828|E1|Reported Event|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
64121|NCT02180646|B3|Baseline|Total|Total of all reporting groups
64122|NCT02180646|B2|Baseline|High Protein Then High Carb Breakfast|A high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat) for 7 days, followed by a 7-day washout, followed by a high carbohydrate breakfast for 7 days
64123|NCT02180646|B1|Baseline|High Carb Then High Protein Breakfast|A high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat) for 7 days, followed by 7-day washout, followed by a high protein breakfast for 7 days
64124|NCT02180646|P2|Participant Flow|High Protein Then High Carb Breakfast|A high protein breakfast for 7 days, followed by a 7-day washout, followed a high carbohydrate breakfast for 7 days
64125|NCT02180646|P1|Participant Flow|High Carb Then High Protein Breakfast|A high carbohydrate breakfast for 7 days, followed by a 7-day washout, followed a high protein breakfast for 7 days
64126|NCT02180646|O2|Outcome|High Carbohydrate Breakfast|"a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
64127|NCT02180646|O1|Outcome|High Protein Breakfast|"a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
64128|NCT02180646|O2|Outcome|High Carbohydrate Breakfast|"a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
64129|NCT02180646|O1|Outcome|High Protein Breakfast|"a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
64130|NCT02180646|O2|Outcome|High Carbohydrate Breakfast|"a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
64131|NCT02180646|O1|Outcome|High Protein Breakfast|"a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
64132|NCT02180646|E2|Reported Event|High Carbohydrate Breakfast|"a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
64133|NCT02180646|E1|Reported Event|High Protein Breakfast|"a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
64134|NCT02180438|B1|Baseline|Open Label Prospective Single Arm Study of Stribild|Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
64135|NCT02180438|P1|Participant Flow|Open Label Prospective Single Arm Study of Stribild|Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
64136|NCT02180438|O1|Outcome|Open Label Prospective Single Arm Study of Stribild|Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
64137|NCT02180438|O1|Outcome|Open Label Prospective Single Arm Study of Stribild|Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
64138|NCT02180438|O1|Outcome|Open Label Prospective Single Arm Study of Stribild|Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
64139|NCT02180438|O1|Outcome|Open Label Prospective Single Arm Study of Stribild|Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
64140|NCT02180438|O1|Outcome|Open Label Prospective Single Arm Study of Stribild|Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
64141|NCT02180438|O1|Outcome|Open Label Prospective Single Arm Study of Stribild|Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
64142|NCT02180438|O1|Outcome|Open Label Prospective Single Arm Study of Stribild|Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
64143|NCT02180438|O1|Outcome|Open Label Prospective Single Arm Study of Stribild|Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
64144|NCT02180438|E1|Reported Event|Open Label Prospective Single Arm Study of Stribild|Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
64145|NCT02180230|B1|Baseline|Shorty Implants|"Brånemark System Mk III Shorty and/or NobelSpeedy Shorty~Shorty implants: Dental implant insertion to maxilla or mandible"
64146|NCT02180230|P1|Participant Flow|Shorty Implants|"Brånemark System Mk III Shorty and/or NobelSpeedy Shorty~Shorty implants: Dental implant insertion to maxilla or mandible"
64147|NCT02180230|O1|Outcome|Shorty Implants|"Brånemark System Mk III Shorty and NobelSpeedy Shorty~Shorty implants: Dental implant insertion to maxilla or mandible"
64148|NCT02180230|O1|Outcome|Shorty Implants|"Brånemark System Mk III Shorty and NobelSpeedy Shorty~Shorty implants: Dental implant insertion to maxilla or mandible"
64149|NCT02180230|E1|Reported Event|Shorty Implants|"Brånemark System Mk III Shorty and/or NobelSpeedy Shorty~Shorty implants: Dental implant insertion to maxilla or mandible"
64150|NCT02180061|B3|Baseline|Total|Total of all reporting groups
64153|NCT02180061|P2|Participant Flow|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
64154|NCT02180061|P1|Participant Flow|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, intravenously (IV) over 30 minutes on Day 1 of each 3-week dosing cycle (Q3W).
64155|NCT02180061|O2|Outcome|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
64156|NCT02180061|O1|Outcome|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
64157|NCT02180061|O2|Outcome|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
64158|NCT02180061|O1|Outcome|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
64159|NCT02180061|O2|Outcome|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
64160|NCT02180061|O1|Outcome|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
64161|NCT02180061|O2|Outcome|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
64162|NCT02180061|O1|Outcome|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
64163|NCT02180061|O2|Outcome|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
64164|NCT02180061|O1|Outcome|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
64165|NCT02180061|E2|Reported Event|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
64166|NCT02180061|E1|Reported Event|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
64167|NCT02179892|B3|Baseline|Total|Total of all reporting groups
64168|NCT02179892|B2|Baseline|Group 2-Bupivacaine and Dexamethasone IV|"Bupivacaine and Dexamethasone Injection was administered via TAP block procedure.~Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block."
64169|NCT02179892|B1|Baseline|Group 1-Exparel|"Bupivacaine Extended-Release Liposome Injection (Exparel) was administered via TAP block procedure~Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block"
64170|NCT02179892|P2|Participant Flow|Group 2-Bupivacaine and Dexamethasone IV|"Bupivacaine and Dexamethasone Injection were administered via TAP block procedure.~Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block."
64171|NCT02179892|P1|Participant Flow|Group 1-Exparel|"Bupivacaine Extended-Release Liposome Injection (Exparel) were administered via TAP block procedure~Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block."
64172|NCT02179892|O2|Outcome|Group 2-Bupivacaine and Dexamethasone IV|"Bupivacaine and Dexamethasone Injection was administered via TAP block procedure.~Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block."
64173|NCT02179892|O1|Outcome|Group 1-Exparel|"Bupivacaine Extended-Release Liposome Injection (Exparel) was administered via TAP block procedure~Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block"
64174|NCT02179892|O2|Outcome|Group 2-Bupivacaine and Dexamethasone IV|"Bupivacaine and Dexamethasone Injection was administered via TAP block procedure.~Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block."
64175|NCT02179892|O1|Outcome|Group 1-Exparel|"Bupivacaine Extended-Release Liposome Injection (Exparel) was administered via TAP block procedure~Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block"
64176|NCT02179892|O2|Outcome|Group 2-Bupivacaine and Dexamethasone IV|"Bupivacaine and Dexamethasone Injection was administered via TAP block procedure.~Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block."
64177|NCT02179892|O1|Outcome|Group 1-Exparel|"Bupivacaine Extended-Release Liposome Injection (Exparel) was administered via TAP block procedure~Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block"
64178|NCT02179892|O2|Outcome|Group 2-Bupivacaine and Dexamethasone IV|"Bupivacaine and Dexamethasone Injection was administered via TAP block procedure.~Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block."
64179|NCT02179892|O1|Outcome|Group 1-Exparel|"Bupivacaine Extended-Release Liposome Injection (Exparel) was administered via TAP block procedure~Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block"
64180|NCT02179892|E2|Reported Event|Group 2-Bupivacaine and Dexamethasone IV|"Bupivacaine and Dexamethasone Injection was administered via TAP block procedure.~Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block."
64181|NCT02179892|E1|Reported Event|Group 1-Exparel|"Bupivacaine Extended-Release Liposome Injection (Exparel) was administered via TAP block procedure~Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block"
64182|NCT02179424|B5|Baseline|Total|Total of all reporting groups
64183|NCT02179424|B4|Baseline|Group D|"Phone counseling (Motivational intervention) + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
64184|NCT02179424|B3|Baseline|Group C|"Phone counseling (Motivational intervention) + Health talk + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
64185|NCT02179424|B2|Baseline|Group B|"Face to Face counseling (Motivational intervention) + Booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
64186|NCT02179424|B1|Baseline|Group A|"Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS)~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
64187|NCT02179424|P4|Participant Flow|Phone Counseling + Booklet + SMS|"Phone counseling (Motivational intervention) + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
64188|NCT02179424|P3|Participant Flow|Phone Counseling + Health Talk + Booklet + SMS|"Phone counseling (Motivational intervention) + Health talk + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
64189|NCT02179424|P2|Participant Flow|Face-to-face Counseling + Booklet + SMS|"Face to Face counseling (Motivational intervention) + Booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
64190|NCT02179424|P1|Participant Flow|Health Talk + Workshop + Booklet + SMS|"Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS)~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
64191|NCT02179424|O4|Outcome|Group D|"Phone counseling (Motivational intervention) + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
64192|NCT02179424|O3|Outcome|Group C|"Phone counseling (Motivational intervention) + Health talk + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
64193|NCT02179424|O2|Outcome|Group B|"Face to Face counseling (Motivational intervention) + Booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
64194|NCT02179424|O1|Outcome|Group A|"Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS)~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
64195|NCT02179424|O4|Outcome|Group D|"Phone counseling (Motivational intervention) + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
64196|NCT02179424|O3|Outcome|Group C|"Phone counseling (Motivational intervention) + Health talk + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
64197|NCT02179424|O2|Outcome|Group B|"Face to Face counseling (Motivational intervention) + Booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
64198|NCT02179424|O1|Outcome|Group A|"Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS)~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
64199|NCT02179424|O1|Outcome|Employers' KAP|Employers' knowledge on smoking and quitting
64200|NCT02179424|E4|Reported Event|Group D|"Phone counseling (Motivational intervention) + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
64201|NCT02179424|E3|Reported Event|Group C|"Phone counseling (Motivational intervention) + Health talk + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
64202|NCT02179424|E2|Reported Event|Group B|"Face to Face counseling (Motivational intervention) + Booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
64203|NCT02179424|E1|Reported Event|Group A|"Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS)~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
64204|NCT02179398|B3|Baseline|Total|Total of all reporting groups
64205|NCT02179398|B2|Baseline|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: WBC count, band count and CRP determination.~(PCT and thus Lab-score blinded to the physician in charge of the patient).~Allocation to the control group"
64206|NCT02179398|B1|Baseline|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.~(WBC and band counts blinded to the physician in charge of the patient)~Allocation to the Lab-score group"
64207|NCT02179398|P2|Participant Flow|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: WBC count, band count and CRP determination.~(PCT and thus Lab-score blinded to the physician in charge of the patient).~Allocation to the control group"
64208|NCT02179398|P1|Participant Flow|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.~(WBC and band counts blinded to the physician in charge of the patient)~Allocation to the Lab-score group"
64209|NCT02179398|O2|Outcome|Patients < 3 Months Old|Patients allocated to the Lab-score group OR to the control group, aged less than 3 months-old.
64210|NCT02179398|O1|Outcome|Patients 0-3 Years Old|Patients allocated to the Lab-score group OR to the control group, aged 0 up to 36 months-old.
64211|NCT02179398|O2|Outcome|Patients < 3 Months Old|Patients allocated to the Lab-score group OR to the control group, aged less than 3 months-old.
64212|NCT02179398|O1|Outcome|Patients 0-3 Years Old|Patients allocated to the Lab-score group OR to the control group, aged 0 up to 36 months-old.
64213|NCT02179398|O2|Outcome|Patients < 3 Months Old|Patients allocated to the Lab-score group OR to the control group, aged less than 3 months-old.
64214|NCT02179398|O1|Outcome|Patients 0-3 Years Old|Patients allocated to the Lab-score group OR to the control group, aged 0 up to 36 months-old.
64215|NCT02179398|O2|Outcome|Patients < 3 Months Old|Patients allocated to the Lab-score group OR to the control group, aged less than 3 months-old.
64216|NCT02179398|O1|Outcome|Patients 0-3 Years Old|Patients allocated to the Lab-score group OR to the control group, aged 0 up to 36 months-old.
64217|NCT02179398|O2|Outcome|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: WBC count, band count and CRP determination.~(PCT and thus Lab-score blinded to the physician in charge of the patient).~Allocation to the control group"
64218|NCT02179398|O1|Outcome|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.~(WBC and band counts blinded to the physician in charge of the patient)~Allocation to the Lab-score group"
64219|NCT02179398|O2|Outcome|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: WBC count, band count and CRP determination.~(PCT and thus Lab-score blinded to the physician in charge of the patient).~Allocation to the control group"
64220|NCT02179398|O1|Outcome|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.~(WBC and band counts blinded to the physician in charge of the patient)~Allocation to the Lab-score group"
64221|NCT02179398|O2|Outcome|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: white blood cell (WBC) count, band count and C-Reactive Protein (CRP) determination.~(Procalcitonin (PCT) and thus Lab-score blinded to the physician in charge of the patient).~Allocation to the control group"
64222|NCT02179398|O1|Outcome|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.~(white blood cell (WBC) and band counts blinded to the physician in charge of the patient)~Allocation to the Lab-score group"
64223|NCT02179398|E2|Reported Event|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: WBC count, band count and CRP determination.~(PCT and thus Lab-score blinded to the physician in charge of the patient).~Allocation to the control group"
64224|NCT02179398|E1|Reported Event|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.~(WBC and band counts blinded to the physician in charge of the patient)~Allocation to the Lab-score group"
64225|NCT02178995|B3|Baseline|Total|Total of all reporting groups
64226|NCT02178995|B2|Baseline|Healthy Controls|Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.
64227|NCT02178995|B1|Baseline|Participants With Epilepsy|"Participants received three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time. Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed."
64228|NCT02178995|P9|Participant Flow|40mg, 20mg, Then Placebo (One Participant)|This study was originally intended to use 40mg, 20mg, and placebo doses rather than 20mg, 10mg, and placebo. This individual developed tachycardia (see adverse events) on the 40mg dose, and was withdrawn from the double-blind portion as a result. We removed the 40mg doses from this study and replaced them with 10mg doses. No other participant received a 40mg dose. This participant rejoined the open-label portion after consultation with his PCP due to significant perceived benefit from the MPH dose.
64229|NCT02178995|P8|Participant Flow|20mg, 10mg, Then Placebo - Double-blind|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
64230|NCT02178995|P7|Participant Flow|20mg, Placebo, Then 10mg (Double-blind)|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
64231|NCT02178995|P6|Participant Flow|Placebo, 10mg, Then 20mg (Double-blind)|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
64232|NCT02178995|P5|Participant Flow|Placebo, 20mg, Then 10mg (Double-blind|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
64290|NCT02178995|O1|Outcome|Participants With Epilepsy: Placebo|"Methylphenidate: Participants received blinded, single-dose capsules during either visit 2, 3, or 4. During one of these visits, they received the placebo capsule.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
64233|NCT02178995|P4|Participant Flow|10mg, Placebo, Then 20mg (Double-blind)|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
64234|NCT02178995|P3|Participant Flow|10mg, 20mg, Then Placebo (Double-blind)|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
64235|NCT02178995|P2|Participant Flow|Healthy Controls|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
64236|NCT02178995|P1|Participant Flow|Participants With Epilepsy (Open-label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After a four week treatment trial, their scores on the batteries and questionnaires were again assessed.
64237|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
64238|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
64239|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
64240|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
64241|NCT02178995|O3|Outcome|Participants With Epilepsy: Methylphenidate 20 mg|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 20 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
64242|NCT02178995|O2|Outcome|Participants With Epilepsy: Methylphenidate 10 mg Dose|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 10 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
64243|NCT02178995|O1|Outcome|Participants With Epilepsy: Placebo|"Methylphenidate: Participants received blinded, single-dose capsules during either visit 2, 3, or 4. During one of these visits, they received the placebo capsule.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
64244|NCT02178995|O3|Outcome|Participants With Epilepsy: Methylphenidate 20 mg|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 20 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
64245|NCT02178995|O2|Outcome|Participants With Epilepsy: Methylphenidate 10 mg Dose|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 10 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
64246|NCT02178995|O1|Outcome|Participants With Epilepsy: Placebo|"Methylphenidate: Participants received blinded, single-dose capsules during either visit 2, 3, or 4. During one of these visits, they received the placebo capsule.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
64291|NCT02178995|O3|Outcome|Participants With Epilepsy: Methylphenidate 20 mg|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 20 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
64350|NCT02178059|O1|Outcome|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation
64247|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
64248|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
64249|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
64250|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
64251|NCT02178995|O2|Outcome|Participants With Epilepsy (Open-label Portion)|Note: Because the QOLIE-89 is specific to epilepsy populations, most of its questions are not applicable to healthy controls, and therefore healthy controls did not complete the QOLIE-89.
64252|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
64253|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
64254|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
64255|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
64256|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
64257|NCT02178995|O2|Outcome|Participants With Epilepsy (Open-label Portion)|Note: Because the SSC is specific to medication side effects, healthy controls did not complete the questionnaire.
64258|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
64259|NCT02178995|O2|Outcome|Participants With Epilepsy (Open-label Portion)|Note: Because the questionnaire is specific to epilepsy populations, and the side-effects to AEDs, healthy controls did not complete the QOLIE-89.
64260|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
65327|NCT02171234|O5|Outcome|Placebo|PLC, Placebo
64261|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
64262|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
64263|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
64264|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
64265|NCT02178995|O2|Outcome|Participants With Epilepsy (Open-label Portion)|Note: Because the QOLIE-89 is specific to epilepsy populations, most of its questions are not applicable to healthy controls, and therefore healthy controls did not complete the QOLIE-89.
64266|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
64267|NCT02178995|O2|Outcome|Participants With Epilepsy (Double-blind Portion)|
64268|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
64269|NCT02178995|O3|Outcome|Participants With Epilepsy: Methylphenidate 20 mg|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 20 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
64270|NCT02178995|O2|Outcome|Participants With Epilepsy: Methylphenidate 10 mg Dose|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 10 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
64271|NCT02178995|O1|Outcome|Participants With Epilepsy: Placebo|"Methylphenidate: Participants received blinded, single-dose capsules during either visit 2, 3, or 4. During one of these visits, they received the placebo capsule.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
64272|NCT02178995|O2|Outcome|Participants With Epilepsy (Open-label Portion)|Note: Because the QOLIE-89 is specific to epilepsy populations, most of its questions are not applicable to healthy controls, and therefore healthy controls did not complete the QOLIE-89.
64273|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
64274|NCT02178995|O2|Outcome|Participants With Epilepsy (Open-label Portion)|
64292|NCT02178995|O2|Outcome|Participants With Epilepsy: Methylphenidate 10 mg Dose|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 10 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
64351|NCT02178059|O2|Outcome|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation
64275|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
64276|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
64277|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
64278|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
64279|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
64280|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
64281|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
64282|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
64283|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
64284|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
64285|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
64286|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
64287|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
64288|NCT02178995|O3|Outcome|Participants With Epilepsy: Methylphenidate 20 mg|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 20 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
64289|NCT02178995|O2|Outcome|Participants With Epilepsy: Methylphenidate 10 mg Dose|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 10 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
64293|NCT02178995|O1|Outcome|Participants With Epilepsy: Placebo|"Methylphenidate: Participants received blinded, single-dose capsules during either visit 2, 3, or 4. During one of these visits, they received the placebo capsule.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
64294|NCT02178995|O3|Outcome|Participants With Epilepsy: Methylphenidate 20 mg|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 20 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
64295|NCT02178995|O2|Outcome|Participants With Epilepsy: Methylphenidate 10 mg Dose|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 10 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
64296|NCT02178995|O1|Outcome|Participants With Epilepsy: Placebo|"Methylphenidate: Participants received blinded, single-dose capsules during either visit 2, 3, or 4. During one of these visits, they received the placebo capsule.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
64297|NCT02178995|E9|Reported Event|Healthy Controls|Healthy controls will complete the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but will not be exposed to study medication. They are included as a control group for the open-label phase of the study (visit 1 vs visit 5) only.
64298|NCT02178995|E8|Reported Event|40mg, 20mg, Then Placebo (One Participant)|This study was originally intended to use 40mg, 20mg, and placebo doses rather than 20mg, 10mg, and placebo. This individual developed tachycardia (see adverse events) on the 40mg dose, and was withdrawn from the double-blind portion as a result. We removed the 40mg doses from this study and replaced them with 10mg doses. No other participant received a 40mg dose. This participant rejoined the open-label portion after consultation with his PCP due to significant perceived benefit from the MPH dose.
64299|NCT02178995|E7|Reported Event|20mg, Placebo, Then 10mg (Double-blind)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order:~20mg of methylphenidate, Placebo, 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
64300|NCT02178995|E6|Reported Event|20mg, 10mg, Then Placebo (Double-blind)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order:~20mg of methylphenidate, 10mg of methylphenidate, Placebo.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
64301|NCT02178995|E5|Reported Event|10mg, Placebo, Then 20mg (Double-blind)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order:~10mg of methylphenidate, Placebo, 20mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
64302|NCT02178995|E4|Reported Event|10mg, 20mg, Then Placebo (Double-blind)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order:~10mg of methylphenidate, 20mg of methylphenidate, Placebo.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
64334|NCT02178540|E4|Reported Event|Open Label (>=18) Years Old|
64335|NCT02178540|E3|Reported Event|Open Label (11-17)Years Old|
64336|NCT02178540|E2|Reported Event|Total - All Participants|
64337|NCT02178540|E1|Reported Event|Open Label (6-10) Years Old|one dose (4 capsules) of matching placebo to Tobramycin inhalation powder hard capsule
64338|NCT02178059|B1|Baseline|Randomized Subjects|All randomized subjects
64339|NCT02178059|P2|Participant Flow|M2 First, Then M3|Sequence 2: M2 first, then M3
64340|NCT02178059|P1|Participant Flow|M3 First, Then M2|Sequence 1: M3 first then M2
64341|NCT02178059|O2|Outcome|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation
64758|NCT02175771|B9|Baseline|Total|Total of all reporting groups
64303|NCT02178995|E3|Reported Event|Placebo, 10mg, Then 20mg (Double-blind)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order:~Placebo, 10mg of methylphenidate, 20mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
64304|NCT02178995|E2|Reported Event|Placebo, 20mg, Then 10mg (Double-blind)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order:~Placebo, 20mg of methylphenidate, 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
64305|NCT02178995|E1|Reported Event|Participants With Epilepsy (Open-label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After a four week treatment trial, their scores on the batteries and questionnaires were again assessed.
64306|NCT02178787|B3|Baseline|Total|Total of all reporting groups
64307|NCT02178787|B2|Baseline|Non-diabetic Controls|Head-up tilt, vasoreactivity, sitting to standing-up
64308|NCT02178787|B1|Baseline|Type 2 Diabetics|Head-up tilt, vasoreactivity, sitting to standing-up
64309|NCT02178787|P2|Participant Flow|Non-diabetic Controls|Head-up tilt, vasoreactivity, sitting to standing-up
64310|NCT02178787|P1|Participant Flow|Type 2 Diabetics|Head-up tilt, vasoreactivity, sitting to standing-up
64311|NCT02178787|O2|Outcome|Non-diabetic Controls|Head-up tilt, vasoreactivity, standing up.
64312|NCT02178787|O1|Outcome|Type 2 Diabetes Mellitus|Head-up tilt, vasoreactivity, standing up.
64313|NCT02178787|O2|Outcome|Non-diabetic Controls|Head-up tilt, vasoreactivity, sitting to standing-up
64314|NCT02178787|O1|Outcome|Type 2 Diabetics|Head-up tilt, vasoreactivity, sitting to standing-up
64315|NCT02178787|E2|Reported Event|Non-diabetic Controls|Head-up tilt, vasoreactivity, sitting to standing-up
64316|NCT02178787|E1|Reported Event|Type 2 Diabetics|Head-up tilt, vasoreactivity, sitting to standing-up
64317|NCT02178696|B1|Baseline|Total Study Population|
64318|NCT02178696|P2|Participant Flow|"Active (Blinded) Placebo First Group"|"This arm gets a placebo that they don't know is a placebo (called Active), then has 2 scans performed (FMRI and PET), then a 2-3 day washout, and then gets a so-called inactive medication (which participants know is a placebo), and another pair of scans. Following these, participants receive 10 weeks of open-label antidepressant administration (Celexa as explained in intervention description). First line antidepressant will be Celexa unless not clinically indicated.~Placebo, identified as placebo to participants: White tablets~Celexa or other antidepressant as clinically indicated: Open label s-citalopram, 20 mg start up dose, increasing to 40 mg as clinically indicated; If prior non-response to this medication is noted by the patient, alternative treatments may include another first-line antidepressant:fluoxetine 20 mg; paroxetine up to 60 mg; sertraline up to 200 mg; bupropion up to 300 mg~Placebo, identifed to participants as Active medication: Blue Capsule"
64319|NCT02178696|P1|Participant Flow|Known Placebo First|"This arm gets a placebo that they know is a placebo (called inactive), then has 2 scans performed (FMRI and PET), then a 2-3 day washout, and then gets a so-called active medication (which is also actually a placebo), and another pair of scans. Following these, participants receive 10 weeks of open-label antidepressant administration (Celexa or alternative as explained in intervention description). First line antidepressant will be Celexa unless not clinically indicated.~Placebo, identified as placebo to participants: White tablets~Celexa or other antidepressant as clinically indicated: Open label s-citalopram, 20 mg start up dose, increasing to 40 mg as clinically indicated; If prior non-response to this medication is noted by the patient, alternative treatments may include another first-line antidepressant:fluoxetine 20 mg; paroxetine up to 60 mg; sertraline up to 200 mg; bupropion up to 300 mg~Placebo, identifed to participants as Active medication: Blue Capsule"
64320|NCT02178696|O1|Outcome|MADRS Scores During the Open-label Antidepressant Treatment|
64321|NCT02178696|O1|Outcome|Open-label Antidepressant Treatment After Placebo Experiment|
64322|NCT02178696|O2|Outcome|Inactive Placebo|
64323|NCT02178696|O1|Outcome|Active Placebo|
64324|NCT02178696|O2|Outcome|Inactive Placebo|
64325|NCT02178696|O1|Outcome|Active Placebo|
64326|NCT02178696|O1|Outcome|Average Regional Changes in D2/3 Binding (Inactive-Active Plac|Average regional changes in D2/3 binding potential from the Inactive to the Active placebo condition.
64327|NCT02178696|O1|Outcome|Changes in BOLD Responses During the MID After Placebo|Changes in BOLD response from the Inactive to the Active condition during the Monetary Incentive Delayed Task in the Nucleus Accumbens.
64328|NCT02178696|O1|Outcome|Changes in Mu-opioid Binding (Inactive -Active Placebo)|Average regional changes in mu-opioid binding potential from the Inactive to the Active Placebo Condition.
64329|NCT02178696|E2|Reported Event|Known Placebo|
64330|NCT02178696|E1|Reported Event|Placebo (Unknown)|
64331|NCT02178540|B1|Baseline|Open Label|one dose (4 capsules) of matching placebo to Tobramycin inhalation powder hard capsule
64332|NCT02178540|P1|Participant Flow|Open Label|one dose (4 capsules) of matching placebo to Tobramycin inhalation powder hard capsule
64333|NCT02178540|O1|Outcome|Open Label|one dose (4 capsules) of matching placebo to Tobramycin inhalation powder hard capsule
64352|NCT02178059|O1|Outcome|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation
64353|NCT02178059|E2|Reported Event|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation
64354|NCT02178059|E1|Reported Event|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation
64355|NCT02177266|B3|Baseline|Total|Total of all reporting groups
64356|NCT02177266|B2|Baseline|Colchicine|Colchicine 0.6mg bid will be given to study participants randomized to the study drug arm beginning at 48-72 hours prior to the planned cardiac surgery and then continued for a total of 30 days.
64357|NCT02177266|B1|Baseline|Placebo|A placebo pill (identical to the study drug Colchicine) will be given in a double-blinded fashion to study participants randomized to placebo.
64358|NCT02177266|P2|Participant Flow|Colchicine|Colchicine 0.6mg bid will be given to study participants randomized to the study drug arm beginning at 48-72 hours prior to the planned cardiac surgery and then continued for a total of 30 days.
64359|NCT02177266|P1|Participant Flow|Placebo|A placebo pill (identical to the study drug Colchicine) will be given in a double-blinded fashion to study participants randomized to placebo.
64360|NCT02177266|O2|Outcome|Colchicine|Colchicine 0.6mg bid will be given to study participants randomized to the study drug arm beginning at 48-72 hours prior to the planned cardiac surgery and then continued for a total of 30 days.
64361|NCT02177266|O1|Outcome|Placebo|A placebo pill (identical to the study drug Colchicine) will be given in a double-blinded fashion to study participants randomized to placebo.
64362|NCT02177266|O2|Outcome|Colchicine|Colchicine 0.6mg bid will be given to study participants randomized to the study drug arm beginning at 48-72 hours prior to the planned cardiac surgery and then continued for a total of 30 days.
64363|NCT02177266|O1|Outcome|Placebo|A placebo pill (identical to the study drug Colchicine) will be given in a double-blinded fashion to study participants randomized to placebo.
64364|NCT02177266|O2|Outcome|Colchicine|Colchicine 0.6mg bid will be given to study participants randomized to the study drug arm beginning at 48-72 hours prior to the planned cardiac surgery and then continued for a total of 30 days.
64365|NCT02177266|O1|Outcome|Placebo|A placebo pill (identical to the study drug Colchicine) will be given in a double-blinded fashion to study participants randomized to placebo.
64366|NCT02177266|E2|Reported Event|Colchicine|Colchicine 0.6mg bid will be given to study participants randomized to the study drug arm beginning at 48-72 hours prior to the planned cardiac surgery and then continued for a total of 30 days.
64367|NCT02177266|E1|Reported Event|Placebo|A placebo pill (identical to the study drug Colchicine) will be given in a double-blinded fashion to study participants randomized to placebo.
64368|NCT02177201|B3|Baseline|Total|Total of all reporting groups
64369|NCT02177201|B2|Baseline|Group 2|Intravenous 20 ml/kg/h 0.9% saline solution
64370|NCT02177201|B1|Baseline|Group 1|Intravenous 10 ml/kg/h 0.9% saline solution
64371|NCT02177201|P2|Participant Flow|Group 2|Intravenous 20 ml/kg/h 0.9% saline solution
64372|NCT02177201|P1|Participant Flow|Group 1|Intravenous 10 ml/kg/h 0.9% saline solution
64373|NCT02177201|O2|Outcome|20 ml/kg/h 0.9% Saline Solution|"Group 2, intravenous 20 ml/kg/h 0.9% saline solution~0.9 saline solution : After induction , IV access was established and children were randomly allocated to receive: 20 ml/kg/h 0.9% saline solution during intraoperatively"
64374|NCT02177201|O1|Outcome|10 ml/kg/h 0.9 %Saline Solution|"Group 1, intravenous 10 ml/kg/h 0.9% saline solution ,~0.9 % saline solution: After induction, IV access was established and children were randomly allocated to receive Group 1, 10 ml/kg/h 0.9% saline solution ;"
64375|NCT02177201|E2|Reported Event|Group 2 Intravenous 20ml/kg/h 0.9 %Saline Solution|Group 2, intravenous 20 ml/kg/h 0.9% saline solution. After induction, IV access was established and children were randomly allocated to receive one of two interventions: Group 1, 10 ml/kg/h 0.9% saline solution ; Group 2, 20 ml/kg/h 0.9% saline solution by intravenous during intraoperatively. In both groups no adverse events were observed.
64376|NCT02177201|E1|Reported Event|Group 1 Intravenous 10ml/kg/h 0.9 %Saline Solution|Group 1, intravenous 10 ml/kg/h 0.9% saline solution , After induction, IV access was established and children were randomly allocated to receive one of two interventions: Group 1, 10 ml/kg/h 0.9% saline solution ; Group 2, 20 ml/kg/h 0.9% saline solution by intravenous during intraoperatively. In both groups no adverse events were observed.
64377|NCT02177136|B4|Baseline|Total|Total of all reporting groups
64378|NCT02177136|B3|Baseline|Placebo|"Subjects randomized to placebo will take placebo for 24 weeks.~Placebo"
64379|NCT02177136|B2|Baseline|5 mg OCA Titrating to 10 mg OCA|"Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.~OCA"
64380|NCT02177136|B1|Baseline|1.5 mg OCA Titrating to 3 mg OCA|"Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.~OCA"
64381|NCT02177136|P3|Participant Flow|Placebo|"Subjects randomized to placebo will take placebo daily for 24 weeks.~Placebo"
64382|NCT02177136|P2|Participant Flow|5 mg OCA Titrating to 10 mg OCA|"Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.~OCA"
64383|NCT02177136|P1|Participant Flow|1.5 mg OCA Titrating to 3 mg OCA|"Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.~OCA"
64384|NCT02177136|O3|Outcome|Placebo|"Subjects randomized to placebo will take placebo for 24 weeks.~Placebo"
64385|NCT02177136|O2|Outcome|5 mg OCA Titrating to 10 mg OCA|"Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.~OCA"
64386|NCT02177136|O1|Outcome|1.5 mg OCA Titrating to 3 mg OCA|"Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.~OCA"
64387|NCT02177136|O3|Outcome|Placebo|"Subjects randomized to placebo will take placebo daily for 24 weeks.~Placebo"
64388|NCT02177136|O2|Outcome|5 mg OCA Titrating to 10 mg OCA|"Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.~OCA"
64389|NCT02177136|O1|Outcome|1.5 mg OCA Titrating to 3 mg OCA|"Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.~OCA"
64390|NCT02177136|O3|Outcome|Placebo|"Subjects randomized to placebo will take placebo for 24 weeks.~Placebo"
64391|NCT02177136|O2|Outcome|5 mg OCA Titrating to 10 mg OCA|"Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.~OCA"
64392|NCT02177136|O1|Outcome|1.5 mg OCA Titrating to 3 mg OCA|"Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.~OCA"
64393|NCT02177136|O3|Outcome|Placebo|"Subjects randomized to placebo will take placebo for 24 weeks.~Placebo"
64394|NCT02177136|O2|Outcome|5 mg OCA Titrating to 10 mg OCA|"Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.~OCA"
64395|NCT02177136|O1|Outcome|1.5 mg OCA Titrating to 3 mg OCA|"Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.~OCA"
64396|NCT02177136|O3|Outcome|Placebo|"Subjects randomized to placebo will take placebo for 24 weeks.~Placebo"
64397|NCT02177136|O2|Outcome|5 mg OCA Titrating to 10 mg OCA|"Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.~OCA"
64398|NCT02177136|O1|Outcome|1.5 mg OCA Titrating to 3 mg OCA|"Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.~OCA"
64399|NCT02177136|O3|Outcome|Placebo|"Subjects randomized to placebo will take placebo for 24 weeks.~Placebo"
64400|NCT02177136|O2|Outcome|5 mg OCA Titrating to 10 mg OCA|"Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.~OCA"
64401|NCT02177136|O1|Outcome|1.5 mg OCA Titrating to 3 mg OCA|"Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.~OCA"
64402|NCT02177136|O3|Outcome|Placebo|"Subjects randomized to placebo will take placebo daily for 24 weeks.~Placebo"
64403|NCT02177136|O2|Outcome|5 mg OCA Titrating to 10 mg OCA|"Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.~OCA"
64404|NCT02177136|O1|Outcome|1.5 mg OCA Titrating to 3 mg OCA|"Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.~OCA"
64405|NCT02177136|O3|Outcome|Placebo|"Subjects randomized to placebo will take placebo daily for 24 weeks.~Placebo"
64406|NCT02177136|O2|Outcome|5 mg OCA Titrating to 10 mg OCA|"Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.~OCA"
64407|NCT02177136|O1|Outcome|1.5 mg OCA Titrating to 3 mg OCA|"Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.~OCA"
64408|NCT02177136|E3|Reported Event|Placebo|"Subjects randomized to placebo will take placebo daily for 24 weeks.~Placebo"
64409|NCT02177136|E2|Reported Event|5 mg OCA Titrating to 10 mg OCA|"Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.~OCA"
64410|NCT02177136|E1|Reported Event|1.5 mg OCA Titrating to 3 mg OCA|"Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.~OCA"
64411|NCT02177032|B5|Baseline|Total|Total of all reporting groups
64412|NCT02177032|B4|Baseline|2-sites, TRC WITH HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
64413|NCT02177032|B3|Baseline|2-sites, TRC WITHOUT HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the “2-sites, TRC”, updated Thai Red Cross regimen.
64414|NCT02177032|B2|Baseline|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
64415|NCT02177032|B1|Baseline|4-sites, 1-week WITHOUT HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
64416|NCT02177032|P4|Participant Flow|2-sites, TRC WITH HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
64417|NCT02177032|P3|Participant Flow|2-sites, TRC WITHOUT HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the “2-sites, TRC”, updated Thai Red Cross regimen
64418|NCT02177032|P2|Participant Flow|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
64419|NCT02177032|P1|Participant Flow|4-sites, 1-week WITHOUT HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
64420|NCT02177032|O2|Outcome|2-sites, TRC WITH HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen, with or without HRIG administered on day 1
64421|NCT02177032|O1|Outcome|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
64890|NCT02175121|O3|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64422|NCT02177032|O2|Outcome|2-sites TRC WITH HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen, with or without HRIG administered on day 1
64423|NCT02177032|O1|Outcome|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
64424|NCT02177032|O4|Outcome|2-sites, TRC WITH HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
64425|NCT02177032|O3|Outcome|2-sites, TRC WITHOUT HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the “2-sites, TRC”, updated Thai Red Cross regimen
64426|NCT02177032|O2|Outcome|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
64427|NCT02177032|O1|Outcome|4-sites, 1-week WITHOUT HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
64428|NCT02177032|O4|Outcome|2-sites, TRC WITH HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
64429|NCT02177032|O3|Outcome|2-sites, TRC WITHOUT HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the “2-sites, TRC”, updated Thai Red Cross regimen.
64430|NCT02177032|O2|Outcome|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
64431|NCT02177032|O1|Outcome|4-sites, 1-week WITHOUT HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
64432|NCT02177032|O2|Outcome|2-sites, TRC Without HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the “2-sites, TRC”, updated Thai Red Cross regimen.
64433|NCT02177032|O1|Outcome|4-sites, 1-week Without HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
64434|NCT02177032|O2|Outcome|2-sites, TRC Without HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the “2-sites, TRC”, updated Thai Red Cross regimen.
64435|NCT02177032|O1|Outcome|4-sites, 1-week Without HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
64436|NCT02177032|O2|Outcome|4-sites, 1-week WITHOUT HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
64437|NCT02177032|O1|Outcome|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
64438|NCT02177032|O2|Outcome|4-sites, 1-week WITHOUT HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
64439|NCT02177032|O1|Outcome|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen with HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
64440|NCT02177032|O2|Outcome|TOTAL 2-sites, TRC|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen, with or without HRIG administered on day 1
64441|NCT02177032|O1|Outcome|TOTAL 4-sites, 1-week|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8) with or without HRIG administration on day 1
64442|NCT02177032|O2|Outcome|TOTAL 2-sites, TRC|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen, with or without HRIG administered on day 1
64443|NCT02177032|O1|Outcome|TOTAL 4-sites, 1-week|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8) with or without HRIG administration on day 1
64444|NCT02177032|O2|Outcome|TOTAL 2-sites, TRC|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen, with or without HRIG administered on day 1
64445|NCT02177032|O1|Outcome|TOTAL 4-sites, 1-week|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8) with or without HRIG administration on day 1
64446|NCT02177032|O2|Outcome|TOTAL 2-sites, TRC|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen, with or without HRIG administered on day 1
64447|NCT02177032|O1|Outcome|TOTAL 4-sites, 1-week|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen with and without HRIG administered on day 1
64448|NCT02177032|E4|Reported Event|2-sites, TRC WITH HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
64449|NCT02177032|E3|Reported Event|2-sites, TRC WITHOUT HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the “2-sites, TRC”, updated Thai Red Cross regimen.
64450|NCT02177032|E2|Reported Event|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
64451|NCT02177032|E1|Reported Event|4-sites, 1-week WITHOUT HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
64452|NCT02176837|B1|Baseline|Sodium Nitrite|64 nmol/min/kg sodium nitrite
64453|NCT02176837|P1|Participant Flow|Sodium Nitrite|64 nmol/min/kg sodium nitrite
64454|NCT02176837|O1|Outcome|Sodium Nitrite|64 nmol/min/kg sodium nitrite
64455|NCT02176837|E1|Reported Event|Sodium Nitrite|64 nmol/min/kg sodium nitrite
64456|NCT02176655|B1|Baseline|Cross-Over Group|"Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.~One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule or one placebo capsule to be taken after the onset of a delayed alcohol induced headache."
64457|NCT02176655|P1|Participant Flow|All Study Participants|"Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.~One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule or one placebo capsule to be taken after the onset of a delayed alcohol induced headache."
64458|NCT02176655|O2|Outcome|Placebo|"One placebo capsule to match taken after the onset of a delayed alcohol induced headache.~Placebo"
64459|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.~Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
64460|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.~Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
64461|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.~Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
64462|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.~Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
64463|NCT02176655|O2|Outcome|Placebo|"One placebo capsule to match taken after the onset of a delayed alcohol induced headache.~Placebo"
64464|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.~Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
64465|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.~Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
64466|NCT02176655|O2|Outcome|Placebo|"One placebo capsule to match taken after the onset of a delayed alcohol induced headache.~Placebo"
64467|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.~Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
64468|NCT02176655|O2|Outcome|Placebo|"One placebo capsule to match taken after the onset of a delayed alcohol induced headache.~Placebo"
64469|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.~Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
64470|NCT02176655|O2|Outcome|Placebo|"One placebo capsule to match taken after the onset of a delayed alcohol induced headache.~Placebo"
64471|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.~Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
64472|NCT02176655|O2|Outcome|Placebo|"One placebo capsule to match taken after the onset of a delayed alcohol induced headache.~Placebo"
64473|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.~Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
64474|NCT02176655|O2|Outcome|Placebo|"One placebo capsule to match taken after the onset of a delayed alcohol induced headache.~Placebo"
64475|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.~Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
64476|NCT02176655|E1|Reported Event|All Study Participants|"Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.~One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule or one placebo capsule to be taken after the onset of a delayed alcohol induced headache."
64477|NCT02176642|B3|Baseline|Total|Total of all reporting groups
64478|NCT02176642|B2|Baseline|Placebo Plus PTNS|"Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks~Placebo: Tablet taken by mouth daily for 6 weeks"
64479|NCT02176642|B1|Baseline|Oxybutynin Plus PTNS|"Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks"
64480|NCT02176642|P2|Participant Flow|Placebo Plus PTNS|"Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks~Placebo: Tablet taken by mouth daily for 6 weeks"
64481|NCT02176642|P1|Participant Flow|Oxybutynin Plus PTNS|"Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks"
64482|NCT02176642|O2|Outcome|Placebo Plus PTNS|"Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks~Placebo: Tablet taken by mouth daily for 6 weeks"
64483|NCT02176642|O1|Outcome|Oxybutynin Plus PTNS|"Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks"
64484|NCT02176642|O2|Outcome|Placebo Plus PTNS|"Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks~Placebo: Tablet taken by mouth daily for 6 weeks"
64485|NCT02176642|O1|Outcome|Oxybutynin Plus PTNS|"Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks"
64486|NCT02176642|O2|Outcome|Placebo Plus PTNS|"Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks~Placebo: Tablet taken by mouth daily for 6 weeks"
64487|NCT02176642|O1|Outcome|Oxybutynin Plus PTNS|"Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks"
64488|NCT02176642|O2|Outcome|Placebo Plus PTNS|"Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks~Placebo: Tablet taken by mouth daily for 6 weeks"
64489|NCT02176642|O1|Outcome|Oxybutynin Plus PTNS|"Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks"
64490|NCT02176642|O2|Outcome|Placebo Plus PTNS|"Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks~Placebo: Tablet taken by mouth daily for 6 weeks"
64491|NCT02176642|O1|Outcome|Oxybutynin Plus PTNS|"Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks"
64492|NCT02176642|O2|Outcome|Placebo Plus PTNS|"Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks~Placebo: Tablet taken by mouth daily for 6 weeks"
64493|NCT02176642|O1|Outcome|Oxybutynin Plus PTNS|"Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks"
64494|NCT02176642|O2|Outcome|Placebo Plus PTNS|"Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks~Placebo: Tablet taken by mouth daily for 6 weeks"
64495|NCT02176642|O1|Outcome|Oxybutynin Plus PTNS|"Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks"
64496|NCT02176642|O2|Outcome|Placebo Plus PTNS|"Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks~Placebo: Tablet taken by mouth daily for 6 weeks"
64497|NCT02176642|O1|Outcome|Oxybutynin Plus PTNS|"Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks"
64498|NCT02176642|O2|Outcome|Placebo Plus PTNS|"Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks~Placebo: Tablet taken by mouth daily for 6 weeks"
64499|NCT02176642|O1|Outcome|Oxybutynin Plus PTNS|"Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks"
64500|NCT02176642|E2|Reported Event|Placebo Plus PTNS|"Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks~Placebo: Tablet taken by mouth daily for 6 weeks"
64501|NCT02176642|E1|Reported Event|Oxybutynin Plus PTNS|"Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks"
64502|NCT02176525|B9|Baseline|Total|Total of all reporting groups
64503|NCT02176525|B8|Baseline|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64504|NCT02176525|B7|Baseline|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64505|NCT02176525|B6|Baseline|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64506|NCT02176525|B5|Baseline|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64507|NCT02176525|B4|Baseline|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64508|NCT02176525|B3|Baseline|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64509|NCT02176525|B2|Baseline|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64510|NCT02176525|B1|Baseline|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64511|NCT02176525|P8|Participant Flow|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64512|NCT02176525|P7|Participant Flow|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64513|NCT02176525|P6|Participant Flow|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64514|NCT02176525|P5|Participant Flow|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64515|NCT02176525|P4|Participant Flow|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64516|NCT02176525|P3|Participant Flow|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64517|NCT02176525|P2|Participant Flow|DBV 100mg Fibrosis|Deleobuvir (DBV) 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64518|NCT02176525|P1|Participant Flow|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64519|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64520|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64521|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64522|NCT02176525|O4|Outcome|DBV 400mg|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days. Subgroup of patients in fibrosis and in cirrhosis presented in one arm.
64523|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64524|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64525|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64526|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64527|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64528|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64529|NCT02176525|O4|Outcome|DBV 400mg|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days. Subgroup of patients in fibrosis and in cirrhosis presented in one arm.
64530|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64531|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64532|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64533|NCT02176525|O8|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64534|NCT02176525|O7|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64535|NCT02176525|O6|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64536|NCT02176525|O5|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64537|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64538|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64539|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64540|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64541|NCT02176525|O8|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64542|NCT02176525|O7|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64543|NCT02176525|O6|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64544|NCT02176525|O5|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64545|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64546|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64547|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64548|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64549|NCT02176525|O8|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64550|NCT02176525|O7|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64551|NCT02176525|O6|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64552|NCT02176525|O5|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64553|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64554|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64555|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64556|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64557|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64558|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64559|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64560|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64561|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64562|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64563|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64564|NCT02176525|O8|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
65634|NCT02170025|O2|Outcome|Placebo|Participants received matching placebo tid
64565|NCT02176525|O7|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64566|NCT02176525|O6|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64567|NCT02176525|O5|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64568|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64569|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64570|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64571|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64572|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64573|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64574|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64575|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64576|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64577|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64578|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64579|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64580|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64581|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64582|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64583|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64584|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64585|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64586|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64587|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64588|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64589|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64590|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64591|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64592|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64593|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64594|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64595|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64596|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64597|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64598|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64599|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64600|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64601|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64602|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64603|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64604|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64605|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64606|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64607|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64608|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64609|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64610|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64611|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64612|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64613|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64614|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64615|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64616|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64617|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64618|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64619|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64620|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64621|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64622|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64623|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64624|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64625|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64626|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64627|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64628|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64629|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64630|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64631|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64632|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64633|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64634|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64635|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64636|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64637|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64638|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64639|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64640|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64641|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64642|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64643|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64644|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64645|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64646|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64647|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64648|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64649|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64650|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64651|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64652|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64653|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64654|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64655|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64656|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64657|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64658|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64659|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64660|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64661|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64662|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64663|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64664|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64665|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64666|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64667|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64668|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64669|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64670|NCT02176525|O8|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64671|NCT02176525|O7|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64672|NCT02176525|O6|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64673|NCT02176525|O5|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64674|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64675|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64676|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64677|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64678|NCT02176525|O8|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64679|NCT02176525|O7|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64680|NCT02176525|O6|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64681|NCT02176525|O5|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64682|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64683|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64684|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64685|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64686|NCT02176525|E8|Reported Event|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64687|NCT02176525|E7|Reported Event|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64688|NCT02176525|E6|Reported Event|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64689|NCT02176525|E5|Reported Event|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
64690|NCT02176525|E4|Reported Event|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64691|NCT02176525|E3|Reported Event|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64692|NCT02176525|E2|Reported Event|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64693|NCT02176525|E1|Reported Event|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
64694|NCT02176421|B1|Baseline|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
64695|NCT02176421|P1|Participant Flow|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
64696|NCT02176421|O1|Outcome|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
64697|NCT02176421|O1|Outcome|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
64698|NCT02176421|O1|Outcome|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
64699|NCT02176421|O1|Outcome|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
64700|NCT02176421|O1|Outcome|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
64701|NCT02176421|O1|Outcome|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
64702|NCT02176421|E1|Reported Event|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
64703|NCT02176356|B1|Baseline|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
64704|NCT02176356|P1|Participant Flow|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
64705|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
64706|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
64707|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
64708|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
65748|NCT02169453|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
64709|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
64710|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
64711|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
64712|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
64713|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
64714|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
64715|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
64716|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
64717|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
64718|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
64719|NCT02176356|E1|Reported Event|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
64720|NCT02176343|B1|Baseline|ReSTOR Toric +2.5|AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
64721|NCT02176343|P1|Participant Flow|ReSTOR Toric +2.5|AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lens (IOL)
64722|NCT02176343|O1|Outcome|ReSTOR Toric +2.5|AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
64723|NCT02176343|O1|Outcome|ReSTOR Toric +2.5|AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
64724|NCT02176343|O1|Outcome|ReSTOR Toric +2.5|AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
64725|NCT02176343|O1|Outcome|ReSTOR Toric +2.5|AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
64726|NCT02176343|O1|Outcome|ReSTOR Toric +2.5|AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
64727|NCT02176343|O1|Outcome|ReSTOR Toric +2.5|AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
64728|NCT02176343|O1|Outcome|ReSTOR Toric +2.5|AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
64729|NCT02176343|O1|Outcome|ReSTOR Toric +2.5|AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
64730|NCT02176343|E1|Reported Event|ReSTOR Toric +2.5|All subjects implanted with AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
64731|NCT02176018|B3|Baseline|Total|Total of all reporting groups
64732|NCT02176018|B2|Baseline|Placebo|"One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Placebo"
65749|NCT02169453|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
64733|NCT02176018|B1|Baseline|Nuedexta|"One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Dextromethorphan and quinidine"
64734|NCT02176018|P2|Participant Flow|Placebo|"One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Placebo"
64735|NCT02176018|P1|Participant Flow|Nuedexta|"One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Dextromethorphan and quinidine"
64736|NCT02176018|O2|Outcome|Placebo|"One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Placebo"
64737|NCT02176018|O1|Outcome|Nuedexta|"One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Dextromethorphan and quinidine"
64738|NCT02176018|O2|Outcome|Placebo|"One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Placebo"
64739|NCT02176018|O1|Outcome|Nuedexta|"One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Dextromethorphan and quinidine"
64740|NCT02176018|O2|Outcome|Placebo|"One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Placebo"
64741|NCT02176018|O1|Outcome|Nuedexta|"One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Dextromethorphan and quinidine"
64742|NCT02176018|O2|Outcome|Placebo|"One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Placebo"
64743|NCT02176018|O1|Outcome|Nuedexta|"One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Dextromethorphan and quinidine"
64744|NCT02176018|O2|Outcome|Placebo|"One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Placebo"
64745|NCT02176018|O1|Outcome|Nuedexta|"One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Dextromethorphan and quinidine"
64746|NCT02176018|O2|Outcome|Placebo|"One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Placebo"
64747|NCT02176018|O1|Outcome|Nuedexta|"One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Dextromethorphan and quinidine"
64748|NCT02176018|O2|Outcome|Placebo|"One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Placebo"
64749|NCT02176018|O1|Outcome|Nuedexta|"One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Dextromethorphan and quinidine"
64750|NCT02176018|O2|Outcome|Placebo|"One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Placebo"
64751|NCT02176018|O1|Outcome|Nuedexta|"One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Dextromethorphan and quinidine"
64752|NCT02176018|O2|Outcome|Placebo|"One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Placebo"
64753|NCT02176018|O1|Outcome|Nuedexta|"One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Dextromethorphan and quinidine"
64754|NCT02176018|O2|Outcome|Placebo|"One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Placebo"
64755|NCT02176018|O1|Outcome|Nuedexta|"One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Dextromethorphan and quinidine"
64756|NCT02176018|E2|Reported Event|Placebo|"One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Placebo"
64757|NCT02176018|E1|Reported Event|Nuedexta|"One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Dextromethorphan and quinidine"
64759|NCT02175771|B8|Baseline|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64760|NCT02175771|B7|Baseline|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64761|NCT02175771|B6|Baseline|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64762|NCT02175771|B5|Baseline|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64763|NCT02175771|B4|Baseline|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64764|NCT02175771|B3|Baseline|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64765|NCT02175771|B2|Baseline|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64766|NCT02175771|B1|Baseline|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64767|NCT02175771|P9|Participant Flow|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64768|NCT02175771|P8|Participant Flow|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64769|NCT02175771|P7|Participant Flow|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64770|NCT02175771|P6|Participant Flow|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64771|NCT02175771|P5|Participant Flow|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64772|NCT02175771|P4|Participant Flow|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64773|NCT02175771|P3|Participant Flow|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
65328|NCT02171234|O4|Outcome|Group 4 - BIA 2-093 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 1200mg
64774|NCT02175771|P2|Participant Flow|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64775|NCT02175771|P1|Participant Flow|Enrolled Patients|During the run-in period, patients continued using their current asthma medications (ie, inhaled corticosteroid and/or other controller therapies) except for their short acting beta2-agonist (SABA), which was replaced by the sponsor-provided study rescue medication.
64776|NCT02175771|O8|Outcome|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64777|NCT02175771|O7|Outcome|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64778|NCT02175771|O6|Outcome|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64779|NCT02175771|O5|Outcome|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64780|NCT02175771|O4|Outcome|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64781|NCT02175771|O3|Outcome|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64782|NCT02175771|O2|Outcome|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64783|NCT02175771|O1|Outcome|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64784|NCT02175771|O8|Outcome|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64785|NCT02175771|O7|Outcome|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64786|NCT02175771|O6|Outcome|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64787|NCT02175771|O5|Outcome|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64788|NCT02175771|O4|Outcome|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64836|NCT02175745|E1|Reported Event|Diagnostic (FDOPA-PET/CT or PET/MRI)|Patients receive 18F-FDOPA intravenously (IV) and then undergo PET/CT or PET/MRI 10-30 minutes later. After completion of study, patients are followed up at 24 hours and at 1 week.
65750|NCT02169453|E4|Reported Event|Placebo|Placebo, PLC
64789|NCT02175771|O3|Outcome|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64790|NCT02175771|O2|Outcome|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64791|NCT02175771|O1|Outcome|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64792|NCT02175771|O8|Outcome|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64793|NCT02175771|O7|Outcome|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64794|NCT02175771|O6|Outcome|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64795|NCT02175771|O5|Outcome|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64796|NCT02175771|O4|Outcome|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64797|NCT02175771|O3|Outcome|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64798|NCT02175771|O2|Outcome|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64799|NCT02175771|O1|Outcome|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64800|NCT02175771|O8|Outcome|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64801|NCT02175771|O7|Outcome|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64802|NCT02175771|O6|Outcome|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64803|NCT02175771|O5|Outcome|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64837|NCT02175368|B1|Baseline|Adhese One F Upgrade|"Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol).~Adhese One F Upgrade"
64804|NCT02175771|O4|Outcome|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64805|NCT02175771|O3|Outcome|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64806|NCT02175771|O2|Outcome|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64807|NCT02175771|O1|Outcome|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64808|NCT02175771|O8|Outcome|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64809|NCT02175771|O7|Outcome|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64810|NCT02175771|O6|Outcome|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64811|NCT02175771|O5|Outcome|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64812|NCT02175771|O4|Outcome|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64813|NCT02175771|O3|Outcome|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64814|NCT02175771|O2|Outcome|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64815|NCT02175771|O1|Outcome|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64816|NCT02175771|O8|Outcome|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64817|NCT02175771|O7|Outcome|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64818|NCT02175771|O6|Outcome|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64838|NCT02175368|P1|Participant Flow|Adhese One F Upgrade|"Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol).~Adhese One F Upgrade"
64819|NCT02175771|O5|Outcome|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64820|NCT02175771|O4|Outcome|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64821|NCT02175771|O3|Outcome|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64822|NCT02175771|O2|Outcome|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64823|NCT02175771|O1|Outcome|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64824|NCT02175771|E8|Reported Event|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64825|NCT02175771|E7|Reported Event|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64826|NCT02175771|E6|Reported Event|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64827|NCT02175771|E5|Reported Event|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64828|NCT02175771|E4|Reported Event|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64829|NCT02175771|E3|Reported Event|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64830|NCT02175771|E2|Reported Event|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64831|NCT02175771|E1|Reported Event|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
64832|NCT02175745|B1|Baseline|Diagnostic (FDOPA-PET/CT or PET/MRI)|Patients receive 18F-FDOPA intravenously (IV) and then undergo PET/CT or PET/MRI 10-30 minutes later. After completion of study, patients are followed up at 24 hours and at 1 week.
64833|NCT02175745|P1|Participant Flow|Diagnostic (FDOPA-PET/CT or PET/MRI)|Patients receive 18F-FDOPA intravenously (IV) and then undergo PET/CT or PET/MRI 10-30 minutes later. After completion of study, patients are followed up at 24 hours and at 1 week.
64834|NCT02175745|O1|Outcome|Diagnostic (FDOPA-PET/CT or PET/MRI)|Patients receive 18F-FDOPA intravenously (IV) and then undergo PET/CT or PET/MRI 10-30 minutes later. After completion of study, patients are followed up at 24 hours and at 1 week.
64835|NCT02175745|O1|Outcome|Diagnostic (FDOPA-PET/CT or PET/MRI)|Patients receive 18F-FDOPA intravenously (IV) and then undergo PET/CT or PET/MRI 10-30 minutes later. After completion of study, patients are followed up at 24 hours and at 1 week.
64839|NCT02175368|O1|Outcome|Adhese One F Upgrade|"Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol).~Adhese One F Upgrade"
64840|NCT02175368|E1|Reported Event|Adhese One F Upgrade|"Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol).~Adhese One F Upgrade"
64841|NCT02175212|B3|Baseline|Total|Total of all reporting groups
64842|NCT02175212|B2|Baseline|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
64843|NCT02175212|B1|Baseline|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
64844|NCT02175212|P2|Participant Flow|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
64845|NCT02175212|P1|Participant Flow|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
64846|NCT02175212|O2|Outcome|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
64847|NCT02175212|O1|Outcome|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
64848|NCT02175212|O2|Outcome|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
64849|NCT02175212|O1|Outcome|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
64850|NCT02175212|O2|Outcome|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
64851|NCT02175212|O1|Outcome|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
64852|NCT02175212|O2|Outcome|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
64853|NCT02175212|O1|Outcome|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
64854|NCT02175212|O2|Outcome|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
65751|NCT02169453|E3|Reported Event|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
64855|NCT02175212|O1|Outcome|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
64856|NCT02175212|E2|Reported Event|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
64857|NCT02175212|E1|Reported Event|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
64858|NCT02175199|B3|Baseline|Total|Total of all reporting groups
64859|NCT02175199|B2|Baseline|FreshLook COLORBLENDS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement.
64860|NCT02175199|B1|Baseline|AIR OPTIX COLORS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
64861|NCT02175199|P2|Participant Flow|FreshLook COLORBLENDS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement.
64862|NCT02175199|P1|Participant Flow|AIR OPTIX COLORS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
64863|NCT02175199|O2|Outcome|FreshLook COLORBLENDS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement.
64864|NCT02175199|O1|Outcome|AIR OPTIX COLORS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
64865|NCT02175199|O1|Outcome|AIR OPTIX COLORS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
64866|NCT02175199|O1|Outcome|AIR OPTIX COLORS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
64867|NCT02175199|E3|Reported Event|FreshLook COLORBLENDS|Includes all eyes exposed to FreshLook® COLORBLENDS® contact lenses
64868|NCT02175199|E2|Reported Event|AIR OPTIX COLORS|Includes all eyes exposed to AIR OPTIX® COLORS contact lenses
64869|NCT02175199|E1|Reported Event|Pre-treatment|Includes all subjects prior to the exposure to the investigational or control products
64870|NCT02175121|B6|Baseline|Total|Total of all reporting groups
64871|NCT02175121|B5|Baseline|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64872|NCT02175121|B4|Baseline|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64873|NCT02175121|B3|Baseline|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64874|NCT02175121|B2|Baseline|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64875|NCT02175121|B1|Baseline|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
64876|NCT02175121|P5|Participant Flow|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64877|NCT02175121|P4|Participant Flow|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64878|NCT02175121|P3|Participant Flow|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64879|NCT02175121|P2|Participant Flow|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64880|NCT02175121|P1|Participant Flow|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
64881|NCT02175121|O4|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64882|NCT02175121|O3|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64883|NCT02175121|O2|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64884|NCT02175121|O1|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64885|NCT02175121|O4|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64886|NCT02175121|O3|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64887|NCT02175121|O2|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64888|NCT02175121|O1|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64889|NCT02175121|O4|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64891|NCT02175121|O2|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64892|NCT02175121|O1|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64893|NCT02175121|O4|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64894|NCT02175121|O3|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64895|NCT02175121|O2|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64896|NCT02175121|O1|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64897|NCT02175121|O4|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64898|NCT02175121|O3|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64899|NCT02175121|O2|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64900|NCT02175121|O1|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64901|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64902|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64903|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64904|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64905|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
64906|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64907|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64908|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64909|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64910|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
64911|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64912|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64913|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64914|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64915|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
64916|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64917|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64918|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64919|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64920|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
64921|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64922|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64923|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64924|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64925|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
64926|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64927|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64928|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64929|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64930|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
65329|NCT02171234|O3|Outcome|Group 3 - BIA 2-093 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 800mg
64931|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64932|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64933|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64934|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64935|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
64936|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64937|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64938|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64939|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64940|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
64941|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64942|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64943|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64944|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64945|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
64946|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64947|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64948|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64949|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64950|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
64951|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64952|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64953|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64954|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64955|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
64956|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64957|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64958|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64959|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64960|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
64961|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64962|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64963|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64964|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64965|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
64966|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64967|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64968|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64969|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64970|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
65330|NCT02171234|O2|Outcome|Group 2 - BIA 2-093 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 400mg
64971|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64972|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64973|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64974|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64975|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
64976|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64977|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64978|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64979|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64980|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
64981|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64982|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64983|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64984|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64985|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
64986|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64987|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64988|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64989|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64990|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
64991|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64992|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64993|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64994|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64995|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
64996|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
64997|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
64998|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
64999|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
65000|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
65001|NCT02175121|E5|Reported Event|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
65002|NCT02175121|E4|Reported Event|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
65003|NCT02175121|E3|Reported Event|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
65004|NCT02175121|E2|Reported Event|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
65005|NCT02175121|E1|Reported Event|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
65006|NCT02173769|B1|Baseline|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
65007|NCT02173769|P1|Participant Flow|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
65008|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
65009|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
65010|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
65011|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
65012|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
65013|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
65014|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
65015|NCT02173769|E2|Reported Event|Spiriva 18 mcg + Striverdi Respimat|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva 18 microgram plus Striverdi Respimat
65016|NCT02173769|E1|Reported Event|Spiriva Respimat + Striverdi Respimat|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat
65017|NCT02173535|B21|Baseline|Total|Total of all reporting groups
65018|NCT02173535|B20|Baseline|VC-LA-AP-JG-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65019|NCT02173535|B19|Baseline|VC-JG-LA-CS-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65020|NCT02173535|B18|Baseline|VC-CS-JG-AP-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65021|NCT02173535|B17|Baseline|VC-AP-CS-LA-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65022|NCT02173535|B16|Baseline|LA-VC-CS-JG-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65023|NCT02173535|B15|Baseline|LA-JG-VC-AP-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65024|NCT02173535|B14|Baseline|LA-CS-AP-VC-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65025|NCT02173535|B13|Baseline|LA-AP-JG-CS-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65026|NCT02173535|B12|Baseline|JG-VC-AP-CS-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65027|NCT02173535|B11|Baseline|JG-LA-CS-AP-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65028|NCT02173535|B10|Baseline|JG-CS-VC-LA-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65029|NCT02173535|B9|Baseline|JG-AP-LA-VC-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65030|NCT02173535|B8|Baseline|CS-LA-JG-VC-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65031|NCT02173535|B7|Baseline|CS-VC-LA-AP-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65032|NCT02173535|B6|Baseline|CS-JG-AP-LA-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65033|NCT02173535|B5|Baseline|CS-AP-VC-JG-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65034|NCT02173535|B4|Baseline|AP-VC-JG-LA-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65035|NCT02173535|B3|Baseline|AP-LA-VC-CS-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65036|NCT02173535|B2|Baseline|AP-JG-CS-VC-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65037|NCT02173535|B1|Baseline|AP-CS-LA-JG-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65038|NCT02173535|P20|Participant Flow|VC-LA-AP-JG-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65039|NCT02173535|P19|Participant Flow|VC-JG-LA-CS-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65040|NCT02173535|P18|Participant Flow|VC-CS-JG-AP-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65041|NCT02173535|P17|Participant Flow|VC-AP-CS-LA-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65042|NCT02173535|P16|Participant Flow|LA-VC-CS-JG-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65752|NCT02169453|E2|Reported Event|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
65043|NCT02173535|P15|Participant Flow|LA-JG-VC-AP-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65044|NCT02173535|P14|Participant Flow|LA-CS-AP-VC-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65045|NCT02173535|P13|Participant Flow|LA-AP-JG-CS-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65046|NCT02173535|P12|Participant Flow|JG-VC-AP-CS-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65047|NCT02173535|P11|Participant Flow|JG-LA-CS-AP-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65048|NCT02173535|P10|Participant Flow|JG-CS-VC-LA-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65049|NCT02173535|P9|Participant Flow|JG-AP-LA-VC-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65050|NCT02173535|P8|Participant Flow|CS-LA-JG-VC-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65051|NCT02173535|P7|Participant Flow|CS-VC-LA-AP-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65052|NCT02173535|P6|Participant Flow|CS-JG-AP-LA-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65053|NCT02173535|P5|Participant Flow|CS-AP-VC-JG-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65054|NCT02173535|P4|Participant Flow|AP-VC-JG-LA-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65055|NCT02173535|P3|Participant Flow|AP-LA-VC-CS-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65056|NCT02173535|P2|Participant Flow|AP-JG-CS-VC-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65057|NCT02173535|P1|Participant Flow|AP-CS-LA-JG-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65058|NCT02173535|O5|Outcome|VC- Etafilcon A|Subjects that wore the VC investigational lens during any of the 5 period of the study.
65059|NCT02173535|O4|Outcome|LA-etafilcon A|Subjects that wore the LA investigational lens during any of the 5 period of the study.
65060|NCT02173535|O3|Outcome|JG-etafilcon A|Subjects that wore the JG investigational lens during any of the 5 period of the study.
65061|NCT02173535|O2|Outcome|CS- Etafilcon A|Subjects that wore the CS investigational lens during any of the 5 period of the study.
65062|NCT02173535|O1|Outcome|AP- Etafilcon A|Subjects that wore the AP investigational lens during any of the 5 period of the study.
65063|NCT02173535|O5|Outcome|VC- Etafilcon A|Subjects that wore the VC investigational lens during any of the 5 period of the study.
65064|NCT02173535|O4|Outcome|LA-etafilcon A|Subjects that wore the LA investigational lens during any of the 5 period of the study.
65065|NCT02173535|O3|Outcome|JG-etafilcon A|Subjects that wore the JG investigational lens during any of the 5 period of the study.
65066|NCT02173535|O2|Outcome|CS- Etafilcon A|Subjects that wore the CS investigational lens during any of the 5 period of the study.
65067|NCT02173535|O1|Outcome|AP- Etafilcon A|Subjects that wore the AP investigational lens during any of the 5 period of the study.
65068|NCT02173535|O5|Outcome|VC- Etafilcon A|Subjects that wore the VC investigational lens during any of the 5 period of the study.
65069|NCT02173535|O4|Outcome|LA-etafilcon A|Subjects that wore the LA investigational lens during any of the 5 period of the study.
65070|NCT02173535|O3|Outcome|JG-etafilcon A|Subjects that wore the JG investigational lens during any of the 5 period of the study.
65071|NCT02173535|O2|Outcome|CS- Etafilcon A|Subjects that wore the CS investigational lens during any of the 5 period of the study.
65072|NCT02173535|O1|Outcome|AP- Etafilcon A|Subjects that wore the AP investigational lens during any of the 5 period of the study.
65073|NCT02173535|E20|Reported Event|VC-LA-AP-JG-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65074|NCT02173535|E19|Reported Event|VC-JG-LA-CS-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65075|NCT02173535|E18|Reported Event|VC-CS-JG-AP-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65076|NCT02173535|E17|Reported Event|VC-AP-CS-LA-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65077|NCT02173535|E16|Reported Event|LA-VC-CS-JG-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65078|NCT02173535|E15|Reported Event|LA-JG-VC-AP-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65079|NCT02173535|E14|Reported Event|LA-CS-AP-VC-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65331|NCT02171234|O1|Outcome|Group 1 - BIA 2-093 200 mg b.i.d.|BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)
65080|NCT02173535|E13|Reported Event|LA-AP-JG-CS-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65081|NCT02173535|E12|Reported Event|JG-VC-AP-CS-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65082|NCT02173535|E11|Reported Event|JG-LA-CS-AP-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65083|NCT02173535|E10|Reported Event|JG-CS-VC-LA-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65084|NCT02173535|E9|Reported Event|JG-AP-LA-VC-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65085|NCT02173535|E8|Reported Event|CS-LA-JG-VC-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65086|NCT02173535|E7|Reported Event|CS-VC-LA-AP-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65087|NCT02173535|E6|Reported Event|CS-JG-AP-LA-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65088|NCT02173535|E5|Reported Event|CS-AP-VC-JG-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65089|NCT02173535|E4|Reported Event|AP-VC-JG-LA-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65090|NCT02173535|E3|Reported Event|AP-LA-VC-CS-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65091|NCT02173535|E2|Reported Event|AP-JG-CS-VC-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65092|NCT02173535|E1|Reported Event|AP-CS-LA-JG-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
65093|NCT02173392|B3|Baseline|Total|Total of all reporting groups
65094|NCT02173392|B2|Baseline|(Treatment B Days 1-28 + Treatment 8 Days 29-56)|"210 mg SC Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL, Treatment B Days 1-28]) first, then Brodalumab (Single 1.5mL Pre-filled Syringe, treatment A Days 29-56)~Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
65095|NCT02173392|B1|Baseline|(Treatment A Day 1-28 + Treatment B Day 29-56)|"210 mg SC Brodalumab (Single 1.5mL, Pre-filled Syringe, treatment A Days 1-28) first, then followed by Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL, treatment A Days 29-56)~Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
65096|NCT02173392|P2|Participant Flow|(Treatment B Days 1-28 + Treatment A Days 29-56)|"210 mg SC Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL, Treatment B Days 1-28]) first, then Brodalumab (Single 1.5mL Pre-filled Syringe, treatment A Days 29-56)~Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
65097|NCT02173392|P1|Participant Flow|(Treatment A Day 1-28 + Treatment B Day 29-56)|"210 mg SC Brodalumab (Single 1.5mL, Pre-filled Syringe, treatment A Days 1-28) first, then followed by Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL, treatment A Days 29-56)~Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
65098|NCT02173392|O2|Outcome|Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL])|"A single 210 mg subcutaneous (SC) dose of Brodalumab administered using 2 (1.0mL + 0.5mL) pre-filled syringe injections~Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
65099|NCT02173392|O1|Outcome|Brodalumab (Single 1.5mL Pre-filled Syringe)|"A single 210 mg subcutaneous (SC) dose of Brodalumab administered using a single 1.5mL pre-filled syringe injection~Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
65100|NCT02173392|O2|Outcome|Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL])|"A single 210 mg subcutaneous (SC) dose of Brodalumab administered using 2 (1.0mL + 0.5mL) pre-filled syringe injections~Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
65101|NCT02173392|O1|Outcome|Brodalumab (Single 1.5mL Pre-filled Syringe)|"A single 210 mg subcutaneous (SC) dose of Brodalumab administered using a single 1.5mL pre-filled syringe injection~Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
65102|NCT02173392|O2|Outcome|Treatment B,Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL])|"A single 210 mg subcutaneous (SC) dose of Brodalumab administered using 2 (1.0mL + 0.5mL) pre-filled syringe injections~Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
65103|NCT02173392|O1|Outcome|Treatment A, Brodalumab (Single 1.5mL Pre-filled Syringe)|"A single 210 mg subcutaneous (SC) dose of Brodalumab administered using a single 1.5mL pre-filled syringe injection~Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
65104|NCT02173392|E2|Reported Event|(Treatment B Days 1-28 + Treatment A Days 29-56)|"210 mg SC Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL, Treatment B Days 1-28]) first, then Brodalumab (Single 1.5mL Pre-filled Syringe, treatment A Days 29-56)~Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
65105|NCT02173392|E1|Reported Event|(Treatment A Day 1-28 + Treatment B Day 29-56)|"210 mg SC Brodalumab (Single 1.5mL, Pre-filled Syringe, treatment A Days 1-28) first, then followed by Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL, treatment A Days 29-56)~Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
65106|NCT02173054|B4|Baseline|Total|Total of all reporting groups
65107|NCT02173054|B3|Baseline|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
65108|NCT02173054|B2|Baseline|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
65109|NCT02173054|B1|Baseline|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
65110|NCT02173054|P3|Participant Flow|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
65111|NCT02173054|P2|Participant Flow|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
65112|NCT02173054|P1|Participant Flow|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
65113|NCT02173054|O3|Outcome|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
65114|NCT02173054|O2|Outcome|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
65115|NCT02173054|O1|Outcome|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
65116|NCT02173054|O3|Outcome|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
65117|NCT02173054|O2|Outcome|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
65118|NCT02173054|O1|Outcome|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
65119|NCT02173054|O3|Outcome|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
65120|NCT02173054|O2|Outcome|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
65121|NCT02173054|O1|Outcome|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
65122|NCT02173054|O3|Outcome|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
65123|NCT02173054|O2|Outcome|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
65124|NCT02173054|O1|Outcome|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
65125|NCT02173054|O3|Outcome|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
65259|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
65126|NCT02173054|O2|Outcome|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
65127|NCT02173054|O1|Outcome|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
65128|NCT02173054|E3|Reported Event|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
65129|NCT02173054|E2|Reported Event|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
65130|NCT02173054|E1|Reported Event|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
65131|NCT02172755|B3|Baseline|Total|Total of all reporting groups
65132|NCT02172755|B2|Baseline|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
65133|NCT02172755|B1|Baseline|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
65134|NCT02172755|P2|Participant Flow|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
65135|NCT02172755|P1|Participant Flow|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
65136|NCT02172755|O2|Outcome|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
65137|NCT02172755|O1|Outcome|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
65138|NCT02172755|O2|Outcome|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
65139|NCT02172755|O1|Outcome|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
65140|NCT02172755|O2|Outcome|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
65141|NCT02172755|O1|Outcome|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
65187|NCT02172040|O1|Outcome|Amlodipine+Celecoxib|"Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks"
65142|NCT02172755|E2|Reported Event|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
65143|NCT02172755|E1|Reported Event|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
65144|NCT02172742|B3|Baseline|Total|Total of all reporting groups
65145|NCT02172742|B2|Baseline|Placebo + BIA 2-093|"Period 1:~Placebo with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin~Period 2:~BIA 2-093 1200 mg with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin"
65146|NCT02172742|B1|Baseline|BIA 2-093 + Placebo|"Period 1:~BIA 2-093 1200 mg with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin~Period 2:~Placebo with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin"
65147|NCT02172742|P2|Participant Flow|Placebo + BIA 2-093|"Period 1:~Placebo with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin~Period 2:~BIA 2-093 1200 mg with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin"
65148|NCT02172742|P1|Participant Flow|BIA 2-093 + Placebo|"Period 1:~BIA 2-093 1200 mg with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin~Period 2:~Placebo with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin"
65149|NCT02172742|O1|Outcome|BIA 2-093 + Placebo|"Both Groups:~Period 1: BIA 2-093; Period 2: Placebo Period 1: Placebo; Period 2: BIA 2-093"
65150|NCT02172742|O1|Outcome|BIA 2-093 + Placebo|"Both Groups:~Period 1: BIA 2-093; Period 2: Placebo Period 1: Placebo; Period 2: BIA 2-093"
65151|NCT02172742|O1|Outcome|BIA 2-093 + Placebo|"Both Groups:~Period 1: BIA 2-093; Period 2: Placebo Period 1: Placebo; Period 2: BIA 2-093"
65152|NCT02172742|E2|Reported Event|Placebo+Digoxin|Placebo + Digoxin
65153|NCT02172742|E1|Reported Event|BIA 2-093+Digoxin|BIA 2-093 + Digoxin
65154|NCT02172625|B3|Baseline|Total|Total of all reporting groups
65155|NCT02172625|B2|Baseline|Protandim Dietary Supplement|"Each subject will ingest 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).~Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation."
65156|NCT02172625|B1|Baseline|Sugar Pill|"Corn starch and food coloring is the placebo comparator. Each subject will ingest 675 mg (1 pill) per day of the placebo comparator~Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation."
65157|NCT02172625|P2|Participant Flow|Protandim Dietary Supplement|"Each subject will ingest 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).~Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation."
65158|NCT02172625|P1|Participant Flow|Sugar Pill|"Corn starch and food coloring is the placebo comparator. Each subject will ingest 675 mg (1 pill) per day of the placebo comparator~Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation."
65159|NCT02172625|O2|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).
65160|NCT02172625|O1|Outcome|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
65161|NCT02172625|O2|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
65162|NCT02172625|O1|Outcome|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
65163|NCT02172625|O2|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
65164|NCT02172625|O1|Outcome|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
65165|NCT02172625|O2|Outcome|Protandim Group|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
65186|NCT02172040|O2|Outcome|Amlodipine+Placebo|"Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks"
65166|NCT02172625|O1|Outcome|Placebo Group|"Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator~Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation."
65167|NCT02172625|O2|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).
65168|NCT02172625|O1|Outcome|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
65169|NCT02172625|O2|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contained 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
65170|NCT02172625|O1|Outcome|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
65171|NCT02172625|O2|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
65172|NCT02172625|O1|Outcome|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
65173|NCT02172625|E2|Reported Event|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).
65174|NCT02172625|E1|Reported Event|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
65175|NCT02172040|B5|Baseline|Total|Total of all reporting groups
65176|NCT02172040|B4|Baseline|Placebo+Placebo|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
65177|NCT02172040|B3|Baseline|Placebo+Celecoxib|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
65178|NCT02172040|B2|Baseline|Amlodipine+Placebo|"Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks"
65179|NCT02172040|B1|Baseline|Amlodipine+Celecoxib|"Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks"
65180|NCT02172040|P4|Participant Flow|Placebo+Placebo|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
65181|NCT02172040|P3|Participant Flow|Placebo+Celecoxib|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
65182|NCT02172040|P2|Participant Flow|Amlodipine+Placebo|"Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks"
65183|NCT02172040|P1|Participant Flow|Amlodipine+Celecoxib|"Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks"
65184|NCT02172040|O4|Outcome|Placebo+Placebo|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
65185|NCT02172040|O3|Outcome|Placebo+Celecoxib|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
65317|NCT02171234|B5|Baseline|Group 4 - BIA 2-093 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 1200mg
65318|NCT02171234|B4|Baseline|Group 3 - BIA 2-093 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 800mg
65188|NCT02172040|O2|Outcome|Placebo+Celecoxib|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
65189|NCT02172040|O1|Outcome|Amlodipine+Celecoxib|"Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks"
65190|NCT02172040|O2|Outcome|Amlodipine+Placebo|"Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks"
65191|NCT02172040|O1|Outcome|Amlodipine+Celecoxib|"Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks"
65192|NCT02172040|O2|Outcome|Placebo+Celecoxib|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
65193|NCT02172040|O1|Outcome|Amlodipine+Celecoxib|"Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks"
65194|NCT02172040|O2|Outcome|Amlodipine+Placebo|"Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks"
65195|NCT02172040|O1|Outcome|Amlodipine+Celecoxib|"Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks"
65196|NCT02172040|O4|Outcome|Placebo+Placebo|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
65197|NCT02172040|O3|Outcome|Placebo+Celecoxib|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
65198|NCT02172040|O2|Outcome|Amlodipine+Placebo|"Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks"
65199|NCT02172040|O1|Outcome|Amlodipine+Celecoxib|"Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks"
65200|NCT02172040|O4|Outcome|Placebo+Placebo|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
65201|NCT02172040|O3|Outcome|Placebo+Celecoxib|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
65202|NCT02172040|O2|Outcome|Amlodipine+Placebo|"Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks"
65203|NCT02172040|O1|Outcome|Amlodipine+Celecoxib|"Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks"
65319|NCT02171234|B3|Baseline|Group 2 - BIA 2-093 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 400mg
65320|NCT02171234|B2|Baseline|Group 1 - BIA 2-093 200 mg b.i.d.|BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)
65204|NCT02172040|O4|Outcome|Placebo+Placebo|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
65205|NCT02172040|O3|Outcome|Placebo+Celecoxib|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
65206|NCT02172040|O2|Outcome|Amlodipine+Placebo|"Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks"
65207|NCT02172040|O1|Outcome|Amlodipine+Celecoxib|"Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks"
65208|NCT02172040|O4|Outcome|Placebo+Placebo|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
65209|NCT02172040|O3|Outcome|Placebo+Celecoxib|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
65210|NCT02172040|O2|Outcome|Amlodipine+Placebo|"Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks"
65211|NCT02172040|O1|Outcome|Amlodipine+Celecoxib|"Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks"
65212|NCT02172040|O4|Outcome|Placebo+Placebo|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
65213|NCT02172040|O3|Outcome|Placebo+Celecoxib|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
65214|NCT02172040|O2|Outcome|Amlodipine+Placebo|"Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks"
65215|NCT02172040|O1|Outcome|Amlodipine+Celecoxib|"Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks"
65216|NCT02172040|O4|Outcome|Placebo+Placebo|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
65217|NCT02172040|O3|Outcome|Placebo+Celecoxib|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
65218|NCT02172040|O2|Outcome|Amlodipine+Placebo|"Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks"
65219|NCT02172040|O1|Outcome|Amlodipine+Celecoxib|"Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks"
65220|NCT02172040|O4|Outcome|Placebo+Placebo|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
65221|NCT02172040|O3|Outcome|Placebo+Celecoxib|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
65222|NCT02172040|O2|Outcome|Amlodipine+Placebo|"Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks"
65223|NCT02172040|O1|Outcome|Amlodipine+Celecoxib|"Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks"
65224|NCT02172040|E4|Reported Event|Placebo+Placebo|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
65225|NCT02172040|E3|Reported Event|Placebo+Celecoxib|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
65226|NCT02172040|E2|Reported Event|Amlodipine+Placebo|"Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks"
65227|NCT02172040|E1|Reported Event|Amlodipine+Celecoxib|"Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks"
65228|NCT02171611|B1|Baseline|Overall|This study is open-label, single dose, randomised, three-way crossover design having 3 treatment periods ie., Dabigatran etexilate 150 mg formulation capsule: Reference (A), Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) and Dabigatran etexilate 150 mg formulation powder: Test 2 (C)
65229|NCT02171611|P6|Participant Flow|C/B/A|"Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution and in period 2 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject, followed in Period 3 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water.~Treatments were separated by washout period of at least 7 days after drug administration."
65230|NCT02171611|P5|Participant Flow|C/A/B|Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution and in period 2 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water, followed in Period 3 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject. Treatments were separated by washout period of at least 7 days after drug administration.
65231|NCT02171611|P4|Participant Flow|B/C/A|"Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject and in period 2 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution, followed in period 3 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water.~Treatments were separated by washout period of at least 7 days after drug administration."
65232|NCT02171611|P3|Participant Flow|B/A/C|"Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject and in period 2 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water, followed in Period 3 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution.~Treatments were separated by washout period of at least 7 days after drug administration."
65233|NCT02171611|P2|Participant Flow|A/C/B|"Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water and in period 2 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution, followed in Period 3 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject.~Treatments were separated by washout period of at least 7 days after drug administration."
65258|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
65321|NCT02171234|B1|Baseline|Placebo|PLC, Placebo
65322|NCT02171234|P5|Participant Flow|Group 4 - 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine 1200mg
65234|NCT02171611|P1|Participant Flow|A/B/C|"Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water and in Period 2 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject, followed in period 3 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution.~Treatments were separated by washout period of at least 7 days after drug administration."
65235|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
65236|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
65237|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
65238|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
65239|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
65240|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
65241|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
65242|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
65243|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
65244|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
65245|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
65246|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
65247|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
65248|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
65249|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
65250|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
65251|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
65252|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
65253|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
65254|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
65255|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
65256|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
65257|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
65260|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
65261|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
65262|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
65263|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
65264|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
65265|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
65266|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
65267|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
65268|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
65269|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
65270|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
65271|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
65272|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
65273|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
65274|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
65275|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
65276|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
65277|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
65278|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
65279|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
65280|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
65281|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
65282|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
65283|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
65284|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
65285|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
65286|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
65287|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
65288|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
65289|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
65290|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
65291|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
65292|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
65293|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
65294|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
65295|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
65296|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
65297|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
65298|NCT02171611|E3|Reported Event|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
65299|NCT02171611|E2|Reported Event|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
65300|NCT02171611|E1|Reported Event|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
65301|NCT02171247|B3|Baseline|Total|Total of all reporting groups
65302|NCT02171247|B2|Baseline|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.~Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
65303|NCT02171247|B1|Baseline|Visipaque 320|"Standard protocol is Visipaque 320.~Visipaque 320: Visipaque 320 is standard protocol."
65304|NCT02171247|P2|Participant Flow|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.~Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
65305|NCT02171247|P1|Participant Flow|Visipaque 320|"Standard protocol is Visipaque 320.~Visipaque 320: Visipaque 320 is standard protocol."
65306|NCT02171247|O2|Outcome|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.~Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
65307|NCT02171247|O1|Outcome|Visipaque 320|"Standard protocol is Visipaque 320.~Visipaque 320: Visipaque 320 is standard protocol."
65308|NCT02171247|O2|Outcome|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.~Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
65309|NCT02171247|O1|Outcome|Visipaque 320|"Standard protocol is Visipaque 320.~Visipaque 320: Visipaque 320 is standard protocol."
65310|NCT02171247|O2|Outcome|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.~Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
65311|NCT02171247|O1|Outcome|Visipaque 320|"Standard protocol is Visipaque 320.~Visipaque 320: Visipaque 320 is standard protocol."
65312|NCT02171247|O2|Outcome|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.~Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
65313|NCT02171247|O1|Outcome|Visipaque 320|"Standard protocol is Visipaque 320.~Visipaque 320: Visipaque 320 is standard protocol."
65314|NCT02171247|E2|Reported Event|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.~Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
65315|NCT02171247|E1|Reported Event|Visipaque 320|"Standard protocol is Visipaque 320.~Visipaque 320: Visipaque 320 is standard protocol."
65316|NCT02171234|B6|Baseline|Total|Total of all reporting groups
65332|NCT02171234|O4|Outcome|Group 4 - BIA 2-093 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 1200mg
65333|NCT02171234|O3|Outcome|Group 3 - BIA 2-093 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 800mg
65334|NCT02171234|O2|Outcome|Group 2 - BIA 2-093 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 400mg
65335|NCT02171234|O1|Outcome|Group 1 - BIA 2-093 200 mg b.i.d.|BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)
65336|NCT02171234|O4|Outcome|Group 4 - BIA 2-093 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 1200mg
65337|NCT02171234|O3|Outcome|Group 3 - BIA 2-093 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 800mg
65338|NCT02171234|O2|Outcome|Group 2 - BIA 2-093 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 400mg
65339|NCT02171234|O1|Outcome|Group 1 - BIA 2-093 200 mg b.i.d.|BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)
65340|NCT02171234|E5|Reported Event|Group 4 - BIA 2-093 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 1200mg
65341|NCT02171234|E4|Reported Event|Group 3 - BIA 2-093 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 800mg
65342|NCT02171234|E3|Reported Event|Group 2 - BIA 2-093 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 400mg
65343|NCT02171234|E2|Reported Event|Group 1 - BIA 2-093 200 mg b.i.d.|BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)
65344|NCT02171234|E1|Reported Event|Placebo|PLC, Placebo
65345|NCT02171195|B10|Baseline|Total|Total of all reporting groups
65346|NCT02171195|B9|Baseline|Group 8 1200 mg|BIA 2-093 1200mg or placebo
65347|NCT02171195|B8|Baseline|Group 7 900 mg|BIA 2-093 900mg or placebo
65348|NCT02171195|B7|Baseline|Group 6 600 mg|BIA 2-093 600mg or placebo
65349|NCT02171195|B6|Baseline|Group 5 400 mg|BIA 2-093 or 400mg or placebo
65350|NCT02171195|B5|Baseline|Group 4 200 mg|BIA 2-093 200mg or placebo
65351|NCT02171195|B4|Baseline|Group 3 100 mg|BIA 2-093 100mg or placebo
65352|NCT02171195|B3|Baseline|Group 2 50 mg|BIA 2-093 50mg or placebo
65353|NCT02171195|B2|Baseline|Group 1 20 mg|BIA 2-093 20mg or placebo.
65354|NCT02171195|B1|Baseline|Placebo|Placebo, PLC
65355|NCT02171195|P9|Participant Flow|Group 8 1200 mg|BIA 2-093 1200mg or placebo
65356|NCT02171195|P8|Participant Flow|Group 7 900 mg|BIA 2-093 900mg or placebo
65357|NCT02171195|P7|Participant Flow|Group 6 600 mg|BIA 2-093 600mg or placebo
65358|NCT02171195|P6|Participant Flow|Group 5 400 mg|BIA 2-093 or 400mg or placebo
65359|NCT02171195|P5|Participant Flow|Group 4 200 mg|BIA 2-093 200mg or placebo
65360|NCT02171195|P4|Participant Flow|Group 3 100 mg|BIA 2-093 100mg or placebo
65361|NCT02171195|P3|Participant Flow|Group 2 50 mg|BIA 2-093 50mg or placebo
65362|NCT02171195|P2|Participant Flow|Group 1 20 mg|BIA 2-093 20mg or placebo.
65363|NCT02171195|P1|Participant Flow|Placebo|Placebo, PLC
65364|NCT02171195|O9|Outcome|Group 8 1200 mg|BIA 2-093 1200mg or placebo
65365|NCT02171195|O8|Outcome|Group 7 900 mg|BIA 2-093 900mg or placebo
65366|NCT02171195|O7|Outcome|Group 6 600 mg|BIA 2-093 600mg or placebo
65367|NCT02171195|O6|Outcome|Group 5 400 mg|BIA 2-093 or 400mg or placebo
65368|NCT02171195|O5|Outcome|Group 4 200 mg|BIA 2-093 200mg or placebo
65369|NCT02171195|O4|Outcome|Group 3 100 mg|BIA 2-093 100mg or placebo
65370|NCT02171195|O3|Outcome|Group 2 50 mg|BIA 2-093 50mg or placebo
65371|NCT02171195|O2|Outcome|Group 1 20 mg|BIA 2-093 20mg or placebo.
65372|NCT02171195|O1|Outcome|Placebo|Placebo, PLC
65373|NCT02171195|E9|Reported Event|Group 8 1200 mg|BIA 2-093 1200mg or placebo
65374|NCT02171195|E8|Reported Event|Group 7 900 mg|BIA 2-093 900mg or placebo
65375|NCT02171195|E7|Reported Event|Group 6 600 mg|BIA 2-093 600mg or placebo
65376|NCT02171195|E6|Reported Event|Group 5 400 mg|BIA 2-093 or 400mg or placebo
65377|NCT02171195|E5|Reported Event|Group 4 200 mg|BIA 2-093 200mg or placebo
65378|NCT02171195|E4|Reported Event|Group 3 100 mg|BIA 2-093 100mg or placebo
65379|NCT02171195|E3|Reported Event|Group 2 50 mg|BIA 2-093 50mg or placebo
65380|NCT02171195|E2|Reported Event|Group 1 20 mg|BIA 2-093 20mg or placebo.
65381|NCT02171195|E1|Reported Event|Placebo|Placebo, PLC
65382|NCT02170779|B3|Baseline|Total|Total of all reporting groups
65383|NCT02170779|B2|Baseline|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
65384|NCT02170779|B1|Baseline|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
65385|NCT02170779|P2|Participant Flow|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
65386|NCT02170779|P1|Participant Flow|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
65387|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
65388|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
65389|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
65390|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
65391|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
65392|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
65393|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
65394|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
65395|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
65396|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
65397|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
65398|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
65399|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
65400|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
65401|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
65402|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
65403|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
65404|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
65405|NCT02170779|E2|Reported Event|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
65406|NCT02170779|E1|Reported Event|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
65407|NCT02170688|B6|Baseline|Total|Total of all reporting groups
65408|NCT02170688|B5|Baseline|Estimated Lean Body (eLBW) Weight|"25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
65409|NCT02170688|B4|Baseline|Measured Lean Body Weight|"50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
65410|NCT02170688|B3|Baseline|Calculated Lean Body Weight|"25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
65411|NCT02170688|B2|Baseline|Total Body Weight|"25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
65412|NCT02170688|B1|Baseline|Fixed Dose|"50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert."
65440|NCT02170662|O2|Outcome|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were randomized to apply placebo topically for 16 weeks."
65472|NCT02170532|O5|Outcome|Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs|"levalbuterol MDI + aerochamber max with 2 second pause 2 puffs~levalbuterol MDI~aerochamber max"
65413|NCT02170688|P5|Participant Flow|Estimated Lean Body (eLBW) Weight|"25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
65414|NCT02170688|P4|Participant Flow|Measured Lean Body Weight|"50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
65415|NCT02170688|P3|Participant Flow|Calculated Lean Body Weight|"25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
65416|NCT02170688|P2|Participant Flow|Total Body Weight|"25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
65417|NCT02170688|P1|Participant Flow|Fixed Dose|"50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert."
65418|NCT02170688|O5|Outcome|Estimated Lean Body (eLBW) Weight|"25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
65419|NCT02170688|O4|Outcome|Measured Lean Body Weight|"50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
65420|NCT02170688|O3|Outcome|Calculated Lean Body Weight|"25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
65421|NCT02170688|O2|Outcome|Total Body Weight|"25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
65422|NCT02170688|O1|Outcome|Fixed Dose|"50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert."
65423|NCT02170688|O5|Outcome|Estimated Lean Body (eLBW) Weight|"25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
65441|NCT02170662|O1|Outcome|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
65424|NCT02170688|O4|Outcome|Measured Lean Body Weight|"50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
65425|NCT02170688|O3|Outcome|Calculated Lean Body Weight|"25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
65426|NCT02170688|O2|Outcome|Total Body Weight|"25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
65427|NCT02170688|O1|Outcome|Fixed Dose|"50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert."
65428|NCT02170688|E5|Reported Event|Estimated Lean Body (eLBW) Weight|"25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
65429|NCT02170688|E4|Reported Event|Measured Lean Body Weight|"50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
65430|NCT02170688|E3|Reported Event|Calculated Lean Body Weight|"25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
65431|NCT02170688|E2|Reported Event|Total Body Weight|"25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
65432|NCT02170688|E1|Reported Event|Fixed Dose|"50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert."
65433|NCT02170662|B3|Baseline|Total|Total of all reporting groups
65434|NCT02170662|B2|Baseline|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were randomized to apply placebo topically for 16 weeks."
65435|NCT02170662|B1|Baseline|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
65436|NCT02170662|P2|Participant Flow|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were randomized to apply placebo topically for 16 weeks."
65437|NCT02170662|P1|Participant Flow|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
65438|NCT02170662|O2|Outcome|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were randomized to apply placebo topically for 16 weeks."
65439|NCT02170662|O1|Outcome|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
65442|NCT02170662|O2|Outcome|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were randomized to apply placebo topically for 16 weeks."
65443|NCT02170662|O1|Outcome|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
65444|NCT02170662|O2|Outcome|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were randomized to apply placebo topically for 16 weeks."
65445|NCT02170662|O1|Outcome|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
65446|NCT02170662|E2|Reported Event|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were randomized to apply placebo topically for 16 weeks."
65447|NCT02170662|E1|Reported Event|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
65448|NCT02170649|B1|Baseline|Fasting Period|single 800 mg oral dose of BIA 2-093 following 10 hours of fasting or following either a standard high fat content breakfast.
65449|NCT02170649|P1|Participant Flow|BIA 2-093 (Fasting & Fed)|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
65450|NCT02170649|O1|Outcome|Single Group|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
65451|NCT02170649|O1|Outcome|Single Group|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
65452|NCT02170649|O1|Outcome|Single Group|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
65453|NCT02170649|O1|Outcome|Single Group|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
65454|NCT02170649|E1|Reported Event|Single Group|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
65455|NCT02170532|B1|Baseline|All Subjects|All subjects will receive all 5 treatments on 5 different treatment days. Each subject will receive all 5 treatments in the same order.
65456|NCT02170532|P1|Participant Flow|All Subjects|All subjects will receive all 5 treatments on 5 different treatment days. Each subject will receive all 5 treatments in the same order.
65457|NCT02170532|O5|Outcome|Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs|"levalbuterol MDI + aerochamber max with 2 second pause 2 puffs~levalbuterol MDI~aerochamber max"
65458|NCT02170532|O4|Outcome|Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs|"levalbuterol MDI + aerochamber max without pause 2 puffs~levalbuterol MDI~aerochamber max"
65459|NCT02170532|O3|Outcome|Levalbuterol MDI 2 Puffs|"levalbuterol metered dose inhaler 2 puffs~levalbuterol MDI"
65460|NCT02170532|O2|Outcome|Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~breath actuated nebulizer~ipratroprium"
65461|NCT02170532|O1|Outcome|Levalbuterol + Saline in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~saline: 0.5ml saline~breath actuated nebulizer"
65462|NCT02170532|O5|Outcome|Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs|"levalbuterol MDI + aerochamber max with 2 second pause 2 puffs~levalbuterol MDI~aerochamber max"
65463|NCT02170532|O4|Outcome|Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs|"levalbuterol MDI + aerochamber max without pause 2 puffs~levalbuterol MDI~aerochamber max"
65464|NCT02170532|O3|Outcome|Levalbuterol MDI 2 Puffs|"levalbuterol metered dose inhaler 2 puffs~levalbuterol MDI"
65465|NCT02170532|O2|Outcome|Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~breath actuated nebulizer~ipratroprium"
65466|NCT02170532|O1|Outcome|Levalbuterol + Saline in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~saline: 0.5ml saline~breath actuated nebulizer"
65467|NCT02170532|O5|Outcome|Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs|"levalbuterol MDI + aerochamber max with 2 second pause 2 puffs~levalbuterol MDI~aerochamber max"
65468|NCT02170532|O4|Outcome|Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs|"levalbuterol MDI + aerochamber max without pause 2 puffs~levalbuterol MDI~aerochamber max"
65469|NCT02170532|O3|Outcome|Levalbuterol MDI 2 Puffs|"levalbuterol metered dose inhaler 2 puffs~levalbuterol MDI"
65470|NCT02170532|O2|Outcome|Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~breath actuated nebulizer~ipratroprium"
65471|NCT02170532|O1|Outcome|Levalbuterol + Saline in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~saline: 0.5ml saline~breath actuated nebulizer"
65753|NCT02169453|E1|Reported Event|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
65473|NCT02170532|O4|Outcome|Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs|"levalbuterol MDI + aerochamber max without pause 2 puffs~levalbuterol MDI~aerochamber max"
65474|NCT02170532|O3|Outcome|Levalbuterol MDI 2 Puffs|"levalbuterol metered dose inhaler 2 puffs~levalbuterol MDI"
65475|NCT02170532|O2|Outcome|Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~breath actuated nebulizer~ipratroprium"
65476|NCT02170532|O1|Outcome|Levalbuterol + Saline in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~saline: 0.5ml saline~breath actuated nebulizer"
65477|NCT02170532|O5|Outcome|Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs|"levalbuterol metered dose inhaler (MDI) + aerochamber max with 2 second pause 2 puffs~levalbuterol MDI~aerochamber max"
65478|NCT02170532|O4|Outcome|Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs|"levalbuterol metered-dose inhaler (MDI) + aerochamber max without pause 2 puffs~levalbuterol MDI~aerochamber max"
65479|NCT02170532|O3|Outcome|Levalbuterol Metered Dose Inhaler (MDI) 2 Puffs|"levalbuterol metered dose inhaler (MDI) 2 puffs~levalbuterol MDI"
65480|NCT02170532|O2|Outcome|Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~breath actuated nebulizer~ipratroprium"
65481|NCT02170532|O1|Outcome|Levalbuterol + Saline in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~saline: 0.5ml saline~breath actuated nebulizer"
65482|NCT02170532|E1|Reported Event|All Subjects|All subjects will receive all 5 treatments on 5 different treatment days. Each subject will receive all 5 treatments in the same order.
65483|NCT02170519|B3|Baseline|Total|Total of all reporting groups
65484|NCT02170519|B2|Baseline|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
65485|NCT02170519|B1|Baseline|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
65486|NCT02170519|P2|Participant Flow|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
65487|NCT02170519|P1|Participant Flow|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
65488|NCT02170519|O1|Outcome|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose and data collected 5 minutes later (combined therapy). Another 1 hour period of stable baseline dose INO therapy will be given during which the final data collection will occur (end INO).~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
65489|NCT02170519|O1|Outcome|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
65490|NCT02170519|O1|Outcome|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose and data collected 5 minutes later (combined therapy). Another 1 hour period of stable baseline dose INO therapy will be given during which the final data collection will occur (end INO).~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
65491|NCT02170519|O1|Outcome|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
65507|NCT02170376|B1|Baseline|Group 1|"Placebo once-daily for 11 days 200 mg entacapone concomitantly with levodopa/carbidopa on Day 12~Entacapone: Entacapone (ENT), over-encapsulated tablet 200 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
65754|NCT02169440|B3|Baseline|Total|Total of all reporting groups
65492|NCT02170519|O2|Outcome|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
65493|NCT02170519|O1|Outcome|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
65494|NCT02170519|O1|Outcome|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose and data collected 5 minutes later (combined therapy). Another 1 hour period of stable baseline dose INO therapy will be given during which the final data collection will occur (end INO).~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
65495|NCT02170519|O1|Outcome|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
65496|NCT02170519|O1|Outcome|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose and data collected 5 minutes later (combined therapy). Another 1 hour period of stable baseline dose INO therapy will be given during which the final data collection will occur (end INO).~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
65497|NCT02170519|O1|Outcome|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
65498|NCT02170519|O1|Outcome|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose and data collected 5 minutes later (combined therapy). Another 1 hour period of stable baseline dose INO therapy will be given during which the final data collection will occur (end INO).~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
65499|NCT02170519|O1|Outcome|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
65500|NCT02170519|E2|Reported Event|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
65501|NCT02170519|E1|Reported Event|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
65502|NCT02170376|B6|Baseline|Total|Total of all reporting groups
65503|NCT02170376|B5|Baseline|Group 5|"placebo once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
65504|NCT02170376|B4|Baseline|Group 4|"75 mg 9-1067 once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
65505|NCT02170376|B3|Baseline|Group 3|"50 mg 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
65506|NCT02170376|B2|Baseline|Group 2|"25 mg BIA 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
65557|NCT02170363|O1|Outcome|HeartMate 3|Left Ventricular Assist System (LVAS) to be used on Subjects with advanced refractory left ventricular heart failure
65508|NCT02170376|P5|Participant Flow|Group 5: Placebo Then Levodopa/Carbidopa|"placebo once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
65509|NCT02170376|P4|Participant Flow|Group 4: BIA 75 mg Then Placebo/Levodopa/Carbidopa|"75 mg 9-1067 once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
65510|NCT02170376|P3|Participant Flow|Group 3: BIA 50 mg Then Placebo/Levodopa/Carbidopa|"50 mg 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
65511|NCT02170376|P2|Participant Flow|Group 2: BIA 25 mg Then Placebo/Levodopa/Carbidopa|"25 mg BIA 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
65512|NCT02170376|P1|Participant Flow|Group 1: Placebo Then Entacapone/Levodopa|"Placebo once-daily for 11 days 200 mg entacapone concomitantly with levodopa/carbidopa on Day 12~Entacapone: Entacapone (ENT), over-encapsulated tablet 200 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
65513|NCT02170376|O5|Outcome|ENT 200 mg|Entacapone (ENT), over-encapsulated tablet 200 mg
65514|NCT02170376|O4|Outcome|OPC 75 mg|OPC: BIA 9-1067 25 mg and 50 mg
65515|NCT02170376|O3|Outcome|OPC 50 mg|OPC: BIA 9-1067 50 mg
65516|NCT02170376|O2|Outcome|OPC 25 mg|OPC: BIA 9-1067 25 mg
65517|NCT02170376|O1|Outcome|Placebo|Placebo: PLC, placebo
65518|NCT02170376|O5|Outcome|ENT 200 mg|Entacapone (ENT), over-encapsulated tablet 200 mg
65519|NCT02170376|O4|Outcome|OPC 75 mg|OPC: BIA 9-1067 25 mg and 50 mg
65520|NCT02170376|O3|Outcome|OPC 50 mg|OPC: BIA 9-1067 50 mg
65521|NCT02170376|O2|Outcome|OPC 25 mg|OPC: BIA 9-1067 25 mg
65522|NCT02170376|O1|Outcome|Placebo|Placebo: PLC, placebo
65523|NCT02170376|O5|Outcome|ENT 200 mg|Entacapone (ENT), over-encapsulated tablet 200 mg
65524|NCT02170376|O4|Outcome|OPC 75 mg|OPC: BIA 9-1067 25 mg and 50 mg
65525|NCT02170376|O3|Outcome|OPC 50 mg|OPC: BIA 9-1067 50 mg
65526|NCT02170376|O2|Outcome|OPC 25 mg|OPC: BIA 9-1067 25 mg
65527|NCT02170376|O1|Outcome|Placebo|Placebo: PLC, placebo
65528|NCT02170376|O5|Outcome|ENT 200 mg|Entacapone (ENT), over-encapsulated tablet 200 mg
65529|NCT02170376|O4|Outcome|OPC 75 mg|OPC: BIA 9-1067 25 mg and 50 mg
65530|NCT02170376|O3|Outcome|OPC 50 mg|OPC: BIA 9-1067 50 mg
65531|NCT02170376|O2|Outcome|OPC 25 mg|OPC: BIA 9-1067 25 mg
65532|NCT02170376|O1|Outcome|Placebo|Placebo: PLC, placebo
65533|NCT02170376|O5|Outcome|ENT 200 mg|Entacapone (ENT), over-encapsulated tablet 200 mg
65534|NCT02170376|O4|Outcome|OPC 75 mg|OPC: BIA 9-1067 25 mg and 50 mg
65535|NCT02170376|O3|Outcome|OPC 50 mg|OPC: BIA 9-1067 50 mg
65536|NCT02170376|O2|Outcome|OPC 25 mg|OPC: BIA 9-1067 25 mg
65537|NCT02170376|O1|Outcome|Placebo|Placebo: PLC, placebo
65538|NCT02170376|O5|Outcome|ENT 200 mg|Entacapone (ENT), over-encapsulated tablet 200 mg
65539|NCT02170376|O4|Outcome|OPC 75 mg|OPC: BIA 9-1067 25 mg and 50 mg
65540|NCT02170376|O3|Outcome|OPC 50 mg|OPC: BIA 9-1067 50 mg
65541|NCT02170376|O2|Outcome|OPC 25 mg|OPC: BIA 9-1067 25 mg
65542|NCT02170376|O1|Outcome|Placebo|Placebo: PLC, placebo
65543|NCT02170376|E5|Reported Event|Group 5|"placebo once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
65544|NCT02170376|E4|Reported Event|Group 4|"75 mg 9-1067 once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
65545|NCT02170376|E3|Reported Event|Group 3|"50 mg 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
65546|NCT02170376|E2|Reported Event|Group 2|"25 mg BIA 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
65547|NCT02170376|E1|Reported Event|Group 1|"Placebo once-daily for 11 days 200 mg entacapone concomitantly with levodopa/carbidopa on Day 12~Entacapone: Entacapone (ENT), over-encapsulated tablet 200 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
65548|NCT02170363|B1|Baseline|HeartMate 3|HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
65549|NCT02170363|P1|Participant Flow|HeartMate 3|HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
65550|NCT02170363|O1|Outcome|HeartMate 3|HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
65551|NCT02170363|O1|Outcome|HeartMate 3|HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
65552|NCT02170363|O1|Outcome|HeartMate 3|HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
65553|NCT02170363|O1|Outcome|HeartMate 3|HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
65554|NCT02170363|O1|Outcome|HeartMate 3|HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
65555|NCT02170363|O1|Outcome|HeartMate 3|"Left Ventricular Assist System (LVAS) to be used on Subjects with advanced refractory left ventricular heart failure~Left Ventricular Assist System (LVAS): Implantation of left ventricular assist device for hemodynamic support"
65556|NCT02170363|O1|Outcome|HeartMate 3|Left Ventricular Assist System (LVAS) to be used on Subjects with advanced refractory left ventricular heart failure
65558|NCT02170363|O1|Outcome|HeartMate 3|HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
65559|NCT02170363|E1|Reported Event|HeartMate 3|Left Ventricular Assist System (LVAS) to be used on Subjects with advanced refractory left ventricular heart failure
65560|NCT02170220|B3|Baseline|Total|Total of all reporting groups
65561|NCT02170220|B2|Baseline|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
65562|NCT02170220|B1|Baseline|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
65563|NCT02170220|P2|Participant Flow|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
65564|NCT02170220|P1|Participant Flow|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
65565|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
65566|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
65567|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
65568|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
65569|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
65570|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
65571|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
65572|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
65573|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
65574|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
65575|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
65576|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
65577|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
65578|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
65579|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
65580|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
65581|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
65582|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
65583|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
65584|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
65585|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
65586|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
65587|NCT02170220|E2|Reported Event|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
65588|NCT02170220|E1|Reported Event|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
65589|NCT02170207|B1|Baseline|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
65590|NCT02170207|P1|Participant Flow|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
65591|NCT02170207|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
65592|NCT02170207|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
65593|NCT02170207|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
65594|NCT02170207|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
65595|NCT02170207|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
65596|NCT02170207|E1|Reported Event|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
65597|NCT02170077|B4|Baseline|Total|Total of all reporting groups
65598|NCT02170077|B3|Baseline|PLG – Placebo Group|"placebo~Placebo: Placebo tablets administered orally"
65599|NCT02170077|B2|Baseline|TDG - Twice-daily Group|"BIA 2-093 twice-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).~BIA 2-093: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route"
65600|NCT02170077|B1|Baseline|ODG - Once-daily Group|"BIA 2-093 once-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).~BIA 2-093: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route"
65601|NCT02170077|P3|Participant Flow|PLG – Placebo Group|"placebo~Placebo: Placebo tablets administered orally"
65602|NCT02170077|P2|Participant Flow|TDG - Twice-daily Group|"BIA 2-093 twice-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).~BIA 2-093: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route"
65603|NCT02170077|P1|Participant Flow|ODG - Once-daily Group|"BIA 2-093 once-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).~BIA 2-093: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route"
65604|NCT02170077|O3|Outcome|PLG - Placebo Group|Intent to treat (TT) Population
65605|NCT02170077|O2|Outcome|TDG - Twice Daily Group|Intent to treat (TT) Population
65606|NCT02170077|O1|Outcome|ODG - Once Daily Group|Intent to treat (TT) Population
65607|NCT02170077|E3|Reported Event|PLG - Placebo Group|Intent to treat (TT) Population
65608|NCT02170077|E2|Reported Event|TDG - Twice Daily Group|Intent to treat (TT) Population
65609|NCT02170077|E1|Reported Event|ODG - Once Daily Group|Intent to treat (TT) Population
65610|NCT02170064|B4|Baseline|Total|Total of all reporting groups
65611|NCT02170064|B3|Baseline|Group 3 (12-17 Yrs)|Efficacy population (EP)
65612|NCT02170064|B2|Baseline|Group 2 (7-11 Yrs)|Efficacy population (EP)
65613|NCT02170064|B1|Baseline|Group 1 (2-6 Yrs)|Efficacy population (EP)
65614|NCT02170064|P3|Participant Flow|Group 3 (12-17 Years)|"At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5–8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9–12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate (“compassionate use”) if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient’s interest.~For Group 2 (7–11 years) and Group 3 (12–17 years), Eslicarbazepine acetate strengths 200 mg, 400 mg, 600 mg and 800 mg tablets might be used. The dose was to be rounded to the nearest 100 mg unit. Half tablets might be used for dosage adjustment (tablets were scored)."
65615|NCT02170064|P2|Participant Flow|Group 2 (7-11 Years)|"At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5–8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9–12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate (“compassionate use”) if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient’s interest.~For Group 2 (7–11 years) and Group 3 (12–17 years), Eslicarbazepine acetate strengths 200 mg, 400 mg, 600 mg and 800 mg tablets might be used. The dose was to be rounded to the nearest 100 mg unit. Half tablets might be used for dosage adjustment (tablets were scored)."
65616|NCT02170064|P1|Participant Flow|Group 1 (2-6 Yrs)|"At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5–8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9–12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate (“compassionate use”) if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient’s interest.~For Group 1 (2–6 years), oral suspension 50 mg/mL was used. The dose was to be rounded to the nearest 25 mg unit."
65617|NCT02170064|O3|Outcome|Group 3 (12-17 Yrs)|Efficacy population (EP)
65618|NCT02170064|O2|Outcome|Group 2 (7-11 Yrs)|Efficacy population (EP)
65619|NCT02170064|O1|Outcome|Group 1 (2-6 Yrs)|Efficacy population (EP)
65620|NCT02170064|O3|Outcome|Group 3 (12-17 Yrs)|Efficacy population (EP)
65621|NCT02170064|O2|Outcome|Group 2 (7-11 Yrs)|Efficacy population (EP)
65622|NCT02170064|O1|Outcome|Group 1 (2-6 Yrs)|Efficacy population (EP)
65623|NCT02170064|O3|Outcome|Group 3 (12-17 Yrs)|Efficacy population (EP)
65624|NCT02170064|O2|Outcome|Group 2 (7-11 Yrs)|Efficacy population (EP)
65625|NCT02170064|O1|Outcome|Group 1 (2-6 Yrs)|Efficacy population (EP)
65626|NCT02170064|E3|Reported Event|Group 3 (12-17 Yrs)|Safety population (SP)
65627|NCT02170064|E2|Reported Event|Group 2 (7-11 Yrs)|Safety population (SP)
65628|NCT02170064|E1|Reported Event|Group 1 (2-6 Yrs)|Safety population (SP)
65629|NCT02170025|B3|Baseline|Total|Total of all reporting groups
65630|NCT02170025|B2|Baseline|Placebo|Participants received matching placebo tid
65631|NCT02170025|B1|Baseline|Riociguat (Adempas, BAY63-2521)|Participants received 0.5 mg BAY63-2521 three times daily (tid) for 14 days. The dose would be increased to 1 mg BAY63-2521 for an additional 14 days, if this was considered safe and tolerable on the basis of the available data for a given patient.
65632|NCT02170025|P2|Participant Flow|Placebo|Participants received matching placebo tid
65633|NCT02170025|P1|Participant Flow|Riociguat (Adempas, BAY63-2521)|Participants received 0.5 mg BAY63-2521 three times daily (tid) for 14 days. The dose would be increased to 1 mg BAY63-2521 for an additional 14 days, if this was considered safe and tolerable on the basis of the available data for a given patient.
65635|NCT02170025|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received 0.5 mg BAY63-2521 three times daily (tid) for 14 days. The dose would be increased to 1 mg BAY63-2521 for an additional 14 days, if this was considered safe and tolerable on the basis of the available data for a given patient.
65636|NCT02170025|E2|Reported Event|Riociguat (Adempas, BAY63-2521)|Participants received 0.5 mg BAY63-2521 three times daily (tid) for 14 days. The dose would be increased to 1 mg BAY63-2521 for an additional 14 days, if this was considered safe and tolerable on the basis of the available data for a given patient.
65637|NCT02170025|E1|Reported Event|Placebo|Participants received matching placebo tid
65638|NCT02169895|B5|Baseline|Total|Total of all reporting groups
65639|NCT02169895|B4|Baseline|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~Every period with concomitant single oral administration of Prolopa® 100-25"
65640|NCT02169895|B3|Baseline|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~Every period with concomitant single oral administration of Prolopa® 100-25"
65641|NCT02169895|B2|Baseline|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~Every period with concomitant single oral administration of Prolopa® 100-25"
65642|NCT02169895|B1|Baseline|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~Every period with concomitant single oral administration of Prolopa® 100-25"
65643|NCT02169895|P4|Participant Flow|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~Every period with concomitant single oral administration of Prolopa® 100-25~Prolopa®: levodopa/benserazide 100/25 mg"
65644|NCT02169895|P3|Participant Flow|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~Every period with concomitant single oral administration of Prolopa® 100-25~Prolopa®: levodopa/benserazide 100/25 mg"
65645|NCT02169895|P2|Participant Flow|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~Every period with concomitant single oral administration of Prolopa® 100-25~Prolopa®: levodopa/benserazide 100/25 mg"
65646|NCT02169895|P1|Participant Flow|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~Every period with concomitant single oral administration of Prolopa® 100-25~Prolopa®: levodopa/benserazide 100/25 mg"
65647|NCT02169895|O4|Outcome|Placebo Group|"Placebo Group.~with concomitant single oral administration of Prolopa® 100-25"
65648|NCT02169895|O3|Outcome|BIA 9-1067 100 mg Group|"BIA 9-1067 100 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
65649|NCT02169895|O2|Outcome|BIA 9-1067 50 mg Group|"BIA 9-1067 50 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
65650|NCT02169895|O1|Outcome|BIA 9-1067 25 mg Group|"BIA 9-1067 25 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
65651|NCT02169895|O4|Outcome|Placebo Group|"Placebo Group.~with concomitant single oral administration of Prolopa® 100-25"
65652|NCT02169895|O3|Outcome|BIA 9-1067 100 mg Group|"BIA 9-1067 100 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
65653|NCT02169895|O2|Outcome|BIA 9-1067 50 mg Group|"BIA 9-1067 50 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
65654|NCT02169895|O1|Outcome|BIA 9-1067 25 mg Group|"BIA 9-1067 25 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
65655|NCT02169895|O4|Outcome|Placebo Group|"Placebo Group.~with concomitant single oral administration of Prolopa® 100-25"
65656|NCT02169895|O3|Outcome|BIA 9-1067 100 mg Group|"BIA 9-1067 100 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
65657|NCT02169895|O2|Outcome|BIA 9-1067 50 mg Group|"BIA 9-1067 50 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
65658|NCT02169895|O1|Outcome|BIA 9-1067 25 mg Group|"BIA 9-1067 25 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
65659|NCT02169895|E4|Reported Event|Placebo Group|"Placebo Group.~with concomitant single oral administration of Prolopa® 100-25"
65660|NCT02169895|E3|Reported Event|BIA 9-1067 100 mg Group|"BIA 9-1067 100 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
65661|NCT02169895|E2|Reported Event|BIA 9-1067 50 mg Group|"BIA 9-1067 50 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
65662|NCT02169895|E1|Reported Event|BIA 9-1067 25 mg Group|"BIA 9-1067 25 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
65663|NCT02169479|B5|Baseline|Total|Total of all reporting groups
65664|NCT02169479|B4|Baseline|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
65665|NCT02169479|B3|Baseline|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
65666|NCT02169479|B2|Baseline|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
65667|NCT02169479|B1|Baseline|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
65668|NCT02169479|P4|Participant Flow|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
65669|NCT02169479|P3|Participant Flow|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
65670|NCT02169479|P2|Participant Flow|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
65671|NCT02169479|P1|Participant Flow|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
65672|NCT02169479|O4|Outcome|Placebo|Placebo, PLC
65673|NCT02169479|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
65674|NCT02169479|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
65675|NCT02169479|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
65676|NCT02169479|O4|Outcome|Placebo|Placebo, PLC
65677|NCT02169479|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
65678|NCT02169479|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
65679|NCT02169479|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
65680|NCT02169479|O4|Outcome|Placebo|Placebo, PLC
65681|NCT02169479|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
65682|NCT02169479|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
65683|NCT02169479|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
65684|NCT02169479|E4|Reported Event|Placebo|Placebo, PLC
65685|NCT02169479|E3|Reported Event|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
65686|NCT02169479|E2|Reported Event|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
65687|NCT02169479|E1|Reported Event|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
65688|NCT02169466|B5|Baseline|Total|Total of all reporting groups
65689|NCT02169466|B4|Baseline|BIA 9-1067: Placebo, 25, 50, 100|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
65690|NCT02169466|B3|Baseline|BIA 9-1067: 100, Placebo, 25, 50|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
65691|NCT02169466|B2|Baseline|BIA 9-1067: 50, 100, Placebo, 25|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
65692|NCT02169466|B1|Baseline|BIA 9-1067: 25, 50, 100, Placebo|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
65693|NCT02169466|P4|Participant Flow|BIA 9-1067: Placebo, 25, 50, 100|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
65694|NCT02169466|P3|Participant Flow|BIA 9-1067: 100, Placebo, 25, 50|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
65695|NCT02169466|P2|Participant Flow|BIA 9-1067: 50, 100, Placebo, 25|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
65696|NCT02169466|P1|Participant Flow|BIA 9-1067: 25, 50, 100, Placebo|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
65697|NCT02169466|O4|Outcome|Placebo|Placebo, PLC
65698|NCT02169466|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
65699|NCT02169466|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
65700|NCT02169466|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
65701|NCT02169466|O4|Outcome|Placebo|Placebo, PLC Of the initially enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
65702|NCT02169466|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
65703|NCT02169466|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
66413|NCT02163915|O4|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
65704|NCT02169466|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone Of the initially enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
65705|NCT02169466|O4|Outcome|Placebo|Placebo, PLC Of the initially enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
65706|NCT02169466|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
65707|NCT02169466|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
65708|NCT02169466|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone Of the initially enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
65709|NCT02169466|O4|Outcome|Placebo|Placebo, PLC Of the initialy enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
65710|NCT02169466|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
65711|NCT02169466|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
65712|NCT02169466|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone Of the initialy enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
65713|NCT02169466|E4|Reported Event|Placebo|Placebo, PLC
65714|NCT02169466|E3|Reported Event|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
65715|NCT02169466|E2|Reported Event|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
65716|NCT02169466|E1|Reported Event|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
65717|NCT02169453|B5|Baseline|Total|Total of all reporting groups
65718|NCT02169453|B4|Baseline|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~Subjects were to attend four treatment periods and were to receive a different dose of BIA 9-1067 (25 mg, 50 mg and 100 mg) or placebo during each of these treatment periods.~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
65719|NCT02169453|B3|Baseline|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
65720|NCT02169453|B2|Baseline|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
65721|NCT02169453|B1|Baseline|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
65722|NCT02169453|P4|Participant Flow|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~Subjects were to attend four treatment periods and were to receive a different dose of BIA 9-1067 (25 mg, 50 mg and 100 mg) or placebo during each of these treatment periods.~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
65723|NCT02169453|P3|Participant Flow|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
65724|NCT02169453|P2|Participant Flow|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
65725|NCT02169453|P1|Participant Flow|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
65726|NCT02169453|O4|Outcome|Placebo|Placebo, PLC
65727|NCT02169453|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
65728|NCT02169453|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
65729|NCT02169453|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
65730|NCT02169453|O4|Outcome|Placebo|Placebo, PLC
65731|NCT02169453|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
65732|NCT02169453|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
65733|NCT02169453|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
65734|NCT02169453|O4|Outcome|Placebo|Placebo, PLC
65735|NCT02169453|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
65736|NCT02169453|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
65737|NCT02169453|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
65738|NCT02169453|O4|Outcome|Placebo|Placebo, PLC
65739|NCT02169453|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
65740|NCT02169453|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
65741|NCT02169453|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
65742|NCT02169453|O4|Outcome|Placebo|Placebo, PLC
65743|NCT02169453|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
65744|NCT02169453|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
65745|NCT02169453|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
65746|NCT02169453|O4|Outcome|Placebo|Placebo, PLC
65747|NCT02169453|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
65755|NCT02169440|B2|Baseline|Group 2: Warfarin, Then BIA 9-1067 + Warfarin|"Period 1: warfarin Period 2: BIA 9-1067 + warfarin~BIA 9-1067: BIA 9-1067 25 mg~Warfarin: Warfarin 25 mg"
65756|NCT02169440|B1|Baseline|Group 1: BIA 9-1067 + Warfarin, Then Warfarin|"Period 1: BIA 9-1067 + warfarin Period 2: warfarin~BIA 9-1067: BIA 9-1067 25 mg~Warfarin: Warfarin 25 mg"
65757|NCT02169440|P2|Participant Flow|Group 2: Warfarin, Then BIA 9-1067 + Warfarin|"Period 1: warfarin Period 2: BIA 9-1067 + warfarin~BIA 9-1067: BIA 9-1067 25 mg~Warfarin: Warfarin 25 mg"
65758|NCT02169440|P1|Participant Flow|Group 1: BIA 9-1067 + Warfarin, Then Warfarin|"Period 1: BIA 9-1067 + warfarin Period 2: warfarin~BIA 9-1067: BIA 9-1067 25 mg~Warfarin: Warfarin 25 mg"
65759|NCT02169440|O1|Outcome|Warfarin + BIA 9-1067|25 mg warfarin + 25 mg BIA 9-1067
65760|NCT02169440|O1|Outcome|Warfarin + BIA 9-1067|25 mg warfarin + 25 mg BIA 9-1067
65761|NCT02169440|O1|Outcome|Warfarin + BIA 9-1067|25 mg warfarin + 25 mg BIA 9-1067
65762|NCT02169440|O1|Outcome|Warfarin Alone|Warfarin 25 mg
65763|NCT02169440|O1|Outcome|Warfarin Alone|Warfarin 25 mg
65764|NCT02169440|O1|Outcome|Warfarin Alone|Warfarin 25 mg
65765|NCT02169440|O1|Outcome|BIA 9-1067 + Warfarin|BIA 9-1067 25 mg + Warfarin 25 mg
65766|NCT02169440|O1|Outcome|BIA 9-1067 + Warfarin|BIA 9-1067 25 mg + Warfarin 25 mg
65767|NCT02169440|O1|Outcome|BIA 9-1067 + Warfarin|BIA 9-1067 25 mg + Warfarin 25 mg
65768|NCT02169440|E2|Reported Event|Warfarin|Warfarin 25 mg
65769|NCT02169440|E1|Reported Event|BIA 9-1067 + Warfarin|BIA 9-1067 25 mg Warfarin 25 mg
65770|NCT02169427|B1|Baseline|Opicapone (OPC)|"100 mg OPC~OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
65771|NCT02169427|P1|Participant Flow|Opicapone (OPC)|"100 mg OPC~OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
65772|NCT02169427|O1|Outcome|Opicapone (OPC)|"100 mg OPC~OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
65773|NCT02169427|O1|Outcome|Opicapone (OPC)|"100 mg OPC~OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
65774|NCT02169427|O1|Outcome|Opicapone (OPC)|"100 mg OPC~OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
65775|NCT02169427|E1|Reported Event|Opicapone (OPC)|"100 mg OPC~OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
65776|NCT02169414|B5|Baseline|Total|Total of all reporting groups
65777|NCT02169414|B4|Baseline|BIA 9-1067 50 mg|"2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 25 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
65778|NCT02169414|B3|Baseline|BIA 9-1067 15 mg|"3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 5 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
65779|NCT02169414|B2|Baseline|BIA 9-1067 5 mg|"1 capsule of 5 mg + 2 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 5 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
65780|NCT02169414|B1|Baseline|Placebo|"3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
65781|NCT02169414|P4|Participant Flow|Placebo|"3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
65782|NCT02169414|P3|Participant Flow|BIA 9-1067 50 mg|"2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 25 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
65783|NCT02169414|P2|Participant Flow|BIA 9-1067 15 mg|"3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 5 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
65784|NCT02169414|P1|Participant Flow|BIA 9-1067 5 mg|"1 capsule of 5 mg + 2 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 5 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
65785|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 25 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
65786|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
65787|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
65788|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
65965|NCT02168387|O2|Outcome|Continuous High Frequency Oscillator (CHFO)|Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
65789|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 25 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
65790|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
65791|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
65792|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
65793|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 25 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
65794|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
65795|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
65796|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
65797|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 25 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
65798|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
65799|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
65800|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
65801|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 25 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
65802|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
65803|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days. Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone. Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
65804|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
65805|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 25 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
65806|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
65807|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days. Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone. Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
65808|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
65809|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 25 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
65810|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
65811|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days. Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone. Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
65812|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
65813|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 25 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
65814|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
66007|NCT02167893|O1|Outcome|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
65815|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days. Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone. Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
65816|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
65817|NCT02169414|E4|Reported Event|BIA 9-1067 50 mg|"2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 25 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
65818|NCT02169414|E3|Reported Event|BIA 9-1067 15 mg|"3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 5 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
65819|NCT02169414|E2|Reported Event|BIA 9-1067 5 mg|"1 capsule of 5 mg + 2 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 5 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
65820|NCT02169414|E1|Reported Event|Placebo|"3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
65821|NCT02169336|B4|Baseline|Total|Total of all reporting groups
65822|NCT02169336|B3|Baseline|IN Placebo|"IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days.~Intranasal Placebo"
65823|NCT02169336|B2|Baseline|DEX-IN 50mcg|"DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
65824|NCT02169336|B1|Baseline|DEX-IN 35mcg|"DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
65825|NCT02169336|P3|Participant Flow|IN Placebo|"IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days.~Intranasal Placebo"
65826|NCT02169336|P2|Participant Flow|DEX-IN 50mcg|"DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
65827|NCT02169336|P1|Participant Flow|DEX-IN 35mcg|"DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
65828|NCT02169336|O3|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days.~Intranasal Placebo"
65829|NCT02169336|O2|Outcome|DEX-IN 50mcg|"DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
65830|NCT02169336|O1|Outcome|DEX-IN 35mcg|"DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
65831|NCT02169336|E3|Reported Event|IN Placebo|"IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days.~Intranasal Placebo"
65832|NCT02169336|E2|Reported Event|DEX-IN 50mcg|"DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
65833|NCT02169336|E1|Reported Event|DEX-IN 35mcg|"DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
65834|NCT02169115|B4|Baseline|Total|Total of all reporting groups
65835|NCT02169115|B3|Baseline|Placebo|Placebo: Placebo, s.c., every 4 weeks
65836|NCT02169115|B2|Baseline|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
65837|NCT02169115|B1|Baseline|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
65838|NCT02169115|P3|Participant Flow|Placebo|Placebo: Placebo, s.c., every 4 weeks
65839|NCT02169115|P2|Participant Flow|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
65840|NCT02169115|P1|Participant Flow|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
65841|NCT02169115|O3|Outcome|Placebo|Placebo: Placebo, s.c., every 4 weeks
65842|NCT02169115|O2|Outcome|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
65843|NCT02169115|O1|Outcome|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
65844|NCT02169115|E3|Reported Event|Placebo|Placebo: Placebo, s.c., every 4 weeks
65845|NCT02169115|E2|Reported Event|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
65846|NCT02169115|E1|Reported Event|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
65847|NCT02168777|B4|Baseline|Total|Total of all reporting groups
65848|NCT02168777|B3|Baseline|Ph1b-Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
65849|NCT02168777|B2|Baseline|Ph1b-Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
65850|NCT02168777|B1|Baseline|Ph1b-Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
65851|NCT02168777|P3|Participant Flow|Ph1b-Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
65852|NCT02168777|P2|Participant Flow|Ph1b-Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
65853|NCT02168777|P1|Participant Flow|Ph1b-Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
65854|NCT02168777|O3|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
65855|NCT02168777|O2|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
65856|NCT02168777|O1|Outcome|Ph1b-Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
65857|NCT02168777|O3|Outcome|Ph2 - Refametinib/Regorafenib (BC)|Phase 2 part of study: Participants will receive the recommended Phase 2 dose (RP2D) for Refametinib and Regorafenib combination therapy determined in Phase 1b part. Target population for this group will be Her-2 negative breast cancer (BC).
65858|NCT02168777|O2|Outcome|Ph2 - Refametinib/Regorafenib (NSCLC)|Phase 2 part of study: Participants will receive the recommended Phase 2 dose (RP2D) for Refametinib and Regorafenib combination therapy determined in Phase 1b part. Target population for this group will be non-small-cell lung cancer (NSCLC).
65859|NCT02168777|O1|Outcome|Ph2 - Refametinib/Regorafenib (CRC)|Phase 2 part of study: Participants will receive the recommended Phase 2 dose (RP2D) for Refametinib and Regorafenib combination therapy determined in Phase 1b part. Target population for this group will be metastatic colorectal cancer (CRC).
65860|NCT02168777|O3|Outcome|Ph2 - Refametinib/Regorafenib (BC)|Phase 2 part of study: Participants will receive the recommended Phase 2 dose (RP2D) for Refametinib and Regorafenib combination therapy determined in Phase 1b part. Target population for this group will be Her-2 negative breast cancer (BC).
65861|NCT02168777|O2|Outcome|Ph2 - Refametinib/Regorafenib (NSCLC)|Phase 2 part of study: Participants will receive the recommended Phase 2 dose (RP2D) for Refametinib and Regorafenib combination therapy determined in Phase 1b part. Target population for this group will be non-small-cell lung cancer (NSCLC).
65862|NCT02168777|O1|Outcome|Ph2 - Refametinib/Regorafenib (CRC)|Phase 2 part of study: Participants will receive the recommended Phase 2 dose (RP2D) for Refametinib and Regorafenib combination therapy determined in Phase 1b part. Target population for this group will be metastatic colorectal cancer (CRC).
65863|NCT02168777|O3|Outcome|Ph2 - Refametinib/Regorafenib (BC)|Phase 2 part of study: Participants will receive the recommended Phase 2 dose (RP2D) for Refametinib and Regorafenib combination therapy determined in Phase 1b part. Target population for this group will be Her-2 negative breast cancer (BC).
65864|NCT02168777|O2|Outcome|Ph2 - Refametinib/Regorafenib (NSCLC)|Phase 2 part of study: Participants will receive the recommended Phase 2 dose (RP2D) for Refametinib and Regorafenib combination therapy determined in Phase 1b part. Target population for this group will be non-small-cell lung cancer (NSCLC).
65865|NCT02168777|O1|Outcome|Ph2 - Refametinib/Regorafenib (CRC)|Phase 2 part of study: Participants will receive the recommended Phase 2 dose (RP2D) for Refametinib and Regorafenib combination therapy determined in Phase 1b part. Target population for this group will be metastatic colorectal cancer (CRC).
65866|NCT02168777|O3|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
65867|NCT02168777|O2|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
65868|NCT02168777|O1|Outcome|Ph1b-Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
65869|NCT02168777|O3|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
65870|NCT02168777|O2|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
65871|NCT02168777|O1|Outcome|Ph1b-Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
65872|NCT02168777|O3|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
65873|NCT02168777|O2|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
65874|NCT02168777|O1|Outcome|Ph1b-Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
66110|NCT02165826|B3|Baseline|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
65875|NCT02168777|O3|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
65876|NCT02168777|O2|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
65877|NCT02168777|O1|Outcome|Ph1b-Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
65878|NCT02168777|O3|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
65879|NCT02168777|O2|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
65880|NCT02168777|O1|Outcome|Ph1b-Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
65881|NCT02168777|O3|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
65882|NCT02168777|O2|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
65883|NCT02168777|O1|Outcome|Ph1b-Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
65884|NCT02168777|O3|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
65885|NCT02168777|O2|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
65886|NCT02168777|O1|Outcome|Ph1b-Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
65887|NCT02168777|O3|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
65888|NCT02168777|O2|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
65889|NCT02168777|O1|Outcome|Ph1b-Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
65890|NCT02168777|O3|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
65891|NCT02168777|O2|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
65892|NCT02168777|O1|Outcome|Ph1b-Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
65893|NCT02168777|O3|Outcome|Ph2 - Refametinib/Regorafenib (BC)|Phase 2 part of study: Participants will receive the recommended Phase 2 dose (RP2D) for Refametinib and Regorafenib combination therapy determined in Phase 1b part. Target population for this group will be Her-2 negative breast cancer (BC).
65894|NCT02168777|O2|Outcome|Ph2 - Refametinib/Regorafenib (NSCLC)|Phase 2 part of study: Participants will receive the recommended Phase 2 dose (RP2D) for Refametinib and Regorafenib combination therapy determined in Phase 1b part. Target population for this group will be non-small-cell lung cancer (NSCLC).
65895|NCT02168777|O1|Outcome|Ph2 - Refametinib/Regorafenib (CRC)|Phase 2 part of study: Participants will receive the recommended Phase 2 dose (RP2D) for Refametinib and Regorafenib combination therapy determined in Phase 1b part. Target population for this group will be metastatic colorectal cancer (CRC).
65896|NCT02168777|O3|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
65897|NCT02168777|O2|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
65898|NCT02168777|O1|Outcome|Ph1b-Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
65899|NCT02168777|O3|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
65900|NCT02168777|O2|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
65901|NCT02168777|O1|Outcome|Ph1b-Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
65902|NCT02168777|O3|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
65903|NCT02168777|O2|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
65904|NCT02168777|O1|Outcome|Ph1b-Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
65905|NCT02168777|O3|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
65906|NCT02168777|O2|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
65907|NCT02168777|O1|Outcome|Ph1b-Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
65908|NCT02168777|O3|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
65909|NCT02168777|O2|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
65910|NCT02168777|O1|Outcome|Ph1b-Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
65911|NCT02168777|O3|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
65912|NCT02168777|O2|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
65913|NCT02168777|O1|Outcome|Ph1b-Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
65914|NCT02168777|O3|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
65915|NCT02168777|O2|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
65916|NCT02168777|O1|Outcome|Ph1b-Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
65917|NCT02168777|O3|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
65966|NCT02168387|O1|Outcome|Medication|Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.
65918|NCT02168777|O2|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
65919|NCT02168777|O1|Outcome|Ph1b-Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
65920|NCT02168777|O3|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
65921|NCT02168777|O2|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
65922|NCT02168777|O1|Outcome|Ph1b-Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
65923|NCT02168777|O3|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
65924|NCT02168777|O2|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
65925|NCT02168777|O1|Outcome|Ph1b-Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
65926|NCT02168777|E3|Reported Event|Ph1b - Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
65927|NCT02168777|E2|Reported Event|Ph1b - Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
65928|NCT02168777|E1|Reported Event|Ph1b - Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
65929|NCT02168491|B1|Baseline|Lixisenatide With Basal Insulin (LixiBIT)|Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
65930|NCT02168491|P1|Participant Flow|Lixisenatide With Basal Insulin (LixiBIT)|"Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide~Lixisenatide: Patients will be switched to basal insulin glargine (Lantus, once daily in the morning) and GLP-1 receptor agonist Lixisenatide (Lyxumia, once daily in the morning before breakfast; days 1-14 10 µg thereafter 20 µg). The (mean) daily dose of premixed insulin will be calculated based on the records of the run in period. The initial dose of insulin glargine will be adjusted at about 60% of the daily insulin dose of premixed insulin. This is based on the observed reduction of required insulin dose described in recent literature upon initiation with a GLP-1 agonist.~Insulin glargine: Patients will be switched to basal insulin glargine (Lantus, once daily in the morning) and GLP-1 receptor agonist Lixisenatide (Lyxumia, once daily in the morning before breakfast; days 1-14 10 µg thereafter 20 µg). The (mean) daily dose of"
65931|NCT02168491|O1|Outcome|Lixisenatide With Basal Insulin (LixiBIT)|Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
65932|NCT02168491|O1|Outcome|Lixisenatide With Basal Insulin (LixiBIT)|Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
65933|NCT02168491|O1|Outcome|Lixisenatide With Basal Insulin (LixiBIT)|Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
65934|NCT02168491|E1|Reported Event|Lixisenatide With Basal Insulin (LixiBIT)|Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
65935|NCT02168478|B1|Baseline|Patch Test Group|"All subjects are patched with the following: 1.Neo-Synalar Cream 2.Sodium Lauryl Sulfate and 3. Saline.~All test material is applied to the absorbent pad and allowed to remain in direct skin contact for a period of 48 hours.~Neo-Synalar Cream: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied to upper back between the scapulae.~Sodium Lauryl Sulfate Aqueous Solution (0.40%): Approximately 0.2 ml of the positive , 0.40% aqueous solution of sodium lauryl sulfate applied to the absorbent pad portion of a semi-occlusive dressing and applied to upper back between the scapulae.~Saline: Saline is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae."
65967|NCT02168387|O2|Outcome|Continuous High Frequency Oscillator (CHFO)|Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
65968|NCT02168387|O1|Outcome|Medication|Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.
65969|NCT02168387|E2|Reported Event|Continuous High Frequency Oscillator (CHFO)|Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
65936|NCT02168478|P1|Participant Flow|Patch Test Group|"All subjects are patched with the following: 1.Neo-Synalar Cream 2.Sodium Lauryl Sulfate and 3. Saline.~Test material is applied to the absorbent pad and allowed to remain in direct skin contact for a period of 48 hours.~Neo-Synalar Cream: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.~Sodium Lauryl Sulfate Aqueous Solution (0.40%): Approximately 0.2 ml of the positive , 0.40% aqueous solution of sodium lauryl sulfate is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.~Saline: Saline is applied to the absorbent pad portion of a"
65937|NCT02168478|O1|Outcome|Patch Test Group|"Neo-Synalar Cream: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.~Sodium Lauryl Sulfate Aqueous Solution (0.40%): Approximately 0.2 mL of the positive, 0.40% aqueous solution of sodium lauryl sulfate is applied to the absorbent pad portion of an occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.~Saline: Approximately 0.2 mL of saline is applied to the absorbent pad portion of an occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours."
65938|NCT02168478|E1|Reported Event|Patch Test Group|"All subjects are patched with the following: 1.Neo-Synalar Cream 2.Sodium Lauryl Sulfate and 3. Saline. Test material is applied to the absorbent pad and allowed to remain in direct skin contact for a period of 48 hours.~Neo-Synalar Cream: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae.~Sodium Lauryl Sulfate Aqueous Solution (0.40%): Approximately 0.2 ml of the positive , 0.40% aqueous solution of sodium lauryl sulfate is applied to the absorbent pad portion of an occlusive dressing and applied as received to the upper back between the scapulae.~Saline: Approximately 0.2 ml of the saline is applied to the absorbent pad portion of an occlusive dressing and applied as received to the upper back between the scapulae."
65939|NCT02168439|B3|Baseline|Total|Total of all reporting groups
65940|NCT02168439|B2|Baseline|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram~Midazolam: ."
65941|NCT02168439|B1|Baseline|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once~Dexmedetomidine: ."
65942|NCT02168439|P2|Participant Flow|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram~Midazolam: 20 patients enrolled, 18 underwent analysis"
65943|NCT02168439|P1|Participant Flow|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once~Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
65944|NCT02168439|O2|Outcome|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram~Midazolam: 20 patients enrolled, 18 underwent analysis"
65945|NCT02168439|O1|Outcome|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once~Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
65946|NCT02168439|O2|Outcome|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram~Midazolam: 20 patients enrolled, 18 underwent analysis"
65947|NCT02168439|O1|Outcome|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once~Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
65948|NCT02168439|O2|Outcome|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram~Midazolam: 20 patients enrolled, 18 underwent analysis"
65949|NCT02168439|O1|Outcome|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once~Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
65950|NCT02168439|O2|Outcome|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram~Midazolam: 20 patients enrolled, 18 underwent analysis"
65951|NCT02168439|O1|Outcome|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once~Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
65952|NCT02168439|O2|Outcome|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram~Midazolam: 20 patients enrolled, 18 underwent analysis"
65953|NCT02168439|O1|Outcome|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once~Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
65954|NCT02168439|O2|Outcome|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram~Midazolam: 20 patients enrolled, 18 underwent analysis"
65955|NCT02168439|O1|Outcome|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once~Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
65956|NCT02168439|E2|Reported Event|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram~Midazolam: 20 patients enrolled, 18 underwent analysis"
65957|NCT02168439|E1|Reported Event|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once~Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
65958|NCT02168387|B3|Baseline|Total|Total of all reporting groups
65959|NCT02168387|B2|Baseline|Continuous High Frequency Oscillator (CHFO)|Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
65960|NCT02168387|B1|Baseline|Medication|Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.
65961|NCT02168387|P2|Participant Flow|Continuous High Frequency Oscillator (CHFO)|"Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.~continuous high frequency oscillator (CHFO)"
65962|NCT02168387|P1|Participant Flow|Medication|"Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.~Acetylcysteine~dornase alfa"
65963|NCT02168387|O2|Outcome|Continuous High Frequency Oscillator (CHFO)|Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
65964|NCT02168387|O1|Outcome|Medication|Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.
66469|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
65970|NCT02168387|E1|Reported Event|Medication|Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.
65971|NCT02168361|B3|Baseline|Total|Total of all reporting groups
65972|NCT02168361|B2|Baseline|Interferon-containing Arm|
65973|NCT02168361|B1|Baseline|Oral Therapy Arm|
65974|NCT02168361|P2|Participant Flow|Interferon-containing Arm|Peginterferon/ribavirin/sofosbuvir
65975|NCT02168361|P1|Participant Flow|All Oral Therapy|Simeprevir-sofosbuvir
65976|NCT02168361|O2|Outcome|Interferon-containing Arm|Peginterferon/ribavirin/sofosbuvir
65977|NCT02168361|O1|Outcome|All Oral Therapy|Simeprevir-sofosbuvir
65978|NCT02168361|O2|Outcome|Interferon-containing Arm|Peginterferon/ribavirin/sofosbuvir
65979|NCT02168361|O1|Outcome|All Oral Therapy|Simeprevir-sofosbuvir
65980|NCT02168361|E2|Reported Event|Interferon-containing|
65981|NCT02168361|E1|Reported Event|All Oral|
65982|NCT02168309|B3|Baseline|Total|Total of all reporting groups
65983|NCT02168309|B2|Baseline|Nifedipine|"Nifedpine XL starting at dose 30mg PO daily~Nifedipine: Titrate up to achieve blood pressure control"
65984|NCT02168309|B1|Baseline|Labetalol|"Labetalol 200mg PO BID starting dose~Labetalol: Titrate up for blood pressure control"
65985|NCT02168309|P2|Participant Flow|Nifedipine|"Nifedpine XL starting at dose 30mg PO daily~Nifedipine: Titrate up to achieve blood pressure control"
65986|NCT02168309|P1|Participant Flow|Labetalol|"Labetalol 200mg PO BID starting dose~Labetalol: Titrate up for blood pressure control"
65987|NCT02168309|O2|Outcome|Nifedipine|"Nifedpine XL starting at dose 30mg PO daily~Nifedipine: Titrate up to achieve blood pressure control"
65988|NCT02168309|O1|Outcome|Labetalol|"Labetalol 200mg PO BID starting dose~Labetalol: Titrate up for blood pressure control"
65989|NCT02168309|O2|Outcome|Nifedipine|"Nifedpine XL starting at dose 30mg PO daily~Nifedipine: Titrate up to achieve blood pressure control"
65990|NCT02168309|O1|Outcome|Labetalol|"Labetalol 200mg PO BID starting dose~Labetalol: Titrate up for blood pressure control"
65991|NCT02168309|E2|Reported Event|Nifedipine|"Nifedpine XL starting at dose 30mg PO daily~Nifedipine: Titrate up to achieve blood pressure control"
65992|NCT02168309|E1|Reported Event|Labetalol|"Labetalol 200mg PO BID starting dose~Labetalol: Titrate up for blood pressure control"
65993|NCT02168270|B1|Baseline|Treatment (Ascorbic Acid, Temozolomide)|"Patients receive ascorbic acid IV over 90-120 minutes three times per week and temozolomide orally days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~ascorbic acid: Given IV~temozolomide: Given PO~quality-of-life assessment: Ancillary studies~laboratory biomarker analysis: Correlative studies"
65994|NCT02168270|P1|Participant Flow|Treatment (Ascorbic Acid, Temozolomide)|"Patients receive ascorbic acid IV over 90-120 minutes three times per week and temozolomide orally days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~ascorbic acid: Given IV~temozolomide: Given PO~quality-of-life assessment: Ancillary studies~laboratory biomarker analysis: Correlative studies"
65995|NCT02168270|O1|Outcome|Treatment (Ascorbic Acid, Temozolomide)|"Patients receive ascorbic acid IV over 90-120 minutes three times per week and temozolomide orally days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~ascorbic acid: Given IV~temozolomide: Given PO~quality-of-life assessment: Ancillary studies~laboratory biomarker analysis: Correlative studies"
65996|NCT02168270|O1|Outcome|Treatment (Ascorbic Acid, Temozolomide)|"Patients receive ascorbic acid IV over 90-120 minutes three times per week and temozolomide orally days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~ascorbic acid: Given IV~temozolomide: Given PO~quality-of-life assessment: Ancillary studies~laboratory biomarker analysis: Correlative studies"
65997|NCT02168270|O1|Outcome|Treatment (Ascorbic Acid, Temozolomide)|"Patients receive ascorbic acid IV over 90-120 minutes three times per week and temozolomide orally days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~ascorbic acid: Given IV~temozolomide: Given PO~quality-of-life assessment: Ancillary studies~laboratory biomarker analysis: Correlative studies"
65998|NCT02168270|O1|Outcome|Treatment (Ascorbic Acid, Temozolomide)|"Patients receive ascorbic acid IV over 90-120 minutes three times per week and temozolomide orally days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~ascorbic acid: Given IV~temozolomide: Given PO~quality-of-life assessment: Ancillary studies~laboratory biomarker analysis: Correlative studies"
65999|NCT02168270|E1|Reported Event|Treatment (Ascorbic Acid, Temozolomide)|"Patients receive ascorbic acid IV over 90-120 minutes three times per week and temozolomide orally days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~ascorbic acid: Given IV~temozolomide: Given PO~quality-of-life assessment: Ancillary studies~laboratory biomarker analysis: Correlative studies"
66000|NCT02167893|B1|Baseline|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
66001|NCT02167893|P1|Participant Flow|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
66002|NCT02167893|O1|Outcome|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
66003|NCT02167893|O1|Outcome|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
66004|NCT02167893|O1|Outcome|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
66005|NCT02167893|O1|Outcome|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
66006|NCT02167893|O1|Outcome|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
66008|NCT02167893|E1|Reported Event|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
66009|NCT02167867|B3|Baseline|Total|Total of all reporting groups
66010|NCT02167867|B2|Baseline|Treatment Subject Group|Treatment subjects received 6 40-minute evenly spaced treatments to the hips, waist and thighs (20 minutes to the front side and 20 minutes to the back side) with the ZERONA Z6 over 2 consecutive weeks. The ZERONA Z6 contains 6 17.25 milliWatts (mW) 635 nanometers (nm) light-emitting diodes.
66011|NCT02167867|B1|Baseline|Lay End Users|Employees of the test sites (that were fitness centers or spas) who were provided with a User's Manual to operate the ZERONA Z6 to administer 6 40-minute evenly spaced treatments over 2 consecutive weeks to the front and back of the waist, hips and thighs of one Treatment Subject.
66012|NCT02167867|P2|Participant Flow|Treatment Subject Group|Subjects who received active treatments with the study device administered by the Lay End Users.
66013|NCT02167867|P1|Participant Flow|Lay End Users|Employees of the test sites that were fitness centers or spas who were provided with a User's Manual to operate the ZERONA Z6 to administer 6 40-minute evenly spaced treatments over 2 consecutive weeks to the front and back of the waist, hips and thighs of a Treatment Subject.
66014|NCT02167867|O1|Outcome|Treatment Subject Group|Individuals who got the active treatments with the ZERONA Z6.
66015|NCT02167867|O1|Outcome|Lay End Users|Employees of the test sites that were fitness centers or spas who were provided with a User's Manual to operate the ZERONA Z6 to administer 6 40-minute evenly spaced treatments over 2 consecutive weeks to the front and back of the waist. hips and thighs.
66016|NCT02167867|O1|Outcome|Lay End Users|Employees of the test sites that were fitness centers or spas who were provided with a User's Manual to operate the ZERONA Z6 to administer 6 40-minute evenly spaced treatments over 2 consecutive weeks to the front and back of the waist. hips and thighs.
66017|NCT02167867|E1|Reported Event|ZERONA Z6|"ZERONA Z6 contains 6 17.25 milliWatts (mW) 635 nanometers (nm) light-emitting diodes. 6 40-minute evenly spaced treatments are administered over 2 consecutive weeks.~ZERONA Z6: 20 minutes of treatment to the front side of the waist, hips and thighs and 20 minutes of treatment to the back side of the waist, hips and thighs."
66018|NCT02167815|B3|Baseline|Total|Total of all reporting groups
66019|NCT02167815|B2|Baseline|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
66020|NCT02167815|B1|Baseline|Standard Care|"standard care ( such as alginate, hydrofiber or other treatment)~standard care"
66021|NCT02167815|P2|Participant Flow|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
66022|NCT02167815|P1|Participant Flow|Standard Care|"standard care ( such as alginate, hydrofiber or other treatment)~standard care"
66023|NCT02167815|O1|Outcome|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
66024|NCT02167815|O2|Outcome|Standard Care|observation group, treated according to investigation sites, standard care
66025|NCT02167815|O1|Outcome|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
66026|NCT02167815|O2|Outcome|Standard Care|observation group, treated according to investigation sites standard care
66027|NCT02167815|O1|Outcome|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
66028|NCT02167815|O2|Outcome|Standard Care|observation group, treating according to investigation sites standard care
66029|NCT02167815|O1|Outcome|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
66030|NCT02167815|E2|Reported Event|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
66031|NCT02167815|E1|Reported Event|Standard Care|"standard care ( such as alginate, hydrofiber or other treatment)~standard care"
66032|NCT02167217|B1|Baseline|Oral Prednisolone|"Oral Prednisolone 5mg/kg/ day on two consecutive days, Friday and Saturday with breakfast~Prednisolone: Prednisolone (5mg per kg )will be taken on two consecutive days, Friday and Saturday mornings each week with breakfast~Twenty-five steroid naïve boys four to 30 months of age with genetically confirmed Duchenne Muscular Dystrophy (DMD) were enrolled. 25 infants and boys were enrolled and 23 completed the study. One boy was lost to follow-up and one discontinued treatment after six months secondary to side effects."
66033|NCT02167217|P1|Participant Flow|Oral Prednisolone|"Oral Prednisolone 5mg/kg/ day on two consecutive days, Friday and Saturday with breakfast~Prednisolone: Prednisolone (5mg per kg )will be taken on two consecutive days, Friday and Saturday mornings each week with breakfast"
66034|NCT02167217|O1|Outcome|Oral Prednisolone|"Oral Prednisolone 5mg/kg/ day on two consecutive days, Friday and Saturday with breakfast~Prednisolone: Prednisolone (5mg per kg )will be taken on two consecutive days, Friday and Saturday mornings each week with breakfast"
66035|NCT02167217|E1|Reported Event|Oral Prednisolone|"Oral Prednisolone 5mg/kg/ day on two consecutive days, Friday and Saturday with breakfast~Prednisolone: Prednisolone (5mg per kg )will be taken on two consecutive days, Friday and Saturday mornings each week with breakfast"
66036|NCT02167139|B3|Baseline|Total|Total of all reporting groups
66037|NCT02167139|B2|Baseline|Humira (Adalimumab)|"Humira 40 mg every other week via subcutaneous injection~Humira (adalimumab)~SB5 (proposed biosimilar to adalimumab)"
66038|NCT02167139|B1|Baseline|SB5 (Proposed Biosimilar to Adalimumab)|"SB5 40 mg every other week via subcutaneous injection~SB5 (proposed biosimilar to adalimumab)"
66039|NCT02167139|P4|Participant Flow|Humira (Adalimumab), Continue as Humira|From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.
66040|NCT02167139|P3|Participant Flow|Humira (Adalimumab), Switch to SB5|From Week 24, SB5 40 mg (Humira®/SB5) every other week up to Week 50.
66041|NCT02167139|P2|Participant Flow|Humira (Adalimumab)|Humira 40 mg every other week via subcutaneous injection to Week 24, then randomised again in a 1:1 ratio to either continue on Humira® 40 mg (Humira®/Humira®) or be transitioned to SB5 40 mg (Humira®/SB5) every other week up to Week 50.
66042|NCT02167139|P1|Participant Flow|SB5 (Proposed Biosimilar to Adalimumab)|SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
66043|NCT02167139|O5|Outcome|Humira (Adalimumab), Continue as Humira at Week 52|From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.
66044|NCT02167139|O4|Outcome|Humira (Adalimumab), Switch to SB5 at Week 52|From Week 24, SB5 40 mg (Humira®/SB5) every other week up to Week 50.
66045|NCT02167139|O3|Outcome|SB5 (Proposed Biosimilar to Adalimumab) at Week 52|SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
66046|NCT02167139|O2|Outcome|Humira (Adalimumab) at Week 24|Humira 40 mg every other week via subcutaneous injection to Week 24, then randomised again in a 1:1 ratio to either continue on Humira® 40 mg (Humira®/Humira®) or be transitioned to SB5 40 mg (Humira®/SB5) every other week up to Week 50.
66047|NCT02167139|O1|Outcome|SB5 (Proposed Biosimilar to Adalimumab) at Week 24|SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
66048|NCT02167139|O3|Outcome|Humira (Adalimumab), Continue as Humira|From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.
66049|NCT02167139|O2|Outcome|Humira (Adalimumab), Switch to SB5|From Week 24, SB5 40 mg (Humira®/SB5) every other week up to Week 50.
66050|NCT02167139|O1|Outcome|SB5 (Proposed Biosimilar to Adalimumab)|SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
66051|NCT02167139|O2|Outcome|Humira (Adalimumab)|Humira 40 mg every other week via subcutaneous injection up to Week 24
66052|NCT02167139|O1|Outcome|SB5 (Proposed Biosimilar to Adalimumab)|SB5 40 mg every other week via subcutaneous injection up to Week 24
66053|NCT02167139|E2|Reported Event|Humira (Adalimumab)|Humira 40 mg every other week via subcutaneous injection to Week 24, then randomised again in a 1:1 ratio to either continue on Humira® 40 mg (Humira®/Humira®) or be transitioned to SB5 40 mg (Humira®/SB5) every other week up to Week 50.
66054|NCT02167139|E1|Reported Event|SB5 (Proposed Biosimilar to Adalimumab)|SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
66055|NCT02166697|B1|Baseline|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
66056|NCT02166697|P1|Participant Flow|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
66057|NCT02166697|O1|Outcome|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
66058|NCT02166697|O1|Outcome|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
66059|NCT02166697|O1|Outcome|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
66060|NCT02166697|O1|Outcome|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
66061|NCT02166697|O1|Outcome|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
66062|NCT02166697|O1|Outcome|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
66063|NCT02166697|E1|Reported Event|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
66064|NCT02166476|B3|Baseline|Total|Total of all reporting groups
66065|NCT02166476|B2|Baseline|Piperacillin-Tazobactam|Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g), infused in 100 mL normal saline, administered IV over 30 minutes, q8h, with 250 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV piperacillin-tazobactam plus saline, if clinically indicated. Total treatment was 10 days, unless a participant had baseline bacteremia where up to 14 days of therapy could be administered IV.
66066|NCT02166476|B1|Baseline|Meropenem-Vaborbactam|Meropenem-vaborbactam (meropenem 2 g plus vaborbactam 2 g), infused in 250 mL normal saline, administered IV over 3 hours, q8h, with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Total treatment was 10 days, unless a participant had baseline bacteremia where up to 14 days of therapy could be administered IV.
66067|NCT02166476|P2|Participant Flow|Piperacillin-Tazobactam|Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g), infused in 100 mL normal saline, administered IV over 30 minutes, q8h, with 250 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV piperacillin-tazobactam plus saline, if clinically indicated. Total treatment was 10 days, unless a participant had baseline bacteremia where up to 14 days of therapy could be administered IV.
66068|NCT02166476|P1|Participant Flow|Meropenem-Vaborbactam|Meropenem-vaborbactam (meropenem 2 grams [g] plus vaborbactam 2 g), infused in 250 milliliters (mL) normal saline, administered intravenously (IV) over 3 hours, every 8 hours (q8h), with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-milligram (mg) dose every 24 hours (q24h) after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Total treatment was 10 days, unless a participant had baseline bacteremia where up to 14 days of therapy could be administered IV.
66069|NCT02166476|O1|Outcome|Meropenem-Vaborbactam|"Meropenem-vaborbactam (meropenem 2 g plus vaborbactam 2 g), infused in 250 mL normal saline, administered IV over 3 hours, q8h, with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.~AUC0-24 Steady-State estimates not available for 2 participants who received >3 doses."
66070|NCT02166476|O2|Outcome|Piperacillin-Tazobactam|Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g), infused in 100 mL normal saline, administered IV over 30 minutes, q8h, with 250 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV piperacillin-tazobactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66071|NCT02166476|O1|Outcome|Meropenem-Vaborbactam|Meropenem-vaborbactam (meropenem 2 grams [g] plus vaborbactam 2 g), infused in 250 milliliters (mL) normal saline, administered intravenously (IV) over 3 hours, every 8 hours (q8h), with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-milligram (mg) dose every 24 hours (q24h) after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66072|NCT02166476|O2|Outcome|Piperacillin-Tazobactam|Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g), infused in 100 mL normal saline, administered IV over 30 minutes, q8h, with 250 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV piperacillin-tazobactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66414|NCT02163915|O3|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
66415|NCT02163915|O2|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
66073|NCT02166476|O1|Outcome|Meropenem-Vaborbactam|Meropenem-vaborbactam (meropenem 2 grams [g] plus vaborbactam 2 g), infused in 250 milliliters (mL) normal saline, administered intravenously (IV) over 3 hours, every 8 hours (q8h), with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-milligram (mg) dose every 24 hours (q24h) after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66074|NCT02166476|O2|Outcome|Piperacillin-Tazobactam|Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g), infused in 100 mL normal saline, administered IV over 30 minutes, q8h, with 250 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV piperacillin-tazobactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66075|NCT02166476|O1|Outcome|Meropenem-Vaborbactam|Meropenem-vaborbactam (meropenem 2 grams [g] plus vaborbactam 2 g), infused in 250 milliliters (mL) normal saline, administered intravenously (IV) over 3 hours, every 8 hours (q8h), with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-milligram (mg) dose every 24 hours (q24h) after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66076|NCT02166476|O2|Outcome|Piperacillin-Tazobactam|Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g), infused in 100 mL normal saline, administered IV over 30 minutes, q8h, with 250 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV piperacillin-tazobactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66077|NCT02166476|O1|Outcome|Meropenem-Vaborbactam|Meropenem-vaborbactam (meropenem 2 g plus vaborbactam 2 g), infused in 250 mL normal saline, administered IV over 3 hours, q8h, with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66078|NCT02166476|O2|Outcome|Piperacillin-Tazobactam|Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g), infused in 100 mL normal saline, administered IV over 30 minutes, q8h, with 250 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV piperacillin-tazobactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66079|NCT02166476|O1|Outcome|Meropenem-Vaborbactam|Meropenem-vaborbactam (meropenem 2 g plus vaborbactam 2 g), infused in 250 mL normal saline, administered IV over 3 hours, q8h, with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66080|NCT02166476|O2|Outcome|Piperacillin-Tazobactam|Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g), infused in 100 mL normal saline, administered IV over 30 minutes, q8h, with 250 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV piperacillin-tazobactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66081|NCT02166476|O1|Outcome|Meropenem-Vaborbactam|Meropenem-vaborbactam (meropenem 2 g plus vaborbactam 2 g), infused in 250 mL normal saline, administered IV over 3 hours, q8h, with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66082|NCT02166476|O2|Outcome|Piperacillin-Tazobactam|Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g), infused in 100 mL normal saline, administered IV over 30 minutes, q8h, with 250 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV piperacillin-tazobactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66083|NCT02166476|O1|Outcome|Meropenem-Vaborbactam|Meropenem-vaborbactam (meropenem 2 g plus vaborbactam 2 g), infused in 250 mL normal saline, administered IV over 3 hours, q8h, with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66084|NCT02166476|O2|Outcome|Piperacillin-Tazobactam|Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g), infused in 100 mL normal saline, administered IV over 30 minutes, q8h, with 250 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV piperacillin-tazobactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66085|NCT02166476|O1|Outcome|Meropenem-Vaborbactam|Meropenem-vaborbactam (meropenem 2 g plus vaborbactam 2 g), infused in 250 mL normal saline, administered IV over 3 hours, q8h, with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66086|NCT02166476|O2|Outcome|Piperacillin-Tazobactam|Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g), infused in 100 mL normal saline, administered IV over 30 minutes, q8h, with 250 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after piperacillin-tazobactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66087|NCT02166476|O1|Outcome|Meropenem-Vaborbactam|Meropenem-vaborbactam (meropenem 2 g plus vaborbactam 2 g), infused in 250 mL normal saline, administered IV over 3 hours, q8h, with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66088|NCT02166476|O2|Outcome|Piperacillin-Tazobactam|Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g), infused in 100 mL normal saline, administered IV over 30 minutes, q8h, with 250 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV piperacillin-tazobactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66141|NCT02165826|O3|Outcome|Roflumilast 500 μg OD_Down Titration Period|Participants in the roflumilast 500 μg once daily (OD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66089|NCT02166476|O1|Outcome|Meropenem-Vaborbactam|Meropenem-vaborbactam (meropenem 2 g plus vaborbactam 2 g), infused in 250 mL normal saline, administered IV over 3 hours, q8h, with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66090|NCT02166476|O2|Outcome|Piperacillin-Tazobactam|Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g), infused in 100 mL normal saline, administered IV over 30 minutes, q8h, with 250 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV piperacillin-tazobactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66091|NCT02166476|O1|Outcome|Meropenem-Vaborbactam|Meropenem-vaborbactam (meropenem 2 g plus vaborbactam 2 g), infused in 250 mL normal saline, administered IV over 3 hours, q8h, with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66092|NCT02166476|O2|Outcome|Piperacillin-Tazobactam|Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g), infused in 100 mL normal saline, administered IV over 30 minutes, q8h, with 250 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV piperacillin-tazobactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66093|NCT02166476|O1|Outcome|Meropenem-Vaborbactam|Meropenem-vaborbactam (meropenem 2 g plus vaborbactam 2 g), infused in 250 mL normal saline, administered IV over 3 hours, q8h, with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66094|NCT02166476|O2|Outcome|Piperacillin-Tazobactam|Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g), infused in 100 mL normal saline, administered IV over 30 minutes, q8h, with 250 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV piperacillin-tazobactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66095|NCT02166476|O1|Outcome|Meropenem-Vaborbactam|Meropenem-vaborbactam (meropenem 2 g plus vaborbactam 2 g), infused in 250 mL normal saline, administered IV over 3 hours, q8h, with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66096|NCT02166476|O2|Outcome|Piperacillin-Tazobactam|Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g), infused in 100 mL normal saline, administered IV over 30 minutes, q8h, with 250 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV piperacillin-tazobactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66097|NCT02166476|O1|Outcome|Meropenem-Vaborbactam|Meropenem-vaborbactam (meropenem 2 g plus vaborbactam 2 g), infused in 250 mL normal saline, administered IV over 3 hours, q8h, with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
66098|NCT02166476|E2|Reported Event|Piperacillin-Tazobactam|Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g), infused in 100 mL normal saline, administered IV over 30 minutes, q8h, with 250 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV piperacillin-tazobactam plus saline, if clinically indicated. Total treatment was 10 days, unless a participant had baseline bacteremia where up to 14 days of therapy could be administered IV.
66099|NCT02166476|E1|Reported Event|Meropenem-Vaborbactam|Meropenem-vaborbactam (meropenem 2 g plus vaborbactam 2 g), infused in 250 mL normal saline, administered IV over 3 hours, q8h, with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Total treatment was 10 days, unless a participant had baseline bacteremia where up to 14 days of therapy could be administered IV.
66100|NCT02166346|B1|Baseline|Whole Study Population|This is a crossover trial. At baseline prior to randomization into an intervention, the baseline measures are provided.
66101|NCT02166346|P2|Participant Flow|Placebo Then Dalfampridine|"All subjects were randomized for the first double-blinded 8-week part of the study to the placebo arm. Then subjects were crossed over to the dalfampridine arm for another 8 weeks.~Placebo: Placebo pill 1 tablet twice daily for 8 weeks Dalfampridine: Dalfampridine 10 mg twice daily for 8 weeks"
66102|NCT02166346|P1|Participant Flow|Dalfampridine Then Placebo|"All subjects were randomized for the first double-blinded 8-week part of the study to the dalfampridine group. Then subjects were crossed over to the placebo arm for another 8 weeks.~Dalfampridine: Dalfampridine 10 mg twice daily for 8 weeks Placebo: Placebo pill 1 tablet twice daily for 8 weeks"
66103|NCT02166346|O2|Outcome|Placebo|"Placebo controlled arm.~Placebo: Placebo pill 1 tablet twice daily for 8 weeks"
66104|NCT02166346|O1|Outcome|Dalfampridine|"All subjects will be randomized for the first double-blinded 8-week part of the study with 25-foot timed walking assessments every 2 weeks. Then subjects will be crossed over to the other therapy (drug or placebo) for another 8 weeks.~Dalfampridine: Dalfampridine 10 mg twice daily for 8 weeks"
66105|NCT02166346|O2|Outcome|Placebo|"Placebo controlled arm.~Placebo: Placebo pill 1 tablet twice daily for 8 weeks"
66106|NCT02166346|O1|Outcome|Dalfampridine|"All subjects will be randomized for the first double-blinded 8-week part of the study with 25-foot timed walking assessments every 2 weeks. Then subjects will be crossed over to the other therapy (drug or placebo) for another 8 weeks.~Dalfampridine: Dalfampridine 10 mg twice daily for 8 weeks"
66107|NCT02166346|E2|Reported Event|Placebo|"Placebo controlled arm.~Placebo: Placebo pill 1 tablet twice daily for 8 weeks"
66108|NCT02166346|E1|Reported Event|Dalfampridine|"All subjects will be randomized for the first double-blinded 8-week part of the study with 25-foot timed walking assessments every 2 weeks. Then subjects will be crossed over to the other therapy (drug or placebo) for another 8 weeks.~Dalfampridine: Dalfampridine 10 mg twice daily for 8 weeks"
66109|NCT02165826|B4|Baseline|Total|Total of all reporting groups
66111|NCT02165826|B2|Baseline|Roflumilast 500 μg EOD Then 500 μg OD|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66112|NCT02165826|B1|Baseline|Roflumilast 250 μg OD Then 500 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66113|NCT02165826|P3|Participant Flow|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
66114|NCT02165826|P2|Participant Flow|Roflumilast 500 μg EOD Then 500 μg OD|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66115|NCT02165826|P1|Participant Flow|Roflumilast 250 μg OD Then 500 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66116|NCT02165826|O2|Outcome|Roflumilast 500 μg OD_CFB in FEV1 @ Week 12|Roflumilast 500 μg, tablets, orally, once daily (OD) for 12 weeks. Results for Change from Baseline in FEV1 at Week 12.
66117|NCT02165826|O1|Outcome|Roflumilast 500 μg OD_CFB in FEV1 @ Week 4|Roflumilast 500 μg, tablets, orally, once daily (OD) for 12 weeks. Results for Change from Baseline in FEV1 at Week 4.
66118|NCT02165826|O3|Outcome|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
66119|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD|Roflumilast 500 μg, orally, every other day (EOD) at least 1 dose in the Main Period
66120|NCT02165826|O1|Outcome|Roflumilast 250 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
66121|NCT02165826|O2|Outcome|Roflumilast 250 μg OD|Roflumilast 500 μg at least one dose in the Main Period followed by Roflumilast 250 μg tablets, orally, once daily in the Down -Titration Period.
66122|NCT02165826|O1|Outcome|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
66123|NCT02165826|O4|Outcome|Roflumilast 250 µg Down-Titration|250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66124|NCT02165826|O3|Outcome|Roflumilast 250 μg OD|Roflumilast 250 μg tablets, orally, once daily in the Main Period.
66125|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD|Roflumilast 500 μg, tablets, orally, every other day (EOD) in the Main Period.
66126|NCT02165826|O1|Outcome|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
66127|NCT02165826|O2|Outcome|All PK Participants_Roflumilast N-oxide|All PK participants who received any dose of rofumilast. Results for roflumilast N-oxide.
66128|NCT02165826|O1|Outcome|All PK Participants_Roflumilast|All PK participants who received any dose of roflumilast. Results for roflumilast.
66129|NCT02165826|O2|Outcome|All PK Participants_Roflumilast N-oxide|All PK participants who received any dose of rofumilast. Results for roflumilast N-oxide.
66130|NCT02165826|O1|Outcome|All PK Participants_Roflumilast|All PK participants who received any dose of roflumilast. Results for roflumilast.
66131|NCT02165826|O2|Outcome|All PK Participants_Roflumilast N-oxide|All PK participants who received any dose of rofumilast. Results for roflumilast N-oxide.
66132|NCT02165826|O1|Outcome|All PK Participants_Roflumilast|All PK participants who received any dose of roflumilast. Results for roflumilast.
66133|NCT02165826|O2|Outcome|All PK Participants_Roflumilast N-oxide|All PK participants who received any dose of rofumilast. Results for roflumilast N-oxide.
66134|NCT02165826|O1|Outcome|All PK Participants_Roflumilast|All PK participants who received any dose of roflumilast. Results for roflumilast.
66135|NCT02165826|O3|Outcome|Roflumilast 500 μg OD_Down Titration Period|Participants in the roflumilast 500 μg once daily (OD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66136|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD_Down-Titration Period|Participants in the roflumilast 500 μg, every other day (EOD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66137|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD_Down Titration Period|Participants in the roflumilast 250 μg once daily (OD) then 500 μg OD who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66138|NCT02165826|O3|Outcome|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
66139|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD Then 500 μg OD|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66140|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66142|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD_Down-Titration Period|Participants in the roflumilast 500 μg, every other day (EOD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66143|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD_Down Titration Period|Participants in the roflumilast 250 μg once daily (OD) then 500 μg OD who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66144|NCT02165826|O3|Outcome|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
66145|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD Then 500 μg OD|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66146|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66147|NCT02165826|O3|Outcome|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
66148|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD Then 500 μg OD|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66149|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66150|NCT02165826|O3|Outcome|Roflumilast 500 μg OD_Down Titration Period|Participants in the roflumilast 500 μg once daily (OD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66151|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD_Down-Titration Period|Participants in the roflumilast 500 μg, every other day (EOD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66152|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD_Down Titration Period|Participants in the roflumilast 250 μg once daily (OD) then 500 μg OD who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66153|NCT02165826|O3|Outcome|Roflumilast 500 μg OD_Down Titration Period|Participants in the roflumilast 500 μg once daily (OD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66154|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD_Down-Titration Period|Participants in the roflumilast 500 μg, every other day (EOD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66155|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD_Down Titration Period|Participants in the roflumilast 250 μg once daily (OD) then 500 μg OD who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66156|NCT02165826|O3|Outcome|Roflumilast 500 μg OD_Down Titration Period|Participants in the roflumilast 500 μg once daily (OD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66157|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD_Down-Titration Period|Participants in the roflumilast 500 μg, every other day (EOD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66158|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD_Down Titration Period|Participants in the roflumilast 250 μg once daily (OD) then 500 μg OD who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66159|NCT02165826|O3|Outcome|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
66160|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD Then 500 μg OD|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66161|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66162|NCT02165826|O3|Outcome|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
66416|NCT02163915|O1|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
66163|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD Then 500 μg OD|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66164|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66165|NCT02165826|E6|Reported Event|Roflumilast 500 μg OD_Down Titration Period|Participants in the roflumilast 500 μg once daily (OD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66166|NCT02165826|E5|Reported Event|Roflumilast 500 μg EOD_Down-Titration Period|Participants in the roflumilast 500 μg, every other day (EOD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66167|NCT02165826|E4|Reported Event|Roflumilast 250 μg OD Then 500 μg OD_Down Titration Period|Participants in the roflumilast 250 μg once daily (OD) then 500 μg OD who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66168|NCT02165826|E3|Reported Event|Roflumilast 500 μg OD_Main Treatment Period|Roflumilast 500 μg tablets, orally, once daily for 12 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66169|NCT02165826|E2|Reported Event|Roflumilast 500 μg EOD Then 500 μg OD_Main Treatment Period|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66170|NCT02165826|E1|Reported Event|Roflumilast 250 μg OD Then 500 μg OD_Main Treatment Period|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
66171|NCT02165761|B3|Baseline|Total|Total of all reporting groups
66172|NCT02165761|B2|Baseline|Non-heparin Bonded Synthetic Graft|"Non-heparin bonded synthetic graft >~> Non-heparin bonded synthetic graft"
66173|NCT02165761|B1|Baseline|GORE® Hybrid Vascular Graft|"GORE® Hybrid Vascular Graft >~> GORE® Hybrid Vascular Graft"
66174|NCT02165761|P2|Participant Flow|Non-heparin Bonded Synthetic Graft|Subjects Randomized to the Non-heparin bonded synthetic graft
66175|NCT02165761|P1|Participant Flow|GORE® Hybrid Vascular Graft|Subjects Randomized to the GORE® Hybrid Vascular Graft
66176|NCT02165761|O2|Outcome|Non-heparin Bonded Synthetic Graft|"Non-heparin bonded synthetic graft >~> Non-heparin bonded synthetic graft"
66177|NCT02165761|O1|Outcome|GORE® Hybrid Vascular Graft|"GORE® Hybrid Vascular Graft >~> GORE® Hybrid Vascular Graft"
66178|NCT02165761|E2|Reported Event|Non-Heparin Synthetic Graft (Control)|Non-Heparin Synthetic Graft (Control)
66179|NCT02165761|E1|Reported Event|Hybrid Vascular Graft (Test)|Hybrid Vascular Graft (Test)
66180|NCT02165462|B1|Baseline|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
66181|NCT02165462|P1|Participant Flow|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
66182|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
66183|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
66184|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
66185|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
66186|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
66187|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
66417|NCT02163915|O5|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
66470|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
66188|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
66189|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
66190|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
66191|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
66192|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
66193|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
66194|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
66195|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
66196|NCT02165462|E1|Reported Event|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
66197|NCT02165111|B3|Baseline|Total|Total of all reporting groups
66198|NCT02165111|B2|Baseline|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
66199|NCT02165111|B1|Baseline|Onabotulinumtoxin A|"One hand of each patient was be randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
66200|NCT02165111|P2|Participant Flow|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each)."
66201|NCT02165111|P1|Participant Flow|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand."
66202|NCT02165111|O2|Outcome|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
66203|NCT02165111|O1|Outcome|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
66204|NCT02165111|O2|Outcome|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
66219|NCT02165072|O1|Outcome|Ultrasound of Acute Kidney Injury|This study represents a convenience sample of patients admitted to a medical intensive care unit with laboratory evidence of acute kidney injury. This is a prospective study. There is one study group only. There is no randomization.
66471|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
66205|NCT02165111|O1|Outcome|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
66206|NCT02165111|O2|Outcome|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
66207|NCT02165111|O1|Outcome|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
66208|NCT02165111|O2|Outcome|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
66209|NCT02165111|O1|Outcome|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
66210|NCT02165111|O2|Outcome|Placebo|"One hand of each patient were randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
66211|NCT02165111|O1|Outcome|Onabotulinumtoxin A|"One hand of each patient were randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
66212|NCT02165111|O2|Outcome|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
66213|NCT02165111|O1|Outcome|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
66214|NCT02165111|E2|Reported Event|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
66215|NCT02165111|E1|Reported Event|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
66216|NCT02165072|B1|Baseline|Ultrasound of Acute Kidney Injury|This study represents a convenience sample of patients admitted to a medical intensive care unit with laboratory evidence of acute kidney injury. This is a prospective study. There is one study group only. There is no randomization.
66217|NCT02165072|P1|Participant Flow|Ultrasound of Acute Kidney Injury|This study represents a convenience sample of patients admitted to a medical intensive care unit with laboratory evidence of acute kidney injury. This is a prospective study. There is one study group only. There is no randomization.
66218|NCT02165072|O1|Outcome|Ultrasound of Acute Kidney Injury|This study represents a convenience sample of patients admitted to a medical intensive care unit with laboratory evidence of acute kidney injury. This is a prospective study. There is one study group only. There is no randomization.
66418|NCT02163915|O4|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
66220|NCT02165072|E1|Reported Event|Ultrasound of Acute Kidney Injury|This study represents a convenience sample of patients admitted to a medical intensive care unit with laboratory evidence of acute kidney injury. This is a prospective study. There is one study group only. There is no randomization.
66221|NCT02164929|B5|Baseline|Total|Total of all reporting groups
66222|NCT02164929|B4|Baseline|No Block (PCA Alone)|"Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66223|NCT02164929|B3|Baseline|Epidural|"An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.~Epidural~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropi"
66224|NCT02164929|B2|Baseline|TAP Block|"Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~TAP block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66225|NCT02164929|B1|Baseline|Paravertebral Block|"Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).~Paravertebral block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66226|NCT02164929|P4|Participant Flow|No Block (PCA Alone)|"Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66227|NCT02164929|P3|Participant Flow|Epidural|"An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.~Epidural~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropi"
66228|NCT02164929|P2|Participant Flow|TAP Block|"Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~TAP block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66229|NCT02164929|P1|Participant Flow|Paravertebral Block|"Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).~Paravertebral block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66230|NCT02164929|O4|Outcome|No Block (PCA Alone)|"Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66231|NCT02164929|O3|Outcome|Epidural|"An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.~Epidural~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropi"
66232|NCT02164929|O2|Outcome|TAP Block|"Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~TAP block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66233|NCT02164929|O1|Outcome|Paravertebral Block|"Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).~Paravertebral block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66234|NCT02164929|O4|Outcome|No Block (PCA Alone)|"Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66235|NCT02164929|O3|Outcome|Epidural|"An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.~Epidural~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropi"
66236|NCT02164929|O2|Outcome|TAP Block|"Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~TAP block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66237|NCT02164929|O1|Outcome|Paravertebral Block|"Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).~Paravertebral block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66272|NCT02164916|B1|Baseline|Arm I (Cetuximab, Irinotecan Hydrochloride)|"Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over to Arm II.~cetuximab: Given IV~irinotecan hydrochloride: Given IV"
66472|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
66238|NCT02164929|O4|Outcome|No Block (PCA Alone)|"Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66239|NCT02164929|O3|Outcome|Epidural|"An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.~Epidural~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropi"
66240|NCT02164929|O2|Outcome|TAP Block|"Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~TAP block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66241|NCT02164929|O1|Outcome|Paravertebral Block|"Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).~Paravertebral block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66242|NCT02164929|O4|Outcome|No Block (PCA Alone)|"Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66243|NCT02164929|O3|Outcome|Epidural|"An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.~Epidural~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropi"
66244|NCT02164929|O2|Outcome|TAP Block|"Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~TAP block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66245|NCT02164929|O1|Outcome|Paravertebral Block|"Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).~Paravertebral block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66273|NCT02164916|P2|Participant Flow|Arm II (Cetuximab, Irinotecan Hydrochloride, Vemurafenib)|"Patients receive cetuximab and irinotecan hydrochloride as in Arm I and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~irinotecan hydrochloride: Given IV~vemurafenib: Given PO"
66473|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
66246|NCT02164929|O4|Outcome|No Block (PCA Alone)|"Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66247|NCT02164929|O3|Outcome|Epidural|"An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.~Epidural~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropi"
66248|NCT02164929|O2|Outcome|TAP Block|"Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~TAP block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66249|NCT02164929|O1|Outcome|Paravertebral Block|"Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).~Paravertebral block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66250|NCT02164929|O4|Outcome|No Block (PCA Alone)|"Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66251|NCT02164929|O3|Outcome|Epidural|"An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.~Epidural~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropi"
66252|NCT02164929|O2|Outcome|TAP Block|"Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~TAP block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66253|NCT02164929|O1|Outcome|Paravertebral Block|"Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).~Paravertebral block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66274|NCT02164916|P1|Participant Flow|Arm I (Cetuximab, Irinotecan Hydrochloride)|"Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over to Arm II.~cetuximab: Given IV~irinotecan hydrochloride: Given IV"
66474|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
66254|NCT02164929|O4|Outcome|No Block (PCA Alone)|"Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66255|NCT02164929|O3|Outcome|Epidural|"An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.~Epidural~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropi"
66256|NCT02164929|O2|Outcome|TAP Block|"Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~TAP block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66257|NCT02164929|O1|Outcome|Paravertebral Block|"Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).~Paravertebral block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66258|NCT02164929|O4|Outcome|No Block (PCA Alone)|"Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66259|NCT02164929|O3|Outcome|Epidural|"An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.~Epidural~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropi"
66260|NCT02164929|O2|Outcome|TAP Block|"Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~TAP block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66261|NCT02164929|O1|Outcome|Paravertebral Block|"Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).~Paravertebral block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66275|NCT02164916|O1|Outcome|Crossover: Vemurafenib + Cetuximab + Irinotecan|Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14, and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
66419|NCT02163915|O3|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
66262|NCT02164929|O4|Outcome|No Block (PCA Alone)|"Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66263|NCT02164929|O3|Outcome|Epidural|"An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.~Epidural~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropi"
66264|NCT02164929|O2|Outcome|TAP Block|"Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~TAP block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66265|NCT02164929|O1|Outcome|Paravertebral Block|"Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).~Paravertebral block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66266|NCT02164929|E4|Reported Event|No Block (PCA Alone)|"Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66267|NCT02164929|E3|Reported Event|Epidural|"An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.~Epidural~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropi"
66268|NCT02164929|E2|Reported Event|TAP Block|"Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~TAP block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66269|NCT02164929|E1|Reported Event|Paravertebral Block|"Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).~Paravertebral block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
66270|NCT02164916|B3|Baseline|Total|Total of all reporting groups
66271|NCT02164916|B2|Baseline|Arm II (Cetuximab, Irinotecan Hydrochloride, Vemurafenib)|"Patients receive cetuximab and irinotecan hydrochloride as in Arm I and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~irinotecan hydrochloride: Given IV~vemurafenib: Given PO"
66276|NCT02164916|O1|Outcome|Crossover: Vemurafenib + Cetuximab + Irinotecan|Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14, and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
66277|NCT02164916|O1|Outcome|Crossover: Vemurafenib + Cetuximab + Irinotecan|Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14, and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
66278|NCT02164916|O2|Outcome|Arm II (Cetuximab, Irinotecan Hydrochloride, Vemurafenib)|"Patients receive cetuximab and irinotecan hydrochloride as in Arm I and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~irinotecan hydrochloride: Given IV~vemurafenib: Given PO"
66279|NCT02164916|O1|Outcome|Arm I (Cetuximab, Irinotecan Hydrochloride)|"Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over to Arm II.~cetuximab: Given IV~irinotecan hydrochloride: Given IV"
66280|NCT02164916|O2|Outcome|Arm II (Cetuximab, Irinotecan Hydrochloride, Vemurafenib)|"Patients receive cetuximab and irinotecan hydrochloride as in Arm I and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~irinotecan hydrochloride: Given IV~vemurafenib: Given PO"
66281|NCT02164916|O1|Outcome|Arm I (Cetuximab, Irinotecan Hydrochloride)|"Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over to Arm II.~cetuximab: Given IV~irinotecan hydrochloride: Given IV"
66282|NCT02164916|O3|Outcome|Crossover: Vemurafenib + Cetuximab + Irinotecan|Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14, and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
66283|NCT02164916|O2|Outcome|Vemurafenib + Cetuximab + Irinotecan|Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14, and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
66284|NCT02164916|O1|Outcome|Cetuximab + Irinotecan|Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
66285|NCT02164916|O2|Outcome|Arm II (Cetuximab, Irinotecan Hydrochloride, Vemurafenib)|"Patients receive cetuximab and irinotecan hydrochloride as in Arm I and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~irinotecan hydrochloride: Given IV~vemurafenib: Given PO"
66286|NCT02164916|O1|Outcome|Arm I (Cetuximab, Irinotecan Hydrochloride)|"Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over to Arm II.~cetuximab: Given IV~irinotecan hydrochloride: Given IV"
66287|NCT02164916|E3|Reported Event|Crossover: Vemurafenib + Cetuximab + Irinotecan|Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14, and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
66288|NCT02164916|E2|Reported Event|Vemurafenib + Cetuximab + Irinotecan|Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14, and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
66289|NCT02164916|E1|Reported Event|Cetuximab + Irinotecan|Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
66290|NCT02164539|B7|Baseline|Total|Total of all reporting groups
66291|NCT02164539|B6|Baseline|FF/VI 100/25 µg|Participants received FF 100 µg in combination with VI 25 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66292|NCT02164539|B5|Baseline|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66293|NCT02164539|B4|Baseline|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66294|NCT02164539|B3|Baseline|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66295|NCT02164539|B2|Baseline|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with UMEC 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66296|NCT02164539|B1|Baseline|FF 100 µg|Participants received FF 100 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66297|NCT02164539|P7|Participant Flow|FF/UMEC/VI 100/250/25 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 250 µg and VI 25 µg once daily in the morning by inhalation using two separate DPIs (FF/UMEC 100/250 &amp;amp; VI 25) for 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66318|NCT02164539|O4|Outcome|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66298|NCT02164539|P6|Participant Flow|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66299|NCT02164539|P5|Participant Flow|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66300|NCT02164539|P4|Participant Flow|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66301|NCT02164539|P3|Participant Flow|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66302|NCT02164539|P2|Participant Flow|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66303|NCT02164539|P1|Participant Flow|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
66304|NCT02164539|O6|Outcome|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66305|NCT02164539|O5|Outcome|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66306|NCT02164539|O4|Outcome|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66307|NCT02164539|O3|Outcome|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66308|NCT02164539|O2|Outcome|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66309|NCT02164539|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
66310|NCT02164539|O6|Outcome|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66311|NCT02164539|O5|Outcome|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66312|NCT02164539|O4|Outcome|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66313|NCT02164539|O3|Outcome|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66314|NCT02164539|O2|Outcome|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66315|NCT02164539|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
66316|NCT02164539|O6|Outcome|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66317|NCT02164539|O5|Outcome|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66410|NCT02163915|O3|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
66319|NCT02164539|O3|Outcome|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66320|NCT02164539|O2|Outcome|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66321|NCT02164539|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
66322|NCT02164539|O6|Outcome|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66323|NCT02164539|O5|Outcome|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66324|NCT02164539|O4|Outcome|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66325|NCT02164539|O3|Outcome|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66326|NCT02164539|O2|Outcome|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66327|NCT02164539|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
66328|NCT02164539|O6|Outcome|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66329|NCT02164539|O5|Outcome|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66330|NCT02164539|O4|Outcome|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66331|NCT02164539|O3|Outcome|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66332|NCT02164539|O2|Outcome|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66333|NCT02164539|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
66334|NCT02164539|O6|Outcome|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66335|NCT02164539|O5|Outcome|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66336|NCT02164539|O4|Outcome|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66337|NCT02164539|O3|Outcome|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66338|NCT02164539|O2|Outcome|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66339|NCT02164539|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
66340|NCT02164539|E7|Reported Event|FF/UMEC/VI 100/250/25 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 250 µg and VI 25 µg once daily in the morning by inhalation using two separate DPIs (FF/UMEC 100/250 &amp;amp; VI 25) for 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66341|NCT02164539|E6|Reported Event|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66342|NCT02164539|E5|Reported Event|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66343|NCT02164539|E4|Reported Event|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66344|NCT02164539|E3|Reported Event|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66345|NCT02164539|E2|Reported Event|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
66346|NCT02164539|E1|Reported Event|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
66347|NCT02164396|B4|Baseline|Total|Total of all reporting groups
66348|NCT02164396|B3|Baseline|Senofilcon A or Narafilcon A|Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable).
66349|NCT02164396|B2|Baseline|Habitual Soft Contact Lens|Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation.
66350|NCT02164396|B1|Baseline|Spectacles|Consists of subjects that were randomized to wear spectacles throughout the duration of the study.
66351|NCT02164396|P3|Participant Flow|Senofilcon A or Narafilcon A|Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable).
66352|NCT02164396|P2|Participant Flow|Habitual Soft Contact Lens|Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation.
66353|NCT02164396|P1|Participant Flow|Spectacles|Consists of subjects that were randomized to wear spectacles throughout the duration of the study.
66354|NCT02164396|O3|Outcome|Senofilcon A or Narafilcon A|Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable).
66355|NCT02164396|O2|Outcome|Habitual Soft Contact Lens|Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation.
66356|NCT02164396|O1|Outcome|Spectacles|Consists of subjects that were randomized to wear spectacles throughout the duration of the study.
66357|NCT02164396|E3|Reported Event|Senofilcon A or Narafilcon A|Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable).
66358|NCT02164396|E2|Reported Event|Habitual Soft Contact Lens|Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation.
66359|NCT02164396|E1|Reported Event|Spectacles|Consists of subjects that were randomized to wear spectacles throughout the duration of the study.
66360|NCT02164318|B5|Baseline|Total|Total of all reporting groups
66361|NCT02164318|B4|Baseline|Combined Handgrip Training /Nitroglycerin Ointment Group|"Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Handgrip training~Nitroglycerin ointment"
66362|NCT02164318|B3|Baseline|Nitroglycerin Ointment Group|"Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Nitroglycerin ointment"
66363|NCT02164318|B2|Baseline|Handgrip Training Group|"Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes~Handgrip training"
66364|NCT02164318|B1|Baseline|Control Group|Standard of care
66411|NCT02163915|O2|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
66412|NCT02163915|O1|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
66365|NCT02164318|P4|Participant Flow|Combined Handgrip Training /Nitroglycerin Ointment Group|"Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Handgrip training~Nitroglycerin ointment"
66366|NCT02164318|P3|Participant Flow|Nitroglycerin Ointment Group|"Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Nitroglycerin ointment"
66367|NCT02164318|P2|Participant Flow|Handgrip Training Group|"Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes~Handgrip training"
66368|NCT02164318|P1|Participant Flow|Control Group|Standard of care
66369|NCT02164318|O4|Outcome|Combined Handgrip Training /Nitroglycerin Ointment Group|"Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Handgrip training~Nitroglycerin ointment"
66370|NCT02164318|O3|Outcome|Nitroglycerin Ointment Group|"Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Nitroglycerin ointment"
66371|NCT02164318|O2|Outcome|Handgrip Training Group|"Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes~Handgrip training"
66372|NCT02164318|O1|Outcome|Control Group|Standard of care
66373|NCT02164318|O4|Outcome|Combined Handgrip Training /Nitroglycerin Ointment Group|"Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Handgrip training~Nitroglycerin ointment"
66374|NCT02164318|O3|Outcome|Nitroglycerin Ointment Group|"Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Nitroglycerin ointment"
66375|NCT02164318|O2|Outcome|Handgrip Training Group|"Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes~Handgrip training"
66376|NCT02164318|O1|Outcome|Control Group|Standard of care
66377|NCT02164318|O4|Outcome|Combined Handgrip Training /Nitroglycerin Ointment Group|"Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Handgrip training~Nitroglycerin ointment"
66378|NCT02164318|O3|Outcome|Nitroglycerin Ointment Group|"Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Nitroglycerin ointment"
66379|NCT02164318|O2|Outcome|Handgrip Training Group|"Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes~Handgrip training"
66380|NCT02164318|O1|Outcome|Control Group|Standard of care
66381|NCT02164318|E4|Reported Event|Combined Handgrip Training /Nitroglycerin Ointment Group|"Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Handgrip training~Nitroglycerin ointment"
66382|NCT02164318|E3|Reported Event|Nitroglycerin Ointment Group|"Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Nitroglycerin ointment"
66383|NCT02164318|E2|Reported Event|Handgrip Training Group|"Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes~Handgrip training"
66384|NCT02164318|E1|Reported Event|Control Group|Standard of care
66385|NCT02163915|B6|Baseline|Total|Total of all reporting groups
66386|NCT02163915|B5|Baseline|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
66387|NCT02163915|B4|Baseline|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
66388|NCT02163915|B3|Baseline|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
66389|NCT02163915|B2|Baseline|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
66390|NCT02163915|B1|Baseline|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
66391|NCT02163915|P5|Participant Flow|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
66392|NCT02163915|P4|Participant Flow|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
66393|NCT02163915|P3|Participant Flow|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
66394|NCT02163915|P2|Participant Flow|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
66395|NCT02163915|P1|Participant Flow|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
66396|NCT02163915|O5|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
66397|NCT02163915|O4|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
66398|NCT02163915|O3|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
66399|NCT02163915|O2|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
66400|NCT02163915|O1|Outcome|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
66401|NCT02163915|O4|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
66402|NCT02163915|O3|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
66403|NCT02163915|O2|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
66404|NCT02163915|O1|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
66405|NCT02163915|O4|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
66406|NCT02163915|O3|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
66407|NCT02163915|O2|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
66408|NCT02163915|O1|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
66409|NCT02163915|O4|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
66420|NCT02163915|O2|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
66421|NCT02163915|O1|Outcome|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
66422|NCT02163915|O5|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
66423|NCT02163915|O4|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
66424|NCT02163915|O3|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
66425|NCT02163915|O2|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
66426|NCT02163915|O1|Outcome|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
66427|NCT02163915|O5|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
66428|NCT02163915|O4|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
66429|NCT02163915|O3|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
66430|NCT02163915|O2|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
66431|NCT02163915|O1|Outcome|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
66432|NCT02163915|O5|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
66433|NCT02163915|O4|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
66434|NCT02163915|O3|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
66435|NCT02163915|O2|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
66436|NCT02163915|O1|Outcome|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
66437|NCT02163915|O5|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
66438|NCT02163915|O4|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
66439|NCT02163915|O3|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
66440|NCT02163915|O2|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
66441|NCT02163915|O1|Outcome|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
66442|NCT02163915|E5|Reported Event|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
66443|NCT02163915|E4|Reported Event|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
66444|NCT02163915|E3|Reported Event|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
66445|NCT02163915|E2|Reported Event|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
66446|NCT02163915|E1|Reported Event|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
66447|NCT02163733|B3|Baseline|Total|Total of all reporting groups
66448|NCT02163733|B2|Baseline|Fasted/Fed|In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients who were randomised to the Fasted/Fed treatment group followed Sequence 2: AZD9291 tablets following a period of fasting in Period 1, then AZD9291 tablets following a high-fat meal in Period 2.
66449|NCT02163733|B1|Baseline|Fed/Fasted|In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients who were randomised to the Fed/Fasted treatment group followed Sequence 1: AZD9291 tablets following a high-fat meal in Period 1, then AZD9291 tablets following a period of fasting in Period 2.
66450|NCT02163733|P3|Participant Flow|AZD9291 Alone (Part B)|In Part B of the study, each patient (who completed Part A) received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation.
66451|NCT02163733|P2|Participant Flow|Fasted/Fed|In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients who were randomised to the Fasted/Fed treatment group followed Sequence 2: AZD9291 tablets following a period of fasting in Period 1, then AZD9291 tablets following a high-fat meal in Period 2.
66452|NCT02163733|P1|Participant Flow|Fed/Fasted|In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients who were randomised to the Fed/Fasted treatment group followed Sequence 1: AZD9291 tablets following a high-fat meal in Period 1, then AZD9291 tablets following a period of fasting in Period 2.
66453|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
66454|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
66455|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
66456|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
66457|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
66458|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
66459|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
66460|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
66461|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
66462|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
66463|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
66464|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
66465|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
66466|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
66467|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
66468|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
66475|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
66476|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
66477|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
66478|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
66479|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
66480|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
66481|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
66482|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
66483|NCT02163733|E3|Reported Event|Part B Safety Population|In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation.
66484|NCT02163733|E2|Reported Event|Part A Safety Population|In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients were randomised to either Sequence 1 (AZD9291 tablets following a high-fat meal in Period 1, then AZD9291 tablets following a period of fasting in Period 2) or Sequence 2 (AZD9291 tablets following a period of fasting in Period 1, then AZD9291 tablets following a high-fat meal in Period 2).
66485|NCT02163733|E1|Reported Event|Overall Safety Population|Parts A and B of the study combined.
66486|NCT02163538|B3|Baseline|Total|Total of all reporting groups
66487|NCT02163538|B2|Baseline|Ligasure Device|"This group of women undergoing hysterectomy is randomized to the Ligasure energy device.~Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy."
66488|NCT02163538|B1|Baseline|Articulating Enseal|"This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.~articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy."
66489|NCT02163538|P2|Participant Flow|Ligasure Device|"This group of women undergoing hysterectomy is randomized to the Ligasure energy device.~Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy."
66490|NCT02163538|P1|Participant Flow|Articulating Enseal|"This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.~articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy."
66491|NCT02163538|O2|Outcome|Ligasure Device|"This group of women undergoing hysterectomy is randomized to the Ligasure energy device.~Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy."
66492|NCT02163538|O1|Outcome|Articulating Enseal|"This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.~articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy."
66493|NCT02163538|O2|Outcome|Ligasure Device|"This group of women undergoing hysterectomy is randomized to the Ligasure energy device.~Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy."
66494|NCT02163538|O1|Outcome|Articulating Enseal|"This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.~articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy."
66495|NCT02163538|O2|Outcome|Ligasure Device|"This group of women undergoing hysterectomy is randomized to the Ligasure energy device.~Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy."
66496|NCT02163538|O1|Outcome|Articulating Enseal|"This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.~articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy."
66497|NCT02163538|O2|Outcome|Ligasure Device|"This group of women undergoing hysterectomy is randomized to the Ligasure energy device.~Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy."
66498|NCT02163538|O1|Outcome|Articulating Enseal|"This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.~articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy."
66499|NCT02163538|O2|Outcome|Ligasure Device|"This group of women undergoing hysterectomy is randomized to the Ligasure energy device.~Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy."
66500|NCT02163538|O1|Outcome|Articulating Enseal|"This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.~articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy."
66501|NCT02163538|O2|Outcome|Ligasure Device|"This group of women undergoing hysterectomy is randomized to the Ligasure energy device.~Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy."
66502|NCT02163538|O1|Outcome|Articulating Enseal|"This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.~articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy."
66503|NCT02163538|E2|Reported Event|Ligasure Device|"This group of women undergoing hysterectomy is randomized to the Ligasure energy device.~Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy."
66504|NCT02163538|E1|Reported Event|Articulating Enseal|"This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.~articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy."
66505|NCT02163421|B5|Baseline|Total|Total of all reporting groups
66506|NCT02163421|B4|Baseline|Vedolizumab Subcutaneous 160 mg|Vedolizumab 160 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
66507|NCT02163421|B3|Baseline|Vedolizumab Subcutaneous 108 mg|Vedolizumab 108 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
66508|NCT02163421|B2|Baseline|Vedolizumab Subcutaneous 54 mg|Vedolizumab 54 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
66509|NCT02163421|B1|Baseline|Vedolizumab Intravenous 300 mg|Vedolizumab 300 mg, 30-minutes infusion, intravenously once only on Day 1 in a treatment period of 168 days.
66510|NCT02163421|P4|Participant Flow|Vedolizumab Subcutaneous 160 mg|Vedolizumab 160 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
66511|NCT02163421|P3|Participant Flow|Vedolizumab Subcutaneous 108 mg|Vedolizumab 108 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
66512|NCT02163421|P2|Participant Flow|Vedolizumab Subcutaneous 54 mg|Vedolizumab 54 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
66513|NCT02163421|P1|Participant Flow|Vedolizumab Intravenous 300 mg|Vedolizumab 300 mg, 30-minutes infusion, intravenously once only on Day 1 in a treatment period of 168 days.
66514|NCT02163421|O1|Outcome|Vedolizumab Subcutaneous|Vedolizumab 54 mg or 108 mg or 160 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
66515|NCT02163421|E4|Reported Event|Vedolizumab Subcutaneous 160 mg|Vedolizumab 160 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
66516|NCT02163421|E3|Reported Event|Vedolizumab Subcutaneous 108 mg|Vedolizumab 108 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
66517|NCT02163421|E2|Reported Event|Vedolizumab Subcutaneous 54 mg|Vedolizumab 54 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
66518|NCT02163421|E1|Reported Event|Vedolizumab Intravenous 300 mg|Vedolizumab 300 mg, 30-minutes infusion, intravenously once only on Day 1 in a treatment period of 168 days.
66519|NCT02163395|B1|Baseline|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm~FullCeram implant: FullCeram implantation"
66520|NCT02163395|P1|Participant Flow|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm~FullCeram implant: FullCeram implantation"
66521|NCT02163395|O1|Outcome|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm~FullCeram implant: FullCeram implantation"
66522|NCT02163395|O1|Outcome|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm~FullCeram implant: FullCeram implantation"
66523|NCT02163395|O1|Outcome|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm~FullCeram implant: FullCeram implantation"
66524|NCT02163395|O1|Outcome|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm~FullCeram implant: FullCeram implantation"
66525|NCT02163395|E1|Reported Event|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm~FullCeram implant: FullCeram implantation"
66526|NCT02163187|B3|Baseline|Total|Total of all reporting groups
66527|NCT02163187|B2|Baseline|InterStimTM the Device Off, Then InterStim the Device on|"The device will be on but will not stimulate for 4 weeks, then off for two weeks, and then the device will be set to stimulate for 4 weeks.~No participants were accrued to this arm before the study was closed."
66528|NCT02163187|B1|Baseline|InterStimTM the Device on, Then InterStim TM the Device Off|The device will be set to stimulate for 4 weeks, then off for two weeks, and then the device will be on but will not stimulate for 4 weeks.
66529|NCT02163187|P2|Participant Flow|InterStimTM the Device Off, Then InterStimTM Device on|"The device will be on but will not stimulate for 4 weeks, then off for two weeks, and then the device will be set to stimulate for 4 weeks.~Implantation of the InterStimTM~MSK BFI questionnaires~The Low Anterior Resection Score (LARS) questionnaires~The EuroQOL5D questionnaires~The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires"
66530|NCT02163187|P1|Participant Flow|InterStimTM the Device on, Then InterStimTM Device Off|"The device will be set to stimulate for 4 weeks, then off for two weeks, and then the device will be on but will not stimulate for 4 weeks.~Implantation of the InterStimTM~MSK BFI questionnaires~The Low Anterior Resection Score (LARS) questionnaires~The EuroQOL5D questionnaires~The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires"
66531|NCT02163187|O2|Outcome|InterStimTM the Device Off|"The device will be on but will not stimulate for 4 weeks, then off for two weeks, and then the device will be set to stimulate for 4 weeks.~Implantation of the InterStimTM~MSK BFI questionnaires~The Low Anterior Resection Score (LARS) questionnaires~The EuroQOL5D questionnaires~The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires"
66532|NCT02163187|O1|Outcome|InterStimTM the Device on|"The device will be set to stimulate for 4 weeks, then off for two weeks, and then the device will be on but will not stimulate for 4 weeks.~Implantation of the InterStimTM~MSK BFI questionnaires~The Low Anterior Resection Score (LARS) questionnaires~The EuroQOL5D questionnaires~The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires"
66533|NCT02163187|O2|Outcome|InterStimTM the Device Off|"The device will be on but will not stimulate for 4 weeks, then off for two weeks, and then the device will be set to stimulate for 4 weeks.~Implantation of the InterStimTM~MSK BFI questionnaires~The Low Anterior Resection Score (LARS) questionnaires~The EuroQOL5D questionnaires~The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires"
66534|NCT02163187|O1|Outcome|InterStimTM the Device on|"The device will be set to stimulate for 4 weeks, then off for two weeks, and then the device will be on but will not stimulate for 4 weeks.~Implantation of the InterStimTM~MSK BFI questionnaires~The Low Anterior Resection Score (LARS) questionnaires~The EuroQOL5D questionnaires~The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires"
66535|NCT02163187|E2|Reported Event|InterStimTM the Device Off|"The device will be on but will not stimulate for 4 weeks, then off for two weeks, and then the device will be set to stimulate for 4 weeks.~Implantation of the InterStimTM~MSK BFI questionnaires~The Low Anterior Resection Score (LARS) questionnaires~The EuroQOL5D questionnaires~The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires"
66536|NCT02163187|E1|Reported Event|InterStimTM the Device on|"The device will be set to stimulate for 4 weeks, then off for two weeks, and then the device will be on but will not stimulate for 4 weeks.~Implantation of the InterStimTM~MSK BFI questionnaires~The Low Anterior Resection Score (LARS) questionnaires~The EuroQOL5D questionnaires~The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires"
66537|NCT02162979|B3|Baseline|Total|Total of all reporting groups
66538|NCT02162979|B2|Baseline|Placebo Comparator|"subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~Placebo"
66539|NCT02162979|B1|Baseline|Viagra|"subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~sildenafil: sildenafil 50mg BID for 2 weeks"
66983|NCT02159040|E1|Reported Event|Azacitidine|75mg/m2 7days/28 day cycle
66540|NCT02162979|P2|Participant Flow|Placebo Comparator|"subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~Placebo"
66541|NCT02162979|P1|Participant Flow|Viagra|"subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~sildenafil: sildenafil 50mg BID for 2 weeks"
66542|NCT02162979|O2|Outcome|Placebo Comparator|"subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~Placebo"
66543|NCT02162979|O1|Outcome|Viagra|"subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~sildenafil: sildenafil 50mg BID for 2 weeks"
66544|NCT02162979|O2|Outcome|Placebo Comparator|"subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~Placebo"
66545|NCT02162979|O1|Outcome|Viagra|"subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~sildenafil: sildenafil 50mg BID for 2 weeks"
66546|NCT02162979|O2|Outcome|Placebo Comparator|"subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~Placebo"
66547|NCT02162979|O1|Outcome|Viagra|"subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~sildenafil: sildenafil 50mg BID for 2 weeks"
66548|NCT02162979|E2|Reported Event|Placebo Comparator|"subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~Placebo"
66549|NCT02162979|E1|Reported Event|Viagra|"subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~sildenafil: sildenafil 50mg BID for 2 weeks"
66550|NCT02162862|B4|Baseline|Total|Total of all reporting groups
66551|NCT02162862|B3|Baseline|Behavioral Counseling + Bupropion|Brief Behavioral Therapy for Sleep Disruption in IBD (BBTS-I) plus bupropion-SR (bupropion-Sustained Release). 8-week trial of bupropion-SR (target dose: 200-300 mg/day). bup-SR, a noradrenergic dopaminergic reuptake inhibitor (NDRI). NDRI has been shown to improve fatigue and rapid eye movement-sleep (REM) in medically ill populations.
66552|NCT02162862|B2|Baseline|Control Group|Individuals free of physical and psychiatric illness.
66553|NCT02162862|B1|Baseline|Behavioral Counseling|"Brief Behavioral Therapy for Sleep Disruption in IBD (BBTS-I). This treatment phase focuses on treating insomnia, a nighttime component of sleep disturbance delivered in 1:1 sessions which can be completed in person or by phone, except for initial session.~Behavioral Counseling"
66554|NCT02162862|P3|Participant Flow|Behavioral Counseling + Bupropion|Brief Behavioral Therapy for Sleep Disruption in IBD (BBTS-I) plus bupropion-SR (bupropion-Sustained Release). 8 -week trial of bupropion-SR (target dose: 200-300mg/day). Bupropion-SR, a noradrenergic dopaminergic reuptake inhibitor (NDRI). NDRI has been shown to improve fatigue and rapid eye movement sleep (REM) in medically ill populations.
66555|NCT02162862|P2|Participant Flow|Behavioral Counseling|"Brief Behavioral Therapy for Sleep Disruption in IBD (BBTS-I). This treatment phase focuses on treating insomnia, a nighttime component of sleep disturbance delivered in 1:1 sessions which can be completed in person or by phone, except for initial session.~Behavioral Counseling~Within this arm, some participants offered bupropion-SR (bupropion-Sustained Release). 8-week trial of bupropion-SR (target dose: 200-300 mg/day). bup-SR, a noradrenergic dopaminergic reuptake inhibitor (NDRI). NDRI has been shown to improve fatigue and rapid eye movement-sleep (REM) in medically ill populations.~bupropion-SR"
66556|NCT02162862|P1|Participant Flow|Healthy Control|The healthy control group included individuals who were free of physical and psychiatric illness between the ages of 15-30.
66557|NCT02162862|O3|Outcome|Behavioral Counseling + Bupropion|"Within this arm, some participants offered bupropion-SR (bupropion-Sustained Release). 8-week trial of bupropion-SR (target dose: 200-300 mg/day). bup-SR, a noradrenergic dopaminergic reuptake inhibitor (NDRI). NDRI has been shown to improve fatigue and rapid eye movement-sleep (REM) in medically ill populations.~bupropion-SR"
66558|NCT02162862|O2|Outcome|Healthy Control|The healthy control group included individuals who were free of physical and psychiatric illness between the ages of 15-30.
66559|NCT02162862|O1|Outcome|Behavioral Counseling|"Brief Behavioral Therapy for Sleep Disruption in IBD (BBTS-I). This treatment phase focuses on treating insomnia, a nighttime component of sleep disturbance delivered in 1:1 sessions which can be completed in person or by phone, except for initial session.~Behavioral Counseling"
66560|NCT02162862|O3|Outcome|Behavioral Counseling + Bupropion|"8-week trial of bupropion-SR (target dose: 200-300 mg/day). bup-SR, a noradrenergic dopaminergic reuptake inhibitor (NDRI). NDRI has been shown to improve fatigue and rapid eye movement-sleep (REM) in medically ill populations.~bupropion-SR"
66561|NCT02162862|O2|Outcome|Healthy Control|The healthy control group included individuals who were free of physical and psychiatric illness between the ages of 15-30.
66562|NCT02162862|O1|Outcome|Behavioral Counseling|"Brief Behavioral Therapy for Sleep Disruption in IBD (BBTS-I). This treatment phase focuses on treating insomnia, a nighttime component of sleep disturbance delivered in 1:1 sessions which can be completed in person or by phone, except for initial session.~Behavioral Counseling~Within this arm, some participants offered bupropion-SR (bupropion-Sustained Release). 8-week trial of bupropion-SR (target dose: 200-300 mg/day). bup-SR, a noradrenergic dopaminergic reuptake inhibitor (NDRI). NDRI has been shown to improve fatigue and rapid eye movement-sleep (REM) in medically ill populations.~bupropion-SR"
66563|NCT02162862|E3|Reported Event|Behavioral Counseling + Bupropion|Participants offered bupropion-SR (bupropion-Sustained Release). 8-week trial of bupropion-SR (target dose: 200-300 mg/day). Bup-SR, a noradrenergic dopaminergic reuptake inhibitor (NDRI). NDRI has been shown to improve fatigue and rapid eye movement-sleep (REM) in medically ill populations.
66564|NCT02162862|E2|Reported Event|Behavioral Counseling|"Brief Behavioral Therapy for Sleep Disruption in IBD (BBTS-I). This treatment phase focuses on treating insomnia, a nighttime component of sleep disturbance delivered in 1:1 sessions which can be completed in person or by phone, except for initial session.~Behavioral Counseling"
66565|NCT02162862|E1|Reported Event|Healthy Control|The healthy control group included individuals who were free of physical and psychiatric illness between the ages of 15-30.
66566|NCT02162758|B3|Baseline|Total|Total of all reporting groups
66567|NCT02162758|B2|Baseline|Dexlansoprazole 60 mg BID|Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
66568|NCT02162758|B1|Baseline|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
66569|NCT02162758|P2|Participant Flow|Dexlansoprazole 60 mg BID|Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
66570|NCT02162758|P1|Participant Flow|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
66571|NCT02162758|O2|Outcome|Dexlansoprazole 60 mg BID|Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
66572|NCT02162758|O1|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
66573|NCT02162758|O2|Outcome|Dexlansoprazole 60 mg BID|Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
66574|NCT02162758|O1|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
66575|NCT02162758|O2|Outcome|Dexlansoprazole 60 mg BID|Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
66576|NCT02162758|O1|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
66577|NCT02162758|O2|Outcome|Dexlansoprazole 60 mg BID|Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
66578|NCT02162758|O1|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
66579|NCT02162758|E2|Reported Event|Dexlansoprazole 60 mg BID|Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
66580|NCT02162758|E1|Reported Event|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
66581|NCT02162680|B4|Baseline|Total|Total of all reporting groups
66582|NCT02162680|B3|Baseline|Bacteriostatic Normal Saline (BNS)|"bacteriostatic normal saline (BNS) injection~bacteriostatic normal saline (BNS)"
66583|NCT02162680|B2|Baseline|Lidocaine|"1% lidocaine intradermal injection~1% lidocaine"
66584|NCT02162680|B1|Baseline|no Local Anesthetic|usual care practice of no local anesthetic administration
66585|NCT02162680|P3|Participant Flow|Bacteriostatic Normal Saline (BNS)|"bacteriostatic normal saline (BNS) injection~bacteriostatic normal saline (BNS)"
66586|NCT02162680|P2|Participant Flow|Lidocaine|"1% lidocaine intradermal injection~1% lidocaine"
66587|NCT02162680|P1|Participant Flow|no Local Anesthetic|usual care practice of no local anesthetic administration
66588|NCT02162680|O3|Outcome|Bacteriostatic Normal Saline (BNS)|"bacteriostatic normal saline (BNS) injection~bacteriostatic normal saline (BNS)"
66589|NCT02162680|O2|Outcome|Lidocaine|"1% lidocaine intradermal injection~1% lidocaine"
66590|NCT02162680|O1|Outcome|no Local Anesthetic|usual care practice of no local anesthetic administration
66591|NCT02162680|E3|Reported Event|Bacteriostatic Normal Saline (BNS)|"bacteriostatic normal saline (BNS) injection~bacteriostatic normal saline (BNS)"
66592|NCT02162680|E2|Reported Event|Lidocaine|"1% lidocaine intradermal injection~1% lidocaine"
66593|NCT02162680|E1|Reported Event|no Local Anesthetic|usual care practice of no local anesthetic administration
66594|NCT02162576|B1|Baseline|Propeller Health Intervention Group|All participants attached the Propeller sensor to their SABA medications and tracked the time and location of use for up to 13 months, to capture seasonal variation in medication use, symptoms and environmental triggers. The first 30-day run-in period served as a control period to assess levels of asthma control and SABA use; subject actuations were tracked, but participants and physicians did not receive their data or feedback. After the run-in period, participants received the full intervention for 12 months (see intervention for description).
66595|NCT02162576|P1|Participant Flow|Propeller Health Intervention Group|"All participants attached the Propeller sensor to their SABA medications and tracked the time and location of use for up to 13 months, to capture seasonal variation in medication use, symptoms and environmental triggers. The first 30-day run-in period served as a control period to assess levels of asthma control and SABA use; subject actuations were tracked, but participants and physicians did not receive their data or feedback. After the run-in period, participants received the full intervention for 12 months.~The Propeller sensor passively records inhaler actuations with a time stamp and location. Actuation data are then securely transmitted to Propeller Health where the information is also compiled into individual reports via multiple platforms, providing an assessment of their management based on the national guidelines, together with personalized information to help encourage and support self-management (see intervention description for full details)."
66596|NCT02162576|O1|Outcome|Propeller Health Intervention|"All participants attached the Propeller sensor to their SABA medications and tracked the time and location of use for up to 13 months, to capture seasonal variation in medication use, symptoms and environmental triggers. The first 30-day run-in period served as a control period to assess levels of asthma control and SABA use; subject actuations were tracked, but participants and physicians did not receive their data or feedback. After the run-in period, participants received the full intervention for 12 months.~The Propeller sensor passively records inhaler actuations with a time stamp and location. Actuation data are then securely transmitted to Propeller Health where the information is also compiled into individual reports via multiple platforms, providing an assessment of their management based on the national guidelines, together with personalized information to help encourage and support self-management (see intervention description for full details)."
66622|NCT02161757|O2|Outcome|Tralo 300 mg Q4W|Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses).
66623|NCT02161757|O1|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
66624|NCT02161757|O3|Outcome|Placebo|Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort.
66625|NCT02161757|O2|Outcome|Tralo 300 mg Q4W|Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses).
66984|NCT02158975|B1|Baseline|MLN9708|"MLN9708 4mg by mouth weekly (days 1, 8, 15) every 28 days.~MLN9708"
66597|NCT02162576|O1|Outcome|Propeller Health Intervention|"All participants attached the Propeller sensor to their SABA medications and tracked the time and location of use for up to 13 months, to capture seasonal variation in medication use, symptoms and environmental triggers. The first 30-day run-in period served as a control period to assess levels of asthma control and SABA use; subject actuations were tracked, but participants and physicians did not receive their data or feedback. After the run-in period, participants received the full intervention for 12 months.~The Propeller sensor passively records inhaler actuations with a time stamp and location. Actuation data are then securely transmitted to Propeller Health where the information is also compiled into individual reports via multiple platforms, providing an assessment of their management based on the national guidelines, together with personalized information to help encourage and support self-management (see intervention description for full details)."
66598|NCT02162576|O1|Outcome|Propeller Health Intervention Group|"All participants attached the Propeller sensor to their SABA medications and tracked the time and location of use for up to 13 months, to capture seasonal variation in medication use, symptoms and environmental triggers. The first 30-day run-in period served as a control period to assess levels of asthma control and SABA use; subject actuations were tracked, but participants and physicians did not receive their data or feedback. After the run-in period, participants received the full intervention for 12 months.~The Propeller sensor passively records inhaler actuations with a time stamp and location. Actuation data are then securely transmitted to Propeller Health where the information is also compiled into individual reports via multiple platforms, providing an assessment of their management based on the national guidelines, together with personalized information to help encourage and support self-management (see intervention description for full details)."
66599|NCT02162576|E1|Reported Event|Propeller Health Intervention|"After the control period is completed at 1 month, all participants will continue using their sensors, and will begin to receive the full intervention for 12 months. The intervention includes access to all of the participant's sensor-collected data, trends, educational information and weekly reports. The 13-month term was chosen in order to eliminate any seasonal variation in asthma exacerbations.~Propeller Health: The digital sensor records rescue inhaler actuations, as well as time and date stamp, and location if available. Actuation data are then securely transmitted to Propeller Health where events and an assessment of asthma control can be viewed in secure online interfaces. The information is also compiled into individual reports via mobile apps, online dashboards, email reports and text message reminders that are returned to the patient. Each participant was invited to share reports with his or her healthcare provider, but this was not required."
66600|NCT02161757|B4|Baseline|Total|Total of all reporting groups
66601|NCT02161757|B3|Baseline|Placebo|Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort.
66602|NCT02161757|B2|Baseline|Tralo 300 mg Q4W|Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses).
66603|NCT02161757|B1|Baseline|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
66604|NCT02161757|P3|Participant Flow|Placebo|Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort.
66605|NCT02161757|P2|Participant Flow|Tralo 300 mg Q4W|Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses).
66606|NCT02161757|P1|Participant Flow|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
66607|NCT02161757|O2|Outcome|Tralo 300 mg Q4W|Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses).
66608|NCT02161757|O1|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
66609|NCT02161757|O3|Outcome|Placebo|Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort.
66610|NCT02161757|O2|Outcome|Tralo 300 mg Q4W|Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses).
66611|NCT02161757|O1|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
66612|NCT02161757|O3|Outcome|Placebo|Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort.
66613|NCT02161757|O2|Outcome|Tralo 300 mg Q4W|Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses).
66614|NCT02161757|O1|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
66615|NCT02161757|O3|Outcome|Placebo|Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort.
66616|NCT02161757|O2|Outcome|Tralo 300 mg Q4W|Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses).
66617|NCT02161757|O1|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
66618|NCT02161757|O3|Outcome|Placebo|Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort.
66619|NCT02161757|O2|Outcome|Tralo 300 mg Q4W|Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses).
66620|NCT02161757|O1|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
66621|NCT02161757|O3|Outcome|Placebo|Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort.
66626|NCT02161757|O1|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
66627|NCT02161757|O3|Outcome|Placebo|Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort.
66628|NCT02161757|O2|Outcome|Tralo 300 mg Q4W|Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses).
66629|NCT02161757|O1|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
66630|NCT02161757|O3|Outcome|Placebo|Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort.
66631|NCT02161757|O2|Outcome|Tralo 300 mg Q4W|Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses).
66632|NCT02161757|O1|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
66633|NCT02161757|O3|Outcome|Placebo|Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort.
66634|NCT02161757|O2|Outcome|Tralo 300 mg Q4W|Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses).
66635|NCT02161757|O1|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
66636|NCT02161757|O3|Outcome|Placebo|Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort.
66637|NCT02161757|O2|Outcome|Tralo 300 mg Q4W|Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses).
66638|NCT02161757|O1|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
66639|NCT02161757|O3|Outcome|Placebo|Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort.
66640|NCT02161757|O2|Outcome|Tralo 300 mg Q4W|Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses).
66641|NCT02161757|O1|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
66642|NCT02161757|O3|Outcome|Placebo|Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort.
66643|NCT02161757|O2|Outcome|Tralo 300 mg Q4W|Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses).
66644|NCT02161757|O1|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
66645|NCT02161757|O3|Outcome|Placebo|Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort.
66646|NCT02161757|O2|Outcome|Tralo 300 mg Q4W|Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses).
66647|NCT02161757|O1|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
66648|NCT02161757|O3|Outcome|Placebo|Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort.
66649|NCT02161757|O2|Outcome|Tralo 300 mg Q4W|Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses).
66650|NCT02161757|O1|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
66651|NCT02161757|O3|Outcome|Placebo|Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort.
66652|NCT02161757|O2|Outcome|Tralo 300 mg Q4W|Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses).
66653|NCT02161757|O1|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
66654|NCT02161757|O3|Outcome|Placebo|Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort.
66655|NCT02161757|O2|Outcome|Tralo 300 mg Q4W|Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses).
66656|NCT02161757|O1|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
66657|NCT02161757|E3|Reported Event|Placebo|Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort.
66658|NCT02161757|E2|Reported Event|Tralo 300 mg Q4W|Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses).
66659|NCT02161757|E1|Reported Event|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
66660|NCT02161549|B3|Baseline|Total|Total of all reporting groups
66661|NCT02161549|B2|Baseline|Colonoscopy With MotusGi CleanUp System Rev 1.5|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0~Motus Gl CleanUp System"
66662|NCT02161549|B1|Baseline|Colonoscopy With MotusGi CleanUp System Rev 1.0|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0~Motus Gl CleanUp System"
66663|NCT02161549|P2|Participant Flow|Colonoscopy With MotusGi CleanUp System Rev 1.5|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0~Motus Gl CleanUp System"
66664|NCT02161549|P1|Participant Flow|Colonoscopy With MotusGi CleanUp System Rev 1.0|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0~Motus Gl CleanUp System"
66665|NCT02161549|O2|Outcome|Colonoscopy With MotusGi CleanUp System Rev 1.5|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0~Motus Gl CleanUp System"
66666|NCT02161549|O1|Outcome|Colonoscopy With MotusGi CleanUp System Rev 1.0|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0~Motus Gl CleanUp System"
66667|NCT02161549|E2|Reported Event|Colonoscopy With MotusGi CleanUp System Rev 1.5|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0~Motus Gl CleanUp System"
66668|NCT02161549|E1|Reported Event|Colonoscopy With MotusGi CleanUp System Rev 1.0|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0~Motus Gl CleanUp System"
66669|NCT02161484|B3|Baseline|Total|Total of all reporting groups
66670|NCT02161484|B2|Baseline|Lumbar Plexus Nerve Block|"Arm: Active Comparator: Lumbar Plexus Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~No sham/placebo parasacral (sciatic) blocks will be performed in this group."
66671|NCT02161484|B1|Baseline|Continuous Lumbar Plexus Block With Parasacral Nerve Block|"Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected."
66672|NCT02161484|P2|Participant Flow|Lumbar Plexus Nerve Block|"Arm: Active Comparator: Lumbar Plexus Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~No sham/placebo parasacral (sciatic) blocks will be performed in this group."
66673|NCT02161484|P1|Participant Flow|Continuous Lumbar Plexus Block With Parasacral Nerve Block|"Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected."
66674|NCT02161484|O2|Outcome|Lumbar Plexus Nerve Block|"Arm: Active Comparator: Lumbar Plexus Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~No sham/placebo parasacral (sciatic) blocks will be performed in this group."
66675|NCT02161484|O1|Outcome|Continuous Lumbar Plexus Block With Parasacral Nerve Block|"Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected."
66676|NCT02161484|O2|Outcome|Lumbar Plexus Nerve Block|"Arm: Active Comparator: Lumbar Plexus Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~No sham/placebo parasacral (sciatic) blocks will be performed in this group."
66711|NCT02161146|E5|Reported Event|AGN-229666/Vehicle|One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.
66712|NCT02161146|E4|Reported Event|AGN-229666/Olopatadine|One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.
66713|NCT02161146|E3|Reported Event|Olopatadine|One drop of olopatadine in each eye on Days 1 and 15.
66714|NCT02161146|E2|Reported Event|Vehicle|One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.
66715|NCT02161146|E1|Reported Event|AGN-229666|One drop of AGN-229666 in each eye on Days 1 and 15.
66677|NCT02161484|O1|Outcome|Continuous Lumbar Plexus Block With Parasacral Nerve Block|"Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected."
66678|NCT02161484|O2|Outcome|Lumbar Plexus Nerve Block|"Arm: Active Comparator: Lumbar Plexus Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~No sham/placebo parasacral (sciatic) blocks will be performed in this group."
66679|NCT02161484|O1|Outcome|Continuous Lumbar Plexus Block With Parasacral Nerve Block|"Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected."
66680|NCT02161484|O2|Outcome|Lumbar Plexus Nerve Block|"Arm: Active Comparator: Lumbar Plexus Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~No sham/placebo parasacral (sciatic) blocks will be performed in this group."
66681|NCT02161484|O1|Outcome|Continuous Lumbar Plexus Block With Parasacral Nerve Block|"Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected."
66682|NCT02161484|O2|Outcome|Lumbar Plexus Nerve Block|"Arm: Active Comparator: Lumbar Plexus Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~No sham/placebo parasacral (sciatic) blocks will be performed in this group."
66683|NCT02161484|O1|Outcome|Continuous Lumbar Plexus Block With Parasacral Nerve Block|"Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected."
66684|NCT02161484|O2|Outcome|Lumbar Plexus Nerve Block|"Arm: Active Comparator: Lumbar Plexus Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~No sham/placebo parasacral (sciatic) blocks will be performed in this group."
66685|NCT02161484|O1|Outcome|Continuous Lumbar Plexus Block With Parasacral Nerve Block|"Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected."
66686|NCT02161484|O2|Outcome|Lumbar Plexus Nerve Block|"Arm: Active Comparator: Lumbar Plexus Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~No sham/placebo parasacral (sciatic) blocks will be performed in this group."
66809|NCT02160002|O2|Outcome|Higher Weight (1800 Grams)|Weaning from an incubator at a higher weight (1800 grams)
66687|NCT02161484|O1|Outcome|Continuous Lumbar Plexus Block With Parasacral Nerve Block|"Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected."
66688|NCT02161484|O2|Outcome|Lumbar Plexus Nerve Block|"Arm: Active Comparator: Lumbar Plexus Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~No sham/placebo parasacral (sciatic) blocks will be performed in this group."
66689|NCT02161484|O1|Outcome|Continuous Lumbar Plexus Block With Parasacral Nerve Block|"Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected."
66690|NCT02161484|O2|Outcome|Lumbar Plexus Nerve Block|"Arm: Active Comparator: Lumbar Plexus Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~No sham/placebo parasacral (sciatic) blocks will be performed in this group."
66691|NCT02161484|O1|Outcome|Continuous Lumbar Plexus Block With Parasacral Nerve Block|"Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected."
66692|NCT02161484|E2|Reported Event|Lumbar Plexus Nerve Block|"Arm: Active Comparator: Lumbar Plexus Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~No sham/placebo parasacral (sciatic) blocks will be performed in this group."
66693|NCT02161484|E1|Reported Event|Continuous Lumbar Plexus Block With Parasacral Nerve Block|"Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected."
66694|NCT02161146|B6|Baseline|Total|Total of all reporting groups
66695|NCT02161146|B5|Baseline|AGN-229666/Vehicle|One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.
66696|NCT02161146|B4|Baseline|AGN-229666/Olopatadine|One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.
66697|NCT02161146|B3|Baseline|Olopatadine|One drop of olopatadine in each eye on Days 1 and 15.
66698|NCT02161146|B2|Baseline|Vehicle|One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.
66699|NCT02161146|B1|Baseline|AGN-229666|One drop of AGN-229666 in each eye on Days 1 and 15.
66700|NCT02161146|P5|Participant Flow|AGN-229666/Vehicle|One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.
66701|NCT02161146|P4|Participant Flow|AGN-229666/Olopatadine|One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.
66702|NCT02161146|P3|Participant Flow|Olopatadine|One drop of olopatadine in each eye on Days 1 and 15.
66703|NCT02161146|P2|Participant Flow|Vehicle|One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.
66704|NCT02161146|P1|Participant Flow|AGN-229666|One drop of AGN-229666 in each eye on Days 1 and 15.
66705|NCT02161146|O3|Outcome|Olopatadine|One drop of olopatadine in the eye on Days 1 and 15.
66706|NCT02161146|O2|Outcome|Vehicle|One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.
66707|NCT02161146|O1|Outcome|AGN-229666|One drop of AGN-229666 in the eye on Days 1 and 15.
66708|NCT02161146|O3|Outcome|Olopatadine|One drop of olopatadine in the eye on Days 1 and 15.
66709|NCT02161146|O2|Outcome|Vehicle|One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.
66710|NCT02161146|O1|Outcome|AGN-229666|One drop of AGN-229666 in the eye on Days 1 and 15.
66986|NCT02158975|O1|Outcome|MLN9708|MLN9708 4mg by mouth weekly (days 1, 8, 15) every 28 days.
66716|NCT02161016|B1|Baseline|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
66717|NCT02161016|P1|Participant Flow|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
66718|NCT02161016|O1|Outcome|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
66719|NCT02161016|O1|Outcome|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
66720|NCT02161016|O1|Outcome|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
66721|NCT02161016|O1|Outcome|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
66722|NCT02161016|O1|Outcome|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
66723|NCT02161016|E1|Reported Event|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
66724|NCT02160990|B3|Baseline|Total|Total of all reporting groups
66725|NCT02160990|B2|Baseline|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
66726|NCT02160990|B1|Baseline|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
66727|NCT02160990|P2|Participant Flow|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
66728|NCT02160990|P1|Participant Flow|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
66729|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
66730|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
66731|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
66732|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
66733|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
66734|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
66735|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
66736|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
66737|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
66738|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
66739|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
66740|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
66741|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
66742|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
66743|NCT02160990|E2|Reported Event|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
66744|NCT02160990|E1|Reported Event|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
66745|NCT02160977|B3|Baseline|Total|Total of all reporting groups
66746|NCT02160977|B2|Baseline|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)~total knee arthroplasty"
66747|NCT02160977|B1|Baseline|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)~total knee arthroplasty"
66748|NCT02160977|P2|Participant Flow|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)~total knee arthroplasty"
66749|NCT02160977|P1|Participant Flow|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)~total knee arthroplasty"
66750|NCT02160977|O2|Outcome|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)~total knee arthroplasty"
66751|NCT02160977|O1|Outcome|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)~total knee arthroplasty"
66752|NCT02160977|O2|Outcome|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)~total knee arthroplasty"
66753|NCT02160977|O1|Outcome|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)~total knee arthroplasty"
66754|NCT02160977|O2|Outcome|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)~total knee arthroplasty"
66755|NCT02160977|O1|Outcome|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)~total knee arthroplasty"
66756|NCT02160977|E2|Reported Event|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)~total knee arthroplasty"
66757|NCT02160977|E1|Reported Event|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)~total knee arthroplasty"
66758|NCT02160873|B3|Baseline|Total|Total of all reporting groups
66759|NCT02160873|B2|Baseline|Flavor-matched Placebo, Then Chocolate Milk|flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before) followed by a 7-day washout, then chocolate milk 7-8 hours prior to exercise trial.
66760|NCT02160873|B1|Baseline|Chocolate Milk First, Then Placebo|chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before) followed by a 7-day washout, then placebo 7-8 hours prior to exercise trial.
66761|NCT02160873|P2|Participant Flow|Flavor-matched Placebo, Then Chocolate Milk.|Subjects received flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before). Thereafter, there was a 7 day washout period. Then, subjects received 12 oz of chocolate milk 7-8 hours prior to exercise.
66762|NCT02160873|P1|Participant Flow|Chocolate Milk, Then Placebo|Subjects received chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before). Thereafter, there was a 7 day washout period. Then, subjects received the placebo beverage 7-8 hours prior to the exercise trial.
66763|NCT02160873|O2|Outcome|Flavor-matched Placebo|Subjects received flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before). Thereafter, there was a 7 day washout period. Then, subjects received 12 oz of chocolate milk 7-8 hours prior to exercise.
66764|NCT02160873|O1|Outcome|Chocolate Milk|Subjects received chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before). Thereafter, there was a 7 day washout period. Then, subjects received the placebo beverage 7-8 hours prior to the exercise trial.
66765|NCT02160873|O2|Outcome|Flavor-matched Placebo|"In this arm, subjects receive a flavor-matched placebo~flavor-matched placebo: 12 oz, non-caloric flavor-matched placebo"
66766|NCT02160873|O1|Outcome|Chocolate Milk|"In this arm, subjects receive chocolate milk~chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before)"
66767|NCT02160873|O2|Outcome|Flavor-matched Placebo|"In this arm, subjects receive a flavor-matched placebo (in a cross-over design)~flavor-matched placebo: 12 oz, non-caloric flavor-matched placebo"
66768|NCT02160873|O1|Outcome|Chocolate Milk|"In this arm, subjects receive chocolate milk (in a cross-over design)~chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before)"
66769|NCT02160873|O2|Outcome|Flavor-matched Placebo|flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before)
66770|NCT02160873|O1|Outcome|Chocolate Milk|chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before)
66771|NCT02160873|E2|Reported Event|Flavor-matched Placebo|flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before)
66772|NCT02160873|E1|Reported Event|Chocolate Milk|chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before)
66773|NCT02160314|B3|Baseline|Total|Total of all reporting groups
66774|NCT02160314|B2|Baseline|Pessary|"disposable, single-use pessary~pessary: disposable, single-use pessary"
66775|NCT02160314|B1|Baseline|Pad Control|"absorbent pad control~Absorbent pad"
66776|NCT02160314|P2|Participant Flow|Pessary|pessary: disposable, single-use
66777|NCT02160314|P1|Participant Flow|Pad Control|absorbent pad control
66778|NCT02160314|O2|Outcome|Pessary|"disposable, single-use pessary~pessary: disposable, single-use pessary"
66779|NCT02160314|O1|Outcome|Pad Control|"absorbent pad control~Absorbent pad"
66780|NCT02160314|E2|Reported Event|Pessary|disposable, single-use pessary
66781|NCT02160314|E1|Reported Event|Pad Control|absorbent pad control
66782|NCT02160002|B3|Baseline|Total|Total of all reporting groups
66783|NCT02160002|B2|Baseline|Higher Weight (1800 Grams)|Weaning from an incubator at a higher weight (1800 grams)
66784|NCT02160002|B1|Baseline|Lower Weight (1600 Grams)|Weaning from an incubator at a lower weight (1600 grams)
66785|NCT02160002|P2|Participant Flow|Higher Weight (1800 Grams)|Weaning from an incubator at a higher weight (1800 grams)
66786|NCT02160002|P1|Participant Flow|Lower Weight (1600 Grams)|Weaning from an incubator at a lower weight (1600 grams)
66787|NCT02160002|O2|Outcome|Higher Weight (1800 Grams)|Weaning from an incubator at a higher weight (1800 grams)
66788|NCT02160002|O1|Outcome|Lower Weight (1600 Grams)|Weaning from an incubator at a lower weight (1600 grams)
66789|NCT02160002|O2|Outcome|Higher Weight (1800 Grams)|Weaning from an incubator at a higher weight (1800 grams)
66790|NCT02160002|O1|Outcome|Lower Weight (1600 Grams)|Weaning from an incubator at a lower weight (1600 grams)
66791|NCT02160002|O2|Outcome|Higher Weight (1800 Grams)|Weaning from an incubator at a higher weight (1800 grams)
66792|NCT02160002|O1|Outcome|Lower Weight (1600 Grams)|Weaning from an incubator at a lower weight (1600 grams)
66793|NCT02160002|O2|Outcome|Higher Weight (1800 Grams)|Weaning from an incubator at a higher weight (1800 grams)
66794|NCT02160002|O1|Outcome|Lower Weight (1600 Grams)|Weaning from an incubator at a lower weight (1600 grams)
66795|NCT02160002|O2|Outcome|Higher Weight (1800 Grams)|Weaning from an incubator at a higher weight (1800 grams)
66796|NCT02160002|O1|Outcome|Lower Weight (1600 Grams)|Weaning from an incubator at a lower weight (1600 grams)
66797|NCT02160002|O2|Outcome|Higher Weight (1800 Grams)|Weaning from an incubator at a higher weight (1800 grams)
66798|NCT02160002|O1|Outcome|Lower Weight (1600 Grams)|Weaning from an incubator at a lower weight (1600 grams)
66799|NCT02160002|O2|Outcome|Higher Weight (1800 Grams)|Weaning from an incubator at a higher weight (1800 grams)
66800|NCT02160002|O1|Outcome|Lower Weight (1600 Grams)|Weaning from an incubator at a lower weight (1600 grams)
66801|NCT02160002|O2|Outcome|Higher Weight (1800 Grams)|Weaning from an incubator at a higher weight (1800 grams)
66802|NCT02160002|O1|Outcome|Lower Weight (1600 Grams)|Weaning from an incubator at a lower weight (1600 grams)
66803|NCT02160002|O2|Outcome|Higher Weight (1800 Grams)|Weaning from an incubator at a higher weight (1800 grams)
66804|NCT02160002|O1|Outcome|Lower Weight (1600 Grams)|Weaning from an incubator at a lower weight (1600 grams)
66805|NCT02160002|O2|Outcome|Higher Weight (1800 Grams)|Weaning from an incubator at a higher weight (1800 grams)
66806|NCT02160002|O1|Outcome|Lower Weight (1600 Grams)|Weaning from an incubator at a lower weight (1600 grams)
66807|NCT02160002|O2|Outcome|Higher Weight (1800 Grams)|Weaning from an incubator at a higher weight (1800 grams)
66808|NCT02160002|O1|Outcome|Lower Weight (1600 Grams)|Weaning from an incubator at a lower weight (1600 grams)
66810|NCT02160002|O1|Outcome|Lower Weight (1600 Grams)|Weaning from an incubator at a lower weight (1600 grams)
66811|NCT02160002|O2|Outcome|Higher Weight (1800 Grams)|Weaning from an incubator at a higher weight (1800 grams)
66812|NCT02160002|O1|Outcome|Lower Weight (1600 Grams)|Weaning from an incubator at a lower weight (1600 grams)
66813|NCT02160002|E2|Reported Event|Higher Weight (1800 Grams)|Weaning from an incubator at a higher weight (1800 grams)
66814|NCT02160002|E1|Reported Event|Lower Weight (1600 Grams)|Weaning from an incubator at a lower weight (1600 grams)
66815|NCT02159950|B3|Baseline|Total|Total of all reporting groups
66816|NCT02159950|B2|Baseline|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
66817|NCT02159950|B1|Baseline|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
66818|NCT02159950|P2|Participant Flow|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
66819|NCT02159950|P1|Participant Flow|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
66820|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
66821|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
66822|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
66823|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
66824|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
66825|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
66826|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
66827|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
66828|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
66829|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
66830|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
66831|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
66832|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
66856|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
66857|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
66833|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
66834|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
66835|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
66836|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
66837|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
66838|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
66839|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
66840|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
66841|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
66842|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
66843|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
66844|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
66845|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
66846|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
66847|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
66848|NCT02159950|E2|Reported Event|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
66849|NCT02159950|E1|Reported Event|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
66850|NCT02159859|B1|Baseline|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
66851|NCT02159859|P1|Participant Flow|Ertapenem|"Subjects with end stage renal disease (ESRD) who undergo hemodialysis three times a week and without infection will be administered one gram of ertapenem once over five minutes through infusion access after a hemodialysis session, and will have blood drawn at time 0, 0.5, 1, 2, 6, and 12 hours after the ertapenem administration and once prior to the next hemodialysis session~Ertapenem: Subjects are hemodialysis patients who are admitted to Oakwood Hospital - Dearborn"
66852|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
66853|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
66854|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
66855|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
66858|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
66859|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
66860|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
66861|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
66862|NCT02159859|E1|Reported Event|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
66863|NCT02159768|B1|Baseline|Airtraq Visualization|"Larynx visualization with Airtraq and attached handphone~Airtraq visualization: Larynx visualization with Airtraq and attached handphone"
66864|NCT02159768|P1|Participant Flow|Airtraq Visualization|"Larynx visualization with Airtraq and attached handphone~Airtraq visualization: Larynx visualization with Airtraq and attached handphone"
66865|NCT02159768|O1|Outcome|Airtraq Visualization|"Larynx visualization with Airtraq and attached handphone~Airtraq visualization: Larynx visualization with Airtraq and attached handphone"
66866|NCT02159768|O1|Outcome|Airtraq Visualization|"Larynx visualization with Airtraq and attached handphone~Airtraq visualization: Larynx visualization with Airtraq and attached handphone"
66867|NCT02159768|E1|Reported Event|Airtraq Visualization|"Larynx visualization with Airtraq and attached handphone~Airtraq visualization: Larynx visualization with Airtraq and attached handphone"
66868|NCT02159547|B3|Baseline|Total|Total of all reporting groups
66869|NCT02159547|B2|Baseline|Normal Slaline|"50 ml normal saline~Normal Saline: 50 ml normal saline"
66870|NCT02159547|B1|Baseline|Dexketoprofen|"50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.~Dexketoprofen: 50 mg intravenous arveles in 50 ml saline in 5 minutes"
66871|NCT02159547|P2|Participant Flow|Normal Slaline|"50 ml normal saline~Normal Saline: 50 ml normal saline"
66872|NCT02159547|P1|Participant Flow|Dexketoprofen|"50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.~Dexketoprofen: 50 mg intravenous arveles in 50 ml saline in 5 minutes"
66873|NCT02159547|O2|Outcome|Normal Slaline|"50 ml normal saline~Normal Saline: 50 ml normal saline"
66874|NCT02159547|O1|Outcome|Dexketoprofen|"50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.~Dexketoprofen: 50 mg intravenous arveles in 50 ml saline in 5 minutes"
66875|NCT02159547|O2|Outcome|Normal Slaline|"50 ml normal saline~Normal Saline: 50 ml normal saline"
66876|NCT02159547|O1|Outcome|Dexketoprofen|50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.
66877|NCT02159547|E2|Reported Event|Normal Slaline|"50 ml normal saline~Normal Saline: 50 ml normal saline"
66878|NCT02159547|E1|Reported Event|Dexketoprofen|"50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.~Dexketoprofen: 50 mg intravenous arveles in 50 ml saline in 5 minutes"
66879|NCT02159482|B1|Baseline|Interferon-alfa-2a|"Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.~Interferon Alfa-2a"
66880|NCT02159482|P1|Participant Flow|Interferon-alfa-2a|"Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.~Interferon Alfa-2a"
66881|NCT02159482|O1|Outcome|Interferon-alfa-2a|"Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.~Interferon Alfa-2a"
66882|NCT02159482|O1|Outcome|Interferon-alfa-2a|"Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.~Interferon Alfa-2a"
66883|NCT02159482|E1|Reported Event|Interferon-alfa-2a|"Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.~Interferon Alfa-2a"
66884|NCT02159469|B1|Baseline|Testosterone Enanthate Auto-injector|"Testosterone enanthate administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.~Testosterone enanthate auto-injector Dose Adjustment: 50 mg / 75 mg / 100 mg"
66885|NCT02159469|P1|Participant Flow|QST 50 mg / 75 mg / 100 mg|Testosterone enanthate 50 mg / 75 mg / 100 mg dose administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
66886|NCT02159469|O1|Outcome|Testosterone Enanthate Auto-injector|"Testosterone enanthate administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.~Testosterone enanthate auto-injector Dose Adjustment 50 mg / 75 mg / 100 mg"
66887|NCT02159469|O1|Outcome|Testosterone Enanthate Auto-injector|Testosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
66888|NCT02159469|E1|Reported Event|Testosterone Enanthate Auto-injector|"Testosterone enanthate administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.~Testosterone enanthate auto-injector Dose Adjustment 50 mg / 75 mg / 100 mg"
66889|NCT02159365|B1|Baseline|E-Ld|"E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.~During cycles 1 and 2, elotuzumab was provided weekly as a intravenous 10 mg/kg solution on days 1, 8, 15, and 22. During cycles 3 and beyond, elotuzumab was provided every other week on days 1 and 15.~During each cycle, Lenalidomide was provided as a 25 mg tablet by mouth on days 1-21 and Dexamethasone at a dose of 40 mg/week was administered orally on weeks without elotuzumab infusion. On weeks of elotuzumab infusion, 28 mg was to be administered orally and 8 mg was administered intravenously as part of elotuzumab premedication regimen until progression or discontinuation of Elotuzumab.~A cycle was defined as 28 days. Treatment with study drug continued until disease progression, unacceptable toxicity, or subject met other criteria for discontinuation of study drugs."
66915|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
66985|NCT02158975|P1|Participant Flow|MLN9708|"MLN9708 4mg by mouth weekly (days 1, 8, 15) every 28 days.~MLN9708"
66890|NCT02159365|P1|Participant Flow|E-Ld|"E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.~During cycles 1 and 2, elotuzumab was provided weekly as a intravenous 10 mg/kg solution on days 1, 8, 15, and 22. During cycles 3 and beyond, elotuzumab was provided every other week on days 1 and 15.~During each cycle, Lenalidomide was provided as a 25 mg tablet by mouth on days 1-21 and Dexamethasone at a dose of 40 mg/week was administered orally on weeks without elotuzumab infusion. On weeks of elotuzumab infusion, 28 mg was to be administered orally and 8 mg was administered intravenously as part of elotuzumab premedication regimen until progression or discontinuation of Elotuzumab.~A cycle was defined as 28 days. Treatment with study drug continued until disease progression, unacceptable toxicity, or subject met other criteria for discontinuation of study drugs."
66891|NCT02159365|O1|Outcome|E-Ld|"E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.~During cycles 1 and 2, elotuzumab was provided weekly as a intravenous 10 mg/kg solution on days 1, 8, 15, and 22. During cycles 3 and beyond, elotuzumab was provided every other week on days 1 and 15.~During each cycle, Lenalidomide was provided as a 25 mg tablet by mouth on days 1-21 and Dexamethasone at a dose of 40 mg/week was administered orally on weeks without elotuzumab infusion. On weeks of elotuzumab infusion, 28 mg was to be administered orally and 8 mg was administered intravenously as part of elotuzumab premedication regimen until progression or discontinuation of Elotuzumab.~A cycle was defined as 28 days. Treatment with study drug continued until disease progression, unacceptable toxicity, or subject met other criteria for discontinuation of study drugs."
66892|NCT02159365|E1|Reported Event|E-Ld|"E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.~During cycles 1 and 2, elotuzumab was provided weekly as a intravenous 10 mg/kg solution on days 1, 8, 15, and 22. During cycles 3 and beyond, elotuzumab was provided every other week on days 1 and 15.~During each cycle, Lenalidomide was provided as a 25 mg tablet by mouth on days 1-21 and Dexamethasone at a dose of 40 mg/week was administered orally on weeks without elotuzumab infusion. On weeks of elotuzumab infusion, 28 mg was to be administered orally and 8 mg was administered intravenously as part of elotuzumab premedication regimen until progression or discontinuation of Elotuzumab.~A cycle was defined as 28 days. Treatment with study drug continued until disease progression, unacceptable toxicity, or subject met other criteria for discontinuation of study drugs."
66893|NCT02159352|B3|Baseline|Total|Total of all reporting groups
66894|NCT02159352|B2|Baseline|Daclatasvir + Lopinavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily, along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
66895|NCT02159352|B1|Baseline|Daclatasvir + Darunavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily, along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
66896|NCT02159352|P2|Participant Flow|Daclatasvir + Lopinavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily, along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
66897|NCT02159352|P1|Participant Flow|Daclatasvir + Darunavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily, along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
66898|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
66899|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
66900|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
66901|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
66902|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/ 50-mg ritonavir tablets twice daily on Days 5 through 14.
66903|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
66904|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
66905|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
66906|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/ 50-mg ritonavir tablets twice daily on Days 5 through 14.
66907|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
66908|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and 100-mg ritonavir capsule once daily on Days 5 through 14.
66909|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
66910|NCT02159352|O2|Outcome|Group 2: Daclatasvir + Lopinavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily, along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
66911|NCT02159352|O1|Outcome|Group 1: Daclatasvir + Darunavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
66912|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 -mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
66913|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
66914|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
66916|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
66917|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
66918|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
66919|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
66920|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/ 50-mg ritonavir tablets twice daily on Days 5 through 14.
66921|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received 60 mg of daclatasvir tablet once daily from Day 1 through 4.
66922|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
66923|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
66924|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
66925|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received 60 mg of daclatasvir tablet once daily from Day 1 through 4.
66926|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
66927|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
66928|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
66929|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
66930|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
66931|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
66932|NCT02159352|O4|Outcome|Daclatasvir (30 mg) + Lopinavir/Ritonavir Days 5-14|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily Days 5 through 14.
66933|NCT02159352|O3|Outcome|Daclatasvir (60 mg) Days 5-14|Participants received a 60-mg daclatasvir tablet once daily on Days 5 through 14.
66934|NCT02159352|O2|Outcome|Daclatasvir (30 mg) + Darunavir/Ritonavir Days 5-14|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
66935|NCT02159352|O1|Outcome|Daclatasvir (60 mg) Days 1-4|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
66936|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily Days 5 through 14.
66937|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 5 through 14.
66938|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily, along with an 800-mg darunavir tablet, and a 100-mg ritonavir capsule once daily on Days 5 through 14.
66939|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
66940|NCT02159352|E6|Reported Event|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/ 50-mg ritonavir tablets twice daily on Days 5 through 14.
66941|NCT02159352|E5|Reported Event|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
66942|NCT02159352|E4|Reported Event|Group 2: Total|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100­-mg ritonavir capsule once daily on Days 5 through 14.
66943|NCT02159352|E3|Reported Event|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg of ritonavir capsule once daily on Days 5 through 14.
66944|NCT02159352|E2|Reported Event|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
66945|NCT02159352|E1|Reported Event|Group 1: Total|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and 30 mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg of ritonavir capsule once daily on Days 5 through 14.
66946|NCT02159118|B3|Baseline|Total|Total of all reporting groups
66947|NCT02159118|B2|Baseline|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
66948|NCT02159118|B1|Baseline|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
66949|NCT02159118|P2|Participant Flow|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
66980|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
66981|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
66950|NCT02159118|P1|Participant Flow|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
66951|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
66952|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
66953|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
66954|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
66955|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
66956|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
66957|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
66958|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
66959|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
66960|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
66961|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
66962|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
66963|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
66964|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
66965|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
66966|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
66967|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
66968|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
66969|NCT02159118|E2|Reported Event|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
66970|NCT02159118|E1|Reported Event|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
66971|NCT02159040|B1|Baseline|Azacitidine|75mg/m2 7days/28 day cycle
66972|NCT02159040|P1|Participant Flow|Azacitidine|75mg/m2 7days/28 day cycle
66973|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
66974|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
66975|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
66976|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
66977|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
66978|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
66979|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
66987|NCT02158975|O1|Outcome|MLN9708|"MLN9708 4mg by mouth weekly (days 1, 8, 15) every 28 days.~MLN9708"
66988|NCT02158975|O1|Outcome|MLN9708|"MLN9708 4mg by mouth weekly (days 1, 8, 15) every 28 days.~MLN9708"
66989|NCT02158975|O1|Outcome|MLN9708|"MLN9708 4mg by mouth weekly (days 1, 8, 15) every 28 days.~MLN9708"
66990|NCT02158975|O1|Outcome|MLN9708|"MLN9708 4mg by mouth weekly (days 1, 8, 15) every 28 days.~MLN9708"
66991|NCT02158975|E1|Reported Event|MLN9708|MLN9708 4mg by mouth weekly (days 1, 8, 15) every 28 days.
66992|NCT02158936|B3|Baseline|Total|Total of all reporting groups
66993|NCT02158936|B2|Baseline|Placebo|Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator’s assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine
66994|NCT02158936|B1|Baseline|Eltrombopag|Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine
66995|NCT02158936|P2|Participant Flow|Placebo|Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator’s assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine
66996|NCT02158936|P1|Participant Flow|Eltrombopag|Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine
66997|NCT02158936|O2|Outcome|Placebo|Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator’s assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine
66998|NCT02158936|O1|Outcome|Eltrombopag|Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine
66999|NCT02158936|O2|Outcome|Placebo|Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator’s assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine
67000|NCT02158936|O1|Outcome|Eltrombopag|Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine
67001|NCT02158936|O1|Outcome|Eltrombopag|Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine
67058|NCT02158442|O1|Outcome|Treatment Group|The Treatment Group received intravenous Timentin prior to their PILP procedure.
67059|NCT02158442|E2|Reported Event|Control Group|The Control Group received standard dosings of intravenous Timentin plus other standard care.
67060|NCT02158442|E1|Reported Event|Treatment Group|The Treatment Group received intravenous Timentin prior to their PILP procedure.
67002|NCT02158936|O1|Outcome|Eltrombopag|Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine
67003|NCT02158936|O2|Outcome|Placebo|Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator’s assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine
67004|NCT02158936|O1|Outcome|Eltrombopag|Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine
67005|NCT02158936|O2|Outcome|Placebo|Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator’s assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine
67006|NCT02158936|O1|Outcome|Eltrombopag|Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine
67007|NCT02158936|O2|Outcome|Placebo|Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator’s assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine
67008|NCT02158936|O1|Outcome|Eltrombopag|Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine
67009|NCT02158936|O2|Outcome|Placebo|Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator’s assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine
67010|NCT02158936|O1|Outcome|Eltrombopag|Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine
67011|NCT02158936|O2|Outcome|Placebo|Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator’s assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine
67061|NCT02158364|B1|Baseline|Live Attenuated Measles/Rubella Combined Vaccine|Live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) is dissolved in 0.7 mL of accompanying reconstitution fluid (water for injection [Japanese Pharmacopoeia]), and a 0.5-mL portion is typically administered subcutaneously as a single dose. Participants received interventions as part of routine medical care.
67141|NCT02157909|E1|Reported Event|Pre-treatment|Includes all subjects / eyes prior to the exposure to the investigational or control products
67012|NCT02158936|O1|Outcome|Eltrombopag|Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine
67013|NCT02158936|O2|Outcome|Placebo|Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator’s assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine
67014|NCT02158936|O1|Outcome|Eltrombopag|Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine
67015|NCT02158936|O2|Outcome|Placebo|Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator’s assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine
67016|NCT02158936|O1|Outcome|Eltrombopag|Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine
67017|NCT02158936|O2|Outcome|Placebo|Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator’s assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine
67018|NCT02158936|O1|Outcome|Eltrombopag|Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine
67019|NCT02158936|O2|Outcome|Placebo|Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator’s assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine
67020|NCT02158936|O1|Outcome|Eltrombopag|Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine
67021|NCT02158936|O2|Outcome|Placebo|Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator’s assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine
67062|NCT02158364|P1|Participant Flow|Live Attenuated Measles/Rubella Combined Vaccine|Live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) is dissolved in 0.7 mL of accompanying reconstitution fluid (water for injection [Japanese Pharmacopoeia]), and a 0.5-mL portion is typically administered subcutaneously as a single dose. Participants received interventions as part of routine medical care.
67233|NCT02157116|B1|Baseline|All Subjects|All subjects who signed a consent form are included, whether or not they received treatment as a part of the study.
67022|NCT02158936|O1|Outcome|Eltrombopag|Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine
67023|NCT02158936|O2|Outcome|Placebo|Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator’s assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine
67024|NCT02158936|O1|Outcome|Eltrombopag|Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine
67025|NCT02158936|O2|Outcome|Placebo|Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator’s assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine
67026|NCT02158936|O1|Outcome|Eltrombopag|Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine
67027|NCT02158936|O2|Outcome|Placebo|Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator’s assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine
67028|NCT02158936|O1|Outcome|Eltrombopag|Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine
67029|NCT02158936|O2|Outcome|Placebo|Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator’s assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine
67030|NCT02158936|O1|Outcome|Eltrombopag|Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine
67031|NCT02158936|O2|Outcome|Placebo|Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator’s assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine
67063|NCT02158364|O1|Outcome|Live Attenuated Measles/Rubella Combined Vaccine|Live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) is dissolved in 0.7 mL of accompanying reconstitution fluid (water for injection [Japanese Pharmacopoeia]), and a 0.5-mL portion is typically administered subcutaneously as a single dose. Participants received interventions as part of routine medical care.
67234|NCT02157116|P1|Participant Flow|All Subjects|All subjects who signed a consent form are included, whether or not they received treatment as a part of the study.
67235|NCT02157116|O1|Outcome|Treated Patients|
67032|NCT02158936|O1|Outcome|Eltrombopag|Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine
67033|NCT02158936|O2|Outcome|Placebo|Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator’s assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine
67034|NCT02158936|O1|Outcome|Eltrombopag|Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine
67035|NCT02158936|E2|Reported Event|Placebo|Placebo
67036|NCT02158936|E1|Reported Event|Eltrombopag|Eltrombopag
67037|NCT02158728|B1|Baseline|ICD Indicated Subjects|Subjects indicated for implantable cardioverter defibrillator (ICD)/cardiac resynchronization therapy defibrillator (CRT-D) implant, ICD/CRT-D change-out, or indicated for an ICD/CRT-D and undergoing ablation or electrophysiology (EP) study (including Non-Invasive ElectroPhysiology Study [NIPS]).
67038|NCT02158728|P1|Participant Flow|ICD Indicated Subjects|"Subjects indicated for ICD/CRT-D implant, ICD/CRT-D change-out, or indicated for an ICD/CRT-D and undergoing ablation or electrophysiology (EP) study (including Non-invasive EP study [NIPS])~ICD: implantable cardioverter defibrillator CRT-D: cardiac resynchronization therapy defibrillator"
67039|NCT02158728|O1|Outcome|ICD Indicated Subjects|From the initially 80 enrolled subjects indicated for ICD/CRT-D implant, ICD/CRT-D change-out, or indicated for an ICD/CRT-D and undergoing ablation or EP study (including Non-invasive EP Study [NIPS]), 53 subjects provided SVT episode data which qualified for developing and testing new sensing and detection algorithms for a new MedtronicICD. SVT episodes with a ventricular response rate of ≥170 BPM are required in the development of the algorithms.
67040|NCT02158728|E1|Reported Event|ICD Indicated Subjects|Only ICD-indicated subjects undergoing standard ICD/CRT-D implant, ICD/CRT-D change-out, ablation, electrophysiology (EP) study or Non Invasive Programmed Stimulation (NIPS), and who provided a dataset which qualified for developing and testing the sensing and detection algorithms of the new ICD, are included in the analyses.
67041|NCT02158572|B1|Baseline|AG200-15|"AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG)~AG200-15: Transdermal contraceptive delivery system"
67042|NCT02158572|P1|Participant Flow|AG200-15|"AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG)~AG200-15: Transdermal contraceptive delivery system"
67043|NCT02158572|O1|Outcome|AG200-15|"AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG)~AG200-15: Transdermal contraceptive delivery system"
67044|NCT02158572|O1|Outcome|AG200-15|"AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG)~AG200-15: Transdermal contraceptive delivery system"
67045|NCT02158572|O1|Outcome|AG200-15|"AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG)~AG200-15: Transdermal contraceptive delivery system"
67046|NCT02158572|O1|Outcome|AG200-15|"AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG)~AG200-15: Transdermal contraceptive delivery system"
67047|NCT02158572|O1|Outcome|AG200-15|"AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG)~AG200-15: Transdermal contraceptive delivery system"
67048|NCT02158572|O1|Outcome|AG200-15|"AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG)~AG200-15: Transdermal contraceptive delivery system"
67049|NCT02158572|O1|Outcome|AG200-15|"AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG)~AG200-15: Transdermal contraceptive delivery system"
67050|NCT02158572|O1|Outcome|AG200-15|"AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG)~AG200-15: Transdermal contraceptive delivery system"
67051|NCT02158572|E1|Reported Event|AG200-15|"AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG)~AG200-15: Transdermal contraceptive delivery system"
67052|NCT02158442|B3|Baseline|Total|Total of all reporting groups
67053|NCT02158442|B2|Baseline|Control Group|The Control Group received standard dosings of intravenous Timentin plus other standard care.
67054|NCT02158442|B1|Baseline|Treatment Group|The Treatment Group received intravenous Timentin prior to their PILP procedure.
67055|NCT02158442|P2|Participant Flow|Control Group|The Control Group received standard dosings of intravenous Timentin plus other standard care.
67056|NCT02158442|P1|Participant Flow|Treatment Group|The Treatment Group received intravenous Timentin prior to their PILP procedure.
67057|NCT02158442|O2|Outcome|Control Group|The Control Group received standard dosings of intravenous Timentin plus other standard care.
67236|NCT02157116|O1|Outcome|Treated Patients|
67064|NCT02158364|O1|Outcome|Live Attenuated Measles/Rubella Combined Vaccine|Live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) is dissolved in 0.7 mL of accompanying reconstitution fluid (water for injection [Japanese Pharmacopoeia]), and a 0.5-mL portion is typically administered subcutaneously as a single dose. Participants received interventions as part of routine medical care.
67065|NCT02158364|E1|Reported Event|Live Attenuated Measles/Rubella Combined Vaccine|Live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) is dissolved in 0.7 mL of accompanying reconstitution fluid (water for injection [Japanese Pharmacopoeia]), and a 0.5-mL portion is typically administered subcutaneously as a single dose. Participants received interventions as part of routine medical care.
67066|NCT02158273|B3|Baseline|Total|Total of all reporting groups
67067|NCT02158273|B2|Baseline|Placebo|Matched Placebo
67068|NCT02158273|B1|Baseline|Fenofibrate|TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days
67069|NCT02158273|P2|Participant Flow|Placebo|Matched Placebo
67070|NCT02158273|P1|Participant Flow|Fenofibrate|TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days
67071|NCT02158273|O2|Outcome|Placebo|Matched Placebo
67072|NCT02158273|O1|Outcome|Fenofibrate|TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days
67073|NCT02158273|O2|Outcome|Placebo|Matched Placebo
67074|NCT02158273|O1|Outcome|Fenofibrate|TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days
67075|NCT02158273|E2|Reported Event|Placebo|Matched Placebo
67076|NCT02158273|E1|Reported Event|Fenofibrate|TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days
67077|NCT02158247|B3|Baseline|Total|Total of all reporting groups
67078|NCT02158247|B2|Baseline|Touch and Read Group(Female)|female
67079|NCT02158247|B1|Baseline|Touch and Read Group(Male)|"This is a virtual experiment based on the anthropometry of the airway length. We defined the conventional group as patients who are intubated on the depth of 25cm for male and 23 cm fo female from the medial incisor virtually.~Touch and read group : Depth of intubation was determined on the measurement of the airway length of each patient. In touch and read group, the depth of intubation was determined by the sum of the length from the mouth angle to epiglottis tip, the length from the epiglottis tip to vocal cords and 8cm for the endotracheal tube #7.0. Length from the mouth angle to epiglottis tip is determined at the time of intubation with specially scaled endotracheal tube."
67080|NCT02158247|P1|Participant Flow|Tough and Read Group|"This is a virtual experiment based on the anthropometry of the airway length. Conventional group : We defined the conventional group as patients who are intubated on the depth of 25cm for male and 23 cm fo female from the medial incisor virtually.~Touch and read group : Depth of intubation was determined on the measurement of the airway length of each patient. In touch and read group, the depth of intubation was determined by the sum of the length from the mouth angle to epiglottis tip, the length from the epiglottis tip to vocal cords and 8cm for the endotracheal tube #7.0. Length from the mouth angle to epiglottis tip is determined at the time of intubation with specially scaled endotracheal tube."
67081|NCT02158247|O1|Outcome|Female Airway Length vs Height|"Relationship between airway length and their height are analyzed with linear regression.~Airway length is defined the distance from mouth angle to carina. Additionally it is divided into three parts, from mouth angle to epiglottis tip, epiglottis tip to vocal cords and vocal cords to carina."
67082|NCT02158247|O1|Outcome|Airway Length vs Height in Male|"Relationship between airway length and their height are analyzed with linear regression.~Airway length is defined the distance from mouth angle to carina. Additionally it is divided into three parts, from mouth angle to epiglottis tip, epiglottis tip to vocal cords and vocal cords to carina."
67083|NCT02158247|O2|Outcome|Touch and Read for Normal Group of Female|
67084|NCT02158247|O1|Outcome|Conventional Method for Normal Group of Female|
67085|NCT02158247|O2|Outcome|Touch and Read for Risk Group of Female|
67086|NCT02158247|O1|Outcome|Conventional Method for Risk Group of Female|
67087|NCT02158247|O2|Outcome|Touch and Read for Normal Group of Male|
67088|NCT02158247|O1|Outcome|Conventional Method for Normal Group of Male|
67089|NCT02158247|O2|Outcome|Touch and Read for Risk Group of Male|
67090|NCT02158247|O1|Outcome|Conventional Method for Risk Group of Male|
67091|NCT02158247|O2|Outcome|Airway Length of Female|
67092|NCT02158247|O1|Outcome|Airway Length for Male|
67093|NCT02158247|E2|Reported Event|Touch and Read Group(Female)|female
67094|NCT02158247|E1|Reported Event|Touch and Read Group(Male)|"This is a virtual experiment based on the anthropometry of the airway length. We defined the conventional group as patients who are intubated on the depth of 25cm for male and 23 cm fo female from the medial incisor virtually.~Touch and read group : Depth of intubation was determined on the measurement of the airway length of each patient. In touch and read group, the depth of intubation was determined by the sum of the length from the mouth angle to epiglottis tip, the length from the epiglottis tip to vocal cords and 8cm for the endotracheal tube #7.0. Length from the mouth angle to epiglottis tip is determined at the time of intubation with specially scaled endotracheal tube."
67095|NCT02158039|B1|Baseline|Pancreatic Cyst Ethanol Injection|EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
67096|NCT02158039|P1|Participant Flow|Pancreatic Cyst Ethanol Injection|Endoscopic ultrasound (EUS)-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
67138|NCT02157909|O1|Outcome|AOA Modified|Modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
67139|NCT02157909|E3|Reported Event|AOA Sphere|Includes all subjects / eyes exposed to AOA Sphere lenses
67140|NCT02157909|E2|Reported Event|AOA Modified|Includes all subjects / eyes exposed to AOA Modified lenses
67097|NCT02158039|O1|Outcome|Pancreatic Cyst Ethanol Injection|EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
67098|NCT02158039|O1|Outcome|Pancreatic Cyst Ethanol Injection|EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
67099|NCT02158039|E1|Reported Event|Pancreatic Cyst Ethanol Injection|EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
67100|NCT02157948|B3|Baseline|Total|Total of all reporting groups
67101|NCT02157948|B2|Baseline|Denosumab CP4|Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.
67102|NCT02157948|B1|Baseline|Denosumab CP2|Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year.
67103|NCT02157948|P2|Participant Flow|Denosumab CP4|Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.
67104|NCT02157948|P1|Participant Flow|Denosumab CP2|Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year.
67105|NCT02157948|O2|Outcome|Denosumab CP4|Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.
67106|NCT02157948|O1|Outcome|Denosumab CP2|Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year.
67107|NCT02157948|O2|Outcome|Denosumab CP4|Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.
67108|NCT02157948|O1|Outcome|Denosumab CP2|Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year.
67109|NCT02157948|O2|Outcome|Denosumab CP4|Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.
67110|NCT02157948|O1|Outcome|Denosumab CP2|Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year.
67111|NCT02157948|E2|Reported Event|Denosumab CP4|Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.
67112|NCT02157948|E1|Reported Event|Denosumab CP2|Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year.
67113|NCT02157935|B3|Baseline|Total|Total of all reporting groups
67114|NCT02157935|B2|Baseline|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
67115|NCT02157935|B1|Baseline|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
67116|NCT02157935|P2|Participant Flow|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
67117|NCT02157935|P1|Participant Flow|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
67118|NCT02157935|O2|Outcome|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
67119|NCT02157935|O1|Outcome|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
67120|NCT02157935|O2|Outcome|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
67121|NCT02157935|O1|Outcome|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
67122|NCT02157935|O2|Outcome|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
67123|NCT02157935|O1|Outcome|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
67124|NCT02157935|O2|Outcome|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
67125|NCT02157935|O1|Outcome|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
67126|NCT02157935|O2|Outcome|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
67127|NCT02157935|O1|Outcome|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
67128|NCT02157935|O2|Outcome|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
67129|NCT02157935|O1|Outcome|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
67130|NCT02157935|E2|Reported Event|Symbicort 160/4.5 ug x2 Bid|
67131|NCT02157935|E1|Reported Event|Formoterol 4.5 ug x2 Bid|
67132|NCT02157909|B3|Baseline|Total|Total of all reporting groups
67133|NCT02157909|B2|Baseline|AOA Sphere|Sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
67134|NCT02157909|B1|Baseline|AOA Modified|Modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
67135|NCT02157909|P2|Participant Flow|AOA Sphere|Sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
67136|NCT02157909|P1|Participant Flow|AOA Modified|Modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
67137|NCT02157909|O2|Outcome|AOA Sphere|Sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
67142|NCT02157883|B1|Baseline|AZD9291 and Itraconozole (Part A); AZD9291 Alone (Part B)|"In Part A of the study, sequential treatments of AZD9291 alone (including a washout) followed by AZD9291+itraconazole. Each patient received single 80 mg oral doses of AZD9291 tablets on Days 1 and 10, and in addition received itraconazole capsules 200 mg twice daily on Days 6 to 18.~In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation."
67143|NCT02157883|P1|Participant Flow|AZD9291 and Itraconozole (Part A); AZD9291 Alone (Part B)|"In Part A of the study, sequential treatments of AZD9291 alone (including a washout) followed by AZD9291+itraconazole. Each patient received single 80 mg oral doses of AZD9291 tablets on Days 1 and 10, and in addition received itraconazole capsules 200 mg twice daily on Days 6 to 18.~In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation."
67144|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
67145|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
67146|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
67147|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
67148|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
67149|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
67150|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
67151|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
67152|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
67153|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
67154|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
67155|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
67156|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
67157|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
67158|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
67159|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
67160|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
67161|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
67162|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
67163|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
67164|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
67165|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
67166|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
67167|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
67168|NCT02157883|E3|Reported Event|Part B Safety Population|In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation.
67169|NCT02157883|E2|Reported Event|Part A Safety Population|In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods (AZD9291 dosing on Days 1 and 10). Patients additionally received itraconazole 200 mg twice daily dosing from Days 6 to 18.
67170|NCT02157883|E1|Reported Event|Overall Safety Population|Parts A and B of the study combined.
67171|NCT02157623|B3|Baseline|Total|Total of all reporting groups
67172|NCT02157623|B2|Baseline|Blue Light Photodynamic Therapy|"Subject will be randomized to right or left side and assigned side will be treated with blue light PDT after Levulan application~Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields~Blue Light Photodynamic Therapy: Blu-U® (blue lamp) after Levulan application on randomized treatment field"
67173|NCT02157623|B1|Baseline|Red Light Photodynamic Therapy|"Subject will be randomized to right or left side and assigned side will be treated with red light PDT after Levulan application~Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields~Red Light Photodynamic Therapy: Aktilite™ (red lamp) after Levulan application on randomized treatment field"
67174|NCT02157623|P2|Participant Flow|Blue Light Photodynamic Therapy|"Subject will be randomized to right or left side and assigned side will be treated with blue light PDT after Levulan application~Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields~Blue Light Photodynamic Therapy: Blu-U® (blue lamp) after Levulan application on randomized treatment field"
67175|NCT02157623|P1|Participant Flow|Red Light Photodynamic Therapy|"Subject will be randomized to right or left side and assigned side will be treated with red light PDT after Levulan application~Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields~Red Light Photodynamic Therapy: Aktilite™ (red lamp) after Levulan application on randomized treatment field"
67176|NCT02157623|O2|Outcome|Blue Light Photodynamic Therapy|"Subject will be randomized to right or left side and assigned side will be treated with blue light PDT after Levulan application~Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields~Blue Light Photodynamic Therapy: Blu-U® (blue lamp) after Levulan application on randomized treatment field"
67177|NCT02157623|O1|Outcome|Red Light Photodynamic Therapy|"Subject will be randomized to right or left side and assigned side will be treated with red light PDT after Levulan application~Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields~Red Light Photodynamic Therapy: Aktilite™ (red lamp) after Levulan application on randomized treatment field"
67237|NCT02157116|O1|Outcome|Treated Patients|
67238|NCT02157116|O1|Outcome|Treated Patients|
67239|NCT02157116|O1|Outcome|Treated Patients|
67178|NCT02157623|E2|Reported Event|Blue Light Photodynamic Therapy|"Subject will be randomized to right or left side and assigned side will be treated with blue light PDT after Levulan application~Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields~Blue Light Photodynamic Therapy: Blu-U® (blue lamp) after Levulan application on randomized treatment field"
67179|NCT02157623|E1|Reported Event|Red Light Photodynamic Therapy|"Subject will be randomized to right or left side and assigned side will be treated with red light PDT after Levulan application~Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields~Red Light Photodynamic Therapy: Aktilite™ (red lamp) after Levulan application on randomized treatment field"
67180|NCT02157376|B3|Baseline|Total|Total of all reporting groups
67181|NCT02157376|B2|Baseline|Cimetidine|iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days
67182|NCT02157376|B1|Baseline|Esomeprazole|iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days
67183|NCT02157376|P2|Participant Flow|Cimetidine|iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days
67184|NCT02157376|P1|Participant Flow|Esomeprazole|iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days
67185|NCT02157376|O2|Outcome|Cimetidine|iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days
67186|NCT02157376|O1|Outcome|Esomeprazole|iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days
67187|NCT02157376|O2|Outcome|Cimetidine|iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days
67188|NCT02157376|O1|Outcome|Esomeprazole|iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days
67189|NCT02157376|E2|Reported Event|Esomeprazole|iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days
67190|NCT02157376|E1|Reported Event|Cimetidine|iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days
67191|NCT02157298|B3|Baseline|Total|Total of all reporting groups
67192|NCT02157298|B2|Baseline|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
67193|NCT02157298|B1|Baseline|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
67194|NCT02157298|P2|Participant Flow|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
67195|NCT02157298|P1|Participant Flow|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
67196|NCT02157298|O2|Outcome|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
67197|NCT02157298|O1|Outcome|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
67198|NCT02157298|O2|Outcome|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
67199|NCT02157298|O1|Outcome|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
67200|NCT02157298|O2|Outcome|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
67201|NCT02157298|O1|Outcome|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
67202|NCT02157298|O2|Outcome|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
67203|NCT02157298|O1|Outcome|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
67204|NCT02157298|O2|Outcome|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
67205|NCT02157298|O1|Outcome|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
67206|NCT02157298|E2|Reported Event|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
67207|NCT02157298|E1|Reported Event|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
67208|NCT02157168|B4|Baseline|Total|Total of all reporting groups
67209|NCT02157168|B3|Baseline|Intervention Group (IG2)|"Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.~The intervention group was made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate."
67210|NCT02157168|B2|Baseline|Intervention Group (IG1)|"Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.~The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it."
67211|NCT02157168|B1|Baseline|Control Group (CG)|Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker. Those not invited constituted the usual care control group..
67212|NCT02157168|P3|Participant Flow|Intervention Group (IG2)|"Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.~The intervention group was made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate."
67213|NCT02157168|P2|Participant Flow|Intervention Group (IG1)|"Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.~The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it."
67214|NCT02157168|P1|Participant Flow|Control Group (CG)|Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker. Those not invited constituted the usual care control group.
67240|NCT02157116|O1|Outcome|Treated Patients|
67241|NCT02157116|E1|Reported Event|Treated Patients|Due to insufficient accrual, adverse event data was not analyzed.
67824|NCT02153398|B5|Baseline|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
67215|NCT02157168|O3|Outcome|6-Month Follow-up: Control Group (CG)&Intervention Group (IG2)|"Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker.~CG and IG2 at 6-Month Follow-up: Those not invited constituted the usual care control group (CG). The intervention group was made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate."
67216|NCT02157168|O2|Outcome|6-Month Follow-up: Intervention Group (IG1)|"Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.~IG1 at 6-Month Follow-up: The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it."
67217|NCT02157168|O1|Outcome|Baseline: Intervention Group (IG1)|"Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.~IG1 at Baseline: The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it."
67218|NCT02157168|O3|Outcome|Intervention Group (IG2)|"Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.~The intervention group was made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate."
67219|NCT02157168|O2|Outcome|Intervention Group (IG1)|"Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.~The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it."
67220|NCT02157168|O1|Outcome|Control Group (CG)|Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker. Those not invited constituted the usual care control group.
67221|NCT02157168|O3|Outcome|Intervention Group (IG2)|"Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.~The intervention group was made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate."
67222|NCT02157168|O2|Outcome|Intervention Group (IG1)|"Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.~The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it."
67223|NCT02157168|O1|Outcome|Control Group (CG)|Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker. Those not invited constituted the usual care control group.
67224|NCT02157168|O3|Outcome|Intervention Group (IG2)|"Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.~The intervention group was made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate."
67225|NCT02157168|O2|Outcome|Intervention Group (IG1)|"Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.~The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it."
67226|NCT02157168|O1|Outcome|Control Group (CG)|Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker. Those not invited constituted the usual care control group.
67227|NCT02157168|O3|Outcome|Intervention Group (IG2)|"Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.~The intervention group was made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate."
67228|NCT02157168|O2|Outcome|Intervention Group (IG1)|"Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.~The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it."
67229|NCT02157168|O1|Outcome|Control Group (CG)|Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker. Those not invited constituted the usual care control group.
67230|NCT02157168|E3|Reported Event|Intervention Group (IG2)|"Each month all newly enrolled female health plan members will have an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.~The intervention group will be made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate."
67231|NCT02157168|E2|Reported Event|Intervention Group (IG1)|"Each month all newly enrolled female health plan members will have an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.~The intervention group will be made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it."
67232|NCT02157168|E1|Reported Event|Control Group (CG)|Each month all newly enrolled female health plan members will have an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker. Those not invited will constitute the usual care control group.
67242|NCT02157103|B1|Baseline|Bevacizumab|"Cycle 1 (each cycle is 3 weeks): Bevacizumab 25 mg in 1 ml subcutaneously daily.~Bevacizumab 25 mg in 1 ml subcutaneously daily: Bevacizumab delivered by subcutaneous injection instead of intravenous infusion."
67243|NCT02157103|P1|Participant Flow|Bevacizumab|"Cycle 1 (each cycle is 3 weeks): Bevacizumab 25 mg in 1 ml subcutaneously daily.~Bevacizumab 25 mg in 1 ml subcutaneously daily: Bevacizumab delivered by subcutaneous injection instead of intravenous infusion."
67244|NCT02157103|O1|Outcome|Bevacizumab|"Cycle 1 (each cycle is 3 weeks): Bevacizumab 25 mg in 1 ml subcutaneously daily.~Bevacizumab 25 mg in 1 ml subcutaneously daily: Bevacizumab delivered by subcutaneous injection instead of intravenous infusion."
67245|NCT02157103|O1|Outcome|Bevacizumab|"Cycle 1 (each cycle is 3 weeks): Bevacizumab 25 mg in 1 ml subcutaneously daily.~Bevacizumab 25 mg in 1 ml subcutaneously daily: Bevacizumab delivered by subcutaneous injection instead of intravenous infusion."
67246|NCT02157103|O1|Outcome|Bevacizumab|"Cycle 1 (each cycle is 3 weeks): Bevacizumab 25 mg in 1 ml subcutaneously daily.~Bevacizumab 25 mg in 1 ml subcutaneously daily: Bevacizumab delivered by subcutaneous injection instead of intravenous infusion."
67247|NCT02157103|E1|Reported Event|Bevacizumab|"Cycle 1 (each cycle is 3 weeks): Bevacizumab 25 mg in 1 ml subcutaneously daily.~Bevacizumab 25 mg in 1 ml subcutaneously daily: Bevacizumab delivered by subcutaneous injection instead of intravenous infusion."
67248|NCT02156466|B6|Baseline|Total|Total of all reporting groups
67249|NCT02156466|B5|Baseline|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67250|NCT02156466|B4|Baseline|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67251|NCT02156466|B3|Baseline|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67252|NCT02156466|B2|Baseline|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67253|NCT02156466|B1|Baseline|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67254|NCT02156466|P5|Participant Flow|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67255|NCT02156466|P4|Participant Flow|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67256|NCT02156466|P3|Participant Flow|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67257|NCT02156466|P2|Participant Flow|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67258|NCT02156466|P1|Participant Flow|MSB0010841 30 mg|MSB0010841 (Anti-Interleukin [IL]-17A/F Nanobody) was administered at a dose of 30 milligram (mg) as subcutaneous (SC) injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67259|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67260|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67261|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67262|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67263|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67264|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67265|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67266|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67267|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67268|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67269|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week for a total duration of 6 weeks.
67270|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week for a total duration of 6 weeks.
67271|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week for a total duration of 6 weeks.
67272|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week for a total duration of 6 weeks.
67273|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 was administered at a dose of 30 mg as SC injection every other week for a total duration of 6 weeks.
67274|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67275|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67276|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67594|NCT02155335|B1|Baseline|All Treated Participants|All participants who received at least 1 injection from either prefilled syringe or Smartject
67277|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67278|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67279|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67280|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67281|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67282|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67283|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67284|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67285|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67286|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67287|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67288|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67289|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67290|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67291|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67292|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67293|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67294|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67295|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67296|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67297|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67298|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67299|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67300|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67301|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67302|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67303|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67304|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67305|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67306|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67307|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67308|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67309|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67310|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67311|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67312|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67313|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67314|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67315|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67316|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67317|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67318|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67319|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67320|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67321|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67322|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67323|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67324|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67325|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67326|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67327|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67328|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67329|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67330|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67331|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67332|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67333|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67334|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67335|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67336|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67337|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67338|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67339|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67340|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67341|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67342|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67343|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67344|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67345|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67346|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67347|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67348|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67349|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67350|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67351|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67352|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67353|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67354|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67355|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67356|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67357|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67358|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67359|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67360|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67361|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67362|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67363|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67364|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67365|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67366|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67367|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67368|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67369|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67370|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67371|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67372|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67373|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67374|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67375|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67376|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67377|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67378|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67379|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67380|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67381|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67382|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67383|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67384|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67385|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67386|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67387|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67388|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67389|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67390|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67391|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67392|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67393|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67394|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67395|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67396|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67397|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67398|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67399|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67400|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67401|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67402|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67403|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67404|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67405|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67406|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67407|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67408|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67409|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67410|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67411|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67412|NCT02156466|O1|Outcome|ADA Positive Subjects|All subjects who received placebo or MSB0010841 (30 mg, 60 mg, 90 mg or 240 mg) and had positive ADA titers before and/or after study drug administration.
67413|NCT02156466|O1|Outcome|ADA Positive Subjects|All subjects who received placebo or MSB0010841 (30 mg, 60 mg, 90 mg or 240 mg) and had positive ADA titers before and/or after study drug administration.
67414|NCT02156466|O2|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67415|NCT02156466|O1|Outcome|MSB0010841 Combined|All subjects who received MSB0010841 (Anti-IL-17A/F Nanobody) at a dose of 30 mg, 60 mg, 120 mg or 240 mg as subcutaneous (SC) injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks
67416|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67417|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67418|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67419|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67643|NCT02154425|B1|Baseline|Mothers (SS)|This arm consisted of all participating mothers who had received at least 1 dose of Certolizumab Pegol (CZP).
67420|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67421|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67422|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67423|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67424|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67425|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67426|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67427|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67428|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67429|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67430|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67431|NCT02156466|E5|Reported Event|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67432|NCT02156466|E4|Reported Event|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67433|NCT02156466|E3|Reported Event|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67434|NCT02156466|E2|Reported Event|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67435|NCT02156466|E1|Reported Event|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
67436|NCT02156271|B3|Baseline|Total|Total of all reporting groups
67437|NCT02156271|B2|Baseline|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
67438|NCT02156271|B1|Baseline|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
67439|NCT02156271|P2|Participant Flow|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
67440|NCT02156271|P1|Participant Flow|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
67441|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
67442|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
67443|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
67444|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
67445|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
67446|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
67447|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
67448|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
67449|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
67450|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
67451|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
67452|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
67453|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
67454|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
67455|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
67456|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
67457|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
67458|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
67459|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
67460|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
67461|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
67462|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
67463|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
67464|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
67465|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
67466|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
67467|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
67468|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
67469|NCT02156271|E2|Reported Event|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
67470|NCT02156271|E1|Reported Event|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
67471|NCT02156167|B1|Baseline|CP810|Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked)
67472|NCT02156167|P1|Participant Flow|CP810|Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked)
67473|NCT02156167|O1|Outcome|CP810|Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked)
67474|NCT02156167|E1|Reported Event|CP810|Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked)
67475|NCT02155985|B4|Baseline|Total|Total of all reporting groups
67476|NCT02155985|B3|Baseline|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
67477|NCT02155985|B2|Baseline|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67478|NCT02155985|B1|Baseline|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67479|NCT02155985|P3|Participant Flow|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
67480|NCT02155985|P2|Participant Flow|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67481|NCT02155985|P1|Participant Flow|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67482|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
67483|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67484|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67485|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
67486|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67487|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67488|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
67489|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67644|NCT02154425|P1|Participant Flow|Mothers (SS)|This arm consisted of all participating mothers who had received at least 1 dose of Certolizumab Pegol (CZP).
67490|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67491|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
67492|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67493|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67494|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
67495|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67496|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67497|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
67498|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67499|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67500|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
67501|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67502|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67503|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
67504|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67505|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67506|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
67507|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67508|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67509|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
67510|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67511|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67645|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
67512|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
67513|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67514|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67515|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
67516|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67517|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67518|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
67519|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67520|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67521|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
67522|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67523|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67524|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
67525|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67526|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67527|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
67528|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67529|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67530|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
67531|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67532|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67533|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
67646|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
67534|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67535|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67536|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
67537|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67538|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67539|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
67540|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67541|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67542|NCT02155985|E3|Reported Event|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
67543|NCT02155985|E2|Reported Event|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67544|NCT02155985|E1|Reported Event|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
67545|NCT02155881|B3|Baseline|Total|Total of all reporting groups
67546|NCT02155881|B2|Baseline|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
67547|NCT02155881|B1|Baseline|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
67548|NCT02155881|P2|Participant Flow|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
67549|NCT02155881|P1|Participant Flow|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
67550|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
67551|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
67552|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
67553|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
67554|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
67555|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
67556|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
67557|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
67558|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
67559|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
67560|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
67561|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
67562|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
67563|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
67564|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
67565|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
67566|NCT02155881|E2|Reported Event|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
67567|NCT02155881|E1|Reported Event|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
67568|NCT02155543|B8|Baseline|Total|Total of all reporting groups
67704|NCT02154139|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
67569|NCT02155543|B7|Baseline|AGN-223575 Vehicle BID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle twice daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
67570|NCT02155543|B6|Baseline|AGN-223575 Vehicle TID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle three times daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
67571|NCT02155543|B5|Baseline|Cohort 1: AGN-223575 Form A/Vehicle|One drop of AGN-223575 Formulation A in the study eye and one drop of AGN-223575 vehicle in the other eye on day 1, followed by one drop of AGN-223575 Formulation A twice daily in the study eye and 1 drop of AGN-223575 vehicle in the other eye twice daily for 6 days.
67572|NCT02155543|B4|Baseline|Cohort 2: AGN-223575 Formulation A BID|One drop of AGN-223575 Formulation A in both eyes on day 1, followed by one drop of AGN-223575 Formulation A twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation A in both eyes on day 15.
67573|NCT02155543|B3|Baseline|Cohort 3: AGN-223575 Formulation B BID|One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15.
67574|NCT02155543|B2|Baseline|Cohort 4: AGN-223575 Formulation C BID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
67575|NCT02155543|B1|Baseline|Cohort 5: AGN-223575 Formulation C TID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C three times daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
67576|NCT02155543|P7|Participant Flow|AGN-223575 Vehicle BID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle twice daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
67577|NCT02155543|P6|Participant Flow|AGN-223575 Vehicle TID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle three times daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
67578|NCT02155543|P5|Participant Flow|Cohort 1: AGN-223575 Form A/Vehicle|One drop of AGN-223575 Formulation A in the study eye and one drop of AGN-223575 vehicle in the other eye on day 1, followed by one drop of AGN-223575 Formulation A twice daily in the study eye and 1 drop of AGN-223575 vehicle in the other eye twice daily for 6 days.
67579|NCT02155543|P4|Participant Flow|Cohort 2: AGN-223575 Formulation A BID|One drop of AGN-223575 Formulation A in both eyes on day 1, followed by one drop of AGN-223575 Formulation A twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation A in both eyes on day 15.
67580|NCT02155543|P3|Participant Flow|Cohort 3: AGN-223575 Formulation B BID|One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15.
67581|NCT02155543|P2|Participant Flow|Cohort 4: AGN-223575 Formulation C BID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
67582|NCT02155543|P1|Participant Flow|Cohort 5: AGN-223575 Formulation C TID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C three times daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
67583|NCT02155543|O4|Outcome|Cohort 2: AGN-223575 Formulation A BID|One drop of AGN-223575 Formulation A in both eyes on day 1, followed by one drop of AGN-223575 Formulation A twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation A in both eyes on day 15.
67584|NCT02155543|O3|Outcome|Cohort 3: AGN-223575 Formulation B BID|One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15.
67585|NCT02155543|O2|Outcome|Cohort 4: AGN-223575 Formulation C BID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
67586|NCT02155543|O1|Outcome|Cohort 5: AGN-223575 Formulation C TID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C three times daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
67587|NCT02155543|E7|Reported Event|Cohort 1: AGN-223575 Form A/Vehicle|One drop of AGN-223575 Formulation A in the study eye and one drop of AGN-223575 vehicle in the other eye on day 1, followed by one drop of AGN-223575 Formulation A twice daily in the study eye and 1 drop of AGN-223575 vehicle in the other eye twice daily for 6 days.
67588|NCT02155543|E6|Reported Event|AGN-223575 Vehicle BID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle twice daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
67589|NCT02155543|E5|Reported Event|AGN-223575 Vehicle TID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle three times daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
67590|NCT02155543|E4|Reported Event|Cohort 2: AGN-223575 Formulation A BID|One drop of AGN-223575 Formulation A in both eyes on day 1, followed by one drop of AGN-223575 Formulation A twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation A in both eyes on day 15.
67591|NCT02155543|E3|Reported Event|Cohort 3: AGN-223575 Formulation B BID|One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15.
67592|NCT02155543|E2|Reported Event|Cohort 4: AGN-223575 Formulation C BID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
67593|NCT02155543|E1|Reported Event|Cohort 5: AGN-223575 Formulation C TID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C three times daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
67825|NCT02153398|B4|Baseline|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
67595|NCT02155335|P2|Participant Flow|Smartject™ Device→ Prefilled Syringe|Golimumab 50 mg supplied in a Smartject administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant than is administered Golimumab 50 mg supplied a prefilled syringe 2 times, first by the physician and then by the participant. Participants receive a total of 200 mg of golimumbab.
67596|NCT02155335|P1|Participant Flow|Prefilled Syringe→Smartject™ Device|Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant than is administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Participants receive a total of 200 mg of golimumbab.
67597|NCT02155335|O1|Outcome|Per Protocl Set (PPS)|All enrolled participants who met all inclusion and none of the exclusion criteria, received all four injections of golimumab according to the protocol, and completed the device preference questionnaire.
67598|NCT02155335|O1|Outcome|Per Protocl Set (PPS)|All enrolled participants who met all inclusion and none of the exclusion criteria, received all four injections of golimumab according to the protocol, and completed the device preference questionnaire.
67599|NCT02155335|E1|Reported Event|All Treated Participants|All participants who received at least 1 injection from either prefilled syringe or Smartject
67600|NCT02155322|B1|Baseline|PEG-IFN|Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).
67601|NCT02155322|P1|Participant Flow|PEG-IFN|Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).
67602|NCT02155322|O1|Outcome|PEG-IFN|Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).
67603|NCT02155322|O1|Outcome|PEG-IFN|Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).
67604|NCT02155322|E1|Reported Event|PEG-IFN|Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).
67605|NCT02155309|B3|Baseline|Total|Total of all reporting groups
67606|NCT02155309|B2|Baseline|Efficacy: All Study Participants (Crossover, Double-Blind)|Double-blind, placebo-controlled, cross-over design. Study medications (0.2 mg of intranasal scopolamine and 0.2 mg of intranasal placebo) were randomized, blinded, and delivered in identical containers. Each subject participated in two sessions separated by minimum of one week, each session identical except for contents of intranasal spray. Order of treatment and placebo administration randomized. Baseline vitals, blood draw, and cognitive testing applied prior to dosage. Approximately 40 minutes post-dose, subjects experience mechanical rotation via Coriolis cross-coupling in a stairwise progression until subject reported either full minute of unabated stomach awareness, or the maximum rotation of 40 rpm obtained. Blood draws, vitals collection, cognitive testing and subjective fatigue collected for approximately three hours post-rotation.
67607|NCT02155309|B1|Baseline|PK: Scopolamine Only, Open-label|Baseline vitals, blood draw, and cognitive testing applied. Subjects then received one dose of 0.2 mg intranasal scopolamine (0.1 mg per nostril). No placebo or efficacy. Blood draws, vitals collection, cognitive testing, and subjective fatigue collected for approximately eight hours post-dose.
67608|NCT02155309|P3|Participant Flow|Efficacy: Placebo, Then Scopolamine|Subjects received one dose of 0.2 mg intranasal placebo (0.1 mg per nostril) for the first of two Efficacy sessions, and then one dose of 0.2 mg intranasal scopolamine (0.1 mg per nostril) for the second Efficacy session. A minimum of one week separated the two sessions. Each session was identical except for contents of intranasal spray. Baseline vitals, blood draw, and cognitive testing applied prior to dosage. Approximately 40 minutes post-dose, subjects experience mechanical rotation via Coriolis cross-coupling in a stairwise progression until subject reported either full minute of unabated stomach awareness, or the maximum rotation of 40 rpm obtained. Blood draws, vitals collection, cognitive testing and subjective fatigue collected for approximately three hours post-rotation.
67609|NCT02155309|P2|Participant Flow|Efficacy: Scopolamine, Then Placebo|Subjects received one dose of 0.2 mg intranasal scopolamine (0.1 mg per nostril) for the first of two Efficacy sessions, and then one dose of 0.2 mg placebo intranasal (0.1 mg per nostril) for the second Efficacy session. A minimum of one week separated the two sessions. Each session was identical except for contents of intranasal spray. Baseline vitals, blood draw, and cognitive testing applied prior to dosage. Approximately 40 minutes post-dose, subjects experience mechanical rotation via Coriolis cross-coupling in a stairwise progression until subject reported either full minute of unabated stomach awareness, or the maximum rotation of 40 rpm obtained. Blood draws, vitals collection, cognitive testing and subjective fatigue collected for approximately three hours post-rotation.
67610|NCT02155309|P1|Participant Flow|PK: Scopolamine Only, Open-label|Baseline vitals, blood draw, and cognitive testing applied. Subjects then received one dose of 0.2 mg intranasal scopolamine (0.1 mg per nostril). No placebo or efficacy. Blood draws, vitals collection, cognitive testing, and subjective fatigue collected for approximately eight hours post-dose.
67611|NCT02155309|O2|Outcome|Efficacy: Scopolamine and Placebo (Crossover, Double-blind)|Subjects received either one dose of 0.2 mg intranasal scopolamine (0.1 mg per nostril) or one dose of 0.2 mg placebo intranasal (0.1 mg per nostril) for two Efficacy sessions. Each session identical except for contents of intranasal spray. Baseline vitals, blood draw, and cognitive testing applied prior to dosage. Approximately 40 minutes post-dose, subjects experience mechanical rotation via Coriolis cross-coupling in a stairwise progression until subject reported either full minute of unabated stomach awareness, or the maximum rotation of 40 rpm obtained. Blood draws, vitals collection, cognitive testing and subjective fatigue collected for approximately three hours post-rotation. One week minimum separated the two Efficacy sessions.
67612|NCT02155309|O1|Outcome|PK: Scopolamine Only, Open-label|Baseline vitals, blood draw, and cognitive testing applied. Subjects then received one dose of 0.2 mg intranasal scopolamine (0.1 mg per nostril). No placebo or efficacy. Blood draws, vitals collection, cognitive testing, and subjective fatigue collected for approximately eight hours post-dose.
67613|NCT02155309|E3|Reported Event|Efficacy: Placebo (Crossover, Double-blind)|Subjects received either one dose of 0.2 mg intranasal scopolamine (0.1 mg per nostril) or one dose of 0.2 mg placebo intranasal (0.1 mg per nostril) for two Efficacy sessions. Each session identical except for contents of intranasal spray. Baseline vitals, blood draw, and cognitive testing applied prior to dosage. Approximately 40 minutes post-dose, subjects experience mechanical rotation via Coriolis cross-coupling in a stairwise progression until subject reported either full minute of unabated stomach awareness, or the maximum rotation of 40 rpm obtained. Blood draws, vitals collection, cognitive testing and subjective fatigue collected for approximately three hours post-rotation. One week minimum separated the two Efficacy sessions.
67614|NCT02155309|E2|Reported Event|Efficacy: Scopolamine (Crossover, Double-blind)|Subjects received either one dose of 0.2 mg intranasal scopolamine (0.1 mg per nostril) or one dose of 0.2 mg placebo intranasal (0.1 mg per nostril) for two Efficacy sessions. Each session identical except for contents of intranasal spray. Baseline vitals, blood draw, and cognitive testing applied prior to dosage. Approximately 40 minutes post-dose, subjects experience mechanical rotation via Coriolis cross-coupling in a stairwise progression until subject reported either full minute of unabated stomach awareness, or the maximum rotation of 40 rpm obtained. Blood draws, vitals collection, cognitive testing and subjective fatigue collected for approximately three hours post-rotation. One week minimum separated the two Efficacy sessions.
67615|NCT02155309|E1|Reported Event|PK: Scopolamine Only, Open-label|Baseline vitals, blood draw, and cognitive testing applied. Subjects then received one dose of 0.2 mg intranasal scopolamine (0.1 mg per nostril). No placebo or efficacy. Blood draws, vitals collection, cognitive testing, and subjective fatigue collected for approximately eight hours post-dose.
67616|NCT02155283|B1|Baseline|Treatment Continuous Passive Motion|"Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)~Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day"
67617|NCT02155283|P1|Participant Flow|Treatment Continuous Passive Motion|"Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)~Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day"
67618|NCT02155283|O1|Outcome|Treatment Continuous Passive Motion|"Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)~Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day"
67619|NCT02155283|O1|Outcome|Treatment Continuous Passive Motion|"Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)~Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day"
67620|NCT02155283|E1|Reported Event|Treatment Continuous Passive Motion|"Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)~Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day"
67621|NCT02155010|B3|Baseline|Total|Total of all reporting groups
67622|NCT02155010|B2|Baseline|After Spinal Anesthesia|"IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine~Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine"
67623|NCT02155010|B1|Baseline|Before Spinal Anesthesia|"IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine~Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine"
67624|NCT02155010|P2|Participant Flow|Dexmedetomidine After Bupivacaine|"IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine~Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine"
67625|NCT02155010|P1|Participant Flow|Dexmedetomidine Before Bupivacaine|"IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine~Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine"
67626|NCT02155010|O2|Outcome|After Spinal Anesthesia|"IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine~Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine"
67627|NCT02155010|O1|Outcome|Before Spinal Anesthesia|"IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine~Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine"
67628|NCT02155010|O2|Outcome|After Spinal Anesthesia|"IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine~Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine"
67629|NCT02155010|O1|Outcome|Before Spinal Anesthesia|"IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine~Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine"
67630|NCT02155010|E2|Reported Event|After Spinal Anesthesia|"IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine~Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine"
67631|NCT02155010|E1|Reported Event|Before Spinal Anesthesia|"IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine~Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine"
67632|NCT02154906|B3|Baseline|Total|Total of all reporting groups
67633|NCT02154906|B2|Baseline|Autologous Platelet Rich Fibrin|"autologous platelet rich fibrin used to graft intrabony defect~autologous platelet rich fibrin"
67634|NCT02154906|B1|Baseline|DFDBA|"DFDBA used to graft intrabony defect~DFDBA"
67635|NCT02154906|P2|Participant Flow|Autologous Platelet Rich Fibrin|"autologous platelet rich fibrin used to graft intrabony defect~autologous platelet rich fibrin"
67636|NCT02154906|P1|Participant Flow|DFDBA|"DFDBA used to graft intrabony defect~DFDBA"
67637|NCT02154906|O2|Outcome|Autologous Platelet Rich Fibrin|"autologous platelet rich fibrin used to graft intrabony defect~autologous platelet rich fibrin"
67638|NCT02154906|O1|Outcome|DFDBA|"DFDBA used to graft intrabony defect~DFDBA"
67639|NCT02154906|O2|Outcome|Autologous Platelet Rich Fibrin|"autologous platelet rich fibrin used to graft intrabony defect~autologous platelet rich fibrin"
67640|NCT02154906|O1|Outcome|DFDBA|"DFDBA used to graft intrabony defect~DFDBA"
67641|NCT02154906|E2|Reported Event|Autologous Platelet Rich Fibrin|"autologous platelet rich fibrin used to graft intrabony defect~autologous platelet rich fibrin"
67642|NCT02154906|E1|Reported Event|DFDBA|"DFDBA used to graft intrabony defect~DFDBA"
67826|NCT02153398|B3|Baseline|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
67647|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
67648|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
67649|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
67650|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
67651|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
67652|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
67653|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
67654|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
67655|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
67656|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
67657|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
67658|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
67659|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
67660|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
67661|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
67662|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
67663|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
67664|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
67665|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
67666|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
67667|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
67668|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
67669|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
67670|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
67671|NCT02154425|E2|Reported Event|SS-I|This arm consisted of all infants of mothers in the SS-M.
67672|NCT02154425|E1|Reported Event|SS-M|This arm consisted of all participating mothers who had received at least 1 dose of Certolizumab Pegol (CZP).
67673|NCT02154386|B3|Baseline|Total|Total of all reporting groups
67674|NCT02154386|B2|Baseline|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
67705|NCT02154139|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
67675|NCT02154386|B1|Baseline|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
67676|NCT02154386|P2|Participant Flow|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
67677|NCT02154386|P1|Participant Flow|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
67678|NCT02154386|O2|Outcome|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
67679|NCT02154386|O1|Outcome|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
67680|NCT02154386|O2|Outcome|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
67681|NCT02154386|O1|Outcome|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
67682|NCT02154386|O2|Outcome|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
67683|NCT02154386|O1|Outcome|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
67684|NCT02154386|E2|Reported Event|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
67685|NCT02154386|E1|Reported Event|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
67686|NCT02154243|B4|Baseline|Total|Total of all reporting groups
67687|NCT02154243|B3|Baseline|Control (no Intervention)|Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.
67688|NCT02154243|B2|Baseline|Intravenous Fluid Bolus|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV>=15 will be given intravenous fluid bolus, 15 cc/kg, once.~Intravenous fluid bolus: 15 cc/kg, once, on day of surgery after first physical therapy session"
67689|NCT02154243|B1|Baseline|Midodrine|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV<15 will be given oral midodrine, 10 mg, once.~Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session"
67690|NCT02154243|P3|Participant Flow|Control (no Intervention)|Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.
67691|NCT02154243|P2|Participant Flow|Intravenous Fluid Bolus|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV>=15 will be given intravenous fluid bolus, 15 cc/kg, once.~Intravenous fluid bolus: 15 cc/kg, once, on day of surgery after first physical therapy session"
67692|NCT02154243|P1|Participant Flow|Midodrine|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV<15 will be given oral midodrine, 10 mg, once.~Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session"
67693|NCT02154243|O3|Outcome|Control (no Intervention)|Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.
67694|NCT02154243|O2|Outcome|Intravenous Fluid Bolus|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV>=15 will be given intravenous fluid bolus, 15 cc/kg, once.~Intravenous fluid bolus: 15 cc/kg, once, on day of surgery after first physical therapy session"
67695|NCT02154243|O1|Outcome|Midodrine|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV<15 will be given oral midodrine, 10 mg, once.~Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session"
67696|NCT02154243|O3|Outcome|Control (no Intervention)|Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.
67697|NCT02154243|O2|Outcome|Intravenous Fluid Bolus|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV>=15 will be given intravenous fluid bolus, 15 cc/kg, once.~Intravenous fluid bolus: 15 cc/kg, once, on day of surgery after first physical therapy session"
67698|NCT02154243|O1|Outcome|Midodrine|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV<15 will be given oral midodrine, 10 mg, once.~Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session"
67699|NCT02154243|E3|Reported Event|Control (no Intervention)|Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.
67700|NCT02154243|E2|Reported Event|Intravenous Fluid Bolus|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV>=15 will be given intravenous fluid bolus, 15 cc/kg, once.~Intravenous fluid bolus: 15 cc/kg, once, on day of surgery after first physical therapy session"
67701|NCT02154243|E1|Reported Event|Midodrine|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV<15 will be given oral midodrine, 10 mg, once.~Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session"
67702|NCT02154139|B1|Baseline|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
67703|NCT02154139|P1|Participant Flow|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
67706|NCT02154139|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
67707|NCT02154139|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
67708|NCT02154139|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
67709|NCT02154139|E1|Reported Event|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
67710|NCT02154087|B1|Baseline|HP802-247|"HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle~HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution & acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first"
67711|NCT02154087|P1|Participant Flow|HP802-247|"HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle~HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution & acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first"
67712|NCT02154087|O1|Outcome|HP802-247|"HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle~HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution & acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first"
67713|NCT02154087|E1|Reported Event|HP802-247|"HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle~HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution & acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first"
67714|NCT02154048|B4|Baseline|Total|Total of all reporting groups
67715|NCT02154048|B3|Baseline|Additive Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.~Ropivacaine + Dexamethasone + Placebo"
67716|NCT02154048|B2|Baseline|Local Anesthetic (LA) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.~Ropivacaine + Placebo"
67717|NCT02154048|B1|Baseline|Intravenous (IV) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.~Ropivacaine + Dexamethasone"
67718|NCT02154048|P3|Participant Flow|Additive Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.~Ropivacaine + Dexamethasone + Placebo"
67719|NCT02154048|P2|Participant Flow|Local Anesthetic (LA) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.~Ropivacaine + Placebo"
67720|NCT02154048|P1|Participant Flow|Intravenous (IV) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.~Ropivacaine + Dexamethasone"
67721|NCT02154048|O3|Outcome|Additive Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.~Ropivacaine + Dexamethasone + Placebo"
67722|NCT02154048|O2|Outcome|Intravenous (IV) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.~Ropivacaine + Dexamethasone"
67723|NCT02154048|O1|Outcome|Local Anesthetic (LA) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.~Ropivacaine + Placebo"
67724|NCT02154048|E3|Reported Event|Additive Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.~Ropivacaine + Dexamethasone + Placebo"
67725|NCT02154048|E2|Reported Event|Local Anesthetic (LA) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.~Ropivacaine + Placebo"
67726|NCT02154048|E1|Reported Event|Intravenous (IV) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.~Ropivacaine + Dexamethasone"
67727|NCT02153827|B3|Baseline|Total|Total of all reporting groups
67728|NCT02153827|B2|Baseline|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
67729|NCT02153827|B1|Baseline|Eccentric External Rotator Training|"Eccentric Shoulder External Rotator Training~Eccentric Shoulder External Rotator Training"
67730|NCT02153827|P2|Participant Flow|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
67731|NCT02153827|P1|Participant Flow|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
67732|NCT02153827|O2|Outcome|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
67733|NCT02153827|O1|Outcome|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
67734|NCT02153827|O2|Outcome|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
67735|NCT02153827|O1|Outcome|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
67736|NCT02153827|O2|Outcome|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
67737|NCT02153827|O1|Outcome|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
67738|NCT02153827|O2|Outcome|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
67739|NCT02153827|O1|Outcome|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
67740|NCT02153827|O2|Outcome|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
67741|NCT02153827|O1|Outcome|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
67742|NCT02153827|E2|Reported Event|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
67743|NCT02153827|E1|Reported Event|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
67744|NCT02153788|B3|Baseline|Total|Total of all reporting groups
67745|NCT02153788|B2|Baseline|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
67746|NCT02153788|B1|Baseline|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
67747|NCT02153788|P2|Participant Flow|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
67748|NCT02153788|P1|Participant Flow|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
67749|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
67750|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
67751|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
67752|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
67753|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
67754|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
67755|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
67756|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
67757|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
67758|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
67759|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
67760|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
67785|NCT02153489|P2|Participant Flow|Sequence B|Placebo - Aclidinium 400 μg
67786|NCT02153489|P1|Participant Flow|Sequence A|Aclidinium 400 μg - Placebo
67787|NCT02153489|O2|Outcome|Placebo|Placebo BID
67761|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
67762|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
67763|NCT02153788|E2|Reported Event|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
67764|NCT02153788|E1|Reported Event|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
67765|NCT02153736|B3|Baseline|Total|Total of all reporting groups
67766|NCT02153736|B2|Baseline|SPEEDI Intervention|"This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.~SPEEDI Intervention: Behavioral intervention provided through a collaboration between the mother of enrolled subjects and a physical therapist. Intervention starts in the Neonatal Intensive Care Unit and continues after discharge. SPEEDI includes both parent education and developmental activities."
67767|NCT02153736|B1|Baseline|Usual Care Group|This group of subjects will receive usual care provided in the medial system and community.
67768|NCT02153736|P2|Participant Flow|SPEEDI Intervention|"This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.~SPEEDI Intervention: Behavioral intervention provided through a collaboration between the mother of enrolled subjects and a physical therapist. Intervention starts in the Neonatal Intensive Care Unit and continues after discharge. SPEEDI includes both parent education and developmental activities."
67769|NCT02153736|P1|Participant Flow|Usual Care Group|This group of subjects will receive usual care provided in the medial system and community.
67770|NCT02153736|O2|Outcome|SPEEDI Intervention|"This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.~SPEEDI Intervention: Behavioral intervention provided through a collaboration between the mother of enrolled subjects and a physical therapist. Intervention starts in the Neonatal Intensive Care Unit and continues after discharge. SPEEDI includes both parent education and developmental activities."
67771|NCT02153736|O1|Outcome|Usual Care Group|This group of subjects will receive usual care provided in the medial system and community.
67772|NCT02153736|O2|Outcome|SPEEDI Intervention|"This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.~SPEEDI Intervention: Behavioral intervention provided through a collaboration between the mother of enrolled subjects and a physical therapist. Intervention starts in the Neonatal Intensive Care Unit and continues after discharge. SPEEDI includes both parent education and developmental activities."
67773|NCT02153736|O1|Outcome|Usual Care Group|This group of subjects will receive usual care provided in the medial system and community.
67774|NCT02153736|O2|Outcome|SPEEDI Intervention|"This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.~SPEEDI Intervention: Behavioral intervention provided through a collaboration between the mother of enrolled subjects and a physical therapist. Intervention starts in the Neonatal Intensive Care Unit and continues after discharge. SPEEDI includes both parent education and developmental activities."
67775|NCT02153736|O1|Outcome|Usual Care Group|This group of subjects will receive usual care provided in the medial system and community.
67776|NCT02153736|O2|Outcome|SPEEDI Intervention|"This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.~SPEEDI Intervention: Behavioral intervention provided through a collaboration between the mother of enrolled subjects and a physical therapist. Intervention starts in the Neonatal Intensive Care Unit and continues after discharge. SPEEDI includes both parent education and developmental activities."
67777|NCT02153736|O1|Outcome|Usual Care Group|This group of subjects will receive usual care provided in the medial system and community.
67778|NCT02153736|O2|Outcome|SPEEDI Intervention|"This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.~SPEEDI Intervention: Behavioral intervention provided through a collaboration between the mother of enrolled subjects and a physical therapist. Intervention starts in the Neonatal Intensive Care Unit and continues after discharge. SPEEDI includes both parent education and developmental activities."
67779|NCT02153736|O1|Outcome|Usual Care Group|This group of subjects will receive usual care provided in the medial system and community.
67780|NCT02153736|O2|Outcome|SPEEDI Intervention|"This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.~SPEEDI Intervention: Behavioral intervention provided through a collaboration between the mother of enrolled subjects and a physical therapist. Intervention starts in the Neonatal Intensive Care Unit and continues after discharge. SPEEDI includes both parent education and developmental activities."
67781|NCT02153736|O1|Outcome|Usual Care Group|This group of subjects will receive usual care provided in the medial system and community.
67782|NCT02153736|E2|Reported Event|SPEEDI Intervention|"This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.~SPEEDI Intervention: Behavioral intervention provided through a collaboration between the mother of enrolled subjects and a physical therapist. Intervention starts in the Neonatal Intensive Care Unit and continues after discharge. SPEEDI includes both parent education and developmental activities."
67783|NCT02153736|E1|Reported Event|Usual Care Group|This group of subjects will receive usual care provided in the medial system and community.
67784|NCT02153489|B1|Baseline|Overall Study|All patients participating in the crossover study
67827|NCT02153398|B2|Baseline|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
67828|NCT02153398|B1|Baseline|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
67829|NCT02153398|P5|Participant Flow|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
67830|NCT02153398|P4|Participant Flow|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
67831|NCT02153398|P3|Participant Flow|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
67832|NCT02153398|P2|Participant Flow|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
67833|NCT02153398|P1|Participant Flow|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
67834|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
67835|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
67836|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
67837|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
67838|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
67839|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
67840|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
67841|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
67842|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
67843|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
67844|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
67845|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
67846|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
67847|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
67848|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
67849|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
67850|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
67851|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
67852|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
67853|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
67854|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
67855|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
67856|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
67857|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
67858|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
67859|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
67860|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
67861|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
67862|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
67863|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
67864|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
67865|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
67866|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
67867|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
67868|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
67869|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
67870|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
67871|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
67872|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
67873|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
67874|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
67875|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
67876|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
67877|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
67878|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
67879|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
67880|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
67881|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
67882|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
67883|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
67884|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
67885|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
67886|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
67887|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
67888|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
67889|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
67890|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
67891|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
67892|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
67893|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
67894|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
67895|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
67896|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
67897|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
67898|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
67899|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
67900|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
67901|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
67902|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
67903|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
67904|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
67905|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
67906|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
67907|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
67908|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
67909|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
67910|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
67911|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
67912|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
67913|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
67914|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
67915|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
67916|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
67917|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
67918|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
67919|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
67920|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
67921|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
67922|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
67923|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
67924|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
67925|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
67926|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
67927|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
67928|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
67929|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
67930|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
67931|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
67932|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
67933|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
67934|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
67935|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
67936|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
67937|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
67938|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
67939|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
67940|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
67941|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
67942|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
67943|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
67944|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
67945|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
67946|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
67947|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
67948|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
67949|NCT02153398|E5|Reported Event|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
67950|NCT02153398|E4|Reported Event|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
67951|NCT02153398|E3|Reported Event|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
67952|NCT02153398|E2|Reported Event|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
67953|NCT02153398|E1|Reported Event|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
67954|NCT02153346|B1|Baseline|BD-Asthma/RESP|Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
68009|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
67955|NCT02153346|P1|Participant Flow|BD-Asthma/RESP|Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
67956|NCT02153346|O1|Outcome|BD-Asthma/RESP|Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
67957|NCT02153346|O1|Outcome|BD-Asthma/RESP|Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
67958|NCT02153346|O1|Outcome|BD-Asthma/RESP|Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base. Only participants actively working who completed the questionnaires were included in the analysis of productivity.
67959|NCT02153346|O1|Outcome|BD-Asthma/RESP|Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
67960|NCT02153346|E1|Reported Event|BD-Asthma/RESP|Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
67961|NCT02153099|B8|Baseline|Total|Total of all reporting groups
67962|NCT02153099|B7|Baseline|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
67963|NCT02153099|B6|Baseline|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
67964|NCT02153099|B5|Baseline|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
67965|NCT02153099|B4|Baseline|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
67966|NCT02153099|B3|Baseline|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
67967|NCT02153099|B2|Baseline|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
67968|NCT02153099|B1|Baseline|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
67969|NCT02153099|P7|Participant Flow|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
67970|NCT02153099|P6|Participant Flow|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
67971|NCT02153099|P5|Participant Flow|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
67972|NCT02153099|P4|Participant Flow|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
67973|NCT02153099|P3|Participant Flow|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
67974|NCT02153099|P2|Participant Flow|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
67975|NCT02153099|P1|Participant Flow|Cohort 4: TAK-058 5 mg|TAK-058 (ENV8058) 5 mg, 100 mL oral solution, once on Day 1.
67976|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
67977|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
67978|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
67979|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
67980|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
67981|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
67982|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
67983|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
67984|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
67985|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
67986|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
67987|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
67988|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
67989|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
67990|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
67991|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
67992|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
67993|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
67994|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
67995|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
67996|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
67997|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
67998|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
67999|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
68000|NCT02153099|O7|Outcome|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
68001|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
68002|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
68003|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
68004|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
68005|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
68006|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
68007|NCT02153099|O7|Outcome|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
68008|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
68010|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
68011|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
68012|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
68013|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
68014|NCT02153099|O7|Outcome|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
68015|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
68016|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
68017|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
68018|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
68019|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
68020|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
68021|NCT02153099|E7|Reported Event|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
68022|NCT02153099|E6|Reported Event|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
68023|NCT02153099|E5|Reported Event|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
68024|NCT02153099|E4|Reported Event|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
68025|NCT02153099|E3|Reported Event|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
68026|NCT02153099|E2|Reported Event|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
68027|NCT02153099|E1|Reported Event|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
68028|NCT02153086|B1|Baseline|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
68029|NCT02153086|P1|Participant Flow|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
68030|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
68031|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
68032|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
68033|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
68034|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
68035|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
68036|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
68037|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
68038|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
68039|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
68040|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
68041|NCT02153086|E1|Reported Event|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
68042|NCT02152605|B3|Baseline|Total|Total of all reporting groups
68043|NCT02152605|B2|Baseline|UMEC/VI 62.5/25 mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
68044|NCT02152605|B1|Baseline|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
68045|NCT02152605|P2|Participant Flow|UMEC/VI 62.5/25 mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
68046|NCT02152605|P1|Participant Flow|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
68047|NCT02152605|O2|Outcome|UMEC/VI 62.5/25mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
68048|NCT02152605|O1|Outcome|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
68049|NCT02152605|O2|Outcome|UMEC/VI 62.5/25 mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
68050|NCT02152605|O1|Outcome|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
68051|NCT02152605|O2|Outcome|UMEC/VI 62.5/25 mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
68052|NCT02152605|O1|Outcome|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
68053|NCT02152605|E2|Reported Event|UMEC/VI 62.5/25mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
68054|NCT02152605|E1|Reported Event|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
68055|NCT02152566|B1|Baseline|Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy|"All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.~Nasal High flow therapy device: Nasal high flow therapy via nasal cannula."
68056|NCT02152566|P1|Participant Flow|Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy|"All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.~Nasal High flow therapy device: Nasal high flow therapy via nasal cannula."
68057|NCT02152566|O1|Outcome|Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy|"All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.~Nasal High flow therapy device: Nasal high flow therapy via nasal cannula."
68058|NCT02152566|E1|Reported Event|Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy|"All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.~Nasal High flow therapy device: Nasal high flow therapy via nasal cannula."
68059|NCT02152371|B3|Baseline|Total|Total of all reporting groups
68060|NCT02152371|B2|Baseline|Placebo + Insulin Glargine|Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
68061|NCT02152371|B1|Baseline|Dulaglutide + Insulin Glargine|1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
68062|NCT02152371|P2|Participant Flow|Placebo + Insulin Glargine|Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
68063|NCT02152371|P1|Participant Flow|Dulaglutide + Insulin Glargine|1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
68064|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68065|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68066|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68067|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68068|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68069|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68070|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68071|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68072|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68073|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68074|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68075|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68076|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68077|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68078|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68079|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68080|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68081|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68082|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68083|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68084|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68085|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68086|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68128|NCT02151994|O1|Outcome|Placebo|Placebo : visually matching active medication
68129|NCT02151994|O10|Outcome|2400 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
68130|NCT02151994|O9|Outcome|1600 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
68087|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68088|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68089|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68090|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68091|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68092|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68093|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68094|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68095|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68096|NCT02152371|E2|Reported Event|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68097|NCT02152371|E1|Reported Event|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
68098|NCT02152007|B1|Baseline|Split-body 1% Sirolimus Cream (TD201 1%)|"This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.~1% sirolimus cream (TD201 1%): 1% sirolimus cream (TD201 1%)"
68099|NCT02152007|P1|Participant Flow|Split-body 1% Sirolimus Cream (TD201 1%)|"This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.~1% sirolimus cream (TD201 1%): 1% sirolimus cream (TD201 1%)"
68100|NCT02152007|O2|Outcome|Placebo Cream (Vehicle Control)|Placebo Cream (Vehicle Control)
68101|NCT02152007|O1|Outcome|Split-body 1% Sirolimus Cream (TD201 1%)|"This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.~1% sirolimus cream (TD201 1%): 1% sirolimus cream (TD201 1%)"
68102|NCT02152007|O1|Outcome|Split-body 1% Sirolimus Cream (TD201 1%)|"This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.~1% sirolimus cream (TD201 1%): 1% sirolimus cream (TD201 1%)"
68103|NCT02152007|E1|Reported Event|Split-body 1% Sirolimus Cream (TD201 1%)|"This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.~1% sirolimus cream (TD201 1%): 1% sirolimus cream (TD201 1%)"
68104|NCT02151994|B4|Baseline|Total|Total of all reporting groups
68131|NCT02151994|O8|Outcome|800 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
68132|NCT02151994|O7|Outcome|400 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
68133|NCT02151994|O6|Outcome|200 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
68134|NCT02151994|O5|Outcome|100 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
68135|NCT02151994|O4|Outcome|50 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
68105|NCT02151994|B3|Baseline|Food Interaction (Food Effect, FE) Analysis|This part consisted of an eligibility screening period, an open-label two-way crossover study period, and a follow-up period. One group of 12 subjects received single doses of 400 mg BIA 5-1058 during 2 treatment periods, once after having fasted overnight and once after consumption of a high fat breakfast. Each treatment was separated by a period of at least 7 days. The treatment sequence was determined by randomisation.
68106|NCT02151994|B2|Baseline|Multiple Ascending Dose (MAD)|This part consisted of an eligibility screening period, one study period involving administration of multiple doses of BIA 5-1058 or placebo once daily for 10 days, and a follow-up period. Five sequential groups of 8 healthy young male subjects were dosed. Within each group, 6 subjects were randomised to receive BIA 5-1058 and 2 subjects were randomised to receive placebo.
68107|NCT02151994|B1|Baseline|Single Ascending Dose (SAD)|This part consisted of an eligibility screening period, one study period involving administration of single doses of BIA 5-1058 or placebo according to a randomised design, and a follow-up period. Nine sequential groups of 8 healthy young male subjects were dosed. Within each group, 6 subjects were randomised to receive BIA 5-1058 and 2 subjects were randomised to receive placebo.
68108|NCT02151994|P13|Participant Flow|400 mg Fed|BIA 5-1058 (5, 25 and 100 mg) tablets FE part: A single dose of 400 mg BIA 5-1058 on Day 1 under fasted (one period) and fed (one period) conditions.
68109|NCT02151994|P12|Participant Flow|400 mg Fasted|BIA 5-1058 (5, 25 and 100 mg) tablets FE part: A single dose of 400 mg BIA 5-1058 on Day 1 under fasted (one period) and fed (one period) conditions.
68110|NCT02151994|P11|Participant Flow|2400 mg|BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
68111|NCT02151994|P10|Participant Flow|1600 mg|BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
68112|NCT02151994|P9|Participant Flow|1200 mg|BIA 5-1058 (5, 25 and 100 mg) tablets MAD part: Multiple doses of BIA 5-1058 (n=6) or matching placebo (n=2) once daily on Days 1 to 10, at the following dose levels: 50, 100, 200, 400 and 1200 mg.
68113|NCT02151994|P8|Participant Flow|800 mg|BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
68114|NCT02151994|P7|Participant Flow|400 mg|"BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.~MAD part: Multiple doses of BIA 5-1058 (n=6) or matching placebo (n=2) once daily on Days 1 to 10, at the following dose levels: 50, 100, 200, 400 and 1200 mg."
68115|NCT02151994|P6|Participant Flow|200 mg|"BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.~MAD part: Multiple doses of BIA 5-1058 (n=6) or matching placebo (n=2) once daily on Days 1 to 10, at the following dose levels: 50, 100, 200, 400 and 1200 mg."
68116|NCT02151994|P5|Participant Flow|100 mg|"BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.~MAD part: Multiple doses of BIA 5-1058 (n=6) or matching placebo (n=2) once daily on Days 1 to 10, at the following dose levels: 50, 100, 200, 400 and 1200 mg."
68117|NCT02151994|P4|Participant Flow|50 mg|"BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.~MAD part: Multiple doses of BIA 5-1058 (n=6) or matching placebo (n=2) once daily on Days 1 to 10, at the following dose levels: 50, 100, 200, 400 and 1200 mg."
68118|NCT02151994|P3|Participant Flow|25 mg|BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
68119|NCT02151994|P2|Participant Flow|5 mg|BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
68120|NCT02151994|P1|Participant Flow|Placebo|Placebo : visually matching active medication
68121|NCT02151994|O2|Outcome|400 mg Fed|BIA 5-1058 (5, 25 and 100 mg) tablets
68122|NCT02151994|O1|Outcome|400 mg Fasted|BIA 5-1058 (5, 25 and 100 mg) tablets
68123|NCT02151994|O6|Outcome|1200 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
68124|NCT02151994|O5|Outcome|400 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
68125|NCT02151994|O4|Outcome|200 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
68126|NCT02151994|O3|Outcome|100 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
68127|NCT02151994|O2|Outcome|50 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
68138|NCT02151994|O1|Outcome|Placebo|Placebo : visually matching active medication
68139|NCT02151994|E18|Reported Event|1200 mg (MAD Period)|MAD period
68140|NCT02151994|E17|Reported Event|400 mg (MAD Period)|MAD period
68141|NCT02151994|E16|Reported Event|200 mg (MAD Period)|MAD period
68142|NCT02151994|E15|Reported Event|100 mg (MAD Period)|MAD period
68143|NCT02151994|E14|Reported Event|50 mg (MAD Period)|MAD period
68144|NCT02151994|E13|Reported Event|Placebo (MAD Period)|MAD period
68145|NCT02151994|E12|Reported Event|400 mg Fed (FE Period)|FE period
68146|NCT02151994|E11|Reported Event|400 mg Fasted (FE Period)|FE period
68147|NCT02151994|E10|Reported Event|2400 mg (SAD)|SAD period
68148|NCT02151994|E9|Reported Event|1600 mg (SAD)|SAD period
68149|NCT02151994|E8|Reported Event|800 mg (SAD)|SAD period
68150|NCT02151994|E7|Reported Event|400 mg (SAD)|SAD period
68151|NCT02151994|E6|Reported Event|200 mg (SAD)|SAD period
68152|NCT02151994|E5|Reported Event|100 mg (SAD)|SAD period
68153|NCT02151994|E4|Reported Event|50 mg (SAD)|SAD period
68154|NCT02151994|E3|Reported Event|25 mg (SAD)|SAD period
68155|NCT02151994|E2|Reported Event|5 mg (SAD)|SAD period
68156|NCT02151994|E1|Reported Event|Placebo (SAD)|SAD period
68157|NCT02151981|B3|Baseline|Total|Total of all reporting groups
68158|NCT02151981|B2|Baseline|Chemotherapy|Platinum-based doublet chemotherapy
68159|NCT02151981|B1|Baseline|AZD9291 80 mg|Daily single dose of AZD9291 80mg
68160|NCT02151981|P2|Participant Flow|Chemotherapy|Platinum-based doublet chemotherapy
68161|NCT02151981|P1|Participant Flow|AZD9291 80 mg|Daily single dose of AZD9291 80mg
68162|NCT02151981|O2|Outcome|Chemotherapy|Platinum-based doublet chemotherapy
68163|NCT02151981|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
68164|NCT02151981|O2|Outcome|Chemotherapy|Platinum-based doublet chemotherapy
68165|NCT02151981|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
68166|NCT02151981|O2|Outcome|Chemotherapy|Platinum-based doublet chemotherapy
68167|NCT02151981|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
68168|NCT02151981|O2|Outcome|Chemotherapy|Platinum-based doublet chemotherapy
68169|NCT02151981|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
68170|NCT02151981|O2|Outcome|Chemotherapy|Platinum-based doublet chemotherapy
68171|NCT02151981|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
68172|NCT02151981|O2|Outcome|Chemotherapy|Platinum-based doublet chemotherapy
68173|NCT02151981|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
68174|NCT02151981|E2|Reported Event|Chemotherapy|Platinum-based doublet chemotherapy
68175|NCT02151981|E1|Reported Event|AZD9291 80 mg|Daily single dose of AZD9291 80mg
68176|NCT02151851|B3|Baseline|Total Title|
68177|NCT02151851|B2|Baseline|Certolizumab Pegol + Methotrexate|"Subjects will receive loading doses of CZP 400 mg (200 mg / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then CZP 200 mg (1 injection) Q2W until Week 22.~All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week)."
68178|NCT02151851|B1|Baseline|Placebo + Methotrexate|"Subjects will receive Placebo (1mL / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then Placebo (1 injection) Q2W until Week 22.~All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week)."
68179|NCT02151851|P2|Participant Flow|Certolizumab Pegol + Methotrexate|"Subjects will receive loading doses of CZP 400 mg (200 mg / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then CZP 200 mg (1 injection) Q2W until Week 22.~All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week)."
68180|NCT02151851|P1|Participant Flow|Placebo + Methotrexate|"Subjects will receive Placebo (1mL / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then Placebo (1 injection) Q2W until Week 22.~All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week)."
68181|NCT02151851|O2|Outcome|Certolizumab Pegol + Methotrexate (FAS)|"Subjects will receive loading doses of CZP 400 mg (200 mg / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then CZP 200 mg (1 injection) Q2W until Week 22.~All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week)."
68182|NCT02151851|O1|Outcome|Placebo + Methotrexate (FAS)|"Subjects will receive Placebo (1mL / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then Placebo (1 injection) Q2W until Week 22.~All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week)."
68183|NCT02151851|O2|Outcome|Certolizumab Pegol + Methotrexate (FAS)|"Subjects will receive loading doses of CZP 400 mg (200 mg / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then CZP 200 mg (1 injection) Q2W until Week 22.~All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week)."
68210|NCT02151643|B3|Baseline|Group 3 - PT20 1600 mg Tid|"PT20 1600 mg tid (4.8 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68294|NCT02151461|E4|Reported Event|Control|Day 1-14: 500mg, Day 15-28: 850mg
68184|NCT02151851|O1|Outcome|Placebo + Methotrexate (FAS)|"Subjects will receive Placebo (1mL / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then Placebo (1 injection) Q2W until Week 22.~All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week)."
68185|NCT02151851|O2|Outcome|Certolizumab Pegol + Methotrexate (FAS)|"Subjects will receive loading doses of CZP 400 mg (200 mg / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then CZP 200 mg (1 injection) Q2W until Week 22.~All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week)."
68186|NCT02151851|O1|Outcome|Placebo + Methotrexate (FAS)|"Subjects will receive Placebo (1mL / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then Placebo (1 injection) Q2W until Week 22.~All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week)."
68187|NCT02151851|O2|Outcome|Certolizumab Pegol + Methotrexate (FAS)|"Subjects will receive loading doses of CZP 400 mg (200 mg / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then CZP 200 mg (1 injection) Q2W until Week 22.~All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week)."
68188|NCT02151851|O1|Outcome|Placebo + Methotrexate (FAS)|"Subjects will receive Placebo (1mL / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then Placebo (1 injection) Q2W until Week 22.~All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week)."
68189|NCT02151851|E2|Reported Event|Certolizumab Pegol + Methotrexate (SS)|"Subjects will receive loading doses of CZP 400 mg (200 mg / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then CZP 200 mg (1 injection) Q2W until Week 22.~All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week)."
68190|NCT02151851|E1|Reported Event|Placebo + Methotrexate (SS)|"Subjects will receive Placebo (1mL / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then Placebo (1 injection) Q2W until Week 22.~All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week)."
68191|NCT02151786|B1|Baseline|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
68192|NCT02151786|P1|Participant Flow|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
68193|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
68194|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
68195|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
68196|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
68197|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
68198|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
68199|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
68200|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
68201|NCT02151786|E1|Reported Event|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
68202|NCT02151773|B1|Baseline|Live Attenuated Measles/Rubella Combined Vaccine|Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 mL, injection, subcutaneously as a single dose as per routine medical practice were observed.
68203|NCT02151773|P1|Participant Flow|Live Attenuated Measles/Rubella Combined Vaccine|Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 milliliter (mL), injection, subcutaneously as a single dose as per routine medical practice were observed.
68204|NCT02151773|O1|Outcome|Live Attenuated Measles/Rubella Combined Vaccine|Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 mL, injection, subcutaneously as a single dose as per routine medical practice were observed.
68205|NCT02151773|O1|Outcome|Live Attenuated Measles/Rubella Combined Vaccine|Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 mL, injection, subcutaneously as a single dose as per routine medical practice were observed.
68206|NCT02151773|E1|Reported Event|Live Attenuated Measles/Rubella Combined Vaccine|Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 mL, injection, subcutaneously as a single dose as per routine medical practice were observed.
68207|NCT02151643|B6|Baseline|Total|Total of all reporting groups
68208|NCT02151643|B5|Baseline|Group 5 - Placebo Tid|"Matched Placebo (for PT20) tid administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68209|NCT02151643|B4|Baseline|Group 4 - PT20 3200 mg Tid|"PT20 3200 mg tid (9.6 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68211|NCT02151643|B2|Baseline|Group 2 - PT20 800 mg Tid|"PT20 800 mg tid (2.4 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68212|NCT02151643|B1|Baseline|Group 1 - PT20 400 mg Tid|"PT20 400 mg tid (1.2 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68213|NCT02151643|P5|Participant Flow|Group 5 - Placebo Tid|"Matched Placebo (for PT20) tid administered orally~Placebo: Placebo tablets matched to each active PT20 dosage arm"
68214|NCT02151643|P4|Participant Flow|Group 4 - PT20 3200 mg Tid|"PT20 3200 mg tid (9.6 g/day) administered orally~PT20: Modified ferric oxide adipate"
68215|NCT02151643|P3|Participant Flow|Group 3 - PT20 1600 mg Tid|"PT20 1600 mg tid (4.8 g/day) administered orally~PT20: Modified ferric oxide adipate"
68216|NCT02151643|P2|Participant Flow|Group 2 - PT20 800 mg Tid|"PT20 800 mg tid (2.4 g/day) administered orally~PT20: Modified ferric oxide adipate"
68217|NCT02151643|P1|Participant Flow|Group 1 - PT20 400 mg Tid|"PT20 400 mg tid (1.2 g/day) administered orally~PT20: Modified ferric oxide adipate"
68218|NCT02151643|O5|Outcome|Group 5 - Placebo Tid|"Matched Placebo (for PT20) tid administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68219|NCT02151643|O4|Outcome|Group 4 - PT20 3200 mg Tid|"PT20 3200 mg tid (9.6 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68220|NCT02151643|O3|Outcome|Group 3 - PT20 1600 mg Tid|"PT20 1600 mg tid (4.8 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68221|NCT02151643|O2|Outcome|Group 2 - PT20 800 mg Tid|"PT20 800 mg tid (2.4 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68222|NCT02151643|O1|Outcome|Group 1 - PT20 400 mg Tid|"PT20 400 mg tid (1.2 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68223|NCT02151643|O5|Outcome|Group 5 - Placebo Tid|"Matched Placebo (for PT20) tid administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68224|NCT02151643|O4|Outcome|Group 4 - PT20 3200 mg Tid|"PT20 3200 mg tid (9.6 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68225|NCT02151643|O3|Outcome|Group 3 - PT20 1600 mg Tid|"PT20 1600 mg tid (4.8 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68226|NCT02151643|O2|Outcome|Group 2 - PT20 800 mg Tid|"PT20 800 mg tid (2.4 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68227|NCT02151643|O1|Outcome|Group 1 - PT20 400 mg Tid|"PT20 400 mg tid (1.2 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68228|NCT02151643|O5|Outcome|Group 5 - Placebo Tid|"Matched Placebo (for PT20) tid administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68229|NCT02151643|O4|Outcome|Group 4 - PT20 3200 mg Tid|"PT20 3200 mg tid (9.6 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68230|NCT02151643|O3|Outcome|Group 3 - PT20 1600 mg Tid|"PT20 1600 mg tid (4.8 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68231|NCT02151643|O2|Outcome|Group 2 - PT20 800 mg Tid|"PT20 800 mg tid (2.4 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68232|NCT02151643|O1|Outcome|Group 1 - PT20 400 mg Tid|"PT20 400 mg tid (1.2 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68233|NCT02151643|O5|Outcome|Group 5 - Placebo Tid|"Matched Placebo (for PT20) tid administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68234|NCT02151643|O4|Outcome|Group 4 - PT20 3200 mg Tid|"PT20 3200 mg tid (9.6 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68235|NCT02151643|O3|Outcome|Group 3 - PT20 1600 mg Tid|"PT20 1600 mg tid (4.8 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68273|NCT02151461|O1|Outcome|FDC125|Leucine 1100mg +Metformin 125mg
68236|NCT02151643|O2|Outcome|Group 2 - PT20 800 mg Tid|"PT20 800 mg tid (2.4 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68237|NCT02151643|O1|Outcome|Group 1 - PT20 400 mg Tid|"PT20 400 mg tid (1.2 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68238|NCT02151643|O5|Outcome|Group 5 - Placebo Tid|"Matched Placebo (for PT20) tid administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68239|NCT02151643|O4|Outcome|Group 4 - PT20 3200 mg Tid|"PT20 3200 mg tid (9.6 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68240|NCT02151643|O3|Outcome|Group 3 - PT20 1600 mg Tid|"PT20 1600 mg tid (4.8 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68241|NCT02151643|O2|Outcome|Group 2 - PT20 800 mg Tid|"PT20 800 mg tid (2.4 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68242|NCT02151643|O1|Outcome|Group 1 - PT20 400 mg Tid|"PT20 400 mg tid (1.2 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68243|NCT02151643|O5|Outcome|Group 5 - Placebo Tid|"Matched Placebo (for PT20) tid administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68244|NCT02151643|O4|Outcome|Group 4 - PT20 3200 mg Tid|"PT20 3200 mg tid (9.6 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68245|NCT02151643|O3|Outcome|Group 3 - PT20 1600 mg Tid|"PT20 1600 mg tid (4.8 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68246|NCT02151643|O2|Outcome|Group 2 - PT20 800 mg Tid|"PT20 800 mg tid (2.4 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68247|NCT02151643|O1|Outcome|Group 1 - PT20 400 mg Tid|"PT20 400 mg tid (1.2 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68248|NCT02151643|E5|Reported Event|Group 5 - Placebo Tid|"Matched Placebo (for PT20) tid administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68249|NCT02151643|E4|Reported Event|Group 4 - PT20 3200 mg Tid|"PT20 3200 mg tid (9.6 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68250|NCT02151643|E3|Reported Event|Group 3 - PT20 1600 mg Tid|"PT20 1600 mg tid (4.8 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68251|NCT02151643|E2|Reported Event|Group 2 - PT20 800 mg Tid|"PT20 800 mg tid (2.4 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68252|NCT02151643|E1|Reported Event|Group 1 - PT20 400 mg Tid|"PT20 400 mg tid (1.2 g/day) administered orally.~Dosing was initiated with the subject’s first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
68253|NCT02151461|B5|Baseline|Total|Total of all reporting groups
68254|NCT02151461|B4|Baseline|Control|Day 1-14: 500mg, Day 15-28: 850mg
68255|NCT02151461|B3|Baseline|FDC500|Leucine 1100mg +Metformin 500mg
68256|NCT02151461|B2|Baseline|FDC250|Leucine 1100mg +Metformin 250mg
68257|NCT02151461|B1|Baseline|FDC125|Leucine 1100mg +Metformin 125mg
68258|NCT02151461|P4|Participant Flow|Control|Day 1-14: 500mg, Day 15-28: 850mg
68259|NCT02151461|P3|Participant Flow|FDC500|Leucine 1100mg +Metformin 500mg
68260|NCT02151461|P2|Participant Flow|FDC250|Leucine 1100mg +Metformin 250mg
68261|NCT02151461|P1|Participant Flow|FDC125|Leucine 1100mg +Metformin 125mg
68262|NCT02151461|O4|Outcome|Control|Day 1-14: 500mg, Day 15-28: 850mg
68263|NCT02151461|O3|Outcome|FDC500|Leucine 1100mg +Metformin 500mg
68264|NCT02151461|O2|Outcome|FDC250|Leucine 1100mg +Metformin 250mg
68265|NCT02151461|O1|Outcome|FDC125|Leucine 1100mg +Metformin 125mg
68266|NCT02151461|O4|Outcome|Control|Day 1-14: 500mg, Day 15-28: 850mg
68267|NCT02151461|O3|Outcome|FDC500|Leucine 1100mg +Metformin 500mg
68268|NCT02151461|O2|Outcome|FDC250|Leucine 1100mg +Metformin 250mg
68269|NCT02151461|O1|Outcome|FDC125|Leucine 1100mg +Metformin 125mg
68270|NCT02151461|O4|Outcome|Control|Day 1-14: 500mg, Day 15-28: 850mg
68271|NCT02151461|O3|Outcome|FDC500|Leucine 1100mg +Metformin 500mg
68272|NCT02151461|O2|Outcome|FDC250|Leucine 1100mg +Metformin 250mg
68295|NCT02151461|E3|Reported Event|FDC500|Leucine 1100mg +Metformin 500mg
68296|NCT02151461|E2|Reported Event|FDC250|Leucine 1100mg +Metformin 250mg
68297|NCT02151461|E1|Reported Event|FDC125|Leucine 1100mg +Metformin 125mg
68298|NCT02151253|B1|Baseline|All Randomized Participants|
68299|NCT02151253|P2|Participant Flow|Placebo First, Then Armodafinil|"During double-blind treatment subjects took placebo for 4 weeks before crossing over to armodafinil for 4 weeks. Pill is taken once daily, before 8 am.~Armodafinil/placebo was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator’s and patient’s perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator’s and patient’s perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects."
68300|NCT02151253|P1|Participant Flow|Armodafinil First, Then Placebo|"During double-blind treatment subjects took armodafinil for 4 weeks before crossing over to placebo for 4 weeks. Pill is taken once daily, before 8 am.~Armodafinil/placebo was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator’s and patient’s perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator’s and patient’s perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects."
68301|NCT02151253|O2|Outcome|Placebo|Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
68302|NCT02151253|O1|Outcome|Armodafinil|Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
68303|NCT02151253|O2|Outcome|Placebo|Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
68304|NCT02151253|O1|Outcome|Armodafinil|Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
68305|NCT02151253|O2|Outcome|Placebo|Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
68306|NCT02151253|O1|Outcome|Armodafinil|Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
68307|NCT02151253|O2|Outcome|Placebo|Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
68308|NCT02151253|O1|Outcome|Armodafinil|Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
68309|NCT02151253|O2|Outcome|Placebo|Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator’s and patient’s perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator’s and patient’s perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
68345|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
68346|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
68310|NCT02151253|O1|Outcome|Armodafinil|Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator’s and patient’s perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator’s and patient’s perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
68311|NCT02151253|E2|Reported Event|Placebo|Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
68312|NCT02151253|E1|Reported Event|Armodafinil|Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
68313|NCT02151058|B4|Baseline|Total|Total of all reporting groups
68314|NCT02151058|B3|Baseline|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
68315|NCT02151058|B2|Baseline|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
68316|NCT02151058|B1|Baseline|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
68317|NCT02151058|P3|Participant Flow|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
68318|NCT02151058|P2|Participant Flow|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
68319|NCT02151058|P1|Participant Flow|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
68320|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
68321|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
68322|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
68323|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
68324|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
68325|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
68326|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
68327|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
68328|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
68329|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
68330|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
68331|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
68332|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
68333|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
68334|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
68335|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
68336|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
68337|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
68338|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
68339|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
68340|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
68341|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
68342|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
68343|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
68344|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
68347|NCT02151058|E3|Reported Event|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
68348|NCT02151058|E2|Reported Event|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
68349|NCT02151058|E1|Reported Event|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
68350|NCT02150954|B3|Baseline|Total|Total of all reporting groups
68351|NCT02150954|B2|Baseline|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
68352|NCT02150954|B1|Baseline|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
68353|NCT02150954|P2|Participant Flow|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
68354|NCT02150954|P1|Participant Flow|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
68355|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
68356|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
68357|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
68358|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
68359|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
68360|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
68361|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
68362|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
68363|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
68364|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
68365|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
68366|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
68367|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
68368|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
68369|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
68370|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
68371|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
68372|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
68373|NCT02150954|E2|Reported Event|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
68374|NCT02150954|E1|Reported Event|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
68375|NCT02150499|B3|Baseline|Total|Total of all reporting groups
68376|NCT02150499|B2|Baseline|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
68377|NCT02150499|B1|Baseline|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
68456|NCT02149875|O2|Outcome|Cerebrolysin|Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days.
68457|NCT02149875|O1|Outcome|Dl-3-n-butylphthalide|Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days.
68458|NCT02149875|O3|Outcome|Placebo|Intravenous infusion of 100 ml saline intravenous q.d. for 10 days.
68378|NCT02150499|P2|Participant Flow|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
68379|NCT02150499|P1|Participant Flow|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
68380|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
68381|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
68382|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
68383|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
68384|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
68385|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
68386|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
68387|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
68388|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
68389|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
68390|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
68391|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
68392|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
68393|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
68394|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
68395|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
68459|NCT02149875|O2|Outcome|Cerebrolysin|Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days.
68460|NCT02149875|O1|Outcome|Dl-3-n-butylphthalide|Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days.
68396|NCT02150499|E2|Reported Event|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
68397|NCT02150499|E1|Reported Event|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
68398|NCT02150460|B3|Baseline|Total|Total of all reporting groups
68399|NCT02150460|B2|Baseline|Two-site Peribulbar Injection|"Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15IU/ml into the infero-temporal and supero-nasal orbital compartments~Two- site peribulbar injection: Two injections into the infero-temporal and supero-nasal orbital compartments"
68400|NCT02150460|B1|Baseline|One-site Peribulbar Injection|"Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15 International Units (IU)/ml into the inferior medial orbital compartment~One-site peribulbar injection: injection into the inferior medial orbital compartment"
68401|NCT02150460|P2|Participant Flow|Two-site Peribulbar Injection|"Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15IU/ml into the infero-temporal and supero-nasal orbital compartments~Two- site peribulbar injection: Two injections into the infero-temporal and supero-nasal orbital compartments"
68402|NCT02150460|P1|Participant Flow|One-site Peribulbar Injection|"Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15 International Units (IU)/ml into the inferior medial orbital compartment~One-site peribulbar injection: injection into the inferior medial orbital compartment"
68403|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
68404|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
68405|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
68406|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
68407|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
68408|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
68409|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
68410|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
68411|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
68412|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
68413|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
68414|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
68415|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
68416|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
68417|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
68418|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
68419|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
68420|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
68421|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
68422|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
68423|NCT02150460|E2|Reported Event|Group 2|Two-site peribulbar injection
68424|NCT02150460|E1|Reported Event|Group 1|One-site peribulbar injection
68425|NCT02150213|B1|Baseline|BGG492|This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
68426|NCT02150213|P1|Participant Flow|BGG492|This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
68427|NCT02150213|O1|Outcome|BGG492|This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
68428|NCT02150213|O1|Outcome|BGG492|This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
68429|NCT02150213|E1|Reported Event|BGG492|This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
68430|NCT02150109|B1|Baseline|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH (329) and WITHOUT (43) diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
68431|NCT02150109|P1|Participant Flow|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
68461|NCT02149875|E3|Reported Event|Placebo|Intravenous infusion of 100 ml saline intravenous q.d. for 10 days.
68462|NCT02149875|E2|Reported Event|Cerebrolysin|Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days.
68463|NCT02149875|E1|Reported Event|Dl-3-n-butylphthalide|Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days.
68617|NCT02148107|O1|Outcome|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
68432|NCT02150109|O1|Outcome|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
68433|NCT02150109|O1|Outcome|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Study staff tested subject fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
68434|NCT02150109|O1|Outcome|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Study staff tested subject fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
68435|NCT02150109|O1|Outcome|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
68436|NCT02150109|O1|Outcome|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
68437|NCT02150109|O1|Outcome|Persons With Diabetes|"Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH diabetes (329) used the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
68438|NCT02150109|O1|Outcome|Persons With Diabetes|"Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH Diabetes Use Karajishi Contour BGMS: Study staff tested subject fingerstick blood (329 WITH Diabetes) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
68439|NCT02150109|O1|Outcome|Persons With Diabetes|"Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH Diabetes Use Karajishi Contour BGMS: Study staff tested subject venous blood from subjects WITH Diabetes (329) and BG results were compared to reference method results obtained from subject venous plasma."
68440|NCT02150109|O1|Outcome|Persons With Diabetes|"Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH (329) Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH diabetes used the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
68441|NCT02150109|E1|Reported Event|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
68442|NCT02150044|B1|Baseline|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system~Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
68443|NCT02150044|P1|Participant Flow|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system~Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
68444|NCT02150044|O1|Outcome|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system~Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
68445|NCT02150044|O1|Outcome|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system~Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
68446|NCT02150044|O1|Outcome|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system~Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
68447|NCT02150044|E1|Reported Event|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system~Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
68448|NCT02149875|B4|Baseline|Total|Total of all reporting groups
68449|NCT02149875|B3|Baseline|Placebo|Intravenous infusion of 100 ml saline intravenous q.d. for 10 days.
68450|NCT02149875|B2|Baseline|Cerebrolysin|Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days.
68451|NCT02149875|B1|Baseline|Dl-3-n-butylphthalide|Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days.
68452|NCT02149875|P3|Participant Flow|Placebo|"Intravenous infusion of 100 ml saline intravenous q.d. for 10 days~Dl-3-n-butylphthalide, Cerebrolysin and Placebo separately"
68453|NCT02149875|P2|Participant Flow|Cerebrolysin|"Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days~Dl-3-n-butylphthalide, Cerebrolysin and Placebo separately"
68454|NCT02149875|P1|Participant Flow|Dl-3-n-butylphthalide|"Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days~Dl-3-n-butylphthalide, Cerebrolysin and Placebo separately"
68455|NCT02149875|O3|Outcome|Placebo|Intravenous infusion of 100 ml saline intravenous q.d. for 10 days.
68464|NCT02149342|B1|Baseline|Hexylaminolaevulinate and Methylaminoalevulinate Cream|0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) and 16% methylaminolaevulinate (Metvix, Galderma) in a split-face design
68465|NCT02149342|P1|Participant Flow|Hexylaminolaevulinate and Methylaminoalevulinate Creams|"0,2% hexylaminolaevulinate cream , HAL (Hexvix, Photocure, Unguentum M, Almirall) 16% methylaminolaevulinate, MAL (Metvix, Galderma)~HAL and MAL used as photosensitizer for daylight-PDT in a randomized split-face design"
68466|NCT02149342|O2|Outcome|Methylaminolaevulinate Cream|"16% methylaminolaevulinate (Metvix, Galderma)~Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT"
68467|NCT02149342|O1|Outcome|Hexylaminolaevulinate Cream|"0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) (2014) 2% hexylaminolaevulinate (Hexvix Photocure) mixed with Unguentum M (Allmiral) (2015)~Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)"
68468|NCT02149342|O2|Outcome|Methylaminolaevulinate Cream|"16% methylaminolaevulinate (Metvix, Galderma)~Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT"
68469|NCT02149342|O1|Outcome|Hexylaminolaevulinate Cream|"0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) (2014) 2% hexylaminolaevulinate (Hexvix Photocure) mixed with Unguentum M (Allmiral) (2015)~Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)"
68470|NCT02149342|O2|Outcome|Methylaminolaevulinate Cream|"16% methylaminolaevulinate (Metvix, Galderma)~Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT"
68471|NCT02149342|O1|Outcome|Hexylaminolaevulinate Cream|"0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) (2014) 2% hexylaminolaevulinate (Hexvix Photocure) mixed with Unguentum M (Allmiral) (2015)~Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)"
68472|NCT02149342|O2|Outcome|Methylaminolaevulinate Cream|"16% methylaminolaevulinate (Metvix, Galderma)~Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT"
68473|NCT02149342|O1|Outcome|Hexylaminolaevulinate Cream|"0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral)~Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream"
68474|NCT02149342|E2|Reported Event|Methylaminolaevulinate Cream|"16% methylaminolaevulinate (Metvix, Galderma)~Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT"
68475|NCT02149342|E1|Reported Event|Hexylaminolaevulinate Cream|"0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) (2014) 2% hexylaminolaevulinate (Hexvix Photocure) mixed with Unguentum M (Allmiral) (2015)~Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)"
68476|NCT02149303|B1|Baseline|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
68477|NCT02149303|P1|Participant Flow|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
68478|NCT02149303|O1|Outcome|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
68479|NCT02149303|O1|Outcome|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
68480|NCT02149303|O1|Outcome|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
68481|NCT02149303|E1|Reported Event|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
68482|NCT02149264|B1|Baseline|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
68483|NCT02149264|P1|Participant Flow|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
68484|NCT02149264|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
68485|NCT02149264|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
68486|NCT02149264|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
68545|NCT02148523|B4|Baseline|Total|Total of all reporting groups
68487|NCT02149264|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
68488|NCT02149264|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
68489|NCT02149264|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
68490|NCT02149264|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
68491|NCT02149264|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
68492|NCT02149264|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
68493|NCT02149264|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
68494|NCT02149264|E1|Reported Event|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
68495|NCT02149108|B3|Baseline|Total|Total of all reporting groups
68496|NCT02149108|B2|Baseline|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) administered orally in the form of a soft gelatin capsule of 21-day treatment course. If required the dose of Nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
68497|NCT02149108|B1|Baseline|Placebo|Placebo soft gelatin capsule matching that of Nintedanib twice daily (b.i.d.) administered orally of 21-day treatment course. If required the dose of placebo, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
68498|NCT02149108|P2|Participant Flow|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) administered orally in the form of a soft gelatin capsule of 21-day treatment course. If required the dose of Nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
68499|NCT02149108|P1|Participant Flow|Placebo|Placebo soft gelatin capsule matching that of Nintedanib twice daily (b.i.d.) administered orally of 21-day treatment course. If required the dose of placebo, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
68500|NCT02149108|O2|Outcome|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) administered orally in the form of a soft gelatin capsule of 21-day treatment course. If required the dose of Nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
68501|NCT02149108|O1|Outcome|Placebo|Placebo soft gelatin capsule matching that of Nintedanib twice daily (b.i.d.) administered orally of 21-day treatment course. If required the dose of placebo, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
68502|NCT02149108|O2|Outcome|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) administered orally in the form of a soft gelatin capsule of 21-day treatment course. If required the dose of Nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
68503|NCT02149108|O1|Outcome|Placebo|Placebo soft gelatin capsule matching that of Nintedanib twice daily (b.i.d.) administered orally of 21-day treatment course. If required the dose of placebo, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
68504|NCT02149108|O2|Outcome|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) administered orally in the form of a soft gelatin capsule of 21-day treatment course. If required the dose of Nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
68505|NCT02149108|O1|Outcome|Placebo|Placebo soft gelatin capsule matching that of Nintedanib twice daily (b.i.d.) administered orally of 21-day treatment course. If required the dose of placebo, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
68506|NCT02149108|O2|Outcome|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) administered orally in the form of a soft gelatin capsule of 21-day treatment course. If required the dose of Nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
68507|NCT02149108|O1|Outcome|Placebo|Placebo soft gelatin capsule matching that of Nintedanib twice daily (b.i.d.) administered orally of 21-day treatment course. If required the dose of placebo, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
68508|NCT02149108|E2|Reported Event|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) administered orally in the form of a soft gelatin capsule of 21-day treatment course. If required the dose of Nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
68509|NCT02149108|E1|Reported Event|Placebo|Placebo soft gelatin capsule matching that of Nintedanib twice daily (b.i.d.) administered orally of 21-day treatment course. If required the dose of placebo, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
68510|NCT02148809|B1|Baseline|Pilot Study|"14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study (Table 1).~Exclusion criteria were blood coagulopathies, medication with anti-coagulants, coronary artery disease, congestive heart failure, kidney insufficiency (creatinine > 1.5 mg/dl), aortic or mitral valve disease, pulmonary hypertension, and known hypersensitivity to the tracer.~All of them underwent total hip arthroplasty by one high-volume surgeon using a posterior or anterior approach."
68511|NCT02148809|P1|Participant Flow|Pilot Study|"14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study (Table 1).~Exclusion criteria were blood coagulopathies, medication with anti-coagulants, coronary artery disease, congestive heart failure, kidney insufficiency (creatinine > 1.5 mg/dl), aortic or mitral valve disease, pulmonary hypertension, and known hypersensitivity to the tracer.~All of them underwent total hip arthroplasty by one high-volume surgeon using a posterior or anterior approach."
68512|NCT02148809|O1|Outcome|Pilot Study|14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study
68513|NCT02148809|O1|Outcome|Pilot Study|"14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study (Table 1).~Exclusion criteria were blood coagulopathies, medication with anti-coagulants, coronary artery disease, congestive heart failure, kidney insufficiency (creatinine > 1.5 mg/dl), aortic or mitral valve disease, pulmonary hypertension, and known hypersensitivity to the tracer.~All of them underwent total hip arthroplasty by one high-volume surgeon using a posterior or anterior approach."
68514|NCT02148809|E1|Reported Event|Pilot Study|14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study
68515|NCT02148718|B1|Baseline|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
68516|NCT02148718|P1|Participant Flow|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
68517|NCT02148718|O1|Outcome|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
68518|NCT02148718|O1|Outcome|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
68519|NCT02148718|O1|Outcome|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
68520|NCT02148718|O1|Outcome|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
68521|NCT02148718|O1|Outcome|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
68522|NCT02148718|O1|Outcome|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
68523|NCT02148718|O1|Outcome|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
68524|NCT02148718|O1|Outcome|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
68525|NCT02148718|O1|Outcome|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
68526|NCT02148718|O1|Outcome|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
68527|NCT02148718|O1|Outcome|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
68528|NCT02148718|O1|Outcome|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
68529|NCT02148718|O1|Outcome|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
68530|NCT02148718|O1|Outcome|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
68531|NCT02148718|O1|Outcome|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
68532|NCT02148718|O1|Outcome|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
68533|NCT02148718|O1|Outcome|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
68534|NCT02148718|O1|Outcome|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
68535|NCT02148718|E1|Reported Event|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
68536|NCT02148588|B1|Baseline|The Entire Cohort|All participants received a peripheral nerve block
68537|NCT02148588|P1|Participant Flow|The Entire Cohort|All participants received a peripheral nerve block
68538|NCT02148588|O1|Outcome|The Entire Cohort|All participants received a peripheral nerve block
68539|NCT02148588|O1|Outcome|The Entire Cohort|All participants received a peripheral nerve block
68540|NCT02148588|O1|Outcome|The Entire Cohort|All participants received a peripheral nerve block
68541|NCT02148588|O1|Outcome|The Entire Cohort|All participants received a peripheral nerve block
68542|NCT02148588|O1|Outcome|The Entire Cohort|All participants received a peripheral nerve block
68543|NCT02148588|O1|Outcome|The Entire Cohort|All participants received a peripheral nerve block
68544|NCT02148588|E1|Reported Event|The Entire Cohort|All participants received a peripheral nerve block
68546|NCT02148523|B3|Baseline|Usual Care|"Usual care with GlowCap.~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
68547|NCT02148523|B2|Baseline|Weekly Adherence Peer-Comparison Report|"Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.~Comparison to peers~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
68548|NCT02148523|B1|Baseline|Weekly Adherence Report|"Adherence report to subject every 7 days.~Adherence feedback~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
68549|NCT02148523|P3|Participant Flow|Usual Care|"Usual care with GlowCap.~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
68550|NCT02148523|P2|Participant Flow|Weekly Adherence Peer-Comparison Report|"Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.~Comparison to peers~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
68551|NCT02148523|P1|Participant Flow|Weekly Adherence Report|"Adherence report to subject every 7 days.~Adherence feedback~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
68552|NCT02148523|O3|Outcome|Usual Care|"Usual care with GlowCap.~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
68553|NCT02148523|O2|Outcome|Weekly Adherence Peer-Comparison Report|"Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.~Comparison to peers~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
68554|NCT02148523|O1|Outcome|Weekly Adherence Report|"Adherence report to subject every 7 days.~Adherence feedback~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
68555|NCT02148523|O3|Outcome|Usual Care|"Usual care with GlowCap.~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
68556|NCT02148523|O2|Outcome|Weekly Adherence Peer-Comparison Report|"Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.~Comparison to peers~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
68557|NCT02148523|O1|Outcome|Weekly Adherence Report|"Adherence report to subject every 7 days.~Adherence feedback~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
68558|NCT02148523|E3|Reported Event|Usual Care|"Usual care with GlowCap.~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
68559|NCT02148523|E2|Reported Event|Weekly Adherence Peer-Comparison Report|"Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.~Comparison to peers~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
68560|NCT02148523|E1|Reported Event|Weekly Adherence Report|"Adherence report to subject every 7 days.~Adherence feedback~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
68561|NCT02148445|B3|Baseline|Total|Total of all reporting groups
68562|NCT02148445|B2|Baseline|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
68563|NCT02148445|B1|Baseline|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
68564|NCT02148445|P2|Participant Flow|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
68565|NCT02148445|P1|Participant Flow|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
68566|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|"Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.~Extended Nicotine Replacement Therapy: Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.~Nicotine replacement therapy"
68586|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
68618|NCT02148107|E3|Reported Event|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
68761|NCT02147184|O1|Outcome|SSRI Group|Participants within one month of starting an SSRI
68567|NCT02148445|O1|Outcome|Standard Smoking Cessation|"Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.~Standard Smoking Cessation: Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.~Nicotine replacement therapy"
68568|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
68569|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
68570|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
68571|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
68572|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
68573|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
68574|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
68575|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
68576|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
68577|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
68578|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
68579|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
68580|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
68581|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
68582|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
68583|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
68584|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
68585|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
68587|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
68588|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
68589|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
68590|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
68591|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
68592|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
68593|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
68594|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
68595|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
68596|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
68597|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
68598|NCT02148445|E2|Reported Event|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
68599|NCT02148445|E1|Reported Event|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
68600|NCT02148107|B4|Baseline|Total|Total of all reporting groups
68601|NCT02148107|B3|Baseline|Placebo|Oral administration of a placebo tablet matching the BI 691751 tablets, taken once daily for 14 days.
68602|NCT02148107|B2|Baseline|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
68603|NCT02148107|B1|Baseline|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
68604|NCT02148107|P3|Participant Flow|Placebo|Oral administration of a placebo tablet matching the BI 691751 tablets, taken once daily for 14 days.
68605|NCT02148107|P2|Participant Flow|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
68606|NCT02148107|P1|Participant Flow|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
68607|NCT02148107|O2|Outcome|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
68608|NCT02148107|O1|Outcome|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
68609|NCT02148107|O2|Outcome|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
68610|NCT02148107|O1|Outcome|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
68611|NCT02148107|O2|Outcome|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
68612|NCT02148107|O1|Outcome|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
68613|NCT02148107|O2|Outcome|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
68614|NCT02148107|O1|Outcome|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
68615|NCT02148107|O3|Outcome|Placebo|Oral administration of a placebo tablet matching the BI 691751 tablets, taken once daily for 14 days.
68616|NCT02148107|O2|Outcome|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
68619|NCT02148107|E2|Reported Event|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
68620|NCT02148107|E1|Reported Event|Placebo|Oral administration of a placebo tablet matching the BI 691751 tablets, taken once daily for 14 days.
68621|NCT02147899|B4|Baseline|Total|Total of all reporting groups
68622|NCT02147899|B3|Baseline|Placebo|"Administered orally~Placebo"
68623|NCT02147899|B2|Baseline|SYM-1219 High Dose|"Administered orally~SYM-1219"
68624|NCT02147899|B1|Baseline|SYM-1219 Low Dose|"Administered orally~SYM-1219"
68625|NCT02147899|P3|Participant Flow|Placebo|"Administered orally~Placebo"
68626|NCT02147899|P2|Participant Flow|SYM-1219 High Dose|"Administered orally~SYM-1219"
68627|NCT02147899|P1|Participant Flow|SYM-1219 Low Dose|"Administered orally~SYM-1219"
68628|NCT02147899|O3|Outcome|Placebo|"Administered orally~Placebo"
68629|NCT02147899|O2|Outcome|SYM-1219 High Dose|"Administered orally~SYM-1219"
68630|NCT02147899|O1|Outcome|SYM-1219 Low Dose|"Administered orally~SYM-1219"
68631|NCT02147899|O3|Outcome|Placebo|"Administered orally~Placebo"
68632|NCT02147899|O2|Outcome|SYM-1219 High Dose|"Administered orally~SYM-1219"
68633|NCT02147899|O1|Outcome|SYM-1219 Low Dose|"Administered orally~SYM-1219"
68634|NCT02147899|E3|Reported Event|Placebo|"Administered orally~Placebo"
68635|NCT02147899|E2|Reported Event|SYM-1219 High Dose|"Administered orally~SYM-1219"
68636|NCT02147899|E1|Reported Event|SYM-1219 Low Dose|"Administered orally~SYM-1219"
68637|NCT02147691|B3|Baseline|Total|Total of all reporting groups
68638|NCT02147691|B2|Baseline|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidine 0.33%"
68639|NCT02147691|B1|Baseline|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
68640|NCT02147691|P2|Participant Flow|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidine 0.33%"
68641|NCT02147691|P1|Participant Flow|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 0.33 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
68642|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
68643|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
68644|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
68645|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
68646|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
68647|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
68648|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
68649|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
68650|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
68651|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
68652|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
68653|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
68654|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
68655|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
68656|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
68657|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
68658|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
68659|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
68660|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
68661|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
68662|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
68663|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
68664|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
68665|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
68666|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
68667|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
68668|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
68669|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
68670|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
68671|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
68672|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
68673|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
68674|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
68675|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
68676|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
68677|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
68678|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
68679|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
68680|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
68681|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
68682|NCT02147691|E2|Reported Event|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
68683|NCT02147691|E1|Reported Event|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
68684|NCT02147587|B3|Baseline|Total|Total of all reporting groups
68685|NCT02147587|B2|Baseline|Tofacitinib 5 mg Twice a Day|Following administration of zoster vaccine to RA participants receiving background methotrexate, participants received tofacitinib 5 mg twice a day orally for up to 12 weeks.
68686|NCT02147587|B1|Baseline|Placebo Twice a Day|Following administration of zoster vaccine, participants with Rheumatoid Arthritis (RA) on background methotrexate received placebo matched tofacitinib tablets twice a day orally for up to 12 weeks.
68687|NCT02147587|P2|Participant Flow|Tofacitinib 5 mg Twice a Day|Following administration of zoster vaccine to RA participants receiving background methotrexate, participants received tofacitinib 5 mg twice a day orally for up to 12 weeks.
68688|NCT02147587|P1|Participant Flow|Placebo Twice a Day|Following administration of zoster vaccine, participants with Rheumatoid Arthritis (RA) on background methotrexate received placebo matched tofacitinib tablets twice a day orally for up to 12 weeks.
68689|NCT02147587|O2|Outcome|Tofacitinib 5 mg Twice a Day|Following administration of zoster vaccine to RA participants receiving background methotrexate, participants received tofacitinib 5 mg twice a day orally for up to 12 weeks.
68690|NCT02147587|O1|Outcome|Placebo Twice a Day|Following administration of zoster vaccine, participants with Rheumatoid Arthritis (RA) on background methotrexate received placebo matched tofacitinib tablets twice a day orally for up to 12 weeks.
68691|NCT02147587|O2|Outcome|Tofacitinib 5 mg Twice a Day|Following administration of zoster vaccine to RA participants receiving background methotrexate, participants received tofacitinib 5 mg twice a day orally for up to 12 weeks.
68692|NCT02147587|O1|Outcome|Placebo Twice a Day|Following administration of zoster vaccine, participants with Rheumatoid Arthritis (RA) on background methotrexate received placebo matched tofacitinib tablets twice a day orally for up to 12 weeks.
68693|NCT02147587|O2|Outcome|Tofacitinib 5 mg Twice a Day|Following administration of zoster vaccine to RA participants receiving background methotrexate, participants received tofacitinib 5 mg twice a day orally for up to 12 weeks.
68694|NCT02147587|O1|Outcome|Placebo Twice a Day|Following administration of zoster vaccine, participants with Rheumatoid Arthritis (RA) on background methotrexate received placebo matched tofacitinib tablets twice a day orally for up to 12 weeks.
68695|NCT02147587|O2|Outcome|Tofacitinib 5 mg Twice a Day|Following administration of zoster vaccine to RA participants receiving background methotrexate, participants received tofacitinib 5 mg twice a day orally for up to 12 weeks.
68696|NCT02147587|O1|Outcome|Placebo Twice a Day|Following administration of zoster vaccine, participants with Rheumatoid Arthritis (RA) on background methotrexate received placebo matched tofacitinib tablets twice a day orally for up to 12 weeks.
68697|NCT02147587|O2|Outcome|Tofacitinib 5 mg Twice a Day|Following administration of zoster vaccine to RA participants receiving background methotrexate, participants received tofacitinib 5 mg twice a day orally for up to 12 weeks.
68698|NCT02147587|O1|Outcome|Placebo Twice a Day|Following administration of zoster vaccine, participants with Rheumatoid Arthritis (RA) on background methotrexate received placebo matched tofacitinib tablets twice a day orally for up to 12 weeks.
68699|NCT02147587|O2|Outcome|Tofacitinib 5 mg Twice a Day|Following administration of zoster vaccine to RA participants receiving background methotrexate, participants received tofacitinib 5 mg twice a day orally for up to 12 weeks.
68700|NCT02147587|O1|Outcome|Placebo Twice a Day|Following administration of zoster vaccine, participants with Rheumatoid Arthritis (RA) on background methotrexate received placebo matched tofacitinib tablets twice a day orally for up to 12 weeks.
68701|NCT02147587|O2|Outcome|Tofacitinib 5 mg Twice a Day|Following administration of zoster vaccine to RA participants receiving background methotrexate, participants received tofacitinib 5 mg twice a day orally for up to 12 weeks.
68702|NCT02147587|O1|Outcome|Placebo Twice a Day|Following administration of zoster vaccine, participants with Rheumatoid Arthritis (RA) on background methotrexate received placebo matched tofacitinib tablets twice a day orally for up to 12 weeks.
68703|NCT02147587|O2|Outcome|Tofacitinib 5 mg Twice a Day|Following administration of zoster vaccine to RA participants receiving background methotrexate, participants received tofacitinib 5 mg twice a day orally for up to 12 weeks.
68704|NCT02147587|O1|Outcome|Placebo Twice a Day|Following administration of zoster vaccine, participants with Rheumatoid Arthritis (RA) on background methotrexate received placebo matched tofacitinib tablets twice a day orally for up to 12 weeks.
68705|NCT02147587|E2|Reported Event|Tofacitinib 5 mg Twice a Day|Following administration of zoster vaccine to RA participants receiving background methotrexate, participants received tofacitinib 5 mg twice a day orally for up to 12 weeks.
68706|NCT02147587|E1|Reported Event|Placebo Twice a Day|Following administration of zoster vaccine, participants with Rheumatoid Arthritis (RA) on background methotrexate received placebo matched tofacitinib tablets twice a day orally for up to 12 weeks.
68707|NCT02147561|B1|Baseline|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
68708|NCT02147561|P1|Participant Flow|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
68709|NCT02147561|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
68710|NCT02147561|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
68711|NCT02147561|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
68712|NCT02147561|E1|Reported Event|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
68713|NCT02147522|B3|Baseline|Total|Total of all reporting groups
68714|NCT02147522|B2|Baseline|Usual Care (UC)|"Participants received DHS Patient Centered Medical Home (PCMH) clinic team usual care from their respective county health clinic providers.~PCMH model has available DHS medical providers and social workers for depression care and refer patients when indicated to community mental health clinics. Problem-Solving Therapy (PST) is available in some of participating clinics."
68715|NCT02147522|B1|Baseline|A Helping Hand (AHH)|Participants received DHS-PCMH usual care from their respective county health clinic providers plus the AHH intervention provided by study promotoras. AHH intervention includes 6 weekly in-person or via-telephone intervention sessions followed by 3 monthly telephone booster sessions aimed at reducing the burden and strain on patients, families, and care providers by assessing, enhancing, and facilitating patient depression and co-morbid illness self-care management, and activating patient communication with clinic medical providers.
68716|NCT02147522|P2|Participant Flow|Usual Care (UC)|"Participants received DHS Patient Centered Medical Home (PCMH) clinic usual care from their respective county health clinic providers.~PCMH model has available DHS medical providers and social workers for depression care and refer patients when indicated to community mental health clinics. Problem-Solving Therapy (PST) is available in some of participating clinics."
68717|NCT02147522|P1|Participant Flow|A Helping Hand (AHH)|Participants received PCMH depression care services from their respective county health clinic providers plus the AHH intervention. Promotoras provided 6 weekly in-person or via-telephone intervention followed by 3 monthly telephone sessions aimed at reducing the burden and strain on patients, families, and care providers by assessing, enhancing, and facilitating patient depression and co-morbid illness self-care management, and activating patient communication with clinic medical providers.
68718|NCT02147522|O2|Outcome|Usual Care (UC)|"Participants received DHS Patient Centered Medical Home (PCMH) clinic team usual care from their respective county health clinic providers.~PCMH model has available DHS medical providers and social workers for depression care and refer patients when indicated to community mental health clinics. Problem-Solving Therapy (PST) is available in some of participating clinics."
68719|NCT02147522|O1|Outcome|A Helping Hand (AHH)|Participants received DHS-PCMH usual care from their respective county health clinic providers plus the AHH intervention provided by study promotoras. AHH intervention includes 6 weekly in-person or via-telephone intervention sessions followed by 3 monthly telephone booster sessions aimed at reducing the burden and strain on patients, families, and care providers by assessing, enhancing, and facilitating patient depression and co-morbid illness self-care management, and activating patient communication with clinic medical providers.
68759|NCT02147184|O1|Outcome|SSRI Group|Participants within one month of starting an SSRI
68760|NCT02147184|O2|Outcome|Unmedicated Group|No treatment with SSRIs
68720|NCT02147522|O2|Outcome|Usual Care (UC)|"Participants received DHS Patient Centered Medical Home (PCMH) clinic team usual care from their respective county health clinic providers.~PCMH model has available DHS medical providers and social workers for depression care and refer patients when indicated to community mental health clinics. Problem-Solving Therapy (PST) is available in some of participating clinics."
68721|NCT02147522|O1|Outcome|A Helping Hand (AHH)|Participants received DHS-PCMH usual care from their respective county health clinic providers plus the AHH intervention provided by study promotoras. AHH intervention includes 6 weekly in-person or via-telephone intervention sessions followed by 3 monthly telephone booster sessions aimed at reducing the burden and strain on patients, families, and care providers by assessing, enhancing, and facilitating patient depression and co-morbid illness self-care management, and activating patient communication with clinic medical providers.
68722|NCT02147522|O2|Outcome|Usual Care (UC)|"Participants received DHS Patient Centered Medical Home (PCMH) clinic team usual care from their respective county health clinic providers.~PCMH model has available DHS medical providers and social workers for depression care and refer patients when indicated to community mental health clinics. Problem-Solving Therapy (PST) is available in some of participating clinics."
68723|NCT02147522|O1|Outcome|A Helping Hand (AHH)|Participants received DHS-PCMH usual care from their respective county health clinic providers plus the AHH intervention provided by study promotoras. AHH intervention includes 6 weekly in-person or via-telephone intervention sessions followed by 3 monthly telephone booster sessions aimed at reducing the burden and strain on patients, families, and care providers by assessing, enhancing, and facilitating patient depression and co-morbid illness self-care management, and activating patient communication with clinic medical providers.
68724|NCT02147522|E2|Reported Event|Usual Care (UC)|"Participants received DHS Patient Centered Medical Home (PCMH) clinic usual care from their respective county health clinic providers.~PCMH model has available DHS medical providers and social workers for depression care and refer patients when indicated to community mental health clinics. Problem-Solving Therapy (PST) is available in some of participating clinics."
68725|NCT02147522|E1|Reported Event|A Helping Hand (AHH)|Participants received PCMH depression care services from their respective county health clinic providers plus the AHH intervention. Promotoras provided 6 weekly in-person or via-telephone intervention followed by 3 monthly telephone sessions aimed at reducing the burden and strain on patients, families, and care providers by assessing, enhancing, and facilitating patient depression and co-morbid illness self-care management, and activating patient communication with clinic medical providers.
68726|NCT02147288|B3|Baseline|Total|Total of all reporting groups
68727|NCT02147288|B2|Baseline|Panniculectomy on NPWT|"The Smith&Nephew Renasys*GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm.~Renasys*GO Negative Pressure Wound Therapy System: Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains)."
68728|NCT02147288|B1|Baseline|Panniculectomy on JP Drains|Standard of Care
68729|NCT02147288|P10|Participant Flow|Ventral Hernia Repair (VHR) on JP Drains|
68730|NCT02147288|P9|Participant Flow|Ventral Hernia Repair (VHR) on NPWT|
68731|NCT02147288|P8|Participant Flow|Abdominoplasty on JP Drains|
68732|NCT02147288|P7|Participant Flow|Abdominoplasty on NPWT|
68733|NCT02147288|P6|Participant Flow|Lipoabdominoplasty on JP Drains|
68734|NCT02147288|P5|Participant Flow|Lipoabdominoplasty on NPWT|
68735|NCT02147288|P4|Participant Flow|Breast Recon With ADM on Jackson-Pratt (JP) Drains|
68736|NCT02147288|P3|Participant Flow|Breast Recon With Acellular Dermal Matrix (ADM) on NPWT|
68737|NCT02147288|P2|Participant Flow|Panniculectomy on Negative Pressure Wound Therapy (NPWT)|"The Smith&Nephew Renasys*GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm.~Renasys*GO Negative Pressure Wound Therapy System: Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains)."
68738|NCT02147288|P1|Participant Flow|Panniculectomy on Jackson Pratt (JP) Drains|Standard of Care
68739|NCT02147288|O2|Outcome|Panniculectomy on NPWT|"The Smith&Nephew Renasys*GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm.~Renasys*GO Negative Pressure Wound Therapy System: Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains)."
68740|NCT02147288|O1|Outcome|Panniculectomy on JP Drains|Standard of Care
68741|NCT02147288|E2|Reported Event|Panniculectomy on NPWT|"The Smith&Nephew Renasys*GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm.~Renasys*GO Negative Pressure Wound Therapy System: Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains)."
68742|NCT02147288|E1|Reported Event|Panniculectomy on JP Drains|Standard of Care
68743|NCT02147184|B3|Baseline|Total|Total of all reporting groups
68744|NCT02147184|B2|Baseline|Unmedicated Group|No treatment with SSRIs
68745|NCT02147184|B1|Baseline|SSRI Group|Participants within one month of starting an SSRI
68746|NCT02147184|P2|Participant Flow|Unmedicated Group|No treatment with SSRIs
68747|NCT02147184|P1|Participant Flow|SSRI Group|Participants within one month of starting an SSRI
68748|NCT02147184|O2|Outcome|Unmedicated Group|No treatment with SSRIs
68749|NCT02147184|O1|Outcome|SSRI Group|Participants within one month of starting an SSRI
68750|NCT02147184|O2|Outcome|Unmedicated Group|No treatment with SSRIs
68751|NCT02147184|O1|Outcome|SSRI Group|Participants within one month of starting an SSRI
68752|NCT02147184|O2|Outcome|Unmedicated Group|No treatment with SSRIs
68753|NCT02147184|O1|Outcome|SSRI Group|Participants within one month of starting an SSRI
68754|NCT02147184|O2|Outcome|Unmedicated Group|No treatment with SSRIs
68755|NCT02147184|O1|Outcome|SSRI Group|Participants within one month of starting an SSRI
68756|NCT02147184|O2|Outcome|Unmedicated Group|No treatment with SSRIs
68757|NCT02147184|O1|Outcome|SSRI Group|Participants within one month of starting an SSRI
68758|NCT02147184|O2|Outcome|Unmedicated Group|No treatment with SSRIs
68762|NCT02147184|E2|Reported Event|Unmedicated Group|No treatment with SSRIs
68763|NCT02147184|E1|Reported Event|SSRI Group|Participants within one month of starting an SSRI
68764|NCT02147093|B3|Baseline|Total|Total of all reporting groups
68765|NCT02147093|B2|Baseline|Test (Filcon II 3-multi-focal) / Control (Filcon II 3-spher)|All subjects that were randomized to sequence and were dispensed a study lens.
68766|NCT02147093|B1|Baseline|Control (Filcon II 3-sphere) /Test (Filcon II 3-multi-focal)|All subjects that were randomized to sequence and were dispensed a study lens.
68767|NCT02147093|P2|Participant Flow|Test (Filcon II 3-multi-focal) /Control (Filcon II 3- Sphere)|Subjects were first fitted with the Test lens (filcon II 3-multi-focal) for one week. Subjects were then fitted with Control lens (filcon II 3- sphere) and a pair of reading glasses for one week.
68768|NCT02147093|P1|Participant Flow|Control (Filcon II 3- Sphere) /Test (Filcon II 3-multi-focal)|Subjects were first fitted with the Control lens (filcon II 3- sphere) and a pair of reading glasses for one week. Subjects were then fitted with the Test lens (filcon II 3-multi-focal) for one week.
68769|NCT02147093|O2|Outcome|Test (Filcon II 3-multi-focal)|Subjects that were dispensed the Test lens (filcon II 3-multi-focal) in either the first or second period of the study.
68770|NCT02147093|O1|Outcome|Control (Filcon II 3-sphere)|Subjects that were dispensed the Control lens (filcon II 3-sphere) in either the first or second period of the study.
68771|NCT02147093|O2|Outcome|Test (Filcon II 3-multi-focal)|Subjects that were dispensed the Test lens (filcon II 3-multi-focal) in either the first or second period of the study.
68772|NCT02147093|O1|Outcome|Control (Filcon II 3-sphere)|Subjects that were dispensed the Control lens (filcon II 3-sphere) in either the first or second period of the study.
68773|NCT02147093|E2|Reported Event|Test (Filcon II 3-multi-focal)|Subjects that were dispensed the Test lens (filcon II 3-multi-focal) in either the first or second period of the study.
68774|NCT02147093|E1|Reported Event|Control (Filcon II 3-sphere)|Subjects that were dispensed the Control lens (filcon II 3-sphere) in either the first or second period of the study.
68775|NCT02146599|B1|Baseline|Pseudophakic|Administration of patient self assessment
68776|NCT02146599|P1|Participant Flow|Pseudophakic|Administration of patient self assessment
68777|NCT02146599|O1|Outcome|Pseudophakic|Administration of patient self assessment
68778|NCT02146599|E1|Reported Event|Pseudophakic|Administration of patient self assessment
68779|NCT02146482|B3|Baseline|Total|Total of all reporting groups
68780|NCT02146482|B2|Baseline|Sit-stand Computer Workstation|"Given a sit-stand computer workstation to use at their place of work~Sit-stand computer workstation: A sit-stand computer workstation allows one to sit or stand throughout the day while maintaining continued use of one's computer."
68781|NCT02146482|B1|Baseline|Control|Did not receive an intervention during the active portion of the study (i.e. 12 weeks). After the active portion of the study, this group was given a sit-stand computer workstation.
68782|NCT02146482|P2|Participant Flow|Sit-stand Computer Workstation|"Given a sit-stand computer workstation to use at their place of work~Sit-stand computer workstation: A sit-stand computer workstation allows one to sit or stand throughout the day while maintaining continued use of one's computer."
68783|NCT02146482|P1|Participant Flow|Control|Did not receive an intervention during the active portion of the study (i.e. 12 weeks). After the active portion of the study, this group was given a sit-stand computer workstation.
68784|NCT02146482|O2|Outcome|Sit-stand Computer Workstation|"Given a sit-stand computer workstation to use at their place of work~Sit-stand computer workstation: A sit-stand computer workstation allows one to sit or stand throughout the day while maintaining continued use of one's computer."
68785|NCT02146482|O1|Outcome|Control|Did not receive an intervention during the active portion of the study (i.e. 12 weeks). After the active portion of the study, this group was given a sit-stand computer workstation.
68786|NCT02146482|E2|Reported Event|Sit-stand Computer Workstation|"Given a sit-stand computer workstation to use at their place of work~Sit-stand computer workstation: A sit-stand computer workstation allows one to sit or stand throughout the day while maintaining continued use of one's computer."
68787|NCT02146482|E1|Reported Event|Control|Did not receive an intervention during the active portion of the study (i.e. 12 weeks). After the active portion of the study, this group was given a sit-stand computer workstation.
68788|NCT02146352|B1|Baseline|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
68789|NCT02146352|P1|Participant Flow|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
68790|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
68791|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
68792|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
68793|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
68843|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68794|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
68795|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
68796|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
68797|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
68798|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
68799|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
68800|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
68801|NCT02146352|E1|Reported Event|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
68802|NCT02146326|B5|Baseline|Total|Total of all reporting groups
68803|NCT02146326|B4|Baseline|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68804|NCT02146326|B3|Baseline|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68805|NCT02146326|B2|Baseline|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68806|NCT02146326|B1|Baseline|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68807|NCT02146326|P4|Participant Flow|Motivational Interviewing-Clients|"Clients linked to staff randomized to the MI intervention:~Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months."
68808|NCT02146326|P3|Participant Flow|BREATHE-Clients|"Clients linked to staff randomized to the BREATHE intervention:~Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months."
68809|NCT02146326|P2|Participant Flow|Motivational Interviewing-Mental Health Care Staff|"Mental Health Care Staff randomized to the Motivational Interviewing (MI) intervention:~Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months."
68810|NCT02146326|P1|Participant Flow|BREATHE-Mental Health Care Staff|"Mental Health Care Staff randomized to the Burnout Reduction: Enhanced Awareness, Tools, Handouts, and Education (BREATHE) intervention:~Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months."
68811|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68812|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68813|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68814|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68815|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68816|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68817|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68818|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68819|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68820|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68821|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68822|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68823|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68824|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68825|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68826|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68827|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68828|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68829|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68830|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68831|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68832|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68833|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68834|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68835|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68836|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68837|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68838|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68839|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68840|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68841|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68842|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68844|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68845|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68846|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68847|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68848|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68849|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68850|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68851|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68852|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68853|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68854|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68855|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68856|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68857|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68858|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68859|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68860|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68861|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68862|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68863|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68864|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68865|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68866|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68867|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention Clients: were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68868|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
69005|NCT02145676|P2|Participant Flow|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
68869|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68870|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68871|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68872|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68873|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68874|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68875|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68876|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68877|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68878|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68879|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68880|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68881|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68882|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68883|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68884|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68885|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68886|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68887|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68888|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68889|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68890|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68891|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68892|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68893|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68894|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68895|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention Clients: were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68896|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68897|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68898|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68899|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68900|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68901|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68902|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68903|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68904|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68905|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68906|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68907|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68908|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68909|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68910|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68911|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68912|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68913|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68914|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68915|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68916|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68917|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68918|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68919|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68920|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68921|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68922|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68923|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68924|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68925|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68926|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68927|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68928|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68929|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68930|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68931|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|"Clients linked to staff randomized to the MI intervention:~Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months"
68932|NCT02146326|O3|Outcome|BREATHE-Clients|"Clients linked to staff randomized to the BREATHE intervention:~Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months"
68933|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|"Mental Health Care Staff randomized to the MI intervention:~Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months."
68934|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|"Mental Health Care Staff randomized to the BREATHE intervention:~Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months."
68935|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68936|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68937|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68938|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68939|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68940|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68941|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68942|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68943|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
69087|NCT02145299|B3|Baseline|Total|Total of all reporting groups
68944|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68945|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68946|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68947|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68948|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68949|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68950|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68951|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68952|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68953|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68954|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68955|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68956|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68957|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68958|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68959|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68960|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68961|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68962|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68963|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68964|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68965|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68966|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68967|NCT02146326|E4|Reported Event|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
68968|NCT02146326|E3|Reported Event|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
69467|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
68969|NCT02146326|E2|Reported Event|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68970|NCT02146326|E1|Reported Event|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
68971|NCT02146248|B1|Baseline|HSG Studies|"Women will be given combined oral contraceptives and Depo-medroxyprogesterone acetate (DepoProvera®).~2 HSG studies will be done prior to hormonal treatment, 1 after the pill treatment, and depending on whether the tubes appear patent, 1 more after the depoProvera treatment, and a final HSG after another 2 weeks on the pill.~Combined oral contraceptive: combined oral contraceptive pill will be dosed continuously for 30 days without cycle interruption~DepoProvera: injectable hormonal contraceptive"
68972|NCT02146248|P1|Participant Flow|HSG Studies|"Women will be given combined oral contraceptives and Depo-medroxyprogesterone acetate (DepoProvera®).~2 HSG studies will be done prior to hormonal treatment, 1 after the pill treatment, and depending on whether the tubes appear patent, 1 more after the depoProvera treatment, and a final HSG after another 2 weeks on the pill.~Combined oral contraceptive: combined oral contraceptive pill will be dosed continuously for 30 days without cycle interruption~DepoProvera: injectable hormonal contraceptive"
68973|NCT02146248|O1|Outcome|HSG 5|post DMPA OC HSG
68974|NCT02146248|O1|Outcome|HSG 4|DMPA HSG
68975|NCT02146248|O1|Outcome|HSG 3|OC HSG
68976|NCT02146248|O1|Outcome|Tubal Patency Change|Change in tubal patency after OC treatment
68977|NCT02146248|O1|Outcome|Follicular Phase HSG|
68978|NCT02146248|E1|Reported Event|HSG Studies|"Women will be given combined oral contraceptives and Depo-medroxyprogesterone acetate (DepoProvera®).~2 HSG studies will be done prior to hormonal treatment, 1 after the pill treatment, and depending on whether the tubes appear patent, 1 more after the depoProvera treatment, and a final HSG after another 2 weeks on the pill.~Combined oral contraceptive: combined oral contraceptive pill will be dosed continuously for 30 days without cycle interruption~DepoProvera: injectable hormonal contraceptive"
68979|NCT02146105|B1|Baseline|Yoga For Knee Osteoarthritis|"An tailored arthritis-specific yoga program for women with knee osteoarthritis with the aim of increasing leg strength and alleviating knee pain related to the disease.~Yoga For Knee Osteoarthritis: Yoga program specifically for women with knee osteoarthritis."
68980|NCT02146105|P1|Participant Flow|Yoga Intervention|Participants completed a yoga strengthening program designed for knee osteoarthritis (OA). This program was taught by a certified yoga instructor who was trained to deliver the strengthening program. Participants were asked to attend 3 classes per week for 12 weeks. Each class was 1 hour in duration.
68981|NCT02146105|O1|Outcome|Yoga For Knee Osteoarthritis|"An tailored arthritis-specific yoga program for women with knee osteoarthritis with the aim of increasing leg strength and alleviating knee pain related to the disease.~Yoga For Knee Osteoarthritis: Yoga program specifically for women with knee osteoarthritis."
68982|NCT02146105|E1|Reported Event|Yoga For Knee Osteoarthritis|"An tailored arthritis-specific yoga program for women with knee osteoarthritis with the aim of increasing leg strength and alleviating knee pain related to the disease.~Yoga For Knee Osteoarthritis: Yoga program specifically for women with knee osteoarthritis."
68983|NCT02146001|B3|Baseline|Total|Total of all reporting groups
68984|NCT02146001|B2|Baseline|Sit Less|Targeting 1 hour less of sedentary time per day
68985|NCT02146001|B1|Baseline|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
68986|NCT02146001|P2|Participant Flow|Sit Less|Targeting 1 hour less of sedentary time per day
68987|NCT02146001|P1|Participant Flow|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
68988|NCT02146001|O2|Outcome|Sit Less|Targeting 1 hour less of sedentary time per day
68989|NCT02146001|O1|Outcome|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
68990|NCT02146001|O2|Outcome|Sit Less|Targeting 1 hour less of sedentary time per day
68991|NCT02146001|O1|Outcome|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
68992|NCT02146001|O2|Outcome|Sit Less|Targeting 1 hour less of sedentary time per day
68993|NCT02146001|O1|Outcome|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
68994|NCT02146001|E2|Reported Event|Sit Less|Targeting 1 hour less of sedentary time per day
68995|NCT02146001|E1|Reported Event|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
68996|NCT02145754|B1|Baseline|MKP Media Versus BSK-H Media|"cultivation of Borrelia burgdorferi sensu lato (from skin specimens obtained from erythema migrans patients) in MKP media and in BSK-H media~MKP media versus BSK-H media"
68997|NCT02145754|P1|Participant Flow|MKP Media Versus BSK-H Media|"cultivation of Borrelia burgdorferi sensu lato (from skin specimens obtained from erythema migrans patients) in MKP media and in BSK-h media~MKP media versus BSK-H media"
68998|NCT02145754|O1|Outcome|MKP Media Versus BSK-H Media|"cultivation of Borrelia burgdorferi sensu lato (from skin specimens obtained from erythema migrans patients) in MKP media and in BSK-H media~MKP media versus BSK-H media"
68999|NCT02145754|E1|Reported Event|MKP Media Versus BSK-h Media|"cultivation of Borrelia burgdorferi sensu lato (from skin specimens obtained from erythema migrans patients) in MKP media and in BSK-H media~MKP media versus BSK-H media"
69000|NCT02145676|B4|Baseline|Total|Total of all reporting groups
69001|NCT02145676|B3|Baseline|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
69002|NCT02145676|B2|Baseline|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
69003|NCT02145676|B1|Baseline|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
69004|NCT02145676|P3|Participant Flow|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
69618|NCT02141997|E4|Reported Event|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
69006|NCT02145676|P1|Participant Flow|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
69007|NCT02145676|O3|Outcome|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
69008|NCT02145676|O2|Outcome|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
69009|NCT02145676|O1|Outcome|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
69010|NCT02145676|O3|Outcome|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
69011|NCT02145676|O2|Outcome|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
69012|NCT02145676|O1|Outcome|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
69013|NCT02145676|O3|Outcome|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
69014|NCT02145676|O2|Outcome|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
69015|NCT02145676|O1|Outcome|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
69016|NCT02145676|O3|Outcome|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
69017|NCT02145676|O2|Outcome|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
69018|NCT02145676|O1|Outcome|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
69019|NCT02145676|O3|Outcome|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
69020|NCT02145676|O2|Outcome|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
69021|NCT02145676|O1|Outcome|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
69022|NCT02145676|O3|Outcome|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
69023|NCT02145676|O2|Outcome|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
69024|NCT02145676|O1|Outcome|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
69025|NCT02145676|E3|Reported Event|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
69026|NCT02145676|E2|Reported Event|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
69027|NCT02145676|E1|Reported Event|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
69028|NCT02145468|B3|Baseline|Total|Total of all reporting groups
69029|NCT02145468|B2|Baseline|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69030|NCT02145468|B1|Baseline|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69031|NCT02145468|P2|Participant Flow|Losmapimod 7.5 Mllligrms BID|Participants received losmapimod 7.5 milligrams (mg) tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69032|NCT02145468|P1|Participant Flow|Placebo|Participants received losmapimod matching placebo tablets via oral route, twice daily (BID), according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69033|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69034|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69035|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69036|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69037|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69038|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69039|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69040|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69620|NCT02141997|E2|Reported Event|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
69041|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69042|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69043|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69044|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69045|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69046|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69047|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69048|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69049|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69050|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69051|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69052|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69053|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69054|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69055|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69056|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69057|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69058|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69059|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69060|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69061|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69062|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69063|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69064|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69065|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69066|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69067|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69068|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69069|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69070|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69071|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69072|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69073|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69074|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69075|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69076|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69077|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69078|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69079|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69080|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69081|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69082|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69083|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69084|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69085|NCT02145468|E2|Reported Event|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69086|NCT02145468|E1|Reported Event|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
69088|NCT02145299|B2|Baseline|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
69089|NCT02145299|B1|Baseline|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
69090|NCT02145299|P2|Participant Flow|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
69091|NCT02145299|P1|Participant Flow|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
69092|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
69093|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
69094|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
69095|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
69096|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
69097|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
69098|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
69123|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
69099|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
69100|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
69101|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
69102|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
69103|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
69104|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
69105|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
69106|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
69107|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
69108|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
69109|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
69110|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
69111|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
69112|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
69113|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
69114|NCT02145299|E2|Reported Event|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
69115|NCT02145299|E1|Reported Event|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
69116|NCT02145156|B4|Baseline|Total|Total of all reporting groups
69117|NCT02145156|B3|Baseline|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
69118|NCT02145156|B2|Baseline|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
69119|NCT02145156|B1|Baseline|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
69120|NCT02145156|P3|Participant Flow|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
69121|NCT02145156|P2|Participant Flow|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
69122|NCT02145156|P1|Participant Flow|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
69206|NCT02144220|P1|Participant Flow|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
69124|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
69125|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
69126|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
69127|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
69128|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
69129|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
69130|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
69131|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
69132|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
69133|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
69134|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
69135|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
69136|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
69151|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
69137|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
69138|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
69139|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
69140|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
69141|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
69142|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
69143|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
69144|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
69145|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
69146|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
69147|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
69148|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
69149|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
69150|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
69152|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
69153|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
69154|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
69155|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
69156|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
69157|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
69158|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
69159|NCT02145156|E3|Reported Event|Usual Care|"Intervention: Survey-only. Intervention: survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
69160|NCT02145156|E2|Reported Event|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
69161|NCT02145156|E1|Reported Event|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
69162|NCT02144519|B3|Baseline|Total|Total of all reporting groups
69163|NCT02144519|B2|Baseline|Immediate Intervention|"This arm receives the Healthy Eating and Physical Activity intervention in ASPs intervention immediately for a full year before the delayed intervention begins. This arm gets the intervention and support for two years.~Healthy Eating and Physical Activity: Create partnerships with ASPs to help facilitate changes in programming to meet the National Afterschool Alliance's HEPA Standards."
69164|NCT02144519|B1|Baseline|Delayed Intervention|"This arm served as a comparison group for the first year and received the Healthy Eating and Physical Activity intervention in year 3 along with arm 1.~Healthy Eating and Physical Activity: Create partnerships with ASPs to help facilitate changes in programming to meet the National Afterschool Alliance's HEPA Standards."
69165|NCT02144519|P2|Participant Flow|Delayed Intervention|Over the 3 year project, this arm serves as the no treatment control/comparison group for year 1 and 2 (2 years of baseline) and receives the Healthy Eating and Physical Activity intervention in year 3 for a total of 1 year.
69166|NCT02144519|P1|Participant Flow|Immediate Intervention|Over the 3 year project, this arm receives the Healthy Eating and Physical Activity intervention after year 1 (baseline) for a total of 2 years (year 2 and 3).
69167|NCT02144519|O2|Outcome|Delayed Intervention|Over the 3 year project, this arm serves as the no treatment control/comparison group for year 1 and 2 (2 years of baseline) and receives the Healthy Eating and Physical Activity intervention in year 3 for a total of 1 year.
69168|NCT02144519|O1|Outcome|Immediate Intervention|Over the 3 year project, this arm receives the Healthy Eating and Physical Activity intervention after year 1 (baseline) for a total of 2 years (year 2 and 3).
69169|NCT02144519|O2|Outcome|Delayed Intervention|Over the 3 year project, this arm serves as the no treatment control/comparison group for year 1 and 2 (2 years of baseline) and receives the Healthy Eating and Physical Activity intervention in year 3 for a total of 1 year.
69170|NCT02144519|O1|Outcome|Immediate Intervention|Over the 3 year project, this arm receives the Healthy Eating and Physical Activity intervention after year 1 (baseline) for a total of 2 years (year 2 and 3).
69171|NCT02144519|E2|Reported Event|Immediate Intervention|Over the 3 year project, this arm receives the Healthy Eating and Physical Activity intervention after year 1 (baseline) for a total of 2 years (year 2 and 3).
69172|NCT02144519|E1|Reported Event|Delayed Intervention|Over the 3 year project, this arm serves as the no treatment control/comparison group for year 1 and 2 (2 years of baseline) and receives the Healthy Eating and Physical Activity intervention in year 3 for a total of 1 year.
69173|NCT02144337|B3|Baseline|Total|Total of all reporting groups
69174|NCT02144337|B2|Baseline|Normal Daily Activity|Treatment as usual: children asked to continue normal daily activity as usual.
69175|NCT02144337|B1|Baseline|Steps To Active Kids (STAK) Programme|"6 week Steps To Active Kids (STAK) physical activity programme (combined supervised and home-based physical activity).~Steps To Active Kids (STAK) Programme: 6 week programme of combined supervised and home-based (non-supervised) physical activity."
69176|NCT02144337|P2|Participant Flow|Control Group|Control group. Children in the Control group are asked to continue normal daily activities.
69177|NCT02144337|P1|Participant Flow|Intervention Group|6 week Steps To Active Kids (STAK) programme includes: StreetDance DVD designed to be completed at home (4 weeks in total). A dance routine is taught over 4 weeks with new elements introduced each day. Activity diary aims to encourage children to record daily activities in a logbook and to educate children about physical activity. Step counter: Children are given a pedometer and encouraged to record steps in the activity diary and to set personal goals to increase their steps. Weekly group activity sessions for 4 – 6 weeks. Involve a circuit of activity stations varying in intensity. The group sessions are designed to be fun and non-competitive. Children can record their scores at each station and monitor their own progress.
69178|NCT02144337|O1|Outcome|Overall Study Group Sample|Intervention and control group combined
69179|NCT02144337|O1|Outcome|Intervention Group|Steps To Active Kids (STAK) programme
69180|NCT02144337|O2|Outcome|Control Group|No intervention
69181|NCT02144337|O1|Outcome|Intervention Group|Steps To Active Kids (STAK) programme
69182|NCT02144337|O2|Outcome|Control Group|No intervention
69183|NCT02144337|O1|Outcome|Intervention Group|Steps To Active Kids (STAK) programme
69184|NCT02144337|E2|Reported Event|Normal Daily Activity|Treatment as usual: children asked to continue normal daily activity as usual.
69185|NCT02144337|E1|Reported Event|Steps To Active Kids (STAK) Programme|"6 week Steps To Active Kids (STAK) physical activity programme (combined supervised and home-based physical activity).~Steps To Active Kids (STAK) Programme: 6 week programme of combined supervised and home-based (non-supervised) physical activity."
69186|NCT02144259|B4|Baseline|Total|Total of all reporting groups
69187|NCT02144259|B3|Baseline|Control Group|Subjects selecting their own method of contraception or no contraception.
69188|NCT02144259|B2|Baseline|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.~Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
69189|NCT02144259|B1|Baseline|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.~DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
69190|NCT02144259|P3|Participant Flow|Control Group|Subjects selecting their own method of contraception or no contraception.
69191|NCT02144259|P2|Participant Flow|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.~Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
69192|NCT02144259|P1|Participant Flow|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.~DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
69193|NCT02144259|O3|Outcome|Control Group|Subjects selecting their own method of contraception or no contraception.
69194|NCT02144259|O2|Outcome|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.~Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
69195|NCT02144259|O1|Outcome|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.~DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
69196|NCT02144259|O3|Outcome|Control Group|Subjects selecting their own method of contraception or no contraception.
69197|NCT02144259|O2|Outcome|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.~Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
69198|NCT02144259|O1|Outcome|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.~DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
69199|NCT02144259|O3|Outcome|Control Group|Subjects selecting their own method of contraception or no contraception.
69200|NCT02144259|O2|Outcome|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.~Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
69201|NCT02144259|O1|Outcome|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.~DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
69202|NCT02144259|E3|Reported Event|Control Group|Subjects selecting their own method of contraception or no contraception.
69203|NCT02144259|E2|Reported Event|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.~Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
69204|NCT02144259|E1|Reported Event|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.~DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
69205|NCT02144220|B1|Baseline|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
69207|NCT02144220|O1|Outcome|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
69208|NCT02144220|O1|Outcome|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
69209|NCT02144220|O1|Outcome|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
69210|NCT02144220|O1|Outcome|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
69211|NCT02144220|O1|Outcome|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
69212|NCT02144220|E1|Reported Event|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
69213|NCT02144012|B3|Baseline|Total|Total of all reporting groups
69214|NCT02144012|B2|Baseline|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
69215|NCT02144012|B1|Baseline|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
69216|NCT02144012|P2|Participant Flow|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
69217|NCT02144012|P1|Participant Flow|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
69218|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
69219|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
69220|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
69221|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
69222|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
69223|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
69224|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
69225|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
69454|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
69226|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
69227|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
69228|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
69229|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
69230|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
69231|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
69232|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
69233|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
69234|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
69235|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
69236|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
69237|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
69238|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
69239|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
69240|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
69241|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
69242|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
69243|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
69244|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
69245|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
69246|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
69247|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
69248|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
69249|NCT02144012|E2|Reported Event|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
69250|NCT02144012|E1|Reported Event|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
69251|NCT02143947|B3|Baseline|Total|Total of all reporting groups
69252|NCT02143947|B2|Baseline|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses~Maximal Arch Subtalar Stabilization: Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
69253|NCT02143947|B1|Baseline|Full Contact Orthosis|"Full Contact Orthosis~Full Contact Orthosis: The Full Contact orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
69254|NCT02143947|P2|Participant Flow|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses~Maximal Arch Subtalar Stabilization: The in-shoe orthosis is a custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
69255|NCT02143947|P1|Participant Flow|Full Contact Orthosis|"Full Contact Orthosis~Full Contact Orthosis: The full contact in-shoe orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
69256|NCT02143947|O2|Outcome|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses~Maximal Arch Subtalar Stabilization: Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
69257|NCT02143947|O1|Outcome|Full Contact Orthosis|"Full Contact Orthosis~Full Contact Orthosis: The Full Contact orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
69258|NCT02143947|O2|Outcome|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses~Maximal Arch Subtalar Stabilization: Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
69259|NCT02143947|O1|Outcome|Full Contact Orthosis|"Full Contact Orthosis~Full Contact Orthosis: The Full Contact orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
69455|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
69260|NCT02143947|O2|Outcome|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses~Maximal Arch Subtalar Stabilization: The in-shoe orthosis is a custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
69261|NCT02143947|O1|Outcome|Full Contact Orthosis|"Full Contact Orthosis~Full Contact Orthosis: The full contact in-shoe orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
69262|NCT02143947|O2|Outcome|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses~Maximal Arch Subtalar Stabilization: Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
69263|NCT02143947|O1|Outcome|Full Contact Orthosis|"Full Contact Orthosis~Full Contact Orthosis: The Full Contact orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
69264|NCT02143947|E2|Reported Event|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses~Maximal Arch Subtalar Stabilization: Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
69265|NCT02143947|E1|Reported Event|Full Contact Orthosis|"Full Contact Orthosis~Full Contact Orthosis: The Full Contact orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
69266|NCT02143583|B4|Baseline|Total|Total of all reporting groups
69267|NCT02143583|B3|Baseline|Placebo|Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
69268|NCT02143583|B2|Baseline|AllerT 50 μg|patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T
69269|NCT02143583|B1|Baseline|AllerT 100 μg|patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T
69270|NCT02143583|P3|Participant Flow|Placebo|Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
69271|NCT02143583|P2|Participant Flow|AllerT 50 μg|patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T
69272|NCT02143583|P1|Participant Flow|AllerT 100 μg|patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T
69273|NCT02143583|O3|Outcome|Placebo|Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
69274|NCT02143583|O2|Outcome|AllerT 50 μg|patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T
69275|NCT02143583|O1|Outcome|AllerT 100 μg|patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T
69276|NCT02143583|O3|Outcome|Placebo|Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
69277|NCT02143583|O2|Outcome|AllerT 50 μg|patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T
69278|NCT02143583|O1|Outcome|AllerT 100 μg|patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T
69279|NCT02143583|E3|Reported Event|Placebo|Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
69280|NCT02143583|E2|Reported Event|AllerT 50 μg|patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T
69281|NCT02143583|E1|Reported Event|AllerT 100 μg|patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T
69282|NCT02143141|B3|Baseline|Total|Total of all reporting groups
69283|NCT02143141|B2|Baseline|no Duramorph|"no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively~placebo: placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching."
69284|NCT02143141|B1|Baseline|Duramorph|"duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours~duramorph: duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching."
69285|NCT02143141|P2|Participant Flow|no Duramorph|"no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively~placebo: placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching."
69286|NCT02143141|P1|Participant Flow|Duramorph|"duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours~duramorph: duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching."
69287|NCT02143141|O2|Outcome|no Duramorph|"no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively~placebo: placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching."
69288|NCT02143141|O1|Outcome|Duramorph|"duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours~duramorph: duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching."
69289|NCT02143141|O2|Outcome|no Duramorph|"no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively~placebo: placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching."
69456|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
69290|NCT02143141|O1|Outcome|Duramorph|"duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours~duramorph: duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching."
69291|NCT02143141|O2|Outcome|no Duramorph|"no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively~placebo: placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching."
69292|NCT02143141|O1|Outcome|Duramorph|"duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours~duramorph: duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching."
69293|NCT02143141|E2|Reported Event|no Duramorph|"no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively~placebo: placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching."
69294|NCT02143141|E1|Reported Event|Duramorph|"duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours~duramorph: duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching."
69295|NCT02142738|B3|Baseline|Total|Total of all reporting groups
69296|NCT02142738|B2|Baseline|SOC Chemotherapy|Participants received SOC platinum-based chemotherapy, administered as IV infusion. If PD occurred, participants may have been able to receive pembrolizumab on Day 1 of each 21-day cycle for the remainder of the study or until documented PD or participant discontinuation.
69297|NCT02142738|B1|Baseline|Pembrolizumab|Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.
69298|NCT02142738|P2|Participant Flow|SOC Chemotherapy|Participants received SOC platinum-based chemotherapy, administered as IV infusion. If PD occurred, participants may have been able to receive pembrolizumab on Day 1 of each 21-day cycle for the remainder of the study or until documented PD or participant discontinuation.
69299|NCT02142738|P1|Participant Flow|Pembrolizumab|Participants received pembrolizumab 200 mg, administered as intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented progressive disease (PD) or participant discontinuation.
69300|NCT02142738|O2|Outcome|SOC Chemotherapy|Participants received SOC platinum-based chemotherapy, administered as IV infusion. If PD occurred, participants may have been able to receive pembrolizumab on Day 1 of each 21-day cycle for the remainder of the study or until documented PD or participant discontinuation.
69301|NCT02142738|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.
69302|NCT02142738|O2|Outcome|SOC Chemotherapy|Participants received SOC platinum-based chemotherapy, administered as IV infusion. If PD occurred, participants may have been able to receive pembrolizumab on Day 1 of each 21-day cycle for the remainder of the study or until documented PD or participant discontinuation.
69303|NCT02142738|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.
69304|NCT02142738|O2|Outcome|SOC Chemotherapy|Participants received SOC platinum-based chemotherapy, administered as IV infusion. If PD occurred, participants may have been able to receive pembrolizumab on Day 1 of each 21-day cycle for the remainder of the study or until documented PD or participant discontinuation.
69305|NCT02142738|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.
69306|NCT02142738|E2|Reported Event|SOC Chemotherapy|Participants received SOC platinum-based chemotherapy, administered as IV infusion. If PD occurred, participants may have been able to receive pembrolizumab on Day 1 of each 21-day cycle for the remainder of the study or until documented PD or participant discontinuation.
69307|NCT02142738|E1|Reported Event|Pembrolizumab|Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.
69308|NCT02142712|B4|Baseline|Total|Total of all reporting groups
69309|NCT02142712|B3|Baseline|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
69310|NCT02142712|B2|Baseline|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
69311|NCT02142712|B1|Baseline|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
69312|NCT02142712|P4|Participant Flow|Dextromethorphan|Dextromethorphan- 60 mg QID orally (maximum dose of 240 mg/day) for 2 days (total of 4 doses) + current standard of care
69313|NCT02142712|P3|Participant Flow|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
69314|NCT02142712|P2|Participant Flow|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
69315|NCT02142712|P1|Participant Flow|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
69316|NCT02142712|O3|Outcome|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
69317|NCT02142712|O2|Outcome|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
69457|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
69318|NCT02142712|O1|Outcome|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
69319|NCT02142712|O3|Outcome|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
69320|NCT02142712|O2|Outcome|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
69321|NCT02142712|O1|Outcome|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
69322|NCT02142712|O3|Outcome|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
69323|NCT02142712|O2|Outcome|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care.
69324|NCT02142712|O1|Outcome|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
69325|NCT02142712|O3|Outcome|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
69326|NCT02142712|O2|Outcome|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care.
69327|NCT02142712|O1|Outcome|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
69328|NCT02142712|O3|Outcome|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
69329|NCT02142712|O2|Outcome|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
69330|NCT02142712|O1|Outcome|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
69331|NCT02142712|E3|Reported Event|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
69332|NCT02142712|E2|Reported Event|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
69333|NCT02142712|E1|Reported Event|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
69334|NCT02142504|B4|Baseline|Total|Total of all reporting groups
69335|NCT02142504|B3|Baseline|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69336|NCT02142504|B2|Baseline|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69337|NCT02142504|B1|Baseline|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69338|NCT02142504|P3|Participant Flow|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69339|NCT02142504|P2|Participant Flow|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69340|NCT02142504|P1|Participant Flow|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69341|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69342|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69343|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69344|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69458|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
69345|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69346|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69347|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69348|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69349|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69350|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69351|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69352|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69353|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69354|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69355|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69356|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69357|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69358|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69359|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69360|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69361|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69362|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69459|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
69460|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
69363|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69364|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69365|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69366|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69367|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69368|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69369|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69370|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69371|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69372|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69373|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69374|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69375|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69376|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69377|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69378|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69379|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69380|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69461|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
69462|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
69381|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69382|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69383|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69384|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69385|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69386|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69387|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69388|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69389|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69390|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69391|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69392|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69393|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69394|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69395|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69396|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69397|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69398|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69463|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
69464|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
69399|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69400|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69401|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69402|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69403|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69404|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69405|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69406|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69407|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69408|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69409|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69410|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69411|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69412|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69413|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69414|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69415|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69416|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69465|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
69466|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
69417|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69418|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69419|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69420|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69421|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69422|NCT02142504|E3|Reported Event|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
69423|NCT02142504|E2|Reported Event|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
69424|NCT02142504|E1|Reported Event|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
69425|NCT02142361|B1|Baseline|Overall Study Group|All participants were habitual wearers of hydrogel toric lenses (omafilcon A, ocufilcon D or methafilcon B), and refitted with silicone hydrogel toric lens (enfilcon A)
69426|NCT02142361|P3|Participant Flow|Methafilcon B/Enfilcon A|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69427|NCT02142361|P2|Participant Flow|Ocufilcon D/Enfilcon A|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69428|NCT02142361|P1|Participant Flow|Omafilcon A/Enfilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69429|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
69430|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
69431|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
69432|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
69433|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
69434|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
69435|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
69436|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
69437|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
69438|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
69439|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
69440|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
69441|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
69442|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
69443|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
69444|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
69445|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
69446|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
69447|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
69448|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
69449|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
69450|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
69451|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
69452|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
69453|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
69468|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
69469|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
69470|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
69471|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
69472|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
69473|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
69474|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at 1 week.
69475|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69476|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69477|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69478|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69479|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69480|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69481|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69482|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69483|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69484|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69485|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69486|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69487|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69488|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69489|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69490|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69491|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69492|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69493|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69494|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69495|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69496|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69497|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69498|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69499|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69500|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69501|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69502|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69503|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69504|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69505|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69506|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69507|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69508|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69509|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69510|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69511|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69512|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69513|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69514|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69515|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69516|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69517|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69518|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69519|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69520|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69521|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69522|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
69523|NCT02142361|E3|Reported Event|Methafilcon B|"Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.~enfilcon A: Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation."
69524|NCT02142361|E2|Reported Event|Ocufilcon D|"Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.~enfilcon A: Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation."
69525|NCT02142361|E1|Reported Event|Omafilcon A|"Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.~enfilcon A: Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation."
69526|NCT02142153|B11|Baseline|Total|Total of all reporting groups
69527|NCT02142153|B10|Baseline|Placebo 4 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
69528|NCT02142153|B9|Baseline|F901318 4 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
69529|NCT02142153|B8|Baseline|Placebo 3 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
69530|NCT02142153|B7|Baseline|F901318 3 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
69531|NCT02142153|B6|Baseline|Placebo 1.5 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
69532|NCT02142153|B5|Baseline|F901318 1.5 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
69533|NCT02142153|B4|Baseline|Placebo 0.75 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
69534|NCT02142153|B3|Baseline|F901318 0.75 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
69535|NCT02142153|B2|Baseline|0.25 mg/kg Placebo|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
69536|NCT02142153|B1|Baseline|F901318 0.25 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
69537|NCT02142153|P10|Participant Flow|Placebo 4 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
69538|NCT02142153|P9|Participant Flow|F901318 4 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
69539|NCT02142153|P8|Participant Flow|Placebo 3 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
69540|NCT02142153|P7|Participant Flow|F901318 3 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
69541|NCT02142153|P6|Participant Flow|Placebo 1.5 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
69542|NCT02142153|P5|Participant Flow|F901318 1.5 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
69543|NCT02142153|P4|Participant Flow|Placebo 0.75 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
69544|NCT02142153|P3|Participant Flow|F901318 0.75 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
69545|NCT02142153|P2|Participant Flow|0.25 mg/kg Placebo|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
69546|NCT02142153|P1|Participant Flow|F901318 0.25 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
69547|NCT02142153|O10|Outcome|Placebo 4 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of clinically sign significant safety lab and ECG abnormalities No clinically significant findings"
69548|NCT02142153|O9|Outcome|F901318 4 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of clinically significant safety laboratory abnormalities and ECG abnormalities.~No clinically significant findings"
69549|NCT02142153|O8|Outcome|Placebo 3 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of clinically sign significant safety lab and ECG abnormalities No clinically significant findings"
69550|NCT02142153|O7|Outcome|F901318 3 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of clinically significant safety laboratory abnormalities and ECG abnormalities.~No clinically significant findings"
69551|NCT02142153|O6|Outcome|Placebo 1.5 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of clinically sign significant safety lab and ECG abnormalities No clinically significant findings"
69552|NCT02142153|O5|Outcome|F901318 1.5 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of clinically significant safety laboratory abnormalities and ECG abnormalities.~No clinically significant findings"
69553|NCT02142153|O4|Outcome|Placebo 0.75 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of clinically sign significant safety lab and ECG abnormalities No clinically significant findings"
69554|NCT02142153|O3|Outcome|F901318 0.75 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of clinically significant safety laboratory abnormalities and ECG abnormalities.~No clinically significant findings"
69555|NCT02142153|O2|Outcome|0.25 mg/kg Placebo|"Single intravenous infusion over 4 hours~Placebo: Comparison of clinically significant safety lab and ECG abnormalities No clinically significant findings"
69556|NCT02142153|O1|Outcome|F901318 0.25 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of clinically significant safety laboratory abnormalities and ECG abnormalities.~No clinically significant findings"
69557|NCT02142153|O10|Outcome|Placebo 4 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
69558|NCT02142153|O9|Outcome|F901318 4 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
69559|NCT02142153|O8|Outcome|Placebo 3 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
69560|NCT02142153|O7|Outcome|F901318 3 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
69561|NCT02142153|O6|Outcome|Placebo 1.5 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
69562|NCT02142153|O5|Outcome|F901318 1.5 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
69563|NCT02142153|O4|Outcome|Placebo 0.75 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
69564|NCT02142153|O3|Outcome|F901318 0.75 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
69565|NCT02142153|O2|Outcome|0.25 mg/kg Placebo|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
69619|NCT02141997|E3|Reported Event|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
69566|NCT02142153|O1|Outcome|F901318 0.25 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
69567|NCT02142153|E10|Reported Event|Placebo 4 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
69568|NCT02142153|E9|Reported Event|F901318 4 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
69569|NCT02142153|E8|Reported Event|Placebo 3 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
69570|NCT02142153|E7|Reported Event|F901318 3 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
69571|NCT02142153|E6|Reported Event|Placebo 1.5 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
69572|NCT02142153|E5|Reported Event|F901318 1.5 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
69573|NCT02142153|E4|Reported Event|Placebo 0.75 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
69574|NCT02142153|E3|Reported Event|F901318 0.75 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
69575|NCT02142153|E2|Reported Event|0.25 mg/kg Placebo|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
69576|NCT02142153|E1|Reported Event|F901318 0.25 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
69577|NCT02141997|B5|Baseline|Total|Total of all reporting groups
69578|NCT02141997|B4|Baseline|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
69579|NCT02141997|B3|Baseline|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
69580|NCT02141997|B2|Baseline|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
69581|NCT02141997|B1|Baseline|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
69582|NCT02141997|P4|Participant Flow|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
69583|NCT02141997|P3|Participant Flow|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
69584|NCT02141997|P2|Participant Flow|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
69585|NCT02141997|P1|Participant Flow|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
69586|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
69587|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
69588|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
69589|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
69590|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
69591|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
69592|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
69593|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
69594|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
69595|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
69596|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
69597|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
69598|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
69599|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
69600|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
69601|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
69602|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
69603|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
69604|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
69605|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
69606|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
69607|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
69608|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
69609|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
69610|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
69611|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
69612|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
69613|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
69614|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
69615|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
69616|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
69617|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
69621|NCT02141997|E1|Reported Event|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
69622|NCT02141984|B1|Baseline|Patients With Polyarticular JIA or ERA|Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
69623|NCT02141984|P1|Participant Flow|Patients With Polyarticular JIA or ERA|Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
69624|NCT02141984|O1|Outcome|Patients With Polyarticular JIA or ERA|Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
69625|NCT02141984|O1|Outcome|Patients With Polyarticular JIA or ERA|Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
69626|NCT02141984|O1|Outcome|Patients With Polyarticular JIA or ERA|Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
69627|NCT02141984|O1|Outcome|Patients With Polyarticular JIA or ERA|Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
69628|NCT02141984|E1|Reported Event|Patients With Polyarticular JIA or ERA|Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
69629|NCT02141867|B1|Baseline|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery. Age 43.5 (SD 17.6) years, Male 1994 (50.8%)
69630|NCT02141867|P1|Participant Flow|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery
69631|NCT02141867|O1|Outcome|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery
69632|NCT02141867|O1|Outcome|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery
69633|NCT02141867|O1|Outcome|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery
69634|NCT02141867|O1|Outcome|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery
69635|NCT02141867|E1|Reported Event|Non Cardiac Surgery|Non cardiac surgery patients 16 years or older
69636|NCT02141854|B6|Baseline|Total|Total of all reporting groups
69637|NCT02141854|B5|Baseline|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69638|NCT02141854|B4|Baseline|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69639|NCT02141854|B3|Baseline|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69640|NCT02141854|B2|Baseline|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69641|NCT02141854|B1|Baseline|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69642|NCT02141854|P6|Participant Flow|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69643|NCT02141854|P5|Participant Flow|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69644|NCT02141854|P4|Participant Flow|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69645|NCT02141854|P3|Participant Flow|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69646|NCT02141854|P2|Participant Flow|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69732|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69647|NCT02141854|P1|Participant Flow|Fluticasone Propionate 50 mcg BID|All enrolled participants used single-blind fluticasone propionate multidose dry powder inhaler twice a day for a total daily dose of 100 mcg during the Run-In Period (14-21 days).
69648|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69649|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69650|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69651|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69652|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69653|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69654|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69655|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69656|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69657|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69658|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69659|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69660|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69661|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69662|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69733|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69734|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69663|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69664|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69665|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69666|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69667|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69668|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69669|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69670|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69671|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69672|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69673|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69674|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69675|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69676|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69677|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69678|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69679|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69680|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69681|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69682|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69683|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69684|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69685|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69686|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69687|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69688|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69689|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69690|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69691|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69692|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69693|NCT02141854|E5|Reported Event|Placebo|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69694|NCT02141854|E4|Reported Event|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69695|NCT02141854|E3|Reported Event|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69696|NCT02141854|E2|Reported Event|FS MDPI 200/12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69697|NCT02141854|E1|Reported Event|FS MDPI 100/12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
69698|NCT02141633|B3|Baseline|Total|Total of all reporting groups
69699|NCT02141633|B2|Baseline|Non-smokers|"echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
69700|NCT02141633|B1|Baseline|Smokers|"echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
69701|NCT02141633|P2|Participant Flow|Non-smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol~echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
69702|NCT02141633|P1|Participant Flow|Smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol.~echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
69703|NCT02141633|O2|Outcome|Non-smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol~echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
69704|NCT02141633|O1|Outcome|Smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol.~echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
69705|NCT02141633|O2|Outcome|Non-smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol~echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
69706|NCT02141633|O1|Outcome|Smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol.~echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
69707|NCT02141633|E2|Reported Event|Non-smokers|No AE or SAE had occurred
69708|NCT02141633|E1|Reported Event|Smokers|No AE or SAE had occurred
69709|NCT02141620|B1|Baseline|All Study Participants|All subjects who completed the study.
69710|NCT02141620|P2|Participant Flow|n-Acetylcysteine Then Placebo|Subjects were maintained on 2.4 g n-acetylcysteine for 7 days, then they were crossed over to placebo daily for 7 days.
69711|NCT02141620|P1|Participant Flow|Placebo Then n-Acetylcysteine|Subjects were maintained on placebo for 7 days, then they were crossed over to 2.4 g n-acetylcysteine daily for 7 days.
69712|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69713|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69714|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69715|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69716|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69717|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69718|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69719|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69720|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69721|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69722|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69723|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69724|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69725|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69726|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69727|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69728|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69729|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69730|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69731|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69735|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69736|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69737|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69738|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69739|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69740|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69741|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69742|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69743|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69744|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69745|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69746|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69747|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69748|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69749|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69750|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69751|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69752|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69753|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69754|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69755|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69756|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69757|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69758|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69759|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69760|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69761|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69762|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69763|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69764|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
69765|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
69766|NCT02141620|E2|Reported Event|n-Acetylcysteine Then Placebo|Subjects were maintained on 2.4 g n-acetylcysteine for 7 days, then they were crossed over to placebo daily for 7 days.
69767|NCT02141620|E1|Reported Event|Placebo Then n-Acetylcysteine|Subjects were maintained on placebo for 7 days, then they were crossed over to 2.4 g n-acetylcysteine daily for 7 days.
69768|NCT02141581|B4|Baseline|Total|Total of all reporting groups
69769|NCT02141581|B3|Baseline|Group C FluMist®|Participants in this group will be randomized to FluMist® administered intranasally.
69770|NCT02141581|B2|Baseline|Group B Fluzone® (ID)|Participants in this group will be randomized to Fluzone® administered intradermally (ID)
69771|NCT02141581|B1|Baseline|Group A Fluzone® (IM)|Participants in this group will be randomized to Fluzone® administered intramuscularly (IM)
69772|NCT02141581|P3|Participant Flow|Group C FluMist®|Participants in this group will be randomized to FluMist® administered intranasally.
69773|NCT02141581|P2|Participant Flow|Group B Fluzone® (ID)|Participants in this group will be randomized to Fluzone® administered intradermally (ID)
69774|NCT02141581|P1|Participant Flow|Group A Fluzone® (IM)|Participants in this group will be randomized to Fluzone® administered intramuscularly (IM)
69775|NCT02141581|O3|Outcome|Group C Flumist®|Participants in this group will be randomized to Flumist® administered intranasally.
69776|NCT02141581|O2|Outcome|Group B Fluzone® (ID)|Participants in this group will be randomized to Fluzone® administered intradermally (ID)
69777|NCT02141581|O1|Outcome|Group A Fluzone® (IM)|Participants in this group will be randomized to Fluzone® administered intramuscularly (IM)
69778|NCT02141581|O3|Outcome|Group C Flumist®|Participants in this group will be randomized to Flumist® administered intranasally.
69779|NCT02141581|O2|Outcome|Group B Fluzone® (ID)|Participants in this group will be randomized to Fluzone® administered intradermally (ID)
69780|NCT02141581|O1|Outcome|Group A Fluzone® (IM)|Participants in this group will be randomized to Fluzone® administered intramuscularly (IM)
69781|NCT02141581|E3|Reported Event|Group C FluMist®|Participants in this group will be randomized to FluMist® administered intranasally.
69782|NCT02141581|E2|Reported Event|Group B Fluzone® (ID)|Participants in this group will be randomized to Fluzone® administered intradermally (ID)
69783|NCT02141581|E1|Reported Event|Group A Fluzone® (IM)|Participants in this group will be randomized to Fluzone® administered intramuscularly (IM)
69784|NCT02141516|B4|Baseline|Total|Total of all reporting groups
69785|NCT02141516|B3|Baseline|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
69786|NCT02141516|B2|Baseline|Asplenia|Subjects aged ≥ 2 to ≤17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
69787|NCT02141516|B1|Baseline|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
69788|NCT02141516|P3|Participant Flow|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
69789|NCT02141516|P2|Participant Flow|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
69790|NCT02141516|P1|Participant Flow|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
69791|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
69792|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
69793|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
69794|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
69795|NCT02141516|O5|Outcome|Total|Total of subjects
69796|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
69797|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
69798|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
69799|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
69800|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
69801|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
69802|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
69803|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
69804|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
69805|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
69806|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
69807|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
69808|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
69809|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
69810|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
69811|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
69812|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
69813|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
69814|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
69815|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
69816|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
69817|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
69818|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
69819|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
69820|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
69821|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
69822|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
69823|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
69824|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
69825|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
69826|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
69827|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
69828|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
69829|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
69830|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
69831|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
69832|NCT02141516|E5|Reported Event|Total|Total number of Subjects
69833|NCT02141516|E4|Reported Event|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
69834|NCT02141516|E3|Reported Event|CompDef + Asplenia|Subjects aged ≥ 2 to ≤17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
69835|NCT02141516|E2|Reported Event|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
69836|NCT02141516|E1|Reported Event|CompDef|Subjects aged ≥ 2 to ≤17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
69837|NCT02141360|B3|Baseline|Total|Total of all reporting groups
69838|NCT02141360|B2|Baseline|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
69839|NCT02141360|B1|Baseline|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
69840|NCT02141360|P3|Participant Flow|Volunteer Controls|"Non injured volunteers for device calibration~Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
69841|NCT02141360|P2|Participant Flow|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
69842|NCT02141360|P1|Participant Flow|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Traumatic Brain Injury (mTBI)~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
69843|NCT02141360|O3|Outcome|Volunteer Controls|"Non injured volunteers for device calibration~Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
69844|NCT02141360|O2|Outcome|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
69845|NCT02141360|O1|Outcome|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Traumatic Brain Injury (mTBI)~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
69846|NCT02141360|E3|Reported Event|Volunteer Controls|"Non injured volunteers for device calibration~Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
69847|NCT02141360|E2|Reported Event|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
69848|NCT02141360|E1|Reported Event|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Traumatic Brain Injury (mTBI)~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
69849|NCT02141217|B3|Baseline|Total|Total of all reporting groups
69850|NCT02141217|B2|Baseline|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
69851|NCT02141217|B1|Baseline|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
69852|NCT02141217|P2|Participant Flow|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
69853|NCT02141217|P1|Participant Flow|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 milligrams (mg) plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
69854|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
69855|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 milligrams (mg) plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
69856|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
69857|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
69858|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
69859|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
69860|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
69861|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
69862|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants randomized to clindamycin 150 mg.
69863|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants randomized to amoxicillin 875 mg plus clavulanic acid 125 mg.
69864|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
69865|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
69866|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
69867|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
69868|NCT02141217|E2|Reported Event|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
69869|NCT02141217|E1|Reported Event|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 milligrams (mg) plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
69870|NCT02140957|B3|Baseline|Total|Total of all reporting groups
69871|NCT02140957|B2|Baseline|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
69872|NCT02140957|B1|Baseline|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
69873|NCT02140957|P2|Participant Flow|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
69874|NCT02140957|P1|Participant Flow|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
69875|NCT02140957|O2|Outcome|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
69887|NCT02140788|P1|Participant Flow|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.~Metformin"
69888|NCT02140788|O4|Outcome|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
69915|NCT02140645|B4|Baseline|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
69876|NCT02140957|O1|Outcome|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
69877|NCT02140957|O2|Outcome|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
69878|NCT02140957|O1|Outcome|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
69879|NCT02140957|O2|Outcome|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
69880|NCT02140957|O1|Outcome|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
69881|NCT02140957|E2|Reported Event|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
69882|NCT02140957|E1|Reported Event|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
69883|NCT02140788|B1|Baseline|All Subjects Who Consented|All subjects who signed a consent form
69884|NCT02140788|P4|Participant Flow|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
69885|NCT02140788|P3|Participant Flow|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.~Metformin~Fish Oil"
69886|NCT02140788|P2|Participant Flow|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.~Fish Oil"
69889|NCT02140788|O3|Outcome|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.~Metformin~Fish Oil"
70156|NCT02139878|O1|Outcome|Wild Blueberry Juice|240 ml wild blueberry juice
69890|NCT02140788|O2|Outcome|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.~Fish Oil"
69891|NCT02140788|O1|Outcome|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.~Metformin"
69892|NCT02140788|O4|Outcome|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
69893|NCT02140788|O3|Outcome|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.~Metformin~Fish Oil"
69894|NCT02140788|O2|Outcome|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.~Fish Oil"
69895|NCT02140788|O1|Outcome|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.~Metformin"
69896|NCT02140788|O4|Outcome|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
69897|NCT02140788|O3|Outcome|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.~Metformin~Fish Oil"
69898|NCT02140788|O2|Outcome|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.~Fish Oil"
69899|NCT02140788|O1|Outcome|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.~Metformin"
69900|NCT02140788|O4|Outcome|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
69901|NCT02140788|O3|Outcome|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.~Metformin~Fish Oil"
69902|NCT02140788|O2|Outcome|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.~Fish Oil"
69903|NCT02140788|O1|Outcome|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.~Metformin"
69904|NCT02140788|O4|Outcome|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
69905|NCT02140788|O3|Outcome|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.~Metformin~Fish Oil"
69906|NCT02140788|O2|Outcome|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.~Fish Oil"
69907|NCT02140788|O1|Outcome|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.~Metformin"
69908|NCT02140788|E4|Reported Event|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
69909|NCT02140788|E3|Reported Event|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.~Metformin~Fish Oil"
69910|NCT02140788|E2|Reported Event|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.~Fish Oil"
69911|NCT02140788|E1|Reported Event|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.~Metformin"
69912|NCT02140645|B7|Baseline|Total|Total of all reporting groups
69913|NCT02140645|B6|Baseline|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
69914|NCT02140645|B5|Baseline|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
71245|NCT02135016|B2|Baseline|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
69916|NCT02140645|B3|Baseline|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
69917|NCT02140645|B2|Baseline|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69918|NCT02140645|B1|Baseline|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69919|NCT02140645|P6|Participant Flow|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
69920|NCT02140645|P5|Participant Flow|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
69921|NCT02140645|P4|Participant Flow|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
69922|NCT02140645|P3|Participant Flow|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
69923|NCT02140645|P2|Participant Flow|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69924|NCT02140645|P1|Participant Flow|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69925|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
69926|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
69927|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
69928|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
69929|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69930|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69931|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
69932|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
69933|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
69934|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
69935|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69936|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69937|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
69938|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
69939|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
69940|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
69941|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69942|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69943|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
69944|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
69945|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
70066|NCT02140060|E7|Reported Event|Pre-treatment|All subjects who signed an informed consent to participate in the study
69946|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
69947|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69948|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69949|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
69950|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
69951|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
69952|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
69953|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69954|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69955|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
69956|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
69957|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
69958|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
69959|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69960|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69961|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
69962|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
69963|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
69964|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
69965|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69966|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69967|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
69968|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
69969|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
69970|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
69971|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69972|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69973|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
69974|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
69975|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
70109|NCT02139982|O1|Outcome|Group A(Phase 2)|"30ml ropivacaine 0.125%~ropivacaine: Different concentration of ropivacaine"
69976|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
69977|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69978|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69979|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
69980|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
69981|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
69982|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
69983|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69984|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69985|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
69986|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
69987|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
69988|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
69989|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69990|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69991|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
69992|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
69993|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
69994|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
69995|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69996|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
69997|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
69998|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
69999|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
70000|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
70001|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
70002|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
70003|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
70004|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
70005|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
70153|NCT02139878|O2|Outcome|Placebo|240 ml placebo beverage
70154|NCT02139878|O1|Outcome|Wild Blueberry Juice|240 ml wild blueberry juice
70006|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
70007|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
70008|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
70009|NCT02140645|E1|Reported Event|MarketScan|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication identified from the MarketScan database.
70010|NCT02140593|B3|Baseline|Total|Total of all reporting groups
70011|NCT02140593|B2|Baseline|Deep Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.~Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment."
70012|NCT02140593|B1|Baseline|Standard Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo).~Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo)."
70013|NCT02140593|P2|Participant Flow|Deep Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.~Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment."
70014|NCT02140593|P1|Participant Flow|Standard Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo).~Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo)."
70015|NCT02140593|O2|Outcome|Deep Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.~Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment."
70016|NCT02140593|O1|Outcome|Standard Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo).~Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo)."
70017|NCT02140593|O2|Outcome|Deep Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.~Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment."
70018|NCT02140593|O1|Outcome|Standard Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo).~Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo)."
70019|NCT02140593|E2|Reported Event|Deep Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.~Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment."
70020|NCT02140593|E1|Reported Event|Standard Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo).~Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo)."
70021|NCT02140372|B1|Baseline|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
70022|NCT02140372|P1|Participant Flow|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
70023|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
70024|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
70025|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
70026|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
70027|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
70028|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
70029|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
70030|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
70031|NCT02140372|E1|Reported Event|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
70032|NCT02140164|B1|Baseline|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
70033|NCT02140164|P1|Participant Flow|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
70034|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
70035|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
70036|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
70037|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
70038|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
70039|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
70040|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
70041|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
70042|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
70043|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
70044|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
70045|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
70046|NCT02140164|E1|Reported Event|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
70047|NCT02140060|B7|Baseline|Total|Total of all reporting groups
70048|NCT02140060|B6|Baseline|TRAV Z + AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
70049|NCT02140060|B5|Baseline|AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks
70050|NCT02140060|B4|Baseline|TRAV Z|Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
70051|NCT02140060|B3|Baseline|TravC/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
70052|NCT02140060|B2|Baseline|TravB/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
70053|NCT02140060|B1|Baseline|TravA/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
70054|NCT02140060|P6|Participant Flow|TRAV Z + AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
70055|NCT02140060|P5|Participant Flow|AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks
70056|NCT02140060|P4|Participant Flow|TRAV Z|Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
70057|NCT02140060|P3|Participant Flow|TravC/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
70058|NCT02140060|P2|Participant Flow|TravB/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
70059|NCT02140060|P1|Participant Flow|TravA/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
70060|NCT02140060|O6|Outcome|TRAV Z + AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
70061|NCT02140060|O5|Outcome|AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks
70062|NCT02140060|O4|Outcome|TRAV Z|Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
70063|NCT02140060|O3|Outcome|TravC/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
70064|NCT02140060|O2|Outcome|TravB/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
70065|NCT02140060|O1|Outcome|TravA/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
70067|NCT02140060|E6|Reported Event|TRAV Z + AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
70068|NCT02140060|E5|Reported Event|AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks
70069|NCT02140060|E4|Reported Event|TRAV Z|Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
70070|NCT02140060|E3|Reported Event|TravC/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
70071|NCT02140060|E2|Reported Event|TravB/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
70072|NCT02140060|E1|Reported Event|TravA/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
70073|NCT02139982|B11|Baseline|Total|Total of all reporting groups
70074|NCT02139982|B10|Baseline|Group F(Phase 2)|"30ml ropivacaine 0.75%~ropivacaine: Different concentration of ropivacaine"
70075|NCT02139982|B9|Baseline|Group E(Phase 2)|"30ml ropivacaine 0.5%~ropivacaine: Different concentration of ropivacaine"
70076|NCT02139982|B8|Baseline|Group D(Phase 2)|"30ml ropivacaine 0.375%~ropivacaine: Different concentration of ropivacaine"
70077|NCT02139982|B7|Baseline|Group C(Phase 2)|"30ml ropivacaine 0.25%~ropivacaine: Different concentration of ropivacaine"
70078|NCT02139982|B6|Baseline|Group B(Phase 2)|"30ml ropivacaine 0.2%~ropivacaine: Different concentration of ropivacaine"
70079|NCT02139982|B5|Baseline|Group A(Phase 2)|"30ml ropivacaine 0.125%~ropivacaine: Different concentration of ropivacaine"
70080|NCT02139982|B4|Baseline|Group ME (Phase 1)|"specific nerve block:median nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
70081|NCT02139982|B3|Baseline|Group RA (Phase 1)|"specific nerve block:radial nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
70082|NCT02139982|B2|Baseline|Group UL( Phase 1)|"specific nerve block:ulnar nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
70083|NCT02139982|B1|Baseline|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
70084|NCT02139982|P10|Participant Flow|Group F(Phase 2)|"30ml ropivacaine 0.75%~ropivacaine: Different concentration of ropivacaine"
70085|NCT02139982|P9|Participant Flow|Group E(Phase 2)|"30ml ropivacaine 0.5%~ropivacaine: Different concentration of ropivacaine"
70086|NCT02139982|P8|Participant Flow|Group D(Phase 2)|"30ml ropivacaine 0.375%~ropivacaine: Different concentration of ropivacaine"
70087|NCT02139982|P7|Participant Flow|Group C(Phase 2)|"30ml ropivacaine 0.25%~ropivacaine: Different concentration of ropivacaine"
70088|NCT02139982|P6|Participant Flow|Group B(Phase 2)|"30ml ropivacaine 0.2%~ropivacaine: Different concentration of ropivacaine"
70089|NCT02139982|P5|Participant Flow|Group A(Phase 2)|"30ml ropivacaine 0.125%~ropivacaine: Different concentration of ropivacaine"
70090|NCT02139982|P4|Participant Flow|Group ME (Phase 1)|"specific nerve block:median nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
70091|NCT02139982|P3|Participant Flow|Group RA (Phase 1)|"specific nerve block:radial nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
70092|NCT02139982|P2|Participant Flow|Group UL( Phase 1)|"specific nerve block:ulnar nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
70093|NCT02139982|P1|Participant Flow|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
70094|NCT02139982|O4|Outcome|Group ME (Phase 1)|"specific nerve block:median nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
70095|NCT02139982|O3|Outcome|Group RA (Phase 1)|"specific nerve block:radial nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
70096|NCT02139982|O2|Outcome|Group UL( Phase 1)|"specific nerve block:ulnar nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
70097|NCT02139982|O1|Outcome|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
70098|NCT02139982|O6|Outcome|Group F(Phase 2)|"30ml ropivacaine 0.75%~ropivacaine: Different concentration of ropivacaine"
70099|NCT02139982|O5|Outcome|Group E(Phase 2)|"30ml ropivacaine 0.5%~ropivacaine: Different concentration of ropivacaine"
70100|NCT02139982|O4|Outcome|Group D(Phase 2)|"30ml ropivacaine 0.375%~ropivacaine: Different concentration of ropivacaine"
70101|NCT02139982|O3|Outcome|Group C(Phase 2)|"30ml ropivacaine 0.25%~ropivacaine: Different concentration of ropivacaine"
70102|NCT02139982|O2|Outcome|Group B(Phase 2)|"30ml ropivacaine 0.2%~ropivacaine: Different concentration of ropivacaine"
70103|NCT02139982|O1|Outcome|Group A(Phase 2)|"30ml ropivacaine 0.125%~ropivacaine: Different concentration of ropivacaine"
70104|NCT02139982|O6|Outcome|Group F(Phase 2)|"30ml ropivacaine 0.75%~ropivacaine: Different concentration of ropivacaine"
70105|NCT02139982|O5|Outcome|Group E(Phase 2)|"30ml ropivacaine 0.5%~ropivacaine: Different concentration of ropivacaine"
70106|NCT02139982|O4|Outcome|Group D(Phase 2)|"30ml ropivacaine 0.375%~ropivacaine: Different concentration of ropivacaine"
70107|NCT02139982|O3|Outcome|Group C(Phase 2)|"30ml ropivacaine 0.25%~ropivacaine: Different concentration of ropivacaine"
70108|NCT02139982|O2|Outcome|Group B(Phase 2)|"30ml ropivacaine 0.2%~ropivacaine: Different concentration of ropivacaine"
70110|NCT02139982|O4|Outcome|Group ME (Phase 1)|"specific nerve block:median nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
70111|NCT02139982|O3|Outcome|Group RA (Phase 1)|"specific nerve block:radial nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
70112|NCT02139982|O2|Outcome|Group UL( Phase 1)|"specific nerve block:ulnar nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
70113|NCT02139982|O1|Outcome|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
70114|NCT02139982|O6|Outcome|Group F(Phase 2)|"30ml ropivacaine 0.75%~ropivacaine: Different concentration of ropivacaine"
70115|NCT02139982|O5|Outcome|Group E(Phase 2)|"30ml ropivacaine 0.5%~ropivacaine: Different concentration of ropivacaine"
70116|NCT02139982|O4|Outcome|Group D(Phase 2)|"30ml ropivacaine 0.375%~ropivacaine: Different concentration of ropivacaine"
70117|NCT02139982|O3|Outcome|Group C(Phase 2)|"30ml ropivacaine 0.25%~ropivacaine: Different concentration of ropivacaine"
70118|NCT02139982|O2|Outcome|Group B(Phase 2)|"30ml ropivacaine 0.2%~ropivacaine: Different concentration of ropivacaine"
70119|NCT02139982|O1|Outcome|Group A(Phase 2)|"30ml ropivacaine 0.125%~ropivacaine: Different concentration of ropivacaine"
70120|NCT02139982|O4|Outcome|Group ME (Phase 1)|"specific nerve block:median nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
70121|NCT02139982|O3|Outcome|Group RA (Phase 1)|"specific nerve block:radial nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
70122|NCT02139982|O2|Outcome|Group UL( Phase 1)|"specific nerve block:ulnar nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
70123|NCT02139982|O1|Outcome|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
70124|NCT02139982|E10|Reported Event|Group F(Phase 2)|"30ml ropivacaine 0.75%~ropivacaine: Different concentration of ropivacaine"
70125|NCT02139982|E9|Reported Event|Group E(Phase 2)|"30ml ropivacaine 0.5%~ropivacaine: Different concentration of ropivacaine"
70126|NCT02139982|E8|Reported Event|Group D(Phase 2)|"30ml ropivacaine 0.375%~ropivacaine: Different concentration of ropivacaine"
70127|NCT02139982|E7|Reported Event|Group C(Phase 2)|"30ml ropivacaine 0.25%~ropivacaine: Different concentration of ropivacaine"
70128|NCT02139982|E6|Reported Event|Group B(Phase 2)|"30ml ropivacaine 0.2%~ropivacaine: Different concentration of ropivacaine"
70129|NCT02139982|E5|Reported Event|Group A(Phase 2)|"30ml ropivacaine 0.125%~ropivacaine: Different concentration of ropivacaine"
70130|NCT02139982|E4|Reported Event|Group ME (Phase 1)|"specific nerve block:median nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
70131|NCT02139982|E3|Reported Event|Group RA (Phase 1)|"specific nerve block:radial nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
70132|NCT02139982|E2|Reported Event|Group UL( Phase 1)|"specific nerve block:ulnar nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
70133|NCT02139982|E1|Reported Event|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
70134|NCT02139943|B4|Baseline|Total|Total of all reporting groups
70135|NCT02139943|B3|Baseline|Canagliflozin 300 mg|Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
70136|NCT02139943|B2|Baseline|Canagliflozin 100 Milligram (mg)|Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
70137|NCT02139943|B1|Baseline|Placebo|Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
70138|NCT02139943|P3|Participant Flow|Canagliflozin 300 mg|Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
70139|NCT02139943|P2|Participant Flow|Canagliflozin 100 Milligram (mg)|Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
70140|NCT02139943|P1|Participant Flow|Placebo|Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
70141|NCT02139943|O3|Outcome|Canagliflozin 300 mg|Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
70142|NCT02139943|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
70143|NCT02139943|O1|Outcome|Placebo|Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
70144|NCT02139943|O3|Outcome|Canagliflozin 300 mg|Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
70145|NCT02139943|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
70146|NCT02139943|O1|Outcome|Placebo|Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
70147|NCT02139943|E3|Reported Event|Canagliflozin 300 mg|Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
70148|NCT02139943|E2|Reported Event|Canagliflozin 100 Milligram (mg)|Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
70149|NCT02139943|E1|Reported Event|Placebo|Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
70150|NCT02139878|B1|Baseline|Entire Study Population|Includes groups randomized to receive Wild Blueberry Juice first and Placebo first
70151|NCT02139878|P2|Participant Flow|Placebo First, Then Wild Blueberry Juice|240 ml Placebo beverage daily in first intervention period and 240 ml Wild Blueberry Juice daily in second intervention period (after washout period).
70152|NCT02139878|P1|Participant Flow|Wild Blueberry Juice First, Then Placebo|240 ml Wild Blueberry Juice daily first in intervention period and 240 ml Placebo beverage daily in second intervention period (after washout period)
70157|NCT02139878|E2|Reported Event|Placebo|240 ml Placebo beverage daily in either the first intervention period or second intervention period
70158|NCT02139878|E1|Reported Event|Wild Blueberry Juice|240 ml Wild Blueberry Juice daily in either first intervention period or second intervention period
70159|NCT02139644|B6|Baseline|Total|Total of all reporting groups
70160|NCT02139644|B5|Baseline|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70161|NCT02139644|B4|Baseline|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70162|NCT02139644|B3|Baseline|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70163|NCT02139644|B2|Baseline|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70164|NCT02139644|B1|Baseline|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70165|NCT02139644|P6|Participant Flow|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70166|NCT02139644|P5|Participant Flow|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70167|NCT02139644|P4|Participant Flow|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70168|NCT02139644|P3|Participant Flow|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70169|NCT02139644|P2|Participant Flow|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70170|NCT02139644|P1|Participant Flow|Enrolled Patients|During the run-in period (from the screening visit to the randomization visit), all patients replaced their current rescue medication with study-specific rescue medication (albuterol/salbutamol HFA MDI) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the period. All patients discontinued their current ICS or ICS/LABA, and took 1 inhalation twice a day from a single-blinded placebo MDPI device and 1 puff twice a day from open-label QVAR 40 mcg HFA MDI (or equivalent).
70171|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70172|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70173|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70174|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70175|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70259|NCT02139137|O1|Outcome|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task~Computerized Cognitive Training - active: Cognitive training using working memory span task"
70176|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70177|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70178|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70179|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70180|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70181|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70182|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70183|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70184|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70185|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70186|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70187|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70188|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70189|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70190|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70191|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70192|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70193|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70364|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
70194|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70195|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70196|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70197|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70198|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70199|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70200|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70201|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70202|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70203|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70204|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70205|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70206|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70207|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70208|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70209|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70210|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70211|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70212|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70213|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70214|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70215|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70216|NCT02139644|E5|Reported Event|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70217|NCT02139644|E4|Reported Event|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70218|NCT02139644|E3|Reported Event|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70219|NCT02139644|E2|Reported Event|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70220|NCT02139644|E1|Reported Event|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
70221|NCT02139228|B3|Baseline|Total|Total of all reporting groups
70222|NCT02139228|B2|Baseline|Hib TT|"Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
70223|NCT02139228|B1|Baseline|Hib CRM197|"Subjects treated with 3 doses of CRM 197 –conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
70224|NCT02139228|P2|Participant Flow|Hib TT|"Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
70225|NCT02139228|P1|Participant Flow|Hib CRM197|"Subjects treated with 3 doses of CRM 197 –conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
70226|NCT02139228|O2|Outcome|Hib TT|"Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
70227|NCT02139228|O1|Outcome|Hib CRM197|"Subjects treated with 3 doses of CRM 197 –conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
70228|NCT02139228|O2|Outcome|Hib TT|"Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
70229|NCT02139228|O1|Outcome|Hib CRM197|"Subjects treated with 3 doses of CRM 197 –conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
70230|NCT02139228|E2|Reported Event|Hib TT|"Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
70231|NCT02139228|E1|Reported Event|Hib CRM197|"Subjects treated with 3 doses of CRM 197 –conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
70232|NCT02139176|B3|Baseline|Total|Total of all reporting groups
70233|NCT02139176|B2|Baseline|Contract Referral|"Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.~contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.~patient referral: A patient agrees to recruit their partner using the invitation."
70234|NCT02139176|B1|Baseline|Patient Referral|"Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information~patient referral: A patient agrees to recruit their partner using the invitation."
70235|NCT02139176|P2|Participant Flow|Contract Referral|"Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.~contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.~patient referral: A patient agrees to recruit their partner using the invitation."
70236|NCT02139176|P1|Participant Flow|Patient Referral|"Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information~patient referral: A patient agrees to recruit their partner using the invitation."
70237|NCT02139176|O2|Outcome|Contract Referral|"Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.~contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community."
70238|NCT02139176|O1|Outcome|Patient Referral|"Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information~patient referral: A patient agrees to recruit their partner using the invitation."
70239|NCT02139176|O2|Outcome|Contract Referral|"Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.~Contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community."
70240|NCT02139176|O1|Outcome|Patient Referral|"Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information~patient referral: A patient agrees to recruit their partner using the invitation."
70241|NCT02139176|O2|Outcome|Contract Referral|"Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.~contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community."
70242|NCT02139176|O1|Outcome|Patient Referral|"Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information~patient referral: A patient agrees to recruit their partner using the invitation."
70243|NCT02139176|E2|Reported Event|Contract Referral|"Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.~contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community."
70244|NCT02139176|E1|Reported Event|Patient Referral|"Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information~patient referral: A patient agrees to recruit their partner using the invitation."
70245|NCT02139137|B3|Baseline|Total|Total of all reporting groups
70246|NCT02139137|B2|Baseline|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task~Computerized cognitive training - sham: Sham training condition"
70247|NCT02139137|B1|Baseline|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task~Computerized Cognitive Training - active: Cognitive training using working memory span task"
70248|NCT02139137|P2|Participant Flow|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task~Computerized cognitive training - sham: Sham training condition"
70249|NCT02139137|P1|Participant Flow|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task~Computerized Cognitive Training - active: Cognitive training using working memory span task"
70250|NCT02139137|O2|Outcome|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task~Computerized cognitive training - sham: Sham training condition"
70251|NCT02139137|O1|Outcome|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task~Computerized Cognitive Training - active: Cognitive training using working memory span task"
70252|NCT02139137|O2|Outcome|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task~Computerized cognitive training - sham: Sham training condition"
70253|NCT02139137|O1|Outcome|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task~Computerized Cognitive Training - active: Cognitive training using working memory span task"
70254|NCT02139137|O2|Outcome|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task~Computerized cognitive training - sham: Sham training condition"
70255|NCT02139137|O1|Outcome|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task~Computerized Cognitive Training - active: Cognitive training using working memory span task"
70256|NCT02139137|O2|Outcome|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task~Computerized cognitive training - sham: Sham training condition"
70257|NCT02139137|O1|Outcome|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task~Computerized Cognitive Training - active: Cognitive training using working memory span task"
70258|NCT02139137|O2|Outcome|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task~Computerized cognitive training - sham: Sham training condition"
71246|NCT02135016|B1|Baseline|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
70260|NCT02139137|E2|Reported Event|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task~Computerized cognitive training - sham: Sham training condition"
70261|NCT02139137|E1|Reported Event|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task~Computerized Cognitive Training - active: Cognitive training using working memory span task"
70262|NCT02139046|B6|Baseline|Total|Total of all reporting groups
70263|NCT02139046|B5|Baseline|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70264|NCT02139046|B4|Baseline|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70265|NCT02139046|B3|Baseline|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70266|NCT02139046|B2|Baseline|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70267|NCT02139046|B1|Baseline|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70268|NCT02139046|P5|Participant Flow|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70269|NCT02139046|P4|Participant Flow|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70270|NCT02139046|P3|Participant Flow|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70271|NCT02139046|P2|Participant Flow|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70272|NCT02139046|P1|Participant Flow|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70273|NCT02139046|O5|Outcome|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70274|NCT02139046|O4|Outcome|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70275|NCT02139046|O3|Outcome|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70276|NCT02139046|O2|Outcome|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70277|NCT02139046|O1|Outcome|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70278|NCT02139046|O5|Outcome|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70466|NCT02138097|B11|Baseline|MS: Sitagliptin|Patients in the MarketScan (MS) cohort using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
70279|NCT02139046|O4|Outcome|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70280|NCT02139046|O3|Outcome|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70281|NCT02139046|O2|Outcome|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70282|NCT02139046|O1|Outcome|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70283|NCT02139046|O5|Outcome|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70284|NCT02139046|O4|Outcome|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70285|NCT02139046|O3|Outcome|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70286|NCT02139046|O2|Outcome|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70287|NCT02139046|O1|Outcome|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70288|NCT02139046|E5|Reported Event|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70289|NCT02139046|E4|Reported Event|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70290|NCT02139046|E3|Reported Event|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70291|NCT02139046|E2|Reported Event|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70292|NCT02139046|E1|Reported Event|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
70293|NCT02139007|B3|Baseline|Total|Total of all reporting groups
70294|NCT02139007|B2|Baseline|Discontinuation Arm|Alendronate discontinuation arm
70295|NCT02139007|B1|Baseline|Continuation Arm|Alendronate continuation arm
70296|NCT02139007|P2|Participant Flow|Discontinuation Arm|"Alendronate discontinuation arm~Participants were randomized to stop taking their current alendronate prescription."
70297|NCT02139007|P1|Participant Flow|Continuation Arm|"Alendronate continuation arm~Participants were randomized to continue their current alendronate prescription at prescribed dose."
70298|NCT02139007|O2|Outcome|Discontinuation Arm|"Alendronate discontinuation arm~Alendronate"
70299|NCT02139007|O1|Outcome|Continuation Arm|"Alendronate continuation arm~Alendronate"
70300|NCT02139007|O2|Outcome|Discontinuation Arm|"Alendronate discontinuation arm~Alendronate"
70301|NCT02139007|O1|Outcome|Continuation Arm|"Alendronate continuation arm~Alendronate"
70302|NCT02139007|O2|Outcome|Discontinuation Arm|"Alendronate discontinuation arm~Alendronate"
70303|NCT02139007|O1|Outcome|Continuation Arm|"Alendronate continuation arm~Alendronate"
70304|NCT02139007|O1|Outcome|All Study Sites-Initiation to the First Participant Recruited|study initiation to the first participant recruited
70467|NCT02138097|B10|Baseline|MS: Linagliptin|Patients in the MarketScan (MS) cohort using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
70305|NCT02139007|O1|Outcome|All Study Sites --IRB Approval|The duration of time from execution of contracts, IRB approval, and to participant recruitment is potential contributor to overall suboptimal recruitment in clinical research. In this pilot study we measured the mean duration of administrative procedures for sites to the first patient enrolled. .
70306|NCT02139007|O1|Outcome|All Study Sites -- Contracting Procedures|The duration of time from execution of contracts, IRB approval, and to participant recruitment is potential contributor to overall suboptimal recruitment in clinical research. In this pilot study we measured the mean duration of administrative procedures for sites to the first patient enrolled. .
70307|NCT02139007|E2|Reported Event|Discontinuation Arm|"Alendronate discontinuation arm~Alendronate"
70308|NCT02139007|E1|Reported Event|Continuation Arm|"Alendronate continuation arm~Alendronate"
70309|NCT02138838|B3|Baseline|Total|Total of all reporting groups
70310|NCT02138838|B2|Baseline|Cinacalcet|In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
70311|NCT02138838|B1|Baseline|Standard of Care|Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
70312|NCT02138838|P2|Participant Flow|Cinacalcet|In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
70313|NCT02138838|P1|Participant Flow|Standard of Care|Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
70314|NCT02138838|O2|Outcome|Cinacalcet|In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
70315|NCT02138838|O1|Outcome|Standard of Care|Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
70316|NCT02138838|O2|Outcome|Cinacalcet|In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
70317|NCT02138838|O1|Outcome|Standard of Care|Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
70318|NCT02138838|O2|Outcome|Cinacalcet|In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
70319|NCT02138838|O1|Outcome|Standard of Care|Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
70320|NCT02138838|O2|Outcome|Cinacalcet|In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
70321|NCT02138838|O1|Outcome|Standard of Care|Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
70322|NCT02138838|O2|Outcome|Cinacalcet|In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
70323|NCT02138838|O1|Outcome|Standard of Care|Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
70324|NCT02138838|O2|Outcome|Cinacalcet|In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
70325|NCT02138838|O1|Outcome|Standard of Care|Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
70326|NCT02138838|E2|Reported Event|Cinacalcet|In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
70327|NCT02138838|E1|Reported Event|Standard of Care|Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
70328|NCT02138825|B3|Baseline|Total|Total of all reporting groups
70329|NCT02138825|B2|Baseline|Placebo|In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
70330|NCT02138825|B1|Baseline|Riociguat (Adempas, BAY63-2521)|In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
70365|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
70514|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
70331|NCT02138825|P2|Participant Flow|Placebo|In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
70332|NCT02138825|P1|Participant Flow|Riociguat (Adempas, BAY63-2521)|In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
70333|NCT02138825|O2|Outcome|Placebo|All participants that were initially randomized to placebo were taken off study drug at the time of study termination, and started the 120 days safety follow-up phase, regardless of whether they were in the main phase or in the LTE. Participants who had the End of Treatment visit prior to the implementation of the 120-day safety follow-up were followed-up for at least 30 days.
70334|NCT02138825|O1|Outcome|Riociguat up to 2.5 mg Tid|All participants that were initially randomized to Rioiciguat treatment were taken off study drug at the time of study termination, and started the 120 days safety follow-up phase, regardless of whether they were in the main phase or in the LTE. Participants who had the End of Treatment visit prior to the implementation of the 120-day safety follow-up were followed-up for at least 30 days.
70335|NCT02138825|O1|Outcome|Placebo|In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
70336|NCT02138825|O1|Outcome|Riociguat (Adempas, BAY63-2521)|In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
70337|NCT02138825|O2|Outcome|Placebo|In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
70338|NCT02138825|O1|Outcome|Riociguat (Adempas, BAY63-2521)|In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
70339|NCT02138825|O2|Outcome|Placebo|In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
70340|NCT02138825|O1|Outcome|Riociguat (Adempas, BAY63-2521)|In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
70341|NCT02138825|E4|Reported Event|Placebo-Riociguat Transition|Reporting group 4 (RG 4): All participants that were initially randomized to Placebo treatment in Main study treatment phase and later entered LTE phase (data starting from week 26 to study termination); participants received a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until the study was terminated. Note: safety data presented here include participants in Placebo Arm of Period 2 in Participant Flow section.
70366|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
70468|NCT02138097|B9|Baseline|UHC: GLP-I RA|Patients in the United Healthcare cohort using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
70342|NCT02138825|E3|Reported Event|Riociguat-Riociguat Transition|Reporting group 3 (RG 3): All participants that were initially randomized to Riociguat treatment in Main study treatment phase and later entered Long-term extension (LTE) phase (data starting from week 26 to study termination); participants received a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until the study was terminated. Note: safety data presented here include participants in Riociguat Arm of Period 2 in Participant Flow section.
70343|NCT02138825|E2|Reported Event|Placebo|Reporting group 2 (RG 2): All participants randomized to Placebo treatment in Main study treatment phase (data until week 26); participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. Note: safety data presented here include participants in Placebo Arm of Period 1 in Participant Flow section.
70344|NCT02138825|E1|Reported Event|Riociguat up to 2.5 mg Tid|Reporting group 1 (RG 1): All participants randomized to Riociguat treatment in Main study treatment phase (data until week 26); participants received Riociguat titrated to optimal dose within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. Note: safety data presented here include participants in Riociguat Arm of Period 1 in Participant Flow section.
70345|NCT02138747|B5|Baseline|Total|Total of all reporting groups
70346|NCT02138747|B4|Baseline|BB: Tolterodine ER /Tolterodine ER|Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
70347|NCT02138747|B3|Baseline|AA: Mirabegron/Mirabegron|In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
70348|NCT02138747|B2|Baseline|BA: Tolterodine ER /Mirabegron|In the treatment sequence BA participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron (OCAS) modified-release tablets orally once a day during period 1. In the period 2, participants received 25 mg of mirabegron and 4 mg of PTM tolterodine ER orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
70349|NCT02138747|B1|Baseline|AB: Mirabegron/Tolterodine ER|In the treatment sequence AB participants received 25 mg of mirabegron (Myrbetriq) oral controlled absorption system (OCAS) modified-release tablets and 4 mg of placebo-to-match (PTM) tolterodine ER (Detrol LA) orally once a day during period 1. In the period 2, participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
70350|NCT02138747|P4|Participant Flow|BB: Tolterodine ER /Tolterodine ER|Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
70351|NCT02138747|P3|Participant Flow|AA: Mirabegron/Mirabegron|In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
70352|NCT02138747|P2|Participant Flow|BA: Tolterodine ER /Mirabegron|In the treatment sequence BA participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron (OCAS) modified-release tablets orally once a day during period 1. In the period 2, participants received 25 mg of mirabegron and 4 mg of PTM tolterodine ER orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
70353|NCT02138747|P1|Participant Flow|AB: Mirabegron/Tolterodine ER|In the treatment sequence AB participants received 25 mg of mirabegron (Myrbetriq) oral controlled absorption system (OCAS) modified-release tablets and 4 mg of placebo-to-match (PTM) tolterodine ER (Detrol LA) orally once a day during period 1. In the period 2, participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
70354|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
70355|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
70356|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
70357|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
70358|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
70359|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
70360|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
70361|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
70362|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
70363|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
70367|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
70368|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
70369|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
70370|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
70371|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
70372|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
70373|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
70374|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
70375|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
70376|NCT02138747|O4|Outcome|BB: Tolterodine ER /Tolterodine ER|Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
70377|NCT02138747|O3|Outcome|AA: Mirabegron/Mirabegron|In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
70378|NCT02138747|O2|Outcome|BA: Tolterodine ER /Mirabegron|In the treatment sequence BA participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron (OCAS) modified-release tablets orally once a day during period 1. In the period 2, participants received 25 mg of mirabegron and 4 mg of PTM tolterodine ER orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
70379|NCT02138747|O1|Outcome|AB: Mirabegron/Tolterodine ER|In the treatment sequence AB participants received 25 mg of mirabegron (Myrbetriq) oral controlled absorption system (OCAS) modified-release tablets and 4 mg of placebo-to-match (PTM) tolterodine ER (Detrol LA) orally once a day during period 1. In the period 2, participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
70380|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
70381|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
70382|NCT02138747|E2|Reported Event|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
70383|NCT02138747|E1|Reported Event|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
70384|NCT02138578|B4|Baseline|Total|Total of all reporting groups
70385|NCT02138578|B3|Baseline|Non-Randomized SBRT|"Patients with renal cell carcinoma's greater than or equal to 4 cm in diameter, and up to 8 cm in diameter, may be placed in the non-randomized stereotactic body radiation therapy arm. Patients with tumors not amenable to RFA, those with metastatic disease, and those who elect a noninvasive means of treatment will also be eligible to receive treatment in the non-randomized SBRT cohort.~SBRT"
70386|NCT02138578|B2|Baseline|Randomized RFA|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Radiofrequency Ablation (RFA) will receive RFA.~RFA"
70387|NCT02138578|B1|Baseline|Randomized SBRT|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Stereotactic Body Radiation Therapy (SBRT) will receive SBRT delivered in fractions of 20 Gy, approximately every other day, for a total of three treatments. If the target is deemed too close to organs at risk, 5 fractions of up to 10 Gy per fraction will be prescribed.~SBRT"
70388|NCT02138578|P3|Participant Flow|Non-Randomized SBRT|"Patients with renal cell carcinoma's greater than or equal to 4 cm in diameter, and up to 8 cm in diameter, may be placed in the non-randomized stereotactic body radiation therapy arm. Patients with tumors not amenable to RFA, those with metastatic disease, and those who elect a noninvasive means of treatment will also be eligible to receive treatment in the non-randomized SBRT cohort.~SBRT"
70389|NCT02138578|P2|Participant Flow|Randomized RFA|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Radiofrequency Ablation (RFA) will receive RFA.~RFA"
70439|NCT02138227|O8|Outcome|Senior Post-Intervention Relational Communication (Autonomous)|Mean of items measuring emotion, tone, and levels of sincerity, honesty, willingness to listen, and cooperation of senior requesters in the autonomous post-intervention arm. Senior participants are defined has having more than 36 months of experience.
70390|NCT02138578|P1|Participant Flow|Randomized SBRT|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Stereotactic Body Radiation Therapy (SBRT) will receive SBRT delivered in fractions of 20 Gy, approximately every other day, for a total of three treatments. If the target is deemed too close to organs at risk, 5 fractions of up to 10 Gy per fraction will be prescribed.~SBRT"
70391|NCT02138578|O3|Outcome|Non-Randomized SBRT|"Patients with renal cell carcinoma's greater than or equal to 4 cm in diameter, and up to 8 cm in diameter, may be placed in the non-randomized stereotactic body radiation therapy arm. Patients with tumors not amenable to RFA, those with metastatic disease, and those who elect a noninvasive means of treatment will also be eligible to receive treatment in the non-randomized SBRT cohort.~SBRT"
70392|NCT02138578|O2|Outcome|Randomized RFA|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Radiofrequency Ablation (RFA) will receive RFA.~RFA"
70393|NCT02138578|O1|Outcome|Randomized SBRT|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Stereotactic Body Radiation Therapy (SBRT) will receive SBRT delivered in fractions of 20 Gy, approximately every other day, for a total of three treatments. If the target is deemed too close to organs at risk, 5 fractions of up to 10 Gy per fraction will be prescribed.~SBRT"
70394|NCT02138578|O3|Outcome|Non-Randomized SBRT|"Patients with renal cell carcinoma's greater than or equal to 4 cm in diameter, and up to 8 cm in diameter, may be placed in the non-randomized stereotactic body radiation therapy arm. Patients with tumors not amenable to RFA, those with metastatic disease, and those who elect a noninvasive means of treatment will also be eligible to receive treatment in the non-randomized SBRT cohort.~SBRT"
70395|NCT02138578|O2|Outcome|Randomized RFA|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Radiofrequency Ablation (RFA) will receive RFA.~RFA"
70396|NCT02138578|O1|Outcome|Randomized SBRT|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Stereotactic Body Radiation Therapy (SBRT) will receive SBRT delivered in fractions of 20 Gy, approximately every other day, for a total of three treatments. If the target is deemed too close to organs at risk, 5 fractions of up to 10 Gy per fraction will be prescribed.~SBRT"
70397|NCT02138578|O3|Outcome|Non-Randomized SBRT|"Patients with renal cell carcinoma's greater than or equal to 4 cm in diameter, and up to 8 cm in diameter, may be placed in the non-randomized stereotactic body radiation therapy arm. Patients with tumors not amenable to RFA, those with metastatic disease, and those who elect a noninvasive means of treatment will also be eligible to receive treatment in the non-randomized SBRT cohort.~SBRT"
70398|NCT02138578|O2|Outcome|Randomized RFA|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Radiofrequency Ablation (RFA) will receive RFA.~RFA"
70399|NCT02138578|O1|Outcome|Randomized SBRT|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Stereotactic Body Radiation Therapy (SBRT) will receive SBRT delivered in fractions of 20 Gy, approximately every other day, for a total of three treatments. If the target is deemed too close to organs at risk, 5 fractions of up to 10 Gy per fraction will be prescribed.~SBRT"
70400|NCT02138578|O3|Outcome|Non-Randomized SBRT|"Patients with renal cell carcinoma's greater than or equal to 4 cm in diameter, and up to 8 cm in diameter, may be placed in the non-randomized stereotactic body radiation therapy arm. Patients with tumors not amenable to RFA, those with metastatic disease, and those who elect a noninvasive means of treatment will also be eligible to receive treatment in the non-randomized SBRT cohort.~SBRT"
70401|NCT02138578|O2|Outcome|Randomized RFA|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Radiofrequency Ablation (RFA) will receive RFA.~RFA"
70402|NCT02138578|O1|Outcome|Randomized SBRT|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Stereotactic Body Radiation Therapy (SBRT) will receive SBRT delivered in fractions of 20 Gy, approximately every other day, for a total of three treatments. If the target is deemed too close to organs at risk, 5 fractions of up to 10 Gy per fraction will be prescribed.~SBRT"
70403|NCT02138578|O3|Outcome|Non-Randomized SBRT|"Patients with renal cell carcinoma's greater than or equal to 4 cm in diameter, and up to 8 cm in diameter, may be placed in the non-randomized stereotactic body radiation therapy arm. Patients with tumors not amenable to RFA, those with metastatic disease, and those who elect a noninvasive means of treatment will also be eligible to receive treatment in the non-randomized SBRT cohort.~SBRT"
70404|NCT02138578|O2|Outcome|Randomized RFA|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Radiofrequency Ablation (RFA) will receive RFA.~RFA"
70405|NCT02138578|O1|Outcome|Randomized SBRT|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Stereotactic Body Radiation Therapy (SBRT) will receive SBRT delivered in fractions of 20 Gy, approximately every other day, for a total of three treatments. If the target is deemed too close to organs at risk, 5 fractions of up to 10 Gy per fraction will be prescribed.~SBRT"
70406|NCT02138578|O3|Outcome|Non-Randomized SBRT|"Patients with renal cell carcinoma's greater than or equal to 4 cm in diameter, and up to 8 cm in diameter, may be placed in the non-randomized stereotactic body radiation therapy arm. Patients with tumors not amenable to RFA, those with metastatic disease, and those who elect a noninvasive means of treatment will also be eligible to receive treatment in the non-randomized SBRT cohort.~SBRT"
70407|NCT02138578|O2|Outcome|Randomized RFA|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Radiofrequency Ablation (RFA) will receive RFA.~RFA"
70408|NCT02138578|O1|Outcome|Randomized SBRT|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Stereotactic Body Radiation Therapy (SBRT) will receive SBRT delivered in fractions of 20 Gy, approximately every other day, for a total of three treatments. If the target is deemed too close to organs at risk, 5 fractions of up to 10 Gy per fraction will be prescribed.~SBRT"
70465|NCT02138097|B12|Baseline|MS: Saxagliptin|Patients in the MarketScan (MS) cohort using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
70409|NCT02138578|O3|Outcome|Non-Randomized SBRT|"Patients with renal cell carcinoma's greater than or equal to 4 cm in diameter, and up to 8 cm in diameter, may be placed in the non-randomized stereotactic body radiation therapy arm. Patients with tumors not amenable to RFA, those with metastatic disease, and those who elect a noninvasive means of treatment will also be eligible to receive treatment in the non-randomized SBRT cohort.~SBRT"
70410|NCT02138578|O2|Outcome|Randomized RFA|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Radiofrequency Ablation (RFA) will receive RFA.~RFA"
70411|NCT02138578|O1|Outcome|Randomized SBRT|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Stereotactic Body Radiation Therapy (SBRT) will receive SBRT delivered in fractions of 20 Gy, approximately every other day, for a total of three treatments. If the target is deemed too close to organs at risk, 5 fractions of up to 10 Gy per fraction will be prescribed.~SBRT"
70412|NCT02138578|E3|Reported Event|Non-Randomized SBRT|"Patients with renal cell carcinoma's greater than or equal to 4 cm in diameter, and up to 8 cm in diameter, may be placed in the non-randomized stereotactic body radiation therapy arm. Patients with tumors not amenable to RFA, those with metastatic disease, and those who elect a noninvasive means of treatment will also be eligible to receive treatment in the non-randomized SBRT cohort.~SBRT"
70413|NCT02138578|E2|Reported Event|Randomized RFA|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Radiofrequency Ablation (RFA) will receive RFA.~RFA"
70414|NCT02138578|E1|Reported Event|Randomized SBRT|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Stereotactic Body Radiation Therapy (SBRT) will receive SBRT delivered in fractions of 20 Gy, approximately every other day, for a total of three treatments. If the target is deemed too close to organs at risk, 5 fractions of up to 10 Gy per fraction will be prescribed.~SBRT"
70415|NCT02138461|B3|Baseline|Total|Total of all reporting groups
70416|NCT02138461|B2|Baseline|Latanoprost Group|These patients take latanoprost topically for glaucoma.
70417|NCT02138461|B1|Baseline|Bimatoprost|These patients take bimatoprost topically for glaucoma.
70418|NCT02138461|P2|Participant Flow|Latanoprost Group|These patients take latanoprost topically for glaucoma.
70419|NCT02138461|P1|Participant Flow|Bimatoprost|These patients take bimatoprost topically for glaucoma.
70420|NCT02138461|O2|Outcome|Latanoprost Group|These patients take latanoprost topically for glaucoma.
70421|NCT02138461|O1|Outcome|Bimatoprost|These patients take bimatoprost topically for glaucoma.
70422|NCT02138461|E2|Reported Event|Latanoprost Group|These patients take latanoprost topically for glaucoma.
70423|NCT02138461|E1|Reported Event|Bimatoprost|These patients take bimatoprost topically for glaucoma.
70424|NCT02138227|B3|Baseline|Total|Total of all reporting groups
70425|NCT02138227|B2|Baseline|Autonomous CEaD Condition|In the autonomous condition, participants view the CEaD training materials on a DVD along with a self-training guide.
70426|NCT02138227|B1|Baseline|Assisted CEaD Condition|In the assisted condition, participants use the CEaD training materials supplemented with simulators to practice the communication skills.
70427|NCT02138227|P2|Participant Flow|Autonomous CEaD Condition|"In the autonomous condition, participants view the CEaD training materials on a DVD along with a self-training guide.~Autonomous CEaD Condition: In the autonomous condition, participants view the CEaD training materials on a DVD along with a self-training guide."
70428|NCT02138227|P1|Participant Flow|Assisted CEaD Condition|"In the assisted condition, participants use the CEaD training materials supplemented with simulators to practice the communication skills.~Assisted CEaD Condition: In the assisted condition, participants use the CEaD training materials supplemented with simulators to practice the communication skills. OPO requesters will be assisted by having the CEaD DVD supplemented through working the scenarios with live simulated patients who will be trained to act out the scenarios with the OPO requesters and provide feedback."
70429|NCT02138227|O9|Outcome|Senior Post-Intervention Requester Comfort (Assisted)|Mean level of comfort senior staff self-reported post-intervention in the assisted arm. Senior participants are defined has having more than 36 months of experience.
70430|NCT02138227|O8|Outcome|Senior Post-Intervention Requester Comfort (Autonomous)|Mean level of comfort senior staff self-reported post-intervention in the autonomous arm. Senior participants are defined has having more than 36 months of experience.
70431|NCT02138227|O7|Outcome|Senior Pre-Intevention Aggregate Requester Comfort|Mean level of comfort senior staff self-reported pre-intervention. Senior participants are defined has having more than 36 months of experience.
70432|NCT02138227|O6|Outcome|Mid-Level Post-Intervention Requester Comfort (Assisted)|Mean level of comfort mid-level staff self-reported post-intervention in the assisted arm. Mid-level participants are defined has having more 13 to 36 months of experience.
70433|NCT02138227|O5|Outcome|Mid-Level Post-Intervention Requester Comfort (Autonomous)|Mean level of comfort mid-level staff self-reported post-intervention in the autonomous arm. Mid-level participants are defined has having more 13 to 36 months of experience.
70434|NCT02138227|O4|Outcome|Mid-Level Pre-Intervention Aggregate Requester Comfort|Mean level of comfort mid-level staff self-reported pre-intervention. Mid-level participants are defined has having more 13 to 36 months of experience.
70435|NCT02138227|O3|Outcome|Novice Post-Intervention Requester Comfort (Assisted)|Mean level of comfort novice staff self-reported post-intervention in the assisted arm. Novice participants are defined has having less than 12 months of experience.
70436|NCT02138227|O2|Outcome|Novice Post-Intervention Requester Comfort (Autonomous)|Mean level of comfort novice staff self-reported post- intervention in the autonomous arm. Novice participants are defined has having less than 12 months of experience.
70437|NCT02138227|O1|Outcome|Novice Pre-Intevention Aggregate Requester Comfort|Mean level of comfort with novice staff self-reported pre-intervention. Novice participants are defined has having less than 12 months of experience.
70438|NCT02138227|O9|Outcome|Senior Post-Intervention Relational Communication (Assisted)|Mean of items measuring emotion, tone, and levels of sincerity, honesty, willingness to listen, and cooperation of senior requesters in the assisted post-intervention arm. Senior participants are defined has having more than 36 months of experience.
70440|NCT02138227|O7|Outcome|Senior Pre-Intervention Aggregate Relational Communication|Mean of items measuring emotion, tone, and levels of sincerity, honesty, willingness to listen, and cooperation of senior requesters pre-intervention. Senior participants are defined has having more than 36 months of experience.
70441|NCT02138227|O6|Outcome|Mid-Level Post-Intervention Relational Com (Assisted)|Mean of items measuring emotion, tone, and levels of sincerity, honesty, willingness to listen, and cooperation of mid-level requesters in the autonomous post-intervention arm. Mid-level participants are defined has having 13 to 36 months of experience.
70442|NCT02138227|O5|Outcome|Mid-Level Post Intervention Relational Com (Autonomous)|Mean of items measuring emotion, tone, and levels of sincerity, honesty, willingness to listen, and cooperation of mid-level autonomous post-intervention autonomous arm. Mid-level participants are defined has having 13 to 36 months of experience.
70443|NCT02138227|O4|Outcome|Mid-Level Pre-Intervention Aggregate Relational Communication|Mean of items measuring emotion, tone, and levels of sincerity, honesty, willingness to listen, and cooperation of mid-level requesters pre-intervention. Mid-level participants are defined has having 13 to 36 months of experience.
70444|NCT02138227|O3|Outcome|Novice Post-Intervention Relational Communication (Assisted)|Mean of items measuring emotion, tone, and levels of sincerity, honesty, willingness to listen, and cooperation of novice requesters in the assisted arm. Novice participants are defined has having less than 12 months of experience.
70445|NCT02138227|O2|Outcome|Novice Post-Intervention Relational Communication (Autonomous)|Mean of items measuring emotion, tone, and levels of sincerity, honesty, willingness to listen, and cooperation of novice requesters from the autonomous arm. Novice participants are defined has having less than 12 months of experience.
70446|NCT02138227|O1|Outcome|Novice Pre-Intervention Aggregate Relational Communication|Mean of items measuring emotion, tone, and levels of sincerity, honesty, willingness to listen, and cooperation of novice requesters pre-intervention. Novice participants are defined has having less than 12 months of experience.
70447|NCT02138227|O9|Outcome|Post-Authorization Rate (Senior Assisted Arm)|This is the authorization rate (successful authorization requests/total authorization requests) of participants in the assisted arm after the intervention. Senior participants are defined has having more than 36 months of experience.
70448|NCT02138227|O8|Outcome|Post-Intervention Authorization Rate (Senior Autonomous Arm)|This is the authorization rate (successful authorization requests/total authorization requests) of participants in the autonomous arm after the intervention. Senior participants are defined has having more than 36 months of experience.
70449|NCT02138227|O7|Outcome|Pre-Intervention Authorization Rate (All Senior)|This is the authorization rate (successful authorization requests/total authorization requests) of participants in aggregate before the intervention. Senior participants are defined has having more than 36 months of experience.
70450|NCT02138227|O6|Outcome|Post-Authorization Rate (Mid-Level Assisted Arm)|This is the authorization rate (successful authorization requests/total authorization requests) of participants in the assisted arm after the intervention. Mid-level participants are defined has having 13 to 36 months of experience.
70451|NCT02138227|O5|Outcome|Post-Intervention Authorization Rate(Mid-Level Autonomous Arm)|This is the authorization rate (successful authorization requests/total authorization requests) of participants in the autonomous arm after the intervention. Mid-level participants are defined has having 13 to 36 months of experience.
70452|NCT02138227|O4|Outcome|Pre-Intervention Authorization Rate (All Mid-Level)|This is the authorization rate (successful authorization requests/total authorization requests) of participants in aggregate before the intervention. Mid-level participants are defined has having 13 to 36 months of experience.
70453|NCT02138227|O3|Outcome|Post-Authorization Rate (Novice Assisted Arm)|This is the authorization rate (successful authorization requests/total authorization requests) of participants in the assisted arm after the intervention. Novice participants are defined has having less than 12 months of experience.
70454|NCT02138227|O2|Outcome|Post-Intervention Authorization Rate (Novice Autonomous Arm)|This is the authorization rate (successful authorization requests/total authorization requests) of participants in the autonomous arm after the intervention. Novice participants are defined has having less than 12 months of experience.
70455|NCT02138227|O1|Outcome|Pre-Intervention Authorization Rate (All Novice)|This is the authorization rate (successful authorization requests/total authorization requests) of participants in aggregate before the intervention. Novice participants are defined has having less than 12 months of experience.
70456|NCT02138227|E2|Reported Event|Autonomous CEaD Condition|"In the autonomous condition, participants view the CEaD training materials on a DVD along with a self-training guide.~Autonomous CEaD Condition: In the autonomous condition, participants view the CEaD training materials on a DVD along with a self-training guide."
70457|NCT02138227|E1|Reported Event|Assisted CEaD Condition|"In the assisted condition, participants use the CEaD training materials supplemented with simulators to practice the communication skills.~Assisted CEaD Condition: In the assisted condition, participants use the CEaD training materials supplemented with simulators to practice the communication skills. OPO requesters will be assisted by having the CEaD DVD supplemented through working the scenarios with live simulated patients who will be trained to act out the scenarios with the OPO requesters and provide feedback."
70458|NCT02138097|B19|Baseline|Total|Total of all reporting groups
70459|NCT02138097|B18|Baseline|MS: GLP-I RA|Patients in the MarketScan (MS) cohort using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
70460|NCT02138097|B17|Baseline|MS: Alpha-Glucosidase Inhibitors|Patients in the MarketScan (MS) cohort using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
70461|NCT02138097|B16|Baseline|MS: Meglitinides|Patients in the MarketScan (MS) cohort using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
70462|NCT02138097|B15|Baseline|MS: Glitazones|Patients in the MarketScan (MS) cohort using Glitazones as an oral and non-insulin injected glucose-lowering medication.
70463|NCT02138097|B14|Baseline|MS: Sulfonylurea|Patients in the MarketScan (MS) cohort using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
70464|NCT02138097|B13|Baseline|MS: Metformin|Patients in the MarketScan (MS) cohort using Metformin as an oral and non-insulin injected glucose-lowering medication.
70513|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
70469|NCT02138097|B8|Baseline|UHC: Alpha-Glucosidase Inhibitors|Patients in the United Healthcare cohort using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
70470|NCT02138097|B7|Baseline|UHC: Sulfonylurea|Patients in the United Healthcare cohort using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
70471|NCT02138097|B6|Baseline|UHC: Sitagliptin|Patients in the United Healthcare cohort using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
70472|NCT02138097|B5|Baseline|UHC: Saxagliptin|Patients in the United Healthcare cohort using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
70473|NCT02138097|B4|Baseline|UHC: Metformin|Patients in the United Healthcare cohort using Metformin as an oral and non-insulin injected glucose-lowering medication.
70474|NCT02138097|B3|Baseline|UHC: Meglitinides|Patients in the United Healthcare cohort using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
70475|NCT02138097|B2|Baseline|UHC: Linagliptin|Patients in the United Healthcare cohort using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
70476|NCT02138097|B1|Baseline|UHC: Glitazones|Patients in the United Healthcare cohort (UHC) using Glitazones as an oral and non-insulin injected glucose-lowering medication.
70477|NCT02138097|P2|Participant Flow|MarketScan|Patients using an oral and non-insulin injected glucose-lowering medication identified from the MarketScan database.
70478|NCT02138097|P1|Participant Flow|United Healthcare|Patients using an oral and non-insulin injected glucose-lowering medication identified from the United Healthcare Research database
70479|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
70480|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
70481|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
70482|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
70483|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
70484|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
70485|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
70486|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
70487|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
70488|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
70489|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
70490|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
70491|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
70492|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
70493|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
70494|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
70495|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
70496|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
70497|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
70498|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
70499|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
70500|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
70501|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
70502|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
70503|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
70504|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
70505|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
70506|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
70507|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
70508|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
70509|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
70510|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
70511|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
70512|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
70515|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
70516|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
70517|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
70518|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
70519|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
70520|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
70521|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
70522|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
70523|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
70524|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
70525|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
70526|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
70527|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
70528|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
70529|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
70530|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
70531|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
70532|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
70533|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
70534|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
70535|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
70536|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
70537|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
70538|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
70539|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
70540|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
70541|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
70542|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
70543|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
70544|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
70545|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
70546|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
70547|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
70548|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
70549|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
70550|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
70551|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
70552|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
70553|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
70554|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
70555|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
70556|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
70557|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
70558|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
70559|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
70560|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
70561|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
70562|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
70563|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
70564|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
70565|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
70566|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
70567|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
70568|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
70569|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
70570|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
70571|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
70572|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
70573|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
70574|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
70575|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
70576|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
70577|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
70578|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
70579|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
70580|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
70581|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
70582|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
70583|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
70584|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
70585|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
70586|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
70587|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
70588|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
70589|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
70590|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
70591|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
70592|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
70593|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
70594|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
70595|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
70596|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
70597|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
70598|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
70599|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
70600|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
70601|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
70602|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
70603|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
70604|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
70605|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
70606|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
70607|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
70608|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
70609|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
70610|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
70611|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
70612|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
70613|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
70614|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
70615|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
70616|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
70617|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
70618|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
70619|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
70620|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
70621|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
70622|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
70623|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
70624|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
70625|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
70626|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
70627|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
70628|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
70629|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
70630|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
70631|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
70632|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
70633|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
70634|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
70635|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
70636|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
70637|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
70638|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
70639|NCT02138097|O9|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
70640|NCT02138097|O8|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
70641|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
70642|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
70643|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
70644|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
70645|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
70646|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
70647|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
70648|NCT02138097|O9|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
70649|NCT02138097|O8|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
70650|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
70651|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
70652|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
70653|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
70654|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
70655|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
70656|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
70657|NCT02138097|E10|Reported Event|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
70658|NCT02138097|E9|Reported Event|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
70659|NCT02138097|E8|Reported Event|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
70660|NCT02138097|E7|Reported Event|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
70661|NCT02138097|E6|Reported Event|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
70662|NCT02138097|E5|Reported Event|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
70663|NCT02138097|E4|Reported Event|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
70664|NCT02138097|E3|Reported Event|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
70665|NCT02138097|E2|Reported Event|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
70666|NCT02138097|E1|Reported Event|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
70667|NCT02138006|B3|Baseline|Total|Total of all reporting groups
70668|NCT02138006|B2|Baseline|Standard Insulin Treatment|"Standard insulin treatment~Standard insulin treatment"
70669|NCT02138006|B1|Baseline|Intensive Insulin Treatment|"Intensive insulin treatment~Intensive insulin treatment"
70670|NCT02138006|P2|Participant Flow|Standard Insulin Treatment|"Standard insulin treatment~Standard insulin treatment"
70671|NCT02138006|P1|Participant Flow|Intensive Insulin Treatment|"Intensive insulin treatment~Intensive insulin treatment"
70672|NCT02138006|O2|Outcome|Standard Insulin Treatment|"Standard insulin treatment~Standard insulin treatment"
70673|NCT02138006|O1|Outcome|Intensive Insulin Treatment|"Intensive insulin treatment~Intensive insulin treatment"
70674|NCT02138006|O2|Outcome|Standard Insulin Treatment|"Standard insulin treatment~Standard insulin treatment"
70675|NCT02138006|O1|Outcome|Intensive Insulin Treatment|"Intensive insulin treatment~Intensive insulin treatment"
70676|NCT02138006|E2|Reported Event|Standard Insulin Treatment|"Standard insulin treatment~Standard insulin treatment"
70677|NCT02138006|E1|Reported Event|Intensive Insulin Treatment|"Intensive insulin treatment~Intensive insulin treatment"
70678|NCT02137785|B3|Baseline|Total|Total of all reporting groups
70679|NCT02137785|B2|Baseline|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70680|NCT02137785|B1|Baseline|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70681|NCT02137785|P2|Participant Flow|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70682|NCT02137785|P1|Participant Flow|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70683|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70684|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70685|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70686|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70687|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70688|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70689|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70690|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70691|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
71247|NCT02135016|P3|Participant Flow|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
70692|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70693|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70694|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70695|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70696|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70697|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70698|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70699|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70700|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70701|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70702|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70703|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70704|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70705|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70706|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70707|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70708|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70709|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70710|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70711|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70712|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70713|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70714|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70715|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70716|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70717|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70718|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
71040|NCT02135848|O3|Outcome|GSK1278863 15 mg|Eligible participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
70719|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70720|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70721|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70722|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70723|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70724|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70725|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70726|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70727|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70728|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70729|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70730|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70731|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70732|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70733|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70734|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70735|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70736|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70737|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70738|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70739|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70740|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70741|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70742|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70743|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70744|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70745|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
75582|NCT02109484|O1|Outcome|Cohort B Placebo|Healthy Infants aged 6 to <8 weeks receiving placebo
70746|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70747|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70748|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70749|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70750|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70751|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70752|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70753|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70754|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70755|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70756|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70757|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70758|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70759|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70760|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70761|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70762|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70763|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70764|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70765|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70766|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70767|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70768|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70769|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70770|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70771|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70772|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
71041|NCT02135848|O2|Outcome|Placebo Matched With GSK1278863 300 mg|Eligible participants received single dose of placebo matched with 300 mg GSK1278863 tablets orally.
70773|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70774|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70775|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70776|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70777|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70778|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70779|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70780|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70781|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70782|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70783|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70784|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70785|NCT02137785|E2|Reported Event|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70786|NCT02137785|E1|Reported Event|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
70787|NCT02137772|B3|Baseline|Total|Total of all reporting groups
70788|NCT02137772|B2|Baseline|Placebo|Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
70789|NCT02137772|B1|Baseline|Letermovir|Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
70790|NCT02137772|P2|Participant Flow|Placebo|Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
70791|NCT02137772|P1|Participant Flow|Letermovir|Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
70792|NCT02137772|O2|Outcome|Placebo|Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
70793|NCT02137772|O1|Outcome|Letermovir|Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
70794|NCT02137772|O2|Outcome|Placebo|Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
70874|NCT02137226|O1|Outcome|BI 695501|Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 solution for injection, administered by subcutaneous (SC) injection every 2 weeks up to and including the first 22 weeks of treatment (Period 1).
70795|NCT02137772|O1|Outcome|Letermovir|Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
70796|NCT02137772|O2|Outcome|Placebo|Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
70797|NCT02137772|O1|Outcome|Letermovir|Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
70798|NCT02137772|O2|Outcome|Placebo|Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
70799|NCT02137772|O1|Outcome|Letermovir|Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
70800|NCT02137772|O2|Outcome|Placebo|Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
70801|NCT02137772|O1|Outcome|Letermovir|Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
70802|NCT02137772|O2|Outcome|Placebo|Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
70803|NCT02137772|O1|Outcome|Letermovir|Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
70804|NCT02137772|O2|Outcome|Placebo|Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
70805|NCT02137772|O1|Outcome|Letermovir|Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
70806|NCT02137772|O2|Outcome|Placebo|Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
70807|NCT02137772|O1|Outcome|Letermovir|Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
70808|NCT02137772|O2|Outcome|Placebo|Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
70809|NCT02137772|O1|Outcome|Letermovir|Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
70810|NCT02137772|O2|Outcome|Placebo|Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
70811|NCT02137772|O1|Outcome|Letermovir|Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
70812|NCT02137772|E2|Reported Event|Placebo|Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
70813|NCT02137772|E1|Reported Event|Letermovir|Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
70814|NCT02137603|B3|Baseline|Total|Total of all reporting groups
70815|NCT02137603|B2|Baseline|Admission|Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
70816|NCT02137603|B1|Baseline|Fast Track|"Patients discharged home the same day following appendectomy~Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics."
70817|NCT02137603|P2|Participant Flow|Admission|Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
70818|NCT02137603|P1|Participant Flow|Fast Track|"Patients discharged home the same day following appendectomy~Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics."
70819|NCT02137603|O2|Outcome|Admission|Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
70820|NCT02137603|O1|Outcome|Fast Track|"Patients discharged home the same day following appendectomy~Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics."
70821|NCT02137603|O2|Outcome|Admission|Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
70822|NCT02137603|O1|Outcome|Fast Track|"Patients discharged home the same day following appendectomy~Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics."
70823|NCT02137603|E2|Reported Event|Admission|Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
70824|NCT02137603|E1|Reported Event|Fast Track|"Patients discharged home the same day following appendectomy~Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics."
70825|NCT02137512|B1|Baseline|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
70826|NCT02137512|P1|Participant Flow|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
70827|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
70828|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
70875|NCT02137226|O2|Outcome|US-licensed Humira® Continuously|Humira® US continuously comprised all patients randomized to US-licensed Humira® in Period 1 and re-randomized to US-licensed Humira® in Period 2 or not re randomized at Week 24 (e.g. patients who discontinued treatment prior to Week 24). This group represents all patients who were to receive US-licensed Humira® from Day 1 to Week 48. Each patient received 40 mg/0.8 mL US-licensed Humira® solution for injection, administered by SC injection every 2 weeks.
71248|NCT02135016|P2|Participant Flow|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
70829|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
70830|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
70831|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
70832|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
70833|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
70834|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
70835|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
70836|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
70837|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
70838|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
71042|NCT02135848|O1|Outcome|GSK1278863 300 mg|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally.
70839|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
70840|NCT02137512|E1|Reported Event|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
70841|NCT02137447|B1|Baseline|Treatment Group|Negative Pressure treatment
70842|NCT02137447|P1|Participant Flow|Negative Pressure Wound Therapy|"After the completion of the operation, incisional skin closure was performed using sutures or staples and the wound was then covered with the Negative Pressure Wound therapy Prevena Incision Management System (Kinetic Concepts Inc) as per the manufacturer's instructions of use. Continuous negative pressure was applied at 125 mm Hg.~For inpatients, wounds were assessed every 48 hours by inspection and palpation. The dressing was not routinely removed, but the surrounding skin was assessed for cellulitis. The NPWT dressing was removed between post-operative day 5 and 7."
70843|NCT02137447|O1|Outcome|Treatment Group|Negative Pressure Wound Therapy (NPWT) to closed surgical incision
70844|NCT02137447|O1|Outcome|Treatment Group|Negative Pressure Wound Therapy (NPWT) to closed surgical incision
70845|NCT02137447|E1|Reported Event|Treatment Group|Negative Pressure Wound Therapy (NPWT) to closed surgical incision
70846|NCT02137382|B1|Baseline|Sequence Creon N/Creon® or Creon®/Creon N|Participants who were randomized to receive either Creon N or Creon.
70847|NCT02137382|P2|Participant Flow|Sequence: Creon®/Creon N|Subjects first received Creon® for 5 days. After a washout period of 3 to 14 days, they received Creon N for 5 days. The Investigator calculated the total number of capsules per day needed to treat the subject with 8000 to <10000 lipase units per kg body weight and day, Capsules of both Creon N and Creon® contain 25000 lipase units.
70848|NCT02137382|P1|Participant Flow|Sequence: Creon N/Creon®|Subjects first received Creon N for 5 days. After a washout period of 3 to 14 days, they received Creon® for 5 days. The Investigator calculated the total number of capsules per day needed to treat the subject with 8000 to <10000 lipase units per kg body weight and day, Capsules of both Creon N and Creon® contain 25000 lipase units.
70849|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
70850|NCT02137382|O1|Outcome|Creon®|Creon®: active comparator
70851|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
70852|NCT02137382|O1|Outcome|Creon®|Creon®: active comparator
70853|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
70854|NCT02137382|O1|Outcome|Creon®|Creon®: active comparator
70855|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
70856|NCT02137382|O1|Outcome|Creon®|Creon®: active comparator
70857|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
70858|NCT02137382|O1|Outcome|Creon®|Creon® : active comparator
70859|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
70860|NCT02137382|O1|Outcome|Creon®|Creon®: active comparator
70861|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
70862|NCT02137382|O1|Outcome|Creon®|Creon®: active comparator
70863|NCT02137382|E2|Reported Event|Creon N|Creon N: experimental drug
70864|NCT02137382|E1|Reported Event|Creon®|Creon®: active comparator
70865|NCT02137226|B3|Baseline|Total|Total of all reporting groups
70866|NCT02137226|B2|Baseline|US-licensed Humira®|Each patient received 40 mg/0.8 mL US-licenced Humira® solution for injection, administered by SC injection every 2 weeks up to and including the first 22 weeks of treatment (Period 1).
70867|NCT02137226|B1|Baseline|BI 695501|Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 solution for injection, administered by subcutaneous (SC) injection every 2 weeks up to and including the first 22 weeks of treatment (Period 1).
70868|NCT02137226|P5|Participant Flow|US-licensed Humira® to BI 695501|Patients initially randomized to US-licensed Humira® in Period 1 and re-randomized to BI 695501 in Period 2. Each patient received 40 mg/0.8 mL US-licenced Humira® in period 1 and 40 mg/0.8 mL BI 695501 solution for injection, administered by SC injection every 2 weeks from Week 24 to Week 48.
70869|NCT02137226|P4|Participant Flow|US-licensed Humira® to US-licensed Humira®|Patients initially randomized to US-licensed Humira® in Period 1 and re-randomized to US-licensed Humira® in Period 2. Each patient received 40 mg/0.8 mL US-licenced Humira® solution for injection, administered by SC injection every 2 weeks from Week 24 to Week 48.
70870|NCT02137226|P3|Participant Flow|BI 695501 to BI 695501|Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2. Each patient received 40 mg/0.8 mL BI 695501 solution for injection, administered by SC injection every 2 weeks from Week 24 to Week 48.
70871|NCT02137226|P2|Participant Flow|US-licensed Humira®|Each patient received 40 mg/0.8 mL US-licenced Humira® solution for injection, administered by SC injection every 2 weeks up to and including the first 22 weeks of treatment (Period 1).
70872|NCT02137226|P1|Participant Flow|BI 695501|Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 solution for injection, administered by subcutaneous (SC) injection every 2 weeks up to and including the first 22 weeks of treatment (Period 1).
70873|NCT02137226|O2|Outcome|US-licensed Humira®|Each patient received 40 mg/0.8 mL US-licenced Humira® solution for injection, administered by SC injection every 2 weeks up to and including the first 22 weeks of treatment (Period 1).
71243|NCT02135016|B4|Baseline|Total|Total of all reporting groups
70876|NCT02137226|O1|Outcome|BI 695501 Continuously|BI 695501 continuously comprised all patients randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 (or not re randomized at Week 24). This group represents all patients who were to receive BI 695501 from Day 1 to Week 48. Each patient received 40 mg/0.8 mL BI 695501 solution for injection, administered by SC injection every 2 weeks.
70877|NCT02137226|O2|Outcome|US-licensed Humira®|Each patient received 40 mg/0.8 mL US-licenced Humira® solution for injection, administered by SC injection every 2 weeks up to and including the first 22 weeks of treatment (Period 1).
70878|NCT02137226|O1|Outcome|BI 695501|Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 solution for injection, administered by subcutaneous (SC) injection every 2 weeks up to and including the first 22 weeks of treatment (Period 1).
70879|NCT02137226|O2|Outcome|US-licensed Humira®|Each patient received 40 mg/0.8 mL US-licenced Humira® solution for injection, administered by SC injection every 2 weeks up to and including the first 22 weeks of treatment (Period 1).
70880|NCT02137226|O1|Outcome|BI 695501|Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 solution for injection, administered by subcutaneous (SC) injection every 2 weeks up to and including the first 22 weeks of treatment (Period 1).
70881|NCT02137226|E2|Reported Event|US-licensed Humira® Continuously|Humira® US continuously comprised all patients randomized to US-licensed Humira® in Period 1 and re-randomized to US-licensed Humira® in Period 2 or not re randomized at Week 24 (e.g. patients who discontinued treatment prior to Week 24). This group represents all patients who were to receive US-licensed Humira® from Day 1 to Week 48. Each patient received 40 mg/0.8 mL US-licensed Humira® solution for injection, administered by SC injection every 2 weeks.
70882|NCT02137226|E1|Reported Event|BI 695501 Continuously|BI 695501 continuously comprised all patients randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 (or not re randomized at Week 24). This group represents all patients who were to receive BI 695501 from Day 1 to Week 48. Each patient received 40 mg/0.8 mL BI 695501 solution for injection, administered by SC injection every 2 weeks.
70883|NCT02136914|B3|Baseline|Total|Total of all reporting groups
70884|NCT02136914|B2|Baseline|ADS-5102 (340 mg)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 25 weeks
70885|NCT02136914|B1|Baseline|Placebo|Placebo: oral capsules administered once nightly at bedtime for 25 weeks
70886|NCT02136914|P2|Participant Flow|ADS-5102 (340 mg)|340 mg dose of ADS-5102 (amantadine hydrochloride [HCl] extended release): oral capsules administered once nightly at bedtime for 25 weeks
70887|NCT02136914|P1|Participant Flow|Placebo|Placebo: oral capsules administered once nightly at bedtime for 25 weeks
70888|NCT02136914|O2|Outcome|ADS-5102 (340 mg)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 25 weeks
70889|NCT02136914|O1|Outcome|Placebo|Placebo: oral capsules administered once nightly at bedtime for 25 weeks
70890|NCT02136914|O2|Outcome|ADS-5102 (340 mg)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 25 weeks
70891|NCT02136914|O1|Outcome|Placebo|Placebo: oral capsules administered once nightly at bedtime for 25 weeks
70892|NCT02136914|O2|Outcome|ADS-5102 (340 mg)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 25 weeks
70893|NCT02136914|O1|Outcome|Placebo|Placebo: oral capsules administered once nightly at bedtime for 25 weeks
70894|NCT02136914|O2|Outcome|ADS-5102 (340 mg)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 25 weeks
70895|NCT02136914|O1|Outcome|Placebo|Placebo: oral capsules administered once nightly at bedtime for 25 weeks
70896|NCT02136914|O2|Outcome|ADS-5102 (340 mg)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 25 weeks
70897|NCT02136914|O1|Outcome|Placebo|Placebo: oral capsules administered once nightly at bedtime for 25 weeks
70898|NCT02136914|E2|Reported Event|ADS-5102 (340 mg)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 25 weeks
70899|NCT02136914|E1|Reported Event|Placebo|Placebo: oral capsules administered once nightly at bedtime for 25 weeks
70900|NCT02136498|B3|Baseline|Total|Total of all reporting groups
70901|NCT02136498|B2|Baseline|mHealth MyMAP + Varenicline|"Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline.~The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor."
70902|NCT02136498|B1|Baseline|mHealth Self-help + Varenicline|"Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline.~Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc."
70903|NCT02136498|P2|Participant Flow|mHealth MyMAP + Varenicline|"Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline.~The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor."
70904|NCT02136498|P1|Participant Flow|mHealth Self-help + Varenicline|"Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline.~Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc."
70905|NCT02136498|O2|Outcome|Augmented mHealth Self-help + Varenicline|"Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline.~The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor."
70906|NCT02136498|O1|Outcome|mHealth Self-help + Varenicline|"Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline.~Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc."
70907|NCT02136498|O2|Outcome|Augmented mHealth Self-help + Varenicline|"Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline.~The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor."
70908|NCT02136498|O1|Outcome|mHealth Self-help + Varenicline|"Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline.~Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc."
70909|NCT02136498|E2|Reported Event|mHealth MyMAP + Varenicline|"Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline.~The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor."
70910|NCT02136498|E1|Reported Event|mHealth Self-help + Varenicline|"Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline.~Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc."
70911|NCT02136420|B5|Baseline|Total|Total of all reporting groups
70912|NCT02136420|B4|Baseline|Perceptual Thresholds,Placebo Then Drug|"Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with placebo then once with promethazine, separated by >4 days.~Promethazine: Subject receives promethazine~Placebo: Placebo"
70913|NCT02136420|B3|Baseline|Perceptual Thresholds,Drug Then Placebo|"Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with promethazine then once with placebo, separated by >4 days.~Promethazine: Subject receives promethazine~Placebo: Placebo"
70914|NCT02136420|B2|Baseline|Manual Control, Training, Placebo|"placebo~Hyper gravity training: Subject receives hypergravity training before testing~Placebo: Placebo"
70915|NCT02136420|B1|Baseline|Tilt Perception, Training, Placebo|"placebo~Hyper gravity training: Subject receives hypergravity training before testing~Placebo: Placebo"
70916|NCT02136420|P10|Participant Flow|Perceptual Thresholds,Placebo Then Drug|"Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with placebo then once with promethazine, separated by >4 days.~This arm corresponds to results published in Diaz-Artiles et al 2017."
70917|NCT02136420|P9|Participant Flow|Perceptual Thresholds,Drug Then Placebo|"Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with promethazine then once with placebo, separated by >4 days.~This arm corresponds to results published in Diaz-Artiles et al 2017."
70918|NCT02136420|P8|Participant Flow|Manual Control,No Training,Promethazine|promethazine 25 mg, one time 120 minutes prior to experiment
70919|NCT02136420|P7|Participant Flow|Manual Control, Training, Promethazine|promethazine 25 mg, one time 120 minutes prior to experiment
70920|NCT02136420|P6|Participant Flow|Manual Control, No Training, Placebo|subject does test with no hyper gravity training and placebo drug only
70921|NCT02136420|P5|Participant Flow|Manual Control, Training, Placebo|placebo
70922|NCT02136420|P4|Participant Flow|Tilt Perception,No Training,Promethazine|promethazine 25 mg, one time 120 minutes prior to experiment. No hypergravity training
70923|NCT02136420|P3|Participant Flow|Tilt Perception, Training, Promethazine|promethazine 25 mg, one time 120 minutes prior to experiment
70924|NCT02136420|P2|Participant Flow|Tilt Perception, No Training, Placebo|subject does test with no hypergravity training and placebo drug only
70925|NCT02136420|P1|Participant Flow|Tilt Perception, Training, Placebo|placebo
70926|NCT02136420|O1|Outcome|Training, Placebo|"placebo~Hyper gravity training: Subject receives hypergravity training before testing~Placebo: Placebo"
70927|NCT02136420|O2|Outcome|Perceptual Thresholds,Placebo Then Drug|Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with placebo then once with promethazine, separated by >4 days.
70928|NCT02136420|O1|Outcome|Perceptual Thresholds,Drug Then Placebo|"Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with promethazine then once with placebo, separated by >4 days.~Promethazine: Subject receives promethazine~Placebo: Placebo"
70929|NCT02136420|O2|Outcome|Perceptual Thresholds,Placebo Then Drug|Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with placebo then once with promethazine, separated by >4 days.
70930|NCT02136420|O1|Outcome|Perceptual Thresholds,Drug Then Placebo|"Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with promethazine then once with placebo, separated by >4 days.~Promethazine: Subject receives promethazine~Placebo: Placebo"
70986|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
70931|NCT02136420|O2|Outcome|Perceptual Thresholds,Placebo Then Drug|Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with placebo then once with promethazine, separated by >4 days.
70932|NCT02136420|O1|Outcome|Perceptual Thresholds,Drug Then Placebo|"Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with promethazine then once with placebo, separated by >4 days.~Promethazine: Subject receives promethazine~Placebo: Placebo"
70933|NCT02136420|O1|Outcome|Training, Placebo|"placebo~Hyper gravity training: Subject receives hypergravity training before testing~Placebo: Placebo"
70934|NCT02136420|E10|Reported Event|Manual Control, No Training, Promethazine|
70935|NCT02136420|E9|Reported Event|Manual Control, Training, Promethazine|
70936|NCT02136420|E8|Reported Event|Manual Control, No Training, Placebo|
70937|NCT02136420|E7|Reported Event|Manual Control, Training, Placebo|
70938|NCT02136420|E6|Reported Event|Perceptual Motion Threshold Testing: Placebo|
70939|NCT02136420|E5|Reported Event|Perceptual Threshold Testing: Promethazine|
70940|NCT02136420|E4|Reported Event|Tilt Perception, No Training, Promethazine|
70941|NCT02136420|E3|Reported Event|Tilt Perception, Training, Promethazine|
70942|NCT02136420|E2|Reported Event|Tilt Perception, No Training, Placebo|
70943|NCT02136420|E1|Reported Event|Tilt Perception, Training, Placebo|
70944|NCT02136238|B3|Baseline|Total|Total of all reporting groups
70945|NCT02136238|B2|Baseline|Experimental Group: Unilateral TR or Wrist-disartic Amputees|Includes groups randomized to receive either TRS Grip 3 voluntary close device or Hosmer 5XA voluntary open device first.
70946|NCT02136238|B1|Baseline|Non-amputee Control Group|non-amputee healthy controls
70947|NCT02136238|P3|Participant Flow|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
70948|NCT02136238|P2|Participant Flow|Voluntary Close Device First Then Voluntary Open Device|Voluntary close device (TRS Grip 3 terminal device) first then voluntary open device (Hosmer 5X hook terminal device)
70949|NCT02136238|P1|Participant Flow|Voluntary Open Device First Then Voluntary Close Device|Voluntary open device (Hosmer 5X hook terminal device) first then voluntary close device (TRS Grip 3 terminal device)
70950|NCT02136238|O3|Outcome|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
70951|NCT02136238|O2|Outcome|Voluntary Close (TRS Grip 3)|This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 2
70952|NCT02136238|O1|Outcome|Voluntary Open (Hosmer 5XA)|This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1
70953|NCT02136238|O3|Outcome|Non-amputee Controls|This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.
70954|NCT02136238|O2|Outcome|Prosthetic Hand 2 (TRS Grip 3)|"This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 2~TRS Grip 3 voluntary closing hook: Voluntary closing prosthetic terminal device (hand)"
70955|NCT02136238|O1|Outcome|Prosthetic Hand 1 (Hosmer 5XA)|"This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1~Hosmer 5XA voluntary opening hook: Voluntary opening prosthetic terminal device (hand)"
70956|NCT02136238|E3|Reported Event|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
70957|NCT02136238|E2|Reported Event|Voluntary Close (TRS Grip 3)|This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 2
70958|NCT02136238|E1|Reported Event|Voluntary Open (Hosmer 5XA)|This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1
70959|NCT02136134|B3|Baseline|Total|Total of all reporting groups
70960|NCT02136134|B2|Baseline|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
70961|NCT02136134|B1|Baseline|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
70962|NCT02136134|P2|Participant Flow|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
70963|NCT02136134|P1|Participant Flow|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
70964|NCT02136134|O2|Outcome|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
70965|NCT02136134|O1|Outcome|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
70966|NCT02136134|O2|Outcome|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
70967|NCT02136134|O1|Outcome|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
70968|NCT02136134|O2|Outcome|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
70969|NCT02136134|O1|Outcome|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
70970|NCT02136134|O2|Outcome|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
70971|NCT02136134|O1|Outcome|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
70972|NCT02136134|O2|Outcome|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
70973|NCT02136134|O1|Outcome|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
70974|NCT02136134|O2|Outcome|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
70975|NCT02136134|O1|Outcome|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
70976|NCT02136134|E2|Reported Event|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
70977|NCT02136134|E1|Reported Event|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
70978|NCT02136004|B3|Baseline|Total|Total of all reporting groups
70979|NCT02136004|B2|Baseline|Closer VSS - Interventional Cohort|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomies in interventional endovascular cases.~Closer VSS: At the end of a percutaneous interventional endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
70980|NCT02136004|B1|Baseline|Closer VSS - Diagnostic Cohort|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomies in diagnostic endovascular cases.~Closer VSS: At the end of a percutaneous diagnostic endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
70981|NCT02136004|P1|Participant Flow|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
70982|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
70983|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
70984|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
70985|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
71039|NCT02135848|O4|Outcome|Placebo Matched With GSK1278863 15 mg|Eligible participants received placebo matched with 15 mg GSK1278863 tablets orally once daily for 14 days.
70987|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
70988|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
70989|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
70990|NCT02136004|E1|Reported Event|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
70991|NCT02135900|B1|Baseline|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.~Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
70992|NCT02135900|P1|Participant Flow|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.~Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
70993|NCT02135900|O1|Outcome|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.~Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
70994|NCT02135900|O1|Outcome|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.~Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
70995|NCT02135900|O1|Outcome|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.~Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
70996|NCT02135900|O1|Outcome|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.~Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
70997|NCT02135900|E1|Reported Event|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.~Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
70998|NCT02135848|B3|Baseline|Total|Total of all reporting groups
70999|NCT02135848|B2|Baseline|Placebo|Eligible participants received single dose of placebo matched with 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received placebo matched with 15 mg GSK1278863 tablets orally once daily for 14 days.
71000|NCT02135848|B1|Baseline|GSK1278863|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
71001|NCT02135848|P2|Participant Flow|Placebo|Eligible participants received single dose of placebo matched with 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received placebo matched with 15 mg GSK1278863 tablets orally once daily for 14 days.
71002|NCT02135848|P1|Participant Flow|GSK1278863|Eligible participants received an initial single high dose of 300 milligram (mg) GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
71003|NCT02135848|O4|Outcome|Placebo Matched With GSK1278863 15 mg|Eligible participants received placebo matched with 15 mg GSK1278863 tablets orally once daily for 14 days.
71004|NCT02135848|O3|Outcome|GSK1278863 15 mg|Eligible participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
71005|NCT02135848|O2|Outcome|Placebo Matched With GSK1278863 300 mg|Eligible participants received single dose of placebo matched with 300 mg GSK1278863 tablets orally.
71006|NCT02135848|O1|Outcome|GSK1278863 300 mg|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally.
71007|NCT02135848|O2|Outcome|GSK1278863 15 mg|Eligible participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
71008|NCT02135848|O1|Outcome|GSK1278863 300 mg|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally.
71009|NCT02135848|O2|Outcome|GSK1278863 15 mg|Eligible participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
71010|NCT02135848|O1|Outcome|GSK1278863 300 mg|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally.
71011|NCT02135848|O2|Outcome|GSK1278863 15 mg|Eligible participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
71012|NCT02135848|O1|Outcome|GSK1278863 300 mg|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally.
71013|NCT02135848|O2|Outcome|Placebo|Eligible participants received placebo matched with 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received placebo matched with 15 mg GSK1278863 tablets orally once daily for 14 days.
71014|NCT02135848|O1|Outcome|GSK1278863|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
71015|NCT02135848|O2|Outcome|Placebo|Eligible participants received placebo matched with 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received placebo matched with 15 mg GSK1278863 tablets orally once daily for 14 days.
71016|NCT02135848|O1|Outcome|GSK1278863|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
71017|NCT02135848|O2|Outcome|Placebo|Eligible participants received placebo matched with 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received placebo matched with 15 mg GSK1278863 tablets orally once daily for 14 days.
71018|NCT02135848|O1|Outcome|GSK1278863|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
71019|NCT02135848|O2|Outcome|Placebo|Eligible participants received placebo matched with 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received placebo matched with 15 mg GSK1278863 tablets orally once daily for 14 days.
71020|NCT02135848|O1|Outcome|GSK1278863|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
71021|NCT02135848|O2|Outcome|Placebo|Eligible participants received placebo matched with 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received placebo matched with 15 mg GSK1278863 tablets orally once daily for 14 days.
71022|NCT02135848|O1|Outcome|GSK1278863|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
71023|NCT02135848|O2|Outcome|Placebo|Eligible participants received placebo matched with 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received placebo matched with 15 mg GSK1278863 tablets orally once daily for 14 days.
71024|NCT02135848|O1|Outcome|GSK1278863|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
71025|NCT02135848|O2|Outcome|Placebo|Eligible participants received placebo matched with 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received placebo matched with 15 mg GSK1278863 tablets orally once daily for 14 days.
71026|NCT02135848|O1|Outcome|GSK1278863|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
71027|NCT02135848|O2|Outcome|Placebo|Eligible participants received placebo matched with 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received placebo matched with 15 mg GSK1278863 tablets orally once daily for 14 days.
71028|NCT02135848|O1|Outcome|GSK1278863|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
71029|NCT02135848|O2|Outcome|Placebo|Eligible participants received placebo matched with 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received placebo matched with 15 mg GSK1278863 tablets orally once daily for 14 days.
71030|NCT02135848|O1|Outcome|GSK1278863|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
71031|NCT02135848|O2|Outcome|Placebo|Eligible participants received placebo matched with 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received placebo matched with 15 mg GSK1278863 tablets orally once daily for 14 days.
71032|NCT02135848|O1|Outcome|GSK1278863|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
71033|NCT02135848|O2|Outcome|Placebo|Eligible participants received placebo matched with 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received placebo matched with 15 mg GSK1278863 tablets orally once daily for 14 days.
71034|NCT02135848|O1|Outcome|GSK1278863|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
71035|NCT02135848|O2|Outcome|Placebo|Eligible participants received placebo matched with 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received placebo matched with 15 mg GSK1278863 tablets orally once daily for 14 days.
71036|NCT02135848|O1|Outcome|GSK1278863|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
71037|NCT02135848|O2|Outcome|Placebo|Eligible participants received placebo matched with 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received placebo matched with 15 mg GSK1278863 tablets orally once daily for 14 days.
71038|NCT02135848|O1|Outcome|GSK1278863|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally followed by a 14-day washout period. After completing the washout period, participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
71043|NCT02135848|O4|Outcome|Placebo Matched With GSK1278863 15 mg|Eligible participants received placebo matched with 15 mg GSK1278863 tablets orally once daily for 14 days.
71044|NCT02135848|O3|Outcome|GSK1278863 15 mg|Eligible participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
71045|NCT02135848|O2|Outcome|Placebo Matched With GSK1278863 300 mg|Eligible participants received single dose of placebo matched with 300 mg GSK1278863 tablets orally.
71046|NCT02135848|O1|Outcome|GSK1278863 300 mg|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally.
71047|NCT02135848|O4|Outcome|Placebo Matched With GSK1278863 15 mg|Eligible participants received placebo matched with 15 mg GSK1278863 tablets orally once daily for 14 days.
71048|NCT02135848|O3|Outcome|GSK1278863 15 mg|Eligible participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
71049|NCT02135848|O2|Outcome|Placebo Matched With GSK1278863 300 mg|Eligible participants received single dose of placebo matched with 300 mg GSK1278863 tablets orally.
71050|NCT02135848|O1|Outcome|GSK1278863 300 mg|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally.
71051|NCT02135848|O4|Outcome|Placebo Matched With GSK1278863 15 mg|Eligible participants received placebo matched with 15 mg GSK1278863 tablets orally once daily for 14 days.
71052|NCT02135848|O3|Outcome|GSK1278863 15 mg|Eligible participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
71053|NCT02135848|O2|Outcome|Placebo Matched With GSK1278863 300 mg|Eligible participants received single dose of placebo matched with 300 mg GSK1278863 tablets orally.
71054|NCT02135848|O1|Outcome|GSK1278863 300 mg|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally.
71055|NCT02135848|E4|Reported Event|Placebo Matched With GSK1278863 15 mg|Eligible participants received placebo matched with 15 mg GSK1278863 tablets orally for 14 days.
71056|NCT02135848|E3|Reported Event|GSK1278863 15 mg|Eligible participants received repeated dose of 15 mg GSK1278863 tablets orally once daily for 14 days.
71057|NCT02135848|E2|Reported Event|Placebo Matched With GSK1278863 300 mg|Eligible participants received single dose of placebo matched with 300 mg GSK1278863 tablets orally.
71058|NCT02135848|E1|Reported Event|GSK1278863 300 mg|Eligible participants received an initial single high dose of 300 mg GSK1278863 tablets orally.
71059|NCT02135692|B1|Baseline|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
71060|NCT02135692|P1|Participant Flow|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
71061|NCT02135692|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
71062|NCT02135692|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
71063|NCT02135692|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
71064|NCT02135692|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
71065|NCT02135692|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
71066|NCT02135692|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
71067|NCT02135692|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
71068|NCT02135692|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
71069|NCT02135692|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
71070|NCT02135692|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
71071|NCT02135692|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
71072|NCT02135692|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
71073|NCT02135692|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
71074|NCT02135692|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
71075|NCT02135692|E1|Reported Event|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
71076|NCT02135614|B3|Baseline|Total|Total of all reporting groups
71077|NCT02135614|B2|Baseline|Placebo|Single dose of placebo tablets
71078|NCT02135614|B1|Baseline|Presatovir|Single dose of presatovir 200 mg (4 x 50 mg tablets)
71079|NCT02135614|P2|Participant Flow|Placebo|Single dose of placebo tablets
71080|NCT02135614|P1|Participant Flow|Presatovir|Single dose of presatovir 200 mg (4 x 50 mg tablets)
71081|NCT02135614|O2|Outcome|Placebo|Single dose of placebo tablets
71082|NCT02135614|O1|Outcome|Presatovir|Single dose of presatovir 200 mg (4 x 50 mg tablets)
71083|NCT02135614|O2|Outcome|Placebo|Single dose of placebo tablets
71084|NCT02135614|O1|Outcome|Presatovir|Single dose of presatovir 200 mg (4 x 50 mg tablets)
71085|NCT02135614|O2|Outcome|Placebo|Single dose of placebo tablets
71086|NCT02135614|O1|Outcome|Presatovir|Single dose of presatovir 200 mg (4 x 50 mg tablets)
71087|NCT02135614|O2|Outcome|Placebo|Single dose of placebo tablets
71088|NCT02135614|O1|Outcome|Presatovir|Single dose of presatovir 200 mg (4 x 50 mg tablets)
71089|NCT02135614|E2|Reported Event|Placebo|Single dose of placebo tablets
71090|NCT02135614|E1|Reported Event|Presatovir|Single dose of presatovir 200 mg (4 x 50 mg tablets)
71091|NCT02135445|B3|Baseline|Total|Total of all reporting groups
71092|NCT02135445|B2|Baseline|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
71093|NCT02135445|B1|Baseline|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
71094|NCT02135445|P2|Participant Flow|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
71095|NCT02135445|P1|Participant Flow|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
71096|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
71097|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
71098|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
71099|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
71100|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
71101|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
71102|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
71103|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
71104|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
71105|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
71106|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
71107|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
71108|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
71109|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
71110|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
71244|NCT02135016|B3|Baseline|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
71111|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
71112|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
71113|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
71114|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
71115|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
71116|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
71117|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
71118|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
71119|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
71120|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
71121|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
71122|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
71123|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
71124|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
71125|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
71126|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
71127|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
71128|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
71129|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
71130|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
71131|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
71132|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
71133|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
71134|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
71135|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
71136|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
71137|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
71138|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
71139|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
71140|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
71141|NCT02135445|E2|Reported Event|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
71142|NCT02135445|E1|Reported Event|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
71143|NCT02135432|B3|Baseline|Total|Total of all reporting groups
71144|NCT02135432|B2|Baseline|Placebo|"matching placebo~Placebo"
71145|NCT02135432|B1|Baseline|Ivacaftor (VX-770)|"twice a day administration of Ivacaftor: 150mg~Ivacaftor"
71146|NCT02135432|P2|Participant Flow|Placebo|"matching placebo~Placebo"
71147|NCT02135432|P1|Participant Flow|Ivacaftor (VX-770)|"twice a day administration of Ivacaftor: 150mg~Ivacaftor"
71148|NCT02135432|O2|Outcome|Placebo|"matching placebo~Placebo"
71149|NCT02135432|O1|Outcome|Ivacaftor (VX-770)|"twice a day administration of Ivacaftor: 150mg~Ivacaftor"
71150|NCT02135432|O2|Outcome|Placebo|"matching placebo~Placebo"
71151|NCT02135432|O1|Outcome|Ivacaftor (VX-770)|"twice a day administration of Ivacaftor: 150mg~Ivacaftor"
71152|NCT02135432|O2|Outcome|Placebo|"matching placebo~Placebo"
71153|NCT02135432|O1|Outcome|Ivacaftor|patients randomized to ivacaftor twice daily
71154|NCT02135432|O2|Outcome|Placebo|"matching placebo~Placebo"
71155|NCT02135432|O1|Outcome|Ivacaftor (VX-770)|"twice a day administration of Ivacaftor: 150mg~Ivacaftor"
71156|NCT02135432|E2|Reported Event|Placebo|"matching placebo~Placebo"
71157|NCT02135432|E1|Reported Event|Ivacaftor (VX-770)|"twice a day administration of Ivacaftor: 150mg~Ivacaftor"
71158|NCT02135029|B4|Baseline|Total|Total of all reporting groups
71159|NCT02135029|B3|Baseline|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71160|NCT02135029|B2|Baseline|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71161|NCT02135029|B1|Baseline|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71162|NCT02135029|P3|Participant Flow|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71163|NCT02135029|P2|Participant Flow|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71164|NCT02135029|P1|Participant Flow|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71165|NCT02135029|O3|Outcome|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71166|NCT02135029|O2|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71167|NCT02135029|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71168|NCT02135029|O1|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71169|NCT02135029|O1|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71170|NCT02135029|O3|Outcome|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71171|NCT02135029|O2|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71172|NCT02135029|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71173|NCT02135029|O1|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71174|NCT02135029|O3|Outcome|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71175|NCT02135029|O2|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71176|NCT02135029|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71177|NCT02135029|O3|Outcome|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71178|NCT02135029|O2|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71179|NCT02135029|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71180|NCT02135029|O3|Outcome|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71181|NCT02135029|O2|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71182|NCT02135029|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71183|NCT02135029|O3|Outcome|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71184|NCT02135029|O2|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71185|NCT02135029|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71186|NCT02135029|O3|Outcome|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71187|NCT02135029|O2|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71188|NCT02135029|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71189|NCT02135029|O3|Outcome|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71190|NCT02135029|O2|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71191|NCT02135029|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71192|NCT02135029|O3|Outcome|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71193|NCT02135029|O2|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71194|NCT02135029|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71195|NCT02135029|O3|Outcome|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71196|NCT02135029|O2|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71197|NCT02135029|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71198|NCT02135029|O3|Outcome|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71199|NCT02135029|O2|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71200|NCT02135029|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71201|NCT02135029|O3|Outcome|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71202|NCT02135029|O2|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71203|NCT02135029|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71204|NCT02135029|O3|Outcome|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71205|NCT02135029|O2|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71206|NCT02135029|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71207|NCT02135029|O3|Outcome|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71208|NCT02135029|O2|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71209|NCT02135029|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71210|NCT02135029|O3|Outcome|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71211|NCT02135029|O2|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71212|NCT02135029|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71213|NCT02135029|O3|Outcome|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71214|NCT02135029|O2|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71215|NCT02135029|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71216|NCT02135029|O3|Outcome|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71217|NCT02135029|O2|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71218|NCT02135029|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71219|NCT02135029|O3|Outcome|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71220|NCT02135029|O2|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71221|NCT02135029|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71222|NCT02135029|O3|Outcome|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71223|NCT02135029|O2|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71224|NCT02135029|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71225|NCT02135029|O3|Outcome|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71226|NCT02135029|O2|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71227|NCT02135029|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71228|NCT02135029|O3|Outcome|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71229|NCT02135029|O2|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71230|NCT02135029|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71231|NCT02135029|O3|Outcome|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71232|NCT02135029|O2|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71233|NCT02135029|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71234|NCT02135029|O3|Outcome|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71235|NCT02135029|O2|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71236|NCT02135029|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71237|NCT02135029|O3|Outcome|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71238|NCT02135029|O2|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71239|NCT02135029|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71240|NCT02135029|E3|Reported Event|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
71241|NCT02135029|E2|Reported Event|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71242|NCT02135029|E1|Reported Event|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
71249|NCT02135016|P1|Participant Flow|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
71250|NCT02135016|O3|Outcome|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
71251|NCT02135016|O2|Outcome|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
71252|NCT02135016|O1|Outcome|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
71253|NCT02135016|O3|Outcome|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
71254|NCT02135016|O2|Outcome|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
71255|NCT02135016|O1|Outcome|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
71256|NCT02135016|O3|Outcome|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
71257|NCT02135016|O2|Outcome|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
71258|NCT02135016|O1|Outcome|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
71259|NCT02135016|O3|Outcome|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
71260|NCT02135016|O2|Outcome|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
71261|NCT02135016|O1|Outcome|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
71262|NCT02135016|O3|Outcome|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
71263|NCT02135016|O2|Outcome|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
71264|NCT02135016|O1|Outcome|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
71265|NCT02135016|E3|Reported Event|Group C|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
71266|NCT02135016|E2|Reported Event|Group B|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
71267|NCT02135016|E1|Reported Event|Group A|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
71268|NCT02134977|B1|Baseline|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
71269|NCT02134977|P1|Participant Flow|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
71270|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
71271|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
71272|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
71273|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
71274|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
71275|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
71276|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
71277|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
71278|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
71279|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
71280|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
71281|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
71282|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
71283|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
71284|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
71285|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
71286|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
71287|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
71288|NCT02134977|E1|Reported Event|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
71289|NCT02134951|B3|Baseline|Total|Total of all reporting groups
71290|NCT02134951|B2|Baseline|Placebo|randomized to placebo
71291|NCT02134951|B1|Baseline|Ketamine|randomized to ketamine
76797|NCT02104804|O1|Outcome|Saxagliptin Plus Insulin|Saxagliptin 5 mg plus insulin
71292|NCT02134951|P2|Participant Flow|Placebo|"Placebo group will receive normal saline~Normal saline: Normal saline will be used for placebo in this group"
71293|NCT02134951|P1|Participant Flow|Ketamine|"IV infusion of ketamine 0.23mg/kg bolus over 1 minutes followed by 0.58 mg/kg/hr over 30 minutes then 0.29mg/kg/hr over 64 minutes~Ketamine: intravenous infusion of saline solution with ketamine"
71294|NCT02134951|O2|Outcome|Placebo|"Placebo group will receive normal saline~Normal saline: Normal saline will be used for placebo in this group"
71295|NCT02134951|O1|Outcome|Ketamine|"IV infusion of ketamine 0.23mg/kg bolus over 1 minutes followed by 0.58 mg/kg/hr over 30 minutes then 0.29mg/kg/hr over 64 minutes~Ketamine: intravenous infusion of saline solution with ketamine"
71296|NCT02134951|O2|Outcome|Placebo|"Placebo group will receive normal saline~Normal saline: Normal saline will be used for placebo in this group"
71297|NCT02134951|O1|Outcome|Ketamine|"IV infusion of ketamine 0.23mg/kg bolus over 1 minutes followed by 0.58 mg/kg/hr over 30 minutes then 0.29mg/kg/hr over 64 minutes~Ketamine: intravenous infusion of saline solution with ketamine"
71298|NCT02134951|E2|Reported Event|Placebo|
71299|NCT02134951|E1|Reported Event|Ketamine|
71300|NCT02134925|B3|Baseline|Total|Total of all reporting groups
71301|NCT02134925|B2|Baseline|Arm II (Placebo)|Participants receive identical-appearing placebo injection in weeks 0, 2, and 10 and a booster injection in week 53.
71302|NCT02134925|B1|Baseline|Arm I (MUC1 Peptide-poly-ILCLC Adjuvant Vaccine)|Participants receive 300 microliters of MUC1 peptide vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53.
71303|NCT02134925|P2|Participant Flow|Arm II (Placebo)|Participants receive identical-appearing placebo injection in weeks 0, 2, and 10 and a booster injection in week 53.
71304|NCT02134925|P1|Participant Flow|Arm I (MUC1 Peptide-poly-ILCLC Adjuvant Vaccine)|Participants receive 300 microliters of MUC1 peptide vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53.
71305|NCT02134925|O2|Outcome|Arm II (Placebo)|Participants receive identical-appearing placebo injection in weeks 0, 2, and 10 and a booster injection in week 53.
71306|NCT02134925|O1|Outcome|Arm I (MUC1 Peptide-poly-ILCLC Adjuvant Vaccine)|Participants receive 300 microliters of MUC1 peptide vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53.
71307|NCT02134925|O2|Outcome|Arm II (Placebo)|Participants receive identical-appearing placebo injection in weeks 0, 2, and 10 and a booster injection in week 53.
71308|NCT02134925|O1|Outcome|Arm I (MUC1 Peptide-poly-ILCLC Adjuvant Vaccine)|Participants receive 300 microliters of MUC1 peptide vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53.
71309|NCT02134925|E2|Reported Event|Arm II (Placebo)|Participants receive identical-appearing placebo injection in weeks 0, 2, and 10 and a booster injection in week 53.
71310|NCT02134925|E1|Reported Event|Arm I (MUC1 Peptide-poly-ILCLC Adjuvant Vaccine)|Participants receive 300 microliters of MUC1 peptide vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53.
71311|NCT02134717|B1|Baseline|Sarcoidosis Stage II|"All subjects with active stage II sarcoidosis with or without skin disease will receive the drug maraviroc 300mg to be taken orally twice a day for 6 weeks duration.~all subjects will receive maraviroc 300mg orally twice a day for 6 weeks~Bronchoscopy with bronchoalveolar lavage: Bronchoscopy employs a flexible instrument that is inserted into the trachea and proximal airways after topical anesthesia. Bronchoalveolar lavage involves the instillation of saline solution through the bronchoscope into the airways followed by recovery under suction to collects lung fluid containing cells and proteins.~venipunctures: Venipunctures will be performed at study entry, after two weeks, and at the end of the study to collect blood for research studies and safety laboratories.~Skin biopsy: For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies."
71312|NCT02134717|P1|Participant Flow|Sarcoidosis Stage II|"All subjects with active stage II sarcoidosis with or without skin disease will receive the drug maraviroc 300mg to be taken orally twice a day for 6 weeks duration.~all subjects will receive maraviroc 300mg orally twice a day for 6 weeks~Bronchoscopy with bronchoalveolar lavage: Bronchoscopy employs a flexible instrument that is inserted into the trachea and proximal airways after topical anesthesia. Bronchoalveolar lavage involves the instillation of saline solution through the bronchoscope into the airways followed by recovery under suction to collects lung fluid containing cells and proteins.~venipunctures: Venipunctures will be performed at study entry, after two weeks, and at the end of the study to collect blood for research studies and safety laboratories.~Skin biopsy: For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies."
71313|NCT02134717|O1|Outcome|Sarcoidosis Stage II|"All subjects with active stage II sarcoidosis with or without skin disease will receive the drug maraviroc 300mg to be taken orally twice a day for 6 weeks duration.~all subjects will receive maraviroc 300mg orally twice a day for 6 weeks~Bronchoscopy with bronchoalveolar lavage: Bronchoscopy employs a flexible instrument that is inserted into the trachea and proximal airways after topical anesthesia. Bronchoalveolar lavage involves the instillation of saline solution through the bronchoscope into the airways followed by recovery under suction to collects lung fluid containing cells and proteins.~venipunctures: Venipunctures will be performed at study entry, after two weeks, and at the end of the study to collect blood for research studies and safety laboratories.~Skin biopsy: For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies."
71314|NCT02134717|O1|Outcome|Sarcoidosis Stage II|"All subjects with active stage II sarcoidosis with or without skin disease will receive the drug maraviroc 300mg to be taken orally twice a day for 6 weeks duration.~all subjects will receive maraviroc 300mg orally twice a day for 6 weeks~Bronchoscopy with bronchoalveolar lavage: Bronchoscopy employs a flexible instrument that is inserted into the trachea and proximal airways after topical anesthesia. Bronchoalveolar lavage involves the instillation of saline solution through the bronchoscope into the airways followed by recovery under suction to collects lung fluid containing cells and proteins.~venipunctures: Venipunctures will be performed at study entry, after two weeks, and at the end of the study to collect blood for research studies and safety laboratories.~Skin biopsy: For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies."
71333|NCT02134184|O3|Outcome|Recent CMV Converters|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
71334|NCT02134184|O2|Outcome|CMV Positive Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
71315|NCT02134717|O1|Outcome|Sarcoidosis Stage II|"All subjects with active stage II sarcoidosis with or without skin disease will receive the drug maraviroc 300mg to be taken orally twice a day for 6 weeks duration.~all subjects will receive maraviroc 300mg orally twice a day for 6 weeks~Bronchoscopy with bronchoalveolar lavage: Bronchoscopy employs a flexible instrument that is inserted into the trachea and proximal airways after topical anesthesia. Bronchoalveolar lavage involves the instillation of saline solution through the bronchoscope into the airways followed by recovery under suction to collects lung fluid containing cells and proteins.~venipunctures: Venipunctures will be performed at study entry, after two weeks, and at the end of the study to collect blood for research studies and safety laboratories.~Skin biopsy: For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies."
71316|NCT02134717|E1|Reported Event|Sarcoidosis Stage II|"All subjects with active stage II sarcoidosis with or without skin disease will receive the drug maraviroc 300mg to be taken orally twice a day for 6 weeks duration.~all subjects will receive maraviroc 300mg orally twice a day for 6 weeks~Bronchoscopy with bronchoalveolar lavage: Bronchoscopy employs a flexible instrument that is inserted into the trachea and proximal airways after topical anesthesia. Bronchoalveolar lavage involves the instillation of saline solution through the bronchoscope into the airways followed by recovery under suction to collects lung fluid containing cells and proteins.~venipunctures: Venipunctures will be performed at study entry, after two weeks, and at the end of the study to collect blood for research studies and safety laboratories.~Skin biopsy: For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies."
71317|NCT02134587|B1|Baseline|Subjects Post Educational Intervention|"Multifaceted educational intervention in pharmacovigilance~Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.~2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
71318|NCT02134587|P1|Participant Flow|Subjects Post Educational Intervention|"Multifaceted educational intervention in pharmacovigilance~Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.~2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
71319|NCT02134587|O2|Outcome|Subjects Prior to Educational Intervention|Skills of health professionals in fill correctly the adverse drug events form before educational intervention
71320|NCT02134587|O1|Outcome|Subjects Post Educational Intervention|"Skills of health professionals in fill correctly the adverse drug events form after multifaceted educational intervention in pharmacovigilance~Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.~2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
71321|NCT02134587|O2|Outcome|Subjects Prior to Educational Intervention|Knowledge of health professionals before the educational intervention regarding pharmacovigilance
71322|NCT02134587|O1|Outcome|Subjects Post Educational Intervention|"Knowledge of health professionals after multifaceted educational intervention in pharmacovigilance~Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.~2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
71323|NCT02134587|O2|Outcome|Subjects Prior to Educational Intervention|Number of health professionals who had the potential to report adverse drug reaction, before the educational intervention
71324|NCT02134587|O1|Outcome|Subjects Post Educational Intervention|"Multifaceted educational intervention in pharmacovigilance~Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.~2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
71325|NCT02134587|E1|Reported Event|Subjects Post Educational Intervention|"Multifaceted educational intervention in pharmacovigilance~Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.~2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
71326|NCT02134184|B4|Baseline|Total|Total of all reporting groups
71327|NCT02134184|B3|Baseline|Recent CMV Converters|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly"
71328|NCT02134184|B2|Baseline|CMV Positive Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly"
71329|NCT02134184|B1|Baseline|CMV Negative Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly"
71330|NCT02134184|P3|Participant Flow|Recent CMV Converters|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly Recent CMV Conversion is defined as: Donor has donated at least once within the recent timeframe (past three years) AND donor's most recent two donations tested CMV antibody positive AND donor had at least two CMV negative donations in the past"
71331|NCT02134184|P2|Participant Flow|CMV Positive Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
71332|NCT02134184|P1|Participant Flow|CMV Negative Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
71335|NCT02134184|O1|Outcome|CMV Negative Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
71336|NCT02134184|O3|Outcome|Recent CMV Converters|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
71337|NCT02134184|O2|Outcome|CMV Positive Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
71338|NCT02134184|O1|Outcome|CMV Negative Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
71339|NCT02134184|E3|Reported Event|Recent CMV Converters|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
71340|NCT02134184|E2|Reported Event|CMV Positive Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
71341|NCT02134184|E1|Reported Event|CMV Negative Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
71342|NCT02134119|B3|Baseline|Total|Total of all reporting groups
71343|NCT02134119|B2|Baseline|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
71344|NCT02134119|B1|Baseline|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
71345|NCT02134119|P2|Participant Flow|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
71346|NCT02134119|P1|Participant Flow|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
71347|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
71348|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
71349|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
71350|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
71351|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
71352|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
71353|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
71354|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
71355|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
71356|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
71357|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
71358|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
71359|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
71360|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
71361|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
71362|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
71363|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
71364|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
71365|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
71366|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
71367|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
71368|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
71369|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
71370|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
71371|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
71372|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
71373|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
71374|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
71375|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
71376|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
71377|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
71378|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
71379|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
71380|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
71381|NCT02134119|E2|Reported Event|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
71382|NCT02134119|E1|Reported Event|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
71383|NCT02134015|B3|Baseline|Total|Total of all reporting groups
71384|NCT02134015|B2|Baseline|Patritumab + Erlotinib|Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
71385|NCT02134015|B1|Baseline|Placebo + Erlotinib|Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
71386|NCT02134015|P2|Participant Flow|Patritumab + Erlotinib|Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
71387|NCT02134015|P1|Participant Flow|Placebo + Erlotinib|Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
71388|NCT02134015|O2|Outcome|Patritumab + Erlotinib|Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
71389|NCT02134015|O1|Outcome|Placebo + Erlotinib|Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
71390|NCT02134015|O2|Outcome|Patritumab + Erlotinib|Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
71391|NCT02134015|O1|Outcome|Placebo + Erlotinib|Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
71392|NCT02134015|O2|Outcome|Patritumab + Erlotinib|Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
71393|NCT02134015|O1|Outcome|Placebo + Erlotinib|Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
71394|NCT02134015|O2|Outcome|Patritumab + Erlotinib|Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
71395|NCT02134015|O1|Outcome|Placebo + Erlotinib|Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
71396|NCT02134015|O2|Outcome|Patritumab + Erlotinib|Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
71397|NCT02134015|O1|Outcome|Placebo + Erlotinib|Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
71398|NCT02134015|O2|Outcome|Patritumab + Erlotinib|Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
71399|NCT02134015|O1|Outcome|Placebo + Erlotinib|Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
71400|NCT02134015|O2|Outcome|Patritumab + Erlotinib|Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
71401|NCT02134015|O1|Outcome|Placebo + Erlotinib|Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
71402|NCT02134015|O2|Outcome|Patritumab + Erlotinib|Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
71403|NCT02134015|O1|Outcome|Placebo + Erlotinib|Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
71404|NCT02134015|E2|Reported Event|Patritumab + Erlotinib|Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
71405|NCT02134015|E1|Reported Event|Placebo + Erlotinib|Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
71406|NCT02133781|B4|Baseline|Total|Total of all reporting groups
71407|NCT02133781|B3|Baseline|Age > 70 Years (Non-twins)|"Participants will receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
71408|NCT02133781|B2|Baseline|Age 18-30 Years (Non-twins)|"Participants will be receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
71409|NCT02133781|B1|Baseline|Age 8-17 Years (Identical Twins )|"Participants will be randomized to receive either Fluzone® 2009-2010 Formula or Flumist® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly~Flumist® 2009-2010 Formula: This vaccine is given intranasally"
71410|NCT02133781|P3|Participant Flow|Age > 70 Years (Non-twins)|"Participants will receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
71411|NCT02133781|P2|Participant Flow|Age 18-30 Years (Non-twins)|"Participants will be receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
71412|NCT02133781|P1|Participant Flow|Age 8-17 Years (Identical Twins )|"Participants will be randomized to receive either Fluzone® 2009-2010 Formula or Flumist® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly~Flumist® 2009-2010 Formula: This vaccine is given intranasally"
71413|NCT02133781|O3|Outcome|Age > 70 Years (Non-twins)|"Participants will receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
71414|NCT02133781|O2|Outcome|Age 18-30 Years (Non-twins)|"Participants will be receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
71415|NCT02133781|O1|Outcome|Age 8-17 Years (Identical Twins )|"Participants will be randomized to receive either Fluzone® 2009-2010 Formula or Flumist® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly~Flumist® 2009-2010 Formula: This vaccine is given intranasally"
71416|NCT02133781|O3|Outcome|Age > 70 Years (Non-twins)|"Participants will receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
71417|NCT02133781|O2|Outcome|Age 18-30 Years (Non-twins)|"Participants will be receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
71418|NCT02133781|O1|Outcome|Age 8-17 Years (Identical Twins )|"Participants will be randomized to receive either Fluzone® 2009-2010 Formula or Flumist® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly~Flumist® 2009-2010 Formula: This vaccine is given intranasally"
71419|NCT02133781|E3|Reported Event|Age > 70 Years (Non-twins)|"Participants will receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
71420|NCT02133781|E2|Reported Event|Age 18-30 Years (Non-twins)|"Participants will be receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
71421|NCT02133781|E1|Reported Event|Age 8-17 Years (Identical Twins )|"Participants will be randomized to receive either Fluzone® 2009-2010 Formula or Flumist® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly~Flumist® 2009-2010 Formula: This vaccine is given intranasally"
71422|NCT02133664|B3|Baseline|Total|Total of all reporting groups
71423|NCT02133664|B2|Baseline|Placebo|"placebo oil and placebo lipoic acid~Placebo: placebo lipoic acid and placebo oil"
71424|NCT02133664|B1|Baseline|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and omega-3 fatty acids~Alpha lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid"
71425|NCT02133664|P2|Participant Flow|Placebo|"placebo oil and placebo lipoic acid~Placebo: placebo lipoic acid and placebo oil"
71426|NCT02133664|P1|Participant Flow|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and omega-3 fatty acids~lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid"
71427|NCT02133664|O2|Outcome|Placebo|"placebo oil and placebo lipoic acid~Placebo: placebo lipoic acid and placebo oil"
71428|NCT02133664|O1|Outcome|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and omega-3 fatty acids~lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid"
71429|NCT02133664|O2|Outcome|Placebo|"placebo oil and placebo lipoic acid~Placebo: placebo lipoic acid and placebo oil"
71430|NCT02133664|O1|Outcome|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and omega-3 fatty acids~lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid"
71431|NCT02133664|O2|Outcome|Placebo|"placebo oil and placebo lipoic acid~Placebo: placebo lipoic acid and placebo oil"
71432|NCT02133664|O1|Outcome|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and omega-3 fatty acids~lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid"
71433|NCT02133664|O2|Outcome|Placebo|"placebo oil and placebo lipoic acid~Placebo: placebo lipoic acid and placebo oil"
71434|NCT02133664|O1|Outcome|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and omega-3 fatty acids~lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid"
71435|NCT02133664|E2|Reported Event|Placebo|"placebo oil and placebo lipoic acid~Placebo: placebo lipoic acid and placebo oil"
71436|NCT02133664|E1|Reported Event|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and omega-3 fatty acids~Alpha lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid"
71437|NCT02133534|B1|Baseline|Atorvastatin|"Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging.~Atorvastatin"
71438|NCT02133534|P1|Participant Flow|Atorvastatin|"Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging.~Atorvastatin"
71439|NCT02133534|O1|Outcome|Atorvastatin|"Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging.~Atorvastatin"
71497|NCT02133131|O5|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
76798|NCT02104804|O2|Outcome|Vs. Placebo Plus Insulin|Patients receiving placebo 5 mg plus insulin
71440|NCT02133534|E1|Reported Event|Atorvastatin|"Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging.~Atorvastatin"
71441|NCT02133508|B1|Baseline|NSCLC Participants|Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy.
71442|NCT02133508|P1|Participant Flow|NSCLC Participants|Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy.
71443|NCT02133508|O1|Outcome|NSCLC Participants|Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy.
71444|NCT02133508|O1|Outcome|NSCLC Participants|Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy.
71445|NCT02133508|O1|Outcome|NSCLC Participants|Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy.
71446|NCT02133508|O1|Outcome|NSCLC Participants|Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy.
71447|NCT02133508|O1|Outcome|NSCLC Participants|Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy.
71448|NCT02133508|E1|Reported Event|NSCLC Participants|Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy.
71449|NCT02133352|B1|Baseline|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.~Ranolazine: Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
71450|NCT02133352|P1|Participant Flow|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.~Ranolazine: open label/Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
71451|NCT02133352|O1|Outcome|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.~Ranolazine: open label/Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
71452|NCT02133352|O1|Outcome|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.~Ranolazine: open label/Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
71453|NCT02133352|O1|Outcome|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.~Ranolazine: open label/Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
71454|NCT02133352|O1|Outcome|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.~Ranolazine: open label/Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
71455|NCT02133352|O1|Outcome|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.~Ranolazine: open label/Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
71456|NCT02133352|O1|Outcome|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.~Ranolazine: open label/Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
71457|NCT02133352|E1|Reported Event|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.~Ranolazine: Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
71458|NCT02133235|B3|Baseline|Total|Total of all reporting groups
71459|NCT02133235|B2|Baseline|Conventional Fiberoptic Brochoscopy Group|patients receiving VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
71460|NCT02133235|B1|Baseline|Auscultation Group|patients receiving vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
71461|NCT02133235|P2|Participant Flow|Auscultation Group|patients receiving vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
71462|NCT02133235|P1|Participant Flow|Conventional Fiberoptic Brochoscopy Group|patients receiving VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
71463|NCT02133235|O4|Outcome|Right-sided VATS, Conventional Fiberoptic Bronchoscopy Group|patients receiving right-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
71464|NCT02133235|O3|Outcome|Right-sided VATS, Auscultation Group|patients receiving right-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
71465|NCT02133235|O2|Outcome|Left-sided VATS, Conventional Fiberoptic Brochoscopy Group|patients receiving left-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
71466|NCT02133235|O1|Outcome|Left-sided VATS, Auscultation Group|patients receiving left-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
71467|NCT02133235|O4|Outcome|Right-sided VATS, Conventional Fiberoptic Bronchoscopy Group|patients receiving right-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by conventional fiberoptic brochoscopy group
71468|NCT02133235|O3|Outcome|Right-sided VATS, Auscultation Group|patients receiving right-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by auscultation only
71469|NCT02133235|O2|Outcome|Left-sided VATS, Conventional Fiberoptic Brochoscopy Group|patients receiving left-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by conventional fiberoptic brochoscopy group
71470|NCT02133235|O1|Outcome|Left-sided VATS, Auscultation Group|patients receiving left-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by auscultation only
71471|NCT02133235|E2|Reported Event|Auscultation Group|patients receiving vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
71472|NCT02133235|E1|Reported Event|Conventional Fiberoptic Brochoscopy Group|patients receiving VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
71473|NCT02133131|B8|Baseline|Total|Total of all reporting groups
71474|NCT02133131|B7|Baseline|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
71475|NCT02133131|B6|Baseline|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
71476|NCT02133131|B5|Baseline|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
71477|NCT02133131|B4|Baseline|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
71478|NCT02133131|B3|Baseline|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
71479|NCT02133131|B2|Baseline|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
71480|NCT02133131|B1|Baseline|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
71481|NCT02133131|P7|Participant Flow|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
71482|NCT02133131|P6|Participant Flow|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
71483|NCT02133131|P5|Participant Flow|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
71484|NCT02133131|P4|Participant Flow|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
71485|NCT02133131|P3|Participant Flow|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
71486|NCT02133131|P2|Participant Flow|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
71487|NCT02133131|P1|Participant Flow|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
71488|NCT02133131|O7|Outcome|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
71489|NCT02133131|O6|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
71490|NCT02133131|O5|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
71491|NCT02133131|O4|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
71492|NCT02133131|O3|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
71493|NCT02133131|O2|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
71494|NCT02133131|O1|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
71495|NCT02133131|O7|Outcome|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
71496|NCT02133131|O6|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
71498|NCT02133131|O4|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
71499|NCT02133131|O3|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
71500|NCT02133131|O2|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
71501|NCT02133131|O1|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
71502|NCT02133131|O7|Outcome|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
71503|NCT02133131|O6|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
71504|NCT02133131|O5|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
71505|NCT02133131|O4|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
71506|NCT02133131|O3|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
71507|NCT02133131|O2|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
71508|NCT02133131|O1|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
71509|NCT02133131|O7|Outcome|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
71510|NCT02133131|O6|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
71511|NCT02133131|O5|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
71512|NCT02133131|O4|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
71513|NCT02133131|O3|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
71514|NCT02133131|O2|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
71515|NCT02133131|O1|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
71516|NCT02133131|E7|Reported Event|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
71517|NCT02133131|E6|Reported Event|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
71518|NCT02133131|E5|Reported Event|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
71519|NCT02133131|E4|Reported Event|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
71520|NCT02133131|E3|Reported Event|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
71521|NCT02133131|E2|Reported Event|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
71522|NCT02133131|E1|Reported Event|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
71523|NCT02133066|B3|Baseline|Total|Total of all reporting groups
71524|NCT02133066|B2|Baseline|Routine Lumbar Puncture|"These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a standard-of-care spinal tap performed by the clinician~Routine lumbar puncture: Lumbar puncture will be performed per routine standard of care"
71525|NCT02133066|B1|Baseline|US-Assisted Site Marking for LP|"Mindray M7 Ultrasound marking~Bedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.~Mindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap"
71526|NCT02133066|P2|Participant Flow|Routine Lumbar Puncture|"These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a standard-of-care spinal tap performed by the clinician~Routine lumbar puncture: Lumbar puncture will be performed per routine standard of care"
71527|NCT02133066|P1|Participant Flow|US-Assisted Site Marking for LP|"Mindray M7 Ultrasound marking~Bedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.~Mindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap"
71528|NCT02133066|O2|Outcome|Routine Lumbar Puncture|"These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a standard-of-care spinal tap performed by the clinician~Routine lumbar puncture: Lumbar puncture will be performed per routine standard of care"
71529|NCT02133066|O1|Outcome|US-Assisted Site Marking for LP|"Mindray M7 Ultrasound marking~Bedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.~Mindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap"
71530|NCT02133066|O2|Outcome|Routine Lumbar Puncture|"These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a standard-of-care spinal tap performed by the clinician~Routine lumbar puncture: Lumbar puncture will be performed per routine standard of care"
71531|NCT02133066|O1|Outcome|US-Assisted Site Marking for LP|"Mindray M7 Ultrasound marking~Bedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.~Mindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap"
71532|NCT02133066|O2|Outcome|Routine Lumbar Puncture|"These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a standard-of-care spinal tap performed by the clinician~Routine lumbar puncture: Lumbar puncture will be performed per routine standard of care"
71533|NCT02133066|O1|Outcome|US-Assisted Site Marking for LP|"Mindray M7 Ultrasound marking~Bedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.~Mindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap"
71534|NCT02133066|O2|Outcome|Routine Lumbar Puncture|"These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a standard-of-care spinal tap performed by the clinician~Routine lumbar puncture: Lumbar puncture will be performed per routine standard of care"
71535|NCT02133066|O1|Outcome|US-Assisted Site Marking for LP|"Mindray M7 Ultrasound marking~Bedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.~Mindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap"
71536|NCT02133066|E2|Reported Event|Routine Lumbar Puncture|"These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a standard-of-care spinal tap performed by the clinician~Routine lumbar puncture: Lumbar puncture will be performed per routine standard of care"
71537|NCT02133066|E1|Reported Event|US-Assisted Site Marking for LP|"Mindray M7 Ultrasound marking~Bedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.~Mindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap"
71538|NCT02132949|B3|Baseline|Total|Total of all reporting groups
71539|NCT02132949|B2|Baseline|Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71540|NCT02132949|B1|Baseline|Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 milligrams per square meter (mg/m^2; as an intravenous [IV] bolus over 3-5 minutes [min] or as an infusion over 15-30min) once in every 2 weeks (q2w) and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion once weekly (qw) for 12 weeks. Pertuzumab 840 milligrams (mg) loading dose IV, then 420mg IV q3w and trastuzumab 8 milligrams per kilogram (mg/kg) loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71541|NCT02132949|P2|Participant Flow|Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71542|NCT02132949|P1|Participant Flow|Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 milligrams per square meter (mg/m^2; as an intravenous [IV] bolus over 3-5 minutes [min] or as an infusion over 15-30min) once in every 2 weeks (q2w) and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion once weekly (qw) for 12 weeks. Pertuzumab 840 milligrams (mg) loading dose IV, then 420mg IV q3w and trastuzumab 8 milligrams per kilogram (mg/kg) loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71595|NCT02132884|P2|Participant Flow|Arm B (Genetic Sequencing and Targeted Therapy)|"Patients undergo collection of tissue and blood samples for analysis via sequencing. Upon disease progression following front-line treatment, patients receive specific targeted therapy based on the mutational status obtained during sequencing.~cytology specimen collection procedure: Undergo collection of tissue and blood samples~targeted therapy: Receive specific targeted therapy~laboratory biomarker analysis: Correlative studies"
71736|NCT02132117|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
71543|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71544|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71545|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71546|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71547|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71548|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71549|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71550|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71596|NCT02132884|P1|Participant Flow|Arm A (Standard of Care Treatment)|"Patients receive standard of care treatment based on the discretion of the treating physician.~therapeutic procedure: Receive standard of care treatment~laboratory biomarker analysis: Correlative studies"
71737|NCT02132117|O2|Outcome|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
71551|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71552|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71553|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71554|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71555|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71556|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71557|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71558|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71630|NCT02132832|E2|Reported Event|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
71631|NCT02132832|E1|Reported Event|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
71559|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71560|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71561|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71562|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71563|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71564|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71565|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71566|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71632|NCT02132767|B3|Baseline|Total|Total of all reporting groups
71662|NCT02132637|O2|Outcome|Insulin Glargine|Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.
71567|NCT02132949|E2|Reported Event|Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71568|NCT02132949|E1|Reported Event|Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 milligrams per square meter (mg/m^2; as an intravenous [IV] bolus over 3-5 minutes [min] or as an infusion over 15-30min) once in every 2 weeks (q2w) and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion once weekly (qw) for 12 weeks. Pertuzumab 840 milligrams (mg) loading dose IV, then 420mg IV q3w and trastuzumab 8 milligrams per kilogram (mg/kg) loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
71569|NCT02132936|B5|Baseline|Total|Total of all reporting groups
71570|NCT02132936|B4|Baseline|Gel Vehicle|"Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks~Gel vehicle"
71571|NCT02132936|B3|Baseline|Calcipotriol BDP Gel|"Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks~Calcipotriol BDP gel"
71572|NCT02132936|B2|Baseline|Aerosol Foam Vehicle|"Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks~Aerosol foam vehicle"
71573|NCT02132936|B1|Baseline|LEO 90100|"LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks~LEO 90100 aerosol foam"
71574|NCT02132936|P4|Participant Flow|Gel Vehicle|Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks
71575|NCT02132936|P3|Participant Flow|Calcipotriol BDP Gel|Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
71576|NCT02132936|P2|Participant Flow|Aerosol Foam Vehicle|Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks
71577|NCT02132936|P1|Participant Flow|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
71578|NCT02132936|O2|Outcome|Calcipotriol BDP Gel|Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
71579|NCT02132936|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
71580|NCT02132936|O2|Outcome|Aerosol Foam Vehicle|"Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks~Aerosol foam vehicle"
71581|NCT02132936|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
71582|NCT02132936|O2|Outcome|Calcipotriol BDP Gel|Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
71583|NCT02132936|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
71584|NCT02132936|O2|Outcome|Calcipotriol BDP Gel|"Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks~Calcipotriol BDP gel"
71585|NCT02132936|O1|Outcome|LEO 90100|"LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks~LEO 90100 aerosol foam"
71586|NCT02132936|O2|Outcome|Calcipotriol BDP Gel|Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
71587|NCT02132936|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
71588|NCT02132936|E4|Reported Event|Gel Vehicle|"Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks~Gel vehicle"
71589|NCT02132936|E3|Reported Event|Calcipotriol BDP Gel|"Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks~Calcipotriol BDP gel"
71590|NCT02132936|E2|Reported Event|Aerosol Foam Vehicle|"Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks~Aerosol foam vehicle"
71591|NCT02132936|E1|Reported Event|LEO 90100|"LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks~LEO 90100 aerosol foam"
71592|NCT02132884|B3|Baseline|Total|Total of all reporting groups
71593|NCT02132884|B2|Baseline|Arm B (Genetic Sequencing and Targeted Therapy)|"Patients undergo collection of tissue and blood samples for analysis via sequencing. Upon disease progression following front-line treatment, patients receive specific targeted therapy based on the mutational status obtained during sequencing.~cytology specimen collection procedure: Undergo collection of tissue and blood samples~targeted therapy: Receive specific targeted therapy~laboratory biomarker analysis: Correlative studies"
71594|NCT02132884|B1|Baseline|Arm A (Standard of Care Treatment)|"Patients receive standard of care treatment based on the discretion of the treating physician.~therapeutic procedure: Receive standard of care treatment~laboratory biomarker analysis: Correlative studies"
76799|NCT02104804|O1|Outcome|Saxagliptin Plus Insulin|Saxagliptin 5 mg plus insulin
71597|NCT02132884|O2|Outcome|Arm B (Genetic Sequencing and Targeted Therapy)|"Patients undergo collection of tissue and blood samples for analysis via sequencing. Upon disease progression following front-line treatment, patients receive specific targeted therapy based on the mutational status obtained during sequencing.~cytology specimen collection procedure: Undergo collection of tissue and blood samples~targeted therapy: Receive specific targeted therapy~laboratory biomarker analysis: Correlative studies"
71598|NCT02132884|O1|Outcome|Arm A (Standard of Care Treatment)|"Patients receive standard of care treatment based on the discretion of the treating physician.~therapeutic procedure: Receive standard of care treatment~laboratory biomarker analysis: Correlative studies"
71599|NCT02132884|E2|Reported Event|Arm B (Genetic Sequencing and Targeted Therapy)|"Patients undergo collection of tissue and blood samples for analysis via sequencing. Upon disease progression following front-line treatment, patients receive specific targeted therapy based on the mutational status obtained during sequencing.~cytology specimen collection procedure: Undergo collection of tissue and blood samples~targeted therapy: Receive specific targeted therapy~laboratory biomarker analysis: Correlative studies"
71600|NCT02132884|E1|Reported Event|Arm A (Standard of Care Treatment)|"Patients receive standard of care treatment based on the discretion of the treating physician.~therapeutic procedure: Receive standard of care treatment~laboratory biomarker analysis: Correlative studies"
71601|NCT02132832|B3|Baseline|Total|Total of all reporting groups
71602|NCT02132832|B2|Baseline|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
71603|NCT02132832|B1|Baseline|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
71604|NCT02132832|P2|Participant Flow|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
71605|NCT02132832|P1|Participant Flow|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
71606|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
71607|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
71608|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
71609|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
71610|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
71611|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
71612|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
71613|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
71614|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
71615|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
71616|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
71617|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
71618|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
71619|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
71620|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
71621|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
71622|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
71623|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
71624|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
71625|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
71626|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
71627|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
71628|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
71629|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
71633|NCT02132767|B2|Baseline|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
71634|NCT02132767|B1|Baseline|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
71635|NCT02132767|P2|Participant Flow|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
71636|NCT02132767|P1|Participant Flow|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
71637|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
71638|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
71639|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
71640|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
71660|NCT02132637|O2|Outcome|Insulin Glargine|Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.
71641|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
71642|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
71643|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
71644|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
71645|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
71646|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
71647|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
71648|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
71661|NCT02132637|O1|Outcome|Insulin Peglispro|Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.
76800|NCT02104804|O2|Outcome|Vs. Placebo Plus Insulin|Patients receiving placebo 5 mg plus insulin
71649|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
71650|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
71651|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
71652|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
71653|NCT02132767|E2|Reported Event|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
71654|NCT02132767|E1|Reported Event|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
71655|NCT02132637|B3|Baseline|Total|Total of all reporting groups
71656|NCT02132637|B2|Baseline|Insulin Glargine/Insulin Peglispro|"Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in the first study period. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.~Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in the second study period. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay."
71657|NCT02132637|B1|Baseline|Insulin Peglispro/Insulin Glargine|"Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in the first study period. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.~Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in the second study period. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay."
71658|NCT02132637|P2|Participant Flow|Insulin Glargine/Insulin Peglispro|"Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in the first study period. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.~Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in the second study period. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay."
71659|NCT02132637|P1|Participant Flow|Insulin Peglispro/Insulin Glargine|"Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in the first study period. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.~Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in the second study period. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay."
71689|NCT02132572|O1|Outcome|Natrelle BIOCELL™ Textured 410 Implant|Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
71663|NCT02132637|O1|Outcome|Insulin Peglispro|Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.
71664|NCT02132637|O2|Outcome|Insulin Glargine|Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.
71665|NCT02132637|O1|Outcome|Insulin Peglispro|Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.
71666|NCT02132637|O2|Outcome|Insulin Glargine|Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.
71667|NCT02132637|O1|Outcome|Insulin Peglispro|Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.
71668|NCT02132637|O2|Outcome|Insulin Glargine|Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.
71669|NCT02132637|O1|Outcome|Insulin Peglispro|Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.
71670|NCT02132637|O2|Outcome|Insulin Glargine|Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.
71671|NCT02132637|O1|Outcome|Insulin Peglispro|Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.
71672|NCT02132637|O2|Outcome|Insulin Glargine|Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.
71673|NCT02132637|O1|Outcome|Insulin Peglispro|Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.
71674|NCT02132637|O2|Outcome|Insulin Glargine|Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.
71675|NCT02132637|O1|Outcome|Insulin Peglispro|Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.
71676|NCT02132637|O2|Outcome|Insulin Glargine|Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.
71677|NCT02132637|O1|Outcome|Insulin Peglispro|Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.
71678|NCT02132637|O2|Outcome|Insulin Glargine|Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.
71679|NCT02132637|O1|Outcome|Insulin Peglispro|Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.
71680|NCT02132637|E2|Reported Event|Insulin Glargine|Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.
71681|NCT02132637|E1|Reported Event|Insulin Peglispro|Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.
71682|NCT02132611|B1|Baseline|Diamondback 360® Coronary OAS Micro Crown|Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
71683|NCT02132611|P1|Participant Flow|Diamondback 360® Coronary OAS Micro Crown|Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
71684|NCT02132611|O1|Outcome|Diamondback 360® Coronary OAS Micro Crown|Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
71685|NCT02132611|O1|Outcome|Diamondback 360® Coronary OAS Micro Crown|Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
71686|NCT02132611|E1|Reported Event|Diamondback 360® Coronary OAS Micro Crown|Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
71687|NCT02132572|B1|Baseline|Natrelle BIOCELL™ Textured 410 Implant|Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
71688|NCT02132572|P1|Participant Flow|Natrelle BIOCELL™ Textured 410 Implant|Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
71690|NCT02132572|E1|Reported Event|Natrelle BIOCELL™ Textured 410 Implant|Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
71691|NCT02132468|B1|Baseline|Fosbretabulin Tromethamine|"Fosbretabulin 90 mg/vial; 60 mg/m2, IV infusion over 10 minutes; 1x/wk; three 3-week cycles~fosbretabulin tromethamine: 60 mg/m2, IV on Day 1, 8 and 15 of a 3-week cycle; 3 cycles or until progression or unacceptable toxicity"
71692|NCT02132468|P1|Participant Flow|Fosbretabulin Tromethamine|"Fosbretabulin 90 mg/vial; 60 mg/m2, IV infusion over 10 minutes; 1x/wk; three 3-week cycles~fosbretabulin tromethamine: 60 mg/m2, IV on Day 1, 8 and 15 of a 3-week cycle; 3 cycles or until progression or unacceptable toxicity"
71693|NCT02132468|O1|Outcome|Fosbretabulin Tromethamine|"Fosbretabulin 90 mg/vial; 60 mg/m2, IV infusion over 10 minutes; 1x/wk; three 3-week cycles~fosbretabulin tromethamine: 60 mg/m2, IV on Day 1, 8 and 15 of a 3-week cycle; 3 cycles or until progression or unacceptable toxicity"
71694|NCT02132468|O1|Outcome|Fosbretabulin Tromethamine|"Fosbretabulin 90 mg/vial; 60 mg/m2, IV infusion over 10 minutes; 1x/wk; three 3-week cycles~fosbretabulin tromethamine: 60 mg/m2, IV on Day 1, 8 and 15 of a 3-week cycle; 3 cycles or until progression or unacceptable toxicity"
71695|NCT02132468|O1|Outcome|Fosbretabulin Tromethamine|"Fosbretabulin 90 mg/vial; 60 mg/m2, IV infusion over 10 minutes; 1x/wk; three 3-week cycles~fosbretabulin tromethamine: 60 mg/m2, IV on Day 1, 8 and 15 of a 3-week cycle; 3 cycles or until progression or unacceptable toxicity"
71696|NCT02132468|O1|Outcome|Fosbretabulin Tromethamine|"Fosbretabulin 90 mg/vial; 60 mg/m2, IV infusion over 10 minutes; 1x/wk; three 3-week cycles~fosbretabulin tromethamine: 60 mg/m2, IV on Day 1, 8 and 15 of a 3-week cycle; 3 cycles or until progression or unacceptable toxicity"
71697|NCT02132468|E1|Reported Event|Fosbretabulin Tromethamine|"Fosbretabulin 90 mg/vial; 60 mg/m2, IV infusion over 10 minutes; 1x/wk; three 3-week cycles~fosbretabulin tromethamine: 60 mg/m2, IV on Day 1, 8 and 15 of a 3-week cycle; 3 cycles or until progression or unacceptable toxicity"
71698|NCT02132247|B3|Baseline|Total|Total of all reporting groups
71699|NCT02132247|B2|Baseline|Flector Patch/Age 12-16|12-16 year old participants treated with Flector Patch twice per day.
71700|NCT02132247|B1|Baseline|Flector Patch/Age 6-11|6-11 year old participants treated with Flector Patch twice per day.
71701|NCT02132247|P2|Participant Flow|Flector Patch/Age 12-16|Flector Patch is a topical delivery system containing 180 mg of diclofenac epolamine. The patch will be used twice-a-day for up to two weeks, or until pain resolution, whichever comes first.
71702|NCT02132247|P1|Participant Flow|Flector Patch/Age 6-11|Flector Patch is a topical delivery system containing 180 mg of diclofenac epolamine. The patch will be used twice-a-day for up to two weeks, or until pain resolution, whichever comes first.
71703|NCT02132247|O2|Outcome|Flector Patch/Age 12-16|12-16 year old participants treated with Flector Patch twice per day.
71704|NCT02132247|O1|Outcome|Flector Patch/Age 6-11|6-11 year old participants treated with Flector Patch twice per day.
71705|NCT02132247|O2|Outcome|Flector Patch/Age 12-16|12-16 year old participants treated with Flector Patch twice per day.
71706|NCT02132247|O1|Outcome|Flector Patch/Age 6-11|6-11 year old participants treated with Flector Patch twice per day.
71707|NCT02132247|O2|Outcome|Flector Patch/Age 12-16|12-16 year old participants treated with Flector Patch twice per day.
71708|NCT02132247|O1|Outcome|Flector Patch/Age 6-11|6-11 year old participants treated with Flector Patch twice per day.
71709|NCT02132247|O2|Outcome|Flector Patch/Age 12-16|12-16 year old participants treated with Flector Patch twice per day.
71710|NCT02132247|O1|Outcome|Flector Patch/Age 6-11|6-11 year old participants treated with Flector Patch twice per day.
71711|NCT02132247|E2|Reported Event|Flector Patch/Age 12-16|12-16 year old participants treated with Flector Patch twice per day.
71712|NCT02132247|E1|Reported Event|Flector Patch/Age 6-11|6-11 year old participants treated with Flector Patch twice per day.
71713|NCT02132169|B3|Baseline|Total|Total of all reporting groups
71714|NCT02132169|B2|Baseline|AC-170 0%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%
71715|NCT02132169|B1|Baseline|AC-170 0.24%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%
71716|NCT02132169|P2|Participant Flow|AC-170 0%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%
71717|NCT02132169|P1|Participant Flow|AC-170 0.24%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%
71718|NCT02132169|O2|Outcome|AC-170 0%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%
71719|NCT02132169|O1|Outcome|AC-170 0.24%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%
71720|NCT02132169|O2|Outcome|AC-170 0%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%
71721|NCT02132169|O1|Outcome|AC-170 0.24%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%
71722|NCT02132169|O2|Outcome|AC-170 0%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%
71723|NCT02132169|O1|Outcome|AC-170 0.24%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%
71724|NCT02132169|O2|Outcome|AC-170 0%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%
71725|NCT02132169|O1|Outcome|AC-170 0.24%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%
71726|NCT02132169|E2|Reported Event|AC-170 0%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%
71727|NCT02132169|E1|Reported Event|AC-170 0.24%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%
71728|NCT02132117|B3|Baseline|Total|Total of all reporting groups
71729|NCT02132117|B2|Baseline|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
71730|NCT02132117|B1|Baseline|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
71731|NCT02132117|P2|Participant Flow|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
71732|NCT02132117|P1|Participant Flow|Oxymetazoline HCL Cream 1.0%|Oxymetazoline hydrochloride (HCL) Cream 1.0% applied to the face once daily for 29 days.
71733|NCT02132117|O2|Outcome|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
71734|NCT02132117|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
71735|NCT02132117|O2|Outcome|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
71738|NCT02132117|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
71739|NCT02132117|O2|Outcome|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
71740|NCT02132117|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
71741|NCT02132117|O2|Outcome|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
71742|NCT02132117|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
71743|NCT02132117|O2|Outcome|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
71744|NCT02132117|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
71745|NCT02132117|E2|Reported Event|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
71746|NCT02132117|E1|Reported Event|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
71747|NCT02131662|B6|Baseline|Total|Total of all reporting groups
71748|NCT02131662|B5|Baseline|Placebo|Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71749|NCT02131662|B4|Baseline|VPR 0.5 mg|Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71750|NCT02131662|B3|Baseline|VPR 1 mg|Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71751|NCT02131662|B2|Baseline|VPR 2 mg|Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71752|NCT02131662|B1|Baseline|VPR 4 mg|Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71753|NCT02131662|P5|Participant Flow|Placebo|Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71754|NCT02131662|P4|Participant Flow|VPR 0.5 mg|Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71755|NCT02131662|P3|Participant Flow|VPR 1 mg|Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71756|NCT02131662|P2|Participant Flow|VPR 2 mg|Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71757|NCT02131662|P1|Participant Flow|VPR 4 mg|Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71758|NCT02131662|O1|Outcome|Full Analysis Set|FAS (N=300) included all subjects who took at least 1 dose of study drug.
71759|NCT02131662|O1|Outcome|Full Analysis Set|FAS (N=300) included all subjects who took at least 1 dose of study drug.
71760|NCT02131662|O1|Outcome|Full Analysis Set|FAS (N=300) included all subjects who took at least 1 dose of study drug.
71761|NCT02131662|O5|Outcome|Placebo|Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71762|NCT02131662|O4|Outcome|VPR 0.5 mg|Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71763|NCT02131662|O3|Outcome|VPR 1 mg|Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71764|NCT02131662|O2|Outcome|VPR 2 mg|Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71765|NCT02131662|O1|Outcome|VPR 4 mg|Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71766|NCT02131662|O5|Outcome|Placebo|Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71767|NCT02131662|O4|Outcome|VPR 0.5 mg|Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71768|NCT02131662|O3|Outcome|VPR 1 mg|Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71769|NCT02131662|O2|Outcome|VPR 2 mg|Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71770|NCT02131662|O1|Outcome|VPR 4 mg|Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71771|NCT02131662|O1|Outcome|Method Interchange Analysis Set|Method interchange analysis set (N=399) for the assessment of the interchangeability of the menstrual pictogram (MP) and the alkaline hematin (AH) method to judge menstrual blood loss (MBL) included subjects with sanitary product data for which there was a matching pair of MP score and AH value available.
71772|NCT02131662|O1|Outcome|Full Analysis Set|FAS (N=300) included all subjects who took at least 1 dose of study drug. Only subjects with valid data for this assessment were included.
71773|NCT02131662|O1|Outcome|Full Analysis Set|FAS (N=300) included all subjects who took at least 1 dose of study drug. Only subjects with valid data for this assessment were included
71774|NCT02131662|O1|Outcome|Full Analysis Set|FAS (N=300) included all subjects who took at least 1 dose of study drug. Only subjects with valid data for this assessment were included
71775|NCT02131662|O5|Outcome|Placebo|Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71776|NCT02131662|O4|Outcome|VPR 0.5 mg|Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71777|NCT02131662|O3|Outcome|VPR 1 mg|Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71778|NCT02131662|O2|Outcome|VPR 2 mg|Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71779|NCT02131662|O1|Outcome|VPR 4 mg|Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71780|NCT02131662|O5|Outcome|Placebo|Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71781|NCT02131662|O4|Outcome|VPR 0.5 mg|Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71782|NCT02131662|O3|Outcome|VPR 1 mg|Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71783|NCT02131662|O2|Outcome|VPR 2 mg|Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71784|NCT02131662|O1|Outcome|VPR 4 mg|Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71785|NCT02131662|O5|Outcome|Placebo|Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71786|NCT02131662|O4|Outcome|VPR 0.5 mg|Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71787|NCT02131662|O3|Outcome|VPR 1 mg|Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71788|NCT02131662|O2|Outcome|VPR 2 mg|Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71789|NCT02131662|O1|Outcome|VPR 4 mg|Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71790|NCT02131662|O5|Outcome|Placebo|Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71791|NCT02131662|O4|Outcome|VPR 0.5 mg|Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71792|NCT02131662|O3|Outcome|VPR 1 mg|Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71793|NCT02131662|O2|Outcome|VPR 2 mg|Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71794|NCT02131662|O1|Outcome|VPR 4 mg|Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71795|NCT02131662|E5|Reported Event|Placebo|Subjects matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71796|NCT02131662|E4|Reported Event|VPR 0.5 mg|Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71797|NCT02131662|E3|Reported Event|VPR 1 mg|Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71798|NCT02131662|E2|Reported Event|VPR 2 mg|Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71799|NCT02131662|E1|Reported Event|VPR 4 mg|Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
71800|NCT02131636|B3|Baseline|Total|Total of all reporting groups
71801|NCT02131636|B2|Baseline|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
71802|NCT02131636|B1|Baseline|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
71803|NCT02131636|P2|Participant Flow|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
71804|NCT02131636|P1|Participant Flow|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
71805|NCT02131636|O2|Outcome|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
71806|NCT02131636|O1|Outcome|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
71807|NCT02131636|O2|Outcome|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
71808|NCT02131636|O1|Outcome|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
71809|NCT02131636|O2|Outcome|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
71810|NCT02131636|O1|Outcome|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
71811|NCT02131636|O2|Outcome|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
71812|NCT02131636|O1|Outcome|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
71813|NCT02131636|O2|Outcome|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
71814|NCT02131636|O1|Outcome|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
71815|NCT02131636|O2|Outcome|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
71816|NCT02131636|O1|Outcome|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
71817|NCT02131636|E2|Reported Event|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
71818|NCT02131636|E1|Reported Event|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
71819|NCT02131532|B1|Baseline|Intervention Group|Baseline characteristics of eight participants who completed all treatment sessions
71820|NCT02131532|P1|Participant Flow|Psychological Intervention|All participants were enrolled in this group, receiving a psychological intervention for the treatment of post-stroke fatigue.
71821|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
71822|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
71823|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
71824|NCT02131532|O1|Outcome|Intervention Group|This outcome presents the recruitment process. However, only eight participants who completed all treatment sessions were included for further analysis of clinical outcomes.
71825|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
71826|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
71827|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
71828|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
71829|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
71830|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
71831|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
71832|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
71833|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
71834|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
71835|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
71836|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
71837|NCT02131532|E1|Reported Event|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
71838|NCT02131402|B1|Baseline|Enfilcon A / Omafilcon A/Ocufilcon D/Methafilcon A|"Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.~Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A) in the contra lateral eye. Test lens (enfilcon A) in one eye and a control lens (ocufilcon D) in the contralateral eye. Test lens (enfilcon A) in one eye and a control lens (methafilcon A) in the contra lateral eye."
71839|NCT02131402|P1|Participant Flow|Overall Participants Flow|"Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.~omafilcon A/ocufilcon D/methafilcon A: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A)/(ocufilcon D)/(methafilcon A)in the contra lateral eye."
71840|NCT02131402|O2|Outcome|Methafilcon A|Participants vision tested both eyes wearing Methafilcon A, prior to dispensing contralateral pairs.
71841|NCT02131402|O1|Outcome|Enfilcon A|Participants vision tested both eyes wearing enfilcon A, prior to dispensing contralateral pairs.
71842|NCT02131402|O2|Outcome|Ocufilcon D|Participants vision tested both eyes wearing ocufilcon D, prior to dispensing contralateral pairs.
71843|NCT02131402|O1|Outcome|Enfilcon A|Participants vision tested both eyes wearing enfilcon A, prior to dispensing contralateral pairs.
71844|NCT02131402|O2|Outcome|Omafilcon A|Participants vision tested both eyes wearing omafilcon A, prior to dispensing contralateral pairs.
71845|NCT02131402|O1|Outcome|Enfilcon A|Participants vision tested both eyes wearing enfilcon A, prior to dispensing contralateral pairs.
71846|NCT02131402|O2|Outcome|Methafilcon A|Participants surveyed at 1 hour post settling, wearing Methafilcon A in contralateral eye.
71847|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed at 1 hour post settling, wearing Enfilcon A in one eye.
71848|NCT02131402|O2|Outcome|Ocufilcon D|Participants surveyed at 1 hour post settling, wearing Ocufilcon D in contralateral eye.
71849|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed at 1 hour post settling, wearing Enfilcon A in one eye.
71850|NCT02131402|O2|Outcome|Omafilcon A|Participants surveyed after1 hour wearing Omafilcon A in contralateral eye.
71851|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed after 1 hour wearing Enfilcon A in one eye.
71852|NCT02131402|O2|Outcome|Methafilcon A|Participants surveyed at baseline, wearing Methafilcon A in contralateral eye.
71853|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed at baseline, wearing Enfilcon A in one eye.
71854|NCT02131402|O2|Outcome|Ocufilcon D|Surveyed after insertion at baseline, wearing Ocufilcon D in contralateral eye.
71855|NCT02131402|O1|Outcome|Enfilcon A|Surveyed after insertion at baseline, wearing Enfilcon A in one eye.
71856|NCT02131402|O2|Outcome|Omafilcon A|Participants surveyed at baseline, wearing Omafilcon A in contralateral eye
71857|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed at baseline, wearing Enfilcon A in one eye
71858|NCT02131402|O2|Outcome|Methafilcon A|Assessed at 1 hour post settling, wearing Methafilcon A in contralateral eye.
71859|NCT02131402|O1|Outcome|Enfilcon A|Assessed at 1 hour post settling, wearing Enfilcon A in one eye.
71860|NCT02131402|O2|Outcome|Ocufilcon D|Assessed after 1 hour post settling, wearing Ocufilcon D in contralateral eye.
71861|NCT02131402|O1|Outcome|Enfilcon A|Assessed after 1 hour post settling, wearing Enfilcon A in one eye.
71862|NCT02131402|O2|Outcome|Omafilcon A|Assessed after 1 hour post settling, wearing Omafilcon A in contralateral eye
71863|NCT02131402|O1|Outcome|Enfilcon A|Assessed after 1 hour post settling wearing Enfilcon A in one eye.
71864|NCT02131402|O2|Outcome|Methafilcon A|Assessed at 1 hour post settling. Push up test, wearing Methafilcon A in contralateral eye.
71865|NCT02131402|O1|Outcome|Enfilcon A|Assessed at 1 hour post settling. Push up test, wearing Enfilcon A in one eye.
71866|NCT02131402|O2|Outcome|Ocufilcon D|Assessed after 1 hour post settling. Push up test, wearing Ocufilcon D in contralateral eye.
71867|NCT02131402|O1|Outcome|Enfilcon A|Assessed after 1 hour post settling. Push up test, wearing Enfilcon A in one eye.
71868|NCT02131402|O2|Outcome|Omafilcon A|Assessed after 1 hour post settling. Push up test, wearing Omafilcon A in contralateral eye.
71869|NCT02131402|O1|Outcome|Enfilcon A|Assessed after 1 hour post settling. Push up test, wearing Enfilcon A in one eye.
71870|NCT02131402|O2|Outcome|Methafilcon A|Assessed at 1 hour post settling. Post-blink movement, wearing Ocufilcon D in contralateral eye.
71871|NCT02131402|O1|Outcome|Enfilcon A|Assessed at 1 hour post settling. Post-blink movement, wearing Enfilcon A in one eye.
71872|NCT02131402|O2|Outcome|Ocufilcon D|Assessed after 1 hour post settling. Post-blink movement, wearing Ocufilcon D in contralateral eye.
71873|NCT02131402|O1|Outcome|Enfilcon A|Assessed after 1 hour post settling. Post-blink movement, wearing Enfilcon A in one eye
71874|NCT02131402|O2|Outcome|Omafilcon A|Assessed after 1 hour post settling. Post-blink movement, wearing Omafilcon A in contralateral eye.
71875|NCT02131402|O1|Outcome|Enfilcon A|Assessed after 1 hour post settling. Post-blink movement, wearing Enfilcon A in one eye.
71876|NCT02131402|O2|Outcome|Methafilcon A|Wearing Methafilcon A in the contralateral eye, surveyed at 1 hour post settling.
71877|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye, surveyed at 1 hour post settling.
71878|NCT02131402|O2|Outcome|Ocufilcon D|Wearing Ocufilcon D in contralateral eye. Surveyed after 1 hour post settling.
71879|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed after 1 hour post settling.
71880|NCT02131402|O2|Outcome|Omafilcon A|Participants surveyed after 1 hour post settling, wearing Omafilcon A in contralateral eye
71881|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed after 1 hour post settling, wearing Enfilcon A in one eye
71882|NCT02131402|O2|Outcome|Methafilcon A|Subject surveyed after insertion of each lens for Pair #3 wearing Methafilcon A in the contralateral eye.
71883|NCT02131402|O1|Outcome|Enfilcon A|Subject surveyed after insertion of each lens for Pair #3 wearing Enfilcon A in one eye
71884|NCT02131402|O2|Outcome|Ocufilcon D|Wearing Ocufilcon D in the contralateral eye. Surveyed at insertion of each lens Pair #2.
71885|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed at insertion of each lens Pair #2.
71886|NCT02131402|O2|Outcome|Omafilcon A|Subject after insertion of Pair #1 at baseline wearing Omafilcon A in the contralateral eye.
71887|NCT02131402|O1|Outcome|Enfilcon A|Subject after insertion of Pair #1 at baseline wearing Enfilcon A in one eye
71888|NCT02131402|O2|Outcome|Methafilcon A|Participants surveyed after 1 post settling hour, wearing Methafilcon A in the contra lateral eye.
71889|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed after 1 hour post settling, wearing Enfilcon A in one eye
71890|NCT02131402|O2|Outcome|Ocufilcon D|Wearing Ocufilcon D in the contra lateral eye. Surveyed after 1 hour post settling for Pair #2.
71891|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed after 1 hour post settling for Pair #2
71892|NCT02131402|O2|Outcome|Omafilcon A|Participants surveyed after 1 hour post settling, wearing Omafilcon A in contralateral eye
71893|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed after 1 hour post settling, wearing Enfilcon A in one eye
71894|NCT02131402|O2|Outcome|Methafilcon A|Wearing Methafilcon A in the contra lateral eye. Participants surveyed at insertion.
71895|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Participants surveyed at insertion.
71896|NCT02131402|O2|Outcome|Omafilcon A|Participants surveyed at baseline, wearing Omafilcon A in the contra lateral eye.
71897|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed at baseline, wearing Enfilcon A in one eye
71898|NCT02131402|O2|Outcome|Ocufilcon D|Wearing Ocufilcon D in the contra lateral eye. Surveyed after insertion of each lens Pair #2 (at insertion).
71899|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed after insertion of each lens Pair #2 (at insertion).
71900|NCT02131402|O2|Outcome|Methafilcon A|Wearing Methafilcon A in the contralateral eye. Surveyed after 1 hour of lens wear for each lens at lens removal Pair #3.
71901|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed after 1 hour of lens wear for each lens at lens removal Pair #3.
71902|NCT02131402|O2|Outcome|Ocufilcon D|Wearing Ocufilcon D in the contralateral eye. Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #2
71903|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #2.
71904|NCT02131402|O2|Outcome|Omafilcon A|Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
71905|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.
71906|NCT02131402|E3|Reported Event|Enfilcon A / Methafilcon A|"Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.~methafilcon A: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (methafilcon A) in the contra lateral eye."
71907|NCT02131402|E2|Reported Event|Enfilcon A / Ocufilcon D|"Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.~ocufilcon D: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (ocufilcon D) in the contra lateral eye."
71908|NCT02131402|E1|Reported Event|Enfilcon A / Omafilcon A|"Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.~omafilcon A: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A) in the contra lateral eye."
71909|NCT02131324|B3|Baseline|Total|Total of all reporting groups
71910|NCT02131324|B2|Baseline|Comp01|Comp01 Comparator
71911|NCT02131324|B1|Baseline|DFD06|DFD06 Active
71912|NCT02131324|P2|Participant Flow|DFD06 Cream|"applied twice a day for 15 days~DFD06 Cream"
71913|NCT02131324|P1|Participant Flow|Comp01|"applied twice a day for 15 days~Comp01"
71914|NCT02131324|O2|Outcome|DFD06 Cream|"applied twice a day for 15 days~DFD06 Cream"
71915|NCT02131324|O1|Outcome|Clobetasol Propionate Cream, 0.05%|"applied twice a day for 15 days~Clobetasol Propionate Cream, 0.05%"
71916|NCT02131324|E2|Reported Event|DFD06 Cream|"applied twice a day for 15 days~DFD06 Cream"
71917|NCT02131324|E1|Reported Event|Clobetasol Propionate Cream, 0.05%|"applied twice a day for 15 days~Clobetasol Propionate Cream 0.05%"
71918|NCT02131311|B1|Baseline|Pessary|disposable, single-use pessary
71919|NCT02131311|P1|Participant Flow|Pessary|disposable, single-use pessary
71920|NCT02131311|O1|Outcome|Pessary|disposable, single-use pessary
71921|NCT02131311|O1|Outcome|Pessary|disposable, single-use pessary
71922|NCT02131311|O1|Outcome|Pessary|disposable, single-use pessary
71923|NCT02131311|O1|Outcome|Pessary|disposable, single-use pessary
71924|NCT02131311|O1|Outcome|Pessary|disposable, single-use pessary
71925|NCT02131311|O1|Outcome|Pessary|disposable, single-use pessary
71926|NCT02131311|O1|Outcome|Pessary|"disposable, single-use pessary~disposable, single-use pessary"
71927|NCT02131311|E1|Reported Event|Pessary|disposable, single-use pessary
71928|NCT02131272|B3|Baseline|Total|Total of all reporting groups
71929|NCT02131272|B2|Baseline|Insulin NPH + Metformin + Diet/Exercise|Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1−0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
71930|NCT02131272|B1|Baseline|Insulin Detemir + Metformin + Diet/Exercise|Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1−0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
71931|NCT02131272|P2|Participant Flow|Insulin NPH + Metformin + Diet/Exercise|Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1−0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
71932|NCT02131272|P1|Participant Flow|Insulin Detemir + Metformin + Diet/Exercise|Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1−0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
71933|NCT02131272|O2|Outcome|Insulin NPH + Metformin + Diet/Exercise|Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1−0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
71934|NCT02131272|O1|Outcome|Insulin Detemir + Metformin + Diet/Exercise|Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1−0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
71935|NCT02131272|O2|Outcome|Insulin NPH + Metformin + Diet/Exercise|Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1−0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
71936|NCT02131272|O1|Outcome|Insulin Detemir + Metformin + Diet/Exercise|Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1−0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
71937|NCT02131272|O2|Outcome|Insulin NPH + Metformin + Diet/Exercise|Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1−0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
71938|NCT02131272|O1|Outcome|Insulin Detemir + Metformin + Diet/Exercise|Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1−0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
71939|NCT02131272|O2|Outcome|Insulin NPH + Metformin + Diet/Exercise|Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1−0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
71940|NCT02131272|O1|Outcome|Insulin Detemir + Metformin + Diet/Exercise|Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1−0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
71941|NCT02131272|O2|Outcome|Insulin NPH + Metformin + Diet/Exercise|Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1−0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
71942|NCT02131272|O1|Outcome|Insulin Detemir + Metformin + Diet/Exercise|Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1−0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
71943|NCT02131272|O2|Outcome|Insulin NPH + Metformin + Diet/Exercise|Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1−0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
71944|NCT02131272|O1|Outcome|Insulin Detemir + Metformin + Diet/Exercise|Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1−0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
71945|NCT02131272|O2|Outcome|Insulin NPH + Metformin + Diet/Exercise|Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1−0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
71946|NCT02131272|O1|Outcome|Insulin Detemir + Metformin + Diet/Exercise|Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1−0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
71947|NCT02131272|E2|Reported Event|Insulin NPH + Metformin + Diet/Exercise|Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1−0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
71948|NCT02131272|E1|Reported Event|Insulin Detemir + Metformin + Diet/Exercise|Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1−0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
71949|NCT02131233|B3|Baseline|Total|Total of all reporting groups
71950|NCT02131233|B2|Baseline|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
71951|NCT02131233|B1|Baseline|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
71952|NCT02131233|P2|Participant Flow|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
71953|NCT02131233|P1|Participant Flow|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
71954|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
71955|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
71956|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
71957|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
71958|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
71959|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
71960|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
71961|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
71962|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
71963|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
71964|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
71965|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
71966|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
71967|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
71968|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
71969|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
71970|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
71971|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
71972|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
71973|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
71974|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
72875|NCT02126670|E3|Reported Event|ACT01 Plus Comp03|"ACT01 Cream in combination with Comp03 Cream, once daily, 29 days~ACT01~Comp03"
71975|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
71976|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
71977|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
71978|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
71979|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
71980|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
71981|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
71982|NCT02131233|E2|Reported Event|Raltegravir 400 mg BID + Truvada|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
71983|NCT02131233|E1|Reported Event|Raltegravir 1200 mg QD + Truvada|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
71984|NCT02131064|B3|Baseline|Total|Total of all reporting groups
71985|NCT02131064|B2|Baseline|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
71986|NCT02131064|B1|Baseline|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
71987|NCT02131064|P2|Participant Flow|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
71988|NCT02131064|P1|Participant Flow|TCH + P|Participants received pertuzumab 840 milligrams (mg) (loading dose) and 420 mg (maintenance dose) intravenous (IV) infusion, trastuzumab 8 milligrams per kilogram (mg/kg) (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 milligrams per square meter (mg/m^2) IV infusion and carboplatin at a dose to achieve an area under the curve (AUC) of 6 milligrams per milliliter* minute (mg/mL*min) IV infusion every 3 weeks (q3w) for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
71989|NCT02131064|O1|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
71990|NCT02131064|O1|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
71991|NCT02131064|O1|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
71992|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
71993|NCT02131064|O1|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
71994|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
71995|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
71996|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
71997|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
71998|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
71999|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
72000|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
72001|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
72002|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
72003|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
72004|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
72005|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
72006|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
72007|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
72008|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
72009|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
72010|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
72011|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
72012|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
72078|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
72013|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
72014|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
72015|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
72016|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
72017|NCT02131064|E2|Reported Event|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
72018|NCT02131064|E1|Reported Event|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
72019|NCT02130999|B1|Baseline|Overall Number of Baseline Participants|14 subjects total participated in the study
72020|NCT02130999|P2|Participant Flow|Sequence B|"Single I.V. dose of tasimelteon 2 mg on Day 1~Single oral dose of tasimelteon 20 mg on Day 6~tasimelteon 20 mg capsule~tasimelteon 2 mg I.V."
72021|NCT02130999|P1|Participant Flow|Sequence A|"Single oral dose of tasimelteon 20 mg on Day 1~Single I.V. dose of tasimelteon 2 mg on Day 6~tasimelteon 20 mg capsule~tasimelteon 2 mg I.V."
72022|NCT02130999|O3|Outcome|All Subjects|
72023|NCT02130999|O2|Outcome|Tasimelteon 2mg IV|
72024|NCT02130999|O1|Outcome|Tasimelteon 20mg Oral|
72025|NCT02130999|O3|Outcome|All Subjects|
72026|NCT02130999|O2|Outcome|Tasimelteon 2mg IV|
72027|NCT02130999|O1|Outcome|Tasimelteon 20mg Oral|
72028|NCT02130999|O2|Outcome|IV (2 mg)|
72029|NCT02130999|O1|Outcome|Oral (20 mg)|
72030|NCT02130999|O2|Outcome|IV (2 mg)|
72031|NCT02130999|O1|Outcome|Oral (20 mg)|
72032|NCT02130999|O2|Outcome|IV (2 mg)|
72033|NCT02130999|O1|Outcome|Oral (20 mg)|
72034|NCT02130999|O2|Outcome|IV (2 mg)|
72035|NCT02130999|O1|Outcome|Oral (20 mg)|
72036|NCT02130999|O2|Outcome|IV (2 mg)|
72037|NCT02130999|O1|Outcome|Oral (20 mg)|
72038|NCT02130999|O2|Outcome|IV (2 mg)|
72039|NCT02130999|O1|Outcome|Oral (20 mg)|
72040|NCT02130999|O2|Outcome|IV (2 mg)|
72041|NCT02130999|O1|Outcome|Oral (20 mg)|
72042|NCT02130999|O1|Outcome|Absolute Bioavailability|
72043|NCT02130999|E3|Reported Event|All Subjects|
72044|NCT02130999|E2|Reported Event|Tasimelteon 2mg IV|
72045|NCT02130999|E1|Reported Event|Tasimelteon 20mg Oral|
72046|NCT02130635|B10|Baseline|Total|Total of all reporting groups
72047|NCT02130635|B9|Baseline|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
72048|NCT02130635|B8|Baseline|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72049|NCT02130635|B7|Baseline|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
72050|NCT02130635|B6|Baseline|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72051|NCT02130635|B5|Baseline|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72052|NCT02130635|B4|Baseline|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72053|NCT02130635|B3|Baseline|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
72148|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
72054|NCT02130635|B2|Baseline|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
72055|NCT02130635|B1|Baseline|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
72056|NCT02130635|P9|Participant Flow|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
72057|NCT02130635|P8|Participant Flow|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72058|NCT02130635|P7|Participant Flow|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
72059|NCT02130635|P6|Participant Flow|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72060|NCT02130635|P5|Participant Flow|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72061|NCT02130635|P4|Participant Flow|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72062|NCT02130635|P3|Participant Flow|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
72063|NCT02130635|P2|Participant Flow|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
72064|NCT02130635|P1|Participant Flow|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
72065|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
72066|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72067|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
72068|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72069|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72070|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72071|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
72072|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
72073|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72074|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
72075|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72076|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72077|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72079|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
72080|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72081|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
72082|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72083|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72084|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72085|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
72086|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
72087|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72088|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
72089|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72090|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72091|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72092|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
72093|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
72094|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72095|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
72096|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72097|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72098|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72099|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
72100|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
72101|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72876|NCT02126670|E2|Reported Event|ACT01 Plus Comp02|"ACT01 Cream in combination with Comp02 Cream, once daily, 29 days~ACT01~Comp02"
72102|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
72103|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72104|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72105|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72106|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
72107|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
72108|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72109|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
72110|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72111|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72112|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72113|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
72114|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
72115|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72116|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
72117|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72118|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72119|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72120|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
72121|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
72122|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72123|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
72124|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72877|NCT02126670|E1|Reported Event|ACT01 Plus Comp01|"ACT01 Cream in combination with Comp01 Cream, once daily, 29 days~ACT01~Comp01"
72125|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72126|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72127|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
72128|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
72129|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72130|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
72131|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72132|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72133|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72134|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
72135|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
72136|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72137|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
72138|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72139|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72140|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72141|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
72142|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
72143|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72144|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
72145|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72146|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72147|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72878|NCT02126319|B3|Baseline|Total|Total of all reporting groups
72149|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
72150|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72151|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
72152|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72153|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72154|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72155|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
72156|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
72157|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72158|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
72159|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72160|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72161|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72162|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
72163|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
72164|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72165|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
72166|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72167|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72168|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72169|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
72170|NCT02130635|O6|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
72171|NCT02130635|O5|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
73658|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
72172|NCT02130635|O4|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
72173|NCT02130635|O3|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72174|NCT02130635|O2|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72175|NCT02130635|O1|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72176|NCT02130635|O1|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
72177|NCT02130635|O6|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
72178|NCT02130635|O5|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72179|NCT02130635|O4|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
72180|NCT02130635|O3|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72181|NCT02130635|O2|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72182|NCT02130635|O1|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72183|NCT02130635|O1|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
72184|NCT02130635|O6|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
72185|NCT02130635|O5|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72186|NCT02130635|O4|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
72187|NCT02130635|O3|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72188|NCT02130635|O2|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72189|NCT02130635|O1|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72190|NCT02130635|O1|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
72191|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
72192|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72193|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
72605|NCT02128542|O2|Outcome|SOF+RBV 12 Weeks (TE)|Treatment-experienced participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
72194|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72195|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72196|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72197|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
72198|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
72199|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
72200|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
72201|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
72202|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
72203|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
72204|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
72205|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
72206|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
72207|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
72208|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
72209|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
72210|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
72211|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
72212|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
72213|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
72214|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
72215|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
72216|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
72217|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
72218|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
72219|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
72220|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
72221|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
72222|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
72223|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
72224|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
72225|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
72226|NCT02130635|E9|Reported Event|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
72227|NCT02130635|E8|Reported Event|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72228|NCT02130635|E7|Reported Event|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
72229|NCT02130635|E6|Reported Event|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
72230|NCT02130635|E5|Reported Event|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72231|NCT02130635|E4|Reported Event|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
72232|NCT02130635|E3|Reported Event|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
72233|NCT02130635|E2|Reported Event|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
72234|NCT02130635|E1|Reported Event|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
72235|NCT02130622|B3|Baseline|Total|Total of all reporting groups
72236|NCT02130622|B2|Baseline|Sugar Pill|"Placebo P.O. t.i.d. for 4 weeks~Sugar pill"
72237|NCT02130622|B1|Baseline|Promethazine|"Promethazine 12.5 mg P.O. t.i.d. for 4 weeks~Promethazine"
72238|NCT02130622|P2|Participant Flow|Sugar Pill|"Placebo P.O. t.i.d. for 4 weeks~Sugar pill"
72239|NCT02130622|P1|Participant Flow|Promethazine|"Promethazine 12.5 mg P.O. t.i.d. for 4 weeks~Promethazine"
72240|NCT02130622|O2|Outcome|Sugar Pill|"Placebo P.O. t.i.d. for 4 weeks~Sugar pill"
72241|NCT02130622|O1|Outcome|Promethazine|"Promethazine 12.5 mg P.O. t.i.d. for 4 weeks~Promethazine"
72242|NCT02130622|O2|Outcome|Sugar Pill|"Placebo P.O. t.i.d. for 4 weeks~Sugar pill"
72243|NCT02130622|O1|Outcome|Promethazine|"Promethazine 12.5 mg P.O. t.i.d. for 4 weeks~Promethazine"
72244|NCT02130622|O2|Outcome|Sugar Pill|"Placebo P.O. t.i.d. for 4 weeks~Sugar pill"
72245|NCT02130622|O1|Outcome|Promethazine|"Promethazine 12.5 mg P.O. t.i.d. for 4 weeks~Promethazine"
72246|NCT02130622|O2|Outcome|Sugar Pill|"Placebo P.O. t.i.d. for 4 weeks~Sugar pill"
72247|NCT02130622|O1|Outcome|Promethazine|"Promethazine 12.5 mg P.O. t.i.d. for 4 weeks~Promethazine"
72248|NCT02130622|E2|Reported Event|Sugar Pill|"Placebo P.O. t.i.d. for 4 weeks~Sugar pill"
72249|NCT02130622|E1|Reported Event|Promethazine|"Promethazine 12.5 mg P.O. t.i.d. for 4 weeks~Promethazine"
72250|NCT02130284|B1|Baseline|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor~Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
72251|NCT02130284|P1|Participant Flow|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor~Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
72252|NCT02130284|O1|Outcome|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor~Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
72253|NCT02130284|O1|Outcome|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor~Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
72254|NCT02130284|O1|Outcome|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor~Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
72255|NCT02130284|O1|Outcome|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor~Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
72256|NCT02130284|O1|Outcome|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor~Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
72292|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72257|NCT02130284|O1|Outcome|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor~Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
72258|NCT02130284|O1|Outcome|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor~Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
72259|NCT02130284|O1|Outcome|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor~Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
72260|NCT02130284|E1|Reported Event|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor~Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
72261|NCT02130258|B3|Baseline|Total|Total of all reporting groups
72262|NCT02130258|B2|Baseline|<30% Pain Relief|All subjects have radicular pain and are scheduled to receive an epidural steroid injection (ESI) as a treatment. The ESI treatment is conducted by the subject's clinical physician and is not given as part of the research study procedures. Quantitative Sensory Testing (QST) will be conducted before and after the ESI treatment. QST consists of hot and cold temperature testing using the QST device. This group of subjects received less than 30% pain relief.
72263|NCT02130258|B1|Baseline|>30% Pain Relief|All subjects have radicular pain and are scheduled to receive an epidural steroid injection (ESI) as a treatment. The ESI treatment is conducted by the subject's clinical physician and is not given as part of the research study procedures. Quantitative Sensory Testing (QST) will be conducted before and after the ESI treatment. QST consists of hot and cold temperature testing using the QST device. This group of subjects received greater than 30% pain relief.
72264|NCT02130258|P2|Participant Flow|<30% Pain Relief|All subjects have radicular pain and are scheduled to receive an epidural steroid injection (ESI) as a treatment. The ESI treatment is conducted by the subject's clinical physician and is not given as part of the research study procedures. Quantitative Sensory Testing (QST) will be conducted before and after the ESI treatment. QST consists of hot and cold temperature testing using the QST device. This group of subjects received less than 30% pain relief.
72265|NCT02130258|P1|Participant Flow|>30% Pain Relief|All subjects have radicular pain and are scheduled to receive an epidural steroid injection (ESI) as a treatment. The ESI treatment is conducted by the subject's clinical physician and is not given as part of the research study procedures. Quantitative Sensory Testing (QST) will be conducted before and after the ESI treatment. QST consists of hot and cold temperature testing using the QST device. This group of subjects received greater than 30% pain relief.
72266|NCT02130258|O2|Outcome|<30% Pain Relief|All subjects have radicular pain and are scheduled to receive an epidural steroid injection (ESI) as a treatment. The ESI treatment is conducted by the subject's clinical physician and is not given as part of the research study procedures. Quantitative Sensory Testing (QST) will be conducted before and after the ESI treatment. QST consists of hot and cold temperature testing using the QST device. This group of subjects received less than 30% pain relief.
72267|NCT02130258|O1|Outcome|>30% Pain Relief|All subjects have radicular pain and are scheduled to receive an epidural steroid injection (ESI) as a treatment. The ESI treatment is conducted by the subject's clinical physician and is not given as part of the research study procedures. Quantitative Sensory Testing (QST) will be conducted before and after the ESI treatment. QST consists of hot and cold temperature testing using the QST device. This group of subjects received greater than 30% pain relief.
72268|NCT02130258|O2|Outcome|<30% Pain Relief|All subjects have radicular pain and are scheduled to receive an epidural steroid injection (ESI) as a treatment. The ESI treatment is conducted by the subject's clinical physician and is not given as part of the research study procedures. Quantitative Sensory Testing (QST) will be conducted before and after the ESI treatment. QST consists of hot and cold temperature testing using the QST device. This group of subjects received less than 30% pain relief.
72269|NCT02130258|O1|Outcome|>30% Pain Relief|All subjects have radicular pain and are scheduled to receive an epidural steroid injection (ESI) as a treatment. The ESI treatment is conducted by the subject's clinical physician and is not given as part of the research study procedures. Quantitative Sensory Testing (QST) will be conducted before and after the ESI treatment. QST consists of hot and cold temperature testing using the QST device. This group of subjects received greater than 30% pain relief.
72270|NCT02130258|O2|Outcome|<30% Pain Relief|All subjects have radicular pain and are scheduled to receive an epidural steroid injection (ESI) as a treatment. The ESI treatment is conducted by the subject's clinical physician and is not given as part of the research study procedures. Quantitative Sensory Testing (QST) will be conducted before and after the ESI treatment. QST consists of hot and cold temperature testing using the QST device. This group of subjects received less than 30% pain relief.
72271|NCT02130258|O1|Outcome|>30% Pain Relief|All subjects have radicular pain and are scheduled to receive an epidural steroid injection (ESI) as a treatment. The ESI treatment is conducted by the subject's clinical physician and is not given as part of the research study procedures. Quantitative Sensory Testing (QST) will be conducted before and after the ESI treatment. QST consists of hot and cold temperature testing using the QST device. This group of subjects received greater than 30% pain relief.
72272|NCT02130258|E2|Reported Event|<30% Pain Relief|All subjects have radicular pain and are scheduled to receive an epidural steroid injection (ESI) as a treatment. The ESI treatment is conducted by the subject's clinical physician and is not given as part of the research study procedures. Quantitative Sensory Testing (QST) will be conducted before and after the ESI treatment. QST consists of hot and cold temperature testing using the QST device. This group of subjects received less than 30% pain relief.
73659|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
72273|NCT02130258|E1|Reported Event|>30% Pain Relief|All subjects have radicular pain and are scheduled to receive an epidural steroid injection (ESI) as a treatment. The ESI treatment is conducted by the subject's clinical physician and is not given as part of the research study procedures. Quantitative Sensory Testing (QST) will be conducted before and after the ESI treatment. QST consists of hot and cold temperature testing using the QST device. This group of subjects received greater than 30% pain relief.
72274|NCT02130193|B3|Baseline|Total|Total of all reporting groups
72275|NCT02130193|B2|Baseline|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72276|NCT02130193|B1|Baseline|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72277|NCT02130193|P3|Participant Flow|Part B: 52-week Double-blind Period: DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72278|NCT02130193|P2|Participant Flow|Part B: 52-week Double-blind Period: Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72279|NCT02130193|P1|Participant Flow|Part A: 4-week Open-label Period: DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72280|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72281|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72282|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72283|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72284|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72285|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72286|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72287|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72288|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72289|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72290|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72291|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72606|NCT02128542|O1|Outcome|SOF+RBV 12 Weeks (TN)|Treatment-naive participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
72293|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72294|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72295|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72296|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72297|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72298|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72299|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72300|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72301|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72302|NCT02130193|O1|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72303|NCT02130193|O1|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72304|NCT02130193|O1|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72305|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72306|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72307|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72308|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72309|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72310|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72311|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72364|NCT02129777|P6|Participant Flow|Open-Label Period: Namilumab 80 mg|Namilumab 80 mg, single injection, subcutaneously, every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
72312|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72313|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72314|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72315|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72316|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72317|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72318|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72319|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72320|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72321|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72322|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72323|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72324|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72325|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72326|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72327|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72328|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72329|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72330|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72331|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72332|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72333|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72334|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72335|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72336|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72337|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72338|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72339|NCT02130193|E3|Reported Event|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72340|NCT02130193|E2|Reported Event|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72341|NCT02130193|E1|Reported Event|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
72342|NCT02130063|B3|Baseline|Total|Total of all reporting groups
72343|NCT02130063|B2|Baseline|Iron Sucrose (Venofer®)|"iron sucrose (Venofer®)~iron sucrose (Venofer®)"
72344|NCT02130063|B1|Baseline|Iron Isomaltoside 1000 (Monofer®)|"iron isomaltoside 1000 (Monofer®)~iron isomaltoside 1000 (Monofer®)"
72345|NCT02130063|P2|Participant Flow|Iron Sucrose (Venofer®)|"iron sucrose (Venofer®)~iron sucrose (Venofer®)"
72346|NCT02130063|P1|Participant Flow|Iron Isomaltoside 1000 (Monofer®)|"iron isomaltoside 1000 (Monofer®)~iron isomaltoside 1000 (Monofer®)"
72347|NCT02130063|O2|Outcome|Iron Sucrose (Venofer®)|"iron sucrose (Venofer®)~iron sucrose (Venofer®)"
72348|NCT02130063|O1|Outcome|Iron Isomaltoside 1000 (Monofer®)|"iron isomaltoside 1000 (Monofer®)~iron isomaltoside 1000 (Monofer®)"
72349|NCT02130063|O2|Outcome|Iron Sucrose (Venofer®)|"iron sucrose (Venofer®)~iron sucrose (Venofer®)"
72350|NCT02130063|O1|Outcome|Iron Isomaltoside 1000 (Monofer®)|"iron isomaltoside 1000 (Monofer®)~iron isomaltoside 1000 (Monofer®)"
72351|NCT02130063|O2|Outcome|Iron Sucrose (Venofer®)|"iron sucrose (Venofer®)~iron sucrose (Venofer®)"
72352|NCT02130063|O1|Outcome|Iron Isomaltoside 1000 (Monofer®)|"iron isomaltoside 1000 (Monofer®)~iron isomaltoside 1000 (Monofer®)"
72353|NCT02130063|O2|Outcome|Iron Sucrose (Venofer®)|"iron sucrose (Venofer®)~iron sucrose (Venofer®)"
72354|NCT02130063|O1|Outcome|Iron Isomaltoside 1000 (Monofer®)|"iron isomaltoside 1000 (Monofer®)~iron isomaltoside 1000 (Monofer®)"
72355|NCT02130063|E2|Reported Event|Iron Sucrose (Venofer®)|"iron sucrose (Venofer®)~iron sucrose (Venofer®)"
72356|NCT02130063|E1|Reported Event|Iron Isomaltoside 1000 (Monofer®)|"iron isomaltoside 1000 (Monofer®)~iron isomaltoside 1000 (Monofer®)"
72357|NCT02129777|B6|Baseline|Total|Total of all reporting groups
72358|NCT02129777|B5|Baseline|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72359|NCT02129777|B4|Baseline|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72360|NCT02129777|B3|Baseline|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72361|NCT02129777|B2|Baseline|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72362|NCT02129777|B1|Baseline|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72363|NCT02129777|P7|Participant Flow|Open-Label Period: Namilumab 150 mg|Namilumab 150 mg, single injection, subcutaneously from Week 8 and then every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
72365|NCT02129777|P5|Participant Flow|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72366|NCT02129777|P4|Participant Flow|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72367|NCT02129777|P3|Participant Flow|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72368|NCT02129777|P2|Participant Flow|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72369|NCT02129777|P1|Participant Flow|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72370|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72371|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72372|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72373|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72374|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72375|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72376|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72377|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72378|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72379|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72380|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72381|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72382|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72383|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72384|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72385|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72386|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72387|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72388|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72389|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72390|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
73660|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
72391|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72392|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72393|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72394|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72395|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72396|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72397|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72398|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72399|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72400|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72401|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72402|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72403|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72404|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72405|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72406|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72407|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72408|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72409|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72410|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72411|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72412|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72413|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72414|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72415|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72416|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72536|NCT02128997|E1|Reported Event|Closed Incision Wound Vacuum (Prevena)|"Closed incision wound vacuum (Prevena)~Closed incision wound vacuum (Prevena): wound vacuum to be placed on a closed incision"
72417|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72418|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72419|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72420|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72421|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72422|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72423|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72424|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72425|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72426|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72427|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72428|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72429|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72430|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72431|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72432|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72433|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72434|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72435|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72436|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72437|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72438|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72439|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72440|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72441|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72442|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72537|NCT02128932|B4|Baseline|Total|Total of all reporting groups
73661|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
72443|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72444|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72445|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72446|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72447|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72448|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72449|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72450|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72451|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72452|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72453|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72454|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72455|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72456|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72457|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72458|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72459|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72460|NCT02129777|E12|Reported Event|Follow-up: Namilumab 150 mg|Participants who received namilumab 150 mg injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
72461|NCT02129777|E11|Reported Event|Follow-up Period: Namilumab 80 mg|Participants who received namilumab 80 mg injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
72462|NCT02129777|E10|Reported Event|Follow-up Period: Namilumab 50 mg|Participants who received namilumab 50 mg injections during the double-blind treatment were to be followed-up after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
72463|NCT02129777|E9|Reported Event|Follow-up Period: Namilumab 20 mg|Participants who received namilumab 20 mg injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
72464|NCT02129777|E8|Reported Event|Follow-up Period: Placebo|Participants who received namilumab-matching placebo injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
72465|NCT02129777|E7|Reported Event|Open-Label Period: Namilumab 150 mg|Namilumab 150 mg, single injection, subcutaneously from Week 8 and then every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
72466|NCT02129777|E6|Reported Event|Open-Label Period: Namilumab 80 mg|Namilumab 80 mg, single injection, subcutaneously, every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
72467|NCT02129777|E5|Reported Event|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72468|NCT02129777|E4|Reported Event|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
73662|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
72469|NCT02129777|E3|Reported Event|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72470|NCT02129777|E2|Reported Event|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72471|NCT02129777|E1|Reported Event|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
72472|NCT02129725|B3|Baseline|Total|Total of all reporting groups
72473|NCT02129725|B2|Baseline|Placebo|Subjects consented for the biopsy substudy and randomized
72474|NCT02129725|B1|Baseline|Sildenafil|Subjects consented for the biopsy substudy and randomized
72475|NCT02129725|P2|Participant Flow|Placebo|"In the parent study, subjects are randomized to matching placebo~muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling."
72476|NCT02129725|P1|Participant Flow|Sildenafil|"In the parent study, subjects are randomized to sildenafil 25 mg tid.~muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling."
72477|NCT02129725|O2|Outcome|Placebo|"In the parent study, subjects are randomized to matching placebo~muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling."
72478|NCT02129725|O1|Outcome|Sildenafil|"In the parent study, subjects are randomized to sildenafil 25 mg tid.~muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling."
72479|NCT02129725|E2|Reported Event|Placebo|"In the parent study, subjects are randomized to matching placebo~muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling."
72480|NCT02129725|E1|Reported Event|Sildenafil|"In the parent study, subjects are randomized to sildenafil 25 mg tid.~muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling."
72481|NCT02129608|B4|Baseline|Total|Total of all reporting groups
72482|NCT02129608|B3|Baseline|LLLT and Lorcaserin|"LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.~Lorcaserin: 10 mg pills twice daily for 12 weeks."
72483|NCT02129608|B2|Baseline|Lorcaserin|"locarserin monotherapy - 10 mg, twice daily for 12 weeks~Lorcaserin: 10 mg pills twice daily for 12 weeks."
72484|NCT02129608|B1|Baseline|LLLT|"Low Level Laser Therapy (LLLT) once a week for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks."
72485|NCT02129608|P3|Participant Flow|LLLT and Lorcaserin|"LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.~Lorcaserin: 10 mg pills twice daily for 12 weeks."
72486|NCT02129608|P2|Participant Flow|Lorcaserin|"locarserin monotherapy - 10 mg, twice daily for 12 weeks~Lorcaserin: 10 mg pills twice daily for 12 weeks."
72487|NCT02129608|P1|Participant Flow|LLLT|"Low Level Laser Therapy (LLLT) once a week for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks."
72488|NCT02129608|O3|Outcome|LLLT and Lorcaserin|"LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.~Lorcaserin: 10 mg pills twice daily for 12 weeks."
72489|NCT02129608|O2|Outcome|Lorcaserin|"locarserin monotherapy - 10 mg, twice daily for 12 weeks~Lorcaserin: 10 mg pills twice daily for 12 weeks."
72490|NCT02129608|O1|Outcome|LLLT|"Low Level Laser Therapy (LLLT) once a week for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks."
72491|NCT02129608|O3|Outcome|LLLT and Lorcaserin|"LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.~Lorcaserin: 10 mg pills twice daily for 12 weeks."
72492|NCT02129608|O2|Outcome|Lorcaserin|"locarserin monotherapy - 10 mg, twice daily for 12 weeks~Lorcaserin: 10 mg pills twice daily for 12 weeks."
72493|NCT02129608|O1|Outcome|LLLT|"Low Level Laser Therapy (LLLT) once a week for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks."
72494|NCT02129608|E3|Reported Event|LLLT and Lorcaserin|"LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.~Lorcaserin: 10 mg pills twice daily for 12 weeks."
72495|NCT02129608|E2|Reported Event|Lorcaserin|"locarserin monotherapy - 10 mg, twice daily for 12 weeks~Lorcaserin: 10 mg pills twice daily for 12 weeks."
72496|NCT02129608|E1|Reported Event|LLLT|"Low Level Laser Therapy (LLLT) once a week for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks."
72497|NCT02129192|B3|Baseline|Total|Total of all reporting groups
72498|NCT02129192|B2|Baseline|Sequence RTTR|"Subjects were treated telmisartan 80 mg (T80), amlodipine 5 mg (A5) and hydrochlorothiazide (HCTZ) 12.5 mg (H12.5 mg) in the following order from period 1 to period 4:~R - T - T - R.~The treatments were administered following an overnight fast of at least 10 hours."
72499|NCT02129192|B1|Baseline|Sequence TRRTT|"Subjects were treated with telmisartan 80 mg (T80), amlodipine 5 mg (A5) and hydrochlorothiazide (HCTZ) 12.5 mg (H12.5 mg) in the following order from period 1 to period 5:~T (test product: T80/A5/H12.5 mg fixed dose combination (FDC) tablet) - R (reference products: T80/H12.5 mg FDC tablet and A5 mg capsule) - R - T - T.~Treatment periods 1 to 4 were administered following an overnight fast of at least 10 hours, in treatment period 5 after an overnight fast of at least 10 hours, a Japanese-style breakfast was served 30 minutes before drug administration"
72500|NCT02129192|P2|Participant Flow|Sequence RTTR|"Subjects were treated telmisartan 80 mg (T80), amlodipine 5 mg (A5) and hydrochlorothiazide (HCTZ) 12.5 mg (H12.5 mg) in the following order from period 1 to period 4:~R - T - T - R.~The treatments were administered following an overnight fast of at least 10 hours."
72501|NCT02129192|P1|Participant Flow|Sequence TRRTT|"Subjects were treated with telmisartan 80 mg (T80), amlodipine 5 mg (A5) and hydrochlorothiazide (HCTZ) 12.5 mg (H12.5 mg) in the following order from period 1 to period 5:~T (test product: T80/A5/H12.5 mg fixed dose combination (FDC) tablet) - R (reference products: T80/H12.5 mg FDC tablet and A5 mg capsule) - R - T - T.~Treatment periods 1 to 4 were administered following an overnight fast of at least 10 hours, in treatment period 5 after an overnight fast of at least 10 hours, a Japanese-style breakfast was served 30 minutes before drug administration"
72502|NCT02129192|O2|Outcome|T80/A5/H12.5 FDC Fasted|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet in fasted condition
72503|NCT02129192|O1|Outcome|T80/A5/H12.5 mg FDC Fed|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet in fed condition
72504|NCT02129192|O2|Outcome|T80/H12.5 FDC + A5 Capsule|Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet and Amlodipine 5 mg capsule
72505|NCT02129192|O1|Outcome|T80/A5/H12.5 mg FDC|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet
72506|NCT02129192|O2|Outcome|T80/A5/H12.5 FDC Fasted|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet in fasted condition
72507|NCT02129192|O1|Outcome|T80/A5/H12.5 mg FDC Fed|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet in fed condition
72508|NCT02129192|O2|Outcome|T80/H12.5 FDC + A5 Capsule|Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet and Amlodipine 5 mg capsule
72509|NCT02129192|O1|Outcome|T80/A5/H12.5 mg FDC|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet
72510|NCT02129192|O2|Outcome|T80/A5/H12.5 FDC Fasted|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet in fasted condition
72511|NCT02129192|O1|Outcome|T80/A5/H12.5 mg FDC Fed|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet in fed condition
72512|NCT02129192|O2|Outcome|T80/H12.5 FDC + A5 Capsule|Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet and Amlodipine 5 mg capsule
72513|NCT02129192|O1|Outcome|T80/A5/H12.5 mg FDC|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet
72514|NCT02129192|E3|Reported Event|Total.|All participants randomised into the study.
72515|NCT02129192|E2|Reported Event|T80/H12.5 FDC + A5 Capsule|Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet and Amlodipine 5 mg capsule
72516|NCT02129192|E1|Reported Event|T80/A5/H12.5 mg FDC|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet
72517|NCT02129062|B1|Baseline|Treatment (Ibrutinib)|Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
72518|NCT02129062|P1|Participant Flow|Treatment (Ibrutinib)|Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
72519|NCT02129062|O1|Outcome|Treatment (Ibrutinib)|Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
72520|NCT02129062|O1|Outcome|Treatment (Ibrutinib)|Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
72521|NCT02129062|E1|Reported Event|Treatment (Ibrutinib)|Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
72522|NCT02128997|B3|Baseline|Total|Total of all reporting groups
72523|NCT02128997|B2|Baseline|Routine Wound Care|This arm includes patients having a cesarean section with routine wound care
72524|NCT02128997|B1|Baseline|Closed Incision Wound Vacuum (Prevena)|"Closed incision wound vacuum (Prevena)~Closed incision wound vacuum (Prevena): wound vacuum to be placed on a closed incision"
72525|NCT02128997|P2|Participant Flow|Routine Wound Care|This arm includes patients having a cesarean section with routine wound care
72526|NCT02128997|P1|Participant Flow|Closed Incision Wound Vacuum (Prevena)|"Closed incision wound vacuum (Prevena)~Closed incision wound vacuum (Prevena): wound vacuum to be placed on a closed incision"
72527|NCT02128997|O2|Outcome|Routine Wound Care|This arm includes patients having a cesarean section with routine wound care
72528|NCT02128997|O1|Outcome|Closed Incision Wound Vacuum (Prevena)|"Closed incision wound vacuum (Prevena)~Closed incision wound vacuum (Prevena): wound vacuum to be placed on a closed incision"
72529|NCT02128997|O2|Outcome|Routine Wound Care|This arm includes patients having a cesarean section with routine wound care
72530|NCT02128997|O1|Outcome|Closed Incision Wound Vacuum (Prevena)|"Closed incision wound vacuum (Prevena)~Closed incision wound vacuum (Prevena): wound vacuum to be placed on a closed incision"
72531|NCT02128997|O2|Outcome|Routine Wound Care|This arm includes patients having a cesarean section with routine wound care
72532|NCT02128997|O1|Outcome|Closed Incision Wound Vacuum (Prevena)|"Closed incision wound vacuum (Prevena)~Closed incision wound vacuum (Prevena): wound vacuum to be placed on a closed incision"
72533|NCT02128997|O2|Outcome|Routine Wound Care|This arm includes patients having a cesarean section with routine wound care
72534|NCT02128997|O1|Outcome|Closed Incision Wound Vacuum (Prevena)|"Closed incision wound vacuum (Prevena)~Closed incision wound vacuum (Prevena): wound vacuum to be placed on a closed incision"
72535|NCT02128997|E2|Reported Event|Routine Wound Care|This arm includes patients having a cesarean section with routine wound care
72538|NCT02128932|B3|Baseline|Insulin Glargine|Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
72539|NCT02128932|B2|Baseline|Semaglutide 1.0 mg/Week|Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject`s willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
72540|NCT02128932|B1|Baseline|Semaglutide 0.5mg/Week|Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject`s willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
72541|NCT02128932|P3|Participant Flow|Insulin Glargine|Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
72542|NCT02128932|P2|Participant Flow|Semaglutide 1.0 mg/Week|Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject`s willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
72543|NCT02128932|P1|Participant Flow|Semaglutide 0.5mg/Week|Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject`s willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
72544|NCT02128932|O3|Outcome|Insulin Glargine|Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
72545|NCT02128932|O2|Outcome|Semaglutide 1.0 mg/Week|Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject`s willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
72546|NCT02128932|O1|Outcome|Semaglutide 0.5mg/Week|Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject`s willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
72547|NCT02128932|O3|Outcome|Insulin Glargine|Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
72568|NCT02128932|E3|Reported Event|Insulin Glargine|Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
73663|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
72548|NCT02128932|O2|Outcome|Semaglutide 1.0 mg/Week|Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject`s willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
72549|NCT02128932|O1|Outcome|Semaglutide 0.5mg/Week|Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject`s willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
72550|NCT02128932|O3|Outcome|Insulin Glargine|Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
72551|NCT02128932|O2|Outcome|Semaglutide 1.0 mg/Week|Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject`s willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
72552|NCT02128932|O1|Outcome|Semaglutide 0.5mg/Week|Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject`s willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
72553|NCT02128932|O3|Outcome|Insulin Glargine|Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
72554|NCT02128932|O2|Outcome|Semaglutide 1.0 mg/Week|Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject`s willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
72555|NCT02128932|O1|Outcome|Semaglutide 0.5mg/Week|Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject`s willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
72556|NCT02128932|O3|Outcome|Insulin Glargine|Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
72557|NCT02128932|O2|Outcome|Semaglutide 1.0 mg/Week|Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject`s willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
72558|NCT02128932|O1|Outcome|Semaglutide 0.5mg/Week|Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject`s willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
72559|NCT02128932|O3|Outcome|Insulin Glargine|Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
72560|NCT02128932|O2|Outcome|Semaglutide 1.0 mg/Week|Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject`s willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
72561|NCT02128932|O1|Outcome|Semaglutide 0.5mg/Week|Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject`s willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
72562|NCT02128932|O3|Outcome|Insulin Glargine|Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
72563|NCT02128932|O2|Outcome|Semaglutide 1.0 mg/Week|Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject`s willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
72564|NCT02128932|O1|Outcome|Semaglutide 0.5mg/Week|Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject`s willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
72565|NCT02128932|O3|Outcome|Insulin Glargine|Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
72566|NCT02128932|O2|Outcome|Semaglutide 1.0 mg/Week|Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject`s willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
72567|NCT02128932|O1|Outcome|Semaglutide 0.5mg/Week|Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject`s willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
72569|NCT02128932|E2|Reported Event|Semaglutide 1.0 mg/Week|Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject`s willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
72570|NCT02128932|E1|Reported Event|Semaglutide 0.5mg/Week|Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject`s willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
72571|NCT02128919|B3|Baseline|Total|Total of all reporting groups
72572|NCT02128919|B2|Baseline|Sham tDCS|"tDCS 2 ma for 40 second s with anode at DLPFC for 5 days~tDCS: Transcranial Direct Current Stimulation"
72573|NCT02128919|B1|Baseline|Active tDCS|"tDCS 2ma for 20 min with anode at DLPFC once a day for 5 days~tDCS: Transcranial Direct Current Stimulation"
72574|NCT02128919|P2|Participant Flow|Sham tDCS|"tDCS 2 ma for 40 second s with anode at DLPFC for 5 days~tDCS: Transcranial Direct Current Stimulation"
72575|NCT02128919|P1|Participant Flow|Active tDCS|"tDCS 2ma for 20 min with anode at DLPFC once a day for 5 days~tDCS: Transcranial Direct Current Stimulation"
72576|NCT02128919|O2|Outcome|Sham tDCS|"tDCS 2 ma for 40 seconds with anode at DLPFC for 5 days~tDCS: Transcranial Direct Current Stimulation"
72577|NCT02128919|O1|Outcome|Active tDCS|"tDCS 2ma for 20 min with anode at DLPFC once a day for 5 days~tDCS: Transcranial Direct Current Stimulation"
72578|NCT02128919|O2|Outcome|Sham tDCS|"tDCS 2 ma for 40 seconds with anode at DLPFC for 5 days~tDCS: Transcranial Direct Current Stimulation"
72579|NCT02128919|O1|Outcome|Active tDCS|"tDCS 2ma for 20 min with anode at DLPFC once a day for 5 days~tDCS: Transcranial Direct Current Stimulation"
72580|NCT02128919|O2|Outcome|Sham tDCS|"tDCS 2 ma for 40 second s with anode at DLPFC for 5 days~tDCS: Transcranial Direct Current Stimulation"
72581|NCT02128919|O1|Outcome|Active tDCS|"tDCS 2ma for 20 min with anode at DLPFC once a day for 5 days~tDCS: Transcranial Direct Current Stimulation"
72582|NCT02128919|E2|Reported Event|Sham tDCS|"tDCS 2 ma for 40 second s with anode at DLPFC for 5 days~tDCS: Transcranial Direct Current Stimulation"
72583|NCT02128919|E1|Reported Event|Active tDCS|"tDCS 2ma for 20 min with anode at DLPFC once a day for 5 days~tDCS: Transcranial Direct Current Stimulation"
72584|NCT02128867|B4|Baseline|Total|Total of all reporting groups
72585|NCT02128867|B3|Baseline|Bouncing|"bouncing . intervention to relax the infant~bouncing"
72586|NCT02128867|B2|Baseline|Bouncing Combined With AAD|"airway clearance technique for infants : bouncing combined with AAD~bouncing combined with AAD"
72587|NCT02128867|B1|Baseline|Assisted Autogenic Drainage (AAD)|"airway clearance technique for infants :Assisted Autogenic Drainage~Assisted Autogenic Drainage (AAD)"
72588|NCT02128867|P3|Participant Flow|Bouncing|"bouncing as control group. intervention to relax the infant~bouncing"
72589|NCT02128867|P2|Participant Flow|Bouncing Combined With AAD|"airway clearance technique for infants : bouncing combined with AAD~bouncing combined with AAD"
72590|NCT02128867|P1|Participant Flow|Assisted Autogenic Drainage (AAD)|"airway clearance technique for infants :Assisted Autogenic Drainage~Assisted Autogenic Drainage (AAD)"
72591|NCT02128867|O3|Outcome|Bouncing|"bouncing as control group. intervention to relax the infant~bouncing"
72592|NCT02128867|O2|Outcome|Bouncing Combined With AAD|"airway clearance technique for infants : bouncing combined with AAD~bouncing combined with AAD"
72593|NCT02128867|O1|Outcome|Assisted Autogenic Drainage (AAD)|"airway clearance technique for infants :Assisted Autogenic Drainage~Assisted Autogenic Drainage (AAD)"
72594|NCT02128867|E3|Reported Event|Bouncing|"bouncing as control group. intervention to relax the infant~bouncing"
72595|NCT02128867|E2|Reported Event|Bouncing Combined With AAD|"airway clearance technique for infants : bouncing combined with AAD~bouncing combined with AAD"
72596|NCT02128867|E1|Reported Event|Assisted Autogenic Drainage (AAD)|"airway clearance technique for infants :Assisted Autogenic Drainage~Assisted Autogenic Drainage (AAD)"
72597|NCT02128542|B3|Baseline|Total|Total of all reporting groups
72598|NCT02128542|B2|Baseline|SOF+RBV 12 Weeks (TE)|Treatment-experienced participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
72599|NCT02128542|B1|Baseline|SOF+RBV 12 Weeks (TN)|Treatment-naive participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
72600|NCT02128542|P2|Participant Flow|SOF+RBV 12 Weeks (TE)|Treatment-experienced participants received sofosbuvir (Sovaldi®; SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
72601|NCT02128542|P1|Participant Flow|SOF+RBV 12 Weeks (TN)|Treatment-naive (TN) participants received sofosbuvir (Sovaldi®; SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
72602|NCT02128542|O1|Outcome|SOF+RBV 12 Weeks (All)|All participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
72603|NCT02128542|O2|Outcome|SOF+RBV 12 Weeks (TE)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
72604|NCT02128542|O1|Outcome|SOF+RBV 12 Weeks (TN)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
72607|NCT02128542|O2|Outcome|SOF+RBV 12 Weeks (TE)|Treatment-experienced participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
72608|NCT02128542|O1|Outcome|SOF+RBV 12 Weeks (TN)|Treatment-naive participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
72609|NCT02128542|O1|Outcome|SOF+RBV 12 Weeks (All)|All participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
72610|NCT02128542|O2|Outcome|SOF+RBV 12 Weeks (TE)|Treatment-experienced participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
72611|NCT02128542|O1|Outcome|SOF+RBV 12 Weeks (TN)|Treatment-naive participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
72612|NCT02128542|E1|Reported Event|SOF+RBV 12 Weeks (All Participants)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
72613|NCT02128490|B6|Baseline|Total|Total of all reporting groups
72614|NCT02128490|B5|Baseline|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72615|NCT02128490|B4|Baseline|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72616|NCT02128490|B3|Baseline|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72617|NCT02128490|B2|Baseline|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72618|NCT02128490|B1|Baseline|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72619|NCT02128490|P5|Participant Flow|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72620|NCT02128490|P4|Participant Flow|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72621|NCT02128490|P3|Participant Flow|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72622|NCT02128490|P2|Participant Flow|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72623|NCT02128490|P1|Participant Flow|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72624|NCT02128490|O5|Outcome|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72625|NCT02128490|O4|Outcome|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72626|NCT02128490|O3|Outcome|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72627|NCT02128490|O2|Outcome|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72628|NCT02128490|O1|Outcome|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72629|NCT02128490|O5|Outcome|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72630|NCT02128490|O4|Outcome|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72631|NCT02128490|O3|Outcome|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72632|NCT02128490|O2|Outcome|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72633|NCT02128490|O1|Outcome|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72832|NCT02126839|B2|Baseline|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
72634|NCT02128490|O5|Outcome|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72635|NCT02128490|O4|Outcome|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72636|NCT02128490|O3|Outcome|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72637|NCT02128490|O2|Outcome|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72638|NCT02128490|O1|Outcome|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72639|NCT02128490|E5|Reported Event|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72640|NCT02128490|E4|Reported Event|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72641|NCT02128490|E3|Reported Event|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72642|NCT02128490|E2|Reported Event|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72643|NCT02128490|E1|Reported Event|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
72644|NCT02128269|B1|Baseline|ALXN1007- Open Label Study|"ALXN1007~ALXN1007: 10 mg/kg IV q 2 weeks x 12 doses"
72645|NCT02128269|P1|Participant Flow|ALXN1007|ALXN1007 10 mg/kg IV q 2 weeks x 12 doses
72646|NCT02128269|O1|Outcome|ALXN1007|ALXN1007 10 mg/kg IV q 2 weeks x 12 doses
72647|NCT02128269|E1|Reported Event|ALXN1007- Open Label Study|"ALXN1007~ALXN1007: 10 mg/kg IV q 2 weeks x 12 doses"
72648|NCT02128217|B3|Baseline|Total|Total of all reporting groups
72649|NCT02128217|B2|Baseline|Cohort 2: LDV/SOF for 8 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF."
72650|NCT02128217|B1|Baseline|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.~Ribavirin(RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management."
72651|NCT02128217|P2|Participant Flow|Cohort 2: LDV/SOF for 8 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF."
72652|NCT02128217|P1|Participant Flow|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.~Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management."
72653|NCT02128217|O2|Outcome|Cohort 2: LDV/SOF for 8 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF."
72654|NCT02128217|O1|Outcome|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food."
72655|NCT02128217|O2|Outcome|Cohort 2: LDV/SOF for 8 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF."
72656|NCT02128217|O1|Outcome|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food."
76801|NCT02104804|O1|Outcome|Saxagliptin Plus Insulin|Saxagliptin 5 mg plus insulin
72657|NCT02128217|O2|Outcome|Cohort 2: LDV/SOF for 8 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF."
72658|NCT02128217|O1|Outcome|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food."
72659|NCT02128217|O2|Outcome|Cohort 2: LDV/SOF for 8 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF."
72660|NCT02128217|O1|Outcome|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food."
72661|NCT02128217|O2|Outcome|Cohort 2: LDV/SOF for 8 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF."
72662|NCT02128217|O1|Outcome|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.~Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management."
72663|NCT02128217|O2|Outcome|Cohort 2: LDV/SOF for 8 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF."
72664|NCT02128217|O1|Outcome|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.~Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management."
72665|NCT02128217|O2|Outcome|Cohort 2: LDV/SOF for 8 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF."
72666|NCT02128217|O1|Outcome|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.~Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management."
72667|NCT02128217|O2|Outcome|Cohort 2: LDV/SOF for 8 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF."
72668|NCT02128217|O1|Outcome|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.~Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management."
72669|NCT02128217|O2|Outcome|Cohort 2: LDV/SOF for 8 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF."
72670|NCT02128217|O1|Outcome|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food."
72671|NCT02128217|O2|Outcome|Cohort 2: LDV/SOF for 8 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF."
72687|NCT02128217|O2|Outcome|Cohort 2: LDV/SOF for 8 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF."
72830|NCT02127281|E1|Reported Event|Prevena|"Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days).~Prevena: Device will be applied at end of procedure over closed incision."
72672|NCT02128217|O1|Outcome|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.~Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management."
72673|NCT02128217|O2|Outcome|Cohort 2: LDV/SOF for 8 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF."
72674|NCT02128217|O1|Outcome|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.~Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management."
72675|NCT02128217|O2|Outcome|Cohort 2: LDV/SOF for 8 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF."
72676|NCT02128217|O1|Outcome|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.~Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management."
72677|NCT02128217|O2|Outcome|Cohort 2: LDV/SOF for 8 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF."
72678|NCT02128217|O1|Outcome|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.~Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management."
72679|NCT02128217|O2|Outcome|Cohort 2: LDV/SOF for 8 Wks|"Follow-up through to occurred 24 weeks after the end of treatment.~Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF."
72680|NCT02128217|O1|Outcome|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.~Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management."
72681|NCT02128217|O2|Outcome|Cohort 2: LDV/SOF for 8 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF."
72682|NCT02128217|O1|Outcome|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.~Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management."
72683|NCT02128217|O2|Outcome|Cohort 2: LDV/SOF for 8 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF."
72684|NCT02128217|O1|Outcome|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred 24 through to weeks after the end of treatment.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.~Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management."
72685|NCT02128217|O2|Outcome|Cohort 2: LDV/SOF for 8 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF."
72686|NCT02128217|O1|Outcome|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.~Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management."
72831|NCT02126839|B3|Baseline|Total|Total of all reporting groups
72688|NCT02128217|O1|Outcome|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.~Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management."
72689|NCT02128217|O2|Outcome|Cohort 2: LDV/SOF for 8 Wks|"Follow-up occurred through 24 weeks after the end of treatment.~Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF."
72690|NCT02128217|O1|Outcome|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred through 24 weeks after the end of treatment.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.~Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management."
72691|NCT02128217|E2|Reported Event|Cohort 2: LDV/SOF for 8 Wks|Follow-up occurred 24 weeks after the end of treatment. Ledipasvir/Sofosbuvir: Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF.
72692|NCT02128217|E1|Reported Event|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred 24 weeks after the end of treatment. Ribavirin: Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.~Sofosbuvir: Participants received one 400 mg tablet of sofosbuvir orally every morning with food."
72693|NCT02127892|B5|Baseline|Total|Total of all reporting groups
72694|NCT02127892|B4|Baseline|Unrelated PBSC With T Cell Depletion|"The preferred source will be bone marrow, however, if a donor is unable or unwilling to donate bone marrow, peripheral blood stem cells (PBSC) will be allowed.~unrelated PBSC with T cell depletion: peripheral blood stem cell will be processed for CD34+ cell isolation."
72695|NCT02127892|B3|Baseline|Haplo BM With T Cell Depletion|"If there is no unrelated donor available meeting the matching criteria for unrelated bone marrow or unrelated cord blood donors.~haplo BM with T cell depletion: haplo-identical (parental) bone marrow will be processed for CD34+ cell isolation."
72696|NCT02127892|B2|Baseline|Unrelated Cord Blood|"Acceptable matching for unrelated cord blood will be a genotypic match at 6 of 6 alleles (HLA A, B and DR) or 5 of 6 alleles, but not with mismatches at both alleles of a single locus (e.g. not mismatched for both HLA A alleles).~unrelated cord blood: Cord blood will be thawed (and processed if ABO incompatibility) per institutional SOP."
72697|NCT02127892|B1|Baseline|Unrelated BM With T Cell Depletion|"Acceptable matching for matched unrelated donor (MUD) bone marrow will be genotypic matches at 10 of 10 HLA alleles (HLA-A, B, C, DR and DQ) or 9 of 10 HLA alleles.~unrelated BM with T cell depletion: Remaining unmanipulated bone marrow will be processed to isolate CD34+ cells (T cell depleted)."
72698|NCT02127892|P4|Participant Flow|Unrelated PBSC With T Cell Depletion|"The preferred source will be bone marrow, however, if a donor is unable or unwilling to donate bone marrow, peripheral blood stem cells (PBSC) will be allowed.~unrelated PBSC with T cell depletion: peripheral blood stem cell will be processed for CD34+ cell isolation."
72699|NCT02127892|P3|Participant Flow|Haplo BM With T Cell Depletion|"If there is no unrelated donor available meeting the matching criteria for unrelated bone marrow or unrelated cord blood donors.~haplo BM with T cell depletion: haplo-identical (parental) bone marrow will be processed for CD34+ cell isolation."
72700|NCT02127892|P2|Participant Flow|Unrelated Cord Blood|"Acceptable matching for unrelated cord blood will be a genotypic match at 6 of 6 alleles (HLA A, B and DR) or 5 of 6 alleles, but not with mismatches at both alleles of a single locus (e.g. not mismatched for both HLA A alleles).~unrelated cord blood: Cord blood will be thawed (and processed if ABO incompatibility) per institutional SOP."
72701|NCT02127892|P1|Participant Flow|Unrelated BM With T Cell Depletion|"Acceptable matching for matched unrelated donor (MUD) bone marrow will be genotypic matches at 10 of 10 HLA alleles (HLA-A, B, C, DR and DQ) or 9 of 10 HLA alleles.~unrelated BM with T cell depletion: Remaining unmanipulated bone marrow will be processed to isolate CD34+ cells (T cell depleted)."
72702|NCT02127892|O4|Outcome|Unrelated PBSC With T Cell Depletion|"The preferred source will be bone marrow, however, if a donor is unable or unwilling to donate bone marrow, peripheral blood stem cells (PBSC) will be allowed.~unrelated PBSC with T cell depletion: peripheral blood stem cell will be processed for CD34+ cell isolation."
72703|NCT02127892|O3|Outcome|Haplo BM With T Cell Depletion|"If there is no unrelated donor available meeting the matching criteria for unrelated bone marrow or unrelated cord blood donors.~haplo BM with T cell depletion: haplo-identical (parental) bone marrow will be processed for CD34+ cell isolation."
72704|NCT02127892|O2|Outcome|Unrelated Cord Blood|"Acceptable matching for unrelated cord blood will be a genotypic match at 6 of 6 alleles (HLA A, B and DR) or 5 of 6 alleles, but not with mismatches at both alleles of a single locus (e.g. not mismatched for both HLA A alleles).~unrelated cord blood: Cord blood will be thawed (and processed if ABO incompatibility) per institutional SOP."
72705|NCT02127892|O1|Outcome|Unrelated BM With T Cell Depletion|"Acceptable matching for matched unrelated donor (MUD) bone marrow will be genotypic matches at 10 of 10 HLA alleles (HLA-A, B, C, DR and DQ) or 9 of 10 HLA alleles.~unrelated BM with T cell depletion: Remaining unmanipulated bone marrow will be processed to isolate CD34+ cells (T cell depleted)."
72706|NCT02127892|O4|Outcome|Unrelated PBSC With T Cell Depletion|"The preferred source will be bone marrow, however, if a donor is unable or unwilling to donate bone marrow, peripheral blood stem cells (PBSC) will be allowed.~unrelated PBSC with T cell depletion: peripheral blood stem cell will be processed for CD34+ cell isolation."
72824|NCT02127281|O1|Outcome|Prevena|"Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days).~Prevena: Device will be applied at end of procedure over closed incision."
72707|NCT02127892|O3|Outcome|Haplo BM With T Cell Depletion|"If there is no unrelated donor available meeting the matching criteria for unrelated bone marrow or unrelated cord blood donors.~haplo BM with T cell depletion: haplo-identical (parental) bone marrow will be processed for CD34+ cell isolation."
72708|NCT02127892|O2|Outcome|Unrelated Cord Blood|"Acceptable matching for unrelated cord blood will be a genotypic match at 6 of 6 alleles (HLA A, B and DR) or 5 of 6 alleles, but not with mismatches at both alleles of a single locus (e.g. not mismatched for both HLA A alleles).~unrelated cord blood: Cord blood will be thawed (and processed if ABO incompatibility) per institutional SOP."
72709|NCT02127892|O1|Outcome|Unrelated BM With T Cell Depletion|"Acceptable matching for matched unrelated donor (MUD) bone marrow will be genotypic matches at 10 of 10 HLA alleles (HLA-A, B, C, DR and DQ) or 9 of 10 HLA alleles.~unrelated BM with T cell depletion: Remaining unmanipulated bone marrow will be processed to isolate CD34+ cells (T cell depleted)."
72710|NCT02127892|O4|Outcome|Unrelated PBSC With T Cell Depletion|"The preferred source will be bone marrow, however, if a donor is unable or unwilling to donate bone marrow, peripheral blood stem cells (PBSC) will be allowed.~unrelated PBSC with T cell depletion: peripheral blood stem cell will be processed for CD34+ cell isolation."
72711|NCT02127892|O3|Outcome|Haplo BM With T Cell Depletion|"If there is no unrelated donor available meeting the matching criteria for unrelated bone marrow or unrelated cord blood donors.~haplo BM with T cell depletion: haplo-identical (parental) bone marrow will be processed for CD34+ cell isolation."
72712|NCT02127892|O2|Outcome|Unrelated Cord Blood|"Acceptable matching for unrelated cord blood will be a genotypic match at 6 of 6 alleles (HLA A, B and DR) or 5 of 6 alleles, but not with mismatches at both alleles of a single locus (e.g. not mismatched for both HLA A alleles).~unrelated cord blood: Cord blood will be thawed (and processed if ABO incompatibility) per institutional SOP."
72713|NCT02127892|O1|Outcome|Unrelated BM With T Cell Depletion|"Acceptable matching for matched unrelated donor (MUD) bone marrow will be genotypic matches at 10 of 10 HLA alleles (HLA-A, B, C, DR and DQ) or 9 of 10 HLA alleles.~unrelated BM with T cell depletion: Remaining unmanipulated bone marrow will be processed to isolate CD34+ cells (T cell depleted)."
72714|NCT02127892|O4|Outcome|Unrelated PBSC With T Cell Depletion|"The preferred source will be bone marrow, however, if a donor is unable or unwilling to donate bone marrow, peripheral blood stem cells (PBSC) will be allowed.~unrelated PBSC with T cell depletion: peripheral blood stem cell will be processed for CD34+ cell isolation."
72715|NCT02127892|O3|Outcome|Haplo BM With T Cell Depletion|"If there is no unrelated donor available meeting the matching criteria for unrelated bone marrow or unrelated cord blood donors.~haplo BM with T cell depletion: haplo-identical (parental) bone marrow will be processed for CD34+ cell isolation."
72716|NCT02127892|O2|Outcome|Unrelated Cord Blood|"Acceptable matching for unrelated cord blood will be a genotypic match at 6 of 6 alleles (HLA A, B and DR) or 5 of 6 alleles, but not with mismatches at both alleles of a single locus (e.g. not mismatched for both HLA A alleles).~unrelated cord blood: Cord blood will be thawed (and processed if ABO incompatibility) per institutional SOP."
72717|NCT02127892|O1|Outcome|Unrelated BM With T Cell Depletion|"Acceptable matching for matched unrelated donor (MUD) bone marrow will be genotypic matches at 10 of 10 HLA alleles (HLA-A, B, C, DR and DQ) or 9 of 10 HLA alleles.~unrelated BM with T cell depletion: Remaining unmanipulated bone marrow will be processed to isolate CD34+ cells (T cell depleted)."
72718|NCT02127892|O4|Outcome|Unrelated PBSC With T Cell Depletion|"The preferred source will be bone marrow, however, if a donor is unable or unwilling to donate bone marrow, peripheral blood stem cells (PBSC) will be allowed.~unrelated PBSC with T cell depletion: peripheral blood stem cell will be processed for CD34+ cell isolation."
72719|NCT02127892|O3|Outcome|Haplo BM With T Cell Depletion|"If there is no unrelated donor available meeting the matching criteria for unrelated bone marrow or unrelated cord blood donors.~haplo BM with T cell depletion: haplo-identical (parental) bone marrow will be processed for CD34+ cell isolation."
72720|NCT02127892|O2|Outcome|Unrelated Cord Blood|"Acceptable matching for unrelated cord blood will be a genotypic match at 6 of 6 alleles (HLA A, B and DR) or 5 of 6 alleles, but not with mismatches at both alleles of a single locus (e.g. not mismatched for both HLA A alleles).~unrelated cord blood: Cord blood will be thawed (and processed if ABO incompatibility) per institutional SOP."
72721|NCT02127892|O1|Outcome|Unrelated BM With T Cell Depletion|"Acceptable matching for matched unrelated donor (MUD) bone marrow will be genotypic matches at 10 of 10 HLA alleles (HLA-A, B, C, DR and DQ) or 9 of 10 HLA alleles.~unrelated BM with T cell depletion: Remaining unmanipulated bone marrow will be processed to isolate CD34+ cells (T cell depleted)."
72722|NCT02127892|E4|Reported Event|Unrelated PBSC With T Cell Depletion|"The preferred source will be bone marrow, however, if a donor is unable or unwilling to donate bone marrow, peripheral blood stem cells (PBSC) will be allowed.~unrelated PBSC with T cell depletion: peripheral blood stem cell will be processed for CD34+ cell isolation."
72723|NCT02127892|E3|Reported Event|Haplo BM With T Cell Depletion|"If there is no unrelated donor available meeting the matching criteria for unrelated bone marrow or unrelated cord blood donors.~haplo BM with T cell depletion: haplo-identical (parental) bone marrow will be processed for CD34+ cell isolation."
72724|NCT02127892|E2|Reported Event|Unrelated Cord Blood|"Acceptable matching for unrelated cord blood will be a genotypic match at 6 of 6 alleles (HLA A, B and DR) or 5 of 6 alleles, but not with mismatches at both alleles of a single locus (e.g. not mismatched for both HLA A alleles).~unrelated cord blood: Cord blood will be thawed (and processed if ABO incompatibility) per institutional SOP."
72725|NCT02127892|E1|Reported Event|Unrelated BM With T Cell Depletion|"Acceptable matching for matched unrelated donor (MUD) bone marrow will be genotypic matches at 10 of 10 HLA alleles (HLA-A, B, C, DR and DQ) or 9 of 10 HLA alleles.~unrelated BM with T cell depletion: Remaining unmanipulated bone marrow will be processed to isolate CD34+ cells (T cell depleted)."
72726|NCT02127710|B4|Baseline|Total|Total of all reporting groups
72727|NCT02127710|B3|Baseline|c-MET Status Unknown|"Papillary renal cell carcinoma (PRCC) is divided into two subtypes based upon histological criteria and distinctive gene expression profile: type I (hereditary papillary renal carcinoma [HPRC]) and type II. In HPRC, mutations in the gene encoding the receptor for Hepatocyte Growth Factor (HGF), MET, are associated with the onset of multiple bilateral type I papillary carcinomas; these tumors tend to be low grade and have a better prognosis. Type II lesions are generally high grade and have a poorer prognosis.~All participants were tested for the presence of c-MET mutations."
72825|NCT02127281|O2|Outcome|Control|A standard of care sterile wound dressing will be placed.
72728|NCT02127710|B2|Baseline|c-MET Negative|"Papillary renal cell carcinoma (PRCC) is divided into two subtypes based upon histological criteria and distinctive gene expression profile: type I (hereditary papillary renal carcinoma [HPRC]) and type II. In HPRC, mutations in the gene encoding the receptor for Hepatocyte Growth Factor (HGF), MET, are associated with the onset of multiple bilateral type I papillary carcinomas; these tumors tend to be low grade and have a better prognosis. Type II lesions are generally high grade and have a poorer prognosis.~All participants were tested for the presence of c-MET mutations."
72729|NCT02127710|B1|Baseline|c-MET Positive|"Papillary renal cell carcinoma (PRCC) is divided into two subtypes based upon histological criteria and distinctive gene expression profile: type I (hereditary papillary renal carcinoma [HPRC]) and type II. In HPRC, mutations in the gene encoding the receptor for Hepatocyte Growth Factor (HGF), MET, are associated with the onset of multiple bilateral type I papillary carcinomas; these tumors tend to be low grade and have a better prognosis. Type II lesions are generally high grade and have a poorer prognosis.~All participants were tested for the presence of c-MET mutations."
72730|NCT02127710|P3|Participant Flow|c-MET Status Unknown|"Papillary renal cell carcinoma (PRCC) is divided into two subtypes based upon histological criteria and distinctive gene expression profile: type I (hereditary papillary renal carcinoma [HPRC]) and type II. In HPRC, mutations in the gene encoding the receptor for Hepatocyte Growth Factor (HGF), MET, are associated with the onset of multiple bilateral type I papillary carcinomas; these tumors tend to be low grade and have a better prognosis. Type II lesions are generally high grade and have a poorer prognosis.~All participants were tested for the presence of c-MET mutations."
72731|NCT02127710|P2|Participant Flow|c-MET Negative|"Papillary renal cell carcinoma (PRCC) is divided into two subtypes based upon histological criteria and distinctive gene expression profile: type I (hereditary papillary renal carcinoma [HPRC]) and type II. In HPRC, mutations in the gene encoding the receptor for Hepatocyte Growth Factor (HGF), MET, are associated with the onset of multiple bilateral type I papillary carcinomas; these tumors tend to be low grade and have a better prognosis. Type II lesions are generally high grade and have a poorer prognosis.~All participants were tested for the presence of c-MET mutations."
72732|NCT02127710|P1|Participant Flow|c-MET Positive|"Papillary renal cell carcinoma (PRCC) is divided into two subtypes based upon histological criteria and distinctive gene expression profile: type I (hereditary papillary renal carcinoma [HPRC]) and type II. In HPRC, mutations in the gene encoding the receptor for Hepatocyte Growth Factor (HGF), MET, are associated with the onset of multiple bilateral type I papillary carcinomas; these tumors tend to be low grade and have a better prognosis. Type II lesions are generally high grade and have a poorer prognosis.~All participants were tested for the presence of c-MET mutations."
72733|NCT02127710|O3|Outcome|c-MET Status Unknown|"Papillary renal cell carcinoma (PRCC) is divided into two subtypes based upon histological criteria and distinctive gene expression profile: type I (hereditary papillary renal carcinoma [HPRC]) and type II. In HPRC, mutations in the gene encoding the receptor for Hepatocyte Growth Factor (HGF), MET, are associated with the onset of multiple bilateral type I papillary carcinomas; these tumors tend to be low grade and have a better prognosis. Type II lesions are generally high grade and have a poorer prognosis.~All participants were tested for the presence of c-MET mutations."
72734|NCT02127710|O2|Outcome|c-MET Negative|"Papillary renal cell carcinoma (PRCC) is divided into two subtypes based upon histological criteria and distinctive gene expression profile: type I (hereditary papillary renal carcinoma [HPRC]) and type II. In HPRC, mutations in the gene encoding the receptor for Hepatocyte Growth Factor (HGF), MET, are associated with the onset of multiple bilateral type I papillary carcinomas; these tumors tend to be low grade and have a better prognosis. Type II lesions are generally high grade and have a poorer prognosis.~All participants were tested for the presence of c-MET mutations."
72735|NCT02127710|O1|Outcome|c-MET Positive|"Papillary renal cell carcinoma (PRCC) is divided into two subtypes based upon histological criteria and distinctive gene expression profile: type I (hereditary papillary renal carcinoma [HPRC]) and type II. In HPRC, mutations in the gene encoding the receptor for Hepatocyte Growth Factor (HGF), MET, are associated with the onset of multiple bilateral type I papillary carcinomas; these tumors tend to be low grade and have a better prognosis. Type II lesions are generally high grade and have a poorer prognosis.~All participants were tested for the presence of c-MET mutations."
72736|NCT02127710|O3|Outcome|c-MET Status Unknown|"Papillary renal cell carcinoma (PRCC) is divided into two subtypes based upon histological criteria and distinctive gene expression profile: type I (hereditary papillary renal carcinoma [HPRC]) and type II. In HPRC, mutations in the gene encoding the receptor for Hepatocyte Growth Factor (HGF), MET, are associated with the onset of multiple bilateral type I papillary carcinomas; these tumors tend to be low grade and have a better prognosis. Type II lesions are generally high grade and have a poorer prognosis.~All participants were tested for the presence of c-MET mutations."
72737|NCT02127710|O2|Outcome|c-MET Negative|"Papillary renal cell carcinoma (PRCC) is divided into two subtypes based upon histological criteria and distinctive gene expression profile: type I (hereditary papillary renal carcinoma [HPRC]) and type II. In HPRC, mutations in the gene encoding the receptor for Hepatocyte Growth Factor (HGF), MET, are associated with the onset of multiple bilateral type I papillary carcinomas; these tumors tend to be low grade and have a better prognosis. Type II lesions are generally high grade and have a poorer prognosis.~All participants were tested for the presence of c-MET mutations."
72738|NCT02127710|O1|Outcome|c-MET Positive|"Papillary renal cell carcinoma (PRCC) is divided into two subtypes based upon histological criteria and distinctive gene expression profile: type I (hereditary papillary renal carcinoma [HPRC]) and type II. In HPRC, mutations in the gene encoding the receptor for Hepatocyte Growth Factor (HGF), MET, are associated with the onset of multiple bilateral type I papillary carcinomas; these tumors tend to be low grade and have a better prognosis. Type II lesions are generally high grade and have a poorer prognosis.~All participants were tested for the presence of c-MET mutations."
72739|NCT02127710|O3|Outcome|c-MET Status Unknown|"Papillary renal cell carcinoma (PRCC) is divided into two subtypes based upon histological criteria and distinctive gene expression profile: type I (hereditary papillary renal carcinoma [HPRC]) and type II. In HPRC, mutations in the gene encoding the receptor for Hepatocyte Growth Factor (HGF), MET, are associated with the onset of multiple bilateral type I papillary carcinomas; these tumors tend to be low grade and have a better prognosis. Type II lesions are generally high grade and have a poorer prognosis.~All participants were tested for the presence of c-MET mutations."
72874|NCT02126670|E4|Reported Event|ACT01 Plus Comp04|"ACT01 Cream in combination with Comp04 Cream, once daily, 29 days~ACT01~Comp04"
72740|NCT02127710|O2|Outcome|c-MET Negative|"Papillary renal cell carcinoma (PRCC) is divided into two subtypes based upon histological criteria and distinctive gene expression profile: type I (hereditary papillary renal carcinoma [HPRC]) and type II. In HPRC, mutations in the gene encoding the receptor for Hepatocyte Growth Factor (HGF), MET, are associated with the onset of multiple bilateral type I papillary carcinomas; these tumors tend to be low grade and have a better prognosis. Type II lesions are generally high grade and have a poorer prognosis.~All participants were tested for the presence of c-MET mutations."
72741|NCT02127710|O1|Outcome|c-MET Positive|"Papillary renal cell carcinoma (PRCC) is divided into two subtypes based upon histological criteria and distinctive gene expression profile: type I (hereditary papillary renal carcinoma [HPRC]) and type II. In HPRC, mutations in the gene encoding the receptor for Hepatocyte Growth Factor (HGF), MET, are associated with the onset of multiple bilateral type I papillary carcinomas; these tumors tend to be low grade and have a better prognosis. Type II lesions are generally high grade and have a poorer prognosis.~All participants were tested for the presence of c-MET mutations."
72742|NCT02127710|O3|Outcome|c-MET Status Unknown|"Papillary renal cell carcinoma (PRCC) is divided into two subtypes based upon histological criteria and distinctive gene expression profile: type I (hereditary papillary renal carcinoma [HPRC]) and type II. In HPRC, mutations in the gene encoding the receptor for Hepatocyte Growth Factor (HGF), MET, are associated with the onset of multiple bilateral type I papillary carcinomas; these tumors tend to be low grade and have a better prognosis. Type II lesions are generally high grade and have a poorer prognosis.~All participants were tested for the presence of c-MET mutations."
72743|NCT02127710|O2|Outcome|c-MET Negative|"Papillary renal cell carcinoma (PRCC) is divided into two subtypes based upon histological criteria and distinctive gene expression profile: type I (hereditary papillary renal carcinoma [HPRC]) and type II. In HPRC, mutations in the gene encoding the receptor for Hepatocyte Growth Factor (HGF), MET, are associated with the onset of multiple bilateral type I papillary carcinomas; these tumors tend to be low grade and have a better prognosis. Type II lesions are generally high grade and have a poorer prognosis.~All participants were tested for the presence of c-MET mutations."
72744|NCT02127710|O1|Outcome|c-MET Positive|"Papillary renal cell carcinoma (PRCC) is divided into two subtypes based upon histological criteria and distinctive gene expression profile: type I (hereditary papillary renal carcinoma [HPRC]) and type II. In HPRC, mutations in the gene encoding the receptor for Hepatocyte Growth Factor (HGF), MET, are associated with the onset of multiple bilateral type I papillary carcinomas; these tumors tend to be low grade and have a better prognosis. Type II lesions are generally high grade and have a poorer prognosis.~All participants were tested for the presence of c-MET mutations."
72745|NCT02127710|O3|Outcome|c-MET Status Unknown|"Papillary renal cell carcinoma (PRCC) is divided into two subtypes based upon histological criteria and distinctive gene expression profile: type I (hereditary papillary renal carcinoma [HPRC]) and type II. In HPRC, mutations in the gene encoding the receptor for Hepatocyte Growth Factor (HGF), MET, are associated with the onset of multiple bilateral type I papillary carcinomas; these tumors tend to be low grade and have a better prognosis. Type II lesions are generally high grade and have a poorer prognosis.~All participants were tested for the presence of c-MET mutations."
72746|NCT02127710|O2|Outcome|c-MET Negative|"Papillary renal cell carcinoma (PRCC) is divided into two subtypes based upon histological criteria and distinctive gene expression profile: type I (hereditary papillary renal carcinoma [HPRC]) and type II. In HPRC, mutations in the gene encoding the receptor for Hepatocyte Growth Factor (HGF), MET, are associated with the onset of multiple bilateral type I papillary carcinomas; these tumors tend to be low grade and have a better prognosis. Type II lesions are generally high grade and have a poorer prognosis.~All participants were tested for the presence of c-MET mutations."
72747|NCT02127710|O1|Outcome|c-MET Positive|"Papillary renal cell carcinoma (PRCC) is divided into two subtypes based upon histological criteria and distinctive gene expression profile: type I (hereditary papillary renal carcinoma [HPRC]) and type II. In HPRC, mutations in the gene encoding the receptor for Hepatocyte Growth Factor (HGF), MET, are associated with the onset of multiple bilateral type I papillary carcinomas; these tumors tend to be low grade and have a better prognosis. Type II lesions are generally high grade and have a poorer prognosis.~All participants were tested for the presence of c-MET mutations."
72748|NCT02127710|O3|Outcome|c-MET Status Unknown|"Papillary renal cell carcinoma (PRCC) is divided into two subtypes based upon histological criteria and distinctive gene expression profile: type I (hereditary papillary renal carcinoma [HPRC]) and type II. In HPRC, mutations in the gene encoding the receptor for Hepatocyte Growth Factor (HGF), MET, are associated with the onset of multiple bilateral type I papillary carcinomas; these tumors tend to be low grade and have a better prognosis. Type II lesions are generally high grade and have a poorer prognosis.~All participants were tested for the presence of c-MET mutations."
72749|NCT02127710|O2|Outcome|c-MET Negative|"Papillary renal cell carcinoma (PRCC) is divided into two subtypes based upon histological criteria and distinctive gene expression profile: type I (hereditary papillary renal carcinoma [HPRC]) and type II. In HPRC, mutations in the gene encoding the receptor for Hepatocyte Growth Factor (HGF), MET, are associated with the onset of multiple bilateral type I papillary carcinomas; these tumors tend to be low grade and have a better prognosis. Type II lesions are generally high grade and have a poorer prognosis.~All participants were tested for the presence of c-MET mutations."
72750|NCT02127710|O1|Outcome|c-MET Positive|"Papillary renal cell carcinoma (PRCC) is divided into two subtypes based upon histological criteria and distinctive gene expression profile: type I (hereditary papillary renal carcinoma [HPRC]) and type II. In HPRC, mutations in the gene encoding the receptor for Hepatocyte Growth Factor (HGF), MET, are associated with the onset of multiple bilateral type I papillary carcinomas; these tumors tend to be low grade and have a better prognosis. Type II lesions are generally high grade and have a poorer prognosis.~All participants were tested for the presence of c-MET mutations."
72751|NCT02127710|E1|Reported Event|AZD6094 600 mg Per Day Orally|
72752|NCT02127632|B3|Baseline|Total|Total of all reporting groups
72753|NCT02127632|B2|Baseline|Group LM-S(Laryngeal Mask Supreme Group)|"Experimental: Group LM-S Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Endotracheal Tube: ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482"
72826|NCT02127281|O1|Outcome|Prevena|"Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days).~Prevena: Device will be applied at end of procedure over closed incision."
72754|NCT02127632|B1|Baseline|Group ETT (Endo Tracheal Tube)|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Laryngeal Mask Airway-Supreme: Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based K-YTM gel (Johnson & Johnson Ltd. Maidenhead, UK) without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted.~Other Names:~LM-S (The Laryngeal Mask Company Limited, Singapore) serial number: 175030 lot: hmabw7"
72755|NCT02127632|P2|Participant Flow|Group LM-S(Laryngeal Mask Supreme Group)|"Experimental: Group LM-S Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Endotracheal Tube: ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482"
72756|NCT02127632|P1|Participant Flow|Group ETT (Endo Tracheal Tube)|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Laryngeal Mask Airway-Supreme: Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted.~Other Names:~LM-S (The Laryngeal Mask Company Limited, Singapore) serial number: 175030 lot: hmabw7"
72757|NCT02127632|O2|Outcome|Group LM-S(Laryngeal Mask Supreme Group)|"Experimental: Group LM-S Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Endotracheal Tube: ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482"
72758|NCT02127632|O1|Outcome|Group ETT (Endo Tracheal Tube)|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Laryngeal Mask Airway-Supreme: Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based K-YTM gel (Johnson & Johnson Ltd. Maidenhead, UK) without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted.~Other Names:~LM-S (The Laryngeal Mask Company Limited, Singapore) serial number: 175030 lot: hmabw7"
72759|NCT02127632|O2|Outcome|Group LM-S(Laryngeal Mask Supreme Group)|"Experimental: Group LM-S Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Endotracheal Tube: ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482"
72760|NCT02127632|O1|Outcome|Group ETT (Endo Tracheal Tube)|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Laryngeal Mask Airway-Supreme: Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based K-YTM gel (Johnson & Johnson Ltd. Maidenhead, UK) without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted.~Other Names:~LM-S (The Laryngeal Mask Company Limited, Singapore) serial number: 175030 lot: hmabw7"
72761|NCT02127632|O2|Outcome|Group LM-S(Laryngeal Mask Supreme Group)|"Experimental: Group LM-S Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Endotracheal Tube: ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482"
72762|NCT02127632|O1|Outcome|Group ETT (Endo Tracheal Tube)|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Laryngeal Mask Airway-Supreme: Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based K-YTM gel (Johnson & Johnson Ltd. Maidenhead, UK) without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted.~Other Names:~LM-S (The Laryngeal Mask Company Limited, Singapore) serial number: 175030 lot: hmabw7"
72763|NCT02127632|E2|Reported Event|Group LM-S(Laryngeal Mask Supreme Group)|"Experimental: Group LM-S Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Endotracheal Tube: ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482"
72764|NCT02127632|E1|Reported Event|Group ETT (Endo Tracheal Tube)|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Laryngeal Mask Airway-Supreme: Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based K-YTM gel (Johnson & Johnson Ltd. Maidenhead, UK) without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted.~Other Names:~LM-S (The Laryngeal Mask Company Limited, Singapore) serial number: 175030 lot: hmabw7"
72765|NCT02127567|B1|Baseline|All Participants|
72766|NCT02127567|P1|Participant Flow|All Participants|"All participants were asked to write the six parts or 'domains' of the methods section describing a randomized controlled trial. Each participant completed 3 parts or 'domains' with the tool and 3 without.~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
72767|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
72827|NCT02127281|O2|Outcome|Control|A standard of care sterile wound dressing will be placed.
72768|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
72769|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
72770|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
72771|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
72772|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
72773|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
72774|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
72775|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
72776|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
72777|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
72778|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
72828|NCT02127281|O1|Outcome|Prevena|"Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days).~Prevena: Device will be applied at end of procedure over closed incision."
72779|NCT02127567|O2|Outcome|Writing With no Specific Support.|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
72780|NCT02127567|O1|Outcome|Online Writing Tool|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
72781|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
72782|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
72783|NCT02127567|E2|Reported Event|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
72784|NCT02127567|E1|Reported Event|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
72785|NCT02127372|B3|Baseline|Total|Total of all reporting groups
72786|NCT02127372|B2|Baseline|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
72787|NCT02127372|B1|Baseline|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
72788|NCT02127372|P2|Participant Flow|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
72789|NCT02127372|P1|Participant Flow|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
72790|NCT02127372|O1|Outcome|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
72791|NCT02127372|O2|Outcome|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
72792|NCT02127372|O1|Outcome|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
72793|NCT02127372|O1|Outcome|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
72794|NCT02127372|O1|Outcome|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
72795|NCT02127372|O1|Outcome|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
72796|NCT02127372|E2|Reported Event|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
72797|NCT02127372|E1|Reported Event|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
72798|NCT02127307|B1|Baseline|AdreView™- Heart Failure Group|HF participants who were administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were observed to identify who died during 60 months of follow-up at 6-month intervals from the date of administration of 123I-mIBG.
72799|NCT02127307|P1|Participant Flow|AdreView™- Heart Failure Group|HF participants who were administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were observed to identify who died during 60 months of follow-up at 6-month intervals from the date of administration of 123I-mIBG.
72800|NCT02127307|O1|Outcome|AdreView™- Heart Failure Group|HF participants who were administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were observed to identify who died during 60 months of follow-up at 6-month intervals from the date of administration of 123I-mIBG.
72801|NCT02127307|E1|Reported Event|AdreView™- Heart Failure Group|HF participants who were administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were observed to identify who died during 60 months of follow-up at 6-month intervals from the date of administration of 123I-mIBG.
72802|NCT02127281|B3|Baseline|Total|Total of all reporting groups
72803|NCT02127281|B2|Baseline|Control|A standard of care sterile wound dressing will be placed.
72804|NCT02127281|B1|Baseline|Prevena|"Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days).~Prevena: Device will be applied at end of procedure over closed incision."
72805|NCT02127281|P2|Participant Flow|Control|A standard of care sterile wound dressing will be placed.
72806|NCT02127281|P1|Participant Flow|Prevena|"Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days).~Prevena: Device will be applied at end of procedure over closed incision."
72807|NCT02127281|O2|Outcome|Control|A standard of care sterile wound dressing will be placed.
72808|NCT02127281|O1|Outcome|Prevena|"Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days).~Prevena: Device will be applied at end of procedure over closed incision."
72809|NCT02127281|O2|Outcome|Control|A standard of care sterile wound dressing will be placed.
72810|NCT02127281|O1|Outcome|Prevena|"Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days).~Prevena: Device will be applied at end of procedure over closed incision."
72811|NCT02127281|O2|Outcome|Control|A standard of care sterile wound dressing will be placed.
72812|NCT02127281|O1|Outcome|Prevena|"Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days).~Prevena: Device will be applied at end of procedure over closed incision."
72813|NCT02127281|O2|Outcome|Control|A standard of care sterile wound dressing will be placed.
72814|NCT02127281|O1|Outcome|Prevena|"Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days).~Prevena: Device will be applied at end of procedure over closed incision."
72815|NCT02127281|O2|Outcome|Control|A standard of care sterile wound dressing will be placed.
72816|NCT02127281|O1|Outcome|Prevena|"Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days).~Prevena: Device will be applied at end of procedure over closed incision."
72817|NCT02127281|O2|Outcome|Control|A standard of care sterile wound dressing will be placed.
72818|NCT02127281|O1|Outcome|Prevena|"Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days).~Prevena: Device will be applied at end of procedure over closed incision."
72819|NCT02127281|O2|Outcome|Control|A standard of care sterile wound dressing will be placed.
72820|NCT02127281|O1|Outcome|Prevena|"Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days).~Prevena: Device will be applied at end of procedure over closed incision."
72821|NCT02127281|O2|Outcome|Control|A standard of care sterile wound dressing will be placed.
72822|NCT02127281|O1|Outcome|Prevena|"Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days).~Prevena: Device will be applied at end of procedure over closed incision."
72823|NCT02127281|O2|Outcome|Control|A standard of care sterile wound dressing will be placed.
72829|NCT02127281|E2|Reported Event|Control|A standard of care sterile wound dressing will be placed.
72833|NCT02126839|B1|Baseline|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
72834|NCT02126839|P2|Participant Flow|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
72835|NCT02126839|P1|Participant Flow|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
72836|NCT02126839|O2|Outcome|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
72837|NCT02126839|O1|Outcome|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
72838|NCT02126839|O2|Outcome|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
72839|NCT02126839|O1|Outcome|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
72840|NCT02126839|O2|Outcome|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
72841|NCT02126839|O1|Outcome|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
72842|NCT02126839|E2|Reported Event|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
72843|NCT02126839|E1|Reported Event|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
72844|NCT02126748|B4|Baseline|Total|Total of all reporting groups
72845|NCT02126748|B3|Baseline|Control|20 min of bouncing administered tot the patient inhalation 4ml hypertonic saline 3% 3x/day
72846|NCT02126748|B2|Baseline|Assisted Autogenic Drainage|20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
72847|NCT02126748|B1|Baseline|Intrapulmonary Percussive Ventilation|20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
72848|NCT02126748|P3|Participant Flow|Control|20 min of bouncing administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
72849|NCT02126748|P2|Participant Flow|Assisted Autogenic Drainage|"20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day~inhalation 4ml hypertonic saline 3% 3x/day~Assisted Autogenic Drainage"
72850|NCT02126748|P1|Participant Flow|Intrapulmonary Percussive Ventilation|"20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day~inhalation 4ml hypertonic saline 3% 3x/day~Intrapulmonary Percussive Ventilation"
72851|NCT02126748|O3|Outcome|Control|20 min of bouncing administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
72852|NCT02126748|O2|Outcome|Assisted Autogenic Drainage|"20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day~inhalation 4ml hypertonic saline 3% 3x/day~Assisted Autogenic Drainage"
72853|NCT02126748|O1|Outcome|Intrapulmonary Percussive Ventilation|"20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day~inhalation 4ml hypertonic saline 3% 3x/day~Intrapulmonary Percussive Ventilation"
72854|NCT02126748|E3|Reported Event|Control|20 min of bouncing administered tot the patient inhalation 4ml hypertonic saline 3% 3x/day
72855|NCT02126748|E2|Reported Event|Assisted Autogenic Drainage|"20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day~inhalation 4ml hypertonic saline 3% 3x/day~Assisted Autogenic Drainage"
72856|NCT02126748|E1|Reported Event|Intrapulmonary Percussive Ventilation|"20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day~inhalation 4ml hypertonic saline 3% 3x/day~Intrapulmonary Percussive Ventilation"
72857|NCT02126670|B5|Baseline|Total|Total of all reporting groups
72858|NCT02126670|B4|Baseline|ACT01 Plus Comp04|"ACT01 Cream in combination with Comp04 Cream, once daily, 29 days~ACT01~Comp04"
72859|NCT02126670|B3|Baseline|ACT01 Plus Comp03|"ACT01 Cream in combination with Comp03 Cream, once daily, 29 days~ACT01~Comp03"
72860|NCT02126670|B2|Baseline|ACT01 Plus Comp02|"ACT01 Cream in combination with Comp02 Cream, once daily, 29 days~ACT01~Comp02"
72861|NCT02126670|B1|Baseline|ACT01 Plus Comp01|"ACT01 Cream in combination with Comp01 Cream, once daily, 29 days~ACT01~Comp01"
72862|NCT02126670|P4|Participant Flow|ACT01 Plus Comp04|"ACT01 Cream in combination with Comp04 Cream, once daily, 29 days~ACT01~Comp04"
72863|NCT02126670|P3|Participant Flow|ACT01 Plus Comp03|"ACT01 Cream in combination with Comp03 Cream, once daily, 29 days~ACT01~Comp03"
72864|NCT02126670|P2|Participant Flow|ACT01 Plus Comp02|"ACT01 Cream in combination with Comp02 Cream, once daily, 29 days~ACT01~Comp02"
72865|NCT02126670|P1|Participant Flow|ACT01 Plus Comp01|"ACT01 Cream in combination with Comp01 Cream, once daily, 29 days~ACT01~Comp01"
72866|NCT02126670|O4|Outcome|ACT01 Plus Comp04|"ACT01 Cream in combination with Comp04 Cream, once daily, 29 days~ACT01~Comp04"
72867|NCT02126670|O3|Outcome|ACT01 Plus Comp03|"ACT01 Cream in combination with Comp03 Cream, once daily, 29 days~ACT01~Comp03"
72868|NCT02126670|O2|Outcome|ACT01 Plus Comp02|"ACT01 Cream in combination with Comp02 Cream, once daily, 29 days~ACT01~Comp02"
72869|NCT02126670|O1|Outcome|ACT01 Plus Comp01|"ACT01 Cream in combination with Comp01 Cream, once daily, 29 days~ACT01~Comp01"
72870|NCT02126670|O4|Outcome|ACT01 Plus Comp04|"ACT01 Cream in combination with Comp04 Cream, once daily, 29 days~ACT01~Comp04"
72871|NCT02126670|O3|Outcome|ACT01 Plus Comp03|"ACT01 Cream in combination with Comp03 Cream, once daily, 29 days~ACT01~Comp03"
72872|NCT02126670|O2|Outcome|ACT01 Plus Comp02|"ACT01 Cream in combination with Comp02 Cream, once daily, 29 days~ACT01~Comp02"
72873|NCT02126670|O1|Outcome|ACT01 Plus Comp01|"ACT01 Cream in combination with Comp01 Cream, once daily, 29 days~ACT01~Comp01"
72879|NCT02126319|B2|Baseline|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
72880|NCT02126319|B1|Baseline|Cognitive Affective Preparation|Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (“pre-live”) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
72881|NCT02126319|P2|Participant Flow|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
72882|NCT02126319|P1|Participant Flow|Cognitive Affective Preparation|Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (“pre-live”) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
72883|NCT02126319|O2|Outcome|General Health Education|General Health Education: A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
72884|NCT02126319|O1|Outcome|Cognitive Affective Preparation|"Cognitive Affective preparation: Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (pre-live) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)"
72885|NCT02126319|O2|Outcome|General Health Education|General Health Education: A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
72886|NCT02126319|O1|Outcome|Cognitive Affective Preparation|"Cognitive Affective preparation: Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (pre-live) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)"
72887|NCT02126319|O2|Outcome|General Health Education|General Health Education: A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
72888|NCT02126319|O1|Outcome|Cognitive Affective Preparation|"Cognitive Affective preparation: Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (pre-live) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)"
72889|NCT02126319|O2|Outcome|General Health Education|General Health Education: A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
73017|NCT02124863|B1|Baseline|Intrapulmonary Percussive Ventilation|"number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding~Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O"
72890|NCT02126319|O1|Outcome|Cognitive Affective Preparation|"Cognitive Affective preparation: Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (pre-live) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)"
72891|NCT02126319|O2|Outcome|General Health Education|General Health Education: A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
72892|NCT02126319|O1|Outcome|Cognitive Affective Preparation|"Cognitive Affective preparation: Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (pre-live) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)"
72893|NCT02126319|O2|Outcome|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
72894|NCT02126319|O1|Outcome|Cognitive Affective Preparation|Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (“pre-live”) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
72895|NCT02126319|O2|Outcome|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
72896|NCT02126319|O1|Outcome|Cognitive Affective Preparation|Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (“pre-live”) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
72897|NCT02126319|O2|Outcome|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
72898|NCT02126319|O1|Outcome|Cognitive Affective Preparation|Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (“pre-live”) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
72899|NCT02126319|O2|Outcome|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
72900|NCT02126319|O1|Outcome|Cognitive Affective Preparation|Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (“pre-live”) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
72924|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
76802|NCT02104804|O2|Outcome|Vs. Placebo Plus Insulin|Patients receiving placebo 5 mg plus insulin
72901|NCT02126319|O2|Outcome|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
72902|NCT02126319|O1|Outcome|Cognitive Affective Preparation|Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (“pre-live”) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
72903|NCT02126319|E2|Reported Event|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
72904|NCT02126319|E1|Reported Event|Cognitive Affective Preparation|Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (“pre-live”) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
72905|NCT02126306|B3|Baseline|Total|Total of all reporting groups
72906|NCT02126306|B2|Baseline|Beta Glucosylceramide|"Beta Glucosylceramide~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo"
72907|NCT02126306|B1|Baseline|Placebo|"Placebo~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo"
72908|NCT02126306|P2|Participant Flow|Beta Glucosylceramide|"Beta Glucosylceramide 7.5 mg~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo"
72909|NCT02126306|P1|Participant Flow|Placebo|"Placebo~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo"
72910|NCT02126306|O2|Outcome|Beta Glucosylceramide|"Beta Glucosylceramide~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo NAS score"
72911|NCT02126306|O1|Outcome|Placebo|"Placebo~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo NAS score"
72912|NCT02126306|E2|Reported Event|Beta Glucosylceramide|"Beta Glucosylceramide~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo"
72913|NCT02126306|E1|Reported Event|Placebo|"Placebo~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo"
72914|NCT02125877|B3|Baseline|Total|Total of all reporting groups
72915|NCT02125877|B2|Baseline|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
72916|NCT02125877|B1|Baseline|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
72917|NCT02125877|P2|Participant Flow|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
72918|NCT02125877|P1|Participant Flow|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
72919|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
72920|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
72921|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
72922|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
72923|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
73664|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
72925|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
72926|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
72927|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
72928|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
72929|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
72930|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
72931|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
72932|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
72933|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
72934|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
72935|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
72936|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
72937|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
72938|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
72939|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
72940|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
72941|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
72942|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
72943|NCT02125877|E2|Reported Event|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
73133|NCT02124044|B2|Baseline|HIV/HCV GT-1b, 24 Wks ASV/DCV|Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients
72944|NCT02125877|E1|Reported Event|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
72945|NCT02125838|B3|Baseline|Total|Total of all reporting groups
72946|NCT02125838|B2|Baseline|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
72947|NCT02125838|B1|Baseline|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Endotracheal Tube: ETT"
72948|NCT02125838|P2|Participant Flow|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
72949|NCT02125838|P1|Participant Flow|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Endotracheal Tube: ETT"
72950|NCT02125838|O2|Outcome|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
72951|NCT02125838|O1|Outcome|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Endotracheal Tube: ETT"
72952|NCT02125838|O2|Outcome|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
72953|NCT02125838|O1|Outcome|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Endotracheal Tube: ETT"
72954|NCT02125838|O2|Outcome|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
72955|NCT02125838|O1|Outcome|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Endotracheal Tube: ETT"
72956|NCT02125838|O2|Outcome|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
72957|NCT02125838|O1|Outcome|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Endotracheal Tube: ETT"
72958|NCT02125838|O2|Outcome|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
72959|NCT02125838|O1|Outcome|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Endotracheal Tube: ETT"
72960|NCT02125838|O2|Outcome|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
72961|NCT02125838|O1|Outcome|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Endotracheal Tube: ETT"
73015|NCT02125292|E2|Reported Event|Mesalamine (Applesauce)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
72962|NCT02125838|E2|Reported Event|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
72963|NCT02125838|E1|Reported Event|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Endotracheal Tube: ETT"
72964|NCT02125734|B3|Baseline|Total|Total of all reporting groups
72965|NCT02125734|B2|Baseline|Treatment Sequence 2|Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56
72966|NCT02125734|B1|Baseline|Treatment Sequence 1|QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56
72967|NCT02125734|P2|Participant Flow|Treatment Sequence 2|Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56
72968|NCT02125734|P1|Participant Flow|Treatment Sequence 1|QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56
72969|NCT02125734|O2|Outcome|Tiotropium|
72970|NCT02125734|O1|Outcome|QVA149|
72971|NCT02125734|O2|Outcome|Tiotropium|
72972|NCT02125734|O1|Outcome|QVA149|
72973|NCT02125734|O2|Outcome|Tiotropium|
72974|NCT02125734|O1|Outcome|QVA149|
72975|NCT02125734|E2|Reported Event|Tiotropium|Tiotropium
72976|NCT02125734|E1|Reported Event|QVA149|QVA149
72977|NCT02125604|B1|Baseline|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
72978|NCT02125604|P1|Participant Flow|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
72979|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
72980|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
72981|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
72982|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
72983|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
72984|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
72985|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
72986|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
72987|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
72988|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
72989|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
72990|NCT02125604|E1|Reported Event|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
72991|NCT02125292|B1|Baseline|All Participants|
72992|NCT02125292|P6|Participant Flow|Mesalamine in Water, Then Applesauce, Then Vanilla Yogurt|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
72993|NCT02125292|P5|Participant Flow|Mesalamine in Water, Then Vanilla Yogurt, Then Applesauce|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
72994|NCT02125292|P4|Participant Flow|Mesalamine in Vanilla Yogurt, Then Water, Then Applesauce|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
73016|NCT02125292|E1|Reported Event|Mesalamine (Vanilla Yogurt)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
72995|NCT02125292|P3|Participant Flow|Mesalamine in Applesauce, Then Vanilla Yogurt, Then Water|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
72996|NCT02125292|P2|Participant Flow|Mesalamine in Applesauce, Then Water, Then Vanilla Yogurt|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
72997|NCT02125292|P1|Participant Flow|Mesalamine in Vanilla Yogurt, Then Applesauce, Then Water|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
72998|NCT02125292|O1|Outcome|All Participants|All participants who received all 3 treatments
72999|NCT02125292|O1|Outcome|All Participants|All participants who received all 3 treatments
73000|NCT02125292|O1|Outcome|All Participants|All participants who received all 3 treatments
73001|NCT02125292|O1|Outcome|All Participants|All participants who received all 3 treatments
73002|NCT02125292|O3|Outcome|Mesalamine (Dosing Cup)|One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
73003|NCT02125292|O2|Outcome|Mesalamine (Applesauce)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
73004|NCT02125292|O1|Outcome|Mesalamine (Vanilla Yogurt)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
73005|NCT02125292|O3|Outcome|Mesalamine (Dosing Cup)|One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
73006|NCT02125292|O2|Outcome|Mesalamine (Applesauce)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
73007|NCT02125292|O1|Outcome|Mesalamine (Vanilla Yogurt)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
73008|NCT02125292|O3|Outcome|Mesalamine (Dosing Cup)|One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
73009|NCT02125292|O2|Outcome|Mesalamine (Applesauce)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
73010|NCT02125292|O1|Outcome|Mesalamine (Vanilla Yogurt)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
73011|NCT02125292|O3|Outcome|Mesalamine (Dosing Cup)|One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
73012|NCT02125292|O2|Outcome|Mesalamine (Applesauce)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
73013|NCT02125292|O1|Outcome|Mesalamine (Vanilla Yogurt)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
73014|NCT02125292|E3|Reported Event|Mesalamine (Dosing Cup)|One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
76803|NCT02104804|O1|Outcome|Saxagliptin Plus Insulin|Saxagliptin 5 mg plus insulin
73018|NCT02124863|P1|Participant Flow|Intrapulmonary Percussive Ventilation|"number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding~Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O"
73019|NCT02124863|O2|Outcome|Control|mean number of refluxes during 20 min, 120 min after each meal
73020|NCT02124863|O1|Outcome|Intrapulmonary Percussive Ventilation|"number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding~Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O"
73021|NCT02124863|E2|Reported Event|Control|mean number of refluxes during 20 min, 120 min after each meal
73022|NCT02124863|E1|Reported Event|Intrapulmonary Percussive Ventilation|"number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding~Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O"
73023|NCT02124798|B1|Baseline|Belimumab 200mg Auto Injector|Eligible participants self administered once weekly dose of 200 mg/mL, of belimumab SC into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
73024|NCT02124798|P1|Participant Flow|Total|Eligible participants self administered once weekly dose of 200 milligram per milliliter (mg/mL), of belimumab subcutaneously (SC) into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
73025|NCT02124798|O1|Outcome|Belimumab 200mg Auto Injector|Eligible participants self administered once weekly dose of 200 mg/mL, of belimumab SC into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
73026|NCT02124798|O1|Outcome|Belimumab 200mg Auto Injector|Eligible participants self administered once weekly dose of 200 mg/mL, of belimumab SC into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
73027|NCT02124798|O1|Outcome|Belimumab 200mg Auto Injector|Eligible participants self administered once weekly dose of 200 mg/mL, of belimumab SC into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
73028|NCT02124798|E1|Reported Event|Belimumab 200mg Auto Injector|Eligible participants self administered once weekly dose of 200 mg/mL, of belimumab SC into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
73029|NCT02124603|B1|Baseline|Single Group|Consecutive patients scheduled for cataract surgery
73030|NCT02124603|P1|Participant Flow|Single Group|Patients undergone cataract surgery
73031|NCT02124603|O1|Outcome|Single Group|Patients undergone cataract surgery
73032|NCT02124603|O1|Outcome|Single Group|patients undergone cataract surgery
73033|NCT02124603|O1|Outcome|Single Group|Patients undergone cataract surgery
73034|NCT02124603|E1|Reported Event|Single Group|Patients to have to undergone cataract surgery
73035|NCT02124460|B3|Baseline|Total|Total of all reporting groups
73036|NCT02124460|B2|Baseline|Health Coaching|Arm: Experimental: Health Coaching The intervention for this study will consist of three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
73037|NCT02124460|B1|Baseline|Enhanced Primary Care|"Arm: No Intervention: Enhanced Primary Care We will provide current best practice to the control arm. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
73038|NCT02124460|P2|Participant Flow|Health Coaching|"The intervention group will receive the same components as the enhanced primary care group for this study plus the following elements: visits with a health coach, individualized connection to community resources and an interactive text messaging program.~Parent/child duos enrolled in the intervention group will participate in a total of six visits with a trained health coach. The health coach will coach the parent/child duos on improving obesity-related behaviors and help the family identify supports to assist with behavior change and encourage use of materials related to both specific target behaviors and available resources in the community.~Parents will receive semi-weekly text messages. The messages will alternate in structure between 1) skills training messages will deliver tips to help their child practice the study's goals and 2) self monitoring messages will ask parents to respond and track health behaviors important to this study."
73039|NCT02124460|P1|Participant Flow|Enhanced Primary Care|"We will provide current best practice to the enhanced primary care arm. We will encourage providers use clinical decision support tools and to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
73040|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
73041|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
73042|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
73043|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
73044|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
73045|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
73046|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
73047|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
73048|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
73049|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
73050|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
73051|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
73052|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
73053|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
73054|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
73055|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
73056|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
73057|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
73058|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
73059|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged by in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
73060|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
73061|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged by in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
73062|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
73063|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged by in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
73064|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
73065|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged by in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
73066|NCT02124460|E2|Reported Event|Health Coaching|"The intervention group will receive the same components as the enhanced primary care group for this study plus the following elements: visits with a health coach, individualized connection to community resources and an interactive text messaging program.~Parent/child duos enrolled in the intervention group will participate in a total of six visits with a trained health coach. The health coach will coach the parent/child duos on improving obesity-related behaviors and help the family identify supports to assist with behavior change and encourage use of materials related to both specific target behaviors and available resources in the community.~Parents will receive semi-weekly text messages. The messages will alternate in structure between 1) skills training messages will deliver tips to help their child practice the study's goals and 2) self monitoring messages will ask parents to respond and track health behaviors important to this study."
73067|NCT02124460|E1|Reported Event|Enhanced Primary Care|"We will provide current best practice to the enhanced primary care arm. We will encourage providers use clinical decision support tools and to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
73068|NCT02124304|B3|Baseline|Total|Total of all reporting groups
73069|NCT02124304|B2|Baseline|Healthy|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
73070|NCT02124304|B1|Baseline|Cervical Neck Pain|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
73071|NCT02124304|P2|Participant Flow|Healthy|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
73072|NCT02124304|P1|Participant Flow|Cervical Neck Pain|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
73073|NCT02124304|O2|Outcome|Healthy|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
73074|NCT02124304|O1|Outcome|Cervical Pain|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
73075|NCT02124304|O2|Outcome|Healthy|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
73076|NCT02124304|O1|Outcome|Cervical Pain|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
73077|NCT02124304|E2|Reported Event|Healthy|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
73078|NCT02124304|E1|Reported Event|Cervical Neck Pain|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
73079|NCT02124161|B3|Baseline|Total|Total of all reporting groups
73080|NCT02124161|B2|Baseline|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
73081|NCT02124161|B1|Baseline|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
73082|NCT02124161|P2|Participant Flow|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
73083|NCT02124161|P1|Participant Flow|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
73084|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
73085|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
73086|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
73087|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
73088|NCT02124161|O1|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
73089|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
73090|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
73091|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
73134|NCT02124044|B1|Baseline|HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325|Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients
73092|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
73093|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
73094|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
73095|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
73096|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
73097|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
73098|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
73099|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
73100|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
73101|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
73102|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
73103|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
73104|NCT02124161|E8|Reported Event|Placebo+QIV/13vPnC: at 6-Month Follow-up|All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from blood draw 1 month blood after Vaccination 2 to 6-month follow-up.
73105|NCT02124161|E7|Reported Event|13vPnC+QIV/Placebo: at 6-Month Follow-up|All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from blood draw 1 month blood after Vaccination 2 to 6-month follow-up.
73106|NCT02124161|E6|Reported Event|Placebo+QIV/13vPnC: After 13vPnC Vaccination|All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed after 13vPnC Vaccination.
73107|NCT02124161|E5|Reported Event|13vPnC+QIV/Placebo: After 13vPnC Vaccination|All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed after 13vPnC Vaccination.
73108|NCT02124161|E4|Reported Event|Placebo+QIV/13vPnC: After Vaccination 2|All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from after Vaccination 2 up to before 1 month blood draw after Vaccination 2.
73109|NCT02124161|E3|Reported Event|13vPnC+QIV/Placebo: After Vaccination 2|All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from after Vaccination 2 up to before 1 month blood draw after Vaccination 2.
73110|NCT02124161|E2|Reported Event|Placebo+QIV/13vPnC: After Vaccination 1|All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were accessed from Vaccination 1 up to before Vaccination 2.
73111|NCT02124161|E1|Reported Event|13vPnC+QIV/Placebo: After Vaccination 1|All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from Vaccination 1 up to before Vaccination 2.
73112|NCT02124122|B3|Baseline|Total|Total of all reporting groups
73113|NCT02124122|B2|Baseline|Placebo|"Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).~Placebo: Placebo"
73114|NCT02124122|B1|Baseline|Lactobacillus|"Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).~Lactobacillus reuteri: Probiotic"
73115|NCT02124122|P2|Participant Flow|Placebo|"Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).~Placebo: Placebo"
73116|NCT02124122|P1|Participant Flow|Lactobacillus|"Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).~Lactobacillus reuteri: Probiotic"
73117|NCT02124122|O2|Outcome|Placebo|"Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).~Placebo: Placebo"
73118|NCT02124122|O1|Outcome|Lactobacillus|"Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).~Lactobacillus reuteri: Probiotic"
73119|NCT02124122|O2|Outcome|Placebo|"Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).~Placebo: Placebo"
73120|NCT02124122|O1|Outcome|Lactobacillus|"Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).~Lactobacillus reuteri: Probiotic"
73121|NCT02124122|E2|Reported Event|Placebo|"Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).~Placebo: Placebo"
73122|NCT02124122|E1|Reported Event|Lactobacillus|"Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).~Lactobacillus reuteri: Probiotic"
73123|NCT02124083|B1|Baseline|Vorinostat|Trial participants were treated with Vorinostat (3 days on/4 days off regimen) to limit toxicity. Subjects were initially dosed with 200 mg (two 100 mg capsules) by mouth daily for three months, followed by dose escalation to 400 mg (four 100 mg capsules) by mouth daily for three months.
73124|NCT02124083|P1|Participant Flow|Vorinostat|Trial participants were treated with Vorinostat (3 days on/4 days off regimen) to limit toxicity. Subjects were initially dosed with 200 mg (two 100 mg capsules) by mouth daily for three months, followed by dose escalation to 400 mg (four 100 mg capsules) by mouth daily for three months.
73125|NCT02124083|O1|Outcome|Vorinostat|Trial participants were treated with Vorinostat (3 days on/4 days off regimen) to limit toxicity. Subjects were initially dosed with 200 mg (two 100 mg capsules) by mouth daily for three months, followed by dose escalation to 400 mg (four 100 mg capsules) by mouth daily for three months.
73126|NCT02124083|O1|Outcome|Vorinostat|Trial participants were treated with Vorinostat (3 days on/4 days off regimen) to limit toxicity. Subjects were initially dosed with 200 mg (two 100 mg capsules) by mouth daily for three months, followed by dose escalation to 400 mg (four 100 mg capsules) by mouth daily for three months.
73127|NCT02124083|O1|Outcome|Vorinostat|Trial participants were treated with Vorinostat (3 days on/4 days off regimen) to limit toxicity. Subjects were initially dosed with 200 mg (two 100 mg capsules) by mouth daily for three months, followed by dose escalation to 400 mg (four 100 mg capsules) by mouth daily for three months.
73128|NCT02124083|O1|Outcome|Vorinostat|Trial participants were treated with Vorinostat (3 days on/4 days off regimen) to limit toxicity. Subjects were initially dosed with 200 mg (two 100 mg capsules) by mouth daily for three months, followed by dose escalation to 400 mg (four 100 mg capsules) by mouth daily for three months.
73129|NCT02124083|O1|Outcome|Vorinostat|Trial participants were treated with Vorinostat (3 days on/4 days off regimen) to limit toxicity. Subjects were initially dosed with 200 mg (two 100 mg capsules) by mouth daily for three months, followed by dose escalation to 400 mg (four 100 mg capsules) by mouth daily for three months.
73130|NCT02124083|O1|Outcome|Vorinostat|Trial participants were treated with Vorinostat (3 days on/4 days off regimen) to limit toxicity. Subjects were initially dosed with 200 mg (two 100 mg capsules) by mouth daily for three months, followed by dose escalation to 400 mg (four 100 mg capsules) by mouth daily for three months.
73131|NCT02124083|E1|Reported Event|Vorinostat|Trial participants were treated with Vorinostat (3 days on/4 days off regimen) to limit toxicity. Subjects were initially dosed with 200 mg (two 100 mg capsules) by mouth daily for three months, followed by dose escalation to 400 mg (four 100 mg capsules) by mouth daily for three months.
73132|NCT02124044|B3|Baseline|Total|Total of all reporting groups
76804|NCT02104804|O2|Outcome|Vs. Placebo Plus Insulin|Patients receiving placebo 5 mg plus insulin
73135|NCT02124044|P2|Participant Flow|HIV/HCV GT-1b, 24 Wks ASV/DCV|Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients
73136|NCT02124044|P1|Participant Flow|HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325|Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients
73137|NCT02124044|O2|Outcome|HIV/HCV GT-1b, 24 Wks ASV/DCV|Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients
73138|NCT02124044|O1|Outcome|HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325|Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients
73139|NCT02124044|E2|Reported Event|HIV/HCV GT-1b, 24 Wks ASV/DCV|Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients
73140|NCT02124044|E1|Reported Event|HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325|Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients
73141|NCT02123745|B1|Baseline|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
73142|NCT02123745|P1|Participant Flow|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
73143|NCT02123745|O1|Outcome|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
73144|NCT02123745|O1|Outcome|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
73145|NCT02123745|O1|Outcome|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
73146|NCT02123745|O1|Outcome|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
73147|NCT02123745|O1|Outcome|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
73148|NCT02123745|E1|Reported Event|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
73149|NCT02123472|B1|Baseline|Overall Study|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion)
73150|NCT02123472|P2|Participant Flow|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test – 1 occasion) and Cephalexin A formulation (Treatment A, Reference – 1 occasion).There was an interval of 1 day between doses.
73151|NCT02123472|P1|Participant Flow|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).There was an interval of 1 day between doses.
73152|NCT02123472|O2|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
73153|NCT02123472|O1|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
73154|NCT02123472|O2|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
73155|NCT02123472|O1|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
73156|NCT02123472|O2|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
73157|NCT02123472|O1|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
73158|NCT02123472|E2|Reported Event|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
73159|NCT02123472|E1|Reported Event|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
73160|NCT02123459|B1|Baseline|Overall Study|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).
73161|NCT02123459|P2|Participant Flow|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test – 1 occasion) and Cephalexin A formulation (Treatment A, Reference – 1 occasion).There was an interval of 1 day between doses.
73162|NCT02123459|P1|Participant Flow|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).There was an interval of 1 day between doses.
73163|NCT02123459|O2|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods
73164|NCT02123459|O1|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods
73165|NCT02123459|O2|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods
73166|NCT02123459|O1|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods
73167|NCT02123459|O2|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods
73168|NCT02123459|O1|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods
73169|NCT02123459|E2|Reported Event|Cephalexin (Test)|"Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods~Cephalexin: Administered orally"
73170|NCT02123459|E1|Reported Event|Cephalexin (Reference)|"Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods~Cephalexin: Administered orally"
73171|NCT02123446|B1|Baseline|Overall Study|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).
73172|NCT02123446|P2|Participant Flow|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test – 1 occasion) and Cephalexin A formulation (Treatment A, Reference – 1 occasion).There was an interval of 1 day between doses.
73173|NCT02123446|P1|Participant Flow|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).There was an interval of 1 day between doses.
73174|NCT02123446|O2|Outcome|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
73175|NCT02123446|O1|Outcome|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
73176|NCT02123446|O2|Outcome|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
73177|NCT02123446|O1|Outcome|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
73178|NCT02123446|O2|Outcome|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
73179|NCT02123446|O1|Outcome|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
73180|NCT02123446|E2|Reported Event|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
73181|NCT02123446|E1|Reported Event|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
73182|NCT02123329|B3|Baseline|Total|Total of all reporting groups
73183|NCT02123329|B2|Baseline|Intervention Arm|Participants assigned to the intervention arm will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks in addition to nicotine replacement therapy.
73184|NCT02123329|B1|Baseline|Control Arm|"Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).~Control arm (i.e: regular care): Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT)."
73185|NCT02123329|P2|Participant Flow|Intervention Arm|Participants assigned to the intervention arm will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks in addition to nicotine replacement therapy.
73186|NCT02123329|P1|Participant Flow|Control Arm|"Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).~Control arm (i.e: regular care): Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT)."
73187|NCT02123329|O2|Outcome|Intervention Arm|Participants assigned to the intervention arm will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks in addition to nicotine replacement therapy.
73188|NCT02123329|O1|Outcome|Control Arm|"Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).~Control arm (i.e: regular care): Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT)."
73665|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
73189|NCT02123329|O2|Outcome|Intervention Arm|Participants assigned to the intervention arm will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks in addition to nicotine replacement therapy.
73190|NCT02123329|O1|Outcome|Control Arm|"Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).~Control arm (i.e: regular care): Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT)."
73191|NCT02123329|O2|Outcome|Intervention Arm|Participants assigned to the intervention arm will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks in addition to nicotine replacement therapy.
73192|NCT02123329|O1|Outcome|Control Arm|"Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).~Control arm (i.e: regular care): Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT)."
73193|NCT02123329|O2|Outcome|Intervention Arm|Participants assigned to the intervention arm will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks in addition to nicotine replacement therapy.
73194|NCT02123329|O1|Outcome|Control Arm|"Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).~Control arm (i.e: regular care): Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT)."
73195|NCT02123329|O2|Outcome|Intervention Arm|Participants assigned to the intervention arm will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks in addition to nicotine replacement therapy.
73196|NCT02123329|O1|Outcome|Control Arm|"Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).~Control arm (i.e: regular care): Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT)."
73197|NCT02123329|O2|Outcome|Intervention Arm|Participants assigned to the intervention arm will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks in addition to nicotine replacement therapy.
73198|NCT02123329|O1|Outcome|Control Arm|"Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).~Control arm (i.e: regular care): Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT)."
73199|NCT02123329|O2|Outcome|Intervention Arm|Participants assigned to the intervention arm will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks in addition to nicotine replacement therapy.
73200|NCT02123329|O1|Outcome|Control Arm|"Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).~Control arm (i.e: regular care): Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT)."
73201|NCT02123329|O2|Outcome|Intervention Arm|Participants assigned to the intervention arm will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks in addition to nicotine replacement therapy.
73202|NCT02123329|O1|Outcome|Control Arm|"Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).~Control arm (i.e: regular care): Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT)."
73203|NCT02123329|O2|Outcome|Intervention Arm|Participants assigned to the intervention arm will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks in addition to nicotine replacement therapy.
73204|NCT02123329|O1|Outcome|Control Arm|"Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).~Control arm (i.e: regular care): Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT)."
73205|NCT02123329|O2|Outcome|Intervention Arm|Participants assigned to the intervention arm will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks in addition to nicotine replacement therapy.
73666|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
73206|NCT02123329|O1|Outcome|Control Arm|"Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).~Control arm (i.e: regular care): Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT)."
73207|NCT02123329|O2|Outcome|Intervention Arm|Participants assigned to the intervention arm will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks in addition to nicotine replacement therapy.
73208|NCT02123329|O1|Outcome|Control Arm|"Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).~Control arm (i.e: regular care): Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT)."
73209|NCT02123329|E2|Reported Event|Intervention Arm|Participants assigned to the intervention arm will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks in addition to nicotine replacement therapy.
73210|NCT02123329|E1|Reported Event|Control Arm|"Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).~Control arm (i.e: regular care): Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT)."
73211|NCT02123017|B4|Baseline|Total|Total of all reporting groups
73212|NCT02123017|B3|Baseline|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
73213|NCT02123017|B2|Baseline|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
73214|NCT02123017|B1|Baseline|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
73215|NCT02123017|P3|Participant Flow|180 Grams Crystalline Lactulose|15 mg bisacodyl, plus 60 grams crystalline lactulose x 3 doses
73216|NCT02123017|P2|Participant Flow|135 Grams Crystalline Lactulose|15 mg bisacodyl, plus 45 grams crystalline lactulose x 3 doses
73217|NCT02123017|P1|Participant Flow|90 Grams Crystalline Lactulose|15 mg bisacodyl, plus 30 grams crystalline lactulose x 3 doses
73218|NCT02123017|O3|Outcome|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
73219|NCT02123017|O2|Outcome|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
73220|NCT02123017|O1|Outcome|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
73221|NCT02123017|O3|Outcome|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
73222|NCT02123017|O2|Outcome|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
73223|NCT02123017|O1|Outcome|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
73224|NCT02123017|O3|Outcome|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
73225|NCT02123017|O2|Outcome|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
73226|NCT02123017|O1|Outcome|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
73227|NCT02123017|O3|Outcome|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
73228|NCT02123017|O2|Outcome|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
73229|NCT02123017|O1|Outcome|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
73230|NCT02123017|E3|Reported Event|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
73231|NCT02123017|E2|Reported Event|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
73232|NCT02123017|E1|Reported Event|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
73233|NCT02122796|B3|Baseline|Total|Total of all reporting groups
73234|NCT02122796|B2|Baseline|Standard of Care|Standard of care post-mastectomy.
73235|NCT02122796|B1|Baseline|Acupuncture|"Two sessions of acupuncture, at least twelve hours apart, post-mastectomy.~Acupuncture: Acupuncture involves inserting thin, sterile needles into the skin at certain points in the body."
73236|NCT02122796|P2|Participant Flow|Standard of Care|Standard of care post-mastectomy.
73237|NCT02122796|P1|Participant Flow|Acupuncture|"Two sessions of acupuncture, at least twelve hours apart, post-mastectomy.~Acupuncture: Acupuncture involves inserting thin, sterile needles into the skin at certain points in the body."
73238|NCT02122796|O2|Outcome|Standard of Care|Standard of care post-mastectomy.
73239|NCT02122796|O1|Outcome|Acupuncture|"Two sessions of acupuncture, at least twelve hours apart, post-mastectomy.~Acupuncture: Acupuncture involves inserting thin, sterile needles into the skin at certain points in the body."
73240|NCT02122796|O2|Outcome|Standard of Care|Standard of care post-mastectomy.
73241|NCT02122796|O1|Outcome|Acupuncture|"Two sessions of acupuncture, at least twelve hours apart, post-mastectomy.~Acupuncture: Acupuncture involves inserting thin, sterile needles into the skin at certain points in the body."
73242|NCT02122796|O2|Outcome|Standard of Care|Standard of care post-mastectomy.
73243|NCT02122796|O1|Outcome|Acupuncture|"Two sessions of acupuncture, at least twelve hours apart, post-mastectomy.~Acupuncture: Acupuncture involves inserting thin, sterile needles into the skin at certain points in the body."
73244|NCT02122796|O2|Outcome|Standard of Care|Standard of care post-mastectomy.
76805|NCT02104804|O1|Outcome|Saxagliptin Plus Insulin|Saxagliptin 5 mg plus insulin
73245|NCT02122796|O1|Outcome|Acupuncture|"Two sessions of acupuncture, at least twelve hours apart, post-mastectomy.~Acupuncture: Acupuncture involves inserting thin, sterile needles into the skin at certain points in the body."
73246|NCT02122796|O1|Outcome|Patients Undergoing Mastectomy Surgery|Number of individuals having mastectomy surgery who were approached for participation in the trial
73247|NCT02122796|E2|Reported Event|Standard of Care|Standard of care post-mastectomy.
73248|NCT02122796|E1|Reported Event|Acupuncture|"Two sessions of acupuncture, at least twelve hours apart, post-mastectomy.~Acupuncture: Acupuncture involves inserting thin, sterile needles into the skin at certain points in the body."
73249|NCT02122549|B1|Baseline|HWD1000|"Subjects using HWD1000~HWD1000: Wearable cardioverter-defibrillator designed for inpatient use"
73250|NCT02122549|P1|Participant Flow|HWD1000|"Subjects using HWD1000~HWD1000: Wearable cardioverter-defibrillator designed for inpatient use"
73251|NCT02122549|O1|Outcome|HWD1000|Subjects wearing the HWD 1000.
73252|NCT02122549|E1|Reported Event|HWD1000|"Subjects using HWD1000~HWD1000: Wearable cardioverter-defibrillator designed for inpatient use"
73253|NCT02122445|B1|Baseline|Low Back Pain|"Lower body exercises before and after the application of Cramer Sports Motion tape~Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip"
73254|NCT02122445|P1|Participant Flow|Low Back Pain|"Lower body exercises before and after the application of Cramer Sports Motion tape~Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip"
73255|NCT02122445|O1|Outcome|Low Back Pain|"Lower body exercises before and after the application of Cramer Sports Motion tape~Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip"
73256|NCT02122445|O1|Outcome|Low Back Pain|"Lower body exercises before and after the application of Cramer Sports Motion tape~Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip"
73257|NCT02122445|E1|Reported Event|Low Back Pain|"Lower body exercises before and after the application of Cramer Sports Motion tape~Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip"
73258|NCT02122406|B1|Baseline|Patients RA-BIO|Patients with rheumatoid arthritis treated with biological drugs
73259|NCT02122406|P1|Participant Flow|Patients RA-BIO|Patients with rheumatoid arthritis treated with biological drugs
73260|NCT02122406|O1|Outcome|Patients RA-BIO|Patients with rheumatoid arthritis treated with biological drugs
73261|NCT02122406|E1|Reported Event|Patients RA-BIO|Patients with rheumatoid arthritis treated with biological drugs
73262|NCT02122146|B9|Baseline|Total|Total of all reporting groups
73263|NCT02122146|B8|Baseline|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73264|NCT02122146|B7|Baseline|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73265|NCT02122146|B6|Baseline|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73266|NCT02122146|B5|Baseline|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73267|NCT02122146|B4|Baseline|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73268|NCT02122146|B3|Baseline|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73269|NCT02122146|B2|Baseline|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73270|NCT02122146|B1|Baseline|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73271|NCT02122146|P8|Participant Flow|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73272|NCT02122146|P7|Participant Flow|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73549|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
73273|NCT02122146|P6|Participant Flow|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73274|NCT02122146|P5|Participant Flow|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73275|NCT02122146|P4|Participant Flow|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73276|NCT02122146|P3|Participant Flow|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73277|NCT02122146|P2|Participant Flow|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73278|NCT02122146|P1|Participant Flow|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73279|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73280|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73281|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73282|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73283|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73284|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73285|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73286|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73287|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73288|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73289|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73290|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73667|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
76806|NCT02104804|E2|Reported Event|SAXAGLIPTIN 5 MG QD + INSULIN WITH OR WITHOUT METFORMIN|
73291|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73292|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73293|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73294|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73295|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73296|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73297|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73298|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73299|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73300|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73301|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73302|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73303|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73304|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73305|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73306|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73307|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73308|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73550|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
73309|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73310|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73311|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73312|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73313|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73314|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73315|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73316|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73317|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73318|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73319|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73320|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73321|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73322|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73323|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73324|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73325|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73326|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73668|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
76807|NCT02104804|E1|Reported Event|PLACEBO QD + INSULIN WITH OR WITHOUT METFORMIN|
73327|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73328|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73329|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73330|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73331|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73332|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73333|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73334|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73335|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73336|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73337|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73338|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73339|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73340|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73341|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73342|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73343|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73344|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73551|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
73345|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73346|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73347|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73348|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73349|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73350|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73351|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73352|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73353|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73354|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73355|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73356|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73357|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73358|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73359|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73360|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73361|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73362|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73552|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
73363|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73364|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73365|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73366|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73367|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73368|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73369|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73370|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73371|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73372|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73373|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73374|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73375|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73376|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73377|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73378|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73379|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73380|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73553|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
73381|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73382|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73383|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73384|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73385|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73386|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73387|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73388|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73389|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73390|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73391|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73392|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73393|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73394|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73395|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73396|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73397|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73398|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73669|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
76808|NCT02104505|B3|Baseline|Total|Total of all reporting groups
73399|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73400|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73401|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73402|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73403|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73404|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73405|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73406|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73407|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73408|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73409|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73410|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73411|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73412|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73413|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73414|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73415|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73416|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73554|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
73417|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73418|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73419|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73420|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73421|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73422|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73423|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73424|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73425|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73426|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73427|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73428|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73429|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73430|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73431|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73432|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73433|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73434|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73555|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
73435|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73436|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73437|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73438|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73439|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73440|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73441|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73442|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73443|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73444|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73445|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73446|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73447|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73448|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73449|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73450|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73451|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73452|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73556|NCT02121847|E1|Reported Event|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
73453|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73454|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73455|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73456|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73457|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73458|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73459|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73460|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73461|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73462|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73463|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73464|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73465|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73466|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73467|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73468|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73469|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73470|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73653|NCT02121483|P3|Participant Flow|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
76902|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
73471|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73472|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73473|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73474|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73475|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73476|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73477|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73478|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73479|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73480|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73481|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73482|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73483|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73484|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73485|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73486|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73487|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73488|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73654|NCT02121483|P2|Participant Flow|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
73655|NCT02121483|P1|Participant Flow|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
73489|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73490|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73491|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73492|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73493|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73494|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73495|NCT02122146|O8|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73496|NCT02122146|O7|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73497|NCT02122146|O6|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73498|NCT02122146|O5|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73499|NCT02122146|O4|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73500|NCT02122146|O3|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73501|NCT02122146|O2|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73502|NCT02122146|O1|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73503|NCT02122146|E9|Reported Event|Total|Treatment Group Description TBD
73504|NCT02122146|E8|Reported Event|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73505|NCT02122146|E7|Reported Event|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73506|NCT02122146|E6|Reported Event|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73507|NCT02122146|E5|Reported Event|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73656|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
73508|NCT02122146|E4|Reported Event|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73509|NCT02122146|E3|Reported Event|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73510|NCT02122146|E2|Reported Event|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
73511|NCT02122146|E1|Reported Event|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
73512|NCT02121860|B5|Baseline|Total|Total of all reporting groups
73513|NCT02121860|B4|Baseline|Normal Hepatic Function|Medically healthy as determined by the investigator
73514|NCT02121860|B3|Baseline|Child-Pugh Class C|Severe Hepatic Impairment
73515|NCT02121860|B2|Baseline|Child-Pugh Class B|Moderate Hepatic Impairment
73516|NCT02121860|B1|Baseline|Child-Pugh Class A|Mild Hepatic Impairment
73517|NCT02121860|P4|Participant Flow|Child-Pugh Class C|Severe hepatic impairment
73518|NCT02121860|P3|Participant Flow|Child-Pugh Class B|Moderate hepatic impairment
73519|NCT02121860|P2|Participant Flow|Child-Pugh Class A|Mild hepatic impairment
73520|NCT02121860|P1|Participant Flow|Normal Hepatic Function|Medically healthy as determined by the investigator
73521|NCT02121860|O4|Outcome|Child-Pugh Class C|Severe Hepatic Impairment
73522|NCT02121860|O3|Outcome|Child-Pugh Class B|Moderate Hepatic Impairment
73523|NCT02121860|O2|Outcome|Child-Pugh Class A|Mild Hepatic Impairment
73524|NCT02121860|O1|Outcome|Normal Hepatic Function|Medically healthy as determined by the investigator
73525|NCT02121860|O4|Outcome|Child-Pugh Class C|Severe Hepatic Impairment
73526|NCT02121860|O3|Outcome|Child-Pugh Class B|Moderate Hepatic Impairment
73527|NCT02121860|O2|Outcome|Child-Pugh Class A|Mild Hepatic Impairment
73528|NCT02121860|O1|Outcome|Normal Hepatic Function|Medically healthy as determined by the investigator
73529|NCT02121860|O4|Outcome|Child-Pugh Class C|Severe Hepatic Impairment
73530|NCT02121860|O3|Outcome|Child-Pugh Class B|Moderate Hepatic Impairment
73531|NCT02121860|O2|Outcome|Child-Pugh Class A|Mild Hepatic Impairment
73532|NCT02121860|O1|Outcome|Normal Hepatic Function|Medically healthy as determined by the investigator
73533|NCT02121860|O4|Outcome|Child-Pugh Class C|Severe Hepatic Impairment
73534|NCT02121860|O3|Outcome|Child-Pugh Class B|Moderate Hepatic Impairment
73535|NCT02121860|O2|Outcome|Child-Pugh Class A|Mild Hepatic Impairment
73536|NCT02121860|O1|Outcome|Normal Hepatic Function|Medically healthy as determined by the investigator
73537|NCT02121860|E1|Reported Event|IDN-6556|Single 50 mg oral dose of IDN-6556
73538|NCT02121847|B1|Baseline|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
73539|NCT02121847|P1|Participant Flow|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
73540|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
73541|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
73542|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
73543|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
73544|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
73545|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
73546|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
73547|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
73548|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
73557|NCT02121808|B1|Baseline|Position and Spontaneous vs Pressure Support|"The effect of position and spontaneous vs pressure support ventilation on FRC was assessed on patients recruited. The six possible combination were tested on every patients in a randomized order.~Intervention 1 : Supine + NIPPV Intervention 2 : Supine + Tidal volume spontaneous ventilation Intervention 3 : Beach chair (Back 25 deg) + NIPPV Intervention 4 : Beach chair (Back 25 deg) + Tidal volume spontaneous ventilation Intervention 5 : Proclive (Global 25 deg) + NIPPV Intervention 6 : Proclive (Global 25 deg) + Tidal volume spontaneous ventilation"
73558|NCT02121808|P1|Participant Flow|Position and Spontaneous vs Pressure Support|"The effect of position and spontaneous vs pressure support ventilation on FRC was assessed on patients recruited. The six possible combination were tested on every patients in a randomized order.~Intervention 1 : Supine + NIPPV Intervention 2 : Supine + Tidal volume spontaneous ventilation Intervention 3 : Beach chair (Back 25 deg) + NIPPV Intervention 4 : Beach chair (Back 25 deg) + Tidal volume spontaneous ventilation Intervention 5 : Proclive (Global 25 deg) + NIPPV Intervention 6 : Proclive (Global 25 deg) + Tidal volume spontaneous ventilation"
73559|NCT02121808|O6|Outcome|6. Proclive (Global 25 Deg) + Tidal Volume Spontaneous Ventila|Intervention 6 : Proclive (Global 25 deg) + Tidal volume spontaneous ventilation
73560|NCT02121808|O5|Outcome|5. Proclive (Global 25 Deg) + NIPPV|Intervention 5 : Proclive (Global 25 deg) + NIPPV
73561|NCT02121808|O4|Outcome|4. Beach Chair (Back 25 Deg) + Tidal Volume Spontaneous Ventil|Intervention 4 : Beach chair (Back 25 deg) + Tidal volume spontaneous ventilation
73562|NCT02121808|O3|Outcome|3. Beach Chair (Back 25 Deg) + NIPPV|Intervention 3 : Beach chair (Back 25 deg) + NIPPV
73563|NCT02121808|O2|Outcome|2. Supine + Tidal Volume Spontaneous Ventilation|Intervention 2 : Supine + Tidal volume spontaneous ventilation
73564|NCT02121808|O1|Outcome|1. Supine + NIPPV|Intervention 1 : Supine + NIPPV
73565|NCT02121808|E1|Reported Event|Position and Spontaneous vs Pressure Support|"The effect of position and spontaneous vs pressure support ventilation on FRC was assessed on patients recruited. The six possible combination were tested on every patients in a randomized order.~Intervention 1 : Supine + NIPPV Intervention 2 : Supine + Tidal volume spontaneous ventilation Intervention 3 : Beach chair (Back 25 deg) + NIPPV Intervention 4 : Beach chair (Back 25 deg) + Tidal volume spontaneous ventilation Intervention 5 : Proclive (Global 25 deg) + NIPPV Intervention 6 : Proclive (Global 25 deg) + Tidal volume spontaneous ventilation"
73566|NCT02121795|B3|Baseline|Total|Total of all reporting groups
73567|NCT02121795|B2|Baseline|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
73568|NCT02121795|B1|Baseline|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
73569|NCT02121795|P2|Participant Flow|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
73570|NCT02121795|P1|Participant Flow|F/TAF + 3rd Agent|Emtricitabine/tenofovir alafenamide (F/TAF) (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks
73571|NCT02121795|O2|Outcome|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
73572|NCT02121795|O1|Outcome|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
73573|NCT02121795|O2|Outcome|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
73574|NCT02121795|O1|Outcome|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
73575|NCT02121795|O2|Outcome|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
73576|NCT02121795|O1|Outcome|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
73577|NCT02121795|O2|Outcome|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
73578|NCT02121795|O1|Outcome|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
73579|NCT02121795|O2|Outcome|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
73580|NCT02121795|O1|Outcome|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
73581|NCT02121795|E2|Reported Event|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
73582|NCT02121795|E1|Reported Event|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
73583|NCT02121535|B3|Baseline|Total|Total of all reporting groups
73584|NCT02121535|B2|Baseline|Sequence RTTR|Oral administration of study drugs in the following order: R (period 1) - T (period 2) - T (period 3) - R (period 4). T: telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fix dose tab, once daily; R: telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily. The washout period between drug administrations had to be at least 14 days from the study drug administration of the previous period.
73585|NCT02121535|B1|Baseline|Sequence TRRT|"Oral administration of study drugs in the following order: T (period 1) - R(period 2) - R (period 3) - T (period 4).~T: telmisartan 80mg+amlodipine 5mg+ hydrochlorothiazide (HCTZ) 12.5mg fix dose tab, once daily; R: telmisartan 80mg+amlodipine 5mg fixed dose combination (FDC) + HCTZ 12.5mg tablet , once daily.~The washout period between drug administrations had to be at least 14 days from the study drug administration of the previous period."
73586|NCT02121535|P2|Participant Flow|Sequence RTTR|"Oral administration of study drugs in the following order: R (period 1) - T (period 2) - T (period 3) - R (period 4).~T: telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fix dose tab, once daily; R: telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily. The washout period between drug administrations had to be at least 14 days from the study drug administration of the previous period."
73587|NCT02121535|P1|Participant Flow|Sequence TRRT|"Oral administration of study drugs in the following order: T (period 1) - R(period 2) - R (period 3) - T (period 4).~T: telmisartan 80mg+amlodipine 5mg+ hydrochlorothiazide (HCTZ) 12.5mg fix dose tab, once daily; R: telmisartan 80mg+amlodipine 5mg fixed dose combination (FDC) + HCTZ 12.5mg tablet , once daily.~The washout period between drug administrations had to be at least 14 days from the study drug administration of the previous period."
73588|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
73589|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
73590|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
73591|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
73592|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
73593|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
73594|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
73595|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
73596|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
73597|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
73598|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
73599|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
73600|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
73601|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
73602|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
73603|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
73604|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
73605|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
73606|NCT02121535|E3|Reported Event|Total (All Patients)|Total of all the participants analyzed
73607|NCT02121535|E2|Reported Event|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
73608|NCT02121535|E1|Reported Event|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
73609|NCT02121522|B1|Baseline|BI 144807|Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
73610|NCT02121522|P1|Participant Flow|BI 144807|Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
73611|NCT02121522|O1|Outcome|BI 144807|Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
73612|NCT02121522|O1|Outcome|BI 144807|Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
73613|NCT02121522|E1|Reported Event|BI 144807|Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
73614|NCT02121509|B3|Baseline|Total|Total of all reporting groups
73615|NCT02121509|B2|Baseline|FDC 1500 Fed or L+M 1500 Fed|"The subjects in Part 2 were randomly allocated to 1 of the 2 treatment sequences T fed_R fed or R fed_T fed.~FDC 1500 fed (T fed): 5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after after a high-fat, high-calorie meal.~L+M 1500 fed (R fed): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
73616|NCT02121509|B1|Baseline|FDC 1500 Fasted or L+M 1500 Fasted|"The subjects in Part 1 were randomly allocated to 1 of the 2 treatment sequences T fasted_R fasted or R fasted_T fasted.~FDC 1500 fasted (T fasted): 5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.~L+M 1500 fasted (R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
73617|NCT02121509|P4|Participant Flow|L+M 1500 Fed / FDC 1500 Fed|"Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin XR (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR orally with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
73618|NCT02121509|P3|Participant Flow|FDC 1500 Fed / L+M 1500 Fed|"Linagliptin+ Metformin XR (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) followed by Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
73619|NCT02121509|P2|Participant Flow|L+M 1500 Fasted / FDC 1500 Fasted|"Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin XR (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR orally with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
73657|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
73620|NCT02121509|P1|Participant Flow|FDC 1500 Fasted / L+M 1500 Fasted|"Linagliptin+ Metformin extended release (XR) (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) followed by Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
73621|NCT02121509|O4|Outcome|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
73622|NCT02121509|O3|Outcome|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
73623|NCT02121509|O2|Outcome|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
73624|NCT02121509|O1|Outcome|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
73625|NCT02121509|O4|Outcome|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
73626|NCT02121509|O3|Outcome|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
73627|NCT02121509|O2|Outcome|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
73628|NCT02121509|O1|Outcome|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
73629|NCT02121509|O4|Outcome|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
73630|NCT02121509|O3|Outcome|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
73631|NCT02121509|O2|Outcome|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
73632|NCT02121509|O1|Outcome|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
73633|NCT02121509|O4|Outcome|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
73634|NCT02121509|O3|Outcome|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
73635|NCT02121509|O2|Outcome|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
73636|NCT02121509|O1|Outcome|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
73637|NCT02121509|O4|Outcome|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
73638|NCT02121509|O3|Outcome|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
73639|NCT02121509|O2|Outcome|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
73640|NCT02121509|O1|Outcome|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
73641|NCT02121509|O4|Outcome|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
73642|NCT02121509|O3|Outcome|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
73643|NCT02121509|O2|Outcome|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
73644|NCT02121509|O1|Outcome|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
73645|NCT02121509|E4|Reported Event|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
73646|NCT02121509|E3|Reported Event|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
73647|NCT02121509|E2|Reported Event|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
73648|NCT02121509|E1|Reported Event|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
73649|NCT02121483|B4|Baseline|Total|Total of all reporting groups
73650|NCT02121483|B3|Baseline|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
73651|NCT02121483|B2|Baseline|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
73652|NCT02121483|B1|Baseline|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
73670|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
73671|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
73672|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
73673|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
73674|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
73675|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
73676|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
73677|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
73678|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
73679|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
73680|NCT02121483|E3|Reported Event|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
73681|NCT02121483|E2|Reported Event|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
73682|NCT02121483|E1|Reported Event|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
73683|NCT02121418|B1|Baseline|Treatment (Decitabine, Cytarabine)|Patients receive decitabine IV daily on days 1-10 and cytarabine IV QD on days 1-7. Treatment repeats every 28-35 days for 2 courses in the absence of disease progression or unacceptable toxicity. After course 3, patients achieving remission will receive 1-2 more courses of therapy at the same dose. Patients in remission with significant side effects will receive decitabine and cytarabine at decreased doses. Patients not achieving remission will not receive any more treatment. 12 patients were consented and treated.
73684|NCT02121418|P1|Participant Flow|Treatment (Decitabine, Cytarabine)|Patients receive decitabine IV daily on days 1-10 and cytarabine IV QD on days 1-7. Treatment repeats every 28-35 days for 2 courses in the absence of disease progression or unacceptable toxicity. After course 3, patients achieving remission will receive 1-2 more courses of therapy at the same dose. Patients in remission with significant side effects will receive decitabine and cytarabine at decreased doses. Patients not achieving remission will not receive any more treatment. 12 patients were consented and treated.
73685|NCT02121418|O1|Outcome|Treatment (Decitabine, Cytarabine)|Patients receive decitabine IV daily on days 1-10 and cytarabine IV QD on days 1-7. Treatment repeats every 28-35 days for 2 courses in the absence of disease progression or unacceptable toxicity. After course 3, patients achieving remission will receive 1-2 more courses of therapy at the same dose. Patients in remission with significant side effects will receive decitabine and cytarabine at decreased doses. Patients not achieving remission will not receive any more treatment. 12 patients were consented and treated.
73686|NCT02121418|O1|Outcome|Treatment (Decitabine, Cytarabine)|Patients receive decitabine IV daily on days 1-10 and cytarabine IV QD on days 1-7. Treatment repeats every 28-35 days for 2 courses in the absence of disease progression or unacceptable toxicity. After course 3, patients achieving remission will receive 1-2 more courses of therapy at the same dose. Patients in remission with significant side effects will receive decitabine and cytarabine at decreased doses. Patients not achieving remission will not receive any more treatment. 12 patients were consented and treated.
73687|NCT02121418|E1|Reported Event|Treatment (Decitabine, Cytarabine)|Patients receive decitabine IV daily on days 1-10 and cytarabine IV QD on days 1-7. Treatment repeats every 28-35 days for 2 courses in the absence of disease progression or unacceptable toxicity. After course 3, patients achieving remission will receive 1-2 more courses of therapy at the same dose. Patients in remission with significant side effects will receive decitabine and cytarabine at decreased doses. Patients not achieving remission will not receive any more treatment. 12 patients were consented and treated.
73688|NCT02121210|B3|Baseline|Total|Total of all reporting groups
73689|NCT02121210|B2|Baseline|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w for 24 weeks.
73690|NCT02121210|B1|Baseline|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w for 24 weeks.
73691|NCT02121210|P2|Participant Flow|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w for 24 weeks.
73692|NCT02121210|P1|Participant Flow|Sarilumab 150 mg q2w|Sarilumab 150 mg subcutaneous (SC) injection q2w for 24 weeks
73693|NCT02121210|O2|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w for 24 weeks.
73694|NCT02121210|O1|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w for 24 weeks.
73695|NCT02121210|O2|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w for 24 weeks.
73696|NCT02121210|O1|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w for 24 weeks.
73697|NCT02121210|E2|Reported Event|Sarilumab 200mg q2w|Sarilumab 200 mg SC injection q2w for 24 weeks.
73698|NCT02121210|E1|Reported Event|Sarilumab 150mg q2w|Sarilumab 150 mg SC injection q2w for 24 weeks.
73699|NCT02121067|B1|Baseline|LNG-IUS Placed at 2 Weeks Postpartum|"Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum~Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled."
73700|NCT02121067|P1|Participant Flow|LNG-IUS Placed at 2 Weeks Postpartum|"Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum~Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled."
73701|NCT02121067|O1|Outcome|LNG-IUS Placed at 2 Weeks Postpartum|"Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum~Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled."
73702|NCT02121067|O1|Outcome|LNG-IUS Placed at 2 Weeks Postpartum|"Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum~Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled"
73742|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73703|NCT02121067|O1|Outcome|LNG-IUS Placed at 2 Weeks Postpartum|"Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum~Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled"
73704|NCT02121067|E1|Reported Event|LNG-IUS Placed at 2 Weeks Postpartum|"Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum~Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled."
73705|NCT02121041|B3|Baseline|Total|Total of all reporting groups
73706|NCT02121041|B2|Baseline|ABPM Guided|"Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.~Amlodipine: Amlodipine 5 mg or 10 mg~Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg~Losartan: Losartan 50 mg or 100 mg"
73707|NCT02121041|B1|Baseline|Usual Care|Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.
73708|NCT02121041|P2|Participant Flow|ABPM Guided|"Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.~Amlodipine: Amlodipine 5 mg or 10 mg~Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg~Losartan: Losartan 50 mg or 100 mg"
73709|NCT02121041|P1|Participant Flow|Usual Care|Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.
73710|NCT02121041|O2|Outcome|ABPM Guided|"Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.~Amlodipine: Amlodipine 5 mg or 10 mg~Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg~Losartan: Losartan 50 mg or 100 mg"
73711|NCT02121041|O1|Outcome|Usual Care|Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.
73712|NCT02121041|E2|Reported Event|ABPM Guided|"Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.~Amlodipine: Amlodipine 5 mg or 10 mg~Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg~Losartan: Losartan 50 mg or 100 mg"
73713|NCT02121041|E1|Reported Event|Usual Care|Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.
73714|NCT02120833|B3|Baseline|Total|Total of all reporting groups
73715|NCT02120833|B2|Baseline|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73716|NCT02120833|B1|Baseline|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73717|NCT02120833|P2|Participant Flow|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73718|NCT02120833|P1|Participant Flow|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73719|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73720|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73721|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73722|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73723|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73724|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73725|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73726|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73727|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73728|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73729|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73730|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73731|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73732|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73733|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73734|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73735|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73736|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73737|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73738|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73739|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73740|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73741|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73743|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73744|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73745|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73746|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73747|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73748|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73749|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73750|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73751|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73752|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73753|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73754|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73755|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73756|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73757|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73758|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73759|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73760|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73761|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73762|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73763|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73764|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73765|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73766|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73767|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73768|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73769|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73770|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73771|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73772|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73773|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73774|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73775|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73776|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73777|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73778|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73779|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73780|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73781|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73782|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73783|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73784|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73785|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73786|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73787|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73788|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73789|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73790|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73791|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73792|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73793|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73794|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73795|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73796|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73797|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73798|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73799|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73800|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73801|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73802|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73803|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73804|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73805|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73806|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73807|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73808|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73809|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73810|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73811|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73812|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73813|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73814|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73815|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73816|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73817|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73818|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73819|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73820|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73821|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73822|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73823|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73824|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73825|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73826|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73827|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73828|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73829|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73830|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73831|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73832|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73833|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73834|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73835|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73836|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73837|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73838|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73839|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73840|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73841|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73842|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73843|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73844|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73845|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73846|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73847|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73848|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73849|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73850|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73851|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73852|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73853|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73854|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73855|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73856|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73857|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73858|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73859|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73860|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73861|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73862|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73863|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73864|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73865|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73866|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73867|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73868|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73869|NCT02120833|E2|Reported Event|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
73870|NCT02120833|E1|Reported Event|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
73871|NCT02120664|B6|Baseline|Total|Total of all reporting groups
73872|NCT02120664|B5|Baseline|Young Healthy Controls (YHC)|Cognitively normal young subjects between 21 and 45 years of age (inclusive)
73873|NCT02120664|B4|Baseline|At Risk Elderly|Elderly patients, 75 years or older, who are known ApoE4 gene carriers, and cognitively normal
73874|NCT02120664|B3|Baseline|Mild Cognitive Impairment (MCI)|Patients with a clinical diagnosis of Mild Cognitive Impairment (MCI) and not dementia. Age is 60 years or greater
73875|NCT02120664|B2|Baseline|Possible AD|Patients meeting clinical criteria for dementia due to possible Alzheimer's Disease
73876|NCT02120664|B1|Baseline|Clincally Diagnosed AD|Patients meeting clinical criteria for dementia due to probable Alzheimer's Disease (AD)
73877|NCT02120664|P5|Participant Flow|Young Healthy Controls (YHC)|Cognitively normal young subjects between 21 and 45 years of age (inclusive)
73878|NCT02120664|P4|Participant Flow|At Risk Elderly|Elderly patients, 75 years or older, who are known ApoE4 gene carriers, and cognitively normal
73879|NCT02120664|P3|Participant Flow|Mild Cognitive Impairment (MCI)|Patients with a clinical diagnosis of Mild Cognitive Impairment (MCI) and not dementia. Age is 60 years or greater
73880|NCT02120664|P2|Participant Flow|Possible AD|Patients meeting clinical criteria for dementia due to possible Alzheimer's Disease
73881|NCT02120664|P1|Participant Flow|Clincally Diagnosed AD|Patients meeting clinical criteria for dementia due to probable Alzheimer's Disease (AD)
73882|NCT02120664|O2|Outcome|Florbetapir SUVR Variability|Variability of standardized uptake value ratio (SUVR) for florbetapir scans in young healthy controls
73883|NCT02120664|O1|Outcome|PiB SUVR Variability|Variability of standardized uptake value ratio (SUVR) for PiB scans in young healthy controls
73884|NCT02120664|O5|Outcome|Young Healthy Controls (YHC)|Cognitively normal young subjects between 21 and 45 years of age (inclusive)
73885|NCT02120664|O4|Outcome|At Risk Elderly|Elderly patients, 75 years or older, who are known ApoE4 gene carriers, and cognitively normal
73886|NCT02120664|O3|Outcome|Mild Cognitive Impairment (MCI)|Patients with a clinical diagnosis of Mild Cognitive Impairment (MCI) and not dementia. Age is 60 years or greater
73887|NCT02120664|O2|Outcome|Possible AD|Patients meeting clinical criteria for dementia due to possible Alzheimer's Disease
73888|NCT02120664|O1|Outcome|Clincally Diagnosed AD|Patients meeting clinical criteria for dementia due to probable Alzheimer's Disease (AD)
73889|NCT02120664|O5|Outcome|Young Healthy Controls (YHC)|Cognitively normal young subjects between 21 and 45 years of age (inclusive)
73890|NCT02120664|O4|Outcome|At Risk Elderly|Elderly patients, 75 years or older, who are known ApoE4 gene carriers, and cognitively normal
73891|NCT02120664|O3|Outcome|Mild Cognitive Impairment (MCI)|Patients with a clinical diagnosis of Mild Cognitive Impairment (MCI) and not dementia. Age is 60 years or greater
73892|NCT02120664|O2|Outcome|Possible AD|Patients meeting clinical criteria for dementia due to possible Alzheimer's Disease
73893|NCT02120664|O1|Outcome|Clincally Diagnosed AD|Patients meeting clinical criteria for dementia due to probable Alzheimer's Disease (AD)
73894|NCT02120664|E4|Reported Event|Total|Events following Florbetapir (florbetapir only and both)
73895|NCT02120664|E3|Reported Event|Both|Events occurring within 48 hours of both florbetapir and PiB scans
73896|NCT02120664|E2|Reported Event|PiB Only|Events occurring within 48 hours of PiB scans only
73897|NCT02120664|E1|Reported Event|Florbetapir Only|Events occurring within 48 hours following florbetapir scans only
73898|NCT02120625|B1|Baseline|Baseline Demographics|
73899|NCT02120625|P1|Participant Flow|Lumbar MB RFN|Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
73900|NCT02120625|O1|Outcome|Lumbar MB RFN|Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
73901|NCT02120625|O1|Outcome|Lumbar MB RFN|Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
73902|NCT02120625|O1|Outcome|Lumbar MB RFN|Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
73903|NCT02120625|O1|Outcome|Lumbar MB RFN|Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
73904|NCT02120625|E1|Reported Event|Lumbar MB RFN|Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
73905|NCT02120443|B1|Baseline|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.~ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
73906|NCT02120443|P1|Participant Flow|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.~ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
73907|NCT02120443|O1|Outcome|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.~ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
73908|NCT02120443|O1|Outcome|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.~ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
73909|NCT02120443|O1|Outcome|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.~ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
73910|NCT02120443|E1|Reported Event|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.~ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
73911|NCT02120417|B3|Baseline|Total|Total of all reporting groups
73912|NCT02120417|B2|Baseline|Treatment B - Capecitabine and Placebo|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
73913|NCT02120417|B1|Baseline|Treatment A - Capecitabine and Ruxolitinib|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
73914|NCT02120417|P2|Participant Flow|Treatment B - Capecitabine and Placebo|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
73915|NCT02120417|P1|Participant Flow|Treatment A - Capecitabine and Ruxolitinib|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
73916|NCT02120417|O2|Outcome|Treatment B - Capecitabine and Placebo|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
73917|NCT02120417|O1|Outcome|Treatment A - Capecitabine and Ruxolitinib|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
73918|NCT02120417|O2|Outcome|Treatment B - Capecitabine and Placebo|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
73919|NCT02120417|O1|Outcome|Treatment A - Capecitabine and Ruxolitinib|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
73920|NCT02120417|O2|Outcome|Treatment B - Capecitabine and Placebo|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
73921|NCT02120417|O1|Outcome|Treatment A - Capecitabine and Ruxolitinib|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
73922|NCT02120417|O2|Outcome|Treatment B - Capecitabine and Placebo|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
73923|NCT02120417|O1|Outcome|Treatment A - Capecitabine and Ruxolitinib|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
73924|NCT02120417|O2|Outcome|Treatment B - Capecitabine and Placebo|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
73925|NCT02120417|O1|Outcome|Treatment A - Capecitabine and Ruxolitinib|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
73926|NCT02120417|O2|Outcome|Treatment B - Capecitabine and Placebo|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
73927|NCT02120417|O1|Outcome|Treatment A - Capecitabine and Ruxolitinib|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
73964|NCT02120300|O3|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
73928|NCT02120417|O2|Outcome|Treatment B - Capecitabine and Placebo|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
73929|NCT02120417|O1|Outcome|Treatment A - Capecitabine and Ruxolitinib|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
73930|NCT02120417|E2|Reported Event|Treatment B - Capecitabine and Placebo|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
73931|NCT02120417|E1|Reported Event|Treatment A - Capecitabine and Ruxolitinib|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
73932|NCT02120300|B5|Baseline|Total|Total of all reporting groups
73933|NCT02120300|B4|Baseline|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
73934|NCT02120300|B3|Baseline|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
73935|NCT02120300|B2|Baseline|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
73936|NCT02120300|B1|Baseline|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
73937|NCT02120300|P4|Participant Flow|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
73938|NCT02120300|P3|Participant Flow|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
73939|NCT02120300|P2|Participant Flow|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
73940|NCT02120300|P1|Participant Flow|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
73941|NCT02120300|O3|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
73942|NCT02120300|O2|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
73943|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
73944|NCT02120300|O3|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
73945|NCT02120300|O2|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
73946|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
73947|NCT02120300|O4|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
73948|NCT02120300|O3|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
73949|NCT02120300|O2|Outcome|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
73950|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
73951|NCT02120300|O4|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
73952|NCT02120300|O3|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
73953|NCT02120300|O2|Outcome|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
73954|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
73955|NCT02120300|O4|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
73956|NCT02120300|O3|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
73957|NCT02120300|O2|Outcome|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
73958|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
73959|NCT02120300|O4|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
73960|NCT02120300|O3|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
73961|NCT02120300|O2|Outcome|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
73962|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
73963|NCT02120300|O4|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
74968|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
73965|NCT02120300|O2|Outcome|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
73966|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
73967|NCT02120300|O4|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
73968|NCT02120300|O3|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
73969|NCT02120300|O2|Outcome|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
73970|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
73971|NCT02120300|E4|Reported Event|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
73972|NCT02120300|E3|Reported Event|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
73973|NCT02120300|E2|Reported Event|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
73974|NCT02120300|E1|Reported Event|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
73975|NCT02120027|B3|Baseline|Total|Total of all reporting groups
73976|NCT02120027|B2|Baseline|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
73977|NCT02120027|B1|Baseline|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .~Ibodutant 10 mg: Oral tablet, to be given once daily."
73978|NCT02120027|P2|Participant Flow|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.~Placebo: Oral tablet (identical in appearance and weight to ibodutant tablets) to be given once daily."
73979|NCT02120027|P1|Participant Flow|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .~Ibodutant 10 mg: Oral tablet, to be given once daily."
73980|NCT02120027|O2|Outcome|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
73981|NCT02120027|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .~Ibodutant 10 mg: Oral tablet, to be given once daily."
73982|NCT02120027|O2|Outcome|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
73983|NCT02120027|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .~Ibodutant 10 mg: Oral tablet, to be given once daily."
73984|NCT02120027|O2|Outcome|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
73985|NCT02120027|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .~Ibodutant 10 mg: Oral tablet, to be given once daily."
73986|NCT02120027|O2|Outcome|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
73987|NCT02120027|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .~Ibodutant 10 mg: Oral tablet, to be given once daily."
73988|NCT02120027|O2|Outcome|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
73989|NCT02120027|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .~Ibodutant 10 mg: Oral tablet, to be given once daily."
73990|NCT02120027|E2|Reported Event|Placebo for 24-week Treatment|"Oral tablet to be given once daily for 24 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
73991|NCT02120027|E1|Reported Event|Ibodutant 10 mg for 24-week Treatment|"Oral tablet to be given once daily for 24 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
73992|NCT02120001|B3|Baseline|Total|Total of all reporting groups
74969|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
73993|NCT02120001|B2|Baseline|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
73994|NCT02120001|B1|Baseline|ETT Cleaning Maneuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
73995|NCT02120001|P2|Participant Flow|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
73996|NCT02120001|P1|Participant Flow|ETT Cleaning Maneuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
73997|NCT02120001|O2|Outcome|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
73998|NCT02120001|O1|Outcome|ETT Cleaning Maneuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
73999|NCT02120001|O2|Outcome|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
74000|NCT02120001|O1|Outcome|ETT Cleaning Maneuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
74001|NCT02120001|E2|Reported Event|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
74002|NCT02120001|E1|Reported Event|ETT Cleaning Maneuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
74003|NCT02119936|B1|Baseline|Heart Rate Variability Biofeedback|Intervention: Participants will be taught how to use the Heart Rate Variability Biofeedback tool (emWave) as a mechanism to reduce stress and anxiety, then use the tool, coupled with deep breathing exercises, to visualize their stress reduction.
74004|NCT02119936|P1|Participant Flow|Heart Rate Variability Biofeedback|Intervention: Participants will be taught how to use the Heart Rate Variability Biofeedback (HRVB) tool (emWave 2) as a mechanism to reduce stress and anxiety, then use the tool, coupled with deep breathing exercises, to visualize their stress reduction.
74005|NCT02119936|O1|Outcome|Heart Rate Variability Biofeedback|Intervention: Participants will be taught how to use the Heart Rate Variability Biofeedback tool (emWave) as a mechanism to reduce stress and anxiety, then use the tool, coupled with deep breathing exercises, to visualize their stress reduction.
74006|NCT02119936|O1|Outcome|Heart Rate Variability Biofeedback|Intervention: Participants will be taught how to use the Heart Rate Variability Biofeedback tool (emWave) as a mechanism to reduce stress and anxiety, then use the tool, coupled with deep breathing exercises, to visualize their stress reduction.
74007|NCT02119936|O1|Outcome|Heart Rate Variability Biofeedback|Intervention: Participants will be taught how to use the Heart Rate Variability Biofeedback tool (emWave) as a mechanism to reduce stress and anxiety, then use the tool, coupled with deep breathing exercises, to visualize their stress reduction.
74008|NCT02119936|O1|Outcome|Heart Rate Variability Biofeedback|Intervention: Participants will be taught how to use the Heart Rate Variability Biofeedback tool (emWave) as a mechanism to reduce stress and anxiety, then use the tool, coupled with deep breathing exercises, to visualize their stress reduction.
74009|NCT02119936|O1|Outcome|Heart Rate Variability Biofeedback|Intervention: Participants will be taught how to use the Heart Rate Variability Biofeedback tool (emWave) as a mechanism to reduce stress and anxiety, then use the tool, coupled with deep breathing exercises, to visualize their stress reduction.
74010|NCT02119936|O1|Outcome|Heart Rate Variability Biofeedback|Intervention: Participants will be taught how to use the Heart Rate Variability Biofeedback tool (emWave) as a mechanism to reduce stress and anxiety, then use the tool, coupled with deep breathing exercises, to visualize their stress reduction.
74011|NCT02119936|E1|Reported Event|Heart Rate Variability Biofeedback|Intervention: Participants will be taught how to use the Heart Rate Variability Biofeedback tool (emWave) as a mechanism to reduce stress and anxiety, then use the tool, coupled with deep breathing exercises, to visualize their stress reduction.
74012|NCT02119871|B3|Baseline|Total|Total of all reporting groups
74013|NCT02119871|B2|Baseline|Right Pleura Open|"Opening of right pleura and usage of left ventricular apical drainage.~Right Pleura Open: Right pleura open Left ventricular apical drainage"
74014|NCT02119871|B1|Baseline|Bilateral Open Pleurae|"Bilateral open pleurae and usage of right pulmonary vein drainage~Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage"
74015|NCT02119871|P2|Participant Flow|Right Pleura Open|"Opening of right pleura and usage of left ventricular apical drainage.~Right Pleura Open: Right pleura open Left ventricular apical drainage"
74016|NCT02119871|P1|Participant Flow|Bilateral Open Pleurae|"Bilateral open pleurae and usage of right pulmonary vein drainage~Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage"
74017|NCT02119871|O2|Outcome|Right Pleura Open|"Opening of right pleura and usage of left ventricular apical drainage.~Right Pleura Open: Right pleura open Left ventricular apical drainage"
74018|NCT02119871|O1|Outcome|Bilateral Open Pleurae|"Bilateral open pleurae and usage of right pulmonary vein drainage~Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage"
74019|NCT02119871|O2|Outcome|Right Pleura Open|"Opening of right pleura and usage of left ventricular apical drainage.~Right Pleura Open: Right pleura open Left ventricular apical drainage"
74020|NCT02119871|O1|Outcome|Bilateral Open Pleurae|"Bilateral open pleurae and usage of right pulmonary vein drainage~Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage"
74021|NCT02119871|O2|Outcome|Right Pleura Open|"Opening of right pleura and usage of left ventricular apical drainage.~Right Pleura Open: Right pleura open Left ventricular apical drainage"
74022|NCT02119871|O1|Outcome|Bilateral Open Pleurae|"Bilateral open pleurae and usage of right pulmonary vein drainage~Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage"
74023|NCT02119871|O2|Outcome|Right Pleura Open|"Opening of right pleura and usage of left ventricular apical drainage.~Right Pleura Open: Right pleura open Left ventricular apical drainage"
74024|NCT02119871|O1|Outcome|Bilateral Open Pleurae|"Bilateral open pleurae and usage of right pulmonary vein drainage~Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage"
74025|NCT02119871|O2|Outcome|Right Pleura Open|"Opening of right pleura and usage of left ventricular apical drainage.~Right Pleura Open: Right pleura open Left ventricular apical drainage"
74026|NCT02119871|O1|Outcome|Bilateral Open Pleurae|"Bilateral open pleurae and usage of right pulmonary vein drainage~Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage"
74027|NCT02119871|O2|Outcome|Right Pleura Open|"Opening of right pleura and usage of left ventricular apical drainage.~Right Pleura Open: Right pleura open Left ventricular apical drainage"
74028|NCT02119871|O1|Outcome|Bilateral Open Pleurae|"Bilateral open pleurae and usage of right pulmonary vein drainage~Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage"
74029|NCT02119871|O2|Outcome|Right Pleura Open|"Opening of right pleura and usage of left ventricular apical drainage.~Right Pleura Open: Right pleura open Left ventricular apical drainage"
74030|NCT02119871|O1|Outcome|Bilateral Open Pleurae|"Bilateral open pleurae and usage of right pulmonary vein drainage~Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage"
74031|NCT02119871|E2|Reported Event|Right Pleura Open|"Opening of right pleura and usage of left ventricular apical drainage.~Right Pleura Open: Right pleura open Left ventricular apical drainage"
74032|NCT02119871|E1|Reported Event|Bilateral Open Pleurae|"Bilateral open pleurae and usage of right pulmonary vein drainage~Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage"
74033|NCT02119676|B5|Baseline|Total|Total of all reporting groups
74034|NCT02119676|B4|Baseline|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74035|NCT02119676|B3|Baseline|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74036|NCT02119676|B2|Baseline|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74037|NCT02119676|B1|Baseline|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74038|NCT02119676|P4|Participant Flow|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74039|NCT02119676|P3|Participant Flow|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74040|NCT02119676|P2|Participant Flow|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74041|NCT02119676|P1|Participant Flow|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg twice a day (BID) continuous with regorafenib 160 mg once daily (QD) for the first 21 days of each 28-day cycle.
74042|NCT02119676|O4|Outcome|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74043|NCT02119676|O3|Outcome|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74044|NCT02119676|O2|Outcome|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74045|NCT02119676|O1|Outcome|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74046|NCT02119676|O4|Outcome|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74047|NCT02119676|O3|Outcome|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74048|NCT02119676|O2|Outcome|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74049|NCT02119676|O1|Outcome|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74050|NCT02119676|O4|Outcome|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74051|NCT02119676|O3|Outcome|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74052|NCT02119676|O2|Outcome|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74053|NCT02119676|O1|Outcome|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74054|NCT02119676|O4|Outcome|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74055|NCT02119676|O3|Outcome|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74056|NCT02119676|O2|Outcome|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74057|NCT02119676|O1|Outcome|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74058|NCT02119676|O4|Outcome|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74059|NCT02119676|O3|Outcome|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74060|NCT02119676|O2|Outcome|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74061|NCT02119676|O1|Outcome|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74062|NCT02119676|O4|Outcome|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74063|NCT02119676|O3|Outcome|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74064|NCT02119676|O2|Outcome|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74065|NCT02119676|O1|Outcome|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74066|NCT02119676|E4|Reported Event|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74067|NCT02119676|E3|Reported Event|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74068|NCT02119676|E2|Reported Event|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74069|NCT02119676|E1|Reported Event|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
74070|NCT02119663|B3|Baseline|Total|Total of all reporting groups
74071|NCT02119663|B2|Baseline|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74072|NCT02119663|B1|Baseline|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74073|NCT02119663|P2|Participant Flow|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74074|NCT02119663|P1|Participant Flow|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74075|NCT02119663|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74076|NCT02119663|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74077|NCT02119663|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74078|NCT02119663|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74079|NCT02119663|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74080|NCT02119663|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74081|NCT02119663|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74082|NCT02119663|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74083|NCT02119663|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74084|NCT02119663|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74085|NCT02119663|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74086|NCT02119663|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74087|NCT02119663|E2|Reported Event|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74088|NCT02119663|E1|Reported Event|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74089|NCT02119650|B3|Baseline|Total|Total of all reporting groups
74090|NCT02119650|B2|Baseline|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
74091|NCT02119650|B1|Baseline|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
74092|NCT02119650|P2|Participant Flow|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
74093|NCT02119650|P1|Participant Flow|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg twice daily (BID) oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
74113|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
78027|NCT02096900|O2|Outcome|Zolpidem|zolpidem was given orally 0.25mg/kg pre-operatively single dose
74094|NCT02119650|O2|Outcome|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
74095|NCT02119650|O1|Outcome|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
74096|NCT02119650|O2|Outcome|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
74097|NCT02119650|O1|Outcome|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
74098|NCT02119650|O2|Outcome|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
74099|NCT02119650|O1|Outcome|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
74100|NCT02119650|O2|Outcome|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
74101|NCT02119650|O1|Outcome|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
74102|NCT02119650|O2|Outcome|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
74103|NCT02119650|O1|Outcome|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
74104|NCT02119650|E2|Reported Event|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
74105|NCT02119650|E1|Reported Event|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
74106|NCT02119325|B1|Baseline|Overall Participants|
74107|NCT02119325|P2|Participant Flow|Sequence 2|Participants were administered with Placebo followed by Test. Test comprised of a fibre rich health food drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin). Placebo was a 'No fibre' health food drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
74108|NCT02119325|P1|Participant Flow|Sequence 1|Participants were adminisetered with Test followed by Placebo. Test comprised of a fibre rich health food drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin). Placebo was a 'No fibre' health food drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
74109|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
74110|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
74111|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
74112|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
74114|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
74115|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
74116|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
74117|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
74118|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
74119|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
74120|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
74121|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
74122|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
74123|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
74124|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
74125|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
74126|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
74127|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
74128|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
74129|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
74130|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
74131|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
74132|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
74133|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
74134|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
74135|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
74136|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
74137|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water
74138|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
74139|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
74140|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
74141|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
74142|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
74143|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
74144|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
74145|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
74146|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
74147|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
74148|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibe (resistant maltodextrin).
74149|NCT02119325|E2|Reported Event|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
74150|NCT02119325|E1|Reported Event|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
74151|NCT02119299|B1|Baseline|SMART Device|"Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device~SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device"
74152|NCT02119299|P1|Participant Flow|SMART Device|"Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device~SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device"
74153|NCT02119299|O1|Outcome|SMART Device|"Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device~SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device"
74154|NCT02119299|O1|Outcome|SMART Device|"Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device~SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device"
74155|NCT02119299|O1|Outcome|SMART Device|"Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device~SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device"
74156|NCT02119299|O1|Outcome|SMART Device|"Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device~SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device"
74157|NCT02119299|O1|Outcome|SMART Device|"Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device~SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device"
74158|NCT02119299|O1|Outcome|SMART Device|"Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device~SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device"
74159|NCT02119299|O1|Outcome|SMART Device|"Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device~SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device"
74160|NCT02119299|O1|Outcome|SMART Device|"Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device~SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device"
74161|NCT02119299|E1|Reported Event|SMART Device|"Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device~SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device"
74162|NCT02119286|B4|Baseline|Total|Total of all reporting groups
74163|NCT02119286|B3|Baseline|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
74164|NCT02119286|B2|Baseline|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
74165|NCT02119286|B1|Baseline|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
74166|NCT02119286|P3|Participant Flow|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
74167|NCT02119286|P2|Participant Flow|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
74168|NCT02119286|P1|Participant Flow|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
74169|NCT02119286|O3|Outcome|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
74170|NCT02119286|O2|Outcome|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
74171|NCT02119286|O1|Outcome|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
74172|NCT02119286|O3|Outcome|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
74173|NCT02119286|O2|Outcome|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
74174|NCT02119286|O1|Outcome|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
74175|NCT02119286|E3|Reported Event|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
74176|NCT02119286|E2|Reported Event|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
74177|NCT02119286|E1|Reported Event|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
74178|NCT02119104|B1|Baseline|Prevenar 13|Participants were vaccinated with Prevenar 13 as follows: for primary immunization, three doses of Prevenar 13 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
74179|NCT02119104|P1|Participant Flow|Prevenar 13|Participants were vaccinated with Prevenar 13 as follows: for primary immunization, three doses of Prevenar 13 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
74180|NCT02119104|O1|Outcome|Prevenar 13|Participants were vaccinated with Prevenar 13 as follows: for primary immunization, three doses of Prevenar 13 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
74181|NCT02119104|E1|Reported Event|Prevenar 13|Participants were vaccinated with Prevenar 13 as follows: for primary immunization, three doses of Prevenar 13 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
74182|NCT02118961|B3|Baseline|Total|Total of all reporting groups
74183|NCT02118961|B2|Baseline|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
74184|NCT02118961|B1|Baseline|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
74185|NCT02118961|P2|Participant Flow|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
74186|NCT02118961|P1|Participant Flow|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
74187|NCT02118961|O2|Outcome|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
74188|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
74189|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
74190|NCT02118961|O2|Outcome|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
74191|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
74192|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
74193|NCT02118961|O2|Outcome|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
74194|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
74195|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
74196|NCT02118961|O2|Outcome|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
74197|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
74198|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
74199|NCT02118961|O2|Outcome|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
74200|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
74201|NCT02118961|E2|Reported Event|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
74202|NCT02118961|E1|Reported Event|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
74203|NCT02118896|B11|Baseline|Total|Total of all reporting groups
74204|NCT02118896|B10|Baseline|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
74205|NCT02118896|B9|Baseline|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
74206|NCT02118896|B8|Baseline|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
74207|NCT02118896|B7|Baseline|PMR-EC-1105|"Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.~Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to"
74208|NCT02118896|B6|Baseline|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
74209|NCT02118896|B5|Baseline|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
74210|NCT02118896|B4|Baseline|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
74211|NCT02118896|B3|Baseline|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
74212|NCT02118896|B2|Baseline|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
74213|NCT02118896|B1|Baseline|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
74214|NCT02118896|P10|Participant Flow|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
74215|NCT02118896|P9|Participant Flow|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
74216|NCT02118896|P8|Participant Flow|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
74217|NCT02118896|P7|Participant Flow|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
74218|NCT02118896|P6|Participant Flow|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
74219|NCT02118896|P5|Participant Flow|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
74220|NCT02118896|P4|Participant Flow|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
74221|NCT02118896|P3|Participant Flow|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
74222|NCT02118896|P2|Participant Flow|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
74223|NCT02118896|P1|Participant Flow|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
74224|NCT02118896|O10|Outcome|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
74225|NCT02118896|O9|Outcome|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
74226|NCT02118896|O8|Outcome|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
74227|NCT02118896|O7|Outcome|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
74228|NCT02118896|O6|Outcome|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
74229|NCT02118896|O5|Outcome|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
74230|NCT02118896|O4|Outcome|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
74231|NCT02118896|O3|Outcome|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
74232|NCT02118896|O2|Outcome|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
74233|NCT02118896|O1|Outcome|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
74234|NCT02118896|O10|Outcome|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
74235|NCT02118896|O9|Outcome|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
74236|NCT02118896|O8|Outcome|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
74237|NCT02118896|O7|Outcome|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
74238|NCT02118896|O6|Outcome|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
74239|NCT02118896|O5|Outcome|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
74240|NCT02118896|O4|Outcome|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
74241|NCT02118896|O3|Outcome|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
74970|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
74242|NCT02118896|O2|Outcome|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
74243|NCT02118896|O1|Outcome|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
74244|NCT02118896|O10|Outcome|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
74245|NCT02118896|O9|Outcome|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
74246|NCT02118896|O8|Outcome|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
74247|NCT02118896|O7|Outcome|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
74248|NCT02118896|O6|Outcome|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
74249|NCT02118896|O5|Outcome|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
74250|NCT02118896|O4|Outcome|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
74251|NCT02118896|O3|Outcome|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
74252|NCT02118896|O2|Outcome|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
74253|NCT02118896|O1|Outcome|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
74254|NCT02118896|O10|Outcome|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study. There were no reported BCAR in subjects in the previous study PMR-EC-1210, Kaplan-Meier estimate not applicable.
74255|NCT02118896|O9|Outcome|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
74256|NCT02118896|O8|Outcome|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
74257|NCT02118896|O7|Outcome|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
74258|NCT02118896|O6|Outcome|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
74259|NCT02118896|O5|Outcome|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
74260|NCT02118896|O4|Outcome|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
74261|NCT02118896|O3|Outcome|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
74262|NCT02118896|O2|Outcome|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
74263|NCT02118896|O1|Outcome|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
74264|NCT02118896|O10|Outcome|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
74265|NCT02118896|O9|Outcome|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
74266|NCT02118896|O8|Outcome|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
74267|NCT02118896|O7|Outcome|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
74268|NCT02118896|O6|Outcome|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
74269|NCT02118896|O5|Outcome|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
74270|NCT02118896|O4|Outcome|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
74271|NCT02118896|O3|Outcome|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
74272|NCT02118896|O2|Outcome|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
74273|NCT02118896|O1|Outcome|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
74274|NCT02118896|O10|Outcome|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
74275|NCT02118896|O9|Outcome|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
74276|NCT02118896|O8|Outcome|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
74277|NCT02118896|O7|Outcome|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
74278|NCT02118896|O6|Outcome|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
74279|NCT02118896|O5|Outcome|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
74280|NCT02118896|O4|Outcome|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
74281|NCT02118896|O3|Outcome|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
74282|NCT02118896|O2|Outcome|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
74283|NCT02118896|O1|Outcome|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
74284|NCT02118896|E10|Reported Event|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
74285|NCT02118896|E9|Reported Event|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
74286|NCT02118896|E8|Reported Event|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
74287|NCT02118896|E7|Reported Event|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
74288|NCT02118896|E6|Reported Event|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
74289|NCT02118896|E5|Reported Event|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
74290|NCT02118896|E4|Reported Event|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
74291|NCT02118896|E3|Reported Event|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
74292|NCT02118896|E2|Reported Event|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
74293|NCT02118896|E1|Reported Event|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
74294|NCT02118831|B4|Baseline|Total|Total of all reporting groups
74295|NCT02118831|B3|Baseline|Ranibizumab|"Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.~Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care."
74296|NCT02118831|B2|Baseline|Bevacizumab|"Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.~Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care."
74297|NCT02118831|B1|Baseline|Aflibercept|"Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.~Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care."
74298|NCT02118831|P3|Participant Flow|Ranibizumab|"Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.~Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care."
74299|NCT02118831|P2|Participant Flow|Bevacizumab|"Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.~Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care."
74300|NCT02118831|P1|Participant Flow|Aflibercept|"Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.~Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care."
74301|NCT02118831|O3|Outcome|Ranibizumab|"Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.~Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care."
74302|NCT02118831|O2|Outcome|Bevacizumab|"Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.~Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care."
74303|NCT02118831|O1|Outcome|Aflibercept|"Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.~Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care."
74304|NCT02118831|O3|Outcome|Ranibizumab|"Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.~Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care."
74305|NCT02118831|O2|Outcome|Bevacizumab|"Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.~Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care."
74306|NCT02118831|O1|Outcome|Aflibercept|"Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.~Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care."
74307|NCT02118831|E3|Reported Event|Ranibizumab|"Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.~Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care."
74308|NCT02118831|E2|Reported Event|Bevacizumab|"Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.~Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care."
74309|NCT02118831|E1|Reported Event|Aflibercept|"Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.~Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care."
74310|NCT02118792|B3|Baseline|Total|Total of all reporting groups
74311|NCT02118792|B2|Baseline|AN2728 Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74406|NCT02118441|E1|Reported Event|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.~Direct Palpation-guided Radial Artery Catheter insertion"
74312|NCT02118792|B1|Baseline|AN2728 Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74313|NCT02118792|P2|Participant Flow|AN2728 Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74314|NCT02118792|P1|Participant Flow|AN2728 Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable atopic dermatitis (AD)-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74315|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74316|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74317|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74318|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74319|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74320|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74321|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74322|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74323|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74324|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74325|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74326|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74327|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74328|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74329|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74330|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74331|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74332|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74333|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74334|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74335|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74336|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74337|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74338|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74339|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74340|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74341|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74342|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74343|NCT02118792|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74344|NCT02118792|O1|Outcome|AN2728 Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74345|NCT02118792|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74346|NCT02118792|O1|Outcome|AN2728 Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74347|NCT02118792|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74348|NCT02118792|O1|Outcome|AN2728 Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74349|NCT02118792|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74350|NCT02118792|O1|Outcome|AN2728 Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74351|NCT02118792|E2|Reported Event|AN2728 Topical Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74352|NCT02118792|E1|Reported Event|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
74353|NCT02118766|B3|Baseline|Total|Total of all reporting groups
74354|NCT02118766|B2|Baseline|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
74355|NCT02118766|B1|Baseline|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
74356|NCT02118766|P2|Participant Flow|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
74357|NCT02118766|P1|Participant Flow|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
74358|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
74359|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
74360|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
74408|NCT02117934|B2|Baseline|Engerix-B|"1.0 mL Engerix-B~Engerix-B: Intramuscular injections at Week 0, Week 4, and Week 24"
74361|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
74362|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
74363|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
74364|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
74365|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
74366|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
74367|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
74368|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
74369|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
74370|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
74371|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
74372|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
74373|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
74374|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
74375|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
74376|NCT02118766|E2|Reported Event|Crisaborole (AN2728) Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
74377|NCT02118766|E1|Reported Event|Crisaborole (AN2728) Ointment, 2 Percent|Participants with mild to moderate AD applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
74378|NCT02118597|B1|Baseline|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
74379|NCT02118597|P1|Participant Flow|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
74380|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
74381|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
74382|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
74383|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
74384|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
74520|NCT02117544|E2|Reported Event|New MF|Includes all subjects/eyes exposed to New MF
74385|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
74386|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
74387|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
74388|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
74389|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
74390|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
74391|NCT02118597|E1|Reported Event|Triple Combination Therapy|Participants who demonstrated genotype 1 chronic hepatitis C infection and had a history of unsuccessful treatment with pegylated interferon (Peg-interferon) alfa + ribavirin, and who were subjected to receive a triple combination therapy with simeprevir or boceprevir plus peg-interferon alfa-2a and ribavirin were observed.
74392|NCT02118441|B3|Baseline|Total|Total of all reporting groups
74393|NCT02118441|B2|Baseline|Ultrasound|"Radial artery catheter insertion will be conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer will be used.~At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) will be used. Colour flow doppler may also be used to identify the artery if necessary.~Ultrasound-guided Radial Artery Catheter Insertion"
74394|NCT02118441|B1|Baseline|Direct Palpation|"Radial artery catheter insertion will be conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.~Direct Palpation-guided Radial Artery Catheter insertion"
74395|NCT02118441|P2|Participant Flow|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.~At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may have also been used to identify the artery if necessary.~Ultrasound-guided Radial Artery Catheter Insertion"
74396|NCT02118441|P1|Participant Flow|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.~Direct Palpation-guided Radial Artery Catheter insertion"
74397|NCT02118441|O2|Outcome|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.~At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may also have been used to identify the artery if necessary.~Ultrasound-guided Radial Artery Catheter Insertion"
74398|NCT02118441|O1|Outcome|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.~Direct Palpation-guided Radial Artery Catheter insertion"
74399|NCT02118441|O2|Outcome|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.~At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may have also been used to identify the artery if necessary.~Ultrasound-guided Radial Artery Catheter Insertion"
74400|NCT02118441|O1|Outcome|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.~Direct Palpation-guided Radial Artery Catheter insertion"
74401|NCT02118441|O2|Outcome|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.~At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may have also been used to identify the artery if necessary.~Ultrasound-guided Radial Artery Catheter Insertion"
74402|NCT02118441|O1|Outcome|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.~Direct Palpation-guided Radial Artery Catheter insertion"
74403|NCT02118441|O2|Outcome|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.~At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may have also been used to identify the artery if necessary.~Ultrasound-guided Radial Artery Catheter Insertion"
74404|NCT02118441|O1|Outcome|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.~Direct Palpation-guided Radial Artery Catheter insertion"
74405|NCT02118441|E2|Reported Event|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.~At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may also have been used to identify the artery if necessary.~Ultrasound-guided Radial Artery Catheter Insertion"
74407|NCT02117934|B3|Baseline|Total|Total of all reporting groups
74409|NCT02117934|B1|Baseline|HEPLISAV|"0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24"
74410|NCT02117934|P2|Participant Flow|Engerix-B|"1.0 mL Engerix-B~Engerix-B: Intramuscular injections at Week 0, Week 4, and Week 24"
74411|NCT02117934|P1|Participant Flow|HEPLISAV|"0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24"
74412|NCT02117934|O2|Outcome|Engerix-B|"1.0 mL Engerix-B~Engerix-B: Intramuscular injections at Week 0, Week 4, and Week 24"
74413|NCT02117934|O1|Outcome|HEPLISAV|"0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24"
74414|NCT02117934|O2|Outcome|Engerix-B|"1.0 mL Engerix-B~Engerix-B: Intramuscular injections at Week 0, Week 4, and Week 24"
74415|NCT02117934|O1|Outcome|HEPLISAV|"0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24"
74416|NCT02117934|E2|Reported Event|Engerix-B|"1.0 mL Engerix-B~Engerix-B: Intramuscular injections at Week 0, Week 4, and Week 24"
74417|NCT02117934|E1|Reported Event|HEPLISAV|"0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24"
74418|NCT02117687|B3|Baseline|Total|Total of all reporting groups
74419|NCT02117687|B2|Baseline|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74420|NCT02117687|B1|Baseline|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74421|NCT02117687|P2|Participant Flow|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74422|NCT02117687|P1|Participant Flow|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74423|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74424|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74425|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74426|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74427|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74428|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74429|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74430|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74431|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74432|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74433|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74434|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74435|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74436|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74437|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74438|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74439|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74440|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74441|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74442|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74443|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74444|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74445|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74521|NCT02117544|E1|Reported Event|Pre-treatment|Includes all enrolled subjects/eyes prior to exposure to the investigational products
74446|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74447|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74448|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74449|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74450|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74451|NCT02117687|E2|Reported Event|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74452|NCT02117687|E1|Reported Event|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
74453|NCT02117570|B4|Baseline|Total|Total of all reporting groups
74454|NCT02117570|B3|Baseline|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74455|NCT02117570|B2|Baseline|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74456|NCT02117570|B1|Baseline|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74457|NCT02117570|P3|Participant Flow|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74458|NCT02117570|P2|Participant Flow|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74459|NCT02117570|P1|Participant Flow|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74460|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74461|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74462|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74463|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74464|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74465|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74466|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74467|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74468|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74469|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74470|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74471|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74472|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74473|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74474|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74475|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74476|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74477|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74478|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74479|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74480|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74481|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74522|NCT02117479|B3|Baseline|Total|Total of all reporting groups
74482|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74483|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74484|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74485|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74486|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74487|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74488|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74489|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74490|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74491|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74492|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74493|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74494|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74495|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74496|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74497|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74498|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74499|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74500|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74501|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74502|NCT02117570|E6|Reported Event|Clostridium Difficile Vaccine, 200 µg (65-85 Year Age Cohort)|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74503|NCT02117570|E5|Reported Event|Clostridium Difficile Vaccine, 100 µg (65-85 Year Age Cohort)|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74504|NCT02117570|E4|Reported Event|Placebo (65-85 Year Age Cohort)|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74505|NCT02117570|E3|Reported Event|Clostridium Difficile Vaccine, 200 µg (50-64 Year Age Cohort)|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74506|NCT02117570|E2|Reported Event|Clostridium Difficile Vaccine, 100 µg (50-64 Year Age Cohort)|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74507|NCT02117570|E1|Reported Event|Placebo (50-64 Year Age Cohort)|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
74508|NCT02117544|B1|Baseline|Overall|AIR OPTIX® AQUA Multifocal and lotrafilcon B Multifocal (new design) contact lenses worn during Period 1 and Period 2 in a crossover assignment.
74509|NCT02117544|P2|Participant Flow|AOAMF, Then New MF|Lotrafilcon B multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses (new). Each product worn bilaterally for about 1 hour.
74510|NCT02117544|P1|Participant Flow|New MF, Then AOAMF|Lotrafilcon B multifocal contact lenses (new), followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally for about 1 hour.
74511|NCT02117544|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
74512|NCT02117544|O1|Outcome|New MF|Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour
74513|NCT02117544|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
74514|NCT02117544|O1|Outcome|New MF|Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour
74515|NCT02117544|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
74516|NCT02117544|O1|Outcome|New MF|Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour
74517|NCT02117544|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
74518|NCT02117544|O1|Outcome|New MF|Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour
74519|NCT02117544|E3|Reported Event|AOAMF|Includes all subjects/eyes exposed to AOAMF
74523|NCT02117479|B2|Baseline|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74524|NCT02117479|B1|Baseline|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74525|NCT02117479|P2|Participant Flow|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74526|NCT02117479|P1|Participant Flow|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74527|NCT02117479|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74528|NCT02117479|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74529|NCT02117479|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74530|NCT02117479|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74531|NCT02117479|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74532|NCT02117479|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74533|NCT02117479|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74534|NCT02117479|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74535|NCT02117479|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74536|NCT02117479|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74537|NCT02117479|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74538|NCT02117479|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74539|NCT02117479|E2|Reported Event|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74540|NCT02117479|E1|Reported Event|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
74541|NCT02117414|B3|Baseline|Total|Total of all reporting groups
74542|NCT02117414|B2|Baseline|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
74543|NCT02117414|B1|Baseline|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
74544|NCT02117414|P2|Participant Flow|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
74545|NCT02117414|P1|Participant Flow|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
74546|NCT02117414|O2|Outcome|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
74547|NCT02117414|O1|Outcome|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
74548|NCT02117414|O2|Outcome|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
74549|NCT02117414|O1|Outcome|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
74550|NCT02117414|O2|Outcome|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
74551|NCT02117414|O1|Outcome|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
74552|NCT02117414|O2|Outcome|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
74553|NCT02117414|O1|Outcome|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
74554|NCT02117414|O1|Outcome|Implanted Subjects|All subjects who are successfully implanted with the Evera MRI Study System or have an implant attempt will be included in the analysis.
74587|NCT02117193|E1|Reported Event|Alcohol Intake + Normal Sleep|1 g/kg of etanol combined with 8 hours of normal sleep
74555|NCT02117414|O2|Outcome|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
74556|NCT02117414|O1|Outcome|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
74557|NCT02117414|O2|Outcome|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
74558|NCT02117414|O1|Outcome|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
74559|NCT02117414|O1|Outcome|MRI Group|All subjects successfully implanted with the Evera MRI Study System who have an MRI scan at the MRI/waiting period visit and have completed their one month post-MRI scan follow-up, (or a later follow-up), or have had an MRI-related event without completion of their one-month post-MRI scan follow-up will be included in the analysis
74560|NCT02117414|E2|Reported Event|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
74561|NCT02117414|E1|Reported Event|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
74562|NCT02117310|B1|Baseline|ICG-Angiography With Administered ICG|Indocyanine green: ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.
74563|NCT02117310|P1|Participant Flow|ICG-Angiography With Administered ICG|Indocyanine green: ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.
74564|NCT02117310|O1|Outcome|ICG-Angiography With Administered ICG|Indocyanine green: ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.
74565|NCT02117310|E1|Reported Event|ICG-Angiography With Administered ICG|Indocyanine green: ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.
74566|NCT02117193|B1|Baseline|All Study Participants|Received Alcohol intake + Normal Sleep Received Alcohol intake + Sleep Deprivation Received Placebo intake + Normal Sleep Received Placebo intake + Sleep Deprivation
74567|NCT02117193|P1|Participant Flow|All Study Participants|This is a cross-over study.
74568|NCT02117193|O4|Outcome|Sequence 4|"Placebo intake + Sleep deprivation~Placebo intake: The subjects will be drink beer (zero alcohol, in the same volume that alcohol intake) before sleep.~Sleep deprivation: One night of sleep deprivation (8h)"
74569|NCT02117193|O3|Outcome|Sequence 3|"Placebo intake + Normal Sleep~Placebo intake: The subjects will be drink beer (zero alcohol, in the same volume that alcohol intake) before sleep.~Normal sleep: One night of normal sleep (8h)"
74570|NCT02117193|O2|Outcome|Sequence 2|"Alcohol intake + Sleep Deprivation~Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.~Sleep deprivation: One night of sleep deprivation (8h)"
74571|NCT02117193|O1|Outcome|Sequence 1|"Alcohol intake + Normal Sleep~Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.~Normal sleep: One night of normal sleep (8h)"
74572|NCT02117193|O4|Outcome|Placebo Intake + Sleep Deprivation|Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of sleep deprivation
74573|NCT02117193|O3|Outcome|Placebo Intake + Normal Sleep|Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of normal sleep
74574|NCT02117193|O2|Outcome|Alcohol Intake + Sleep Deprivation|1g/kg of alcohol (beer) combined with 8 hours of sleep deprivation
74575|NCT02117193|O1|Outcome|Alcohol Intake + Normal Sleep|1g/kg of alcohol (beer) combined with 8 hours of normal sleep
74576|NCT02117193|O4|Outcome|Sequence 4|"Placebo intake + Sleep deprivation~Placebo intake: The subjects will be drink beer (zero alcohol) before sleep.~Sleep deprivation: One night of sleep deprivation (8h)"
74577|NCT02117193|O3|Outcome|Sequence 3|"Placebo intake + Normal Sleep~Placebo intake: The subjects will be drink beer (zero alcohol) before sleep.~Normal sleep: One night of normal sleep (8h)"
74578|NCT02117193|O2|Outcome|Sequence 2|"Alcohol intake + Sleep deprivation~Alcohol intake: The subjects will be drink beer (1g/kg ethanol) before sleep.~Sleep deprivation: One night of sleep deprivation (8h)"
74579|NCT02117193|O1|Outcome|Sequence 1|"Alcohol intake + Normal Sleep~Alcohol intake: The subjects will be drink beer (1g/kg ethanol) before sleep.~Normal sleep: One night of normal sleep (8h)"
74580|NCT02117193|O4|Outcome|Sequence 4|"Placebo intake + Sleep deprivation~Placebo intake: The subjects will be drink beer (zero alcohol) before sleep.~Sleep deprivation: One night of sleep deprivation (8h)"
74581|NCT02117193|O3|Outcome|Sequence 3|"Placebo intake + Normal Sleep~Placebo intake: The subjects will be drink beer (zero alcohol) before sleep.~Normal sleep: One night of normal sleep (8h)"
74582|NCT02117193|O2|Outcome|Sequence 2|"Alcohol intake + Sleep deprivation~Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.~Sleep deprivation: One night of sleep deprivation (8h)"
74583|NCT02117193|O1|Outcome|Sequence 1|"Alcohol intake + Normal Sleep~Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.~Normal sleep: One night of normal sleep (8h)"
74584|NCT02117193|E4|Reported Event|Placebo Intake + Sleep Deprivation|Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of sleep deprivation
74585|NCT02117193|E3|Reported Event|Placebo Intake + Normal Sleep|Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of normal sleep
74586|NCT02117193|E2|Reported Event|Alcohol Intake + Sleep Deprivation|1 g/kg of etanol combined with 8 hours of sleep deprivation
74588|NCT02117050|B1|Baseline|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 mcg in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
74589|NCT02117050|P1|Participant Flow|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
74590|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
74591|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
74592|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
74593|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 mcg in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
74594|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
74595|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
74596|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
74597|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 mcg in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
74598|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 mcg in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
74599|NCT02117050|E1|Reported Event|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 mcg in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
74600|NCT02116972|B4|Baseline|Total|Total of all reporting groups
74601|NCT02116972|B3|Baseline|Normal Saline|"Single intra-articular injection~Normal saline: Single intra-articular injection"
74602|NCT02116972|B2|Baseline|FX006 32 mg|"Single intra-articular injection~FX006: Single intra-articular injection"
74603|NCT02116972|B1|Baseline|FX006 16 mg|"Single intra-articular injection~FX006: Single intra-articular injection"
74604|NCT02116972|P3|Participant Flow|Placebo|100 subjects received normal saline as a single 5 mL IA injection
74605|NCT02116972|P2|Participant Flow|FX006 32 mg|104 subjects received FX006 32 mg a single 5 mL IA injection
74606|NCT02116972|P1|Participant Flow|FX006 16 mg|102 subjects received FX006 16 mg a single 5 mL IA injection
74607|NCT02116972|O2|Outcome|Placebo|Normal Saline: Single 5 mL IA injection
74608|NCT02116972|O1|Outcome|FX006 32 mg|FX006: Single 5 mL IA injection
74609|NCT02116972|O2|Outcome|Placebo|Normal Saline: Single 5 mL IA injection
74610|NCT02116972|O1|Outcome|FX006 32 mg|FX006: Single 5 mL IA injection
74611|NCT02116972|O2|Outcome|Placebo|Normal Saline: Single 5 mL IA injection
74612|NCT02116972|O1|Outcome|FX006 32 mg|FX006: Single 5 mL IA injection
74613|NCT02116972|O2|Outcome|Placebo|Normal Saline: Single 5 mL IA injection
74614|NCT02116972|O1|Outcome|FX006 32 mg|FX006: Single 5 mL IA injection
74615|NCT02116972|O3|Outcome|Placebo|Normal Saline: Single 5 mL IA injection
74616|NCT02116972|O2|Outcome|FX006 32 mg|FX006: Single 5 mL IA injection
74617|NCT02116972|O1|Outcome|FX006 16 mg|FX006: Single 5 mL IA injection
74618|NCT02116972|O2|Outcome|Placebo|Normal Saline: Single 5 mL IA injection
74619|NCT02116972|O1|Outcome|FX006 16 mg|FX006: Single 5 mL IA injection
74620|NCT02116972|O2|Outcome|Placebo|Normal Saline: Single 5 mL IA injection
74621|NCT02116972|O1|Outcome|FX006 16 mg|FX006: Single 5 mL IA injection
74622|NCT02116972|O2|Outcome|Placebo|Normal Saline: Single 5 mL IA injection
74623|NCT02116972|O1|Outcome|FX006 32 mg|FX006: Single 5 mL IA injection
74624|NCT02116972|O2|Outcome|Placebo|Normal Saline: Single 5 mL IA injection
74625|NCT02116972|O1|Outcome|FX006 32 mg|FX006: Single 5 mL IA injection
74626|NCT02116972|O2|Outcome|Placebo|Normal Saline: Single 5 mL IA injection
74627|NCT02116972|O1|Outcome|FX006 32 mg|FX006: Single 5 mL IA injection
74628|NCT02116972|O2|Outcome|Placebo|Normal Saline: Single 5 mL IA injection
74629|NCT02116972|O1|Outcome|FX006 32 mg|FX006: Single 5 mL IA injection
74630|NCT02116972|O2|Outcome|Placebo|Normal Saline: Single 5 mL IA injection
74631|NCT02116972|O1|Outcome|FX006 32 mg|FX006: Single 5 mL IA injection
74632|NCT02116972|E3|Reported Event|Placebo|Single 5 mL IA injection
74633|NCT02116972|E2|Reported Event|FX006 32 mg|Single 5 mL IA injection
74636|NCT02116803|B2|Baseline|Dovitinib + Fulvestrant|Participants were given dovitinib and fulvestrant coadministration starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were at the discretion of the investigator based on guidance provided in the protocol and IB.
74637|NCT02116803|B1|Baseline|Dovitinib|Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB).
74638|NCT02116803|P2|Participant Flow|Dovitinib + Fulvestrant|Participants were given dovitinib and fulvestrant coadministration starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were at the discretion of the investigator based on guidance provided in the protocol and IB.
74639|NCT02116803|P1|Participant Flow|Dovitinib|Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB).
74640|NCT02116803|O2|Outcome|Dovitinib + Fulvestrant|Participants were given dovitinib and fulvestrant coadministration starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were at the discretion of the investigator based on guidance provided in the protocol and IB.
74641|NCT02116803|O1|Outcome|Dovitinib|Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB).
74642|NCT02116803|E2|Reported Event|Dovitinib+Fulvestrant|Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB).
74643|NCT02116803|E1|Reported Event|Dovitinib|Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB).
74644|NCT02116621|B3|Baseline|Total|Total of all reporting groups
74645|NCT02116621|B2|Baseline|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74646|NCT02116621|B1|Baseline|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74647|NCT02116621|P2|Participant Flow|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74648|NCT02116621|P1|Participant Flow|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74649|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74650|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74651|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74652|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74653|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74654|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74655|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74656|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74657|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74740|NCT02116582|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
74658|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74659|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74660|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74661|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74662|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74663|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74664|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74665|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74666|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74667|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74668|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74669|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74670|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74671|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74672|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74673|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74674|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74675|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74676|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74677|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74741|NCT02116582|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
74788|NCT02116361|O1|Outcome|Placebo (Normal Saline) for onabotulinumtoxinA 30 U|Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
74678|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74679|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74680|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74681|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74682|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74683|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74684|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74685|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74686|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74687|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74688|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74689|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74690|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74691|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74692|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74693|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74694|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74695|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74696|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74697|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74742|NCT02116582|E1|Reported Event|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
74743|NCT02116530|B3|Baseline|Total|Total of all reporting groups
74789|NCT02116361|O4|Outcome|onabotulinumtoxinA 50 U|OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
74698|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74699|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74700|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74701|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74702|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74703|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74704|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74705|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74706|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74707|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74708|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74709|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74710|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74711|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74712|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74713|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74714|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74715|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74716|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74717|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74784|NCT02116361|O1|Outcome|Placebo (Normal Saline) for onabotulinumtoxinA 30 U|Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
74785|NCT02116361|O4|Outcome|onabotulinumtoxinA 50 U|OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
74917|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
74718|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74719|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74720|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74721|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74722|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74723|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74724|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74725|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74726|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74727|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74728|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74729|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74730|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74731|NCT02116621|O2|Outcome|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74732|NCT02116621|O1|Outcome|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74733|NCT02116621|E2|Reported Event|Control-Usual Care|Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
74734|NCT02116621|E1|Reported Event|Trialist Intervention|"Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.~Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.~smartphone"
74735|NCT02116582|B1|Baseline|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
74736|NCT02116582|P1|Participant Flow|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
74737|NCT02116582|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
74738|NCT02116582|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
74739|NCT02116582|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
74744|NCT02116530|B2|Baseline|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~placebo"
74745|NCT02116530|B1|Baseline|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
74746|NCT02116530|P2|Participant Flow|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~placebo"
74747|NCT02116530|P1|Participant Flow|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
74748|NCT02116530|O2|Outcome|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~placebo"
74749|NCT02116530|O1|Outcome|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
74750|NCT02116530|O2|Outcome|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~placebo"
74751|NCT02116530|O1|Outcome|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
74752|NCT02116530|O2|Outcome|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~placebo"
74753|NCT02116530|O1|Outcome|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
74754|NCT02116530|O2|Outcome|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~placebo"
74786|NCT02116361|O3|Outcome|Placebo (Normal Saline) for onabotulinumtoxinA 50 U|Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
74755|NCT02116530|O1|Outcome|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
74756|NCT02116530|O2|Outcome|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~placebo"
74757|NCT02116530|O1|Outcome|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
74758|NCT02116530|E2|Reported Event|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~placebo"
74759|NCT02116530|E1|Reported Event|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
74760|NCT02116361|B5|Baseline|Total|Total of all reporting groups
74761|NCT02116361|B4|Baseline|onabotulinumtoxinA 30 U|OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
74762|NCT02116361|B3|Baseline|Placebo (Normal Saline) for onabotulinumtoxinA 30 U|Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
74763|NCT02116361|B2|Baseline|onabotulinumtoxinA 50 U|OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
74764|NCT02116361|B1|Baseline|Placebo (Normal Saline) for onabotulinumtoxinA 50 U|Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
74765|NCT02116361|P4|Participant Flow|onabotulinumtoxinA 30 U|OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
74766|NCT02116361|P3|Participant Flow|Placebo (Normal Saline) for onabotulinumtoxinA 30 U|Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
74767|NCT02116361|P2|Participant Flow|onabotulinumtoxinA 50 U|OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
74768|NCT02116361|P1|Participant Flow|Placebo (Normal Saline) for onabotulinumtoxinA 50 U|Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
74769|NCT02116361|O4|Outcome|onabotulinumtoxinA 50 U|OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
74770|NCT02116361|O3|Outcome|Placebo (Normal Saline) for onabotulinumtoxinA 50 U|Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
74771|NCT02116361|O2|Outcome|onabotulinumtoxinA 30 U|OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
74772|NCT02116361|O1|Outcome|Placebo (Normal Saline) for onabotulinumtoxinA 30 U|Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
74773|NCT02116361|O4|Outcome|onabotulinumtoxinA 50 U|OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
74774|NCT02116361|O3|Outcome|Placebo (Normal Saline) for onabotulinumtoxinA 50 U|Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
74775|NCT02116361|O2|Outcome|onabotulinumtoxinA 30 U|OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
74776|NCT02116361|O1|Outcome|Placebo (Normal Saline) for onabotulinumtoxinA 30 U|Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
74777|NCT02116361|O4|Outcome|onabotulinumtoxinA 50 U|OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
74778|NCT02116361|O3|Outcome|Placebo (Normal Saline) for onabotulinumtoxinA 50 U|Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
74779|NCT02116361|O2|Outcome|onabotulinumtoxinA 30 U|OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
74780|NCT02116361|O1|Outcome|Placebo (Normal Saline) for onabotulinumtoxinA 30 U|Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
74781|NCT02116361|O4|Outcome|onabotulinumtoxinA 50 U|OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
74782|NCT02116361|O3|Outcome|Placebo (Normal Saline) for onabotulinumtoxinA 50 U|Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
74783|NCT02116361|O2|Outcome|onabotulinumtoxinA 30 U|OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
74787|NCT02116361|O2|Outcome|onabotulinumtoxinA 30 U|OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
74790|NCT02116361|O3|Outcome|Placebo (Normal Saline) for onabotulinumtoxinA 50 U|Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
74791|NCT02116361|O2|Outcome|onabotulinumtoxinA 30 U|OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
74792|NCT02116361|O1|Outcome|Placebo (Normal Saline) for onabotulinumtoxinA 30 U|Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
74793|NCT02116361|E4|Reported Event|onabotulinumtoxinA 30 U|OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
74794|NCT02116361|E3|Reported Event|Placebo (Normal Saline) for onabotulinumtoxinA 30 U|Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
74795|NCT02116361|E2|Reported Event|onabotulinumtoxinA 50 U|OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
74796|NCT02116361|E1|Reported Event|Placebo (Normal Saline) for onabotulinumtoxinA 50 U|Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
74797|NCT02116322|B1|Baseline|Pancreatic Mass|"Patients with pancreatic mass presenting for EUS-FNA~EUS-FNA with Corkscrew technique~Expect 19 G Flex needle"
74798|NCT02116322|P1|Participant Flow|Pancreatic Mass|"Patients with pancreatic mass presenting for EUS-FNA~EUS-FNA with Corkscrew technique~Expect 19 G Flex needle"
74799|NCT02116322|O1|Outcome|Pancreatic Mass|"Patients with pancreatic mass presenting for EUS-FNA~EUS-FNA with Corkscrew technique~Expect 19 G Flex needle"
74800|NCT02116322|O1|Outcome|Pancreatic Mass|"Patients with pancreatic mass presenting for EUS-FNA~EUS-FNA with Corkscrew technique~Expect 19 G Flex needle"
74801|NCT02116322|E1|Reported Event|Pancreatic Mass|"Patients with pancreatic mass presenting for EUS-FNA~EUS-FNA with Corkscrew technique~Expect 19 G Flex needle"
74802|NCT02116309|B3|Baseline|Total|Total of all reporting groups
74803|NCT02116309|B2|Baseline|Rectal Indomethacin Plus Papillary Spray of Epinephrine|"Patients in this group will receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla and surrounding regions of edema, over a period of 1 minute using any ERCP cannulation catheter, at the end of procedure, just before the withdrawal of endoscope; followed by 100 mg of rectal indomethacin.~Rectal Indomethacin~Epinephrine"
74804|NCT02116309|B1|Baseline|Rectal Indomethacin Only|"Patients in this group will receive 20 ml of normal saline sprayed on the duodenal papilla and surrounding regions of edema, over a period of 1 minute using any ERCP cannulation catheter, at the end of procedure, just before the withdrawal of endoscope; followed by 100 mg of rectal indomethacin.~Rectal Indomethacin"
74805|NCT02116309|P2|Participant Flow|Rectal Indomethacin Plus Papillary Spray of Epinephrine|"Patients in this group will receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla and surrounding regions of edema, over a period of 1 minute using any ERCP cannulation catheter, at the end of procedure, just before the withdrawal of endoscope; followed by 100 mg of rectal indomethacin.~Rectal Indomethacin~Epinephrine"
74806|NCT02116309|P1|Participant Flow|Rectal Indomethacin Only|"Patients in this group will receive 20 ml of normal saline sprayed on the duodenal papilla and surrounding regions of edema, over a period of 1 minute using any ERCP cannulation catheter, at the end of procedure, just before the withdrawal of endoscope; followed by 100 mg of rectal indomethacin.~Rectal Indomethacin"
74807|NCT02116309|O2|Outcome|Rectal Indomethacin Plus Papillary Spray of Epinephrine|"Patients in this group will receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla and surrounding regions of edema, over a period of 1 minute using any ERCP cannulation catheter, at the end of procedure, just before the withdrawal of endoscope; followed by 100 mg of rectal indomethacin.~Rectal Indomethacin~Epinephrine"
74808|NCT02116309|O1|Outcome|Rectal Indomethacin Only|"Patients in this group will receive 20 ml of normal saline sprayed on the duodenal papilla and surrounding regions of edema, over a period of 1 minute using any ERCP cannulation catheter, at the end of procedure, just before the withdrawal of endoscope; followed by 100 mg of rectal indomethacin.~Rectal Indomethacin"
74809|NCT02116309|O2|Outcome|Rectal Indomethacin Plus Papillary Spray of Epinephrine|"Patients in this group will receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla and surrounding regions of edema, over a period of 1 minute using any ERCP cannulation catheter, at the end of procedure, just before the withdrawal of endoscope; followed by 100 mg of rectal indomethacin.~Rectal Indomethacin~Epinephrine"
74810|NCT02116309|O1|Outcome|Rectal Indomethacin Only|"Patients in this group will receive 20 ml of normal saline sprayed on the duodenal papilla and surrounding regions of edema, over a period of 1 minute using any ERCP cannulation catheter, at the end of procedure, just before the withdrawal of endoscope; followed by 100 mg of rectal indomethacin.~Rectal Indomethacin"
74811|NCT02116309|E2|Reported Event|Rectal Indomethacin Plus Papillary Spray of Epinephrine|"Patients in this group will receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla and surrounding regions of edema, over a period of 1 minute using any ERCP cannulation catheter, at the end of procedure, just before the withdrawal of endoscope; followed by 100 mg of rectal indomethacin.~Rectal Indomethacin~Epinephrine"
74812|NCT02116309|E1|Reported Event|Rectal Indomethacin Only|"Patients in this group will receive 20 ml of normal saline sprayed on the duodenal papilla and surrounding regions of edema, over a period of 1 minute using any ERCP cannulation catheter, at the end of procedure, just before the withdrawal of endoscope; followed by 100 mg of rectal indomethacin.~Rectal Indomethacin"
74813|NCT02115984|B3|Baseline|Total|Total of all reporting groups
74814|NCT02115984|B2|Baseline|Chemotherapy & Placebo|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
74815|NCT02115984|B1|Baseline|Chemotherapy & Panagen|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
74816|NCT02115984|P2|Participant Flow|Chemotherapy & Placebo|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
74817|NCT02115984|P1|Participant Flow|Chemotherapy & Panagen|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
74818|NCT02115984|O2|Outcome|Chemotherapy & Placebo|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
74819|NCT02115984|O1|Outcome|Chemotherapy & Panagen|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
74820|NCT02115984|E2|Reported Event|Chemotherapy & Placebo|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
74821|NCT02115984|E1|Reported Event|Chemotherapy & Panagen|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
74822|NCT02115815|B8|Baseline|Total|Total of all reporting groups
74823|NCT02115815|B7|Baseline|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74824|NCT02115815|B6|Baseline|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
74825|NCT02115815|B5|Baseline|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74826|NCT02115815|B4|Baseline|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
74827|NCT02115815|B3|Baseline|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74828|NCT02115815|B2|Baseline|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
74829|NCT02115815|B1|Baseline|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
74830|NCT02115815|P7|Participant Flow|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74831|NCT02115815|P6|Participant Flow|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
74832|NCT02115815|P5|Participant Flow|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74833|NCT02115815|P4|Participant Flow|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
74834|NCT02115815|P3|Participant Flow|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74835|NCT02115815|P2|Participant Flow|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
74836|NCT02115815|P1|Participant Flow|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
74837|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74838|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
74839|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74840|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
74965|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
74841|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74842|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
74843|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
74844|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74845|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
74846|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74847|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
74848|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74849|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
74850|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
74851|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74852|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
74853|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74854|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
74855|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74856|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
74857|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
74858|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74859|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
74860|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74861|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
74862|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74863|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
74864|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
74865|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74866|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
74867|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74868|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
74869|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74870|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
74871|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
74872|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74873|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
74874|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74875|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
74876|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74877|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
74878|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
74966|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
74879|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74880|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
74881|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74882|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
74883|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74884|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
74885|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
74886|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74887|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
74888|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74889|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
74890|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74891|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
74892|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
74893|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74894|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
74895|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74896|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
74897|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74898|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
74899|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
74900|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74901|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
74902|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74903|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
74904|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74905|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
74906|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
74907|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74908|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
74909|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74910|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
74911|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74912|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
74913|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
74914|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74915|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
74916|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74967|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
74918|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74919|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
74920|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
74921|NCT02115815|E7|Reported Event|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74922|NCT02115815|E6|Reported Event|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
74923|NCT02115815|E5|Reported Event|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74924|NCT02115815|E4|Reported Event|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
74925|NCT02115815|E3|Reported Event|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
74926|NCT02115815|E2|Reported Event|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
74927|NCT02115815|E1|Reported Event|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
74928|NCT02115646|B1|Baseline|Fractionated CO2 Laser Treatment|"Fractionated carbon dioxide laser~Fractionated carbon dioxide laser: patients received serial fractionated CO2 laser treatments for a total fo 3 treatments."
74929|NCT02115646|P1|Participant Flow|Fractionated CO2 Laser Treatment|"Fractionated carbon dioxide laser~Fractionated carbon dioxide laser: patients received serial fractionated CO2 laser treatments for a total fo 3 treatments."
74930|NCT02115646|O2|Outcome|15-months|Characteristics of study population at 15-months.
74931|NCT02115646|O1|Outcome|Baseline|Characteristics of study population at baseline.
74932|NCT02115646|O2|Outcome|15-months|Characteristics of study population at conclusion of study
74933|NCT02115646|O1|Outcome|Baseline|Characteristics of study population at baseline
74934|NCT02115646|O2|Outcome|15-months|Characteristics of study population at 15-months
74935|NCT02115646|O1|Outcome|Baseline|Characteristics of study population at baseline.
74936|NCT02115646|O2|Outcome|15-months|Characteristics of study population at conclusion of study
74937|NCT02115646|O1|Outcome|Baseline|Characteristics of study population at baseline
74938|NCT02115646|O2|Outcome|15-months|Characteristics of study population at conclusion of study.
74939|NCT02115646|O1|Outcome|Baseline|Characteristics of study population at baseline.
74940|NCT02115646|E1|Reported Event|Fractionated CO2 Laser Treatment|"Fractionated carbon dioxide laser~Fractionated carbon dioxide laser: patients received serial fractionated CO2 laser treatments for a total fo 3 treatments."
74941|NCT02115581|B3|Baseline|Total|Total of all reporting groups
74942|NCT02115581|B2|Baseline|Placebo|known cases of idiopathic dilated cardiomyopathy who received the placebo
74943|NCT02115581|B1|Baseline|Conezyme Q10|known cases of idiopathic dilated cardiomyopathy who received Co Q10
74944|NCT02115581|P2|Participant Flow|Placebo|Known cases of idiopathic dilated cardiomyopathy who received the placebo
74945|NCT02115581|P1|Participant Flow|Coenzyme Q10|Known cases of idiopathic dilated cardiomyopathy who received Co Q10
74946|NCT02115581|O2|Outcome|Placebo|Known cases of idiopathic dilated cardiomyopathy who received the placebo
74947|NCT02115581|O1|Outcome|Conezyme Q10|Known cases of idiopathic dilated cardiomyopathy who received Co Q10
74948|NCT02115581|O2|Outcome|Placebo|Known cases of idiopathic dilated cardiomyopathy who received the placebo
74949|NCT02115581|O1|Outcome|Conezyme Q10|Known cases of idiopathic dilated cardiomyopathy who received Co Q10
74950|NCT02115581|O2|Outcome|Placebo|Known cases of idiopathic dilated cardiomyopathy who received the placebo
74951|NCT02115581|O1|Outcome|Conezyme Q10|Known cases of idiopathic dilated cardiomyopathy who received Co Q10
74952|NCT02115581|E2|Reported Event|Placebo (Control Group)|"Known cases of idiopathic dilated cardiomyopathy~Placebo: dose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient’s tolerance"
74953|NCT02115581|E1|Reported Event|Coenzyme Q10 (Study Group)|"Known cases of idiopathic dilated cardiomyopathy~Coenzyme Q10: dose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient’s tolerance"
74954|NCT02115321|B3|Baseline|Total|Total of all reporting groups
74955|NCT02115321|B2|Baseline|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
74956|NCT02115321|B1|Baseline|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
74957|NCT02115321|P2|Participant Flow|Part A: NC GZR 100 mg + EBR 50 mg|Non-cirrhotic (NC) participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
74958|NCT02115321|P1|Participant Flow|Part A: CP-B GZR 50 mg + EBR 50 mg|Child-Pugh score 7 to 9 (CP-B) participants take GZR 50 mg + EBR 50 mg once daily (q.d.) by mouth for 12 weeks.
74959|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
74960|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
74961|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
74962|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
74963|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
74964|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
78028|NCT02096900|O1|Outcome|Midazolam|midazolam was given at 0.5mg/kg, pre-operatively single dose
74971|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
74972|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
74973|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
74974|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
74975|NCT02115321|E2|Reported Event|Non-cirrhotic: GZR 100 mg + EBR 50 mg for 12 Weeks|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
74976|NCT02115321|E1|Reported Event|CP-B: GZR 50 mg + EBR 50 mg for 12 Weeks|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
74977|NCT02115269|B1|Baseline|Primary Headaches|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice
74978|NCT02115269|P1|Participant Flow|Primary Headaches|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice
74979|NCT02115269|O6|Outcome|Patients Who Took Opioid Analgesics|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and who took opioid analgesics in the past
74980|NCT02115269|O5|Outcome|Patients Who Took Antiemetics|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and who took antiemetics in the past
74981|NCT02115269|O4|Outcome|Patients Who Took Ergotamine-based Drugs|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and who took ergotamine-based drugs in the past
74982|NCT02115269|O3|Outcome|Patients Who Took Combined Analgesics|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and who took combined analgesics in the past
74983|NCT02115269|O2|Outcome|Patients With Primary Headaches Who Took NSAIDs and Analgesics|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and who took NSAIDs and analgesics
74984|NCT02115269|O1|Outcome|Patients With Primary Headaches and Took Triptans in the Past|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice who took triptans in the past.
74985|NCT02115269|O1|Outcome|Primary Headaches|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice
74986|NCT02115269|O1|Outcome|Primary Headaches|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice
74987|NCT02115269|O5|Outcome|Significant Pain Reduction at 24 Hours Post Dose|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 24 hours post dose
74988|NCT02115269|O4|Outcome|Significant Pain Reduction at 6 Hours Post Dose|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 6 hours post dose
74989|NCT02115269|O3|Outcome|Significant Pain Reduction at 4 Hour Post Dose|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 4 hours post dose
74990|NCT02115269|O2|Outcome|Significant Pain Reduction at 2 Hours Post Dose|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 2 hours post dose
74991|NCT02115269|O1|Outcome|Significant Pain Reduction at 1 Hour Post Dose|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 1 hour post dose
74992|NCT02115269|O1|Outcome|Primary Headaches|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice
74993|NCT02115269|O1|Outcome|Primary Headaches|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice
74994|NCT02115269|E1|Reported Event|Primary Headaches|Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice
74995|NCT02115256|B3|Baseline|Total|Total of all reporting groups
74996|NCT02115256|B2|Baseline|Intravenous Nitroglycerine|"IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.~Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it’s short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms."
74997|NCT02115256|B1|Baseline|Intravenous Terbutaline|"0.25 mL of Intravenous Terbutaline~Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline."
74998|NCT02115256|P2|Participant Flow|Intravenous Nitroglycerine|"IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.~Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it’s short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms."
74999|NCT02115256|P1|Participant Flow|Intravenous Terbutaline|"0.25 mL of Intravenous Terbutaline~Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline."
75000|NCT02115256|O2|Outcome|Intravenous Nitroglycerine|"IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.~Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it’s short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms."
75001|NCT02115256|O1|Outcome|Intravenous Terbutaline|"0.25 mL of Intravenous Terbutaline~Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline."
75002|NCT02115256|O2|Outcome|Intravenous Nitroglycerine|"IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.~Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it’s short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms."
75003|NCT02115256|O1|Outcome|Intravenous Terbutaline|"0.25 mL of Intravenous Terbutaline~Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline."
75004|NCT02115256|O2|Outcome|Intravenous Nitroglycerine|"IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.~Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it’s short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms."
75005|NCT02115256|O1|Outcome|Intravenous Terbutaline|"0.25 mL of Intravenous Terbutaline~Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline."
75006|NCT02115256|O2|Outcome|Intravenous Nitroglycerine|"IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.~Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it’s short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms."
75007|NCT02115256|O1|Outcome|Intravenous Terbutaline|"0.25 mL of Intravenous Terbutaline~Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline."
75008|NCT02115256|E2|Reported Event|Intravenous Nitroglycerine|"IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.~Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it’s short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms."
75009|NCT02115256|E1|Reported Event|Intravenous Terbutaline|"0.25 mL of Intravenous Terbutaline~Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline."
75010|NCT02114931|B3|Baseline|Total|Total of all reporting groups
75011|NCT02114931|B2|Baseline|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
75012|NCT02114931|B1|Baseline|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
75013|NCT02114931|P2|Participant Flow|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
75014|NCT02114931|P1|Participant Flow|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
75015|NCT02114931|O2|Outcome|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
75016|NCT02114931|O1|Outcome|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
75017|NCT02114931|O2|Outcome|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
75018|NCT02114931|O1|Outcome|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
75019|NCT02114931|O2|Outcome|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
75020|NCT02114931|O1|Outcome|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
75021|NCT02114931|O2|Outcome|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
75022|NCT02114931|O1|Outcome|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
75023|NCT02114931|O2|Outcome|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
75024|NCT02114931|O1|Outcome|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
75025|NCT02114931|E2|Reported Event|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
75026|NCT02114931|E1|Reported Event|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
75027|NCT02114892|B3|Baseline|Total|Total of all reporting groups
75028|NCT02114892|B2|Baseline|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
75029|NCT02114892|B1|Baseline|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
75030|NCT02114892|P2|Participant Flow|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
75031|NCT02114892|P1|Participant Flow|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
75032|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
75033|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
75034|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
75035|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
75036|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
75037|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
75038|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
75039|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
75040|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
75041|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
75042|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
75043|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
75044|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
75045|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
75046|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
75047|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
75048|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
75049|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
75050|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
75051|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
75052|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
75053|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
75054|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
75055|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
75056|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
75057|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
75058|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
75059|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
75060|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
75061|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
75062|NCT02114892|E2|Reported Event|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
75063|NCT02114892|E1|Reported Event|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
75064|NCT02114268|B7|Baseline|Total|Total of all reporting groups
75065|NCT02114268|B6|Baseline|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
75066|NCT02114268|B5|Baseline|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
75067|NCT02114268|B4|Baseline|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
75068|NCT02114268|B3|Baseline|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
75069|NCT02114268|B2|Baseline|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
75070|NCT02114268|B1|Baseline|Placebo|Participants received placebo on Day 1.
75071|NCT02114268|P6|Participant Flow|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
75072|NCT02114268|P5|Participant Flow|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
75073|NCT02114268|P4|Participant Flow|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
75074|NCT02114268|P3|Participant Flow|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
75075|NCT02114268|P2|Participant Flow|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
75076|NCT02114268|P1|Participant Flow|Placebo|Participants received placebo on Day 1.
75077|NCT02114268|O6|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
75078|NCT02114268|O5|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
75079|NCT02114268|O4|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
75080|NCT02114268|O3|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
75081|NCT02114268|O2|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
75082|NCT02114268|O1|Outcome|Placebo|Participants received placebo on Day 1.
75083|NCT02114268|O5|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
75084|NCT02114268|O4|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
75085|NCT02114268|O3|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
75086|NCT02114268|O2|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
75087|NCT02114268|O1|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
75088|NCT02114268|O5|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
75089|NCT02114268|O4|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
75090|NCT02114268|O3|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
75091|NCT02114268|O2|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
75092|NCT02114268|O1|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
75093|NCT02114268|O5|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
75094|NCT02114268|O4|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
75095|NCT02114268|O3|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
75096|NCT02114268|O2|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
75097|NCT02114268|O1|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
75098|NCT02114268|O5|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
75099|NCT02114268|O4|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
75100|NCT02114268|O3|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
75101|NCT02114268|O2|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
75102|NCT02114268|O1|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
75103|NCT02114268|O5|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
75104|NCT02114268|O4|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
75105|NCT02114268|O3|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
75106|NCT02114268|O2|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
75107|NCT02114268|O1|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
75108|NCT02114268|O5|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
75109|NCT02114268|O4|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
75110|NCT02114268|O3|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
75111|NCT02114268|O2|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
75112|NCT02114268|O1|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
75113|NCT02114268|O6|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
75114|NCT02114268|O5|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
75115|NCT02114268|O4|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
75116|NCT02114268|O3|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
75117|NCT02114268|O2|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
75118|NCT02114268|O1|Outcome|Placebo|Participants received placebo on Day 1.
75119|NCT02114268|E6|Reported Event|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
75120|NCT02114268|E5|Reported Event|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
75121|NCT02114268|E4|Reported Event|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
75122|NCT02114268|E3|Reported Event|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
75123|NCT02114268|E2|Reported Event|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
75124|NCT02114268|E1|Reported Event|Placebo|Participants received placebo on Day 1.
75125|NCT02114216|B4|Baseline|Total|Total of all reporting groups
75126|NCT02114216|B3|Baseline|NERD Group|subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms
75127|NCT02114216|B2|Baseline|ERD Group|subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms
75128|NCT02114216|B1|Baseline|Control Group|subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms
75129|NCT02114216|P3|Participant Flow|NERD Group|subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms
75130|NCT02114216|P2|Participant Flow|ERD Group|subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms
75131|NCT02114216|P1|Participant Flow|Control Group|subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms
75132|NCT02114216|O3|Outcome|NERD Group|"Subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms. Endoscopic mucosal biopsy was done for every subject.~endoscopic mucosal biopsy: endoscopic mucosal biopsy was undertaken for every participant."
75133|NCT02114216|O2|Outcome|ERD Group|"Subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms. Endoscopic mucosal biopsy was done for every subject.~endoscopic mucosal biopsy: endoscopic mucosal biopsy was undertaken for every participant."
75134|NCT02114216|O1|Outcome|Control Group|"Subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms. Endoscopic mucosal biopsy was done for every subject.~endoscopic mucosal biopsy: endoscopic mucosal biopsy was undertaken for every participant."
75135|NCT02114216|O3|Outcome|NERD Group|subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms
75576|NCT02109484|O3|Outcome|Cohort B 60 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving High Dose P2-VP8
75136|NCT02114216|O2|Outcome|ERD Group|subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms
75137|NCT02114216|O1|Outcome|Control Group|subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms
75138|NCT02114216|E3|Reported Event|NERD Group|subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms
75139|NCT02114216|E2|Reported Event|ERD Group|subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms
75140|NCT02114216|E1|Reported Event|Control Group|subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms
75141|NCT02114203|B4|Baseline|Total|Total of all reporting groups
75142|NCT02114203|B3|Baseline|Placebo|Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
75143|NCT02114203|B2|Baseline|PF-04447943 25 mg BID|PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
75144|NCT02114203|B1|Baseline|PF-04447943 5 mg BID|PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
75145|NCT02114203|P3|Participant Flow|Placebo|Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
75146|NCT02114203|P2|Participant Flow|PF-04447943 25 mg BID|PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
75147|NCT02114203|P1|Participant Flow|PF-04447943 5 mg BID|PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
75148|NCT02114203|O2|Outcome|PF-04447943 25 mg BID|PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
75149|NCT02114203|O1|Outcome|PF-04447943 5 mg BID|PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
75150|NCT02114203|O2|Outcome|PF-04447943 25 mg BID|PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
75151|NCT02114203|O1|Outcome|PF-04447943 5 mg BID|PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
75152|NCT02114203|O2|Outcome|PF-04447943 25 mg BID|PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
75153|NCT02114203|O1|Outcome|PF-04447943 5 mg BID|PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
75154|NCT02114203|O3|Outcome|Placebo|Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
75155|NCT02114203|O2|Outcome|PF-04447943 25 mg BID|PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
75156|NCT02114203|O1|Outcome|PF-04447943 5 mg BID|PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
75157|NCT02114203|O3|Outcome|Placebo|Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
75158|NCT02114203|O2|Outcome|PF-04447943 25 mg BID|PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
75159|NCT02114203|O1|Outcome|PF-04447943 5 mg BID|PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
75160|NCT02114203|O3|Outcome|Placebo|Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
75161|NCT02114203|O2|Outcome|PF-04447943 25 mg BID|PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
75162|NCT02114203|O1|Outcome|PF-04447943 5 mg BID|PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
75163|NCT02114203|O3|Outcome|Placebo|Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
75164|NCT02114203|O2|Outcome|PF-04447943 25 mg BID|PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
75165|NCT02114203|O1|Outcome|PF-04447943 5 mg BID|PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
75166|NCT02114203|O3|Outcome|Placebo|Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
75167|NCT02114203|O2|Outcome|PF-04447943 25 mg BID|PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
75168|NCT02114203|O1|Outcome|PF-04447943 5 mg BID|PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
75169|NCT02114203|O3|Outcome|Placebo|Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
75170|NCT02114203|O2|Outcome|PF-04447943 25 mg BID|PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
75171|NCT02114203|O1|Outcome|PF-04447943 5 mg BID|PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
75172|NCT02114203|O3|Outcome|Placebo|Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
75173|NCT02114203|O2|Outcome|PF-04447943 25 mg BID|PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
75174|NCT02114203|O1|Outcome|PF-04447943 5 mg BID|PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
75175|NCT02114203|E3|Reported Event|Placebo|Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
75176|NCT02114203|E2|Reported Event|PF-04447943 25 mg BID|PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
75177|NCT02114203|E1|Reported Event|PF-04447943 5 mg BID|PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
75178|NCT02114177|B3|Baseline|Total|Total of all reporting groups
75179|NCT02114177|B2|Baseline|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
75180|NCT02114177|B1|Baseline|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
75181|NCT02114177|P2|Participant Flow|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
78029|NCT02096900|O2|Outcome|Zolpidem|zolpidem was given orally 0.25mg/kg pre-operatively single dose
75182|NCT02114177|P1|Participant Flow|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
75183|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
75184|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
75185|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
75186|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
75187|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
75188|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
75189|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
75190|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
75191|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
75192|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
75193|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
75194|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
75195|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
75196|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
75197|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
75198|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
75199|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
75200|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
75201|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
75202|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
75203|NCT02114177|E2|Reported Event|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
75204|NCT02114177|E1|Reported Event|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
75205|NCT02114151|B1|Baseline|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
75206|NCT02114151|P1|Participant Flow|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
75207|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
75208|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
75209|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
75210|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
75211|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
75212|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
75213|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
75214|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
75215|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
75216|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
75577|NCT02109484|O2|Outcome|Cohort B 30 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving Medium Dose P2-VP8
75217|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
75218|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
75219|NCT02114151|E1|Reported Event|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
75220|NCT02113579|B3|Baseline|Total|Total of all reporting groups
75221|NCT02113579|B2|Baseline|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
75222|NCT02113579|B1|Baseline|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
75223|NCT02113579|P2|Participant Flow|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
75224|NCT02113579|P1|Participant Flow|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
75225|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
75226|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
75227|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
75228|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
75229|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
75230|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
75231|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
75232|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
75233|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
75234|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
75235|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
75236|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
75237|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
75238|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
75239|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
75240|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
75241|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
75242|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
75243|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
75244|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
75245|NCT02113579|E2|Reported Event|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
75246|NCT02113579|E1|Reported Event|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
75247|NCT02113449|B1|Baseline|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
75248|NCT02113449|P1|Participant Flow|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
75249|NCT02113449|O1|Outcome|CO2 Nasal Spray|Score from 1 to 7 indicates how much or how little you think the statement applies to this product. A score of 1 indicates that the statement does not apply at all to the product that you used. A score of 7 indicates that it applies completely to it
75250|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
75251|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
75252|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
75253|NCT02113449|O1|Outcome|CO2 Nasal Spray|
75254|NCT02113449|O1|Outcome|C02 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
75255|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
75256|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
75257|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
75258|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
75259|NCT02113449|O1|Outcome|All Participants|"The participants were asked in the beginning which medication they purchase to relieve nasal congestion. Participant could select only one option available. If the participant answered I do not purchase any product to relieve congestion the participant was excluded. Participants could select only one option available."
75260|NCT02113449|E1|Reported Event|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
75261|NCT02113436|B3|Baseline|Total|Total of all reporting groups
75262|NCT02113436|B2|Baseline|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
75263|NCT02113436|B1|Baseline|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
75264|NCT02113436|P4|Participant Flow|FP/SLM 50/25 µg - FP/SLM 50/25 µg|1 or 2 inhalations of FP/SLM HFA MDI 50/25 μg were administered twice daily in TP2 to those participants who received FP/SLM HFA MDI 50/25 μg in TP1.
75265|NCT02113436|P3|Participant Flow|FP HFA 50 µg - FP/SLM HFA 50/25 µg|1 or 2 inhalations of FP/SLM HFA MDI 50/25 μg were administered twice daily in TP2 to those participants who received FP HFA MDI 50 μg in TP1.
75266|NCT02113436|P2|Participant Flow|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
75267|NCT02113436|P1|Participant Flow|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
75268|NCT02113436|O2|Outcome|FP/SLM 50/25 µg - FP/SLM 50/25 µg|1 or 2 inhalations of FP/SLM HFA MDI 50/25 μg were administered twice daily in TP2 to those participants who received FP/SLM HFA MDI 50/25 μg in TP1
75269|NCT02113436|O1|Outcome|FP 50 µg - FP/SLM 50/25 µg|1 or 2 inhalations of FP/SLM HFA MDI 50/25 μg were administered twice daily in TP2 to those participants who received FP HFA MDI 50 μg in TP1.
75270|NCT02113436|O2|Outcome|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
75271|NCT02113436|O1|Outcome|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
75272|NCT02113436|O2|Outcome|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
75273|NCT02113436|O1|Outcome|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
75274|NCT02113436|O2|Outcome|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
75275|NCT02113436|O1|Outcome|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
75276|NCT02113436|O2|Outcome|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
75277|NCT02113436|O1|Outcome|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
75278|NCT02113436|O2|Outcome|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
75279|NCT02113436|O1|Outcome|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
75280|NCT02113436|O2|Outcome|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
75281|NCT02113436|O1|Outcome|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
75282|NCT02113436|O2|Outcome|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
75283|NCT02113436|O1|Outcome|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
75284|NCT02113436|E3|Reported Event|Period 2 - FP/SLM HFA 50/25 μg|1 or 2 inhalations of FP/SLM HFA MDI 50/25 μg were administered twice daily in TP2 to those participants who received FP HFA MDI 50 μg or FP/SLM HFA MDI 50/25 µg in TP1.
75285|NCT02113436|E2|Reported Event|Period 1 - FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
75286|NCT02113436|E1|Reported Event|Period 1 - FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
75287|NCT02113124|B3|Baseline|Total|Total of all reporting groups
75288|NCT02113124|B2|Baseline|Uninjured Control|This group of individuals have no history of brain injury. Ages range between 35 and 70.
75289|NCT02113124|B1|Baseline|Chronic Brain Injury|Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70.
75290|NCT02113124|P2|Participant Flow|Uninjured Control|This group of individuals have no history of brain injury. Ages range between 35 and 70.
75578|NCT02109484|O1|Outcome|Cohort B Placebo|Healthy Infants aged 6 to <8 weeks receiving placebo
75291|NCT02113124|P1|Participant Flow|Chronic Brain Injury|Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70.
75292|NCT02113124|O2|Outcome|Uninjured Control|This group of individuals have no history of brain injury. Ages range between 35 and 70.
75293|NCT02113124|O1|Outcome|Chronic Brain Injury|Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70.
75294|NCT02113124|E2|Reported Event|Uninjured Control|This group of individuals have no history of brain injury. Ages range between 35 and 70.
75295|NCT02113124|E1|Reported Event|Chronic Brain Injury|Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70.
75296|NCT02113007|B1|Baseline|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5~Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
75297|NCT02113007|P1|Participant Flow|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5~Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
75298|NCT02113007|O1|Outcome|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5~Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
75299|NCT02113007|O1|Outcome|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5~Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
75300|NCT02113007|O1|Outcome|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5~Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
75301|NCT02113007|E1|Reported Event|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5~Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
75302|NCT02112448|B3|Baseline|Total|Total of all reporting groups
75303|NCT02112448|B2|Baseline|As Needed Dosing|"Patients in this arm will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~as needed dosing: This group will receive morphine and midazolam as needed to control their pain. Acetaminophen and ketorolac will also be given for pain control in the same manner as the continuous infusion group.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
75304|NCT02112448|B1|Baseline|Continuous Infusion|"Patients in this group will received morphine/midazolam drips at 0.3 mg/kg/hour each. They will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~continuous infusion: This arm will receive continuous morphine/midazolam and 'as needed' doses. This group will receive adjunctive medications, acetaminophen and ketorolac.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
75305|NCT02112448|P2|Participant Flow|Continuous Infusion|"Patients in this group will received morphine/midazolam drips at 0.3 mg/kg/hour each. They will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~continuous infusion: This arm will receive continuous morphine/midazolam and 'as needed' doses. This group will receive adjunctive medications, acetaminophen and ketorolac.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
75306|NCT02112448|P1|Participant Flow|As Needed Dosing|"Patients in this arm will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~as needed dosing: This group will receive morphine and midazolam as needed to control their pain. Acetaminophen and ketorolac will also be given for pain control in the same manner as the continuous infusion group.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
75307|NCT02112448|O2|Outcome|Continuous Infusion|"Patients in this group will received morphine/midazolam drips at 0.3 mg/kg/hour each. They will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~continuous infusion: This arm will receive continuous morphine/midazolam and 'as needed' doses. This group will receive adjunctive medications, acetaminophen and ketorolac.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
75308|NCT02112448|O1|Outcome|As Needed Dosing|"Patients in this arm will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~as needed dosing: This group will receive morphine and midazolam as needed to control their pain. Acetaminophen and ketorolac will also be given for pain control in the same manner as the continuous infusion group.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
75309|NCT02112448|O2|Outcome|As Needed Dosing|"Patients in this arm will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~as needed dosing: This group will receive morphine and midazolam as needed to control their pain. Acetaminophen and ketorolac will also be given for pain control in the same manner as the continuous infusion group.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
75310|NCT02112448|O1|Outcome|Continuous Infusion|"Patients in this group will received morphine/midazolam drips at 0.3 mg/kg/hour each. They will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~continuous infusion: This arm will receive continuous morphine/midazolam and 'as needed' doses. This group will receive adjunctive medications, acetaminophen and ketorolac.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
75311|NCT02112448|E2|Reported Event|Continuous Infusion|"Patients in this group will received morphine/midazolam drips at 0.3 mg/kg/hour each. They will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~continuous infusion: This arm will receive continuous morphine/midazolam and 'as needed' doses. This group will receive adjunctive medications, acetaminophen and ketorolac.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
75312|NCT02112448|E1|Reported Event|As Needed Dosing|"Patients in this arm will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~as needed dosing: This group will receive morphine and midazolam as needed to control their pain. Acetaminophen and ketorolac will also be given for pain control in the same manner as the continuous infusion group.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
75313|NCT02112370|B3|Baseline|Total|Total of all reporting groups
75314|NCT02112370|B2|Baseline|Ropivacaine With Epinephrine Injection|"1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.~Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection."
75315|NCT02112370|B1|Baseline|Normal Saline Injection|"100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.~Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection."
75316|NCT02112370|P2|Participant Flow|Ropivacaine With Epinephrine Injection|"1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.~Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection."
75317|NCT02112370|P1|Participant Flow|Normal Saline Injection|"100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.~Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection."
75318|NCT02112370|O2|Outcome|Ropivacaine With Epinephrine Injection|"1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.~Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection."
75319|NCT02112370|O1|Outcome|Normal Saline Injection|"100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.~Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection."
75320|NCT02112370|O2|Outcome|Ropivacaine With Epinephrine Injection|"1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.~Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection."
75321|NCT02112370|O1|Outcome|Normal Saline Injection|"100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.~Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection."
75322|NCT02112370|O2|Outcome|Ropivacaine With Epinephrine Injection|"1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.~Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection."
75370|NCT02111252|B1|Baseline|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
75323|NCT02112370|O1|Outcome|Normal Saline Injection|"100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.~Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection."
75324|NCT02112370|O2|Outcome|Ropivacaine With Epinephrine Injection|"1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.~Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection."
75325|NCT02112370|O1|Outcome|Normal Saline Injection|"100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.~Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection."
75326|NCT02112370|O2|Outcome|Ropivacaine With Epinephrine Injection|"1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.~Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection."
75327|NCT02112370|O1|Outcome|Normal Saline Injection|"100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.~Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection."
75328|NCT02112370|O2|Outcome|Ropivacaine With Epinephrine Injection|"1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.~Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection."
75329|NCT02112370|O1|Outcome|Normal Saline Injection|"100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.~Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection."
75330|NCT02112370|O2|Outcome|Ropivacaine With Epinephrine Injection|"1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.~Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection."
75331|NCT02112370|O1|Outcome|Normal Saline Injection|"100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.~Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection."
75332|NCT02112370|O2|Outcome|Ropivacaine With Epinephrine Injection|"1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.~Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection."
75333|NCT02112370|O1|Outcome|Normal Saline Injection|"100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.~Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection."
75334|NCT02112370|E2|Reported Event|Ropivacaine With Epinephrine Injection|"1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.~Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection."
75335|NCT02112370|E1|Reported Event|Normal Saline Injection|"100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.~Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection."
75336|NCT02111863|B1|Baseline|Lymphocyte Depleting Prep Regimen|"Patients will receive a lymphocyte depleting preparative regimen of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of 4-1BB selected tumor infiltrating lymphocytes (TIL) plus IV aldesleukin.~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Fludarabine: Fludarabine 25 mg/m^2/day (intravenous piggyback) IVPB daily X 5 days.(The fludarabine will be started approximately 1-2 hours after the cyclophosphamide on Days -5 and -4)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml 5% dextrose in water (D5W) over 1 hr.~4-1BB Selected Tumor Infiltrating Lymphocytes (TIL): On day 0, cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (one to four days after the last dose of fludarabine)."
75337|NCT02111863|P1|Participant Flow|Lymphocyte Depleting Prep Regimen|"Patients will receive a lymphocyte depleting preparative regimen of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of 4-1BB selected tumor infiltrating lymphocytes (TIL) plus IV aldesleukin.~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Fludarabine: Fludarabine 25 mg/m^2/day (intravenous piggyback) IVPB daily X 5 days.(The fludarabine will be started approximately 1-2 hours after the cyclophosphamide on Days -5 and -4)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml 5% dextrose in water (D5W) over 1 hr.~4-1BB Selected Tumor Infiltrating Lymphocytes (TIL): On day 0, cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (one to four days after the last dose of fludarabine)."
75371|NCT02111252|P1|Participant Flow|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
75372|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
78030|NCT02096900|O1|Outcome|Midazolam|midazolam was given at 0.5mg/kg, pre-operatively single dose
75338|NCT02111863|O1|Outcome|Lymphocyte Depleting Prep Regimen|"Patients will receive a lymphocyte depleting preparative regimen of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of 4-1BB selected tumor infiltrating lymphocytes (TIL) plus IV aldesleukin.~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Fludarabine: Fludarabine 25 mg/m^2/day (intravenous piggyback) IVPB daily X 5 days.(The fludarabine will be started approximately 1-2 hours after the cyclophosphamide on Days -5 and -4)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml 5% dextrose in water (D5W) over 1 hr.~4-1BB Selected Tumor Infiltrating Lymphocytes (TIL): On day 0, cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (one to four days after the last dose of fludarabine)."
75339|NCT02111863|O1|Outcome|Lymphocyte Depleting Prep Regimen|"Patients will receive a lymphocyte depleting preparative regimen of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of 4-1BB selected tumor infiltrating lymphocytes (TIL) plus IV aldesleukin.~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Fludarabine: Fludarabine 25 mg/m^2/day (intravenous piggyback) IVPB daily X 5 days.(The fludarabine will be started approximately 1-2 hours after the cyclophosphamide on Days -5 and -4)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml 5% dextrose in water (D5W) over 1 hr.~4-1BB Selected Tumor Infiltrating Lymphocytes (TIL): On day 0, cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (one to four days after the last dose of fludarabine)."
75340|NCT02111863|O1|Outcome|Lymphocyte Depleting Prep Regimen|"Patients will receive a lymphocyte depleting preparative regimen of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of 4-1BB selected tumor infiltrating lymphocytes (TIL) plus IV aldesleukin.~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Fludarabine: Fludarabine 25 mg/m^2/day (intravenous piggyback) IVPB daily X 5 days.(The fludarabine will be started approximately 1-2 hours after the cyclophosphamide on Days -5 and -4)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml 5% dextrose in water (D5W) over 1 hr.~4-1BB Selected Tumor Infiltrating Lymphocytes (TIL): On day 0, cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (one to four days after the last dose of fludarabine)."
75341|NCT02111863|E1|Reported Event|Lymphocyte Depleting Prep Regimen|"Patients will receive a lymphocyte depleting preparative regimen of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of 4-1BB selected tumor infiltrating lymphocytes (TIL) plus IV aldesleukin.~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Fludarabine: Fludarabine 25 mg/m^2/day (intravenous piggyback) IVPB daily X 5 days.(The fludarabine will be started approximately 1-2 hours after the cyclophosphamide on Days -5 and -4)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml 5% dextrose in water (D5W) over 1 hr.~4-1BB Selected Tumor Infiltrating Lymphocytes (TIL): On day 0, cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (one to four days after the last dose of fludarabine)."
75342|NCT02111772|B3|Baseline|Total|Total of all reporting groups
75343|NCT02111772|B2|Baseline|Without Asthma|"Subjects without asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus~Rhinovirus"
75344|NCT02111772|B1|Baseline|Asthmatic Subjects|"Subjects with Asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus.~Rhinovirus"
75345|NCT02111772|P2|Participant Flow|Without Asthma|"Subjects without asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus~Rhinovirus"
75346|NCT02111772|P1|Participant Flow|Asthmatic Subjects|"Subjects with Asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus.~Rhinovirus"
75347|NCT02111772|O2|Outcome|Without Asthma|"Subjects without asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus~Rhinovirus"
75348|NCT02111772|O1|Outcome|Asthmatic Subjects|"Subjects with Asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus.~Rhinovirus"
75349|NCT02111772|O2|Outcome|Without Asthma|"Subjects without asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus~Rhinovirus"
75350|NCT02111772|O1|Outcome|Asthmatic Subjects|"Subjects with Asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus.~Rhinovirus"
75351|NCT02111772|E2|Reported Event|Without Asthma|"Subjects without asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus~Rhinovirus"
75352|NCT02111772|E1|Reported Event|Asthmatic Subjects|"Subjects with Asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus.~Rhinovirus"
75353|NCT02111603|B1|Baseline|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
75354|NCT02111603|P1|Participant Flow|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
75355|NCT02111603|O1|Outcome|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
75356|NCT02111603|O1|Outcome|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
75357|NCT02111603|O1|Outcome|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
75358|NCT02111603|O1|Outcome|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
75359|NCT02111603|O1|Outcome|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
75360|NCT02111603|O1|Outcome|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
75361|NCT02111603|E1|Reported Event|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
75373|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
75374|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
75362|NCT02111369|B1|Baseline|Propranolol/Botulinum|After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.
75363|NCT02111369|P1|Participant Flow|Propranolol/Botulinum|"After baseline analysis, patient will be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the patient had demonstrated no side effects. Dose may be increased to 240 mg each day depending on patient improvement and side effect profile. After second evaluation, patient will receive botulinum toxin injections. The risks and benefits of botulinum toxin therapy will be explained to the patient, and bilateral injections will take place.~Propranolol: After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days"
75364|NCT02111369|O1|Outcome|Propranolol/Botulinum|"After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.~Propranolol: After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days"
75365|NCT02111369|O1|Outcome|Propranolol/Botulinum|"After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.~Propranolol: After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days"
75366|NCT02111369|O1|Outcome|Propranolol/Botulinum|"After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.~Propranolol: After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days"
75367|NCT02111369|O1|Outcome|Propranolol/Botulinum|"After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.~Propranolol: After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days"
75368|NCT02111369|O1|Outcome|Propranolol/Botulinum|"After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.~Propranolol: After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days"
75369|NCT02111369|E1|Reported Event|Propranolol/Botulinum|After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.
78031|NCT02096900|O2|Outcome|Zolpidem|zolpidem was given orally 0.25mg/kg pre-operatively single dose
75375|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
75376|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
75377|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
75378|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
75379|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
75380|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
75381|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
75382|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
75383|NCT02111252|E1|Reported Event|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
75384|NCT02111200|B5|Baseline|Total|Total of all reporting groups
75385|NCT02111200|B4|Baseline|MIX-> Sodium Phenylbutyrate-> Sodium Benzoate|"MIX arm: Participants received a combination of Sodium Phenylbutyrate 3.575 g/m2/day and Sodium Benzoate 2.75 g/m2/day were given in three equal doses per day for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~Sodium phenylbutyrate arm: Participants received ONLY sodium phenylbutyrate at a dose of 7.15 g/m2/day divided into three equal doses per day (maximum dose of 20 g/day) for 3 days. Subjects took the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~Sodium benzoate: Participants received ONLY Sodium Benzoate at a dose of 5.5 g/m2/day divided into three equal doses per day (maximum dose 12 g/day) for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
75386|NCT02111200|B3|Baseline|MIX->Sodium Benzoate-> Sodium Phenylbutyrate|"MIX arm: Participants received a combination of Sodium Phenylbutyrate 3.575 g/m2/day and Sodium Benzoate 2.75 g/m2/day were given in three equal doses per day for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~Sodium benzoate: Participants received ONLY Sodium Benzoate at a dose of 5.5 g/m2/day divided into three equal doses per day (maximum dose 12 g/day) for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~Sodium phenylbutyrate arm: Participants received ONLY sodium phenylbutyrate at a dose of 7.15 g/m2/day divided into three equal doses per day (maximum dose of 20 g/day) for 3 days. Subjects took the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
75387|NCT02111200|B2|Baseline|Sodium Benzoate->MIX-> Sodium Phenylbutyrate|"Sodium benzoate: Participants received ONLY Sodium Benzoate at a dose of 5.5 g/m2/day divided into three equal doses per day (maximum dose 12 g/day) for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~MIX arm: Participants received a combination of Sodium Phenylbutyrate 3.575 g/m2/day and Sodium Benzoate 2.75 g/m2/day were given in three equal doses per day for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~Sodium phenylbutyrate arm: Participants received ONLY sodium phenylbutyrate at a dose of 7.15 g/m2/day divided into three equal doses per day (maximum dose of 20 g/day) for 3 days. Subjects took the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
75388|NCT02111200|B1|Baseline|Sodium Phenylbutyrate->MIX->Sodium Benzoate|"Sodium phenylbutyrate arm: Participants received ONLY sodium phenylbutyrate at a dose of 7.15 g/m2/day divided into three equal doses per day (maximum dose of 20 g/day) for 3 days. Subjects took the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~MIX arm: Participants received a combination of Sodium Phenylbutyrate 3.575 g/m2/day and Sodium Benzoate 2.75 g/m2/day were given in three equal doses per day for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~Sodium benzoate: Participants received ONLY Sodium Benzoate at a dose of 5.5 g/m2/day divided into three equal doses per day (maximum dose 12 g/day) for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
75389|NCT02111200|P4|Participant Flow|MIX-> Sodium Phenylbutyrate-> Sodium Benzoate (4 Days)|"MIX arm: Participants received a combination of Sodium Phenylbutyrate 3.575 g/m2/day and Sodium Benzoate 2.75 g/m2/day were given in three equal doses per day for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~Sodium phenylbutyrate arm: Participants received ONLY sodium phenylbutyrate at a dose of 7.15 g/m2/day divided into three equal doses per day (maximum dose of 20 g/day) for 3 days. Subjects took the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~Sodium benzoate: Participants received ONLY Sodium Benzoate at a dose of 5.5 g/m2/day divided into three equal doses per day (maximum dose 12 g/day) for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
75390|NCT02111200|P3|Participant Flow|MIX->Sodium Benzoate-> Sodium Phenylbutyrate (4 Days)|"MIX arm: Participants received a combination of Sodium Phenylbutyrate 3.575 g/m2/day and Sodium Benzoate 2.75 g/m2/day were given in three equal doses per day for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~Sodium benzoate: Participants received ONLY Sodium Benzoate at a dose of 5.5 g/m2/day divided into three equal doses per day (maximum dose 12 g/day) for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~Sodium phenylbutyrate arm: Participants received ONLY sodium phenylbutyrate at a dose of 7.15 g/m2/day divided into three equal doses per day (maximum dose of 20 g/day) for 3 days. Subjects took the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
75391|NCT02111200|P2|Participant Flow|Sodium Benzoate->MIX-> Sodium Phenylbutyrate (4 Days)|"Sodium benzoate: Participants received ONLY Sodium Benzoate at a dose of 5.5 g/m2/day divided into three equal doses per day (maximum dose 12 g/day) for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~MIX arm: Participants received a combination of Sodium Phenylbutyrate 3.575 g/m2/day and Sodium Benzoate 2.75 g/m2/day were given in three equal doses per day for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~Sodium phenylbutyrate arm: Participants received ONLY sodium phenylbutyrate at a dose of 7.15 g/m2/day divided into three equal doses per day (maximum dose of 20 g/day) for 3 days. Subjects took the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
75392|NCT02111200|P1|Participant Flow|Sodium Phenylbutyrate->MIX->Sodium Benzoate (4 Days)|"Sodium phenylbutyrate arm: Participants received ONLY sodium phenylbutyrate at a dose of 7.15 g/m2/day divided into three equal doses per day (maximum dose of 20 g/day) for 3 days. Subjects took the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~MIX arm: Participants received a combination of Sodium Phenylbutyrate 3.575 g/m2/day and Sodium Benzoate 2.75 g/m2/day were given in three equal doses per day for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Followed by a Washout period of at least 7 days~Sodium benzoate: Participants received ONLY Sodium Benzoate at a dose of 5.5 g/m2/day divided into three equal doses per day (maximum dose 12 g/day) for 3 days. Subjects took the study medications with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
75393|NCT02111200|O3|Outcome|Mix Arm|"Sodium Phenylbutyrate 3.575 g/m2/day and Sodium Benzoate 2.75 g/m2/day will be given in three equal doses per day for 3 days~Sodium Benzoate: Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Sodium Phenylbutyrate: Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
75394|NCT02111200|O2|Outcome|Sodium Phenylbutyrate Arm|"Sodium phenylbutyrate 7.15 g/m2/day divided into three equal doses per day (maximum dose of 20 g/day) for 3 days~Sodium Phenylbutyrate: Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
75395|NCT02111200|O1|Outcome|Sodium Benzoate Arm|"Sodium benzoate 5.5 g/m2/day divided into three equal doses per day (maximum dose 12 g/day) for 3 days~Sodium Benzoate: Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
75396|NCT02111200|O3|Outcome|Mix Arm|"Sodium Phenylbutyrate 3.575 g/m2/day and Sodium Benzoate 2.75 g/m2/day will be given in three equal doses per day for 3 days~Sodium Benzoate: Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Sodium Phenylbutyrate: Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
75397|NCT02111200|O2|Outcome|Sodium Phenylbutyrate Arm|"Sodium phenylbutyrate 7.15 g/m2/day divided into three equal doses per day (maximum dose of 20 g/day) for 3 days~Sodium Phenylbutyrate: Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
75398|NCT02111200|O1|Outcome|Sodium Benzoate Arm|"Sodium benzoate 5.5 g/m2/day divided into three equal doses per day (maximum dose 12 g/day) for 3 days~Sodium Benzoate: Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
75399|NCT02111200|O3|Outcome|Mix Arm|"Sodium Phenylbutyrate 3.575 g/m2/day and Sodium Benzoate 2.75 g/m2/day will be given in three equal doses per day for 3 days~Sodium Benzoate: Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Sodium Phenylbutyrate: Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
75400|NCT02111200|O2|Outcome|Sodium Phenylbutyrate Arm|"Sodium phenylbutyrate 7.15 g/m2/day divided into three equal doses per day (maximum dose of 20 g/day) for 3 days~Sodium Phenylbutyrate: Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
75401|NCT02111200|O1|Outcome|Sodium Benzoate Arm|"Sodium benzoate 5.5 g/m2/day divided into three equal doses per day (maximum dose 12 g/day) for 3 days~Sodium Benzoate: Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
75402|NCT02111200|E3|Reported Event|MIX Treatment|"Sodium Phenylbutyrate 3.575 g/m2/day and Sodium Benzoate 2.75 g/m2/day will be given in three equal doses per day for 3 days~Sodium Benzoate: Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.~Sodium Phenylbutyrate: Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
75403|NCT02111200|E2|Reported Event|Sodium Phenylbutyrate Treatment|"Sodium phenylbutyrate 7.15 g/m2/day divided into three equal doses per day (maximum dose of 20 g/day) for 3 days~Sodium Phenylbutyrate: Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
75404|NCT02111200|E1|Reported Event|Sodium Benzoate Treatment|"Sodium benzoate 5.5 g/m2/day divided into three equal doses per day (maximum dose 12 g/day) for 3 days~Sodium Benzoate: Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days."
75405|NCT02111096|B4|Baseline|Total|Total of all reporting groups
75406|NCT02111096|B3|Baseline|Placebo|Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75407|NCT02111096|B2|Baseline|Sitagliptin|100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75408|NCT02111096|B1|Baseline|LY2409021|20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75409|NCT02111096|P3|Participant Flow|Placebo|Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75579|NCT02109484|O4|Outcome|Cohort B 60 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving High Dose P2-VP8
75410|NCT02111096|P2|Participant Flow|Sitagliptin|100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75411|NCT02111096|P1|Participant Flow|LY2409021|20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75412|NCT02111096|O3|Outcome|Placebo|Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75413|NCT02111096|O2|Outcome|Sitagliptin|100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75414|NCT02111096|O1|Outcome|LY2409021|20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75415|NCT02111096|O3|Outcome|Placebo|Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75416|NCT02111096|O2|Outcome|Sitagliptin|100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75417|NCT02111096|O1|Outcome|LY2409021|20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75418|NCT02111096|O1|Outcome|LY2409021|20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75419|NCT02111096|O1|Outcome|LY2409021|20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75420|NCT02111096|O3|Outcome|Placebo|Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75421|NCT02111096|O2|Outcome|Sitagliptin|100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75422|NCT02111096|O1|Outcome|LY2409021|20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75423|NCT02111096|O3|Outcome|Placebo|Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75424|NCT02111096|O2|Outcome|Sitagliptin|100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75425|NCT02111096|O1|Outcome|LY2409021|20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75426|NCT02111096|O3|Outcome|Placebo|Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75427|NCT02111096|O2|Outcome|Sitagliptin|100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75428|NCT02111096|O1|Outcome|LY2409021|20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75429|NCT02111096|O3|Outcome|Placebo|Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75430|NCT02111096|O2|Outcome|Sitagliptin|100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75431|NCT02111096|O1|Outcome|LY2409021|20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75432|NCT02111096|O3|Outcome|Placebo|Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75433|NCT02111096|O2|Outcome|Sitagliptin|100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75434|NCT02111096|O1|Outcome|LY2409021|20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75435|NCT02111096|O3|Outcome|Placebo|Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75436|NCT02111096|O2|Outcome|Sitagliptin|100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75437|NCT02111096|O1|Outcome|LY2409021|20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75469|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
75438|NCT02111096|O3|Outcome|Placebo|Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75439|NCT02111096|O2|Outcome|Sitagliptin|100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75440|NCT02111096|O1|Outcome|LY2409021|20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75441|NCT02111096|O3|Outcome|Placebo|Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75442|NCT02111096|O2|Outcome|Sitagliptin|100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75443|NCT02111096|O1|Outcome|LY2409021|20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75444|NCT02111096|O3|Outcome|Placebo|Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75445|NCT02111096|O2|Outcome|Sitagliptin|100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75446|NCT02111096|O1|Outcome|LY2409021|20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75447|NCT02111096|O3|Outcome|Placebo|Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75448|NCT02111096|O2|Outcome|Sitagliptin|100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75449|NCT02111096|O1|Outcome|LY2409021|20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75450|NCT02111096|O3|Outcome|Placebo|Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75451|NCT02111096|O2|Outcome|Sitagliptin|100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75452|NCT02111096|O1|Outcome|LY2409021|20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75453|NCT02111096|E3|Reported Event|Placebo|Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75454|NCT02111096|E2|Reported Event|Sitagliptin|100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75455|NCT02111096|E1|Reported Event|LY2409021|20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
75456|NCT02111083|B3|Baseline|Total|Total of all reporting groups
75457|NCT02111083|B2|Baseline|Insulin Lispro Dosing Sequence RTRT|Each subject was administered insulin lispro A U-200 (test [T] on 2 occasions) and insulin lispro B U-100 (reference [R] on 2 occasions). Subjects were randomly assigned to dosing sequences RTRT.
75458|NCT02111083|B1|Baseline|Insulin Lispro Dosing Sequence TRTR|Each subject was administered insulin lispro A U-200 (test [T] on 2 occasions) and insulin lispro B U-100(reference [R] on 2 occasions).Subjects were randomly assigned to dosing sequences TRTR.
75459|NCT02111083|P2|Participant Flow|Insulin Lispro Dosing Sequence RTRT|Each subject was administered insulin lispro A 20 units (U) of strength 200 units per milliliter (U/mL) (U-200) (test [T] on 2 occasions) and insulin lispro B 20 units (U) of strength 100 U/mL (U-100) (reference [R] on 2 occasions).Subjects were randomly assigned to dosing sequences RTRT.
75460|NCT02111083|P1|Participant Flow|Insulin Lispro Dosing Sequence TRTR|Each subject was administered insulin lispro A 20 units (U) of strength 200 units per milliliter (U/mL) (U-200) (test [T] on 2 occasions) and insulin lispro B 20 units (U) of strength 100 U/mL (U-100) (reference [R] on 2 occasions).Subjects were randomly assigned to dosing sequences TRTR.
75461|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
75462|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
75463|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
75464|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
75465|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
75466|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
75467|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
75468|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
78032|NCT02096900|O1|Outcome|Midazolam|midazolam was given at 0.5mg/kg, pre-operatively single dose
75470|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
75471|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
75472|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
75473|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
75474|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
75475|NCT02111083|E2|Reported Event|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
75476|NCT02111083|E1|Reported Event|Insulin Lispro A|Insulin Lispro A U-200 subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
75477|NCT02110693|B1|Baseline|Interviewer and Tablet Administration of TAPS Tool|All participants self-administered TAPS Tool on a computer tablet and were administered the TAPS Tool by an interviewer
75478|NCT02110693|P2|Participant Flow|Tablet First Then Interviewer Administration|Self-administration on tablet computer of screening instrument first, then interviewer administration of the same instrument.
75479|NCT02110693|P1|Participant Flow|Interviewer Then Tablet Administration|Interviewer will administer the substance use screening instrument first then self-administration of the same instrument on a tablet computer
75480|NCT02110693|O2|Outcome|Self-administered TAPS Tool|Self administered TAPS Tool. Oral Fluid Cannabis Test administered to the subset of participants that consented to provide an oral fluid sample. Oral fluid specimen was collected the same way in both arms.
75481|NCT02110693|O1|Outcome|Interviewer Administered|Interviewer administered TAPS Tool. Oral Fluid Cannabis Test administered to the subset of participants that consented to provide an oral fluid sample. Oral fluid specimen was collected the same way in both arms.
75482|NCT02110693|O2|Outcome|Self Administered|Self-administered TAPS Tool. The Smokeless Tobacco Questionnaire was interviewer administered.
75483|NCT02110693|O1|Outcome|Interviewer Administered|Interviewer administered TAPS Tool. The Smokeless Tobacco Questionnaire was interviewer administered.
75484|NCT02110693|O2|Outcome|Interviewer Administered|Interviewer administered TAPS Tool. The Fagerstrom Test was interviewer administered.
75485|NCT02110693|O1|Outcome|Self-administered TAPS Tool|Self-administered TAPS Tool. The Fagerstrom Test for Nicotine Dependence was administered by interviewer.
75486|NCT02110693|O2|Outcome|Interviewer Administered|Interviewer administered TAPS Tool. The AUDIT-C was interviewer administered for both group
75487|NCT02110693|O1|Outcome|Self-administered|Self-administered TAPS Tool. The AUDIT-C was interviewer administered.
75488|NCT02110693|O2|Outcome|Tablet Administration|Tablet computer administration of TAPS Tool. The TLFB was interviewer administered.
75489|NCT02110693|O1|Outcome|Interviewer Administered|Interviewer administered TAPS. The Time Line Follow Back was interviewer administered.
75490|NCT02110693|O2|Outcome|Tablet Administration|Tablet computer administration of TAPS Tool. The ASSIST was administered in by an interview.
75491|NCT02110693|O1|Outcome|Interviewer Administered|Interviewer administration of TAPS Tool. The ASSIST was interviewer administered as well.
75492|NCT02110693|O2|Outcome|Tablet Administration|Tablet computer administration of a substance misuse screening instrument (TAPS Tool).
75493|NCT02110693|O1|Outcome|Interviewer Administration|Interviewer administration of a substance misuse screening instrument (TAPS Tool).
75494|NCT02110693|O2|Outcome|Tablet Administration|Tablet computer of a substance misuse screening instrument (TAPS Tool).
75495|NCT02110693|O1|Outcome|Interviewer Administration|Interviewer administration of a substance misuse screening instrument (TAPS Tool).
75496|NCT02110693|O2|Outcome|Tablet Administration|Tablet computer administration of a substance misuse screening instrument (TAPS Tool).
75497|NCT02110693|O1|Outcome|Interviewer Administration|Interviewer administration of a substance misuse screening instrument (TAPS Tool).
75498|NCT02110693|O2|Outcome|Tablet Administration|Tablet computer administration of a substance misuse screening instrument (TAPS Tool).
75499|NCT02110693|O1|Outcome|Interviewer Administration|Interviewer administration of a substance misuse screening instrument (TAPS Tool)
75500|NCT02110693|O2|Outcome|Tablet Administration|Self-administration on tablet computer of screening instrument for substance misuse (TAPS Tool).
75501|NCT02110693|O1|Outcome|Interviewer Administration|Interviewer administration of a substance misuse screening instrument (TAPS Tool).
75502|NCT02110693|E1|Reported Event|All Participants|All participants enrolled in the study (because all participants were administered both the self-administered and the interviewer administered versions of the instrument, we are reporting adverse events for the total sample)
75503|NCT02110381|B3|Baseline|Total|Total of all reporting groups
75504|NCT02110381|B2|Baseline|Isometric Hand Grip|"Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit."
75534|NCT02110147|O1|Outcome|Uridine Triacetate|All patients were treated with uridine triacetate oral granules.
75535|NCT02110147|O1|Outcome|Uridine Triacetate|All patients were treated with uridine triacetate oral granules.
75536|NCT02110147|E1|Reported Event|Single Arm|All patients were treated with uridine triacetate oral granules.
75580|NCT02109484|O3|Outcome|Cohort B 30 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving Medium Dose P2-VP8
75581|NCT02109484|O2|Outcome|Cohort B 10 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving Low Dose P2-VP8
75505|NCT02110381|B1|Baseline|Device Guided Breathing|"Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit."
75506|NCT02110381|P2|Participant Flow|Isometric Hand Grip|"Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit."
75507|NCT02110381|P1|Participant Flow|Device Guided Breathing|"Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit."
75508|NCT02110381|O2|Outcome|Isometric Hand Grip|"Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit."
75509|NCT02110381|O1|Outcome|Device Guided Breathing|"Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit."
75510|NCT02110381|O2|Outcome|Isometric Hand Grip|"Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit."
75511|NCT02110381|O1|Outcome|Device Guided Breathing|"Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit."
75512|NCT02110381|O2|Outcome|Isometric Hand Grip|"Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit."
75513|NCT02110381|O1|Outcome|Device Guided Breathing|"Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit."
75514|NCT02110381|E3|Reported Event|Screen Failures|These subjects reflect individuals who: 1) consented to be in the study, 2) participated in the initial run-in period to evaluate blood pressure, 3) ended up not meeting the blood pressure criteria required for randomization
75515|NCT02110381|E2|Reported Event|Isometric Hand Grip|"Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit."
75516|NCT02110381|E1|Reported Event|Device Guided Breathing|"Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit."
75517|NCT02110277|B1|Baseline|PAI/Ultrasound Diagnostic Group|"These patients will include women who are at risk for ovarian cancer and wish to undergo prophylactic oophorectomy, or who have an ovarian mass suggestive of a malignancy and are counseled to undergo oophorectomy.~PAI/ultrasound Diagnostic Group: These patients will include women who are at risk for ovarian cancer and wish to undergo prophylactic oophorectomy, or who have an ovarian mass suggestive of a malignancy and are counseled to undergo oophorectomy."
75518|NCT02110277|P1|Participant Flow|PAI/Ultrasound Diagnostic Group|"These patients will include women who are at risk for ovarian cancer and wish to undergo prophylactic oophorectomy, or who have an ovarian mass suggestive of a malignancy and are counseled to undergo oophorectomy.~PAI/ultrasound Diagnostic Group: These patients will include women who are at risk for ovarian cancer and wish to undergo prophylactic oophorectomy, or who have an ovarian mass suggestive of a malignancy and are counseled to undergo oophorectomy."
75519|NCT02110277|O1|Outcome|PAI/Ultrasound Diagnostic Group|"These patients will include women who are at risk for ovarian cancer and wish to undergo prophylactic oophorectomy, or who have an ovarian mass suggestive of a malignancy and are counseled to undergo oophorectomy.~PAI/ultrasound Diagnostic Group: These patients will include women who are at risk for ovarian cancer and wish to undergo prophylactic oophorectomy, or who have an ovarian mass suggestive of a malignancy and are counseled to undergo oophorectomy."
75520|NCT02110277|O1|Outcome|PAI/Ultrasound Diagnostic Group|"These patients will include women who are at risk for ovarian cancer and wish to undergo prophylactic oophorectomy, or who have an ovarian mass suggestive of a malignancy and are counseled to undergo oophorectomy.~PAI/ultrasound Diagnostic Group: These patients will include women who are at risk for ovarian cancer and wish to undergo prophylactic oophorectomy, or who have an ovarian mass suggestive of a malignancy and are counseled to undergo oophorectomy."
75521|NCT02110277|E1|Reported Event|PAI/Ultrasound Diagnostic Group|"These patients will include women who are at risk for ovarian cancer and wish to undergo prophylactic oophorectomy, or who have an ovarian mass suggestive of a malignancy and are counseled to undergo oophorectomy.~PAI/ultrasound Diagnostic Group: These patients will include women who are at risk for ovarian cancer and wish to undergo prophylactic oophorectomy, or who have an ovarian mass suggestive of a malignancy and are counseled to undergo oophorectomy."
75522|NCT02110238|B3|Baseline|Total|Total of all reporting groups
75523|NCT02110238|B2|Baseline|Supartz|SUPARTZ® Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
75524|NCT02110238|B1|Baseline|Euflexxa|Euflexxa® Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
75525|NCT02110238|P2|Participant Flow|Supartz|"SUPARTZ® (hyaluronic acid of avian origin)~Supartz: Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2."
75526|NCT02110238|P1|Participant Flow|Euflexxa|"Euflexxa® (hyaluronic acid of bacterial origin)~Euflexxa: Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2."
75527|NCT02110238|O2|Outcome|Supartz|SUPARTZ® Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
75528|NCT02110238|O1|Outcome|Euflexxa|Euflexxa® Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
75529|NCT02110238|E2|Reported Event|Supartz|SUPARTZ® (hyaluronic acid of avian origin) Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
75530|NCT02110238|E1|Reported Event|Euflexxa|Euflexxa® (hyaluronic acid of bacterial origin) Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
75531|NCT02110147|B1|Baseline|Single Arm|All patients were treated with uridine triacetate oral granules.
75532|NCT02110147|P1|Participant Flow|Single Arm|All patients were treated with uridine triacetate oral granules.
75533|NCT02110147|O1|Outcome|Uridine Triacetate|All patients were treated with uridine triacetate oral granules.
75537|NCT02109731|B1|Baseline|Negative Airway Pressure Delivery|"Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep.~Negative airway pressure delivery: Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep."
75538|NCT02109731|P1|Participant Flow|Negative Airway Pressure Delivery|"Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep.~Negative airway pressure delivery: Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep."
75539|NCT02109731|O1|Outcome|Negative Airway Pressure Delivery|"Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep.~Negative airway pressure delivery: Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep."
75540|NCT02109731|E1|Reported Event|Negative Airway Pressure Delivery|"Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep.~Negative airway pressure delivery: Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep."
75541|NCT02109640|B3|Baseline|Total|Total of all reporting groups
75542|NCT02109640|B2|Baseline|Oxycodone|"Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy~Oxycodone: Postoperative analgesia~Laparoscopic segmental colectomy"
75543|NCT02109640|B1|Baseline|Targinact|"Oral Targinact 10-20mg bd following laparoscopic segmental colectomy~Targinact: Post-operative analgesia~Laparoscopic segmental colectomy"
75544|NCT02109640|P2|Participant Flow|Oxycodone|"Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy~Oxycodone: Postoperative analgesia~Laparoscopic segmental colectomy"
75545|NCT02109640|P1|Participant Flow|Targinact|"Oral Targinact 10-20mg bd following laparoscopic segmental colectomy~Targinact: Post-operative analgesia~Laparoscopic segmental colectomy"
75546|NCT02109640|O2|Outcome|Oxycodone|"Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy~Oxycodone: Postoperative analgesia~Laparoscopic segmental colectomy"
75547|NCT02109640|O1|Outcome|Targinact|"Oral Targinact 10-20mg bd following laparoscopic segmental colectomy~Targinact: Post-operative analgesia~Laparoscopic segmental colectomy"
75548|NCT02109640|O2|Outcome|Oxycodone|"Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy~Oxycodone: Postoperative analgesia~Laparoscopic segmental colectomy"
75549|NCT02109640|O1|Outcome|Targinact|"Oral Targinact 10-20mg bd following laparoscopic segmental colectomy~Targinact: Post-operative analgesia~Laparoscopic segmental colectomy"
75550|NCT02109640|O2|Outcome|Oxycodone|"Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy~Oxycodone: Postoperative analgesia~Laparoscopic segmental colectomy"
75551|NCT02109640|O1|Outcome|Targinact|"Oral Targinact 10-20mg bd following laparoscopic segmental colectomy~Targinact: Post-operative analgesia~Laparoscopic segmental colectomy"
75552|NCT02109640|E2|Reported Event|Oxycodone|"Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy~Oxycodone: Postoperative analgesia~Laparoscopic segmental colectomy"
75553|NCT02109640|E1|Reported Event|Targinact|"Oral Targinact 10-20mg bd following laparoscopic segmental colectomy~Targinact: Post-operative analgesia~Laparoscopic segmental colectomy"
75554|NCT02109497|B1|Baseline|Caffeine Dosing|"Single dose of caffeine 100 mg administered on Day 1 and Day 12~PBT2: PBT2 250 mg administered is Day 8 to 12."
75555|NCT02109497|P1|Participant Flow|Caffeine Dosing|Single dose of caffeine 100 mg administered on Day 1 and Day 12 with PBT2 250 mg administered from Day 8 to 12.
75556|NCT02109497|O1|Outcome|Caffeine Dosing|"Single dose of caffeine 100 mg administered on Day 1 and Day 12~PBT2: PBT2 250 mg administered is Day 8 to 12."
75557|NCT02109497|O1|Outcome|Caffeine Dosing|"Single dose of caffeine 100 mg administered on Day 1 and Day 12~PBT2: PBT2 250 mg administered is Day 8 to 12."
75558|NCT02109497|E1|Reported Event|Caffeine Dosing|"Single dose of caffeine 100 mg administered on Day 1 and Day 12~PBT2: PBT2 250 mg administered is Day 8 to 12."
75559|NCT02109484|B9|Baseline|Total|Total of all reporting groups
75560|NCT02109484|B8|Baseline|Cohort B 60 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving High Dose P2-VP8
75561|NCT02109484|B7|Baseline|Cohort B 30 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving Medium Dose P2-VP8
75562|NCT02109484|B6|Baseline|Cohort B 10 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving Low Dose P2-VP8
75563|NCT02109484|B5|Baseline|Cohort B Placebo|Healthy Infants aged 6 to <8 weeks receiving placeblo
75564|NCT02109484|B4|Baseline|Cohort A 60 mcg P2-VP8|Healthy toddlers aged 2 to < 3 years receiving High Dose P2-VP8
75565|NCT02109484|B3|Baseline|Cohort A 30 mcg P2-VP8|Healthy toddlers aged 2 to < 3 years receiving Medium Dose Ps-VP9
75566|NCT02109484|B2|Baseline|Cohort A 10 mcg P2-VP8|Healthy toddlers aged 2 to < 3 years receiving low dose P2-VP8
75567|NCT02109484|B1|Baseline|Cohort A Placebo|Healthy toddlers aged 2 to < 3 years receiving placebo
75568|NCT02109484|P8|Participant Flow|Cohort B 60 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving high dose of P2-VP8
75569|NCT02109484|P7|Participant Flow|Cohort B 30 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks of age receiving a medium dose of P2-VP8
75570|NCT02109484|P6|Participant Flow|Cohort B 10 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving low dose P2-VP8
75571|NCT02109484|P5|Participant Flow|Cohort B Placebo|Healthy Infants aged 6 to <8 weeks receiving placebo
75572|NCT02109484|P4|Participant Flow|Cohort A 60 mcg P2-VP8|Healthy toddlers aged 2 to < 3 yrs receiving high dose P2-PV8
75573|NCT02109484|P3|Participant Flow|Cohort A 30 mcg P2-VP8|Healthy toddlers aged 2 to <3 yrs receiving an intermediate dose of P2-VP8
75574|NCT02109484|P2|Participant Flow|Cohort A 10 mcg P2-VP8|Healthy toddlers 2 to <3 yrs of age receiving low dose P2-VP8
75575|NCT02109484|P1|Participant Flow|Cohort A Placebo|Healthy toddlers aged 2 to <3 months receiving placebo
75583|NCT02109484|O4|Outcome|Cohort B 60 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving High Dose P2-VP8
75584|NCT02109484|O3|Outcome|Cohort B 30 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving Medium Dose P2-VP8 Medium Dose Infants
75585|NCT02109484|O2|Outcome|Cohort B 10 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving Low Dose P2-VP8
75586|NCT02109484|O1|Outcome|Cohort B Placebo|Healthy Infants aged 6 to <8 weeks receiving placebo
75587|NCT02109484|O4|Outcome|Cohort B 60 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving High Dose P2-VP8
75588|NCT02109484|O3|Outcome|Cohort B 30 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving Medium Dose P2-VP8
75589|NCT02109484|O2|Outcome|Cohort B 10 mcg P2-VP8|Healthy infants aged 6 to <8 weeks receiving low dose P2-VP8
75590|NCT02109484|O1|Outcome|Cohort B Placebo|Healthy Infants aged 6 to <8 weeks receiving placebo
75591|NCT02109484|O8|Outcome|Cohort B 60 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving High Dose Infants P2-VP8
75592|NCT02109484|O7|Outcome|Cohort B 30 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving Medium Dose P2-VP8
75593|NCT02109484|O6|Outcome|Cohort B 10 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving Low Dose P2-VP8
75594|NCT02109484|O5|Outcome|Cohort B Placebo|Healthy Infants aged 6 to <8 weeks receiving placebo
75595|NCT02109484|O4|Outcome|Cohort A 60 mcg P2-VP8|Healthy toddlers aged 2 to <3 months receiving High Dose P2-VP8
75596|NCT02109484|O3|Outcome|Cohort A 30 mcg P2-VP8|Healthy toddlers aged 2 to <3 months receiving Medium Dose P2-VP8
75597|NCT02109484|O2|Outcome|Cohort A 10 mcg P2-VP8|Healthy toddlers aged 2 to <3 months receiving Low Dose Toddlers P2-VP8
75598|NCT02109484|O1|Outcome|Cohort A Placebo|Healthy toddlers aged 2 to <3 months receiving placebo
75599|NCT02109484|O8|Outcome|Cohort B 60 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving High Dose P2-VP8
75600|NCT02109484|O7|Outcome|Cohort B 30 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving Medium Dose P2-VP8
75601|NCT02109484|O6|Outcome|Cohort B 10 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving Low Dose P2-VP8
75602|NCT02109484|O5|Outcome|Cohort B Placebo|Healthy Infants aged 6 to <8 weeks receiving Placebo
75603|NCT02109484|O4|Outcome|Cohort A 60 mcg P2-VP8|Healthy toddlers aged 2 to <3 years receiving High Dose P2-VP8
75604|NCT02109484|O3|Outcome|Cohort A 30 mcg P2-VP8|Healthy toddlers aged 2 to <3 years receiving Medium Dose P2-VP8
75605|NCT02109484|O2|Outcome|Cohort A 10 mcg P2-VP8|Healthy toddlers aged 2 to <3 years receiving Low Dose P2-VP8
75606|NCT02109484|O1|Outcome|Cohort A Placebo|Healthy toddlers aged 2 to <3 years receiving Placebo
75607|NCT02109484|O8|Outcome|Cohort B 60 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving High Dose P2-VP8
75608|NCT02109484|O7|Outcome|Cohort B 30 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving Medium Dose P2-VP8
75609|NCT02109484|O6|Outcome|Cohort B 10 mcg P2-VP8|Healthy infants aged 6 to < 8 weeks receiving Low Dose P2-VP8
75610|NCT02109484|O5|Outcome|Cohort B Placebo|Healthy Infants aged 6 to <8 weeks receiving placebo
75611|NCT02109484|O4|Outcome|Cohort A 60 mcg P2-VP8|Healthy toddlers aged 2 to <3 months receiving placebo High Dose P2-VP8
75612|NCT02109484|O3|Outcome|Cohort A 30 mcg P2-VP8|Healthy toddlers aged 2 to <3 months receiving Medium Dose P2-VP8
75613|NCT02109484|O2|Outcome|Cohort A 10 mcg P2-VP8|Healthy toddlers aged 2 to <3 months receiving low dose P2-VP8
75614|NCT02109484|O1|Outcome|Cohort A Placebo|Healthy toddlers aged 2 to <3 months receiving placebo
75615|NCT02109484|E8|Reported Event|Cohort B 60 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving High Dose P2-VP8
75616|NCT02109484|E7|Reported Event|Cohort B 30 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving Medium Dose P2-VP8
75617|NCT02109484|E6|Reported Event|Cohort B 10 mcg P2-VP8|Healthy Infants aged 6 to <8 weeks receiving Low Dose P2-VP8
75618|NCT02109484|E5|Reported Event|Cohort B Placebo|Healthy Infants aged 6 to <8 weeks receiving placebo
75619|NCT02109484|E4|Reported Event|Cohort A 60 mcg P2-VP8|Healthy toddlers aged 2 to <3 years receiving High Dose P2-VP8
75620|NCT02109484|E3|Reported Event|Cohort A 30 mcg P2-VP8|Healthy toddlers aged 2 to <3 years receiving Medium Dose P2-VP8
75621|NCT02109484|E2|Reported Event|Cohort A 10 mcg P2-VP8|Healthy toddlers aged 2 to <3 years receiving Low Dose P2-VP8
75622|NCT02109484|E1|Reported Event|Cohort A Placebo|Healthy toddlers aged 2 to <3 years receiving Placebo
75623|NCT02109458|B1|Baseline|Assessing Peripheral Pulmonary Nodules|"To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).~Navigation guided bronchoscopy"
75624|NCT02109458|P1|Participant Flow|Assessing Peripheral Pulmonary Nodules|"To evaluate the feasibility and safety of a procedure path including convex Endobronchial Ultrasound (EBUS) lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).~Navigation guided bronchoscopy"
75625|NCT02109458|O1|Outcome|Assessing Peripheral Pulmonary Nodules|"To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).~Navigation guided bronchoscopy"
75626|NCT02109458|O1|Outcome|Assessing Peripheral Pulmonary Nodules|"To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).~Navigation guided bronchoscopy"
75627|NCT02109458|O1|Outcome|Assessing Peripheral Pulmonary Nodules|"To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).~Navigation guided bronchoscopy"
75628|NCT02109458|O1|Outcome|Assessing Peripheral Pulmonary Nodules|"To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).~Navigation guided bronchoscopy"
75629|NCT02109458|E1|Reported Event|Assessing Peripheral Pulmonary Nodules|"To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).~Navigation guided bronchoscopy"
75630|NCT02109445|B1|Baseline|PF-03084014+Nab-Paclitaxel+Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75631|NCT02109445|P1|Participant Flow|PF-03084014+Nab-Paclitaxel+Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75632|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75633|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75634|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75635|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75636|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75637|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75638|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75639|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75640|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75641|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75677|NCT02109159|B2|Baseline|Control Video|a short online video (2”43 minutes long) about the WOMAN trial with less emotional content (the interviewer provides a second hand description of the experience)
76673|NCT02105285|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
75642|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75643|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75644|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75645|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75646|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75647|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75648|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75649|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75650|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75651|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75652|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75653|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75678|NCT02109159|B1|Baseline|Emotional Video|a short online video (2”43 minutes long) about the WOMAN trial with more emotional content (an interview with a postpartum haemorrhage survivor and her husband in which they describe their experience)
76674|NCT02105285|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
75654|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75655|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75656|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75657|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75658|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75659|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75660|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75661|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75662|NCT02109445|E1|Reported Event|PF-03084014+Nab-Paclitaxel+Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
75663|NCT02109172|B1|Baseline|Entire Study Population|All groups were randomized to receive placebo, TD-4208 44mcg twice daily, and TD-4208 175 mcg once daily
75664|NCT02109172|P6|Participant Flow|175mcg First, Then Placebo, Then 44mcg|175mcg once daily for 7 days then placebo twice daily for 7 days then 44mcg twice daily for 7 days
75665|NCT02109172|P5|Participant Flow|175mcg First, Then 44mcg, Then Placebo|175mcg once daily for 7 days then 44mcg twice daily for 7 days then placebo twice daily for 7 days
75666|NCT02109172|P4|Participant Flow|44mcg First, Then Placebo, Then 175mcg|44mcg twice daily for 7 days then placebo twice daily for 7 days then 175mcg once daily for 7 days
75667|NCT02109172|P3|Participant Flow|44mcg First, Then 175mcg, Then Placebo|44mcg twice daily for 7 days then 175mcg once daily for 7 days then placebo twice daily for 7 days
75668|NCT02109172|P2|Participant Flow|Placebo First, Then 175mcg, Then 44mcg|Placebo twice daily for 7 days then 175mcg once daily for 7 days then 44mcg twice daily for 7 days
75669|NCT02109172|P1|Participant Flow|Placebo First, Then 44mcg, Then 175mcg|Placebo twice daily for 7 days then 44mcg twice daily for 7 days then 175mcg once daily for 7 days
75670|NCT02109172|O3|Outcome|TD-4208 175 mcg Once Daily|"TD-4208 inhalation solution 175 mcg once daily, placebo once daily~TD-4208~Placebo"
75671|NCT02109172|O2|Outcome|TD-4208 44 mcg Twice Daily|"TD-4208 inhalation solution 44 mcg twice daily for 7 days~TD-4208"
75672|NCT02109172|O1|Outcome|Placebo|"Placebo inhalation solution twice daily for 7 days~Placebo"
75673|NCT02109172|E3|Reported Event|TD-4208 175mcg Once Daily|TD-4208 inhalation solution 175 mcg once daily
75674|NCT02109172|E2|Reported Event|TD-4208 44mcg Twice Daily|TD-4208 inhalation solution 44 mcg twice daily for 7 days
75675|NCT02109172|E1|Reported Event|Placebo|Placebo inhalation solution twice daily for 7 days
75676|NCT02109159|B3|Baseline|Total|Total of all reporting groups
75679|NCT02109159|P2|Participant Flow|Control Video|"A short online video with less emotional content, the interviewer provides a second hand description of the experience of a postpartum hemorrhage survivor and her husband.~A short online video with less emotional content"
75680|NCT02109159|P1|Participant Flow|Emotional Video|"A short online video with emotional content, an interview with a postpartum haemorrhage survivor and her husband in which they describe their experience.~A short online video with emotional content"
75681|NCT02109159|O2|Outcome|Control Video|"A short online video with less emotional content, the interviewer provides a second hand description of the experience of a postpartum hemorrhage survivor and her husband.~A short online video with less emotional content"
75682|NCT02109159|O1|Outcome|Emotional Video|"A short online video with emotional content, an interview with a postpartum haemorrhage survivor and her husband in which they describe their experience.~A short online video with emotional content"
75683|NCT02109159|O2|Outcome|Control Video|"A short online video with less emotional content, the interviewer provides a second hand description of the experience of a postpartum hemorrhage survivor and her husband.~A short online video with less emotional content"
75684|NCT02109159|O1|Outcome|Emotional Video|"A short online video with emotional content, an interview with a postpartum haemorrhage survivor and her husband in which they describe their experience.~A short online video with emotional content"
75685|NCT02109159|E2|Reported Event|Control Video|"A short online video with less emotional content, the interviewer provides a second hand description of the experience of a postpartum hemorrhage survivor and her husband.~A short online video with less emotional content"
75686|NCT02109159|E1|Reported Event|Emotional Video|"A short online video with emotional content, an interview with a postpartum haemorrhage survivor and her husband in which they describe their experience.~A short online video with emotional content"
75687|NCT02109133|B3|Baseline|Total|Total of all reporting groups
75688|NCT02109133|B2|Baseline|Deep Neuromuscular Blockade|"deep neuromuscular blockade: deep neuromuscular blockade using rocuronium and reverse with sugammadex~Rocuronium~Sugammadex"
75689|NCT02109133|B1|Baseline|Moderate Neuromuscular Blockade|"moderate neuromuscular blockade: moderate neuromuscular blockade using atracurium and reverse with neostigmine~Atracurium~Neostigmine"
75690|NCT02109133|P2|Participant Flow|Deep Neuromuscular Blockade (Deep NMB Group)|Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
75691|NCT02109133|P1|Participant Flow|Moderate Neuromuscular Blockade (Moderate NMB Group)|Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.
75692|NCT02109133|O2|Outcome|Deep Neuromuscular Blockade (Deep NMB Group)|Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
75693|NCT02109133|O1|Outcome|Moderate Neuromuscular Blockade (Moderate NMB Group)|Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.
75694|NCT02109133|O2|Outcome|Deep Neuromuscular Blockade (Deep NMB Group)|Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
75695|NCT02109133|O1|Outcome|Moderate Neuromuscular Blockade (Moderate NMB Group)|Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.
75696|NCT02109133|O2|Outcome|Deep Neuromuscular Blockade|"deep neuromuscular blockade: deep neuromuscular blockade using rocuronium and reverse with sugammadex~Rocuronium~Sugammadex"
75697|NCT02109133|O1|Outcome|Moderate Neuromuscular Blockade|"moderate neuromuscular blockade: moderate neuromuscular blockade using atracurium and reverse with neostigmine~Atracurium~Neostigmine"
75698|NCT02109133|O2|Outcome|Deep Neuromuscular Blockade (Deep NMB Group)|Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
75699|NCT02109133|O1|Outcome|Moderate Neuromuscular Blockade (Moderate NMB Group)|Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.
75700|NCT02109133|E2|Reported Event|Deep Neuromuscular Blockade|"deep neuromuscular blockade: deep neuromuscular blockade using rocuronium and reverse with sugammadex~Rocuronium~Sugammadex"
75701|NCT02109133|E1|Reported Event|Moderate Neuromuscular Blockade|"moderate neuromuscular blockade: moderate neuromuscular blockade using atracurium and reverse with neostigmine~Atracurium~Neostigmine"
75804|NCT02108223|B1|Baseline|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
75702|NCT02109107|B1|Baseline|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.~Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
75703|NCT02109107|P1|Participant Flow|Erchonia® Zerona 6 Headed Scanner (EZ6) Laser|"The Erchonia® Zerona 6 Headed Scanner (EZ6) Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.~Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
75704|NCT02109107|O1|Outcome|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.~Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
75705|NCT02109107|O1|Outcome|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.~Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
75706|NCT02109107|O1|Outcome|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.~Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
75707|NCT02109107|O1|Outcome|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.~Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
75708|NCT02109107|E1|Reported Event|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.~Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
75709|NCT02108977|B3|Baseline|Total|Total of all reporting groups
75710|NCT02108977|B2|Baseline|Telephone Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)~Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
75711|NCT02108977|B1|Baseline|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing~Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
75712|NCT02108977|P2|Participant Flow|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)~Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
75713|NCT02108977|P1|Participant Flow|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing~Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
75714|NCT02108977|O2|Outcome|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)~Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
75715|NCT02108977|O1|Outcome|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing~Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
75716|NCT02108977|O2|Outcome|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)~Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
75717|NCT02108977|O1|Outcome|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing~Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
75718|NCT02108977|O2|Outcome|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)~Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
75719|NCT02108977|O1|Outcome|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing~Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
75720|NCT02108977|O2|Outcome|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)~Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
75721|NCT02108977|O1|Outcome|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing~Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
75722|NCT02108977|E2|Reported Event|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)~Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
75723|NCT02108977|E1|Reported Event|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing~Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
75771|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
75724|NCT02108951|B1|Baseline|Nilotinib|Nilotinib was administered orally at 300 mg BD at approximately 12 hour intervals which had to be taken without food. The capsules were to be swallowed whole with water and no food should have been consumed for at least 2 hours before and at least 1 hour after the dose was taken. Prior to the first dose of nilotinib, patients were required to have an imatinib or dasatinib washout period of at least 3 days. Therapy with nilotinib was to be continued for up to 24 months while on study.
75725|NCT02108951|P1|Participant Flow|Nilotinib|Nilotinib was administered orally at 300 mg BD at approximately 12 hour intervals which had to be taken without food. The capsules were to be swallowed whole with water and no food should have been consumed for at least 2 hours before and at least 1 hour after the dose was taken. Prior to the first dose of nilotinib, patients were required to have an imatinib or dasatinib washout period of at least 3 days. Therapy with nilotinib was to be continued for up to 24 months while on study.
75726|NCT02108951|O1|Outcome|Nilotinib|Nilotinib was administered orally at 300 mg BD at approximately 12 hour intervals which had to be taken without food. The capsules were to be swallowed whole with water and no food should have been consumed for at least 2 hours before and at least 1 hour after the dose was taken. Prior to the first dose of nilotinib, patients were required to have an imatinib or dasatinib washout period of at least 3 days. Therapy with nilotinib was to be continued for up to 24 months while on study.
75727|NCT02108951|O1|Outcome|Nilotinib|Nilotinib was administered orally at 300 mg BD at approximately 12 hour intervals which had to be taken without food. The capsules were to be swallowed whole with water and no food should have been consumed for at least 2 hours before and at least 1 hour after the dose was taken. Prior to the first dose of nilotinib, patients were required to have an imatinib or dasatinib washout period of at least 3 days. Therapy with nilotinib was to be continued for up to 24 months while on study.
75728|NCT02108951|O1|Outcome|Nilotinib|Nilotinib was administered orally at 300 mg BD at approximately 12 hour intervals which had to be taken without food. The capsules were to be swallowed whole with water and no food should have been consumed for at least 2 hours before and at least 1 hour after the dose was taken. Prior to the first dose of nilotinib, patients were required to have an imatinib or dasatinib washout period of at least 3 days. Therapy with nilotinib was to be continued for up to 24 months while on study.
75729|NCT02108951|O1|Outcome|Nilotinib|Nilotinib was administered orally at 300 mg BD at approximately 12 hour intervals which had to be taken without food. The capsules were to be swallowed whole with water and no food should have been consumed for at least 2 hours before and at least 1 hour after the dose was taken. Prior to the first dose of nilotinib, patients were required to have an imatinib or dasatinib washout period of at least 3 days. Therapy with nilotinib was to be continued for up to 24 months while on study.
75730|NCT02108951|O1|Outcome|Nilotinib|Nilotinib was administered orally at 300 mg BD at approximately 12 hour intervals which had to be taken without food. The capsules were to be swallowed whole with water and no food should have been consumed for at least 2 hours before and at least 1 hour after the dose was taken. Prior to the first dose of nilotinib, patients were required to have an imatinib or dasatinib washout period of at least 3 days. Therapy with nilotinib was to be continued for up to 24 months while on study.
75731|NCT02108951|O1|Outcome|Nilotinib|Nilotinib was administered orally at 300 mg BD at approximately 12 hour intervals which had to be taken without food. The capsules were to be swallowed whole with water and no food should have been consumed for at least 2 hours before and at least 1 hour after the dose was taken. Prior to the first dose of nilotinib, patients were required to have an imatinib or dasatinib washout period of at least 3 days. Therapy with nilotinib was to be continued for up to 24 months while on study.
75732|NCT02108951|O1|Outcome|Nilotinib|Nilotinib was administered orally at 300 mg BD at approximately 12 hour intervals which had to be taken without food. The capsules were to be swallowed whole with water and no food should have been consumed for at least 2 hours before and at least 1 hour after the dose was taken. Prior to the first dose of nilotinib, patients were required to have an imatinib or dasatinib washout period of at least 3 days. Therapy with nilotinib was to be continued for up to 24 months while on study.
75733|NCT02108951|O1|Outcome|Nilotinib|Nilotinib was administered orally at 300 mg BD at approximately 12 hour intervals which had to be taken without food. The capsules were to be swallowed whole with water and no food should have been consumed for at least 2 hours before and at least 1 hour after the dose was taken. Prior to the first dose of nilotinib, patients were required to have an imatinib or dasatinib washout period of at least 3 days. Therapy with nilotinib was to be continued for up to 24 months while on study.
75734|NCT02108951|O1|Outcome|Nilotinib|Nilotinib was administered orally at 300 mg BD at approximately 12 hour intervals which had to be taken without food. The capsules were to be swallowed whole with water and no food should have been consumed for at least 2 hours before and at least 1 hour after the dose was taken. Prior to the first dose of nilotinib, patients were required to have an imatinib or dasatinib washout period of at least 3 days. Therapy with nilotinib was to be continued for up to 24 months while on study.
75735|NCT02108951|O1|Outcome|Nilotinib|Nilotinib was administered orally at 300 mg BD at approximately 12 hour intervals which had to be taken without food. The capsules were to be swallowed whole with water and no food should have been consumed for at least 2 hours before and at least 1 hour after the dose was taken. Prior to the first dose of nilotinib, patients were required to have an imatinib or dasatinib washout period of at least 3 days. Therapy with nilotinib was to be continued for up to 24 months while on study.
75736|NCT02108951|O1|Outcome|Nilotinib|Nilotinib was administered orally at 300 mg BD at approximately 12 hour intervals which had to be taken without food. The capsules were to be swallowed whole with water and no food should have been consumed for at least 2 hours before and at least 1 hour after the dose was taken. Prior to the first dose of nilotinib, patients were required to have an imatinib or dasatinib washout period of at least 3 days. Therapy with nilotinib was to be continued for up to 24 months while on study.
75737|NCT02108951|O1|Outcome|Nilotinib|Nilotinib was administered orally at 300 mg BD at approximately 12 hour intervals which had to be taken without food. The capsules were to be swallowed whole with water and no food should have been consumed for at least 2 hours before and at least 1 hour after the dose was taken. Prior to the first dose of nilotinib, patients were required to have an imatinib or dasatinib washout period of at least 3 days. Therapy with nilotinib was to be continued for up to 24 months while on study.
75805|NCT02108223|P3|Participant Flow|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
75738|NCT02108951|O1|Outcome|Nilotinib|Nilotinib was administered orally at 300 mg BD at approximately 12 hour intervals which had to be taken without food. The capsules were to be swallowed whole with water and no food should have been consumed for at least 2 hours before and at least 1 hour after the dose was taken. Prior to the first dose of nilotinib, patients were required to have an imatinib or dasatinib washout period of at least 3 days. Therapy with nilotinib was to be continued for up to 24 months while on study.
75739|NCT02108951|O1|Outcome|Nilotinib|Nilotinib was administered orally at 300 mg BD at approximately 12 hour intervals which had to be taken without food. The capsules were to be swallowed whole with water and no food should have been consumed for at least 2 hours before and at least 1 hour after the dose was taken. Prior to the first dose of nilotinib, patients were required to have an imatinib or dasatinib washout period of at least 3 days. Therapy with nilotinib was to be continued for up to 24 months while on study.
75740|NCT02108951|E1|Reported Event|Nilotinib|Nilotinib was administered orally at 300 mg BD at approximately 12 hour intervals which had to be taken without food. The capsules were to be swallowed whole with water and no food should have been consumed for at least 2 hours before and at least 1 hour after the dose was taken. Prior to the first dose of nilotinib, patients were required to have an imatinib or dasatinib washout period of at least 3 days. Therapy with nilotinib was to be continued for up to 24 months while on study
75741|NCT02108691|B3|Baseline|Total|Total of all reporting groups
75742|NCT02108691|B2|Baseline|Placebo|Placebo: Placebo (2.5g/day)
75743|NCT02108691|B1|Baseline|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
75744|NCT02108691|P2|Participant Flow|Placebo|Placebo: Placebo (2.5g/day)
75745|NCT02108691|P1|Participant Flow|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
75746|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
75747|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
75748|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
75749|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
75750|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
75751|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
75752|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
75753|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
75754|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
75755|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
75756|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
75757|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
75758|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
75759|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
75760|NCT02108691|E2|Reported Event|Placebo|Placebo: Placebo (2.5g/day)
75761|NCT02108691|E1|Reported Event|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
75762|NCT02108652|B1|Baseline|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
75763|NCT02108652|P1|Participant Flow|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
75764|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
75765|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
75766|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
75767|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
75768|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
75769|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
75770|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
75772|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
75773|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
75774|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
75775|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
75776|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
75777|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
75778|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
75779|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
75780|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
75781|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
75782|NCT02108652|E1|Reported Event|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
75783|NCT02108288|B4|Baseline|Total|Total of all reporting groups
75784|NCT02108288|B3|Baseline|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
75785|NCT02108288|B2|Baseline|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
75786|NCT02108288|B1|Baseline|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
75787|NCT02108288|P3|Participant Flow|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
75788|NCT02108288|P2|Participant Flow|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
75789|NCT02108288|P1|Participant Flow|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
75790|NCT02108288|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
75791|NCT02108288|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
75792|NCT02108288|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
75793|NCT02108288|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
75794|NCT02108288|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
75795|NCT02108288|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
75796|NCT02108288|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
75797|NCT02108288|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
75798|NCT02108288|E3|Reported Event|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
75799|NCT02108288|E2|Reported Event|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
75800|NCT02108288|E1|Reported Event|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
75801|NCT02108223|B4|Baseline|Total|Total of all reporting groups
75802|NCT02108223|B3|Baseline|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
75803|NCT02108223|B2|Baseline|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
75858|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75806|NCT02108223|P2|Participant Flow|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
75807|NCT02108223|P1|Participant Flow|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
75808|NCT02108223|O3|Outcome|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
75809|NCT02108223|O2|Outcome|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
75810|NCT02108223|O1|Outcome|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
75811|NCT02108223|O3|Outcome|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
75812|NCT02108223|O2|Outcome|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
75813|NCT02108223|O1|Outcome|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
75814|NCT02108223|O3|Outcome|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
75815|NCT02108223|O2|Outcome|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
75816|NCT02108223|O1|Outcome|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
75817|NCT02108223|O3|Outcome|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
75818|NCT02108223|O2|Outcome|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
75819|NCT02108223|O1|Outcome|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
75820|NCT02108223|O3|Outcome|r-FSH (Gonal-f) Group 3|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
75821|NCT02108223|O2|Outcome|r-LH Supplementation to r-FSH Group 2|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
75822|NCT02108223|O1|Outcome|Fix Dose r-FSH (Gonal-f) Group 1|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
75823|NCT02108223|E3|Reported Event|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
75824|NCT02108223|E2|Reported Event|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
75825|NCT02108223|E1|Reported Event|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
75826|NCT02108171|B3|Baseline|Total|Total of all reporting groups
75827|NCT02108171|B2|Baseline|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
78033|NCT02096900|O2|Outcome|Zolpidem|zolpidem was given orally 0.25mg/kg pre-operatively single dose
75828|NCT02108171|B1|Baseline|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75829|NCT02108171|P2|Participant Flow|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75830|NCT02108171|P1|Participant Flow|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75831|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75832|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75833|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75834|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75835|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75836|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75837|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75838|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75839|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75840|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75841|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75842|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75843|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75844|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75845|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75846|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75847|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75848|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75849|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75850|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75851|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75852|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75853|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75854|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75855|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75856|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75857|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75859|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75860|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75861|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75862|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75863|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75864|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75865|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75866|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75867|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75868|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75869|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75870|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75871|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75872|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75873|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75874|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75875|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75876|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75877|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75878|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75879|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75880|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75881|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75882|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75883|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75884|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75885|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75886|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75887|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75888|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75889|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75890|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75891|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75892|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75893|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75894|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75895|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75896|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75897|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75898|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75899|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75900|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75901|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75902|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75903|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75904|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75905|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75906|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75907|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75908|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75909|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75910|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75911|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75912|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75913|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75914|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75915|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75916|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75917|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75918|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75919|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75920|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75921|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75922|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75923|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75924|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75925|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75926|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75927|NCT02108171|E2|Reported Event|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75928|NCT02108171|E1|Reported Event|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
75929|NCT02107898|B3|Baseline|Total|Total of all reporting groups
75930|NCT02107898|B2|Baseline|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
75931|NCT02107898|B1|Baseline|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
75932|NCT02107898|P2|Participant Flow|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
75933|NCT02107898|P1|Participant Flow|Placebo Q2W|Placebo (for alirocumab) subcutaneous (SC) injection every two weeks (Q2W) added to stable lipid-modifying therapy (LMT) for 52 weeks.
75934|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
75935|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
75936|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
75937|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
75938|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
75939|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
75940|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
75941|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
75942|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
75943|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
75944|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
75945|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
75946|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
75947|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
76052|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
75948|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
75949|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
75950|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
75951|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
75952|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
75953|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
75954|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
75955|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
75956|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
75957|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
75958|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
75959|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
75960|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
75961|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
75962|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
75963|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
75964|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
75965|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
75966|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
75967|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
75968|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
75969|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
75970|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
75971|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
75972|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
75973|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
75974|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
75975|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
75976|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
75977|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
75978|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
75979|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
75980|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
75981|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
75982|NCT02107898|E2|Reported Event|Alirocumab 75 mg/ Up to 150 mg Q2W|Participants exposed to alirocumab 75 mg /up to 150 mg SC injection Q2W added to stable LMT (mean exposition of 50 weeks).
75983|NCT02107898|E1|Reported Event|Placebo Q2W|Participants exposed to placebo (for alirocumab) SC injection Q2W added to stable LMT (mean exposition of 50 weeks).
75984|NCT02107703|B3|Baseline|Total|Total of all reporting groups
75985|NCT02107703|B2|Baseline|Placebo + Fulvestrant|Placebo supplied as capsules administered orally every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
75986|NCT02107703|B1|Baseline|Abemaciclib + Fulvestrant|150 mg Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
75987|NCT02107703|P2|Participant Flow|Placebo + Fulvestrant|Placebo supplied as capsules administered orally every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
75988|NCT02107703|P1|Participant Flow|Abemaciclib + Fulvestrant|150 milligrams (mg) Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
75989|NCT02107703|O2|Outcome|Placebo + Fulvestrant|Placebo will be supplied as capsules administered orally every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
75990|NCT02107703|O1|Outcome|Abemaciclib + Fulvestrant|150 milligrams (mg) Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
75991|NCT02107703|O2|Outcome|Placebo + Fulvestrant|Placebo will be supplied as capsules administered orally every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
75992|NCT02107703|O1|Outcome|Abemaciclib + Fulvestrant|150 milligrams (mg) Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
75993|NCT02107703|O2|Outcome|Placebo + Fulvestrant|Placebo will be supplied as capsules administered orally every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
75994|NCT02107703|O1|Outcome|Abemaciclib + Fulvestrant|150 milligrams (mg) Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
75995|NCT02107703|O1|Outcome|Abemaciclib + Fulvestrant|150 milligrams (mg) Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond.
75996|NCT02107703|O2|Outcome|Placebo + Fulvestrant|Placebo will be supplied as capsules administered orally every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
75997|NCT02107703|O1|Outcome|Abemaciclib + Fulvestrant|150 milligrams (mg) Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
75998|NCT02107703|O2|Outcome|Placebo + Fulvestrant|Placebo will be supplied as capsules administered orally every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
75999|NCT02107703|O1|Outcome|Abemaciclib + Fulvestrant|150 milligrams (mg) Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
76000|NCT02107703|O2|Outcome|Placebo + Fulvestrant|Placebo will be supplied as capsules administered orally every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
76053|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
76001|NCT02107703|O1|Outcome|Abemaciclib + Fulvestrant|150 milligrams (mg) Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
76002|NCT02107703|O2|Outcome|Placebo + Fulvestrant|Placebo will be supplied as capsules administered orally every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
76003|NCT02107703|O1|Outcome|Abemaciclib + Fulvestrant|150 milligrams (mg) Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
76004|NCT02107703|O2|Outcome|Placebo + Fulvestrant|Placebo supplied as capsules administered orally every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
76005|NCT02107703|O1|Outcome|Abemaciclib + Fulvestrant|150 mg Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
76006|NCT02107703|O2|Outcome|Placebo + Fulvestrant|Placebo supplied as capsules administered orally every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
76007|NCT02107703|O1|Outcome|Abemaciclib + Fulvestrant|150 mg Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
76008|NCT02107703|O2|Outcome|Placebo + Fulvestrant|Placebo supplied as capsules administered orally every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
76009|NCT02107703|O1|Outcome|Abemaciclib + Fulvestrant|150 mg Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
76010|NCT02107703|E2|Reported Event|Placebo + Fulvestrant|Placebo will be supplied as capsules administered orally every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
76011|NCT02107703|E1|Reported Event|Abemaciclib + Fulvestrant|150 milligrams (mg) Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
76012|NCT02107599|B1|Baseline|Florbetapir PET Scans|No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A16) and 50 randomly selected non-autopsy scans (A17).
76013|NCT02107599|P1|Participant Flow|Florbetapir PET Scans|No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A16) and 50 randomly selected non-autopsy scans (A17).
76014|NCT02107599|O3|Outcome|Non-autopsy Cases|Only 50 non-autopsy scans from A17.
76015|NCT02107599|O2|Outcome|Autopsy Cases|Only 46 autopsy scans from A16.
76016|NCT02107599|O1|Outcome|All Study Cases|All 96 scans from A16 and A17.
76017|NCT02107599|O1|Outcome|Physician Readers|All 21 physician readers.
76018|NCT02107599|E1|Reported Event|Florbetapir PET Scans|No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A16) and 50 randomly selected non-autopsy scans (A17).
76019|NCT02107482|B1|Baseline|All Participants - Levia Narrow Band UVB|Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, skin type VI: starting dose of 600 mj/cm2). The dose will be increased by 15% with each treatment, as long as there are no side effects with treatment such as burning or redness. The same subject will have a second target lesion treated with the Sham Comparator.
76020|NCT02107482|P1|Participant Flow|All Participants|Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, skin type VI: starting dose of 600 mj/cm2). The dose will be increased by 15% with each treatment, as long as there are no side effects with treatment such as burning or redness. The same subject will have a second target lesion treated with the Sham Comparator.
76021|NCT02107482|O1|Outcome|All Participants|Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, skin type VI: starting dose of 600 mj/cm2). The dose will be increased by 15% with each treatment, as long as there are no side effects with treatment such as burning or redness. The same subject will have a second target lesion treated with the Sham Comparator.
76054|NCT02107339|E2|Reported Event|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
78034|NCT02096900|O1|Outcome|Midazolam|midazolam was given at 0.5mg/kg, pre-operatively single dose
76022|NCT02107482|O1|Outcome|All Participants|Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, skin type VI: starting dose of 600 mj/cm2). The dose will be increased by 15% with each treatment, as long as there are no side effects with treatment such as burning or redness. The same subject will have a second target lesion treated with the Sham Comparator.
76023|NCT02107482|O1|Outcome|All Participants|Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, skin type VI: starting dose of 600 mj/cm2). The dose will be increased by 15% with each treatment, as long as there are no side effects with treatment such as burning or redness. The same subject will have a second target lesion treated with the Sham Comparator.
76024|NCT02107482|E1|Reported Event|All Participants|Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, skin type VI: starting dose of 600 mj/cm2). The dose will be increased by 15% with each treatment, as long as there are no side effects with treatment such as burning or redness. The same subject will have a second target lesion treated with the Sham Comparator.
76025|NCT02107339|B3|Baseline|Total|Total of all reporting groups
76026|NCT02107339|B2|Baseline|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
76027|NCT02107339|B1|Baseline|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
76028|NCT02107339|P2|Participant Flow|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
76029|NCT02107339|P1|Participant Flow|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
76030|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
76031|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
76032|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
76033|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
76034|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
76035|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
76036|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
76037|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
76038|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
76039|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
76040|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
76041|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
76042|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
76043|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
76044|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
76045|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
76046|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
76047|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
76048|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
76049|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
76050|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
76051|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
76055|NCT02107339|E1|Reported Event|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
76056|NCT02107313|B1|Baseline|All Study Participants|Participants are first administered PBT2 250 mg orally following a period of fasting for 10 hours and a high fat breakfast in the FED cohort. Participants then cross over into the FASTED Cohort and receive PBT2 250 mg orally after a period of fasting of 10 hours and without food.
76057|NCT02107313|P2|Participant Flow|Fasted Cohort First Then Fed Cohort|"Per sequence, FASTED Cohort first, then FED Cohort.~Nine participants in the Fasted Cohort. PBT2 250 mg is administered orally following a 10 hour period of fasting and without food first. Participants then cross over into the FED Cohort."
76058|NCT02107313|P1|Participant Flow|Fed Cohort First Then Fasted Cohort|"Per sequence, FED Cohort first then FASTED Cohort.~Nine participants in the FED Cohort. PBT2 250 mg is administered orally following a high fat breakfast first, following a period of fasting for 10 hours and a high fat breakfast. Participants then cross over into the FASTED Cohort."
76059|NCT02107313|O2|Outcome|Fasted Cohort|"PBT2 250 mg is administered orally following a 10 hour period of fasting~Fasted Cohort PBT2: PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food. Participants cross over to the FED cohort after completing the Fasted Cohort."
76060|NCT02107313|O1|Outcome|Fed Cohort|"PBT2 250 mg is administered orally following a high fat breakfast~Fed Cohort PBT2: PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast. Participants cross over to the FASTED cohort after completing the Fed Cohort."
76061|NCT02107313|O2|Outcome|Fasted Cohort|"PBT2 250 mg is administered orally following a 10 hour period of fasting~Fasted Cohort PBT2: PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food. Participants cross over to the FED cohort after completing the Fasted Cohort."
76062|NCT02107313|O1|Outcome|Fed Cohort|"PBT2 250 mg is administered orally following a high fat breakfast~Fed Cohort PBT2: PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast. Participants cross over to the FASTED cohort after completing the Fed Cohort."
76063|NCT02107313|E2|Reported Event|Fasted Cohort|"PBT2 250 mg is administered orally following a 10 hour period of fasting~Fasted Cohort PBT2: PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food. Participants cross over to the FED cohort after completing the Fasted Cohort."
76064|NCT02107313|E1|Reported Event|Fed Cohort|"PBT2 250 mg is administered orally following a high fat breakfast~Fed Cohort PBT2: PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast. Participants cross over to the FASTED cohort after completing the Fed Cohort."
76065|NCT02107274|B3|Baseline|Total|Total of all reporting groups
76066|NCT02107274|B2|Baseline|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
76067|NCT02107274|B1|Baseline|Azithromycin|Patients randomised to the treatment arm received 1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
76068|NCT02107274|P2|Participant Flow|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
76069|NCT02107274|P1|Participant Flow|Azithromycin and Placebo for Azithromycin|Patients randomised to the treatment arm received 1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
76070|NCT02107274|O2|Outcome|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
76071|NCT02107274|O1|Outcome|Azithromycin|Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
76072|NCT02107274|O2|Outcome|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
76073|NCT02107274|O1|Outcome|Azithromycin|Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
76074|NCT02107274|O2|Outcome|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
76075|NCT02107274|O1|Outcome|Azithromycin|Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
76076|NCT02107274|O2|Outcome|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
76077|NCT02107274|O1|Outcome|Azithromycin|Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
76078|NCT02107274|E2|Reported Event|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
76079|NCT02107274|E1|Reported Event|Azithromycin|Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
76080|NCT02107196|B3|Baseline|Total|Total of all reporting groups
76081|NCT02107196|B2|Baseline|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
76082|NCT02107196|B1|Baseline|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
76169|NCT02106962|O2|Outcome|Topical Tranexamic Acid 25 %|Measure clotting time of Native arteriovenous fistula using Tranexamic acid 25% compared with normal clotting time
76083|NCT02107196|P2|Participant Flow|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomized to the placebo arm will be mock-re-randomized (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
76084|NCT02107196|P1|Participant Flow|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomized to the ibodutant 10 mg arm will be re-randomized at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
76085|NCT02107196|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
76086|NCT02107196|O2|Outcome|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
76087|NCT02107196|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
76088|NCT02107196|O2|Outcome|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
76089|NCT02107196|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
76090|NCT02107196|O2|Outcome|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
76091|NCT02107196|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
76092|NCT02107196|O2|Outcome|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
76093|NCT02107196|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
76094|NCT02107196|E2|Reported Event|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
76095|NCT02107196|E1|Reported Event|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
76096|NCT02107014|B1|Baseline|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76097|NCT02107014|P1|Participant Flow|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76098|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76099|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76100|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76101|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76170|NCT02106962|O1|Outcome|Topical Tranexamic Acid 5%|Measure clotting time of Native arteriovenous fistula after applying topical Tranexamic Acid 5% compared with normal clotting time
76102|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76103|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76104|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76105|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76106|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76107|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76108|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76109|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76110|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76111|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76112|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76113|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76114|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76115|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76116|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76117|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76199|NCT02106923|O4|Outcome|Empa/ 1000 mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
76118|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76119|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76120|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76121|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76122|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76123|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76124|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76125|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76126|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76127|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76128|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76129|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76130|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76131|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76132|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76133|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76200|NCT02106923|O3|Outcome|Empa/1000 mg Glumetza ® (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
76134|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76135|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76136|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76137|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76138|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76139|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76140|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76141|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76142|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76143|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76144|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76145|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76146|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76147|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76148|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76149|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76201|NCT02106923|O2|Outcome|Empa/ 1000 mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
76150|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76151|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76152|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76153|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76154|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76155|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76156|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76157|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76158|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76159|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76160|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76161|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76162|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76163|NCT02107014|E1|Reported Event|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
76164|NCT02106962|B3|Baseline|Total|Total of all reporting groups
76165|NCT02106962|B2|Baseline|Tranexamic Acid and Bacitracin 25%|Topical Tranexamic Acid 25% with bacitracin applied to the arterio-venous fistula site after completing dialysis, to measure clotting time in the same participants that received treatment but at a subsequent dialysis session.
76166|NCT02106962|B1|Baseline|Topical Tranexamic Acid and Bacitracin 5%|Topical Tranexamic Acid 5% with bacitracin applied to the arterio-venous fistula site after completing dialysis, to measure clotting time in the same participants that did not receive treatment at a subsequent dialysis session
76167|NCT02106962|P2|Participant Flow|Topical Tranexamic Acid 25%|Topical Tranexamic Acid 25% with bacitracin applied to the arterio-venous fistula site after completing dialysis, to measure clotting time.
76168|NCT02106962|P1|Participant Flow|Topical Tranexamic Acid 5%|Topical Tranexamic Acid 5% with bacitracin applied to the arterio-venous fistula site after completing dialysis, to measure clotting time.
76171|NCT02106962|O2|Outcome|Clotting Time Using Tranexamic Acid 25%|"Measure Native AV Fistula clotting time after dialysis using 25% Tranxemic Acid compared to normal clotting time of native AV Fistula after dialysis~Topical Tranexamic Acid 25% with bacitracin: Selected participants received a fixed amount of tranexamic acid 25%and bacitracin applied with compression up to 3 times (13 minutes total) per hemodialysis fistula needle site."
76172|NCT02106962|O1|Outcome|Clotting Time Using Tranexamic Acid 5%|"Measure Native AV Fistula clotting time after dialysis using 5% Tranexamic Acid compared to normal Clotting time of Native AV Fistula after dialysis~Topical Tranexamic Acid 5% with bacitracin: Selected participants received a fixed amount of tranexamic acid 5 %and bacitracin applied with compression up to 3 times (13 minutes total) per hemodialysis fistula needle site."
76173|NCT02106962|E2|Reported Event|Topical Tranexamic Acid 25% and Bacitracin|Topical Tranexamic Acid 25% with bacitracin was applied to the arterio-venous fistula site after completing dialysis, to measure clotting time at a subsequent dialysis session.
76174|NCT02106962|E1|Reported Event|Topical Tranexamic Acid 5% and Bacitracin|Topical Tranexamic Acid 5% with bacitracin applied to the arterio-venous fistula site after completing dialysis, to measure clotting time.
76175|NCT02106923|B4|Baseline|Total|Total of all reporting groups
76176|NCT02106923|B3|Baseline|1500mg, Fasted|Patients orally administered either 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC or 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h
76177|NCT02106923|B2|Baseline|1000mg, Fed|Patients orally administered either 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC or 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after a high-fat, high-caloric meal
76178|NCT02106923|B1|Baseline|1000mg, Fasted|Patients orally administered either 1 x 10 mg Empagliflozin/1000 mg metformin (Met) XR FDC or 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 hours (h).
76179|NCT02106923|P6|Participant Flow|Empa+1500mg Glumetza / Empa+1500mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR followed by oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h.
76180|NCT02106923|P5|Participant Flow|Empa+1500mg Met FDC / Empa+1500mg Glumetza (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC followed by oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h.
76181|NCT02106923|P4|Participant Flow|Empa+1000mg Glumetza / Empa+1000mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR followed by oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC. Both treatments were taken with 240 mL of water after a high-fat, high-caloric meal.
76182|NCT02106923|P3|Participant Flow|Empa+1000mg Met FDC / Empa+1000mg Glumetza (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC followed by oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after a high-fat, high-caloric meal.
76183|NCT02106923|P2|Participant Flow|Empa+1000mg Glumetza / Empa+1000mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR followed by oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR FDC. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h.
76184|NCT02106923|P1|Participant Flow|Empa+1000mg Met FDC / Empa+1000mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin (Empa)/1000 mg metformin (Met) extended release (XR) fixed dose combination (FDC) followed by oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 hours (h).
76185|NCT02106923|O6|Outcome|Empa/ 1500 mg Met FDC (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
76186|NCT02106923|O5|Outcome|Empa/ 1500 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
76187|NCT02106923|O4|Outcome|Empa/ 1000 mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
76188|NCT02106923|O3|Outcome|Empa/1000 mg Glumetza ® (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
76189|NCT02106923|O2|Outcome|Empa/ 1000 mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
76190|NCT02106923|O1|Outcome|Empa/1000 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
76191|NCT02106923|O6|Outcome|Empa/ 1500 mg Met FDC (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
76192|NCT02106923|O5|Outcome|Empa/ 1500 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
76193|NCT02106923|O4|Outcome|Empa/ 1000 mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
76194|NCT02106923|O3|Outcome|Empa/1000 mg Glumetza ® (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
76195|NCT02106923|O2|Outcome|Empa/ 1000 mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
76196|NCT02106923|O1|Outcome|Empa/1000 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
76197|NCT02106923|O6|Outcome|Empa/ 1500 mg Met FDC (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
76198|NCT02106923|O5|Outcome|Empa/ 1500 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
76202|NCT02106923|O1|Outcome|Empa/1000 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
76203|NCT02106923|O6|Outcome|Empa/ 1500 mg Met FDC (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
76204|NCT02106923|O5|Outcome|Empa/ 1500 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
76205|NCT02106923|O4|Outcome|Empa/ 1000 mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
76206|NCT02106923|O3|Outcome|Empa/1000 mg Glumetza ® (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
76207|NCT02106923|O2|Outcome|Empa/ 1000 mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
76208|NCT02106923|O1|Outcome|Empa/1000 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
76209|NCT02106923|O6|Outcome|Empa/ 1500 mg Met FDC (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
76210|NCT02106923|O5|Outcome|Empa/ 1500 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
76211|NCT02106923|O4|Outcome|Empa/ 1000 mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
76212|NCT02106923|O3|Outcome|Empa/1000 mg Glumetza ® (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
76213|NCT02106923|O2|Outcome|Empa/ 1000 mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
76214|NCT02106923|O1|Outcome|Empa/1000 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
76215|NCT02106923|O6|Outcome|Empa/ 1500 mg Met FDC (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
76216|NCT02106923|O5|Outcome|Empa/ 1500 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
76217|NCT02106923|O4|Outcome|Empa/ 1000 mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
76218|NCT02106923|O3|Outcome|Empa/1000 mg Glumetza ® (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
76219|NCT02106923|O2|Outcome|Empa/ 1000 mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
76220|NCT02106923|O1|Outcome|Empa/1000 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
76221|NCT02106923|E6|Reported Event|Empa/ 1500 mg Met FDC (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
76222|NCT02106923|E5|Reported Event|Empa/ 1500 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
76223|NCT02106923|E4|Reported Event|Empa/ 1000 mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
76224|NCT02106923|E3|Reported Event|Empa/1000 mg Glumetza ® (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
76225|NCT02106923|E2|Reported Event|Empa/ 1000 mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
76226|NCT02106923|E1|Reported Event|Empa/1000 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
76227|NCT02106832|B5|Baseline|Total|Total of all reporting groups
76228|NCT02106832|B4|Baseline|Placebo 14 Days on/Off (Placebo 14)|Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
76229|NCT02106832|B3|Baseline|Placebo 28 Days on/Off (Placebo 28)|Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
76230|NCT02106832|B2|Baseline|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
76231|NCT02106832|B1|Baseline|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
76232|NCT02106832|P4|Participant Flow|Placebo 14 Days on/Off (Placebo 14)|Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
76313|NCT02106403|O1|Outcome|Prototype Disinfectant Spray Formulation|0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
76233|NCT02106832|P3|Participant Flow|Placebo 28 Days on/Off (Placebo 28)|Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
76234|NCT02106832|P2|Participant Flow|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
76235|NCT02106832|P1|Participant Flow|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
76236|NCT02106832|O2|Outcome|Pooled Placebo|Subjects received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).
76237|NCT02106832|O1|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
76238|NCT02106832|O4|Outcome|Placebo 14 Days on/Off (Placebo 14)|Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
76239|NCT02106832|O3|Outcome|Placebo 28 Days on/Off (Placebo 28)|Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
76240|NCT02106832|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
76241|NCT02106832|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
76242|NCT02106832|O4|Outcome|Placebo 14 Days on/Off (Placebo 14)|Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
76243|NCT02106832|O3|Outcome|Placebo 28 Days on/Off (Placebo 28)|Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
76244|NCT02106832|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
76245|NCT02106832|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
76246|NCT02106832|O3|Outcome|Pooled Placebo|Subjects received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).
76247|NCT02106832|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
76248|NCT02106832|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
76249|NCT02106832|O4|Outcome|Placebo 14 Days on/Off (Placebo 14)|Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
76250|NCT02106832|O3|Outcome|Placebo 28 Days on/Off (Placebo 28)|Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
76251|NCT02106832|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
76252|NCT02106832|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
76285|NCT02106494|B2|Baseline|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC + Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
76253|NCT02106832|O3|Outcome|Pooled Placebo|Subjects received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).
76254|NCT02106832|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
76255|NCT02106832|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
76256|NCT02106832|O3|Outcome|Pooled Placebo|Subjects received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).
76257|NCT02106832|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
76258|NCT02106832|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
76259|NCT02106832|O3|Outcome|Pooled Placebo|Subjects received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).
76260|NCT02106832|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
76261|NCT02106832|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
76262|NCT02106832|O2|Outcome|Pooled Placebo|Subjects received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).
76263|NCT02106832|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
76264|NCT02106832|E3|Reported Event|Pooled Placebo|Subjects received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).
76265|NCT02106832|E2|Reported Event|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
76266|NCT02106832|E1|Reported Event|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Subjects received ciprofloxacin (BAYQ3939) 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
76267|NCT02106728|B3|Baseline|Total|Total of all reporting groups
76268|NCT02106728|B2|Baseline|Supportive Family Therapy|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
76269|NCT02106728|B1|Baseline|Multi-Family Therapy|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
76270|NCT02106728|P2|Participant Flow|Supportive Family Therapy|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
76286|NCT02106494|B1|Baseline|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for ondansetron IV + Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
76271|NCT02106728|P1|Participant Flow|Multi-Family Therapy|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
76272|NCT02106728|O6|Outcome|Supportive Family Therapy (Approximately 10 WEEKS)|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
76273|NCT02106728|O5|Outcome|Multi-Family Therapy (8WEEKS)|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
76274|NCT02106728|O4|Outcome|Supportive Family Therapy (POST)|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
76275|NCT02106728|O3|Outcome|Multi-Family Therapy (POST)|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
76276|NCT02106728|O2|Outcome|Supportive Family Therapy (PRE)|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
76277|NCT02106728|O1|Outcome|Multi-Family Therapy (PRE)|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
76278|NCT02106728|O2|Outcome|Supportive Family Therapy|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
76279|NCT02106728|O1|Outcome|Multi-Family Therapy|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
76280|NCT02106728|O2|Outcome|Supportive Family Therapy|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
76281|NCT02106728|O1|Outcome|Multi-Family Therapy|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
76282|NCT02106728|E2|Reported Event|Supportive Family Therapy|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
76283|NCT02106728|E1|Reported Event|Multi-Family Therapy|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
76284|NCT02106494|B3|Baseline|Total|Total of all reporting groups
76287|NCT02106494|P2|Participant Flow|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
76288|NCT02106494|P1|Participant Flow|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for Ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
76289|NCT02106494|O2|Outcome|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
76290|NCT02106494|O1|Outcome|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for Ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
76291|NCT02106494|O2|Outcome|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
76292|NCT02106494|O1|Outcome|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for Ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
76293|NCT02106494|O2|Outcome|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
76294|NCT02106494|O1|Outcome|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for Ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
76295|NCT02106494|O2|Outcome|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
76296|NCT02106494|O1|Outcome|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for Ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
76297|NCT02106494|O2|Outcome|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC + Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
76298|NCT02106494|O1|Outcome|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
76299|NCT02106494|E2|Reported Event|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
76300|NCT02106494|E1|Reported Event|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
76301|NCT02106403|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline characteristics
76302|NCT02106403|P6|Participant Flow|Sequence 6|Negative control was sprayed twice on the first wound, followed by Reference product sprayed twice on the second wound and Prototype Disinfectant Spray twice sprayed on the third wound. At least 30 min interval was allowed between prior and next product application.
76303|NCT02106403|P5|Participant Flow|Sequence 5|Negative control was sprayed twice on the first wound, followed by Prototype Disinfectant Spray twice sprayed on the second wound and Reference product sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.
76304|NCT02106403|P4|Participant Flow|Sequence 4|Reference product was sprayed twice on the first wound, followed by Negative control sprayed twice on the second wound and subsequently prototype disinfectant spray was twice sprayed on the third wound. At least 30 min interval was allowed between prior and next product application.
76305|NCT02106403|P3|Participant Flow|Sequence 3|Reference product was sprayed twice on the first wound, followed by Prototype Disinfectant Spray twice sprayed on the second wound and Negative control sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.
76306|NCT02106403|P2|Participant Flow|Sequence 2|Prototype disinfectant spray was sprayed twice on first wound, followed by Negative control sprayed twice on the second wound and subsequently Reference product was sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.
76307|NCT02106403|P1|Participant Flow|Sequence 1|Prototype disinfectant spray was sprayed twice on first wound, followed by Reference product twice sprayed on the second wound and subsequently Negative control was sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.
76308|NCT02106403|O3|Outcome|Negative Control|0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
76309|NCT02106403|O2|Outcome|Reference Product|0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
76310|NCT02106403|O1|Outcome|Prototype Disinfectant Spray Formulation|0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
76311|NCT02106403|O3|Outcome|Negative Control|0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
76312|NCT02106403|O2|Outcome|Reference Product|0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
76451|NCT02105948|B5|Baseline|Total|Total of all reporting groups
76314|NCT02106403|O3|Outcome|Negative Control|0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
76315|NCT02106403|O2|Outcome|Reference Product|0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
76316|NCT02106403|O1|Outcome|Prototype Disinfectant Spray Formulation|0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound
76317|NCT02106403|O3|Outcome|Negative Control|0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
76318|NCT02106403|O2|Outcome|Reference Product|0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
76319|NCT02106403|O1|Outcome|Prototype Disinfectant Spray Formulation|0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
76320|NCT02106403|O3|Outcome|Negative Control|0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
76321|NCT02106403|O2|Outcome|Reference Product|0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
76322|NCT02106403|O1|Outcome|Prototype Disinfectant Spray Formulation|0.13% w/w Benzalkonium Chloride (BAC) and 1% Menthone Glycerin Acetal (MGA). After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
76323|NCT02106403|E3|Reported Event|Negative Control|0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
76324|NCT02106403|E2|Reported Event|Reference Product|0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
76325|NCT02106403|E1|Reported Event|Prototype Disinfectant Spray Formulation|0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
76326|NCT02106156|B4|Baseline|Total|Total of all reporting groups
76327|NCT02106156|B3|Baseline|Elastography Analysis Set: Untreated|The untreated elastography analysis set includes those participants with CHC, who underwent elastography, were documented in the fibroscan module and were not treated with HCV treatment.
76328|NCT02106156|B2|Baseline|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
76329|NCT02106156|B1|Baseline|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
76330|NCT02106156|P3|Participant Flow|Elastography Analysis Set: Untreated|The untreated elastography analysis set includes those participants with CHC, who underwent elastography, were documented in the fibroscan module and were not treated with HCV treatment.
76331|NCT02106156|P2|Participant Flow|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with hepatitis C virus (HCV) treatment as indicated.
76332|NCT02106156|P1|Participant Flow|Main Analysis Set|Participants with chronic hepatitis C (CHC) treated with pegylated interferon (peginterferon) alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding summary of product characteristics (SmPC).
76333|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
76334|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
76335|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
76336|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
76337|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
76338|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
76339|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
76515|NCT02105701|O1|Outcome|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
76340|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
76341|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
76342|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
76343|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
76344|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
76345|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
76346|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
76347|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
76348|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
76349|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
76350|NCT02106156|E3|Reported Event|Elastography Analysis Set: Untreated|Participants with CHC in the untreated elastography analysis set includes those participants, who underwent elastography, were documented in the fibroscan module and were not treated with HCV treatment.
76351|NCT02106156|E2|Reported Event|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those, who were treated with HCV treatment as indicated.
76352|NCT02106156|E1|Reported Event|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
76353|NCT02105987|B3|Baseline|Total|Total of all reporting groups
76354|NCT02105987|B2|Baseline|Late Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76355|NCT02105987|B1|Baseline|Early Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
76356|NCT02105987|P6|Participant Flow|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Late Switch:Cont Phase|If ABC/DTG/3TC was not locally approved and commercially available when a participant successfully completed the Week 48 visit, the participant had the opportunity to enter into the Continuation Phase. During the Continuation Phase, participants were supplied with ABC/DTG/3TC until it was locally approved and commercially available.
76357|NCT02105987|P5|Participant Flow|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Early Switch:Cont Phase|If ABC/DTG/3TC was not locally approved and commercially available when a participant successfully completed the Week 48 visit, the participant had the opportunity to enter into the Continuation Phase. During the Continuation Phase, participants were supplied with ABC/DTG/3TC until it was locally approved and commercially available.
76358|NCT02105987|P4|Participant Flow|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Late Switch|Participants who completed early switch phase and maintained viral suppression (<50 Copies per milliliter [c/mL]) were switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76359|NCT02105987|P3|Participant Flow|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Early Switch|Participants who completed early switch phase continued to receive ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for an additional 24 weeks.
76360|NCT02105987|P2|Participant Flow|Current ART|Participants continued on their current ART regimen for 24 weeks.
76361|NCT02105987|P1|Participant Flow|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received abacavir (ABC) 600 milligrams (mg)/ dolutegravir (DTG) 50 mg/ lamivudine (3TC) 300 mg fixed-dose combination (FDC) tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks.
76362|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76363|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
76364|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76365|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
76366|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76367|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
76368|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76369|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
76370|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76371|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
76372|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76373|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
76374|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76375|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
76376|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76377|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
76378|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76379|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
76380|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76381|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
76382|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76383|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
76512|NCT02105701|O4|Outcome|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
76384|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76385|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
76386|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76387|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
76388|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76389|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
76390|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76391|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
76392|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76393|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
76394|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76395|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
76396|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76397|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
76398|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76399|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
76400|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76401|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
76402|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76403|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
76404|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76405|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
76513|NCT02105701|O3|Outcome|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
76668|NCT02105285|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
76406|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76407|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
76408|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76409|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
76410|NCT02105987|E2|Reported Event|Late Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
76411|NCT02105987|E1|Reported Event|Early Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
76412|NCT02105974|B3|Baseline|Total|Total of all reporting groups
76413|NCT02105974|B2|Baseline|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
76414|NCT02105974|B1|Baseline|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
76415|NCT02105974|P3|Participant Flow|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler [MDI] or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
76416|NCT02105974|P2|Participant Flow|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler [MDI] or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
76417|NCT02105974|P1|Participant Flow|Placebo Run-In|Participants received placebo once daily (QD) in the morning for 2 weeks. In addition, participants were provided an inhaled short-acting beta2-receptor agonist (SABA), albuterol (salbutamol) (metered dose inhaler [MDI] or nebules), to be used as a rescue medication for relief of chronic obstructive pulmonary disease (COPD) symptoms during the Run-in and Treatment Periods.
76418|NCT02105974|O2|Outcome|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
76419|NCT02105974|O1|Outcome|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
76420|NCT02105974|O2|Outcome|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
76421|NCT02105974|O1|Outcome|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
76422|NCT02105974|O2|Outcome|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
76423|NCT02105974|O1|Outcome|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
76424|NCT02105974|E2|Reported Event|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
76669|NCT02105285|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
76425|NCT02105974|E1|Reported Event|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
76426|NCT02105961|B4|Baseline|Total|Total of all reporting groups
76427|NCT02105961|B3|Baseline|Mepolizumab 300 mg SC|Eligible participants were randomized to and received mepolizumab 300 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76428|NCT02105961|B2|Baseline|Mepolizumab 100 mg SC|Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76429|NCT02105961|B1|Baseline|Placebo|Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76430|NCT02105961|P3|Participant Flow|Mepolizumab 300 mg SC|Eligible participants were randomized to and received mepolizumab 300 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76431|NCT02105961|P2|Participant Flow|Mepolizumab 100 mg SC|Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76432|NCT02105961|P1|Participant Flow|Placebo|Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their standard of care (SoC) therapy. Salbutamol metered dose inhaler (MDI) was issued for use as rescue medication throughout the study.
76433|NCT02105961|O3|Outcome|Mepolizumab 300 mg SC|Eligible participants were randomized to and received mepolizumab 300 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76434|NCT02105961|O2|Outcome|Mepolizumab 100 mg SC|Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76435|NCT02105961|O1|Outcome|Placebo|Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76436|NCT02105961|O3|Outcome|Mepolizumab 300 mg SC|Eligible participants were randomized to and received mepolizumab 300 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76437|NCT02105961|O2|Outcome|Mepolizumab 100 mg SC|Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76438|NCT02105961|O1|Outcome|Placebo|Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76439|NCT02105961|O3|Outcome|Mepolizumab 300 mg SC|Eligible participants were randomized to and received mepolizumab 300 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76440|NCT02105961|O2|Outcome|Mepolizumab 100 mg SC|Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76441|NCT02105961|O1|Outcome|Placebo|Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76442|NCT02105961|O3|Outcome|Mepolizumab 300 mg SC|Eligible participants were randomized to and received mepolizumab 300 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76443|NCT02105961|O2|Outcome|Mepolizumab 100 mg SC|Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76444|NCT02105961|O1|Outcome|Placebo|Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76445|NCT02105961|O3|Outcome|Mepolizumab 300 mg SC|Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76446|NCT02105961|O2|Outcome|Mepolizumab 100 mg SC|Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76447|NCT02105961|O1|Outcome|Placebo|Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76448|NCT02105961|E3|Reported Event|Mepolizumab 300 mg SC|Eligible participants were randomized to and received mepolizumab 300 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76449|NCT02105961|E2|Reported Event|Mepolizumab 100 mg SC|Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76450|NCT02105961|E1|Reported Event|Placebo|Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76452|NCT02105948|B4|Baseline|Mepolizumab 100 mg - Low Stratum|Participants with blood eosinophil counts <150 cells/µL at Screening and no evidence of blood eosinophil counts >=300 cells/µL in the 12 months prior were assigned to the low stratum group. These participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76453|NCT02105948|B3|Baseline|Placebo - Low Stratum|Participants with blood eosinophil counts <150 cells/µL at Screening and no evidence of blood eosinophil counts >=300 cells/µL in the 12 months prior were assigned to the low stratum group. These participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76454|NCT02105948|B2|Baseline|Mepolizumab 100 mg - High Stratum|Participants with blood eosinophil counts >=150 cells/µL at Screening or >=300 cells/ µL in the 12 months prior were assigned to the high stratum group. These participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76455|NCT02105948|B1|Baseline|Placebo - High Stratum|Participants with blood eosinophil counts >=150 cells/µL at Screening or >=300 cells/µL in the 12 months prior were assigned to the high stratum group. These participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76456|NCT02105948|P4|Participant Flow|Mepolizumab 100 mg - Low Stratum|Participants with blood eosinophil counts <150 cells/µL at Screening and no evidence of blood eosinophil counts >=300 cells/µL in the 12 months prior were assigned to the low stratum group. These participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76457|NCT02105948|P3|Participant Flow|Placebo - Low Stratum|Participants with blood eosinophil counts <150 cells/µL at Screening and no evidence of blood eosinophil counts >=300 cells/µL in the 12 months prior were assigned to the low stratum group. These participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76458|NCT02105948|P2|Participant Flow|Mepolizumab 100 mg - High Stratum|Participants with blood eosinophil counts >=150 cells/µL at Screening or >=300 cells/ µL in the 12 months prior were assigned to the high stratum group. These participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76459|NCT02105948|P1|Participant Flow|Placebo - High Stratum|Participants with blood eosinophil counts >=150 cells per microliter (cells/µL) at Screening or >=300 cells/µL in the 12 months prior were assigned to the high stratum group. These participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their standard of care (SoC) therapy. Salbutamol metered dose inhaler (MDI) was issued for use as rescue medication throughout the study.
76460|NCT02105948|O2|Outcome|Mepolizumab 100 mg|Participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76461|NCT02105948|O1|Outcome|Placebo|Participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76462|NCT02105948|O2|Outcome|Mepolizumab 100 mg|Participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76463|NCT02105948|O1|Outcome|Placebo|Participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76464|NCT02105948|O2|Outcome|Mepolizumab 100 mg|Participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76465|NCT02105948|O1|Outcome|Placebo|Participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76466|NCT02105948|O2|Outcome|Mepolizumab 100 mg|Participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76467|NCT02105948|O1|Outcome|Placebo|Participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76468|NCT02105948|O2|Outcome|Mepolizumab 100 mg - High Stratum|Participants with blood eosinophil counts >=150 cells/µL at Screening or >=300 cells/ µL in the 12 months prior were assigned to the high stratum group. These participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76469|NCT02105948|O1|Outcome|Placebo - High Stratum|Participants with blood eosinophil counts >=150 cells/µL at Screening or >=300 cells/µL in the 12 months prior were assigned to the high stratum group. These participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76470|NCT02105948|O2|Outcome|Mepolizumab 100 mg - High Stratum|Participants with blood eosinophil counts >=150 cells/µL at Screening or >=300 cells/ µL in the 12 months prior were assigned to the high stratum group. These participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76514|NCT02105701|O2|Outcome|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
76471|NCT02105948|O1|Outcome|Placebo - High Stratum|Participants with blood eosinophil counts >=150 cells/µL at Screening or >=300 cells/µL in the 12 months prior were assigned to the high stratum group. These participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76472|NCT02105948|O2|Outcome|Mepolizumab 100 mg - High Stratum|Participants with blood eosinophil counts >=150 cells/µL at Screening or >=300 cells/ µL in the 12 months prior were assigned to the high stratum group. These participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76473|NCT02105948|O1|Outcome|Placebo - High Stratum|Participants with blood eosinophil counts >=150 cells/µL at Screening or >=300 cells/µL in the 12 months prior were assigned to the high stratum group. These participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76474|NCT02105948|O2|Outcome|Mepolizumab 100 mg - High Stratum|Participants with blood eosinophil counts >=150 cells/µL at Screening or >=300 cells/ µL in the 12 months prior were assigned to the high stratum group. These participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76475|NCT02105948|O1|Outcome|Placebo - High Stratum|Participants with blood eosinophil counts >=150 cells/µL at Screening or >=300 cells/µL in the 12 months prior were assigned to the high stratum group. These participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76476|NCT02105948|O2|Outcome|Mepolizumab 100 mg|Participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76477|NCT02105948|O1|Outcome|Placebo|Participants were randomized to and received Placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76478|NCT02105948|O2|Outcome|Mepolizumab 100 mg - High Stratum|Participants with blood eosinophil counts >=150 cells/µL at Screening or >=300 cells/ µL in the 12 months prior were assigned to the high stratum group. These participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76479|NCT02105948|O1|Outcome|Placebo - High Stratum|Participants with blood eosinophil counts >=150 cells/µL at Screening or >=300 cells/µL in the 12 months prior were assigned to the high stratum group. These participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76480|NCT02105948|E4|Reported Event|Mepolizumab 100 mg - Low Stratum|Participants with blood eosinophil counts <150 cells/µL at Screening and no evidence of blood eosinophil counts >=300 cells/µL in the 12 months prior were assigned to the low stratum group. These participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76481|NCT02105948|E3|Reported Event|Placebo - Low Stratum|Participants with blood eosinophil counts <150 cells/µL at Screening and no evidence of blood eosinophil counts >=300 cells/µL in the 12 months prior were assigned to the low stratum group. These participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76482|NCT02105948|E2|Reported Event|Mepolizumab 100 mg - High Stratum|Participants with blood eosinophil counts >=150 cells/µL at Screening or >=300 cells/ µL in the 12 months prior were assigned to the high stratum group. These participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76483|NCT02105948|E1|Reported Event|Placebo - High Stratum|Participants with blood eosinophil counts >=150 cells/µL at Screening or >=300 cells/µL in the 12 months prior were assigned to the high stratum group. These participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
76484|NCT02105740|B3|Baseline|Total|Total of all reporting groups
76485|NCT02105740|B2|Baseline|Control|"Comparison of the effects of hypnosis between the control group and the experimental group regarding pain, anxiety and depression with the application of the scales.~Control : The control and experimental groups respond in 3 different moments to Visual Analog Scale (VAS) for the evaluation of pain, and to Hospital Anxiety and Depression Scale (HADS) to evaluate depression and the anxiety. The first meeting was made before the hypnosis. In the second meeting, within an interval of 7 days, the scales were applied in all patients. Before applying the scales, the hypnosis group was submitted to the session. The third meeting occurred two weeks later, where the scales were only applied to compare the groups."
76486|NCT02105740|B1|Baseline|Hypnosis|"Use of hypnosis to reduct the levels of pain, depression and anxiety.~Hypnosis: The hypnosis intervention consists of two sessions of 40-minute, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression of the same."
76487|NCT02105740|P2|Participant Flow|Control|"Comparison of the effects of hypnosis between the control group and the hypnosis group regarding pain, anxiety and depression with the application of the scales.~Control x Hypnosis Group: The control and hypnosis groups respond in 3 different distinct moments, with the Visual Analogue Scale (VAS) for the evaluation of pain, and the Hospital Anxiety and Depression Scale (HADS) to evaluate the depression and the anxiety. The first evaluation will be made before the research. The second within an interval of 7 days, so being that in the experimental group the same will happen after the hypnosis session and in the control group, after the follow-up visit. The third evaluation will occur two weeks later, in order to provide a follow-up to assess the efficacy of the technique. The experimental group and the control group will be compared in relation to the intensity of the pain, depression and anxiety."
76488|NCT02105740|P1|Participant Flow|Hypnosis|"Use of hypnosis in the reduction of the levels of pain, depression and anxiety.~Hypnosis: The hypnosis intervention consists of two sessions of 40-minute, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression."
76489|NCT02105740|O2|Outcome|Control|"Comparison of the effects of hypnosis between the control group and the experimental group regarding anxiety and depression with the application of the Hospital Anxiety and Depression Scale (HADS).~Control x Experimental Group: The control and experimental groups respond in 3 different distinct moments, with the Hospital Anxiety and Depression Scale (HADS) to evaluate depression and anxiety. The first evaluation was made before the research. The second within an interval of 7 days, so being that in the experimental group the same will happen after the hypnosis session and in the control group after the follow-up visit. The third evaluation was two weeks later, in order to provide a follow-up to assess the efficacy of the technique. The experimental group and the control group was compared in relation to the intensity of the depression and anxiety"
76490|NCT02105740|O1|Outcome|Hypnosis|"Use of hypnosis in the reduction of the levels depression and anxiety.~Hypnosis: The hypnosis intervention consists of two 40-minute sessions, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression of the same."
76491|NCT02105740|O2|Outcome|Control|"Comparison of the effects of hypnosis between the control group and the hypnosis group regarding pain with the application of the Visual Analogue Scale (VAS).~Control x Hypnosis Group: The control and the hypnosis groups respond in 3 different distinct moments, using the Visual Analogue Scale (VAS) to evaluate the pain. The first evaluation was made before the research. The second within an interval of 7 days, so being that in the experimental group the same will happen after the hypnosis session and in the control group after the follow-up visit. The third evaluation was made two weeks later, in order to provide a follow-up to assess the efficacy of the technique."
76492|NCT02105740|O1|Outcome|Hypnosis|"Use of hypnosis to change the levels of pain.~Hypnosis: The hypnosis intervention consists of two 40-minute sessions, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms."
76493|NCT02105740|E2|Reported Event|Control|"Comparison of the effects of hypnosis between the control group and the experimental group regarding pain, anxiety and depression with the application of the scales.~Control x Experimental Group: The control and experimental groups respond in 3 different distinct moments, with the Visual Analog Scale (VAS) for the evaluation of pain, and the Hospital Anxiety and Depression Scale (HADS) to evaluate the depression and the anxiety. The first evaluation will be made before the research. The second within an interval of 7 days, so being that in the experimental group the same will happen after the hypnosis session and in the control group after the follow-up visit. The third evaluation will be two weeks later, in order to provide a follow-up to assess the efficacy of the technique. The experimental group and the control group will be compared in relation to the intensity of the pain, depression and anxiety"
76494|NCT02105740|E1|Reported Event|Hypnosis|"Use of hypnosis in the reduction of the levels of pain, depression and anxiety.~Hypnosis: The hypnosis intervention consists of two 40-minute sessions, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression of the same."
76495|NCT02105701|B5|Baseline|Total|Total of all reporting groups
76496|NCT02105701|B4|Baseline|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
76497|NCT02105701|B3|Baseline|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
76498|NCT02105701|B2|Baseline|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
76499|NCT02105701|B1|Baseline|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
76500|NCT02105701|P4|Participant Flow|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
76501|NCT02105701|P3|Participant Flow|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
76502|NCT02105701|P2|Participant Flow|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
76503|NCT02105701|P1|Participant Flow|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
76504|NCT02105701|O4|Outcome|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
76505|NCT02105701|O3|Outcome|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
76506|NCT02105701|O2|Outcome|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
76507|NCT02105701|O1|Outcome|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
76508|NCT02105701|O4|Outcome|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
76509|NCT02105701|O3|Outcome|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
76510|NCT02105701|O2|Outcome|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
76511|NCT02105701|O1|Outcome|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
76516|NCT02105701|O4|Outcome|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
76517|NCT02105701|O3|Outcome|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
76518|NCT02105701|O2|Outcome|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
76519|NCT02105701|O1|Outcome|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
76520|NCT02105701|E4|Reported Event|GZR/EBR + RBV for 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
76521|NCT02105701|E3|Reported Event|GZR/EBR 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
76522|NCT02105701|E2|Reported Event|GZR/EBR + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
76523|NCT02105701|E1|Reported Event|GZR/EBR 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
76524|NCT02105688|B3|Baseline|Total|Total of all reporting groups
76525|NCT02105688|B2|Baseline|Deferred Treatment Arm|In Part A, participants receive placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants receive 12 weeks of open-label treatment with the MK-5172A FDC and are followed-up for 24 weeks.
76526|NCT02105688|B1|Baseline|Immediate Treatment Arm|In Part A, participants receive grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and are followed-up for 24 weeks.
76527|NCT02105688|P2|Participant Flow|Deferred Treatment Arm|In Part A, participants receive placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants receive 12 weeks of open-label treatment with the MK-5172A FDC and are followed-up for 24 weeks.
76528|NCT02105688|P1|Participant Flow|Immediate Treatment Arm|In Part A, participants receive grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and are followed-up for 24 weeks.
76529|NCT02105688|O2|Outcome|Deferred Treatment Arm|In Part A, participants receive placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants receive 12 weeks of open-label treatment with the MK-5172A FDC and are followed-up for 24 weeks.
76530|NCT02105688|O1|Outcome|Immediate Treatment Arm|In Part A, participants receive grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and are followed-up for 24 weeks.
76531|NCT02105688|O2|Outcome|Deferred Treatment Arm|In Part A, participants receive placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants receive 12 weeks of open-label treatment with the MK-5172A FDC and are followed-up for 24 weeks.
76532|NCT02105688|O1|Outcome|Immediate Treatment Arm|In Part A, participants receive grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and are followed-up for 24 weeks.
76533|NCT02105688|O2|Outcome|Deferred Treatment Arm|In Part A, participants receive placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants receive 12 weeks of open-label treatment with the MK-5172A FDC and are followed-up for 24 weeks.
76534|NCT02105688|O1|Outcome|Immediate Treatment Arm|In Part A, participants receive grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and are followed-up for 24 weeks.
76535|NCT02105688|E2|Reported Event|Deferred Treatment Arm (Placebo)|In Part A, participants receive placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up.
76536|NCT02105688|E1|Reported Event|Immediate Treatment Arm|In Part A, participants receive grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and are followed-up for 24 weeks.
76537|NCT02105662|B1|Baseline|Grazoprevir+Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
76538|NCT02105662|P1|Participant Flow|Grazoprevir+Elbasvir|Participants received a fixed-dose combination (FDC) of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
76539|NCT02105662|O1|Outcome|Grazoprevir+Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
76540|NCT02105662|O1|Outcome|Grazoprevir+Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
76541|NCT02105662|O1|Outcome|Grazoprevir+Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
76542|NCT02105662|O1|Outcome|Grazoprevir+Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
76543|NCT02105662|E1|Reported Event|Grazoprevir + Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
76544|NCT02105636|B3|Baseline|Total|Total of all reporting groups
76545|NCT02105636|B2|Baseline|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice.
76546|NCT02105636|B1|Baseline|Nivolumab 3mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
76670|NCT02105285|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
76547|NCT02105636|P2|Participant Flow|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice.
76548|NCT02105636|P1|Participant Flow|Nivolumab 3mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
76549|NCT02105636|O2|Outcome|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigator's Choice.
76550|NCT02105636|O1|Outcome|Nivolumab 3mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
76551|NCT02105636|O2|Outcome|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice.
76552|NCT02105636|O1|Outcome|Nivolumab 3mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
76553|NCT02105636|O2|Outcome|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice.
76554|NCT02105636|O1|Outcome|Nivolumab 3mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
76555|NCT02105636|E2|Reported Event|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice.
76556|NCT02105636|E1|Reported Event|Nivolumab 3 mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
76557|NCT02105467|B3|Baseline|Total|Total of all reporting groups
76558|NCT02105467|B2|Baseline|Deferred Treatment Group|Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks.
76559|NCT02105467|B1|Baseline|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
76560|NCT02105467|P2|Participant Flow|Deferred Treatment Group|Participants received blinded placebo tablet orally once daily for 12 weeks (Period 1), followed by a 4-week unblinding/washout period and 12 weeks of open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily (Period 2), followed by a 24-week follow-up period (Period 3).
76561|NCT02105467|P1|Participant Flow|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks (Period 1), followed by a 24-week follow-up period (Period 2)
76562|NCT02105467|O1|Outcome|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
76563|NCT02105467|O1|Outcome|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
76564|NCT02105467|O2|Outcome|Deferred Treatment Group|Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks.
76565|NCT02105467|O1|Outcome|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
76566|NCT02105467|O2|Outcome|Deferred Treatment Group|Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks.
76567|NCT02105467|O1|Outcome|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
76568|NCT02105467|O1|Outcome|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
76569|NCT02105467|E3|Reported Event|Deferred Treatment Group (Open-label Treatment)|Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks. Adverse event reporting covers Week 16 through Week 52.
76570|NCT02105467|E2|Reported Event|Deferred Treatment Group (Blinded Treatment)|Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks. Adverse event reporting covers Day 1 through Week 16.
76571|NCT02105467|E1|Reported Event|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period. Adverse event reporting covers Day 1 through Week 36.
76572|NCT02105454|B1|Baseline|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
76573|NCT02105454|P1|Participant Flow|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
76574|NCT02105454|O1|Outcome|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
76575|NCT02105454|O1|Outcome|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
76576|NCT02105454|O1|Outcome|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
76577|NCT02105454|O1|Outcome|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
76578|NCT02105454|E1|Reported Event|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
76579|NCT02105324|B1|Baseline|All Randomized Participants|All randomized participants who completed both periods of the study.
76580|NCT02105324|P2|Participant Flow|Usual Care Then Bionic Pancreas|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days in Period 1, followed by Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a CGM device, for 5 days in Period 2. There was a 3-day washout period between periods.
76581|NCT02105324|P1|Participant Flow|Bionic Pancreas Then Usual Care|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days in Period 1, followed by Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days in Period 2. There was a 3-day washout period between periods.
76582|NCT02105324|O1|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76583|NCT02105324|O1|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76584|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76585|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76586|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76587|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76588|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76589|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76671|NCT02105285|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
76672|NCT02105285|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
76590|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76591|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76592|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76593|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76594|NCT02105324|O1|Outcome|Bionic Pancreas|management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76595|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76596|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76597|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76598|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76599|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76600|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76601|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76602|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76603|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76604|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76605|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76606|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76607|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76608|NCT02105324|O1|Outcome|Bionic Pancreas|Participants who were randomized and began in the trial
76609|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76610|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76611|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76612|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76613|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76614|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76615|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76616|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76617|NCT02105324|O1|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76618|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76619|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76620|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76621|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76622|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76623|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76624|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76625|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76626|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76627|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76628|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76629|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76630|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76631|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76632|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76633|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76634|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76635|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76636|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76637|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76638|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76639|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76640|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76641|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76642|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76643|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76644|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76645|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76646|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76647|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76648|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76649|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76650|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76651|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76652|NCT02105324|O2|Outcome|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76653|NCT02105324|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76654|NCT02105324|E2|Reported Event|Usual Care|Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
76655|NCT02105324|E1|Reported Event|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
76656|NCT02105285|B4|Baseline|Total|Total of all reporting groups
76657|NCT02105285|B3|Baseline|Carteolol and Latanoprost Ophthalmic Solution|"Once daily~Carteolol ophthalmic solution and Latanoprost ophthalmic solution"
76658|NCT02105285|B2|Baseline|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
76659|NCT02105285|B1|Baseline|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
76660|NCT02105285|P3|Participant Flow|Carteolol and Latanoprost Ophthalmic Solution|"Once daily~Carteolol ophthalmic solution and Latanoprost ophthalmic solution"
76661|NCT02105285|P2|Participant Flow|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
76662|NCT02105285|P1|Participant Flow|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
76663|NCT02105285|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
76664|NCT02105285|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
76665|NCT02105285|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
76666|NCT02105285|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
76667|NCT02105285|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
76675|NCT02105285|E3|Reported Event|Carteolol and Latanoprost Ophthalmic Solution|"Once daily~Carteolol ophthalmic solution and Latanoprost ophthalmic solution"
76676|NCT02105285|E2|Reported Event|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
76677|NCT02105285|E1|Reported Event|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
76678|NCT02105272|B3|Baseline|Total|Total of all reporting groups
76679|NCT02105272|B2|Baseline|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
76680|NCT02105272|B1|Baseline|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
76681|NCT02105272|P2|Participant Flow|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
76682|NCT02105272|P1|Participant Flow|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
76683|NCT02105272|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
76684|NCT02105272|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
76685|NCT02105272|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
76686|NCT02105272|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
76687|NCT02105272|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
76688|NCT02105272|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
76689|NCT02105272|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
76690|NCT02105272|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
76691|NCT02105272|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
76692|NCT02105272|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
76693|NCT02105272|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
76694|NCT02105272|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
76695|NCT02105272|E2|Reported Event|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
76696|NCT02105272|E1|Reported Event|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
76697|NCT02105012|B1|Baseline|All Subjects|
76698|NCT02105012|P1|Participant Flow|All Subjects|
76699|NCT02105012|O5|Outcome|Placebo MDI|Placebo MDI.
76700|NCT02105012|O4|Outcome|BD MDI 40 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
76701|NCT02105012|O3|Outcome|BD MDI 80 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
76702|NCT02105012|O2|Outcome|BD MDI 160 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
76703|NCT02105012|O1|Outcome|BD MDI 320 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
76704|NCT02105012|O5|Outcome|Placebo MDI|Placebo MDI.
76705|NCT02105012|O4|Outcome|BD MDI 40 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
76706|NCT02105012|O3|Outcome|BD MDI 80 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
76707|NCT02105012|O2|Outcome|BD MDI 160 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
76708|NCT02105012|O1|Outcome|BD MDI 320 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
76709|NCT02105012|O5|Outcome|Placebo MDI|Placebo MDI.
76710|NCT02105012|O4|Outcome|BD MDI 40 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
76711|NCT02105012|O3|Outcome|BD MDI 80 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
76712|NCT02105012|O2|Outcome|BD MDI 160 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
76713|NCT02105012|O1|Outcome|BD MDI 320 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
76714|NCT02105012|O5|Outcome|Placebo MDI|Placebo MDI.
76715|NCT02105012|O4|Outcome|BD MDI 40 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
76716|NCT02105012|O3|Outcome|BD MDI 80 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
76717|NCT02105012|O2|Outcome|BD MDI 160 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
76718|NCT02105012|O1|Outcome|BD MDI 320 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
76719|NCT02105012|O5|Outcome|Placebo MDI|Placebo MDI.
76720|NCT02105012|O4|Outcome|BD MDI 40 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
76721|NCT02105012|O3|Outcome|BD MDI 80 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
76722|NCT02105012|O2|Outcome|BD MDI 160 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
76723|NCT02105012|O1|Outcome|BD MDI 320 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
76724|NCT02105012|E5|Reported Event|Placebo MDI|Placebo MDI.
76725|NCT02105012|E4|Reported Event|BD MDI 40 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
76726|NCT02105012|E3|Reported Event|BD MDI 80 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
76727|NCT02105012|E2|Reported Event|BD MDI 160 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
76728|NCT02105012|E1|Reported Event|BD MDI 320 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
76729|NCT02104947|B3|Baseline|Total|Total of all reporting groups
76730|NCT02104947|B2|Baseline|Idarucizumab (Group B)|Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
76731|NCT02104947|B1|Baseline|Idarucizumab (Group A)|Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
76792|NCT02104804|P2|Participant Flow|Vs. Placebo Plus Insulin|Patients receiving placebo 5 mg plus insulin
76793|NCT02104804|P1|Participant Flow|Saxagliptin Plus Insulin|Saxagliptin 5 mg plus insulin
76732|NCT02104947|P2|Participant Flow|Idarucizumab (Group B)|Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
76733|NCT02104947|P1|Participant Flow|Idarucizumab (Group A)|Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
76734|NCT02104947|O2|Outcome|Idarucizumab (Group B)|Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
76735|NCT02104947|O1|Outcome|Idarucizumab (Group A)|Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
76736|NCT02104947|O1|Outcome|Idarucizumab (Group A & B)|"In Group A the patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.~In Group B the patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes."
76737|NCT02104947|O2|Outcome|Non-ICH (Group A)|Group A patients with baseline non-intracranial hemorrhage (non-ICH).
76738|NCT02104947|O1|Outcome|ICH (Group A)|Group A patients with baseline intracranial hemorrhage (ICH).
76739|NCT02104947|O1|Outcome|Idarucizumab (Group B)|Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
76740|NCT02104947|O2|Outcome|Idarucizumab (Group B)|Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
76741|NCT02104947|O1|Outcome|Idarucizumab (Group A)|Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
76742|NCT02104947|O2|Outcome|Idarucizumab (Group B)|Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
76743|NCT02104947|O1|Outcome|Idarucizumab (Group A)|Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
76744|NCT02104947|O2|Outcome|Idarucizumab (Group B)|Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
76745|NCT02104947|O1|Outcome|Idarucizumab (Group A)|Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
76746|NCT02104947|E2|Reported Event|Idarucizumab (Group B)|Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
76794|NCT02104804|O2|Outcome|Vs. Placebo Plus Insulin|Patients receiving placebo 5 mg plus insulin
76795|NCT02104804|O1|Outcome|Saxagliptin Plus Insulin|Saxagliptin 5 mg plus insulin
76747|NCT02104947|E1|Reported Event|Idarucizumab (Group A)|Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
76748|NCT02104895|B3|Baseline|Total|Total of all reporting groups
76749|NCT02104895|B2|Baseline|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)~Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
76750|NCT02104895|B1|Baseline|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)~Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
76751|NCT02104895|P2|Participant Flow|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)~Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
76752|NCT02104895|P1|Participant Flow|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)~Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
76753|NCT02104895|O2|Outcome|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)~Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
76754|NCT02104895|O1|Outcome|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)~Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
76755|NCT02104895|O2|Outcome|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)~Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
76756|NCT02104895|O1|Outcome|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)~Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
76757|NCT02104895|O2|Outcome|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)~Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
76758|NCT02104895|O1|Outcome|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)~Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
76759|NCT02104895|E2|Reported Event|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)~Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
76760|NCT02104895|E1|Reported Event|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)~Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
76761|NCT02104830|B4|Baseline|Total|Total of all reporting groups
76762|NCT02104830|B3|Baseline|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy and placebo #1 in dose 1.0 ml ubcutaneously, 24 h after the chemotherapy.~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
76763|NCT02104830|B2|Baseline|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.~empegfilrastim 7.5 mg: Empegfilgrastim is supplied as solution for injection 3 mg/ml.~Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg."
76764|NCT02104830|B1|Baseline|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days~empegfilrastim 6 mg: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg.~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
76765|NCT02104830|P3|Participant Flow|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
76766|NCT02104830|P2|Participant Flow|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
76767|NCT02104830|P1|Participant Flow|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
76768|NCT02104830|O3|Outcome|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
76769|NCT02104830|O2|Outcome|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
76796|NCT02104804|O2|Outcome|Vs. Placebo Plus Insulin|Patients receiving placebo 5 mg plus insulin
76770|NCT02104830|O1|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
76771|NCT02104830|O3|Outcome|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
76772|NCT02104830|O2|Outcome|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
76773|NCT02104830|O1|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
76774|NCT02104830|O3|Outcome|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
76775|NCT02104830|O2|Outcome|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
76776|NCT02104830|O1|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
76777|NCT02104830|O3|Outcome|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
76778|NCT02104830|O2|Outcome|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
76779|NCT02104830|O1|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
76780|NCT02104830|O3|Outcome|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
76781|NCT02104830|O2|Outcome|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
76782|NCT02104830|O1|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
76783|NCT02104830|O3|Outcome|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
76784|NCT02104830|O2|Outcome|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
76785|NCT02104830|O1|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
76786|NCT02104830|E3|Reported Event|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
76787|NCT02104830|E2|Reported Event|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
76788|NCT02104830|E1|Reported Event|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
76789|NCT02104804|B3|Baseline|Total|Total of all reporting groups
76790|NCT02104804|B2|Baseline|Vs. Placebo Plus Insulin|Patients receiving placebo 5 mg plus insulin
76791|NCT02104804|B1|Baseline|Saxagliptin Plus Insulin|Saxagliptin 5 mg plus insulin
76809|NCT02104505|B2|Baseline|Placebo (14 Days) Then Gamma Tocopherol (14 Days)|Safflower oil capsules x 14 days, washout for minimum 3 weeks, then Gamma Tocopherol (2 capsules, each containing 700 mg, daily) x 14 days
76810|NCT02104505|B1|Baseline|Gamma Tocopherol (14 Days) Then Placebo (14 Days)|Gamma Tocopherol (2 capsules, each containing 700 mg, daily) x 14 days, washout for minimum 3 weeks, then Safflower oil capsules x 14 days
76811|NCT02104505|P2|Participant Flow|Placebo (14 Days) Then Gamma Tocopherol (14 Days)|Safflower oil capsules x 14 days, washout for minimum 3 weeks, then Gamma Tocopherol (2 capsules, each containing 700 mg, daily) x 14 days
76812|NCT02104505|P1|Participant Flow|Gamma Tocopherol (14 Days) Then Placebo (14 Days)|Gamma Tocopherol (2 capsules, each containing 700 mg, daily) x 14 days, washout for minimum 3 weeks, then Safflower oil capsules x 14 days
76813|NCT02104505|O2|Outcome|Placebo|700 mg Safflower oil capsules; 2 capsules daily for 14 days
76814|NCT02104505|O1|Outcome|Gamma Tocopherol|Gamma Tocopherol 700 mg capsules,: 2 capsules daily for 14 days
76815|NCT02104505|O2|Outcome|Placebo|700 mg Safflower oil capsules; 2 capsules daily for 14 days
76816|NCT02104505|O1|Outcome|Gamma Tocopherol|Gamma Tocopherol 700 mg capsules: 2 capsules daily for 14 days
76817|NCT02104505|O2|Outcome|Placebo|700 mg Safflower oil capsules; 2 capsules daily for 14 days
76818|NCT02104505|O1|Outcome|Gamma Tocopherol|Gamma Tocopherol 700 mg capsules,: 2 capsules daily for 14 days
76819|NCT02104505|O2|Outcome|Placebo|700 mg Safflower oil capsules; 2 capsules daily for 14 days
76820|NCT02104505|O1|Outcome|Gamma Tocopherol|Gamma Tocopherol 700 mg capsules,: 2 capsules daily for 14 days
76821|NCT02104505|E2|Reported Event|Placebo|700 mg Safflower oil capsules; 2 capsules daily for 14 days
76822|NCT02104505|E1|Reported Event|Gamma Tocopherol|Gamma Tocopherol 700 mg capsules; 2 capsules daily for 14 days
76823|NCT02104427|B1|Baseline|TG-0054 Combined With G-CSF|1. G-CSF: 10 μg/kg/day, administrated via SC injections from Day 1 to Day 8; 2. TG-0054: 3.14 mg/kg, administrated via 15-min IV infusion from Day 5 to Day 9 as needed to reach the target collection goal.
76824|NCT02104427|P1|Participant Flow|TG-0054 Combined With G-CSF|1. G-CSF: 10 μg/kg/day, administrated via SC injections from Day 1 to Day 8; 2. TG-0054: 3.14 mg/kg, administrated via 15-min IV infusion from Day 5 to Day 9 as needed to reach the target collection goal.
76825|NCT02104427|O5|Outcome|Post-leukapheresis|Circulating CD34+ Cell Count (cells/µL) in Peripheral Blood at Post-leukapheresis timepoint
76826|NCT02104427|O4|Outcome|Pre-leukapheresis|Circulating CD34+ Cell Count (cells/µL) in Peripheral Blood at Pre-leukapheresis timepoint
76827|NCT02104427|O3|Outcome|6h Post-infusion|Circulating CD34+ Cell Count (cells/µL) in Peripheral Blood at 6h post-infusion timepoint
76828|NCT02104427|O2|Outcome|4h Post-infusion|Circulating CD34+ Cell Count (cells/µL) in Peripheral Blood at 4h post-infusion timepoint
76829|NCT02104427|O1|Outcome|Pre-dose|Circulating CD34+ Cell Count (cells/µL) in Peripheral Blood at Pre-dose timepoint
76830|NCT02104427|O5|Outcome|Within 5 Leukapheresis Sessions|Cumulative CD34+ cell counts ≥6.0 x 10^6 cells/kg within 5 leukapheresis session
76831|NCT02104427|O4|Outcome|Within 4 Leukapheresis Sessions|Cumulative CD34+ cell counts ≥6.0 x 10^6 cells/kg within 4 leukapheresis session
76832|NCT02104427|O3|Outcome|Within 3 Leukapheresis Sessions|Cumulative CD34+ cell counts ≥6.0 x 10^6 cells/kg within 3 leukapheresis session
76833|NCT02104427|O2|Outcome|Within 2 Leukapheresis Sessions|Cumulative CD34+ cell counts ≥6.0 x 10^6 cells/kg within 2 leukapheresis session
76834|NCT02104427|O1|Outcome|Within 1 Leukapheresis Session|Cumulative CD34+ cell counts ≥6.0 x 10^6 cells/kg within 1 leukapheresis session
76835|NCT02104427|O4|Outcome|Within 4 Leukapheresis Sessions|Cumulative CD34+ cell counts ≥5.0 x 10^6 cells/kg within 4 leukapheresis session
76836|NCT02104427|O3|Outcome|Within 3 Leukapheresis Sessions|Cumulative CD34+ cell counts ≥2.5 x 10^6 cells/kg within 3 leukapheresis session
76837|NCT02104427|O2|Outcome|Within 2 Leukapheresis Sessions|Cumulative CD34+ cell counts ≥2.5 x 10^6 cells/kg within 2 leukapheresis session
76838|NCT02104427|O1|Outcome|Within 1 Leukapheresis Session|Cumulative CD34+ cell counts ≥2.5 x 10^6 cells/kg within 1 leukapheresis session
76839|NCT02104427|O4|Outcome|Within 4 Leukapheresis Sessions|Cumulative CD34+ cell counts ≥5.0 x 10^6 cells/kg within 4 leukapheresis session
76840|NCT02104427|O3|Outcome|Within 3 Leukapheresis Sessions|Cumulative CD34+ cell counts ≥5.0 x 10^6 cells/kg within 3 leukapheresis session
76841|NCT02104427|O2|Outcome|Within 2 Leukapheresis Sessions|Cumulative CD34+ cell counts ≥5.0 x 10^6 cells/kg within 2 leukapheresis session
76842|NCT02104427|O1|Outcome|Within 1 Leukapheresis Session|Cumulative CD34+ cell counts ≥5.0 x 10^6 cells/kg within 1 leukapheresis session
76843|NCT02104427|E3|Reported Event|Overall|
76844|NCT02104427|E2|Reported Event|10 µg/kg/Day G-CSF + 3.14 mg/kg TG-0054|Day 5 until end of study
76845|NCT02104427|E1|Reported Event|10 µg/kg/Day G-CSF Alone|Days 1 through 4
76846|NCT02104219|B1|Baseline|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
76847|NCT02104219|P1|Participant Flow|Retrospective Observational|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
76848|NCT02104219|O1|Outcome|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
76849|NCT02104219|O1|Outcome|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
76850|NCT02104219|O1|Outcome|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
76851|NCT02104219|O1|Outcome|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
76852|NCT02104219|E1|Reported Event|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
76853|NCT02103855|B1|Baseline|Belatacept|"Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes.~Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus.~Belatacept"
76854|NCT02103855|P1|Participant Flow|Belatacept|"Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes.~Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus.~Belatacept"
76855|NCT02103855|O1|Outcome|Belatacept|"Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes.~Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus.~Belatacept"
76856|NCT02103855|O1|Outcome|Belatacept|"Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes.~Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus.~Belatacept"
76857|NCT02103855|O1|Outcome|Belatacept|"Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes.~Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus.~Belatacept"
76858|NCT02103855|O1|Outcome|Belatacept|"Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes.~Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus.~Belatacept"
76859|NCT02103855|O1|Outcome|Belatacept|"Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes.~Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus.~Belatacept"
76860|NCT02103855|E1|Reported Event|Belatacept|"Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes.~Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus.~Belatacept"
76861|NCT02103439|B3|Baseline|Total|Total of all reporting groups
76862|NCT02103439|B2|Baseline|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
76863|NCT02103439|B1|Baseline|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
76864|NCT02103439|P2|Participant Flow|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
76865|NCT02103439|P1|Participant Flow|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
76866|NCT02103439|O2|Outcome|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
76867|NCT02103439|O1|Outcome|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
76868|NCT02103439|O4|Outcome|PegIntron - HCV-2/3|"Patients with HCV genotype 2 or 3, received PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
76869|NCT02103439|O3|Outcome|PegIntron - HCV-1|"Patients with HCV genotype 1, received PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
76870|NCT02103439|O2|Outcome|Algeron - HCV-2/3|"Patients with HCV genotype 2 or 3, received Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
76871|NCT02103439|O1|Outcome|Algeron - HCV-1|"Patients with HCV genotype 1, received Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
76872|NCT02103439|O2|Outcome|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
76903|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76873|NCT02103439|O1|Outcome|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
76874|NCT02103439|O4|Outcome|PegIntron - HCV-2/3|"Patients with HCV genotype 2 or 3, received PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
76875|NCT02103439|O3|Outcome|PegIntron - HCV-1|"Patients with HCV genotype 1, received PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
76876|NCT02103439|O2|Outcome|Algeron - HCV-2/3|"Patients with HCV genotype 2 or 3, received Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
76877|NCT02103439|O1|Outcome|Algeron - HCV-1|"Patients with HCV genotype 1, received Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
76878|NCT02103439|O2|Outcome|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
76879|NCT02103439|O1|Outcome|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
76880|NCT02103439|O2|Outcome|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
76881|NCT02103439|O1|Outcome|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
76882|NCT02103439|E2|Reported Event|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week~The safety analysis included 71 patients received at least 1 dose of PegIntron (taking into account one patient withdrawn at early stages of the study due to a protocol violation [previous treatment of hepatitis C with interferon alfa], who was withdrawn from the mITT-analysis)"
76883|NCT02103439|E1|Reported Event|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
76884|NCT02103309|B1|Baseline|Overall|DAILIES® AquaComfort Plus® and 1-Day ACUVUE® MOIST® contact lenses worn in a crossover assignment.
76885|NCT02103309|P2|Participant Flow|1DAM, Then DACP|Etafilcon A contact lenses worn first, then nelfilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
76886|NCT02103309|P1|Participant Flow|DACP, Then 1DAM|Nelfilcon A contact lenses worn first, then etafilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
76887|NCT02103309|O2|Outcome|1DAM|Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
76888|NCT02103309|O1|Outcome|DACP|Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
76889|NCT02103309|O2|Outcome|1DAM|Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
76890|NCT02103309|O1|Outcome|DACP|Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
76891|NCT02103309|O2|Outcome|1DAM|Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
76892|NCT02103309|O1|Outcome|DACP|Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
76893|NCT02103309|O2|Outcome|1DAM|Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
76894|NCT02103309|O1|Outcome|DACP|Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
76895|NCT02103309|E2|Reported Event|1DAM|Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
76896|NCT02103309|E1|Reported Event|DACP|Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
76897|NCT02103114|B3|Baseline|Total|Total of all reporting groups
76898|NCT02103114|B2|Baseline|Placebo|Placebo: Normal saline placebo
76899|NCT02103114|B1|Baseline|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76900|NCT02103114|P2|Participant Flow|Placebo|Normal saline placebo
76901|NCT02103114|P1|Participant Flow|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76905|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76906|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
76907|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76908|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
76909|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76910|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
76911|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76912|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
76913|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76914|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
76915|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76916|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
76917|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76918|NCT02103114|O2|Outcome|Placebo|Placebo: Normal saline placebo
76919|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76920|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
76921|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76922|NCT02103114|O2|Outcome|Placebo|Placebo: Normal saline placebo
76923|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76924|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
76925|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76926|NCT02103114|O2|Outcome|Placebo|Placebo: Normal saline placebo
76927|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76928|NCT02103114|O2|Outcome|Placebo|Placebo: Normal saline placebo
76929|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76930|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
76931|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76932|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
76933|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76934|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
76935|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76936|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
76937|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76938|NCT02103114|O2|Outcome|Placebo|Placebo: Normal saline placebo
76939|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76940|NCT02103114|O2|Outcome|Placebo|Placebo: Normal saline placebo
76941|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76942|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
76943|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76944|NCT02103114|O2|Outcome|Placebo|Placebo: Normal saline placebo
76945|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76946|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
76947|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76948|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
76949|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76950|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
76951|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76952|NCT02103114|E2|Reported Event|Placebo|Normal saline placebo
76953|NCT02103114|E1|Reported Event|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"
76954|NCT02103062|B3|Baseline|Total|Total of all reporting groups
76955|NCT02103062|B2|Baseline|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
76956|NCT02103062|B1|Baseline|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
76957|NCT02103062|P2|Participant Flow|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
76958|NCT02103062|P1|Participant Flow|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
76959|NCT02103062|O2|Outcome|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
76960|NCT02103062|O1|Outcome|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
76961|NCT02103062|O2|Outcome|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
76962|NCT02103062|O1|Outcome|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
76963|NCT02103062|O2|Outcome|RAS Mutated Abraxane (Nab®-Paclitaxel)|Abraxane (nab®-paclitaxel) 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
76964|NCT02103062|O1|Outcome|RAS Wildtype Abraxane (Nab®-Paclitaxel)|Abraxane (nab®-paclitaxel) 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
76965|NCT02103062|O2|Outcome|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
76966|NCT02103062|O1|Outcome|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
76967|NCT02103062|O2|Outcome|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
76968|NCT02103062|O1|Outcome|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
76969|NCT02103062|O2|Outcome|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
76970|NCT02103062|O1|Outcome|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
76971|NCT02103062|O2|Outcome|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
76972|NCT02103062|O1|Outcome|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
76973|NCT02103062|E2|Reported Event|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
76974|NCT02103062|E1|Reported Event|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
76975|NCT02102932|B9|Baseline|Total|Total of all reporting groups
76976|NCT02102932|B8|Baseline|R4T4|"Study Part 4:~R4: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg; T4: Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin; A washout period of at least 7 days was to be maintained between R4 and T4"
76977|NCT02102932|B7|Baseline|T4R4|"Study Part 4:~T4: Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin R4: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg; A washout period of at least 7 days was to be maintained between T4 and R4."
76978|NCT02102932|B6|Baseline|R3T3|"Study Part 3:~R3: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg T3: Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin; A washout period of at least 7 days was to be maintained between R3 and T3"
76979|NCT02102932|B5|Baseline|T3R3|"Study Part 3:~T3: Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin R3: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg; A washout period of at least 7 days was to be maintained between T3 and R3."
77015|NCT02102932|O1|Outcome|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
76980|NCT02102932|B4|Baseline|R2T2|"Study part 2:~R2: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg; T2: Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin; A washout period of at least 7 days was to be maintained between R2 and T2."
76981|NCT02102932|B3|Baseline|T2R2|"Study Part 2:~T2: Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin R2: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg; A washout period of at least 7 days was to be maintained between T2 and R2."
76982|NCT02102932|B2|Baseline|R1T1|"Study Part 1:~R1: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg T1: Oral administration of a single FDC tablet 12.5 mg empagliflozin/850 mg metformin; A washout period of at least 7 days was to be maintained between R1 and T1."
76983|NCT02102932|B1|Baseline|T1R1|"Study Part 1:~T1: Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin R1: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg; A washout period of at least 7 days was to be maintained between T1 and R1."
76984|NCT02102932|P8|Participant Flow|R4T4|"Study Part 4:~R4: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg; T4: Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin; A washout period of at least 7 days was to be maintained between R4 and T4"
76985|NCT02102932|P7|Participant Flow|T4R4|"Study Part 4:~T4: Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin R4: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg; A washout period of at least 7 days was to be maintained between T4 and R4."
76986|NCT02102932|P6|Participant Flow|R3T3|"Study Part 3:~R3: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg T3: Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin; A washout period of at least 7 days was to be maintained between R3 and T3"
76987|NCT02102932|P5|Participant Flow|T3R3|"Study Part 3:~T3: Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin R3: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg; A washout period of at least 7 days was to be maintained between T3 and R3."
76988|NCT02102932|P4|Participant Flow|R2T2|"Study part 2:~R2: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg; T2: Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin; A washout period of at least 7 days was to be maintained between R2 and T2."
76989|NCT02102932|P3|Participant Flow|T2R2|"Study Part 2:~T2: Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin R2: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg; A washout period of at least 7 days was to be maintained between T2 and R2."
76990|NCT02102932|P2|Participant Flow|R1T1|"Study Part 1:~R1: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg T1: Oral administration of a single FDC tablet 12.5 mg empagliflozin/850 mg metformin; A washout period of at least 7 days was to be maintained between R1 and T1."
76991|NCT02102932|P1|Participant Flow|T1R1|"Study Part 1:~T1: Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin R1: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg; A washout period of at least 7 days was to be maintained between T1 and R1."
76992|NCT02102932|O8|Outcome|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
76993|NCT02102932|O7|Outcome|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
76994|NCT02102932|O6|Outcome|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
76995|NCT02102932|O5|Outcome|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
76996|NCT02102932|O4|Outcome|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
76997|NCT02102932|O3|Outcome|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
76998|NCT02102932|O2|Outcome|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
76999|NCT02102932|O1|Outcome|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
77000|NCT02102932|O8|Outcome|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
77001|NCT02102932|O7|Outcome|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
77002|NCT02102932|O6|Outcome|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
77003|NCT02102932|O5|Outcome|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
77004|NCT02102932|O4|Outcome|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
77005|NCT02102932|O3|Outcome|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
77006|NCT02102932|O2|Outcome|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
77007|NCT02102932|O1|Outcome|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
77008|NCT02102932|O8|Outcome|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
77009|NCT02102932|O7|Outcome|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
77010|NCT02102932|O6|Outcome|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
77011|NCT02102932|O5|Outcome|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
77012|NCT02102932|O4|Outcome|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
77013|NCT02102932|O3|Outcome|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
77014|NCT02102932|O2|Outcome|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
77016|NCT02102932|O8|Outcome|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
77017|NCT02102932|O7|Outcome|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
77018|NCT02102932|O6|Outcome|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
77019|NCT02102932|O5|Outcome|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
77020|NCT02102932|O4|Outcome|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
77021|NCT02102932|O3|Outcome|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
77022|NCT02102932|O2|Outcome|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
77023|NCT02102932|O1|Outcome|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
77024|NCT02102932|O8|Outcome|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
77025|NCT02102932|O7|Outcome|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
77026|NCT02102932|O6|Outcome|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
77027|NCT02102932|O5|Outcome|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
77028|NCT02102932|O4|Outcome|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
77029|NCT02102932|O3|Outcome|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
77030|NCT02102932|O2|Outcome|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
77031|NCT02102932|O1|Outcome|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
77032|NCT02102932|O8|Outcome|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
77033|NCT02102932|O7|Outcome|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
77034|NCT02102932|O6|Outcome|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
77035|NCT02102932|O5|Outcome|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
77036|NCT02102932|O4|Outcome|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
77037|NCT02102932|O3|Outcome|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
77038|NCT02102932|O2|Outcome|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
77039|NCT02102932|O1|Outcome|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
77040|NCT02102932|E8|Reported Event|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
77041|NCT02102932|E7|Reported Event|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
77042|NCT02102932|E6|Reported Event|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
77043|NCT02102932|E5|Reported Event|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
77044|NCT02102932|E4|Reported Event|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
77045|NCT02102932|E3|Reported Event|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
77046|NCT02102932|E2|Reported Event|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
77047|NCT02102932|E1|Reported Event|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
77048|NCT02102490|B1|Baseline|Abemaciclib|200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
77049|NCT02102490|P1|Participant Flow|Abemaciclib|200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
77050|NCT02102490|O1|Outcome|Abemaciclib|200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
77051|NCT02102490|O1|Outcome|Abemaciclib|200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
77052|NCT02102490|O1|Outcome|Abemaciclib|200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
77053|NCT02102490|O1|Outcome|Abemaciclib|200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
77054|NCT02102490|O1|Outcome|Abemaciclib|200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
77055|NCT02102490|O1|Outcome|Abemaciclib|200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
77056|NCT02102490|O1|Outcome|Abemaciclib|200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
77057|NCT02102490|O1|Outcome|Abemaciclib|200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
77058|NCT02102490|O1|Outcome|Abemaciclib|200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
78035|NCT02096900|E2|Reported Event|Zolpidem|zolpidem was given orally 0.25mg/kg pre-operatively single dose
77059|NCT02102490|E1|Reported Event|Abemaciclib|200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
77060|NCT02102464|B3|Baseline|Total|Total of all reporting groups
77061|NCT02102464|B2|Baseline|Untreated Control|Untreated Control (No Intervention)
77062|NCT02102464|B1|Baseline|LipiFlow|"Single 12-minute LipiFlow treatment~LipiFlow treatment: The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
77063|NCT02102464|P3|Participant Flow|Crossover LipiFlow|Untreated Control Subjects received a 12-minute LipiFlow treatment after the 3-month visit
77064|NCT02102464|P2|Participant Flow|Untreated Control|Untreated Control (No Intervention)
77065|NCT02102464|P1|Participant Flow|LipiFlow|"Single 12-minute LipiFlow treatment~LipiFlow treatment: The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
77066|NCT02102464|O2|Outcome|Crossover LipiFlow Group|Untreated Control Subjects received a 12-minute LipiFlow treatment after the 3-month visit
77067|NCT02102464|O1|Outcome|LipiFlow|"Single 12-minute LipiFlow treatment~LipiFlow treatment: The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
77068|NCT02102464|O2|Outcome|Crossover LipiFlow|Untreated Control Subjects received a 12-minute LipiFlow treatment after the 3-month visit
77069|NCT02102464|O1|Outcome|LipiFlow|"Single 12-minute LipiFlow treatment~LipiFlow treatment: The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
77070|NCT02102464|O2|Outcome|Crossover LipiFlow Group|Untreated Control Subjects received a 12-minute LipiFlow treatment after the 3-month visit
77071|NCT02102464|O1|Outcome|LipiFlow|"Single 12-minute LipiFlow treatment~LipiFlow treatment: The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
77072|NCT02102464|O2|Outcome|Untreated Control|Untreated Control (No Intervention)
77073|NCT02102464|O1|Outcome|LipiFlow|"Single 12-minute LipiFlow treatment~LipiFlow treatment: The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
77074|NCT02102464|O2|Outcome|Untreated Control|Untreated Control (No Intervention)
77075|NCT02102464|O1|Outcome|LipiFlow|"Single 12-minute LipiFlow treatment~LipiFlow treatment: The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
77076|NCT02102464|O2|Outcome|Untreated Control|Untreated Control (No Intervention)
77077|NCT02102464|O1|Outcome|LipiFlow|"Single 12-minute LipiFlow treatment~LipiFlow treatment: The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
77078|NCT02102464|E3|Reported Event|Crossover LipiFlow Group|Untreated Control Group received a single 12-minute Crossover LipiFlow treatment at the 3-Months visit.
77079|NCT02102464|E2|Reported Event|Untreated Control|Untreated Control (No Intervention)
77080|NCT02102464|E1|Reported Event|LipiFlow|"Single 12-minute LipiFlow treatment~LipiFlow treatment: The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
77081|NCT02102399|B3|Baseline|Total|Total of all reporting groups
77082|NCT02102399|B2|Baseline|Respiratory Muscle Training|Respiratory Muscle Training group was performed during 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
77083|NCT02102399|B1|Baseline|Vocal Warm-up|Vocal Warm up group was performed during 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
77084|NCT02102399|P2|Participant Flow|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
77085|NCT02102399|P1|Participant Flow|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
77086|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
77087|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
77088|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
77089|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
77090|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
77091|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
77092|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day
77093|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
77094|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day
77095|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
77096|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day
77097|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
77098|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day
77099|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
77100|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day
77101|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
77102|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day
77103|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
77104|NCT02102399|O2|Outcome|Vocal Warm-up (Posttest)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
77105|NCT02102399|O1|Outcome|Vocal Warm-up (Baseline)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
77106|NCT02102399|O2|Outcome|Vocal Warm-up (Posttest)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
77107|NCT02102399|O1|Outcome|Vocal Warm-up (Baseline)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
77108|NCT02102399|O2|Outcome|Vocal Warm-up (Posttest)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
77109|NCT02102399|O1|Outcome|Vocal Warm-up (Baseline)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
77110|NCT02102399|O2|Outcome|Vocal Warm-up (Posttest)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
77111|NCT02102399|O1|Outcome|Vocal Warm-up (Baseline)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
77112|NCT02102399|O2|Outcome|Vocal Warm-up (Posttest)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
77113|NCT02102399|O1|Outcome|Vocal Warm-up (Baseline)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
77114|NCT02102399|O2|Outcome|Vocal Warm-up (Posttest)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
77115|NCT02102399|O1|Outcome|Vocal Warm-up (Baseline)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
77116|NCT02102399|O2|Outcome|Respiratory Muscle Training (Posttest)|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
77117|NCT02102399|O1|Outcome|Respiratory Muscle Training (Baseline)|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
77118|NCT02102399|O2|Outcome|Respiratory Muscle Training (Posttest)|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
77119|NCT02102399|O1|Outcome|Respiratory Muscle Training (Baseline)|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
77120|NCT02102399|O2|Outcome|Respiratory Muscle Training (Posttest)|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
77121|NCT02102399|O1|Outcome|Respiratory Muscle Training (Baseline)|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
77122|NCT02102399|O2|Outcome|Respiratory Muscle Training (Posttest)|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
78736|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
77123|NCT02102399|O1|Outcome|Respiratory Muscle Training (Baseline)|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
77124|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
77125|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
77126|NCT02102399|O2|Outcome|Respiratory Muscle Training (Posttest)|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
77127|NCT02102399|O1|Outcome|Respiratory Muscle Training (Baseline)|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
77128|NCT02102399|O2|Outcome|Respiratory Muscle Training (Posttest)|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
77129|NCT02102399|O1|Outcome|Respiratory Muscle Training (Baseline)|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
77130|NCT02102399|E2|Reported Event|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
77131|NCT02102399|E1|Reported Event|Vocal Warm-up|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
77132|NCT02102204|B1|Baseline|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) by bolus injection at the end of hemodialysis. The minimum etelcalcetide dose in this study was 2.5 mg and the maximum dose was 15 mg. Etelcalcetide dose was titrated to maintain parathyroid hormone levels within 2x to 9x the upper limit of normal based on the reference range of the assay used at the individual study center.
77133|NCT02102204|P1|Participant Flow|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) by bolus injection at the end of hemodialysis. The minimum etelcalcetide dose in this study was 2.5 mg and the maximum dose was 15 mg. Etelcalcetide dose was titrated to maintain parathyroid hormone levels within 2x to 9x the upper limit of normal based on the reference range of the assay used at the individual study center.
77134|NCT02102204|O1|Outcome|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) by bolus injection at the end of hemodialysis. The minimum etelcalcetide dose in this study was 2.5 mg and the maximum dose was 15 mg. Etelcalcetide dose was titrated to maintain parathyroid hormone levels within 2x to 9x the upper limit of normal based on the reference range of the assay used at the individual study center.
77135|NCT02102204|O1|Outcome|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) by bolus injection at the end of hemodialysis. The minimum etelcalcetide dose in this study was 2.5 mg and the maximum dose was 15 mg. Etelcalcetide dose was titrated to maintain parathyroid hormone levels within 2x to 9x the upper limit of normal based on the reference range of the assay used at the individual study center.
77136|NCT02102204|O1|Outcome|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) by bolus injection at the end of hemodialysis. The minimum etelcalcetide dose in this study was 2.5 mg and the maximum dose was 15 mg. Etelcalcetide dose was titrated to maintain parathyroid hormone levels within 2x to 9x the upper limit of normal based on the reference range of the assay used at the individual study center.
77137|NCT02102204|O1|Outcome|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) by bolus injection at the end of hemodialysis. The minimum etelcalcetide dose in this study was 2.5 mg and the maximum dose was 15 mg. Etelcalcetide dose was titrated to maintain parathyroid hormone levels within 2x to 9x the upper limit of normal based on the reference range of the assay used at the individual study center.
77138|NCT02102204|O1|Outcome|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) by bolus injection at the end of hemodialysis. The minimum etelcalcetide dose in this study was 2.5 mg and the maximum dose was 15 mg. Etelcalcetide dose was titrated to maintain parathyroid hormone levels within 2x to 9x the upper limit of normal based on the reference range of the assay used at the individual study center.
77139|NCT02102204|O1|Outcome|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) by bolus injection at the end of hemodialysis. The minimum etelcalcetide dose in this study was 2.5 mg and the maximum dose was 15 mg. Etelcalcetide dose was titrated to maintain parathyroid hormone levels within 2x to 9x the upper limit of normal based on the reference range of the assay used at the individual study center.
77140|NCT02102204|E1|Reported Event|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) by bolus injection at the end of hemodialysis. The minimum etelcalcetide dose in this study was 2.5 mg and the maximum dose was 15 mg. Etelcalcetide dose was titrated to maintain parathyroid hormone levels within 2x to 9x the upper limit of normal based on the reference range of the assay used at the individual study center.
77141|NCT02101359|B3|Baseline|Total|Total of all reporting groups
77142|NCT02101359|B2|Baseline|Reference Group|Mydriatics and anesthetic: Topical treatments used the day of surgery
77143|NCT02101359|B1|Baseline|T2380|T2380: Intracameral administration during surgery
77144|NCT02101359|P2|Participant Flow|Reference Group|Mydriatics and anesthetics: Topical treatments used the day of surgery
77145|NCT02101359|P1|Participant Flow|T2380|T2380: Intracameral administration during surgery
77146|NCT02101359|O2|Outcome|Reference Group|Mydriatics and anesthetic: Topical treatments used the day of surgery
77147|NCT02101359|O1|Outcome|T2380|T2380: Intracameral administration during surgery
77148|NCT02101359|E2|Reported Event|Reference Group|Mydriatics and anesthetic: Topical treatments used the day of surgery
77149|NCT02101359|E1|Reported Event|T2380|T2380: Intracameral administration during surgery
77150|NCT02101294|B1|Baseline|Interossei Lumbricals Neuro Interface|Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device.
77151|NCT02101294|P1|Participant Flow|Interossei Lumbricals Neuro Interface|"Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device.~Interossei Lumbricals Neuro Interface: Finger Relief's keyboard home row layout [actual home row placement order: asdeihotlrn], plus substitutions on the upper row [qwfgjyuk;p] and bottom row [zxcvb'm,.] moves or shifts finger and thumb movement from the elbow muscles to the finger muscles. The movement of finger bending toward the palm is shifted to the interosseous and lumbrical muscles of the hand and fingers from the full flexion and extension muscle control to reduce contraction and expansion of tendons and the movement in the carpal canal adjacent to the median nerve and reduces pressure on the median nerve. Pressure on the median nerve compromises the nerve leading to symptoms of the carpal tunnel syndrome of pain, tingling, and numbness."
77152|NCT02101294|O1|Outcome|Measurement of Wrist Swelling Following FingerRelief|Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device. These are the results of the tape measurement of wrist swelling following typing with the FingerRelief keyboard.
77153|NCT02101294|O1|Outcome|Length of Time Typing With FingerRelief|Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device. These are the results of the length of time the patients typed with the FingerRelief keyboard prior to stopping, averaged across two typing sessions.
77154|NCT02101294|O1|Outcome|Measurement of Wrist Swelling Following Typing With QWERTY|Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device. These are the results of the tape measurement of wrist swelling following typing with the QWERTY keyboard.
77155|NCT02101294|O1|Outcome|Length of Time Typing With QWERTY|Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device. These are the results of the length of time the patients typed with the QWERTY keyboard prior to stopping, averaged across two typing sessions.
77156|NCT02101294|E1|Reported Event|Interossei Lumbricals Neuro Interface|"Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device.~Interossei Lumbricals Neuro Interface: Finger Relief's keyboard home row layout [actual home row placement order: asdeihotlrn], plus substitutions on the upper row [qwfgjyuk;p] and bottom row [zxcvb'm,.] moves or shifts finger and thumb movement from the elbow muscles to the finger muscles. The movement of finger bending toward the palm is shifted to the interosseous and lumbrical muscles of the hand and fingers from the full flexion and extension muscle control to reduce contraction and expansion of tendons and the movement in the carpal canal adjacent to the median nerve and reduces pressure on the median nerve. Pressure on the median nerve compromises the nerve leading to symptoms of the carpal tunnel syndrome of pain, tingling, and numbness."
77157|NCT02101190|B3|Baseline|Total|Total of all reporting groups
77158|NCT02101190|B2|Baseline|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
77159|NCT02101190|B1|Baseline|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
77160|NCT02101190|P2|Participant Flow|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
77161|NCT02101190|P1|Participant Flow|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
77162|NCT02101190|O2|Outcome|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
77163|NCT02101190|O1|Outcome|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
77164|NCT02101190|O2|Outcome|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
77165|NCT02101190|O1|Outcome|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
77166|NCT02101190|O2|Outcome|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
77167|NCT02101190|O1|Outcome|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
77168|NCT02101190|E2|Reported Event|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
77169|NCT02101190|E1|Reported Event|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
77170|NCT02101112|B1|Baseline|Apixaban, 10 mg (Whole Tablets)|This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment.
77171|NCT02101112|P6|Participant Flow|Treatment C Then Treatment B Then Treatment A|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.~Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.~Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce~This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
77172|NCT02101112|P5|Participant Flow|Treatment C Then Treatment A Then Treatment B|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.~Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.~Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce~This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
77173|NCT02101112|P4|Participant Flow|Treatment B Then Treatment A Then Treatment C|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.~Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.~Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce~This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
77174|NCT02101112|P3|Participant Flow|Treatment B Then Treatment C Then Treatment A|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.~Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.~Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce~This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
77175|NCT02101112|P2|Participant Flow|Treatment A Then Treatment C Then Treatment B|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.~Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.~Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce~This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
77176|NCT02101112|P1|Participant Flow|Treatment A Then Treatment B Then Treatment C|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.~Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.~Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce~This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
77177|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
77178|NCT02101112|O1|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
77179|NCT02101112|O3|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
77180|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
77181|NCT02101112|O1|Outcome|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
77182|NCT02101112|O3|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
77183|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
77184|NCT02101112|O1|Outcome|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
77185|NCT02101112|O3|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
77186|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
78737|NCT02093923|E5|Reported Event|Placebo|Placebo administered twice, two weeks apart
77187|NCT02101112|O1|Outcome|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
77188|NCT02101112|O3|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
77189|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
77190|NCT02101112|O1|Outcome|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
77191|NCT02101112|O3|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
77192|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
77193|NCT02101112|O1|Outcome|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
77194|NCT02101112|O3|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
77195|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
77196|NCT02101112|O1|Outcome|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
77197|NCT02101112|E3|Reported Event|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
77198|NCT02101112|E2|Reported Event|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
77199|NCT02101112|E1|Reported Event|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
77200|NCT02101021|B6|Baseline|Total|Total of all reporting groups
77201|NCT02101021|B5|Baseline|MMB Dose Level 5|MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77202|NCT02101021|B4|Baseline|MMB Dose Level 4|MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77203|NCT02101021|B3|Baseline|MMB Dose Level 3|MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77204|NCT02101021|B2|Baseline|MMB Dose Level 2|MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77205|NCT02101021|B1|Baseline|MMB Dose Level 1|MMB 100 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77206|NCT02101021|P5|Participant Flow|MMB Dose Level 5|MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77207|NCT02101021|P4|Participant Flow|MMB Dose Level 4|MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77208|NCT02101021|P3|Participant Flow|MMB Dose Level 3|MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77209|NCT02101021|P2|Participant Flow|MMB Dose Level 2|MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77210|NCT02101021|P1|Participant Flow|MMB Dose Level 1|Momelotinib (MMB) 100 mg tablet once daily + albumin-bound (nab)-paclitaxel plus gemcitabine (nab-P+G) (1000+1000 mg/m^2) intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle
77211|NCT02101021|O5|Outcome|MMB Dose Level 5|MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77212|NCT02101021|O4|Outcome|MMB Dose Level 4|MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77213|NCT02101021|O3|Outcome|MMB Dose Level 3|MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77214|NCT02101021|O2|Outcome|MMB Dose Level 2|MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77215|NCT02101021|O1|Outcome|MMB Dose Level 1|MMB 100 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77216|NCT02101021|O5|Outcome|MMB Dose Level 5|MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77217|NCT02101021|O4|Outcome|MMB Dose Level 4|MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77218|NCT02101021|O3|Outcome|MMB Dose Level 3|MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77219|NCT02101021|O2|Outcome|MMB Dose Level 2|MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77220|NCT02101021|O1|Outcome|MMB Dose Level 1|MMB 100 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77221|NCT02101021|O5|Outcome|MMB Dose Level 5|MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77222|NCT02101021|O4|Outcome|MMB Dose Level 4|MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77223|NCT02101021|O3|Outcome|MMB Dose Level 3|MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77224|NCT02101021|O2|Outcome|MMB Dose Level 2|MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77225|NCT02101021|O1|Outcome|MMB Dose Level 1|MMB 100 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
78036|NCT02096900|E1|Reported Event|Midazolam|midazolam was given at 0.5mg/kg, pre-operatively single dose
77226|NCT02101021|O5|Outcome|MMB Dose Level 5|MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77227|NCT02101021|O4|Outcome|MMB Dose Level 4|MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77228|NCT02101021|O3|Outcome|MMB Dose Level 3|MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77229|NCT02101021|O2|Outcome|MMB Dose Level 2|MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77230|NCT02101021|O1|Outcome|MMB Dose Level 1|MMB 100 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77231|NCT02101021|O5|Outcome|MMB Dose Level 5|MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77232|NCT02101021|O4|Outcome|MMB Dose Level 4|MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77233|NCT02101021|O3|Outcome|MMB Dose Level 3|MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77234|NCT02101021|O2|Outcome|MMB Dose Level 2|MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77235|NCT02101021|O1|Outcome|MMB Dose Level 1|MMB 100 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77236|NCT02101021|O5|Outcome|MMB Dose Level 5|MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77237|NCT02101021|O4|Outcome|MMB Dose Level 4|MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77238|NCT02101021|O3|Outcome|MMB Dose Level 3|MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77239|NCT02101021|O2|Outcome|MMB Dose Level 2|MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77240|NCT02101021|O1|Outcome|MMB Dose Level 1|MMB 100 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77241|NCT02101021|O5|Outcome|MMB Dose Level 5|MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77242|NCT02101021|O4|Outcome|MMB Dose Level 4|MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77243|NCT02101021|O3|Outcome|MMB Dose Level 3|MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77244|NCT02101021|O2|Outcome|MMB Dose Level 2|MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77245|NCT02101021|O1|Outcome|MMB Dose Level 1|MMB 100 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77246|NCT02101021|E5|Reported Event|MMB Dose Level 5|MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77247|NCT02101021|E4|Reported Event|MMB Dose Level 4|MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77248|NCT02101021|E3|Reported Event|MMB Dose Level 3|MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77249|NCT02101021|E2|Reported Event|MMB Dose Level 2|MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77250|NCT02101021|E1|Reported Event|MMB Dose Level 1|MMB 100 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
77251|NCT02101008|B1|Baseline|Disulfiram and Chelated Zinc|"There is only one arm. All patients are treated wtih disulfiram and chelated zinc.~disulfiram and chelated zinc"
77252|NCT02101008|P1|Participant Flow|Disulfiram and Chelated Zinc|There is only one arm. All patients are treated wtih disulfiram and chelated zinc. Disulfiram will be administered at a fixed dose of 250 mg orally per day at bedtime. Chelated zinc will be given at a dose of 50 mg orally 3 times a day (with each meal).
77253|NCT02101008|O1|Outcome|Disulfiram and Chelated Zinc|There is only one arm. All patients are treated wtih disulfiram and chelated zinc. Disulfiram will be administered at a fixed dose of 250 mg orally per day at bedtime. Chelated zinc will be given at a dose of 50 mg orally 3 times a day (with each meal).
77254|NCT02101008|O1|Outcome|Disulfiram and Chelated Zinc|There is only one arm. All patients are treated wtih disulfiram and chelated zinc. Disulfiram will be administered at a fixed dose of 250 mg orally per day at bedtime. Chelated zinc will be given at a dose of 50 mg orally 3 times a day (with each meal).
77255|NCT02101008|E1|Reported Event|Disulfiram and Chelated Zinc|"There is only one arm. All patients are treated wtih disulfiram and chelated zinc.~disulfiram and chelated zinc"
77256|NCT02100839|B3|Baseline|Total|Total of all reporting groups
77257|NCT02100839|B2|Baseline|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.~Normal Saline: 0.9% saline for injection"
77258|NCT02100839|B1|Baseline|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.~AEM-28: Solution for injection"
77259|NCT02100839|P2|Participant Flow|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.~Normal Saline: 0.9% saline for injection"
77260|NCT02100839|P1|Participant Flow|Apolipoprotein E Mimetic (AEM)-28|"Single Ascending Dose (SAD): Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL~Multiple Ascending Dose (MAD): Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.~AEM-28: Solution for injection"
77261|NCT02100839|O2|Outcome|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.~Normal Saline: 0.9% saline for injection"
77262|NCT02100839|O1|Outcome|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.~AEM-28: Solution for injection"
77263|NCT02100839|O2|Outcome|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.~Normal Saline: 0.9% saline for injection"
77264|NCT02100839|O1|Outcome|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.~AEM-28: Solution for injection"
77265|NCT02100839|O2|Outcome|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.~Normal Saline: 0.9% saline for injection"
77266|NCT02100839|O1|Outcome|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.~AEM-28: Solution for injection"
77267|NCT02100839|O2|Outcome|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.~Normal Saline: 0.9% saline for injection"
77268|NCT02100839|O1|Outcome|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.~AEM-28: Solution for injection"
77269|NCT02100839|E2|Reported Event|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.~Normal Saline: 0.9% saline for injection"
77270|NCT02100839|E1|Reported Event|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.~AEM-28: Solution for injection"
77271|NCT02100826|B1|Baseline|Overall Study|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).
77272|NCT02100826|P2|Participant Flow|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test – 1 occasion) and Cephalexin A formulation (Treatment A, Reference – 1 occasion).There was an interval of 1 day between doses.
77273|NCT02100826|P1|Participant Flow|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).There was an interval of 1 day between doses.
77274|NCT02100826|O2|Outcome|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
77275|NCT02100826|O1|Outcome|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
77276|NCT02100826|O2|Outcome|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
77277|NCT02100826|O1|Outcome|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
77278|NCT02100826|O2|Outcome|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
77279|NCT02100826|O1|Outcome|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
77280|NCT02100826|E2|Reported Event|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
77281|NCT02100826|E1|Reported Event|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
77282|NCT02100670|B5|Baseline|Total|Total of all reporting groups
77283|NCT02100670|B4|Baseline|Placebo|Placebo with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77284|NCT02100670|B3|Baseline|3% Menthol|3% menthol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77285|NCT02100670|B2|Baseline|1% Diclofenac Sodium|1% diclofenac sodium with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77286|NCT02100670|B1|Baseline|1% Diclofenac Sodium+3% Menthol|1% diclofenac sodium with 3% menthol gel was supplied in 30 gram (g) tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77287|NCT02100670|P4|Participant Flow|Placebo|Placebo with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77288|NCT02100670|P3|Participant Flow|3% Menthol|3% menthol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77289|NCT02100670|P2|Participant Flow|1% Diclofenac Sodium|1% diclofenac sodium with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77290|NCT02100670|P1|Participant Flow|1% Diclofenac Sodium+3% Menthol|1% diclofenac sodium with 3% menthol gel was supplied in 30 gram (g) tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77291|NCT02100670|O4|Outcome|Placebo|Placebo with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77292|NCT02100670|O3|Outcome|3% Menthol|3% menthol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77293|NCT02100670|O2|Outcome|1% Diclofenac Sodium|1% diclofenac sodium with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77294|NCT02100670|O1|Outcome|1% Diclofenac Sodium+3% Menthol|1% diclofenac sodium+3% menthol gel was supplied in 30 gram (g) tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
78037|NCT02096861|B5|Baseline|Total|Total of all reporting groups
77295|NCT02100670|O4|Outcome|Placebo|Placebo with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77296|NCT02100670|O3|Outcome|3% Menthol|3% menthol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77297|NCT02100670|O2|Outcome|1% Diclofenac Sodium|1% diclofenac sodium with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77298|NCT02100670|O1|Outcome|1% Diclofenac Sodium+3% Menthol|1% diclofenac sodium+3% menthol gel was supplied in 30 gram (g) tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77299|NCT02100670|O4|Outcome|Placebo|Placebo with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77300|NCT02100670|O3|Outcome|3% Menthol|3% menthol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77301|NCT02100670|O2|Outcome|1% Diclofenac Sodium|1% diclofenac sodium with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77302|NCT02100670|O1|Outcome|1% Diclofenac Sodium+3% Menthol|1% diclofenac sodium+3% menthol gel was supplied in 30 gram (g) tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77303|NCT02100670|O4|Outcome|Placebo|Placebo with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77304|NCT02100670|O3|Outcome|3% Menthol|3% menthol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77305|NCT02100670|O2|Outcome|1% Diclofenac Sodium|1% diclofenac sodium with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77306|NCT02100670|O1|Outcome|1% Diclofenac Sodium+3% Menthol|1% diclofenac sodium+3% menthol gel was supplied in 30 gram (g) tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77307|NCT02100670|O4|Outcome|Placebo|Placebo with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77308|NCT02100670|O3|Outcome|3% Menthol|3% menthol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77309|NCT02100670|O2|Outcome|1% Diclofenac Sodium|1% diclofenac sodium with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77310|NCT02100670|O1|Outcome|1% Diclofenac Sodium+3% Menthol|1% diclofenac sodium+3% menthol gel was supplied in 30 gram (g) tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77311|NCT02100670|O4|Outcome|Placebo|Placebo with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77312|NCT02100670|O3|Outcome|3% Menthol|3% menthol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77313|NCT02100670|O2|Outcome|1% Diclofenac Sodium|1% diclofenac sodium with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77314|NCT02100670|O1|Outcome|1% Diclofenac Sodium+3% Menthol|1% diclofenac sodium+3% menthol gel was supplied in 30 gram (g) tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77315|NCT02100670|O4|Outcome|Placebo|Placebo with 0.09% methanol gel was supplied in 30g tubes sufficient for each participants to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77316|NCT02100670|O3|Outcome|3% Menthol|3% menthol gel was supplied in 30g tubes sufficient for each participants to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77317|NCT02100670|O2|Outcome|1% Diclofenac Sodium|1% diclofenac sodium with 0.09% methanol gel was supplied in 30g tubes sufficient for each participants to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77318|NCT02100670|O1|Outcome|1% Diclofenac Sodium+3% Menthol|1% diclofenac sodium+3% menthol gel was supplied in 30 gram (g) tubes sufficient for each participants to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77319|NCT02100670|O4|Outcome|Placebo|Placebo with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77320|NCT02100670|O3|Outcome|3% Menthol|3% menthol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77321|NCT02100670|O2|Outcome|1% Diclofenac Sodium|1% diclofenac sodium with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77322|NCT02100670|O1|Outcome|1% Diclofenac Sodium+3% Menthol|1% diclofenac sodium+3% menthol gel was supplied in 30 gram (g) tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77323|NCT02100670|O4|Outcome|Placebo|Placebo with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77324|NCT02100670|O3|Outcome|3% Menthol|3% menthol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77325|NCT02100670|O2|Outcome|1% Diclofenac Sodium|1% diclofenac sodium with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77326|NCT02100670|O1|Outcome|1% Diclofenac Sodium+3% Menthol|1% diclofenac sodium+3% menthol gel was supplied in 30 gram (g) tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77327|NCT02100670|O4|Outcome|Placebo|Placebo with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77328|NCT02100670|O3|Outcome|3% Menthol|3% menthol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77329|NCT02100670|O2|Outcome|1% Diclofenac Sodium|1% diclofenac sodium with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77330|NCT02100670|O1|Outcome|1% Diclofenac Sodium+3% Menthol|1% diclofenac sodium+3% menthol gel was supplied in 30 gram (g) tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77331|NCT02100670|O4|Outcome|Placebo|Placebo with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77332|NCT02100670|O3|Outcome|3% Menthol|3% menthol gel supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77333|NCT02100670|O2|Outcome|1% Diclofenac Sodium|1% diclofenac sodium with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77334|NCT02100670|O1|Outcome|1% Diclofenac Sodium+3% Menthol|1% diclofenac sodium+3% menthol gel was supplied in 30 gram (g) tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77335|NCT02100670|O4|Outcome|Placebo|Placebo with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77336|NCT02100670|O3|Outcome|3% Menthol|3% menthol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77337|NCT02100670|O2|Outcome|1% Diclofenac Sodium|1% diclofenac sodium with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77338|NCT02100670|O1|Outcome|1% Diclofenac Sodium+3% Menthol|1% diclofenac sodium+3% menthol gel was supplied in 30 gram (g) tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77339|NCT02100670|O4|Outcome|Placebo|Placebo with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77340|NCT02100670|O3|Outcome|3% Menthol|3% menthol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77341|NCT02100670|O2|Outcome|1% Diclofenac Sodium|1% diclofenac sodium with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77342|NCT02100670|O1|Outcome|1% Diclofenac Sodium+3% Menthol|1% diclofenac sodium+3% menthol gel was supplied in 30 gram (g) tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77343|NCT02100670|O2|Outcome|Placebo|Placebo gel was supplied in 30g tubes for each participant to apply 4g of gel topically to the injured ankle region four times daily for up to 10 days.
77344|NCT02100670|O1|Outcome|1% Diclofenac Sodium Plus (+) 3% Menthol|1% diclofenac sodium+3% menthol gel was supplied in 30 gram (g) tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77345|NCT02100670|E4|Reported Event|Placebo With 0.09% Menthol Gel|Placebo with 0.09% menthol gel supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77346|NCT02100670|E3|Reported Event|3% Menthol|3% menthol gel supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77347|NCT02100670|E2|Reported Event|1% Diclofenac Sodium Plus 0.09% Menthol|1% diclofenac sodium plus 0.09% menthol gel supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77348|NCT02100670|E1|Reported Event|1% Diclofenac Sodium Plus 3% Menthol|1% diclofenac sodium plus 3% menthol gel supplied in 30 gram (g) tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
77349|NCT02100644|B1|Baseline|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk
77350|NCT02100644|P3|Participant Flow|Maintenance Phase: LTG Plus VPA|Participants received two different treatments. In one group, participants received a fixed maintenance dose of LTG 200 mg/d (or 100 to 200 mg/d if there were safety concerns during the LTG Escalation Phase) and VPA 100 mg/d (or higher if seizures occurred during the VPA Reduction Phase) were administered twice and 1-3 times daily, respectively, for 12 weeks. The frequency of administration was not changed. If seizures occurred, VPA dose could be increased/re-introduced. On the other group, after VPA was withdrawn, LTG dose was escalated up to 300 mg/d with 50-100 mg increment per 1-2 weeks. If there was safety concern or if remaining dose to 300 mg/d was below 50 mg, 25 mg increment was also available. If seizures occurred, LTG dose was increased up to 400 mg/d. If there was safety concern, LTG dose was decreased to 100 mg/d. If there was still safety concern at 100 mg/d, the participants were discontinued from the study. The total duration of this phase was 12 weeks.
77383|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77351|NCT02100644|P2|Participant Flow|Reduction Phase: LTG Plus VPA|Participants received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was determined at the discretion of the investigator or sub-investigator: e.g., 1000 mg/d (2 weeks), 800 mg/d (2 weeks), 600 mg/d (2 weeks), 400 mg/d (2 weeks), 300 mg/d OR 1000 mg/d (4 weeks), 600 mg/d (4 weeks), 300 mg/d and when VPA was reduced to less than 300 mg/d, the dose was reduced to 300, 200, 100, and 0 mg/d in 100 mg decrements in steps of at least one week duration. When VPA was concomitantly used, LTG was administered twice daily with 200 mg/d as a maintenance dose. If there were safety concerns during the LTG Escalation Phase, a fixed maintenance dose of 100 to 200 mg/d of LTG was administered twice daily. When VPA was withdrawn (that is, VPA was reduced to 0 mg/d), LTG was required to be increased by 50-100 mg/d. If there were any safety concern, 25 mg increment was also available. The total duration of this phase was 4 to16 weeks.
77352|NCT02100644|P1|Participant Flow|Escalation Phase: LTG Plus VPA|Participants received a fixed maintenance dose of VPA (400-1200 mg/d) along with lamotrigine (LTG) which was gradually escalated to 200 mg/d in accordance with the information of package insert: i.e. 25 mg of LTG was orally administered once every other day for the first 2 weeks and then once daily for the following 2 weeks. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 weeks for once or twice daily administration. If there were safety concerns, the LTG dose was decreased to 100 mg/d at the discretion of the investigator or sub-investigator. If there were still safety concerns despite the dose reduction to 100 mg/d, LTG was discontinued. The total duration of this phase was 8 to18 weeks.
77353|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
77354|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
77355|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
77356|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
77357|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
77384|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77385|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77386|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77358|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
77359|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
77360|NCT02100644|E1|Reported Event|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to &lt; 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
77361|NCT02100579|B3|Baseline|Total|Total of all reporting groups
77362|NCT02100579|B2|Baseline|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline~Preservative free normal saline: 10 ml of preservative free normal saline"
77363|NCT02100579|B1|Baseline|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine~Bupivacaine: 10 ml of 0.25% bupivacaine"
77364|NCT02100579|P2|Participant Flow|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline~Preservative free normal saline: 10 ml of preservative free normal saline"
77365|NCT02100579|P1|Participant Flow|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine~Bupivacaine: 10 ml of 0.25% bupivacaine"
77366|NCT02100579|O2|Outcome|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline~Preservative free normal saline: 10 ml of preservative free normal saline"
77367|NCT02100579|O1|Outcome|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine~Bupivacaine: 10 ml of 0.25% bupivacaine"
77368|NCT02100579|O2|Outcome|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline~Preservative free normal saline: 10 ml of preservative free normal saline"
77369|NCT02100579|O1|Outcome|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine~Bupivacaine: 10 ml of 0.25% bupivacaine"
77370|NCT02100579|O2|Outcome|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline~Preservative free normal saline: 10 ml of preservative free normal saline"
77371|NCT02100579|O1|Outcome|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine~Bupivacaine: 10 ml of 0.25% bupivacaine"
77372|NCT02100579|E2|Reported Event|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline~Preservative free normal saline: 10 ml of preservative free normal saline"
77373|NCT02100579|E1|Reported Event|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine~Bupivacaine: 10 ml of 0.25% bupivacaine"
77374|NCT02100514|B3|Baseline|Total|Total of all reporting groups
77375|NCT02100514|B2|Baseline|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77376|NCT02100514|B1|Baseline|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77377|NCT02100514|P2|Participant Flow|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77378|NCT02100514|P1|Participant Flow|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77379|NCT02100514|O1|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77380|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77381|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77382|NCT02100514|O1|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
79045|NCT02092961|O3|Outcome|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
77387|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77388|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77389|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77390|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77391|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77392|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77393|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77394|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77395|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77396|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77397|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77398|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77399|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77400|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77401|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77402|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77403|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77404|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77405|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77406|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77407|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77408|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77409|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77410|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77411|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77412|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77413|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77414|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77415|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77416|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77417|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77418|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
79046|NCT02092961|O2|Outcome|ADALIMUMAB 40 MG SC|Dosing Group D
77419|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77420|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77421|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77422|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77423|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77424|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77425|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77426|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77427|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77428|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77429|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77430|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77431|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77432|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77433|NCT02100514|E2|Reported Event|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77434|NCT02100514|E1|Reported Event|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
77435|NCT02100475|B3|Baseline|Total|Total of all reporting groups
77436|NCT02100475|B2|Baseline|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
77437|NCT02100475|B1|Baseline|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
77438|NCT02100475|P2|Participant Flow|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
77439|NCT02100475|P1|Participant Flow|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
77440|NCT02100475|O2|Outcome|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
77441|NCT02100475|O1|Outcome|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
77474|NCT02100280|O2|Outcome|Moderate Block|Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.
79047|NCT02092961|O1|Outcome|FOSTA 100 MG PO BID|Dosing Group A
77442|NCT02100475|O2|Outcome|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
77443|NCT02100475|O1|Outcome|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
77444|NCT02100475|O2|Outcome|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
77445|NCT02100475|O1|Outcome|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
77446|NCT02100475|E2|Reported Event|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
77447|NCT02100475|E1|Reported Event|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
77448|NCT02100410|B1|Baseline|Overall|All treatment sequences
77449|NCT02100410|P6|Participant Flow|Sequence 6|T5 and T6; T3 and T4; T1 and T2
77450|NCT02100410|P5|Participant Flow|Sequence 5|T5 and T6; T1 and T2; T3 and T4
77451|NCT02100410|P4|Participant Flow|Sequence 4|T3 and T4; T5 and T6; T1 and T2
77452|NCT02100410|P3|Participant Flow|Sequence 3|T3 and T4; T1 and T2; T5 and T6
77453|NCT02100410|P2|Participant Flow|Sequence 2|T1 and T2; T5 and T6; T3 and T4
77454|NCT02100410|P1|Participant Flow|Sequence 1|T1 and T2; T3 and T4; T5 and T6
77455|NCT02100410|O3|Outcome|TEST5|Iteration 2-87-3 with embossed mark
77456|NCT02100410|O2|Outcome|TEST3|Iteration 2-87-2 with embossed mark
77457|NCT02100410|O1|Outcome|TEST1|Iteration 2-87-1 with embossed mark
77458|NCT02100410|O6|Outcome|TEST6|Iteration 2-87-3 without embossed mark
77459|NCT02100410|O5|Outcome|TEST5|Iteration 2-87-3 with embossed mark
77460|NCT02100410|O4|Outcome|TEST4|Iteration 2-87-2 without embossed mark
77461|NCT02100410|O3|Outcome|TEST3|Iteration 2-87-2 with embossed mark
77462|NCT02100410|O2|Outcome|TEST2|Iteration 2-87-1 without embossed mark
77463|NCT02100410|O1|Outcome|TEST1|Iteration 2-87-1 with embossed mark
77464|NCT02100410|O3|Outcome|TEST5|Iteration 2-87-3 with embossed mark
77465|NCT02100410|O2|Outcome|TEST3|Iteration 2-87-2 with embossed mark
77466|NCT02100410|O1|Outcome|TEST1|Iteration 2-87-1 with embossed mark
77467|NCT02100410|E2|Reported Event|TEST (2,4,6)|Delefilcon A toric contact lenses without embossed mark, 3 different iterations, crossover all on the same eye
77468|NCT02100410|E1|Reported Event|TEST (1,3,5)|Delefilcon A toric contact lenses with embossed mark, 3 different iterations, crossover all on the same eye
77469|NCT02100280|B3|Baseline|Total|Total of all reporting groups
77470|NCT02100280|B2|Baseline|Moderate Block|After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.
77471|NCT02100280|B1|Baseline|Deep Block|"After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block.~deep block: sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block"
77472|NCT02100280|P2|Participant Flow|Moderate Block|Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.
77473|NCT02100280|P1|Participant Flow|Deep Block|Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block.
77475|NCT02100280|O1|Outcome|Deep Block|Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block.
77476|NCT02100280|O2|Outcome|Moderate Block|Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.
77477|NCT02100280|O1|Outcome|Deep Block|Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block.
77478|NCT02100280|O2|Outcome|Moderate Block|Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.
77479|NCT02100280|O1|Outcome|Deep Block|Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block.
77480|NCT02100280|O2|Outcome|Moderate Block|Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.
77481|NCT02100280|O1|Outcome|Deep Block|Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block.
77482|NCT02100280|O2|Outcome|Moderate Block|After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.
77483|NCT02100280|O1|Outcome|Deep Block|"After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block.~deep block: sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block"
77484|NCT02100280|E2|Reported Event|Moderate Block|After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.
77485|NCT02100280|E1|Reported Event|Deep Block|"After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block.~deep block: sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block"
77486|NCT02100228|B3|Baseline|Total|Total of all reporting groups
77487|NCT02100228|B2|Baseline|Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)|Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant’s sensitivity to the drug according to the investigators usual practice.
77488|NCT02100228|B1|Baseline|Apixaban|Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator’s judgement as per local label for the prevention of stroke and systemic embolism in participants.
77489|NCT02100228|P2|Participant Flow|Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)|Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant’s sensitivity to the drug according to the investigators usual practice.
77490|NCT02100228|P1|Participant Flow|Apixaban|Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator’s judgement as per local label for the prevention of stroke and systemic embolism in participants.
77491|NCT02100228|O2|Outcome|Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)|Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant’s sensitivity to the drug according to the investigators usual practice.
77597|NCT02099461|O1|Outcome|No Treatment|Participants received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
79048|NCT02092961|E4|Reported Event|PLACEBO (6 WKS) THEN FOSTA 100 MG BID - Placebo Period|
77492|NCT02100228|O1|Outcome|Apixaban|Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator’s judgement as per local label for the prevention of stroke and systemic embolism in participants.
77493|NCT02100228|O2|Outcome|Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)|Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant’s sensitivity to the drug according to the investigators usual practice.
77494|NCT02100228|O1|Outcome|Apixaban|Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator’s judgement as per local label for the prevention of stroke and systemic embolism in participants.
77495|NCT02100228|O2|Outcome|Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)|Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant’s sensitivity to the drug according to the investigators usual practice.
77496|NCT02100228|O1|Outcome|Apixaban|Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator’s judgement as per local label for the prevention of stroke and systemic embolism in participants.
77497|NCT02100228|O2|Outcome|Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)|Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant’s sensitivity to the drug according to the investigators usual practice.
77498|NCT02100228|O1|Outcome|Apixaban|Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator’s judgement as per local label for the prevention of stroke and systemic embolism in participants.
77499|NCT02100228|O2|Outcome|Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)|Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant’s sensitivity to the drug according to the investigators usual practice.
77500|NCT02100228|O1|Outcome|Apixaban|Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator’s judgement as per local label for the prevention of stroke and systemic embolism in participants.
77501|NCT02100228|O2|Outcome|Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)|Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant’s sensitivity to the drug according to the investigators usual practice.
77502|NCT02100228|O1|Outcome|Apixaban|Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator’s judgement as per local label for the prevention of stroke and systemic embolism in participants.
77503|NCT02100228|O2|Outcome|Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)|Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant’s sensitivity to the drug according to the investigators usual practice.
77504|NCT02100228|O1|Outcome|Apixaban|Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator’s judgement as per local label for the prevention of stroke and systemic embolism in participants.
77505|NCT02100228|O2|Outcome|Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)|Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant’s sensitivity to the drug according to the investigators usual practice.
77506|NCT02100228|O1|Outcome|Apixaban|Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator’s judgement as per local label for the prevention of stroke and systemic embolism in participants.
77507|NCT02100228|O2|Outcome|Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)|Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant’s sensitivity to the drug according to the investigators usual practice.
77598|NCT02099461|E3|Reported Event|Treatment C 120 MG SC|Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
77508|NCT02100228|O1|Outcome|Apixaban|Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator’s judgement as per local label for the prevention of stroke and systemic embolism in participants.
77509|NCT02100228|O2|Outcome|Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)|Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant’s sensitivity to the drug according to the investigators usual practice.
77510|NCT02100228|O1|Outcome|Apixaban|Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator’s judgement as per local label for the prevention of stroke and systemic embolism in participants.
77511|NCT02100228|O2|Outcome|Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)|Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant’s sensitivity to the drug according to the investigators usual practice.
77512|NCT02100228|O1|Outcome|Apixaban|Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator’s judgement as per local label for the prevention of stroke and systemic embolism in participants.
77513|NCT02100228|E2|Reported Event|Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)|Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant’s sensitivity to the drug according to the investigators usual practice.
77514|NCT02100228|E1|Reported Event|Apixaban|Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator’s judgement as per local label for the prevention of stroke and systemic embolism in participants.
77515|NCT02100189|B1|Baseline|Esophageal Cell Harvesting Procedure|Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.
77516|NCT02100189|P1|Participant Flow|Esophageal Cell Harvesting Procedure|Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.
77517|NCT02100189|O1|Outcome|Esophageal Cell Harvesting Procedure|Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.
77518|NCT02100189|O1|Outcome|Esophageal Cell Harvesting Procedure|Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.
77519|NCT02100189|O1|Outcome|Esophageal Cell Harvesting Procedure|Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.
77520|NCT02100189|O1|Outcome|Esophageal Cell Harvesting Procedure|Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.
77521|NCT02100189|E1|Reported Event|Esophageal Cell Harvesting Procedure|Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.
77522|NCT02100007|B1|Baseline|ME-344|"ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle~ME-344: Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle.~Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle.~Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator.~Topotecan: Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.~Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle."
77523|NCT02100007|P1|Participant Flow|ME-344|"ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle~ME-344: Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle.~Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle.~Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator.~Topotecan: Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.~Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle."
77538|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
77524|NCT02100007|O1|Outcome|ME-344|"ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle~ME-344: Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle.~Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle.~Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator.~Topotecan: Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.~Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle."
77525|NCT02100007|O1|Outcome|ME-344|"ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle~ME-344: Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle.~Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle.~Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator.~Topotecan: Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.~Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle."
77526|NCT02100007|O1|Outcome|ME-344|"ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle~ME-344: Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle.~Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle.~Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator.~Topotecan: Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.~Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle."
77527|NCT02100007|O1|Outcome|ME-344|"ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle~ME-344: Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle.~Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle.~Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator.~Topotecan: Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.~Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle."
77528|NCT02100007|O1|Outcome|ME-344|"ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle~ME-344: Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle.~Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle.~Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator.~Topotecan: Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.~Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle."
77529|NCT02100007|O1|Outcome|ME-344|"ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle~ME-344: Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle.~Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle.~Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator.~Topotecan: Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.~Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle."
77530|NCT02100007|O1|Outcome|ME-344|ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle ...
77531|NCT02100007|O1|Outcome|ME-344|"ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle~ME-344: Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle.~Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle.~Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator.~Topotecan: Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.~Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle."
77532|NCT02100007|E1|Reported Event|ME-344|"ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle~ME-344: Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle.~Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle.~Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator.~Topotecan: Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.~Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle."
77533|NCT02099838|B3|Baseline|Total|Total of all reporting groups
77534|NCT02099838|B2|Baseline|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
77535|NCT02099838|B1|Baseline|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
77536|NCT02099838|P2|Participant Flow|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
77537|NCT02099838|P1|Participant Flow|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
77595|NCT02099461|O3|Outcome|Denosumab 120 mg|Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
77539|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
77540|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
77541|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
77542|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
77543|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
77544|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
77545|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
77546|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
77547|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
77548|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
77549|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
77550|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
77551|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
77552|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
77553|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
77554|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
77555|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
77556|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
77557|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
77596|NCT02099461|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
77558|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
77559|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
77560|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
77561|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
77562|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
77563|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
77564|NCT02099838|E2|Reported Event|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
77565|NCT02099838|E1|Reported Event|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
77566|NCT02099708|B1|Baseline|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
77567|NCT02099708|P1|Participant Flow|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
77568|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
77569|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
77570|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
77571|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
77572|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
77573|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
77574|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
77575|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
77576|NCT02099708|E1|Reported Event|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
77577|NCT02099682|B1|Baseline|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
77578|NCT02099682|P1|Participant Flow|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
77579|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
77580|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
77581|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
77582|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
77583|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
77584|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
77585|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
77586|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
77587|NCT02099682|E1|Reported Event|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
77588|NCT02099461|B4|Baseline|Total|Total of all reporting groups
77589|NCT02099461|B3|Baseline|Denosumab 120 mg|Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
77590|NCT02099461|B2|Baseline|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
77591|NCT02099461|B1|Baseline|No Treatment|Participants received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
77592|NCT02099461|P3|Participant Flow|Denosumab 120 mg|Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
77593|NCT02099461|P2|Participant Flow|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
77594|NCT02099461|P1|Participant Flow|No Treatment|Participants received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
77599|NCT02099461|E2|Reported Event|Treatment B 60 MG SC|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
77600|NCT02099461|E1|Reported Event|Treatment A No Treatment|Participants in this group received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
77601|NCT02099344|B3|Baseline|Total|Total of all reporting groups
77602|NCT02099344|B2|Baseline|Artegraft|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
77603|NCT02099344|B1|Baseline|Propaten|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
77604|NCT02099344|P2|Participant Flow|Artegraft|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
77605|NCT02099344|P1|Participant Flow|Propaten|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
77606|NCT02099344|O2|Outcome|Artegraft|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
77607|NCT02099344|O1|Outcome|Propaten|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
77608|NCT02099344|E2|Reported Event|Artegraft|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
77609|NCT02099344|E1|Reported Event|Propaten|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
77610|NCT02099318|B3|Baseline|Total|Total of all reporting groups
77611|NCT02099318|B2|Baseline|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.~Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
77612|NCT02099318|B1|Baseline|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct the model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during surgery for evaluation of optional surgery approaches.~Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches.~Inclusion criteria:~Patient age >=18 years old with unruptured or ruptured cerebral aneurysm in the anterior circulation f"
77613|NCT02099318|P2|Participant Flow|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.~Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
77614|NCT02099318|P1|Participant Flow|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during the surgery for evaluation of optional surgery approaches.~Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches."
77615|NCT02099318|O2|Outcome|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.~Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
77668|NCT02099110|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, oral, once daily for 52 weeks
77669|NCT02099110|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, oral, once daily for 52 weeks
77616|NCT02099318|O1|Outcome|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during the surgery for evaluation of optional surgery approaches.~Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches."
77617|NCT02099318|O2|Outcome|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.~Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
77618|NCT02099318|O1|Outcome|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during the surgery for evaluation of optional surgery approaches.~Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches."
77619|NCT02099318|O2|Outcome|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.~Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
77620|NCT02099318|O1|Outcome|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during the surgery for evaluation of optional surgery approaches.~Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches."
77621|NCT02099318|O2|Outcome|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.~Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
77622|NCT02099318|O1|Outcome|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct the model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during the surgery for evaluation of optional surgery approaches.~Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches."
77623|NCT02099318|O2|Outcome|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.~Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
77624|NCT02099318|O1|Outcome|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct the model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during surgery for evaluation of optional surgery approaches.~Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches.~Inclusion criteria:~Patient age >=18 years old with unruptured or ruptured cerebral aneurysm in the anterior circulation f"
77625|NCT02099318|E2|Reported Event|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.~Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
77670|NCT02099110|O5|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
77626|NCT02099318|E1|Reported Event|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct the model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, SRP will be available for the surgeons during the surgery for evaluation of optional surgery approaches.~Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during surgery for evaluation of optional surgical approaches.~Inclusion criteria:~Patient age >=18 years old with unruptured or ruptured cerebral aneurysm in the anterior circulation for w"
77627|NCT02099266|B1|Baseline|Hyperbaric Oxygen Treatment|"Administration of hyperbaric oxygen the morning of UCB transplant.~Administration of hyperbaric oxygen: Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours"
77628|NCT02099266|P1|Participant Flow|Hyperbaric Oxygen Treatment|"Administration of hyperbaric oxygen the morning of UCB transplant.~Administration of hyperbaric oxygen: Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours"
77629|NCT02099266|O1|Outcome|Reduced-Intensity Conditioning|
77630|NCT02099266|O2|Outcome|Myeloablative Conditioning|"Myeloablative transplant patients will receive the following chemotherapeutic agents and radiation on the respective days:~Day -10, -9, and -8: Fludarabine (25 mg/m2 IV) IV Day -7, -6, -5, and -4: Total body irradiation 165 cGy twice daily Day -3 and -2: Cyclophosphamide (60 mg/kg/day ) and mesna 50mg/kg/day (milligrams per kilogram per day) IV"
77631|NCT02099266|O1|Outcome|Reduced-Intensity Conditioning|"Reduced-Intensity (also referred to as: Non‐myeloablative) transplant patients will receive the following chemotherapeutic agents and radiation on the respective days:~Day -6 : fludarabine 40mg/m2 (milligram per meter squared) intravenously (IV), cyclophosphamide 50mg/kg IV, and mesna 50mg/kg IV Day-5 to -2: fludarabine 40mg/m2 intravenously (IV) Day -1: Total body irradiation (TBI) 200 centrigray (cGy)"
77632|NCT02099266|O1|Outcome|Hyperbaric Oxygen Treatment|"Administration of hyperbaric oxygen the morning of UCB transplant.~Administration of hyperbaric oxygen: Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours"
77633|NCT02099266|E1|Reported Event|Hyperbaric Oxygen Treatment|"Administration of hyperbaric oxygen the morning of UCB transplant.~Administration of hyperbaric oxygen: Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours"
77634|NCT02099110|B6|Baseline|Total|Total of all reporting groups
77635|NCT02099110|B5|Baseline|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
77636|NCT02099110|B4|Baseline|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
77637|NCT02099110|B3|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg, oral, once daily for 52 weeks
77638|NCT02099110|B2|Baseline|Ertugliflozin 15 mg|Ertugliflozin, oral, once daily for 52 weeks
77639|NCT02099110|B1|Baseline|Ertugliflozin 5 mg|Ertugliflozin 5 mg, oral, once daily for 52 weeks
77640|NCT02099110|P5|Participant Flow|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
77641|NCT02099110|P4|Participant Flow|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
77642|NCT02099110|P3|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg, oral, once daily for 52 weeks
77643|NCT02099110|P2|Participant Flow|Ertugliflozin 15 mg|Ertugliflozin, oral, once daily for 52 weeks
77644|NCT02099110|P1|Participant Flow|Ertugliflozin 5 mg|Ertugliflozin 5 mg, oral, once daily for 52 weeks
77645|NCT02099110|O5|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
77646|NCT02099110|O4|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
77647|NCT02099110|O3|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, oral, once daily for 52 weeks
77648|NCT02099110|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, oral, once daily for 52 weeks
77649|NCT02099110|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, oral, once daily for 52 weeks
77650|NCT02099110|O5|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
77651|NCT02099110|O4|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
77652|NCT02099110|O3|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, oral, once daily for 52 weeks
77653|NCT02099110|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, oral, once daily for 52 weeks
77654|NCT02099110|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, oral, once daily for 52 weeks
77655|NCT02099110|O5|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
77656|NCT02099110|O4|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
77657|NCT02099110|O3|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, oral, once daily for 52 weeks
77658|NCT02099110|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, oral, once daily for 52 weeks
77659|NCT02099110|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, oral, once daily for 52 weeks
77660|NCT02099110|O5|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
77661|NCT02099110|O4|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
77662|NCT02099110|O3|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, oral, once daily for 52 weeks
77663|NCT02099110|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, oral, once daily for 52 weeks
77664|NCT02099110|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, oral, once daily for 52 weeks
77665|NCT02099110|O5|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
77666|NCT02099110|O4|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
77667|NCT02099110|O3|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, oral, once daily for 52 weeks
77671|NCT02099110|O4|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
77672|NCT02099110|O3|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, oral, once daily for 52 weeks
77673|NCT02099110|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, oral, once daily for 52 weeks
77674|NCT02099110|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, oral, once daily for 52 weeks
77675|NCT02099110|O5|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
77676|NCT02099110|O4|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
77677|NCT02099110|O3|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, oral, once daily for 52 weeks
77678|NCT02099110|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, oral, once daily for 52 weeks
77679|NCT02099110|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, oral, once daily for 52 weeks
77680|NCT02099110|O5|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
77681|NCT02099110|O4|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
77682|NCT02099110|O3|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, oral, once daily for 52 weeks
77683|NCT02099110|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, oral, once daily for 52 weeks
77684|NCT02099110|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, oral, once daily for 52 weeks
77685|NCT02099110|E5|Reported Event|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
77686|NCT02099110|E4|Reported Event|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
77687|NCT02099110|E3|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg, oral, once daily for 52 weeks
77688|NCT02099110|E2|Reported Event|Ertugliflozin 15 mg|Ertugliflozin, oral, once daily for 52 weeks
77689|NCT02099110|E1|Reported Event|Ertugliflozin 5 mg|Ertugliflozin 5 mg, oral, once daily for 52 weeks
77690|NCT02099084|B1|Baseline|Entire Study Population|Includes groups randomized to receive placebo first and Teduglutide first.
77691|NCT02099084|P2|Participant Flow|Placebo First, Then Teduglutide|Placebo administered subcutaneously for 7 days, followed by a 14-day washout period, and Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days.
77692|NCT02099084|P1|Participant Flow|Teduglutide First, Then Placebo|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days, followed by a 14-day washout period, and placebo administered subcutaneously for 7 days.
77693|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
77694|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
77695|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
77696|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
77697|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
77698|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
77699|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
77700|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
77701|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
77702|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
77703|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
77704|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
77705|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
77706|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
77707|NCT02099084|E2|Reported Event|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
77708|NCT02099084|E1|Reported Event|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
77709|NCT02099006|B1|Baseline|All Study Participants|"Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.~Amitriptyline/ Baclofen: Topical application of the drug at a 2% concentration in combination with 2% Baclofen~Ketoprofen: To be applied topically at a 10% concentration~Ketamine: To be applied topically at a 10% concentration~Loperamide: To be applied topically at a 5% concentration~Gabapentin: To be applied topically at a 6% concentration"
77710|NCT02099006|P1|Participant Flow|All Study Participants|"Each study subject was sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.~Amitriptyline 2%/ Baclofen 2%: Topical application of the drug at a 2% concentration in combination with 2% Baclofen~Ketoprofen: To be applied topically at a 10% concentration~Ketamine: To be applied topically at a 10% concentration~Loperamide: To be applied topically at a 5% concentration~Gabapentin: To be applied topically at a 6% concentration"
77711|NCT02099006|O2|Outcome|Placebo|"The compounding base alone will be used as a placebo. Each participant will be given each drug and the placebo sequentially in random order.~placebo: Compounding base to be used alone as a placebo"
79049|NCT02092961|E3|Reported Event|PLACEBO (6 WKS) THEN FOSTA 100 MG BID - FOSTA Period|
77712|NCT02099006|O1|Outcome|Medications|"Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.~Amitriptyline: Topical application of the drug at a 2% concentration in combination with 2% Baclofen~Baclofen: Used topically at 2% concentration in combination with 2% amitriptyline~Ketoprofen: To be applied topically at a 10% concentration~Ketamine: To be applied topically at a 10% concentration~Loperamide: To be applied topically at a 5% concentration~Gabapentin: To be applied topically at a 6% concentration"
77713|NCT02099006|O2|Outcome|Placebo|"The compounding base alone will be used as a placebo. Each participant will be given each drug and the placebo sequentially in random order.~placebo: Compounding base to be used alone as a placebo"
77714|NCT02099006|O1|Outcome|Medications|"Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.~Amitriptyline: Topical application of the drug at a 2% concentration in combination with 2% Baclofen~Baclofen: Used topically at 2% concentration in combination with 2% amitriptyline~Ketoprofen: To be applied topically at a 10% concentration~Ketamine: To be applied topically at a 10% concentration~Loperamide: To be applied topically at a 5% concentration~Gabapentin: To be applied topically at a 6% concentration"
77715|NCT02099006|E2|Reported Event|Placebo|"The compounding base alone will be used as a placebo. Each participant will be given each drug and the placebo sequentially in random order.~placebo: Compounding base to be used alone as a placebo"
77716|NCT02099006|E1|Reported Event|Medications|"Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.~Amitriptyline: Topical application of the drug at a 2% concentration in combination with 2% Baclofen~Baclofen: Used topically at 2% concentration in combination with 2% amitriptyline~Ketoprofen: To be applied topically at a 10% concentration~Ketamine: To be applied topically at a 10% concentration~Loperamide: To be applied topically at a 5% concentration~Gabapentin: To be applied topically at a 6% concentration"
77717|NCT02098746|B1|Baseline|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
77718|NCT02098746|P1|Participant Flow|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
77719|NCT02098746|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
77720|NCT02098746|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
77721|NCT02098746|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
77722|NCT02098746|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
77723|NCT02098746|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
77724|NCT02098746|E1|Reported Event|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
77725|NCT02098733|B1|Baseline|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
77726|NCT02098733|P1|Participant Flow|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
77727|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
77728|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
77729|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
77730|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
77731|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
77732|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
77733|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
77734|NCT02098733|E1|Reported Event|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
77735|NCT02098395|B5|Baseline|Total|Total of all reporting groups
77736|NCT02098395|B4|Baseline|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.~Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.~Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.~Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
77737|NCT02098395|B3|Baseline|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
77738|NCT02098395|B2|Baseline|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
77739|NCT02098395|B1|Baseline|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
77740|NCT02098395|P4|Participant Flow|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.~Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.~Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.~Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
79050|NCT02092961|E2|Reported Event|FOSTA 100 MG BID|Dosing Group A
77741|NCT02098395|P3|Participant Flow|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
77742|NCT02098395|P2|Participant Flow|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
77743|NCT02098395|P1|Participant Flow|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
77744|NCT02098395|O4|Outcome|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.~Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.~Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.~Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
77745|NCT02098395|O3|Outcome|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
77746|NCT02098395|O2|Outcome|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
77747|NCT02098395|O1|Outcome|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
77748|NCT02098395|O4|Outcome|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.~Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.~Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.~Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
77749|NCT02098395|O3|Outcome|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
77750|NCT02098395|O2|Outcome|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
77751|NCT02098395|O1|Outcome|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
77752|NCT02098395|O4|Outcome|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.~Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.~Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.~Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
77753|NCT02098395|O3|Outcome|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
77754|NCT02098395|O2|Outcome|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
77755|NCT02098395|O1|Outcome|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
77756|NCT02098395|E4|Reported Event|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.~Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.~Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.~Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
77757|NCT02098395|E3|Reported Event|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
77758|NCT02098395|E2|Reported Event|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
77759|NCT02098395|E1|Reported Event|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
77760|NCT02098304|B1|Baseline|Sound and Unsound Molars|"Imaging of unrestored sound molars (ICDAS 0) and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging Device~Calcivis Caries Activity Imaging System: Unrestored sound molars and unsound molars imaged with the Calcivis Caries Activity Imaging System"
77761|NCT02098304|P1|Participant Flow|Sound and Unsound Molars|Imaging of unrestored sound molars (ICDAS 0) and third molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System
77762|NCT02098304|O1|Outcome|Sound and Unsound Molars|"Imaging of unrestored sound molars (ICDAS 0), and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System~Calcivis Caries Activity Imaging System: Teeth imaged with the Calcivis Caries Activity Imaging System"
77763|NCT02098304|O1|Outcome|Sound and Unsound Molars|Imaging of unrestored sound molars (ICDAS 0) and third molars (ICDAS 1, 2 or 3) with the Calcivis Caries Activity Imaging System
77764|NCT02098304|O1|Outcome|Sound and Unsound Molars|"Imaging of unrestored sound molars (ICDAS 0) and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System~Calcivis Caries Activity Imaging System: Unrestored sound molars and third molars imaged with the Calcivis Caries Activity Imaging System"
77765|NCT02098304|O1|Outcome|Sound and Unsound Molars|Imaging of unrestored sound molars (ICDAS 0) and third molars (ICDAS 1, 2 or 3) with the Calcivis Caries Activity Imaging System
77766|NCT02098304|E1|Reported Event|Sound and Unsound Molars|"Imaging of unrestored sound molars (ICDAS 0) and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System~Calcivis Caries Activity Imaging System: Unrestored sound molars and third molars imaged with the Calcivis Caries Activity Imaging System"
77767|NCT02098109|B3|Baseline|Total|Total of all reporting groups
77768|NCT02098109|B2|Baseline|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
77769|NCT02098109|B1|Baseline|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
77770|NCT02098109|P2|Participant Flow|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
77771|NCT02098109|P1|Participant Flow|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
77772|NCT02098109|O2|Outcome|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
77773|NCT02098109|O1|Outcome|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
77774|NCT02098109|O2|Outcome|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
77775|NCT02098109|O1|Outcome|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
77776|NCT02098109|O2|Outcome|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
77777|NCT02098109|O1|Outcome|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
77778|NCT02098109|O2|Outcome|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
77779|NCT02098109|O1|Outcome|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
77780|NCT02098109|O2|Outcome|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
77781|NCT02098109|O1|Outcome|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
77782|NCT02098109|O2|Outcome|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
77783|NCT02098109|O1|Outcome|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
77784|NCT02098109|O2|Outcome|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
77785|NCT02098109|O1|Outcome|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
77786|NCT02098109|O2|Outcome|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
77787|NCT02098109|O1|Outcome|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
77788|NCT02098109|O2|Outcome|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
77789|NCT02098109|O1|Outcome|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
77790|NCT02098109|E2|Reported Event|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
77791|NCT02098109|E1|Reported Event|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)~Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)~Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
77792|NCT02097992|B5|Baseline|Total|Total of all reporting groups
77793|NCT02097992|B4|Baseline|SD Roflumilast and MD Roflumilast Then MD Placebo|Participants will receive 500ug roflumilast (single dose) followed by a 4 week treatment with 500ug roflumilast daily, followed by a 4 week washout period, followed by a 4 week treatment with placebo daily
77794|NCT02097992|B3|Baseline|SD Roflumilast and MD Placebo Then MD Roflumilast.|Participants will receive 500ug roflumilast (single dose) followed by a 4 week treatment with placebo daily, followed by a 4 week washout period, followed by a 4 week treatment with 500ug roflumilast daily.
77795|NCT02097992|B2|Baseline|SD Placebo and MD Placebo Then MD Roflumilast|Participants will receive placebo (single dose) followed by a 4 week treatment with placebo daily, followed by a 4 week washout period, followed by a 4 week treatment with 500ug roflumilast daily.
77796|NCT02097992|B1|Baseline|SD Placebo and MD Roflumilast Then MD Placebo|Participants will receive placebo (single dose) followed by a 4 week treatment with 500ug roflumilast daily, followed by a 4 week washout period, followed by a 4 week treatment with placebo daily.
77797|NCT02097992|P4|Participant Flow|SD Roflumilast and MD Roflumilast Then MD Placebo|Participants will receive 500ug roflumilast (single dose) followed by a 4 week treatment with 500ug roflumilast daily, followed by a 4 week washout period, followed by a 4 week treatment with placebo daily
77798|NCT02097992|P3|Participant Flow|SD Roflumilast and MD Placebo Then MD Roflumilast.|Participants will receive 500ug roflumilast (single dose) followed by a 4 week treatment with placebo daily, followed by a 4 week washout period, followed by a 4 week treatment with 500ug roflumilast daily.
77799|NCT02097992|P2|Participant Flow|SD Placebo and MD Placebo Then MD Roflumilast|Participants will receive placebo (single dose) followed by a 4 week treatment with placebo daily, followed by a 4 week washout period, followed by a 4 week treatment with 500ug roflumilast daily.
77800|NCT02097992|P1|Participant Flow|SD Placebo and MD Roflumilast Then MD Placebo|Participants will receive placebo (single dose) followed by a 4 week treatment with 500ug roflumilast daily, followed by a 4 week washout period, followed by a 4 week treatment with placebo daily.
77801|NCT02097992|O2|Outcome|Acute Roflumilast or Placebo|Treatment with a single dose of 500ug roflumilast or placebo
77802|NCT02097992|O1|Outcome|Long Term Multidose Roflumilast or Placebo|Treatment with 500ug roflumilast or placebo for 4 weeks
77803|NCT02097992|E4|Reported Event|Multi-dose Placebo|Participants received a daily Placebo dose for four weeks
77804|NCT02097992|E3|Reported Event|Multi-dose Roflumiast|Participants received a daily dose of 500Ug of Roflumilast for four weeks.
77805|NCT02097992|E2|Reported Event|Single Dose Placebo|Participants received a single dose Placebo for one day.
77806|NCT02097992|E1|Reported Event|Single Dose Roflumilast|Participants received a single dose of 500Ug of Roflumilast for one day.
77807|NCT02097849|B3|Baseline|Total|Total of all reporting groups
77808|NCT02097849|B2|Baseline|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77809|NCT02097849|B1|Baseline|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77810|NCT02097849|P2|Participant Flow|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77811|NCT02097849|P1|Participant Flow|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77812|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77813|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77814|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77815|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77816|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77817|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77818|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77819|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77820|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77821|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77822|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77823|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77824|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77825|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77826|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77827|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77828|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77829|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77830|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77831|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77832|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77833|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77834|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77835|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77836|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
78024|NCT02096900|P1|Participant Flow|Midazolam|midazolam was given at 0.5mg/kg, pre-operatively single dose
77837|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77838|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77839|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77840|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77841|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77842|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77843|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77844|NCT02097849|E2|Reported Event|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77845|NCT02097849|E1|Reported Event|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
77846|NCT02097823|B3|Baseline|Total|Total of all reporting groups
77847|NCT02097823|B2|Baseline|Olanzapine First, Aprepitant Second|"Will receive olanzapine (weight based dose, see below) in first cycle of chemotherapy and aprepitant (weight based dose, see below) in the second cycle of chemotherapy. All doses will be given starting 30 minutes before chemotherapy on day 1.~Olanzapine dosing:~>60kg - 10mg orally daily for 4 doses 40-59.9kg - 5mg orally daily for 4 doses 20-39.9kg - 2.5mg orally daily for 4 doses <20kg - 1.25mg orally daily for 4 doses~Aprepitant dosing:~>40kg - 125mg orally on day 1, then 80mg orally daily on days 2,3 35-39.9kg - 80mg orally daily for 3 doses 20-34.9kg - 40mg orally daily for 3 doses <20kg - 1.5-2mg/kg orally daily for 3 doses~Olanzapine~Aprepitant"
77848|NCT02097823|B1|Baseline|Aprepitant First, Olanzapine Second|"Will receive aprepitant (weight based dose, see below) in first cycle of chemotherapy and olanzapine (weight based dose, see below) in the second cycle of chemotherapy. All doses will be given starting 30 minutes before chemotherapy on day 1.~Olanzapine dosing:~>60kg - 10mg orally daily for 4 doses 40-59.9kg - 5mg orally daily for 4 doses 20-39.9kg - 2.5mg orally daily for 4 doses <20kg - 1.25mg orally daily for 4 doses~Aprepitant dosing:~>40kg - 125mg orally on day 1, then 80mg orally daily on days 2,3 35-39.9kg - 80mg orally daily for 3 doses 20-34.9kg - 40mg orally daily for 3 doses <20kg - 1.5-2mg/kg orally daily for 3 doses~Olanzapine~Aprepitant"
77849|NCT02097823|P2|Participant Flow|Olanzapine First, Aprepitant Second|"Will receive olanzapine (weight based dose, see below) in first cycle of chemotherapy and aprepitant (weight based dose, see below) in the second cycle of chemotherapy. All doses will be given starting 30 minutes before chemotherapy on day 1.~Olanzapine dosing:~>60kg - 10mg orally daily for 4 doses 40-59.9kg - 5mg orally daily for 4 doses 20-39.9kg - 2.5mg orally daily for 4 doses <20kg - 1.25mg orally daily for 4 doses~Aprepitant dosing:~>40kg - 125mg orally on day 1, then 80mg orally daily on days 2,3 35-39.9kg - 80mg orally daily for 3 doses 20-34.9kg - 40mg orally daily for 3 doses <20kg - 1.5-2mg/kg orally daily for 3 doses~Olanzapine~Aprepitant"
77850|NCT02097823|P1|Participant Flow|Aprepitant First, Olanzapine Second|"Will receive aprepitant (weight based dose, see below) in first cycle of chemotherapy and olanzapine (weight based dose, see below) in the second cycle of chemotherapy. All doses will be given starting 30 minutes before chemotherapy on day 1.~Olanzapine dosing:~>60kg - 10mg orally daily for 4 doses 40-59.9kg - 5mg orally daily for 4 doses 20-39.9kg - 2.5mg orally daily for 4 doses <20kg - 1.25mg orally daily for 4 doses~Aprepitant dosing:~>40kg - 125mg orally on day 1, then 80mg orally daily on days 2,3 35-39.9kg - 80mg orally daily for 3 doses 20-34.9kg - 40mg orally daily for 3 doses <20kg - 1.5-2mg/kg orally daily for 3 doses~Olanzapine~Aprepitant"
77851|NCT02097823|O2|Outcome|Olanzapine|Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
77852|NCT02097823|O1|Outcome|Aprepitant|Cycles where patients received aprepitant along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
77853|NCT02097823|O2|Outcome|Olanzapine|Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
77854|NCT02097823|O1|Outcome|Aprepitant|Cycles where patients received aprepitant along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
77855|NCT02097823|O2|Outcome|Olanzapine|Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
77856|NCT02097823|O1|Outcome|Aprepitant|Cycles where patients received aprepitant along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
77857|NCT02097823|O2|Outcome|Olanzapine|Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
77858|NCT02097823|O1|Outcome|Aprepitant|Cycles where patients received aprepitant along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
77859|NCT02097823|O2|Outcome|Olanzapine|Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
77860|NCT02097823|O1|Outcome|Aprepitant|Cycles where patients received aprepitant along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
77861|NCT02097823|O1|Outcome|All Participants|Both intervention arms included
77862|NCT02097823|E2|Reported Event|Olanzapine|Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
77863|NCT02097823|E1|Reported Event|Aprepitant|Cycles where patients received aprepitant along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
77864|NCT02097745|B1|Baseline|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
77865|NCT02097745|P1|Participant Flow|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
77866|NCT02097745|O2|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
77867|NCT02097745|O1|Outcome|Placebo|Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
77868|NCT02097745|O2|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
77869|NCT02097745|O1|Outcome|Placebo|Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
77870|NCT02097745|O2|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
77871|NCT02097745|O1|Outcome|Placebo|Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
77872|NCT02097745|O2|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
77873|NCT02097745|O1|Outcome|Placebo|Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
77874|NCT02097745|O2|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
77875|NCT02097745|O1|Outcome|Placebo|Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
77876|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
77877|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
77878|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
77879|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
77880|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
77881|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
77882|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
77883|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
77884|NCT02097745|E2|Reported Event|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
77885|NCT02097745|E1|Reported Event|Placebo|Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
77886|NCT02097732|B3|Baseline|Total|Total of all reporting groups
77887|NCT02097732|B2|Baseline|A: Induction|"Patients will receive 2 doses of ipilimumab, which is given once every 3 weeks, prior to stereotactic radiosurgery (SRS), followed by 2 more doses of ipilimumab, for a total of 4 doses.~Ipilimumab: Ipilimumab 3mg/kg given intravenously over 90 minutes, every 3 weeks for a total of 4 doses.~Stereotactic Radiosurgery: Stereotactic radiosurgery is a type of focused radiation therapy. It requires the placement of a metal frame on the head for several hours."
77888|NCT02097732|B1|Baseline|B: No Induction|"Participants will undergo stereotactic radiosurgery (SRS) followed 2-3 weeks later by ipilimumab, which is given once every 3 weeks for a total of 4 doses.~Ipilimumab: Ipilimumab 3mg/kg given intravenously over 90 minutes, every 3 weeks for a total of 4 doses.~Stereotactic Radiosurgery: Stereotactic radiosurgery is a type of focused radiation therapy. It requires the placement of a metal frame on the head for several hours."
77889|NCT02097732|P2|Participant Flow|A: Induction|"Patients will receive 2 doses of ipilimumab, which is given once every 3 weeks, prior to stereotactic radiosurgery (SRS), followed by 2 more doses of ipilimumab, for a total of 4 doses.~Ipilimumab: Ipilimumab 3mg/kg given intravenously over 90 minutes, every 3 weeks for a total of 4 doses.~Stereotactic Radiosurgery: Stereotactic radiosurgery is a type of focused radiation therapy. It requires the placement of a metal frame on the head for several hours."
77890|NCT02097732|P1|Participant Flow|B: No Induction|"Participants will undergo stereotactic radiosurgery (SRS) followed 2-3 weeks later by ipilimumab, which is given once every 3 weeks for a total of 4 doses.~Ipilimumab: Ipilimumab 3mg/kg given intravenously over 90 minutes, every 3 weeks for a total of 4 doses.~Stereotactic Radiosurgery: Stereotactic radiosurgery is a type of focused radiation therapy. It requires the placement of a metal frame on the head for several hours."
77891|NCT02097732|O2|Outcome|A: Induction|"Patients will receive 2 doses of ipilimumab, which is given once every 3 weeks, prior to stereotactic radiosurgery (SRS), followed by 2 more doses of ipilimumab, for a total of 4 doses.~Ipilimumab: Ipilimumab 3mg/kg given intravenously over 90 minutes, every 3 weeks for a total of 4 doses.~Stereotactic Radiosurgery: Stereotactic radiosurgery is a type of focused radiation therapy. It requires the placement of a metal frame on the head for several hours."
77892|NCT02097732|O1|Outcome|B: No Induction|"Participants will undergo stereotactic radiosurgery (SRS) followed 2-3 weeks later by ipilimumab, which is given once every 3 weeks for a total of 4 doses.~Ipilimumab: Ipilimumab 3mg/kg given intravenously over 90 minutes, every 3 weeks for a total of 4 doses.~Stereotactic Radiosurgery: Stereotactic radiosurgery is a type of focused radiation therapy. It requires the placement of a metal frame on the head for several hours."
77893|NCT02097732|O2|Outcome|A: Induction|"Patients will receive 2 doses of ipilimumab, which is given once every 3 weeks, prior to stereotactic radiosurgery (SRS), followed by 2 more doses of ipilimumab, for a total of 4 doses.~Ipilimumab: Ipilimumab 3mg/kg given intravenously over 90 minutes, every 3 weeks for a total of 4 doses.~Stereotactic Radiosurgery: Stereotactic radiosurgery is a type of focused radiation therapy. It requires the placement of a metal frame on the head for several hours."
77894|NCT02097732|O1|Outcome|B: No Induction|"Participants will undergo stereotactic radiosurgery (SRS) followed 2-3 weeks later by ipilimumab, which is given once every 3 weeks for a total of 4 doses.~Ipilimumab: Ipilimumab 3mg/kg given intravenously over 90 minutes, every 3 weeks for a total of 4 doses.~Stereotactic Radiosurgery: Stereotactic radiosurgery is a type of focused radiation therapy. It requires the placement of a metal frame on the head for several hours."
77895|NCT02097732|O2|Outcome|A: Induction|"Patients will receive 2 doses of ipilimumab, which is given once every 3 weeks, prior to stereotactic radiosurgery (SRS), followed by 2 more doses of ipilimumab, for a total of 4 doses.~Ipilimumab: Ipilimumab 3mg/kg given intravenously over 90 minutes, every 3 weeks for a total of 4 doses.~Stereotactic Radiosurgery: Stereotactic radiosurgery is a type of focused radiation therapy. It requires the placement of a metal frame on the head for several hours."
77896|NCT02097732|O1|Outcome|B: No Induction|"Participants will undergo stereotactic radiosurgery (SRS) followed 2-3 weeks later by ipilimumab, which is given once every 3 weeks for a total of 4 doses.~Ipilimumab: Ipilimumab 3mg/kg given intravenously over 90 minutes, every 3 weeks for a total of 4 doses.~Stereotactic Radiosurgery: Stereotactic radiosurgery is a type of focused radiation therapy. It requires the placement of a metal frame on the head for several hours."
77897|NCT02097732|E1|Reported Event|Ipilimumab and SRS|"(Induction) Patients will receive 2 doses of ipilimumab, which is given once every 3 weeks, prior to stereotactic radiosurgery (SRS), followed by 2 more doses of ipilimumab, for a total of 4 doses.~OR~(No Induction) Participants will undergo stereotactic radiosurgery (SRS) followed 2-3 weeks later by ipilimumab, which is given once every 3 weeks for a total of 4 doses.~Ipilimumab: Ipilimumab 3mg/kg given intravenously over 90 minutes, every 3 weeks for a total of 4 doses.~Stereotactic Radiosurgery: Stereotactic radiosurgery is a type of focused radiation therapy. It requires the placement of a metal frame on the head for several hours."
77898|NCT02097719|B3|Baseline|Total|Total of all reporting groups
77899|NCT02097719|B2|Baseline|Travoprost 0.004% and Timolol 0.5%|Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
77900|NCT02097719|B1|Baseline|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
77901|NCT02097719|P2|Participant Flow|Travoprost 0.004% and Timolol 0.5%|Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
77902|NCT02097719|P1|Participant Flow|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
77903|NCT02097719|O2|Outcome|Travoprost 0.004% and Timolol 0.5%|Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
77904|NCT02097719|O1|Outcome|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
77905|NCT02097719|E2|Reported Event|Travoprost 0.004% and Timolol 0.5%|Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
77906|NCT02097719|E1|Reported Event|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
77907|NCT02097537|B1|Baseline|Methacholine Chloride|"children with bronchial asthma~Methacholine Chloride (SK-1211)"
77908|NCT02097537|P1|Participant Flow|Methacholine Chloride|"children with bronchial asthma~Methacholine Chloride (SK-1211)"
77909|NCT02097537|O1|Outcome|Methacholine Chloride|"children with bronchial asthma~Methacholine Chloride (SK-1211)"
77910|NCT02097537|O1|Outcome|Methacholine Chloride|"children with bronchial asthma~Methacholine Chloride (SK-1211)"
77911|NCT02097537|O1|Outcome|Methacholine Chloride|"children with bronchial asthma~Methacholine Chloride (SK-1211)"
77912|NCT02097537|E1|Reported Event|Methacholine Chloride|"children with bronchial asthma~Methacholine Chloride (SK-1211)"
77913|NCT02097303|B1|Baseline|Radium 223 With Concomitant Abiraterone Acetate and Prednisone|"Name of active ingredient Radium Ra 223 dichloride Dose 50 kBq/kg body weight Route of Administration Intravenous Duration of Treatment One injection every 4 weeks X 6 injections maximum.~Name of active ingredient Abiraterone Acetate plus Prednisone Dose 1000 mg/day and 5 mg BID Route of Administration Oral Duration of Treatment 26 weeks minimum duration. There is no maximum duration."
77914|NCT02097303|P1|Participant Flow|Radium 223 With Concomitant Abiraterone Acetate and Prednisone|"Name of active ingredient Radium Ra 223 dichloride Dose 50 kBq/kg body weight Route of Administration Intravenous Duration of Treatment One injection every 4 weeks X 6 injections maximum.~Name of active ingredient Abiraterone Acetate plus Prednisone Dose 1000 mg/day and 5 mg BID Route of Administration Oral Duration of Treatment 26 weeks minimum duration. There is no maximum duration."
77915|NCT02097303|O1|Outcome|Radium 223 With Concomitant Abiraterone Acetate and Prednisone|"Name of active ingredient Radium Ra 223 dichloride Dose 50 kBq/kg body weight Route of Administration Intravenous Duration of Treatment One injection every 4 weeks X 6 injections maximum.~Name of active ingredient Abiraterone Acetate plus Prednisone Dose 1000 mg/day and 5 mg BID Route of Administration Oral Duration of Treatment 26 weeks minimum duration. There is no maximum duration."
77916|NCT02097303|O1|Outcome|Radium 223 With Concomitant Abiraterone Acetate and Prednisone|"Name of active ingredient Radium Ra 223 dichloride Dose 50 kBq/kg body weight Route of Administration Intravenous Duration of Treatment One injection every 4 weeks X 6 injections maximum.~Name of active ingredient Abiraterone Acetate plus Prednisone Dose 1000 mg/day and 5 mg BID Route of Administration Oral Duration of Treatment 26 weeks minimum duration. There is no maximum duration."
77917|NCT02097303|O1|Outcome|Radium 223 With Concomitant Abiraterone Acetate and Prednisone|"Name of active ingredient Radium Ra 223 dichloride Dose 50 kBq/kg body weight Route of Administration Intravenous Duration of Treatment One injection every 4 weeks X 6 injections maximum.~Name of active ingredient Abiraterone Acetate plus Prednisone Dose 1000 mg/day and 5 mg BID Route of Administration Oral Duration of Treatment 26 weeks minimum duration. There is no maximum duration."
77918|NCT02097303|O1|Outcome|Radium 223 With Concomitant Abiraterone Acetate and Prednisone|"Name of active ingredient Radium Ra 223 dichloride Dose 50 kBq/kg body weight Route of Administration Intravenous Duration of Treatment One injection every 4 weeks X 6 injections maximum.~Name of active ingredient Abiraterone Acetate plus Prednisone Dose 1000 mg/day and 5 mg BID Route of Administration Oral Duration of Treatment 26 weeks minimum duration. There is no maximum duration."
77919|NCT02097303|O1|Outcome|Radium 223 With Concomitant Abiraterone Acetate and Prednisone|"Name of active ingredient Radium Ra 223 dichloride Dose 50 kBq/kg body weight Route of Administration Intravenous Duration of Treatment One injection every 4 weeks X 6 injections maximum.~Name of active ingredient Abiraterone Acetate plus Prednisone Dose 1000 mg/day and 5 mg BID Route of Administration Oral Duration of Treatment 26 weeks minimum duration. There is no maximum duration."
77920|NCT02097303|O1|Outcome|Radium 223 With Concomitant Abiraterone Acetate and Prednisone|"Name of active ingredient Radium Ra 223 dichloride Dose 50 kBq/kg body weight Route of Administration Intravenous Duration of Treatment One injection every 4 weeks X 6 injections maximum.~Name of active ingredient Abiraterone Acetate plus Prednisone Dose 1000 mg/day and 5 mg BID Route of Administration Oral Duration of Treatment 26 weeks minimum duration. There is no maximum duration."
77921|NCT02097303|O1|Outcome|Radium 223 With Concomitant Abiraterone Acetate and Prednisone|"Name of active ingredient Radium Ra 223 dichloride Dose 50 kBq/kg body weight Route of Administration Intravenous Duration of Treatment One injection every 4 weeks X 6 injections maximum.~Name of active ingredient Abiraterone Acetate plus Prednisone Dose 1000 mg/day and 5 mg BID Route of Administration Oral Duration of Treatment 26 weeks minimum duration. There is no maximum duration."
77922|NCT02097303|E1|Reported Event|Radium 223 With Concomitant Abiraterone Acetate and Prednisone|"Name of active ingredient Radium Ra 223 dichloride Dose 50 kBq/kg body weight Route of Administration Intravenous Duration of Treatment One injection every 4 weeks X 6 injections maximum.~Name of active ingredient Abiraterone Acetate plus Prednisone Dose 1000 mg/day and 5 mg BID Route of Administration Oral Duration of Treatment 26 weeks minimum duration. There is no maximum duration."
77923|NCT02097290|B1|Baseline|CRT-D|"For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated~CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated"
77924|NCT02097290|P1|Participant Flow|CRT-D|"For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated~CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated"
77925|NCT02097290|O1|Outcome|CRT-D|"For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated~CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated"
77926|NCT02097290|O1|Outcome|CRT-D|"For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated~CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated"
77927|NCT02097290|O1|Outcome|CRT-D|"For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated~CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated"
77928|NCT02097290|O1|Outcome|CRT-D|"For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated~CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated"
77929|NCT02097290|O1|Outcome|CRT-D|"For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated~CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated"
77930|NCT02097290|O1|Outcome|CRT-D|"For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated~CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated"
77931|NCT02097290|O1|Outcome|CRT-D|"For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated~CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated"
77932|NCT02097290|E1|Reported Event|CRT-D|"CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated.~Subjects in whom AUTOGEN CRT-D was successfully implanted or an attempt to implant made were considered to be at risk for adverse events. There were a total of 210 implants and attempts."
77933|NCT02097238|B1|Baseline|Treatment (Eribulin Mesylate)|Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
77934|NCT02097238|P1|Participant Flow|Treatment (Eribulin Mesylate)|"Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~Eribulin Mesylate: Given IV~Pharmacological Study: Correlative studies"
77935|NCT02097238|O1|Outcome|Treatment (Eribulin Mesylate)|Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
77936|NCT02097238|O1|Outcome|Treatment (Eribulin Mesylate)|Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
77937|NCT02097238|O1|Outcome|Treatment (Eribulin Mesylate)|Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
77938|NCT02097238|E1|Reported Event|Treatment (Eribulin Mesylate)|Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
77939|NCT02097108|B1|Baseline|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.~Raltegravir"
77940|NCT02097108|P1|Participant Flow|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.~Raltegravir"
77941|NCT02097108|O1|Outcome|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.~Raltegravir"
77942|NCT02097108|O1|Outcome|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.~Raltegravir"
77943|NCT02097108|O1|Outcome|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.~Raltegravir"
77944|NCT02097108|O1|Outcome|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.~Raltegravir"
77945|NCT02097108|E1|Reported Event|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.~Raltegravir"
77946|NCT02097056|B1|Baseline|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
77947|NCT02097056|P1|Participant Flow|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
77948|NCT02097056|O1|Outcome|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
77949|NCT02097056|O1|Outcome|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
77950|NCT02097056|O1|Outcome|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
77951|NCT02097056|E1|Reported Event|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
77952|NCT02097030|B3|Baseline|Total|Total of all reporting groups
77953|NCT02097030|B2|Baseline|Nelfilcon A, Then Filcon II 3|"Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.~nelfilcon A: contact lens filcon II 3: contact lens"
77954|NCT02097030|B1|Baseline|Etafilcon A, Then Filcon II 3|"Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.~etafilcon A: contact lens filcon II 3: contact lens"
77955|NCT02097030|P2|Participant Flow|Nelfilcon A, Then Filcon II 3|"Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.~nelfilcon A: contact lens filcon II 3: contact lens"
77956|NCT02097030|P1|Participant Flow|Etafilcon A, Then Filcon II 3|"Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.~etafilcon A: contact lens filcon II 3: contact lens"
78025|NCT02096900|O2|Outcome|Zolpidem|zolpidem was given orally 0.25mg/kg pre-operatively single dose
77957|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77958|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77959|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77960|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77961|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77962|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77963|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77964|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77965|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77966|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77967|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77968|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77969|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77970|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77971|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77972|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77973|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77974|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77975|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77976|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77977|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77978|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77979|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77980|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77981|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77982|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77983|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77984|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77985|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77986|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77987|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77988|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77989|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77990|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
78026|NCT02096900|O1|Outcome|Midazolam|midazolam was given at 0.5mg/kg, pre-operatively single dose
77991|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77992|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77993|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77994|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77995|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77996|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77997|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77998|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
77999|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
78000|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
78001|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
78002|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
78003|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
78004|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
78005|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
78006|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
78007|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
78008|NCT02097030|O2|Outcome|Filcon II 3|"Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A.~(hydrogel: nelfilcon A, etafilcon A) (silicone hydrogel: filcon II 3)"
78009|NCT02097030|O1|Outcome|Hydrogel|"Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A.~(hydrogel: nelfilcon A, etafilcon A) (silicone hydrogel: filcon II 3)"
78010|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
78011|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
78012|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
78013|NCT02097030|E3|Reported Event|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
78014|NCT02097030|E2|Reported Event|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
78015|NCT02097030|E1|Reported Event|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
78016|NCT02096952|B1|Baseline|Methylphenidate Extended-release Liquid|"Methylphenidate extended-release liquid formulation (MPH-ERLF)~The MPH-ERLF was titrated to the target daily dose during the first three weeks of the trial (dose optimization phase) based on a flexible titration schedule as well as tolerability per clinician judgement. Week 3 and onwards, subjects were maintained on maximum achieved dose with a one-time option to decrease the dose of the study medication to the next lowest available dose per clinician judgement based on tolerability."
78017|NCT02096952|P1|Participant Flow|Methylphenidate Extended-release Liquid|"Methylphenidate extended-release liquid formulation (MPH-ERLF)~The MPH-ERLF was titrated to the target daily dose during the first three weeks of the trial (dose optimization phase) based on a flexible titration schedule as well as tolerability per clinician judgement. Week 3 and onwards, subjects were maintained on maximum achieved dose with a one-time option to decrease the dose of the study medication to the next lowest available dose per clinician judgement based on tolerability."
78018|NCT02096952|O1|Outcome|Methylphenidate Extended-release Liquid|Methylphenidate extended-release liquid formulation
78019|NCT02096952|E1|Reported Event|Methylphenidate Extended-release Liquid|Methylphenidate extended-release liquid formulation
78020|NCT02096900|B3|Baseline|Total|Total of all reporting groups
78021|NCT02096900|B2|Baseline|Zolpidem|zolpidem was given orally 0.25mg/kg pre-operatively single dose
78022|NCT02096900|B1|Baseline|Midazolam|midazolam was given at 0.5mg/kg, pre-operatively single dose
78023|NCT02096900|P2|Participant Flow|Zolpidem|zolpidem was given orally 0.25mg/kg pre-operatively single dose
79051|NCT02092961|E1|Reported Event|ADALIMUMAB 40 MG|Dosing Group D
78038|NCT02096861|B4|Baseline|Remicade - CT-P13|"Remicade followed by CT-P13 from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
78039|NCT02096861|B3|Baseline|Remicade - Remicade|"Remicade followed by Remicade from Week 30~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
78040|NCT02096861|B2|Baseline|CT-P13 - Remicade|"CT-P13 followed by Remicade from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
78041|NCT02096861|B1|Baseline|CT-P13 - CT-P13|"CT-P13 followed by CT-P13 from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
78042|NCT02096861|P4|Participant Flow|Remicade - CT-P13|"Remicade followed by CT-P13 from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
78043|NCT02096861|P3|Participant Flow|Remicade - Remicade|"Remicade followed by Remicade from Week 30~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
78044|NCT02096861|P2|Participant Flow|CT-P13 - Remicade|"CT-P13 followed by Remicade from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
78045|NCT02096861|P1|Participant Flow|CT-P13 - CT-P13|"CT-P13 followed by CT-P13 from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
78046|NCT02096861|O4|Outcome|Remicade - CT-P13|"Remicade followed by CT-P13 from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
78047|NCT02096861|O3|Outcome|Remicade - Remicade|"Remicade followed by Remicade from Week 30~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
78048|NCT02096861|O2|Outcome|CT-P13 - Remicade|"CT-P13 followed by Remicade from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
78049|NCT02096861|O1|Outcome|CT-P13 - CT-P13|"CT-P13 followed by CT-P13 from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
78050|NCT02096861|O2|Outcome|Remicade|Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
78051|NCT02096861|O1|Outcome|CT-P13|CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
78052|NCT02096861|O4|Outcome|Remicade - CT-P13|"Remicade followed by CT-P13 from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
78053|NCT02096861|O3|Outcome|Remicade - Remicade|"Remicade followed by Remicade from Week 30~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
78054|NCT02096861|O2|Outcome|CT-P13 - Remicade|"CT-P13 followed by Remicade from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
78055|NCT02096861|O1|Outcome|CT-P13 - CT-P13|"CT-P13 followed by CT-P13 from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
78056|NCT02096861|O2|Outcome|Remicade|Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
78057|NCT02096861|O1|Outcome|CT-P13|CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
78058|NCT02096861|O2|Outcome|Remicade|Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
78059|NCT02096861|O1|Outcome|CT-P13|CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
78060|NCT02096861|O4|Outcome|Remicade - CT-P13|"Remicade followed by CT-P13 from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
78061|NCT02096861|O3|Outcome|Remicade - Remicade|"Remicade followed by Remicade from Week 30~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
78062|NCT02096861|O2|Outcome|CT-P13 - Remicade|"CT-P13 followed by Remicade from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
78063|NCT02096861|O1|Outcome|CT-P13 - CT-P13|"CT-P13 followed by CT-P13 from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
78064|NCT02096861|O2|Outcome|Remicade|Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
78065|NCT02096861|O1|Outcome|CT-P13|CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
78066|NCT02096861|O2|Outcome|Remicade|Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
78067|NCT02096861|O1|Outcome|CT-P13|CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
78068|NCT02096861|E4|Reported Event|Remicade - CT-P13|"Remicade followed by CT-P13 from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
78069|NCT02096861|E3|Reported Event|Remicade - Remicade|"Remicade followed by Remicade from Week 30~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
78070|NCT02096861|E2|Reported Event|CT-P13 - Remicade|"CT-P13 followed by Remicade from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose~Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
79052|NCT02092857|B4|Baseline|Total|Total of all reporting groups
78071|NCT02096861|E1|Reported Event|CT-P13 - CT-P13|"CT-P13 followed by CT-P13 from Week 30~CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose"
78072|NCT02096835|B4|Baseline|Total|Total of all reporting groups
78073|NCT02096835|B3|Baseline|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Dexamethasone: will be given after induction"
78074|NCT02096835|B2|Baseline|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Tropisetron: will be given at the start of skin closure~Dexamethasone: will be given after induction"
78075|NCT02096835|B1|Baseline|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.~Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.~Dexamethasone: will be given after induction"
78076|NCT02096835|P3|Participant Flow|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Dexamethasone: will be given after induction"
78077|NCT02096835|P2|Participant Flow|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Tropisetron: will be given at the start of skin closure~Dexamethasone: will be given after induction"
78078|NCT02096835|P1|Participant Flow|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.~Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.~Dexamethasone: will be given after induction"
78079|NCT02096835|O3|Outcome|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Dexamethasone: will be given after induction"
78080|NCT02096835|O2|Outcome|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Tropisetron: will be given at the start of skin closure~Dexamethasone: will be given after induction"
78081|NCT02096835|O1|Outcome|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.~Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.~Dexamethasone: will be given after induction"
78082|NCT02096835|O3|Outcome|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Dexamethasone: will be given after induction"
78083|NCT02096835|O2|Outcome|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Tropisetron: will be given at the start of skin closure~Dexamethasone: will be given after induction"
78084|NCT02096835|O1|Outcome|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.~Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.~Dexamethasone: will be given after induction"
78085|NCT02096835|O3|Outcome|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Dexamethasone: will be given after induction"
78086|NCT02096835|O2|Outcome|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Tropisetron: will be given at the start of skin closure~Dexamethasone: will be given after induction"
78114|NCT02096731|O1|Outcome|Monotherapy|Participants who can be linked to the Hospital Episode Statistics database and who remained on a single long- acting bronchodilator.
78148|NCT02096705|B2|Baseline|Dapagliflozin|Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
78087|NCT02096835|O1|Outcome|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.~Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.~Dexamethasone: will be given after induction"
78088|NCT02096835|O3|Outcome|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Dexamethasone: will be given after induction"
78089|NCT02096835|O2|Outcome|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Tropisetron: will be given at the start of skin closure~Dexamethasone: will be given after induction"
78090|NCT02096835|O1|Outcome|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.~Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.~Dexamethasone: will be given after induction"
78091|NCT02096835|E3|Reported Event|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Dexamethasone: will be given after induction"
78092|NCT02096835|E2|Reported Event|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Tropisetron: will be given at the start of skin closure~Dexamethasone: will be given after induction"
78093|NCT02096835|E1|Reported Event|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.~Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.~Dexamethasone: will be given after induction"
78094|NCT02096744|B1|Baseline|Overall Study|"A randomised, double-blind, 2-way crossover design, followed by a period for assessment of adhesive properties of the clonidine patch.~In the crossover part of the trial, subjects were treated with either Catapres®-TTS delivering 0.3 mg clonidine/24 h (TTS-3) in the Oppanol® formulation (test treatment T1) or Catapres®-TTS-3 (0.3 mg/24 h) with Vistanex™ formulation (reference treatment R1) in each period. In the adhesion phase of the trial, subjects were treated simultaneously with Oppanol® (test treatment T2) and Vistanex™ (reference treatment R2) patches, each delivering 0.1 mg clonidine/24 h (TTS-1)."
78095|NCT02096744|P2|Participant Flow|Catapres®-TTS-3 Crossover 2: TTS-3 Vistanex Then TTS-3 Oppanol|Catapres®-TTS-3 (0.3 mg/24 hr) Vistanex™ (R1) first, followed by Catapres®-TTS-3 (0.3 mg/24 hr) Oppanol® (T1). Followed by simultaneous administration of TTS-1 Oppanol® (T2) and TTS-1 Vistanex™ (R2) patches each delivering 0.1mg clinidine/24h.
78096|NCT02096744|P1|Participant Flow|Catapres®-TTS-3 Crossover 1: TTS-3 Oppanol Then TTS-3 Vistanex|Catapres®-TTS(Transdermal Therapeutic System)-3 (0.3 mg/24 hr) Oppanol® (T1) first, followed by Catapres®-TTS-3 (0.3 mg/24 hr) Vistanex™ (R1). Followed by simultaneous administration of TTS-1 Oppanol® (T2) and TTS-1 Vistanex™ (R2) patches each delivering 0.1mg clinidine/24h.
78097|NCT02096744|O2|Outcome|Catapres®-TTS-3 With Vistanex™|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Vistanex™ (R1)
78098|NCT02096744|O1|Outcome|Catapres®-TTS-3 With Oppanol®|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Oppanol® (T1)
78099|NCT02096744|O2|Outcome|Catapres-TTS-3 With Vistanex™|Subject to receive 0.3 mg/24 hr Catapres-TTS-3 Vistanex™ (R1)
78100|NCT02096744|O1|Outcome|Catapres®-TTS-3 With Oppanol®|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Oppanol® (T1)
78101|NCT02096744|O2|Outcome|Catapres®-TTS-3 With Vistanex™|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Vistanex™ (R1)
78102|NCT02096744|O1|Outcome|Catapres®-TTS-3 With Oppanol®|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Oppanol® (T1)
78103|NCT02096744|O2|Outcome|Catapres®-TTS-3 With Vistanex™|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Vistanex™ (R1)
78104|NCT02096744|O1|Outcome|Catapres®-TTS-3 With Oppanol®|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Oppanol® (T1)
78105|NCT02096744|E3|Reported Event|TTS-1: Vistanex™ (R2) + Oppanol® (T2)|Simultaneous administration of TTS-1 with Oppanol® and TTS-1 with Vistanex™
78106|NCT02096744|E2|Reported Event|TTS-3: Vistanex™ (R1)|Administration of TTS-3 with Vistanex™
78107|NCT02096744|E1|Reported Event|TTS-3: Oppanol® (T1)|Administration of TTS-3 with Oppanol®
78108|NCT02096731|B3|Baseline|Total|Total of all reporting groups
78109|NCT02096731|B2|Baseline|LABA|Participants who were new users of a long-acting beta2 agonist (LABA) with or without inhaled corticosteroid (ICS).
78110|NCT02096731|B1|Baseline|Tiotropium|Participants who were new users of tiotropium.
78111|NCT02096731|P2|Participant Flow|LABA|Participants who were new users of a long-acting beta2 agonist (LABA) with or without inhaled corticosteroid (ICS).
78112|NCT02096731|P1|Participant Flow|Tiotropium|Participants who were new users of tiotropium.
78113|NCT02096731|O2|Outcome|Combination Therapy|Participants who can be linked to the Hospital Episode Statistics database and who added another long-acting bronchodilator to the previous long-acting bronchodilator.
78115|NCT02096731|O2|Outcome|Combination Therapy|Participants who can be linked to the Hospital Episode Statistics database and who added another long-acting bronchodilator to the previous long-acting bronchodilator.
78116|NCT02096731|O1|Outcome|Monotherapy|Participants who can be linked to the Hospital Episode Statistics database and who remained on a single long-acting bronchodilator.
78117|NCT02096731|O2|Outcome|Combination Therapy|Participants who added another long-acting bronchodilator to the previous long-acting bronchodilator (Tiotropium plus LABA+/-ICS) - combination therapy
78118|NCT02096731|O1|Outcome|Monotherapy|Participants remaining on a single long-acting bronchodilator - monotherapy.
78119|NCT02096731|O2|Outcome|Combination Therapy|Participants who added another long-acting bronchodilator to the previous long-acting bronchodilator (Tiotropium plus LABA+/-ICS) - combination therapy
78120|NCT02096731|O1|Outcome|Monotherapy|Participants remaining on a single long-acting bronchodilator - monotherapy.
78121|NCT02096731|O2|Outcome|Combination Therapy|Participants who added another long-acting bronchodilator to the previous long-acting bronchodilator (Tiotropium plus LABA+/-ICS) - combination therapy
78122|NCT02096731|O1|Outcome|Monotherapy|Participants remaining on a single long-acting bronchodilator - monotherapy.
78123|NCT02096731|E2|Reported Event|LABA|Participants who were new users of a long-acting beta2 agonist (LABA) with or without inhaled corticosteroid (ICS).
78124|NCT02096731|E1|Reported Event|Tiotropium|Participants who were new users of tiotropium.
78125|NCT02096718|B4|Baseline|Total|Total of all reporting groups
78126|NCT02096718|B3|Baseline|Afatinib in Healthy Subjects|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate and severe renal impaired subjects
78127|NCT02096718|B2|Baseline|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
78128|NCT02096718|B1|Baseline|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
78129|NCT02096718|P3|Participant Flow|Afatinib in Healthy Subjects|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate and severe renal impaired subjects
78130|NCT02096718|P2|Participant Flow|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
78131|NCT02096718|P1|Participant Flow|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
78132|NCT02096718|O4|Outcome|Afatinib in Healthy Subjects Matched to Severe|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to severe renal impaired subjects
78133|NCT02096718|O3|Outcome|Afatinib in Healthy Subjects Matched to Moderate|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate renal impaired subjects
78134|NCT02096718|O2|Outcome|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
78135|NCT02096718|O1|Outcome|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
78136|NCT02096718|O4|Outcome|Afatinib in Healthy Subjects Matched to Severe|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to severe renal impaired subjects
78137|NCT02096718|O3|Outcome|Afatinib in Healthy Subjects Matched to Moderate|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate renal impaired subjects
78138|NCT02096718|O2|Outcome|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
78139|NCT02096718|O1|Outcome|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
78140|NCT02096718|O4|Outcome|Afatinib in Healthy Subjects Matched to Severe|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to severe renal impaired subjects
78141|NCT02096718|O3|Outcome|Afatinib in Healthy Subjects Matched to Moderate|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate renal impaired subjects
78142|NCT02096718|O2|Outcome|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
78143|NCT02096718|O1|Outcome|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
78144|NCT02096718|E3|Reported Event|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
78145|NCT02096718|E2|Reported Event|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
78146|NCT02096718|E1|Reported Event|Afatinib in Healthy Subjects|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate and severe renal impaired subjects
78147|NCT02096705|B3|Baseline|Total|Total of all reporting groups
78149|NCT02096705|B1|Baseline|Placebo|Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
78150|NCT02096705|P2|Participant Flow|Dapagliflozin|Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
78151|NCT02096705|P1|Participant Flow|Placebo|Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
78152|NCT02096705|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
78153|NCT02096705|O1|Outcome|Placebo|Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
78154|NCT02096705|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
78155|NCT02096705|O1|Outcome|Placebo|Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
78156|NCT02096705|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
78157|NCT02096705|O1|Outcome|Placebo|Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
78158|NCT02096705|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
78159|NCT02096705|O1|Outcome|Placebo|Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
78160|NCT02096705|E2|Reported Event|Placebo|Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
78161|NCT02096705|E1|Reported Event|Dapagliflozin|Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
78162|NCT02096692|B1|Baseline|ICD System Therapy|"Patients with a ProMRI ICD System~Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
78163|NCT02096692|P1|Participant Flow|ICD System Therapy|"Patients with a ProMRI ICD System~Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
78164|NCT02096692|O1|Outcome|ICD System Therapy|"Patients with a ProMRI ICD System~Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
78165|NCT02096692|O1|Outcome|ICD System Therapy|"Patients with a ProMRI ICD System~Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
78166|NCT02096692|O1|Outcome|ICD System Therapy|"Patients with a ProMRI ICD System~Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
78167|NCT02096692|E1|Reported Event|ICD System Therapy|"Patients with a ProMRI ICD System~Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
78168|NCT02096679|B1|Baseline|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
78169|NCT02096679|P1|Participant Flow|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
78170|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
78171|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
78172|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
78173|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
78174|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
78175|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
78176|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
78177|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
78178|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
78179|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
78180|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
78181|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
78182|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
78183|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
78184|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
78185|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
78186|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
78187|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
78418|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
78188|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
78189|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
78190|NCT02096679|E1|Reported Event|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
78191|NCT02096575|B3|Baseline|Total|Total of all reporting groups
78192|NCT02096575|B2|Baseline|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
78193|NCT02096575|B1|Baseline|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously.~Nitrous oxide administration"
78194|NCT02096575|P3|Participant Flow|Excluded|Participants that were withdrawn from the study after consent
78195|NCT02096575|P2|Participant Flow|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
78196|NCT02096575|P1|Participant Flow|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously.~Nitrous oxide administration"
78197|NCT02096575|O2|Outcome|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
78198|NCT02096575|O1|Outcome|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously."
78199|NCT02096575|O2|Outcome|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
78200|NCT02096575|O1|Outcome|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously."
78201|NCT02096575|O2|Outcome|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
78202|NCT02096575|O1|Outcome|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously.~Nitrous oxide administration: The NO group will get two placebo pills."
78203|NCT02096575|O2|Outcome|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
78419|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
78204|NCT02096575|O1|Outcome|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously.~Nitrous oxide administration: The NO group will get two placebo pills."
78205|NCT02096575|O2|Outcome|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
78206|NCT02096575|O1|Outcome|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously."
78207|NCT02096575|E2|Reported Event|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
78208|NCT02096575|E1|Reported Event|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously.~Nitrous oxide administration: The NO group will get two placebo pills."
78209|NCT02096458|B1|Baseline|Dexlansoprazole|Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
78210|NCT02096458|P1|Participant Flow|Dexlansoprazole|Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
78211|NCT02096458|O1|Outcome|Dexlansoprazole|Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
78212|NCT02096458|E1|Reported Event|Dexlansoprazole|Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
78213|NCT02096081|B3|Baseline|Total|Total of all reporting groups
78214|NCT02096081|B2|Baseline|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78215|NCT02096081|B1|Baseline|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78216|NCT02096081|P2|Participant Flow|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78217|NCT02096081|P1|Participant Flow|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78218|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78219|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78220|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78221|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78222|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78223|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78224|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78225|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78226|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78290|NCT02095561|B2|Baseline|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
78227|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78228|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78229|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78230|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78231|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78232|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78233|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78234|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78235|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78236|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78237|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78238|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78239|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78240|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78241|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78242|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78243|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78244|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78245|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78246|NCT02096081|E2|Reported Event|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U/injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78247|NCT02096081|E1|Reported Event|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U/injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
78248|NCT02096042|B1|Baseline|Brentuximab Vedotin|Pilot Phase: Starting dose of Brentuximab Vedotin 1.2 mg/kg intravenous (IV) infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle (+/- 3 days).
78249|NCT02096042|P3|Participant Flow|MTD Brentuximab Vedotin + 5-Azacytidine|Phase II Dose-Expansion Phase: Brentuximab Vedotin at MTD from dose-escalation phase IV on Days 1, 8, and 15 of each 28-day cycle. 5-Azacytidine at 75 mg/m2/day IV or subcutaneously on days 1-7 every 28 days.Up to 12 cycles of treatment (weekly + monthly combined).
78250|NCT02096042|P2|Participant Flow|Brentuximab Vedotin + 5-Azacytidine|Phase I Dose-Escalation Phase: Starting dose of Brentuximab Vedotin 1.0 mg/kg IV (starting dose level 1), or one-dose level lower than the established MTD if the pilot portion of the study establishes a lower MTD, infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle. 5-azacytidine at 75 mg/m2/day IV or subcutaneously on days 1-7 every 28 days.
78251|NCT02096042|P1|Participant Flow|Brentuximab Vedotin|Pilot Phase: Starting dose of Brentuximab Vedotin 1.2 mg/kg intravenous (IV) infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle (+/- 3 days).
78252|NCT02096042|O3|Outcome|MTD Brentuximab Vedotin + 5-Azacytidine|Phase II Dose-Expansion Phase: Brentuximab Vedotin at MTD from dose-escalation phase IV on Days 1, 8, and 15 of each 28-day cycle. 5-Azacytidine at 75 mg/m2/day IV or subcutaneously on days 1-7 every 28 days.Up to 12 cycles of treatment (weekly + monthly combined).
78291|NCT02095561|B1|Baseline|HPV Self Testing|"HPV self testing offered by CHWs during home visits~HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
78253|NCT02096042|O2|Outcome|Brentuximab Vedotin + 5-Azacytidine|Phase I Dose-Escalation Phase: Starting dose of Brentuximab Vedotin 1.0 mg/kg IV (starting dose level 1), or one-dose level lower than the established MTD if the pilot portion of the study establishes a lower MTD, infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle. 5-azacytidine at 75 mg/m2/day IV or subcutaneously on days 1-7 every 28 days.
78254|NCT02096042|O1|Outcome|Brentuximab Vedotin|Pilot Phase: Starting dose of Brentuximab Vedotin 1.2 mg/kg intravenous (IV) infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle (+/- 3 days).
78255|NCT02096042|O1|Outcome|Brentuximab Vedotin + 5-Azacytidine|Phase I Dose-Escalation Phase: Starting dose of Brentuximab Vedotin 1.0 mg/kg IV (starting dose level 1), or one-dose level lower than the established MTD if the pilot portion of the study establishes a lower MTD, infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle. 5-azacytidine at 75 mg/m2/day IV or subcutaneously on days 1-7 every 28 days.
78256|NCT02096042|E1|Reported Event|Brentuximab Vedotin|Pilot Phase: Starting dose of Brentuximab Vedotin 1.2 mg/kg intravenous (IV) infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle (+/- 3 days).
78257|NCT02095873|B3|Baseline|Total|Total of all reporting groups
78258|NCT02095873|B2|Baseline|Placebo Then Glyoxalase 1 Inducer|Placebo (excipient: 108 mg mannitol), once daily, 8 weeks; then Glyoxalase 1 inducer (90 mg trans-resveratrol & 120 mg hesperetin), once daily, 8 weeks.
78259|NCT02095873|B1|Baseline|Glyoxalase 1 Inducer Then Placebo|Glyoxalase 1 inducer (90 mg trans-resveratrol & 120 mg hesperetin), once daily, 8 weeks; then Placebo (excipient: 108 mg mannitol), once daily, 8 weeks.
78260|NCT02095873|P2|Participant Flow|Placebo Then Glyoxalase 1 Inducer|Placebo (excipient: Mannitol, 108 mg), once daily, 8 weeks; then Glyoxalase 1 inducer (capsule, 90 mg trans-resveratrol & 120 mg hesperetin combination) once daily, 8 weeks.
78261|NCT02095873|P1|Participant Flow|Glyoxalase 1 Inducer First, Then Placebo|Glyoxalase 1 inducer (capsule, 90 mg trans-resveratrol & 120 mg hesperetin combination) once daily, 8 weeks; then Placebo (excipient: Mannitol, 108 mg) once daily, 8 weeks.
78262|NCT02095873|O2|Outcome|Placebo|Placebo (excipient: Mannitol, 108 mg), once daily, 8 weeks.
78263|NCT02095873|O1|Outcome|Glyoxalase 1 Inducer|Glyoxalase 1 inducer (capsule, 90 mg trans-resveratrol & 120 mg hesperetin combination) once daily, 8 weeks.
78264|NCT02095873|O2|Outcome|Placebo|Placebo (excipient: Mannitol, 108 mg), once daily, 8 weeks.
78265|NCT02095873|O1|Outcome|Glyoxalase 1 Inducer|Glyoxalase 1 inducer (capsule, 90 mg trans-resveratrol & 120 mg hesperetin combination) once daily, 8 weeks.
78266|NCT02095873|O2|Outcome|Placebo|Placebo (excipient: Mannitol, 108 mg), once daily, 8 weeks.
78267|NCT02095873|O1|Outcome|Glyoxalase 1 Inducer|Glyoxalase 1 inducer (capsule, 90 mg trans-resveratrol & 120 mg hesperetin combination) once daily, 8 weeks.
78268|NCT02095873|O2|Outcome|Placebo|Placebo (excipient: 108 mg mannitol), capsule, once daily, 8 weeks.
78269|NCT02095873|O1|Outcome|Glyoxalase 1 Inducer|Glyoxalase 1 inducer (90 mg trans-resveratrol & 120 mg hesperetin), once daily, 8 weeks.
78270|NCT02095873|E2|Reported Event|Placebo Then Glo1-inducer|Placebo capsule (mannitol, 210 mg), once daily for 8 weeks; then 6-weeks washout; then Glyoxalase 1 inducer: capsule, 90 mg trans-resveratrol & 120 mg hesperetin, once daily for 8 weeks.
78271|NCT02095873|E1|Reported Event|Glo1-inducer Then Placebo|Glyoxalase 1 inducer: capsule, 90 mg trans-resveratrol & 120 mg hesperetin, once daily for 8 weeks; then 6-weeks washout; then placebo capsule (mannitol, 210 mg), once daily for 8 weeks.
78272|NCT02095691|B1|Baseline|Renal Artery Sympathetic Denervation|Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
78273|NCT02095691|P1|Participant Flow|Renal Artery Sympathetic Denervation|Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
78274|NCT02095691|O4|Outcome|At 12 Month Follow Up|Percentage of subjects achieving target SBP reduction at 12 months follow up
78275|NCT02095691|O3|Outcome|At 6 Months Follow Up|Percentage of subjects achieving target SBP reduction at 6 months follow up
78276|NCT02095691|O2|Outcome|At 3 Months Follow Up|Percentage of subjects achieving target SBP reduction at 3 months follow up
78277|NCT02095691|O1|Outcome|At 1 Month Follow up|Percentage of subjects achieving target SBP reduction at 1 month follow up
78278|NCT02095691|O4|Outcome|At 12 Month Follow Up|Percentage of subjects achieving target SBP at 12 months follow up
78279|NCT02095691|O3|Outcome|At 6 Months Follow Up|Percentage of subjects achieving target SBP at 6 months follow up
78280|NCT02095691|O2|Outcome|At 3 Months Follow Up|Percentage of subjects achieving target SBP at 3 months follow up
78281|NCT02095691|O1|Outcome|At 1 Month Follow up|Percentage of subjects achieving target SBP at 1 month follow up
78282|NCT02095691|O4|Outcome|Change in Blood Pressure at 12 Month Follow Up|Change in Blood Pressure from baseline to 12 months follow up
78283|NCT02095691|O3|Outcome|Change in Blood Pressure at 6 Months Follow Up|Change in Blood Pressure from baseline to 6 months follow up
78284|NCT02095691|O2|Outcome|Change in Blood Pressure at 3 Months Follow Up|Change in Blood Pressure from baseline to3 months follow up
78285|NCT02095691|O1|Outcome|Change in Blood Pressure at 1 Month Follow up|Change in Blood Pressure from baseline to1 month follow up
78286|NCT02095691|O1|Outcome|Renal Artery Sympathetic Denervation|Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
78287|NCT02095691|O1|Outcome|Renal Artery Sympathetic Denervation|Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
78288|NCT02095691|E1|Reported Event|Renal Artery Sympathetic Denervation|Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
78289|NCT02095561|B3|Baseline|Total|Total of all reporting groups
78292|NCT02095561|P2|Participant Flow|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
78293|NCT02095561|P1|Participant Flow|HPV Self Testing|"HPV self testing offered by CHWs during home visits~HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
78294|NCT02095561|O2|Outcome|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
78295|NCT02095561|O1|Outcome|HPV Self Testing|"HPV self testing offered by CHWs during home visits~HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
78296|NCT02095561|O2|Outcome|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
78297|NCT02095561|O1|Outcome|HPV Self Testing|"HPV self testing offered by CHWs during home visits~HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
78298|NCT02095561|O2|Outcome|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
78299|NCT02095561|O1|Outcome|HPV Self Testing|"HPV self testing offered by CHWs during home visits~HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
78300|NCT02095561|O2|Outcome|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
78301|NCT02095561|O1|Outcome|HPV Self Testing|"HPV self testing offered by CHWs during home visits~HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
78302|NCT02095561|E2|Reported Event|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
78303|NCT02095561|E1|Reported Event|HPV Self Testing|"HPV self testing offered by CHWs during home visits~HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
78304|NCT02095535|B1|Baseline|Study Group|"All study participants~Chlorhexidine gluconate: antiseptic"
78305|NCT02095535|P1|Participant Flow|Study Group|"All study participants~Chlorhexidine gluconate: antiseptic"
78306|NCT02095535|O1|Outcome|Study Group|"All study participants~Chlorhexidine gluconate: antiseptic"
78307|NCT02095535|E1|Reported Event|Study Group|"All study participants~Chlorhexidine gluconate: antiseptic"
78308|NCT02095223|B3|Baseline|Total|Total of all reporting groups
78309|NCT02095223|B2|Baseline|Traditional Exercise Group|"Participants in will be instructed on a 14 day exercise protocol on the day of enrollment. The protocol is comprised of 4 exercises focused on both non-weight bearing and weight bearing quadriceps strengthening. A compliance log will be given to each participant and will be reviewed at each supervised exercise session and at the final study visit. Participants will be instructed to discontinue exercise and contact the principle investigator if they experience knee pain due to the intervention.~Traditional Exercise: All participants will be asked to complete 3 set of 10 repetitions of isometric quadriceps contractions with a 15 second hold time, supine straight leg raises, body weight squatting, and body weight lunges daily. Participants will be required to complete the single limb exercises on the previously injured limb only."
78310|NCT02095223|B1|Baseline|Electromyographic Biofeedback Group|Electromyographic Biofeedback: Electromyographic biofeedback is a device that enables a patient or clinician to measure the intensity of a muscle contraction using electrodes placed on the skin over a muscle of interest. In this study, participants in the electromyographic biofeedback supplemented exercise will also be instructed on correct setup and use of the electromyographic biofeedback unit. These instructions will focus on correct placement of the electromyographic recording electrodes over quadriceps muscle as well as correct tuning of the feedback threshold for each exercise to maximize the benefit of the intervention. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group.
78311|NCT02095223|P2|Participant Flow|Traditional Exercise Group|"Participants in will be instructed on a 14 day exercise protocol on the day of enrollment. The protocol is comprised of 4 exercises focused on both non-weight bearing and weight bearing quadriceps strengthening. A compliance log will be given to each participant and will be reviewed at each supervised exercise session and at the final study visit. Participants will be instructed to discontinue exercise and contact the principle investigator if they experience knee pain due to the intervention.~Traditional Exercise: All participants will be asked to complete 3 set of 10 repetitions of isometric quadriceps contractions with a 15 second hold time, supine straight leg raises, body weight squatting, and body weight lunges daily. Participants will be required to complete the single limb exercises on the previously injured limb only."
78327|NCT02095197|O1|Outcome|No Catheter Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~No Catheter Delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
78328|NCT02095197|O2|Outcome|Catheter Targeted Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~Catheter targeted delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
78420|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
78312|NCT02095223|P1|Participant Flow|Electromyographic Biofeedback Group|"Participants in the electromyographic biofeedback supplemented exercise will be instructed on correct setup and use of the electromyographic biofeedback unit. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group. Participants in will be instructed on a 14 day exercise protocol on the day of enrollment. The protocol is comprised of 4 exercises focused on both non-weight bearing and weight bearing quadriceps strengthening. A compliance log will be given to each participant and will be reviewed at each supervised exercise session and at the final study visit. Participants will be instructed to discontinue exercise and contact the principle investigator if they experience knee pain due to the intervention.~Electromyographic Biofeedback: Electromyographic biofeedback is a device that enables a patient or clinician to measure the intensity of a muscle contraction using electrodes placed on the skin over a muscle of interest."
78313|NCT02095223|O2|Outcome|Traditional Exercise Group|Traditional Exercise: All participants will be asked to complete 3 set of 10 repetitions of isometric quadriceps contractions with a 15 second hold time, supine straight leg raises, body weight squatting, and body weight lunges daily. Participants will be required to complete the single limb exercises on the previously injured limb only.
78314|NCT02095223|O1|Outcome|Electromyographic Biofeedback Group|Electromyographic Biofeedback: Electromyographic biofeedback is a device that enables a patient or clinician to measure the intensity of a muscle contraction using electrodes placed on the skin over a muscle of interest. In this study, participants in the electromyographic biofeedback supplemented exercise will also be instructed on correct setup and use of the electromyographic biofeedback unit. These instructions will focus on correct placement of the electromyographic recording electrodes over quadriceps muscle as well as correct tuning of the feedback threshold for each exercise to maximize the benefit of the intervention. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group.
78315|NCT02095223|O2|Outcome|Traditional Exercise Group|Traditional Exercise: All participants will be asked to complete 3 set of 10 repetitions of isometric quadriceps contractions with a 15 second hold time, supine straight leg raises, body weight squatting, and body weight lunges daily. Participants will be required to complete the single limb exercises on the previously injured limb only.
78316|NCT02095223|O1|Outcome|Electromyographic Biofeedback Group|Electromyographic Biofeedback: Electromyographic biofeedback is a device that enables a patient or clinician to measure the intensity of a muscle contraction using electrodes placed on the skin over a muscle of interest. In this study, participants in the electromyographic biofeedback supplemented exercise will also be instructed on correct setup and use of the electromyographic biofeedback unit. These instructions will focus on correct placement of the electromyographic recording electrodes over quadriceps muscle as well as correct tuning of the feedback threshold for each exercise to maximize the benefit of the intervention. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group.
78317|NCT02095223|E2|Reported Event|Traditional Exercise Group|Traditional Exercise: All participants will be asked to complete 3 set of 10 repetitions of isometric quadriceps contractions with a 15 second hold time, supine straight leg raises, body weight squatting, and body weight lunges daily. Participants will be required to complete the single limb exercises on the previously injured limb only.
78318|NCT02095223|E1|Reported Event|Electromyographic Biofeedback Group|Electromyographic Biofeedback: Electromyographic biofeedback is a device that enables a patient or clinician to measure the intensity of a muscle contraction using electrodes placed on the skin over a muscle of interest. In this study, participants in the electromyographic biofeedback supplemented exercise will also be instructed on correct setup and use of the electromyographic biofeedback unit. These instructions will focus on correct placement of the electromyographic recording electrodes over quadriceps muscle as well as correct tuning of the feedback threshold for each exercise to maximize the benefit of the intervention. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group.
78319|NCT02095197|B3|Baseline|Total|Total of all reporting groups
78320|NCT02095197|B2|Baseline|Catheter Targeted Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~Catheter targeted delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
78321|NCT02095197|B1|Baseline|No Catheter Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~No Catheter Delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
78322|NCT02095197|P2|Participant Flow|Catheter Targeted Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~Catheter targeted delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
78323|NCT02095197|P1|Participant Flow|No Catheter Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~No Catheter Delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
78324|NCT02095197|O2|Outcome|Catheter Targeted Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~Catheter targeted delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
78325|NCT02095197|O1|Outcome|No Catheter Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~No Catheter Delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
78326|NCT02095197|O2|Outcome|Catheter Targeted Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~Catheter targeted delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
78416|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
78646|NCT02094261|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
78329|NCT02095197|O1|Outcome|No Catheter Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~No Catheter Delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
78330|NCT02095197|O2|Outcome|Catheter Targeted Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~Catheter targeted delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
78331|NCT02095197|O1|Outcome|No Catheter Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~No Catheter Delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
78332|NCT02095197|E2|Reported Event|Catheter Targeted Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~Catheter targeted delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
78333|NCT02095197|E1|Reported Event|No Catheter Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~No Catheter Delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
78334|NCT02095158|B1|Baseline|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
78335|NCT02095158|P1|Participant Flow|Oxymetazoline HCL Cream 1.0%|Oxymetazoline hydrogen chloride (HCL) Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
78336|NCT02095158|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
78337|NCT02095158|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
78338|NCT02095158|E1|Reported Event|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
78339|NCT02095106|B3|Baseline|Total|Total of all reporting groups
78340|NCT02095106|B2|Baseline|Waterproof Cast First|"Patients in this group received a waterproof cast for 2 weeks, after which the waterproof cast was removed and a traditional fiberglass cast applied for an additional two weeks.~Waterproof Cast~Traditional cast"
78341|NCT02095106|B1|Baseline|Traditional Cast First|"Patients in this group first received a traditional fiberglass cast for two weeks, after which this cast was removed and a waterproof cast applied.~Waterproof Cast~Traditional cast"
78342|NCT02095106|P2|Participant Flow|Waterproof Cast First|"Patients in this group received a waterproof cast for 2 weeks, after which the waterproof cast was removed and a traditional fiberglass cast applied for an additional two weeks.~Waterproof Cast~Traditional cast"
78343|NCT02095106|P1|Participant Flow|Traditional Cast First|"Patients in this group first received a traditional fiberglass cast for two weeks, after which this cast was removed and a waterproof cast applied.~Waterproof Cast~Traditional cast"
78344|NCT02095106|O2|Outcome|Waterproof Cast First|Patients in this group received a waterproof cast for 2 weeks, as the first or second study intervention.
78345|NCT02095106|O1|Outcome|Traditional Cast|Patients in this group received a traditional fiberglass cast for two weeks as the first or second study intervention
78346|NCT02095106|O2|Outcome|Waterproof Cast|Patients in this group received a waterproof cast for 2 weeks, as the first or second study intervention.
78347|NCT02095106|O1|Outcome|Traditional Cast|Patients in this group received a traditional fiberglass cast for two weeks, as the first or second study intervention.
78348|NCT02095106|O2|Outcome|Waterproof Cast|Patients in this group received a waterproof cast for 2 weeks, as the first or second study intervention.
78349|NCT02095106|O1|Outcome|Traditional Cast|Patients in this group received a traditional fiberglass cast for two weeks, as the first or second study intervention.
78350|NCT02095106|O2|Outcome|Waterproof Cast First|Patients in this group received a waterproof cast for 2 weeks, as the first or second study intervention.
78351|NCT02095106|O1|Outcome|Traditional Cast|Patients in this group received a traditional fiberglass cast for two weeks as the first or second study intervention
78352|NCT02095106|O2|Outcome|Waterproof Cast First|Patients in this group received a waterproof cast for 2 weeks, as the first or second study intervention.
78353|NCT02095106|O1|Outcome|Traditional Cast|Patients in this group received a traditional fiberglass cast for two weeks as the first or second study intervention
78354|NCT02095106|O2|Outcome|Waterproof Cast|Patients in this group were assessed after wearing a waterproof cast for 2 weeks, as the first or second intervention type.
78355|NCT02095106|O1|Outcome|Traditional Cast|Patients in this group were assessed after wearing the traditional cast for 2 weeks, as their first or second intervention.
78356|NCT02095106|E2|Reported Event|Waterproof Cast|Patients in this group receives a waterproof cast for 2 weeks, as the first or second study intervention
78357|NCT02095106|E1|Reported Event|Traditional Cast|Patients in this group received a traditional fiberglass cast for two weeks, as the first or second study intervention
78358|NCT02094937|B1|Baseline|Period 1- FF/VI 100/25 mcg OD|Participants received FF/VI 100/25 microgram (mcg) once daily (OD) via a dry powder inhaler for 8 weeks in the open-label treatment period. Participants were allowed to use rescue medication during the study.
78359|NCT02094937|P4|Participant Flow|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78360|NCT02094937|P3|Participant Flow|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78417|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
78647|NCT02094261|E1|Reported Event|AZD9291 80mg|Daily single dose of AZD9291 80mg
78361|NCT02094937|P2|Participant Flow|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78362|NCT02094937|P1|Participant Flow|FF/VI 100/25 mcg OD|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 microgram (mcg) once daily (OD) via a dry powder inhaler for 8 weeks in the open-label treatment period. Participants were allowed to use rescue medication during the study.
78363|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78364|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78365|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78366|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78367|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78368|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78369|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78370|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78371|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78372|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78373|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78374|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78375|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78376|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78377|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78378|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78379|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78380|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78381|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78382|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78383|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78384|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78385|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78386|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78387|NCT02094937|E4|Reported Event|FP 250 mcg BD Period 2|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78388|NCT02094937|E3|Reported Event|FP 100 mcg BD Period 2|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78389|NCT02094937|E2|Reported Event|FF 100 mcg OD Period 2|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
78390|NCT02094937|E1|Reported Event|FF/VI 100/25 mcg OD Period 1|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 microgram (mcg) once daily (OD) via a dry powder inhaler for 8 weeks in the open-label treatment period. Participants were allowed to use rescue medication during the study.
78391|NCT02094898|B1|Baseline|Ketamine Infusion|"This trial was conducted in 2 phases. During the acute-phase, i.v. ketamine was administered thrice-weekly for up to 2 weeks.Those who achieved depressive symptom remission received continuation-phase treatment that consisted of once-weekly i.v. ketamine infusions for 4 additional weeks. Remission could occur after any of the 6 acute-phase infusions, at which point the next infusion was the first (of four) continuation-phase infusions. Individuals who remitted during acute-phase and completed continuation-phase treatment had 4 additional weekly post-continuation follow-up visits.~Ketamine: 0.3 mg/kg/hr of ketamine infused for 100 minutes"
78392|NCT02094898|P1|Participant Flow|Ketamine Infusion|"This trial was conducted in 2 phases. During the acute-phase, i.v. ketamine was administered thrice-weekly for up to 2 weeks.Those who achieved depressive symptom remission received continuation-phase treatment that consisted of once-weekly i.v. ketamine infusions for 4 additional weeks. Remission could occur after any of the 6 acute-phase infusions, at which point the next infusion was the first (of four) continuation-phase infusions. Individuals who remitted during acute-phase and completed continuation-phase treatment had 4 additional weekly post-continuation follow-up visits.~Ketamine: 0.3 mg/kg/hr of ketamine infused for 100 minutes"
78393|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
78394|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
78395|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
78396|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
78397|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
78398|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
78399|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
78400|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
78401|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
78402|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
78403|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
78404|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
78405|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
78406|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
78407|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
78408|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
78409|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
78410|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
78411|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
78412|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
78413|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
78414|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
78415|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
78648|NCT02093962|B3|Baseline|Total|Total of all reporting groups
78421|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
78422|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
78423|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
78424|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
78425|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
78426|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
78427|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
78428|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
78429|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
78430|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
78431|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
78432|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
78433|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
78434|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
78435|NCT02094898|E1|Reported Event|Ketamine Infusion|"This trial was conducted in 2 phases. During the acute-phase, i.v. ketamine was administered thrice-weekly for up to 2 weeks.Those who achieved depressive symptom remission received continuation-phase treatment that consisted of once-weekly i.v. ketamine infusions for 4 additional weeks. Remission could occur after any of the 6 acute-phase infusions, at which point the next infusion was the first (of four) continuation-phase infusions. Individuals who remitted during acute-phase and completed continuation-phase treatment had 4 additional weekly post-continuation follow-up visits.~Ketamine: 0.3 mg/kg/hr of ketamine infused for 100 minutes"
78436|NCT02094885|B3|Baseline|Total|Total of all reporting groups
78437|NCT02094885|B2|Baseline|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
78438|NCT02094885|B1|Baseline|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
78439|NCT02094885|P2|Participant Flow|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
78440|NCT02094885|P1|Participant Flow|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
78441|NCT02094885|O2|Outcome|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
78442|NCT02094885|O1|Outcome|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
78443|NCT02094885|O2|Outcome|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
78444|NCT02094885|O1|Outcome|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
78445|NCT02094885|O2|Outcome|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
78446|NCT02094885|O1|Outcome|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
78447|NCT02094885|O2|Outcome|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
78448|NCT02094885|O1|Outcome|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
78449|NCT02094885|E2|Reported Event|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
78450|NCT02094885|E1|Reported Event|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
78451|NCT02094677|B3|Baseline|Total|Total of all reporting groups
78452|NCT02094677|B2|Baseline|Filcon II 3 and Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78453|NCT02094677|B1|Baseline|Filcon II 3 and Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78454|NCT02094677|P2|Participant Flow|Filcon II 3 and Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78455|NCT02094677|P1|Participant Flow|Filcon II 3 and Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78456|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78457|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78458|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78459|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78460|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78461|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78462|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78463|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78464|NCT02094677|O2|Outcome|Control - Nelilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78465|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78466|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78467|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78468|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78469|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78470|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78471|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78472|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78473|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78474|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78475|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78476|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78477|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78478|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens"
78479|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens"
78480|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78481|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78482|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78483|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78484|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78485|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78486|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78487|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78488|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78489|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78490|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78491|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78492|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78493|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78494|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78495|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78496|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78497|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78498|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78499|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78500|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78501|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78502|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78503|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78504|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78505|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78506|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78507|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78508|NCT02094677|O2|Outcome|Filcon II 3 and Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78509|NCT02094677|O1|Outcome|Filcon II 3 and Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78510|NCT02094677|O2|Outcome|Filcon II 3 and Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78511|NCT02094677|O1|Outcome|Filcon II 3 and Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78512|NCT02094677|O2|Outcome|Filcon II 3 and Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
78513|NCT02094677|O1|Outcome|Filcon II 3 and Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
78514|NCT02094677|E2|Reported Event|Filcon II 3 and Nelfilcon A|"Participants wear one of their habitual brand lenses (nelfilcon A) in one eye, (comparator) and one comparator lens (filcon II 3) in the other eye.~filcon II 3: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other.~nelfilcon A: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other."
78515|NCT02094677|E1|Reported Event|Filcon II 3 and Etafilcon A|"Participants wear one of their habitual brand lenses (etafilcon A) in one eye, (comparator) and one comparator lens (filcon II 3) in the other eye.~filcon II 3: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other.~etafilcon A: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other."
78516|NCT02094664|B3|Baseline|Total|Total of all reporting groups
78517|NCT02094664|B2|Baseline|Treatment|Heated and humidified oxygen therapy
78518|NCT02094664|B1|Baseline|Control|Standard dry oxygen therapy
78519|NCT02094664|P2|Participant Flow|Treatment|Heated and humidified oxygen therapy
78520|NCT02094664|P1|Participant Flow|Control|Standard dry oxygen therapy
78521|NCT02094664|O2|Outcome|Treatment|Heated and humidified oxygen therapy
78522|NCT02094664|O1|Outcome|Control|Standard dry therapy therapy
78523|NCT02094664|O2|Outcome|Treatment|Heated and humidified oxygen therapy
78524|NCT02094664|O1|Outcome|Control|Standard dry therapy therapy
78525|NCT02094664|O2|Outcome|Treatment|Heated and humidified oxygen therapy
78526|NCT02094664|O1|Outcome|Control|Standard dry therapy therapy
78527|NCT02094664|O2|Outcome|Treatment|Heated and humidified oxygen therapy
78528|NCT02094664|O1|Outcome|Control|Standard dry therapy therapy
78529|NCT02094664|E2|Reported Event|Treatment|Heated and humidified oxygen therapy
78530|NCT02094664|E1|Reported Event|Control|Standard dry oxygen therapy
78531|NCT02094612|B3|Baseline|Total|Total of all reporting groups
78532|NCT02094612|B2|Baseline|Usual Care Plus Assessment|"Usual clinic ADHD care plus the Quotient®~Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers."
78533|NCT02094612|B1|Baseline|Usual Care|"Usual clinic ADHD care~Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic"
78534|NCT02094612|P2|Participant Flow|Usual Care Plus Assessment|"Usual clinic ADHD care plus the Quotient®~Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers."
78535|NCT02094612|P1|Participant Flow|Usual Care|"Usual clinic ADHD care~Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic"
78536|NCT02094612|O2|Outcome|Usual Care Plus Assessment|"Usual clinic ADHD care plus the Quotient®~Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers."
78537|NCT02094612|O1|Outcome|Usual Care|"Usual clinic ADHD care~Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic"
78538|NCT02094612|O2|Outcome|Usual Care Plus Assessment|"Usual clinic ADHD care plus the Quotient®~Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers."
78539|NCT02094612|O1|Outcome|Usual Care|"Usual clinic ADHD care~Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic"
78540|NCT02094612|O2|Outcome|Usual Care Plus Assessment|"Usual clinic ADHD care plus the Quotient®~Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers."
78541|NCT02094612|O1|Outcome|Usual Care|"Usual clinic ADHD care~Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic"
78542|NCT02094612|O2|Outcome|Usual Care Plus Assessment|"Usual clinic ADHD care plus the Quotient®~Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers."
78543|NCT02094612|O1|Outcome|Usual Care|"Usual clinic ADHD care~Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic"
78544|NCT02094612|O2|Outcome|Usual Care Plus Assessment|"Usual clinic ADHD care plus the Quotient®~Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers."
78545|NCT02094612|O1|Outcome|Usual Care|"Usual clinic ADHD care~Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic"
78546|NCT02094612|O2|Outcome|Usual Care Plus Assessment|"Usual clinic ADHD care plus the Quotient®~Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers."
78547|NCT02094612|O1|Outcome|Usual Care|"Usual clinic ADHD care~Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic"
78548|NCT02094612|O2|Outcome|Usual Care Plus Assessment|"Usual clinic ADHD care plus the Quotient®~Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers."
78549|NCT02094612|O1|Outcome|Usual Care|"Usual clinic ADHD care~Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic"
78550|NCT02094612|E2|Reported Event|Usual Care Plus Assessment|"Usual clinic ADHD care plus the Quotient®~Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers."
78551|NCT02094612|E1|Reported Event|Usual Care|"Usual clinic ADHD care~Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic"
78552|NCT02094573|B3|Baseline|Total|Total of all reporting groups
78553|NCT02094573|B2|Baseline|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
78554|NCT02094573|B1|Baseline|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
78555|NCT02094573|P2|Participant Flow|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
78556|NCT02094573|P1|Participant Flow|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
78557|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
78558|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
78559|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
78560|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
78561|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
78562|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
78563|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
78564|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
78565|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
78566|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
78567|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
78568|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
78569|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
78570|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
78571|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
78572|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
78573|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
78574|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
78575|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
78576|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
78577|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
78578|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
78579|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
78580|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
78581|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
78582|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
78583|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
78584|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
78585|NCT02094573|E2|Reported Event|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
78586|NCT02094573|E1|Reported Event|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
78587|NCT02094534|B3|Baseline|Total|Total of all reporting groups
78588|NCT02094534|B2|Baseline|Placebo|Fish oil in capsules, identical in appearance to ORMD-0801
78589|NCT02094534|B1|Baseline|ORMD-0801|"API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules, ORMD-0801~ORMD-0801 capsules: API (recombinant human insulin USP), in Oramed’s proprietary formulation in capsules."
78590|NCT02094534|P2|Participant Flow|Placebo|Fish oil in capsules, identical in appearance to ORMD-0801
78591|NCT02094534|P1|Participant Flow|ORMD-0801|"API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules, ORMD-0801~ORMD-0801 capsules: API (recombinant human insulin USP), in Oramed’s proprietary formulation in capsules."
78592|NCT02094534|O2|Outcome|Placebo|Fish oil in capsules, identical in appearance to ORMD-0801
78593|NCT02094534|O1|Outcome|ORMD-0801|"API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules, ORMD-0801~ORMD-0801 capsules: API (recombinant human insulin USP), in Oramed’s proprietary formulation in capsules."
78594|NCT02094534|O2|Outcome|Placebo|Fish oil in capsules, identical in appearance to ORMD-0801
78595|NCT02094534|O1|Outcome|ORMD-0801|"API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules, ORMD-0801~ORMD-0801 capsules: API (recombinant human insulin USP), in Oramed’s proprietary formulation in capsules."
78596|NCT02094534|E2|Reported Event|Placebo|Fish oil in capsules, identical in appearance to ORMD-0801
78597|NCT02094534|E1|Reported Event|ORMD-0801|"API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules, ORMD-0801~ORMD-0801 capsules: API (recombinant human insulin USP), in Oramed’s proprietary formulation in capsules."
78598|NCT02094443|B3|Baseline|Total|Total of all reporting groups
78599|NCT02094443|B2|Baseline|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
78600|NCT02094443|B1|Baseline|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
78601|NCT02094443|P2|Participant Flow|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
78602|NCT02094443|P1|Participant Flow|Alisporivir 300 mg BID|Alisporivir (ALV) 300 mg twice per day (BID) with ribavirin (RBV) for up to 24 weeks.
78603|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
78604|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
78605|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
78606|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
78607|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
78608|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
78609|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
78610|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
78611|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
78612|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
78613|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
78614|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
78615|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
78616|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
78617|NCT02094443|E2|Reported Event|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
78618|NCT02094443|E1|Reported Event|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
78619|NCT02094352|B3|Baseline|Total|Total of all reporting groups
78620|NCT02094352|B2|Baseline|Control Group + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.~Outpatient: Patients will receive three saline booster infusions over the course of three months.~Control Group + Epidural infusion: The saline and epidural infusions will be administered over 96 hours with appropriate titration.~Control Group Booster Infusion: Patients will receive three saline booster infusions over the course of three months."
78674|NCT02093949|O2|Outcome|Historical Control|The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach.
78621|NCT02094352|B1|Baseline|Ketamine Infusion + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.~Outpatient: Patients will receive three ketamine booster infusions over the course of three months.~Ketamine Infusion + Epidural Infusion: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.~Ketamine Booster Infusion: Patients will receive three ketamine booster infusions over the course of three months."
78622|NCT02094352|P2|Participant Flow|Control Group + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.~Outpatient: Patients will receive three saline booster infusions over the course of three months.~Control Group + Epidural infusion: The saline and epidural infusions will be administered over 96 hours with appropriate titration.~Control Group Booster Infusion: Patients will receive three saline booster infusions over the course of three months."
78623|NCT02094352|P1|Participant Flow|Ketamine Infusion + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.~Outpatient: Patients will receive three ketamine booster infusions over the course of three months.~Ketamine Infusion + Epidural Infusion: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.~Ketamine Booster Infusion: Patients will receive three ketamine booster infusions over the course of three months."
78624|NCT02094352|O2|Outcome|Control Group + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.~Outpatient: Patients will receive three saline booster infusions over the course of three months.~Control Group + Epidural infusion: The saline and epidural infusions will be administered over 96 hours with appropriate titration.~Control Group Booster Infusion: Patients will receive three saline booster infusions over the course of three months."
78625|NCT02094352|O1|Outcome|Ketamine Infusion + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.~Outpatient: Patients will receive three ketamine booster infusions over the course of three months.~Ketamine Infusion + Epidural Infusion: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.~Ketamine Booster Infusion: Patients will receive three ketamine booster infusions over the course of three months."
78626|NCT02094352|E2|Reported Event|Control Group + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.~Outpatient: Patients will receive three saline booster infusions over the course of three months.~Control Group + Epidural infusion: The saline and epidural infusions will be administered over 96 hours with appropriate titration.~Control Group Booster Infusion: Patients will receive three saline booster infusions over the course of three months."
78627|NCT02094352|E1|Reported Event|Ketamine Infusion + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.~Outpatient: Patients will receive three ketamine booster infusions over the course of three months.~Ketamine Infusion + Epidural Infusion: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.~Ketamine Booster Infusion: Patients will receive three ketamine booster infusions over the course of three months."
78628|NCT02094326|B1|Baseline|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
78629|NCT02094326|P1|Participant Flow|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
78630|NCT02094326|O1|Outcome|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
78631|NCT02094326|O1|Outcome|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
78632|NCT02094326|O1|Outcome|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
78633|NCT02094326|O1|Outcome|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
78634|NCT02094326|O1|Outcome|Patients Whom Fulfilled the ACR|Patients whom fulfilled the classification of rheumatoid arthritis (ACR) 2010 criteria from 2008 to 2012, and initiated on at least one disease-modifying antirheumatic drug (DMARD) during this period.
78635|NCT02094326|O1|Outcome|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
78636|NCT02094326|E1|Reported Event|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
78637|NCT02094300|B1|Baseline|Zenith® Dissection Endovascular Graft|The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.
78638|NCT02094300|P1|Participant Flow|Zenith® Dissection Endovascular Graft|The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.
78639|NCT02094300|O1|Outcome|Zenith® Dissection Endovascular Graft|The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.
78640|NCT02094300|E1|Reported Event|Zenith® Dissection Endovascular Graft|The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.
78641|NCT02094261|B1|Baseline|AZD9291 80mg|Daily single dose of AZD9291 80mg
78642|NCT02094261|P1|Participant Flow|AZD9291 80mg|Daily single dose of AZD9291 80mg
78643|NCT02094261|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
78644|NCT02094261|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
78645|NCT02094261|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
78649|NCT02093962|B2|Baseline|Placebo and Pemetrexed|"Matching placebo in combination with pemetrexed~Matched placebo in combination with pemetrexed: Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.~Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration."
78650|NCT02093962|B1|Baseline|TH-302 and Pemetrexed|"TH-302 in combination with pemetrexed~TH-302 combination with pemetrexed: 400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.~Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration."
78651|NCT02093962|P2|Participant Flow|Placebo and Pemetrexed|"Matching placebo in combination with pemetrexed~Matched placebo in combination with pemetrexed: Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.~Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration."
78652|NCT02093962|P1|Participant Flow|TH-302 and Pemetrexed|"TH-302 in combination with pemetrexed~TH-302 combination with pemetrexed: 400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.~Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration."
78653|NCT02093962|O2|Outcome|Placebo and Pemetrexed|"Matching placebo in combination with pemetrexed~Matched placebo in combination with pemetrexed: Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.~Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration."
78654|NCT02093962|O1|Outcome|TH-302 and Pemetrexed|"TH-302 in combination with pemetrexed~TH-302 combination with pemetrexed: 400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.~Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration."
78655|NCT02093962|E2|Reported Event|Placebo and Pemetrexed|"Matching placebo in combination with pemetrexed~Matched placebo in combination with pemetrexed: Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.~Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration."
78656|NCT02093962|E1|Reported Event|TH-302 and Pemetrexed|"TH-302 in combination with pemetrexed~TH-302 combination with pemetrexed: 400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.~Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration."
78657|NCT02093949|B3|Baseline|Total|Total of all reporting groups
78658|NCT02093949|B2|Baseline|Historical Control|Validation set (n=47) The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach
78659|NCT02093949|B1|Baseline|Substrate Ablation|Study population (n=105) Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation.
78660|NCT02093949|P2|Participant Flow|Historical Control|The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach
78661|NCT02093949|P1|Participant Flow|Substrate Ablation|Between September 2013 and July 2014, 105 patients with AF were prospectively enrolled at three centers performing substrate ablation (without pulmonary vein isolation) routinely
78662|NCT02093949|O1|Outcome|Substrate Ablation|Study population (n=105) Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation
78663|NCT02093949|O1|Outcome|Substrate Ablation|Study population (n=105) Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation
78664|NCT02093949|O2|Outcome|Historical Control|Validation set (n=47) The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach
78665|NCT02093949|O1|Outcome|Substrate Ablation|Study population (n=105) Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation.
78666|NCT02093949|O2|Outcome|Historical Control Long Term Follow-up|Population at the end of follow up : 3 patients dropped out during the blanking period (1 died of heart failure and 2 relocated)
78667|NCT02093949|O1|Outcome|Substrate Ablation Long Term Follow-up|"Out of the 105 patients included in the substrate ablation arm, only 96 were included in the long term follow-up group.~9 patients (8.6%) did not complete the follow up: 1 patient died 2 months before the end of follow-up (myocardial infarction) and 8 were lost to follow-up because of relocation."
78668|NCT02093949|O2|Outcome|Historical Control Long Term Follow-up|"Out of the 47 patients included in the validation set arm, only 42 finished the 18-mlonth follow-up. 2 patients were lost to follow-up~Population at the end of follow up : 3 patients dropped out during the blanking period (1 died of heart failure and 2 relocated)"
78669|NCT02093949|O1|Outcome|Substrate Ablation Long Term Follow Up|"Out of the 105 patients included in the substrate ablation arm, only 96 were included in the long term follow-up group.~9 patients (8.6%) did not complete the follow up: 1 patient died 2 months before the end of follow-up (myocardial infarction) and 8 were lost to follow-up because of relocation."
78670|NCT02093949|O2|Outcome|Historical Control|The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach.
78671|NCT02093949|O1|Outcome|Substrate Ablation|Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation
78672|NCT02093949|O2|Outcome|Historical Control|Validation set (n=47) The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach.
78673|NCT02093949|O1|Outcome|Substrate Ablation|Study population (n=105) Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation
78675|NCT02093949|O1|Outcome|Substrate Ablation|Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation
78676|NCT02093949|E2|Reported Event|Historical Control|Validation set (n=47)
78677|NCT02093949|E1|Reported Event|Substrate Ablation|Study population (n=105)
78678|NCT02093923|B6|Baseline|Total|Total of all reporting groups
78679|NCT02093923|B5|Baseline|Placebo|Placebo administered twice, two weeks apart
78680|NCT02093923|B4|Baseline|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
78681|NCT02093923|B3|Baseline|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
78682|NCT02093923|B2|Baseline|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
78683|NCT02093923|B1|Baseline|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
78684|NCT02093923|P5|Participant Flow|Placebo|Placebo administered twice, two weeks apart
78685|NCT02093923|P4|Participant Flow|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
78686|NCT02093923|P3|Participant Flow|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
78687|NCT02093923|P2|Participant Flow|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
78688|NCT02093923|P1|Participant Flow|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
78689|NCT02093923|O4|Outcome|Placebo|Placebo administered twice, two weeks apart
78690|NCT02093923|O3|Outcome|DX-2930, Combined Dose Level 3 and Dose Level 4|This arm includes the total subjects analysed for Dose level 3 and Dose level 4 combined.
78691|NCT02093923|O2|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
78692|NCT02093923|O1|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
78693|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
78694|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
78695|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
78696|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
78697|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
78698|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
78699|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
78700|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
78701|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
78702|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
78703|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
78704|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
78705|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
78706|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
78707|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
78708|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
78709|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
78710|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
78711|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
78712|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
78713|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
78714|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
78715|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
78716|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
78717|NCT02093923|O5|Outcome|Placebo|Placebo administered twice, two weeks apart
78718|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
78719|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
78720|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
78721|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
78722|NCT02093923|O5|Outcome|Placebo|Placebo administered twice, two weeks apart
78723|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
78724|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
78725|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
78726|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
78727|NCT02093923|O5|Outcome|Placebo|Placebo administered twice, two weeks apart
78728|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
78729|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
78730|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
78731|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
78732|NCT02093923|O5|Outcome|Placebo|Placebo administered twice, two weeks apart
78733|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
78734|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
78735|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
78738|NCT02093923|E4|Reported Event|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
78739|NCT02093923|E3|Reported Event|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
78740|NCT02093923|E2|Reported Event|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
78741|NCT02093923|E1|Reported Event|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
78742|NCT02093897|B1|Baseline|rVIII-SingleChain|Subjects were assigned to either an on-demand or prophylaxis regimen and received rVIII-SingleChain as an IV infusion. Subjects assigned to a prophylaxis regimen were treated with 15 to 50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based on available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose for on-demand treatment of a bleeding episode was based on the recommendations of the WFH, with a minimum dose of 15 IU/kg. All subjects were to be treated for a minimum of 50 EDs. For the PK evaluation, the subjects received a single IV dose of 50 IU/kg of rVIII-SingleChain on Day 1 at the start of the PK evaluation period.
78743|NCT02093897|P1|Participant Flow|rVIII-SingleChain|Subjects were assigned to either an on-demand or prophylaxis regimen and received rVIII-SingleChain as an intravenous (IV) infusion. Subjects assigned to a prophylaxis regimen were treated with 15 to 50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based on available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose for on-demand treatment of a bleeding episode was based on the recommendations of the World Federation of Hemophilia (WFH), with a minimum dose of 15 IU/kg. All subjects were to be treated for a minimum of 50 EDs. For the PK evaluation, the subjects received a single IV dose of 50 IU/kg of rVIII-SingleChain on Day 1 at the start of the PK evaluation period.
78744|NCT02093897|O1|Outcome|rVIII-SingleChain|Subjects were assigned to either an on-demand or prophylaxis regimen and received rVIII-SingleChain as an IV infusion. Subjects assigned to a prophylaxis regimen were treated with 15 to 50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based on available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose for on-demand treatment of a bleeding episode was based on the recommendations of the WFH, with a minimum dose of 15 IU/kg. All subjects were to be treated for a minimum of 50 EDs. For the PK evaluation, the subjects received a single IV dose of 50 IU/kg of rVIII-SingleChain on Day 1 at the start of the PK evaluation period.
78745|NCT02093897|O1|Outcome|Pharmacokinetic Population|The PK Population comprised those subjects who participated in the PK assessment and received at least 1 dose of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile of rVIII-SingleChain.
78746|NCT02093897|O1|Outcome|Pharmacokinetic Population|The PK Population comprised those subjects who participated in the PK assessment and received at least 1 dose of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile of rVIII-SingleChain.
78747|NCT02093897|O1|Outcome|Pharmacokinetic Population|The PK Population comprised those subjects who participated in the PK assessment and received at least 1 dose of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile of rVIII-SingleChain.
78748|NCT02093897|O1|Outcome|Pharmacokinetic Population|The Pharmacokinetic (PK) Population comprised those subjects who participated in the PK assessment and received at least 1 dose of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile of rVIII-SingleChain.
78749|NCT02093897|O1|Outcome|On-demand|"Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
78750|NCT02093897|O1|Outcome|On-demand|"Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
78751|NCT02093897|O2|Outcome|Prophylaxis|"Subjects receiving routine prophylaxis treatment were initially treated with 15-50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based upon available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose or dosing frequency may have been adjusted if necessary. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
78752|NCT02093897|O1|Outcome|On-demand|"Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
78753|NCT02093897|O2|Outcome|Prophylaxis|"Subjects receiving routine prophylaxis treatment were initially treated with 15-50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based upon available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose or dosing frequency may have been adjusted if necessary. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
78776|NCT02093819|P3|Participant Flow|BI 416970 25mg|The medication was administered as a single oral dose (Dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
80480|NCT02081690|O1|Outcome|Macitentan|Macitentan tablet, dose of 10 mg, once daily
78754|NCT02093897|O1|Outcome|On-demand|"Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
78755|NCT02093897|O2|Outcome|Prophylaxis|"Subjects receiving routine prophylaxis treatment were initially treated with 15-50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based upon available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose or dosing frequency may have been adjusted if necessary. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
78756|NCT02093897|O1|Outcome|On-demand|"Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
78757|NCT02093897|O1|Outcome|Efficacy Population|The Efficacy Population consisted of all subjects who received at least 1 dose of rVIII-SingleChain as part of either a routine prophylaxis or on-demand regimen during the study. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).
78758|NCT02093897|O2|Outcome|Prophylaxis|Subjects receiving routine prophylaxis treatment were initially treated with 15-50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based upon available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose or dosing frequency may have been adjusted if necessary.
78759|NCT02093897|O1|Outcome|On-demand|Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions.
78760|NCT02093897|O1|Outcome|Efficacy Population|The Efficacy Population consisted of all subjects who received at least 1 dose of rVIII-SingleChain as part of either a routine prophylaxis or on-demand regimen during the study. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).
78761|NCT02093897|E1|Reported Event|rVIII-SingleChain|Subjects were assigned to either an on-demand or prophylaxis regimen and received rVIII-SingleChain as an IV infusion. Subjects assigned to a prophylaxis regimen were treated with 15 to 50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based on available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose for on-demand treatment of a bleeding episode was based on the recommendations of the WFH, with a minimum dose of 15 IU/kg. All subjects were to be treated for a minimum of 50 EDs. For the PK evaluation, the subjects received a single IV dose of 50 IU/kg of rVIII-SingleChain on Day 1 at the start of the PK evaluation period.
78762|NCT02093819|B9|Baseline|Total|Total of all reporting groups
78763|NCT02093819|B8|Baseline|BI 416970 600mg|The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78764|NCT02093819|B7|Baseline|BI 416970 400mg|The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78765|NCT02093819|B6|Baseline|BI 416970 200mg|The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78766|NCT02093819|B5|Baseline|BI 416970 100mg|The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78767|NCT02093819|B4|Baseline|BI 416970 50mg|The medication was administered as a single oral dose (dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78768|NCT02093819|B3|Baseline|BI 416970 25mg|The medication was administered as a single oral dose (Dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78769|NCT02093819|B2|Baseline|BI 416970 10mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78770|NCT02093819|B1|Baseline|Placebo|The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78771|NCT02093819|P8|Participant Flow|BI 416970 600mg|The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78772|NCT02093819|P7|Participant Flow|BI 416970 400mg|The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78773|NCT02093819|P6|Participant Flow|BI 416970 200mg|The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78774|NCT02093819|P5|Participant Flow|BI 416970 100mg|The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78775|NCT02093819|P4|Participant Flow|BI 416970 50mg|The medication was administered as a single oral dose (dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78974|NCT02093221|O3|Outcome|90 mg/kg/wk Alpha1-PI, 26 Weeks|"90 mg/kg weekly infusions of Alpha1-PI for 26 weeks.~90 mg/kg Alpha1-PI"
78777|NCT02093819|P2|Participant Flow|BI 416970 10mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78778|NCT02093819|P1|Participant Flow|Placebo|The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78779|NCT02093819|O7|Outcome|BI 416970 600mg|The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78780|NCT02093819|O6|Outcome|BI 416970 400mg|The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78781|NCT02093819|O5|Outcome|BI 416970 200mg|The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78782|NCT02093819|O4|Outcome|BI 416970 100mg|The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78783|NCT02093819|O3|Outcome|BI 416970 50mg|The medication was administered as a single oral dose (Dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78784|NCT02093819|O2|Outcome|BI 416970 25mg|The medication was administered as a single oral dose (dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78785|NCT02093819|O1|Outcome|BI 416970 10mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78786|NCT02093819|O7|Outcome|BI 416970 600mg|The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78787|NCT02093819|O6|Outcome|BI 416970 400mg|The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78788|NCT02093819|O5|Outcome|BI 416970 200mg|The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78789|NCT02093819|O4|Outcome|BI 416970 100mg|The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78790|NCT02093819|O3|Outcome|BI 416970 50mg|The medication was administered as a single oral dose (Dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78791|NCT02093819|O2|Outcome|BI 416970 25mg|The medication was administered as a single oral dose (dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78792|NCT02093819|O1|Outcome|BI 416970 10mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78793|NCT02093819|O8|Outcome|BI 416970 600mg|The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78794|NCT02093819|O7|Outcome|BI 416970 400mg|The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78795|NCT02093819|O6|Outcome|BI 416970 200mg|The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78796|NCT02093819|O5|Outcome|BI 416970 100mg|The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78797|NCT02093819|O4|Outcome|BI 416970 50mg|The medication was administered as a single oral dose (dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78798|NCT02093819|O3|Outcome|BI 416970 25mg|The medication was administered as a single oral dose (Dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78799|NCT02093819|O2|Outcome|BI 416970 10mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78800|NCT02093819|O1|Outcome|Placebo|The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h
78801|NCT02093819|E10|Reported Event|Total Treatment|All patients affected by AEs during entire treatment period.
78802|NCT02093819|E9|Reported Event|Total BI 416970 Treatment|All patients affected by AEs during administration of BI 416970 medication .
78803|NCT02093819|E8|Reported Event|BI 416970 600 mg|The medication was administered as a single oral dose (dose = 600 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78804|NCT02093819|E7|Reported Event|BI 416970 400 mg|The medication was administered as a single oral dose (dose = 400 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78805|NCT02093819|E6|Reported Event|BI 416970 200 mg|The medication was administered as a single oral dose (dose = 200 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78806|NCT02093819|E5|Reported Event|BI 416970 100 mg|The medication was administered as a single oral dose (dose = 100 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78807|NCT02093819|E4|Reported Event|BI 416970 50 mg|The medication was administered as a single oral dose (dose = 50 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78808|NCT02093819|E3|Reported Event|BI 416970 25 mg|The medication was administered as a single oral dose (dose = 25 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78809|NCT02093819|E2|Reported Event|BI 416970 10 mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78810|NCT02093819|E1|Reported Event|Placebo|The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
78811|NCT02093702|B3|Baseline|Total|Total of all reporting groups
78812|NCT02093702|B2|Baseline|Structured PA Education Program for People With T2DM|Subjects in the experimental arm (n = 3) participated in a structured PA education program for people with T2DM.
78813|NCT02093702|B1|Baseline|Standard PA Education for People With T2DM (From a CDE)|Subjects in the control arm (n = 2) received the standard approach to PA education from a Canadian Certified Diabetes Educator (CDE).
78814|NCT02093702|P2|Participant Flow|Structured PA Education Program for People With T2DM|Subjects in the experimental arm (n = 3) participated in a structured PA education program for people with T2DM.
78815|NCT02093702|P1|Participant Flow|Standard PA Education for People With T2DM (From a CDE)|Subjects in the control arm (n = 2) received the standard approach to PA education from a Canadian Certified Diabetes Educator (CDE).
78816|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
78817|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
78818|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
78819|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
78820|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
78821|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
78822|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
78823|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
78824|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
78825|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
78826|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
78827|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
78828|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
78829|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
78830|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
78831|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
78832|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
78833|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
78834|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
78835|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
78836|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
78837|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
78838|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
78975|NCT02093221|O2|Outcome|180 mg/kg/wk Alpha1-PI, 13 Weeks|"180 mg/kg weekly infusions of Alpha1-PI for 13 weeks.~180 mg/kg Alpha1-PI"
78839|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
78840|NCT02093702|E2|Reported Event|Standard PA Education for People With T2DM (From a CDE)|Group of subjects receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
78841|NCT02093702|E1|Reported Event|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
78842|NCT02093689|B4|Baseline|Total|Total of all reporting groups
78843|NCT02093689|B3|Baseline|Part 2 Placebo|Placebo contains 20mM sodium citrate diluted in BSS and administered as irrigation solutions.
78844|NCT02093689|B2|Baseline|Part 2 OMS302|OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution
78845|NCT02093689|B1|Baseline|Part 1 OMS302|OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution
78846|NCT02093689|P3|Participant Flow|Part 2 Placebo|Placebo contains 20mM sodium citrate diluted in BSS and administered as irrigation solutions.
78847|NCT02093689|P2|Participant Flow|Part 2 OMS302|OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution
78848|NCT02093689|P1|Participant Flow|Part 1 OMS302|OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution
78849|NCT02093689|O3|Outcome|Part 2 Placebo|Placebo contains 20mM sodium citrate diluted in BSS and administered as irrigation solution.
78850|NCT02093689|O2|Outcome|Part 2 OMS302|OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution
78851|NCT02093689|O1|Outcome|Part 1 OMS302|OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution
78852|NCT02093689|E1|Reported Event|Part 1 OMS302|OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution
78853|NCT02093520|B3|Baseline|Total|Total of all reporting groups
78854|NCT02093520|B2|Baseline|Epidural Steroid Injection (ESI)|"An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.~Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
78855|NCT02093520|B1|Baseline|MILD|"Image guided minimally-invasive lumbar decompression~Minimally Invasive Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
78856|NCT02093520|P2|Participant Flow|Epidural Steroid Injection (ESI)|"An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.~Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
78857|NCT02093520|P1|Participant Flow|Minimally Invasive Lumbar Decompression (MILD)|"Image guided minimally-invasive lumbar decompression~Minimally Invasive Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
78858|NCT02093520|O2|Outcome|Epidural Steroid Injection (ESI)|"An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.~Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
78859|NCT02093520|O1|Outcome|Minimally Invasive Lumbar Decompression (MILD)|"Image guided minimally-invasive lumbar decompression~Minimally Invasive Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
78860|NCT02093520|O2|Outcome|Epidural Steroid Injection (ESI)|"An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.~Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
78861|NCT02093520|O1|Outcome|Minimally Invasive Lumbar Decompression (MILD)|"Image guided minimally-invasive lumbar decompression~Minimally Invasive Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
78862|NCT02093520|O2|Outcome|Epidural Steroid Injection (ESI)|"An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.~Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
78863|NCT02093520|O1|Outcome|Minimally Invasive Lumbar Decompression (MILD)|"Image guided minimally-invasive lumbar decompression~Minimally Invasive Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
78864|NCT02093520|E2|Reported Event|Epidural Steroid Injection (ESI)|"An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.~Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
78865|NCT02093520|E1|Reported Event|Minimally Invasive Lumbar Decompression (MILD)|"Image guided minimally-invasive lumbar decompression~Minimally Invasive Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
78866|NCT02093390|B3|Baseline|Total|Total of all reporting groups
78867|NCT02093390|B2|Baseline|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
78868|NCT02093390|B1|Baseline|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
78912|NCT02093351|O2|Outcome|Cohort 3 - Olaparib + Letrozole (Treatment Period 3)|Patients in Cohort 3 received letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 39 to Day 43. Blood sampling for PK analysis was taken on Day 43.
78869|NCT02093390|P2|Participant Flow|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on Days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on Day 10 then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
78870|NCT02093390|P1|Participant Flow|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on Day 10 then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
78871|NCT02093390|O1|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
78872|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
78873|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
78874|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
78875|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
78876|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
78877|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
78878|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
78879|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
78880|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
78881|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
78882|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
78883|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
78884|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
78885|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
78886|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
78887|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
78888|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
78889|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
78971|NCT02093221|P1|Participant Flow|Alpha1-PI 180 mg/kg/wk, 26 Weeks|"180 mg/kg weekly infusions of Alpha1-PI for 26 weeks.~180 mg/kg Alpha1-PI"
79035|NCT02092961|O1|Outcome|FOSTA 100 MG PO BID|Dosing Group A
78890|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
78891|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
78892|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
78893|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
78894|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
78895|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
78896|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
78897|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
78898|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
78899|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
78900|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
78901|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
78902|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
78903|NCT02093390|E2|Reported Event|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
78904|NCT02093390|E1|Reported Event|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
78905|NCT02093351|B4|Baseline|Total|Total of all reporting groups
78906|NCT02093351|B3|Baseline|Cohort 3 - Letrozole|Patients in Cohort 3 received olaparib 300 mg bd for 5 days in Treatment Period 1; letrozole 2.5 mg od for 29 days in Treatment Period 2; and letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
78907|NCT02093351|B2|Baseline|Cohort 2 - Anastrozole|Patients in Cohort 2 received olaparib 300 mg bd for 5 days in Treatment Period 1; anastrozole 1 mg od for 10 days in Treatment Period 2; and anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
78908|NCT02093351|B1|Baseline|Cohort 1 - Tamoxifen|Patients in Cohort 1 received olaparib 300 mg twice daily (bd) for 5 days in Treatment Period 1; tamoxifen 60 mg once daily (od) (loading dose) for 4 days then 20 mg od for 13 days (maintenance dose) in Treatment Period 2; and tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
78909|NCT02093351|P3|Participant Flow|Cohort 3 - Letrozole|Patients in Cohort 3 received olaparib 300 mg bd for 5 days in Treatment Period 1; letrozole 2.5 mg od for 29 days in Treatment Period 2; and letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
78910|NCT02093351|P2|Participant Flow|Cohort 2 - Anastrozole|Patients in Cohort 2 received olaparib 300 mg bd for 5 days in Treatment Period 1; anastrozole 1 mg od for 10 days in Treatment Period 2; and anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
78911|NCT02093351|P1|Participant Flow|Cohort 1 - Tamoxifen|Patients in Cohort 1 received olaparib 300 mg twice daily (bd) for 5 days in Treatment Period 1; tamoxifen 60 mg once daily (od) (loading dose) for 4 days then 20 mg od for 13 days (maintenance dose) in Treatment Period 2; and tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
78972|NCT02093221|O5|Outcome|Placebo|"Weekly infusions of placebo for 13 or 26 weeks.~Placebo"
79036|NCT02092961|O3|Outcome|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
78913|NCT02093351|O1|Outcome|Cohort 3 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
78914|NCT02093351|O2|Outcome|Cohort 3 - Olaparib + Letrozole (Treatment Period 3)|Patients in Cohort 3 received letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 39 to Day 43. Blood sampling for PK analysis was taken on Day 43.
78915|NCT02093351|O1|Outcome|Cohort 3 - Letrozole Alone (Treatment Period 2)|Patients in Cohort 3 received letrozole 2.5 mg od from Day 10 to Day 38. Blood sampling for PK analysis was taken on Day 38.
78916|NCT02093351|O2|Outcome|Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)|Patients in Cohort 2 received anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 20 to Day 24. Blood sampling for PK analysis was taken on Day 24.
78917|NCT02093351|O1|Outcome|Cohort 2 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
78918|NCT02093351|O2|Outcome|Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)|Patients in Cohort 2 received anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 20 to Day 24. Blood sampling for PK analysis was taken on Day 24.
78919|NCT02093351|O1|Outcome|Cohort 2 - Anastrozole Alone (Treatment Period 2)|Patients in Cohort 2 received anastrozole 1 mg od from Day 10 to Day 19. Blood sampling for PK analysis was taken on Day 19.
78920|NCT02093351|O2|Outcome|Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)|Patients in Cohort 1 received tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 27 to Day 31. Blood sampling for PK analysis was taken on Day 31.
78921|NCT02093351|O1|Outcome|Cohort 1 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
78922|NCT02093351|O2|Outcome|Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)|Patients in Cohort 1 received tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 27 to Day 31. Blood sampling for PK analysis was taken on Day 31.
78923|NCT02093351|O1|Outcome|Cohort 1 - Tamoxifen Alone (Treatment Period 2)|Patients in Cohort 1 received tamoxifen 60 mg od from Day 10 to Day 13 (loading dose). From Day 14 to Day 26 patients received tamoxifen 20 mg od (maintenance dose). Blood sampling for PK analysis was taken on Day 26.
78924|NCT02093351|O2|Outcome|Cohort 3 - Olaparib + Letrozole (Treatment Period 3)|Patients in Cohort 3 received letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 39 to Day 43. Blood sampling for PK analysis was taken on Day 43.
78925|NCT02093351|O1|Outcome|Cohort 3 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
78926|NCT02093351|O2|Outcome|Cohort 3 - Olaparib + Letrozole (Treatment Period 3)|Patients in Cohort 3 received letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 39 to Day 43. Blood sampling for PK analysis was taken on Day 43.
78927|NCT02093351|O1|Outcome|Cohort 3 - Letrozole Alone (Treatment Period 2)|Patients in Cohort 3 received letrozole 2.5 mg od from Day 10 to Day 38. Blood sampling for PK analysis was taken on Day 38.
78928|NCT02093351|O2|Outcome|Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)|Patients in Cohort 2 received anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 20 to Day 24. Blood sampling for PK analysis was taken on Day 24.
78929|NCT02093351|O1|Outcome|Cohort 2 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
78930|NCT02093351|O2|Outcome|Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)|Patients in Cohort 2 received anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 20 to Day 24. Blood sampling for PK analysis was taken on Day 24.
78931|NCT02093351|O1|Outcome|Cohort 2 - Anastrozole Alone (Treatment Period 2)|Patients in Cohort 2 received anastrozole 1 mg od from Day 10 to Day 19. Blood sampling for PK analysis was taken on Day 19.
78932|NCT02093351|O2|Outcome|Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)|Patients in Cohort 1 received tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 27 to Day 31. Blood sampling for PK analysis was taken on Day 31.
78933|NCT02093351|O1|Outcome|Cohort 1 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
78934|NCT02093351|O2|Outcome|Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)|Patients in Cohort 1 received tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 27 to Day 31. Blood sampling for PK analysis was taken on Day 31.
78935|NCT02093351|O1|Outcome|Cohort 1 - Tamoxifen Alone (Treatment Period 2)|Patients in Cohort 1 received tamoxifen 60 mg od from Day 10 to Day 13 (loading dose). From Day 14 to Day 26 patients received tamoxifen 20 mg od (maintenance dose). Blood sampling for PK analysis was taken on Day 26.
78936|NCT02093351|E3|Reported Event|Cohort 3 - Letrozole|Patients in Cohort 3 received olaparib 300 mg bd for 5 days in Treatment Period 1; letrozole 2.5 mg od for 29 days in Treatment Period 2; and letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
78937|NCT02093351|E2|Reported Event|Cohort 2 - Anastrozole|Patients in Cohort 2 received olaparib 300 mg bd for 5 days in Treatment Period 1; anastrozole 1 mg od for 10 days in Treatment Period 2; and anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
78938|NCT02093351|E1|Reported Event|Cohort 1 - Tamoxifen|Patients in Cohort 1 received olaparib 300 mg twice daily (bd) for 5 days in Treatment Period 1; tamoxifen 60 mg once daily (od) (loading dose) for 4 days then 20 mg od for 13 days (maintenance dose) in Treatment Period 2; and tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
78939|NCT02093234|B4|Baseline|Total|Total of all reporting groups
78940|NCT02093234|B3|Baseline|CHWs and Mobile Health Care Application|"Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application~CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application."
78973|NCT02093221|O4|Outcome|90 mg/kg/wk Alpha1-PI, 13 Weeks|"90 mg/kg weekly infusions of Alpha1-PI for 13 weeks~90 mg/kg Alpha1-PI"
78941|NCT02093234|B2|Baseline|Community Health Worker (CHW)|"CHWs assist study patients in managing there health care in various ways.~Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways."
78942|NCT02093234|B1|Baseline|Mobile Health Care Application|"Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.~mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes."
78943|NCT02093234|P3|Participant Flow|CHWs and Mobile Health Care Application|"Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application~CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application."
78944|NCT02093234|P2|Participant Flow|Community Health Worker (CHW)|"CHWs assist study patients in managing there health care in various ways.~Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways."
78945|NCT02093234|P1|Participant Flow|Mobile Health Care Application|"Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.~mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes."
78946|NCT02093234|O3|Outcome|CHWs and Mobile Health Care Application|"Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application~CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application."
78947|NCT02093234|O2|Outcome|Community Health Worker (CHW)|"CHWs assist study patients in managing there health care in various ways.~Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways."
78948|NCT02093234|O1|Outcome|Mobile Health Care Application|"Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.~mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes."
78949|NCT02093234|O3|Outcome|CHWs and Mobile Health Care Application|"Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application~CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application."
78950|NCT02093234|O2|Outcome|Community Health Worker (CHW)|"CHWs assist study patients in managing there health care in various ways.~Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways."
78951|NCT02093234|O1|Outcome|Mobile Health Care Application|"Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.~mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes."
78952|NCT02093234|O3|Outcome|CHWs and Mobile Health Care Application|"Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application~CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application."
78953|NCT02093234|O2|Outcome|Community Health Worker (CHW)|"CHWs assist study patients in managing there health care in various ways.~Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways."
78954|NCT02093234|O1|Outcome|Mobile Health Care Application|"Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.~mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes."
78955|NCT02093234|O3|Outcome|CHWs and Mobile Health Care Application|"Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application~CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application."
78956|NCT02093234|O2|Outcome|Community Health Worker (CHW)|"CHWs assist study patients in managing there health care in various ways.~Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways."
78957|NCT02093234|O1|Outcome|Mobile Health Care Application|"Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.~mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes."
78958|NCT02093234|E3|Reported Event|CHWs and Mobile Health Care Application|"Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application~CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application."
78959|NCT02093234|E2|Reported Event|Community Health Worker (CHW)|"CHWs assist study patients in managing there health care in various ways.~Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways."
78960|NCT02093234|E1|Reported Event|Mobile Health Care Application|"Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.~mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes."
78961|NCT02093221|B6|Baseline|Total|Total of all reporting groups
78962|NCT02093221|B5|Baseline|Placebo|"Weekly infusions of placebo for 13 or 26 weeks.~Placebo"
78963|NCT02093221|B4|Baseline|90 mg/kg/wk Alpha1-PI, 13 Weeks|"90 mg/kg weekly infusions of Alpha1-PI for 13 weeks~90 mg/kg Alpha1-PI"
78964|NCT02093221|B3|Baseline|90 mg/kg/wk Alpha1-PI, 26 Weeks|"90 mg/kg weekly infusions of Alpha1-PI for 26 weeks.~90 mg/kg Alpha1-PI"
78965|NCT02093221|B2|Baseline|180 mg/kg/wk Alpha1-PI, 13 Weeks|"180 mg/kg weekly infusions of Alpha1-PI for 13 weeks.~180 mg/kg Alpha1-PI"
78966|NCT02093221|B1|Baseline|Alpha1-PI 180 mg/kg/wk, 26 Weeks|"180 mg/kg weekly infusions of Alpha1-PI for 26 weeks.~180 mg/kg Alpha1-PI"
78967|NCT02093221|P5|Participant Flow|Placebo|"Weekly infusions of placebo for 13 or 26 weeks.~Placebo"
78968|NCT02093221|P4|Participant Flow|90 mg/kg/wk Alpha1-PI, 13 Weeks|"90 mg/kg weekly infusions of Alpha1-PI for 13 weeks~90 mg/kg Alpha1-PI"
78969|NCT02093221|P3|Participant Flow|90 mg/kg/wk Alpha1-PI, 26 Weeks|"90 mg/kg weekly infusions of Alpha1-PI for 26 weeks.~90 mg/kg Alpha1-PI"
78970|NCT02093221|P2|Participant Flow|180 mg/kg/wk Alpha1-PI, 13 Weeks|"180 mg/kg weekly infusions of Alpha1-PI for 13 weeks.~180 mg/kg Alpha1-PI"
78976|NCT02093221|O1|Outcome|Alpha1-PI 180 mg/kg/wk, 26 Weeks|"180 mg/kg weekly infusions of Alpha1-PI for 26 weeks.~180 mg/kg Alpha1-PI"
78977|NCT02093221|O5|Outcome|Placebo|"Weekly infusions of placebo for 13 or 26 weeks.~Placebo"
78978|NCT02093221|O4|Outcome|90 mg/kg/wk Alpha1-PI, 13 Weeks|"90 mg/kg weekly infusions of Alpha1-PI for 13 weeks~90 mg/kg Alpha1-PI"
78979|NCT02093221|O3|Outcome|90 mg/kg/wk Alpha1-PI, 26 Weeks|"90 mg/kg weekly infusions of Alpha1-PI for 26 weeks.~90 mg/kg Alpha1-PI"
78980|NCT02093221|O2|Outcome|180 mg/kg/wk Alpha1-PI, 13 Weeks|"180 mg/kg weekly infusions of Alpha1-PI for 13 weeks.~180 mg/kg Alpha1-PI"
78981|NCT02093221|O1|Outcome|Alpha1-PI 180 mg/kg/wk, 26 Weeks|"180 mg/kg weekly infusions of Alpha1-PI for 26 weeks.~180 mg/kg Alpha1-PI"
78982|NCT02093221|O5|Outcome|Placebo|"Weekly infusions of placebo for 13 or 26 weeks.~Placebo"
78983|NCT02093221|O4|Outcome|90 mg/kg/wk Alpha1-PI, 13 Weeks|"90 mg/kg weekly infusions of Alpha1-PI for 13 weeks~90 mg/kg Alpha1-PI"
78984|NCT02093221|O3|Outcome|90 mg/kg/wk Alpha1-PI, 26 Weeks|"90 mg/kg weekly infusions of Alpha1-PI for 26 weeks.~90 mg/kg Alpha1-PI"
78985|NCT02093221|O2|Outcome|180 mg/kg/wk Alpha1-PI, 13 Weeks|"180 mg/kg weekly infusions of Alpha1-PI for 13 weeks.~180 mg/kg Alpha1-PI"
78986|NCT02093221|O1|Outcome|Alpha1-PI 180 mg/kg/wk, 26 Weeks|"180 mg/kg weekly infusions of Alpha1-PI for 26 weeks.~180 mg/kg Alpha1-PI"
78987|NCT02093221|O5|Outcome|Placebo|"Weekly infusions of placebo for 13 or 26 weeks.~Placebo"
78988|NCT02093221|O4|Outcome|90 mg/kg/wk Alpha1-PI, 13 Weeks|"90 mg/kg weekly infusions of Alpha1-PI for 13 weeks~90 mg/kg Alpha1-PI"
78989|NCT02093221|O3|Outcome|90 mg/kg/wk Alpha1-PI, 26 Weeks|"90 mg/kg weekly infusions of Alpha1-PI for 26 weeks.~90 mg/kg Alpha1-PI"
78990|NCT02093221|O2|Outcome|180 mg/kg/wk Alpha1-PI, 13 Weeks|"180 mg/kg weekly infusions of Alpha1-PI for 13 weeks.~180 mg/kg Alpha1-PI"
78991|NCT02093221|O1|Outcome|Alpha1-PI 180 mg/kg/wk, 26 Weeks|"180 mg/kg weekly infusions of Alpha1-PI for 26 weeks.~180 mg/kg Alpha1-PI"
78992|NCT02093221|O5|Outcome|Placebo|"Weekly infusions of placebo for 13 or 26 weeks.~Placebo"
78993|NCT02093221|O4|Outcome|90 mg/kg/wk Alpha1-PI, 13 Weeks|"90 mg/kg weekly infusions of Alpha1-PI for 13 weeks~90 mg/kg Alpha1-PI"
78994|NCT02093221|O3|Outcome|90 mg/kg/wk Alpha1-PI, 26 Weeks|"90 mg/kg weekly infusions of Alpha1-PI for 26 weeks.~90 mg/kg Alpha1-PI"
78995|NCT02093221|O2|Outcome|180 mg/kg/wk Alpha1-PI, 13 Weeks|"180 mg/kg weekly infusions of Alpha1-PI for 13 weeks.~180 mg/kg Alpha1-PI"
78996|NCT02093221|O1|Outcome|Alpha1-PI 180 mg/kg/wk, 26 Weeks|"180 mg/kg weekly infusions of Alpha1-PI for 26 weeks.~180 mg/kg Alpha1-PI"
78997|NCT02093221|O5|Outcome|Placebo|"Weekly infusions of placebo for 13 or 26 weeks.~Placebo"
78998|NCT02093221|O4|Outcome|90 mg/kg/wk Alpha1-PI, 13 Weeks|"90 mg/kg weekly infusions of Alpha1-PI for 13 weeks~90 mg/kg Alpha1-PI"
78999|NCT02093221|O3|Outcome|90 mg/kg/wk Alpha1-PI, 26 Weeks|"90 mg/kg weekly infusions of Alpha1-PI for 26 weeks.~90 mg/kg Alpha1-PI"
79000|NCT02093221|O2|Outcome|180 mg/kg/wk Alpha1-PI, 13 Weeks|"180 mg/kg weekly infusions of Alpha1-PI for 13 weeks.~180 mg/kg Alpha1-PI"
79001|NCT02093221|O1|Outcome|Alpha1-PI 180 mg/kg/wk, 26 Weeks|"180 mg/kg weekly infusions of Alpha1-PI for 26 weeks.~180 mg/kg Alpha1-PI"
79002|NCT02093221|E5|Reported Event|Placebo|"Weekly infusions of placebo for 13 or 26 weeks.~Placebo"
79003|NCT02093221|E4|Reported Event|90 mg/kg/wk Alpha1-PI, 13 Weeks|"90 mg/kg weekly infusions of Alpha1-PI for 13 weeks~90 mg/kg Alpha1-PI"
79004|NCT02093221|E3|Reported Event|90 mg/kg/wk Alpha1-PI, 26 Weeks|"90 mg/kg weekly infusions of Alpha1-PI for 26 weeks.~90 mg/kg Alpha1-PI"
79005|NCT02093221|E2|Reported Event|180 mg/kg/wk Alpha1-PI, 13 Weeks|"180 mg/kg weekly infusions of Alpha1-PI for 13 weeks.~180 mg/kg Alpha1-PI"
79006|NCT02093221|E1|Reported Event|Alpha1-PI 180 mg/kg/wk, 26 Weeks|"180 mg/kg weekly infusions of Alpha1-PI for 26 weeks.~180 mg/kg Alpha1-PI"
79007|NCT02093026|B1|Baseline|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
79008|NCT02093026|P1|Participant Flow|Rituximab|Participants received rituximab 1 gram intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 milligrams per week (mg/week) orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid greater than or equal to (>=) 5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
79009|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
79037|NCT02092961|O2|Outcome|ADALIMUMAB 40 MG SC|Dosing Group D
79038|NCT02092961|O1|Outcome|FOSTA 100 MG PO BID|Dosing Group A
79039|NCT02092961|O3|Outcome|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
79010|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
79011|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
79012|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
79013|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
79014|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
79015|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
79016|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
79017|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
79040|NCT02092961|O2|Outcome|ADALIMUMAB 40 MG SC|Dosing Group D
79041|NCT02092961|O1|Outcome|FOSTA 100 MG PO BID|Dosing Group A
79042|NCT02092961|O3|Outcome|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
79043|NCT02092961|O2|Outcome|ADALIMUMAB 40 MG SC|Dosing Group D
79018|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
79019|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
79020|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
79021|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
79022|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
79023|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
79024|NCT02093026|E2|Reported Event|Placebo|Data for participants who received placebo in Study WA17043 or WA16291 are included in this reporting group for data collected until they received their first dose of rituximab in this study (Study WA16855). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
79025|NCT02093026|E1|Reported Event|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
79026|NCT02092961|B4|Baseline|Total|Total of all reporting groups
79027|NCT02092961|B3|Baseline|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
79028|NCT02092961|B2|Baseline|ADALIMUMAB 40 MG SC|Dosing Group D
79029|NCT02092961|B1|Baseline|FOSTA 100 MG PO BID|Dosing Group A
79030|NCT02092961|P3|Participant Flow|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
79031|NCT02092961|P2|Participant Flow|ADALIMUMAB 40 MG SC|Dosing Group D
79032|NCT02092961|P1|Participant Flow|FOSTA 100 MG PO BID|Dosing Group A
79033|NCT02092961|O3|Outcome|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
79034|NCT02092961|O2|Outcome|ADALIMUMAB 40 MG SC|Dosing Group D
79053|NCT02092857|B3|Baseline|Infant Formula Without Arachidonic Acid|10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
79054|NCT02092857|B2|Baseline|25 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
79055|NCT02092857|B1|Baseline|34 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
79056|NCT02092857|P3|Participant Flow|Infant Formula Without Arachidonic Acid|10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
79057|NCT02092857|P2|Participant Flow|25 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
79058|NCT02092857|P1|Participant Flow|34 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
79059|NCT02092857|O3|Outcome|Infant Formula Without Arachidonic Acid|10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
79060|NCT02092857|O2|Outcome|25 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
79061|NCT02092857|O1|Outcome|34 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
79062|NCT02092857|E3|Reported Event|Infant Formula Without Arachidonic Acid|10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
79063|NCT02092857|E2|Reported Event|25 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
79064|NCT02092857|E1|Reported Event|34 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
79065|NCT02092662|B3|Baseline|Total|Total of all reporting groups
79066|NCT02092662|B2|Baseline|Control|healthy volunteers
79067|NCT02092662|B1|Baseline|Study|patients after a stroke
79068|NCT02092662|P2|Participant Flow|Control|Healthy voluntiers
79069|NCT02092662|P1|Participant Flow|Patients After a Stroke|Patients who admitted to the hospital for rehabilitation after a stroke
79070|NCT02092662|O2|Outcome|Healthy Controls|"healthy age-matched voluntiers~Healthy controls: no treatment~Deltoid onset time 0.79 sec"
79071|NCT02092662|O1|Outcome|Stroke|"Stroke patients at the subacute phase~stroke: task-oriented therapy: physical and occupational therapy emphasizing integration of the patients needs, environment and context."
79072|NCT02092662|O2|Outcome|Control|Healthy age-matched
79073|NCT02092662|O1|Outcome|Study Group (T1)|Patients after a stroke
79074|NCT02092662|E1|Reported Event|Study|Patients after a stroke
79075|NCT02092649|B3|Baseline|Total|Total of all reporting groups
79076|NCT02092649|B2|Baseline|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
79077|NCT02092649|B1|Baseline|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
79078|NCT02092649|P2|Participant Flow|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
79079|NCT02092649|P1|Participant Flow|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
79080|NCT02092649|O2|Outcome|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
79081|NCT02092649|O1|Outcome|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
79082|NCT02092649|O2|Outcome|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
79083|NCT02092649|O1|Outcome|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
79084|NCT02092649|O2|Outcome|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
79085|NCT02092649|O1|Outcome|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
79086|NCT02092649|O2|Outcome|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
79087|NCT02092649|O1|Outcome|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
79088|NCT02092649|O2|Outcome|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
79089|NCT02092649|O1|Outcome|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
79090|NCT02092649|O2|Outcome|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
79091|NCT02092649|O1|Outcome|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
79092|NCT02092649|E2|Reported Event|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
79093|NCT02092649|E1|Reported Event|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
79094|NCT02092610|B3|Baseline|Total|Total of all reporting groups
79118|NCT02092441|O2|Outcome|Normal Saline Prep Pad|"normal saline prep pad~Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
79119|NCT02092441|O1|Outcome|Alcohol Prep Pad Group|"isopropyl alcohol prep pad~Alcohol prep pad group: Subjects inhale scent of alcohol pad"
79095|NCT02092610|B2|Baseline|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.~Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
79096|NCT02092610|B1|Baseline|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long~Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
79097|NCT02092610|P2|Participant Flow|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.~Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
79098|NCT02092610|P1|Participant Flow|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long~Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
79099|NCT02092610|O2|Outcome|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.~Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
79100|NCT02092610|O1|Outcome|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long~Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
79101|NCT02092610|O2|Outcome|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.~Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
79102|NCT02092610|O1|Outcome|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long~Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
79103|NCT02092610|O2|Outcome|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.~Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
79104|NCT02092610|O1|Outcome|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long~Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
79105|NCT02092610|O2|Outcome|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.~Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
79106|NCT02092610|O1|Outcome|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long~Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
79107|NCT02092610|E2|Reported Event|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.~Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
79108|NCT02092610|E1|Reported Event|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long~Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
79109|NCT02092441|B3|Baseline|Total|Total of all reporting groups
79110|NCT02092441|B2|Baseline|Normal Saline Prep Pad|"normal saline prep pad~Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
79111|NCT02092441|B1|Baseline|Alcohol Prep Pad Group|"isopropyl alcohol prep pad~Alcohol prep pad group: Subjects inhale scent of alcohol pad"
79112|NCT02092441|P2|Participant Flow|Normal Saline Prep Pad|"normal saline prep pad~Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
79113|NCT02092441|P1|Participant Flow|Alcohol Prep Pad Group|"isopropyl alcohol prep pad~Alcohol prep pad group: Subjects inhale scent of alcohol pad"
79114|NCT02092441|O2|Outcome|Normal Saline Prep Pad|"normal saline prep pad~Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
79115|NCT02092441|O1|Outcome|Alcohol Prep Pad Group|"isopropyl alcohol prep pad~Alcohol prep pad group: Subjects inhale scent of alcohol pad"
79116|NCT02092441|O2|Outcome|Normal Saline Prep Pad|"normal saline prep pad~Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
79117|NCT02092441|O1|Outcome|Alcohol Prep Pad Group|"isopropyl alcohol prep pad~Alcohol prep pad group: Subjects inhale scent of alcohol pad"
79120|NCT02092441|E2|Reported Event|Normal Saline Prep Pad|"normal saline prep pad~Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
79121|NCT02092441|E1|Reported Event|Alcohol Prep Pad Group|"isopropyl alcohol prep pad~Alcohol prep pad group: Subjects inhale scent of alcohol pad"
79122|NCT02092415|B1|Baseline|Normal Subjects|"Normal subjects, all of whom undergo brief application of junctional tourniquet~Application of a Junctional Tourniquet: All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery."
79123|NCT02092415|P1|Participant Flow|Normal Subjects|"Normal subjects, all of whom undergo brief application of junctional tourniquet~Application of a Junctional Tourniquet: All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery."
79124|NCT02092415|O2|Outcome|Normal Subjects - Tourniquet Flow|Perfusion measured at time of tourniquet placement
79125|NCT02092415|O1|Outcome|Normal Subjects Baseline Flow|"Normal subjects, all of whom undergo brief application of junctional tourniquet~Application of a Junctional Tourniquet: All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery."
79126|NCT02092415|E1|Reported Event|Normal Subjects|"Normal subjects, all of whom undergo brief application of junctional tourniquet~Application of a Junctional Tourniquet: All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery."
79127|NCT02092389|B1|Baseline|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
79128|NCT02092389|P1|Participant Flow|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
79129|NCT02092389|O1|Outcome|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
79130|NCT02092389|O1|Outcome|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
79131|NCT02092389|O1|Outcome|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
79132|NCT02092389|O1|Outcome|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
79133|NCT02092389|O1|Outcome|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
79134|NCT02092389|O1|Outcome|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
79135|NCT02092389|O1|Outcome|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
79136|NCT02092389|E1|Reported Event|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
79137|NCT02092350|B3|Baseline|Total|Total of all reporting groups
79138|NCT02092350|B2|Baseline|Deferred Treatment|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
79139|NCT02092350|B1|Baseline|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
79140|NCT02092350|P2|Participant Flow|Deferred Treatment|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a fixed dose combination (FDC) tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
79141|NCT02092350|P1|Participant Flow|Immediate Treatment + Intensive PK|Participants received grazoprevir (GZR) 100 mg tablet + elbasvir (EBR) 50 mg tablet once daily (q.d.) by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive pharmacokinetics (PK) testing.
79142|NCT02092350|O2|Outcome|Deferred Treatment Group|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
79143|NCT02092350|O1|Outcome|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
79144|NCT02092350|O2|Outcome|Deferred Treatment Group|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
79145|NCT02092350|O1|Outcome|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
79146|NCT02092350|O2|Outcome|Deferred Treatment|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
79147|NCT02092350|O1|Outcome|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
79148|NCT02092350|O2|Outcome|Deferred Treatment|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
79149|NCT02092350|O1|Outcome|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
79150|NCT02092350|O2|Outcome|Deferred Treatment|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
79151|NCT02092350|O1|Outcome|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
79152|NCT02092350|E3|Reported Event|Deferred Treatment: GZR 100 mg + EBR 50 mg 12 Weeks|Participants received a FDC tablet containing GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
79153|NCT02092350|E2|Reported Event|Deferred Treatment: GZR Placebo + EBR Placebo 12 Weeks|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks, followed by a 4-week drug-free period.
79154|NCT02092350|E1|Reported Event|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
79155|NCT02092311|B3|Baseline|Total|Total of all reporting groups
79156|NCT02092311|B2|Baseline|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
79157|NCT02092311|B1|Baseline|Combined Microscopic Varicocelectomy|Patients underwent Combined Mini-incision Microscopic Varicocelectomy
79158|NCT02092311|P2|Participant Flow|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
79159|NCT02092311|P1|Participant Flow|Combined Microscopic Varicocelectomy|Combined Mini-Incision Microscopic Varicocelectomy
79160|NCT02092311|O2|Outcome|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
79161|NCT02092311|O1|Outcome|Combined Microscopic Varicocelectomy|Patients underwent Combined Mini-incision Microscopic Varicocelectomy
79162|NCT02092311|O2|Outcome|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
79163|NCT02092311|O1|Outcome|Combined Microscopic Varicocelectomy|Patients underwent Combined Mini-incision Microscopic Varicocelectomy
79164|NCT02092311|O2|Outcome|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
79165|NCT02092311|O1|Outcome|Combined Microscopic Varicocelectomy|Patients underwent Combined Mini-incision Microscopic Varicocelectomy
79166|NCT02092311|E2|Reported Event|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
79167|NCT02092311|E1|Reported Event|Combined Microscopic Varicocelectomy|Patients underwent Combined Mini-incision Microscopic Varicocelectomy
79168|NCT02092285|B1|Baseline|Golimumab|The first induction dose of SC golimumab 200 mg was administered at Day 0. The second induction dose of SC golimumab 100 mg was administered two weeks later at Week 2. Responders at Week 6 received a maintenance dose of golimumab (50 mg for participants with a body weight <80 kg or 100 mg for participants with a body weight ≥80 kg) every 4 weeks during the Maintenance Phase for 48 weeks, yielding a total of 54 weeks treatment.
79169|NCT02092285|P1|Participant Flow|Golimumab|The first induction dose of subcutaneous (SC) golimumab 200 mg was administered at Day 0. The second induction dose of SC golimumab 100 mg was administered two weeks later at Week 2. Responders at Week 6 received a maintenance dose of golimumab (50 mg for participants with a body weight <80 kg or 100 mg for participants with a body weight ≥80 kg) every 4 weeks during the Maintenance Phase for 48 weeks, yielding a total of 54 weeks treatment.
79170|NCT02092285|O1|Outcome|Golimumab|The first induction dose of SC golimumab 200 mg was administered at Day 0. The second induction dose of SC golimumab 100 mg was administered two weeks later at Week 2. Responders at Week 6 received a maintenance dose of golimumab (50 mg for participants with a body weight <80 kg or 100 mg for participants with a body weight ≥80 kg) every 4 weeks during the Maintenance Phase for 48 weeks, yielding a total of 54 weeks treatment.
79171|NCT02092285|E1|Reported Event|Golimumab|The first induction dose of SC golimumab 200 mg was administered at Day 0. The second induction dose of SC golimumab 100 mg was administered two weeks later at Week 2. Responders at Week 6 received a maintenance dose of golimumab (50 mg for participants with a body weight <80 kg or 100 mg for participants with a body weight ≥80 kg) every 4 weeks during the Maintenance Phase for 48 weeks, yielding a total of 54 weeks treatment.
79172|NCT02092220|B1|Baseline|All Randomized Participants|All randomized participants who completed both periods of the study.
79173|NCT02092220|P2|Participant Flow|Usual Care Then Bionic Pancreas|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days in Period 1 followed by Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days in Period 2. There was a 3 to 10-day washout period between periods.
79174|NCT02092220|P1|Participant Flow|Bionic Pancreas Then Usual Care|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days in Period 1 followed by Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days in Period 2. There was a 3 to 10-day washout period between periods.
79175|NCT02092220|O2|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79176|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79177|NCT02092220|O2|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79178|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79179|NCT02092220|O2|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79180|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79181|NCT02092220|O2|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79182|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79183|NCT02092220|O2|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79184|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79185|NCT02092220|O2|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79186|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79187|NCT02092220|O2|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79188|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79189|NCT02092220|O2|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79190|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79191|NCT02092220|O2|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79192|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79193|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79194|NCT02092220|O1|Outcome|Bionic Pancreas|All randomized participants who completed both periods of the study.
79195|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79196|NCT02092220|O2|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79197|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79198|NCT02092220|O2|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79199|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79200|NCT02092220|O2|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79201|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79202|NCT02092220|O2|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79203|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79204|NCT02092220|O2|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79205|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79206|NCT02092220|O2|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79207|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79208|NCT02092220|O2|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79209|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79210|NCT02092220|O2|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79211|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79212|NCT02092220|O1|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79213|NCT02092220|O2|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79214|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79215|NCT02092220|O2|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79216|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79217|NCT02092220|O2|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79218|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79219|NCT02092220|O2|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79220|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79221|NCT02092220|O2|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79222|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79223|NCT02092220|O2|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79224|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79225|NCT02092220|O2|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79226|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79227|NCT02092220|O2|Outcome|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79228|NCT02092220|O1|Outcome|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79304|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
79305|NCT02091986|E3|Reported Event|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
79229|NCT02092220|E2|Reported Event|Usual Care|Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
79230|NCT02092220|E1|Reported Event|Bionic Pancreas|Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
79231|NCT02092168|B3|Baseline|Total|Total of all reporting groups
79232|NCT02092168|B2|Baseline|BIA 9-1067 30 mg (Once Daily) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Young Subjects"
79233|NCT02092168|B1|Baseline|BIA 9-1067 30 mg (Once Daily) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Elderly Subjects"
79234|NCT02092168|P2|Participant Flow|BIA 9-1067 30 mg (QD) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (QD) - Young Subjects"
79235|NCT02092168|P1|Participant Flow|BIA 9-1067 30 mg (QD) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (QD) - Elderly Subjects"
79236|NCT02092168|O2|Outcome|BIA 9-1067 30 mg (Once Daily) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Young Subjects"
79237|NCT02092168|O1|Outcome|BIA 9-1067 30 mg (Once Daily) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Elderly Subjects"
79238|NCT02092168|O2|Outcome|BIA 9-1067 30 mg (Once Daily) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Young Subjects"
79239|NCT02092168|O1|Outcome|BIA 9-1067 30 mg (Once Daily) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Elderly Subjects"
79240|NCT02092168|O2|Outcome|BIA 9-1067 30 mg (Once Daily) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Young Subjects"
79241|NCT02092168|O1|Outcome|BIA 9-1067 30 mg (Once Daily) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Elderly Subjects"
79242|NCT02092168|E2|Reported Event|BIA 9-1067 30 mg (Once Daily) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Young Subjects"
79243|NCT02092168|E1|Reported Event|BIA 9-1067 30 mg (Once Daily) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Elderly Subjects"
79244|NCT02092116|B3|Baseline|Total|Total of all reporting groups
79245|NCT02092116|B2|Baseline|Part B|"Pre-treatment phase of 2-4 weeks (Visit 1-Visit 2) followed by a therapeutic HIV-1 immunization phase of 12 weeks (Visit 2 to Visit 7) in which 1.2 mg Vacc-4x was administered together with 0.06 mg rhuGM-CSF at Visits 2, 3, 4, 5, 6 and 7 follow by a follow-up period of 2 weeks (Visit 8).~A viral reactivation phase of 3 weeks (Visit 9-Visit 11) consisting of one cycle of 3 romidepsin infusions (5 mg/m2) followed by a post-treatment observation phase of ~9 weeks (Visit 12-Visit 13) to assess the effect of the investigational treatment on the size of the latent HIV-1 reservoir.~A monitored antiretroviral pause of up to 16 weeks (Visit 14-Visit 33)."
79246|NCT02092116|B1|Baseline|Part A|"Pre-treatment phase of 2-4 weeks (Visit 1- Visit 2a) followed by viral reactivation phase of 3 weeks (Visit 2 to Visit 7) consisting of one cycle of romidepsin infusions at a dosing of 5 mg/m2 on days 0, 7, and 14.~Post-activation phase of ~9 weeks (Visit 8 to Visit 11) to assess the effect of romidepsin on the size of latent HIV-1 reservoir."
79247|NCT02092116|P2|Participant Flow|Part B|"Pre-treatment phase of 2-4 weeks (Visit 1-Visit 2) followed by a therapeutic HIV-1 immunization phase of 12 weeks (Visit 2 to Visit 7) in which 1.2 mg Vacc-4x was administered together with 0.06 mg rhuGM-CSF at Visits 2, 3, 4, 5, 6 and 7 follow by a follow-up period of 2 weeks (Visit 8).~A viral reactivation phase of 3 weeks (Visit 9-Visit 11) consisting of one cycle of 3 romidepsin infusions (5 mg/m2) followed by a post-treatment observation phase of ~9 weeks (Visit 12-Visit 13) to assess the effect of the investigational treatment on the size of the latent HIV-1 reservoir.~A monitored antiretroviral pause of up to 16 weeks (Visit 14-Visit 33)."
79248|NCT02092116|P1|Participant Flow|Part A|"Pre-treatment phase of 2-4 weeks (Visit 1- Visit 2a) followed by viral reactivation phase of 3 weeks (Visit 2 to Visit 7) consisting of one cycle of romidepsin infusions at a dosing of 5 mg/m2 on days 0, 7, and 14.~Post-activation phase of ~9 weeks (Visit 8 to Visit 11) to assess the effect of romidepsin on the size of latent HIV-1 reservoir."
79249|NCT02092116|O1|Outcome|Part B|"Pre-treatment phase of 2-4 weeks (Visit 1-Visit 2) followed by a therapeutic HIV-1 immunization phase of 12 weeks (Visit 2 to Visit 7) in which 1.2 mg Vacc-4x was administered together with 0.06 mg rhuGM-CSF at Visits 2, 3, 4, 5, 6 and 7 follow by a follow-up period of 2 weeks (Visit 8).~A viral reactivation phase of 3 weeks (Visit 9-Visit 11) consisting of one cycle of 3 romidepsin infusions (5 mg/m2) followed by a post-treatment observation phase of ~9 weeks (Visit 12-Visit 13) to assess the effect of the investigational treatment on the size of the latent HIV-1 reservoir.~A monitored antiretroviral pause of up to 16 weeks (Visit 14-Visit 33)."
79250|NCT02092116|O1|Outcome|Part B|"Pre-treatment phase of 2-4 weeks (Visit 1-Visit 2) followed by a therapeutic HIV-1 immunization phase of 12 weeks (Visit 2 to Visit 7) in which 1.2 mg Vacc-4x was administered together with 0.06 mg rhuGM-CSF at Visits 2, 3, 4, 5, 6 and 7 follow by a follow-up period of 2 weeks (Visit 8).~A viral reactivation phase of 3 weeks (Visit 9-Visit 11) consisting of one cycle of 3 romidepsin infusions (5 mg/m2) followed by a post-treatment observation phase of ~9 weeks (Visit 12-Visit 13) to assess the effect of the investigational treatment on the size of the latent HIV-1 reservoir.~A monitored antiretroviral pause of up to 16 weeks (Visit 14-Visit 33)."
79306|NCT02091986|E2|Reported Event|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/4.5 ug x 2 BID
79307|NCT02091986|E1|Reported Event|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
80481|NCT02081690|O1|Outcome|Macitentan|Macitentan tablet, dose of 10 mg, once daily
79251|NCT02092116|O1|Outcome|Part A|"Pre-treatment phase of 2-4 weeks (Visit 1- Visit 2a) followed by viral reactivation phase of 3 weeks (Visit 2 to Visit 7) consisting of one cycle of romidepsin infusions at a dosing of 5 mg/m2 on days 0, 7, and 14.~Post-activation phase of ~9 weeks (Visit 8 to Visit 11) to assess the effect of romidepsin on the size of latent HIV-1 reservoir."
79252|NCT02092116|O1|Outcome|Part B|"Pre-treatment phase of 2-4 weeks (Visit 1-Visit 2) followed by a therapeutic HIV-1 immunization phase of 12 weeks (Visit 2 to Visit 7) in which 1.2 mg Vacc-4x was administered together with 0.06 mg rhuGM-CSF at Visits 2, 3, 4, 5, 6 and 7 follow by a follow-up period of 2 weeks (Visit 8).~A viral reactivation phase of 3 weeks (Visit 9-Visit 11) consisting of one cycle of 3 romidepsin infusions (5 mg/m2) followed by a post-treatment observation phase of ~9 weeks (Visit 12-Visit 13) to assess the effect of the investigational treatment on the size of the latent HIV-1 reservoir.~A monitored antiretroviral pause of up to 16 weeks (Visit 14-Visit 33)."
79253|NCT02092116|O1|Outcome|Part A|"Pre-treatment phase of 2-4 weeks (Visit 1- Visit 2a) followed by viral reactivation phase of 3 weeks (Visit 2 to Visit 7) consisting of one cycle of romidepsin infusions at a dosing of 5 mg/m2 on days 0, 7, and 14.~Post-activation phase of ~9 weeks (Visit 8 to Visit 11) to assess the effect of romidepsin on the size of latent HIV-1 reservoir."
79254|NCT02092116|E2|Reported Event|Part B|"Pre-treatment phase of 2-4 weeks (Visit 1-Visit 2) followed by a therapeutic HIV-1 immunization phase of 12 weeks (Visit 2 to Visit 7) in which 1.2 mg Vacc-4x was administered together with 0.06 mg rhuGM-CSF at Visits 2, 3, 4, 5, 6 and 7 follow by a follow-up period of 2 weeks (Visit 8).~A viral reactivation phase of 3 weeks (Visit 9-Visit 11) consisting of one cycle of romidepsin infusion (5 mg/m2) followed by a post-treatment observation phase of ~9 weeks (Visit 12-Visit 13) to assess the effect of the investigational treatment on the size of the latent HIV-1 reservoir.~A monitored antiretroviral pause of up to 16 weeks (Visit 14-Visit 33)."
79255|NCT02092116|E1|Reported Event|Part A|"Pre-treatment phase of 2-4 weeks (Visit 1- Visit 2a) followed by viral reactivation phase of 3 weeks (Visit 2 to Visit 7) consisting of one cycle of romidepsin infusions at a dosing of 5 mg/m2 on days 0, 7, and 14.~Post-activation phase of ~9 weeks (Visit 8 to Visit 11) to assess the effect of romidepsin on the size of latent HIV-1 reservoir."
79256|NCT02091986|B4|Baseline|Total|Total of all reporting groups
79257|NCT02091986|B3|Baseline|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
79258|NCT02091986|B2|Baseline|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/4.5 ug x 2 BID
79259|NCT02091986|B1|Baseline|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
79260|NCT02091986|P3|Participant Flow|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
79261|NCT02091986|P2|Participant Flow|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/4.5 ug x 2 BID
79262|NCT02091986|P1|Participant Flow|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
79263|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
79264|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
79265|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
79266|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
79267|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
79268|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
79269|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
79270|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
79271|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
79272|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
79273|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
79274|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
79275|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
79276|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
79277|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
79278|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
79279|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
79280|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
79281|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
79282|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
79283|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
79284|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
79285|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
79286|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
79287|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
79288|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
79289|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
79290|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
79291|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
79292|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
79293|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
79294|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
79295|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
79296|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
79297|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
79298|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
79299|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
79300|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
79301|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
79302|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
79303|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
79308|NCT02091960|B1|Baseline|Enzalutamide + Trastuzumab|Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
79309|NCT02091960|P1|Participant Flow|Enzalutamide + Trastuzumab|Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
79310|NCT02091960|O1|Outcome|Enzalutamide + Trastuzumab|Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
79311|NCT02091960|O1|Outcome|Enzalutamide + Trastuzumab|Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
79312|NCT02091960|O1|Outcome|Enzalutamide + Trastuzumab|Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
79313|NCT02091960|O1|Outcome|Enzalutamide + Trastuzumab|Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
79314|NCT02091960|O1|Outcome|Enzalutamide + Trastuzumab|Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
79315|NCT02091960|O1|Outcome|Enzalutamide + Trastuzumab|Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
79316|NCT02091960|O1|Outcome|Enzalutamide + Trastuzumab|Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
79317|NCT02091960|O1|Outcome|Enzalutamide + Trastuzumab|Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
79318|NCT02091960|E1|Reported Event|Enzalutamide + Trastuzumab|Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
79319|NCT02091869|B3|Baseline|Total|Total of all reporting groups
79320|NCT02091869|B2|Baseline|Mobile Phone|"Participants will record asthma symptoms, medication usage, and peak flow data on their phones.~Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app."
79321|NCT02091869|B1|Baseline|Paper Asthma Action Plan|"Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.~Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage."
79322|NCT02091869|P2|Participant Flow|Mobile Phone|"Participants will record asthma symptoms, medication usage, and peak flow data on their phones.~Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app."
79323|NCT02091869|P1|Participant Flow|Paper Asthma Action Plan|"Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.~Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage."
79324|NCT02091869|O2|Outcome|Mobile Phone|"Participants will record asthma symptoms, medication usage, and peak flow data on their phones.~Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app."
79325|NCT02091869|O1|Outcome|Paper Asthma Action Plan|"Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.~Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage."
79326|NCT02091869|O2|Outcome|Mobile Phone|"Participants will record asthma symptoms, medication usage, and peak flow data on their phones.~Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app."
79327|NCT02091869|O1|Outcome|Paper Asthma Action Plan|"Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.~Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage."
79328|NCT02091869|O2|Outcome|Mobile Phone|"Participants will record asthma symptoms, medication usage, and peak flow data on their phones.~Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app."
79329|NCT02091869|O1|Outcome|Paper Asthma Action Plan|"Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.~Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage."
79330|NCT02091869|O2|Outcome|Mobile Phone|"Participants will record asthma symptoms, medication usage, and peak flow data on their phones.~Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app."
79537|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
79331|NCT02091869|O1|Outcome|Paper Asthma Action Plan|"Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.~Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage."
79332|NCT02091869|E2|Reported Event|Mobile Phone|"Participants will record asthma symptoms, medication usage, and peak flow data on their phones.~Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app."
79333|NCT02091869|E1|Reported Event|Paper Asthma Action Plan|"Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.~Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage."
79334|NCT02091856|B4|Baseline|Total|Total of all reporting groups
79335|NCT02091856|B3|Baseline|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
79336|NCT02091856|B2|Baseline|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Positive CBT intervention includes set of exercises devised from the positive psychology paradigm. Similarly, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
79337|NCT02091856|B1|Baseline|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Positive CBT intervention includes set of exercises devised from the positive psychology paradigm. Similarly, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
79338|NCT02091856|P3|Participant Flow|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
79339|NCT02091856|P2|Participant Flow|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
79340|NCT02091856|P1|Participant Flow|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
79341|NCT02091856|O3|Outcome|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
79342|NCT02091856|O2|Outcome|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
79343|NCT02091856|O1|Outcome|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
79344|NCT02091856|O3|Outcome|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
79345|NCT02091856|O2|Outcome|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
79346|NCT02091856|O1|Outcome|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
79347|NCT02091856|O3|Outcome|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
79538|NCT02090088|E2|Reported Event|Infants|Infants who were born to enrolled participants during the study.
79348|NCT02091856|O2|Outcome|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
79349|NCT02091856|O1|Outcome|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
79350|NCT02091856|O3|Outcome|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
79351|NCT02091856|O2|Outcome|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
79352|NCT02091856|O1|Outcome|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
79353|NCT02091856|O3|Outcome|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
79354|NCT02091856|O2|Outcome|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
79355|NCT02091856|O1|Outcome|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
79356|NCT02091856|E3|Reported Event|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
79357|NCT02091856|E2|Reported Event|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
79358|NCT02091856|E1|Reported Event|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
79359|NCT02091778|B1|Baseline|Fast Gelling Dressing|Fast gelling dressing
79360|NCT02091778|P1|Participant Flow|Fast Gelling Dressing|Fast gelling dressing
79361|NCT02091778|O1|Outcome|Fast Gelling Dressing|Fast gelling dressing
79362|NCT02091778|E1|Reported Event|Fast Gelling Dressing|Fast gelling dressing
79363|NCT02091752|B1|Baseline|Ruxolitinib|All participants received ruxolitinib.
79364|NCT02091752|P1|Participant Flow|Ruxolitinib|All participants received ruxolitinib.
79365|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
79366|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
79367|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
79368|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
79369|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
79370|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
79371|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
79372|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
79373|NCT02091752|E1|Reported Event|Ruxolitinib|All participants received ruxolitinib.
79374|NCT02091739|B4|Baseline|Total|Total of all reporting groups
79539|NCT02090088|E1|Reported Event|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
79375|NCT02091739|B3|Baseline|MP: IncobotulinumtoxinA (Xeomin) (100 Units)|Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
79376|NCT02091739|B2|Baseline|MP: IncobotulinumtoxinA (Xeomin) (75 Units)|Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
79377|NCT02091739|B1|Baseline|MP: Placebo|Participants received one injection session of overall 2.0 mL placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
79378|NCT02091739|P5|Participant Flow|EP: IncobotulinumtoxinA (Xeomin) (100 Units)|Participants received overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands at each of the three injection sessions in the EP.
79379|NCT02091739|P4|Participant Flow|EP: IncobotulinumtoxinA (Xeomin) (75 Units)|Participants received overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands at each of the three injection sessions in the EP.
79380|NCT02091739|P3|Participant Flow|MP: IncobotulinumtoxinA (Xeomin) (100 Units)|Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
79381|NCT02091739|P2|Participant Flow|MP: IncobotulinumtoxinA (Xeomin) (75 Units)|Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
79382|NCT02091739|P1|Participant Flow|Placebo|Participants received one injection session of overall 2.0 milliliter (mL) placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
79383|NCT02091739|O3|Outcome|MP: IncobotulinumtoxinA (Xeomin) (100 Units)|Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
79384|NCT02091739|O2|Outcome|MP: IncobotulinumtoxinA (Xeomin) (75 Units)|Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
79385|NCT02091739|O1|Outcome|MP: Placebo|Participants received one injection session of overall 2.0 mL placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
79386|NCT02091739|O3|Outcome|MP: IncobotulinumtoxinA (Xeomin) (100 Units)|Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
79387|NCT02091739|O2|Outcome|MP: IncobotulinumtoxinA (Xeomin) (75 Units)|Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
79388|NCT02091739|O1|Outcome|MP: Placebo|Participants received one injection session of overall 2.0 mL placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
79389|NCT02091739|O3|Outcome|MP: IncobotulinumtoxinA (Xeomin) (100 Units)|Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
79390|NCT02091739|O2|Outcome|MP: IncobotulinumtoxinA (Xeomin) (75 Units)|Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
79391|NCT02091739|O1|Outcome|MP: Placebo|Participants received one injection session of overall 2.0 mL placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
79392|NCT02091739|O3|Outcome|MP: IncobotulinumtoxinA (Xeomin) (100 Units)|Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
79393|NCT02091739|O2|Outcome|MP: IncobotulinumtoxinA (Xeomin) (75 Units)|Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
79394|NCT02091739|O1|Outcome|MP: Placebo|Participants received one injection session of overall 2.0 mL placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
79395|NCT02091739|E5|Reported Event|EP: IncobotulinumtoxinA (Xeomin) (100 Units)|Participants received overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands at each of the three injection sessions in the EP.
79396|NCT02091739|E4|Reported Event|EP: IncobotulinumtoxinA (Xeomin) (75 Units)|Participants received overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands at each of the three injection sessions in the EP.
79397|NCT02091739|E3|Reported Event|MP: IncobotulinumtoxinA (Xeomin) (100 Units)|Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
79398|NCT02091739|E2|Reported Event|MP: IncobotulinumtoxinA (Xeomin) (75 Units)|Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
79399|NCT02091739|E1|Reported Event|Placebo|Participants received one injection session of overall 2.0 mL placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
79400|NCT02091726|B1|Baseline|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
79401|NCT02091726|P1|Participant Flow|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
79402|NCT02091726|O1|Outcome|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
79403|NCT02091726|O1|Outcome|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
79404|NCT02091726|O1|Outcome|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
79405|NCT02091726|O1|Outcome|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
79406|NCT02091726|O1|Outcome|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
79407|NCT02091726|E1|Reported Event|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
79408|NCT02091466|B3|Baseline|Total|Total of all reporting groups
79409|NCT02091466|B2|Baseline|Control|Eligible participants were pregnant women between 18 and 40 years of age, with singleton pregnancy and gestation longer than 37 weeks, scheduled for elective cesarean section
79410|NCT02091466|B1|Baseline|Pre-warming|Eligible participants were pregnant women between 18 and 40 years of age, with singleton pregnancy and gestation longer than 37 weeks, scheduled for elective cesarean section
79411|NCT02091466|P2|Participant Flow|Control|patients were under passive heating in control groups before anesthesia
79412|NCT02091466|P1|Participant Flow|Pre-warming|"patients were under heating system in experimental groups~heating system pre-warming: warming 30 minutes prior to anesthesia"
79413|NCT02091466|O2|Outcome|Control|Patients remained without the use of a thermal gown,
79414|NCT02091466|O1|Outcome|Pre-warming|Patients were covered with a thermal gown (Bair Paws Standard Warming Gown 810 model with a Bair Hugger, model 850 warming unit) with forced-air flow at 40ºC in the preoperative care unit 30 minutes before the spinal anesthesia.
79415|NCT02091466|E2|Reported Event|Control|Patients were under passive heating in control groups before anesthesia
79416|NCT02091466|E1|Reported Event|Pre-warming|"Patients were under heating system in experimental groups~heating system pre-warming: warming 30 minutes prior to anesthesia"
79417|NCT02091414|B1|Baseline|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
79418|NCT02091414|P1|Participant Flow|Mycophenolate Mofetil (MMF) Plus (+) Cyclosporine A (CsA)|Participants received MMF 1.0 grams (g), capsules orally (PO), twice daily (BID) from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 milligrams per kilogram (mg/kg) PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 nanograms per milliliter (ng/mL) through Week 24. Participants also received corticosteroids as per the practice of each participating center.
79419|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
79420|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
79421|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
79422|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
79423|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
79669|NCT02087670|B2|Baseline|Community Based Exercise|educational program and not supervises exercise program
79424|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
79425|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
79426|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
79427|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
79428|NCT02091414|E1|Reported Event|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
79429|NCT02090855|B1|Baseline|Flutemetamol (18F)|There are no interventions in this study. This study is to assess the images taken previously from another study, GE-067-007. No drug was administered.
79430|NCT02090855|P1|Participant Flow|Flutemetamol (18F)|There are no interventions in this study. This study is to assess the images taken previously from another study, GE-067-007. No drug was administered. Subjects were previously dosed in Study GE-067-007.
79431|NCT02090855|O1|Outcome|Percentage of Specificity for Normal Reads|This is the percentage of Specificity with the normal image interpretations.
79432|NCT02090855|O1|Outcome|Percentage of Sensitivity With Abnormal Reads|This is the percent of sensitivity with the Abnormal image interpretations.
79433|NCT02090855|O1|Outcome|Standard of Truth (SoT)|Each Reader will have a total of 30 image interpretations when combining normal and abnormal readings.The Standard of Truth (SoT) is based on no/sparse neuritic (amyloid) plaques, per modified Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) criteria based on specimens stained with the Bielschowsky silver stain.
79434|NCT02090855|O1|Outcome|Standard of Truth (SoT)|Each Reader will have a total of 76 image interpretations when combining normal and abnormal readings.The Standard of Truth is based on moderate/frequent neuritic (amyloid) plaques, per modified Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) criteria, based on specimens stained with the Bielschowsky silver stain.
79435|NCT02090855|E1|Reported Event|Flutemetamol (18F)|This study was to assess the PET images only. There was no drug administered in this study.
79436|NCT02090777|B1|Baseline|Health Coach|"Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.~Health Coach"
79437|NCT02090777|P1|Participant Flow|Health Coach|"Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.~Health Coach"
79438|NCT02090777|O1|Outcome|Health Coach|"Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.~Health Coach"
79439|NCT02090777|E1|Reported Event|Health Coach|"Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.~Health Coach"
79440|NCT02090764|B3|Baseline|Total|Total of all reporting groups
79441|NCT02090764|B2|Baseline|Placebo|"Placebo cream~Placebo"
79442|NCT02090764|B1|Baseline|Ozenoxacin|"ozenoxacin cream 1%~Ozenoxacin"
79443|NCT02090764|P2|Participant Flow|Placebo|"Placebo cream~Placebo"
79444|NCT02090764|P1|Participant Flow|Ozenoxacin|"ozenoxacin cream 1%~Ozenoxacin"
79445|NCT02090764|O2|Outcome|Placebo|"Placebo cream~Placebo"
79446|NCT02090764|O1|Outcome|Ozenoxacin|"ozenoxacin cream 1%~Ozenoxacin"
79447|NCT02090764|E2|Reported Event|Placebo|"Placebo cream~Placebo"
79448|NCT02090764|E1|Reported Event|Ozenoxacin|"ozenoxacin cream 1%~Ozenoxacin"
79449|NCT02090413|B4|Baseline|Total|Total of all reporting groups
79450|NCT02090413|B3|Baseline|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79451|NCT02090413|B2|Baseline|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79452|NCT02090413|B1|Baseline|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79453|NCT02090413|P3|Participant Flow|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79454|NCT02090413|P2|Participant Flow|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79455|NCT02090413|P1|Participant Flow|DMF + ASA-Placebo BID|Dimethyl fumarate (DMF) 120 mg taken twice daily (BID) for the first 7 days and 240 mg BID from Week 2 through Week 48. Acetylsalicylic acid (ASA)-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79456|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79457|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79458|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79459|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79460|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79461|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79462|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79463|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79464|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79465|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79466|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79467|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79468|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79469|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79470|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79471|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79472|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79473|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79474|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79475|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79476|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79477|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79478|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79479|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79480|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79481|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79482|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79483|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79484|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79485|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79486|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79487|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79488|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79489|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79490|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79491|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79492|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79493|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79494|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79495|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79496|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79497|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79498|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79499|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79500|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79501|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79502|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79503|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79504|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79505|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79506|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79540|NCT02089737|B1|Baseline|Panitumumab|Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
79507|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79508|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79509|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79510|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79511|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79512|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79513|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79514|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79515|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79516|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79517|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79518|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79519|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79520|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79521|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79522|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79523|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79524|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79525|NCT02090413|E3|Reported Event|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79526|NCT02090413|E2|Reported Event|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79527|NCT02090413|E1|Reported Event|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
79528|NCT02090088|B1|Baseline|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
79529|NCT02090088|P1|Participant Flow|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
79530|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
79531|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
79532|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
79533|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
79534|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
79535|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
79536|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
79541|NCT02089737|P1|Participant Flow|Panitumumab|Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
79542|NCT02089737|O1|Outcome|Panitumumab|Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
79543|NCT02089737|O1|Outcome|Panitumumab|Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
79544|NCT02089737|O1|Outcome|Panitumumab|Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
79545|NCT02089737|E2|Reported Event|Concomitant Administration of Panitumumab and Chemotherapy|
79546|NCT02089737|E1|Reported Event|Panitumumab|Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
79547|NCT02089347|B3|Baseline|Total|Total of all reporting groups
79548|NCT02089347|B2|Baseline|DT Group|Participants received DT vaccine subcutaneously
79549|NCT02089347|B1|Baseline|SP306 Group|Participants received SP306 vaccine intramuscularly
79550|NCT02089347|P2|Participant Flow|DT Group|Participants received DT vaccine subcutaneously
79551|NCT02089347|P1|Participant Flow|SP306 Group|Participants received SP306 vaccine intramuscularly
79552|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
79553|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
79554|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
79555|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
79556|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
79557|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
79558|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
79559|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
79560|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
79561|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
79562|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
79563|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
79564|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
79565|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
79566|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
79567|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
79568|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
79569|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
79570|NCT02089347|E2|Reported Event|DT Group|Participants received DT vaccine subcutaneously
79571|NCT02089347|E1|Reported Event|SP306 Group|Participants received SP306 vaccine intramuscularly
79572|NCT02089191|B1|Baseline|Overall|Nelfilcon A and stenfilcon A contact lenses worn for 12 hours each in Period 1 and 2 as randomized
79573|NCT02089191|P2|Participant Flow|MyDay/DACP|Stenfilcon A contact lenses worn in Period 1, followed by nelfilcon A contact lenses in Period 2
79574|NCT02089191|P1|Participant Flow|DACP/MyDay|Nelfilcon A contact lenses worn in Period 1, followed by stenfilcon A contact lenses in Period 2
79575|NCT02089191|O2|Outcome|MyDay|Stenfilcon A contact lenses
79576|NCT02089191|O1|Outcome|DACP|Nelfilcon A contact lenses
79577|NCT02089191|O2|Outcome|MyDay|Stenfilcon A contact lenses
79578|NCT02089191|O1|Outcome|DACP|Nelfilcon A contact lenses
79579|NCT02089191|E2|Reported Event|MyDay|Stenfilcon A contact lenses
79580|NCT02089191|E1|Reported Event|DACP|Nelfilcon A contact lenses
79581|NCT02089113|B3|Baseline|Total|Total of all reporting groups
79582|NCT02089113|B2|Baseline|PVPP (Placebo Punctum Plug)|"Resorbable hydrogel drug delivery vehicle containing no drug~Punctum Plug"
79583|NCT02089113|B1|Baseline|OTX-DP (Dexamethasone Punctum Plug)|"Resorbable hydrogel drug delivery vehicle containing dexamethasone~Dexamethasone"
79584|NCT02089113|P2|Participant Flow|Placebo Vehicle Punctum Plug|No drug treatment
79585|NCT02089113|P1|Participant Flow|Dexamethasone Punctum Plug|Drug treatment
79586|NCT02089113|O2|Outcome|Placebo Vehicle Punctum Plug|No drug treatment
79587|NCT02089113|O1|Outcome|Dexamethasone Punctum Plug|Drug treatment
79588|NCT02089113|E2|Reported Event|Placebo Vehicle Punctum Plug|No drug treatment
79589|NCT02089113|E1|Reported Event|Dexamethasone Punctum Plug|Drug treatment
79590|NCT02088957|B1|Baseline|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
79591|NCT02088957|P2|Participant Flow|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
79628|NCT02087943|O2|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
79629|NCT02087943|O1|Outcome|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
79592|NCT02088957|P1|Participant Flow|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
79593|NCT02088957|O2|Outcome|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
79594|NCT02088957|O1|Outcome|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
79595|NCT02088957|O2|Outcome|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
79596|NCT02088957|O1|Outcome|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
79597|NCT02088957|O2|Outcome|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
79598|NCT02088957|O1|Outcome|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
79599|NCT02088957|O2|Outcome|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
79600|NCT02088957|O1|Outcome|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
79601|NCT02088957|O2|Outcome|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
79626|NCT02087943|O1|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued receiving 30 mg apremilast tablets twice daily (BID) up to Week 24 in the active treatment, and for participants who were initially randomized to placebo and at week 12 subsequently randomized to 30 mg apremilast tablets twice daily in the active treatment phase.
79668|NCT02087670|B3|Baseline|Total|Total of all reporting groups
79602|NCT02088957|O1|Outcome|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
79603|NCT02088957|O2|Outcome|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
79604|NCT02088957|O1|Outcome|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
79605|NCT02088957|E2|Reported Event|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
79606|NCT02088957|E1|Reported Event|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
79607|NCT02088177|B1|Baseline|Open Label Group|open label group receiving injections of long acting naltrexone
79608|NCT02088177|P1|Participant Flow|Open Label Group|open label group receiving injections of long acting naltrexone
79609|NCT02088177|O1|Outcome|Open Label Group|open label group receiving injections of long acting naltrexone
79610|NCT02088177|O1|Outcome|Open Label Group|open label group receiving injections of long acting naltrexone
79611|NCT02088177|E1|Reported Event|Open Label Group|open label group receiving injections of long acting naltrexone
79612|NCT02087995|B1|Baseline|Real Time Continuous Glucose Monitoring System|Real Time Continuous Glucose Monitoring System Wear over a 7 day period
79613|NCT02087995|P1|Participant Flow|Real Time Continuous Glucose Monitoring System|Real Time Continuous Glucose Monitoring System Wear over a 7 day period
79614|NCT02087995|O1|Outcome|Real Time Continuous Glucose Monitoring System|Real Time Continuous Glucose Monitoring System Wear over a 7 day period
79615|NCT02087995|E1|Reported Event|Real Time Continuous Glucose Monitoring System|Real Time Continuous Glucose Monitoring System Wear over a 7 day period
79616|NCT02087943|B4|Baseline|Total|Total of all reporting groups
79617|NCT02087943|B3|Baseline|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
79618|NCT02087943|B2|Baseline|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
79619|NCT02087943|B1|Baseline|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
79620|NCT02087943|P5|Participant Flow|Placebo/Apremilast 40 mg|Participants initially randomized to identically matching placebo tablets twice daily and were re-randomized at Week 12 to 40 mg apremilast for 12 weeks, up to week 24.
79621|NCT02087943|P4|Participant Flow|Placebo/Apremilast 30 mg|Participants initially randomized to identically matching placebo tablets twice daily and were re-randomized at Week 12 to 30 mg apremilast for 12 weeks, up to week 24.
79622|NCT02087943|P3|Participant Flow|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued to receive 40 mg apremilast tablets twice daily (BID) for up to Week 24 in the active treatment phase.
79623|NCT02087943|P2|Participant Flow|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued to receive 30 mg apremilast tablets twice daily (BID) for up to Week 24 in the active treatment phase
79624|NCT02087943|P1|Participant Flow|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
79625|NCT02087943|O2|Outcome|Apremilast 40 mg|Participants initially randomized to 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued receiving 40 mg apremilast tablets twice daily (BID) up to Week 24 in the active treatment phase, and for participants who were initially randomized to placebo and at week 12 subsequently randomized to 40 mg apremilast tablets twice daily in the active treatment phase.
79627|NCT02087943|O3|Outcome|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
79630|NCT02087943|O3|Outcome|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
79631|NCT02087943|O2|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
79632|NCT02087943|O1|Outcome|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
79633|NCT02087943|O3|Outcome|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
79634|NCT02087943|O2|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
79635|NCT02087943|O1|Outcome|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
79636|NCT02087943|O3|Outcome|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
79637|NCT02087943|O2|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
79638|NCT02087943|O1|Outcome|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
79639|NCT02087943|O3|Outcome|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
79640|NCT02087943|O2|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
79641|NCT02087943|O1|Outcome|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
79642|NCT02087943|E5|Reported Event|Apremilast 40 mg (Apremilast Exposure Period) 0-24|Participants who received 40 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 12 up until Week 24.
79643|NCT02087943|E4|Reported Event|Apremilast 30 mg (Apremilast Exposure Period) 0-24|Participants who received 30 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 12 up until Week 24.
79644|NCT02087943|E3|Reported Event|Apremilast 40 mg (Weeks 0-12)|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
79645|NCT02087943|E2|Reported Event|Apremilast 30 mg (Weeks 0-12)|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
79646|NCT02087943|E1|Reported Event|Placebo (Weeks 0-12)|Participants initially randomized to identically matching PBO tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
79647|NCT02087774|B3|Baseline|Total|Total of all reporting groups
79648|NCT02087774|B2|Baseline|Intervention Group|"Oneparticipated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.~The responsibility was given to the principal to implement the program.~Physical Activity and Incentives"
79649|NCT02087774|B1|Baseline|Control School|Control School received no intervention.
79650|NCT02087774|P2|Participant Flow|Intervention Group|"Two schools participated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.~One intervention school implemented the program with responsibility given to the principal (school-wide group) and the other school asked the individual teachers to implement the program daily (classroom based group).~Physical Activity and Incentives"
79651|NCT02087774|P1|Participant Flow|Control School|Control School received no intervention.
79652|NCT02087774|O2|Outcome|Intervention Group|"Oneparticipated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.~The responsibility was given to the principal to implement the program.~Physical Activity and Incentives"
79653|NCT02087774|O1|Outcome|Control School|Control School received no intervention.
79654|NCT02087774|O2|Outcome|Intervention Group|"Oneparticipated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.~The responsibility was given to the principal to implement the program.~Physical Activity and Incentives"
79655|NCT02087774|O1|Outcome|Control School|Control School received no intervention.
79656|NCT02087774|E2|Reported Event|Intervention Group|"Oneparticipated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.~The responsibility was given to the principal to implement the program.~Physical Activity and Incentives"
79657|NCT02087774|E1|Reported Event|Control School|Control School received no intervention.
79658|NCT02087748|B1|Baseline|1% Diclofenac Sodium Gel|Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours to one leg, and placebo to the other leg.
79659|NCT02087748|P1|Participant Flow|1% Diclofenac Sodium Gel|Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours to one leg, and placebo to the other leg.
79660|NCT02087748|O2|Outcome|Placebo|"Placebo gel 4gm applied topically Q6 hour for 48 hours~Placebo: Placebo gel 4gm applied topically Q6 hour for 48 hours"
79661|NCT02087748|O1|Outcome|1% Diclofenac Sodium Gel|"Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours~1% diclofenac sodium gel: Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours"
79662|NCT02087748|O2|Outcome|Placebo|"Placebo gel 4gm applied topically Q6 hour for 48 hours~Placebo: Placebo gel 4gm applied topically Q6 hour for 48 hours"
79663|NCT02087748|O1|Outcome|1% Diclofenac Sodium Gel|"Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours~1% diclofenac sodium gel: Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours"
79664|NCT02087748|O2|Outcome|Placebo|"Placebo gel 4gm applied topically Q6H for 48 hours~Placebo: gel manufactured to mimic Diclofenac sodium1% gel"
79665|NCT02087748|O1|Outcome|1% Diclofenac Sodium Gel|"Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours~1% diclofenac sodium gel"
79666|NCT02087748|E2|Reported Event|Placebo|"Placebo gel 4gm applied topically Q6H for 48 hours~Placebo: gel manufactured to mimic Diclofenac sodium1% gel"
79667|NCT02087748|E1|Reported Event|1% Diclofenac Sodium Gel|"Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours~1% diclofenac sodium gel"
79670|NCT02087670|B1|Baseline|Controlled, Supervised Exercise Protocol|"controlled, supervised exercise protocol within a cardiac rehabilitation program~controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program"
79671|NCT02087670|P2|Participant Flow|Community Based Exercise|educational program and not supervises exercise program
79672|NCT02087670|P1|Participant Flow|Controlled, Supervised Exercise Protocol|"controlled, supervised exercise protocol within a cardiac rehabilitation program~controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program"
79673|NCT02087670|O2|Outcome|Community Based Exercise|educational program and not supervises exercise program
79674|NCT02087670|O1|Outcome|Controlled, Supervised Exercise Protocol|"controlled, supervised exercise protocol within a cardiac rehabilitation program~controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program"
79675|NCT02087670|O2|Outcome|Community Based Exercise|educational program and not supervises exercise program
79676|NCT02087670|O1|Outcome|Controlled, Supervised Exercise Protocol|"controlled, supervised exercise protocol within a cardiac rehabilitation program~controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program"
79677|NCT02087670|E2|Reported Event|Community Based Exercise|educational program and not supervises exercise program
79678|NCT02087670|E1|Reported Event|Controlled, Supervised Exercise Protocol|controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program
79679|NCT02087514|B7|Baseline|Total|Total of all reporting groups
79680|NCT02087514|B6|Baseline|Transfusion of PRBC Stored for 6 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 6 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
79681|NCT02087514|B5|Baseline|Transfusion of PRBC Stored for 5 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 5 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
79682|NCT02087514|B4|Baseline|Transfusion of PRBC Stored for 4 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 4 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
79683|NCT02087514|B3|Baseline|Transfusion of PRBC Stored for 3 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 3 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
79684|NCT02087514|B2|Baseline|Transfusion of PRBC Stored for 2 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 2 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
79685|NCT02087514|B1|Baseline|Transfusion of PRBC Stored for 1 Week|"Subjects will receive blood transfusion with packed red blood cells stored for 1 week.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
79686|NCT02087514|P6|Participant Flow|Transfusion of PRBC Stored for 6 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 6 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
79687|NCT02087514|P5|Participant Flow|Transfusion of PRBC Stored for 5 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 5 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
79751|NCT02087241|O3|Outcome|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
79752|NCT02087241|O2|Outcome|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
79688|NCT02087514|P4|Participant Flow|Transfusion of PRBC Stored for 4 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 4 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
79689|NCT02087514|P3|Participant Flow|Transfusion of PRBC Stored for 3 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 3 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
79690|NCT02087514|P2|Participant Flow|Transfusion of PRBC Stored for 2 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 2 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
79691|NCT02087514|P1|Participant Flow|Transfusion of PRBC Stored for 1 Week|"Subjects will receive blood transfusion with packed red blood cells stored for 1 week.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
79692|NCT02087514|O6|Outcome|Transfusion of PRBC Stored for 6 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 6 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
79693|NCT02087514|O5|Outcome|Transfusion of PRBC Stored for 5 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 5 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
79694|NCT02087514|O4|Outcome|Transfusion of PRBC Stored for 4 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 4 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
79695|NCT02087514|O3|Outcome|Transfusion of PRBC Stored for 3 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 3 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
79696|NCT02087514|O2|Outcome|Transfusion of PRBC Stored for 2 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 2 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
79697|NCT02087514|O1|Outcome|Transfusion of PRBC Stored for 1 Week|"Subjects will receive blood transfusion with packed red blood cells stored for 1 week.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
79698|NCT02087514|E6|Reported Event|Transfusion of PRBC Stored for 6 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 6 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
79753|NCT02087241|O1|Outcome|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
79699|NCT02087514|E5|Reported Event|Transfusion of PRBC Stored for 5 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 5 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
79700|NCT02087514|E4|Reported Event|Transfusion of PRBC Stored for 4 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 4 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
79701|NCT02087514|E3|Reported Event|Transfusion of PRBC Stored for 3 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 3 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
79702|NCT02087514|E2|Reported Event|Transfusion of PRBC Stored for 2 Weeks|"Subjects will receive blood transfusion with packed red blood cells stored for 2 weeks.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
79703|NCT02087514|E1|Reported Event|Transfusion of PRBC Stored for 1 Week|"Subjects will receive blood transfusion with packed red blood cells stored for 1 week.~Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.~Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.~The number of weeks in storage are as follows:~1 week~2 weeks~3 weeks~4 weeks~5 weeks~6 weeks"
79704|NCT02087423|B4|Baseline|Total|Total of all reporting groups
79705|NCT02087423|B3|Baseline|Cohort 3 (TC >= 90%)|consisted of patients who were EGFR/ALK wild type/unknown and prospectively determined to be PD-L1 high (TC >=90%)
79706|NCT02087423|B2|Baseline|Cohort 2|consisted of patients who were EGFR/ALK wild type/unknown and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.
79707|NCT02087423|B1|Baseline|Cohort 1 (EGFR/ALK+)|consisted of patients who were EGFR/ALK positive and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.
79708|NCT02087423|P3|Participant Flow|Cohort 3 (TC >= 90%)|consisted of patients who were EGFR/ALK wild type/unknown and prospectively determined to be PD-L1 high (TC >=90%).
79709|NCT02087423|P2|Participant Flow|Cohort 2|consisted of patients who were EGFR/ALK wild type/unknown and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.
79710|NCT02087423|P1|Participant Flow|Cohort 1 (EGFR/ALK+)|consisted of patients who were EGFR/ALK positive and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.
79711|NCT02087423|O5|Outcome|Cohort 3 (TC>=90%)|consisted of patients who were EGFR/ALK wild type/unknown and prospectively determined to be PD-L1 high (TC>=90%).
79712|NCT02087423|O4|Outcome|Cohort 2 PD-L1+ (<25%)|consisted of patients who were EGFR/ALK wild type/unknown and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.
79713|NCT02087423|O3|Outcome|Cohort 2 PD-L1+ (>=25%)|consisted of patients who were EGFR/ALK wild type/unknown and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown. Patients with PD-L1 TC>=90% are included within the PD-L1 high (TC>=25%) group.
79714|NCT02087423|O2|Outcome|Cohort 1 (EGFR/ALK+) PD-L1+ (<25%)|consisted of patients who were EGFR/ALK positive and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.
79715|NCT02087423|O1|Outcome|Cohort 1 (EGFR/ALK+) PD-L1+ (>=25%)|consisted of patients who were EGFR/ALK positive and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown. patients with PD-L1 TC>=90% are included in this group.
79716|NCT02087423|O5|Outcome|Cohort 3 (TC>=90%)|consisted of patients who were EGFR/ALK wild type/unknown and prospectively determined to be PD-L1 high (TC>=90%).
79717|NCT02087423|O4|Outcome|Cohort 2 PD-L1+ (<25%)|consisted of patients who were EGFR/ALK wild type/unknown and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.
79718|NCT02087423|O3|Outcome|Cohort 2 PD-L1+ (>=25%)|consisted of patients who were EGFR/ALK wild type/unknown and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown. Patients with PD-L1 TC>=90% are included within the PD-L1 high (TC>=25%) group.
79719|NCT02087423|O2|Outcome|Cohort 1 (EGFR/ALK+) PD-L1+ (<25%)|consisted of patients who were EGFR/ALK positive and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.
79720|NCT02087423|O1|Outcome|Cohort 1 (EGFR/ALK+) PD-L1+ (>=25%)|consisted of patients who were EGFR/ALK positive and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown. patients with PD-L1 TC>=90% are included in this group.
79721|NCT02087423|O5|Outcome|Cohort 3 (TC>=90%)|consisted of patients who were EGFR/ALK wild type/unknown and prospectively determined to be PD-L1 high (TC>=90%).
79722|NCT02087423|O4|Outcome|Cohort 2 PD-L1+ (<25%)|consisted of patients who were EGFR/ALK wild type/unknown and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.
79723|NCT02087423|O3|Outcome|Cohort 2 PD-L1+ (>=25%)|consisted of patients who were EGFR/ALK wild type/unknown and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown. Patients with PD-L1 TC>=90% are included within the PD-L1 high (TC>=25%) group.
79724|NCT02087423|O2|Outcome|Cohort 1 (EGFR/ALK+) PD-L1+ (<25%)|consisted of patients who were EGFR/ALK positive and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.
79725|NCT02087423|O1|Outcome|Cohort 1 (EGFR/ALK+) PD-L1+ (>=25%)|consisted of patients who were EGFR/ALK positive and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown. patients with PD-L1 TC>=90% are included in this group.
79726|NCT02087423|E3|Reported Event|Cohort 3 (TC >= 90%)|consisted of patients who were EGFR/ALK wild type/unknown and prospectively determined to be PD-L1 high (TC >=90%)
79727|NCT02087423|E2|Reported Event|Cohort 2|consisted of patients who were EGFR/ALK wild type/unknown and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.
79728|NCT02087423|E1|Reported Event|Cohort 1 (EGFR/ALK+)|consisted of patients who were EGFR/ALK positive and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.
79729|NCT02087241|B5|Baseline|Total|Total of all reporting groups
79730|NCT02087241|B4|Baseline|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5
79731|NCT02087241|B3|Baseline|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
79732|NCT02087241|B2|Baseline|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
79733|NCT02087241|B1|Baseline|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
79734|NCT02087241|P4|Participant Flow|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5
79735|NCT02087241|P3|Participant Flow|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
79736|NCT02087241|P2|Participant Flow|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
79737|NCT02087241|P1|Participant Flow|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
79738|NCT02087241|O4|Outcome|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21-Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5.
79739|NCT02087241|O3|Outcome|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
79740|NCT02087241|O2|Outcome|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
79741|NCT02087241|O1|Outcome|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
79742|NCT02087241|O4|Outcome|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21-Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5.
79743|NCT02087241|O3|Outcome|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
79744|NCT02087241|O2|Outcome|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
79745|NCT02087241|O1|Outcome|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
79746|NCT02087241|O4|Outcome|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21-Day cycle)/Pemetrexed 400 mg/Carboplatin AUC 5
79747|NCT02087241|O3|Outcome|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
79748|NCT02087241|O2|Outcome|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
79749|NCT02087241|O1|Outcome|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
79750|NCT02087241|O4|Outcome|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5
79754|NCT02087241|O4|Outcome|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5
79755|NCT02087241|O3|Outcome|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
79756|NCT02087241|O2|Outcome|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
79757|NCT02087241|O1|Outcome|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
79758|NCT02087241|E4|Reported Event|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21-Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5.
79759|NCT02087241|E3|Reported Event|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
79760|NCT02087241|E2|Reported Event|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
79761|NCT02087241|E1|Reported Event|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
79762|NCT02087176|B1|Baseline|Part A: AZD1775 Plus Docetaxel|Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
79763|NCT02087176|P1|Participant Flow|Part A: AZD1775 Plus Docetaxel|Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
79764|NCT02087176|O1|Outcome|Part A: AZD1775 Plus Docetaxel|Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
79765|NCT02087176|O1|Outcome|Part A: AZD1775 Plus Docetaxel|Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
79766|NCT02087176|E1|Reported Event|Part A: AZD1775 Plus Docetaxel|Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
79767|NCT02087059|B1|Baseline|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
79768|NCT02087059|P1|Participant Flow|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
79769|NCT02087059|O1|Outcome|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
79770|NCT02087059|O1|Outcome|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
79771|NCT02087059|O1|Outcome|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
79772|NCT02087059|O1|Outcome|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
79773|NCT02087059|O1|Outcome|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
79774|NCT02087059|E1|Reported Event|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
79775|NCT02086786|B3|Baseline|Total|Total of all reporting groups
79776|NCT02086786|B2|Baseline|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals~Risperidone ISM"
79777|NCT02086786|B1|Baseline|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals~Risperidone ISM"
79778|NCT02086786|P2|Participant Flow|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals~Risperidone ISM"
79779|NCT02086786|P1|Participant Flow|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals~Risperidone ISM"
79780|NCT02086786|O2|Outcome|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals~Risperidone ISM"
79781|NCT02086786|O1|Outcome|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals~Risperidone ISM"
79782|NCT02086786|O2|Outcome|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals~Risperidone ISM"
79783|NCT02086786|O1|Outcome|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals~Risperidone ISM"
79784|NCT02086786|O2|Outcome|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals~Risperidone ISM"
79785|NCT02086786|O1|Outcome|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals~Risperidone ISM"
79786|NCT02086786|O2|Outcome|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals~Risperidone ISM"
79787|NCT02086786|O1|Outcome|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals~Risperidone ISM"
79788|NCT02086786|O2|Outcome|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals~Risperidone ISM"
79789|NCT02086786|O1|Outcome|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals~Risperidone ISM"
79790|NCT02086786|O2|Outcome|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals~Risperidone ISM"
79791|NCT02086786|O1|Outcome|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals~Risperidone ISM"
79792|NCT02086786|O2|Outcome|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals~Risperidone ISM"
79793|NCT02086786|O1|Outcome|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals~Risperidone ISM"
79794|NCT02086786|O2|Outcome|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals~Risperidone ISM"
79795|NCT02086786|O1|Outcome|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals~Risperidone ISM"
79796|NCT02086786|O2|Outcome|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals~Risperidone ISM"
79797|NCT02086786|O1|Outcome|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals~Risperidone ISM"
79798|NCT02086786|O2|Outcome|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals~Risperidone ISM: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.~Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals."
79799|NCT02086786|O1|Outcome|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals~Risperidone ISM: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.~Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals."
79800|NCT02086786|E2|Reported Event|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals~Risperidone ISM"
79801|NCT02086786|E1|Reported Event|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals~Risperidone ISM"
79802|NCT02086708|B1|Baseline|Shear Wave Sonoelastography, Fibrosis|"Shear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy.~Shear Wave sonoelastography: Shear Wave Sonoelastography as a ultrasound technique to measure liver fibrosis is performed on patients scheduled for non-focal liver biopsy. Results are compared with pathological score from liver biopsy."
79803|NCT02086708|P1|Participant Flow|Shear Wave Sonoelastography, Fibrosis|"Shear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy.~Shear Wave sonoelastography: Shear Wave Sonoelastography as a ultrasound technique to measure liver fibrosis is performed on patients scheduled for non-focal liver biopsy. Results are compared with pathological score from liver biopsy."
79804|NCT02086708|O5|Outcome|Fibrosis 4|Patients with liver biopsy METAVIR stage 4 on pathology evaluation
79805|NCT02086708|O4|Outcome|Fibrosis 3|Patients with liver biopsy METAVIR stage 3 on pathology evaluation
79806|NCT02086708|O3|Outcome|Fibrosis 2|Patients with liver biopsy METAVIR stage 2 on pathology evaluation
79807|NCT02086708|O2|Outcome|Fibrosis 1|Patients with liver biopsy METAVIR stage 1 on pathology evaluation
79808|NCT02086708|O1|Outcome|Fibrosis 0|Patients with no Fibrosis on liver biopsy evaluation
79809|NCT02086708|E5|Reported Event|Fibrosis 4|Patients with liver biopsy METAVIR stage 4 on pathology evaluation
79810|NCT02086708|E4|Reported Event|Fibrosis 3|Patients with liver biopsy METAVIR stage 3 on pathology evaluation
79811|NCT02086708|E3|Reported Event|Fibrosis 2|Patients with liver biopsy METAVIR stage 2 on pathology evaluation
79812|NCT02086708|E2|Reported Event|Fibrosis 1|Patients with liver biopsy METAVIR stage 1 on pathology evaluation
79813|NCT02086708|E1|Reported Event|Fibrosis 0|Patients with no Fibrosis on liver biopsy evaluation
79814|NCT02086591|B1|Baseline|Doxycycline|"Doxycycline 200 mg twice daily~Doxycycline"
79815|NCT02086591|P1|Participant Flow|Doxycycline|"Doxycycline 200 mg twice daily~Doxycycline"
79816|NCT02086591|O1|Outcome|Doxycycline|"Doxycycline 200 mg twice daily~Doxycycline"
79817|NCT02086591|O1|Outcome|Doxycycline|"Doxycycline 200 mg twice daily~Doxycycline"
79818|NCT02086591|O1|Outcome|Doxycycline|"Doxycycline 200 mg twice daily~Doxycycline"
79819|NCT02086591|E1|Reported Event|Doxycycline|"Doxycycline 200 mg twice daily~Doxycycline"
79820|NCT02085785|B3|Baseline|Total|Total of all reporting groups
79821|NCT02085785|B2|Baseline|Self-directed|"Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group, but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.~Self-directed control group: Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own."
79822|NCT02085785|B1|Baseline|Coached|"Participants randomized to the coached arm will receive the same educational and self-monitoring materials as the self-directed group. In addition, participants in the coached arm will receive 11 calls from a health coach and a single visit to their home by an exercise specialist.~Coached group: Participants randomized to the coached arm will receive 1) education and self-monitoring materials [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur"
79823|NCT02085785|P2|Participant Flow|Self-directed|"Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group, but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.~Self-directed control group: Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own."
79855|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79824|NCT02085785|P1|Participant Flow|Coached|"Participants randomized to the coached arm will receive the same educational and self-monitoring materials as the self-directed group. In addition, participants in the coached arm will receive 11 calls from a health coach and a single visit to their home by an exercise specialist.~Coached group: Participants randomized to the coached arm will receive 1) education and self-monitoring materials [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur"
79825|NCT02085785|O2|Outcome|Self-directed|"Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group, but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.~Self-directed control group: Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own."
79826|NCT02085785|O1|Outcome|Coached|"Participants randomized to the coached arm will receive the same educational and self-monitoring materials as the self-directed group. In addition, participants in the coached arm will receive 11 calls from a health coach and a single visit to their home by an exercise specialist.~Coached group: Participants randomized to the coached arm will receive 1) education and self-monitoring materials [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur"
79827|NCT02085785|O2|Outcome|Self-directed|"Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group, but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.~Self-directed control group: Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own."
79828|NCT02085785|O1|Outcome|Coached|"Participants randomized to the coached arm will receive the same educational and self-monitoring materials as the self-directed group. In addition, participants in the coached arm will receive 11 calls from a health coach and a single visit to their home by an exercise specialist.~Coached group: Participants randomized to the coached arm will receive 1) education and self-monitoring materials [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur"
79829|NCT02085785|O1|Outcome|Self-directed + Coached Combined|Intervention assessment questionnaires were not linked to other study data, so we are unable to report study group information
79830|NCT02085785|O2|Outcome|Self-directed|"Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group, but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.~Self-directed control group: Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own."
79831|NCT02085785|O1|Outcome|Coached|"Participants randomized to the coached arm will receive the same educational and self-monitoring materials as the self-directed group. In addition, participants in the coached arm will receive 11 calls from a health coach and a single visit to their home by an exercise specialist.~Coached group: Participants randomized to the coached arm will receive 1) education and self-monitoring materials [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur"
79832|NCT02085785|O1|Outcome|Overall Study Feasibility|Reporting of recruitment and eligibility for the targeted population
79833|NCT02085785|E2|Reported Event|Self-directed|"Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group, but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.~Self-directed control group: Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own."
79834|NCT02085785|E1|Reported Event|Coached|"Participants randomized to the coached arm will receive the same educational and self-monitoring materials as the self-directed group. In addition, participants in the coached arm will receive 11 calls from a health coach and a single visit to their home by an exercise specialist.~Coached group: Participants randomized to the coached arm will receive 1) education and self-monitoring materials [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur"
79835|NCT02085720|B1|Baseline|Chinese Elderly OSAS|"Subjects will be recruited in the community elderly center with home sleep study done. Those with significant OSAS will be prescribed with CPAP therapy and subsequent compliance is monitored.~CPAP therapy: As OSA may increase the risk of cardiovascular mortality, all elderly subjects with AHI ≥ 15 or those with AHI ≥ 5 plus either cardiovascular risk factors or ESS score ≥ 10 received patient education program. Elderly subjects who agree for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). ESS, sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment."
80029|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
79836|NCT02085720|P1|Participant Flow|Chinese Elderly OSAS|"We conducted a sleep questionnaire survey among the elders aged 60 years or more in the community centres followed by level 3 home sleep study (EMBLETTA). Subjects with an apnea hypopnea index (AHI) ≥ 15 alone and those with AHI ≥ 5 plus either cardiovascular risk factors or Epworth Sleepiness Score (ESS) ≥ 10 were offered continuous positive airway pressure (CPAP) treatment.~CPAP therapy: Elderly subjects who agreed for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). Epworth Sleepiness Score (ESS), sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment."
79837|NCT02085720|O1|Outcome|Sleep Heatlh Questionnaire Result|We conducted a sleep questionnaire survey among the elders aged 60 years or more in the community centres.
79838|NCT02085720|O1|Outcome|AHI Result|Subjects who had completed the questionnaires and consented for sleep study were invited to undergo a portable at-home sleep study. In the afternoon, subjects attended the pulmonary function laboratory to be fitted with the EmblettaTM portable diagnostic system (PDS, Medcare, Iceland). It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an AHI based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events. Respiratory events were scored when desaturations of at least 4% occurred in the absence of moving artifacts and irrespective of co-existing changes in snoring or heart rate. A hypopnea was defined as a decrease in airflow by 50% of baseline for at least 10 seconds. Data were included in the analysis if the total recorded evaluation time of 4 hrs or longer was obtained during the EmblettaTM PDS study.
79839|NCT02085720|O1|Outcome|Chinese Elderly OSAS|"Subjects will be recruited in the community elderly center with home sleep study done. Those with significant OSAS will be prescribed with CPAP therapy and subsequent compliance is monitored.~CPAP therapy: As OSA may increase the risk of cardiovascular mortality, all elderly subjects with AHI ≥ 15 or those with AHI ≥ 5 plus either cardiovascular risk factors or ESS score ≥ 10 received patient education program. Elderly subjects who agree for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). ESS, sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment."
79840|NCT02085720|O1|Outcome|Chinese Elderly OSAS|RLS is a disorder characterized by disagreeable leg sensations that usually occur before sleep onset, causing an almost irresistible urge to move the legs. As minimal criteria for diagnosis, the following four features were required: (1) desire to move the extremities, often associated with paresthesias and/or dysesthesias; (2) motor restlessness; (3) worsening of symptoms at rest, with at least temporary relief by activity; and (4) worsening of symptoms in the evening or at night.
79841|NCT02085720|O1|Outcome|Chinese Elderly OSAS|"We conducted a sleep questionnaire survey among the elders aged 60 years or more in the community centres followed by level 3 home sleep study (EMBLETTA). Subjects with an apnea hypopnea index (AHI) ≥ 15 alone and those with AHI ≥ 5 plus either cardiovascular risk factors or Epworth Sleepiness Score (ESS) ≥ 10 were offered continuous positive airway pressure (CPAP) treatment.~CPAP therapy: Elderly subjects who agreed for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). Epworth Sleepiness Score (ESS), sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment."
79842|NCT02085720|E1|Reported Event|Chinese Elderly OSAS|"Subjects will be recruited in the community elderly center with home sleep study done. Those with significant OSAS will be prescribed with CPAP therapy and subsequent compliance is monitored.~CPAP therapy: As OSA may increase the risk of cardiovascular mortality, all elderly subjects with AHI ≥ 15 or those with AHI ≥ 5 plus either cardiovascular risk factors or ESS score ≥ 10 received patient education program. Elderly subjects who agree for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). ESS, sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment."
79843|NCT02085161|B5|Baseline|Total|Total of all reporting groups
79844|NCT02085161|B4|Baseline|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
79845|NCT02085161|B3|Baseline|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79846|NCT02085161|B2|Baseline|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79847|NCT02085161|B1|Baseline|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79848|NCT02085161|P4|Participant Flow|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
79849|NCT02085161|P3|Participant Flow|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79850|NCT02085161|P2|Participant Flow|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79851|NCT02085161|P1|Participant Flow|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79852|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
79853|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79854|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79856|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
79857|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79858|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79859|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79860|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
79861|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79862|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79863|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79864|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
79865|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79866|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79867|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79868|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
79869|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79870|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79871|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79872|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
79873|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79874|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79875|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79876|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
79877|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79878|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79879|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79880|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
79881|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79882|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79883|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79884|NCT02085161|E5|Reported Event|Total|Total
79885|NCT02085161|E4|Reported Event|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
79886|NCT02085161|E3|Reported Event|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79887|NCT02085161|E2|Reported Event|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79888|NCT02085161|E1|Reported Event|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
79889|NCT02084797|B1|Baseline|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.~V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
79890|NCT02084797|P1|Participant Flow|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.~V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
79891|NCT02084797|O1|Outcome|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.~V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
79892|NCT02084797|O1|Outcome|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.~V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
79893|NCT02084797|O1|Outcome|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.~V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
79894|NCT02084797|O1|Outcome|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.~V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
79895|NCT02084797|E1|Reported Event|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.~V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
79896|NCT02084706|B3|Baseline|Total|Total of all reporting groups
80030|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
79897|NCT02084706|B2|Baseline|J-tip Lidocaine Administration, Then Steroid Injection|"Group two subjects will receive a needle free J-tip administration of 0.5mL of 2% lidocaine prior (2-10 minutes) to needle injection of 0.5mL of Triamcinolone (20 g) over the A1 pulley.~2% Lidocaine~Triamcinolone (20 g)~J-tip lidocaine administration~Triamcinolone (20 g) Injection over the A1 pulley."
79898|NCT02084706|B1|Baseline|Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley|"Group one subjects will receive an injection of 0.5mL (20 g) of Triamcinolone and 0.5 mL of 2% Lidocaine over the A1 pulley.~Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley~2% Lidocaine~Triamcinolone (20 g)"
79899|NCT02084706|P2|Participant Flow|J-tip Lidocaine Administration, Then Steroid Injection|"Group two subjects will receive a needle free J-tip administration of 0.5mL of 2% lidocaine prior (2-10 minutes) to needle injection of 0.5mL of Triamcinolone (20 g) over the A1 pulley.~2% Lidocaine~Triamcinolone (20 g)~J-tip lidocaine administration~Triamcinolone (20 g) Injection over the A1 pulley."
79900|NCT02084706|P1|Participant Flow|Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley|"Group one subjects will receive an injection of 0.5mL (20 g) of Triamcinolone and 0.5 mL of 2% Lidocaine over the A1 pulley.~Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley~2% Lidocaine~Triamcinolone (20 g)"
79901|NCT02084706|O2|Outcome|J-tip Lidocaine Administration, Then Steroid Injection|"Group two subjects received a needle free J-tip administration of 0.5mL of 2% lidocaine prior (2-10 minutes) to needle injection of 0.5mL of Triamcinolone (20 g) over the A1 pulley.~2% Lidocaine~Triamcinolone (20 g)~J-tip lidocaine administration~Triamcinolone (20 g) Injection over the A1 pulley."
79902|NCT02084706|O1|Outcome|Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley|"Group one subjects received an injection of 0.5mL (20 g) of Triamcinolone and 0.5 mL of 2% Lidocaine over the A1 pulley.~Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley~2% Lidocaine~Triamcinolone (20 g)"
79903|NCT02084706|E2|Reported Event|J-tip Lidocaine Administration, Then Steroid Injection|"Group two subjects received a needle free J-tip administration of 0.5mL of 2% lidocaine prior (2-10 minutes) to needle injection of 0.5mL of Triamcinolone (20 g) over the A1 pulley.~2% Lidocaine~Triamcinolone (20 g)~J-tip lidocaine administration~Triamcinolone (20 g) Injection over the A1 pulley."
79904|NCT02084706|E1|Reported Event|Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley|"Group one subjects received an injection of 0.5mL (20 g) of Triamcinolone and 0.5 mL of 2% Lidocaine over the A1 pulley.~Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley~2% Lidocaine~Triamcinolone (20 g)"
79905|NCT02084628|B1|Baseline|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
79906|NCT02084628|P1|Participant Flow|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participant to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
79907|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
79908|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
79909|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
79910|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
79911|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
79912|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
79913|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
79914|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
79915|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
79916|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
80010|NCT02084056|O1|Outcome|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
79917|NCT02084628|E1|Reported Event|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
79918|NCT02084238|B1|Baseline|Interleukin-2|"Interleukin-2 to treat activated SLE.~Interleukin-2: Patients receive low dose recombinant human Interleukin-2（HrIL-2） (1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3-6 courses according to the situation of the disease."
79919|NCT02084238|P1|Participant Flow|Interleukin-2|"Interleukin-2 to treat activated SLE.~Interleukin-2: Patients receive low dose recombinant human Interleukin-2（HrIL-2） (1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day break, another cycle started) for 3-6 courses according to the situation of the disease."
79920|NCT02084238|O1|Outcome|SLEDAI Score|SLEDAI score at week 0 and week 10.
79921|NCT02084238|O3|Outcome|Laboratory Variables 3|Serum anti-dsDNA antibodies in patients with SLE
79922|NCT02084238|O2|Outcome|Laboratory Variables 2|Serum complement 4 in SLE patients
79923|NCT02084238|O1|Outcome|Laboratory Variables 1|Serum complement 3 in SLE patients
79924|NCT02084238|O3|Outcome|Immunological Responses 3|Th17 in CD4+T cells in 23 patients with SLE
79925|NCT02084238|O2|Outcome|Immunological Responses 2|Tfh cells in CD4+ T cells in 23 patients with SLE
79926|NCT02084238|O1|Outcome|Immunological Responses 1|Treg in total CD4+T cells in 23 patients with SLE
79927|NCT02084238|O1|Outcome|SRI Results|All 38 patients who completed therapy will be calculated the response rate at each visit time point(week 2,4,6,8,10).
79928|NCT02084238|E1|Reported Event|IL-2 Therapy in SLE|All enrolled patients completed three cycles of recombinant human IL-2 (rhIL-2). In each cycle, 1 million IU rhIL-2 was administered subcutaneously every other day for 2 weeks, followed by a 2-week break.
79929|NCT02084134|B3|Baseline|Total|Total of all reporting groups
79930|NCT02084134|B2|Baseline|Non-steroid Treatment|Subjects will not receive any steroids at the time of surgery or after surgery unless symptoms of adrenal insufficiency develop (i.e. nausea, vomiting, dizziness, or low blood pressure).
79931|NCT02084134|B1|Baseline|Steroid Treatment Arm|"Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg~hydrocortisone: 100mg at the time of surgery~dexamethasone: 0.5mg every 6 hours for a total of four doses"
79932|NCT02084134|P2|Participant Flow|Non-steroid Treatment|Subjects will not receive any steroids at the time of surgery or after surgery unless symptoms of adrenal insufficiency develop (i.e. nausea, vomiting, dizziness, or low blood pressure).
79933|NCT02084134|P1|Participant Flow|Steroid Treatment Arm|"Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg~hydrocortisone: 100mg at the time of surgery~dexamethasone: 0.5mg every 6 hours for a total of four doses"
79934|NCT02084134|O2|Outcome|Non-steroid Treatment|Subjects will not receive any steroids at the time of surgery or after surgery unless symptoms of adrenal insufficiency develop (i.e. nausea, vomiting, dizziness, or low blood pressure).
79935|NCT02084134|O1|Outcome|Steroid Treatment Arm|"Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg~hydrocortisone: 100mg at the time of surgery~dexamethasone: 0.5mg every 6 hours for a total of four doses"
79936|NCT02084134|O2|Outcome|Non-steroid Treatment|Subjects will not receive any steroids at the time of surgery or after surgery unless symptoms of adrenal insufficiency develop (i.e. nausea, vomiting, dizziness, or low blood pressure).
79937|NCT02084134|O1|Outcome|Steroid Treatment Arm|"Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg~hydrocortisone: 100mg at the time of surgery~dexamethasone: 0.5mg every 6 hours for a total of four doses"
79938|NCT02084134|E2|Reported Event|Non-steroid Treatment|Subjects will not receive any steroids at the time of surgery or after surgery unless symptoms of adrenal insufficiency develop (i.e. nausea, vomiting, dizziness, or low blood pressure).
79939|NCT02084134|E1|Reported Event|Steroid Treatment Arm|"Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg~hydrocortisone: 100mg at the time of surgery~dexamethasone: 0.5mg every 6 hours for a total of four doses"
79940|NCT02084082|B3|Baseline|Total|Total of all reporting groups
79941|NCT02084082|B2|Baseline|FDC 1000 Fed or L+M 1000 Fed|"The subjects in Part 2 were randomly allocated to 1 of the 2 treatment sequences T fed_R fed or R fed_T fed.~FDC 1000 fed (T fed): 5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.~L+M 1000 fed (R fed): 5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin 1000mg"
79942|NCT02084082|B1|Baseline|FDC 1000 Fast or L+M 1000 Fast|"The subjects in Part 1 were randomly allocated to 1 of the 2 treatment sequences T fasted_R fasted or R fasted_T fasted.~FDC 1000 fast (T fasted): 5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.~L+M 1000 fast (R fasted): 5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin 1000mg"
79943|NCT02084082|P4|Participant Flow|L+M1000 Fed/ FDC1000 Fed|"Single tablets of linagliptin and metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) followed by Linagliptin/Metformin XR FDC (given as 1 FDC tablet), oral with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin 1000mg"
79944|NCT02084082|P3|Participant Flow|FDC1000 Fed/L+M1000 Fed|"Linagliptin/Metformin XR FDC (given as 1 FDC tablet) followed by single tablets of linagliptin and metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR), oral with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin 1000mg"
79945|NCT02084082|P2|Participant Flow|L+M1000 Fast/ FDC1000 Fast|"Single tablets of linagliptin and metformin Extended Release (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) followed by Linagliptin/Metformin XR Fixed Dose Combination (given as 1 FDC tablet), oral with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin 1000mg"
80482|NCT02081690|O1|Outcome|Macitentan|Macitentan tablet, dose of 10 mg, once daily
79946|NCT02084082|P1|Participant Flow|FDC 1000 Fast/ L+M 1000 Fast|"Linagliptin/Metformin Extended Release (XR) Fixed dose combination (given as 1 FDC tablet) followed by single tablets of linagliptin and metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR), oral with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin 1000mg"
79947|NCT02084082|O4|Outcome|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
79948|NCT02084082|O3|Outcome|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
79949|NCT02084082|O2|Outcome|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
79950|NCT02084082|O1|Outcome|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
79951|NCT02084082|O4|Outcome|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
79952|NCT02084082|O3|Outcome|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
79953|NCT02084082|O2|Outcome|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
79954|NCT02084082|O1|Outcome|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
79955|NCT02084082|O4|Outcome|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
79956|NCT02084082|O3|Outcome|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
79957|NCT02084082|O2|Outcome|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
79958|NCT02084082|O1|Outcome|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
79959|NCT02084082|O4|Outcome|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
79960|NCT02084082|O3|Outcome|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
79961|NCT02084082|O2|Outcome|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
79962|NCT02084082|O1|Outcome|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
79963|NCT02084082|O4|Outcome|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
79964|NCT02084082|O3|Outcome|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
79965|NCT02084082|O2|Outcome|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
79966|NCT02084082|O1|Outcome|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
79967|NCT02084082|O4|Outcome|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
79968|NCT02084082|O3|Outcome|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
79969|NCT02084082|O2|Outcome|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
79970|NCT02084082|O1|Outcome|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
79971|NCT02084082|E4|Reported Event|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
79972|NCT02084082|E3|Reported Event|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
79973|NCT02084082|E2|Reported Event|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
79974|NCT02084082|E1|Reported Event|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
79975|NCT02084069|B3|Baseline|Total|Total of all reporting groups
79976|NCT02084069|B2|Baseline|Control|Placebo
79977|NCT02084069|B1|Baseline|Treatment|Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery
79978|NCT02084069|P2|Participant Flow|Control|Placebo
79979|NCT02084069|P1|Participant Flow|Treatment|Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery
79980|NCT02084069|O2|Outcome|Control|Placebo
79981|NCT02084069|O1|Outcome|Treatment|Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery
79982|NCT02084069|E2|Reported Event|Control|Placebo
79983|NCT02084069|E1|Reported Event|Treatment|Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery
79984|NCT02084056|B3|Baseline|Total|Total of all reporting groups
79985|NCT02084056|B2|Baseline|FDC 2000 Fed or L+M 2000 Fed|"The subjects in Part 2 were randomly allocated to 1 of the 2 treatment sequences T fed_R fed or R fed_T fed.~FDC 2000 fed (T fed): 2X2.5 mg linagliptin/1000 mg metformin XR (given as FDC tablet) orally with 240 mL of water after a high-fat, high-calorie meal.~L+M 2000 fed (R fed): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
79986|NCT02084056|B1|Baseline|FDC 2000 Fasted or L+M 2000 Fasted|"The subjects in Part 1 were randomly allocated to 1 of the 2 treatment sequences T fasted_R fasted or R fasted_T fasted.~FDC 2000 fasted (T fasted): 2X2.5 mg linagliptin/1000 mg metformin XR (given as FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.~L+M 2000 fasted (R fasted): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
79987|NCT02084056|P4|Participant Flow|L+M 2000 Fed / FDC 2000 Fed|"Linagliptin+ Metformin-(R fed): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin (FDC)-(T fed): 2X2.5 mg linagliptin/1000 mg metformin XR orally with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
79988|NCT02084056|P3|Participant Flow|FDC 2000 Fed / L+M 2000 Fed|"Linagliptin+ Metformin (FDC)-(T fed): 2X2.5 mg linagliptin/1000 mg metformin XR (given as FDC tablet) followed by 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
79989|NCT02084056|P2|Participant Flow|L+M 2000 Fasted / FDC 2000 Fasted|"Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin (FDC)-(T fasted): 2X2.5 mg linagliptin/1000 mg metformin XR orally with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
79990|NCT02084056|P1|Participant Flow|FDC 2000 Fasted / L+M 2000 Fasted|"Linagliptin+ Metformin Fixed dose combination (FDC)-(T fasted): 2X2.5 mg linagliptin/1000 mg metformin Extended Release (XR) (given as FDC tablet) followed by 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
79991|NCT02084056|O4|Outcome|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
79992|NCT02084056|O3|Outcome|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
79993|NCT02084056|O2|Outcome|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
79994|NCT02084056|O1|Outcome|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
79995|NCT02084056|O4|Outcome|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
79996|NCT02084056|O3|Outcome|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
79997|NCT02084056|O2|Outcome|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
79998|NCT02084056|O1|Outcome|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
79999|NCT02084056|O4|Outcome|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
80000|NCT02084056|O3|Outcome|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
80001|NCT02084056|O2|Outcome|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
80002|NCT02084056|O1|Outcome|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
80003|NCT02084056|O4|Outcome|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
80004|NCT02084056|O3|Outcome|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
80005|NCT02084056|O2|Outcome|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
80006|NCT02084056|O1|Outcome|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
80007|NCT02084056|O4|Outcome|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
80008|NCT02084056|O3|Outcome|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
80009|NCT02084056|O2|Outcome|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
80483|NCT02081690|O1|Outcome|Macitentan|Macitentan tablet, dose of 10 mg, once daily
80011|NCT02084056|O4|Outcome|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
80012|NCT02084056|O3|Outcome|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
80013|NCT02084056|O2|Outcome|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
80014|NCT02084056|O1|Outcome|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
80015|NCT02084056|E4|Reported Event|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
80016|NCT02084056|E3|Reported Event|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
80017|NCT02084056|E2|Reported Event|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
80018|NCT02084056|E1|Reported Event|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
80019|NCT02083965|B3|Baseline|Total|Total of all reporting groups
80020|NCT02083965|B2|Baseline|rFVIIIFc 3000 / 1000|"Following the minimum 4-day washout, participants received a single injection 50 IU/kg at strength of 3000 IU/vial of rFVIIIFc (on Injection 1 Day 1) with 96 hours of PK assessments followed by a minimum of a 5-day washout prior to a second single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial (on Injection 2 Day 1) with 96 hours of PK assessments.~After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:~A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator’s discretion as needed to prevent or treat bleeding.~A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate subjects who were selected based on the opinion of the Investigator.~An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
80021|NCT02083965|B1|Baseline|rFVIIIFc 1000 / 3000|"Following the minimum 4-day washout, participants received a single injection 50 IU/kg at strength of 1000 IU/vial of rFVIIIFc (on Injection 1 Day 1) with 96 hours of PK assessments followed by a minimum of a 5-day washout prior to a second single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial (on Injection 2 Day 1) with 96 hours of PK assessments.~After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:~A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator’s discretion as needed to prevent or treat bleeding.~A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate subjects who were selected based on the opinion of the Investigator.~An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
80022|NCT02083965|P2|Participant Flow|rFVIIIFc 3000 / 1000|"Following the minimum 4-day washout, participants received a single injection 50 IU/kg at strength of 3000 IU/vial of rFVIIIFc (on Injection 1 Day 1) with 96 hours of PK assessments followed by a minimum of a 5-day washout prior to a second single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial (on Injection 2 Day 1) with 96 hours of PK assessments.~After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:~A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator’s discretion as needed to prevent or treat bleeding.~A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate subjects who were selected based on the opinion of the Investigator.~An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
80023|NCT02083965|P1|Participant Flow|rFVIIIFc 1000 / 3000|"Following a minimum 4-day washout, participants received a single injection 50 IU/kg at strength of 1000 IU/vial of rFVIIIFc (on Injection 1 Day 1) with 96 hours of pharmacokinetic (PK) assessments followed by a minimum of a 5-day washout prior to a second single injection of rFVIIIFc 50 IU/kg at strength of 3000 IU/vial (on Injection 2 Day 1) with 96 hours of PK assessments.~After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:~A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator’s discretion as needed to prevent or treat bleeding.~A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate subjects who were selected based on the opinion of the Investigator.~An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
80024|NCT02083965|O1|Outcome|rFVIIIFc|"Following the minimum 4-day washout, participants received their first injection of rFVIIIFc (on Injection 1 Day 1) rFVIIIFc 50 IU/kg at a strength of either 1000 or 3000 IU/vial. The second injection of rFVIIIFc 50 IU/kg at a strength of either 1000 or 3000 IU/vial was administered, in a crossover fashion, after a minimum of a 5-day washout (on Injection 2 Day 1).~After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:~A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator’s discretion as needed to prevent or treat bleeding.~A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate participants who were selected based on the opinion of the Investigator.~An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
80025|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
80026|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
80027|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
80028|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
80031|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
80032|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
80033|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
80034|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
80035|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
80036|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
80037|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
80038|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
80039|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
80040|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
80041|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
80042|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
80043|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
80044|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
80045|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
80046|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
80047|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
80048|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
80049|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
80050|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
80051|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
80052|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
80053|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
80054|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
80055|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
80056|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
80057|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
80058|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
80059|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
80060|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
80061|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|rFVIIIFc single injection 50 IU/kg at a strength of 3000 IU/vial
80062|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
80063|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
80064|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
80065|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
80066|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
80067|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
80068|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
80069|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
80070|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
80071|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
80072|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
80073|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
80074|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
80075|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
80076|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
80077|NCT02083965|E1|Reported Event|Total Active|"Following the minimum 4-day washout, participants received their first injection of rFVIIIFc (on Injection 1 Day 1) rFVIIIFc 50 IU/kg at a strength of either 1000 or 3000 IU/vial. The second injection of rFVIIIFc 50 IU/kg at a strength of either 1000 or 3000 IU/vial was administered, in a crossover fashion, after a minimum of a 5-day washout (on Injection 2 Day 1).~After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:~A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator’s discretion as needed to prevent or treat bleeding.~A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate participants who were selected based on the opinion of the Investigator.~An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
80078|NCT02083861|B3|Baseline|Total|Total of all reporting groups
80135|NCT02083406|E1|Reported Event|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
80079|NCT02083861|B2|Baseline|Placebo Ultrasound Device|"Patients (n=35) wear the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The placebo device appears and operates identically to the active device except that it does not emit ultrasound.~Sam Ultrasonic Diathermy Device: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2."
80080|NCT02083861|B1|Baseline|Active Ultrasound Device|"Patients (n=55) receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.~Sam Ultrasonic Diathermy Device: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2."
80081|NCT02083861|P2|Participant Flow|Placebo Ultrasound Device|"Patients (n=35) wear the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The placebo device appears and operates identically to the active device except that it does not emit ultrasound.~Sam Ultrasonic Diathermy Device: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2."
80082|NCT02083861|P1|Participant Flow|Active Ultrasound Device|"Patients (n=55) receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.~Sam Ultrasonic Diathermy Device: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2."
80083|NCT02083861|O2|Outcome|Placebo Ultrasound Device|"Patients (n=8) wear the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The placebo device appears and operates identically to the active device except that it does not emit ultrasound.~Sam Ultrasonic Diathermy Device: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2."
80084|NCT02083861|O1|Outcome|Active Ultrasound Device|"Patients (n=9) receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.~Sam Ultrasonic Diathermy Device: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2."
80085|NCT02083861|O2|Outcome|Placebo Ultrasound Device|"Patients (n=8) wear the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The placebo device appears and operates identically to the active device except that it does not emit ultrasound.~Sam Ultrasonic Diathermy Device: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2."
80086|NCT02083861|O1|Outcome|Active Ultrasound Device|"Patients (n=9) receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.~Sam Ultrasonic Diathermy Device: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2."
80087|NCT02083861|O2|Outcome|Placebo Ultrasound Device|"Patients (n=35) wear the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The placebo device appears and operates identically to the active device except that it does not emit ultrasound.~Sam Ultrasonic Diathermy Device: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2."
80088|NCT02083861|O1|Outcome|Active Ultrasound Device|"Patients (n=55) receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.~Sam Ultrasonic Diathermy Device: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2."
80089|NCT02083861|O2|Outcome|Placebo Ultrasound Device|"Patients (n=35) wear the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The placebo device appears and operates identically to the active device except that it does not emit ultrasound.~Sam Ultrasonic Diathermy Device: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2."
80090|NCT02083861|O1|Outcome|Active Ultrasound Device|"Patients (n=55) receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.~Sam Ultrasonic Diathermy Device: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2."
80091|NCT02083861|E2|Reported Event|Placebo Ultrasound Device|"Patients (n=35) wear the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The placebo device appears and operates identically to the active device except that it does not emit ultrasound.~Sam Ultrasonic Diathermy Device: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2."
80092|NCT02083861|E1|Reported Event|Active Ultrasound Device|"Patients (n=55) receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.~Sam Ultrasonic Diathermy Device: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2."
80093|NCT02083679|B5|Baseline|Total|Total of all reporting groups
80094|NCT02083679|B4|Baseline|Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg on Day 1 and 12 mg/kg on Day 8 of a 3-Week cycle until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin AUC = 6 mg/mL/min plus paclitaxel 225 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
80136|NCT02083380|B4|Baseline|Total|Total of all reporting groups
80137|NCT02083380|B3|Baseline|C) Artefenomel 800mg: PQP 1440mg|Artefenomel 800mg: Piperaquine 1440mg
80138|NCT02083380|B2|Baseline|B) Artefenomel 800mg: PQP 960mg|Artefenomel 800mg: Piperaquine 960mg
80139|NCT02083380|B1|Baseline|A) Artefenomel 800mg: PQP 640mg|Artefenomel 800mg: Piperaquine 640mg
80095|NCT02083679|B3|Baseline|Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin area under the concentration-time curve (AUC) = 6 milligram per millilitre per minute [mg/mL/min] plus paclitaxel 225 mg/m^2 on Day 1 of 3-Week cycle intravenously for a maximum of 6 treatment cycles).
80096|NCT02083679|B2|Baseline|Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of cisplatin/pemetrexed (cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
80097|NCT02083679|B1|Baseline|Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine|Sym004 administered as an intravenous infusion at a dose of 6 milligram per kilogram (mg/kg) weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the investigational medicinal product (IMP) in combination with platinum-doublet chemotherapy regimen of cisplatin/gemcitabine (cisplatin 75 milligram per meter square (mg/m^2) on Day 1 plus gemcitabine 1250 mg/m^2 on Days 1 and 8 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
80098|NCT02083679|P4|Participant Flow|Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg on Day 1 and 12 mg/kg on Day 8 of a 3-Week cycle until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin AUC = 6 mg/mL/min plus paclitaxel 225 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
80099|NCT02083679|P3|Participant Flow|Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin area under the concentration-time curve (AUC) = 6 milligram per millilitre per minute [mg/mL/min] plus paclitaxel 225 mg/m^2 on Day 1 of 3-Week cycle intravenously for a maximum of 6 treatment cycles).
80100|NCT02083679|P2|Participant Flow|Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of cisplatin/pemetrexed (cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
80101|NCT02083679|P1|Participant Flow|Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine|Sym004 administered as an intravenous infusion at a dose of 6 milligram per kilogram (mg/kg) weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the investigational medicinal product (IMP) in combination with platinum-doublet chemotherapy regimen of cisplatin/gemcitabine (cisplatin 75 milligram per meter square (mg/m^2) on Day 1 plus gemcitabine 1250 mg/m^2 on Days 1 and 8 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
80102|NCT02083679|O4|Outcome|Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg on Day 1 and 12 mg/kg on Day 8 of a 3-Week cycle until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin AUC = 6 mg/mL/min plus paclitaxel 225 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
80103|NCT02083679|O3|Outcome|Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin area under the concentration-time curve (AUC) = 6 milligram per millilitre per minute [mg/mL/min] plus paclitaxel 225 mg/m^2 on Day 1 of 3-Week cycle intravenously for a maximum of 6 treatment cycles).
80104|NCT02083679|O2|Outcome|Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of cisplatin/pemetrexed (cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
80105|NCT02083679|O1|Outcome|Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine|Sym004 administered as an intravenous infusion at a dose of 6 milligram per kilogram (mg/kg) weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the investigational medicinal product (IMP) in combination with platinum-doublet chemotherapy regimen of cisplatin/gemcitabine (cisplatin 75 milligram per meter square (mg/m^2) on Day 1 plus gemcitabine 1250 mg/m^2 on Days 1 and 8 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
80106|NCT02083679|O4|Outcome|Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg on Day 1 and 12 mg/kg on Day 8 of a 3-Week cycle until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin AUC = 6 mg/mL/min plus paclitaxel 225 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
80140|NCT02083380|P3|Participant Flow|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80141|NCT02083380|P2|Participant Flow|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80142|NCT02083380|P1|Participant Flow|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80107|NCT02083679|O3|Outcome|Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin area under the concentration-time curve (AUC) = 6 milligram per millilitre per minute [mg/mL/min] plus paclitaxel 225 mg/m^2 on Day 1 of 3-Week cycle intravenously for a maximum of 6 treatment cycles).
80108|NCT02083679|O2|Outcome|Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of cisplatin/pemetrexed (cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
80109|NCT02083679|O1|Outcome|Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine|Sym004 administered as an intravenous infusion at a dose of 6 milligram per kilogram (mg/kg) weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the investigational medicinal product (IMP) in combination with platinum-doublet chemotherapy regimen of cisplatin/gemcitabine (cisplatin 75 milligram per meter square (mg/m^2) on Day 1 plus gemcitabine 1250 mg/m^2 on Days 1 and 8 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
80110|NCT02083679|E4|Reported Event|Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg on Day 1 and 12 mg/kg on Day 8 of a 3-Week cycle until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin AUC = 6 mg/mL/min plus paclitaxel 225 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
80111|NCT02083679|E3|Reported Event|Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin area under the concentration-time curve (AUC) = 6 milligram per millilitre per minute [mg/mL/min] plus paclitaxel 225 mg/m^2 on Day 1 of 3-Week cycle intravenously for a maximum of 6 treatment cycles).
80112|NCT02083679|E2|Reported Event|Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of cisplatin/pemetrexed (cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
80113|NCT02083679|E1|Reported Event|Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine|Sym004 administered as an intravenous infusion at a dose of 6 milligram per kilogram (mg/kg) weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the investigational medicinal product (IMP) in combination with platinum-doublet chemotherapy regimen of cisplatin/gemcitabine (cisplatin 75 milligram per meter square (mg/m^2) on Day 1 plus gemcitabine 1250 mg/m^2 on Days 1 and 8 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
80114|NCT02083406|B4|Baseline|Total|Total of all reporting groups
80115|NCT02083406|B3|Baseline|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
80116|NCT02083406|B2|Baseline|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
80117|NCT02083406|B1|Baseline|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
80118|NCT02083406|P3|Participant Flow|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
80119|NCT02083406|P2|Participant Flow|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
80120|NCT02083406|P1|Participant Flow|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
80121|NCT02083406|O3|Outcome|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
80122|NCT02083406|O2|Outcome|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
80123|NCT02083406|O1|Outcome|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
80124|NCT02083406|O3|Outcome|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
80125|NCT02083406|O2|Outcome|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
80126|NCT02083406|O1|Outcome|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
80127|NCT02083406|O3|Outcome|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
80128|NCT02083406|O2|Outcome|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
80129|NCT02083406|O1|Outcome|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
80130|NCT02083406|O3|Outcome|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
80131|NCT02083406|O2|Outcome|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
80132|NCT02083406|O1|Outcome|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
80133|NCT02083406|E3|Reported Event|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
80134|NCT02083406|E2|Reported Event|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
80143|NCT02083380|O1|Outcome|A) Artefenomel 800mg: PQP 640mg, 960mg & 1440mg|Artefenomel 800mg: Piperaquine phosphate 640mg, 960mg & 1440mg combined
80144|NCT02083380|O1|Outcome|A) Artefenomel 800mg: PQP 640mg, 960mg & 1440mg|Artefenomel 800mg: Piperaquine phosphate 640mg, 960mg & 1440mg combined
80145|NCT02083380|O1|Outcome|A) Artefenomel 800mg: PQP 640mg, 960mg & 1440mg|Artefenomel 800mg: Piperaquine phosphate 640mg, 960mg & 1440mg combined
80146|NCT02083380|O1|Outcome|A) Artefenomel 800mg: PQP 640mg, 960mg & 1440mg|"Artefenomel 800mg: Piperaquine phosphate 640mg, 960mg & 1440mg combined~Artefenomel 800mg: PQP 640mg, 960mg & 1440mg"
80147|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80148|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80149|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80150|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80151|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80152|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80153|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80154|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80155|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80156|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80157|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80158|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80159|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80160|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80161|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80162|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80163|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80164|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80165|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80166|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80167|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80168|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80169|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80170|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80171|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80172|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80173|NCT02083380|O1|Outcome|A) Arttefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80174|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80175|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80176|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80177|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80178|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80179|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80180|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80181|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80182|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80183|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80184|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80185|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80186|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80187|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80188|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80189|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80190|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80191|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80192|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80193|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80194|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80195|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80196|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80197|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80198|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80199|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80200|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80201|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|C) Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80202|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80203|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80204|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80205|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80206|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80207|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80208|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80209|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80210|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80211|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80212|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80213|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80214|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80215|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80216|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80217|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80218|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80219|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80220|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80221|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80222|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80223|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80224|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80225|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80226|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80227|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
80228|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
80229|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
80230|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: piperaquine 640mg: Active, loose combination
80231|NCT02083380|E3|Reported Event|C) Artefenomel 800mg: PQP 1440mg|Artefenomel 800mg: Piperaquine 1440mg
80232|NCT02083380|E2|Reported Event|B) Artefenomel 800mg: PQP 960mg|Artefenomel 800mg: Piperaquine 960mg
80233|NCT02083380|E1|Reported Event|A) Artefenomel 800mg: PQP 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg
80234|NCT02083263|B3|Baseline|Total|Total of all reporting groups
80235|NCT02083263|B2|Baseline|PEP Mask|"PEP mask, 3 months~PEP mask: 3 months"
80236|NCT02083263|B1|Baseline|Bilevel|"Bilevel, 3 months~Bilevel: 3 months"
80237|NCT02083263|P2|Participant Flow|PEP Mask|"PEP mask, 3 months~PEP mask: 3 months"
80238|NCT02083263|P1|Participant Flow|Bilevel|"Bilevel, 3 months~Bilevel: 3 months"
80239|NCT02083263|O2|Outcome|PEP Mask|"PEP mask, 3 months~PEP mask: 3 months"
80240|NCT02083263|O1|Outcome|Bilevel|"Bilevel, 3 months~Bilevel: 3 months"
80241|NCT02083263|E2|Reported Event|PEP Mask|"PEP mask, 3 months~PEP mask: 3 months"
80242|NCT02083263|E1|Reported Event|Bilevel|"Bilevel, 3 months~Bilevel: 3 months"
80243|NCT02083185|B4|Baseline|Total|Total of all reporting groups
80244|NCT02083185|B3|Baseline|Leuprorelin 22.5 mg|Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
80245|NCT02083185|B2|Baseline|Relugolix 120 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80246|NCT02083185|B1|Baseline|Relugolix 80 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80247|NCT02083185|P3|Participant Flow|Leuprorelin 22.5 mg|Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
80248|NCT02083185|P2|Participant Flow|Relugolix 120 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80249|NCT02083185|P1|Participant Flow|Relugolix 80 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80250|NCT02083185|O3|Outcome|Leuprorelin 22.5 mg|Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
80251|NCT02083185|O2|Outcome|Relugolix 120 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80252|NCT02083185|O1|Outcome|Relugolix 80 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80253|NCT02083185|O3|Outcome|Leuprorelin 22.5 mg|Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
80254|NCT02083185|O2|Outcome|Relugolix 120 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80255|NCT02083185|O1|Outcome|Relugolix 80 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80256|NCT02083185|O3|Outcome|Leuprorelin 22.5 mg|Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
80257|NCT02083185|O2|Outcome|Relugolix 120 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80258|NCT02083185|O1|Outcome|Relugolix 80 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80259|NCT02083185|O3|Outcome|Leuprorelin 22.5 mg|Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
80260|NCT02083185|O2|Outcome|Relugolix 120 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80261|NCT02083185|O1|Outcome|Relugolix 80 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80262|NCT02083185|O3|Outcome|Leuprorelin 22.5 mg|Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
80263|NCT02083185|O2|Outcome|Relugolix 120 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80264|NCT02083185|O1|Outcome|Relugolix 80 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80265|NCT02083185|O3|Outcome|Leuprorelin 22.5 mg|Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
80266|NCT02083185|O2|Outcome|Relugolix 120 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80267|NCT02083185|O1|Outcome|Relugolix 80 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80268|NCT02083185|O2|Outcome|Relugolix 120 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80269|NCT02083185|O1|Outcome|Relugolix 80 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80270|NCT02083185|O3|Outcome|Leuprorelin 22.5 mg|Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
80271|NCT02083185|O2|Outcome|Relugolix 120 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80272|NCT02083185|O1|Outcome|Relugolix 80 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80273|NCT02083185|O3|Outcome|Leuprorelin 22.5 mg|Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
80274|NCT02083185|O2|Outcome|Relugolix 120 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80275|NCT02083185|O1|Outcome|Relugolix 80 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80276|NCT02083185|O3|Outcome|Leuprorelin 22.5 mg|Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
80277|NCT02083185|O2|Outcome|Relugolix 120 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80278|NCT02083185|O1|Outcome|Relugolix 80 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80279|NCT02083185|O3|Outcome|Leuprorelin 22.5 mg|Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
80280|NCT02083185|O2|Outcome|Relugolix 120 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80281|NCT02083185|O1|Outcome|Relugolix 80 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80282|NCT02083185|O3|Outcome|Leuprorelin 22.5 mg|Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
80283|NCT02083185|O2|Outcome|Relugolix 120 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80284|NCT02083185|O1|Outcome|Relugolix 80 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80285|NCT02083185|O3|Outcome|Leuprorelin 22.5 mg|Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
80286|NCT02083185|O2|Outcome|Relugolix 120 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80287|NCT02083185|O1|Outcome|Relugolix 80 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80288|NCT02083185|O3|Outcome|Leuprorelin 22.5 mg|Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
80289|NCT02083185|O2|Outcome|Relugolix 120 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80290|NCT02083185|O1|Outcome|Relugolix 80 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80291|NCT02083185|O3|Outcome|Leuprorelin 22.5 mg|Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
80292|NCT02083185|O2|Outcome|Relugolix 120 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80293|NCT02083185|O1|Outcome|Relugolix 80 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80294|NCT02083185|O3|Outcome|Leuprorelin 22.5 mg|Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
80295|NCT02083185|O2|Outcome|Relugolix 120 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80296|NCT02083185|O1|Outcome|Relugolix 80 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80297|NCT02083185|O3|Outcome|Leuprorelin 22.5 mg|Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
80298|NCT02083185|O2|Outcome|Relugolix 120 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80473|NCT02081859|O1|Outcome|Conventional Grading|"Embryos will be scored based on conventional criteria.~Conventional Criteria"
80299|NCT02083185|O1|Outcome|Relugolix 80 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80300|NCT02083185|E3|Reported Event|Leuprorelin 22.5 mg|Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
80301|NCT02083185|E2|Reported Event|Relugolix 120 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80302|NCT02083185|E1|Reported Event|Relugolix 80 mg|Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator’s discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion.
80303|NCT02083107|B4|Baseline|Total|Total of all reporting groups
80304|NCT02083107|B3|Baseline|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
80305|NCT02083107|B2|Baseline|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
80306|NCT02083107|B1|Baseline|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
80307|NCT02083107|P3|Participant Flow|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
80308|NCT02083107|P2|Participant Flow|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
80309|NCT02083107|P1|Participant Flow|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
80310|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
80311|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
80312|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
80313|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
80314|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
80315|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
80316|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
80317|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
80318|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
80319|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
80320|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
80321|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
80322|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
80323|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
80324|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
80325|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
80326|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
80327|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
80328|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
80329|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
80479|NCT02081690|P1|Participant Flow|Macitentan|Subjects received Macitentan at a 10 mg oral dose, once daily during 16 weeks
80330|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
80331|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
80332|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
80333|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
80334|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
80335|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
80336|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
80337|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
80338|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
80339|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
80340|NCT02083107|E3|Reported Event|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
80341|NCT02083107|E2|Reported Event|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
80342|NCT02083107|E1|Reported Event|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
80343|NCT02082912|B3|Baseline|Total|Total of all reporting groups
80344|NCT02082912|B2|Baseline|Placebo|Subjects will take a placebo pill and use the HandMentor Pro for robotic therapy
80345|NCT02082912|B1|Baseline|D-cycloserine|Subjects will take D-cycloserine and use the HandMentor Pro for robotic therapy
80346|NCT02082912|P2|Participant Flow|Placebo|Subjects will take a placebo pill and use the HandMentor Pro for robotic therapy
80347|NCT02082912|P1|Participant Flow|D-cycloserine|Subjects will take D-cycloserine and use the HandMentor Pro for robotic therapy
80348|NCT02082912|O2|Outcome|Placebo|Subjects will take a placebo pill and use the HandMentor Pro for robotic therapy
80349|NCT02082912|O1|Outcome|D-cycloserine|Subjects will take D-cycloserine and use the HandMentor Pro for robotic therapy
80350|NCT02082912|E2|Reported Event|Placebo|Subjects will take a placebo pill and use the HandMentor Pro for robotic therapy
80351|NCT02082912|E1|Reported Event|D-cycloserine|Subjects will take D-cycloserine and use the HandMentor Pro for robotic therapy
80352|NCT02082769|B4|Baseline|Total|Total of all reporting groups
80353|NCT02082769|B3|Baseline|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks~Allopurinol"
80354|NCT02082769|B2|Baseline|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks~Febuxostat"
80355|NCT02082769|B1|Baseline|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks~Febuxostat"
80356|NCT02082769|P3|Participant Flow|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks~Allopurinol"
80357|NCT02082769|P2|Participant Flow|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks~Febuxostat"
80358|NCT02082769|P1|Participant Flow|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks~Febuxostat"
80359|NCT02082769|O3|Outcome|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks~Allopurinol"
80360|NCT02082769|O2|Outcome|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks~Febuxostat"
80361|NCT02082769|O1|Outcome|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks~Febuxostat"
80362|NCT02082769|O3|Outcome|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks~Allopurinol"
80363|NCT02082769|O2|Outcome|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks~Febuxostat"
80364|NCT02082769|O1|Outcome|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks~Febuxostat"
80365|NCT02082769|O3|Outcome|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks~Allopurinol"
80366|NCT02082769|O2|Outcome|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks~Febuxostat"
80367|NCT02082769|O1|Outcome|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks~Febuxostat"
80368|NCT02082769|E3|Reported Event|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks~Allopurinol"
80369|NCT02082769|E2|Reported Event|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks~Febuxostat"
80370|NCT02082769|E1|Reported Event|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks~Febuxostat"
80371|NCT02082392|B3|Baseline|Total|Total of all reporting groups
80372|NCT02082392|B2|Baseline|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.~Escitalopram"
80474|NCT02081859|O2|Outcome|Embryoscope Data|"Embryos will be scored based on both conventional rating and embryoscope data.~Embryoscope: The embryoscope is a microscope that allows for continuous time-lapse monitoring."
80373|NCT02082392|B1|Baseline|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.~Escitalopram"
80374|NCT02082392|P2|Participant Flow|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.~Escitalopram"
80375|NCT02082392|P1|Participant Flow|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.~Escitalopram"
80376|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.~Escitalopram"
80377|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.~Escitalopram"
80378|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.~Escitalopram"
80379|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.~Escitalopram"
80380|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.~Escitalopram"
80381|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.~Escitalopram"
80382|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.~Escitalopram"
80383|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.~Escitalopram"
80384|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.~Escitalopram"
80385|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.~Escitalopram"
80386|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.~Escitalopram"
80387|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.~Escitalopram"
80388|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.~Escitalopram"
80389|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.~Escitalopram"
80390|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.~Escitalopram"
80391|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.~Escitalopram"
80392|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.~Escitalopram"
80393|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.~Escitalopram"
80394|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.~Escitalopram"
80395|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.~Escitalopram"
80396|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.~Escitalopram"
80397|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.~Escitalopram"
80398|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.~Escitalopram"
80399|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.~Escitalopram"
80400|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.~Escitalopram"
80475|NCT02081859|O1|Outcome|Conventional Grading|"Embryos will be scored based on conventional criteria.~Conventional Criteria"
80401|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.~Escitalopram"
80402|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.~Escitalopram"
80403|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.~Escitalopram"
80404|NCT02082392|E2|Reported Event|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.~Escitalopram"
80405|NCT02082392|E1|Reported Event|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.~Escitalopram"
80406|NCT02082288|B1|Baseline|Edessy ICSI Outcome Embryo Score|"Edessy ICSI Outcome Embryo Score: EIOS:~Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)"
80407|NCT02082288|P1|Participant Flow|Edessy ICSI Outcome Embryo Score|"Edessy ICSI Outcome Embryo Score: EIOS:~Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)"
80408|NCT02082288|O1|Outcome|Edessy ICSI Outcome Embryo Score|"Edessy ICSI Outcome Embryo Score: EIOS:~Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)"
80409|NCT02082288|E1|Reported Event|Edessy ICSI Outcome Embryo Score|"Edessy ICSI Outcome Embryo Score: EIOS:~Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)"
80410|NCT02082262|B1|Baseline|AGN-229666|One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
80411|NCT02082262|P1|Participant Flow|AGN-229666|One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
80412|NCT02082262|O1|Outcome|AGN-229666|One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
80413|NCT02082262|E1|Reported Event|AGN-229666|One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
80414|NCT02082184|B3|Baseline|Total|Total of all reporting groups
80415|NCT02082184|B2|Baseline|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
80416|NCT02082184|B1|Baseline|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
80417|NCT02082184|P2|Participant Flow|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
80418|NCT02082184|P1|Participant Flow|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
80419|NCT02082184|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
80420|NCT02082184|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
80476|NCT02081859|E2|Reported Event|Embryoscope Data|"Embryos will be scored based on both conventional rating and embryoscope data.~Embryoscope: The embryoscope is a microscope that allows for continuous time-lapse monitoring."
80477|NCT02081859|E1|Reported Event|Conventional Grading|"Embryos will be scored based on conventional criteria.~Conventional Criteria"
80421|NCT02082184|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
80422|NCT02082184|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
80423|NCT02082184|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
80424|NCT02082184|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
80425|NCT02082184|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
80426|NCT02082184|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
80427|NCT02082184|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
80428|NCT02082184|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
80429|NCT02082184|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
80430|NCT02082184|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
80431|NCT02082184|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
80432|NCT02082184|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
80433|NCT02082184|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
80434|NCT02082184|E2|Reported Event|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
80435|NCT02082184|E1|Reported Event|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
80436|NCT02082158|B7|Baseline|Total|Total of all reporting groups
80437|NCT02082158|B6|Baseline|Prototype 4 Respirator Design|"Subjects randomized to a novel respirator design will wear that model while participating in study activities.~Novel Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
80438|NCT02082158|B5|Baseline|Prototype 3 Respirator Design|"Subjects randomized to a novel respirator design will wear that model while participating in study activities.~Novel Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
80439|NCT02082158|B4|Baseline|Prototype 2 Respirator Design|"Subjects randomized to a novel respirator design will wear that model while participating in study activities.~Novel Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
80440|NCT02082158|B3|Baseline|Prototype 1 Respirator Design|"Subjects randomized to a novel respirator design will wear that model while participating in study activities.~Novel Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
80441|NCT02082158|B2|Baseline|Non-Local Respirator Model|"Subjects randomized to a current respirator design will wear that model while participating in study activities.~Current Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
80442|NCT02082158|B1|Baseline|Local Respirator Model|"Subjects randomized to a current respirator model will wear that model while participating in study activities.~Current Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
80443|NCT02082158|P6|Participant Flow|Prototype 4 Respirator Design|"Subjects randomized to Prototype 4 respirator design will wear that model while participating in study activities.~Prototype 4 Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
80444|NCT02082158|P5|Participant Flow|Prototype 3 Respirator Design|"Subjects randomized to Prototype 3 respirator design will wear that model while participating in study activities.~Prototype 3 Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
80445|NCT02082158|P4|Participant Flow|Prototype 2 Respirator Design|"Subjects randomized to Prototype 2 respirator design will wear that model while participating in study activities.~Prototype 2 Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
80446|NCT02082158|P3|Participant Flow|Prototype 1 Respirator Design|"Subjects randomized to Prototype 1 respirator design will wear that model while participating in study activities.~Prototype 1 Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
80447|NCT02082158|P2|Participant Flow|Non-Local Respirator Model|"Subjects randomized to the non-local respirator design will wear that model while participating in study activities.~Non-Local Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.~Novel Respirator Design"
80448|NCT02082158|P1|Participant Flow|Local Respirator Model|"Subjects randomized to the local respirator model will wear that model while participating in study activities.~Local Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.~Novel Respirator Design"
80449|NCT02082158|O6|Outcome|Prototype 4 Respirator Design|"Subjects randomized to a novel respirator design will wear that respirator while participating in study activities.~Prototype 4 Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
80478|NCT02081690|B1|Baseline|Macitentan|Macitentan tablet, dose of 10 mg, once daily
80450|NCT02082158|O5|Outcome|Prototype 3 Respirator Design|"Subjects randomized to a novel respirator design will wear that respirator while participating in study activities.~Prototype 3 Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
80451|NCT02082158|O4|Outcome|Prototype 2 Respirator Design|"Subjects randomized to a novel respirator design will wear that respirator while participating in study activities.~Prototype 2 Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
80452|NCT02082158|O3|Outcome|Prototype 1 Respirator Design|"Subjects randomized to a novel respirator design will wear that respirator while participating in study activities.~Prototype 1 Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
80453|NCT02082158|O2|Outcome|Non-Local Respirator Model|"Subjects randomized to a non-local respirator model will wear that model while participating in study activities.~Non-Local Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.~Novel Respirator Design"
80454|NCT02082158|O1|Outcome|Local Respirator Model|"Subjects randomized to a current respirator model will wear that model while participating in study activities.~Local Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.~Novel Respirator Design"
80455|NCT02082158|O6|Outcome|Prototype 4 Respirator Design|"Subjects randomized to the Prototype 4 respirator design will wear that respirator while participating in study activities.~Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
80456|NCT02082158|O5|Outcome|Prototype 3 Respirator Design|"Subjects randomized to the Prototype 3 respirator design will wear that respirator while participating in study activities.~Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
80457|NCT02082158|O4|Outcome|Prototype 2 Respirator Design|"Subjects randomized to the Prototype 2 respirator design will wear that respirator while participating in study activities.~Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
80458|NCT02082158|O3|Outcome|Prototype 1 Respirator Design|"Subjects randomized to the Prototype 1 respirator design will wear that respirator while participating in study activities.~Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
80459|NCT02082158|O2|Outcome|Non-Local Respirator Model|"Subjects randomized to the non-local respirator model will wear that model while participating in study activities.~Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
80460|NCT02082158|O1|Outcome|Local Respirator Model|"Subjects randomized to the local respirator model will wear that model while participating in study activities.~Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
80461|NCT02082158|E6|Reported Event|Prototype 4 Respirator Design|Subjects randomized to Prototype 4 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
80462|NCT02082158|E5|Reported Event|Prototype 3 Respirator Design|Subjects randomized to Prototype 3 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
80463|NCT02082158|E4|Reported Event|Prototype 2 Respirator Design|Subjects randomized to Prototype 2 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
80464|NCT02082158|E3|Reported Event|Prototype 1 Respirator Design|Subjects randomized to Prototype 1 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
80465|NCT02082158|E2|Reported Event|Non-Local Respirator Model|Subjects randomized to the non-local respirator will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
80466|NCT02082158|E1|Reported Event|Local Respirator Model|Subjects randomized to the local respirator will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
80467|NCT02081859|B3|Baseline|Total|Total of all reporting groups
80468|NCT02081859|B2|Baseline|Embryoscope Data|"Embryos will be scored based on both conventional rating and embryoscope data.~Embryoscope: The embryoscope is a microscope that allows for continuous time-lapse monitoring."
80469|NCT02081859|B1|Baseline|Conventional Grading|"Embryos will be scored based on conventional criteria.~Conventional Criteria"
80470|NCT02081859|P2|Participant Flow|Embryoscope Data|"Embryos will be scored based on both conventional rating and embryoscope data.~Embryoscope: The embryoscope is a microscope that allows for continuous time-lapse monitoring."
80471|NCT02081859|P1|Participant Flow|Conventional Grading|"Embryos will be scored based on conventional criteria.~Conventional Criteria"
80472|NCT02081859|O2|Outcome|Embryoscope Data|"Embryos will be scored based on both conventional rating and embryoscope data.~Embryoscope: The embryoscope is a microscope that allows for continuous time-lapse monitoring."
80484|NCT02081690|E1|Reported Event|Macitentan|Macitentan tablet, dose of 10 mg, once daily
80485|NCT02081677|B5|Baseline|Total|Total of all reporting groups
80486|NCT02081677|B4|Baseline|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
80487|NCT02081677|B3|Baseline|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
80488|NCT02081677|B2|Baseline|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
80489|NCT02081677|B1|Baseline|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
80490|NCT02081677|P4|Participant Flow|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
80491|NCT02081677|P3|Participant Flow|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
80492|NCT02081677|P2|Participant Flow|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
80493|NCT02081677|P1|Participant Flow|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
80494|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
80495|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
80496|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
80497|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
80498|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
80499|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
80500|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
80501|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
80502|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
80503|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
80504|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
80505|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
80506|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
80507|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
80508|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
80509|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
80510|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
80511|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
80512|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
80513|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
80514|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
80515|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
80516|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
80517|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
80518|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
80519|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
80520|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
80521|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
80522|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
80523|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
80524|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
80525|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
80526|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
80527|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
80528|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
80529|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
80530|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
81136|NCT02077374|O2|Outcome|Placebo|"Placebo~Matching Placebo BID for 28 days"
80531|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
80532|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
80533|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
80534|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
80535|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
80536|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
80537|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
80538|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
80539|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
80540|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
80541|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
80542|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
80543|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
80544|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
80545|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
80546|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
80547|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
80548|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
80549|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
80550|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
80551|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
80552|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
80553|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
80554|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
80555|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
80556|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
80557|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
80558|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
80559|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
80560|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
80561|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
80562|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
80563|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
80564|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
80565|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
80566|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
80567|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
80568|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
80569|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
80570|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
80571|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
80572|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
80573|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
80574|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
80575|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
80576|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
80577|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
80578|NCT02081677|E4|Reported Event|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
80579|NCT02081677|E3|Reported Event|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
80580|NCT02081677|E2|Reported Event|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
80581|NCT02081677|E1|Reported Event|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
80582|NCT02081599|B3|Baseline|Total|Total of all reporting groups
80583|NCT02081599|B2|Baseline|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
80584|NCT02081599|B1|Baseline|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
80585|NCT02081599|P2|Participant Flow|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
80586|NCT02081599|P1|Participant Flow|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
80587|NCT02081599|O2|Outcome|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
80588|NCT02081599|O1|Outcome|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
80589|NCT02081599|O2|Outcome|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
80590|NCT02081599|O1|Outcome|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
80591|NCT02081599|O2|Outcome|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
80592|NCT02081599|O1|Outcome|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
80593|NCT02081599|O2|Outcome|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
80594|NCT02081599|O1|Outcome|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
80595|NCT02081599|E4|Reported Event|Teneli (Teneligliptin) /Teneli + Insulin(Data Through Week 52)|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 0 to Week 52 were shown.
80596|NCT02081599|E3|Reported Event|Placebo/Teneli(Teneligliptin)+Insulin(Data From Week 16 to 52)|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 16 to Week 52 were shown.
80597|NCT02081599|E2|Reported Event|Teneli (Teneligliptin)/Teneli + Insulin(Data Through Week 16)|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 0 to Week 16 were shown.
80598|NCT02081599|E1|Reported Event|Placebo/Teneli (Teneligliptin) + Insulin(Data Through Week 16)|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 0 to Week 16 were shown.
80599|NCT02081586|B5|Baseline|Total|Total of all reporting groups
80600|NCT02081586|B4|Baseline|Treatment as Usual|"Patients will remain in usual care and not receive study intervention.~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80601|NCT02081586|B3|Baseline|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80645|NCT02081443|P2|Participant Flow|Ticagrelor 90mg|The proposed study has a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy were randomly assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays were done following in vitro incubation with and without 500 nM cangrelor.
81137|NCT02077374|O1|Outcome|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
80602|NCT02081586|B2|Baseline|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80603|NCT02081586|B1|Baseline|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80604|NCT02081586|P4|Participant Flow|Treatment as Usual|"Patients will remain in usual care and not receive study intervention.~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80605|NCT02081586|P3|Participant Flow|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80606|NCT02081586|P2|Participant Flow|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80607|NCT02081586|P1|Participant Flow|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80608|NCT02081586|O4|Outcome|Treatment as Usual|"Patients will remain in usual care and not receive study intervention.~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80609|NCT02081586|O3|Outcome|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80610|NCT02081586|O2|Outcome|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80611|NCT02081586|O1|Outcome|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80612|NCT02081586|O4|Outcome|Treatment as Usual|"Patients will remain in usual care and not receive study intervention.~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80613|NCT02081586|O3|Outcome|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80614|NCT02081586|O2|Outcome|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80615|NCT02081586|O1|Outcome|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80616|NCT02081586|O4|Outcome|Standard Diabetes Care at PCP|"Patients will remain in usual care and not receive study intervention. This will include usual diabetes care at PCP.~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80617|NCT02081586|O3|Outcome|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80618|NCT02081586|O2|Outcome|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80619|NCT02081586|O1|Outcome|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80620|NCT02081586|O5|Outcome|Participants Administered Phone CBT|This includes the 3 treatment arms who received Phone CBT, whether CBT treatment was 6, 8, or 12 weeks long.
80621|NCT02081586|O4|Outcome|Treatment as Usual|"Patients will remain in usual care and not receive study intervention.~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80622|NCT02081586|O3|Outcome|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80623|NCT02081586|O2|Outcome|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80624|NCT02081586|O1|Outcome|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80625|NCT02081586|O4|Outcome|Treatment as Usual|"Patients will remain in usual care and not receive study intervention.~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80626|NCT02081586|O3|Outcome|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80627|NCT02081586|O2|Outcome|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80646|NCT02081443|P1|Participant Flow|Ticagrelor 180mg|The proposed study have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy were randomly assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays was done following in vitro incubation with and without 500 nM cangrelor.
81138|NCT02077374|E2|Reported Event|Placebo|"Placebo~Matching Placebo BID for 28 days"
80628|NCT02081586|O1|Outcome|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80629|NCT02081586|E4|Reported Event|Treatment as Usual|"Patients will remain in usual care and not receive study intervention.~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80630|NCT02081586|E3|Reported Event|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80631|NCT02081586|E2|Reported Event|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80632|NCT02081586|E1|Reported Event|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
80633|NCT02081573|B1|Baseline|Brief CBT|During the course of the twice/month diabetes management phone sessions, over 3-4 months, the nurse care manager will work collaboratively with the patient to identify a dysfunctional belief that may be affecting adherence and could be improved by a brief CBT intervention (5-7 minutes). The care manager will utilize the CBT phone app to identify a CBT interventions.
80634|NCT02081573|P1|Participant Flow|Brief CBT|During the course of the twice/month diabetes management phone sessions, over 3-4 months, the nurse care manager will work collaboratively with the patient to identify a dysfunctional belief that may be affecting adherence and could be improved by a brief CBT intervention (5-7 minutes). The care manager will utilize the CBT phone app to identify a CBT interventions.
80635|NCT02081573|O1|Outcome|Brief CBT|During the course of the twice/month diabetes management phone sessions, over 3-4 months, the nurse care manager will work collaboratively with the patient to identify a dysfunctional belief that may be affecting adherence and could be improved by a brief CBT intervention (5-7 minutes). The care manager will utilize the CBT phone app to identify a CBT interventions.
80636|NCT02081573|O1|Outcome|Brief CBT|During the course of the twice/month diabetes management phone sessions, over 3-4 months, the nurse care manager will work collaboratively with the patient to identify a dysfunctional belief that may be affecting adherence and could be improved by a brief CBT intervention (5-7 minutes). The care manager will utilize the CBT phone app to identify a CBT interventions.
80637|NCT02081573|O1|Outcome|Brief CBT|During the course of the twice/month diabetes management phone sessions, over 3-4 months, the nurse care manager will work collaboratively with the patient to identify a dysfunctional belief that may be affecting adherence and could be improved by a brief CBT intervention (5-7 minutes). The care manager will utilize the CBT phone app to identify a CBT interventions.
80638|NCT02081573|O1|Outcome|Brief CBT|During the course of the twice/month diabetes management phone sessions, over 3-4 months, the nurse care manager will work collaboratively with the patient to identify a dysfunctional belief that may be affecting adherence and could be improved by a brief CBT intervention (5-7 minutes). The care manager will utilize the CBT phone app to identify a CBT interventions.
80639|NCT02081573|O1|Outcome|Brief CBT|During the course of the twice/month diabetes management phone sessions, over 3-4 months, the nurse care manager will work collaboratively with the patient to identify a dysfunctional belief that may be affecting adherence and could be improved by a brief CBT intervention (5-7 minutes). The care manager will utilize the CBT phone app to identify a CBT interventions.
80640|NCT02081573|O1|Outcome|Brief CBT|During the course of the twice/month diabetes management phone sessions, over 3-4 months, the nurse care manager will work collaboratively with the patient to identify a dysfunctional belief that may be affecting adherence and could be improved by a brief CBT intervention (5-7 minutes). The care manager will utilize the CBT phone app to identify a CBT interventions.
80641|NCT02081573|E1|Reported Event|Brief CBT|During the course of the twice/month diabetes management phone sessions, over 3-4 months, the nurse care manager will work collaboratively with the patient to identify a dysfunctional belief that may be affecting adherence and could be improved by a brief CBT intervention (5-7 minutes). The care manager will utilize the CBT phone app to identify a CBT interventions.
80642|NCT02081443|B3|Baseline|Total|Total of all reporting groups
80643|NCT02081443|B2|Baseline|Ticagrelor 90mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
80644|NCT02081443|B1|Baseline|Ticagrelor 180mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
80647|NCT02081443|O2|Outcome|Ticagrelor 90mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
80648|NCT02081443|O1|Outcome|Ticagrelor 180mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
80649|NCT02081443|O2|Outcome|Ticagrelor 90mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
80650|NCT02081443|O1|Outcome|Ticagrelor 180mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
80651|NCT02081443|O2|Outcome|Ticagrelor 90mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
80652|NCT02081443|O1|Outcome|Ticagrelor 180mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
80653|NCT02081443|E2|Reported Event|Ticagrelor 90mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
80654|NCT02081443|E1|Reported Event|Ticagrelor 180mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
80655|NCT02081365|B3|Baseline|Total|Total of all reporting groups
80656|NCT02081365|B2|Baseline|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
80657|NCT02081365|B1|Baseline|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).~The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
80658|NCT02081365|P2|Participant Flow|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
80659|NCT02081365|P1|Participant Flow|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).~The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
80660|NCT02081365|O2|Outcome|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
80661|NCT02081365|O1|Outcome|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).~The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
80662|NCT02081365|O2|Outcome|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
80691|NCT02081079|P1|Participant Flow|Genotype 4|Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally once daily for up to 12 weeks in participants with genotype 4 hepatitis C virus (HCV) infection
80778|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80663|NCT02081365|O1|Outcome|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).~The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
80664|NCT02081365|O2|Outcome|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
80665|NCT02081365|O1|Outcome|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).~The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
80666|NCT02081365|O2|Outcome|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
80667|NCT02081365|O1|Outcome|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).~The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
80668|NCT02081365|E2|Reported Event|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
80669|NCT02081365|E1|Reported Event|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).~The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
80670|NCT02081183|B3|Baseline|Total|Total of all reporting groups
80671|NCT02081183|B2|Baseline|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
80672|NCT02081183|B1|Baseline|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, twice daily (BID) for 2 weeks; 500 mg, PO, three times daily (TID) for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
80673|NCT02081183|P2|Participant Flow|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
80674|NCT02081183|P1|Participant Flow|Mycophenolate Mofetil (MMF), Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 to (-) 1 grams per square meter (g/m^2), intravenously (IV) once per month. Participants also received prednisone, 1 milligram per kilogram per day (mg/kg/day), tablets (or methylprednisolone IV), orally (PO); the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, twice daily (BID) for 2 weeks; 500 mg, PO, three times daily (TID) for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
80692|NCT02081079|O4|Outcome|Genotype 5: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection
80779|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80675|NCT02081183|O2|Outcome|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
80676|NCT02081183|O1|Outcome|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, BID for 2 weeks; 500 mg, PO, TID for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
80677|NCT02081183|O2|Outcome|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
80678|NCT02081183|O1|Outcome|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, BID for 2 weeks; 500 mg, PO, TID for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
80679|NCT02081183|O2|Outcome|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
80680|NCT02081183|O1|Outcome|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, BID for 2 weeks; 500 mg, PO, TID for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
80681|NCT02081183|O2|Outcome|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
80682|NCT02081183|O1|Outcome|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, BID for 2 weeks; 500 mg, PO, TID for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
80683|NCT02081183|E2|Reported Event|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
80684|NCT02081183|E1|Reported Event|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, BID for 2 weeks; 500 mg, PO, TID for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
80685|NCT02081079|B5|Baseline|Total|Total of all reporting groups
80686|NCT02081079|B4|Baseline|Genotype 5: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection
80687|NCT02081079|B3|Baseline|Genotype 5: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection
80688|NCT02081079|B2|Baseline|Genotype 4: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection
80689|NCT02081079|B1|Baseline|Genotype 4: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection
80690|NCT02081079|P2|Participant Flow|Genotype 5|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 5 HCV infection
80693|NCT02081079|O3|Outcome|Genotype 5: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection
80694|NCT02081079|O2|Outcome|Genotype 4: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection
80695|NCT02081079|O1|Outcome|Genotype 4: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection
80696|NCT02081079|O4|Outcome|Genotype 5: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection
80697|NCT02081079|O3|Outcome|Genotype 5: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection
80698|NCT02081079|O2|Outcome|Genotype 4: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection
80699|NCT02081079|O1|Outcome|Genotype 4: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection
80700|NCT02081079|O4|Outcome|Genotype 5: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection
80701|NCT02081079|O3|Outcome|Genotype 5: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection
80702|NCT02081079|O2|Outcome|Genotype 4: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection
80703|NCT02081079|O1|Outcome|Genotype 4: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection
80704|NCT02081079|O2|Outcome|Genotype 5|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 5 HCV infection
80705|NCT02081079|O1|Outcome|Genotype 4|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 4 HCV infection
80706|NCT02081079|O4|Outcome|Genotype 5: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection
80707|NCT02081079|O3|Outcome|Genotype 5: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection
80708|NCT02081079|O2|Outcome|Genotype 4: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection
80709|NCT02081079|O1|Outcome|Genotype 4: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection
80710|NCT02081079|E2|Reported Event|Genotype 5|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 5 HCV infection
80711|NCT02081079|E1|Reported Event|Genotype 4|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 4 HCV infection
80712|NCT02081014|B1|Baseline|Total Study Group|Includes all 12 treated subjects
80713|NCT02081014|P6|Participant Flow|G-Pen Mini™ Dose Order: 300, 150 & 75 Micrograms|G-Pen Mini™ (glucagon injection): two 300 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 150 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 75 ug SC injections at treatment visit 3.
80714|NCT02081014|P5|Participant Flow|G-Pen Mini™ Dose Order: 300, 75 & 150 Micrograms|G-Pen Mini™ (glucagon injection): two 300 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 75 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 150 ug SC injections at treatment visit 3.
80715|NCT02081014|P4|Participant Flow|G-Pen Mini™ Dose Order: 150, 300 & 75 Micrograms|G-Pen Mini™ (glucagon injection): two 150 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 300 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 150 ug SC injections at treatment visit 3.
80716|NCT02081014|P3|Participant Flow|G-Pen Mini™ Dose Order: 150, 75 & 300 Micrograms|G-Pen Mini™ (glucagon injection): two 150 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 75 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 300 ug SC injections at treatment visit 3.
80717|NCT02081014|P2|Participant Flow|G-Pen Mini™ Dose Order: 75, 300 & 150 Micrograms|G-Pen Mini™ (glucagon injection): two 75 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 300 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 150 ug SC injections at treatment visit 3.
80718|NCT02081014|P1|Participant Flow|G-Pen Mini™ Dose Order: 75, 150 & 300 Micrograms|G-Pen Mini™ (glucagon injection): two 75 microgram (ug) subcutaneous (SC) injections at treatment visit 1, followed by a 2-21 day washout, then two 150 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 300 ug SC injections at treatment visit 3.
80719|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
80720|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
80721|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
80722|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given fo subjects following an overnight fast
80723|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given fo subjects following an overnight fast
80777|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80724|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given fo subjects following an overnight fast
80725|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
80726|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
80727|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
80728|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given given to subjects after an overnight fast
80729|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given given to subjects after an overnight fast
80730|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects after an overnight fast
80731|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
80732|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
80733|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
80734|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given given to subjects after an overnight fast
80735|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given given to subjects after an overnight fast
80736|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects after an overnight fast
80737|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
80738|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
80739|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
80740|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given fo subjects following an overnight fast
80741|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given fo subjects following an overnight fast
80742|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given fo subjects following an overnight fast
80743|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
80744|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
80745|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
80746|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given given to subjects after an overnight fast
80747|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given given to subjects after an overnight fast
80748|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects after an overnight fast
80749|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
80750|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
80751|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
80752|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given given to subjects after an overnight fast
80753|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given given to subjects after an overnight fast
80754|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects after an overnight fast
80755|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
80756|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
80757|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart
80758|NCT02081014|E3|Reported Event|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
80759|NCT02081014|E2|Reported Event|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
80760|NCT02081014|E1|Reported Event|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart
80761|NCT02081001|B3|Baseline|Total|Total of all reporting groups
80762|NCT02081001|B2|Baseline|GlucaGen First, Followed by Xeris G-Pump|Subjects who received GlucaGen at the first treatment visit and G-Pump (glucagon infusion) at the second treatment visit.
80763|NCT02081001|B1|Baseline|Xeris G-Pump Glucagon First, Followed by GlucaGen|Subjects who received G-Pump (glucagon infusion) at the first treatment visit and GlucaGen at the second treatment visit.
80764|NCT02081001|P12|Participant Flow|Dose Order: 2, 1.2 & 0.3 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 1.2 and 0.3 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
80765|NCT02081001|P11|Participant Flow|Dose Order: 2, 1.2 & 0.3 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 1.2 and 0.3 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
80766|NCT02081001|P10|Participant Flow|Dose Order: 2, 0.3 & 1.2 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 0.3 and 1.2 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
80767|NCT02081001|P9|Participant Flow|Dose Order: 2, 0.3 & 1.2 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 0.3 and 1.2 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
80768|NCT02081001|P8|Participant Flow|Dose Order: 1.2, 2 & 0.3 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 2 and 0.3 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
80769|NCT02081001|P7|Participant Flow|Dose Order: 1.2, 2 & 0.3 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 2 and 0.3 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
80770|NCT02081001|P6|Participant Flow|Dose Order: 1.2, 0.3 & 2 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 0.3 and 2.0 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
80771|NCT02081001|P5|Participant Flow|Dose Order: 1.2, 0.3 & 2 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 0.3 and 2.0 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
80772|NCT02081001|P4|Participant Flow|Dose Order: 0.3, 2 & 1.2 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 2.0 and 1.2 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
80773|NCT02081001|P3|Participant Flow|Dose Order: 0.3, 2 & 1.2 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 2.0 and 1.2 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
80774|NCT02081001|P2|Participant Flow|Dose Order: 0.3, 1.2 & 2 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 1.2 and 2.0 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
80775|NCT02081001|P1|Participant Flow|Dose Order: 0.3, 1.2 & 2 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 1.2 and 2.0 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
80776|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80780|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80781|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80782|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80783|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80784|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80785|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80786|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80787|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80788|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80789|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80790|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80791|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80792|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80793|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80794|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80795|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80796|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80797|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80798|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80799|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80800|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80801|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80802|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80803|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80804|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80805|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80806|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80807|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80808|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80809|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80810|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80811|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80812|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80813|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80814|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80815|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80816|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80817|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80818|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80819|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80820|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80821|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80822|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80823|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80824|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80825|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80826|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80827|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80828|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80829|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80830|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80831|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80832|NCT02081001|O4|Outcome|0.3μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
80833|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80834|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80835|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
80836|NCT02081001|E2|Reported Event|Novo Nordisk GlucaGen®|Novo Nordisk GlucaGen®; single subcutaneous doses of 0.3 μg/kg, 1.2 μg/kg, and 2.0 μg/kg delivered by infusion pump
80837|NCT02081001|E1|Reported Event|G-Pump™ (Glucagon Infusion)|G-Pump™ (glucagon infusion); single subcutaneous doses of 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg delivered via infusion pump
80838|NCT02080832|B4|Baseline|Total|Total of all reporting groups
80839|NCT02080832|B3|Baseline|Medication Citalopram 40mg|Citalopram (40mg dose) 40mg daily for 8 weeks
80840|NCT02080832|B2|Baseline|Placebo|Placebo: Placebo daily for 8 weeks
80841|NCT02080832|B1|Baseline|Medication Citalopram 20mg|"Citalopram (20mg dose)~Citalopram: 20 mg daily for 8 weeks"
80842|NCT02080832|P3|Participant Flow|Medication Citalopram (40mg Dose)|Citalopram (40mg dose) 40mg daily for 8 weeks
80843|NCT02080832|P2|Participant Flow|Placebo|Placebo: Placebo daily for 8 weeks
80844|NCT02080832|P1|Participant Flow|Medication Citalopram (20mg Dose)|"Citalopram (20mg dose)~Citalopram: 20 mg daily for 8 weeks"
80845|NCT02080832|O2|Outcome|Placebo|
80846|NCT02080832|O1|Outcome|Citalopram (20mg or 40mg)|Participants treated with citalopram, either 20mg or 40mg
80847|NCT02080832|O2|Outcome|Placebo|
80848|NCT02080832|O1|Outcome|Citalopram (20mg or 40mg)|Participants treated with citalopram, either 20mg or 40mg
80849|NCT02080832|O2|Outcome|Placebo|
80850|NCT02080832|O1|Outcome|Citalopram (20mg or 40mg)|Participants treated with citalopram, either 20mg or 40mg
80851|NCT02080832|O3|Outcome|Medication (Citalopram 40mg)|"Citalopram 40mg dose~Citalopram: 20 mg or 40 mg daily for 8 weeks"
80852|NCT02080832|O2|Outcome|Placebo|Placebo: Placebo daily for 8 weeks
80853|NCT02080832|O1|Outcome|Medication (Citalopram 20mg)|"Citalopram (20mg dose)~Citalopram: 20 mg or 40 mg daily for 8 weeks"
80854|NCT02080832|E3|Reported Event|Medication (Citalopram 40mg)|"Citalopram 40mg dose~Citalopram: 20 mg or 40 mg daily for 8 weeks"
80855|NCT02080832|E2|Reported Event|Placebo|Placebo: Placebo daily for 8 weeks
80856|NCT02080832|E1|Reported Event|Medication (Citalopram 20mg)|"Citalopram (20mg dose)~Citalopram: 20 mg or 40 mg daily for 8 weeks"
80857|NCT02080819|B4|Baseline|Total|Total of all reporting groups
80858|NCT02080819|B3|Baseline|Medication|"Levodopa/carbidopa 400/100 BID for 7 weeks~levodopa/carbidopa 400/100 BID: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.~Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance."
80859|NCT02080819|B2|Baseline|Placebo|"Placebo BID for 7 weeks~levodopa/carbidopa 400/100 BID: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.~Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance."
80860|NCT02080819|B1|Baseline|Healthy Control|Non drug using healthy controls
80861|NCT02080819|P3|Participant Flow|Medication|"Levodopa/carbidopa 400/100 BID for 7 weeks~levodopa/carbidopa 400/100 BID: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.~Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance."
80862|NCT02080819|P2|Participant Flow|Placebo|"Placebo BID for 7 weeks~levodopa/carbidopa 400/100 BID: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.~Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance."
80863|NCT02080819|P1|Participant Flow|Healthy Control|Non drug using healthy controls
80864|NCT02080819|O3|Outcome|Medication|"Levodopa/carbidopa 400/100 BID for 7 weeks~levodopa/carbidopa 400/100 BID: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.~Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance."
80865|NCT02080819|O2|Outcome|Placebo|"Placebo BID for 7 weeks~levodopa/carbidopa 400/100 BID: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.~Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance."
80866|NCT02080819|O1|Outcome|Healthy Control|Non drug using healthy controls
80867|NCT02080819|E3|Reported Event|Medication|"Levodopa/carbidopa 400/100 BID for 7 weeks~levodopa/carbidopa 400/100 BID: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.~Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance."
80868|NCT02080819|E2|Reported Event|Placebo|"Placebo BID for 7 weeks~levodopa/carbidopa 400/100 BID: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.~Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance."
80869|NCT02080819|E1|Reported Event|Healthy Control|Non drug using healthy controls
80870|NCT02080780|B1|Baseline|2% Diltiazem & Clarithromycin XL|"3 parts:~- Diltiazem Single Dose~- Clarithromycin XL (Days 4-9)~- Diltiazem Single Dose after Clarithromycin~Clarithromycin XL: Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg~2% Diltiazem: 2% Diltiazem Hydrochloride Cream applied on Day 1 & Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg)"
80871|NCT02080780|P1|Participant Flow|2% Diltiazem & Clarithromycin XL|"3 parts:~- Diltiazem Single Dose~- Clarithromycin XL (Days 4-9)~- Diltiazem Single Dose after Clarithromycin~Clarithromycin XL: Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg~2% Diltiazem: 2% Diltiazem Hydrochloride Cream applied on Day 1 & Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg)"
80872|NCT02080780|O2|Outcome|Diltiazem Single Dose After Clarithromycin|2% Diltiazem Hydrochloride Cream applied on Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg) following Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg
80873|NCT02080780|O1|Outcome|Diltiazem Single Dose|On the morning of Day 1, subjects received a single dose of DTZ 2% cream (~2.5 cm [1 inch] strip of cream containing approximately 8.5 mg DTZ) applied perianally. area (~2.5 cm [1 inch]; ~8.5 mg)
80874|NCT02080780|E3|Reported Event|Diltiazem Single Dose After Clarithromycin|2% Diltiazem Hydrochloride Cream applied on Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg) following Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg
80875|NCT02080780|E2|Reported Event|Clarithromycin XL (Days 4-9)|On Days 4 through 9, subjects received once daily doses of clarithromycin XL (2 tablets, 500 mg/tablet, total dose = 1000 mg/day; 6000 mg total in 6 days) with 24 hours between doses.
80876|NCT02080780|E1|Reported Event|Diltiazem Single Dose|On the morning of Day 1, subjects received a single dose of DTZ 2% cream (~2.5 cm [1 inch] strip of cream containing approximately 8.5 mg DTZ) applied perianally. area (~2.5 cm [1 inch]; ~8.5 mg)
80877|NCT02080546|B3|Baseline|Total|Total of all reporting groups
80878|NCT02080546|B2|Baseline|V-mode|"V-mode: Incision using electrothermal cautery in the V mode. The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
80879|NCT02080546|B1|Baseline|Cut/Coag|"Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the cut (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the coag (pulsed high-voltage, low-current) mode.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
80880|NCT02080546|P2|Participant Flow|V-mode|"V-mode: Incision using electrothermal cautery in the V mode. The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
80881|NCT02080546|P1|Participant Flow|Cut/Coag|"Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the cut (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the coag (pulsed high-voltage, low-current) mode.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
80882|NCT02080546|O2|Outcome|V-mode|"V-mode: Incision using electrothermal cautery in the V mode. The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
80883|NCT02080546|O1|Outcome|Cut/Coag|"Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the cut (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the coag (pulsed high-voltage, low-current) mode.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
80884|NCT02080546|O2|Outcome|V-mode|"V-mode: Incision using electrothermal cautery in the V mode. The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
80885|NCT02080546|O1|Outcome|Cut/Coag|"Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the cut (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the coag (pulsed high-voltage, low-current) mode.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
80886|NCT02080546|E2|Reported Event|V-mode|"V-mode: Incision using electrothermal cautery in the V mode. The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
80887|NCT02080546|E1|Reported Event|Cut/Coag|"Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the cut (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the coag (pulsed high-voltage, low-current) mode.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
80888|NCT02080507|B3|Baseline|Total|Total of all reporting groups
80889|NCT02080507|B2|Baseline|Inactive Neuronetics rTMS Stimulator|Participants in this group were randomized to receive sham repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
80890|NCT02080507|B1|Baseline|Active Neuronetics rTMS Stimulator|Participants in this group were randomized to receive active repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
80891|NCT02080507|P2|Participant Flow|Inactive Neuronetics rTMS Stimulator|Participants in this group were randomized to receive sham repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
80892|NCT02080507|P1|Participant Flow|Active Neuronetics rTMS Stimulator|Participants in this group were randomized to receive active repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
80893|NCT02080507|O2|Outcome|Inactive Neuronetics rTMS Stimulator|Participants in this group were randomized to receive sham repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
80894|NCT02080507|O1|Outcome|Active Neuronetics rTMS Stimulator|Participants in this group were randomized to receive active repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
80895|NCT02080507|O2|Outcome|Inactive Neuronetics rTMS Stimulator|Participants in this group were randomized to receive sham repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
80896|NCT02080507|O1|Outcome|Active Neuronetics rTMS Stimulator|Participants in this group were randomized to receive active repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
80897|NCT02080507|E2|Reported Event|Inactive Neuronetics rTMS Stimulator|Participants in this group were randomized to receive sham repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
80898|NCT02080507|E1|Reported Event|Active Neuronetics rTMS Stimulator|Participants in this group were randomized to receive active repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
80899|NCT02080481|B3|Baseline|Total|Total of all reporting groups
80900|NCT02080481|B2|Baseline|Conventional Block Needle|"ultrasound guidance with a conventional block needle~Conventional block needle: conventional block needle used for insertion of femoral nerve catheters."
80901|NCT02080481|B1|Baseline|Infiniti Plus Needle Guidance System|"ultrasound guidance with the InfinitiPlus (TM) needle guidance system~Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks."
80902|NCT02080481|P2|Participant Flow|Conventional Block Needle|"ultrasound guidance with a conventional block needle~Conventional block needle: conventional block needle used for insertion of femoral nerve catheters."
80903|NCT02080481|P1|Participant Flow|Infiniti Plus Needle Guidance System|"ultrasound guidance with the InfinitiPlus (TM) needle guidance system~Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks."
80904|NCT02080481|O2|Outcome|Conventional Block Needle|"ultrasound guidance with a conventional block needle~Conventional block needle: conventional block needle used for insertion of femoral nerve catheters."
80905|NCT02080481|O1|Outcome|Infiniti Plus Needle Guidance System|"ultrasound guidance with the InfinitiPlus (TM) needle guidance system~Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks."
80906|NCT02080481|O2|Outcome|Conventional Block Needle|"ultrasound guidance with a conventional block needle~Conventional block needle: conventional block needle used for insertion of femoral nerve catheters."
80907|NCT02080481|O1|Outcome|Infiniti Plus Needle Guidance System|"ultrasound guidance with the InfinitiPlus (TM) needle guidance system~Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks."
80908|NCT02080481|O2|Outcome|Conventional Block Needle|"ultrasound guidance with a conventional block needle~Conventional block needle: conventional block needle used for insertion of femoral nerve catheters."
80909|NCT02080481|O1|Outcome|Infiniti Plus Needle Guidance System|"ultrasound guidance with the InfinitiPlus (TM) needle guidance system~Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks."
80910|NCT02080481|O2|Outcome|Conventional Block Needle|"ultrasound guidance with a conventional block needle~Conventional block needle: conventional block needle used for insertion of femoral nerve catheters."
80911|NCT02080481|O1|Outcome|Infiniti Plus Needle Guidance System|"ultrasound guidance with the InfinitiPlus (TM) needle guidance system~Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks."
80912|NCT02080481|E2|Reported Event|Conventional Block Needle|"ultrasound guidance with a conventional block needle~Conventional block needle: conventional block needle used for insertion of femoral nerve catheters."
80913|NCT02080481|E1|Reported Event|Infiniti Plus Needle Guidance System|"ultrasound guidance with the InfinitiPlus (TM) needle guidance system~Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks."
80914|NCT02080312|B1|Baseline|Intratympanic Injection|"Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.~Magnevist (gadopentetate dimeglumine)"
80915|NCT02080312|P1|Participant Flow|Intratympanic Injection|"Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.~Magnevist (gadopentetate dimeglumine)"
80916|NCT02080312|O1|Outcome|Intratympanic Injection|Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.
80917|NCT02080312|O1|Outcome|Intratympanic Injection|Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.
81139|NCT02077374|E1|Reported Event|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
80918|NCT02080312|O1|Outcome|Intratympanic Injection|"Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.~Magnevist (gadopentetate dimeglumine)"
80919|NCT02080312|E1|Reported Event|Intratympanic Injection|"Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.~Magnevist (gadopentetate dimeglumine)"
80920|NCT02080091|B1|Baseline|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
80921|NCT02080091|P1|Participant Flow|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
80922|NCT02080091|O1|Outcome|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
80923|NCT02080091|O1|Outcome|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
80924|NCT02080091|O1|Outcome|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
80925|NCT02080091|E1|Reported Event|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
80926|NCT02079844|B4|Baseline|Total|Total of all reporting groups
80927|NCT02079844|B3|Baseline|Roflumilast 250 μg + Placebo + Roflumilast 100 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80928|NCT02079844|B2|Baseline|Roflumilast 100 μg + Roflumilast 250 μg + Placebo|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80929|NCT02079844|B1|Baseline|Placebo + Roflumilast 100 μg + Roflumilast 250 μg|Roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80930|NCT02079844|P3|Participant Flow|Roflumilast 250 μg + Placebo + Roflumilast 100 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80931|NCT02079844|P2|Participant Flow|Roflumilast 100 μg + Roflumilast 250 μg + Placebo|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80932|NCT02079844|P1|Participant Flow|Placebo + Roflumilast 100 μg + Roflumilast 250 μg|Roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80933|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80934|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80935|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80936|NCT02079844|O3|Outcome|Roflumilast 250 μg + Placebo + Roflumilast 100 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80937|NCT02079844|O2|Outcome|Roflumilast 100 μg + Roflumilast 250 μg + Placebo|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80938|NCT02079844|O1|Outcome|Placebo + Roflumilast 100 μg + Roflumilast 250 μg|Roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
81140|NCT02077140|B6|Baseline|Total|Total of all reporting groups
80939|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80940|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80941|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80942|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80943|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80944|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80945|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80946|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80947|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80948|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80949|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80950|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80951|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80952|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80953|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80954|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80955|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80956|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80957|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80958|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80959|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80960|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80961|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80962|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80963|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80964|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80965|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80966|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80967|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80968|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80969|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80970|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80971|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80972|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80973|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80974|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80975|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80976|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80977|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80978|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80979|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80980|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80981|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80982|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80983|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80984|NCT02079844|E3|Reported Event|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80985|NCT02079844|E2|Reported Event|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80986|NCT02079844|E1|Reported Event|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
80987|NCT02079805|B3|Baseline|Total|Total of all reporting groups
80988|NCT02079805|B2|Baseline|Azilsartan 20 mg|Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
80989|NCT02079805|B1|Baseline|Telmisartan 40 mg|Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
80990|NCT02079805|P2|Participant Flow|Azilsartan 20 mg|Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
80991|NCT02079805|P1|Participant Flow|Telmisartan 40 mg|Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
80992|NCT02079805|O2|Outcome|Azilsartan 20 mg|Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
80993|NCT02079805|O1|Outcome|Telmisartan 40 mg|Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
80994|NCT02079805|O2|Outcome|Azilsartan 20 mg|Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
80995|NCT02079805|O1|Outcome|Telmisartan 40 mg|Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
80996|NCT02079805|O2|Outcome|Azilsartan 20 mg|Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
80997|NCT02079805|O1|Outcome|Telmisartan 40 mg|Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
80998|NCT02079805|O2|Outcome|Azilsartan 20 mg|Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
80999|NCT02079805|O1|Outcome|Telmisartan 40 mg|Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
81000|NCT02079805|O2|Outcome|Azilsartan 20 mg|Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
81001|NCT02079805|O1|Outcome|Telmisartan 40 mg|Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
81002|NCT02079805|O2|Outcome|Azilsartan 20 mg|Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
82793|NCT02068027|O2|Outcome|Placebo|"Placebo gel of identical appearance as active treatment~Placebo"
81003|NCT02079805|O1|Outcome|Telmisartan 40 mg|Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
81004|NCT02079805|O2|Outcome|Azilsartan 20 mg|Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
81005|NCT02079805|O1|Outcome|Telmisartan 40 mg|Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
81006|NCT02079805|E2|Reported Event|Azilsartan 20 mg|Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
81007|NCT02079805|E1|Reported Event|Telmisartan 40 mg|Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
81008|NCT02079649|B5|Baseline|Total|Total of all reporting groups
81009|NCT02079649|B4|Baseline|Vehicle|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
81010|NCT02079649|B3|Baseline|Maxidex|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
81011|NCT02079649|B2|Baseline|AL-53817|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
81012|NCT02079649|B1|Baseline|AL-78843|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
81013|NCT02079649|P4|Participant Flow|Vehicle|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
81014|NCT02079649|P3|Participant Flow|Maxidex|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
81015|NCT02079649|P2|Participant Flow|AL-53817|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
81016|NCT02079649|P1|Participant Flow|AL-78843|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
81017|NCT02079649|O4|Outcome|Vehicle|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
81018|NCT02079649|O3|Outcome|Maxidex|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
81019|NCT02079649|O2|Outcome|AL-53817|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
81020|NCT02079649|O1|Outcome|AL-78843|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
81021|NCT02079649|O4|Outcome|Vehicle|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
81022|NCT02079649|O3|Outcome|Maxidex|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
81023|NCT02079649|O2|Outcome|AL-53817|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
81024|NCT02079649|O1|Outcome|AL-78843|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
81025|NCT02079649|E5|Reported Event|Vehicle|Includes all subjects who were randomized to and treated with investigational product
81026|NCT02079649|E4|Reported Event|Maxidex|Includes all subjects who were randomized to and treated with investigational product
81027|NCT02079649|E3|Reported Event|AL-53817|Includes all subjects who were randomized to and treated with investigational product
81028|NCT02079649|E2|Reported Event|AL-78843|Includes all subjects who were randomized to and treated with investigational product
81029|NCT02079649|E1|Reported Event|Pre-Treatment|Includes all subjects who consented to participate in the study
81030|NCT02079610|B3|Baseline|Total|Total of all reporting groups
81031|NCT02079610|B2|Baseline|Real-time fMRI Neurofeedback: HIPS|"HIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart.~real-time fMRI neurofeedback: HIPS: Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories."
81032|NCT02079610|B1|Baseline|Real-time fMRI Neurofeedback: Amygdala|"Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart.~real-time fMRI neurofeedback: Amygdala: Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories."
81033|NCT02079610|P2|Participant Flow|Real-time fMRI Neurofeedback: HIPS|"HIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart.~real-time fMRI neurofeedback: HIPS: Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories."
81034|NCT02079610|P1|Participant Flow|Real-time fMRI Neurofeedback: Amygdala|"Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart.~real-time fMRI neurofeedback: Amygdala: Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories."
81050|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
81141|NCT02077140|B5|Baseline|Control (In Cohort 1 to 4)|Control subjects in Cohort 1 to 4 received standard of care for pain control.
81035|NCT02079610|O2|Outcome|Real-time fMRI Neurofeedback: HIPS|"HIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart.~real-time fMRI neurofeedback: HIPS: Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories."
81036|NCT02079610|O1|Outcome|Real-time fMRI Neurofeedback: Amygdala|"Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart.~real-time fMRI neurofeedback: Amygdala: Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories."
81037|NCT02079610|O2|Outcome|Real-time fMRI Neurofeedback: HIPS|"HIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart.~real-time fMRI neurofeedback: HIPS: Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories."
81038|NCT02079610|O1|Outcome|Real-time fMRI Neurofeedback: Amygdala|"Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart.~real-time fMRI neurofeedback: Amygdala: Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories."
81039|NCT02079610|O2|Outcome|Real-time fMRI Neurofeedback: HIPS|"HIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart.~real-time fMRI neurofeedback: HIPS: Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories."
81040|NCT02079610|O1|Outcome|Real-time fMRI Neurofeedback: Amygdala|"Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart.~real-time fMRI neurofeedback: Amygdala: Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories."
81041|NCT02079610|E2|Reported Event|Real-time fMRI Neurofeedback: HIPS|"HIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart.~real-time fMRI neurofeedback: HIPS: Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories."
81042|NCT02079610|E1|Reported Event|Real-time fMRI Neurofeedback: Amygdala|"Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart.~real-time fMRI neurofeedback: Amygdala: Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories."
81043|NCT02079532|B1|Baseline|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
81044|NCT02079532|P1|Participant Flow|Rituximab Plus Methotrexate (MTX)|Participants received rituximab, 1 gram (g), intravenously (IV), and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
81045|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
81046|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
81047|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
81048|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
81049|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
81072|NCT02079311|P2|Participant Flow|Forced Air Warming Device|"Active warming with forced air warming (FAW) during the intraoperative phase.~Forced air warming device: Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection."
81051|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
81052|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
81053|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
81054|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
81055|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
81056|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
81057|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
81058|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
81059|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
81060|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
81061|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
81062|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
81063|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
81064|NCT02079532|E1|Reported Event|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
81065|NCT02079519|B1|Baseline|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months.
81066|NCT02079519|P1|Participant Flow|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months.
81067|NCT02079519|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months.
81068|NCT02079519|E1|Reported Event|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months.
81069|NCT02079311|B3|Baseline|Total|Total of all reporting groups
81070|NCT02079311|B2|Baseline|Forced Air Warming Device|"Active warming with forced air warming (FAW) during the intraoperative phase.~Forced air warming device: Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection."
81071|NCT02079311|B1|Baseline|Active Self-warming Blanket|"Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase~Active self warming blanket: BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron."
81135|NCT02077374|O1|Outcome|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg Twice daily for 28 days"
81073|NCT02079311|P1|Participant Flow|Active Self-warming Blanket|"Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase~Active self warming blanket: BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron."
81074|NCT02079311|O2|Outcome|Forced Air Warming Device|"Active warming with forced air warming (FAW) during the intraoperative phase.~Forced air warming device: Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection."
81075|NCT02079311|O1|Outcome|Active Self-warming Blanket|"Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase~Active self warming blanket: BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron."
81076|NCT02079311|E2|Reported Event|Forced Air Warming Device|"Active warming with forced air warming (FAW) during the intraoperative phase.~Forced air warming device: Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection."
81077|NCT02079311|E1|Reported Event|Active Self-warming Blanket|"Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase~Active self warming blanket: BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron."
81078|NCT02078492|B4|Baseline|Total|Total of all reporting groups
81079|NCT02078492|B3|Baseline|Group 3 - 30mg|"Subject will receive 30mg of Ketorolac as a part of standard care.~30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control."
81080|NCT02078492|B2|Baseline|Group 2 - 15mg|"Subjects will be administered 15mg of Ketorolac.~15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control."
81081|NCT02078492|B1|Baseline|Group 1 - 10 mg of Ketorolac|"Subjects will be administered 10 mg of Ketorolac for pain relief.~10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control."
81082|NCT02078492|P3|Participant Flow|Group 3 - 30mg|"Subject will receive 30mg of Ketorolac as a part of standard care.~30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control."
81083|NCT02078492|P2|Participant Flow|Group 2 - 15mg|"Subjects will be administered 15mg of Ketorolac.~15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control."
81084|NCT02078492|P1|Participant Flow|Group 1 - 10 mg of Ketorolac|"Subjects will be administered 10 mg of Ketorolac for pain relief.~10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control."
81085|NCT02078492|O3|Outcome|Group 3 - 30mg|"Subject will receive 30mg of Ketorolac as a part of standard care.~30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control."
81086|NCT02078492|O2|Outcome|Group 2 - 15mg|"Subjects will be administered 15mg of Ketorolac.~15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control."
81087|NCT02078492|O1|Outcome|Group 1 - 10 mg of Ketorolac|"Subjects will be administered 10 mg of Ketorolac for pain relief.~10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control."
81088|NCT02078492|O3|Outcome|Group 3 - 30mg|"Subject will receive 30mg of Ketorolac as a part of standard care.~30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control."
81089|NCT02078492|O2|Outcome|Group 2 - 15mg|"Subjects will be administered 15mg of Ketorolac.~15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control."
81090|NCT02078492|O1|Outcome|Group 1 - 10 mg of Ketorolac|"Subjects will be administered 10 mg of Ketorolac for pain relief.~10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control."
81091|NCT02078492|O3|Outcome|Group 3 - 30mg|"Subject will receive 30mg of Ketorolac as a part of standard care.~30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control."
81092|NCT02078492|O2|Outcome|Group 2 - 15mg|"Subjects will be administered 15mg of Ketorolac.~15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control."
81093|NCT02078492|O1|Outcome|Group 1 - 10 mg of Ketorolac|"Subjects will be administered 10 mg of Ketorolac for pain relief.~10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control."
81094|NCT02078492|O3|Outcome|Group 3 - 30mg|"Subject will receive 30mg of Ketorolac as a part of standard care.~30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control."
81095|NCT02078492|O2|Outcome|Group 2 - 15mg|"Subjects will be administered 15mg of Ketorolac.~15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control."
81096|NCT02078492|O1|Outcome|Group 1 - 10 mg of Ketorolac|"Subjects will be administered 10 mg of Ketorolac for pain relief.~10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control."
81097|NCT02078492|E3|Reported Event|Group 3 - 30mg|"Subject will receive 30mg of Ketorolac as a part of standard care.~30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control."
81098|NCT02078492|E2|Reported Event|Group 2 - 15mg|"Subjects will be administered 15mg of Ketorolac.~15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control."
81099|NCT02078492|E1|Reported Event|Group 1 - 10 mg of Ketorolac|"Subjects will be administered 10 mg of Ketorolac for pain relief.~10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control."
81100|NCT02078193|B1|Baseline|Belatacept|All patients enrolled will be converted to Belatacept from prograf.
81101|NCT02078193|P1|Participant Flow|Belatacept|All patients enrolled will be converted to Belatacept from prograf.
81102|NCT02078193|O1|Outcome|Belatacept|"Participants will be converted from their current Mycophenolate Mofetil (MMF) to once a month infusions of Belatacept~Belatacept: Patients will be converted from their MMF to Belatacept"
81103|NCT02078193|O1|Outcome|Belatacept|Participants who received Belatacept by IV infusion.
81104|NCT02078193|O1|Outcome|Belatacept|"Participants will be converted from their current Mycophenolate Mofetil (MMF) to once a month infusions of Belatacept~Belatacept: Patients will be converted from their MMF to Belatacept"
81105|NCT02078193|E1|Reported Event|Belatacept|All patients enrolled will be converted to Belatacept from prograf.
81106|NCT02078180|B1|Baseline|IR 75, IR 100, SR 100, SR 150, XL 150 and XL 300|Participants were randomized to receive one pill each of IR 75, IR 100, SR 100, SR 150, XL 150 and XL 300,in randomized order at six time points. Given the large number of possible sequence combinations, participants are reported as a single Participant Flow Arm with Milestones used to indicate how many participants received each intervention
81107|NCT02078180|P1|Participant Flow|IR75, IR200, SR100, SR150, XL150, XL300|Participants were randomized to receive one pill each of IR 75, IR 100, SR 100, SR 150, XL 150 and XL 300,in randomized order at six time points. Given the large number of possible sequence combinations, participants are reported as a single Participant Flow Arm with Milestones used to indicate how many participants received each intervention
81108|NCT02078180|O6|Outcome|Generic Bupropion XL300|"One oral dose of generic bupropion XL300~generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."
81109|NCT02078180|O5|Outcome|Generic Bupropion XL150|"One oral dose of generic bupropion XL150~generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."
81110|NCT02078180|O4|Outcome|Generic Bupropion SR150|"One oral dose of generic bupropion SR150~generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."
81111|NCT02078180|O3|Outcome|Generic Bupropion SR100|"One oral dose of generic bupropion SR100~generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."
81112|NCT02078180|O2|Outcome|Generic Bupropion IR100|"One oral dose of generic bupropion IR100~generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."
81113|NCT02078180|O1|Outcome|Generic Bupropion IR75|"One oral dose of generic bupropion IR75~generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."
81114|NCT02078180|O6|Outcome|Generic Bupropion XL300|"One oral dose of generic bupropion XL300~generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."
81115|NCT02078180|O5|Outcome|Generic Bupropion XL150|"One oral dose of generic bupropion XL150~generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."
81116|NCT02078180|O4|Outcome|Generic Bupropion SR150|"One oral dose of generic bupropion SR150~generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."
81117|NCT02078180|O3|Outcome|Generic Bupropion SR100|"One oral dose of generic bupropion SR100~generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."
81118|NCT02078180|O2|Outcome|Generic Bupropion IR100|"One oral dose of generic bupropion IR100~generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."
81119|NCT02078180|O1|Outcome|Generic Bupropion IR75|"One oral dose of generic bupropion IR75~generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."
81120|NCT02078180|E1|Reported Event|IR 75, IR 100, SR 100, SR 150, XL 150 and XL 300|Participants were randomized to receive one pill each of IR 75, IR 100, SR 100, SR 150, XL 150 and XL 300,in randomized order at six time points. Given the large number of possible sequence combinations, participants are reported as a single Participant Flow Arm with Milestones used to indicate how many participants received each intervention
81121|NCT02077374|B3|Baseline|Total|Total of all reporting groups
81122|NCT02077374|B2|Baseline|Placebo|"Placebo~Matching Placebo BID for 28 days"
81123|NCT02077374|B1|Baseline|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
81124|NCT02077374|P2|Participant Flow|Placebo|"Placebo~Matching Placebo BID for 28 days"
81125|NCT02077374|P1|Participant Flow|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
81126|NCT02077374|O2|Outcome|Placebo|"Placebo~Placebo: Placebo BID for 28 Days"
81127|NCT02077374|O1|Outcome|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
81128|NCT02077374|O2|Outcome|Placebo|"Placebo~Matching Placebo BID for 28 days"
81129|NCT02077374|O1|Outcome|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
81130|NCT02077374|O2|Outcome|Placebo|"Placebo~Matching Placebo BID for 28 days"
81131|NCT02077374|O1|Outcome|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
81132|NCT02077374|O2|Outcome|Placebo|"Placebo~Matching Placebo BID for 28 days"
81133|NCT02077374|O1|Outcome|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
81134|NCT02077374|O2|Outcome|Placebo|"Placebo~Placebo: Placebo Twice daily for 28 Days"
81142|NCT02077140|B4|Baseline|2 MDT-10013 Strips (In Cohort 4)|For the investigational subjects of Cohort 4, two MDT-10013 strips were sutured to the interior capsule wall.
81143|NCT02077140|B3|Baseline|3 MDT-10013 Strips (In Cohort 3)|For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
81144|NCT02077140|B2|Baseline|2 MDT-10013 Strips (In Cohort 2)|For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
81145|NCT02077140|B1|Baseline|1 MDT-10013 Strip (In Cohort 1)|For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
81146|NCT02077140|P5|Participant Flow|Control (In Cohort 1-4)|Control subjects in Cohort 1 to 4 received standard of care (no strip) for pain control.
81147|NCT02077140|P4|Participant Flow|2 MDT-10013 Strips (In Cohort 4)|For the investigational subjects of Cohort 4, two strips were sutured to the interior capsule wall.
81148|NCT02077140|P3|Participant Flow|3 MDT-10013 Strips (In Cohort 3)|For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
81149|NCT02077140|P2|Participant Flow|2 MDT-10013 Strips (In Cohort 2)|For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
81150|NCT02077140|P1|Participant Flow|1 MDT-10013 Strip (In Cohort 1)|For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
81151|NCT02077140|O5|Outcome|Control (In Cohort 1 to 4)|Control subjects of Cohort 1 to 4 received standard of care for pain control.
81152|NCT02077140|O4|Outcome|2 MDT-10013 Strips (In Cohort 4)|For the investigational subjects of Cohort 4, two MDT-10013 strips were sutured to the interior capsule wall.
81153|NCT02077140|O3|Outcome|3 MDT-10013 Strips (In Cohort 3)|For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
81154|NCT02077140|O2|Outcome|2 MDT-10013 Strips (In Cohort 2)|For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
81155|NCT02077140|O1|Outcome|1 MDT-10013 Strip (In Cohort 1)|For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
81156|NCT02077140|O5|Outcome|Control (In Cohort 1 to 4)|Control subjects of Cohort 1 to 4 received standard of care for pain control.
81157|NCT02077140|O4|Outcome|2 MDT-10013 Strips (In Cohort 4)|For the investigational subjects of Cohort 4, two MDT-10013 strips were sutured to the interior capsule wall.
81158|NCT02077140|O3|Outcome|3 MDT-10013 Strips (In Cohort 3)|For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
81159|NCT02077140|O2|Outcome|2 MDT-10013 Strips (In Cohort 2)|For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
81160|NCT02077140|O1|Outcome|1 MDT-10013 Strip (In Cohort 1)|For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
81161|NCT02077140|O5|Outcome|Control (In Cohort 1 to 4)|Control subjects of Cohort 1 to 4 received standard of care for pain control.
81162|NCT02077140|O4|Outcome|2 MDT-10013 Strips (In Cohort 4)|For the investigational subjects of Cohort 4, two MDT-10013 strips were sutured to the interior capsule wall.
81163|NCT02077140|O3|Outcome|3 MDT-10013 Strips (In Cohort 3)|For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
81164|NCT02077140|O2|Outcome|2 MDT-10013 Strips (In Cohort 2)|For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
81165|NCT02077140|O1|Outcome|1 MDT-10013 Strip (In Cohort 1)|For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
81166|NCT02077140|O5|Outcome|Control (In Cohort 1 to 4)|Control subjects of Cohort 1 to 4 received standard of care for pain control.
81167|NCT02077140|O4|Outcome|2 MDT-10013 Strips (In Cohort 4)|For the investigational subjects of Cohort 4, two MDT-10013 strips were sutured to the interior capsule wall.
81168|NCT02077140|O3|Outcome|3 MDT-10013 Strips (In Cohort 3)|For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
81169|NCT02077140|O2|Outcome|2 MDT-10013 Strips (In Cohort 2)|For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
81170|NCT02077140|O1|Outcome|1 MDT-10013 Strip (In Cohort 1)|For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
81171|NCT02077140|O4|Outcome|2 MDT-10013 Strips (In Cohort 4)|For the investigational subjects of Cohort 4, two MDT-10013 strips were sutured to the interior capsule wall.
81172|NCT02077140|O3|Outcome|3 MDT-10013 Strips (In Cohort 3)|For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
81173|NCT02077140|O2|Outcome|2 MDT-10013 Strips (In Cohort 2)|For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
81174|NCT02077140|O1|Outcome|1 MDT-10013 Strip (In Cohort 1)|For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
81175|NCT02077140|O4|Outcome|2 MDT-10013 Strips (In Cohort 4)|For the investigational subjects of Cohort 4, two MDT-10013 strips were sutured to the interior capsule wall.
81176|NCT02077140|O3|Outcome|3 MDT-10013 Strips (In Cohort 3)|For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
81177|NCT02077140|O2|Outcome|2 MDT-10013 Strips (In Cohort 2)|For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
81178|NCT02077140|O1|Outcome|1 MDT-10013 Strip (In Cohort 1)|For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
81179|NCT02077140|O4|Outcome|2 MDT-10013 Strips (In Cohort 4)|For the investigational subjects of Cohort 4, two MDT-10013 strips were sutured to the interior capsule wall.
81180|NCT02077140|O3|Outcome|3 MDT-10013 Strips (In Cohort 3)|For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
81181|NCT02077140|O2|Outcome|2 MDT-10013 Strips (In Cohort 2)|For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
81182|NCT02077140|O1|Outcome|1 MDT-10013 Strip (In Cohort 1)|For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
81183|NCT02077140|O4|Outcome|2 MDT-10013 Strips (In Cohort 4)|For the investigational subjects of Cohort 4, two MDT-10013 strips were sutured to the interior capsule wall.
81184|NCT02077140|O3|Outcome|3 MDT-10013 Strips (In Cohort 3)|For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
81185|NCT02077140|O2|Outcome|2 MDT-10013 Strips (In Cohort 2)|For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
81186|NCT02077140|O1|Outcome|1 MDT-10013 Strip (In Cohort 1)|For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
81187|NCT02077140|O4|Outcome|2 MDT-10013 Strips (In Cohort 4)|For the investigational subjects of Cohort 4, two MDT-10013 strips were sutured to the interior capsule wall.
81188|NCT02077140|O3|Outcome|3 MDT-10013 Strips (In Cohort 3)|For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
81189|NCT02077140|O2|Outcome|2 MDT-10013 Strips (In Cohort 2)|For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
81190|NCT02077140|O1|Outcome|1 MDT-10013 Strip (In Cohort 1)|For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
81191|NCT02077140|O4|Outcome|2 MDT-10013 Strips (In Cohort 4)|For the investigational subjects of Cohort 4, two MDT-10013 strips were sutured to the interior capsule wall.
81192|NCT02077140|O3|Outcome|3 MDT-10013 Strips (In Cohort 3)|For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
81193|NCT02077140|O2|Outcome|2 MDT-10013 Strips (In Cohort 2)|For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
81194|NCT02077140|O1|Outcome|1 MDT-10013 Strip (In Cohort 1)|For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
81195|NCT02077140|O4|Outcome|2 MDT-10013 Strips (In Cohort 4)|For the investigational subjects of Cohort 4, two strips were sutured to the interior capsule wall.
81196|NCT02077140|O3|Outcome|3 MDT-10013 Strips (In Cohort 3)|For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
81197|NCT02077140|O2|Outcome|2 MDT-10013 Strips (In Cohort 2)|For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
81198|NCT02077140|O1|Outcome|1 MDT-10013 Strip (In Cohort 1)|For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
81199|NCT02077140|O4|Outcome|Control (In Cohort 1 to 3)|Control subjects in Cohort 1 to 3 received standard of care for pain control.
81200|NCT02077140|O3|Outcome|3 MDT-10013 Strips (In Cohort 3)|For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
81201|NCT02077140|O2|Outcome|2 MDT-10013 Strips (In Cohort 2)|For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
81202|NCT02077140|O1|Outcome|1 MDT-10013 Strip (In Cohort 1)|For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
81203|NCT02077140|O4|Outcome|Control (In Cohort 1 to 3)|Control subjects in Cohort 1 to 3 received standard of care for pain control.
81204|NCT02077140|O3|Outcome|3 MDT-10013 Strips (In Cohort 3)|For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
81205|NCT02077140|O2|Outcome|2 MDT-10013 Strips (In Cohort 2)|For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
81206|NCT02077140|O1|Outcome|1 MDT-10013 Strip (In Cohort 1)|For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
81207|NCT02077140|O4|Outcome|Control (In Cohort 1 to 3)|Control subjects in Cohort 1 to 3 received standard of care for pain control.
81208|NCT02077140|O3|Outcome|3 MDT-10013 Strips (In Cohort 3)|For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
81209|NCT02077140|O2|Outcome|2 MDT-10013 Strips (In Cohort 2)|For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
81210|NCT02077140|O1|Outcome|1 MDT-10013 Strip (In Cohort 1)|For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
81211|NCT02077140|O4|Outcome|Control (In Cohort 1 to 3)|Control subjects in Cohort 1 to 3 received standard of care for pain control.
81212|NCT02077140|O3|Outcome|3 MDT-10013 Strips (In Cohort 3)|For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
81256|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
81213|NCT02077140|O2|Outcome|2 MDT-10013 Strips (In Cohort 2)|For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
81214|NCT02077140|O1|Outcome|1 MDT-10013 Strip (In Cohort 1)|For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
81215|NCT02077140|O4|Outcome|Control (In Cohort 1 to 3)|Control subjects in Cohort 1 to 3 received standard of care for pain control.
81216|NCT02077140|O3|Outcome|3 MDT-10013 Strips (In Cohort 3)|For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
81217|NCT02077140|O2|Outcome|2 MDT-10013 Strips (In Cohort 2)|For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
81218|NCT02077140|O1|Outcome|1 MDT-10013 Strip (In Cohort 1)|For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
81219|NCT02077140|O4|Outcome|Control (In Cohort 1 to 3)|Control subjects in Cohort 1 to 3 received standard of care for pain control.
81220|NCT02077140|O3|Outcome|3 MDT-10013 Strips (In Cohort 3)|For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
81221|NCT02077140|O2|Outcome|2 MDT-10013 Strips (In Cohort 2)|For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
81222|NCT02077140|O1|Outcome|1 MDT-10013 Strip (In Cohort 1)|For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
81223|NCT02077140|O4|Outcome|Control (In Cohort 1 to 3)|Control subjects in Cohort 1 to 3 received standard of care for pain control.
81224|NCT02077140|O3|Outcome|3 MDT-10013 Strips (In Cohort 3)|For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
81225|NCT02077140|O2|Outcome|2 MDT-10013 Strips (In Cohort 2)|For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
81226|NCT02077140|O1|Outcome|1 MDT-10013 Strip (In Cohort 1)|For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
81227|NCT02077140|O4|Outcome|Control (In Cohort 1-3)|Control subjects in Cohort 1 to 3 received standard of care for pain control.
81228|NCT02077140|O3|Outcome|3 MDT-10013 Strips (In Cohort 3)|For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
81229|NCT02077140|O2|Outcome|2 MDT-10013 Strips (In Cohort 2)|For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
81230|NCT02077140|O1|Outcome|1 MDT-10013 Strip (In Cohort 1)|For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
81231|NCT02077140|E5|Reported Event|Control (In Cohort 1 to 4)|Control subjects in Cohort 1 to 4 received standard of care (no strip) for pain control.
81232|NCT02077140|E4|Reported Event|2 MDT-10013 Strips (In Cohort 4)|For the investigational subjects of Cohort 4, two strips were sutured to the interior capsule wall.
81233|NCT02077140|E3|Reported Event|3 MDT-10013 Strips (In Cohort 3)|For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
81234|NCT02077140|E2|Reported Event|2 MDT-10013 Strips (In Cohort 2)|For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
81235|NCT02077140|E1|Reported Event|1 MDT-10013 Strip (In Cohort 1)|For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
81236|NCT02076919|B13|Baseline|Total|Total of all reporting groups
81237|NCT02076919|B12|Baseline|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
81238|NCT02076919|B11|Baseline|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
81239|NCT02076919|B10|Baseline|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
81240|NCT02076919|B9|Baseline|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
81241|NCT02076919|B8|Baseline|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
81242|NCT02076919|B7|Baseline|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
81243|NCT02076919|B6|Baseline|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
81244|NCT02076919|B5|Baseline|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
81245|NCT02076919|B4|Baseline|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
81246|NCT02076919|B3|Baseline|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
81247|NCT02076919|B2|Baseline|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
81248|NCT02076919|B1|Baseline|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
81249|NCT02076919|P4|Participant Flow|Vehicle, Part 2|Inactive ingredients, 1 drop instilled in the study eye once, twice, or 3 times daily for 7 days during Part 2
81250|NCT02076919|P3|Participant Flow|LHA510, Part 2|Ophthalmic suspension in 1 of 4 concentrations, 1 drop instilled in the study eye once, twice, or three times daily for 7 days during Part 2
81251|NCT02076919|P2|Participant Flow|Vehicle, Part 1|Inactive ingredients, 1 drop instilled in the study eye as a single dose during Part 1
81252|NCT02076919|P1|Participant Flow|LHA510, Part 1|Ophthalmic suspension in 1 of 4 concentrations, 1 drop instilled in the study eye as a single dose during Part 1
81253|NCT02076919|O7|Outcome|Vehicle, Part 2|One drop instilled in the study eye once, twice, or three times daily for 7 days
81254|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
81255|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
81257|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
81258|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
81259|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
81260|NCT02076919|O7|Outcome|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
81261|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
81262|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
81263|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
81264|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
81265|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
81266|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
81267|NCT02076919|O7|Outcome|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
81268|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
81269|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
81270|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
81271|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
81272|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
81273|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
81274|NCT02076919|O5|Outcome|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
81275|NCT02076919|O4|Outcome|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
81276|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
81277|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
81278|NCT02076919|O1|Outcome|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
81279|NCT02076919|O5|Outcome|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
81280|NCT02076919|O4|Outcome|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
81281|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
81282|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
81283|NCT02076919|O1|Outcome|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
81284|NCT02076919|O7|Outcome|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
81285|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
81286|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
81287|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
81288|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
81289|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
81290|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
81291|NCT02076919|O5|Outcome|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
81292|NCT02076919|O4|Outcome|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
81293|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
81294|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
81295|NCT02076919|O1|Outcome|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
81296|NCT02076919|O5|Outcome|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
81297|NCT02076919|O4|Outcome|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
81298|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
81299|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
81300|NCT02076919|O1|Outcome|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
81301|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
81302|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
81303|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
81304|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
81305|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
81306|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
81307|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
81308|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
81309|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
81310|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
81311|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
81312|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
81313|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
81314|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
81315|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
81316|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
81317|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
81318|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
81319|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
81320|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
81321|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
81322|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
81323|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
81324|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
81325|NCT02076919|O7|Outcome|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
81326|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
81327|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
81328|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
81329|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
81330|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
81331|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
81332|NCT02076919|O5|Outcome|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
81333|NCT02076919|O4|Outcome|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
81334|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
81335|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
81336|NCT02076919|O1|Outcome|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
81337|NCT02076919|E12|Reported Event|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
81338|NCT02076919|E11|Reported Event|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
81339|NCT02076919|E10|Reported Event|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
81340|NCT02076919|E9|Reported Event|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
81341|NCT02076919|E8|Reported Event|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
81342|NCT02076919|E7|Reported Event|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
81343|NCT02076919|E6|Reported Event|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
81344|NCT02076919|E5|Reported Event|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
81345|NCT02076919|E4|Reported Event|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
81346|NCT02076919|E3|Reported Event|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
81347|NCT02076919|E2|Reported Event|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
81348|NCT02076919|E1|Reported Event|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
81349|NCT02076334|B5|Baseline|Total|Total of all reporting groups
81350|NCT02076334|B4|Baseline|Test Garment + Test Garment|"Far Infrared Fabric during exercise + Far Infrared Fabric at night~Far Infrared Fabric"
81351|NCT02076334|B3|Baseline|Normal Garment + Normal Garment|"Spandex during exercise + Spandex at night~Spandex"
81352|NCT02076334|B2|Baseline|Normal Garment + Test Garment at Night|"Spandex during exercise + Far Infrared Fabric at night~Far Infrared Fabric~Spandex"
81353|NCT02076334|B1|Baseline|Compression + Normal Garment|"Far Infrared Fabric during exercise + Spandex at night~Far Infrared Fabric~Spandex"
81354|NCT02076334|P4|Participant Flow|Test Garment + Test Garment|"Far Infrared Fabric during exercise + Far Infrared Fabric at night~Far Infrared Fabric"
81355|NCT02076334|P3|Participant Flow|Normal Garment + Normal Garment|"Spandex during exercise + Spandex at night~Spandex"
81356|NCT02076334|P2|Participant Flow|Normal Garment + Test Garment at Night|"Spandex during exercise + Far Infrared Fabric at night~Far Infrared Fabric~Spandex"
81357|NCT02076334|P1|Participant Flow|Compression + Normal Garment|"Far Infrared Fabric during exercise + Spandex at night~Far Infrared Fabric~Spandex"
81358|NCT02076334|O4|Outcome|Test Garment + Test Garment|"Far Infrared Fabric during exercise + Far Infrared Fabric at night~Far Infrared Fabric"
81359|NCT02076334|O3|Outcome|Normal Garment + Normal Garment|"Spandex during exercise + Spandex at night~Spandex"
81360|NCT02076334|O2|Outcome|Normal Garment + Test Garment at Night|"Spandex during exercise + Far Infrared Fabric at night~Far Infrared Fabric~Spandex"
81361|NCT02076334|O1|Outcome|Compression + Normal Garment|"Far Infrared Fabric during exercise + Spandex at night~Far Infrared Fabric~Spandex"
81362|NCT02076334|O4|Outcome|Test Garment + Test Garment|"Far Infrared Fabric during exercise + Far Infrared Fabric at night~Far Infrared Fabric"
81363|NCT02076334|O3|Outcome|Normal Garment + Normal Garment|"Spandex during exercise + Spandex at night~Spandex"
81364|NCT02076334|O2|Outcome|Normal Garment + Test Garment at Night|"Spandex during exercise + Far Infrared Fabric at night~Far Infrared Fabric~Spandex"
81365|NCT02076334|O1|Outcome|Compression + Normal Garment|"Far Infrared Fabric during exercise + Spandex at night~Far Infrared Fabric~Spandex"
81366|NCT02076334|E4|Reported Event|Test Garment + Test Garment|"Far Infrared Fabric during exercise + Far Infrared Fabric at night~Far Infrared Fabric"
81367|NCT02076334|E3|Reported Event|Normal Garment + Normal Garment|"Spandex during exercise + Spandex at night~Spandex"
81368|NCT02076334|E2|Reported Event|Normal Garment + Test Garment at Night|"Spandex during exercise + Far Infrared Fabric at night~Far Infrared Fabric~Spandex"
81369|NCT02076334|E1|Reported Event|Compression + Normal Garment|"Far Infrared Fabric during exercise + Spandex at night~Far Infrared Fabric~Spandex"
81370|NCT02076321|B3|Baseline|Total|Total of all reporting groups
81371|NCT02076321|B2|Baseline|NSAID (Ibuprofen)|"Study group~Ibuprofen: ibuprofen for pain control with dose and frequency 4-10mg/kg/dose. Maximum of 40mg/kg/day, not to exceed 3,200mg/day. Maximum one-time dose of 800mg."
81372|NCT02076321|B1|Baseline|Acetaminophen|"control group~Acetaminophen: acetaminophen for pain control with dose and frequency of 10-15mg/kg/dose, Maximum dose 1000mg. Maximum amount per day: 75mg/kg (not to exceed 4g/day)."
81373|NCT02076321|P2|Participant Flow|NSAID (Ibuprofen)|"Study group~Ibuprofen: ibuprofen for pain control with dose and frequency 4-10mg/kg/dose. Maximum of 40mg/kg/day, not to exceed 3,200mg/day. Maximum one-time dose of 800mg."
81374|NCT02076321|P1|Participant Flow|Acetaminophen|"control group~Acetaminophen: acetaminophen for pain control with dose and frequency of 10-15mg/kg/dose, Maximum dose 1000mg. Maximum amount per day: 75mg/kg (not to exceed 4g/day)."
81375|NCT02076321|O2|Outcome|NSAID (Ibuprofen)|"Study group~Ibuprofen: ibuprofen for pain control with dose and frequency 4-10mg/kg/dose. Maximum of 40mg/kg/day, not to exceed 3,200mg/day. Maximum one-time dose of 800mg."
81376|NCT02076321|O1|Outcome|Acetaminophen|"control group~Acetaminophen: acetaminophen for pain control with dose and frequency of 10-15mg/kg/dose, Maximum dose 1000mg. Maximum amount per day: 75mg/kg (not to exceed 4g/day)."
81377|NCT02076321|E2|Reported Event|NSAID (Ibuprofen)|"Study group~Ibuprofen: ibuprofen for pain control with dose and frequency 4-10mg/kg/dose. Maximum of 40mg/kg/day, not to exceed 3,200mg/day. Maximum one-time dose of 800mg."
81378|NCT02076321|E1|Reported Event|Acetaminophen|"control group~Acetaminophen: acetaminophen for pain control with dose and frequency of 10-15mg/kg/dose, Maximum dose 1000mg. Maximum amount per day: 75mg/kg (not to exceed 4g/day)."
81379|NCT02076243|B1|Baseline|Nab-paclitaxel|"weekly dosed nab-paclitaxel chemotherapy (days 1, 8 , 15 of a 28 day cycle) administered as an I.V. infusion over approximately 30 minutes. Dosage is determined by weight and height of participant.~nab-paclitaxel: nab-paclitaxel (abraxane) administered weekly (days 1,8, and 15 of 28 day cycle) to patients with unresectable locoregional or distantly metastatic cutaneous squamous cell carcinoma (SCC)."
81380|NCT02076243|P1|Participant Flow|Nab-paclitaxel|"weekly dosed nab-paclitaxel chemotherapy (days 1, 8 , 15 of a 28 day cycle) administered as an I.V. infusion over approximately 30 minutes. Dosage is determined by weight and height of participant.~nab-paclitaxel: nab-paclitaxel (abraxane) administered weekly (days 1,8, and 15 of 28 day cycle) to patients with unresectable locoregional or distantly metastatic cutaneous squamous cell carcinoma (SCC)."
81381|NCT02076243|O1|Outcome|Nab-paclitaxel|"weekly dosed nab-paclitaxel chemotherapy (days 1, 8 , 15 of a 28 day cycle) administered as an I.V. infusion over approximately 30 minutes. Dosage is determined by weight and height of participant.~nab-paclitaxel: nab-paclitaxel (abraxane) administered weekly (days 1,8, and 15 of 28 day cycle) to patients with unresectable locoregional or distantly metastatic cutaneous squamous cell carcinoma (SCC)."
81382|NCT02076243|O1|Outcome|Nab-paclitaxel|"weekly dosed nab-paclitaxel chemotherapy (days 1, 8 , 15 of a 28 day cycle) administered as an I.V. infusion over approximately 30 minutes. Dosage is determined by weight and height of participant.~nab-paclitaxel: nab-paclitaxel (abraxane) administered weekly (days 1,8, and 15 of 28 day cycle) to patients with unresectable locoregional or distantly metastatic cutaneous squamous cell carcinoma (SCC)."
81383|NCT02076243|O1|Outcome|Nab-paclitaxel|"weekly dosed nab-paclitaxel chemotherapy (days 1, 8 , 15 of a 28 day cycle) administered as an I.V. infusion over approximately 30 minutes. Dosage is determined by weight and height of participant.~nab-paclitaxel: nab-paclitaxel (abraxane) administered weekly (days 1,8, and 15 of 28 day cycle) to patients with unresectable locoregional or distantly metastatic cutaneous squamous cell carcinoma (SCC)."
81384|NCT02076243|O1|Outcome|Nab-paclitaxel|"weekly dosed nab-paclitaxel chemotherapy (days 1, 8 , 15 of a 28 day cycle) administered as an I.V. infusion over approximately 30 minutes. Dosage is determined by weight and height of participant.~nab-paclitaxel: nab-paclitaxel (abraxane) administered weekly (days 1,8, and 15 of 28 day cycle) to patients with unresectable locoregional or distantly metastatic cutaneous squamous cell carcinoma (SCC)."
81385|NCT02076243|O1|Outcome|Nab-paclitaxel|"weekly dosed nab-paclitaxel chemotherapy (days 1, 8 , 15 of a 28 day cycle) administered as an I.V. infusion over approximately 30 minutes. Dosage is determined by weight and height of participant.~nab-paclitaxel: nab-paclitaxel (abraxane) administered weekly (days 1,8, and 15 of 28 day cycle) to patients with unresectable locoregional or distantly metastatic cutaneous squamous cell carcinoma (SCC)."
81386|NCT02076243|E1|Reported Event|Nab-paclitaxel|"weekly dosed nab-paclitaxel chemotherapy (days 1, 8 , 15 of a 28 day cycle) administered as an I.V. infusion over approximately 30 minutes. Dosage is determined by weight and height of participant.~nab-paclitaxel: nab-paclitaxel (abraxane) administered weekly (days 1,8, and 15 of 28 day cycle) to patients with unresectable locoregional or distantly metastatic cutaneous squamous cell carcinoma (SCC)."
81387|NCT02076178|B3|Baseline|Total|Total of all reporting groups
81388|NCT02076178|B2|Baseline|Cabotegravir|Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.
81389|NCT02076178|B1|Baseline|Placebo|Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo.
81390|NCT02076178|P2|Participant Flow|Cabotegravir|Eligible participants received daily oral cabotegravir 30 milligrams (mg) tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.
81391|NCT02076178|P1|Participant Flow|Placebo|Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received intramuscular (IM) injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo.
81392|NCT02076178|O2|Outcome|Cabotegravir|Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.
81393|NCT02076178|O1|Outcome|Placebo|Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo.
81394|NCT02076178|O2|Outcome|Cabotegravir|Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.
81395|NCT02076178|O1|Outcome|Placebo|Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo.
81396|NCT02076178|O2|Outcome|Cabotegravir|Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.
81397|NCT02076178|O1|Outcome|Placebo|Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo.
81398|NCT02076178|O2|Outcome|Cabotegravir|Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.
81399|NCT02076178|O1|Outcome|Placebo|Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo.
81400|NCT02076178|O1|Outcome|Cabotegravir|Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.
81401|NCT02076178|O1|Outcome|Cabotegravir|Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.
81402|NCT02076178|O1|Outcome|Cabotegravir|Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.
81403|NCT02076178|O1|Outcome|Cabotegravir|Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.
81453|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81454|NCT02075840|O2|Outcome|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81404|NCT02076178|O1|Outcome|Cabotegravir|Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.
81405|NCT02076178|O1|Outcome|Cabotegravir|Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.
81406|NCT02076178|O2|Outcome|Cabotegravir|Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.
81407|NCT02076178|O1|Outcome|Placebo|Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo.
81408|NCT02076178|O2|Outcome|Cabotegravir|Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.
81409|NCT02076178|O1|Outcome|Placebo|Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo.
81410|NCT02076178|O2|Outcome|Cabotegravir|Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.
81411|NCT02076178|O1|Outcome|Placebo|Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo.
81412|NCT02076178|O2|Outcome|Cabotegravir|Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.
81413|NCT02076178|O1|Outcome|Placebo|Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo.
81414|NCT02076178|O2|Outcome|Cabotegravir|Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.
81415|NCT02076178|O1|Outcome|Placebo|Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo.
81416|NCT02076178|O2|Outcome|Cabotegravir|Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.
81417|NCT02076178|O1|Outcome|Placebo|Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12W intervals (W5, W17, and W29). The IM injection consisted of 800 mg of placebo.
81418|NCT02076178|O2|Outcome|Cabotegravir|Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.
81419|NCT02076178|O1|Outcome|Placebo|Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo.
81420|NCT02076178|E2|Reported Event|Cabotegravir|Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.
81421|NCT02076178|E1|Reported Event|Placebo|Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo.
81422|NCT02076009|B3|Baseline|Total|Total of all reporting groups
81423|NCT02076009|B2|Baseline|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
81424|NCT02076009|B1|Baseline|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
81425|NCT02076009|P2|Participant Flow|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
81426|NCT02076009|P1|Participant Flow|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
81427|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
81428|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
81429|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
81430|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
81431|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
81432|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
81455|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81456|NCT02075840|O2|Outcome|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81433|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
81434|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
81435|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
81436|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
81437|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
81438|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
81439|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
81440|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
81441|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
81442|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
81443|NCT02076009|E2|Reported Event|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
81444|NCT02076009|E1|Reported Event|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
81445|NCT02075840|B3|Baseline|Total|Total of all reporting groups
81446|NCT02075840|B2|Baseline|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81447|NCT02075840|B1|Baseline|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81448|NCT02075840|P2|Participant Flow|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81449|NCT02075840|P1|Participant Flow|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81450|NCT02075840|O2|Outcome|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81451|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81452|NCT02075840|O2|Outcome|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81457|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81458|NCT02075840|O2|Outcome|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81459|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81460|NCT02075840|O2|Outcome|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81461|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81462|NCT02075840|O2|Outcome|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81463|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81464|NCT02075840|O2|Outcome|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81465|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81466|NCT02075840|O2|Outcome|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81467|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81468|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81469|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81470|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81471|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81472|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81473|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81474|NCT02075840|O2|Outcome|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81475|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81476|NCT02075840|O2|Outcome|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81477|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81478|NCT02075840|O2|Outcome|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81479|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81480|NCT02075840|O2|Outcome|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81481|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81482|NCT02075840|O2|Outcome|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81483|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81484|NCT02075840|O2|Outcome|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81485|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81486|NCT02075840|O2|Outcome|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81487|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81488|NCT02075840|O2|Outcome|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81489|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81490|NCT02075840|O2|Outcome|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
84002|NCT02061358|P8|Participant Flow|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
81491|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81492|NCT02075840|O2|Outcome|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81493|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81494|NCT02075840|O2|Outcome|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81495|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81496|NCT02075840|O2|Outcome|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81497|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81498|NCT02075840|O2|Outcome|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81499|NCT02075840|O1|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81500|NCT02075840|E2|Reported Event|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81501|NCT02075840|E1|Reported Event|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
81502|NCT02075658|B3|Baseline|Total|Total of all reporting groups
81503|NCT02075658|B2|Baseline|AirSeal® System-Interventional|"The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port).~AirSeal® System-Interventional: The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port). The device enables peritoneal access with a novel mechanism to maintain pneumoperitoneum without a mechanical seal."
81504|NCT02075658|B1|Baseline|Conventional Insufflation and Trocars|"Subjects enrolled in this study arm will have their procedure performed using either the conventional insufflator and trocars. This system have been cleared for use by the FDA's 510 (k)process and are currently employed in clinical practice, including at UC Irvine Medical Center.~Conventional Insufflator and Trocar: Conventional insufflator and trocars are used in standard procedures and will serve as the base for comparison of the study device (AirSeal® System)."
81505|NCT02075658|P2|Participant Flow|AirSeal® System-Interventional|"The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port).~AirSeal® System-Interventional: The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port). The device enables peritoneal access with a novel mechanism to maintain pneumoperitoneum without a mechanical seal."
81506|NCT02075658|P1|Participant Flow|Conventional Insufflation and Trocars|"Subjects enrolled in this study arm will have their procedure performed using either the conventional insufflator and trocars. This system have been cleared for use by the FDA's 510 (k)process and are currently employed in clinical practice, including at UC Irvine Medical Center.~Conventional Insufflator and Trocar: Conventional insufflator and trocars are used in standard procedures and will serve as the base for comparison of the study device (AirSeal® System)."
81507|NCT02075658|O2|Outcome|AirSeal® System-Interventional|"The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port).~AirSeal® System-Interventional: The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port). The device enables peritoneal access with a novel mechanism to maintain pneumoperitoneum without a mechanical seal."
81508|NCT02075658|O1|Outcome|Conventional Insufflation and Trocars|"Subjects enrolled in this study arm will have their procedure performed using either the conventional insufflator and trocars. This system have been cleared for use by the FDA's 510 (k)process and are currently employed in clinical practice, including at UC Irvine Medical Center.~Conventional Insufflator and Trocar: Conventional insufflator and trocars are used in standard procedures and will serve as the base for comparison of the study device (AirSeal® System)."
81509|NCT02075658|O2|Outcome|AirSeal® System-Interventional|"The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port).~AirSeal® System-Interventional: The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port). The device enables peritoneal access with a novel mechanism to maintain pneumoperitoneum without a mechanical seal."
81510|NCT02075658|O1|Outcome|Conventional Insufflation and Trocars|"Subjects enrolled in this study arm will have their procedure performed using either the conventional insufflator and trocars. This system have been cleared for use by the FDA's 510 (k)process and are currently employed in clinical practice, including at UC Irvine Medical Center.~Conventional Insufflator and Trocar: Conventional insufflator and trocars are used in standard procedures and will serve as the base for comparison of the study device (AirSeal® System)."
81511|NCT02075658|E2|Reported Event|AirSeal® System-Interventional|"The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port).~AirSeal® System-Interventional: The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port). The device enables peritoneal access with a novel mechanism to maintain pneumoperitoneum without a mechanical seal."
81512|NCT02075658|E1|Reported Event|Conventional Insufflation and Trocars|"Subjects enrolled in this study arm will have their procedure performed using either the conventional insufflator and trocars. This system have been cleared for use by the FDA's 510 (k)process and are currently employed in clinical practice, including at UC Irvine Medical Center.~Conventional Insufflator and Trocar: Conventional insufflator and trocars are used in standard procedures and will serve as the base for comparison of the study device (AirSeal® System)."
81513|NCT02075632|B3|Baseline|Total|Total of all reporting groups
81514|NCT02075632|B2|Baseline|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used
81515|NCT02075632|B1|Baseline|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
81516|NCT02075632|P2|Participant Flow|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.
81517|NCT02075632|P1|Participant Flow|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
81518|NCT02075632|O2|Outcome|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.
81519|NCT02075632|O1|Outcome|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
81520|NCT02075632|O2|Outcome|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.
81521|NCT02075632|O1|Outcome|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
81522|NCT02075632|O2|Outcome|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.
81523|NCT02075632|O1|Outcome|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
81524|NCT02075632|E2|Reported Event|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.
81525|NCT02075632|E1|Reported Event|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
81526|NCT02075515|B4|Baseline|Total|Total of all reporting groups
81527|NCT02075515|B3|Baseline|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81528|NCT02075515|B2|Baseline|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81529|NCT02075515|B1|Baseline|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81530|NCT02075515|P3|Participant Flow|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81531|NCT02075515|P2|Participant Flow|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81532|NCT02075515|P1|Participant Flow|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.
81533|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81534|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81535|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81536|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81537|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81538|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.
81539|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81540|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81665|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81541|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81542|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81543|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81544|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81545|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81546|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81547|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.
81548|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81549|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81550|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81551|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81552|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81553|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.
81554|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81555|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81556|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.
81557|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81558|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81559|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81560|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81561|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81562|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81563|NCT02075515|E3|Reported Event|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81564|NCT02075515|E2|Reported Event|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
81565|NCT02075515|E1|Reported Event|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.
81566|NCT02075463|B1|Baseline|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
81567|NCT02075463|P1|Participant Flow|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
81568|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
81569|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
81570|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
81571|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
81572|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
81573|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
81574|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
81575|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
81576|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
81577|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
81578|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
81579|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
81580|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
81581|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
81582|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
81583|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
81584|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
81585|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
81586|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
81587|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
81661|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81666|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81588|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
81589|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
81590|NCT02075463|E1|Reported Event|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
81591|NCT02075411|B5|Baseline|Total|Total of all reporting groups
81592|NCT02075411|B4|Baseline|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
81593|NCT02075411|B3|Baseline|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
81594|NCT02075411|B2|Baseline|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Females Single shot peripheral nerve block"
81595|NCT02075411|B1|Baseline|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Males Single shot peripheral nerve block"
81596|NCT02075411|P4|Participant Flow|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
81597|NCT02075411|P3|Participant Flow|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
81598|NCT02075411|P2|Participant Flow|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Females Single shot peripheral nerve block"
81599|NCT02075411|P1|Participant Flow|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Males Single shot peripheral nerve block"
81600|NCT02075411|O4|Outcome|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
81601|NCT02075411|O3|Outcome|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
81602|NCT02075411|O2|Outcome|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Females Single shot peripheral nerve block"
81603|NCT02075411|O1|Outcome|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Males Single shot peripheral nerve block"
81604|NCT02075411|O4|Outcome|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
81605|NCT02075411|O3|Outcome|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
81606|NCT02075411|O2|Outcome|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Females Single shot peripheral nerve block"
81607|NCT02075411|O1|Outcome|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Males Single shot peripheral nerve block"
81608|NCT02075411|O4|Outcome|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
81609|NCT02075411|O3|Outcome|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
81610|NCT02075411|O2|Outcome|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Females Single shot peripheral nerve block"
81611|NCT02075411|O1|Outcome|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Males Single shot peripheral nerve block"
81612|NCT02075411|E4|Reported Event|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
81613|NCT02075411|E3|Reported Event|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
81614|NCT02075411|E2|Reported Event|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Females Single shot peripheral nerve block"
81615|NCT02075411|E1|Reported Event|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Males Single shot peripheral nerve block"
81616|NCT02075320|B1|Baseline|Stationary Digital Chest Tomosynthesis|"All patients will be included in the experimental group.~Stationary Digital Chest Tomosynthesis: The study scan, s-DCT, will be performed within two weeks of his/her clinical evaluations by chest CT and CR. There cannot be any intervening therapies or procedures (i.e. biopsy or excision of lesions) done in between the SOC imaging and the s-DCT. In the event that CRs are not included in the SOC imaging or are unusable (outside of acceptable window or poor quality), the scout image acquired by CT will be used in place of a CR.~Images will be acquired by a trained radiologist technologist. The technologist will comfortably position the patient in the supine position on the imaging table. Then, all patients will have a breath held s-DCT scan in an anterior-posterior direction."
81617|NCT02075320|P1|Participant Flow|Stationary Digital Chest Tomosynthesis|"All patients will be included in the experimental group.~Stationary Digital Chest Tomosynthesis (s-DCT): The study scan, s-DCT, will be performed within two weeks of his/her clinical evaluations by chest computed tomography (CT) and chest radiograph (CR). There cannot be any intervening therapies or procedures (i.e. biopsy or excision of lesions) done in between the standard of care (SOC) imaging and the s-DCT. In the event that CRs are not included in the SOC imaging or are unusable (outside of acceptable window or poor quality), the scout image acquired by CT will be used in place of a CR.~Images will be acquired by a trained radiologist technologist. The technologist will comfortably position the patient in the supine position on the imaging table. Then, all patients will have a breath held s-DCT scan in an anterior-posterior direction."
81618|NCT02075320|O1|Outcome|Stationary Digital Chest Tomosynthesis|"All patients will be included in the experimental group.~Stationary Digital Chest Tomosynthesis: The study scan, s-DCT, will be performed within two weeks of his/her clinical evaluations by chest CT and CR. There cannot be any intervening therapies or procedures (i.e. biopsy or excision of lesions) done in between the SOC imaging and the s-DCT. In the event that CRs are not included in the SOC imaging or are unusable (outside of acceptable window or poor quality), the scout image acquired by CT will be used in place of a CR.~Images will be acquired by a trained radiologist technologist. The technologist will comfortably position the patient in the supine position on the imaging table. Then, all patients will have a breath held s-DCT scan in an anterior-posterior direction."
81619|NCT02075320|O1|Outcome|Stationary Digital Chest Tomosynthesis|"All patients will be included in the experimental group.~Stationary Digital Chest Tomosynthesis: The study scan, s-DCT, will be performed within two weeks of his/her clinical evaluations by chest CT and CR. There cannot be any intervening therapies or procedures (i.e. biopsy or excision of lesions) done in between the SOC imaging and the s-DCT. In the event that CRs are not included in the SOC imaging or are unusable (outside of acceptable window or poor quality), the scout image acquired by CT will be used in place of a CR.~Images will be acquired by a trained radiologist technologist. The technologist will comfortably position the patient in the supine position on the imaging table. Then, all patients will have a breath held s-DCT scan in an anterior-posterior direction."
81662|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81663|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81664|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81620|NCT02075320|O1|Outcome|Stationary Digital Chest Tomosynthesis|"All patients will be included in the experimental group.~Stationary Digital Chest Tomosynthesis: The study scan, s-DCT, will be performed within two weeks of his/her clinical evaluations by chest CT and CR. There cannot be any intervening therapies or procedures (i.e. biopsy or excision of lesions) done in between the SOC imaging and the s-DCT. In the event that CRs are not included in the SOC imaging or are unusable (outside of acceptable window or poor quality), the scout image acquired by CT will be used in place of a CR.~Images will be acquired by a trained radiologist technologist. The technologist will comfortably position the patient in the supine position on the imaging table. Then, all patients will have a breath held s-DCT scan in an anterior-posterior direction."
81621|NCT02075320|O1|Outcome|Stationary Digital Chest Tomosynthesis|"All patients will be included in the experimental group.~Stationary Digital Chest Tomosynthesis: The study scan, s-DCT, will be performed within two weeks of his/her clinical evaluations by chest CT and CR. There cannot be any intervening therapies or procedures (i.e. biopsy or excision of lesions) done in between the SOC imaging and the s-DCT. In the event that CRs are not included in the SOC imaging or are unusable (outside of acceptable window or poor quality), the scout image acquired by CT will be used in place of a CR.~Images will be acquired by a trained radiologist technologist. The technologist will comfortably position the patient in the supine position on the imaging table. Then, all patients will have a breath held s-DCT scan in an anterior-posterior direction."
81622|NCT02075320|E1|Reported Event|Stationary Digital Chest Tomosynthesis|"All patients will be included in the experimental group.~Stationary Digital Chest Tomosynthesis: The study scan, s-DCT, will be performed within two weeks of his/her clinical evaluations by chest CT and CR. There cannot be any intervening therapies or procedures (i.e. biopsy or excision of lesions) done in between the SOC imaging and the s-DCT. In the event that CRs are not included in the SOC imaging or are unusable (outside of acceptable window or poor quality), the scout image acquired by CT will be used in place of a CR.~Images will be acquired by a trained radiologist technologist. The technologist will comfortably position the patient in the supine position on the imaging table. Then, all patients will have a breath held s-DCT scan in an anterior-posterior direction."
81623|NCT02075255|B4|Baseline|Total|Total of all reporting groups
81624|NCT02075255|B3|Baseline|Placebo|Placebo administered subcutaneously
81625|NCT02075255|B2|Baseline|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81626|NCT02075255|B1|Baseline|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81627|NCT02075255|P3|Participant Flow|Placebo|Placebo administered subcutaneously
81628|NCT02075255|P2|Participant Flow|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81629|NCT02075255|P1|Participant Flow|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81630|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81631|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81632|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81633|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81634|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81635|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81636|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81637|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81638|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81639|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81640|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81641|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81642|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81643|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81644|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81645|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81646|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81647|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81648|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81649|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81650|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81651|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81652|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81653|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81654|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81655|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81656|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81657|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81658|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81659|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81660|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
84003|NCT02061358|P7|Participant Flow|720 mg UV-4B|UV-4B 720 mg oral, single dose
81667|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81668|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81669|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81670|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81671|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81672|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81673|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81674|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81675|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81676|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81677|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81678|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81679|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81680|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81681|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81682|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81683|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81684|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81685|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81686|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81687|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81688|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81689|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81690|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81691|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81692|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81693|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81694|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81695|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81696|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81697|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81698|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81699|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81700|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81701|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81702|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81703|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81704|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81705|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81706|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81707|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81708|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81709|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81710|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81711|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81712|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81713|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81714|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81715|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81716|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81717|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81718|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81719|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81720|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81721|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81722|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81723|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81724|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81725|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81726|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81727|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81728|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81729|NCT02075255|O3|Outcome|Placebo|Placebo administered subcutaneously
81730|NCT02075255|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81731|NCT02075255|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81732|NCT02075255|E3|Reported Event|Placebo|Placebo administered subcutaneously
81733|NCT02075255|E2|Reported Event|Benra 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks
81734|NCT02075255|E1|Reported Event|Benra 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
81735|NCT02075125|B3|Baseline|Total|Total of all reporting groups
81736|NCT02075125|B2|Baseline|Ticagrelor|Patients administer Ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
81737|NCT02075125|B1|Baseline|Prasugrel|Patient administer Prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
81738|NCT02075125|P2|Participant Flow|Ticagrelor|Patient administer Ticagrelor 180 mg as loading dose followed by 90 mg twice a day as maintenance dose.
81739|NCT02075125|P1|Participant Flow|Prasugrel|Patient administer Prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
81740|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
81741|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
81742|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
81743|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
81744|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
81745|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
81746|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
81747|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
81748|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
81749|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
81750|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
81751|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
81752|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
81753|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
81754|NCT02075125|E2|Reported Event|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
81755|NCT02075125|E1|Reported Event|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
81756|NCT02075073|B4|Baseline|Total|Total of all reporting groups
81757|NCT02075073|B3|Baseline|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~US sourced Herceptin®"
81758|NCT02075073|B2|Baseline|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~EU sourced Herceptin®"
81759|NCT02075073|B1|Baseline|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)~SB3"
81760|NCT02075073|P3|Participant Flow|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~US sourced Herceptin®"
81761|NCT02075073|P2|Participant Flow|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~EU sourced Herceptin®"
81762|NCT02075073|P1|Participant Flow|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)~SB3"
81763|NCT02075073|O3|Outcome|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~US sourced Herceptin®"
81764|NCT02075073|O2|Outcome|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~EU sourced Herceptin®"
81765|NCT02075073|O1|Outcome|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)~SB3"
81766|NCT02075073|O3|Outcome|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~US sourced Herceptin®"
81767|NCT02075073|O2|Outcome|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~EU sourced Herceptin®"
81768|NCT02075073|O1|Outcome|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)~SB3"
81769|NCT02075073|O3|Outcome|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~US sourced Herceptin®"
81770|NCT02075073|O2|Outcome|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~EU sourced Herceptin®"
81771|NCT02075073|O1|Outcome|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)~SB3"
81772|NCT02075073|O3|Outcome|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~US sourced Herceptin®"
81773|NCT02075073|O2|Outcome|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~EU sourced Herceptin®"
81774|NCT02075073|O1|Outcome|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)~SB3"
81775|NCT02075073|E3|Reported Event|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~US sourced Herceptin®"
81776|NCT02075073|E2|Reported Event|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~EU sourced Herceptin®"
81777|NCT02075073|E1|Reported Event|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)~SB3"
81778|NCT02075021|B1|Baseline|Lenalidomide and Nab-paclitaxel|"100 mg/m^2 of Abraxane weekly for 3 weeks and 10 mg Revlimid daily for 21 days, with a dose escalation for Revlimid to 15 mg and to 25 mg. One cycle is 4 weeks. Dose de-escalations will also be performed for both drugs as necessary. Patients will be treated until disease progression.~Lenalidomide~nab-paclitaxel"
81779|NCT02075021|P1|Participant Flow|Lenalidomide and Nab-paclitaxel|"100 mg/m^2 of Abraxane weekly for 3 weeks and 10 mg Revlimid daily for 21 days, with a dose escalation for Revlimid to 15 mg and to 25 mg. One cycle is 4 weeks. Dose de-escalations will also be performed for both drugs as necessary. Patients will be treated until disease progression.~Lenalidomide~nab-paclitaxel"
81780|NCT02075021|O1|Outcome|Lenalidomide and Nab-paclitaxel|"100 mg/m^2 of Abraxane weekly for 3 weeks and 10 mg Revlimid daily for 21 days, with a dose escalation for Revlimid to 15 mg and to 25 mg. One cycle is 4 weeks. Dose de-escalations will also be performed for both drugs as necessary. Patients will be treated until disease progression.~Lenalidomide~nab-paclitaxel"
81781|NCT02075021|O1|Outcome|Lenalidomide and Nab-paclitaxel|"100 mg/m^2 of Abraxane weekly for 3 weeks and 10 mg Revlimid daily for 21 days, with a dose escalation for Revlimid to 15 mg and to 25 mg. One cycle is 4 weeks. Dose de-escalations will also be performed for both drugs as necessary. Patients will be treated until disease progression.~Lenalidomide~nab-paclitaxel"
81782|NCT02075021|E1|Reported Event|Lenalidomide and Nab-paclitaxel|"100 mg/m^2 of Abraxane weekly for 3 weeks and 10 mg Revlimid daily for 21 days, with a dose escalation for Revlimid to 15 mg and to 25 mg. One cycle is 4 weeks. Dose de-escalations will also be performed for both drugs as necessary. Patients will be treated until disease progression.~Lenalidomide~nab-paclitaxel"
81783|NCT02075008|B1|Baseline|QGE031 Every 4 Weeks (q4w)|QGE031 240 mg subcutaneously q4w
81784|NCT02075008|P1|Participant Flow|QGE031 Every 4 Weeks (q4w)|QGE031 240 mg subcutaneously q4w
81785|NCT02075008|O1|Outcome|QGE031 Every 4 Weeks (q4w)|QGE031 240 mg subcutaneously q4w
81786|NCT02075008|E1|Reported Event|QGE031 Every 4 Weeks (q4w)|QGE031 240 mg subcutaneously q4w
81787|NCT02074995|B1|Baseline|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
81788|NCT02074995|P3|Participant Flow|BVS857 Group 1B/1C, 2, 3, 4 Double Blind|
81789|NCT02074995|P2|Participant Flow|Placebo Group 1B/1C, 2, 3, 4|
81790|NCT02074995|P1|Participant Flow|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
81791|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
81792|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
81793|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
81794|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
81795|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
81796|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
81797|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
81798|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
81799|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
81800|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
81801|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
81802|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
81803|NCT02074995|E1|Reported Event|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
81804|NCT02074982|B3|Baseline|Total|Total of all reporting groups
81805|NCT02074982|B2|Baseline|Ustekinumab|patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
81806|NCT02074982|B1|Baseline|AIN457 300 mg|patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive
81807|NCT02074982|P2|Participant Flow|Ustekinumab|patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
81808|NCT02074982|P1|Participant Flow|AIN457 300 mg|patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive
81809|NCT02074982|O2|Outcome|Ustekinumab|patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
81810|NCT02074982|O1|Outcome|AIN457 300 mg|patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive
81811|NCT02074982|O2|Outcome|Ustekinumab|patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
81812|NCT02074982|O1|Outcome|AIN457 300 mg|patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive
81813|NCT02074982|O2|Outcome|Ustekinumab|patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
81814|NCT02074982|O1|Outcome|AIN457 300 mg|patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive
81815|NCT02074982|E2|Reported Event|Ustekinumab|patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
81816|NCT02074982|E1|Reported Event|AIN457 300 mg|patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive
81817|NCT02074904|B3|Baseline|Total|Total of all reporting groups
81818|NCT02074904|B2|Baseline|Placebo|"placebo~Placebo"
81819|NCT02074904|B1|Baseline|Topiramate|"up to 200mg/day orally (over 8 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)~Topiramate"
81820|NCT02074904|P2|Participant Flow|Placebo|"placebo~Placebo"
81821|NCT02074904|P1|Participant Flow|Topiramate|"up to 200mg/day orally (over 8 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)~Topiramate"
81822|NCT02074904|O2|Outcome|Placebo|"placebo~Placebo"
81823|NCT02074904|O1|Outcome|Topiramate|"up to 200mg/day orally (over 8 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)~Topiramate"
81824|NCT02074904|O2|Outcome|Placebo|"placebo~Placebo"
81825|NCT02074904|O1|Outcome|Topiramate|"up to 200mg/day orally (over 8 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)~Topiramate"
81826|NCT02074904|O2|Outcome|Placebo|"placebo~Placebo"
81827|NCT02074904|O1|Outcome|Topiramate|"up to 200mg/day orally (over 8 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)~Topiramate"
81828|NCT02074904|O2|Outcome|Placebo|"placebo~Placebo"
81829|NCT02074904|O1|Outcome|Topiramate|"up to 200mg/day orally (over 8 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)~Topiramate"
81830|NCT02074904|O2|Outcome|Placebo|"placebo~Placebo"
81831|NCT02074904|O1|Outcome|Topiramate|"up to 200mg/day orally (over 8 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)~Topiramate"
81832|NCT02074904|E2|Reported Event|Placebo|"placebo~Placebo"
81833|NCT02074904|E1|Reported Event|Topiramate|"up to 200mg/day orally (over 8 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)~Topiramate"
81834|NCT02074709|B3|Baseline|Total|Total of all reporting groups
81835|NCT02074709|B2|Baseline|Wound Infiltration|Wound infiltration with liposomal bupivacaine
81836|NCT02074709|B1|Baseline|TAP Block|TAP block with plain bupivacaine
81837|NCT02074709|P2|Participant Flow|Wound Infiltration|"Wound infiltration with liposomal bupivacaine~Liposomal bupivacaine: Group intraoperative: Wound infiltration with liposomal bupivacaine (Exparel) + IV acetaminophen 1000 mg IV + Ketorolac 30 mg IV~First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
81838|NCT02074709|P1|Participant Flow|TAP Block|"TAP block with plain bupivacaine~Plain bupivacaine: Intraoperative: TAP block with plain bupivacaine + Acetaminophen 1000 mg IV + Ketorolac 30 mg IV .~First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine.~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h,prn"
81839|NCT02074709|O2|Outcome|Wound Infiltration|"Wound infiltration with liposomal bupivacaine~Liposomal bupivacaine: Group intraoperative: Wound infiltration with liposomal bupivacaine (Exparel) + IV acetaminophen 1000 mg IV + Ketorolac 30 mg IV"
81840|NCT02074709|O1|Outcome|TAP Block|"TAP block with plain bupivacaine~Plain bupivacaine: Intraoperative: TAP block with plain bupivacaine + Acetaminophen 1000 mg IV + Ketorolac 30 mg IV ."
81841|NCT02074709|E2|Reported Event|Wound Infiltration|"Wound infiltration with liposomal bupivacaine~Liposomal bupivacaine: Group intraoperative: Wound infiltration with liposomal bupivacaine (Exparel) + IV acetaminophen 1000 mg IV + Ketorolac 30 mg IV~First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
81842|NCT02074709|E1|Reported Event|TAP Block|"TAP block with plain bupivacaine~Plain bupivacaine: Intraoperative: TAP block with plain bupivacaine + Acetaminophen 1000 mg IV + Ketorolac 30 mg IV .~First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine.~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h,prn"
81843|NCT02074553|B3|Baseline|Total|Total of all reporting groups
84004|NCT02061358|P6|Participant Flow|360 mg UV-4B|UV-4B 360 mg oral, single dose
81844|NCT02074553|B2|Baseline|Part 2 (Fed): Study Population|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A, B, C, and D according to any of the four treatment sequences in Part 2 of the study.
81845|NCT02074553|B1|Baseline|Part 1 (Fasted): Study Population|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A, B, C, and D according to any of the four treatment sequences in Part 1 of the study.
81846|NCT02074553|P8|Participant Flow|Part 2 (Fed): Treatment D Then C Then B Then A|Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment D (formulation containing 3% SLS) on Day 1 of the first intervention period; then Treatment C (formulation containing 12.5% SLS) on Day 1 of second intervention period (Day 11); then Treatment B (formulation containing 25% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment A (formulation containing 50% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
81847|NCT02074553|P7|Participant Flow|Part 2 (Fed): Treatment C Then A Then D Then B|Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment C (formulation containing 12.5% SLS) on Day 1 of the first intervention period; then Treatment A (formulation containing 50% SLS) on Day 1 of second intervention period (Day 11); then Treatment D (formulation containing 3% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment B (formulation containing 25% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
81848|NCT02074553|P6|Participant Flow|Part 2 (Fed): Treatment B Then D Then A Then C|Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment B (formulation containing 25% SLS) on Day 1 of the first intervention period; then Treatment D (formulation containing 3% SLS) on Day 1 of second intervention period (Day 11); then Treatment A (formulation containing 50% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment C (formulation containing 12.5% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
81849|NCT02074553|P5|Participant Flow|Part 2 (Fed): Treatment A Then B Then C Then D|Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment A (formulation containing 50% SLS) on Day 1 of the first intervention period; then Treatment B (formulation containing 25% SLS) on Day 1 of second intervention period (Day 11); then Treatment C (formulation containing 12.5% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment D (formulation containing 3% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
81850|NCT02074553|P4|Participant Flow|Part 1 (Fasted): Treatment D Then C Then B Then A|Participants following an overnight fast of at least 10 hours received 600 mg of alectinib as a capsule formulation orally in Part 1 of the study according to following treatment sequences. Treatment D (formulation containing 3% SLS) on Day 1 of the first intervention period; then Treatment C (formulation containing 12.5% SLS) on Day 1 of second intervention period (Day 11); then Treatment B (formulation containing 25% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment A (formulation containing 50% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
81851|NCT02074553|P3|Participant Flow|Part 1 (Fasted): Treatment C Then A Then D Then B|Participants following an overnight fast of at least 10 hours received 600 mg of alectinib as a capsule formulation orally in Part 1 of the study according to following treatment sequences. Treatment C (formulation containing 12.5% SLS) on Day 1 of the first intervention period; then Treatment A (formulation containing 50% SLS) on Day 1 of second intervention period (Day 11); then Treatment D (formulation containing 3% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment B (formulation containing 25% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
81852|NCT02074553|P2|Participant Flow|Part 1 (Fasted): Treatment B Then D Then A Then C|Participants following an overnight fast of at least 10 hours received 600 mg of alectinib as a capsule formulation orally in Part 1 of the study according to following treatment sequences. Treatment B (formulation containing 25% SLS) on Day 1 of the first intervention period; then Treatment D (formulation containing 3% SLS) on Day 1 of second intervention period (Day 11); then Treatment A (formulation containing 50% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment C (formulation containing 12.5% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
81853|NCT02074553|P1|Participant Flow|Part 1 (Fasted): Treatment A Then B Then C Then D|Participants following an overnight fast of at least 10 hours received 600 milligram (mg) of alectinib (RO5424802) as a capsule formulation (four 150 mg capsules) orally in Part 1 of the study according to following treatment sequences. Treatment A (Reference Treatment: formulation containing 50 percent [%]sodium lauryl sulfate [SLS]) on Day 1 of the first intervention period; then Treatment B (Test Treatment: formulation containing 25% SLS) on Day 1 of second intervention period (Day 11); then Treatment C (Test Treatment: formulation containing 12.5% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment D (Test Treatment: formulation containing 3% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
81854|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
82312|NCT02072980|E1|Reported Event|DAILIES TOTAL1|Delefilcon A contact lenses worn during Period 1 and Period 2
81855|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
81856|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
81857|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
81858|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
81859|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
81860|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
81861|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
81862|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
81863|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
81864|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
81865|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
81866|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
81867|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
81868|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
81869|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
81870|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
81871|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
81872|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
81873|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
81874|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
81875|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
81876|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
81877|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
81878|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
81879|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
81880|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
81881|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
81882|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
81883|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
81884|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
81885|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
81886|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
81887|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
81888|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
81889|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
81890|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
81891|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
81892|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
81893|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
81894|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
81895|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
81896|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
81897|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
81898|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
81899|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
82040|NCT02074514|O1|Outcome|SOF + RBV 16 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype (GT) 1 HCV infection
81900|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
81901|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
81902|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
81903|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
81904|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
81905|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
81906|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
81907|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
81908|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
81909|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
81910|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
81911|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
81912|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
81913|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
81914|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
81915|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
81916|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
81917|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
81918|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
81919|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
81920|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
81921|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
81922|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
81923|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
81924|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
81925|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
81926|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
81927|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
81928|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
81929|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
81930|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
81931|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
81932|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
81933|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
81934|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
81935|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
81936|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
81937|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
81938|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
81939|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
81940|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
81941|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
81942|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
81943|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
81944|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
82041|NCT02074514|O4|Outcome|SOF + RBV 24 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection
84005|NCT02061358|P5|Participant Flow|180 mg UV-4B|UV-4B 180 mg oral, single dose
81945|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
81946|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
81947|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
81948|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
81949|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
81950|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
81951|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
81952|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
81953|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
81954|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
81955|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
81956|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
81957|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
81958|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
81959|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
81960|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
81961|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
81962|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
81963|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
81964|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
81965|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
81966|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
81967|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
81968|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
81969|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
81970|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
81971|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
81972|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
81973|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
81974|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
81975|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
81976|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
81977|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
81978|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
81979|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
81980|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
81981|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
81982|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
81983|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
81984|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
81985|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
81986|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
81987|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
81988|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
81989|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
81990|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
81991|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
81992|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
81993|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
81994|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
81995|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
81996|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
81997|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
81998|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
81999|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
82000|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
82001|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
82002|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
82003|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
82004|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
82005|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
82006|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
82007|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
82008|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
82009|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
82010|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
82011|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
82012|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
82013|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
82014|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
82015|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
82016|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
82017|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
82018|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
82019|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
82020|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
82021|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
82022|NCT02074553|E8|Reported Event|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
82023|NCT02074553|E7|Reported Event|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
82024|NCT02074553|E6|Reported Event|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
82025|NCT02074553|E5|Reported Event|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
82026|NCT02074553|E4|Reported Event|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
82027|NCT02074553|E3|Reported Event|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
82028|NCT02074553|E2|Reported Event|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
82029|NCT02074553|E1|Reported Event|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
82030|NCT02074514|B5|Baseline|Total|Total of all reporting groups
82031|NCT02074514|B4|Baseline|SOF + RBV 24 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection
82032|NCT02074514|B3|Baseline|SOF + RBV 16 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype 3 HCV infection
82033|NCT02074514|B2|Baseline|SOF + RBV 24 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 1 HCV infection
82034|NCT02074514|B1|Baseline|SOF + RBV 16 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype (GT) 1 HCV infection
82035|NCT02074514|P2|Participant Flow|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks.
82036|NCT02074514|P1|Participant Flow|SOF+RBV 16 Weeks|Sofosbuvir (Sovaldi®; SOF) 400 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 16 weeks.
82037|NCT02074514|O4|Outcome|SOF + RBV 24 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection
82038|NCT02074514|O3|Outcome|SOF + RBV 16 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype 3 HCV infection
82039|NCT02074514|O2|Outcome|SOF + RBV 24 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 1 HCV infection
82630|NCT02070380|B2|Baseline|Dotarem 0.1 mmol/kg Then MultiHance 0.1 mmol/kg|Patients randomized to receive Dotarem 0.1 mmol/kg first
82042|NCT02074514|O3|Outcome|SOF + RBV 16 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype 3 HCV infection
82043|NCT02074514|O2|Outcome|SOF + RBV 24 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 1 HCV infection
82044|NCT02074514|O1|Outcome|SOF + RBV 16 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype (GT) 1 HCV infection
82045|NCT02074514|O2|Outcome|SOF + RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
82046|NCT02074514|O1|Outcome|SOF + RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
82047|NCT02074514|O4|Outcome|SOF + RBV 24 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection
82048|NCT02074514|O3|Outcome|SOF + RBV 16 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype 3 HCV infection
82049|NCT02074514|O2|Outcome|SOF + RBV 24 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 1 HCV infection
82050|NCT02074514|O1|Outcome|SOF + RBV 16 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype (GT) 1 HCV infection
82051|NCT02074514|E2|Reported Event|SOF + RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
82052|NCT02074514|E1|Reported Event|SOF + RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
82053|NCT02074384|B4|Baseline|Total|Total of all reporting groups
82054|NCT02074384|B3|Baseline|Clinicians|Clinicians completing the study visits.
82055|NCT02074384|B2|Baseline|Self Monitoring Blood Glucose|"Participants will self test for two weeks.~Self Monitoring Blood Glucose: Participants will use their own SMBG device."
82056|NCT02074384|B1|Baseline|Continuous Glucose Monitoring|"Participants will wear Continuous Glucose Monitoring for two weeks.~Continuous Glucose Monitor: CGM device for measurement of interstitial glucose on a 24/7 continuous cycle."
82057|NCT02074384|P3|Participant Flow|Clinicians|Clinicians completing study AGP visits.
82058|NCT02074384|P2|Participant Flow|Self Monitoring Blood Glucose|"Participants will self test for two weeks.~Self Monitoring Blood Glucose: Participants will use their own SMBG device."
82059|NCT02074384|P1|Participant Flow|Continuous Glucose Monitoring|"Participants will wear Continuous Glucose Monitoring for two weeks.~Continuous Glucose Monitor: CGM device for measurement of interstitial glucose on a 24/7 continuous cycle."
82060|NCT02074384|O3|Outcome|Clinicians|Clinicians completing the study visits.
82061|NCT02074384|O2|Outcome|Self Monitoring Blood Glucose|"Participants will self test for two weeks.~Self Monitoring Blood Glucose: Participants will use their own SMBG device."
82062|NCT02074384|O1|Outcome|Continuous Glucose Monitoring|"Participants will wear Continuous Glucose Monitoring for two weeks.~Continuous Glucose Monitor: CGM device for measurement of interstitial glucose on a 24/7 continuous cycle."
82063|NCT02074384|E3|Reported Event|Clinicians|"Clinicians completing study visits.~Clinician: Survey of clinicians after study visits"
82064|NCT02074384|E2|Reported Event|Self Monitoring Blood Glucose|"Participants will self test for two weeks.~Self Monitoring Blood Glucose: Participants will use their own SMBG device."
82065|NCT02074384|E1|Reported Event|Continuous Glucose Monitoring|"Participants will wear Continuous Glucose Monitoring for two weeks.~Continuous Glucose Monitor: CGM device for measurement of interstitial glucose on a 24/7 continuous cycle."
82066|NCT02074358|B1|Baseline|All Treated Participants|Treated population included all participants who received at least one dose of study medication. Participants received 10 mg apixaban BID on Days 1-3 and on Day 4 received a single dose of 10 mg apixaban followed 3 hours later by an IV infusion of 50 IU/kg prothrombin complex concentrate (PCC) (which was either Cofact or Beriplex P/N) or the participant received an IV infusion of placebo (saline solution). Participants were randomized on Day 1 to one of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB and CBA). There were 3 treatment periods with a total of 3 participants in each of 3 sequences (ABC, ACB, CAB) and 2 participants in each of 3 other sequences (CBA, BAC, BCA) for a total of 15 participants who participated in this open label, randomized, crossover study.
82067|NCT02074358|P6|Participant Flow|Treatment CBA|"Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID)Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Saline solution (placebo) 0 IU/kg IV infusion for 30 minutes."
82068|NCT02074358|P5|Participant Flow|Treatment CAB|"Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID)Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Saline solution (placebo) 0 IU/kg IV infusion for 30 minutes.~Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes."
82069|NCT02074358|P4|Participant Flow|Treatment BCA|"Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID)Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Saline solution (placebo) 0 IU/kg IV infusion for 30 minutes."
82070|NCT02074358|P3|Participant Flow|Treatment BAC|"Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID)Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Saline solution (placebo) 0 IU/kg IV infusion for 30 minutes.~Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes."
82071|NCT02074358|P2|Participant Flow|Treatment ACB|"Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID)Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Saline solution (placebo) 0 IU/kg IV infusion for 30 minutes.~Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes."
82072|NCT02074358|P1|Participant Flow|Treatment ABC|"Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID) on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours (hrs) later by Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) intravenous infusion (IV) for 30 minutes.~Treatment B: Apixaban + Cofact [4-Factor prothrombin complex concentrate (PCC)]: Apixaban 10 mg oral Tablet BID on Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 min."
82073|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82074|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82075|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82076|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82077|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82078|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82079|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82080|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82081|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82082|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82083|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82084|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82085|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82086|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82087|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82088|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82089|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82090|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82091|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82092|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82093|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82094|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82095|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82096|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82097|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82098|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82099|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82100|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82101|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82102|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82103|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82104|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82105|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82106|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82107|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82108|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82109|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82110|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82111|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82112|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82197|NCT02074059|O4|Outcome|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
82113|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82114|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82115|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82116|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82117|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82118|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82119|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82120|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82121|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82122|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82123|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82124|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82125|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82126|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82127|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82128|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82129|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82130|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82131|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82132|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82133|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82134|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82135|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82198|NCT02074059|O3|Outcome|Aerosolized Lucinactant (75 mg/kg)|75 mg TPL/kg of Lucinactant for inhalation with nCPAP
84006|NCT02061358|P4|Participant Flow|90 mg UV-4B|UV-4B 90 mg oral, single dose
82136|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82137|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82138|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82139|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82140|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82141|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82142|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82143|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82144|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82145|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82146|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82147|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82148|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82149|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82150|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82151|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82152|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82153|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82154|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82155|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82156|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82157|NCT02074358|E3|Reported Event|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
82158|NCT02074358|E2|Reported Event|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
82199|NCT02074059|O2|Outcome|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of Lucinactant for inhalation with nCPAP
84007|NCT02061358|P3|Participant Flow|30 mg UV-4B|UV-4B 30 mg oral, single dose
82159|NCT02074358|E1|Reported Event|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
82160|NCT02074345|B1|Baseline|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
82161|NCT02074345|P1|Participant Flow|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
82162|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
82163|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
82164|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
82165|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
82166|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
82167|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
82168|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
82169|NCT02074345|E1|Reported Event|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
82170|NCT02074059|B7|Baseline|Total|Total of all reporting groups
82171|NCT02074059|B6|Baseline|nCPAP Alone|nCPAP therapy alone
82172|NCT02074059|B5|Baseline|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of lucinactant for Inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
82173|NCT02074059|B4|Baseline|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of lucinactant for Inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
82174|NCT02074059|B3|Baseline|Aerosolized Lucinactant (75 mg/kg)|75 mg TPL/kg of lucinactant for inhalation with nCPAP
82175|NCT02074059|B2|Baseline|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of lucinactant for inhalation with nCPAP
82176|NCT02074059|B1|Baseline|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of lucinactant for inhalation with nCPAP
82177|NCT02074059|P6|Participant Flow|nCPAP Alone|"nCPAP therapy alone~nCPAP alone: nCPAP therapy"
82178|NCT02074059|P5|Participant Flow|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
82179|NCT02074059|P4|Participant Flow|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
82180|NCT02074059|P3|Participant Flow|Aerosolized Lucinactant (75 mg/kg)|75 mg TPL/kg of Lucinactant for inhalation with nCPAP
82181|NCT02074059|P2|Participant Flow|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of Lucinactant for inhalation with nCPAP
82182|NCT02074059|P1|Participant Flow|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of Lucinactant for inhalation with nCPAP
82183|NCT02074059|O6|Outcome|nCPAP Alone|nCPAP therapy alone
82184|NCT02074059|O5|Outcome|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
82185|NCT02074059|O4|Outcome|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
82186|NCT02074059|O3|Outcome|Aerosolized Lucinactant (75 mg/kg)|75 mg TPL/kg of Lucinactant for inhalation with nCPAP
82187|NCT02074059|O2|Outcome|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of Lucinactant for inhalation with nCPAP
82188|NCT02074059|O1|Outcome|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of Lucinactant for inhalation with nCPAP
82189|NCT02074059|O6|Outcome|nCPAP Alone|nCPAP therapy alone
82190|NCT02074059|O5|Outcome|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
82191|NCT02074059|O4|Outcome|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
82192|NCT02074059|O3|Outcome|Aerosolized Lucinactant (High Dose)|75 mg TPL/kg of Lucinactant for inhalation with nCPAP
82193|NCT02074059|O2|Outcome|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of Lucinactant for inhalation with nCPAP
82194|NCT02074059|O1|Outcome|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of Lucinactant for inhalation with nCPAP
82195|NCT02074059|O6|Outcome|nCPAP Alone|nCPAP therapy alone
82196|NCT02074059|O5|Outcome|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
82200|NCT02074059|O1|Outcome|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of Lucinactant for inhalation with nCPAP
82202|NCT02074059|O5|Outcome|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
82203|NCT02074059|O4|Outcome|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
82204|NCT02074059|O3|Outcome|Aerosolized Lucinactant (75 mg/kg)|75 mg TPL/kg of Lucinactant for inhalation with nCPAP
82205|NCT02074059|O2|Outcome|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of Lucinactant for inhalation with nCPAP
82206|NCT02074059|O1|Outcome|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of Lucinactant for inhalation with nCPAP
82207|NCT02074059|O6|Outcome|nCPAP Alone|nCPAP therapy alone
82208|NCT02074059|O5|Outcome|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
82209|NCT02074059|O4|Outcome|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
82210|NCT02074059|O3|Outcome|Aerosolized Lucinactant (75 mg/kg)|75 mg TPL/kg of Lucinactant for inhalation with nCPAP
82211|NCT02074059|O2|Outcome|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of Lucinactant for inhalation with nCPAP
82212|NCT02074059|O1|Outcome|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of Lucinactant for inhalation with nCPAP
82213|NCT02074059|E6|Reported Event|nCPAP Alone|nCPAP therapy alone
82214|NCT02074059|E5|Reported Event|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
82215|NCT02074059|E4|Reported Event|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
82216|NCT02074059|E3|Reported Event|Aerosolized Lucinactant (75 mg/kg)|75 mg TPL/kg of Lucinactant for inhalation with nCPAP
82217|NCT02074059|E2|Reported Event|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of Lucinactant for inhalation with nCPAP
82218|NCT02074059|E1|Reported Event|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of Lucinactant for inhalation with nCPAP
82219|NCT02073747|B3|Baseline|Total|Total of all reporting groups
82220|NCT02073747|B2|Baseline|Normal Saline|Control group
82221|NCT02073747|B1|Baseline|Albuterol|Study group
82222|NCT02073747|P2|Participant Flow|Albuterol Trial Group|"Trial group to be administered one hour treatment of ten milligrams of inhaled albuterol~Albuterol: One hour inhaled ten milligrams of albuterol"
82223|NCT02073747|P1|Participant Flow|Normal Saline Control Group|"Control group will be administered a one hour normal saline inhaled treatment.~Normal Saline: One hour inhaled normal saline"
82224|NCT02073747|O2|Outcome|Albuterol Trial Group|"Trial group to be administered one hour treatment of ten milligrams of inhaled albuterol~Albuterol: One hour inhaled ten milligrams of albuterol"
82225|NCT02073747|O1|Outcome|Normal Saline Control Group|"Control group will be administered a one hour normal saline inhaled treatment.~Normal Saline: One hour inhaled normal saline"
82226|NCT02073747|E2|Reported Event|Normal Saline|Control group
82227|NCT02073747|E1|Reported Event|Albuterol|Study group; 10 mg of nebulizer albuterol
82228|NCT02073656|B1|Baseline|LDV/SOF 12 Weeks|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for up to 12 weeks.
82229|NCT02073656|P1|Participant Flow|LDV/SOF 12 Weeks|"Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for up to 12 weeks.~Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 24 weeks."
82230|NCT02073656|O1|Outcome|LDV/SOF+RBV 24 Weeks (Retreatment Substudy)|Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
82231|NCT02073656|O1|Outcome|LDV/SOF+RBV 24 Weeks (Retreatment Substudy)|Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
82232|NCT02073656|O1|Outcome|LDV/SOF+RBV 24 Weeks (Retreatment Substudy)|Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
82233|NCT02073656|O1|Outcome|LDV/SOF+RBV 24 Weeks (Retreatment Substudy)|Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
82234|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
82235|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
82236|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
82237|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
82238|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
82239|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
82240|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
82241|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
82313|NCT02072928|B1|Baseline|BOTOX®|Patients with incontinence from NDO due to spinal injury or MS prescribed BOTOX® (Botulinum toxin Type A) as standard of care in clinical practice.
82631|NCT02070380|B1|Baseline|MultiHance 0.1 mmol/kg Then Dotarem 0.1 mmol/kg|Patients randomized to receive MultiHance 0.1 mmol/kg first
82242|NCT02073656|E2|Reported Event|LDV/SOF+RBV 24 Weeks (Retreatment)|Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
82243|NCT02073656|E1|Reported Event|LDV/SOF 12 Weeks (Primary Study)|LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
82244|NCT02073461|B4|Baseline|Total|Total of all reporting groups
82245|NCT02073461|B3|Baseline|Vehicle|"Vehicle~Vehicle"
82246|NCT02073461|B2|Baseline|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
82247|NCT02073461|B1|Baseline|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
82248|NCT02073461|P3|Participant Flow|Vehicle|"Vehicle~Vehicle"
82249|NCT02073461|P2|Participant Flow|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
82250|NCT02073461|P1|Participant Flow|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
82251|NCT02073461|O3|Outcome|Vehicle|"Vehicle~Vehicle"
82252|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
82253|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
82254|NCT02073461|O3|Outcome|Vehicle|"Vehicle~Vehicle"
82255|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
82256|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
82257|NCT02073461|O3|Outcome|Vehicle|"Vehicle~Vehicle"
82258|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
82259|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
82260|NCT02073461|O3|Outcome|Vehicle|"Vehicle~Vehicle"
82261|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
82262|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
82263|NCT02073461|O3|Outcome|Vehicle|"Vehicle~Vehicle"
82264|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
82265|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
82266|NCT02073461|O3|Outcome|Vehicle|"Vehicle~Vehicle"
82267|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
82268|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
82269|NCT02073461|O3|Outcome|Vehicle|"Vehicle~Vehicle"
82270|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
82271|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
82272|NCT02073461|E3|Reported Event|Vehicle|"Vehicle~Vehicle"
82273|NCT02073461|E2|Reported Event|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
82274|NCT02073461|E1|Reported Event|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
82275|NCT02073448|B4|Baseline|Total|Total of all reporting groups
82276|NCT02073448|B3|Baseline|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
82277|NCT02073448|B2|Baseline|CD0271|"Adapalene 01% Gel~CD0271"
82278|NCT02073448|B1|Baseline|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
82279|NCT02073448|P3|Participant Flow|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
82280|NCT02073448|P2|Participant Flow|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
82281|NCT02073448|P1|Participant Flow|CD0271|"Adapalene 01% Gel~CD0271"
82282|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
82283|NCT02073448|O2|Outcome|CD0271|"Adapalene 01% Gel~CD0271"
82284|NCT02073448|O1|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
82285|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
82286|NCT02073448|O2|Outcome|CD0271|"Adapalene 01% Gel~CD0271"
82287|NCT02073448|O1|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
82288|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
82289|NCT02073448|O2|Outcome|CD0271|"Adapalene 01% Gel~CD0271"
82290|NCT02073448|O1|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
82291|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
82292|NCT02073448|O2|Outcome|CD0271|"Adapalene 01% Gel~CD0271"
82293|NCT02073448|O1|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
82294|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
82295|NCT02073448|O2|Outcome|CD0271|"Adapalene 01% Gel~CD0271"
82296|NCT02073448|O1|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
82297|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
82298|NCT02073448|O2|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
82299|NCT02073448|O1|Outcome|CD0271|"Adapalene 01% Gel~CD0271"
82300|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
82301|NCT02073448|O2|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
82302|NCT02073448|O1|Outcome|CD0271|"Adapalene 01% Gel~CD0271"
82303|NCT02073448|E3|Reported Event|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
82304|NCT02073448|E2|Reported Event|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
82305|NCT02073448|E1|Reported Event|CD0271|"Adapalene 01% Gel~CD0271"
82306|NCT02072980|B1|Baseline|Overall|Delefilcon A contact lenses worn during Period 1 and Period 2
82307|NCT02072980|P2|Participant Flow|15min/16hr|Delefilcon A contact lenses worn bilaterally for 15 minutes in Period 1, follwed by 16 waking hours (1 day) in Period 2. A fresh pair of lenses was dispensed for Period 2.
82308|NCT02072980|P1|Participant Flow|16hr/15min|Delefilcon A contact lenses worn bilaterally for 16 waking hours (1 day) in Period 1, followed by 15 minutes in Period 2. A fresh pair of lenses was dispensed for Period 2.
82309|NCT02072980|O1|Outcome|15 Minutes|Delefilcon A contact lenses worn for 15 minutes during Period 1 or 2
82310|NCT02072980|O2|Outcome|Unworn|Unworn delefilcon A contact lenses removed from the commercial packaging and soaked overnight in phosphate buffered saline
82311|NCT02072980|O1|Outcome|16 Hours|Delefilcon A contact lenses worn for 16 hours in Period 1 or 2
82314|NCT02072928|P1|Participant Flow|BOTOX®|Patients with incontinence from NDO due to spinal injury or MS prescribed BOTOX® (Botulinum toxin Type A) as standard of care in clinical practice.
82315|NCT02072928|O1|Outcome|BOTOX®|Patients with incontinence from NDO due to spinal injury or MS prescribed BOTOX® (Botulinum toxin Type A) as standard of care in clinical practice.
82316|NCT02072928|E1|Reported Event|BOTOX®|Patients with incontinence from NDO due to spinal injury or MS prescribed BOTOX® (Botulinum toxin Type A) as standard of care in clinical practice.
82317|NCT02072421|B1|Baseline|PCI at Hospitals Without On-Site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
82318|NCT02072421|P1|Participant Flow|PCI at Hospitals Without On-Site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
82319|NCT02072421|O1|Outcome|PCI at a Hospital Without On-site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
82320|NCT02072421|O1|Outcome|PCI at a Hospital Without On-site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
82321|NCT02072421|O1|Outcome|PCI at a Hospital Without On-site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
82322|NCT02072421|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
82323|NCT02072421|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
82324|NCT02072421|E1|Reported Event|PCI at Hospitals Without On-Site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
82325|NCT02072200|B1|Baseline|Modified Release Prednisone|"Single arm / Lodotra~Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
82326|NCT02072200|P1|Participant Flow|Modified Release Prednisone|"Single arm / Lodotra~Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
82327|NCT02072200|O1|Outcome|Modified Release Prednisone|"Single arm / Lodotra~Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
82328|NCT02072200|O1|Outcome|Modified Release Prednisone|"Single arm / Lodotra~Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
82329|NCT02072200|O1|Outcome|Modified Release Prednisone|"Single arm / Lodotra~Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
82330|NCT02072200|E1|Reported Event|Modified Release Prednisone|"Single arm / Lodotra~Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
82331|NCT02072096|B3|Baseline|Total|Total of all reporting groups
82332|NCT02072096|B2|Baseline|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Insulin glargine dose is titrated according to treatment algorithm. Treatment may last up to 72 weeks.
82333|NCT02072096|B1|Baseline|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
82334|NCT02072096|P2|Participant Flow|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Insulin glargine is titrated according to treatment algorithm. Treatment may last up to 72 weeks.
82335|NCT02072096|P1|Participant Flow|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
82336|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
82337|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
82338|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
82339|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label.Treatment may last up to 72 weeks.
82502|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82340|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
82341|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
82342|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
82343|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label.Treatment may last up to 72 weeks.
82344|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
82345|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label.Treatment may last up to 72 weeks.
82346|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
82347|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
82348|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
82349|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
82350|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
82351|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
82352|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
82353|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
82354|NCT02072096|E2|Reported Event|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
82379|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82355|NCT02072096|E1|Reported Event|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
82356|NCT02071849|B1|Baseline|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82357|NCT02071849|P1|Participant Flow|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82358|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82359|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82360|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82361|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82362|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82363|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82364|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82365|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82366|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82367|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82368|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82369|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82370|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82371|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82372|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82373|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82374|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82375|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82376|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82377|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82378|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82701|NCT02070237|B3|Baseline|Total|Total of all reporting groups
82380|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82381|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82382|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82383|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82384|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82385|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82386|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82387|NCT02071849|E1|Reported Event|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
82388|NCT02071823|B3|Baseline|Total|Total of all reporting groups
82389|NCT02071823|B2|Baseline|Group B Fasted/Fed|"A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:~Period 1: Fasted Washout Period (7days) Period 2: Fed~BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days."
82390|NCT02071823|B1|Baseline|Group A Fed/Fasted|"A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:~Period 1: Fed Washout Period (7days) Period 2: Fasted~BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days."
82391|NCT02071823|P2|Participant Flow|Group B Fasted/Fed|"A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:~Period 1: Fasted Washout Period (7days) Period 2: Fed~BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days."
82392|NCT02071823|P1|Participant Flow|Group A Fed/Fasted|"A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:~Period 1: Fed Washout Period (7days) Period 2: Fasted~BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days."
82393|NCT02071823|O2|Outcome|Fed Condition|Fed condition period
82394|NCT02071823|O1|Outcome|Fasted Conditions|Fasted conditions period
82395|NCT02071823|O2|Outcome|Fasted Condition|Fasted condition period
82396|NCT02071823|O1|Outcome|Fed Conditions|Fed conditions period
82397|NCT02071823|O2|Outcome|Fed Condition|Fed condition period
82398|NCT02071823|O1|Outcome|Fasted Conditions|Fasted conditions period
82399|NCT02071823|E2|Reported Event|Fed Condition|Fed condition period
82400|NCT02071823|E1|Reported Event|Fasted Conditions|Fasted conditions period
82401|NCT02071810|B6|Baseline|Total|Total of all reporting groups
82402|NCT02071810|B5|Baseline|Placebo|"Placebo, PLC~Placebo"
82403|NCT02071810|B4|Baseline|BIA 9-1067 30 mg|"BIA 9-1067 (OPC, Opicapone) 30 mg~BIA 9-1067"
82404|NCT02071810|B3|Baseline|BIA 9-1067 20 mg|"BIA 9-1067 (OPC, Opicapone) 20 mg~BIA 9-1067"
82405|NCT02071810|B2|Baseline|BIA 9-1067 10 mg|"BIA 9-1067 (OPC, Opicapone) 10 mg~BIA 9-1067"
82406|NCT02071810|B1|Baseline|BIA 9-1067 5 mg|"BIA 9-1067 (OPC, Opicapone) 5 mg~BIA 9-1067"
82407|NCT02071810|P5|Participant Flow|Placebo|"Placebo, PLC~Placebo"
82408|NCT02071810|P4|Participant Flow|BIA 9-1067 30 mg|"BIA 9-1067 (OPC, Opicapone) 30 mg~BIA 9-1067"
82409|NCT02071810|P3|Participant Flow|BIA 9-1067 20 mg|"BIA 9-1067 (OPC, Opicapone) 20 mg~BIA 9-1067"
82410|NCT02071810|P2|Participant Flow|BIA 9-1067 10 mg|"BIA 9-1067 (OPC, Opicapone) 10 mg~BIA 9-1067"
82411|NCT02071810|P1|Participant Flow|BIA 9-1067 5 mg|"BIA 9-1067 (OPC, Opicapone) 5 mg~BIA 9-1067"
82412|NCT02071810|O5|Outcome|Placebo|"Placebo, PLC~Placebo"
82413|NCT02071810|O4|Outcome|BIA 9-1067 30 mg|"BIA 9-1067 (OPC, Opicapone) 30 mg~BIA 9-1067"
82414|NCT02071810|O3|Outcome|BIA 9-1067 20 mg|"BIA 9-1067 (OPC, Opicapone) 20 mg~BIA 9-1067"
82415|NCT02071810|O2|Outcome|BIA 9-1067 10 mg|"BIA 9-1067 (OPC, Opicapone) 10 mg~BIA 9-1067"
82416|NCT02071810|O1|Outcome|BIA 9-1067 5 mg|"BIA 9-1067 (OPC, Opicapone) 5 mg~BIA 9-1067"
82417|NCT02071810|E5|Reported Event|Placebo|"Placebo, PLC~Placebo"
82418|NCT02071810|E4|Reported Event|BIA 9-1067 30 mg|"BIA 9-1067 (OPC, Opicapone) 30 mg~BIA 9-1067"
82419|NCT02071810|E3|Reported Event|BIA 9-1067 20 mg|"BIA 9-1067 (OPC, Opicapone) 20 mg~BIA 9-1067"
82420|NCT02071810|E2|Reported Event|BIA 9-1067 10 mg|"BIA 9-1067 (OPC, Opicapone) 10 mg~BIA 9-1067"
82421|NCT02071810|E1|Reported Event|BIA 9-1067 5 mg|"BIA 9-1067 (OPC, Opicapone) 5 mg~BIA 9-1067"
82422|NCT02071771|B1|Baseline|Overall|Nelfilcon A and Etafilcon A toric contact lenses worn during Period 1 and Period 2, as randomized, in a crossover assignment.
82503|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82423|NCT02071771|P2|Participant Flow|1DAM A, Then DACP T|Etafilcon A toric contact lenses worn first, with Nelfilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
82424|NCT02071771|P1|Participant Flow|DACP T, Then 1DAM A|Nelfilcon A toric contact lenses worn first, with Etafilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
82425|NCT02071771|O2|Outcome|1DAM A|Etafilcon A toric contact lenses worn bilaterally during Period 1 or Period 2 on a daily wear, daily disposable basis for 10 days.
82426|NCT02071771|O1|Outcome|DACP T|Nelfilcon A toric contact lenses worn bilaterally during Period 1 or Period 2 on a daily wear, daily disposable basis for 10 days.
82427|NCT02071771|O2|Outcome|1DAM A|Etafilcon A toric contact lenses worn bilaterally during Period 1 or Period 2 on a daily wear, daily disposable basis for 10 days.
82428|NCT02071771|O1|Outcome|DACP T|Nelfilcon A toric contact lenses worn bilaterally during Period 1 or Period 2 on a daily wear, daily disposable basis for 10 days.
82429|NCT02071771|E2|Reported Event|1DAM A|Etafilcon A toric contact lenses worn bilaterally on a daily wear, daily disposable basis for 10 days.
82430|NCT02071771|E1|Reported Event|DACP T|Nelfilcon A toric contact lenses worn bilaterally on a daily wear, daily disposable basis for 10 days.
82431|NCT02071420|B3|Baseline|Total|Total of all reporting groups
82432|NCT02071420|B2|Baseline|Active Control|"This group will receive the ergonomic intervention and email intervention only for 16 weeks. This group will not receive a seated active workstation.~Ergonomic Intervention: Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.~Email Intervention: Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).~Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application."
82433|NCT02071420|B1|Baseline|Experimental Group|"This group will receive the seated active workstation intervention, the ergonomic intervention and the email intervention for 16 weeks.~Active Workstation Intervention: Participants in the experimental group will receive a seated active workstation at their work setting for 16 weeks.~Ergonomic Intervention: Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.~Email Intervention: Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).~Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application."
82434|NCT02071420|P2|Participant Flow|Active Control|"This group will receive the ergonomic intervention and email intervention only for 16 weeks. This group will not receive a seated active workstation.~Ergonomic Intervention: Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.~Email Intervention: Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).~Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application."
82435|NCT02071420|P1|Participant Flow|Experimental Group|"This group will receive the seated active workstation intervention, the ergonomic intervention and the email intervention for 16 weeks.~Active Workstation Intervention: Participants in the experimental group will receive a seated active workstation at their work setting for 16 weeks.~Ergonomic Intervention: Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.~Email Intervention: Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).~Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application."
82436|NCT02071420|O2|Outcome|Active Control|"This group will receive the ergonomic intervention and email intervention only for 16 weeks. This group will not receive a seated active workstation.~Ergonomic Intervention: Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.~Email Intervention: Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).~Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application."
82437|NCT02071420|O1|Outcome|Experimental Group|"This group will receive the seated active workstation intervention, the ergonomic intervention and the email intervention for 16 weeks.~Active Workstation Intervention: Participants in the experimental group will receive a seated active workstation at their work setting for 16 weeks.~Ergonomic Intervention: Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.~Email Intervention: Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).~Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application."
82469|NCT02071095|O1|Outcome|Arm A: Poly-ICLC|Poly-ICLC: Poly-ICLC (Hiltonol®, Oncovir) Administration - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with 1.4 mg of Poly-ICLC (Hiltonol®, Oncovir). Each subject will receive a total of 2 SC doses of Poly-ICLC. The volume of each injection is 0.7ml.
82470|NCT02071095|O2|Outcome|Arm B: Normal Saline|Normal Saline: Normal Saline - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with normal saline obtained from the Rockefeller University Pharmacy. Each subject will receive a total of 2 SC doses of normal saline. The volume of each injection is 0.7ml.
82438|NCT02071420|E2|Reported Event|Active Control|"This group will receive the ergonomic intervention and email intervention only for 16 weeks. This group will not receive a seated active workstation.~Ergonomic Intervention: Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.~Email Intervention: Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).~Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application."
82439|NCT02071420|E1|Reported Event|Experimental Group|"This group will receive the seated active workstation intervention, the ergonomic intervention and the email intervention for 16 weeks.~Active Workstation Intervention: Participants in the experimental group will receive a seated active workstation at their work setting for 16 weeks.~Ergonomic Intervention: Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.~Email Intervention: Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).~Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application."
82440|NCT02071108|B1|Baseline|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
82441|NCT02071108|P1|Participant Flow|Lithoplasty Treatment|All subjects were treated with the Shockwave Medical Peripheral Lithoplasty System
82442|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
82443|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
82444|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
82445|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
82446|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
82447|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
82448|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
82449|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
82450|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
82451|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
82452|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
82453|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
82454|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
82455|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
82456|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
82457|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
82458|NCT02071108|E1|Reported Event|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
82459|NCT02071095|B3|Baseline|Total|Total of all reporting groups
82460|NCT02071095|B2|Baseline|Arm B: Normal Saline|Normal Saline: Normal Saline - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with normal saline obtained from the Rockefeller University Pharmacy. Each subject will receive a total of 2 SC doses of normal saline. The volume of each injection is 0.7ml.
82461|NCT02071095|B1|Baseline|Arm A: Poly-ICLC|Poly-ICLC: Poly-ICLC (Hiltonol®, Oncovir) Administration - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with 1.4 mg of Poly-ICLC (Hiltonol®, Oncovir). Each subject will receive a total of 2 SC doses of Poly-ICLC. The volume of each injection is 0.7ml.
82462|NCT02071095|P2|Participant Flow|Arm B: Normal Saline|Normal Saline: Normal Saline - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with normal saline obtained from the Rockefeller University Pharmacy. Each subject will receive a total of 2 SC doses of normal saline. The volume of each injection is 0.7ml.
82463|NCT02071095|P1|Participant Flow|Arm A: Poly-ICLC|Poly-ICLC: Poly-ICLC (Hiltonol®, Oncovir) Administration - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with 1.4 mg of Poly-ICLC (Hiltonol®, Oncovir). Each subject will receive a total of 2 SC doses of Poly-ICLC. The volume of each injection is 0.7ml.
82464|NCT02071095|O2|Outcome|Arm B: Normal Saline|Normal Saline: Normal Saline - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with normal saline obtained from the Rockefeller University Pharmacy. Each subject will receive a total of 2 SC doses of normal saline. The volume of each injection is 0.7ml.
82465|NCT02071095|O1|Outcome|Arm A: Poly-ICLC|Poly-ICLC: Poly-ICLC (Hiltonol®, Oncovir) Administration - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with 1.4 mg of Poly-ICLC (Hiltonol®, Oncovir). Each subject will receive a total of 2 SC doses of Poly-ICLC. The volume of each injection is 0.7ml.
82466|NCT02071095|O2|Outcome|Arm B: Normal Saline|Normal Saline: Normal Saline - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with normal saline obtained from the Rockefeller University Pharmacy. Each subject will receive a total of 2 SC doses of normal saline. The volume of each injection is 0.7ml.
82467|NCT02071095|O1|Outcome|Arm A: Poly-ICLC|Poly-ICLC: Poly-ICLC (Hiltonol®, Oncovir) Administration - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with 1.4 mg of Poly-ICLC (Hiltonol®, Oncovir). Each subject will receive a total of 2 SC doses of Poly-ICLC. The volume of each injection is 0.7ml.
82468|NCT02071095|O2|Outcome|Arm B: Normal Saline|Normal Saline: Normal Saline - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with normal saline obtained from the Rockefeller University Pharmacy. Each subject will receive a total of 2 SC doses of normal saline. The volume of each injection is 0.7ml.
82547|NCT02070744|O1|Outcome|PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h|Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
82471|NCT02071095|O1|Outcome|Arm A: Poly-ICLC|Poly-ICLC: Poly-ICLC (Hiltonol®, Oncovir) Administration - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with 1.4 mg of Poly-ICLC (Hiltonol®, Oncovir). Each subject will receive a total of 2 SC doses of Poly-ICLC. The volume of each injection is 0.7ml.
82472|NCT02071095|O2|Outcome|Arm B: Normal Saline|Normal Saline: Normal Saline - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with normal saline obtained from the Rockefeller University Pharmacy. Each subject will receive a total of 2 SC doses of normal saline. The volume of each injection is 0.7ml.
82473|NCT02071095|O1|Outcome|Arm A: Poly-ICLC|Poly-ICLC: Poly-ICLC (Hiltonol®, Oncovir) Administration - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with 1.4 mg of Poly-ICLC (Hiltonol®, Oncovir). Each subject will receive a total of 2 SC doses of Poly-ICLC. The volume of each injection is 0.7ml.
82474|NCT02071095|E2|Reported Event|Arm B: Normal Saline|Normal Saline: Normal Saline - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with normal saline obtained from the Rockefeller University Pharmacy. Each subject will receive a total of 2 SC doses of normal saline. The volume of each injection is 0.7ml.
82475|NCT02071095|E1|Reported Event|Arm A: Poly-ICLC|Poly-ICLC: Poly-ICLC (Hiltonol®, Oncovir) Administration - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with 1.4 mg of Poly-ICLC (Hiltonol®, Oncovir). Each subject will receive a total of 2 SC doses of Poly-ICLC. The volume of each injection is 0.7ml.
82476|NCT02071082|B3|Baseline|Total|Total of all reporting groups
82477|NCT02071082|B2|Baseline|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82478|NCT02071082|B1|Baseline|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82479|NCT02071082|P2|Participant Flow|HIV-Suppressed (Cohort 2)|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82480|NCT02071082|P1|Participant Flow|HIV/HBV Treatment-Naive (Cohort 1)|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 48 weeks.
82481|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82482|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82483|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82484|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82485|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82486|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82487|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82488|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82489|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82490|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82491|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82492|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82493|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82494|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82495|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82496|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82497|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82498|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82499|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82500|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82501|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82504|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
82505|NCT02071082|E2|Reported Event|HIV-Suppressed|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 48 weeks (HIV-suppressed)
82506|NCT02071082|E1|Reported Event|HIV/HBV Treatment-Naive|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 48 weeks (HIV treatment-naive and HBV treatment-naive)
82507|NCT02070965|B4|Baseline|Total|Total of all reporting groups
82508|NCT02070965|B3|Baseline|DFD01 Spray Group 2|"DFD01 Spray, bid, 14 days~DFD01 Spray"
82509|NCT02070965|B2|Baseline|Comp01 Lotion|"Comp01 Lotion, bid, 14 days~Comp01 Lotion"
82510|NCT02070965|B1|Baseline|DFD01 Spray Group 1|"DFD01 Spray, bid, 28 days~DFD01 Spray"
82511|NCT02070965|P3|Participant Flow|DFD01 Spray Group 2|"DFD01 Spray, bid, 14 days~DFD01 Spray"
82512|NCT02070965|P2|Participant Flow|Comp01 Lotion|"Comp01 Lotion, bid, 14 days~Comp01 Lotion"
82513|NCT02070965|P1|Participant Flow|DFD01 Spray Group 1|"DFD01 Spray, bid, 28 days~DFD01 Spray"
82514|NCT02070965|O3|Outcome|DFD01 Spray Group 2|"DFD01 Spray, bid, 14 days~DFD01 Spray"
82515|NCT02070965|O2|Outcome|Comp01 Lotion|"Comp01 Lotion, bid, 14 days~Comp01 Lotion"
82516|NCT02070965|O1|Outcome|DFD01 Spray Group 1|"DFD01 Spray, bid, 28 days~DFD01 Spray"
82517|NCT02070965|E3|Reported Event|DFD01 Spray Group 2|"DFD01 Spray, bid, 14 days~DFD01 Spray"
82518|NCT02070965|E2|Reported Event|Comp01 Lotion|"Comp01 Lotion, bid, 14 days~Comp01 Lotion"
82519|NCT02070965|E1|Reported Event|DFD01 Spray Group 1|"DFD01 Spray, bid, 28 days~DFD01 Spray"
82520|NCT02070744|B5|Baseline|Total|Total of all reporting groups
82521|NCT02070744|B4|Baseline|PC Phase: VX -661 Placebo qd + IVA Placebo q12h|Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
82522|NCT02070744|B3|Baseline|PC Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
82523|NCT02070744|B2|Baseline|PC Phase: VX-661 Placebo q12h + IVA Placebo q12h|Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
82524|NCT02070744|B1|Baseline|PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h|Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
82525|NCT02070744|P5|Participant Flow|OLE Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants who completed 12 week PC phase underwent a washout period of at least 4 weeks before entering the OLE phase and received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 48 weeks in OLE phase.
82526|NCT02070744|P4|Participant Flow|PC Phase: VX -661 Placebo qd + IVA Placebo q12h|Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
82527|NCT02070744|P3|Participant Flow|PC Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants received two VX-661 50 mg tablets once daily (qd) plus IVA 150 mg tablet q12h for 12 weeks.
82528|NCT02070744|P2|Participant Flow|PC Phase: VX-661 Placebo q12h + IVA Placebo q12h|Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
82529|NCT02070744|P1|Participant Flow|PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h|Participants received VX-661 50 milligram (mg) tablet plus IVA 150 mg tablet every 12 hours (q12h) for 12 weeks.
82530|NCT02070744|O2|Outcome|PC Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
82531|NCT02070744|O1|Outcome|PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h|Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
82532|NCT02070744|O2|Outcome|PC Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
82533|NCT02070744|O1|Outcome|PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h|Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
82534|NCT02070744|O2|Outcome|PC Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
82535|NCT02070744|O1|Outcome|PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h|Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
82536|NCT02070744|O2|Outcome|PC Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
82537|NCT02070744|O1|Outcome|PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h|Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
82538|NCT02070744|O1|Outcome|OLE Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants who completed 12 week PC phase underwent a washout period of at least 4 weeks before entering the OLE phase and received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 48 weeks in OLE phase.
82539|NCT02070744|O4|Outcome|PC Phase: VX -661 Placebo qd + IVA Placebo q12h|Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
82540|NCT02070744|O3|Outcome|PC Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
82541|NCT02070744|O2|Outcome|PC Phase: VX-661 Placebo q12h + IVA Placebo q12h|Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
82542|NCT02070744|O1|Outcome|PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h|Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
82543|NCT02070744|O1|Outcome|OLE Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants who completed 12 week PC phase underwent a washout period of at least 4 weeks before entering the OLE phase and received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 48 weeks in OLE phase.
82544|NCT02070744|O4|Outcome|PC Phase: VX -661 Placebo qd + IVA Placebo q12h|Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
82545|NCT02070744|O3|Outcome|PC Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
82546|NCT02070744|O2|Outcome|PC Phase: VX-661 Placebo q12h + IVA Placebo q12h|Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
82787|NCT02068027|B2|Baseline|Placebo|"Placebo gel of identical appearance as active treatment~Placebo"
82548|NCT02070744|O1|Outcome|OLE Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants who completed 12 week PC phase underwent a washout period of at least 4 weeks before entering the OLE phase and received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 48 weeks in OLE phase.
82549|NCT02070744|O4|Outcome|PC Phase: VX -661 Placebo qd + IVA Placebo q12h|Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
82550|NCT02070744|O3|Outcome|PC Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
82551|NCT02070744|O2|Outcome|PC Phase: VX-661 Placebo q12h + IVA Placebo q12h|Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
82552|NCT02070744|O1|Outcome|PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h|Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
82553|NCT02070744|O1|Outcome|OLE Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants who completed 12 week PC phase underwent a washout period of at least 4 weeks before entering the OLE phase and received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 48 weeks in OLE phase.
82554|NCT02070744|O4|Outcome|PC Phase: VX -661 Placebo qd + IVA Placebo q12h|Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
82555|NCT02070744|O3|Outcome|PC Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
82556|NCT02070744|O2|Outcome|PC Phase: VX-661 Placebo q12h + IVA Placebo q12h|Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
82557|NCT02070744|O1|Outcome|PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h|Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
82558|NCT02070744|O1|Outcome|OLE Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants who completed 12 week PC phase underwent a washout period of at least 4 weeks before entering the OLE phase and received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 48 weeks in OLE phase.
82559|NCT02070744|O4|Outcome|PC Phase: VX -661 Placebo qd + IVA Placebo q12h|Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
82560|NCT02070744|O3|Outcome|PC Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
82561|NCT02070744|O2|Outcome|PC Phase: VX-661 Placebo q12h + IVA Placebo q12h|Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
82562|NCT02070744|O1|Outcome|PC Phase: VX-661 50 mg + IVA 150 mg|Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
82563|NCT02070744|O1|Outcome|OLE Phase:VX-661 100 mg qd + IVA 150 mg q12h|Participants who completed 12 week PC phase underwent a washout period of at least 4 weeks before entering the OLE phase and received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 48 weeks in OLE phase.
82564|NCT02070744|O4|Outcome|PC Phase: VX -661 Placebo qd + IVA Placebo q12h|Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
82565|NCT02070744|O3|Outcome|PC Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
82566|NCT02070744|O2|Outcome|PC Phase: VX-661 Placebo q12h + IVA Placebo q12h|Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
82567|NCT02070744|O1|Outcome|PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h|Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
82568|NCT02070744|O1|Outcome|OLE Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants who completed 12 week PC phase underwent a washout period of at least 4 weeks before entering the OLE phase and received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 48 weeks in OLE phase.
82569|NCT02070744|O4|Outcome|PC Phase: VX -661 Placebo qd + IVA Placebo q12h|Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
82570|NCT02070744|O3|Outcome|PC Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
82571|NCT02070744|O2|Outcome|PC Phase: VX-661 Placebo q12h + IVA Placebo q12h|Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
82572|NCT02070744|O1|Outcome|PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h|Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
82573|NCT02070744|E5|Reported Event|OLE Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants who completed 12 week PC phase underwent a washout period of at least 4 weeks before entering the OLE phase and received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 48 weeks in OLE phase.
82574|NCT02070744|E4|Reported Event|PC Phase: VX -661 Placebo qd + IVA Placebo q12h|Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
82575|NCT02070744|E3|Reported Event|PC Phase: VX-661 100 mg qd + IVA 150 mg q12h|Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
82576|NCT02070744|E2|Reported Event|PC Phase: VX 661 Placebo q12h + IVA Placebo q12h|Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
82577|NCT02070744|E1|Reported Event|PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h|Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
82578|NCT02070692|B3|Baseline|Total|Total of all reporting groups
82579|NCT02070692|B2|Baseline|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.~Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
82580|NCT02070692|B1|Baseline|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.~Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
82581|NCT02070692|P2|Participant Flow|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.~Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
82626|NCT02070588|E1|Reported Event|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
82582|NCT02070692|P1|Participant Flow|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.~Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
82583|NCT02070692|O2|Outcome|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.~Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
82584|NCT02070692|O1|Outcome|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.~Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
82585|NCT02070692|O2|Outcome|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.~Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
82586|NCT02070692|O1|Outcome|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.~Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
82587|NCT02070692|O2|Outcome|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.~Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
82588|NCT02070692|O1|Outcome|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.~Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
82589|NCT02070692|O2|Outcome|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.~Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
82590|NCT02070692|O1|Outcome|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.~Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
82591|NCT02070692|O2|Outcome|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.~Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
82592|NCT02070692|O1|Outcome|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.~Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
82593|NCT02070692|E2|Reported Event|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.~Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
82594|NCT02070692|E1|Reported Event|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.~Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
82595|NCT02070640|B3|Baseline|Total|Total of all reporting groups
82596|NCT02070640|B2|Baseline|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
82597|NCT02070640|B1|Baseline|Non-Acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
82598|NCT02070640|P2|Participant Flow|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
82599|NCT02070640|P1|Participant Flow|Non-acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
82600|NCT02070640|O2|Outcome|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
82601|NCT02070640|O1|Outcome|Non-acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
82627|NCT02070380|B5|Baseline|Total|Total of all reporting groups
82628|NCT02070380|B4|Baseline|Dotarem 0.1 mmol/kg Then MultiHance 0.05 mmol/kg|Patients randomized to receive Dotarem 0.1 mmol/kg first
84008|NCT02061358|P2|Participant Flow|10 mg UV-4B|UV-4B 10 mg oral, single dose
82602|NCT02070640|O2|Outcome|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
82603|NCT02070640|O1|Outcome|Non-Acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
82604|NCT02070640|O2|Outcome|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
82605|NCT02070640|O1|Outcome|Non-Acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
82606|NCT02070640|E2|Reported Event|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
82607|NCT02070640|E1|Reported Event|Non-acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
82608|NCT02070588|B4|Baseline|Total|Total of all reporting groups
82609|NCT02070588|B3|Baseline|Volunteers|"MRI Diagnostic of Volunteer Controls for Device Calibration~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
82610|NCT02070588|B2|Baseline|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
82611|NCT02070588|B1|Baseline|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
82612|NCT02070588|P3|Participant Flow|Volunteers|"MRI Diagnostic of Volunteer Controls for Device Calibration~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
82613|NCT02070588|P2|Participant Flow|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
82614|NCT02070588|P1|Participant Flow|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
82615|NCT02070588|O3|Outcome|Volunteers|"MRI Diagnostic of Volunteer Controls for Device Calibration~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
82616|NCT02070588|O2|Outcome|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
82617|NCT02070588|O1|Outcome|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
82618|NCT02070588|O3|Outcome|Volunteers|"MRI Diagnostic of Volunteer Controls for Device Calibration~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
82619|NCT02070588|O2|Outcome|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
82620|NCT02070588|O1|Outcome|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
82621|NCT02070588|O3|Outcome|Volunteers|"MRI Diagnostic of Volunteer Controls for Device Calibration~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
82622|NCT02070588|O2|Outcome|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
82623|NCT02070588|O1|Outcome|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
82624|NCT02070588|E3|Reported Event|Volunteers|"MRI Diagnostic of Volunteer Controls for Device Calibration~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
82625|NCT02070588|E2|Reported Event|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI~MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
82629|NCT02070380|B3|Baseline|MultiHance 0.05 mmol/kg Then Dotarem 0.1 mmol/kg|Patients randomized to receive MultiHance 0.05 mmol/kg first
82632|NCT02070380|P4|Participant Flow|Dotarem 0.1 mmol/kg Then MultiHance 0.05 mmol/kg|Patients randomized to receive Dotarem 0.1 mmol/kg first
82633|NCT02070380|P3|Participant Flow|MultiHance 0.05 mmol/kg Then Dotarem 0.1 mmol/kg|Patients randomized to receive MultiHance 0.05 mmol/kg first
82634|NCT02070380|P2|Participant Flow|Dotarem 0.1 mmol/kg Then MultiHance 0.1 mmol/kg|Patients randomized to receive Dotarem 0.1 mmol/kg first
82635|NCT02070380|P1|Participant Flow|MultiHance 0.1 mmol/kg Then Dotarem 0.1 mmol/kg|Patients randomized to receive MultiHance 0.1 mmol/kg first
82636|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82637|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82638|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82639|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82640|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82641|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82642|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82643|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82644|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82645|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82646|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82647|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82648|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82649|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82650|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82651|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82652|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82653|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82654|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82655|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82656|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82657|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82658|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82659|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82660|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82661|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82662|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82663|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82664|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82665|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82666|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82667|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82668|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82669|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82670|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82671|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82672|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82673|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82674|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82675|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82676|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82677|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
82678|NCT02070380|E4|Reported Event|Study Arm 2 / Dotarem 0.1 mmol/kg|"Study Arm 2: MultiHance 0.05 mmol/kg/ Experienced after dosed with Dotarem 0.1 mmol/kg.~54 (Dotarem as 1st injection) + 51 (Dotarem as 2nd injection) =105"
82679|NCT02070380|E3|Reported Event|Study Arm 2/ MultiHance 0.05 mmol/kg|"Study Arm 2: MultiHance 0.05 mmol/kg/ Experienced after dosed with MultiHance 0.05 mmol/kg.~53 (MH as 1st injection) + 51 (MH as 2nd injection) = 104"
82680|NCT02070380|E2|Reported Event|Study Arm 1 / Dotarem 0.1 mmol/kg|"Study Arm 1: MultiHance 0.1 mmol/kg/ Experienced after dosed with Dotarem 0.1 mmol/kg.~39 (Dotarem as 1st injection) + 31 (Dotarem as 2nd injection) =70"
82681|NCT02070380|E1|Reported Event|Study Arm 1 / MultiHance 0.1 mmol/kg|"Study Arm 1: MultiHance 0.1 mmol/kg/ Experienced after dosed with MultiHance 0.1 mmol/kg.~31 (MH as 1st injection) + 34 (MH as 2nd injection) = 65"
82682|NCT02070302|B3|Baseline|Total|Total of all reporting groups
82683|NCT02070302|B2|Baseline|Placebo|A prospective, randomized, double blind pilot study of 10 patients with bilateral mild to moderate CTS, diagnosed by nerve conduction studies (NCS) and NMUS (with crosssectional area measurements; and percentage of nerve compression measured during mechanical stress testing). Non-dominant hands were injected under ultrasound guidance with 40 units of 40 units of normal saline (0.4cc) divided equally into the abductor pollicis brevis and opponens pollicis muscles. Participants were evaluated with NMUS, NCS, Levine Scale (symptom severity and functional status), and Jamar dynamometer at baseline, 6, 12, and 18 weeks.
82684|NCT02070302|B1|Baseline|Botulinum Toxin Type A (Onabot)|A prospective, randomized, double blind pilot study of patients with bilateral mild to moderate CTS, diagnosed by nerve conduction studies (NCS) and NMUS (with crosssectional area measurements; and percentage of nerve compression measured during mechanical stress testing). For 5 out of 10 subjects, non-dominant hands were injected under ultrasound guidance with 40 units of Onabot (0.4cc) divided equally into the abductor pollicis brevis and opponens pollicis muscles. Participants were evaluated with NMUS, NCS, Levine Scale (symptom severity and functional status), and Jamar dynamometer at baseline, 6, 12, and 18 weeks.
82685|NCT02070302|P2|Participant Flow|Placebo|".4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)~Placebo: Placebo (Normal Saline) divided into 2 injections of .4cc each"
82686|NCT02070302|P1|Participant Flow|Botulinum Toxin Type A|"After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)~Botulinum Toxin Type A: 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each"
82687|NCT02070302|O2|Outcome|Placebo|".4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)~Placebo: Placebo (Normal Saline) divided into 2 injections of .4cc each"
82688|NCT02070302|O1|Outcome|Botulinum Toxin Type A|"After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)~Botulinum Toxin Type A: 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each"
82689|NCT02070302|O2|Outcome|Placebo|".4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)~Placebo: Placebo (Normal Saline) divided into 2 injections of .4cc each"
82690|NCT02070302|O1|Outcome|Botulinum Toxin Type A|"After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)~Botulinum Toxin Type A: 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each"
82691|NCT02070302|O2|Outcome|Placebo|".4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)~Placebo: Placebo (Normal Saline) divided into 2 injections of .4cc each"
82692|NCT02070302|O1|Outcome|Botulinum Toxin Type A|"After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)~Botulinum Toxin Type A: 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each"
82693|NCT02070302|O2|Outcome|Placebo|".4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)~Placebo: Placebo (Normal Saline) divided into 2 injections of .4cc each"
82694|NCT02070302|O1|Outcome|Botulinum Toxin Type A|"After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)~Botulinum Toxin Type A: 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each"
82695|NCT02070302|O2|Outcome|Placebo|".4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)~Placebo: Placebo (Normal Saline) divided into 2 injections of .4cc each"
82696|NCT02070302|O1|Outcome|Botulinum Toxin Type A|"After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)~Botulinum Toxin Type A: 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each"
82697|NCT02070302|O2|Outcome|Placebo|".4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)~Placebo: Placebo (Normal Saline) divided into 2 injections of .4cc each"
82698|NCT02070302|O1|Outcome|Botulinum Toxin Type A|"After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)~Botulinum Toxin Type A: 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each"
82699|NCT02070302|E2|Reported Event|Placebo|".4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)~Placebo: Placebo (Normal Saline) divided into 2 injections of .4cc each"
82700|NCT02070302|E1|Reported Event|Botulinum Toxin Type A|At 18 weeks, mean distal motor latency changes of -0.6 ms (P-value = 0.078) in the Onabot group were noted; and distal sensory latency changes of -0.3ms in the Onabot group; less slowing. Decreased mean cross-sectional area of -2.2 mm2 (P-value =0.040) in Onabot group were noted; less nerve edema. Decreased percent compression of the median nerve during stress testing was -12.6% in Onabot group. Three subjects injected with Onabot demonstrated decreases in median distal motor latencies that were nearly significant (p-value<.1, >.05), Two had decreases in median distal sensory latencies, and some had decreases in cross-sectional area on NMUS that were nearly significant. One Onabot subject did not show improvement or changes in median distal latencies but remained stable while the non-injected hand worsened with increasing median distal latencies.
82702|NCT02070237|B2|Baseline|Enoxaparin Twice Daily|"This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
82703|NCT02070237|B1|Baseline|Enoxaparin Once Daily|"This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
82704|NCT02070237|P2|Participant Flow|Enoxaparin Twice Daily|"This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
82705|NCT02070237|P1|Participant Flow|Enoxaparin Once Daily|"This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
82706|NCT02070237|O2|Outcome|Enoxaparin Twice Daily|"This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
82707|NCT02070237|O1|Outcome|Enoxaparin Once Daily|"This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
82708|NCT02070237|O2|Outcome|Enoxaparin Twice Daily|"This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
82709|NCT02070237|O1|Outcome|Enoxaparin Once Daily|"This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
82710|NCT02070237|E2|Reported Event|Enoxaparin Twice Daily|"This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
82711|NCT02070237|E1|Reported Event|Enoxaparin Once Daily|"This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
82712|NCT02069093|B1|Baseline|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
82713|NCT02069093|P1|Participant Flow|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
82714|NCT02069093|O1|Outcome|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
82715|NCT02069093|O1|Outcome|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
82788|NCT02068027|B1|Baseline|Clonidine Gel 0.1%|"Clonidine hydrochloride topical gel, 0.1%~Clonidine Gel 0.1%"
84009|NCT02061358|P1|Participant Flow|3 mg UV-4B|UV-4B 3 mg oral, single dose
82716|NCT02069093|O1|Outcome|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
82717|NCT02069093|O1|Outcome|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
82718|NCT02069093|O1|Outcome|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
82719|NCT02069093|O1|Outcome|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
82720|NCT02069093|E1|Reported Event|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
82721|NCT02068547|B3|Baseline|Total|Total of all reporting groups
82722|NCT02068547|B2|Baseline|Group 2|"Group II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration.~Bone Marrow Aspirate"
82723|NCT02068547|B1|Baseline|Surigical Best Practice|"Group 1 will receive current best practice for posterior instrumented fusion (locally harvested autograft, demineralized bone matrix, and cadaveric allograft)~locally harvested autograft, demineralized bone matrix, and cadaveric allograft"
82724|NCT02068547|P2|Participant Flow|Autograft/BMAC|"Group II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration.~Bone Marrow Aspirate"
82725|NCT02068547|P1|Participant Flow|Autograft/DBM/Cadaver Allo|"Group 1 will receive current best practice for posterior instrumented fusion (locally harvested autograft, demineralized bone matrix, and cadaveric allograft)~locally harvested autograft, demineralized bone matrix, and cadaveric allograft"
82726|NCT02068547|O2|Outcome|Group 2|"Group II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration.~Bone Marrow Aspirate"
82727|NCT02068547|O1|Outcome|Surigical Best Practice|"Group 1 will receive current best practice for posterior instrumented fusion (locally harvested autograft, demineralized bone matrix, and cadaveric allograft)~locally harvested autograft, demineralized bone matrix, and cadaveric allograft"
82728|NCT02068547|O2|Outcome|Group 2|"Group II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration.~Bone Marrow Aspirate"
82729|NCT02068547|O1|Outcome|Surigical Best Practice|"Group 1 will receive current best practice for posterior instrumented fusion (locally harvested autograft, demineralized bone matrix, and cadaveric allograft)~locally harvested autograft, demineralized bone matrix, and cadaveric allograft"
82730|NCT02068547|O2|Outcome|Group 2|"Group II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration.~Bone Marrow Aspirate"
82731|NCT02068547|O1|Outcome|Surigical Best Practice|"Group 1 will receive current best practice for posterior instrumented fusion (locally harvested autograft, demineralized bone matrix, and cadaveric allograft)~locally harvested autograft, demineralized bone matrix, and cadaveric allograft"
82732|NCT02068547|E2|Reported Event|Group 2|"Group II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration.~Bone Marrow Aspirate"
82733|NCT02068547|E1|Reported Event|Surigical Best Practice|"Group 1 will receive current best practice for posterior instrumented fusion (locally harvested autograft, demineralized bone matrix, and cadaveric allograft)~locally harvested autograft, demineralized bone matrix, and cadaveric allograft"
82734|NCT02068443|B4|Baseline|Total|Total of all reporting groups
82735|NCT02068443|B3|Baseline|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
82736|NCT02068443|B2|Baseline|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
82737|NCT02068443|B1|Baseline|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
82738|NCT02068443|P3|Participant Flow|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
82739|NCT02068443|P2|Participant Flow|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
82740|NCT02068443|P1|Participant Flow|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
82789|NCT02068027|P2|Participant Flow|Placebo|"Placebo gel of identical appearance as active treatment~Placebo"
82790|NCT02068027|P1|Participant Flow|Clonidine Gel 0.1%|"Clonidine hydrochloride topical gel, 0.1%~Clonidine Gel 0.1%"
82741|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
82742|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
82743|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
82744|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
82745|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
82746|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
82747|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
82748|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
82749|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
82750|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
82751|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
82752|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
82753|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
82754|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
82755|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
82756|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
82757|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
82758|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
82759|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
82760|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
82761|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
82762|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
82791|NCT02068027|O2|Outcome|Placebo|"Placebo gel of identical appearance as active treatment~Placebo"
82792|NCT02068027|O1|Outcome|Clonidine Gel 0.1%|"Clonidine hydrochloride topical gel, 0.1%~Clonidine Gel 0.1%"
82763|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
82764|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
82765|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
82766|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
82767|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
82768|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
82769|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
82770|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
82771|NCT02068443|E3|Reported Event|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
82772|NCT02068443|E2|Reported Event|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
82773|NCT02068443|E1|Reported Event|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
82774|NCT02068222|B1|Baseline|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.~ABT-450/ritonavir (r): Tablet~ABT-530: Tablet~Ribavirin (RBV): Tablet"
82775|NCT02068222|P1|Participant Flow|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.~ABT-450/ritonavir (r): Tablet~ABT-530: Tablet~Ribavirin (RBV): Tablet"
82776|NCT02068222|O1|Outcome|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.~ABT-450/ritonavir (r): Tablet~ABT-530: Tablet~Ribavirin (RBV): Tablet"
82777|NCT02068222|O1|Outcome|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.~ABT-450/ritonavir (r): Tablet~ABT-530: Tablet~Ribavirin (RBV): Tablet"
82778|NCT02068222|O1|Outcome|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.~ABT-450/ritonavir (r): Tablet~ABT-530: Tablet~Ribavirin (RBV): Tablet"
82779|NCT02068222|O1|Outcome|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.~ABT-450/ritonavir (r): Tablet~ABT-530: Tablet~Ribavirin (RBV): Tablet"
82780|NCT02068222|E1|Reported Event|ABT-450/r and ABT-530 Plus RBV|ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
82781|NCT02068157|B1|Baseline|Treatment (Porfimer Sodium, Image-guided I-PDT)|"Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.~Laboratory Biomarker Analysis: Correlative studies~Photodynamic Therapy: Undergo image-guided I-PDT~Porfimer Sodium: Given IV"
82782|NCT02068157|P1|Participant Flow|Treatment (Porfimer Sodium, Image-guided I-PDT)|"Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.~Laboratory Biomarker Analysis: Correlative studies~Photodynamic Therapy: Undergo image-guided I-PDT~Porfimer Sodium: Given IV"
82783|NCT02068157|O1|Outcome|Treatment (Porfimer Sodium, Image-guided I-PDT)|"Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.~Laboratory Biomarker Analysis: Correlative studies~Photodynamic Therapy: Undergo image-guided I-PDT~Porfimer Sodium: Given IV"
82784|NCT02068157|O1|Outcome|Treatment (Porfimer Sodium, Image-guided I-PDT)|"Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.~Laboratory Biomarker Analysis: Correlative studies~Photodynamic Therapy: Undergo image-guided I-PDT~Porfimer Sodium: Given IV"
82785|NCT02068157|E1|Reported Event|Treatment (Porfimer Sodium, Image-guided I-PDT)|"Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.~Laboratory Biomarker Analysis: Correlative studies~Photodynamic Therapy: Undergo image-guided I-PDT~Porfimer Sodium: Given IV"
82786|NCT02068027|B3|Baseline|Total|Total of all reporting groups
82794|NCT02068027|O1|Outcome|Clonidine Gel 0.1%|"Clonidine hydrochloride topical gel, 0.1%~Clonidine Gel 0.1%"
82795|NCT02068027|E2|Reported Event|Placebo|"Placebo gel of identical appearance as active treatment~Placebo"
82796|NCT02068027|E1|Reported Event|Clonidine Gel 0.1%|"Clonidine hydrochloride topical gel, 0.1%~Clonidine Gel 0.1%"
82797|NCT02067728|B3|Baseline|Total|Total of all reporting groups
82798|NCT02067728|B2|Baseline|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
82799|NCT02067728|B1|Baseline|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
82800|NCT02067728|P2|Participant Flow|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
82801|NCT02067728|P1|Participant Flow|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
82802|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
82803|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
82804|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
82805|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
82806|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
82807|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
82808|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
82809|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
82810|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
82811|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
82812|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
82813|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
82814|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
82815|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
82975|NCT02066922|O1|Outcome|DAILIES TOTAL1|Delefilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week.
82816|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
82817|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
82818|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
82819|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
82820|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
82821|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
82822|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
82823|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
82824|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
82825|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
82826|NCT02067728|E2|Reported Event|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
82827|NCT02067728|E1|Reported Event|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
82828|NCT02067676|B7|Baseline|Total|Total of all reporting groups
82829|NCT02067676|B6|Baseline|CJCV1 10 μg / Alum 125 μg (1A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
82830|NCT02067676|B5|Baseline|CJCV1 10 μg / Alum 0 μg (3A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
82831|NCT02067676|B4|Baseline|CJCV1 5 μg / Alum 125 μg (2B)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
82832|NCT02067676|B3|Baseline|CJCV1 5 μg / Alum 0 μg (2A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
82833|NCT02067676|B2|Baseline|CJCV1 2 μg / Alum 125 μg (1B)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
82976|NCT02066922|O2|Outcome|TRUEYE|Narafilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week.
82834|NCT02067676|B1|Baseline|CJCV1 2 μg / Alum 0 μg (1A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
82835|NCT02067676|P6|Participant Flow|CJCV1 10 μg / Alum 125 μg (1A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
82836|NCT02067676|P5|Participant Flow|CJCV1 10 μg / Alum 0 μg (3A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
82837|NCT02067676|P4|Participant Flow|CJCV1 5 μg / Alum 125 μg (2B)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
82838|NCT02067676|P3|Participant Flow|CJCV1 5 μg / Alum 0 μg (2A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
82839|NCT02067676|P2|Participant Flow|CJCV1 2 μg / Alum 125 μg (1B)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
82840|NCT02067676|P1|Participant Flow|CJCV1 2 μg / Alum 0 μg (1A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
82841|NCT02067676|O6|Outcome|CJCV1 10 μg / Alum 125 μg (1A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
82842|NCT02067676|O5|Outcome|CJCV1 10 μg / Alum 0 μg (3A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
82843|NCT02067676|O4|Outcome|CJCV1 5 μg / Alum 125 μg (2B)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
82844|NCT02067676|O3|Outcome|CJCV1 5 μg / Alum 0 μg (2A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
82845|NCT02067676|O2|Outcome|CJCV1 2 μg / Alum 125 μg (1B)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
82846|NCT02067676|O1|Outcome|CJCV1 2 μg / Alum 0 μg (1A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
82861|NCT02067676|O4|Outcome|CJCV1 5 μg / Alum 125 μg (2B)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~CJCV1: The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
82847|NCT02067676|O6|Outcome|CJCV1 10 μg / Alum 125 μg (1A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
82848|NCT02067676|O5|Outcome|CJCV1 10 μg / Alum 0 μg (3A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
82849|NCT02067676|O4|Outcome|CJCV1 5 μg / Alum 125 μg (2B)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
82850|NCT02067676|O3|Outcome|CJCV1 5 μg / Alum 0 μg (2A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
82851|NCT02067676|O2|Outcome|CJCV1 2 μg / Alum 125 μg (1B)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
82852|NCT02067676|O1|Outcome|CJCV1 2 μg / Alum 0 μg (1A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
82853|NCT02067676|O6|Outcome|CJCV1 10 μg / Alum 125 μg (1A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
82854|NCT02067676|O5|Outcome|CJCV1 10 μg / Alum 0 μg (3A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
82855|NCT02067676|O4|Outcome|CJCV1 5 μg / Alum 125 μg (2B)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
82856|NCT02067676|O3|Outcome|CJCV1 5 μg / Alum 0 μg (2A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
82857|NCT02067676|O2|Outcome|CJCV1 2 μg / Alum 125 μg (1B)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
82858|NCT02067676|O1|Outcome|CJCV1 2 μg / Alum 0 μg (1A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
82859|NCT02067676|O6|Outcome|CJCV1 10 μg / Alum 125 μg (1A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
82860|NCT02067676|O5|Outcome|CJCV1 10 μg / Alum 0 μg (3A)|Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum) CJCV1: The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
82862|NCT02067676|O3|Outcome|CJCV1 5 μg / Alum 0 μg (2A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~CJCV1: The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
82863|NCT02067676|O2|Outcome|CJCV1 2 μg / Alum 125 μg (1B)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~CJCV1: The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
82864|NCT02067676|O1|Outcome|CJCV1 2 μg / Alum 0 μg (1A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~CJCV1: The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
82865|NCT02067676|O6|Outcome|CJCV1 10 μg / Alum 125 μg (1A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
82866|NCT02067676|O5|Outcome|CJCV1 10 μg / Alum 0 μg (3A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
82867|NCT02067676|O4|Outcome|CJCV1 5 μg / Alum 125 μg (2B)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
82868|NCT02067676|O3|Outcome|CJCV1 5 μg / Alum 0 μg (2A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
82869|NCT02067676|O2|Outcome|CJCV1 2 μg / Alum 125 μg (1B)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
82870|NCT02067676|O1|Outcome|CJCV1 2 μg / Alum 0 μg (1A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
82871|NCT02067676|E6|Reported Event|CJCV1 10 μg / Alum 125 μg (1A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
82872|NCT02067676|E5|Reported Event|CJCV1 10 μg / Alum 0 μg (3A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
82873|NCT02067676|E4|Reported Event|CJCV1 5 μg / Alum 125 μg (2B)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
82874|NCT02067676|E3|Reported Event|CJCV1 5 μg / Alum 0 μg (2A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
82875|NCT02067676|E2|Reported Event|CJCV1 2 μg / Alum 125 μg (1B)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)~Alhydrogel®, aluminum hydroxide adjuvant (alum)"
82876|NCT02067676|E1|Reported Event|CJCV1 2 μg / Alum 0 μg (1A)|"Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)~Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)"
82877|NCT02067611|B1|Baseline|X0002+Placebo|low dose, BID;middle dose, BID, or high dose, BID.
82878|NCT02067611|P3|Participant Flow|Group C|High dose of X0002/placebo, twice per day.
82879|NCT02067611|P2|Participant Flow|Group B|Middle dose of X0002/placebo, twice per day.
82880|NCT02067611|P1|Participant Flow|Group A|Low dose of X0002/placebo, twice per day
82881|NCT02067611|O3|Outcome|Group C|High dose of X0002/placebo, twice per day.
82882|NCT02067611|O2|Outcome|Group B|Middle dose of X0002/placebo, twice per day.
82883|NCT02067611|O1|Outcome|Group A|Low dose of X0002/placebo, twice per day
82884|NCT02067611|O3|Outcome|Group C|High dose of X0002/placebo, twice per day.
82885|NCT02067611|O2|Outcome|Group B|Middle dose of X0002/placebo, twice per day.
82886|NCT02067611|O1|Outcome|Group A|Low dose of X0002/placebo, twice per day
82887|NCT02067611|O3|Outcome|Group C|High dose of X0002/placebo, twice per day.
82888|NCT02067611|O2|Outcome|Group B|Middle dose of X0002/placebo, twice per day.
82889|NCT02067611|O1|Outcome|Group A|Low dose of X0002/placebo, twice per day
82890|NCT02067611|O3|Outcome|Group C|High dose of X0002/placebo, twice per day.
82891|NCT02067611|O2|Outcome|Group B|Middle dose of X0002/placebo, twice per day.
82892|NCT02067611|O1|Outcome|Group A|Low dose of X0002/placebo, twice per day
82893|NCT02067611|O3|Outcome|Group C|High dose of X0002/placebo, twice per day.
82894|NCT02067611|O2|Outcome|Group B|Middle dose of X0002/placebo, twice per day.
82895|NCT02067611|O1|Outcome|Group A|Low dose of X0002/placebo, twice per day
82896|NCT02067611|O3|Outcome|Group C|High dose of X0002/placebo, twice per day.
82897|NCT02067611|O2|Outcome|Group B|Middle dose of X0002/placebo, twice per day.
82898|NCT02067611|O1|Outcome|Group A|Low dose of X0002/placebo, twice per day
82899|NCT02067611|O3|Outcome|Group C|High dose of X0002/placebo, twice per day.
82900|NCT02067611|O2|Outcome|Group B|Middle dose of X0002/placebo, twice per day.
82901|NCT02067611|O1|Outcome|Group A|Low dose of X0002/placebo, twice per day
82902|NCT02067611|O3|Outcome|Group C|High dose of X0002/placebo, twice per day.
82903|NCT02067611|O2|Outcome|Group B|Middle dose of X0002/placebo, twice per day.
82904|NCT02067611|O1|Outcome|Group A|Low dose of X0002/placebo, twice per day
82905|NCT02067611|O3|Outcome|Group C|High dose of X0002/placebo, twice per day.
82906|NCT02067611|O2|Outcome|Group B|Middle dose of X0002/placebo, twice per day.
82907|NCT02067611|O1|Outcome|Group A|Low dose of X0002/placebo, twice per day
82908|NCT02067611|O3|Outcome|Group C|High dose of X0002/placebo, twice per day
82909|NCT02067611|O2|Outcome|Group B|Middle dose of X0002/placebo, twice per day
82910|NCT02067611|O1|Outcome|Group A|Low dose of X0002/placebo, twice per day
82911|NCT02067611|O2|Outcome|Placebo|Low dose, BID; Middle dose, BID; High dose BID
82912|NCT02067611|O1|Outcome|X0002|low dose, BID;middle dose, BID, or high dose, BID.
82913|NCT02067611|E1|Reported Event|X0002/Placebo|low dose, BID;middle dose, BID, or high dose, BID.
82914|NCT02067585|B4|Baseline|Total|Total of all reporting groups
82915|NCT02067585|B3|Baseline|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82916|NCT02067585|B2|Baseline|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82917|NCT02067585|B1|Baseline|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82918|NCT02067585|P3|Participant Flow|Control|no-operated
82919|NCT02067585|P2|Participant Flow|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82920|NCT02067585|P1|Participant Flow|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82921|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82922|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82973|NCT02066922|P1|Participant Flow|DAILIES TOTAL1/TRUEYE|Delefilcon A and narafilcon A contact lenses (1 in each eye) worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week.
82923|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82924|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82925|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82926|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82927|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82928|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82929|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82930|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82931|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82932|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82933|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82934|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82935|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82936|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82937|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82938|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82939|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82940|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82941|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82974|NCT02066922|O2|Outcome|TRUEYE|Narafilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week.
82942|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82943|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82944|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82945|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82946|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82947|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82948|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82949|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82950|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82951|NCT02067585|E3|Reported Event|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82952|NCT02067585|E2|Reported Event|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82953|NCT02067585|E1|Reported Event|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
82954|NCT02067533|B3|Baseline|Total|Total of all reporting groups
82955|NCT02067533|B2|Baseline|Extension Position|soft tissue repair in extension position
82956|NCT02067533|B1|Baseline|Flexion Position|soft tissue repair in flexion position
82957|NCT02067533|P2|Participant Flow|Extension Position|soft tissue repair in extension position
82958|NCT02067533|P1|Participant Flow|Flexion Position|soft tissue repair in flexion position
82959|NCT02067533|O2|Outcome|Extension Position|soft tissue repair in extension position
82960|NCT02067533|O1|Outcome|Flexion Position|soft tissue repair in flexion position
82961|NCT02067533|E2|Reported Event|Extension Position|soft tissue repair in extension position
82962|NCT02067533|E1|Reported Event|Flexion Position|soft tissue repair in flexion position
82963|NCT02067273|B3|Baseline|Total|Total of all reporting groups
82964|NCT02067273|B2|Baseline|TMS Intervention for 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once a day for 5 days~Transcranial Magnetic Stimulation (TMS)"
82965|NCT02067273|B1|Baseline|TMS Intervention for 1 Day|"Application of Transcranial Magnetic Stimulation (TMS) for 1 day~Transcranial Magnetic Stimulation (TMS)"
82966|NCT02067273|P2|Participant Flow|TMS Intervention for 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once a day for 5 days~Transcranial Magnetic Stimulation (TMS)"
82967|NCT02067273|P1|Participant Flow|TMS Intervention for 1 Day|"Application of Transcranial Magnetic Stimulation (TMS) for 1 day~Transcranial Magnetic Stimulation (TMS)"
82968|NCT02067273|O2|Outcome|TMS Intervention (5 Days)|"Application of Transcranial Magnetic Stimulation (TMS) once a day for 5 days~Transcranial Magnetic Stimulation (TMS)"
82969|NCT02067273|O1|Outcome|TMS Intervention (1 Day)|"Application of Transcranial Magnetic Stimulation (TMS) for 1 day~Transcranial Magnetic Stimulation (TMS)"
82970|NCT02067273|E2|Reported Event|TMS Intervention for 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once a day for 5 days~Transcranial Magnetic Stimulation (TMS)"
82971|NCT02067273|E1|Reported Event|TMS Intervention for 1 Day|"Application of Transcranial Magnetic Stimulation (TMS) for 1 day~Transcranial Magnetic Stimulation (TMS)"
82972|NCT02066922|B1|Baseline|DAILIES TOTAL1/TRUEYE|Delefilcon A and narafilcon A contact lenses (1 in each eye) worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week.
84010|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
82977|NCT02066922|O1|Outcome|DAILIES TOTAL1|Delefilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week
82978|NCT02066922|E2|Reported Event|TRUEYE|Narafilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week
82979|NCT02066922|E1|Reported Event|DAILIES TOTAL1|Delefilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week
82980|NCT02066896|B3|Baseline|Total|Total of all reporting groups
82981|NCT02066896|B2|Baseline|Active Comparator: Lasertherapy|"Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks.~Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)"
82982|NCT02066896|B1|Baseline|Sham Comparator: Sham Lasertherapy|"Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.~Sham Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group)."
82983|NCT02066896|P2|Participant Flow|Active Comparator: Lasertherapy|"Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks.~Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)"
82984|NCT02066896|P1|Participant Flow|Sham Comparator: Sham Lasertherapy|"Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.~Sham Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group)."
82985|NCT02066896|O2|Outcome|Active Comparator: Lasertherapy|"Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks.~Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)"
82986|NCT02066896|O1|Outcome|Sham Comparator: Sham Lasertherapy|"Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.~Sham Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group)."
82987|NCT02066896|O2|Outcome|Active Comparator: Lasertherapy|"Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks.~Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)"
82988|NCT02066896|O1|Outcome|Sham Comparator: Sham Lasertherapy|"Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.~Sham Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group)."
82989|NCT02066896|O2|Outcome|Active Comparator: Lasertherapy|"Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks.~Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)"
82990|NCT02066896|O1|Outcome|Sham Comparator: Sham Lasertherapy|"Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.~Sham Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group)."
82991|NCT02066896|E2|Reported Event|Active Comparator: Lasertherapy|"Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks.~Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)"
82992|NCT02066896|E1|Reported Event|Sham Comparator: Sham Lasertherapy|"Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.~Sham Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group)."
82993|NCT02066857|B3|Baseline|Total|Total of all reporting groups
82994|NCT02066857|B2|Baseline|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
82995|NCT02066857|B1|Baseline|Generic Plaster or Fiberglass Cast Group|Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
82996|NCT02066857|P2|Participant Flow|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
82997|NCT02066857|P1|Participant Flow|Generic Plaster or Fiberglass Cast Group|Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
82998|NCT02066857|O2|Outcome|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
82999|NCT02066857|O1|Outcome|Generic Plaster or Fiberglass Cast Group|Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
83000|NCT02066857|O1|Outcome|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
83001|NCT02066857|O1|Outcome|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
83002|NCT02066857|O1|Outcome|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
83670|NCT02063217|E1|Reported Event|Sleep Induction|"6.5-7.5 grams of sodium oxybate~Sodium Oxybate: Sodium oxybate h.s."
83003|NCT02066857|O2|Outcome|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
83004|NCT02066857|O1|Outcome|Generic Plaster or Fiberglass Cast Group|Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
83005|NCT02066857|O1|Outcome|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
83006|NCT02066857|O2|Outcome|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
83007|NCT02066857|O1|Outcome|Generic Plaster or Fiberglass Cast Group|Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
83008|NCT02066857|E2|Reported Event|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
83009|NCT02066857|E1|Reported Event|Generic Plaster or Fiberglass Cast Group|Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
83010|NCT02066740|B1|Baseline|EverFlex™ Stent With Entrust™ Delivery System|EverFlex™ stent with Entrust™ delivery system
83011|NCT02066740|P1|Participant Flow|EverFlex™ Stent With Entrust™ Delivery System|Subjects were treated with the EverFlex™ stent with Entrust™ delivery system
83012|NCT02066740|O1|Outcome|EverFlex™ Stent With Entrust™ Delivery System|EverFlex™ stent with Entrust™ delivery system
83013|NCT02066740|O1|Outcome|EverFlex™ Stent With Entrust™ Delivery System|EverFlex™ stent with Entrust™ delivery system
83014|NCT02066740|E1|Reported Event|EverFlex™ Stent With Entrust™ Delivery System|EverFlex™ stent with Entrust™ delivery system
83015|NCT02066727|B3|Baseline|Total|Total of all reporting groups
83016|NCT02066727|B2|Baseline|Dexmedetomidine|Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.
83017|NCT02066727|B1|Baseline|Normal Saline|Normal Saline is administrated as an adjuvant of lidocaine.
83018|NCT02066727|P2|Participant Flow|Dexmedetomidine|Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.
83019|NCT02066727|P1|Participant Flow|Normal Saline|Normal Saline is administrated as an adjuvant of lidocaine.
83020|NCT02066727|O2|Outcome|Dexmedetomidine|"Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.~Dexmedetomidine: Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg."
83021|NCT02066727|O1|Outcome|Normal Saline|"Normal Saline is administrated as an adjuvant of lidocaine.~Normal Saline: Normal Saline is administrated as an adjuvant of lidocaine."
83022|NCT02066727|E2|Reported Event|Dexmedetomidine|Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.
83023|NCT02066727|E1|Reported Event|Normal Saline|Normal Saline is administrated as an adjuvant of lidocaine.
83024|NCT02066402|B3|Baseline|Total|Total of all reporting groups
83025|NCT02066402|B2|Baseline|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
83026|NCT02066402|B1|Baseline|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
83027|NCT02066402|P2|Participant Flow|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
83028|NCT02066402|P1|Participant Flow|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
83029|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
83030|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
83031|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
83032|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
83033|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
83034|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
83035|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
83036|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
83037|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
83038|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
83039|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
83040|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
83041|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
83042|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
83043|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
83101|NCT02064985|B2|Baseline|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83044|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
83045|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
83046|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
83047|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
83048|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
83049|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
83050|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
83051|NCT02066402|E2|Reported Event|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
83052|NCT02066402|E1|Reported Event|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
83053|NCT02066233|B3|Baseline|Total|Total of all reporting groups
83054|NCT02066233|B2|Baseline|Subjects With Reflux and/or Heartburn|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
83055|NCT02066233|B1|Baseline|Subjects With Barrett's Esophagus|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
83056|NCT02066233|P2|Participant Flow|Subjects With Reflux and/or Heartburn|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
83057|NCT02066233|P1|Participant Flow|Subjects With Barrett's Esophagus|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
83058|NCT02066233|O2|Outcome|Subjects With Reflux and/or Heartburn|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
83059|NCT02066233|O1|Outcome|Subjects With Barrett's Esophagus|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
83060|NCT02066233|O2|Outcome|Subjects With Reflux and/or Heartburn|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
83061|NCT02066233|O1|Outcome|Subjects With Barrett's Esophagus|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
83062|NCT02066233|E2|Reported Event|Subjects With Reflux and/or Heartburn|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
83063|NCT02066233|E1|Reported Event|Subjects With Barrett's Esophagus|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
83064|NCT02066051|B1|Baseline|IPL Treatment|"Subjects who had inactive chronic graft versus host disease (GVHD) after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea unresponsive to conventional management were recruited. Subjects were treated with 4 monthly sessions of intense pulsed light (IPL) and meibomian gland expression.~IPL: Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.~Meibomian Gland Expression: After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands."
83065|NCT02066051|P1|Participant Flow|IPL Treatment|"Subjects who had inactive chronic graft versus host disease (GVHD) after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea unresponsive to conventional management were recruited. Subjects were treated with 4 monthly sessions of intense pulsed light (IPL) and meibomian gland expression.~IPL: Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.~Meibomian Gland Expression: After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands."
83066|NCT02066051|O1|Outcome|IPL Treatment|"Subjects who had inactive chronic graft versus host disease (GVHD) after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea unresponsive to conventional management were recruited. Subjects were treated with 4 monthly sessions of intense pulsed light (IPL) and meibomian gland expression.~IPL: Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.~Meibomian Gland Expression: After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands."
83067|NCT02066051|O1|Outcome|IPL Treatment|"Subjects who had inactive chronic graft versus host disease (GVHD) after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea unresponsive to conventional management were recruited. Subjects were treated with 4 monthly sessions of intense pulsed light (IPL) and meibomian gland expression.~IPL: Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.~Meibomian Gland Expression: After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands."
83102|NCT02064985|B1|Baseline|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83103|NCT02064985|P3|Participant Flow|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83068|NCT02066051|E1|Reported Event|IPL Treatment|"Subjects who had inactive chronic graft versus host disease (GVHD) after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea unresponsive to conventional management were recruited. Subjects were treated with 4 monthly sessions of intense pulsed light (IPL) and meibomian gland expression.~IPL: Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.~Meibomian Gland Expression: After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands."
83069|NCT02065895|B1|Baseline|Closed-loop Control|Closed-loop control was performed from 9:00 PM to 2:00 the day following admission on three occasions: once with a glucose-value-used-for control calculated to be higher than the true blood glucose (analogous to a sensor glucose signal that is miss-calibrated); once with the value equal to blood glucose (analogous to a sensor signal with no calibration), and once with the value calculated to be lower than blood glucose. Six different arms were utilized, defined by the differing sequences of each of the three values used for control (no error, high error and low error previously defined). On each occasion control was separated into the nighttime period (midnight to 08:00 AM) and breakfast period (8:00 AM to 2:00 PM).
83070|NCT02065895|P6|Participant Flow|LOW Error First, HIGH Error Second, NO Error Third|In this arm, subjects were were randomized to undergo in-clinic closed-loop control of nighttime and breakfast glucose on three occasions: first with the glucose value used for control calculated to be 20% lower than the true glucose value (LOW error), then second with the value calculated to be 33% higher than the true value (HIGH error), and then third with the value calculated to be equal the true value (NO error). These conditions reflect real-life conditions that would be expected if closed-loop artificial pancreas control is effected with different sensor calibration error. No meal announcement was provided (simulates condition where patient forgets to announce meal), and all subjects were controlled with the same closed-loop gain (simulates conditions where an individual's insulin sensitivity changes). Intervention period: 17 hours; minimum washout period was 7 hours, maximum was 62 days (varied among subjects, allowed up to 3 months to complete all 3 interventions).
83071|NCT02065895|P5|Participant Flow|LOW Error First, NO Error Second, HIGH Error Third|In this arm, subjects were were randomized to undergo in-clinic closed-loop control of nighttime and breakfast glucose on three occasions: first with the glucose value used for control calculated to be 20% lower than the true glucose value (LOW error), then second with the value calculated to equal the true value (NO error), and then third with the value calculated to be 33% higher than the true value. These conditions reflect real-life conditions that would be expected if closed-loop artificial pancreas control is effected with different sensor calibration error. No meal announcement was provided (simulates condition where patient forgets to announce meal), and all subjects were controlled with the same closed-loop gain (simulates conditions where an individual's insulin sensitivity changes). Intervention period: 17 hours; minimum washout period was 7 hours,maximum was 62 days (varied among subjects, allowed up to 3 months to complete all 3 interventions).
83072|NCT02065895|P4|Participant Flow|NO Error First, HIGH Error Second, LOW Error Third|In this arm, subjects were were randomized to undergo in-clinic closed-loop control of nighttime and breakfast glucose on three occasions: first with the glucose value used for control calculated equal the true value (NO error), and then second with the value calculated as 33% higher than the true glucose value (HIGH error), and then third with the value calculated to to be 20% lower than the true glucose value (LOW error). These conditions reflect real-life conditions that would be expected if closed-loop artificial pancreas control is effected with different sensor calibration error. No meal announcement was provided (simulates condition where patient forgets to announce meal), and all subjects were controlled with the same closed-loop gain (simulates conditions where an individual's insulin sensitivity changes).Intervention period: 17 hours; minimum washout period was 7 hours, maximum was 62 days (varied among subjects, allowed up to 3 months to complete all 3 interventions).
83073|NCT02065895|P3|Participant Flow|NO Error First, LOW Error Second, HIGH Error Third|In this arm, subjects were were randomized to undergo in-clinic closed-loop control of nighttime and breakfast glucose on three occasions: first with the glucose value used for control equal the true value (NO error), then second with the value calculated to be 20% lower than the true value (LOW error), and then third with the value calculated to be 33% higher than the true glucose value (HIGH error). These conditions reflect real-life conditions that would be expected if closed-loop artificial pancreas control is effected with different sensor calibration error. No meal announcement was provided (simulates condition where patient forgets to announce meal), and all subjects were controlled with the same closed-loop gain (simulates conditions where an individual's insulin sensitivity changes). Intervention period: 17 hours; minimum washout period was 7 hours, maximum was 62 days (varied among subjects, allowed up to 3 months to complete all 3 interventions).
83074|NCT02065895|P2|Participant Flow|HIGH Error First, NO Error Second, Then LOW Error Third|In this arm, subjects were were randomized to undergo in-clinic closed-loop control of nighttime and breakfast glucose on three occasions: first with the glucose value used for control calculated to be 33% higher than the true glucose value (HIGH error), then second with the value calculated to equal the true value (NO error), and then third with the value calculated to be 20% lower than the true value (LOW error). These conditions reflect real-life conditions that would be expected if closed-loop artificial pancreas control is effected with different sensor calibration error. No meal announcement was provided (simulates condition where patient forgets to announce meal), and all subjects were controlled with the same closed-loop gain (simulates conditions where an individual's insulin sensitivity changes). Intervention period: 17 hours; minimum washout period was 7 hours, maximum was 62 days (varied among subjects, allowed up to 3 months to complete all 3 interventions).
83098|NCT02065453|E1|Reported Event|Disposable or Reusable Energy Sources|Each patient serve as their own control. One side of the uterine attachments would be transected using the disposable device, the Ligasure, and the other using the two reusable devices, the Robi bipolar and Storz laparoscopic shears. It is our standard practice that the attending surgeon is on the patient's left side while the resident physician is on the patients right. To eliminate the bias of surgical experience, we will randomize the energy source used on each side for every case. Therefore, the number of cases performed by the attending surgeon with the disposable or reusable energy sources, will equal that of the less experienced resident surgeon.
83075|NCT02065895|P1|Participant Flow|HIGH Error First, LOW Error Second, Then NO Error Third|In this arm, subjects were randomized to undergo in-clinic closed-loop control of nighttime and breakfast glucose on three occasions: first with the glucose value used for control calculated to be 33% higher than the true glucose value (HIGH error), then second with the value calculated to be 20% lower than the true value (LOW error), then third with the value equal to the true value (NO error). These conditions reflect real-life conditions that would be expected if closed-loop artificial pancreas control is effected with different sensor calibration error. No meal announcement was provided (simulates condition where patient forgets to announce meal), and all subjects were controlled with the same closed-loop gain (simulates conditions where an individual's insulin sensitivity changes). Intervention period: 17 hours; minimum washout period was 7 hours, maximum was 62 days (varied among subjects, allowed up to 3 months to complete all 3 interventions).
83076|NCT02065895|O3|Outcome|LOW Error|Closed-loop control performed with sensor glucose reading lower than blood glucose behaves as if the controller gain has been lowered and the target increased
83077|NCT02065895|O2|Outcome|NO Errror|Reference nighttime response for comparison with closed-loop control with sensor glucose reading higher than blood glucose and lower than blood glucose.
83078|NCT02065895|O1|Outcome|HIGH Error|Closed-loop control performed with sensor glucose reading higher than blood glucose behaves as if the controller gain has been increased and the target lowered
83079|NCT02065895|O3|Outcome|Gain Decreased and Target Increased|Closed-loop control performed with a sensor reading lower than blood glucose behave as if the control gain has been lowered and the target increased
83080|NCT02065895|O2|Outcome|Nadir Mean|Closed-loop control performed with a sensor reading higher than blood glucose behave as if the control gain has been increased and the target set lowered
83081|NCT02065895|O1|Outcome|Gain Increased and Target Decreased|Closed-loop control performed with a sensor reading higher than blood glucose behave as if the control gain has been increased and the target set lowered
83082|NCT02065895|O3|Outcome|LOW Error|Glucose sensor errors leading to sensor glucose reading higher than that true blood glucose result in closed-loop control systems (artificial pancreas) behaving as if the control gain is increased and the target is lowered. In this arm we study closed-loop control with a sensor signal reading 20% lower than blood glucose.
83083|NCT02065895|O2|Outcome|NO Error|Glucose sensor errors leading to sensor glucose reading higher than that true blood glucose result in closed-loop control systems (artificial pancreas) behaving as if the control gain is increased and the target is lowered. In this arm we study closed-loop control with a sensor signal reading equal to blood glucose.
83084|NCT02065895|O1|Outcome|HIGH Error|Glucose sensor errors leading to sensor glucose reading higher than that true blood glucose result in closed-loop control systems (artificial pancreas) behaving as if the control gain is increased and the target is lowered. In this arm we study closed-loop control with a sensor signal reading 33% higher than blood glucose.
83085|NCT02065895|E6|Reported Event|LOW Error First, HIGH Error Second, NO Error Third|Nighttime and Breakfast closed-loop glucose control was performed on 3 occasions: first with the glucose value used for control calculated to be 20% lower than the true glucose (LOW error), then with the value calculated to be 30% higher than the true value (HIGH error) and then with the value equal to the true glucose (NO error)
83086|NCT02065895|E5|Reported Event|LOW Error First, NO Error Second, HIGH Error Third|Nighttime and Breakfast closed-loop glucose control was performed on 3 occasions: first with the glucose value used for control equal 80% of the true value (LOW error), then with value equal to the true glucose (NO error), and then with the value calculated to be calculated to be 33% higher than the true glucose (HIGH error).
83087|NCT02065895|E4|Reported Event|NO Error First, LOW Error Second, HIGH Error Third|Nighttime and Breakfast closed-loop glucose control was performed on 3 occasions: first with the glucose value used for control equal to the true glucose (NO error), then with the value calculated to be 80% of the true value (LOW error) and then with the value calculated to be 33% higher than the true glucose (HIGH error)
83088|NCT02065895|E3|Reported Event|NO Error First, HIGH Error Second, LOW Error Third|Nighttime and Breakfast closed-loop glucose control was performed on 3 occasions: first with the glucose value used for control equal to the true glucose (NO error), then with the value calculated to be 33% higher than the true glucose (HIGH error), and then with the value calculated to be 80% of the true value (LOW error).
83089|NCT02065895|E2|Reported Event|HIGH Error First, LOW Error Second, NO Error Third|Nighttime and Breakfast closed-loop glucose control was performed on 3 occasions: first with the glucose value used for control calculated to be 33% higher than the true glucose (HIGH error), then with the value calculated to be 80% of the true value (LOW error), and then with the value equal to the true glucose (NO error).
83090|NCT02065895|E1|Reported Event|HIGH Error First, NO Error Second, LOW Error Third|Nighttime and Breakfast closed-loop glucose control was performed on 3 occasions: first with the glucose value used for control calculated to be 33% higher than the true glucose (HIGH error), then with the value equal to the true glucose (NO error), and then with the value calculated to be 80% of the true value (LOW error).
83091|NCT02065453|B3|Baseline|Total|Total of all reporting groups
83092|NCT02065453|B2|Baseline|Disposable Device Right and Reusable Devices Left|25 women were randomized to receive disposable device right and reusable devices left
83093|NCT02065453|B1|Baseline|Disposable Device Left and Resusable Devices Right|27 women were randomized to receive disposable device left and resusable devices right
83094|NCT02065453|P2|Participant Flow|Disposable Device - Right & Reusable Devices - Left|25 women were randomized to attending physicians using the disposable device on the right and reusable devices on the left
83095|NCT02065453|P1|Participant Flow|Disposable Device - Left & Reusable Devices - Right|27 women were randomized to attending physicians using the disposable device on the left and reusable devices on the right.
83096|NCT02065453|O2|Outcome|Reusable|Uterine Vessel Desiccation and Electrosurgical Cutting Time (min) Resident and Attending Physicians Combined
83097|NCT02065453|O1|Outcome|Disposable|Uterine Vessel Desiccation and Electrosurgical Cutting Time (min) Resident and Attending Physicians Combined
83099|NCT02064985|B4|Baseline|Total|Total of all reporting groups
83100|NCT02064985|B3|Baseline|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83671|NCT02063035|B3|Baseline|Total|Total of all reporting groups
83104|NCT02064985|P2|Participant Flow|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83105|NCT02064985|P1|Participant Flow|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83106|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83107|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83108|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83109|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83110|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83111|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83112|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83113|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83114|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83115|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83116|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83117|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83118|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83119|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83120|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83121|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83122|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83123|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83124|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83125|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83126|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83127|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83128|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83129|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83130|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83131|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83132|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83133|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83134|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83135|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83136|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83137|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83138|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83139|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83140|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83141|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83142|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83143|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83144|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
84011|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
83145|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83146|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83147|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83148|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83149|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83150|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83151|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83152|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83153|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83154|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83155|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83156|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83157|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83158|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83159|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83160|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83161|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83162|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83163|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83164|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83165|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83166|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83167|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83168|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83169|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83170|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83171|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83172|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83173|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83174|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83175|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83176|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83177|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83178|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83179|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83180|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83181|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83182|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83183|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83184|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83185|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
84012|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
83186|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83187|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83188|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83189|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83190|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83191|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83192|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83193|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83194|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83195|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83196|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83197|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83198|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83199|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83200|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83201|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83202|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83203|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83204|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83205|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83206|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83207|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83208|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83209|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83210|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83211|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83212|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83213|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83214|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83215|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83216|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83217|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83218|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83219|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83220|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83221|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83222|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83223|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83224|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83225|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83226|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
84013|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
83227|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83228|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83229|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83230|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83231|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83232|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83233|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83234|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83235|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83236|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83237|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83238|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83239|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83240|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83241|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83242|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83243|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83244|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83245|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83246|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83247|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83248|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83249|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83250|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83251|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83252|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83253|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83254|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83255|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83256|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83257|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83258|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83259|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83260|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83261|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83262|NCT02064985|E3|Reported Event|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
83263|NCT02064985|E2|Reported Event|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
83264|NCT02064985|E1|Reported Event|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
83265|NCT02064920|B3|Baseline|Total|Total of all reporting groups
83266|NCT02064920|B2|Baseline|Donepezil|During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
83267|NCT02064920|B1|Baseline|Placebo|Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
84014|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
83268|NCT02064920|P2|Participant Flow|Donepezil|During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
83269|NCT02064920|P1|Participant Flow|Placebo|Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
83270|NCT02064920|O2|Outcome|Donepezil|During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
83271|NCT02064920|O1|Outcome|Placebo|Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
83272|NCT02064920|O2|Outcome|Donepezil|During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
83273|NCT02064920|O1|Outcome|Placebo|Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
83274|NCT02064920|E2|Reported Event|Donepezil|During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
83275|NCT02064920|E1|Reported Event|Placebo|Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
83276|NCT02064907|B3|Baseline|Total|Total of all reporting groups
83277|NCT02064907|B2|Baseline|Dexlansoprazole Capsules + Dexlansoprazole OD Tablets|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 2.
83278|NCT02064907|B1|Baseline|Dexlansoprazole OD Tablets + Dexlansoprazole Capsules|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by one dexlansoprazole 60 mg, capsule, orally, once daily for 5 days in Period 2.
83279|NCT02064907|P2|Participant Flow|Dexlansoprazole Capsules + Dexlansoprazole OD Tablets|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 2.
83280|NCT02064907|P1|Participant Flow|Dexlansoprazole OD Tablets + Dexlansoprazole Capsules|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by one dexlansoprazole 60 mg, capsule, orally, once daily for 5 days in Period 2.
83281|NCT02064907|O2|Outcome|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
83282|NCT02064907|O1|Outcome|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
83283|NCT02064907|O2|Outcome|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
83284|NCT02064907|O1|Outcome|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
83285|NCT02064907|O2|Outcome|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
83286|NCT02064907|O1|Outcome|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
83287|NCT02064907|O2|Outcome|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
83288|NCT02064907|O1|Outcome|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
83289|NCT02064907|O2|Outcome|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
83290|NCT02064907|O1|Outcome|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
83291|NCT02064907|O2|Outcome|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
83292|NCT02064907|O1|Outcome|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
83293|NCT02064907|E2|Reported Event|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
83294|NCT02064907|E1|Reported Event|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
83295|NCT02064894|B4|Baseline|Total|Total of all reporting groups
83296|NCT02064894|B3|Baseline|Ibuprofen and Placebo of Morphine|"Ibuprofen 10mg/kg (max. 600 mg) and placebo of morphine both administered once during the 2-hour time frame of the study~Oral ibuprofen: oral ibuprofen combine to a placebo is the active comparator"
83297|NCT02064894|B2|Baseline|Morphine and Placebo of Ibuprofen|"Oral morphine 0.2mg/kg (max. 15 mg) and a placebo of ibuprofen both administered once during the 2-hour time frame of the study~Oral morphine: Oral morphine 0.2 mg/kg (syrup) up to a maximum dosage of 15 mg, administered once during the study"
83298|NCT02064894|B1|Baseline|Oral Morphine and Oral Ibuprofen|"Oral morphine (syrup) 0.2mg/kg (max. 15 mg) and oral ibuprofen (syrup) 10mg/kg (max. 600 mg) both administered once during the 2 hour-study time frame~oral morphine and oral ibuprofen: The combination of oral morphine and oral ibuprofen is one of the Experimental arm group"
83299|NCT02064894|P3|Participant Flow|Ibuprofen and Placebo of Morphine|"Ibuprofen 10mg/kg (max. 600 mg) and placebo of morphine both administered once during the 2-hour time frame of the study~Oral ibuprofen: oral ibuprofen combine to a placebo is the active comparator"
83300|NCT02064894|P2|Participant Flow|Morphine and Placebo of Ibuprofen|"Oral morphine 0.2mg/kg (max. 15 mg) and a placebo of ibuprofen both administered once during the 2-hour time frame of the study~Oral morphine: Oral morphine 0.2 mg/kg (syrup) up to a maximum dosage of 15 mg, administered once during the study"
83301|NCT02064894|P1|Participant Flow|Oral Morphine and Oral Ibuprofen|"Oral morphine (syrup) 0.2mg/kg (max. 15 mg) and oral ibuprofen (syrup) 10mg/kg (max. 600 mg) both administered once during the 2 hour-study time frame~oral morphine and oral ibuprofen: The combination of oral morphine and oral ibuprofen is one of the Experimental arm group"
84015|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
83302|NCT02064894|O3|Outcome|Ibuprofen and Placebo of Morphine|"Ibuprofen 10mg/kg (max. 600 mg) and placebo of morphine both administered once during the 2-hour time frame of the study~Oral ibuprofen: oral ibuprofen combine to a placebo is the active comparator"
83303|NCT02064894|O2|Outcome|Morphine and Placebo of Ibuprofen|"Oral morphine 0.2mg/kg (max. 15 mg) and a placebo of ibuprofen both administered once during the 2-hour time frame of the study~Oral morphine: Oral morphine 0.2 mg/kg (syrup) up to a maximum dosage of 15 mg, administered once during the study"
83304|NCT02064894|O1|Outcome|Oral Morphine and Oral Ibuprofen|"Oral morphine (syrup) 0.2mg/kg (max. 15 mg) and oral ibuprofen (syrup) 10mg/kg (max. 600 mg) both administered once during the 2 hour-study time frame~oral morphine and oral ibuprofen: The combination of oral morphine and oral ibuprofen is one of the Experimental arm group"
83305|NCT02064894|O3|Outcome|Ibuprofen and Placebo of Morphine|"Ibuprofen 10mg/kg (max. 600 mg) and placebo of morphine both administered once during the 2-hour time frame of the study~Oral ibuprofen: oral ibuprofen combine to a placebo is the active comparator"
83306|NCT02064894|O2|Outcome|Morphine and Placebo of Ibuprofen|"Oral morphine 0.2mg/kg (max. 15 mg) and a placebo of ibuprofen both administered once during the 2-hour time frame of the study~Oral morphine: Oral morphine 0.2 mg/kg (syrup) up to a maximum dosage of 15 mg, administered once during the study"
83307|NCT02064894|O1|Outcome|Oral Morphine and Oral Ibuprofen|"Oral morphine (syrup) 0.2mg/kg (max. 15 mg) and oral ibuprofen (syrup) 10mg/kg (max. 600 mg) both administered once during the 2 hour-study time frame~oral morphine and oral ibuprofen: The combination of oral morphine and oral ibuprofen is one of the Experimental arm group"
83308|NCT02064894|E3|Reported Event|Ibuprofen and Placebo of Morphine|"Ibuprofen 10mg/kg (max. 600 mg) and placebo of morphine both administered once during the 2-hour time frame of the study~Oral ibuprofen: oral ibuprofen combine to a placebo is the active comparator"
83309|NCT02064894|E2|Reported Event|Morphine and Placebo of Ibuprofen|"Oral morphine 0.2mg/kg (max. 15 mg) and a placebo of ibuprofen both administered once during the 2-hour time frame of the study~Oral morphine: Oral morphine 0.2 mg/kg (syrup) up to a maximum dosage of 15 mg, administered once during the study"
83310|NCT02064894|E1|Reported Event|Oral Morphine and Oral Ibuprofen|"Oral morphine (syrup) 0.2mg/kg (max. 15 mg) and oral ibuprofen (syrup) 10mg/kg (max. 600 mg) both administered once during the 2 hour-study time frame~oral morphine and oral ibuprofen: The combination of oral morphine and oral ibuprofen is one of the Experimental arm group"
83311|NCT02064439|B4|Baseline|Total|Total of all reporting groups
83312|NCT02064439|B3|Baseline|Acetylsalicylic (ASA) 100 mg, OD|Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
83313|NCT02064439|B2|Baseline|Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD|Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
83314|NCT02064439|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD|Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
83315|NCT02064439|P3|Participant Flow|Acetylsalicylic (ASA) 100 mg, OD|Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
83316|NCT02064439|P2|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD|Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
83317|NCT02064439|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD|Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
83318|NCT02064439|O3|Outcome|Acetylsalicylic (ASA) 100 mg, OD|Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
83319|NCT02064439|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD|Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
83320|NCT02064439|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD|Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
83321|NCT02064439|O3|Outcome|Acetylsalicylic (ASA) 100 mg, OD|Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
83322|NCT02064439|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD|Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
83386|NCT02063880|P1|Participant Flow|Urgent ART|"Initiation of highly active antiretroviral therapy (HAART) within 48 hours of enrollment.~Antiretroviral therapy will include regimens recommended by the Kenyan Ministry of Health.~Urgent ART: Children will be started on HAART <48 hours after enrollment."
83323|NCT02064439|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD|Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
83324|NCT02064439|O3|Outcome|Acetylsalicylic (ASA) 100 mg, OD|Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
83325|NCT02064439|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD|Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
83326|NCT02064439|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD|Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
83327|NCT02064439|O3|Outcome|Acetylsalicylic (ASA) 100 mg, OD|Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
83328|NCT02064439|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD|Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
83329|NCT02064439|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD|Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
83330|NCT02064439|E3|Reported Event|Acetylsalicylic (ASA) 100 mg, OD|Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
83331|NCT02064439|E2|Reported Event|Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD|Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
83332|NCT02064439|E1|Reported Event|Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD|Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
83333|NCT02064270|B3|Baseline|Total|Total of all reporting groups
83334|NCT02064270|B2|Baseline|Standard Dressings|"Standard postsurgical dressings~Standard postsurgical dressings: Use of Standard postsurgical dressings"
83335|NCT02064270|B1|Baseline|Negative Pressure Wound Therapy|"Single-Use Negative Pressure Wound Therapy (NPWT)~Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy"
83336|NCT02064270|P2|Participant Flow|Standard Dressings|"Standard postsurgical dressings~Standard postsurgical dressings: Use of Standard postsurgical dressings"
83337|NCT02064270|P1|Participant Flow|Negative Pressure Wound Therapy|"Single-Use Negative Pressure Wound Therapy (NPWT)~Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy"
83338|NCT02064270|O2|Outcome|Standard Dressings|"Standard postsurgical dressings~Standard postsurgical dressings: Use of Standard postsurgical dressings"
83339|NCT02064270|O1|Outcome|Negative Pressure Wound Therapy|"Single-Use Negative Pressure Wound Therapy (NPWT)~Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy"
83340|NCT02064270|O2|Outcome|Standard Dressings|"Standard postsurgical dressings~Standard postsurgical dressings: Use of Standard postsurgical dressings"
83341|NCT02064270|O1|Outcome|Negative Pressure Wound Therapy|"Single-Use Negative Pressure Wound Therapy (NPWT)~Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy"
83342|NCT02064270|O2|Outcome|Standard Dressings|"Standard postsurgical dressings~Standard postsurgical dressings: Use of Standard postsurgical dressings"
83343|NCT02064270|O1|Outcome|Negative Pressure Wound Therapy|"Single-Use Negative Pressure Wound Therapy (NPWT)~Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy"
83344|NCT02064270|O1|Outcome|Negative Pressure Wound Therapy|"Single-Use Negative Pressure Wound Therapy (NPWT)~Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy"
83345|NCT02064270|O2|Outcome|Standard Dressings|"Standard postsurgical dressings~Standard postsurgical dressings: Use of Standard postsurgical dressings"
83346|NCT02064270|O1|Outcome|Negative Pressure Wound Therapy|"Single-Use Negative Pressure Wound Therapy (NPWT)~Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy"
83347|NCT02064270|O2|Outcome|Standard Dressings|"Standard postsurgical dressings~Standard postsurgical dressings: Use of Standard postsurgical dressings"
83348|NCT02064270|O1|Outcome|Negative Pressure Wound Therapy|"Single-Use Negative Pressure Wound Therapy (NPWT)~Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy"
83349|NCT02064270|E2|Reported Event|Standard Dressings|"Standard postsurgical dressings~Standard postsurgical dressings: Use of Standard postsurgical dressings"
83350|NCT02064270|E1|Reported Event|Negative Pressure Wound Therapy|"Single-Use Negative Pressure Wound Therapy (NPWT)~Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy"
83351|NCT02064231|B1|Baseline|Overall Study Population|
83352|NCT02064231|P4|Participant Flow|Oloplast Test A, Coloplast Test D, Own Product|"The subjects first test Coloplast Test A and thereafter Coloplast Test D and finally their own product for 14 days~Coloplast Test A: Coloplast Test A is a new ostomy appliance developed by Coloplast A/S~Coloplast Test D: Coloplast Test D is a newly developed ostomy appliance developed by Coloplast A/S~Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others."
83353|NCT02064231|P3|Participant Flow|Coloplast Test D, Coloplast Test C, Own Product|"The subjects first test Coloplast Test D and thereafter Coloplast Test C and finally their own product for 14 days~Coloplast Test D: Coloplast Test A is a new ostomy appliance developed by Coloplast A/S~Coloplast Test C: Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S~Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others."
83354|NCT02064231|P2|Participant Flow|Coloplast Test C , Coloplast Test D, Own Product|"The subjects first test Coloplast Test C and thereafter Coloplast Test D and finally their own product for 14 days~Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.~Coloplast Test C: Coloplast Test C is a new ostomy appliance developed by Coloplast A/S~Coloplast Test D: Coloplast Test D is a new ostomy appliance developed by Coloplast A/S"
83355|NCT02064231|P1|Participant Flow|Coloplast Test A, Coloplast Test B, Own Product|"The subjects first test Coloplast Test A and thereafter Coloplast Test B and finally their own product for 14 days~Coloplast Test A: Coloplast Test A is a new ostomy appliance developed by Coloplast A/S~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S~Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others."
83356|NCT02064231|O5|Outcome|Own Product|Subjects collecting data on own product
83357|NCT02064231|O4|Outcome|Coloplast Test D|Subjects testing Test D
83358|NCT02064231|O3|Outcome|Coloplast Test C|Subjects testing Test C
83359|NCT02064231|O2|Outcome|Coloplast Test B|Subjects testing Test B
83360|NCT02064231|O1|Outcome|Coloplast Test A|Subjects testing Test A
83361|NCT02064231|E5|Reported Event|Own Product|Subjects collecting data on own product
83362|NCT02064231|E4|Reported Event|Coloplast Test D|Subjects testing Test D
83363|NCT02064231|E3|Reported Event|Coloplast Test C|Subjects testing Test C
83364|NCT02064231|E2|Reported Event|Coloplast Test B|Subjects testing Test B
83365|NCT02064231|E1|Reported Event|Coloplast Test A|Subjects testing Test A
83366|NCT02064205|B1|Baseline|Overall Baseline Charactistics of 32 Slightly Overweight Women|Baseline data of the subjects were measured at screening at least one week before the start of the study.
83367|NCT02064205|P1|Participant Flow|All Study Participants|"A: Breakfast with the pre-load and 12.5 g polydextrose B:Breakfast with the pre-load without polydextrose C: Breakfast and pre-load with 12.5 g polydextrose at 150 min D:Breakfast and pre-load without polydextrose at t=150 min~Eight orders:~A-B-D-C; B-C-A-D; C-D-B-A; D-A-C-B; A-D-B-C; C-B-D-A; B-A-C-D; D-C-A-B."
83368|NCT02064205|O2|Outcome|Glucose Syrup at Breakfast (Control) [B]|Breakfast with glucose syrup and yogurt provided four hours before lunch.
83369|NCT02064205|O1|Outcome|Polydextrose Syrup at Breakfast [A]|Breakfast with polydextrose and yogurt provided four hours before lunch.
83370|NCT02064205|O4|Outcome|Pre-load With Glucose Syrup Before Lunch [D]|Pre-load with glucose syrup and yogurt was provided 1.5h before lunch.
83371|NCT02064205|O3|Outcome|Pre-load With Polydextrose Before Lunch [C]|Pre-load with polydextrose syrup and yogurt is provided 1.5h before lunch
83372|NCT02064205|O2|Outcome|Glucose Syrup as Proload With Breakfast (Control) [B]|Breakfast with glucose syrup and yogurt provided four hours before lunch.
83373|NCT02064205|O1|Outcome|Polydextrose Syrup Preload With Yogurt With Breakfast [A]|Polydextrose syrup preload with yogurt with breakfast was consumed four hours before lunch
83374|NCT02064205|O4|Outcome|Pre-load With Yogurt and Glucose Before Lunch [D]|"Breakfast without pre-load. Pre-load with yogurt and glucose (control) provided 1.5h before lunch.~Yogurt with control (glucose syrup) is tested for its satiating effect 1.5h before lunch"
83375|NCT02064205|O3|Outcome|Pre-load With Polydextroseglucose Before Lunch [C]|"Breakfast without pre-load. Pre-load with yogurt and polydextrose provided 1.5h before lunch.~12.5 g polydextrose: Appetite suppressing supplement is added in yogurt 1.5h before lunch."
83376|NCT02064205|O2|Outcome|Glucose Syrup at Breakfast (Control) [B]|"Breakfast with control pre-load four hours before lunch~Yogurt with control (glucose syrup) is tested for its satiating effect.~glucose syrup: Glucose syrup is used a control product for the polydextrose"
83377|NCT02064205|O1|Outcome|Polydextrose Syrup at Breakfast [A]|"Breakfast with pre-load four hours before lunch~12.5 g polydextrose: Appetite suppressing supplement is added in yogurt and provided with breakfast, four hours before lunch."
83378|NCT02064205|E4|Reported Event|Condition D|Breakfast without preload; pre-load provided at t=150 min as a mid-morning snack of yogurt and glucose syrup
83379|NCT02064205|E3|Reported Event|Condition C|Breakfast without preload; pre-load provided at t=150 min as a mid-morning snack of yogurt and polydextrose
83380|NCT02064205|E2|Reported Event|Condition B|Breakfast with preload of yogurt and glucose control
83381|NCT02064205|E1|Reported Event|Condition A|Breakfast with preload of yogurt and polydextrose
83382|NCT02063880|B3|Baseline|Total|Total of all reporting groups
83383|NCT02063880|B2|Baseline|Early ART|"Initiation of HAART 7-14 days after enrollment.~Early ART: Children will be started on ART after stabilization 7-14 days after enrollment."
83384|NCT02063880|B1|Baseline|Urgent ART|"Initiation of highly active antiretroviral therapy (HAART) within 48 hours of enrollment.~Antiretroviral therapy will include regimens recommended by the Kenyan Ministry of Health.~Urgent ART: Children will be started on HAART <48 hours after enrollment."
83385|NCT02063880|P2|Participant Flow|Early ART|"Initiation of HAART 7-14 days after enrollment.~Early ART: Children will be started on ART after stabilization 7-14 days after enrollment."
84016|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
83387|NCT02063880|O2|Outcome|Early ART|"Initiation of HAART 7-14 days after enrollment.~Early ART: Children will be started on ART after stabilization 7-14 days after enrollment."
83388|NCT02063880|O1|Outcome|Urgent ART|"Initiation of highly active antiretroviral therapy (HAART) within 48 hours of enrollment.~Antiretroviral therapy will include regimens recommended by the Kenyan Ministry of Health.~Urgent ART: Children will be started on HAART <48 hours after enrollment."
83389|NCT02063880|O2|Outcome|Early ART|"Initiation of HAART 7-14 days after enrollment.~Early ART: Children will be started on ART after stabilization 7-14 days after enrollment."
83390|NCT02063880|O1|Outcome|Urgent ART|"Initiation of highly active antiretroviral therapy (HAART) within 48 hours of enrollment.~Antiretroviral therapy will include regimens recommended by the Kenyan Ministry of Health.~Urgent ART: Children will be started on HAART <48 hours after enrollment."
83391|NCT02063880|O2|Outcome|Early ART|"Initiation of HAART 7-14 days after enrollment.~Early ART: Children will be started on ART after stabilization 7-14 days after enrollment."
83392|NCT02063880|O1|Outcome|Urgent ART|"Initiation of highly active antiretroviral therapy (HAART) within 48 hours of enrollment.~Antiretroviral therapy will include regimens recommended by the Kenyan Ministry of Health.~Urgent ART: Children will be started on HAART <48 hours after enrollment."
83393|NCT02063880|E2|Reported Event|Early ART|"Initiation of HAART 7-14 days after enrollment.~Early ART: Children will be started on ART after stabilization 7-14 days after enrollment."
83394|NCT02063880|E1|Reported Event|Urgent ART|"Initiation of highly active antiretroviral therapy (HAART) within 48 hours of enrollment.~Antiretroviral therapy will include regimens recommended by the Kenyan Ministry of Health.~Urgent ART: Children will be started on HAART <48 hours after enrollment."
83395|NCT02063854|B8|Baseline|Total|Total of all reporting groups
83396|NCT02063854|B7|Baseline|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83397|NCT02063854|B6|Baseline|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83398|NCT02063854|B5|Baseline|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83399|NCT02063854|B4|Baseline|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83400|NCT02063854|B3|Baseline|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83401|NCT02063854|B2|Baseline|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83402|NCT02063854|B1|Baseline|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83403|NCT02063854|P7|Participant Flow|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83404|NCT02063854|P6|Participant Flow|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83405|NCT02063854|P5|Participant Flow|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83542|NCT02063672|O2|Outcome|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
84017|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
83406|NCT02063854|P4|Participant Flow|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83407|NCT02063854|P3|Participant Flow|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83408|NCT02063854|P2|Participant Flow|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83409|NCT02063854|P1|Participant Flow|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83410|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83411|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83412|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83413|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83414|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83415|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83416|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83417|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83418|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83419|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83502|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
83420|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83421|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83422|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83423|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83424|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83425|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83426|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83427|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83428|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83429|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83430|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83431|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83432|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83433|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83514|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
83434|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83435|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83436|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83437|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83438|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83439|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83440|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83441|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83442|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83443|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83444|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83445|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83446|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83447|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83533|NCT02063672|O1|Outcome|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
83534|NCT02063672|O2|Outcome|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
83448|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83449|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83450|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83451|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83452|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83453|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83454|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83455|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83456|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83457|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83458|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83459|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83460|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83461|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83535|NCT02063672|O1|Outcome|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
83536|NCT02063672|O2|Outcome|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
83462|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83463|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83464|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83465|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83466|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83467|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83468|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83469|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83470|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83471|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83472|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83473|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83474|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83475|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83537|NCT02063672|O1|Outcome|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
83538|NCT02063672|O2|Outcome|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
83476|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83477|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83478|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83479|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83480|NCT02063854|O3|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83481|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83482|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83483|NCT02063854|E7|Reported Event|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83484|NCT02063854|E6|Reported Event|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83485|NCT02063854|E5|Reported Event|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83486|NCT02063854|E4|Reported Event|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83487|NCT02063854|E3|Reported Event|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83488|NCT02063854|E2|Reported Event|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83489|NCT02063854|E1|Reported Event|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
83490|NCT02063737|B3|Baseline|Total|Total of all reporting groups
83539|NCT02063672|O1|Outcome|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
83491|NCT02063737|B2|Baseline|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
83492|NCT02063737|B1|Baseline|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
83493|NCT02063737|P2|Participant Flow|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
83494|NCT02063737|P1|Participant Flow|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
83495|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
83496|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
83497|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
83498|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
83499|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
83500|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
83501|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
83540|NCT02063672|O2|Outcome|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
83503|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
83504|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
83505|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
83506|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
83507|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
83508|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
83509|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
83510|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
83511|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
83512|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
83513|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
83541|NCT02063672|O1|Outcome|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
83543|NCT02063672|O1|Outcome|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
83515|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
83516|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
83517|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
83518|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
83519|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
83520|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
83521|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
83522|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
83523|NCT02063737|E2|Reported Event|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
83524|NCT02063737|E1|Reported Event|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
83525|NCT02063672|B3|Baseline|Total|Total of all reporting groups
83526|NCT02063672|B2|Baseline|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
83527|NCT02063672|B1|Baseline|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
83528|NCT02063672|P2|Participant Flow|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
83529|NCT02063672|P1|Participant Flow|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
83530|NCT02063672|O2|Outcome|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
83531|NCT02063672|O1|Outcome|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
83532|NCT02063672|O2|Outcome|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
83544|NCT02063672|O2|Outcome|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
83545|NCT02063672|O1|Outcome|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
83546|NCT02063672|O2|Outcome|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
83547|NCT02063672|O1|Outcome|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
83548|NCT02063672|O2|Outcome|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
83549|NCT02063672|O1|Outcome|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
83550|NCT02063672|O2|Outcome|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
83551|NCT02063672|O1|Outcome|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
83552|NCT02063672|O2|Outcome|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
83553|NCT02063672|O1|Outcome|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
83554|NCT02063672|O2|Outcome|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
83555|NCT02063672|O1|Outcome|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
83556|NCT02063672|O2|Outcome|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
83557|NCT02063672|O1|Outcome|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
83558|NCT02063672|O2|Outcome|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
83559|NCT02063672|O1|Outcome|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
83560|NCT02063672|O2|Outcome|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
83561|NCT02063672|O1|Outcome|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
83562|NCT02063672|O2|Outcome|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
83563|NCT02063672|O1|Outcome|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
83564|NCT02063672|O2|Outcome|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
83565|NCT02063672|O1|Outcome|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
83566|NCT02063672|O2|Outcome|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
83567|NCT02063672|O1|Outcome|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
83568|NCT02063672|O2|Outcome|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
83569|NCT02063672|O1|Outcome|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
83570|NCT02063672|E2|Reported Event|PTA Catheter|"Standard Uncoated Balloon Angioplasty Catheter~Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter"
83571|NCT02063672|E1|Reported Event|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
83572|NCT02063659|B4|Baseline|Total|Total of all reporting groups
83573|NCT02063659|B3|Baseline|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
83574|NCT02063659|B2|Baseline|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
83575|NCT02063659|B1|Baseline|Placebo|Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
83576|NCT02063659|P4|Participant Flow|Telotristat Etiprate Open-Label Extension|Patients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks.
83577|NCT02063659|P3|Participant Flow|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
83578|NCT02063659|P2|Participant Flow|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
83579|NCT02063659|P1|Participant Flow|Placebo|Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
83580|NCT02063659|O2|Outcome|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
83581|NCT02063659|O1|Outcome|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
83582|NCT02063659|O3|Outcome|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
83583|NCT02063659|O2|Outcome|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
83584|NCT02063659|O1|Outcome|Placebo|Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
83585|NCT02063659|O3|Outcome|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 Week double-blind treatment period, followed by a 36 week open-label extension period.
83586|NCT02063659|O2|Outcome|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 Weeks, followed by a 36 week open-label extension period.
83587|NCT02063659|O1|Outcome|Placebo|Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
83588|NCT02063659|O3|Outcome|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
83589|NCT02063659|O2|Outcome|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
83590|NCT02063659|O1|Outcome|Placebo|Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
83591|NCT02063659|O3|Outcome|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
83592|NCT02063659|O2|Outcome|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
83593|NCT02063659|O1|Outcome|Placebo|Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
83594|NCT02063659|O3|Outcome|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
83595|NCT02063659|O2|Outcome|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
83596|NCT02063659|O1|Outcome|Placebo|Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
83597|NCT02063659|O1|Outcome|Telotristat Etiprate Open-Label Extension|Patients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks.
83598|NCT02063659|O3|Outcome|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
83599|NCT02063659|O2|Outcome|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
83600|NCT02063659|O1|Outcome|Placebo|Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
83601|NCT02063659|O3|Outcome|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
83668|NCT02063217|E3|Reported Event|Control|Participant will sleep as normal under the same controlled conditions in a clinical research unit
83602|NCT02063659|O2|Outcome|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
83603|NCT02063659|O1|Outcome|Placebo|Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
83604|NCT02063659|E4|Reported Event|Telotristat Etiprate Open-Label Extension|Patients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks.
83605|NCT02063659|E3|Reported Event|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
83606|NCT02063659|E2|Reported Event|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
83607|NCT02063659|E1|Reported Event|Placebo|Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
83608|NCT02063516|B3|Baseline|Total|Total of all reporting groups
83609|NCT02063516|B2|Baseline|Proseal|"Device:Proseal Laryngeal Mask Airway~Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
83610|NCT02063516|B1|Baseline|Guardian|"Device: Guardian Laryngeal Mask~Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
83611|NCT02063516|P2|Participant Flow|Proseal|"Device:Proseal Laryngeal Mask Airway~Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
83612|NCT02063516|P1|Participant Flow|Guardian|"Device: Guardian Laryngeal Mask~Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
83613|NCT02063516|O2|Outcome|Proseal|"Device:Proseal Laryngeal Mask Airway~Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
83614|NCT02063516|O1|Outcome|Guardian|"Device: Guardian Laryngeal Mask~Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
83615|NCT02063516|O2|Outcome|Proseal|"Device:Proseal Laryngeal Mask Airway~Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
83616|NCT02063516|O1|Outcome|Guardian|"Device: Guardian Laryngeal Mask~Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
83617|NCT02063516|O2|Outcome|Proseal|"Device:Proseal Laryngeal Mask Airway~Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
83618|NCT02063516|O1|Outcome|Guardian|"Device: Guardian Laryngeal Mask~Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
83619|NCT02063516|E2|Reported Event|Proseal|"Device:Proseal Laryngeal Mask Airway~Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
83669|NCT02063217|E2|Reported Event|Sleep Deprivation|"Sleep deprivation for up to 36 hours with no naps or other sleep periods~Sleep deprivation: 36hr sleep deprivation"
84018|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
83620|NCT02063516|E1|Reported Event|Guardian|"Device: Guardian Laryngeal Mask~Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
83621|NCT02063230|B5|Baseline|Total|Total of all reporting groups
83622|NCT02063230|B4|Baseline|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
83623|NCT02063230|B3|Baseline|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
83624|NCT02063230|B2|Baseline|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
83625|NCT02063230|B1|Baseline|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
83626|NCT02063230|P4|Participant Flow|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
83627|NCT02063230|P3|Participant Flow|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
83628|NCT02063230|P2|Participant Flow|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
83629|NCT02063230|P1|Participant Flow|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
83630|NCT02063230|O4|Outcome|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
83631|NCT02063230|O3|Outcome|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
83632|NCT02063230|O2|Outcome|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
83633|NCT02063230|O1|Outcome|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
83634|NCT02063230|O4|Outcome|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
83635|NCT02063230|O3|Outcome|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
83636|NCT02063230|O2|Outcome|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
83637|NCT02063230|O1|Outcome|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
83638|NCT02063230|O4|Outcome|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
83639|NCT02063230|O3|Outcome|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
83640|NCT02063230|O2|Outcome|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
83641|NCT02063230|O1|Outcome|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
83642|NCT02063230|O4|Outcome|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
83643|NCT02063230|O3|Outcome|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
83644|NCT02063230|O2|Outcome|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
83645|NCT02063230|O1|Outcome|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
83646|NCT02063230|O4|Outcome|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
83647|NCT02063230|O3|Outcome|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
83648|NCT02063230|O2|Outcome|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
83649|NCT02063230|O1|Outcome|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
83650|NCT02063230|O4|Outcome|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
83651|NCT02063230|O3|Outcome|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
83652|NCT02063230|O2|Outcome|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
83653|NCT02063230|O1|Outcome|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
83654|NCT02063230|E4|Reported Event|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
83655|NCT02063230|E3|Reported Event|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
83656|NCT02063230|E2|Reported Event|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
83657|NCT02063230|E1|Reported Event|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
83658|NCT02063217|B4|Baseline|Total|Total of all reporting groups
83659|NCT02063217|B3|Baseline|Control|Participant will sleep as normal under the same controlled conditions in a clinical research unit
83660|NCT02063217|B2|Baseline|Sleep Deprivation|"Sleep deprivation for up to 36 hours with no naps or other sleep periods~Sleep deprivation: 36hr sleep deprivation"
83661|NCT02063217|B1|Baseline|Sleep Induction|"6.5-7.5 grams of sodium oxybate~Sodium Oxybate: Sodium oxybate h.s."
83662|NCT02063217|P3|Participant Flow|Control|Participant will sleep as normal under the same controlled conditions in a clinical research unit
83663|NCT02063217|P2|Participant Flow|Sleep Deprivation|"Sleep deprivation for up to 36 hours with no naps or other sleep periods~Sleep deprivation: 36hr sleep deprivation"
83664|NCT02063217|P1|Participant Flow|Sleep Induction|"6.5-7.5 grams of sodium oxybate~Sodium Oxybate: Sodium oxybate h.s."
83665|NCT02063217|O3|Outcome|Control|Participant will sleep as normal under the same controlled conditions in a clinical research unit
83666|NCT02063217|O2|Outcome|Sleep Deprivation|"Sleep deprivation for up to 36 hours with no naps or other sleep periods~Sleep deprivation: 36hr sleep deprivation"
83667|NCT02063217|O1|Outcome|Sleep Induction|"6.5-7.5 grams of sodium oxybate~Sodium Oxybate: Sodium oxybate h.s."
83672|NCT02063035|B2|Baseline|Placebo|Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
83673|NCT02063035|B1|Baseline|Tranexamic Acid|Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
83674|NCT02063035|P2|Participant Flow|Placebo|Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
83675|NCT02063035|P1|Participant Flow|Tranexamic Acid|Participants undergoing spinal surgery received a single, topical dose of 3 grams (g) tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
83676|NCT02063035|O2|Outcome|Placebo|Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
83677|NCT02063035|O1|Outcome|Tranexamic Acid|Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
83678|NCT02063035|O2|Outcome|Placebo|Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
83679|NCT02063035|O1|Outcome|Tranexamic Acid|Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
83680|NCT02063035|O2|Outcome|Placebo|Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
83681|NCT02063035|O1|Outcome|Tranexamic Acid|Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
83682|NCT02063035|O2|Outcome|Placebo|Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
83683|NCT02063035|O1|Outcome|Tranexamic Acid|Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
83684|NCT02063035|E2|Reported Event|Placebo|Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
83685|NCT02063035|E1|Reported Event|Tranexamic Acid|Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
83686|NCT02062905|B3|Baseline|Total|Total of all reporting groups
83687|NCT02062905|B2|Baseline|Placebo Plug Delivery Vehicle|"Placebo Plug with no drug~Placebo Plug with no drug"
83688|NCT02062905|B1|Baseline|OTX-DP Treatment|"OTX-DP (sustained release dexamethasone, 0.4 mg)~OTX-DP treatment"
83689|NCT02062905|P2|Participant Flow|Placebo Plug Delivery Vehicle|"Placebo Plug with no drug~Placebo Plug with no drug"
83690|NCT02062905|P1|Participant Flow|OTX-DP Treatment|"OTX-DP (sustained release dexamethasone, 0.4 mg)~OTX-DP treatment"
83691|NCT02062905|O2|Outcome|Placebo Plug Delivery Vehicle|"Placebo Plug with no drug~Placebo Plug with no drug"
83692|NCT02062905|O1|Outcome|OTX-DP Treatment|"OTX-DP (sustained release dexamethasone, 0.4 mg)~OTX-DP treatment"
83693|NCT02062905|O2|Outcome|Placebo Plug Delivery Vehicle|"Placebo Plug with no drug~Placebo Plug with no drug"
83694|NCT02062905|O1|Outcome|OTX-DP Treatment|"OTX-DP (sustained release dexamethasone, 0.4 mg)~OTX-DP treatment"
83695|NCT02062905|E2|Reported Event|Placebo Plug Delivery Vehicle|"Placebo Plug with no drug~Placebo Plug with no drug"
83696|NCT02062905|E1|Reported Event|OTX-DP Treatment|"OTX-DP (sustained release dexamethasone, 0.4 mg)~OTX-DP treatment"
83697|NCT02062879|B3|Baseline|Total|Total of all reporting groups
83698|NCT02062879|B2|Baseline|Hydromorphone|"Hydromorphone 6mg/30 mL PCA (0.2 mg/mL)~Hydromorphone: Hydromorphone administered as patient-controlled analgesia."
83699|NCT02062879|B1|Baseline|Ketamine|"Ketamine 90mg/30 mL PCA (3 mg/mL)~Ketamine: Ketamine administered as patient-controlled analgesia."
83700|NCT02062879|P2|Participant Flow|Hydromorphone|"Hydromorphone 6mg/30 mL PCA (0.2 mg/mL)~Hydromorphone: Hydromorphone administered as patient-controlled analgesia."
83701|NCT02062879|P1|Participant Flow|Ketamine|"Ketamine 90mg/30 mL PCA (3 mg/mL)~Ketamine: Ketamine administered as patient-controlled analgesia."
83702|NCT02062879|O2|Outcome|Hydromorphone|"Hydromorphone 6mg/30 mL PCA (0.2 mg/mL)~Hydromorphone: Hydromorphone administered as patient-controlled analgesia."
83703|NCT02062879|O1|Outcome|Ketamine|"Ketamine 90mg/30 mL PCA (3 mg/mL)~Ketamine: Ketamine administered as patient-controlled analgesia."
83704|NCT02062879|O2|Outcome|Hydromorphone|"Hydromorphone 6mg/30 mL PCA (0.2 mg/mL)~Hydromorphone: Hydromorphone administered as patient-controlled analgesia."
83705|NCT02062879|O1|Outcome|Ketamine|"Ketamine 90mg/30 mL PCA (3 mg/mL)~Ketamine: Ketamine administered as patient-controlled analgesia."
83706|NCT02062879|O2|Outcome|Hydromorphone|"Hydromorphone 6mg/30 mL PCA (0.2 mg/mL)~Hydromorphone: Hydromorphone administered as patient-controlled analgesia."
83707|NCT02062879|O1|Outcome|Ketamine|"Ketamine 90mg/30 mL PCA (3 mg/mL)~Ketamine: Ketamine administered as patient-controlled analgesia."
83708|NCT02062879|E2|Reported Event|Hydromorphone|"Hydromorphone 6mg/30 mL PCA (0.2 mg/mL)~Hydromorphone: Hydromorphone administered as patient-controlled analgesia."
83709|NCT02062879|E1|Reported Event|Ketamine|"Ketamine 90mg/30 mL PCA (3 mg/mL)~Ketamine: Ketamine administered as patient-controlled analgesia."
83710|NCT02062801|B3|Baseline|Total|Total of all reporting groups
83711|NCT02062801|B2|Baseline|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion~Placebo"
83712|NCT02062801|B1|Baseline|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion~Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
83713|NCT02062801|P2|Participant Flow|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion~Placebo"
83714|NCT02062801|P1|Participant Flow|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion~Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
83715|NCT02062801|O2|Outcome|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion~Placebo"
83716|NCT02062801|O1|Outcome|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion~Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
83717|NCT02062801|O2|Outcome|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion~Placebo"
83718|NCT02062801|O1|Outcome|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion~Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
83719|NCT02062801|O2|Outcome|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion~Placebo"
83720|NCT02062801|O1|Outcome|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion~Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
83721|NCT02062801|E2|Reported Event|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion~Placebo"
83722|NCT02062801|E1|Reported Event|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion~Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
83723|NCT02062710|B1|Baseline|Diphenhydramine/Phenylephrine/Cocoa, Dextromethorphan,Placebo|"Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup; dextromethorphan; placebo.~Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.~Phenylephrine: 10 mg dose phenylephrine~Diphenhydramine: 25 mg dose diphenhydramine~Dextromethorphan: 30 mg dose dextromethorphan"
83724|NCT02062710|P6|Participant Flow|Placebo, Dextromethorphan, Then Diphenhydramine/Phenylephrine/|"placebo, then dextromethorphan 30 mg, then diphenhydramine 25 mg and phenylephrine 10 mg.~Intervention: capsaicin cough challenge 2 hours after study drug administration.~Washout period 1-2 days after each of the 3 dosing periods."
83725|NCT02062710|P5|Participant Flow|Placebo, Diphenhydramine/Phenylephrine/Cocoa, Then Dextrometho|"placebo, then diphenhydramine 25 mg and phenylephrine 10 mg, then dextromethorphan 30 mg.~Intervention: capsaicin cough challenge 2 hours after study drug administration.~Washout period 1-2 days after each of the 3 dosing periods"
83726|NCT02062710|P4|Participant Flow|Dextromethorphan, Placebo, Then Diphenhydramine/Phenylephrine/|"dextromethorphan 30 mg, then placebo, then diphenhydramine 25 mg and phenylephrine 10 mg.~Intervention: capsaicin cough challenge 2 hours after study drug ingestion. Washout period 1-2 days between each of the 3 dosing periods"
83727|NCT02062710|P3|Participant Flow|Dextromethorphan, Diphenhydramine/Phenylephrine/Cocoa, Then pl|dextromethorphan 30 mg, then diphenhydramine/phenylephrine/cocoa, then placebo. Intervention: capsaicin cough challeneg 2 hours after study drug ingestion
83728|NCT02062710|P2|Participant Flow|Diphenhydramine/Phenylephrine/Cocoa, Then Placebo, Then Dextro|"diphenhydramine 25 mg and phenylephrine 10 mg; then placebo; then dextromethorphan 30 mg.~Intervention: capsaicin cough challenge testing after study drug ingestion"
83729|NCT02062710|P1|Participant Flow|Diphenhydramine/Phen/Cocoa, Dextromethorphan, Then Placebo|"Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup; then dextromethorphan 30 mg; then placebo.~Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.~Washout 1-2 days between each of the 3 dosing periods."
83730|NCT02062710|O3|Outcome|Placebo|placebo liquid, dextrose in water, 20 mL
83731|NCT02062710|O2|Outcome|Dextromethorphan|"Dextromethorphan syrup, 30 mg dose. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.~Dextromethorphan: 30 mg dose dextromethorphan"
83732|NCT02062710|O1|Outcome|Diphenhydramine/Phenylephrine/Cocoa|"Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.~Phenylephrine: 10 mg dose phenylephrine~Diphenhydramine: 25 mg dose diphenhydramine"
83733|NCT02062710|E3|Reported Event|Placebo|placebo liquid, dextrose in water, 20 mL
83734|NCT02062710|E2|Reported Event|Dextromethorphan|"Dextromethorphan syrup, 30 mg dose. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.~Dextromethorphan: 30 mg dose dextromethorphan"
83735|NCT02062710|E1|Reported Event|Diphenhydramine/Phenylephrine/Cocoa|"Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.~Phenylephrine: 10 mg dose phenylephrine~Diphenhydramine: 25 mg dose diphenhydramine"
83736|NCT02062658|B1|Baseline|Ketamine, Exposure & Response Prevention|"0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)~Ketamine: 0.5mg/kg IV~Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention."
83737|NCT02062658|P1|Participant Flow|Ketamine, Exposure & Response Prevention|"0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)~Ketamine: 0.5mg/kg IV~Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention."
83738|NCT02062658|O1|Outcome|Ketamine, Exposure & Response Prevention|"0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)~Ketamine: 0.5mg/kg IV~Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention."
83739|NCT02062658|E1|Reported Event|Ketamine, Exposure & Response Prevention|"0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)~Ketamine: 0.5mg/kg IV~Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention."
83740|NCT02062645|B1|Baseline|Amlodipine/Valsartan|All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
83741|NCT02062645|P1|Participant Flow|Amlodipine/Valsartan|All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
83742|NCT02062645|O1|Outcome|Amlodipine/Valsartan|All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
83743|NCT02062645|O1|Outcome|Amlodipine/Valsartan|All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
83744|NCT02062645|O1|Outcome|Amlodipine/Valsartan|All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
83745|NCT02062645|O1|Outcome|Amlodipine/Valsartan|All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
83746|NCT02062645|O1|Outcome|Amlodipine/Valsartan|All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
83747|NCT02062645|E1|Reported Event|Amlodipine/Valsartan|amlodipine/valsartan
83748|NCT02062580|B3|Baseline|Total|Total of all reporting groups
83749|NCT02062580|B2|Baseline|Early BCG|"BCG at birth; standard of care~BCG"
83750|NCT02062580|B1|Baseline|Delayed BCG|"BCG delayed to 8 weeks of age~BCG"
83751|NCT02062580|P2|Participant Flow|Early BCG|"BCG at birth; standard of care~BCG"
83752|NCT02062580|P1|Participant Flow|Delayed BCG|"BCG delayed to 8 weeks of age~BCG"
83753|NCT02062580|O2|Outcome|Early BCG|"BCG at birth; standard of care~BCG"
83754|NCT02062580|O1|Outcome|Delayed BCG|"BCG delayed to 8 weeks of age~BCG"
83755|NCT02062580|O2|Outcome|Early BCG|"BCG at birth; standard of care~BCG"
83756|NCT02062580|O1|Outcome|Delayed BCG|"BCG delayed to 8 weeks of age~BCG"
83757|NCT02062580|E2|Reported Event|Early BCG|"BCG at birth; standard of care~BCG"
83758|NCT02062580|E1|Reported Event|Delayed BCG|"BCG delayed to 8 weeks of age~BCG"
83759|NCT02062502|B3|Baseline|Total|Total of all reporting groups
83760|NCT02062502|B2|Baseline|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
83761|NCT02062502|B1|Baseline|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
83762|NCT02062502|P2|Participant Flow|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
83763|NCT02062502|P1|Participant Flow|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
83764|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
83765|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
83766|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
83767|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
83768|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
83769|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
83770|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
83771|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
84019|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
84020|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
83772|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
83773|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
83774|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
83775|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
83776|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
83777|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
83778|NCT02062502|E2|Reported Event|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
83779|NCT02062502|E1|Reported Event|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
83780|NCT02062450|B3|Baseline|Total|Total of all reporting groups
83781|NCT02062450|B2|Baseline|Revision Surgery|Patients who underwent a revision hip replacement surgery with Dual Mobility Cup
83782|NCT02062450|B1|Baseline|Primary Surgery|Patients who underwent a primary hip replacement surgery with Dual Mobility Cup
83783|NCT02062450|P1|Participant Flow|Hip Acetabular Replacement, Using a Dual Mobility Cup.|"Studied cohort includes 2 subgroups :~Patients with primary hip replacement.~Patients with revision surgery."
83784|NCT02062450|O1|Outcome|Total Safety Population|All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
83785|NCT02062450|O2|Outcome|Revision Sub-group|patients who undergone a revision hip replacement surgery
83786|NCT02062450|O1|Outcome|Primary Surgery Sub-group|Patients who undergone a primary hip replacement surgery
83787|NCT02062450|O2|Outcome|Revision Sub-group|patients who undergone a revision hip replacement surgery
83788|NCT02062450|O1|Outcome|Primary Surgery Sub-group|Patients who undergone a primary hip replacement surgery
83789|NCT02062450|O2|Outcome|Revision Sub-group|patients who undergone a revision hip replacement surgery
83790|NCT02062450|O1|Outcome|Primary Surgery Sub-group|Patients who undergone a primary hip replacement surgery
83791|NCT02062450|O1|Outcome|Total Safety Population|All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
83792|NCT02062450|O1|Outcome|Total Safety Population|All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
83793|NCT02062450|E3|Reported Event|Revision Surgery Sub-group|Patients who underwent a Revision Hip Replacement surgery
83794|NCT02062450|E2|Reported Event|Primary Surgery Sub-group|Patients who underwent a Primary Hip Replacement surgery
83795|NCT02062450|E1|Reported Event|Total Safety Population|All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
83796|NCT02062437|B1|Baseline|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
83797|NCT02062437|P1|Participant Flow|Total Hip Replacement Using a Ceramic Friction Pair|All patients were treated with a total hip replacement using a ceramic friction pair Biolox® delta, with a Meije Duo® cementless stem with HAP associated with a cementless double coating of plasma sprayed titanium and HAP Dynacup® acetabular cup.
83798|NCT02062437|O1|Outcome|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
83799|NCT02062437|O1|Outcome|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
83800|NCT02062437|O1|Outcome|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
83801|NCT02062437|O1|Outcome|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
83802|NCT02062437|O1|Outcome|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
83803|NCT02062437|O1|Outcome|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
83804|NCT02062437|E1|Reported Event|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
83805|NCT02062385|B5|Baseline|Total|Total of all reporting groups
83806|NCT02062385|B4|Baseline|Placebo With Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
83807|NCT02062385|B3|Baseline|V260 With Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
84021|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
83808|NCT02062385|B2|Baseline|Placebo With Staggered EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months.
83809|NCT02062385|B1|Baseline|V260 With Staggered EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months.
83810|NCT02062385|P4|Participant Flow|Placebo With Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
83811|NCT02062385|P3|Participant Flow|V260 With Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
83812|NCT02062385|P2|Participant Flow|Placebo With Staggered EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months.
83813|NCT02062385|P1|Participant Flow|V260 With Staggered EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered China Expanded Program on Immunization (EPI) as follows: Oral poliovirus vaccine (OPV) administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and diphtheria, tetanus, acellular pertussis vaccine (DTaP) administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months.
83814|NCT02062385|O2|Outcome|Placebo With Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
83815|NCT02062385|O1|Outcome|V260 With Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
83816|NCT02062385|O2|Outcome|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
83817|NCT02062385|O1|Outcome|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
83818|NCT02062385|O2|Outcome|Placebo With Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
83819|NCT02062385|O1|Outcome|V260 With Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
83820|NCT02062385|O2|Outcome|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
83821|NCT02062385|O1|Outcome|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
83822|NCT02062385|O2|Outcome|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
83823|NCT02062385|O1|Outcome|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
83824|NCT02062385|O2|Outcome|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
83825|NCT02062385|O1|Outcome|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
83826|NCT02062385|O2|Outcome|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
83827|NCT02062385|O1|Outcome|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
83828|NCT02062385|O2|Outcome|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
83829|NCT02062385|O1|Outcome|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
83830|NCT02062385|E2|Reported Event|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
83831|NCT02062385|E1|Reported Event|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
83832|NCT02062359|B1|Baseline|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.~On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: On days"
83833|NCT02062359|P1|Participant Flow|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.~On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: On days"
83834|NCT02062359|O1|Outcome|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.~On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: On days"
83835|NCT02062359|O1|Outcome|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.~On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: On days"
83864|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83865|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83836|NCT02062359|O1|Outcome|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.~On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: On days"
83837|NCT02062359|E1|Reported Event|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.~On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: On days"
83838|NCT02062294|B1|Baseline|Valganciclovir|Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
83839|NCT02062294|P1|Participant Flow|Valganciclovir|Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
83840|NCT02062294|O1|Outcome|Valganciclovir|Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
83841|NCT02062294|O1|Outcome|Valganciclovir|Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
83842|NCT02062294|E1|Reported Event|Valganciclovir|Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
83843|NCT02062177|B3|Baseline|Total|Total of all reporting groups
83844|NCT02062177|B2|Baseline|Midazolam Group|"70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with midazolam (0.04 mg/kg if aged <70 years - 0.03 mg/kg if aged >70 years).~35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control."
83845|NCT02062177|B1|Baseline|Propofol Group|"70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with propofol TCI (Target Controlled Infusion) pump. Target concentration was initially set at 1.2-1.6 µg/ml according to patient’s body weight and general condition.~35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control.~Patients in this group received placebo boluses with normal saline to warrant blindness to the randomization group of both patient and endoscopist. (because of the well-known difference in the physical appearance of the study drugs, to maintain blindness of endoscopist, a fabric curtain was drawn across patient’s arm covering the i.v. line and TCI pump)."
83846|NCT02062177|P2|Participant Flow|Midazolam Group|"A total amount of 70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with midazolam (0.04 mg/kg if aged <70 years - 0.03 mg/kg if aged >70 years).~35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control."
83847|NCT02062177|P1|Participant Flow|Propofol Group|"A total amount of 70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with propofol TCI (Target Controlled Infusion) pump. Target concentration was initially set at 1.2-1.6 µg/ml according to patient’s body weight and general condition.~35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control."
83848|NCT02062177|O2|Outcome|Midazolam Group; n=35, 35|
83849|NCT02062177|O1|Outcome|Propofol Group; n=35, 35|
83850|NCT02062177|O2|Outcome|Midazolam Group; n=35, 35|
83851|NCT02062177|O1|Outcome|Propofol Group; n=35, 35|
83852|NCT02062177|O2|Outcome|Midazolam Group; n=35, 35|
83853|NCT02062177|O1|Outcome|Propofol Group; n=35, 35|
83854|NCT02062177|E2|Reported Event|Midazolam Group; n=35, 35|35 upper endoscopy 35 colonoscopy
83855|NCT02062177|E1|Reported Event|Propofol Group; n=35, 35|35 upper endoscopy 35 colonoscopy
83856|NCT02061748|B3|Baseline|Total|Total of all reporting groups
83857|NCT02061748|B2|Baseline|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83858|NCT02061748|B1|Baseline|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83859|NCT02061748|P2|Participant Flow|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83860|NCT02061748|P1|Participant Flow|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83861|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83862|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83863|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83993|NCT02061358|B8|Baseline|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
83866|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83867|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83868|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83869|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83870|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83871|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83872|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83873|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83874|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83875|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83876|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83877|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83878|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83879|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83880|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83881|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83882|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83883|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83884|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83885|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83886|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83887|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83888|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83889|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83890|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83891|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83892|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83893|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83894|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83895|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83994|NCT02061358|B7|Baseline|720 mg UV-4B|UV-4B 720 mg oral, single dose
83896|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83897|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83898|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83899|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83900|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83901|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83902|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83903|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83904|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83905|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83906|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83907|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83908|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83909|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83910|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83911|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83912|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83913|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83914|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83915|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83916|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83917|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83918|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83919|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83920|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83921|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83922|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83923|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83924|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83925|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83995|NCT02061358|B6|Baseline|360 mg UV-4B|UV-4B 360 mg oral, single dose
83926|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83927|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83928|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83929|NCT02061748|E2|Reported Event|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
83930|NCT02061748|E1|Reported Event|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
83931|NCT02061696|B3|Baseline|Total|Total of all reporting groups
83932|NCT02061696|B2|Baseline|AXERA 2 Access System|"The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.~Vascular Access Device: AXERA 2 Access System with Reduced Manual Compression"
83933|NCT02061696|B1|Baseline|Standard Manual Compression|"Standard manual compression at the access site applied as per standard of care protocol for sheath removal.~Standard Manual Compression: Closure procedure by Manual Compression"
83934|NCT02061696|P2|Participant Flow|AXERA 2 Access System|"The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.~Vascular Access Device: AXERA 2 Access System with Reduced Manual Compression"
83935|NCT02061696|P1|Participant Flow|Standard Manual Compression|"Standard manual compression at the access site applied as per standard of care protocol for sheath removal.~Standard Manual Compression: Closure procedure by Manual Compression"
83936|NCT02061696|O2|Outcome|AXERA 2 Access System|"The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.~Vascular Access Device: AXERA 2 Access System with Reduced Manual Compression"
83937|NCT02061696|O1|Outcome|Standard Manual Compression|"Standard manual compression at the access site applied as per standard of care protocol for sheath removal.~Standard Manual Compression: Closure procedure by Manual Compression"
83938|NCT02061696|O2|Outcome|AXERA 2 Access System|"The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.~Vascular Access Device: AXERA 2 Access System with Reduced Manual Compression"
83939|NCT02061696|O1|Outcome|Standard Manual Compression|"Standard manual compression at the access site applied as per standard of care protocol for sheath removal.~Standard Manual Compression: Closure procedure by Manual Compression"
83940|NCT02061696|O2|Outcome|AXERA 2 Access System|"The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.~Vascular Access Device: AXERA 2 Access System with Reduced Manual Compression"
83941|NCT02061696|O1|Outcome|Standard Manual Compression|"Standard manual compression at the access site applied as per standard of care protocol for sheath removal.~Standard Manual Compression: Closure procedure by Manual Compression"
83942|NCT02061696|O2|Outcome|AXERA 2 Access System|"The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.~Vascular Access Device: AXERA 2 Access System with Reduced Manual Compression"
83943|NCT02061696|O1|Outcome|Standard Manual Compression|"Standard manual compression at the access site applied as per standard of care protocol for sheath removal.~Standard Manual Compression: Closure procedure by Manual Compression"
83944|NCT02061696|O2|Outcome|AXERA 2 Access System|"The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.~Vascular Access Device: AXERA 2 Access System with Reduced Manual Compression"
83945|NCT02061696|O1|Outcome|Standard Manual Compression|"Standard manual compression at the access site applied as per standard of care protocol for sheath removal.~Standard Manual Compression: Closure procedure by Manual Compression"
83946|NCT02061696|O2|Outcome|AXERA 2 Access System|"The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.~Vascular Access Device: AXERA 2 Access System with Reduced Manual Compression"
83947|NCT02061696|O1|Outcome|Standard Manual Compression|"Standard manual compression at the access site applied as per standard of care protocol for sheath removal.~Standard Manual Compression: Closure procedure by Manual Compression"
83948|NCT02061696|O2|Outcome|AXERA 2 Access System|"The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.~Vascular Access Device: AXERA 2 Access System with Reduced Manual Compression"
83949|NCT02061696|O1|Outcome|Standard Manual Compression|"Standard manual compression at the access site applied as per standard of care protocol for sheath removal.~Standard Manual Compression: Closure procedure by Manual Compression"
83950|NCT02061696|O2|Outcome|AXERA 2 Access System|"The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.~Vascular Access Device: AXERA 2 Access System with Reduced Manual Compression"
83951|NCT02061696|O1|Outcome|Standard Manual Compression|"Standard manual compression at the access site applied as per standard of care protocol for sheath removal.~Standard Manual Compression: Closure procedure by Manual Compression"
83952|NCT02061696|O2|Outcome|AXERA 2 Access System|"The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.~Vascular Access Device: AXERA 2 Access System with Reduced Manual Compression"
83953|NCT02061696|O1|Outcome|Standard Manual Compression|"Standard manual compression at the access site applied as per standard of care protocol for sheath removal.~Standard Manual Compression: Closure procedure by Manual Compression"
83954|NCT02061696|O2|Outcome|AXERA 2 Access System|"The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.~Vascular Access Device: AXERA 2 Access System with Reduced Manual Compression"
83955|NCT02061696|O1|Outcome|Standard Manual Compression|"Standard manual compression at the access site applied as per standard of care protocol for sheath removal.~Standard Manual Compression: Closure procedure by Manual Compression"
83956|NCT02061696|E2|Reported Event|AXERA 2 Access System|"The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.~Vascular Access Device: AXERA 2 Access System with Reduced Manual Compression"
83957|NCT02061696|E1|Reported Event|Standard Manual Compression|"Standard manual compression at the access site applied as per standard of care protocol for sheath removal.~Standard Manual Compression: Closure procedure by Manual Compression"
83958|NCT02061683|B1|Baseline|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
83959|NCT02061683|P1|Participant Flow|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
83960|NCT02061683|O1|Outcome|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
83961|NCT02061683|O1|Outcome|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
83962|NCT02061683|E1|Reported Event|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
83963|NCT02061592|B3|Baseline|Total|Total of all reporting groups
83964|NCT02061592|B2|Baseline|Test/Control|Subjects first received the test lens, etafilcon A , for 1 week which was to be worn for a minimum of 8 hours per day. Subjects then returned for follow-up and were immediately dispensed the control lens, etafilcon A
83965|NCT02061592|B1|Baseline|Control/Test|Subjects first received the control lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. After 1 week subjects returned for follow-up and were immediately dispensed the test lens, etafilcon A.
83966|NCT02061592|P2|Participant Flow|Test/Control|Subjects first received the test lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. Subjects then returned for follow-up and were immediately dispensed the control lens, etafilcon A
83967|NCT02061592|P1|Participant Flow|Control/Test|Subjects first received the control lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. After 1 week subjects returned for follow-up and were immediately dispensed the test lens, etafilcon A.
83968|NCT02061592|O2|Outcome|Test|Subjects who received Test lens, etafilcon A , in either the first week or last week of the study.
83969|NCT02061592|O1|Outcome|Control|Subjects who received Control lens, etafilcon A, in either the first week or last week of the study.
83970|NCT02061592|O2|Outcome|Test|Subjects who received the Test lens, etafilcon A, in either the first week or last week of the study.
83971|NCT02061592|O1|Outcome|Control|Subjects who received Control lens, etafilcon A, in either the first week or last week of the study.
83972|NCT02061592|O2|Outcome|Test|Subjects who received Test lens, etafilcon A, in either the first week or last week of the study.
83973|NCT02061592|O1|Outcome|Control|Subjects who received Control lens, etafilcon A, in either the first week or last week of the study.
83974|NCT02061592|O2|Outcome|Test|Subjects who received the Test lens, etafilcon A, in either the first week or last week of the study.
83975|NCT02061592|O1|Outcome|Control|Subjects who received Control lens, etafilcon A, in either the first week or last week of the study.
83976|NCT02061592|E2|Reported Event|Test|Subjects who received the test lens, etafilcon A, in either the first week or the last week of the study.
83977|NCT02061592|E1|Reported Event|Control|Subjects who received control lens etafilcon A in either the first or the last week of the study .
83978|NCT02061540|B1|Baseline|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
83979|NCT02061540|P1|Participant Flow|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
83980|NCT02061540|O1|Outcome|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
83981|NCT02061540|O1|Outcome|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
83982|NCT02061540|O1|Outcome|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
83983|NCT02061540|O1|Outcome|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
83984|NCT02061540|O1|Outcome|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
83985|NCT02061540|O5|Outcome|Maralixibat (LUM001) 10 mg|Participants received LUM001 tablet orally once daily at a dose of 10 mg during Week 6 of the treatment period followed by stable dosing of 10 mg for 8 weeks.
83986|NCT02061540|O4|Outcome|Maralixibat (LUM001) 7.5 mg|Participants received LUM001 tablet orally once daily at a dose of 7.5 mg during Week 5 of the treatment period.
83987|NCT02061540|O3|Outcome|Maralixibat (LUM001) 5 mg|Participants received LUM001 tablet orally once daily at a dose of 5 mg during Week 4 of the treatment period.
83988|NCT02061540|O2|Outcome|Maralixibat (LUM001) 2.5 mg|Participants received LUM001 tablet orally once daily at a dose of 2.5 mg during Week 3 of the treatment period.
83989|NCT02061540|O1|Outcome|Maralixibat (LUM001) 1 mg|Participants received LUM001 tablet orally once daily at a dose of 1 mg during Week 2 of the treatment period.
83990|NCT02061540|E1|Reported Event|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
83991|NCT02061358|B10|Baseline|Total|Total of all reporting groups
83992|NCT02061358|B9|Baseline|Placebo|Placebo oral, single dose
84026|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
84027|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
84028|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
84029|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
84030|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
84031|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
84032|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
84033|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
84034|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
84035|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
84036|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
84037|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
84038|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
84039|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
84040|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
84041|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
84042|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
84043|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
84044|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
84045|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
84046|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
84047|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
84048|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
84049|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
84050|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
84051|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
84052|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
84053|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
84054|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
84055|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
84056|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
84057|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
84058|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
84059|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
84060|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
84061|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
84062|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
84063|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
84064|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
84065|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
84066|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
84067|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
84068|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
84069|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
84070|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
84071|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
84072|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
84073|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
84074|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
84075|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
84076|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
84077|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
84078|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
84079|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
84080|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
84081|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
84082|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
84083|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
84084|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
84085|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
84086|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
84087|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
84088|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
84089|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
84090|NCT02061358|O9|Outcome|Placebo|Placebo oral, single dose
84091|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
84092|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
84093|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
84094|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
84095|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
84096|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
84097|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
84098|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
84099|NCT02061358|O9|Outcome|Placebo|Placebo oral, single dose
84100|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
84101|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
84102|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
84103|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
84104|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
84105|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
84106|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
84109|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
84110|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
84111|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
84112|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
84113|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
84114|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
84115|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
84116|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
84117|NCT02061358|O9|Outcome|Placebo|Placebo oral, single dose
84118|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
84119|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
84120|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
84121|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
84122|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
84123|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
84124|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
84125|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
84126|NCT02061358|O9|Outcome|Placebo|Placebo oral, single dose
84127|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
84128|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
84129|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
84130|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
84131|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
84132|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
84133|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
84134|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
84135|NCT02061358|E9|Reported Event|Placebo|Placebo oral, single dose
84136|NCT02061358|E8|Reported Event|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
84137|NCT02061358|E7|Reported Event|720 mg UV-4B|UV-4B 720 mg oral, single dose
84138|NCT02061358|E6|Reported Event|360 mg UV-4B|UV-4B 360 mg oral, single dose
84139|NCT02061358|E5|Reported Event|180 mg UV-4B|UV-4B 180 mg oral, single dose
84140|NCT02061358|E4|Reported Event|90 mg UV-4B|UV-4B 90 mg oral, single dose
84141|NCT02061358|E3|Reported Event|30 mg UV-4B|UV-4B 30 mg oral, single dose
84142|NCT02061358|E2|Reported Event|10 mg UV-4B|UV-4B 10 mg oral, single dose
84143|NCT02061358|E1|Reported Event|3 mg UV-4B|UV-4B 3 mg oral, single dose
84144|NCT02061280|B3|Baseline|Total|Total of all reporting groups
84145|NCT02061280|B2|Baseline|LASST Trial Design|"Participants randomized to LASST will complete study procedures in the traditional format in which all study visits are conducted at the study site, all questionnaires are completed by pen/paper, and all spirometry is performed at the clinic site.~Randomized to one of 3 study treatments:~fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily"
84146|NCT02061280|B1|Baseline|MICT Trial Design|"Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.~Randomized to one of 3 study treatments:~fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily"
84147|NCT02061280|P2|Participant Flow|LASST Trial Design|"Participants randomized to LASST will complete study procedures in the traditional format in which all study visits are conducted at the study site, all questionnaires are completed by pen/paper, and all spirometry is performed at the clinic site.~Randomized to one of 3 study treatments:~fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily"
84148|NCT02061280|P1|Participant Flow|MICT Trial Design|"Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.~Randomized to one of 3 study treatments:~fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily"
84149|NCT02061280|O2|Outcome|LASST Trial Design|"Participants randomized to LASST will complete study procedures in the traditional format in which all study visits are conducted at the study site, all questionnaires are completed by pen/paper, and all spirometry is performed at the clinic site.~Randomized to one of 3 study treatments:~fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily."
84150|NCT02061280|O1|Outcome|MICT Trial Design|"Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.~Randomized to one of 3 study treatments:~fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily"
84151|NCT02061280|O2|Outcome|LASST Trial Design|"Participants randomized to LASST will complete study procedures in the traditional format in which all study visits are conducted at the study site, all questionnaires are completed by pen/paper, and all spirometry is performed at the clinic site.~Randomized to one of 3 study treatments:~fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily."
84208|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84152|NCT02061280|O1|Outcome|MICT Trial Design|"Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.~Randomized to one of 3 study treatments:~fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily"
84153|NCT02061280|O2|Outcome|LASST Trial Design|"Participants randomized to LASST will complete study procedures in the traditional format in which all study visits are conducted at the study site, all questionnaires are completed by pen/paper, and all spirometry is performed at the clinic site.~Randomized to one of 3 study treatments:~fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily"
84154|NCT02061280|O1|Outcome|MICT Trial Design|"MICT Trial:~Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.~Randomized to one of 3 study treatments:~fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily"
84155|NCT02061280|O2|Outcome|LASST Trial Design|"Participants randomized to LASST will complete study procedures in the traditional format in which all study visits are conducted at the study site, all questionnaires are completed by pen/paper, and all spirometry is performed at the clinic site.~Randomized to one of 3 study treatments:~fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily"
84156|NCT02061280|O1|Outcome|MICT Trial Design|"Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.~Randomized to one of 3 study treatments:~fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily"
84157|NCT02061280|E2|Reported Event|LASST Trial Design|"Participants randomized to LASST will complete study procedures in the traditional format in which all study visits are conducted at the study site, all questionnaires are completed by pen/paper, and all spirometry is performed at the clinic site.~Randomized to one of 3 study treatments:~fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily"
84158|NCT02061280|E1|Reported Event|MICT Trial Design|"MICT Trial:~Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.~Randomized to one of 3 study treatments:~fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily"
84159|NCT02060890|B1|Baseline|Group A|"Patients will undergo collection of tumor at the time of tumor resection and after confirmation of tumor progression and will have blood samples drawn pre-surgery and during standard of care follow-up visits. Patients will then be provided with a specialized tumor board recommendations for personalized treatment options for up to 4 medications based on the specimen analysis results within 35 days of surgery. Patients may then elect to initiate recommended therapy within 42 days of surgery.~specialized tumor board recommendation: feasibility of a specialized tumor board to come up with treatment recommendations no later than 35 days from surgery."
84160|NCT02060890|P1|Participant Flow|Treatment Group|"Patients will undergo collection of tumor at the time of tumor resection and after confirmation of tumor progression and will have blood samples drawn pre-surgery and during standard of care follow-up visits. Patients will then be provided with a specialized tumor board recommendations for personalized treatment options for up to 4 medications based on the specimen analysis results within 35 days of surgery. Patients may then elect to initiate recommended therapy within 42 days of surgery.~specialized tumor board recommendation: feasibility of a specialized tumor board to come up with treatment recommendations no later than 35 days from surgery."
84161|NCT02060890|O1|Outcome|Treatment Group|
84162|NCT02060890|O1|Outcome|Treatment Group|
84163|NCT02060890|O1|Outcome|Treatment Group|
84164|NCT02060890|O1|Outcome|Group A|
84165|NCT02060890|E1|Reported Event|Group A|Patients pursuing treatment after tumor board's genomics-informed treatment recommendation.
84166|NCT02060838|B3|Baseline|Total|Total of all reporting groups
84167|NCT02060838|B2|Baseline|ANH Blood Collected in a Syringe|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in a syringe, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
84168|NCT02060838|B1|Baseline|ANH Blood Collected in a Bag|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in an IV infusion bag, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
84169|NCT02060838|P2|Participant Flow|ANH Collected & Stored in a Syringe|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
84170|NCT02060838|P1|Participant Flow|ANH Collected & Stored in a Bag|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
87187|NCT02040779|P1|Participant Flow|Placebo BAI|Placebo breath-actuated inhaler (BAI) twice daily.
84171|NCT02060838|O2|Outcome|ANH Blood Collected in a Syringe|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in a syringe, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
84172|NCT02060838|O1|Outcome|ANH Blood Collected in a Bag|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in an IV infusion bag, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
84173|NCT02060838|O2|Outcome|ANH Blood Collected in a Syringe|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in a syringe, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
84174|NCT02060838|O1|Outcome|ANH Blood Collected in a Bag|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in an IV infusion bag, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
84175|NCT02060838|E2|Reported Event|ANH Blood Collected & Stored in a Syringe|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in a syringe, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
84176|NCT02060838|E1|Reported Event|ANH Blood Collected & Stored in a Bag|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in an IV infusion bag, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
84177|NCT02060539|B1|Baseline|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84178|NCT02060539|P1|Participant Flow|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84179|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84180|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84181|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84182|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84183|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84184|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84185|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84186|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84187|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84188|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84189|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84190|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84191|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84192|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84193|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84194|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84195|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84196|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84197|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84198|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84199|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84200|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84201|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84202|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84203|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84204|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84205|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84206|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84207|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84209|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84210|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84211|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84212|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84213|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84214|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84215|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84216|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84217|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84218|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84219|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84220|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84221|NCT02060539|E1|Reported Event|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
84222|NCT02060526|B4|Baseline|Total|Total of all reporting groups
84223|NCT02060526|B3|Baseline|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
84224|NCT02060526|B2|Baseline|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
84225|NCT02060526|B1|Baseline|No HGT-1410|Participants received no treatment (HGT-1410).
84226|NCT02060526|P3|Participant Flow|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally once every four weeks (Q4W) using surgically implanted IDDD or LP for 48 weeks.
84227|NCT02060526|P2|Participant Flow|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 milligram (mg) intrathecally once every two weeks (Q2W) using surgically implanted intrathecal drug delivery device (IDDD) or lumbar puncture (LP) for 48 weeks.
84228|NCT02060526|P1|Participant Flow|No HGT-1410|Participants received no treatment (HGT-1410).
84229|NCT02060526|O2|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
84230|NCT02060526|O1|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
84231|NCT02060526|O2|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
84232|NCT02060526|O1|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
84233|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
84234|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
84235|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
84236|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
84237|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
84238|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
84239|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
84240|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
84241|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
84242|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
84243|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
84244|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
84245|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
84246|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
84247|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
84248|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
84249|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
84250|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
84251|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
84252|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
84253|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
84254|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
84255|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
84256|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
84257|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
84258|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
84259|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
84260|NCT02060526|E3|Reported Event|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
84261|NCT02060526|E2|Reported Event|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
84262|NCT02060526|E1|Reported Event|No HGT-1410|Participants received no treatment (HGT-1410).
84263|NCT02060461|B1|Baseline|Comparison of Femtosecond Lasers in LASIK|Outcomes of femtosecond-assisted LASIK will be compared between yes in subjects using the FS200 laser in one eye and the IntraLase in the other.
84264|NCT02060461|P1|Participant Flow|Comparison of Femtosecond Lasers in LASIK|Outcomes of femtosecond-assisted LASIK will be compared between yes in subjects using the FS200 femtosecond laser in one eye and the IntraLase in the other.
84265|NCT02060461|O2|Outcome|IntraLase Femtosecond Laser LASIK|IntraLase femtosecond laser used to create LASIK flap
84266|NCT02060461|O1|Outcome|FS200 Femtosecond Laser LASIK|FS200 laser used to create LASIK flap
84267|NCT02060461|E2|Reported Event|IntraLase Femotsecond Laser LASIK|IntraLase femtosecond laser used to create LASIK flap
84268|NCT02060461|E1|Reported Event|FS200 Femtosecond Laser LASIK|FS200 femtosecond laser used to create LASIK flap
84269|NCT02060058|B4|Baseline|Total|Total of all reporting groups
84270|NCT02060058|B3|Baseline|Null Responder or Cirrhotic Patients|For null responder or cirrhotic patients, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 to 48.
84271|NCT02060058|B2|Baseline|Patients With 48 Weeks Therapy|For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is detectable at week 8 and undetectable at week 24, boceprevir+ PEG-IFN/RBV triple therapy will be administered from week 5 to week 32, followed by additional 12 weeks of PEG-IFN/RBV therapy.
84272|NCT02060058|B1|Baseline|Patients With 32 Week Therapy|For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is undetectable during 8-24 weeks, boceprevir+PEG-IFN/RBV triple therapy will be administered from week 5 to week 32.
84273|NCT02060058|P3|Participant Flow|Null Responder or Cirrhotic Patients|For null responder or cirrhotic patients, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 to 48.
84274|NCT02060058|P2|Participant Flow|Patients With 48 Weeks Therapy|For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is detectable at week 8 and undetectable at week 24, boceprevir+ PEG-IFN/RBV triple therapy will be administered from week 5 to week 32, followed by additional 12 weeks of PEG-IFN/RBV therapy.
84275|NCT02060058|P1|Participant Flow|Patients With 32 Week Therapy|For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is undetectable during 8-24 weeks, boceprevir+PEG-IFN/RBV triple therapy will be administered from week 5 to week 32.
84276|NCT02060058|O3|Outcome|Null Responder or Cirrhotic Patients|For null responder or cirrhotic patients, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 to 48.
84277|NCT02060058|O2|Outcome|Patients With 48 Weeks Therapy|For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is detectable at week 8 and undetectable at week 24, boceprevir+ PEG-IFN/RBV triple therapy will be administered from week 5 to week 32, followed by additional 12 weeks of PEG-IFN/RBV therapy.
84278|NCT02060058|O1|Outcome|Patients With 32 Week Therapy|For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is undetectable during 8-24 weeks, boceprevir+PEG-IFN/RBV triple therapy will be administered from week 5 to week 32.
84279|NCT02060058|O3|Outcome|Null Responder or Cirrhotic Patients|For null responder or cirrhotic patients, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 to 48.
84280|NCT02060058|O2|Outcome|Patients With 48 Weeks Therapy|For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is detectable at week 8 and undetectable at week 24, boceprevir+ PEG-IFN/RBV triple therapy will be administered from week 5 to week 32, followed by additional 12 weeks of PEG-IFN/RBV therapy.
84281|NCT02060058|O1|Outcome|Patients With 32 Week Therapy|For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is undetectable during 8-24 weeks, boceprevir+PEG-IFN/RBV triple therapy will be administered from week 5 to week 32.
84282|NCT02060058|O3|Outcome|Null Responder or Cirrhotic Patients|"For null responder or cirrhotic patients, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 to 48.~Stop trial intervention for boceprevir, PEG-IFN and RBV: Stop trial intervention for patients with 32 week therapy (arm A): for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped.~Stop trial intervention for patients with 48 weeks therapy (arm B): for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped.~Stop trial intervention for for null responder or cirrhotic patients: (arm C) for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped."
87468|NCT02039414|O1|Outcome|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
84283|NCT02060058|O2|Outcome|Patients With 48 Weeks Therapy|For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is detectable at week 8 and undetectable at week 24, boceprevir+ PEG-IFN/RBV triple therapy will be administered from week 5 to week 32, followed by additional 12 weeks of PEG-IFN/RBV therapy.
84284|NCT02060058|O1|Outcome|Patients With 32 Week Therapy|For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is undetectable during 8-24 weeks, boceprevir+PEG-IFN/RBV triple therapy will be administered from week 5 to week 32.
84285|NCT02060058|E3|Reported Event|Null Responder or Cirrhotic Patients|For null responder or cirrhotic patients, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 to 48.
84286|NCT02060058|E2|Reported Event|Patients With 48 Weeks Therapy|For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is detectable at week 8 and undetectable at week 24, boceprevir+ PEG-IFN/RBV triple therapy will be administered from week 5 to week 32, followed by additional 12 weeks of PEG-IFN/RBV therapy.
84287|NCT02060058|E1|Reported Event|Patients With 32 Week Therapy|For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is undetectable during 8-24 weeks, boceprevir+PEG-IFN/RBV triple therapy will be administered from week 5 to week 32.
84288|NCT02059993|B3|Baseline|Total|Total of all reporting groups
84289|NCT02059993|B2|Baseline|Control|The control group received the standardized antihypertensive medications but without receiving CPAP machine.
84290|NCT02059993|B1|Baseline|Continuous Positive Airway Pressure(CPAP) Group|The CPAP group received fixed-level CPAP titration using an automated pressure setting device for one night. The optimal CPAP pressure for each patient in the CPAP group was set at the minimum pressure required to abolish snoring, obstructive respiratory events, and airflow limitation for 95% of the night.
84291|NCT02059993|P2|Participant Flow|Control|The controls only received the cardiovascular drugs based on the guidelines but without continuous positive airway pressure machine.
84292|NCT02059993|P1|Participant Flow|Continuous Positive Airway Pressure(CPAP) Group|The continuous positive airway pressure group received fixed-level continuous positive airway pressure titration using an automated pressure and the the cardiovascular drugs based on the guidelines.
84293|NCT02059993|O2|Outcome|Control|The patients who use standardized drugs without CPAP machine.
84294|NCT02059993|O1|Outcome|Continuous Positive Airway Pressure(CPAP) Group|The subjects who received CPAP treatment and standardized medicine.
84295|NCT02059993|E2|Reported Event|Control|The control subjects received standardised anti-hypertension medications according to the current guildline.
84296|NCT02059993|E1|Reported Event|Continuous Positive Airway Pressure(CPAP) Group|The CPAP group received fixed-level CPAP titration using an automated pressure setting device for 1 night. The optimal CPAP pressure for each patient in the CPAP group was set at the minimum pressure required to abolish snoring, obstructive respiratory events, and airflow limitation for 95% of the night.
84297|NCT02059928|B1|Baseline|Intraosseous Device Placement|"Intraosseous device~Intraosseous Pressure Monitoring in Surgical Intensive Care Unit Patients"
84298|NCT02059928|P1|Participant Flow|Intraosseous Device Placement|"Intraosseous device~Intraosseous Device pressure measurement"
84299|NCT02059928|O1|Outcome|Intraosseous Device Placement|Intraosseous Pressure Monitoring in Surgical Intensive Care Unit Patients
84300|NCT02059928|E1|Reported Event|Intraosseous Device Placement|Intraosseous Pressure Monitoring in Surgical Intensive Care Unit Patients
84301|NCT02059902|B3|Baseline|Total|Total of all reporting groups
84302|NCT02059902|B2|Baseline|Lidocaine|"Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour)~Lidocaine: Lidocaine infusion runs for a total of 24 hours"
84303|NCT02059902|B1|Baseline|Normal Pain Management|"Normal saline (bolus followed by continuous infusion)~Placebo: Normal saline runs for a total of 24 hours"
84304|NCT02059902|P2|Participant Flow|Lidocaine|"Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour)~Lidocaine: Lidocaine infusion runs for a total of 24 hours"
84305|NCT02059902|P1|Participant Flow|Normal Pain Management|"Normal saline (bolus followed by continuous infusion)~Placebo: Normal saline runs for a total of 24 hours"
84306|NCT02059902|O2|Outcome|Lidocaine|"Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour)~Lidocaine: Lidocaine infusion runs for a total of 24 hours"
84307|NCT02059902|O1|Outcome|Normal Pain Management|"Normal saline (bolus followed by continuous infusion)~Placebo: Normal saline runs for a total of 24 hours"
84308|NCT02059902|E2|Reported Event|Lidocaine|"Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour)~Lidocaine: Lidocaine infusion runs for a total of 24 hours"
84309|NCT02059902|E1|Reported Event|Normal Pain Management|"Normal saline (bolus followed by continuous infusion)~Placebo: Normal saline runs for a total of 24 hours"
84310|NCT02059642|B3|Baseline|Total|Total of all reporting groups
84311|NCT02059642|B2|Baseline|MG01CI (1400 mg)|"MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily~MG01CI (1400 mg): MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily"
84312|NCT02059642|B1|Baseline|Placebo|"Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily~placebo: Placebo 1400 mg administered orally once daily"
84313|NCT02059642|P2|Participant Flow|MG01CI (1400 mg)|"MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily~MG01CI (1400 mg): MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily"
85215|NCT02055365|O1|Outcome|Day 1|Significantly Differentially expressed genes at Day 1 versus pre-vaccination baseline (FDR<0.05).
84314|NCT02059642|P1|Participant Flow|Placebo|"Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily~placebo: Placebo 1400 mg administered orally once daily"
84315|NCT02059642|O2|Outcome|MG01CI (1400 mg)|"MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily~MG01CI (1400 mg): MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily"
84316|NCT02059642|O1|Outcome|Placebo|"Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily~placebo: Placebo 1400 mg administered orally once daily"
84317|NCT02059642|O2|Outcome|MG01CI (1400 mg)|"MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily~MG01CI (1400 mg): MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily"
84318|NCT02059642|O1|Outcome|Placebo|"Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily~placebo: Placebo 1400 mg administered orally once daily"
84319|NCT02059642|E2|Reported Event|MG01CI (1400 mg)|"MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily~MG01CI (1400 mg): MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily"
84320|NCT02059642|E1|Reported Event|Placebo|"Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily~placebo: Placebo 1400 mg administered orally once daily"
84321|NCT02059395|B3|Baseline|Total|Total of all reporting groups
84322|NCT02059395|B2|Baseline|Mastery Based|"Participants do follow the content of the Canadian Heart and Stroke Foundation Heartsaver Course content based on their own pace (timeframe)~Mastery based learning: Participants are allowed to follow the course content at their own speed"
84323|NCT02059395|B1|Baseline|Time Based|"Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course~Time based learning: Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course according to the official course layout"
84324|NCT02059395|P2|Participant Flow|Mastery Based|"Participants do follow the content of the Canadian Heart and Stroke Foundation Heartsaver Course content based on their own pace (timeframe)~Mastery based learning: Participants are allowed to follow the course content at their own speed"
84325|NCT02059395|P1|Participant Flow|Time Based|"Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course~Time based learning: Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course according to the official course layout"
84326|NCT02059395|O2|Outcome|Mastery Based|"Participants do follow the content of the Canadian Heart and Stroke Foundation Heartsaver Course content based on their own pace (timeframe)~Mastery based learning: Participants are allowed to follow the course content at their own speed"
84327|NCT02059395|O1|Outcome|Time Based|"Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course~Time based learning: Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course according to the official course layout"
84328|NCT02059395|E2|Reported Event|Mastery Based|"Participants do follow the content of the Canadian Heart and Stroke Foundation Heartsaver Course content based on their own pace (timeframe)~Mastery based learning: Participants are allowed to follow the course content at their own speed"
84329|NCT02059395|E1|Reported Event|Time Based|"Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course~Time based learning: Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course according to the official course layout"
84330|NCT02059291|B10|Baseline|Total|Total of all reporting groups
84331|NCT02059291|B9|Baseline|Epoch 2 (Epoch 3) - Non-randomized Open Label TRAPS|Open-label treatment in Epoch 3 was initiated for TRAPS patients who rolled over from CACZ885D2203 or CACZ885D2207M.
84332|NCT02059291|B8|Baseline|Epoch 2: Non-randomized Open Label HIDS/MKD|"Participants in the 28 days to less than 2 years old cohort who received open-label canakinumab 150 mg (or 2mg/kg for patients weighing~≤ 40 kg) q4w."
84333|NCT02059291|B7|Baseline|Epoch 2: Non-randomized Open Label Treatment - crFMF|"Canakinumab-naïve Japanese patients with non-exon 10 mutations received open-label canakinumab 150 mg (or 2 mg/kg for patients weighing~≤ 40 kg) q4w"
84334|NCT02059291|B6|Baseline|Epoch 2: TRAPS: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
84335|NCT02059291|B5|Baseline|Epoch 2: TRAPS: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration
84336|NCT02059291|B4|Baseline|Epoch 2: HIDS/MKD: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
84337|NCT02059291|B3|Baseline|Epoch 2: HIDS/MKD: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
84338|NCT02059291|B2|Baseline|Epoch 2: crCMF: Placebo|"During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab.~150mg, participants were uptitrated to open-label canakinumab 300 mg"
84339|NCT02059291|B1|Baseline|Epoch 2: crFMF: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
84340|NCT02059291|P25|Participant Flow|Epoch 4: TRAPS - Open Label Cumulative Dose >=5400 mg|During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was > 5400 mg.
84341|NCT02059291|P24|Participant Flow|Epoch 4: TRAPS - Open Label Cumulative Dose 2700 - <5400 mg|During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was >= 2700 mg and < 5400 mg.
84342|NCT02059291|P23|Participant Flow|Epoch 4: TRAPS - Open Label Cumulative Dose < 2700 mg|During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was less than 2700 mg.
84343|NCT02059291|P22|Participant Flow|Epoch 4: HIDS/MKD - Open Label Cumulative Dose >=5400 mg|During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was > 5400 mg.
84344|NCT02059291|P21|Participant Flow|Epoch 4: HIDS/MKD - OL Cumulative Dose 2700 - <=5400 mg|During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was >= 2700 mg and < 5400 mg.
84345|NCT02059291|P20|Participant Flow|Epoch 4: HIDS/MKD - Open Label Cumulative Dose <2700 mg|During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was less than 2700 mg.
84346|NCT02059291|P19|Participant Flow|Epoch 4: crFMF - Open Label Cumulative Dose >=5400 mg|During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was > 5400 mg.
84347|NCT02059291|P18|Participant Flow|Epoch 4: crFMF - Open Label Cumulative Dose 2700 mg - <5400 mg|During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was >= 2700 mg and < 5400 mg.
84348|NCT02059291|P17|Participant Flow|Epoch 4: crFMF - Open Label Cumulative Dose <2700 mg|During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was less than 2700 mg.
84349|NCT02059291|P16|Participant Flow|Epoch 3: crFMF, HIDS/MKD, TRAPS - Not Re-randomized|All Epoch 2 non-responders were switched to canakinumab q8w at the start of Epoch 3 for 24 weeks,
84350|NCT02059291|P15|Participant Flow|Epoch 3: TRAPS Re-randomized From Epoch 2 - Placebo|Canakinumab responders who were initially randomized to canakinumab 150 mg q4w and did not re-flare in Epoch 2 were re-randomized at the start of Epoch 3 to placebo for 24 weeks.
84351|NCT02059291|P14|Participant Flow|Epoch 3: TRAPS Re-randomized From Epoch 2 - 150 mg|Canakinumab responders who were initially randomized to canakinumab 150 mg q4w and did not re-flare in Epoch 2 were re-randomized at the start of Epoch 3 to canakinumab 150 mg q8w for 24 weeks.
84352|NCT02059291|P13|Participant Flow|Epoch 3: HIDS/MKD Re-randomized From Epoch 2 - Placebo|Canakinumab responders who were initially randomized to canakinumab 150 mg q4w and did not re-flare in Epoch 2 were re-randomized at the start of Epoch 3 to placebo for 24 weeks.
84353|NCT02059291|P12|Participant Flow|Epoch 3: HIDs/MKD Re-randomized From Epoch 2 - 150 mg|Canakinumab responders who were initially randomized to canakinumab 150 mg q4w and did not re-flare in Epoch 2 were re-randomized at the start of Epoch 3 to canakinumab 150 mg q8w for 24 weeks.
84354|NCT02059291|P11|Participant Flow|Epoch 3: crFMF Re-randomized From Epoch 2 - Placebo|Canakinumab responders who were initially randomized to canakinumab 150 mg q4w and did not re-flare in Epoch 2 were re-randomized at the start of Epoch 3 to placebo for 24 weeks.
84355|NCT02059291|P10|Participant Flow|Epoch 3: crFMF Re-randomized From Epoch 2 - 150 mg|Canakinumab responders who were initially randomized to canakinumab 150 mg q4w and did not re-flare in Epoch 2 were re-randomized at the start of Epoch 3 to canakinumab 150 mg q8w for 24 weeks.
84356|NCT02059291|P9|Participant Flow|Epoch 2 (Epoch 3) - Non-randomized Open Label TRAPS|Open-label treatment in Epoch 3 was initiated for TRAPS patients who rolled over from CACZ885D2203 or CACZ885D2207M.
84357|NCT02059291|P8|Participant Flow|Epoch 2: Non-randomized Open Label HIDS/MKD|"Participants in the 28 days to less than 2 years old cohort who received open-label canakinumab 150 mg (or 2mg/kg for patients weighing~≤ 40 kg) q4w."
84358|NCT02059291|P7|Participant Flow|Epoch 2: Non-randomized Open Label Treatment - crFMF|"Canakinumab-naïve Japanese patients with non-exon 10 mutations received open-label canakinumab 150 mg (or 2 mg/kg for patients weighing~≤ 40 kg) q4w ."
84359|NCT02059291|P6|Participant Flow|Epoch 2: TRAPS: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
84360|NCT02059291|P5|Participant Flow|Epoch 2: TRAPS: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration
88417|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
84361|NCT02059291|P4|Participant Flow|Epoch 2: HIDS/MKD: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
84362|NCT02059291|P3|Participant Flow|Epoch 2: HIDS/MKD: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
84363|NCT02059291|P2|Participant Flow|Epoch 2: crCMF: Placebo|"During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab.~150mg, participants were uptitrated to open-label canakinumab 300 mg"
84364|NCT02059291|P1|Participant Flow|Epoch 2: crFMF: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
84365|NCT02059291|O6|Outcome|Epoch 2: TRAPS: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
84366|NCT02059291|O5|Outcome|Epoch 2: TRAPS: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration
84367|NCT02059291|O4|Outcome|Epoch 2: HIDS/MKD: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
84368|NCT02059291|O3|Outcome|Epoch 2: HIDS/MKD: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
84369|NCT02059291|O2|Outcome|Epoch 2: crCMF: Placebo|"During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab.~150mg, participants were uptitrated to open-label canakinumab 300 mg"
84370|NCT02059291|O1|Outcome|Epoch 2: crFMF: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
84371|NCT02059291|O6|Outcome|Epoch 2: TRAPS: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
84372|NCT02059291|O5|Outcome|Epoch 2: TRAPS: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration
84373|NCT02059291|O4|Outcome|Epoch 2: HIDS/MKD: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
84374|NCT02059291|O3|Outcome|Epoch 2: HIDS/MKD: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
84375|NCT02059291|O2|Outcome|Epoch 2: crCMF: Placebo|"During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab.~150mg, participants were uptitrated to open-label canakinumab 300 mg"
84376|NCT02059291|O1|Outcome|Epoch 2: crFMF: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
84377|NCT02059291|O6|Outcome|Epoch 2: TRAPS: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
84378|NCT02059291|O5|Outcome|Epoch 2: TRAPS: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration
84379|NCT02059291|O4|Outcome|Epoch 2: HIDS/MKD: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
84380|NCT02059291|O3|Outcome|Epoch 2: HIDS/MKD: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
84381|NCT02059291|O2|Outcome|Epoch 2: crCMF: Placebo|"During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab.~150mg, participants were uptitrated to open-label canakinumab 300 mg"
84382|NCT02059291|O1|Outcome|Epoch 2: crFMF: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
84383|NCT02059291|O6|Outcome|Epoch 2: TRAPS: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
84384|NCT02059291|O5|Outcome|Epoch 2: TRAPS: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration
84385|NCT02059291|O4|Outcome|Epoch 2: HIDS/MKD: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
84408|NCT02059291|E7|Reported Event|Randomized ACZ and Placebo HIDS/MKD Pts - No Medication Events|Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
84409|NCT02059291|E6|Reported Event|Randomized ACZ and Placebo HIDS/MKD Pts - Placebo Events|Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
84410|NCT02059291|E5|Reported Event|Randomized ACZ and Placebo TRAPS Patients - ACZ Events|Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
84386|NCT02059291|O3|Outcome|Epoch 2: HIDS/MKD: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
84387|NCT02059291|O2|Outcome|Epoch 2: crCMF: Placebo|"During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab.~150mg, participants were uptitrated to open-label canakinumab 300 mg"
84388|NCT02059291|O1|Outcome|Epoch 2: crFMF: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
84389|NCT02059291|O6|Outcome|Epoch 2: TRAPS: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
84390|NCT02059291|O5|Outcome|Epoch 2: TRAPS: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration
84391|NCT02059291|O4|Outcome|Epoch 2: HIDS/MKD: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
84392|NCT02059291|O3|Outcome|Epoch 2: HIDS/MKD: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
84393|NCT02059291|O2|Outcome|Epoch 2: crCMF: Placebo|"During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab.~150mg, participants were uptitrated to open-label canakinumab 300 mg"
84394|NCT02059291|O1|Outcome|Epoch 2: crFMF: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
84395|NCT02059291|E20|Reported Event|Any ACZ crFMF Patients - ACZ Events|Patients who received ACZ885 during epoch 2 and/or epoch 3
84396|NCT02059291|E19|Reported Event|Any ACZ crFMF Patients - No Medication Events|Patients who received ACZ885 during epoch 2 and/or epoch 3
84397|NCT02059291|E18|Reported Event|Any ACZ crFMF Patients - Placebo Events|Patients who received ACZ885 during epoch 2 and/or epoch 3
84398|NCT02059291|E17|Reported Event|Any ACZ HIDS/MKD Patients - ACZ Events|Patients who received ACZ885 during epoch 2 and/or epoch 3
84399|NCT02059291|E16|Reported Event|Any ACZ HIDS/MKD Patients - No Medication Events|Patients who received ACZ885 during epoch 2 and/or epoch 3
84400|NCT02059291|E15|Reported Event|Any ACZ HIDS/MKD Patients - Placebo Events|Patients who received ACZ885 during epoch 2 and/or epoch 3
84401|NCT02059291|E14|Reported Event|Any ACZ TRAPS Patients - ACZ Events|Patients who received ACZ885 during epoch 2 and/or epoch 3
84402|NCT02059291|E13|Reported Event|Any ACZ TRAPS Patients - no Medication Events|Patients who received ACZ885 during epoch 2 and/or epoch 3
84403|NCT02059291|E12|Reported Event|Any ACZ TRAPS Patients - Placebo Events|Patients who received ACZ885 during epoch 2 and/or epoch 3
84404|NCT02059291|E11|Reported Event|Randomized ACZ and Placebo crFMF Patients - ACZ Events|Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
84405|NCT02059291|E10|Reported Event|Randomized ACZ and Placebo crFMF Pts - No Medication Events|Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
84406|NCT02059291|E9|Reported Event|Randomized ACZ and Placebo crFMF Patients - Placebo Events|Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
84407|NCT02059291|E8|Reported Event|Randomized ACZ and Placebo HIDS/MKD Patients - ACZ Events|Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
85216|NCT02055365|O4|Outcome|Week 2|Differentially expressed genes at Week 2 versus pre-vaccination baseline (p<0.05).
84411|NCT02059291|E4|Reported Event|Randomized ACZ and Placebo TRAPS Pts - No Medication Events|Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3 .
84412|NCT02059291|E3|Reported Event|Randomized ACZ and Placebo TRAPS Patients – Placebo Events|Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3.
84413|NCT02059291|E2|Reported Event|Non-randomized Open Label TRAPS Patients|Open-label treatment in Epoch 3 was initiated for TRAPS patients who rolled over from CACZ885D2203 or CACZ885D2207M
84414|NCT02059291|E1|Reported Event|Non-randomized Open Label crFMF, HIDS/MKD Patients|"Canakinumab-naïve Japanese patients with non-exon 10 mutations with cr-FMF who received open-label canakinumab 150 mg (or 2 mg/kg for patients weighing ≤ 40 kg) q4w; and patients in the 28 days to less than 2 years old cohort with HIDS/MKD who received open-label canakinumab 150 mg (or 2mg/kg for patients weighing~≤ 40 kg) q4w"
84415|NCT02059187|B3|Baseline|Total|Total of all reporting groups
84416|NCT02059187|B2|Baseline|Lantus™|Lantus™ administered subcutaneously once daily.
84417|NCT02059187|B1|Baseline|MK-1293|MK-1293 administered subcutaneously once daily.
84418|NCT02059187|P2|Participant Flow|Lantus™|Lantus™ administered subcutaneously once daily.
84419|NCT02059187|P1|Participant Flow|MK-1293|MK-1293 administered subcutaneously once daily.
84420|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
84421|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
84422|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
84423|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
84424|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
84425|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
84426|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
84427|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
84428|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
84429|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
84430|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
84431|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
84432|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
84433|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
84434|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
84435|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
84436|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
84437|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
84438|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
84439|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
84440|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
84441|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
84442|NCT02059187|E2|Reported Event|Lantus™|Lantus™ administered subcutaneously once daily.
84443|NCT02059187|E1|Reported Event|MK-1293|MK-1293 administered subcutaneously once daily.
84444|NCT02059174|B1|Baseline|All Participants|MK-1293 or EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
84445|NCT02059174|P2|Participant Flow|EU-Lantus™ / MK-1293 / EU-Lantus™ / MK-1293|MK-1293 or EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
84446|NCT02059174|P1|Participant Flow|MK-1293 / EU-Lantus™ / MK-1293 / EU-Lantus™|MK-1293 or EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
84447|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
84448|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
84449|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
84450|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
84451|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
84452|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
84453|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
84454|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
84455|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
84456|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
84457|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
84458|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
84459|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
84460|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
84461|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
84462|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
84463|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
84464|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
84465|NCT02059174|E2|Reported Event|EU-Lantus™ 0.4 Units.kg SC|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between treatment periods
84466|NCT02059174|E1|Reported Event|MK-1293 0.4 Units/kg SC|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between treatment periods
84467|NCT02059161|B3|Baseline|Total|Total of all reporting groups
84468|NCT02059161|B2|Baseline|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84469|NCT02059161|B1|Baseline|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84470|NCT02059161|P2|Participant Flow|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84471|NCT02059161|P1|Participant Flow|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84472|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84473|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84474|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84475|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84476|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84477|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84478|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84479|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84480|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84481|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84482|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84483|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84484|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84485|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84565|NCT02058992|O1|Outcome|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
84486|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84487|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84488|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84489|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84490|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84491|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84492|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84493|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84494|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84495|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84496|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84497|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84498|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84499|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84500|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84501|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84502|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84503|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84504|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84505|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84506|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84507|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84508|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84509|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84510|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84511|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
88418|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
84512|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84513|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84514|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84515|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84516|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84517|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84518|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84519|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84520|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84521|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84522|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84523|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84524|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84525|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84526|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84527|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84528|NCT02059161|E2|Reported Event|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84529|NCT02059161|E1|Reported Event|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
84530|NCT02059135|B3|Baseline|Total|Total of all reporting groups
84531|NCT02059135|B2|Baseline|Normal Saline 0.9%|"Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.~Normal Saline 0.9%: Placebo Comparator: Normal Saline 0.9%"
84532|NCT02059135|B1|Baseline|Recombinant Human Antithrombin (ATryn)|"ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days~Recombinant human antithrombin (ATryn): Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days"
84533|NCT02059135|P2|Participant Flow|Normal Saline 0.9%|"Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.~Normal Saline 0.9%: Placebo Comparator: Normal Saline 0.9%"
84534|NCT02059135|P1|Participant Flow|Recombinant Human Antithrombin (ATryn)|"ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days~Recombinant human antithrombin (ATryn): Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days"
84535|NCT02059135|O2|Outcome|Normal Saline 0.9%|"Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.~Normal Saline 0.9%: Placebo Comparator: Normal Saline 0.9%"
84536|NCT02059135|O1|Outcome|Recombinant Human Antithrombin (ATryn)|"ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days~Recombinant human antithrombin (ATryn): Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days"
84537|NCT02059135|O2|Outcome|Normal Saline 0.9%|"Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.~Normal Saline 0.9%: Placebo Comparator: Normal Saline 0.9%"
84538|NCT02059135|O1|Outcome|Recombinant Human Antithrombin (ATryn)|"ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days~Recombinant human antithrombin (ATryn): Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days"
84539|NCT02059135|O2|Outcome|Normal Saline 0.9%|"Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.~Normal Saline 0.9%: Placebo Comparator: Normal Saline 0.9%"
84540|NCT02059135|O1|Outcome|Recombinant Human Antithrombin (ATryn)|"ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days~Recombinant human antithrombin (ATryn): Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days"
84541|NCT02059135|E4|Reported Event|Neonatal Safety Population: Placebo|Neonates born to mothers treated with placebo (Normal Saline 0.9%)
84542|NCT02059135|E3|Reported Event|Neonatal Safety Population: ATryn|Neonates born to mothers treated with Recombinant Human Antithrombin (ATryn)
84543|NCT02059135|E2|Reported Event|Maternal/Fetal Safety Population: Placebo (Normal Saline 0.9%)|Subjects treated with Placebo; Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.
84544|NCT02059135|E1|Reported Event|Maternal/Fetal Safety Population: ATryn|"Subjects treated with Recombinant human antithrombin (ATryn):~ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days"
84545|NCT02059070|B3|Baseline|Total|Total of all reporting groups
84546|NCT02059070|B2|Baseline|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
84547|NCT02059070|B1|Baseline|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
84548|NCT02059070|P2|Participant Flow|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
84549|NCT02059070|P1|Participant Flow|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
84550|NCT02059070|O2|Outcome|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
84551|NCT02059070|O1|Outcome|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
84552|NCT02059070|O2|Outcome|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
84553|NCT02059070|O1|Outcome|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
84554|NCT02059070|O2|Outcome|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
84555|NCT02059070|O1|Outcome|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
84556|NCT02059070|O2|Outcome|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
84557|NCT02059070|O1|Outcome|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
84558|NCT02059070|E2|Reported Event|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
84559|NCT02059070|E1|Reported Event|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
84560|NCT02058992|B1|Baseline|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
84561|NCT02058992|P1|Participant Flow|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
84562|NCT02058992|O1|Outcome|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
84563|NCT02058992|O1|Outcome|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
84564|NCT02058992|O1|Outcome|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
88419|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
84566|NCT02058992|O1|Outcome|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
84567|NCT02058992|O1|Outcome|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
84568|NCT02058992|E1|Reported Event|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
84569|NCT02058836|B3|Baseline|Total|Total of all reporting groups
84570|NCT02058836|B2|Baseline|Saline Injection|"The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment.~Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84571|NCT02058836|B1|Baseline|Botox Injection|"The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit.~Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84572|NCT02058836|P2|Participant Flow|Saline Injection|"The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment.~Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84573|NCT02058836|P1|Participant Flow|Botox Injection|"The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit.~Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84574|NCT02058836|O2|Outcome|Saline Injection|"The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment.~Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84575|NCT02058836|O1|Outcome|Botox Injection|"The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit.~Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84576|NCT02058836|O2|Outcome|Saline Injection|"The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment.~Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84577|NCT02058836|O1|Outcome|Botox Injection|"The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit.~Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84578|NCT02058836|O2|Outcome|Saline Injection|"The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment.~Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84579|NCT02058836|O1|Outcome|Botox Injection|"The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit.~Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84580|NCT02058836|O2|Outcome|Saline Injection|"The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment.~Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84581|NCT02058836|O1|Outcome|Botox Injection|"The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit.~Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84582|NCT02058836|O2|Outcome|Saline Injection|"The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment.~Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84583|NCT02058836|O1|Outcome|Botox Injection|"The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit.~Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84584|NCT02058836|O2|Outcome|Saline Injection|"The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment.~Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84585|NCT02058836|O1|Outcome|Botox Injection|"The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit.~Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84586|NCT02058836|O2|Outcome|Saline Injection|"The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment.~Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84587|NCT02058836|O1|Outcome|Botox Injection|"The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit.~Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84588|NCT02058836|O2|Outcome|Saline Injection|"The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment.~Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84589|NCT02058836|O1|Outcome|Botox Injection|"The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit.~Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84590|NCT02058836|O2|Outcome|Saline Injection|"The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment.~Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84591|NCT02058836|O1|Outcome|Botox Injection|"The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit.~Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84592|NCT02058836|O2|Outcome|Saline Injection|"The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment.~Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84593|NCT02058836|O1|Outcome|Botox Injection|"The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit.~Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84594|NCT02058836|O2|Outcome|Saline Injection|"The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment.~Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
88420|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
84595|NCT02058836|O1|Outcome|Botox Injection|"The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit.~Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84596|NCT02058836|O2|Outcome|Saline Injection|"The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment.~Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84597|NCT02058836|O1|Outcome|Botox Injection|"The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit.~Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84598|NCT02058836|E2|Reported Event|Saline Injection|"The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment.~Normal saline injection: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84599|NCT02058836|E1|Reported Event|Botox Injection|"The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit.~Botox Injection: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area."
84600|NCT02058628|B3|Baseline|Total|Total of all reporting groups
84601|NCT02058628|B2|Baseline|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
84602|NCT02058628|B1|Baseline|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
84603|NCT02058628|P2|Participant Flow|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization schedule.
84604|NCT02058628|P1|Participant Flow|DUAC®|Participants received DUAC® (1.2 percent clindamycin + 3 percent of benzoyl peroxide [BPO]) once daily in the evening for 12 weeks as per the randomization schedule.
84605|NCT02058628|O2|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
84606|NCT02058628|O1|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
84607|NCT02058628|O2|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
84608|NCT02058628|O1|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
84609|NCT02058628|O2|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
84610|NCT02058628|O1|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
84611|NCT02058628|O2|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization.
84612|NCT02058628|O1|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
84613|NCT02058628|O2|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
84614|NCT02058628|O1|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
84615|NCT02058628|O2|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
84616|NCT02058628|O1|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
84617|NCT02058628|O2|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
84618|NCT02058628|O1|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
84619|NCT02058628|O2|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization schedule
84620|NCT02058628|O1|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
84621|NCT02058628|O2|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
84622|NCT02058628|O1|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
84623|NCT02058628|O2|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization schedule
84624|NCT02058628|O1|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
84625|NCT02058628|O2|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
84626|NCT02058628|O1|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of benzoyl peroxide (BPO)) once daily in the evening for 12 weeks as per the randomization schedule
84627|NCT02058628|O2|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
84628|NCT02058628|O1|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
84629|NCT02058628|O2|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
84630|NCT02058628|O1|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
84631|NCT02058628|E2|Reported Event|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization schedule
84632|NCT02058628|E1|Reported Event|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of benzoyl peroxide (BPO)) once daily in the evening for 12 weeks as per the randomization schedule
84633|NCT02058563|B3|Baseline|Total|Total of all reporting groups
84634|NCT02058563|B2|Baseline|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
84635|NCT02058563|B1|Baseline|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
84636|NCT02058563|P2|Participant Flow|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II ) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
84637|NCT02058563|P1|Participant Flow|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
84638|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
84639|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
84640|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
84641|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
84642|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
84643|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
84644|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
84645|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
84646|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
84647|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
84648|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
84649|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
84650|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
84651|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
84652|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
84653|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
84654|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
84655|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
84656|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
84657|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
84658|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
84659|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
84660|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
84661|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
84662|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
84663|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
84664|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
84665|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
84666|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
84667|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
84668|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
84669|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
84670|NCT02058563|E2|Reported Event|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
84671|NCT02058563|E1|Reported Event|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
84672|NCT02058537|B1|Baseline|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.~Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
84673|NCT02058537|P1|Participant Flow|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.~Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
84674|NCT02058537|O1|Outcome|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.~Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
84675|NCT02058537|O1|Outcome|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.~Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
84676|NCT02058537|O1|Outcome|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.~Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
84677|NCT02058537|E1|Reported Event|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.~Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
84678|NCT02058498|B1|Baseline|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.~Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
84679|NCT02058498|P1|Participant Flow|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.~Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
84680|NCT02058498|O1|Outcome|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.~Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
84681|NCT02058498|O1|Outcome|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.~Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
84682|NCT02058498|O1|Outcome|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.~Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
84683|NCT02058498|E1|Reported Event|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.~Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
84684|NCT02058290|B3|Baseline|Total|Total of all reporting groups
84685|NCT02058290|B2|Baseline|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
84686|NCT02058290|B1|Baseline|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
84687|NCT02058290|P2|Participant Flow|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
84706|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84707|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84688|NCT02058290|P1|Participant Flow|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
84689|NCT02058290|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
84690|NCT02058290|O1|Outcome|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
84691|NCT02058290|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
84692|NCT02058290|O1|Outcome|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
84693|NCT02058290|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
84694|NCT02058290|O1|Outcome|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
84695|NCT02058290|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
84696|NCT02058290|O1|Outcome|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
84697|NCT02058290|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
84698|NCT02058290|O1|Outcome|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
84699|NCT02058290|E2|Reported Event|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
84700|NCT02058290|E1|Reported Event|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
84701|NCT02058160|B3|Baseline|Total|Total of all reporting groups
84702|NCT02058160|B2|Baseline|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84703|NCT02058160|B1|Baseline|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84704|NCT02058160|P2|Participant Flow|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84705|NCT02058160|P1|Participant Flow|Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)|FRC injected subcutaneously once daily (QD) for 30 weeks. Dose individually adjusted.
84708|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84709|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84710|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84711|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84712|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84713|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84714|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84715|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84716|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84717|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84718|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84719|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84720|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84721|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84722|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84723|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84724|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84725|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84726|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84727|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84728|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84729|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84730|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84731|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84732|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84733|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84734|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84735|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84736|NCT02058160|E2|Reported Event|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted (median exposure: 210 days).
84737|NCT02058160|E1|Reported Event|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted (median exposure: 211 days).
84738|NCT02058147|B4|Baseline|Total|Total of all reporting groups
84739|NCT02058147|B3|Baseline|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
84740|NCT02058147|B2|Baseline|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84741|NCT02058147|B1|Baseline|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84742|NCT02058147|P3|Participant Flow|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
84743|NCT02058147|P2|Participant Flow|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84744|NCT02058147|P1|Participant Flow|Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)|FRC injected subcutaneously once daily (QD) for 30 weeks. Dose individually adjusted.
84745|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
84746|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84747|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84748|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
84749|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84750|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84751|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
84752|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
85217|NCT02055365|O3|Outcome|Week 1|Differentially expressed genes at Week 1 versus pre-vaccination baseline (p<0.05).
84753|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84754|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
84755|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84756|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84757|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
84758|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84759|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84760|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
84761|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84762|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84763|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84764|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84765|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
84766|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84767|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84768|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
84769|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84770|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84771|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
84772|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84773|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84774|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
84775|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84776|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84777|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
84778|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84779|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84780|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
84781|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84782|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84783|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
84784|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84785|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84786|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
84787|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84788|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
84789|NCT02058147|E3|Reported Event|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose) median exposure: 211 days).
84790|NCT02058147|E2|Reported Event|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted (median exposure: 211 days).
84791|NCT02058147|E1|Reported Event|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted (median exposure: 211 days).
84792|NCT02058069|B1|Baseline|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
84793|NCT02058069|P1|Participant Flow|Robotic Assisted Total Knee Arthroplasty|"Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.~Participants throughout this posting is equivalent to the number of knees."
84794|NCT02058069|O1|Outcome|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
84795|NCT02058069|O1|Outcome|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
84796|NCT02058069|O1|Outcome|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
84797|NCT02058069|O1|Outcome|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
84798|NCT02058069|O1|Outcome|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
84799|NCT02058069|O1|Outcome|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
84800|NCT02058069|E1|Reported Event|Robotic Assisted Total Knee Arthroplasty|"Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.~Note regarding serious AEs:~Adhesions and arthrofibrosis are surgical complications that can result from knee surgery and present as stiffness and restriction of ROM. Reasons for stiffness and restriction of ROM after TKA are multifactorial and may be influenced by factors such as the patient’s overall health, motivation, and compliance to their rehabilitation regimen. The Principal Investigator and study Investigators stated these adverse events are not related to the use of the Investigational Device."
84801|NCT02057952|B4|Baseline|Total|Total of all reporting groups
84802|NCT02057952|B3|Baseline|Video Conference Weight Management|"Education and exercise delivered through video conference.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
84803|NCT02057952|B2|Baseline|In Person Weight Management|"Education and exercise in a community health center environment.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
84804|NCT02057952|B1|Baseline|Usual Care Control|No intervention.
84805|NCT02057952|P3|Participant Flow|Video Conference Weight Management|"Education and exercise delivered through video conference.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
84806|NCT02057952|P2|Participant Flow|In Person Weight Management|"Education and exercise in a community health center environment.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
84807|NCT02057952|P1|Participant Flow|Usual Care Control|No intervention.
84808|NCT02057952|O3|Outcome|Video Conference Weight Management|"Education and exercise delivered through video conference.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
84809|NCT02057952|O2|Outcome|In Person Weight Management|"Education and exercise in a community health center environment.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
84810|NCT02057952|O1|Outcome|Usual Care Control|No intervention.
84811|NCT02057952|O3|Outcome|Video Conference Weight Management|"Education and exercise delivered through video conference.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
84812|NCT02057952|O2|Outcome|In Person Weight Management|"Education and exercise in a community health center environment.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
84813|NCT02057952|O1|Outcome|Usual Care Control|No intervention.
84814|NCT02057952|O3|Outcome|Video Conference Weight Management|"Education and exercise delivered through video conference.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
84815|NCT02057952|O2|Outcome|In Person Weight Management|"Education and exercise in a community health center environment.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
84816|NCT02057952|O1|Outcome|Usual Care Control|No intervention.
84817|NCT02057952|O3|Outcome|Video Conference Weight Management|"Education and exercise delivered through video conference.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
84818|NCT02057952|O2|Outcome|In Person Weight Management|"Education and exercise in a community health center environment.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
84819|NCT02057952|O1|Outcome|Usual Care Control|No intervention.
84820|NCT02057952|O3|Outcome|Video Conference Weight Management|"Education and exercise delivered through video conference.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
84821|NCT02057952|O2|Outcome|In Person Weight Management|"Education and exercise in a community health center environment.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
84822|NCT02057952|O1|Outcome|Usual Care Control|No intervention.
84823|NCT02057952|O3|Outcome|Video Conference Weight Management|"Education and exercise delivered through video conference.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
84824|NCT02057952|O2|Outcome|In Person Weight Management|"Education and exercise in a community health center environment.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
84825|NCT02057952|O1|Outcome|Usual Care Control|No intervention.
84826|NCT02057952|O3|Outcome|Video Conference Weight Management|"Education and exercise delivered through video conference.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
84827|NCT02057952|O2|Outcome|In Person Weight Management|"Education and exercise in a community health center environment.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
84828|NCT02057952|O1|Outcome|Usual Care Control|No intervention.
84864|NCT02057835|O2|Outcome|BI 691751 10mg|Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
84829|NCT02057952|O3|Outcome|Video Conference Weight Management|"Education and exercise delivered through video conference.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
84830|NCT02057952|O2|Outcome|In Person Weight Management|"Education and exercise in a community health center environment.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
84831|NCT02057952|O1|Outcome|Usual Care Control|No intervention.
84832|NCT02057952|O3|Outcome|Video Conference Weight Management|"Education and exercise delivered through video conference.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
84833|NCT02057952|O2|Outcome|In Person Weight Management|"Education and exercise in a community health center environment.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
84834|NCT02057952|O1|Outcome|Usual Care Control|No intervention.
84835|NCT02057952|O3|Outcome|Video Conference Weight Management|"Education and exercise delivered through video conference.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
84836|NCT02057952|O2|Outcome|In Person Weight Management|"Education and exercise in a community health center environment.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
84837|NCT02057952|O1|Outcome|Usual Care Control|No intervention.
84838|NCT02057952|E3|Reported Event|Video Conference Weight Management|"Education and exercise delivered through video conference.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
84839|NCT02057952|E2|Reported Event|In Person Weight Management|"Education and exercise in a community health center environment.~Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance."
84840|NCT02057952|E1|Reported Event|Usual Care Control|No intervention.
84841|NCT02057835|B11|Baseline|Total|Total of all reporting groups
84842|NCT02057835|B10|Baseline|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
84843|NCT02057835|B9|Baseline|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
84844|NCT02057835|B8|Baseline|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
84845|NCT02057835|B7|Baseline|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
84846|NCT02057835|B6|Baseline|Japanese: Placebo|Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
84847|NCT02057835|B5|Baseline|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
84848|NCT02057835|B4|Baseline|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
84849|NCT02057835|B3|Baseline|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
84850|NCT02057835|B2|Baseline|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
84851|NCT02057835|B1|Baseline|Chinese: Placebo|Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
84852|NCT02057835|P10|Participant Flow|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
84853|NCT02057835|P9|Participant Flow|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
84854|NCT02057835|P8|Participant Flow|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
84855|NCT02057835|P7|Participant Flow|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
84856|NCT02057835|P6|Participant Flow|Japanese: Placebo|Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
84857|NCT02057835|P5|Participant Flow|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
84858|NCT02057835|P4|Participant Flow|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
84859|NCT02057835|P3|Participant Flow|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
84860|NCT02057835|P2|Participant Flow|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
84861|NCT02057835|P1|Participant Flow|Chinese: Placebo|Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
84862|NCT02057835|O4|Outcome|BI 691751 60mg|Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
84863|NCT02057835|O3|Outcome|BI 691751 30mg|Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
84865|NCT02057835|O1|Outcome|BI 691751 5mg|Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
84866|NCT02057835|O8|Outcome|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
84867|NCT02057835|O7|Outcome|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
84868|NCT02057835|O6|Outcome|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
84869|NCT02057835|O5|Outcome|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
84870|NCT02057835|O4|Outcome|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
84871|NCT02057835|O3|Outcome|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
84872|NCT02057835|O2|Outcome|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
84873|NCT02057835|O1|Outcome|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
84874|NCT02057835|O4|Outcome|BI 691751 60mg|Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
84875|NCT02057835|O3|Outcome|BI 691751 30mg|Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
84876|NCT02057835|O2|Outcome|BI 691751 10mg|Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
84877|NCT02057835|O1|Outcome|BI 691751 5mg|Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
84878|NCT02057835|O8|Outcome|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
84879|NCT02057835|O7|Outcome|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
84880|NCT02057835|O6|Outcome|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
84881|NCT02057835|O5|Outcome|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
84882|NCT02057835|O4|Outcome|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
84883|NCT02057835|O3|Outcome|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
84884|NCT02057835|O2|Outcome|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
84885|NCT02057835|O1|Outcome|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
84886|NCT02057835|O4|Outcome|BI 691751 60mg|Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
84887|NCT02057835|O3|Outcome|BI 691751 30mg|Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
84888|NCT02057835|O2|Outcome|BI 691751 10mg|Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
84889|NCT02057835|O1|Outcome|BI 691751 5mg|Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
84890|NCT02057835|O8|Outcome|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
84891|NCT02057835|O7|Outcome|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
84892|NCT02057835|O6|Outcome|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
84893|NCT02057835|O5|Outcome|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
84894|NCT02057835|O4|Outcome|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
84895|NCT02057835|O3|Outcome|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
84896|NCT02057835|O2|Outcome|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
84897|NCT02057835|O1|Outcome|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
84898|NCT02057835|O4|Outcome|BI 691751 60mg|Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
84899|NCT02057835|O3|Outcome|BI 691751 30mg|Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
84900|NCT02057835|O2|Outcome|BI 691751 10mg|Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
84901|NCT02057835|O1|Outcome|BI 691751 5mg|Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
84902|NCT02057835|O8|Outcome|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
84903|NCT02057835|O7|Outcome|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
84904|NCT02057835|O6|Outcome|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
84905|NCT02057835|O5|Outcome|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
84906|NCT02057835|O4|Outcome|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
84907|NCT02057835|O3|Outcome|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
84908|NCT02057835|O2|Outcome|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
84909|NCT02057835|O1|Outcome|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
84910|NCT02057835|O4|Outcome|BI 691751 60mg|Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
84911|NCT02057835|O3|Outcome|BI 691751 30mg|Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
84912|NCT02057835|O2|Outcome|BI 691751 10mg|Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
84913|NCT02057835|O1|Outcome|BI 691751 5mg|Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
84914|NCT02057835|O8|Outcome|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
84915|NCT02057835|O7|Outcome|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
84916|NCT02057835|O6|Outcome|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
84917|NCT02057835|O5|Outcome|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
84918|NCT02057835|O4|Outcome|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
84919|NCT02057835|O3|Outcome|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
84920|NCT02057835|O2|Outcome|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
84921|NCT02057835|O1|Outcome|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
84922|NCT02057835|O10|Outcome|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
84923|NCT02057835|O9|Outcome|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
84924|NCT02057835|O8|Outcome|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
84925|NCT02057835|O7|Outcome|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
84926|NCT02057835|O6|Outcome|Japanese: Placebo|Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
84927|NCT02057835|O5|Outcome|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
84928|NCT02057835|O4|Outcome|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
84929|NCT02057835|O3|Outcome|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
84930|NCT02057835|O2|Outcome|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
84931|NCT02057835|O1|Outcome|Chinese: Placebo|Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
84932|NCT02057835|E5|Reported Event|BI 691751 60mg|Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
84933|NCT02057835|E4|Reported Event|BI 691751 30mg|Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
84934|NCT02057835|E3|Reported Event|BI 691751 10mg|Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
84935|NCT02057835|E2|Reported Event|BI 691751 5mg|Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
84936|NCT02057835|E1|Reported Event|Placebo|Participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
84937|NCT02057692|B5|Baseline|Total|Total of all reporting groups
84938|NCT02057692|B4|Baseline|Placebo|Participants received placebo matched to maralixibat oral solution for 13 weeks (dose escalation and stable dosing period).
84939|NCT02057692|B3|Baseline|Maralixibat 280 mcg/kg/Day|Participants received high dose maralixibat 280 mcg/kg/day oral solution for 8 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35, 70, 140 and 280 mcg/kg/day dose per each week respectively up to 5 weeks.
84940|NCT02057692|B2|Baseline|Maralixibat 140 mcg/kg/Day|Participants received mid dose maralixibat 140 mcg/kg/day oral solution for 9 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35, 70 and 140 mcg/kg/day dose per each week respectively up to 4 weeks.
84941|NCT02057692|B1|Baseline|Maralixibat 70 mcg/kg/Day|Participants received low dose maralixibat 70 mcg/kg/day oral solution for 10 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35 and 70 mcg/kg/day dose per each week respectively up to 3 weeks.
84942|NCT02057692|P4|Participant Flow|Placebo|Participants received placebo matched to maralixibat oral solution for 13 weeks (dose escalation and stable dosing period).
84943|NCT02057692|P3|Participant Flow|Maralixibat 280 mcg/kg/Day|Participants received high dose maralixibat 280 mcg/kg/day oral solution for 8 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35, 70, 140 and 280 mcg/kg/day dose per each week respectively up to 5 weeks.
84944|NCT02057692|P2|Participant Flow|Maralixibat 140 mcg/kg/Day|Participants received mid dose maralixibat 140 mcg/kg/day oral solution for 9 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35, 70 and 140 mcg/kg/day dose per each week respectively up to 4 weeks.
84945|NCT02057692|P1|Participant Flow|Maralixibat 70 mcg/kg/Day|Participants received low dose maralixibat 70 mcg/kg/day oral solution for 10 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35 and 70 mcg/kg/day dose per each week respectively up to 3 weeks.
84946|NCT02057692|O5|Outcome|Placebo|Participants received placebo matched to maralixibat oral solution for 13 weeks (dose escalation and stable dosing period).
84947|NCT02057692|O4|Outcome|Maralixibat 280 mcg/kg/Day|Participants received high dose maralixibat 280 mcg/kg/day oral solution for 8 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35, 70, 140 and 280 mcg/kg/day dose per each week respectively up to 5 weeks.
84948|NCT02057692|O3|Outcome|Maralixibat 140 mcg/kg/Day|Participants received mid dose maralixibat 140 mcg/kg/day oral solution for 9 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35, 70 and 140 mcg/kg/day dose per each week respectively up to 4 weeks.
84949|NCT02057692|O2|Outcome|Maralixibat 70 mcg/kg/Day|Participants received low dose maralixibat 70 mcg/kg/day oral solution for 10 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35 and 70 mcg/kg/day dose per each week respectively up to 3 weeks.
84950|NCT02057692|O1|Outcome|Maralixibat 14 mcg/kg/Day|Participants received 14 mcg/kg/day of maralixibat oral solution for 1 week. One participant assigned to the 70μg/kg/day arm, was withdrawn from the study after receiving a single dose of 14 mcg/kg/day dose. TEAE was reported separately for this participant using this arm.
84951|NCT02057692|O4|Outcome|Placebo|Participants received placebo matched to maralixibat oral solution for 13 weeks (dose escalation and stable dosing period).
84952|NCT02057692|O3|Outcome|Maralixibat 280 mcg/kg/Day|Participants received high dose maralixibat 280 mcg/kg/day oral solution for 8 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35, 70, 140 and 280 mcg/kg/day dose per each week respectively up to 5 weeks.
84953|NCT02057692|O2|Outcome|Maralixibat 140 mcg/kg/Day|Participants received mid dose maralixibat 140 mcg/kg/day oral solution for 9 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35, 70 and 140 mcg/kg/day dose per each week respectively up to 4 weeks.
84954|NCT02057692|O1|Outcome|Maralixibat 70 mcg/kg/Day|Participants received low dose maralixibat 70 mcg/kg/day oral solution for 10 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35 and 70 mcg/kg/day dose per each week respectively up to 3 weeks.
84955|NCT02057692|O4|Outcome|Placebo|Participants received placebo matched to maralixibat oral solution for 13 weeks (dose escalation and stable dosing period).
84956|NCT02057692|O3|Outcome|Maralixibat 280 mcg/kg/Day|Participants received high dose maralixibat 280 mcg/kg/day oral solution for 8 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35, 70, 140 and 280 mcg/kg/day dose per each week respectively up to 5 weeks.
84957|NCT02057692|O2|Outcome|Maralixibat 140 mcg/kg/Day|Participants received mid dose maralixibat 140 mcg/kg/day oral solution for 9 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35, 70 and 140 mcg/kg/day dose per each week respectively up to 4 weeks.
84958|NCT02057692|O1|Outcome|Maralixibat 70 mcg/kg/Day|Participants received low dose maralixibat 70 mcg/kg/day oral solution for 10 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35 and 70 mcg/kg/day dose per each week respectively up to 3 weeks.
84959|NCT02057692|O4|Outcome|Placebo|Participants received placebo matched to maralixibat oral solution for 13 weeks (dose escalation and stable dosing period).
84960|NCT02057692|O3|Outcome|Maralixibat 280 mcg/kg/Day|Participants received high dose maralixibat 280 mcg/kg/day oral solution for 8 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35, 70, 140 and 280 mcg/kg/day dose per each week respectively up to 5 weeks.
84961|NCT02057692|O2|Outcome|Maralixibat 140 mcg/kg/Day|Participants received mid dose maralixibat 140 mcg/kg/day oral solution for 9 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35, 70 and 140 mcg/kg/day dose per each week respectively up to 4 weeks.
84962|NCT02057692|O1|Outcome|Maralixibat 70 mcg/kg/Day|Participants received low dose maralixibat 70 mcg/kg/day oral solution for 10 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35 and 70 mcg/kg/day dose per each week respectively up to 3 weeks.
84963|NCT02057692|E5|Reported Event|Placebo|Participants received placebo matched to maralixibat oral solution for 13 weeks (dose escalation and stable dosing period).
85030|NCT02057250|P4|Participant Flow|Sarilumab 200 mg by PFS (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.
84964|NCT02057692|E4|Reported Event|Maralixibat 280 mcg/kg/Day|Participants received high dose maralixibat 280 mcg/kg/day oral solution for 8 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35, 70, 140 and 280 mcg/kg/day dose per each week respectively up to 5 weeks.
84965|NCT02057692|E3|Reported Event|Maralixibat 140 mcg/kg/Day|Participants received mid dose maralixibat 140 mcg/kg/day oral solution for 9 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35, 70 and 140 mcg/kg/day dose per each week respectively up to 4 weeks.
84966|NCT02057692|E2|Reported Event|Maralixibat 70 mcg/kg/Day|Participants received low dose maralixibat 70 mcg/kg/day oral solution for 10 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35 and 70 mcg/kg/day dose per each week respectively up to 3 weeks.
84967|NCT02057692|E1|Reported Event|Maralixibat 14 mcg/kg/Day|Participants received 14 mcg/kg/day of maralixibat oral solution for 1 week. One participant assigned to the 70μg/kg/day arm, was withdrawn from the study after receiving a single dose of 14 mcg/kg/day dose. TEAE was reported separately for this participant using this arm.
84968|NCT02057549|B3|Baseline|Total|Total of all reporting groups
84969|NCT02057549|B2|Baseline|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
84970|NCT02057549|B1|Baseline|Haloperidol Plus Conventional Therapy|Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
84971|NCT02057549|P2|Participant Flow|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
84972|NCT02057549|P1|Participant Flow|Haloperidol Plus Conventional Therapy|Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
84973|NCT02057549|O2|Outcome|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
84974|NCT02057549|O1|Outcome|Haloperidol Plus Conventional Therapy|Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
84975|NCT02057549|O2|Outcome|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
84976|NCT02057549|O1|Outcome|Haloperidol Plus Conventional Therapy|Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
84977|NCT02057549|O2|Outcome|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
84978|NCT02057549|O1|Outcome|Haloperidol Plus Conventional Therapy|Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
84979|NCT02057549|O2|Outcome|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
84980|NCT02057549|O1|Outcome|Haloperidol Plus Conventional Therapy|Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
84981|NCT02057549|O2|Outcome|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
85031|NCT02057250|P3|Participant Flow|Sarilumab 200 mg by AID (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
85032|NCT02057250|P2|Participant Flow|Sarilumab 150 mg by PFS (AID Assessment Phase)|Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.
84982|NCT02057549|O1|Outcome|Haloperidol Plus Conventional Therapy|Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
84983|NCT02057549|O2|Outcome|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
84984|NCT02057549|O1|Outcome|Haloperidol Plus Conventional Therapy|Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
84985|NCT02057549|O2|Outcome|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
84986|NCT02057549|O1|Outcome|Haloperidol Plus Conventional Therapy|Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
84987|NCT02057549|O2|Outcome|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
84988|NCT02057549|O1|Outcome|Haloperidol Plus Conventional Therapy|Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
84989|NCT02057549|E2|Reported Event|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
84990|NCT02057549|E1|Reported Event|Haloperidol Plus Conventional Therapy|Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
84991|NCT02057406|B4|Baseline|Total|Total of all reporting groups
84992|NCT02057406|B3|Baseline|Placebo|"Matched placebo corn oil capsules~Placebo"
84993|NCT02057406|B2|Baseline|High EPA|"Almost pure EPA 2 grams~High EPA"
84994|NCT02057406|B1|Baseline|2:1 EPA/DHA|"400/200 EPA/DHA fish oil 2 grams~2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams"
84995|NCT02057406|P3|Participant Flow|Placebo|"Matched placebo corn oil capsules~Placebo"
84996|NCT02057406|P2|Participant Flow|High EPA|"Almost pure EPA 2 grams~High EPA"
84997|NCT02057406|P1|Participant Flow|2:1 EPA/DHA|"400/200 EPA/DHA fish oil 2 grams~2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid (DHA) fish oil 2 grams"
84998|NCT02057406|O3|Outcome|Placebo|"Matched placebo corn oil capsules~Placebo"
84999|NCT02057406|O2|Outcome|High EPA|"Almost pure EPA 2 grams~High EPA"
85000|NCT02057406|O1|Outcome|2:1 EPA/DHA|"400/200 EPA/DHA fish oil 2 grams~2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams"
85001|NCT02057406|O3|Outcome|Placebo|"Matched placebo corn oil capsules~Placebo"
85002|NCT02057406|O2|Outcome|High EPA|"Almost pure EPA 2 grams~High EPA"
85003|NCT02057406|O1|Outcome|2:1 EPA/DHA|"400/200 EPA/DHA fish oil 2 grams~2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams"
85004|NCT02057406|E3|Reported Event|Placebo|"Matched placebo corn oil capsules~Placebo"
85005|NCT02057406|E2|Reported Event|High EPA|"Almost pure EPA 2 grams~High EPA"
85006|NCT02057406|E1|Reported Event|2:1 EPA/DHA|"400/200 EPA/DHA fish oil 2 grams~2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams"
85007|NCT02057393|B1|Baseline|Indocyanine Green|"Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99.~Indocyanine green: Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node.~Technetium99: Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node.~Methylene blue: Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye."
85033|NCT02057250|P1|Participant Flow|Sarilumab 150 mg by AID (AID Assessment Phase)|Sarilumab 150 mg subcutaneous (SC) injection every 2 weeks (q2w) administered by AID with one or a combination of non-biologic disease-modifying anti-rheumatic drug (DMARD) for 12 weeks.
85034|NCT02057250|O4|Outcome|Sarilumab 200 mg by PFS (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.
85035|NCT02057250|O3|Outcome|Sarilumab 200 mg by AID (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
85008|NCT02057393|P1|Participant Flow|Indocyanine Green|"Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99.~Indocyanine green: Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node.~Technetium99: Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node.~Methylene blue: Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye."
85009|NCT02057393|O1|Outcome|Indocyanine Green|"Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99.~Indocyanine green: Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node.~Technetium99: Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node.~Methylene blue: Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye."
85010|NCT02057393|E1|Reported Event|Indocyanine Green|"Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99.~Indocyanine green: Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node.~Technetium99: Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node.~Methylene blue: Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye."
85011|NCT02057276|B3|Baseline|Total|Total of all reporting groups
85012|NCT02057276|B2|Baseline|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Sham Repetitive Transcranial Magnetic Stimulation~Occupational Therapy"
85013|NCT02057276|B1|Baseline|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.~Occupational Therapy"
85014|NCT02057276|P2|Participant Flow|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Sham Repetitive Transcranial Magnetic Stimulation~Occupational Therapy"
85015|NCT02057276|P1|Participant Flow|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.~Occupational Therapy"
85016|NCT02057276|O2|Outcome|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Sham Repetitive Transcranial Magnetic Stimulation~Occupational Therapy"
85017|NCT02057276|O1|Outcome|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.~Occupational Therapy"
85018|NCT02057276|O2|Outcome|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Sham Repetitive Transcranial Magnetic Stimulation~Occupational Therapy"
85019|NCT02057276|O1|Outcome|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.~Occupational Therapy"
85020|NCT02057276|O2|Outcome|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Sham Repetitive Transcranial Magnetic Stimulation~Occupational Therapy"
85021|NCT02057276|O1|Outcome|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.~Occupational Therapy"
85022|NCT02057276|E2|Reported Event|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Sham Repetitive Transcranial Magnetic Stimulation~Occupational Therapy"
85023|NCT02057276|E1|Reported Event|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.~Occupational Therapy"
85024|NCT02057250|B5|Baseline|Total|Total of all reporting groups
85025|NCT02057250|B4|Baseline|Sarilumab 200 mg by PFS (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.
85026|NCT02057250|B3|Baseline|Sarilumab 200 mg by AID (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
85027|NCT02057250|B2|Baseline|Sarilumab 150 mg by PFS (AID Assessment Phase)|Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.
85028|NCT02057250|B1|Baseline|Sarilumab 150 mg by AID (AID Assessment Phase)|Sarilumab 150 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
85029|NCT02057250|P5|Participant Flow|Sarilumab 150 mg by PFS (Extension Phase)|Participants who completed 12 week AID assessment phase received Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks.
88421|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
85036|NCT02057250|O2|Outcome|Sarilumab 150 mg by PFS (AID Assessment Phase)|Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.
85037|NCT02057250|O1|Outcome|Sarilumab 150 mg by AID (AID Assessment Phase)|Sarilumab 150 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
85038|NCT02057250|O2|Outcome|Sarilumab 200 mg by AID (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
85039|NCT02057250|O1|Outcome|Sarilumab 150 mg by AID (AID Assessment Phase)|Sarilumab 150 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
85040|NCT02057250|E5|Reported Event|Sarilumab 150 mg by PFS (Extension Phase)|Participants who completed 12 week AID assessment phase received Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks.
85041|NCT02057250|E4|Reported Event|Sarilumab 200 mg by PFS (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.
85042|NCT02057250|E3|Reported Event|Sarilumab 200 mg by AID (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
85043|NCT02057250|E2|Reported Event|Sarilumab 150 mg by PFS (AID Assessment Phase)|Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.
85044|NCT02057250|E1|Reported Event|Sarilumab 150 mg by AID (AID Assessment Phase)|Sarilumab 150 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
85045|NCT02057237|B1|Baseline|Single Arm - Mitotane|"Mitotane will be administered on an outpatient or inpatient basis.~Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily"
85046|NCT02057237|P1|Participant Flow|Single Arm - Mitotane|"Mitotane will be administered on an outpatient or inpatient basis.~Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily"
85047|NCT02057237|O1|Outcome|Single Arm - Mitotane|"Mitotane will be administered on an outpatient or inpatient basis.~Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily"
85048|NCT02057237|O1|Outcome|Single Arm|"Mitotane will be administered on an outpatient or inpatient basis.~Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily"
85049|NCT02057237|E1|Reported Event|Single Arm - Mitotane|"Mitotane will be administered on an outpatient or inpatient basis.~Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily"
85050|NCT02057068|B3|Baseline|Total|Total of all reporting groups
85051|NCT02057068|B2|Baseline|Usual Care Group|During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.
85052|NCT02057068|B1|Baseline|SLEEP-E Dyads Intervention|"SLEEP-E Dyads Six-Week Tele-Health Intervention~. Daily core video modules on sleep education, sleep hygiene and behavioral and environmental factors influencing sleep.~. Daily and on-demand video modules designed to promote and provide guided instruction for daily Move Out time consisting of activity enhancement and exercise.~. Daily and on-demand video modules designed to promote and provide guided instruction for daily Stand Down time (meditation, therapeutic breathing and self-care).~. SLEEP-E Dyads book~. Two tele-video conferences to discuss evaluation results, obtain buy-in for the prescribed intervention and address dysfunctional beliefs and attitudes about sleep. The second call involves checking-in, encouragement, reinforcement and coaching~SLEEP-E Dyads Intervention: Described in arm/group description"
85053|NCT02057068|P2|Participant Flow|Wait List Control Group|During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.
85054|NCT02057068|P1|Participant Flow|SLEEP-E Dyads Intervention|"SLEEP-E Dyads Intervention~Adaptive prescriptions for the individualized components of the sleep intervention will be written for each dyad based upon dyad-specific risk factors, sources of sleep disturbance, nature of sleep problems and baseline sleep hygiene practices. In addition, each dyad will receive a core intervention component consisting of a sleep hygiene psycho-education curriculum, activity enhancement and relaxation instruction and training delivered by the iPads and two tele-video conferences to discuss evaluation, obtain buy-in for the intervention and provide coaching."
85055|NCT02057068|O2|Outcome|Usual Care Group|During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.
85056|NCT02057068|O1|Outcome|SLEEP-E Dyads Intervention|"SLEEP-E Dyads Six-Week Tele-Health Intervention~. Daily core video modules on sleep education, sleep hygiene and behavioral and environmental factors influencing sleep.~. Daily and on-demand video modules designed to promote and provide guided instruction for daily Move Out time consisting of activity enhancement and exercise.~. Daily and on-demand video modules designed to promote and provide guided instruction for daily Stand Down time (meditation, therapeutic breathing and self-care).~. SLEEP-E Dyads book~. Two tele-video conferences to discuss evaluation results, obtain buy-in for the prescribed intervention and address dysfunctional beliefs and attitudes about sleep. The second call involves checking-in, encouragement, reinforcement and coaching~SLEEP-E Dyads Intervention: Described in arm/group description"
85057|NCT02057068|O2|Outcome|Usual Care Group|During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.
85091|NCT02056652|O2|Outcome|No Pessary|No pessary will be used. Subjects will receive standard obstetrical management
85218|NCT02055365|O2|Outcome|Day 3|Differentially expressed genes at Day 3 versus pre-vaccination baseline (p<0.05).
85058|NCT02057068|O1|Outcome|SLEEP-E Dyads Intervention|"SLEEP-E Dyads Six-Week Tele-Health Intervention~. Daily core video modules on sleep education, sleep hygiene and behavioral and environmental factors influencing sleep.~. Daily and on-demand video modules designed to promote and provide guided instruction for daily Move Out time consisting of activity enhancement and exercise.~. Daily and on-demand video modules designed to promote and provide guided instruction for daily Stand Down time (meditation, therapeutic breathing and self-care).~. SLEEP-E Dyads book~. Two tele-video conferences to discuss evaluation results, obtain buy-in for the prescribed intervention and address dysfunctional beliefs and attitudes about sleep. The second call involves checking-in, encouragement, reinforcement and coaching~SLEEP-E Dyads Intervention: Described in arm/group description"
85059|NCT02057068|O2|Outcome|Wait List Control Group|During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.
85060|NCT02057068|O1|Outcome|SLEEP-E Dyads Intervention|"SLEEP-E Dyads Intervention~Adaptive prescriptions for the individualized components of the sleep intervention will be written for each dyad based upon dyad-specific risk factors, sources of sleep disturbance, nature of sleep problems and baseline sleep hygiene practices. In addition, each dyad will receive a core intervention component consisting of a sleep hygiene psycho-education curriculum, activity enhancement and relaxation instruction and training delivered by the iPads and two tele-video conferences to discuss evaluation, obtain buy-in for the intervention and provide coaching."
85061|NCT02057068|E2|Reported Event|Wait List Control Group|During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits. There were no adverse events.
85062|NCT02057068|E1|Reported Event|SLEEP-E Dyads Intervention|"SLEEP-E Dyads Intervention~Adaptive prescriptions for the individualized components of the sleep intervention will be written for each dyad based upon dyad-specific risk factors, sources of sleep disturbance, nature of sleep problems and baseline sleep hygiene practices. In addition, each dyad will receive a core intervention component consisting of a sleep hygiene psycho-education curriculum, activity enhancement and relaxation instruction and training delivered by the iPads and two tele-video conferences to discuss evaluation, obtain buy-in for the intervention and provide coaching.~There were no adverse events."
85063|NCT02056834|B1|Baseline|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
85064|NCT02056834|P1|Participant Flow|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
85065|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
85066|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
85067|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
85068|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
85069|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
85070|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
85071|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
85072|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
85073|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
85074|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
85075|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
85076|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
85077|NCT02056834|O1|Outcome|chronOS Inject|"Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect~chronOS Inject: chronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures"
85078|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
85079|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
85080|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
85081|NCT02056834|E1|Reported Event|chronOS Inject|"Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect~chronOS Inject: chronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures"
85082|NCT02056652|B3|Baseline|Total|Total of all reporting groups
85083|NCT02056652|B2|Baseline|No Pessary|No pessary will be used. Subjects will receive standard obstetrical management
85084|NCT02056652|B1|Baseline|Pessary|"Use of the Bioteque cup pessary. Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)~Bioteque cup pessary"
85085|NCT02056652|P2|Participant Flow|No Pessary|No pessary will be used. Subjects will receive standard obstetrical management
85086|NCT02056652|P1|Participant Flow|Pessary|"Use of the Bioteque cup pessary. Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)~Bioteque cup pessary"
85087|NCT02056652|O2|Outcome|No Pessary|No pessary will be used. Subjects will receive standard obstetrical management
85088|NCT02056652|O1|Outcome|Pessary|"Use of the Bioteque cup pessary. Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)~Bioteque cup pessary"
85089|NCT02056652|O2|Outcome|No Pessary|No pessary will be used. Subjects will receive standard obstetrical management
85090|NCT02056652|O1|Outcome|Pessary|"Use of the Bioteque cup pessary. Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)~Bioteque cup pessary"
85092|NCT02056652|O1|Outcome|Pessary|"Use of the Bioteque cup pessary. Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)~Bioteque cup pessary"
85093|NCT02056652|O2|Outcome|No Pessary|No pessary will be used. Subjects will receive standard obstetrical management
85094|NCT02056652|O1|Outcome|Pessary|"Use of the Bioteque cup pessary. Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)~Bioteque cup pessary"
85095|NCT02056652|O2|Outcome|No Pessary|No pessary will be used. Subjects will receive standard obstetrical management
85096|NCT02056652|O1|Outcome|Pessary|"Use of the Bioteque cup pessary. Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)~Bioteque cup pessary"
85097|NCT02056652|O2|Outcome|No Pessary|No pessary will be used. Subjects will receive standard obstetrical management
85098|NCT02056652|O1|Outcome|Pessary|"Use of the Bioteque cup pessary. Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)~Bioteque cup pessary"
85099|NCT02056652|E2|Reported Event|No Pessary|No pessary will be used. Subjects will receive standard obstetrical management
85100|NCT02056652|E1|Reported Event|Pessary|"Use of the Bioteque cup pessary. Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)~Bioteque cup pessary"
85101|NCT02056639|B3|Baseline|Total|Total of all reporting groups
85102|NCT02056639|B2|Baseline|No Pessary|No pessary will be used. Subjects will receive standard obstetrical management
85103|NCT02056639|B1|Baseline|Pessary|"Use of the Bioteque cup pessary. Pessary will be placed between 18 and 27 6/7 weeks gestation, and will be removed during the 36th week of pregnancy (or earlier if indicated)~Bioteque cup pessary"
85104|NCT02056639|P2|Participant Flow|No Pessary|No pessary will be used. Subjects will receive standard obstetrical management
85105|NCT02056639|P1|Participant Flow|Pessary|"Use of the Bioteque cup pessary. Pessary will be placed between 18 and 27 6/7 weeks gestation, and will be removed during the 36th week of pregnancy (or earlier if indicated)~Bioteque cup pessary"
85106|NCT02056639|O2|Outcome|No Pessary|No pessary will be used. Subjects will receive standard obstetrical management
85107|NCT02056639|O1|Outcome|Pessary|"Use of the Bioteque cup pessary. Pessary will be placed between 18 and 27 6/7 weeks gestation, and will be removed during the 36th week of pregnancy (or earlier if indicated)~Bioteque cup pessary"
85108|NCT02056639|O2|Outcome|No Pessary|No pessary will be used. Subjects will receive standard obstetrical management
85109|NCT02056639|O1|Outcome|Pessary|"Use of the Bioteque cup pessary. Pessary will be placed between 18 and 27 6/7 weeks gestation, and will be removed during the 36th week of pregnancy (or earlier if indicated)~Bioteque cup pessary"
85110|NCT02056639|O2|Outcome|No Pessary|No pessary will be used. Subjects will receive standard obstetrical management
85111|NCT02056639|O1|Outcome|Pessary|"Use of the Bioteque cup pessary. Pessary will be placed between 18 and 27 6/7 weeks gestation, and will be removed during the 36th week of pregnancy (or earlier if indicated)~Bioteque cup pessary"
85112|NCT02056639|O2|Outcome|No Pessary|No pressary will be inserted and subjects will follow standard of care.
85113|NCT02056639|O1|Outcome|Pessary|A biotec. pessary will be placed in subjects.
85114|NCT02056639|O2|Outcome|No Pessary|No pessary will be used. Subjects will receive standard obstetrical management
85115|NCT02056639|O1|Outcome|Pessary|"Use of the Bioteque cup pessary. Pessary will be placed between 18 and 27 6/7 weeks gestation, and will be removed during the 36th week of pregnancy (or earlier if indicated)~Bioteque cup pessary"
85116|NCT02056639|E2|Reported Event|No Pessary|No pessary will be used. Subjects will receive standard obstetrical management
85117|NCT02056639|E1|Reported Event|Pessary|"Use of the Bioteque cup pessary. Pessary will be placed between 18 and 27 6/7 weeks gestation, and will be removed during the 36th week of pregnancy (or earlier if indicated)~Bioteque cup pessary"
85118|NCT02056431|B3|Baseline|Total|Total of all reporting groups
85119|NCT02056431|B2|Baseline|IVR Control Group|Participants will receive 3 non-interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) containing general messages regarding diabetic education.
85120|NCT02056431|B1|Baseline|IVR Intervention Group|"Participants will receive 3 interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) to collect information on medication use, side effects, rating of side effects, and pain symptoms to be fed back to their physicians.~IVR Intervention Group: 595 participants will receive 3 interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) to collect information on medication use, side effects, rating of side effects, and pain symptoms to be fed back to their physicians."
85121|NCT02056431|P2|Participant Flow|IVR Control Group|Participants will receive 3 non-interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) containing general messages regarding diabetic education.
85122|NCT02056431|P1|Participant Flow|IVR Intervention Group|Participants will receive 3 interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) to collect information on medication use, side effects, rating of side effects, and pain symptoms to be fed back to their physicians.
85123|NCT02056431|O2|Outcome|IVR Intervention Group|Participants will receive 3 interactive voice response (IVR) calls (2nd, 4th,and 6th months post start date) to collect information on medication use, side effects, rating of side effects and pain symptoms to be fed back to their physicians
85124|NCT02056431|O1|Outcome|IVR Control Group|Participants will receive 3 non-interactive voice response (IVR) calls (2nd, 4th,and 6th months post start date) containing generic messages regarding diabetes education
85125|NCT02056431|O2|Outcome|IVR Control Group|Participants will receive 3 non-interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) containing general messages regarding diabetic education.
85126|NCT02056431|O1|Outcome|IVR Intervention Group|Participants will receive 3 interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) to collect information on medication use, side effects, rating of side effects, and pain symptoms to be fed back to their physicians.
85214|NCT02055365|O2|Outcome|Day 3|Significantly Differentially expressed genes at Day 3 versus pre-vaccination baseline (FDR<0.05).
85127|NCT02056431|E2|Reported Event|IVR Control Group|Participants will receive 3 non-interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) containing general messages regarding diabetic education.
85128|NCT02056431|E1|Reported Event|IVR Intervention Group|"Participants will receive 3 interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) to collect information on medication use, side effects, rating of side effects, and pain symptoms to be fed back to their physicians.~IVR Intervention Group: Participants will receive 3 interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) to collect information on medication use, side effects, rating of side effects, and pain symptoms to be fed back to their physicians."
85129|NCT02056392|B7|Baseline|Total|Total of all reporting groups
85130|NCT02056392|B6|Baseline|Selumetinib/Selumetinib Placebo/Moxifloxacin|
85131|NCT02056392|B5|Baseline|Selumetinib Placebo/Selumetinib/Moxifloxacin|
85132|NCT02056392|B4|Baseline|Selumetinib Placebo/Moxifloxacin/Selumetinib|
85133|NCT02056392|B3|Baseline|Moxifloxacin/Selumetinib Placebo/Selumetinib|
85134|NCT02056392|B2|Baseline|Moxifloxacin/Selumetinib/Selumetinib Placebo|
85135|NCT02056392|B1|Baseline|Selumetinib/Moxifloxacin/Selumetinib Placebo|
85136|NCT02056392|P6|Participant Flow|Selumetinib/Selumetinib Placebo/Moxifloxacin|
85137|NCT02056392|P5|Participant Flow|Selumetinib Placebo/Selumetinib/Moxifloxacin|
85138|NCT02056392|P4|Participant Flow|Selumetinib Placebo/Moxifloxacin/Selumetinib|
85139|NCT02056392|P3|Participant Flow|Moxifloxacin/Selumetinib Placebo/Selumetinib|
85140|NCT02056392|P2|Participant Flow|Moxifloxacin/Selumetinib/Selumetinib Placebo|
85141|NCT02056392|P1|Participant Flow|Selumetinib/Moxifloxacin/Selumetinib Placebo|
85142|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
85143|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
85144|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
85145|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
85146|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
85147|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
85148|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
85149|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
85150|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
85151|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
85152|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
85153|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
85154|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
85155|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
85156|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
85157|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
85158|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
85159|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
85160|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
85161|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
85162|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
85163|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
85164|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
85165|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
85166|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
85167|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
85168|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
85169|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
85170|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
85171|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
85172|NCT02056392|E3|Reported Event|Placebo|Selumetinib placebo (3 capsules)
85173|NCT02056392|E2|Reported Event|Moxifloxacin|Moxiflxacin 400 mg (open label)
85174|NCT02056392|E1|Reported Event|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
85175|NCT02056171|B3|Baseline|Total|Total of all reporting groups
85176|NCT02056171|B2|Baseline|Placebo|"A randomized group will receive placebo, and not quetiapine.~Placebo: Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo."
85177|NCT02056171|B1|Baseline|Quetiapine|"A randomized group will receive quetiapine as treatment for delirium.~Quetiapine: Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine."
85178|NCT02056171|P2|Participant Flow|Placebo|"A randomized group will receive placebo, and not quetiapine.~Placebo: Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo."
85179|NCT02056171|P1|Participant Flow|Quetiapine|"A randomized group will receive quetiapine as treatment for delirium.~Quetiapine: Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine."
85180|NCT02056171|O2|Outcome|Placebo|"A randomized group will receive placebo, and not quetiapine.~Placebo: Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo."
85181|NCT02056171|O1|Outcome|Quetiapine|"A randomized group will receive quetiapine as treatment for delirium.~Quetiapine: Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine."
85182|NCT02056171|O2|Outcome|Placebo|"A randomized group will receive placebo, and not quetiapine.~Placebo: Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo."
85183|NCT02056171|O1|Outcome|Quetiapine|"A randomized group will receive quetiapine as treatment for delirium.~Quetiapine: Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine."
85184|NCT02056171|O2|Outcome|Placebo|"A randomized group will receive placebo, and not quetiapine.~Placebo: Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo."
85185|NCT02056171|O1|Outcome|Quetiapine|"A randomized group will receive quetiapine as treatment for delirium.~Quetiapine: Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine."
85186|NCT02056171|E2|Reported Event|Placebo|"A randomized group will receive placebo, and not quetiapine.~Placebo: Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo."
85187|NCT02056171|E1|Reported Event|Quetiapine|"A randomized group will receive quetiapine as treatment for delirium.~Quetiapine: Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine."
85188|NCT02055430|B3|Baseline|Total|Total of all reporting groups
85189|NCT02055430|B2|Baseline|Bilateral Double J Ureteric Stents|"double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management.~bilateral double J ureteric stent: The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
85190|NCT02055430|B1|Baseline|Percutaneous Nephrostomy|"percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.~percutaneous nephrostomy insertion: The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
85191|NCT02055430|P2|Participant Flow|Bilateral Double J Ureteric Stents|"double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management.~bilateral double J ureteric stent: The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
85192|NCT02055430|P1|Participant Flow|Percutaneous Nephrostomy|"percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.~percutaneous nephrostomy insertion: The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
85193|NCT02055430|O2|Outcome|Bilateral Double J Ureteric Stents|"double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management.~bilateral double J ureteric stent: The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
85194|NCT02055430|O1|Outcome|Percutaneous Nephrostomy|"percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.~percutaneous nephrostomy insertion: The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
85195|NCT02055430|E2|Reported Event|Bilateral Double J Ureteric Stents|"double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management.~bilateral double J ureteric stent: The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
85196|NCT02055430|E1|Reported Event|Percutaneous Nephrostomy|"percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.~percutaneous nephrostomy insertion: The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
85197|NCT02055404|B1|Baseline|Overall Study|Delefilcon A spherical contact lens with molded marks and etafilcon A toric contact lens worn contralaterally (1 in each eye) for approximately 2 hours
85198|NCT02055404|P1|Participant Flow|Overall Study|Delefilcon A spherical contact lens with molded marks and etafilcon A toric contact lens worn contralaterally (1 in each eye) for approximately 2 hours
85199|NCT02055404|O9|Outcome|Control|Etafilcon A toric contact lens
85200|NCT02055404|O8|Outcome|S8 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
85201|NCT02055404|O7|Outcome|S7 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
85202|NCT02055404|O6|Outcome|S6 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
85203|NCT02055404|O5|Outcome|S5 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
85204|NCT02055404|O4|Outcome|S4 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
85205|NCT02055404|O3|Outcome|S3 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
85206|NCT02055404|O2|Outcome|S2 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
85207|NCT02055404|O1|Outcome|S1 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
85208|NCT02055404|E2|Reported Event|Etafilcon A|Etafilcon A toric contact lens randomly assigned to one eye, with delefilcon A spherical contact lens with molded marks in the fellow eye for contralateral wear approximately 2 hours in duration
85209|NCT02055404|E1|Reported Event|Delefilcon A|Delefilcon A spherical contact lens with molded marks randomly assigned to one eye, with etafilcon A toric contact lens in the fellow eye for contralateral wear approximately 2 hours in duration.
85210|NCT02055365|B1|Baseline|Hepatitis B Vaccination|"All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant).~Hepatitis B Vaccine (Recombinant): All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant)."
85211|NCT02055365|P1|Participant Flow|Hepatitis B Vaccination|"All subjects will receive the standard 3-dose course of Recombivax Hepatitis B (HB) (Merck) - Hepatitis B Vaccine (Recombinant).~Hepatitis B Vaccine (Recombinant): All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant)."
85212|NCT02055365|O4|Outcome|Week 2|Significantly Differentially expressed genes at Week 2 versus pre-vaccination baseline (FDR<0.05).
85213|NCT02055365|O3|Outcome|Week 1|Significantly Differentially expressed genes at Week 1 versus pre-vaccination baseline (FDR<0.05).
88422|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
85219|NCT02055365|O1|Outcome|Day 1|Differentially expressed genes at Day 1 versus pre-vaccination baseline (p<0.05).
85220|NCT02055365|E1|Reported Event|Hepatitis B Vaccination|"All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant).~Hepatitis B Vaccine (Recombinant): All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant)."
85221|NCT02055352|B3|Baseline|Total|Total of all reporting groups
85222|NCT02055352|B2|Baseline|Fluticasone / Salmeterol|Fixed combination of fluticasone and salmeterol
85223|NCT02055352|B1|Baseline|Budesonide/Indacaterol|Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
85224|NCT02055352|P2|Participant Flow|Fluticasone / Salmeterol|Fixed combination of fluticasone and salmeterol
85225|NCT02055352|P1|Participant Flow|Budesonide/Indacaterol|Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
85226|NCT02055352|O2|Outcome|Fluticasone / Salmeterol|Fixed combination of fluticasone and salmeterol
85227|NCT02055352|O1|Outcome|Budesonide/Indacaterol|Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
85228|NCT02055352|O2|Outcome|Fluticasone / Salmeterol|Fixed combination of fluticasone and salmeterol
85229|NCT02055352|O1|Outcome|Budesonide/Indacaterol|Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
85230|NCT02055352|O2|Outcome|Fluticasone / Salmeterol|Fixed combination of fluticasone and salmeterol
85231|NCT02055352|O1|Outcome|Budesonide/Indacaterol|Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
85232|NCT02055352|O2|Outcome|Fluticasone / Salmeterol|Fixed combination of fluticasone and salmeterol
85233|NCT02055352|O1|Outcome|Budesonide/Indacaterol|Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
85234|NCT02055352|O2|Outcome|Fluticasone / Salmeterol|Fixed combination of fluticasone and salmeterol
85235|NCT02055352|O1|Outcome|Budesonide/Indacaterol|Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
85236|NCT02055352|E2|Reported Event|Fluticasone / Salmeterol (B)|Fluticasone / Salmeterol (B)
85237|NCT02055352|E1|Reported Event|Budesonide / Indacaterol (A)|Budesonide / Indacaterol (A)
85238|NCT02054910|B3|Baseline|Total|Total of all reporting groups
85239|NCT02054910|B2|Baseline|Sham|"A celiac plexus block will not be administered for pain management~Sham"
85240|NCT02054910|B1|Baseline|Celiac Plexus Block|"Celiac Plexus Block will be administered following EUS~Celiac Plexus Block"
85241|NCT02054910|P2|Participant Flow|Sham|"A celiac plexus block will not be administered for pain management~Sham"
85242|NCT02054910|P1|Participant Flow|Celiac Plexus Block|"Celiac Plexus Block will be administered following EUS~Celiac Plexus Block"
85243|NCT02054910|O2|Outcome|Sham|A celiac plexus block will not be administered for pain management
85244|NCT02054910|O1|Outcome|Celiac Plexus Block|Celiac Plexus Block will be administered following EUS
85245|NCT02054910|O2|Outcome|Sham|A celiac plexus block will not be administered for pain management
85246|NCT02054910|O1|Outcome|Celiac Plexus Block|Celiac Plexus Block will be administered following EUS
85247|NCT02054910|O2|Outcome|Sham|A celiac plexus block will not be administered for pain management
85248|NCT02054910|O1|Outcome|Celiac Plexus Block|Celiac Plexus Block will be administered following EUS
85249|NCT02054910|O2|Outcome|Sham|A celiac plexus block will not be administered for pain management
85250|NCT02054910|O1|Outcome|Celiac Plexus Block|Celiac Plexus Block will be administered following EUS
85251|NCT02054910|O2|Outcome|Sham|"A celiac plexus block will not be administered for pain management~Sham"
85252|NCT02054910|O1|Outcome|Celiac Plexus Block|"Celiac Plexus Block will be administered following EUS~Celiac Plexus Block"
85253|NCT02054910|O2|Outcome|Sham|"A celiac plexus block will not be administered for pain management~Sham"
85254|NCT02054910|O1|Outcome|Celiac Plexus Block|"Celiac Plexus Block will be administered following EUS~Celiac Plexus Block"
85255|NCT02054910|E2|Reported Event|Sham|"A celiac plexus block will not be administered for pain management~Sham"
85256|NCT02054910|E1|Reported Event|Celiac Plexus Block|"Celiac Plexus Block will be administered following EUS~Celiac Plexus Block"
85257|NCT02054897|B4|Baseline|Total|Total of all reporting groups
85258|NCT02054897|B3|Baseline|Placebo|"Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.~Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.~Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period."
85259|NCT02054897|B2|Baseline|Semaglutide 1.0 mg|Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
85260|NCT02054897|B1|Baseline|Semaglutide 0.5 mg|Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
85313|NCT02054715|O1|Outcome|Arm I (Print Educational)|"Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the NCI booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials.~print educational intervention: print educational intervention"
85261|NCT02054897|P3|Participant Flow|Placebo|"Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.~Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.~Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period."
85262|NCT02054897|P2|Participant Flow|Semaglutide 1.0 mg|Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
85263|NCT02054897|P1|Participant Flow|Semaglutide 0.5 mg|Subjects were given 0.25 mg semaglutide once weekly subcutaneous (s.c.; under the skin) injections for 4 weeks followed by 0.5 mg semaglutide once weekly for the remaining 26 weeks of the treatment period.
85264|NCT02054897|O3|Outcome|Placebo|"Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.~Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.~Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period."
85265|NCT02054897|O2|Outcome|Semaglutide 1.0 mg|Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
85266|NCT02054897|O1|Outcome|Semaglutide 0.5 mg|Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
85267|NCT02054897|O3|Outcome|Placebo|"Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.~Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.~Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period."
85268|NCT02054897|O2|Outcome|Semaglutide 1.0 mg|Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
85269|NCT02054897|O1|Outcome|Semaglutide 0.5 mg|Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
85270|NCT02054897|O3|Outcome|Placebo|"Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.~Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.~Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period."
85271|NCT02054897|O2|Outcome|Semaglutide 1.0 mg|Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
85272|NCT02054897|O1|Outcome|Semaglutide 0.5 mg|Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
85273|NCT02054897|O3|Outcome|Placebo|"Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.~Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.~Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period."
85274|NCT02054897|O2|Outcome|Semaglutide 1.0 mg|Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
85275|NCT02054897|O1|Outcome|Semaglutide 0.5 mg|Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
85276|NCT02054897|O3|Outcome|Placebo|"Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.~Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.~Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period."
85277|NCT02054897|O2|Outcome|Semaglutide 1.0 mg|Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
85278|NCT02054897|O1|Outcome|Semaglutide 0.5 mg|Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
85455|NCT02053753|O2|Outcome|Denosumab CP2|Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
85279|NCT02054897|O3|Outcome|Placebo|"Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.~Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.~Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period."
85280|NCT02054897|O2|Outcome|Semaglutide 1.0 mg|Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
85281|NCT02054897|O1|Outcome|Semaglutide 0.5 mg|Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
85282|NCT02054897|E3|Reported Event|Placebo|"Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.~Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.~Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period."
85283|NCT02054897|E2|Reported Event|Semaglutide 1.0 mg|Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
85284|NCT02054897|E1|Reported Event|Semaglutide 0.5 mg|Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
85285|NCT02054754|B3|Baseline|Total|Total of all reporting groups
85286|NCT02054754|B2|Baseline|Placebo|"Single oral dose of matching placebo~Placebo"
85287|NCT02054754|B1|Baseline|Dexanabinol|"Single oral dose of dexanabinol~Dexanabinol: Oral formulation of dexanabinol"
85288|NCT02054754|P6|Participant Flow|Placebo|"Single oral dose of matching placebo~Placebo"
85289|NCT02054754|P5|Participant Flow|Dexanabinol Dose Level 5|"Single oral dose of dexanabinol at Dose level 5~Dexanabinol: Oral formulation of dexanabinol"
85290|NCT02054754|P4|Participant Flow|Dexanabinol Dose Level 4|"Single oral dose of dexanabinol at Dose level 4~Dexanabinol: Oral formulation of dexanabinol"
85291|NCT02054754|P3|Participant Flow|Dexanabinol Dose Level 3|"Single oral dose of dexanabinol at Dose level 3~Dexanabinol: Oral formulation of dexanabinol"
85292|NCT02054754|P2|Participant Flow|Dexanabinol Dose Level 2|"Single oral dose of dexanabinol at Dose level 2~Dexanabinol: Oral formulation of dexanabinol"
85293|NCT02054754|P1|Participant Flow|Dexanabinol Dose Level 1|"Single oral dose of dexanabinol at Dose Level 1~Dexanabinol: Oral formulation of dexanabinol"
85294|NCT02054754|O5|Outcome|Dose Level 5|
85295|NCT02054754|O4|Outcome|Dose Level 4|
85296|NCT02054754|O3|Outcome|Dose Level 3|
85297|NCT02054754|O2|Outcome|Dose Level 2|
85298|NCT02054754|O1|Outcome|Dexanabinol Dose Level 1|
85299|NCT02054754|O2|Outcome|Placebo|"Single oral dose of matching placebo~Placebo"
85300|NCT02054754|O1|Outcome|Dexanabinol|"Single oral dose of dexanabinol~Dexanabinol: Oral formulation of dexanabinol"
85301|NCT02054754|E6|Reported Event|Placebo|"Single oral dose of matching placebo~Placebo"
85302|NCT02054754|E5|Reported Event|Dexanabinol Dose Level 5|"Single oral dose of dexanabinol~Dexanabinol: Oral formulation of dexanabinol"
85303|NCT02054754|E4|Reported Event|Dexanabinol Dose Level 4|"Single oral dose of dexanabinol~Dexanabinol: Oral formulation of dexanabinol"
85304|NCT02054754|E3|Reported Event|Dexanabinol Dose Level 3|"Single oral dose of dexanabinol~Dexanabinol: Oral formuulation of dexanabinol"
85305|NCT02054754|E2|Reported Event|Dexanabinol Dose Level 2|"Single oral dose of dexanabinol~Dexanabinol: Oral formulation of dexanabinol"
85306|NCT02054754|E1|Reported Event|Dexanabinol Dose Level 1|"Single oral dose of dexanabinol~Dexanabinol: Oral formulation of dexanabinol"
85307|NCT02054715|B3|Baseline|Total|Total of all reporting groups
85308|NCT02054715|B2|Baseline|Arm II (Multimedia Psychoeducational)|"Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a DVD and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home.~multimedia psychoeducational intervention: multimedia psychoeducational intervention"
85309|NCT02054715|B1|Baseline|Arm I (Print Educational)|"Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the NCI booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials.~print educational intervention: print educational intervention"
85310|NCT02054715|P2|Participant Flow|Arm II (Multimedia Psychoeducational)|"Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a DVD and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home.~multimedia psychoeducational intervention: multimedia psychoeducational intervention"
85311|NCT02054715|P1|Participant Flow|Arm I (Print Educational)|"Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the NCI booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials.~print educational intervention: print educational intervention"
85312|NCT02054715|O2|Outcome|Arm II (Multimedia Psychoeducational)|"Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a DVD and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home.~multimedia psychoeducational intervention: multimedia psychoeducational intervention"
85314|NCT02054715|O2|Outcome|Arm II (Multimedia Psychoeducational)|"Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a DVD and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home.~multimedia psychoeducational intervention: multimedia psychoeducational intervention"
85315|NCT02054715|O1|Outcome|Arm I (Print Educational)|"Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the NCI booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials.~print educational intervention: print educational intervention"
85316|NCT02054715|O2|Outcome|Arm II (Multimedia Psychoeducational)|"Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a DVD and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home.~multimedia psychoeducational intervention: multimedia psychoeducational intervention"
85317|NCT02054715|O1|Outcome|Arm I (Print Educational)|"Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the NCI booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials.~print educational intervention: print educational intervention"
85318|NCT02054715|O2|Outcome|Arm II (Multimedia Psychoeducational)|"Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a DVD and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home.~multimedia psychoeducational intervention: multimedia psychoeducational intervention"
85319|NCT02054715|O1|Outcome|Arm I (Print Educational)|"Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the NCI booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials.~print educational intervention: print educational intervention"
85320|NCT02054715|E2|Reported Event|Arm II (Multimedia Psychoeducational)|"Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a DVD and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home.~multimedia psychoeducational intervention: multimedia psychoeducational intervention"
85321|NCT02054715|E1|Reported Event|Arm I (Print Educational)|"Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the NCI booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials.~print educational intervention: print educational intervention"
85322|NCT02054702|B3|Baseline|Total|Total of all reporting groups
85323|NCT02054702|B2|Baseline|Arpiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
85324|NCT02054702|B1|Baseline|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
85325|NCT02054702|P2|Participant Flow|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
85326|NCT02054702|P1|Participant Flow|Brexpiprazole|Participants were administered brexpiprazole tablets orally, once daily (QD) starting dose at 1 milligram per day (mg/day) for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
85327|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
85328|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
85329|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
85330|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
85331|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
85332|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
85333|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
85334|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
85335|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
85336|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
85337|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
88423|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
85338|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
85339|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
85340|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
85341|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
85342|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
85343|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
85344|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
85345|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
85346|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
85347|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
85348|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
85349|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
85350|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
85351|NCT02054702|E2|Reported Event|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
85352|NCT02054702|E1|Reported Event|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
85353|NCT02054572|B1|Baseline|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
85354|NCT02054572|P1|Participant Flow|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
85355|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
85356|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
85357|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
85358|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
85359|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
85360|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
85361|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
85362|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
85363|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
85364|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
85365|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
85366|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
85367|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
85368|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
85369|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
85370|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
85371|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
85372|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
85373|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
85374|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
85375|NCT02054572|E1|Reported Event|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by IV bolus at the end of hemodialysis on day 1.
85376|NCT02054481|B5|Baseline|Total|Total of all reporting groups
85377|NCT02054481|B4|Baseline|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
85378|NCT02054481|B3|Baseline|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
85379|NCT02054481|B2|Baseline|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
85380|NCT02054481|B1|Baseline|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
85381|NCT02054481|P4|Participant Flow|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
85382|NCT02054481|P3|Participant Flow|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
85383|NCT02054481|P2|Participant Flow|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
85384|NCT02054481|P1|Participant Flow|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
85385|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
85386|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
85387|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
85388|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
85389|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
85390|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
85391|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
85392|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
85393|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
85394|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
85395|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
85396|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
85397|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
85398|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
85399|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
85400|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
85401|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
85402|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
85403|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
85404|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
85405|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
85406|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
85407|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
85408|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
85409|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
85410|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
85411|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
85412|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
85413|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
85414|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
85415|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
85416|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
85417|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
85418|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
85419|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
85420|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
85421|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
85422|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
85423|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
85424|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
85425|NCT02054481|E4|Reported Event|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
85426|NCT02054481|E3|Reported Event|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
85456|NCT02053753|O1|Outcome|Denosumab CP4|Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
85427|NCT02054481|E2|Reported Event|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
85428|NCT02054481|E1|Reported Event|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
85429|NCT02054325|B3|Baseline|Total|Total of all reporting groups
85430|NCT02054325|B2|Baseline|Glucose|"An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.~Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
85431|NCT02054325|B1|Baseline|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.~Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
85432|NCT02054325|P2|Participant Flow|Glucose|"An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.~Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
85433|NCT02054325|P1|Participant Flow|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.~Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
85434|NCT02054325|O2|Outcome|Glucose|"An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.~Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
85435|NCT02054325|O1|Outcome|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.~Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
85436|NCT02054325|O2|Outcome|Glucose|"An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.~Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
85437|NCT02054325|O1|Outcome|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.~Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
85438|NCT02054325|E2|Reported Event|Glucose|"An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.~Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
85439|NCT02054325|E1|Reported Event|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.~Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
85440|NCT02053753|B3|Baseline|Total|Total of all reporting groups
85441|NCT02053753|B2|Baseline|Denosumab CP2|Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
85442|NCT02053753|B1|Baseline|Denosumab CP4|Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
85443|NCT02053753|P2|Participant Flow|Denosumab CP2|Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
85444|NCT02053753|P1|Participant Flow|Denosumab CP4|Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
85445|NCT02053753|O2|Outcome|Denosumab CP2|Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
85446|NCT02053753|O1|Outcome|Denosumab CP4|Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
85447|NCT02053753|O2|Outcome|Denosumab CP2|Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
85448|NCT02053753|O1|Outcome|Denosumab CP4|Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
85449|NCT02053753|O2|Outcome|Denosumab CP2|Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
85450|NCT02053753|O1|Outcome|Denosumab CP4|Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
85451|NCT02053753|O2|Outcome|Denosumab CP2|Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
85452|NCT02053753|O1|Outcome|Denosumab CP4|Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
85453|NCT02053753|O2|Outcome|Denosumab CP2|Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
85454|NCT02053753|O1|Outcome|Denosumab CP4|Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
85457|NCT02053753|O2|Outcome|Denosumab CP2|Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
85458|NCT02053753|O1|Outcome|Denosumab CP4|Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
85459|NCT02053753|O2|Outcome|Denosumab CP2|Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
85460|NCT02053753|O1|Outcome|Denosumab CP4|Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
85461|NCT02053753|O2|Outcome|Denosumab CP2|Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
85462|NCT02053753|O1|Outcome|Denosumab CP4|Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
85463|NCT02053753|E2|Reported Event|Denosumab CP2|Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
85464|NCT02053753|E1|Reported Event|Denosumab CP4|Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
85465|NCT02053610|B3|Baseline|Total|Total of all reporting groups
85466|NCT02053610|B2|Baseline|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
85467|NCT02053610|B1|Baseline|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
85468|NCT02053610|P2|Participant Flow|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
85469|NCT02053610|P1|Participant Flow|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
85470|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
85471|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
85472|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
85473|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
85474|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
85475|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
85476|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
85477|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
85478|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
85479|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
85480|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
85481|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
85482|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
85746|NCT02051686|B2|Baseline|Placebo|Patients in the control group received an equal volume and rate of normal saline.
85483|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
85484|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
85485|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
85486|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
85487|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
85488|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
85489|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
85490|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
85491|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
85492|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
85493|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
85494|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
85495|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
85496|NCT02053610|E2|Reported Event|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
85497|NCT02053610|E1|Reported Event|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
85498|NCT02053493|B3|Baseline|Total|Total of all reporting groups
85499|NCT02053493|B2|Baseline|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
85500|NCT02053493|B1|Baseline|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
85501|NCT02053493|P2|Participant Flow|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
85502|NCT02053493|P1|Participant Flow|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
85503|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
88424|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
85504|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
85505|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
85506|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
85507|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
85508|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
85509|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
85510|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
85511|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
85512|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
85513|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
85514|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
85515|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
85516|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
85517|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
85518|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
85519|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
85578|NCT02052752|O3|Outcome|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
88425|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
85520|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
85521|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
85522|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
85523|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
85524|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
85525|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
85526|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
85527|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
85528|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
85529|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
85530|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
85531|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
85532|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
85533|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
85534|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
85535|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
85579|NCT02052752|O2|Outcome|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
85536|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
85537|NCT02053493|E2|Reported Event|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
85538|NCT02053493|E1|Reported Event|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
85539|NCT02053168|B1|Baseline|Resorbable Mesh|"Phasix Mesh~Resorbable Mesh: Phasix Mesh"
85540|NCT02053168|P1|Participant Flow|Resorbable Mesh|"Phasix Mesh~Resorbable Mesh: Phasix Mesh"
85541|NCT02053168|O1|Outcome|Resorbable Mesh|"Phasix Mesh~Resorbable Mesh: Phasix Mesh"
85542|NCT02053168|O1|Outcome|Resorbable Mesh|"Phasix Mesh~Resorbable Mesh: Phasix Mesh"
85543|NCT02053168|O1|Outcome|Resorbable Mesh|"Phasix Mesh~Resorbable Mesh: Phasix Mesh"
85544|NCT02053168|O1|Outcome|Resorbable Mesh|"Phasix Mesh~Resorbable Mesh: Phasix Mesh"
85545|NCT02053168|O1|Outcome|Resorbable Mesh|"Phasix Mesh~Resorbable Mesh: Phasix Mesh"
85546|NCT02053168|O1|Outcome|Resorbable Mesh|"Phasix Mesh~Resorbable Mesh: Phasix Mesh"
85547|NCT02053168|O1|Outcome|Resorbable Mesh|"Phasix Mesh~Resorbable Mesh: Phasix Mesh"
85548|NCT02053168|O1|Outcome|Resorbable Mesh|"Phasix Mesh~Resorbable Mesh: Phasix Mesh"
85549|NCT02053168|O1|Outcome|Resorbable Mesh|"Phasix Mesh~Resorbable Mesh: Phasix Mesh"
85550|NCT02053168|O1|Outcome|Resorbable Mesh|"Phasix Mesh~Resorbable Mesh: Phasix Mesh"
85551|NCT02053168|O1|Outcome|Resorbable Mesh|"Phasix Mesh~Resorbable Mesh: Phasix Mesh"
85552|NCT02053168|E1|Reported Event|Resorbable Mesh|"Phasix Mesh~Resorbable Mesh: Phasix Mesh"
85553|NCT02052895|B4|Baseline|Total|Total of all reporting groups
85554|NCT02052895|B3|Baseline|End Stage Renal Disease|Patients with end stage renal disease, without SIRS or sepsis
85555|NCT02052895|B2|Baseline|Control|Patients without SIRS, sepsis, or end stage renal disease
85556|NCT02052895|B1|Baseline|Sepsis/SIRS|Patients with sepsis or SIRS
85557|NCT02052895|P3|Participant Flow|End Stage Renal Disease|Patients with end stage renal disease, without SIRS or sepsis
85558|NCT02052895|P2|Participant Flow|Control|Patients without SIRS, sepsis, or end stage renal disease
85559|NCT02052895|P1|Participant Flow|Sepsis/SIRS|Patients with sepsis or SIRS
85560|NCT02052895|O2|Outcome|Procalcitonin|ROC-AUC of procalcitonin for discriminating between Sepsis and SIRS
85561|NCT02052895|O1|Outcome|Presepsin|ROC-AUC of presepsin for discriminating between Sepsis and SIRS
85562|NCT02052895|E3|Reported Event|End Stage Renal Disease|Patients with end stage renal disease, without SIRS or sepsis
85563|NCT02052895|E2|Reported Event|Control|Patients without SIRS, sepsis, or end stage renal disease
85564|NCT02052895|E1|Reported Event|Sepsis/SIRS|Patients with sepsis or SIRS
85565|NCT02052752|B4|Baseline|Total|Total of all reporting groups
85566|NCT02052752|B3|Baseline|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
85567|NCT02052752|B2|Baseline|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
85568|NCT02052752|B1|Baseline|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
85569|NCT02052752|P3|Participant Flow|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
85570|NCT02052752|P2|Participant Flow|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
85571|NCT02052752|P1|Participant Flow|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
85572|NCT02052752|O3|Outcome|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
85573|NCT02052752|O2|Outcome|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
85574|NCT02052752|O1|Outcome|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
85575|NCT02052752|O3|Outcome|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3
85576|NCT02052752|O2|Outcome|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
85577|NCT02052752|O1|Outcome|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
85580|NCT02052752|O1|Outcome|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
85581|NCT02052752|O3|Outcome|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
85582|NCT02052752|O2|Outcome|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
85583|NCT02052752|O1|Outcome|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
85584|NCT02052752|O3|Outcome|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
85585|NCT02052752|O2|Outcome|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
85586|NCT02052752|O1|Outcome|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
85587|NCT02052752|O3|Outcome|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
85588|NCT02052752|O2|Outcome|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
85589|NCT02052752|O1|Outcome|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
85590|NCT02052752|E3|Reported Event|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
85591|NCT02052752|E2|Reported Event|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
85592|NCT02052752|E1|Reported Event|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
85593|NCT02052661|B1|Baseline|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
85594|NCT02052661|P1|Participant Flow|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
85595|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
85596|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
85597|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
85598|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
85599|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
85600|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
85601|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
85602|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
85603|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
85604|NCT02052661|E1|Reported Event|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
85605|NCT02052635|B3|Baseline|Total|Total of all reporting groups
85606|NCT02052635|B2|Baseline|Clopidogrel|A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
85607|NCT02052635|B1|Baseline|Ticagrelor|A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
85608|NCT02052635|P2|Participant Flow|Clopidogrel|A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
85609|NCT02052635|P1|Participant Flow|Ticagrelor|A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
85610|NCT02052635|O2|Outcome|Clopidogrel|A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
85611|NCT02052635|O1|Outcome|Ticagrelor|A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
85612|NCT02052635|O2|Outcome|Clopidogrel|A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
85613|NCT02052635|O1|Outcome|Ticagrelor|A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
85614|NCT02052635|E2|Reported Event|Clopidogrel|A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
85615|NCT02052635|E1|Reported Event|Ticagrelor|A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
85616|NCT02052596|B3|Baseline|Total|Total of all reporting groups
85617|NCT02052596|B2|Baseline|Control Group|Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
85618|NCT02052596|B1|Baseline|GSK1437173A Group|Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.
85619|NCT02052596|P2|Participant Flow|Control Group|Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
85620|NCT02052596|P1|Participant Flow|GSK1437173A Group|Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.
85621|NCT02052596|O2|Outcome|Control Group|Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
85622|NCT02052596|O1|Outcome|GSK1437173A Group|Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.
85623|NCT02052596|O2|Outcome|Control Group|Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
85624|NCT02052596|O1|Outcome|GSK1437173A Group|Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.
85625|NCT02052596|O2|Outcome|Control Group|Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
85626|NCT02052596|O1|Outcome|GSK1437173A Group|Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.
85627|NCT02052596|O2|Outcome|Control Group|Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
85628|NCT02052596|O1|Outcome|GSK1437173A Group|Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.
85629|NCT02052596|O2|Outcome|Control Group|Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
85630|NCT02052596|O1|Outcome|GSK1437173A Group|Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.
85631|NCT02052596|O2|Outcome|Control Group|Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
85632|NCT02052596|O1|Outcome|GSK1437173A Group|Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.
85633|NCT02052596|O2|Outcome|Control Group|Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
85634|NCT02052596|O1|Outcome|GSK1437173A Group|Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.
85635|NCT02052596|O2|Outcome|Control Group|Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
85688|NCT02052011|B2|Baseline|Placebo Control|Subjects will take placebo pill twice daily for 4 weeks.
85636|NCT02052596|O1|Outcome|GSK1437173A Group|Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.
85637|NCT02052596|O2|Outcome|Control Group|Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
85638|NCT02052596|O1|Outcome|GSK1437173A Group|Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.
85639|NCT02052596|O2|Outcome|Control Group|Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
85640|NCT02052596|O1|Outcome|GSK1437173A Group|Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.
85641|NCT02052596|O1|Outcome|GSK1437173A Group|Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.
85642|NCT02052596|E2|Reported Event|Control Group|Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
85643|NCT02052596|E1|Reported Event|GSK1437173A Group|Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.
85644|NCT02052544|B1|Baseline|Plasma Samples From Subjects Receiving Unfractionated Heparin|A total of 123 valid patients were recruited over three clinical centers (two in Europe, one in the US). The patients were selected from subjects receiving UFH therapy and who have given written informed consent. Excluded from the study were subjects treated with any other anticoagulants other than UFH, subjects who have been undergoing fibrinolytic therapy within the previous 4 weeks, subjects known to have a congenital bleeding disorder, subjects known to show coagulation factor deficiencies and subjects known to have a coagulation inhibitor or an unexplained APTT prolongation.
85645|NCT02052544|P1|Participant Flow|Study Patients|Patients receiving unfractionated heparin (UFH)
85646|NCT02052544|O2|Outcome|Hemosil|Sensitivity and Specificity of Hemosil
85647|NCT02052544|O1|Outcome|Pefakit|Sensitivity and Specificity of Pefakit
85648|NCT02052544|E1|Reported Event|Study Patients|Patients receiving unfractionated heparin (UFH)
85649|NCT02052466|B1|Baseline|Reverse TSA Patients|Patients having undergone reverse Total Shoulder Arthroplasty (TSA) at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
85650|NCT02052466|P1|Participant Flow|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
85651|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
85652|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
85653|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
85654|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
85655|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
85656|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
85657|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
85658|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
85659|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
85660|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
85661|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
85662|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
85663|NCT02052466|E1|Reported Event|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
85664|NCT02052440|B3|Baseline|Total|Total of all reporting groups
85665|NCT02052440|B2|Baseline|Sugar Pill Given Three Times Daily|"Placebo sugar bill~Placebo: Sugar pill by mouth three times daily"
85666|NCT02052440|B1|Baseline|Baclofen 10mg Three Times Daily|"Baclofen 10mg by mouth three times daily~Baclofen: Treatment arm: baclofen 10mg tid"
85667|NCT02052440|P2|Participant Flow|Sugar Pill Given Three Times Daily|"Placebo sugar bill~Placebo: Sugar pill by mouth three times daily"
85668|NCT02052440|P1|Participant Flow|Baclofen 10mg Three Times Daily|"Baclofen 10mg by mouth three times daily~Baclofen: Treatment arm: baclofen 10mg tid"
85669|NCT02052440|O2|Outcome|Sugar Pill Given Three Times Daily|"Placebo sugar bill~Placebo: Sugar pill by mouth three times daily"
85670|NCT02052440|O1|Outcome|Baclofen 10mg Three Times Daily|"Baclofen 10mg by mouth three times daily~Baclofen: Treatment arm: baclofen 10mg tid"
85671|NCT02052440|O2|Outcome|Sugar Pill Given Three Times Daily|"Placebo sugar bill~Placebo: Sugar pill by mouth three times daily"
85672|NCT02052440|O1|Outcome|Baclofen 10mg Three Times Daily|"Baclofen 10mg by mouth three times daily~Baclofen: Treatment arm: baclofen 10mg tid"
85673|NCT02052440|O2|Outcome|Sugar Pill Given Three Times Daily|"Placebo sugar bill~Placebo: Sugar pill by mouth three times daily"
85674|NCT02052440|O1|Outcome|Baclofen 10mg Three Times Daily|"Baclofen 10mg by mouth three times daily~Baclofen: Treatment arm: baclofen 10mg tid"
85675|NCT02052440|O2|Outcome|Sugar Pill Given Three Times Daily|"Placebo sugar bill~Placebo: Sugar pill by mouth three times daily"
85676|NCT02052440|O1|Outcome|Baclofen 10mg Three Times Daily|"Baclofen 10mg by mouth three times daily~Baclofen: Treatment arm: baclofen 10mg tid"
85677|NCT02052440|E2|Reported Event|Sugar Pill Given Three Times Daily|"Placebo sugar bill~Placebo: Sugar pill by mouth three times daily"
85678|NCT02052440|E1|Reported Event|Baclofen 10mg Three Times Daily|"Baclofen 10mg by mouth three times daily~Baclofen: Treatment arm: baclofen 10mg tid"
85679|NCT02052414|B1|Baseline|Gralise (Gabapentin ER)|"This is an open label trial to evaluate the efficacy of Gralise against fibromyalgia pain. If subject is taking gabapentinoids at the time of enrollment, subjects will be required to wash off the medication; otherwise they can start the starter pack for Gralise, and will eventually up titrated to treatment dose of 1800mg with evening meals per day.~Subjects will be followed every 4 weeks for total of 12 weeks. At the end of 12 weeks, subjects will be wash off the Gralise over 2 weeks, and will have a final end of treatment visit at week 15.~Subjects will be asked to rate their pain on numeric pain rating system (NPRS) as primary outcome measure. Subjects will be asked to assess Fibromyalgia Impact Questionnaire (FIQ), Medical Outcome Study (MOS) Sleep questionnaire, and Patient Global Impression of Change (PGIC) as secondary outcome measures.~At each follow up visits, occurrence of adverse events, and changes to concomitant medications were evaluated and recorded."
85680|NCT02052414|P1|Participant Flow|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.~All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.~Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.~Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
85681|NCT02052414|O1|Outcome|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.~All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.~Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.~Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
85682|NCT02052414|O1|Outcome|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.~All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.~Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.~Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
85683|NCT02052414|O1|Outcome|Gralise (Gabapentin ER)|All subjects were assessed for occurrence of adverse events at follow up visits. All reported adverse events were tabulated, and presented in this study.
85684|NCT02052414|O1|Outcome|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.~All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.~Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.~Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
85685|NCT02052414|O1|Outcome|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.~All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.~Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.~Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
85686|NCT02052414|E1|Reported Event|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.~All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.~Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.~Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
85687|NCT02052011|B3|Baseline|Total|Total of all reporting groups
85689|NCT02052011|B1|Baseline|Intervention Group|Subjects will take extended release Ranolazine for 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin).
85690|NCT02052011|P2|Participant Flow|Placebo Control|Subjects will take placebo pill twice daily for 4 weeks.
85691|NCT02052011|P1|Participant Flow|Intervention Group|Subjects will take extended release Ranolazine for 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin).
85692|NCT02052011|O2|Outcome|Placebo Control|Subjects will take placebo pill twice daily for 4 weeks.
85693|NCT02052011|O1|Outcome|Intervention Group|Subjects will take extended release Ranolazine for 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin).
85694|NCT02052011|E2|Reported Event|Placebo Control|Subjects will take placebo pill twice daily for 4 weeks.
85695|NCT02052011|E1|Reported Event|Intervention Group|Subjects will take extended release Ranolazine for 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin).
85696|NCT02051816|B5|Baseline|Total|Total of all reporting groups
85697|NCT02051816|B4|Baseline|Direct Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~and~No apneic oxygenation"
85698|NCT02051816|B3|Baseline|Video Laryngoscopy and no Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~and~No apneic oxygenation"
85699|NCT02051816|B2|Baseline|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~and~A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure"
85700|NCT02051816|B1|Baseline|Video Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~and~A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure"
85701|NCT02051816|P4|Participant Flow|Direct Laryngoscopy and No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.~Direct Laryngoscopy"
85702|NCT02051816|P3|Participant Flow|Video Laryngoscopy and Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure~Video Laryngoscopy"
85703|NCT02051816|P2|Participant Flow|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~Apneic Oxygenation"
85704|NCT02051816|P1|Participant Flow|Video Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~No Apneic Oxygenation"
85705|NCT02051816|O4|Outcome|Direct Laryngoscopy and No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.~Direct Laryngoscopy"
85706|NCT02051816|O3|Outcome|Video Laryngoscopy and Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure~Video Laryngoscopy"
85707|NCT02051816|O2|Outcome|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~Apneic Oxygenation"
85708|NCT02051816|O1|Outcome|Video Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~No Apneic Oxygenation"
85709|NCT02051816|O4|Outcome|Direct Laryngoscopy and No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.~Direct Laryngoscopy"
85710|NCT02051816|O3|Outcome|Video Laryngoscopy and Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure~Video Laryngoscopy"
85711|NCT02051816|O2|Outcome|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~Apneic Oxygenation"
85712|NCT02051816|O1|Outcome|Video Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~No Apneic Oxygenation"
85713|NCT02051816|O4|Outcome|Direct Laryngoscopy and No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.~Direct Laryngoscopy"
85714|NCT02051816|O3|Outcome|Video Laryngoscopy and Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure~Video Laryngoscopy"
85715|NCT02051816|O2|Outcome|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~Apneic Oxygenation"
85716|NCT02051816|O1|Outcome|Video Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~No Apneic Oxygenation"
85717|NCT02051816|O4|Outcome|Direct Laryngoscopy and No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.~Direct Laryngoscopy"
85718|NCT02051816|O3|Outcome|Video Laryngoscopy and Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure~Video Laryngoscopy"
85719|NCT02051816|O2|Outcome|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~Apneic Oxygenation"
85720|NCT02051816|O1|Outcome|Video Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~No Apneic Oxygenation"
85721|NCT02051816|O4|Outcome|Direct Laryngoscopy and No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.~Direct Laryngoscopy"
85722|NCT02051816|O3|Outcome|Video Laryngoscopy and Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure~Video Laryngoscopy"
85723|NCT02051816|O2|Outcome|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~Apneic Oxygenation"
85724|NCT02051816|O1|Outcome|Video Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~No Apneic Oxygenation"
85725|NCT02051816|O4|Outcome|Direct Laryngoscopy and No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.~Direct Laryngoscopy"
85726|NCT02051816|O3|Outcome|Video Laryngoscopy and Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure~Video Laryngoscopy"
85727|NCT02051816|O2|Outcome|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~Apneic Oxygenation"
85728|NCT02051816|O1|Outcome|Video Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~No Apneic Oxygenation"
85729|NCT02051816|O4|Outcome|No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.~Video Laryngoscopy~Direct Laryngoscopy"
85730|NCT02051816|O3|Outcome|Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure~Video Laryngoscopy~Direct Laryngoscopy"
85731|NCT02051816|O2|Outcome|Direct Laryngoscopy|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~Apneic Oxygenation~No Apneic Oxygenation"
85732|NCT02051816|O1|Outcome|Video Laryngoscopy|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~Apneic Oxygenation~No Apneic Oxygenation"
85733|NCT02051816|O4|Outcome|No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.~Video Laryngoscopy~Direct Laryngoscopy"
85734|NCT02051816|O3|Outcome|Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure~Video Laryngoscopy~Direct Laryngoscopy"
85735|NCT02051816|O2|Outcome|Direct Laryngoscopy|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~Apneic Oxygenation~No Apneic Oxygenation"
85736|NCT02051816|O1|Outcome|Video Laryngoscopy|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~Apneic Oxygenation~No Apneic Oxygenation"
85737|NCT02051816|E4|Reported Event|No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.~Video Laryngoscopy~Direct Laryngoscopy"
85738|NCT02051816|E3|Reported Event|Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure~Video Laryngoscopy~Direct Laryngoscopy"
85739|NCT02051816|E2|Reported Event|Direct Laryngoscopy|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~Apneic Oxygenation~No Apneic Oxygenation"
85740|NCT02051816|E1|Reported Event|Video Laryngoscopy|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~Apneic Oxygenation~No Apneic Oxygenation"
85741|NCT02051790|B1|Baseline|Clinical Practice Scans|"241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans.~florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice."
85742|NCT02051790|P1|Participant Flow|Clinical Practice Scans|"241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans.~florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice."
85743|NCT02051790|O1|Outcome|Clinical Practice Scans|"241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans.~florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice."
85744|NCT02051790|E1|Reported Event|Clinical Practice Scans|"241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans.~florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice."
85745|NCT02051686|B3|Baseline|Total|Total of all reporting groups
85747|NCT02051686|B1|Baseline|Tranexamic Acid|Patients in the intervention group were administered a 10mg/kg preoperative dose of tranexamic acid within 30 minutes prior to surgery followed by a 10mg/kg infusion over a 4hr period during surgery.
85748|NCT02051686|P2|Participant Flow|Placebo|"The control group will receive a similar volume load of normal saline and maintenance doses.~Placebo: The control group will receive a similar volume load of normal saline and maintenance doses."
85749|NCT02051686|P1|Participant Flow|Tranexamic Acid|"Group I will receive 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.~Tranexamic Acid: 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours."
85750|NCT02051686|O2|Outcome|Placebo|"The control group will receive a similar volume load of normal saline and maintenance doses.~Placebo: The control group will receive a similar volume load of normal saline and maintenance doses."
85751|NCT02051686|O1|Outcome|Tranexamic Acid|"Group I will receive 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.~Tranexamic Acid: 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours."
85752|NCT02051686|O2|Outcome|Placebo|"The control group will receive a similar volume load of normal saline and maintenance doses.~Placebo: The control group will receive a similar volume load of normal saline and maintenance doses."
85753|NCT02051686|O1|Outcome|Tranexamic Acid|"Group I will receive 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.~Tranexamic Acid: 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours."
85754|NCT02051686|E2|Reported Event|Placebo|"The control group will receive a similar volume load of normal saline and maintenance doses.~Placebo: The control group will receive a similar volume load of normal saline and maintenance doses."
85755|NCT02051686|E1|Reported Event|Tranexamic Acid|"Group I will receive 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.~Tranexamic Acid: 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours."
85756|NCT02051595|B1|Baseline|Vancomycin Concentrations|"Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.~Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration."
85757|NCT02051595|P1|Participant Flow|Vancomycin Concentrations|"Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.~Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration."
85758|NCT02051595|O1|Outcome|Vancomycin Concentrations|"Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.~Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration."
85759|NCT02051595|E1|Reported Event|Vancomycin Concentrations|"Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.~Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration."
85760|NCT02051426|B3|Baseline|Total|Total of all reporting groups
85761|NCT02051426|B2|Baseline|Placebo First, Then D-serine|corn starch, then D-serine (2.1g)
85762|NCT02051426|B1|Baseline|D-serine First, Then Placebo|D-serine (2.1g), then placebo (corn starch)
85763|NCT02051426|P2|Participant Flow|Placebo First, Then D-serine|corn starch, then D-serine (2.1g)
85764|NCT02051426|P1|Participant Flow|D-serine First, Then Placebo|D-serine (2.1g), then Placebo (corn starch)
85765|NCT02051426|O2|Outcome|Placebo|corn starch
85766|NCT02051426|O1|Outcome|D-serine|D-serine (2.1g)
85767|NCT02051426|O2|Outcome|Placebo|corn starch
85768|NCT02051426|O1|Outcome|D-serine|D-serine (2.1g)
85769|NCT02051426|O2|Outcome|Placebo|corn starch
85770|NCT02051426|O1|Outcome|D-serine|D-serine (2.1g)
85771|NCT02051426|E2|Reported Event|Placebo|corn starch
85772|NCT02051426|E1|Reported Event|D-serine|D-serine (2.1g)
85773|NCT02051335|B5|Baseline|Total|Total of all reporting groups
85774|NCT02051335|B4|Baseline|Sequence 4 (DACB)|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
85775|NCT02051335|B3|Baseline|Sequence 3 (CDBA)|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
85793|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85794|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85776|NCT02051335|B2|Baseline|Sequence 2 (BCAD)|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
85777|NCT02051335|B1|Baseline|Sequence 1 (ABDC)|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
85778|NCT02051335|P4|Participant Flow|Sequence 4 (DACB)|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
85779|NCT02051335|P3|Participant Flow|Sequence 3 (CDBA)|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
85780|NCT02051335|P2|Participant Flow|Sequence 2 (BCAD)|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
85781|NCT02051335|P1|Participant Flow|Sequence 1 (ABDC)|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
85782|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85783|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85784|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85785|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85786|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85787|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85788|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85789|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85790|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85791|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85792|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85795|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85796|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85797|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85798|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85799|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85800|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85801|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85802|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85803|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85804|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85805|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85806|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85807|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85808|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85809|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85810|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85811|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85812|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85813|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85814|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85815|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85816|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85817|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85818|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85819|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85820|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85821|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85822|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85823|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85824|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85825|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85826|NCT02051335|E4|Reported Event|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85827|NCT02051335|E3|Reported Event|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85828|NCT02051335|E2|Reported Event|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85829|NCT02051335|E1|Reported Event|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
85830|NCT02050334|B3|Baseline|Total|Total of all reporting groups
85831|NCT02050334|B2|Baseline|CC100 (2 Single Doses) & Placebo(1 Dose)|"CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100~Placebo"
85832|NCT02050334|B1|Baseline|CC100 (3 Single Doses)|"CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100"
85833|NCT02050334|P2|Participant Flow|CC100 (2 Single Doses) & Placebo(1 Dose)|"CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100~Placebo"
85834|NCT02050334|P1|Participant Flow|CC100 (3 Single Doses)|"CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100"
85835|NCT02050334|O1|Outcome|CC100 Single Doses|CC100: 2, 5, 10, and 20 mg/kg doses.
85836|NCT02050334|O1|Outcome|CC100 Single Doses|CC100: 2, 5, 10, and 20 mg/kg doses.
85837|NCT02050334|O2|Outcome|CC100 (2 Single Doses) & Placebo(1 Dose)|"CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100~Placebo"
85838|NCT02050334|O1|Outcome|CC100 (3 Single Doses)|"CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100"
85839|NCT02050334|E2|Reported Event|CC100 (2 Single Doses) & Placebo(1 Dose)|"CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100~Placebo"
85840|NCT02050334|E1|Reported Event|CC100 (3 Single Doses)|"CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100"
85841|NCT02050321|B1|Baseline|Acitretin and Vemurafenib|"Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose.~Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months~Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months"
85842|NCT02050321|P1|Participant Flow|Acitretin and Vemurafenib|"Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose.~Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months~Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months"
85843|NCT02050321|O1|Outcome|Acitretin and Vemurafenib|"Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose.~Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months~Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months"
85844|NCT02050321|O1|Outcome|Acitretin and Vemurafenib|"Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose.~Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months~Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months"
85845|NCT02050321|E1|Reported Event|Acitretin and Vemurafenib|"Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose.~Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months~Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months"
85846|NCT02050048|B3|Baseline|Total|Total of all reporting groups
85847|NCT02050048|B2|Baseline|Low Volume Group (Control Arm)|In the low volume group (control arm), patients will receive intravenous Lactated Ringer's solution at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluids may be continued through the 90 minute post-procedure observation period.
85848|NCT02050048|B1|Baseline|High Volume Group (Intervention Arm)|"Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:~initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour~LR fluid infusion during the procedure at 5 cc/kg/hr~Post-procedure bolus of 20 cc/kg over 90 minutes"
85849|NCT02050048|P2|Participant Flow|Low Volume Group (Control Arm)|In the low volume group (control arm), patients will receive fluids at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluids may be continued through the 90 minute post-procedure observation period.
85850|NCT02050048|P1|Participant Flow|High Volume Group (Intervention Arm)|"Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:~initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour~LR fluid infusion during the procedure at 5 cc/kg/hr~Post-procedure bolus of 20 cc/kg over 90 minutes"
85851|NCT02050048|O2|Outcome|Low Volume Group (Control Arm)|Patients will be randomized to receive intravenous Lactated Ringer's solution. In the low volume group (control arm), patients will receive fluids at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluid administration may be continued through the 90 minute post-procedure observation period.
85852|NCT02050048|O1|Outcome|High Volume Group (Intervention Arm)|"Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:~initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour~LR fluid infusion during the procedure at 5 cc/kg/hr~Post-procedure bolus of 20 cc/kg over 90 minutes"
85853|NCT02050048|E2|Reported Event|Low Volume Group (Control Arm)|Patients will be randomized to receive intravenous Lactated Ringer's solution. In the low volume group (control arm), patients will receive fluids at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluids may be continued through the 90 minute post-procedure observation period.
85854|NCT02050048|E1|Reported Event|High Volume Group (Intervention Arm)|"Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:~initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour~LR fluid infusion during the procedure at 5 cc/kg/hr~Post-procedure bolus of 20 cc/kg over 90 minutes"
85855|NCT02049931|B4|Baseline|Total|Total of all reporting groups
85856|NCT02049931|B3|Baseline|Soft Brace Group|"Because soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.~Soft brace: In soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks. Then, weaning period requires additional 4 weeks."
85857|NCT02049931|B2|Baseline|Rigid Brace Group|"Patients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.~Rigid brace: In rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks. Then, weaning period requires additional 4 weeks."
85858|NCT02049931|B1|Baseline|No Brace Group|"Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.~No brace treatment: Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable."
85859|NCT02049931|P3|Participant Flow|Soft Brace Group|"Because soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.~Soft brace: In soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks."
85860|NCT02049931|P2|Participant Flow|Rigid Brace Group|"Patients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.~Rigid brace: In rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks."
85861|NCT02049931|P1|Participant Flow|No Brace Group|"Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.~No brace treatment: Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable."
85862|NCT02049931|O3|Outcome|Soft Brace Group|"Because soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.~Soft brace: In soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks."
85863|NCT02049931|O2|Outcome|Rigid Brace Group|"Patients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.~Rigid brace: In rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks."
85864|NCT02049931|O1|Outcome|No Brace Group|"Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.~No brace treatment: Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable."
85865|NCT02049931|E3|Reported Event|Soft Brace Group|"Because soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.~Soft brace: In soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks."
85866|NCT02049931|E2|Reported Event|Rigid Brace Group|"Patients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.~Rigid brace: In rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks."
85867|NCT02049931|E1|Reported Event|No Brace Group|"Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.~No brace treatment: Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable."
85868|NCT02049450|B1|Baseline|INC424 (Ruxolitinib) - Study Treatment|Regularly transfused adult patients with thalassemia and spleen enlargement
85869|NCT02049450|P1|Participant Flow|INC424 (Ruxolitinib) - Study Treatment|Regularly transfused adult patients with thalassemia and spleen enlargement
85870|NCT02049450|O4|Outcome|20mg Bid|Patients who received INC422 20mg bid
85871|NCT02049450|O3|Outcome|15mg Bid|Patients who received INC422 15mg bid
85872|NCT02049450|O2|Outcome|10mg Bid|Patients who received INC422 10mg bid
85873|NCT02049450|O1|Outcome|5mg Bid|Patients who received INC422 5mg bid
85874|NCT02049450|O3|Outcome|20mg Bid|Patients who received INC422 20mg bid
85875|NCT02049450|O2|Outcome|15mg Bid|Patients who received INC422 15mg bid
85876|NCT02049450|O1|Outcome|10 mg Bid|Patients who received INC422 10mg bid
85877|NCT02049450|O1|Outcome|INC424 (Ruxolitinib) - Study Treatment|Regularly transfused adult patients with thalassemia and spleen enlargement
85878|NCT02049450|O1|Outcome|INC424 (Ruxolitinib) - Study Treatment|Regularly transfused adult patients with thalassemia and spleen enlargement
85879|NCT02049450|O1|Outcome|INC424 (Ruxolitinib) - Study Treatment|Regularly transfused adult patients with thalassemia and spleen enlargement
85880|NCT02049450|O1|Outcome|INC424 (Ruxolitinib) - Study Treatment|Regularly transfused adult patients with thalassemia and spleen enlargement
85881|NCT02049450|E1|Reported Event|INC424 (Ruxolitinib) - Study Treatment|Regularly transfused adult patients with thalassemia and spleen enlargement
85882|NCT02049385|B1|Baseline|All Participants|Subjects received 200-400 mg daily of diazoxide orally for three weeks; the dose was, adjusted depending on side effects and response.
85883|NCT02049385|P2|Participant Flow|Placebo, Then Diazoxide|Subjects received a matched placebo for three weeks.
85884|NCT02049385|P1|Participant Flow|Diazoxide, Then Placebo|Subjects received 200-400 mg daily of diazoxide orally for three weeks; the dose was adjusted depending on side effects and response.
85885|NCT02049385|O2|Outcome|Placebo|Subjects received a matched placebo for three weeks.
85886|NCT02049385|O1|Outcome|Diazoxide|Subjects received 200-400 mg daily of diazoxide orally for three weeks; the dose was adjusted depending on side effects and response.
85887|NCT02049385|E2|Reported Event|Placebo|Subjects received a matched placebo for three weeks.
85888|NCT02049385|E1|Reported Event|Diazoxide|Subjects received 200-400 mg daily of diazoxide orally for three weeks; the dose was adjusted depending on side effects and response.
85889|NCT02049151|B3|Baseline|Total Title|
85890|NCT02049151|B2|Baseline|Placebo + Saline|Single dose of saline (sodium chloride, 9 g/L) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
85891|NCT02049151|B1|Baseline|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 mcg) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.
85892|NCT02049151|P2|Participant Flow|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
85893|NCT02049151|P1|Participant Flow|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 micrograms [mcg]) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.
85894|NCT02049151|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 g/L) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
85895|NCT02049151|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 mcg) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.
85969|NCT02046993|O2|Outcome|Hypertensive Patients on Enhanced Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
85896|NCT02049151|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 g/L) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
85897|NCT02049151|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 mcg) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.
85898|NCT02049151|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 g/L) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
85899|NCT02049151|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 mcg) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.
85900|NCT02049151|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 g/L) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
85901|NCT02049151|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 mcg) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.
85902|NCT02049151|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 g/L) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
85903|NCT02049151|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 mcg) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.
85904|NCT02049151|E2|Reported Event|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
85905|NCT02049151|E1|Reported Event|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 micrograms [mcg]) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented
85906|NCT02048904|B1|Baseline|Sitagliptin or Placebo|"100 mg/day for 3 months or 1 pill/day for 3 months~Sitagliptin: Sitagliptin 100 mg/day for 3 months or Placebo: Placebo 1 pill/day for 3 months"
85907|NCT02048904|P1|Participant Flow|Sitagliptin or Placebo|"100 mg/day for 3 months or 1 pill/day for 3 months~Sitagliptin: Sitagliptin 100 mg/day for 3 months or Placebo: Placebo 1 pill/day for 3 months"
85908|NCT02048904|O1|Outcome|Sitagliptin or Placebo|"100 mg/day for 3 months or 1 pill/day for 3 months~Sitagliptin: Sitagliptin 100 mg/day for 3 months or Placebo: Placebo 1 pill/day for 3 months"
85909|NCT02048904|E1|Reported Event|Sitagliptin or Placebo|"100 mg/day for 3 months or 1 pill/day for 3 months~Sitagliptin: Sitagliptin 100 mg/day for 3 months or Placebo: Placebo 1 pill/day for 3 months"
85910|NCT02048891|B3|Baseline|Total|Total of all reporting groups
85911|NCT02048891|B2|Baseline|GnRH Agonist Trigger|"ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.~GnRH agonist trigger"
85912|NCT02048891|B1|Baseline|hCG Trigger|"Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.~hCG trigger"
85913|NCT02048891|P2|Participant Flow|GnRH Agonist Trigger|"ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.~GnRH agonist trigger"
85914|NCT02048891|P1|Participant Flow|hCG Trigger|"Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.~hCG trigger"
85915|NCT02048891|O2|Outcome|GnRH Agonist Trigger|"ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.~GnRH agonist trigger"
85916|NCT02048891|O1|Outcome|hCG Trigger|"Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.~hCG trigger"
85917|NCT02048891|E2|Reported Event|GnRH Agonist Trigger|"ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.~GnRH agonist trigger"
85918|NCT02048891|E1|Reported Event|hCG Trigger|"Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.~hCG trigger"
85919|NCT02048241|B3|Baseline|Total|Total of all reporting groups
86038|NCT02046564|O2|Outcome|Placebo|The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
87469|NCT02039414|O2|Outcome|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
85920|NCT02048241|B2|Baseline|Intuniv Plus Parent Management Training|"Administration of Intuniv in increasing doses from 1 mg to 2 mgs to 3 mgs to 4 mgs as tolerated over a period of 4-6 weeks, combined with weekly Parent Management Training~Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.~Intuniv: Weekly administration of medication in doses as per protocol"
85921|NCT02048241|B1|Baseline|Placebo Plus Parent Management Training|"Pills matching Intuniv Tablets without active medication combined with weekly Parent Management Training~Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.~Placebo: Weekly dispensation of pills matching Intuniv but without the active medication"
85922|NCT02048241|P2|Participant Flow|Intuniv Plus Parent Management Training|"Administration of Intuniv in increasing doses from 1 mg to 2 mgs to 3 mgs to 4 mgs as tolerated over a period of 4-6 weeks, combined with weekly Parent Management Training~Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.~Intuniv: Weekly administration of medication in doses as per protocol"
85923|NCT02048241|P1|Participant Flow|Placebo Plus Parent Management Training|"Pills matching Intuniv Tablets without active medication combined with weekly Parent Management Training~Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.~Placebo: Weekly dispensation of pills matching Intuniv but without the active medication"
85924|NCT02048241|O2|Outcome|Intuniv Plus Parent Management Training|"Administration of Intuniv in increasing doses from 1 mg to 2 mgs to 3 mgs to 4 mgs as tolerated over a period of 4-6 weeks, combined with weekly Parent Management Training~Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.~Intuniv: Weekly administration of medication in doses as per protocol"
85925|NCT02048241|O1|Outcome|Placebo Plus Parent Management Training|"Pills matching Intuniv Tablets without active medication combined with weekly Parent Management Training~Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.~Placebo: Weekly dispensation of pills matching Intuniv but without the active medication"
85926|NCT02048241|E2|Reported Event|Intuniv Plus Parent Management Training|"Administration of Intuniv in increasing doses from 1 mg to 2 mgs to 3 mgs to 4 mgs as tolerated over a period of 4-6 weeks, combined with weekly Parent Management Training~Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.~Intuniv: Weekly administration of medication in doses as per protocol"
85927|NCT02048241|E1|Reported Event|Placebo Plus Parent Management Training|"Pills matching Intuniv Tablets without active medication combined with weekly Parent Management Training~Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.~Placebo: Weekly dispensation of pills matching Intuniv but without the active medication"
85928|NCT02048072|B1|Baseline|Gilenya|Gilenya 0.5mg p.o. once daily
85929|NCT02048072|P1|Participant Flow|Gilenya|Gilenya 0.5mg p.o. once daily
85930|NCT02048072|O1|Outcome|Gilenya|Gilenya 0.5mg p.o. once daily
85931|NCT02048072|E1|Reported Event|Gilenya|Gilenya 0.5mg p.o. once daily
85932|NCT02047747|B1|Baseline|Dacomitinib|"Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.~Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days."
85933|NCT02047747|P1|Participant Flow|Dacomitinib|"Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.~Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days."
85934|NCT02047747|O1|Outcome|Dacomitinib|"Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.~Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days."
85935|NCT02047747|O1|Outcome|Dacomitinib|"Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.~Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days."
85936|NCT02047747|E1|Reported Event|Dacomitinib|"Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.~Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days."
85937|NCT02047500|B1|Baseline|TH-302 Plus Nab-paclitaxel Plus Gemcitabine|"TH-302: TH-302 will be administered at a dose ranging from 170-340 milligram per square meter (mg/m^2) as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Nab-paclitaxel: Nab-paclitaxel will be administered at a dose ranging from 100-125 mg/m^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Gemcitabine: Gemcitabine will be administered at a dose ranging from 800-1000 mg/m^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal."
85938|NCT02047500|P1|Participant Flow|TH-302 Plus Nab-paclitaxel Plus Gemcitabine|"TH-302: TH-302 will be administered at a dose ranging from 170-340 milligram per square meter (mg/m^2) as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Nab-paclitaxel: Nab-paclitaxel will be administered at a dose ranging from 100-125 mg/m^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Gemcitabine: Gemcitabine will be administered at a dose ranging from 800-1000 mg/m^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal."
86082|NCT02046369|O2|Outcome|Placebo|"Placebo administered once daily~Placebo: Placebo Comparator once daily"
85939|NCT02047500|O1|Outcome|TH-302 Plus Nab-paclitaxel Plus Gemcitabine|"TH-302: TH-302 will be administered at a dose ranging from 170-340 milligram per square meter (mg/m^2) as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Nab-paclitaxel: Nab-paclitaxel will be administered at a dose ranging from 100-125 mg/m^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Gemcitabine: Gemcitabine will be administered at a dose ranging from 800-1000 mg/m^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal."
85940|NCT02047500|E1|Reported Event|TH-302 Plus Nab-paclitaxel Plus Gemcitabine|"TH-302: TH-302 will be administered at a dose ranging from 170-340 milligram per square meter (mg/m^2) as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Nab-paclitaxel: Nab-paclitaxel will be administered at a dose ranging from 100-125 mg/m^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Gemcitabine: Gemcitabine will be administered at a dose ranging from 800-1000 mg/m^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal."
85941|NCT02047227|B3|Baseline|Total|Total of all reporting groups
85942|NCT02047227|B2|Baseline|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
85943|NCT02047227|B1|Baseline|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
85944|NCT02047227|P2|Participant Flow|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
85945|NCT02047227|P1|Participant Flow|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 International Unit (IU) recombinant human follicular stimulating hormone (rhFSH)/ 150 IU recombinant human luteinizing hormone (rhLH) after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 millimeter (mm); 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) (Ovidrel) was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
85946|NCT02047227|O2|Outcome|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
85947|NCT02047227|O1|Outcome|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
85948|NCT02047227|O2|Outcome|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
85949|NCT02047227|O1|Outcome|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
85950|NCT02047227|O2|Outcome|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
85951|NCT02047227|O1|Outcome|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
86083|NCT02046369|O1|Outcome|Luradisone|"Luradisone 20- 80 mg administered once daily~Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily"
85952|NCT02047227|O2|Outcome|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
85953|NCT02047227|O1|Outcome|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
85954|NCT02047227|O2|Outcome|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
85955|NCT02047227|O1|Outcome|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
85956|NCT02047227|O2|Outcome|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
85957|NCT02047227|O1|Outcome|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
85958|NCT02047227|E2|Reported Event|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
85959|NCT02047227|E1|Reported Event|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
85960|NCT02046993|B3|Baseline|Total|Total of all reporting groups
85961|NCT02046993|B2|Baseline|Hypertensive Patients on Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
85962|NCT02046993|B1|Baseline|Smart Phone Based Telemonitoring of HBP|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
85963|NCT02046993|P2|Participant Flow|Hypertensive Patients on Enahnced Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
85964|NCT02046993|P1|Participant Flow|Smart Phone Based Telemonitoring of HBP + Enhanced Usual Care|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
85965|NCT02046993|O2|Outcome|Hypertensive Patients on Enhanced Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
85966|NCT02046993|O1|Outcome|Smart Phone Based Telemonitoring of HBP|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
85967|NCT02046993|O2|Outcome|Hypertensive Patients on Enhanced Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
85968|NCT02046993|O1|Outcome|Smart Phone Based Telemonitoring of HBP|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
87470|NCT02039414|O1|Outcome|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
85970|NCT02046993|O1|Outcome|Smart Phone Based Telemonitoring of HBP|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
85971|NCT02046993|O2|Outcome|Hypertensive Patients on Enahnced Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
85972|NCT02046993|O1|Outcome|Smart Phone Based Telemonitoring of HBP + Enhanced Usual Care|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
85973|NCT02046993|O2|Outcome|Hypertensive Patients on Enhanced Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
85974|NCT02046993|O1|Outcome|Smart Phone Based Telemonitoring of HBP|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
85975|NCT02046993|O2|Outcome|Hypertensive Patients on Enhanced Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
85976|NCT02046993|O1|Outcome|Smart Phone Based Telemonitoring of HBP|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
85977|NCT02046993|E2|Reported Event|Enhanced Usual Care|". Patients to do HBP measurement~. Record BP readings in their diary~Enhanced usual care: Encouraged to do HBP measurement and record BP readings in paper diary"
85978|NCT02046993|E1|Reported Event|Smart Phone Based Telemonitoring of HBP|". Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP + enhanced usual care: Smart phone telemonitoring home Blood pressure (HBP) Patients input their HBP readings to their smart phone which is sent to the data center regulary"
85979|NCT02046980|B4|Baseline|Total|Total of all reporting groups
85980|NCT02046980|B3|Baseline|Sham|"Sham maneuver for apogeotropic horizontal BPPV at the first day~Sham"
85981|NCT02046980|B2|Baseline|Vibration|"Vibration maneuver for apogeotropic horizontal BPPV at the first day~Vibration"
85982|NCT02046980|B1|Baseline|Gufoni|"Gufoni maneuver for apogeotropic horizontal BPPV at the first day~Gufoni"
85983|NCT02046980|P3|Participant Flow|Sham|"Sham maneuver for apogeotropic horizontal BPPV at the first day~Sham"
85984|NCT02046980|P2|Participant Flow|Vibration|"Vibration maneuver for apogeotropic horizontal BPPV at the first day~Vibration"
85985|NCT02046980|P1|Participant Flow|Gufoni|"Gufoni maneuver for apogeotropic horizontal benign paroxysmal positional vertigo (BPPV) at the first day~Gufoni"
85986|NCT02046980|O3|Outcome|Sham|"Sham maneuver for apogeotropic horizontal BPPV at the first day~Sham"
85987|NCT02046980|O2|Outcome|Vibration|"Vibration maneuver for apogeotropic horizontal BPPV at the first day~Vibration"
85988|NCT02046980|O1|Outcome|Gufoni|"Gufoni maneuver for apogeotropic horizontal BPPV at the first day~Gufoni"
85989|NCT02046980|E3|Reported Event|Sham|"Sham maneuver for apogeotropic horizontal BPPV at the first day~Sham"
85990|NCT02046980|E2|Reported Event|Vibration|"Vibration maneuver for apogeotropic horizontal BPPV at the first day~Vibration"
85991|NCT02046980|E1|Reported Event|Gufoni|"Gufoni maneuver for apogeotropic horizontal BPPV at the first day~Gufoni"
85992|NCT02046863|B1|Baseline|Automated Programming|"Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting.~Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming."
85993|NCT02046863|P1|Participant Flow|Automated Programming|"Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting.~Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming."
85994|NCT02046863|O1|Outcome|Automated Programming|"Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting.~Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming."
85995|NCT02046863|E1|Reported Event|Automated Programming|"Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting.~Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming."
85996|NCT02046772|B3|Baseline|Total|Total of all reporting groups
85997|NCT02046772|B2|Baseline|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
85998|NCT02046772|B1|Baseline|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
85999|NCT02046772|P2|Participant Flow|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
86084|NCT02046369|O2|Outcome|Placebo|"Placebo administered once daily~Placebo: Placebo Comparator once daily"
86000|NCT02046772|P1|Participant Flow|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
86001|NCT02046772|O2|Outcome|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
86002|NCT02046772|O1|Outcome|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
86003|NCT02046772|O2|Outcome|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
86004|NCT02046772|O1|Outcome|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
86005|NCT02046772|O2|Outcome|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
86006|NCT02046772|O1|Outcome|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
86007|NCT02046772|O2|Outcome|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
86008|NCT02046772|O1|Outcome|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
86009|NCT02046772|O2|Outcome|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
86010|NCT02046772|O1|Outcome|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
86011|NCT02046772|E2|Reported Event|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
86012|NCT02046772|E1|Reported Event|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
86013|NCT02046616|B1|Baseline|Tocilizumab Alone or Combined With Methotrexate or Other DMARD|All participants received tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs at a dose of 162 mg, irrespective of body weight, administered subcutaneously QW for 24 weeks. An additional 8 weeks were allotted for post-treatment evaluation of safety/immunogenicity.
86014|NCT02046616|P1|Participant Flow|Tocilizumab Alone or Combined With Methotrexate or Other DMARD|All participants received tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs at a dose of 162 milligrams (mg), irrespective of body weight, administered subcutaneously weekly (QW) for 24 weeks. An additional 8 weeks were allotted for post-treatment evaluation of safety/immunogenicity.
86015|NCT02046616|O1|Outcome|Tocilizumab Alone or Combined With Methotrexate or Other DMARD|All participants received tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs at a dose of 162 mg, irrespective of body weight, administered subcutaneously QW for 24 weeks. An additional 8 weeks were allotted for post-treatment evaluation of safety/immunogenicity.
86016|NCT02046616|O1|Outcome|Tocilizumab Alone or Combined With Methotrexate or Other DMARD|All participants received tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs at a dose of 162 mg, irrespective of body weight, administered subcutaneously QW for 24 weeks. An additional 8 weeks were allotted for post-treatment evaluation of safety/immunogenicity.
86017|NCT02046616|O1|Outcome|Tocilizumab Alone or Combined With Methotrexate or Other DMARD|All participants received tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs at a dose of 162 mg, irrespective of body weight, administered subcutaneously QW for 24 weeks. An additional 8 weeks were allotted for post-treatment evaluation of safety/immunogenicity.
86018|NCT02046616|O1|Outcome|Tocilizumab Alone or Combined With Methotrexate or Other DMARD|All participants received tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs at a dose of 162 mg, irrespective of body weight, administered subcutaneously QW for 24 weeks. An additional 8 weeks were allotted for post-treatment evaluation of safety/immunogenicity.
86085|NCT02046369|O1|Outcome|Luradisone|"Luradisone 20- 80 mg administered once daily~Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily"
86019|NCT02046616|O1|Outcome|Tocilizumab Alone or Combined With Methotrexate or Other DMARD|All participants received tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs at a dose of 162 mg, irrespective of body weight, administered subcutaneously QW for 24 weeks. An additional 8 weeks were allotted for post-treatment evaluation of safety/immunogenicity.
86020|NCT02046616|O1|Outcome|Tocilizumab Alone or Combined With Methotrexate or Other DMARD|All participants received tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs at a dose of 162 mg, irrespective of body weight, administered subcutaneously QW for 24 weeks. An additional 8 weeks were allotted for post-treatment evaluation of safety/immunogenicity.
86021|NCT02046616|O1|Outcome|Tocilizumab Alone or Combined With Methotrexate or Other DMARD|All participants received tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs at a dose of 162 mg, irrespective of body weight, administered subcutaneously QW for 24 weeks. An additional 8 weeks were allotted for post-treatment evaluation of safety/immunogenicity.
86022|NCT02046616|O1|Outcome|Tocilizumab Alone or Combined With Methotrexate or Other DMARD|All participants received tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs at a dose of 162 mg, irrespective of body weight, administered subcutaneously QW for 24 weeks. An additional 8 weeks were allotted for post-treatment evaluation of safety/immunogenicity.
86023|NCT02046616|O1|Outcome|Tocilizumab Alone or Combined With Methotrexate or Other DMARD|All participants received tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs at a dose of 162 mg, irrespective of body weight, administered subcutaneously QW for 24 weeks. An additional 8 weeks were allotted for post-treatment evaluation of safety/immunogenicity.
86024|NCT02046616|O1|Outcome|Tocilizumab Alone or Combined With Methotrexate or Other DMARD|All participants received tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs at a dose of 162 mg, irrespective of body weight, administered subcutaneously QW for 24 weeks. An additional 8 weeks were allotted for post-treatment evaluation of safety/immunogenicity.
86025|NCT02046616|O1|Outcome|Tocilizumab Alone or Combined With Methotrexate or Other DMARD|All participants received tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs at a dose of 162 mg, irrespective of body weight, administered subcutaneously QW for 24 weeks. An additional 8 weeks were allotted for post-treatment evaluation of safety/immunogenicity.
86026|NCT02046616|O1|Outcome|Tocilizumab Alone or Combined With Methotrexate or Other DMARD|All participants received tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs at a dose of 162 mg, irrespective of body weight, administered subcutaneously QW for 24 weeks. An additional 8 weeks were allotted for post-treatment evaluation of safety/immunogenicity.
86027|NCT02046616|O1|Outcome|Tocilizumab Alone or Combined With Methotrexate or Other DMARD|All participants received tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs at a dose of 162 mg, irrespective of body weight, administered subcutaneously QW for 24 weeks. An additional 8 weeks were allotted for post-treatment evaluation of safety/immunogenicity.
86028|NCT02046616|O1|Outcome|Tocilizumab Alone or Combined With Methotrexate or Other DMARD|All participants received tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs at a dose of 162 mg, irrespective of body weight, administered subcutaneously QW for 24 weeks. An additional 8 weeks were allotted for post-treatment evaluation of safety/immunogenicity.
86029|NCT02046616|O1|Outcome|Tocilizumab Alone or Combined With Methotrexate or Other DMARD|All participants received tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs at a dose of 162 mg, irrespective of body weight, administered subcutaneously QW for 24 weeks. An additional 8 weeks were allotted for post-treatment evaluation of safety/immunogenicity.
86030|NCT02046616|O1|Outcome|Tocilizumab Alone or Combined With Methotrexate or Other DMARD|All participants received tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs at a dose of 162 mg, irrespective of body weight, administered subcutaneously QW for 24 weeks. An additional 8 weeks were allotted for post-treatment evaluation of safety/immunogenicity.
86031|NCT02046616|O1|Outcome|Tocilizumab Alone or Combined With Methotrexate or Other DMARD|All participants received tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs at a dose of 162 mg, irrespective of body weight, administered subcutaneously QW for 24 weeks. An additional 8 weeks were allotted for post-treatment evaluation of safety/immunogenicity.
86032|NCT02046616|E1|Reported Event|Tocilizumab Alone or Combined With Methotrexate or Other DMARD|All participants received tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs at a dose of 162 mg, irrespective of body weight, administered subcutaneously QW for 24 weeks. An additional 8 weeks were allotted for post-treatment evaluation of safety/immunogenicity.
86033|NCT02046564|B3|Baseline|Total|Total of all reporting groups
86034|NCT02046564|B2|Baseline|Placebo|The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
86035|NCT02046564|B1|Baseline|ASC-01|"Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet~Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet~Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet~Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6."
86036|NCT02046564|P2|Participant Flow|Placebo|The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
86037|NCT02046564|P1|Participant Flow|ASC-01|"Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet~Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet~Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet~Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6."
88426|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
86039|NCT02046564|O1|Outcome|ASC-01|"Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet~Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet~Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet~Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6."
86040|NCT02046564|O2|Outcome|Placebo|The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
86041|NCT02046564|O1|Outcome|ASC-01|"Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet~Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet~Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet~Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6."
86042|NCT02046564|O2|Outcome|Placebo|The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
86043|NCT02046564|O1|Outcome|ASC-01|"Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet~Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet~Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet~Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6."
86044|NCT02046564|O2|Outcome|Placebo|The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
86045|NCT02046564|O1|Outcome|ASC-01|"Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet~Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet~Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet~Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6."
86046|NCT02046564|O2|Outcome|Placebo|The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
86047|NCT02046564|O1|Outcome|ASC-01|"Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet~Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet~Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet~Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6."
86048|NCT02046564|O2|Outcome|Placebo|The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
86049|NCT02046564|O1|Outcome|ASC-01|"Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet~Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet~Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet~Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6."
86050|NCT02046564|O2|Outcome|Placebo|The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
86051|NCT02046564|O1|Outcome|ASC-01|"Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet~Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet~Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet~Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6."
86052|NCT02046564|O2|Outcome|Placebo|The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
86053|NCT02046564|O1|Outcome|ASC-01|"Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet~Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet~Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet~Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6."
86054|NCT02046564|O2|Outcome|Placebo|The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
86055|NCT02046564|O1|Outcome|ASC-01|"Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet~Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet~Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet~Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6."
86056|NCT02046564|E2|Reported Event|Placebo|The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily.
86057|NCT02046564|E1|Reported Event|ASC-01|"Formulation A: ASC-01 (aripiprazole/sertraline combination) 3 mg/100 mg tablet~Formulation B: ASC-01 (aripiprazole/sertraline combination) 6 mg/100 mg tablet~Formulation C: ASC-01 (aripiprazole/sertraline combination) 9 mg/100 mg tablet~Formulation D: ASC-01 (aripiprazole/sertraline combination) 12 mg/100 mg tablet Formulation A or, B, C, or D was orally administered once daily. For Week 1, Formulation A was administered after which administration was conducted according to the dose-increase criteria. The formulation was fixed from Week 5 to Week 6."
86058|NCT02046382|B3|Baseline|Total|Total of all reporting groups
86086|NCT02046369|O2|Outcome|Placebo|"Placebo administered once daily~Placebo: Placebo Comparator once daily"
87471|NCT02039414|E2|Reported Event|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
86059|NCT02046382|B2|Baseline|Normal Saline|"Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.~Placebo: 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given."
86060|NCT02046382|B1|Baseline|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.~IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given."
86061|NCT02046382|P2|Participant Flow|Normal Saline|"Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.~Placebo: 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given."
86062|NCT02046382|P1|Participant Flow|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.~IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given."
86063|NCT02046382|O2|Outcome|Normal Saline|"Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.~Placebo: 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given."
86064|NCT02046382|O1|Outcome|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.~IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given."
86065|NCT02046382|O2|Outcome|Normal Saline|"Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.~Placebo: 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given."
86066|NCT02046382|O1|Outcome|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.~IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given."
86067|NCT02046382|O2|Outcome|Normal Saline|"Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.~Placebo: 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given."
86068|NCT02046382|O1|Outcome|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.~IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given."
86069|NCT02046382|O2|Outcome|Normal Saline|"Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.~Placebo: 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given."
86070|NCT02046382|O1|Outcome|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.~IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given."
86071|NCT02046382|E2|Reported Event|Normal Saline|"Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.~Placebo: 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given."
86072|NCT02046382|E1|Reported Event|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.~IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given."
86073|NCT02046369|B3|Baseline|Total|Total of all reporting groups
86074|NCT02046369|B2|Baseline|Placebo|"Placebo administered once daily~Placebo: Placebo Comparator once daily"
86075|NCT02046369|B1|Baseline|Luradisone|"Luradisone 20- 80 mg administered once daily~Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily"
86076|NCT02046369|P2|Participant Flow|Placebo|"Placebo administered once daily~Placebo: Placebo Comparator once daily"
86077|NCT02046369|P1|Participant Flow|Luradisone|"Luradisone 20- 80 mg administered once daily~Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily"
86078|NCT02046369|O2|Outcome|Placebo|"Placebo administered once daily~Placebo: Placebo Comparator once daily"
86079|NCT02046369|O1|Outcome|Luradisone|"Luradisone 20- 80 mg administered once daily~Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily"
86080|NCT02046369|O2|Outcome|Placebo|"Placebo administered once daily~Placebo: Placebo Comparator once daily"
86081|NCT02046369|O1|Outcome|Luradisone|"Luradisone 20- 80 mg administered once daily~Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily"
86087|NCT02046369|O1|Outcome|Luradisone|"Luradisone 20- 80 mg administered once daily~Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily"
86088|NCT02046369|O2|Outcome|Placebo|"Placebo administered once daily~Placebo: Placebo Comparator once daily"
86089|NCT02046369|O1|Outcome|Luradisone|"Luradisone 20- 80 mg administered once daily~Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily"
86090|NCT02046369|E2|Reported Event|Placebo|"Placebo administered once daily~Placebo: Placebo Comparator once daily"
86091|NCT02046369|E1|Reported Event|Luradisone|"Luradisone 20- 80 mg administered once daily~Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily"
86092|NCT02046265|B5|Baseline|Total|Total of all reporting groups
86093|NCT02046265|B4|Baseline|Offered HPV Vaccine Only|"Participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Offered HPV vaccine only: Participant is offered the HPV vaccine only by their nurse practitioner in clinic."
86094|NCT02046265|B3|Baseline|Step up to Prevention|"Participant receives both the knowledge session and the tailored belief sessions and the participant is offered the HPV vaccine only by their nurse practitioner in clinic. This combined intervention is call Step Up to Prevention.~Step Up to Prevention: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
86095|NCT02046265|B2|Baseline|Step Up to Prevention:Belief|"Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Step Up to Prevention:belief: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
86096|NCT02046265|B1|Baseline|Step Up to Prevention: Knowledge|"Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Step Up to Prevention: knowledge: Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
86097|NCT02046265|P4|Participant Flow|Offered HPV Vaccine Only|"Participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Offered HPV vaccine only: Participant is offered the HPV vaccine only by their nurse practitioner in clinic."
86098|NCT02046265|P3|Participant Flow|Step up to Prevention|"Participant receives both the knowledge session and the tailored belief sessions and the participant is offered the HPV vaccine only by their nurse practitioner in clinic. This combined intervention is call Step Up to Prevention.~Step Up to Prevention: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
86099|NCT02046265|P2|Participant Flow|Step Up to Prevention:Belief|"Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Step Up to Prevention:belief: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
86100|NCT02046265|P1|Participant Flow|Step Up to Prevention: Knowledge|"Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Step Up to Prevention: knowledge: Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
86101|NCT02046265|O4|Outcome|Offered HPV Vaccine Only|"Participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Offered HPV vaccine only: Participant is offered the HPV vaccine only by their nurse practitioner in clinic."
86102|NCT02046265|O3|Outcome|Step up to Prevention|"Participant receives both the knowledge session and the tailored belief sessions and the participant is offered the HPV vaccine only by their nurse practitioner in clinic. This combined intervention is call Step Up to Prevention.~Step Up to Prevention: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
86103|NCT02046265|O2|Outcome|Step Up to Prevention:Belief|"Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Step Up to Prevention:belief: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
86104|NCT02046265|O1|Outcome|Step Up to Prevention: Knowledge|"Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Step Up to Prevention: knowledge: Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
86105|NCT02046265|E4|Reported Event|Offered HPV Vaccine Only|"Participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Offered HPV vaccine only: Participant is offered the HPV vaccine only by their nurse practitioner in clinic."
86106|NCT02046265|E3|Reported Event|Step up to Prevention|"Participant receives both the knowledge session and the tailored belief sessions and the participant is offered the HPV vaccine only by their nurse practitioner in clinic. This combined intervention is call Step Up to Prevention.~Step Up to Prevention: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
86107|NCT02046265|E2|Reported Event|Step Up to Prevention:Belief|"Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Step Up to Prevention:belief: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
86108|NCT02046265|E1|Reported Event|Step Up to Prevention: Knowledge|"Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Step Up to Prevention: knowledge: Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
86146|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
86109|NCT02046226|B1|Baseline|All Study Participants|The seven study subjects were treated with OxyGenesys(TM) Dissolved Oxygen Dressing or standard wound care using gauze dressings per institutional standard of care. The randomization of these subjects to either of these treatments was not indicated in each of the case report forms.
86110|NCT02046226|P1|Participant Flow|All Study Participants|The seven study subjects were treated with OxyGenesys(TM) Dissolved Oxygen Dressing or standard wound care using gauze dressings per institutional standard of care. The randomization of these subjects to either of these treatments was not indicated in each of the case report forms.
86111|NCT02046226|O2|Outcome|Standard Wound Care|Standard wound care using gauze dressings per institutional standard of care.
86112|NCT02046226|O1|Outcome|OxyGenesys(TM) Dissolved Oxygen Dressing|"OxyGenesys(TM) Dissolved Oxygen Dressing~Oxygenesys(TM) Dissolved Oxygen Dressing: OxyGenesys(TM) Dissolved Oxygen Dressing"
86113|NCT02046226|O2|Outcome|Standard Wound Care|Standard wound care using gauze dressings per institutional standard of care.
86114|NCT02046226|O1|Outcome|OxyGenesys(TM) Dissolved Oxygen Dressing|"OxyGenesys(TM) Dissolved Oxygen Dressing~Oxygenesys(TM) Dissolved Oxygen Dressing: OxyGenesys(TM) Dissolved Oxygen Dressing"
86115|NCT02046226|E1|Reported Event|All Study Participants|The seven study subjects were treated with OxyGenesys(TM) Dissolved Oxygen Dressing or standard wound care using gauze dressings per institutional standard of care. The randomization of these subjects to either of these treatments was not indicated on each case report form.
86116|NCT02046200|B1|Baseline|IVM 30mg; Placebo|"Ivermectin (IVM): Single dose (30 mg) of a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.~Placebo: Single dose sugar pill matched to active medication."
86117|NCT02046200|P2|Participant Flow|Placebo First, Then IVM 30 mg|"First Intervention, Placebo: Single dose sugar pill, matched to active medication.~Second Intervention, Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin."
86118|NCT02046200|P1|Participant Flow|IVM 30mg First, Then Placebo|"First Intervention, Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.~Second Intervention, Placebo: Single dose sugar pill, matched to active medication."
86119|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
86120|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
86121|NCT02046200|O1|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
86122|NCT02046200|O1|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
86123|NCT02046200|O1|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
86124|NCT02046200|O1|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
86125|NCT02046200|O6|Outcome|IVM 30mg (BrAC = 0.08)|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.08.
86126|NCT02046200|O5|Outcome|IVM 30mg (BrAC = 0.04)|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.04.
86127|NCT02046200|O4|Outcome|IVM 30mg (BrAC = 0.00)|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is at beginning of alcohol infusion when BrAC is still 0.00.
86128|NCT02046200|O3|Outcome|Placebo (BrAC = 0.08)|Single dose sugar pill, matched to active medication. Timepoint is during alcohol infusion when BrAC has reached 0.08.
86129|NCT02046200|O2|Outcome|Placebo (BrAC = 0.04)|Single dose sugar pill, matched to active medication. Timepoint is during alcohol infusion when BrAC has reached 0.04.
86130|NCT02046200|O1|Outcome|Placebo (BrAC = 0.00)|Single dose sugar pill, matched to active medication. Timepoint is at beginning of alcohol infusion when BrAC is still 0.00.
86131|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
86132|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
86133|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
86134|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
86135|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
86136|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
86137|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
86138|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
86139|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
86140|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
86141|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
86142|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
86143|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
86144|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
86145|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
86147|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
86148|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
86149|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
86150|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
86151|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
86152|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
86153|NCT02046200|E2|Reported Event|Placebo|"Matched placebo, single dose~Placebo: sugar pill~Alcohol"
86154|NCT02046200|E1|Reported Event|IVM 30mg|"Ivermectin 30 mg single dose~Ivermectin: Ivermectin is a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum antiparasitic avermectin.~Alcohol"
86155|NCT02046148|B3|Baseline|Total|Total of all reporting groups
86156|NCT02046148|B2|Baseline|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86157|NCT02046148|B1|Baseline|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86158|NCT02046148|P2|Participant Flow|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86159|NCT02046148|P1|Participant Flow|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86160|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86161|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86162|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86163|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86164|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86165|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86166|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86167|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86168|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86169|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86170|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86249|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86171|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86172|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86173|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86174|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86175|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86176|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86177|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86178|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86179|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86180|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86181|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86182|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86183|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86184|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86185|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86186|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86187|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86188|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86189|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
87472|NCT02039414|E1|Reported Event|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
86190|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86191|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86192|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86193|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86194|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86195|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86196|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86197|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86198|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86199|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86200|NCT02046148|E2|Reported Event|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86201|NCT02046148|E1|Reported Event|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
86202|NCT02045836|B3|Baseline|Total|Total of all reporting groups
86203|NCT02045836|B2|Baseline|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86204|NCT02045836|B1|Baseline|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86205|NCT02045836|P2|Participant Flow|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86206|NCT02045836|P1|Participant Flow|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86207|NCT02045836|O2|Outcome|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86208|NCT02045836|O1|Outcome|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86430|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
87473|NCT02039115|B3|Baseline|Total|Total of all reporting groups
86209|NCT02045836|O2|Outcome|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86210|NCT02045836|O1|Outcome|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86211|NCT02045836|O2|Outcome|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86212|NCT02045836|O1|Outcome|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86213|NCT02045836|O2|Outcome|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86214|NCT02045836|O1|Outcome|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86215|NCT02045836|O2|Outcome|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86216|NCT02045836|O1|Outcome|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm .
86217|NCT02045836|O2|Outcome|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86218|NCT02045836|O1|Outcome|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86219|NCT02045836|O2|Outcome|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86220|NCT02045836|O1|Outcome|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86221|NCT02045836|O2|Outcome|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86222|NCT02045836|O1|Outcome|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86223|NCT02045836|O2|Outcome|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86224|NCT02045836|O1|Outcome|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86225|NCT02045836|O2|Outcome|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86226|NCT02045836|O1|Outcome|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86227|NCT02045836|O2|Outcome|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86228|NCT02045836|O1|Outcome|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86229|NCT02045836|O2|Outcome|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86230|NCT02045836|O1|Outcome|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86231|NCT02045836|O1|Outcome|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86232|NCT02045836|E2|Reported Event|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86233|NCT02045836|E1|Reported Event|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
86234|NCT02045797|B4|Baseline|Total|Total of all reporting groups
86235|NCT02045797|B3|Baseline|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86236|NCT02045797|B2|Baseline|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86237|NCT02045797|B1|Baseline|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86238|NCT02045797|P3|Participant Flow|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV every 8 hours (q8h) three times a day (TID) on Day 1 and Day 2 . Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86239|NCT02045797|P2|Participant Flow|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86240|NCT02045797|P1|Participant Flow|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 milligrams (mg) intravenous (IV) every 12 hours (q12h; twice daily [BID]) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86241|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86242|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86243|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86244|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86245|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86246|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86247|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86248|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
88427|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
86250|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86251|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86252|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86253|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86254|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86255|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86256|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86257|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86258|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86259|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86260|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86261|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86262|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86263|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86264|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86265|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86266|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86267|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86268|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86269|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86270|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86271|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86272|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86273|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
88428|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
86274|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86275|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86276|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86277|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86278|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86279|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86280|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86281|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86282|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86283|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86284|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86285|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86286|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86287|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86288|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86289|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86290|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86291|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86292|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86293|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86294|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86295|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86296|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86297|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
88429|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
86298|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86299|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86300|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86301|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86302|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86303|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86304|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86305|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86306|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86307|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86308|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86309|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86310|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86311|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86312|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86313|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86314|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86315|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86316|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86317|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86318|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86319|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86320|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86321|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
88430|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
86322|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86323|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86324|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86325|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86326|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86327|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86328|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86329|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86330|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86331|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86332|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86333|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86334|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86335|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86336|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86337|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86338|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86339|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86340|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86341|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86342|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86343|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86344|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86345|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86346|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86347|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86348|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86349|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86350|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86351|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86352|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86353|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86354|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86355|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86356|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86357|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86358|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86359|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86360|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86361|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86362|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86363|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86364|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86365|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86366|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86367|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86368|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86369|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86370|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86371|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86372|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86373|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86374|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86375|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86376|NCT02045797|O3|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86377|NCT02045797|O2|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86378|NCT02045797|O1|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86379|NCT02045797|E3|Reported Event|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
86380|NCT02045797|E2|Reported Event|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
86381|NCT02045797|E1|Reported Event|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
86382|NCT02045732|B3|Baseline|Total|Total of all reporting groups
86383|NCT02045732|B2|Baseline|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
86384|NCT02045732|B1|Baseline|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
86385|NCT02045732|P2|Participant Flow|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 milligram (mg)/kilogram (kg) SC every other week during an 85-day treatment period.
86386|NCT02045732|P1|Participant Flow|Placebo|Participants received placebo subcutaneously (SC) every other week during an 85-day treatment period.
86387|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
86388|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
86389|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
86390|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
86391|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
86392|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
86393|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
86394|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
86395|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
86396|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
86397|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
86398|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
86399|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
86400|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
86401|NCT02045732|E2|Reported Event|PF-06342674|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
86402|NCT02045732|E1|Reported Event|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
86403|NCT02045511|B3|Baseline|Total|Total of all reporting groups
86404|NCT02045511|B2|Baseline|Delayed Treatment Group|"3-month delayed treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
86431|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
86405|NCT02045511|B1|Baseline|Immediate Treatment Group|"Immediate treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
86406|NCT02045511|P2|Participant Flow|Delayed Treatment Group|"3-month delayed treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
86407|NCT02045511|P1|Participant Flow|Immediate Treatment Group|"Immediate treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
86408|NCT02045511|O2|Outcome|Delayed Treatment Group|"3-month delayed treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
86409|NCT02045511|O1|Outcome|Immediate Treatment Group|"Immediate treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
86410|NCT02045511|O2|Outcome|Delayed Treatment Group|"3-month delayed treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
86411|NCT02045511|O1|Outcome|Immediate Treatment Group|"Immediate treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
86412|NCT02045511|O2|Outcome|Delayed Treatment Group|"3-month delayed treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
86413|NCT02045511|O1|Outcome|Immediate Treatment Group|"Immediate treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
86414|NCT02045511|O2|Outcome|Delayed Treatment Group|"3-month delayed treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
86415|NCT02045511|O1|Outcome|Immediate Treatment Group|"Immediate treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
86416|NCT02045511|O2|Outcome|Delayed Treatment Group|"3-month delayed treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
86417|NCT02045511|O1|Outcome|Immediate Treatment Group|"Immediate treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
86418|NCT02045511|O2|Outcome|Delayed Treatment Group|"3-month delayed treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
86419|NCT02045511|O1|Outcome|Immediate Treatment Group|"Immediate treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
86420|NCT02045511|E2|Reported Event|Delayed Treatment Group|"3-month delayed treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
86421|NCT02045511|E1|Reported Event|Immediate Treatment Group|"Immediate treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
86422|NCT02045264|B1|Baseline|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
86423|NCT02045264|P1|Participant Flow|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
86424|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
86425|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
86426|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
86427|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
86428|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
86429|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
86432|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
86433|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
86434|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
86435|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
86436|NCT02045264|E1|Reported Event|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
86437|NCT02045238|B3|Baseline|Total|Total of all reporting groups
86438|NCT02045238|B2|Baseline|Hypertonic Saline|"Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
86439|NCT02045238|B1|Baseline|Normal Saline|"Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
86440|NCT02045238|P2|Participant Flow|Hypertonic Saline|"Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
86441|NCT02045238|P1|Participant Flow|Normal Saline|"Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
86442|NCT02045238|O2|Outcome|Hypertonic Saline|"Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
86443|NCT02045238|O1|Outcome|Normal Saline|"Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
86444|NCT02045238|O2|Outcome|Hypertonic Saline|"Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
86445|NCT02045238|O1|Outcome|Normal Saline|"Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
86446|NCT02045238|E2|Reported Event|Hypertonic Saline|"Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
86447|NCT02045238|E1|Reported Event|Normal Saline|"Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
86448|NCT02045108|B5|Baseline|Total|Total of all reporting groups
86449|NCT02045108|B4|Baseline|Sham TDCS + Sham Retraining|"0.1 mA of TDCS applied during sham alcohol avoidance retraining~Sham TDCS~Sham Retraining"
86450|NCT02045108|B3|Baseline|Active TDCS + Sham Retraining|"2.0 mA of TDCS applied during sham alcohol avoidance retraining~Active TDCS~Sham Retraining"
86451|NCT02045108|B2|Baseline|Sham TDCS + Active Retraining|".1 mA of TDCS applied during active alcohol avoidance retraining~Active Retraining~Sham TDCS"
86452|NCT02045108|B1|Baseline|Active TDCS + Active Retraining|"2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining~Active Retraining~Active TDCS"
86453|NCT02045108|P4|Participant Flow|Sham TDCS + Sham Retraining|"0.1 mA of TDCS applied during sham alcohol avoidance retraining~Sham TDCS~Sham Retraining"
86454|NCT02045108|P3|Participant Flow|Active TDCS + Sham Retraining|"2.0 mA of TDCS applied during sham alcohol avoidance retraining~Active TDCS~Sham Retraining"
86455|NCT02045108|P2|Participant Flow|Sham TDCS + Active Retraining|".1 mA of TDCS applied during active alcohol avoidance retraining~Active Retraining~Sham TDCS"
86456|NCT02045108|P1|Participant Flow|Active TDCS + Active Retraining|"2.0 milliamps (mA) of transcranial direct current stimulation (TDCS) applied during active alcohol avoidance retraining~Active Retraining~Active TDCS"
86457|NCT02045108|O4|Outcome|Sham TDCS + Sham Retraining|"0.1 mA of TDCS applied during sham alcohol avoidance retraining~Sham TDCS~Sham Retraining"
86458|NCT02045108|O3|Outcome|Active TDCS + Sham Retraining|"2.0 mA of TDCS applied during sham alcohol avoidance retraining~Active TDCS~Sham Retraining"
86459|NCT02045108|O2|Outcome|Sham TDCS + Active Retraining|".1 mA of TDCS applied during active alcohol avoidance retraining~Active Retraining~Sham TDCS"
86460|NCT02045108|O1|Outcome|Active TDCS + Active Retraining|"2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining~Active Retraining~Active TDCS"
86461|NCT02045108|O4|Outcome|Sham TDCS + Sham Retraining|"0.1 mA of TDCS applied during sham alcohol avoidance retraining~Sham TDCS~Sham Retraining"
86462|NCT02045108|O3|Outcome|Active TDCS + Sham Retraining|"2.0 mA of TDCS applied during sham alcohol avoidance retraining~Active TDCS~Sham Retraining"
86463|NCT02045108|O2|Outcome|Sham TDCS + Active Retraining|".1 mA of TDCS applied during active alcohol avoidance retraining~Active Retraining~Sham TDCS"
86464|NCT02045108|O1|Outcome|Active TDCS + Active Retraining|"2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining~Active Retraining~Active TDCS"
86465|NCT02045108|O4|Outcome|Sham TDCS + Sham Retraining|"0.1 mA of TDCS applied during sham alcohol avoidance retraining~Sham TDCS~Sham Retraining"
86466|NCT02045108|O3|Outcome|Active TDCS + Sham Retraining|"2.0 mA of TDCS applied during sham alcohol avoidance retraining~Active TDCS~Sham Retraining"
86467|NCT02045108|O2|Outcome|Sham TDCS + Active Retraining|".1 mA of TDCS applied during active alcohol avoidance retraining~Active Retraining~Sham TDCS"
86468|NCT02045108|O1|Outcome|Active TDCS + Active Retraining|"2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining~Active Retraining~Active TDCS"
86469|NCT02045108|O4|Outcome|Sham TDCS + Sham Retraining|"0.1 mA of TDCS applied during sham alcohol avoidance retraining~Sham TDCS~Sham Retraining"
86470|NCT02045108|O3|Outcome|Active TDCS + Sham Retraining|"2.0 mA of TDCS applied during sham alcohol avoidance retraining~Active TDCS~Sham Retraining"
86471|NCT02045108|O2|Outcome|Sham TDCS + Active Retraining|".1 mA of TDCS applied during active alcohol avoidance retraining~Active Retraining~Sham TDCS"
86472|NCT02045108|O1|Outcome|Active TDCS + Active Retraining|"2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining~Active Retraining~Active TDCS"
86473|NCT02045108|O4|Outcome|Sham TDCS + Sham Retraining|"0.1 mA of TDCS applied during sham alcohol avoidance retraining~Sham TDCS~Sham Retraining"
86474|NCT02045108|O3|Outcome|Active TDCS + Sham Retraining|"2.0 mA of TDCS applied during sham alcohol avoidance retraining~Active TDCS~Sham Retraining"
86475|NCT02045108|O2|Outcome|Sham TDCS + Active Retraining|".1 mA of TDCS applied during active alcohol avoidance retraining~Active Retraining~Sham TDCS"
86476|NCT02045108|O1|Outcome|Active TDCS + Active Retraining|"2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining~Active Retraining~Active TDCS"
86477|NCT02045108|O4|Outcome|Sham TDCS + Sham Retraining|"0.1 mA of TDCS applied during sham alcohol avoidance retraining~Sham TDCS~Sham Retraining"
86478|NCT02045108|O3|Outcome|Active TDCS + Sham Retraining|"2.0 mA of TDCS applied during sham alcohol avoidance retraining~Active TDCS~Sham Retraining"
86479|NCT02045108|O2|Outcome|Sham TDCS + Active Retraining|".1 mA of TDCS applied during active alcohol avoidance retraining~Active Retraining~Sham TDCS"
86480|NCT02045108|O1|Outcome|Active TDCS + Active Retraining|"2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining~Active Retraining~Active TDCS"
86481|NCT02045108|O4|Outcome|Sham TDCS + Sham Retraining|"0.1 mA of TDCS applied during sham alcohol avoidance retraining~Sham TDCS~Sham Retraining"
86482|NCT02045108|O3|Outcome|Active TDCS + Sham Retraining|"2.0 mA of TDCS applied during sham alcohol avoidance retraining~Active TDCS~Sham Retraining"
86483|NCT02045108|O2|Outcome|Sham TDCS + Active Retraining|".1 mA of TDCS applied during active alcohol avoidance retraining~Active Retraining~Sham TDCS"
86484|NCT02045108|O1|Outcome|Active TDCS + Active Retraining|"2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining~Active Retraining~Active TDCS"
86485|NCT02045108|O4|Outcome|Sham TDCS + Sham Retraining|"0.1 mA of TDCS applied during sham alcohol avoidance retraining~Sham TDCS~Sham Retraining"
86486|NCT02045108|O3|Outcome|Active TDCS + Sham Retraining|"2.0 mA of TDCS applied during sham alcohol avoidance retraining~Active TDCS~Sham Retraining"
86487|NCT02045108|O2|Outcome|Sham TDCS + Active Retraining|".1 mA of TDCS applied during active alcohol avoidance retraining~Active Retraining~Sham TDCS"
86488|NCT02045108|O1|Outcome|Active TDCS + Active Retraining|"2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining~Active Retraining~Active TDCS"
86489|NCT02045108|O4|Outcome|Sham TDCS + Sham Retraining|"0.1 mA of TDCS applied during sham alcohol avoidance retraining~Sham TDCS~Sham Retraining"
86490|NCT02045108|O3|Outcome|Active TDCS + Sham Retraining|"2.0 mA of TDCS applied during sham alcohol avoidance retraining~Active TDCS~Sham Retraining"
86491|NCT02045108|O2|Outcome|Sham TDCS + Active Retraining|".1 mA of TDCS applied during active alcohol avoidance retraining~Active Retraining~Sham TDCS"
88269|NCT02037477|O2|Outcome|Cohort 1 - Esomeprazole 20 mg|Esomeprazole 20 mg, orally, once daily for 7 days.
86492|NCT02045108|O1|Outcome|Active TDCS + Active Retraining|"2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining~Active Retraining~Active TDCS"
86493|NCT02045108|O4|Outcome|Sham TDCS + Sham Retraining|"0.1 mA of TDCS applied during sham alcohol avoidance retraining~Sham TDCS~Sham Retraining"
86494|NCT02045108|O3|Outcome|Active TDCS + Sham Retraining|"2.0 mA of TDCS applied during sham alcohol avoidance retraining~Active TDCS~Sham Retraining"
86495|NCT02045108|O2|Outcome|Sham TDCS + Active Retraining|".1 mA of TDCS applied during active alcohol avoidance retraining~Active Retraining~Sham TDCS"
86496|NCT02045108|O1|Outcome|Active TDCS + Active Retraining|"2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining~Active Retraining~Active TDCS"
86497|NCT02045108|E4|Reported Event|Sham TDCS + Sham Retraining|"0.1 mA of TDCS applied during sham alcohol avoidance retraining~Sham TDCS~Sham Retraining"
86498|NCT02045108|E3|Reported Event|Active TDCS + Sham Retraining|"2.0 mA of TDCS applied during sham alcohol avoidance retraining~Active TDCS~Sham Retraining"
86499|NCT02045108|E2|Reported Event|Sham TDCS + Active Retraining|".1 mA of TDCS applied during active alcohol avoidance retraining~Active Retraining~Sham TDCS"
86500|NCT02045108|E1|Reported Event|Active TDCS + Active Retraining|"2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining~Active Retraining~Active TDCS"
86501|NCT02044991|B3|Baseline|Total|Total of all reporting groups
86502|NCT02044991|B2|Baseline|Placebo|Participant's randomized to this condition receive a saline injection with lidocaine.
86503|NCT02044991|B1|Baseline|Treatment|Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine
86504|NCT02044991|P2|Participant Flow|Placebo|Participant's randomized to this condition receive a saline injection with lidocaine.
86505|NCT02044991|P1|Participant Flow|Treatment|Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine
86506|NCT02044991|O2|Outcome|Placebo|Participant's randomized to this condition receive a saline injection with lidocaine.
86507|NCT02044991|O1|Outcome|Treatment|Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine
86508|NCT02044991|O2|Outcome|Placebo|Participant's randomized to this condition receive a saline injection with lidocaine.
86509|NCT02044991|O1|Outcome|Treatment|Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine
86510|NCT02044991|O2|Outcome|Placebo|Participant's randomized to this condition receive a saline injection with lidocaine.
86511|NCT02044991|O1|Outcome|Treatment|Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine
86512|NCT02044991|E2|Reported Event|Placebo|Participant's randomized to this condition receive a saline injection with lidocaine.
86513|NCT02044991|E1|Reported Event|Treatment|Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine
86514|NCT02044848|B3|Baseline|Total|Total of all reporting groups
86515|NCT02044848|B2|Baseline|Placebo|Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
86516|NCT02044848|B1|Baseline|Secukinumab|Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
86517|NCT02044848|P2|Participant Flow|Placebo|Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
86518|NCT02044848|P1|Participant Flow|Secukinumab|Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
86519|NCT02044848|O2|Outcome|Placebo|Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
86520|NCT02044848|O1|Outcome|Secukinumab|Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
86521|NCT02044848|E2|Reported Event|Placebo|Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
86522|NCT02044848|E1|Reported Event|Secukinumab|Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
86523|NCT02044822|B1|Baseline|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
86524|NCT02044822|P1|Participant Flow|Idelalisib + Rituximab|Idelalisib (Zydelig®) 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
86525|NCT02044822|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
86526|NCT02044822|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
86527|NCT02044822|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
86528|NCT02044822|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
86529|NCT02044822|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
86530|NCT02044822|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
86531|NCT02044822|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
86532|NCT02044822|E1|Reported Event|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
86533|NCT02044458|B3|Baseline|Total|Total of all reporting groups
86534|NCT02044458|B2|Baseline|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
86535|NCT02044458|B1|Baseline|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.~Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
86536|NCT02044458|P2|Participant Flow|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
88270|NCT02037477|O1|Outcome|Cohort 1 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
86537|NCT02044458|P1|Participant Flow|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.~Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
86538|NCT02044458|O2|Outcome|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
86539|NCT02044458|O1|Outcome|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.~Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
86540|NCT02044458|O2|Outcome|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
86541|NCT02044458|O1|Outcome|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.~Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
86542|NCT02044458|O2|Outcome|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
86543|NCT02044458|O1|Outcome|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.~Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
86544|NCT02044458|E2|Reported Event|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
86545|NCT02044458|E1|Reported Event|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.~Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
86546|NCT02044419|B4|Baseline|Total|Total of all reporting groups
86547|NCT02044419|B3|Baseline|Intact Capsule, Applesauce, Mashed Banana (CAB)|"Contents of single 20 mg capsule of lomitapide sprinkled in applesauce& mashed banana~Capsule taken intact~lomitapide"
86548|NCT02044419|B2|Baseline|Mashed Banana, Intact Capsule, Applesauce (BCA)|"Contents of single 20 mg capsule of lomitapide sprinkled in applesauce& mashed banana~Capsule taken intact~lomitapide"
86549|NCT02044419|B1|Baseline|Applesauce, Mashed Banana, Intact Capsule (ABC)|"Contents of single 20 mg capsule of lomitapide sprinkled in applesauce, mashed banana~Capsule taken intact~lomitapide"
86550|NCT02044419|P3|Participant Flow|Intact Capsule, Applesauce, Mashed Banana (CAB)|First Intervention: Contents of single 20 mg capsule of lomitapide sprinkled in applesauce Second Intervention: Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana Third Intervention: Intact capsule of 20 mg lomitapide
86551|NCT02044419|P2|Participant Flow|Mashed Banana, Intact Capsule, Applesauce (BCA)|First Intervention: Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana Second Intervention: Intact capsule of 20 mg lomitapide Third Intervention: Contents of single 20 mg capsule of lomitapide sprinkled in applesauce
86552|NCT02044419|P1|Participant Flow|Applesauce, Mashed Banana, Intact Capsule (ABC)|First Intervention: Contents of single 20 mg capsule of lomitapide sprinkled in applesauce Second Intervention: Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana Third Intervention: Intact capsule of 20 mg lomitapide
86553|NCT02044419|O3|Outcome|Intact Capsule of 20 mg Lomitapide (Treatment C)|Intact capsule of 20 mg lomitapide
86554|NCT02044419|O2|Outcome|Lomitapide Sprinkled in Mashed Banana (Treatment B)|Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana
86555|NCT02044419|O1|Outcome|Lomitapide Sprinkled in Applesauce (Treatment A)|Contents of single 20 mg capsule of lomitapide sprinkled in applesauce
86556|NCT02044419|O3|Outcome|Intact Capsule of 20 mg Lomitapide (Treatment C)|Intact capsule of 20 mg lomitapide
86557|NCT02044419|O2|Outcome|Lomitapide Sprinkled in Mashed Banana (Treatment B)|Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana
86558|NCT02044419|O1|Outcome|Lomitapide Sprinkled in Applesauce (Treatment A)|Contents of single 20 mg capsule of lomitapide sprinkled in applesauce
86559|NCT02044419|O3|Outcome|Intact Capsule of 20 mg Lomitapide (Treatment C)|Intact capsule of 20 mg lomitapide
86560|NCT02044419|O2|Outcome|Lomitapide Sprinkled in Mashed Banana (Treatment B)|Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana
86561|NCT02044419|O1|Outcome|Lomitapide Sprinkled in Applesauce (Treatment A)|Contents of single 20 mg capsule of lomitapide sprinkled in applesauce
86562|NCT02044419|O3|Outcome|Intact Capsule of 20 mg Lomitapide (Treatment C)|Intact capsule of 20 mg lomitapide
86563|NCT02044419|O2|Outcome|Lomitapide Sprinkled in Mashed Banana (Treatment B)|Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana
86564|NCT02044419|O1|Outcome|Lomitapide Sprinkled in Applesauce (Treatment A)|Contents of single 20 mg capsule of lomitapide sprinkled in applesauce
86565|NCT02044419|O3|Outcome|Intact Capsule of 20 mg Lomitapide (Treatment C)|Intact capsule of 20 mg lomitapide
86566|NCT02044419|O2|Outcome|Lomitapide Sprinkled in Mashed Banana (Treatment B)|Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana
86567|NCT02044419|O1|Outcome|Lomitapide Sprinkled in Applesauce (Treatment A)|Contents of single 20 mg capsule of lomitapide sprinkled in applesauce
86568|NCT02044419|O3|Outcome|Intact Capsule of 20 mg Lomitapide (Treatment C)|Intact capsule of 20 mg lomitapide
86569|NCT02044419|O2|Outcome|Lomitapide Sprinkled in Mashed Banana (Treatment B)|Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana
86570|NCT02044419|O1|Outcome|Lomitapide Sprinkled in Applesauce (Treatment A)|Contents of single 20 mg capsule of lomitapide sprinkled in applesauce
86571|NCT02044419|E3|Reported Event|Intact Capsule of 20 mg Lomitapide (Treatment C)|Intact capsule of 20 mg lomitapide
86572|NCT02044419|E2|Reported Event|Lomitapide Sprinkled in Mashed Banana (Treatment B)|Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana
86573|NCT02044419|E1|Reported Event|Lomitapide Sprinkled in Applesauce (Treatment A)|Contents of single 20 mg capsule of lomitapide sprinkled in applesauce
86574|NCT02044393|B3|Baseline|Total|Total of all reporting groups
86597|NCT02044367|P4|Participant Flow|T2-R-T1|T2: granules for reconstitution into solution; R: hard capsule; T1: pellets on food. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
87182|NCT02040779|B3|Baseline|BDP 160 mcg BAI|80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
86575|NCT02044393|B2|Baseline|BI 691751 / IT+BI 691751|"Subjects in treatment sequence of reference drug treatment in period 1, then tested drug treatment in period 2 (R/T): One tablet of 10 mg BI 691751 was given as a single dose on Day 1 in period 1. Two capsules of 100 mg itraconazole were given twice daily on Day -3 (loading dose) and once daily on Day -2 to Day 7 (10 days of itraconazol treatment in total), and, 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 (corresponding to the fourth day of the 10-day itraconazole treatment) in period 2.~Oral administration with 240 mL water after intake of a standaridsed meal."
86576|NCT02044393|B1|Baseline|Itraconazole (IT) +BI 691751 / BI 691751|"Subjects in treatment sequence of tested drug treatment in period 1, then reference drug treatment in period 2 (T/R): two capsules of 100 mg itraconazole were given twice daily on Day -3 (loading dose) and once daily on Day -2 to Day 7 (10 days of itraconazol treatment in total). In addition, 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 (corresponding to the fourth day of the 10-day itraconazole treatment) in period 1. One tablet of 10 mg BI 691751 was given as a single dose on Day 1 in period 2.~The BI 691751 single dose administrations in the 2 treatment periods were separated by a washout period of at least 7 weeks.~Oral administration with 240 mL water after intake of a standardised meal."
86577|NCT02044393|P2|Participant Flow|BI 691751 / IT+BI 691751|"Subjects in treatment sequence of reference drug treatment in period 1, then tested drug treatment in period 2 (R/T): One tablet of 10 mg BI 691751 was given as a single dose on Day 1 in period 1. Two capsules of 100 mg itraconazole were given twice daily on Day -3 (loading dose) and once daily on Day -2 to Day 7 (10 days of itraconazol treatment in total), and, 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 (corresponding to the fourth day of the 10-day itraconazole treatment) in period 2.~Oral administration with 240 mL water after intake of a standaridsed meal."
86578|NCT02044393|P1|Participant Flow|Itraconazole (IT) +BI 691751 / BI 691751|"Subjects in treatment sequence of tested drug treatment in period 1, then reference drug treatment in period 2 (T/R): two capsules of 100 mg itraconazole were given twice daily on Day -3 (loading dose) and once daily on Day -2 to Day 7 (10 days of itraconazol treatment in total). In addition, 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 (corresponding to the fourth day of the 10-day itraconazole treatment) in period 1. One tablet of 10 mg BI 691751 was given as a single dose on Day 1 in period 2.~The BI 691751 single dose administrations in the 2 treatment periods were separated by a washout period of at least 7 weeks.~Oral administration with 240 mL water after intake of a standardised meal."
86579|NCT02044393|O2|Outcome|IT + BI 691751|Two capsules of 100 mg IT were given twice daily on Day -3 and once daily on Day -2 to Day 7. 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 with 240 mL water after intake of a standard meal.
86580|NCT02044393|O1|Outcome|BI 691751|10 mg BI 691751 single dose oral administration with 240 mL water after intake of a standard meal.
86581|NCT02044393|O2|Outcome|IT + BI 691751|Two capsules of 100 mg IT were given twice daily on Day -3 and once daily on Day -2 to Day 7. 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 with 240 mL water after intake of a standard meal.
86582|NCT02044393|O1|Outcome|BI 691751|10 mg BI 691751 single dose oral administration with 240 mL water after intake of a standard meal.
86583|NCT02044393|O2|Outcome|IT + BI 691751|Two capsules of 100 mg IT were given twice daily on Day -3 and once daily on Day -2 to Day 7. 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 with 240 mL water after intake of a standard meal.
86584|NCT02044393|O1|Outcome|BI 691751|"single dose BI 691751~BI 691751: 10 mg single dose oral administration with 240 mL water after intake of a standard meal."
86585|NCT02044393|E5|Reported Event|Total on Treatment|combination of BI 691751, loading IT and BI 691751+ further IT.
86586|NCT02044393|E4|Reported Event|Total BI 691751|total subjects with BI 691751 treatment (either BI 691751 alone or IT+BI 691751)
86587|NCT02044393|E3|Reported Event|BI 691751 + Further IT|10 mg of BI 691751 in combination with multiple oral doses of itraconazole (only in the test treatment period after the introductory treatment with itraconazole alone over three days).
86588|NCT02044393|E2|Reported Event|Loading Itraconazole (IT)|200 mg of itraconazole (introductory treatment with itraconazole over three days, prior to the first administration of BI 691751 only in the test treatment period).
86589|NCT02044393|E1|Reported Event|BI 691751|10 mg single dose oral administration with 240 mL water after intake of a standard meal. (only in the reference treatment period)
86590|NCT02044380|B1|Baseline|Afatinib 40 mg|Patient to receive a film coated tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability.
86591|NCT02044380|P1|Participant Flow|Afatinib 40 mg|Patient to receive a film coated tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability.
86592|NCT02044380|O1|Outcome|Afatinib 40 mg|Patient to receive a film coated tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability.
86593|NCT02044380|E1|Reported Event|Afatinib 40 mg|Patient to receive a film coated tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability.
86594|NCT02044367|B1|Baseline|Overall|A randomised, open-label, 3-way crossover, multiple dose trial consisting of 3 identical treatment periods of 3 days. Study drug (150 mg dabigatran etexilate) was administrated twice daily on Day 1 and Day 2 and once on Day 3. The dosage forms used were: hard capsule, granules resolved in reconstitution solution and pellets on food. Treatment periods were separated by a washout phase of at least 5 days between last drug administration of one treatment and the first drug administration of the next treatment.
86595|NCT02044367|P6|Participant Flow|R-T2-T1|R: hard capsule; T2: granules for reconstitution into solution; T1: pellets on food. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
86596|NCT02044367|P5|Participant Flow|R-T1-T2|R: hard capsule; T1: pellets on food; T2: granules for reconstitution into solution. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
86621|NCT02044302|B2|Baseline|Blinded Group B|
86622|NCT02044302|B1|Baseline|Blinded Group A|
86623|NCT02044302|P2|Participant Flow|Blinded Group B|
86624|NCT02044302|P1|Participant Flow|Blinded Group A|
86598|NCT02044367|P3|Participant Flow|T2-T1-R|T2: granules for reconstitution into solution; T1: pellets on food; R: hard capsule. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
86599|NCT02044367|P2|Participant Flow|T1-R-T2|T1: pellets on food; R: hard capsule; T2: granules for reconstitution into solution. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
86600|NCT02044367|P1|Participant Flow|T1-T2-R|T1: pellets on food; T2: granules for reconstitution into solution; R: hard capsule. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
86601|NCT02044367|O2|Outcome|T2 (Treatment B)|"T2: Granules resolved in reconstitution solution~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water."
86602|NCT02044367|O1|Outcome|T1 (Treatment A)|"T1: Pellets on food~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water."
86603|NCT02044367|O2|Outcome|T2 (Treatment B)|T2: Granules resolved in reconstitution solution The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water.
86604|NCT02044367|O1|Outcome|T1 (Treatment A)|T1: Pellets on food The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water.
86605|NCT02044367|O3|Outcome|R (Reference)|"multiple dose of dabigatran (Hard capsule)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
86606|NCT02044367|O2|Outcome|T2 (Treatment B)|"multiple dose of dabigatran (Granules resolved in reconstitution solution)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
86607|NCT02044367|O1|Outcome|T1 (Treatment A)|"multiple dose of dabigatran (Pellets)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
86608|NCT02044367|O3|Outcome|R (Reference)|"multiple dose of dabigatran (Hard capsule)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
86609|NCT02044367|O2|Outcome|T2 (Treatment B)|"multiple dose of dabigatran (Granules resolved in reconstitution solution)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
86610|NCT02044367|O1|Outcome|T1 (Treatment A)|"multiple dose of dabigatran (Pellets)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
86611|NCT02044367|O3|Outcome|R (Reference)|"multiple dose of dabigatran (Hard capsule)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
86612|NCT02044367|O2|Outcome|T2 (Treatment B)|"multiple dose of dabigatran (Granules resolved in reconstitution solution)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
86613|NCT02044367|O1|Outcome|T1 (Treatment A)|"multiple dose of dabigatran (Pellets)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
86614|NCT02044367|O3|Outcome|R (Reference)|"multiple dose of dabigatran (Hard capsule)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
86615|NCT02044367|O2|Outcome|T2 (Treatment B)|"multiple dose of dabigatran (Granules resolved in reconstitution solution)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
86616|NCT02044367|O1|Outcome|T1 (Treatment A)|"multiple dose of dabigatran (Pellets)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
86617|NCT02044367|E3|Reported Event|R (Reference)|multiple dose of dabigatran (Hard capsule) The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
86618|NCT02044367|E2|Reported Event|T2 (Treatment B)|multiple dose of dabigatran (Granules resolved in reconstitution solution) The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
86619|NCT02044367|E1|Reported Event|T1 (Treatment A)|multiple dose of dabigatran (Pellets). The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
86620|NCT02044302|B3|Baseline|Total|Total of all reporting groups
86629|NCT02044094|B1|Baseline|Depot Buprenorphine|Participants were treated with RBP-6000 300-mg in a single subcutaneous injection on Days 1 and 29. Challenges consist of participants receiving on three consecutive days intramuscular (IM) injections of hydromorphone randomly assigned at 0 mg (placebo), 6 mg and 18 mg doses during weeks 1-12.
86630|NCT02044094|P1|Participant Flow|Depot Buprenorphine|Participants were treated with RBP-6000 300-mg in a single subcutaneous injection on Days 1 and 29. Challenges consist of participants receiving on three consecutive days intramuscular (IM) injections of hydromorphone randomly assigned at 0 mg (placebo), 6 mg and 18 mg doses during weeks 1-12.
86631|NCT02044094|O2|Outcome|Hydromorphone 18 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 18 mg hydromorphone.
86632|NCT02044094|O1|Outcome|Hydromorphone 6 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 6 mg hydromorphone.
86633|NCT02044094|O3|Outcome|Hydromorphone 18 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 18 mg hydromorphone.
86634|NCT02044094|O2|Outcome|Hydromorphone 6 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 6 mg hydromorphone.
86635|NCT02044094|O1|Outcome|Placebo|During hydromorphone challenges, participants received intramuscular (IM) injections of placebo.
86636|NCT02044094|O2|Outcome|Hydromorphone 18 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 18 mg hydromorphone.
86637|NCT02044094|O1|Outcome|Hydromorphone 6 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 6 mg hydromorphone.
86638|NCT02044094|O3|Outcome|Hydromorphone 18 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 18 mg hydromorphone.
86639|NCT02044094|O2|Outcome|Hydromorphone 6 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 6 mg hydromorphone.
86640|NCT02044094|O1|Outcome|Placebo|During hydromorphone challenges, participants received intramuscular (IM) injections of placebo.
86641|NCT02044094|O2|Outcome|Hydromorphone 18 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 18 mg hydromorphone.
86642|NCT02044094|O1|Outcome|Hydromorphone 6 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 6 mg hydromorphone.
86643|NCT02044094|O3|Outcome|Hydromorphone 18 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 18 mg hydromorphone.
86644|NCT02044094|O2|Outcome|Hydromorphone 6 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 6 mg hydromorphone.
86645|NCT02044094|O1|Outcome|Placebo|During hydromorphone challenges, participants received intramuscular (IM) injections of placebo.
86646|NCT02044094|O2|Outcome|Hydromorphone 18 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 18 mg hydromorphone.
86647|NCT02044094|O1|Outcome|Hydromorphone 6 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 6 mg hydromorphone.
86648|NCT02044094|O3|Outcome|Hydromorphone 18 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 18 mg hydromorphone.
86649|NCT02044094|O2|Outcome|Hydromorphone 6 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 6 mg hydromorphone.
86650|NCT02044094|O1|Outcome|Placebo|During hydromorphone challenges, participants received intramuscular (IM) injections of placebo.
86651|NCT02044094|O2|Outcome|Hydromorphone 18 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 18 mg hydromorphone.
86652|NCT02044094|O1|Outcome|Hydromorphone 6 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 6 mg hydromorphone.
86653|NCT02044094|O3|Outcome|Hydromorphone 18 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 18 mg hydromorphone.
86654|NCT02044094|O2|Outcome|Hydromorphone 6 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 6 mg hydromorphone.
86655|NCT02044094|O1|Outcome|Placebo|During hydromorphone challenges, participants received intramuscular (IM) injections of placebo.
86656|NCT02044094|O2|Outcome|Hydromorphone 18 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 18 mg hydromorphone.
86657|NCT02044094|O1|Outcome|Hydromorphone 6 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 6 mg hydromorphone.
86658|NCT02044094|O3|Outcome|Hydromorphone 18 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 18 mg hydromorphone.
86659|NCT02044094|O2|Outcome|Hydromorphone 6 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 6 mg hydromorphone.
86660|NCT02044094|O1|Outcome|Placebo|During hydromorphone challenges, participants received intramuscular (IM) injections of placebo.
86661|NCT02044094|O2|Outcome|Hydromorphone 18 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 18 mg hydromorphone.
86662|NCT02044094|O1|Outcome|Hydromorphone 6 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 6 mg hydromorphone.
86663|NCT02044094|O3|Outcome|Hydromorphone 18 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 18 mg hydromorphone.
86664|NCT02044094|O2|Outcome|Hydromorphone 6 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 6 mg hydromorphone.
86665|NCT02044094|O1|Outcome|Placebo|During hydromorphone challenges, participants received intramuscular (IM) injections of placebo.
86666|NCT02044094|O3|Outcome|Hydromorphone 18 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 18 mg hydromorphone.
86667|NCT02044094|O2|Outcome|Hydromorphone 6 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 6 mg hydromorphone.
86668|NCT02044094|O1|Outcome|Placebo|During hydromorphone challenges, participants received intramuscular (IM) injections of placebo.
86718|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
86669|NCT02044094|O4|Outcome|Hydromorphone 18 mg Challenge|"Participants received three hydromorphone challenges each week, one challenge on each of three consecutive days/week in this 12 week study. Participants and clinical facility staff were blinded to the specific dose of hydromorphone being administered during each challenge.~The hydromorphone 18 mg challenge consisted of an intramuscular injection of 18 mg hydromorphone."
86670|NCT02044094|O3|Outcome|Hydromorphone 6 mg Challenge|"Participants received three hydromorphone challenges each week, one challenge on each of three consecutive days/week in this 12 week study. Participants and clinical facility staff were blinded to the specific dose of hydromorphone being administered during each challenge.~The hydromorphone 6 mg challenge consisted of an intramuscular injection of 6 mg hydromorphone."
86671|NCT02044094|O2|Outcome|Placebo Challenge|"Participants received three hydromorphone challenges each week, one challenge on each of three consecutive days/week in this 12 week study. Participants and clinical facility staff were blinded to the specific dose of hydromorphone being administered during each challenge.~The placebo challenge consisted of an intramuscular injection of placebo (hydromorphone 0mg)."
86672|NCT02044094|O1|Outcome|Depot Buprenorphine|Participants were treated with RBP-6000 300-mg in a single subcutaneous injection on Days 1 and 29.
86673|NCT02044094|O3|Outcome|Hydromorphone 18 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 18 mg hydromorphone.
86674|NCT02044094|O2|Outcome|Hydromorphone 6 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 6 mg hydromorphone.
86675|NCT02044094|O1|Outcome|Placebo|During hydromorphone challenges, participants received intramuscular (IM) injections of placebo.
86676|NCT02044094|O3|Outcome|Hydromorphone 18 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 18 mg hydromorphone.
86677|NCT02044094|O2|Outcome|Hydromorphone 6 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 6 mg hydromorphone.
86678|NCT02044094|O1|Outcome|Placebo|During hydromorphone challenges, participants received intramuscular (IM) injections of placebo.
86679|NCT02044094|O3|Outcome|Hydromorphone 18 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 18 mg hydromorphone.
86680|NCT02044094|O2|Outcome|Hydromorphone 6 mg|During hydromorphone challenges, participants received intramuscular (IM) injections of 6 mg hydromorphone.
86681|NCT02044094|O1|Outcome|Placebo|During hydromorphone challenges, participants received intramuscular (IM) injections of placebo.
86682|NCT02044094|E4|Reported Event|Hydromorphone 18 mg Challenge|"Participants received three hydromorphone challenges each week, one challenge on each of three consecutive days/week in this 12 week study. Participants and clinical facility staff were blinded to the specific dose of hydromorphone being administered during each challenge.~The hydromorphone 18 mg challenge consisted of an intramuscular injection of 18 mg hydromorphone."
86683|NCT02044094|E3|Reported Event|Hydromorphone 6 mg Challenge|"Participants received three hydromorphone challenges each week, one challenge on each of three consecutive days/week in this 12 week study. Participants and clinical facility staff were blinded to the specific dose of hydromorphone being administered during each challenge.~The hydromorphone 6 mg challenge consisted of an intramuscular injection of 6 mg hydromorphone."
86684|NCT02044094|E2|Reported Event|Placebo Challenge|"Participants received three hydromorphone challenges each week, one challenge on each of three consecutive days/week in this 12 week study. Participants and clinical facility staff were blinded to the specific dose of hydromorphone being administered during each challenge.~The placebo challenge consisted of an intramuscular injection of placebo (hydromorphone 0mg)."
86685|NCT02044094|E1|Reported Event|Depot Buprenorphine|Participants were treated with RBP-6000 300 mg in a single subcutaneous injection on Days 1 and 29.
86686|NCT02043938|B1|Baseline|Healthy Volunteers|Thirty-six healthy volunteers received four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR).
86687|NCT02043938|P1|Participant Flow|Healthy Volunteers|Thirty-six healthy volunteers received four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR).
86688|NCT02043938|O1|Outcome|Healthy Volunteers|Thirty-six healthy volunteers received four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR).
86689|NCT02043938|O1|Outcome|Healthy Volunteers|Thirty-six healthy volunteers received four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR).
86690|NCT02043938|O1|Outcome|Healthy Volunteers|Thirty-six healthy volunteers received four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR).
86691|NCT02043938|O1|Outcome|Healthy Volunteers|Thirty-six healthy volunteers received four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR).
86692|NCT02043938|E4|Reported Event|Healthy Volunteers, Sevoflurane With Remifentanil (SR)|Thirty-six healthy volunteers received four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR).
87183|NCT02040779|B2|Baseline|BDP 80 mcg BAI|40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
86693|NCT02043938|E3|Reported Event|Healthy Volunteers, Propofol With Remifentanil (PR)|Thirty-six healthy volunteers received four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR).
86694|NCT02043938|E2|Reported Event|Healthy Volunteers, Sevoflurane (S)|Thirty-six healthy volunteers received four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR).
86695|NCT02043938|E1|Reported Event|Healthy Volunteers, Propofol (P)|Thirty-six healthy volunteers received four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR).
86696|NCT02043808|B3|Baseline|Total|Total of all reporting groups
86697|NCT02043808|B2|Baseline|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
86698|NCT02043808|B1|Baseline|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
86699|NCT02043808|P2|Participant Flow|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
86700|NCT02043808|P1|Participant Flow|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
86701|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
86702|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
86703|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
86704|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
86705|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
86706|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
86707|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
86708|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
86709|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
86710|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
86711|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
86712|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
86713|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
86714|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
86715|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
86716|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
86717|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
87184|NCT02040779|B1|Baseline|Placebo BAI|Placebo breath-actuated inhaler (BAI) twice daily.
86719|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
86720|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
86721|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
86722|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
86723|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
86724|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
86725|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
86726|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
86727|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
86728|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
86729|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
86730|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
86731|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
86732|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
86733|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
86734|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
86735|NCT02043808|E2|Reported Event|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
86736|NCT02043808|E1|Reported Event|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
86737|NCT02043782|B1|Baseline|All Subjects|Pooled data from all arms.
86738|NCT02043782|P6|Participant Flow|Test - Own - Competitor|"The subjects were randomized into six possible treatment groups:~The order of test products for this group was:~Coloplast test product Own product Competitor soft convex product~Coloplast Test: Newly developed 1-piece convex ostomy product~Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.~Competitor soft convex: A commercially available soft convex product"
86739|NCT02043782|P5|Participant Flow|Own - Competitor - Test|"The subjects were randomized into six possible treatment groups:~The order of test products for this group was:~Own product Competitor soft convex product Coloplast test product~Coloplast Test: Newly developed 1-piece convex ostomy product~Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.~Competitor soft convex: A commercially available soft convex product"
86740|NCT02043782|P4|Participant Flow|Competitor - Test - Own|"The subjects were randomized into six possible treatment groups:~The order of test products for this group was:~Competitor soft convex product Coloplast test product Own product~Coloplast Test: Newly developed 1-piece convex ostomy product~Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.~Competitor soft convex: A commercially available soft convex product"
86765|NCT02043704|O2|Outcome|Saline|"Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86741|NCT02043782|P3|Participant Flow|Own - Test - Competitor|"The subjects were randomized into six possible treatment groups:~The order of test products for this group was:~Own product Coloplast test product Competitor soft convex product~Coloplast Test: Newly developed 1-piece convex ostomy product~Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.~Competitor soft convex: A commercially available soft convex product"
86742|NCT02043782|P2|Participant Flow|Competitor - Own - Test|"The subjects were randomized into six possible treatment groups:~The order of test products for this group was:~Competitor soft convex product Own product Coloplast test product~Coloplast Test: Newly developed 1-piece convex ostomy product~Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.~Competitor soft convex: A commercially available soft convex product"
86743|NCT02043782|P1|Participant Flow|Test - Competitor - Own|"The subjects were randomized into six possible treatment groups:~The order of test products for this group was:~Coloplast test product Competitor soft convex product Own product~Coloplast Test: Newly developed 1-piece convex ostomy product~Own product: The subject's own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.~Competitor soft convex: A commercially available soft convex product"
86744|NCT02043782|O3|Outcome|Competitor Soft Convex|Subjects testing Competitor Soft Convex
86745|NCT02043782|O2|Outcome|Own Product|Subjects testing own product
86746|NCT02043782|O1|Outcome|Coloplast Test Product|Subjects testing Coloplast test product
86747|NCT02043782|E3|Reported Event|Competitor Soft Convex|Adverse events reported by subjects testing Competitor soft convex
86748|NCT02043782|E2|Reported Event|Own Product|Adverse events reported by subjects testing own product
86749|NCT02043782|E1|Reported Event|Coloplast Test Product|Adverse events reported by subjects testing Coloplast test product
86750|NCT02043704|B3|Baseline|Total|Total of all reporting groups
86751|NCT02043704|B2|Baseline|Saline|"Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86752|NCT02043704|B1|Baseline|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86753|NCT02043704|P2|Participant Flow|Saline|"Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86754|NCT02043704|P1|Participant Flow|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86755|NCT02043704|O2|Outcome|Saline|"Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86756|NCT02043704|O1|Outcome|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86757|NCT02043704|O2|Outcome|Saline|"Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86758|NCT02043704|O1|Outcome|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86759|NCT02043704|O2|Outcome|Saline|"Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86760|NCT02043704|O1|Outcome|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86761|NCT02043704|O2|Outcome|Saline|"Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86762|NCT02043704|O1|Outcome|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86763|NCT02043704|O2|Outcome|Saline|"Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86764|NCT02043704|O1|Outcome|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86766|NCT02043704|O1|Outcome|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86767|NCT02043704|O2|Outcome|Saline|"Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86768|NCT02043704|O1|Outcome|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86769|NCT02043704|O2|Outcome|Saline|"Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86770|NCT02043704|O1|Outcome|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86771|NCT02043704|O2|Outcome|Saline|"Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86772|NCT02043704|O1|Outcome|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86773|NCT02043704|O2|Outcome|Saline|"Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86774|NCT02043704|O1|Outcome|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86775|NCT02043704|O2|Outcome|Saline|"Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86776|NCT02043704|O1|Outcome|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86777|NCT02043704|O2|Outcome|Saline|"Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86778|NCT02043704|O1|Outcome|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86779|NCT02043704|O2|Outcome|Saline|"Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86780|NCT02043704|O1|Outcome|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86781|NCT02043704|E2|Reported Event|Saline|"Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86782|NCT02043704|E1|Reported Event|IV Acetaminophen|"Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.~IV Acetaminophen: Details covered in arm description."
86783|NCT02043652|B1|Baseline|Chlorquine and Primaquine|"Patients will receive 3-day treatment with chloroquine and 7-day treatment with primaquine in accordance to treatment guidelines in Brazil for P vivax malaria. All patients will receive the same treatment as there is no comparison arm.~Chloroquine: Patients will receive 3-day treatment with chloroquine in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm.~Primaquine: Patients will receive 7-day treatment with primaquine, in conjunction with chloroquine, in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm."
86784|NCT02043652|P1|Participant Flow|Chloroquine and Primaquine|"Patients will receive 3-day treatment with chloroquine and 7-day treatment with primaquine in accordance to treatment guidelines in Brazil for P vivax malaria. All patients will receive the same treatment as there is no comparison arm.~Chloroquine: Patients will receive 3-day treatment with chloroquine in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm.~Primaquine: Patients will receive 7-day treatment with primaquine, in conjunction with chloroquine, in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm."
86861|NCT02043366|O5|Outcome|Butorphanol-Flurbiprofen Axetil|A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil
88431|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
86785|NCT02043652|O1|Outcome|Chlorquine and Primaquine|"Patients will receive 3-day treatment with chloroquine and 7-day treatment with primaquine in accordance to treatment guidelines in Brazil for P vivax malaria. All patients will receive the same treatment as there is no comparison arm.~Chloroquine: Patients will receive 3-day treatment with chloroquine in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm.~Primaquine: Patients will receive 7-day treatment with primaquine, in conjunction with chloroquine, in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm."
86786|NCT02043652|O1|Outcome|Chlorquine and Primaquine|"Patients will receive 3-day treatment with chloroquine and 7-day treatment with primaquine in accordance to treatment guidelines in Brazil for P vivax malaria. All patients will receive the same treatment as there is no comparison arm.~Chloroquine: Patients will receive 3-day treatment with chloroquine in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm.~Primaquine: Patients will receive 7-day treatment with primaquine, in conjunction with chloroquine, in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm."
86787|NCT02043652|E1|Reported Event|Chlorquine and Primaquine|"Patients will receive 3-day treatment with chloroquine and 7-day treatment with primaquine in accordance to treatment guidelines in Brazil for P vivax malaria. All patients will receive the same treatment as there is no comparison arm.~Chloroquine: Patients will receive 3-day treatment with chloroquine in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm.~Primaquine: Patients will receive 7-day treatment with primaquine, in conjunction with chloroquine, in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm."
86788|NCT02043379|B3|Baseline|Total|Total of all reporting groups
86789|NCT02043379|B2|Baseline|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86790|NCT02043379|B1|Baseline|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86791|NCT02043379|P2|Participant Flow|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86792|NCT02043379|P1|Participant Flow|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86793|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86794|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86795|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86796|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86797|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86798|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86799|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86800|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86862|NCT02043366|O4|Outcome|Butorphanol|Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil
88432|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
86801|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86802|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86803|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86804|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86805|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86806|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86807|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86808|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86809|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86810|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86811|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86812|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86813|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86814|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86815|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86816|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86817|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86818|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86819|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86820|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86821|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86822|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86823|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86824|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86825|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86826|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86827|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86828|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86829|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86830|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86831|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86832|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86833|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86834|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86835|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86836|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86837|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86838|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86839|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86840|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86841|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86842|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86843|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86844|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86845|NCT02043379|E2|Reported Event|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
86846|NCT02043379|E1|Reported Event|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
86847|NCT02043366|B7|Baseline|Total|Total of all reporting groups
86848|NCT02043366|B6|Baseline|Sufentanil|Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil.
86849|NCT02043366|B5|Baseline|Butorphanol-Flurbiprofen Axetil|A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil.
86850|NCT02043366|B4|Baseline|Butorphanol|Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil.
86851|NCT02043366|B3|Baseline|Flurbiprofen AxetilⅡ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
86852|NCT02043366|B2|Baseline|Flurbiprofen AxetilⅠ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
86853|NCT02043366|B1|Baseline|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil~Normal Saline"
86854|NCT02043366|P6|Participant Flow|Sufentanil|Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil.
86855|NCT02043366|P5|Participant Flow|Butorphanol-Flurbiprofen Axetil|A dose of 10μg/kg butorphanol and a dose of 0.5mg/kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil.
86856|NCT02043366|P4|Participant Flow|Butorphanol|Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil.
86857|NCT02043366|P3|Participant Flow|Flurbiprofen AxetilⅡ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
86858|NCT02043366|P2|Participant Flow|Flurbiprofen AxetilⅠ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
86859|NCT02043366|P1|Participant Flow|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil~Normal Saline"
86860|NCT02043366|O6|Outcome|Sufentanil|Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil
88433|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
86863|NCT02043366|O3|Outcome|Flurbiprofen AxetilⅡ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
86864|NCT02043366|O2|Outcome|Flurbiprofen AxetilⅠ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
86865|NCT02043366|O1|Outcome|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil~Normal Saline"
86866|NCT02043366|O6|Outcome|Sufentanil|Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil
86867|NCT02043366|O5|Outcome|Butorphanol-Flurbiprofen Axetil|A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil.
86868|NCT02043366|O4|Outcome|Butorphanol|Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil.
86869|NCT02043366|O3|Outcome|Flurbiprofen AxetilⅡ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
86870|NCT02043366|O2|Outcome|Flurbiprofen AxetilⅠ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
86871|NCT02043366|O1|Outcome|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil~Normal Saline"
86872|NCT02043366|E6|Reported Event|Sufentanil|Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil
86873|NCT02043366|E5|Reported Event|Butorphanol-Flurbiprofen Axetil|A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentani
86874|NCT02043366|E4|Reported Event|Butorphanol|Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentani
86875|NCT02043366|E3|Reported Event|Flurbiprofen AxetilⅡ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
86876|NCT02043366|E2|Reported Event|Flurbiprofen AxetilⅠ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
86877|NCT02043366|E1|Reported Event|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil~Normal Saline"
86878|NCT02043145|B4|Baseline|Total|Total of all reporting groups
86879|NCT02043145|B3|Baseline|Glabellar Lines|Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
86880|NCT02043145|B2|Baseline|Focal Spasticity|Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
86881|NCT02043145|B1|Baseline|Axillary Hyperhidrosis|Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
86882|NCT02043145|P3|Participant Flow|Glabellar Lines|Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
86883|NCT02043145|P2|Participant Flow|Focal Spasticity|Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
86884|NCT02043145|P1|Participant Flow|Axillary Hyperhidrosis|Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
86885|NCT02043145|O1|Outcome|Glabellar Lines|Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
86886|NCT02043145|O1|Outcome|Focal Spasticity|Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
86887|NCT02043145|O1|Outcome|Axillary Hyperhidrosis|Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
86888|NCT02043145|O3|Outcome|Glabellar Lines|Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
86889|NCT02043145|O2|Outcome|Focal Spasticity|Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
86890|NCT02043145|O1|Outcome|Axillary Hyperhidrosis|Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
86891|NCT02043145|E3|Reported Event|Glabellar Lines|Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
86892|NCT02043145|E2|Reported Event|Focal Spasticity|Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
86893|NCT02043145|E1|Reported Event|Axillary Hyperhidrosis|Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
86894|NCT02043132|B3|Baseline|Total|Total of all reporting groups
87185|NCT02040779|P3|Participant Flow|BDP 160 mcg BAI|80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
86895|NCT02043132|B2|Baseline|Normal Saline|"Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
86896|NCT02043132|B1|Baseline|Tranexamic Acid|"Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
86897|NCT02043132|P2|Participant Flow|Normal Saline|"Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
86898|NCT02043132|P1|Participant Flow|Tranexamic Acid|"Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
86899|NCT02043132|O2|Outcome|Normal Saline|"Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
86900|NCT02043132|O1|Outcome|Tranexamic Acid|"Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
86901|NCT02043132|O2|Outcome|Normal Saline|"Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
86902|NCT02043132|O1|Outcome|Tranexamic Acid|"Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
86903|NCT02043132|O2|Outcome|Normal Saline|"Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
87059|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
86904|NCT02043132|O1|Outcome|Tranexamic Acid|"Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
86905|NCT02043132|O2|Outcome|Normal Saline|"Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
86906|NCT02043132|O1|Outcome|Tranexamic Acid|"Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
86907|NCT02043132|O2|Outcome|Normal Saline|"Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
86908|NCT02043132|O1|Outcome|Tranexamic Acid|"Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
86909|NCT02043132|O2|Outcome|Normal Saline|"Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
86910|NCT02043132|O1|Outcome|Tranexamic Acid|"Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
86911|NCT02043132|O2|Outcome|Normal Saline|"Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
86912|NCT02043132|O1|Outcome|Tranexamic Acid|"Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
87099|NCT02041286|B1|Baseline|Intended Users of the Monitoring System|Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
87186|NCT02040779|P2|Participant Flow|BDP 80 mcg BAI|40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
86913|NCT02043132|O2|Outcome|Normal Saline|"Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
86914|NCT02043132|O1|Outcome|Tranexamic Acid|"Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
86915|NCT02043132|E2|Reported Event|Normal Saline|"Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
86916|NCT02043132|E1|Reported Event|Tranexamic Acid|"Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
86917|NCT02043015|B1|Baseline|Recipients of HIV Prevention Services|Study participants receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV testing, risk-reduction counseling, linkage to care, and pre-exposure prophylaxis with FTC/TDF.
86918|NCT02043015|P1|Participant Flow|Recipients of HIV Prevention Services|Study participants receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), men who have sex with men (MSM) and lesbian, gay, bisexual, and transgender (LGBT) sensitization training for staff and providers, HIV testing, risk-reduction counseling, linkage to care, and pre-exposure prophylaxis with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).
86919|NCT02043015|O1|Outcome|Health Care Providers|Health care providers in Cape Town who care for MSM populations.
86920|NCT02043015|O1|Outcome|Recipients of HIV Prevention Services|Study participants receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV testing, risk-reduction counseling, linkage to care, and pre-exposure prophylaxis with FTC/TDF.
86921|NCT02043015|O1|Outcome|Recipients of HIV Prevention Services|Study participants receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV testing, risk-reduction counseling, linkage to care, and pre-exposure prophylaxis with FTC/TDF.
86922|NCT02043015|O1|Outcome|Recipients of HIV Prevention Services|Study participants receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV testing, risk-reduction counseling, linkage to care, and pre-exposure prophylaxis with FTC/TDF.
86923|NCT02043015|O1|Outcome|Recipients of HIV Prevention Services|Study participants receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV testing, risk-reduction counseling, linkage to care, and pre-exposure prophylaxis with FTC/TDF.
86924|NCT02043015|O1|Outcome|Recipients of HIV Prevention Services|Study participants receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV testing, risk-reduction counseling, linkage to care, and pre-exposure prophylaxis with FTC/TDF.
86925|NCT02043015|O1|Outcome|Recipients of HIV Prevention Services|Study participants receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV testing, risk-reduction counseling, linkage to care, and pre-exposure prophylaxis with FTC/TDF.
86926|NCT02043015|O1|Outcome|Recipients of HIV Prevention Services|Study participants receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV testing, risk-reduction counseling, linkage to care, and pre-exposure prophylaxis with FTC/TDF.
87152|NCT02040844|O2|Outcome|Cat-PAD Treatment (2 Courses)|Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks
87153|NCT02040844|O1|Outcome|Cat-PAD Treatment 1 (1 Course)|Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks
87154|NCT02040844|O3|Outcome|Placebo|Placebo - 1 dose every 4 weeks
86927|NCT02043015|O1|Outcome|Recipients of HIV Prevention Services|Study participants receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV testing, risk-reduction counseling, linkage to care, and pre-exposure prophylaxis with FTC/TDF.
86928|NCT02043015|O1|Outcome|Recipients of HIV Prevention Services|Men receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV testing, risk-reduction counseling, linkage to care, and Pre-exposure prophylaxis with FTC/TDF
86929|NCT02043015|E1|Reported Event|Recipients of HIV Prevention Services|Study participants receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV Testing, risk-reduction counseling, linkage to care, and pre-exposure prophylaxis with FTC/TDF.
86930|NCT02042924|B1|Baseline|Imaging Studies|"Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.~FLT PET/CT: Functional marrow imaging using the FLT PET/CT will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).~MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days)."
86931|NCT02042924|P1|Participant Flow|Imaging Studies|"Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.~FLT PET/CT: Functional marrow imaging using the FLT PET/CT will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).~MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days)."
86932|NCT02042924|O1|Outcome|Imaging Studies|"Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.~FLT PET/CT: Functional marrow imaging using the FLT PET/CT will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).~MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days)."
86933|NCT02042924|O1|Outcome|Imaging Studies|"Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.~FLT PET/CT: Functional marrow imaging using the FLT PET/CT will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).~MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days)."
86934|NCT02042924|O1|Outcome|Imaging Studies|"Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.~FLT PET/CT: Functional marrow imaging using the FLT PET/CT will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).~MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days)."
86935|NCT02042924|E1|Reported Event|Imaging Studies|"Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.~FLT PET/CT: Functional marrow imaging using the FLT PET/CT will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).~MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days)."
86936|NCT02042911|B1|Baseline|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
86937|NCT02042911|P1|Participant Flow|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
86938|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
86939|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
86940|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
86941|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
86942|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
86943|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
86944|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
86945|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
86946|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
86947|NCT02042911|E1|Reported Event|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
86948|NCT02042872|B3|Baseline|Total|Total of all reporting groups
86949|NCT02042872|B2|Baseline|No Treatment|Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
86950|NCT02042872|B1|Baseline|Zoledronic Acid|At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
86951|NCT02042872|P2|Participant Flow|No Treatment|Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
86952|NCT02042872|P1|Participant Flow|Zoledronic Acid|At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
86953|NCT02042872|O2|Outcome|No Treatment|Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
86954|NCT02042872|O1|Outcome|Zoledronic Acid|At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
86955|NCT02042872|O2|Outcome|No Treatment|Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
86956|NCT02042872|O1|Outcome|Zoledronic Acid|At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
86957|NCT02042872|E2|Reported Event|No Treatment|Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
86958|NCT02042872|E1|Reported Event|Zoledronic Acid|At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
86959|NCT02042534|B3|Baseline|Total|Total of all reporting groups
86960|NCT02042534|B2|Baseline|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
86961|NCT02042534|B1|Baseline|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
86962|NCT02042534|P2|Participant Flow|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
86963|NCT02042534|P1|Participant Flow|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
87155|NCT02040844|O2|Outcome|Cat-PAD Treatment (2 Courses)|Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks
87156|NCT02040844|O1|Outcome|Cat-PAD Treatment 1 (1 Course)|Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks
86964|NCT02042534|O2|Outcome|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
86965|NCT02042534|O1|Outcome|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
86966|NCT02042534|O2|Outcome|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
86967|NCT02042534|O1|Outcome|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
86968|NCT02042534|O2|Outcome|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
86969|NCT02042534|O1|Outcome|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
86970|NCT02042534|O2|Outcome|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
86971|NCT02042534|O1|Outcome|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
86972|NCT02042534|O2|Outcome|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
86973|NCT02042534|O1|Outcome|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
86974|NCT02042534|E2|Reported Event|Warfarin|"Safety population : 90 (patients)~Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
86975|NCT02042534|E1|Reported Event|Rivaroxaban|"Safety population : 98 (patients)~Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
86976|NCT02042443|B3|Baseline|Total|Total of all reporting groups
86977|NCT02042443|B2|Baseline|Chemotherapy|Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
86978|NCT02042443|B1|Baseline|Trametinib|Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
86979|NCT02042443|P2|Participant Flow|Chemotherapy|Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
86980|NCT02042443|P1|Participant Flow|Trametinib|Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
86981|NCT02042443|O2|Outcome|Chemotherapy|Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
86982|NCT02042443|O1|Outcome|Trametinib|Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
86983|NCT02042443|O2|Outcome|Chemotherapy|Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
86984|NCT02042443|O1|Outcome|Trametinib|Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
86985|NCT02042443|O2|Outcome|Chemotherapy|Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
86986|NCT02042443|O1|Outcome|Trametinib|Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
86987|NCT02042443|O2|Outcome|Chemotherapy|Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
86988|NCT02042443|O1|Outcome|Trametinib|Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
86989|NCT02042443|E2|Reported Event|Chemotherapy|Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
86990|NCT02042443|E1|Reported Event|Trametinib|Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
86991|NCT02042404|B1|Baseline|Mild to Severe Hearing Impairment|Subjects wearing the Earlens System in their daily lives.
86992|NCT02042404|P2|Participant Flow|Roll-in Cohort: Mild to Severe Hearing Impairment|Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
86993|NCT02042404|P1|Participant Flow|Primary Cohort: Mild to Severe Hearing Impairment|"Sound amplification provided via the EarLens System assistive hearing device.~Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time."
86994|NCT02042404|O1|Outcome|Mild to Severe Hearing Impairment|"Sound amplification provided via the EarLens System assistive hearing device.~Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time."
86995|NCT02042404|O2|Outcome|Roll-in Cohort: Mild to Severe Hearing Impairment|Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
86996|NCT02042404|O1|Outcome|Primary Cohort: Mild to Severe Hearing Impairment|"Sound amplification provided via the EarLens System assistive hearing device.~Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time."
86997|NCT02042404|O2|Outcome|Roll-in Cohort: Mild to Severe Hearing Impairment|Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
87157|NCT02040844|E3|Reported Event|Placebo|Placebo - 1 dose every 4 weeks
86998|NCT02042404|O1|Outcome|Primary Cohort: Mild to Severe Hearing Impairment|"Sound amplification provided via the EarLens System assistive hearing device.~Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time."
86999|NCT02042404|O1|Outcome|Mild to Severe Hearing Impairment|Both Primary Cohort and Roll-in Cohorts are combined for safety analysis.
87000|NCT02042404|O2|Outcome|Roll-in Cohort: Mild to Severe Hearing Impairment|Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
87001|NCT02042404|O1|Outcome|Primary Cohort: Mild to Severe Hearing Impairment|"Sound amplification provided via the EarLens System assistive hearing device.~Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time."
87002|NCT02042404|E1|Reported Event|Mild to Severe Hearing Impairment|Both Primary Cohort and Roll-in Cohorts are combined for safety analysis.
87003|NCT02042274|B1|Baseline|Fish Oil|Fish oil supplements providing up to 3g per day of EPA and DHA, for 90 days.
87004|NCT02042274|P1|Participant Flow|Fish Oil Supplement|"Fish oil supplements providing up to 3g per day of EPA and DHA~Fish oil supplement: Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period.~Measurements are made at three time points: Baseline (Day 0 - before beginning fish oil supplementation), 3 months (Day 90 - after fish oil supplementation), and 5 months (Day 150 - 2 month washout)."
87005|NCT02042274|O1|Outcome|Fish Oil Supplement|"Fish oil supplements providing up to 3g per day of EPA and DHA~Fish oil supplement: Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period."
87006|NCT02042274|O1|Outcome|Fish Oil Supplement|"Fish oil supplements providing up to 3g per day of EPA and DHA~Fish oil supplement: Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period."
87007|NCT02042274|E1|Reported Event|Fish Oil Supplement|"Fish oil supplements providing up to 3g per day of EPA and DHA~Fish oil supplement: Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period."
87008|NCT02042131|B4|Baseline|Total|Total of all reporting groups
87009|NCT02042131|B3|Baseline|Enhanced Crisis Response Plan (E-CRP)|"The E-CRP includes the following intervention components:~suicide risk assessment~supportive listening~identify personal warning signs~identify self-management skills~identify reasons for living~identify social support contacts~provision of professional and crisis contact information~referral to mental health treatment and community resources~Treatment As Usual (TAU)~Crisis Response Plan (CRP)~Enhanced Crisis Response Plan (E-CRP)"
87010|NCT02042131|B2|Baseline|Standard Crisis Response Plan (S-CRP)|"CRP includes the following intervention components:~suicide risk assessment~supportive listening~identify personal warning signs~identify self-management skills~identify social support contacts~provision of professional and crisis contact information~referral to mental health treatment and community resources~Treatment As Usual (TAU)~Crisis Response Plan (CRP)"
87011|NCT02042131|B1|Baseline|Treatment As Usual (TAU)|"TAU includes the following intervention components:~suicide risk assessment~supportive listening~provision of professional and crisis contact information~referral to mental health treatment and community resources~verbal contract for safety~Treatment As Usual (TAU)"
87012|NCT02042131|P3|Participant Flow|Enhanced Crisis Response Plan (E-CRP)|"The E-CRP includes the following intervention components:~suicide risk assessment~supportive listening~identify personal warning signs~identify self-management skills~identify reasons for living~identify social support contacts~provision of professional and crisis contact information~referral to mental health treatment and community resources~Treatment As Usual (TAU)~Crisis Response Plan (CRP)~Enhanced Crisis Response Plan (E-CRP)"
87013|NCT02042131|P2|Participant Flow|Standard Crisis Response Plan (S-CRP)|"CRP includes the following intervention components:~suicide risk assessment~supportive listening~identify personal warning signs~identify self-management skills~identify social support contacts~provision of professional and crisis contact information~referral to mental health treatment and community resources~Treatment As Usual (TAU)~Crisis Response Plan (CRP)"
87014|NCT02042131|P1|Participant Flow|Treatment As Usual (TAU)|"TAU includes the following intervention components:~suicide risk assessment~supportive listening~provision of professional and crisis contact information~referral to mental health treatment and community resources~verbal contract for safety~Treatment As Usual (TAU)"
87015|NCT02042131|O3|Outcome|Enhanced Crisis Response Plan (E-CRP)|"The E-CRP includes the following intervention components:~suicide risk assessment~supportive listening~identify personal warning signs~identify self-management skills~identify reasons for living~identify social support contacts~provision of professional and crisis contact information~referral to mental health treatment and community resources~Enhanced Crisis Response Plan (E-CRP)"
87016|NCT02042131|O2|Outcome|Standard Crisis Response Plan (S-CRP)|"CRP includes the following intervention components:~suicide risk assessment~supportive listening~identify personal warning signs~identify self-management skills~identify social support contacts~provision of professional and crisis contact information~referral to mental health treatment and community resources~Standard Crisis Response Plan (S-CRP)~Enhanced Crisis Response Plan (E-CRP)"
87017|NCT02042131|O1|Outcome|Treatment As Usual (TAU)|"TAU includes the following intervention components:~suicide risk assessment~supportive listening~provision of professional and crisis contact information~referral to mental health treatment and community resources~verbal contract for safety~Treatment As Usual (TAU)"
87158|NCT02040844|E2|Reported Event|Cat-PAD Treatment (2 Courses)|Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks
87018|NCT02042131|O3|Outcome|Enhanced Crisis Response Plan (E-CRP)|"The E-CRP includes the following intervention components:~suicide risk assessment~supportive listening~identify personal warning signs~identify self-management skills~identify reasons for living~identify social support contacts~provision of professional and crisis contact information~referral to mental health treatment and community resources~Treatment As Usual (TAU)~Crisis Response Plan (S-CRP)~Enhanced Crisis Response Plan (E-CRP)"
87019|NCT02042131|O2|Outcome|Standard Crisis Response Plan (S-CRP)|"CRP includes the following intervention components:~suicide risk assessment~supportive listening~identify personal warning signs~identify self-management skills~identify social support contacts~provision of professional and crisis contact information~referral to mental health treatment and community resources~Treatment As Usual (TAU)~Crisis Response Plan (S-CRP)"
87020|NCT02042131|O1|Outcome|Treatment As Usual (TAU)|"TAU includes the following intervention components:~suicide risk assessment~supportive listening~provision of professional and crisis contact information~referral to mental health treatment and community resources~verbal contract for safety~Treatment As Usual (TAU)"
87021|NCT02042131|O3|Outcome|Enhanced Crisis Response Plan (E-CRP)|"The E-CRP includes the following intervention components:~suicide risk assessment~supportive listening~identify personal warning signs~identify self-management skills~identify reasons for living~identify social support contacts~provision of professional and crisis contact information~referral to mental health treatment and community resources~Treatment As Usual (TAU)~Crisis Response Plan (S-CRP)~Enhanced Crisis Response Plan (E-CRP)"
87022|NCT02042131|O2|Outcome|Standard Crisis Response Plan (S-CRP)|"CRP includes the following intervention components:~suicide risk assessment~supportive listening~identify personal warning signs~identify self-management skills~identify social support contacts~provision of professional and crisis contact information~referral to mental health treatment and community resources~Treatment As Usual (TAU)~Crisis Response Plan (S-CRP)"
87023|NCT02042131|O1|Outcome|Treatment As Usual (TAU)|"TAU includes the following intervention components:~suicide risk assessment~supportive listening~provision of professional and crisis contact information~referral to mental health treatment and community resources~verbal contract for safety~Treatment As Usual (TAU)"
87024|NCT02042131|O3|Outcome|Enhanced Crisis Response Plan (E-CRP)|"The E-CRP includes the following intervention components:~suicide risk assessment~supportive listening~identify personal warning signs~identify self-management skills~identify reasons for living~identify social support contacts~provision of professional and crisis contact information~referral to mental health treatment and community resources~Enhanced Crisis Response Plan (E-CRP)"
87025|NCT02042131|O2|Outcome|Standard Crisis Response Plan (S-CRP)|"CRP includes the following intervention components:~suicide risk assessment~supportive listening~identify personal warning signs~identify self-management skills~identify social support contacts~provision of professional and crisis contact information~referral to mental health treatment and community resources~Standard Crisis Response Plan (S-CRP)~Enhanced Crisis Response Plan (E-CRP)"
87026|NCT02042131|O1|Outcome|Treatment As Usual (TAU)|"TAU includes the following intervention components:~suicide risk assessment~supportive listening~provision of professional and crisis contact information~referral to mental health treatment and community resources~verbal contract for safety~Treatment As Usual (TAU)"
87027|NCT02042131|E3|Reported Event|Enhanced Crisis Response Plan (E-CRP)|"The E-CRP includes the following intervention components:~suicide risk assessment~supportive listening~identify personal warning signs~identify self-management skills~identify reasons for living~identify social support contacts~provision of professional and crisis contact information~referral to mental health treatment and community resources~Treatment As Usual (TAU)~Crisis Response Plan (CRP)~Enhanced Crisis Response Plan (E-CRP)"
87028|NCT02042131|E2|Reported Event|Standard Crisis Response Plan (S-CRP)|"CRP includes the following intervention components:~suicide risk assessment~supportive listening~identify personal warning signs~identify self-management skills~identify social support contacts~provision of professional and crisis contact information~referral to mental health treatment and community resources~Treatment As Usual (TAU)~Crisis Response Plan (CRP)"
87029|NCT02042131|E1|Reported Event|Treatment As Usual (TAU)|"TAU includes the following intervention components:~suicide risk assessment~supportive listening~provision of professional and crisis contact information~referral to mental health treatment and community resources~verbal contract for safety~Treatment As Usual (TAU)"
87030|NCT02041533|B3|Baseline|Total|Total of all reporting groups
87031|NCT02041533|B2|Baseline|Investigator Choice of Chemotherapy|"Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:~Squamous:~gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or~gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or~paclitaxel (200 mg/m2) with carboplatin (AUC 6)~Non-Squamous:~pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or~pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total)."
87032|NCT02041533|B1|Baseline|Nivolumab|Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
87033|NCT02041533|P2|Participant Flow|Investigator Choice of Chemotherapy|"Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:~Squamous:~gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or~gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or~paclitaxel (200 mg/m2) with carboplatin (AUC 6)~Non-Squamous:~pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or~pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total)."
87034|NCT02041533|P1|Participant Flow|Nivolumab|Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
87035|NCT02041533|O2|Outcome|Investigator Choice of Chemotherapy|"Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:~Squamous:~gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or~gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or~paclitaxel (200 mg/m2) with carboplatin (AUC 6)~Non-Squamous:~pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or~pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total)."
87036|NCT02041533|O1|Outcome|Nivolumab|Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
87159|NCT02040844|E1|Reported Event|Cat-PAD Treatment 1 (1 Course)|Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks
87037|NCT02041533|O2|Outcome|Investigator Choice of Chemotherapy|"Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:~Squamous:~gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or~gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or~paclitaxel (200 mg/m2) with carboplatin (AUC 6)~Non-Squamous:~pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or~pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total)."
87038|NCT02041533|O1|Outcome|Nivolumab|Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
87039|NCT02041533|O2|Outcome|Investigator Choice of Chemotherapy|"Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:~Squamous:~gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or~gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or~paclitaxel (200 mg/m2) with carboplatin (AUC 6)~Non-Squamous:~pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or~pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total)."
87040|NCT02041533|O1|Outcome|Nivolumab|Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
87041|NCT02041533|O2|Outcome|Investigator Choice of Chemotherapy|"Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:~Squamous:~gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or~gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or~paclitaxel (200 mg/m2) with carboplatin (AUC 6)~Non-Squamous:~pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or~pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total)."
87042|NCT02041533|O1|Outcome|Nivolumab|Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
87043|NCT02041533|O2|Outcome|Investigator Choice of Chemotherapy|"Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:~Squamous:~gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or~gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or~paclitaxel (200 mg/m2) with carboplatin (AUC 6)~Non-Squamous:~pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or~pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total)."
87044|NCT02041533|O1|Outcome|Nivolumab|Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
87045|NCT02041533|O2|Outcome|Investigator Choice of Chemotherapy|"Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:~Squamous:~gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or~gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or~paclitaxel (200 mg/m2) with carboplatin (AUC 6)~Non-Squamous:~pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or~pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total)."
87046|NCT02041533|O1|Outcome|Nivolumab|Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
87047|NCT02041533|O2|Outcome|Investigator Choice of Chemotherapy|"Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:~Squamous:~gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or~gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or~paclitaxel (200 mg/m2) with carboplatin (AUC 6)~Non-Squamous:~pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or~pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total)."
87048|NCT02041533|O1|Outcome|Nivolumab|Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
87049|NCT02041533|O2|Outcome|Investigator Choice of Chemotherapy|"Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:~Squamous:~gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or~gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or~paclitaxel (200 mg/m2) with carboplatin (AUC 6)~Non-Squamous:~pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or~pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total)."
87050|NCT02041533|O1|Outcome|Nivolumab|Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
87051|NCT02041533|E2|Reported Event|INVESTIGATOR CHOICE|
87052|NCT02041533|E1|Reported Event|NIVOLUMAB 3 mg/kg|
87053|NCT02041520|B3|Baseline|Total|Total of all reporting groups
87054|NCT02041520|B2|Baseline|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
87055|NCT02041520|B1|Baseline|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
87056|NCT02041520|P2|Participant Flow|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
87057|NCT02041520|P1|Participant Flow|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
87058|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
87160|NCT02040792|B6|Baseline|Total|Total of all reporting groups
87161|NCT02040792|B5|Baseline|350 mcg|"TD-4208~TD-4208"
87162|NCT02040792|B4|Baseline|175 mcg|"TD-4208~TD-4208"
87060|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
87061|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
87062|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
87063|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
87064|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
87065|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
87066|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
87067|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
87068|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
87069|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
87070|NCT02041520|O2|Outcome|Placebo|Patiemts who received placebo for 6 months
87071|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|Patients who received omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and 2 in the night...
87072|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
87073|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
87074|NCT02041520|E2|Reported Event|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
87075|NCT02041520|E1|Reported Event|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
87076|NCT02041377|B1|Baseline|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
87077|NCT02041377|P1|Participant Flow|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
87163|NCT02040792|B3|Baseline|88 mcg|"TD-4208~TD-4208"
87164|NCT02040792|B2|Baseline|44 mcg|"TD-4208~TD-4208"
87165|NCT02040792|B1|Baseline|Placebo|"Placebo~Placebo"
87166|NCT02040792|P5|Participant Flow|350 mcg|"TD-4208~TD-4208"
87078|NCT02041377|O1|Outcome|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
87079|NCT02041377|O1|Outcome|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
87080|NCT02041377|O1|Outcome|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
87081|NCT02041377|O1|Outcome|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
87082|NCT02041377|O1|Outcome|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
87083|NCT02041377|E1|Reported Event|Intended Users of the Monitoring System|"Subjects with diabetes use the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results are compared to reference method results obtained from subject capillary plasma. Also, study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma."
87084|NCT02041325|B3|Baseline|Total|Total of all reporting groups
87085|NCT02041325|B2|Baseline|Placebo|Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
87086|NCT02041325|B1|Baseline|Lenalidomide|Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
87087|NCT02041325|P2|Participant Flow|Placebo|Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
87088|NCT02041325|P1|Participant Flow|Lenalidomide|Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
87089|NCT02041325|O2|Outcome|Placebo|Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
87090|NCT02041325|O1|Outcome|Lenalidomide|Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
87091|NCT02041325|O2|Outcome|Placebo|"Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.~Placebo: Subjects will receive placebo for 7 days prior to and 7 days after the vaccine."
87092|NCT02041325|O1|Outcome|Lenalidomide|"Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.~Lenalidomide: Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine."
87093|NCT02041325|O2|Outcome|Placebo|Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
87094|NCT02041325|O1|Outcome|Lenalidomide|Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
87095|NCT02041325|O2|Outcome|Placebo|"Placebo will be administered for 7 days prior to and 7 days after the vaccine.~Placebo: Placebo will be administered for 7 days prior to and 7 days after the vaccine."
87096|NCT02041325|O1|Outcome|Lenalidomide|"Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd or placebo for 2 weeks.~Lenalidomide: Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd or placebo for 2 weeks."
87097|NCT02041325|E2|Reported Event|Placebo|Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
87098|NCT02041325|E1|Reported Event|Lenalidomide|Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
87167|NCT02040792|P4|Participant Flow|175 mcg|"TD-4208~TD-4208"
87100|NCT02041286|P1|Participant Flow|Intended Users of the Monitoring System|"Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi Contour Investigational BG Monitoring System: Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi Contour Investigational BG Monitoring System with no training. All BG results are compared to reference method results obtained from subject capillary plasma. Also, study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma."
87101|NCT02041286|O1|Outcome|Intended Users of the Monitoring System|Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
87102|NCT02041286|O1|Outcome|Intended Users of the Monitoring System|Study staff test subject capillary blood and BG results are compared to reference method results obtained from subject capillary plasma.
87103|NCT02041286|O1|Outcome|Intended Users of the Monitoring System|Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
87104|NCT02041286|O1|Outcome|Intended Users of the Monitoring System|Study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma.
87105|NCT02041286|O1|Outcome|Intended Users of the Monitoring System|Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
87106|NCT02041286|E1|Reported Event|Intended Users of the Monitoring System|"Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi Contour Investigational BG Monitoring System: Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi Contour Investigational BG Monitoring System with no training. All BG results are compared to reference method results obtained from subject capillary plasma. Also, study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma."
87107|NCT02041221|B7|Baseline|Total|Total of all reporting groups
87108|NCT02041221|B6|Baseline|Placebo|
87109|NCT02041221|B5|Baseline|S0597 Dose 5|
87110|NCT02041221|B4|Baseline|S0597 Dose 4|
87111|NCT02041221|B3|Baseline|S0597 Dose 3|
87112|NCT02041221|B2|Baseline|S0597 Dose 2|"The subjects will receive placebo.~S0597: The subjects will receive S0597.~Placebo"
87113|NCT02041221|B1|Baseline|S0597 Dose 1|"Subjects will be administered with S0597~S0597: The subjects will receive S0597.~Placebo"
87114|NCT02041221|P6|Participant Flow|Placebo|Subjects will receive placebo
87115|NCT02041221|P5|Participant Flow|S0597 Dose 5|Subjects will receive SPARC1316 dose 5
87116|NCT02041221|P4|Participant Flow|S0597 Dose 4|Subjects will receive SPARC1316 dose 4
87117|NCT02041221|P3|Participant Flow|S0597 Dose 3|Subjects will receive SPARC1316 dose 3
87118|NCT02041221|P2|Participant Flow|S0597 Dose 2|Subjects will receive SPARC1316 dose 2
87119|NCT02041221|P1|Participant Flow|S0597 Dose 1|Subjects will be administered with SPARC1316 dose 1
87120|NCT02041221|O6|Outcome|Placebo|
87121|NCT02041221|O5|Outcome|S0597 Dose 5|
87122|NCT02041221|O4|Outcome|S0597 Dose 4|
87123|NCT02041221|O3|Outcome|S0597 Dose 3|
87124|NCT02041221|O2|Outcome|S0597 Dose 2|
87125|NCT02041221|O1|Outcome|S0597 Dose 1|"The subjects will receive placebo.~S0597: The subjects will receive S0597.~Placebo"
87126|NCT02041221|E6|Reported Event|Placebo|
87127|NCT02041221|E5|Reported Event|S0597 Dose 5|
87128|NCT02041221|E4|Reported Event|S0597 Dose 4|
87129|NCT02041221|E3|Reported Event|S0597 Dose 3|
87130|NCT02041221|E2|Reported Event|S0597 Dose 2|"The subjects will receive placebo.~S0597: The subjects will receive S0597.~Placebo"
87131|NCT02041221|E1|Reported Event|S0597 Dose 1|"Subjects will be administered with S0597~S0597: The subjects will receive S0597.~Placebo"
87132|NCT02040844|B4|Baseline|Total|Total of all reporting groups
87133|NCT02040844|B3|Baseline|Placebo|Placebo - 1 dose every 4 weeks
87134|NCT02040844|B2|Baseline|Cat-PAD Treatment (2 Courses)|Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks
87135|NCT02040844|B1|Baseline|Cat-PAD Treatment 1 (1 Course)|Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks
87136|NCT02040844|P3|Participant Flow|Placebo|Placebo - 1 dose every 4 weeks
87137|NCT02040844|P2|Participant Flow|Cat-PAD Treatment (2 Courses)|Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks
87138|NCT02040844|P1|Participant Flow|Cat-PAD Treatment 1 (1 Course)|Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks
87139|NCT02040844|O3|Outcome|Placebo|Placebo - 1 dose every 4 weeks
87140|NCT02040844|O2|Outcome|Cat-PAD Treatment (2 Courses)|Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks
87141|NCT02040844|O1|Outcome|Cat-PAD Treatment 1 (1 Course)|Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks
87142|NCT02040844|O3|Outcome|Placebo|Placebo - 1 dose every 4 weeks
87143|NCT02040844|O2|Outcome|Cat-PAD Treatment (2 Courses)|Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks
87144|NCT02040844|O1|Outcome|Cat-PAD Treatment 1 (1 Course)|Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks
87145|NCT02040844|O3|Outcome|Placebo|Placebo - 1 dose every 4 weeks
87146|NCT02040844|O2|Outcome|Cat-PAD Treatment (2 Courses)|Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks
87147|NCT02040844|O1|Outcome|Cat-PAD Treatment 1 (1 Course)|Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks
87148|NCT02040844|O3|Outcome|Placebo|Placebo - 1 dose every 4 weeks
87149|NCT02040844|O2|Outcome|Cat-PAD Treatment (2 Courses)|Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks
87150|NCT02040844|O1|Outcome|Cat-PAD Treatment 1 (1 Course)|Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks
87151|NCT02040844|O3|Outcome|Placebo|Placebo - 1 dose every 4 weeks
87188|NCT02040779|O3|Outcome|BDP 160 mcg BAI|80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
87189|NCT02040779|O2|Outcome|BDP 80 mcg BAI|40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
87190|NCT02040779|O1|Outcome|Placebo BAI|Placebo breath-actuated inhaler (BAI) twice daily.
87191|NCT02040779|O3|Outcome|BDP 160 mcg BAI|80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
87192|NCT02040779|O2|Outcome|BDP 80 mcg BAI|40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
87193|NCT02040779|O1|Outcome|Placebo BAI|Placebo breath-actuated inhaler (BAI) twice daily.
87194|NCT02040779|O3|Outcome|BDP 160 mcg BAI|80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
87195|NCT02040779|O2|Outcome|BDP 80 mcg BAI|40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
87196|NCT02040779|O1|Outcome|Placebo BAI|Placebo breath-actuated inhaler (BAI) twice daily.
87197|NCT02040779|O3|Outcome|BDP 160 mcg BAI|80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
87198|NCT02040779|O2|Outcome|BDP 80 mcg BAI|40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
87199|NCT02040779|O1|Outcome|Placebo BAI|Placebo breath-actuated inhaler (BAI) twice daily.
87200|NCT02040779|O3|Outcome|BDP 160 mcg BAI|80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
87201|NCT02040779|O2|Outcome|BDP 80 mcg BAI|40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
87202|NCT02040779|O1|Outcome|Placebo BAI|Placebo breath-actuated inhaler (BAI) twice daily.
87203|NCT02040779|O3|Outcome|BDP 160 mcg BAI|80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
87204|NCT02040779|O2|Outcome|BDP 80 mcg BAI|40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
87205|NCT02040779|O1|Outcome|Placebo BAI|Placebo breath-actuated inhaler (BAI) twice daily.
87206|NCT02040779|O3|Outcome|BDP 160 mcg BAI|80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
87207|NCT02040779|O2|Outcome|BDP 80 mcg BAI|40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
87208|NCT02040779|O1|Outcome|Placebo BAI|Placebo breath-actuated inhaler (BAI) twice daily.
87209|NCT02040779|O3|Outcome|BDP 160 mcg BAI|80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
87210|NCT02040779|O2|Outcome|BDP 80 mcg BAI|40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
87211|NCT02040779|O1|Outcome|Placebo BAI|Placebo breath-actuated inhaler (BAI) twice daily.
87212|NCT02040779|O3|Outcome|BDP 160 mcg BAI|80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
87213|NCT02040779|O2|Outcome|BDP 80 mcg BAI|40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
87214|NCT02040779|O1|Outcome|Placebo BAI|Placebo breath-actuated inhaler (BAI) twice daily.
87215|NCT02040779|O3|Outcome|BDP 160 mcg BAI|80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
87216|NCT02040779|O2|Outcome|BDP 80 mcg BAI|40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
87217|NCT02040779|O1|Outcome|Placebo BAI|Placebo breath-actuated inhaler (BAI) twice daily.
87218|NCT02040779|E3|Reported Event|BDP 160 mcg BAI|80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
87219|NCT02040779|E2|Reported Event|BDP 80 mcg BAI|40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
87220|NCT02040779|E1|Reported Event|Placebo BAI|Placebo breath-actuated inhaler (BAI) twice daily.
87221|NCT02040766|B6|Baseline|Total|Total of all reporting groups
87222|NCT02040766|B5|Baseline|BDP 160 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily~Beclomethasone dipropionate"
87223|NCT02040766|B4|Baseline|BDP 80 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily~Beclomethasone dipropionate~Placebo~albuterol/salbutamol 90 mcg: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period"
87224|NCT02040766|B3|Baseline|BDP 160 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily~Beclomethasone dipropionate"
87225|NCT02040766|B2|Baseline|BDP 80 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily~Beclomethasone dipropionate~Placebo~albuterol/salbutamol 90 mcg: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period"
87226|NCT02040766|B1|Baseline|Placebo BAI and MDI|"Placebo breath-actuated inhaler (BAI) twice daily. Plus placebo metered dose inhaler (MDI) twice daily.~Placebo~albuterol/salbutamol 90 mcg: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period"
87227|NCT02040766|P5|Participant Flow|BDP 160 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily~Beclomethasone dipropionate"
87228|NCT02040766|P4|Participant Flow|BDP 80 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily~Beclomethasone dipropionate~Placebo~albuterol/salbutamol 90 mcg: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period"
87229|NCT02040766|P3|Participant Flow|BDP 160 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily~Beclomethasone dipropionate"
87230|NCT02040766|P2|Participant Flow|BDP 80 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily~Beclomethasone dipropionate~Placebo~albuterol/salbutamol 90 mcg: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period"
87231|NCT02040766|P1|Participant Flow|Placebo BAI and MDI|"Placebo breath-actuated inhaler (BAI) twice daily. Plus placebo metered dose inhaler (MDI) twice daily.~Placebo~albuterol/salbutamol 90 mcg: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period"
87232|NCT02040766|O5|Outcome|BDP 160 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily~Beclomethasone dipropionate"
87233|NCT02040766|O4|Outcome|BDP 80 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily~Beclomethasone dipropionate~Placebo~albuterol/salbutamol 90 mcg: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period"
87234|NCT02040766|O3|Outcome|BDP 160 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily~Beclomethasone dipropionate"
87235|NCT02040766|O2|Outcome|BDP 80 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily~Beclomethasone dipropionate~Placebo~albuterol/salbutamol 90 mcg: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period"
87236|NCT02040766|O1|Outcome|Placebo BAI and MDI|"Placebo breath-actuated inhaler (BAI) twice daily. Plus placebo metered dose inhaler (MDI) twice daily.~Placebo~albuterol/salbutamol 90 mcg: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period"
87237|NCT02040766|O5|Outcome|BDP 160 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily~Beclomethasone dipropionate"
87238|NCT02040766|O4|Outcome|BDP 80 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily~Beclomethasone dipropionate~Placebo~albuterol/salbutamol 90 mcg: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period"
87239|NCT02040766|O3|Outcome|BDP 160 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily~Beclomethasone dipropionate"
87240|NCT02040766|O2|Outcome|BDP 80 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily~Beclomethasone dipropionate~Placebo~albuterol/salbutamol 90 mcg: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period"
87241|NCT02040766|O1|Outcome|Placebo BAI and MDI|"Placebo breath-actuated inhaler (BAI) twice daily. Plus placebo metered dose inhaler (MDI) twice daily.~Placebo~albuterol/salbutamol 90 mcg: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period"
87242|NCT02040766|O5|Outcome|BDP 160 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily~Beclomethasone dipropionate"
87243|NCT02040766|O4|Outcome|BDP 80 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily~Beclomethasone dipropionate~Placebo~albuterol/salbutamol 90 mcg: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period"
87244|NCT02040766|O3|Outcome|BDP 160 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily~Beclomethasone dipropionate"
87245|NCT02040766|O2|Outcome|BDP 80 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily~Beclomethasone dipropionate~Placebo~albuterol/salbutamol 90 mcg: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period"
87246|NCT02040766|O1|Outcome|Placebo BAI and MDI|"Placebo breath-actuated inhaler (BAI) twice daily. Plus placebo metered dose inhaler (MDI) twice daily.~Placebo~albuterol/salbutamol 90 mcg: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period"
87247|NCT02040766|O5|Outcome|BDP 160 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily~Beclomethasone dipropionate"
87248|NCT02040766|O4|Outcome|BDP 80 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily~Beclomethasone dipropionate~Placebo~albuterol/salbutamol 90 mcg: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period"
87249|NCT02040766|O3|Outcome|BDP 160 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily~Beclomethasone dipropionate"
87250|NCT02040766|O2|Outcome|BDP 80 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily~Beclomethasone dipropionate~Placebo~albuterol/salbutamol 90 mcg: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period"
87251|NCT02040766|O1|Outcome|Placebo BAI and MDI|"Placebo breath-actuated inhaler (BAI) twice daily. Plus placebo metered dose inhaler (MDI) twice daily.~Placebo~albuterol/salbutamol 90 mcg: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period"
87252|NCT02040766|O5|Outcome|BDP 160 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily~Beclomethasone dipropionate"
87253|NCT02040766|O4|Outcome|BDP 80 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily~Beclomethasone dipropionate~Placebo~albuterol/salbutamol 90 mcg: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period"
87254|NCT02040766|O3|Outcome|BDP 160 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily~Beclomethasone dipropionate"
87255|NCT02040766|O2|Outcome|BDP 80 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily~Beclomethasone dipropionate~Placebo~albuterol/salbutamol 90 mcg: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period"
87256|NCT02040766|O1|Outcome|Placebo BAI and MDI|"Placebo breath-actuated inhaler (BAI) twice daily. Plus placebo metered dose inhaler (MDI) twice daily.~Placebo~albuterol/salbutamol 90 mcg: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period"
87257|NCT02040766|O5|Outcome|BDP 160 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily~Beclomethasone dipropionate"
87258|NCT02040766|O4|Outcome|BDP 80 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily~Beclomethasone dipropionate~Placebo~albuterol/salbutamol 90 mcg: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period"
87259|NCT02040766|O3|Outcome|BDP 160 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily~Beclomethasone dipropionate"
87260|NCT02040766|O2|Outcome|BDP 80 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily~Beclomethasone dipropionate~Placebo~albuterol/salbutamol 90 mcg: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period"
87261|NCT02040766|O1|Outcome|Placebo BAI and MDI|"Placebo breath-actuated inhaler (BAI) twice daily. Plus placebo metered dose inhaler (MDI) twice daily.~Placebo~albuterol/salbutamol 90 mcg: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period"
87262|NCT02040766|E6|Reported Event|Run-in Placebo|Run-in Placebo
87263|NCT02040766|E5|Reported Event|Placebo|Placebo
87264|NCT02040766|E4|Reported Event|MDI 80 mcg/Day|MDI 80 mcg/day
87265|NCT02040766|E3|Reported Event|MDI 160 mcg/Day|MDI 160 mcg/day
87266|NCT02040766|E2|Reported Event|BAI 80 mcg/Day|BAI 80 mcg/day
87267|NCT02040766|E1|Reported Event|BAI 160 mcg/Day|BAI 160 mcg/day
87268|NCT02040623|B4|Baseline|Total|Total of all reporting groups
87269|NCT02040623|B3|Baseline|Placebo|"Placebo Ophthalmic Solution 2 drops per eye twice a day~Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day"
87270|NCT02040623|B2|Baseline|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day"
87271|NCT02040623|B1|Baseline|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day"
87272|NCT02040623|P3|Participant Flow|Placebo|"Placebo Ophthalmic Solution 2 drops per eye twice a day~Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day"
87273|NCT02040623|P2|Participant Flow|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day"
87274|NCT02040623|P1|Participant Flow|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day"
87275|NCT02040623|O3|Outcome|Placebo|"Placebo Ophthalmic Solution 2 drops per eye twice a day~Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day"
87276|NCT02040623|O2|Outcome|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day"
87277|NCT02040623|O1|Outcome|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day"
87278|NCT02040623|E3|Reported Event|Placebo|"Placebo Ophthalmic Solution 2 drops per eye twice a day~Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day"
87279|NCT02040623|E2|Reported Event|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day"
87280|NCT02040623|E1|Reported Event|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day"
87281|NCT02040532|B1|Baseline|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.~Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
87282|NCT02040532|P1|Participant Flow|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.~Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
87283|NCT02040532|O1|Outcome|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.~Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
87284|NCT02040532|O1|Outcome|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.~Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
87285|NCT02040532|O1|Outcome|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.~Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
87286|NCT02040532|O1|Outcome|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.~Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
87287|NCT02040532|O1|Outcome|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.~Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
87288|NCT02040532|O1|Outcome|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.~Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
87289|NCT02040532|O1|Outcome|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.~Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
87290|NCT02040532|O1|Outcome|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.~Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
87291|NCT02040532|E1|Reported Event|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.~Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
87292|NCT02040428|B3|Baseline|Total|Total of all reporting groups
87293|NCT02040428|B2|Baseline|TachoSil|TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
87294|NCT02040428|B1|Baseline|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
87295|NCT02040428|P2|Participant Flow|TachoSil|TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
87296|NCT02040428|P1|Participant Flow|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
87297|NCT02040428|O2|Outcome|TachoSil|TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
87298|NCT02040428|O1|Outcome|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
87299|NCT02040428|O2|Outcome|TachoSil|TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
87300|NCT02040428|O1|Outcome|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
87301|NCT02040428|O2|Outcome|TachoSil|TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
87302|NCT02040428|O1|Outcome|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
87303|NCT02040428|O2|Outcome|TachoSil|TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
87304|NCT02040428|O1|Outcome|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
87305|NCT02040428|E2|Reported Event|TachoSil|TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
87306|NCT02040428|E1|Reported Event|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
87307|NCT02040116|B1|Baseline|Rituximab Infusion|"Every patient is getting the same therapy of rituximab. If day 1 is tolerated at standard infusion then day 14 and beyond will be given as rapid infusion over 20 hours~Rapid Infusion Rituximab: Participants will receive their first infusion of rituximab at the standard infusion rate provided in the manufacturer labeling. If they tolerate this infusion with a grade 2 of less infusion-related reaction, the next infusion will be administered as a 90 minute rapid infusion."
87308|NCT02040116|P1|Participant Flow|Rituximab Infusion|"Every patient is getting the same therapy of rituximab. If day 1 is tolerated at standard infusion then day 14 and beyond will be given as rapid infusion over 90 minutes~Rapid Infusion Rituximab: Participants will receive their first infusion of rituximab at the standard infusion rate provided in the manufacturer labeling. If they tolerate this infusion with a grade 2 of less infusion-related reaction, the next infusion will be administered as a 90 minute rapid infusion."
87309|NCT02040116|O2|Outcome|Grade of Reactions for Rapid Infusion|day 14 infusion of standard infusion will be graded according to CTCAE
87310|NCT02040116|O1|Outcome|Grade of Reactions for Standard Infusion|day 1 infusion of standard infusion will be graded according to CTCAE
87311|NCT02040116|O1|Outcome|Time in Day Hospital|"The time of infusion will be recorded from the first dose and the second dose~Time in day hospital: time between the two doses will recorded"
87312|NCT02040116|O2|Outcome|Number of Reactions for Rapid Infusion|day 1 infusion of rapid infusion will be given the same to all patients and then assessed
87313|NCT02040116|O1|Outcome|Number of Reactions for Standard Infusion|day 1 infusion of standard infusion will be given the same to all patients and then assessed
87314|NCT02040116|E1|Reported Event|Rituximab Infusion|"Every patient is getting the same therapy of rituximab. If day 1 is tolerated at standard infusion then day 14 and beyond will be given as rapid infusion over 20 hours~Rapid Infusion Rituximab: Participants will receive their first infusion of rituximab at the standard infusion rate provided in the manufacturer labeling. If they tolerate this infusion with a grade 2 of less infusion-related reaction, the next infusion will be administered as a 90 minute rapid infusion."
87315|NCT02040077|B4|Baseline|Total|Total of all reporting groups
87316|NCT02040077|B3|Baseline|Pamphlet|Receive a printed version of the same intervention
87317|NCT02040077|B2|Baseline|Computer Only|Will receive computerized intervention with no embedded questions
87318|NCT02040077|B1|Baseline|Computer + Questions|Will receive computerized intervention and will be required to periodically answer questions embedded within the program correctly to proceed into the next module.
87319|NCT02040077|P3|Participant Flow|Pamphlet|Receive a printed version of the same intervention
87320|NCT02040077|P2|Participant Flow|Computer Only|Will receive computerized intervention with no embedded questions
87321|NCT02040077|P1|Participant Flow|Computer + Questions|Will receive computerized intervention and will be required to periodically answer questions embedded within the program correctly to proceed into the next module.
87322|NCT02040077|O3|Outcome|Pamphlet|Receive a printed version of the same intervention
87323|NCT02040077|O2|Outcome|Computer Only|Will receive computerized intervention with no embedded questions
87324|NCT02040077|O1|Outcome|Computer + Mastery|Will receive computerized intervention and will be required to periodically answer questions embedded within the program correctly to proceed into the next module.
87325|NCT02040077|O3|Outcome|Pamphlet|Receive a printed version of the same intervention
87326|NCT02040077|O2|Outcome|Computer Only|Will receive computerized intervention with no embedded questions.
87327|NCT02040077|O1|Outcome|Computer + Mastery|Will receive computerized intervention and will be required to periodically answer questions embedded within the program correctly to proceed into the next module.
87328|NCT02040077|E3|Reported Event|Pamphlet|Will receive an printed out version of the same intervention.
87329|NCT02040077|E2|Reported Event|Computer Only|Will receive computerized intervention with no embedded questions
87330|NCT02040077|E1|Reported Event|Computer + Mastery|Will receive computerized intervention and will be required to periodically answer questions embedded within the program correctly to proceed into the next module.
87331|NCT02039817|B3|Baseline|Total|Total of all reporting groups
87332|NCT02039817|B2|Baseline|Severe Renal Impairment|Severe Renal Impairment subjects received one 50mg dose of IDN-6556
87333|NCT02039817|B1|Baseline|Healthy Volunteers|Health Volunteers received one 50mg dose of IDN-6556
87334|NCT02039817|P2|Participant Flow|Severe Renal Impairment|Severe Renal Impairment subjects were given a single 50mg dose of IDN-6556
87335|NCT02039817|P1|Participant Flow|Healthy Volumteers|Healthy volunteers were given a single 50mg dose of IDN-6556
87336|NCT02039817|O2|Outcome|Severe Renal Impairment|Subjects received a single 50 mg oral dose of IDN-6556
87337|NCT02039817|O1|Outcome|Healthy Volunteers|Subjects received a single 50 mg oral dose of IDN-6556
87338|NCT02039817|O2|Outcome|Severe Renal Impairment|Subjects received a single 50 mg oral dose of IDN-6556
87339|NCT02039817|O1|Outcome|Healthy Volunteers|Subjects received a single 50 mg oral dose of IDN-6556
87340|NCT02039817|O2|Outcome|Severe Renal Impairment|Subjects received a single 50 mg oral dose of IDN-6556
87341|NCT02039817|O1|Outcome|Healthy Volunteers|Subjects received a single 50 mg oral dose of IDN-6556
87342|NCT02039817|E1|Reported Event|IDN-6556|A single 50mg dose of IDN-6556
87343|NCT02039778|B1|Baseline|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.~Stem Cell Radiotherapy (ScRT) and Temozolomide"
87344|NCT02039778|P1|Participant Flow|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.~Stem Cell Radiotherapy (ScRT) and Temozolomide"
87345|NCT02039778|O1|Outcome|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.~Stem Cell Radiotherapy (ScRT) and Temozolomide"
87346|NCT02039778|O1|Outcome|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.~Stem Cell Radiotherapy (ScRT) and Temozolomide"
87347|NCT02039778|O1|Outcome|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.~Stem Cell Radiotherapy (ScRT) and Temozolomide"
87348|NCT02039778|O1|Outcome|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.~Stem Cell Radiotherapy (ScRT) and Temozolomide"
87349|NCT02039778|O1|Outcome|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.~Stem Cell Radiotherapy (ScRT) and Temozolomide"
87350|NCT02039778|E1|Reported Event|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.~Stem Cell Radiotherapy (ScRT) and Temozolomide"
87351|NCT02039687|B5|Baseline|Total|Total of all reporting groups
87352|NCT02039687|B4|Baseline|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days~Placebo: Formulation buffer"
87353|NCT02039687|B3|Baseline|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
88271|NCT02037477|E4|Reported Event|Cohort 2 - Rabeprazole Sodium 10 mg|Rabeprazole sodium 10 mg, orally, once daily for 7 days.
87354|NCT02039687|B2|Baseline|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
87355|NCT02039687|B1|Baseline|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
87356|NCT02039687|P4|Participant Flow|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days~Placebo: Formulation buffer"
87357|NCT02039687|P3|Participant Flow|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
87358|NCT02039687|P2|Participant Flow|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
87359|NCT02039687|P1|Participant Flow|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
87360|NCT02039687|O4|Outcome|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days~Placebo: Formulation buffer"
87361|NCT02039687|O3|Outcome|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
87362|NCT02039687|O2|Outcome|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
87363|NCT02039687|O1|Outcome|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
87364|NCT02039687|O4|Outcome|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days~Placebo: Formulation buffer"
87365|NCT02039687|O3|Outcome|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
87366|NCT02039687|O2|Outcome|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
87367|NCT02039687|O1|Outcome|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
87368|NCT02039687|O4|Outcome|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days~Placebo: Formulation buffer"
87369|NCT02039687|O3|Outcome|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
87370|NCT02039687|O2|Outcome|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
87371|NCT02039687|O1|Outcome|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
87372|NCT02039687|O4|Outcome|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days~Placebo: Formulation buffer"
87373|NCT02039687|O3|Outcome|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
87374|NCT02039687|O2|Outcome|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
87375|NCT02039687|O1|Outcome|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
87376|NCT02039687|O4|Outcome|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days~Placebo: Formulation buffer"
87377|NCT02039687|O3|Outcome|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
87378|NCT02039687|O2|Outcome|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
87379|NCT02039687|O1|Outcome|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
87380|NCT02039687|E4|Reported Event|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days~Placebo: Formulation buffer"
87381|NCT02039687|E3|Reported Event|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
87382|NCT02039687|E2|Reported Event|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
87383|NCT02039687|E1|Reported Event|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
87384|NCT02039674|B10|Baseline|Total|Total of all reporting groups
87385|NCT02039674|B9|Baseline|Part 2 Cohort H (Pembro+I)|Cohort H participants received pembrolizumab via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab via IV infusion on Day 1 of each 3-week cycle at the recommended Phase II dose determined in Cohort D.
88272|NCT02037477|E3|Reported Event|Cohort 2 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
87386|NCT02039674|B8|Baseline|Part 2 Cohort G- (Placebo+Pe+C)|Cohort G- participants received carboplatin AUC 5 (5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed 500 mg/m^2 via IV infusion on Day 1 of each 3-week cycle PLUS placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle.
87387|NCT02039674|B7|Baseline|Part 2 Cohort G+ (Pembro 200mg+Pe+C)|Cohort G+ participants received carboplatin Area Under the Curve (AUC) 5 (5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed 500 mg/m^2 via IV infusion on Day 1 of each 3-week cycle OR carboplatin AUC 5 (5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed 500 mg/m^2 via IV infusion on Day 1 of each 3-week cycle PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle.
87388|NCT02039674|B6|Baseline|Part 1 Cohort F (Pembro+Gefitinib)|Cohort F participants received pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (250 mg) via PO tablet QD on every day of each 3-week cycle.
87389|NCT02039674|B5|Baseline|Part 1 Cohort E (Pembro+Erlotinib)|Cohort E participants received pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (150 mg) PO tablet QD on every day of each 3-week cycle.
87390|NCT02039674|B4|Baseline|Part 1 Cohort D (Pembro+Ipilimumab [I])|Cohort D participants received pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (0.3, 1, or 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
87391|NCT02039674|B3|Baseline|Part 1 Cohort C (Pembro+Pemetrexed [Pe]+C)|Cohort C participants received pembrolizumab (2 or 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin AUC 5 (5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle.
87392|NCT02039674|B2|Baseline|Part 1 Cohort B (Pembro+Pa+C+Bevacizumab [B])|Cohort B participants received pembrolizumab (2 or 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (6 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
87393|NCT02039674|B1|Baseline|Part 1 Cohort A (Pembro+Paclitaxel [Pa]+Carboplatin [C])|Cohort A participants received pembrolizumab (2 or 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (6 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle.
87394|NCT02039674|P9|Participant Flow|Part 2 Cohort H (Pembro+I)|Cohort H participants received pembrolizumab via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab via IV infusion on Day 1 of each 3-week cycle at the recommended Phase II dose determined in Cohort D.
87395|NCT02039674|P8|Participant Flow|Part 2 Cohort G- (Placebo+Pe+C)|Cohort G- participants received carboplatin AUC 5 (5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed 500 mg/m^2 via IV infusion on Day 1 of each 3-week cycle PLUS placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle.
87396|NCT02039674|P7|Participant Flow|Part 2 Cohort G+ (Pembro 200mg+Pe+C)|Cohort G+ participants received carboplatin Area Under the Curve (AUC) 5 (5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed 500 mg/m^2 via IV infusion on Day 1 of each 3-week cycle OR carboplatin AUC 5 (5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed 500 mg/m^2 via IV infusion on Day 1 of each 3-week cycle PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle.
87397|NCT02039674|P6|Participant Flow|Part 1 Cohort F (Pembro+Gefitinib)|Cohort F participants received pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (250 mg) via PO tablet QD on every day of each 3-week cycle.
87398|NCT02039674|P5|Participant Flow|Part 1 Cohort E (Pembro+Erlotinib)|Cohort E participants received pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (150 mg) via oral (PO) tablet once a day (QD) on every day of each 3-week cycle.
87399|NCT02039674|P4|Participant Flow|Part 1 Cohort D (Pembro+Ipilimumab [I])|Cohort D participants received pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (0.3, 1, or 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
87400|NCT02039674|P3|Participant Flow|Part 1 Cohort C (Pembro+Pemetrexed [Pe]+C)|Cohort C participants received pembrolizumab (2 or 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin Area Under the Curve (AUC) 5 (5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle.
87401|NCT02039674|P2|Participant Flow|Part 1 Cohort B (Pembro+Pa+C+Bevacizumab [B])|Cohort B participants received pembrolizumab (2 or 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (6 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
87402|NCT02039674|P1|Participant Flow|Part 1 Cohort A (Pembro+Paclitaxel [Pa]+Carboplatin [C])|Cohort A participants received pembrolizumab (Pembro; 2 or 10 mg/kg) via intravenous (IV) infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (6 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle.
87403|NCT02039674|O2|Outcome|Part 2 Cohort G- (Placebo+Pe+C)|Cohort G- participants received carboplatin AUC 5 (5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle.
87404|NCT02039674|O1|Outcome|Part 2 Cohort G+ (Pembro 200mg+Pe+C)|Cohort G+ participants received carboplatin AUC 5 (5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS pembrolizumab (200 mg) via IV infusion on Day 1 of each 3-week cycle.
87405|NCT02039674|O2|Outcome|Part 2 Cohort G- (Placebo+Pe+C)|Cohort G- participants received carboplatin AUC 5 (5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle.
87406|NCT02039674|O1|Outcome|Part 2 Cohort G+ (Pembro 200mg+Pe+C)|Cohort G+ participants received carboplatin AUC 5 (5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS pembrolizumab (200 mg) via IV infusion on Day 1 of each 3-week cycle.
87407|NCT02039674|O2|Outcome|Part 2 Cohort G- (Placebo+Pe+C)|Cohort G- participants received carboplatin AUC 5 (5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle.
87474|NCT02039115|B2|Baseline|Placebo|"Placebo tablets will be taken in the same manner as the prednisone arm.~placebo: 6 weeks of placebo therapy will be given in the same manner as the prednisone arm after the first and second stage complete Barretts excision."
87408|NCT02039674|O1|Outcome|Part 2 Cohort G+ (Pembro 200mg+Pe+C)|Cohort G+ participants received carboplatin AUC 5 (5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS pembrolizumab (200 mg) via IV infusion on Day 1 of each 3-week cycle.
87409|NCT02039674|O9|Outcome|Part 2 Cohort H (Pembro+I)|Cohort H participants received pembrolizumab via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab via IV infusion on Day 1 of each 3-week cycle at the recommended Phase II dose determined in Cohort D.
87410|NCT02039674|O8|Outcome|Part 2 Cohort G- (Placebo+Pe+C)|Cohort G- participants receive carboplatin AUC 5 (5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed 500 mg/m^2 via IV infusion on Day 1 of each 3-week cycle PLUS placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle.
87411|NCT02039674|O7|Outcome|Part 2 Cohort G+ (Pembro 200mg+Pe+C)|Cohort G+ participants receive carboplatin AUC 5 (5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed 500 mg/m^2 via IV infusion on Day 1 of each 3-week cycle OR carboplatin AUC 5 (5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed 500 mg/m^2 via IV infusion on Day 1 of each 3-week cycle PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle.
87412|NCT02039674|O6|Outcome|Part 1 Cohort F (Pembro+Gefitinib)|Cohort F participants received pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (250 mg) via PO tablet QD on every day of each 3-week cycle.
87413|NCT02039674|O5|Outcome|Part 1 Cohort E (Pembro+Erlotinib)|Cohort E participants received pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (150 mg) PO tablet QD on every day of each 3-week cycle.
87414|NCT02039674|O4|Outcome|Part 1 Cohort D (Pembro+Ipilimumab [I])|Cohort D participants received pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (0.3, 1, or 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
87415|NCT02039674|O3|Outcome|Part 1 Cohort C (Pembro+Pemetrexed [Pe]+C)|Cohort C participants received pembrolizumab (2 or 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin AUC 5 (5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle.
87416|NCT02039674|O2|Outcome|Part 1 Cohort B (Pembro+Pa+C+Bevacizumab [B])|Cohort B participants received pembrolizumab (2 or 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (6 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
87417|NCT02039674|O1|Outcome|Part 1 Cohort A (Pembro+Paclitaxel [Pa]+Carboplatin [C])|Cohort A participants received pembrolizumab (2 or 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (6 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle.
87418|NCT02039674|O1|Outcome|Part 2 Cohort H (Pembro+I)|Cohort H participants received pembrolizumab via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab via IV infusion on Day 1 of each 3-week cycle at the recommended Phase II dose determined in Cohort D.
87419|NCT02039674|O2|Outcome|Part 2 Cohort G- (Placebo+Pe+C)|Cohort G- participants received carboplatin AUC 5 (5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle.
87420|NCT02039674|O1|Outcome|Part 2 Cohort G+ (Pembro 200mg+Pe+C)|Cohort G+ participants received carboplatin AUC 5 (5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS pembrolizumab (200 mg) via IV infusion on Day 1 of each 3-week cycle.
87421|NCT02039674|E12|Reported Event|Part 2 Cohort H (Pembro+I)|Cohort H participants received pembrolizumab via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab via IV infusion on Day 1 of each 3-week cycle at the recommended Phase II dose determined in Cohort D.
87422|NCT02039674|E11|Reported Event|Part 2 Cohort G- (Placebo+Pe+C)|Cohort G- participants received carboplatin AUC 5 (5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle.
87423|NCT02039674|E10|Reported Event|Part 2 Cohort G+ (Pembro 200mg+Pe+C)|Cohort G+ participants received carboplatin AUC 5 (5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS pembrolizumab (200 mg) via IV infusion on Day 1 of each 3-week cycle.
87424|NCT02039674|E9|Reported Event|Part 1 Cohort F (Pembro+Gefitinib)|Cohort F participants received pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (250 mg) via PO tablet QD on every day of each 3-week cycle.
87425|NCT02039674|E8|Reported Event|Part 1 Cohort E (Pembro+Erlotinib)|Cohort E participants received pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (150 mg) PO tablet QD on every day of each 3-week cycle.
87426|NCT02039674|E7|Reported Event|Part 1 Cohort D (Pembro+Ipilimumab [I])|Cohort D participants received pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (0.3, 1, or 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
87427|NCT02039674|E6|Reported Event|Part 1 Cohort C10 (Pembro 10mg/kg+Pe+C)|Cohort C10 participants received pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin AUC 5 (5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle.
87428|NCT02039674|E5|Reported Event|Part 1 Cohort C2 (Pembro 2mg/kg+Pe+C)|Cohort C2 participants received pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin AUC 5 (5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle.
87429|NCT02039674|E4|Reported Event|Part 1 Cohort B10 (Pembro 10mg/kg+Pa+C+B)|Cohort B10 participants received pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (6 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
87430|NCT02039674|E3|Reported Event|Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])|Cohort B2 participants received pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (6 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
88273|NCT02037477|E2|Reported Event|Cohort 1 - Esomeprazole 20 mg|Esomeprazole 20 mg, orally, once daily for 7 days.
87431|NCT02039674|E2|Reported Event|Part 1 Cohort A10 (Pembro 10mg/kg+Pa+[C])|Cohort A10 participants received pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (6 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle.
87432|NCT02039674|E1|Reported Event|Part1 CohortA2 (Pembro 2mg/kg+Paclitaxel [Pa]+Carboplatin [C])|Cohort A2 participants received pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (6 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle.
87433|NCT02039427|B5|Baseline|Total|Total of all reporting groups
87434|NCT02039427|B4|Baseline|Dexamethasone|"Dexamethasone 10 mg (total volume 2 ml) 5 min before induction Normal saline 2 ml 10 min before end of surgery~Dexamethasone: dexamethasone acetate10 mg : total volume of 2 ml"
87435|NCT02039427|B3|Baseline|Postketorolac|"Normal saline 2 ml 5 min before induction Ketorolac 30 mg 10 min before end of surgery~Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
87436|NCT02039427|B2|Baseline|Preketorolac|"Ketorolac 30 mg 5 min before induction Normal saline 2 ml 10 min before end of surgery~Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
87437|NCT02039427|B1|Baseline|Placebo|"Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery~Placebo: Normal saline 2 ml"
87438|NCT02039427|P4|Participant Flow|Dexamethasone|"Dexamethasone 10 mg at 5 min before induction and Normal saline(Placebo) 2 ml at 10 min before end of surgery~Dexamethasone: dexamethasone acetate 10 mg mixed with normal saline : total volume of 2 ml"
87439|NCT02039427|P3|Participant Flow|Postketorolac|"Normal saline(Placebo) 2 ml at 5 min before induction and Ketorolac 30 mg at 10 min before end of surgery~Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
87440|NCT02039427|P2|Participant Flow|Preketorolac|"Ketorolac 30 mg at 5 min before induction and Normal saline(Placebo) 2 ml at 10 min before end of surgery~Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
87441|NCT02039427|P1|Participant Flow|Placebo|"Normal saline(Placebo) 2 ml at 5 min before induction and Normal saline(Placebo) 2 ml at 10 min before end of surgery~Placebo: Normal saline 2 ml"
87442|NCT02039427|O4|Outcome|Dexamethasone|"Dexamethasone 10 mg at 5 min before induction and Normal saline(Placebo) 2 ml at 10 min before end of surgery~Dexamethasone: dexamethasone acetate 10 mg mixed with normal saline : total volume of 2 ml"
87443|NCT02039427|O3|Outcome|Postketorolac|"Normal saline(Placebo) 2 ml at 5 min before induction and Ketorolac 30 mg at 10 min before end of surgery~Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
87444|NCT02039427|O2|Outcome|Preketorolac|"Ketorolac 30 mg at 5 min before induction and Normal saline(Placebo) 2 ml at 10 min before end of surgery~Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
87445|NCT02039427|O1|Outcome|Placebo|"Normal saline(Placebo) 2 ml at 5 min before induction and Normal saline(Placebo) 2 ml at 10 min before end of surgery~Placebo: Normal saline 2 ml"
87446|NCT02039427|O4|Outcome|Dexamethasone|"Dexamethasone 10 mg (total volume 2 ml) 5 min before induction Normal saline 2 ml 10 min before end of surgery~Dexamethasone: dexamethasone acetate10 mg : total volume of 2 ml"
87447|NCT02039427|O3|Outcome|Postketorolac|"Normal saline 2 ml 5 min before induction Ketorolac 30 mg 10 min before end of surgery~Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
87448|NCT02039427|O2|Outcome|Preketorolac|"Ketorolac 30 mg 5 min before induction Normal saline 2 ml 10 min before end of surgery~Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
87449|NCT02039427|O1|Outcome|Placebo|"Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery~Placebo: Normal saline 2 ml"
87450|NCT02039427|O4|Outcome|Dexamethasone|"Dexamethasone 10 mg (total volume 2 ml) 5 min before induction Normal saline 2 ml 10 min before end of surgery~Dexamethasone: dexamethasone acetate10 mg : total volume of 2 ml"
87451|NCT02039427|O3|Outcome|Postketorolac|"Normal saline 2 ml 5 min before induction Ketorolac 30 mg 10 min before end of surgery~Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
87452|NCT02039427|O2|Outcome|Preketorolac|"Ketorolac 30 mg 5 min before induction Normal saline 2 ml 10 min before end of surgery~Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
87453|NCT02039427|O1|Outcome|Placebo|"Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery~Placebo: Normal saline 2 ml"
87454|NCT02039427|E4|Reported Event|Dexamethasone|"Dexamethasone 10 mg (total volume 2 ml) 5 min before induction Normal saline 2 ml 10 min before end of surgery~Dexamethasone: dexamethasone acetate10 mg : total volume of 2 ml"
87455|NCT02039427|E3|Reported Event|Postketorolac|"Normal saline 2 ml 5 min before induction Ketorolac 30 mg 10 min before end of surgery~Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
87456|NCT02039427|E2|Reported Event|Preketorolac|"Ketorolac 30 mg 5 min before induction Normal saline 2 ml 10 min before end of surgery~Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
87457|NCT02039427|E1|Reported Event|Placebo|"Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery~Placebo: Normal saline 2 ml"
87458|NCT02039414|B3|Baseline|Total|Total of all reporting groups
87459|NCT02039414|B2|Baseline|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
87460|NCT02039414|B1|Baseline|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
87461|NCT02039414|P2|Participant Flow|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
87462|NCT02039414|P1|Participant Flow|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
87463|NCT02039414|O2|Outcome|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
87464|NCT02039414|O1|Outcome|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
87465|NCT02039414|O2|Outcome|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
87466|NCT02039414|O1|Outcome|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
87467|NCT02039414|O2|Outcome|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
87475|NCT02039115|B1|Baseline|Prednisone|"Daily oral prednisone is taken for 6 weeks, at a dose of 40mg/day in week 1, 30mg/day in week 2, 20mg/day week 3 and 4, 10mg/day in week 5, and 5mg/day in week 6. Prednisone is taken in the morning. Treatment commences the day of the procedure, with the dose taken with a sip of water prior to discharge. The 6-week treatment regimen is given after both the 1st and 2nd stage complete Barretts excision.~prednisone: 6 weeks of prednisone and placebo therapy will be given over 6 weeks after both the first and second stage complete Barretts Excision."
87476|NCT02039115|P2|Participant Flow|Placebo|"Placebo tablets will be taken in the same manner as the prednisone arm.~placebo: 6 weeks of placebo therapy will be given in the same manner as the prednisone arm after the first and second stage complete Barretts excision."
87477|NCT02039115|P1|Participant Flow|Prednisone|"Daily oral prednisone is taken for 6 weeks, at a dose of 40mg/day in week 1, 30mg/day in week 2, 20mg/day week 3 and 4, 10mg/day in week 5, and 5mg/day in week 6. Prednisone is taken in the morning. Treatment commences the day of the procedure, with the dose taken with a sip of water prior to discharge. The 6-week treatment regimen is given after both the 1st and 2nd stage complete Barretts excision.~prednisone: 6 weeks of prednisone and placebo therapy will be given over 6 weeks after both the first and second stage complete Barretts Excision."
87478|NCT02039115|O2|Outcome|Placebo|"Placebo tablets will be taken in the same manner as the prednisone arm.~placebo: 6 weeks of placebo therapy will be given in the same manner as the prednisone arm after the first and second stage complete Barretts excision."
87479|NCT02039115|O1|Outcome|Prednisone|"Daily oral prednisone is taken for 6 weeks, at a dose of 40mg/day in week 1, 30mg/day in week 2, 20mg/day week 3 and 4, 10mg/day in week 5, and 5mg/day in week 6. Prednisone is taken in the morning. Treatment commences the day of the procedure, with the dose taken with a sip of water prior to discharge. The 6-week treatment regimen is given after both the 1st and 2nd stage complete Barretts excision.~prednisone: 6 weeks of prednisone and placebo therapy will be given over 6 weeks after both the first and second stage complete Barretts Excision."
87480|NCT02039115|E2|Reported Event|Placebo|"Placebo tablets will be taken in the same manner as the prednisone arm.~placebo: 6 weeks of placebo therapy will be given in the same manner as the prednisone arm after the first and second stage complete Barretts excision."
87481|NCT02039115|E1|Reported Event|Prednisone|"Daily oral prednisone is taken for 6 weeks, at a dose of 40mg/day in week 1, 30mg/day in week 2, 20mg/day week 3 and 4, 10mg/day in week 5, and 5mg/day in week 6. Prednisone is taken in the morning. Treatment commences the day of the procedure, with the dose taken with a sip of water prior to discharge. The 6-week treatment regimen is given after both the 1st and 2nd stage complete Barretts excision.~prednisone: 6 weeks of prednisone and placebo therapy will be given over 6 weeks after both the first and second stage complete Barretts Excision."
87482|NCT02038959|B3|Baseline|Total|Total of all reporting groups
87483|NCT02038959|B2|Baseline|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
87484|NCT02038959|B1|Baseline|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
87485|NCT02038959|P2|Participant Flow|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
87486|NCT02038959|P1|Participant Flow|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
87487|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
87544|NCT02038907|B3|Baseline|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88274|NCT02037477|E1|Reported Event|Cohort 1 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
87488|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
87489|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
87490|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
87491|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
87492|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
87493|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
87494|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
87495|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
87496|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
87497|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
87545|NCT02038907|B2|Baseline|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87498|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
87499|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
87500|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
87501|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
87502|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
87503|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
87504|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
87505|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
87506|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
87507|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
87573|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87508|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
87509|NCT02038959|E2|Reported Event|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
87510|NCT02038959|E1|Reported Event|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
87511|NCT02038933|B3|Baseline|Total|Total of all reporting groups
87512|NCT02038933|B2|Baseline|ASCT-ineligible|Autologous stem cell transplant ineligible
87513|NCT02038933|B1|Baseline|ASCT-failed|Autologous stem cell transplant failed
87514|NCT02038933|P1|Participant Flow|Nivolumab 3mg/kg|Nivolumab 3mg/kg administered as an IV infusion on Treatment Day 1 of each 14 day cycle until disease progression or discontinuation due to toxicity, withdrawal of study consent, or the study ends.
87515|NCT02038933|O2|Outcome|ASCT-ineligible|Autologous stem cell transplant ineligible
87516|NCT02038933|O1|Outcome|ASCT-failed|Autologous stem cell transplant failed
87517|NCT02038933|O2|Outcome|ASCT-ineligible|Autologous stem cell transplant ineligible
87518|NCT02038933|O1|Outcome|ASCT-failed|Autologous stem cell transplant failed
87519|NCT02038933|O2|Outcome|ASCT-ineligible|Autologous stem cell transplant ineligible
87520|NCT02038933|O1|Outcome|ASCT-failed|Autologous stem cell transplant failed
87521|NCT02038933|O2|Outcome|ASCT-ineligible|Autologous stem cell transplant ineligible
87522|NCT02038933|O1|Outcome|ASCT-failed|Autologous stem cell transplant failed
87523|NCT02038933|O2|Outcome|ASCT-ineligible|Autologous stem cell transplant ineligible
87524|NCT02038933|O1|Outcome|ASCT-failed|Autologous stem cell transplant failed
87525|NCT02038933|O2|Outcome|ASCT-ineligible|Autologous stem cell transplant ineligible
87526|NCT02038933|O1|Outcome|ASCT-failed|Autologous stem cell transplant failed
87527|NCT02038933|O2|Outcome|ASCT-ineligible|Autologous stem cell transplant ineligible
87528|NCT02038933|O1|Outcome|ASCT-failed|Autologous stem cell transplant failed
87529|NCT02038933|O2|Outcome|ASCT-ineligible|Autologous stem cell transplant ineligible
87530|NCT02038933|O1|Outcome|ASCT-failed|Autologous stem cell transplant failed
87531|NCT02038933|E1|Reported Event|NIVOLUMAB 3 mg/kg|Nivolumab 3mg/kg administered as an IV infusion on Treatment Day 1 of each 14 day cycle until disease progression or discontinuation due to toxicity, withdrawal of study consent, or the study ends.
87532|NCT02038907|B15|Baseline|Total|Total of all reporting groups
87533|NCT02038907|B14|Baseline|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87534|NCT02038907|B13|Baseline|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87535|NCT02038907|B12|Baseline|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87536|NCT02038907|B11|Baseline|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87537|NCT02038907|B10|Baseline|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87538|NCT02038907|B9|Baseline|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87539|NCT02038907|B8|Baseline|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87540|NCT02038907|B7|Baseline|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87541|NCT02038907|B6|Baseline|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87542|NCT02038907|B5|Baseline|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87543|NCT02038907|B4|Baseline|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87546|NCT02038907|B1|Baseline|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87547|NCT02038907|P14|Participant Flow|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87548|NCT02038907|P13|Participant Flow|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87549|NCT02038907|P12|Participant Flow|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87550|NCT02038907|P11|Participant Flow|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87551|NCT02038907|P10|Participant Flow|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87552|NCT02038907|P9|Participant Flow|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87553|NCT02038907|P8|Participant Flow|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87554|NCT02038907|P7|Participant Flow|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87555|NCT02038907|P6|Participant Flow|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87556|NCT02038907|P5|Participant Flow|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87557|NCT02038907|P4|Participant Flow|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87558|NCT02038907|P3|Participant Flow|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87559|NCT02038907|P2|Participant Flow|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87560|NCT02038907|P1|Participant Flow|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87561|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87562|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87563|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87564|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87565|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87566|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87567|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87568|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87569|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87570|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87571|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87572|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88325|NCT02036840|O1|Outcome|Penicillin Allergy|Antibiotic
87574|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87575|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87576|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87577|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87578|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87579|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87580|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87581|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87582|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87583|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87584|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87585|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87586|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87587|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87588|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87589|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87590|NCT02038907|O1|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87591|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87592|NCT02038907|O1|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87593|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87594|NCT02038907|O1|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87595|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87596|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87597|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87598|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87599|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87600|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87655|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87601|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87602|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87603|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87604|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87605|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87606|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87607|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87608|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87609|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87610|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87611|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87612|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87613|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87614|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87615|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87616|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87617|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87618|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87619|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87620|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87621|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87622|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87623|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87624|NCT02038907|O1|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87625|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87626|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87627|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
88326|NCT02036840|E1|Reported Event|Penicillin Allergy|Antibiotic
87628|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87629|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87630|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87631|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87632|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87633|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87634|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87635|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87636|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87637|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87638|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87639|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87640|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87641|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87642|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87643|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87644|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87645|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87646|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87647|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87648|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87649|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87650|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87651|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87652|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87653|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87654|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
88434|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
87656|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87657|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87658|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87659|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87660|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87661|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87662|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87663|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87664|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87665|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87666|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87667|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87668|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87669|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87670|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87671|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87672|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87673|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87674|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87675|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87676|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87677|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87678|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87679|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87680|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87681|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87682|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
88435|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
87683|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87684|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87685|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87686|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87687|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87688|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87689|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87690|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87691|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87692|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87693|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87694|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87695|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87696|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87697|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87698|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87699|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87700|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87701|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87702|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87703|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87704|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87705|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87706|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87707|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87708|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87709|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
88436|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
87710|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87711|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87712|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87713|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87714|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87715|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87716|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87717|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87718|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87719|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87720|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87721|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87722|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87723|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87724|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87725|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87726|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87727|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87728|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87729|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87730|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87731|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87732|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87733|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87734|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87735|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87736|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
88357|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
87737|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87738|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87739|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87740|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87741|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87742|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87743|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87744|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87745|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87746|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87747|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87748|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87749|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87750|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87751|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87752|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87753|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87754|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87755|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87756|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87757|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87758|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87759|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87760|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87761|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87762|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87763|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87926|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87764|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87765|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87766|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87767|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87768|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87769|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87770|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87771|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87772|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87773|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87774|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87775|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87776|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87777|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87778|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87779|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87780|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87781|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87782|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87783|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87784|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87785|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87786|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87787|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87788|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87789|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87790|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88090|NCT02038829|P10|Participant Flow|Treatment Group 10|Participants received SUN-101 12.5 mcg SUN-101 6.25mcg Placebo; Aclidinium 400mcg; SUN-101 50 mcg SUN-101 3mcg
87791|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87792|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87793|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87794|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87795|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87796|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87797|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87798|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87799|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87800|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87801|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87802|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87803|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87804|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87805|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87806|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87807|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87808|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87809|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87810|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87811|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87812|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87813|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87814|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87815|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87816|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87817|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88091|NCT02038829|P9|Participant Flow|Treatment Group 9|Participants received SUN-101 6.25mcg Aclidinium 400mcg; SUN-101 12.5 mcg SUN-101 3mcg Placebo; SUN-101 50mcg
87818|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87819|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87820|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87821|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87822|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87823|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87824|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87825|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87826|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87827|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87828|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87829|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87830|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87831|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87832|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87833|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87834|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87835|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87836|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87837|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87838|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87839|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87840|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87841|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87842|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87843|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87844|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
88092|NCT02038829|P8|Participant Flow|Treatment Group 8|Participants received Aclidinium 400mcg; SUN-101 3mcg SUN-101 6.25mcg SUN-101 50mcg SUN-101 12.5 mcg; Placebo;
87845|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87846|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87847|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87848|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87849|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87850|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87851|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87852|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87853|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87854|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87855|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87856|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87857|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87858|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87859|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87860|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87861|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87862|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87863|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87864|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87865|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87866|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87867|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87868|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87869|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87870|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87871|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88093|NCT02038829|P7|Participant Flow|Treatment Group 7|"Participants received SUN-101 3mcg SUN-101 50mcg Aclidinium 400mcg; Placebo; SUN-101 6.25mcg SUN-101 12.5 mcg;~SUN-101 3mcg"
87872|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87873|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87874|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87875|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87876|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87877|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87878|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87879|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87880|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87881|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87882|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87883|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87884|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87885|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87886|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87887|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87888|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87889|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87890|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87891|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87892|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87893|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87894|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87895|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87896|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87897|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87898|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88094|NCT02038829|P6|Participant Flow|Treatment Group 6|"Participants received Aclidinium 400mcg; SUN-101 6.25mcg SUN-101 50mcg SUN-101 12.5 mcg; Placebo; SUN-101 3mcg~Placebo;"
87899|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87900|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87901|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87902|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87903|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87904|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87905|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87906|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87907|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87908|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87909|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87910|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87911|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87912|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87913|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87914|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87915|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87916|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87917|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87918|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87919|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87920|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87921|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87922|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87923|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87924|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87925|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88253|NCT02037477|O2|Outcome|Cohort 1 - Esomeprazole 20 mg|Esomeprazole 20 mg, orally, once daily for 7 days.
87927|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87928|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87929|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87930|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87931|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87932|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87933|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87934|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87935|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87936|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87937|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87938|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87939|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87940|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87941|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87942|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87943|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87944|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87945|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87946|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87947|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87948|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87949|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87950|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87951|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87952|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87953|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88254|NCT02037477|O1|Outcome|Cohort 1 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
87954|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87955|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87956|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87957|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87958|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87959|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87960|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87961|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87962|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87963|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87964|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87965|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87966|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87967|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87968|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87969|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87970|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87971|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87972|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87973|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87974|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87975|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87976|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87977|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87978|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87979|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87980|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88255|NCT02037477|O4|Outcome|Cohort 2 - Rabeprazole Sodium 10 mg|Rabeprazole sodium 10 mg, orally, once daily for 7 days.
87981|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87982|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87983|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87984|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87985|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87986|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87987|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87988|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
87989|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87990|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87991|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
87992|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
87993|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87994|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87995|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87996|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
87997|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
87998|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
87999|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88000|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88001|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88002|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
88003|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
88004|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
88005|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
88006|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
88007|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88256|NCT02037477|O3|Outcome|Cohort 2 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
88008|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88009|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88010|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88011|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88012|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
88013|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88014|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88015|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88016|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
88017|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
88018|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
88019|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
88020|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
88021|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88022|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88023|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88024|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88025|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88026|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
88027|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88028|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88029|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88030|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
88031|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
88032|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
88033|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
88034|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
88257|NCT02037477|O2|Outcome|Cohort 1 - Esomeprazole 20 mg|Esomeprazole 20 mg, orally, once daily for 7 days.
88035|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88036|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88037|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88038|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88039|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88040|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
88041|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88042|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88043|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88044|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
88045|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
88046|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
88047|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
88048|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
88049|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88050|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88051|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88052|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88053|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88054|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
88055|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88056|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88057|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88058|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
88059|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
88060|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
88061|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
88258|NCT02037477|O1|Outcome|Cohort 1 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
88062|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
88063|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88064|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88065|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88066|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88067|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88068|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
88069|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88070|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88071|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88072|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
88073|NCT02038907|E14|Reported Event|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
88074|NCT02038907|E13|Reported Event|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
88075|NCT02038907|E12|Reported Event|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
88076|NCT02038907|E11|Reported Event|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
88077|NCT02038907|E10|Reported Event|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88078|NCT02038907|E9|Reported Event|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88079|NCT02038907|E8|Reported Event|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88080|NCT02038907|E7|Reported Event|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
88081|NCT02038907|E6|Reported Event|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88082|NCT02038907|E5|Reported Event|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
88083|NCT02038907|E4|Reported Event|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88084|NCT02038907|E3|Reported Event|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88085|NCT02038907|E2|Reported Event|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
88086|NCT02038907|E1|Reported Event|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
88087|NCT02038829|B1|Baseline|Total|Total of all participants
88088|NCT02038829|P12|Participant Flow|Treatment Group 12|Participants received SUN-101 50 mcg Placebo; SUN-101 3mcg SUN-101 6.25mcg Aclidinium 400mcg; SUN-101 12.5 mcg
88089|NCT02038829|P11|Participant Flow|Treatment Group 11|Participants received Placebo; SUN-101 12.5 mcg SUN-101 50 mcg SUN-101 6.25mcg Aclidinium 400mcg; SUN-101 3mcg
88095|NCT02038829|P5|Participant Flow|Treatment Group 5|"Participants received SUN-101 6.25mcg SUN-101 12.5 mcg; Aclidinium 400mcg; SUN-101 3mcg SUN-101 50mcg Placebo;~Aclidinium 400mcg; SUN-101 6.25mcg"
88096|NCT02038829|P4|Participant Flow|Treatment Group 4|Participants received SUN-101 12.5 mcg; SUN-101 3mcg Placebo; SUN-101 50mcg; Aclidinium 400mcg; SUN-101 6.25mcg
88097|NCT02038829|P3|Participant Flow|Treatment Group 3|Participants received SUN-101 3mcg Placebo; SUN-101 12.5 mcg; SUN-101 50mcg; SUN-101 6.25mcg Aclidinium 400mcg;
88098|NCT02038829|P2|Participant Flow|Treatment Group 2|Participants received Placebo; SUN-101 50mcg; SUN-101 3mcg Aclidinium 400mcg; SUN-101 12.5 mcg; SUN-101 6mcg
88099|NCT02038829|P1|Participant Flow|Treatment Group 1|Participants received SUN-101 50mcg; Aclidinium 400mcg; Placebo; SUN-101 6,25mcg; SUN-101 3mcg; SUN-101 12.5mcg
88100|NCT02038829|O7|Outcome|TOTAL|Total number of study participants
88101|NCT02038829|O6|Outcome|Aclidinium 400 mcg|"Aclidinium 400 mcg bid~Aclidinium: Aclidinium 400 mcg bid"
88102|NCT02038829|O5|Outcome|SUN-101 50 mcg|"SUN-101 50 mcg bid~SUN-101 50 mcg: SUN-101 50 mcg bid"
88103|NCT02038829|O4|Outcome|SUN-101 12.5 mcg|"SUN-101 12.5 mcg bid~SUN-101 12.5 mcg: SUN-101 12.5 mcg bid"
88104|NCT02038829|O3|Outcome|SUN-101 6.25 mcg|"SUN-101 6.25 mcg bid~SUN-101 6.25 mcg: SUN-101 6.25 mcg bid"
88105|NCT02038829|O2|Outcome|SUN-101 3 mcg|"SUN-101 3 mcg bid~SUN101 3 mcg: SUN-101 3 mcg bid"
88106|NCT02038829|O1|Outcome|Placebo|"Placebo bid~Placebo: Placebo"
88107|NCT02038829|O7|Outcome|TOTAL|Total number of study participants
88108|NCT02038829|O6|Outcome|Aclidinium 400 mcg|"Aclidinium 400 mcg bid~Aclidinium: Aclidinium 400 mcg bid"
88109|NCT02038829|O5|Outcome|SUN-101 50 mcg|"SUN-101 50 mcg bid~SUN-101 50 mcg: SUN-101 50 mcg bid"
88110|NCT02038829|O4|Outcome|SUN-101 12.5 mcg|"SUN-101 12.5 mcg bid~SUN-101 12.5 mcg: SUN-101 12.5 mcg bid"
88111|NCT02038829|O3|Outcome|SUN-101 6.25 mcg|"SUN-101 6.25 mcg bid~SUN-101 6.25 mcg: SUN-101 6.25 mcg bid"
88112|NCT02038829|O2|Outcome|SUN-101 3 mcg|"SUN-101 3 mcg bid~SUN101 3 mcg: SUN-101 3 mcg bid"
88113|NCT02038829|O1|Outcome|Placebo|"Placebo bid~Placebo: Placebo"
88114|NCT02038829|O6|Outcome|Aclidinium 400 mcg|"Aclidinium 400 mcg bid~Aclidinium: Aclidinium 400 mcg bid"
88115|NCT02038829|O5|Outcome|SUN-101 50 mcg|"SUN-101 50 mcg bid~SUN-101 50 mcg: SUN-101 50 mcg bid"
88116|NCT02038829|O4|Outcome|SUN-101 12.5 mcg|"SUN-101 12.5 mcg bid~SUN-101 12.5 mcg: SUN-101 12.5 mcg bid"
88117|NCT02038829|O3|Outcome|SUN-101 6.25 mcg|"SUN-101 6.25 mcg bid~SUN-101 6.25 mcg: SUN-101 6.25 mcg bid"
88118|NCT02038829|O2|Outcome|SUN-101 3 mcg|"SUN-101 3 mcg bid~SUN101 3 mcg: SUN-101 3 mcg bid"
88119|NCT02038829|O1|Outcome|Placebo|"Placebo bid~Placebo: Placebo"
88120|NCT02038829|O6|Outcome|Aclidinium 400 mcg|"Aclidinium 400 mcg bid~Aclidinium: Aclidinium 400 mcg bid"
88121|NCT02038829|O5|Outcome|SUN-101 50 mcg|"SUN-101 50 mcg bid~SUN-101 50 mcg: SUN-101 50 mcg bid"
88122|NCT02038829|O4|Outcome|SUN-101 12.5 mcg|"SUN-101 12.5 mcg bid~SUN-101 12.5 mcg: SUN-101 12.5 mcg bid"
88123|NCT02038829|O3|Outcome|SUN-101 6.25 mcg|"SUN-101 6.25 mcg bid~SUN-101 6.25 mcg: SUN-101 6.25 mcg bid"
88124|NCT02038829|O2|Outcome|SUN-101 3 mcg|"SUN-101 3 mcg bid~SUN101 3 mcg: SUN-101 3 mcg bid"
88125|NCT02038829|O1|Outcome|Placebo|"Placebo bid~Placebo: Placebo"
88126|NCT02038829|E6|Reported Event|Aclidinium 400 mcg|"Aclidinium 400 mcg bid~Aclidinium: Aclidinium 400 mcg bid"
88127|NCT02038829|E5|Reported Event|SUN-101 50 mcg|"SUN-101 50 mcg bid~SUN-101 50 mcg: SUN-101 50 mcg bid"
88128|NCT02038829|E4|Reported Event|SUN-101 12.5 mcg|"SUN-101 12.5 mcg bid~SUN-101 12.5 mcg: SUN-101 12.5 mcg bid"
88129|NCT02038829|E3|Reported Event|SUN-101 6.25 mcg|"SUN-101 6.25 mcg bid~SUN-101 6.25 mcg: SUN-101 6.25 mcg bid"
88130|NCT02038829|E2|Reported Event|SUN-101 3 mcg|"SUN-101 3 mcg bid~SUN101 3 mcg: SUN-101 3 mcg bid"
88131|NCT02038829|E1|Reported Event|Placebo|"Placebo bid~Placebo: Placebo"
88132|NCT02038790|B1|Baseline|All Participants|Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
88133|NCT02038790|P2|Participant Flow|Zubsolv - Suboxone|Participants received Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 0 and Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 1.
88134|NCT02038790|P1|Participant Flow|Suboxone - Zubsolv|Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1.
88135|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
88136|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
88137|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
88138|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
88139|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
88140|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
88141|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
88142|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
88259|NCT02037477|O4|Outcome|Cohort 2 - Rabeprazole Sodium 10 mg|Rabeprazole sodium 10 mg, orally, once daily for 7 days.
88143|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
88144|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
88145|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
88146|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
88147|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
88148|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
88149|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
88150|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
88151|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
88152|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
88153|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
88154|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
88155|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
88156|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
88157|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
88158|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
88159|NCT02038790|O1|Outcome|All Participants|Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
88160|NCT02038790|O1|Outcome|All Participants|Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
88161|NCT02038790|O1|Outcome|All Participants|Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
88162|NCT02038790|E2|Reported Event|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
88163|NCT02038790|E1|Reported Event|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
88164|NCT02038543|B5|Baseline|Total|Total of all reporting groups
88165|NCT02038543|B4|Baseline|PH Type Non 1,2,3|Subjects who presented with overproduction of oxalate, leading to recurrent kidney and bladder stones, but are not identified a PH types 1, 2, or 3.
88166|NCT02038543|B3|Baseline|PH Type 3|In primary hyperoxaluria type 3, affected individuals often develop kidney stones in early childhood, but few cases of this type have been described so additional signs and symptoms of this type are unclear.
88167|NCT02038543|B2|Baseline|PH Type 2|Primary hyperoxaluria type 2 is similar to type 1, but end stage renal disease (ESRD) develops later in life.
88168|NCT02038543|B1|Baseline|PH Type 1|In primary hyperoxaluria type 1, kidney stones typically begin to appear anytime from childhood to early adulthood, and end stage renal disease (ESRD) can develop at any age.
88169|NCT02038543|P4|Participant Flow|PH Type Non 1,2,3|Subjects who presented with overproduction of oxalate, leading to recurrent kidney and bladder stones, but are not identified as primary hyperoxaluria (PH) types 1, 2, or 3.
88170|NCT02038543|P3|Participant Flow|PH Type 3|In primary hyperoxaluria type 3, affected individuals often develop kidney stones in early childhood, but few cases of this type have been described so additional signs and symptoms of this type are unclear.
88171|NCT02038543|P2|Participant Flow|PH Type 2|Primary hyperoxaluria type 2 is similar to type 1, but end stage renal disease (ESRD) develops later in life.
88172|NCT02038543|P1|Participant Flow|PH Type 1|In primary hyperoxaluria type 1, kidney stones typically begin to appear anytime from childhood to early adulthood, and end stage renal disease (ESRD) can develop at any age.
88173|NCT02038543|O4|Outcome|PH Type Non 1,2,3|Subjects who presented with overproduction of oxalate, leading to recurrent kidney and bladder stones, but are not identified as PH types 1, 2, or 3.
88174|NCT02038543|O3|Outcome|PH Type 3|In primary hyperoxaluria type 3, affected individuals often develop kidney stones in early childhood, but few cases of this type have been described so additional signs and symptoms of this type are unclear.
88175|NCT02038543|O2|Outcome|PH Type 2|Primary hyperoxaluria type 2 is similar to type 1, but end stage renal disease (ESRD) develops later in life.
88176|NCT02038543|O1|Outcome|PH Type 1|In primary hyperoxaluria type 1, kidney stones typically begin to appear anytime from childhood to early adulthood, and end stage renal disease (ESRD) can develop at any age.
88177|NCT02038543|O4|Outcome|PH Type Non 1,2,3|Subjects who presented with overproduction of oxalate, leading to recurrent kidney and bladder stones, but are not identified as PH types 1, 2, or 3.
88178|NCT02038543|O3|Outcome|PH Type 3|In primary hyperoxaluria type 3, affected individuals often develop kidney stones in early childhood, but few cases of this type have been described so additional signs and symptoms of this type are unclear.
88179|NCT02038543|O2|Outcome|PH Type 2|Primary hyperoxaluria type 2 is similar to type 1, but end stage renal disease (ESRD) develops later in life.
88180|NCT02038543|O1|Outcome|PH Type 1|In primary hyperoxaluria type 1, kidney stones typically begin to appear anytime from childhood to early adulthood, and end stage renal disease (ESRD) can develop at any age.
88181|NCT02038543|E4|Reported Event|PH Type Non 1,2,3|Subjects who presented with overproduction of oxalate, leading to recurrent kidney and bladder stones, but are not identified a PH types 1, 2, or 3.
88182|NCT02038543|E3|Reported Event|PH Type 3|In primary hyperoxaluria type 3, affected individuals often develop kidney stones in early childhood, but few cases of this type have been described so additional signs and symptoms of this type are unclear.
88183|NCT02038543|E2|Reported Event|PH Type 2|Primary hyperoxaluria type 2 is similar to type 1, but end stage renal disease (ESRD) develops later in life.
88184|NCT02038543|E1|Reported Event|PH Type 1|In primary hyperoxaluria type 1, kidney stones typically begin to appear anytime from childhood to early adulthood, and end stage renal disease (ESRD) can develop at any age.
88185|NCT02038075|B3|Baseline|Total|Total of all reporting groups
88186|NCT02038075|B2|Baseline|Treatment As Usual (TAU)|"Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.~Treatment As Usual (TAU)"
88187|NCT02038075|B1|Baseline|Brief Cognitive Behavioral Therapy (BCBT)|"In addition to TAU, participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.~Brief Cognitive Behavioral Therapy (BCBT)"
88188|NCT02038075|P2|Participant Flow|Treatment As Usual (TAU)|"Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.~Treatment As Usual (TAU)"
88189|NCT02038075|P1|Participant Flow|Brief Cognitive Behavioral Therapy (BCBT)|"In addition to TAU, participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.~Brief Cognitive Behavioral Therapy (BCBT)"
88190|NCT02038075|O2|Outcome|Treatment As Usual (TAU)|"Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.~Treatment As Usual (TAU)"
88191|NCT02038075|O1|Outcome|Brief Cognitive Behavioral Therapy (BCBT)|"In addition to TAU, participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.~Brief Cognitive Behavioral Therapy (BCBT)"
88192|NCT02038075|E2|Reported Event|Treatment As Usual (TAU)|"Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.~Treatment As Usual (TAU)"
88260|NCT02037477|O3|Outcome|Cohort 2 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
88261|NCT02037477|O2|Outcome|Cohort 1 - Esomeprazole 20 mg|Esomeprazole 20 mg, orally, once daily for 7 days.
88262|NCT02037477|O1|Outcome|Cohort 1 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
88263|NCT02037477|O4|Outcome|Cohort 2 - Rabeprazole Sodium 10 mg|Rabeprazole sodium 10 mg, orally, once daily for 7 days.
88264|NCT02037477|O3|Outcome|Cohort 2 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
88265|NCT02037477|O2|Outcome|Cohort 1 - Esomeprazole 20 mg|Esomeprazole 20 mg, orally, once daily for 7 days.
88193|NCT02038075|E1|Reported Event|Brief Cognitive Behavioral Therapy (BCBT)|"In addition to TAU, participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.~Brief Cognitive Behavioral Therapy (BCBT)"
88194|NCT02037776|B3|Baseline|Total|Total of all reporting groups
88195|NCT02037776|B2|Baseline|Rikkunshito|Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
88196|NCT02037776|B1|Baseline|Rikkunshito Placebo|Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
88197|NCT02037776|P2|Participant Flow|Rikkunshito|Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
88198|NCT02037776|P1|Participant Flow|Rikkunshito Placebo|Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
88199|NCT02037776|O2|Outcome|Rikkunshito|Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
88200|NCT02037776|O1|Outcome|Rikkunshito Placebo|Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
88201|NCT02037776|O2|Outcome|Rikkunshito|Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
88202|NCT02037776|O1|Outcome|Rikkunshito Placebo|Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
88203|NCT02037776|O2|Outcome|Rikkunshito|Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
88204|NCT02037776|O1|Outcome|Rikkunshito Placebo|Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
88205|NCT02037776|O2|Outcome|Rikkunshito|Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
88206|NCT02037776|O1|Outcome|Rikkunshito Placebo|Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
88207|NCT02037776|O2|Outcome|Rikkunshito|Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
88208|NCT02037776|O1|Outcome|Rikkunshito Placebo|Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
88209|NCT02037776|O2|Outcome|Rikkunshito|Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
88210|NCT02037776|O1|Outcome|Rikkunshito Placebo|Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
88211|NCT02037776|E2|Reported Event|Rikkunshito|Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
88212|NCT02037776|E1|Reported Event|Rikkunshito Placebo|Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
88213|NCT02037607|B1|Baseline|Ultrasound Group (All)|All subjects in the study are in the same group. Study procedure is ultrasound within 48 hours prior to surgery and a repeat within 72 hours after surgery.
88214|NCT02037607|P1|Participant Flow|Ultrasound Group (All)|All subjects in the study are in the same group. Study procedure is ultrasound
88215|NCT02037607|O1|Outcome|Ultrasound Group (All)|All subjects in the study are in the same group. Study procedure is ultrasound
88216|NCT02037607|E1|Reported Event|Ultrasound Group (All)|All subjects in the study are in the same group. Study procedure is ultrasound
88217|NCT02037568|B3|Baseline|Total|Total of all reporting groups
88218|NCT02037568|B2|Baseline|Caregiver Intervention (PEPRR 2.0)|"Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.~fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors"
88219|NCT02037568|B1|Baseline|Caregiver Self-Directed (TAU)|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
88220|NCT02037568|P2|Participant Flow|Caregiver Intervention (PEPRR 2.0)|"Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.~fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors"
88221|NCT02037568|P1|Participant Flow|Caregiver Self-Directed (TAU)|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
88266|NCT02037477|O1|Outcome|Cohort 1 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
88267|NCT02037477|O4|Outcome|Cohort 2 - Rabeprazole Sodium 10 mg|Rabeprazole sodium 10 mg, orally, once daily for 7 days.
88268|NCT02037477|O3|Outcome|Cohort 2 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
88222|NCT02037568|O2|Outcome|Caregiver Intervention (PEPRR 2.0)|"Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.~fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors"
88223|NCT02037568|O1|Outcome|Caregiver Self-Directed (TAU)|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
88224|NCT02037568|O2|Outcome|Caregiver Intervention (PEPRR 2.0)|"Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.~fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors"
88225|NCT02037568|O1|Outcome|Caregiver Self-Directed (TAU)|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
88226|NCT02037568|O2|Outcome|Caregiver Intervention (PEPRR 2.0)|"Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.~fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors"
88227|NCT02037568|O1|Outcome|Caregiver Self-Directed (TAU)|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
88228|NCT02037568|O2|Outcome|Caregiver Intervention (PEPRR 2.0)|"Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.~fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors"
88229|NCT02037568|O1|Outcome|Caregiver Self-Directed (TAU)|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
88230|NCT02037568|O2|Outcome|Caregiver Intervention (PEPRR 2.0)|"Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.~fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors"
88231|NCT02037568|O1|Outcome|Caregiver Self-Directed (TAU)|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
88232|NCT02037568|O2|Outcome|Caregiver Intervention (PEPRR 2.0)|"Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.~fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors"
88233|NCT02037568|O1|Outcome|Caregiver Self-Directed (TAU)|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
88234|NCT02037568|O2|Outcome|Caregiver Intervention (PEPRR 2.0)|"Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.~fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors"
88235|NCT02037568|O1|Outcome|Caregiver Self-Directed (TAU)|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
88236|NCT02037568|O2|Outcome|Caregiver Intervention (PEPRR 2.0)|"Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.~fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors"
88237|NCT02037568|O1|Outcome|Caregiver Self-Directed (TAU)|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
88238|NCT02037568|O2|Outcome|Caregiver Intervention (PEPRR 2.0)|"Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.~fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors"
88239|NCT02037568|O1|Outcome|Caregiver Self-Directed (TAU)|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
88240|NCT02037568|E2|Reported Event|Caregiver Intervention (PEPRR 2.0)|"Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.~fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors"
88241|NCT02037568|E1|Reported Event|Caregiver Self-Directed (TAU)|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
88242|NCT02037477|B5|Baseline|Total|Total of all reporting groups
88243|NCT02037477|B4|Baseline|Sequence D (Cohort 2): Rabeprazole Sodium + Vonoprazan|Rabeprazole sodium 10 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then vonoprazan 20 mg, orally, once daily for 7 days.
88244|NCT02037477|B3|Baseline|Sequence C (Cohort 2): Vonoprazan + Rabeprazole Sodium|Vonoprazan 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then rabeprazole sodium 10 mg, orally, once daily for 7 days.
88245|NCT02037477|B2|Baseline|Sequence B (Cohort 1): Esomeprazole + Vonoprazan|Esomeprazole 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then vonoprazan 20 mg, orally, once daily for 7 days.
88246|NCT02037477|B1|Baseline|Sequence A (Cohort 1): Vonoprazan + Esomeprazole|Vonoprazan (TAK-438) 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then esomeprazole 20 mg, orally, once daily for 7 days.
88247|NCT02037477|P4|Participant Flow|Sequence D (Cohort 2): Rabeprazole Sodium + Vonoprazan|Rabeprazole sodium 10 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then vonoprazan 20 mg, orally, once daily for 7 days.
88248|NCT02037477|P3|Participant Flow|Sequence C (Cohort 2): Vonoprazan + Rabeprazole Sodium|Vonoprazan 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then rabeprazole sodium 10 mg, orally, once daily for 7 days.
88249|NCT02037477|P2|Participant Flow|Sequence B (Cohort 1): Esomeprazole + Vonoprazan|Esomeprazole 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then vonoprazan 20 mg, orally, once daily for 7 days.
88250|NCT02037477|P1|Participant Flow|Sequence A (Cohort 1): Vonoprazan + Esomeprazole|Vonoprazan (TAK-438) 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then esomeprazole 20 mg, orally, once daily for 7 days.
88251|NCT02037477|O4|Outcome|Cohort 2 - Rabeprazole Sodium 10 mg|Rabeprazole sodium 10 mg, orally, once daily for 7 days.
88252|NCT02037477|O3|Outcome|Cohort 2 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
88416|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
88275|NCT02037425|B1|Baseline|onabotulinumtoxinA|At visit 2, subjects will receive their first treatment at Day 29 (+/-3 days). All subjects will receive 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas. Injections will be repeated at day 113 (+/- 3 days) and at day 197 (+/- 3 days). A total of 30 subjects were used in data analysis as 2 subjects did not complete any outcome measures once enrolled in the study.
88276|NCT02037425|P1|Participant Flow|onabotulinumtoxinA|At visit 2, subjects will receive their first treatment at Day 29 (+/-3 days). All subjects will receive 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas. Injections will be repeated at day 113 (+/- 3 days) and at day 197 (+/- 3 days).
88277|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
88278|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
88279|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
88280|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
88281|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
88282|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
88283|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
88284|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
88285|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
88286|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
88287|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
88288|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
88289|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
88290|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
88291|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
88292|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
88293|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
88294|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
88295|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
88296|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
88297|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
88298|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
88299|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
88300|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
88301|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
88302|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
88303|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
88304|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
88305|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
88306|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
88307|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
88308|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
88309|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
88310|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
88311|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
88312|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
88313|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
88314|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
88315|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
88316|NCT02037425|E1|Reported Event|onabotulinumtoxinA|At visit 2, subjects will receive their first treatment at Day 29 (+/-3 days). All subjects will receive 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas. Injections will be repeated at day 113 (+/- 3 days) and at day 197 (+/- 3 days).
88317|NCT02037347|B1|Baseline|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
88318|NCT02037347|P1|Participant Flow|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
88319|NCT02037347|O1|Outcome|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
88320|NCT02037347|O1|Outcome|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
88321|NCT02037347|O1|Outcome|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
88322|NCT02037347|E1|Reported Event|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
88323|NCT02036840|B1|Baseline|Penicillin Allergy|Antibiotic
88324|NCT02036840|P1|Participant Flow|Penicillin Allergy|Antibiotic
88327|NCT02036775|B1|Baseline|Study Overall|"A randomised, open-label, three period, crossover study. The three treatments administered were:~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)~Each subject received one treatment per treatment period. Each of the three treatment phases was 6 days long, where study drug was administered on day 1-5 during each treatment."
88328|NCT02036775|P6|Participant Flow|Lasolvan 75mg / Lasolvan 60mg / Lasolvan 30mg|"Patients were administered three treatments in the following order:~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)"
88329|NCT02036775|P5|Participant Flow|Lasolvan 30mg / Lasolvan 75mg / Lasolvan 60mg|"Patients were administered three treatments in the following order:~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days"
88330|NCT02036775|P4|Participant Flow|Lasolvan 60mg / Lasolvan 30mg / Lasolvan 75mg|"Patients were administered three treatments in the following order:~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days"
88331|NCT02036775|P3|Participant Flow|Lasolvan 30mg / Lasolvan 60mg / Lasolvan 75mg|"Patients were administered three treatments in the following order:~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days"
88332|NCT02036775|P2|Participant Flow|Lasolvan 60mg / Lasolvan 75mg / Lasolvan 30mg|"Patients were administered three treatments in the following order:~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)"
88333|NCT02036775|P1|Participant Flow|Lasolvan 75mg / Lasolvan 30mg / Lasolvan 60mg|"Patients were administered three treatments in the following order:~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days"
88334|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
88335|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
88336|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
88337|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
88338|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
88339|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
88340|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
88341|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
88342|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
88343|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
88344|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
88345|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
88346|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
88347|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
88348|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
88349|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
88350|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
88351|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
88352|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
88353|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
88354|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
88355|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
88356|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
88358|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
88359|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
88360|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
88361|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
88362|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
88363|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
88364|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
88365|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
88366|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
88367|NCT02036775|E3|Reported Event|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
88368|NCT02036775|E2|Reported Event|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
88369|NCT02036775|E1|Reported Event|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
88370|NCT02036580|B4|Baseline|Total|Total of all reporting groups
88371|NCT02036580|B3|Baseline|Placebo|Placebo Q4W intravenously dosed for 24 weeks
88372|NCT02036580|B2|Baseline|High Dose|Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
88373|NCT02036580|B1|Baseline|Low Dose|Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
88374|NCT02036580|P3|Participant Flow|Placebo|Placebo Q4W intravenously dosed for 24 weeks
88375|NCT02036580|P2|Participant Flow|High Dose|Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
88376|NCT02036580|P1|Participant Flow|Low Dose|Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
88377|NCT02036580|O3|Outcome|Placebo|Placebo Q4W intravenously dosed for 24 weeks
88378|NCT02036580|O2|Outcome|High Dose|Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
88379|NCT02036580|O1|Outcome|Low Dose|Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
88380|NCT02036580|O2|Outcome|High Dose|Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
88381|NCT02036580|O1|Outcome|Low Dose|Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
88382|NCT02036580|O3|Outcome|Placebo|Placebo Q4W intravenously dosed for 24 weeks
88383|NCT02036580|O2|Outcome|High Dose|Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
88384|NCT02036580|O1|Outcome|Low Dose|Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
88385|NCT02036580|E3|Reported Event|Placebo|Placebo Q4W intravenously dosed for 24 weeks
88386|NCT02036580|E2|Reported Event|High Dose|Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
88387|NCT02036580|E1|Reported Event|Low Dose|Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
88388|NCT02036541|B1|Baseline|XEN 45 Gel Stent|Placement of the XEN 45 Gel Stent in the study eye
88389|NCT02036541|P1|Participant Flow|XEN 45 Gel Stent|Placement of the XEN 45 Gel Stent in the study eye
88390|NCT02036541|O1|Outcome|XEN 45 Gel Stent|Placement of the XEN 45 Gel Stent in the study eye
88391|NCT02036541|O1|Outcome|XEN 45 Gel Stent|Placement of the XEN 45 Gel Stent in the study eye
88392|NCT02036541|E1|Reported Event|XEN 45 Gel Stent|Placement of the XEN 45 Gel Stent in the study eye
88393|NCT02036515|B4|Baseline|Total|Total of all reporting groups
88394|NCT02036515|B3|Baseline|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
88395|NCT02036515|B2|Baseline|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
88396|NCT02036515|B1|Baseline|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
88397|NCT02036515|P3|Participant Flow|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
88398|NCT02036515|P2|Participant Flow|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
88399|NCT02036515|P1|Participant Flow|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
88400|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
88401|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
88402|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
88403|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
88404|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
88405|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
88406|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
88407|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
88408|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
88409|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
88410|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
88411|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
88412|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
88413|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
88414|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
88415|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
88437|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
88438|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
88439|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
88440|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
88441|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
88442|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
88443|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
88444|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
88445|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
88446|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
88447|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
88448|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
88449|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
88450|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
88451|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
88452|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
88453|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
88454|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
88455|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
88456|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
88457|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
88458|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
88459|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
88460|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
88461|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
88462|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
88463|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
88464|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
88465|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
88466|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
88467|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
88468|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
88469|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
88470|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
88471|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
88472|NCT02036515|E3|Reported Event|Placebo (Phase A+B)|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
88473|NCT02036515|E2|Reported Event|Ertugliflozin 15 mg (Phase A+B)|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
88474|NCT02036515|E1|Reported Event|Ertugliflozin 5 mg (Phase A+B)|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
88475|NCT02036424|B3|Baseline|Total|Total of all reporting groups
88476|NCT02036424|B2|Baseline|Ozurdex|"Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections~Ozurdex: intravitreal steroid"
88477|NCT02036424|B1|Baseline|Bevacizumab|"1.25 mg intravitreal injection given monthly during a 6 month period~Bevacizumab: antiVEGF"
88478|NCT02036424|P2|Participant Flow|Ozurdex|"Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections~Ozurdex: intravitreal steroid"
88479|NCT02036424|P1|Participant Flow|Bevacizumab|"1.25 mg intravitreal injection given monthly during a 6 month period~Bevacizumab: antiVEGF"
88480|NCT02036424|O2|Outcome|Ozurdex|"Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections~Ozurdex: intravitreal steroid"
88481|NCT02036424|O1|Outcome|Bevacizumab|"1.25 mg intravitreal injection given monthly during a 6 month period~Bevacizumab: antiVEGF"
88482|NCT02036424|O2|Outcome|Ozurdex|"Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections~Ozurdex: intravitreal steroid"
88483|NCT02036424|O1|Outcome|Bevacizumab|"1.25 mg intravitreal injection given monthly during a 6 month period~Bevacizumab: antiVEGF"
88484|NCT02036424|E2|Reported Event|Ozurdex|"Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections~Ozurdex: intravitreal steroid"
88485|NCT02036424|E1|Reported Event|Bevacizumab|"1.25 mg intravitreal injection given monthly during a 6 month period~Bevacizumab: antiVEGF"
88486|NCT02036320|B1|Baseline|Overall|All subjects that were dispensed a test article during the study.
88487|NCT02036320|P2|Participant Flow|Test 2/Test 1|Subjects who received test lens 2 first and then received test lens 1.
88488|NCT02036320|P1|Participant Flow|Test 1/Test 2|Subjects who received test lens 1 first and then received test lens 2.
88489|NCT02036320|O2|Outcome|Test 2|Subjects that received Test lens 2 during the first or second period of the study.
88490|NCT02036320|O1|Outcome|Test 1|Subjects that received Test lens 1 during the first or second period of the study.
88491|NCT02036320|O2|Outcome|Test 2|Subjects that received Test lens 2 during the first or second period of the study.
88492|NCT02036320|O1|Outcome|Test 1|Subjects that received Test lens 1 during the first or second period of the study.
88493|NCT02036320|O2|Outcome|Test 2|Subjects that received Test lens 2 during the first or second period of the study.
88494|NCT02036320|O1|Outcome|Test 1|Subjects that received Test lens 1 during the first or second period of the study.
88495|NCT02036320|E2|Reported Event|Test 2|Subjects that received Test lens 2 during the first or second period of the study.
88496|NCT02036320|E1|Reported Event|Test 1|Subjects that received Test lens 1 during the first or second period of the study.
88497|NCT02035748|B1|Baseline|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
88498|NCT02035748|P1|Participant Flow|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
88499|NCT02035748|O1|Outcome|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
88500|NCT02035748|O1|Outcome|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
88501|NCT02035748|O1|Outcome|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
88502|NCT02035748|O1|Outcome|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
88503|NCT02035748|O1|Outcome|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
88504|NCT02035748|O1|Outcome|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
88505|NCT02035748|E2|Reported Event|Ocriplasmin|All subjects exposed to the investigational product
88506|NCT02035748|E1|Reported Event|Pretreatment|All subjects consented to participate in the study prior to the initiation of study treatment
88507|NCT02035696|B5|Baseline|Total|Total of all reporting groups
88508|NCT02035696|B4|Baseline|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
88509|NCT02035696|B3|Baseline|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
88510|NCT02035696|B2|Baseline|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
88511|NCT02035696|B1|Baseline|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
88512|NCT02035696|P4|Participant Flow|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
88513|NCT02035696|P3|Participant Flow|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
88514|NCT02035696|P2|Participant Flow|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
88515|NCT02035696|P1|Participant Flow|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
88516|NCT02035696|O4|Outcome|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
88517|NCT02035696|O3|Outcome|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
88518|NCT02035696|O2|Outcome|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
88519|NCT02035696|O1|Outcome|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
88520|NCT02035696|O4|Outcome|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
88521|NCT02035696|O3|Outcome|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
88522|NCT02035696|O2|Outcome|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
88523|NCT02035696|O1|Outcome|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
88524|NCT02035696|O4|Outcome|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
88525|NCT02035696|O3|Outcome|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
88526|NCT02035696|O2|Outcome|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
88527|NCT02035696|O1|Outcome|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
88528|NCT02035696|O4|Outcome|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
88529|NCT02035696|O3|Outcome|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
88530|NCT02035696|O2|Outcome|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
88531|NCT02035696|O1|Outcome|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
88532|NCT02035696|O4|Outcome|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
88533|NCT02035696|O3|Outcome|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
88534|NCT02035696|O2|Outcome|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
88535|NCT02035696|O1|Outcome|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
88536|NCT02035696|O4|Outcome|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
88537|NCT02035696|O3|Outcome|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
88538|NCT02035696|O2|Outcome|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
88539|NCT02035696|O1|Outcome|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
88540|NCT02035696|O4|Outcome|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
88541|NCT02035696|O3|Outcome|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
88542|NCT02035696|O2|Outcome|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
88543|NCT02035696|O1|Outcome|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
88544|NCT02035696|O4|Outcome|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
88545|NCT02035696|O3|Outcome|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
88546|NCT02035696|O2|Outcome|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
88547|NCT02035696|O1|Outcome|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
88548|NCT02035696|O4|Outcome|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
88549|NCT02035696|O3|Outcome|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
88550|NCT02035696|O2|Outcome|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
88551|NCT02035696|O1|Outcome|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
88552|NCT02035696|O3|Outcome|TIVc- Half Dose-TIVe|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine vs Subjects (6 to <48 months old) received two doses of TIVe vaccine
88553|NCT02035696|O2|Outcome|TIVc-Full Dose-TIVe|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine vs Subjects (6 to <48 months old) received two doses of TIVe vaccine
88554|NCT02035696|O1|Outcome|TIVc-High Dose-TIVe|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine vs Subjects (6 to <48 months old) received two doses of TIVe vaccine
88555|NCT02035696|O4|Outcome|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
88556|NCT02035696|O3|Outcome|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
88557|NCT02035696|O2|Outcome|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
88558|NCT02035696|O1|Outcome|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
88559|NCT02035696|O4|Outcome|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
88560|NCT02035696|O3|Outcome|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
88561|NCT02035696|O2|Outcome|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
88562|NCT02035696|O1|Outcome|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
88563|NCT02035696|E5|Reported Event|Total|Total number of subjects
88564|NCT02035696|E4|Reported Event|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
88565|NCT02035696|E3|Reported Event|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
88566|NCT02035696|E2|Reported Event|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
88567|NCT02035696|E1|Reported Event|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
88568|NCT02035553|B3|Baseline|Total|Total of all reporting groups
88569|NCT02035553|B2|Baseline|Pimavanserin 40 mg|Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin)
88570|NCT02035553|B1|Baseline|Placebo|Placebo, two tablets, once daily by mouth
88571|NCT02035553|P2|Participant Flow|Pimavanserin 40 mg|Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin)
88572|NCT02035553|P1|Participant Flow|Placebo|Placebo, two tablets, once daily by mouth
88573|NCT02035553|O2|Outcome|Pimavanserin 40 mg|Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin)
88574|NCT02035553|O1|Outcome|Placebo|Placebo, two tablets, once daily by mouth
88575|NCT02035553|E2|Reported Event|Pimavanserin 40 mg|Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin)
88576|NCT02035553|E1|Reported Event|Placebo|Placebo, two tablets, once daily by mouth
88577|NCT02035475|B1|Baseline|Intuitive Vessel Sealer|"Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.~Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control."
88578|NCT02035475|P1|Participant Flow|Intuitive Vessel Sealer|"Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.~Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control."
88579|NCT02035475|O1|Outcome|Study Participants|"Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.~Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control."
88580|NCT02035475|O2|Outcome|Fenestrated Maryland BiPolar Instrument|The Fenestrated Maryland BiPolar Instrument was utilized on one side of the body, with each participant receiving both treatments, one each side.
88581|NCT02035475|O1|Outcome|EndoWrist 1 Vessel Sealer|"Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.~The EndoWrist 1 Vessel Sealer was utilized on one side of the body, with each participant receiving both treatments, one each side."
88582|NCT02035475|E1|Reported Event|Study Participants|"Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.~Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control."
88583|NCT02035345|B1|Baseline|Carboplatin|"Carboplatin will be prepared as a single 500ml infusion. Potentially 6 cycles Carboplatin (Amount of total dose) will be administered intravenously by the treating nurse according to the following schedule:~First hour - Administer 1 percent of total dose (5ml with tubing primed)~Second hour - Administer 9 percent (45 mL)~Third hour - Administer 90 percent (450 mL)~Carboplatin"
88584|NCT02035345|P1|Participant Flow|Carboplatin|"Carboplatin will be prepared as a single 500ml infusion. Potentially 6 cycles Carboplatin (Amount of total dose) will be administered intravenously by the treating nurse according to the following schedule:~First hour - Administer 1 percent of total dose (5ml with tubing primed)~Second hour - Administer 9 percent (45 mL)~Third hour - Administer 90 percent (450 mL)~Carboplatin"
88585|NCT02035345|O1|Outcome|Carboplatin|"Carboplatin will be prepared as a single 500ml infusion. Potentially 6 cycles Carboplatin (Amount of total dose) will be administered intravenously by the treating nurse according to the following schedule:~First hour - Administer 1 percent of total dose (5ml with tubing primed)~Second hour - Administer 9 percent (45 mL)~Third hour - Administer 90 percent (450 mL)~Carboplatin"
88586|NCT02035345|O1|Outcome|Carboplain Slowed Infusion Group Reactors|Patients that received carboplatin via slowed infusion that developed a reaction
88662|NCT02034799|E2|Reported Event|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
88587|NCT02035345|E1|Reported Event|Carboplatin|"Carboplatin will be prepared as a single 500ml infusion. Potentially 6 cycles Carboplatin (Amount of total dose) will be administered intravenously by the treating nurse according to the following schedule:~First hour - Administer 1 percent of total dose (5ml with tubing primed)~Second hour - Administer 9 percent (45 mL)~Third hour - Administer 90 percent (450 mL)~Carboplatin"
88588|NCT02035332|B1|Baseline|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
88589|NCT02035332|P1|Participant Flow|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
88590|NCT02035332|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
88591|NCT02035332|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
88592|NCT02035332|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
88593|NCT02035332|E1|Reported Event|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
88594|NCT02034916|B3|Baseline|Total|Total of all reporting groups
88595|NCT02034916|B2|Baseline|Cohort 2: Talazoparib 1 mg|Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88596|NCT02034916|B1|Baseline|Cohort 1: Talazoparib 1 mg|Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88597|NCT02034916|P2|Participant Flow|Cohort 2: Talazoparib 1 mg|Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88598|NCT02034916|P1|Participant Flow|Cohort 1: Talazoparib 1 mg|Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 milligram (mg) orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88599|NCT02034916|O2|Outcome|Cohort 2: Talazoparib 1 mg|Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88600|NCT02034916|O1|Outcome|Cohort 1: Talazoparib 1 mg|Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88601|NCT02034916|O2|Outcome|Cohort 2: Talazoparib 1 mg|Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88602|NCT02034916|O1|Outcome|Cohort 1: Talazoparib 1 mg|Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88614|NCT02034916|O2|Outcome|Cohort 2: Talazoparib 1 mg|Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88603|NCT02034916|O1|Outcome|Cohort 1 + Cohort 2: Talazoparib 1 mg|Participants, who either responded to a prior platinum-containing treatment for metastatic breast cancer or had more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. For the participants with non-platinum chemotherapy, prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88604|NCT02034916|O2|Outcome|Cohort 2: Talazoparib 1 mg|Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88605|NCT02034916|O1|Outcome|Cohort 1: Talazoparib 1 mg|Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88606|NCT02034916|O2|Outcome|Cohort 2: Talazoparib 1 mg|Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88607|NCT02034916|O1|Outcome|Cohort 1: Talazoparib 1 mg|Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88608|NCT02034916|O2|Outcome|Cohort 2: Talazoparib 1 mg|Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88609|NCT02034916|O1|Outcome|Cohort 1: Talazoparib 1 mg|Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88610|NCT02034916|O2|Outcome|Cohort 2: Talazoparib 1 mg|Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88611|NCT02034916|O1|Outcome|Cohort 1: Talazoparib 1 mg|Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88612|NCT02034916|O2|Outcome|Cohort 2: Talazoparib 1 mg|Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88613|NCT02034916|O1|Outcome|Cohort 1: Talazoparib 1 mg|Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88660|NCT02034799|O2|Outcome|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
88661|NCT02034799|O1|Outcome|Standard of Care (SoC)|Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH).
88615|NCT02034916|O1|Outcome|Cohort 1: Talazoparib 1 mg|Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88616|NCT02034916|O2|Outcome|Cohort 2: Talazoparib 1 mg|Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88617|NCT02034916|O1|Outcome|Cohort 1: Talazoparib 1 mg|Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88618|NCT02034916|O2|Outcome|Cohort 2: Talazoparib 1 mg|Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88619|NCT02034916|O1|Outcome|Cohort 1: Talazoparib 1 mg|Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88620|NCT02034916|O2|Outcome|Cohort 2: Talazoparib 1 mg|Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88621|NCT02034916|O1|Outcome|Cohort 1: Talazoparib 1 mg|Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88622|NCT02034916|O2|Outcome|Cohort 2: Talazoparib 1 mg|Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88623|NCT02034916|O1|Outcome|Cohort 1: Talazoparib 1 mg|Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88624|NCT02034916|O2|Outcome|Cohort 2: Talazoparib 1 mg|Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88625|NCT02034916|O1|Outcome|Cohort 1: Talazoparib 1 mg|Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88626|NCT02034916|O2|Outcome|Cohort 2: Talazoparib 1 mg|Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88627|NCT02034916|O1|Outcome|Cohort 1: Talazoparib 1 mg|Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88628|NCT02034916|E2|Reported Event|Cohort 2: Talazoparib 1 mg|Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88629|NCT02034916|E1|Reported Event|Cohort 1: Talazoparib 1 mg|Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
88630|NCT02034877|B3|Baseline|Total|Total of all reporting groups
88631|NCT02034877|B2|Baseline|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
88632|NCT02034877|B1|Baseline|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
88633|NCT02034877|P2|Participant Flow|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
88634|NCT02034877|P1|Participant Flow|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
88635|NCT02034877|O2|Outcome|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
88636|NCT02034877|O1|Outcome|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
88637|NCT02034877|O2|Outcome|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
88638|NCT02034877|O1|Outcome|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
88639|NCT02034877|O2|Outcome|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
88640|NCT02034877|O1|Outcome|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
88641|NCT02034877|O2|Outcome|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
88642|NCT02034877|O1|Outcome|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
88643|NCT02034877|O2|Outcome|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
88644|NCT02034877|O1|Outcome|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
88645|NCT02034877|O2|Outcome|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
88646|NCT02034877|O1|Outcome|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
88647|NCT02034877|E2|Reported Event|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
88648|NCT02034877|E1|Reported Event|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
88649|NCT02034799|B3|Baseline|Total|Total of all reporting groups
88650|NCT02034799|B2|Baseline|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen Bioseal Fibrin Sealant
88651|NCT02034799|B1|Baseline|Standard of Care (SoC)|Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH). Standard of Care (SoC)
88652|NCT02034799|P2|Participant Flow|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
88653|NCT02034799|P1|Participant Flow|Standard of Care (SoC)|SoC include Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH).
88654|NCT02034799|O2|Outcome|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
88655|NCT02034799|O1|Outcome|Standard of Care (SoC)|Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH).
88656|NCT02034799|O2|Outcome|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
88657|NCT02034799|O1|Outcome|Standard of Care (SoC)|Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH).
88658|NCT02034799|O2|Outcome|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
88659|NCT02034799|O1|Outcome|Standard of Care (SoC)|Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH).
88663|NCT02034799|E1|Reported Event|Standard of Care (SoC)|Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH).
88664|NCT02034708|B3|Baseline|Total|Total of all reporting groups
88665|NCT02034708|B2|Baseline|Gadovist®/Dotarem®|"Gadovist®/Gadavist®-enhanced MRI then Dotarem® enhanced MRI~Dotarem®: 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.~Gadovist®/Gadavist®: 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus."
88666|NCT02034708|B1|Baseline|Dotarem®/Gadovist®|"Dotarem®-enhanced MRI, then Gadovist®/Gadavist®-enhanced MRI~Dotarem®: 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.~Gadovist®/Gadavist®: 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus."
88667|NCT02034708|P2|Participant Flow|Gadovist®/Dotarem®|"Gadovist®/Gadavist®-enhanced MRI then Dotarem® enhanced MRI~Dotarem®: 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.~Gadovist®/Gadavist®: 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus."
88668|NCT02034708|P1|Participant Flow|Dotarem®/Gadovist®|"Dotarem®-enhanced MRI, then Gadovist®/Gadavist®-enhanced MRI~Dotarem®: 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.~Gadovist®/Gadavist®: 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus."
88669|NCT02034708|O6|Outcome|Dotarem® (Reader 3)|Patients who received Dotarem® Results for reader 3
88670|NCT02034708|O5|Outcome|Gadovist® (Reader 3)|Patients who received Gadovist® Results for reader 3
88671|NCT02034708|O4|Outcome|Dotarem® (Reader 2)|Patients who received Dotarem® Results for reader 2
88672|NCT02034708|O3|Outcome|Gadovist® (Reader 2)|Patients who received Gadovist® Results for reader 2
88673|NCT02034708|O2|Outcome|Dotarem® (Reader 1)|Patients who received Dotarem® Results for reader 1
88674|NCT02034708|O1|Outcome|Gadovist® (Reader 1)|Patients who received Gadovist® Results for reader 1
88675|NCT02034708|E3|Reported Event|Total|Patients who received at least one injection of contrast agent
88676|NCT02034708|E2|Reported Event|Gadovist®|Patients who received Gadovist®
88677|NCT02034708|E1|Reported Event|Dotarem®|Patients who received Dotarem®
88678|NCT02034591|B1|Baseline|All Treatment Groups|All Randomized Participants
88679|NCT02034591|P6|Participant Flow|Treatment C, Then Treatment B, Then Treatment A|"Each participant was given three interventions, one per period, with a 4 day washout in between periods~Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe~Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT~Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
88680|NCT02034591|P5|Participant Flow|Treatment C, Then Treatment A, Then Treatment B|"Each participant was given three interventions, one per period, with a 4 day washout in between periods~Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe~Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT~Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
88681|NCT02034591|P4|Participant Flow|Treatment B, Then Treatment C, Then Treatment A|"Each participant was given three interventions, one per period, with a 4 day washout in between periods~Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe~Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT~Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
88682|NCT02034591|P3|Participant Flow|Treatment B, Then Treatment A, Then Treatment C|"Each participant was given three interventions, one per period, with a 4 day washout in between periods~Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe~Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT~Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
88683|NCT02034591|P2|Participant Flow|Treatment A, Then Treatment C, Then Treatment B|"Each participant was given three interventions, one per period, with a 4 day washout in between periods~Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe~Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT~Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
88684|NCT02034591|P1|Participant Flow|Treatment A, Then Treatment B, Then Treatment C|"Each participant was given three interventions, one per period, with a 4 day washout in between periods~Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe~Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT~Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
88685|NCT02034591|O3|Outcome|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
88686|NCT02034591|O2|Outcome|Treatment B|Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
88687|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
88688|NCT02034591|O3|Outcome|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
88689|NCT02034591|O2|Outcome|Treatment B|Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
88690|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
88691|NCT02034591|O2|Outcome|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
88692|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
88693|NCT02034591|O2|Outcome|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
88694|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
88695|NCT02034591|O2|Outcome|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
88696|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
88697|NCT02034591|O2|Outcome|Treatment B|Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
88698|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
88699|NCT02034591|O2|Outcome|Treatment B|Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
88700|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
88701|NCT02034591|O2|Outcome|Treatment B|Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
88702|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
88703|NCT02034591|E3|Reported Event|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
88704|NCT02034591|E2|Reported Event|Treatment B|Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
88705|NCT02034591|E1|Reported Event|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
88706|NCT02034578|B1|Baseline|5mg Apixaban|After a 10 hour fast, participants were randomized to one of six treatment sequences (ABC, ACB, BAC, BCA, CAB or CBA) administered over 3 periods. Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. Treatment A was administered via oral syringe, Treatment B was administered via an NGT followed by 60 mL of D5W via an NGT, and Treatment C was administered via an NGT, followed by 60 mL of infant formula via an NGT. There was at least a 4 day washout before receiving the next scheduled treatment in the next period.
88707|NCT02034578|P6|Participant Flow|Treatment C, Then Treatment B, Then Treatment A|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.~Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.~Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.~After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
88708|NCT02034578|P5|Participant Flow|Treatment C, Then Treatment A, Then Treatment B|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.~Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.~Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.~After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
88709|NCT02034578|P4|Participant Flow|Treatment B, Then Treatment C, Then Treatment A|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.~Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.~Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.~After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
88736|NCT02034578|E2|Reported Event|5mg Apixaban Via NGT Followed by D5W (B)|In Treatment B the single dose of 5 mg apixaban was administered via nasogastric tube (NGT) followed by 60 mL of dextrose, water (D5W) via the NGT.
88803|NCT02034162|P3|Participant Flow|Open-label Mebendazole 500 mg|Mebendazole 500-mg chewable tablet was administered in an open label manner at visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3).
88710|NCT02034578|P3|Participant Flow|Treatment B, Then Treatment A, Then Treatment C|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.~Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.~Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.~After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
88711|NCT02034578|P2|Participant Flow|Treatment A, Then Treatment C, Then Treatment B|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.~Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.~Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.~After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
88712|NCT02034578|P1|Participant Flow|Treatment A, Then Treatment B, Then Treatment C|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.~Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.~Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.~After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
88713|NCT02034578|O1|Outcome|5mg Apixaban|After a 10 hour fast, participants were randomized on Day 1 of Period 1 to one of six treatment sequences (ABC, ACB, BAC, BCA, CAB or CBA) and received a single dose of apixaban 5 mg. Treatment A was administered via oral syringe, Treatment B was administered via an NGT followed by 60 mL of D5W via an NGT, and Treatment C was administered via an NGT, followed by 60 mL of infant formula via an NGT. There was at least a 4 day washout before receiving the next scheduled treatment in Period 2 and Period 3.
88714|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
88715|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
88716|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
88717|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
88718|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
88719|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
88720|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
88721|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
88722|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
88723|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
88724|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
88725|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
88726|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
88727|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
88728|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
88729|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
88730|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
88731|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
88732|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
88733|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
88734|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
88735|NCT02034578|E3|Reported Event|5 mg Apixaban Via NGT Followed by Infant Formula (C)|In Treatment C, the single dose of 5 mg apixaban was administered via NGT, followed by 60 mL of infant formula via the NGT.
88800|NCT02034162|B3|Baseline|Total|Total of all reporting groups
88737|NCT02034578|E1|Reported Event|5mg Apixaban Via Oral Syringe (A)|"After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences administered over 3 Periods (ABC, ACB, BAC, BCA, CAB or CBA) and received a single dose of apixaban 5 mg. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3.~In Treatment A the single dose of 5 mg apixaban was administered via oral syringe."
88738|NCT02034565|B1|Baseline|All Treatment Groups|All Randomized Participants
88739|NCT02034565|P2|Participant Flow|Treatment B, Then Treatment A|"Each participant was given two interventions, one per period, with a 4 day washout in between periods.~Treatment A: Single dose apixaban film-coated tablet, 10 milligrams (mg) via 2 x 5 mg tablets, administered orally~Treatment B: Single dose apixaban solution, 10 milligrams (mg) via 25 milliliters (mL) x 0.4 mg/mL, administered orally"
88740|NCT02034565|P1|Participant Flow|Treatment A, Then Treatment B|"Each participant was given two interventions, one per period, with a 4 day washout in between periods.~Treatment A: Single dose apixaban film-coated tablet, 10 milligrams (mg) via 2 x 5 mg tablets, administered orally~Treatment B: Single dose apixaban solution, 10 milligrams (mg) via 25 milliliters (mL) x 0.4 mg/mL, administered orally"
88741|NCT02034565|O2|Outcome|Arm B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
88742|NCT02034565|O1|Outcome|Arm A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
88743|NCT02034565|O2|Outcome|Arm B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
88744|NCT02034565|O1|Outcome|Arm A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
88745|NCT02034565|O2|Outcome|Treatment B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
88746|NCT02034565|O1|Outcome|Treatment A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
88747|NCT02034565|O2|Outcome|Treatment B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
88748|NCT02034565|O1|Outcome|Treatment A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
88749|NCT02034565|O2|Outcome|Treatment B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
88750|NCT02034565|O1|Outcome|Treatment A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
88751|NCT02034565|E2|Reported Event|Arm B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
88752|NCT02034565|E1|Reported Event|Arm A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
88753|NCT02034552|B4|Baseline|Total|Total of all reporting groups
88754|NCT02034552|B3|Baseline|Radium-223 With Enzalutamide|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus) and enzalutamide 160 mg daily (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
88755|NCT02034552|B2|Baseline|Radium-223 With Abiraterone & Prednision|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus), abiraterone acetate 1000 mg daily, and prednisone 5 mg bid (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
88756|NCT02034552|B1|Baseline|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of National Institute of Standards and Technology (NIST) update) every 4 weeks x 6 doses IV (slow bolus).
88757|NCT02034552|P3|Participant Flow|Radium-223 With Enzalutamide|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus) and enzalutamide 160 mg daily (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
88758|NCT02034552|P2|Participant Flow|Radium-223 With Abiraterone & Prednision|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus), abiraterone acetate 1000 mg daily, and prednisone 5 mg bid (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
88759|NCT02034552|P1|Participant Flow|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of National Institute of Standards and Technology (NIST) update) every 4 weeks x 6 doses IV (slow bolus).
88760|NCT02034552|O3|Outcome|Radium-223 With Enzalutamide|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus) and enzalutamide 160 mg daily (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
88761|NCT02034552|O2|Outcome|Radium-223 With Abiraterone & Prednision|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus), abiraterone acetate 1000 mg daily, and prednisone 5 mg bid (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
88762|NCT02034552|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of National Institute of Standards and Technology (NIST) update) every 4 weeks x 6 doses IV (slow bolus).
88763|NCT02034552|O3|Outcome|Radium-223 With Enzalutamide|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus) and enzalutamide 160 mg daily (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
88764|NCT02034552|O2|Outcome|Radium-223 With Abiraterone & Prednision|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus), abiraterone acetate 1000 mg daily, and prednisone 5 mg bid (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
88765|NCT02034552|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of National Institute of Standards and Technology (NIST) update) every 4 weeks x 6 doses IV (slow bolus).
88840|NCT02033499|O2|Outcome|SMBG Standard Messaging|Daily SMBG with standard messaging
88766|NCT02034552|O3|Outcome|Radium-223 With Enzalutamide|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus) and enzalutamide 160 mg daily (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
88767|NCT02034552|O2|Outcome|Radium-223 With Abiraterone & Prednision|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus), abiraterone acetate 1000 mg daily, and prednisone 5 mg bid (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
88768|NCT02034552|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of National Institute of Standards and Technology (NIST) update) every 4 weeks x 6 doses IV (slow bolus).
88769|NCT02034552|O3|Outcome|Radium-223 With Enzalutamide|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus) and enzalutamide 160 mg daily (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
88770|NCT02034552|O2|Outcome|Radium-223 With Abiraterone & Prednision|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus), abiraterone acetate 1000 mg daily, and prednisone 5 mg bid (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
88771|NCT02034552|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of National Institute of Standards and Technology (NIST) update) every 4 weeks x 6 doses IV (slow bolus).
88772|NCT02034552|O3|Outcome|Radium-223 With Enzalutamide|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus) and enzalutamide 160 mg daily (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
88773|NCT02034552|O2|Outcome|Radium-223 With Abiraterone & Prednision|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus), abiraterone acetate 1000 mg daily, and prednisone 5 mg bid (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
88774|NCT02034552|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of National Institute of Standards and Technology (NIST) update) every 4 weeks x 6 doses IV (slow bolus).
88775|NCT02034552|O3|Outcome|Radium-223 With Enzalutamide|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus) and enzalutamide 160 mg daily (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
88776|NCT02034552|O2|Outcome|Radium-223 With Abiraterone & Prednision|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus), abiraterone acetate 1000 mg daily, and prednisone 5 mg bid (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
88777|NCT02034552|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of National Institute of Standards and Technology (NIST) update) every 4 weeks x 6 doses IV (slow bolus).
88778|NCT02034552|E3|Reported Event|Radium-223 With Enzalutamide|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus) and enzalutamide 160 mg daily (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
88779|NCT02034552|E2|Reported Event|Radium-223 With Abiraterone & Prednision|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus), abiraterone acetate 1000 mg daily, and prednisone 5 mg bid (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
88780|NCT02034552|E1|Reported Event|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of National Institute of Standards and Technology (NIST) update) every 4 weeks x 6 doses IV (slow bolus).
88781|NCT02034513|B3|Baseline|Total|Total of all reporting groups
88782|NCT02034513|B2|Baseline|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar and IDeg were reduced by 20% at the start of both the treatment periods. Doses of IGlar and IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
88783|NCT02034513|B1|Baseline|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered s.c.in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg and IGlar were reduced by 20% at the start of both the treatment periods. Doses of IDeg and IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration fasting glycaemic target of 4.0-5.0 mmol/L).
88801|NCT02034162|B2|Baseline|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
88802|NCT02034162|B1|Baseline|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
88784|NCT02034513|P2|Participant Flow|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar and IDeg were reduced by 20% at the start of both the treatment periods. Doses of IGlar and IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
88785|NCT02034513|P1|Participant Flow|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received insulin degludec (IDeg) in treatment period 1 and insulin glargine (IGlar) in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered subcutaneously (s.c.; under the skin) in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken once daily (OD) at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg and IGlar were reduced by 20% at the start of both the treatment periods. Doses of IDeg and IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast self measured plasma glucose(SMPG) values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L)
88786|NCT02034513|O2|Outcome|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar and IDeg were reduced by 20% at the start of both the treatment periods. Doses of IGlar and IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
88787|NCT02034513|O1|Outcome|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered s.c.in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg and IGlar were reduced by 20% at the start of both the treatment periods. Doses of IDeg and IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration fasting glycaemic target of 4.0-5.0 mmol/L).
88788|NCT02034513|O2|Outcome|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar and IDeg were reduced by 20% at the start of both the treatment periods. Doses of IGlar and IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
88789|NCT02034513|O1|Outcome|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered s.c.in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg and IGlar were reduced by 20% at the start of both the treatment periods. Doses of IDeg and IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration fasting glycaemic target of 4.0-5.0 mmol/L).
88790|NCT02034513|O2|Outcome|Insulin Glargine (IGlar)|Subjects received IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar were reduced by 20% at the start of both the treatment periods. Doses of IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
88791|NCT02034513|O1|Outcome|Insulin Degludec (IDeg)|Subjects received IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg were reduced by 20% at the start of both the treatment periods. Doses of IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
88792|NCT02034513|O2|Outcome|Insulin Glargine (IGlar)|Subjects received IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar were reduced by 20% at the start of both the treatment periods. Doses of IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
88793|NCT02034513|O1|Outcome|Insulin Degludec (IDeg)|Subjects received IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg were reduced by 20% at the start of both the treatment periods. Doses of IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
88794|NCT02034513|O2|Outcome|Insulin Glargine (IGlar)|Subjects received IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar were reduced by 20% at the start of both the treatment periods. Doses of IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
88795|NCT02034513|O1|Outcome|Insulin Degludec (IDeg)|Subjects received IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg were reduced by 20% at the start of both the treatment periods. Doses of IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
88796|NCT02034513|O2|Outcome|Insulin Glargine (IGlar)|Subjects received IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar were reduced by 20% at the start of both the treatment periods. Doses of IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
88797|NCT02034513|O1|Outcome|Insulin Degludec (IDeg)|Subjects received IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg were reduced by 20% at the start of both the treatment periods. Doses of IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
88798|NCT02034513|E2|Reported Event|Insulin Glargine (IGlar)|Subjects received IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar were reduced by 20% at the start of both the treatment periods. Doses of IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
88799|NCT02034513|E1|Reported Event|Insulin Degludec (IDeg)|Subjects received IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg were reduced by 20% at the start of both the treatment periods. Doses of IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
88804|NCT02034162|P2|Participant Flow|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
88805|NCT02034162|P1|Participant Flow|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
88806|NCT02034162|O3|Outcome|Mebendazole: Group 3 (7 to 16 Years)|Group 3 represents pharmacokinetic analysis set which included participants with age group 7 to 16 years and received Mebendazole 500 mg.
88807|NCT02034162|O2|Outcome|Mebendazole: Group 2 (3 to 6 Years)|Group 2 represents pharmacokinetic analysis set which included participants with age group 3 to 6 years and received Mebendazole 500 mg.
88808|NCT02034162|O1|Outcome|Mebendazole: Group 1 (1 to <3 Years)|Group 1 represents pharmacokinetic analysis set which included participants with age group 1 to less than (<) 3 years and received Mebendazole 500 milligram (mg).
88809|NCT02034162|O3|Outcome|Mebendazole: Group 3 (7 to 16 Years)|Group 3 represents pharmacokinetic analysis set which included participants with age group 7 to 16 years and received Mebendazole 500 mg.
88810|NCT02034162|O2|Outcome|Mebendazole: Group 2 (3 to 6 Years)|Group 2 represents pharmacokinetic analysis set which included participants with age group 3 to 6 years and received Mebendazole 500 mg.
88811|NCT02034162|O1|Outcome|Mebendazole: Group 1 (1 to <3 Years)|Group 1 represents pharmacokinetic analysis set which included participants with age group 1 to less than (<) 3 years and received Mebendazole 500 milligram (mg).
88812|NCT02034162|O3|Outcome|Mebendazole: Group 3 (7 to 16 Years)|Group 3 represents pharmacokinetic analysis set which included participants with age group 7 to 16 years and received Mebendazole 500 mg.
88813|NCT02034162|O2|Outcome|Mebendazole: Group 2 (3 to 6 Years)|Group 2 represents pharmacokinetic analysis set which included participants with age group 3 to 6 years and received Mebendazole 500 mg.
88814|NCT02034162|O1|Outcome|Mebendazole: Group 1 (1 to <3 Years)|Group 1 represents pharmacokinetic analysis set which included participants with age group 1 to less than (<) 3 years and received Mebendazole 500 milligram (mg).
88815|NCT02034162|O1|Outcome|Open-label Mebendazole 500 mg|Mebendazole 500-mg chewable tablet was administered in an open label manner at visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3).
88816|NCT02034162|O3|Outcome|Mebendazole: Group 3 (7 to 16 Years)|Group 3 represents pharmacokinetic analysis set which included participants with age group 7 to 16 years and received Mebendazole 500 mg.
88817|NCT02034162|O2|Outcome|Mebendazole: Group 2 (3 to 6 Years)|Group 2 represents pharmacokinetic analysis set which included participants with age group 3 to 6 years and received Mebendazole 500 mg.
88818|NCT02034162|O1|Outcome|Mebendazole: Group 1 (1 to <3 Years)|Group 1 represents pharmacokinetic analysis set which included participants with age group 1 to less than (<) 3 years and received Mebendazole 500 milligram (mg).
88819|NCT02034162|O2|Outcome|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
88820|NCT02034162|O1|Outcome|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
88821|NCT02034162|O2|Outcome|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
88822|NCT02034162|O1|Outcome|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
88823|NCT02034162|O2|Outcome|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
88824|NCT02034162|O1|Outcome|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
88825|NCT02034162|O2|Outcome|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
88826|NCT02034162|O1|Outcome|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
88827|NCT02034162|O2|Outcome|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
88828|NCT02034162|O1|Outcome|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
88829|NCT02034162|E3|Reported Event|OL Mebendazole 500 mg|Mebendazole 500-mg chewable tablet was administered in an open label manner at visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3).
88830|NCT02034162|E2|Reported Event|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
88831|NCT02034162|E1|Reported Event|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
88832|NCT02033499|B4|Baseline|Total|Total of all reporting groups
88833|NCT02033499|B3|Baseline|SMBG Enhanced Messaging|Daily SMBG with enhanced messaging
88834|NCT02033499|B2|Baseline|SMBG Standard Messaging|Daily SMBG with standard messaging
88835|NCT02033499|B1|Baseline|No Testing|No SMBG testing
88836|NCT02033499|P3|Participant Flow|SMBG Enhanced Messaging|Daily SMBG with enhanced messaging
88837|NCT02033499|P2|Participant Flow|SMBG Standard Messaging|Daily SMBG with standard messaging
88838|NCT02033499|P1|Participant Flow|No Testing|No SMBG testing
88839|NCT02033499|O3|Outcome|SMBG Enhanced Messaging|Daily SMBG with enhanced messaging
88842|NCT02033499|O3|Outcome|SMBG Enhanced Messaging|Daily SMBG with enhanced messaging
88843|NCT02033499|O2|Outcome|SMBG Standard Messaging|Daily SMBG with standard messaging
88844|NCT02033499|O1|Outcome|No Testing|No SMBG testing
88845|NCT02033499|O3|Outcome|SMBG Enhanced Messaging|Daily SMBG with enhanced messaging
88846|NCT02033499|O2|Outcome|SMBG Standard Messaging|Daily SMBG with standard messaging
88847|NCT02033499|O1|Outcome|No Testing|No SMBG testing
88848|NCT02033499|O3|Outcome|SMBG Enhanced Messaging|Daily SMBG with enhanced messaging
88849|NCT02033499|O2|Outcome|SMBG Standard Messaging|Daily SMBG with standard messaging
88850|NCT02033499|O1|Outcome|No Testing|No SMBG testing
88851|NCT02033499|O3|Outcome|SMBG Enhanced Messaging|Daily SMBG with enhanced messaging
88852|NCT02033499|O2|Outcome|SMBG Standard Messaging|Daily SMBG with standard messaging
88853|NCT02033499|O1|Outcome|No Testing|No SMBG testing
88854|NCT02033499|O3|Outcome|SMBG Enhanced Messaging|Daily SMBG with enhanced messaging
88855|NCT02033499|O2|Outcome|SMBG Standard Messaging|Daily SMBG with standard messaging
88856|NCT02033499|O1|Outcome|No Testing|No SMBG testing
88857|NCT02033499|O3|Outcome|SMBG Enhanced Messaging|Daily SMBG with enhanced messaging
88858|NCT02033499|O2|Outcome|SMBG Standard Messaging|Daily SMBG with standard messaging
88859|NCT02033499|O1|Outcome|No Testing|No SMBG testing
88860|NCT02033499|O3|Outcome|SMBG Enhanced Messaging|Daily SMBG with enhanced messaging
88861|NCT02033499|O2|Outcome|SMBG Standard Messaging|Daily SMBG with standard messaging
88862|NCT02033499|O1|Outcome|No Testing|No SMBG testing
88863|NCT02033499|O3|Outcome|SMBG Enhanced Messaging|Daily SMBG with enhanced messaging
88864|NCT02033499|O2|Outcome|SMBG Standard Messaging|Daily SMBG with standard messaging
88865|NCT02033499|O1|Outcome|No Testing|No SMBG testing
88866|NCT02033499|O3|Outcome|SMBG Enhanced Messaging|Daily SMBG with enhanced messaging
88867|NCT02033499|O2|Outcome|SMBG Standard Messaging|Daily SMBG with standard messaging
88868|NCT02033499|O1|Outcome|No Testing|No SMBG testing
88869|NCT02033499|O3|Outcome|SMBG Enhanced Messaging|Daily SMBG with enhanced messaging
88870|NCT02033499|O2|Outcome|SMBG Standard Messaging|Daily SMBG with standard messaging
88871|NCT02033499|O1|Outcome|No Testing|No Self-Monitoring of Blood Glucose (SMBG) testing
88872|NCT02033499|E3|Reported Event|SMBG Enhanced Messaging|Daily SMBG with enhanced messaging
88873|NCT02033499|E2|Reported Event|SMBG Standard Messaging|Daily SMBG with standard messaging
88874|NCT02033499|E1|Reported Event|No Testing|No SMBG testing
88875|NCT02033369|B3|Baseline|Total|Total of all reporting groups
88876|NCT02033369|B2|Baseline|Healthy Control Patients|Healthy control patients did not receive study medication and only have baseline measures.
88877|NCT02033369|B1|Baseline|MDD Patients|"Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.~Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 – 2.5 mg/day"
88878|NCT02033369|P2|Participant Flow|Healthy Controls|Individuals without depression
88879|NCT02033369|P1|Participant Flow|MDD Patients|"Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.~Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 – 2.5 mg/day"
88880|NCT02033369|O1|Outcome|Pramipexole|"Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.~Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 – 2.5 mg/day"
88881|NCT02033369|O1|Outcome|Pramipexole|"Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.~Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 – 2.5 mg/day"
88882|NCT02033369|O1|Outcome|Pramipexole|"Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.~Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 – 2.5 mg/day"
88883|NCT02033369|O1|Outcome|Pramipexole|"Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.~Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 – 2.5 mg/day"
88884|NCT02033369|O1|Outcome|Pramipexole|"Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.~Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 – 2.5 mg/day"
88885|NCT02033369|O1|Outcome|Pramipexole|"Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.~Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 – 2.5 mg/day"
88886|NCT02033369|O1|Outcome|Pramipexole|"Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.~Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 – 2.5 mg/day"
88887|NCT02033369|E1|Reported Event|MDD Patients|Only patients with MDD received treatment. There was only one arm.
88888|NCT02033317|B1|Baseline|Patiromer|15 grams/day (5 grams 3 times daily) patiromer administered orally
88889|NCT02033317|P1|Participant Flow|Patiromer|15 grams/day (5 grams 3 times daily) patiromer administered orally
88890|NCT02033317|O1|Outcome|Patiromer|15 grams/day (5 grams 3 times daily) patiromer administered orally
88891|NCT02033317|O1|Outcome|Patiromer|15 grams/day (5 grams 3 times daily) patiromer administered orally
88892|NCT02033317|E1|Reported Event|Patiromer|15 grams/day (5 grams 3 times daily) patiromer administered orally.
88893|NCT02033213|B3|Baseline|Total|Total of all reporting groups
88973|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
88894|NCT02033213|B2|Baseline|Liberal Group|"Liberal group: A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
88895|NCT02033213|B1|Baseline|Restrictive Group|"Restrictive group: A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
88896|NCT02033213|P2|Participant Flow|Liberal Group|"Liberal group: A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
88897|NCT02033213|P1|Participant Flow|Restrictive Group|"Restrictive group: A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
88898|NCT02033213|O2|Outcome|Liberal Group|"Patients who received > 8 ml/kg/h of fluid. A fluid used during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.~Liberal group: A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
88899|NCT02033213|O1|Outcome|Restrictive Group|"Patients who received ≤ 8ml/kg/h of intraoperative fluid. A fluid administered during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.~Restrictive group: A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
88900|NCT02033213|O2|Outcome|Liberal Group|"Patients who received > 8 ml/kg/h of fluid. A fluid used during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.~Liberal group: A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
88901|NCT02033213|O1|Outcome|Restrictive Group|"Patients who received ≤ 8ml/kg/h of intraoperative fluid. A fluid administered during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.~Restrictive group: A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
88902|NCT02033213|O2|Outcome|Liberal Group|"A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
88903|NCT02033213|O1|Outcome|Restrictive Group|"A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
88904|NCT02033213|O2|Outcome|Liberal Group|"A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
88905|NCT02033213|O1|Outcome|Restrictive Group|"A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
88906|NCT02033213|O2|Outcome|Liberal Group|"A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
88907|NCT02033213|O1|Outcome|Restrictive Group|"A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
88908|NCT02033213|O2|Outcome|Liberal Group|"A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
88974|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
88909|NCT02033213|O1|Outcome|Restrictive Group|"A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
88910|NCT02033213|E2|Reported Event|Liberal Group|"A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
88911|NCT02033213|E1|Reported Event|Restrictive Group|"A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
88912|NCT02033200|B3|Baseline|Total|Total of all reporting groups
88913|NCT02033200|B2|Baseline|Placebo|placebo
88914|NCT02033200|B1|Baseline|Active|Stendra 200 mg
88915|NCT02033200|P2|Participant Flow|Placebo|placebo
88916|NCT02033200|P1|Participant Flow|Active|Stendra 200 mg
88917|NCT02033200|O2|Outcome|Placebo|placebo
88918|NCT02033200|O1|Outcome|Active|Stendra 200 mg
88919|NCT02033200|O2|Outcome|Placebo|placebo
88920|NCT02033200|O1|Outcome|Active|Stendra 200 mg
88921|NCT02033200|O2|Outcome|Placebo|placebo
88922|NCT02033200|O1|Outcome|Active|Stendra 200 mg
88923|NCT02033200|O2|Outcome|Placebo|placebo
88924|NCT02033200|O1|Outcome|Active|Stendra 200 mg
88925|NCT02033200|O2|Outcome|Placebo|placebo
88926|NCT02033200|O1|Outcome|Active|Stendra 200 mg
88927|NCT02033200|O2|Outcome|Placebo|placebo
88928|NCT02033200|O1|Outcome|Active|Stendra 200 mg
88929|NCT02033200|O2|Outcome|Placebo|placebo
88930|NCT02033200|O1|Outcome|Active|Stendra 200 mg
88931|NCT02033200|O2|Outcome|Placebo|placebo
88932|NCT02033200|O1|Outcome|Active|Stendra 200 mg
88933|NCT02033200|E2|Reported Event|Placebo|placebo
88934|NCT02033200|E1|Reported Event|Active|Stendra 200 mg
88935|NCT02033174|B1|Baseline|All Participants|Cross over study over five different weeks. Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat. In all cases, alcohol represented a daily total amount of 16 g/m2. The content of alcohol was 12% in red wine, 37% in rum, and 35% in brandy.Vodka was tri-distilled and contained 40% alcohol.
88936|NCT02033174|P2|Participant Flow|Sugar Water First ,Then Alcohol|Participants first received an oral fat-enriched diet (1486 kcal/m2) and sugar with water for 5 days. They then received a daily total amount of 16 g/m2 of alcohol, of different beverages (red wine, vodka, brandy or rum) for 5 days.
88937|NCT02033174|P1|Participant Flow|Alcohol First, Then Sugar Water|Participants first received an oral fat-enriched diet (1486 kcal/m2) and a daily total amount of 16 g/m2 of alcohol, of different beverages (red wine, vodka, brandy or rum) for 5 days. Then, they received equivalent caloric intakes as sugar with water in the control group for 5 days.
88938|NCT02033174|O2|Outcome|Oral Fat Diet|The fat-enriched diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat.
88939|NCT02033174|O1|Outcome|Alcoholic Beverages (Red Wine Intake)|Cross over study over five different weeks. Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat. In all cases, alcohol represented a daily total amount of 16 g/m2. The content of alcohol was 12% in red wine
88940|NCT02033174|E2|Reported Event|Oral Fat Diet|Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat.
88941|NCT02033174|E1|Reported Event|Alcoholic Beverages|Cross over study over five different weeks. Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat. In all cases, alcohol represented a daily total amount of 16 g/m2. The content of alcohol was 12% in red wine, 37% in rum, and 35% in brandy.Vodka was tri-distilled and contained 40% alcohol.
88942|NCT02032901|B3|Baseline|Total|Total of all reporting groups
88943|NCT02032901|B2|Baseline|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
88944|NCT02032901|B1|Baseline|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
88945|NCT02032901|P2|Participant Flow|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
88946|NCT02032901|P1|Participant Flow|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
88947|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
88948|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
88949|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with HCV genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
88950|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
88951|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
88952|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
88953|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
88954|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
88955|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
88956|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
88957|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
88958|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with HCV genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
88959|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
88960|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
88961|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
88962|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
88963|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
88964|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
88965|NCT02032901|E1|Reported Event|Daclatasvir + Sofosbuvir|All participants infected with hepatitis C virus (HCV) genotype-3 received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks during the study.
88966|NCT02032888|B4|Baseline|Total|Total of all reporting groups
88967|NCT02032888|B3|Baseline|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
88968|NCT02032888|B2|Baseline|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
88969|NCT02032888|B1|Baseline|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus (HCV) treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
88970|NCT02032888|P3|Participant Flow|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
88971|NCT02032888|P2|Participant Flow|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
88972|NCT02032888|P1|Participant Flow|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus (HCV)treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily, for 12 weeks of treatment and 24 weeks of follow-up.
89126|NCT02032212|O4|Outcome|Conventional Cigarette|Conventional cigarette (commercially available)
88975|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
88976|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
88977|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
88978|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
88979|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
88980|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
88981|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
88982|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvi,r 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
88983|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
88984|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus (HCV) treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
88985|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
88986|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
88987|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
88988|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
88989|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
88990|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
88991|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior HCV treatment received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
88992|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior HCV treatment received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
88993|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus (HCV)treatment received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
88994|NCT02032888|O1|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
88995|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
88996|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
88997|NCT02032888|E3|Reported Event|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
88998|NCT02032888|E2|Reported Event|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
88999|NCT02032888|E1|Reported Event|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
89000|NCT02032875|B3|Baseline|Total|Total of all reporting groups
89001|NCT02032875|B2|Baseline|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
89002|NCT02032875|B1|Baseline|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
89127|NCT02032212|O3|Outcome|Nicotine Inhalator|Nicotine inhalator 15mg
89003|NCT02032875|P2|Participant Flow|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
89004|NCT02032875|P1|Participant Flow|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
89005|NCT02032875|O2|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
89006|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
89007|NCT02032875|O2|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
89008|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
89009|NCT02032875|O2|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
89010|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
89011|NCT02032875|O2|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
89012|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
89013|NCT02032875|O2|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
89014|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
89015|NCT02032875|O2|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
89016|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
89017|NCT02032875|O1|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
89018|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
89019|NCT02032875|E2|Reported Event|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
89020|NCT02032875|E1|Reported Event|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
89021|NCT02032758|B3|Baseline|Total|Total of all reporting groups
89022|NCT02032758|B2|Baseline|Golf Pros|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.
89023|NCT02032758|B1|Baseline|Golfers With Golfer's Cramp|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.
89128|NCT02032212|O2|Outcome|EVP Flavoured|Flavoured e-vapour product
89129|NCT02032212|O1|Outcome|EVP Unflavoured|Unflavoured e-vapour product
89024|NCT02032758|P2|Participant Flow|Golf Pros|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.
89025|NCT02032758|P1|Participant Flow|Golfers With Golfer's Cramp|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.
89026|NCT02032758|O2|Outcome|Golf Pros|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.
89027|NCT02032758|O1|Outcome|Golfers With Golfer's Cramp|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.
89028|NCT02032758|O2|Outcome|Golf Pros|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.
89029|NCT02032758|O1|Outcome|Golfers With Golfer's Cramp|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.
89030|NCT02032758|E2|Reported Event|Golf Pros|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.
89031|NCT02032758|E1|Reported Event|Golfers With Golfer's Cramp|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.
89032|NCT02032706|B1|Baseline|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
89033|NCT02032706|P1|Participant Flow|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
89034|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
89035|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
89036|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
89037|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
89038|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
89039|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
89040|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
89041|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
89042|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
89043|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
89044|NCT02032706|E1|Reported Event|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
89045|NCT02032641|B1|Baseline|Laser Treatment and Control Group|"Each patient was randomized to have one of two scars treated with Laser Genesis and a scar not treated with Laser Genesis, which was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study. The laser treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was too hot as an additional safeguard against epidermal damage.~Laser treatment: Non-ablative, non-fractional, microsecond-pulsed Neodymium:Yttrium/Aluminum/Garnet laser 500-1000 pulses, 0.3 msec pulse duration, 10-14 J/cm2, 5 mm spot size"
89076|NCT02032420|B1|Baseline|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
89077|NCT02032420|P2|Participant Flow|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
89078|NCT02032420|P1|Participant Flow|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
89079|NCT02032420|O2|Outcome|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
89046|NCT02032641|P1|Participant Flow|Laser Treatment and Control Group|"Each patient was randomized to have one of two scars treated with Laser Genesis and a scar not treated with Laser Genesis, which was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study. The laser treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was too hot as an additional safeguard against epidermal damage.~Laser treatment: Non-ablative, non-fractional, microsecond-pulsed Neodymium:Yttrium/Aluminum/Garnet laser 500-1000 pulses, 0.3 msec pulse duration, 10-14 J/cm2, 5 mm spot size"
89047|NCT02032641|O2|Outcome|Control Scar|Each patient had a scar which was randomized to not undergo treatments with Laser Genesis, and was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study.
89048|NCT02032641|O1|Outcome|Laser Treatment Side|"Each patient was randomized to have one of two scars treated with Laser Genesis. The treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was too hot as an additional safeguard against epidermal damage."
89049|NCT02032641|O2|Outcome|Control Scar|Each patient had a scar which was randomized to not undergo treatments with Laser Genesis, and was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study.
89050|NCT02032641|O1|Outcome|Laser Treatment Side|"Each patient was randomized to have one of two scars treated with Laser Genesis. The treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was too hot as an additional safeguard against epidermal damage."
89051|NCT02032641|O2|Outcome|Control Scar|Each patient had a scar which was randomized to not undergo treatments with Laser Genesis, and was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study.
89052|NCT02032641|O1|Outcome|Laser Treatment Side|"Each patient was randomized to have one of two scars treated with Laser Genesis. The treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was too hot as an additional safeguard against epidermal damage."
89053|NCT02032641|E2|Reported Event|Laser Left, Non-laser RIght|Group which had the right post-operative scar assigned to receive laser treatment
89054|NCT02032641|E1|Reported Event|Laser Right, Non-laser Left|Group which had the right post-operative scar assigned to receive laser treatment
89055|NCT02032433|B3|Baseline|Total|Total of all reporting groups
89056|NCT02032433|B2|Baseline|Buprenorphine-Naloxone|"Buprenorphine-Naloxone (Suboxone)~Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)"
89057|NCT02032433|B1|Baseline|Extended-Release Naltrexone|"Extended-Release Naltrexone (Vivitrol)~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)"
89058|NCT02032433|P2|Participant Flow|Buprenorphine-Naloxone|"Buprenorphine-Naloxone (Suboxone)~Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)"
89059|NCT02032433|P1|Participant Flow|Extended-Release Naltrexone|"Extended-Release Naltrexone (Vivitrol)~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)"
89060|NCT02032433|O2|Outcome|Buprenorphine-Naloxone|"Buprenorphine-Naloxone (Suboxone)~Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)"
89061|NCT02032433|O1|Outcome|Extended-Release Naltrexone|"Extended-Release Naltrexone (Vivitrol)~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)"
89062|NCT02032433|O2|Outcome|Buprenorphine-Naloxone|"Buprenorphine-Naloxone (Suboxone)~Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)"
89063|NCT02032433|O1|Outcome|Extended-Release Naltrexone|"Extended-Release Naltrexone (Vivitrol)~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)"
89064|NCT02032433|O2|Outcome|Buprenorphine-Naloxone|"Buprenorphine-Naloxone (Suboxone)~Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)"
89065|NCT02032433|O1|Outcome|Extended-Release Naltrexone|"Extended-Release Naltrexone (Vivitrol)~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)"
89066|NCT02032433|O2|Outcome|Buprenorphine-Naloxone|"Buprenorphine-Naloxone (Suboxone)~Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)"
89067|NCT02032433|O1|Outcome|Extended-Release Naltrexone|"Extended-Release Naltrexone (Vivitrol)~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)"
89068|NCT02032433|O2|Outcome|Buprenorphine-Naloxone|"Buprenorphine-Naloxone (Suboxone)~Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)"
89069|NCT02032433|O1|Outcome|Extended-Release Naltrexone|"Extended-Release Naltrexone (Vivitrol)~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)"
89070|NCT02032433|O2|Outcome|Buprenorphine-Naloxone|"Buprenorphine-Naloxone (Suboxone)~Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)"
89071|NCT02032433|O1|Outcome|Extended-Release Naltrexone|"Extended-Release Naltrexone (Vivitrol)~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)"
89072|NCT02032433|E2|Reported Event|Buprenorphine-Naloxone|"Buprenorphine-Naloxone (Suboxone)~Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)"
89073|NCT02032433|E1|Reported Event|Extended-Release Naltrexone|"Extended-Release Naltrexone (Vivitrol)~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)"
89074|NCT02032420|B3|Baseline|Total|Total of all reporting groups
89075|NCT02032420|B2|Baseline|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
89080|NCT02032420|O1|Outcome|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
89081|NCT02032420|O2|Outcome|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
89082|NCT02032420|O1|Outcome|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
89083|NCT02032420|O2|Outcome|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
89084|NCT02032420|O1|Outcome|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
89085|NCT02032420|O2|Outcome|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
89086|NCT02032420|O1|Outcome|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
89087|NCT02032420|E2|Reported Event|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
89088|NCT02032420|E1|Reported Event|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
89089|NCT02032407|B1|Baseline|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
89090|NCT02032407|P1|Participant Flow|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
89091|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
89092|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
89093|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
89094|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
89095|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
89096|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
89097|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
89098|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
89099|NCT02032407|E1|Reported Event|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
89100|NCT02032238|B3|Baseline|Total|Total of all reporting groups
89101|NCT02032238|B2|Baseline|Monotherapy|"patients receive Anti-VEGF Monotherapy~Anti-VEGF Injections: Monotherapy"
89102|NCT02032238|B1|Baseline|Combination With Navigated Laser|"Combining photocoagulation and Anti-VEGF Injections in a pre-defined manner~Navigated laser: Standard Anti-VEGF Injections will be combined with Navigated laser in a pre-defined manner~Anti-VEGF Injections: Monotherapy"
89103|NCT02032238|P2|Participant Flow|Bevacizumab, no Laser Photocoagulation|patients receive Anti-VEGF injections (Bevacizumab) only
89104|NCT02032238|P1|Participant Flow|Laser Photocoagulation With Bevacizumab|Combining laser photocoagulation and Anti-VEGF Injections in a pre-defined manner
89105|NCT02032238|O2|Outcome|Monotherapy|"patients receive Anti-VEGF Monotherapy~Anti-VEGF Injections: Monotherapy"
89106|NCT02032238|O1|Outcome|Combination With Navigated Laser|"Combining photocoagulation and Anti-VEGF Injections in a pre-defined manner~Navigated laser: Standard Anti-VEGF Injections will be combined with Navigated laser in a pre-defined manner~Anti-VEGF Injections: Monotherapy"
89107|NCT02032238|E2|Reported Event|Bevacizumab, no Laser Photocoagulation|patients receive Anti-VEGF injections (Bevacizumab) only
89108|NCT02032238|E1|Reported Event|Laser Photocoagulation With Bevacizumab|Combining laser photocoagulation and Anti-VEGF Injections in a pre-defined manner
89109|NCT02032212|B5|Baseline|Total|Total of all reporting groups
89110|NCT02032212|B4|Baseline|Sequence 4|Subjects in this arm used the conventional cigarette on Day 1, the Nicotine inhalator on Day 2, the flavoured EVP on Day 3, the unflavoured EVP on Day 4.
89111|NCT02032212|B3|Baseline|Sequence 3|Subjects in this arm used the Nicotine inhalator on Day 1 and the conventional cigarette on Day 2, the unflavoured EVP on Day 3 and the flavoured EVP on Day 4.
89112|NCT02032212|B2|Baseline|Sequence 2|Subjects in this arm used the flavoured EVP on Day 1, the unflavoured EVP on Day 2, the conventional cigarette on Day 3 and the Nicotine inhalator on Day 4.
89113|NCT02032212|B1|Baseline|Sequence 1|Subjects in this arm used the unflavoured EVP on Day 1, the flavoured EVP on Day 2, Nicotine inhalator on Day 3 and the conventional cigarette on Day 4.
89114|NCT02032212|P4|Participant Flow|Sequence 4|Subjects in this arm used the conventional cigarette on Day 1, the nicotine inhalator on Day 2, the flavoured EVP on Day 3 and the unflavoured EVP on Day 4.
89115|NCT02032212|P3|Participant Flow|Sequence 3|Subjects in this arm used the nicotine inhalator on Day 1, the conventional cigarette on Day 2, the unflavoured EVP on Day 3 and the flavoured EVP on Day 4.
89116|NCT02032212|P2|Participant Flow|Sequence 2|Subjects in this arm used the flavoured EVP on Day 1, the unflavoured EVP on Day 2, the conventional cigarette on Day 3 and the nicotine inhalator on Day 4.
89117|NCT02032212|P1|Participant Flow|Sequence 1|Subjects in this arm used the unflavoured EVP on Day 1, the flavoured EVP on Day 2, Nicotine inhalator on Day 3 and the conventional cigarette on Day 4.
89118|NCT02032212|O4|Outcome|Conventional Cigarette|Conventional cigarette (commercially available)
89119|NCT02032212|O3|Outcome|Nicotine Inhalator|Nicotine inhalator 15mg
89120|NCT02032212|O2|Outcome|EVP Flavoured|Flavoured e-vapour product
89121|NCT02032212|O1|Outcome|EVP Unflavoured|Unflavoured e-vapour product
89122|NCT02032212|O4|Outcome|Conventional Cigarette|Conventional cigarette (commercially available)
89123|NCT02032212|O3|Outcome|Nicotine Inhalator|Nicotine inhalator 15mg
89124|NCT02032212|O2|Outcome|EVP Flavoured|Flavoured e-vapour product
89125|NCT02032212|O1|Outcome|EVP Unflavoured|Unflavoured e-vapour product
89130|NCT02032212|O4|Outcome|Conventional Cigarette|Conventional cigarette (commercially available)
89131|NCT02032212|O3|Outcome|Nicotine Inhalator|Nicotine inhalator 15mg
89132|NCT02032212|O2|Outcome|EVP Flavoured|Flavoured e-vapour product
89133|NCT02032212|O1|Outcome|EVP Unflavoured|Unflavoured e-vapour product
89134|NCT02032212|O4|Outcome|Conventional Cigarette|Conventional cigarette (commercially available)
89135|NCT02032212|O3|Outcome|Nicotine Inhalator|Nicotine inhalator 15mg
89136|NCT02032212|O2|Outcome|EVP Flavoured|Flavoured e-vapour product
89137|NCT02032212|O1|Outcome|EVP Unflavoured|Unflavoured e-vapour product
89138|NCT02032212|E4|Reported Event|Conventional Cigarette|Conventional cigarette (commercially available)
89139|NCT02032212|E3|Reported Event|Nicotine Inhalator|Nicotine inhalator 15mg
89140|NCT02032212|E2|Reported Event|EVP Flavoured|Flavoured e-vapour product
89141|NCT02032212|E1|Reported Event|EVP Unflavoured|Unflavoured e-vapour product
89142|NCT02031679|B3|Baseline|Total|Total of all reporting groups
89143|NCT02031679|B2|Baseline|Placebo|"The placebo will be available in tablet form. The placebo contains the same ingredients as the AZD1981 with the exception of the active compound.~The placebo will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.~The tablets should be swallowed whole with a glass of water.~Placebo: Sugar pill manufactured to mimic AZD1981 10 mg tablet"
89144|NCT02031679|B1|Baseline|AZD1981|"AZD1981 for oral administration will be available in tablet form. AZD1981 tablets will be provided in 10 mg strengths.~The drug will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.~The tablets should be swallowed whole with a glass of water.~AZD1981: AZD1981 is an oral, potent, selective, reversible antagonist of CRTh2 (Chemoattractant Receptor Homologous Molecule expressed on Th2 cells)."
89145|NCT02031679|P2|Participant Flow|Placebo|"The placebo will be available in tablet form. The placebo contains the same ingredients as the AZD1981 with the exception of the active compound.~The placebo will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.~The tablets should be swallowed whole with a glass of water.~Placebo: Sugar pill manufactured to mimic AZD1981 10 mg tablet"
89146|NCT02031679|P1|Participant Flow|AZD1981|"AZD1981 for oral administration will be available in tablet form. AZD1981 tablets will be provided in 10 mg strengths.~The drug will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.~The tablets should be swallowed whole with a glass of water.~AZD1981: AZD1981 is an oral, potent, selective, reversible antagonist of CRTh2 (Chemoattractant Receptor Homologous Molecule expressed on Th2 cells)."
89147|NCT02031679|O2|Outcome|Placebo|"The placebo will be available in tablet form. The placebo contains the same ingredients as the AZD1981 with the exception of the active compound.~The placebo will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.~The tablets should be swallowed whole with a glass of water.~Placebo: Sugar pill manufactured to mimic AZD1981 10 mg tablet"
89148|NCT02031679|O1|Outcome|AZD1981|"AZD1981 for oral administration will be available in tablet form. AZD1981 tablets will be provided in 10 mg strengths.~The drug will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.~The tablets should be swallowed whole with a glass of water.~AZD1981: AZD1981 is an oral, potent, selective, reversible antagonist of CRTh2 (Chemoattractant Receptor Homologous Molecule expressed on Th2 cells)."
89149|NCT02031679|O2|Outcome|Placebo|"The placebo will be available in tablet form. The placebo contains the same ingredients as the AZD1981 with the exception of the active compound.~The placebo will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.~The tablets should be swallowed whole with a glass of water.~Placebo: Sugar pill manufactured to mimic AZD1981 10 mg tablet"
89150|NCT02031679|O1|Outcome|AZD1981|"AZD1981 for oral administration will be available in tablet form. AZD1981 tablets will be provided in 10 mg strengths.~The drug will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.~The tablets should be swallowed whole with a glass of water.~AZD1981: AZD1981 is an oral, potent, selective, reversible antagonist of CRTh2 (Chemoattractant Receptor Homologous Molecule expressed on Th2 cells)."
89151|NCT02031679|O2|Outcome|Placebo|"The placebo will be available in tablet form. The placebo contains the same ingredients as the AZD1981 with the exception of the active compound.~The placebo will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.~The tablets should be swallowed whole with a glass of water.~Placebo: Sugar pill manufactured to mimic AZD1981 10 mg tablet"
89152|NCT02031679|O1|Outcome|AZD1981|"AZD1981 for oral administration will be available in tablet form. AZD1981 tablets will be provided in 10 mg strengths.~The drug will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.~The tablets should be swallowed whole with a glass of water.~AZD1981: AZD1981 is an oral, potent, selective, reversible antagonist of CRTh2 (Chemoattractant Receptor Homologous Molecule expressed on Th2 cells)."
89153|NCT02031679|E2|Reported Event|Placebo|"The placebo will be available in tablet form. The placebo contains the same ingredients as the AZD1981 with the exception of the active compound.~The placebo will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.~The tablets should be swallowed whole with a glass of water.~Placebo: Sugar pill manufactured to mimic AZD1981 10 mg tablet"
89154|NCT02031679|E1|Reported Event|AZD1981|"AZD1981 for oral administration will be available in tablet form. AZD1981 tablets will be provided in 10 mg strengths.~The drug will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.~The tablets should be swallowed whole with a glass of water.~AZD1981: AZD1981 is an oral, potent, selective, reversible antagonist of CRTh2 (Chemoattractant Receptor Homologous Molecule expressed on Th2 cells)."
89155|NCT02031640|B6|Baseline|Total|Total of all reporting groups
89561|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89156|NCT02031640|B5|Baseline|BDP 640 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.~Placebo BAI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89157|NCT02031640|B4|Baseline|BDP 320 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.~Placebo BAI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89158|NCT02031640|B3|Baseline|BDP 640 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding.~Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89159|NCT02031640|B2|Baseline|BDP 320 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89160|NCT02031640|B1|Baseline|Placebo BAI and MDI|"Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89161|NCT02031640|P6|Participant Flow|BDP 640 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.~Placebo BAI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms."
89162|NCT02031640|P5|Participant Flow|BDP 320 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.~Placebo BAI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms."
89163|NCT02031640|P4|Participant Flow|BDP 640 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms."
89164|NCT02031640|P3|Participant Flow|BDP 320 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms."
89165|NCT02031640|P2|Participant Flow|Placebo BAI and MDI|"Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms."
89166|NCT02031640|P1|Participant Flow|Consented Patients - Standard ICS and Placebo|"Consented patients were placed on a standard inhaled corticosteroids (ICS) of fluticasone propionate through the Screening and Run-In Periods. The assigned total daily dose was 440 mcg/day or 880 mcg/day dependent upon prestudy asthma treatment.~In addition to standard ICS, participants were provided with single-blind placebo BAI and single-blind placebo MDI device for twice-daily use during the Run-In period.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms"
89167|NCT02031640|O5|Outcome|BDP 640 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.~Placebo BAI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89168|NCT02031640|O4|Outcome|BDP 320 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.~Placebo BAI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89169|NCT02031640|O3|Outcome|BDP 640 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89170|NCT02031640|O2|Outcome|BDP 320 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89171|NCT02031640|O1|Outcome|Placebo BAI or MDI|"Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89172|NCT02031640|O5|Outcome|BDP 640 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.~Placebo BAI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89173|NCT02031640|O4|Outcome|BDP 320 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.~Placebo BAI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89174|NCT02031640|O3|Outcome|BDP 640 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89175|NCT02031640|O2|Outcome|BDP 320 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89176|NCT02031640|O1|Outcome|Placebo BAI or MDI|"Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89177|NCT02031640|O5|Outcome|BDP 640 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.~Placebo BAI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89178|NCT02031640|O4|Outcome|BDP 320 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.~Placebo BAI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89179|NCT02031640|O3|Outcome|BDP 640 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89180|NCT02031640|O2|Outcome|BDP 320 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89181|NCT02031640|O1|Outcome|Placebo BAI and MDI|"Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89182|NCT02031640|O5|Outcome|BDP 640 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.~Placebo BAI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89183|NCT02031640|O4|Outcome|BDP 320 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.~Placebo BAI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89184|NCT02031640|O3|Outcome|BDP 640 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89185|NCT02031640|O2|Outcome|BDP 320 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89186|NCT02031640|O1|Outcome|Placebo BAI and MDI|"Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89187|NCT02031640|O5|Outcome|BDP 640 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.~Placebo BAI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89188|NCT02031640|O4|Outcome|BDP 320 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.~Placebo BAI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89189|NCT02031640|O3|Outcome|BDP 640 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89190|NCT02031640|O2|Outcome|BDP 320 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89191|NCT02031640|O1|Outcome|Placebo BAI and MDI|"Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89192|NCT02031640|O5|Outcome|BDP 640 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.~Placebo BAI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89193|NCT02031640|O4|Outcome|BDP 320 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.~Placebo BAI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89194|NCT02031640|O3|Outcome|BDP 640 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89195|NCT02031640|O2|Outcome|BDP 320 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding.~Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89870|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89196|NCT02031640|O1|Outcome|Placebo BAI and MDI|"Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89197|NCT02031640|O5|Outcome|BDP 640 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.~Placebo BAI for blinding.~Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89198|NCT02031640|O4|Outcome|BDP 320 mcg MDI|"Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.~Placebo BAI for blinding.~Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89199|NCT02031640|O3|Outcome|BDP 640 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding.~Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89200|NCT02031640|O2|Outcome|BDP 320 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding.~Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89201|NCT02031640|O1|Outcome|Placebo BAI and MDI|"Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.~Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period."
89202|NCT02031640|E6|Reported Event|Run-in Period Experience for Randomized Participants|Experience of randomized participants during the Run-In Period when they were administered standard ICS (fluticasone propionate) as well as single-blind placebo BAI and single-blind placebo MDI devices for twice-daily use.
89203|NCT02031640|E5|Reported Event|Placebo BAI and MDI|"Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.~Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms."
89204|NCT02031640|E4|Reported Event|MDI 640 mcg/Day|Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily. Placebo BAI for blinding. Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms.
89205|NCT02031640|E3|Reported Event|MDI 320 mcg/Day|Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily. Placebo BAI for blinding. Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms.
89206|NCT02031640|E2|Reported Event|BAI 640 mcg/Day|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding. Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms."
89207|NCT02031640|E1|Reported Event|BDP 320 mcg BAI|"Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.~Placebo MDI for blinding. Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms."
89208|NCT02031471|B1|Baseline|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89209|NCT02031471|P1|Participant Flow|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the long term extension (LTE) period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. Participants entered 8 weeks of follow-up either at the end of the 24-week open-label core study or after completion of the LTE. A fixed dose of 162 milligram (mg) tocilizumab was administered subcutaneously once weekly.
89210|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89211|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89212|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89213|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89214|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89871|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89215|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89216|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89217|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89218|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89219|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89220|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89221|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89222|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89223|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89224|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89225|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89226|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89227|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89228|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89229|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89230|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89231|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89232|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
90188|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
89233|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89234|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89235|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89236|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
89237|NCT02031471|E1|Reported Event|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the long term extension (LTE) period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 milligram (mg) tocilizumab was administered subcutaneously once weekly.
89238|NCT02031458|B4|Baseline|Total|Total of all reporting groups
89239|NCT02031458|B3|Baseline|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
89240|NCT02031458|B2|Baseline|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
89241|NCT02031458|B1|Baseline|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
89242|NCT02031458|P3|Participant Flow|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
89243|NCT02031458|P2|Participant Flow|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in Eastern Cooperative Oncology Group (ECOG) performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
89244|NCT02031458|P1|Participant Flow|Cohort 1: First Line Atezolizumab|Participants received 1200 milligrams (mg) atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by intravenous (IV) infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
89245|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
89246|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
89260|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
89247|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
89248|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
89249|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
89250|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
89251|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
89252|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
89253|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
89254|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
89255|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
89256|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
89257|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
89258|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
89259|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
89562|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89261|NCT02031458|O1|Outcome|Pharmacokinetic Evaluable Population|Participants received 1200 milligrams (mg) atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by intravenous (IV) infusion until intolerable toxicity, disease progression or death. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
89262|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
89263|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
89264|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
89265|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
89266|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
89267|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
89268|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
89269|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
89270|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
89271|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
89272|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
89273|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
89274|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
89301|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
90189|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
89275|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
89276|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
89277|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
89278|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
89279|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
89280|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
89281|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
89282|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
89283|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
89284|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
89285|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
89286|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
89287|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
89302|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
89288|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
89289|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
89290|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
89291|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
89292|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
89293|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
89294|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
89295|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
89296|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
89297|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
89298|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
89299|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
89300|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
89563|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89303|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
89304|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
89305|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
89306|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
89307|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
89308|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
89309|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
89310|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
89311|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
89312|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
89313|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
89314|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
89315|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
89412|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler."
89316|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
89317|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
89318|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
89319|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
89320|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
89321|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
89322|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
89323|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
89324|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
89325|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
89326|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
89327|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
89328|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
89413|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations ante meridiem (a.m.) dosing."
90190|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
89329|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
89330|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
89331|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
89332|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
89333|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
89334|NCT02031458|E3|Reported Event|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
89335|NCT02031458|E2|Reported Event|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
89336|NCT02031458|E1|Reported Event|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
89337|NCT02030600|B3|Baseline|Total|Total of all reporting groups
89338|NCT02030600|B2|Baseline|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total insulin daily dose was recommended. Doses of IGlar and IDeg were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
89339|NCT02030600|B1|Baseline|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Doses of IDeg and IGlar were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
89340|NCT02030600|P2|Participant Flow|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total insulin daily dose was recommended. Doses of IGlar and IDeg were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
89623|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89341|NCT02030600|P1|Participant Flow|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received insulin degludec (IDeg) in treatment period 1 and insulin glargine (IGlar) in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Doses of IDeg and IGlar were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting self-measured plasma glucose (SMPG) values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
89342|NCT02030600|O2|Outcome|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total insulin daily dose was recommended. Doses of IGlar and IDeg were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
89343|NCT02030600|O1|Outcome|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Doses of IDeg and IGlar were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
89344|NCT02030600|O2|Outcome|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total insulin daily dose was recommended. Doses of IGlar and IDeg were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
89345|NCT02030600|O1|Outcome|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Doses of IDeg and IGlar were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
89346|NCT02030600|O2|Outcome|Insulin Glargine (IGlar)|Subjects receiving IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IGlar was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
89347|NCT02030600|O1|Outcome|Insulin Degludec (IDeg)|Subjects receiving IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
89378|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89379|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89380|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
90191|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
89348|NCT02030600|O2|Outcome|Insulin Glargine (IGlar)|Subjects receiving IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IGlar was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
89349|NCT02030600|O1|Outcome|Insulin Degludec (IDeg)|Subjects receiving IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
89350|NCT02030600|O2|Outcome|Insulin Glargine (IGlar)|Subjects receiving IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IGlar was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
89351|NCT02030600|O1|Outcome|Insulin Degludec (IDeg)|Subjects receiving IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
89352|NCT02030600|O2|Outcome|Insulin Glargine (IGlar)|Subjects receiving IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IGlar was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
89353|NCT02030600|O1|Outcome|Insulin Degludec (IDeg)|Subjects receiving IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
89354|NCT02030600|E2|Reported Event|Insulin Glargine (IGlar)|Subjects receiving IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IGlar was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
89381|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89382|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89383|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
89355|NCT02030600|E1|Reported Event|Insulin Degludec (IDeg)|Subjects receiving IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
89356|NCT02030574|B1|Baseline|Gemcitabine and Fractionated Cisplatin (Combination Treatment)|"1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8~Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.~GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8"
89357|NCT02030574|P1|Participant Flow|Gemcitabine and Fractionated Cisplatin (Combination Treatment)|"1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8~Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.~GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8"
89358|NCT02030574|O1|Outcome|Gemcitabine and Fractionated Cisplatin (Combination Treatment)|"1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8~Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.~GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8"
89359|NCT02030574|O1|Outcome|Gemcitabine and Fractionated Cisplatin (Combination Treatment)|"1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8~Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.~GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8"
89360|NCT02030574|E1|Reported Event|Gemcitabine and Fractionated Cisplatin (Combination Treatment)|"1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8~Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.~GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8"
89361|NCT02030535|B1|Baseline|Overall Study|Total number of patients randomised and treated in the study.
89362|NCT02030535|P1|Participant Flow|Overall Study|Total number of patients randomised and treated in the study. (This is a cross-over trial consisting of a minimum two-week screening period. After screening, eligible patients were randomly assigned to one of 12 treatment sequences. Each patient received all three treatments as single doses on the three test days. Between test days with single dose administration there are 3-week washout periods.)
89363|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89364|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89365|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
89366|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89367|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89368|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
89369|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89370|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89371|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
89372|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89373|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89374|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
89375|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination) Olodaterol: 5 μg (2.5 μg per actuation) Tiotropium: 5 μg (2.5 μg per actuation) 2 inhalations a.m. dosing via RESPIMAT® inhaler
89376|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89377|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
90192|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
89384|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89385|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89386|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
89387|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89388|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89389|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
89390|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89391|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89392|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
89393|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89394|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89395|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
89396|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89397|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89398|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
89399|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89400|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89401|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
89402|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89403|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89404|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
89405|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89406|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89407|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
89408|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89409|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89410|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
89411|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler."
89777|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
89414|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations (a.m. dosing) via RESPIMAT® inhaler"
89415|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations (a.m. dosing) via RESPIMAT® inhaler"
89416|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
89417|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89418|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89419|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
89420|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89421|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89422|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
89423|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89424|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
89425|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
89426|NCT02030535|E3|Reported Event|Tiotropium and Olodaterol FC|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination FC (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing."
89427|NCT02030535|E2|Reported Event|Tio+Olo FDC|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation via RESPIMAT inhaler.~2 inhalations a.m. dosing."
89428|NCT02030535|E1|Reported Event|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
89429|NCT02030405|B1|Baseline|Ixazomib (MLN9708)|Patients receive ixazomib PO on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
89430|NCT02030405|P1|Participant Flow|Ixazomib (MLN9708)|Patients receive ixazomib PO on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
89431|NCT02030405|O1|Outcome|Ixazomib (MLN9708)|Ixazomib was administered PO on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
89432|NCT02030405|O1|Outcome|Ixazomib (MLN9708)|Patients receive ixazomib orally on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
89433|NCT02030405|E1|Reported Event|Ixazomib (MLN9708)|Patients receive ixazomib PO on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
89434|NCT02030119|B5|Baseline|Total|Total of all reporting groups
89435|NCT02030119|B4|Baseline|Loss Framing|"The participants will be told that their account has been credited a certain amount of money for the upcoming 30 days. However, for each day they do not meet their goal of at least 7000 steps, they will lose a small portion of that money. The participant will receive either an email or text message (based on the participant's preference) stating whether the participant achieved the goal for the prior day. Non-adherent participants will receive messages about how much the participant would have kept had they met the target step goal.~Financial Incentives~Daily feedback"
89436|NCT02030119|B3|Baseline|Daily Lottery|"Each participant will be entered into a lottery daily, but participants will only be eligible to collect their winnings if they walked at least 7000 steps the day before. Participants will receive either an email or text message (based on the participant's preference) stating whether or not they won the lottery and if they met their target step goal. If both occur, the participant will be told how much money he or she won. Non-adherent participants will receive messages about how much they would have won had they met the target step goal.~Financial Incentives~Daily feedback"
89437|NCT02030119|B2|Baseline|Gain Framing|"Participants will be told that they will earn money for each day they walk at least 7000 steps. Each participant will receive either an email or text message (based on the participant's preference) stating whether or not he/she achieved the goal for the prior day and can collect the earnings. Non-adherent participants will receive messages about how much they would have earned had they met their target step goal.~Financial Incentives~Daily feedback"
89438|NCT02030119|B1|Baseline|Control|"The participant will receive either an email or text message (based on the participant’s preference) stating whether the participant achieved their goal for the prior day.~Daily feedback"
89491|NCT02030041|E1|Reported Event|Simvastatin and Placebo|"Eleven participants will be vitaminD deficient with LDL-C between 100 to 130mg/dl This arm will receive Simvastatin 40 mg once daily and placebo once weekly, and will exercise for twelve weeks~Simvastatin: Simvastatin in a dose of 40 mg will be provided to the study participants~Placebo: Placebo will be provided to the study participants"
89439|NCT02030119|P4|Participant Flow|Loss Framing|"The participants will be told that their account has been credited a certain amount of money for the upcoming 30 days. However, for each day they do not meet their goal of at least 7000 steps, they will lose a small portion of that money. The participant will receive either an email or text message (based on the participant's preference) stating whether the participant achieved the goal for the prior day. Non-adherent participants will receive messages about how much the participant would have kept had they met the target step goal.~Financial Incentives~Daily feedback"
89440|NCT02030119|P3|Participant Flow|Daily Lottery|"Each participant will be entered into a lottery daily, but participants will only be eligible to collect their winnings if they walked at least 7000 steps the day before. Participants will receive either an email or text message (based on the participant's preference) stating whether or not they won the lottery and if they met their target step goal. If both occur, the participant will be told how much money he or she won. Non-adherent participants will receive messages about how much they would have won had they met the target step goal.~Financial Incentives~Daily feedback"
89441|NCT02030119|P2|Participant Flow|Gain Framing|"Participants will be told that they will earn money for each day they walk at least 7000 steps. Each participant will receive either an email or text message (based on the participant's preference) stating whether or not he/she achieved the goal for the prior day and can collect the earnings. Non-adherent participants will receive messages about how much they would have earned had they met their target step goal.~Financial Incentives~Daily feedback"
89442|NCT02030119|P1|Participant Flow|Control|"The participant will receive either an email or text message (based on the participant’s preference) stating whether the participant achieved their goal for the prior day.~Daily feedback"
89443|NCT02030119|O4|Outcome|Loss Framing|"The participants will be told that their account has been credited a certain amount of money for the upcoming 30 days. However, for each day they do not meet their goal of at least 7000 steps, they will lose a small portion of that money. The participant will receive either an email or text message (based on the participant's preference) stating whether the participant achieved the goal for the prior day. Non-adherent participants will receive messages about how much the participant would have kept had they met the target step goal.~Financial Incentives~Daily feedback"
89444|NCT02030119|O3|Outcome|Daily Lottery|"Each participant will be entered into a lottery daily, but participants will only be eligible to collect their winnings if they walked at least 7000 steps the day before. Participants will receive either an email or text message (based on the participant's preference) stating whether or not they won the lottery and if they met their target step goal. If both occur, the participant will be told how much money he or she won. Non-adherent participants will receive messages about how much they would have won had they met the target step goal.~Financial Incentives~Daily feedback"
89445|NCT02030119|O2|Outcome|Gain Framing|"Participants will be told that they will earn money for each day they walk at least 7000 steps. Each participant will receive either an email or text message (based on the participant's preference) stating whether or not he/she achieved the goal for the prior day and can collect the earnings. Non-adherent participants will receive messages about how much they would have earned had they met their target step goal.~Financial Incentives~Daily feedback"
89446|NCT02030119|O1|Outcome|Control|"The participant will receive either an email or text message (based on the participant’s preference) stating whether the participant achieved their goal for the prior day.~Daily feedback"
89447|NCT02030119|O4|Outcome|Loss Framing|"The participants will be told that their account has been credited a certain amount of money for the upcoming 30 days. However, for each day they do not meet their goal of at least 7000 steps, they will lose a small portion of that money. The participant will receive either an email or text message (based on the participant's preference) stating whether the participant achieved the goal for the prior day. Non-adherent participants will receive messages about how much the participant would have kept had they met the target step goal.~Financial Incentives~Daily feedback"
89448|NCT02030119|O3|Outcome|Daily Lottery|"Each participant will be entered into a lottery daily, but participants will only be eligible to collect their winnings if they walked at least 7000 steps the day before. Participants will receive either an email or text message (based on the participant's preference) stating whether or not they won the lottery and if they met their target step goal. If both occur, the participant will be told how much money he or she won. Non-adherent participants will receive messages about how much they would have won had they met the target step goal.~Financial Incentives~Daily feedback"
89449|NCT02030119|O2|Outcome|Gain Framing|"Participants will be told that they will earn money for each day they walk at least 7000 steps. Each participant will receive either an email or text message (based on the participant's preference) stating whether or not he/she achieved the goal for the prior day and can collect the earnings. Non-adherent participants will receive messages about how much they would have earned had they met their target step goal.~Financial Incentives~Daily feedback"
89450|NCT02030119|O1|Outcome|Control|"The participant will receive either an email or text message (based on the participant’s preference) stating whether the participant achieved their goal for the prior day.~Daily feedback"
89451|NCT02030119|E4|Reported Event|Loss Framing|"The participants will be told that their account has been credited a certain amount of money for the upcoming 30 days. However, for each day they do not meet their goal of at least 7000 steps, they will lose a small portion of that money. The participant will receive either an email or text message (based on the participant's preference) stating whether the participant achieved the goal for the prior day. Non-adherent participants will receive messages about how much the participant would have kept had they met the target step goal.~Financial Incentives~Daily feedback"
89452|NCT02030119|E3|Reported Event|Daily Lottery|"Each participant will be entered into a lottery daily, but participants will only be eligible to collect their winnings if they walked at least 7000 steps the day before. Participants will receive either an email or text message (based on the participant's preference) stating whether or not they won the lottery and if they met their target step goal. If both occur, the participant will be told how much money he or she won. Non-adherent participants will receive messages about how much they would have won had they met the target step goal.~Financial Incentives~Daily feedback"
89492|NCT02029989|B3|Baseline|Total|Total of all reporting groups
89530|NCT02029755|B3|Baseline|PCA Only|"postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
89453|NCT02030119|E2|Reported Event|Gain Framing|"Participants will be told that they will earn money for each day they walk at least 7000 steps. Each participant will receive either an email or text message (based on the participant's preference) stating whether or not he/she achieved the goal for the prior day and can collect the earnings. Non-adherent participants will receive messages about how much they would have earned had they met their target step goal.~Financial Incentives~Daily feedback"
89454|NCT02030119|E1|Reported Event|Control|"The participant will receive either an email or text message (based on the participant’s preference) stating whether the participant achieved their goal for the prior day.~Daily feedback"
89455|NCT02030080|B5|Baseline|Total|Total of all reporting groups
89456|NCT02030080|B4|Baseline|Feedback 75th Percentile + Lottery|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 75th percentile in their arm. If their team's average daily step count is ≥ 7000 steps, they'll be eligible to collect winnings from a weekly lottery. Teams whose average daily step count is less than 7000 will receive messages about how much they would have won had the team met its goal.~Financial incentives~Teams~Framing of feedback~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
89457|NCT02030080|B3|Baseline|Feedback 50th Percentile + Lottery|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 50th percentile in their arm. If their team's average daily step count is ≥ 7000 steps, they'll be eligible to collect winnings from a weekly lottery. Teams whose average daily step count is less than 7000 will receive messages about how much they would have won had the team met its goal.~Financial incentives~Teams~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
89458|NCT02030080|B2|Baseline|Feedback 75th Percentile|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 75th percentile in their arm.~Teams~Framing of feedback~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
89459|NCT02030080|B1|Baseline|Feedback 50th Percentile|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 50th percentile in their arm.~Teams~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
89460|NCT02030080|P4|Participant Flow|Feedback 75th Percentile + Lottery|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 75th percentile in their arm. If their team's average daily step count is ≥ 7000 steps, they'll be eligible to collect winnings from a weekly lottery. Teams whose average daily step count is less than 7000 will receive messages about how much they would have won had the team met its goal.~Financial incentives~Teams~Framing of feedback~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
89461|NCT02030080|P3|Participant Flow|Feedback 50th Percentile + Lottery|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 50th percentile in their arm. If their team's average daily step count is ≥ 7000 steps, they'll be eligible to collect winnings from a weekly lottery. Teams whose average daily step count is less than 7000 will receive messages about how much they would have won had the team met its goal.~Financial incentives~Teams~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
89462|NCT02030080|P2|Participant Flow|Feedback 75th Percentile|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 75th percentile in their arm.~Teams~Framing of feedback~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
89463|NCT02030080|P1|Participant Flow|Feedback 50th Percentile|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 50th percentile in their arm.~Teams~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
89464|NCT02030080|O4|Outcome|Feedback 75th Percentile + Lottery|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 75th percentile in their arm. If their team's average daily step count is ≥ 7000 steps, they'll be eligible to collect winnings from a weekly lottery. Teams whose average daily step count is less than 7000 will receive messages about how much they would have won had the team met its goal.~Financial incentives~Teams~Framing of feedback~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
89465|NCT02030080|O3|Outcome|Feedback 50th Percentile + Lottery|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 50th percentile in their arm. If their team's average daily step count is ≥ 7000 steps, they'll be eligible to collect winnings from a weekly lottery. Teams whose average daily step count is less than 7000 will receive messages about how much they would have won had the team met its goal.~Financial incentives~Teams~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
89466|NCT02030080|O2|Outcome|Feedback 75th Percentile|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 75th percentile in their arm.~Teams~Framing of feedback~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
89467|NCT02030080|O1|Outcome|Feedback 50th Percentile|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 50th percentile in their arm.~Teams~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
89506|NCT02029911|E1|Reported Event|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
89507|NCT02029872|B3|Baseline|Total|Total of all reporting groups
90193|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
89468|NCT02030080|O4|Outcome|Feedback 75th Percentile + Lottery|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 75th percentile in their arm. If their team's average daily step count is ≥ 7000 steps, they'll be eligible to collect winnings from a weekly lottery. Teams whose average daily step count is less than 7000 will receive messages about how much they would have won had the team met its goal.~Financial incentives~Teams~Framing of feedback~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
89469|NCT02030080|O3|Outcome|Feedback 50th Percentile + Lottery|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 50th percentile in their arm. If their team's average daily step count is ≥ 7000 steps, they'll be eligible to collect winnings from a weekly lottery. Teams whose average daily step count is less than 7000 will receive messages about how much they would have won had the team met its goal.~Financial incentives~Teams~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
89470|NCT02030080|O2|Outcome|Feedback 75th Percentile|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 75th percentile in their arm.~Teams~Framing of feedback~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
89471|NCT02030080|O1|Outcome|Feedback 50th Percentile|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 50th percentile in their arm.~Teams~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
89472|NCT02030080|E4|Reported Event|Feedback 75th Percentile + Lottery|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 75th percentile in their arm. If their team's average daily step count is ≥ 7000 steps, they'll be eligible to collect winnings from a weekly lottery. Teams whose average daily step count is less than 7000 will receive messages about how much they would have won had the team met its goal.~Financial incentives~Teams~Framing of feedback~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
89473|NCT02030080|E3|Reported Event|Feedback 50th Percentile + Lottery|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 50th percentile in their arm. If their team's average daily step count is ≥ 7000 steps, they'll be eligible to collect winnings from a weekly lottery. Teams whose average daily step count is less than 7000 will receive messages about how much they would have won had the team met its goal.~Financial incentives~Teams~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
89474|NCT02030080|E2|Reported Event|Feedback 75th Percentile|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 75th percentile in their arm.~Teams~Framing of feedback~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
89475|NCT02030080|E1|Reported Event|Feedback 50th Percentile|"At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 50th percentile in their arm.~Teams~Daily Feedback: Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before."
89476|NCT02030041|B4|Baseline|Total|Total of all reporting groups
89477|NCT02030041|B3|Baseline|Vitamin D and Placebo|Participants took vitamin D 60000 units once weekly and performed exercise for 12 weeks
89478|NCT02030041|B2|Baseline|Simvastatin and Vitamin D|Participants took simvastatin 40 mg once daily and vitamin D 60,000 units once weekly, and performed exercise for 12 weeks
89479|NCT02030041|B1|Baseline|Simvastatin and Placebo|Participants took simvastatin 40 mg once daily and performed exercise for 12 weeks
89480|NCT02030041|P3|Participant Flow|Vitamin D and Placebo|Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive vitamin D 60,000 units once weekly and placebo once daily, and will exercise for twelve weeks
89481|NCT02030041|P2|Participant Flow|Simvastatin and Vitamin D|Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive Simvastatin 40 mg once daily and vitamin D 60000 units once weekly, and will exercise for twelve weeks
89482|NCT02030041|P1|Participant Flow|Simvastatin and Placebo|Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive simvastatin 40 mg once daily and placebo once weekly , and will exercise for twelve weeks
89483|NCT02030041|O3|Outcome|Vitamin D and Placebo|Participants received vitamin D 60,000 units once weekly and performed exercise for 12 weeks
89484|NCT02030041|O2|Outcome|Simvastatin and Vitamin D|Participants received simvastatin 40 mg once daily and vitamin D 60,000 units once weekly, and performed exercise for 12 weeks
89485|NCT02030041|O1|Outcome|Simvastatin and Placebo|Participants received simvastatin 40 mg once daily and performed exercise for 12 weeks
89486|NCT02030041|O3|Outcome|Vitamin D and Placebo|Participants received vitamin D 60,000 units once weekly and performed exercise for 12 weeks
89487|NCT02030041|O2|Outcome|Simvastatin and Vitamin D|Participants received simvastatin 40 mg once daily and vitamin D 60,000 units once weekly, and performed exercise for 12 weeks
89488|NCT02030041|O1|Outcome|Simvastatin and Placebo|Participants received simvastatin 40 mg once daily and performed exercise for 12 weeks
89489|NCT02030041|E3|Reported Event|Vitamin D and Placebo|"Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive vitamin D 60,000 units once weekly and placebo once daily, and will exercise for twelve weeks~Vitamin D: Vitamin D will be given to achieve normal serum levels~Placebo: Placebo will be provided to the study participants"
89490|NCT02030041|E2|Reported Event|Simvastatin and Vitamin D|"Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive simvastatin 40 mg once daily and vitamin D 60,000 units once weekly , and will exercise for twelve weeks~Vitamin D: Vitamin D will be given to achieve normal serum levels~Simvastatin: Simvastatin in a dose of 40 mg will be provided to the study participants"
89493|NCT02029989|B2|Baseline|No Comprehensive Medication Management Services (NCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference"
89494|NCT02029989|B1|Baseline|Pharmacist Comprehensive Medication Management Service (PCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference~Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management"
89495|NCT02029989|P2|Participant Flow|No Comprehensive Medication Management Services (NCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference"
89496|NCT02029989|P1|Participant Flow|Pharmacist Comprehensive Medication Management Service (PCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference~Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management"
89497|NCT02029989|O2|Outcome|No Comprehensive Medication Management Services (NCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference"
89498|NCT02029989|O1|Outcome|Pharmacist Comprehensive Medication Management Service (PCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference~Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management"
89499|NCT02029989|E2|Reported Event|No Comprehensive Medication Management Services (NCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference"
89500|NCT02029989|E1|Reported Event|Pharmacist Comprehensive Medication Management Service (PCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference~Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management"
89501|NCT02029911|B1|Baseline|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
89502|NCT02029911|P1|Participant Flow|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
89503|NCT02029911|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
89504|NCT02029911|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
89505|NCT02029911|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
90194|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
89508|NCT02029872|B2|Baseline|Individual Plus Household|"Standard decolonization regimen for individual plus household: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days.~Chlorhexidine gluconate soap: 4% chlorhexidine gluconate (soap)~Chlorhexidine gluconate oral rinse: chlorhexidine gluconate oral rinse 0.12%~Mupirocin calcium 2 % ointment: nasal mupirocin calcium 2% ointment"
89509|NCT02029872|B1|Baseline|Individual Alone|"Standard decolonization regimen for the individual alone: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily, plus a 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days.~Chlorhexidine gluconate soap: 4% chlorhexidine gluconate (soap)~Chlorhexidine gluconate oral rinse: chlorhexidine gluconate oral rinse 0.12%~Mupirocin calcium 2 % ointment: nasal mupirocin calcium 2% ointment"
89510|NCT02029872|P2|Participant Flow|Individual Plus Household|"Standard decolonization regimen for individual plus household: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days.~Chlorhexidine gluconate soap: 4% chlorhexidine gluconate (soap)~Chlorhexidine gluconate oral rinse: chlorhexidine gluconate oral rinse 0.12%~Mupirocin calcium 2 % ointment: nasal mupirocin calcium 2% ointment"
89511|NCT02029872|P1|Participant Flow|Individual Alone|"Standard decolonization regimen for the individual alone: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily, plus a 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days.~Chlorhexidine gluconate soap: 4% chlorhexidine gluconate (soap)~Chlorhexidine gluconate oral rinse: chlorhexidine gluconate oral rinse 0.12%~Mupirocin calcium 2 % ointment: nasal mupirocin calcium 2% ointment"
89512|NCT02029872|O2|Outcome|Individual Plus Household|"Standard decolonization regimen for individual plus household: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days.~Chlorhexidine gluconate soap: 4% chlorhexidine gluconate (soap)~Chlorhexidine gluconate oral rinse: chlorhexidine gluconate oral rinse 0.12%~Mupirocin calcium 2 % ointment: nasal mupirocin calcium 2% ointment"
89513|NCT02029872|O1|Outcome|Individual Alone|"Standard decolonization regimen for the individual alone: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily, plus a 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days.~Chlorhexidine gluconate soap: 4% chlorhexidine gluconate (soap)~Chlorhexidine gluconate oral rinse: chlorhexidine gluconate oral rinse 0.12%~Mupirocin calcium 2 % ointment: nasal mupirocin calcium 2% ointment"
89514|NCT02029872|E2|Reported Event|Individual Plus Household|"Standard decolonization regimen for individual plus household: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days.~Chlorhexidine gluconate soap: 4% chlorhexidine gluconate (soap)~Chlorhexidine gluconate oral rinse: chlorhexidine gluconate oral rinse 0.12%~Mupirocin calcium 2 % ointment: nasal mupirocin calcium 2% ointment"
89515|NCT02029872|E1|Reported Event|Individual Alone|"Standard decolonization regimen for the individual alone: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily, plus a 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days.~Chlorhexidine gluconate soap: 4% chlorhexidine gluconate (soap)~Chlorhexidine gluconate oral rinse: chlorhexidine gluconate oral rinse 0.12%~Mupirocin calcium 2 % ointment: nasal mupirocin calcium 2% ointment"
89516|NCT02029846|B3|Baseline|Total|Total of all reporting groups
89517|NCT02029846|B2|Baseline|Incretin-based Treatment|"A regimen including incretin-based drugs~Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs"
89518|NCT02029846|B1|Baseline|Standard Treatment|"A regimen with traditional drugs only~Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only"
89519|NCT02029846|P2|Participant Flow|Incretin-based Treatment|"A regimen including incretin-based drugs~Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs"
89520|NCT02029846|P1|Participant Flow|Standard Treatment|"A regimen with traditional drugs only~Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only"
89521|NCT02029846|O2|Outcome|Incretin-based Treatment|"A regimen including incretin-based drugs~Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs"
89522|NCT02029846|O1|Outcome|Standard Treatment|"A regimen with traditional drugs only~Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only"
89523|NCT02029846|O2|Outcome|Incretin-based Treatment|"A regimen including incretin-based drugs~Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs"
89524|NCT02029846|O1|Outcome|Standard Treatment|"A regimen with traditional drugs only~Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only"
89525|NCT02029846|O2|Outcome|Incretin-based Treatment|"A regimen including incretin-based drugs~Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs"
89526|NCT02029846|O1|Outcome|Standard Treatment|"A regimen with traditional drugs only~Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only"
89527|NCT02029846|E2|Reported Event|Incretin-based Treatment|"A regimen including incretin-based drugs~Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs"
89528|NCT02029846|E1|Reported Event|Standard Treatment|"A regimen with traditional drugs only~Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only"
89529|NCT02029755|B4|Baseline|Total|Total of all reporting groups
89531|NCT02029755|B2|Baseline|Local Infiltration|"postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
89532|NCT02029755|B1|Baseline|TAP Block|"postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
89533|NCT02029755|P3|Participant Flow|PCA Only|"postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
89534|NCT02029755|P2|Participant Flow|Local Infiltration|"postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
89535|NCT02029755|P1|Participant Flow|TAP Block|"postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
89536|NCT02029755|O3|Outcome|PCA Only|"postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
89537|NCT02029755|O2|Outcome|Local Infiltration|"postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
89538|NCT02029755|O1|Outcome|TAP Block|"postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
89539|NCT02029755|O3|Outcome|PCA Only|"postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
89540|NCT02029755|O2|Outcome|Local Infiltration|"postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
89541|NCT02029755|O1|Outcome|TAP Block|"postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
89542|NCT02029755|E3|Reported Event|PCA Only|"postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
89543|NCT02029755|E2|Reported Event|Local Infiltration|"postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
89860|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89544|NCT02029755|E1|Reported Event|TAP Block|"postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
89545|NCT02029703|B3|Baseline|Total|Total of all reporting groups
89546|NCT02029703|B2|Baseline|Synvisc-One Injection|"Subjects randomized into the Synvisc-One group will receive a single 6 mL intra-articular injection of Synvisc-One under sterile conditions. The unblinded treating physician will prepare the treatment site according to his/her standard practice guidelines (i.e. after cutaneous numbing with a vasocoolant spray and / or local lidocaine injection), an 18 gauge needle will be advanced into one of three compartments of the knee using the injectors' technique of choice. Subjects will be monitored for a minimum 5 minutes post injection to evaluate for adverse events.~Synvisc-One Injection"
89547|NCT02029703|B1|Baseline|Sham Injection|"Subjects randomized into this group will receive, under sterile conditions, a sham injection of lidocaine 1% (10 mg/ml) 1-2 ml. Sterile preparation of the affected knee (treatment site) and the sham injection procedure will take place after sterile preparation into subcutaneous tissue without involving treatment to the intra-articular joint. The sham procedure will be performed by the unblinded treating physician ONLY. This procedure will include an 22-25 gauge needle stick through the skin into the subcutaneous tissue without violating the joint capsule or performing arthrocentesis.~Sham Injection"
89548|NCT02029703|P2|Participant Flow|Synvisc-One Injection|"Subjects randomized into the Synvisc-One group will receive a single 6 mL intra-articular injection of Synvisc-One under sterile conditions. The unblinded treating physician will prepare the treatment site according to his/her standard practice guidelines (i.e. after cutaneous numbing with a vasocoolant spray and / or local lidocaine injection), an 18 gauge needle will be advanced into one of three compartments of the knee using the injectors' technique of choice. Subjects will be monitored for a minimum 5 minutes post injection to evaluate for adverse events.~Synvisc-One Injection"
89549|NCT02029703|P1|Participant Flow|Sham Injection|"Subjects randomized into this group will receive, under sterile conditions, a sham injection of lidocaine 1% (10 mg/ml) 1-2 ml. Sterile preparation of the affected knee (treatment site) and the sham injection procedure will take place after sterile preparation into subcutaneous tissue without involving treatment to the intra-articular joint. The sham procedure will be performed by the unblinded treating physician ONLY. This procedure will include an 22-25 gauge needle stick through the skin into the subcutaneous tissue without violating the joint capsule or performing arthrocentesis.~Sham Injection"
89550|NCT02029703|O2|Outcome|Synvisc-One Injection|"Subjects randomized into the Synvisc-One group will receive a single 6 mL intra-articular injection of Synvisc-One under sterile conditions. The unblinded treating physician will prepare the treatment site according to his/her standard practice guidelines (i.e. after cutaneous numbing with a vasocoolant spray and / or local lidocaine injection), an 18 gauge needle will be advanced into one of three compartments of the knee using the injectors' technique of choice. Subjects will be monitored for a minimum 5 minutes post injection to evaluate for adverse events.~Synvisc-One Injection"
89551|NCT02029703|O1|Outcome|Sham Injection|Subjects randomized into this group will receive, under sterile conditions, a sham injection of lidocaine 1% (10 mg/ml) 1-2 ml. Sterile preparation of the affected knee (treatment site) and the sham injection procedure will take place after sterile preparation into subcutaneous tissue without involving treatment to the intra-articular joint. The sham procedure will be performed by the unblinded treating physician ONLY. This procedure will include an 22-25 gauge needle stick through the skin into the subcutaneous tissue without violating the joint capsule or performing arthrocentesis.
89552|NCT02029703|E2|Reported Event|Synvisc-One Injection|"Subjects randomized into the Synvisc-One group will receive a single 6 mL intra-articular injection of Synvisc-One under sterile conditions. The unblinded treating physician will prepare the treatment site according to his/her standard practice guidelines (i.e. after cutaneous numbing with a vasocoolant spray and / or local lidocaine injection), an 18 gauge needle will be advanced into one of three compartments of the knee using the injectors' technique of choice. Subjects will be monitored for a minimum 5 minutes post injection to evaluate for adverse events.~Synvisc-One Injection"
89553|NCT02029703|E1|Reported Event|Sham Injection|"Subjects randomized into this group will receive, under sterile conditions, a sham injection of lidocaine 1% (10 mg/ml) 1-2 ml. Sterile preparation of the affected knee (treatment site) and the sham injection procedure will take place after sterile preparation into subcutaneous tissue without involving treatment to the intra-articular joint. The sham procedure will be performed by the unblinded treating physician ONLY. This procedure will include an 22-25 gauge needle stick through the skin into the subcutaneous tissue without violating the joint capsule or performing arthrocentesis.~Sham Injection"
89554|NCT02029521|B3|Baseline|Total|Total of all reporting groups
89555|NCT02029521|B2|Baseline|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89556|NCT02029521|B1|Baseline|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89557|NCT02029521|P2|Participant Flow|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89558|NCT02029521|P1|Participant Flow|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
89559|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89560|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89564|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89565|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89566|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89567|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89568|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89569|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89570|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89571|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89572|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89573|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89574|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89575|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89576|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89577|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89578|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89579|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89580|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89581|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89582|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89583|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89584|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89585|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89586|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89587|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89588|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89589|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89590|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89591|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89592|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89593|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89594|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89595|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89596|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89597|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89598|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89599|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89600|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89601|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89602|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89603|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89604|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89605|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89606|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
89607|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89608|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
89609|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89610|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
89611|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89612|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
89613|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89614|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
89615|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89616|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
89617|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89618|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
89619|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89620|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
89621|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89622|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
89624|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
89625|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89626|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89627|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89628|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
89629|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89630|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
89631|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89632|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
89633|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89634|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
89635|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89636|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
89637|NCT02029521|E2|Reported Event|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
89638|NCT02029521|E1|Reported Event|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
89639|NCT02029495|B4|Baseline|Total|Total of all reporting groups
89640|NCT02029495|B3|Baseline|Placebo|"Administered via subcutaneous injection until week 24.~Placebo: Placebo administered via subcutaneous injection until week 24."
89641|NCT02029495|B2|Baseline|140 mg Brodalumab|"Administered via subcutaneous injection~140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection"
89642|NCT02029495|B1|Baseline|210 mg Brodalumab|"Administered via subcutaneous injections~210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection"
89643|NCT02029495|P3|Participant Flow|Placebo|"Administered via subcutaneous injection until week 24.~Placebo: Placebo administered via subcutaneous injection until week 24."
89644|NCT02029495|P2|Participant Flow|140 mg Brodalumab|"Administered via subcutaneous injection~140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection"
89645|NCT02029495|P1|Participant Flow|210 mg Brodalumab|"Administered via subcutaneous injections~210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection"
89646|NCT02029495|O3|Outcome|Placebo|"Administered via subcutaneous injection until week 24.~Placebo: Placebo administered via subcutaneous injection until week 24."
89647|NCT02029495|O2|Outcome|140 mg Brodalumab|"Administered via subcutaneous injection~140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection"
89648|NCT02029495|O1|Outcome|210 mg Brodalumab|"Administered via subcutaneous injections~210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection"
89649|NCT02029495|O3|Outcome|Placebo|"Administered via subcutaneous injection until week 24.~Placebo: Placebo administered via subcutaneous injection until week 24."
89650|NCT02029495|O2|Outcome|140 mg Brodalumab|"Administered via subcutaneous injection~140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection"
89651|NCT02029495|O1|Outcome|210 mg Brodalumab|"Administered via subcutaneous injections~210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection"
89652|NCT02029495|E3|Reported Event|Placebo|"Administered via subcutaneous injection until week 24.~Placebo: Placebo administered via subcutaneous injection until week 24."
89653|NCT02029495|E2|Reported Event|140 mg Brodalumab|"Administered via subcutaneous injection~140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection"
89654|NCT02029495|E1|Reported Event|210 mg Brodalumab|"Administered via subcutaneous injections~210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection"
89655|NCT02029417|B1|Baseline|Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)|"INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~cytarabine: Given SC~omacetaxine mepesuccinate: Given SC~decitabine: Given IV~laboratory biomarker analysis: Correlative studies"
89656|NCT02029417|P1|Participant Flow|Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)|"INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~cytarabine: Given SC~omacetaxine mepesuccinate: Given SC~decitabine: Given IV~laboratory biomarker analysis: Correlative studies"
89657|NCT02029417|O1|Outcome|Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)|"INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~cytarabine: Given SC~omacetaxine mepesuccinate: Given SC~decitabine: Given IV~laboratory biomarker analysis: Correlative studies"
89658|NCT02029417|O1|Outcome|Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)|"INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~cytarabine: Given SC~omacetaxine mepesuccinate: Given SC~decitabine: Given IV~laboratory biomarker analysis: Correlative studies"
89659|NCT02029417|E1|Reported Event|Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)|"INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~cytarabine: Given SC~omacetaxine mepesuccinate: Given SC~decitabine: Given IV~laboratory biomarker analysis: Correlative studies"
89660|NCT02029196|B3|Baseline|Total|Total of all reporting groups
89661|NCT02029196|B2|Baseline|Conventional Cigarette (CC)|Subjects who continue smoking their usual conventional cigarette (CC) brand.
89662|NCT02029196|B1|Baseline|E-vapour Product (EVP)|Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
89663|NCT02029196|P2|Participant Flow|Conventional Cigarette (CC)|Subjects who continue smoking their usual conventional cigarette (CC) brand.
89664|NCT02029196|P1|Participant Flow|E-vapour Product (EVP)|Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
89665|NCT02029196|O2|Outcome|Conventional Cigarette (CC)|Subjects who continue smoking their usual conventional cigarette (CC) brand.
89666|NCT02029196|O1|Outcome|E-vapour Product (EVP)|Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
89667|NCT02029196|O2|Outcome|Conventional Cigarette (CC)|Subjects who continue smoking their usual conventional cigarette (CC) brand.
89668|NCT02029196|O1|Outcome|E-vapour Product (EVP)|Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
89669|NCT02029196|E2|Reported Event|Conventional Cigarette (CC)|Subjects who continue smoking their usual conventional cigarette (CC) brand.
89670|NCT02029196|E1|Reported Event|E-vapour Product (EVP)|Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
89671|NCT02028780|B13|Baseline|Total|Total of all reporting groups
89672|NCT02028780|B12|Baseline|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89673|NCT02028780|B11|Baseline|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89674|NCT02028780|B10|Baseline|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89675|NCT02028780|B9|Baseline|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89676|NCT02028780|B8|Baseline|DE+Placebo+Placebo (Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d. from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of two doses of matching placebo to Idarucizumab for 5 min + 5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89677|NCT02028780|B7|Baseline|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
89678|NCT02028780|B6|Baseline|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
89679|NCT02028780|B5|Baseline|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
89680|NCT02028780|B4|Baseline|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
89681|NCT02028780|B3|Baseline|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
89682|NCT02028780|B2|Baseline|Placebo_1h (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 1h (hour) on Day 1.
89683|NCT02028780|B1|Baseline|Placebo_5m (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 5min on Day 1.
89684|NCT02028780|P12|Participant Flow|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89685|NCT02028780|P11|Participant Flow|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89686|NCT02028780|P10|Participant Flow|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89687|NCT02028780|P9|Participant Flow|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89688|NCT02028780|P8|Participant Flow|DE+Placebo+Placebo (Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d. from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of two doses of matching placebo to Idarucizumab for 5 min + 5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89689|NCT02028780|P7|Participant Flow|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
89690|NCT02028780|P6|Participant Flow|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
89691|NCT02028780|P5|Participant Flow|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
89692|NCT02028780|P4|Participant Flow|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
89693|NCT02028780|P3|Participant Flow|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
89694|NCT02028780|P2|Participant Flow|Placebo_1h (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 1h (hour) on Day 1.
89695|NCT02028780|P1|Participant Flow|Placebo_5m (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 5min on Day 1.
89696|NCT02028780|O5|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89697|NCT02028780|O4|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89698|NCT02028780|O3|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89699|NCT02028780|O2|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89700|NCT02028780|O1|Outcome|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
89701|NCT02028780|O1|Outcome|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
89702|NCT02028780|O7|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89703|NCT02028780|O6|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89704|NCT02028780|O5|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89705|NCT02028780|O4|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89706|NCT02028780|O3|Outcome|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
89707|NCT02028780|O2|Outcome|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
89708|NCT02028780|O1|Outcome|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
89709|NCT02028780|O8|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89710|NCT02028780|O7|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89711|NCT02028780|O6|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89712|NCT02028780|O5|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89713|NCT02028780|O4|Outcome|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
89714|NCT02028780|O3|Outcome|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
89715|NCT02028780|O2|Outcome|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
89716|NCT02028780|O1|Outcome|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
89717|NCT02028780|O8|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89718|NCT02028780|O7|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89719|NCT02028780|O6|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89720|NCT02028780|O5|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89721|NCT02028780|O4|Outcome|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
89722|NCT02028780|O3|Outcome|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
89723|NCT02028780|O2|Outcome|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
89724|NCT02028780|O1|Outcome|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
89725|NCT02028780|O5|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89726|NCT02028780|O4|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89861|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89727|NCT02028780|O3|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89728|NCT02028780|O2|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89729|NCT02028780|O1|Outcome|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
89730|NCT02028780|O5|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89731|NCT02028780|O4|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89732|NCT02028780|O3|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89733|NCT02028780|O2|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89734|NCT02028780|O1|Outcome|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
89735|NCT02028780|O12|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89736|NCT02028780|O11|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89737|NCT02028780|O10|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89738|NCT02028780|O9|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89739|NCT02028780|O8|Outcome|DE+Placebo+Placebo (Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d. from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of two doses of matching placebo to Idarucizumab for 5 min + 5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89740|NCT02028780|O7|Outcome|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
89741|NCT02028780|O6|Outcome|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
89742|NCT02028780|O5|Outcome|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
89743|NCT02028780|O4|Outcome|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
89744|NCT02028780|O3|Outcome|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
89745|NCT02028780|O2|Outcome|Placebo_1h (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 1h (hour) on Day 1.
89746|NCT02028780|O1|Outcome|Placebo_5m (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 5min on Day 1.
89747|NCT02028780|E12|Reported Event|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89748|NCT02028780|E11|Reported Event|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89862|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89749|NCT02028780|E10|Reported Event|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89750|NCT02028780|E9|Reported Event|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89751|NCT02028780|E8|Reported Event|DE+Placebo+Placebo (Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d. from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of two doses of matching placebo to Idarucizumab for 5 min + 5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
89752|NCT02028780|E7|Reported Event|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
89753|NCT02028780|E6|Reported Event|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
89754|NCT02028780|E5|Reported Event|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
89755|NCT02028780|E4|Reported Event|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
89756|NCT02028780|E3|Reported Event|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
89757|NCT02028780|E2|Reported Event|Placebo_1h (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 1h (hour) on Day 1.
89758|NCT02028780|E1|Reported Event|Placebo_5m (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 5min on Day 1.
89759|NCT02028767|B1|Baseline|Fixed Dose Combination vs. Separate Tablets|12.5 mg Empagliflozin / 500mg metformin fixed dose combination vs. free combination of 2.5 mg tablet Empagliflozin, 10 mg tablet Empagliflozin and 500 mg tablet Metformin
89760|NCT02028767|P2|Participant Flow|Separate Tablets First, Then Fixed Dose Combination (FDC)|"free combination of Empagliflozin 2.5 mg tablet, Empagliflozin 10 mg tablet and Metformin 500 mg tablet first,~then Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin~Both medications were administered oral with 240 mL water after intake of a high-fat, high-calorie meal."
89761|NCT02028767|P1|Participant Flow|Fixed Dose Combination (FDC) First, Then Separate Tablets|"Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin first,~then free combination of Empagliflozin 2.5 mg tablet, Empagliflozin 10 mg tablet and Metformin 500 mg tablet~Both medications were administered oral with 240 mL water after intake of a high-fat, high-calorie meal."
89762|NCT02028767|O2|Outcome|Separate Tablets|"Empagliflozin and Metformin tablets~Empagliflozin 2.5 mg: Empagliflozin 2.5 mg tablet~Empagliflozin 10 mg: Empagliflozin 10 mg tablet~Metformin 500 mg: Metformin 500 mg tablet"
89763|NCT02028767|O1|Outcome|Fixed Dose Combination (FDC)|"12.5 mg Empagliflozin / 500mg metformin fixed dose combination~Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin"
89764|NCT02028767|O2|Outcome|Separate Tablets|"Empagliflozin and Metformin tablets~Empagliflozin 2.5 mg: Empagliflozin 2.5 mg tablet~Empagliflozin 10 mg: Empagliflozin 10 mg tablet~Metformin 500 mg: Metformin 500 mg tablet"
89765|NCT02028767|O1|Outcome|Fixed Dose Combination (FDC)|"12.5 mg Empagliflozin / 500mg metformin fixed dose combination~Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin"
89766|NCT02028767|O2|Outcome|Separate Tablets|"Empagliflozin and Metformin tablets~Empagliflozin 2.5 mg: Empagliflozin 2.5 mg tablet~Empagliflozin 10 mg: Empagliflozin 10 mg tablet~Metformin 500 mg: Metformin 500 mg tablet"
89767|NCT02028767|O1|Outcome|Fixed Dose Combination (FDC)|"12.5 mg Empagliflozin / 500mg metformin fixed dose combination~Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin"
89768|NCT02028767|E2|Reported Event|Separate Tablets|"Empagliflozin and Metformin tablets~Empagliflozin 2.5 mg: Empagliflozin 2.5 mg tablet~Empagliflozin 10 mg: Empagliflozin 10 mg tablet~Metformin 500 mg: Metformin 500 mg tablet"
89769|NCT02028767|E1|Reported Event|Fixed Dose Combination (FDC)|"12.5 mg Empagliflozin / 500mg metformin fixed dose combination~Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin"
89770|NCT02028754|B3|Baseline|Total|Total of all reporting groups
89771|NCT02028754|B2|Baseline|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
89772|NCT02028754|B1|Baseline|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
89773|NCT02028754|P2|Participant Flow|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
89774|NCT02028754|P1|Participant Flow|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
89775|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
89776|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
89863|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89778|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
89779|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
89780|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
89781|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
89782|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
89783|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
89784|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
89785|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
89786|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
89787|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
89788|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
89789|NCT02028754|E2|Reported Event|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
89790|NCT02028754|E1|Reported Event|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
89791|NCT02028676|B10|Baseline|Total|Total of all reporting groups
89792|NCT02028676|B9|Baseline|Stopped Cotrimoxazole Prophylaxis|"Children had been taking once-daily cotrimoxazole prophylaxis since at least ART initiation. Children randomised to this experimental arm stopped taking cotrimoxazole prophylaxis.~Stopped cotrimoxazole prophylaxis"
89793|NCT02028676|B8|Baseline|Continued Cotrimoxazole Prophylaxis|"Once-daily doses 5-<15 kg: 200 mg of trimethoprim + 40 mg sulfamethoxazole 15-<30 kg: 400 mg trimethoprim + 80 mg sulfamethoxazole >=30 kg: 800 mg trimethoprim + 160 mg sulfamethoxazole~Continued cotrimoxazole prophylaxis"
89794|NCT02028676|B7|Baseline|Twice-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO~Twice-daily ABC+3TC"
89795|NCT02028676|B6|Baseline|Once-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed once-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed once-daily according to weight-bands following WHO~Once-daily ABC+3TC"
89796|NCT02028676|B5|Baseline|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89797|NCT02028676|B4|Baseline|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89864|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89865|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89866|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89798|NCT02028676|B3|Baseline|Arm A: Abacavir (ABC)+Lamivudine (3TC)+NNRTI|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO non-nucleoside reverse transcriptase inhibitor (NNRTI): either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm A: ABC+3TC+NNRTI: Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89799|NCT02028676|B2|Baseline|Laboratory Plus Clinical Monitoring (LCM)|Laboratory plus Clinical Monitoring (LCM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89800|NCT02028676|B1|Baseline|Clinically Driven Monitoring (CDM)|Clinically Driven Monitoring (CDM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89801|NCT02028676|P9|Participant Flow|Stopped Cotrimoxazole Prophylaxis|"Children had been taking once-daily cotrimoxazole prophylaxis since at least ART initiation. Children randomised to this experimental arm stopped taking cotrimoxazole prophylaxis.~Stopped cotrimoxazole prophylaxis"
89802|NCT02028676|P8|Participant Flow|Continued Cotrimoxazole Prophylaxis|"Once-daily doses 5-<15 kg: 200 mg of trimethoprim + 40 mg sulfamethoxazole 15-<30 kg: 400 mg trimethoprim + 80 mg sulfamethoxazole >=30 kg: 800 mg trimethoprim + 160 mg sulfamethoxazole~Continued cotrimoxazole prophylaxis"
89803|NCT02028676|P7|Participant Flow|Twice-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO~Twice-daily ABC+3TC"
89804|NCT02028676|P6|Participant Flow|Once-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed once-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed once-daily according to weight-bands following WHO~Once-daily ABC+3TC"
89805|NCT02028676|P5|Participant Flow|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89806|NCT02028676|P4|Participant Flow|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89807|NCT02028676|P3|Participant Flow|Arm A: Abacavir (ABC)+Lamivudine (3TC)+NNRTI|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO non-nucleoside reverse transcriptase inhibitor (NNRTI): either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm A: ABC+3TC+NNRTI: Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89808|NCT02028676|P2|Participant Flow|Laboratory Plus Clinical Monitoring (LCM)|Laboratory plus Clinical Monitoring (LCM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89867|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89868|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89869|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89809|NCT02028676|P1|Participant Flow|Clinically Driven Monitoring (CDM)|Clinically Driven Monitoring (CDM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89810|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
89811|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
89812|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
89813|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
89814|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
89815|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
89816|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
89817|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
89818|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
89819|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
89820|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
89821|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
89822|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
89823|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
89824|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
89825|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
89826|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
89827|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
89828|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
89829|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
89830|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
89831|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
89832|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
89833|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
89834|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
89835|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
89836|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89837|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89838|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89839|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89840|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89841|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89842|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89843|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89844|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89845|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89846|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89847|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89848|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89849|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89850|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89851|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89852|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89853|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89854|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89855|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89856|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89857|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89858|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89859|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89872|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89873|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89874|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89875|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89876|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89877|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89878|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89879|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89880|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89881|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89882|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
90195|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
89883|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89884|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89885|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89886|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89887|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89888|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89889|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89890|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89891|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89892|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89959|NCT02028676|O3|Outcome|ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age"
90058|NCT02027844|E1|Reported Event|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
89893|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89894|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89895|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89896|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89897|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89898|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89899|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89900|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89901|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89902|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89960|NCT02028676|O2|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
90059|NCT02027402|B3|Baseline|Total|Total of all reporting groups
90060|NCT02027402|B2|Baseline|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
89903|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89904|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89905|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89906|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89907|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89908|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89909|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89910|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89911|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89912|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89961|NCT02028676|O1|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89991|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
90196|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
89913|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89914|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89915|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89916|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89917|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89918|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89919|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89920|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89921|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89962|NCT02028676|O3|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age"
89992|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
89922|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89923|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89924|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89925|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89926|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89927|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89928|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89929|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89930|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89931|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89963|NCT02028676|O2|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
90197|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
90198|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
89932|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89933|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89934|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89935|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89936|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89937|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89938|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89939|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89940|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89941|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89964|NCT02028676|O1|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89993|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
90199|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
89942|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89943|NCT02028676|O3|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age"
89944|NCT02028676|O2|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89945|NCT02028676|O1|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89946|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89947|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89948|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89949|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89950|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89951|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
89952|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
89953|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
89954|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
89955|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89956|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89957|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89958|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89989|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
90200|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
89965|NCT02028676|O3|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age"
89966|NCT02028676|O2|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89967|NCT02028676|O1|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89968|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89969|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89970|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89971|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89972|NCT02028676|E9|Reported Event|Stopped Cotrimoxazole Prophylaxis|"Children had been taking once-daily cotrimoxazole prophylaxis since at least ART initiation. Children randomised to this experimental arm stopped taking cotrimoxazole prophylaxis.~Stopped cotrimoxazole prophylaxis"
89973|NCT02028676|E8|Reported Event|Continued Cotrimoxazole Prophylaxis|"Once-daily doses 5-<15 kg: 200 mg of trimethoprim + 40 mg sulfamethoxazole 15-<30 kg: 400 mg trimethoprim + 80 mg sulfamethoxazole >=30 kg: 800 mg trimethoprim + 160 mg sulfamethoxazole~Continued cotrimoxazole prophylaxis"
89974|NCT02028676|E7|Reported Event|Twice-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO~Twice-daily ABC+3TC"
89975|NCT02028676|E6|Reported Event|Once-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed once-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed once-daily according to weight-bands following WHO~Once-daily ABC+3TC"
89976|NCT02028676|E5|Reported Event|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89990|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
90201|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
89977|NCT02028676|E4|Reported Event|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89978|NCT02028676|E3|Reported Event|Arm A: Abacavir (ABC)+Lamivudine (3TC)+NNRTI|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO non-nucleoside reverse transcriptase inhibitor (NNRTI): either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm A: ABC+3TC+NNRTI: Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
89979|NCT02028676|E2|Reported Event|Laboratory Plus Clinical Monitoring (LCM)|Laboratory plus Clinical Monitoring (LCM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89980|NCT02028676|E1|Reported Event|Clinically Driven Monitoring (CDM)|Clinically Driven Monitoring (CDM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
89981|NCT02028325|B1|Baseline|Fluorescein Sodium|All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
89982|NCT02028325|P1|Participant Flow|Fluorescein Sodium|All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
89983|NCT02028325|O1|Outcome|Fluorescein Sodium|All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
89984|NCT02028325|E1|Reported Event|Fluorescein Sodium|All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
89985|NCT02028169|B1|Baseline|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
89986|NCT02028169|P1|Participant Flow|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed psoriatic arthritis (PsA) for which the physician has initiated treatment with an anti-tumor necrosis factor (TNF).
89987|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
89988|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
89994|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
89995|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
89996|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
89997|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
89998|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
89999|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
90000|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
90001|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
90002|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
90003|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
90004|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
90005|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
90006|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
90007|NCT02028169|E1|Reported Event|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
90008|NCT02028065|B4|Baseline|Total|Total of all reporting groups
90009|NCT02028065|B3|Baseline|Sugammadex 16 mg/kg|Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
90010|NCT02028065|B2|Baseline|Sugammadex 4 mg/kg|Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
90011|NCT02028065|B1|Baseline|Placebo|Administration of 3 single IV doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
90012|NCT02028065|P3|Participant Flow|Sugammadex 16 mg/kg|Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
90013|NCT02028065|P2|Participant Flow|Sugammadex 4 mg/kg|Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
90014|NCT02028065|P1|Participant Flow|Placebo|Administration of 3 single intravenous (IV) doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
90015|NCT02028065|O3|Outcome|Sugammadex 16 mg/kg|Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
90016|NCT02028065|O2|Outcome|Sugammadex 4 mg/kg|Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
90017|NCT02028065|O1|Outcome|Placebo|Administration of 3 single IV doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
90018|NCT02028065|O3|Outcome|Sugammadex 16 mg/kg|Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
90019|NCT02028065|O2|Outcome|Sugammadex 4 mg/kg|Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
90020|NCT02028065|O1|Outcome|Placebo|Administration of 3 single IV doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
90021|NCT02028065|E3|Reported Event|Sugammadex 16 mg/kg|Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
90022|NCT02028065|E2|Reported Event|Sugammadex 4 mg/kg|Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
90023|NCT02028065|E1|Reported Event|Placebo|Administration of 3 single IV doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
90024|NCT02027883|B3|Baseline|Total|Total of all reporting groups
90025|NCT02027883|B2|Baseline|Experimental Parameter|"Educated T shock setting~Educated T shock setting: Experimental Parameter Set 2 Programming Values"
90026|NCT02027883|B1|Baseline|Nominal Parameter|"Nominal T shock setting~Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust"
90027|NCT02027883|P2|Participant Flow|Experimental Parameter|"Educated T shock setting~Educated T shock setting: Experimental Parameter Set 2 Programming Values"
90028|NCT02027883|P1|Participant Flow|Nominal Parameter|"Nominal T shock setting~Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust"
90029|NCT02027883|O2|Outcome|Experimental Parameter|"Educated T shock setting~Educated T shock setting: Experimental Parameter Set 2 Programming Values~The educated T shock setting method was successful in 70% of the patients. 35 out of 50 patients Ventricular Fibrillation was induced with the educated T- shock method. Of the 12 patients that were did not have Ventricular fibrillation induced with the nominal T-shock method, they were all successfully induced with the educated T-Shock method."
90030|NCT02027883|O1|Outcome|Nominal Parameter|"Nominal T shock setting~Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust~The standard T-Shock method was successful in 76% of the patients. 38 out of 50 patients Ventricular Fibrillation was induced with the nominal T shock method. In contrast, 87 % or 13 out of 15 that failed to induce Ventricular Fibrillation using the educated T-Shock method was successfully induced when crossed to the nominal T-shock method."
90031|NCT02027883|O2|Outcome|Experimental Parameter|Educated T shock setting: Experimental Parameter Set 2 Programming Values.
90032|NCT02027883|O1|Outcome|Nominal Parameter|Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust.
90033|NCT02027883|O2|Outcome|Experimental Parameter|"Educated T shock setting~Educated T shock setting: Experimental Parameter Set 2 Programming Values"
90034|NCT02027883|O1|Outcome|Nominal Parameter|"Nominal T shock setting~Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust"
90035|NCT02027883|E2|Reported Event|Experimental Parameter|"Educated T shock setting~Educated T shock setting: Experimental Parameter Set 2 Programming Values"
90036|NCT02027883|E1|Reported Event|Nominal Parameter|"Nominal T shock setting~Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust"
90037|NCT02027844|B4|Baseline|Total|Total of all reporting groups
90038|NCT02027844|B3|Baseline|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane~parental presence: parental presence during inhalational induction of sevoflurane"
90039|NCT02027844|B2|Baseline|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room~parental presence: parental presence during inhalational induction of sevoflurane"
90040|NCT02027844|B1|Baseline|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
90041|NCT02027844|P3|Participant Flow|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane~parental presence: parental presence during inhalational induction of sevoflurane"
90042|NCT02027844|P2|Participant Flow|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room~parental presence: parental presence during inhalational induction of sevoflurane"
90043|NCT02027844|P1|Participant Flow|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
90044|NCT02027844|O3|Outcome|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane~parental presence: parental presence during inhalational induction of sevoflurane"
90045|NCT02027844|O2|Outcome|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room~parental presence: parental presence during inhalational induction of sevoflurane"
90046|NCT02027844|O1|Outcome|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
90047|NCT02027844|O3|Outcome|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane~parental presence: parental presence during inhalational induction of sevoflurane"
90048|NCT02027844|O2|Outcome|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room~parental presence: parental presence during inhalational induction of sevoflurane"
90049|NCT02027844|O1|Outcome|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
90050|NCT02027844|O3|Outcome|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane~parental presence: parental presence during inhalational induction of sevoflurane"
90051|NCT02027844|O2|Outcome|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room~parental presence: parental presence during inhalational induction of sevoflurane"
90052|NCT02027844|O1|Outcome|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
90053|NCT02027844|O3|Outcome|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane~parental presence: parental presence during inhalational induction of sevoflurane"
90054|NCT02027844|O2|Outcome|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room~parental presence: parental presence during inhalational induction of sevoflurane"
90055|NCT02027844|O1|Outcome|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
90056|NCT02027844|E3|Reported Event|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane~parental presence: parental presence during inhalational induction of sevoflurane"
90057|NCT02027844|E2|Reported Event|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room~parental presence: parental presence during inhalational induction of sevoflurane"
90061|NCT02027402|B1|Baseline|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.~Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
90062|NCT02027402|P2|Participant Flow|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
90063|NCT02027402|P1|Participant Flow|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.~Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
90064|NCT02027402|O2|Outcome|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
90065|NCT02027402|O1|Outcome|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.~Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
90066|NCT02027402|O2|Outcome|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
90067|NCT02027402|O1|Outcome|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.~Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
90068|NCT02027402|O2|Outcome|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
90069|NCT02027402|O1|Outcome|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.~Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
90070|NCT02027402|O2|Outcome|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.~Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
90071|NCT02027402|O1|Outcome|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
90072|NCT02027402|E2|Reported Event|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
90073|NCT02027402|E1|Reported Event|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.~Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
90074|NCT02027311|B3|Baseline|Total|Total of all reporting groups
90075|NCT02027311|B2|Baseline|Midazolam|"This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
90076|NCT02027311|B1|Baseline|Etomidate|"This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
90077|NCT02027311|P2|Participant Flow|Midazolam|"This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
90078|NCT02027311|P1|Participant Flow|Etomidate|"This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
90079|NCT02027311|O2|Outcome|Etomidate|"This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
90080|NCT02027311|O1|Outcome|Midazolam|"This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
90202|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
90203|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
90081|NCT02027311|O2|Outcome|Midazolam|"This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
90082|NCT02027311|O1|Outcome|Etomidate|"This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
90083|NCT02027311|E2|Reported Event|Midazolam|"This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
90084|NCT02027311|E1|Reported Event|Etomidate|"This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
90085|NCT02027272|B3|Baseline|Total|Total of all reporting groups
90086|NCT02027272|B2|Baseline|Placebo|Placebo, 2 doses, 12 hours apart
90087|NCT02027272|B1|Baseline|Dexamethasone|"Dexamethasone 12 mg, 2 doses, 12 hours apart.~Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart"
90088|NCT02027272|P2|Participant Flow|Placebo|Placebo, 2 doses, 12 hours apart
90089|NCT02027272|P1|Participant Flow|Dexamethasone|"Dexamethasone 12 mg, 2 doses, 12 hours apart.~Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart"
90090|NCT02027272|O2|Outcome|Placebo|Placebo, 2 doses, 12 hours apart
90091|NCT02027272|O1|Outcome|Dexamethasone|"Dexamethasone 12 mg, 2 doses, 12 hours apart.~Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart"
90092|NCT02027272|E2|Reported Event|Placebo|Placebo, 2 doses, 12 hours apart
90093|NCT02027272|E1|Reported Event|Dexamethasone|"Dexamethasone 12 mg, 2 doses, 12 hours apart.~Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart"
90094|NCT02026453|B4|Baseline|Total|Total of all reporting groups
90095|NCT02026453|B3|Baseline|Pharm Tech Obtains Home Med hx|Pharmacy technician obtains admission medication history, although usual care practices may also continue.
90096|NCT02026453|B2|Baseline|Pharmacist Obtains Home Med hx|Pharmacist obtains admission medication history, although usual care practices may also continue.
90097|NCT02026453|B1|Baseline|Usual Care|Physicians and nurses obtain admission medication history.
90098|NCT02026453|P3|Participant Flow|Pharm Tech Obtains Home Med hx|"Pharmacy technician obtains admission medication history, although usual care practices may also continue.~Pharmacy technician obtains admission medication history"
90099|NCT02026453|P2|Participant Flow|Pharmacist Obtains Home Med hx|"Pharmacist obtains admission medication history, although usual care practices may also continue.~Pharmacist obtains admission medication history"
90100|NCT02026453|P1|Participant Flow|Usual Care|Physicians and nurses obtain admission medication history.
90101|NCT02026453|O3|Outcome|Pharm Tech Obtains Home Med hx|"Pharmacy technician obtains admission medication history, although usual care practices may also continue.~Pharmacy technician obtains admission medication history"
90102|NCT02026453|O2|Outcome|Pharmacist Obtains Home Med hx|"Pharmacist obtains admission medication history, although usual care practices may also continue.~Pharmacist obtains admission medication history"
90103|NCT02026453|O1|Outcome|Usual Care|Physicians and nurses obtain admission medication history.
90104|NCT02026453|O3|Outcome|Pharm Tech Obtains Home Med hx|"Pharmacy technician obtains admission medication history, although usual care practices may also continue.~Pharmacy technician obtains admission medication history"
90105|NCT02026453|O2|Outcome|Pharmacist Obtains Home Med hx|"Pharmacist obtains admission medication history, although usual care practices may also continue.~Pharmacist obtains admission medication history"
90106|NCT02026453|O1|Outcome|Usual Care|Physicians and nurses obtain admission medication history.
90107|NCT02026453|E3|Reported Event|Pharm Tech Obtains Home Med hx|"Pharmacy technician obtains admission medication history, although usual care practices may also continue.~Pharmacy technician obtains admission medication history"
90108|NCT02026453|E2|Reported Event|Pharmacist Obtains Home Med hx|"Pharmacist obtains admission medication history, although usual care practices may also continue.~Pharmacist obtains admission medication history"
90109|NCT02026453|E1|Reported Event|Usual Care|Physicians and nurses obtain admission medication history.
90110|NCT02026258|B3|Baseline|Total|Total of all reporting groups
90147|NCT02026141|B1|Baseline|Dexmedetomidine Arm|"Standardized pre-op meds and spinal anesthetic.~Once the patient's spinal is performed, patient will receive the following:~Start with bolus of 0.5micrgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr~Infusion will be stopped after the last staple or suture is performed on the incision.~Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation as defined by ASA.~Dexmedetomidine"
90204|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
90111|NCT02026258|B2|Baseline|Orthodontics With Piezotome Corticision|"Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be the same as the control orthodontic group. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.~Piezotome-Corticision: A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The depth of the cortical incision will be limited to 1mm for a safety margin.~Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). Archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
90112|NCT02026258|B1|Baseline|Orthodontics no Piezocision|"Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.~Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
90113|NCT02026258|P2|Participant Flow|Orthodontics With Piezotome Corticision|"Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. Time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.~Piezotome-Corticision: Local anesthetic will be administered to the labial sulcus of the mandibular incisors. A scalpel will be used to make three vertical incisions through the gingiva, 4mm below the interdental papilla, interproximally between mandibular canines and lateral incisors, and central incisors on the labial aspect of the mandible. The incisions will be 4mm in length. A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The de"
90114|NCT02026258|P1|Participant Flow|Orthodontics no Piezocision|"Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.~Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
90115|NCT02026258|O2|Outcome|Orthodontics With Piezotome Corticision|"Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be the same as the control orthodontic group. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.~Piezotome-Corticision: A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The depth of the cortical incision will be limited to 1mm for a safety margin.~Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). Archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
90116|NCT02026258|O1|Outcome|Orthodontics no Piezocision|"Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.~Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
90117|NCT02026258|O2|Outcome|Orthodontics With Piezotome Corticision|"Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be the same as the control orthodontic group. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.~Piezotome-Corticision: A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The depth of the cortical incision will be limited to 1mm for a safety margin.~Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). Archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
90118|NCT02026258|O1|Outcome|Orthodontics no Piezocision|"Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.~Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
90205|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
90206|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
90207|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
90119|NCT02026258|O2|Outcome|Orthodontics With Piezotome Corticision|"Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be the same as the control orthodontic group. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.~Piezotome-Corticision: A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The depth of the cortical incision will be limited to 1mm for a safety margin.~Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). Archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
90120|NCT02026258|O1|Outcome|Orthodontics no Piezocision|"Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.~Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
90121|NCT02026258|O2|Outcome|Orthodontics With Piezotome Corticision|"Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be the same as the control orthodontic group. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.~Piezotome-Corticision: A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The depth of the cortical incision will be limited to 1mm for a safety margin.~Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). Archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
90122|NCT02026258|O1|Outcome|Orthodontics no Piezocision|"Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.~Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
90123|NCT02026258|E2|Reported Event|Orthodontics With Piezotome Corticision|"Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.~Piezotome-Corticision: Local anesthetic will be administered to the labial sulcus of the mandibular incisors. A scalpel will be used to make three vertical incisions through the gingiva, 4mm below the interdental papilla, interproximally between mandibular canines and lateral incisors, and central incisors on the labial aspect of the mandible. The incisions will be 4mm in length. A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone."
90124|NCT02026258|E1|Reported Event|Orthodontics no Piezocision|"Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.~Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
90125|NCT02026206|B3|Baseline|Total|Total of all reporting groups
90126|NCT02026206|B2|Baseline|Placebo-controlled Group|"Placebo low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.~Placebo: we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
90127|NCT02026206|B1|Baseline|LLLT Group|"low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles.~low-level light therapy: we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
90148|NCT02026141|P2|Participant Flow|Saline Placebo|"Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed,~Patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo.~midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Normal Saline Placebo"
90208|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
90209|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
90128|NCT02026206|P2|Participant Flow|Placebo-controlled Group|"Placebo low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.~Placebo: we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
90129|NCT02026206|P1|Participant Flow|LLLT Group|"low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles.~low-level light therapy: we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
90130|NCT02026206|O2|Outcome|Placebo-controlled Group|"Placebo low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.~Placebo: we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
90131|NCT02026206|O1|Outcome|LLLT Group|"low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles.~low-level light therapy: we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
90132|NCT02026206|O2|Outcome|Placebo-controlled Group|"Placebo low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.~Placebo: we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
90133|NCT02026206|O1|Outcome|LLLT Group|"low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles.~low-level light therapy: we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
90134|NCT02026206|E2|Reported Event|Placebo-controlled Group|"Placebo low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.~Placebo: we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
90135|NCT02026206|E1|Reported Event|LLLT Group|"low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles.~low-level light therapy: we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
90136|NCT02026193|B3|Baseline|Total|Total of all reporting groups
90137|NCT02026193|B2|Baseline|Embryo Freezing|"All retrieved oocytes will be fertilized, and resulting embryos will be frozen.~embryo freezing"
90138|NCT02026193|B1|Baseline|Oocyte Vitrification|"All retrieved mature oocytes will be vitrified.~oocyte vitrification"
90139|NCT02026193|P2|Participant Flow|Embryo Freezing|"All retrieved oocytes will be fertilized, and resulting embryos will be frozen.~embryo freezing"
90140|NCT02026193|P1|Participant Flow|Oocyte Vitrification|"All retrieved mature oocytes will be vitrified.~oocyte vitrification"
90141|NCT02026193|O2|Outcome|Embryo Freezing|"All retrieved oocytes will be fertilized, and resulting embryos will be frozen.~embryo freezing"
90142|NCT02026193|O1|Outcome|Oocyte Vitrification|"All retrieved mature oocytes will be vitrified.~oocyte vitrification"
90143|NCT02026193|E2|Reported Event|Embryo Freezing|"All retrieved oocytes will be fertilized, and resulting embryos will be frozen.~embryo freezing"
90144|NCT02026193|E1|Reported Event|Oocyte Vitrification|"All retrieved mature oocytes will be vitrified.~oocyte vitrification"
90145|NCT02026141|B3|Baseline|Total|Total of all reporting groups
90146|NCT02026141|B2|Baseline|Saline Placebo|"Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed,~Patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo.~midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Normal Saline Placebo"
90187|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
90149|NCT02026141|P1|Participant Flow|Dexmedetomidine Arm|"Standardized pre-op meds and spinal anesthetic.~Once the patient's spinal is performed, patient will receive the following:~Start with bolus of 0.5micrgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr Infusion will be stopped after the last staple or suture is performed on the incision.~Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Dexmedetomidine"
90150|NCT02026141|O2|Outcome|Saline Placebo|"Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed,~Patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo.~midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Normal Saline Placebo"
90151|NCT02026141|O1|Outcome|Dexmedetomidine Arm|"Standardized pre-op meds and spinal anesthetic.~Once the patient's spinal is performed, patient will receive the following:~Start with bolus of 0.5micrgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr Infusion will be stopped after the last staple or suture is performed on the incision.~Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Dexmedetomidine"
90152|NCT02026141|E2|Reported Event|Saline Placebo|"Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed,~Patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo.~midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Normal Saline Placebo"
90153|NCT02026141|E1|Reported Event|Dexmedetomidine Arm|"Standardized pre-op meds and spinal anesthetic.~Once the patient's spinal is performed, patient will receive the following:~Start with bolus of 0.5micrgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr Infusion will be stopped after the last staple or suture is performed on the incision.~Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Dexmedetomidine"
90154|NCT02025907|B3|Baseline|Total|Total of all reporting groups
90155|NCT02025907|B2|Baseline|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
90156|NCT02025907|B1|Baseline|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
90157|NCT02025907|P2|Participant Flow|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
90158|NCT02025907|P1|Participant Flow|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
90159|NCT02025907|O2|Outcome|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
90160|NCT02025907|O1|Outcome|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
90161|NCT02025907|O2|Outcome|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
90162|NCT02025907|O1|Outcome|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
90163|NCT02025907|O2|Outcome|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
90164|NCT02025907|O1|Outcome|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
90165|NCT02025907|O2|Outcome|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
90166|NCT02025907|O1|Outcome|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
90167|NCT02025907|O2|Outcome|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
90168|NCT02025907|O1|Outcome|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
90169|NCT02025907|E2|Reported Event|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
90170|NCT02025907|E1|Reported Event|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
90171|NCT02025829|B3|Baseline|Total|Total of all reporting groups
90172|NCT02025829|B2|Baseline|Exacerbation|Patients with cystic fibrosis admitted for treatment of a pulmonary exacerbation with IV antibiotics, 10 subjects with one copy of F508del
90173|NCT02025829|B1|Baseline|Clinically Stable|Patients with cystic fibrosis and are clinically stable, 10 subjects with one copy of F508del and 4 subjects with at least one copy of G551D
90174|NCT02025829|P2|Participant Flow|Exacerbation|Patients with cystic fibrosis admitted for treatment of a pulmonary exacerbation with IV antibiotics, 10 subjects with one copy of F508del
90175|NCT02025829|P1|Participant Flow|Clinically Stable|Patients with cystic fibrosis and are clinically stable, 10 subjects with one copy of F508del and 4 subjects with at least one copy of G551D
90176|NCT02025829|O2|Outcome|End of Exacerbation|Study volunteer at the completion of 2 weeks IV antibiotic treatment for a pulmonary exacerbation
90177|NCT02025829|O1|Outcome|Begining of Exacerbation|Study volunteer at the beginning of IV antibiotic treatment for a pulmonary exacerbation
90178|NCT02025829|O1|Outcome|Clinically Stable Cohort|Clinically stable subjects
90179|NCT02025829|O2|Outcome|End of Exacerbation|Study volunteer at the completion of 2 weeks IV antibiotic treatment for a pulmonary exacerbation
90180|NCT02025829|O1|Outcome|Begining of Exacerbation|Study volunteer at the beginning of IV antibiotic treatment for a pulmonary exacerbation
90181|NCT02025829|E2|Reported Event|Exacerbation|Patients with cystic fibrosis admitted for treatment of a pulmonary exacerbation with IV antibiotics, 10 subjects with one copy of F508del
90182|NCT02025829|E1|Reported Event|Clinically Stable|Patients with cystic fibrosis and are clinically stable, 10 subjects with one copy of F508del and 4 subjects with at least one copy of G551D
90183|NCT02025647|B1|Baseline|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
90184|NCT02025647|P1|Participant Flow|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
90185|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
90186|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
90210|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
90211|NCT02025647|E1|Reported Event|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
90212|NCT02025621|B3|Baseline|Total|Total of all reporting groups
90213|NCT02025621|B2|Baseline|Placebo|"placebo 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Placebo: matching placebo"
90214|NCT02025621|B1|Baseline|Levosimendan|"levosimendan 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Levosimendan"
90215|NCT02025621|P2|Participant Flow|Placebo|"placebo 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Placebo: matching placebo"
90216|NCT02025621|P1|Participant Flow|Levosimendan|"levosimendan 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Levosimendan"
90217|NCT02025621|O2|Outcome|Placebo|"placebo 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Placebo: matching placebo"
90218|NCT02025621|O1|Outcome|Levosimendan|"levosimendan 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Levosimendan"
90219|NCT02025621|O2|Outcome|Placebo|"placebo 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Placebo: matching placebo"
90220|NCT02025621|O1|Outcome|Levosimendan|"levosimendan 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Levosimendan"
90221|NCT02025621|O2|Outcome|Placebo|"placebo 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Placebo: matching placebo"
90222|NCT02025621|O1|Outcome|Levosimendan|"levosimendan 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Levosimendan"
90223|NCT02025621|O2|Outcome|Placebo|"placebo 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Placebo: matching placebo"
90224|NCT02025621|O1|Outcome|Levosimendan|"levosimendan 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Levosimendan"
90225|NCT02025621|O2|Outcome|Placebo|"placebo 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Placebo: matching placebo"
90226|NCT02025621|O1|Outcome|Levosimendan|"levosimendan 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Levosimendan"
90227|NCT02025621|O2|Outcome|Placebo|"placebo 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Placebo: matching placebo"
90228|NCT02025621|O1|Outcome|Levosimendan|"levosimendan 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Levosimendan"
90229|NCT02025621|O2|Outcome|Placebo|"placebo 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Placebo: matching placebo"
90230|NCT02025621|O1|Outcome|Levosimendan|"levosimendan 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Levosimendan"
90231|NCT02025621|E2|Reported Event|Placebo|"placebo 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Placebo: matching placebo"
90232|NCT02025621|E1|Reported Event|Levosimendan|"levosimendan 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours~Levosimendan"
90233|NCT02025075|B3|Baseline|Total|Total of all reporting groups
90234|NCT02025075|B2|Baseline|Moderate Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 twitches in the train-on-four (neuromuscular function monitor).~Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
90235|NCT02025075|B1|Baseline|Deep Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (neuromuscular function monitor).~Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
90236|NCT02025075|P2|Participant Flow|Moderate Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 twitches in the train-on-four (neuromuscular function monitor).~Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
90237|NCT02025075|P1|Participant Flow|Deep Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (neuromuscular function monitor).~Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
90238|NCT02025075|O2|Outcome|Moderate Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 twitches in the train-on-four (neuromuscular function monitor).~Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
90239|NCT02025075|O1|Outcome|Deep Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (neuromuscular function monitor).~Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
90240|NCT02025075|O6|Outcome|Moderate Neuromuscular Block (NMB): MOD(2nd) of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): MODERATE (2nd TOF1) of TOF1-Deep-TOF1 group
90241|NCT02025075|O5|Outcome|Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1 group
90242|NCT02025075|O4|Outcome|Moderate Neuromuscular Block (NMB): MOD(1st) of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): MODERATE (1st TOF1) of TOF1-Deep-TOF1 group
90243|NCT02025075|O3|Outcome|Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep group
90244|NCT02025075|O2|Outcome|Deep Neuromuscular Block (NMB): MODERATE of of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): MODERATE (TOF1) of Deep-TOF1-Deep group
90245|NCT02025075|O1|Outcome|Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep group
90246|NCT02025075|O6|Outcome|Moderate Neuromuscular Block (NMB): MOD(2nd) of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): MODERATE (2nd TOF1) of TOF1-Deep-TOF1 group
90247|NCT02025075|O5|Outcome|Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1 group
90248|NCT02025075|O4|Outcome|Moderate Neuromuscular Block (NMB): MOD(1st) of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): MODERATE (1st TOF1) of TOF1-Deep-TOF1 group
90249|NCT02025075|O3|Outcome|Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep group
90250|NCT02025075|O2|Outcome|Deep Neuromuscular Block (NMB): MODERATE of of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): MODERATE (TOF1) of Deep-TOF1-Deep group
90251|NCT02025075|O1|Outcome|Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep group
90252|NCT02025075|O6|Outcome|Moderate Neuromuscular Block (NMB): MOD(2nd) of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): MODERATE (2nd TOF1) of TOF1-Deep-TOF1 group
90253|NCT02025075|O5|Outcome|Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1 group
90254|NCT02025075|O4|Outcome|Moderate Neuromuscular Block (NMB): MOD(1st) of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): MODERATE (1st TOF1) of TOF1-Deep-TOF1 group
90255|NCT02025075|O3|Outcome|Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep group
90256|NCT02025075|O2|Outcome|Deep Neuromuscular Block (NMB): MODERATE of of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): MODERATE (TOF1) of Deep-TOF1-Deep group
90257|NCT02025075|O1|Outcome|Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep group
90258|NCT02025075|E2|Reported Event|Moderate Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 twitches in the train-on-four (neuromuscular function monitor).~Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
90259|NCT02025075|E1|Reported Event|Deep Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (neuromuscular function monitor).~Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
90260|NCT02024971|B1|Baseline|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
90261|NCT02024971|P1|Participant Flow|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
90262|NCT02024971|O1|Outcome|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
90263|NCT02024971|O1|Outcome|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
90264|NCT02024971|O1|Outcome|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
90265|NCT02024971|O1|Outcome|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
90266|NCT02024971|E1|Reported Event|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
90267|NCT02024932|B7|Baseline|Total|Total of all reporting groups
90268|NCT02024932|B6|Baseline|Placebo Part B Double Blind (Cohort 5)|Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.
90269|NCT02024932|B5|Baseline|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
90270|NCT02024932|B4|Baseline|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
90271|NCT02024932|B3|Baseline|Placebo Part A Double Blind (Cohort 2)|Participants received single doses of matching placebo i.v. on day 1 and matching placebo s.c. on days 15, 29, 43 and 57.
90272|NCT02024932|B2|Baseline|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
90273|NCT02024932|B1|Baseline|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
90274|NCT02024932|P6|Participant Flow|Placebo Part B Double Blind (Cohort 5)|Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.
90275|NCT02024932|P5|Participant Flow|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
90276|NCT02024932|P4|Participant Flow|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
90277|NCT02024932|P3|Participant Flow|Placebo Part A Double Blind (Cohort 2)|Participants received single doses of matching placebo i.v. on day 1 and matching placebo s.c. on days 15, 29, 43 and 57.
90278|NCT02024932|P2|Participant Flow|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
90279|NCT02024932|P1|Participant Flow|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
90280|NCT02024932|O4|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
90281|NCT02024932|O3|Outcome|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
90282|NCT02024932|O2|Outcome|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
91054|NCT02020616|O1|Outcome|Placebo|Placebo administered SC QW for 12 weeks
90283|NCT02024932|O1|Outcome|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
90284|NCT02024932|O4|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
90285|NCT02024932|O3|Outcome|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
90286|NCT02024932|O2|Outcome|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
90287|NCT02024932|O1|Outcome|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
90288|NCT02024932|O4|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
90289|NCT02024932|O3|Outcome|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
90290|NCT02024932|O2|Outcome|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
90291|NCT02024932|O1|Outcome|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
90292|NCT02024932|O4|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
90293|NCT02024932|O3|Outcome|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
90294|NCT02024932|O2|Outcome|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
90295|NCT02024932|O1|Outcome|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
90296|NCT02024932|O1|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
90297|NCT02024932|O1|Outcome|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
90298|NCT02024932|O1|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
90299|NCT02024932|O1|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
90300|NCT02024932|O1|Outcome|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
90301|NCT02024932|O1|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
90302|NCT02024932|O1|Outcome|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
90303|NCT02024932|O1|Outcome|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
90304|NCT02024932|O1|Outcome|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
90305|NCT02024932|O1|Outcome|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
90306|NCT02024932|O1|Outcome|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
90307|NCT02024932|O1|Outcome|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
90308|NCT02024932|O1|Outcome|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
90309|NCT02024932|O1|Outcome|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
90310|NCT02024932|O1|Outcome|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
90311|NCT02024932|O2|Outcome|Placebo Part B Double Blind (Cohort 5)|Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.
90312|NCT02024932|O1|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
90313|NCT02024932|O2|Outcome|Placebo Part B Double Blind (Cohort 5)|Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.
90314|NCT02024932|O1|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
90315|NCT02024932|O2|Outcome|Placebo Part B Double Blind (Cohort 5)|Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.
90316|NCT02024932|O1|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
90317|NCT02024932|O6|Outcome|Placebo Part B Double Blind (Cohort 5)|Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.
90318|NCT02024932|O5|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
90319|NCT02024932|O4|Outcome|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
90320|NCT02024932|O3|Outcome|Placebo Part A Double Blind (Cohort 2)|Participants received single doses of matching placebo i.v. on day 1 and matching placebo s.c. on days 15, 29, 43 and 57.
90321|NCT02024932|O2|Outcome|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
90322|NCT02024932|O1|Outcome|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
90323|NCT02024932|O6|Outcome|Placebo Part B Double Blind (Cohort 5)|Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.
90324|NCT02024932|O5|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
90325|NCT02024932|O4|Outcome|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
90326|NCT02024932|O3|Outcome|Placebo Part A Double Blind (Cohort 2)|Participants received single doses of matching placebo i.v. on day 1 and matching placebo s.c. on days 15, 29, 43 and 57.
90327|NCT02024932|O2|Outcome|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
90328|NCT02024932|O1|Outcome|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
90329|NCT02024932|E6|Reported Event|Placebo Part B Double Blind (Cohort 5)|Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.
90330|NCT02024932|E5|Reported Event|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
90331|NCT02024932|E4|Reported Event|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
90332|NCT02024932|E3|Reported Event|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
90333|NCT02024932|E2|Reported Event|Placebo Part A Double Blind (Cohort 2)|Participants received single doses of matching placebo i.v. on day 1 and matching placebo s.c. on days 15, 29, 43 and 57.
90334|NCT02024932|E1|Reported Event|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
90335|NCT02024867|B3|Baseline|Total|Total of all reporting groups
90336|NCT02024867|B2|Baseline|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
90337|NCT02024867|B1|Baseline|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
90338|NCT02024867|P2|Participant Flow|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
90339|NCT02024867|P1|Participant Flow|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
90340|NCT02024867|O2|Outcome|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
90341|NCT02024867|O1|Outcome|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
90342|NCT02024867|O2|Outcome|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
90343|NCT02024867|O1|Outcome|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
90344|NCT02024867|O2|Outcome|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
90345|NCT02024867|O1|Outcome|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
90346|NCT02024867|O2|Outcome|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
90347|NCT02024867|O1|Outcome|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
90348|NCT02024867|O2|Outcome|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
90349|NCT02024867|O1|Outcome|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
90350|NCT02024867|O2|Outcome|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
90351|NCT02024867|O1|Outcome|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
90352|NCT02024867|E2|Reported Event|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
90353|NCT02024867|E1|Reported Event|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
90354|NCT02024724|B3|Baseline|Total|Total of all reporting groups
90355|NCT02024724|B2|Baseline|Group 1|"40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine~Bupivacaine: 4 mL of 0.25% bupivacaine~Triamcinolone: 40 mg of Triamcinolone"
90356|NCT02024724|B1|Baseline|Group 2|"4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine~Bupivacaine: 4 mL of 0.25% bupivacaine~Dexamethasone: 4 mg of Dexamethasone"
90357|NCT02024724|P2|Participant Flow|Group 1|"40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine~Bupivacaine: 4 mL of 0.25% bupivacaine~Triamcinolone: 40 mg of Triamcinolone"
90358|NCT02024724|P1|Participant Flow|Group 2|"4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine~Bupivacaine: 4 mL of 0.25% bupivacaine~Dexamethasone: 4 mg of Dexamethasone"
90359|NCT02024724|O2|Outcome|Group 2|"40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine~Bupivacaine: 4 mL of 0.25% bupivacaine~Triamcinolone: 40 mg of Triamcinolone"
90360|NCT02024724|O1|Outcome|Group 1|"4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine~Bupivacaine: 4 mL of 0.25% bupivacaine~Dexamethasone: 4 mg of Dexamethasone"
90361|NCT02024724|E2|Reported Event|Group 2|"40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine~Bupivacaine: 4 mL of 0.25% bupivacaine~Triamcinolone: 40 mg of Triamcinolone"
90362|NCT02024724|E1|Reported Event|Group 1|"4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine~Bupivacaine: 4 mL of 0.25% bupivacaine~Dexamethasone: 4 mg of Dexamethasone"
90363|NCT02024698|B1|Baseline|Overall Study Group|Study participants are randomized to wear omafilcon A or etafilcon A pair of study lenses then crossover to the alternate pair.
90364|NCT02024698|P2|Participant Flow|Omafilcon A First, Then Etafilcon A|Study participants are randomized to wear omafilcon A pair of study lenses then crossover to the alternate pair.
90365|NCT02024698|P1|Participant Flow|Etafilcon A First, Then Omafilcon A|Study participants are randomized to wear etafilcon A pair of study lenses then crossover to the alternate pair.
90366|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
90367|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
90368|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
90369|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
90370|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
90371|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
90372|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
90373|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
90374|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
90375|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
90376|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
90377|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
90378|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
90379|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
90380|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
90381|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
90382|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
90383|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
90384|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
90385|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
90386|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
90387|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
90388|NCT02024698|E2|Reported Event|Etafilcon A|Study participants are randomized to wear etafilcon A lenses.
90389|NCT02024698|E1|Reported Event|Omafilcon A|Study participants are randomized to wear omafilcon A lenses.
90390|NCT02024386|B4|Baseline|Total|Total of all reporting groups
90391|NCT02024386|B3|Baseline|Control Arm|"No drug~After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
90392|NCT02024386|B2|Baseline|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
90393|NCT02024386|B1|Baseline|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
90394|NCT02024386|P3|Participant Flow|Control Arm|"No drug~After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
90395|NCT02024386|P2|Participant Flow|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
90424|NCT02023983|B2|Baseline|Standard Discharge|Standard discharge: Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)
90396|NCT02024386|P1|Participant Flow|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
90397|NCT02024386|O3|Outcome|Control Arm|"No drug~After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
90398|NCT02024386|O2|Outcome|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
90399|NCT02024386|O1|Outcome|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
90400|NCT02024386|O3|Outcome|Control Arm|"No drug~After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
90401|NCT02024386|O2|Outcome|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
90402|NCT02024386|O1|Outcome|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
90403|NCT02024386|O3|Outcome|Control Arm|"No drug~After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
90404|NCT02024386|O2|Outcome|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
90405|NCT02024386|O1|Outcome|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
90406|NCT02024386|O3|Outcome|Control Arm|"No drug~After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
90407|NCT02024386|O2|Outcome|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
90408|NCT02024386|O1|Outcome|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
90409|NCT02024386|O3|Outcome|Control Arm|"No drug~After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
90410|NCT02024386|O2|Outcome|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
90411|NCT02024386|O1|Outcome|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
90412|NCT02024386|O3|Outcome|Control Arm|"No drug~After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
90413|NCT02024386|O2|Outcome|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
90414|NCT02024386|O1|Outcome|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
90415|NCT02024386|E3|Reported Event|Control Arm|"No drug~After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
90416|NCT02024386|E2|Reported Event|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. Riociguat will be administered at the 90-minute mark of this rest period. A second VO2 max test will be repeated at altitude."
90417|NCT02024386|E1|Reported Event|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. Riociguat will be administered at the 90-minute mark of this rest period. A second VO2 max test will be repeated at altitude."
90418|NCT02024165|B1|Baseline|Electrode Sensor, FSE, Ultrasound|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor and/or FSE and Ultrasound
90419|NCT02024165|P1|Participant Flow|Electrode Sensor, FSE, Ultrasound|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, and/or FSE and Ultrasound
90420|NCT02024165|O2|Outcome|Electrode Sensor, Ultrasound|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, and/or Ultrasound
90421|NCT02024165|O1|Outcome|Electrode Sensor, FSE|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, and/or FSE
90422|NCT02024165|E1|Reported Event|Electrode Sensor, FSE, Ultrasound|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor and/or FSE and ultrasound
90423|NCT02023983|B3|Baseline|Total|Total of all reporting groups
90571|NCT02023125|B3|Baseline|Total|Total of all reporting groups
90425|NCT02023983|B1|Baseline|Early Discharge|Early discharge: Early discharge (within 72 hours) of selected patients with low risk of complications after myocardial infarction with ST segment elevation, treated with successful percutaneous coronary intervention
90426|NCT02023983|P2|Participant Flow|Standard Discharge|Standard discharge: Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)
90427|NCT02023983|P1|Participant Flow|Early Discharge|Early discharge: Early discharge (within 72 hours) of selected patients with low risk of complications after myocardial infarction with ST segment elevation, treated with successful percutaneous coronary intervention
90428|NCT02023983|O2|Outcome|Standard Discharge|Standard discharge: Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)
90429|NCT02023983|O1|Outcome|Early Discharge|Early discharge: Early discharge (within 72 hours) of selected patients with low risk of complications after myocardial infarction with ST segment elevation, treated with successful percutaneous coronary intervention
90430|NCT02023983|O2|Outcome|Standard Discharge|Standard discharge: Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)
90431|NCT02023983|O1|Outcome|Early Discharge|Early discharge: Early discharge (within 72 hours) of selected patients with low risk of complications after myocardial infarction with ST segment elevation, treated with successful percutaneous coronary intervention
90432|NCT02023983|E2|Reported Event|Standard Discharge|Standard discharge: Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)
90433|NCT02023983|E1|Reported Event|Early Discharge|Early discharge: Early discharge (within 72 hours) of selected patients with low risk of complications after myocardial infarction with ST segment elevation, treated with successful percutaneous coronary intervention
90434|NCT02023918|B1|Baseline|Pegvisomant Arm|pegvisomant: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.
90435|NCT02023918|P1|Participant Flow|Pegvisomant Arm|"Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.~pegvisomant: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study."
90436|NCT02023918|O1|Outcome|Pegvisomant Arm|Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.
90437|NCT02023918|O1|Outcome|Pegvisomant Arm|Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.
90438|NCT02023918|E1|Reported Event|Pegvisomant Arm|pegvisomant: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.
90439|NCT02023879|B4|Baseline|Total|Total of all reporting groups
90440|NCT02023879|B3|Baseline|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90441|NCT02023879|B2|Baseline|Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90442|NCT02023879|B1|Baseline|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90443|NCT02023879|P3|Participant Flow|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection every 4 weeks (Q4W) alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90444|NCT02023879|P2|Participant Flow|Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90445|NCT02023879|P1|Participant Flow|Placebo Q2W|Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
90446|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90447|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90448|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90449|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90450|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90451|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90452|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90453|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90454|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90455|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90456|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90457|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90458|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90459|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90460|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90461|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90462|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90463|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90464|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90465|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90466|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90467|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90468|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90469|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90470|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90471|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90472|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90659|NCT02023099|P3|Participant Flow|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
90473|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90474|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90475|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90476|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90477|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90478|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90479|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90480|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90481|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90482|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90483|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90484|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90485|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90486|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90487|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90488|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90489|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90490|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90491|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90492|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90493|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90660|NCT02023099|P2|Participant Flow|Substudy 1, Arm B: DB Placebo, Followed by OL 2-DAA|DB placebo QD for 12 weeks followed by open-label (OL) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
90494|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90495|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90496|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90497|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90498|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90499|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90500|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90501|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90502|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90503|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90504|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90505|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90506|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90507|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90508|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90509|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90510|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90511|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90512|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90513|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90514|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90661|NCT02023099|P1|Participant Flow|Substudy 1, Arm A: DB 2-DAA|Double-blind (DB) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2 direct-acting antiviral agents [2-DAA]) once daily (QD) for 12 weeks in participants without cirrhosis
91055|NCT02020616|O7|Outcome|2 mg Exenatide ER|2 mg exenatide ER administered SC QW for 12 weeks
90515|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90516|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90517|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90518|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90519|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90520|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90521|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90522|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
90523|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
90524|NCT02023879|E3|Reported Event|Alirocumab 150 Q4W/Up150 Q2W|Participants exposed to alirocumab 150 mg Q4W/up to 150 mg Q2W SC injection added to stable non-statin LMT or diet alone (mean exposure of 22 weeks).
90525|NCT02023879|E2|Reported Event|Alirocumab 75 Q2W/Up150 Q2W|Participants exposed to alirocumab 75 mg Q2W/up to 150 mg Q2W SC injection added to stable non-statin LMT or diet alone (mean exposure of 23 weeks).
90526|NCT02023879|E1|Reported Event|Placebo Q2W|Participants exposed to placebo SC injection Q2W added to stable non-statin LMT or diet alone (mean exposure of 23 weeks).
90527|NCT02023866|B1|Baseline|Cysteamine Bitartrate Delayed-release|Cysteamine bitartrate delayed-release capsules were administered twice daily following a dose-escalation design with a progressive weekly dose increase over the first 6 weeks. The starting dose was 0.2 g/m²/day, up to a maximum dose of 1.3 g/m²/day. Participants remained on their highest tolerated dose until Week 24.
90528|NCT02023866|P1|Participant Flow|Cysteamine Bitartrate Delayed-release|Cysteamine bitartrate delayed-release capsules were administered twice daily following a dose-escalation design with a progressive weekly dose increase over the first 6 weeks. The starting dose was 0.2 g/m²/day, up to a maximum dose of 1.3 g/m²/day. Participants remained on their highest tolerated dose until Week 24.
90529|NCT02023866|O1|Outcome|Cysteamine Bitartrate Delayed-release|Cysteamine bitartrate delayed-release capsules were administered twice daily following a dose-escalation design with a progressive weekly dose increase over the first 6 weeks. The starting dose was 0.2 g/m²/day, up to a maximum dose of 1.3 g/m²/day. Participants remained on their highest tolerated dose until Week 24.
90530|NCT02023866|O1|Outcome|Cysteamine Bitartrate Delayed-release|Cysteamine bitartrate delayed-release capsules were administered twice daily following a dose-escalation design with a progressive weekly dose increase over the first 6 weeks. The starting dose was 0.2 g/m²/day, up to a maximum dose of 1.3 g/m²/day. Participants remained on their highest tolerated dose until Week 24.
90531|NCT02023866|O1|Outcome|Cysteamine Bitartrate Delayed-release|Cysteamine bitartrate delayed-release capsules were administered twice daily following a dose-escalation design with a progressive weekly dose increase over the first 6 weeks. The starting dose was 0.2 g/m²/day, up to a maximum dose of 1.3 g/m²/day. Participants remained on their highest tolerated dose until Week 24.
90532|NCT02023866|O1|Outcome|Cysteamine Bitartrate Delayed-release|Cysteamine bitartrate delayed-release capsules were administered twice daily following a dose-escalation design with a progressive weekly dose increase over the first 6 weeks. The starting dose was 0.2 g/m²/day, up to a maximum dose of 1.3 g/m²/day. Participants remained on their highest tolerated dose until Week 24.
90533|NCT02023866|O1|Outcome|Cysteamine Bitartrate Delayed-release|Cysteamine bitartrate delayed-release capsules were administered twice daily following a dose-escalation design with a progressive weekly dose increase over the first 6 weeks. The starting dose was 0.2 g/m²/day, up to a maximum dose of 1.3 g/m²/day. Participants remained on their highest tolerated dose until Week 24.
90534|NCT02023866|O1|Outcome|Cysteamine Bitartrate Delayed-release|Cysteamine bitartrate delayed-release capsules were administered twice daily following a dose-escalation design with a progressive weekly dose increase over the first 6 weeks. The starting dose was 0.2 g/m²/day, up to a maximum dose of 1.3 g/m²/day. Participants remained on their highest tolerated dose until Week 24.
90535|NCT02023866|O1|Outcome|Cysteamine Bitartrate Delayed-release|Cysteamine bitartrate delayed-release capsules were administered twice daily following a dose-escalation design with a progressive weekly dose increase over the first 6 weeks. The starting dose was 0.2 g/m²/day, up to a maximum dose of 1.3 g/m²/day. Participants remained on their highest tolerated dose until Week 24.
90662|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
91056|NCT02020616|O6|Outcome|200 mg LY3053102|200 mg LY3053102 administered SC QW for 12 weeks
90536|NCT02023866|O1|Outcome|Cysteamine Bitartrate Delayed-release|Cysteamine bitartrate delayed-release capsules were administered twice daily following a dose-escalation design with a progressive weekly dose increase over the first 6 weeks. The starting dose was 0.2 g/m²/day, up to a maximum dose of 1.3 g/m²/day. Participants remained on their highest tolerated dose until Week 24.
90537|NCT02023866|O1|Outcome|Cysteamine Bitartrate Delayed-release|Cysteamine bitartrate delayed-release capsules were administered twice daily following a dose-escalation design with a progressive weekly dose increase over the first 6 weeks. The starting dose was 0.2 g/m²/day, up to a maximum dose of 1.3 g/m²/day. Participants remained on their highest tolerated dose until Week 24.
90538|NCT02023866|O1|Outcome|Cysteamine Bitartrate Delayed-release|Cysteamine bitartrate delayed-release capsules were administered twice daily following a dose-escalation design with a progressive weekly dose increase over the first 6 weeks. The starting dose was 0.2 g/m²/day, up to a maximum dose of 1.3 g/m²/day. Participants remained on their highest tolerated dose until Week 24.
90539|NCT02023866|E1|Reported Event|Cysteamine Bitartrate Delayed-release|Cysteamine bitartrate delayed-release capsules were administered twice daily following a dose-escalation design with a progressive weekly dose increase over the first 6 weeks. The starting dose was 0.2 g/m²/day, up to a maximum dose of 1.3 g/m²/day. Participants remained on their highest tolerated dose until Week 24.
90540|NCT02023801|B1|Baseline|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
90541|NCT02023801|P1|Participant Flow|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
90542|NCT02023801|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
90543|NCT02023801|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
90544|NCT02023801|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
90545|NCT02023801|E1|Reported Event|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
90546|NCT02023515|B3|Baseline|Total|Total of all reporting groups
90547|NCT02023515|B2|Baseline|Standard Behavioral Weight Loss|"Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks~Behavioral weight loss: Standard behavioral weight loss"
90548|NCT02023515|B1|Baseline|Stress Management|"Approximately half of the participants will be randomized to a stress management arm. Participants will undergo Emotional Brain Training during a 90 minute session once per week for ten weeks in order to rewire the brain and improve stress management techniques.~Emotional brain training: Stress management based program"
90549|NCT02023515|P2|Participant Flow|Standard Behavioral Weight Loss|"Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks~Behavioral weight loss: Standard behavioral weight loss"
90550|NCT02023515|P1|Participant Flow|Stress Management|"Approximately half of the participants will be randomized to a stress management arm. Participants will undergo Emotional Brain Training during a 90 minute session once per week for ten weeks in order to rewire the brain and improve stress management techniques.~Emotional brain training: Stress management based program"
90551|NCT02023515|O2|Outcome|Standard Behavioral Weight Loss|"Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks~Behavioral weight loss: Standard behavioral weight loss"
90552|NCT02023515|O1|Outcome|Stress Management|"Approximately half of the participants will be randomized to a stress management arm. Participants will undergo Emotional Brain Training during a 90 minute session once per week for ten weeks in order to rewire the brain and improve stress management techniques.~Emotional brain training: Stress management based program"
90553|NCT02023515|O2|Outcome|Standard Behavioral Weight Loss|"Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks~Behavioral weight loss: Standard behavioral weight loss"
90554|NCT02023515|O1|Outcome|Stress Management|"Approximately half of the participants will be randomized to a stress management arm. Participants will undergo Emotional Brain Training during a 90 minute session once per week for ten weeks in order to rewire the brain and improve stress management techniques.~Emotional brain training: Stress management based program"
90555|NCT02023515|E2|Reported Event|Standard Behavioral Weight Loss|"Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks~Behavioral weight loss: Standard behavioral weight loss"
90556|NCT02023515|E1|Reported Event|Stress Management|"Approximately half of the participants will be randomized to a stress management arm. Participants will undergo Emotional Brain Training during a 90 minute session once per week for ten weeks in order to rewire the brain and improve stress management techniques.~Emotional brain training: Stress management based program"
90557|NCT02023268|B3|Baseline|Total|Total of all reporting groups
90558|NCT02023268|B2|Baseline|Vismed®|Vismed®: 1 drop in each eye 3 to 6 times daily during 84 days
90559|NCT02023268|B1|Baseline|T2762|T2762: 1 drop in each eye 3 to 6 times daily during 84 days
90560|NCT02023268|P2|Participant Flow|Vismed®|Vismed®: 1 drop in each eye 3 to 6 times daily during 84 days
90561|NCT02023268|P1|Participant Flow|T2762|T2762: 1 drop in each eye 3 to 6 times daily during 84 days
90562|NCT02023268|O2|Outcome|Vismed|Vismed : 1 drop in each eye 3 to 6 times daily during 84 days
90563|NCT02023268|O1|Outcome|T2762|T2762: drop in each eye 3 to 6 times daily during 84 days
90564|NCT02023268|E2|Reported Event|Vismed®|Vismed®: 1 drop in each eye 3 to 6 times daily during 84 days
90565|NCT02023268|E1|Reported Event|T2762|T2762: 1 drop in each eye 3 to 6 times daily during 84 days
90566|NCT02023151|B1|Baseline|Omalizumab|"Active~Omalizumab"
90567|NCT02023151|P1|Participant Flow|Omalizumab|"Active~Omalizumab"
90568|NCT02023151|O1|Outcome|Omalizumab|"Active~Omalizumab"
90569|NCT02023151|O1|Outcome|Omalizumab|"Active~Omalizumab"
90570|NCT02023151|E1|Reported Event|Omalizumab|"Active~Omalizumab"
90572|NCT02023125|B2|Baseline|Group 2: Alectinib Alone, Alectinib + Esomeprazole|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1. Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
90573|NCT02023125|B1|Baseline|Group 1 (Treatment Sequence AB or BA)|Participants in Group 1 were randomly assigned to a two period treatment sequence (AB or BA) in which they received a single, oral dose of 600 mg of alectinib per period separated by at least 10 days. Each participant received single, oral doses alectinib given under fasted conditions (Treatment A) or following the ingestion of a high fat, high calorie meal (Treatment B) as determined by their assigned sequence.
90574|NCT02023125|P3|Participant Flow|Group 2: Alectinib Alone, Alectinib + Esomeprazole|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1. Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
90575|NCT02023125|P2|Participant Flow|Group 1: Treatment B First, Then Treatment A|Treatment B (Fed Treatment): Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal. Treatment A (Fasted Treatment): Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered. Each period was separated by at least 10 days.
90576|NCT02023125|P1|Participant Flow|Group 1: Treatment A First, Then Treatment B|Treatment A (Fasted Treatment): Following an overnight fast of at least 10 hours, a single 600 milligrams (mg) oral dose of alectinib was administered. Treatment B (Fed Treatment): Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal. Each period was separated by at least 10 days.
90577|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
90578|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
90579|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
90580|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
90581|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
90582|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
90583|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
90584|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
90585|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Day 16): Participants started the standardized meal 30 minutes prior to administration of alectinib. Participants were to consume this meal in 30 minutes or less. A single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal. Period 2 (Days 11 to 20): From Days 11 to 15 esomeprazole 40 mg was administered orally once daily in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40-mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal.
90586|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
90663|NCT02023099|O2|Outcome|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
90587|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
90588|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
90589|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
90590|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
90591|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
90592|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
90593|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
90594|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
90595|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
90596|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
90597|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
90598|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
90599|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
90600|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
90601|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
90602|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
90603|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
90604|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
90605|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
90606|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
90664|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
90607|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
90608|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
90609|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
90610|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
90611|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
90612|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
90613|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
90614|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
90615|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
90616|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
90617|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
90618|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
90619|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
90620|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
90621|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
90622|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
90623|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
90624|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
90625|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
90626|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
90665|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
90627|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
90628|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
90629|NCT02023125|E5|Reported Event|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
90630|NCT02023125|E4|Reported Event|Group 2: Period 2 (Esomeprazole Alone)|Period 2: From Days 11 to 15 esomeprazole 40 mg was administered orally once daily in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast.
90631|NCT02023125|E3|Reported Event|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
90632|NCT02023125|E2|Reported Event|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
90633|NCT02023125|E1|Reported Event|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
90634|NCT02023112|B3|Baseline|Total|Total of all reporting groups
90635|NCT02023112|B2|Baseline|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
90636|NCT02023112|B1|Baseline|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
90637|NCT02023112|P2|Participant Flow|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
90638|NCT02023112|P1|Participant Flow|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based ribavirin (RBV; 400 to 1,000 mg/day, divided twice daily) for 12 weeks
90639|NCT02023112|O2|Outcome|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
90640|NCT02023112|O1|Outcome|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
90641|NCT02023112|O2|Outcome|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
90642|NCT02023112|O1|Outcome|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
90643|NCT02023112|O2|Outcome|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
90644|NCT02023112|O1|Outcome|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
90645|NCT02023112|O2|Outcome|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
90646|NCT02023112|O1|Outcome|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
90647|NCT02023112|O2|Outcome|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
90648|NCT02023112|O1|Outcome|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
90649|NCT02023112|O2|Outcome|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
90650|NCT02023112|O1|Outcome|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
90651|NCT02023112|E4|Reported Event|ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Cirrhotic)|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks in cirrhotic participants
90652|NCT02023112|E3|Reported Event|ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Cirrhotic)|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks in cirrhotic participants
90653|NCT02023112|E2|Reported Event|ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Non-cirrhotic)|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks in non-cirrhotic participants
90654|NCT02023112|E1|Reported Event|ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Non-cirrhotic)|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks in non-cirrhotic participants
90655|NCT02023099|B4|Baseline|Total|Total of all reporting groups
90656|NCT02023099|B3|Baseline|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
90657|NCT02023099|B2|Baseline|Substudy 1, Arm B: DB Placebo, Followed by OL 2-DAA|DB placebo QD for 12 weeks followed by OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
90658|NCT02023099|B1|Baseline|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
91057|NCT02020616|O5|Outcome|100 mg LY3053102|100 mg LY3053102 administered SC QW for 12 weeks
90666|NCT02023099|O2|Outcome|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
90667|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
90668|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
90669|NCT02023099|O2|Outcome|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
90670|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
90671|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
90672|NCT02023099|E4|Reported Event|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
90673|NCT02023099|E3|Reported Event|Substudy 1, Arm B: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
90674|NCT02023099|E2|Reported Event|Substudy 1, Arm B: DB Placebo|DB placebo QD for 12 weeks in participants without cirrhosis
90675|NCT02023099|E1|Reported Event|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2 direct-acting antiviral agents [2-DAA]) once daily (QD) for 12 weeks in participants without cirrhosis.
90676|NCT02022826|B1|Baseline|SmartPill Monitoring System|patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
90677|NCT02022826|P1|Participant Flow|SmartPill Monitoring System|patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
90678|NCT02022826|O1|Outcome|SmartPill Monitoring System|patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
90679|NCT02022826|O1|Outcome|SmartPill Monitoring System|patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
90680|NCT02022826|E1|Reported Event|SmartPill Monitoring System|patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
90681|NCT02022748|B3|Baseline|Total|Total of all reporting groups
90682|NCT02022748|B2|Baseline|HS Subjects|Healthy subjects
90683|NCT02022748|B1|Baseline|HD Subjects|Hemodialysis subjects
90684|NCT02022748|P3|Participant Flow|Treatment H|Healthy subjects: ticagrelor oral 90 mg on 1 day of treatment
90685|NCT02022748|P2|Participant Flow|Sequence 2 (BA)|Hemodialysis patients: subjects will receive treatment B (ticagrelor oral 90 mg just prior to dialysis session) in period 1 and treatment A (ticagrelor oral 90 mg 1 day following the dialysis session but 2 days before the next dialysis session) in period 2.
90686|NCT02022748|P1|Participant Flow|Sequence 1 (AB)|hemodialysis patients: subjects will receive treatment A (ticagrelor oral 90 mg 1 day following the dialysis session but 2 days before the next dialysis session) in period 1 and treatment B (ticagrelor oral 90 mg just prior to dialysis session) in period 2.
90687|NCT02022748|O3|Outcome|Treatment H|Healthy subjects (HS) with normal renal function (CrCL of ≥90 mL/min) received one oral 90 mg ticagrelor tablet
90688|NCT02022748|O2|Outcome|Treatment B|HD subjects were dosed with an oral 90 mg ticagrelor tablet just prior to dialysis session.
90689|NCT02022748|O1|Outcome|Treatment A|HD subjects were dosed with an oral 90 mg ticagrelor tablet 1 day following the dialysis session but 2 days before the next dialysis session;
90690|NCT02022748|O3|Outcome|Treatment H|Healthy subjects (HS) with normal renal function (CrCL of ≥90 mL/min) received one oral 90 mg ticagrelor tablet
90691|NCT02022748|O2|Outcome|Treatment B|HD subjects were dosed with an oral 90 mg ticagrelor tablet just prior to dialysis session.
90692|NCT02022748|O1|Outcome|Treatment A|HD subjects were dosed with an oral 90 mg ticagrelor tablet 1 day following the dialysis session but 2 days before the next dialysis session;
90693|NCT02022748|O3|Outcome|Treatment H|Healthy subjects (HS) with normal renal function (CrCL of ≥90 mL/min) received one oral 90 mg ticagrelor tablet
90694|NCT02022748|O2|Outcome|Treatment B|HD subjects were dosed with an oral 90 mg ticagrelor tablet just prior to dialysis session.
90695|NCT02022748|O1|Outcome|Treatment A|HD subjects were dosed with an oral 90 mg ticagrelor tablet 1 day following the dialysis session but 2 days before the next dialysis session;
90696|NCT02022748|O3|Outcome|Treatment H|Healthy subjects (HS) with normal renal function (CrCL of ≥90 mL/min) received one oral 90 mg ticagrelor tablet
90697|NCT02022748|O2|Outcome|Treatment B|HD subjects were dosed with an oral 90 mg ticagrelor tablet just prior to dialysis session.
90698|NCT02022748|O1|Outcome|Treatment A|HD subjects were dosed with an oral 90 mg ticagrelor tablet 1 day following the dialysis session but 2 days before the next dialysis session;
90699|NCT02022748|O3|Outcome|Treatment H|Healthy subjects (HS) with normal renal function (CrCL of ≥90 mL/min) received one oral 90 mg ticagrelor tablet
90700|NCT02022748|O2|Outcome|Treatment B|HD subjects were dosed with an oral 90 mg ticagrelor tablet just prior to dialysis session.
90701|NCT02022748|O1|Outcome|Treatment A|HD subjects were dosed with an oral 90 mg ticagrelor tablet 1 day following the dialysis session but 2 days before the next dialysis session;
90702|NCT02022748|O3|Outcome|Treatment H|Healthy subjects (HS) with normal renal function (CrCL of ≥90 mL/min) received one oral 90 mg ticagrelor tablet
90703|NCT02022748|O2|Outcome|Treatment B|HD subjects were dosed with an oral 90 mg ticagrelor tablet just prior to dialysis session.
90704|NCT02022748|O1|Outcome|Treatment A|HD subjects were dosed with an oral 90 mg ticagrelor tablet 1 day following the dialysis session but 2 days before the next dialysis session;
90705|NCT02022748|E3|Reported Event|Treatment H|Healthy subjects (HS) with normal renal function (CrCL of ≥90 mL/min) received one oral 90 mg ticagrelor tablet
90706|NCT02022748|E2|Reported Event|Treatment B|HD subjects were dosed with an oral 90 mg ticagrelor tablet just prior to dialysis session.
90707|NCT02022748|E1|Reported Event|Treatment A|HD subjects were dosed with an oral 90 mg ticagrelor tablet 1 day following the dialysis session but 2 days before the next dialysis session;
90708|NCT02022670|B4|Baseline|Total|Total of all reporting groups
90709|NCT02022670|B3|Baseline|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
90710|NCT02022670|B2|Baseline|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
90711|NCT02022670|B1|Baseline|Placebo|Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
90712|NCT02022670|P3|Participant Flow|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
90713|NCT02022670|P2|Participant Flow|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
90714|NCT02022670|P1|Participant Flow|Placebo|Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
90715|NCT02022670|O3|Outcome|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
90716|NCT02022670|O2|Outcome|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
90717|NCT02022670|O1|Outcome|Placebo|"inert oral capsules (0 mg sodium nitrite morning; 0 mg sodium nitrite in evening) for 10 weeks~Placebo: Sugar pill manufactured to mimic sodium nitrite capsules"
90718|NCT02022670|O3|Outcome|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
90719|NCT02022670|O2|Outcome|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
90720|NCT02022670|O1|Outcome|Placebo|"inert oral capsules (0 mg sodium nitrite morning; 0 mg sodium nitrite in evening) for 10 weeks~Placebo: Sugar pill manufactured to mimic sodium nitrite capsules"
90721|NCT02022670|O3|Outcome|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
90722|NCT02022670|O2|Outcome|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
90723|NCT02022670|O1|Outcome|Placebo|Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
90724|NCT02022670|E3|Reported Event|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
90725|NCT02022670|E2|Reported Event|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
90726|NCT02022670|E1|Reported Event|Placebo|Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
90727|NCT02022085|B1|Baseline|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
90728|NCT02022085|P1|Participant Flow|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
90729|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
90730|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
90731|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
90822|NCT02021643|B3|Baseline|SOF+RBV 16 Weeks (GT1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
90732|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
90733|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
90734|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
90735|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
90736|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
90737|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
90738|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
90739|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
90740|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
90741|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
90742|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
90743|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
90744|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
90745|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
90746|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
90747|NCT02022085|E1|Reported Event|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
90748|NCT02022020|B1|Baseline|Dabigatran (Pradax® in Canada; Pradaxa® in the United States)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
90749|NCT02022020|P1|Participant Flow|Dabigatran (Pradax® in Canada; Pradaxa® in the United States)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
90750|NCT02022020|O1|Outcome|Dabigatran (Pradax® in Canada; Pradaxa® in the United States)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
90751|NCT02022020|O1|Outcome|Dabigatran (Pradax® in Canada; Pradaxa® in the United States)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
90823|NCT02021643|B2|Baseline|SOF+RBV 12 Weeks (GT1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
90752|NCT02022020|O1|Outcome|Dabigatran (Pradax® in Canada; Pradaxa® in the United States)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
90753|NCT02022020|E1|Reported Event|Dabigatran (Pradax® in Canada; Pradaxa® in the United States|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
90754|NCT02022007|B4|Baseline|Total|Total of all reporting groups
90755|NCT02022007|B3|Baseline|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)~5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks~Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks~Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
90756|NCT02022007|B2|Baseline|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks~Saxagliptin: Start 1 pill (5 mg)) for 3 weeks~Remain at 1 pill (5mg dose) for remainder of study"
90757|NCT02022007|B1|Baseline|Metformin XR|"Metformin 2000 mg QD for 16 weeks~Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks~Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
90758|NCT02022007|P3|Participant Flow|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)~5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks~Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks~Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
90759|NCT02022007|P2|Participant Flow|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks~Saxagliptin: Start 1 pill (5 mg)) for 3 weeks~Remain at 1 pill (5mg dose) for remainder of study"
90760|NCT02022007|P1|Participant Flow|Metformin XR|"Metformin 2000 mg QD for 16 weeks~Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks~Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
90761|NCT02022007|O3|Outcome|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)~5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks~Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks~Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
90762|NCT02022007|O2|Outcome|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks~Saxagliptin: Start 1 pill (5 mg)) for 3 weeks~Remain at 1 pill (5mg dose) for remainder of study"
90763|NCT02022007|O1|Outcome|Metformin XR|"Metformin 2000 mg QD for 16 weeks~Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks~Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
90764|NCT02022007|O3|Outcome|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)~5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks~Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks~Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
90765|NCT02022007|O2|Outcome|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks~Saxagliptin: Start 1 pill (5 mg)) for 3 weeks~Remain at 1 pill (5mg dose) for remainder of study"
90766|NCT02022007|O1|Outcome|Metformin XR|"Metformin 2000 mg QD for 16 weeks~Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks~Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
90767|NCT02022007|O3|Outcome|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)~5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks~Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks~Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
90768|NCT02022007|O2|Outcome|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks~Saxagliptin: Start 1 pill (5 mg)) for 3 weeks~Remain at 1 pill (5mg dose) for remainder of study"
90769|NCT02022007|O1|Outcome|Metformin XR|"Metformin 2000 mg QD for 16 weeks~Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks~Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
90770|NCT02022007|O3|Outcome|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)~5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks~Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks~Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
90771|NCT02022007|O2|Outcome|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks~Saxagliptin: Start 1 pill (5 mg)) for 3 weeks~Remain at 1 pill (5mg dose) for remainder of study"
90772|NCT02022007|O1|Outcome|Metformin XR|"Metformin 2000 mg QD for 16 weeks~Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks~Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
90773|NCT02022007|O3|Outcome|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)~5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks~Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks~Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
90774|NCT02022007|O2|Outcome|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks~Saxagliptin: Start 1 pill (5 mg)) for 3 weeks~Remain at 1 pill (5mg dose) for remainder of study"
90775|NCT02022007|O1|Outcome|Metformin XR|"Metformin 2000 mg QD for 16 weeks~Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks~Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
90776|NCT02022007|O3|Outcome|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)~5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks~Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks~Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
90777|NCT02022007|O2|Outcome|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks~Saxagliptin: Start 1 pill (5 mg)) for 3 weeks~Remain at 1 pill (5mg dose) for remainder of study"
90778|NCT02022007|O1|Outcome|Metformin XR|"Metformin 2000 mg QD for 16 weeks~Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks~Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
90779|NCT02022007|O3|Outcome|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)~5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks~Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks~Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
90780|NCT02022007|O2|Outcome|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks~Saxagliptin: Start 1 pill (5 mg)) for 3 weeks~Remain at 1 pill (5mg dose) for remainder of study"
90781|NCT02022007|O1|Outcome|Metformin XR|"Metformin 2000 mg QD for 16 weeks~Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks~Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
90782|NCT02022007|O3|Outcome|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)~5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks~Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks~Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
90783|NCT02022007|O2|Outcome|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks~Saxagliptin: Start 1 pill (5 mg)) for 3 weeks~Remain at 1 pill (5mg dose) for remainder of study"
90784|NCT02022007|O1|Outcome|Metformin XR|"Metformin 2000 mg QD for 16 weeks~Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks~Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
90785|NCT02022007|O3|Outcome|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)~5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks~Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks~Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
90786|NCT02022007|O2|Outcome|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks~Saxagliptin: Start 1 pill (5 mg)) for 3 weeks~Remain at 1 pill (5mg dose) for remainder of study"
90787|NCT02022007|O1|Outcome|Metformin XR|"Metformin 2000 mg QD for 16 weeks~Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks~Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
90788|NCT02022007|O3|Outcome|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)~5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks~Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks~Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
90789|NCT02022007|O2|Outcome|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks~Saxagliptin: Start 1 pill (5 mg)) for 3 weeks~Remain at 1 pill (5mg dose) for remainder of study"
90790|NCT02022007|O1|Outcome|Metformin XR|"Metformin 2000 mg QD for 16 weeks~Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks~Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
90791|NCT02022007|O3|Outcome|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)~5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks~Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks~Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
90792|NCT02022007|O2|Outcome|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks~Saxagliptin: Start 1 pill (5 mg)) for 3 weeks~Remain at 1 pill (5mg dose) for remainder of study"
90793|NCT02022007|O1|Outcome|Metformin XR|"Metformin 2000 mg QD for 16 weeks~Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks~Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
90794|NCT02022007|O3|Outcome|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)~5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks~Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks~Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
90795|NCT02022007|O2|Outcome|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks~Saxagliptin: Start 1 pill (5 mg)) for 3 weeks~Remain at 1 pill (5mg dose) for remainder of study"
90796|NCT02022007|O1|Outcome|Metformin XR|"Metformin 2000 mg QD for 16 weeks~Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks~Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
90797|NCT02022007|E3|Reported Event|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)~5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks~Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks~Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
90798|NCT02022007|E2|Reported Event|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks~Saxagliptin: Start 1 pill (5 mg)) for 3 weeks~Remain at 1 pill (5mg dose) for remainder of study"
90799|NCT02022007|E1|Reported Event|Metformin XR|"Metformin 2000 mg QD for 16 weeks~Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks~Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
90800|NCT02021942|B1|Baseline|SOM230 LAR|SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
90801|NCT02021942|P1|Participant Flow|SOM230 LAR|SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
90802|NCT02021942|O1|Outcome|SOM230 LAR|SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
90803|NCT02021942|O1|Outcome|SOM230 LAR|SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
90804|NCT02021942|O1|Outcome|SOM230 LAR|SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
90805|NCT02021942|O1|Outcome|SOM230 LAR|SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
90806|NCT02021942|O1|Outcome|SOM230 LAR|SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
90807|NCT02021942|O1|Outcome|SOM230 LAR|SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
90808|NCT02021942|O1|Outcome|SOM230 LAR|SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
90809|NCT02021942|E1|Reported Event|SOM230 LAR|SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
90810|NCT02021812|B1|Baseline|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis~Branched TAG® Device"
90811|NCT02021812|P1|Participant Flow|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis~Branched TAG® Device"
90812|NCT02021812|O1|Outcome|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis~Branched TAG® Device"
90813|NCT02021812|O1|Outcome|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis~Branched TAG® Device"
90814|NCT02021812|O1|Outcome|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis~Branched TAG® Device"
90815|NCT02021812|O1|Outcome|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis~Branched TAG® Device"
90816|NCT02021812|O1|Outcome|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis~Branched TAG® Device"
90817|NCT02021812|E1|Reported Event|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis~Branched TAG® Device"
90818|NCT02021643|B7|Baseline|Total|Total of all reporting groups
90819|NCT02021643|B6|Baseline|SOF+RBV 24 Weeks (GT3)|Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
90820|NCT02021643|B5|Baseline|SOF+RBV 12 Weeks (GT2)|Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
90821|NCT02021643|B4|Baseline|SOF+RBV 24 Weeks (GT1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
90824|NCT02021643|B1|Baseline|SOF+PEG+RBV 12 Weeks (GT 1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
90825|NCT02021643|P4|Participant Flow|SOF+RBV 24 Weeks|Participants with genotype 1, 3 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
90826|NCT02021643|P3|Participant Flow|SOF+RBV 16 Weeks|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
90827|NCT02021643|P2|Participant Flow|SOF+RBV 12 Weeks|Participants with genotype 1, 2 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
90828|NCT02021643|P1|Participant Flow|SOF+PEG+RBV 12 Weeks|Participants with genotype 1 or 6 received Sofosbuvir (Sovaldi®; SOF) 400 mg tablet once daily + Pegylated interferon alfa-2a (PEG) 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
90829|NCT02021643|O6|Outcome|SOF+RBV 24 Weeks (GT3)|Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
90830|NCT02021643|O5|Outcome|SOF+RBV 12 Weeks (GT2)|Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
90831|NCT02021643|O4|Outcome|SOF+RBV 24 Weeks (GT1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
90832|NCT02021643|O3|Outcome|SOF+RBV 16 Weeks (GT1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
90833|NCT02021643|O2|Outcome|SOF+RBV 12 Weeks (GT1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
90834|NCT02021643|O1|Outcome|SOF+PEG+RBV 12 Weeks (GT 1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
90835|NCT02021643|O6|Outcome|SOF+RBV 24 Weeks (GT3)|Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
90836|NCT02021643|O5|Outcome|SOF+RBV 12 Weeks (GT2)|Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
90837|NCT02021643|O4|Outcome|SOF+RBV 24 Weeks (GT1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
90838|NCT02021643|O3|Outcome|SOF+RBV 16 Weeks (GT1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
90839|NCT02021643|O2|Outcome|SOF+RBV 12 Weeks (GT1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
90840|NCT02021643|O1|Outcome|SOF+PEG+RBV 12 Weeks (GT 1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
90841|NCT02021643|O6|Outcome|SOF+RBV 24 Weeks (GT3)|Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
90842|NCT02021643|O5|Outcome|SOF+RBV 12 Weeks (GT2)|Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
90843|NCT02021643|O4|Outcome|SOF+RBV 24 Weeks (GT1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
90844|NCT02021643|O3|Outcome|SOF+RBV 16 Weeks (GT1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
90845|NCT02021643|O2|Outcome|SOF+RBV 12 Weeks (GT1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
90846|NCT02021643|O1|Outcome|SOF+PEG+RBV 12 Weeks (GT 1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
90847|NCT02021643|O6|Outcome|SOF+RBV 24 Weeks (GT3)|Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
90848|NCT02021643|O5|Outcome|SOF+RBV 12 Weeks (GT2)|Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
90849|NCT02021643|O4|Outcome|SOF+RBV 24 Weeks (GT1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
90850|NCT02021643|O3|Outcome|SOF+RBV 16 Weeks (GT1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
90851|NCT02021643|O2|Outcome|SOF+RBV 12 Weeks (GT1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
90852|NCT02021643|O1|Outcome|SOF+PEG+RBV 12 Weeks (GT 1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
90853|NCT02021643|O4|Outcome|SOF+RBV 24 Weeks|Participants with genotype 1, 3 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
90854|NCT02021643|O3|Outcome|SOF+RBV 16 Weeks|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
90855|NCT02021643|O2|Outcome|SOF+RBV 12 Weeks|Participants with genotype 1, 2 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
90906|NCT02021292|O2|Outcome|Placebo|Matching placebo oral tablet, to be taken once daily.
90907|NCT02021292|O1|Outcome|Macitentan|Macitentan 10 mg, oral tablet, to be taken once daily.
90856|NCT02021643|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants with genotype (GT) 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
90857|NCT02021643|O6|Outcome|SOF+RBV 24 Weeks (GT3)|Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
90858|NCT02021643|O5|Outcome|SOF+RBV 12 Weeks (GT2)|Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
90859|NCT02021643|O4|Outcome|SOF+RBV 24 Weeks (GT1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
90860|NCT02021643|O3|Outcome|SOF+RBV 16 Weeks (GT1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
90861|NCT02021643|O2|Outcome|SOF+RBV 12 Weeks (GT1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
90862|NCT02021643|O1|Outcome|SOF+PEG+RBV 12 Weeks (GT 1 and GT6)|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
90863|NCT02021643|E4|Reported Event|SOF+RBV 24 Weeks|Participants with genotype 1, 3 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
90864|NCT02021643|E3|Reported Event|SOF+RBV 16 Weeks|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
90865|NCT02021643|E2|Reported Event|SOF+RBV 12 Weeks|Participants with genotype 1, 2 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
90866|NCT02021643|E1|Reported Event|SOF+PEG+RBV 12 Weeks|Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
90867|NCT02021565|B3|Baseline|Total|Total of all reporting groups
90868|NCT02021565|B2|Baseline|Delayed Intervention Control Group|"Receives the in-home training intervention six weeks after completing the initial baseline assessment. This allows for a control comparison group while still providing the intervention to all participants.~In-home Training and Provision of Assistive Technology (prn): Assistive Technology Specialists (ATSs), experts on assistive technology devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform four activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, ATSs also recommend assistive technology equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, ATSs provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods."
90869|NCT02021565|B1|Baseline|Immediate Intervention Group|"Receives the in-home training intervention immediately after completing the baseline assessment.~In-home Training and Provision of Assistive Technology (prn): Assistive Technology Specialists (ATSs), experts on assistive technology devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform four activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, ATSs also recommend assistive technology equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, ATSs provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods."
90870|NCT02021565|P2|Participant Flow|Delayed Intervention Control Group|"Receives the in-home training intervention in-person six weeks after completing the initial baseline assessment. This allows for a control comparison group while still providing the intervention to all participants.~In-home Training and Provision of Assistive Technology (AT) (prn): AT Specialists, experts on AT devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform three activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, AT Specialists also recommend AT equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, AT Specialists provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods."
90871|NCT02021565|P1|Participant Flow|Immediate Intervention Group|"Receives the in-home training intervention in-person immediately after completing the baseline assessment.~In-home Training and Provision of Assistive Technology (prn): Assistive Technology (AT) Specialists, experts on AT devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform three activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, AT Specialists also recommend AT equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, AT Specialists provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods."
90872|NCT02021565|O2|Outcome|Delayed Intervention Control Group|"Control group.~Receives the in-home training intervention six weeks after completing the initial baseline assessment. This allows for a control comparison group while still providing the intervention to all participants.~In-home Training and Provision of Assistive Technology (prn): Assistive Technology Specialists (ATSs), experts on assistive technology devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform four activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, ATSs also recommend assistive technology equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, ATSs provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods."
90908|NCT02021292|O2|Outcome|Placebo|Matching placebo oral tablet, to be taken once daily.
90873|NCT02021565|O1|Outcome|Immediate Intervention Group|"Receives the in-home training intervention immediately after completing the baseline assessment.~In-home Training and Provision of Assistive Technology (prn): Assistive Technology Specialists (ATSs), experts on assistive technology devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform four activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, ATSs also recommend assistive technology equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, ATSs provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods."
90874|NCT02021565|O2|Outcome|Delayed Intervention Control Group|"Control group.~Receives the in-home training intervention six weeks after completing the initial baseline assessment. This allows for a control comparison group while still providing the intervention to all participants.~In-home Training and Provision of Assistive Technology (prn): Assistive Technology Specialists (ATSs), experts on assistive technology devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform four activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, ATSs also recommend assistive technology equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, ATSs provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods."
90875|NCT02021565|O1|Outcome|Immediate Intervention Group|"Receives the in-home training intervention immediately after completing the baseline assessment.~In-home Training and Provision of Assistive Technology (prn): Assistive Technology Specialists (ATSs), experts on assistive technology devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform four activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, ATSs also recommend assistive technology equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, ATSs provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods."
90876|NCT02021565|O2|Outcome|Delayed Intervention Control Group|"Control group.~Receives the in-home training intervention six weeks after completing the initial baseline assessment. This allows for a control comparison group while still providing the intervention to all participants.~In-home Training and Provision of Assistive Technology (prn): Assistive Technology Specialists (ATSs), experts on assistive technology devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform four activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, ATSs also recommend assistive technology equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, ATSs provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods."
90877|NCT02021565|O1|Outcome|Immediate Intervention Group|"Receives the in-home training intervention immediately after completing the baseline assessment.~In-home Training and Provision of Assistive Technology (prn): Assistive Technology Specialists (ATSs), experts on assistive technology devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform four activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, ATSs also recommend assistive technology equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, ATSs provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods."
90878|NCT02021565|E4|Reported Event|Delayed Intervention Control Group - Tele Arm|"Receives the in-home training intervention remotely via a tele-video conference six weeks after completing the initial baseline assessment. This allows for a control comparison group while still providing the intervention to all participants.~In-home Training and Provision of Assistive Technology (AT) (prn): AT Specialists, experts on AT devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform three activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, AT Specialists also recommend AT equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, AT Specialists provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods."
90879|NCT02021565|E3|Reported Event|Immediate Intervention Group - Tele Arm|"Receives the in-home training intervention remotely via a tele-video conference immediately after completing the baseline assessment.~In-home Training and Provision of Assistive Technology (AT) (prn): AT Specialists, experts on AT devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform three activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, AT Specialists also recommend AT equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, AT Specialists provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods."
90909|NCT02021292|O1|Outcome|Macitentan|Macitentan 10 mg, oral tablet, to be taken once daily.
90910|NCT02021292|O2|Outcome|Placebo|Matching placebo oral tablet, to be taken once daily.
90911|NCT02021292|O1|Outcome|Macitentan|Macitentan 10 mg, oral tablet, to be taken once daily.
90912|NCT02021292|O2|Outcome|Placebo|Matching placebo oral tablet, to be taken once daily
90913|NCT02021292|O1|Outcome|Macitentan|Macitentan 10 mg, oral tablet, to be taken once daily
90914|NCT02021292|E2|Reported Event|Placebo|Matching placebo oral tablet, to be taken once daily.
90915|NCT02021292|E1|Reported Event|Macitentan|Macitentan 10 mg, oral tablet, to be taken once daily.
90916|NCT02021071|B3|Baseline|Total|Total of all reporting groups
90880|NCT02021565|E2|Reported Event|Delayed Intervention Control Group - In-person|"Receives the in-home training intervention in-person six weeks after completing the initial baseline assessment. This allows for a control comparison group while still providing the intervention to all participants.~In-home Training and Provision of Assistive Technology (AT) (prn): AT Specialists, experts on AT devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform three activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, AT Specialists also recommend AT equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, AT Specialists provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods."
90881|NCT02021565|E1|Reported Event|Immediate Intervention Group - In-person|"Receives the in-home training intervention in-person immediately after completing the baseline assessment.~In-home Training and Provision of Assistive Technology (AT) (prn): AT Specialists, experts on AT devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform three activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, AT Specialists also recommend AT equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, AT Specialists provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods."
90882|NCT02021461|B1|Baseline|Eslicarbazepine Acetate|Eslicarbazepine acetate (ESL) was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
90883|NCT02021461|P1|Participant Flow|Eslicarbazepine Acetate|Eslicarbazepine acetate (ESL) was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
90884|NCT02021461|O3|Outcome|ESL Tutti-Frutti Taste|"ESL was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.~ESL Tutti-Frutti taste"
90885|NCT02021461|O2|Outcome|ESL Grape Taste|"ESL was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.~ESL Grape taste"
90886|NCT02021461|O1|Outcome|ESL Banana Taste|"ESL was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.~ESL Banana taste"
90887|NCT02021461|E1|Reported Event|Eslicarbazepine Acetate|Eslicarbazepine acetate (ESL) supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
90888|NCT02021331|B3|Baseline|Total|Total of all reporting groups
90889|NCT02021331|B2|Baseline|Immediate Implant Placement With Immediate Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.~immediate implant placement with immediate provisionalization"
90890|NCT02021331|B1|Baseline|Immediate Implant Placement Without Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.~immediate implant placement without provisionalization"
90891|NCT02021331|P2|Participant Flow|Immediate Implant Placement With Immediate Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.~immediate implant placement with immediate provisionalization"
90892|NCT02021331|P1|Participant Flow|Immediate Implant Placement Without Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.~immediate implant placement without provisionalization"
90893|NCT02021331|O2|Outcome|Immediate Implant Placement With Immediate Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.~immediate implant placement with immediate provisionalization"
90894|NCT02021331|O1|Outcome|Immediate Implant Placement Without Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.~immediate implant placement without provisionalization"
90895|NCT02021331|O2|Outcome|Immediate Implant Placement With Immediate Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.~immediate implant placement with immediate provisionalization"
90896|NCT02021331|O1|Outcome|Immediate Implant Placement Without Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.~immediate implant placement without provisionalization"
90897|NCT02021331|O2|Outcome|Immediate Implant Placement With Immediate Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.~immediate implant placement with immediate provisionalization"
90898|NCT02021331|O1|Outcome|Immediate Implant Placement Without Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.~immediate implant placement without provisionalization"
90899|NCT02021331|E2|Reported Event|Immediate Implant Placement With Immediate Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.~immediate implant placement with immediate provisionalization"
90900|NCT02021331|E1|Reported Event|Immediate Implant Placement Without Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.~immediate implant placement without provisionalization"
90901|NCT02021292|B3|Baseline|Total|Total of all reporting groups
90902|NCT02021292|B2|Baseline|Placebo|Matching placebo oral tablet, to be taken once daily.
90903|NCT02021292|B1|Baseline|Macitentan|Macitentan 10 mg, oral tablet, to be taken once daily.
90904|NCT02021292|P2|Participant Flow|Placebo|Matching placebo oral tablet, to be taken once daily.
90905|NCT02021292|P1|Participant Flow|Macitentan|Macitentan 10 mg, oral tablet, to be taken once daily.
90917|NCT02021071|B2|Baseline|XperGuide With Virtual Path Planning|"Image-guided needle procedures with XperGuide with virtual path planning~XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff."
90918|NCT02021071|B1|Baseline|XperGuide|"Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data)~XperGuide: Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT."
90919|NCT02021071|P2|Participant Flow|XperGuide With Virtual Path Planning|"Image-guided needle procedures with XperGuide with virtual path planning~XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff."
90920|NCT02021071|P1|Participant Flow|XperGuide|"Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data).~XperGuide: Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT."
90921|NCT02021071|O2|Outcome|XperGuide With Virtual Path Planning|"Image-guided needle procedures with XperGuide with virtual path planning~XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff."
90922|NCT02021071|O1|Outcome|XperGuide|"Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data)~XperGuide: Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT."
90923|NCT02021071|O1|Outcome|XperGuide With Virtual Path Planning|"Image-guided needle procedures with XperGuide with virtual path planning~XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff."
90924|NCT02021071|E2|Reported Event|XperGuide With Virtual Path Planning|"Image-guided needle procedures with XperGuide with virtual path planning~XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff."
90925|NCT02021071|E1|Reported Event|XperGuide|"Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data).~XperGuide: Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT."
90926|NCT02020941|B1|Baseline|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
90927|NCT02020941|P1|Participant Flow|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
90928|NCT02020941|O1|Outcome|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
90929|NCT02020941|O1|Outcome|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
90930|NCT02020941|O1|Outcome|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
90958|NCT02020889|O2|Outcome|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90959|NCT02020889|O1|Outcome|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90960|NCT02020889|O2|Outcome|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90931|NCT02020941|O1|Outcome|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
90932|NCT02020941|O1|Outcome|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
90933|NCT02020941|O1|Outcome|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
90934|NCT02020941|E1|Reported Event|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
90935|NCT02020889|B3|Baseline|Total|Total of all reporting groups
90936|NCT02020889|B2|Baseline|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90937|NCT02020889|B1|Baseline|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90938|NCT02020889|P2|Participant Flow|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90939|NCT02020889|P1|Participant Flow|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90940|NCT02020889|O2|Outcome|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90941|NCT02020889|O1|Outcome|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90942|NCT02020889|O2|Outcome|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90943|NCT02020889|O1|Outcome|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90944|NCT02020889|O2|Outcome|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90945|NCT02020889|O1|Outcome|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90946|NCT02020889|O2|Outcome|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90947|NCT02020889|O1|Outcome|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90948|NCT02020889|O2|Outcome|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90949|NCT02020889|O1|Outcome|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90950|NCT02020889|O2|Outcome|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90951|NCT02020889|O1|Outcome|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90952|NCT02020889|O2|Outcome|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90953|NCT02020889|O1|Outcome|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90954|NCT02020889|O2|Outcome|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90955|NCT02020889|O1|Outcome|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90956|NCT02020889|O2|Outcome|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90957|NCT02020889|O1|Outcome|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
91050|NCT02020616|O5|Outcome|100 mg LY3053102|100 mg LY3053102 administered SC QW for 12 weeks
90961|NCT02020889|O1|Outcome|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90962|NCT02020889|O2|Outcome|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90963|NCT02020889|O1|Outcome|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90964|NCT02020889|O2|Outcome|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90965|NCT02020889|O1|Outcome|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90966|NCT02020889|O2|Outcome|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90967|NCT02020889|O1|Outcome|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90968|NCT02020889|O2|Outcome|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90969|NCT02020889|O1|Outcome|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90970|NCT02020889|O2|Outcome|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90971|NCT02020889|O1|Outcome|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90972|NCT02020889|O2|Outcome|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90973|NCT02020889|O1|Outcome|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90974|NCT02020889|O2|Outcome|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90975|NCT02020889|O1|Outcome|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90976|NCT02020889|O2|Outcome|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90977|NCT02020889|O1|Outcome|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90978|NCT02020889|O2|Outcome|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90979|NCT02020889|O1|Outcome|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90980|NCT02020889|O2|Outcome|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90981|NCT02020889|O1|Outcome|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90982|NCT02020889|O2|Outcome|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90983|NCT02020889|O1|Outcome|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90984|NCT02020889|O2|Outcome|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90985|NCT02020889|O1|Outcome|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90986|NCT02020889|O2|Outcome|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90987|NCT02020889|O1|Outcome|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90988|NCT02020889|O2|Outcome|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90989|NCT02020889|O1|Outcome|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90990|NCT02020889|E2|Reported Event|Mepolizumab 300mg|Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
90991|NCT02020889|E1|Reported Event|Placebo|Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
90992|NCT02020863|B1|Baseline|Closed Loop|"Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration.~Closed Loop: Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors."
90993|NCT02020863|P1|Participant Flow|Closed Loop|"Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration.~Closed Loop: Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors."
91051|NCT02020616|O4|Outcome|50 mg LY3053102|50 mg LY3053102 administered SC QW for 12 weeks
91052|NCT02020616|O3|Outcome|15 mg LY3053102|15 mg LY3053102 administered SC QW for 12 weeks
91053|NCT02020616|O2|Outcome|7 mg LY3053102|7 mg LY3053102 administered SC QW for 12 weeks
90994|NCT02020863|O1|Outcome|Closed Loop|"Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration.~Closed Loop: Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors."
90995|NCT02020863|E1|Reported Event|Closed Loop|"Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration.~Closed Loop: Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors."
90996|NCT02020837|B1|Baseline|Lymphaticovenous Micro-Anastomosis|Lymphaticovenous Micro-Anastomosis
90997|NCT02020837|P1|Participant Flow|Lymphaticovenous Micro-Anastomosis|Lymphaticovenous Micro-Anastomosis
90998|NCT02020837|O1|Outcome|Lymphaticovenous Micro-Anastomosis|Lymphaticovenous Micro-Anastomosis
90999|NCT02020837|E1|Reported Event|Lymphaticovenous Micro-Anastomosis|Lymphaticovenous Micro-Anastomosis
91000|NCT02020616|B8|Baseline|Total|Total of all reporting groups
91001|NCT02020616|B7|Baseline|2 mg Exenatide ER|2 mg Exenatide ER administered SC QW for 12 weeks
91002|NCT02020616|B6|Baseline|200 mg LY3053102|200 mg LY3053102 administered SC QW for 12 weeks
91003|NCT02020616|B5|Baseline|100 mg LY3053102|100 mg LY3053102 administered SC QW for 12 weeks
91004|NCT02020616|B4|Baseline|50 mg LY3053102|50 mg LY3053102 administered SC QW for 12 weeks
91005|NCT02020616|B3|Baseline|15 mg LY3053102|15 mg LY3053102 administered SC QW for 12 weeks
91006|NCT02020616|B2|Baseline|7 mg LY3053102|7 mg LY3053102 administered SC QW for 12 weeks
91007|NCT02020616|B1|Baseline|Placebo|Placebo administered SC QW for 12 weeks
91008|NCT02020616|P7|Participant Flow|2 mg Exenatide ER|2 mg exenatide ER administered SC Q1W for 12 weeks.
91009|NCT02020616|P6|Participant Flow|200 mg LY3053102|200 mg LY3053102 administered SC Q1W for 12 weeks.
91010|NCT02020616|P5|Participant Flow|100 mg LY3053102|100 mg LY3053102 administered SC Q1W for 12 weeks.
91011|NCT02020616|P4|Participant Flow|50 mg LY3053102|50 mg LY3053102 administered SC Q1W for 12 weeks.
91012|NCT02020616|P3|Participant Flow|15 mg LY3053102|15 mg LY3053102 administered SC Q1W for 12 weeks.
91013|NCT02020616|P2|Participant Flow|7 mg LY3053102|7 mg LY3053102 administered SC Q1W for 12 weeks.
91014|NCT02020616|P1|Participant Flow|Placebo|Placebo administered by subcutaneous injection (SC) once a week (Q1W) for 12 weeks
91015|NCT02020616|O5|Outcome|200 mg LY3053102|200 mg LY3053102 administered SC QW for 12 weeks
91016|NCT02020616|O4|Outcome|100 mg LY3053102|100 mg LY3053102 administered SC QW for 12 weeks
91017|NCT02020616|O3|Outcome|50 mg LY3053102|50 mg LY3053102 administered SC QW for 12 weeks
91018|NCT02020616|O2|Outcome|15 mg LY3053102|15 mg LY3053102 administered SC QW for 12 weeks
91019|NCT02020616|O1|Outcome|7 mg LY3053102|7 mg LY3053102 administered SC QW for 12 weeks
91020|NCT02020616|O7|Outcome|2 mg Exenatide ER|2 mg exenatide ER administered SC QW for 12 weeks
91021|NCT02020616|O6|Outcome|200 mg LY3053102|200 mg LY3053102 administered SC QW for 12 weeks
91022|NCT02020616|O5|Outcome|100 mg LY3053102|100 mg LY3053102 administered SC QW for 12 weeks
91023|NCT02020616|O4|Outcome|50 mg LY3053102|50 mg LY3053102 administered SC QW for 12 weeks
91024|NCT02020616|O3|Outcome|15 mg LY3053102|15 mg LY3053102 administered SC QW for 12 weeks
91025|NCT02020616|O2|Outcome|7 mg LY3053102|7 mg LY3053102 administered SC QW for 12 weeks
91026|NCT02020616|O1|Outcome|Placebo|Placebo administered SC QW for 12 weeks
91027|NCT02020616|O7|Outcome|2 mg Exenatide ER|2 mg exenatide ER administered SC QW for 12 weeks
91028|NCT02020616|O6|Outcome|200 mg LY3053102|200 mg LY3053102 administered SC QW for 12 weeks
91029|NCT02020616|O5|Outcome|100 mg LY3053102|100 mg LY3053102 administered SC QW for 12 weeks
91030|NCT02020616|O4|Outcome|50 mg LY3053102|50 mg LY3053102 administered SC QW for 12 weeks
91031|NCT02020616|O3|Outcome|15 mg LY3053102|15 mg LY3053102 administered SC QW for 12 weeks
91032|NCT02020616|O2|Outcome|7 mg LY3053102|7 mg LY3053102 administered SC QW for 12 weeks
91033|NCT02020616|O1|Outcome|Placebo|Placebo administered SC QW for 12 weeks
91034|NCT02020616|O7|Outcome|2 mg Exenatide ER|2 mg exenatide ER administered SC QW for 12 weeks
91035|NCT02020616|O6|Outcome|200 mg LY3053102|200 mg LY3053102 administered SC QW for 12 weeks
91036|NCT02020616|O5|Outcome|100 mg LY3053102|100 mg LY3053102 administered SC QW for 12 weeks
91037|NCT02020616|O4|Outcome|50 mg LY3053102|50 mg LY3053102 administered SC QW for 12 weeks
91038|NCT02020616|O3|Outcome|15 mg LY3053102|15 mg LY3053102 administered SC QW for 12 weeks
91039|NCT02020616|O2|Outcome|7 mg LY3053102|7 mg LY3053102 administered SC QW for 12 weeks
91040|NCT02020616|O1|Outcome|Placebo|Placebo administered SC QW for 12 weeks
91041|NCT02020616|O7|Outcome|2 mg Exenatide ER|2 mg exenatide ER administered SC QW for 12 weeks
91042|NCT02020616|O6|Outcome|200 mg LY3053102|200 mg LY3053102 administered SC QW for 12 weeks
91043|NCT02020616|O5|Outcome|100 mg LY3053102|100 mg LY3053102 administered SC QW for 12 weeks
91044|NCT02020616|O4|Outcome|50 mg LY3053102|50 mg LY3053102 administered SC QW for 12 weeks
91045|NCT02020616|O3|Outcome|15 mg LY3053102|15 mg LY3053102 administered SC QW for 12 weeks
91046|NCT02020616|O2|Outcome|7 mg LY3053102|7 mg LY3053102 administered SC QW for 12 weeks
91047|NCT02020616|O1|Outcome|Placebo|Placebo administered SC QW for 12 weeks
91048|NCT02020616|O7|Outcome|2 mg Exenatide ER|2 mg exenatide ER administered SC QW for 12 weeks
91049|NCT02020616|O6|Outcome|200 mg LY3053102|200 mg LY3053102 administered SC QW for 12 weeks
91058|NCT02020616|O4|Outcome|50 mg LY3053102|50 mg LY3053102 administered SC QW for 12 weeks
91059|NCT02020616|O3|Outcome|15 mg LY3053102|15 mg LY3053102 administered SC QW for 12 weeks
91060|NCT02020616|O2|Outcome|7 mg LY3053102|7 mg LY3053102 administered SC QW for 12 weeks
91061|NCT02020616|O1|Outcome|Placebo|Placebo administered SC QW for 12 weeks
91062|NCT02020616|O7|Outcome|2 mg Exenatide ER|2 mg exenatide ER administered SC QW for 12 weeks
91063|NCT02020616|O6|Outcome|200 mg LY3053102|200 mg LY3053102 administered SC QW for 12 weeks
91064|NCT02020616|O5|Outcome|100 mg LY3053102|100 mg LY3053102 administered SC QW for 12 weeks
91065|NCT02020616|O4|Outcome|50 mg LY3053102|50 mg LY3053102 administered SC QW for 12 weeks
91066|NCT02020616|O3|Outcome|15 mg LY3053102|15 mg LY3053102 administered SC QW for 12 weeks
91067|NCT02020616|O2|Outcome|7 mg LY3053102|7 mg LY3053102 administered SC QW for 12 weeks
91068|NCT02020616|O1|Outcome|Placebo|Placebo administered SC QW for 12 weeks
91069|NCT02020616|O7|Outcome|2 mg Exenatide ER|2 mg exenatide ER administered SC Q1W for 12 weeks
91070|NCT02020616|O6|Outcome|200 mg LY3053102|200 mg LY3053102 administered SC Q1W for 12 weeks
91071|NCT02020616|O5|Outcome|100 mg LY3053102|100 mg LY3053102 administered SC Q1W for 12 weeks
91072|NCT02020616|O4|Outcome|50 mg LY3053102|50 mg LY3053102 50 mg administered SC Q1W for 12 weeks
91073|NCT02020616|O3|Outcome|15 mg LY3053102|15 mg LY3053102 administered SC Q1W for 12 weeks
91074|NCT02020616|O2|Outcome|7 mg LY3053102|7 mg LY3053102 administered SC Q1W for 12 weeks
91075|NCT02020616|O1|Outcome|Placebo|Placebo administered SC Q1W for 12 weeks
91076|NCT02020616|O7|Outcome|2 mg Exenatide ER|2 mg exenatide ER administered SC QW for 12 weeks
91077|NCT02020616|O6|Outcome|200 mg LY3053102|200 mg LY3053102 administered SC QW for 12 weeks
91078|NCT02020616|O5|Outcome|100 mg LY3053102|100 mg LY3053102 administered SC QW for 12 weeks
91079|NCT02020616|O4|Outcome|50 mg LY3053102|50 mg LY3053102 administered SC QW for 12 weeks
91080|NCT02020616|O3|Outcome|15 mg LY3053102|15 mg LY3053102 administered SC QW for 12 weeks
91081|NCT02020616|O2|Outcome|7 mg LY3053102|7 mg LY3053102 administered SC QW for 12 weeks
91082|NCT02020616|O1|Outcome|Placebo|Placebo administered SC QW for 12 weeks
91083|NCT02020616|O7|Outcome|2 mg Exenatide ER|2 mg exenatide ER administered SC QW for 12 weeks
91084|NCT02020616|O6|Outcome|200 mg LY3053102|200 mg LY3053102 administered SC QW for 12 weeks
91085|NCT02020616|O5|Outcome|100 mg LY3053102|100 mg LY3053102 administered SC QW for 12 weeks
91086|NCT02020616|O4|Outcome|50 mg LY3053102|50 mg LY3053102 administered SC QW for 12 weeks
91087|NCT02020616|O3|Outcome|15 mg LY3053102|15 mg LY3053102 administered SC QW for 12 weeks
91088|NCT02020616|O2|Outcome|7 mg LY3053102|7 mg LY3053102 administered SC QW for 12 weeks
91089|NCT02020616|O1|Outcome|Placebo|Placebo administered SC QW for 12 weeks
91090|NCT02020616|O7|Outcome|2 mg Exenatide ER|2 mg Exenatide ER administered SC Q1W for 12 weeks
91091|NCT02020616|O6|Outcome|200 mg LY3053102|200 mg LY3053102 administered SC Q1W for 12 weeks
91092|NCT02020616|O5|Outcome|100 mg LY3053102|100 mg LY3053102 administered SC Q1W for 12 weeks
91093|NCT02020616|O4|Outcome|50 mg LY3053102|50 mg LY3053102 administered SC Q1W for 12 weeks
91094|NCT02020616|O3|Outcome|15 mg LY3053102|15 mg LY3053102 administered SC Q1W for 12 weeks
91095|NCT02020616|O2|Outcome|7 mg LY3053102|7 mg LY3053102 administered SC Q1W for 12 weeks
91096|NCT02020616|O1|Outcome|Placebo|Placebo administered SC Q1W for 12 weeks
91097|NCT02020616|E7|Reported Event|2 mg Exenatide ER|2 mg exenatide ER administered SC QW for 12 weeks
91098|NCT02020616|E6|Reported Event|200 mg LY3053102|200 mg LY3053102 administered SC QW for 12 weeks
91099|NCT02020616|E5|Reported Event|100 mg LY3053102|100 mg LY3053102 administered SC QW for 12 weeks
91100|NCT02020616|E4|Reported Event|50 mg LY3053102|50 mg LY3053102 administered SC QW for 12 weeks
91101|NCT02020616|E3|Reported Event|15 mg LY3053102|15 mg LY3053102 administered SC QW for 12 weeks
91102|NCT02020616|E2|Reported Event|7 mg LY3053102|7 mg LY3053102 administered SC QW for 12 weeks
91103|NCT02020616|E1|Reported Event|Placebo|Placebo administered by SC QW for 12 weeks
91104|NCT02020577|B3|Baseline|Total|Total of all reporting groups
91105|NCT02020577|B2|Baseline|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
91106|NCT02020577|B1|Baseline|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
91107|NCT02020577|P2|Participant Flow|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
91108|NCT02020577|P1|Participant Flow|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
91109|NCT02020577|O2|Outcome|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
91110|NCT02020577|O1|Outcome|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
91111|NCT02020577|O3|Outcome|All Patients|Patients who were administered Afatinib 30mg+cetuximab 250 mg/m² plus the patients who were administered Afatinib 40mg+cetuximab 250 mg/m².
91112|NCT02020577|O2|Outcome|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
91113|NCT02020577|O1|Outcome|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
91114|NCT02020577|O3|Outcome|All Patients|Patients who were administered Afatinib 30mg+cetuximab 250 mg/m² plus the patients who were administered Afatinib 40mg+cetuximab 250 mg/m².
91115|NCT02020577|O2|Outcome|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
91116|NCT02020577|O1|Outcome|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
91117|NCT02020577|O3|Outcome|All Patients|Patients who were administered Afatinib 30mg+cetuximab 250 mg/m² plus the patients who were administered Afatinib 40mg+cetuximab 250 mg/m².
91118|NCT02020577|O2|Outcome|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
91119|NCT02020577|O1|Outcome|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
91120|NCT02020577|O2|Outcome|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
91121|NCT02020577|O1|Outcome|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
91122|NCT02020577|O3|Outcome|All Patients|Patients who were administered Afatinib 30mg+cetuximab 250 mg/m² plus the patients who were administered Afatinib 40mg+cetuximab 250 mg/m².
91123|NCT02020577|O2|Outcome|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
91124|NCT02020577|O1|Outcome|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
91125|NCT02020577|O2|Outcome|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
91126|NCT02020577|O1|Outcome|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
91127|NCT02020577|O2|Outcome|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
91128|NCT02020577|O1|Outcome|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
91129|NCT02020577|O2|Outcome|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
91130|NCT02020577|O1|Outcome|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
91131|NCT02020577|E3|Reported Event|All Patients|Patients who were administered Afatinib 30mg+cetuximab 250 mg/m² plus the patients who were administered Afatinib 40mg+cetuximab 250 mg/m².
91132|NCT02020577|E2|Reported Event|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
91133|NCT02020577|E1|Reported Event|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
91134|NCT02020512|B1|Baseline|0.03% Bimatoprost|0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
91135|NCT02020512|P1|Participant Flow|0.03% Bimatoprost|0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
91136|NCT02020512|O1|Outcome|0.03% Bimatoprost|0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
91137|NCT02020512|E1|Reported Event|0.03% Bimatoprost|0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
91138|NCT02020369|B3|Baseline|Total|Total of all reporting groups
91139|NCT02020369|B2|Baseline|FVIIa 225 µg/kg First, Then 75 µg/kg|Coagulation Factor VIIa (Recombinant): First Intervention (3 months), Second Intervention (3 months), continue cycle until end of study.
91140|NCT02020369|B1|Baseline|FVIIa 75 µg/kg First, Then 225 µg/kg|Coagulation Factor VIIa (Recombinant): First Intervention (3 months), Second Intervention (3 months), continue cycle until end of study.
91141|NCT02020369|P2|Participant Flow|FVIIa: 75 µg/kg First, Then 225 µg/kg|Coagulation Factor VIIa (Recombinant): Coagulation Factor VIIa (Recombinant) : First Intervention (3 months), Second Intervention (3 months), repeat sequence for entirety of study.
91142|NCT02020369|P1|Participant Flow|FVIIa: 225 µg/kg First, Then 75 µg/kg|Coagulation Factor VIIa (Recombinant) : First Intervention (3 months), Second Intervention (3 months), repeat sequence for entirety of study.
91143|NCT02020369|O2|Outcome|FVIIa: 225 µg/kg|225 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
91144|NCT02020369|O1|Outcome|FVIIa: 75 µg/kg|75 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
91145|NCT02020369|O2|Outcome|FVIIa: 225 µg/kg|225 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
91146|NCT02020369|O1|Outcome|Factor VIIa: 75 µg/kg|75 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
91147|NCT02020369|O2|Outcome|FVIIa: 225 µg/kg|225 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
91148|NCT02020369|O1|Outcome|FVIIa: 75 µg/kg|75 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
91149|NCT02020369|O2|Outcome|FVIIa: 225 µg/kg|225 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
91150|NCT02020369|O1|Outcome|FVIIa: 75 µg/kg|75 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
91151|NCT02020369|O2|Outcome|FVIIa 225µg/kg|225 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
91152|NCT02020369|O1|Outcome|FVIIa 75 µg/kg|75 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
91153|NCT02020369|E2|Reported Event|Coagulation Factor VIIa (Recombinant): 225 µg/kg|"Coagulation Factor VIIa (Recombinant) : 225 µg/kg for 3 months~Coagulation Factor VIIa (Recombinant): A cross over design to assess the efficacy of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII/IX"
91154|NCT02020369|E1|Reported Event|Coagulation Factor VIIa (Recombinant): 75 µg/kg|"Coagulation Factor VIIa (Recombinant): 75 µg/kg for 3 months~Coagulation Factor VIIa (Recombinant): A cross over design to assess the efficacy of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII/IX"
91155|NCT02020304|B3|Baseline|Total|Total of all reporting groups
91156|NCT02020304|B2|Baseline|Refrigerated Temperature|"refrigerated temperature combined spinal epidural dose (~<43 degrees F)~combined spinal epidural: Combined Spinal Epidural"
91157|NCT02020304|B1|Baseline|Room Temperature|"room temperature combined spinal epidural dose (60-75 degrees F)~combined spinal epidural: Combined Spinal Epidural"
91158|NCT02020304|P2|Participant Flow|Refrigerated Temperature|"refrigerated temperature combined spinal epidural dose (~<43 degrees F)~combined spinal epidural: Combined Spinal Epidural"
91159|NCT02020304|P1|Participant Flow|Room Temperature|"room temperature combined spinal epidural dose (60-75 degrees F)~combined spinal epidural: Combined Spinal Epidural"
91160|NCT02020304|O2|Outcome|Refrigerated Temperature|"refrigerated temperature combined spinal epidural dose (~<43 degrees F)~combined spinal epidural: Combined Spinal Epidural"
91161|NCT02020304|O1|Outcome|Room Temperature|"room temperature combined spinal epidural dose (60-75 degrees F)~combined spinal epidural: Combined Spinal Epidural"
91162|NCT02020304|O2|Outcome|Refrigerated Temperature|"refrigerated temperature combined spinal epidural dose (~<43 degrees F)~combined spinal epidural: Combined Spinal Epidural"
91163|NCT02020304|O1|Outcome|Room Temperature|"room temperature combined spinal epidural dose (60-75 degrees F)~combined spinal epidural: Combined Spinal Epidural"
91164|NCT02020304|O2|Outcome|Refrigerated Temperature|"refrigerated temperature combined spinal epidural dose (~<43 degrees F)~combined spinal epidural: Combined Spinal Epidural"
91165|NCT02020304|O1|Outcome|Room Temperature|"room temperature combined spinal epidural dose (60-75 degrees F)~combined spinal epidural: Combined Spinal Epidural"
91166|NCT02020304|O2|Outcome|Refrigerated Temperature|"refrigerated temperature combined spinal epidural dose (~<43 degrees F)~combined spinal epidural: Combined Spinal Epidural"
91167|NCT02020304|O1|Outcome|Room Temperature|"room temperature combined spinal epidural dose (60-75 degrees F)~combined spinal epidural: Combined Spinal Epidural"
91168|NCT02020304|O2|Outcome|Refrigerated Temperature|"refrigerated temperature combined spinal epidural dose (~<43 degrees F)~combined spinal epidural: Combined Spinal Epidural"
91169|NCT02020304|O1|Outcome|Room Temperature|"room temperature combined spinal epidural dose (60-75 degrees F)~combined spinal epidural: Combined Spinal Epidural"
91170|NCT02020304|E2|Reported Event|Refrigerated Temperature|"refrigerated temperature combined spinal epidural dose (~<43 degrees F)~combined spinal epidural: Combined Spinal Epidural"
91171|NCT02020304|E1|Reported Event|Room Temperature|"room temperature combined spinal epidural dose (60-75 degrees F)~combined spinal epidural: Combined Spinal Epidural"
91172|NCT02020135|B3|Baseline|Total|Total of all reporting groups
91173|NCT02020135|B2|Baseline|PSMA ADC Chemotherapy-naive|"Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.~PSMA ADC: Upon recommendation from the PI and after Sponsor approval, a subject benefitting from treatment could have received up to eight additional doses Q3W. Subjects were weighed prior to each cycle and dosing was calculated on a mg/kg basis prior to each dose, with a maximum weight of 100 kg for dosing calculations."
91189|NCT02020031|O2|Outcome|Vancomycin 1g IV|Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
91174|NCT02020135|B1|Baseline|PSMA ADC Chemotherapy-experienced|"Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.~PSMA ADC: Upon recommendation from the PI and after Sponsor approval, a subject benefitting from treatment could have received up to eight additional doses Q3W. Subjects were weighed prior to each cycle and dosing was calculated on a mg/kg basis prior to each dose, with a maximum weight of 100 kg for dosing calculations."
91175|NCT02020135|P1|Participant Flow|Arm 1: PSMA ADC|"Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.~PSMA ADC: Upon recommendation from the PI and after Sponsor approval, a subject benefitting from treatment could have received up to eight additional doses Q3W. Subjects were weighed prior to each cycle and dosing was calculated on a mg/kg basis prior to each dose, with a maximum weight of 100 kg for dosing calculations."
91176|NCT02020135|O2|Outcome|PSMA ADC Chemotherapy-naive|"The chemotherapy-naïve group was comprised of 3 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.~Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
91177|NCT02020135|O1|Outcome|PSMA ADC Chemotherapy-experienced|"The chemotherapy-experienced group was comprised of 6 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).~Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
91178|NCT02020135|O2|Outcome|PSMA ADC Chemotherapy-naive|"The chemotherapy-naïve group was comprised of 3 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.~Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
91179|NCT02020135|O1|Outcome|PSMA ADC Chemotherapy-experienced|"The chemotherapy-experienced group was comprised of 6 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).~Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
91180|NCT02020135|O2|Outcome|PSMA ADC Chemotherapy-naive|"The chemotherapy-naïve group was comprised of 3 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.~Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
91181|NCT02020135|O1|Outcome|PSMA ADC Chemotherapy-experienced|"The chemotherapy-experienced group was comprised of 6 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).~Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
91182|NCT02020135|E2|Reported Event|PSMA ADC Chemotherapy-naive|"The chemotherapy-naïve group was comprised of 3 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.~Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
91183|NCT02020135|E1|Reported Event|PSMA ADC Chemotherapy-experienced|"The chemotherapy-experienced group was comprised of 6 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).~Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
91184|NCT02020031|B3|Baseline|Total|Total of all reporting groups
91185|NCT02020031|B2|Baseline|Vancomycin 1g IV|Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
91186|NCT02020031|B1|Baseline|Vancomycin 500mg Intraosseous|Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
91187|NCT02020031|P2|Participant Flow|Vancomycin 1g IV|Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
91188|NCT02020031|P1|Participant Flow|Vancomycin 500mg Intraosseous|Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
91190|NCT02020031|O1|Outcome|Vancomycin 500mg Intraosseous|Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
91191|NCT02020031|O2|Outcome|Vancomycin 1g IV|Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
91192|NCT02020031|O1|Outcome|Vancomycin 500mg Intraosseous|Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
91193|NCT02020031|E2|Reported Event|Vancomycin 1g IV|Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
91194|NCT02020031|E1|Reported Event|Vancomycin 500mg Intraosseous|Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
91195|NCT02019979|B1|Baseline|Metformin /Carbohydrate Restricted Diet|"metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen~metformin: Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy~carbohydrate restricted diet: addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy"
91196|NCT02019979|P1|Participant Flow|Metformin /Carbohydrate Restricted Diet|"metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen~metformin: Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy~carbohydrate restricted diet: addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy"
91197|NCT02019979|O1|Outcome|Metformin /Carbohydrate Restricted Diet|"metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen~metformin: Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy~carbohydrate restricted diet: addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy"
91198|NCT02019979|O1|Outcome|Metformin /Carbohydrate Restricted Diet|"metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen~metformin: Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy~carbohydrate restricted diet: addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy"
91199|NCT02019979|O1|Outcome|Metformin /Carbohydrate Restricted Diet|"metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen~metformin: Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy~carbohydrate restricted diet: addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy"
91200|NCT02019979|E1|Reported Event|Metformin /Carbohydrate Restricted Diet|"metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen~metformin: Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy~carbohydrate restricted diet: addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy"
91201|NCT02019719|B6|Baseline|Total|Total of all reporting groups
91202|NCT02019719|B5|Baseline|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4 Week treatment period.
91203|NCT02019719|B4|Baseline|GSK1278863 8 mg|Eligible participant's received GSK1278863 8 mg once daily for the 4 Week treatment period.
91204|NCT02019719|B3|Baseline|GSK1278863 6 mg|Eligible participant's received GSK1278863 6 mg once daily for the 4 Week treatment period.
91205|NCT02019719|B2|Baseline|GSK1278863 4 mg|Eligible participant's received GSK1278863 4 mg once daily for the 4 Week treatment period.
91206|NCT02019719|B1|Baseline|Placebo|Eligible participant's received matching placebo to GSK1278863 once daily for the 4 Week treatment period.
91207|NCT02019719|P5|Participant Flow|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4 Week treatment period.
91208|NCT02019719|P4|Participant Flow|GSK1278863 8 mg|Eligible participant's received GSK1278863 8 mg once daily for the 4 Week treatment period.
91209|NCT02019719|P3|Participant Flow|GSK1278863 6 mg|Eligible participant's received GSK1278863 6 mg once daily for the 4 Week treatment period.
91210|NCT02019719|P2|Participant Flow|GSK1278863 4 mg|Eligible participant's received GSK1278863 4 milligrams (mg) once daily for the 4 Week treatment period.
91211|NCT02019719|P1|Participant Flow|Placebo|Eligible participant's received matching placebo to GSK1278863 once daily for the 4 Week treatment period.
91212|NCT02019719|O5|Outcome|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4 Week treatment period.
91213|NCT02019719|O4|Outcome|GSK1278863 8 mg|Eligible participant's received GSK1278863 8 mg once daily for the 4 Week treatment period.
91214|NCT02019719|O3|Outcome|GSK1278863 6 mg|Eligible participant's received GSK1278863 6 mg once daily for the 4 Week treatment period.
91215|NCT02019719|O2|Outcome|GSK1278863 4 mg|Eligible participant's received GSK1278863 4 mg once daily for the 4 Week treatment period.
91216|NCT02019719|O1|Outcome|Placebo|Eligible participant's received matching placebo to GSK1278863 once daily for the 4 Week treatment period.
91217|NCT02019719|O5|Outcome|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4 Week treatment period.
91218|NCT02019719|O4|Outcome|GSK1278863 8 mg|Eligible participant's received GSK1278863 8 mg once daily for the 4 Week treatment period.
91219|NCT02019719|O3|Outcome|GSK1278863 6 mg|Eligible participant's received GSK1278863 6 mg once daily for the 4 Week treatment period.
91220|NCT02019719|O2|Outcome|GSK1278863 4 mg|Eligible participant's received GSK1278863 4 mg once daily for the 4 Week treatment period.
91221|NCT02019719|O1|Outcome|Placebo|Eligible participant's received matching placebo to GSK1278863 once daily for the 4 Week treatment period.
91222|NCT02019719|O5|Outcome|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4 Week treatment period.
91223|NCT02019719|O4|Outcome|GSK1278863 8 mg|Eligible participant's received GSK1278863 8 mg once daily for the 4 Week treatment period.
91224|NCT02019719|O3|Outcome|GSK1278863 6 mg|Eligible participant's received GSK1278863 6 mg once daily for the 4 Week treatment period.
91225|NCT02019719|O2|Outcome|GSK1278863 4 mg|Eligible participant's received GSK1278863 4 mg once daily for the 4 Week treatment period.
91226|NCT02019719|O1|Outcome|Placebo|Eligible participant's received matching placebo to GSK1278863 once daily for the 4 Week treatment period.
92727|NCT02012686|O1|Outcome|Control Group|numerical rating scale of TENS non-applied group
91227|NCT02019719|O5|Outcome|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4 Week treatment period.
91228|NCT02019719|O4|Outcome|GSK1278863 8 mg|Eligible participant's received GSK1278863 8 mg once daily for the 4 Week treatment period.
91229|NCT02019719|O3|Outcome|GSK1278863 6 mg|Eligible participant's received GSK1278863 6 mg once daily for the 4 Week treatment period.
91230|NCT02019719|O2|Outcome|GSK1278863 4 mg|Eligible participant's received GSK1278863 4 mg once daily for the 4 Week treatment period.
91231|NCT02019719|O1|Outcome|Placebo|Eligible participant's received matching placebo to GSK1278863 once daily for the 4 Week treatment period.
91232|NCT02019719|O5|Outcome|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4 Week treatment period.
91233|NCT02019719|O4|Outcome|GSK1278863 8 mg|Eligible participant's received GSK1278863 8 mg once daily for the 4 Week treatment period.
91234|NCT02019719|O3|Outcome|GSK1278863 6 mg|Eligible participant's received GSK1278863 6 mg once daily for the 4 Week treatment period.
91235|NCT02019719|O2|Outcome|GSK1278863 4 mg|Eligible participant's received GSK1278863 4 mg once daily for the 4 Week treatment period.
91236|NCT02019719|O1|Outcome|Placebo|Eligible participant's received matching placebo to GSK1278863 once daily for the 4 Week treatment period.
91237|NCT02019719|O5|Outcome|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4 Week treatment period.
91238|NCT02019719|O4|Outcome|GSK1278863 8 mg|Eligible participant's received GSK1278863 8 mg once daily for the 4 Week treatment period.
91239|NCT02019719|O3|Outcome|GSK1278863 6 mg|Eligible participant's received GSK1278863 6 mg once daily for the 4 Week treatment period.
91240|NCT02019719|O2|Outcome|GSK1278863 4 Milligrams (mg)|Eligible participant's received GSK1278863 4 mg once daily for the 4 Week treatment period.
91241|NCT02019719|O1|Outcome|Placebo|Eligible participant's received matching placebo to GSK1278863 once daily for the 4 Week treatment period.
91242|NCT02019719|O5|Outcome|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4 Week treatment period.
91243|NCT02019719|O4|Outcome|GSK1278863 8 mg|Eligible participant's received GSK1278863 8 mg once daily for the 4 Week treatment period.
91244|NCT02019719|O3|Outcome|GSK1278863 6 mg|Eligible participant's received GSK1278863 6 mg once daily for the 4 Week treatment period.
91245|NCT02019719|O2|Outcome|GSK1278863 4 mg|Eligible participant's received GSK1278863 4 mg once daily for the 4 Week treatment period.
91246|NCT02019719|O1|Outcome|Placebo|Eligible participant's received matching placebo to GSK1278863 once daily for the 4 Week treatment period.
91247|NCT02019719|O5|Outcome|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4 Week treatment period.
91248|NCT02019719|O4|Outcome|GSK1278863 8 mg|Eligible participant's received GSK1278863 8 mg once daily for the 4 Week treatment period.
91249|NCT02019719|O3|Outcome|GSK1278863 6 mg|Eligible participant's received GSK1278863 6 mg once daily for the 4 Week treatment period.
91250|NCT02019719|O2|Outcome|GSK1278863 4 mg|Eligible participant's received GSK1278863 4 mg once daily for the 4 Week treatment period.
91251|NCT02019719|O1|Outcome|Placebo|Eligible participant's received matching placebo to GSK1278863 once daily for the 4 Week treatment period.
91252|NCT02019719|O5|Outcome|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4 Week treatment period
91253|NCT02019719|O4|Outcome|GSK1278863 8 mg|Eligible participant's received GSK1278863 8 mg once daily for the 4 Week treatment period.
91254|NCT02019719|O3|Outcome|GSK1278863 6 mg|Eligible participant's received GSK1278863 6 mg once daily for the 4 Week treatment period.
91255|NCT02019719|O2|Outcome|GSK1278863 4 mg|Eligible participant's received GSK1278863 4 mg once daily for the 4 Week treatment period.
91256|NCT02019719|O1|Outcome|Placebo|Eligible participant's received matching placebo to GSK1278863 once daily for the 4 Week treatment period.
91257|NCT02019719|O5|Outcome|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4 Week treatment period.
91258|NCT02019719|O4|Outcome|GSK1278863 8 mg|Eligible participant's received GSK1278863 8 mg once daily for the 4 Week treatment period.
91259|NCT02019719|O3|Outcome|GSK1278863 6 mg|Eligible participant's received GSK1278863 6 mg once daily for the 4 Week treatment period.
91260|NCT02019719|O2|Outcome|GSK1278863 4 mg|Eligible participant's received GSK1278863 4 mg once daily for the 4 Week treatment period.
91261|NCT02019719|O1|Outcome|Placebo|Eligible participant's received matching placebo to GSK1278863 once daily for the 4 Week treatment period.
91262|NCT02019719|O5|Outcome|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4 Week treatment period.
91263|NCT02019719|O4|Outcome|GSK1278863 8 mg|Eligible participant's received GSK1278863 8 mg once daily for the 4 Week treatment period.
91264|NCT02019719|O3|Outcome|GSK1278863 6 mg|Eligible participant's received GSK1278863 6 mg once daily for the 4 Week treatment period.
91265|NCT02019719|O2|Outcome|GSK1278863 4 mg|Eligible participant's received GSK1278863 4 mg once daily for the 4 Week treatment period.
91266|NCT02019719|O1|Outcome|Placebo|Eligible participant's received matching placebo to GSK1278863 once daily for the 4 Week treatment period.
91267|NCT02019719|O5|Outcome|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4 Week treatment period.
91268|NCT02019719|O4|Outcome|GSK1278863 8 mg|Eligible participant's received GSK1278863 8 mg once daily for the 4 Week treatment period.
91269|NCT02019719|O3|Outcome|GSK1278863 6 mg|Eligible participant's received GSK1278863 6 mg once daily for the 4 Week treatment period.
91270|NCT02019719|O2|Outcome|GSK1278863 4 mg|Eligible participant's received GSK1278863 4 mg once daily for the 4 Week treatment period.
91271|NCT02019719|O1|Outcome|Placebo|Eligible participant's received matching placebo to GSK1278863 once daily for the 4 Week treatment period.
91272|NCT02019719|O5|Outcome|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4 Week treatment period.
91273|NCT02019719|O4|Outcome|GSK1278863 8 mg|Eligible participant's received GSK1278863 8 mg once daily for the 4 Week treatment period.
91274|NCT02019719|O3|Outcome|GSK1278863 6 mg|Eligible participant's received GSK1278863 6 mg once daily for the 4 Week treatment period.
94255|NCT02005211|O5|Outcome|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
91275|NCT02019719|O2|Outcome|GSK1278863 4 mg|Eligible participant's received GSK1278863 4 mg once daily for the 4 Week treatment period.
91276|NCT02019719|O1|Outcome|Placebo|Eligible participant's received matching placebo to GSK1278863 once daily for the 4 Week treatment period.
91277|NCT02019719|O5|Outcome|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4 Week treatment period.
91278|NCT02019719|O4|Outcome|GSK1278863 8 mg|Eligible participant's received GSK1278863 8 mg once daily for the 4 Week treatment period.
91279|NCT02019719|O3|Outcome|GSK1278863 6 mg|Eligible participant's received GSK1278863 6 mg once daily for the 4 Week treatment period.
91280|NCT02019719|O2|Outcome|GSK1278863 4 mg|Eligible participant's received GSK1278863 4 mg once daily for the 4 Week treatment period.
91281|NCT02019719|O1|Outcome|Placebo|Eligible participant's received matching placebo to GSK1278863 once daily for the 4 Week treatment period.
91282|NCT02019719|O5|Outcome|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4 Week treatment period.
91283|NCT02019719|O4|Outcome|GSK1278863 8 mg|Eligible participant's received GSK1278863 8 mg once daily for the 4 Week treatment period.
91284|NCT02019719|O3|Outcome|GSK1278863 6 mg|Eligible participant's received GSK1278863 6 mg once daily for the 4 Week treatment period.
91285|NCT02019719|O2|Outcome|GSK1278863 4 mg|Eligible participant's received GSK1278863 4 mg once daily for the 4 Week treatment period.
91286|NCT02019719|O1|Outcome|Placebo|Eligible participant's received matching placebo to GSK1278863 once daily for the 4 Week treatment period.
91287|NCT02019719|O5|Outcome|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4 Week treatment period.
91288|NCT02019719|O4|Outcome|GSK1278863 8 mg|Eligible participant's received GSK1278863 8 mg once daily for the 4 Week treatment period.
91289|NCT02019719|O3|Outcome|GSK1278863 6 mg|Eligible participant's received GSK1278863 6 mg once daily for the 4 Week treatment period.
91290|NCT02019719|O2|Outcome|GSK1278863 4 mg|Eligible participant's received GSK1278863 4 mg once daily for the 4 Week treatment period.
91291|NCT02019719|O1|Outcome|Placebo|Eligible participant's received matching placebo to GSK1278863 once daily for the 4 Week treatment period.
91292|NCT02019719|O5|Outcome|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4 Week treatment period.
91293|NCT02019719|O4|Outcome|GSK1278863 8 mg|Eligible participant's received GSK1278863 8 mg once daily for the 4 Week treatment period.
91294|NCT02019719|O3|Outcome|GSK1278863 6 mg|Eligible participant's received GSK1278863 6 mg once daily for the 4 Week treatment period.
91295|NCT02019719|O2|Outcome|GSK1278863 4 mg|Eligible participant's received GSK1278863 4 mg once daily for the 4 Week treatment period.
91296|NCT02019719|O1|Outcome|Placebo|Eligible participant's received matching placebo to GSK1278863 once daily for the 4 Week treatment period.
91297|NCT02019719|O5|Outcome|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4 weeks treatment period.
91298|NCT02019719|O4|Outcome|GSK1278863 8 mg|Eligible participant's received GSK1278863 8 mg once daily for the 4 weeks treatment period.
91299|NCT02019719|O3|Outcome|GSK1278863 6 mg|Eligible participant's received GSK1278863 6 mg once daily for the 4 weeks treatment period.
91300|NCT02019719|O2|Outcome|GSK1278863 4 mg|Eligible participant's received GSK1278863 4 mg once daily for the 4 weeks treatment period.
91301|NCT02019719|O1|Outcome|Placebo|Eligible participant's received matching placebo to GSK1278863 once daily for the 4W treatment period.
91302|NCT02019719|E5|Reported Event|GSK1278863 10 mg|Eligible participant's received GSK1278863 10 mg once daily for the 4W treatment period.
91303|NCT02019719|E4|Reported Event|GSK1278863 8 mg|Eligible participant's received GSK1278863 8 mg once daily for the 4W treatment period.
91304|NCT02019719|E3|Reported Event|GSK1278863 6 mg|Eligible participant's received GSK1278863 6 mg once daily for the 4W treatment period.
91305|NCT02019719|E2|Reported Event|GSK1278863 4 mg|Eligible participant's received GSK1278863 4 mg once daily for the 4W treatment period.
91306|NCT02019719|E1|Reported Event|Placebo|Eligible participant's received matching placebo to GSK1278863 once daily for the 4W treatment period.
91307|NCT02019563|B3|Baseline|Total|Total of all reporting groups
91308|NCT02019563|B2|Baseline|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
91309|NCT02019563|B1|Baseline|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
91310|NCT02019563|P2|Participant Flow|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
91311|NCT02019563|P1|Participant Flow|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
91312|NCT02019563|O2|Outcome|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
91802|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
91313|NCT02019563|O1|Outcome|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
91314|NCT02019563|O2|Outcome|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~RCT Group: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
91315|NCT02019563|O1|Outcome|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~MTA/FS pulpotomy Group: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
91316|NCT02019563|O2|Outcome|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~RCT Group: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
91317|NCT02019563|O1|Outcome|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~MTA/FS pulpotomy Group: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
91318|NCT02019563|O2|Outcome|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
91319|NCT02019563|O1|Outcome|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
91320|NCT02019563|O2|Outcome|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
91321|NCT02019563|O1|Outcome|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
91322|NCT02019563|E2|Reported Event|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
91323|NCT02019563|E1|Reported Event|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
91324|NCT02019550|B3|Baseline|Total|Total of all reporting groups
91325|NCT02019550|B2|Baseline|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
91326|NCT02019550|B1|Baseline|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
91327|NCT02019550|P2|Participant Flow|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
91328|NCT02019550|P1|Participant Flow|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 microgram (mcg) subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
91329|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
91330|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
91331|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
91332|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
91333|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
91334|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
91335|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
91336|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
91337|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
91338|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
91339|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
91340|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
91341|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
91342|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
91343|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
91344|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
91345|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
91346|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
91347|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
91392|NCT02018809|B4|Baseline|Usual Care|"Usual care with GlowCap.~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
91348|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
91349|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
91350|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
91351|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
91352|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
91353|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
91354|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
91355|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
91356|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
91357|NCT02019550|O2|Outcome|Rebiject II|Subjects who were injected with Rebif 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in either Treatment Period 1 or 2.
91358|NCT02019550|O1|Outcome|Rebif Rebidose|Subjects who were injected with Rebif 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in either Treatment Period 1 or 2.
91359|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
91360|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
91361|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
91362|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
91363|NCT02019550|E2|Reported Event|Rebiject II|Subjects who were injected with Rebif 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in either Treatment Period 1 or 2.
91364|NCT02019550|E1|Reported Event|Rebif Rebidose|Subjects who were injected with Rebif 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in either Treatment Period 1 or 2.
91365|NCT02019472|B4|Baseline|Total|Total of all reporting groups
91366|NCT02019472|B3|Baseline|Sirukumab 100 mg|Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.
91367|NCT02019472|B2|Baseline|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
91368|NCT02019472|B1|Baseline|Adalimumab 40 mg|Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
91415|NCT02018562|P2|Participant Flow|Control|This group will also receive talking tracheostomy tube trial as standard of care but a week later after the pre and post assessments have been completed
91369|NCT02019472|P3|Participant Flow|Sirukumab 100 mg|Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.
91370|NCT02019472|P2|Participant Flow|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
91371|NCT02019472|P1|Participant Flow|Adalimumab 40 mg|Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
91372|NCT02019472|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.
91373|NCT02019472|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
91374|NCT02019472|O1|Outcome|Adalimumab 40 mg|Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
91375|NCT02019472|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.
91376|NCT02019472|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
91377|NCT02019472|O1|Outcome|Adalimumab 40 mg|Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
91378|NCT02019472|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.
91379|NCT02019472|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
91380|NCT02019472|O1|Outcome|Adalimumab 40 mg|Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
91381|NCT02019472|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.
91382|NCT02019472|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
91383|NCT02019472|O1|Outcome|Adalimumab 40 mg|Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
91384|NCT02019472|E7|Reported Event|Sirukumab 100 mg|Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.
91385|NCT02019472|E6|Reported Event|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
91386|NCT02019472|E5|Reported Event|Sirukumab 50 mg q4w Then 100 mg q2w|Participants received 50 mg sirukumab until Week 16 and received 100 mg sirukumab subcutaneously q4w (due to EE or inadvertently) through Week 52.
91387|NCT02019472|E4|Reported Event|Sirukumab 50 mg q4w Only|Participants received 50 mg of sirukumab subcutaneously every four weeks (q4w) for 52 weeks.
91388|NCT02019472|E3|Reported Event|Adalimumab 40 mg|Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
91389|NCT02019472|E2|Reported Event|Adalimumab 40 mg q2w Then 40 mg q1w|Participants received 40 mg adalimumab subcutaneously q2w until Week 16 and received 40 mg adalimumab subcutaneously weekly (q1w) (due to EE) through Week 52.
91390|NCT02019472|E1|Reported Event|Adalimumab 40 mg q2w Only|Participants received 40 mg of adalimumab subcutaneously q2w for 52 weeks.
91391|NCT02018809|B5|Baseline|Total|Total of all reporting groups
91393|NCT02018809|B3|Baseline|MAP Missed Doses|"The subject’s MAP receives notification if the subject missed >2 consecutive daily doses of statin.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
91394|NCT02018809|B2|Baseline|MAP Weekly Notification|"The subject’s MAP receives weekly about how often the subject took statin during previous week.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
91395|NCT02018809|B1|Baseline|MAP Daily Notification|"The subject’s MAP receives daily notification about whether subject took statin.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
91396|NCT02018809|P4|Participant Flow|Usual Care|"Usual care with GlowCap.~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
91397|NCT02018809|P3|Participant Flow|MAP Missed Doses|"The subject’s MAP receives notification if the subject missed >2 consecutive daily doses of statin.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
91398|NCT02018809|P2|Participant Flow|MAP Weekly Notification|"The subject’s MAP receives weekly about how often the subject took statin during previous week.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
91399|NCT02018809|P1|Participant Flow|MAP Daily Notification|"The subject’s MAP receives daily notification about whether subject took statin.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
91400|NCT02018809|O4|Outcome|Usual Care|"Usual care with GlowCap.~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
91401|NCT02018809|O3|Outcome|MAP Missed Doses|"The subject’s MAP receives notification if the subject missed >2 consecutive daily doses of statin.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
91402|NCT02018809|O2|Outcome|MAP Weekly Notification|"The subject’s MAP receives weekly about how often the subject took statin during previous week.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
91403|NCT02018809|O1|Outcome|MAP Daily Notification|"The subject’s MAP receives daily notification about whether subject took statin.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
91404|NCT02018809|O4|Outcome|Usual Care|"Usual care with GlowCap.~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
91405|NCT02018809|O3|Outcome|MAP Missed Doses|"The subject’s MAP receives notification if the subject missed >2 consecutive daily doses of statin.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
91406|NCT02018809|O2|Outcome|MAP Weekly Notification|"The subject’s MAP receives weekly about how often the subject took statin during previous week.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
91407|NCT02018809|O1|Outcome|MAP Daily Notification|"The subject’s MAP receives daily notification about whether subject took statin.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
91408|NCT02018809|E4|Reported Event|Usual Care|"Usual care with GlowCap.~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
91409|NCT02018809|E3|Reported Event|MAP Missed Doses|"The subject’s MAP receives notification if the subject missed >2 consecutive daily doses of statin.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
91410|NCT02018809|E2|Reported Event|MAP Weekly Notification|"The subject’s MAP receives weekly about how often the subject took statin during previous week.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
91411|NCT02018809|E1|Reported Event|MAP Daily Notification|"The subject’s MAP receives daily notification about whether subject took statin.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
91412|NCT02018562|B3|Baseline|Total|Total of all reporting groups
91413|NCT02018562|B2|Baseline|Control|This group will also receive talking tracheostomy tube trial as standard of care but a week later after the pre and post assessments have been completed
91414|NCT02018562|B1|Baseline|Intervention|"This involves placement of a talking tracheostomy tube (Portex Blueline Ultra Suctionaid Tracheostomy Tube) by respiratory therapist after obtaining an order from an authorized prescriber (Physician or Nurse Practitioner). The Speech-Language Pathologist (SLP) sets up the tracheostomy tube for speech and then determines the optimal air flow required for voicing. This amount of air flow is communicated to the ICU staff for further use.~We will ensure that the SLP meets with the patient for a minimum of 3 sessions within a week to optimize the use of a talking tracheostomy tube.~i. SLP will also assess the duration of successful speech during each session. ii. Sentence intelligibility will also be assessed during the 3rd session. This session will be audio-taped and reviewed by a second rater for sentence intelligibility.~iii. SLP will determine the level of independence with talking tracheostomy during the 3rd session.~Portex Blueline Ultra Suctionaid Tracheostomy Tube"
91416|NCT02018562|P1|Participant Flow|Intervention|"This involves placement of a talking tracheostomy tube (Portex Blueline Ultra Suctionaid Tracheostomy Tube) by respiratory therapist after obtaining an order from an authorized prescriber (Physician or Nurse Practitioner). The Speech-Language Pathologist (SLP) sets up the tracheostomy tube for speech and then determines the optimal air flow required for voicing. This amount of air flow is communicated to the ICU staff for further use.~We will ensure that the SLP meets with the patient for a minimum of 3 sessions within a week to optimize the use of a talking tracheostomy tube.~i. SLP will also assess the duration of successful speech during each session. ii. Sentence intelligibility will also be assessed during the 3rd session. This session will be audio-taped and reviewed by a second rater for sentence intelligibility.~iii. SLP will determine the level of independence with talking tracheostomy during the 3rd session.~Portex Blueline Ultra Suctionaid Tracheostomy Tube"
91417|NCT02018562|O2|Outcome|Control|This group will also receive talking tracheostomy tube trial as standard of care but a week later after the pre and post assessments have been completed
91418|NCT02018562|O1|Outcome|Intervention|"This involves placement of a talking tracheostomy tube (Portex Blueline Ultra Suctionaid Tracheostomy Tube) by respiratory therapist after obtaining an order from an authorized prescriber (Physician or Nurse Practitioner). The Speech-Language Pathologist (SLP) sets up the tracheostomy tube for speech and then determines the optimal air flow required for voicing. This amount of air flow is communicated to the ICU staff for further use.~We will ensure that the SLP meets with the patient for a minimum of 3 sessions within a week to optimize the use of a talking tracheostomy tube.~i. SLP will also assess the duration of successful speech during each session. ii. Sentence intelligibility will also be assessed during the 3rd session. This session will be audio-taped and reviewed by a second rater for sentence intelligibility.~iii. SLP will determine the level of independence with talking tracheostomy during the 3rd session.~Portex Blueline Ultra Suctionaid Tracheostomy Tube"
91419|NCT02018562|O2|Outcome|Control|This group will also receive talking tracheostomy tube trial as standard of care but a week later after the pre and post assessments have been completed
91420|NCT02018562|O1|Outcome|Intervention|"This involves placement of a talking tracheostomy tube (Portex Blueline Ultra Suctionaid Tracheostomy Tube) by respiratory therapist after obtaining an order from an authorized prescriber (Physician or Nurse Practitioner). The Speech-Language Pathologist (SLP) sets up the tracheostomy tube for speech and then determines the optimal air flow required for voicing. This amount of air flow is communicated to the ICU staff for further use.~We will ensure that the SLP meets with the patient for a minimum of 3 sessions within a week to optimize the use of a talking tracheostomy tube.~i. SLP will also assess the duration of successful speech during each session. ii. Sentence intelligibility will also be assessed during the 3rd session. This session will be audio-taped and reviewed by a second rater for sentence intelligibility.~iii. SLP will determine the level of independence with talking tracheostomy during the 3rd session.~Portex Blueline Ultra Suctionaid Tracheostomy Tube"
91421|NCT02018562|O2|Outcome|Control|This group will also receive talking tracheostomy tube trial as standard of care but a week later after the pre and post assessments have been completed
91422|NCT02018562|O1|Outcome|Intervention|"This involves placement of a talking tracheostomy tube (Portex Blueline Ultra Suctionaid Tracheostomy Tube) by respiratory therapist after obtaining an order from an authorized prescriber (Physician or Nurse Practitioner). The Speech-Language Pathologist (SLP) sets up the tracheostomy tube for speech and then determines the optimal air flow required for voicing. This amount of air flow is communicated to the ICU staff for further use.~We will ensure that the SLP meets with the patient for a minimum of 3 sessions within a week to optimize the use of a talking tracheostomy tube.~i. SLP will also assess the duration of successful speech during each session. ii. Sentence intelligibility will also be assessed during the 3rd session. This session will be audio-taped and reviewed by a second rater for sentence intelligibility.~iii. SLP will determine the level of independence with talking tracheostomy during the 3rd session.~Portex Blueline Ultra Suctionaid Tracheostomy Tube"
91423|NCT02018562|O2|Outcome|Control|This group will also receive talking tracheostomy tube trial as standard of care but a week later after the pre and post assessments have been completed
91424|NCT02018562|O1|Outcome|Intervention|"This involves placement of a talking tracheostomy tube (Portex Blueline Ultra Suctionaid Tracheostomy Tube) by respiratory therapist after obtaining an order from an authorized prescriber (Physician or Nurse Practitioner). The Speech-Language Pathologist (SLP) sets up the tracheostomy tube for speech and then determines the optimal air flow required for voicing. This amount of air flow is communicated to the ICU staff for further use.~We will ensure that the SLP meets with the patient for a minimum of 3 sessions within a week to optimize the use of a talking tracheostomy tube.~i. SLP will also assess the duration of successful speech during each session. ii. Sentence intelligibility will also be assessed during the 3rd session. This session will be audio-taped and reviewed by a second rater for sentence intelligibility.~iii. SLP will determine the level of independence with talking tracheostomy during the 3rd session.~Portex Blueline Ultra Suctionaid Tracheostomy Tube"
91425|NCT02018562|O2|Outcome|Control|This group will also receive talking tracheostomy tube trial as standard of care but a week later after the pre and post assessments have been completed
91426|NCT02018562|O1|Outcome|Intervention|"This involves placement of a talking tracheostomy tube (Portex Blueline Ultra Suctionaid Tracheostomy Tube) by respiratory therapist after obtaining an order from an authorized prescriber (Physician or Nurse Practitioner). The Speech-Language Pathologist (SLP) sets up the tracheostomy tube for speech and then determines the optimal air flow required for voicing. This amount of air flow is communicated to the ICU staff for further use.~We will ensure that the SLP meets with the patient for a minimum of 3 sessions within a week to optimize the use of a talking tracheostomy tube.~i. SLP will also assess the duration of successful speech during each session. ii. Sentence intelligibility will also be assessed during the 3rd session. This session will be audio-taped and reviewed by a second rater for sentence intelligibility.~iii. SLP will determine the level of independence with talking tracheostomy during the 3rd session.~Portex Blueline Ultra Suctionaid Tracheostomy Tube"
91427|NCT02018562|O2|Outcome|Control|This group will also receive talking tracheostomy tube trial as standard of care but a week later after the pre and post assessments have been completed
91449|NCT02017093|O2|Outcome|Control Group|"Training of the upper extremity, using a robotic devise without forces applied and traditional therapy.~control treatment: Patients underwent upper extremity robotic training without the error enhancement effect. Training have focused on hand reaching movements in varity of directions and range of motions."
91428|NCT02018562|O1|Outcome|Intervention|"This involves placement of a talking tracheostomy tube (Portex Blueline Ultra Suctionaid Tracheostomy Tube) by respiratory therapist after obtaining an order from an authorized prescriber (Physician or Nurse Practitioner). The Speech-Language Pathologist (SLP) sets up the tracheostomy tube for speech and then determines the optimal air flow required for voicing. This amount of air flow is communicated to the ICU staff for further use.~We will ensure that the SLP meets with the patient for a minimum of 3 sessions within a week to optimize the use of a talking tracheostomy tube.~i. SLP will also assess the duration of successful speech during each session. ii. Sentence intelligibility will also be assessed during the 3rd session. This session will be audio-taped and reviewed by a second rater for sentence intelligibility.~iii. SLP will determine the level of independence with talking tracheostomy during the 3rd session.~Portex Blueline Ultra Suctionaid Tracheostomy Tube"
91429|NCT02018562|O2|Outcome|Control|This group will also receive talking tracheostomy tube trial as standard of care but a week later after the pre and post assessments have been completed
91430|NCT02018562|O1|Outcome|Intervention|"This involves placement of a talking tracheostomy tube (Portex Blueline Ultra Suctionaid Tracheostomy Tube) by respiratory therapist after obtaining an order from an authorized prescriber (Physician or Nurse Practitioner). The Speech-Language Pathologist (SLP) sets up the tracheostomy tube for speech and then determines the optimal air flow required for voicing. This amount of air flow is communicated to the ICU staff for further use.~We will ensure that the SLP meets with the patient for a minimum of 3 sessions within a week to optimize the use of a talking tracheostomy tube.~i. SLP will also assess the duration of successful speech during each session. ii. Sentence intelligibility will also be assessed during the 3rd session. This session will be audio-taped and reviewed by a second rater for sentence intelligibility.~iii. SLP will determine the level of independence with talking tracheostomy during the 3rd session.~Portex Blueline Ultra Suctionaid Tracheostomy Tube"
91431|NCT02018562|E2|Reported Event|Control|This group will also receive talking tracheostomy tube trial as standard of care but a week later after the pre and post assessments have been completed
91432|NCT02018562|E1|Reported Event|Intervention|"This involves placement of a talking tracheostomy tube (Portex Blueline Ultra Suctionaid Tracheostomy Tube) by respiratory therapist after obtaining an order from an authorized prescriber (Physician or Nurse Practitioner). The Speech-Language Pathologist (SLP) sets up the tracheostomy tube for speech and then determines the optimal air flow required for voicing. This amount of air flow is communicated to the ICU staff for further use.~We will ensure that the SLP meets with the patient for a minimum of 3 sessions within a week to optimize the use of a talking tracheostomy tube.~i. SLP will also assess the duration of successful speech during each session. ii. Sentence intelligibility will also be assessed during the 3rd session. This session will be audio-taped and reviewed by a second rater for sentence intelligibility.~iii. SLP will determine the level of independence with talking tracheostomy during the 3rd session.~Portex Blueline Ultra Suctionaid Tracheostomy Tube"
91433|NCT02017574|B3|Baseline|Total|Total of all reporting groups
91434|NCT02017574|B2|Baseline|Control|"Receives detailed feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
91435|NCT02017574|B1|Baseline|Implicit Group|"Receives little feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
91436|NCT02017574|P2|Participant Flow|Control|"Receives detailed feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
91437|NCT02017574|P1|Participant Flow|Implicit Group|"Receives little feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
91438|NCT02017574|O2|Outcome|Control|"Receives detailed feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
91439|NCT02017574|O1|Outcome|Implicit Group|"Receives little feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
91440|NCT02017574|O2|Outcome|Control|"Receives detailed feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
91441|NCT02017574|O1|Outcome|Implicit Group|"Receives little feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
91442|NCT02017574|E2|Reported Event|Control|"Receives detailed feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
91443|NCT02017574|E1|Reported Event|Implicit Group|"Receives little feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
91444|NCT02017093|B3|Baseline|Total|Total of all reporting groups
91445|NCT02017093|B2|Baseline|Control|Patients admitted to rehabilitation center after a stroke.
91446|NCT02017093|B1|Baseline|Study|Patients admitted to rehabilitation center after a stroke.
91447|NCT02017093|P2|Participant Flow|Control Group: Traditional Therapy|"Training of the upper extremity, using a robotic deviset without forces applied and traditional therapy.~Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement~Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
91448|NCT02017093|P1|Participant Flow|Error Enhancement|"Training of the upper extremity, using a robotic deviset with error enhanced forces and traditional therapy.~Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement~Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
91470|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
91450|NCT02017093|O1|Outcome|Error Enhancement|"Training of the upper extremity, using a robotic devise with error enhanced forces and traditional therapy.~Error Enhancement: Patients underwent upper extremity robotic training with the error enhancement effect. Training have focused on hand reaching movements in varity of directions and range of motions."
91451|NCT02017093|O2|Outcome|Control Group: Traditional Therapy|"Training of the upper extremity, using a robotic deviset without forces applied and traditional therapy.~Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement~Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
91452|NCT02017093|O1|Outcome|Error Enhancement|"Training of the upper extremity, using a robotic deviset with error enhanced forces and traditional therapy.~Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement~Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
91453|NCT02017093|E2|Reported Event|Control Group: Traditional Therapy|"Training of the upper extremity, using a robotic deviset without forces applied and traditional therapy.~Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement~Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
91454|NCT02017093|E1|Reported Event|Error Enhancement|"Training of the upper extremity, using a robotic deviset with error enhanced forces and traditional therapy.~Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement~Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
91455|NCT02017015|B1|Baseline|Nab-paclitaxel and Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
91456|NCT02017015|P1|Participant Flow|Nab-paclitaxel and Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 by IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
91457|NCT02017015|O1|Outcome|Nab-paclitaxel With Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
91458|NCT02017015|O1|Outcome|Nab-paclitaxel With Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
91459|NCT02017015|O1|Outcome|Nab-paclitaxel and Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
91460|NCT02017015|O1|Outcome|Nab-paclitaxel and Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
91461|NCT02017015|E1|Reported Event|Nab-paclitaxel and Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
91462|NCT02016963|B1|Baseline|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
91463|NCT02016963|P1|Participant Flow|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
91464|NCT02016963|O1|Outcome|Raxibacumab IV|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
91465|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
91466|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
91467|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
91468|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
91469|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
94256|NCT02005211|O4|Outcome|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
91471|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
91472|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
91473|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
91474|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
91475|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
91476|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
91477|NCT02016963|E1|Reported Event|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
91478|NCT02016898|B3|Baseline|Total|Total of all reporting groups
91479|NCT02016898|B2|Baseline|Irrigation Placement of Mitomycin-C|"Randomization will be stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery.~Irrigation placement~Mitomycin-C"
91480|NCT02016898|B1|Baseline|Sponge Placement of Mitomycin-C|"Randomization will be stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery.~Placement of the sponge~Mitomycin-C"
91481|NCT02016898|P2|Participant Flow|Irrigation Placement of Mitomycin-C|"Randomization stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery.~Irrigation placement~Mitomycin-C"
91482|NCT02016898|P1|Participant Flow|Sponge Placement of Mitomycin-C|"Randomization stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery.~Placement of the sponge~Mitomycin-C"
91483|NCT02016898|O2|Outcome|Irrigation Placement of MMC|"Randomization will be stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery.~Irrigation placement~Mitomycin-C"
91484|NCT02016898|O1|Outcome|Sponge Placement of Mitomycin-C|"Randomization stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery.~Placement of the sponge~Mitomycin-C"
91485|NCT02016898|O2|Outcome|Irrigation Placement of MMC|"Randomization will be stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery.~Irrigation placement~Mitomycin-C"
91486|NCT02016898|O1|Outcome|Sponge Placement of Mitomycin-C|"Randomization stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery.~Placement of the sponge~Mitomycin-C"
91487|NCT02016898|E2|Reported Event|Irrigation Placement of Mitomycin-C|"Randomization stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery.~Irrigation placement~Mitomycin-C"
91488|NCT02016898|E1|Reported Event|Sponge Placement of Mitomycin-C|"Randomization stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery.~Placement of the sponge~Mitomycin-C"
91489|NCT02016690|B1|Baseline|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
91490|NCT02016690|P1|Participant Flow|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
91491|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
91492|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
91493|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
91494|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
91495|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
91496|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
91497|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
91498|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
91499|NCT02016690|E1|Reported Event|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
91500|NCT02016625|B3|Baseline|Total|Total of all reporting groups
91501|NCT02016625|B2|Baseline|Tacrolimus / Tacrolimus + Faldaprevir|fixed sequence group 2: single dose of 0.5 mg tac on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 0.5 mg tac on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods.
91502|NCT02016625|B1|Baseline|Cyclosporine / Cyclosporine + Faldaprevir|fixed sequence group 1: single dose of 50 mg cyclo on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 50 mg cyclo on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods.
91503|NCT02016625|P2|Participant Flow|Tacrolimus / Tacrolimus + Faldaprevir|fixed sequence group 2: single dose of 0.5 mg tac on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 0.5 mg tac on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods.
91504|NCT02016625|P1|Participant Flow|Cyclosporine / Cyclosporine + Faldaprevir|fixed sequence group 1: single dose of 50 mg cyclo on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 50 mg cyclo on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods.
91505|NCT02016625|O2|Outcome|Tacrolimus + Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 0.5 mg tac on Day 1 in period 2.
91506|NCT02016625|O1|Outcome|Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7 [followed by tac treatment] in period 2.
91507|NCT02016625|O2|Outcome|Tacrolimus + Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 0.5 mg tac on Day 1 in period 2.
91508|NCT02016625|O1|Outcome|Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7 [followed by tac treatment] in period 2.
91509|NCT02016625|O2|Outcome|Tacrolimus + Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 0.5 mg tac on Day 1 in period 2.
91510|NCT02016625|O1|Outcome|Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 1 [followed by tac treatment] in period 2
91511|NCT02016625|O2|Outcome|Tacrolimus + Faldaprevir|fixed sequence group 2: treated with tac 0.5 mg on Day 1 in period 1, treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 0.5 mg tac on Day 1 in period 2.
91512|NCT02016625|O1|Outcome|Tacrolimus|fixed sequence group 2: treated with tac 0.5 mg on Day 1 in period 1.
91513|NCT02016625|O2|Outcome|Tacrolimus + Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 0.5 mg tac on Day 1 in period 2.
91514|NCT02016625|O1|Outcome|Tacrolimus|fixed sequence group 2: treated with tac 0.5 mg on Day 1 in period 1.
91515|NCT02016625|O2|Outcome|Tacrolimus + Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 0.5 mg tac on Day 1 in period 2.
91516|NCT02016625|O1|Outcome|Tacrolimus|fixed sequence group 2: treated with tac 0.5 mg on Day 1 in period 1.
91517|NCT02016625|O2|Outcome|Cyclosporine + Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
91518|NCT02016625|O1|Outcome|Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 1 [followed by cyclo treatment] in period 2
91519|NCT02016625|O2|Outcome|Cyclosporine + Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
91520|NCT02016625|O1|Outcome|Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 1 [followed by cyclo treatment] in period 2
91521|NCT02016625|O2|Outcome|Cyclosporine + Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
91522|NCT02016625|O1|Outcome|Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 1 [followed by cyclo treatment] in period 2
91523|NCT02016625|O2|Outcome|Cyclosporine + Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
91524|NCT02016625|O1|Outcome|Cyclosporine|fixed sequence group 1: treated with cyclo 50 mg on Day 1 in period 1.
91525|NCT02016625|O2|Outcome|Cyclosporine + Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
91526|NCT02016625|O1|Outcome|Cyclosporine|fixed sequence group 1: treated with cyclo 50 mg on Day 1 in period 1.
91527|NCT02016625|O2|Outcome|Cyclosporine + Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
91528|NCT02016625|O1|Outcome|Cyclosporine|fixed sequence group 1: treated with cyclo 50 mg on Day 1 in period 1.
91529|NCT02016625|E6|Reported Event|Tac+FDV|Tacrolimus 0.5 mg + FDV 120 mg
91530|NCT02016625|E5|Reported Event|Cyclo+FDV|Cyclosporine 50 mg + FDV 120 mg
91531|NCT02016625|E4|Reported Event|FDV (ff Tac)|FDV 120 mg (followed by tacrolimus)
91532|NCT02016625|E3|Reported Event|FDV (ff Cyclo)|FDV 120 mg (followed by cyclosporine)
91533|NCT02016625|E2|Reported Event|Tacrolimus (Tac)|Tacrolimus (tac) 0.5 mg
91534|NCT02016625|E1|Reported Event|Cyclosporine (Cyclo)|Cyclosporine (cyclo) 50 mg
91535|NCT02016612|B5|Baseline|Total|Total of all reporting groups
91536|NCT02016612|B4|Baseline|Augmentation Mastopexy, Implant and Seri|"Augmentation Mastopexy patients where Seri Scaffold is placed~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
91537|NCT02016612|B3|Baseline|Breast Reduction With Seri Support|"Patients undergoing breast reduction with the use of Seri support~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
91538|NCT02016612|B2|Baseline|Mastopexy, Implant no Seri Scaffold|"Mastopexy with implant, No Seri support is used~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
92036|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
91539|NCT02016612|B1|Baseline|Reduction, Mastopexy No Implant, No Seri|"Patients undergoing reduction or mastopexy but no implant is used and no Seri support~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
91540|NCT02016612|P4|Participant Flow|Augmentation Mastopexy, Implant and Seri|"Augmentation Mastopexy patients where Seri Scaffold is placed~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
91541|NCT02016612|P3|Participant Flow|Breast Reduction With Seri Support|"Patients undergoing breast reduction with the use of Seri support~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
91542|NCT02016612|P2|Participant Flow|Mastopexy, Implant no Seri Scaffold|"Mastopexy with implant, No Seri support is used~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
91543|NCT02016612|P1|Participant Flow|Reduction, Mastopexy No Implant, No Seri|"Patients undergoing reduction or mastopexy but no implant is used and no Seri support~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
91544|NCT02016612|O4|Outcome|Augmentation Mastopexy, Implant and Seri|"Augmentation Mastopexy patients where Seri Scaffold is placed~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
91545|NCT02016612|O3|Outcome|Breast Reduction With Seri Support|"Patients undergoing breast reduction with the use of Seri support~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
91546|NCT02016612|O2|Outcome|Mastopexy, Implant no Seri Scaffold|"Mastopexy with implant, No Seri support is used~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
91547|NCT02016612|O1|Outcome|Reduction, Mastopexy No Implant, No Seri|"Patients undergoing reduction or mastopexy but no implant is used and no Seri support~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
91548|NCT02016612|O4|Outcome|Augmentation Mastopexy, Implant and Seri|"Augmentation Mastopexy patients where Seri Scaffold is placed~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
91549|NCT02016612|O3|Outcome|Breast Reduction With Seri Support|"Patients undergoing breast reduction with the use of Seri support~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
91550|NCT02016612|O2|Outcome|Mastopexy, Implant no Seri Scaffold|"Mastopexy with implant, No Seri support is used~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
91551|NCT02016612|O1|Outcome|Reduction, Mastopexy No Implant, No Seri|"Patients undergoing reduction or mastopexy but no implant is used and no Seri support~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
91552|NCT02016612|E4|Reported Event|Augmentation Mastopexy, Implant and Seri|"Augmentation Mastopexy patients where Seri Scaffold is placed~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
91553|NCT02016612|E3|Reported Event|Breast Reduction With Seri Support|"Patients undergoing breast reduction with the use of Seri support~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
91554|NCT02016612|E2|Reported Event|Mastopexy, Implant no Seri Scaffold|"Mastopexy with implant, No Seri support is used~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
91555|NCT02016612|E1|Reported Event|Reduction, Mastopexy No Implant, No Seri|"Patients undergoing reduction or mastopexy but no implant is used and no Seri support~Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast."
91556|NCT02016482|B3|Baseline|Total|Total of all reporting groups
91557|NCT02016482|B2|Baseline|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91558|NCT02016482|B1|Baseline|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91559|NCT02016482|P2|Participant Flow|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91560|NCT02016482|P1|Participant Flow|Placebo|Period A: Placebo subcutaneous every other week (sc eow) for 25 weeks. Period B: Adalimumab (ADA) 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91561|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91562|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91563|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91564|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91565|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91566|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91567|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91568|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91569|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91570|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91571|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91572|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91573|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91574|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91575|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91576|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91577|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91578|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91579|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91580|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91581|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91582|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91583|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91584|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91585|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91586|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91587|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91588|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91589|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91590|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91591|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91592|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91593|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91594|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91595|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91596|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91597|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91598|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91599|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91600|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91601|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91602|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91603|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91604|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91605|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91606|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91607|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91608|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91609|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91610|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91611|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91612|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91613|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91614|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91615|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91616|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91617|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91618|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91619|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91620|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91621|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91622|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91623|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91624|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91625|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91626|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91627|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91628|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91629|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91630|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91631|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91632|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91633|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91634|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91635|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91636|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91637|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91638|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91639|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91640|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91641|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91642|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91643|NCT02016482|E4|Reported Event|Adalimumab EOW/Adalimumab EOW (Period B)|Following Period A (ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg), placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91644|NCT02016482|E3|Reported Event|Placebo/Adalimumab EOW (Period B)|Following Period A (placebo sc eow for 25 weeks), ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91645|NCT02016482|E2|Reported Event|Adalimumab EOW (Period A)|ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg.
91646|NCT02016482|E1|Reported Event|Placebo (Period A)|Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
91647|NCT02016170|B4|Baseline|Total|Total of all reporting groups
91648|NCT02016170|B3|Baseline|Prasugrel 10mg|Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7±2 days
91649|NCT02016170|B2|Baseline|Ticagrelor 90mg|Patients on prasugrel will switch to ticagrelor with a 90mg maintenance dose followed by 90 mg BID maintenance dose for 7±2 days
91650|NCT02016170|B1|Baseline|Ticagrelor 180mg|Patients on prasugrel will switch to ticagrelor with a 180mg loading dose followed by 90 mg BID maintenance dose for 7±2 days.
91651|NCT02016170|P3|Participant Flow|Prasugrel 10mg|Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7±2 days
91652|NCT02016170|P2|Participant Flow|Ticagrelor 90mg|Patients on prasugrel will switch to ticagrelor with a 90mg maintenance dose followed by 90 mg BID maintenance dose for 7±2 days
91653|NCT02016170|P1|Participant Flow|Ticagrelor 180mg|Patients on prasugrel will switch to ticagrelor with a 180mg loading dose followed by 90 mg BID maintenance dose for 7±2 days.
91654|NCT02016170|O2|Outcome|Prasugrel|Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7 days
91655|NCT02016170|O1|Outcome|Ticagrelor|Patients switched to ticagrelor (two arms combined) with or without a loading dose and receiving ticagrelor 90 mg bid for 7 days.
91656|NCT02016170|O2|Outcome|Prasugrel|Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7 days
91657|NCT02016170|O1|Outcome|Ticagrelor|Patients switched to ticagrelor (two arms combined) with or without a loading dose and receiving ticagrelor 90 mg bid for 7 days.
91658|NCT02016170|E3|Reported Event|Prasugrel 10mg|Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7±2 days
91659|NCT02016170|E2|Reported Event|Ticagrelor 90mg|Patients on prasugrel will switch to ticagrelor with a 90mg maintenance dose followed by 90 mg BID maintenance dose for 7±2 days
91660|NCT02016170|E1|Reported Event|Ticagrelor 180mg|Patients on prasugrel will switch to ticagrelor with a 180mg loading dose followed by 90 mg BID maintenance dose for 7±2 days.
91661|NCT02016105|B3|Baseline|Total|Total of all reporting groups
91662|NCT02016105|B2|Baseline|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
91663|NCT02016105|B1|Baseline|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
91664|NCT02016105|P6|Participant Flow|GP2017 Adalimumab Continued|GP2017 subcutaneous (s.c.) injection of 40mg study drug from Week 17 until Week 35 (Treatment Period 2) and from Week 35 until Week 51 (Extension Period).
91665|NCT02016105|P5|Participant Flow|GP2017 Adalimumab Switched|Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35) followed by GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).
91666|NCT02016105|P4|Participant Flow|Humira ® Adalimumab Continued|Humira ® subcutaneous (s.c.) injection of 40mg study drug from Week 17 until Week 35 (Treatment Period 2) and from Week 35 until Week 51 (Extension Period).
91667|NCT02016105|P3|Participant Flow|Humira ® Adalimumab Switched|Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35) followed by Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).
91668|NCT02016105|P2|Participant Flow|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
91669|NCT02016105|P1|Participant Flow|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
91670|NCT02016105|O4|Outcome|GP2017 Adalimumab Continued|GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
91692|NCT02016105|O2|Outcome|Humira ® Adalimumab Continued|Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
91671|NCT02016105|O3|Outcome|GP2017 Adalimumab Switched|"GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
91672|NCT02016105|O2|Outcome|Humira ® Adalimumab Continued|Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
91673|NCT02016105|O1|Outcome|Humira ® Adalimumab Switched|"Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
91674|NCT02016105|O2|Outcome|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
91675|NCT02016105|O1|Outcome|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
91676|NCT02016105|O4|Outcome|GP2017 Adalimumab Continued|GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
91677|NCT02016105|O3|Outcome|GP2017 Adalimumab Switched|"GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
91678|NCT02016105|O2|Outcome|Humira ® Adalimumab Continued|Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
91679|NCT02016105|O1|Outcome|Humira ® Adalimumab Switched|"Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
91680|NCT02016105|O4|Outcome|GP2017 Adalimumab Continued|GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
91681|NCT02016105|O3|Outcome|GP2017 Adalimumab Switched|"GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
91682|NCT02016105|O2|Outcome|Humira ® Adalimumab Continued|Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
91683|NCT02016105|O1|Outcome|Humira ® Adalimumab Switched|"Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
91684|NCT02016105|O2|Outcome|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
91685|NCT02016105|O1|Outcome|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
91686|NCT02016105|O4|Outcome|GP2017 Adalimumab Continued|GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
91687|NCT02016105|O3|Outcome|GP2017 Adalimumab Switched|"GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
91688|NCT02016105|O2|Outcome|Humira ® Adalimumab Continued|Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
91689|NCT02016105|O1|Outcome|Humira ® Adalimumab Switched|"Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
91690|NCT02016105|O4|Outcome|GP2017 Adalimumab Continued|GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
91691|NCT02016105|O3|Outcome|GP2017 Adalimumab Switched|"GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
91693|NCT02016105|O1|Outcome|Humira ® Adalimumab Switched|"Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
91694|NCT02016105|O2|Outcome|Humira ® Adalimumab|"Humira® Adalimumab as a subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.~Humira ® Adalimumab"
91695|NCT02016105|O1|Outcome|GP2017 Adalimumab|"Study arm with intervention being studied in the protocol. Adalimumab Solution for subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.~GP2017 Adalimumab"
91696|NCT02016105|O4|Outcome|GP2017 Adalimumab Continued|GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
91697|NCT02016105|O3|Outcome|GP2017 Adalimumab Switched|"GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
91698|NCT02016105|O2|Outcome|Humira ® Adalimumab Continued|Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
91699|NCT02016105|O1|Outcome|Humira ® Adalimumab Switched|"Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
91700|NCT02016105|O4|Outcome|GP2017 Adalimumab Continued|GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
91701|NCT02016105|O3|Outcome|GP2017 Adalimumab Switched|"GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
91702|NCT02016105|O2|Outcome|Humira ® Adalimumab Continued|Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
91703|NCT02016105|O1|Outcome|Humira ® Adalimumab Switched|"Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
91704|NCT02016105|O2|Outcome|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
91705|NCT02016105|O1|Outcome|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
91706|NCT02016105|O2|Outcome|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
91707|NCT02016105|O1|Outcome|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
91708|NCT02016105|O2|Outcome|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
91709|NCT02016105|O1|Outcome|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
91710|NCT02016105|O2|Outcome|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
91711|NCT02016105|O1|Outcome|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
91712|NCT02016105|E4|Reported Event|GP2017 Adalimumab Continued|GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
91713|NCT02016105|E3|Reported Event|GP2017 Adalimumab Switched|"GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
91714|NCT02016105|E2|Reported Event|Humira ® Adalimumab Continued|Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
91799|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
91715|NCT02016105|E1|Reported Event|Humira ® Adalimumab Switched|"Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
91716|NCT02015910|B3|Baseline|Total|Total of all reporting groups
91717|NCT02015910|B2|Baseline|Placebo|"Placebo~Placebo: Sugar pill manufactured to mimick Sitagliptin 100mg pill."
91718|NCT02015910|B1|Baseline|Januvia (Sitagliptin)|"Sitagliptin 100 mg a day for 12 weeks~Sitagliptin: Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator"
91719|NCT02015910|P2|Participant Flow|Placebo|"Placebo~Placebo: Sugar pill manufactured to mimick Sitagliptin 100mg pill."
91720|NCT02015910|P1|Participant Flow|Januvia (Sitagliptin)|"Sitagliptin 100 mg a day for 12 weeks~Sitagliptin: Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator"
91721|NCT02015910|O2|Outcome|Placebo|"Placebo~Placebo: Sugar pill manufactured to mimick Sitagliptin 100mg pill."
91722|NCT02015910|O1|Outcome|Januvia (Sitagliptin)|"Sitagliptin 100 mg a day for 12 weeks~Sitagliptin: Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator"
91723|NCT02015910|E2|Reported Event|Placebo|"Placebo~Placebo: Sugar pill manufactured to mimick Sitagliptin 100mg pill."
91724|NCT02015910|E1|Reported Event|Januvia (Sitagliptin)|"Sitagliptin 100 mg a day for 12 weeks~Sitagliptin: Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator"
91725|NCT02015793|B3|Baseline|Total|Total of all reporting groups
91726|NCT02015793|B2|Baseline|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
91727|NCT02015793|B1|Baseline|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
91728|NCT02015793|P2|Participant Flow|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
91729|NCT02015793|P1|Participant Flow|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
91730|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
91731|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
91732|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
91733|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
91734|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
91735|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
91736|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
91737|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
91738|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
91739|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
91740|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
91741|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
91742|NCT02015793|O4|Outcome|Standard Induction Dose (Open-label Extension)|Participants received open-label adalimumab 40 mg every other week for 18 weeks.
91743|NCT02015793|O3|Outcome|Low Induction Dose (Open-label Extension Period)|Participants received open-label adalimumab 40 mg every other week for 18 weeks.
91744|NCT02015793|O2|Outcome|Standard Induction Dose (Double-blind Period)|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
91745|NCT02015793|O1|Outcome|Low Induction Dose (Double-blind Period)|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
91746|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
91747|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
91748|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
91749|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
91750|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
91751|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
91752|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
91753|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
91754|NCT02015793|E4|Reported Event|Standard Induction Dose (Open-label Extension)|Participants received open-label adalimumab 40 mg every other week for 18 weeks.
91755|NCT02015793|E3|Reported Event|Low Induction Dose (Open-label Extension)|Participants received open-label adalimumab 40 mg every other week for 18 weeks.
91756|NCT02015793|E2|Reported Event|Standard Induction Dose (Double-blind)|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
91757|NCT02015793|E1|Reported Event|Low Induction Dose (Double-blind)|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
91758|NCT02015754|B1|Baseline|DEBIRI|"DEBIRI: Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor.~LC Bead M1: The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer.~TACE: TACE a minimally invasive procedure performed to restrict a tumor's blood supply."
91759|NCT02015754|P1|Participant Flow|DEBIRI|"DEBIRI: Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor.~LC Bead M1: The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer.~TACE: TACE a minimally invasive procedure performed to restrict a tumor's blood supply."
91760|NCT02015754|O1|Outcome|DEBIRI|"DEBIRI: Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor.~LC Bead M1: The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer.~TACE: TACE a minimally invasive procedure performed to restrict a tumor's blood supply."
91761|NCT02015754|O1|Outcome|DEBIRI|"DEBIRI: Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor.~LC Bead M1: The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer.~TACE: TACE a minimally invasive procedure performed to restrict a tumor's blood supply."
91762|NCT02015754|O1|Outcome|DEBIRI|"DEBIRI: Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor.~LC Bead M1: The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer.~TACE: TACE a minimally invasive procedure performed to restrict a tumor's blood supply."
91763|NCT02015754|O1|Outcome|DEBIRI|"DEBIRI: Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor.~LC Bead M1: The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer.~TACE: TACE a minimally invasive procedure performed to restrict a tumor's blood supply."
91764|NCT02015754|O1|Outcome|DEBIRI|"DEBIRI: Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor.~LC Bead M1: The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer.~TACE: TACE a minimally invasive procedure performed to restrict a tumor's blood supply."
91765|NCT02015754|O1|Outcome|DEBIRI|"DEBIRI: Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor.~LC Bead M1: The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer.~TACE: TACE a minimally invasive procedure performed to restrict a tumor's blood supply."
91766|NCT02015754|O1|Outcome|DEBIRI|"DEBIRI: Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor.~LC Bead M1: The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer.~TACE: TACE a minimally invasive procedure performed to restrict a tumor's blood supply."
91800|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
91801|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
91767|NCT02015754|O1|Outcome|DEBIRI|"DEBIRI: Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor.~LC Bead M1: The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer.~TACE: TACE a minimally invasive procedure performed to restrict a tumor's blood supply."
91768|NCT02015754|O1|Outcome|DEBIRI|"DEBIRI: Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor.~LC Bead M1: The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer.~TACE: TACE a minimally invasive procedure performed to restrict a tumor's blood supply."
91769|NCT02015754|O1|Outcome|DEBIRI|"DEBIRI: Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor.~LC Bead M1: The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer.~TACE: TACE a minimally invasive procedure performed to restrict a tumor's blood supply."
91770|NCT02015754|O1|Outcome|DEBIRI|"DEBIRI: Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor.~LC Bead M1: The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer.~TACE: TACE a minimally invasive procedure performed to restrict a tumor's blood supply."
91771|NCT02015754|O1|Outcome|DEBIRI|"DEBIRI: Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor.~LC Bead M1: The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer.~TACE: TACE a minimally invasive procedure performed to restrict a tumor's blood supply."
91772|NCT02015754|O1|Outcome|DEBIRI|"DEBIRI: Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor.~LC Bead M1: The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer.~TACE: TACE a minimally invasive procedure performed to restrict a tumor's blood supply."
91773|NCT02015754|O1|Outcome|DEBIRI|"DEBIRI: Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor.~LC Bead M1: The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer.~TACE: TACE a minimally invasive procedure performed to restrict a tumor's blood supply."
91774|NCT02015754|E1|Reported Event|DEBIRI|"DEBIRI: Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor.~LC Bead M1: The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer.~TACE: TACE a minimally invasive procedure performed to restrict a tumor's blood supply."
91775|NCT02015676|B4|Baseline|Total|Total of all reporting groups
91776|NCT02015676|B3|Baseline|Trastuzumab, Doxorubicin, Paclitaxel; Phase II and II|During Phase I, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg/m^2, IV, once every 3 weeks, for 2 treatment cycles, then the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m^2, IV, once per week, starting at Week 19 for 2 treatment cycles, then the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression. In Phase II, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
91777|NCT02015676|B2|Baseline|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
91778|NCT02015676|B1|Baseline|Trastuzumab, Doxorubicin, Paclitaxel; Phase I|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg/m^2, IV, once every 3 weeks, from Week 1. If no DLT was observed in ≥2/3 of cohort for 2 treatment cycles, the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m^2, IV, once per week, starting at Week 19; if no DLT was observed in ≥2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression.
91779|NCT02015676|P3|Participant Flow|Trastuzumab Doxorubicin, Paclitaxel; Phase I and Phase II|During Phase I, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg/m^2, IV, once every 3 weeks, for 2 treatment cycles, then the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m^2, IV, once per week, starting at Week 19 for 2 treatment cycles, then the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression. In Phase II, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
91780|NCT02015676|P2|Participant Flow|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
91781|NCT02015676|P1|Participant Flow|Trastuzumab, Doxorubicin, Paclitaxel; Phase I|Participants received an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg per square meter (mg/m^2), IV, once every 3 weeks, from Week 1. If no dose-limiting toxicity (DLT) was observed in greater than or equal to (≥) two-thirds (2/3) of cohort for 2 treatment cycles, the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m^2, IV, once per week, starting at Week 19; if no DLT was observed in ≥2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression.
91782|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
91783|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
91784|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
91785|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
91786|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
91787|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
91788|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
91789|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
91790|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
91791|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
91792|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
91793|NCT02015676|E1|Reported Event|Trastuzumab, Doxorubicin, Paclitaxel; Phase I & II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
91794|NCT02015663|B3|Baseline|Total|Total of all reporting groups
91795|NCT02015663|B2|Baseline|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
91796|NCT02015663|B1|Baseline|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
91797|NCT02015663|P2|Participant Flow|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
91798|NCT02015663|P1|Participant Flow|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
91803|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
91804|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
91805|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
91806|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
91807|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
91808|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
91809|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
91810|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
91811|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
91812|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
91813|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
91814|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
91815|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
91816|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
91817|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
91818|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
91819|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
91820|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
91821|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
91822|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
91823|NCT02015663|E3|Reported Event|Total Events|
91824|NCT02015663|E2|Reported Event|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
91825|NCT02015663|E1|Reported Event|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
91826|NCT02015637|B3|Baseline|Total|Total of all reporting groups
91827|NCT02015637|B2|Baseline|Ceftriaxone|"Ceftriaxone 250 mg intramuscular injection administered once~Ceftriaxone: single dose"
91828|NCT02015637|B1|Baseline|Delafloxacin|"900mg orally (2 x 450 mg tablets) administered once~Delafloxacin: single dose"
91829|NCT02015637|P2|Participant Flow|Ceftriaxone|"Ceftriaxone 250 mg intramuscular injection administered once~Ceftriaxone: single dose"
91830|NCT02015637|P1|Participant Flow|Delafloxacin|"900mg orally (2 x 450 mg tablets) administered once~Delafloxacin: single dose"
91831|NCT02015637|O2|Outcome|Ceftriaxone|"Ceftriaxone 250 mg intramuscular injection administered once~Ceftriaxone: single dose"
91832|NCT02015637|O1|Outcome|Delafloxacin|"900mg orally (2 x 450 mg tablets) administered once~Delafloxacin: single dose"
91833|NCT02015637|O2|Outcome|Ceftriaxone|"Ceftriaxone 250 mg intramuscular injection administered once~Ceftriaxone: single dose"
91834|NCT02015637|O1|Outcome|Delafloxacin|"900mg orally (2 x 450 mg tablets) administered once~Delafloxacin: single dose"
91835|NCT02015637|E2|Reported Event|Ceftriaxone|"Ceftriaxone 250 mg intramuscular injection administered once~Ceftriaxone: single dose"
91836|NCT02015637|E1|Reported Event|Delafloxacin|"900mg orally (2 x 450 mg tablets) administered once~Delafloxacin: single dose"
91837|NCT02015546|B4|Baseline|Total|Total of all reporting groups
91838|NCT02015546|B3|Baseline|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91839|NCT02015546|B2|Baseline|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91840|NCT02015546|B1|Baseline|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91841|NCT02015546|P3|Participant Flow|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91842|NCT02015546|P2|Participant Flow|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91843|NCT02015546|P1|Participant Flow|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91844|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91845|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91846|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91847|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91848|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91849|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91850|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91851|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91852|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91853|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91854|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91855|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91856|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91857|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91858|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91859|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91860|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91861|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91862|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91863|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91864|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91865|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91866|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91867|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91868|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91869|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91870|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91871|NCT02015546|E3|Reported Event|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91872|NCT02015546|E2|Reported Event|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91873|NCT02015546|E1|Reported Event|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
91874|NCT02015481|B1|Baseline|Cabaletta 30gr.|"weekly IV of Cabaletta 30gr.~Cabaletta"
91875|NCT02015481|P1|Participant Flow|Cabaletta 30gr|"weekly IV of Cabaletta 30gr~Cabaletta"
91876|NCT02015481|O1|Outcome|Cabaletta 30gr|"weekly IV of Cabaletta 30gr~Cabaletta"
91877|NCT02015481|O1|Outcome|Cabaletta 30gr|"weekly IV of Cabaletta 30gr~Cabaletta"
91878|NCT02015481|O1|Outcome|Cabaletta 30gr|"weekly IV of Cabaletta 30gr~Cabaletta"
91879|NCT02015481|O1|Outcome|Cabaletta 30gr.|"weekly IV of Cabaletta 30gr.~Cabaletta"
91880|NCT02015481|E1|Reported Event|Cabaletta 30gr|"weekly IV of Cabaletta 30gr~Cabaletta"
91881|NCT02015234|B3|Baseline|Total|Total of all reporting groups
91882|NCT02015234|B2|Baseline|TNX-102 SL 2.8 mg - TNX-102 SL 2.8 mg|"1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 12 months~TNX-102 SL: TNX-102 2.8 mg SL taken daily at bedtime."
91883|NCT02015234|B1|Baseline|Placebo - TNX-102 SL 2.8 mg|"1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 12 months~TNX-102 SL: TNX-102 2.8 mg SL taken daily at bedtime."
91884|NCT02015234|P2|Participant Flow|TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg|These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202) as well as the open-label study, for a total treatment duration of up to 15 months.
94257|NCT02005211|O3|Outcome|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
91885|NCT02015234|P1|Participant Flow|Placebo - TNX-102 SL 2.8 mg|These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study.
91886|NCT02015234|O2|Outcome|TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg|These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202), as well as the open-label study, for a total treatment duration of up to 15 months.
91887|NCT02015234|O1|Outcome|Placebo - TNX-102 SL 2.8 mg|These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study.
91888|NCT02015234|O2|Outcome|TNX-102 SL 2.8 mg - TNX-102 SL 2.8 mg|These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202), as well as the open-label study, for a total treatment duration of up to 15 months.
91889|NCT02015234|O1|Outcome|Placebo - TNX-102 SL 2.8 mg|These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study.
91890|NCT02015234|O2|Outcome|TNX-102 SL 2.8 mg - TNX-102 SL 2.8 mg|These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202), as well as the open-label study, for a total treatment duration of up to 15 months.
91891|NCT02015234|O1|Outcome|Placebo - TNX-102 SL 2.8 mg|These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study.
91892|NCT02015234|O2|Outcome|TNX-102 SL 2.8 mg - TNX-102 SL 2.8 mg|These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202) as well as the open-label study, for a total treatment duration of up to 15 months.
91893|NCT02015234|O1|Outcome|Placebo - TNX-102 SL 2.8 mg|These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study.
91894|NCT02015234|E2|Reported Event|TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg|These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202), as well as the open-label study, for a total treatment duration of up to 15 months.
91895|NCT02015234|E1|Reported Event|Placebo - TNX-102 SL 2.8 mg|These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study.
91896|NCT02015221|B3|Baseline|Total|Total of all reporting groups
91897|NCT02015221|B2|Baseline|Standard Compression Garments|Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.
91898|NCT02015221|B1|Baseline|ACTitouch|ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.
91899|NCT02015221|P2|Participant Flow|Standard Compression Garments|"Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.~Standard Compression Garments: Compression stockings with a 30-40mmHg level of compression."
91900|NCT02015221|P1|Participant Flow|ACTitouch|"ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.~Dual Action Pneumatic Compression Device: A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet."
91901|NCT02015221|O2|Outcome|Standard Compression Garments|"Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.~Standard Compression Garments: Compression stockings with a 30-40mmHg level of compression."
91902|NCT02015221|O1|Outcome|ACTitouch|"ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.~Dual Action Pneumatic Compression Device: A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet."
91903|NCT02015221|E2|Reported Event|Standard Compression Garments|"Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.~Standard Compression Garments: Compression stockings with a 30-40mmHg level of compression."
91904|NCT02015221|E1|Reported Event|ACTitouch|"ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.~Dual Action Pneumatic Compression Device: A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet."
91905|NCT02015195|B8|Baseline|Total|Total of all reporting groups
91906|NCT02015195|B7|Baseline|Heated Water (40 Degrees Celsius)|"Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Heated Tap Water (40 degrees Celsius)~No treatment~8 males, 8 females treated"
91907|NCT02015195|B6|Baseline|Isopropyl Alcohol (70%)|"Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Isopropyl Alcohol (70%)~No treatment~8 makes, 8 females treated"
91908|NCT02015195|B5|Baseline|Lidocaine (4%)|"Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Lidocaine (4%)~No treatment~10 males, 6 females treated"
91909|NCT02015195|B4|Baseline|Household Ammonia (10%)|"Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Ammonia (10%)~No treatment~1 female treated; adverse local skin reaction; study arm therefore withdrawn"
91910|NCT02015195|B3|Baseline|Papain Slurry (70%)|"Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Papain Slurry (70%)~No treatment~9 males, 7 females treated"
91911|NCT02015195|B2|Baseline|Sodium Bicarbonate Slurry (50%)|"Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Sodium Bicarbonate Slurry (50%)~No treatment~8 males, 8 females treated"
91912|NCT02015195|B1|Baseline|Acetic Acid 5%|"Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Acetic Acid (5%)~No treatment~11 males, 5 females treated"
92037|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
94258|NCT02005211|O2|Outcome|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
91913|NCT02015195|P7|Participant Flow|Hot Water (40 Degrees Celsius)|"Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Hot Tap Water (40 degrees Celsius)~No treatment~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
91914|NCT02015195|P6|Participant Flow|Isopropyl Alcohol (70%)|"Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Isopropyl Alcohol (70%)~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment).~No treatment"
91915|NCT02015195|P5|Participant Flow|Lidocaine (4%)|"Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Lidocaine (4%)~No treatment~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
91916|NCT02015195|P4|Participant Flow|Household Ammonia (10%)|"Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Ammonia (10%)~No treatment~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
91917|NCT02015195|P3|Participant Flow|Papain Slurry (70%)|"Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Papain Slurry (70%)~No treatment~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
91918|NCT02015195|P2|Participant Flow|Sodium Bicarbonate Slurry (50%)|"Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Sodium Bicarbonate Slurry (50%)~No treatment~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
91919|NCT02015195|P1|Participant Flow|Acetic Acid 5%|"Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Acetic Acid (5%)~No treatment~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
91920|NCT02015195|O6|Outcome|Hot Water (40 Degrees Celsius)|"Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Hot Tap Water (40 degrees Celsius)~No treatment"
91921|NCT02015195|O5|Outcome|Isopropyl Alcohol (70%)|"Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Isopropyl Alcohol (70%)~No treatment"
91922|NCT02015195|O4|Outcome|Lidocaine (4%)|"Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Lidocaine (4%)~No treatment"
91923|NCT02015195|O3|Outcome|Papain Slurry (70%)|"Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Papain Slurry (70%)~No treatment"
91924|NCT02015195|O2|Outcome|Sodium Bicarbonate Slurry (50%)|"Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Sodium Bicarbonate Slurry (50%)~No treatment"
91925|NCT02015195|O1|Outcome|Acetic Acid 5%|"Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Acetic Acid (5%)~No treatment"
91926|NCT02015195|O6|Outcome|Hot Water (40 Degrees Celsius)|"Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Hot Tap Water (40 degrees Celsius)~No treatment"
91927|NCT02015195|O5|Outcome|Isopropyl Alcohol (70%)|"Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Isopropyl Alcohol (70%)~No treatment"
91928|NCT02015195|O4|Outcome|Lidocaine (4%)|"Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Lidocaine (4%)~No treatment"
91929|NCT02015195|O3|Outcome|Papain Slurry (70%)|"Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Papain Slurry (70%)~No treatment"
91930|NCT02015195|O2|Outcome|Sodium Bicarbonate Slurry (50%)|"Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Sodium Bicarbonate Slurry (50%)~No treatment"
91931|NCT02015195|O1|Outcome|Acetic Acid 5%|"Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Acetic Acid (5%)~No treatment"
91932|NCT02015195|E7|Reported Event|Hot Water (40 Degrees Celsius)|"Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Hot Tap Water (40 degrees Celsius)~No treatment"
91933|NCT02015195|E6|Reported Event|Isopropyl Alcohol (70%)|"Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Isopropyl Alcohol (70%)~No treatment"
91934|NCT02015195|E5|Reported Event|Lidocaine (4%)|"Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Lidocaine (4%)~No treatment"
91935|NCT02015195|E4|Reported Event|Household Ammonia (10%)|"Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Ammonia (10%)~No treatment~The first patient treated had an adverse local skin reaction, so this study arm was discontinued"
91936|NCT02015195|E3|Reported Event|Papain Slurry (70%)|"Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Papain Slurry (70%)~No treatment"
91937|NCT02015195|E2|Reported Event|Sodium Bicarbonate Slurry (50%)|"Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Sodium Bicarbonate Slurry (50%)~No treatment"
91938|NCT02015195|E1|Reported Event|Acetic Acid 5%|"Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Acetic Acid (5%)~No treatment"
91939|NCT02015039|B3|Baseline|Total|Total of all reporting groups
91940|NCT02015039|B2|Baseline|Botulinum Toxin Therapy Plus Occupational Therapy|Patients with writer's cramp receive botulinum toxin therapy plus occupational therapy. Patients in this group receive botulinum toxin injections and 10 minutes of daily writing. This group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection and occupational therapy instruction. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
92122|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
91941|NCT02015039|B1|Baseline|Botulinum Toxin Therapy Only|Patients with writer's cramp receive botulinum toxin therapy only. Patients in this group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
91942|NCT02015039|P2|Participant Flow|Botulinum Toxin Therapy Plus Occupational Therapy|Patients with writer's cramp receive botulinum toxin therapy plus occupational therapy. Patients in this group receive botulinum toxin injections and 10 minutes of daily writing. This group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection and occupational therapy instruction. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
91943|NCT02015039|P1|Participant Flow|Botulinum Toxin Therapy Only|Patients with writer's cramp receive botulinum toxin therapy only. Patients in this group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
91944|NCT02015039|O2|Outcome|Botulinum Toxin Therapy Plus Occupational Therapy|Patients with writer's cramp receive botulinum toxin therapy plus occupational therapy. Patients in this group receive botulinum toxin injections and 10 minutes of daily writing. This group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection and occupational therapy instruction. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
91945|NCT02015039|O1|Outcome|Botulinum Toxin Therapy Only|Patients with writer's cramp receive botulinum toxin therapy only. Patients in this group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
91946|NCT02015039|O2|Outcome|Botulinum Toxin Therapy Plus Occupational Therapy|Patients with writer's cramp receive botulinum toxin therapy plus occupational therapy. Patients in this group receive botulinum toxin injections and 10 minutes of daily writing. This group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection and occupational therapy instruction. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
91947|NCT02015039|O1|Outcome|Botulinum Toxin Therapy Only|Patients with writer's cramp receive botulinum toxin therapy only. Patients in this group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
91948|NCT02015039|O2|Outcome|Botulinum Toxin Therapy Plus Occupational Therapy|Patients with writer's cramp receive botulinum toxin therapy plus occupational therapy. Patients in this group receive botulinum toxin injections and 10 minutes of daily writing. This group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection and occupational therapy instruction. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
91949|NCT02015039|O1|Outcome|Botulinum Toxin Therapy Only|Patients with writer's cramp receive botulinum toxin therapy only. Patients in this group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
91950|NCT02015039|O2|Outcome|Botulinum Toxin Therapy Plus Occupational Therapy|Patients with writer's cramp receive botulinum toxin therapy plus occupational therapy. Patients in this group receive botulinum toxin injections and 10 minutes of daily writing. This group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection and occupational therapy instruction. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
91951|NCT02015039|O1|Outcome|Botulinum Toxin Therapy Only|Patients with writer's cramp receive botulinum toxin therapy only. Patients in this group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
91952|NCT02015039|O2|Outcome|Botulinum Toxin Therapy Plus Occupational Therapy|Patients with writer's cramp receive botulinum toxin therapy plus occupational therapy. Patients in this group receive botulinum toxin injections and 10 minutes of daily writing. This group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection and occupational therapy instruction. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
91953|NCT02015039|O1|Outcome|Botulinum Toxin Therapy Only|Patients with writer's cramp receive botulinum toxin therapy only. Patients in this group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
91954|NCT02015039|O2|Outcome|Botulinum Toxin Therapy Plus Occupational Therapy|Patients with writer's cramp receive botulinum toxin therapy plus occupational therapy. Patients in this group receive botulinum toxin injections and 10 minutes of daily writing. This group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection and occupational therapy instruction. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
91955|NCT02015039|O1|Outcome|Botulinum Toxin Therapy Only|Patients with writer's cramp receive botulinum toxin therapy only. Patients in this group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
92228|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
91956|NCT02015039|O2|Outcome|Botulinum Toxin Therapy Plus Occupational Therapy|Patients with writer's cramp receive botulinum toxin therapy plus occupational therapy. Patients in this group receive botulinum toxin injections and 10 minutes of daily writing. This group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection and occupational therapy instruction. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
91957|NCT02015039|O1|Outcome|Botulinum Toxin Therapy Only|Patients with writer's cramp receive botulinum toxin therapy only. Patients in this group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
91958|NCT02015039|E2|Reported Event|Botulinum Toxin Therapy Plus Occupational Therapy|Patients with writer's cramp receive botulinum toxin therapy plus occupational therapy. Patients in this group receive botulinum toxin injections and 10 minutes of daily writing. This group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection and occupational therapy instruction. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
91959|NCT02015039|E1|Reported Event|Botulinum Toxin Therapy Only|Patients with writer's cramp receive botulinum toxin therapy only. Patients in this group will be seen for 9 visits during a 24 week period, following their botulinum toxin injection. Visits 1-4 will be 1 week apart and visits 5-9 will be 4 weeks apart. Visits will entail hand grip assessment, video recording, and patient rated subjective severity scales.
91960|NCT02014740|B3|Baseline|Total|Total of all reporting groups
91961|NCT02014740|B2|Baseline|Metformin|"M-group will be treated with Metformin for the duration of the study. Metformin (from 500 mg twice daily to a maximum of 1000 mg twice daily) regimen will be continued to achieve fasting glucose between 80 and 140 mg/dl~Metformin"
91962|NCT02014740|B1|Baseline|Liraglutide|• L-group will be started and dose-escalated to 1.8mg sc once daily according to below schedule: Liraglutide will be administered with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). L-group subjects will need to achieve the final dose of 1.8 mg by at least three weeks from the starting dose. Subjects who would not be able to achieve the dose of 1.8 mg (due to potential side effects) will be advised to lower the dose to 1.2 mg. Metformin regimen will be continued.
91963|NCT02014740|P2|Participant Flow|Metformin|"M-group will be treated with Metformin for the duration of the study. Metformin (from 500 mg twice daily to a maximum of 1000 mg twice daily) regimen will be continued to achieve fasting glucose between 80 and 140 mg/dl~Metformin"
91964|NCT02014740|P1|Participant Flow|Liraglutide|L-group will be started and dose-escalated to 1.8mg sc once daily according to below schedule: Liraglutide will be administered with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). L-group subjects will need to achieve the final dose of 1.8 mg by at least three weeks from the starting dose. Subjects who would not be able to achieve the dose of 1.8 mg (due to potential side effects) will be advised to lower the dose to 1.2 mg. Metformin regimen will be continued.
91965|NCT02014740|O2|Outcome|Metformin|"M-group will be treated with Metformin for the duration of the study. Metformin (from 500 mg twice daily to a maximum of 1000 mg twice daily) regimen will be continued to achieve fasting glucose between 80 and 140 mg/dl~Metformin"
91966|NCT02014740|O1|Outcome|Liraglutide|• L-group will be started and dose-escalated to 1.8mg sc once daily according to below schedule: Liraglutide will be administered with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). L-group subjects will need to achieve the final dose of 1.8 mg by at least three weeks from the starting dose. Subjects who would not be able to achieve the dose of 1.8 mg (due to potential side effects) will be advised to lower the dose to 1.2 mg. Metformin regimen will be continued.
91967|NCT02014740|E2|Reported Event|Metformin|"M-group will be treated with Metformin for the duration of the study. Metformin (from 500 mg twice daily to a maximum of 1000 mg twice daily) regimen will be continued to achieve fasting glucose between 80 and 140 mg/dl~Metformin"
91968|NCT02014740|E1|Reported Event|Liraglutide|L-group will be started and dose-escalated to 1.8mg sc once daily according to below schedule: Liraglutide will be administered with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). L-group subjects will need to achieve the final dose of 1.8 mg by at least three weeks from the starting dose. Subjects who would not be able to achieve the dose of 1.8 mg (due to potential side effects) will be advised to lower the dose to 1.2 mg. Metformin regimen will be continued.
91969|NCT02014584|B3|Baseline|Total|Total of all reporting groups
91970|NCT02014584|B2|Baseline|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
91971|NCT02014584|B1|Baseline|Placebo|Participants received placebo administered orally once daily for 24 weeks.
91972|NCT02014584|P6|Participant Flow|Targeted F/U: Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|Participants with an ongoing AE related to sexual function at the end of the treatment Period and participants who discontinued study treatment due to an AE related to sexual function entered a Targeted Follow-Up Period (no study drug administered) lasting until 24 weeks after the last dose of study treatment or until resolution of the sexual AE, whichever occurred first.
91973|NCT02014584|P5|Participant Flow|Targeted F/U: Placebo (DB)/Dutasteride 0.5 mg (OL)|Participants with an ongoing AE related to sexual function at the end of the treatment Period and participants who discontinued study treatment due to an AE related to sexual function entered a Targeted Follow-Up Period (no study treatment administered) lasting until 24 weeks after the last dose of study treatment or until resolution of the sexual AE, whichever occurred first.
91974|NCT02014584|P4|Participant Flow|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92264|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
91975|NCT02014584|P3|Participant Flow|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
91976|NCT02014584|P2|Participant Flow|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
91977|NCT02014584|P1|Participant Flow|Placebo|Participants received placebo administered orally once daily for 24 weeks.
91978|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
91979|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
91980|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
91981|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
91982|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
91983|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
91984|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
91985|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
91986|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
91987|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
91988|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
91989|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
91990|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
91991|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
91992|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
91993|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
91994|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
91995|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
91996|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
91997|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
91998|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
91999|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
92000|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
92001|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
92002|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92003|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
92004|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
92005|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
94259|NCT02005211|O1|Outcome|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
92006|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92007|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
92008|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
92009|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
92010|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92011|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
92012|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
92013|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
92014|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92015|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
92016|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
92017|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
92018|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92019|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
92020|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
92021|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
92022|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92023|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
92024|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
92025|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
92026|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92027|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
92028|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
92029|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
92030|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92031|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
92032|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
92033|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
92034|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92035|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
92038|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92039|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
92040|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
92041|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
92042|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92043|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
92044|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
92045|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
92046|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92047|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
92048|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
92049|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
92050|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92051|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
92052|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
92053|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
92054|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92055|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
92056|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
92057|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
92058|NCT02014584|O1|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92059|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92060|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
92061|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
92062|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
92063|NCT02014584|O1|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92064|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92065|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
92066|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
92067|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
92068|NCT02014584|O1|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92069|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92070|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
92071|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
92072|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
92073|NCT02014584|O1|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92074|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92075|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
92076|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
92077|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
92078|NCT02014584|O1|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92079|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92080|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
92081|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
92082|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
92083|NCT02014584|O1|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92084|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
92085|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
92086|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
92087|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
92088|NCT02014584|E5|Reported Event|Combined: Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|
92089|NCT02014584|E4|Reported Event|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|
92090|NCT02014584|E3|Reported Event|Placebo (DB)/Dutasteride 0.5 mg (OL)|
92091|NCT02014584|E2|Reported Event|Dutasteride 0.5 mg (DB)|
92092|NCT02014584|E1|Reported Event|Placebo (DB)|
92093|NCT02014480|B1|Baseline|UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg|All participants received one of the following three treatments in one of three treatment periods QD from the DPI for 14 days: UMEC 62.5 µg inhalation powder; VI 25 µg inhalation powder; and UMEC/VI 62.5/25 µg inhalation powder. Participants were randomized to receive treatment in one of the six following sequences: (1) UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg; (2) VI 25 µg, UMEC/VI 62.5/25 µg, UMEC 62.5 µg; (3) UMEC/VI 62.5/25 µg, UMEC 62.5 µg, VI 25 µg; (4) UMEC 62.5 µg, UMEC/VI 62.5/25 µg, VI 25 µg; (5) VI 25 µg, UMEC 62.5 µg, UMEC/VI 62.5/25 µg; (6) UMEC/VI 62.5/25 µg, VI 25 µg, UMEC 62.5 µg. The three treatment periods were separated by a washout period of 10 to 14 days.
92094|NCT02014480|P6|Participant Flow|Sequence 6: UMEC/VI 62.5/25 µg, VI 25 µg, UMEC 62.5 µg|Participants received UMEC/VI 62.5/25 µg, VI 25 µg, and UMEC 62.5 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
92095|NCT02014480|P5|Participant Flow|Sequence 5: VI 25 µg, UMEC 62.5 µg, UMEC/VI 62.5/25 µg|Participants received VI 25 µg, UMEC 62.5 µg, and UMEC/VI 62.5/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
92401|NCT02013791|E7|Reported Event|Stage 1 Cohort 6D|Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
92096|NCT02014480|P4|Participant Flow|Sequence 4: UMEC 62.5 µg, UMEC/VI 62.5/25 µg, VI 25 µg|Participants received UMEC 62.5 µg, UMEC/VI 62.5/25 µg, and VI 25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
92097|NCT02014480|P3|Participant Flow|Sequence 3: UMEC/VI 62.5/25 µg, UMEC 62.5 µg, VI 25 µg|Participants received UMEC/VI 62.5/25 µg, UMEC 62.5 µg, and VI 25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
92098|NCT02014480|P2|Participant Flow|Sequence 2: VI 25 µg, UMEC/VI 62.5/25 µg, UMEC 62.5 µg|Participants received VI 25 µg, UMEC/VI 62.5/25 µg, and UMEC 62.5 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
92099|NCT02014480|P1|Participant Flow|Sequence 1: UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg|Participants received umeclidinium (UMEC) 62.5 micrograms (µg), vilanterol trifenatate (VI) 25 µg, and UMEC/VI 62.5/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day (QD) for 14 days from a Dry Powder Inhaler (DPI). The three treatment periods were separated by a washout period of 10 to 14 days.
92100|NCT02014480|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
92101|NCT02014480|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
92102|NCT02014480|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
92103|NCT02014480|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
92104|NCT02014480|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
92105|NCT02014480|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
92106|NCT02014480|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
92107|NCT02014480|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
92108|NCT02014480|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
92109|NCT02014480|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
92110|NCT02014480|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
92111|NCT02014480|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
92112|NCT02014480|E3|Reported Event|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
92113|NCT02014480|E2|Reported Event|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
92114|NCT02014480|E1|Reported Event|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
92115|NCT02014467|B3|Baseline|Total|Total of all reporting groups
92116|NCT02014467|B2|Baseline|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92117|NCT02014467|B1|Baseline|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92118|NCT02014467|P2|Participant Flow|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase.Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92119|NCT02014467|P1|Participant Flow|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92120|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92121|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
94260|NCT02005211|O7|Outcome|Placebo Part 2|Placebo Part 2 - MAD
92123|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92124|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92125|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92126|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92127|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92128|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92129|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92130|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92131|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92132|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92133|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92134|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92135|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92136|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92137|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92138|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92139|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92140|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92141|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92142|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92143|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92144|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92145|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
94261|NCT02005211|O6|Outcome|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
92146|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92147|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92148|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92149|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92150|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92151|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92152|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92153|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92154|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92155|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92156|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92157|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92158|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92159|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92160|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92161|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92162|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92163|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92164|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92165|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92166|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92167|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92168|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92458|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
92169|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92170|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92171|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92172|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92173|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92174|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92175|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92176|NCT02014467|E2|Reported Event|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
92177|NCT02014467|E1|Reported Event|Denosumab 60mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
92178|NCT02014441|B1|Baseline|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92179|NCT02014441|P1|Participant Flow|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92180|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92181|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92182|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92183|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92184|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92185|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92186|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92187|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92188|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92189|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
92190|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92191|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92192|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
92402|NCT02013791|E6|Reported Event|Stage 1 Cohort 6B|Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1.
92193|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92194|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92195|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
92196|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92197|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92198|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
92199|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92200|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92201|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
92202|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92203|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92204|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
92205|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92206|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92207|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
92208|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92209|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92210|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
92211|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92212|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92213|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
92214|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92215|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92216|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
92217|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92218|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92219|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
92220|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92221|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92222|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
92223|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92224|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92225|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
92226|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92227|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92229|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92230|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92231|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
92232|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92233|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92234|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
92235|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92236|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92237|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
92238|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92239|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92240|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
92241|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92242|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92243|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
92244|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92245|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92246|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
92247|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92248|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92249|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
92250|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92251|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92252|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
92253|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92254|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92255|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
92256|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92257|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92258|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
92259|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92260|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92261|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
92262|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92263|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92265|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92266|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
92267|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
92268|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92269|NCT02014441|E1|Reported Event|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
92270|NCT02014402|B5|Baseline|Total|Total of all reporting groups
92271|NCT02014402|B4|Baseline|IG1202-D (Spinal)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
92272|NCT02014402|B3|Baseline|IG1202-C (Soft Tissue)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
92273|NCT02014402|B2|Baseline|IG1202-B (Hepatic)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
92274|NCT02014402|B1|Baseline|IG1202-A (Vascular)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
92275|NCT02014402|P4|Participant Flow|IG1202-D (Spinal)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
92276|NCT02014402|P3|Participant Flow|IG1202-C (Soft Tissue)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
92277|NCT02014402|P2|Participant Flow|IG1202-B (Hepatic)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
92278|NCT02014402|P1|Participant Flow|IG1202-A (Vascular)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
92279|NCT02014402|O5|Outcome|Overall (IG1202-A, IG1202-B, IG1202-C, and IG1202-D)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
92280|NCT02014402|O4|Outcome|IG1202-D (Spinal)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
92281|NCT02014402|O3|Outcome|IG1202-C (Soft Tissue)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
92282|NCT02014402|O2|Outcome|IG1202-B (Hepatic)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
92283|NCT02014402|O1|Outcome|IG1202-A (Vascular)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
92284|NCT02014402|O5|Outcome|Overall (IG1202-A, IG1202-B, IG1202-C, and IG1202-D)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
92285|NCT02014402|O4|Outcome|IG1202-D (Spinal)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
92286|NCT02014402|O3|Outcome|IG1202-C (Soft Tissue)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
92287|NCT02014402|O2|Outcome|IG1202-B (Hepatic)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
92403|NCT02013791|E5|Reported Event|Stage 1 Cohort 2|Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1.
92288|NCT02014402|O1|Outcome|IG1202-A (Vascular)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
92289|NCT02014402|O5|Outcome|Overall (IG1202-A, IG1202-B, IG1202-C, and IG1202-D)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
92290|NCT02014402|O4|Outcome|IG1202-D (Spinal)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
92291|NCT02014402|O3|Outcome|IG1202-C (Soft Tissue)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
92292|NCT02014402|O2|Outcome|IG1202-B (Hepatic)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
92293|NCT02014402|O1|Outcome|IG1202-A (Vascular)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
92294|NCT02014402|E10|Reported Event|Overall (IG1202-A, -B, -C, and -D): Bovine Thrombin|Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
92295|NCT02014402|E9|Reported Event|Overall (IG1202-A, -B, -C, and -D): Human Thrombin|Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
92296|NCT02014402|E8|Reported Event|IG1202-D (Spinal): Bovine Thrombin|Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
92297|NCT02014402|E7|Reported Event|IG1202-D (Spinal): Human Thrombin|Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
92298|NCT02014402|E6|Reported Event|IG1202-C (Soft Tissue): Bovine Thrombin|Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
92299|NCT02014402|E5|Reported Event|IG1202-C (Soft Tissue): Human Thrombin|Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
92300|NCT02014402|E4|Reported Event|IG1202-B (Hepatic): Bovine Thrombin|Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
92301|NCT02014402|E3|Reported Event|IG1202-B (Hepatic): Human Thrombin|Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
92302|NCT02014402|E2|Reported Event|IG1202-A (Vascular): Bovine Thrombin|Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
92303|NCT02014402|E1|Reported Event|IG1202-A (Vascular): Human Thrombin|Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
92304|NCT02014363|B4|Baseline|Total|Total of all reporting groups
92305|NCT02014363|B3|Baseline|Amitriptyline|"Amitriptyline tablets (encapsulated) Standard dosing regime~Amitriptyline"
92306|NCT02014363|B2|Baseline|ETS6103 (High Dose)|"ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (high dose)"
92307|NCT02014363|B1|Baseline|ETS6103 (Low Dose)|"ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (low dose)"
92308|NCT02014363|P3|Participant Flow|Amitriptyline|"Amitriptyline tablets (encapsulated) Standard dosing regime~Amitriptyline"
92309|NCT02014363|P2|Participant Flow|ETS6103 (High Dose)|"ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (high dose)"
92310|NCT02014363|P1|Participant Flow|ETS6103 (Low Dose)|"ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (low dose)"
92311|NCT02014363|O3|Outcome|Amitriptyline|"Amitriptyline tablets (encapsulated) Standard dosing regime~Amitriptyline"
92312|NCT02014363|O2|Outcome|ETS6103 (High Dose)|"ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (high dose)"
92313|NCT02014363|O1|Outcome|ETS6103 (Low Dose)|"ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (low dose)"
92314|NCT02014363|E3|Reported Event|Amitriptyline|"Amitriptyline tablets (encapsulated) Standard dosing regime~Amitriptyline"
92315|NCT02014363|E2|Reported Event|ETS6103 (High Dose)|"ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (high dose)"
92316|NCT02014363|E1|Reported Event|ETS6103 (Low Dose)|"ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (low dose)"
92317|NCT02014272|B1|Baseline|Entire Study Population|Includes all participants randomized to receive RIN 150 first and rifampicin and isoniazid first.
92318|NCT02014272|P2|Participant Flow|Rifampicin and Isoniazid First, Then RIN 150|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in first intervention period followed by single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in second intervention period. A washout period of at least 7 days was maintained between each intervention period.
92319|NCT02014272|P1|Participant Flow|RIN 150 First, Then Rifampicin and Isoniazid|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contained 150 milligram [mg] rifampicin and 75 mg isoniazid) on Day 1 in first intervention period, followed by single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in second intervention period. A washout period of at least 7 days was maintained between each intervention period.
92320|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
92321|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
92322|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
92323|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
92324|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
92325|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
92326|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
92327|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
92328|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
92329|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
92330|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
92331|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
92332|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
92333|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
92334|NCT02014272|E2|Reported Event|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
92335|NCT02014272|E1|Reported Event|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
92336|NCT02014051|B1|Baseline|All Participants|All participants who received at least 1 dose of SyB C-1101 either at 280 mg/dose or 560 mg/dose orally.
92337|NCT02014051|P2|Participant Flow|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
92338|NCT02014051|P1|Participant Flow|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
92339|NCT02014051|O1|Outcome|All Participants|All participants who received at least 1 dose of SyB C-1101 either at 280 mg/dose or 560 mg/dose orally.
92340|NCT02014051|O2|Outcome|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
92341|NCT02014051|O1|Outcome|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
92342|NCT02014051|O2|Outcome|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
92343|NCT02014051|O1|Outcome|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
92344|NCT02014051|O2|Outcome|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
92459|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
92345|NCT02014051|O1|Outcome|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
92346|NCT02014051|O2|Outcome|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
92347|NCT02014051|O1|Outcome|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
92348|NCT02014051|E2|Reported Event|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
92349|NCT02014051|E1|Reported Event|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
92350|NCT02013830|B1|Baseline|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
92351|NCT02013830|P1|Participant Flow|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 milligrams per kilogram (mg/kg) bevacizumab intravenously (IV) on Day 1; and 1600 mg per square meter per day (mg/m^2/day) capecitabine tablets, orally (PO), in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
92352|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
92353|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
92354|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
92355|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
92356|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
92357|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
92404|NCT02013791|E4|Reported Event|Stage 1 Cohort 3|Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1.
92709|NCT02013050|O4|Outcome|6.0 mg/kg|
92710|NCT02013050|O3|Outcome|3.0 mg/kg|
92358|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
92359|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
92360|NCT02013830|E1|Reported Event|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
92361|NCT02013817|B1|Baseline|Rituximab, Fludarabine, Cyclophosphamide|Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4. Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5. Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years).
92362|NCT02013817|P1|Participant Flow|Rituximab, Fludarabine, Cyclophosphamide|Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 milligrams per square meter (mg/m^2) intravenously (IV) and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4. Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5. Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years).
92363|NCT02013817|O1|Outcome|Rituximab, Fludarabine, Cyclophosphamide|Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4. Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5. Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years).
92364|NCT02013817|O1|Outcome|Rituximab, Fludarabine, Cyclophosphamide|Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4. Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5. Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years).
92365|NCT02013817|O1|Outcome|Rituximab, Fludarabine, Cyclophosphamide|Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4. Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5. Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years).
92366|NCT02013817|O1|Outcome|Rituximab, Fludarabine, Cyclophosphamide|Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4. Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5. Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years).
92367|NCT02013817|O1|Outcome|Rituximab, Fludarabine, Cyclophosphamide|Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4. Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5. Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years).
92457|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
92711|NCT02013050|O2|Outcome|1.5 mg/kg|
92368|NCT02013817|O1|Outcome|Rituximab, Fludarabine, Cyclophosphamide|Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4. Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5. Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years).
92369|NCT02013817|E1|Reported Event|Rituximab, Fludarabine, Cyclophosphamide|Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4. Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5. Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years).
92370|NCT02013791|B10|Baseline|Total|Total of all reporting groups
92371|NCT02013791|B9|Baseline|Stage 1 Cohort 1|Vehicle administered to study eye and Sham administered to non-study eye on Day 1.
92372|NCT02013791|B8|Baseline|Stage 1 Cohort 6A|Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1.
92373|NCT02013791|B7|Baseline|Stage 1 Cohort 6D|Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
92374|NCT02013791|B6|Baseline|Stage 1 Cohort 6B|Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1.
92375|NCT02013791|B5|Baseline|Stage 1 Cohort 2|Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1.
92376|NCT02013791|B4|Baseline|Stage 1 Cohort 3|Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1.
92377|NCT02013791|B3|Baseline|Stage 1 Cohort 6C|Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
92378|NCT02013791|B2|Baseline|Stage 1 Cohort 4|Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.
92379|NCT02013791|B1|Baseline|Stage 1 Cohort 5A|Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1.
92380|NCT02013791|P9|Participant Flow|Stage 1 Cohort 1|Vehicle administered to study eye and Sham administered to non-study eye on Day 1.
92381|NCT02013791|P8|Participant Flow|Stage 1 Cohort 6A|Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1.
92382|NCT02013791|P7|Participant Flow|Stage 1 Cohort 6D|Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
92383|NCT02013791|P6|Participant Flow|Stage 1 Cohort 6B|Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1.
92384|NCT02013791|P5|Participant Flow|Stage 1 Cohort 2|Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1.
92385|NCT02013791|P4|Participant Flow|Stage 1 Cohort 3|Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1.
92386|NCT02013791|P3|Participant Flow|Stage 1 Cohort 6C|Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
92387|NCT02013791|P2|Participant Flow|Stage 1 Cohort 4|Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.
92388|NCT02013791|P1|Participant Flow|Stage 1 Cohort 5A|Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1.
92389|NCT02013791|O1|Outcome|Stage 1 Cohort 4|Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.
92390|NCT02013791|O9|Outcome|Stage 1 Cohort 1|Vehicle administered to study eye and Sham administered to non-study eye on Day 1.
92391|NCT02013791|O8|Outcome|Stage 1 Cohort 6A|Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1.
92392|NCT02013791|O7|Outcome|Stage 1 Cohort 6D|Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
92393|NCT02013791|O6|Outcome|Stage 1 Cohort 6B|Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1.
92394|NCT02013791|O5|Outcome|Stage 1 Cohort 2|Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1.
92395|NCT02013791|O4|Outcome|Stage 1 Cohort 3|Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1.
92396|NCT02013791|O3|Outcome|Stage 1 Cohort 6C|Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
92397|NCT02013791|O2|Outcome|Stage 1 Cohort 4|Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.
92398|NCT02013791|O1|Outcome|Stage 1 Cohort 5A|Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1.
92399|NCT02013791|E9|Reported Event|Stage 1 Cohort 1|Vehicle administered to study eye and Sham administered to non-study eye on Day 1.
92400|NCT02013791|E8|Reported Event|Stage 1 Cohort 6A|Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1.
92405|NCT02013791|E3|Reported Event|Stage 1 Cohort 6C|Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
92406|NCT02013791|E2|Reported Event|Stage 1 Cohort 4|Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.
92407|NCT02013791|E1|Reported Event|Stage 1 Cohort 5A|Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1.
92408|NCT02013765|B1|Baseline|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
92409|NCT02013765|P1|Participant Flow|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
92410|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
92411|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
92412|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
92413|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
92414|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
92415|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
92416|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
92417|NCT02013765|E1|Reported Event|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
92418|NCT02013687|B5|Baseline|Total|Total of all reporting groups
92419|NCT02013687|B4|Baseline|100 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
92420|NCT02013687|B3|Baseline|30 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
92421|NCT02013687|B2|Baseline|10 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
92422|NCT02013687|B1|Baseline|2 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
92423|NCT02013687|P4|Participant Flow|100 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
92424|NCT02013687|P3|Participant Flow|30 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
92425|NCT02013687|P2|Participant Flow|10 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
92426|NCT02013687|P1|Participant Flow|2 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
92427|NCT02013687|O4|Outcome|100 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
92428|NCT02013687|O3|Outcome|30 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
92429|NCT02013687|O2|Outcome|10 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
92430|NCT02013687|O1|Outcome|2 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
92431|NCT02013687|O4|Outcome|100 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
92432|NCT02013687|O3|Outcome|30 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
92433|NCT02013687|O2|Outcome|10 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
92434|NCT02013687|O1|Outcome|2 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
92435|NCT02013687|O4|Outcome|100 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
92436|NCT02013687|O3|Outcome|30 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
92437|NCT02013687|O2|Outcome|10 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
92438|NCT02013687|O1|Outcome|2 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
92439|NCT02013687|O4|Outcome|100 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
92440|NCT02013687|O3|Outcome|30 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
92441|NCT02013687|O2|Outcome|10 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
92442|NCT02013687|O1|Outcome|2 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
92443|NCT02013687|O4|Outcome|100 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
92444|NCT02013687|O3|Outcome|30 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
92445|NCT02013687|O2|Outcome|10 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
92446|NCT02013687|O1|Outcome|2 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
92447|NCT02013687|O4|Outcome|100 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
92448|NCT02013687|O3|Outcome|30 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
92449|NCT02013687|O2|Outcome|10 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
92450|NCT02013687|O1|Outcome|2 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
92451|NCT02013687|E4|Reported Event|100 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
92452|NCT02013687|E3|Reported Event|30 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
92453|NCT02013687|E2|Reported Event|10 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
92454|NCT02013687|E1|Reported Event|2 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
92455|NCT02013622|B1|Baseline|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
92456|NCT02013622|P1|Participant Flow|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 milligram per day (mg/day) to 4 mg/day, once daily (QD) for 16 Weeks.
92460|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
92461|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
92462|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
92463|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
92464|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
92465|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
92466|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
92467|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
92468|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
92469|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
92470|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
92471|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
92472|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
92473|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
92474|NCT02013622|E1|Reported Event|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
92475|NCT02013609|B1|Baseline|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
92476|NCT02013609|P1|Participant Flow|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 milligram per day (mg/day) for the first week with titration up to 3 mg/day once daily (QD) in addition to their constant-dose antidepressant therapy (ADT) for 12 weeks.
92477|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
92478|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
92479|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
92480|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
92481|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
92482|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
92483|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
92484|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
92485|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
92486|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
92487|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
92488|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
92489|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
92490|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
92491|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
92492|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
92493|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
92494|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
92495|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
92496|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
92712|NCT02013050|O1|Outcome|Placebo|
92497|NCT02013609|E1|Reported Event|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
92498|NCT02013544|B3|Baseline|Total|Total of all reporting groups
92499|NCT02013544|B2|Baseline|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
92500|NCT02013544|B1|Baseline|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
92501|NCT02013544|P2|Participant Flow|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
92502|NCT02013544|P1|Participant Flow|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks
92503|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
92504|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
92505|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
92506|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
92507|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
92508|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
92509|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
92510|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
92511|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
92512|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
92513|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
92514|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
92515|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
92516|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
92517|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
92518|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
92519|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
92520|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
92521|NCT02013544|E2|Reported Event|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks
92522|NCT02013544|E1|Reported Event|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
92523|NCT02013531|B1|Baseline|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
92524|NCT02013531|P1|Participant Flow|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 milligram per day (mg/day) with titration up to 3 mg/day once daily (QD) in addition to their constant-dose ADT (anti-depressant therapy) for 6 weeks.
92525|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
92526|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
92527|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
92528|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
92529|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
92530|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
92531|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
92532|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
92533|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
92534|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
92535|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
92536|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
92537|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
92713|NCT02013050|E4|Reported Event|6.0 mg/kg|
92538|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
92539|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
92540|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
92541|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
92542|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
92543|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
92544|NCT02013531|E1|Reported Event|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day to 3 mg/day, QD for 6 weeks.
92545|NCT02013388|B9|Baseline|Total|Total of all reporting groups
92546|NCT02013388|B8|Baseline|Placebo- Single Dose|single oral dose Placebo: Given PO daily for 1day
92547|NCT02013388|B7|Baseline|250 mg (Fed)|"single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)~N91115: Given PO only on Day 1"
92548|NCT02013388|B6|Baseline|50 mg (Single Dose)|"single oral dose of 50 mg N91115~N91115: Given PO only on Day 1"
92549|NCT02013388|B5|Baseline|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
92550|NCT02013388|B4|Baseline|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
92551|NCT02013388|B3|Baseline|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
92552|NCT02013388|B2|Baseline|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
92553|NCT02013388|B1|Baseline|Placebo|"single oral daily dose of placebo for 14 days~Placebo: Given PO daily for 14 days"
92554|NCT02013388|P8|Participant Flow|Placebo-single Dose|Placebo: Given PO daily for 1 day
92555|NCT02013388|P7|Participant Flow|250 mg (Fed)|"single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)~N91115: Given PO only on Day 1"
92556|NCT02013388|P6|Participant Flow|50 mg (Single Dose)|"single oral dose of 50 mg N91115~N91115: Given PO only on Day 1"
92557|NCT02013388|P5|Participant Flow|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
92558|NCT02013388|P4|Participant Flow|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
92559|NCT02013388|P3|Participant Flow|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
92560|NCT02013388|P2|Participant Flow|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
92561|NCT02013388|P1|Participant Flow|Placebo|"single oral daily dose of placebo for 14 days~Placebo: Given PO daily for 14 days"
92562|NCT02013388|O4|Outcome|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
92563|NCT02013388|O3|Outcome|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
92564|NCT02013388|O2|Outcome|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
92565|NCT02013388|O1|Outcome|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
92566|NCT02013388|O4|Outcome|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
92567|NCT02013388|O3|Outcome|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
92568|NCT02013388|O2|Outcome|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
92569|NCT02013388|O1|Outcome|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
92570|NCT02013388|O4|Outcome|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
92571|NCT02013388|O3|Outcome|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
92572|NCT02013388|O2|Outcome|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
92573|NCT02013388|O1|Outcome|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
92574|NCT02013388|O4|Outcome|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
92575|NCT02013388|O3|Outcome|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
92576|NCT02013388|O2|Outcome|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
92577|NCT02013388|O1|Outcome|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
92578|NCT02013388|O8|Outcome|Placebo- Single Dose|single oral dose Placebo: Given PO daily for 1day
92579|NCT02013388|O7|Outcome|250 mg (Fed)|"single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)~N91115: Given PO only on Day 1"
92580|NCT02013388|O6|Outcome|50 mg (Single Dose)|"single oral dose of 50 mg N91115~N91115: Given PO only on Day 1"
92581|NCT02013388|O5|Outcome|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
92582|NCT02013388|O4|Outcome|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
92583|NCT02013388|O3|Outcome|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
92584|NCT02013388|O2|Outcome|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
92585|NCT02013388|O1|Outcome|Placebo|"single oral daily dose of placebo for 14 days~Placebo: Given PO daily for 14 days"
92586|NCT02013388|E8|Reported Event|Placebo- Single Dose|single oral dose Placebo: Given PO daily for 1day
92587|NCT02013388|E7|Reported Event|250 mg (Fed)|"single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)~N91115: Given PO only on Day 1"
92588|NCT02013388|E6|Reported Event|50 mg (Single Dose)|"single oral dose of 50 mg N91115~N91115: Given PO only on Day 1"
92589|NCT02013388|E5|Reported Event|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
92590|NCT02013388|E4|Reported Event|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
92591|NCT02013388|E3|Reported Event|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
92592|NCT02013388|E2|Reported Event|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
92593|NCT02013388|E1|Reported Event|Placebo|"single oral daily dose of placebo for 14 days~Placebo: Given PO daily for 14 days"
92594|NCT02013245|B5|Baseline|Total|Total of all reporting groups
92595|NCT02013245|B4|Baseline|BCG Control Group|BCG standard dose group (5 x 10^5 CFU BCG)
92596|NCT02013245|B3|Baseline|Group 3|MTBVAC high dose group (5 x 10^5 CFU MTBVAC)
92597|NCT02013245|B2|Baseline|Group 2|MTBVAC intermediate dose group (5 x 10^4 CFU MTBVAC)
92598|NCT02013245|B1|Baseline|Group 1|MTBVAC low dose group (5 x 10^3 CFU MTBVAC)
92599|NCT02013245|P4|Participant Flow|BCG Control Group|Intervention: Commercially available BCG live vaccine (dose 5 x 10^5 CFU)
92600|NCT02013245|P3|Participant Flow|MTBVAC Group 3|Intervention: MTBVAC live vaccine (high dose 5 x 10^5 CFU)
92601|NCT02013245|P2|Participant Flow|MTBVAC Group 2|Intervention: MTBVAC live vaccine (middle dose 5 x 10^4 CFU)
92602|NCT02013245|P1|Participant Flow|MTBVAC Group 1|Intervention: MTBVAC live vaccine (low dose 5 x 10^3 CFU)
92603|NCT02013245|O4|Outcome|BCG Control Group|Intervention: Commercially available BCg live vaccine (standard dose 5 x 10^5 CFU)
92604|NCT02013245|O3|Outcome|MTBVAC Group 3|Intervention: MTBVAC live vaccine (high dose 5 x 10^5 CFU)
92605|NCT02013245|O2|Outcome|MTBVAC Group 2|Intervention: MTBVAC live vaccine (middle dose 5 x 10^4 CFU)
92606|NCT02013245|O1|Outcome|MTBVAC Group 1|Intervention: MTBVAC live vaccine (low dose 5 x 10^3 CFU)
92607|NCT02013245|O4|Outcome|BCG Control Group|Intervention: Commercially available BCg live vaccine (standard dose 5 x 10^5 CFU)
92608|NCT02013245|O3|Outcome|MTBVAC Group 3|Intervention: MTBVAC live vaccine (high dose 5 x 10^5 CFU)
92609|NCT02013245|O2|Outcome|MTBVAC Group 2|Intervention: MTBVAC live vaccine (middle dose 5 x 10^4 CFU)
92610|NCT02013245|O1|Outcome|MTBVAC Group 1|Intervention: MTBVAC live vaccine (low dose 5 x 10^3 CFU)
92611|NCT02013245|E4|Reported Event|BCG Control Group|Intervention: Commercially available BCG live vaccine (standard dose 5 x 10^5 CFU)
92612|NCT02013245|E3|Reported Event|MTBVAC Group 3|Intervention: MTBVAC live vaccine (high dose 5 x 10^5 CFU)
92613|NCT02013245|E2|Reported Event|MTBVAC Group 2|Intervention: MTBVAC live vaccine (middle dose 5 x 10^4 CFU)
92614|NCT02013245|E1|Reported Event|MTBVAC Group 1|Intervention: MTBVAC live vaccine (low dose 5 x 10^3 CFU)
92615|NCT02013206|B3|Baseline|Total|Total of all reporting groups
92616|NCT02013206|B2|Baseline|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
92617|NCT02013206|B1|Baseline|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
92618|NCT02013206|P2|Participant Flow|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
92619|NCT02013206|P1|Participant Flow|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
92620|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
92621|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
92622|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
92623|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
92624|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
92625|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
92626|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
92627|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
92628|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
92629|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
92630|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
92631|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
92632|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
92633|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
92634|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
92635|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
92636|NCT02013206|E2|Reported Event|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
92637|NCT02013206|E1|Reported Event|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
92638|NCT02013167|B3|Baseline|Total|Total of all reporting groups
92639|NCT02013167|B2|Baseline|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.~The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
92640|NCT02013167|B1|Baseline|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
92641|NCT02013167|P2|Participant Flow|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.~The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
92642|NCT02013167|P1|Participant Flow|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
92714|NCT02013050|E3|Reported Event|3.0 mg/kg|
92715|NCT02013050|E2|Reported Event|1.5 mg/kg|
92716|NCT02013050|E1|Reported Event|Placebo|
92717|NCT02012686|B3|Baseline|Total|Total of all reporting groups
92718|NCT02012686|B2|Baseline|TENS Group|numerical rating scale of TENS applied group
92643|NCT02013167|O2|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.~The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
92644|NCT02013167|O1|Outcome|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
92645|NCT02013167|O1|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.~The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
92646|NCT02013167|O2|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.~The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
92647|NCT02013167|O1|Outcome|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
92648|NCT02013167|O2|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.~The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
92649|NCT02013167|O1|Outcome|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
92650|NCT02013167|O2|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.~The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
92651|NCT02013167|O1|Outcome|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
92719|NCT02012686|B1|Baseline|Control Group|numerical rating scale of TENS non-applied group
92720|NCT02012686|P2|Participant Flow|TENS Group|"numerical rating scale of TENS applied group~TENS: transcutaneous electric nerve stimulation"
92721|NCT02012686|P1|Participant Flow|Control Group|numerical rating scale of TENS non-applied group
92722|NCT02012686|O2|Outcome|TENS Group|"numerical rating scale of TENS applied group~TENS: transcutaneous electric nerve stimulation"
92723|NCT02012686|O1|Outcome|Control Group|numerical rating scale of TENS non-applied group
92724|NCT02012686|O2|Outcome|TENS Group|"numerical rating scale of TENS applied group~TENS: transcutaneous electric nerve stimulation"
92652|NCT02013167|O2|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.~The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
92653|NCT02013167|O1|Outcome|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
92654|NCT02013167|O2|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.~The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
92655|NCT02013167|O1|Outcome|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
92656|NCT02013167|O2|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.~The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
92657|NCT02013167|O1|Outcome|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
92658|NCT02013167|O2|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.~The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
92659|NCT02013167|O1|Outcome|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
92660|NCT02013167|O2|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.~The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
92661|NCT02013167|O1|Outcome|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
92725|NCT02012686|O1|Outcome|Control Group|numerical rating scale of TENS non-applied group
92726|NCT02012686|O2|Outcome|TENS Group|"numerical rating scale of TENS applied group~TENS: transcutaneous electric nerve stimulation"
92662|NCT02013167|O2|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.~The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
92663|NCT02013167|O1|Outcome|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
92664|NCT02013167|O2|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.~The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
92665|NCT02013167|O1|Outcome|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
92666|NCT02013167|E2|Reported Event|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.~The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
92667|NCT02013167|E1|Reported Event|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
92668|NCT02013050|B5|Baseline|Total|Total of all reporting groups
92669|NCT02013050|B4|Baseline|6.0 mg/kg|
92670|NCT02013050|B3|Baseline|3.0 mg/kg|
92671|NCT02013050|B2|Baseline|1.5 mg/kg|
92672|NCT02013050|B1|Baseline|Placebo|
92673|NCT02013050|P4|Participant Flow|6.0 mg/kg|Administered as a 4-minute intravenous (IV) infusion, every 3 days (±1 day) while receiving radiation therapy to a maximum of 14 doses
92674|NCT02013050|P3|Participant Flow|3.0 mg/kg|Administered as a 4-minute intravenous (IV) infusion, every 3 days (±1 day) while receiving radiation therapy to a maximum of 14 doses
92675|NCT02013050|P2|Participant Flow|1.5 mg/kg|Administered as a 4-minute intravenous (IV) infusion, every 3 days (±1 day) while receiving radiation therapy to a maximum of 14 doses
92676|NCT02013050|P1|Participant Flow|Placebo|Administered as a 4-minute intravenous (IV) infusion, every 3 days (±1 day) while receiving radiation therapy to a maximum of 14 doses
92677|NCT02013050|O4|Outcome|6.0 mg/kg|
92678|NCT02013050|O3|Outcome|3.0 mg/kg|
92679|NCT02013050|O2|Outcome|1.5 mg/kg|
92680|NCT02013050|O1|Outcome|Placebo|
92681|NCT02013050|O4|Outcome|6.0 mg/kg|
92682|NCT02013050|O3|Outcome|3.0 mg/kg|
92683|NCT02013050|O2|Outcome|1.5 mg/kg|
92684|NCT02013050|O1|Outcome|Placebo|
92685|NCT02013050|O4|Outcome|6.0 mg/kg|
92686|NCT02013050|O3|Outcome|3.0 mg/kg|
92687|NCT02013050|O2|Outcome|1.5 mg/kg|
92688|NCT02013050|O1|Outcome|Placebo|
92689|NCT02013050|O4|Outcome|6.0 mg/kg|
92690|NCT02013050|O3|Outcome|3.0 mg/kg|
92691|NCT02013050|O2|Outcome|1.5 mg/kg|
92692|NCT02013050|O1|Outcome|Placebo|
92693|NCT02013050|O4|Outcome|6.0 mg/kg|
92694|NCT02013050|O3|Outcome|3.0 mg/kg|
92695|NCT02013050|O2|Outcome|1.5 mg/kg|
92696|NCT02013050|O1|Outcome|Placebo|
92697|NCT02013050|O4|Outcome|6.0 mg/kg|
92698|NCT02013050|O3|Outcome|3.0 mg/kg|
92699|NCT02013050|O2|Outcome|1.5 mg/kg|
92700|NCT02013050|O1|Outcome|Placebo|
92701|NCT02013050|O4|Outcome|6.0 mg/kg|
92702|NCT02013050|O3|Outcome|3.0 mg/kg|
92703|NCT02013050|O2|Outcome|1.5 mg/kg|
92704|NCT02013050|O1|Outcome|Placebo|
92705|NCT02013050|O4|Outcome|6.0 mg/kg|
92706|NCT02013050|O3|Outcome|3.0 mg/kg|
92707|NCT02013050|O2|Outcome|1.5 mg/kg|
92708|NCT02013050|O1|Outcome|Placebo|
92728|NCT02012686|O2|Outcome|TENS Group|"numerical rating scale of TENS applied group~TENS: transcutaneous electric nerve stimulation"
92729|NCT02012686|O1|Outcome|Control Group|numerical rating scale of TENS non-applied group
92730|NCT02012686|E2|Reported Event|TENS Group|"numerical rating scale of TENS applied group~TENS: transcutaneous electric nerve stimulation"
92731|NCT02012686|E1|Reported Event|Control Group|numerical rating scale of TENS non-applied group
92732|NCT02012582|B5|Baseline|Total|Total of all reporting groups
92733|NCT02012582|B4|Baseline|Placebo|"0.9 % Sodium chloride infusion~Saline"
92734|NCT02012582|B3|Baseline|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
92735|NCT02012582|B2|Baseline|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
92736|NCT02012582|B1|Baseline|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
92737|NCT02012582|P4|Participant Flow|Placebo|"0.9 % Sodium chloride infusion~Placebo"
92738|NCT02012582|P3|Participant Flow|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
92739|NCT02012582|P2|Participant Flow|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
92740|NCT02012582|P1|Participant Flow|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
92741|NCT02012582|O4|Outcome|Placebo|"0.9 % Sodium chloride infusion~Placebo"
92742|NCT02012582|O3|Outcome|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
92743|NCT02012582|O2|Outcome|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
92744|NCT02012582|O1|Outcome|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
92745|NCT02012582|O4|Outcome|Placebo|"0.9 % Sodium chloride infusion~Placebo"
92746|NCT02012582|O3|Outcome|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
92747|NCT02012582|O2|Outcome|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
92748|NCT02012582|O1|Outcome|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
92749|NCT02012582|O4|Outcome|Placebo|"0.9 % Sodium chloride infusion~Placebo"
92750|NCT02012582|O3|Outcome|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
92751|NCT02012582|O2|Outcome|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
92752|NCT02012582|O1|Outcome|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
92753|NCT02012582|O4|Outcome|Placebo|"0.9 % Sodium chloride infusion~Placebo"
92754|NCT02012582|O3|Outcome|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
92755|NCT02012582|O2|Outcome|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
92756|NCT02012582|O1|Outcome|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
92757|NCT02012582|O4|Outcome|Placebo|"0.9 % Sodium chloride infusion~Placebo"
92758|NCT02012582|O3|Outcome|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
92759|NCT02012582|O2|Outcome|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
92760|NCT02012582|O1|Outcome|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
92761|NCT02012582|E4|Reported Event|Placebo|"0.9 % Sodium chloride infusion~Placebo"
92762|NCT02012582|E3|Reported Event|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
92763|NCT02012582|E2|Reported Event|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
92764|NCT02012582|E1|Reported Event|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
92765|NCT02012452|B3|Baseline|Total|Total of all reporting groups
92766|NCT02012452|B2|Baseline|Health Education Treatment|"Participants will be provided education on a variety of health topics and will set health goals around each topic~Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic"
92767|NCT02012452|B1|Baseline|Tobacco Treatment|"participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment~Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment"
92768|NCT02012452|P2|Participant Flow|Health Education Treatment|"Participants will be provided education on a variety of health topics and will set health goals around each topic~Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic"
92769|NCT02012452|P1|Participant Flow|Tobacco Treatment|"participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment~Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment"
92770|NCT02012452|O2|Outcome|Health Education Treatment|"Participants will be provided education on a variety of health topics and will set health goals around each topic~Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic"
92771|NCT02012452|O1|Outcome|Tobacco Treatment|"participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment~Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment"
92772|NCT02012452|O2|Outcome|Health Education Treatment|"Participants will be provided education on a variety of health topics and will set health goals around each topic~Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic"
92940|NCT02011464|E1|Reported Event|Exparel Inflitration|Exparel infiltrated into the posterior compartment of the knee
92773|NCT02012452|O1|Outcome|Tobacco Treatment|"participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment~Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment"
92774|NCT02012452|E2|Reported Event|Health Education Treatment|"Participants will be provided education on a variety of health topics and will set health goals around each topic~Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic"
92775|NCT02012452|E1|Reported Event|Tobacco Treatment|"participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment~Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment"
92776|NCT02012218|B6|Baseline|Total|Total of all reporting groups
92777|NCT02012218|B5|Baseline|Group 4|Participants who had received a prescribed number of tablets of stimulants such as modafinil, methylphenidate, or psychostimulant (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
92778|NCT02012218|B4|Baseline|Group 3|Participants who had received a prescribed number of tablets of bupropion (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
92779|NCT02012218|B3|Baseline|Group 2|Participants who had received a prescribed number of tablets of any Selective Serotonin Reuptake Inhibitors (SSRI), any Serotonin-norepinephrine Reuptake Inhibitors (SNRI), any tricyclic antidepressant, or Oleptro (trazodone hydrochloride) IR or XR (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
92780|NCT02012218|B2|Baseline|Group 1B|Participants who had received a prescribed number of tablets of quetiapine IR (immediate release) or XR (extended release) (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
92781|NCT02012218|B1|Baseline|Group 1A|Participants who had received a prescribed number of tablets of aripiprazole (baseline/primary antidepressant therapy [ADT]) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
92782|NCT02012218|P5|Participant Flow|Group 4|Participants who had received a prescribed number of tablets of stimulants such as modafinil, methylphenidate, or psychostimulant (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
92783|NCT02012218|P4|Participant Flow|Group 3|Participants who had received a prescribed number of tablets of bupropion (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
92784|NCT02012218|P3|Participant Flow|Group 2|Participants who had received a prescribed number of tablets of any Selective Serotonin Reuptake Inhibitors (SSRI), any Serotonin-norepinephrine Reuptake Inhibitors (SNRI), any tricyclic antidepressant, or Oleptro (trazodone hydrochloride) IR or XR (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
92785|NCT02012218|P2|Participant Flow|Group 1B|Participants who had received a prescribed number of tablets of quetiapine IR (immediate release) or XR (extended release) (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
92786|NCT02012218|P1|Participant Flow|Group 1A|Participants who had received a prescribed number of tablets of aripiprazole (baseline/primary antidepressant therapy [ADT]) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
92787|NCT02012218|O5|Outcome|Group 4|Participants who had received a prescribed number of tablets of stimulants such as modafinil, methylphenidate, or psychostimulant (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
92788|NCT02012218|O4|Outcome|Group 3|Participants who had received a prescribed number of tablets of bupropion (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
92789|NCT02012218|O3|Outcome|Group 2|Participants who had received a prescribed number of tablets of any Selective Serotonin Reuptake Inhibitors (SSRI), any Serotonin-norepinephrine Reuptake Inhibitors (SNRI), any tricyclic antidepressant, or Oleptro (trazodone hydrochloride) IR or XR (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
92790|NCT02012218|O2|Outcome|Group 1B|Participants who had received a prescribed number of tablets of quetiapine IR (immediate release) or XR (extended release) (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
92791|NCT02012218|O1|Outcome|Group 1A|Participants who had received a prescribed number of tablets of aripiprazole (baseline/primary antidepressant therapy [ADT]) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
92792|NCT02012218|E5|Reported Event|Group 4|Participants who had received a prescribed number of tablets of stimulants such as modafinil, methylphenidate, or psychostimulant (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
92793|NCT02012218|E4|Reported Event|Group 3|Participants who had received a prescribed number of tablets of bupropion (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
92794|NCT02012218|E3|Reported Event|Group 2|Participants who had received a prescribed number of tablets of any Selective Serotonin Reuptake Inhibitors (SSRI), any Serotonin-norepinephrine Reuptake Inhibitors (SNRI), any tricyclic antidepressant, or Oleptro (trazodone hydrochloride) IR or XR (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
92795|NCT02012218|E2|Reported Event|Group 1B|Participants who had received a prescribed number of tablets of quetiapine IR (immediate release) or XR (extended release) (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
92796|NCT02012218|E1|Reported Event|Group 1A|Participants who had received a prescribed number of tablets of aripiprazole (baseline/primary antidepressant therapy [ADT]) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
92797|NCT02011893|B1|Baseline|All Subjects|All subjects who were enrolled in the SUNBURST clinical study
92798|NCT02011893|P3|Participant Flow|Arm 2|Burst stimulation first, then Tonic
92799|NCT02011893|P2|Participant Flow|Arm 1|Tonic stimulation first, then Burst
92800|NCT02011893|P1|Participant Flow|Enrolled|All subjects enrolled through device activation/randomization
92801|NCT02011893|O2|Outcome|Tonic Stimulation|"Tonic Stimulation using the Prodigy system~Tonic Stimulation: Prodigy Neurostimulation System with associated components"
92802|NCT02011893|O1|Outcome|Burst Stimulation|"Burst Stimulation using the Prodigy system~Burst Stimulation: Prodigy Neurostimulation System with associated components"
92803|NCT02011893|O2|Outcome|Tonic Stimulation|"Tonic Stimulation using the Prodigy system~Tonic Stimulation: Prodigy Neurostimulation System with associated components"
92804|NCT02011893|O1|Outcome|Burst Stimulation|"Burst Stimulation using the Prodigy system~Burst Stimulation: Prodigy Neurostimulation System with associated components"
92805|NCT02011893|O2|Outcome|Tonic Stimulation|"Tonic Stimulation using the Prodigy system~Tonic Stimulation: Prodigy Neurostimulation System with associated components"
92806|NCT02011893|O1|Outcome|Burst Stimulation|"Burst Stimulation using the Prodigy system~Burst Stimulation: Prodigy Neurostimulation System with associated components"
92807|NCT02011893|O2|Outcome|Tonic Stimulation|"Tonic Stimulation using the Prodigy system~Tonic Stimulation: Prodigy Neurostimulation System with associated components"
92808|NCT02011893|O1|Outcome|Burst Stimulation|"Burst Stimulation using the Prodigy system~Burst Stimulation: Prodigy Neurostimulation System with associated components"
92809|NCT02011893|E1|Reported Event|All Subjects|All subjects who were enrolled in the SUNBURST clinical study
92810|NCT02011542|B1|Baseline|VSL #3 or Placebo|Study participants enrolled into the VSL #3 arm or the Placebo arm
92811|NCT02011542|P1|Participant Flow|VSL #3 or Placebo|Study participants enrolled into the VSL #3 arm or the Placebo arm
92812|NCT02011542|O1|Outcome|VSL #3 or Placebo|Study participants enrolled into the VSL #3 arm or the Placebo arm
92813|NCT02011542|O1|Outcome|VSL #3 or Placebo|Study participants enrolled into the VSL #3 arm or the Placebo arm
92814|NCT02011542|E1|Reported Event|VSL #3 or Placebo|Study participants enrolled into the VSL #3 arm or the Placebo arm
92815|NCT02011516|B3|Baseline|Total|Total of all reporting groups
92816|NCT02011516|B2|Baseline|Baclofen, Psychosocial Intervention|"20 mg. q.i.d. twice weekly appointments with a certified clinician~Baclofen~Psychosocial"
92817|NCT02011516|B1|Baseline|Sugar Pill, Psychosocial Intervention|"twice weekly appointments with a certified clinician~Psychosocial~Placebo"
92818|NCT02011516|P2|Participant Flow|Baclofen, Psychosocial Intervention|"20 mg. q.i.d. twice weekly appointments with a certified clinician~Baclofen~Psychosocial"
92819|NCT02011516|P1|Participant Flow|Sugar Pill, Psychosocial Intervention|"twice weekly appointments with a certified clinician~Psychosocial~Placebo"
92820|NCT02011516|O2|Outcome|Baclofen, Psychosocial Intervention|"20 mg. q.i.d. twice weekly appointments with a certified clinician~Baclofen~Psychosocial"
92821|NCT02011516|O1|Outcome|Sugar Pill, Psychosocial Intervention|"twice weekly appointments with a certified clinician~Psychosocial~Placebo"
92822|NCT02011516|E2|Reported Event|Baclofen, Psychosocial Intervention|"20 mg. q.i.d. twice weekly appointments with a certified clinician~Baclofen~Psychosocial"
92823|NCT02011516|E1|Reported Event|Sugar Pill, Psychosocial Intervention|"twice weekly appointments with a certified clinician~Psychosocial~Placebo"
92824|NCT02011490|B4|Baseline|Total|Total of all reporting groups
92825|NCT02011490|B3|Baseline|Healthy Control Participants: Part 1 + Part 2|This group includes healthy control participants who were included in Part 1, Part 2, or in both Part 1 and Part 2. Participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port.
92826|NCT02011490|B2|Baseline|Moderate Renal Insufficiency Participants: Part 1 + Part 2|This group includes participants with moderate renal insufficiency who were included in Part 1, Part 2, or in both Part 1 and Part 2. Participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port.
92827|NCT02011490|B1|Baseline|Severe Renal Insufficiency Participants: Part 1 + Part 2|This group includes participants with severe renal insufficiency who were included in Part 1, Part 2, or in both Part 1 and Part 2. Participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port.
92828|NCT02011490|P6|Participant Flow|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92829|NCT02011490|P5|Participant Flow|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
93406|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
92830|NCT02011490|P4|Participant Flow|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92831|NCT02011490|P3|Participant Flow|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92832|NCT02011490|P2|Participant Flow|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92833|NCT02011490|P1|Participant Flow|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an intravenous (IV) bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92834|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92835|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92836|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92837|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92838|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92839|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92840|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92841|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92842|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92843|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92844|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92845|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92846|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92847|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92867|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
93407|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
92848|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92849|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92850|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92851|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92852|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92853|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92854|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92855|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92856|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92857|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92858|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92859|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92860|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92861|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92862|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92863|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92864|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92865|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92866|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92868|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92869|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92870|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92871|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92872|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92873|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92874|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92875|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92876|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92877|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92878|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92879|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92880|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92881|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92882|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92883|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92884|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92885|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92886|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92938|NCT02011464|O1|Outcome|Exparel Group/Average Pain Scores at 4 Hours|Pain scores using the Number Rating Scale (NRS) from 0 - 10
92887|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92888|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92889|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92890|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92891|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92892|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92893|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92894|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92895|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92896|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92897|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92898|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92899|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92900|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92901|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92902|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92903|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92904|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92905|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92939|NCT02011464|E2|Reported Event|Control|Saline infiltrated into posterior compartment
92906|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92907|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92908|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92909|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92910|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92911|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92912|NCT02011490|E6|Reported Event|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92913|NCT02011490|E5|Reported Event|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92914|NCT02011490|E4|Reported Event|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
92915|NCT02011490|E3|Reported Event|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92916|NCT02011490|E2|Reported Event|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92917|NCT02011490|E1|Reported Event|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
92918|NCT02011464|B3|Baseline|Total|Total of all reporting groups
92919|NCT02011464|B2|Baseline|Control|Saline infiltrated into posterior compartment
92920|NCT02011464|B1|Baseline|Exparel Inflitration|Exparel infiltrated into the posterior compartment of the knee
92921|NCT02011464|P2|Participant Flow|Control|Saline infiltrated into posterior compartment of the knee
92922|NCT02011464|P1|Participant Flow|Exparel Inflitration|Exparel infiltrated into the posterior compartment of the knee
92923|NCT02011464|O2|Outcome|Control|Saline infiltrated into posterior compartment
92924|NCT02011464|O1|Outcome|Exparel Inflitration|Exparel infiltrated into the posterior compartment of the knee
92925|NCT02011464|O2|Outcome|Control|Saline infiltrated into posterior compartment
92926|NCT02011464|O1|Outcome|Exparel Inflitration|Exparel infiltrated into the posterior compartment of the knee
92927|NCT02011464|O12|Outcome|Control Group/Average Pain Scores at 72 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
92928|NCT02011464|O11|Outcome|Exparel Group/Average Pain Scores at 72 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
92929|NCT02011464|O10|Outcome|Control Group/Average Pain Scores at 48 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
92930|NCT02011464|O9|Outcome|Exparel Group/Average Pain Scores at 48 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
92931|NCT02011464|O8|Outcome|Control Group/Average Pain Scores at 24 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
92932|NCT02011464|O7|Outcome|Exparel Group/Average Pain Scores at 24 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
92933|NCT02011464|O6|Outcome|Control Group/Average Pain Scores at 12 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
92934|NCT02011464|O5|Outcome|Exparel Group/Average Pain Scores at 12 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
92935|NCT02011464|O4|Outcome|Control Group/Average Pain Scores at 8 Hours|Pain scores using the Number Rating Scale (NRS) from 0 - 10
92936|NCT02011464|O3|Outcome|Exparel Group/Average Pain Scores at 8 Hours|Pain scores using the Number Rating Scale (NRS) from 0 - 10
92937|NCT02011464|O2|Outcome|Control Group/Average Pain Scores at 4 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
92941|NCT02011113|B1|Baseline|Pomalidomide Plus Dexamethasone|Pomalidomide: 4 mg oral pomalidomide once daily Days 1-21 of each 28-day cycle Dexamethasone: 40 mg or 20 mg oral dexamethasone once daily on Days 1, 8, 15, 22 of each 28-day cycle
92942|NCT02011113|P1|Participant Flow|Pomalidomide Plus Dexamethasone|Pomalidomide 4 mg by mouth (PO) daily (QD) on Days 1-21 of each 28-day cycle. Dexamethasone 40 mg PO once daily on Days 1, 8, 15, 22 of each 28-day cycle for those who are ≤ 75 years of age Dexamethasone 20 mg PO once daily on Days 1, 8, 15, 22 of each 28-day cycle for those who are > 75 years of age
92943|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression or pomalidomide discontinuation for any reason.
92944|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
92945|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
92946|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
92947|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
92948|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
92949|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
92950|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
92951|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
92952|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
92953|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
92954|NCT02011113|E1|Reported Event|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression or pomalidomide discontinuation for any reason.
92955|NCT02010996|B3|Baseline|Total|Total of all reporting groups
92956|NCT02010996|B2|Baseline|Axillary Dissection|"Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).~Axillary dissection: Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids)."
92957|NCT02010996|B1|Baseline|Vacuum Assisted Closure|"Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.~vacuum assisted closure: Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site."
92958|NCT02010996|P2|Participant Flow|Axillary Dissection|"Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).~Axillary dissection: Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids)."
92959|NCT02010996|P1|Participant Flow|Vacuum Assisted Closure|"Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.~vacuum assisted closure: Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site."
92960|NCT02010996|O4|Outcome|Axillary Dissection(Shank)|
92961|NCT02010996|O3|Outcome|Vacuum Assisted Closure(Shank)|
92962|NCT02010996|O2|Outcome|Axillary Dissection(Thigh)|"Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).~Axillary dissection: Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids)."
92963|NCT02010996|O1|Outcome|Vacuum Assisted Closure(Thigh)|"Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.~vacuum assisted closure: Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site."
92964|NCT02010996|E4|Reported Event|Axillary Dissection(Shank)|
92965|NCT02010996|E3|Reported Event|Vacuum Assisted Closure(Shank)|
92966|NCT02010996|E2|Reported Event|Axillary Dissection(Thigh)|"Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).~Axillary dissection: Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids)."
92967|NCT02010996|E1|Reported Event|Vacuum Assisted Closure(Thigh)|"Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.~vacuum assisted closure: Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site."
92968|NCT02010684|B3|Baseline|Total|Total of all reporting groups
92969|NCT02010684|B2|Baseline|Empowerment and CBT Classes|"Participants will attend weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants will learn cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants will learn a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
92970|NCT02010684|B1|Baseline|Wait-listed Control Group|Participants in the Wait-listed Control Group will receive augmented access and communication with a primary care provider. The augmentation would consist of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team will also attach a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will also be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
92971|NCT02010684|P2|Participant Flow|Empowerment and CBT Classes|"Participants will attend weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants will learn cognitive behavioral therapy (CBT) techniques to manage their mood. Then participants will learn a diabetes education format grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. Group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis.~Empowerment and CBT Classes: Participants will receive a manual with 3 CBT modules and 1 Diabetes Empowerment module. CBT Module 1 covers Understanding Depression and Diabetes, Module 2 How Thoughts Affect Your Mood and Diabetes Care, Module 3 How Activities Affect Your Mood and Diabetes Care. The Diabetes Empowerment Modu"
92972|NCT02010684|P1|Participant Flow|Wait-listed Control Group|Participants in the Wait-listed Control Group will receive augmented access and communication with a primary care provider. The augmentation would consist of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team will also attach a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will also be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
92973|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
92974|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
93002|NCT02010567|P5|Participant Flow|Cohort B, Phase Ib, Dose Level 2, Weekly|"CRLX101 15mg/ m^2 , via intravenous catheter (IV), on Monday, every week for the first five weeks of chemoradiation.~Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks"
93003|NCT02010567|P4|Participant Flow|Cohort B, Phase Ib, Dose Level 1, Weekly|"CRLX101 12mg/ m^2 , via intravenous catheter (IV), on Monday, every week for the first five weeks of chemoradiation.~Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks"
92975|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
92976|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
92977|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
92978|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
92979|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
92980|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
92981|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
92982|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
92983|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
92984|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
93004|NCT02010567|P3|Participant Flow|Cohort A, Phase II, Dose Level 2|"CRLX101 15mg/ m^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.~Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks"
93005|NCT02010567|P2|Participant Flow|Cohort A, Phase Ib, Dose Level 2|"CRLX101 15mg/ m^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.~Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks"
92985|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
92986|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
92987|NCT02010684|E2|Reported Event|Empowerment and CBT Classes|"Weekly 2-hour group Empowerment and CBT classes for 12 weeks are led by two trained health educators. Cognitive behavioral therapy (CBT) techniques to manage mood and diabetes education, grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood, is presented. Group members monitor their blood sugar levels, blood pressure, and mood on a daily basis. The intervention arm participants receive a manual with 3 CBT modules (Understanding Depression and Diabetes, How Thoughts Affect Your Mood and Diabetes Care, andHow Activities Affect Your Mood and Diabetes Care. and 1 Diabetes Empowerment module. covers topics including the following: food, exercise, medicine, diabetes and your health, social support, communication skills, and community resources."
92988|NCT02010684|E1|Reported Event|Wait-listed Control Group|Participants in the Wait-listed Control Group will receive augmented access and communication with a primary care provider. The augmentation would consist of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team will also attach a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will also be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
92989|NCT02010632|B1|Baseline|All Study Participants|First intervention: Apolets® 75 mg tablet (Generic Clopidogrel Product first, wash out period for 14 days then Original Clopidogrel Product) Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days. Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 Wash out period: 14 days Second intervention: Plavix® 75mg tablet (Original Clopidogrel Product first, wash out period for 14 days then Generic Clopidogrel Product) Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days. Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7
92990|NCT02010632|P2|Participant Flow|Original Clopidogrel Product|"Plavix® 75mg tablet (Original Clopidogrel Product first, wash out period for 14 days then Generic Clopidogrel Product) Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days~-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
92991|NCT02010632|P1|Participant Flow|Generic Clopidogrel Product|"Apolets® 75 mg tablet (Generic Clopidogrel Product first, wash out period for 14 days then Original Clopidogrel Product) Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days~-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
92992|NCT02010632|O2|Outcome|Original Clopidogrel Product|"Plavix® 75mg tablet~Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days~-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
92993|NCT02010632|O1|Outcome|Generic Clopidogrel Product|"Apolets® 75 mg tablet~Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days~-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
92994|NCT02010632|E2|Reported Event|Original Clopidogrel Product|"Plavix® 75mg tablet (Original Clopidogrel Product first, wash out period for 14 days then Generic Clopidogrel Product) Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days~-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
92995|NCT02010632|E1|Reported Event|Generic Clopidogrel Product|"Apolets® 75 mg tablet (Generic Clopidogrel Product first, wash out period for 14 days then Original Clopidogrel Product) Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days~-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
92996|NCT02010567|B6|Baseline|Total|Total of all reporting groups
92997|NCT02010567|B5|Baseline|Cohort B, Phase Ib, Dose Level 2, Weekly|"CRLX101 15mg/ m^2 , via intravenous catheter (IV), on Monday, every week for the first five weeks of chemoradiation.~Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks"
92998|NCT02010567|B4|Baseline|Cohort B, Phase Ib, Dose Level 1, Weekly|"CRLX101 12mg/ m^2 , via intravenous catheter (IV), on Monday, every week for the first five weeks of chemoradiation.~Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks"
92999|NCT02010567|B3|Baseline|Cohort A, Phase II, Dose Level 2|"CRLX101 15mg/ m^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.~Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks"
93000|NCT02010567|B2|Baseline|Cohort A, Phase Ib, Dose Level 2|"CRLX101 15mg/ m^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.~Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks"
93001|NCT02010567|B1|Baseline|Cohort A, Phase Ib, Dose Level 1|"CRLX101 12mg/ m^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.~Capecitabine 825mg/ m^2 by mouth two times a day (PO BID), Monday through Friday (M-F) XRT 180 centigray (cGy)/day, M-F for 6 weeks"
93408|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
93006|NCT02010567|P1|Participant Flow|Cohort A, Phase Ib, Dose Level 1|"CRLX101 12mg/ m^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.~Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks"
93007|NCT02010567|O1|Outcome|All Participants|All resectable participants who received CRLX101 + capecitabine (Cape) and radiation therapy (XRT) regardless of dose and timing of treatment
93008|NCT02010567|O1|Outcome|All Participants|All resectable participants who received CRLX101 + capecitabine (Cape) and radiation therapy (XRT) regardless of dose and timing of treatment
93009|NCT02010567|O1|Outcome|All Participants|All resectable participants who received CRLX101 + capecitabine (Cape) and radiation therapy (XRT) regardless of dose and timing of treatment
93010|NCT02010567|O1|Outcome|Dose Escalation Phase Ib|Phase Ib patients who received at least one dose of CRLX101 at either 12mg/m2 or 15mg/m2 either every other week (Cohort A) or weekly (Cohort B)
93011|NCT02010567|E5|Reported Event|Cohort B, Phase Ib, Level 2|15mg/m^2 CRLX101 IV weekly + 825mg/m^2 BID Capecitabine + XRT
93012|NCT02010567|E4|Reported Event|Cohort B, Phase Ib, Level 1|12mg/m^2 CRLX101 IV weekly + 825mg/m^2 BID Capecitabine + XRT
93013|NCT02010567|E3|Reported Event|Cohort A, Phase II, Level 2|15mg/m^2 CRLX101 IV weekly + 825mg/m^2 BID Capecitabine + XRT
93014|NCT02010567|E2|Reported Event|Cohort A, Phase Ib, Level 2|15mg/m^2 CRLX101 every other week + 825mg/m^2 BID Capecitabine + XRT
93015|NCT02010567|E1|Reported Event|Cohort A, Phase Ib, Level 1|12mg/m^2 CRLX101 every other week + 825mg/m^2 BID Capecitabine + XRT
93016|NCT02010255|B15|Baseline|Total|Total of all reporting groups
93017|NCT02010255|B14|Baseline|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
93018|NCT02010255|B13|Baseline|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
93019|NCT02010255|B12|Baseline|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93020|NCT02010255|B11|Baseline|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93021|NCT02010255|B10|Baseline|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93022|NCT02010255|B9|Baseline|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93023|NCT02010255|B8|Baseline|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
93024|NCT02010255|B7|Baseline|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
93025|NCT02010255|B6|Baseline|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
93026|NCT02010255|B5|Baseline|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
93027|NCT02010255|B4|Baseline|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93028|NCT02010255|B3|Baseline|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93029|NCT02010255|B2|Baseline|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93030|NCT02010255|B1|Baseline|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93031|NCT02010255|P14|Participant Flow|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
93032|NCT02010255|P13|Participant Flow|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
93033|NCT02010255|P12|Participant Flow|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93034|NCT02010255|P11|Participant Flow|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93035|NCT02010255|P10|Participant Flow|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93036|NCT02010255|P9|Participant Flow|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93037|NCT02010255|P8|Participant Flow|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
93038|NCT02010255|P7|Participant Flow|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
93039|NCT02010255|P6|Participant Flow|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
93040|NCT02010255|P5|Participant Flow|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|"LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.~F0: no fibrosis; F1: portal fibrosis without septa; F2: portal fibrosis with rare septa, F3: numerous septa without cirrhosis; F4: cirrhosis."
93041|NCT02010255|P4|Participant Flow|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93042|NCT02010255|P3|Participant Flow|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93043|NCT02010255|P2|Participant Flow|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93044|NCT02010255|P1|Participant Flow|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|"Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily plus ribavirin (RBV) tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with Child-Pugh-Turcotte (CPT) Class B (CPT score 7-9).~CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for study was 12); higher scores indicate greater severity of disease."
93045|NCT02010255|O10|Outcome|Cohort B: Baseline CPT Class C (24 wk)|Includes participants in Cohort B (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
93046|NCT02010255|O9|Outcome|Cohort B: Baseline CPT Class C (12 wk)|Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
93047|NCT02010255|O8|Outcome|Cohort B: Baseline CPT Class B (24 wk)|Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
93048|NCT02010255|O7|Outcome|Cohort B: Baseline CPT Class B (12 wk)|Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
93049|NCT02010255|O6|Outcome|Cohort B: Baseline CPT Class A (24 wk)|Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
93050|NCT02010255|O5|Outcome|Cohort B: Baseline CPT Class A (12 wk)|Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
93051|NCT02010255|O4|Outcome|Cohort A: Baseline CPT Class C (24 wk)|Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
93052|NCT02010255|O3|Outcome|Cohort A: Baseline CPT Class C (12 wk)|Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
93053|NCT02010255|O2|Outcome|Cohort A: Baseline CPT Class B (24 wk)|Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
93054|NCT02010255|O1|Outcome|Cohort A: Baseline CPT Class B (12 wk)|Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
93055|NCT02010255|O10|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93056|NCT02010255|O9|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93057|NCT02010255|O8|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93058|NCT02010255|O7|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93059|NCT02010255|O6|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
93060|NCT02010255|O5|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
93061|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93062|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93063|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93064|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|"LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).~CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for study was 12); higher scores indicate greater severity of disease."
93065|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
93066|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
93067|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93068|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93069|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93070|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93071|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
93072|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
93073|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
93074|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
93075|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93076|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93077|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93078|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93079|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
93080|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
93409|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
93081|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93082|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93083|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93084|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93085|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
93086|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
93087|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
93088|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
93089|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93090|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93091|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93092|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93093|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
93094|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
93095|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93096|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93097|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93098|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93099|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
93100|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
93101|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
93102|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
93103|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93127|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
93104|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93105|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93106|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93107|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
93108|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
93109|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93110|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93111|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93112|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93113|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
93114|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
93115|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
93116|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
93117|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93118|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93119|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93120|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93121|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
93122|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
93123|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93124|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93125|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93126|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93410|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
94262|NCT02005211|O5|Outcome|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
93128|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
93129|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
93130|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
93131|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93132|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93133|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93134|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93135|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
93136|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
93137|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93138|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93139|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93140|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93141|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
93142|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
93143|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
93144|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
93145|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93146|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93147|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93148|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93149|NCT02010255|O7|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
93150|NCT02010255|O6|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93151|NCT02010255|O5|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93152|NCT02010255|O4|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
93153|NCT02010255|O3|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
93154|NCT02010255|O2|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93155|NCT02010255|O1|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93156|NCT02010255|O7|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
93157|NCT02010255|O6|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93158|NCT02010255|O5|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93159|NCT02010255|O4|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
93160|NCT02010255|O3|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
93161|NCT02010255|O2|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93162|NCT02010255|O1|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93163|NCT02010255|O7|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
93164|NCT02010255|O6|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93165|NCT02010255|O5|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93166|NCT02010255|O4|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
93167|NCT02010255|O3|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
93168|NCT02010255|O2|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93169|NCT02010255|O1|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93170|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
93171|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
93172|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93173|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93174|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93175|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93176|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
93177|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
93178|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
93179|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
93180|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93181|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93182|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93183|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93184|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
93185|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
93186|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93187|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93188|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93189|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93190|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
93191|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
93192|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
93193|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
93194|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93195|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93196|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93197|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93198|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
93199|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
93411|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
93200|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93201|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93202|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93203|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93204|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
93205|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
93206|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
93207|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
93208|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93209|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93210|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93211|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93212|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
93213|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
93214|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93215|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93216|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93217|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93218|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
93219|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
93220|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
93221|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
93222|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93246|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
93223|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93224|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93225|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93226|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
93227|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
93228|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93229|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93230|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93231|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93232|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
93233|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
93234|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
93235|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
93236|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93237|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93238|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93239|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93240|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
93241|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
93242|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93243|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93244|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93245|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93412|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
94263|NCT02005211|O4|Outcome|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
93247|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
93248|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
93249|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
93250|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93251|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93252|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93253|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93254|NCT02010255|O1|Outcome|All LDV/SOF+RBV|All participants in the analysis are presented in a single group, regardless of randomization group assignment.
93255|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
93256|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
93257|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93258|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93259|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93260|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93261|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
93262|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
93263|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
93264|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
93265|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93266|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93267|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93268|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93269|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
93270|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
93317|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
93271|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93272|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93273|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93274|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93275|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
93276|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
93277|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
93278|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
93279|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93280|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93281|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93282|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93283|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
93284|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
93285|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93286|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93287|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93288|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93289|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
93290|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
93291|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
93292|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
93293|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93318|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
93294|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93295|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93296|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93297|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
93298|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
93299|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93300|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93301|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93302|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93303|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
93304|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
93305|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
93306|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
93307|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93308|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93309|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93310|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93311|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
93312|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
93313|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93314|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93315|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93316|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93405|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
94264|NCT02005211|O3|Outcome|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
93319|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
93320|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
93321|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93322|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93323|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93324|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93325|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
93326|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
93327|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93328|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93329|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93330|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93331|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
93332|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
93333|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
93334|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
93335|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93336|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93337|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93338|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93339|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
93340|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
93341|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93342|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93343|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93344|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93345|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
93346|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
93347|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
93348|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
93349|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93350|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93351|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93352|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93353|NCT02010255|E14|Reported Event|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
93354|NCT02010255|E13|Reported Event|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
93355|NCT02010255|E12|Reported Event|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93356|NCT02010255|E11|Reported Event|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93357|NCT02010255|E10|Reported Event|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
93358|NCT02010255|E9|Reported Event|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
93359|NCT02010255|E8|Reported Event|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
93360|NCT02010255|E7|Reported Event|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
93361|NCT02010255|E6|Reported Event|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
93362|NCT02010255|E5|Reported Event|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|"LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.~F0: no fibrosis; F1: portal fibrosis without septa; F2: portal fibrosis with rare septa, F3: numerous septa without cirrhosis; F4: cirrhosis."
93363|NCT02010255|E4|Reported Event|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
93364|NCT02010255|E3|Reported Event|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
93365|NCT02010255|E2|Reported Event|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
94265|NCT02005211|O2|Outcome|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
93366|NCT02010255|E1|Reported Event|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|"LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).~CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for study was 12); higher scores indicate greater severity of disease."
93367|NCT02010216|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
93368|NCT02010216|P1|Participant Flow|Tocilizumab [RoActemra/Actemra]|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
93369|NCT02010216|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
93370|NCT02010216|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
93371|NCT02010216|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
93372|NCT02010216|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
93373|NCT02009982|B3|Baseline|Total|Total of all reporting groups
93374|NCT02009982|B2|Baseline|Standard Medical Thearpy|Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.
93375|NCT02009982|B1|Baseline|Cardioneuroablation|"Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter~Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium~Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure"
93376|NCT02009982|P2|Participant Flow|Standard Medical Thearpy|Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.
93377|NCT02009982|P1|Participant Flow|Cardioneuroablation|"Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter~Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium~Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure"
93378|NCT02009982|O2|Outcome|Standard Medical Thearpy|Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.
93379|NCT02009982|O1|Outcome|Cardioneuroablation|"Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter~Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium~Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure"
93380|NCT02009982|O2|Outcome|Standard Medical Thearpy|Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.
93381|NCT02009982|O1|Outcome|Cardioneuroablation|"Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter~Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium~Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure"
93382|NCT02009982|E2|Reported Event|Standard Medical Thearpy|Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.
93383|NCT02009982|E1|Reported Event|Cardioneuroablation|"Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter~Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium~Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure"
93384|NCT02009878|B4|Baseline|Total|Total of all reporting groups
93385|NCT02009878|B3|Baseline|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
93386|NCT02009878|B2|Baseline|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
93387|NCT02009878|B1|Baseline|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
93388|NCT02009878|P3|Participant Flow|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
93389|NCT02009878|P2|Participant Flow|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
93390|NCT02009878|P1|Participant Flow|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
93391|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
93392|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
93393|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
93394|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
93395|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
93396|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
93397|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
93398|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
93399|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
93400|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
93401|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
93402|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
93403|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
93404|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
94266|NCT02005211|O1|Outcome|Placebo Part 1|Placebo Part 1 - SAD
93413|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
93414|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
93415|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
93416|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
93417|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
93418|NCT02009878|E3|Reported Event|Tolvaptan 15 mg|Subjects will receive a single dose of 3.75, 7.5 or 15 mg of tolvaptan on study Day 1
93419|NCT02009878|E2|Reported Event|Tolvaptan 7.5 mg|Subjects will receive a single dose of 3.75, 7.5 or 15 mg of tolvaptan on study Day 1
93420|NCT02009878|E1|Reported Event|Tolvaptan 3.75 mg|Subjects will receive a single dose of 3.75, 7.5 or 15 mg of tolvaptan on study Day 1
93421|NCT02009865|B3|Baseline|Total|Total of all reporting groups
93422|NCT02009865|B2|Baseline|Olive Oil|2g once daily (QD)
93423|NCT02009865|B1|Baseline|Epanova|2g once daily (QD)
93424|NCT02009865|P2|Participant Flow|Olive Oil|2g once daily (QD)
93425|NCT02009865|P1|Participant Flow|Epanova|2g once daily (QD)
93426|NCT02009865|O2|Outcome|Olive Oil|2g once daily (QD)
93427|NCT02009865|O1|Outcome|Epanova|2g once daily (QD)
93428|NCT02009865|O2|Outcome|Olive Oil|2g once daily (QD)
93429|NCT02009865|O1|Outcome|Epanova|2g once daily (QD)
93430|NCT02009865|O2|Outcome|Olive Oil|2g once daily (QD)
93431|NCT02009865|O1|Outcome|Epanova|2g once daily (QD)
93432|NCT02009865|O2|Outcome|Olive Oil|2g once daily (QD)
93433|NCT02009865|O1|Outcome|Epanova|2g once daily (QD)
93434|NCT02009865|O2|Outcome|Olive Oil|2g once daily (QD)
93435|NCT02009865|O1|Outcome|Epanova|2g once daily (QD)
93436|NCT02009865|E2|Reported Event|Olive Oil|2g once daily (QD)
93437|NCT02009865|E1|Reported Event|Epanova|2g once daily (QD)
93438|NCT02009722|B3|Baseline|Total|Total of all reporting groups
93439|NCT02009722|B2|Baseline|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
93440|NCT02009722|B1|Baseline|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
93441|NCT02009722|P2|Participant Flow|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
93442|NCT02009722|P1|Participant Flow|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
93443|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
93444|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
93445|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
93446|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
93447|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
93993|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
93448|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
93449|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
93450|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
93451|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
93452|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
93453|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
93454|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
93455|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
93456|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
93457|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
93458|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
93459|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
93460|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
93461|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
94267|NCT02005211|O5|Outcome|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
93462|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
93463|NCT02009722|E2|Reported Event|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
93464|NCT02009722|E1|Reported Event|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
93465|NCT02009696|B1|Baseline|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
93466|NCT02009696|P1|Participant Flow|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
93467|NCT02009696|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
93468|NCT02009696|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
93469|NCT02009696|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
93470|NCT02009696|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
93471|NCT02009696|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
93472|NCT02009696|E1|Reported Event|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
93473|NCT02009163|B1|Baseline|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.
93474|NCT02009163|P3|Participant Flow|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26­week double-blind randomized-withdrawal phase, participants were followed for 1 week.
93475|NCT02009163|P2|Participant Flow|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
93476|NCT02009163|P1|Participant Flow|SPD489 (Open-label Period)|SPD489 treatment was taken orally once daily at approximately 7:00 AM. All participants began treatment with SPD489 at the lowest dose level (30mg) during the 4-week open-label dose-optimization period. After 1 week of treatment at 30mg, all participants were titrated to the next dose level (50mg). After 1 week of treatment at 50mg, all participants were titrated to the highest dose level (70mg), as tolerated and as clinically indicated. After 1 week of treatment at the highest dose, the participant could have been down-titrated to 50mg; no further dose adjustments were permitted. The optimal daily dose of 50 or 70mg achieved during dose-optimization was maintained throughout the 8-week dose-maintenance period. The total time of the open-label period was 12 weeks.
93477|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
93478|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
93479|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
93480|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
93481|NCT02009163|O1|Outcome|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label phase and who had a post-baseline safety assessment.
93482|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
93483|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
93484|NCT02009163|O1|Outcome|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.
93485|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
93486|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
93487|NCT02009163|O1|Outcome|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.
93488|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
93489|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
93490|NCT02009163|O1|Outcome|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.
93491|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
93492|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
93493|NCT02009163|O1|Outcome|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.
93494|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
93495|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
93496|NCT02009163|O1|Outcome|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.
93497|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
93498|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
93499|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
93500|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
93501|NCT02009163|O2|Outcome|SPD489 (Randomized­-Withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70 mg was continued throughout the 26-week double-blind randomized-­withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
93502|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
93503|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
93504|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
93505|NCT02009163|E3|Reported Event|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
93506|NCT02009163|E2|Reported Event|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week .
93537|NCT02008617|P2|Participant Flow|Preservative Free Normal Saline|"Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline~Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline"
93994|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
93507|NCT02009163|E1|Reported Event|SPD489 (Open-label Period)|SPD489 treatment was taken orally once daily at approximately 7:00 AM. All participants began treatment with SPD489 at the lowest dose level (30mg) during the 4-week open-label dose-optimization period. After 1 week of treatment at 30mg, all participants were titrated to the next dose level (50mg). After 1 week of treatment at 50mg, all participants were titrated to the highest dose level (70mg), as tolerated and as clinically indicated. After 1 week of treatment at the highest dose, the participant could have been down-titrated to 50mg; no further dose adjustments were permitted. The optimal daily dose of 50 or 70mg achieved during dose-optimization was maintained throughout the 8-week dose-maintenance period. The total time of the open-label period was 12 weeks.
93508|NCT02008942|B1|Baseline|All Study Participants|All patients that received at least 1 dose of study drug
93509|NCT02008942|P2|Participant Flow|Enteric Coated (EC) Aspirin First, Then PL2200 Aspirin|"First Intervention Period:~EC aspirin: 325 mg aspirin; once per day for 10 days~(after 2-week washout period)~Second Intervention Period:~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days"
93510|NCT02008942|P1|Participant Flow|PL2200 Aspirin First, Then Enteric Coated (EC) Aspirin|"First Intervention Period:~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days~(after 2-week washout period)~Second Intervention Period:~EC aspirin: 325 mg aspirin; once per day for 10 days"
93511|NCT02008942|O2|Outcome|Enteric-coated Aspirin Caplets|"Enteric-coated aspirin caplets~Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 10 days"
93512|NCT02008942|O1|Outcome|PL2200 Aspirin Capsules|"PL2200 Aspirin Capsules~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days"
93513|NCT02008942|E2|Reported Event|Enteric-coated Aspirin Caplets|"Enteric-coated aspirin caplets~Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 10 days"
93514|NCT02008942|E1|Reported Event|PL2200 Aspirin Capsules|"PL2200 Aspirin Capsules~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days"
93515|NCT02008682|B3|Baseline|Total|Total of all reporting groups
93516|NCT02008682|B2|Baseline|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
93517|NCT02008682|B1|Baseline|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
93518|NCT02008682|P2|Participant Flow|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
93519|NCT02008682|P1|Participant Flow|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
93520|NCT02008682|O2|Outcome|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
93521|NCT02008682|O1|Outcome|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
93522|NCT02008682|O2|Outcome|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
93523|NCT02008682|O1|Outcome|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
93524|NCT02008682|O2|Outcome|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
93525|NCT02008682|O1|Outcome|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
93526|NCT02008682|O2|Outcome|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
93527|NCT02008682|O1|Outcome|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
93528|NCT02008682|O2|Outcome|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
93529|NCT02008682|O1|Outcome|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
93530|NCT02008682|O2|Outcome|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
93531|NCT02008682|O1|Outcome|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
93532|NCT02008682|E2|Reported Event|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
93533|NCT02008682|E1|Reported Event|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
93534|NCT02008617|B3|Baseline|Total|Total of all reporting groups
93535|NCT02008617|B2|Baseline|Preservative Free Normal Saline|"Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline~Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline"
93536|NCT02008617|B1|Baseline|Study Drug|"Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000~Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000"
93538|NCT02008617|P1|Participant Flow|Study Drug|"Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000~Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000"
93539|NCT02008617|O2|Outcome|Preservative Free Normal Saline|"Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline~Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline"
93540|NCT02008617|O1|Outcome|Study Drug|"Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000~Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000"
93541|NCT02008617|O2|Outcome|Preservative Free Normal Saline|"Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline~Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline"
93542|NCT02008617|O1|Outcome|Study Drug|"Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000~Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000"
93543|NCT02008617|O2|Outcome|Preservative Free Normal Saline|"Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline~Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline"
93544|NCT02008617|O1|Outcome|Study Drug|"Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000~Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000"
93545|NCT02008617|O2|Outcome|Preservative Free Normal Saline|"Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline~Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline"
93546|NCT02008617|O1|Outcome|Study Drug|"Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000~Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000"
93547|NCT02008617|E2|Reported Event|Preservative Free Normal Saline|"Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline~Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline"
93548|NCT02008617|E1|Reported Event|Study Drug|"Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000~Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000"
93549|NCT02008526|B4|Baseline|Total|Total of all reporting groups
93550|NCT02008526|B3|Baseline|Assessment Only (AO)|During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.
93551|NCT02008526|B2|Baseline|TXT-Auto|"Group 2: Gay-specific, Theory-based Text Messages Transmitted by Automation (TXT-Auto)~Participants assigned to this group receive automatic text-messages.~Following the initial welcome message, participants receive five pre-written messages per day sent on a predetermined schedule.~During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.~Text Messages Transmitted by Automation (TXT-Auto): Participants receive five gay-specific, theory-based pre-written messages per day sent on a predetermined schedule. During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days."
93552|NCT02008526|B1|Baseline|TXT-PHE|"Gay-specific, Theory-based Text Messages Transmitted by Peer Health Educators (TXT-PHE)~Interactive and tailored to the needs of the individual participant. PHEs initiate text messages to participants and also respond to participant-initiated queries and participant responses to the PHE messages.~Participants receive five pre-written messages per day. Participants who respond to the pre-written text messages or initiate queries or requests for support are sent additional messages back.~During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.~Text Messages Transmitted by Peer Health Educators (TXT-PHE): Text messages are transmitted and responded to in real time, at the peak hours of high-risk activities. Participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days."
93553|NCT02008526|P3|Participant Flow|Assessment Only (AO)|During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.
93554|NCT02008526|P2|Participant Flow|TXT-Auto|"Group 2: Gay-specific, Theory-based Text Messages Transmitted by Automation (TXT-Auto)~Participants assigned to this group receive automatic text-messages.~Following the initial welcome message, participants receive five pre-written messages per day sent on a predetermined schedule.~During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.~Text Messages Transmitted by Automation (TXT-Auto): Participants receive five gay-specific, theory-based pre-written messages per day sent on a predetermined schedule. During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days."
93555|NCT02008526|P1|Participant Flow|TXT-PHE|"Gay-specific, Theory-based Text Messages Transmitted by Peer Health Educators (TXT-PHE)~Interactive and tailored to the needs of the individual participant. PHEs initiate text messages to participants and also respond to participant-initiated queries and participant responses to the PHE messages.~Participants receive five pre-written messages per day. Participants who respond to the pre-written text messages or initiate queries or requests for support are sent additional messages back.~During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.~Text Messages Transmitted by Peer Health Educators (TXT-PHE): Text messages are transmitted and responded to in real time, at the peak hours of high-risk activities. Participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days."
93556|NCT02008526|O3|Outcome|Assessment Only (AO)|During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.
94375|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
93557|NCT02008526|O2|Outcome|TXT-Auto|"Group 2: Gay-specific, Theory-based Text Messages Transmitted by Automation (TXT-Auto)~Participants assigned to this group receive automatic text-messages.~Following the initial welcome message, participants receive five pre-written messages per day sent on a predetermined schedule.~During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.~Text Messages Transmitted by Automation (TXT-Auto): Participants receive five gay-specific, theory-based pre-written messages per day sent on a predetermined schedule. During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days."
93558|NCT02008526|O1|Outcome|TXT-PHE|"Gay-specific, Theory-based Text Messages Transmitted by Peer Health Educators (TXT-PHE)~Interactive and tailored to the needs of the individual participant. PHEs initiate text messages to participants and also respond to participant-initiated queries and participant responses to the PHE messages.~Participants receive five pre-written messages per day. Participants who respond to the pre-written text messages or initiate queries or requests for support are sent additional messages back.~During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.~Text Messages Transmitted by Peer Health Educators (TXT-PHE): Text messages are transmitted and responded to in real time, at the peak hours of high-risk activities. Participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days."
93559|NCT02008526|O3|Outcome|Assessment Only (AO)|During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.
93560|NCT02008526|O2|Outcome|TXT-Auto|"Group 2: Gay-specific, Theory-based Text Messages Transmitted by Automation (TXT-Auto)~Participants assigned to this group receive automatic text-messages.~Following the initial welcome message, participants receive five pre-written messages per day sent on a predetermined schedule.~During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.~Text Messages Transmitted by Automation (TXT-Auto): Participants receive five gay-specific, theory-based pre-written messages per day sent on a predetermined schedule. During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days."
93561|NCT02008526|O1|Outcome|TXT-PHE|"Gay-specific, Theory-based Text Messages Transmitted by Peer Health Educators (TXT-PHE)~Interactive and tailored to the needs of the individual participant. PHEs initiate text messages to participants and also respond to participant-initiated queries and participant responses to the PHE messages.~Participants receive five pre-written messages per day. Participants who respond to the pre-written text messages or initiate queries or requests for support are sent additional messages back.~During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.~Text Messages Transmitted by Peer Health Educators (TXT-PHE): Text messages are transmitted and responded to in real time, at the peak hours of high-risk activities. Participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days."
93562|NCT02008526|E3|Reported Event|Assessment Only (AO)|During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.
93563|NCT02008526|E2|Reported Event|TXT-Auto|"Group 2: Gay-specific, Theory-based Text Messages Transmitted by Automation (TXT-Auto)~Participants assigned to this group receive automatic text-messages.~Following the initial welcome message, participants receive five pre-written messages per day sent on a predetermined schedule.~During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.~Text Messages Transmitted by Automation (TXT-Auto): Participants receive five gay-specific, theory-based pre-written messages per day sent on a predetermined schedule. During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days."
93564|NCT02008526|E1|Reported Event|TXT-PHE|"Gay-specific, Theory-based Text Messages Transmitted by Peer Health Educators (TXT-PHE)~Interactive and tailored to the needs of the individual participant. PHEs initiate text messages to participants and also respond to participant-initiated queries and participant responses to the PHE messages.~Participants receive five pre-written messages per day. Participants who respond to the pre-written text messages or initiate queries or requests for support are sent additional messages back.~During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.~Text Messages Transmitted by Peer Health Educators (TXT-PHE): Text messages are transmitted and responded to in real time, at the peak hours of high-risk activities. Participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days."
93565|NCT02008227|B3|Baseline|Total|Total of all reporting groups
93566|NCT02008227|B2|Baseline|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93567|NCT02008227|B1|Baseline|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93568|NCT02008227|P2|Participant Flow|Atezolizumab|Atezolizumab 1200 milligrams (mg) was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93569|NCT02008227|P1|Participant Flow|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93570|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93995|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
93571|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93572|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93573|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93574|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93575|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93576|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93577|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93578|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93579|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93580|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93581|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93582|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93583|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93584|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93585|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93586|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93587|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93588|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93589|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93590|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93591|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93592|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93593|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93594|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93595|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93596|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93597|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93598|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93599|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93600|NCT02008227|O1|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93601|NCT02008227|O1|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93602|NCT02008227|O1|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93603|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93604|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93605|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93606|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93607|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93608|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93609|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93610|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93611|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93612|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93613|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93614|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93615|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93616|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93617|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93618|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93619|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93620|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93621|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93622|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93623|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93624|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93625|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93626|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93627|NCT02008227|E2|Reported Event|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93628|NCT02008227|E1|Reported Event|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
93629|NCT02007954|B1|Baseline|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
93630|NCT02007954|P1|Participant Flow|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
93631|NCT02007954|O1|Outcome|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
93632|NCT02007954|O1|Outcome|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
93633|NCT02007954|O1|Outcome|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
93642|NCT02007863|B1|Baseline|Umbilical Cord Blood + Chemotherapy|"Umbilical Cord Blood Transfusion: Following the administration of the preparative therapy, all subjects will undergo UCB transplantation. Umbilical Cord Blood Transfusion will occur on Day 0~Fludarabine: Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days –13 through –9 for a total of 5 doses. Fludarabine will not be dose adjusted for body weight.~Busulfan: Busulfan IV (Busulfex) will be administered IV every 6 hours on days -8 through -5 for a total of 16 doses. Seizure prophylaxis prior to first dose of busulfan till Day -3 will be administered.~Melphalan: Melphalan 45 mg/m2/day will be administered over 60 minutes intravenous infusion on Days –4 through –2 for a total of 3 doses."
93634|NCT02007954|O1|Outcome|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
93635|NCT02007954|O1|Outcome|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
93636|NCT02007954|O1|Outcome|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
93637|NCT02007954|O1|Outcome|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
93638|NCT02007954|O1|Outcome|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
93639|NCT02007954|O1|Outcome|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
93640|NCT02007954|O1|Outcome|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
93641|NCT02007954|E1|Reported Event|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
93699|NCT02007512|O3|Outcome|Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93996|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
93643|NCT02007863|P1|Participant Flow|Umbilical Cord Blood + Chemotherapy|"Umbilical Cord Blood Transfusion: Following the administration of the preparative therapy, all subjects will undergo UCB transplantation. Umbilical Cord Blood Transfusion will occur on Day 0~Fludarabine: Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days –13 through –9 for a total of 5 doses. Fludarabine will not be dose adjusted for body weight.~Busulfan: Busulfan IV (Busulfex) will be administered IV every 6 hours on days -8 through -5 for a total of 16 doses. Seizure prophylaxis prior to first dose of busulfan till Day -3 will be administered.~Melphalan: Melphalan 45 mg/m2/day will be administered over 60 minutes intravenous infusion on Days –4 through –2 for a total of 3 doses."
93644|NCT02007863|O1|Outcome|Umbilical Cord Blood + Chemotherapy|"Umbilical Cord Blood Transfusion: Following the administration of the preparative therapy, all subjects will undergo UCB transplantation. Umbilical Cord Blood Transfusion will occur on Day 0~Fludarabine: Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days –13 through –9 for a total of 5 doses. Fludarabine will not be dose adjusted for body weight.~Busulfan: Busulfan IV (Busulfex) will be administered IV every 6 hours on days -8 through -5 for a total of 16 doses. Seizure prophylaxis prior to first dose of busulfan till Day -3 will be administered.~Melphalan: Melphalan 45 mg/m2/day will be administered over 60 minutes intravenous infusion on Days –4 through –2 for a total of 3 doses."
93645|NCT02007863|E1|Reported Event|Umbilical Cord Blood + Chemotherapy|"Umbilical Cord Blood Transfusion: Following the administration of the preparative therapy, all subjects will undergo UCB transplantation. Umbilical Cord Blood Transfusion will occur on Day 0~Fludarabine: Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days –13 through –9 for a total of 5 doses. Fludarabine will not be dose adjusted for body weight.~Busulfan: Busulfan IV (Busulfex) will be administered IV every 6 hours on days -8 through -5 for a total of 16 doses. Seizure prophylaxis prior to first dose of busulfan till Day -3 will be administered.~Melphalan: Melphalan 45 mg/m2/day will be administered over 60 minutes intravenous infusion on Days –4 through –2 for a total of 3 doses."
93646|NCT02007577|B3|Baseline|Total|Total of all reporting groups
93647|NCT02007577|B2|Baseline|Placebo|"Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner~Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner"
93648|NCT02007577|B1|Baseline|Salsalate 3500mg in 2 Divided Doses a Day|"Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner~salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner"
93649|NCT02007577|P2|Participant Flow|Placebo|"Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner~Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner"
93650|NCT02007577|P1|Participant Flow|Salsalate 3500mg in 2 Divided Doses a Day|"Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner~salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner"
93651|NCT02007577|O2|Outcome|Placebo|"Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner~Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner"
93652|NCT02007577|O1|Outcome|Salsalate 3500mg in 2 Divided Doses a Day|"Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner~salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner"
93653|NCT02007577|O2|Outcome|Placebo|"Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner~Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner"
93654|NCT02007577|O1|Outcome|Salsalate 3500mg in 2 Divided Doses a Day|"Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner~salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner"
93655|NCT02007577|E2|Reported Event|Placebo|"Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner~Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner"
93656|NCT02007577|E1|Reported Event|Salsalate 3500mg in 2 Divided Doses a Day|"Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner~salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner"
93657|NCT02007512|B5|Baseline|Total|Total of all reporting groups
93658|NCT02007512|B4|Baseline|Cohort 2: Placebo + Exemestane 25 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93659|NCT02007512|B3|Baseline|Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93660|NCT02007512|B2|Baseline|Cohort 1: Placebo + Exemestane 25 mg|Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93661|NCT02007512|B1|Baseline|Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg|Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
94376|NCT02004886|O4|Outcome|Placebo|Placebo
93662|NCT02007512|P4|Participant Flow|Cohort 2: Placebo + Exemestane 25 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93663|NCT02007512|P3|Participant Flow|Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93664|NCT02007512|P2|Participant Flow|Cohort 1: Placebo + Exemestane 25 mg|Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93665|NCT02007512|P1|Participant Flow|Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg|Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93666|NCT02007512|O4|Outcome|Cohort 2: Placebo + Exemestane 25 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93667|NCT02007512|O3|Outcome|Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93668|NCT02007512|O2|Outcome|Cohort 1: Placebo + Exemestane 25 mg|Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93669|NCT02007512|O1|Outcome|Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg|Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93670|NCT02007512|O4|Outcome|Cohort 2: Placebo + Exemestane 25 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93671|NCT02007512|O3|Outcome|Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93672|NCT02007512|O2|Outcome|Cohort 1: Placebo + Exemestane 25 mg|Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93673|NCT02007512|O1|Outcome|Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg|Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93748|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
93674|NCT02007512|O4|Outcome|Cohort 2: Placebo + Exemestane 25 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93675|NCT02007512|O3|Outcome|Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93676|NCT02007512|O2|Outcome|Cohort 1: Placebo + Exemestane 25 mg|Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93677|NCT02007512|O1|Outcome|Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg|Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93678|NCT02007512|O4|Outcome|Cohort 2: Placebo + Exemestane 25 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93679|NCT02007512|O3|Outcome|Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93680|NCT02007512|O2|Outcome|Cohort 1: Placebo + Exemestane 25 mg|Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93681|NCT02007512|O1|Outcome|Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg|Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93682|NCT02007512|O4|Outcome|Cohort 2: Placebo + Exemestane 25 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93683|NCT02007512|O3|Outcome|Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93684|NCT02007512|O2|Outcome|Cohort 1: Placebo + Exemestane 25 mg|Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93685|NCT02007512|O1|Outcome|Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg|Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93749|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93805|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93686|NCT02007512|O4|Outcome|Cohort 2: Placebo + Exemestane 25 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93687|NCT02007512|O3|Outcome|Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93688|NCT02007512|O2|Outcome|Cohort 1: Placebo + Exemestane 25 mg|Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93689|NCT02007512|O1|Outcome|Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg|Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93690|NCT02007512|O1|Outcome|Enzalutamide 160 mg|Participants received enzalutamide 160 mg dose orally, once daily, either in double blind treatment period or in open label treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after the last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93691|NCT02007512|O2|Outcome|Exemestane 50 mg|Participants received exemestane 50 mg dose orally, once daily until disease progression or permanent treatment discontinuation, either in double blind treatment period or in open label treatment period. Participants were followed-up until 30 days after the last dose of study drug, the date of death, or before initiation of a new antitumor treatment, whichever occurred first.
93692|NCT02007512|O1|Outcome|Exemestane 25 mg|Participants received exemestane 25 mg dose orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after the last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93693|NCT02007512|O1|Outcome|Enzalutamide 160 mg|Participants received enzalutamide 160 mg dose orally, once daily, either in double blind treatment period or in open label treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after the last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93694|NCT02007512|O4|Outcome|Cohort 2: Placebo + Exemestane 25 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93695|NCT02007512|O3|Outcome|Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93696|NCT02007512|O2|Outcome|Cohort 1: Placebo + Exemestane 25 mg|Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93697|NCT02007512|O1|Outcome|Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg|Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93698|NCT02007512|O4|Outcome|Cohort 2: Placebo + Exemestane 25 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93750|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93880|NCT02007278|O2|Outcome|Glimepiride and Metformin|Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
93700|NCT02007512|O2|Outcome|Cohort 1: Placebo + Exemestane 25 mg|Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93701|NCT02007512|O1|Outcome|Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg|Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93702|NCT02007512|O4|Outcome|Cohort 2: Placebo + Exemestane 25 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93703|NCT02007512|O3|Outcome|Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93704|NCT02007512|O2|Outcome|Cohort 1: Placebo + Exemestane 25 mg|Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93705|NCT02007512|O1|Outcome|Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg|Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93706|NCT02007512|O4|Outcome|Cohort 2: Placebo + Exemestane 25 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93707|NCT02007512|O3|Outcome|Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93708|NCT02007512|O2|Outcome|Cohort 1: Placebo + Exemestane 25 mg|Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93709|NCT02007512|O1|Outcome|Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg|Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93710|NCT02007512|O4|Outcome|Cohort 2: Placebo + Exemestane 25 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93711|NCT02007512|O3|Outcome|Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93751|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
94241|NCT02005211|B5|Baseline|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
93712|NCT02007512|O2|Outcome|Cohort 1: Placebo + Exemestane 25 mg|Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93713|NCT02007512|O1|Outcome|Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg|Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93714|NCT02007512|O4|Outcome|Cohort 2: Placebo + Exemestane 25 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93715|NCT02007512|O3|Outcome|Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93716|NCT02007512|O2|Outcome|Cohort 1: Placebo + Exemestane 25 mg|Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93717|NCT02007512|O1|Outcome|Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg|Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93718|NCT02007512|O4|Outcome|Cohort 2: Placebo + Exemestane 25 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93719|NCT02007512|O3|Outcome|Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93720|NCT02007512|O2|Outcome|Cohort 1: Placebo + Exemestane 25 mg|Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93721|NCT02007512|O1|Outcome|Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg|Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93722|NCT02007512|E4|Reported Event|Cohort 2: Placebo + Exemestane 25 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93723|NCT02007512|E3|Reported Event|Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93752|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93724|NCT02007512|E2|Reported Event|Cohort 1: Placebo + Exemestane 25 mg|Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93725|NCT02007512|E1|Reported Event|Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg|Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
93726|NCT02007434|B9|Baseline|Total|Total of all reporting groups
93727|NCT02007434|B8|Baseline|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93728|NCT02007434|B7|Baseline|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93729|NCT02007434|B6|Baseline|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93730|NCT02007434|B5|Baseline|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
93731|NCT02007434|B4|Baseline|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
93732|NCT02007434|B3|Baseline|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
93733|NCT02007434|B2|Baseline|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93734|NCT02007434|B1|Baseline|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93735|NCT02007434|P8|Participant Flow|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93736|NCT02007434|P7|Participant Flow|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93737|NCT02007434|P6|Participant Flow|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93738|NCT02007434|P5|Participant Flow|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
93739|NCT02007434|P4|Participant Flow|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
93740|NCT02007434|P3|Participant Flow|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
93741|NCT02007434|P2|Participant Flow|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93742|NCT02007434|P1|Participant Flow|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL (based on Baseline Clinician-Reported Submental Fat Rating Scale [CR-SMFRS] grade 2 or 3, respectively) on Day 0 and a cold compress applied to the treatment area.
93743|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93744|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93745|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93746|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
93747|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
93753|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93754|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
93755|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
93756|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
93757|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93758|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93759|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93760|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93761|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93762|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
93763|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
93764|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
93765|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93766|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93767|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93768|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93769|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93770|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
93771|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
93772|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
93773|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93774|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93775|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93776|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93777|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93778|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
93779|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
93780|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
93781|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93782|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93783|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93784|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93785|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93786|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
93787|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
93788|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
93789|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93790|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93791|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93792|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93793|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93794|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
93795|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
93796|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
93797|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93798|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93799|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93800|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93801|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93802|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
93803|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
93804|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
93990|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
93806|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93807|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93808|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93809|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93810|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
93811|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
93812|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
93813|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93814|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93815|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93816|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 to 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93817|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93818|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
93819|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
93820|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
93821|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93822|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93823|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93824|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93825|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93826|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
93827|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
93828|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
93829|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93830|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93831|NCT02007434|E8|Reported Event|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93991|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
93832|NCT02007434|E7|Reported Event|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93833|NCT02007434|E6|Reported Event|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
93834|NCT02007434|E5|Reported Event|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
93835|NCT02007434|E4|Reported Event|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
93836|NCT02007434|E3|Reported Event|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
93837|NCT02007434|E2|Reported Event|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93838|NCT02007434|E1|Reported Event|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
93839|NCT02007369|B4|Baseline|Total|Total of all reporting groups
93840|NCT02007369|B3|Baseline|Control|No intervention
93841|NCT02007369|B2|Baseline|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.~Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
93842|NCT02007369|B1|Baseline|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks~Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
93843|NCT02007369|P3|Participant Flow|Control|No intervention
93844|NCT02007369|P2|Participant Flow|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks~Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
93845|NCT02007369|P1|Participant Flow|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks~Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
93846|NCT02007369|O3|Outcome|Control|No intervention
93847|NCT02007369|O2|Outcome|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.~Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
93848|NCT02007369|O1|Outcome|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks~Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
93849|NCT02007369|O3|Outcome|Control|No intervention
93850|NCT02007369|O2|Outcome|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.~Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
93851|NCT02007369|O1|Outcome|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks~Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
93852|NCT02007369|O3|Outcome|Control|No intervention
93853|NCT02007369|O2|Outcome|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.~Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
93854|NCT02007369|O1|Outcome|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks~Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
93855|NCT02007369|O3|Outcome|Control|No intervention
93856|NCT02007369|O2|Outcome|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.~Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
93857|NCT02007369|O1|Outcome|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks~Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
93858|NCT02007369|E3|Reported Event|Control|No intervention
93859|NCT02007369|E2|Reported Event|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.~Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
93860|NCT02007369|E1|Reported Event|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks~Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
93861|NCT02007278|B3|Baseline|Total|Total of all reporting groups
93862|NCT02007278|B2|Baseline|Glimepiride and Metformin|Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
93863|NCT02007278|B1|Baseline|Vildagliptin and Metformin|Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
93864|NCT02007278|P2|Participant Flow|Glimepiride and Metformin|Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
93865|NCT02007278|P1|Participant Flow|Vildagliptin and Metformin|Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
93866|NCT02007278|O2|Outcome|Glimepiride and Metformin|Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
93867|NCT02007278|O1|Outcome|Vildagliptin and Metformin|Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
93868|NCT02007278|O2|Outcome|Glimepiride and Metformin|Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
93869|NCT02007278|O1|Outcome|Vildagliptin and Metformin|Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
93870|NCT02007278|O2|Outcome|Glimepiride and Metformin|Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
93871|NCT02007278|O1|Outcome|Vildagliptin and Metformin|Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
93872|NCT02007278|O2|Outcome|Glimepiride and Metformin|Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
93873|NCT02007278|O1|Outcome|Vildagliptin and Metformin|Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
93874|NCT02007278|O2|Outcome|Glimepiride and Metformin|Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
93875|NCT02007278|O1|Outcome|Vildagliptin and Metformin|Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
93876|NCT02007278|O2|Outcome|Glimepiride and Metformin|Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
93877|NCT02007278|O1|Outcome|Vildagliptin and Metformin|Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
93878|NCT02007278|O2|Outcome|Glimepiride and Metformin|Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
93879|NCT02007278|O1|Outcome|Vildagliptin and Metformin|Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
93881|NCT02007278|O1|Outcome|Vildagliptin and Metformin|Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
93882|NCT02007278|E2|Reported Event|Glimepiride and Metformin|Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
93883|NCT02007278|E1|Reported Event|Vildagliptin and Metformin|Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
93884|NCT02007252|B3|Baseline|Total|Total of all reporting groups
93885|NCT02007252|B2|Baseline|Placebo|Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
93886|NCT02007252|B1|Baseline|ACZ885|Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
93887|NCT02007252|P2|Participant Flow|Placebo|Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
93888|NCT02007252|P1|Participant Flow|ACZ885|Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
93889|NCT02007252|O2|Outcome|Placebo|Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
93890|NCT02007252|O1|Outcome|ACZ885|Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
93891|NCT02007252|E2|Reported Event|Placebo|Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
93892|NCT02007252|E1|Reported Event|ACZ885|Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
93893|NCT02007200|B1|Baseline|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
93894|NCT02007200|P1|Participant Flow|Treatment (Soy Isoflavones)|"Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.~55 patients were enrolled. 3 of these patients did not receive treatment."
93895|NCT02007200|O1|Outcome|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
93896|NCT02007200|O1|Outcome|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
93897|NCT02007200|O1|Outcome|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
93898|NCT02007200|O1|Outcome|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
93899|NCT02007200|E1|Reported Event|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
93900|NCT02007096|B3|Baseline|Total|Total of all reporting groups
93901|NCT02007096|B2|Baseline|Non Transabdominal Plane Block|Non Transabdominal Plane Block: Saline injection
93902|NCT02007096|B1|Baseline|Transabdominal Plane Block|Transabdominal Plane Block with 0.25% bupivacaine
93903|NCT02007096|P2|Participant Flow|Non Transabdominal Plane Block|Non Transabdominal Plane Block: Saline injection
93904|NCT02007096|P1|Participant Flow|Transabdominal Plane Block|Transabdominal Plane Block with 0.25% bupivacaine
93905|NCT02007096|O2|Outcome|Non Transabdominal Plane Block|Non Transabdominal Plane Block: Saline injection
93906|NCT02007096|O1|Outcome|Transabdominal Plane Block|Transabdominal Plane Block with 0.25% bupivacaine
93907|NCT02007096|O2|Outcome|Non Transabdominal Plane Block|Non Transabdominal Plane Block: Saline injection
93908|NCT02007096|O1|Outcome|Transabdominal Plane Block|Transabdominal Plane Block with 0.25% bupivacaine
93909|NCT02007096|O2|Outcome|Non Transabdominal Plane Block|Non Transabdominal Plane Block: Saline injection
93910|NCT02007096|O1|Outcome|Transabdominal Plane Block|Transabdominal Plane Block with 0.25% bupivacaine
93911|NCT02007096|O2|Outcome|Non Transabdominal Plane Block|Non Transabdominal Plane Block: Saline injection
93912|NCT02007096|O1|Outcome|Transabdominal Plane Block|Transabdominal Plane Block with 0.25% bupivacaine
93913|NCT02007096|E2|Reported Event|Non Transabdominal Plane Block|Non Transabdominal Plane Block: Saline injection
93914|NCT02007096|E1|Reported Event|Transabdominal Plane Block|Transabdominal Plane Block with 0.25% bupivacaine
93915|NCT02007070|B1|Baseline|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
93916|NCT02007070|P1|Participant Flow|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
93917|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
93918|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
93919|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
93920|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
93921|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
93922|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
93923|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
93924|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
93925|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
93926|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
93927|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
93992|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
93928|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
93929|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
93930|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
93931|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
93932|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
93933|NCT02007070|E1|Reported Event|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
93934|NCT02006888|B4|Baseline|Total|Total of all reporting groups
93935|NCT02006888|B3|Baseline|Placebo|"Placebo~Placebo: Placebo"
93936|NCT02006888|B2|Baseline|IBI-10090 Med Dose|"IBI-10090 med dose~IBI-10090"
93937|NCT02006888|B1|Baseline|IBI-10090 Low Dose|"IBI-10090 low dose~IBI-10090"
93938|NCT02006888|P3|Participant Flow|Placebo|"Placebo~Placebo: Placebo"
93939|NCT02006888|P2|Participant Flow|IBI-10090 Med Dose|"IBI-10090 med dose~IBI-10090"
93940|NCT02006888|P1|Participant Flow|IBI-10090 Low Dose|"IBI-10090 low dose~IBI-10090"
93941|NCT02006888|O3|Outcome|Placebo|"Placebo~Placebo: Placebo"
93942|NCT02006888|O2|Outcome|IBI-10090 Med Dose|"IBI-10090 med dose~IBI-10090"
93943|NCT02006888|O1|Outcome|IBI-10090 Low Dose|"IBI-10090 low dose~IBI-10090"
93944|NCT02006888|E3|Reported Event|Placebo|"Placebo~Placebo: Placebo"
93945|NCT02006888|E2|Reported Event|IBI-10090 Med Dose|"IBI-10090 med dose~IBI-10090"
93946|NCT02006888|E1|Reported Event|IBI-10090 Low Dose|"IBI-10090 low dose~IBI-10090"
93947|NCT02006836|B4|Baseline|Total|Total of all reporting groups
93948|NCT02006836|B3|Baseline|Diabetic 2|For self-control period. The scheme and dose of Continuous Subcutaneous Insulin Infusion (CSII) for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days.
93949|NCT02006836|B2|Baseline|Healthy|For case-control period and for GI measurement. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
93950|NCT02006836|B1|Baseline|Diabetic|For case-control period and for GI measurement. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
93951|NCT02006836|P3|Participant Flow|Self-Control: Diabetic 2|"For self-control period. Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days.~On the 4th to 6th day, patients with a constant dose of insulin did not consume Majia pomelos after meals, and this intervention was defined as blank.~On the 7th to 9th day, patients with the same dose of insulin consumed 100g Majia pomelos after meals (breakfast, lunch and dinner)."
93952|NCT02006836|P2|Participant Flow|Case-Control: Healthy|For case-control period and for GI measurement. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
93953|NCT02006836|P1|Participant Flow|Case-Control: Diabetic|For case-control period and for GI measurement. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
93954|NCT02006836|O2|Outcome|Diabetic 2 - With Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 7th to 9th day with a constant dose of insulin and consumed 100g Majia pomelos after meals (breakfast, lunch and dinner).
93955|NCT02006836|O1|Outcome|Diabetic 2 - Without Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 4th to 6th day with a constant dose of insulin and did not consumed Majia pomelos after meals, and this intervention was defined as blank.
93956|NCT02006836|O2|Outcome|Diabetic 2 - With Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 7th to 9th day with a constant dose of insulin and consumed 100g Majia pomelos after meals (breakfast, lunch and dinner).
93957|NCT02006836|O1|Outcome|Diabetic 2 - Without Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 4th to 6th day with a constant dose of insulin and did not consumed Majia pomelos after meals, and this intervention was defined as blank.
93958|NCT02006836|O2|Outcome|Diabetic 2 - With Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 7th to 9th day with a constant dose of insulin and consumed 100g Majia pomelos after meals (breakfast, lunch and dinner).
93959|NCT02006836|O1|Outcome|Diabetic 2 - Without Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 4th to 6th day with a constant dose of insulin and did not consumed Majia pomelos after meals, and this intervention was defined as blank.
93960|NCT02006836|O2|Outcome|Diabetic 2 - With Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 7th to 9th day with a constant dose of insulin and consumed 100g Majia pomelos after meals (breakfast, lunch and dinner).
93961|NCT02006836|O1|Outcome|Diabetic 2 - Without Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 4th to 6th day with a constant dose of insulin and did not consumed Majia pomelos after meals, and this intervention was defined as blank.
93962|NCT02006836|O2|Outcome|Healthy|For case-control period. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
93963|NCT02006836|O1|Outcome|Diabetic|For case-control period. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
93964|NCT02006836|E4|Reported Event|Diabetic 2 - With Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 7th to 9th day with a constant dose of insulin and consumed 100g Majia pomelos after meals (breakfast, lunch and dinner).
93965|NCT02006836|E3|Reported Event|Diabetic 2 - Without Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 4th to 6th day with a constant dose of insulin and did not consumed Majia pomelos after meals, and this intervention was defined as blank.
93966|NCT02006836|E2|Reported Event|Healthy|On the first test day we utilized 50 g of glucose dissolved in 200 ml water. The second day was washout day. On the third day we used 922 g of Majia pomelos which contained 50 g carbohydrate.This group of volunteers enrolled for the case control period.
93967|NCT02006836|E1|Reported Event|Diabetic|Diabetic patients use oral antidiabetic drugs(metformin or pioglitazone or both) or only life style modification. On the first test day we utilized 50 g of glucose dissolved in 200 ml water. The second day was washout day. On the third day we used 922 g of Majia pomelos which contained 50 g carbohydrate.This group of diabetic patients enrolled for the case control period.
93968|NCT02006732|B5|Baseline|Total|Total of all reporting groups
93969|NCT02006732|B4|Baseline|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
93970|NCT02006732|B3|Baseline|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
93971|NCT02006732|B2|Baseline|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
93972|NCT02006732|B1|Baseline|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
93973|NCT02006732|P4|Participant Flow|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
93974|NCT02006732|P3|Participant Flow|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
93975|NCT02006732|P2|Participant Flow|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
93976|NCT02006732|P1|Participant Flow|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
93977|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
93978|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
93979|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
93980|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
93981|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
93982|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
93983|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
93984|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
93985|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
93986|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
93987|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
93988|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
93989|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
93997|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
93998|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
93999|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
94000|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
94001|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
94002|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
94003|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
94004|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
94005|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
94006|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
94007|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
94008|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
94009|NCT02006732|E4|Reported Event|Tiotropium 5 μg +Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
94010|NCT02006732|E3|Reported Event|Tiotropium 2.5 μg +Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
94011|NCT02006732|E2|Reported Event|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
94012|NCT02006732|E1|Reported Event|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
94013|NCT02006719|B3|Baseline|Total|Total of all reporting groups
94014|NCT02006719|B2|Baseline|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
94015|NCT02006719|B1|Baseline|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
94016|NCT02006719|P2|Participant Flow|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
94017|NCT02006719|P1|Participant Flow|AA4500|Up to 3 injections of 0.58 mg/1 mL collagenase clostridium histolyticum (AA4500), minimum of 21 days apart and home shoulder exercise
94018|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
94019|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
94020|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
94021|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
94022|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
94023|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
94024|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
94025|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
94026|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
94027|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
94028|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
94029|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
94030|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
94031|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
94032|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
94033|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
94034|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
94035|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
94036|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
94037|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
94038|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
94039|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
94040|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
94041|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
94042|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
94043|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
94044|NCT02006719|E2|Reported Event|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
94045|NCT02006719|E1|Reported Event|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
94242|NCT02005211|B4|Baseline|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
94046|NCT02006706|B1|Baseline|Rituximab/Methylprednisolone/MTX|Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
94047|NCT02006706|P1|Participant Flow|Rituximab/Methylprednisolone/Methotrexate (MTX)|Participants received rituximab 1000 milligrams (mg), intravaneously (IV), and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
94048|NCT02006706|O1|Outcome|Rituximab/Methylprednisolone/MTX|Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
94049|NCT02006706|O1|Outcome|Rituximab/Methylprednisolone/MTX|Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
94050|NCT02006706|E1|Reported Event|Rituximab/Methylprednisolone/MTX|Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
94051|NCT02006667|B1|Baseline|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
94052|NCT02006667|P1|Participant Flow|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg per kilogram (mg/kg), IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
94053|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
94054|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
94055|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
94056|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
94057|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
94058|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
94059|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
94060|NCT02006667|E1|Reported Event|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
94061|NCT02006654|B3|Baseline|Total|Total of all reporting groups
94062|NCT02006654|B2|Baseline|Idalopirdine 60 mg (or 30 mg)|"Idalopirdine adjunct to base treatment with an AChEI~Idalopirdine: Once daily, encapsulated tablets, orally"
94063|NCT02006654|B1|Baseline|Placebo|"Placebo adjunct to base treatment with an AChEI~Placebo: Once daily, matching placebo capsules, orally"
94064|NCT02006654|P2|Participant Flow|Idalopirdine 60 mg (or 30 mg)|"Idalopirdine adjunct to base treatment with an ACHEI~Idalopirdine: Once daily, encapsulated tablets, orally"
94065|NCT02006654|P1|Participant Flow|Placebo|"Placebo adjunct to base treatment with an AChEI~Placebo: Once daily, matching placebo capsules, orally"
94066|NCT02006654|O2|Outcome|Idalopirdine 60 mg (or 30 mg)|"Idalopirdine adjunct to base treatment with an AChEI~Idalopirdine: Once daily, encapsulated tablets, orally"
94067|NCT02006654|O1|Outcome|Placebo|"Placebo adjunct to base treatment with an AChEI~Placebo: Once daily, matching placebo capsules, orally"
94068|NCT02006654|O2|Outcome|Idalopirdine 60 mg (or 30 mg)|"Idalopirdine adjunct to base treatment with an AChEI~Idalopirdine: Once daily, encapsulated tablets, orally"
94069|NCT02006654|O1|Outcome|Placebo|"Placebo adjunct to base treatment with an AChEI~Placebo: Once daily, matching placebo capsules, orally"
94070|NCT02006654|O2|Outcome|Idalopirdine 60 mg (or 30 mg)|"Idalopirdine adjunct to base treatment with an AChEI~Idalopirdine: Once daily, encapsulated tablets, orally"
94071|NCT02006654|O1|Outcome|Placebo|"Placebo adjunct to base treatment with an AChEI~Placebo: Once daily, matching placebo capsules, orally"
94072|NCT02006654|O2|Outcome|Idalopirdine 60 mg (or 30 mg)|"Idalopirdine adjunct to base treatment with an AChEI~Idalopirdine: Once daily, encapsulated tablets, orally"
94073|NCT02006654|O1|Outcome|Placebo|"Placebo adjunct to base treatment with an AChEI~Placebo: Once daily, matching placebo capsules, orally"
94074|NCT02006654|O2|Outcome|Idalopirdine 60 mg (or 30 mg)|"Idalopirdine adjunct to base treatment with an AChEI~Idalopirdine: Once daily, encapsulated tablets, orally"
94075|NCT02006654|O1|Outcome|Placebo|"Placebo adjunct to base treatment with an AChEI~Placebo: Once daily, matching placebo capsules, orally"
94076|NCT02006654|O2|Outcome|Idalopirdine 60 mg (or 30 mg)|"Idalopirdine adjunct to base treatment with an AChEI~Idalopirdine: Once daily, encapsulated tablets, orally"
94077|NCT02006654|O1|Outcome|Placebo|"Placebo adjunct to base treatment with an AChEI~Placebo: Once daily, matching placebo capsules, orally"
94078|NCT02006654|O2|Outcome|Idalopirdine 60 mg (or 30 mg)|"Idalopirdine adjunct to base treatment with an AChEI~Idalopirdine: Once daily, encapsulated tablets, orally"
94079|NCT02006654|O1|Outcome|Placebo|"Placebo adjunct to base treatment with an AChEI~Placebo: Once daily, matching placebo capsules, orally"
94080|NCT02006654|O2|Outcome|Idalopirdine 60 mg (or 30 mg)|"Idalopirdine adjunct to base treatment with an AChEI~Idalopirdine: Once daily, encapsulated tablets, orally"
94081|NCT02006654|O1|Outcome|Placebo|"Placebo adjunct to base treatment with an AChEI~Placebo: Once daily, matching placebo capsules, orally"
94082|NCT02006654|O2|Outcome|Idalopirdine 60 mg (or 30 mg)|"Idalopirdine adjunct to base treatment with an ACHEI~Idalopirdine: Once daily, encapsulated tablets, orally"
94083|NCT02006654|O1|Outcome|Placebo|"Placebo adjunct to base treatment with an AChEI~Placebo: Once daily, matching placebo capsules, orally"
94084|NCT02006654|O2|Outcome|Idalopirdine 60 mg (or 30 mg)|"Idalopirdine adjunct to base treatment with an ACHEI~Idalopirdine: Once daily, encapsulated tablets, orally"
94085|NCT02006654|O1|Outcome|Placebo|"Placebo adjunct to base treatment with an AChEI~Placebo: Once daily, matching placebo capsules, orally"
94086|NCT02006654|O2|Outcome|Idalopirdine 60 mg (or 30 mg)|"Idalopirdine adjunct to base treatment with an ACHEI~Idalopirdine: Once daily, encapsulated tablets, orally"
94087|NCT02006654|O1|Outcome|Placebo|"Placebo adjunct to base treatment with an AChEI~Placebo: Once daily, matching placebo capsules, orally"
94088|NCT02006654|E2|Reported Event|Idalopirdine 60 mg|"Idalopirdine adjunct to base treatment with an AChEI~Idalopirdine: Once daily, encapsulated tablets, orally"
94089|NCT02006654|E1|Reported Event|Placebo|"Placebo adjunct to base treatment with an AChEI~Placebo: Once daily, matching placebo capsules, orally"
94090|NCT02006641|B4|Baseline|Total|Total of all reporting groups
94091|NCT02006641|B3|Baseline|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94092|NCT02006641|B2|Baseline|Idalopirdine 10 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94093|NCT02006641|B1|Baseline|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
94094|NCT02006641|P3|Participant Flow|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94095|NCT02006641|P2|Participant Flow|Idalopirdine 10 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94096|NCT02006641|P1|Participant Flow|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
94097|NCT02006641|O3|Outcome|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94098|NCT02006641|O2|Outcome|Idalopirdine 10 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94099|NCT02006641|O1|Outcome|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
94100|NCT02006641|O3|Outcome|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94101|NCT02006641|O2|Outcome|Idalopirdine 10 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94102|NCT02006641|O1|Outcome|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
94103|NCT02006641|O3|Outcome|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94104|NCT02006641|O2|Outcome|Idalopirdine 10 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94105|NCT02006641|O1|Outcome|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
94106|NCT02006641|O3|Outcome|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94107|NCT02006641|O2|Outcome|Idalopirdine 10 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94108|NCT02006641|O1|Outcome|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
94109|NCT02006641|O3|Outcome|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94110|NCT02006641|O2|Outcome|Idalopirdine 10 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94111|NCT02006641|O1|Outcome|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
94112|NCT02006641|O3|Outcome|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94113|NCT02006641|O2|Outcome|Idalopirdine 10 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94114|NCT02006641|O1|Outcome|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
94115|NCT02006641|O3|Outcome|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94116|NCT02006641|O2|Outcome|Idalopirdine 10 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94117|NCT02006641|O1|Outcome|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
94118|NCT02006641|O3|Outcome|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94119|NCT02006641|O2|Outcome|Idalopirdine 10 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94120|NCT02006641|O1|Outcome|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
94121|NCT02006641|O3|Outcome|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94122|NCT02006641|O2|Outcome|Idalopirdine 10 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94123|NCT02006641|O1|Outcome|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
94124|NCT02006641|O3|Outcome|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94125|NCT02006641|O2|Outcome|Idalopirdine 10 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94126|NCT02006641|O1|Outcome|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
94127|NCT02006641|O3|Outcome|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94128|NCT02006641|O2|Outcome|Idalopirdine 10 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94129|NCT02006641|O1|Outcome|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
94130|NCT02006641|E3|Reported Event|Idalopirdine 30 mg|"Idalopirdine adjunct to 20 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94131|NCT02006641|E2|Reported Event|Idalopirdine 10 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
94132|NCT02006641|E1|Reported Event|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
94133|NCT02006407|B1|Baseline|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).~Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.~MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)~Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
94134|NCT02006407|P1|Participant Flow|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).~Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.~MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)~Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
94135|NCT02006407|O1|Outcome|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).~Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.~MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)~Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
94136|NCT02006407|O1|Outcome|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).~Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.~MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)~Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
94137|NCT02006407|O1|Outcome|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).~Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.~MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)~Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
94138|NCT02006407|E1|Reported Event|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).~Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.~MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)~Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
94139|NCT02006342|B3|Baseline|Total|Total of all reporting groups
94140|NCT02006342|B2|Baseline|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.~Regular Insulin"
94243|NCT02005211|B3|Baseline|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
94141|NCT02006342|B1|Baseline|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.~Insulin Glargine~Regular Insulin"
94142|NCT02006342|P2|Participant Flow|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.~Regular Insulin"
94143|NCT02006342|P1|Participant Flow|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.~Insulin Glargine~Regular Insulin"
94144|NCT02006342|O2|Outcome|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.~Regular Insulin"
94145|NCT02006342|O1|Outcome|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.~Insulin Glargine~Regular Insulin"
94146|NCT02006342|O2|Outcome|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.~Regular Insulin"
94147|NCT02006342|O1|Outcome|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.~Insulin Glargine~Regular Insulin"
94148|NCT02006342|O2|Outcome|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.~Regular Insulin"
94149|NCT02006342|O1|Outcome|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.~Insulin Glargine~Regular Insulin"
94150|NCT02006342|O2|Outcome|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.~Regular Insulin"
94151|NCT02006342|O1|Outcome|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.~Insulin Glargine~Regular Insulin"
94152|NCT02006342|O2|Outcome|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.~Regular Insulin"
94153|NCT02006342|O1|Outcome|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.~Insulin Glargine~Regular Insulin"
94154|NCT02006342|E2|Reported Event|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.~Regular Insulin"
94155|NCT02006342|E1|Reported Event|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.~Insulin Glargine~Regular Insulin"
94156|NCT02006108|B1|Baseline|Feraheme|"Intravenous injection of Feraheme, 5 mg Fe/kg~Interventions:~Drug: Feraheme Procedure: MR Scan~Feraheme: Therapeutic classification: iron preparations. Use: Off-label use of ultrasmall paramagnetic iron nanoparticle as contrast agent for magnetic resonance imaging~MRI-GE Healthcare 3 Tesla magnet: All patients will undergo"
94157|NCT02006108|P1|Participant Flow|Feraheme|"Intravenous injection of Feraheme, 5 mg Fe/kg~Interventions:~Drug: Feraheme Procedure: MR Scan~Feraheme: Therapeutic classification: iron preparations. Use: Off-label use of ultrasmall paramagnetic iron nanoparticle as contrast agent for magnetic resonance imaging~MRI-GE Healthcare 3 Tesla magnet: All patients will undergo"
94158|NCT02006108|O1|Outcome|Feraheme|"Intravenous injection of Feraheme, 5 mg Fe/kg~Interventions:~Drug: Feraheme Procedure: MR Scan~Feraheme: Therapeutic classification: iron preparations. Use: Off-label use of ultrasmall paramagnetic iron nanoparticle as contrast agent for magnetic resonance imaging~MRI-GE Healthcare 3 Tesla magnet: All patients will undergo"
94159|NCT02006108|O1|Outcome|Feraheme|"Intravenous injection of Feraheme, 5 mg Fe/kg~Interventions:~Drug: Feraheme Procedure: MR Scan~Feraheme: Therapeutic classification: iron preparations. Use: Off-label use of ultrasmall paramagnetic iron nanoparticle as contrast agent for magnetic resonance imaging~MRI-GE Healthcare 3 Tesla magnet: All patients will undergo"
94160|NCT02006108|E1|Reported Event|Feraheme|"Intravenous injection of Feraheme, 5 mg Fe/kg~Interventions:~Drug: Feraheme Procedure: MR Scan~Feraheme: Therapeutic classification: iron preparations. Use: Off-label use of ultrasmall paramagnetic iron nanoparticle as contrast agent for magnetic resonance imaging~MRI-GE Healthcare 3 Tesla magnet: All patients will undergo"
94161|NCT02005692|B1|Baseline|DynaSense Sensor|All subjects who successfully completed the study.
94162|NCT02005692|P1|Participant Flow|DynaSense Sensor|"All patients enrolled in the study were prescribed a Q2 hour (every 2 hour) turning protocol, as per the standard guidelines of the study site. In the context of the study, caregivers were not asked to turn patients any more or less frequently than what the study site's standard turning protocol required.~The rate of compliance with prescribed turning protocols was measured using the DynaSense System."
94163|NCT02005692|O1|Outcome|DynaSense Sensor|All subjects who successfully completed the study.
94164|NCT02005692|O1|Outcome|DynaSense Sensor|All subjects enrolled in the study.
94165|NCT02005692|E1|Reported Event|DynaSense Sensor|All subjects enrolled in the study.
94166|NCT02005601|B3|Baseline|Total|Total of all reporting groups
94167|NCT02005601|B2|Baseline|Control|"Patients will receive 0mg of duloxetine~Placebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
94244|NCT02005211|B2|Baseline|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
94245|NCT02005211|B1|Baseline|Placebo Part 1|Placebo Part 1 - SAD
94246|NCT02005211|P7|Participant Flow|Placebo Part 2|Placebo Part 2 - MAD
94168|NCT02005601|B1|Baseline|Duloxetine|"Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.~Duloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
94169|NCT02005601|P2|Participant Flow|Control|"Patients will receive 0mg of duloxetine~Placebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
94170|NCT02005601|P1|Participant Flow|Duloxetine|"Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.~Duloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
94171|NCT02005601|O2|Outcome|Control|"Patients will receive 0mg of duloxetine~Placebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
94172|NCT02005601|O1|Outcome|Duloxetine|"Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.~Duloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
94173|NCT02005601|O2|Outcome|Control|"Patients will receive 0mg of duloxetine~Placebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
94174|NCT02005601|O1|Outcome|Duloxetine|"Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.~Duloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
94175|NCT02005601|O2|Outcome|Control|"Patients will receive 0mg of duloxetine~Placebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
94176|NCT02005601|O1|Outcome|Duloxetine|"Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.~Duloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
94177|NCT02005601|E2|Reported Event|Control|"Patients will receive 0mg of duloxetine~Placebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
94178|NCT02005601|E1|Reported Event|Duloxetine|"Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.~Duloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
94179|NCT02005562|B3|Baseline|Total|Total of all reporting groups
94180|NCT02005562|B2|Baseline|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94181|NCT02005562|B1|Baseline|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94182|NCT02005562|P2|Participant Flow|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94183|NCT02005562|P1|Participant Flow|Mycophenolate Mofetil, Adapted Dose|Participants received mycophenolate mofetil (MMF), 3 grams (g), tablets or capsules, orally (PO), every 12 hours (q12h) adapted to mycophenolic acid (MPA) by area under the curve (AUC) on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a 2 hour postdose (C2) level equal to (=) 1000 to 1500 nanograms per milliliter (ng/mL) from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 milligrams (mg), intravenously (IV), on Day -1 or Day 0, and 0.5 mg per kilogram (mg/kg), PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-interleukin (IL)-2R, per the investigator's discretion.
94184|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94185|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94186|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94187|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94188|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94189|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94190|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94191|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94192|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94193|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94194|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94195|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94196|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94197|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94247|NCT02005211|P6|Participant Flow|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
94248|NCT02005211|P5|Participant Flow|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
94249|NCT02005211|P4|Participant Flow|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
94198|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94199|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94200|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94201|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94202|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94203|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94204|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94205|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94206|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94207|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94208|NCT02005562|E2|Reported Event|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94209|NCT02005562|E1|Reported Event|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
94250|NCT02005211|P3|Participant Flow|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
94251|NCT02005211|P2|Participant Flow|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
94252|NCT02005211|P1|Participant Flow|Placebo Part 1|Placebo Part 1 - SAD
94210|NCT02005549|B1|Baseline|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
94211|NCT02005549|P1|Participant Flow|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 milligrams/kilogram (mg/kg) intravenously (IV), followed by docetaxel 75 mg per square meter (mg/m^2) IV on Day 1 and capecitabine 950 mg/m^2 orally (PO) twice daily (BID) within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
94212|NCT02005549|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
94213|NCT02005549|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
94214|NCT02005549|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
94215|NCT02005549|E1|Reported Event|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
94216|NCT02005536|B1|Baseline|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
94217|NCT02005536|P1|Participant Flow|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
94218|NCT02005536|O1|Outcome|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
94219|NCT02005536|O1|Outcome|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
94220|NCT02005536|O1|Outcome|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
94221|NCT02005536|O1|Outcome|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
94222|NCT02005536|O1|Outcome|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
94223|NCT02005536|E1|Reported Event|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
94224|NCT02005484|B1|Baseline|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
94225|NCT02005484|P1|Participant Flow|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
94226|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
94227|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
94228|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
94229|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
94230|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
94231|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
94232|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
94233|NCT02005484|E1|Reported Event|Trastuzumab Monotherapy|Participants received trastuzumab via IV infusion once weekly at an initial dose of 4 mg/kg at Visit 1, and 2 mg/kg at each subsequent visit for a maximum of 33 visits.
94234|NCT02005393|B1|Baseline|FICE Image Acquisition Followed by NBI Image Acquisition|"Images Captured with FICE Image Acquisition System immediately followed by Image Acquisition with NBI~FICE Image Acquisition System: Images Captured with FICE Device"
94235|NCT02005393|P1|Participant Flow|FICE Image Acquisition Followed by NBI Image Acquisition|"Images Captured with FICE Image Acquisition immediately followed by NBI Image Acquisition~FICE Image Acquisition System: Images Captured with FICE Device"
94236|NCT02005393|O1|Outcome|FICE Image Acquisition Followed by NBI Image Acquisition|"Images Captured with FICE Image Acquisition System, immediately followed by NBI Image Acquisition; always in that order.~FICE Image Acquisition System: Images Captured with FICE Device"
94237|NCT02005393|E1|Reported Event|FICE Image Acquisition Followed by NBI Image Acquisition|"Images Captured with FICE Image Acquisition System, immediately followed by Image Acquisition with NBI~FICE Image Acquisition System: Images Captured with FICE Device~No AE's"
94238|NCT02005211|B8|Baseline|Total|Total of all reporting groups
94239|NCT02005211|B7|Baseline|Placebo Part 2|Placebo Part 2 - MAD
94240|NCT02005211|B6|Baseline|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
94268|NCT02005211|O4|Outcome|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
94269|NCT02005211|O3|Outcome|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
94270|NCT02005211|O2|Outcome|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
94271|NCT02005211|O1|Outcome|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
94272|NCT02005211|O5|Outcome|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
94273|NCT02005211|O4|Outcome|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
94274|NCT02005211|O3|Outcome|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
94275|NCT02005211|O2|Outcome|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
94276|NCT02005211|O1|Outcome|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
94277|NCT02005211|E7|Reported Event|Placebo Part 2|Placebo Part 2 - MAD
94278|NCT02005211|E6|Reported Event|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
94279|NCT02005211|E5|Reported Event|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
94280|NCT02005211|E4|Reported Event|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
94281|NCT02005211|E3|Reported Event|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
94282|NCT02005211|E2|Reported Event|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
94283|NCT02005211|E1|Reported Event|Placebo Part 1|Placebo Part 1 - SAD
94284|NCT02005029|B3|Baseline|Total|Total of all reporting groups
94285|NCT02005029|B2|Baseline|Erythromycin Then Placebo|One time IV dose of 100 mg Erythromycin followed by 1 time IV dose of placebo (after 2 week washout)
94286|NCT02005029|B1|Baseline|Placebo First Then Erythromycin|One time IV dose of placebo followed by 1 time IV dose of Erythromycin (after 2 week washout)
94287|NCT02005029|P2|Participant Flow|Erythromycin Then Placebo|One time IV dose of 100 mg Erythromycin followed by 1 time IV dose of placebo (after 2 week washout)
94288|NCT02005029|P1|Participant Flow|Placebo First Then Erythromycin|One time IV dose of placebo followed by 1 time IV dose of Erythromycin (after 2 week washout)
94289|NCT02005029|O2|Outcome|Placebo|Cmax of plasma levodopa after placebo
94290|NCT02005029|O1|Outcome|Erythromycin|Cmax of plasma levodopa after erythromycin
94291|NCT02005029|O2|Outcome|Placebo|
94292|NCT02005029|O1|Outcome|Erythromycin|
94293|NCT02005029|O2|Outcome|Placebo|AIMS after receiving placebo
94294|NCT02005029|O1|Outcome|Erythromycin|AIMS after receiving erythromycin
94295|NCT02005029|O2|Outcome|Placebo|TUAG (fast speed) after placebo
94296|NCT02005029|O1|Outcome|Erythromycin|TUAG (fast speed) after erythromycin
94297|NCT02005029|O2|Outcome|Placebo|TUAG (comfortable speed) after placebo
94298|NCT02005029|O1|Outcome|Erythromycin|TUAG (comfortable speed) after erythromycin
94299|NCT02005029|O2|Outcome|Placebo|Mean CGS for all participants receiving placebo
94300|NCT02005029|O1|Outcome|Erythromycin|Mean CGS for all participants receiving erythromycin
94301|NCT02005029|O2|Outcome|Placebo|Five times sit-to-stand for all participants receiving placebo
94302|NCT02005029|O1|Outcome|Erythromycin|Five times sit-to-stand for all participants receiving erythromycin
94303|NCT02005029|O2|Outcome|Placebo|Mean time for right hand after placebo
94304|NCT02005029|O1|Outcome|Erythromycin|Mean time for right hand after erythromycin
94305|NCT02005029|O2|Outcome|Placebo|Mean time for right hand after placebo
94306|NCT02005029|O1|Outcome|Erythromycin|Mean time for right hand after erythromycin
94307|NCT02005029|O2|Outcome|Placebo|Area under the curve 0-4 hours for plasma levodopa after placebo
94308|NCT02005029|O1|Outcome|Erythromycin|Area under the curve 0-4 hours for plasma levodopa after erythromycin
94309|NCT02005029|O2|Outcome|Placebo|Mean gastric emptying time for participants receiving placebo
94310|NCT02005029|O1|Outcome|Erythromycin|Mean gastric emptying time for participants receiving erythromycin
94311|NCT02005029|E2|Reported Event|Placebo|Participants who received a one time dose of placebo
94312|NCT02005029|E1|Reported Event|Erythromycin|Participants who received a one time dose of IV erythromycin
94313|NCT02004990|B1|Baseline|Single Cleansing Procedure of 10% Povidone Iodine Cleansing|"10% povidone iodine cleansing~Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application"
94314|NCT02004990|P1|Participant Flow|Single Cleansing Procedure of 10% Povidone Iodine Cleansing|"10% povidone iodine cleansing~Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application"
94315|NCT02004990|O1|Outcome|Single Cleansing Procedure of 10% Povidone Iodine Cleansing|"10% povidone iodine cleansing~Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application"
94316|NCT02004990|O1|Outcome|Single Cleansing Procedure of 10% Povidone Iodine Cleansing|"10% povidone iodine cleansing~Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application"
94317|NCT02004990|E1|Reported Event|Single Cleansing Procedure of 10% Povidone Iodine Cleansing|"10% povidone iodine cleansing~Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application"
94318|NCT02004977|B3|Baseline|Total|Total of all reporting groups
94319|NCT02004977|B2|Baseline|Comparison Arm|the role of the comparison arm (schools) is to maintain usual breakfast program at school
94320|NCT02004977|B1|Baseline|Intervention Arm|"The role of the intervention arm (schools) is to improve access to the school breakfast program~Improve access to the school breakfast program: Access to the school breakfast program is defined as implementation of a grab-n-go cart outside of the school cafeteria, policy change allowing students to eat in the hallway and marketing of the program. in rural high schools."
94321|NCT02004977|P2|Participant Flow|Comparison Arm|the role of the comparison arm (schools) is to maintain usual breakfast program at school
94377|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
94378|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
94322|NCT02004977|P1|Participant Flow|Intervention Arm|"The role of the intervention arm (schools) is to improve access to the school breakfast program~Improve access to the school breakfast program: Access to the school breakfast program is defined as implementation of a grab-n-go cart outside of the school cafeteria, policy change allowing students to eat in the hallway and marketing of the program. in rural high schools."
94323|NCT02004977|O2|Outcome|Comparison Arm|the role of the comparison arm (schools) is to maintain usual breakfast program at school
94324|NCT02004977|O1|Outcome|Intervention Arm|"The role of the intervention arm (schools) is to improve access to the school breakfast program~Improve access to the school breakfast program: Access to the school breakfast program is defined as implementation of a grab-n-go cart outside of the school cafeteria, policy change allowing students to eat in the hallway and marketing of the program. in rural high schools."
94325|NCT02004977|O2|Outcome|Comparison Arm|the role of the comparison arm (schools) is to maintain usual breakfast program at school
94326|NCT02004977|O1|Outcome|Intervention Arm|"The role of the intervention arm (schools) is to improve access to the school breakfast program~Improve access to the school breakfast program: Access to the school breakfast program is defined as implementation of a grab-n-go cart outside of the school cafeteria, policy change allowing students to eat in the hallway and marketing of the program. in rural high schools."
94327|NCT02004977|O2|Outcome|Comparison Arm|the role of the comparison arm (schools) is to maintain usual breakfast program at school
94328|NCT02004977|O1|Outcome|Intervention Arm|"The role of the intervention arm (schools) is to improve access to the school breakfast program~Improve access to the school breakfast program: Access to the school breakfast program is defined as implementation of a grab-n-go cart outside of the school cafeteria, policy change allowing students to eat in the hallway and marketing of the program. in rural high schools."
94329|NCT02004977|O2|Outcome|Comparison Arm|the role of the comparison arm (schools) is to maintain usual breakfast program at school
94330|NCT02004977|O1|Outcome|Intervention Arm|"The role of the intervention arm (schools) is to improve access to the school breakfast program~Improve access to the school breakfast program: Access to the school breakfast program is defined as implementation of a grab-n-go cart outside of the school cafeteria, policy change allowing students to eat in the hallway and marketing of the program. in rural high schools."
94331|NCT02004977|O2|Outcome|Comparison Arm|the role of the comparison arm (schools) is to maintain usual breakfast program at school
94332|NCT02004977|O1|Outcome|Intervention Arm|"The role of the intervention arm (schools) is to improve access to the school breakfast program~Improve access to the school breakfast program: Access to the school breakfast program is defined as implementation of a grab-n-go cart outside of the school cafeteria, policy change allowing students to eat in the hallway and marketing of the program. in rural high schools."
94333|NCT02004977|E2|Reported Event|Comparison Arm|the role of the comparison arm (schools) is to maintain usual breakfast program at school
94334|NCT02004977|E1|Reported Event|Intervention Arm|"The role of the intervention arm (schools) is to improve access to the school breakfast program~Improve access to the school breakfast program: Access to the school breakfast program is defined as implementation of a grab-n-go cart outside of the school cafeteria, policy change allowing students to eat in the hallway and marketing of the program. in rural high schools."
94335|NCT02004886|B5|Baseline|Total|Total of all reporting groups
94336|NCT02004886|B4|Baseline|Placebo|Placebo
94337|NCT02004886|B3|Baseline|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
94338|NCT02004886|B2|Baseline|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
94339|NCT02004886|B1|Baseline|MK-0893 (40 mg)|MK-0893 40-mg, once daily
94340|NCT02004886|P4|Participant Flow|Placebo|Placebo
94341|NCT02004886|P3|Participant Flow|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
94342|NCT02004886|P2|Participant Flow|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
94343|NCT02004886|P1|Participant Flow|MK-0893 (40 mg)|MK-0893 40-mg, once daily
94344|NCT02004886|O4|Outcome|Placebo|Placebo
94345|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
94346|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
94347|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
94348|NCT02004886|O4|Outcome|Placebo|Placebo
94349|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
94350|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
94351|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
94352|NCT02004886|O4|Outcome|Placebo|Placebo
94353|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
94354|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
94355|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
94356|NCT02004886|O4|Outcome|Placebo|Placebo
94357|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
94358|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
94359|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
94360|NCT02004886|O4|Outcome|Placebo|Placebo
94361|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
94362|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
94363|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
94364|NCT02004886|O4|Outcome|Placebo|Placebo
94365|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
94366|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
94367|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
94368|NCT02004886|O4|Outcome|Placebo|Placebo
94369|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
94370|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
94371|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
94372|NCT02004886|O4|Outcome|Placebo|Placebo
94373|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
94374|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
94381|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
94382|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
94383|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
94384|NCT02004886|O4|Outcome|Placebo|Placebo
94385|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
94386|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
94387|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
94388|NCT02004886|E4|Reported Event|Placebo|Placebo
94389|NCT02004886|E3|Reported Event|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
94390|NCT02004886|E2|Reported Event|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
94391|NCT02004886|E1|Reported Event|MK-0893 (40 mg)|MK-0893 40-mg, once daily
94392|NCT02004873|B1|Baseline|Micra Study Enrollments|All subjects enrolled in the Micra study
94393|NCT02004873|P1|Participant Flow|Micra Pacemaker Implant|All subjects who attempted Micra implant procedure
94394|NCT02004873|O1|Outcome|Micra Subjects With Usable M-PREP Data|Subjects implanted with Micra who had usable M-PREP test(s) at 3-month and/or 6-month visits.
94395|NCT02004873|O1|Outcome|Micra Subjects With 6-month PCT Data|Subjects implanted with Micra who had paired ventricular capture management PCT and auto decrement PCT data available at the 6-month visit.
94396|NCT02004873|O1|Outcome|Micra Subjects With Implant and 6-month PCT Data|Subjects implanted with Micra who had paired implant and 6-month auto decrement PCT values (0.24 ms), or who had a system modification or alternative device implant prior to 6 months due to elevated threshold.
94397|NCT02004873|O1|Outcome|Micra Pacemaker Implant|All subjects who attempted Micra implant procedure
94398|NCT02004873|E1|Reported Event|Micra Pacemaker Implant|All subjects who attempted Micra implant procedure
94399|NCT02004847|B3|Baseline|Total|Total of all reporting groups
94400|NCT02004847|B2|Baseline|Low Intensity (LI) vs Control|"PSO-CT02 device: Light wavelength 453nm, low intensity, compared to contralateral untreated control plaque on the same patient.~PSO-CT02: The PSO-CT02 device is a non CE marked investigational medical device that is worn on the affected skin area where it irradiates the Psoriasis plaque for 30 minutes with blue light."
94401|NCT02004847|B1|Baseline|High Intensity (HI) vs Control|"PSO-CT02 device: Light wavelength 453nm, high intensity, compared to contralateral untreated control plaque on the same patient.~PSO-CT02: The PSO-CT02 device is a non CE marked investigational medical device that is worn on the affected skin area where it irradiates the Psoriasis plaque for 30 minutes with blue light."
94402|NCT02004847|P2|Participant Flow|Low Intensity (LI) vs. Control|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
94403|NCT02004847|P1|Participant Flow|High Intensity (HI) vs. Control|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
94404|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
94405|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
94406|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
94407|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
94408|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
94409|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
94410|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
94411|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
94412|NCT02004847|O4|Outcome|Control (LI)|Contralateral untreated control plaque on the same patient.
94413|NCT02004847|O3|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity
94414|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient
94415|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity
94416|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
94417|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
94418|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
94419|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
94420|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
94421|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
94422|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
94423|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
94424|NCT02004847|O4|Outcome|Control (LI)|Contralateral untreated control plaque on the same patient
94425|NCT02004847|O3|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
94426|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient
94427|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
94428|NCT02004847|O4|Outcome|Control (LI)|Contralateral untreated control plaque on the same patient.
94429|NCT02004847|O3|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
94430|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient
94431|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
94432|NCT02004847|O4|Outcome|Control (LI)|Contralateral untreated control plaque on the same patient.
94433|NCT02004847|O3|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity
94434|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient
94435|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity
94436|NCT02004847|O2|Outcome|Control (LI)|Contralateral untreated control plaque on the same patient.
94437|NCT02004847|O1|Outcome|Low Intensity|PSO-CT02 device: Light wavelength 453nm, low intensity
94438|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient.
94439|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity
94440|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient.
94441|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity
94442|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient.
94443|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity
94444|NCT02004847|E2|Reported Event|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
94445|NCT02004847|E1|Reported Event|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
94446|NCT02004262|B7|Baseline|Total|Total of all reporting groups
94447|NCT02004262|B6|Baseline|2nd-line Cohort: Chemotherapy|
94448|NCT02004262|B5|Baseline|2nd-line Cohort: CRS-207|
94449|NCT02004262|B4|Baseline|2nd-line Cohort: Cy/GVAX + CRS-207|
94450|NCT02004262|B3|Baseline|Primary Cohort: Chemotherapy|
94451|NCT02004262|B2|Baseline|Primary Cohort: CRS-207|
94452|NCT02004262|B1|Baseline|Primary Cohort: Cy/GVAX + CRS-207|
94453|NCT02004262|P6|Participant Flow|2nd-line Cohort: Chemotherapy|"Investigator’s choice of one of the following: gemcitabine (1000 mg/m^2) administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle; capecitabine (1000 mg/m^2) administered orally twice a day on Days 1 through 14 of a 21-day cycle; fluorouracil with or without leucovorin (2400 mg^m2) administered by IV infusion over 46 hours on Days 1 and 15 of a 28-day cycle; irinotecan (150 mg/m^2) administered by IV infusion on Days 1 and 15 of a 28-day cycle; or erlotinib (100 mg) administered orally once a day for a 21-day cycle.~The 2nd-line Cohort comprised those subjects who received and failed 1 prior chemotherapy regimen administered for pancreatic cancer in the metastatic setting."
94454|NCT02004262|P5|Participant Flow|2nd-line Cohort: CRS-207|"CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16.~The 2nd-line Cohort comprised those subjects who received and failed 1 prior chemotherapy regimen administered for pancreatic cancer in the metastatic setting."
94455|NCT02004262|P4|Participant Flow|2nd-line Cohort: Cy/GVAX + CRS-207|"200 mg/m^2 Cy administered by IV infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.~The 2nd-line Cohort comprised those subjects who received and failed 1 prior chemotherapy regimen administered for pancreatic cancer in the metastatic setting."
94456|NCT02004262|P3|Participant Flow|Primary Cohort: Chemotherapy|"Investigator’s choice of one of the following: gemcitabine (1000 mg/m^2) administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle; capecitabine (1000 mg/m^2) administered orally twice a day on Days 1 through 14 of a 21-day cycle; fluorouracil with or without leucovorin (2400 mg^m2) administered by IV infusion over 46 hours on Days 1 and 15 of a 28-day cycle; irinotecan (150 mg/m^2) administered by IV infusion on Days 1 and 15 of a 28-day cycle; or erlotinib (100 mg) administered orally once a day for a 21-day cycle.~The Primary Cohort comprised those subjects who failed at least 1 gemcitabine-based regimen administered for pancreatic cancer in any setting and failed at least 2 prior chemotherapy regimens administered for pancreatic cancer in the metastatic setting."
94457|NCT02004262|P2|Participant Flow|Primary Cohort: CRS-207|"CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16.~The Primary Cohort comprised those subjects who failed at least 1 gemcitabine-based regimen administered for pancreatic cancer in any setting and failed at least 2 prior chemotherapy regimens administered for pancreatic cancer in the metastatic setting."
94458|NCT02004262|P1|Participant Flow|Primary Cohort: Cy/GVAX + CRS-207|"200 mg per square meter (mg/m^2) cyclophosphamide (Cy) administered by intravenous (IV) infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (GVAX, 5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 colony forming units [CFU]) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.~The Primary Cohort comprised those subjects who failed at least 1 gemcitabine-based regimen administered for pancreatic cancer in any setting and failed at least 2 prior chemotherapy regimens administered for pancreatic cancer in the metastatic setting."
94459|NCT02004262|O3|Outcome|Pooled Cohort: Chemotherapy|"Investigator’s choice of one of the following: gemcitabine (1000 mg/m^2) administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle; capecitabine (1000 mg/m^2) administered orally twice a day on Days 1 through 14 of a 21-day cycle; fluorouracil with or without leucovorin (2400 mg^m2) administered by IV infusion over 46 hours on Days 1 and 15 of a 28-day cycle; irinotecan (150 mg/m^2) administered by IV infusion on Days 1 and 15 of a 28-day cycle; or erlotinib (100 mg) administered orally once a day for a 21-day cycle.~Participants from both the Primary and 2nd-Line Cohorts receiving at least 1 chemotherapy treatment were combined to form the Pooled Cohort."
94460|NCT02004262|O2|Outcome|Pooled Cohort: CRS-207|"CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16.~Participants from both the Primary and 2nd-Line Cohorts receiving at least 1 CRS-207 treatment were combined to form the Pooled Cohort."
94461|NCT02004262|O1|Outcome|Pooled Cohort: Cy/GVAX + CRS-207|"200 mg/m^2 Cy administered by IV infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.~Participants from both the Primary and 2nd-Line Cohorts receiving at least 1 Cy/GVAX + CRS-207 treatment were combined to form the Pooled Cohort."
94462|NCT02004262|O3|Outcome|2nd-line Cohort: Chemotherapy|
94463|NCT02004262|O2|Outcome|2nd-line Cohort: CRS-207|
94464|NCT02004262|O1|Outcome|2nd-line Cohort: Cy/GVAX + CRS-207|
94465|NCT02004262|O3|Outcome|Primary Cohort: Chemotherapy|
94466|NCT02004262|O2|Outcome|Primary Cohort: CRS-207|
94467|NCT02004262|O1|Outcome|Primary Cohort: Cy/GVAX + CRS-207|
94468|NCT02004262|O3|Outcome|Primary Cohort: Chemotherapy|
94469|NCT02004262|O2|Outcome|Primary Cohort: CRS-207|
94470|NCT02004262|O1|Outcome|Primary Cohort: Cy/GVAX + CRS-207|
94471|NCT02004262|E3|Reported Event|Pooled Cohort: Chemotherapy|"Investigator’s choice of one of the following: gemcitabine (1000 mg/m^2) administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle; capecitabine (1000 mg/m^2) administered orally twice a day on Days 1 through 14 of a 21-day cycle; fluorouracil with or without leucovorin (2400 mg^m2) administered by IV infusion over 46 hours on Days 1 and 15 of a 28-day cycle; irinotecan (150 mg/m^2) administered by IV infusion on Days 1 and 15 of a 28-day cycle; or erlotinib (100 mg) administered orally once a day for a 21-day cycle.~Participants from both the Primary and 2nd-Line Cohorts receiving at least 1 chemotherapy treatment were combined to form the Pooled Cohort."
94472|NCT02004262|E2|Reported Event|Pooled Cohort: CRS-207|"CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16.~Participants from both the Primary and 2nd-Line Cohorts receiving at least 1 CRS-207 treatment were combined to form the Pooled Cohort."
94473|NCT02004262|E1|Reported Event|Pooled Cohort: Cy/GVAX + CRS-207|"200 mg/m^2 Cy administered by IV infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.~Participants from both the Primary and 2nd-Line Cohorts receiving at least 1 Cy/GVAX + CRS-207 treatment were combined to form the Pooled Cohort."
94474|NCT02004236|B4|Baseline|Total|Total of all reporting groups
94475|NCT02004236|B3|Baseline|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
94476|NCT02004236|B2|Baseline|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
94477|NCT02004236|B1|Baseline|tRNS Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
94478|NCT02004236|P3|Participant Flow|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
94479|NCT02004236|P2|Participant Flow|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
94480|NCT02004236|P1|Participant Flow|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
94481|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
94482|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
94483|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
94484|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
94485|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
94486|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
94487|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
94488|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
94489|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
94490|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
94491|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
94492|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
94493|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
94494|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
94495|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
94496|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
94497|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
94498|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
94499|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
94500|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
94501|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
94502|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
94503|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
94504|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
94505|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
94506|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
94507|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
94508|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
94509|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
94510|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
94511|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
94512|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
94513|NCT02004236|O1|Outcome|tRNS Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
94514|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
94515|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
94516|NCT02004236|O1|Outcome|tRNS Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
94517|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
94518|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
94519|NCT02004236|O1|Outcome|tRNS Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
94520|NCT02004236|E3|Reported Event|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
94521|NCT02004236|E2|Reported Event|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
94522|NCT02004236|E1|Reported Event|tRNS Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
94523|NCT02004158|B1|Baseline|Positive Psychology|Positive psychology intervention
94524|NCT02004158|P1|Participant Flow|Positive Psychology|Positive psychology intervention
94525|NCT02004158|O2|Outcome|Positive Psychology|Positive psychology intervention (8 week data)
94526|NCT02004158|O1|Outcome|Positive Psychology|Positive psychology intervention (Baseline data)
94527|NCT02004158|O1|Outcome|Positive Psychology|Positive psychology intervention
94528|NCT02004158|O1|Outcome|Positive Psychology|Positive psychology intervention
94529|NCT02004158|O1|Outcome|Positive Psychology|Positive psychology intervention
94530|NCT02004158|E1|Reported Event|Positive Psychology|Positive psychology intervention
94531|NCT02004132|B1|Baseline|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
94532|NCT02004132|P1|Participant Flow|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
94533|NCT02004132|O1|Outcome|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
94534|NCT02004132|O1|Outcome|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
94535|NCT02004132|O1|Outcome|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
94536|NCT02004132|E1|Reported Event|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
94537|NCT02004093|B3|Baseline|Total|Total of all reporting groups
94538|NCT02004093|B2|Baseline|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
94539|NCT02004093|B1|Baseline|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER: 1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
94540|NCT02004093|P2|Participant Flow|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
94541|NCT02004093|P1|Participant Flow|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 milligrams (mg) intravenously (IV) on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/square meters (m^2) IV on Day 1 and carboplatin target area under the curve (AUC) 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
94542|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
94543|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
94544|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
94545|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
94546|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
94547|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
94548|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
94549|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen17 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
94550|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
94551|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
94552|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
94571|NCT02003963|B2|Baseline|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
94596|NCT02003638|P2|Participant Flow|Placebo|Placebo taken orally every day for 12 weeks
94597|NCT02003638|P1|Participant Flow|Niacin|Niacin titrated up to 6 grams taken orally every day for 12 weeks
94553|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
94554|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
94555|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
94556|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
94557|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
94558|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
94559|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER: 1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
94560|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
94561|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off
94562|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
94563|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
94564|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
94565|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
94566|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
94567|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
94568|NCT02004093|E2|Reported Event|Chemotherapy|Participants received chemotherapy with either Paclitaxel or Gemcitabine. Paclitaxel dosage was 175 mg/m2 IV every 3 weeks for 6 cycles followed by Carboplatin AUC of 5; Gemcitabine dosage was 1000 mg/ m2 IV on day 1 and 8 of each cycle for 6 cycles followed by Carboplatin AUC of 4, IV every 3 weeks for 6 cycles.
94569|NCT02004093|E1|Reported Event|Chemotherapy + Pertuzumab|Participants received loading dose of 840mg IV Pertuzumab, followed by 420 mg IV every 3 weeks (for a total of 17 cycles), along with chemotherapy with either Paclitaxel or Gemcitabine. Paclitaxel dosage was 175 mg/m2 IV every 3 weeks for 6 cycles, followed by Carboplatin AUC of 5; Gemcitabine dosage was 1000 mg/m2 IV on day 1 and 8 of each cycle for 6 cycles followed by Carboplatin AUC of 4, IV every 3 weeks for 6 cycles.
94572|NCT02003963|B1|Baseline|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
94573|NCT02003963|P2|Participant Flow|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
94574|NCT02003963|P1|Participant Flow|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently.~Klub Kinect: Dance Central and Just Dance are a series of rhythm games developed by Harmonix Music Systems exclusively for the Xbox 360 Kinect. The Dance Central suite of games (Dance Central 1, 2, and 3) and Just Dance will be played on the Xbox 360+ Kinect gaming console, which employs whole body movement using an infrared sensor that tracks body movements such that an external controller device is not required. The player performs dance moves demonstrated by on-screen characters and set to popular music, with a choice of over 650 dance moves, 90 dance routines, and over 300 songs."
94575|NCT02003963|O2|Outcome|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
94576|NCT02003963|O1|Outcome|Exergame Intervention|Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently.
94577|NCT02003963|O2|Outcome|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
94578|NCT02003963|O1|Outcome|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
94579|NCT02003963|O2|Outcome|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
94580|NCT02003963|O1|Outcome|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
94581|NCT02003963|O2|Outcome|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
94582|NCT02003963|O1|Outcome|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
94583|NCT02003963|O2|Outcome|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
94584|NCT02003963|O1|Outcome|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
94585|NCT02003963|O2|Outcome|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
94586|NCT02003963|O1|Outcome|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
94587|NCT02003963|O2|Outcome|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
94588|NCT02003963|O1|Outcome|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
94589|NCT02003963|O2|Outcome|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
94590|NCT02003963|O1|Outcome|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
94591|NCT02003963|E2|Reported Event|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
94592|NCT02003963|E1|Reported Event|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
94593|NCT02003638|B3|Baseline|Total|Total of all reporting groups
94594|NCT02003638|B2|Baseline|Placebo|Placebo taken orally every day for 12 weeks
94595|NCT02003638|B1|Baseline|Niacin|Niacin titrated up to 6 grams taken orally every day for 12 weeks
94598|NCT02003638|O2|Outcome|Placebo|Placebo taken orally every day for 12 weeks
94599|NCT02003638|O1|Outcome|Niacin|Niacin titrated up to 6 grams taken orally every day for 12 weeks
94600|NCT02003638|E2|Reported Event|Placebo|Placebo taken orally every day for 12 weeks
94601|NCT02003638|E1|Reported Event|Niacin|Niacin titrated up to 6 grams taken orally every day for 12 weeks
94602|NCT02003534|B1|Baseline|0.15% Brimonidine Tartrate|0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
94603|NCT02003534|P1|Participant Flow|0.15% Brimonidine Tartrate|0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
94604|NCT02003534|O1|Outcome|0.15% Brimonidine Tartrate|0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
94605|NCT02003534|E1|Reported Event|0.15% Brimonidine Tartrate|0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
94606|NCT02003404|B1|Baseline|Abdominal Skin Barrier Peel Force|Three commerical barrier materials, SoftFlex, FlexWear and FlexTend barrier were peeled from control or peristomal abdominal skin after a set period at a set rate.
94607|NCT02003404|P1|Participant Flow|Abdominal Skin Barrier Peel Force|"Barrier materials were attached and peeled off control and peristomal abdominal skin.~Three commercial barrier materials (SoftFlex, FlexWear and FlexTend) were peeled from control or peristomal abdominal skin after a set period at a set rate."
94608|NCT02003404|O2|Outcome|Peristomal Skin Barrier Peel Force|Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from peristomal skin after a set period at a set rate.
94609|NCT02003404|O1|Outcome|Control Abdominal Skin Barrier Peel Force|Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from abdominal skin after a set period at a set rate.
94610|NCT02003404|E2|Reported Event|Peristomal Skin Barrier Peel Force|Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from peristomal skin after a set period at a set rate.
94611|NCT02003404|E1|Reported Event|Control Abdominal Skin Barrier Peel Force|Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from abdominal skin after a set period at a set rate.
94612|NCT02003391|B3|Baseline|Total|Total of all reporting groups
94613|NCT02003391|B2|Baseline|Beta-blocker|4 weeks of beta-blocker monotherapy, followed by 4 weeks of travoprost/timolol
94614|NCT02003391|B1|Baseline|DuoTrav|Travoprost/timolol for 8 weeks
94615|NCT02003391|P2|Participant Flow|Beta-blocker|4 weeks of beta-blocker monotherapy, followed by 4 weeks of travoprost/timolol
94616|NCT02003391|P1|Participant Flow|DuoTrav|Travoprost/timolol for 8 weeks
94617|NCT02003391|O2|Outcome|Beta-blocker|Beta-blocker monotherapy for 4 weeks
94618|NCT02003391|O1|Outcome|DuoTrav|Travoprost/timolol for 4 weeks
94619|NCT02003391|O2|Outcome|Beta-blocker|Beta-blocker monotherapy for 4 weeks
94620|NCT02003391|O1|Outcome|DuoTrav|Travoprost/timolol for 4 weeks
94621|NCT02003391|O2|Outcome|Beta-blocker|Beta-blocker monotherapy for 4 weeks
94622|NCT02003391|O1|Outcome|DuoTrav|Travoprost/timolol for 4 weeks
94623|NCT02003391|E2|Reported Event|Beta-blocker|4 weeks of beta-blocker monotherapy, followed by 4 weeks of travoprost/timolol
94624|NCT02003391|E1|Reported Event|DuoTrav|Travoprost/timolol for 8 weeks
94625|NCT02003365|B4|Baseline|Total|Total of all reporting groups
94626|NCT02003365|B3|Baseline|TCA IR 40 mg|Single 1 mL IA injection
94627|NCT02003365|B2|Baseline|FX006 40 mg|Single 3 mL IA injection
94628|NCT02003365|B1|Baseline|FX006 10 mg|Single 3 mL IA injection
94629|NCT02003365|P3|Participant Flow|TCA IR 40 mg|10 subjects received TCA IR 40 mg as a single 1 mL IA injection
94630|NCT02003365|P2|Participant Flow|FX006 40 mg|30 Subjects received FX006 40 mg as a single 3 mL IA injection
94631|NCT02003365|P1|Participant Flow|FX006 10 mg|10 subjects received FX006 10 mg as a single 3 mL IA injection
94632|NCT02003365|O3|Outcome|TCA IR 40 mg|Single 1 mL IA injection.
94633|NCT02003365|O2|Outcome|FX006 40 mg|Single 3 mL IA injection.
94634|NCT02003365|O1|Outcome|FX006 10 mg|Single 3 mL IA injection.
94635|NCT02003365|O3|Outcome|TCA IR 40 mg|Single 1 mL IA injection.
94636|NCT02003365|O2|Outcome|FX006 40 mg|Single 3 mL IA injection.
94637|NCT02003365|O1|Outcome|FX006 10 mg|Single 3 mL IA injection.
94638|NCT02003365|E3|Reported Event|TCA IR|Single 1 mL IA injection
94639|NCT02003365|E2|Reported Event|FX006 40 mg|Single 3 mL IA injection
94640|NCT02003365|E1|Reported Event|FX006 10 mg|Single 3 mL IA injection
94641|NCT02003352|B1|Baseline|Functional Neurological Rehabilitation|"Functional Neurological and physical/vestibular rehabilitation strategies~Functional Neurological Rehabilitation: Functional Neurological Rehabilitation Includes vestibular rehabilitation and physical rehabilitation. Vestibular rehabilitation utilizes strategies that involves movement of the head and eyes at various speeds and directions while the subject looks at a target. Physical rehabilitation involves exercises to increase mobility and increase strength.~The study population consisted of 98 combat veterans who had suffered aT BI with PTSD, referred to our study by Veteran’s groups. All subjects were male with a mean age of 39 years with a minimum age of 20 years and a maximum age of 60 years.They all met the inclusion requirements and did not have any of the exclusion requirements."
94642|NCT02003352|P1|Participant Flow|Functional Neurological Rehabilitation|"Functional Neurological and physical/vestibular rehabilitation strategies~Functional Neurological Rehabilitation: Functional Neurological Rehabilitation Includes vestibular rehabilitation and physical rehabilitation. Vestibular rehabilitation utilizes strategies that involves movement of the head and eyes at various speeds and directions while the subject looks at a target. Physical rehabilitation involves exercises to increase mobility and increase strength."
94643|NCT02003352|O1|Outcome|Functional Neurological Rehabilitation|"Functional Neurological and physical/vestibular rehabilitation strategies~Functional Neurological Rehabilitation: Functional Neurological Rehabilitation Includes vestibular rehabilitation and physical rehabilitation. Vestibular rehabilitation utilizes strategies that involves movement of the head and eyes at various speeds and directions while the subject looks at a target. Physical rehabilitation involves exercises to increase mobility and increase strength."
94644|NCT02003352|E1|Reported Event|Functional Neurological Rehabilitation|"Functional Neurological and physical/vestibular rehabilitation strategies~Functional Neurological Rehabilitation: Functional Neurological Rehabilitation Includes vestibular rehabilitation and physical rehabilitation. Vestibular rehabilitation utilizes strategies that involves movement of the head and eyes at various speeds and directions while the subject looks at a target. Physical rehabilitation involves exercises to increase mobility and increase strength."
94645|NCT02003053|B3|Baseline|Total|Total of all reporting groups
94646|NCT02003053|B2|Baseline|Sham|"In the SHAM group, sham device will be used to train subjects 5 minutes twice a day, seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge.~Inspiratory Muscle Trainer"
94647|NCT02003053|B1|Baseline|Inpsiratory Muscle Training|"In the IMT group, inspiratory muscle training will start with 30% of MIP, for five minutes twice a day with increments of 10 % (absolute) everyday. Supplemental oxygen will be given as needed. The exercise will be done seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge.~Inspiratory Muscle Trainer"
94648|NCT02003053|P2|Participant Flow|Sham|"In the SHAM group, sham device will be used to train subjects 5 minutes twice a day, seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge.~Inspiratory Muscle Trainer"
94649|NCT02003053|P1|Participant Flow|Inspiratory Muscle Training|"In the IMT group, inspiratory muscle training will start with 30% of MIP, for five minutes twice a day with increments of 10 % (absolute) everyday. Supplemental oxygen will be given as needed. The exercise will be done seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge.~Inspiratory Muscle Trainer"
94650|NCT02003053|O2|Outcome|Sham|"In the SHAM group, sham device will be used to train subjects 5 minutes twice a day, seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge.~Inspiratory Muscle Trainer"
94651|NCT02003053|O1|Outcome|Inspiratory Muscle Training|"In the IMT group, inspiratory muscle training will start with 30% of MIP, for five minutes twice a day with increments of 10 % (absolute) everyday. Supplemental oxygen will be given as needed. The exercise will be done seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge.~Inspiratory Muscle Trainer"
94652|NCT02003053|E2|Reported Event|Sham Group|"In the SHAM group, sham device will be used to train subjects 5 minutes twice a day, seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge.~Inspiratory Muscle Trainer"
94653|NCT02003053|E1|Reported Event|Inspiratory Muscle Training Group|"In the IMT group, inspiratory muscle training will start with 30% of MIP, for five minutes twice a day with increments of 10 % (absolute) everyday. Supplemental oxygen will be given as needed. The exercise will be done seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge.~Inspiratory Muscle Trainer"
94654|NCT02003014|B1|Baseline|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
94655|NCT02003014|P1|Participant Flow|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
94656|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
94657|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
94658|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
94659|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
94660|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
94661|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
94662|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
94663|NCT02003014|E1|Reported Event|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
94664|NCT02002936|B1|Baseline|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
94665|NCT02002936|P1|Participant Flow|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
94666|NCT02002936|O1|Outcome|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
94667|NCT02002936|O1|Outcome|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
94668|NCT02002936|O1|Outcome|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
94928|NCT02000622|O1|Outcome|Olaparib 300 mg bd|Olaparib 300 mg bd tablets
94669|NCT02002936|O1|Outcome|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
94670|NCT02002936|O1|Outcome|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
94671|NCT02002936|O1|Outcome|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
94672|NCT02002936|E1|Reported Event|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
94673|NCT02002871|B1|Baseline|Blue Light vs Control|"Light wavelength 453nm, compared to contralateral untreated control plaque on the same patient.~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light. A contralateral eczema area is left untreated and serves as control."
94674|NCT02002871|P1|Participant Flow|Blue Light vs Control|"Light wavelength 453nm, compared to contralateral untreated control plaque on the same patient.~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light. A contralateral eczema area is left untreated and serves as control."
94675|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
94676|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
94677|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
94678|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
94679|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
94680|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
94681|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
94682|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
94683|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
94684|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
94685|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
94686|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
94687|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
94688|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
94689|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
94690|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
94691|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
94692|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
94693|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
94694|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
94695|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
94696|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
94697|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
94698|NCT02002871|E1|Reported Event|Blue Light vs Control|"Light wavelength 453nm, compared to contralateral untreated control plaque on the same patient.~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light. A contralateral eczema area is left untreated and serves as control."
94699|NCT02002702|B4|Baseline|Total|Total of all reporting groups
94700|NCT02002702|B3|Baseline|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
94701|NCT02002702|B2|Baseline|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
94702|NCT02002702|B1|Baseline|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
94703|NCT02002702|P3|Participant Flow|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
94704|NCT02002702|P2|Participant Flow|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
94705|NCT02002702|P1|Participant Flow|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
94706|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
94707|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
94708|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
94709|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
94710|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
94711|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
94712|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
94713|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
94714|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
94715|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
94716|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
94717|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
94718|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
94719|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
94720|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
94721|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
94722|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
94723|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
94724|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
94725|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
94726|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
94727|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
94728|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
94729|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
94730|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
94731|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
94732|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
94733|NCT02002702|E3|Reported Event|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
94734|NCT02002702|E2|Reported Event|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
94735|NCT02002702|E1|Reported Event|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
94736|NCT02002689|B1|Baseline|Sonidegib|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
94737|NCT02002689|P1|Participant Flow|Sonidegib|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
94738|NCT02002689|O1|Outcome|Sonidegib|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
94739|NCT02002689|O1|Outcome|Sonidegib|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
94740|NCT02002689|O1|Outcome|Sonidegib|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
94741|NCT02002689|E1|Reported Event|LDE225|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
94742|NCT02002650|B3|Baseline|Total|Total of all reporting groups
94743|NCT02002650|B2|Baseline|Post-ERCP Group|"Post-ERCP rectal Indomethacin in high-risk patients.~Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not."
94744|NCT02002650|B1|Baseline|Pre-ERCP Group|"Pre-ERCP rectal Indomethacin in all patients.~Pre-operational rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients."
95130|NCT01999218|P2|Participant Flow|Ertugliflozin 15 mg|Ertugliflozin 15 mg QD from Day 1 to Week 104
94745|NCT02002650|P2|Participant Flow|Post-ERCP Group|"Post-ERCP rectal Indomethacin in high-risk patients.~Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not."
94746|NCT02002650|P1|Participant Flow|Pre-ERCP Group|"Pre-ERCP rectal Indomethacin in all patients.~Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients."
94747|NCT02002650|O2|Outcome|Post-ERCP Group|"Post-ERCP rectal Indomethacin for high-risk patients.~Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just for high-risk patients."
94748|NCT02002650|O1|Outcome|Pre-ERCP Group|"Pre-ERCP rectal Indomethacin in all patients.~Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients."
94749|NCT02002650|O2|Outcome|Post-ERCP Group|"Post-ERCP rectal Indomethacin in high-risk patients.~Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not."
94750|NCT02002650|O1|Outcome|Pre-ERCP Group|"Pre-ERCP rectal Indomethacin in all patients.~Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients."
94751|NCT02002650|E2|Reported Event|Post-ERCP Group|"Post-ERCP rectal Indomethacin in high-risk patients.~Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not."
94752|NCT02002650|E1|Reported Event|Pre-ERCP Group|"Pre-ERCP rectal Indomethacin in all patients.~Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients."
94753|NCT02002533|B3|Baseline|Total|Total of all reporting groups
94754|NCT02002533|B2|Baseline|Arm II (Control)|"Patients undergo HEAL comprising nutritional education and suggestions for symptom management over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Educational Intervention: Undergo HEAL~Telephone-Based Intervention: Undergo HEAL"
94755|NCT02002533|B1|Baseline|Arm I (BBT Intervention)|"Patients undergo BBT intervention, comprising insomnia education, stimulus control, discouragement of napping and encouragement of exercise, and sleep compression over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Brief Behavioral Therapy: Undergo BBT intervention~Telephone-Based Intervention: Undergo BBT intervention"
94756|NCT02002533|P2|Participant Flow|Arm II (Control)|"Patients undergo HEAL comprising nutritional education and suggestions for symptom management over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Educational Intervention: Undergo HEAL~Telephone-Based Intervention: Undergo HEAL"
94757|NCT02002533|P1|Participant Flow|Arm I (BBT Intervention)|"Patients undergo BBT intervention, comprising insomnia education, stimulus control, discouragement of napping and encouragement of exercise, and sleep compression over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Brief Behavioral Therapy: Undergo BBT intervention~Telephone-Based Intervention: Undergo BBT intervention"
94758|NCT02002533|O2|Outcome|Arm II (Control)|"Patients undergo HEAL comprising nutritional education and suggestions for symptom management over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Educational Intervention: Undergo HEAL~Telephone-Based Intervention: Undergo HEAL"
94759|NCT02002533|O1|Outcome|Arm I (BBT Intervention)|"Patients undergo BBT intervention, comprising insomnia education, stimulus control, discouragement of napping and encouragement of exercise, and sleep compression over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Brief Behavioral Therapy: Undergo BBT intervention~Telephone-Based Intervention: Undergo BBT intervention"
94760|NCT02002533|O2|Outcome|Arm II (Control)|"Patients undergo HEAL comprising nutritional education and suggestions for symptom management over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Educational Intervention: Undergo HEAL~Telephone-Based Intervention: Undergo HEAL"
94761|NCT02002533|O1|Outcome|Arm I (BBT Intervention)|"Patients undergo BBT intervention, comprising insomnia education, stimulus control, discouragement of napping and encouragement of exercise, and sleep compression over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Brief Behavioral Therapy: Undergo BBT intervention~Telephone-Based Intervention: Undergo BBT intervention"
94762|NCT02002533|O2|Outcome|Arm II (Control)|"Patients undergo HEAL comprising nutritional education and suggestions for symptom management over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Educational Intervention: Undergo HEAL~Telephone-Based Intervention: Undergo HEAL"
94763|NCT02002533|O1|Outcome|Arm I (BBT Intervention)|"Patients undergo BBT intervention, comprising insomnia education, stimulus control, discouragement of napping and encouragement of exercise, and sleep compression over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Brief Behavioral Therapy: Undergo BBT intervention~Telephone-Based Intervention: Undergo BBT intervention"
94764|NCT02002533|O2|Outcome|Arm II (Control)|"Patients undergo HEAL comprising nutritional education and suggestions for symptom management over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Educational Intervention: Undergo HEAL~Telephone-Based Intervention: Undergo HEAL"
94765|NCT02002533|O1|Outcome|Arm I (BBT Intervention)|"Patients undergo BBT intervention, comprising insomnia education, stimulus control, discouragement of napping and encouragement of exercise, and sleep compression over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Brief Behavioral Therapy: Undergo BBT intervention~Telephone-Based Intervention: Undergo BBT intervention"
94766|NCT02002533|O2|Outcome|Arm II (Control)|"Patients undergo HEAL comprising nutritional education and suggestions for symptom management over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Educational Intervention: Undergo HEAL~Telephone-Based Intervention: Undergo HEAL"
95146|NCT01999218|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104
94767|NCT02002533|O1|Outcome|Arm I (BBT Intervention)|"Patients undergo BBT intervention, comprising insomnia education, stimulus control, discouragement of napping and encouragement of exercise, and sleep compression over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Brief Behavioral Therapy: Undergo BBT intervention~Telephone-Based Intervention: Undergo BBT intervention"
94768|NCT02002533|O2|Outcome|Arm II (Control)|"Patients undergo HEAL comprising nutritional education and suggestions for symptom management over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Educational Intervention: Undergo HEAL~Telephone-Based Intervention: Undergo HEAL"
94769|NCT02002533|O1|Outcome|Arm I (BBT Intervention)|"Patients undergo BBT intervention, comprising insomnia education, stimulus control, discouragement of napping and encouragement of exercise, and sleep compression over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Brief Behavioral Therapy: Undergo BBT intervention~Telephone-Based Intervention: Undergo BBT intervention"
94770|NCT02002533|O2|Outcome|Arm II (Control)|"Patients undergo HEAL comprising nutritional education and suggestions for symptom management over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Educational Intervention: Undergo HEAL~Telephone-Based Intervention: Undergo HEAL"
94771|NCT02002533|O1|Outcome|Arm I (BBT Intervention)|"Patients undergo BBT intervention, comprising insomnia education, stimulus control, discouragement of napping and encouragement of exercise, and sleep compression over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Brief Behavioral Therapy: Undergo BBT intervention~Telephone-Based Intervention: Undergo BBT intervention"
94772|NCT02002533|O2|Outcome|Arm II (Control)|"Patients undergo HEAL comprising nutritional education and suggestions for symptom management over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Educational Intervention: Undergo HEAL~Telephone-Based Intervention: Undergo HEAL"
94773|NCT02002533|O1|Outcome|Arm I (BBT Intervention)|"Patients undergo BBT intervention, comprising insomnia education, stimulus control, discouragement of napping and encouragement of exercise, and sleep compression over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Brief Behavioral Therapy: Undergo BBT intervention~Telephone-Based Intervention: Undergo BBT intervention"
94774|NCT02002533|O2|Outcome|Arm II (Control)|"Patients undergo HEAL comprising nutritional education and suggestions for symptom management over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Educational Intervention: Undergo HEAL~Telephone-Based Intervention: Undergo HEAL"
94775|NCT02002533|O1|Outcome|Arm I (BBT Intervention)|"Patients undergo BBT intervention, comprising insomnia education, stimulus control, discouragement of napping and encouragement of exercise, and sleep compression over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Brief Behavioral Therapy: Undergo BBT intervention~Telephone-Based Intervention: Undergo BBT intervention"
94776|NCT02002533|O1|Outcome|All Participants|All people that were enrolled in the study regardless of intervention assigned.
94777|NCT02002533|E2|Reported Event|Arm II (Control)|"Patients undergo HEAL comprising nutritional education and suggestions for symptom management over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Educational Intervention: Undergo HEAL~Telephone-Based Intervention: Undergo HEAL"
94778|NCT02002533|E1|Reported Event|Arm I (BBT Intervention)|"Patients undergo BBT intervention, comprising insomnia education, stimulus control, discouragement of napping and encouragement of exercise, and sleep compression over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.~Brief Behavioral Therapy: Undergo BBT intervention~Telephone-Based Intervention: Undergo BBT intervention"
94779|NCT02002221|B3|Baseline|Total|Total of all reporting groups
94780|NCT02002221|B2|Baseline|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
94781|NCT02002221|B1|Baseline|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
94782|NCT02002221|P2|Participant Flow|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
94783|NCT02002221|P1|Participant Flow|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
94784|NCT02002221|O2|Outcome|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
94785|NCT02002221|O1|Outcome|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
94786|NCT02002221|O2|Outcome|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
94787|NCT02002221|O1|Outcome|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
94788|NCT02002221|O2|Outcome|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
94789|NCT02002221|O1|Outcome|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
94790|NCT02002221|O2|Outcome|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
94791|NCT02002221|O1|Outcome|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
94792|NCT02002221|O2|Outcome|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
94793|NCT02002221|O1|Outcome|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
94794|NCT02002221|E2|Reported Event|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
94795|NCT02002221|E1|Reported Event|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
94796|NCT02002208|B3|Baseline|Total|Total of all reporting groups
94797|NCT02002208|B2|Baseline|Placebo Tablets|"Orally once a day~OC000459: CRTH2 inhibitor"
94798|NCT02002208|B1|Baseline|OC000459 Tablets|"50 mg orally once a day~OC000459: CRTH2 inhibitor"
94799|NCT02002208|P2|Participant Flow|Placebo Tablets|"Orally once a day~OC000459: CRTH2 inhibitor"
94800|NCT02002208|P1|Participant Flow|OC000459 Tablets|"50 mg orally once a day~OC000459: CRTH2 inhibitor"
94801|NCT02002208|O2|Outcome|Placebo Tablets|Orally once a day
94802|NCT02002208|O1|Outcome|OC000459 Tablets|"50 mg orally once a day~OC000459: CRTH2 inhibitor"
94803|NCT02002208|O2|Outcome|Placebo Tablets|Orally once a day
94804|NCT02002208|O1|Outcome|OC000459 Tablets|"50 mg orally once a day~OC000459: CRTH2 inhibitor"
94805|NCT02002208|E2|Reported Event|Placebo Tablets|Orally once a day
94806|NCT02002208|E1|Reported Event|OC000459 Tablets|"50 mg orally once a day~OC000459: CRTH2 inhibitor"
94807|NCT02001714|B3|Baseline|Total|Total of all reporting groups
94808|NCT02001714|B2|Baseline|No Treatment|Subjects will not attend group behavioral treatment class but have the same follow-up visit schedule. Subjects will receive the same handout.
94809|NCT02001714|B1|Baseline|Group Behavioral Treatment|"Participants will attend a group behavioral treatment class and follow-up visits.~Group Behavioral Treatment: Group Behavioral Treatment class is a two hour class taught by certified interventionist covering urinary system anatomy, bladder health and self management strategies, pelvic floor training, pelvic floor muscle contracting techniques, and bladder training. Slides and handouts supplement the content of the class."
94810|NCT02001714|P2|Participant Flow|No Treatment|Subjects will not attend group behavioral treatment class but have the same follow-up visit schedule. Subjects will receive the same handout.
94811|NCT02001714|P1|Participant Flow|Group Behavioral Treatment|"Participants will attend a group behavioral treatment class and follow-up visits.~Group Behavioral Treatment: Group Behavioral Treatment class is a two hour class taught by certified interventionist covering urinary system anatomy, bladder health and self management strategies, pelvic floor training, pelvic floor muscle contracting techniques, and bladder training. Slides and handouts supplement the content of the class."
94812|NCT02001714|O2|Outcome|No Treatment|Subjects will not attend group behavioral treatment class but have the same follow-up visit schedule. Subjects will receive the same handout.
94813|NCT02001714|O1|Outcome|Group Behavioral Treatment|"Participants will attend a group behavioral treatment class and follow-up visits.~Group Behavioral Treatment: Group Behavioral Treatment class is a two hour class taught by certified interventionist covering urinary system anatomy, bladder health and self management strategies, pelvic floor training, pelvic floor muscle contracting techniques, and bladder training. Slides and handouts supplement the content of the class."
94814|NCT02001714|E2|Reported Event|No Treatment|Subjects will not attend group behavioral treatment class but have the same follow-up visit schedule. Subjects will receive the same handout.
94815|NCT02001714|E1|Reported Event|Group Behavioral Treatment|"Participants will attend a group behavioral treatment class and follow-up visits.~Group Behavioral Treatment: Group Behavioral Treatment class is a two hour class taught by certified interventionist covering urinary system anatomy, bladder health and self management strategies, pelvic floor training, pelvic floor muscle contracting techniques, and bladder training. Slides and handouts supplement the content of the class."
94816|NCT02001181|B3|Baseline|Total|Total of all reporting groups
94817|NCT02001181|B2|Baseline|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
94818|NCT02001181|B1|Baseline|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
94819|NCT02001181|P2|Participant Flow|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
94820|NCT02001181|P1|Participant Flow|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
94821|NCT02001181|O2|Outcome|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
94822|NCT02001181|O1|Outcome|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
94823|NCT02001181|O2|Outcome|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
94875|NCT02000973|O2|Outcome|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine 8ml
94824|NCT02001181|O1|Outcome|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
94825|NCT02001181|O2|Outcome|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
94826|NCT02001181|O1|Outcome|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
94827|NCT02001181|O2|Outcome|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
94828|NCT02001181|O1|Outcome|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
94829|NCT02001181|O2|Outcome|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
94830|NCT02001181|O1|Outcome|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
94831|NCT02001181|E2|Reported Event|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
94832|NCT02001181|E1|Reported Event|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
94833|NCT02001051|B3|Baseline|Total|Total of all reporting groups
94834|NCT02001051|B2|Baseline|Delayed Operative Arm Followed by Surgery|"delayed operative arm~Observation: Observation for 6 months prior to surgery"
94835|NCT02001051|B1|Baseline|Operative Arm|"operative arm~Adrenalectomy: Surgery to remove tumor when enrolled in the protocol."
94836|NCT02001051|P2|Participant Flow|Delayed Operative Arm Followed by Surgery|"delayed operative arm~Observation: Observation for 6 months prior to surgery"
94837|NCT02001051|P1|Participant Flow|Operative Arm|"operative arm~Adrenalectomy: Surgery to remove tumor when enrolled in the protocol."
94838|NCT02001051|O2|Outcome|Delayed Operative Arm|"delayed operative arm~Observation: Observation for 6 months prior to surgery"
94839|NCT02001051|O1|Outcome|Operative Arm|"operative arm~Adrenalectomy: Surgery to remove tumor when enrolled in the protocol."
94840|NCT02001051|O2|Outcome|Delayed Operative Arm|"delayed operative arm~Observation: Observation for 6 months prior to surgery"
94841|NCT02001051|O1|Outcome|Operative Arm|"operative arm~Adrenalectomy: Surgery to remove tumor when enrolled in the protocol."
94842|NCT02001051|O2|Outcome|Delayed Operative Arm|"delayed operative arm~Observation: Observation for 6 months prior to surgery"
94843|NCT02001051|O1|Outcome|Operative Arm|"operative arm~Adrenalectomy: Surgery to remove tumor when enrolled in the protocol."
94844|NCT02001051|O2|Outcome|Delayed Operative Arm|"delayed operative arm~Observation: Observation for 6 months prior to surgery"
94845|NCT02001051|O1|Outcome|Operative Arm|"operative arm~Adrenalectomy: Surgery to remove tumor when enrolled in the protocol."
94846|NCT02001051|O2|Outcome|Delayed Operative Arm|"delayed operative arm~Observation: Observation for 6 months prior to surgery"
94847|NCT02001051|O1|Outcome|Operative Arm|"operative arm~Adrenalectomy: Surgery to remove tumor when enrolled in the protocol."
94848|NCT02001051|O2|Outcome|Delayed Operative Arm|"delayed operative arm~Observation: Observation for 6 months prior to surgery"
94849|NCT02001051|O1|Outcome|Operative Arm|"operative arm~Adrenalectomy: Surgery to remove tumor when enrolled in the protocol."
94850|NCT02001051|O2|Outcome|Delayed Operative Arm|"delayed operative arm~Observation: Observation for 6 months prior to surgery"
94851|NCT02001051|O1|Outcome|Operative Arm|"operative arm~Adrenalectomy: Surgery to remove tumor when enrolled in the protocol."
94852|NCT02001051|O2|Outcome|Delayed Operative Arm|"delayed operative arm~Observation: Observation for 6 months prior to surgery"
94853|NCT02001051|O1|Outcome|Operative Arm|"operative arm~Adrenalectomy: Surgery to remove tumor when enrolled in the protocol."
94854|NCT02001051|E2|Reported Event|Delayed Operative Arm|"delayed operative arm~Observation: Observation for 6 months prior to surgery"
94855|NCT02001051|E1|Reported Event|Operative Arm|"operative arm~Adrenalectomy: Surgery to remove tumor when enrolled in the protocol."
94856|NCT02000973|B5|Baseline|Total|Total of all reporting groups
94857|NCT02000973|B4|Baseline|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine
94858|NCT02000973|B3|Baseline|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine
94859|NCT02000973|B2|Baseline|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine
94860|NCT02000973|B1|Baseline|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline
94861|NCT02000973|P4|Participant Flow|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine
94862|NCT02000973|P3|Participant Flow|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine
94863|NCT02000973|P2|Participant Flow|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine
94864|NCT02000973|P1|Participant Flow|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline
94865|NCT02000973|O4|Outcome|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
94866|NCT02000973|O3|Outcome|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
94867|NCT02000973|O2|Outcome|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine 8ml
94868|NCT02000973|O1|Outcome|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
94869|NCT02000973|O4|Outcome|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
94870|NCT02000973|O3|Outcome|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
94871|NCT02000973|O2|Outcome|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine 8ml
94872|NCT02000973|O1|Outcome|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
94873|NCT02000973|O4|Outcome|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
94874|NCT02000973|O3|Outcome|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
94922|NCT02000622|B3|Baseline|Total|Total of all reporting groups
94876|NCT02000973|O1|Outcome|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
94877|NCT02000973|O4|Outcome|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
94878|NCT02000973|O3|Outcome|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
94879|NCT02000973|O2|Outcome|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine 8ml
94880|NCT02000973|O1|Outcome|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
94881|NCT02000973|E4|Reported Event|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
94882|NCT02000973|E3|Reported Event|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
94883|NCT02000973|E2|Reported Event|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine 8ml
94884|NCT02000973|E1|Reported Event|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
94885|NCT02000921|B4|Baseline|Total|Total of all reporting groups
94886|NCT02000921|B3|Baseline|VLNC With Non-combusted Products|"Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.~VLNC cigarettes: Modified risk tobacco product~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
94887|NCT02000921|B2|Baseline|VLNC + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~VLNC cigarettes: Modified risk tobacco product~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
94888|NCT02000921|B1|Baseline|CN + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.~CN cigarettes: Experimental cigarettes with conventional nicotine content."
94889|NCT02000921|P3|Participant Flow|VLNC With Non-combusted Products|"Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.~VLNC cigarettes: Modified risk tobacco product~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
94890|NCT02000921|P2|Participant Flow|VLNC + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~VLNC cigarettes: Modified risk tobacco product~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
94891|NCT02000921|P1|Participant Flow|CN + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.~CN cigarettes: Experimental cigarettes with conventional nicotine content."
94892|NCT02000921|O3|Outcome|VLNC With Non-combusted Products|"Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.~VLNC cigarettes: Modified risk tobacco product~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
94893|NCT02000921|O2|Outcome|VLNC + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~VLNC cigarettes: Modified risk tobacco product~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
94894|NCT02000921|O1|Outcome|CN + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.~CN cigarettes: Experimental cigarettes with conventional nicotine content."
94895|NCT02000921|O3|Outcome|VLNC With Non-combusted Products|"Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.~VLNC cigarettes: Modified risk tobacco product~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
94923|NCT02000622|B2|Baseline|Chemotherapy|Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
94924|NCT02000622|B1|Baseline|Olaparib 300 mg bd|Olaparib 300 mg bd tablets
94925|NCT02000622|P2|Participant Flow|Chemotherapy|Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
94896|NCT02000921|O2|Outcome|VLNC + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~VLNC cigarettes: Modified risk tobacco product~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
94897|NCT02000921|O1|Outcome|CN + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.~CN cigarettes: Experimental cigarettes with conventional nicotine content."
94898|NCT02000921|O3|Outcome|VLNC With Non-combusted Products|"Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.~VLNC cigarettes: Modified risk tobacco product~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
94899|NCT02000921|O2|Outcome|VLNC + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~VLNC cigarettes: Modified risk tobacco product~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
94900|NCT02000921|O1|Outcome|CN + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.~CN cigarettes: Experimental cigarettes with conventional nicotine content."
94901|NCT02000921|O3|Outcome|VLNC With Non-combusted Products|"Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.~VLNC cigarettes: Modified risk tobacco product~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
94902|NCT02000921|O2|Outcome|VLNC + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~VLNC cigarettes: Modified risk tobacco product~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
94903|NCT02000921|O1|Outcome|CN + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.~CN cigarettes: Experimental cigarettes with conventional nicotine content."
94904|NCT02000921|E3|Reported Event|VLNC With Non-combusted Products|"Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.~VLNC cigarettes: Modified risk tobacco product~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
94905|NCT02000921|E2|Reported Event|VLNC + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~VLNC cigarettes: Modified risk tobacco product~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
94906|NCT02000921|E1|Reported Event|CN + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.~CN cigarettes: Experimental cigarettes with conventional nicotine content."
94907|NCT02000752|B3|Baseline|Total|Total of all reporting groups
94908|NCT02000752|B2|Baseline|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.~Sham acupuncture: Sham point acupuncture"
94926|NCT02000622|P1|Participant Flow|Olaparib 300 mg bd|Olaparib 300 mg bd tablets
94927|NCT02000622|O2|Outcome|Chemotherapy|Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
94909|NCT02000752|B1|Baseline|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.~Acupuncture"
94910|NCT02000752|P2|Participant Flow|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.~Acupuncture"
94911|NCT02000752|P1|Participant Flow|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.~Sham acupuncture: Sham point acupuncture"
94912|NCT02000752|O2|Outcome|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.~Acupuncture"
94913|NCT02000752|O1|Outcome|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.~Sham acupuncture: Sham point acupuncture"
94914|NCT02000752|O2|Outcome|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.~Acupuncture"
94915|NCT02000752|O1|Outcome|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.~Sham acupuncture: Sham point acupuncture"
94916|NCT02000752|O2|Outcome|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.~Acupuncture"
94917|NCT02000752|O1|Outcome|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.~Sham acupuncture: Sham point acupuncture"
94918|NCT02000752|O2|Outcome|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.~Acupuncture"
94919|NCT02000752|O1|Outcome|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.~Sham acupuncture: Sham point acupuncture"
94920|NCT02000752|E2|Reported Event|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.~Acupuncture"
94921|NCT02000752|E1|Reported Event|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.~Sham acupuncture: Sham point acupuncture"
94929|NCT02000622|O2|Outcome|Chemotherapy|Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
94930|NCT02000622|O1|Outcome|Olaparib 300 mg bd|Olaparib 300 mg bd tablets
94931|NCT02000622|O2|Outcome|Chemotherapy|Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
94932|NCT02000622|O1|Outcome|Olaparib 300 mg bd|Olaparib 300 mg bd tablets
94933|NCT02000622|O2|Outcome|Chemotherapy|Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
94934|NCT02000622|O1|Outcome|Olaparib 300 mg bd|Olaparib 300 mg bd tablets
94935|NCT02000622|O2|Outcome|Chemotherapy|Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
94936|NCT02000622|O1|Outcome|Olaparib 300 mg bd|Olaparib 300 mg bd tablets
94937|NCT02000622|O2|Outcome|Chemotherapy|Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
94938|NCT02000622|O1|Outcome|Olaparib 300 mg bd|Olaparib 300 mg bd tablets
94939|NCT02000622|O2|Outcome|Chemotherapy|Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
94940|NCT02000622|O1|Outcome|Olaparib 300 mg bd|Olaparib 300 mg bd tablets
94941|NCT02000622|O2|Outcome|Chemotherapy|Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
94942|NCT02000622|O1|Outcome|Olaparib 300 mg bd|Olaparib 300 mg bd tablets
94943|NCT02000622|E2|Reported Event|Chemotherapy|Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
94944|NCT02000622|E1|Reported Event|Olaparib 300 mg bd|Olaparib 300 mg bd tablets
94945|NCT02000531|B3|Baseline|Total|Total of all reporting groups
94946|NCT02000531|B2|Baseline|Chemotherapy-Erlotinib|Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
94947|NCT02000531|B1|Baseline|Erlotinib-Chemotherapy|Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
94948|NCT02000531|P2|Participant Flow|Chemotherapy-Erlotinib|Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
94949|NCT02000531|P1|Participant Flow|Erlotinib-Chemotherapy|Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
94950|NCT02000531|O2|Outcome|Chemotherapy-Erlotinib|Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
94951|NCT02000531|O1|Outcome|Erlotinib-Chemotherapy|Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
94952|NCT02000531|O2|Outcome|Chemotherapy-Erlotinib|Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
94953|NCT02000531|O1|Outcome|Erlotinib-Chemotherapy|Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
94954|NCT02000531|E2|Reported Event|Chemotherapy-Erlotinib|Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
94955|NCT02000531|E1|Reported Event|Erlotinib-Chemotherapy|Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
94956|NCT02000440|B1|Baseline|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
94957|NCT02000440|P1|Participant Flow|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
94958|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
94959|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
94960|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
94961|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
94962|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
94963|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
94964|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
94965|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
94966|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
94967|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
94968|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
94969|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
94970|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
94971|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
94972|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
94973|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
94974|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
94975|NCT02000440|E1|Reported Event|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
94976|NCT02000427|B1|Baseline|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
94977|NCT02000427|P1|Participant Flow|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
94978|NCT02000427|O1|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
94979|NCT02000427|O1|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
94980|NCT02000427|O1|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
94981|NCT02000427|O1|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
94982|NCT02000427|O1|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
94983|NCT02000427|O1|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
94984|NCT02000427|O1|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
94985|NCT02000427|O1|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
94986|NCT02000427|O1|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
94987|NCT02000427|O1|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
94988|NCT02000427|O1|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
94989|NCT02000427|O1|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
94990|NCT02000427|E1|Reported Event|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
94991|NCT02000180|B3|Baseline|Total|Total of all reporting groups
94992|NCT02000180|B2|Baseline|High-Fidelity Group|The high-fidelity group will undertake 6 hours of interactive small-group didactic and hands-on sessions on the theory of colonoscopy, led by an expert academic gastroenterologist. The sessions will be interlaced with up to six hours of self-directed instruction on the high-fidelity VR simulator. Six task-specific modules of increasing difficulty in colonoscopy and colonoscopic polypectomy will be taught solely on the VR simulator with one-on-one feedback from an expert academic endoscopist. The endoscopy instructor will demonstrate techniques, answer questions and provide feedback as necessary. The entirety of this will be delivered over two days.
94993|NCT02000180|B1|Baseline|Progressive Group|"The progressive learning group will undertake 6 hours of interactive small-group didactic sessions, interlaced with up to 6 hours of self-directed instruction initially on the low-fidelity box simulator, with feedback provided one-on-one by an expert academic endoscopist. Participants in the progressive learning group can switch to the high-fidelity simulator at their discretion, but cannot return to the low-fidelity simulator. On the high fidelity VR simulator they can progress through six modules each in colonoscopy and endoscopic polypectomy in a self-directed fashion, with one-on-one feedback by an expert academic endoscopist. The endoscopy instructor will demonstrate techniques, answer questions and provide feedback. The entirety of this will be delivered over two days.~Progressive Group"
94994|NCT02000180|P2|Participant Flow|High-Fidelity Group|The high-fidelity group will undertake 6 hours of interactive small-group didactic and hands-on sessions on the theory of colonoscopy, led by an expert academic gastroenterologist. The sessions will be interlaced with up to six hours of self-directed instruction on the high-fidelity VR simulator. Six task-specific modules of increasing difficulty in colonoscopy and colonoscopic polypectomy will be taught solely on the VR simulator with one-on-one feedback from an expert academic endoscopist. The endoscopy instructor will demonstrate techniques, answer questions and provide feedback as necessary. The entirety of this will be delivered over two days.
94995|NCT02000180|P1|Participant Flow|Progressive Group|"The progressive learning group will undertake 6 hours of interactive small-group didactic sessions, interlaced with up to 6 hours of self-directed instruction initially on the low-fidelity box simulator, with feedback provided one-on-one by an expert academic endoscopist. Participants in the progressive learning group can switch to the high-fidelity simulator at their discretion, but cannot return to the low-fidelity simulator. On the high fidelity VR simulator they can progress through six modules each in colonoscopy and endoscopic polypectomy in a self-directed fashion, with one-on-one feedback by an expert academic endoscopist. The endoscopy instructor will demonstrate techniques, answer questions and provide feedback. The entirety of this will be delivered over two days.~Progressive Group"
94996|NCT02000180|O2|Outcome|High-Fidelity Group|The high-fidelity group will undertake 6 hours of interactive small-group didactic and hands-on sessions on the theory of colonoscopy, led by an expert academic gastroenterologist. The sessions will be interlaced with up to six hours of self-directed instruction on the high-fidelity VR simulator. Six task-specific modules of increasing difficulty in colonoscopy and colonoscopic polypectomy will be taught solely on the VR simulator with one-on-one feedback from an expert academic endoscopist. The endoscopy instructor will demonstrate techniques, answer questions and provide feedback as necessary. The entirety of this will be delivered over two days.
94997|NCT02000180|O1|Outcome|Progressive Group|"The progressive learning group will undertake 6 hours of interactive small-group didactic sessions, interlaced with up to 6 hours of self-directed instruction initially on the low-fidelity box simulator, with feedback provided one-on-one by an expert academic endoscopist. Participants in the progressive learning group can switch to the high-fidelity simulator at their discretion, but cannot return to the low-fidelity simulator. On the high fidelity VR simulator they can progress through six modules each in colonoscopy and endoscopic polypectomy in a self-directed fashion, with one-on-one feedback by an expert academic endoscopist. The endoscopy instructor will demonstrate techniques, answer questions and provide feedback. The entirety of this will be delivered over two days.~Progressive Group"
94998|NCT02000180|O2|Outcome|High-Fidelity Group|The high-fidelity group will undertake 6 hours of interactive small-group didactic and hands-on sessions on the theory of colonoscopy, led by an expert academic gastroenterologist. The sessions will be interlaced with up to six hours of self-directed instruction on the high-fidelity VR simulator. Six task-specific modules of increasing difficulty in colonoscopy and colonoscopic polypectomy will be taught solely on the VR simulator with one-on-one feedback from an expert academic endoscopist. The endoscopy instructor will demonstrate techniques, answer questions and provide feedback as necessary. The entirety of this will be delivered over two days.
94999|NCT02000180|O1|Outcome|Progressive Group|"The progressive learning group will undertake 6 hours of interactive small-group didactic sessions, interlaced with up to 6 hours of self-directed instruction initially on the low-fidelity box simulator, with feedback provided one-on-one by an expert academic endoscopist. Participants in the progressive learning group can switch to the high-fidelity simulator at their discretion, but cannot return to the low-fidelity simulator. On the high fidelity VR simulator they can progress through six modules each in colonoscopy and endoscopic polypectomy in a self-directed fashion, with one-on-one feedback by an expert academic endoscopist. The endoscopy instructor will demonstrate techniques, answer questions and provide feedback. The entirety of this will be delivered over two days.~Progressive Group"
95000|NCT02000180|O2|Outcome|High-Fidelity Group|The high-fidelity group will undertake 6 hours of interactive small-group didactic and hands-on sessions on the theory of colonoscopy, led by an expert academic gastroenterologist. The sessions will be interlaced with up to six hours of self-directed instruction on the high-fidelity VR simulator. Six task-specific modules of increasing difficulty in colonoscopy and colonoscopic polypectomy will be taught solely on the VR simulator with one-on-one feedback from an expert academic endoscopist. The endoscopy instructor will demonstrate techniques, answer questions and provide feedback as necessary. The entirety of this will be delivered over two days.
95001|NCT02000180|O1|Outcome|Progressive Group|"The progressive learning group will undertake 6 hours of interactive small-group didactic sessions, interlaced with up to 6 hours of self-directed instruction initially on the low-fidelity box simulator, with feedback provided one-on-one by an expert academic endoscopist. Participants in the progressive learning group can switch to the high-fidelity simulator at their discretion, but cannot return to the low-fidelity simulator. On the high fidelity VR simulator they can progress through six modules each in colonoscopy and endoscopic polypectomy in a self-directed fashion, with one-on-one feedback by an expert academic endoscopist. The endoscopy instructor will demonstrate techniques, answer questions and provide feedback. The entirety of this will be delivered over two days.~Progressive Group"
95002|NCT02000180|O2|Outcome|High-Fidelity Group|The high-fidelity group will undertake 6 hours of interactive small-group didactic and hands-on sessions on the theory of colonoscopy, led by an expert academic gastroenterologist. The sessions will be interlaced with up to six hours of self-directed instruction on the high-fidelity VR simulator. Six task-specific modules of increasing difficulty in colonoscopy and colonoscopic polypectomy will be taught solely on the VR simulator with one-on-one feedback from an expert academic endoscopist. The endoscopy instructor will demonstrate techniques, answer questions and provide feedback as necessary. The entirety of this will be delivered over two days.
95003|NCT02000180|O1|Outcome|Progressive Group|"The progressive learning group will undertake 6 hours of interactive small-group didactic sessions, interlaced with up to 6 hours of self-directed instruction initially on the low-fidelity box simulator, with feedback provided one-on-one by an expert academic endoscopist. Participants in the progressive learning group can switch to the high-fidelity simulator at their discretion, but cannot return to the low-fidelity simulator. On the high fidelity VR simulator they can progress through six modules each in colonoscopy and endoscopic polypectomy in a self-directed fashion, with one-on-one feedback by an expert academic endoscopist. The endoscopy instructor will demonstrate techniques, answer questions and provide feedback. The entirety of this will be delivered over two days.~Progressive Group"
95004|NCT02000180|E2|Reported Event|High-Fidelity Group|The high-fidelity group will undertake 6 hours of interactive small-group didactic and hands-on sessions on the theory of colonoscopy, led by an expert academic gastroenterologist. The sessions will be interlaced with up to six hours of self-directed instruction on the high-fidelity VR simulator. Six task-specific modules of increasing difficulty in colonoscopy and colonoscopic polypectomy will be taught solely on the VR simulator with one-on-one feedback from an expert academic endoscopist. The endoscopy instructor will demonstrate techniques, answer questions and provide feedback as necessary. The entirety of this will be delivered over two days.
95005|NCT02000180|E1|Reported Event|Progressive Group|"The progressive learning group will undertake 6 hours of interactive small-group didactic sessions, interlaced with up to 6 hours of self-directed instruction initially on the low-fidelity box simulator, with feedback provided one-on-one by an expert academic endoscopist. Participants in the progressive learning group can switch to the high-fidelity simulator at their discretion, but cannot return to the low-fidelity simulator. On the high fidelity VR simulator they can progress through six modules each in colonoscopy and endoscopic polypectomy in a self-directed fashion, with one-on-one feedback by an expert academic endoscopist. The endoscopy instructor will demonstrate techniques, answer questions and provide feedback. The entirety of this will be delivered over two days.~Progressive Group"
95006|NCT02000154|B1|Baseline|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:~A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
95007|NCT02000154|P1|Participant Flow|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:~A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
95008|NCT02000154|O1|Outcome|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:~A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
95009|NCT02000154|O1|Outcome|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:~A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
95010|NCT02000154|O1|Outcome|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:~A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
95011|NCT02000154|O1|Outcome|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:~A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
95012|NCT02000154|O1|Outcome|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:~A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
95013|NCT02000154|E1|Reported Event|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:~A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
95014|NCT01999920|B3|Baseline|Total|Total of all reporting groups
95015|NCT01999920|B2|Baseline|Placebo|"Pill placebo.~Placebo: One to two pills per day for 12 weeks"
95131|NCT01999218|P1|Participant Flow|Ertugliflozin 5 mg|Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104
95132|NCT01999218|O3|Outcome|Glimepiride|Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104
95016|NCT01999920|B1|Baseline|Vilazodone|"Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.~Vilazodone: 10mg to 40mg per day for 12 weeks"
95017|NCT01999920|P2|Participant Flow|Placebo|"Pill placebo.~Placebo: One to two pills per day for 12 weeks"
95018|NCT01999920|P1|Participant Flow|Vilazodone|"Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.~Vilazodone: 10mg to 40mg per day for 12 weeks"
95019|NCT01999920|O2|Outcome|Placebo|"Pill placebo.~Placebo: One to two pills per day for 12 weeks"
95020|NCT01999920|O1|Outcome|Vilazodone|"Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.~Vilazodone: 10mg to 40mg per day for 12 weeks"
95021|NCT01999920|O2|Outcome|Placebo|"Pill placebo.~Placebo: One to two pills per day for 12 weeks"
95022|NCT01999920|O1|Outcome|Vilazodone|"Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.~Vilazodone: 10mg to 40mg per day for 12 weeks"
95023|NCT01999920|O2|Outcome|Placebo|"Pill placebo.~Placebo: One to two pills per day for 12 weeks"
95024|NCT01999920|O1|Outcome|Vilazodone|"Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.~Vilazodone: 10mg to 40mg per day for 12 weeks"
95025|NCT01999920|O2|Outcome|Placebo|"Pill placebo.~Placebo: One to two pills per day for 12 weeks"
95026|NCT01999920|O1|Outcome|Vilazodone|"Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.~Vilazodone: 10mg to 40mg per day for 12 weeks"
95027|NCT01999920|O2|Outcome|Placebo|"Pill placebo.~Placebo: One to two pills per day for 12 weeks"
95028|NCT01999920|O1|Outcome|Vilazodone|"Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.~Vilazodone: 10mg to 40mg per day for 12 weeks"
95029|NCT01999920|O2|Outcome|Placebo|"Pill placebo.~Placebo: One to two pills per day for 12 weeks"
95030|NCT01999920|O1|Outcome|Vilazodone|"Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.~Vilazodone: 10mg to 40mg per day for 12 weeks"
95031|NCT01999920|E2|Reported Event|Placebo|"Pill placebo.~Placebo: One to two pills per day for 12 weeks"
95032|NCT01999920|E1|Reported Event|Vilazodone|"Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.~Vilazodone: 10mg to 40mg per day for 12 weeks"
95033|NCT01999894|B1|Baseline|Memantine|Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
95034|NCT01999894|P1|Participant Flow|Memantine|Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
95035|NCT01999894|O1|Outcome|Memantine|Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
95036|NCT01999894|E2|Reported Event|Memantine to Memantine|Patients who received Memantine during the double-blind lead-in study continued to receive Memantine during a 6-week lead-in, followed by 42 weeks of Open Label Memantine - Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
95037|NCT01999894|E1|Reported Event|Placebo to Memantine|Patients who received placebo during the double-blind lead-in study, were titrated to Memantine during a 6-week lead-in to 42 weeks of Open Label Memantine - Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
95038|NCT01999400|B1|Baseline|All Study Participants|"Participants who were randomized to one of the six arms of this study:~Arm 1: Pentasa then Delzicol then Apriso then Lialda Arm 2: Pentasa then Delzicol then Lialda then Apriso Arm 3: Apriso then Delzicol then Pentasa then Lialda Arm 4: Apriso then Delzicol then Lialda then Pentasa Arm 5: Lialda then Delzicol then Pentasa then Apriso Arm 6: Lialda then Delzicol then Apriso then Pentasa"
95039|NCT01999400|P6|Participant Flow|Arm 6: Lialda Then Delzicol Then Apriso Then Pentasa|"Lialda 1200 mg tablet x 1 with 240 mL water, single dose.~Washout period of 10 days.~Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.~Washout period of 10 days.~Apriso 375 mg capsule x 3 with 240 mL water, single dose.~Washout period of 10 days.~Pentasa 500 mg capsule x 2 with 240 mL water, single dose."
95040|NCT01999400|P5|Participant Flow|Arm 5: Lialda Then Delzicol Then Pentasa Then Apriso|"Lialda 1200 mg tablet x 1 with 240 mL water, single dose.~Washout period of 10 days.~Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.~Washout period of 10 days.~Pentasa 500 mg capsule x 2 with 240 mL water, single dose.~Washout period of 10 days.~Apriso 375 mg capsule x 3 with 240 mL water, single dose."
95133|NCT01999218|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin 15 mg QD from Day 1 to Week 104
95134|NCT01999218|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104
95135|NCT01999218|O3|Outcome|Glimepiride|Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104
95041|NCT01999400|P4|Participant Flow|Arm 4: Apriso Then Delzicol Then Lialda Then Pentasa|"Apriso 375 mg capsule x 3 with 240 mL water, single dose.~Washout period of 10 days.~Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.~Washout period of 10 days.~Lialda 1200 mg tablet x 1 with 240 mL water, single dose.~Washout period of 10 days.~Pentasa 500 mg capsule x 2 with 240 mL water, single dose."
95042|NCT01999400|P3|Participant Flow|Arm 3: Apriso Then Delzicol Then Pentasa Then Lialda|"Apriso 375 mg capsule x 3 with 240 mL water, single dose.~Washout period of 10 days.~Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.~Washout period of 10 days.~Pentasa 500 mg capsule x 2 with 240 mL water, single dose.~Washout period of 10 days.~Lialda 1200 mg tablet x 1 with 240 mL water, single dose."
95043|NCT01999400|P2|Participant Flow|Arm 2: Pentasa Then Delzicol Then Lialda Then Apriso|"Pentasa 500 mg capsule x 2 with 240 mL water, single dose.~Washout period of 10 days.~Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.~Washout period of 10 days.~Lialda 1200 mg tablet x 1 with 240 mL water, single dose.~Washout period of 10 days.~Apriso 375 mg capsule x 3 with 240 mL water, single dose."
95044|NCT01999400|P1|Participant Flow|Arm 1: Pentasa Then Delzicol Then Apriso Then Lialda|"Pentasa 500 mg capsule x 2 with 240 mL water, single dose.~Washout period of 10 days.~Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.~Washout period of 10 days.~Apriso 375 mg capsule x 3 with 240 mL water, single dose.~Washout period of 10 days.~Lialda 1200 mg tablet x 1 with 240 mL water, single dose."
95045|NCT01999400|O3|Outcome|Lialda|"Lialda 1200 mg tablet x 1 with 240 mL water, single dose~Lialda 1200 mg tablet x 1 with 240 mL water; single dose"
95046|NCT01999400|O2|Outcome|Apriso|"Apriso 375 mg capsule x 3 with 240 mL water, single dose~Apriso 375 mg capsule x 3 with 240 mL water; single dose"
95047|NCT01999400|O1|Outcome|Pentasa|"Pentasa 500 mg capsule x 2 with 240 mL water, single dose~Pentasa 500 mg capsule x 2 with 240 mL water; single dose"
95048|NCT01999400|O3|Outcome|Lialda|"Lialda 1200 mg tablet x 1 with 240 mL water, single dose~Lialda 1200 mg tablet x 1 with 240 mL water; single dose"
95049|NCT01999400|O2|Outcome|Apriso|"Apriso 375 mg capsule x 3 with 240 mL water, single dose~Apriso 375 mg capsule x 3 with 240 mL water; single dose"
95050|NCT01999400|O1|Outcome|Pentasa|"Pentasa 500 mg capsule x 2 with 240 mL water, single dose~Pentasa 500 mg capsule x 2 with 240 mL water; single dose"
95051|NCT01999400|O4|Outcome|Delzicol|"Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose~Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose"
95052|NCT01999400|O3|Outcome|Lialda|"Lialda 1200 mg tablet x 1 with 240 mL water, single dose~Lialda 1200 mg tablet x 1 with 240 mL water; single dose"
95053|NCT01999400|O2|Outcome|Apriso|"Apriso 375 mg capsule x 3 with 240 mL water, single dose~Apriso 375 mg capsule x 3 with 240 mL water; single dose"
95054|NCT01999400|O1|Outcome|Pentasa|"Pentasa 500 mg capsule x 2 with 240 mL water, single dose~Pentasa 500 mg capsule x 2 with 240 mL water; single dose"
95055|NCT01999400|O4|Outcome|Delzicol|"Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose~Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose"
95056|NCT01999400|O3|Outcome|Lialda|"Lialda 1200 mg tablet x 1 with 240 mL water, single dose~Lialda 1200 mg tablet x 1 with 240 mL water; single dose"
95057|NCT01999400|O2|Outcome|Apriso|"Apriso 375 mg capsule x 3 with 240 mL water, single dose~Apriso 375 mg capsule x 3 with 240 mL water; single dose"
95058|NCT01999400|O1|Outcome|Pentasa|"Pentasa 500 mg capsule x 2 with 240 mL water, single dose~Pentasa 500 mg capsule x 2 with 240 mL water; single dose"
95059|NCT01999400|E4|Reported Event|Delzicol|"Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose~Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose"
95060|NCT01999400|E3|Reported Event|Lialda|"Lialda 1200 mg tablet x 1 with 240 mL water, single dose~Lialda 1200 mg tablet x 1 with 240 mL water; single dose"
95061|NCT01999400|E2|Reported Event|Apriso|"Apriso 375 mg capsule x 3 with 240 mL water, single dose~Apriso 375 mg capsule x 3 with 240 mL water; single dose"
95062|NCT01999400|E1|Reported Event|Pentasa|"Pentasa 500 mg capsule x 2 with 240 mL water, single dose~Pentasa 500 mg capsule x 2 with 240 mL water; single dose"
95063|NCT01999348|B1|Baseline|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
95064|NCT01999348|P1|Participant Flow|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
95065|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
95066|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
95067|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
95068|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
95069|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
95070|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
95071|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
95072|NCT01999348|E1|Reported Event|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
95073|NCT01999322|B3|Baseline|Total|Total of all reporting groups
95136|NCT01999218|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin 15 mg QD from Day 1 to Week 104
95137|NCT01999218|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104
95074|NCT01999322|B2|Baseline|NovoRapid®|Subjects received NovoRapid® for a duration of 6 weeks. NovoRapid® was provided in 100U/ml 3 ml Penfill® and administered in accordance with the instructions provided by the pump manufacturer, preferably in the abdomen, by subcutaneous infusion. The insulin dose adjustments were made based on frequent glucose measurements during contacts with the investigator. The following glycaemic targets were recommended: preprandial and bedtime glucose: below 6.0 mmol/L (108 mg/dL) and 2 hr postprandial glucose: below 7.8 mmol/L (140 mg/dL).
95075|NCT01999322|B1|Baseline|Faster-acting Insulin Aspart|Subjects received faster-acting insulin aspart for a duration of 6 weeks. Faster-acting insulin aspart was provided in 100U/ml 3 mL Penfill® and administered in accordance with the instructions provided by the pump manufacturer, preferably in the abdomen, by subcutaneous infusion. The insulin dose adjustments were made based on frequent glucose measurements during contacts with the investigator. The following glycaemic targets were recommended: preprandial and bedtime glucose: below 6.0 mmol/L (108 mg/dL) and 2-hr postprandial glucose: below 7.8 mmol/L (140 mg/dL). A 2:1 randomisation following the screening period was selected in order to ensure adequate exposure to faster-acting insulin aspart.
95076|NCT01999322|P2|Participant Flow|NovoRapid®|Subjects received NovoRapid® for a duration of 6 weeks. NovoRapid® was provided in 100U/ml 3 ml Penfill® and administered in accordance with the instructions provided by the pump manufacturer, preferably in the abdomen, by subcutaneous infusion. The insulin dose adjustments were made based on frequent glucose measurements during contacts with the investigator. The following glycaemic targets were recommended: preprandial and bedtime glucose: below 6.0 mmol/L (108 mg/dL) and 2 hr postprandial glucose: below 7.8 mmol/L (140 mg/dL).
95077|NCT01999322|P1|Participant Flow|Faster-acting Insulin Aspart|Subjects received faster-acting insulin aspart for a duration of 6 weeks. Faster-acting insulin aspart was provided in 100U/ml 3 mL Penfill® and administered in accordance with the instructions provided by the pump manufacturer, preferably in the abdomen, by subcutaneous infusion. The insulin dose adjustments were made based on frequent glucose measurements during contacts with the investigator. The following glycaemic targets were recommended: preprandial and bedtime glucose: below 6.0 mmol/L (108 mg/dL) and 2-hr postprandial glucose: below 7.8 mmol/L (140 mg/dL). A 2:1 randomisation following the screening period was selected in order to ensure adequate exposure to faster-acting insulin aspart.
95078|NCT01999322|O2|Outcome|NovoRapid®|Subjects received NovoRapid® for a duration of 6 weeks. NovoRapid® was provided in 100U/ml 3 ml Penfill® and administered in accordance with the instructions provided by the pump manufacturer, preferably in the abdomen, by subcutaneous infusion. The insulin dose adjustments were made based on frequent glucose measurements during contacts with the investigator. The following glycaemic targets were recommended: preprandial and bedtime glucose: below 6.0 mmol/L (108 mg/dL) and 2 hr postprandial glucose: below 7.8 mmol/L (140 mg/dL).
95079|NCT01999322|O1|Outcome|Faster-acting Insulin Aspart|Subjects received faster-acting insulin aspart for a duration of 6 weeks. Faster-acting insulin aspart was provided in 100U/ml 3 mL Penfill® and administered in accordance with the instructions provided by the pump manufacturer, preferably in the abdomen, by subcutaneous infusion. The insulin dose adjustments were made based on frequent glucose measurements during contacts with the investigator. The following glycaemic targets were recommended: preprandial and bedtime glucose: below 6.0 mmol/L (108 mg/dL) and 2-hr postprandial glucose: below 7.8 mmol/L (140 mg/dL). A 2:1 randomisation following the screening period was selected in order to ensure adequate exposure to faster-acting insulin aspart.
95080|NCT01999322|O2|Outcome|NovoRapid®|Subjects received NovoRapid® for a duration of 6 weeks. NovoRapid® was provided in 100U/ml 3 ml Penfill® and administered in accordance with the instructions provided by the pump manufacturer, preferably in the abdomen, by subcutaneous infusion. The insulin dose adjustments were made based on frequent glucose measurements during contacts with the investigator. The following glycaemic targets were recommended: preprandial and bedtime glucose: below 6.0 mmol/L (108 mg/dL) and 2 hr postprandial glucose: below 7.8 mmol/L (140 mg/dL).
95081|NCT01999322|O1|Outcome|Faster-acting Insulin Aspart|Subjects received faster-acting insulin aspart for a duration of 6 weeks. Faster-acting insulin aspart was provided in 100U/ml 3 mL Penfill® and administered in accordance with the instructions provided by the pump manufacturer, preferably in the abdomen, by subcutaneous infusion. The insulin dose adjustments were made based on frequent glucose measurements during contacts with the investigator. The following glycaemic targets were recommended: preprandial and bedtime glucose: below 6.0 mmol/L (108 mg/dL) and 2-hr postprandial glucose: below 7.8 mmol/L (140 mg/dL). A 2:1 randomisation following the screening period was selected in order to ensure adequate exposure to faster-acting insulin aspart.
95082|NCT01999322|O2|Outcome|NovoRapid®|Subjects received NovoRapid® for a duration of 6 weeks. NovoRapid® was provided in 100U/ml 3 ml Penfill® and administered in accordance with the instructions provided by the pump manufacturer, preferably in the abdomen, by subcutaneous infusion. The insulin dose adjustments were made based on frequent glucose measurements during contacts with the investigator. The following glycaemic targets were recommended: preprandial and bedtime glucose: below 6.0 mmol/L (108 mg/dL) and 2 hr postprandial glucose: below 7.8 mmol/L (140 mg/dL).
95083|NCT01999322|O1|Outcome|Faster-acting Insulin Aspart|Subjects received faster-acting insulin aspart for a duration of 6 weeks. Faster-acting insulin aspart was provided in 100U/ml 3 mL Penfill® and administered in accordance with the instructions provided by the pump manufacturer, preferably in the abdomen, by subcutaneous infusion. The insulin dose adjustments were made based on frequent glucose measurements during contacts with the investigator. The following glycaemic targets were recommended: preprandial and bedtime glucose: below 6.0 mmol/L (108 mg/dL) and 2-hr postprandial glucose: below 7.8 mmol/L (140 mg/dL). A 2:1 randomisation following the screening period was selected in order to ensure adequate exposure to faster-acting insulin aspart.
95084|NCT01999322|O2|Outcome|NovoRapid®|Subjects received NovoRapid® for a duration of 6 weeks. NovoRapid® was provided in 100U/ml 3 ml Penfill® and administered in accordance with the instructions provided by the pump manufacturer, preferably in the abdomen, by subcutaneous infusion. The insulin dose adjustments were made based on frequent glucose measurements during contacts with the investigator. The following glycaemic targets were recommended: preprandial and bedtime glucose: below 6.0 mmol/L (108 mg/dL) and 2 hr postprandial glucose: below 7.8 mmol/L (140 mg/dL).
95138|NCT01999218|O3|Outcome|Glimepiride|Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104
95139|NCT01999218|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin 15 mg QD from Day 1 to Week 104
95140|NCT01999218|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104
95085|NCT01999322|O1|Outcome|Faster-acting Insulin Aspart|Subjects received faster-acting insulin aspart for a duration of 6 weeks. Faster-acting insulin aspart was provided in 100U/ml 3 mL Penfill® and administered in accordance with the instructions provided by the pump manufacturer, preferably in the abdomen, by subcutaneous infusion. The insulin dose adjustments were made based on frequent glucose measurements during contacts with the investigator. The following glycaemic targets were recommended: preprandial and bedtime glucose: below 6.0 mmol/L (108 mg/dL) and 2-hr postprandial glucose: below 7.8 mmol/L (140 mg/dL). A 2:1 randomisation following the screening period was selected in order to ensure adequate exposure to faster-acting insulin aspart.
95086|NCT01999322|E2|Reported Event|NovoRapid®|Subjects received NovoRapid® for a duration of 6 weeks. NovoRapid® was provided in 100U/ml 3 ml Penfill® and administered in accordance with the instructions provided by the pump manufacturer, preferably in the abdomen, by subcutaneous infusion. The insulin dose adjustments were made based on frequent glucose measurements during contacts with the investigator. The following glycaemic targets were recommended: preprandial and bedtime glucose: below 6.0 mmol/L (108 mg/dL) and 2 hr postprandial glucose: below 7.8 mmol/L (140 mg/dL).
95087|NCT01999322|E1|Reported Event|Faster-acting Insulin Aspart|Subjects received faster-acting insulin aspart for a duration of 6 weeks. Faster-acting insulin aspart was provided in 100U/ml 3 mL Penfill® and administered in accordance with the instructions provided by the pump manufacturer, preferably in the abdomen, by subcutaneous infusion. The insulin dose adjustments were made based on frequent glucose measurements during contacts with the investigator. The following glycaemic targets were recommended: preprandial and bedtime glucose: below 6.0 mmol/L (108 mg/dL) and 2-hr postprandial glucose: below 7.8 mmol/L (140 mg/dL). A 2:1 randomisation following the screening period was selected in order to ensure adequate exposure to faster-acting insulin aspart.
95088|NCT01999231|B5|Baseline|Total|Total of all reporting groups
95089|NCT01999231|B4|Baseline|20μg/ml ESAT6-CFP10|24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) .
95090|NCT01999231|B3|Baseline|10μg/ml ESAT6-CFP10|24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) .
95091|NCT01999231|B2|Baseline|5μg/ml ESAT6-CFP10|24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) .
95092|NCT01999231|B1|Baseline|1μg/ml ESAT6-CFP10|24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) .
95093|NCT01999231|P4|Participant Flow|20μg/ml ESAT6-CFP10|"We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) .~Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes ."
95094|NCT01999231|P3|Participant Flow|10μg/ml ESAT6-CFP10|"We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) .~Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes .~Make sure 10μg/ml ESAT6-CFP10 group finally finished injection and observed seven days with no serious adverse reaction, then carry out 20μg/ml ESAT6-CFP10 groups ."
95095|NCT01999231|P2|Participant Flow|5μg/ml ESAT6-CFP10|"We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) .~Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes .~Make sure 5μg/ml ESAT6-CFP10 group finally finished injection and observed seven days with no serious adverse reaction, then carry out 10μg/ml ESAT6-CFP10 groups ."
95141|NCT01999218|O3|Outcome|Glimepiride|Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104
95142|NCT01999218|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin 15 mg QD from Day 1 to Week 104
95143|NCT01999218|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104
95144|NCT01999218|O3|Outcome|Glimepiride|Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104
95145|NCT01999218|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin 15 mg QD from Day 1 to Week 104
95096|NCT01999231|P1|Participant Flow|1μg/ml ESAT6-CFP10|"We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) .~Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes .~Make sure 1μg/ml ESAT6-CFP10 group finally finished injection and observed seven days with no serious adverse reaction, then carry out 5μg/ml ESAT6-CFP10 groups ."
95097|NCT01999231|O4|Outcome|20μg/ml ESAT6-CFP10|Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
95098|NCT01999231|O3|Outcome|10μg/ml ESAT6-CFP10|Concentration of 10 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
95099|NCT01999231|O2|Outcome|5μg/ml ESAT6-CFP10|Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
95100|NCT01999231|O1|Outcome|1μg/ml ESAT6-CFP10|Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
95101|NCT01999231|O4|Outcome|20μg/ml ESAT6-CFP10|Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
95102|NCT01999231|O3|Outcome|10μg/ml ESAT6-CFP10|Concentration of 10 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
95103|NCT01999231|O2|Outcome|5μg/ml ESAT6-CFP10|Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
95104|NCT01999231|O1|Outcome|1μg/ml ESAT6-CFP10|Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
95105|NCT01999231|O4|Outcome|20μg/ml ESAT6-CFP10|Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
95106|NCT01999231|O3|Outcome|10μg/ml ESAT6-CFP10|Concentration of 10 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
95107|NCT01999231|O2|Outcome|5μg/ml ESAT6-CFP10|Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
95108|NCT01999231|O1|Outcome|1μg/ml ESAT6-CFP10|Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
95109|NCT01999231|O4|Outcome|20μg/ml ESAT6-CFP10|Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; A single dose
95110|NCT01999231|O3|Outcome|10μg/ml ESAT6-CFP10|Concentration of 10ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
95111|NCT01999231|O2|Outcome|5μg/ml ESAT6-CFP10|Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
95112|NCT01999231|O1|Outcome|1μg/ml ESAT6-CFP10|Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
95113|NCT01999231|O4|Outcome|20μg/ml ESAT6-CFP10|Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
95114|NCT01999231|O3|Outcome|10μg/ml ESAT6-CFP10|Concentration of 10 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
95115|NCT01999231|O2|Outcome|5μg/ml ESAT6-CFP10|Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
95116|NCT01999231|O1|Outcome|1μg/ml ESAT6-CFP10|Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
95117|NCT01999231|O4|Outcome|20μg/ml ESAT6-CFP10|Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; A single dose
95118|NCT01999231|O3|Outcome|10μg/ml ESAT6-CFP10|Concentration of 10ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
95119|NCT01999231|O2|Outcome|5μg/ml ESAT6-CFP10|Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
95120|NCT01999231|O1|Outcome|1μg/ml ESAT6-CFP10|Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
95121|NCT01999231|E4|Reported Event|20μg/ml ESAT6-CFP10|There is no adverse event.
95122|NCT01999231|E3|Reported Event|10μg/ml ESAT6-CFP10|There is no adverse event.
95123|NCT01999231|E2|Reported Event|5μg/ml ESAT6-CFP10|"Medicine Number 2 participant 15 min and 30 min after skin test is observed local skin reactions and all found that scattered red dot (32 x 25 mm )appeared .After 30min each time point local skin reactions were negative .~This mild local skin reactions may be relevant with alcohol allergy , had nothing to do with experimental drugs by the judgement of principal investigator ."
95124|NCT01999231|E1|Reported Event|1μg/ml ESAT6-CFP10|"Medicine Number 6 participant 24 h after test skin test, is observed local skin reactions and found subcutaneous hemorrhage ( 2 x 2 mm),48 h the subcutaneous hemorrhage is remain and becomes shallow ,72 h the subcutaneous hemorrhage is the same size and becomes lower shallow ,96 h the skin reaction has faded .This mild local skin reactions may be relevant with acupuncture of skin test , had nothing to do with experimental drugs by the judgement of principal investigator .~Medicine Number 12 participant occurred two cases of adverse events the seventh days after skin test :respectively pregnancy and a small amount of pleural effusion on both sides .This volunteer test results of a pregnancy test paper were negative in screening period,pregnancy test result were positive the seventh days after the skin test."
95125|NCT01999218|B4|Baseline|Total|Total of all reporting groups
95126|NCT01999218|B3|Baseline|Glimepiride|Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104
95127|NCT01999218|B2|Baseline|Ertugliflozin 15 mg|Ertugliflozin 15 mg QD from Day 1 to Week 104
95128|NCT01999218|B1|Baseline|Ertugliflozin 5 mg|Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104
95129|NCT01999218|P3|Participant Flow|Glimepiride|Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104
95147|NCT01999218|O3|Outcome|Glimepiride|Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104
95148|NCT01999218|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin 15 mg QD from Day 1 to Week 104
95149|NCT01999218|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104
95150|NCT01999218|E3|Reported Event|Glimepiride|Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104
95151|NCT01999218|E2|Reported Event|Ertugliflozin 15 mg|Ertugliflozin 15 mg QD from Day 1 to Week 104
95152|NCT01999218|E1|Reported Event|Ertugliflozin 5 mg|Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104
95153|NCT01999192|B5|Baseline|Total|Total of all reporting groups
95154|NCT01999192|B4|Baseline|Placebo|Placebo s.c. weekly
95155|NCT01999192|B3|Baseline|Dose Level 3 Tregalizumab|200mg Tregalizumab s.c. weekly
95156|NCT01999192|B2|Baseline|Dose Level 2 Tregalizumab|100mg Tregalizumab s.c. weekly
95157|NCT01999192|B1|Baseline|Dose Level 1 Tregalizumab|25mg Tregalizumab s.c. weekly
95158|NCT01999192|P4|Participant Flow|Placebo|Placebo s.c. weekly
95159|NCT01999192|P3|Participant Flow|Dose Level 3 Tregalizumab|200mg Tregalizumab s.c. weekly
95160|NCT01999192|P2|Participant Flow|Dose Level 2 Tregalizumab|100mg Tregalizumab s.c. weekly
95161|NCT01999192|P1|Participant Flow|Dose Level 1 Tregalizumab|25mg Tregalizumab s.c. weekly
95162|NCT01999192|O4|Outcome|Placebo|Placebo s.c. weekly
95163|NCT01999192|O3|Outcome|Dose Level 3 Tregalizumab|200mg Tregalizumab s.c. weekly
95164|NCT01999192|O2|Outcome|Dose Level 2 Tregalizumab|100mg Tregalizumab s.c. weekly
95165|NCT01999192|O1|Outcome|Dose Level 1 Tregalizumab|25mg Tregalizumab s.c. weekly
95166|NCT01999192|E4|Reported Event|Placebo|Placebo -
95167|NCT01999192|E3|Reported Event|200mg Dose Level 3 Tregalizumab|Dose Level 3 Tregalizumab (200mg)
95168|NCT01999192|E2|Reported Event|100mg Dose Level 2 Tregalizumab|Dose Level 2 Tregalizumab (100mg)
95169|NCT01999192|E1|Reported Event|25mg Dose Level 1 Tregalizumab|Dose Level 1 Tregalizumab (25mg)
95170|NCT01998919|B3|Baseline|Total|Total of all reporting groups
95171|NCT01998919|B2|Baseline|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
95172|NCT01998919|B1|Baseline|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via intravenous (IV) infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
95173|NCT01998919|P2|Participant Flow|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
95174|NCT01998919|P1|Participant Flow|Placebo Plus Chemotherapy|Participants received placebo tablets, orally (PO), on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 milligrams per square meter (mg/m^2) via intravenous (IV) infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 times [x] area under the serum concentration-time curve [AUC]), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
95175|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
95176|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
95177|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
95178|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
95277|NCT01998737|O1|Outcome|Women Under Osteoporosis Suspicion|As defined in the protocol
95278|NCT01998737|O2|Outcome|Healthy Women|As defined in the protocol
95179|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
95180|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
95181|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
95182|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
95183|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
95184|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
95185|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
95186|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
95187|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
95188|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
95189|NCT01998919|E2|Reported Event|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
95190|NCT01998919|E1|Reported Event|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
95191|NCT01998906|B4|Baseline|Total|Total of all reporting groups
95192|NCT01998906|B3|Baseline|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95193|NCT01998906|B2|Baseline|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95194|NCT01998906|B1|Baseline|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
95195|NCT01998906|P3|Participant Flow|HER2- Doxorubicin/Paclitaxel/CMF (HER2-C)|"Participants with human epidermal growth factor receptor proto-oncogene negative (HER2-) breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95196|NCT01998906|P2|Participant Flow|HER2+ Doxorubicin/Paclitaxel/CMF (HER2+C)|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95197|NCT01998906|P1|Participant Flow|HER2+ Trastuzumab/Doxorubicin/Paclitaxel/CMF (HER2+TC)|"Participants with human epidermal growth factor receptor 2 proto-oncogene positive (HER2+) breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 milligrams per kilogram (mg/kg), intravenously (IV) on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/square meter (mg/m^2), IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
95198|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95199|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95200|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
95201|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95202|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95203|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Day 1, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Days 1 and 8, followed by 1 week off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
95204|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95205|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95206|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
95207|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95208|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95209|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
95210|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95211|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95212|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
95213|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95214|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95215|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
95216|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95243|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
95279|NCT01998737|O1|Outcome|Women Under Osteoporosis Suspicion|As defined in the protocol
95217|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95218|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
95219|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received doxorubicin, paclitaxel, and CMF as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Day 1, followed by 2 weeks off."
95220|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received doxorubicin, paclitaxel and CMF as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Day 1, followed by 2 weeks off."
95221|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
95222|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95223|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95224|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
95225|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95226|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95227|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
95228|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95244|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
95280|NCT01998737|E2|Reported Event|Healthy Women|
95229|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95230|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
95231|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95232|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95233|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
95234|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95235|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95236|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
95237|NCT01998906|E3|Reported Event|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95238|NCT01998906|E2|Reported Event|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
95239|NCT01998906|E1|Reported Event|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Day 1, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Days 1 and 8, followed by 1 week off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
95240|NCT01998893|B1|Baseline|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
95241|NCT01998893|P1|Participant Flow|Rituximab|Participants received rituximab, 375 milligrams per square meter (mg/m^2), intravenously (IV), over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
95242|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
95245|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
95246|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
95247|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
95248|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
95249|NCT01998893|E1|Reported Event|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
95250|NCT01998880|B3|Baseline|Total|Total of all reporting groups
95251|NCT01998880|B2|Baseline|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
95252|NCT01998880|B1|Baseline|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
95253|NCT01998880|P2|Participant Flow|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
95254|NCT01998880|P1|Participant Flow|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
95255|NCT01998880|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
95256|NCT01998880|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
95257|NCT01998880|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
95258|NCT01998880|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
95259|NCT01998880|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
95260|NCT01998880|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
95261|NCT01998880|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
95262|NCT01998880|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
95263|NCT01998880|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
95264|NCT01998880|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
95265|NCT01998880|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
95266|NCT01998880|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
95267|NCT01998880|E2|Reported Event|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
95268|NCT01998880|E1|Reported Event|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
95269|NCT01998737|B3|Baseline|Total|Total of all reporting groups
95270|NCT01998737|B2|Baseline|Healthy Women|
95271|NCT01998737|B1|Baseline|Women Under Osteoporosis Suspicion|
95272|NCT01998737|P2|Participant Flow|Healthy Women|In healthy group females without risk factors for fracture or diseases affecting bone health were recruited.
95273|NCT01998737|P1|Participant Flow|Women Under Osteoporosis Suspicion|Subjects with at least one risk factor for osteoporotic fracture.
95274|NCT01998737|O2|Outcome|Healthy Women|As defined in the protocol
95275|NCT01998737|O1|Outcome|Women Under Osteoporosis Suspicion|As defined in the protocol
95276|NCT01998737|O2|Outcome|Healthy Women|As defined in the protocol
95283|NCT01998581|B2|Baseline|Restylane-L®|Lips injected with Restylane-L®
95284|NCT01998581|B1|Baseline|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
95285|NCT01998581|P2|Participant Flow|Restylane-L®|Lips injected with Restylane-L®
95286|NCT01998581|P1|Participant Flow|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
95287|NCT01998581|O2|Outcome|Restylane-L®|Lips injected with Restylane-L®
95288|NCT01998581|O1|Outcome|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
95289|NCT01998581|O2|Outcome|Restylane-L®|Lips injected with Restylane-L®
95290|NCT01998581|O1|Outcome|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
95291|NCT01998581|O2|Outcome|Restylane-L®|Lips injected with Restylane-L®
95292|NCT01998581|O1|Outcome|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
95293|NCT01998581|E2|Reported Event|Restylane-L®|Lips injected with Restylane-L®
95294|NCT01998581|E1|Reported Event|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
95295|NCT01998477|B3|Baseline|Total|Total of all reporting groups
95296|NCT01998477|B2|Baseline|TIV (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
95297|NCT01998477|B1|Baseline|TIVc (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
95298|NCT01998477|P2|Participant Flow|TIV (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
95299|NCT01998477|P1|Participant Flow|TIVc (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
95300|NCT01998477|O8|Outcome|TIV_Non Naive (9 to <18 Years)|Vaccine nonnaïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
95301|NCT01998477|O7|Outcome|TIV_Non Naive (3 to <9 Years)|Vaccine non naïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
95302|NCT01998477|O6|Outcome|TIV_Naive (3 to <9 Years)|Vaccine naïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
95303|NCT01998477|O5|Outcome|TIVc_Non Naive (9 to <18 Years)|Vaccine nonnaïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
95304|NCT01998477|O4|Outcome|TIVc_Non Naive (3 to <9 Years)|Vaccine non naïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
95305|NCT01998477|O3|Outcome|TIVc_Naive (3 to <9 Years)|Vaccine naïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
95306|NCT01998477|O2|Outcome|TIV (3 to <18 Years)|Vaccine naïve and non-naive subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
95307|NCT01998477|O1|Outcome|TIVc (3 to <18 Years)|Vaccine naïve and non-naive subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
95308|NCT01998477|O14|Outcome|TIV_Non Naive (9 to <18 Years)|Vaccine nonnaïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
95309|NCT01998477|O13|Outcome|TIVc_Non Naive (9 to <18 Years)|Vaccine nonnaïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
95310|NCT01998477|O12|Outcome|TIV_Naive_inj 2 (≥ 6 to < 9 Years)|Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
95311|NCT01998477|O11|Outcome|TIV_Naive_inj 1 (≥ 6 to < 9 Years)|Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
95312|NCT01998477|O10|Outcome|TIV_Non Naive_inj 1 (≥ 6 to < 9 Years)|Vaccine non-naïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
95313|NCT01998477|O9|Outcome|TIVc_Naive_inj 2 (≥ 6 to < 9 Years)|Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
95314|NCT01998477|O8|Outcome|TIVc_Naive_inj 1 (≥ 6 to < 9 Years)|Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
95315|NCT01998477|O7|Outcome|TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)|Vaccine non-naïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
95316|NCT01998477|O6|Outcome|TIV_naive_inj 2 (3 to <6 Years)|Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
95317|NCT01998477|O5|Outcome|TIV_naive_inj 1 (3 to <6 Years)|Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
95318|NCT01998477|O4|Outcome|TIV_Non naive_inj 1 (3 to <6 Years)|Vaccine nonnaïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
95319|NCT01998477|O3|Outcome|TIVc_naive_inj 2 (3 to <6 Years)|Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
95320|NCT01998477|O2|Outcome|TIVc_naive_inj 1 (3 to <6 Years)|Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
95321|NCT01998477|O1|Outcome|TIVc_Non naive_inj 1 (3 to <6 Years)|Vaccine non-naïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
95322|NCT01998477|O4|Outcome|TIV_inj 2 (3 to <18 Years)|Vaccine naïve and non-naive subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
95323|NCT01998477|O3|Outcome|TIV_inj 1 (3 to <18 Years)|Vaccine naïve and non-naive subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
95324|NCT01998477|O2|Outcome|TIVc_inj 2 (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
95325|NCT01998477|O1|Outcome|TIVc _inj 1 (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
95326|NCT01998477|E3|Reported Event|Total|Total Number of subjects
95327|NCT01998477|E2|Reported Event|TIV (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
95328|NCT01998477|E1|Reported Event|TIVc (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc).
95329|NCT01998438|B4|Baseline|Total|Total of all reporting groups
95330|NCT01998438|B3|Baseline|Large Dose|"30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
95331|NCT01998438|B2|Baseline|Medium Dose|"20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
95332|NCT01998438|B1|Baseline|Small Dose|"10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
95333|NCT01998438|P3|Participant Flow|Large Dose|"30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
95334|NCT01998438|P2|Participant Flow|Medium Dose|"20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
95335|NCT01998438|P1|Participant Flow|Small Dose|"10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
95336|NCT01998438|O3|Outcome|Large Dose|"30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
95337|NCT01998438|O2|Outcome|Medium Dose|"20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
95338|NCT01998438|O1|Outcome|Small Dose|"10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
95339|NCT01998438|E3|Reported Event|Large Dose|"30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
95340|NCT01998438|E2|Reported Event|Medium Dose|"20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
95341|NCT01998438|E1|Reported Event|Small Dose|"10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
95342|NCT01998399|B3|Baseline|Total|Total of all reporting groups
95343|NCT01998399|B2|Baseline|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
95344|NCT01998399|B1|Baseline|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
95345|NCT01998399|P2|Participant Flow|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
95346|NCT01998399|P1|Participant Flow|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
95347|NCT01998399|O2|Outcome|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
95348|NCT01998399|O1|Outcome|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
95349|NCT01998399|O2|Outcome|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
95350|NCT01998399|O1|Outcome|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
95351|NCT01998399|O2|Outcome|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
95352|NCT01998399|O1|Outcome|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
95353|NCT01998399|O2|Outcome|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
95354|NCT01998399|O1|Outcome|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
95355|NCT01998399|O2|Outcome|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
95356|NCT01998399|O1|Outcome|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
95357|NCT01998399|O2|Outcome|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
95358|NCT01998399|O1|Outcome|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
95359|NCT01998399|O2|Outcome|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
95360|NCT01998399|O1|Outcome|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
96953|NCT01990794|O2|Outcome|Prestudy - Left|Values of the left eye for select ONH variables
95361|NCT01998399|O2|Outcome|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
95362|NCT01998399|O1|Outcome|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
95363|NCT01998399|O2|Outcome|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
95364|NCT01998399|O1|Outcome|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
95365|NCT01998399|O2|Outcome|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
95366|NCT01998399|O1|Outcome|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
95367|NCT01998399|O2|Outcome|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
95368|NCT01998399|O1|Outcome|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
95369|NCT01998399|O2|Outcome|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
95370|NCT01998399|O1|Outcome|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
95371|NCT01998399|O2|Outcome|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
95372|NCT01998399|O1|Outcome|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
95373|NCT01998399|O2|Outcome|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
95374|NCT01998399|O1|Outcome|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
95375|NCT01998399|E2|Reported Event|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
95376|NCT01998399|E1|Reported Event|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
95377|NCT01998360|B3|Baseline|Total|Total of all reporting groups
95378|NCT01998360|B2|Baseline|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
95379|NCT01998360|B1|Baseline|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
95380|NCT01998360|P2|Participant Flow|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
95381|NCT01998360|P1|Participant Flow|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
95382|NCT01998360|O2|Outcome|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
95383|NCT01998360|O1|Outcome|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
95384|NCT01998360|O2|Outcome|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
95385|NCT01998360|O1|Outcome|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
95386|NCT01998360|O2|Outcome|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
95387|NCT01998360|O1|Outcome|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
95388|NCT01998360|O2|Outcome|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
95389|NCT01998360|O1|Outcome|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
95390|NCT01998360|O2|Outcome|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
95391|NCT01998360|O1|Outcome|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
95392|NCT01998360|E2|Reported Event|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
95393|NCT01998360|E1|Reported Event|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
95394|NCT01998269|B1|Baseline|Adult Patients With Diabetes and Hypertension|There are no study arms. This was a cross-sectional study to develop a scale.
95395|NCT01998269|P1|Participant Flow|Adult Patients With Diabetes and Hypertension|English-speaking, adult patients with diabetes and hypertension. There are no study arms - this was a cross-sectional study to develop and validate a measure of medication self-management skills. A total of 210 patients were recruited. 17 participated in focus groups to help develop the tool. The other 193 participated in item performance testing. The results of item performance testing are reported here.
95396|NCT01998269|O1|Outcome|Adult Patients With Diabetes and Hypertension|English-speaking, adult patients with diabetes and hypertension were enrolled in the study. There are no study arms.
95397|NCT01998269|E1|Reported Event|Adult Patients With Diabetes and Hypertension|There are no study arms. This was a cross-sectional study to develop a medication self-management scale.
95398|NCT01997905|B1|Baseline|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
95399|NCT01997905|P1|Participant Flow|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
95400|NCT01997905|O1|Outcome|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
95401|NCT01997905|O1|Outcome|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
95402|NCT01997905|O1|Outcome|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
95403|NCT01997905|O1|Outcome|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
95404|NCT01997905|O1|Outcome|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
95405|NCT01997905|O1|Outcome|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
95406|NCT01997905|E1|Reported Event|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
95407|NCT01997892|B1|Baseline|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEG epoetin beta immediately prior to being switched to darbepoetin alfa.
95408|NCT01997892|P1|Participant Flow|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEGylated (PEG) epoetin beta immediately prior to being switched to darbepoetin alfa.
95409|NCT01997892|O2|Outcome|Excursions > 12.0 g/dL|Hemoglobin excursions above 12.0 g/dL
95410|NCT01997892|O1|Outcome|Excursions <10.0 g/dL|Hemoglobin excursions below 10.0 g/dL
95411|NCT01997892|O2|Outcome|Post-switch Period|From the date of the switch to darbepoetin alfa, until up to 6 months.
95412|NCT01997892|O1|Outcome|Pre-switch Period|From 3 months prior to the switch until the date of the switch to darbepoetin alfa.
95413|NCT01997892|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEG epoetin beta immediately prior to being switched to darbepoetin alfa.
95414|NCT01997892|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEG epoetin beta immediately prior to being switched to darbepoetin alfa.
95415|NCT01997892|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEG epoetin beta immediately prior to being switched to darbepoetin alfa.
95416|NCT01997892|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEG epoetin beta immediately prior to being switched to darbepoetin alfa.
95417|NCT01997892|E2|Reported Event|Post-switch Period|From the date of the switch to darbepoetin alfa, until up to 6 months.
95418|NCT01997892|E1|Reported Event|Pre-switch Period|From 3 months prior to the switch until the date of the switch to darbepoetin alfa.
95419|NCT01997723|B1|Baseline|OSA Testing|"Cross-over design, single group/arm~Interventions:~One polysomnography one laboratory Portable monitoring simultaneously with polysomnography one home Portable monitoring"
95420|NCT01997723|P1|Participant Flow|Experimental|"Cross-over design, single group/arm~Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA."
95421|NCT01997723|O1|Outcome|OSA Testing|"Cross-over design, single group/arm~Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA."
95422|NCT01997723|O1|Outcome|OSA Testing|"Cross-over design, single group/arm~Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA."
95423|NCT01997723|O1|Outcome|OSA Testing|"Cross-over design, single group/arm~Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA."
95424|NCT01997723|E1|Reported Event|OSA Testing|"Cross-over design, single group/arm~Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA."
95425|NCT01997567|B3|Baseline|Total|Total of all reporting groups
95436|NCT01997437|O1|Outcome|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
95614|NCT01996709|O2|Outcome|Clear Care, Left Eye|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
95426|NCT01997567|B2|Baseline|Grp 2 Placebo Block|"Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)~Placebo: Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)"
95427|NCT01997567|B1|Baseline|Grp 1 Ropivacaine Block|"Group 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)~Ropivacaine: Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)"
95428|NCT01997567|P2|Participant Flow|Grp 2 Placebo Block|"Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)~Placebo: Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)"
95429|NCT01997567|P1|Participant Flow|Grp 1 Ropivacaine Block|"Group 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)~Ropivacaine: Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)"
95430|NCT01997567|O2|Outcome|Grp 2 Placebo Block|"Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)~Placebo: Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)"
95431|NCT01997567|O1|Outcome|Grp 1 Ropivacaine Block|"Group 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)~Ropivacaine: Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)"
95432|NCT01997567|E2|Reported Event|Grp 2 Placebo Block|"Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)~Placebo: Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)"
95433|NCT01997567|E1|Reported Event|Grp 1 Ropivacaine Block|"Group 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)~Ropivacaine: Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)"
95434|NCT01997437|B1|Baseline|Tissue-engineered Airway Transplantation|"Stem-cell seeded bioartificial tracheal scaffold~Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ"
95435|NCT01997437|P1|Participant Flow|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
95437|NCT01997437|O1|Outcome|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
95438|NCT01997437|O1|Outcome|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
95439|NCT01997437|O1|Outcome|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
95440|NCT01997437|E1|Reported Event|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
95441|NCT01997411|B6|Baseline|Total|Total of all reporting groups
95442|NCT01997411|B5|Baseline|12 to <17 Years Old IN/IM Cohort|Participants who were 12 to < 17 years old at the time of enrollment into the study randomized to receive either intramuscular glucagon or intranasal glucagon at two separate visits. Order of these visits was randomized.
95443|NCT01997411|B4|Baseline|8 to <12 Years Old Intranasal Glucagon Cohort|Participants who were 8 to < 12 years old at the time of enrollment into the study randomized to receive 2.0 or 3.0 mg of intranasal glucagon at two separate visits. Order of these visits was randomized.
95444|NCT01997411|B3|Baseline|8 to <12 Years Old Intramuscular Glucagon Cohort|Participants who were 8 to < 12 years old at the time of enrollment into the study randomized to receive only the intramuscular glucagon at one visit.
95445|NCT01997411|B2|Baseline|4 to <8 Years Old Intranasal Glucagon Cohort|Participants who were 4 to < 8 years old at the time of enrollment into the study randomized to receive 2.0 or 3.0 mg of intranasal glucagon at two separate visits. Order of these visits was randomized.
95446|NCT01997411|B1|Baseline|4 to <8 Years Old Intramuscular Glucagon Cohort|Participants who were 4 to < 8 years old at the time of enrollment into the study randomized to receive only the intramuscular glucagon at one visit.
95447|NCT01997411|P8|Participant Flow|12 to <17 Years IM Glucagon 1st Visit/IN Glucagon 2nd Visit|"At the first visit, participants who weighed at least 25 kg (55) lbs were given an intramuscular (IM) dose of 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.~At the second visit, an intranasal (IN) glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation."
95448|NCT01997411|P7|Participant Flow|12 to <17 Years IN Glucagon 1st Visit/IM Glucagon 2nd Visit|"At the first visit, an intranasal (IN) glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.~At the second visit, participants who weighed at least 25 kg (55) lbs were given an intramuscular (IM) dose of 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution."
95449|NCT01997411|P6|Participant Flow|8 to <12 Years IN Glucagon 3.0 mg 1st Visit/2.0 mg 2nd Visit|"At the first visit, an intranasal (IN) glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.~At the second visit, an IN glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation."
95450|NCT01997411|P5|Participant Flow|8 to <12 Years IN Glucagon 2.0 mg 1st Visit/3.0 mg 2nd Visit|"At the first visit, an intranasal (IN) glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.~At the second visit, an IN glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation."
95451|NCT01997411|P4|Participant Flow|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
95452|NCT01997411|P3|Participant Flow|4 to <8 Years IN Glucagon 3.0 mg 1st Visit/2.0 mg 2nd Visit|"At the first visit, an intranasal (IN) glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.~At the second visit, an IN glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation."
95453|NCT01997411|P2|Participant Flow|4 to <8 Years IN Glucagon 2.0 mg 1st Visit/3.0 mg 2nd Visit|"At the first visit, an intranasal (IN) glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.~At the second visit, an IN glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation."
95610|NCT01996709|O2|Outcome|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
95454|NCT01997411|P1|Participant Flow|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were given an intramuscular (IM) dose of 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
95455|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95456|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
95457|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95458|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95459|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
95460|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95461|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95462|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
95463|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95464|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
95465|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95466|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95467|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
95468|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95469|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95470|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
95471|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95472|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
95473|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95474|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95475|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
95476|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95477|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95478|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
95479|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95480|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
95481|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95482|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95483|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
95484|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95485|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95486|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
95487|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95488|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
95489|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95490|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95491|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
95492|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95493|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95494|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
95495|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95496|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
95497|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95498|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95499|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
95500|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95501|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95502|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
95503|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95504|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
95505|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95506|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95507|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
95508|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95509|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95510|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
95511|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95512|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
95513|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95514|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95515|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
95516|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95517|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95518|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
95519|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95520|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
95521|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95522|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95523|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
95524|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95525|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95526|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
95527|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95528|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
95529|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95530|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95531|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
95532|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95533|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95534|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
95535|NCT01997411|E8|Reported Event|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95536|NCT01997411|E7|Reported Event|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
95537|NCT01997411|E6|Reported Event|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95538|NCT01997411|E5|Reported Event|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95539|NCT01997411|E4|Reported Event|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
95540|NCT01997411|E3|Reported Event|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95541|NCT01997411|E2|Reported Event|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
95542|NCT01997411|E1|Reported Event|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
95543|NCT01997398|B1|Baseline|DBS Under General Anesthesia|Patients with advanced Parkinson's disease who underwent bilateral globus pallidus interna (GPi) deep brain stimulation surgery under general anesthesia without the use of microelectrode recordings or intraoperative stimulation.
95544|NCT01997398|P1|Participant Flow|Bilateral GPi DBS Surgery Under General Anesthesia|Patients underwent bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.
95545|NCT01997398|O2|Outcome|Post - DBS Bilateral GPi DBS Surgery Under General Anesthesia|Patients who underwent bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.
95546|NCT01997398|O1|Outcome|Pre-DBS Bilateral GPi DBS Surgery Under General Anesthesia|Patients scheduled for bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.
95547|NCT01997398|O4|Outcome|"Post-DBS Bilateral GPi DBS Under General Anesthesia On Med"|"On medication scores of patients who underwent bilateral GPi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy."
95548|NCT01997398|O3|Outcome|"Pre-DBS Bilateral GPi DBS Under General Anesthesia On Med"|"On medication scores of patients scheduled for bilateral GPi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy."
95549|NCT01997398|O2|Outcome|"Post-DBS Bilateral GPi DBS Under General Anesthesia Off Med"|"Off medication UPDRS III scores of patients who underwent bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy."
95550|NCT01997398|O1|Outcome|"Pre-DBS Bilateral GPi DBS Under General Anesthesia Off Med"|"Off  medication UPDRS III scores of patients scheduled for bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.~Off medication ."
95551|NCT01997398|E1|Reported Event|Bilateral GPi DBS Surgery Under General Anesthesia|Patients underwent bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.
95552|NCT01997229|B3|Baseline|Total|Total of all reporting groups
95553|NCT01997229|B2|Baseline|Placebo|"Induction phase: 3 vials of study drug (placebo) weekly for 4 doses (every 7 days ± 2 days) followed by 4 vials of study drug (placebo) 1 week later for the fifth dose (Week 4).~Maintenance phase: 4 vials of study drug (placebo) every 2 weeks (14 days ± 2 days) from the fifth dose onwards (Week 6 through Week 26)."
95554|NCT01997229|B1|Baseline|Eculizumab|"Induction phase: 3 vials of study drug (equivalent to 900 mg of eculizumab) weekly for 4 doses (every 7 days ± 2 days) followed by 4 vials of study drug (equivalent to 1200 mg of eculizumab) 1 week later for the fifth dose (Week 4).~Maintenance phase: 4 vials of study drug (equivalent to 1200 mg of eculizumab) every 2 weeks (14 days ± 2 days) from the fifth dose onwards (Week 6 through Week 26)."
95555|NCT01997229|P2|Participant Flow|Placebo|"Induction phase: 3 vials of study drug (placebo) weekly for 4 doses (every 7 days ± 2 days) followed by 4 vials of study drug (placebo) 1 week later for the fifth dose (Week 4).~Maintenance phase: 4 vials of study drug (placebo) every 2 weeks (14 days ± 2 days) from the fifth dose onwards (Week 6 through Week 26)."
95611|NCT01996709|O1|Outcome|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
95612|NCT01996709|O4|Outcome|Habitual MPS, Left Eye|Habitual contact lens solution used with habitual contact lenses for 90 days
95556|NCT01997229|P1|Participant Flow|Eculizumab|"Induction phase: 3 vials of study drug (equivalent to 900 mg of eculizumab) weekly for 4 doses (every 7 days ± 2 days) followed by 4 vials of study drug (equivalent to 1200 mg of eculizumab) 1 week later for the fifth dose (Week 4).~Maintenance phase: 4 vials of study drug (equivalent to 1200 mg of eculizumab) every 2 weeks (14 days ± 2 days) from the fifth dose onwards (Week 6 through Week 26)."
95557|NCT01997229|O2|Outcome|Placebo|"Induction phase: 3 vials of study drug (placebo) weekly for 4 doses (every 7 days ± 2 days) followed by 4 vials of study drug (placebo) 1 week later for the fifth dose (Week 4).~Maintenance phase: 4 vials of study drug (placebo) every 2 weeks (14 days ± 2 days) from the fifth dose onwards (Week 6 through Week 26)."
95558|NCT01997229|O1|Outcome|Eculizumab|"Induction phase: 3 vials of study drug (equivalent to 900 mg of eculizumab) weekly for 4 doses (every 7 days ± 2 days) followed by 4 vials of study drug (equivalent to 1200 mg of eculizumab) 1 week later for the fifth dose (Week 4).~Maintenance phase: 4 vials of study drug (equivalent to 1200 mg of eculizumab) every 2 weeks (14 days ± 2 days) from the fifth dose onwards (Week 6 through Week 26)."
95559|NCT01997229|E2|Reported Event|Placebo|"Induction phase: 3 vials of study drug (placebo) weekly for 4 doses (every 7 days ± 2 days) followed by 4 vials of study drug (placebo) 1 week later for the fifth dose (Week 4).~Maintenance phase: 4 vials of study drug (placebo) every 2 weeks (14 days ± 2 days) from the fifth dose onwards (Week 6 through Week 26)."
95560|NCT01997229|E1|Reported Event|Eculizumab|"Induction phase: 3 vials of study drug (equivalent to 900 mg of eculizumab) weekly for 4 doses (every 7 days ± 2 days) followed by 4 vials of study drug (equivalent to 1200 mg of eculizumab) 1 week later for the fifth dose (Week 4).~Maintenance phase: 4 vials of study drug (equivalent to 1200 mg of eculizumab) every 2 weeks (14 days ± 2 days) from the fifth dose onwards (Week 6 through Week 26)."
95561|NCT01997216|B1|Baseline|Overall|Delefilcon A multifocal contact lenses and lotrafilcon B multifocal contact lenses, worn as randomized for 9 hours each.
95562|NCT01997216|P2|Participant Flow|AOAMF, Then Delefilcon A MF|Lotrafilcon B multifocal contact lenses, followed by delefilcon A multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days.
95563|NCT01997216|P1|Participant Flow|Delefilcon A MF, Then AOAMF|Delefilcon A multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days.
95564|NCT01997216|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
95565|NCT01997216|O1|Outcome|Delefilcon A MF|Delefilcon A multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
95566|NCT01997216|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
95567|NCT01997216|O1|Outcome|Delefilcon A MF|Delefilcon A multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
95568|NCT01997216|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
95569|NCT01997216|O1|Outcome|Delefilcon A MF|Delefilcon A multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
95570|NCT01997216|E2|Reported Event|AOAMF|Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
95571|NCT01997216|E1|Reported Event|Delefilcon A MF|Delefilcon A multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
95572|NCT01996904|B3|Baseline|Total|Total of all reporting groups
95573|NCT01996904|B2|Baseline|Arthroscopic Debridement|Anterosuperior portal was made for debridement (capsulectomy and anterior bursectomy). A systematic release of the glenohumeral ligaments and the overlying subscapularis bursa was also performed. The superior aspect of the tendon was freed. from the surrounding structures (the coracohumeral and superior glenohumeral ligaments). The middle glenohumeral ligament was always released to identify the upper border of the subscapularis tendon.
95574|NCT01996904|B1|Baseline|Arthroscopic Repair|"Lateral-anterosuperior portal (“Miracle Portal”) was used to repair subscapularis tendon. Bursa anterior to the subscapularis tendon was usually removed for the accurate positioning of the suture-hook. Subscapularis tendon was released, pulled and sutured with suture-hook. One or two suture anchors of Modified Mason-Allen technique was used to secure the tendon.~arthroscopic repair: If the subscapularis tendon was not sufficiently mobile, further anterior interval release between subscapularis and scapula was performed. LHB (long head of biceps tendon) was either treated with a biceps tenodesis or by tenotomy when there was tear or subluxation of it. The footprint area of the subscapularis tendon, which is trapezoidal in shape on the proximal part of the lesser tuberosity, was thoroughly cleaned of soft tissue and meticulous bone preparation was done prior to placement of anchor sutures."
95575|NCT01996904|P2|Participant Flow|Arthroscopic Debridement|Anterosuperior portal was made for debridement (capsulectomy and anterior bursectomy). A systematic release of the glenohumeral ligaments and the overlying subscapularis bursa was also performed. The superior aspect of the tendon was freed from the surrounding structures (the coracohumeral and superior glenohumeral ligaments). The middle glenohumeral ligament was always released to identify the upper border of the subscapularis tendon.
95576|NCT01996904|P1|Participant Flow|Arthroscopic Repair|"Lateral-anterosuperior portal (“Miracle Portal”) was used to repair subscapularis tendon. Bursa anterior to the subscapularis tendon was usually removed for the accurate positioning of the suture-hook. Subscapularis tendon was released, pulled and sutured with suture-hook. One or two suture anchors of Modified Mason-Allen technique was used to secure the tendon.~If the subscapularis tendon was not sufficiently mobile, further anterior interval release between subscapularis and scapula was performed. LHB (long head of biceps tendon) was either treated with a biceps tenodesis or by tenotomy when there was tear or subluxation of it. The footprint area of the subscapularis tendon, which is trapezoidal in shape on the proximal part of the lesser tuberosity, was thoroughly cleaned of soft tissue and meticulous bone preparation was done prior to placement of anchor sutures."
95577|NCT01996904|O2|Outcome|Arthroscopic Debridement|Anterosuperior portal was made for debridement (capsulectomy and anterior bursectomy). A systematic release of the glenohumeral ligaments and the overlying subscapularis bursa was also performed. The superior aspect of the tendon was freed. from the surrounding structures (the coracohumeral and superior glenohumeral ligaments). The middle glenohumeral ligament was always released to identify the upper border of the subscapularis tendon.
95613|NCT01996709|O3|Outcome|Habitual MPS, Right Eye|Habitual contact lens solution used with habitual contact lenses for 90 days
95578|NCT01996904|O1|Outcome|Arthroscopic Repair|"Lateral-anterosuperior portal (“Miracle Portal”) was used to repair subscapularis tendon. Bursa anterior to the subscapularis tendon was usually removed for the accurate positioning of the suture-hook. Subscapularis tendon was released, pulled and sutured with suture-hook. One or two suture anchors of Modified Mason-Allen technique was used to secure the tendon.~arthroscopic repair: If the subscapularis tendon was not sufficiently mobile, further anterior interval release between subscapularis and scapula was performed. LHB (long head of biceps tendon) was either treated with a biceps tenodesis or by tenotomy when there was tear or subluxation of it. The footprint area of the subscapularis tendon, which is trapezoidal in shape on the proximal part of the lesser tuberosity, was thoroughly cleaned of soft tissue and meticulous bone preparation was done prior to placement of anchor sutures."
95579|NCT01996904|E2|Reported Event|Arthroscopic Debridement|Anterosuperior portal was made for debridement (capsulectomy and anterior bursectomy). A systematic release of the glenohumeral ligaments and the overlying subscapularis bursa was also performed. The superior aspect of the tendon was freed. from the surrounding structures (the coracohumeral and superior glenohumeral ligaments). The middle glenohumeral ligament was always released to identify the upper border of the subscapularis tendon.
95580|NCT01996904|E1|Reported Event|Arthroscopic Repair|"Lateral-anterosuperior portal (“Miracle Portal”) was used to repair subscapularis tendon. Bursa anterior to the subscapularis tendon was usually removed for the accurate positioning of the suture-hook. Subscapularis tendon was released, pulled and sutured with suture-hook. One or two suture anchors of Modified Mason-Allen technique was used to secure the tendon.~arthroscopic repair: If the subscapularis tendon was not sufficiently mobile, further anterior interval release between subscapularis and scapula was performed. LHB (long head of biceps tendon) was either treated with a biceps tenodesis or by tenotomy when there was tear or subluxation of it. The footprint area of the subscapularis tendon, which is trapezoidal in shape on the proximal part of the lesser tuberosity, was thoroughly cleaned of soft tissue and meticulous bone preparation was done prior to placement of anchor sutures."
95581|NCT01996813|B1|Baseline|Compression Hose|"All patients in this observational cohort study will wear compression hose during shoulder arthroscopy in the beach chair position to determine the effect of the stockings on the incidence of cerebral desaturation events during surgery.~Compression Hose: Intervention in this case is placement of compression hose on patients"
95582|NCT01996813|P1|Participant Flow|Compression Hose|"All patients in this observational cohort study will wear compression hose during shoulder arthroscopy in the beach chair position to determine the effect of the stockings on the incidence of cerebral desaturation events during surgery.~Compression Hose: Intervention in this case is placement of compression hose on patients"
95583|NCT01996813|O1|Outcome|Compression Hose|"All patients in this observational cohort study will wear compression hose during shoulder arthroscopy in the beach chair position to determine the effect of the stockings on the incidence of cerebral desaturation events during surgery.~Compression Hose: Intervention in this case is placement of compression hose on patients"
95584|NCT01996813|O1|Outcome|Compression Hose|"All patients in this observational cohort study will wear compression hose during shoulder arthroscopy in the beach chair position to determine the effect of the stockings on the incidence of cerebral desaturation events during surgery.~Compression Hose: Intervention in this case is placement of compression hose on patients"
95585|NCT01996813|E1|Reported Event|Compression Hose|"All patients in this observational cohort study will wear compression hose during shoulder arthroscopy in the beach chair position to determine the effect of the stockings on the incidence of cerebral desaturation events during surgery.~Compression Hose: Intervention in this case is placement of compression hose on patients"
95586|NCT01996748|B3|Baseline|Total|Total of all reporting groups
95587|NCT01996748|B2|Baseline|Placebo|"Two administrations daily for 7 days~Placebo: Two administrations daily for 7 days"
95588|NCT01996748|B1|Baseline|DF277|"Two administrations daily for 7 days~DF277: Two administrations daily for 7 days"
95589|NCT01996748|P2|Participant Flow|Placebo|"Two administrations daily for 7 days~Placebo: Two administrations daily for 7 days"
95590|NCT01996748|P1|Participant Flow|DF277|"Two administrations daily for 7 days~DF277: Two administrations daily for 7 days"
95591|NCT01996748|O2|Outcome|Placebo|"Two administrations daily for 7 days~Placebo: Two administrations daily for 7 days"
95592|NCT01996748|O1|Outcome|DF277|"Two administrations daily for 7 days~DF277: Two administrations daily for 7 days"
95593|NCT01996748|O2|Outcome|Placebo|"Two administrations daily for 7 days~Placebo: Two administrations daily for 7 days"
95594|NCT01996748|O1|Outcome|DF277|"Two administrations daily for 7 days~DF277: Two administrations daily for 7 days"
95595|NCT01996748|O2|Outcome|Placebo|Two administrations daily for 7 days
95596|NCT01996748|O1|Outcome|DF277|Two administrations daily for 7 days
95597|NCT01996748|O2|Outcome|Placebo|"Two administrations daily for 7 days~Placebo: Two administrations daily for 7 days"
95598|NCT01996748|O1|Outcome|DF277|"Two administrations daily for 7 days~DF277: Two administrations daily for 7 days"
95599|NCT01996748|E2|Reported Event|Placebo|"Two administrations daily for 7 days~Placebo: Two administrations daily for 7 days"
95600|NCT01996748|E1|Reported Event|DF277|"Two administrations daily for 7 days~DF277: Two administrations daily for 7 days"
95601|NCT01996709|B3|Baseline|Total|Total of all reporting groups
95602|NCT01996709|B2|Baseline|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
95603|NCT01996709|B1|Baseline|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
95604|NCT01996709|P2|Participant Flow|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
95605|NCT01996709|P1|Participant Flow|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
95606|NCT01996709|O2|Outcome|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
95607|NCT01996709|O1|Outcome|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
95608|NCT01996709|O2|Outcome|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
95609|NCT01996709|O1|Outcome|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
96954|NCT01990794|O1|Outcome|Prestudy - Right|Values of the right eye for select ONH variables
95615|NCT01996709|O1|Outcome|Clear Care, Right Eye|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
95616|NCT01996709|E2|Reported Event|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
95617|NCT01996709|E1|Reported Event|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
95618|NCT01996657|B4|Baseline|Total|Total of all reporting groups
95619|NCT01996657|B3|Baseline|Low Intensity Without Adjustment|"The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),~Warfarin"
95620|NCT01996657|B2|Baseline|Low Intensity and Adjusted by Elevated D-dimer|"The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.~Warfarin"
95621|NCT01996657|B1|Baseline|Standard Intensity of Anticoagulation|"After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).~Warfarin"
95622|NCT01996657|P3|Participant Flow|Low Intensity Without Adjustment|"The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),~Warfarin"
95623|NCT01996657|P2|Participant Flow|Low Intensity and Adjusted by Elevated D-dimer|"The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.~Warfarin"
95624|NCT01996657|P1|Participant Flow|Standard Intensity of Anticoagulation|"After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).~Warfarin"
95625|NCT01996657|O3|Outcome|Low Intensity Without Adjustment|"The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),~Warfarin"
95626|NCT01996657|O2|Outcome|Low Intensity and Adjusted by Elevated D-dimer|"The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.~Warfarin"
95627|NCT01996657|O1|Outcome|Standard Intensity of Anticoagulation|"After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).~Warfarin"
95628|NCT01996657|O3|Outcome|Low Intensity Without Adjustment|"The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),~Warfarin"
95629|NCT01996657|O2|Outcome|Low Intensity and Adjusted by Elevated D-dimer|"The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.~Warfarin"
95630|NCT01996657|O1|Outcome|Standard Intensity of Anticoagulation|"After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).~Warfarin"
95631|NCT01996657|O3|Outcome|Low Intensity Without Adjustment|"The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),~Warfarin"
95632|NCT01996657|O2|Outcome|Low Intensity and Adjusted by Elevated D-dimer|"The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.~Warfarin"
95633|NCT01996657|O1|Outcome|Standard Intensity of Anticoagulation|"After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).~Warfarin"
95634|NCT01996657|E3|Reported Event|Low Intensity Without Adjustment|"The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),~Warfarin"
95635|NCT01996657|E2|Reported Event|D-dimer-guided Adjustmentd of Anticoagutlation Intensity|"The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.~Warfarin"
95636|NCT01996657|E1|Reported Event|Standard Intensity of Anticoagulation|"After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).~Warfarin"
95637|NCT01996644|B3|Baseline|Total|Total of all reporting groups
95638|NCT01996644|B2|Baseline|Placebo|Placebo Group
95639|NCT01996644|B1|Baseline|Setraline|"250 mg DCS (setraline) versus placebo~Sertaline"
95640|NCT01996644|P2|Participant Flow|Placebo|Placebo group
95641|NCT01996644|P1|Participant Flow|Setraline|"250 mg DCS (setraline)~Sertaline"
95642|NCT01996644|O3|Outcome|All Combined|Setraline and Placebo groups
95643|NCT01996644|O2|Outcome|Placebo|"Placebo group~Placebo vs Setraline: Placebo"
95644|NCT01996644|O1|Outcome|Setraline|"250 mg DCS (setraline) versus placebo~Placebo vs Setraline: Placebo"
95645|NCT01996644|O2|Outcome|Placebo|"Placebo group~Sertaline"
95646|NCT01996644|O1|Outcome|Setraline|"250 mg DCS (setraline) versus placebo~Sertaline"
95647|NCT01996644|O2|Outcome|Placebo|"Placebo group~Placebo vs Setraline: Placebo"
95648|NCT01996644|O1|Outcome|Setraline|"250 mg DCS (setraline) versus placebo~Placebo vs Setraline: Placebo"
95649|NCT01996644|E2|Reported Event|Placebo|"Placebo group~Sertaline"
95650|NCT01996644|E1|Reported Event|Setraline|"250 mg DCS (setraline) versus placebo~Sertaline"
95651|NCT01996410|B9|Baseline|Total|Total of all reporting groups
95652|NCT01996410|B8|Baseline|Chemotherapy 4 No Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
95796|NCT01995201|O1|Outcome|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
95653|NCT01996410|B7|Baseline|Chemotherapy 3 No Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
95654|NCT01996410|B6|Baseline|Chemotherapy 2 No Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
95655|NCT01996410|B5|Baseline|Chemotherapy 1 No Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
95656|NCT01996410|B4|Baseline|Chemotherapy 4 Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
95657|NCT01996410|B3|Baseline|Chemotherapy 3 Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
95658|NCT01996410|B2|Baseline|Chemotherapy 2 Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
95659|NCT01996410|B1|Baseline|Chemotherapy 1 Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
95660|NCT01996410|P8|Participant Flow|Chemotherapy 4 No Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
95661|NCT01996410|P7|Participant Flow|Chemotherapy 3 No Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
95662|NCT01996410|P6|Participant Flow|Chemotherapy 2 No Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
95663|NCT01996410|P5|Participant Flow|Chemotherapy 1 No Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
95797|NCT01995201|O2|Outcome|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95664|NCT01996410|P4|Participant Flow|Chemotherapy 4 Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
95665|NCT01996410|P3|Participant Flow|Chemotherapy 3 Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
95666|NCT01996410|P2|Participant Flow|Chemotherapy 2 Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
95667|NCT01996410|P1|Participant Flow|Chemotherapy 1 Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
95668|NCT01996410|O2|Outcome|Standard of Care- No Acupuncture|
95669|NCT01996410|O1|Outcome|Acupuncture|
95670|NCT01996410|E8|Reported Event|Chemotherapy 4 No Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
95671|NCT01996410|E7|Reported Event|Chemotherapy 4 Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
95672|NCT01996410|E6|Reported Event|Chemotherapy 3 No Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
95673|NCT01996410|E5|Reported Event|Chemotherapy 3 Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
95674|NCT01996410|E4|Reported Event|Chemotherapy 2 No Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
95675|NCT01996410|E3|Reported Event|Chemotherapy 2 Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
95676|NCT01996410|E2|Reported Event|Chemotherapy 1 No Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
96186|NCT01994629|E2|Reported Event|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
95677|NCT01996410|E1|Reported Event|Chemotherapy 1 Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
95678|NCT01996332|B1|Baseline|Erlotinib 150 mg/Day|Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
95679|NCT01996332|P1|Participant Flow|Erlotinib 150 Milligrams Per Day (mg/Day)|Participants received erlotinib 150 milligrams/day (mg/day), orally, until progressive disease or unacceptable toxicity.
95680|NCT01996332|O1|Outcome|Erlotinib 150 mg/Day|Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
95681|NCT01996332|O1|Outcome|Erlotinib 150 mg/Day|Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
95682|NCT01996332|O1|Outcome|Erlotinib 150 mg/Day|Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
95683|NCT01996332|E1|Reported Event|Erlotinib 150 mg/Day|Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
95684|NCT01996319|B3|Baseline|Total|Total of all reporting groups
95685|NCT01996319|B2|Baseline|Placebo Then QVA149|Placebo once a day during 22 days cross-over to QVA149 once a day for 22 days
95686|NCT01996319|B1|Baseline|QVA149 Then Placebo|QVA149 once a day during 22 days cross-over to placebo once a day for up to 22 days
95687|NCT01996319|P2|Participant Flow|Placebo Then QVA149|Placebo once a day during 22 days cross-over to QVA149 once a day for 22 days
95688|NCT01996319|P1|Participant Flow|QVA149 Then Placebo|QVA149 once a day during 22 days cross-over to placebo once a day for up to 22 days
95689|NCT01996319|O2|Outcome|Placebo|
95690|NCT01996319|O1|Outcome|QVA149|
95691|NCT01996319|O2|Outcome|Placebo|
95692|NCT01996319|O1|Outcome|QVA149|
95693|NCT01996319|O2|Outcome|Placebo|
95694|NCT01996319|O1|Outcome|QVA149|
95695|NCT01996319|O2|Outcome|Placebo|
95696|NCT01996319|O1|Outcome|QVA149|
95697|NCT01996319|O2|Outcome|Placebo|
95698|NCT01996319|O1|Outcome|QVA149|
95699|NCT01996319|O2|Outcome|Placebo|
95700|NCT01996319|O1|Outcome|QVA149|
95701|NCT01996319|O2|Outcome|Placebo|
95702|NCT01996319|O1|Outcome|QVA149|
95703|NCT01996319|O2|Outcome|Placebo|
95704|NCT01996319|O1|Outcome|QVA149|
95705|NCT01996319|E2|Reported Event|Placebo Then QVA149|Placebo once a day during 22 days cross-over to QVA149 once a day for 22 days
95706|NCT01996319|E1|Reported Event|QVA149 Then Placebo|QVA149 once a day during 22 days cross-over to placebo once a day for up to 22 days
95707|NCT01995513|B1|Baseline|Enzalutamide 160 mg|Participants received enzalutamide 160 mg as four 40 mg capsules, orally once daily until disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first.
95708|NCT01995513|P3|Participant Flow|Placebo+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95709|NCT01995513|P2|Participant Flow|Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed prostate-specific antigen (PSA) progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95710|NCT01995513|P1|Participant Flow|Enzalutamide 160 mg|Participants received enzalutamide 160 milligram (mg) as four 40 mg capsules, orally once daily until disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first.
95711|NCT01995513|O3|Outcome|Placebo+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95712|NCT01995513|O2|Outcome|Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95713|NCT01995513|O1|Outcome|Enzalutamide 160 mg|Participants received enzalutamide 160 mg as four 40 mg capsules, orally once daily until disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first.
95714|NCT01995513|O3|Outcome|Placebo+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95715|NCT01995513|O2|Outcome|Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95716|NCT01995513|O1|Outcome|Enzalutamide 160 mg|Participants received enzalutamide 160 mg as four 40 mg capsules, orally once daily until disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first.
95717|NCT01995513|O3|Outcome|Placebo+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95718|NCT01995513|O2|Outcome|Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95719|NCT01995513|O1|Outcome|Enzalutamide 160 mg|Participants received enzalutamide 160 mg as four 40 mg capsules, orally once daily until disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first.
95720|NCT01995513|O3|Outcome|Placebo+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95721|NCT01995513|O2|Outcome|Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95722|NCT01995513|O1|Outcome|Enzalutamide 160 mg|Participants received enzalutamide 160 mg as four 40 mg capsules, orally once daily until disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first.
95723|NCT01995513|O2|Outcome|Placebo+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95798|NCT01995201|O1|Outcome|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95804|NCT01995201|O1|Outcome|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
95724|NCT01995513|O1|Outcome|Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95725|NCT01995513|O2|Outcome|Placebo+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95726|NCT01995513|O1|Outcome|Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95727|NCT01995513|O2|Outcome|Placebo+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95728|NCT01995513|O1|Outcome|Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95729|NCT01995513|O2|Outcome|Placebo+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95730|NCT01995513|O1|Outcome|Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95731|NCT01995513|O2|Outcome|Placebo+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95732|NCT01995513|O1|Outcome|Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95733|NCT01995513|O2|Outcome|Placebo+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95799|NCT01995201|O2|Outcome|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
95734|NCT01995513|O1|Outcome|Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95735|NCT01995513|O2|Outcome|Placebo+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95736|NCT01995513|O1|Outcome|Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95737|NCT01995513|O2|Outcome|Placebo+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95738|NCT01995513|O1|Outcome|Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95739|NCT01995513|O2|Outcome|Placebo+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95740|NCT01995513|O1|Outcome|Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95741|NCT01995513|O2|Outcome|Placebo+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95742|NCT01995513|O1|Outcome|Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95743|NCT01995513|O2|Outcome|Placebo+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95800|NCT01995201|O1|Outcome|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
97187|NCT01989169|O1|Outcome|Midazolam|Administered as a single oral 6 mg dose on Day 1.
95744|NCT01995513|O1|Outcome|Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95745|NCT01995513|O2|Outcome|Placebo+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95746|NCT01995513|O1|Outcome|Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95747|NCT01995513|O2|Outcome|Placebo+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95748|NCT01995513|O1|Outcome|Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95749|NCT01995513|E3|Reported Event|Placebo+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95750|NCT01995513|E2|Reported Event|Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg|Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
95751|NCT01995513|E1|Reported Event|Enzalutamide 160 mg|Participants received enzalutamide 160 mg as four 40 mg capsules, orally once daily until disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or patient withdrawal, whichever occurs first. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first.
95752|NCT01995461|B1|Baseline|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)~bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
95753|NCT01995461|P1|Participant Flow|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)~bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
95801|NCT01995201|O2|Outcome|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95805|NCT01995201|O5|Outcome|Phase 2 Arm D: Non Responders|Patients who didn't achieve any therapeutic response up to week 24 and were discontinued from the study.
97312|NCT01988129|O2|Outcome|Control|Current practice
95754|NCT01995461|O1|Outcome|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)~bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
95755|NCT01995461|O1|Outcome|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)~bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
95756|NCT01995461|O1|Outcome|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)~bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
95757|NCT01995461|E1|Reported Event|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)~bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
95758|NCT01995357|B1|Baseline|All Subjects|Baseline data is summarized for all subjects
95759|NCT01995357|P6|Participant Flow|First Standard Product, Then Coloplast Test B|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.~The test sequence in this arm is:~Standard product; Coloplast Test B; Coloplast Test A; ; Training + Coloplast Test B; Training + Coloplast Test A~Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.~Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
95760|NCT01995357|P5|Participant Flow|First Standard Product; Then Coloplast Test A|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.~The test sequence in this arm is:~Standard product; Coloplast Test A; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B~Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.~Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
95761|NCT01995357|P4|Participant Flow|First Coloplast Test B; Then Standard Product|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.~The test sequence in this arm is:~Coloplast Test b; Standard product; Coloplast Test A; Training + Coloplast Test B; Training + Coloplast Test A~Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.~Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
95762|NCT01995357|P3|Participant Flow|First Coloplast Test B; Then Colopast Test A|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.~The test sequence in this arm is:~Coloplast Test B; Coloplast Test A; Standard product; Training + Coloplast Test B; Training + Coloplast Test A~Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.~Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
95763|NCT01995357|P2|Participant Flow|First Coloplast Test A; Then Standard Product|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.~The test sequence in this arm is:~Coloplast Test A; Standard product; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B~Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.~Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
95802|NCT01995201|O1|Outcome|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95803|NCT01995201|O2|Outcome|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
95764|NCT01995357|P1|Participant Flow|First Coloplast Teast A; Then Coloplast Test B|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.~The test sequence in this arm is:~Coloplast Test A; Coloplast Test B; Standard product; Training + Coloplast Test A; Training + Coloplast Test B~Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.~Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
95765|NCT01995357|O11|Outcome|Ileostomy, Standard Care (SenSura)|
95766|NCT01995357|O10|Outcome|Ileostomy, Training + Test B|
95767|NCT01995357|O9|Outcome|Ileostomy, Test B|
95768|NCT01995357|O8|Outcome|Ileostomy, Training + Test A|
95769|NCT01995357|O7|Outcome|Ileostomy, Test A|
95770|NCT01995357|O6|Outcome|Colostomy, Standard Care (SenSura)|
95771|NCT01995357|O5|Outcome|Colostomy, Standard Care (SenSura Mio)|
95772|NCT01995357|O4|Outcome|Colostomy, Training + Test B|
95773|NCT01995357|O3|Outcome|Colostomy, Test B|
95774|NCT01995357|O2|Outcome|Colostomy, Training + Test A|
95775|NCT01995357|O1|Outcome|Colostomy ,Test A|
95776|NCT01995357|E3|Reported Event|Standard Care|Standard care was used only during part one of the study. i.e. for one period only.
95777|NCT01995357|E2|Reported Event|Test B + Training Test B|"Test Product B was used both during part one of the study (Test B) and part two (Training Test B) hence adverse events are reported collectively for Test Product B.~Consequently, Test Product B is used for two periods compared to Standard care which has been used for only one."
95778|NCT01995357|E1|Reported Event|Test A + Training Test A|"Test Product A was used both during part one of the study (Test A) and part two (Training Test A) hence adverse events are reported collectively for Test Product A.~Consequently, Test Product A is used for two periods compared to Standard care which has been used for only one."
95779|NCT01995201|B3|Baseline|Total|Total of all reporting groups
95780|NCT01995201|B2|Baseline|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
95781|NCT01995201|B1|Baseline|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
95782|NCT01995201|P7|Participant Flow|Phase 2 Arm D: Non Responders|Non responders, safety population.
95783|NCT01995201|P6|Participant Flow|Phase 2 Arm C: Moderate EULAR Response at Week 24|Patients who achieved moderate EULAR response at Week 24 continued in the study with initial treatment as per investigator’s judgement.
95784|NCT01995201|P5|Participant Flow|Phase 2 Arm B: Participants With Low Disease Activity|Participants who did not achieve sustained clinical remission at Week 20 and Week 24 but achieve low disease activity (DAS 28-ESR ≤ 3.2) at Week 24 continued with initial treatment of tocilizumab as a single fixed dose monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95785|NCT01995201|P4|Participant Flow|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieved sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95786|NCT01995201|P3|Participant Flow|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieved sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95787|NCT01995201|P2|Participant Flow|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
95788|NCT01995201|P1|Participant Flow|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
95789|NCT01995201|O2|Outcome|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95790|NCT01995201|O1|Outcome|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95791|NCT01995201|O2|Outcome|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
95792|NCT01995201|O1|Outcome|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
95793|NCT01995201|O2|Outcome|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95794|NCT01995201|O1|Outcome|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95795|NCT01995201|O2|Outcome|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
96187|NCT01994629|E1|Reported Event|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
95806|NCT01995201|O4|Outcome|Phase 2 Arm C: Moderate EULAR Response at Week 24|Patients who achieved moderate EULAR response at Week 24 continued in the study with initial treatment as per investigator’s judgement.
95807|NCT01995201|O3|Outcome|Phase 2 Arm B: Participants With Low Disease Activity|Participants who did not achieve sustained clinical remission at Week 20 and Week 24 but achieve low disease activity (DAS 28-ESR ≤ 3.2) at Week 24 continued with initial treatment of tocilizumab as a single fixed dose monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95808|NCT01995201|O2|Outcome|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95809|NCT01995201|O1|Outcome|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95810|NCT01995201|O2|Outcome|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
95811|NCT01995201|O1|Outcome|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
95812|NCT01995201|O5|Outcome|Phase 2 Arm D: Non Responders|Patients who didn't achieve any therapeutic response up to week 24 and were discontinued from the study.
95813|NCT01995201|O4|Outcome|Phase 2 Arm C: Moderate EULAR Response at Week 24|Patients who achieved moderate EULAR response at Week 24 continued in the study with initial treatment as per investigator’s judgement.
95814|NCT01995201|O3|Outcome|Phase 2 Arm B: Participants With Low Disease Activity|Participants who did not achieve sustained clinical remission at Week 20 and Week 24 but achieve low disease activity (DAS 28-ESR ≤ 3.2) at Week 24 continued with initial treatment of tocilizumab as a single fixed dose monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. Participants who achieved moderate EULAR response at Week 24 continued in the study with initial treatment as per investigator’s judgement.
95815|NCT01995201|O2|Outcome|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95816|NCT01995201|O1|Outcome|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95817|NCT01995201|O2|Outcome|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
95818|NCT01995201|O1|Outcome|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
95819|NCT01995201|O5|Outcome|Phase 2 Arm D: Non Responders|Patients who didn't achieve any therapeutic response up to week 24 and were discontinued from the study.
95820|NCT01995201|O4|Outcome|Phase 2 Arm C: Moderate EULAR Response at Week 24|Patients who achieved moderate EULAR response at Week 24 continued in the study with initial treatment as per investigator’s judgement.
95821|NCT01995201|O3|Outcome|Phase 2 Arm B: Participants With Low Disease Activity|Participants who did not achieve sustained clinical remission at Week 20 and Week 24 but achieve low disease activity (DAS 28-ESR ≤ 3.2) at Week 24 continued with initial treatment of tocilizumab as a single fixed dose monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95822|NCT01995201|O2|Outcome|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95823|NCT01995201|O1|Outcome|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95824|NCT01995201|O2|Outcome|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
95825|NCT01995201|O1|Outcome|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
95826|NCT01995201|O5|Outcome|Phase 2 Arm D: Non Responders|Patients who didn't achieve any therapeutic response up to week 24 and were discontinued from the study.
95827|NCT01995201|O4|Outcome|Phase 2 Arm C: Moderate EULAR Response at Week 24|Patients who achieved moderate EULAR response at Week 24 continued in the study with initial treatment as per investigator’s judgement.
95828|NCT01995201|O3|Outcome|Phase 2 Arm B: Participants With Low Disease Activity|Participants who did not achieve sustained clinical remission at Week 20 and Week 24 but achieve low disease activity (DAS 28-ESR ≤ 3.2) at Week 24 continued with initial treatment of tocilizumab as a single fixed dose monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95829|NCT01995201|O2|Outcome|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95855|NCT01995201|O2|Outcome|Phase 2 Arm A1- Combination Therapy - qw|Participants who achieved sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95830|NCT01995201|O1|Outcome|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95831|NCT01995201|O2|Outcome|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
95832|NCT01995201|O1|Outcome|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
95833|NCT01995201|O2|Outcome|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95834|NCT01995201|O1|Outcome|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95835|NCT01995201|O2|Outcome|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
95836|NCT01995201|O1|Outcome|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
95837|NCT01995201|O2|Outcome|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95838|NCT01995201|O1|Outcome|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95839|NCT01995201|O2|Outcome|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
95840|NCT01995201|O1|Outcome|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
95841|NCT01995201|O2|Outcome|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95842|NCT01995201|O1|Outcome|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95843|NCT01995201|O2|Outcome|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
95844|NCT01995201|O1|Outcome|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
95845|NCT01995201|O2|Outcome|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95846|NCT01995201|O1|Outcome|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95847|NCT01995201|O2|Outcome|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
95848|NCT01995201|O1|Outcome|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
95849|NCT01995201|O2|Outcome|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95850|NCT01995201|O1|Outcome|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95851|NCT01995201|O2|Outcome|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
95852|NCT01995201|O1|Outcome|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
95853|NCT01995201|O4|Outcome|Phase 2 Arm A2 - Combination Therapy - q2w|Participants who achieved sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every 2 weeks in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95854|NCT01995201|O3|Outcome|Phase 2 Arm A2 - Monotherapy - q2w|Participants who achieved sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every 2 weeks monotherapy from Week 24 to Week 48.
95856|NCT01995201|O1|Outcome|Phase 2 Arm A1 - Monotherapy - qw|Participants who achieved sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy from Week 24 to Week 48.
95857|NCT01995201|O2|Outcome|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95858|NCT01995201|O1|Outcome|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95859|NCT01995201|O2|Outcome|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
95860|NCT01995201|O1|Outcome|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
95861|NCT01995201|O2|Outcome|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95862|NCT01995201|O1|Outcome|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95863|NCT01995201|O2|Outcome|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
95864|NCT01995201|O1|Outcome|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
95865|NCT01995201|O2|Outcome|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95866|NCT01995201|O1|Outcome|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95867|NCT01995201|O2|Outcome|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
95868|NCT01995201|O1|Outcome|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
95869|NCT01995201|O2|Outcome|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95870|NCT01995201|O1|Outcome|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95871|NCT01995201|O2|Outcome|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
95872|NCT01995201|O1|Outcome|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
95873|NCT01995201|O2|Outcome|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95874|NCT01995201|O1|Outcome|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95875|NCT01995201|O2|Outcome|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
95876|NCT01995201|O1|Outcome|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
95877|NCT01995201|O2|Outcome|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95878|NCT01995201|O1|Outcome|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95879|NCT01995201|O2|Outcome|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
95880|NCT01995201|O1|Outcome|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
95881|NCT01995201|O2|Outcome|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95882|NCT01995201|O1|Outcome|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95883|NCT01995201|O2|Outcome|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95884|NCT01995201|O1|Outcome|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95885|NCT01995201|O2|Outcome|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95886|NCT01995201|O1|Outcome|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95887|NCT01995201|O2|Outcome|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
95888|NCT01995201|O1|Outcome|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
95889|NCT01995201|E7|Reported Event|Phase 2 Arm D: Non Responders|Patients who didn't achieve any therapeutic response up to week 24 and were discontinued from the study.
95890|NCT01995201|E6|Reported Event|Phase 2 Arm C: Moderate EULAR Response at Week 24|Patients who achieved moderate EULAR response at Week 24 continued in the study with initial treatment as per investigator’s judgement.
95891|NCT01995201|E5|Reported Event|Phase 2 Arm B: Participants With Low Disease Activity|Participants who did not achieve sustained clinical remission at Week 20 and Week 24 but achieve low disease activity (DAS 28-ESR ≤ 3.2) at Week 24 continued with initial treatment of tocilizumab as a single fixed dose monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95892|NCT01995201|E4|Reported Event|Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w)|Participants who achieved sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95893|NCT01995201|E3|Reported Event|Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw)|Participants who achieved sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48.
95894|NCT01995201|E2|Reported Event|Phase 1: Combination Therapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks.
95895|NCT01995201|E1|Reported Event|Phase 1: Tocilizumab Monotherapy|Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks.
95896|NCT01995136|B1|Baseline|TRAVATAN Z|Ophthalmic solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
95897|NCT01995136|P1|Participant Flow|TRAVATAN Z|Ophthalmic Solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
95898|NCT01995136|O1|Outcome|TRAVATAN Z|Ophthalmic Solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
95899|NCT01995136|E1|Reported Event|TRAVATAN Z|Ophthalmic Solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
95900|NCT01995071|B13|Baseline|Total|Total of all reporting groups
95901|NCT01995071|B12|Baseline|Arm 12 Non-cirrhotic|ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95902|NCT01995071|B11|Baseline|Arm 11 Non-cirrhotic|ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95903|NCT01995071|B10|Baseline|Arm 10 Compensated Cirrhotic|ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95904|NCT01995071|B9|Baseline|Arm 9 Non-cirrhotic|ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95905|NCT01995071|B8|Baseline|Arm 8 Non-cirrhotic|ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95906|NCT01995071|B7|Baseline|Arm 7 Non-cirrhotic|ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95907|NCT01995071|B6|Baseline|Arm 6 Non-cirrhotic|ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
96180|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
95908|NCT01995071|B5|Baseline|Arm 5 Compensated Cirrhotic|ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95909|NCT01995071|B4|Baseline|Arm 4 Non-cirrhotic|ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95910|NCT01995071|B3|Baseline|Arm 3 Non-cirrhotic|ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95911|NCT01995071|B2|Baseline|Arm 2 Non-cirrhotic|ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95912|NCT01995071|B1|Baseline|Arm 1 Non-cirrhotic|ABT-493 Dose A (100 mg once daily [QD]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95913|NCT01995071|P12|Participant Flow|Arm 12 Non-cirrhotic|ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95914|NCT01995071|P11|Participant Flow|Arm 11 Non-cirrhotic|ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95915|NCT01995071|P10|Participant Flow|Arm 10 Compensated Cirrhotic|ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95916|NCT01995071|P9|Participant Flow|Arm 9 Non-cirrhotic|ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95917|NCT01995071|P8|Participant Flow|Arm 8 Non-cirrhotic|ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95918|NCT01995071|P7|Participant Flow|Arm 7 Non-cirrhotic|ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95919|NCT01995071|P6|Participant Flow|Arm 6 Non-cirrhotic|ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95920|NCT01995071|P5|Participant Flow|Arm 5 Compensated Cirrhotic|ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95921|NCT01995071|P4|Participant Flow|Arm 4 Non-cirrhotic|ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95922|NCT01995071|P3|Participant Flow|Arm 3 Non-cirrhotic|ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95923|NCT01995071|P2|Participant Flow|Arm 2 Non-cirrhotic|ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95924|NCT01995071|P1|Participant Flow|Arm 1 Non-cirrhotic|ABT-493 Dose A (100 mg once daily [QD]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95925|NCT01995071|O12|Outcome|Arm 12 Non-cirrhotic|ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95926|NCT01995071|O11|Outcome|Arm 11 Non-cirrhotic|ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95927|NCT01995071|O10|Outcome|Arm 10 Compensated Cirrhotic|ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95928|NCT01995071|O9|Outcome|Arm 9 Non-cirrhotic|ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95929|NCT01995071|O8|Outcome|Arm 8 Non-cirrhotic|ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95930|NCT01995071|O7|Outcome|Arm 7 Non-cirrhotic|ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95931|NCT01995071|O6|Outcome|Arm 6 Non-cirrhotic|ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95932|NCT01995071|O5|Outcome|Arm 5 Compensated Cirrhotic|ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
96181|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
95933|NCT01995071|O4|Outcome|Arm 4 Non-cirrhotic|ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95934|NCT01995071|O3|Outcome|Arm 3 Non-cirrhotic|ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95935|NCT01995071|O2|Outcome|Arm 2 Non-cirrhotic|ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95936|NCT01995071|O1|Outcome|Arm 1 Non-cirrhotic|ABT-493 Dose A (100 mg once daily [QD]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95937|NCT01995071|O12|Outcome|Arm 12 Non-cirrhotic|ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95938|NCT01995071|O11|Outcome|Arm 11 Non-cirrhotic|ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95939|NCT01995071|O10|Outcome|Arm 10 Compensated Cirrhotic|ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95940|NCT01995071|O9|Outcome|Arm 9 Non-cirrhotic|ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95941|NCT01995071|O8|Outcome|Arm 8 Non-cirrhotic|ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95942|NCT01995071|O7|Outcome|Arm 7 Non-cirrhotic|ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95943|NCT01995071|O6|Outcome|Arm 6 Non-cirrhotic|ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95944|NCT01995071|O5|Outcome|Arm 5 Compensated Cirrhotic|ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95945|NCT01995071|O4|Outcome|Arm 4 Non-cirrhotic|ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95946|NCT01995071|O3|Outcome|Arm 3 Non-cirrhotic|ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95947|NCT01995071|O2|Outcome|Arm 2 Non-cirrhotic|ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95948|NCT01995071|O1|Outcome|Arm 1 Non-cirrhotic|ABT-493 Dose A (100 mg once daily [QD]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95949|NCT01995071|O12|Outcome|Arm 12 Non-cirrhotic|ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95950|NCT01995071|O11|Outcome|Arm 11 Non-cirrhotic|ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95951|NCT01995071|O10|Outcome|Arm 10 Compensated Cirrhotic|ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95952|NCT01995071|O9|Outcome|Arm 9 Non-cirrhotic|ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95953|NCT01995071|O8|Outcome|Arm 8 Non-cirrhotic|ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95954|NCT01995071|O7|Outcome|Arm 7 Non-cirrhotic|ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95955|NCT01995071|O6|Outcome|Arm 6 Non-cirrhotic|ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95956|NCT01995071|O5|Outcome|Arm 5 Compensated Cirrhotic|ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95957|NCT01995071|O4|Outcome|Arm 4 Non-cirrhotic|ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95958|NCT01995071|O3|Outcome|Arm 3 Non-cirrhotic|ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95959|NCT01995071|O2|Outcome|Arm 2 Non-cirrhotic|ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95960|NCT01995071|O1|Outcome|Arm 1 Non-cirrhotic|ABT-493 Dose A (100 mg once daily [QD]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95961|NCT01995071|O10|Outcome|Arm 12 Non-cirrhotic|ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95962|NCT01995071|O9|Outcome|Arm 11 Non-cirrhotic|ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95963|NCT01995071|O8|Outcome|Arm 9 Non-cirrhotic|ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95964|NCT01995071|O7|Outcome|Arm 8 Non-cirrhotic|ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95965|NCT01995071|O6|Outcome|Arm 7 Non-cirrhotic + Arm 10 Compensated Cirrhotic|ABT-530 Dose B or Dose E (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95966|NCT01995071|O5|Outcome|Arm 6 Non-cirrhotic|ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95967|NCT01995071|O4|Outcome|Arm 4 Non-cirrhotic + Arm 5 Compensated Cirrhotic|ABT-493 Dose D or Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95968|NCT01995071|O3|Outcome|Arm 3 Non-cirrhotic|ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95969|NCT01995071|O2|Outcome|Arm 2 Non-cirrhotic|ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95970|NCT01995071|O1|Outcome|Arm 1 Non-cirrhotic|ABT-493 Dose A (100 mg once daily [QD]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95971|NCT01995071|E11|Reported Event|Arm 11 Non-cirrhotic|ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95972|NCT01995071|E10|Reported Event|Arm 10 Compensated Cirrhotic|ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95973|NCT01995071|E9|Reported Event|Arm 9 Non-cirrhotic|ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95974|NCT01995071|E8|Reported Event|Arm 8 Non-cirrhotic|ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95975|NCT01995071|E7|Reported Event|Arm 7 Non-cirrhotic|ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95976|NCT01995071|E6|Reported Event|Arm 6 Non-cirrhotic|ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95977|NCT01995071|E5|Reported Event|Arm 5 Compensated Cirrhotic|ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95978|NCT01995071|E4|Reported Event|Arm 4 Non-cirrhotic|ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95979|NCT01995071|E3|Reported Event|Arm 3 Non-cirrhotic|ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95980|NCT01995071|E2|Reported Event|Arm 2 Non-cirrhotic|ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95981|NCT01995071|E1|Reported Event|Arm 1 Non-cirrhotic|ABT-493 Dose A (100 mg once daily [QD]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
95982|NCT01995045|B3|Baseline|Total|Total of all reporting groups
95983|NCT01995045|B2|Baseline|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
95984|NCT01995045|B1|Baseline|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
95985|NCT01995045|P2|Participant Flow|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
95986|NCT01995045|P1|Participant Flow|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
95987|NCT01995045|O2|Outcome|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
95988|NCT01995045|O1|Outcome|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
95989|NCT01995045|O2|Outcome|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
95990|NCT01995045|O1|Outcome|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
95991|NCT01995045|O2|Outcome|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
95992|NCT01995045|O1|Outcome|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
95993|NCT01995045|O2|Outcome|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
95994|NCT01995045|O1|Outcome|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
95995|NCT01995045|E2|Reported Event|Bupivicaine|"Retrobulbar anesthesia with Bupivicaine Hydrochloride~Bupivicaine Hydrochloride: Retrobulbar anesthesia"
95996|NCT01995045|E1|Reported Event|Bupivicaine & Triamcinolone|"Retrobulbar anesthesia with Bupivicaine Hydrochloride and Triamcinolone Acetonide~Triamcinolone: Retrobulbar anesthesia~Bupivicaine Hydrochloride: Retrobulbar anesthesia"
95997|NCT01994993|B6|Baseline|Total|Total of all reporting groups
95998|NCT01994993|B5|Baseline|Group 5|"metronidazole, clindamycin, or piperacillin-tazobactam~metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
95999|NCT01994993|B4|Baseline|Group 4|"Per standard of care antibiotics, and Metronidazole~standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96000|NCT01994993|B3|Baseline|Group 3|"piperacillin-tazobactam and gentamicin~gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96001|NCT01994993|B2|Baseline|Group 2|"ampicillin and gentamicin and clindamycin~ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96002|NCT01994993|B1|Baseline|Group 1|"Ampicillin and gentamycin and metronidazole~ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96003|NCT01994993|P5|Participant Flow|Group 5|"metronidazole, clindamycin, or piperacillin-tazobactam~metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96004|NCT01994993|P4|Participant Flow|Group 4|"Per standard of care antibiotics, and Metronidazole~standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96005|NCT01994993|P3|Participant Flow|Group 3|"piperacillin-tazobactam and gentamicin~gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96006|NCT01994993|P2|Participant Flow|Group 2|"ampicillin and gentamicin and clindamycin~ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96007|NCT01994993|P1|Participant Flow|Group 1|"Ampicillin and gentamycin and metronidazole~ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96008|NCT01994993|O4|Outcome|Group 4|"Per standard of care antibiotics, and Metronidazole~standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96009|NCT01994993|O3|Outcome|Group 3|"piperacillin-tazobactam and gentamicin~gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96010|NCT01994993|O2|Outcome|Group 2|"ampicillin and gentamicin and clindamycin~ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96011|NCT01994993|O1|Outcome|Group 1|"Ampicillin and gentamycin and metronidazole~ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96012|NCT01994993|O4|Outcome|Group 4|"Per standard of care antibiotics, and Metronidazole~standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96013|NCT01994993|O3|Outcome|Group 3|"piperacillin-tazobactam and gentamicin~gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96014|NCT01994993|O2|Outcome|Group 2|"ampicillin and gentamicin and clindamycin~ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96015|NCT01994993|O1|Outcome|Group 1|"Ampicillin and gentamycin and metronidazole~ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96016|NCT01994993|O4|Outcome|Group 4|"Per standard of care antibiotics, and Metronidazole~standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96017|NCT01994993|O3|Outcome|Group 3|"piperacillin-tazobactam and gentamicin~gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96018|NCT01994993|O2|Outcome|Group 2|"ampicillin and gentamicin and clindamycin~ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96019|NCT01994993|O1|Outcome|Group 1|"Ampicillin and gentamycin and metronidazole~ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96020|NCT01994993|O4|Outcome|Group 4|"Per standard of care antibiotics, and Metronidazole~standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96021|NCT01994993|O3|Outcome|Group 3|"piperacillin-tazobactam and gentamicin~gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96022|NCT01994993|O2|Outcome|Group 2|"ampicillin and gentamicin and clindamycin~ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96023|NCT01994993|O1|Outcome|Group 1|"Ampicillin and gentamycin and metronidazole~ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96024|NCT01994993|O4|Outcome|Group 4|"Per standard of care antibiotics, and Metronidazole~standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96025|NCT01994993|O3|Outcome|Group 3|"piperacillin-tazobactam and gentamicin~gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96026|NCT01994993|O2|Outcome|Group 2|"ampicillin and gentamicin and clindamycin~ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96027|NCT01994993|O1|Outcome|Group 1|"Ampicillin and gentamycin and metronidazole~ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96028|NCT01994993|O4|Outcome|Group 4|"Per standard of care antibiotics, and Metronidazole~standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96029|NCT01994993|O3|Outcome|Group 3|"piperacillin-tazobactam and gentamicin~gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96030|NCT01994993|O2|Outcome|Group 2|"ampicillin and gentamicin and clindamycin~ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96031|NCT01994993|O1|Outcome|Group 1|"Ampicillin and gentamycin and metronidazole~ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96032|NCT01994993|O4|Outcome|Group 4|"Per standard of care antibiotics, and Metronidazole~standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96033|NCT01994993|O3|Outcome|Group 3|"piperacillin-tazobactam and gentamicin~gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96034|NCT01994993|O2|Outcome|Group 2|"ampicillin and gentamicin and clindamycin~ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96035|NCT01994993|O1|Outcome|Group 1|"Ampicillin and gentamycin and metronidazole~ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96036|NCT01994993|O4|Outcome|Group 4|"Per standard of care antibiotics, and Metronidazole~standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96037|NCT01994993|O3|Outcome|Group 3|"piperacillin-tazobactam and gentamicin~gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96038|NCT01994993|O2|Outcome|Group 2|"ampicillin and gentamicin and clindamycin~ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96039|NCT01994993|O1|Outcome|Group 1|"Ampicillin and gentamycin and metronidazole~ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96040|NCT01994993|O4|Outcome|Group 4|"Per standard of care antibiotics, and Metronidazole~standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96041|NCT01994993|O3|Outcome|Group 3|"piperacillin-tazobactam and gentamicin~gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96042|NCT01994993|O2|Outcome|Group 2|"ampicillin and gentamicin and clindamycin~ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96043|NCT01994993|O1|Outcome|Group 1|"Ampicillin and gentamycin and metronidazole~ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96044|NCT01994993|O4|Outcome|Group 4|"Per standard of care antibiotics, and Metronidazole~standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96045|NCT01994993|O3|Outcome|Group 3|"piperacillin-tazobactam and gentamicin~gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96046|NCT01994993|O2|Outcome|Group 2|"ampicillin and gentamicin and clindamycin~ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96047|NCT01994993|O1|Outcome|Group 1|"Ampicillin and gentamycin and metronidazole~ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96048|NCT01994993|O5|Outcome|Group 5|"metronidazole, clindamycin, or piperacillin-tazobactam~metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96049|NCT01994993|O4|Outcome|Group 4|"Per standard of care antibiotics, and Metronidazole~standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96050|NCT01994993|O3|Outcome|Group 3|"piperacillin-tazobactam and gentamicin~gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96051|NCT01994993|O2|Outcome|Group 2|"ampicillin and gentamicin and clindamycin~ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96052|NCT01994993|O1|Outcome|Group 1|"Ampicillin and gentamycin and metronidazole~ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96053|NCT01994993|E5|Reported Event|Group 5|"metronidazole, clindamycin, or piperacillin-tazobactam~metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96054|NCT01994993|E4|Reported Event|Group 4|"Per standard of care antibiotics, and Metronidazole~standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96055|NCT01994993|E3|Reported Event|Group 3|"piperacillin-tazobactam and gentamicin~gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96056|NCT01994993|E2|Reported Event|Group 2|"ampicillin and gentamicin and clindamycin~ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96057|NCT01994993|E1|Reported Event|Group 1|"Ampicillin and gentamycin and metronidazole~ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)"
96058|NCT01994902|B1|Baseline|Overall Study|The investigation is a cross-over investigation therefore the baseline data is given for the overall study population
96059|NCT01994902|P2|Participant Flow|First SenSura Convex Light; Then Coloplast Test Product|"The subjects test:~test period 1: SenSura Convex Light test period 2: Coloplast test product"
96060|NCT01994902|P1|Participant Flow|First Coloplast Test Product; Then SenSura Convex Light|"The subjects test:~test period 1: Coloplast test product test period 2: SenSura Convex Light"
96061|NCT01994902|O2|Outcome|SenSura Convex Light|The leakage results obtained while subjects were testing SenSura Convex Light
96062|NCT01994902|O1|Outcome|Coloplast Test Product|Leakage results obtained while subjects tested the Coloplast test product
96063|NCT01994902|E2|Reported Event|SenSura Convex Light|Adverse events reported by subjects testing SenSura Convex Light
96064|NCT01994902|E1|Reported Event|Coloplast Test Product|Adverse events reported by subjects testing Coloplast test product
96065|NCT01994876|B1|Baseline|Overall Study|All the subjects in one group
96182|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
96183|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
96066|NCT01994876|P2|Participant Flow|First Coloplast Test 2, Then Coloplast Test 1|"The subjects first test their own product to collect baseline measurements~The subjects are randomised to first test Coloplast Test 2 and thereafter Coloplast Test 1~Coloplast Test 1: Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance~Coloplast Test 2: Coloplast Test 2 is a newly developed 1-piece convex ostomy appliance"
96067|NCT01994876|P1|Participant Flow|First Coloplast Test 1, Then Coloplast Test 2|"The subjects first test their own product to collect a baseline measurement~The subjects are randomised to first test Coloplast Test 1 and thereafter Coloplast Test 2~Coloplast Test 1: Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance~Coloplast Test 2: Coloplast Test 2 is a newly developed 1-piece convex ostomy appliance"
96068|NCT01994876|O3|Outcome|Basline - Own Product|Data from subject testing own product. Measures baseline leakage
96069|NCT01994876|O2|Outcome|Coloplast Test 2|Results from subjects testing Coloplast Test 2
96070|NCT01994876|O1|Outcome|Coloplast Test 1|Results from subjects testing Coloplast Test 1
96071|NCT01994876|E3|Reported Event|Basline - Own Product|Data from subject testing own product. Measures baseline leakage
96072|NCT01994876|E2|Reported Event|Coloplast Test 2|Results from subjects testing Coloplast Test 2
96073|NCT01994876|E1|Reported Event|Coloplast Test 1|Results from subjects testing Coloplast Test 1
96074|NCT01994863|B1|Baseline|All Subjects|
96075|NCT01994863|P2|Participant Flow|First Standard Care (See Below); Then Coloplast Test Product|"The subjects are randomised to test Standard care first and thereafter test Coloplast test product.~Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece.~The three Standard Care products were tested in a 1:1:1 randomisation.~Coloplast Test product: Coloplast test product is a newly developed 1-piece ostomy appliance~Standard Care: Standard care consists of three already marketed 1-piece ostomy products~Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima"
96076|NCT01994863|P1|Participant Flow|First Coloplast Test Product; Then Standard Care (See Below)|"The subjects are randomised to test Coloplast Test product first and thereafter test Standard Care.~Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece.~The three Standard Care products were tested in a 1:1:1 randomisation.~Coloplast Test product: Coloplast test product is a newly developed 1-piece ostomy appliance~Standard Care: Standard care consists of three already marketed 1-piece ostomy products~Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima"
96077|NCT01994863|O2|Outcome|Standard Care|
96078|NCT01994863|O1|Outcome|Coloplast Test Product|
96079|NCT01994863|E2|Reported Event|Standard Care|
96080|NCT01994863|E1|Reported Event|Coloplast Test Product|
96081|NCT01994837|B1|Baseline|ABT-199|Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
96082|NCT01994837|P1|Participant Flow|ABT-199|Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
96083|NCT01994837|O1|Outcome|ABT-199|Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
96084|NCT01994837|O1|Outcome|ABT-199|Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
96085|NCT01994837|O1|Outcome|ABT-199|Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
96086|NCT01994837|O1|Outcome|ABT-199|Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
96087|NCT01994837|O1|Outcome|ABT-199|Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
96088|NCT01994837|O1|Outcome|ABT-199|Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
96089|NCT01994837|O1|Outcome|ABT-199|Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
96090|NCT01994837|O1|Outcome|ABT-199|Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
96091|NCT01994837|O1|Outcome|ABT-199|Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
96092|NCT01994837|O1|Outcome|ABT-199|Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
96184|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
96185|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
96093|NCT01994837|E1|Reported Event|ABT-199|Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
96094|NCT01994785|B5|Baseline|Total|Total of all reporting groups
96095|NCT01994785|B4|Baseline|Colonoscopy Capnography Blinded|"Capnographic monitoring during Colonoscopy - Data made available to study staff only if necessary for safety reasons~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
96096|NCT01994785|B3|Baseline|Colonoscopy Capnography Open|"Capnographic monitoring during Colonoscopy - Data made available to study staff throughout procedure~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
96097|NCT01994785|B2|Baseline|EGD Capnography Blinded|"Capnographic monitoring during EGD - Data made available to study staff only if necessary for safety reasons~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
96098|NCT01994785|B1|Baseline|EGD Capnography Open|"Capnographic monitoring during EGD - Data made available to study staff throughout procedure~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
96099|NCT01994785|P4|Participant Flow|Colonoscopy Capnography Blinded|"Capnographic monitoring during Colonoscopy - Data made available to study staff only if necessary for safety reasons~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
96100|NCT01994785|P3|Participant Flow|Colonoscopy Capnography Open|"Capnographic monitoring during Colonoscopy - Data made available to study staff throughout procedure~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
96101|NCT01994785|P2|Participant Flow|EGD Capnography Blinded|"Capnographic monitoring during EGD - Data made available to study staff only if necessary for safety reasons~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
96102|NCT01994785|P1|Participant Flow|EGD Capnography Open|"Capnographic monitoring during EGD - Data made available to study staff throughout procedure~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
96103|NCT01994785|O4|Outcome|Colonoscopy Capnography Blinded|"Capnographic monitoring during Colonoscopy - Data made available to study staff only if necessary for safety reasons~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
96104|NCT01994785|O3|Outcome|Colonoscopy Capnography Open|"Capnographic monitoring during Colonoscopy - Data made available to study staff throughout procedure~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
96105|NCT01994785|O2|Outcome|EGD Capnography Blinded|"Capnographic monitoring during EGD - Data made available to study staff only if necessary for safety reasons~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
96106|NCT01994785|O1|Outcome|EGD Capnography Open|"Capnographic monitoring during EGD - Data made available to study staff throughout procedure~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
96107|NCT01994785|E4|Reported Event|Colonoscopy Capnography Blinded|"Capnographic monitoring during Colonoscopy - Data made available to study staff only if necessary for safety reasons~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
96108|NCT01994785|E3|Reported Event|Colonoscopy Capnography Open|"Capnographic monitoring during Colonoscopy - Data made available to study staff throughout procedure~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
96109|NCT01994785|E2|Reported Event|EGD Capnography Blinded|"Capnographic monitoring during EGD - Data made available to study staff only if necessary for safety reasons~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
96110|NCT01994785|E1|Reported Event|EGD Capnography Open|"Capnographic monitoring during EGD - Data made available to study staff throughout procedure~Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
96111|NCT01994746|B1|Baseline|All Study Participants|"At one visit, a glucagon dose of 3 mg (equivalent to 30 mg of AMG 504-1 dry powder) will be administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.~At another visit, 1 mg of commercially available recombinant human glucagon United States Pharmacopeia (USP) will be constituted in the provided prefilled disposable syringe containing 1 mL of diluting solution for injection into the deltoid muscle of the non-dominant arm.~The order of the visits was randomized."
96112|NCT01994746|P2|Participant Flow|Intramuscular Glucagon 1st/Intranasal Glucagon 2nd|"At the first visit, 1 mg of commercially available recombinant human glucagon United States Pharmacopeia (USP) will be constituted in the provided prefilled disposable syringe containing 1 mL of diluting solution for injection into the deltoid muscle of the non-dominant arm.~At the second visit, a glucagon dose of 3 mg (equivalent to 30 mg of AMG 504-1 dry powder) will be administered in a nostril with a prefilled delivery device that delivers a single dose upon activation."
96113|NCT01994746|P1|Participant Flow|Intranasal Glucagon 1st/Intramuscular Glucagon 2nd|"At the first visit, a glucagon dose of 3 mg (equivalent to 30 mg of AMG 504-1 dry powder) will be administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.~At the second visit, 1 mg of commercially available recombinant human glucagon United States Pharmacopeia (USP) will be constituted in the provided prefilled disposable syringe containing 1 mL of diluting solution for injection into the deltoid muscle of the non-dominant arm."
96114|NCT01994746|O2|Outcome|Intramuscular Glucagon|"At a separate visit, 1 mg of commercially available recombinant human glucagon United States Pharmacopeia (USP) will be constituted in the provided prefilled disposable syringe containing 1 mL of diluting solution for injection into the deltoid muscle of the non-dominant arm.~Intramuscular Glucagon"
96115|NCT01994746|O1|Outcome|Intranasal Glucagon|"At one visit, a glucagon dose of 3 mg (equivalent to 30 mg of AMG 504-1 dry powder) will be administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.~Intranasal Glucagon"
96116|NCT01994746|E2|Reported Event|Intramuscular Glucagon|1 mg of commercially available recombinant human glucagon United States Pharmacopeia (USP) will be constituted in the provided prefilled disposable syringe containing 1 mL of diluting solution for injection into the deltoid muscle of the non-dominant arm.
96117|NCT01994746|E1|Reported Event|Intranasal Glucagon|A glucagon dose of 3 mg (equivalent to 30 mg of AMG 504-1 dry powder) will be administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
96118|NCT01994720|B3|Baseline|Total|Total of all reporting groups
96119|NCT01994720|B2|Baseline|ASA 100 mg|ASA 100 mg once daily (OD)
96120|NCT01994720|B1|Baseline|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
96121|NCT01994720|P2|Participant Flow|ASA 100 mg|ASA 100 mg once daily (OD)
96122|NCT01994720|P1|Participant Flow|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
96123|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
96124|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
96125|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
96126|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
96127|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
96128|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
96129|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
96130|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
96131|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
96132|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
96133|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
96134|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
96135|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
96136|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
96137|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
96138|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
96139|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
96140|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
96141|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
96142|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
96143|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
96144|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
96145|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
96146|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
96147|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
96148|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
96149|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
96150|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
96151|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
96152|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
96153|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
96154|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
96155|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
96156|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
96157|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
96158|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
96159|NCT01994720|E2|Reported Event|Ticagrelor 90mg|Ticagrelor 90 mg twice daily (BD)
96160|NCT01994720|E1|Reported Event|ASA 100mg|ASA 100 mg once daily (OD)
96161|NCT01994629|B3|Baseline|Total|Total of all reporting groups
96162|NCT01994629|B2|Baseline|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
96163|NCT01994629|B1|Baseline|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
96164|NCT01994629|P2|Participant Flow|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-tetanus toxoid (TT) vaccine.
96165|NCT01994629|P1|Participant Flow|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-cross reactive material (CRM) vaccine.
96166|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
96167|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
96168|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
96169|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
96170|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
96171|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
96172|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
96173|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
96174|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
96175|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
96176|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
96177|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
96178|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
96179|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
96188|NCT01994486|B1|Baseline|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.~Telaprevir and Sofosbuvir: All subjects will have an ECG performed. Then they will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. In addition, PK samples will be collected at week 2 and week 10."
96189|NCT01994486|P1|Participant Flow|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir 1125 mg capsule twice a day with Sofosbuvir 400 mg capsule once daily for 12 weeks.~In addition, sparse PK samples will be collected at week 2 and week 10."
96190|NCT01994486|O1|Outcome|Telaprevir and Sofosbuvir|All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily for 12 weeks.
96191|NCT01994486|O1|Outcome|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir 1125 mg capsule twice a day with Sofosbuvir 400 mg capsule once daily for 12 weeks.~In addition, sparse PK samples will be collected at week 2 and week 10."
96192|NCT01994486|O1|Outcome|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.~Telaprevir and Sofosbuvir: All subjects will have an ECG performed. Then they will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. In addition, PK samples will be collected at week 2 and week 10."
96193|NCT01994486|O1|Outcome|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.~Telaprevir and Sofosbuvir: All subjects will have an ECG performed. Then they will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. In addition, PK samples will be collected at week 2 and week 10."
96194|NCT01994486|O1|Outcome|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.~Telaprevir and Sofosbuvir: All subjects will have an ECG performed. Then they will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. In addition, PK samples will be collected at week 2 and week 10."
96195|NCT01994486|O1|Outcome|Telaprevir and Sofosbuvir|All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily for 12 weeks.
96196|NCT01994486|E1|Reported Event|Telaprevir and Sofosbuvir|All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily for 12 weeks.
96197|NCT01994395|B3|Baseline|Total|Total of all reporting groups
96198|NCT01994395|B2|Baseline|Impairment Based Therapy|"Impairment based therapy will include traditional functional mobility training physical therapy.~Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training"
96199|NCT01994395|B1|Baseline|Stride Management Assist (SMA) System|"Participants will be randomized into either the SMA group or impairment based (IPT) group.~The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device."
96200|NCT01994395|P2|Participant Flow|Impairment Based Therapy|"Impairment based therapy will include traditional functional mobility training physical therapy.~Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training"
96201|NCT01994395|P1|Participant Flow|Stride Management Assist (SMA) System|"Participants will be randomized into either the SMA group or impairment based (IPT) group.~The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device."
96202|NCT01994395|O2|Outcome|Impairment Based Therapy|"Impairment based therapy will include traditional functional mobility training physical therapy.~Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training"
96203|NCT01994395|O1|Outcome|Stride Management Assist (SMA) System|"Participants will be randomized into either the SMA group or impairment based (IPT) group.~The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device."
96204|NCT01994395|O2|Outcome|Impairment Based Therapy|"Impairment based therapy will include traditional functional mobility training physical therapy.~Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training"
96205|NCT01994395|O1|Outcome|Stride Management Assist (SMA) System|"Participants will be randomized into either the SMA group or impairment based (IPT) group.~The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device."
96262|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
96263|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
96206|NCT01994395|O2|Outcome|Impairment Based Therapy|"Impairment based therapy will include traditional functional mobility training physical therapy.~Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training"
96207|NCT01994395|O1|Outcome|Stride Management Assist (SMA) System|"Participants will be randomized into either the SMA group or impairment based (IPT) group.~The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device."
96208|NCT01994395|O2|Outcome|Impairment Based Therapy|"Impairment based therapy will include traditional functional mobility training physical therapy.~Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training"
96209|NCT01994395|O1|Outcome|Stride Management Assist (SMA) System|"Participants will be randomized into either the SMA group or impairment based (IPT) group.~The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device."
96210|NCT01994395|O2|Outcome|Impairment Based Therapy|"Impairment based therapy will include traditional functional mobility training physical therapy.~Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training"
96211|NCT01994395|O1|Outcome|Stride Management Assist (SMA) System|"Participants will be randomized into either the SMA group or impairment based (IPT) group.~The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device."
96212|NCT01994395|O2|Outcome|Impairment Based Therapy|"Impairment based therapy will include traditional functional mobility training physical therapy.~Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training"
96213|NCT01994395|O1|Outcome|Stride Management Assist (SMA) System|"Participants will be randomized into either the SMA group or impairment based (IPT) group.~The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device."
96214|NCT01994395|O2|Outcome|Impairment Based Therapy|"Impairment based therapy will include traditional functional mobility training physical therapy.~Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training"
96215|NCT01994395|O1|Outcome|Stride Management Assist (SMA) System|"Participants will be randomized into either the SMA group or impairment based (IPT) group.~The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device."
96216|NCT01994395|O2|Outcome|Impairment Based Therapy|"Impairment based therapy will include traditional functional mobility training physical therapy.~Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training"
96217|NCT01994395|O1|Outcome|Stride Management Assist (SMA) System|"Participants will be randomized into either the SMA group or impairment based (IPT) group.~The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device."
96218|NCT01994395|O2|Outcome|Impairment Based Therapy|"Impairment based therapy will include traditional functional mobility training physical therapy.~Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training"
96219|NCT01994395|O1|Outcome|Stride Management Assist (SMA) System|"Participants will be randomized into either the SMA group or impairment based (IPT) group.~The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device."
96264|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
97889|NCT01986361|O2|Outcome|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
96220|NCT01994395|E2|Reported Event|Impairment Based Therapy|"Impairment based therapy will include traditional functional mobility training physical therapy.~Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training"
96221|NCT01994395|E1|Reported Event|Stride Management Assist (SMA) System|"Participants will be randomized into either the SMA group or impairment based (IPT) group.~The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device."
96222|NCT01994291|B4|Baseline|Total|Total of all reporting groups
96223|NCT01994291|B3|Baseline|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
96224|NCT01994291|B2|Baseline|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
96225|NCT01994291|B1|Baseline|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
96226|NCT01994291|P3|Participant Flow|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
96227|NCT01994291|P2|Participant Flow|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
96228|NCT01994291|P1|Participant Flow|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
96229|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
96230|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
96231|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
96232|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
96233|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
96234|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
96235|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
96236|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
96237|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
96238|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
96239|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
96240|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
96241|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
96242|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
96243|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
96244|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
96245|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
96246|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
96247|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
96248|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
96249|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
96250|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
96251|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
96252|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
96253|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
96254|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
96255|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
96256|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
96257|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
96258|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
96259|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
96260|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
96261|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
96265|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
96266|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
96267|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
96268|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
96269|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
96270|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
96271|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
96272|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
96273|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
96274|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
96275|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
96276|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
96277|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
96278|NCT01994291|E3|Reported Event|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
96279|NCT01994291|E2|Reported Event|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
96280|NCT01994291|E1|Reported Event|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
96281|NCT01994226|B3|Baseline|Total|Total of all reporting groups
96282|NCT01994226|B2|Baseline|Naproxen|"Single initial dose of 750 mg followed by 250 mg every eight hours for up to seven days~Naproxen 750 mg/250 mg: Route of Administration: Tablet – Oral Use~Dose: Single initial dose of 750 mg (three tablets) followed by 250 mg (one tablet) every eight hours for up to seven days"
96283|NCT01994226|B1|Baseline|Low-dose Colchicine|"500 mcg every eight hours for four days~Low-dose colchicine: Route of Administration: Tablet – Oral Use~Dose: 500 mcg (one tablet) every eight hours for four days"
96284|NCT01994226|P2|Participant Flow|Naproxen|"Single initial dose of 750 mg followed by 250 mg every eight hours for up to seven days~Naproxen 750 mg/250 mg: Route of Administration: Tablet – Oral Use~Dose: Single initial dose of 750 mg (three tablets) followed by 250 mg (one tablet) every eight hours for up to seven days"
96285|NCT01994226|P1|Participant Flow|Low-dose Colchicine|"500 mcg every eight hours for four days~Low-dose colchicine: Route of Administration: Tablet – Oral Use~Dose: 500 mcg (one tablet) every eight hours for four days"
96286|NCT01994226|O2|Outcome|Naproxen|"Single initial dose of 750 mg followed by 250 mg every eight hours for up to seven days~Naproxen 750 mg/250 mg: Route of Administration: Tablet – Oral Use~Dose: Single initial dose of 750 mg (three tablets) followed by 250 mg (one tablet) every eight hours for up to seven days"
96287|NCT01994226|O1|Outcome|Low-dose Colchicine|"500 mcg every eight hours for four days~Low-dose colchicine: Route of Administration: Tablet – Oral Use~Dose: 500 mcg (one tablet) every eight hours for four days"
96288|NCT01994226|E2|Reported Event|Naproxen|"Single initial dose of 750 mg followed by 250 mg every eight hours for up to seven days~Naproxen 750 mg/250 mg: Route of Administration: Tablet – Oral Use~Dose: Single initial dose of 750 mg (three tablets) followed by 250 mg (one tablet) every eight hours for up to seven days"
96289|NCT01994226|E1|Reported Event|Low-dose Colchicine|"500 mcg every eight hours for four days~Low-dose colchicine: Route of Administration: Tablet – Oral Use~Dose: 500 mcg (one tablet) every eight hours for four days"
96290|NCT01993940|B3|Baseline|Total|Total of all reporting groups
96291|NCT01993940|B2|Baseline|Placebo|Participants received placebo orally once daily for 12 weeks.
96292|NCT01993940|B1|Baseline|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
96293|NCT01993940|P2|Participant Flow|Placebo|Participants received placebo orally once daily for 12 weeks.
96294|NCT01993940|P1|Participant Flow|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
96295|NCT01993940|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
96296|NCT01993940|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
96297|NCT01993940|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
96298|NCT01993940|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
96299|NCT01993940|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
96300|NCT01993940|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
96301|NCT01993940|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
96302|NCT01993940|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
96303|NCT01993940|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
96304|NCT01993940|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
96305|NCT01993940|E2|Reported Event|Placebo|Participants received placebo orally once daily for 12 weeks.
96306|NCT01993940|E1|Reported Event|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
96307|NCT01993888|B3|Baseline|Total|Total of all reporting groups
96332|NCT01993823|O1|Outcome|G238|"Five drops into the ear canal twice daily for 14 days~G238: Five drops into the ear canal twice daily for 14 days"
96333|NCT01993823|O2|Outcome|Clotrimazole|"Five drops into the ear canal twice daily for 14 days~Clotrimazole: Five drops into the ear canal twice daily for 14 days"
96308|NCT01993888|B2|Baseline|Standard of Care (SoC)|"SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).~Standard of Care (SoC)"
96309|NCT01993888|B1|Baseline|EVARREST Fibrin Sealant Patch|"EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).~EVARREST™ Fibrin Sealant Patch"
96310|NCT01993888|P2|Participant Flow|Standard of Care (SoC)|"SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).~Standard of Care (SoC)"
96311|NCT01993888|P1|Participant Flow|EVARREST Fibrin Sealant Patch|"EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).~EVARREST™ Fibrin Sealant Patch"
96312|NCT01993888|O2|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
96313|NCT01993888|O1|Outcome|EVARREST™ Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
96314|NCT01993888|O2|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
96315|NCT01993888|O1|Outcome|EVARREST™ Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
96316|NCT01993888|O2|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
96317|NCT01993888|O1|Outcome|EVARREST™ Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
96318|NCT01993888|O2|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
96319|NCT01993888|O1|Outcome|EVARREST™ Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
96320|NCT01993888|O2|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
96321|NCT01993888|O1|Outcome|EVARREST™ Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
96322|NCT01993888|O2|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
96323|NCT01993888|O1|Outcome|EVARREST™ Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
96324|NCT01993888|E2|Reported Event|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
96325|NCT01993888|E1|Reported Event|EVARREST Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
96326|NCT01993823|B3|Baseline|Total|Total of all reporting groups
96327|NCT01993823|B2|Baseline|Clotrimazole|"Five drops into the ear canal twice daily for 14 days~Clotrimazole: Five drops into the ear canal twice daily for 14 days"
96328|NCT01993823|B1|Baseline|G238|"Five drops into the ear canal twice daily for 14 days~G238: Five drops into the ear canal twice daily for 14 days"
96329|NCT01993823|P2|Participant Flow|Clotrimazole|"Five drops into the ear canal twice daily for 14 days~Clotrimazole: Five drops into the ear canal twice daily for 14 days"
96330|NCT01993823|P1|Participant Flow|G238|"Five drops into the ear canal twice daily for 14 days~G238: Five drops into the ear canal twice daily for 14 days"
96331|NCT01993823|O2|Outcome|Clotrimazole|"Five drops into the ear canal twice daily for 14 days~Clotrimazole: Five drops into the ear canal twice daily for 14 days"
96334|NCT01993823|O1|Outcome|G238|"Five drops into the ear canal twice daily for 14 days~G238: Five drops into the ear canal twice daily for 14 days"
96335|NCT01993823|E2|Reported Event|Clotrimazole|"Five drops into the ear canal twice daily for 14 days~Clotrimazole: Five drops into the ear canal twice daily for 14 days"
96336|NCT01993823|E1|Reported Event|G238|"Five drops into the ear canal twice daily for 14 days~G238: Five drops into the ear canal twice daily for 14 days"
96337|NCT01993238|B1|Baseline|Liposonix With Pre-treatment Analgesia|"Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)~Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).~Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)"
96338|NCT01993238|P1|Participant Flow|Liposonix With Pre-treatment Analgesia|"Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)~Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).~Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)"
96339|NCT01993238|O1|Outcome|Liposonix With Pre-treatment Analgesia|"Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)~Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).~Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)"
96340|NCT01993238|O1|Outcome|Liposonix With Pre-treatment Analgesia|"Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)~Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).~Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)"
96341|NCT01993238|E1|Reported Event|Liposonix With Pre-treatment Analgesia|"Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)~Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).~Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)"
96342|NCT01993030|B3|Baseline|Total|Total of all reporting groups
96343|NCT01993030|B2|Baseline|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
96344|NCT01993030|B1|Baseline|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
96345|NCT01993030|P2|Participant Flow|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
96346|NCT01993030|P1|Participant Flow|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
96347|NCT01993030|O2|Outcome|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
96348|NCT01993030|O1|Outcome|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
96349|NCT01993030|O2|Outcome|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
96350|NCT01993030|O1|Outcome|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
96351|NCT01993030|O2|Outcome|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
96352|NCT01993030|O1|Outcome|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
96353|NCT01993030|O2|Outcome|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
96354|NCT01993030|O1|Outcome|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
96355|NCT01993030|O2|Outcome|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
96356|NCT01993030|O1|Outcome|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
96357|NCT01993030|E2|Reported Event|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
96358|NCT01993030|E1|Reported Event|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
96359|NCT01992874|B1|Baseline|Entire Study Population|It included all the subjects randomized to receive either Pimasertib 60 mg capsule and Pimasertib 60 mg tablet first in Part A and Pimasertib 60 mg capsule in Part B of the study.
96360|NCT01992874|P3|Participant Flow|Part B:Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
96361|NCT01992874|P2|Participant Flow|Part A: Pimasertib Tablet Then Pimasertib Capsule|A single dose of 3 Pimasertib 20 mg tablet administered orally on Day 1 in first intervention period followed by a single dose of 2 Pimasertib 30 mg capsule single dose administered orally on Day 3, of Part A of the study. A washout period of 48 hours was maintained between the administration of the two treatments.
96397|NCT01992536|B3|Baseline|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
96362|NCT01992874|P1|Participant Flow|Part A: Pimasertib Capsule Then Pimasertib Tablet|A single dose of 2 Pimasertib 30 mg capsule administered orally on Day 1 in first intervention period followed by a single dose of 3 Pimasertib 20 mg tablet single dose administered orally on Day 3, of Part A of the study. A washout period of 48 hours was maintained between the administration of the two treatments.
96363|NCT01992874|O1|Outcome|Part B: Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
96364|NCT01992874|O1|Outcome|Part B: Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
96365|NCT01992874|O1|Outcome|Part B: Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
96366|NCT01992874|O1|Outcome|Part B: Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
96367|NCT01992874|O3|Outcome|Part B: Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
96368|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
96369|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
96370|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
96371|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
96372|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
96373|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
96374|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
96375|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
96376|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
96377|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
96378|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
96379|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
96380|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
96381|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
96382|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
96383|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study
96384|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
96385|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
96386|NCT01992874|E3|Reported Event|Part B: Pimasertib Capsule (BID)|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
96387|NCT01992874|E2|Reported Event|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
96388|NCT01992874|E1|Reported Event|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
96389|NCT01992536|B11|Baseline|Total|Total of all reporting groups
96390|NCT01992536|B10|Baseline|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
96391|NCT01992536|B9|Baseline|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
96392|NCT01992536|B8|Baseline|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
96393|NCT01992536|B7|Baseline|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
96394|NCT01992536|B6|Baseline|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
96395|NCT01992536|B5|Baseline|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
96396|NCT01992536|B4|Baseline|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
96600|NCT01992536|O4|Outcome|Menveo|Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
96398|NCT01992536|B2|Baseline|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
96399|NCT01992536|B1|Baseline|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
96400|NCT01992536|P10|Participant Flow|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
96401|NCT01992536|P9|Participant Flow|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
96402|NCT01992536|P8|Participant Flow|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
96403|NCT01992536|P7|Participant Flow|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
96404|NCT01992536|P6|Participant Flow|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
96405|NCT01992536|P5|Participant Flow|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
96406|NCT01992536|P4|Participant Flow|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
96407|NCT01992536|P3|Participant Flow|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
96408|NCT01992536|P2|Participant Flow|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
96409|NCT01992536|P1|Participant Flow|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
96410|NCT01992536|O10|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
96411|NCT01992536|O9|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
96412|NCT01992536|O8|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
96413|NCT01992536|O7|Outcome|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
96414|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
96415|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
96416|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
96417|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
96418|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
96419|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
96420|NCT01992536|O10|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
96421|NCT01992536|O9|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
96422|NCT01992536|O8|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
96423|NCT01992536|O7|Outcome|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
96424|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
96425|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
96426|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
96427|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
96428|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
96429|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
96430|NCT01992536|O10|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
96431|NCT01992536|O9|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
96432|NCT01992536|O8|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
96433|NCT01992536|O7|Outcome|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
96434|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
96435|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
96436|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
96437|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
96438|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
96439|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
96440|NCT01992536|O11|Outcome|Total|
96441|NCT01992536|O10|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
96442|NCT01992536|O9|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
96443|NCT01992536|O8|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
96444|NCT01992536|O7|Outcome|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
96445|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
96446|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
96447|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
96448|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
96449|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
96450|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
96451|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
96452|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
96453|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
96454|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
96455|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
96456|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
96457|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
96458|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
96459|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
96460|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
96461|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
96462|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
96463|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
96464|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
96465|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
96466|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
96467|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
96468|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
96469|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
96470|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
96471|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
96472|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
96473|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
96474|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
96475|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
96476|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
96477|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
96601|NCT01992536|O3|Outcome|rMenB+OMV|Subjects received two doses of rMenB + OMV, administered two months apart.
96478|NCT01992536|O6|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
96479|NCT01992536|O5|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
96480|NCT01992536|O4|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
96481|NCT01992536|O3|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
96482|NCT01992536|O2|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
96483|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
96484|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
96485|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
96486|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
96487|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
96488|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
96489|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
96490|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
96491|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
96492|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
96493|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
96494|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
96495|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
96496|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
96497|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
96498|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
96499|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
96500|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
96501|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
96502|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
96503|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
96504|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
96505|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
96506|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
96507|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
96508|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
96509|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
96510|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
96511|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
96512|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
96513|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
96514|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
96515|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
96516|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
96517|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
96518|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
96519|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
96520|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
96521|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
96522|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
96523|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
96524|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
96525|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
96526|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
96527|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
96528|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
96529|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
96530|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
96531|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
96532|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
96533|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
96534|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
96535|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
96536|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
96537|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
96538|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
96539|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
96540|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
96541|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
96542|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
96543|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
96544|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
96545|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
96546|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
96547|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
96548|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
96549|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
96550|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
96551|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
96552|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
96553|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
96554|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
96555|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
96556|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
96557|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
96558|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
96559|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
96560|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
96561|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
96562|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
96563|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
96564|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
96565|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
96566|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
96567|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
96568|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
96569|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
96570|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
96571|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
96572|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
96573|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
96574|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
96575|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
96576|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
96577|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
96578|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
96579|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
96580|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
96581|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
96582|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
96583|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
96584|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
96585|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
96586|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
96587|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
96588|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
96589|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
96590|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
96591|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
96592|NCT01992536|O4|Outcome|Menveo|Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
96593|NCT01992536|O3|Outcome|rMenB+OMV|Subjects received two doses of rMenB + OMV, administered two months apart.
96594|NCT01992536|O2|Outcome|ABCWY+qOMV|Subjects received two doses of MenABCWY + qOMV administered two months apart.
96595|NCT01992536|O1|Outcome|ABCWY+OMV|Subjects received two doses of MenABCWY + OMV administered two months apart.
96596|NCT01992536|O4|Outcome|Menveo|Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
96597|NCT01992536|O3|Outcome|rMenB+OMV|Subjects received two doses of rMenB + OMV, administered two months apart.
96598|NCT01992536|O2|Outcome|ABCWY+qOMV|Subjects received two doses of MenABCWY + qOMV administered two months apart.
96599|NCT01992536|O1|Outcome|ABCWY+OMV|Subjects received two doses of MenABCWY + OMV administered two months apart.
96602|NCT01992536|O2|Outcome|ABCWY+qOMV|Subjects received two doses of MenABCWY + qOMV administered two months apart.
96603|NCT01992536|O1|Outcome|ABCWY+OMV|Subjects received two doses of MenABCWY + OMV administered two months apart.
96604|NCT01992536|O4|Outcome|Menveo|Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
96605|NCT01992536|O3|Outcome|rMenB+OMV|Subjects received two doses of rMenB + OMV, administered two months apart.
96606|NCT01992536|O2|Outcome|ABCWY+qOMV|Subjects received two doses of MenABCWY + qOMV administered two months apart.
96607|NCT01992536|O1|Outcome|ABCWY+OMV|Subjects received two doses of MenABCWY + OMV administered two months apart.
96608|NCT01992536|O2|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
96609|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
96610|NCT01992536|O2|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
96611|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
96612|NCT01992536|E11|Reported Event|Total|Total
96613|NCT01992536|E10|Reported Event|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
96614|NCT01992536|E9|Reported Event|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
96615|NCT01992536|E8|Reported Event|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
96616|NCT01992536|E7|Reported Event|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
96617|NCT01992536|E6|Reported Event|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
96618|NCT01992536|E5|Reported Event|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
96619|NCT01992536|E4|Reported Event|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
96620|NCT01992536|E3|Reported Event|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
96621|NCT01992536|E2|Reported Event|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
96622|NCT01992536|E1|Reported Event|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
96623|NCT01992523|B3|Baseline|Total|Total of all reporting groups
96624|NCT01992523|B2|Baseline|Ticagrelor Integral Pills|"Ticagrelor loading dose (LD) 180 mg as integral pills~Ticagrelor integral pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor)."
96625|NCT01992523|B1|Baseline|Ticagrelor Mashed Pills|"Ticagrelor loading dose (LD) 180 mg as mashed pills~Ticagrelor mashed pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient."
96626|NCT01992523|P2|Participant Flow|Ticagrelor Integral Pills|"Ticagrelor loading dose (LD) 180 mg as integral pills~Ticagrelor integral pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor)."
96627|NCT01992523|P1|Participant Flow|Ticagrelor Mashed Pills|"Ticagrelor loading dose (LD) 180 mg as mashed pills~Ticagrelor mashed pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient."
96628|NCT01992523|O2|Outcome|Ticagrelor Integral Pills|"Ticagrelor loading dose (LD) 180 mg as integral pills~Ticagrelor integral pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor)."
96629|NCT01992523|O1|Outcome|Ticagrelor Mashed Pills|"Ticagrelor loading dose (LD) 180 mg as mashed pills~Ticagrelor mashed pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient."
96665|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
96630|NCT01992523|O2|Outcome|Ticagrelor Integral Pills|"Ticagrelor loading dose (LD) 180 mg as integral pills~Ticagrelor integral pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor)."
96631|NCT01992523|O1|Outcome|Ticagrelor Mashed Pills|"Ticagrelor loading dose (LD) 180 mg as mashed pills~Ticagrelor mashed pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient."
96632|NCT01992523|O2|Outcome|Ticagrelor Integral Pills|"Ticagrelor loading dose (LD) 180 mg as integral pills~Ticagrelor integral pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor)."
96633|NCT01992523|O1|Outcome|Ticagrelor Mashed Pills|"Ticagrelor loading dose (LD) 180 mg as mashed pills~Ticagrelor mashed pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient."
96634|NCT01992523|O2|Outcome|Ticagrelor Integral Pills|
96635|NCT01992523|O1|Outcome|Ticagrelor Mashed Pills|
96636|NCT01992523|E2|Reported Event|Ticagrelor Integral Group|patients taking orally 180 mg ticagrelor integral tablets
96637|NCT01992523|E1|Reported Event|Ticagrelor Mashed Group|patients taking orally 180 mg ticagrelor mashed tablets
96638|NCT01992185|B3|Baseline|Total|Total of all reporting groups
96639|NCT01992185|B2|Baseline|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
96640|NCT01992185|B1|Baseline|Photocil for Vitiligo|"Active Drug - Photocil for Vitiligo~Photocil for Vitiligo: Photocil for Vitiligo"
96641|NCT01992185|P2|Participant Flow|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
96642|NCT01992185|P1|Participant Flow|Photocil for Vitiligo|"Active Drug - Photocil for Vitiligo~Photocil for Vitiligo: Photocil for Vitiligo"
96643|NCT01992185|O2|Outcome|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
96644|NCT01992185|O1|Outcome|Photocil for Vitiligo|"Active Drug - Photocil for Vitiligo~Photocil for Vitiligo: Photocil for Vitiligo"
96645|NCT01992185|E2|Reported Event|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
96646|NCT01992185|E1|Reported Event|Photocil for Vitiligo|"Active Drug - Photocil for Vitiligo~Photocil for Vitiligo: Photocil for Vitiligo"
96647|NCT01992172|B3|Baseline|Total|Total of all reporting groups
96648|NCT01992172|B2|Baseline|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
96649|NCT01992172|B1|Baseline|Photocil for Atopic Dermatitis|"Active Drug - Photocil for Atopic Dermatitis~Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis"
96650|NCT01992172|P2|Participant Flow|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
96651|NCT01992172|P1|Participant Flow|Photocil for Atopic Dermatitis|"Active Drug - Photocil for Atopic Dermatitis~Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis"
96652|NCT01992172|O2|Outcome|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
96653|NCT01992172|O1|Outcome|Photocil for Atopic Dermatitis|"Active Drug - Photocil for Atopic Dermatitis~Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis"
96654|NCT01992172|E2|Reported Event|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
96655|NCT01992172|E1|Reported Event|Photocil for Atopic Dermatitis|"Active Drug - Photocil for Atopic Dermatitis~Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis"
96656|NCT01992107|B4|Baseline|Total|Total of all reporting groups
96657|NCT01992107|B3|Baseline|TIV2c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96658|NCT01992107|B2|Baseline|TIV1c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
96659|NCT01992107|B1|Baseline|QIVc|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
96660|NCT01992107|P3|Participant Flow|TIV2c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96661|NCT01992107|P2|Participant Flow|TIV1c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
96662|NCT01992107|P1|Participant Flow|QIVc|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
96663|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96664|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
96895|NCT01990794|O3|Outcome|Study Midpoint - Right|Values of the right eye for select RNFL variables
96666|NCT01992107|O15|Outcome|TIV2c (≥9 to <18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96667|NCT01992107|O14|Outcome|TIV1c (≥9 to <18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
96668|NCT01992107|O13|Outcome|QIVc (≥9 to <18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
96669|NCT01992107|O12|Outcome|TIV2c _Second Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96670|NCT01992107|O11|Outcome|TIV1c_Second Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
96671|NCT01992107|O10|Outcome|QIVc _Second Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
96672|NCT01992107|O9|Outcome|TIV2c _First Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96673|NCT01992107|O8|Outcome|TIV1c_First Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2,B1) recommended for 2013-2014 season
96674|NCT01992107|O7|Outcome|QIVc _First Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
96675|NCT01992107|O6|Outcome|TIV2c _Second Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96676|NCT01992107|O5|Outcome|TIV1c_Second Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
96677|NCT01992107|O4|Outcome|QIVc _Second Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
96678|NCT01992107|O3|Outcome|TIV2c _First Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96679|NCT01992107|O2|Outcome|TIV1c_First Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
96680|NCT01992107|O1|Outcome|QIVc _First Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
96681|NCT01992107|O2|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96682|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
96683|NCT01992107|O2|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96684|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
96685|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
96686|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
96687|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
96688|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
96689|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96690|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
96691|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
96692|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96693|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
96694|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
96695|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96696|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
96697|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
96698|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96699|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
96700|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
96701|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96702|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
96703|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
96704|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96705|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
96706|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
96707|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96708|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
96709|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
96710|NCT01992107|E4|Reported Event|Total|Total number of Subjects
96711|NCT01992107|E3|Reported Event|TIV2c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96712|NCT01992107|E2|Reported Event|TIV1c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
96713|NCT01992107|E1|Reported Event|QIVc|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
96714|NCT01992094|B4|Baseline|Total|Total of all reporting groups
96715|NCT01992094|B3|Baseline|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96716|NCT01992094|B2|Baseline|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season
96717|NCT01992094|B1|Baseline|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
96718|NCT01992094|P3|Participant Flow|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96719|NCT01992094|P2|Participant Flow|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season
96720|NCT01992094|P1|Participant Flow|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
96721|NCT01992094|O3|Outcome|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96722|NCT01992094|O2|Outcome|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
96723|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
96724|NCT01992094|O3|Outcome|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96725|NCT01992094|O2|Outcome|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
96726|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
96727|NCT01992094|O2|Outcome|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96728|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
96729|NCT01992094|O2|Outcome|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96730|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
96731|NCT01992094|O2|Outcome|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
96732|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
96733|NCT01992094|O2|Outcome|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
96734|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
96735|NCT01992094|O6|Outcome|TIV2c (≥ 61 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96736|NCT01992094|O5|Outcome|TIV2c (18 to ≤60 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96737|NCT01992094|O4|Outcome|TIV1c (≥ 61 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
96738|NCT01992094|O3|Outcome|TIV1c (18 to ≤60 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
96739|NCT01992094|O2|Outcome|QIVc (≥ 61 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
96740|NCT01992094|O1|Outcome|QIVc (18 to ≤60 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
96741|NCT01992094|O6|Outcome|TIV2c (≥ 61 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96742|NCT01992094|O5|Outcome|TIV2c (18 to ≤60 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96743|NCT01992094|O4|Outcome|TIV1c (≥ 61 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
96744|NCT01992094|O3|Outcome|TIV1c (18 to ≤60 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
96745|NCT01992094|O2|Outcome|QIVc (≥ 61 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
96746|NCT01992094|O1|Outcome|QIVc (18 to ≤60 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
96747|NCT01992094|O6|Outcome|TIV2c (≥ 61 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96748|NCT01992094|O5|Outcome|TIV2c (18 to ≤60 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96749|NCT01992094|O4|Outcome|TIV1c (≥ 61 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
96750|NCT01992094|O3|Outcome|TIV1c (18 to ≤60 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
96751|NCT01992094|O2|Outcome|QIVc (≥ 61 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
96752|NCT01992094|O1|Outcome|QIVc (18 to ≤60 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
96753|NCT01992094|O6|Outcome|TIV2c (≥ 65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96754|NCT01992094|O5|Outcome|TIV2c (18 to <65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96755|NCT01992094|O4|Outcome|TIV1c (≥ 65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season
96756|NCT01992094|O3|Outcome|TIV1c (18 to <65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season
96757|NCT01992094|O2|Outcome|QIVc (≥ 65 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
96758|NCT01992094|O1|Outcome|QIVc (18 to <65 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
96759|NCT01992094|O6|Outcome|TIV2c (≥ 65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96760|NCT01992094|O5|Outcome|TIV2c (18 to <65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96761|NCT01992094|O4|Outcome|TIV1c (≥ 65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1)recommended for 2013-2014 season
96762|NCT01992094|O3|Outcome|TIV1c (18 to <65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013- 2014 season
96763|NCT01992094|O2|Outcome|QIVc (≥ 65 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
96764|NCT01992094|O1|Outcome|QIVc (18 to <65 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
96765|NCT01992094|O3|Outcome|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96766|NCT01992094|O2|Outcome|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
96767|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
96768|NCT01992094|O3|Outcome|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96769|NCT01992094|O2|Outcome|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
96770|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
96771|NCT01992094|E4|Reported Event|Total|Total Number of Subjects
96772|NCT01992094|E3|Reported Event|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
96773|NCT01992094|E2|Reported Event|TIV1c (≥ 18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
96774|NCT01992094|E1|Reported Event|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
96775|NCT01991990|B3|Baseline|Total|Total of all reporting groups
96776|NCT01991990|B2|Baseline|Tocilizumab|Participants received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0.
96777|NCT01991990|B1|Baseline|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
96778|NCT01991990|P2|Participant Flow|Tocilizumab|Participants received a single dose of intravenous (IV) tocilizumab (TCZ) at a dose of 8 milligrams (mg) per kilogram (kg) body weight infusion over 1 hour on Day 0.
96779|NCT01991990|P1|Participant Flow|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
96780|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
96896|NCT01990794|O2|Outcome|Prestudy - Left|Values of the left eye for select RNFL variables
96781|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
96782|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
96783|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
96784|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
96785|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
96786|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
96787|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
96788|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
96789|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
96790|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
96791|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
96792|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
96793|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
96794|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
96795|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
96796|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
96797|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
96798|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
96799|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
96800|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
96801|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
96802|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
96803|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
96804|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
96805|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
96806|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
96807|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
96808|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and with ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
96809|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
96810|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
96811|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
96812|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
96897|NCT01990794|O1|Outcome|Prestudy - Right|Values of the right eye for select RNFL variables
96813|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and with greater than (>) 50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
96814|NCT01991990|O2|Outcome|Tocilizumab (Polymorphonuclear Leukocyte (PMN)]-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and with less than or equal to (≤) 50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
96815|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
96816|NCT01991990|E2|Reported Event|Tocilizumab|Participants received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0.
96817|NCT01991990|E1|Reported Event|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
96818|NCT01991548|B1|Baseline|Insulin Dependent Diabetics|individuals with insulin dependant diabetes using the 640G insulin pump for insulin infusion and continuous glucose monitoring
96819|NCT01991548|P1|Participant Flow|Insulin Dependent Diabetics|Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 640G insulin pump and Guardian Link transmitter.
96820|NCT01991548|O1|Outcome|Overall|Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess overall subject acceptance of the MiniMed 640G and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance.
96821|NCT01991548|E1|Reported Event|Overall|Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess overall subject acceptance of the MiniMed 640G and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance.
96822|NCT01991314|B3|Baseline|Total|Total of all reporting groups
96823|NCT01991314|B2|Baseline|Adults - Ferrous Sulphate|43 adults (age >18 years) given oral ferrous sulphate 200mg bd for 6 weeks
96824|NCT01991314|B1|Baseline|Adolescent - Ferrous Sulphate|45 adolescents (age 13-18 years) given oral ferrous sulphate 200mg bd for 6 weeks
96825|NCT01991314|P2|Participant Flow|Adults - Ferrous Sulphate|43 adults (>18 years) given ferrous sulphate 200mg bd for 6 weeks
96826|NCT01991314|P1|Participant Flow|Adolescents - Ferrous Sulphate|45 adolescents (13-18 years) given ferrous sulphate 200mg bd for 6 weeks
96827|NCT01991314|O2|Outcome|Adults|IBD patients aged >18
96828|NCT01991314|O1|Outcome|Adolescents|Patients aged 13 - 18 years
96829|NCT01991314|O2|Outcome|Adults|IBD patients aged >18
96830|NCT01991314|O1|Outcome|Adolescents|Patients aged 13 - 18 years
96831|NCT01991314|O2|Outcome|Adults|IBD patients aged >18
96832|NCT01991314|O1|Outcome|Adolescents|Patients aged 13 - 18 years
96833|NCT01991314|O2|Outcome|Adults|IBD patients aged >18
96834|NCT01991314|O1|Outcome|Adolescents|Patients aged 13 - 18 years
96835|NCT01991314|O2|Outcome|Adults|IBD patients aged >18
96836|NCT01991314|O1|Outcome|Adolescents|Patients aged 13 - 18 years
96837|NCT01991314|O2|Outcome|Adults|IBD patients aged >18
96838|NCT01991314|O1|Outcome|Adolescents|Patients aged 13 - 18 years
96839|NCT01991314|O2|Outcome|Adults|IBD patients aged >18
96840|NCT01991314|O1|Outcome|Adolescents|Patients aged 13 - 18 years
96841|NCT01991314|E2|Reported Event|Adults|IBD patients aged >18
96842|NCT01991314|E1|Reported Event|Adolescents|Patients aged 13 - 18 years
96843|NCT01990898|B1|Baseline|Treatment|Cyclosporine
96844|NCT01990898|P1|Participant Flow|Treatment|Cyclosporine
96845|NCT01990898|O1|Outcome|Treatment|Cyclosporine
96846|NCT01990898|E1|Reported Event|Treatment|Cyclosporine
96847|NCT01990859|B1|Baseline|Ipilimumab|Participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses.
96848|NCT01990859|P1|Participant Flow|Ipilimumab|During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
96849|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
96850|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
96851|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
96852|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
96898|NCT01990794|O3|Outcome|Study Completion|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
96853|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
96854|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
96855|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
96856|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
96857|NCT01990859|E1|Reported Event|Ipilimumab|During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
96858|NCT01990794|B1|Baseline|Study Volunteers|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
96859|NCT01990794|P1|Participant Flow|Study Volunteers|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
96860|NCT01990794|O4|Outcome|1 mo Postdose|Values of the sural sensory and peroneal motor variables
96861|NCT01990794|O3|Outcome|Study Completion|Values of the sural sensory and peroneal motor variables
96862|NCT01990794|O2|Outcome|Study Midpoint|Values of the sural sensory and peroneal motor variables
96863|NCT01990794|O1|Outcome|Prestudy|Values of the sural sensory and peroneal motor variables
96864|NCT01990794|O4|Outcome|1 mo Postdose|Values of the sural sensory and peroneal motor variables
96865|NCT01990794|O3|Outcome|Study Completion|Values of the sural sensory and peroneal motor variables
96866|NCT01990794|O2|Outcome|Study Midpoint|Values of the sural sensory and peroneal motor variables
96867|NCT01990794|O1|Outcome|Prestudy|Values of the sural sensory and peroneal motor variables
96868|NCT01990794|O6|Outcome|Study Completion - Left|Values of the left eye for select VFI variables
96869|NCT01990794|O5|Outcome|Study Completion - Right|Values of the right eye for select VFI variables
96870|NCT01990794|O4|Outcome|Study Midpoint - Left|Values of the left eye for select VFI variables
96871|NCT01990794|O3|Outcome|Study Midpoint - Right|Values of the right eye for select VFI variables
96872|NCT01990794|O2|Outcome|Prestudy - Left|Values of the left eye for select VFI variables
96873|NCT01990794|O1|Outcome|Prestudy - Right|Values of the right eye for select VFI variables
96874|NCT01990794|O6|Outcome|Study Completion - Left|Values of the left eye for select VFI variables
96875|NCT01990794|O5|Outcome|Study Completion - Right|Values of the right eye for select VFI variables
96876|NCT01990794|O4|Outcome|Study Midpoint - Left|Values of the left eye for select VFI variables
96877|NCT01990794|O3|Outcome|Study Midpoint - Right|Values of the right eye for select VFI variables
96878|NCT01990794|O2|Outcome|Prestudy - Left|Values of the left eye for select VFI variables
96879|NCT01990794|O1|Outcome|Prestudy - Right|Values of the right eye for select VFI variables
96880|NCT01990794|O6|Outcome|Study Completion - Left|Values of the left eye for select OHN variables
96881|NCT01990794|O5|Outcome|Study Completion - Right|Values of the right eye for select OHN variables
96882|NCT01990794|O4|Outcome|Study Midpoint - Left|Values of the left eye for select OHN variables
96883|NCT01990794|O3|Outcome|Study Midpoint - Right|Values of the right eye for select OHN variables
96884|NCT01990794|O2|Outcome|Prestudy - Left|Values of the left eye for select OHN variables
96885|NCT01990794|O1|Outcome|Prestudy - Right|Values of the right eye for select OHN variables
96886|NCT01990794|O6|Outcome|Study Completion - Left|Values of the left eye for select OHN variables
96887|NCT01990794|O5|Outcome|Study Completion - Right|Values of the right eye for select OHN variables
96888|NCT01990794|O4|Outcome|Study Midpoint - Left|Values of the left eye for select OHN variables
96889|NCT01990794|O3|Outcome|Study Midpoint - Right|Values of the right eye for select OHN variables
96890|NCT01990794|O2|Outcome|Prestudy - Left|Values of the left eye for select OHN variables
96891|NCT01990794|O1|Outcome|Prestudy - Right|Values of the right eye for select OHN variables
96892|NCT01990794|O6|Outcome|Study Completion - Left|Values of the left eye for select RNFL variables
96893|NCT01990794|O5|Outcome|Study Completion - Right|Values of the right eye for select RNFL variables
96894|NCT01990794|O4|Outcome|Study Midpoint - Left|Values of the left eye for select RNFL variables
96899|NCT01990794|O2|Outcome|Study Midpoint|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
96900|NCT01990794|O1|Outcome|Prestudy|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
96901|NCT01990794|O3|Outcome|Study Completion|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
96902|NCT01990794|O2|Outcome|Study Midpoint|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
96903|NCT01990794|O1|Outcome|Prestudy|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
96904|NCT01990794|O2|Outcome|Male Cobalt Serum Concentrations|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
96905|NCT01990794|O1|Outcome|Female Cobalt Serum Concentrations|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
96906|NCT01990794|O2|Outcome|Male Cobalt Urine Concentrations|Cobalt urine concentrations after cessation of cobalt supplementation
96907|NCT01990794|O1|Outcome|Female Cobalt Urine Concentrations|Cobalt urine concentrations after cessation of cobalt supplementation
96908|NCT01990794|O2|Outcome|Male Cobalt Urine Concentrations|Cobalt urine concentrations during daily oral intake of 1 mg Co.
96909|NCT01990794|O1|Outcome|Female Cobalt Urine Concentrations|Cobalt urine concentrations during daily oral intake of 1 mg Co.
96910|NCT01990794|O2|Outcome|Male Glucose|Glucose levels before, during, and after dosing
96911|NCT01990794|O1|Outcome|Female Glucose|Glucose levels before, during and after dosing
96912|NCT01990794|O2|Outcome|Male Triglycerides|Triglyceride levels before and after cobalt supplementation
96913|NCT01990794|O1|Outcome|Female Triglycerides|Triglyceride levels before and after cobalt supplementation
96914|NCT01990794|O2|Outcome|Male Total Cholesterol|Total cholesterol levels before and after cobalt supplementation
96915|NCT01990794|O1|Outcome|Female Total Cholesterol|Total cholesterol levels before and after cobalt supplementation
96916|NCT01990794|O2|Outcome|Male HDL Cholesterol|HDL cholesterol levels before and after cobalt supplementation
96917|NCT01990794|O1|Outcome|Female HDL Cholesterol|HDL cholesterol levels before and after cobalt supplementation
96918|NCT01990794|O2|Outcome|Male AST|AST levels before, during, and after dosing
96919|NCT01990794|O1|Outcome|Female AST|AST levels before, during and after dosing
96920|NCT01990794|O2|Outcome|Male ALT|ALT levels before, during, and after dosing
96921|NCT01990794|O1|Outcome|Female ALT|ALT levels before, during and after dosing
96922|NCT01990794|O2|Outcome|Male Creatine|Creatine levels before, during, and after dosing
96923|NCT01990794|O1|Outcome|Female Creatine|Creatine levels before, during and after dosing
96924|NCT01990794|O2|Outcome|Male CK-MB|CK-MB levels before, during, and after dosing
96925|NCT01990794|O1|Outcome|Female CK-MB|CK-MB levels before, during and after dosing
96926|NCT01990794|O2|Outcome|Male Ferritin|Ferritin levels before, during, and after dosing
96927|NCT01990794|O1|Outcome|Female Ferritin|Ferritin levels before, during and after dosing
96928|NCT01990794|O2|Outcome|Male Total Iron|Total iron levels before, during, and after dosing
96929|NCT01990794|O1|Outcome|Female Total Iron|Total iron levels before, during and after dosing
96930|NCT01990794|O2|Outcome|Male T4|T4 levels before, during, and after dosing
96931|NCT01990794|O1|Outcome|Female T4|T4 levels before, during and after dosing
96932|NCT01990794|O2|Outcome|Male TSH|TSH levels before, during, and after dosing
96933|NCT01990794|O1|Outcome|Female TSH|TSH levels before, during and after dosing
96934|NCT01990794|O2|Outcome|Male Albumin|Albumin levels before, during, and after dosing
96935|NCT01990794|O1|Outcome|Female Albumin|Albumin levels before, during and after dosing
96936|NCT01990794|O2|Outcome|Male Protein|Protein levels before, during, and after dosing
96937|NCT01990794|O1|Outcome|Female Protein|Protein levels before, during and after dosing
96938|NCT01990794|O2|Outcome|Male Hematocrit|Hematocrit levels before, during, and after dosing
96939|NCT01990794|O1|Outcome|Female Hematocrit|Hematocrit levels before, during and after dosing
96940|NCT01990794|O2|Outcome|Male RBC|RBC levels before, during, and after dosing
96941|NCT01990794|O1|Outcome|Female RBC|RBC levels before, during and after dosing
96942|NCT01990794|O2|Outcome|Male WBC|WBC levels before, during, and after dosing
96943|NCT01990794|O1|Outcome|Female WBC|WBC levels before, during and after dosing
96944|NCT01990794|O2|Outcome|Male|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
96945|NCT01990794|O1|Outcome|Female|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
96946|NCT01990794|O3|Outcome|Study Completion|Values of the sural sensory and peroneal motor variables
96947|NCT01990794|O2|Outcome|Study Midpoint|Values of the sural sensory and peroneal motor variables
96948|NCT01990794|O1|Outcome|Prestudy|Values of the sural sensory and peroneal motor variables
96949|NCT01990794|O6|Outcome|Study Completion - Left|Values of the left eye for select ONH variables
96950|NCT01990794|O5|Outcome|Study Completion - Right|Values of the right eye for select ONH variables
96951|NCT01990794|O4|Outcome|Study Midpoint - Left|Values of the left eye for select ONH variables
96952|NCT01990794|O3|Outcome|Study Midpoint - Right|Values of the right eye for select ONH variables
96955|NCT01990794|O3|Outcome|Study Completion|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
96956|NCT01990794|O2|Outcome|Study Midpoint|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
96957|NCT01990794|O1|Outcome|Prestudy|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
96958|NCT01990794|O6|Outcome|Study Completion - Right|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
96959|NCT01990794|O5|Outcome|Study Completion - Left|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
96960|NCT01990794|O4|Outcome|Study Midpoint - Right|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
96961|NCT01990794|O3|Outcome|Study Midpoint - Left|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
96962|NCT01990794|O2|Outcome|Baseline - Right|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
96963|NCT01990794|O1|Outcome|Baseline - Left|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
96964|NCT01990794|O2|Outcome|Male Hgb|Hgb levels before, during, and after dosing
96965|NCT01990794|O1|Outcome|Female Hgb|Hgb levels before, during and after dosing
96966|NCT01990794|O2|Outcome|SI After Cobalt Supplementation|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT)."
96967|NCT01990794|O1|Outcome|SI Before Cobalt Supplementation|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT)."
96968|NCT01990794|O1|Outcome|Albumin-Co Fraction|Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
96969|NCT01990794|E1|Reported Event|Study Volunteers|"Study volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
96970|NCT01990703|B3|Baseline|Total|Total of all reporting groups
96971|NCT01990703|B2|Baseline|Standard Postpartum Insertion Group|"Placement of the levonorgestrel IUD 4-6 weeks postpartum~Levonorgestrel IUD: Timing of IUD insertion"
96972|NCT01990703|B1|Baseline|Early IUD Insertion Group|"Immediate post-placental placement of the levonorgestrel IUD~Levonorgestrel IUD: Timing of IUD insertion"
96973|NCT01990703|P2|Participant Flow|Standard Postpartum Insertion Group|"Placement of the levonorgestrel IUD 4-6 weeks postpartum~Levonorgestrel IUD: Timing of IUD insertion"
96974|NCT01990703|P1|Participant Flow|Early IUD Insertion Group|"Immediate post-placental placement of the levonorgestrel IUD~Levonorgestrel IUD: Timing of IUD insertion"
96975|NCT01990703|O2|Outcome|Standard Postpartum Insertion Group|"Placement of the levonorgestrel IUD 4-6 weeks postpartum~Levonorgestrel IUD: Timing of IUD insertion"
96976|NCT01990703|O1|Outcome|Early IUD Insertion Group|"Immediate post-placental placement of the levonorgestrel IUD~Levonorgestrel IUD: Timing of IUD insertion"
96977|NCT01990703|O2|Outcome|Standard Postpartum Insertion Group|"Placement of the levonorgestrel IUD 4-6 weeks postpartum~Levonorgestrel IUD: Timing of IUD insertion"
96978|NCT01990703|O1|Outcome|Early IUD Insertion Group|"Immediate post-placental placement of the levonorgestrel IUD~Levonorgestrel IUD: Timing of IUD insertion"
96979|NCT01990703|E2|Reported Event|Standard Postpartum Insertion Group|"Placement of the levonorgestrel IUD 4-6 weeks postpartum~Levonorgestrel IUD: Timing of IUD insertion"
96980|NCT01990703|E1|Reported Event|Early IUD Insertion Group|"Immediate post-placental placement of the levonorgestrel IUD~Levonorgestrel IUD: Timing of IUD insertion"
96981|NCT01990677|B3|Baseline|Total|Total of all reporting groups
96982|NCT01990677|B2|Baseline|Placebo- Chronic CSCR Diagnosis|"Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 58 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient.~Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
96983|NCT01990677|B1|Baseline|25mg Eplerenone- Chronic CSCR Diagnosis|"Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 58 days. Throughout the 58 day treatment period dosage will be adjusted. The adjustment will be based on serum potassium and creatine levels from blood draws done at Day 12 and Day 33. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.~25mg Eplerenone: Patients will be given 25mg Eplerenone (or 50mg Eplerenone) or placebo throughout the study and the dosage will be based on the serum potassium/creatine levels. Patients will be randomized 2:1 such that 36 patients in each group will receive eplerenone and 16 patients in each group will receive placebo~Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
96984|NCT01990677|P2|Participant Flow|Placebo- Chronic CSCR Diagnosis|"Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 58 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient.~Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
96998|NCT01990664|P1|Participant Flow|Control (Senfilcon A)|Subjects that were randomized to receive the Control lens for the duration of the study.
99171|NCT01978314|O1|Outcome|Cohort 1|eGFR renal function ≥60 mL/min for normal function
96985|NCT01990677|P1|Participant Flow|25mg Eplerenone- Chronic CSCR Diagnosis|"Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 58 days. Throughout the 58 day treatment period dosage will be adjusted. The adjustment will be based on serum potassium and creatine levels from blood draws done at Day 12 and Day 33. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.~25mg Eplerenone: Patients will be given 25mg Eplerenone (or 50mg Eplerenone) or placebo throughout the study and the dosage will be based on the serum potassium/creatine levels. Patients will be randomized 2:1 such that 36 patients in each group will receive eplerenone and 16 patients in each group will receive placebo~Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
96986|NCT01990677|O2|Outcome|Placebo- Chronic CSCR Diagnosis|"Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 58 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient.~Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
96987|NCT01990677|O1|Outcome|25mg Eplerenone- Chronic CSCR Diagnosis|"Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 58 days. Throughout the 58 day treatment period dosage will be adjusted. The adjustment will be based on serum potassium and creatine levels from blood draws done at Day 12 and Day 33. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.~25mg Eplerenone: Patients will be given 25mg Eplerenone (or 50mg Eplerenone) or placebo throughout the study and the dosage will be based on the serum potassium/creatine levels. Patients will be randomized 2:1 such that 36 patients in each group will receive eplerenone and 16 patients in each group will receive placebo~Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
96988|NCT01990677|O2|Outcome|Placebo- Chronic CSCR Diagnosis|"Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 58 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient.~Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
96989|NCT01990677|O1|Outcome|25mg Eplerenone- Chronic CSCR Diagnosis|"Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 58 days. Throughout the 58 day treatment period dosage will be adjusted. The adjustment will be based on serum potassium and creatine levels from blood draws done at Day 12 and Day 33. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.~25mg Eplerenone: Patients will be given 25mg Eplerenone (or 50mg Eplerenone) or placebo throughout the study and the dosage will be based on the serum potassium/creatine levels. Patients will be randomized 2:1 such that 36 patients in each group will receive eplerenone and 16 patients in each group will receive placebo~Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
96990|NCT01990677|O2|Outcome|Placebo- Chronic CSCR Diagnosis|"Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 58 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient.~Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
96991|NCT01990677|O1|Outcome|25mg Eplerenone- Chronic CSCR Diagnosis|"Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 58 days. Throughout the 58 day treatment period dosage will be adjusted. The adjustment will be based on serum potassium and creatine levels from blood draws done at Day 12 and Day 33. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.~25mg Eplerenone: Patients will be given 25mg Eplerenone (or 50mg Eplerenone) or placebo throughout the study and the dosage will be based on the serum potassium/creatine levels. Patients will be randomized 2:1 such that 36 patients in each group will receive eplerenone and 16 patients in each group will receive placebo~Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
96992|NCT01990677|E2|Reported Event|Placebo- Chronic CSCR Diagnosis|"Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 58 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient.~Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
96993|NCT01990677|E1|Reported Event|25mg Eplerenone- Chronic CSCR Diagnosis|"Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 58 days. Throughout the 58 day treatment period dosage will be adjusted. The adjustment will be based on serum potassium and creatine levels from blood draws done at Day 12 and Day 33. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.~25mg Eplerenone: Patients will be given 25mg Eplerenone (or 50mg Eplerenone) or placebo throughout the study and the dosage will be based on the serum potassium/creatine levels. Patients will be randomized 2:1 such that 36 patients in each group will receive eplerenone and 16 patients in each group will receive placebo~Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
96994|NCT01990664|B3|Baseline|Total|Total of all reporting groups
96995|NCT01990664|B2|Baseline|Test (Senofilcon A)|Consists of subjects that were dispensed at least one Test lens.
96996|NCT01990664|B1|Baseline|Control (Senfilcon A)|Consists of subjects that were dispensed at least one Control lens.
96997|NCT01990664|P2|Participant Flow|Test (Senofilcon A)|Subjects that were randomized to receive theTest lens for the duration of the study.
96999|NCT01990664|O2|Outcome|Test (Senofilcon A)|Subjects that were randomized to receive the Test lens for the duration of the study.
97000|NCT01990664|O1|Outcome|Control (Senofilcon A)|Subjects that were randomized to receive the Control lens for the duration of the study.
97001|NCT01990664|E2|Reported Event|Test (Senofilcon A)|Subjects that were randomized to receive the Test lens for the duration of the study.
97002|NCT01990664|E1|Reported Event|Control (Senofilcon A)|Subjects that were randomized to receive the Control lens for the duration of the study.
97003|NCT01990560|B1|Baseline|Mifepristone|Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
97004|NCT01990560|P1|Participant Flow|Mifepristone|Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
97005|NCT01990560|O1|Outcome|Mifepristone|Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
97006|NCT01990560|O1|Outcome|Mifepristone|Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
97007|NCT01990560|O1|Outcome|Mifepristone|Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
97008|NCT01990560|O1|Outcome|Mifepristone|Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
97009|NCT01990560|O1|Outcome|Mifepristone|Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
97010|NCT01990560|O1|Outcome|Mifepristone|Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
97011|NCT01990560|O1|Outcome|Mifepristone|Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
97012|NCT01990560|O1|Outcome|Mifepristone|Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
97013|NCT01990560|O1|Outcome|Mifepristone|Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
97014|NCT01990560|O1|Outcome|Mifepristone|Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
97015|NCT01990560|O1|Outcome|Mifepristone|Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
97016|NCT01990560|E1|Reported Event|Mifepristone|Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
97017|NCT01990534|B1|Baseline|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
97018|NCT01990534|P1|Participant Flow|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
97019|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
97020|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
97021|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
97022|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
97023|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
97024|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
97043|NCT01990261|B1|Baseline|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
97025|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
97026|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
97027|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
97028|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
97029|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
97030|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
97031|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
97032|NCT01990534|E1|Reported Event|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
97033|NCT01990339|B1|Baseline|Lansoprazole|Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.
97034|NCT01990339|P1|Participant Flow|Lansoprazole|Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.
97035|NCT01990339|O1|Outcome|Lansoprazole|Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.
97036|NCT01990339|O1|Outcome|Lansoprazole|Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.
97037|NCT01990339|E1|Reported Event|Lansoprazole|Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.
97038|NCT01990313|B1|Baseline|Activa PC+S|Activa PC+S: The Model 37604 Activa PC+S is a multiprogrammable device that can deliver therapeutic electrical stimulation and record bioelectric signals from leads implanted in the brain.
97039|NCT01990313|P1|Participant Flow|Activa PC+S|Activa PC+S: The Model 37604 Activa PC+S is a multiprogrammable device that can deliver therapeutic electrical stimulation and record bioelectric signals from leads implanted in the brain.
97040|NCT01990313|O1|Outcome|Activa PC+S|Activa PC+S: The Model 37604 Activa PC+S is a multiprogrammable device that can deliver therapeutic electrical stimulation and record bioelectric signals from leads implanted in the brain.
97041|NCT01990313|O1|Outcome|Activa PC+S|Activa PC+S: The Model 37604 Activa PC+S is a multiprogrammable device that can deliver therapeutic electrical stimulation and record bioelectric signals from leads implanted in the brain.
97042|NCT01990313|E1|Reported Event|Activa PC+S|Activa PC+S: The Model 37604 Activa PC+S is a multiprogrammable device that can deliver therapeutic electrical stimulation and record bioelectric signals from leads implanted in the brain.
97044|NCT01990261|P1|Participant Flow|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
97045|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
97046|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
97047|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
97048|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
97049|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
97050|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
97051|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
97052|NCT01990261|E1|Reported Event|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
97053|NCT01989689|B3|Baseline|Total|Total of all reporting groups
97054|NCT01989689|B2|Baseline|Placebo/Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
97055|NCT01989689|B1|Baseline|Etanercept/Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
97056|NCT01989689|P2|Participant Flow|Placebo/Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
97057|NCT01989689|P1|Participant Flow|Etanercept/Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
97058|NCT01989689|O2|Outcome|Placebo/Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
97059|NCT01989689|O1|Outcome|Etanercept/Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
97060|NCT01989689|O2|Outcome|Placebo/ Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
97061|NCT01989689|O1|Outcome|Etanercept/ Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
97062|NCT01989689|O2|Outcome|Placebo/ Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
97063|NCT01989689|O1|Outcome|Etanercept/ Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
97064|NCT01989689|E2|Reported Event|Placebo/Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
97065|NCT01989689|E1|Reported Event|Etanercept/Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
97066|NCT01989676|B3|Baseline|Total|Total of all reporting groups
97067|NCT01989676|B2|Baseline|Trastuzumab-EU|Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until at least Week 33 of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
97107|NCT01989572|O1|Outcome|Arm I (GM-CSF, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide vaccine: Given SC"
97108|NCT01989572|O6|Outcome|Arm VI (GM-CSF Placebo)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.~GM-CSF placebo: Given SC"
97068|NCT01989676|B1|Baseline|PF-05280014|Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until at least Week 33 of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
97069|NCT01989676|P2|Participant Flow|Trastuzumab-EU|Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until at least Week 33 of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
97070|NCT01989676|P1|Participant Flow|PF-05280014|Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until at least Week 33 of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
97071|NCT01989676|O2|Outcome|Trastuzumab-EU|Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until at least Week 33 of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
97072|NCT01989676|O1|Outcome|PF-05280014|Participants with HER2-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until at least Week 33 of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
97073|NCT01989676|O2|Outcome|Trastuzumab-EU|Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until at least Week 33 of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
97074|NCT01989676|O1|Outcome|PF-05280014|Participants with HER2-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until at least Week 33 of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
97075|NCT01989676|O1|Outcome|Trastuzumab-EU|Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until at least Week 33 of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
97076|NCT01989676|O1|Outcome|PF-05280014|Participants with HER2-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until at least Week 33 of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
97109|NCT01989572|O5|Outcome|Arm V (GM-CSF)|"Patients receive GM-CSF (sargramostim) SC on days 1-14.~sargramostim: Given SC"
97110|NCT01989572|O4|Outcome|Arm IV (GM-CSF Placebo, Peptide Placebo)|"Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~GM-CSF placebo: Given SC~peptide placebo: Given SC"
97152|NCT01989455|O1|Outcome|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97077|NCT01989676|O1|Outcome|Trastuzumab-EU|Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until at least Week 33 of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
97078|NCT01989676|O1|Outcome|PF-05280014|Participants with HER2-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until at least Week 33 of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
97079|NCT01989676|O2|Outcome|Trastuzumab-EU|Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until at least Week 33 of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
97080|NCT01989676|O1|Outcome|PF-05280014|Participants with HER2-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until at least Week 33 of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
97081|NCT01989676|O2|Outcome|Trastuzumab-EU|Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until at least Week 33 of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
97082|NCT01989676|O1|Outcome|PF-05280014|Participants with HER2-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until at least Week 33 of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
97083|NCT01989676|O2|Outcome|Trastuzumab-EU|Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until at least Week 33 of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
97084|NCT01989676|O1|Outcome|PF-05280014|Participants with HER2-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until at least Week 33 of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
97085|NCT01989676|O2|Outcome|Trastuzumab-EU|Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until at least Week 33 of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
97111|NCT01989572|O3|Outcome|Arm III (GM-CSF, Peptide Placebo)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide placebo: Given SC"
97153|NCT01989455|O4|Outcome|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97154|NCT01989455|O3|Outcome|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97086|NCT01989676|O1|Outcome|PF-05280014|Participants with HER2-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until at least Week 33 of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
97087|NCT01989676|E2|Reported Event|Trastuzumab-EU|Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until at least Week 33 of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
97088|NCT01989676|E1|Reported Event|PF-05280014|Participants with HER2-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until at least Week 33 of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
97089|NCT01989572|B7|Baseline|Total|Total of all reporting groups
97090|NCT01989572|B6|Baseline|Arm VI (GM-CSF Placebo)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.~GM-CSF placebo: Given SC"
97091|NCT01989572|B5|Baseline|Arm V (GM-CSF)|"Patients receive GM-CSF (sargramostim) SC on days 1-14.~sargramostim: Given SC"
97092|NCT01989572|B4|Baseline|Arm IV (GM-CSF Placebo, Peptide Placebo)|"Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~GM-CSF placebo: Given SC~peptide placebo: Given SC"
97093|NCT01989572|B3|Baseline|Arm III (GM-CSF, Peptide Placebo)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide placebo: Given SC"
97094|NCT01989572|B2|Baseline|Arm II (GM-CSF Placebo, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~peptide vaccine: Given SC~GM-CSF placebo: Given SC"
97095|NCT01989572|B1|Baseline|Arm I (GM-CSF, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide vaccine: Given SC"
97096|NCT01989572|P6|Participant Flow|Arm VI (GM-CSF Placebo)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.~GM-CSF placebo: Given SC"
97097|NCT01989572|P5|Participant Flow|Arm V (GM-CSF)|"Patients receive GM-CSF (sargramostim) SC on days 1-14.~sargramostim: Given SC"
97098|NCT01989572|P4|Participant Flow|Arm IV (GM-CSF Placebo, Peptide Placebo)|"Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~GM-CSF placebo: Given SC~peptide placebo: Given SC"
97099|NCT01989572|P3|Participant Flow|Arm III (GM-CSF, Peptide Placebo)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide placebo: Given SC"
97100|NCT01989572|P2|Participant Flow|Arm II (GM-CSF Placebo, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~peptide vaccine: Given SC~GM-CSF placebo: Given SC"
97101|NCT01989572|P1|Participant Flow|Arm I (GM-CSF, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide vaccine: Given SC"
97102|NCT01989572|O6|Outcome|Arm VI (GM-CSF Placebo)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.~GM-CSF placebo: Given SC"
97103|NCT01989572|O5|Outcome|Arm V (GM-CSF)|"Patients receive GM-CSF (sargramostim) SC on days 1-14.~sargramostim: Given SC"
97104|NCT01989572|O4|Outcome|Arm IV (GM-CSF Placebo, Peptide Placebo)|"Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~GM-CSF placebo: Given SC~peptide placebo: Given SC"
97105|NCT01989572|O3|Outcome|Arm III (GM-CSF, Peptide Placebo)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide placebo: Given SC"
97106|NCT01989572|O2|Outcome|Arm II (GM-CSF Placebo, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~peptide vaccine: Given SC~GM-CSF placebo: Given SC"
97150|NCT01989455|O3|Outcome|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97151|NCT01989455|O2|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97112|NCT01989572|O2|Outcome|Arm II (GM-CSF Placebo, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~peptide vaccine: Given SC~GM-CSF placebo: Given SC"
97113|NCT01989572|O1|Outcome|Arm I (GM-CSF, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide vaccine: Given SC"
97114|NCT01989572|O2|Outcome|Peptide Placebo|Patients who were HLA-A2 positive and received peptide placebo in the trial, including 109 patients on arms III and 107 patients on arm IV
97115|NCT01989572|O1|Outcome|Peptide Vaccination|Patients who were HLA-A2 positive and received peptide vaccine in the trial, including 109 patients on arm I and 111 patients on arm II.
97116|NCT01989572|O2|Outcome|Peptide Placebo|Patients who were HLA-A2 positive and received peptide placebo in the trial, including 109 patients on arms III and 107 patients on arm IV
97117|NCT01989572|O1|Outcome|Peptide Vaccination|Patients who were HLA-A2 positive and received peptide vaccine in the trial, including 109 patients on arm I and 111 patients on arm II.
97118|NCT01989572|O2|Outcome|GM-CSF Placebo|Patients who did not receive GM-CSF (ie, received GM-CSF placebo) in the trial, including patients on arms II, IV and VI
97119|NCT01989572|O1|Outcome|GM-CSF|Patients received GM-CSF in the trial, including patients on arms I, III, V.
97120|NCT01989572|O2|Outcome|GM-CSF Placebo|Patients who did not receive GM-CSF (ie, received GM-CSF placebo) in the trial, including patients on arms II, IV and VI
97121|NCT01989572|O1|Outcome|GM-CSF|Patients received GM-CSF in the trial, including patients on arms I, III, V.
97122|NCT01989572|E6|Reported Event|Arm VI (GM-CSF Placebo)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.~GM-CSF placebo: Given SC"
97123|NCT01989572|E5|Reported Event|Arm V (GM-CSF)|"Patients receive GM-CSF (sargramostim) SC on days 1-14.~sargramostim: Given SC"
97124|NCT01989572|E4|Reported Event|Arm IV (GM-CSF Placebo, Peptide Placebo)|"Arm IV (GM-CSF placebo, peptide placebo) Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~GM-CSF placebo: Given SC peptide placebo: Given SC"
97125|NCT01989572|E3|Reported Event|Arm III (GM-CSF, Peptide Placebo)|"Arm III (GM-CSF, peptide placebo) Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC peptide placebo: Given SC"
97126|NCT01989572|E2|Reported Event|Arm II (GM-CSF Placebo, Peptide Vaccine)|"Arm II (GM-CSF placebo, peptide vaccine) Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~peptide vaccine: Given SC GM-CSF placebo: Given SC"
97127|NCT01989572|E1|Reported Event|Arm I (GM-CSF, Peptide Vaccine)|"Arm I (GM-CSF, peptide vaccine) Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC peptide vaccine: Given SC"
97128|NCT01989455|B6|Baseline|Total|Total of all reporting groups
97129|NCT01989455|B5|Baseline|Placebo|Single intravenous dose of placebo (normal saline solution).
97130|NCT01989455|B4|Baseline|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97131|NCT01989455|B3|Baseline|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97132|NCT01989455|B2|Baseline|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97133|NCT01989455|B1|Baseline|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97134|NCT01989455|P5|Participant Flow|Placebo|Single intravenous dose of placebo (normal saline solution).
97135|NCT01989455|P4|Participant Flow|2000 mg Deferiprone|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97136|NCT01989455|P3|Participant Flow|1500 mg Deferiprone|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97137|NCT01989455|P2|Participant Flow|1000 mg Deferiprone|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL), followed one week later by a single oral dose of 1000 mg deferiprone oral solution, 80 mg/mL
97138|NCT01989455|P1|Participant Flow|500 mg Deferiprone|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97139|NCT01989455|O1|Outcome|1000 mg Oral Deferiprone|Single oral dose of 1000 mg deferiprone (deferiprone oral solution, 80 mg/mL)
97140|NCT01989455|O2|Outcome|1000 mg Oral Deferiprone|Single oral dose of 1000 mg deferiprone (deferiprone oral solution, 80 mg/mL)
97141|NCT01989455|O1|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97142|NCT01989455|O2|Outcome|1000 mg Oral Deferiprone|Single oral dose of 1000 mg deferiprone (deferiprone oral solution, 80 mg/mL)
97143|NCT01989455|O1|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97144|NCT01989455|O5|Outcome|Placebo|Single intravenous dose of placebo (normal saline solution).
97145|NCT01989455|O4|Outcome|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97146|NCT01989455|O3|Outcome|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97147|NCT01989455|O2|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97148|NCT01989455|O1|Outcome|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97149|NCT01989455|O4|Outcome|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97155|NCT01989455|O2|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97156|NCT01989455|O1|Outcome|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97157|NCT01989455|O4|Outcome|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97158|NCT01989455|O3|Outcome|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97159|NCT01989455|O2|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97160|NCT01989455|O1|Outcome|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97161|NCT01989455|O4|Outcome|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97162|NCT01989455|O3|Outcome|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97163|NCT01989455|O2|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97164|NCT01989455|O1|Outcome|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97165|NCT01989455|E6|Reported Event|1000 mg Oral Deferiprone|Single oral dose of 1000 mg deferiprone (deferiprone oral solution, 80 mg/mL)
97166|NCT01989455|E5|Reported Event|Placebo|Single intravenous dose of placebo (normal saline solution).
97167|NCT01989455|E4|Reported Event|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97168|NCT01989455|E3|Reported Event|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97169|NCT01989455|E2|Reported Event|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97170|NCT01989455|E1|Reported Event|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
97171|NCT01989195|B1|Baseline|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~‘SEEMORE’ - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
97172|NCT01989195|P1|Participant Flow|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~‘SEEMORE’ - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
97173|NCT01989195|O1|Outcome|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~‘SEEMORE’ - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
97174|NCT01989195|O1|Outcome|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~‘SEEMORE’ - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI~Outcome measurement followed for both as all subjects received both MEMRI and DEMRI."
97175|NCT01989195|O1|Outcome|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~‘SEEMORE’ - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
97176|NCT01989195|O2|Outcome|INVESTIGATIONAL MANGANESE-ENHANCED MRI (MEMRI)|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~MEMRI- SeeMore~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MR"
97177|NCT01989195|O1|Outcome|DEMRI CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~DEMRI - MAGNEVIST (GADOLINIUM)~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
97178|NCT01989195|E1|Reported Event|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~‘SEEMORE’ - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH CLINICAL MAGNEVIST (GADOLINIUM), ONE WITH EXPERIMENTAL SEEMORE (MANGANESE) REAGENT. ADVERSE EVENTS TRACKED FOR SEEMORE MRI.~- CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
97179|NCT01989169|B3|Baseline|Total|Total of all reporting groups
97180|NCT01989169|B2|Baseline|Midazolam + SSP-004184SS First|Subjects received Midazolam 6mg and SSP-004184SS 30mg/kg in Period 1, followed by Midazolam 6mg during Period 2.
97181|NCT01989169|B1|Baseline|Midazolam First|Subjects received Midazolam 6mg in Period 1, followed by Midazolam 6mg and SSP-004184SS 30mg/kg during Period 2.
97182|NCT01989169|P2|Participant Flow|Midazolam + SSP-004184SS First|Subjects received Midazolam 6mg and SSP-004184SS 30mg/kg in Period 1, followed by Midazolam 6mg during Period 2.
97183|NCT01989169|P1|Participant Flow|Midazolam First|Subjects received Midazolam 6mg in Period 1, followed by Midazolam 6mg and SSP-004184SS 30mg/kg during Period 2.
97184|NCT01989169|O2|Outcome|SSP-004184SS + Midazolam|Midazolam (6 mg) + SSP-004184SS (30 mg/kg) concomitantly administered as a single oral dose on Day 1.
97185|NCT01989169|O1|Outcome|Midazolam|Administered as a single oral 6 mg dose on Day 1.
97186|NCT01989169|O2|Outcome|SSP-004184SS + Midazolam|Midazolam (6 mg) + SSP-004184SS (30 mg/kg) concomitantly administered as a single oral dose on Day 1.
97188|NCT01989169|O2|Outcome|SSP-004184SS + Midazolam|Midazolam (6 mg) + SSP-004184SS (30 mg/kg) concomitantly administered as a single oral dose on Day 1.
97189|NCT01989169|O1|Outcome|Midazolam|Administered as a single oral 6 mg dose on Day 1.
97190|NCT01989169|E2|Reported Event|Midazolam + SSP-004184SS|Midazolam (6 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
97191|NCT01989169|E1|Reported Event|Midazolam Alone|Administered as a single oral 20 mg dose on Day 1.
97192|NCT01989156|B4|Baseline|Total|Total of all reporting groups
97193|NCT01989156|B3|Baseline|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
97194|NCT01989156|B2|Baseline|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
97195|NCT01989156|B1|Baseline|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
97196|NCT01989156|P3|Participant Flow|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
97197|NCT01989156|P2|Participant Flow|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
97198|NCT01989156|P1|Participant Flow|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
97199|NCT01989156|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
97200|NCT01989156|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
97201|NCT01989156|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
97202|NCT01989156|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
97203|NCT01989156|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
97204|NCT01989156|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
97205|NCT01989156|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
97206|NCT01989156|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
97207|NCT01989156|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
97208|NCT01989156|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
97209|NCT01989156|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
97210|NCT01989156|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
97211|NCT01989156|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
97212|NCT01989156|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
97213|NCT01989156|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
97214|NCT01989156|E3|Reported Event|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
97215|NCT01989156|E2|Reported Event|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
97216|NCT01989156|E1|Reported Event|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
97217|NCT01989130|B3|Baseline|Total|Total of all reporting groups
97218|NCT01989130|B2|Baseline|Batched Results With Roche AMPLICOR CT/NG Test|"Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED~Roche AMPLICOR CT/NG"
97219|NCT01989130|B1|Baseline|Real-time Results With Cepheid Xpert CT/NG Test|"Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory~Cepheid Xpert CT/NG Test"
97220|NCT01989130|P2|Participant Flow|Batched Results With Roche AMPLICOR CT/NG Test|"Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED~Roche AMPLICOR CT/NG"
97221|NCT01989130|P1|Participant Flow|Real-time Results With Cepheid Xpert CT/NG Test|"Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory~Cepheid Xpert CT/NG Test"
97222|NCT01989130|O2|Outcome|Batched Results With Roche AMPLICOR CT/NG Test|"Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED~Roche AMPLICOR CT/NG"
97223|NCT01989130|O1|Outcome|Real-time Results With Cepheid Xpert CT/NG Test|"Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory~Cepheid Xpert CT/NG Test"
97224|NCT01989130|O2|Outcome|Batched Results With Roche AMPLICOR CT/NG Test|"Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED~Roche AMPLICOR CT/NG"
97225|NCT01989130|O1|Outcome|Real-time Results With Cepheid Xpert CT/NG Test|"Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory~Cepheid Xpert CT/NG Test"
97226|NCT01989130|O2|Outcome|Batched Results With Roche AMPLICOR CT/NG Test|"Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED~Roche AMPLICOR CT/NG"
97227|NCT01989130|O1|Outcome|Real-time Results With Cepheid Xpert CT/NG Test|"Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory~Cepheid Xpert CT/NG Test"
97228|NCT01989130|O2|Outcome|Batched Results With Roche AMPLICOR CT/NG Test|"Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED~Roche AMPLICOR CT/NG"
97229|NCT01989130|O1|Outcome|Real-time Results With Cepheid Xpert CT/NG Test|"Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory~Cepheid Xpert CT/NG Test"
97230|NCT01989130|E2|Reported Event|Batched Results With Roche AMPLICOR CT/NG Test|"Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED~Roche AMPLICOR CT/NG"
97231|NCT01989130|E1|Reported Event|Real-time Results With Cepheid Xpert CT/NG Test|"Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory~Cepheid Xpert CT/NG Test"
97232|NCT01988922|B4|Baseline|Total|Total of all reporting groups
97233|NCT01988922|B3|Baseline|Ketamine Arm - *6/*6|"3. *6/*6- oral racemic ketamine 0.4 mg/kg~ketamine: 0.4 mg/kg oral racemic ketamine"
97234|NCT01988922|B2|Baseline|Ketamine Arm - *1/*6|"2. *1/*6- oral racemic ketamine 0.4 mg/kg~ketamine: 0.4 mg/kg oral racemic ketamine"
97235|NCT01988922|B1|Baseline|Ketamine Arm- *1/*1|"1.*1/*1- oral racemic ketamine 0.4 mg/kg~ketamine: 0.4 mg/kg oral racemic ketamine"
97236|NCT01988922|P3|Participant Flow|Ketamine Arm - *6/*6|"3. *6/*6- oral racemic ketamine 0.4 mg/kg~ketamine: 0.4 mg/kg oral racemic ketamine as a one-time dose"
97237|NCT01988922|P2|Participant Flow|Ketamine Arm - *1/*6|"2. *1/*6- oral racemic ketamine 0.4 mg/kg~ketamine: 0.4 mg/kg oral racemic ketamine as a one-time dose"
97238|NCT01988922|P1|Participant Flow|Ketamine Arm- *1/*1|"1.*1/*1- oral racemic ketamine 0.4 mg/kg~ketamine: 0.4 mg/kg oral racemic ketamine as a one-time dose"
97239|NCT01988922|O6|Outcome|S-ketamine *6/*6|
97240|NCT01988922|O5|Outcome|R-ketamine *6/*6|
97241|NCT01988922|O4|Outcome|S-ketamine *1/*6|
97242|NCT01988922|O3|Outcome|R-ketamine *1/*6|
97243|NCT01988922|O2|Outcome|S-ketamine *1/*1|
97244|NCT01988922|O1|Outcome|R-ketamine *1/*1|
97245|NCT01988922|E3|Reported Event|Ketamine Arm - *6/*6|"3. *6/*6- oral racemic ketamine 0.4 mg/kg~ketamine: 0.4 mg/kg oral racemic ketamine"
97246|NCT01988922|E2|Reported Event|Ketamine Arm - *1/*6|"2. *1/*6- oral racemic ketamine 0.4 mg/kg~ketamine: 0.4 mg/kg oral racemic ketamine"
97247|NCT01988922|E1|Reported Event|Ketamine Arm- *1/*1|"1.*1/*1- oral racemic ketamine 0.4 mg/kg~ketamine: 0.4 mg/kg oral racemic ketamine"
97248|NCT01988857|B1|Baseline|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
97249|NCT01988857|P1|Participant Flow|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
97250|NCT01988857|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
97251|NCT01988857|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
97252|NCT01988857|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
97253|NCT01988857|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
97254|NCT01988857|E1|Reported Event|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
97255|NCT01988662|B3|Baseline|Total|Total of all reporting groups
97256|NCT01988662|B2|Baseline|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
97257|NCT01988662|B1|Baseline|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
97258|NCT01988662|P2|Participant Flow|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
97259|NCT01988662|P1|Participant Flow|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
97260|NCT01988662|O2|Outcome|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
97261|NCT01988662|O1|Outcome|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
97262|NCT01988662|O2|Outcome|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
97263|NCT01988662|O1|Outcome|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
97264|NCT01988662|O2|Outcome|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
97265|NCT01988662|O1|Outcome|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
97266|NCT01988662|O2|Outcome|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
97267|NCT01988662|O1|Outcome|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
97496|NCT01987895|B2|Baseline|Vancomycin|Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
97268|NCT01988662|O2|Outcome|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
97269|NCT01988662|O1|Outcome|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
97270|NCT01988662|O2|Outcome|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
97271|NCT01988662|O1|Outcome|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
97272|NCT01988662|E3|Reported Event|Total|
97273|NCT01988662|E2|Reported Event|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
97274|NCT01988662|E1|Reported Event|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
97275|NCT01988415|B1|Baseline|VSS-Rx1 OPM vs Commercial iDesign Treatment|Commercially available software used to calculate the LASIK treatment profile in one eye (active comparator [i.e., control]) and investigational software (includes a modified algorithm designed to reduce the induction of postoperative spherical aberration) in the fellow eye (experimental).
97276|NCT01988415|P1|Participant Flow|VSS-Rx1 OPM vs Commercial iDesign Treatment|Commercially available software used to calculate the LASIK treatment profile in one eye (active comparator [i.e., control]) and investigational software (includes a modified algorithm designed to reduce the induction of postoperative spherical aberration) in the fellow eye (experimental).
97277|NCT01988415|O2|Outcome|VSS-Rx1 OPM Treatment Planning Software|Investigational treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the VSS-Rx1 OPM treatment planning software
97278|NCT01988415|O1|Outcome|Commercial iDesign Treatment Planning Software|Commercial iDesign treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the commercial iDesign treatment planning software
97279|NCT01988415|O2|Outcome|VSS-Rx1 OPM Treatment Planning Software|Investigational treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the VSS-Rx1 OPM treatment planning software
97280|NCT01988415|O1|Outcome|Commercial iDesign Treatment Planning Software|Commercial iDesign treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the commercial iDesign treatment planning software
97281|NCT01988415|E2|Reported Event|VSS-Rx1 OPM Treatment Planning Software|Investigational treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the VSS-Rx1 OPM treatment planning software
97282|NCT01988415|E1|Reported Event|Commercial iDesign Treatment Planning Software|Commercial iDesign treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the commercial iDesign treatment planning software
97283|NCT01988402|B3|Baseline|Total|Total of all reporting groups
97284|NCT01988402|B2|Baseline|Sugar Pill (Placebo)|"Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.~Placebo (sugar pill)"
97285|NCT01988402|B1|Baseline|Allopurinol|"Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days~allopurinol"
97286|NCT01988402|P2|Participant Flow|Sugar Pill (Placebo)|"Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.~Placebo (sugar pill)"
97287|NCT01988402|P1|Participant Flow|Allopurinol|"Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days~allopurinol"
97288|NCT01988402|O2|Outcome|Sugar Pill (Placebo)|"Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.~Placebo (sugar pill)"
97289|NCT01988402|O1|Outcome|Allopurinol|"Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days~allopurinol"
97290|NCT01988402|O2|Outcome|Sugar Pill (Placebo)|"Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.~Placebo (sugar pill)"
97291|NCT01988402|O1|Outcome|Allopurinol|"Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days~allopurinol"
97292|NCT01988402|O2|Outcome|Sugar Pill (Placebo)|"Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.~Placebo (sugar pill)"
97293|NCT01988402|O1|Outcome|Allopurinol|"Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days~allopurinol"
97294|NCT01988402|O2|Outcome|Sugar Pill (Placebo)|"Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.~Placebo (sugar pill)"
97295|NCT01988402|O1|Outcome|Allopurinol|"Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days~allopurinol"
97296|NCT01988402|E2|Reported Event|Sugar Pill (Placebo)|"Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.~Placebo (sugar pill)"
97297|NCT01988402|E1|Reported Event|Allopurinol|"Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days~allopurinol"
97298|NCT01988129|B3|Baseline|Total|Total of all reporting groups
97299|NCT01988129|B2|Baseline|Control|Current practice
97363|NCT01987986|O4|Outcome|Placebo|"Placebo~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Placebo"
97300|NCT01988129|B1|Baseline|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
97301|NCT01988129|P2|Participant Flow|Control|"Current practice.~Current practice. Firefighters in the Control Stations continued their normal role and were not invited to attend the sleep education and sleep disorders screening program. There was no formal contact with the control group.~As part of normal operational requirements, a small number of firefighters are reassigned to other stations each day and therefore 18/588 firefighters from control stations happened to be reassigned to an intervention station on the day of the education session and attended the session."
97302|NCT01988129|P1|Participant Flow|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening.~32 stations were paired according to workload. One from each pair was randomized to receive the intervention program. Firefighters were instructed to attend an education presentation which provided information on firefighter mortality, fatigue-related hazards and discussed the importance of sleep, and included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
97303|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
97304|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
97305|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
97306|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
97307|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
97308|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
97309|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
97310|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
97311|NCT01988129|O1|Outcome|Baseline (Intervention)|Firefighters in the intervention group who volunteered to complete the sleep disorders screening survey
97313|NCT01988129|O1|Outcome|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
97314|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
97315|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
97316|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
97317|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
97318|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
97319|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
97320|NCT01988129|O2|Outcome|Control|Current practice
97321|NCT01988129|O1|Outcome|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
97322|NCT01988129|O2|Outcome|Control|Current practice
97323|NCT01988129|O1|Outcome|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
97324|NCT01988129|O2|Outcome|Control|Current practice
97339|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
97364|NCT01987986|O3|Outcome|AA4500 0.84 mg (High Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97325|NCT01988129|O1|Outcome|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
97326|NCT01988129|E2|Reported Event|Control|A total of 15/588 firefighters in the control stations who were temporarily assigned to duty in the intervention stations on the day of the survey completed the screening survey. The remaining 573 firefighters did not complete the survey and therefore there are no adverse event data to report.
97327|NCT01988129|E1|Reported Event|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, including strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey which used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. Those who screened positive for any sleep disorder were notified as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up. Of the 431 firefighters completed the sleep disorders screening survey, 416 were from the intervention stations."
97328|NCT01988012|B1|Baseline|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
97329|NCT01988012|P1|Participant Flow|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 milligram (mg) tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
97330|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
97331|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
97332|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
97333|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
97334|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
97335|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
97336|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
97337|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
97338|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
97362|NCT01987986|O1|Outcome|AA4500 0.06 mg (Low Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97417|NCT01987908|O1|Outcome|Overall Study Arm|
97340|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
97341|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
97342|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
97343|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
97344|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
97345|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
97346|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
97347|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
97348|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
97349|NCT01988012|E1|Reported Event|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
97350|NCT01987986|B5|Baseline|Total|Total of all reporting groups
97351|NCT01987986|B4|Baseline|Placebo|"Placebo~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Placebo"
97352|NCT01987986|B3|Baseline|AA4500 0.84 mg (High Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97353|NCT01987986|B2|Baseline|AA4500 0.48 mg (Mid-dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97354|NCT01987986|B1|Baseline|AA4500 0.06 mg (Low Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97355|NCT01987986|P4|Participant Flow|Placebo|"Placebo~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Placebo"
97356|NCT01987986|P3|Participant Flow|AA4500 0.84 mg (High Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97357|NCT01987986|P2|Participant Flow|AA4500 0.48 mg (Mid-dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97358|NCT01987986|P1|Participant Flow|AA4500 0.06 mg (Low Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97359|NCT01987986|O4|Outcome|Placebo|"Placebo~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Placebo"
97360|NCT01987986|O3|Outcome|AA4500 0.84 mg (High Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97361|NCT01987986|O2|Outcome|AA4500 0.48 mg (Mid-dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97365|NCT01987986|O2|Outcome|AA4500 0.48 mg (Mid-dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97366|NCT01987986|O1|Outcome|AA4500 0.06 mg (Low Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97367|NCT01987986|O4|Outcome|Placebo|"Placebo~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Placebo"
97368|NCT01987986|O3|Outcome|AA4500 0.84 mg (High Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97369|NCT01987986|O2|Outcome|AA4500 0.48 mg (Mid-dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97370|NCT01987986|O1|Outcome|AA4500 0.06 mg (Low Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97371|NCT01987986|O4|Outcome|Placebo|"Placebo~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Placebo"
97372|NCT01987986|O3|Outcome|AA4500 0.84 mg (High Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97373|NCT01987986|O2|Outcome|AA4500 0.48 mg (Mid-dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97374|NCT01987986|O1|Outcome|AA4500 0.06 mg (Low Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97375|NCT01987986|O4|Outcome|Placebo|"Placebo~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Placebo"
97376|NCT01987986|O3|Outcome|AA4500 0.84 mg (High Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97377|NCT01987986|O2|Outcome|AA4500 0.48 mg (Mid-dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97378|NCT01987986|O1|Outcome|AA4500 0.06 mg (Low Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97379|NCT01987986|O4|Outcome|Placebo|"Placebo~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Placebo"
97380|NCT01987986|O3|Outcome|AA4500 0.84 mg (High Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97381|NCT01987986|O2|Outcome|AA4500 0.48 mg (Mid-dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97382|NCT01987986|O1|Outcome|AA4500 0.06 mg (Low Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97383|NCT01987986|O4|Outcome|Placebo|"Placebo~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Placebo"
97384|NCT01987986|O3|Outcome|AA4500 0.84 mg (High Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97385|NCT01987986|O2|Outcome|AA4500 0.48 mg (Mid-dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97386|NCT01987986|O1|Outcome|AA4500 0.06 mg (Low Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97387|NCT01987986|O4|Outcome|Placebo|"Placebo~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Placebo"
97388|NCT01987986|O3|Outcome|AA4500 0.84 mg (High Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97389|NCT01987986|O2|Outcome|AA4500 0.48 mg (Mid-dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97390|NCT01987986|O1|Outcome|AA4500 0.06 mg (Low Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97391|NCT01987986|E4|Reported Event|Placebo|"Placebo~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Placebo"
97495|NCT01987895|B3|Baseline|Total|Total of all reporting groups
97392|NCT01987986|E3|Reported Event|AA4500 0.84 mg (High Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97393|NCT01987986|E2|Reported Event|AA4500 0.48 mg (Mid-dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97394|NCT01987986|E1|Reported Event|AA4500 0.06 mg (Low Dose)|"AA4500 (Collagenase Clostridium Histolyticum)~Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.~Collagenase Clostridium Histolyticum: injectible intervention"
97395|NCT01987960|B3|Baseline|Total|Total of all reporting groups
97396|NCT01987960|B2|Baseline|Period 2 Brexpiprazole and PAR/SER (Randomized Period)|"Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period.~Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally"
97397|NCT01987960|B1|Baseline|Period 2 Placebo and PAR/SER (Randomized Period)|"Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.~Placebo: Once daily, tablets, orally"
97398|NCT01987960|P4|Participant Flow|Period 3 Placebo and PAR/SER|"Continuation of treatment with placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER) from Period 1.~Placebo: Once daily, tablets, orally"
97399|NCT01987960|P3|Participant Flow|Period 2 Brexpiprazole and PAR/SER (Randomized Period)|"Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period~Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally"
97400|NCT01987960|P2|Participant Flow|Period 2 Placebo and PAR/SER (Randomized Period)|"Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.~Placebo: Once daily, tablets, orally"
97401|NCT01987960|P1|Participant Flow|Period 1 Placebo and PAR/SER|"Placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER).~Placebo: Once daily, tablets, orally"
97402|NCT01987960|O4|Outcome|Period 2 Absolute Mean at Week 12; Brexpiprazole and PAR/SER|"Period 2 absolute mean value at Week 12; Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.~Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day. Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally Absolute values at Week 12 in Period 2 (Study Week 24)."
97403|NCT01987960|O3|Outcome|Period 2 Absolute Mean at Week 12; Placebo and PAR/SER|Period 2 absolute mean value at Week 12; Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER) Placebo: Once daily, tablets, orally Absolute values at Week 12 in Period 2 (Study Week 24); randomized period.
97404|NCT01987960|O2|Outcome|Period 2 Absolute Mean at Baseline; Brexpiprazole and PAR/SER|"Period 2 absolute mean value at Baseline; Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period.~Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally"
97405|NCT01987960|O1|Outcome|Period 2 Absolute Mean at Baseline; Placebo and PAR/SER|"Period 2 absolute mean value at Baseline; Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.~Placebo: Once daily, tablets, orally"
97406|NCT01987960|O4|Outcome|Period 2 Absolute Mean at Week 12; Brexpiprazole and PAR/SER|"Period 2 absolute mean value at Week 12; Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period.~Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally~Absolute values at Week 12 in Period 2 (Study Week 24)"
97407|NCT01987960|O3|Outcome|Period 2 Absolute Mean at Week 12; Placebo and PAR/SER|"Period 2 absolute mean value at Week 12; Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.~Placebo: Once daily, tablets, orally~Absolute values at Week 12 in Period 2 (Study Week 24)"
97408|NCT01987960|O2|Outcome|Period 2 Absolute Mean at Baseline; Brexpiprazole and PAR/SER|"Period 2 absolute mean value at Baseline; Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period.~Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally"
97409|NCT01987960|O1|Outcome|Period 2 Absolute Mean at Baseline; Placebo and PAR/SER|"Period 2 absolute mean value at Baseline; Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.~Placebo: Once daily, tablets, orally"
97410|NCT01987960|E2|Reported Event|Placebo + PAR/SER (Randomized Period)|
97411|NCT01987960|E1|Reported Event|Brexpiprazole + PAR/SER (Randomized Period)|
97412|NCT01987908|B1|Baseline|Placebo lead-in Period|Participants enrolled in a 14 day single-blind placebo lead-in received 4 times daily dosing of placebo
97413|NCT01987908|P3|Participant Flow|Treatment With Placebo|After placebo lead-in period, participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days during the double-blind treatment period
97414|NCT01987908|P2|Participant Flow|Treatment With Study Product|After placebo lead-in period, participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days during the double-blind treatment period
97415|NCT01987908|P1|Participant Flow|Placebo lead-in Period|Participants enrolled in a 14 day single-blind placebo lead-in received 4 times daily dosing of placebo
97416|NCT01987908|O1|Outcome|Overall Study Arm|
97418|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
97419|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
97420|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
97421|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
97422|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
97423|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
97424|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
97425|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
97426|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
97427|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
97428|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
97429|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
97430|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
97431|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
97432|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
97433|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
97434|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
97435|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
97436|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
97437|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
97438|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
97439|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
97440|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
97441|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
97442|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
97443|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
97444|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
97445|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
97446|NCT01987908|O1|Outcome|Overall Study Arm|
97447|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
97448|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
97449|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
97450|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
97451|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
97452|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
97453|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
97454|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
97455|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
97456|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
97457|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
97458|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
97459|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
97460|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
97461|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
97462|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
97463|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
97464|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
97465|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
97466|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
97467|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
97468|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
97469|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
97470|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
97471|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
97472|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
97473|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
97474|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
97475|NCT01987908|O1|Outcome|Overall Study Arm|Data not collected
97476|NCT01987908|O4|Outcome|Post-treatment Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) or placebo was received (Day 29 to Day 49)
97477|NCT01987908|O3|Outcome|Double-blind Treatment Period - Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of placebo for 28 days (Day 1 to Day 28)
97478|NCT01987908|O2|Outcome|Double-blind Treatment Period - Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days (Day 1 to Day 28)
97479|NCT01987908|O1|Outcome|Placebo lead-in Period|Participants enrolled in a 14 day single-blind placebo lead-in received 4 times daily dosing of placebo (Day -14 to Day -1)
97480|NCT01987908|O5|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no placebo was received
97481|NCT01987908|O4|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
97482|NCT01987908|O3|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
97483|NCT01987908|O2|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
97484|NCT01987908|O1|Outcome|Placebo Lead-in Period|Participants enrolled in a 14 day single-blind placebo lead-in received 4 times daily dosing of placebo
97485|NCT01987908|O3|Outcome|All Participants in Post-treatment Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) or placebo was received
97486|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no placebo was received
97487|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
97488|NCT01987908|O1|Outcome|Placebo lead-in Period|Participants enrolled in a 14 day single-blind placebo lead-in received 4 times daily dosing of placebo
97489|NCT01987908|O3|Outcome|All Treated Participants|All participants randomized 3:1 (Aes-103 to placebo) and received 4 times daily dosing of 1,000 mg AEs-103 or 1,000 mg of placebo for 28 days
97490|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
97491|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
97492|NCT01987908|E3|Reported Event|Post-treatment Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) or placebo was received (Day 29 to Day 49)
97493|NCT01987908|E2|Reported Event|Double-blind Treatment Period|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of either 1,000 mg of Aes-103 (study product) or placebo for 28 days (Day 1 to Day 28)
97494|NCT01987908|E1|Reported Event|Placebo lead-in Period|Participants enrolled in a 14 day single-blind placebo lead-in received 4 times daily dosing of placebo (Day -14 to Day -1)
97497|NCT01987895|B1|Baseline|Cadazolid|Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
97498|NCT01987895|P2|Participant Flow|Vancomycin|Subjects with CDAD received oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days. Subjects were followed up for 30 day after the last dose of vancomycin. Subjects who had a first recurrence of CDAD during the follow-up period were offered to enter a re-treatment extension period with cadazolid (10 day of cadazolid + 30-day follow up)
97499|NCT01987895|P1|Participant Flow|Cadazolid|Subjects with Clostridium difficile-associated diarrhea (CDAD) received oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times a day (qid) for 10 days. Subjects were followed up for 30 days after the last dose of cadazolid. Subjects who had a first recurrence of CDAD during the follow-up period were offered to enter a re-treatment extension period with cadazolid (10 day of cadazolid + 30-day follow up)
97500|NCT01987895|O2|Outcome|Vancomycin|Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
97501|NCT01987895|O1|Outcome|Cadazolid|Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
97502|NCT01987895|O2|Outcome|Vancomycin|Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
97503|NCT01987895|O1|Outcome|Cadazolid|Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
97504|NCT01987895|O2|Outcome|Vancomycin|Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
97505|NCT01987895|O1|Outcome|Cadazolid|Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
97506|NCT01987895|O2|Outcome|Vancomycin|Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
97507|NCT01987895|O1|Outcome|Cadazolid|Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
97508|NCT01987895|O2|Outcome|Vancomycin|Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
97509|NCT01987895|O1|Outcome|Cadazolid|Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
97510|NCT01987895|O2|Outcome|Vancomycin|Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
97511|NCT01987895|O1|Outcome|Cadazolid|Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
97512|NCT01987895|O2|Outcome|Vancomycin|Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
97513|NCT01987895|O1|Outcome|Cadazolid|Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
97514|NCT01987895|O2|Outcome|Vancomycin|Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
97515|NCT01987895|O1|Outcome|Cadazolid|Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
97516|NCT01987895|O2|Outcome|Vancomycin|Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
97517|NCT01987895|O1|Outcome|Cadazolid|Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
97518|NCT01987895|O2|Outcome|Vancomycin|Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
97519|NCT01987895|O1|Outcome|Cadazolid|Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
97520|NCT01987895|E2|Reported Event|Vancomycin|322 subjects received at least one dose of vancomycin and were included in the safety analysis. The median duration of treatment with vancomycin was 10 days.
97521|NCT01987895|E1|Reported Event|Cadazolid|304 subjects received at least one dose of cadazolid and were included in the safety analysis. The median duration of treatment with cadazolid was 10 days.
97522|NCT01987765|B1|Baseline|Relestat Ophthalmic Solution 0.05%|Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
97523|NCT01987765|P1|Participant Flow|Relestat Ophthalmic Solution 0.05%|Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
97524|NCT01987765|O1|Outcome|Relestat Ophthalmic Solution 0.05%|Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
97525|NCT01987765|O1|Outcome|Relestat Ophthalmic Solution 0.05%|Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
97526|NCT01987765|E1|Reported Event|Relestat Ophthalmic Solution 0.05%|Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
97527|NCT01987752|B1|Baseline|Combigan® Ophthalmic Solution|Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
97528|NCT01987752|P1|Participant Flow|Combigan® Ophthalmic Solution|Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
97529|NCT01987752|O1|Outcome|Combigan® Ophthalmic Solution|Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
97530|NCT01987752|O1|Outcome|Combigan® Ophthalmic Solution|Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
97531|NCT01987752|E1|Reported Event|Combigan® Ophthalmic Solution|Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
97532|NCT01987583|B3|Baseline|Total|Total of all reporting groups
97533|NCT01987583|B2|Baseline|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
97890|NCT01986361|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
97534|NCT01987583|B1|Baseline|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions every other day, on the 17th, 19th and 21st days of the lunar month.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
97535|NCT01987583|P2|Participant Flow|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
97536|NCT01987583|P1|Participant Flow|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions every other day, on the 17th, 19th and 21st days of the lunar month.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
97537|NCT01987583|O2|Outcome|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
97538|NCT01987583|O1|Outcome|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions every other day, on the 17th, 19th and 21st days of the lunar month.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
97539|NCT01987583|O2|Outcome|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
97540|NCT01987583|O1|Outcome|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions every other day, on the 17th, 19th and 21st days of the lunar month.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
97541|NCT01987583|E2|Reported Event|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
97542|NCT01987583|E1|Reported Event|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions every other day, on the 17th, 19th and 21st days of the lunar month.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
97543|NCT01987557|B4|Baseline|Total|Total of all reporting groups
97544|NCT01987557|B3|Baseline|Regular Treadmill Walking|"participants will walk at a comfortable self-selected pace on a treadmill~regular treadmill walking"
97545|NCT01987557|B2|Baseline|Magnitude Treadmill Group|"In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs~magnitude treadmill group"
97573|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
97546|NCT01987557|B1|Baseline|Treadmill Intervention 1: Rate Group|"Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.~rate group: walking with a high cadence (steps per minute)"
97547|NCT01987557|P3|Participant Flow|Regular Treadmill Walking|"participants will walk at a comfortable self-selected pace on a treadmill~regular treadmill walking"
97548|NCT01987557|P2|Participant Flow|Magnitude Treadmill Group|"In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs~magnitude treadmill group"
97549|NCT01987557|P1|Participant Flow|Treadmill Intervention 1: Rate Group|"Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.~rate group: walking with a high cadence (steps per minute)"
97550|NCT01987557|O3|Outcome|Regular Treadmill Walking|"participants will walk at a comfortable self-selected pace on a treadmill~regular treadmill walking"
97551|NCT01987557|O2|Outcome|Magnitude Treadmill Group|"In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs~magnitude treadmill group"
97552|NCT01987557|O1|Outcome|Treadmill Intervention 1: Rate Group|"Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.~rate group: walking with a high cadence (steps per minute)"
97553|NCT01987557|E3|Reported Event|Regular Treadmill Walking|"participants will walk at a comfortable self-selected pace on a treadmill~regular treadmill walking"
97554|NCT01987557|E2|Reported Event|Magnitude Treadmill Group|"In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs~magnitude treadmill group"
97555|NCT01987557|E1|Reported Event|Treadmill Intervention 1: Rate Group|"Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.~rate group: walking with a high cadence (steps per minute)"
97556|NCT01987479|B1|Baseline|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
97557|NCT01987479|P1|Participant Flow|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly subcutaneous (SC) injection of tocilizumab 162 milligrams (mg) as monotherapy or in combination with methotrexate or other non-biologic disease modifying antirheumatic drugs (DMARDs) for 24 weeks.
97558|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
97559|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
97560|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
97561|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
97562|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
97563|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
97564|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
97565|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
97566|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
97567|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
97568|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
97569|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
97570|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
97571|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
97572|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
97574|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
97575|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
97576|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
97577|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
97578|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
97579|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
97580|NCT01987479|E1|Reported Event|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
97581|NCT01987453|B4|Baseline|Total|Total of all reporting groups
97582|NCT01987453|B3|Baseline|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
97583|NCT01987453|B2|Baseline|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
97584|NCT01987453|B1|Baseline|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
97585|NCT01987453|P3|Participant Flow|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
97586|NCT01987453|P2|Participant Flow|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
97587|NCT01987453|P1|Participant Flow|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior sofosbuvir (SOF) + ribavirin (RBV) ± pegylated interferon (Peg-IFN) regimen received ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
97588|NCT01987453|O3|Outcome|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
97589|NCT01987453|O2|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
97590|NCT01987453|O1|Outcome|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
97591|NCT01987453|O3|Outcome|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF + RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
97592|NCT01987453|O2|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
97593|NCT01987453|O1|Outcome|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
97594|NCT01987453|O3|Outcome|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF + RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
97595|NCT01987453|O2|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
97596|NCT01987453|O1|Outcome|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
97597|NCT01987453|O3|Outcome|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
97598|NCT01987453|O2|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
97599|NCT01987453|O1|Outcome|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
97600|NCT01987453|O3|Outcome|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF + RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
97601|NCT01987453|O2|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF± RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
99839|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
97602|NCT01987453|O1|Outcome|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
97603|NCT01987453|O3|Outcome|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
97604|NCT01987453|O2|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF ± RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
97605|NCT01987453|O1|Outcome|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
97606|NCT01987453|E3|Reported Event|LDV/SOF + RBV 24 Week (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
97607|NCT01987453|E2|Reported Event|LDV/SOF 24 Week (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
97608|NCT01987453|E1|Reported Event|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
97609|NCT01987349|B9|Baseline|Total|Total of all reporting groups
97610|NCT01987349|B8|Baseline|Group G: 70-100 yo Nontwins|Participants to receive Fluzone® (intramuscular)
97611|NCT01987349|B7|Baseline|Group F: 70-100 yo Identical Twins|Participants to receive Fluzone® (intramuscular)
97612|NCT01987349|B6|Baseline|Group E: Age 40-49 yo Fraternal Twins|Participants to receive FluMist® (intranasal)
97613|NCT01987349|B5|Baseline|Group D: Age 40-49 yo Identical Twins|Participants to receive FluMist® (intranasal)
97614|NCT01987349|B4|Baseline|Group C: Age 18-30 yo Fraternal Twins|Participants to receive FluMist® (intranasal)
97615|NCT01987349|B3|Baseline|Group B: Age 18-30 yo Identical Twins|Participants to receive FluMist® (intranasal)
97616|NCT01987349|B2|Baseline|Group A: Age 8-17 yo Identical Twins (FluMist)|Participants will be randomized to receive FluMist® (intranasal)
97617|NCT01987349|B1|Baseline|Group A: Age 8-17 yo Identical Twins (Fluzone)|Participants will be randomized to receive Fluzone® (intramuscular)
97618|NCT01987349|P8|Participant Flow|Group G: 70-100 yo Nontwins|Participants to receive Fluzone® (intramuscular)
97619|NCT01987349|P7|Participant Flow|Group F: 70-100 yo Identical Twins|Participants to receive Fluzone® (intramuscular)
97620|NCT01987349|P6|Participant Flow|Group E: Age 40-49 yo Fraternal Twins|Participants to receive FluMist® (intranasal)
97621|NCT01987349|P5|Participant Flow|Group D: Age 40-49 yo Identical Twins|Participants to receive FluMist® (intranasal)
97622|NCT01987349|P4|Participant Flow|Group C: Age 18-30 yo Fraternal Twins|Participants to receive FluMist® (intranasal)
97623|NCT01987349|P3|Participant Flow|Group B: Age 18-30 yo Identical Twins|Participants to receive FluMist® (intranasal)
97624|NCT01987349|P2|Participant Flow|Group A: Age 8-17yo Identical Twins|Participants will be randomized to receive FluMist® (intranasal)
97625|NCT01987349|P1|Participant Flow|Group A: Age 8-17 yo Identical Twins|Participants will be randomized to receive Fluzone® (intramuscular)
97626|NCT01987349|O8|Outcome|Group G: 70-100 yo Non-twins|"Participants to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
97627|NCT01987349|O7|Outcome|Group F: 70-100 yo Twins|"Participants to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
97628|NCT01987349|O6|Outcome|Group E: 40-49 yo Fraternal Twins|"Participants to receive FluMist® (intranasal)~FluMist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
97629|NCT01987349|O5|Outcome|Group D: 40-49 yo Identical Twins|"Participants to receive FluMist® (intranasal)~FluMist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
97630|NCT01987349|O4|Outcome|Group C: 18-30 yo Fraternal Twins|"Participants to receive FluMist® (intranasal)~FluMist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
97631|NCT01987349|O3|Outcome|Group B: 18-30 yo Identical Twins|"Participants to receive FluMist® (intranasal)~FluMist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
97632|NCT01987349|O2|Outcome|Group A: Age 8-17 yo Identical Twins (IN)|"Participants will be randomized to receive FluMist® (intranasal)~FluMist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
97633|NCT01987349|O1|Outcome|Group A: Age 8-17 yo Identical Twins (IM)|"Participants will be randomized to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
97634|NCT01987349|O8|Outcome|Group G: 70-100 yo Non-twins|"Participants to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
97635|NCT01987349|O7|Outcome|Group F: 70-100 yo Twins|"Participants to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
97636|NCT01987349|O6|Outcome|Group E: 40-49 yo Fraternal Twins|"Participants to receive Flumist® (intranasal)~Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
97637|NCT01987349|O5|Outcome|Group D: 40-49 yo Identical Twins|"Participants to receive Flumist® (intranasal)~Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
97638|NCT01987349|O4|Outcome|Group C: 18-30 yo Fraternal Twins|"Participants to receive Flumist® (intranasal)~Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
97639|NCT01987349|O3|Outcome|Group B: 18-30 yo Identical Twins|"Participants to receive FluMist® (intranasal)~FluMist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
97726|NCT01987219|P5|Participant Flow|Placebo; Albuterol; Ipratropium|Participants in this group received placebo followed by albuterol followed by ipratropium
97640|NCT01987349|O2|Outcome|Group A: Age 8-17 yo Identical Twins (IN)|"Participants will be randomized to receive FluMist® (intranasal~FluMist®: Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
97641|NCT01987349|O1|Outcome|Group A: Age 8-17 yo Identical Twins (IM)|"Participants will be randomized to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
97642|NCT01987349|E8|Reported Event|Group G: 70-100 yo Non-twins|"Participants to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
97643|NCT01987349|E7|Reported Event|Group F: 70-100 yo Twins|"Participants to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
97644|NCT01987349|E6|Reported Event|Group E: 40-49 yo Fraternal Twins|"Participants to receive Flumist® (intranasal)~Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
97645|NCT01987349|E5|Reported Event|Group D: 40-49 yo Identical Twins|"Participants to receive Flumist® (intranasal)~Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
97646|NCT01987349|E4|Reported Event|Group C: 18-30 yo Fraternal Twins|"Participants to receive Flumist® (intranasal)~Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
97647|NCT01987349|E3|Reported Event|Group B: 18-30 yo Identical Twin Pairs|"Participants to receive Flumist® (intranasal)~Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
97648|NCT01987349|E2|Reported Event|Group A: Age 8-17 yo Identical Twins (Flumist)|Participants will be randomized to receive Flumist® (intranasal)
97649|NCT01987349|E1|Reported Event|Group A: Age 8-17 yo Identical Twins (Fluzone)|Participants will be randomized to receive Fluzone® (intramuscular)
97650|NCT01987232|B6|Baseline|Total|Total of all reporting groups
97651|NCT01987232|B5|Baseline|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97652|NCT01987232|B4|Baseline|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97653|NCT01987232|B3|Baseline|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97654|NCT01987232|B2|Baseline|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97655|NCT01987232|B1|Baseline|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97656|NCT01987232|P5|Participant Flow|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97657|NCT01987232|P4|Participant Flow|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97658|NCT01987232|P3|Participant Flow|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97659|NCT01987232|P2|Participant Flow|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97660|NCT01987232|P1|Participant Flow|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target area under the curve (AUC) of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97661|NCT01987232|O6|Outcome|All Participants|Participants received carfilzomib on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97662|NCT01987232|O5|Outcome|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97663|NCT01987232|O4|Outcome|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97664|NCT01987232|O3|Outcome|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97665|NCT01987232|O2|Outcome|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97666|NCT01987232|O1|Outcome|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97667|NCT01987232|O6|Outcome|All Participants|Participants received carfilzomib on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target area AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97668|NCT01987232|O5|Outcome|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97669|NCT01987232|O4|Outcome|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97670|NCT01987232|O3|Outcome|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97671|NCT01987232|O2|Outcome|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97672|NCT01987232|O1|Outcome|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97673|NCT01987232|O6|Outcome|All Participants|Participants received carfilzomib on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97674|NCT01987232|O5|Outcome|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97675|NCT01987232|O4|Outcome|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97676|NCT01987232|O3|Outcome|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97677|NCT01987232|O2|Outcome|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97678|NCT01987232|O1|Outcome|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97679|NCT01987232|O6|Outcome|All Participants|Participants received carfilzomib on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97680|NCT01987232|O5|Outcome|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97681|NCT01987232|O4|Outcome|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97682|NCT01987232|O3|Outcome|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97683|NCT01987232|O2|Outcome|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97684|NCT01987232|O1|Outcome|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97685|NCT01987232|O6|Outcome|All Participants|Participants received carfilzomib on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97686|NCT01987232|O5|Outcome|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97687|NCT01987232|O4|Outcome|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97688|NCT01987232|O3|Outcome|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97689|NCT01987232|O2|Outcome|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97690|NCT01987232|O1|Outcome|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97691|NCT01987232|O6|Outcome|All Participants|Participants received carfilzomib on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97692|NCT01987232|O5|Outcome|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97693|NCT01987232|O4|Outcome|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97694|NCT01987232|O3|Outcome|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97695|NCT01987232|O2|Outcome|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97696|NCT01987232|O1|Outcome|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97697|NCT01987232|O6|Outcome|All Participants|Participants received carfilzomib on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97698|NCT01987232|O5|Outcome|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97699|NCT01987232|O4|Outcome|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97700|NCT01987232|O3|Outcome|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97701|NCT01987232|O2|Outcome|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97702|NCT01987232|O1|Outcome|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97703|NCT01987232|O5|Outcome|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97704|NCT01987232|O4|Outcome|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97727|NCT01987219|P4|Participant Flow|Placebo; Ipratropium; Albuterol|Participants in this group received placebo followed by ipratropium followed by albuterol
97728|NCT01987219|P3|Participant Flow|Albuterol; Ipratropium; Placebo|Participants in this group received albuterol followed by ipratropium followed by placebo
99840|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
97705|NCT01987232|O3|Outcome|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97706|NCT01987232|O2|Outcome|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97707|NCT01987232|O1|Outcome|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97708|NCT01987232|O5|Outcome|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97709|NCT01987232|O4|Outcome|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97710|NCT01987232|O3|Outcome|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97711|NCT01987232|O2|Outcome|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97712|NCT01987232|O1|Outcome|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97713|NCT01987232|E5|Reported Event|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97714|NCT01987232|E4|Reported Event|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97715|NCT01987232|E3|Reported Event|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97716|NCT01987232|E2|Reported Event|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97717|NCT01987232|E1|Reported Event|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
97718|NCT01987219|B7|Baseline|Total|Total of all reporting groups
97719|NCT01987219|B6|Baseline|Ipratropium; Placebo; Albuterol|
97720|NCT01987219|B5|Baseline|Placebo; Albuterol; Ipratropium|
97721|NCT01987219|B4|Baseline|Placebo; Ipratropium; Albuterol|
97722|NCT01987219|B3|Baseline|Albuterol; Ipratropium; Placebo|
97723|NCT01987219|B2|Baseline|Albuterol; Placebo; Ipratropium|
97724|NCT01987219|B1|Baseline|Ipratropium; Alubterol; Placebo|
97725|NCT01987219|P6|Participant Flow|Ipratropium; Placebo; Albuterol|Participants in this group received ipratropium followed by placebo followed by albuterol
99892|NCT01976104|B5|Baseline|Total|Total of all reporting groups
97729|NCT01987219|P2|Participant Flow|Albuterol; Placebo; Ipratropium|Participants in this group received albuterol followed by placebo followed by ipratropium
97730|NCT01987219|P1|Participant Flow|Ipratropium; Alubterol; Placebo|Participants in this group received ipratropium followed by albuterol followed by placebo
97731|NCT01987219|O3|Outcome|Placebo|"Placebo Saline solution 3 cc NA~placebo: Saline solution 3 cc NA"
97732|NCT01987219|O2|Outcome|Ipratropium-bromide (Atrovent ®)|"IpratroAnti-cholinergic(Atrovent ®) 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours.pium-bromide~Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours."
97733|NCT01987219|O1|Outcome|Albuterol-sulphate|"Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours~Albuterol-sulphate: Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours"
97734|NCT01987219|O3|Outcome|Placebo|"Placebo Saline solution 3 cc NA~placebo: Saline solution 3 cc NA"
97735|NCT01987219|O2|Outcome|Ipratropium-bromide (Atrovent ®)|"IpratroAnti-cholinergic(Atrovent ®) 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours.pium-bromide~Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours."
97736|NCT01987219|O1|Outcome|Albuterol-sulphate|"Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours~Albuterol-sulphate: Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours"
97737|NCT01987219|O3|Outcome|Placebo|"Placebo Saline solution 3 cc NA~placebo: Saline solution 3 cc NA"
97738|NCT01987219|O2|Outcome|Ipratropium-bromide (Atrovent ®)|"IpratroAnti-cholinergic(Atrovent ®) 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours.pium-bromide~Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours."
97739|NCT01987219|O1|Outcome|Albuterol-sulphate|"Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours~Albuterol-sulphate: Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours"
97740|NCT01987219|O3|Outcome|Placebo|"Placebo Saline solution 3 cc NA~placebo: Saline solution 3 cc NA"
97741|NCT01987219|O2|Outcome|Ipratropium-bromide (Atrovent ®)|"IpratroAnti-cholinergic(Atrovent ®) 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours.pium-bromide~Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours."
97742|NCT01987219|O1|Outcome|Albuterol-sulphate|"Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours~Albuterol-sulphate: Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours"
97743|NCT01987219|E3|Reported Event|Placebo|"Placebo Saline solution 3 cc NA~placebo: Saline solution 3 cc NA"
97744|NCT01987219|E2|Reported Event|Ipratropium-bromide (Atrovent ®)|"IpratroAnti-cholinergic(Atrovent ®) 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours.pium-bromide~Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours."
97745|NCT01987219|E1|Reported Event|Albuterol-sulphate|"Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours~Albuterol-sulphate: Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours"
97746|NCT01986985|B1|Baseline|Single Arm PET MRI|"single group evaluation of PET/ MR for diagnostic quality of image~PET/MRI system: Compared to PET CT"
97747|NCT01986985|P1|Participant Flow|Single Arm PET MRI|"single group evaluation of PET/ MR for diagnostic quality of image~PET/MRI system: Compared to PET CT"
97748|NCT01986985|O1|Outcome|Single Arm PET MRI|"single group evaluation of PET/ MR for diagnostic quality of image~PET/MRI system: Compared to PET CT"
97749|NCT01986985|E1|Reported Event|Single Arm PET MRI|"single group evaluation of PET/ MR for diagnostic quality of image~PET/MRI system: Compared to PET CT"
97750|NCT01986946|B3|Baseline|Total|Total of all reporting groups
97751|NCT01986946|B2|Baseline|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
97752|NCT01986946|B1|Baseline|Intravenous Opioids|"This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.~Dilaudid: Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid)."
97753|NCT01986946|P2|Participant Flow|Epidural Catheter|"The intervention to be tested in this study against standard intravenous opioids is infusion of local anesthetic and dilaudid via epidural catheter for post-operative pain control in patients undergoing lumbar spine fusion surgery.~Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery."
97754|NCT01986946|P1|Participant Flow|Intravenous Opioids|"This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.~Dilaudid: Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid)."
97755|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
97756|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
97887|NCT01986361|O2|Outcome|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
97757|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
97758|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
97759|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
97760|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
97761|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
97762|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
97763|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
97764|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
97765|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
97766|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
97767|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
97768|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
97769|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
97770|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
97771|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
97772|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
97773|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
97774|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
97775|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
97776|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
97777|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
97778|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
97779|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
97780|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
97781|NCT01986946|E2|Reported Event|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
97782|NCT01986946|E1|Reported Event|Intravenous Opioids|"This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.~Dilaudid: Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid)."
97783|NCT01986855|B4|Baseline|Total|Total of all reporting groups
97784|NCT01986855|B3|Baseline|Placebo|Placebo, oral, tablet, 5-mg or 5-mg and 10-mg tablet once daily for 52 weeks
97785|NCT01986855|B2|Baseline|Ertugliflozin 15 mg|Ertugliflozin, oral, 5-mg and 10-mg tablet once daily for 52 weeks
97786|NCT01986855|B1|Baseline|Ertugliflozin 5 mg|Ertugliflozin, oral, 5-mg tablet once daily for 52 weeks. Participants also received a 10-mg matching placebo tablet once daily for 52 weeks.
97787|NCT01986855|P3|Participant Flow|Placebo|Placebo, oral, tablet, 5-mg or 5-mg and 10-mg tablet once daily for 52 weeks
97788|NCT01986855|P2|Participant Flow|Ertugliflozin 15 mg|Ertugliflozin, oral, 5-mg and 10-mg tablet once daily for 52 weeks
97789|NCT01986855|P1|Participant Flow|Ertugliflozin 5 mg|Ertugliflozin, oral, 5-mg tablet once daily for 52 weeks. Participants also received a 10-mg matching placebo tablet once daily for 52 weeks.
97790|NCT01986855|O3|Outcome|Placebo|Placebo, oral, tablet, 5-mg or 5-mg and 10-mg tablet once daily for 52 weeks
97791|NCT01986855|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, oral, 5-mg and 10-mg tablet once daily for 52 weeks
97792|NCT01986855|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, oral, 5-mg tablet once daily for 52 weeks. Participants also received a 10-mg matching placebo tablet once daily for 52 weeks.
97793|NCT01986855|O3|Outcome|Placebo|Placebo, oral, tablet, 5-mg or 5-mg and 10-mg tablet once daily for 52 weeks
97794|NCT01986855|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, oral, 5-mg and 10-mg tablet once daily for 52 weeks
97795|NCT01986855|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, oral, 5-mg tablet once daily for 52 weeks. Participants also received a 10-mg matching placebo tablet once daily for 52 weeks.
97796|NCT01986855|O3|Outcome|Placebo|Placebo, oral, tablet, 5-mg or 5-mg and 10-mg tablet once daily for 52 weeks
97797|NCT01986855|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, oral, 5-mg and 10-mg tablet once daily for 52 weeks
97798|NCT01986855|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, oral, 5-mg tablet once daily for 52 weeks. Participants also received a 10-mg matching placebo tablet once daily for 52 weeks.
97799|NCT01986855|O3|Outcome|Placebo|Placebo, oral, tablet, 5-mg or 5-mg and 10-mg tablet once daily for 52 weeks
97800|NCT01986855|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, oral, 5-mg and 10-mg tablet once daily for 52 weeks
97801|NCT01986855|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, oral, 5-mg tablet once daily for 52 weeks. Participants also received a 10-mg matching placebo tablet once daily for 52 weeks.
97802|NCT01986855|O3|Outcome|Placebo|Placebo, oral, tablet, 5-mg or 5-mg and 10-mg tablet once daily for 52 weeks
97803|NCT01986855|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, oral, 5-mg and 10-mg tablet once daily for 52 weeks
97804|NCT01986855|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, oral, 5-mg tablet once daily for 52 weeks. Participants also received a 10-mg matching placebo tablet once daily for 52 weeks.
97805|NCT01986855|O3|Outcome|Placebo|Placebo, oral, tablet, 5-mg or 5-mg and 10-mg tablet once daily for 52 weeks
97806|NCT01986855|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, oral, 5-mg and 10-mg tablet once daily for 52 weeks
97807|NCT01986855|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, oral, 5-mg tablet once daily for 52 weeks. Participants also received a 10-mg matching placebo tablet once daily for 52 weeks.
97808|NCT01986855|O3|Outcome|Placebo|Placebo, oral, tablet, 5-mg or 5-mg and 10-mg tablet once daily for 52 weeks
97809|NCT01986855|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, oral, 5-mg and 10-mg tablet once daily for 52 weeks
97810|NCT01986855|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, oral, 5-mg tablet once daily for 52 weeks. Participants also received a 10-mg matching placebo tablet once daily for 52 weeks.
97811|NCT01986855|O3|Outcome|Placebo|Placebo, oral, tablet, 5-mg or 5-mg and 10-mg tablet once daily for 52 weeks
97812|NCT01986855|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, oral, 5-mg and 10-mg tablet once daily for 52 weeks
97813|NCT01986855|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, oral, 5-mg tablet once daily for 52 weeks. Participants also received a 10-mg matching placebo tablet once daily for 52 weeks.
97814|NCT01986855|E3|Reported Event|Ertugliflozin 15 mg|Ertugliflozin, oral, 5-mg and 10-mg tablet once daily for 52 weeks
97815|NCT01986855|E2|Reported Event|Ertugliflozin 5 mg|Ertugliflozin, oral, 5-mg tablet once daily for 52 weeks. Participants also received a 10-mg matching placebo tablet once daily for 52 weeks.
97816|NCT01986855|E1|Reported Event|Placebo|Placebo, oral, tablet, 5-mg or 5-mg and 10-mg tablet once daily for 52 weeks
97817|NCT01986790|B4|Baseline|Total|Total of all reporting groups
97818|NCT01986790|B3|Baseline|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.~Plain Language + Narratives"
97819|NCT01986790|B2|Baseline|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.~Plain Language + Visuals"
97820|NCT01986790|B1|Baseline|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.~Plain Language"
97888|NCT01986361|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
97821|NCT01986790|P3|Participant Flow|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.~Plain Language + Narratives"
97822|NCT01986790|P2|Participant Flow|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.~Plain Language + Visuals"
97823|NCT01986790|P1|Participant Flow|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.~Plain Language"
97824|NCT01986790|O3|Outcome|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.~Plain Language + Narratives"
97825|NCT01986790|O2|Outcome|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.~Plain Language + Visuals"
97826|NCT01986790|O1|Outcome|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.~Plain Language"
97827|NCT01986790|O3|Outcome|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.~Plain Language + Narratives"
97828|NCT01986790|O2|Outcome|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.~Plain Language + Visuals"
97829|NCT01986790|O1|Outcome|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.~Plain Language"
97830|NCT01986790|O3|Outcome|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.~Plain Language + Narratives"
97831|NCT01986790|O2|Outcome|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.~Plain Language + Visuals"
97832|NCT01986790|O1|Outcome|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.~Plain Language"
97833|NCT01986790|E3|Reported Event|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.~Plain Language + Narratives"
97834|NCT01986790|E2|Reported Event|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.~Plain Language + Visuals"
97835|NCT01986790|E1|Reported Event|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.~Plain Language"
97836|NCT01986751|B3|Baseline|Total|Total of all reporting groups
97837|NCT01986751|B2|Baseline|Ropivacaine|"Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine~ropivacaine"
97838|NCT01986751|B1|Baseline|Clonidine and Ropivacaine|"A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).~Clonidine~ropivacaine"
97839|NCT01986751|P2|Participant Flow|Ropivacaine|"Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine~ropivacaine"
97840|NCT01986751|P1|Participant Flow|Clonidine and Ropivacaine|"A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).~Clonidine~ropivacaine"
97841|NCT01986751|O2|Outcome|Ropivacaine|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
97842|NCT01986751|O1|Outcome|Clonidine and Ropivacaine|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
97843|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
97844|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
97845|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
97846|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
97847|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
97848|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
97849|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
97850|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
97851|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
97852|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
97853|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
97854|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
97855|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
97856|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
97857|NCT01986751|E2|Reported Event|Ropivacaine (Control)|Standard saphenous nerve block (adductor canal approach) will be performed using 20 ml of 0.5% ropivacaine
97858|NCT01986751|E1|Reported Event|Clonidine and Ropivacaine (Study Group)|A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).
97859|NCT01986686|B3|Baseline|Total|Total of all reporting groups
97860|NCT01986686|B2|Baseline|Surgery|"The surgery group will be offered colon resection.~Colon resection: Elective robotic/laparoscopic/open colon resection for diverticular disease."
97861|NCT01986686|B1|Baseline|Observational|The observation group will be followed clinically with no further intervention until the primary endpoint is reached.
97862|NCT01986686|P2|Participant Flow|Surgery|"The surgery group will be offered colon resection.~Colon resection: Elective robotic/laparoscopic/open colon resection for diverticular disease."
97863|NCT01986686|P1|Participant Flow|Observational|The observation group will be followed clinically with no further intervention until the primary endpoint is reached.
97864|NCT01986686|O2|Outcome|Surgery|"The surgery group will be offered colon resection.~Colon resection: Elective robotic/laparoscopic/open colon resection for diverticular disease."
97865|NCT01986686|O1|Outcome|Observational|The observation group will be followed clinically with no further intervention until the primary endpoint is reached.
97866|NCT01986686|E2|Reported Event|Surgery|"The surgery group will be offered colon resection.~Colon resection: Elective robotic/laparoscopic/open colon resection for diverticular disease."
97867|NCT01986686|E1|Reported Event|Observational|The observation group will be followed clinically with no further intervention until the primary endpoint is reached.
97868|NCT01986361|B3|Baseline|Total|Total of all reporting groups
97869|NCT01986361|B2|Baseline|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
97870|NCT01986361|B1|Baseline|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
97871|NCT01986361|P2|Participant Flow|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
97872|NCT01986361|P1|Participant Flow|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
97873|NCT01986361|O2|Outcome|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
97874|NCT01986361|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
97875|NCT01986361|O2|Outcome|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
97876|NCT01986361|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
97877|NCT01986361|O2|Outcome|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
97878|NCT01986361|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
97879|NCT01986361|O2|Outcome|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
97880|NCT01986361|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
97881|NCT01986361|O2|Outcome|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
97882|NCT01986361|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
97883|NCT01986361|O2|Outcome|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
97884|NCT01986361|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
97885|NCT01986361|O2|Outcome|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
97886|NCT01986361|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
97891|NCT01986361|E2|Reported Event|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
97892|NCT01986361|E1|Reported Event|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
97893|NCT01986231|B1|Baseline|Open-Label Glucagon|"Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.~Glucagon: Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35."
97894|NCT01986231|P1|Participant Flow|Open-Label Glucagon|"Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.~Glucagon: Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35."
97895|NCT01986231|O1|Outcome|Open-Label Glucagon|"Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.~Glucagon: Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35."
97896|NCT01986231|O1|Outcome|Open-Label Glucagon|"Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.~Glucagon: Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35."
97897|NCT01986231|E1|Reported Event|Open-Label Glucagon|"Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.~Glucagon: Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35."
97898|NCT01986062|B3|Baseline|Total|Total of all reporting groups
97899|NCT01986062|B2|Baseline|Placebo (1 Week) Then AR11 (1 Week) - Double Blind|Placebo, administered orally, BID for one week (crossover to AR11 administration week 2)
97900|NCT01986062|B1|Baseline|AR11 (1 Week) Then Placebo (1 Week) - Double Blind|AR11, administered orally, BID for one week (crossover to placebo administration week 2)
97901|NCT01986062|P2|Participant Flow|Placebo (1 Week) Then AR11 (1 Week) - Double Blind|Placebo, administered orally, BID, for one week (crossover to AR11administration week 2)
97902|NCT01986062|P1|Participant Flow|AR11 (1 Week) Then Placebo (1 Week) - Double Blind|AR11, administered orally, BID, for one week (crossover to placebo administration week 2)
97903|NCT01986062|O2|Outcome|Placebo|Placebo, administered orally, BID
97904|NCT01986062|O1|Outcome|AR11 (Amphetamine Sulfate)|AR11, administered orally, BID, 10-40 mg/day
97905|NCT01986062|O2|Outcome|Placebo|Placebo, administered orally, BID
97906|NCT01986062|O1|Outcome|AR11 (Amphetamine Sulfate)|AR11, administered orally, BID, 10-40 mg/day
97907|NCT01986062|O2|Outcome|Placebo|Placebo, administered orally, BID
97908|NCT01986062|O1|Outcome|AR11 (Amphetamine Sulfate)|AR11, administered orally, BID, 10-40 mg/day
97909|NCT01986062|O2|Outcome|Placebo|Placebo, administered orally, BID
97910|NCT01986062|O1|Outcome|AR11 (Amphetamine Sulfate)|AR11, administered orally, BID, 10-40 mg/day
97911|NCT01986062|O2|Outcome|Placebo|Placebo, administered orally, BID
97912|NCT01986062|O1|Outcome|AR11 (Amphetamine Sulfate)|AR11, administered orally, BID, 10-40 mg/day
97913|NCT01986062|O2|Outcome|Placebo|Placebo, administered orally, BID
97914|NCT01986062|O1|Outcome|AR11 (Amphetamine Sulfate)|AR11, administered orally, BID, 10-40 mg/day
97915|NCT01986062|E2|Reported Event|Placebo|Placebo, administered orally, BID for one week
97916|NCT01986062|E1|Reported Event|AR11|AR11, administered orally, BID for one week
97917|NCT01985685|B3|Baseline|Total|Total of all reporting groups
97918|NCT01985685|B2|Baseline|Placebo|"50ml intravenous 5% dextrose, single dose~Thiamine: 200 mg IV thiamine"
97919|NCT01985685|B1|Baseline|Thiamine|"200mg intravenous thiamine in 50ml 5% dextrose, single dose~Thiamine: 200 mg IV thiamine"
97920|NCT01985685|P2|Participant Flow|Placebo|"50ml intravenous 5% dextrose, single dose~Thiamine: 200 mg IV thiamine"
97921|NCT01985685|P1|Participant Flow|Thiamine|"200mg intravenous thiamine in 50ml 5% dextrose, single dose~Thiamine: 200 mg IV thiamine"
97922|NCT01985685|O2|Outcome|Placebo|"50ml intravenous 5% dextrose, single dose~Thiamine: 200 mg IV thiamine"
97923|NCT01985685|O1|Outcome|Thiamine|"200mg intravenous thiamine in 50ml 5% dextrose, single dose~Thiamine: 200 mg IV thiamine"
97924|NCT01985685|O2|Outcome|Placebo|"50ml intravenous 5% dextrose, single dose~Thiamine: 200 mg IV thiamine"
97925|NCT01985685|O1|Outcome|Thiamine|"200mg intravenous thiamine in 50ml 5% dextrose, single dose~Thiamine: 200 mg IV thiamine"
97926|NCT01985685|O2|Outcome|Placebo|"50ml intravenous 5% dextrose, single dose~Thiamine: 200 mg IV thiamine"
97927|NCT01985685|O1|Outcome|Thiamine|"200mg intravenous thiamine in 50ml 5% dextrose, single dose~Thiamine: 200 mg IV thiamine"
97928|NCT01985685|E2|Reported Event|Placebo|"50ml intravenous 5% dextrose, single dose~Thiamine: 200 mg IV thiamine"
97929|NCT01985685|E1|Reported Event|Thiamine|"200mg intravenous thiamine in 50ml 5% dextrose, single dose~Thiamine: 200 mg IV thiamine"
97930|NCT01985581|B3|Baseline|Total|Total of all reporting groups
97931|NCT01985581|B2|Baseline|GXR First Then PLB|subjects received GXR in first arm of study and PLB in second arm subject continued to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine)
97932|NCT01985581|B1|Baseline|PLB First Then GXR|subjects received PLB in first arm of study and GXR in second arm. subject continued to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine)
97933|NCT01985581|P2|Participant Flow|GXR First Then Placebo|patient will continue to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine) and GXR for the first intervention period and placebo for the second intervention period (after a washout period). GXR dose was optimized to between 1 and 4mg.
97934|NCT01985581|P1|Participant Flow|Placebo First Then GXR|patient will continue to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine) and placebo for the first intervention period and GXR for the second intervention period (after a washout period). GXR dose was optimized to between 1 and 4mg.
97935|NCT01985581|O2|Outcome|GXR and Stimulant|subjects who continued to take usual stimulant dosage and took GXR (optimized dose 1-4 mg)
97936|NCT01985581|O1|Outcome|Placebo and Stimulant|subjects who continued to take usual stimulant dosage and took placebo
97937|NCT01985581|O2|Outcome|GXR and Stimulant|subjects who continued to take usual stimulant dosage and took GXR at optimized dose of 1-4 mg
97938|NCT01985581|O1|Outcome|Placebo and Stimulant|subjects who continued to take usual stimulant dosage and took placebo
97939|NCT01985581|O2|Outcome|GXR and Stimulant|The child's quality of life as assessed by the parent was measured in subjects taking usual stimulant and GXR (optimized dose 1-4 mg)
97940|NCT01985581|O1|Outcome|Placebo and Stimulant|The child's quality of life as assessed by the parent was measured in subjects taking usual stimulant and placebo
97941|NCT01985581|O2|Outcome|Stimulant and Guanfancine Extended Release|"patient will continue to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine) and also receive guanfacine extended release at a individually optimized dosage of 1-4 mg.~Guanfacine extended release"
97942|NCT01985581|O1|Outcome|Stimulant & Placebo|"patient will continue to take stable dosage of usual stimulant(Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine)therapy plus placebo~Placebo"
97943|NCT01985581|O2|Outcome|GXR and Stimulant|Patients continued to take usual dose stimulant and optimized dose (1-4mg) of GXR
97944|NCT01985581|O1|Outcome|Placebo and Stimulant|subjects continued to take usual dose stimulant and took placebo
97945|NCT01985581|O2|Outcome|GXR and Stimulant|The quality of life was measured in those patients taking GXR along with their usual stimulant therapy
97946|NCT01985581|O1|Outcome|Placebo and Stimulant|The quality of life was measured in those patients taking placebo along with their usual stimulant therapy
97947|NCT01985581|O2|Outcome|GXR and Stimulant|Subjects received GXR (1-4 mg as optimized dosage) in addition to usual stimulant therapy
97948|NCT01985581|O1|Outcome|Placebo and Stimulant|Subjects received placebo and usual stimulant therapy
97949|NCT01985581|E2|Reported Event|Stimulant and PLB|adverse event frequency in those taking stimulant + PLB
97950|NCT01985581|E1|Reported Event|Stimulant and GXR|adverse event frequency in those taking stimulant + GXR
97951|NCT01985425|B3|Baseline|Total|Total of all reporting groups
97952|NCT01985425|B2|Baseline|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
97953|NCT01985425|B1|Baseline|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
97954|NCT01985425|P2|Participant Flow|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
97955|NCT01985425|P1|Participant Flow|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
97956|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
97957|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
98028|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
97958|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
97959|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
97960|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
97961|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
97962|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
97963|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
97964|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
97965|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
97966|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
97967|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
97968|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
97969|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
97970|NCT01985425|E2|Reported Event|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
97971|NCT01985425|E1|Reported Event|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
97972|NCT01985321|B3|Baseline|Total|Total of all reporting groups
97973|NCT01985321|B2|Baseline|Ethanol|36 applications over a 96 hour period
97974|NCT01985321|B1|Baseline|Merlin - Ethanol/Glycolic Acid Solution|"36 applications over a 96 hour period~ethanol/glycolic acid solution: ethanol/glycolic acid solution"
97975|NCT01985321|P2|Participant Flow|Ethanol|36 applications over a 96 hour period
97976|NCT01985321|P1|Participant Flow|Merlin - Ethanol/Glycolic Acid Solution|"36 applications over a 96 hour period~ethanol/glycolic acid solution: ethanol/glycolic acid solution"
97977|NCT01985321|O2|Outcome|Ethanol|36 applications over a 96 hour period
97978|NCT01985321|O1|Outcome|Merlin - Ethanol/Glycolic Acid Solution|"36 applications over a 96 hour period~ethanol/glycolic acid solution: ethanol/glycolic acid solution"
97979|NCT01985321|O2|Outcome|Ethanol|36 applications over a 96 hour period
97980|NCT01985321|O1|Outcome|Merlin - Ethanol/Glycolic Acid Solution|"36 applications over a 96 hour period~ethanol/glycolic acid solution: ethanol/glycolic acid solution"
97981|NCT01985321|E2|Reported Event|Ethanol|36 applications over a 96 hour period
97982|NCT01985321|E1|Reported Event|Merlin - Ethanol/Glycolic Acid Solution|"36 applications over a 96 hour period~ethanol/glycolic acid solution: ethanol/glycolic acid solution"
97983|NCT01985126|B3|Baseline|Total|Total of all reporting groups
97984|NCT01985126|B2|Baseline|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
98029|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
97985|NCT01985126|B1|Baseline|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
97986|NCT01985126|P2|Participant Flow|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
97987|NCT01985126|P1|Participant Flow|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
97988|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
97989|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
97990|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
97991|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
97992|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
97993|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
97994|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
97995|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
97996|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
97997|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
97998|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
97999|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
98000|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
98001|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
98002|NCT01985126|E2|Reported Event|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
98003|NCT01985126|E1|Reported Event|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
98004|NCT01984892|B1|Baseline|Participants With Stage 4 Cancer|"Enrolled patients received two cycles of Poly-ICLC treatment. Each priming (intratumoral injections - IT) and boosting (intramuscular injections - IM) treatment course will constitute one cycle.~Poly-ICLC: Cycle 1-Weeks 1 and 2: 1mg Poly-ICLC intratumoral (IT) injections (t=6) into same lesion over 2 weeks.~Weeks 3-9: 1mg Poly-ICLC 2x/week intramuscularly (IM) into thighs or upper arms.~Week 10: No treatment. CT scan of chest, abdomen, pelvis and extremities or neck; possible MRI brain scan.~Cycle 2-Weeks 11 and 12: 1mg Poly-ICLC IT injections (t=6) into same lesion over 2 weeks.~Weeks 13-19 - 1mg Poly-ICLC 2x/weekly IM in thighs or upper arms. Weeks 20-26: no treatment. Week 26, evaluate response in absence of inflammation.~Maintenance - Weeks 27-36: For patients with stable disease or response; IM poly-ICLC injections; evaluation of clinical and immune response. Week 38 repeat tumor assessment, optional biopsy"
98005|NCT01984892|P1|Participant Flow|IT and IM Injections Poly-ICLC|"Enrolled patients received two cycles of Poly-ICLC treatment. Each priming (intratumoral injections - IT) and boosting (intramuscular injections - IM) treatment course will constitute one cycle.~Poly-ICLC: Cycle 1-Weeks 1 and 2: 1mg Poly-ICLC intratumoral (IT) injections (t=6) into same lesion over 2 weeks.~Weeks 3-9: 1mg Poly-ICLC 2x/week intramuscularly (IM) into thighs or upper arms.~Week 10: No treatment. CT scan of chest, abdomen, pelvis and extremities or neck; possible MRI brain scan.~Cycle 2-Weeks 11 and 12: 1mg Poly-ICLC IT injections (t=6) into same lesion over 2 weeks.~Weeks 13-19 - 1mg Poly-ICLC 2x/weekly IM in thighs or upper arms. Weeks 20-26: no treatment. Week 26, evaluate response in absence of inflammation.~Maintenance - Weeks 27-36: For patients with stable disease or response; IM poly-ICLC injections; evaluation of clinical and immune response. Week 38 repeat tumor assessment, optional biopsy"
98030|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98031|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98032|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98033|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
98006|NCT01984892|O1|Outcome|Participants With Stage 4 Cancer|"Enrolled patients received two cycles of Poly-ICLC treatment. Each priming (intratumoral injections - IT) and boosting (intramuscular injections - IM) treatment course will constitute one cycle.~Poly-ICLC: Cycle 1-Weeks 1 and 2: 1mg Poly-ICLC intratumoral (IT) injections (t=6) into same lesion over 2 weeks.~Weeks 3-9: 1mg Poly-ICLC 2x/week intramuscularly (IM) into thighs or upper arms.~Week 10: No treatment. CT scan of chest, abdomen, pelvis and extremities or neck; possible MRI brain scan.~Cycle 2-Weeks 11 and 12: 1mg Poly-ICLC IT injections (t=6) into same lesion over 2 weeks.~Weeks 13-19 - 1mg Poly-ICLC 2x/weekly IM in thighs or upper arms. Weeks 20-26: no treatment. Week 26, evaluate response in absence of inflammation.~Maintenance - Weeks 27-36: For patients with stable disease or response; IM poly-ICLC injections; evaluation of clinical and immune response. Week 38 repeat tumor assessment, optional biopsy"
98007|NCT01984892|O1|Outcome|Participants With Stage 4 Cancer|"Enrolled patients received two cycles of Poly-ICLC treatment. Each priming (intratumoral injections - IT) and boosting (intramuscular injections - IM) treatment course will constitute one cycle.~Poly-ICLC: Cycle 1-Weeks 1 and 2: 1mg Poly-ICLC intratumoral (IT) injections (t=6) into same lesion over 2 weeks.~Weeks 3-9: 1mg Poly-ICLC 2x/week intramuscularly (IM) into thighs or upper arms.~Week 10: No treatment. CT scan of chest, abdomen, pelvis and extremities or neck; possible MRI brain scan.~Cycle 2-Weeks 11 and 12: 1mg Poly-ICLC IT injections (t=6) into same lesion over 2 weeks.~Weeks 13-19 - 1mg Poly-ICLC 2x/weekly IM in thighs or upper arms. Weeks 20-26: no treatment. Week 26, evaluate response in absence of inflammation.~Maintenance - Weeks 27-36: For patients with stable disease or response; IM poly-ICLC injections; evaluation of clinical and immune response. Week 38 repeat tumor assessment, optional biopsy"
98008|NCT01984892|O1|Outcome|Participants With Stage 4 Cancer|"Enrolled patients received two cycles of Poly-ICLC treatment. Each priming (intratumoral injections - IT) and boosting (intramuscular injections - IM) treatment course will constitute one cycle.~Poly-ICLC: Cycle 1-Weeks 1 and 2: 1mg Poly-ICLC intratumoral (IT) injections (t=6) into same lesion over 2 weeks.~Weeks 3-9: 1mg Poly-ICLC 2x/week intramuscularly (IM) into thighs or upper arms.~Week 10: No treatment. CT scan of chest, abdomen, pelvis and extremities or neck; possible MRI brain scan.~Cycle 2-Weeks 11 and 12: 1mg Poly-ICLC IT injections (t=6) into same lesion over 2 weeks.~Weeks 13-19 - 1mg Poly-ICLC 2x/weekly IM in thighs or upper arms. Weeks 20-26: no treatment. Week 26, evaluate response in absence of inflammation.~Maintenance - Weeks 27-36: For patients with stable disease or response; IM poly-ICLC injections; evaluation of clinical and immune response. Week 38 repeat tumor assessment, optional biopsy"
98009|NCT01984892|E1|Reported Event|Participants With Stage 4 Cancer|"Enrolled patients received two cycles of Poly-ICLC treatment. Each priming (intratumoral injections - IT) and boosting (intramuscular injections - IM) treatment course will constitute one cycle.~Poly-ICLC: Cycle 1-Weeks 1 and 2: 1mg Poly-ICLC intratumoral (IT) injections (t=6) into same lesion over 2 weeks.~Weeks 3-9: 1mg Poly-ICLC 2x/week intramuscularly (IM) into thighs or upper arms.~Week 10: No treatment. CT scan of chest, abdomen, pelvis and extremities or neck; possible MRI brain scan.~Cycle 2-Weeks 11 and 12: 1mg Poly-ICLC IT injections (t=6) into same lesion over 2 weeks.~Weeks 13-19 - 1mg Poly-ICLC 2x/weekly IM in thighs or upper arms. Weeks 20-26: no treatment. Week 26, evaluate response in absence of inflammation.~Maintenance - Weeks 27-36: For patients with stable disease or response; IM poly-ICLC injections; evaluation of clinical and immune response. Week 38 repeat tumor assessment, optional biopsy"
98010|NCT01984697|B6|Baseline|Total|Total of all reporting groups
98011|NCT01984697|B5|Baseline|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98012|NCT01984697|B4|Baseline|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98013|NCT01984697|B3|Baseline|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
98014|NCT01984697|B2|Baseline|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98015|NCT01984697|B1|Baseline|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98016|NCT01984697|P5|Participant Flow|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98017|NCT01984697|P4|Participant Flow|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98018|NCT01984697|P3|Participant Flow|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
98019|NCT01984697|P2|Participant Flow|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98020|NCT01984697|P1|Participant Flow|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98021|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98022|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98023|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
98024|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98025|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98026|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98027|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98207|NCT01984294|O2|Outcome|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
98034|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98035|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98036|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98037|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98038|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
98039|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98040|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98041|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98042|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98043|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
98044|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98045|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98046|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98047|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98048|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
98049|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98050|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98051|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98052|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98053|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
98054|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98055|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98056|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98057|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98058|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
98059|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98060|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98061|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98062|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98063|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
98064|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98065|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98066|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98067|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98068|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
98069|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98070|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98071|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98072|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98073|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
98074|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98075|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98076|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98077|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98078|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
98079|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98080|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98081|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98082|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98083|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
98084|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98085|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98086|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98087|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98088|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
98089|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98090|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98091|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98092|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98093|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
98094|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98095|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98096|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98097|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98098|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
98099|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98100|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98101|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98102|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98103|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
98104|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98105|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98106|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98107|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98108|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
98109|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98110|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98111|NCT01984697|E5|Reported Event|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98112|NCT01984697|E4|Reported Event|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
98113|NCT01984697|E3|Reported Event|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
98114|NCT01984697|E2|Reported Event|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98115|NCT01984697|E1|Reported Event|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
98116|NCT01984684|B3|Baseline|Total|Total of all reporting groups
98117|NCT01984684|B2|Baseline|Vancomycin Plus Aztreonam|Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 up to a maximum of 28 doses total
98118|NCT01984684|B1|Baseline|Delafloxacin|300mg iv Q12H for 6 doses, 450mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total
98119|NCT01984684|P2|Participant Flow|Vancomycin Plus Aztreonam|Vancomycin 15 mg/kg IV plus two grams Aztreonam every 12 hours for a minimum of 10 up to a maximum of 28 doses total
98120|NCT01984684|P1|Participant Flow|Delafloxacin|300 mg IV Q12H for 6 doses, 450 mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total
98121|NCT01984684|O2|Outcome|Vancomycin Plus Aztreonam|Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 up to a maximum of 28 doses total
98122|NCT01984684|O1|Outcome|Delafloxacin|300mg iv Q12H for 6 doses, 450mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total
98123|NCT01984684|O2|Outcome|Vancomycin Plus Aztreonam|Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 up to a maximum of 28 doses total
98124|NCT01984684|O1|Outcome|Delafloxacin|300mg iv Q12H for 6 doses, 450mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total
98125|NCT01984684|O2|Outcome|Vancomycin Plus Aztreonam|Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 up to a maximum of 28 doses total
98126|NCT01984684|O1|Outcome|Delafloxacin|300mg iv Q12H for 6 doses, 450mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total
98127|NCT01984684|E2|Reported Event|Vancomycin Plus Aztreonam|Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 up to a maximum of 28 doses total
98128|NCT01984684|E1|Reported Event|Delafloxacin|300mg iv Q12H for 6 doses, 450mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total
98129|NCT01984515|B1|Baseline|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care~Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
98130|NCT01984515|P1|Participant Flow|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care~Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
98131|NCT01984515|O1|Outcome|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care~Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
98132|NCT01984515|O1|Outcome|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care~Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
98165|NCT01984424|O1|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98396|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
98133|NCT01984515|O1|Outcome|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care~Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
98134|NCT01984515|E1|Reported Event|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care~Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
98135|NCT01984424|B3|Baseline|Total|Total of all reporting groups
98136|NCT01984424|B2|Baseline|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98137|NCT01984424|B1|Baseline|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98138|NCT01984424|P2|Participant Flow|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98139|NCT01984424|P1|Participant Flow|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98140|NCT01984424|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98141|NCT01984424|O1|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98142|NCT01984424|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98143|NCT01984424|O1|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98144|NCT01984424|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98145|NCT01984424|O1|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98146|NCT01984424|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98147|NCT01984424|O1|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98148|NCT01984424|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98149|NCT01984424|O1|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98150|NCT01984424|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98151|NCT01984424|O1|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98152|NCT01984424|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98153|NCT01984424|O1|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98154|NCT01984424|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98155|NCT01984424|O1|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98156|NCT01984424|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98157|NCT01984424|O1|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98158|NCT01984424|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98159|NCT01984424|O1|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98160|NCT01984424|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98161|NCT01984424|O1|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98162|NCT01984424|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98163|NCT01984424|O1|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98164|NCT01984424|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98166|NCT01984424|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98167|NCT01984424|O1|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98168|NCT01984424|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98169|NCT01984424|O1|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98170|NCT01984424|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98171|NCT01984424|O1|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98172|NCT01984424|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98173|NCT01984424|O1|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98174|NCT01984424|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98175|NCT01984424|O1|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98176|NCT01984424|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98177|NCT01984424|O1|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98178|NCT01984424|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98179|NCT01984424|O1|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98180|NCT01984424|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98181|NCT01984424|O1|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98182|NCT01984424|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98183|NCT01984424|O1|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98184|NCT01984424|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98185|NCT01984424|O1|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98186|NCT01984424|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98187|NCT01984424|O1|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98188|NCT01984424|E2|Reported Event|Ezetimibe|Participants received 10 mg ezetimibe orally only a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
98189|NCT01984424|E1|Reported Event|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
98190|NCT01984294|B4|Baseline|Total|Total of all reporting groups
98191|NCT01984294|B3|Baseline|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
98192|NCT01984294|B2|Baseline|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
98193|NCT01984294|B1|Baseline|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
98194|NCT01984294|P3|Participant Flow|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
98195|NCT01984294|P2|Participant Flow|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
98196|NCT01984294|P1|Participant Flow|LDV/SOF+RBV|Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg fixed-dose combination (FDC) tablet once daily plus ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
98197|NCT01984294|O3|Outcome|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
98198|NCT01984294|O2|Outcome|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
98199|NCT01984294|O1|Outcome|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
98200|NCT01984294|O3|Outcome|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
98201|NCT01984294|O2|Outcome|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
98202|NCT01984294|O1|Outcome|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
98203|NCT01984294|O3|Outcome|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
98204|NCT01984294|O2|Outcome|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
98205|NCT01984294|O1|Outcome|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
98206|NCT01984294|O3|Outcome|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
98208|NCT01984294|O1|Outcome|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
98209|NCT01984294|O3|Outcome|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
98210|NCT01984294|O2|Outcome|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
98211|NCT01984294|O1|Outcome|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
98212|NCT01984294|E3|Reported Event|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
98213|NCT01984294|E2|Reported Event|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
98214|NCT01984294|E1|Reported Event|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
98215|NCT01984242|B4|Baseline|Total|Total of all reporting groups
98216|NCT01984242|B3|Baseline|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98217|NCT01984242|B2|Baseline|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98218|NCT01984242|B1|Baseline|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98219|NCT01984242|P3|Participant Flow|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98220|NCT01984242|P2|Participant Flow|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98221|NCT01984242|P1|Participant Flow|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98222|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98223|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98224|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98225|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98226|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98227|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98228|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98229|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98230|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98231|NCT01984242|O3|Outcome|Sunitinib (Crossover)|Among the participants assigned to sunitinib initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
98532|NCT01983111|O1|Outcome|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
98232|NCT01984242|O2|Outcome|Atezolizumab (Crossover)|Among the participants assigned to atezolizumab initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
98233|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98234|NCT01984242|O3|Outcome|Sunitinib (Crossover)|Among the participants assigned to sunitinib initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
98235|NCT01984242|O2|Outcome|Atezolizumab (Crossover)|Among the participants assigned to atezolizumab initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
98236|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98237|NCT01984242|O4|Outcome|Sunitinib (Crossover)|Among the participants assigned to sunitinib initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
98238|NCT01984242|O3|Outcome|Atezolizumab (Crossover)|Among the participants assigned to atezolizumab initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
98239|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98240|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98241|NCT01984242|O4|Outcome|Sunitinib (Crossover)|Among the participants assigned to sunitinib initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
98242|NCT01984242|O3|Outcome|Atezolizumab (Crossover)|Among the participants assigned to atezolizumab initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
98243|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98244|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98245|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98246|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98247|NCT01984242|O2|Outcome|Sunitinib (Crossover)|Among the participants assigned to sunitinib initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
98248|NCT01984242|O1|Outcome|Atezolizumab (Crossover)|Among the participants assigned to atezolizumab initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
98393|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
98249|NCT01984242|O2|Outcome|Sunitinib (Crossover)|Among the participants assigned to sunitinib initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
98250|NCT01984242|O1|Outcome|Atezolizumab (Crossover)|Among the participants assigned to atezolizumab initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
98251|NCT01984242|O2|Outcome|Sunitinib (Crossover)|Among the participants assigned to sunitinib initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
98252|NCT01984242|O1|Outcome|Atezolizumab (Crossover)|Among the participants assigned to atezolizumab initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
98253|NCT01984242|O2|Outcome|Sunitinib (Crossover)|Among the participants assigned to sunitinib initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
98254|NCT01984242|O1|Outcome|Atezolizumab (Crossover)|Among the participants assigned to atezolizumab initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
98255|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98256|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98257|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98258|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98259|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98260|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98261|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98262|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98263|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98264|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98265|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98266|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98267|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98268|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98269|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98270|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98271|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98272|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98273|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98274|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98275|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98276|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98277|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98278|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98279|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98280|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98281|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98282|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98283|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98284|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98285|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98286|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98287|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98288|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98289|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98290|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98291|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98292|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98293|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98294|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98295|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98296|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98297|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98298|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98299|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98300|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98301|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98302|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98303|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98304|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98305|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98306|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98394|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
98307|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98308|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98309|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98310|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98311|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98312|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98313|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98314|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98315|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98316|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98317|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98318|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98319|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98320|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98321|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98322|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98323|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98324|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98325|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98326|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98864|NCT01980940|O4|Outcome|ETOR 150 PG (Pt 1)|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
98327|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98328|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98329|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98330|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98331|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98332|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98333|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98334|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98335|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98336|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98337|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98338|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98339|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98340|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98341|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98342|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98343|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98344|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98345|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98346|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98347|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98348|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98349|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98350|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98351|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98352|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98353|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98354|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98355|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98356|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98357|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98358|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98359|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98360|NCT01984242|O3|Outcome|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98361|NCT01984242|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98362|NCT01984242|O1|Outcome|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98363|NCT01984242|E5|Reported Event|Sunitinib (Crossover)|Among the participants assigned to sunitinib initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
98364|NCT01984242|E4|Reported Event|Atezolizumab (Crossover)|Among the participants assigned to atezolizumab initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
98365|NCT01984242|E3|Reported Event|Sunitinib|Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98395|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
98366|NCT01984242|E2|Reported Event|Atezolizumab|Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
98367|NCT01984242|E1|Reported Event|Atezolizumab and Bevacizumab|Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
98368|NCT01984229|B3|Baseline|Total|Total of all reporting groups
98369|NCT01984229|B2|Baseline|Cohort B:Alectinib 300mg, Posaconazole, Alectinib+Posaconazole|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 21). Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal. The follow-up assessments occurred within 10 to 14 days after the last dose of posaconazole.
98370|NCT01984229|B1|Baseline|Cohort A: Alectinib 40mg, Posaconazole, Alectinib+Posaconazole|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 18). Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal. The follow-up assessments occurred within 10 to 14 days after the last dose of posaconazole.
98371|NCT01984229|P2|Participant Flow|Cohort B:Alectinib 300mg, Posaconazole, Alectinib+Posaconazole|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 21). Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal. The follow-up assessments occurred within 10 to 14 days after the last dose of posaconazole.
98372|NCT01984229|P1|Participant Flow|Cohort A: Alectinib 40mg, Posaconazole, Alectinib+Posaconazole|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 18). Alectinib was administered as a 40 milligrams (mg) single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg twice daily (BID) oral dose after a high-fat meal. The follow-up assessments occurred within 10 to 14 days after the last dose of posaconazole.
98373|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
98374|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
98375|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
98376|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
98377|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
98378|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
98379|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
98380|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
98381|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
98382|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
98383|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
98384|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
98385|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
98386|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
98387|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
98388|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
98389|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
98390|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
98391|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
98392|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
98397|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
98398|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
98399|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
98400|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
98401|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
98402|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
98403|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
98404|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
98405|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
98406|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
98407|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
98408|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
98409|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
98410|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
98411|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
98412|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
98413|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
98414|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
98415|NCT01984229|E6|Reported Event|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
98416|NCT01984229|E5|Reported Event|Cohort B: Posaconazole (Period 2)|Posaconazole was administered as a 400-mg BID oral dose on Days 8 to 14 (Period 2) after a high-fat meal.
98417|NCT01984229|E4|Reported Event|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
98418|NCT01984229|E3|Reported Event|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
98419|NCT01984229|E2|Reported Event|Cohort A: Posaconazole (Period 2)|Posaconazole was administered as a 400-mg BID oral dose on Days 8 to 14 (Period 2) after a high-fat meal.
98420|NCT01984229|E1|Reported Event|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
98421|NCT01983878|B1|Baseline|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
98422|NCT01983878|P1|Participant Flow|Ramucirumab 8 mg/kg|Ramucirumab 8 milligrams per kilogram (mg/kg) administered intravenously (IV) once every 2 weeks. Treatment continued until there is evidence of progressive disease (PD), the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
98423|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
98424|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
98425|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
98426|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
98427|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
98428|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
98429|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
98430|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
98431|NCT01983878|E1|Reported Event|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
98432|NCT01983839|B1|Baseline|Pharmacokinetics Moxifloxacin|Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered.
98433|NCT01983839|P1|Participant Flow|Pharmacokinetics Moxifloxacin|Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered.
98434|NCT01983839|O1|Outcome|Pharmacokinetics Moxifloxacin|"Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered.~The model estimated median values of total Cmax and fAUC0-24 for the current study population were3.99 mg/L (IQR 3.19; 5.29) and 32.78 mg.hr/L (IQR 22.75; 47.31). respectively."
98435|NCT01983839|O1|Outcome|Pharmacokinetics Moxifloxacin|"Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered.~The model estimated median values of total Cmax and fAUC0-24 for the current study population were3.99 mg/L (IQR 3.19; 5.29) and 32.78 mg.hr/L (IQR 22.75; 47.31). respectively."
98436|NCT01983839|E1|Reported Event|Pharmacokinetics Moxifloxacin|Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered.
98437|NCT01983787|B1|Baseline|Pharmacokinetics Piperacillin|Patients with cystic fibrosis and pulmonary exacerbation, treated with Piperacillin/Tazobactam, given as continuous infusion for a period of two weeks.
98438|NCT01983787|P1|Participant Flow|Pharmacokinetics Piperacillin|Patients with cystic fibrosis with pulmonary exacerbation, treated with Piperacillin/Tazobactam, given as continuous infusion for a period of two weeks.
98439|NCT01983787|O9|Outcome|Patient 10|MIC (mg/L) of pathogen detected in sputum: 2 mg/L
98440|NCT01983787|O8|Outcome|Patient 9|MIC (mg/L) of pathogen detected in sputum: 0.75 mg/L
98441|NCT01983787|O7|Outcome|Patient 8|MIC (mg/L) of pathogen detected in sputum: 3 mg/L
98442|NCT01983787|O6|Outcome|Patient 7|MIC (mg/L) of pathogen detected in sputum: 3 mg/L
98443|NCT01983787|O5|Outcome|Patient 6|MIC (mg/L) of pathogen detected in sputum: 0.5 mg/L
98444|NCT01983787|O4|Outcome|Patient 4|MIC (mg/L) of pathogen detected in sputum: 3 mg/L
98445|NCT01983787|O3|Outcome|Patient 3|MIC (mg/L) of pathogen detected in sputum: 16 mg/L
98446|NCT01983787|O2|Outcome|Patient 2|MIC (mg/L) of pathogen detected in sputum: 8 mg/L
98447|NCT01983787|O1|Outcome|Patient 1|MIC (mg/L) of pathogen detected in sputum: 3 mg/L
98448|NCT01983787|O9|Outcome|T>MIC 12g/Day, Patient 10|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
98449|NCT01983787|O8|Outcome|T>MIC 12g/Day, Patient 9|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Acromobacter. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
98450|NCT01983787|O7|Outcome|T>MIC 12g/Day, Patient 8|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
98451|NCT01983787|O6|Outcome|T>MIC 12g/Day, Patient 7|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
98452|NCT01983787|O5|Outcome|T>MIC12g/Day, Patient 6|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
98453|NCT01983787|O4|Outcome|T>MIC 16g/Day, Patient 4|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
98865|NCT01980940|O3|Outcome|ETOR 150 DMSO (Pt 1)|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
98454|NCT01983787|O3|Outcome|T>MIC 16g/Day, Patient 3|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Pseudomonas aeruginosa. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
98455|NCT01983787|O2|Outcome|T>MIC 16g/Day, Patient 2|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Pseudomonas aeruginosa. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
98456|NCT01983787|O1|Outcome|T>MIC 16g/Day, Patient 1|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
98457|NCT01983787|O2|Outcome|Pharmacokinetics Piperacillin 12g/Day|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.
98458|NCT01983787|O1|Outcome|Pharmacokinetics Piperacillin 16g/Day|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks.
98459|NCT01983787|E1|Reported Event|Pharmacokinetics Piperacillin|Patients with cystic fibrosis with pulmonary exacerbation, treated with Piperacillin/Tazobactam, given as continuous infusion for a period of two weeks.
98460|NCT01983683|B3|Baseline|Total|Total of all reporting groups
98461|NCT01983683|B2|Baseline|Vancomycin|Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
98462|NCT01983683|B1|Baseline|Cadazolid|Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
98463|NCT01983683|P2|Participant Flow|Vancomycin|Subjects with CDAD received oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days. Subjects were followed up for 30 day after the last dose of vancomycin. Subjects who had a first recurrence of CDAD during the follow-up period were offered to enter a re-treatment extension period with cadazolid (10 days of cadazolid + 30-day follow up)
98464|NCT01983683|P1|Participant Flow|Cadazolid|Subjects with Clostridium difficile-associated diarrhea (CDAD) received oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times a day (qid) for 10 days. Subjects were followed up for 30 days after the last dose of cadazolid. Subjects who had a first recurrence of CDAD during the follow-up period were offered to enter a re-treatment extension period with cadazolid (10 days of cadazolid + 30-day follow up)
98465|NCT01983683|O2|Outcome|Vancomycin|Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
98466|NCT01983683|O1|Outcome|Cadazolid|Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
98467|NCT01983683|O2|Outcome|Vancomycin|Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
98468|NCT01983683|O1|Outcome|Cadazolid|Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
98469|NCT01983683|O2|Outcome|Vancomycin|Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
98470|NCT01983683|O1|Outcome|Cadazolid|Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
98471|NCT01983683|O2|Outcome|Vancomycin|Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
98472|NCT01983683|O1|Outcome|Cadazolid|Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
98473|NCT01983683|O2|Outcome|Vancomycin|Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
98474|NCT01983683|O1|Outcome|Cadazolid|Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
98475|NCT01983683|O2|Outcome|Vancomycin|Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
98476|NCT01983683|O1|Outcome|Cadazolid|Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
98477|NCT01983683|O2|Outcome|Vancomycin|Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
98478|NCT01983683|O1|Outcome|Cadazolid|Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
98479|NCT01983683|O2|Outcome|Vancomycin|Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
98480|NCT01983683|O1|Outcome|Cadazolid|Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
98481|NCT01983683|O2|Outcome|Vancomycin|Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
98482|NCT01983683|O1|Outcome|Cadazolid|Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
98483|NCT01983683|O2|Outcome|Vancomycin|Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
98484|NCT01983683|O1|Outcome|Cadazolid|Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
98485|NCT01983683|E2|Reported Event|Vancomycin|oral vancomycin 125 mg 4 times per day (qid) for 10 days
98486|NCT01983683|E1|Reported Event|Cadazolid|oral cadazolid 250 mg twice daily (bid) for 10 days
98487|NCT01983566|B5|Baseline|Total|Total of all reporting groups
98488|NCT01983566|B4|Baseline|Dele + OMP / Dele Fasted / Dele Low Fat / Dele High Fat|"Dele after a 4 days pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily, followed by a washout phase, followed by Dele fasted, followed by a washout phase, followed by Dele after a standardised low-fat meal, followed by a washout phase, followed by Dele after a standardised high-fat, high-calorie meal.~Each Dele intake is a single dose of 3x 200mg Dele film-coated tablets after an overnight fast of at least 10 h.~The duration of a washout phase was at least 6 days."
100474|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
98489|NCT01983566|B3|Baseline|Dele Low Fat / Dele + OMP / Dele High Fat / Dele Fasted|"Dele after a standardised low-fat meal, followed by a washout phase, followed by Dele after a 4 days pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily, followed by a washout phase, followed by Dele after a standardised high-fat, high-calorie meal, followed by a washout phase, followed by Dele fasted.~Each Dele intake is a single dose of 3x 200mg Dele film-coated tablets after an overnight fast of at least 10 h.~The duration of a washout phase was at least 6 days."
98490|NCT01983566|B2|Baseline|Dele High Fat / Dele Low Fat / Dele Fasted / Dele + OMP|"Dele after a standardised high-fat, high-calorie meal, followed by a washout phase, followed by Dele after a standardised low-fat meal, followed by a washout phase, followed by Dele fasted, followed by a washout phase, followed by Dele after a 4 days pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily.~Each Dele intake is a single dose of 3x 200mg Dele film-coated tablets after an overnight fast of at least 10 h.~The duration of a washout phase was at least 6 days."
98491|NCT01983566|B1|Baseline|Dele Fasted / Dele High Fat / Dele + OMP / Dele Low Fat|"Dele fasted, followed by a washout phase, followed by Dele after a standardised high-fat, high- calorie meal, followed by a washout phase, followed by Dele after a 4 days pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily, followed by a washout phase, followed by Dele after a standardised low-fat meal.~Each Dele intake is a single dose of 3x 200mg Dele film-coated tablets after an overnight fast of at least 10 h.~The duration of a washout phase was at least 6 days."
98492|NCT01983566|P4|Participant Flow|Dele + OMP / Dele Fasted / Dele Low Fat / Dele High Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h.~All medications were administered oral with 240 mL of water."
98493|NCT01983566|P3|Participant Flow|Dele Low Fat / Dele + OMP / Dele High Fat / Dele Fasted|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h.~All medications were administered oral with 240 mL of water."
98494|NCT01983566|P2|Participant Flow|Dele High Fat / Dele Low Fat / Dele Fasted / Dele + OMP|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily.~All medications were administered oral with 240 mL of water."
98495|NCT01983566|P1|Participant Flow|Dele Fasted / Dele High Fat / Dele + OMP / Dele Low Fat|"Each subject received a single dose of 3 x 200 mg Deleobuvir (Dele) film-coated tablets after an overnight fast of at least 10 hours (h), followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h.~All medications were administered oral with 240 mL of water."
98496|NCT01983566|O4|Outcome|Dele + OMP|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily.~All medications were administered oral with 240 mL of water."
98497|NCT01983566|O3|Outcome|Dele Low Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
98498|NCT01983566|O2|Outcome|Dele High Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
98499|NCT01983566|O1|Outcome|Dele Fasted|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
98500|NCT01983566|O4|Outcome|Dele + OMP|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily.~All medications were administered oral with 240 mL of water."
98501|NCT01983566|O3|Outcome|Dele Low Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
98502|NCT01983566|O2|Outcome|Dele High Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
98689|NCT01981967|O2|Outcome|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
98503|NCT01983566|O1|Outcome|Dele Fasted|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
98504|NCT01983566|O4|Outcome|Dele + OMP|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily.~All medications were administered oral with 240 mL of water."
98505|NCT01983566|O3|Outcome|Dele Low Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
98506|NCT01983566|O2|Outcome|Dele High Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
98507|NCT01983566|O1|Outcome|Dele Fasted|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
98508|NCT01983566|E5|Reported Event|OMP Alone|One gastro-resistant hard capsule of Omeprazole (OMP) (40 mg) once daily in the evening for 4 days administered oral with 240 mL of water.
98509|NCT01983566|E4|Reported Event|Dele + OMP|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily.~All medications were administered oral with 240 mL of water."
98510|NCT01983566|E3|Reported Event|Dele Low Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
98511|NCT01983566|E2|Reported Event|Dele High Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
98512|NCT01983566|E1|Reported Event|Dele Fasted|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
98513|NCT01983254|B3|Baseline|Total|Total of all reporting groups
98514|NCT01983254|B2|Baseline|Education Program|"6 week access to a web-based, critical illness-specific education program~education program: web-based, ICU-specific education program"
98515|NCT01983254|B1|Baseline|Coping Skills Training|"6 sessions of weekly telephone-based coping skills training delivered by trained interventionist~coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation"
98516|NCT01983254|P2|Participant Flow|Education Program|"6 week access to a web-based, critical illness-specific education program~education program: web-based, ICU-specific education program"
98517|NCT01983254|P1|Participant Flow|Coping Skills Training|"6 sessions of weekly telephone-based coping skills training delivered by trained interventionist~coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation"
98518|NCT01983254|O2|Outcome|Education Program|"6 week access to a web-based, critical illness-specific education program~education program: web-based, ICU-specific education program"
98519|NCT01983254|O1|Outcome|Coping Skills Training|"6 sessions of weekly telephone-based coping skills training delivered by trained interventionist~coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation"
98520|NCT01983254|O2|Outcome|Education Program|"6 week access to a web-based, critical illness-specific education program~education program: web-based, ICU-specific education program"
98521|NCT01983254|O1|Outcome|Coping Skills Training|"6 sessions of weekly telephone-based coping skills training delivered by trained interventionist~coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation"
98522|NCT01983254|O2|Outcome|Education Program|"6 week access to a web-based, critical illness-specific education program~education program: web-based, ICU-specific education program"
98523|NCT01983254|O1|Outcome|Coping Skills Training|"6 sessions of weekly telephone-based coping skills training delivered by trained interventionist~coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation"
98524|NCT01983254|E2|Reported Event|Education Program|"6 week access to a web-based, critical illness-specific education program~education program: web-based, ICU-specific education program"
98525|NCT01983254|E1|Reported Event|Coping Skills Training|"6 sessions of weekly telephone-based coping skills training delivered by trained interventionist~coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation"
98526|NCT01983111|B3|Baseline|Total|Total of all reporting groups
98527|NCT01983111|B2|Baseline|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
98528|NCT01983111|B1|Baseline|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
98529|NCT01983111|P2|Participant Flow|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
98530|NCT01983111|P1|Participant Flow|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
98531|NCT01983111|O2|Outcome|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
98533|NCT01983111|O2|Outcome|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
98534|NCT01983111|O1|Outcome|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
98535|NCT01983111|O2|Outcome|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
98536|NCT01983111|O1|Outcome|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
98537|NCT01983111|O2|Outcome|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
98538|NCT01983111|O1|Outcome|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
98539|NCT01983111|O2|Outcome|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
98540|NCT01983111|O1|Outcome|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
98541|NCT01983111|O2|Outcome|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
98542|NCT01983111|O1|Outcome|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
98543|NCT01983111|E2|Reported Event|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets.~Safety was analyzed based on data for AEs, clinical laboratory tests, vital signs, and physical examination in the Safety set which consisted of 65 subjects who administered the comparator(tramadol/acetaminophen) and had at least one time of safety assessment."
98544|NCT01983111|E1|Reported Event|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days.~Safety was analyzed based on data for AEs, clinical laboratory tests, vital signs, and physical examination in the Safety set which consisted of 69 subjects who administered the study drug(buprenorphine) and had at least one time of safety assessment."
98545|NCT01983020|B5|Baseline|Total|Total of all reporting groups
98546|NCT01983020|B4|Baseline|Placebo|Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
98547|NCT01983020|B3|Baseline|Ketamine and Lidocaine|"Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour~Lidocaine~Ketamine"
98548|NCT01983020|B2|Baseline|Lidocaine|"Lidocaine infused at 0.5 mg/kg/hour.~Lidocaine"
98549|NCT01983020|B1|Baseline|Ketamine|"Ketamine infused at 0.25 mg/kg/hour.~Ketamine"
98550|NCT01983020|P4|Participant Flow|Placebo|Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
98551|NCT01983020|P3|Participant Flow|Ketamine and Lidocaine|"Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour~Lidocaine~Ketamine"
98552|NCT01983020|P2|Participant Flow|Lidocaine|"Lidocaine infused at 0.5 mg/kg/hour.~Lidocaine"
98553|NCT01983020|P1|Participant Flow|Ketamine|"Ketamine infused at 0.25 mg/kg/hour.~Ketamine"
98554|NCT01983020|O4|Outcome|Placebo|Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
98555|NCT01983020|O3|Outcome|Ketamine and Lidocaine|"Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour~Lidocaine~Ketamine"
98556|NCT01983020|O2|Outcome|Lidocaine|"Lidocaine infused at 0.5 mg/kg/hour.~Lidocaine"
98557|NCT01983020|O1|Outcome|Ketamine|"Ketamine infused at 0.25 mg/kg/hour.~Ketamine"
98558|NCT01983020|E4|Reported Event|Placebo|Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
98559|NCT01983020|E3|Reported Event|Ketamine and Lidocaine|"Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour~Lidocaine~Ketamine"
98560|NCT01983020|E2|Reported Event|Lidocaine|"Lidocaine infused at 0.5 mg/kg/hour.~Lidocaine"
98561|NCT01983020|E1|Reported Event|Ketamine|"Ketamine infused at 0.25 mg/kg/hour.~Ketamine"
98562|NCT01982812|B3|Baseline|Total|Total of all reporting groups
98563|NCT01982812|B2|Baseline|Standard AED|"Standard AED regimen~Standard AED: Active comparitor, Standard AED"
98564|NCT01982812|B1|Baseline|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.~Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
98565|NCT01982812|P2|Participant Flow|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion~2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
98690|NCT01981967|O1|Outcome|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
98566|NCT01982812|P1|Participant Flow|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.~Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
98567|NCT01982812|O2|Outcome|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion~2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
98568|NCT01982812|O1|Outcome|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.~Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
98569|NCT01982812|O2|Outcome|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion~2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
98570|NCT01982812|O1|Outcome|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.~Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
98571|NCT01982812|O2|Outcome|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion~2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
98572|NCT01982812|O1|Outcome|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.~Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
98573|NCT01982812|O2|Outcome|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion~2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
98574|NCT01982812|O1|Outcome|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.~Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
98575|NCT01982812|E2|Reported Event|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion~2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
98576|NCT01982812|E1|Reported Event|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.~Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
98577|NCT01982773|B3|Baseline|Total|Total of all reporting groups
98578|NCT01982773|B2|Baseline|EnhancedTreatment As Usual|"Subjects will be issued printed materials guiding them in coping with suicidal thoughts, which include information about coping strategies and emergency contact information.~Enhanced Treatment as Usual: Printed materials"
98579|NCT01982773|B1|Baseline|Virtual Hope Box Smartphone App|"Use of the smartphone app, Virtual Hope Box on their personal smartphone~Virtual Hope Box Smartphone App: Smartphone app"
98580|NCT01982773|P2|Participant Flow|EnhancedTreatment As Usual|"Subjects will be issued printed materials guiding them in coping with suicidal thoughts, which include information about coping strategies and emergency contact information.~Enhanced Treatment as Usual: Printed materials"
98581|NCT01982773|P1|Participant Flow|Virtual Hope Box Smartphone App|"Use of the smartphone app, Virtual Hope Box on their personal smartphone~Virtual Hope Box Smartphone App: Smartphone app"
98582|NCT01982773|O2|Outcome|EnhancedTreatment As Usual|"Subjects will be issued printed materials guiding them in coping with suicidal thoughts, which include information about coping strategies and emergency contact information.~Enhanced Treatment as Usual: Printed materials"
98583|NCT01982773|O1|Outcome|Virtual Hope Box Smartphone App|"Use of the smartphone app, Virtual Hope Box on their personal smartphone~Virtual Hope Box Smartphone App: Smartphone app"
98584|NCT01982773|O2|Outcome|EnhancedTreatment As Usual|"Subjects will be issued printed materials guiding them in coping with suicidal thoughts, which include information about coping strategies and emergency contact information.~Enhanced Treatment as Usual: Printed materials"
98585|NCT01982773|O1|Outcome|Virtual Hope Box Smartphone App|"Use of the smartphone app, Virtual Hope Box on their personal smartphone~Virtual Hope Box Smartphone App: Smartphone app"
98586|NCT01982773|O2|Outcome|EnhancedTreatment As Usual|"Subjects will be issued printed materials guiding them in coping with suicidal thoughts, which include information about coping strategies and emergency contact information.~Enhanced Treatment as Usual: Printed materials"
98587|NCT01982773|O1|Outcome|Virtual Hope Box Smartphone App|"Use of the smartphone app, Virtual Hope Box on their personal smartphone~Virtual Hope Box Smartphone App: Smartphone app"
98588|NCT01982773|O2|Outcome|EnhancedTreatment As Usual|"Subjects will be issued printed materials guiding them in coping with suicidal thoughts, which include information about coping strategies and emergency contact information.~Enhanced Treatment as Usual: Printed materials"
98589|NCT01982773|O1|Outcome|Virtual Hope Box Smartphone App|"Use of the smartphone app, Virtual Hope Box on their personal smartphone~Virtual Hope Box Smartphone App: Smartphone app"
98590|NCT01982773|E2|Reported Event|EnhancedTreatment As Usual|"Subjects will be issued printed materials guiding them in coping with suicidal thoughts, which include information about coping strategies and emergency contact information.~Enhanced Treatment as Usual: Printed materials"
98591|NCT01982773|E1|Reported Event|Virtual Hope Box Smartphone App|"Use of the smartphone app, Virtual Hope Box on their personal smartphone~Virtual Hope Box Smartphone App: Smartphone app"
98592|NCT01982695|B3|Baseline|Total|Total of all reporting groups
98593|NCT01982695|B2|Baseline|Lospartan|Lisinopril
98594|NCT01982695|B1|Baseline|Lisinopril|Lisinopril
98595|NCT01982695|P2|Participant Flow|Losartan|Approximately 0.7 mg/kg/day in oral capsules
98596|NCT01982695|P1|Participant Flow|Lisinopril|Approximately 0.07 mg/kg/day in oral capsules
98597|NCT01982695|O2|Outcome|Losartan|Losartan
98598|NCT01982695|O1|Outcome|Lisinopril|Lisinopril
98599|NCT01982695|E2|Reported Event|Losartan|Losartan
98600|NCT01982695|E1|Reported Event|Lisinopril|Lisinopril
98601|NCT01982539|B1|Baseline|Zipsor® (Liquid Filled Capsules)|Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
98602|NCT01982539|P1|Participant Flow|Zipsor® (Liquid Filled Capsules)|Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
98603|NCT01982539|O1|Outcome|Zipsor® (Liquid Filled Capsules)|Administration of Zipsor® (liquid filled capsules) to subjects with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
98604|NCT01982539|E1|Reported Event|Zipsor® (Liquid Filled Capsules)|Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
98605|NCT01982435|B3|Baseline|Total|Total of all reporting groups
98606|NCT01982435|B2|Baseline|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.~Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
98607|NCT01982435|B1|Baseline|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.~Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
98608|NCT01982435|P2|Participant Flow|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.~Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
98609|NCT01982435|P1|Participant Flow|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.~Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
98610|NCT01982435|O2|Outcome|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.~Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
98611|NCT01982435|O1|Outcome|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.~Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
98612|NCT01982435|O2|Outcome|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.~Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
98613|NCT01982435|O1|Outcome|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.~Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
98614|NCT01982435|O2|Outcome|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.~Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
98615|NCT01982435|O1|Outcome|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.~Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
98643|NCT01982383|E2|Reported Event|No Treatment|"Patients randomized to this treatment arm, will not receive treatment for CSC. They will continue to be observed at month 1 and month 3. If any worsening of pathology is found during the follow up visits, the patient will be removed from the study and given appropriate standard of care by the attending~No treatment"
98866|NCT01980940|O2|Outcome|ETOR 75 PG (Pt 1)|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
98616|NCT01982435|O2|Outcome|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.~Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
98617|NCT01982435|O1|Outcome|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.~Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
98618|NCT01982435|O2|Outcome|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.~Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
98619|NCT01982435|O1|Outcome|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.~Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
98620|NCT01982435|O2|Outcome|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.~Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
98621|NCT01982435|O1|Outcome|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.~Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
98622|NCT01982435|O2|Outcome|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.~Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
98623|NCT01982435|O1|Outcome|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.~Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
98624|NCT01982435|O2|Outcome|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.~Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
98625|NCT01982435|O1|Outcome|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.~Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
98626|NCT01982435|O2|Outcome|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.~Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
98627|NCT01982435|O1|Outcome|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.~Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
100475|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
98628|NCT01982435|O2|Outcome|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.~Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
98629|NCT01982435|O1|Outcome|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.~Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
98630|NCT01982435|O2|Outcome|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.~Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
98631|NCT01982435|O1|Outcome|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.~Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
98632|NCT01982435|O2|Outcome|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.~Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
98633|NCT01982435|O1|Outcome|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.~Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
98634|NCT01982435|E2|Reported Event|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.~Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
98635|NCT01982435|E1|Reported Event|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.~Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
98636|NCT01982383|B3|Baseline|Total|Total of all reporting groups
98637|NCT01982383|B2|Baseline|No Treatment|"Patients randomized to this treatment arm, will not receive treatment for CSC. They will continue to be observed at month 1 and month 3. If any worsening of pathology is found during the follow up visits, the patient will be removed from the study and given appropriate standard of care by the attending~No treatment"
98638|NCT01982383|B1|Baseline|Micropulse Laser Treatment|"Patient's randomized to ML treatment would be treated with the following settings: 200 micron spot size, 0.2 second duration, 15% duty cycle, and 300 milliWatt power. Their eyes would be dilated prior to treatment with standard mydriatic medications, including Tropicamide and Phenylephrine~Micropulse Laser Treatment"
98639|NCT01982383|P2|Participant Flow|No Treatment|"Patients randomized to this treatment arm, will not receive treatment for CSC. They will continue to be observed at month 1 and month 3. If any worsening of pathology is found during the follow up visits, the patient will be removed from the study and given appropriate standard of care by the attending~No treatment"
98640|NCT01982383|P1|Participant Flow|Micropulse Laser Treatment|"Patient's randomized to ML treatment would be treated with the following settings: 200 micron spot size, 0.2 second duration, 15% duty cycle, and 300 milliWatt power. Their eyes would be dilated prior to treatment with standard mydriatic medications, including Tropicamide and Phenylephrine~Micropulse Laser Treatment"
98641|NCT01982383|O2|Outcome|No Treatment|"Patients randomized to this treatment arm, will not receive treatment for CSC. They will continue to be observed at month 1 and month 3. If any worsening of pathology is found during the follow up visits, the patient will be removed from the study and given appropriate standard of care by the attending~No treatment"
98642|NCT01982383|O1|Outcome|Micropulse Laser Treatment|"Patient's randomized to ML treatment would be treated with the following settings: 200 micron spot size, 0.2 second duration, 15% duty cycle, and 300 milliWatt power. Their eyes would be dilated prior to treatment with standard mydriatic medications, including Tropicamide and Phenylephrine~Micropulse Laser Treatment"
98688|NCT01981967|O1|Outcome|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
98644|NCT01982383|E1|Reported Event|Micropulse Laser Treatment|"Patient's randomized to ML treatment would be treated with the following settings: 200 micron spot size, 0.2 second duration, 15% duty cycle, and 300 milliWatt power. Their eyes would be dilated prior to treatment with standard mydriatic medications, including Tropicamide and Phenylephrine~Micropulse Laser Treatment"
98645|NCT01982292|B3|Baseline|Total|Total of all reporting groups
98646|NCT01982292|B2|Baseline|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
98647|NCT01982292|B1|Baseline|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
98648|NCT01982292|P2|Participant Flow|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
98649|NCT01982292|P1|Participant Flow|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
98650|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
98651|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
98652|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
98653|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
98654|NCT01982292|O2|Outcome|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
98655|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
98656|NCT01982292|O2|Outcome|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
98657|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
98658|NCT01982292|O2|Outcome|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
98659|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
98660|NCT01982292|O2|Outcome|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
98661|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
98662|NCT01982292|O2|Outcome|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
98663|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
98664|NCT01982292|E2|Reported Event|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
98665|NCT01982292|E1|Reported Event|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
98666|NCT01982253|B4|Baseline|Total|Total of all reporting groups
98667|NCT01982253|B3|Baseline|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
98668|NCT01982253|B2|Baseline|Fasiglifam 25 mg BID|Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.
98669|NCT01982253|B1|Baseline|Placebo|Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.
98670|NCT01982253|P3|Participant Flow|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
98671|NCT01982253|P2|Participant Flow|Fasiglifam 25 mg BID|Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.
98672|NCT01982253|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.
98673|NCT01982253|O3|Outcome|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
98674|NCT01982253|O2|Outcome|Fasiglifam 25 mg BID|Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.
98675|NCT01982253|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.
98676|NCT01982253|O3|Outcome|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
98677|NCT01982253|O2|Outcome|Fasiglifam 25 mg BID|Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.
98678|NCT01982253|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.
98679|NCT01982253|E3|Reported Event|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
98680|NCT01982253|E2|Reported Event|Fasiglifam 25 mg BID|Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.
98681|NCT01982253|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.
98682|NCT01981967|B3|Baseline|Total|Total of all reporting groups
98683|NCT01981967|B2|Baseline|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
98684|NCT01981967|B1|Baseline|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
98685|NCT01981967|P2|Participant Flow|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
98686|NCT01981967|P1|Participant Flow|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
98687|NCT01981967|O2|Outcome|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
98691|NCT01981967|O2|Outcome|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
98692|NCT01981967|O1|Outcome|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
98693|NCT01981967|E2|Reported Event|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
98694|NCT01981967|E1|Reported Event|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
98695|NCT01981863|B3|Baseline|Total|Total of all reporting groups
98696|NCT01981863|B2|Baseline|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm~Placebo: Placebo administered in same volume as in experimental arm."
98697|NCT01981863|B1|Baseline|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo~Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo."
98698|NCT01981863|P2|Participant Flow|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm~Placebo: Placebo administered in same volume as in experimental arm."
98699|NCT01981863|P1|Participant Flow|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo~Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo."
98700|NCT01981863|O2|Outcome|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm~Placebo: Placebo administered in same volume as in experimental arm."
98701|NCT01981863|O1|Outcome|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo~Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo."
98702|NCT01981863|O2|Outcome|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm~Placebo: Placebo administered in same volume as in experimental arm."
98703|NCT01981863|O1|Outcome|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo~Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo."
98704|NCT01981863|O2|Outcome|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm~Placebo: Placebo administered in same volume as in experimental arm."
98705|NCT01981863|O1|Outcome|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo~Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo."
98706|NCT01981863|E2|Reported Event|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm~Placebo: Placebo administered in same volume as in experimental arm.~No adverse events to report."
98707|NCT01981863|E1|Reported Event|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo~Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo.~No adverse advents to report."
98708|NCT01981616|B3|Baseline|Total|Total of all reporting groups
98709|NCT01981616|B2|Baseline|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
98710|NCT01981616|B1|Baseline|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
98711|NCT01981616|P2|Participant Flow|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
98712|NCT01981616|P1|Participant Flow|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
98713|NCT01981616|O2|Outcome|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
98714|NCT01981616|O1|Outcome|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
98715|NCT01981616|O2|Outcome|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
98716|NCT01981616|O1|Outcome|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
98717|NCT01981616|O2|Outcome|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
98718|NCT01981616|O1|Outcome|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
98719|NCT01981616|O2|Outcome|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
98720|NCT01981616|O1|Outcome|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
98721|NCT01981616|E2|Reported Event|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
98722|NCT01981616|E1|Reported Event|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
98723|NCT01981564|B3|Baseline|Total|Total of all reporting groups
98724|NCT01981564|B2|Baseline|Standard ASthma Education Control Group|"STandard asthma education delivered in home by nurse~Asthma Express Intervention: Asthma Express clinic visit for asthma education + nurse home visit~Asthma Express Control Arm: Asthma Express home nurse visits for asthma education"
98725|NCT01981564|B1|Baseline|Asthma Express Intervention|"Clinic visit for asthma education + nurse home visits~Asthma Express Intervention: Asthma Express clinic visit for asthma education + nurse home visit~Asthma Express Control Arm: Asthma Express home nurse visits for asthma education"
98726|NCT01981564|P2|Participant Flow|Standard ASthma Education Control Group|"STandard asthma education delivered in home by nurse~Asthma Express Intervention: Asthma Express clinic visit for asthma education + nurse home visit~Asthma Express Control Arm: Asthma Express home nurse visits for asthma education"
98727|NCT01981564|P1|Participant Flow|Asthma Express Intervention|"Clinic visit for asthma education + nurse home visits~Asthma Express Intervention: Asthma Express clinic visit for asthma education + nurse home visit~Asthma Express Control Arm: Asthma Express home nurse visits for asthma education"
98728|NCT01981564|O2|Outcome|Standard Asthma Education Control Group|Asthma Express home nurse visits for asthma education
98729|NCT01981564|O1|Outcome|Asthma Express Intervention|Asthma Express clinic visit for asthma education + nurse home visit
98730|NCT01981564|O2|Outcome|Standard ASthma Education Control Group|Asthma Express home nurse visits for asthma education
98731|NCT01981564|O1|Outcome|Asthma Express Intervention|Asthma Express clinic visit for asthma education + nurse home visit
98732|NCT01981564|E2|Reported Event|Standard ASthma Education Control Group|"STandard asthma education delivered in home by nurse~Asthma Express Intervention: Asthma Express clinic visit for asthma education + nurse home visit~Asthma Express Control Arm: Asthma Express home nurse visits for asthma education"
98733|NCT01981564|E1|Reported Event|Asthma Express Intervention|"Clinic visit for asthma education + nurse home visits~Asthma Express Intervention: Asthma Express clinic visit for asthma education + nurse home visit~Asthma Express Control Arm: Asthma Express home nurse visits for asthma education"
98734|NCT01981473|B4|Baseline|Total|Total of all reporting groups
98735|NCT01981473|B3|Baseline|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98736|NCT01981473|B2|Baseline|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98737|NCT01981473|B1|Baseline|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98738|NCT01981473|P3|Participant Flow|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98739|NCT01981473|P2|Participant Flow|Adalimumab|Participants who had received treatment with Adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98740|NCT01981473|P1|Participant Flow|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98741|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98742|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98743|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98744|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98745|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98746|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98747|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98748|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98749|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98750|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98751|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98752|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98753|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98754|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98755|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98756|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98757|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98758|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
100476|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
98759|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98760|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98761|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98762|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98763|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98764|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98765|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98766|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98767|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98768|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98769|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98770|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98771|NCT01981473|O2|Outcome|% AA-|Proportion of participants negative for antidrug antibodies among those treated with etanercept versus those treated with monoclonal antibodies (adalimumab or infliximab)
98772|NCT01981473|O1|Outcome|% AA+|Proportion of participants positive for antidrug antibodies among those treated with etanercept versus those treated with monoclonal antibodies (adalimumab or infliximab)
98773|NCT01981473|O2|Outcome|Adalimumab/ Infliximab|Participants who had received treatment with adalimumab or infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98774|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98775|NCT01981473|E3|Reported Event|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98776|NCT01981473|E2|Reported Event|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98777|NCT01981473|E1|Reported Event|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
98778|NCT01981356|B3|Baseline|Total|Total of all reporting groups
98779|NCT01981356|B2|Baseline|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
98780|NCT01981356|B1|Baseline|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
98781|NCT01981356|P2|Participant Flow|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
98782|NCT01981356|P1|Participant Flow|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
98783|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
98784|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
98785|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
98786|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
98787|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
98788|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
98789|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
98790|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
98791|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
98792|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
98793|NCT01981356|O1|Outcome|Inpatient Psychiatry Unit Staff Members|Barriers and facilitators were assessed through interviews of four inpatient psychiatry unit staff (on nursing assistant, one nurse, two psychologists).
98794|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
98795|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
98796|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
98797|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
98862|NCT01980940|O6|Outcome|Placebo (Pt 1) (Deviation)|Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
100847|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
98798|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
98799|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
98800|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
98801|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
98802|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
98803|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
98804|NCT01981356|E2|Reported Event|Treatment as Usual (TAU)|"TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.~Treatment as Usual (TAU): All patients admitted to the acute psychiatry unit are administered anti-psychotic and/or other psychotropic medication during their inpatient stay. Patients participate in standard milieu therapy on the unit (group and activities therapies, and individual therapy as needed). Therapy on the unit focuses on psycho-education about illness, symptom identification, mood management techniques, stress reduction, and relapse prevention. Patients also receive unstructured individual therapy and case management as appropriate."
98805|NCT01981356|E1|Reported Event|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
98806|NCT01981057|B3|Baseline|Total|Total of all reporting groups
98807|NCT01981057|B2|Baseline|Individual|"individually prescribed parenteral receipt~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
98808|NCT01981057|B1|Baseline|Numeta|"parenteral receipt prescribed with Numeta~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
98809|NCT01981057|P2|Participant Flow|Individual|"individually prescribed parenteral receipt~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
98810|NCT01981057|P1|Participant Flow|Numeta|"parenteral receipt prescribed with Numeta~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
98811|NCT01981057|O2|Outcome|Individual|"individually prescribed parenteral receipt~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
98812|NCT01981057|O1|Outcome|Numeta|"parenteral receipt prescribed with Numeta~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
98813|NCT01981057|E2|Reported Event|Individual|"individually prescribed parenteral receipt~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
98814|NCT01981057|E1|Reported Event|Numeta|"parenteral receipt prescribed with Numeta~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
98815|NCT01980992|B3|Baseline|Total|Total of all reporting groups
98816|NCT01980992|B2|Baseline|Wheat OIT|2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
98867|NCT01980940|O1|Outcome|ETOR 75 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
98817|NCT01980992|B1|Baseline|Placebo Then High Dose Group|52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
98818|NCT01980992|P2|Participant Flow|Wheat OIT|2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
98819|NCT01980992|P1|Participant Flow|Placebo Then High Dose Group|52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
98820|NCT01980992|O4|Outcome|Placebo Crossover|52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
98821|NCT01980992|O3|Outcome|Wheat OIT After 1 Year|2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
98822|NCT01980992|O2|Outcome|Placebo Before 1 Year|During the first year of 52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
98823|NCT01980992|O1|Outcome|Wheat OIT Before 1 Year|During the first year of 2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
98824|NCT01980992|O1|Outcome|Placebo Then High Dose Group|52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
98825|NCT01980992|O2|Outcome|Wheat OIT|2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
98826|NCT01980992|O1|Outcome|Placebo Then High Dose Group|52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
98827|NCT01980992|O2|Outcome|Wheat OIT|2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
98828|NCT01980992|O1|Outcome|Placebo Then High Dose Group|52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
98829|NCT01980992|O2|Outcome|Wheat OIT|2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
98830|NCT01980992|O1|Outcome|Placebo|52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a week 52 7443mg wheat protein oral food challenge (OFC).
98831|NCT01980992|E4|Reported Event|Placebo Crossover|52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
98832|NCT01980992|E3|Reported Event|Wheat OIT After 1 Year|2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
98833|NCT01980992|E2|Reported Event|Placebo Before 1 Year|52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
98863|NCT01980940|O5|Outcome|ETOR OD (Pt 1)|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
98834|NCT01980992|E1|Reported Event|Wheat OIT Before 1 Year|2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
98835|NCT01980940|B9|Baseline|Total|Total of all reporting groups
98836|NCT01980940|B8|Baseline|Pt 2: Placebo|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
98837|NCT01980940|B7|Baseline|Pt 2: ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
98838|NCT01980940|B6|Baseline|Pt 1: Placebo (Deviation)|Participants randomized to a treatment sequence in Part 1 who received single dose placebo gel (1.97 or 3.94 mL) applied topically in error instead of active study drug and dropped out after the first treatment period in the sequence. Included in the safety assessments only.
98839|NCT01980940|B5|Baseline|Pt 1: ETOR OD/ ETOR 150 DMSO/ ETOR 75 DMSO/ ETOR 75 PG|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel (DMSO formulation administered in error/overdose), followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
98840|NCT01980940|B4|Baseline|Pt 1: ETOR 150 PG/ETOR 150 DMSO/ETOR 75 PG/ETOR 75 DMSO|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
98841|NCT01980940|B3|Baseline|Pt 1: ETOR 150 DMSO/ETOR 75 PG/ETOR 150 PG/ETOR 75 DMSO|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel. All treatments were applied topically.
98842|NCT01980940|B2|Baseline|Pt 1: ETOR 75 PG/ETOR 75 DMSO/ETOR 150 DMSO/ETOR 150 PG|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel. All treatments were applied topically.
98843|NCT01980940|B1|Baseline|Pt 1: ETOR 75 DMSO/ETOR 150 PG/ETOR 75 PG/ETOR 150 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel. All treatments were applied topically.
98844|NCT01980940|P8|Participant Flow|Pt 2: Placebo|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
98845|NCT01980940|P7|Participant Flow|Pt 2: ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
98846|NCT01980940|P6|Participant Flow|Pt 1: Placebo (Deviation)|Participants randomized to a treatment sequence in Part 1 who received single dose placebo gel (1.97 or 3.94 mL) applied topically in error instead of active study drug and dropped out after the first treatment period in the sequence. Included in the safety assessments only.
98847|NCT01980940|P5|Participant Flow|Pt 1: ETOR OD/ ETOR 150 DMSO/ ETOR 75 DMSO/ ETOR 75 PG|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel (DMSO formulation administered in error/overdose), followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
98848|NCT01980940|P4|Participant Flow|Pt 1: ETOR 150 PG/ETOR 150 DMSO/ETOR 75 PG/ETOR 75 DMSO|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
98849|NCT01980940|P3|Participant Flow|Pt 1: ETOR 150 DMSO/ETOR 75 PG/ETOR 150 PG/ETOR 75 DMSO|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel. All treatments were applied topically.
98850|NCT01980940|P2|Participant Flow|Pt 1: ETOR 75 PG/ETOR 75 DMSO/ETOR 150 DMSO/ETOR 150 PG|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel. All treatments were applied topically.
98851|NCT01980940|P1|Participant Flow|Pt 1: ETOR 75 DMSO/ETOR 150 PG/ETOR 75 PG/ETOR 150 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel. All treatments were applied topically.
98852|NCT01980940|O8|Outcome|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
98853|NCT01980940|O7|Outcome|ETOR 50 DMSO (Pt 2)|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
98854|NCT01980940|O6|Outcome|Placebo (Pt 1) (Deviation)|Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
98855|NCT01980940|O5|Outcome|ETOR OD (Pt 1)|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
98856|NCT01980940|O4|Outcome|ETOR 150 PG (Pt 1)|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
98857|NCT01980940|O3|Outcome|ETOR 150 DMSO (Pt 1)|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
98858|NCT01980940|O2|Outcome|ETOR 75 PG (Pt 1)|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
98859|NCT01980940|O1|Outcome|ETOR 75 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
98860|NCT01980940|O8|Outcome|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
98861|NCT01980940|O7|Outcome|ETOR 50 DMSO (Pt 2)|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
98868|NCT01980940|O2|Outcome|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
98869|NCT01980940|O1|Outcome|ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
98870|NCT01980940|O2|Outcome|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
98871|NCT01980940|O1|Outcome|ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
98872|NCT01980940|O2|Outcome|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
98873|NCT01980940|O1|Outcome|ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
98874|NCT01980940|O2|Outcome|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
98875|NCT01980940|O1|Outcome|ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
98876|NCT01980940|O6|Outcome|Placebo (Pt 1) (Deviation)|Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
98877|NCT01980940|O5|Outcome|ETOR OD|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
98878|NCT01980940|O4|Outcome|ETOR 150 PG|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
98879|NCT01980940|O3|Outcome|ETOR 150 DMSO|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
98880|NCT01980940|O2|Outcome|ETOR 75 PG|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
98881|NCT01980940|O1|Outcome|ETOR 75 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
98882|NCT01980940|O6|Outcome|Placebo (Pt 1) (Deviation)|Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
98883|NCT01980940|O5|Outcome|ETOR OD|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
98884|NCT01980940|O4|Outcome|ETOR 150 PG|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
98885|NCT01980940|O3|Outcome|ETOR 150 DMSO|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
98886|NCT01980940|O2|Outcome|ETOR 75 PG|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
98887|NCT01980940|O1|Outcome|ETOR 75 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
98888|NCT01980940|O6|Outcome|Placebo (Pt 1) (Deviation)|Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
98889|NCT01980940|O5|Outcome|ETOR OD|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
98890|NCT01980940|O4|Outcome|ETOR 150 PG|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
98891|NCT01980940|O3|Outcome|ETOR 150 DMSO|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
98892|NCT01980940|O2|Outcome|ETOR 75 PG|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
98893|NCT01980940|O1|Outcome|ETOR 75 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
98894|NCT01980940|E8|Reported Event|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
98895|NCT01980940|E7|Reported Event|ETOR 50 DMSO (Pt 2)|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
98896|NCT01980940|E6|Reported Event|Placebo (Pt 1) (Deviation)|Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
98897|NCT01980940|E5|Reported Event|ETOR OD (Pt 1)|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
98898|NCT01980940|E4|Reported Event|ETOR 150 PG (Pt 1)|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
98899|NCT01980940|E3|Reported Event|ETOR 150 DMSO (Pt 1)|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
98900|NCT01980940|E2|Reported Event|ETOR 75 PG (Pt 1)|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
98901|NCT01980940|E1|Reported Event|ETOR 75 DMSO (Pt 1)|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
98902|NCT01980888|B3|Baseline|Total|Total of all reporting groups
98903|NCT01980888|B2|Baseline|Placebo+Bendamustine+Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
98904|NCT01980888|B1|Baseline|Idelalisib+Bendamustine+Rituximab|Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
98905|NCT01980888|P2|Participant Flow|Placebo+Bendamustine+Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
98906|NCT01980888|P1|Participant Flow|Idelalisib+Bendamustine+Rituximab|Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
98907|NCT01980888|O2|Outcome|Placebo+Bendamustine+Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
98908|NCT01980888|O1|Outcome|Idelalisib+Bendamustine+Rituximab|Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
99168|NCT01978314|O4|Outcome|Cohort 4|a diagnosis of either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI
98909|NCT01980888|O2|Outcome|Placebo+Bendamustine+Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
98910|NCT01980888|O1|Outcome|Idelalisib+Bendamustine+Rituximab|Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
98911|NCT01980888|O2|Outcome|Placebo+Bendamustine+Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
98912|NCT01980888|O1|Outcome|Idelalisib+Bendamustine+Rituximab|Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
98913|NCT01980888|O2|Outcome|Placebo+Bendamustine+Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
98914|NCT01980888|O1|Outcome|Idelalisib+Bendamustine+Rituximab|Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
98915|NCT01980888|O2|Outcome|Placebo+Bendamustine+Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
98916|NCT01980888|O1|Outcome|Idelalisib+Bendamustine+Rituximab|Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
98917|NCT01980888|O2|Outcome|Placebo+Bendamustine+Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
98918|NCT01980888|O1|Outcome|Idelalisib+Bendamustine+Rituximab|Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
98919|NCT01980888|E2|Reported Event|Placebo+Bendamustine+Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
98920|NCT01980888|E1|Reported Event|Idelalisib+Bendamustine+Rituximab|Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 6 total cycles) + rituximab (375 mg/m^2 on Day 1 and 500 mg/m^2 thereafter for at total of 6 infusions)
98921|NCT01980875|B4|Baseline|Total|Total of all reporting groups
98922|NCT01980875|B3|Baseline|Randomized: Obinutuzumab+Chlorambucil|Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
98923|NCT01980875|B2|Baseline|Randomized: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
98924|NCT01980875|B1|Baseline|Safety Run-In: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
98925|NCT01980875|P3|Participant Flow|Randomized: Obinutuzumab+Chlorambucil|Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
98926|NCT01980875|P2|Participant Flow|Randomized: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
98927|NCT01980875|P1|Participant Flow|Safety Run-In: Idelalisib+Obinutuzumab|Idelalisib (Zydelig®) 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
98928|NCT01980875|O3|Outcome|Randomized: Obinutuzumab+Chlorambucil|Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
98929|NCT01980875|O2|Outcome|Randomized: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
98930|NCT01980875|O1|Outcome|Safety Run-In: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
98931|NCT01980875|O3|Outcome|Randomized: Obinutuzumab+Chlorambucil|Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
98932|NCT01980875|O2|Outcome|Randomized: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
98933|NCT01980875|O1|Outcome|Safety Run-In: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
98934|NCT01980875|O3|Outcome|Randomized: Obinutuzumab+Chlorambucil|Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
98935|NCT01980875|O2|Outcome|Randomized: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
98936|NCT01980875|O1|Outcome|Safety Run-In: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
98937|NCT01980875|O3|Outcome|Randomized: Obinutuzumab+Chlorambucil|Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
98938|NCT01980875|O2|Outcome|Randomized: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
98939|NCT01980875|O1|Outcome|Safety Run-In: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
99169|NCT01978314|O3|Outcome|Cohort 3|eGFR renal function 15-29 mL/min for stage 4, severe CKD
98940|NCT01980875|O3|Outcome|Randomized: Obinutuzumab+Chlorambucil|Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
98941|NCT01980875|O2|Outcome|Randomized: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
98942|NCT01980875|O1|Outcome|Safety Run-In: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
98943|NCT01980875|O3|Outcome|Randomized: Obinutuzumab+Chlorambucil|Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
98944|NCT01980875|O2|Outcome|Randomized: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
98945|NCT01980875|O1|Outcome|Safety Run-In: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
98946|NCT01980875|E3|Reported Event|Randomized: Obinutuzumab+Chlorambucil|Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
98947|NCT01980875|E2|Reported Event|Randomized: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
98948|NCT01980875|E1|Reported Event|Safety Run-In: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
98949|NCT01980628|B1|Baseline|Ibrutinib|Patients receive a daily dose of 560 mg of ibrutinib capsules
98950|NCT01980628|P1|Participant Flow|Ibrutinib|Patients receive daily dose of 560 mg of ibrutinib capsules.
98951|NCT01980628|O1|Outcome|Ibrutinib|Patients receive daily dose of 560 mg of ibrutinib capsules.
98952|NCT01980628|O1|Outcome|Single Arm, Intent to Treat Population|
98953|NCT01980628|E1|Reported Event|Ibrutinib|"ibrutinib capsules: 560 mg once daily~ibrutinib"
98954|NCT01980589|B4|Baseline|Total|Total of all reporting groups
98955|NCT01980589|B3|Baseline|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
98956|NCT01980589|B2|Baseline|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
98957|NCT01980589|B1|Baseline|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
98958|NCT01980589|P3|Participant Flow|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
98959|NCT01980589|P2|Participant Flow|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
98960|NCT01980589|P1|Participant Flow|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
98961|NCT01980589|O3|Outcome|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
98962|NCT01980589|O2|Outcome|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
98963|NCT01980589|O1|Outcome|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
98964|NCT01980589|O3|Outcome|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
98965|NCT01980589|O2|Outcome|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
98966|NCT01980589|O1|Outcome|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
98967|NCT01980589|O3|Outcome|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
98968|NCT01980589|O2|Outcome|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
98969|NCT01980589|O1|Outcome|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
98970|NCT01980589|O3|Outcome|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
98971|NCT01980589|O2|Outcome|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
98972|NCT01980589|O1|Outcome|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
98973|NCT01980589|E3|Reported Event|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
98974|NCT01980589|E2|Reported Event|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
98975|NCT01980589|E1|Reported Event|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
98976|NCT01980524|B1|Baseline|All Study Participants|On study day 1 subjects received acipimox 250 mg or placebo at 0 and 180 minutes (randomized, controlled, single blinded); after a wash out period of at least two weeks on study day 2 i) subjects who received acipimox 250 mg on study day 1 were administered placebo at 0 and 180 minutes and ii) subjects who received placebo on study day 1 were administered acipimox 250 mg at 0 and 180 minutes (randomized, controlled, single blinded).
98977|NCT01980524|P2|Participant Flow|Placebo|Participants received a placebo capsule at 0 and 180 minutes on the first study day; after a wash out period of at least 2 weeks a second study day followed where they received a acipimox 250 mg at 0 and 180 minutes
98978|NCT01980524|P1|Participant Flow|Acipimox First|Participants received acipimox 250 mg at 0 and 180 minutes on the first study day; after a wash out period of at least 2 weeks a second study day followed where they received a placebo capsule at 0 and 180 minutes
98979|NCT01980524|O2|Outcome|Placebo|"1 capsule at 0 and 180 minutes (one day)~placebo"
98980|NCT01980524|O1|Outcome|Acipimox+|"250 mg at 0 and 180 minutes (one day)~acipimox"
98981|NCT01980524|O2|Outcome|Placebo|"1 capsule at 0 and 180 minutes (one day)~placebo"
98982|NCT01980524|O1|Outcome|Acipimox+|"250 mg at 0 and 180 minutes (one day)~acipimox"
98983|NCT01980524|O2|Outcome|Placebo|"1 capsule at 0 and 180 minutes (one day)~placebo"
98984|NCT01980524|O1|Outcome|Acipimox+|"250 mg at 0 and 180 minutes (one day)~acipimox"
98985|NCT01980524|E2|Reported Event|Acipimox-|"1 Tablet at 0 and 180 minutes (one day)~acipimox"
98986|NCT01980524|E1|Reported Event|Acipimox+|"250 mg at 0 and 180 minutes (one day)~acipimox"
99020|NCT01979952|O1|Outcome|Nintedanib|Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
99170|NCT01978314|O2|Outcome|Cohort 2|eGFR renal function 30-59 mL/min for stage 3, moderate CKD
98987|NCT01980342|B1|Baseline|Efavirenz|"Healthy, reproductive-age women using the etonogestrel contraceptive implant who will take a two-week course of efavirenz 400 mg orally each night.~Efavirenz: Healthy women who are using Nexplanon will be asked to take a 2-week course of reduced-dose efavirenz (400 mg daily)."
98988|NCT01980342|P1|Participant Flow|Efavirenz|"Healthy, reproductive-age women using the etonogestrel contraceptive implant who will take a two-week course of efavirenz 400 mg orally each night.~Efavirenz: Healthy women who are using Nexplanon will be asked to take a 2-week course of reduced-dose efavirenz (400 mg daily)."
98989|NCT01980342|O1|Outcome|Efavirenz|"Healthy, reproductive-age women using the etonogestrel contraceptive implant who will take a two-week course of efavirenz 400 mg orally each night.~Efavirenz: Healthy women who are using Nexplanon will be asked to take a 2-week course of reduced-dose efavirenz (400 mg daily)."
98990|NCT01980342|O1|Outcome|Efavirenz|"Healthy, reproductive-age women using the etonogestrel contraceptive implant who will take a two-week course of efavirenz 400 mg orally each night.~Efavirenz: Healthy women who are using Nexplanon will be asked to take a 2-week course of reduced-dose efavirenz (400 mg daily)."
98991|NCT01980342|O1|Outcome|Efavirenz|"Healthy, reproductive-age women using the etonogestrel contraceptive implant who will take a two-week course of efavirenz 400 mg orally each night.~Efavirenz: Healthy women who are using Nexplanon will be asked to take a 2-week course of reduced-dose efavirenz (400 mg daily)."
98992|NCT01980342|O1|Outcome|Efavirenz|"Healthy, reproductive-age women using the etonogestrel contraceptive implant who will take a two-week course of efavirenz 400 mg orally each night.~Efavirenz: Healthy women who are using Nexplanon will be asked to take a 2-week course of reduced-dose efavirenz (400 mg daily)."
98993|NCT01980342|O1|Outcome|Efavirenz|"Healthy, reproductive-age women using the etonogestrel contraceptive implant who will take a two-week course of efavirenz 400 mg orally each night.~Efavirenz: Healthy women who are using Nexplanon will be asked to take a 2-week course of reduced-dose efavirenz (400 mg daily)."
98994|NCT01980342|E1|Reported Event|Efavirenz|"Healthy, reproductive-age women using the etonogestrel contraceptive implant who will take a two-week course of efavirenz 400 mg orally each night.~Efavirenz: Healthy women who are using Nexplanon will be asked to take a 2-week course of reduced-dose efavirenz (400 mg daily)."
98995|NCT01980095|B3|Baseline|Total|Total of all reporting groups
98996|NCT01980095|B2|Baseline|Placebo|Capsules that look like the RHB-105 product but contain no active ingredient.
98997|NCT01980095|B1|Baseline|RHB-105|"RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule.~Total daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg."
98998|NCT01980095|P2|Participant Flow|Placebo|Capsules that look like the RHB-105 product but contain no active ingredient.
98999|NCT01980095|P1|Participant Flow|RHB-105|"RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule.~Total daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg"
99000|NCT01980095|O2|Outcome|Active Drug Eradication Failure Subjects|These patients failed h.pylori eradication on study drug (active) and were subsequently treated with standard of care therapy as per the investigator.
99001|NCT01980095|O1|Outcome|Placebo Subjects|These patients failed h.pylori eradication on study drug (placebo) and were subsequently treated with standard of care therapy as per the investigator
99002|NCT01980095|O2|Outcome|Placebo|"Capsules that look like the RHB-105 product but contain no active ingredient.~Placebo: Subjects will take 4 placebo capsules every 8 hours with food for 14 days."
99003|NCT01980095|O1|Outcome|RHB-105|"RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule.~Total daily dose of:~Rifabutin 150 mg~Amoxicillin 3000 mg~Omeprazole 120 mg"
99004|NCT01980095|E2|Reported Event|Placebo|Identical capsules that look like the RHB-105 product but contain no active ingredient.
99005|NCT01980095|E1|Reported Event|RHB-105|RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule. Total daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg.
99006|NCT01979952|B3|Baseline|Total|Total of all reporting groups
99007|NCT01979952|B2|Baseline|Placebo|Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
99008|NCT01979952|B1|Baseline|Nintedanib|Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
99009|NCT01979952|P2|Participant Flow|Placebo|Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
99010|NCT01979952|P1|Participant Flow|Nintedanib|Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
99011|NCT01979952|O2|Outcome|Placebo|Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
99012|NCT01979952|O1|Outcome|Nintedanib|Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
99013|NCT01979952|O2|Outcome|Placebo|Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
99014|NCT01979952|O1|Outcome|Nintedanib|Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
99015|NCT01979952|O2|Outcome|Placebo|Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
99016|NCT01979952|O1|Outcome|Nintedanib|Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
99017|NCT01979952|O2|Outcome|Placebo|Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
99018|NCT01979952|O1|Outcome|Nintedanib|Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
99019|NCT01979952|O2|Outcome|Placebo|Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
99021|NCT01979952|O2|Outcome|Placebo|Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
99022|NCT01979952|O1|Outcome|Nintedanib|Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
99023|NCT01979952|O2|Outcome|Placebo|Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
99024|NCT01979952|O1|Outcome|Nintedanib|Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
99025|NCT01979952|O2|Outcome|Placebo|Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
99026|NCT01979952|O1|Outcome|Nintedanib|Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
99027|NCT01979952|O2|Outcome|Placebo|Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
99028|NCT01979952|O1|Outcome|Nintedanib|Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
99029|NCT01979952|O2|Outcome|Placebo|Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
99030|NCT01979952|O1|Outcome|Nintedanib|Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
99031|NCT01979952|O2|Outcome|Placebo|Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
99032|NCT01979952|O1|Outcome|Nintedanib|Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
99033|NCT01979952|O2|Outcome|Placebo|Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
99034|NCT01979952|O1|Outcome|Nintedanib|Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
99035|NCT01979952|E2|Reported Event|Placebo|Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
99036|NCT01979952|E1|Reported Event|Nintedanib|Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
99037|NCT01979445|B3|Baseline|Total|Total of all reporting groups
99038|NCT01979445|B2|Baseline|Clopidogrel|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs on Day 1.~Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1 and 1.5 hrs after the initiation of cangrelor infusion and within 5 min after the discontinuation of the cangrelor infusion."
99039|NCT01979445|B1|Baseline|Prasugrel|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Prasugrel 60 mg was administered on Day 1 as a single oral dose 30 min on Day 1 after the discontinuation of cangrelor infusion."
99040|NCT01979445|P4|Participant Flow|Clopidogrel 1 Hr During Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1 hr following the initiation of cangrelor infusion."
99041|NCT01979445|P3|Participant Flow|Clopidogrel 1.5 Hrs During Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1.5 hrs following the initiation of cangrelor infusion."
99042|NCT01979445|P2|Participant Flow|Clopidogrel Within 5 Min After Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg was administered on Day 1 as a single oral dose within 5 min after the discontinuation of the cangrelor infusion (2 hrs after initiation of cangrelor infusion)."
99043|NCT01979445|P1|Participant Flow|Prasugrel 30 Min After Cangrelor|"Cangrelor intravenously (IV) was administered on Day 1 as a 30 microgram (μg)/kilogram (kg) bolus, followed by 4 μg/kg/minute (min) infusion for 2 hours (hrs).~Prasugrel 60 milligram (mg) was administered on Day 1 as a single oral dose 30 min after the discontinuation of cangrelor infusion (2.5 hrs after initiation of cangrelor infusion)."
99044|NCT01979445|O4|Outcome|Clopidogrel 1 Hr During Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1 hr following the initiation of cangrelor infusion."
99045|NCT01979445|O3|Outcome|Clopidogrel 1.5 Hrs During Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1.5 hrs following the initiation of cangrelor infusion."
99046|NCT01979445|O2|Outcome|Clopidogrel Within 5 Min After Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg was administered on Day 1 as a single oral dose within 5 min after the discontinuation of the cangrelor infusion (2 hrs after initiation of cangrelor infusion)."
99047|NCT01979445|O1|Outcome|Prasugrel 30 Min After Cangrelor|"Prasugrel 60 mg was administered on Day 1 as a single oral dose 30 min after the discontinuation of cangrelor infusion (2.5 hrs after initiation of cangrelor infusion).~Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs."
99048|NCT01979445|O4|Outcome|Clopidogrel 1 Hr During Cangrelor|"Clopidogrel 600 mg administered orally 1 hr following the initiation of cangrelor infusion.~Cangrelor IV was administered as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs on study Day 1."
99049|NCT01979445|O3|Outcome|Clopidogrel 1.5 Hrs During Cangrelor|"Clopidogrel 600 mg administered orally 1.5 hrs following the initiation of cangrelor infusion.~Cangrelor IV was administered as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs on study Day 1."
99050|NCT01979445|O2|Outcome|Clopidogrel Within 5 Min After Cangrelor|"Clopidogrel 600 mg was administered orally within 5 min after the discontinuation of the cangrelor infusion (2 hrs after initiation of cangrelor infusion).~Cangrelor IV was administered as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs on study Day 1."
99051|NCT01979445|O1|Outcome|Prasugrel 30 Min After Cangrelor|"Prasugrel 60 mg was administered orally 30 min after the discontinuation of cangrelor infusion (2.5 hrs after initiation of cangrelor infusion).~Cangrelor IV was administered as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs on study Day 1."
99052|NCT01979445|O4|Outcome|Clopidogrel 1 Hr During Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1 hr following the initiation of cangrelor infusion."
99053|NCT01979445|O3|Outcome|Clopidogrel 1.5 Hrs During Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg administered on Day 1 as a single oral dose 1.5 hrs following the initiation of cangrelor infusion."
99054|NCT01979445|O2|Outcome|Clopidogrel Within 5 Min Post Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg was administered on Day 1 as a single oral dose within 5 min after the discontinuation of the cangrelor infusion (2 hrs after initiation of cangrelor infusion)."
99055|NCT01979445|O1|Outcome|Prasugrel 30 Min After Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Prasugrel 60 mg was administered on Day 1 as a single oral dose 30 min after the discontinuation of cangrelor infusion (2.5 hrs after initiation of cangrelor infusion)."
99056|NCT01979445|O4|Outcome|Clopidogrel 1 Hr During Cangrelor|"Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1 hr following the initiation of cangrelor infusion.~Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs."
99057|NCT01979445|O3|Outcome|Clopidogrel 1.5 Hrs During Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1.5 hrs following the initiation of cangrelor infusion."
99058|NCT01979445|O2|Outcome|Clopidogrel Within 5 Min After Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg was administered on Day 1 as a single oral dose within 5 min after the discontinuation of the cangrelor infusion (2 hrs after initiation of cangrelor infusion)."
99059|NCT01979445|O1|Outcome|Prasugrel 30 Min After Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Prasugrel 60 mg was administered on Day 1 as a single oral dose 30 min after the discontinuation of cangrelor infusion (2.5 hrs after initiation of cangrelor infusion)."
99060|NCT01979445|O4|Outcome|Clopidogrel 1 Hr During Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1 hr following the initiation of cangrelor infusion."
99061|NCT01979445|O3|Outcome|Clopidogrel 1.5 Hrs During Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1.5 hrs following the initiation of cangrelor infusion."
99062|NCT01979445|O2|Outcome|Clopidogrel Within 5 Min After Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg was administered on Day 1 as a single oral dose within 5 min after the discontinuation of the cangrelor infusion (2 hrs after initiation of cangrelor infusion)."
99063|NCT01979445|O1|Outcome|Prasugrel 30 Min After Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Prasugrel 60 mg was administered on Day 1 as a single oral dose 30 min after the discontinuation of cangrelor infusion (2.5 hrs after initiation of cangrelor infusion)."
99064|NCT01979445|E4|Reported Event|Clopidogrel 1 Hr During Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg administered on Day 1 as a single oral dose 1 hr following the initiation of cangrelor infusion."
99065|NCT01979445|E3|Reported Event|Clopidogrel 1.5 Hrs During Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1.5 hrs following the initiation of cangrelor infusion."
99066|NCT01979445|E2|Reported Event|Clopidogrel Within 5 Min After Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Clopidogrel 600 mg was administered on Day 1 as a single oral dose within 5 min after the discontinuation of the cangrelor infusion (2 hrs after initiation of cangrelor infusion)."
99067|NCT01979445|E1|Reported Event|Prasugrel 30 Min After Cangrelor|"Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.~Prasugrel 60 mg was administered on Day 1 as a single oral dose 30 min after the discontinuation of cangrelor infusion (2.5 hrs after initiation of cangrelor infusion)."
99068|NCT01979276|B1|Baseline|ALL Patients|Pomalidomide, 4 mg by mouth daily on days 1-21 of 28 day cycle Dexamethasone, 40 mg by mouth on days 1, 8, 15, and 22 of 28 day cycle Romidepsin, IV on days 1 and 15 of 28 day cycle, dose level to be determined
99069|NCT01979276|P1|Participant Flow|ALL Patients|Pomalidomide, 4 mg by mouth daily on days 1-21 of 28 day cycle Dexamethasone, 40 mg by mouth on days 1, 8, 15, and 22 of 28 day cycle Romidepsin, IV on days 1 and 15 of 28 day cycle, dose level to be determined (9mg/m2, 12 mg/m2, 15 mg/m2 or 18 mg/m2)
99070|NCT01979276|O1|Outcome|ALL Patients|Pomalidomide, 4 mg by mouth daily on days 1-21 of 28 day cycle Dexamethasone, 40 mg by mouth on days 1, 8, 15, and 22 of 28 day cycle Romidepsin, IV on days 1 and 15 of 28 day cycle, dose level to be determined
99071|NCT01979276|O1|Outcome|ALL Patients|Pomalidomide, 4 mg by mouth daily on days 1-21 of 28 day cycle Dexamethasone, 40 mg by mouth on days 1, 8, 15, and 22 of 28 day cycle Romidepsin, IV on days 1 and 15 of 28 day cycle, dose level to be determined
99072|NCT01979276|O1|Outcome|ALL Patients|Pomalidomide, 4 mg by mouth daily on days 1-21 of 28 day cycle Dexamethasone, 40 mg by mouth on days 1, 8, 15, and 22 of 28 day cycle Romidepsin, IV on days 1 and 15 of 28 day cycle, dose level to be determined
99073|NCT01979276|E1|Reported Event|Pomalidomide, Romidepsin, Dexamethasone|"Pomalidomide, 4 mg by mouth daily on days 1-21 of 28 day cycle Dexamethasone, 40 mg by mouth on days 1, 8, 15, and 22 of 28 day cycle Romidepsin, IV on days 1 and 15 of 28 day cycle, dose level to be determined Dexamethasone~Romidepsin: Romidepsin intravenously on days 1 and 15 of a 28-day cycle~pomalidomide: Pomalidomide 4mg daily by mouth on days 1-21 of a 28-day cycle~Dexamethasone: Dexamethasone 40mg by mouth on days 1, 8, 15 and 22 of a 28-day cycle"
99074|NCT01979185|B3|Baseline|Total|Total of all reporting groups
99075|NCT01979185|B2|Baseline|Simvastatin + SSP-004184SS First|Subjects received Simvastatin 20mg and SSP-004184SS 30mg/kg in Period 1, followed by Simvastatin 20mg during Period 2.
99076|NCT01979185|B1|Baseline|Simvastatin First|Subjects received Simvastatin 20mg in Period 1, followed by Simvastatin 20mg and SSP-004184SS 30mg/kg during Period 2.
99077|NCT01979185|P2|Participant Flow|Simvastatin + SSP-004184SS First|Subjects received Simvastatin 20mg and SSP-004184SS 30mg/kg in Period 1, followed by Simvastatin 20mg during Period 2.
99078|NCT01979185|P1|Participant Flow|Simvastatin First|Subjects received Simvastatin 20mg in Period 1, followed by Simvastatin 20mg and SSP-004184SS 30mg/kg during Period 2.
99079|NCT01979185|O2|Outcome|Simvastatin + SSP-004184SS|Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
99080|NCT01979185|O1|Outcome|Simvastatin Alone|Administered as a single oral 20 mg dose on Day 1.
99081|NCT01979185|O2|Outcome|Simvastatin + SSP-004184SS|Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
99082|NCT01979185|O1|Outcome|Simvastatin Alone|Administered as a single oral 20 mg dose on Day 1.
99083|NCT01979185|O2|Outcome|Simvastatin + SSP-004184SS|Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
99084|NCT01979185|O1|Outcome|Simvastatin Alone|Administered as a single oral 20 mg dose on Day 1.
99085|NCT01979185|E2|Reported Event|Simvastatin + SSP-004184SS|Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
99086|NCT01979185|E1|Reported Event|Simvastatin Alone|Administered as a single oral 20 mg dose on Day 1.
99087|NCT01979133|B1|Baseline|Icariin|"Icariin will be given 100 mg/day. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 for participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen.~Icariin: Participants will receive 20% icariin (100 mg/day) in a commercially available over-the-counter Horny Goat Weed supplement. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen."
99088|NCT01979133|P1|Participant Flow|Icariin|"Icariin will be given 100 mg/day. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 for participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen.~Icariin: Participants will receive 20% icariin (100 mg/day) in a commercially available over-the-counter Horny Goat Weed supplement. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen."
99089|NCT01979133|O2|Outcome|Week 8|Week 8 YMRS Score
99090|NCT01979133|O1|Outcome|Baseline|Baseline YMRS Score
99091|NCT01979133|O2|Outcome|Week 8|Week 8 Days of alcohol use per week
99092|NCT01979133|O1|Outcome|Baseline|Baseline Days of alcohol use per week
99093|NCT01979133|O2|Outcome|Week 8|Week 8 Heavy Drinking Days Per Week
99094|NCT01979133|O1|Outcome|Baseline|Baseline Heavy Drinking Days Per Week
99095|NCT01979133|O2|Outcome|Week 8|Week 8 Mean Standard Drinks Per Week
99096|NCT01979133|O1|Outcome|Baseline|Baseline Mean Standard Drinks Per Week
99097|NCT01979133|O2|Outcome|Week 8|Week 8 QIDS Score
99098|NCT01979133|O1|Outcome|Baseline|Baseline QIDS Score
99099|NCT01979133|O2|Outcome|Week 8|Week 8 HAMA Score
99100|NCT01979133|O1|Outcome|Baseline|Baseline HAMA Score
99101|NCT01979133|O2|Outcome|Week 8|Week 8 HAMD Score
99102|NCT01979133|O1|Outcome|Baseline|Baseline HAMD Score
99103|NCT01979133|E1|Reported Event|Icariin|"Icariin will be given 100 mg/day. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 for participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen.~Icariin: Participants will receive 20% icariin (100 mg/day) in a commercially available over-the-counter Horny Goat Weed supplement. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen."
99104|NCT01979029|B3|Baseline|Total|Total of all reporting groups
99105|NCT01979029|B2|Baseline|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.~preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
99106|NCT01979029|B1|Baseline|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.~not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
99167|NCT01978314|O5|Outcome|Cohort 5|eGFR renal function ≥60 mL/min for normal function
99107|NCT01979029|P2|Participant Flow|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.~preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
99108|NCT01979029|P1|Participant Flow|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.~not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
99109|NCT01979029|O2|Outcome|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.~preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
99110|NCT01979029|O1|Outcome|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.~not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
99111|NCT01979029|O2|Outcome|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.~preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
99112|NCT01979029|O1|Outcome|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.~not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
99113|NCT01979029|O2|Outcome|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.~preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
99114|NCT01979029|O1|Outcome|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.~not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
99115|NCT01979029|E2|Reported Event|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.~preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
99116|NCT01979029|E1|Reported Event|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.~not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
99117|NCT01978743|B1|Baseline|Raltegravir|All 10 participants were switched from Atripla to twice daily Raltegravir and Truvada (FTC/TDF)
99118|NCT01978743|P1|Participant Flow|Raltegravir|"All participants are switched from Atripla (EFV/FTC/TDF) to raltegravir (RAL) + truvada (FTC/TDF).~Raltegravir will be administered 400mg twice-a-day."
99119|NCT01978743|O1|Outcome|Raltegravir|All 10 participants were switched from Atripla to twice daily Raltegravir and Truvada (FTC/TDF)
99120|NCT01978743|O1|Outcome|Raltegravir|All 10 participants were switched from Atripla to twice daily Raltegravir and Truvada (FTC/TDF)
99121|NCT01978743|O1|Outcome|Raltegravir|All 10 participants were switched from Atripla to twice daily Raltegravir and Truvada (FTC/TDF)
99122|NCT01978743|O1|Outcome|Raltegravir|All 10 participants were switched from Atripla to twice daily Raltegravir and Truvada (FTC/TDF)
99123|NCT01978743|O1|Outcome|Raltegravir|All 10 participants were switched from Atripla to twice daily Raltegravir and Truvada (FTC/TDF)
99124|NCT01978743|O1|Outcome|Raltegravir|"Switch from Atripla (EFV/FTC/TDF) to raltegravir (RAL) + Truvada (FTC/TDF). Raltegravir will be administered 400mg twice-a-day with Truvada for 8 weeks.~Drug switch from Atripla: Switch from Atripla to Raltegravir 400mg BID + Truvada (FTC/TDF) for total of 8 weeks"
99125|NCT01978743|O1|Outcome|Raltegravir|"Switch from Atripla (EFV/FTC/TDF) to raltegravir (RAL) + Truvada (FTC/TDF). Raltegravir will be administered 400mg twice-a-day with Truvada for 8 weeks.~Drug switch from Atripla: Switch from Atripla to Raltegravir 400mg BID + Truvada (FTC/TDF) for total of 8 weeks"
99126|NCT01978743|O1|Outcome|Raltegravir|"Switch from Atripla (EFV/FTC/TDF) to raltegravir (RAL) + Truvada (FTC/TDF). Raltegravir will be administered 400mg twice-a-day with Truvada for 8 weeks.~Drug switch from Atripla: Switch from Atripla to Raltegravir 400mg BID + Truvada (FTC/TDF) for total of 8 weeks"
99127|NCT01978743|O1|Outcome|Raltegravir|"Switch from Atripla (EFV/FTC/TDF) to raltegravir (RAL) + Truvada (FTC/TDF). Raltegravir will be administered 400mg twice-a-day with Truvada for 8 weeks.~Drug switch from Atripla: Switch from Atripla to Raltegravir 400mg BID + Truvada (FTC/TDF) for total of 8 weeks"
99128|NCT01978743|E1|Reported Event|Raltegravir|All 10 participants were switched from Atripla to twice daily Raltegravir and Truvada (FTC/TDF)
99129|NCT01978600|B3|Baseline|Total|Total of all reporting groups
99130|NCT01978600|B2|Baseline|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
99131|NCT01978600|B1|Baseline|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
99132|NCT01978600|P2|Participant Flow|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
99133|NCT01978600|P1|Participant Flow|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
99134|NCT01978600|O2|Outcome|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
99135|NCT01978600|O1|Outcome|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
99136|NCT01978600|O2|Outcome|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
99137|NCT01978600|O1|Outcome|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
99138|NCT01978600|O2|Outcome|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
99139|NCT01978600|O1|Outcome|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
99140|NCT01978600|E2|Reported Event|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
99141|NCT01978600|E1|Reported Event|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
99142|NCT01978535|B3|Baseline|Total|Total of all reporting groups
99143|NCT01978535|B2|Baseline|Normal Saline Infusion|Normal saline infusion: Normal saline (NaCl 0.9%) 5 mL/kg up to a maximum volume 210 mL
99144|NCT01978535|B1|Baseline|Iron Infusion|Iron infusion: 5 mg/kg of intravenous iron sucrose supplied as Venofer (TM) with a maximum dose of 200mg. Iron sucrose will be diluted to 1 mg of elemental iron in 1 mL of NaCl 0.9% with a maximum volume of 210 mL.
99145|NCT01978535|P2|Participant Flow|Normal Saline Infusion|Normal saline infusion: Normal saline (NaCl 0.9%) 5 mL/kg up to a maximum volume 210 mL
99146|NCT01978535|P1|Participant Flow|Iron Infusion|Iron infusion: 5 mg/kg of intravenous iron sucrose supplied as Venofer (TM) with a maximum dose of 200mg. Iron sucrose will be diluted to 1 mg of elemental iron in 1 mL of NaCl 0.9% with a maximum volume of 210 mL.
99147|NCT01978535|O2|Outcome|Normal Saline Infusion|Normal saline infusion: Normal saline (NaCl 0.9%) 5 mL/kg up to a maximum volume 210 mL
99148|NCT01978535|O1|Outcome|Iron Infusion|Iron infusion: 5 mg/kg of intravenous iron sucrose supplied as Venofer (TM) with a maximum dose of 200mg. Iron sucrose will be diluted to 1 mg of elemental iron in 1 mL of NaCl 0.9% with a maximum volume of 210 mL.
99149|NCT01978535|E2|Reported Event|Normal Saline Infusion|Normal saline infusion: Normal saline (NaCl 0.9%) 5 mL/kg up to a maximum volume 210 mL
99150|NCT01978535|E1|Reported Event|Iron Infusion|Iron infusion: 5 mg/kg of intravenous iron sucrose supplied as Venofer (TM) with a maximum dose of 200mg. Iron sucrose will be diluted to 1 mg of elemental iron in 1 mL of NaCl 0.9% with a maximum volume of 210 mL.
99151|NCT01978314|B6|Baseline|Total|Total of all reporting groups
99152|NCT01978314|B5|Baseline|Cohort 5|"Estimated GFR (mL/min)~≥60 mL/min/1.73m2 BSA"
99153|NCT01978314|B4|Baseline|Cohort 4|Estimated GFR (mL/min) sCr: ≥2-fold increase or eGFR: >50% decrease compared to baseline
99154|NCT01978314|B3|Baseline|Cohort 3|Estimated GFR (mL/min) 15-29 mL/min/1.73m2 BSA
99155|NCT01978314|B2|Baseline|Cohort 2|Estimated GFR (mL/min) 30-59 mL/min/1.73m2 BSA
99156|NCT01978314|B1|Baseline|Cohort 1|"Estimated GFR (mL/min)~≥60 mL/min/1.73m2 BSA"
99157|NCT01978314|P5|Participant Flow|Cohort 5|eGFR renal function ≥60 mL/min for normal function
99158|NCT01978314|P4|Participant Flow|Cohort 4|a diagnosis of either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI
99159|NCT01978314|P3|Participant Flow|Cohort 3|eGFR renal function 15-29 mL/min for stage 4, severe CKD
99160|NCT01978314|P2|Participant Flow|Cohort 2|eGFR renal function 30-59 mL/min for stage 3, moderate CKD
99161|NCT01978314|P1|Participant Flow|Cohort 1|eGFR renal function ≥60 mL/min for normal function
99162|NCT01978314|O5|Outcome|Cohort 5|"eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol~75 mg / 6 mL VFI™: Visible fluorescent injectate, a mixture of two different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached."
99163|NCT01978314|O4|Outcome|Cohort 4|"a diagnosis of either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI 75 mg / 6mL VFI™ and 5mL of Iohexol~75 mg / 6 mL VFI™: Visible fluorescent injectate, a mixture of two different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached."
99164|NCT01978314|O3|Outcome|Cohort 3|"eGFR renal function 15-29 mL/min for stage 4, severe CKD 75 mg / 6mL VFI™ and 5mL of Iohexol~75 mg / 6 mL VFI™: Visible fluorescent injectate, a mixture of two different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached."
99165|NCT01978314|O2|Outcome|Cohort 2|"eGFR renal function 30-59 mL/min for stage 3, moderate CKD 75 mg / 6mL VFI™ and 5mL of Iohexol~75 mg / 6 mL VFI™: Visible fluorescent injectate, a mixture of two different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached."
99166|NCT01978314|O1|Outcome|Cohort 1|"eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol~75 mg / 6 mL VFI™: Visible fluorescent injectate, a mixture of two different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached."
99172|NCT01978314|O5|Outcome|Cohort 5|eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol
99173|NCT01978314|O4|Outcome|Cohort 4|a diagnosis of either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI 75 mg / 6mL VFI™ and 5mL of Iohexol
99174|NCT01978314|O3|Outcome|Cohort 3|eGFR renal function 15-29 mL/min for stage 4, severe CKD 75 mg / 6mL VFI™ and 5mL of Iohexol
99175|NCT01978314|O2|Outcome|Cohort 2|eGFR renal function 30-59 mL/min for stage 3, moderate CKD 75 mg / 6mL VFI™ and 5mL of Iohexol
99176|NCT01978314|O1|Outcome|Cohort 1|eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol
99177|NCT01978314|O5|Outcome|Cohort 5|eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol
99178|NCT01978314|O4|Outcome|Cohort 4|a diagnosis of either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI 75 mg / 6mL VFI™ and 5mL of Iohexol
99179|NCT01978314|O3|Outcome|Cohort 3|eGFR renal function 15-29 mL/min for stage 4, severe CKD 75 mg / 6mL VFI™ and 5mL of Iohexol
99180|NCT01978314|O2|Outcome|Cohort 2|eGFR renal function 30-59 mL/min for stage 3, moderate CKD 75 mg / 6mL VFI™ and 5mL of Iohexol
99181|NCT01978314|O1|Outcome|Cohort 1|eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol
99182|NCT01978314|O5|Outcome|Cohort 5|eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol
99183|NCT01978314|O4|Outcome|Cohort 4|a diagnosis of either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI 75 mg / 6mL VFI™ and 5mL of Iohexol
99184|NCT01978314|O3|Outcome|Cohort 3|eGFR renal function 15-29 mL/min for stage 4, severe CKD 75 mg / 6mL VFI™ and 5mL of Iohexol
99185|NCT01978314|O2|Outcome|Cohort 2|eGFR renal function 30-59 mL/min for stage 3, moderate CKD 75 mg / 6mL VFI™ and 5mL of Iohexol
99186|NCT01978314|O1|Outcome|Cohort 1|eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol
99187|NCT01978314|O5|Outcome|Cohort 5|eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol
99188|NCT01978314|O4|Outcome|Cohort 4|a diagnosis of either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI 75 mg / 6mL VFI™ and 5mL of Iohexol
99189|NCT01978314|O3|Outcome|Cohort 3|eGFR renal function 15-29 mL/min for stage 4, severe CKD 75 mg / 6mL VFI™ and 5mL of Iohexol
99190|NCT01978314|O2|Outcome|Cohort 2|eGFR renal function 30-59 mL/min for stage 3, moderate CKD 75 mg / 6mL VFI™ and 5mL of Iohexol
99191|NCT01978314|O1|Outcome|Cohort 1|eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol
99192|NCT01978314|O5|Outcome|Cohort 5|eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol
99193|NCT01978314|O4|Outcome|Cohort 4|a diagnosis of either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI 75 mg / 6mL VFI™ and 5mL of Iohexol
99194|NCT01978314|O3|Outcome|Cohort 3|eGFR renal function 15-29 mL/min for stage 4, severe CKD 75 mg / 6mL VFI™ and 5mL of Iohexol
99195|NCT01978314|O2|Outcome|Cohort 2|eGFR renal function 30-59 mL/min for stage 3, moderate CKD 75 mg / 6mL VFI™ and 5mL of Iohexol
99196|NCT01978314|O1|Outcome|Cohort 1|eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol
99197|NCT01978314|O5|Outcome|Cohort 5|eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol
99198|NCT01978314|O4|Outcome|Cohort 4|a diagnosis of either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI 75 mg / 6mL VFI™ and 5mL of Iohexol
99199|NCT01978314|O3|Outcome|Cohort 3|eGFR renal function 15-29 mL/min for stage 4, severe CKD 75 mg / 6mL VFI™ and 5mL of Iohexol
99200|NCT01978314|O2|Outcome|Cohort 2|eGFR renal function 30-59 mL/min for stage 3, moderate CKD 75 mg / 6mL VFI™ and 5mL of Iohexol
99201|NCT01978314|O1|Outcome|Cohort 1|eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol
99202|NCT01978314|O5|Outcome|Cohort 5|eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol
99203|NCT01978314|O4|Outcome|Cohort 4|a diagnosis of either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI 75 mg / 6mL VFI™ and 5mL of Iohexol
99204|NCT01978314|O3|Outcome|Cohort 3|eGFR renal function 15-29 mL/min for stage 4, severe CKD 75 mg / 6mL VFI™ and 5mL of Iohexol
99205|NCT01978314|O2|Outcome|Cohort 2|eGFR renal function 30-59 mL/min for stage 3, moderate CKD 75 mg / 6mL VFI™ and 5mL of Iohexol
99206|NCT01978314|O1|Outcome|Cohort 1|eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol
99207|NCT01978314|O5|Outcome|Cohort 5|eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol
99208|NCT01978314|O4|Outcome|Cohort 4|a diagnosis of either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI 75 mg / 6mL VFI™ and 5mL of Iohexol
99209|NCT01978314|O3|Outcome|Cohort 3|eGFR renal function 15-29 mL/min for stage 4, severe CKD 75 mg / 6mL VFI™ and 5mL of Iohexol
99210|NCT01978314|O2|Outcome|Cohort 2|eGFR renal function 30-59 mL/min for stage 3, moderate CKD 75 mg / 6mL VFI™ and 5mL of Iohexol
99211|NCT01978314|O1|Outcome|Cohort 1|eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol
99212|NCT01978314|O5|Outcome|Cohort 5|eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol
99213|NCT01978314|O4|Outcome|Cohort 4|a diagnosis of either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI 75 mg / 6mL VFI™ and 5mL of Iohexol
99214|NCT01978314|O3|Outcome|Cohort 3|eGFR renal function 15-29 mL/min for stage 4, severe CKD 75 mg / 6mL VFI™ and 5mL of Iohexol
99215|NCT01978314|O2|Outcome|Cohort 2|eGFR renal function 30-59 mL/min for stage 3, moderate CKD 75 mg / 6mL VFI™ and 5mL of Iohexol
99216|NCT01978314|O1|Outcome|Cohort 1|eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol
99217|NCT01978314|O5|Outcome|Cohort 5|eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol
99218|NCT01978314|O4|Outcome|Cohort 4|a diagnosis of either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI 75 mg / 6mL VFI™ and 5mL of Iohexol
99219|NCT01978314|O3|Outcome|Cohort 3|eGFR renal function 15-29 mL/min for stage 4, severe CKD 75 mg / 6mL VFI™ and 5mL of Iohexol
99220|NCT01978314|O2|Outcome|Cohort 2|eGFR renal function 30-59 mL/min for stage 3, moderate CKD 75 mg / 6mL VFI™ and 5mL of Iohexol
99221|NCT01978314|O1|Outcome|Cohort 1|eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol
99222|NCT01978314|O5|Outcome|Cohort 5|eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol
99223|NCT01978314|O4|Outcome|Cohort 4|a diagnosis of either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI 75 mg / 6mL VFI™ and 5mL of Iohexol
99224|NCT01978314|O3|Outcome|Cohort 3|eGFR renal function 15-29 mL/min for stage 4, severe CKD 75 mg / 6mL VFI™ and 5mL of Iohexol
99225|NCT01978314|O2|Outcome|Cohort 2|eGFR renal function 30-59 mL/min for stage 3, moderate CKD 75 mg / 6mL VFI™ and 5mL of Iohexol
99226|NCT01978314|O1|Outcome|Cohort 1|eGFR renal function ≥60 mL/min for normal function 75 mg / 6mL VFI™ and 5mL of Iohexol
99227|NCT01978314|O5|Outcome|Cohort 5|eGFR renal function ≥60 mL/min for normal function
99228|NCT01978314|O4|Outcome|Cohort 4|sCr: ≥2-fold increase or eGFR: >50% decrease compared to baseline
99229|NCT01978314|O3|Outcome|Cohort 3|eGFR renal function 15-29 mL/min for stage 4, severe CKD
99230|NCT01978314|O2|Outcome|Cohort 2|eGFR renal function 30-59 mL/min for stage 3, moderate CKD
99231|NCT01978314|O1|Outcome|Cohort 1|eGFR renal function ≥60 mL/min for normal function
99232|NCT01978314|O5|Outcome|Cohort 5|eGFR renal function ≥60 mL/min for normal function
99233|NCT01978314|O4|Outcome|Cohort 4|sCr: ≥2-fold increase or eGFR: >50% decrease compared to baseline
99234|NCT01978314|O3|Outcome|Cohort 3|eGFR renal function 15-29 mL/min for stage 4, severe CKD
99235|NCT01978314|O2|Outcome|Cohort 2|eGFR renal function 30-59 mL/min for stage 3, moderate CKD
99236|NCT01978314|O1|Outcome|Cohort 1|eGFR renal function ≥60 mL/min for normal function
99237|NCT01978314|E5|Reported Event|Cohort 5|eGFR renal function ≥60 mL/min for normal function
99238|NCT01978314|E4|Reported Event|Cohort 4|a diagnosis of either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI
99239|NCT01978314|E3|Reported Event|Cohort 3|eGFR renal function 15-29 mL/min for stage 4, severe CKD
99240|NCT01978314|E2|Reported Event|Cohort 2|eGFR renal function 30-59 mL/min for stage 3, moderate CKD
99241|NCT01978314|E1|Reported Event|Cohort 1|eGFR renal function ≥60 mL/min for normal function
99242|NCT01978145|B1|Baseline|Overall Study|All participants received one of the following 2 treatments in each of the two 12-week treatment periods separated by a 4-week washout period. One inhalation of FSC (250/50 mcg) self administered twice daily (BID) (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI or one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI . Salbutamol/albuterol was provided to use as rescue medication.
99243|NCT01978145|P2|Participant Flow|Sequence 2: FSC MD DPI/Pl CB DPI Then Pl MD DPI/FSC CB DPI|Participants self administered one inhalation of FSC (250/50 mcg) via a MD DPI and one inhalation of Placebo via a CB DPI in the morning and evening in Treatment Period 1 for 12 weeks. After washout period of 4 weeks, participants self admnistered one inhalation of matching Placebo via a MD DPI and one inhalation of FSC (250/50 mcg) via a CB DPI in the morning and evening in Treatment Period 2 for 12 weeks. Salbutamol/albuterol was provided to use as rescue medication.
99244|NCT01978145|P1|Participant Flow|Sequence 1: Pl MD DPI/FSC CB DPI Then FSC MD DPI/Pl CB DPI|Participants self administered one inhalation of matching Placebo (Pl) via a multi-dose dry powder inhaler (MD DPI) followed by one inhalation of single capsule containing Fluticasone propionate and salmeterol combination (FSC) (250/50 microgram [mcg]) via a capsule-based unit dose (CB) DPI in the morning and evening in the Treatment Period 1 for 12 weeks. After washout period of 4 weeks, participants self administered one inhalation of FSC (250/50 mcg) via the MD DPI and one inhalation of of matching Placebo via the capsule-based unit dose DPI in the morning and evening in Treatment Period 2 for 12 weeks. Salbutamol/albuterol was provided to use as rescue medication
99245|NCT01978145|O2|Outcome|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
99246|NCT01978145|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
99247|NCT01978145|O2|Outcome|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
99248|NCT01978145|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
99249|NCT01978145|O2|Outcome|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
99250|NCT01978145|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
99348|NCT01977690|E2|Reported Event|Clavicle Brace Wearing|"Patient has to wear clavicle brace for one month.~Clavicle Brace"
99349|NCT01977690|E1|Reported Event|Standard Management|Patients received analgesic ad libitum
100848|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
99251|NCT01978145|O2|Outcome|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
99252|NCT01978145|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
99253|NCT01978145|O2|Outcome|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
99254|NCT01978145|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
99255|NCT01978145|O2|Outcome|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
99256|NCT01978145|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
99257|NCT01978145|E2|Reported Event|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
99258|NCT01978145|E1|Reported Event|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
99259|NCT01978119|B1|Baseline|Overall Study|All participants received one of the following 2 treatments in each of the two 12-week treatment periods separated by a 3-week washout period. One actuations of FSC (250/50 mcg) self administered twice daily (BID) (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI or one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI. Salbutamol/albuterol was provided to use as rescue medication.
99260|NCT01978119|P2|Participant Flow|Sequence 2: FSC MD-DPI/Pl CB-DPI Then Pl MD-DPI/FSC CB-DPI|Participants self administered one inhalation of FSC (250/50 mcg) via a multi-dose DPI and one inhalation of Placebo via a capsule-based unit dose DPI in the morning and evening in Treatment Period 1 for 12 weeks. After washout period of 3 weeks participants self admnistered one inhalation of matching Placebo via a multi-dose DPI and one inhalation of FSC (250/50 mcg) via a capsule-based unit dose DPI in the morning and evening in Treatment Period 2 for 12 weeks. Salbutamol/albuterol was provided to use as rescue medication.
99261|NCT01978119|P1|Participant Flow|Sequence 1: Pl MD-DPI/FSC CB-DPI Then FSC MD-DPI/Pl CB-DPI|Participants self administered one inhalation of matching Placebo (Pl) via a multi-dose dry powder inhaler (MD DPI) and one inhalation of single capsule containing Fluticasone salmeterol combination (FSC) (250/50 microgram [mcg]) via a capsule-based unit dose (CB) DPI in the morning and evening in the Treatment Period 1 for 12 weeks. After washout period of 3 weeks participants self administered one inhalation of FSC (250/50 mcg) via the multi-dose DPI and one inhalation of of matching Placebo via the capsule-based unit dose DPI in the morning and evening in Treatment Period 2 for 12 weeks. Salbutamol/albuterol was provided to use as rescue medication.
99262|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
99263|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
99264|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
99265|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
99350|NCT01977625|B1|Baseline|All Participants|Participants first received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks followed by a 2-week washout, then they received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.
99266|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
99267|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
99268|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
99269|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
99270|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
99271|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
99272|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
99273|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
99274|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
99275|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
99276|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
99277|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
99278|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
99279|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
99280|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
99281|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
99351|NCT01977625|P2|Participant Flow|Placebo, Then Lisdexamfetamine|Participants first received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks followed by a 2-week washout, then they received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks..
99282|NCT01978119|E2|Reported Event|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
99283|NCT01978119|E1|Reported Event|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
99284|NCT01977820|B3|Baseline|Total|Total of all reporting groups
99285|NCT01977820|B2|Baseline|Placebo|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive placebo tablets matching to sapropterin orally once daily during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
99286|NCT01977820|B1|Baseline|Sapropterin|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive sapropterin during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
99287|NCT01977820|P2|Participant Flow|Placebo|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive placebo tablets matching to sapropterin orally once daily during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
99288|NCT01977820|P1|Participant Flow|Sapropterin|Subject was administered with 20 milligram per kilogram (mg/kg) sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive sapropterin during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
99289|NCT01977820|O2|Outcome|Placebo|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive placebo tablets matching to sapropterin orally once daily during the 24-week study period. The subject completed the study according to the study protocol until the study was terminated by the Sponsor.
99290|NCT01977820|O1|Outcome|Sapropterin|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive sapropterin during the 24-week study period. The subject completed the study according to the study protocol until the study was terminated by the Sponsor.
99291|NCT01977820|E2|Reported Event|Placebo|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive placebo tablets matching to sapropterin orally once daily during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
99292|NCT01977820|E1|Reported Event|Sapropterin|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive sapropterin during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
99293|NCT01977794|B3|Baseline|Total|Total of all reporting groups
99294|NCT01977794|B2|Baseline|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
99295|NCT01977794|B1|Baseline|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
99311|NCT01977781|B2|Baseline|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Methylprednisolone Sodium Succinate"
99536|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99296|NCT01977794|P2|Participant Flow|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5mg/10mg or 10mg/5mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/5mg dose and Bisoprolol/Amlodipine and 10mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18 (Day 127). Controlled BP = SBP <140 mmHg and DBP <90 mmHg.
99297|NCT01977794|P1|Participant Flow|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 milligram (mg) before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine fixed dose combination(FDC) tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at initial dose of 5mg/5mg once daily for 6 weeks.If blood pressure (BP) was controlled at Week 6(Day 43),same dose continued for next 6 weeks. If BP was not controlled at Day 43,dose was increased to Bisoprolol/Amlodipine 5mg/10mg or 10mg/5mg for next 6 weeks.Subjects who had controlled BP atWeek 12(Day 85),continued same dose that they were receiving for next 6 weeks. If BP was not controlled at Day 85,dose was increased to next level,(Bisoprolol/Amlodipine 5mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/5mg dose and Bisoprolol/Amlodipine 10mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18(Day 127).Controlled BP=Systolic BP(SBP)<140 millimetre of mercury(mmHg) and Diastolic BP(DBP)<90mmHg.
99298|NCT01977794|O2|Outcome|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
99299|NCT01977794|O1|Outcome|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
99300|NCT01977794|O2|Outcome|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
99301|NCT01977794|O1|Outcome|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
99302|NCT01977794|O2|Outcome|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
99312|NCT01977781|B1|Baseline|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Tacrolimus"
99303|NCT01977794|O1|Outcome|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
99304|NCT01977794|O2|Outcome|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
99305|NCT01977794|O1|Outcome|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
99306|NCT01977794|O2|Outcome|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
99307|NCT01977794|O1|Outcome|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
99308|NCT01977794|E2|Reported Event|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
99309|NCT01977794|E1|Reported Event|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
99310|NCT01977781|B3|Baseline|Total|Total of all reporting groups
99343|NCT01977690|B1|Baseline|Standard Management|Every patient routinely received narcotic and non-narcotic pain medication on an as-needed basis in the hospital. No nonsteroidal anti-inflammatory drugs, such as ibuprofen or ketorolac, were given.
99344|NCT01977690|P2|Participant Flow|Clavicle Brace Wearing|"Patient has to wear clavicle brace for one month.~Clavicle Brace"
99345|NCT01977690|P1|Participant Flow|Standard Management|Patients received analgesics ad libitum
100849|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
99313|NCT01977781|P2|Participant Flow|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Methylprednisolone Sodium Succinate"
99314|NCT01977781|P1|Participant Flow|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Tacrolimus"
99315|NCT01977781|O2|Outcome|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Methylprednisolone Sodium Succinate"
99316|NCT01977781|O1|Outcome|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Tacrolimus"
99317|NCT01977781|O2|Outcome|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Methylprednisolone Sodium Succinate"
99318|NCT01977781|O1|Outcome|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Tacrolimus"
99319|NCT01977781|O2|Outcome|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Methylprednisolone Sodium Succinate"
99320|NCT01977781|O1|Outcome|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Tacrolimus"
99321|NCT01977781|O2|Outcome|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Methylprednisolone Sodium Succinate"
99322|NCT01977781|O1|Outcome|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Tacrolimus"
99323|NCT01977781|O2|Outcome|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Methylprednisolone Sodium Succinate"
99346|NCT01977690|O2|Outcome|Clavicle Brace Wearing|"Patient has to wear clavicle brace for one month.~Clavicle Brace"
99324|NCT01977781|O1|Outcome|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Tacrolimus"
99325|NCT01977781|O2|Outcome|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Methylprednisolone Sodium Succinate"
99326|NCT01977781|O1|Outcome|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Tacrolimus"
99327|NCT01977781|O2|Outcome|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Methylprednisolone Sodium Succinate"
99328|NCT01977781|O1|Outcome|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Tacrolimus"
99329|NCT01977781|E2|Reported Event|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Methylprednisolone Sodium Succinate"
99330|NCT01977781|E1|Reported Event|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Tacrolimus"
99331|NCT01977729|B1|Baseline|All Study Participants|
99332|NCT01977729|P1|Participant Flow|All Participants|Only one participant was recruited, but never randomized.
99333|NCT01977729|O2|Outcome|Switch to SRT Alone|"Sertraline: Medication will be administered daily using a fixed-flexible strategy beginning at 25mg, titrating to 200mg across 8 wks (i.e., wks 9-17). We expect patients' medication dose will be adjusted upward in 50 mg/day increments if clinician-rated CGI-S anxiety severity is 3 (mild) or greater."
99334|NCT01977729|O1|Outcome|CBT With SRT|CBT (Cognitive Behavioral Therapy)+SRT (Sertraline) will be scheduled at weeks 9-12, 14, 16, 18, 20 with telephone visits at weeks 15, 17, and 19.
99335|NCT01977729|O2|Outcome|Switch to SRT Alone|"Sertraline: Medication will be administered daily using a fixed-flexible strategy beginning at 25mg, titrating to 200mg across 8 wks (i.e., wks 9-17). We expect patients' medication dose will be adjusted upward in 50 mg/day increments if clinician-rated CGI-S anxiety severity is 3 (mild) or greater."
99336|NCT01977729|O1|Outcome|CBT With SRT|CBT (Cognitive Behavioral Therapy)+SRT (Sertraline) will be scheduled at weeks 9-12, 14, 16, 18, 20 with telephone visits at weeks 15, 17, and 19.
99337|NCT01977729|O2|Outcome|Switch to SRT Alone|"Sertraline: Medication will be administered daily using a fixed-flexible strategy beginning at 25mg, titrating to 200mg across 8 wks (i.e., wks 9-17). We expect patients' medication dose will be adjusted upward in 50 mg/day increments if clinician-rated CGI-S anxiety severity is 3 (mild) or greater."
99338|NCT01977729|O1|Outcome|CBT With SRT|CBT (Cognitive Behavioral Therapy)+SRT (Sertraline) will be scheduled at weeks 9-12, 14, 16, 18, 20 with telephone visits at weeks 15, 17, and 19.
99339|NCT01977729|E2|Reported Event|Switch to SRT Alone|"Sertraline: Medication will be administered daily using a fixed-flexible strategy beginning at 25mg, titrating to 200mg across 8 wks (i.e., wks 9-17). We expect patients' medication dose will be adjusted upward in 50 mg/day increments if clinician-rated CGI-S anxiety severity is 3 (mild) or greater."
99340|NCT01977729|E1|Reported Event|CBT With SRT|CBT (Cognitive Behavioral Therapy)+SRT (Sertraline) will be scheduled at weeks 9-12, 14, 16, 18, 20 with telephone visits at weeks 15, 17, and 19.
99341|NCT01977690|B3|Baseline|Total|Total of all reporting groups
99342|NCT01977690|B2|Baseline|Clavicle Brace Wearing|"Patient has to wear clavicle brace for one month.~Clavicle Brace"
99347|NCT01977690|O1|Outcome|Standard Management|Patients received analgesics ad libitum
99352|NCT01977625|P1|Participant Flow|Lisdexamfetamine, Then Placebo|Participants first received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks followed by a 2-week washout, then they received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.
99353|NCT01977625|O2|Outcome|Placebo|14 participants completed all 3 scans.
99354|NCT01977625|O1|Outcome|Lisdexamfetamine|14 participants completed all 3 scans.
99355|NCT01977625|O2|Outcome|Placebo|"Placebo pill, capsules~Placebo: To assess the effects of a placebo pill on brain activation patterns during tasks of sustained attention and working memory in menopausal women."
99356|NCT01977625|O1|Outcome|Lisdexamfetamine|"Lisdexamfetamine or Vyvanse~Lisdexamfetamine: The overall objective of this study is to assess the effects of LDX on brain activation patterns during tasks of sustained attention and working memory in menopausal women."
99357|NCT01977625|E2|Reported Event|Placebo|Participants first received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks followed by a 2-week washout, then they received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks.
99358|NCT01977625|E1|Reported Event|Lisdexamfetamine|Participants first received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks followed by a 2-week washout, then they received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.
99359|NCT01977612|B3|Baseline|Total|Total of all reporting groups
99360|NCT01977612|B2|Baseline|4-0 Monofilament Sutures|Skin closure using 4-0 monofilament sutures
99361|NCT01977612|B1|Baseline|Stainless Steel Staples|Skin closure using stainless steel staples.
99362|NCT01977612|P2|Participant Flow|4-0 Monofilament Sutures|Skin closure using 4-0 monofilament sutures
99363|NCT01977612|P1|Participant Flow|Stainless Steel Staples|Skin closure using stainless steel staples.
99364|NCT01977612|O2|Outcome|4-0 Monofilament Sutures|Skin closure using 4-0 monofilament sutures
99365|NCT01977612|O1|Outcome|Stainless Steel Staples|Skin closure using stainless steel staples.
99366|NCT01977612|O2|Outcome|4-0 Monofilament Sutures|Skin closure using 4-0 monofilament sutures
99367|NCT01977612|O1|Outcome|Stainless Steel Staples|Skin closure using stainless steel staples.
99368|NCT01977612|O2|Outcome|4-0 Monofilament Sutures|Skin closure using 4-0 monofilament sutures
99369|NCT01977612|O1|Outcome|Stainless Steel Staples|Skin closure using stainless steel staples.
99370|NCT01977612|O2|Outcome|4-0 Monofilament Sutures|Skin closure using 4-0 monofilament sutures
99371|NCT01977612|O1|Outcome|Stainless Steel Staples|Skin closure using stainless steel staples.
99372|NCT01977612|O2|Outcome|4-0 Monofilament Sutures|Skin closure using 4-0 monofilament sutures
99373|NCT01977612|O1|Outcome|Stainless Steel Staples|Skin closure using stainless steel staples.
99374|NCT01977612|O2|Outcome|4-0 Monofilament Sutures|Skin closure using 4-0 monofilament sutures
99375|NCT01977612|O1|Outcome|Stainless Steel Staples|Skin closure using stainless steel staples.
99376|NCT01977612|O2|Outcome|4-0 Monofilament Sutures|Skin closure using 4-0 monofilament sutures
99377|NCT01977612|O1|Outcome|Stainless Steel Staples|Skin closure using stainless steel staples.
99378|NCT01977612|E2|Reported Event|4-0 Monofilament Sutures|Skin closure using 4-0 monofilament sutures
99379|NCT01977612|E1|Reported Event|Stainless Steel Staples|Skin closure using stainless steel staples.
99380|NCT01977573|B5|Baseline|Total|Total of all reporting groups
99381|NCT01977573|B4|Baseline|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
99382|NCT01977573|B3|Baseline|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99383|NCT01977573|B2|Baseline|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
99384|NCT01977573|B1|Baseline|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99385|NCT01977573|P4|Participant Flow|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
99386|NCT01977573|P3|Participant Flow|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99387|NCT01977573|P2|Participant Flow|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
99388|NCT01977573|P1|Participant Flow|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99506|NCT01977482|P2|Participant Flow|GSK1278863 4 mg|Participants received GSK1278863 4 milligrams (mg) once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99389|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99390|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99391|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
99392|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99393|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
99394|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99395|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99396|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99397|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
99398|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99399|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
99400|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99401|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
99402|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99403|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
99404|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99405|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99406|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99407|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
100850|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
99408|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99409|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
99410|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99411|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
99412|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99413|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
99414|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99415|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99416|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99417|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99418|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99419|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99420|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99421|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99422|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99423|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99424|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99425|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99507|NCT01977482|P1|Participant Flow|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99426|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99427|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
99428|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99429|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
99430|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99431|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
99432|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99433|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
99434|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99435|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
99436|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99437|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
99438|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99439|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
99440|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99441|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
99442|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99443|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
99444|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99695|NCT01976845|O3|Outcome|Saline|"Saline 2 ml~Saline: Saline 2 ml IV, in the pre-op area as a premedication"
99445|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
99446|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99447|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
99448|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99449|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
99450|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99451|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
99452|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99453|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
99454|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99455|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
99456|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99457|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
99458|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99459|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
99460|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99461|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
99462|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99463|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
99834|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
99464|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99465|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
99466|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99467|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
99468|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99469|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
99470|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99471|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
99472|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99473|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
99474|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99475|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
99476|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99477|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
99478|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99479|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
99480|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99481|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
99482|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99483|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
99484|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99485|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
99486|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99487|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
99488|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99489|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
99490|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99491|NCT01977573|E4|Reported Event|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
99492|NCT01977573|E3|Reported Event|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
99493|NCT01977573|E2|Reported Event|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
99494|NCT01977573|E1|Reported Event|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
99495|NCT01977482|B7|Baseline|Total|Total of all reporting groups
99496|NCT01977482|B6|Baseline|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99497|NCT01977482|B5|Baseline|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99498|NCT01977482|B4|Baseline|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99499|NCT01977482|B3|Baseline|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99500|NCT01977482|B2|Baseline|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99501|NCT01977482|B1|Baseline|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99502|NCT01977482|P6|Participant Flow|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99503|NCT01977482|P5|Participant Flow|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99504|NCT01977482|P4|Participant Flow|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99505|NCT01977482|P3|Participant Flow|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99508|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99509|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99510|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99511|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99512|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99513|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99514|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99515|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99516|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99517|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99518|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99519|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99520|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99521|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99522|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99523|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99524|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99525|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99526|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99527|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99528|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99529|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99530|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99531|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99532|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99533|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99534|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99535|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99537|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99538|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99539|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99540|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99541|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99542|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99543|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99544|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99545|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99546|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99547|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99548|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99549|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99550|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99551|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99552|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99553|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99554|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99555|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99556|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99557|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99558|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99559|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99560|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99561|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99562|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99563|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99564|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99565|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99566|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99567|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99568|NCT01977482|O5|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99569|NCT01977482|O4|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99570|NCT01977482|O3|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99571|NCT01977482|O2|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99572|NCT01977482|O1|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99573|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99574|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99575|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99576|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99577|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99578|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99579|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99580|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99581|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99582|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99583|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99584|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99585|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99586|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99587|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99588|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99589|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99590|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99591|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99592|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99593|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99594|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99595|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99596|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99597|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99598|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99599|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99600|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99601|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99602|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99603|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99604|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99605|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99606|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99607|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99608|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99609|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99610|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99611|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99612|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99613|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99614|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99615|NCT01977482|E6|Reported Event|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99616|NCT01977482|E5|Reported Event|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99617|NCT01977482|E4|Reported Event|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99618|NCT01977482|E3|Reported Event|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99619|NCT01977482|E2|Reported Event|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99620|NCT01977482|E1|Reported Event|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
99621|NCT01977456|B1|Baseline|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.~Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
99622|NCT01977456|P1|Participant Flow|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.~Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
99623|NCT01977456|O1|Outcome|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.~Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
99624|NCT01977456|O1|Outcome|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.~Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
99625|NCT01977456|O1|Outcome|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.~Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
99626|NCT01977456|O1|Outcome|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.~Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
99627|NCT01977456|E1|Reported Event|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.~Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
99628|NCT01977352|B3|Baseline|Total|Total of all reporting groups
99629|NCT01977352|B2|Baseline|Bupivacaine 0.25%|20 cc of bupivacaine 0.25%
99630|NCT01977352|B1|Baseline|Liposomal Bupivacaine|liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
99631|NCT01977352|P2|Participant Flow|Bupivacaine 0.25%|20 cc of bupivacaine 0.25%
99632|NCT01977352|P1|Participant Flow|Liposomal Bupivacaine|liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
99633|NCT01977352|O2|Outcome|Bupivacaine 0.25%|20 cc of bupivacaine 0.25%
99634|NCT01977352|O1|Outcome|Liposomal Bupivacaine|liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
99635|NCT01977352|O2|Outcome|Bupivacaine 0.25%|20 cc of bupivacaine 0.25%
99636|NCT01977352|O1|Outcome|Liposomal Bupivacaine|liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
99637|NCT01977352|O2|Outcome|Bupivacaine 0.25%|20 cc of bupivacaine 0.25%
99638|NCT01977352|O1|Outcome|Liposomal Bupivacaine|liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
99639|NCT01977352|O2|Outcome|Bupivacaine 0.25%|20 cc of bupivacaine 0.25%
99640|NCT01977352|O1|Outcome|Liposomal Bupivacaine|liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
99641|NCT01977352|O2|Outcome|Bupivacaine 0.25%|20 cc of bupivacaine 0.25%
99642|NCT01977352|O1|Outcome|Liposomal Bupivacaine|liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
99643|NCT01977352|O2|Outcome|Bupivacaine 0.25%|20 cc of bupivacaine 0.25%
99644|NCT01977352|O1|Outcome|Liposomal Bupivacaine|liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
99645|NCT01977352|O2|Outcome|Bupivacaine 0.25%|20 cc of bupivacaine 0.25%
99646|NCT01977352|O1|Outcome|Liposomal Bupivacaine|liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
99647|NCT01977352|E2|Reported Event|Bupivacaine 0.25%|20 cc of bupivacaine 0.25%
99648|NCT01977352|E1|Reported Event|Liposomal Bupivacaine|liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
99649|NCT01977222|B1|Baseline|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER: Subjects will be provided with noseclips and a threshold impedance device set to 40% of their measured maximal inspiratory pressure and will be trained on using the device. Specifically, subjects will be instructed to breathe through the inspiratory muscle training device while wearing noseclips at a rate of 12 to 16 breaths per minute for 30 minutes a day, 5 days a week for 12 consecutive weeks. Each subject will be provided a customized schedule for increasing resistance by 2 cm H2O every 2 weeks to a maximum resistance of 41 cm H2O.
99650|NCT01977222|P1|Participant Flow|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER: Subjects will be provided with noseclips and a threshold impedance device set to 40% of their measured maximal inspiratory pressure and will be trained on using the device. Specifically, subjects will be instructed to breathe through the inspiratory muscle training device while wearing noseclips at a rate of 12 to 16 breaths per minute for 30 minutes a day, 5 days a week for 12 consecutive weeks. Each subject will be provided a customized schedule for increasing resistance by 2 cm H2O every 2 weeks to a maximum resistance of 41 cm H2O.
99665|NCT01976988|O2|Outcome|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
99835|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
99651|NCT01977222|O1|Outcome|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER: Subjects will be provided with noseclips and a threshold impedance device set to 40% of their measured maximal inspiratory pressure and will be trained on using the device. Specifically, subjects will be instructed to breathe through the inspiratory muscle training device while wearing noseclips at a rate of 12 to 16 breaths per minute for 30 minutes a day, 5 days a week for 12 consecutive weeks. Each subject will be provided a customized schedule for increasing resistance by 2 cm H2O every 2 weeks to a maximum resistance of 41 cm H2O.
99652|NCT01977222|O1|Outcome|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER: Subjects will be provided with noseclips and a threshold impedance device set to 40% of their measured maximal inspiratory pressure and will be trained on using the device. Specifically, subjects will be instructed to breathe through the inspiratory muscle training device while wearing noseclips at a rate of 12 to 16 breaths per minute for 30 minutes a day, 5 days a week for 12 consecutive weeks. Each subject will be provided a customized schedule for increasing resistance by 2 cm H2O every 2 weeks to a maximum resistance of 41 cm H2O.
99653|NCT01977222|O1|Outcome|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER: Subjects will be provided with noseclips and a threshold impedance device set to 40% of their measured maximal inspiratory pressure and will be trained on using the device. Specifically, subjects will be instructed to breathe through the inspiratory muscle training device while wearing noseclips at a rate of 12 to 16 breaths per minute for 30 minutes a day, 5 days a week for 12 consecutive weeks. Each subject will be provided a customized schedule for increasing resistance by 2 cm H2O every 2 weeks to a maximum resistance of 41 cm H2O.
99654|NCT01977222|O1|Outcome|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER: Subjects will be provided with noseclips and a threshold impedance device set to 40% of their measured maximal inspiratory pressure and will be trained on using the device. Specifically, subjects will be instructed to breathe through the inspiratory muscle training device while wearing noseclips at a rate of 12 to 16 breaths per minute for 30 minutes a day, 5 days a week for 12 consecutive weeks. Each subject will be provided a customized schedule for increasing resistance by 2 cm H2O every 2 weeks to a maximum resistance of 41 cm H2O.
99655|NCT01977222|O1|Outcome|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER: Subjects will be provided with noseclips and a threshold impedance device set to 40% of their measured maximal inspiratory pressure and will be trained on using the device. Specifically, subjects will be instructed to breathe through the inspiratory muscle training device while wearing noseclips at a rate of 12 to 16 breaths per minute for 30 minutes a day, 5 days a week for 12 consecutive weeks. Each subject will be provided a customized schedule for increasing resistance by 2 cm H2O every 2 weeks to a maximum resistance of 41 cm H2O.
99656|NCT01977222|O1|Outcome|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER: Subjects will be provided with noseclips and a threshold impedance device set to 40% of their measured maximal inspiratory pressure and will be trained on using the device. Specifically, subjects will be instructed to breathe through the inspiratory muscle training device while wearing noseclips at a rate of 12 to 16 breaths per minute for 30 minutes a day, 5 days a week for 12 consecutive weeks. Each subject will be provided a customized schedule for increasing resistance by 2 cm H2O every 2 weeks to a maximum resistance of 41 cm H2O.
99657|NCT01977222|O1|Outcome|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER: Subjects will be provided with noseclips and a threshold impedance device set to 40% of their measured maximal inspiratory pressure and will be trained on using the device. Specifically, subjects will be instructed to breathe through the inspiratory muscle training device while wearing noseclips at a rate of 12 to 16 breaths per minute for 30 minutes a day, 5 days a week for 12 consecutive weeks. Each subject will be provided a customized schedule for increasing resistance by 2 cm H2O every 2 weeks to a maximum resistance of 41 cm H2O.
99658|NCT01977222|O1|Outcome|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER: Subjects will be provided with noseclips and a threshold impedance device set to 40% of their measured maximal inspiratory pressure and will be trained on using the device. Specifically, subjects will be instructed to breathe through the inspiratory muscle training device while wearing noseclips at a rate of 12 to 16 breaths per minute for 30 minutes a day, 5 days a week for 12 consecutive weeks. Each subject will be provided a customized schedule for increasing resistance by 2 cm H2O every 2 weeks to a maximum resistance of 41 cm H2O.
99659|NCT01977222|E1|Reported Event|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER: Subjects will be provided with noseclips and a threshold impedance device set to 40% of their measured maximal inspiratory pressure and will be trained on using the device. Specifically, subjects will be instructed to breathe through the inspiratory muscle training device while wearing noseclips at a rate of 12 to 16 breaths per minute for 30 minutes a day, 5 days a week for 12 consecutive weeks. Each subject will be provided a customized schedule for increasing resistance by 2 cm H2O every 2 weeks to a maximum resistance of 41 cm H2O.
99660|NCT01976988|B3|Baseline|Total|Total of all reporting groups
99661|NCT01976988|B2|Baseline|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
99662|NCT01976988|B1|Baseline|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
99663|NCT01976988|P2|Participant Flow|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
99664|NCT01976988|P1|Participant Flow|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
99666|NCT01976988|O1|Outcome|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
99667|NCT01976988|O2|Outcome|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
99668|NCT01976988|O1|Outcome|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
99669|NCT01976988|O2|Outcome|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
99670|NCT01976988|O1|Outcome|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
99671|NCT01976988|O2|Outcome|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
99672|NCT01976988|O1|Outcome|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
99673|NCT01976988|O2|Outcome|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
99674|NCT01976988|O1|Outcome|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
99675|NCT01976988|O2|Outcome|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
99676|NCT01976988|O1|Outcome|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
99677|NCT01976988|E2|Reported Event|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
99678|NCT01976988|E1|Reported Event|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
99679|NCT01976871|B1|Baseline|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
99680|NCT01976871|P1|Participant Flow|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
99681|NCT01976871|O1|Outcome|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
99682|NCT01976871|O1|Outcome|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
99683|NCT01976871|O1|Outcome|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
99684|NCT01976871|O1|Outcome|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
99685|NCT01976871|O1|Outcome|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
99686|NCT01976871|O1|Outcome|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
99687|NCT01976871|E1|Reported Event|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
99688|NCT01976845|B4|Baseline|Total|Total of all reporting groups
99689|NCT01976845|B3|Baseline|Saline|"Saline 2 ml~Saline: Saline 2 ml IV, in the pre-op area as a premedication"
99690|NCT01976845|B2|Baseline|Midazolam|"Midazolam 2 mg IV (2 ml)~Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
99691|NCT01976845|B1|Baseline|Propofol|"Propofol 20 mg IV (2 ml)~Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
99692|NCT01976845|P3|Participant Flow|Saline|"Saline 2 ml~Saline: Saline 2 ml IV, in the pre-op area as a premedication"
99693|NCT01976845|P2|Participant Flow|Midazolam|"Midazolam 2 mg IV (2 ml)~Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
99694|NCT01976845|P1|Participant Flow|Propofol|"Propofol 20 mg IV (2 ml)~Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
99696|NCT01976845|O2|Outcome|Midazolam|"Midazolam 2 mg IV (2 ml)~Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
99697|NCT01976845|O1|Outcome|Propofol|"Propofol 20 mg IV (2 ml)~Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
99698|NCT01976845|O3|Outcome|Saline|"Saline 2 ml~Saline: Saline 2 ml IV, in the pre-op area as a premedication"
99699|NCT01976845|O2|Outcome|Midazolam|"Midazolam 2 mg IV (2 ml)~Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
99700|NCT01976845|O1|Outcome|Propofol|"Propofol 20 mg IV (2 ml)~Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
99701|NCT01976845|O3|Outcome|Saline|"Saline 2 ml~Saline: Saline 2 ml IV, in the pre-op area as a premedication"
99702|NCT01976845|O2|Outcome|Midazolam|"Midazolam 2 mg IV (2 ml)~Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
99703|NCT01976845|O1|Outcome|Propofol|"Propofol 20 mg IV (2 ml)~Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
99704|NCT01976845|E3|Reported Event|Saline|"Saline 2 ml~Saline: Saline 2 ml IV, in the pre-op area as a premedication"
99705|NCT01976845|E2|Reported Event|Midazolam|"Midazolam 2 mg IV (2 ml)~Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
99706|NCT01976845|E1|Reported Event|Propofol|"Propofol 20 mg IV (2 ml)~Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
99707|NCT01976819|B1|Baseline|TW Speaking Valve/HME|"Use of the TW speaking valve/HME~TW speaking valve/HME: The TW speaking valve with HME will be used during the day, whereas during sleep patients will use an HME without an automatic speaking valve"
99708|NCT01976819|P1|Participant Flow|TW Speaking Valve/HME|"At baseline, participants were asked to complete a baseline questionnaire. After that, patients were asked to use both the current (old) TW15 or the TW22 for a week. After each week, patients completed a device specific questionnaire. At the end of the two week period, patients also completed a structured and comparative questionnaire.~Patients were then asked to use the new updated Speaking Valve for a week and then to complete relevant sections of the same questionnaire that was also used for the previous (old) device. Patients could decide again whether they wanted to participate in the long term part of the study, which will follow the same structure with the same questionnaires as in Stage 0."
99709|NCT01976819|O2|Outcome|Use of Old Speaking Valve|Data from TW15 and 22 combined.
99710|NCT01976819|O1|Outcome|Use of Updated Speaking Valve|"Use of the TW speaking valve/HME~TW speaking valve/HME: The TW speaking valve with HME will be used during the day, whereas during sleep patients will use an HME without an automatic speaking valve. Data from TW15 and 22 are combined."
99711|NCT01976819|O2|Outcome|Use of Old Speaking Valve|Usage of the old speaking valve device. TW15 and TW22 combined.
99712|NCT01976819|O1|Outcome|Use of Updated Speaking Valve|"Use of the TW speaking valve/HME~TW speaking valve/HME: The TW speaking valve with HME will be used during the day, whereas during sleep patients will use an HME without an automatic speaking valve. Data from TW15 and 22 combined."
99713|NCT01976819|O2|Outcome|Use of the Old HME Speaking Valve|Data from the use of the old HME speaking valve, data from TW15 and TW22 combined.
99714|NCT01976819|O1|Outcome|Updated Speaking Valve/HME|"Use of the updated speaking valve/HME~TW speaking valve/HME: The TW speaking valve with HME will be used during the day, whereas during sleep patients will use an HME without an automatic speaking valve. Data from TW15 and 22 combined."
99715|NCT01976819|E1|Reported Event|TW Speaking Valve/HME|"Use of the TW speaking valve/HME~TW speaking valve/HME: The TW speaking valve with HME will be used during the day, whereas during sleep patients will use an HME without an automatic speaking valve"
99716|NCT01976806|B3|Baseline|Total|Total of all reporting groups
99717|NCT01976806|B2|Baseline|Aspirin & Placebo|"Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months~Aspirin~Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules"
99718|NCT01976806|B1|Baseline|Aspirin & Docosahexaenoic Acid|"Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months~Aspirin~Docosahexaenoic acid"
99719|NCT01976806|P2|Participant Flow|Aspirin & Placebo|"Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months~Aspirin~Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules"
99720|NCT01976806|P1|Participant Flow|Aspirin & Docosahexaenoic Acid|"Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months~Aspirin~Docosahexaenoic acid"
99721|NCT01976806|O2|Outcome|Aspirin & Placebo|"Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months~Aspirin~Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules"
99722|NCT01976806|O1|Outcome|Aspirin & Docosahexaenoic Acid|"Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months~Aspirin~Docosahexaenoic acid"
99723|NCT01976806|O2|Outcome|Aspirin & Placebo|"Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months~Aspirin~Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules"
99724|NCT01976806|O1|Outcome|Aspirin & Docosahexaenoic Acid|"Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months~Aspirin~Docosahexaenoic acid"
99725|NCT01976806|O2|Outcome|Aspirin & Placebo|"Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months~Aspirin~Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules"
99726|NCT01976806|O1|Outcome|Aspirin & Docosahexaenoic Acid|"Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months~Aspirin~Docosahexaenoic acid"
99727|NCT01976806|O2|Outcome|Aspirin & Placebo|"Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months~Aspirin~Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules"
99836|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
99728|NCT01976806|O1|Outcome|Aspirin & Docosahexaenoic Acid|"Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months~Aspirin~Docosahexaenoic acid"
99729|NCT01976806|O2|Outcome|Aspirin & Placebo|"Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months~Aspirin~Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules"
99730|NCT01976806|O1|Outcome|Aspirin & Docosahexaenoic Acid|"Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months~Aspirin~Docosahexaenoic acid"
99731|NCT01976806|O2|Outcome|Aspirin & Placebo|"Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months~Aspirin~Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules"
99732|NCT01976806|O1|Outcome|Aspirin & Docosahexaenoic Acid|"Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months~Aspirin~Docosahexaenoic acid"
99733|NCT01976806|O2|Outcome|Aspirin & Placebo|"Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months~Aspirin~Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules"
99734|NCT01976806|O1|Outcome|Aspirin & Docosahexaenoic Acid|"Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months~Aspirin~Docosahexaenoic acid"
99735|NCT01976806|O2|Outcome|Aspirin & Placebo|"Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months~Aspirin~Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules"
99736|NCT01976806|O1|Outcome|Aspirin & Docosahexaenoic Acid|"Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months~Aspirin~Docosahexaenoic acid"
99737|NCT01976806|O2|Outcome|Aspirin & Placebo|"Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months~Aspirin~Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules"
99738|NCT01976806|O1|Outcome|Aspirin & Docosahexaenoic Acid|"Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months~Aspirin~Docosahexaenoic acid"
99739|NCT01976806|O2|Outcome|Aspirin & Placebo|"Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months~Aspirin~Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules"
99740|NCT01976806|O1|Outcome|Aspirin & Docosahexaenoic Acid|"Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months~Aspirin~Docosahexaenoic acid"
99741|NCT01976806|O2|Outcome|Aspirin & Placebo|"Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months~Aspirin~Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules"
99742|NCT01976806|O1|Outcome|Aspirin & Docosahexaenoic Acid|"Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months~Aspirin~Docosahexaenoic acid"
99743|NCT01976806|O2|Outcome|Aspirin & Placebo|"Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months~Aspirin~Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules"
99744|NCT01976806|O1|Outcome|Aspirin & Docosahexaenoic Acid|"Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months~Aspirin~Docosahexaenoic acid"
99745|NCT01976806|E2|Reported Event|Placebo (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)|
99746|NCT01976806|E1|Reported Event|DHA 2 gm (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)|
99747|NCT01976663|B1|Baseline|JUVEDERM VOLIFT® XC|Nasolabial folds treated with JUVEDERM VOLIFT® XC on one side and Control on the other side.
99748|NCT01976663|P1|Participant Flow|JUVEDERM VOLIFT® XC|Nasolabial folds treated with JUVEDERM VOLIFT® XC on one side and Control on the other side.
99749|NCT01976663|O2|Outcome|Control|Nasolabial folds treated with Control.
99750|NCT01976663|O1|Outcome|JUVEDERM VOLIFT® XC|Nasolabial folds treated with JUVEDERM VOLIFT® XC.
99751|NCT01976663|O2|Outcome|Control|Nasolabial folds treated with Control.
99752|NCT01976663|O1|Outcome|JUVEDERM VOLIFT® XC|Nasolabial folds treated with JUVEDERM VOLIFT® XC.
99753|NCT01976663|O2|Outcome|Control|Nasolabial folds treated with Control.
99754|NCT01976663|O1|Outcome|JUVEDERM VOLIFT® XC|Nasolabial folds treated with JUVEDERM VOLIFT® XC.
99755|NCT01976663|O2|Outcome|Control|Nasolabial folds treated with Control.
99756|NCT01976663|O1|Outcome|JUVEDERM VOLIFT® XC|Nasolabial folds treated with JUVEDERM VOLIFT® XC.
99757|NCT01976663|E4|Reported Event|JUVEDERM VOLIFT® XC Asymmetry Correction/Repeat Treatment|Nasolabial folds treated with JUVEDERM VOLIFT® XC during the Asymmetry Correction/Repeat Treatment period.
99758|NCT01976663|E3|Reported Event|Not at NLF During Initial/Touch Up Treatment Period|Nasolabial folds treated with JUVEDERM VOLIFT® XC on one side and Control on the other side.
99759|NCT01976663|E2|Reported Event|Control During Initial/Touch Up Treatment Period|Nasolabial folds treated with Control during the Initial/Touch Up period.
99760|NCT01976663|E1|Reported Event|JUVEDERM VOLIFT® XC During Initial/Touch Up|Nasolabial folds treated with JUVEDERM VOLIFT® XC during the Initial/Touch Up period.
99761|NCT01976650|B1|Baseline|OZURDEX®|Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
99762|NCT01976650|P1|Participant Flow|OZURDEX®|Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
99763|NCT01976650|O1|Outcome|OZURDEX®|Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
99764|NCT01976650|O1|Outcome|OZURDEX®|Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
99765|NCT01976650|E1|Reported Event|OZURDEX®|Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
99766|NCT01976624|B1|Baseline|Ganfort®|Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
99767|NCT01976624|P1|Participant Flow|Ganfort®|Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
99768|NCT01976624|O1|Outcome|Ganfort®|Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
99769|NCT01976624|O1|Outcome|Ganfort®|Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
99770|NCT01976624|E1|Reported Event|Ganfort®|Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
99771|NCT01976572|B1|Baseline|All Subjects|
99772|NCT01976572|P3|Participant Flow|Treatment C|On Day 1, a single dose of candesartan (16 mg) was administered. On Day 7, candesartan was administered at 3 hours after (T+3) the first daily dose of colestilan. On Day 13, the first daily dose of colestilan and candesartan was administered together (T0), and on Day 19 candesartan was administered at 1 hour before (T-1) the first daily dose of colestilan.
99773|NCT01976572|P2|Participant Flow|Treatment B|On Day 1, a single dose of candesartan (16 mg) was administered. On Day 7, candesartan was administered at 1 hour before (T-1) the first daily dose of colestilan. On Day 13, candesartan was administered at 3 hours after (T+3) the first daily dose of colestilan, and on Day 19, the first daily dose of colestilan and candesartan were administered together (T0).
99774|NCT01976572|P1|Participant Flow|Treatment A|On Day 1, a single dose of candesartan (16 mg) was administered. On Day 7, the first daily dose of colestilan (5 g) and candesartan were administered together (T0). On Day 13, candesartan was administered at 1 hour before (T-1) the first daily dose of colestilan, and on Day 19 at 3 hours after (T+3) the first daily dose of colestilan.
99775|NCT01976572|O4|Outcome|T+3hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 3 hour after
99776|NCT01976572|O3|Outcome|T0hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at the same time
99777|NCT01976572|O2|Outcome|T-1hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 1 hour before
99778|NCT01976572|O1|Outcome|Candesartan Alone|Single dose of candesartan (16 mg) only
99779|NCT01976572|O4|Outcome|T+3hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 3 hour after
99780|NCT01976572|O3|Outcome|T0hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at the same time
99781|NCT01976572|O2|Outcome|T-1hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 1 hour before
99782|NCT01976572|O1|Outcome|Candesartan Alone|Single dose of candesartan (16 mg) only
99783|NCT01976572|O4|Outcome|T+3hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 3 hour after
99784|NCT01976572|O3|Outcome|T0hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at the same time
99785|NCT01976572|O2|Outcome|T-1hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 1 hour before
99786|NCT01976572|O1|Outcome|Candesartan Alone|Single dose of candesartan (16 mg) only
99787|NCT01976572|O4|Outcome|T+3hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 3 hour after
99788|NCT01976572|O3|Outcome|T0hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at the same time
99789|NCT01976572|O2|Outcome|T-1hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 1 hour before
99790|NCT01976572|O1|Outcome|Candesartan Alone|Single dose of candesartan (16 mg) only
99791|NCT01976572|E3|Reported Event|Candesartan Plus Colestilan (Day 7 to 24)|
99792|NCT01976572|E2|Reported Event|Colestilan Alone (Day 3 to 6)|
99793|NCT01976572|E1|Reported Event|Candesartan Alone (Day 1 to 2)|
99794|NCT01976507|B1|Baseline|Dabigatran Etexilate Mesylate|"Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation.~dabigatran etexilate mesylate: Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation."
99795|NCT01976507|P1|Participant Flow|Dabigatran Etexilate Mesylate|"Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation.~dabigatran etexilate mesylate: Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation."
99837|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
99838|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
99796|NCT01976507|O1|Outcome|Dabigatran Etexilate Mesylate|"Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation.~dabigatran etexilate mesylate: Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation."
99797|NCT01976507|O1|Outcome|Dabigatran Etexilate Mesylate|"Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation.~dabigatran etexilate mesylate: Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation."
99798|NCT01976507|O1|Outcome|Dabigatran Etexilate Mesylate|"Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation.~dabigatran etexilate mesylate: Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation."
99799|NCT01976507|O1|Outcome|Dabigatran Etexilate Mesylate|"Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation.~dabigatran etexilate mesylate: Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation."
99800|NCT01976507|E1|Reported Event|Dabigatran Etexilate Mesylate|"Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation.~dabigatran etexilate mesylate: Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation."
99801|NCT01976442|B3|Baseline|Total|Total of all reporting groups
99802|NCT01976442|B2|Baseline|Unwashed|Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
99803|NCT01976442|B1|Baseline|Washed|Washed red blood cell transfusions given to all patients with acute myeloid leukemia.
99804|NCT01976442|P2|Participant Flow|Unwashed|Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
99805|NCT01976442|P1|Participant Flow|Washed|Washed red blood cell transfusions given to all patients with acute myeloid leukemia.
99806|NCT01976442|O2|Outcome|Unwashed|Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
99807|NCT01976442|O1|Outcome|Washed|Washed red blood cell transfusions given to all patients with acute myeloid leukemia.
99808|NCT01976442|O2|Outcome|Unwashed|Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
99809|NCT01976442|O1|Outcome|Washed|Washed red blood cell transfusions given to all patients with acute myeloid leukemia.
99810|NCT01976442|O2|Outcome|Unwashed|Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
99811|NCT01976442|O1|Outcome|Washed|Washed red blood cell transfusions given to all patients with acute myeloid leukemia.
99812|NCT01976442|O2|Outcome|Unwashed|Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
99813|NCT01976442|O1|Outcome|Washed|Washed red blood cell transfusions given to all patients with acute myeloid leukemia.
99814|NCT01976442|E2|Reported Event|Unwashed|Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
99815|NCT01976442|E1|Reported Event|Washed|Washed red blood cell transfusions given to all patients with acute myeloid leukemia.
99816|NCT01976338|B3|Baseline|Total|Total of all reporting groups
99817|NCT01976338|B2|Baseline|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
99818|NCT01976338|B1|Baseline|Ranibizumab 0.5 mg|PRN Intravitreal injection
99819|NCT01976338|P2|Participant Flow|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
99820|NCT01976338|P1|Participant Flow|Ranibizumab 0.5 mg|PRN Intravitreal injection
99821|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
99822|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
99823|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
99824|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
99825|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
99826|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
99827|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
99828|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
99829|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
99830|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
99831|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
99832|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
99833|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
99841|NCT01976338|E3|Reported Event|Sham Without Ranibizumab 0.5 mg|sham + ranibizumab 0.5 mg PRN as of Month 6 (hereafter referred to as sham group up to Month 6 and sham with ranibizumab or sham without ranibizumab after Month 6)
99842|NCT01976338|E2|Reported Event|Sham With Ranibizumab 0.5 mg|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
99843|NCT01976338|E1|Reported Event|Ranibizumab 0.5 mg|PRN Intravitreal injection
99844|NCT01976312|B3|Baseline|Total|Total of all reporting groups
99845|NCT01976312|B2|Baseline|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
99846|NCT01976312|B1|Baseline|Ranibizumab 0.5 mg|PRN intravitreal injection
99847|NCT01976312|P2|Participant Flow|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
99848|NCT01976312|P1|Participant Flow|Ranibizumab 0.5 mg|PRN intravitreal injection
99849|NCT01976312|O2|Outcome|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
99850|NCT01976312|O1|Outcome|Ranibizumab 0.5 mg|PRN intravitreal injection
99851|NCT01976312|O2|Outcome|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
99852|NCT01976312|O1|Outcome|Ranibizumab 0.5 mg|PRN intravitreal injection
99853|NCT01976312|O2|Outcome|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
99854|NCT01976312|O1|Outcome|Ranibizumab 0.5 mg|PRN intravitreal injection
99855|NCT01976312|O2|Outcome|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
99856|NCT01976312|O1|Outcome|Ranibizumab 0.5 mg|PRN intravitreal injection
99857|NCT01976312|O2|Outcome|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
99858|NCT01976312|O1|Outcome|Ranibizumab 0.5 mg|PRN intravitreal injection
99859|NCT01976312|O2|Outcome|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
99860|NCT01976312|O1|Outcome|Ranibizumab 0.5 mg|PRN intravitreal injection
99861|NCT01976312|O2|Outcome|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
99862|NCT01976312|O1|Outcome|Ranibizumab 0.5 mg|PRN intravitreal injection
99863|NCT01976312|E3|Reported Event|Sham Without Ranibizumab 0.5 mg|Sham without Ranibizumab 0.5mg(hereafter referred to as sham group up to Month 3 and sham without ranibizumab after Month 3
99864|NCT01976312|E2|Reported Event|Sham With Ranibizumab 0.5 mg|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
99865|NCT01976312|E1|Reported Event|Ranibizumab 0.5 mg|PRN intravitreal injection
99866|NCT01976299|B3|Baseline|Total|Total of all reporting groups
99867|NCT01976299|B2|Baseline|Standard of Care|
99868|NCT01976299|B1|Baseline|Active Treatment|"Standard of Care with the AVERT system~AVERT"
99869|NCT01976299|P2|Participant Flow|Standard of Care|
99870|NCT01976299|P1|Participant Flow|Active Treatment|"Standard of Care with the AVERT system~AVERT"
99871|NCT01976299|O2|Outcome|Standard of Care|
99872|NCT01976299|O1|Outcome|Active Treatment|"Standard of Care with the AVERT system~AVERT"
99873|NCT01976299|O2|Outcome|Standard of Care|
99874|NCT01976299|O1|Outcome|Active Treatment|"Standard of Care with the AVERT system~AVERT"
99875|NCT01976299|O2|Outcome|Standard of Care|
99876|NCT01976299|O1|Outcome|Active Treatment|"Standard of Care with the AVERT system~AVERT"
99877|NCT01976299|O2|Outcome|Standard of Care|
99878|NCT01976299|O1|Outcome|Active Treatment|"Standard of Care with the AVERT system~AVERT"
99879|NCT01976299|O2|Outcome|Standard of Care|
99880|NCT01976299|O1|Outcome|Active Treatment|"Standard of Care with the AVERT system~AVERT"
99881|NCT01976299|E2|Reported Event|Standard of Care|
99882|NCT01976299|E1|Reported Event|Active Treatment|"Standard of Care with the AVERT system~AVERT"
99883|NCT01976273|B3|Baseline|Total|Total of all reporting groups
99884|NCT01976273|B2|Baseline|Glycolic Acid Peels Comparator Left, Q-Switch Laser Right|"The unit of randomization was the subject who was randomized 1:1 to receive glycolic acid peel on one side of the face, while the contralateral side of the face received the 1064nm Q-switch laser.~Subjects in this arm were randomized to receive the interventions: 1064nm Q-switch laser on the right side of their face, and the glycolic acids peels on the left side of their face."
99885|NCT01976273|B1|Baseline|Q-switch Laser Left, Glycolic Acid Peels Comparator Right|"The unit of randomization was the subject who was randomized 1:1 to receive glycolic acid peel on one side of the face, while the contralateral side of the face received the 1064nm Q-switch laser.~Subjects in this arm were randomized to receive the interventions: 1064nm Q-switch laser on the left side of their face, and the glycolic acids peels on the right side of their face."
99886|NCT01976273|P2|Participant Flow|Glycolic Acid Peels Comparator Left, Q-Switch Laser Right|"The unit of randomization was the subject who was randomized 1:1 to receive glycolic acid peel on one side of the face, while the contralateral side of the face received the 1064nm Q-switch laser.~Subjects in this arm were randomized to receive the interventions: 1064nm Q-switch laser on the right side of their face, and the glycolic acids peels on the left side of their face."
99887|NCT01976273|P1|Participant Flow|Q-switch Laser Left, Glycolic Acid Peels Comparator Right|"The unit of randomization was the subject who was randomized 1:1 to receive glycolic acid peel on one side of the face, while the contralateral side of the face received the 1064nm Q-switch laser.~Subjects in this arm were randomized to receive the interventions: 1064nm Q-switch laser on the left side of their face, and the glycolic acids peels on the right side of their face."
99888|NCT01976273|O2|Outcome|Glycolic Acid Peels|"A Glycolic Acid Chemical Peel is a mild skin treatment used to correct uneven texture and color by removing dead cells from the skin’s outermost layer.~Glycolic Acid Peels"
99889|NCT01976273|O1|Outcome|1064nm Q-switch Laser|"The 1064 Q-Switch Laser is a medical device that uses a focused laser to remove dark pigment (color) from the skin.~1064nm Q-switch Laser"
99890|NCT01976273|E2|Reported Event|Glycolic Acid Peels|"A Glycolic Acid Chemical Peel is a mild skin treatment used to correct uneven texture and color by removing dead cells from the skin’s outermost layer.~Glycolic Acid Peels"
99891|NCT01976273|E1|Reported Event|1064nm Q-switch Laser|"The 1064 Q-Switch Laser is a medical device that uses a focused laser to remove dark pigment (color) from the skin.~1064nm Q-switch Laser"
99893|NCT01976104|B4|Baseline|40 mg Avatrombopag (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
99894|NCT01976104|B3|Baseline|40 mg Placebo (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.
99895|NCT01976104|B2|Baseline|60 mg Avatrombopag (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
99896|NCT01976104|B1|Baseline|60 mg Placebo (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/liters (L) took three 20 milligrams (mg) matching placebo tablets orally, once daily with a meal on Days 1 through 5.
99897|NCT01976104|P4|Participant Flow|40 mg Avatrombopag (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
99898|NCT01976104|P3|Participant Flow|40 mg Placebo (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.
99899|NCT01976104|P2|Participant Flow|60 mg Avatrombopag (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
99900|NCT01976104|P1|Participant Flow|60 mg Placebo (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/liters (L) took three 20 millilgrams (mg) matching placebo tablets orally, once daily with a meal on Days 1 through 5.
99901|NCT01976104|O4|Outcome|40 mg Avatrombopag (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
99902|NCT01976104|O3|Outcome|40 mg Placebo (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.
99903|NCT01976104|O2|Outcome|60 mg Avatrombopag (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
99904|NCT01976104|O1|Outcome|60 mg Placebo (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.
99905|NCT01976104|O4|Outcome|40 mg Avatrombopag (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
99906|NCT01976104|O3|Outcome|40 mg Placebo (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.
99907|NCT01976104|O2|Outcome|60 mg Avatrombopag (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
99908|NCT01976104|O1|Outcome|60 mg Placebo (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.
99909|NCT01976104|O4|Outcome|40 mg Avatrombopag (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
99910|NCT01976104|O3|Outcome|40 mg Placebo (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.
99911|NCT01976104|O2|Outcome|60 mg Avatrombopag (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
99912|NCT01976104|O1|Outcome|60 mg Placebo (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.
99913|NCT01976104|O4|Outcome|40 mg Avatrombopag (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
99914|NCT01976104|O3|Outcome|40 mg Placebo (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.
99915|NCT01976104|O2|Outcome|60 mg Avatrombopag (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
99916|NCT01976104|O1|Outcome|60 mg Placebo (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.
99917|NCT01976104|O4|Outcome|40 mg Avatrombopag (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
99918|NCT01976104|O3|Outcome|40 mg Placebo (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.
100425|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
99919|NCT01976104|O2|Outcome|60 mg Avatrombopag (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
99920|NCT01976104|O1|Outcome|60 mg Placebo (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/liters (L) took three 20 milligram (mg) matching placebo tablets orally, once daily with a meal on Days 1 through 5.
99921|NCT01976104|E4|Reported Event|40 mg Avatrombopag (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
99922|NCT01976104|E3|Reported Event|40 mg Placebo (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.
99923|NCT01976104|E2|Reported Event|60 mg Avatrombopag (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
99924|NCT01976104|E1|Reported Event|60 mg Placebo (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/liters (L) took three 20 milligrams (mg) matching placebo tablets orally, once daily with a meal on Days 1 through 5.
99925|NCT01975974|B1|Baseline|Ultrasound|"Ultrasound guided peripheral vascular access~Ultrasound: Using ultrasound as a guide for peripheral venous cannulation in obese patients"
99926|NCT01975974|P1|Participant Flow|Ultrasound|"Ultrasound guided peripheral vascular access~Ultrasound: Using ultrasound as a guide for peripheral venous cannulation in obese patients"
99927|NCT01975974|O1|Outcome|Ultrasound|"Ultrasound guided peripheral vascular access~Ultrasound: Using ultrasound as a guide for peripheral venous cannulation in obese patients"
99928|NCT01975974|E1|Reported Event|Ultrasound|"Ultrasound guided peripheral vascular access~Ultrasound: Using ultrasound as a guide for peripheral venous cannulation in obese patients"
99929|NCT01975948|B5|Baseline|Total|Total of all reporting groups
99930|NCT01975948|B4|Baseline|Treatment as Usual: Patient Sample|"Patients of physician who were randomized in the control group (TAU).~Inclusion criteria included >18 years of age, with a diagnosis of depression, PHQ-9 score of > 10, able to read and speak in English at grade 6 level, and intact cognitive functioning (physician judgment). Exclusion criteria included active treatment with antidepressants within 5 weeks and psychotherapy within 3 months of enrollment, and clinically judged urgent or emergent medical/psychiatric condition by their physician."
99931|NCT01975948|B3|Baseline|Practice Support Program: Patient Sample|"Patients of physicians trained in the Adult Mental Health Practice Support Program.~Inclusion criteria included >18 years of age, with a diagnosis of depression, PHQ-9 score of > 10, able to read and speak in English at grade 6 level, and intact cognitive functioning (physician judgment). Exclusion criteria included active treatment with antidepressants within 5 weeks and psychotherapy within 3 months of enrollment, and clinically judged urgent or emergent medical/psychiatric condition by their physician."
99932|NCT01975948|B2|Baseline|Treatment as Usual: Physician Sample|"Treatment as Usual for Depression~Depression Treatment as Usual: Physicians manage patients with depression as usual"
99933|NCT01975948|B1|Baseline|Practice Support Program: Physician Sample|"Physician training in Adult Mental Health Practice Support Program~Mental Health Practice Support Program: (1) training and (2) practice support.~•Three half day workshop sessions over a 24 week period.~•Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes"
99934|NCT01975948|P4|Participant Flow|Treatment as Usual: Patient Sample|Patients were assigned to the same arm as their physician, who were randomized to treating their patients as usual. Patients were enrolled between June 2014-May 2015 with the last follow-up visit in November 2015
99935|NCT01975948|P3|Participant Flow|Mental Health Practice Support Program;Patient Sample|Patients were assigned to the same arm as their physician who were randomized to the Practice Support Program training. Patients were enrolled between June 2014-May 2015 with the last follow-up visit in November 2015
99936|NCT01975948|P2|Participant Flow|Depression Treatment as Usual;Physician Sample|"Treatment as Usual for Depression~Depression Treatment as Usual: Physicians manage patients with depression as usual"
99937|NCT01975948|P1|Participant Flow|Mental Health Practice Support Program;Physician Sample|"Physician training in Adult Mental Health Practice Support Program~Mental Health Practice Support Program: (1) training and (2) practice support.~•Three half day workshop sessions over a 24 week period.~•Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes"
99938|NCT01975948|O2|Outcome|Treatment as Usual: Patients|Those receiving treatment as usual for depression.
99939|NCT01975948|O1|Outcome|Mental Health PSP: Patients|Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.
99940|NCT01975948|O2|Outcome|Treatment as Usual: Patients|Those receiving treatment as usual for depression.
99941|NCT01975948|O1|Outcome|Mental Health PSP: Patients|Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.
99942|NCT01975948|O2|Outcome|Treatment as Usual: Patients|Those receiving treatment as usual for depression.
99943|NCT01975948|O1|Outcome|Mental Health PSP: Patients|Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.
99944|NCT01975948|O2|Outcome|Treatment as Usual: Patients|Those receiving treatment as usual for depression.
99945|NCT01975948|O1|Outcome|Mental Health PSP: Patients|Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.
99946|NCT01975948|O2|Outcome|Treatment as Usual: Physicians|Depression Treatment as Usual: Physicians manage patients with depression as usual
100008|NCT01975675|P4|Participant Flow|LDV/SOF+RBV (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
99947|NCT01975948|O1|Outcome|Mental Health PSP: Physicians|"Physician training in Adult Mental Health Practice Support Program~Mental Health Practice Support Program: (1) training and (2) practice support.~•Three half day workshop sessions over a 24 week period.~•Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes"
99948|NCT01975948|O2|Outcome|Treatment as Usual: Physicians|Depression Treatment as Usual: Physicians manage patients with depression as usual
99949|NCT01975948|O1|Outcome|Mental Health PSP: Physicians|"Physician training in Adult Mental Health Practice Support Program~Mental Health Practice Support Program: (1) training and (2) practice support.~•Three half day workshop sessions over a 24 week period.~•Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes"
99950|NCT01975948|O2|Outcome|Treatment as Usual: Physician Sample|"Treatment as Usual for Depression~Depression Treatment as Usual: Physicians manage patients with depression as usual"
99951|NCT01975948|O1|Outcome|Practice Support Program: Physician Sample|"Physician training in Adult Mental Health Practice Support Program~Mental Health Practice Support Program: (1) training and (2) practice support.~•Three half day workshop sessions over a 24 week period.~•Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes"
99952|NCT01975948|O2|Outcome|Treatment as Usual: Patients|Those receiving treatment as usual for depression.
99953|NCT01975948|O1|Outcome|Mental Health PSP: Patients|Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.
99954|NCT01975948|O2|Outcome|Treatment as Usual: Physicians|Depression Treatment as Usual: Physicians manage patients with depression as usual
99955|NCT01975948|O1|Outcome|Mental Health PSP: Physicians|"Physician training in Adult Mental Health Practice Support Program~Mental Health Practice Support Program: (1) training and (2) practice support.~•Three half day workshop sessions over a 24 week period.~•Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes"
99956|NCT01975948|O2|Outcome|Treatment as Usual: Patients|Those receiving treatment as usual for depression.
99957|NCT01975948|O1|Outcome|Mental Health PSP: Patients|Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.
99958|NCT01975948|E2|Reported Event|Treatment as Usual: Patients|Those receiving treatment as usual for depression.
99959|NCT01975948|E1|Reported Event|Mental Health PSP: Patients|Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.
99960|NCT01975935|B3|Baseline|Total|Total of all reporting groups
99961|NCT01975935|B2|Baseline|Amlexanox|"Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks~Amlexanox"
99962|NCT01975935|B1|Baseline|Placebo|"Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks~Placebo"
99963|NCT01975935|P2|Participant Flow|Amlexanox|"Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks~Amlexanox"
99964|NCT01975935|P1|Participant Flow|Placebo|"Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks~Placebo"
99965|NCT01975935|O2|Outcome|Amlexanox|"Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks~Amlexanox"
99966|NCT01975935|O1|Outcome|Placebo|"Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks~Placebo"
99967|NCT01975935|O2|Outcome|Amlexanox|"Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks~Amlexanox"
99968|NCT01975935|O1|Outcome|Placebo|"Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks~Placebo"
99969|NCT01975935|O2|Outcome|Amlexanox|"Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks~Amlexanox"
99970|NCT01975935|O1|Outcome|Placebo|"Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks~Placebo"
99971|NCT01975935|E2|Reported Event|Amlexanox|"Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks~Amlexanox"
99972|NCT01975935|E1|Reported Event|Placebo|"Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks~Placebo"
99973|NCT01975922|B3|Baseline|Total|Total of all reporting groups
99974|NCT01975922|B2|Baseline|Community Services|Children receive speech-language services in the community. Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline.
99975|NCT01975922|B1|Baseline|Enhanced Milieu Teaching|"Parents receive 28 intervention sessions in which they learn to use language support strategies with their children.~Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline.~Enhanced Milieu Teaching: Enhanced Milieu Teaching (EMT) is a conversation-based model of early language intervention that uses child interest and initiations as opportunities to model and prompt language use in everyday contexts."
99976|NCT01975922|P2|Participant Flow|Community Services|Children receive speech-language services in the community. Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline.
99977|NCT01975922|P1|Participant Flow|Enhanced Milieu Teaching|"Parents receive 28 intervention sessions in which they learn to use language support strategies with their children.~Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline.~Enhanced Milieu Teaching: Enhanced Milieu Teaching (EMT) is a conversation-based model of early language intervention that uses child interest and initiations as opportunities to model and prompt language use in everyday contexts."
99978|NCT01975922|O2|Outcome|Community Services|Children receive speech-language services in the community. Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline.
100113|NCT01975220|O4|Outcome|High Dose, Fed: 3 Single Tablets|3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
99979|NCT01975922|O1|Outcome|Enhanced Milieu Teaching|"Parents receive 28 intervention sessions in which they learn to use language support strategies with their children.~Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline.~Enhanced Milieu Teaching: Enhanced Milieu Teaching (EMT) is a conversation-based model of early language intervention that uses child interest and initiations as opportunities to model and prompt language use in everyday contexts."
99980|NCT01975922|O2|Outcome|Community Services|Children receive speech-language services in the community. Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline.
99981|NCT01975922|O1|Outcome|Enhanced Milieu Teaching|"Parents receive 28 intervention sessions in which they learn to use language support strategies with their children.~Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline.~Enhanced Milieu Teaching: Enhanced Milieu Teaching (EMT) is a conversation-based model of early language intervention that uses child interest and initiations as opportunities to model and prompt language use in everyday contexts."
99982|NCT01975922|E2|Reported Event|Community Services|Children receive speech-language services in the community. Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline.
99983|NCT01975922|E1|Reported Event|Enhanced Milieu Teaching|"Parents receive 28 intervention sessions in which they learn to use language support strategies with their children.~Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline.~Enhanced Milieu Teaching: Enhanced Milieu Teaching (EMT) is a conversation-based model of early language intervention that uses child interest and initiations as opportunities to model and prompt language use in everyday contexts."
99984|NCT01975909|B3|Baseline|Total|Total of all reporting groups
99985|NCT01975909|B2|Baseline|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
99986|NCT01975909|B1|Baseline|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
99987|NCT01975909|P2|Participant Flow|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
99988|NCT01975909|P1|Participant Flow|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
99989|NCT01975909|O2|Outcome|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
99990|NCT01975909|O1|Outcome|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
99991|NCT01975909|O2|Outcome|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
99992|NCT01975909|O1|Outcome|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
100009|NCT01975675|P3|Participant Flow|LDV/SOF (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
99993|NCT01975909|O2|Outcome|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
99994|NCT01975909|O1|Outcome|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
99995|NCT01975909|O2|Outcome|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
99996|NCT01975909|O1|Outcome|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
99997|NCT01975909|O2|Outcome|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
99998|NCT01975909|O1|Outcome|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
99999|NCT01975909|O2|Outcome|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
100000|NCT01975909|O1|Outcome|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
100001|NCT01975909|E2|Reported Event|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
100002|NCT01975909|E1|Reported Event|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
100003|NCT01975675|B5|Baseline|Total|Total of all reporting groups
100004|NCT01975675|B4|Baseline|LDV/SOF+RBV (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
100005|NCT01975675|B3|Baseline|LDV/SOF (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
100006|NCT01975675|B2|Baseline|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
100007|NCT01975675|B1|Baseline|LDV/SOF (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
100010|NCT01975675|P2|Participant Flow|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus ribavirin (RBV) tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
100011|NCT01975675|P1|Participant Flow|LDV/SOF (Treatment Naive)|Treatment-naive participants received ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg fixed-dose combination (FDC) tablet once daily for up to 12 weeks.
100012|NCT01975675|O2|Outcome|LDV/SOF+RBV|Participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
100013|NCT01975675|O1|Outcome|LDV/SOF|Participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
100014|NCT01975675|O4|Outcome|LDV/SOF+RBV (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
100015|NCT01975675|O3|Outcome|LDV/SOF (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
100016|NCT01975675|O2|Outcome|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
100017|NCT01975675|O1|Outcome|LDV/SOF (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
100018|NCT01975675|O4|Outcome|LDV/SOF+RBV (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
100019|NCT01975675|O3|Outcome|LDV/SOF (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
100020|NCT01975675|O2|Outcome|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
100021|NCT01975675|O1|Outcome|LDV/SOF (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
100022|NCT01975675|O4|Outcome|LDV/SOF+RBV (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
100023|NCT01975675|O3|Outcome|LDV/SOF (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
100024|NCT01975675|O2|Outcome|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
100025|NCT01975675|O1|Outcome|LDV/SOF (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
100026|NCT01975675|O2|Outcome|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
100027|NCT01975675|O1|Outcome|LDV/SOF (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
100028|NCT01975675|E2|Reported Event|LDV/SOF+RBV|Participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
100029|NCT01975675|E1|Reported Event|LDV/SOF|Participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
100030|NCT01975467|B3|Baseline|Total|Total of all reporting groups
100031|NCT01975467|B2|Baseline|Test Group - Intramedullary Nail|"Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.~CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures."
100032|NCT01975467|B1|Baseline|Control Group - Nonoperative|Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
100033|NCT01975467|P2|Participant Flow|Test Group - Intramedullary Nail|"Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.~CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures."
100034|NCT01975467|P1|Participant Flow|Control Group - Nonoperative|Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
100035|NCT01975467|O2|Outcome|Test Group - Intramedullary Nail|"Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.~CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures."
100036|NCT01975467|O1|Outcome|Control Group - Nonoperative|Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
100037|NCT01975467|O2|Outcome|Test Group - Intramedullary Nail|"Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.~CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures."
100038|NCT01975467|O1|Outcome|Control Group - Nonoperative|Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
100039|NCT01975467|E2|Reported Event|Test Group - Intramedullary Nail|"Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.~CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures."
100040|NCT01975467|E1|Reported Event|Control Group - Nonoperative|Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
100041|NCT01975285|B3|Baseline|Total|Total of all reporting groups
100042|NCT01975285|B2|Baseline|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
100043|NCT01975285|B1|Baseline|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
100044|NCT01975285|P2|Participant Flow|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
100045|NCT01975285|P1|Participant Flow|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
100046|NCT01975285|O2|Outcome|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
100047|NCT01975285|O1|Outcome|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
100048|NCT01975285|O2|Outcome|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
100049|NCT01975285|O1|Outcome|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
100050|NCT01975285|O2|Outcome|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
100051|NCT01975285|O1|Outcome|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
100052|NCT01975285|O2|Outcome|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
100053|NCT01975285|O1|Outcome|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
100054|NCT01975285|O2|Outcome|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
100055|NCT01975285|O1|Outcome|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
100056|NCT01975285|E2|Reported Event|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
100057|NCT01975285|E1|Reported Event|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
100058|NCT01975246|B3|Baseline|Total|Total of all reporting groups
100059|NCT01975246|B2|Baseline|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
100060|NCT01975246|B1|Baseline|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
100061|NCT01975246|P2|Participant Flow|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
100062|NCT01975246|P1|Participant Flow|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
100063|NCT01975246|O2|Outcome|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
100064|NCT01975246|O1|Outcome|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
100065|NCT01975246|O2|Outcome|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
100066|NCT01975246|O1|Outcome|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
100067|NCT01975246|O2|Outcome|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
100068|NCT01975246|O1|Outcome|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
100069|NCT01975246|E2|Reported Event|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
100070|NCT01975246|E1|Reported Event|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
100071|NCT01975220|B4|Baseline|Total|Total of all reporting groups
100072|NCT01975220|B3|Baseline|Low Dose, Fasted|"2 fixed low dose combination (FDC) tablets vs. 4 single tablets under fasted conditions:~12.5 mg Empagliflozin / 750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets;~1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets"
100073|NCT01975220|B2|Baseline|High Dose, Fed|"1 fixed dose combination (FDC) tablet vs. 3 single tablets under fed conditions:~25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet;~1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets"
100074|NCT01975220|B1|Baseline|High Dose, Fasted|"1 fixed dose combination (FDC) tablet vs. 3 single tablets under fasted conditions:~25 mg Empagliflozin/1000 mg Metformin XR (extended release), FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet;~1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets"
100075|NCT01975220|P6|Participant Flow|Low Dose, Fasted: 4 Single Tablets First, Then 2 FDC Tablets|"4 single tablets first, then 2 fixed low dose combination (FDC) tablets under fasted conditions:~1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets;~12.5 mg Empagliflozin/750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets"
100114|NCT01975220|O3|Outcome|High Dose, Fed: 1 FDC Tablet|1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR
100076|NCT01975220|P5|Participant Flow|Low Dose, Fasted: 2 FDC Tablets First, Then 4 Single Tablets|"2 fixed low dose combination (FDC) tablets first, then 4 single tablets under fasted conditions:~12.5 mg Empagliflozin / 750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets;~1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets"
100077|NCT01975220|P4|Participant Flow|High Dose, Fed: 3 Single Tablets First, Then 1 FDC Tablet|"3 single tablets first, then 1 fixed dose combination (FDC) tablet under fed conditions:~1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets;~25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet"
100078|NCT01975220|P3|Participant Flow|High Dose, Fed: 1 FDC Tablet First, Then 3 Single Tablets|"1 fixed dose combination (FDC) tablet first, then 3 single tablets under fed conditions:~25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet;~1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets"
100079|NCT01975220|P2|Participant Flow|High Dose, Fasted: 3 Single Tablets First, Then 1 FDC Tablet|"3 single tablets first, then 1 fixed dose combination (FDC) tablet under fasted conditions:~1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets;~25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet"
100080|NCT01975220|P1|Participant Flow|High Dose, Fasted: 1 FDC Tablet First, Then 3 Single Tablets|"1 fixed dose combination (FDC) tablet first, then 3 single tablets under fasted conditions:~25 mg Empagliflozin/1000 mg Metformin extended release (XR), FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet;~1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets"
100081|NCT01975220|O6|Outcome|Low Dose, Fasted: 4 Single Tablets|4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR
100082|NCT01975220|O5|Outcome|Low Dose, Fasted: 2 FDC Tablets|2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR
100083|NCT01975220|O4|Outcome|High Dose, Fed: 3 Single Tablets|3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
100084|NCT01975220|O3|Outcome|High Dose, Fed: 1 FDC Tablet|1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR
100085|NCT01975220|O2|Outcome|High Dose, Fasted: 3 Single Tablets|3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
100086|NCT01975220|O1|Outcome|High Dose, Fasted: 1 FDC Tablet|1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)
100087|NCT01975220|O6|Outcome|Low Dose, Fasted: 4 Single Tablets|4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR
100088|NCT01975220|O5|Outcome|Low Dose, Fasted: 2 FDC Tablets|2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR
100089|NCT01975220|O4|Outcome|High Dose, Fed: 3 Single Tablets|3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
100090|NCT01975220|O3|Outcome|High Dose, Fed: 1 FDC Tablet|1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR
100091|NCT01975220|O2|Outcome|High Dose, Fasted: 3 Single Tablets|3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
100092|NCT01975220|O1|Outcome|High Dose, Fasted: 1 FDC Tablet|1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)
100093|NCT01975220|O6|Outcome|Low Dose, Fasted: 4 Single Tablets|4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR
100094|NCT01975220|O5|Outcome|Low Dose, Fasted: 2 FDC Tablets|2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR
100095|NCT01975220|O4|Outcome|High Dose, Fed: 3 Single Tablets|3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
100096|NCT01975220|O3|Outcome|High Dose, Fed: 1 FDC Tablet|1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR
100097|NCT01975220|O2|Outcome|High Dose, Fasted: 3 Single Tablets|3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
100098|NCT01975220|O1|Outcome|High Dose, Fasted: 1 FDC Tablet|1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)
100099|NCT01975220|O6|Outcome|Low Dose, Fasted: 4 Single Tablets|4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR
100100|NCT01975220|O5|Outcome|Low Dose, Fasted: 2 FDC Tablets|2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR
100101|NCT01975220|O4|Outcome|High Dose, Fed: 3 Single Tablets|3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
100102|NCT01975220|O3|Outcome|High Dose, Fed: 1 FDC Tablet|1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR
100103|NCT01975220|O2|Outcome|High Dose, Fasted: 3 Single Tablets|3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
100104|NCT01975220|O1|Outcome|High Dose, Fasted: 1 FDC Tablet|1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)
100105|NCT01975220|O6|Outcome|Low Dose, Fasted: 4 Single Tablets|4 single tablets, low dose, fasted: 1 x 25 mg tablets Empagliflozin / 3 x 500 mg tablets Metformin XR
100106|NCT01975220|O5|Outcome|Low Dose, Fasted: 2 FDC Tablets|2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR
100107|NCT01975220|O4|Outcome|High Dose, Fed: 3 Single Tablets|3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
100108|NCT01975220|O3|Outcome|High Dose, Fed: 1 FDC Tablet|1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR
100109|NCT01975220|O2|Outcome|High Dose, Fasted: 3 Single Tablets|3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
100110|NCT01975220|O1|Outcome|High Dose, Fasted: 1 FDC Tablet|1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)
100111|NCT01975220|O6|Outcome|Low Dose, Fasted: 4 Single Tablets|4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR
100112|NCT01975220|O5|Outcome|Low Dose, Fasted: 2 FDC Tablets|2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR
100115|NCT01975220|O2|Outcome|High Dose, Fasted: 3 Single Tablets|3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
100116|NCT01975220|O1|Outcome|High Dose, Fasted: 1 FDC Tablet|1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)
100117|NCT01975220|E6|Reported Event|Low Dose, Fasted: 4 Single Tablets|"4 single tablets under fed conditions:~1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets"
100118|NCT01975220|E5|Reported Event|Low Dose, Fasted: 2 FDC Tablets|"2 fixed dose combination (FDC) tablets under fasted conditions:~12.5 mg Empagliflozin / 750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets"
100119|NCT01975220|E4|Reported Event|High Dose, Fed: 3 Single Tablets|"3 single tablets under fed conditions:~1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets"
100120|NCT01975220|E3|Reported Event|High Dose, Fed: 1 FDC Tablet|"1 fixed dose combination (FDC) tablet under fed conditions:~25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet"
100121|NCT01975220|E2|Reported Event|High Dose, Fasted: 3 Single Tablets|"3 single tablets under fasted conditions:~1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets"
100122|NCT01975220|E1|Reported Event|High Dose, Fasted: 1 FDC Tablet|"1 fixed dose combination (FDC) tablet under fasted conditions:~25 mg Empagliflozin/1000 mg Metformin XR (extended release), FDC: Experimental, high dose Empagliflozin/Metformin XR, FDC tablet"
100123|NCT01975090|B1|Baseline|SENTRY IVC Filter Group|Patients were enrolled with documented deep vein thrombosis (DVT) or PE or at temporary risk of developing DVT or PE, and unable to use anticoagulation
100124|NCT01975090|P1|Participant Flow|SENTRY IVC Filter|Patients were enrolled with documented deep vein thrombosis (DVT) or PE or at temporary risk of developing DVT or PE, and unable to use anticoagulation.
100125|NCT01975090|O6|Outcome|Symptomatic Complications|Symptomatic Complications is the composite of Symptomatic Caval Thrombosis and Other Symptomatic Complications Requiring Invasive Intervention and filter-related death at 6 months
100126|NCT01975090|O5|Outcome|Filter Perforation|Core Lab reviewed imaging data at 6 month follow-up
100127|NCT01975090|O4|Outcome|Filter Fracture|Core Lab reviewed imaging data at 6 month follow-up
100128|NCT01975090|O3|Outcome|Filter Embolization|Core Lab reviewed imaging data at 6 month follow-up
100129|NCT01975090|O2|Outcome|Filter Migration|Core Lab reviewed imaging data at 6 month follow-up
100130|NCT01975090|O1|Outcome|Filter Tilting|Core Lab reviewed imaging data at 6 month follow-up
100131|NCT01975090|O1|Outcome|SENTRY IVC Filter|"The SENTRY IVC Bioconvertible Filter~SENTRY IVC Filter: The SENTRY IVC Bioconvertible Filter is designed to provide temporary protection to subjects at transient, high risk of pulmonary embolism. Following conclusion of the protection period The SENTRY filter bioconverts, and filter arms withdraw towards the IVC wall for incorporation; obviating the need for retrieval."
100132|NCT01975090|E1|Reported Event|SENTRY IVC Filter|Patients were enrolled with documented deep vein thrombosis (DVT) or PE or at temporary risk of developing DVT or PE, and unable to use anticoagulation.
100133|NCT01974895|B3|Baseline|Total|Total of all reporting groups
100134|NCT01974895|B2|Baseline|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
100135|NCT01974895|B1|Baseline|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
100136|NCT01974895|P2|Participant Flow|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
100137|NCT01974895|P1|Participant Flow|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
100138|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
100139|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
100140|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
100141|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
100142|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
100143|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
100144|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
100145|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
100146|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
100147|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
100148|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
100149|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
100150|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
100151|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
100152|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
100153|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
100154|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
100155|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
100156|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
100157|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
100158|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
100159|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
100160|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
100161|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
100162|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
100163|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
100164|NCT01974895|E2|Reported Event|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
100165|NCT01974895|E1|Reported Event|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
100166|NCT01974817|B1|Baseline|Vaccine|"Patients will receive one dose of 0.5 ml 13-valent conjugate pneumococcal vaccine (Prevnar-13) intra-muscularly.~13-valent conjugate pneumococcal vaccine: 0.5ml IM for one dose"
100167|NCT01974817|P1|Participant Flow|Vaccine|"Patients will receive one dose of 0.5 ml 13-valent conjugate pneumococcal vaccine (Prevnar-13) intra-muscularly.~13-valent conjugate pneumococcal vaccine: 0.5ml IM for one dose"
100168|NCT01974817|O1|Outcome|Vaccine Arm|A total of 17 patients received 1 dose of 13-valent pneumococcal conjugate vaccine.
100169|NCT01974817|E1|Reported Event|Vaccine Arm|A total of 17 patients received 1 dose of 13-valent pneumococcal conjugate vaccine.
100170|NCT01974752|B3|Baseline|Total|Total of all reporting groups
100171|NCT01974752|B2|Baseline|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
100172|NCT01974752|B1|Baseline|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
100173|NCT01974752|P2|Participant Flow|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
100174|NCT01974752|P1|Participant Flow|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
100175|NCT01974752|O2|Outcome|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
100176|NCT01974752|O1|Outcome|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
100177|NCT01974752|O2|Outcome|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
100178|NCT01974752|O1|Outcome|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
100179|NCT01974752|O2|Outcome|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
100180|NCT01974752|O1|Outcome|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
100181|NCT01974752|O2|Outcome|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
100182|NCT01974752|O1|Outcome|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
100183|NCT01974752|E2|Reported Event|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
100184|NCT01974752|E1|Reported Event|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
100185|NCT01974700|B3|Baseline|Total|Total of all reporting groups
100186|NCT01974700|B2|Baseline|No Anti-epileptic Treatment|
100187|NCT01974700|B1|Baseline|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
100188|NCT01974700|P2|Participant Flow|No Anti-epileptic Treatment|
100189|NCT01974700|P1|Participant Flow|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
100190|NCT01974700|O2|Outcome|No Anti-epileptic Treatment|
100191|NCT01974700|O1|Outcome|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
100192|NCT01974700|O2|Outcome|No Anti-epileptic Treatment|
100193|NCT01974700|O1|Outcome|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
100194|NCT01974700|O2|Outcome|No Anti-epileptic Treatment|
100195|NCT01974700|O1|Outcome|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
100196|NCT01974700|E2|Reported Event|No Anti-epileptic Treatment|
100197|NCT01974700|E1|Reported Event|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
100198|NCT01974323|B3|Baseline|Total|Total of all reporting groups
100199|NCT01974323|B2|Baseline|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100200|NCT01974323|B1|Baseline|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100201|NCT01974323|P2|Participant Flow|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100202|NCT01974323|P1|Participant Flow|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100203|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100204|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100205|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100206|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100207|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100208|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100209|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100210|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100211|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100212|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100213|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100214|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100215|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100216|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100217|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100218|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100219|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100220|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100221|NCT01974323|E2|Reported Event|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100222|NCT01974323|E1|Reported Event|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100223|NCT01974245|B3|Baseline|Total|Total of all reporting groups
100224|NCT01974245|B2|Baseline|Cholecalciferol|Cholecalciferol: 100,000 IU/week
100225|NCT01974245|B1|Baseline|Placebo|100 drops/week
100226|NCT01974245|P2|Participant Flow|Cholecalciferol|Cholecalciferol: 100,000 IU/week
100227|NCT01974245|P1|Participant Flow|Placebo|100 drops placebo solution/week
100228|NCT01974245|O2|Outcome|Cholecalciferol|Cholecalciferol: 100,000 IU/week for 12 weeks
100229|NCT01974245|O1|Outcome|Placebo|100 drops/week for 12 weeks
100230|NCT01974245|E2|Reported Event|Cholecalciferol|Cholecalciferol: 100,000 IU/week for 12 weeks
100231|NCT01974245|E1|Reported Event|Placebo|100 drops/week for 12 weeks
100232|NCT01974141|B3|Baseline|Total|Total of all reporting groups
100233|NCT01974141|B2|Baseline|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100234|NCT01974141|B1|Baseline|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100235|NCT01974141|P2|Participant Flow|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100236|NCT01974141|P1|Participant Flow|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100237|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100238|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100239|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100240|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100241|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100242|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100243|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100244|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100245|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100246|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100247|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100248|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100249|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100250|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100251|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100252|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100253|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100254|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100255|NCT01974141|E2|Reported Event|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100256|NCT01974141|E1|Reported Event|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
100257|NCT01974050|B1|Baseline|Text Message Monitoring|"Use of text messaging to monitor post-vaccination~Text message surveillance"
100258|NCT01974050|P1|Participant Flow|Text Message Monitoring|"Use of text messaging to monitor post-vaccination~Text message surveillance"
100259|NCT01974050|O1|Outcome|Text Message Monitoring|"Use of text messaging to monitor post-vaccination~Text message surveillance"
100260|NCT01974050|O1|Outcome|Text Message Monitoring|"Use of text messaging to monitor post-vaccination~Text message surveillance"
100261|NCT01974050|O1|Outcome|Text Message Monitoring|"Use of text messaging to monitor post-vaccination~Text message surveillance"
100262|NCT01974050|O1|Outcome|Text Message Monitoring|"Use of text messaging to monitor post-vaccination~Text message surveillance"
100263|NCT01974050|E1|Reported Event|Text Message Monitoring|"Use of text messaging to monitor post-vaccination~Text message surveillance"
100264|NCT01973777|B1|Baseline|IUB Inserted|"There is one arm of women who will have IUBs inserted~IUB: intrauterine contraceptive device"
100265|NCT01973777|P1|Participant Flow|IUB Inserted|"There is one arm of women who will have IUBs inserted~IUB: intrauterine contraceptive device"
100266|NCT01973777|O1|Outcome|IUB Inserted|"There is one arm of women who will have IUBs inserted~IUB: intrauterine contraceptive device"
100267|NCT01973777|O1|Outcome|IUB Inserted|"There is one arm of women who will have IUBs inserted~IUB: intrauterine contraceptive device"
100268|NCT01973777|O1|Outcome|IUB Inserted|"There is one arm of women who will have IUBs inserted~IUB: intrauterine contraceptive device"
100269|NCT01973777|E1|Reported Event|IUB Inserted|"There is one arm of women who will have IUBs inserted~IUB: intrauterine contraceptive device"
100270|NCT01973608|B5|Baseline|Total|Total of all reporting groups
100271|NCT01973608|B4|Baseline|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
100272|NCT01973608|B3|Baseline|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
100273|NCT01973608|B2|Baseline|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
100274|NCT01973608|B1|Baseline|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
100275|NCT01973608|P4|Participant Flow|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
100276|NCT01973608|P3|Participant Flow|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
100277|NCT01973608|P2|Participant Flow|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
100278|NCT01973608|P1|Participant Flow|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a single dose of 0.3 mg/kg as intravenous (IV) infusion over approximately 1 hour every 3 weeks (q3w) for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of Stereotactic Body Radiation Therapy (SBRT) to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions if one site was targeted subject received 3 fractions (1 per day) of 8 Gray (Gy) each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
100279|NCT01973608|O4|Outcome|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
100280|NCT01973608|O3|Outcome|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
100281|NCT01973608|O2|Outcome|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
100282|NCT01973608|O1|Outcome|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
100283|NCT01973608|O4|Outcome|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
100284|NCT01973608|O3|Outcome|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
100285|NCT01973608|O2|Outcome|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
100296|NCT01973595|B4|Baseline|No Almonds, Then Almonds (Children)|Children were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
100297|NCT01973595|B3|Baseline|Almonds, Then no Almonds (Children)|"Children were asked to consume 0.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste"
100286|NCT01973608|O1|Outcome|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a single dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
100287|NCT01973608|O4|Outcome|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
100288|NCT01973608|O3|Outcome|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
100289|NCT01973608|O2|Outcome|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
100290|NCT01973608|O1|Outcome|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a single dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
100291|NCT01973608|E4|Reported Event|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
100292|NCT01973608|E3|Reported Event|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
100293|NCT01973608|E2|Reported Event|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
100294|NCT01973608|E1|Reported Event|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a single dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
100295|NCT01973595|B5|Baseline|Total|Total of all reporting groups
100298|NCT01973595|B2|Baseline|No Almonds, Then Almonds (Parents)|Parents were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
100299|NCT01973595|B1|Baseline|Almonds, Then no Almonds (Parents)|"Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
100300|NCT01973595|P4|Participant Flow|No Almonds Then Almonds (Children)|Children were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
100301|NCT01973595|P3|Participant Flow|Almonds, Then no Almonds (Children)|"Children were asked to consume 0.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
100302|NCT01973595|P2|Participant Flow|No Almonds, Then Almonds (Parents)|Parents were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
100303|NCT01973595|P1|Participant Flow|Almonds, Then no Almonds (Parents)|"Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
100304|NCT01973595|O4|Outcome|No Almonds Consumption Control (Children)|"Children were asked not to consume almonds for 3 weeks.~Each group received the almond intervention and the no almond consumption control."
100305|NCT01973595|O3|Outcome|Almonds Consumption (Children)|"Children were asked to consume 0.5 ounces of almonds or almond paste per day for 3 weeks.~Each group received the almond intervention and the no almond consumption control.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
100306|NCT01973595|O2|Outcome|No Almonds Consumption Control (Parents)|"Parents were asked not to consume almonds for 3 weeks.~Each group received the almond intervention and the no almond consumption control."
100307|NCT01973595|O1|Outcome|Almonds Consumption (Parents)|"Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.~Each group received the almond intervention and the no almond consumption control.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
100308|NCT01973595|O2|Outcome|No Almond Consumption Control|"Participants were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.~Each group received the almond intervention and the no almond consumption control."
100309|NCT01973595|O1|Outcome|Almonds Consumption|"Participants were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.~Each group received the almond intervention and the no almond consumption control.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
100310|NCT01973595|O2|Outcome|No Almonds Consumption Control (Parents)|"Parents were asked not to consume almonds for 3 weeks.~Each group received the almond intervention and the no almond consumption control."
100311|NCT01973595|O1|Outcome|Almonds Consumption (Parents)|"Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.~Each group received the almond intervention and the no almond consumption control.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
100312|NCT01973595|O2|Outcome|No Almonds Consumption Control|"Participants were asked not to consume almonds for 3 weeks.~Each group received the almond intervention and the no almond consumption control."
100313|NCT01973595|O1|Outcome|Almonds Consumption|"Participants were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.~Each group received the almond intervention and the no almond consumption control.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
100314|NCT01973595|E2|Reported Event|No Almonds Consumption Control|"Participants were asked not to consume almonds for 3 weeks.~Each group received the almond intervention and the no almond consumption control."
100315|NCT01973595|E1|Reported Event|Almonds Consumption|"Participants were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.~Each group received the almond intervention and the no almond consumption control.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
100316|NCT01973491|B1|Baseline|ATX-MS-1467|Subjects received ATX-MS-1467 50 mcg, 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
100317|NCT01973491|P1|Participant Flow|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
100318|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
100319|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
100320|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
100321|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
100322|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
100323|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
100324|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
100325|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
100326|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
100327|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
100328|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
100329|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
100330|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
100331|NCT01973491|E1|Reported Event|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
100332|NCT01973439|B1|Baseline|Single Arm|This is a single arm crossover study First intervention: PK assessment while on Twice Daily Abacavir Second intervention: PK assessment while on Once Daily Abacavir
100333|NCT01973439|P1|Participant Flow|Single Arm|"This is a single arm crossover study~st intervention: PK assessment while on Twice Daily Abacavir~nd intervention: PK assessment while on Once Daily Abacavir"
100334|NCT01973439|O1|Outcome|Single Arm|This is a single arm study. First intervention: PK assessment of Twice Daily Abacavir (Week 0) Second intervention: PK assessment of Once Daily Abacavir (Week 4)
100335|NCT01973439|O1|Outcome|Single Arm|This is a single arm study. First intervention: PK assessment of Twice Daily Abacavir (Week 0) Second intervention: PK assessment of Once Daily Abacavir (Week 4)
100336|NCT01973439|O1|Outcome|Single Arm|This is a single arm study. First intervention: PK assessment of Twice Daily Abacavir (Week 0) Second intervention: PK assessment of Once Daily Abacavir (Week 4)
100337|NCT01973439|O1|Outcome|Single Arm|This is a single arm study. First intervention: PK assessment of Twice Daily Abacavir (Week 0) Second intervention: PK assessment of Once Daily Abacavir (Week 4)
100338|NCT01973439|E1|Reported Event|Abacavir Once Versus Twice Daily|This is a single arm study. Intervention 1: PK assessment while on Twice Daily Abacavir (Week 0) Intervention 2: PK assessment while on Once Daily Abacavir (Week 4)
100339|NCT01973413|B3|Baseline|Total|Total of all reporting groups
100340|NCT01973413|B2|Baseline|Camp Study|"The second phase of this proposal was the in-camp studies. The same health care providers that conducted the inpatient studies conducted the camp studies. They monitored all campers on closed-loop control in real-time. Participants were randomized to either closed-loop (experimental) or sensor-augmented therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session (i.e. on DiAs CTR every other night). Since participants were not always successfully completing a closed-loop control night, the pattern could not hold throughout the entire trial. Thus, there are numerous intervention sequences.~Those assigned to DiAs closed-loop control were remotely monitored throughout the night. Those assigned to the control group were not monitored remotely overnight, but they were wearing Dexcom G4 Platinum sensors with active low and high sensor glucose alarms."
100341|NCT01973413|B1|Baseline|Inpatient Study|The first phase of this study tested the feasibility of initializing the DiAs CTR system in a clinical research center. We tested the procedures that would occur with the camp studies, from consenting the subjects, obtaining morning glucose readings, initializing the sensor in the early afternoon, having some light activity in the evening, a bedtime snack, and initializing the closed-loop system within 30 minutes before they go to bed. We also tested how the system would perform using the same calibration and blood glucose monitoring that would be done at camp. In the inpatient study mimicked some camp activities by having the subjects have 20-30 minutes of aerobic activity in the afternoon and in the evening after dinner. The data from the inpatient studies was reviewed by the Data Safety Monitoring Board (DSMB) before we proceeded with the Phase 2 summer camp studies.
100342|NCT01973413|P2|Participant Flow|Camp Study|"The second phase of this proposal was the in-camp studies. The same health care providers that conducted the inpatient studies conducted the camp studies. They monitored all campers on closed-loop control in real-time. Participants were randomized to either closed-loop (experimental) or sensor-augmented therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session (i.e. on DiAs CTR every other night). Since participants were not always successfully completing a closed-loop control night, the pattern could not hold throughout the entire trial. Thus, there are numerous intervention sequences.~Those assigned to DiAs closed-loop control were remotely monitored throughout the night. Those assigned to the control group were not monitored remotely overnight, but they were wearing Dexcom G4 Platinum sensors with active low and high sensor glucose alarms."
100363|NCT01973387|E2|Reported Event|Rituximab|Treatment Arm B received rituximab intravenous (IV) infusion 375 milligram per meter square (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m^2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m^2 on Day 1 of Cycles 3-6 (Weeks 9-24).
100364|NCT01973387|E1|Reported Event|Ibrutinib|Treatment Arm A received 420 milligram (mg) ibrutinib (3*140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
100365|NCT01973348|B5|Baseline|Total|Total of all reporting groups
100473|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
100343|NCT01973413|P1|Participant Flow|Inpatient Study|The first phase of this study tested the feasibility of initializing the DiAs CTR system in a clinical research center. We tested the procedures that would occur with the camp studies, from consenting the subjects, obtaining morning glucose readings, initializing the sensor in the early afternoon, having some light activity in the evening, a bedtime snack, and initializing the closed-loop system within 30 minutes before they go to bed. We also tested how the system would perform using the same calibration and blood glucose monitoring that would be done at camp. In the inpatient study mimicked some camp activities by having the subjects have 20-30 minutes of aerobic activity in the afternoon and in the evening after dinner. The data from the inpatient studies was reviewed by the Data Safety Monitoring Board (DSMB) before we proceeded with the Phase 2 summer camp studies.
100344|NCT01973413|O2|Outcome|Control: Sensor-Augmented Pump Therapy|Subjects will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. They will not use the Diabetes Assistant (DiAs) nor have remote monitoring.
100345|NCT01973413|O1|Outcome|Experimental: Closed-Loop Control|"Subjects will use the Diabetes Assistant (DiAs) and will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. Subjects will be remotely monitored throughout the night in real time.~Diabetes Assistant (DiAs): The Control-to-Range (CTR)algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range."
100346|NCT01973413|O2|Outcome|Control: Sensor-Augmented Pump Therapy|Subjects will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. They will not use the Diabetes Assistant (DiAs) nor have remote monitoring.
100347|NCT01973413|O1|Outcome|Experimental: Closed-Loop Control|"Subjects will use the Diabetes Assistant (DiAs) and will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. Subjects will be remotely monitored throughout the night in real time.~Diabetes Assistant (DiAs): The Control-to-Range (CTR) algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range."
100348|NCT01973413|O2|Outcome|Control: Sensor-Augmented Pump Therapy|Subjects will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. They will not use the Diabetes Assistant (DiAs) nor have remote monitoring.
100349|NCT01973413|O1|Outcome|Experimental: Closed-Loop Control|"Subjects will use the Diabetes Assistant (DiAs) and will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. Subjects will be remotely monitored throughout the night in real time.~Diabetes Assistant (DiAs): The Control-to-Range (CTR) algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range."
100350|NCT01973413|E2|Reported Event|Control: Sensor-Augmented Pump Therapy|Subjects will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. They will not use the Diabetes Assistant (DiAs) nor have remote monitoring.
100351|NCT01973413|E1|Reported Event|Experimental: Closed-Loop Control|"Subjects will use the Diabetes Assistant (DiAs) and will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. Subjects will be remotely monitored throughout the night in real time.~Diabetes Assistant (DiAs): The Control-to-Range (CTR)algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range."
100352|NCT01973387|B3|Baseline|Total|Total of all reporting groups
100353|NCT01973387|B2|Baseline|Rituximab|Treatment Arm B received rituximab intravenous (IV) infusion 375 milligram per meter square (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m^2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m^2 on Day 1 of Cycles 3-6 (Weeks 9-24).
100354|NCT01973387|B1|Baseline|Ibrutinib|Treatment Arm A received 420 milligram (mg) ibrutinib (3*140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
100355|NCT01973387|P2|Participant Flow|Rituximab|Treatment Arm B received rituximab intravenous (IV) infusion 375 milligram per meter square (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m^2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m^2 on Day 1 of Cycles 3-6 (Weeks 9-24).
100356|NCT01973387|P1|Participant Flow|Ibrutinib|Treatment Arm A received 420 milligram (mg) ibrutinib (3*140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
100357|NCT01973387|O2|Outcome|Rituximab|Treatment Arm B received rituximab intravenous (IV) infusion 375 milligram per meter square (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m^2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m^2 on Day 1 of Cycles 3-6 (Weeks 9-24).
100358|NCT01973387|O1|Outcome|Ibrutinib|Treatment Arm A received 420 milligram (mg) ibrutinib (3*140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
100359|NCT01973387|O2|Outcome|Rituximab|Treatment Arm B received rituximab intravenous (IV) infusion 375 milligram per meter square (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m^2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m^2 on Day 1 of Cycles 3-6 (Weeks 9-24).
100360|NCT01973387|O1|Outcome|Ibrutinib|Treatment Arm A received 420 milligram (mg) ibrutinib (3*140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
100361|NCT01973387|O2|Outcome|Rituximab|Treatment Arm B received rituximab intravenous (IV) infusion 375 milligram per meter square (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m^2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m^2 on Day 1 of Cycles 3-6 (Weeks 9-24).
100362|NCT01973387|O1|Outcome|Ibrutinib|Treatment Arm A received 420 milligram (mg) ibrutinib (3*140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
100423|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
100366|NCT01973348|B4|Baseline|6-hour Eye Patching|"6-hour eye patching for severe amblyopia~6-hour patching: 6-hour patching for severe amblyopia"
100367|NCT01973348|B3|Baseline|12-hour AmblyZ Glasses|"12-hour AmblyZ glasses for severe amblyopia~12-hour AmblyZ glasses: 12-hour AmblyZ glasses for severe amblyopia"
100368|NCT01973348|B2|Baseline|2-hour Eye Patching|"2-hour eye patching for moderate amblyopia~2-hour patching: 2-hour patching for moderate amblyopia"
100369|NCT01973348|B1|Baseline|4-hour AmblyZ Glasses|"4-hour AmblyZ glasses for moderate amblyopia~4-hour AmblyZ glasses: 4-hour AmblyZ glasses for moderate amblyopia"
100370|NCT01973348|P4|Participant Flow|6-hour Eye Patching|"6-hour eye patching for severe amblyopia~6-hour patching: 6-hour patching for severe amblyopia"
100371|NCT01973348|P3|Participant Flow|12-hour AmblyZ Glasses|"12-hour AmblyZ glasses for severe amblyopia~12-hour AmblyZ glasses: 12-hour AmblyZ glasses for severe amblyopia"
100372|NCT01973348|P2|Participant Flow|2-hour Eye Patching|"2-hour eye patching for moderate amblyopia~2-hour patching: 2-hour patching for moderate amblyopia"
100373|NCT01973348|P1|Participant Flow|4-hour AmblyZ Glasses|"4-hour AmblyZ glasses for moderate amblyopia~4-hour AmblyZ glasses: 4-hour AmblyZ glasses for moderate amblyopia"
100374|NCT01973348|O4|Outcome|6-hour Eye Patching|"6-hour eye patching for severe amblyopia~6-hour patching: 6-hour patching for severe amblyopia"
100375|NCT01973348|O3|Outcome|12-hour AmblyZ Glasses|"12-hour AmblyZ glasses for severe amblyopia~12-hour AmblyZ glasses: 12-hour AmblyZ glasses for severe amblyopia"
100376|NCT01973348|O2|Outcome|2-hour Eye Patching|"2-hour eye patching for moderate amblyopia~2-hour patching: 2-hour patching for moderate amblyopia"
100377|NCT01973348|O1|Outcome|4-hour AmblyZ Glasses|"4-hour AmblyZ glasses for moderate amblyopia~4-hour AmblyZ glasses: 4-hour AmblyZ glasses for moderate amblyopia"
100378|NCT01973348|O4|Outcome|6-hour Eye Patching|"6-hour eye patching for severe amblyopia~6-hour patching: 6-hour patching for severe amblyopia"
100379|NCT01973348|O3|Outcome|12-hour AmblyZ Glasses|"12-hour AmblyZ glasses for severe amblyopia~12-hour AmblyZ glasses: 12-hour AmblyZ glasses for severe amblyopia"
100380|NCT01973348|O2|Outcome|2-hour Eye Patching|"2-hour eye patching for moderate amblyopia~2-hour patching: 2-hour patching for moderate amblyopia"
100381|NCT01973348|O1|Outcome|4-hour AmblyZ Glasses|"4-hour AmblyZ glasses for moderate amblyopia~4-hour AmblyZ glasses: 4-hour AmblyZ glasses for moderate amblyopia"
100382|NCT01973348|O4|Outcome|6-hour Eye Patching|"6-hour eye patching for severe amblyopia~6-hour patching: 6-hour patching for severe amblyopia"
100383|NCT01973348|O3|Outcome|12-hour AmblyZ Glasses|"12-hour AmblyZ glasses for severe amblyopia~12-hour AmblyZ glasses: 12-hour AmblyZ glasses for severe amblyopia"
100384|NCT01973348|O2|Outcome|2-hour Eye Patching|"2-hour eye patching for moderate amblyopia~2-hour patching: 2-hour patching for moderate amblyopia"
100385|NCT01973348|O1|Outcome|4-hour AmblyZ Glasses|"4-hour AmblyZ glasses for moderate amblyopia~4-hour AmblyZ glasses: 4-hour AmblyZ glasses for moderate amblyopia"
100386|NCT01973348|E4|Reported Event|6-hour Eye Patching|"6-hour eye patching for severe amblyopia~6-hour patching: 6-hour patching for severe amblyopia"
100387|NCT01973348|E3|Reported Event|12-hour AmblyZ Glasses|"12-hour AmblyZ glasses for severe amblyopia~12-hour AmblyZ glasses: 12-hour AmblyZ glasses for severe amblyopia"
100388|NCT01973348|E2|Reported Event|2-hour Eye Patching|"2-hour eye patching for moderate amblyopia~2-hour patching: 2-hour patching for moderate amblyopia"
100389|NCT01973348|E1|Reported Event|4-hour AmblyZ Glasses|"4-hour AmblyZ glasses for moderate amblyopia~4-hour AmblyZ glasses: 4-hour AmblyZ glasses for moderate amblyopia"
100390|NCT01973231|B3|Baseline|Total|Total of all reporting groups
100391|NCT01973231|B2|Baseline|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
100392|NCT01973231|B1|Baseline|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
100393|NCT01973231|P2|Participant Flow|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
100394|NCT01973231|P1|Participant Flow|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
100395|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
100396|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
100397|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
100424|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
100398|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
100399|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
100400|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
100401|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
100402|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
100403|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
100404|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
100405|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
100406|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
100407|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
100408|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
100409|NCT01973231|E2|Reported Event|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
100410|NCT01973231|E1|Reported Event|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
100411|NCT01973218|B3|Baseline|Total|Total of all reporting groups
100412|NCT01973218|B2|Baseline|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
100413|NCT01973218|B1|Baseline|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
100414|NCT01973218|P2|Participant Flow|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
100415|NCT01973218|P1|Participant Flow|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
100416|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
100417|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
100418|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
100419|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
100420|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
100421|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
100422|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
100426|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
100427|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
100428|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
100429|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
100430|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
100431|NCT01973218|O1|Outcome|rMenb|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
100432|NCT01973218|E3|Reported Event|Total|Total of subjects
100433|NCT01973218|E2|Reported Event|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
100434|NCT01973218|E1|Reported Event|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
100435|NCT01973205|B3|Baseline|Total|Total of all reporting groups
100436|NCT01973205|B2|Baseline|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg~Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
100437|NCT01973205|B1|Baseline|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets~Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
100438|NCT01973205|P2|Participant Flow|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg~Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
100439|NCT01973205|P1|Participant Flow|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets~Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
100440|NCT01973205|O2|Outcome|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg~Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
100441|NCT01973205|O1|Outcome|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets~Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
100442|NCT01973205|O2|Outcome|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg~Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
100443|NCT01973205|O1|Outcome|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets~Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
100444|NCT01973205|O2|Outcome|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg~Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
100445|NCT01973205|O1|Outcome|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets~Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
100446|NCT01973205|O2|Outcome|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg~Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
100447|NCT01973205|O1|Outcome|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets~Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
100448|NCT01973205|E2|Reported Event|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg~Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
100449|NCT01973205|E1|Reported Event|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets~Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
100450|NCT01972776|B7|Baseline|Total|Total of all reporting groups
100451|NCT01972776|B6|Baseline|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
100452|NCT01972776|B5|Baseline|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
100453|NCT01972776|B4|Baseline|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
100454|NCT01972776|B3|Baseline|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
100455|NCT01972776|B2|Baseline|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
100456|NCT01972776|B1|Baseline|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
100457|NCT01972776|P6|Participant Flow|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
100458|NCT01972776|P5|Participant Flow|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
100459|NCT01972776|P4|Participant Flow|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
100460|NCT01972776|P3|Participant Flow|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
100461|NCT01972776|P2|Participant Flow|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
100462|NCT01972776|P1|Participant Flow|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
100463|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
100464|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
100465|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
100466|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
100467|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
100468|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
100469|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
100470|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
100471|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
100472|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
100477|NCT01972776|O4|Outcome|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
100478|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
100479|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
100480|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
100481|NCT01972776|O4|Outcome|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
100482|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
100483|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
100484|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
100485|NCT01972776|O4|Outcome|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
100486|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
100487|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
100488|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
100489|NCT01972776|O4|Outcome|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
100490|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
100491|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
100492|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
100493|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
100494|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
100495|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
100496|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
100497|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
100498|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
100499|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
100500|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
100501|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
100502|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
100503|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
100504|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
100505|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
100506|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
100507|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
100508|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
100509|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
100510|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
100511|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
100512|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
100513|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
100514|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
100515|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
100516|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
100517|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
100518|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
100519|NCT01972776|O4|Outcome|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
100520|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
100521|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
100522|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
100523|NCT01972776|E6|Reported Event|Part 2:QBM076 B.I.D Placebo|Part 2:QBM076 B.I.D Placebo
100524|NCT01972776|E5|Reported Event|Part 2: QBM076 B.I.D 150 mg|Part 2: QBM076 B.I.D 150 mg
100525|NCT01972776|E4|Reported Event|Part 1: Placebo|Part 1: Placebo
100526|NCT01972776|E3|Reported Event|Part 1: QBM076 B.I.D 150 mg|Part 1: QBM076 B.I.D 150 mg
100527|NCT01972776|E2|Reported Event|Part 1: QBM076 B.I.D 75 mg|Part 1: QBM076 B.I.D 75 mg
100528|NCT01972776|E1|Reported Event|Part 1: QBM076 B.I.D 25 mg|Part 1: QBM076 B.I.D 25 mg
100529|NCT01972659|B3|Baseline|Total|Total of all reporting groups
100530|NCT01972659|B2|Baseline|Sugammadex and Magnesium Sulphate|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery~Magnesium Sulphate: Experimental :~50 mg/kg bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
100531|NCT01972659|B1|Baseline|Sugammadex and Placebo|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery~placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
100532|NCT01972659|P2|Participant Flow|Sugammadex and Magnesium Sulphate|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery~Magnesium Sulphate: Experimental :~50 mg/kg bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
100533|NCT01972659|P1|Participant Flow|Sugammadex and Placebo|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery~placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
100534|NCT01972659|O2|Outcome|Sugammadex and Magnesium Sulphate|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery~Magnesium Sulphate: Experimental :~50 mg/kg bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
100535|NCT01972659|O1|Outcome|Sugammadex and Placebo|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery~placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
100536|NCT01972659|E2|Reported Event|Sugammadex and Magnesium Sulphate|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery~Magnesium Sulphate: Experimental :~50 mg/kg bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
100537|NCT01972659|E1|Reported Event|Sugammadex and Placebo|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery~placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
100538|NCT01972568|B4|Baseline|Total|Total of all reporting groups
100539|NCT01972568|B3|Baseline|Placebo|Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
100540|NCT01972568|B2|Baseline|Atacicept 150 mg|Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
100541|NCT01972568|B1|Baseline|Atacicept 75 mg|Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
100542|NCT01972568|P3|Participant Flow|Placebo|Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
100543|NCT01972568|P2|Participant Flow|Atacicept 150 mg|Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
100544|NCT01972568|P1|Participant Flow|Atacicept 75 mg|Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
100545|NCT01972568|O3|Outcome|Placebo|Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
100546|NCT01972568|O2|Outcome|Atacicept 150 mg|Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
100547|NCT01972568|O1|Outcome|Atacicept 75 mg|Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
100548|NCT01972568|O3|Outcome|Placebo|Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
100549|NCT01972568|O2|Outcome|Atacicept 150 mg|Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
100550|NCT01972568|O1|Outcome|Atacicept 75 mg|Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
100551|NCT01972568|O3|Outcome|Placebo|Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
100552|NCT01972568|O2|Outcome|Atacicept 150 mg|Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
100553|NCT01972568|O1|Outcome|Atacicept 75 mg|Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
100554|NCT01972568|O3|Outcome|Placebo|Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
100555|NCT01972568|O2|Outcome|Atacicept 150 mg|Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
100556|NCT01972568|O1|Outcome|Atacicept 75 mg|Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
100557|NCT01972568|O3|Outcome|Placebo|Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
100558|NCT01972568|O2|Outcome|Atacicept 150 mg|Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
100559|NCT01972568|O1|Outcome|Atacicept 75 mg|Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
100560|NCT01972568|O3|Outcome|Placebo|Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
100561|NCT01972568|O2|Outcome|Atacicept 150 mg|Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
100562|NCT01972568|O1|Outcome|Atacicept 75 mg|Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
100563|NCT01972568|O3|Outcome|Placebo|Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
100564|NCT01972568|O2|Outcome|Atacicept 150 mg|Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
100565|NCT01972568|O1|Outcome|Atacicept 75 mg|Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
100566|NCT01972568|O3|Outcome|Placebo|Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
100567|NCT01972568|O2|Outcome|Atacicept 150 mg|Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
100568|NCT01972568|O1|Outcome|Atacicept 75 mg|Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
100569|NCT01972568|O3|Outcome|Placebo|Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
100570|NCT01972568|O2|Outcome|Atacicept 150 mg|Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
100571|NCT01972568|O1|Outcome|Atacicept 75 mg|Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
100572|NCT01972568|O3|Outcome|Placebo|Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
100573|NCT01972568|O2|Outcome|Atacicept 150 mg|Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
100574|NCT01972568|O1|Outcome|Atacicept 75 mg|Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
100575|NCT01972568|E3|Reported Event|Placebo|Subjects received placebo matched to atacicept as once-weekly subcutaneous injection for 24 weeks.
100576|NCT01972568|E2|Reported Event|Atacicept 150 mg|Subjects received atacicept 150 mg as once-weekly subcutaneous injection for 24 weeks.
100577|NCT01972568|E1|Reported Event|Atacicept 75 mg|Subjects received atacicept 75 milligram (mg) as once-weekly subcutaneous injection for 24 weeks.
100578|NCT01972529|B5|Baseline|Total|Total of all reporting groups
100579|NCT01972529|B4|Baseline|40 mg Avatrombopag (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100580|NCT01972529|B3|Baseline|40 mg Placebo (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100581|NCT01972529|B2|Baseline|60 mg Avatrombopag, (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100582|NCT01972529|B1|Baseline|60 mg Placebo (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/liters (L) took three 20 milligrams (mg) matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100583|NCT01972529|P4|Participant Flow|40 mg Avatrombopag (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100584|NCT01972529|P3|Participant Flow|40 mg Placebo (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100585|NCT01972529|P2|Participant Flow|60 mg Avatrombopag, (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the elective procedure.
100586|NCT01972529|P1|Participant Flow|60 mg Placebo (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/liters (L) took three 20 milligrams (mg) (60 mg total) matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100587|NCT01972529|O4|Outcome|40 mg Avatrombopag (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100588|NCT01972529|O3|Outcome|40 mg Placebo (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100589|NCT01972529|O2|Outcome|60 mg Avatrombopag, (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100590|NCT01972529|O1|Outcome|60 mg Placebo (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100591|NCT01972529|O4|Outcome|40 mg Avatrombopag (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100592|NCT01972529|O3|Outcome|40 mg Placebo (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100593|NCT01972529|O2|Outcome|60 mg Avatrombopag, (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100594|NCT01972529|O1|Outcome|60 mg Placebo (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100595|NCT01972529|O4|Outcome|40 mg Avatrombopag (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100596|NCT01972529|O3|Outcome|40 mg Placebo (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100597|NCT01972529|O2|Outcome|60 mg Avatrombopag, (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100851|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
100598|NCT01972529|O1|Outcome|60 mg Placebo (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100599|NCT01972529|O4|Outcome|40 mg Avatrombopag (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100600|NCT01972529|O3|Outcome|40 mg Placebo (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100601|NCT01972529|O2|Outcome|60 mg Avatrombopag, (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100602|NCT01972529|O1|Outcome|60 mg Placebo (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100603|NCT01972529|O4|Outcome|40 mg Avatrombopag (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100604|NCT01972529|O3|Outcome|40 mg Placebo (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100605|NCT01972529|O2|Outcome|60 mg Avatrombopag, (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100606|NCT01972529|O1|Outcome|60 mg Placebo (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/liters (L ) took three 20 milligrams (mg) matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100607|NCT01972529|E4|Reported Event|40 mg Avatrombopag (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100608|NCT01972529|E3|Reported Event|40 mg Placebo (Higher Baseline Platelet Count)|Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100609|NCT01972529|E2|Reported Event|60 mg Avatrombopag, (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100610|NCT01972529|E1|Reported Event|60 mg Placebo (Lower Baseline Platelet Count)|Participants with a baseline platelet count of less than 40 x 10^9/liters (L) took three 20 milligrams (mg) matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
100611|NCT01972516|B3|Baseline|Total|Total of all reporting groups
100612|NCT01972516|B2|Baseline|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
100613|NCT01972516|B1|Baseline|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
100614|NCT01972516|P2|Participant Flow|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
100615|NCT01972516|P1|Participant Flow|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
100616|NCT01972516|O2|Outcome|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
100617|NCT01972516|O1|Outcome|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
100618|NCT01972516|O2|Outcome|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
100619|NCT01972516|O1|Outcome|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
100620|NCT01972516|O2|Outcome|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
100621|NCT01972516|O1|Outcome|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
100622|NCT01972516|O2|Outcome|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
100623|NCT01972516|O1|Outcome|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
100624|NCT01972516|O2|Outcome|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
100625|NCT01972516|O1|Outcome|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
100626|NCT01972516|E2|Reported Event|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
100627|NCT01972516|E1|Reported Event|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
100628|NCT01972464|B3|Baseline|Total|Total of all reporting groups
100629|NCT01972464|B2|Baseline|Progesterone|"In this group women will receive oral micronized progesterone twice a day.~Progesterone"
100630|NCT01972464|B1|Baseline|Placebo|"In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.~Placebo"
100631|NCT01972464|P2|Participant Flow|Progesterone|"In this group women will receive oral micronized progesterone twice a day.~Progesterone"
100632|NCT01972464|P1|Participant Flow|Placebo|"In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.~Placebo"
100633|NCT01972464|O2|Outcome|Progesterone|"In this group women will receive oral micronized progesterone twice a day.~Progesterone"
100634|NCT01972464|O1|Outcome|Placebo|"In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.~Placebo"
100635|NCT01972464|O2|Outcome|Progesterone|"In this group women will receive oral micronized progesterone twice a day.~Progesterone: oral micronized progesterone"
100636|NCT01972464|O1|Outcome|Placebo|"In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.~Placebo"
100637|NCT01972464|O2|Outcome|Progesterone|"In this group women will receive oral micronized progesterone twice a day.~Progesterone"
100638|NCT01972464|O1|Outcome|Placebo|"In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.~Placebo"
100639|NCT01972464|O2|Outcome|Progesterone|"In this group women will receive oral micronized progesterone twice a day.~Progesterone"
100640|NCT01972464|O1|Outcome|Placebo|"In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.~Placebo"
100641|NCT01972464|O2|Outcome|Progesterone|"In this group women will receive oral micronized progesterone twice a day.~Progesterone"
100642|NCT01972464|O1|Outcome|Placebo|"In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.~Placebo"
100643|NCT01972464|E2|Reported Event|Progesterone|"In this group women will receive oral micronized progesterone twice a day.~Progesterone"
100644|NCT01972464|E1|Reported Event|Placebo|"In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.~Placebo"
100645|NCT01972438|B3|Baseline|Total|Total of all reporting groups
100646|NCT01972438|B2|Baseline|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
100647|NCT01972438|B1|Baseline|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
100648|NCT01972438|P2|Participant Flow|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
100649|NCT01972438|P1|Participant Flow|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
100650|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
100651|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
100852|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
100853|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
100652|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
100653|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
100654|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
100655|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
100656|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
100657|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
100658|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
100659|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
100660|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
100661|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
100662|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
100663|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
100664|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
100665|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
100666|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
100667|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
100668|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
100669|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
100670|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
100671|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
100672|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
100673|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
100674|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
100675|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
100676|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
100854|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
100677|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
100678|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
100679|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
100680|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
100681|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
100682|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
100683|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
100684|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
100685|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
100686|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
100687|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
100688|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
100689|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
100690|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
100691|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
100692|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
100693|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
100694|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
100695|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
100696|NCT01972438|E4|Reported Event|No Intervention|Adverse event occurred prior to participants receiving either intervention. Neither ASEDs nor normal saline eye drops were being taken when the event occurred.
100697|NCT01972438|E3|Reported Event|ASEDs or Saline|Adverse event occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops daily if desired.
100698|NCT01972438|E2|Reported Event|Saline|Adverse event occurred when participants were receiving control (normal saline) eye drops daily during the crossover period (first six months) of the study.
100699|NCT01972438|E1|Reported Event|ASEDs|Adverse event occurred when participants were receiving autologous serum eye drops (ASEDs) daily during the crossover period (first six months) of the study.
100700|NCT01972152|B1|Baseline|Total Study Group|Includes all 30 randomized subjects
100701|NCT01972152|P6|Participant Flow|Lilly 1 mg First, Then G-Pen(TM) 1 mg, Then G-Pen(TM) 0.5 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 2 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 3.
100702|NCT01972152|P5|Participant Flow|Lilly 1 mg First, Then G-Pen(TM) 0.5 mg, Then G-Pen(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 2 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 3.
100703|NCT01972152|P4|Participant Flow|G-Pen(TM) 1 mg First, Then Lilly 1 mg, Then G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection of at treatment visit 2 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg SC injection at treatment visit 3.
100704|NCT01972152|P3|Participant Flow|G-Pen(TM) 1 mg First, Then G-Pen(TM) 0.5 mg , Then Lilly 1 mg|G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg SC injection at treatment visit 2 followed by a 3-14 day washout, Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection at treatment visit 3.
100705|NCT01972152|P2|Participant Flow|G-Pen(TM) 0.5 mg First, Then Lilly 1 mg, Then G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection at treatment visit 2, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 3.
100706|NCT01972152|P1|Participant Flow|G-Pen(TM) 0.5 mg First, Then G-Pen(TM) 1 mg, Then Lilly 1 mg|G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 2 followed by a 3-14 day washout, Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection at treatment visit 3.
100707|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
100708|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
100709|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
100710|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
100711|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
100712|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
100713|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
100714|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
100715|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
100716|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
100717|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
100718|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
100719|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
100720|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
100721|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
100722|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
100723|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
100724|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
100725|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
100726|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
100727|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
100728|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
100729|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
100730|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
100731|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
100732|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
100733|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
100734|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|"Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection~G-Pen(TM) 1 mg~Lilly Glucagon(TM) 1 mg~G-Pen(TM) 0.5 mg"
100735|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|"G-Pen(TM) (glucagon injection), single 0.5 mg SC injection~G-Pen(TM) 1 mg~Lilly Glucagon(TM) 1 mg~G-Pen(TM) 0.5 mg"
100736|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|"G-Pen(TM) (glucagon injection), single 1 mg SC injection~G-Pen(TM) 1 mg~Lilly Glucagon(TM) 1 mg~G-Pen(TM) 0.5 mg"
100737|NCT01972152|E3|Reported Event|Lilly Glucagon(TM) 1 mg|"Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection~G-Pen(TM) 1 mg~Lilly Glucagon(TM) 1 mg~G-Pen(TM) 0.5 mg"
100738|NCT01972152|E2|Reported Event|G-Pen(TM) 0.5 mg|"G-Pen(TM) (glucagon injection), single 0.5 mg SC injection~G-Pen(TM) 1 mg~Lilly Glucagon(TM) 1 mg~G-Pen(TM) 0.5 mg"
100739|NCT01972152|E1|Reported Event|G-Pen(TM) 1 mg|"G-Pen(TM) (glucagon injection), single 1 mg SC injection~G-Pen(TM) 1 mg~Lilly Glucagon(TM) 1 mg~G-Pen(TM) 0.5 mg"
100740|NCT01971723|B3|Baseline|Total|Total of all reporting groups
100741|NCT01971723|B2|Baseline|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
100755|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
100742|NCT01971723|B1|Baseline|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
100743|NCT01971723|P2|Participant Flow|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
100744|NCT01971723|P1|Participant Flow|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
100745|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
100746|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
100747|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
100748|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
100749|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
100750|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
100751|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
100752|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
100753|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
100754|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
100841|NCT01971554|P3|Participant Flow|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
100842|NCT01971554|P2|Participant Flow|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
100756|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
100757|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
100758|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
100759|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
100760|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
100761|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
100762|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
100763|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
100764|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
100765|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
100766|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
100767|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
100768|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
100843|NCT01971554|P1|Participant Flow|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
100844|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
100769|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
100770|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
100771|NCT01971723|E2|Reported Event|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
100772|NCT01971723|E1|Reported Event|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
100773|NCT01971645|B4|Baseline|Total|Total of all reporting groups
100774|NCT01971645|B3|Baseline|Group M|"Group M patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group M will also receive a gluteal intramuscular injection of 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg).~Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
100775|NCT01971645|B2|Baseline|Group R|"Group R patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group R will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
100776|NCT01971645|B1|Baseline|Group D|"Group D patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) with 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) perineurally for their femoral block. Group D will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).~Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
100777|NCT01971645|P3|Participant Flow|Intramuscular Dexamethasone Group|"Intramuscular group patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group M will also receive a gluteal intramuscular injection of 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg).~Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
100778|NCT01971645|P2|Participant Flow|Ropivacaine Group|"Ropivacaine group patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group R will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
100779|NCT01971645|P1|Participant Flow|Perineural Dexamethasone Group|"Perineural group patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) with 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) perineurally for their femoral block. Group D will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).~Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
100780|NCT01971645|O3|Outcome|Group M|"Group M patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group M will also receive a gluteal intramuscular injection of 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg).~Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
100781|NCT01971645|O2|Outcome|Group R|"Group R patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group R will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
100782|NCT01971645|O1|Outcome|Group D|"Group D patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) with 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) perineurally for their femoral block. Group D will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).~Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
100845|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
100783|NCT01971645|O3|Outcome|Group M|"Group M patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group M will also receive a gluteal intramuscular injection of 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg).~Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
100784|NCT01971645|O2|Outcome|Group R|"Group R patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group R will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
100785|NCT01971645|O1|Outcome|Group D|"Group D patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) with 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) perineurally for their femoral block. Group D will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).~Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
100786|NCT01971645|E3|Reported Event|Group M|"Group M patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group M will also receive a gluteal intramuscular injection of 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg).~Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
100787|NCT01971645|E2|Reported Event|Group R|"Group R patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group R will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
100788|NCT01971645|E1|Reported Event|Group D|"Group D patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) with 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) perineurally for their femoral block. Group D will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).~Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.~Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally."
100789|NCT01971593|B1|Baseline|Total Study Group|Crossover study, all patients pooled for baseline analysis
100790|NCT01971593|P2|Participant Flow|Eplerenone Before Drug Free Period|"Patients will be given eplerenone 50mg for 12 months, followed by a 3 month drug free period~Eplerenone"
100791|NCT01971593|P1|Participant Flow|Eplerenone After Drug Free Period|"Patients will be given eplerenone 50mg for 12 months after an initial 3 month drug free period~Eplerenone"
100792|NCT01971593|O1|Outcome|Total Study Group|Change from baseline at time of drug initiation
100793|NCT01971593|O1|Outcome|Total Study Group|Change from baseline at time of drug initiation
100794|NCT01971593|O1|Outcome|Total Study Group|Change from baseline at time of drug initiation
100795|NCT01971593|O1|Outcome|Total Study Group|Change from baseline at time of drug initiation
100796|NCT01971593|O1|Outcome|Total Study Group|Change from baseline at time of drug initiation
100797|NCT01971593|O1|Outcome|Total Study Group|Change from baseline at time of drug initiation
100798|NCT01971593|E1|Reported Event|Eplerenone Period|Change from baseline at time of drug initiation
100799|NCT01971580|B3|Baseline|Total|Total of all reporting groups
100800|NCT01971580|B2|Baseline|Placebo First, Ambrisentan Second|"These patients will be randomized to have placebo during the first study period, and ambrisentan during the second study period.~Ambrisentan"
100801|NCT01971580|B1|Baseline|Ambrisentan First, Placebo Second|"These patients will be randomized to have ambrisentan during the first study period, and placebo during the second study period.~Ambrisentan"
100802|NCT01971580|P2|Participant Flow|Placebo First, Ambrisentan Second|"These patients will be randomized to have placebo during the first study period, and ambrisentan during the second study period.~Ambrisentan"
100803|NCT01971580|P1|Participant Flow|Ambrisentan First, Placebo Second|"These patients will be randomized to have ambrisentan during the first study period, and placebo during the second study period.~Ambrisentan"
100804|NCT01971580|O2|Outcome|On Placebo|Baseline compared to after placebo therapy
100805|NCT01971580|O1|Outcome|On Ambrisentan Therapy|Baseline compared to after period of ambrisentan therapy
100806|NCT01971580|O2|Outcome|On Placebo|After Placebo compared to baseline
100807|NCT01971580|O1|Outcome|On Ambrisentan Therapy|After Ambrisentan compared to baseline
100808|NCT01971580|E2|Reported Event|On Placebo|Events that occurred while on placebo therapy
100809|NCT01971580|E1|Reported Event|On Ambrisentan Therapy|Events that occurred while on ambrisentan therapy
100810|NCT01971567|B3|Baseline|Total|Total of all reporting groups
100811|NCT01971567|B2|Baseline|Placebo|"Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.~HIRREM"
100812|NCT01971567|B1|Baseline|HIRREM|"High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.~HIRREM"
100813|NCT01971567|P2|Participant Flow|Placebo|"Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.~HIRREM"
100846|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
100814|NCT01971567|P1|Participant Flow|HIRREM|"High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.~HIRREM"
100815|NCT01971567|O2|Outcome|Placebo|"Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.~HIRREM"
100816|NCT01971567|O1|Outcome|HIRREM|"High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.~HIRREM"
100817|NCT01971567|O2|Outcome|Placebo|"Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.~HIRREM"
100818|NCT01971567|O1|Outcome|HIRREM|"High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.~HIRREM"
100819|NCT01971567|O2|Outcome|Placebo|"Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.~HIRREM"
100820|NCT01971567|O1|Outcome|HIRREM|"High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.~HIRREM"
100821|NCT01971567|O2|Outcome|Placebo|"Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.~HIRREM"
100822|NCT01971567|O1|Outcome|HIRREM|"High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.~HIRREM"
100823|NCT01971567|O2|Outcome|Placebo|"Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.~HIRREM"
100824|NCT01971567|O1|Outcome|HIRREM|"High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.~HIRREM"
100825|NCT01971567|O2|Outcome|Placebo|"Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.~HIRREM"
100826|NCT01971567|O1|Outcome|HIRREM|"High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.~HIRREM"
100827|NCT01971567|O2|Outcome|Placebo|"Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.~HIRREM"
100828|NCT01971567|O1|Outcome|HIRREM|"High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.~HIRREM"
100829|NCT01971567|O2|Outcome|Placebo|"Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.~HIRREM"
100830|NCT01971567|O1|Outcome|HIRREM|"High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.~HIRREM"
100831|NCT01971567|O2|Outcome|Placebo|"Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.~HIRREM"
100832|NCT01971567|O1|Outcome|HIRREM|"High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.~HIRREM"
100833|NCT01971567|E2|Reported Event|Placebo|"Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.~HIRREM"
100834|NCT01971567|E1|Reported Event|HIRREM|"High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.~HIRREM"
100835|NCT01971554|B5|Baseline|Total|Total of all reporting groups
100836|NCT01971554|B4|Baseline|Placebo|Placebo once daily for 14 consecutive days
100837|NCT01971554|B3|Baseline|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
100838|NCT01971554|B2|Baseline|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
100839|NCT01971554|B1|Baseline|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
100840|NCT01971554|P4|Participant Flow|Placebo|Placebo once daily for 14 consecutive days
100993|NCT01970878|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg
100855|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
100856|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
100857|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
100858|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
100859|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
100860|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
100861|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
100862|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
100863|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
100864|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
100865|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
100866|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
100867|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
100868|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
100869|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
100870|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
100871|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
100872|NCT01971554|E4|Reported Event|Placebo|Placebo once daily for 14 consecutive days
100873|NCT01971554|E3|Reported Event|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
100874|NCT01971554|E2|Reported Event|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
100875|NCT01971554|E1|Reported Event|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
100876|NCT01971385|B4|Baseline|Total|Total of all reporting groups
100877|NCT01971385|B3|Baseline|Placebo Solution|"Patients in placebo group will be given dimethyl sulfoxide.~Placebo solution"
100878|NCT01971385|B2|Baseline|0.5% Squaric Acid|"0.5% Squaric Acid solution disolved in dimethyl sulfoxide will be applied~Squaric Acid solution"
100879|NCT01971385|B1|Baseline|0.2% Squaric Acid|"0.2% Squaric Acid solution disolved in dimethyl sulfoxide will be applied~Squaric Acid solution"
100880|NCT01971385|P3|Participant Flow|Placebo Solution|"Patients in placebo group will be given dimethyl sulfoxide.~Placebo solution"
100881|NCT01971385|P2|Participant Flow|0.5% Squaric Acid|"0.5% Squaric Acid solution disolved in dimethyl sulfoxide will be applied~Squaric Acid solution"
100882|NCT01971385|P1|Participant Flow|0.2% Squaric Acid|"0.2% Squaric Acid solution disolved in dimethyl sulfoxide will be applied~Squaric Acid solution"
100883|NCT01971385|O2|Outcome|Placebo Solution|"Patients in placebo group will be given dimethyl sulfoxide.~Placebo solution"
100884|NCT01971385|O1|Outcome|2% Squaric Acid Sensitization|"2% Squaric Acid solution will be applied for sensitization to the inner arm.~Squaric Acid solution"
100885|NCT01971385|E3|Reported Event|Placebo Solution|"Patients in placebo group will be given dimethyl sulfoxide.~Placebo solution"
100886|NCT01971385|E2|Reported Event|0.5% Squaric Acid|"0.5% Squaric Acid solution disolved in dimethyl sulfoxide will be applied~Squaric Acid solution"
100887|NCT01971385|E1|Reported Event|0.2% Squaric Acid|"0.2% Squaric Acid solution disolved in dimethyl sulfoxide will be applied~Squaric Acid solution"
100888|NCT01971255|B3|Baseline|Total|Total of all reporting groups
100889|NCT01971255|B2|Baseline|Low Titer (HAI < 1:40)|Enrolled Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 at the time of planned inoculation and were placed in this group.
100890|NCT01971255|B1|Baseline|High Titer (HAI > 1:40)|Enrolled Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 at the time of planned inoculation were placed in this group.
100891|NCT01971255|P2|Participant Flow|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers at the time of challenge of <1:40 were assigned to this group.
100892|NCT01971255|P1|Participant Flow|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers at the time of challenge of =1:40 were assigned to this group.
100893|NCT01971255|O2|Outcome|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
100894|NCT01971255|O1|Outcome|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
100895|NCT01971255|O2|Outcome|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
100896|NCT01971255|O1|Outcome|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
100897|NCT01971255|O2|Outcome|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
100898|NCT01971255|O1|Outcome|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
100899|NCT01971255|O2|Outcome|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
100900|NCT01971255|O1|Outcome|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
100901|NCT01971255|O2|Outcome|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
100902|NCT01971255|O1|Outcome|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
100903|NCT01971255|O2|Outcome|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
100904|NCT01971255|O1|Outcome|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
100905|NCT01971255|E2|Reported Event|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
100994|NCT01970878|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
100906|NCT01971255|E1|Reported Event|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
100907|NCT01971203|B3|Baseline|Total|Total of all reporting groups
100908|NCT01971203|B2|Baseline|Placebo Plus CBT|matching placebo pills plus 16 weeks of Cognitive Behavioral Therapy
100909|NCT01971203|B1|Baseline|Seroquel XR Plus CBT|"Participants were required to take a minimum of one 50 mg pill of quetiapine XR a day with an intended titration schedule reaching 150 mg over the first three weeks, adding one pill per week. . If a participant could not tolerate the increased dose, then dosage was decreased to either one or two pills a day.~All participants who completed the study received 16 sessions of CBT and discontinued medication at 16 weeks. Although conducted weekly, CBT and medication schedules did not always terminate at the same time."
100910|NCT01971203|P2|Participant Flow|Placebo Plus CBT|matching placebo pills plus 16 weeks of Cognitive Behavioral Therapy
100911|NCT01971203|P1|Participant Flow|Seroquel XR Plus CBT|"Participants were required to take a minimum of one 50 mg pill of quetiapine XR a day with an intended titration schedule reaching 150 mg over the first three weeks, adding one pill per week. . If a participant could not tolerate the increased dose, then dosage was decreased to either one or two pills a day.~All participants who completed the study received 16 sessions of CBT and discontinued medication at 16 weeks. Although conducted weekly, CBT and medication schedules did not always terminate at the same time."
100912|NCT01971203|O2|Outcome|Placebo Plus CBT|matching placebo pills plus 16 weeks of Cognitive Behavioral Therapy
100913|NCT01971203|O1|Outcome|Seroquel XR Plus CBT|Participants were required to take a minimum of one 50 mg pill of quetiapine XR a day.
100914|NCT01971203|O2|Outcome|Placebo Plus CBT|matching placebo pills plus 16 weeks of Cognitive Behavioral Therapy
100915|NCT01971203|O1|Outcome|Seroquel XR Plus CBT|Participants were required to take a minimum of one 50 mg pill of quetiapine XR a day.
100916|NCT01971203|O2|Outcome|Placebo Plus CBT|matching placebo pills plus 16 weeks of Cognitive Behavioral Therapy
100917|NCT01971203|O1|Outcome|Seroquel XR Plus CBT|Participants were required to take a minimum of one 50 mg pill of quetiapine XR a day.
100918|NCT01971203|O2|Outcome|Placebo Plus CBT|matching placebo pills plus 16 weeks of Cognitive Behavioral Therapy
100919|NCT01971203|O1|Outcome|Seroquel XR Plus CBT|Participants were required to take a minimum of one 50 mg pill of quetiapine XR a day.
100920|NCT01971203|E2|Reported Event|Placebo Plus CBT|matching placebo pills plus 16 weeks of Cognitive Behavioral Therapy
100921|NCT01971203|E1|Reported Event|Seroquel XR Plus CBT|Participants were required to take a minimum of one 50 mg pill of quetiapine XR a day.
100922|NCT01971086|B1|Baseline|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
100923|NCT01971086|P1|Participant Flow|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
100924|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
100925|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
100926|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
100927|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
100928|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
100929|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
100930|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
100931|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
100932|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
100933|NCT01971086|E1|Reported Event|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
100934|NCT01970995|B4|Baseline|Total|Total of all reporting groups
100935|NCT01970995|B3|Baseline|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
100936|NCT01970995|B2|Baseline|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
100937|NCT01970995|B1|Baseline|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
100938|NCT01970995|P3|Participant Flow|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
100939|NCT01970995|P2|Participant Flow|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
100940|NCT01970995|P1|Participant Flow|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
100941|NCT01970995|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
100995|NCT01970878|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
100942|NCT01970995|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
100943|NCT01970995|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
100944|NCT01970995|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
100945|NCT01970995|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
100946|NCT01970995|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
100947|NCT01970995|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
100948|NCT01970995|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
100949|NCT01970995|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
100950|NCT01970995|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
100951|NCT01970995|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
100952|NCT01970995|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
100953|NCT01970995|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
100954|NCT01970995|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
100955|NCT01970995|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
100956|NCT01970995|E3|Reported Event|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
100957|NCT01970995|E2|Reported Event|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
100958|NCT01970995|E1|Reported Event|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
100959|NCT01970982|B4|Baseline|Total|Total of all reporting groups
100960|NCT01970982|B3|Baseline|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
100961|NCT01970982|B2|Baseline|Conventional Cigarette (CC)|Ad libitum use of Subject's own preferred brand of CC for 5 days in confinement
100962|NCT01970982|B1|Baseline|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
100963|NCT01970982|P3|Participant Flow|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
100964|NCT01970982|P2|Participant Flow|Conventional Cigarette (CC)|Ad libitum use of Subject's own preferred brand of CC for 5 days in confinement
100965|NCT01970982|P1|Participant Flow|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
100966|NCT01970982|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
100967|NCT01970982|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
100968|NCT01970982|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
100969|NCT01970982|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
100970|NCT01970982|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
100971|NCT01970982|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
100972|NCT01970982|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
100973|NCT01970982|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
100974|NCT01970982|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
100975|NCT01970982|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
100976|NCT01970982|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
100977|NCT01970982|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
100978|NCT01970982|E4|Reported Event|Enrolled But Not Randomized|Subjects who tried the THS 2.2 at Admission (Day -2) but were not randomized in 1 of the 3 arms as they were back-up subjects
100979|NCT01970982|E3|Reported Event|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
100980|NCT01970982|E2|Reported Event|Conventional Cigarette (CC)|Ad libitum use of Subject's own preferred brand of CC for 5 days in confinement
100981|NCT01970982|E1|Reported Event|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
100982|NCT01970878|B5|Baseline|Total|Total of all reporting groups
100983|NCT01970878|B4|Baseline|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
100984|NCT01970878|B3|Baseline|FF MDI (PT005)|FF MDI 9.6 mcg
100985|NCT01970878|B2|Baseline|GP MDI (PT001)|GP MDI 14.4 mcg
100986|NCT01970878|B1|Baseline|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
100987|NCT01970878|P4|Participant Flow|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
100988|NCT01970878|P3|Participant Flow|FF MDI (PT005)|FF MDI 9.6 mcg
100989|NCT01970878|P2|Participant Flow|GP MDI (PT001)|GP MDI 14.4 mcg
100990|NCT01970878|P1|Participant Flow|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
100991|NCT01970878|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
100992|NCT01970878|O3|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
100999|NCT01970878|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
101000|NCT01970878|O3|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
101001|NCT01970878|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg
101002|NCT01970878|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
101003|NCT01970878|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
101004|NCT01970878|O3|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
101005|NCT01970878|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg
101006|NCT01970878|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
101007|NCT01970878|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
101008|NCT01970878|O3|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
101009|NCT01970878|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg
101010|NCT01970878|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
101011|NCT01970878|E4|Reported Event|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
101012|NCT01970878|E3|Reported Event|FF MDI (PT005)|FF MDI 9.6 mcg
101013|NCT01970878|E2|Reported Event|GP MDI (PT001)|GP MDI 14.4 mcg
101014|NCT01970878|E1|Reported Event|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
101015|NCT01970865|B18|Baseline|Total|Total of all reporting groups
101016|NCT01970865|B17|Baseline|Japan Lead-In Cohort (LIC)|Few Japanese participants were given PF-06463922 100 mg orally once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal to evaluate safety of PF-06463922 in Japanese participants, in order to support inclusion of Japanese participants in Phase 2.
101017|NCT01970865|B16|Baseline|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101018|NCT01970865|B15|Baseline|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101019|NCT01970865|B14|Baseline|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101020|NCT01970865|B13|Baseline|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101021|NCT01970865|B12|Baseline|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101022|NCT01970865|B11|Baseline|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101023|NCT01970865|B10|Baseline|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101024|NCT01970865|B9|Baseline|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101025|NCT01970865|B8|Baseline|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101026|NCT01970865|B7|Baseline|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101027|NCT01970865|B6|Baseline|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101028|NCT01970865|B5|Baseline|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101029|NCT01970865|B4|Baseline|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101438|NCT01970865|O1|Outcome|ALK Positive Population (Phase 1)|This reporting arm includes all Phase 1 participants who had documented ALK rearrangement.
101030|NCT01970865|B3|Baseline|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101031|NCT01970865|B2|Baseline|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101032|NCT01970865|B1|Baseline|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101033|NCT01970865|P17|Participant Flow|Japan Lead-In Cohort (LIC)|Few Japanese participants were given PF-06463922 100 mg orally once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal to evaluate safety of PF-06463922 in Japanese participants, in order to support inclusion of Japanese participants in Phase 2.
101034|NCT01970865|P16|Participant Flow|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101035|NCT01970865|P15|Participant Flow|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101036|NCT01970865|P14|Participant Flow|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101037|NCT01970865|P13|Participant Flow|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101038|NCT01970865|P12|Participant Flow|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101039|NCT01970865|P11|Participant Flow|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101040|NCT01970865|P10|Participant Flow|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101041|NCT01970865|P9|Participant Flow|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101042|NCT01970865|P8|Participant Flow|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101043|NCT01970865|P7|Participant Flow|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101044|NCT01970865|P6|Participant Flow|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101045|NCT01970865|P5|Participant Flow|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101046|NCT01970865|P4|Participant Flow|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101047|NCT01970865|P3|Participant Flow|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101048|NCT01970865|P2|Participant Flow|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101977|NCT01968811|E1|Reported Event|Avance Foam, Abdominal Dressing Kit|Avance Foam dressing kit
101049|NCT01970865|P1|Participant Flow|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101050|NCT01970865|O6|Outcome|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101051|NCT01970865|O5|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101052|NCT01970865|O4|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101053|NCT01970865|O3|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101054|NCT01970865|O2|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101055|NCT01970865|O1|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101056|NCT01970865|O6|Outcome|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101057|NCT01970865|O5|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101058|NCT01970865|O4|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101059|NCT01970865|O3|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101060|NCT01970865|O2|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101061|NCT01970865|O1|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101062|NCT01970865|O6|Outcome|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101165|NCT01970865|O7|Outcome|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101978|NCT01968694|B3|Baseline|Total|Total of all reporting groups
101063|NCT01970865|O5|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101064|NCT01970865|O4|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101065|NCT01970865|O3|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101066|NCT01970865|O2|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101067|NCT01970865|O1|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101068|NCT01970865|O6|Outcome|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101069|NCT01970865|O5|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101070|NCT01970865|O4|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101071|NCT01970865|O3|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101072|NCT01970865|O2|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101073|NCT01970865|O1|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101074|NCT01970865|O6|Outcome|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101075|NCT01970865|O5|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101076|NCT01970865|O4|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101481|NCT01970488|B2|Baseline|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
101077|NCT01970865|O3|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101078|NCT01970865|O2|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101079|NCT01970865|O1|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101080|NCT01970865|O6|Outcome|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101081|NCT01970865|O5|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101082|NCT01970865|O4|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101083|NCT01970865|O3|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101084|NCT01970865|O2|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101085|NCT01970865|O1|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101086|NCT01970865|O6|Outcome|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101087|NCT01970865|O5|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101088|NCT01970865|O4|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101089|NCT01970865|O3|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101090|NCT01970865|O2|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101091|NCT01970865|O1|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101092|NCT01970865|O16|Outcome|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101093|NCT01970865|O15|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101094|NCT01970865|O14|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101095|NCT01970865|O13|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101096|NCT01970865|O12|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101097|NCT01970865|O11|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101098|NCT01970865|O10|Outcome|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101099|NCT01970865|O9|Outcome|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101100|NCT01970865|O8|Outcome|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101101|NCT01970865|O7|Outcome|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101102|NCT01970865|O6|Outcome|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101103|NCT01970865|O5|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101104|NCT01970865|O4|Outcome|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101105|NCT01970865|O3|Outcome|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101106|NCT01970865|O2|Outcome|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101107|NCT01970865|O1|Outcome|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101108|NCT01970865|O16|Outcome|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101166|NCT01970865|O6|Outcome|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101109|NCT01970865|O15|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101110|NCT01970865|O14|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101111|NCT01970865|O13|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101112|NCT01970865|O12|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101113|NCT01970865|O11|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101114|NCT01970865|O10|Outcome|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101115|NCT01970865|O9|Outcome|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101116|NCT01970865|O8|Outcome|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101117|NCT01970865|O7|Outcome|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101118|NCT01970865|O6|Outcome|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101119|NCT01970865|O5|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101120|NCT01970865|O4|Outcome|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101121|NCT01970865|O3|Outcome|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101122|NCT01970865|O2|Outcome|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101123|NCT01970865|O1|Outcome|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101124|NCT01970865|O16|Outcome|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101125|NCT01970865|O15|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101126|NCT01970865|O14|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101167|NCT01970865|O5|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
102659|NCT01965561|O3|Outcome|JETT|Use of Junctional Emergency Treatment Tool (JETT)
101127|NCT01970865|O13|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101128|NCT01970865|O12|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101129|NCT01970865|O11|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101130|NCT01970865|O10|Outcome|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101131|NCT01970865|O9|Outcome|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101132|NCT01970865|O8|Outcome|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101133|NCT01970865|O7|Outcome|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101134|NCT01970865|O6|Outcome|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101135|NCT01970865|O5|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101136|NCT01970865|O4|Outcome|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101137|NCT01970865|O3|Outcome|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101138|NCT01970865|O2|Outcome|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101139|NCT01970865|O1|Outcome|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101140|NCT01970865|O16|Outcome|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101141|NCT01970865|O15|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101142|NCT01970865|O14|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101143|NCT01970865|O13|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101144|NCT01970865|O12|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
102660|NCT01965561|O2|Outcome|AAJT|Use of Abdominal Aortic and Junctional Tourniquet (AAJT)
101145|NCT01970865|O11|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101146|NCT01970865|O10|Outcome|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101147|NCT01970865|O9|Outcome|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101148|NCT01970865|O8|Outcome|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101149|NCT01970865|O7|Outcome|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101150|NCT01970865|O6|Outcome|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101151|NCT01970865|O5|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101152|NCT01970865|O4|Outcome|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101153|NCT01970865|O3|Outcome|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101154|NCT01970865|O2|Outcome|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101155|NCT01970865|O1|Outcome|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101156|NCT01970865|O16|Outcome|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101157|NCT01970865|O15|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101158|NCT01970865|O14|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101159|NCT01970865|O13|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101160|NCT01970865|O12|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101161|NCT01970865|O11|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101162|NCT01970865|O10|Outcome|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101163|NCT01970865|O9|Outcome|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101164|NCT01970865|O8|Outcome|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101168|NCT01970865|O4|Outcome|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101169|NCT01970865|O3|Outcome|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101170|NCT01970865|O2|Outcome|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101171|NCT01970865|O1|Outcome|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101172|NCT01970865|O16|Outcome|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101173|NCT01970865|O15|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101174|NCT01970865|O14|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101175|NCT01970865|O13|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101176|NCT01970865|O12|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101177|NCT01970865|O11|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101178|NCT01970865|O10|Outcome|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101179|NCT01970865|O9|Outcome|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101180|NCT01970865|O8|Outcome|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101181|NCT01970865|O7|Outcome|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101182|NCT01970865|O6|Outcome|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101183|NCT01970865|O5|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101184|NCT01970865|O4|Outcome|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101185|NCT01970865|O3|Outcome|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101186|NCT01970865|O2|Outcome|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101187|NCT01970865|O1|Outcome|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
102661|NCT01965561|O1|Outcome|CRoC|Use of Combat Ready Clamp (CRoC)
101188|NCT01970865|O16|Outcome|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101189|NCT01970865|O15|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101190|NCT01970865|O14|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101191|NCT01970865|O13|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101192|NCT01970865|O12|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101193|NCT01970865|O11|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101194|NCT01970865|O10|Outcome|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101195|NCT01970865|O9|Outcome|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101196|NCT01970865|O8|Outcome|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101197|NCT01970865|O7|Outcome|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101198|NCT01970865|O6|Outcome|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101199|NCT01970865|O5|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101200|NCT01970865|O4|Outcome|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101201|NCT01970865|O3|Outcome|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101202|NCT01970865|O2|Outcome|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101203|NCT01970865|O1|Outcome|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101204|NCT01970865|O6|Outcome|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101205|NCT01970865|O5|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101281|NCT01970865|O5|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101206|NCT01970865|O4|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101207|NCT01970865|O3|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101208|NCT01970865|O2|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101209|NCT01970865|O1|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101210|NCT01970865|O6|Outcome|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101211|NCT01970865|O5|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101212|NCT01970865|O4|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101213|NCT01970865|O3|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101214|NCT01970865|O2|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101215|NCT01970865|O1|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101216|NCT01970865|O5|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101217|NCT01970865|O4|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101218|NCT01970865|O3|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101219|NCT01970865|O2|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101220|NCT01970865|O1|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101221|NCT01970865|O5|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101222|NCT01970865|O4|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101223|NCT01970865|O3|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101224|NCT01970865|O2|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101225|NCT01970865|O1|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101226|NCT01970865|O1|Outcome|Phase 2 and Japan LIC PK Analysis Set|PK parameters of PF-06463922 were determined for a small subset of Phase 2 participants and Japan LIC. These participants received PF-06463922 100 mg orally QD and were combined into 1 reporting group for PK analysis. Japan LIC was not included in single-dose PK analysis, ie, they did not contribute to Day -7 data.
101227|NCT01970865|O1|Outcome|Phase 2 and Japan LIC PK Analysis Set|PK parameters of PF-06463922 were determined for a small subset of Phase 2 participants and Japan LIC. These participants received PF-06463922 100 mg orally QD and were combined into 1 reporting group for PK analysis. Japan LIC was not included in single-dose PK analysis, ie, they did not contribute to Day -7 data.
101228|NCT01970865|O1|Outcome|Phase 2 and Japan LIC PK Analysis Set|PK parameters of PF-06463922 were determined for a small subset of Phase 2 participants and Japan LIC. These participants received PF-06463922 100 mg orally QD and were combined into 1 reporting group for PK analysis. Japan LIC was not included in single-dose PK analysis, ie, they did not contribute to Day -7 data.
101229|NCT01970865|O1|Outcome|Phase 2 and Japan LIC PK Analysis Set|PK parameters of PF-06463922 were determined for a small subset of Phase 2 participants and Japan LIC. These participants received PF-06463922 100 mg orally QD and were combined into 1 reporting group for PK analysis. Japan LIC was not included in single-dose PK analysis, ie, they did not contribute to Day -7 data.
101230|NCT01970865|O1|Outcome|Phase 2 and Japan LIC PK Analysis Set|PK parameters of PF-06463922 were determined for a small subset of Phase 2 participants and Japan LIC. These participants received PF-06463922 100 mg orally QD and were combined into 1 reporting group for PK analysis. Japan LIC was not included in single-dose PK analysis, ie, they did not contribute to Day -7 data.
101231|NCT01970865|O1|Outcome|Phase 2 and Japan LIC PK Analysis Set|PK parameters of PF-06463922 were determined for a small subset of Phase 2 participants and Japan LIC. These participants received PF-06463922 100 mg orally QD and were combined into 1 reporting group for PK analysis. Japan LIC was not included in single-dose PK analysis, ie, they did not contribute to Day -7 data.
101232|NCT01970865|O1|Outcome|Phase 2 and Japan LIC PK Analysis Set|PK parameters of PF-06463922 were determined for a small subset of Phase 2 participants and Japan LIC. These participants received PF-06463922 100 mg orally QD and were combined into 1 reporting group for PK analysis. Japan LIC was not included in single-dose PK analysis, ie, they did not contribute to Day -7 data.
101233|NCT01970865|O1|Outcome|Phase 2 and Japan LIC PK Analysis Set|PK parameters of PF-06463922 were determined for a small subset of Phase 2 participants and Japan LIC. These participants received PF-06463922 100 mg orally QD and were combined into 1 reporting group for PK analysis. Japan LIC was not included in single-dose PK analysis, ie, they did not contribute to Day -7 data.
101234|NCT01970865|O1|Outcome|Phase 2 and Japan LIC PK Analysis Set|PK parameters of PF-06463922 were determined for a small subset of Phase 2 participants and Japan LIC. These participants received PF-06463922 100 mg orally QD and were combined into 1 reporting group for PK analysis. Japan LIC was not included in single-dose PK analysis, ie, they did not contribute to Day -7 data.
101235|NCT01970865|O6|Outcome|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101282|NCT01970865|O4|Outcome|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
103224|NCT01963845|E1|Reported Event|Placebo|Sitagliptin-matched placebo tablet
101236|NCT01970865|O5|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101237|NCT01970865|O4|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101238|NCT01970865|O3|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101239|NCT01970865|O2|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101240|NCT01970865|O1|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101241|NCT01970865|O6|Outcome|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101242|NCT01970865|O5|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101243|NCT01970865|O4|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101244|NCT01970865|O3|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101245|NCT01970865|O2|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101246|NCT01970865|O1|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101247|NCT01970865|O1|Outcome|Phase 2 ITT Population|This reporting group includes all Phase 2 participants in the ITT analysis set.
101248|NCT01970865|O6|Outcome|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101249|NCT01970865|O5|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101250|NCT01970865|O4|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
103225|NCT01963767|B3|Baseline|Total|Total of all reporting groups
101251|NCT01970865|O3|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101252|NCT01970865|O2|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101253|NCT01970865|O1|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101254|NCT01970865|O4|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101255|NCT01970865|O3|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101256|NCT01970865|O2|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101257|NCT01970865|O1|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101258|NCT01970865|O6|Outcome|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101259|NCT01970865|O5|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101260|NCT01970865|O4|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101261|NCT01970865|O3|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101262|NCT01970865|O2|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101263|NCT01970865|O1|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101264|NCT01970865|O6|Outcome|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101265|NCT01970865|O5|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101266|NCT01970865|O4|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101267|NCT01970865|O3|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101268|NCT01970865|O2|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101269|NCT01970865|O1|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101270|NCT01970865|O6|Outcome|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101271|NCT01970865|O5|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101272|NCT01970865|O4|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101273|NCT01970865|O3|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101274|NCT01970865|O2|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101275|NCT01970865|O1|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101276|NCT01970865|O10|Outcome|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101277|NCT01970865|O9|Outcome|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101278|NCT01970865|O8|Outcome|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101279|NCT01970865|O7|Outcome|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101280|NCT01970865|O6|Outcome|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101436|NCT01970865|O1|Outcome|ALK Positive Population (Phase 1)|This reporting arm includes all Phase 1 participants who had documented ALK rearrangement.
101283|NCT01970865|O3|Outcome|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101284|NCT01970865|O2|Outcome|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101285|NCT01970865|O1|Outcome|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101286|NCT01970865|O1|Outcome|Phase 1 PRO Evaluable Population|This reporting group includes all Phase 1 participants who received at least 1 dose of PF-06463922 and completed a baseline and at least 1 post-baseline PRO assessment.
101287|NCT01970865|O1|Outcome|Phase 1 PRO Evaluable Population|This reporting group includes all Phase 1 participants who received at least 1 dose of PF-06463922 and completed a baseline and at least 1 post-baseline PRO assessment.
101288|NCT01970865|O1|Outcome|ALK Positive Population (Phase 1)|This reporting arm includes all Phase 1 participants who had documented ALK rearrangement.
101289|NCT01970865|O1|Outcome|ALK Positive Population (Phase 1)|This reporting arm includes all Phase 1 participants who had documented ALK rearrangement.
101290|NCT01970865|O2|Outcome|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101291|NCT01970865|O1|Outcome|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101292|NCT01970865|O2|Outcome|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101293|NCT01970865|O1|Outcome|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101294|NCT01970865|O2|Outcome|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101295|NCT01970865|O1|Outcome|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101296|NCT01970865|O2|Outcome|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101297|NCT01970865|O1|Outcome|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101298|NCT01970865|O2|Outcome|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101299|NCT01970865|O1|Outcome|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101300|NCT01970865|O2|Outcome|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101301|NCT01970865|O1|Outcome|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101302|NCT01970865|O2|Outcome|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101303|NCT01970865|O1|Outcome|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101304|NCT01970865|O1|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101305|NCT01970865|O1|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101306|NCT01970865|O8|Outcome|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101437|NCT01970865|O2|Outcome|ROS1 Positive Population (Phase 1)|This reporting arm includes all Phase 1 participants who had documented ROS1 rearrangement.
101307|NCT01970865|O7|Outcome|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101308|NCT01970865|O6|Outcome|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101309|NCT01970865|O5|Outcome|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101310|NCT01970865|O4|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101311|NCT01970865|O3|Outcome|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101312|NCT01970865|O2|Outcome|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101313|NCT01970865|O1|Outcome|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101314|NCT01970865|O8|Outcome|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101315|NCT01970865|O7|Outcome|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101316|NCT01970865|O6|Outcome|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101317|NCT01970865|O5|Outcome|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101318|NCT01970865|O4|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101319|NCT01970865|O3|Outcome|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101320|NCT01970865|O2|Outcome|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101321|NCT01970865|O1|Outcome|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101322|NCT01970865|O10|Outcome|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101323|NCT01970865|O9|Outcome|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101324|NCT01970865|O8|Outcome|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101325|NCT01970865|O7|Outcome|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101326|NCT01970865|O6|Outcome|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101327|NCT01970865|O5|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101328|NCT01970865|O4|Outcome|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101329|NCT01970865|O3|Outcome|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101330|NCT01970865|O2|Outcome|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101331|NCT01970865|O1|Outcome|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
102662|NCT01965561|E1|Reported Event|Junctional Tourniquet Use|Junctional tourniquet use followed by rest, repeat.
101332|NCT01970865|O8|Outcome|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101333|NCT01970865|O7|Outcome|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101334|NCT01970865|O6|Outcome|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101335|NCT01970865|O5|Outcome|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101336|NCT01970865|O4|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101337|NCT01970865|O3|Outcome|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101338|NCT01970865|O2|Outcome|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101339|NCT01970865|O1|Outcome|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101340|NCT01970865|O10|Outcome|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101341|NCT01970865|O9|Outcome|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101342|NCT01970865|O8|Outcome|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101343|NCT01970865|O7|Outcome|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101344|NCT01970865|O6|Outcome|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101345|NCT01970865|O5|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101346|NCT01970865|O4|Outcome|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101347|NCT01970865|O3|Outcome|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101348|NCT01970865|O2|Outcome|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101349|NCT01970865|O1|Outcome|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101350|NCT01970865|O8|Outcome|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101351|NCT01970865|O7|Outcome|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101352|NCT01970865|O6|Outcome|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101353|NCT01970865|O5|Outcome|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101354|NCT01970865|O4|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101355|NCT01970865|O3|Outcome|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101356|NCT01970865|O2|Outcome|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
102663|NCT01965535|B3|Baseline|Total|Total of all reporting groups
101357|NCT01970865|O1|Outcome|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101358|NCT01970865|O8|Outcome|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101359|NCT01970865|O7|Outcome|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101360|NCT01970865|O6|Outcome|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101361|NCT01970865|O5|Outcome|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101362|NCT01970865|O4|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101363|NCT01970865|O3|Outcome|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101364|NCT01970865|O2|Outcome|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101365|NCT01970865|O1|Outcome|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101366|NCT01970865|O10|Outcome|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101367|NCT01970865|O9|Outcome|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101368|NCT01970865|O8|Outcome|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101369|NCT01970865|O7|Outcome|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101370|NCT01970865|O6|Outcome|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101371|NCT01970865|O5|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101372|NCT01970865|O4|Outcome|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101373|NCT01970865|O3|Outcome|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101374|NCT01970865|O2|Outcome|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101375|NCT01970865|O1|Outcome|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101376|NCT01970865|O10|Outcome|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101377|NCT01970865|O9|Outcome|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101378|NCT01970865|O8|Outcome|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101379|NCT01970865|O7|Outcome|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101380|NCT01970865|O6|Outcome|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101381|NCT01970865|O5|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101382|NCT01970865|O4|Outcome|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101383|NCT01970865|O3|Outcome|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101384|NCT01970865|O2|Outcome|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101385|NCT01970865|O1|Outcome|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101386|NCT01970865|O10|Outcome|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101387|NCT01970865|O9|Outcome|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101388|NCT01970865|O8|Outcome|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101389|NCT01970865|O7|Outcome|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101390|NCT01970865|O6|Outcome|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101391|NCT01970865|O5|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101392|NCT01970865|O4|Outcome|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101393|NCT01970865|O3|Outcome|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101394|NCT01970865|O2|Outcome|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101395|NCT01970865|O1|Outcome|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101396|NCT01970865|O10|Outcome|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101397|NCT01970865|O9|Outcome|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101398|NCT01970865|O8|Outcome|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101399|NCT01970865|O7|Outcome|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101400|NCT01970865|O6|Outcome|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101401|NCT01970865|O5|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101402|NCT01970865|O4|Outcome|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101403|NCT01970865|O3|Outcome|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101404|NCT01970865|O2|Outcome|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101405|NCT01970865|O1|Outcome|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101406|NCT01970865|O10|Outcome|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101407|NCT01970865|O9|Outcome|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101408|NCT01970865|O8|Outcome|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101409|NCT01970865|O7|Outcome|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101410|NCT01970865|O6|Outcome|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101411|NCT01970865|O5|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101412|NCT01970865|O4|Outcome|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101413|NCT01970865|O3|Outcome|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101414|NCT01970865|O2|Outcome|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101415|NCT01970865|O1|Outcome|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101416|NCT01970865|O10|Outcome|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101417|NCT01970865|O9|Outcome|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101418|NCT01970865|O8|Outcome|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101419|NCT01970865|O7|Outcome|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101420|NCT01970865|O6|Outcome|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101421|NCT01970865|O5|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101422|NCT01970865|O4|Outcome|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101423|NCT01970865|O3|Outcome|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101424|NCT01970865|O2|Outcome|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101425|NCT01970865|O1|Outcome|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101426|NCT01970865|O2|Outcome|ROS1 Positive Population (Phase 1)|This reporting arm includes all Phase 1 participants who had documented ROS1 rearrangement.
101427|NCT01970865|O1|Outcome|ALK Positive Population (Phase 1)|This reporting arm includes all Phase 1 participants who had documented ALK rearrangement.
101428|NCT01970865|O2|Outcome|ROS1 Positive Population (Phase 1)|This reporting arm includes all Phase 1 participants who had documented ROS1 rearrangement.
101429|NCT01970865|O1|Outcome|ALK Positive Population (Phase 1)|This reporting arm includes all Phase 1 participants who had documented ALK rearrangement.
101430|NCT01970865|O1|Outcome|Phase 1 ITT Population|This reporting group includes all Phase 1 participants in the ITT analysis set.
101431|NCT01970865|O2|Outcome|ROS1 Positive Population (Phase 1)|This reporting arm includes all Phase 1 participants who had documented ROS1 rearrangement.
101432|NCT01970865|O1|Outcome|ALK Positive Population (Phase 1)|This reporting arm includes all Phase 1 participants who had documented ALK rearrangement.
101433|NCT01970865|O2|Outcome|ROS1 Positive Population (Phase 1)|This reporting arm includes all Phase 1 participants who had documented ROS1 rearrangement.
101434|NCT01970865|O1|Outcome|ALK Positive Population (Phase 1)|This reporting arm includes all Phase 1 participants who had documented ALK rearrangement.
101435|NCT01970865|O2|Outcome|ROS1 Positive Population (Phase 1)|This reporting arm includes all Phase 1 participants who had documented ROS1 rearrangement.
107181|NCT01946243|O2|Outcome|VisQ|Quantitation as an adjunct to qualitative scan interpretation
101439|NCT01970865|O6|Outcome|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101440|NCT01970865|O5|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101441|NCT01970865|O4|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101442|NCT01970865|O3|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101443|NCT01970865|O2|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101444|NCT01970865|O1|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101445|NCT01970865|O10|Outcome|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101446|NCT01970865|O9|Outcome|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101447|NCT01970865|O8|Outcome|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101448|NCT01970865|O7|Outcome|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101449|NCT01970865|O6|Outcome|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101450|NCT01970865|O5|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101451|NCT01970865|O4|Outcome|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101452|NCT01970865|O3|Outcome|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101453|NCT01970865|O2|Outcome|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101454|NCT01970865|O1|Outcome|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101455|NCT01970865|E17|Reported Event|Japan Lead-In Cohort (LIC)|Few Japanese participants were given PF-06463922 100 mg orally once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal to evaluate safety of PF-06463922 in Japanese participants, in order to support inclusion of Japanese participants in Phase 2.
101456|NCT01970865|E16|Reported Event|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101479|NCT01970787|E1|Reported Event|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
101480|NCT01970488|B3|Baseline|Total|Total of all reporting groups
101457|NCT01970865|E15|Reported Event|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101458|NCT01970865|E14|Reported Event|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101459|NCT01970865|E13|Reported Event|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101460|NCT01970865|E12|Reported Event|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101461|NCT01970865|E11|Reported Event|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101462|NCT01970865|E10|Reported Event|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101463|NCT01970865|E9|Reported Event|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101464|NCT01970865|E8|Reported Event|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101465|NCT01970865|E7|Reported Event|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101466|NCT01970865|E6|Reported Event|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101467|NCT01970865|E5|Reported Event|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101468|NCT01970865|E4|Reported Event|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101469|NCT01970865|E3|Reported Event|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101470|NCT01970865|E2|Reported Event|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
101471|NCT01970865|E1|Reported Event|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
101472|NCT01970787|B1|Baseline|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
101473|NCT01970787|P1|Participant Flow|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
101474|NCT01970787|O1|Outcome|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
101475|NCT01970787|O1|Outcome|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
101476|NCT01970787|O1|Outcome|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
101477|NCT01970787|O1|Outcome|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
101478|NCT01970787|O1|Outcome|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
101482|NCT01970488|B1|Baseline|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
101483|NCT01970488|P5|Participant Flow|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
101484|NCT01970488|P4|Participant Flow|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
101485|NCT01970488|P3|Participant Flow|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
101486|NCT01970488|P2|Participant Flow|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
101487|NCT01970488|P1|Participant Flow|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
101488|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
101489|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
101490|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
101491|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
101492|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
101493|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
101494|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
101495|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
101496|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
101497|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
101498|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
101499|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
101500|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
101501|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
101502|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
101503|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
101504|NCT01970488|O5|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
101505|NCT01970488|O4|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
101506|NCT01970488|O3|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
101507|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
101508|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
101509|NCT01970488|O5|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
101510|NCT01970488|O4|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
101511|NCT01970488|O3|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
101512|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
101513|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
101514|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
101515|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
101516|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
101517|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
101518|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
101519|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
101520|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
101521|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
101522|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
101523|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
101524|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
101525|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
101526|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
101527|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
101528|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
101529|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
101530|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
101531|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
101532|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
101533|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
101534|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
101535|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
101536|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
101537|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
101538|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
101539|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
101540|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
101541|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
101542|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
101543|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
101544|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
101545|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
101546|NCT01970488|E5|Reported Event|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
101547|NCT01970488|E4|Reported Event|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
101548|NCT01970488|E3|Reported Event|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
101549|NCT01970488|E2|Reported Event|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
101550|NCT01970488|E1|Reported Event|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
101551|NCT01970475|B3|Baseline|Total|Total of all reporting groups
101552|NCT01970475|B2|Baseline|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
101553|NCT01970475|B1|Baseline|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
101554|NCT01970475|P2|Participant Flow|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
101555|NCT01970475|P1|Participant Flow|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
101556|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
101557|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
101558|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
101559|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
101560|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
101561|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
101562|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
101563|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
101564|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
101565|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
101566|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
101567|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
101568|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
101569|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
101570|NCT01970475|E2|Reported Event|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
101571|NCT01970475|E1|Reported Event|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
101572|NCT01970462|B3|Baseline|Total|Total of all reporting groups
101573|NCT01970462|B2|Baseline|Placebo|"Patients will receive placebo prior to discharge and 6 weeks after discharge.~Placebo: Patients are reandomized to Sitagliptin or placebo for 6 weeks post-operatively"
101574|NCT01970462|B1|Baseline|Sitagliptin|"Patients will receive Sitagliptin (renally dosed) prior to hospital discharge and 6 weeks following discharge~Sitagliptin: Sitagliptin prior to hospital discharge and 6 weeks following discharge."
101575|NCT01970462|P2|Participant Flow|Placebo|"Patients will receive placebo prior to discharge and 6 weeks after discharge.~Placebo: Patients are reandomized to Sitagliptin or placebo for 6 weeks post-operatively"
101576|NCT01970462|P1|Participant Flow|Sitagliptin|"Patients will receive Sitagliptin (renally dosed) prior to hospital discharge and 6 weeks following discharge~Sitagliptin: Sitagliptin prior to hospital discharge and 6 weeks following discharge."
101577|NCT01970462|O2|Outcome|Placebo|"Patients will receive placebo prior to discharge and 6 weeks after discharge.~Placebo: Patients are reandomized to Sitagliptin or placebo for 6 weeks post-operatively"
101578|NCT01970462|O1|Outcome|Sitagliptin|"Patients will receive Sitagliptin (renally dosed) prior to hospital discharge and 6 weeks following discharge~Sitagliptin: Sitagliptin prior to hospital discharge and 6 weeks following discharge."
101579|NCT01970462|O2|Outcome|Placebo|"Patients will receive placebo prior to discharge and 6 weeks after discharge.~Placebo: Patients are reandomized to Sitagliptin or placebo for 6 weeks post-operatively"
101580|NCT01970462|O1|Outcome|Sitagliptin|"Patients will receive Sitagliptin (renally dosed) prior to hospital discharge and 6 weeks following discharge~Sitagliptin: Sitagliptin prior to hospital discharge and 6 weeks following discharge."
101581|NCT01970462|O2|Outcome|Placebo|"Patients will receive placebo prior to discharge and 6 weeks after discharge.~Placebo: Patients are reandomized to Sitagliptin or placebo for 6 weeks post-operatively"
101582|NCT01970462|O1|Outcome|Sitagliptin|"Patients will receive Sitagliptin (renally dosed) prior to hospital discharge and 6 weeks following discharge~Sitagliptin: Sitagliptin prior to hospital discharge and 6 weeks following discharge."
101583|NCT01970462|O2|Outcome|Placebo|"Patients will receive placebo prior to discharge and 6 weeks after discharge.~Placebo: Patients are reandomized to Sitagliptin or placebo for 6 weeks post-operatively"
101584|NCT01970462|O1|Outcome|Sitagliptin|"Patients will receive Sitagliptin (renally dosed) prior to hospital discharge and 6 weeks following discharge~Sitagliptin: Sitagliptin prior to hospital discharge and 6 weeks following discharge."
101585|NCT01970462|E2|Reported Event|Placebo|"Patients will receive placebo prior to discharge and 6 weeks after discharge.~Placebo: Patients are reandomized to Sitagliptin or placebo for 6 weeks post-operatively"
101586|NCT01970462|E1|Reported Event|Sitagliptin|"Patients will receive Sitagliptin (renally dosed) prior to hospital discharge and 6 weeks following discharge~Sitagliptin: Sitagliptin prior to hospital discharge and 6 weeks following discharge."
101587|NCT01970397|B3|Baseline|Total|Total of all reporting groups
101588|NCT01970397|B2|Baseline|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
101589|NCT01970397|B1|Baseline|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
101590|NCT01970397|P2|Participant Flow|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
101591|NCT01970397|P1|Participant Flow|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
101592|NCT01970397|O2|Outcome|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
101593|NCT01970397|O1|Outcome|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
101594|NCT01970397|O2|Outcome|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
101595|NCT01970397|O1|Outcome|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
101596|NCT01970397|O2|Outcome|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
101597|NCT01970397|O1|Outcome|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
101598|NCT01970397|E2|Reported Event|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
101599|NCT01970397|E1|Reported Event|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
101600|NCT01969799|B3|Baseline|Total|Total of all reporting groups
101601|NCT01969799|B2|Baseline|Aerosolized Placebo|"Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System~Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System"
101602|NCT01969799|B1|Baseline|Amikacin Fosfomycin Inhalation Solution|"300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.~Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System"
101603|NCT01969799|P2|Participant Flow|Aerosolized Placebo|"Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System~Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System"
101604|NCT01969799|P1|Participant Flow|Amikacin Fosfomycin Inhalation Solution|"300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.~Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System"
101605|NCT01969799|O2|Outcome|Aerosolized Placebo|"Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System~Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System"
101606|NCT01969799|O1|Outcome|Amikacin Fosfomycin Inhalation Solution|"300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.~Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System"
101607|NCT01969799|O2|Outcome|Aerosolized Placebo|"Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System~Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System"
101608|NCT01969799|O1|Outcome|Amikacin Fosfomycin Inhalation Solution|"300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.~Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System"
101609|NCT01969799|O2|Outcome|Aerosolized Placebo|"Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System~Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System"
101610|NCT01969799|O1|Outcome|Amikacin Fosfomycin Inhalation Solution|"300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.~Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System"
101611|NCT01969799|O2|Outcome|Aerosolized Placebo|"Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System~Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System"
101612|NCT01969799|O1|Outcome|Amikacin Fosfomycin Inhalation Solution|"300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.~Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System"
101613|NCT01969799|O2|Outcome|Aerosolized Placebo|"Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System~Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System"
101614|NCT01969799|O1|Outcome|Amikacin Fosfomycin Inhalation Solution|"300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.~Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System"
101615|NCT01969799|O2|Outcome|Aerosolized Placebo|"Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System~Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System"
101616|NCT01969799|O1|Outcome|Amikacin Fosfomycin Inhalation Solution|"300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.~Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System"
101617|NCT01969799|O2|Outcome|Aerosolized Placebo|"Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System~Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System"
101618|NCT01969799|O1|Outcome|Amikacin Fosfomycin Inhalation Solution|"300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.~Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System"
101619|NCT01969799|O2|Outcome|Aerosolized Placebo|"Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System~Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System"
101620|NCT01969799|O1|Outcome|Amikacin Fosfomycin Inhalation Solution|"300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.~Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System"
101621|NCT01969799|E2|Reported Event|Aerosolized Placebo|"Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System~Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System"
101622|NCT01969799|E1|Reported Event|Amikacin Fosfomycin Inhalation Solution|"300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.~Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System"
101623|NCT01969747|B5|Baseline|Total|Total of all reporting groups
101624|NCT01969747|B4|Baseline|Empagliflozin 25 mg|Empagliflozin 25 mg tablet; oral administration once daily
101625|NCT01969747|B3|Baseline|Empagliflozin 10 mg|Empagliflozin 10 mg tablet; oral administration once daily
101626|NCT01969747|B2|Baseline|Empagliflozin 2.5 mg|Empagliflozin 2.5 mg tablet; oral administration once daily
101627|NCT01969747|B1|Baseline|Placebo|Placebo tablet; oral administration once daily
101628|NCT01969747|P4|Participant Flow|Empagliflozin 25 mg|Empagliflozin 25 mg tablet; oral administration once daily
101629|NCT01969747|P3|Participant Flow|Empagliflozin 10 mg|Empagliflozin 10 mg tablet; oral administration once daily
101630|NCT01969747|P2|Participant Flow|Empagliflozin 2.5 mg|Empagliflozin 2.5 mg tablet; oral administration once daily
101631|NCT01969747|P1|Participant Flow|Placebo|Placebo tablet; oral administration once daily
101632|NCT01969747|O4|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg tablet; oral administration once daily
101633|NCT01969747|O3|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg tablet; oral administration once daily
101634|NCT01969747|O2|Outcome|Empagliflozin 2.5 mg|Empagliflozin 2.5 mg tablet; oral administration once daily
101635|NCT01969747|O1|Outcome|Placebo|Placebo tablet; oral administration once daily
101636|NCT01969747|E4|Reported Event|Empagliflozin 25 mg|Empagliflozin 25 mg tablet; oral administration once daily
101637|NCT01969747|E3|Reported Event|Empagliflozin 10 mg|Empagliflozin 10 mg tablet; oral administration once daily
101638|NCT01969747|E2|Reported Event|Empagliflozin 2.5 mg|Empagliflozin 2.5 mg tablet; oral administration once daily
101639|NCT01969747|E1|Reported Event|Placebo|Placebo tablet; oral administration once daily
101640|NCT01969721|B1|Baseline|Overall Study|"Patients received a total of four treatments. Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days. The treatments were orally inhaled.~Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Tiotropium+Olodaterol FDC inhalation solutions were administered via the Respimat® inhaler once daily, Fluticasone propionate+Salmeterol FDC inhalation powders were administered orally twice daily via Accuhaler®."
101641|NCT01969721|P4|Participant Flow|F+S 500/50 / F+S 250/50 / T+O 5/5 / T+O 2.5/5|"Patients received a total of four treatments. Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days. The treatments were orally inhaled.~Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Tiotropium+Olodaterol FDC inhalation solutions were administered via the Respimat® inhaler once daily, Fluticasone propionate+Salmeterol FDC inhalation powders were administered orally twice daily via Accuhaler®."
101642|NCT01969721|P3|Participant Flow|F+S 250/50 / T+O 2.5/5 / F+S 500/50 / T+O 5/5|"Patients received a total of four treatments. Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days. The treatments were orally inhaled.~Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Tiotropium+Olodaterol FDC inhalation solutions were administered via the Respimat® inhaler once daily, Fluticasone propionate+Salmeterol FDC inhalation powders were administered orally twice daily via Accuhaler®."
101643|NCT01969721|P2|Participant Flow|T+O 5/5 / F+S 500/50 / T+O 2.5/5 / F+S 250/50|"Patients received a total of four treatments. Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days. The treatments were orally inhaled.~Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Tiotropium+Olodaterol FDC inhalation solutions were administered via the Respimat® inhaler once daily, Fluticasone propionate+Salmeterol FDC inhalation powders were administered orally twice daily via Accuhaler®."
101644|NCT01969721|P1|Participant Flow|T+O 2.5/5 / T+O 5/5 / F+S 250/50 / F+S 500/50|"Patients received a total of four treatments. Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days. The treatments were orally inhaled .~Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo (T+O 2.5/5).~Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo (T+O 5/5).~Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo (F+S 250/50).~Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo (F+S 500/50).~Tiotropium+Olodaterol FDC inhalation solutions were administered via the Respimat® inhaler once daily, Fluticasone propionate+Salmeterol FDC inhalation powders were administered orally twice daily via Accuhaler®."
101645|NCT01969721|O4|Outcome|F+S 500/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg (F+S 500/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
101646|NCT01969721|O3|Outcome|F+S 250/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg (F+S 250/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
101647|NCT01969721|O2|Outcome|T+O 5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg (T+O 5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
101648|NCT01969721|O1|Outcome|T+O 2.5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (T+O 2.5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
101649|NCT01969721|O4|Outcome|F+S 500/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg (F+S 500/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
101650|NCT01969721|O3|Outcome|F+S 250/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg (F+S 250/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
101651|NCT01969721|O2|Outcome|T+O 5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg (T+O 5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
101652|NCT01969721|O1|Outcome|T+O 2.5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (T+O 2.5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
101653|NCT01969721|O4|Outcome|F+S 500/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg (F+S 500/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
101654|NCT01969721|O3|Outcome|F+S 250/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg (F+S 250/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
101655|NCT01969721|O2|Outcome|T+O 5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg (T+O 5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
101656|NCT01969721|O1|Outcome|T+O 2.5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (T+O 2.5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
101657|NCT01969721|O4|Outcome|F+S 500/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg (F+S 500/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
101658|NCT01969721|O3|Outcome|F+S 250/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg (F+S 250/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
101659|NCT01969721|O2|Outcome|T+O 5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg (T+O 5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
102253|NCT01966770|O4|Outcome|BF SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
101660|NCT01969721|O1|Outcome|T+O 2.5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (T+O 2.5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
101661|NCT01969721|O4|Outcome|F+S 500/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg (F+S 500/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
101662|NCT01969721|O3|Outcome|F+S 250/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg (F+S 250/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
101663|NCT01969721|O2|Outcome|T+O 5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg (T+O 5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
101664|NCT01969721|O1|Outcome|T+O 2.5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (T+O 2.5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
101665|NCT01969721|E4|Reported Event|F+S 500/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg (F+S 500/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
101666|NCT01969721|E3|Reported Event|F+S 250/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg (F+S 250/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
101667|NCT01969721|E2|Reported Event|T+O 5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg (T+O 5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
101668|NCT01969721|E1|Reported Event|T+O 2.5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (T+O 2.5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
101669|NCT01969565|B1|Baseline|Carfilzomib in Combination With Dexamethasone|Carfilzomib will be administered at a dose of 20 mg/m², with a dose escalation to 36 mg/m² after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m², with a dose escalation to 45 mg/m² after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.
101670|NCT01969565|P1|Participant Flow|Carfilzomib in Combination With Dexamethasone|Carfilzomib will be administered at a dose of 20 mg/m², with a dose escalation to 36 mg/m² after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m², with a dose escalation to 45 mg/m² after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.
101671|NCT01969565|O1|Outcome|Carfilzomib in Combination With Dexamethasone|Carfilzomib will be administered at a dose of 20 mg/m², with a dose escalation to 36 mg/m² after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m², with a dose escalation to 45 mg/m² after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.
101672|NCT01969565|O1|Outcome|Carfilzomib in Combination With Dexamethasone|Carfilzomib will be administered at a dose of 20 mg/m², with a dose escalation to 36 mg/m² after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m², with a dose escalation to 45 mg/m² after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.
101673|NCT01969565|O1|Outcome|Carfilzomib in Combination With Dexamethasone|"Carfilzomib will be administered at a dose of 20 mg/m2, with a dose escalation to 36 mg/m2 after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m2, with a dose escalation to 45 mg/m2 after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.~Carfilzomib~Dexamethasone"
101674|NCT01969565|E1|Reported Event|Carfilzomib in Combination With Dexamethasone|Carfilzomib will be administered at a dose of 20 mg/m², with a dose escalation to 36 mg/m² after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m², with a dose escalation to 45 mg/m² after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.
101675|NCT01969539|B1|Baseline|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
102254|NCT01966770|O3|Outcome|F55 SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
101676|NCT01969539|P1|Participant Flow|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
101677|NCT01969539|O1|Outcome|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
101678|NCT01969539|O1|Outcome|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
101679|NCT01969539|O1|Outcome|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
101680|NCT01969539|E1|Reported Event|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
101681|NCT01969448|B4|Baseline|Total|Total of all reporting groups
101682|NCT01969448|B3|Baseline|Non-Randomized Cohort|"Patients in which the surgeon feels that for oncologic reasons must have a specific incision (either inframammary fold or lateral radial incision) and cannot be randomized due to concerns of compromising clinical care but otherwise meet the inclusion and exclusion criteria will be offered participation as part of a non-randomized cohort.~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101683|NCT01969448|B2|Baseline|Lateral Radial Incision Cohort|"Lateral radial incision~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101684|NCT01969448|B1|Baseline|Inframammary Fold Incision Cohort|"Inframammary fold incision which is in the crease under the breast.~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101685|NCT01969448|P3|Participant Flow|Non-Randomized Cohort|"Patients in which the surgeon feels that for oncologic reasons must have a specific incision (either inframammary fold or lateral radial incision) and cannot be randomized due to concerns of compromising clinical care but otherwise meet the inclusion and exclusion criteria will be offered participation as part of a non-randomized cohort.~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101686|NCT01969448|P2|Participant Flow|Lateral Radial Incision Cohort|"Lateral radial incision~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101687|NCT01969448|P1|Participant Flow|Inframammary Fold Incision Cohort|"Inframammary fold incision which is in the crease under the breast.~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101688|NCT01969448|O3|Outcome|Non-Randomized Cohort|"Patients in which the surgeon feels that for oncologic reasons must have a specific incision (either inframammary fold or lateral radial incision) and cannot be randomized due to concerns of compromising clinical care but otherwise meet the inclusion and exclusion criteria will be offered participation as part of a non-randomized cohort.~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101689|NCT01969448|O2|Outcome|Lateral Radial Incision Cohort|"Lateral radial incision~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101690|NCT01969448|O1|Outcome|Inframammary Fold Incision Cohort|"Inframammary fold incision which is in the crease under the breast.~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101691|NCT01969448|O3|Outcome|Non-Randomized Cohort|"Patients in which the surgeon feels that for oncologic reasons must have a specific incision (either inframammary fold or lateral radial incision) and cannot be randomized due to concerns of compromising clinical care but otherwise meet the inclusion and exclusion criteria will be offered participation as part of a non-randomized cohort.~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101692|NCT01969448|O2|Outcome|Lateral Radial Incision Cohort|"Lateral radial incision~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101693|NCT01969448|O1|Outcome|Inframammary Fold Incision Cohort|"Inframammary fold incision which is in the crease under the breast.~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101694|NCT01969448|O3|Outcome|Non-Randomized Cohort|"Patients in which the surgeon feels that for oncologic reasons must have a specific incision (either inframammary fold or lateral radial incision) and cannot be randomized due to concerns of compromising clinical care but otherwise meet the inclusion and exclusion criteria will be offered participation as part of a non-randomized cohort.~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101695|NCT01969448|O2|Outcome|Lateral Radial Incision Cohort|"Lateral radial incision~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101696|NCT01969448|O1|Outcome|Inframammary Fold Incision Cohort|"Inframammary fold incision which is in the crease under the breast.~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101697|NCT01969448|O3|Outcome|Non-Randomized Cohort|"Patients in which the surgeon feels that for oncologic reasons must have a specific incision (either inframammary fold or lateral radial incision) and cannot be randomized due to concerns of compromising clinical care but otherwise meet the inclusion and exclusion criteria will be offered participation as part of a non-randomized cohort.~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101698|NCT01969448|O2|Outcome|Lateral Radial Incision Cohort|"Lateral radial incision~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101699|NCT01969448|O1|Outcome|Inframammary Fold Incision Cohort|"Inframammary fold incision which is in the crease under the breast.~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101712|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
107182|NCT01946243|O1|Outcome|Qualitative|Qualitative scan interpretation only
101700|NCT01969448|O3|Outcome|Non-Randomized Cohort|"Patients in which the surgeon feels that for oncologic reasons must have a specific incision (either inframammary fold or lateral radial incision) and cannot be randomized due to concerns of compromising clinical care but otherwise meet the inclusion and exclusion criteria will be offered participation as part of a non-randomized cohort.~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101701|NCT01969448|O2|Outcome|Lateral Radial Incision Cohort|"Lateral radial incision~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101702|NCT01969448|O1|Outcome|Inframammary Fold Incision Cohort|"Inframammary fold incision which is in the crease under the breast.~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101703|NCT01969448|O3|Outcome|Non-Randomized Cohort|"Patients in which the surgeon feels that for oncologic reasons must have a specific incision (either inframammary fold or lateral radial incision) and cannot be randomized due to concerns of compromising clinical care but otherwise meet the inclusion and exclusion criteria will be offered participation as part of a non-randomized cohort.~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101704|NCT01969448|O2|Outcome|Lateral Radial Incision Cohort|"Lateral radial incision~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101705|NCT01969448|O1|Outcome|Inframammary Fold Incision Cohort|"Inframammary fold incision which is in the crease under the breast.~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101706|NCT01969448|E3|Reported Event|Non-Randomized Cohort|"Patients in which the surgeon feels that for oncologic reasons must have a specific incision (either inframammary fold or lateral radial incision) and cannot be randomized due to concerns of compromising clinical care but otherwise meet the inclusion and exclusion criteria will be offered participation as part of a non-randomized cohort.~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101707|NCT01969448|E2|Reported Event|Lateral Radial Incision Cohort|"Lateral radial incision~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101708|NCT01969448|E1|Reported Event|Inframammary Fold Incision Cohort|"Inframammary fold incision which is in the crease under the breast.~Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)~Intraoperatively prior to mastectomy~At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) – (ie. Mastectomy done, implant not in yet)~Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)"
101709|NCT01969435|B1|Baseline|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
101710|NCT01969435|P1|Participant Flow|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
101711|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
104114|NCT01958671|O2|Outcome|Ertugliflozin 15 mg|Participants received ertugliflozin 15 mg once daily for 26 weeks
101713|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
101714|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
101715|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
101716|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
101717|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
101718|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
101719|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
101720|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
101721|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
101722|NCT01969435|E1|Reported Event|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
101723|NCT01969162|B1|Baseline|All Participants|Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.
101724|NCT01969162|P1|Participant Flow|All Participants|Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.
101725|NCT01969162|O1|Outcome|All Participants|Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.
101726|NCT01969162|E1|Reported Event|All Participants|Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.
101727|NCT01969084|B3|Baseline|Total|Total of all reporting groups
101728|NCT01969084|B2|Baseline|Sugar Pill|"Subjects given sugar pill/placebo~Placebo~Microcirculation testing: The endothelial function of the micro-circulation was assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity.Visible and NIR Medical Hyperspectral Imaging (MHSI) data will be collected with a HyperMed OxyView MHSI System (HyperMed, Inc., Watertown, MA). MHSI images will be obtained from same forearm area where the iontophoresis of acetylcholine and sodium nitroprusside will be performed, before and after the iontophoresis test.~Macrocirculation testing: Use ultrasound to measure brachial artery flow mediated vasodilation (FMD, endothelium-dependent vasodilation) and nitroglycerin induced dilation (NID, endothelium-independent vasod"
101729|NCT01969084|B1|Baseline|Linagliptin|"Subjects given Linagliptin~Linagliptin~Microcirculation testing: The endothelial function of the micro-circulation was assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity.Visible and NIR Medical Hyperspectral Imaging (MHSI) data will be collected with a HyperMed OxyView MHSI System (HyperMed, Inc., Watertown, MA). MHSI images will be obtained from same forearm area where the iontophoresis of acetylcholine and sodium nitroprusside will be performed, before and after the iontophoresis test.~Macrocirculation testing: Use ultrasound to measure brachial artery flow mediated vasodilation (FMD, endothelium-dependent vasodilation) and nitroglycerin induced dilation (NID, endothelium-independent vasodila"
101730|NCT01969084|P2|Participant Flow|Sugar Pill|"Subjects given sugar pill/placebo~Placebo~Microcirculation testing: The endothelial function of the micro-circulation was assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity.Visible and NIR Medical Hyperspectral Imaging (MHSI) data will be collected with a HyperMed OxyView MHSI System (HyperMed, Inc., Watertown, MA). MHSI images will be obtained from same forearm area where the iontophoresis of acetylcholine and sodium nitroprusside will be performed, before and after the iontophoresis test.~Macrocirculation testing: Use ultrasound to measure brachial artery flow mediated vasodilation (FMD, endothelium-dependent vasodilation) and nitroglycerin induced dilation (NID, endothelium-independent vasod"
101770|NCT01969058|O1|Outcome|Isotretinoin Arm|Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.
101771|NCT01969058|O2|Outcome|No Study Treatment Arm|No Isotretinoin treatment
101772|NCT01969058|O1|Outcome|Isotretinoin Arm|Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.
101773|NCT01969058|O2|Outcome|No Study Treatment Arm|No Isotretinoin treatment
101731|NCT01969084|P1|Participant Flow|Linagliptin|"Subjects given Linagliptin~Linagliptin~Microcirculation testing: The endothelial function of the micro-circulation was assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity.Visible and NIR Medical Hyperspectral Imaging (MHSI) data will be collected with a HyperMed OxyView MHSI System (HyperMed, Inc., Watertown, MA). MHSI images will be obtained from same forearm area where the iontophoresis of acetylcholine and sodium nitroprusside will be performed, before and after the iontophoresis test.~Macrocirculation testing: Use ultrasound to measure brachial artery flow mediated vasodilation (FMD, endothelium-dependent vasodilation) and nitroglycerin induced dilation (NID, endothelium-independent vasodila"
101732|NCT01969084|O2|Outcome|Sugar Pill|Subjects given sugar pill/placebo
101733|NCT01969084|O1|Outcome|Linagliptin|Subjects given Linagliptin
101734|NCT01969084|O2|Outcome|Sugar Pill|Subjects given sugar pill/placebo
101735|NCT01969084|O1|Outcome|Linagliptin|Subjects given Linagliptin
101736|NCT01969084|O2|Outcome|Sugar Pill|"Subjects given sugar pill/placebo~Placebo~Microcirculation testing: The endothelial function of the micro-circulation was assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity"
101737|NCT01969084|O1|Outcome|Linagliptin|Linagliptin treated group
101738|NCT01969084|O2|Outcome|Sugar Pill|"Subjects given sugar pill/placebo~Placebo~MRI Scans: Phosphorus-31 MRI data was obtained during an exercise protocol. Muscle oxygenation will be measured using the blood oxygenation level-dependent magnetic resonance imaging (BOLD MRI) technique after induced hyperemia."
101739|NCT01969084|O1|Outcome|Linagliptin|"Subjects given Linagliptin~Linagliptin~MRI Scans: Phosphorus-31 MRI data was obtained during an exercise protocol. Muscle oxygenation will be measured using the blood oxygenation level-dependent magnetic resonance imaging (BOLD MRI) technique after induced hyperemia."
101740|NCT01969084|O2|Outcome|Sugar Pill|"Subjects given sugar pill/placebo~Placebo~MRI Scans: Phosphorus-31 MRI data was obtained during an exercise protocol. Muscle oxygenation will be measured using the blood oxygenation level-dependent magnetic resonance imaging (BOLD MRI) technique after induced hyperemia."
101741|NCT01969084|O1|Outcome|Linagliptin|"Subjects given Linagliptin~Linagliptin~MRI Scans: Phosphorus-31 MRI data was obtained during an exercise protocol. Muscle oxygenation will be measured using the blood oxygenation level-dependent magnetic resonance imaging (BOLD MRI) technique after induced hyperemia."
101742|NCT01969084|E2|Reported Event|Sugar Pill|"Subjects given sugar pill/placebo~Placebo"
101743|NCT01969084|E1|Reported Event|Linagliptin|Subjects given Linagliptin
101744|NCT01969058|B3|Baseline|Total|Total of all reporting groups
101745|NCT01969058|B2|Baseline|No Study Treatment Arm|No Isotretinoin treatment
101746|NCT01969058|B1|Baseline|Isotretinoin Arm|Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.
101747|NCT01969058|P2|Participant Flow|No Study Treatment Arm|No Isotretinoin treatment
101748|NCT01969058|P1|Participant Flow|Isotretinoin Arm|Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.
101749|NCT01969058|O2|Outcome|No Study Treatment Arm|No Isotretinoin treatment
101750|NCT01969058|O1|Outcome|Isotretinoin Arm|Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.
101751|NCT01969058|O2|Outcome|No Study Treatment Arm|No Isotretinoin treatment
101752|NCT01969058|O1|Outcome|Isotretinoin Arm|Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.
101753|NCT01969058|O2|Outcome|No Study Treatment Arm|No Isotretinoin treatment
101754|NCT01969058|O1|Outcome|Isotretinoin Arm|Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.
101755|NCT01969058|O2|Outcome|No Study Treatment Arm|No Isotretinoin treatment
101756|NCT01969058|O1|Outcome|Isotretinoin Arm|Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.
101757|NCT01969058|O2|Outcome|No Study Treatment Arm|No Isotretinoin treatment
101758|NCT01969058|O1|Outcome|Isotretinoin Arm|Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.
101759|NCT01969058|O2|Outcome|No Study Treatment Arm|No Isotretinoin treatment
101760|NCT01969058|O1|Outcome|Isotretinoin Arm|Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.
101761|NCT01969058|O2|Outcome|No Study Treatment Arm|No Isotretinoin treatment
101762|NCT01969058|O1|Outcome|Isotretinoin Arm|Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.
101763|NCT01969058|O2|Outcome|No Study Treatment Arm|No Isotretinoin treatment
101764|NCT01969058|O1|Outcome|Isotretinoin Arm|Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.
101765|NCT01969058|O2|Outcome|No Study Treatment Arm|No Isotretinoin treatment
101766|NCT01969058|O1|Outcome|Isotretinoin Arm|Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.
101767|NCT01969058|O2|Outcome|No Study Treatment Arm|No Isotretinoin treatment
101768|NCT01969058|O1|Outcome|Isotretinoin Arm|Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.
101769|NCT01969058|O2|Outcome|No Study Treatment Arm|No Isotretinoin treatment
101774|NCT01969058|O1|Outcome|Isotretinoin Arm|Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.
101775|NCT01969058|O2|Outcome|No Study Treatment Arm|No Isotretinoin treatment
101776|NCT01969058|O1|Outcome|Isotretinoin Arm|Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.
101777|NCT01969058|O2|Outcome|No Study Treatment Arm|No Isotretinoin treatment
101778|NCT01969058|O1|Outcome|Isotretinoin Arm|Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.
101779|NCT01969058|E2|Reported Event|No Study Treatment|No Isotretinoin treatment
101780|NCT01969058|E1|Reported Event|Isotretinoin|Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.
101781|NCT01968980|B3|Baseline|Total|Total of all reporting groups
101782|NCT01968980|B2|Baseline|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101783|NCT01968980|B1|Baseline|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101784|NCT01968980|P2|Participant Flow|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101785|NCT01968980|P1|Participant Flow|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101786|NCT01968980|O1|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101787|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101788|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101789|NCT01968980|O1|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101790|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101791|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101792|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101793|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101794|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101795|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101796|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101797|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101798|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101799|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101800|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101801|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101802|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101803|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101804|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101805|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101806|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101807|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101808|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101809|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101810|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101811|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101812|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101813|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101814|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101815|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101816|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101817|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101818|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101819|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101820|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101821|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101822|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101823|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101824|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101825|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101826|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101827|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101828|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101829|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101830|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101831|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101832|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101833|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101834|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101835|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101836|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101837|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101838|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101839|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101840|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101841|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101842|NCT01968980|E2|Reported Event|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101973|NCT01968811|B1|Baseline|Avance Foam, Abdominal Dressing Kit|Avance Foam dressing kit
107183|NCT01946243|O3|Outcome|Change|Change = VisQ - Qualitative
101843|NCT01968980|E1|Reported Event|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101844|NCT01968967|B3|Baseline|Total|Total of all reporting groups
101845|NCT01968967|B2|Baseline|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101846|NCT01968967|B1|Baseline|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101847|NCT01968967|P2|Participant Flow|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101848|NCT01968967|P1|Participant Flow|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101849|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101850|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101851|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101852|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101853|NCT01968967|O1|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101854|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101855|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101856|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101857|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101858|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101859|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101860|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101861|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101862|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101863|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101864|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101865|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101866|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101867|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101868|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101869|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101870|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101871|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101872|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101873|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101874|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101875|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101974|NCT01968811|P1|Participant Flow|Avance Foam, Abdominal Dressing Kit|Avance Foam dressing kit
101876|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101877|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101878|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101879|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101880|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101881|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101882|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101883|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101884|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101885|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101886|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101887|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101888|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101889|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101890|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101891|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101892|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101893|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101894|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101895|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101896|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101897|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101898|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101899|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101900|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101901|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101902|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101903|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101904|NCT01968967|E2|Reported Event|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101905|NCT01968967|E1|Reported Event|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
101906|NCT01968954|B3|Baseline|Total|Total of all reporting groups
101907|NCT01968954|B2|Baseline|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101908|NCT01968954|B1|Baseline|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101975|NCT01968811|O1|Outcome|Avance Foam, Abdominal Dressing Kit|Avance Foam dressing kit
101976|NCT01968811|O1|Outcome|Avance Foam, Abdominal Dressing Kit|Avance Foam dressing kit
101909|NCT01968954|P2|Participant Flow|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101910|NCT01968954|P1|Participant Flow|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101911|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101912|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101913|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101914|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101915|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101916|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101917|NCT01968954|O1|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101918|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101919|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101920|NCT01968954|O1|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101921|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101922|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101923|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101924|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101925|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101926|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101927|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101928|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101929|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101930|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101931|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101932|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101933|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101934|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101935|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101936|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101937|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101938|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101939|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101940|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101941|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101942|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101943|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101944|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101945|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101946|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101947|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101948|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101949|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101950|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101951|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101952|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101953|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101954|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101955|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101956|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101957|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101958|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101959|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101960|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101961|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101962|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101963|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101964|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101965|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101966|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101967|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101968|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101969|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101970|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101971|NCT01968954|E2|Reported Event|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101972|NCT01968954|E1|Reported Event|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
101979|NCT01968694|B2|Baseline|IV Diphenhydramine Then IV Lidocaine|"IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes.~IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes."
101980|NCT01968694|B1|Baseline|IV Lidocaine Then IV Diphenhydramine|"IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes.~IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes."
101981|NCT01968694|P2|Participant Flow|IV Diphenhydramine Then IV Lidocaine|"IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes.~IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes."
101982|NCT01968694|P1|Participant Flow|IV Lidocaine Then IV Diphenhydramine|"IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes.~IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes."
101983|NCT01968694|O2|Outcome|IV Diphenhydramine|IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
101984|NCT01968694|O1|Outcome|IV Lidocaine|IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
101985|NCT01968694|O2|Outcome|IV Diphenhydramine|IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
101986|NCT01968694|O1|Outcome|IV Lidocaine|IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
101987|NCT01968694|O2|Outcome|IV Diphenhydramine|IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
101988|NCT01968694|O1|Outcome|IV Lidocaine|IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
101989|NCT01968694|O2|Outcome|IV Diphenhydramine|IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
101990|NCT01968694|O1|Outcome|IV Lidocaine|IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
101991|NCT01968694|E4|Reported Event|Washout Period After IV Diphenhydramine|Washout period after IV diphenhydramine before IV Lidocaine
101992|NCT01968694|E3|Reported Event|Washout Period After IV Lidocaine|Washout period after IV Lidocaine before IV diphenhydramine
101993|NCT01968694|E2|Reported Event|IV Diphenhydramine|IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
101994|NCT01968694|E1|Reported Event|IV Lidocaine|IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
101995|NCT01968551|B4|Baseline|Total|Total of all reporting groups
101996|NCT01968551|B3|Baseline|Cohort 2: SBR|"Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
101997|NCT01968551|B2|Baseline|Cohort 2: E/C/F/TAF+DRV|"Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
101998|NCT01968551|B1|Baseline|Cohort 1: E/C/F/TAF+DRV|"Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
101999|NCT01968551|P3|Participant Flow|Cohort 2: Stay on Baseline Regimen (SBR)|"Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
102000|NCT01968551|P2|Participant Flow|Cohort 2: E/C/F/TAF+DRV|"Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for up to 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
102001|NCT01968551|P1|Participant Flow|Cohort 1: E/C/F/TAF+DRV|"Open-Label (OL) Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus Darunavir (DRV) (800 mg) tablet administered orally once daily for up to 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus Darunavir (DRV) (800 mg) tablet administered orally once daily"
102002|NCT01968551|O2|Outcome|Cohort 2: Stay on Baseline Regimen (SBR)|"Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.~Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
102003|NCT01968551|O1|Outcome|Cohort 2: E/C/F/TAF+DRV|"Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800mg) tablet administered orally once daily for up to 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
102004|NCT01968551|O2|Outcome|Cohort 2: Stay on Baseline Regimen (SBR)|"Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
102005|NCT01968551|O1|Outcome|Cohort 2: E/C/F/TAF+DRV|"Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for up to 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
102006|NCT01968551|O2|Outcome|Cohort 2: Stay on Baseline Regimen (SBR)|"Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
102007|NCT01968551|O1|Outcome|Cohort 2: E/C/F/TAF+DRV|"Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for up to 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
102008|NCT01968551|O2|Outcome|Cohort 2: Stay on Baseline Regimen (SBR)|"Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
107184|NCT01946243|O2|Outcome|VisQ|Quantitation as an adjunct to qualitative scan interpretation
102009|NCT01968551|O1|Outcome|Cohort 2: E/C/F/TAF+DRV|"Open-Label Phase: E/C/F/TDF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for up to 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
102010|NCT01968551|E4|Reported Event|All E/C/F/TAF|Open- label or Extension Phase: All participants received E/C/F/TAF.
102011|NCT01968551|E3|Reported Event|Cohort 2: SBR|"Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
102012|NCT01968551|E2|Reported Event|Cohort 2: E/C/F/TAF+DRV|"Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
102013|NCT01968551|E1|Reported Event|Cohort 1: E/C/F/TAF+DRV|"Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
102014|NCT01968434|B3|Baseline|Total|Total of all reporting groups
102015|NCT01968434|B2|Baseline|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)~carbocisteine cough syrup: Mucolytic~Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated carbocisteine syrup n = 72 received intervention n= 72 Lost to follow up n=6 Discontinued intervention n=0 Analyzed n=66 Excluded from analysis n=0"
102016|NCT01968434|B1|Baseline|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum in a syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.~Dosage: 6.5 ml three times a day for the duration of the study (4 nights, 3 days)~protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration.~Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated protective syrup n = 78 received intervention n= 78 Lost to follow up n=3 Discontinued intervention n=0 Analyzed n=75 Excluded from analysis n=0"
102017|NCT01968434|P2|Participant Flow|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)~carbocisteine cough syrup: Mucolytic~Access for eligibility= 195 Excluded =45 (refused to participate n= 24, not meeting inclusion criteria n=21) Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated carbocisteine syrup n = 72 received intervention n= 72 Lost to follow up n=6 Discontinued intervention n=0 Analyzed n=66 Excluded from analysis n=0"
102018|NCT01968434|P1|Participant Flow|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.~Dosage: 6,5 ml three times a day for the duration of the study (4 nights, 3 days)~protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration.~Access for eligibility= 195 Excluded =45 (refused to participate n= 24, not meeting inclusion criteria n=21) Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated protective syrup n = 78 received intervention n= 78 Lost to follow up n=3 Discontinued intervention n=0 Analyzed n=75 Excluded from analysis n=0"
102019|NCT01968434|O2|Outcome|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)~carbocisteine cough syrup: Mucolytic"
102020|NCT01968434|O1|Outcome|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.~Dosage: 20 ml divided in three doses per day for the duration of the study (4 nights, 3 days)~protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration."
102021|NCT01968434|O2|Outcome|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)~carbocisteine cough syrup: Mucolytic"
102022|NCT01968434|O1|Outcome|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.~Dosage: 20 ml divided in three doses per day for the duration of the study (4 nights, 3 days)~protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration."
102023|NCT01968434|O2|Outcome|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)~carbocisteine cough syrup: Mucolytic"
102024|NCT01968434|O1|Outcome|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.~Dosage: 20 ml divided in three doses per day for the duration of the study (4 nights, 3 days)~protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration."
102025|NCT01968434|E2|Reported Event|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)~carbocisteine cough syrup: Mucolytic"
102026|NCT01968434|E1|Reported Event|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.~Dosage: 6,5 ml three times a day for the duration of the study (4 nights, 3 days)~protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration."
102061|NCT01967940|P2|Participant Flow|Part 1 Randomized Cohort TAF, Then Part 2 E/C/F/TAF+ATV|"Part 1: TAF 25 mg tablet once daily + their current failing regimen for 10 days~Part 2: Following a 14-day washout period, participants who had a > 0.5 log10 decline in HIV-1 RNA received E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks."
102027|NCT01968226|B1|Baseline|PET Imaging With [F-18] RDG-K5|"This is an observational study of a group of individuals who all have carotid artery stenosis. The observation will be the measurement of [F-18]RGD-K5 uptake by the carotid artery plaque after intravenous administration of this radiolabeled tracer using PET imaging.~[F-18] RDG-K5: Up to fifteen (15) subjects with carotid stenosis >50% who are undergoing planned carotid endarterectomy will be imaged under PET with [F-18] RDG-K5"
102028|NCT01968226|P1|Participant Flow|PET Imaging With [F-18] RDG-K5|"This is an observational study of a group of individuals who all have carotid artery stenosis. The observation will be the measurement of [F-18]RGD-K5 uptake by the carotid artery plaque after intravenous administration of this radiolabeled tracer using PET imaging.~[F-18] RDG-K5: Up to fifteen (15) subjects with carotid stenosis >50% who are undergoing planned carotid endarterectomy will be imaged under PET with [F-18] RDG-K5"
102029|NCT01968226|O1|Outcome|PET Imaging With [F-18] RDG-K5|"This is an observational study of a group of individuals who all have carotid artery stenosis. The observation will be the measurement of [F-18]RGD-K5 uptake by the carotid artery plaque after intravenous administration of this radiolabeled tracer using PET imaging.~[F-18] RDG-K5: Up to fifteen (15) subjects with carotid stenosis >50% who are undergoing planned carotid endarterectomy will be imaged under PET with [F-18] RDG-K5"
102030|NCT01968226|E1|Reported Event|PET Imaging With [F-18] RDG-K5|"This is an observational study of a group of individuals who all have carotid artery stenosis. The observation will be the measurement of [F-18]RGD-K5 uptake by the carotid artery plaque after intravenous administration of this radiolabeled tracer using PET imaging.~[F-18] RDG-K5: Up to fifteen (15) subjects with carotid stenosis >50% who are undergoing planned carotid endarterectomy will be imaged under PET with [F-18] RDG-K5"
102031|NCT01968135|B3|Baseline|Total|Total of all reporting groups
102032|NCT01968135|B2|Baseline|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill~Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
102033|NCT01968135|B1|Baseline|Sugar Pill|"Placebo Sugar Pill~Placebo Sugar Pill: Placebo Sugar Pill"
102034|NCT01968135|P2|Participant Flow|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill~Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
102035|NCT01968135|P1|Participant Flow|Sugar Pill|"Placebo Sugar Pill~Placebo Sugar Pill: Placebo Sugar Pill"
102036|NCT01968135|O2|Outcome|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill~Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
102037|NCT01968135|O1|Outcome|Sugar Pill|"Placebo Sugar Pill~Placebo Sugar Pill: Placebo Sugar Pill"
102038|NCT01968135|O2|Outcome|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill~Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
102039|NCT01968135|O1|Outcome|Sugar Pill|"Placebo Sugar Pill~Placebo Sugar Pill: Placebo Sugar Pill"
102040|NCT01968135|O2|Outcome|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill~Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
102041|NCT01968135|O1|Outcome|Sugar Pill|"Placebo Sugar Pill~Placebo Sugar Pill: Placebo Sugar Pill"
102042|NCT01968135|O2|Outcome|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill~Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
102043|NCT01968135|O1|Outcome|Sugar Pill|"Placebo Sugar Pill~Placebo Sugar Pill: Placebo Sugar Pill"
102044|NCT01968135|E2|Reported Event|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill~Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
102045|NCT01968135|E1|Reported Event|Sugar Pill|"Placebo Sugar Pill~Placebo Sugar Pill: Placebo Sugar Pill"
102046|NCT01968057|B1|Baseline|Baricitinib + Ciclosporin|"4 mg baricitinib administered orally on Day 1 of Period 1.~4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2."
102047|NCT01968057|P1|Participant Flow|Baricitinib + Ciclosporin|"4 milligrams (mg) baricitinib administered orally on Day 1 of Period 1.~4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2."
102048|NCT01968057|O2|Outcome|Baricitinib + Ciclosporin|4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2.
102049|NCT01968057|O1|Outcome|Baricitinib|4 mg baricitinib administered orally on Day 1 of Period 1.
102050|NCT01968057|O2|Outcome|Baricitinib + Ciclosporin|4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2.
102051|NCT01968057|O1|Outcome|Baricitinib|4 mg baricitinib administered orally on Day 1 of Period 1.
102052|NCT01968057|O2|Outcome|Baricitinib + Ciclosporin|4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2.
102053|NCT01968057|O1|Outcome|Baricitinib|4 mg baricitinib administered orally on Day 1 of Period 1.
102054|NCT01968057|E2|Reported Event|Baricitinib + Ciclosporin|"4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2.~Adverse events are reported from postdose on Day 4 up to Day 14."
102055|NCT01968057|E1|Reported Event|Baricitinib|"4 mg baricitinib administered orally on Day 1 of Period 1.~Adverse events are reported from baseline through predose on Day 4."
102056|NCT01967940|B4|Baseline|Total|Total of all reporting groups
102057|NCT01967940|B3|Baseline|Part 1 Randomized Cohort Placebo|Placebo once daily + their current failing regimen for 10 days
102058|NCT01967940|B2|Baseline|Part 1 Randomized Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
102059|NCT01967940|B1|Baseline|Part 1 Sentinel Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
102060|NCT01967940|P3|Participant Flow|Part 1 Randomized Cohort Placebo, Then Part 2 E/C/F/TAF+ATV|"Part 1: Placebo once daily + their current failing regimen for 10 days~Part 2: Following a 14-day washout period, participants received E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks."
102205|NCT01967147|E3|Reported Event|Saline|All subjects exposed to Saline
102206|NCT01967147|E2|Reported Event|Systane Balance|All subjects exposed to Systane® Balance
102062|NCT01967940|P1|Participant Flow|Part 1 Sentinel Cohort TAF, Then Part 2 E/C/F/TAF+ATV|"Part 1: Tenofovir alafenamide (TAF) 25 mg tablet once daily + their current failing regimen for 10 days~Part 2: Following a 14-day washout period, participants who had a > 0.5 log10 decline in HIV-1 RNA received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) single-tablet regimen (STR) plus atazanavir (ATV) 300 mg once daily for 48 weeks."
102063|NCT01967940|O3|Outcome|Part 1 Randomized Cohort Placebo|Placebo once daily + their current failing regimen for 10 days
102064|NCT01967940|O2|Outcome|Part 1 Randomized Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
102065|NCT01967940|O1|Outcome|Part 1 Sentinel Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
102066|NCT01967940|O3|Outcome|Part 1 Randomized Cohort Placebo|Placebo once daily + their current failing regimen for 10 days
102067|NCT01967940|O2|Outcome|Part 1 Randomized Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
102068|NCT01967940|O1|Outcome|Part 1 Sentinel Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
102069|NCT01967940|E3|Reported Event|Part 1 Randomized Cohort Placebo|Placebo once daily + their current failing regimen for 10 days
102070|NCT01967940|E2|Reported Event|Part 1 Randomized Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
102071|NCT01967940|E1|Reported Event|Part 1 Sentinel Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
102072|NCT01967836|B1|Baseline|Glad Press 'n Seal|"Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line~Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering"
102073|NCT01967836|P1|Participant Flow|Glad Press 'n Seal|"Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line~Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering as a means of bathing"
102074|NCT01967836|O1|Outcome|Glad Press 'n Seal|"Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line~Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering.~Subject specific characteristics 19 subjects in oncology clinic sites were approached to participate; 9 refused participation~1 subject in ambulatory clinic was approached and was consented~Nurses inspection of central line site on study participants at next clinic visit with return of subject patient questionnaire evaluation of use of product device with showing 27 nurse evaluations were completed for analysis"
102075|NCT01967836|O1|Outcome|Glad Press 'n Seal|"Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line~Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering.~Subject specific characteristics 19 subjects in oncology clinic sites were approached to participate; 9 refused participation~1 subject in ambulatory clinic was approached and was consented"
102076|NCT01967836|O1|Outcome|Glad Press 'n Seal|"Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line~Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering.~Subject specific characteristics 19 subjects in oncology clinic sites were approached to participate; 9 refused participation~1 subject in ambulatory clinic was approached and was consented"
102077|NCT01967836|E1|Reported Event|Glad Press 'n Seal|"Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line~Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering as a means of bathing"
102078|NCT01967784|B1|Baseline|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
102079|NCT01967784|P1|Participant Flow|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
102080|NCT01967784|O1|Outcome|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
102081|NCT01967784|O1|Outcome|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
102082|NCT01967784|O1|Outcome|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
102083|NCT01967784|O1|Outcome|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
102084|NCT01967784|O1|Outcome|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
102085|NCT01967784|E1|Reported Event|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
102086|NCT01967732|B3|Baseline|Total|Total of all reporting groups
102087|NCT01967732|B2|Baseline|Group 2|"This population comprises the following sequences:~Sequence THS 2.2 then NNS~Sequence NNS then THS 2.2"
102088|NCT01967732|B1|Baseline|Group 1|"This population comprises the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
102089|NCT01967732|P4|Participant Flow|NNS Then THS 2.2|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single administration of NNS)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of THS 2.2)."
102090|NCT01967732|P3|Participant Flow|THS 2.2 Then NNS|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of THS 2.2)~Day 2 = wash-out~Day 3 = 2nd intervention (single administration of NNS)"
102091|NCT01967732|P2|Participant Flow|CC Then THS 2.2|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of CC)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of THS 2.2)."
102092|NCT01967732|P1|Participant Flow|THS 2.2 Then CC|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of THS 2.2)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of CC)."
102093|NCT01967732|O4|Outcome|NNS - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then NNS~Sequence NNS then THS 2.2"
102094|NCT01967732|O3|Outcome|THS 2.2 - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then NNS~Sequence NNS then THS 2.2"
102095|NCT01967732|O2|Outcome|CC - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
102096|NCT01967732|O1|Outcome|THS 2.2 - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
102097|NCT01967732|O4|Outcome|NNS - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then NNS~Sequence NNS then THS 2.2"
102098|NCT01967732|O3|Outcome|THS 2.2 - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then NNS~Sequence NNS then THS 2.2"
102099|NCT01967732|O2|Outcome|CC - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
102100|NCT01967732|O1|Outcome|THS 2.2 - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
102101|NCT01967732|E2|Reported Event|Group 2|"This population comprises the following sequences:~Sequence THS 2.2 then NNS~Sequence NNS then THS 2.2"
102102|NCT01967732|E1|Reported Event|Group 1|"This population comprises the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
102103|NCT01967719|B3|Baseline|Total|Total of all reporting groups
102104|NCT01967719|B2|Baseline|Group 2|"This population comprises the following sequences:~Sequence mTHS 2.2 then NNS~Sequence NNS then mTHS 2.2"
102105|NCT01967719|B1|Baseline|Group 1|"This population comprises the following sequences:~Sequence mTHS 2.2 then mCC~Sequence mCC then mTHS 2.2"
102106|NCT01967719|P4|Participant Flow|NNS Then mTHS 2.2|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single administration of NNS)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of mTHS 2.2)."
102107|NCT01967719|P3|Participant Flow|mTHS 2.2 Then NNS|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mTHS 2.2)~Day 2 = wash-out~Day 3 = 2nd intervention (single administration of NNS)"
102108|NCT01967719|P2|Participant Flow|mCC Then mTHS 2.2|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mCC)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of mTHS 2.2)."
102109|NCT01967719|P1|Participant Flow|mTHS 2.2 Then mCC|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mTHS 2.2)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of mCC)."
102110|NCT01967719|O4|Outcome|NNS - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then NNS~Sequence NNS then mTHS 2.2"
102111|NCT01967719|O3|Outcome|mTHS 2.2 - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then NNS~Sequence NNS then mTHS 2.2"
102112|NCT01967719|O2|Outcome|mCC - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then mCC~Sequence mCC then mTHS 2.2"
102113|NCT01967719|O1|Outcome|mTHS 2.2 - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then mCC~Sequence mCC then mTHS 2.2."
102114|NCT01967719|O4|Outcome|NNS - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then NNS~Sequence NNS then mTHS 2.2"
102115|NCT01967719|O3|Outcome|mTHS 2.2 - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then NNS~Sequence NNS then mTHS 2.2"
102116|NCT01967719|O2|Outcome|mCC - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then mCC~Sequence mCC then mTHS 2.2"
102117|NCT01967719|O1|Outcome|mTHS 2.2 - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then mCC~Sequence mCC then mTHS 2.2"
102118|NCT01967719|E3|Reported Event|Enrolled But Not Randomized|Subjects who tried the mTHS 2.2 at Admission (Day -1) but were not randomized in 1 of the 2 groups as they were back-up subjects
102119|NCT01967719|E2|Reported Event|Group 2|"This population comprises the following sequences:~Sequence mTHS 2.2 then NNS~Sequence NNS then mTHS 2.2"
102120|NCT01967719|E1|Reported Event|Group 1|"This population comprises the following sequences:~Sequence mTHS 2.2 then mCC~Sequence mCC then mTHS 2.2"
102121|NCT01967706|B3|Baseline|Total|Total of all reporting groups
102122|NCT01967706|B2|Baseline|Group 2|"This population comprises the following sequences:~Sequence mTHS then NRT~Sequence NRT then mTHS"
102123|NCT01967706|B1|Baseline|Group 1|"This population comprises the following sequences:~Sequence mTHS then mCC~Sequence mCC then mTHS"
102124|NCT01967706|P4|Participant Flow|NRT Then mTHS|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single administration of NRT)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of mTHS)."
102125|NCT01967706|P3|Participant Flow|mTHS Then NRT|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mTHS)~Day 2 = wash-out~Day 3 = 2nd intervention (single administration of NRT)"
102126|NCT01967706|P2|Participant Flow|mCC Then mTHS|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mCC)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of mTHS)."
102127|NCT01967706|P1|Participant Flow|mTHS Then mCC|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mTHS)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of mCC)."
102128|NCT01967706|O4|Outcome|NRT - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS then NRT~Sequence NRT then mTHS"
102129|NCT01967706|O3|Outcome|mTHS - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS then NRT~Sequence NRT then mTHS"
102130|NCT01967706|O2|Outcome|mCC - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS then mCC~Sequence mCC then mTHS"
102131|NCT01967706|O1|Outcome|mTHS - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS then mCC~Sequence mCC then mTHS"
102132|NCT01967706|O4|Outcome|NRT - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS then NRT~Sequence NRT then mTHS"
102133|NCT01967706|O3|Outcome|mTHS - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS then NRT~Sequence NRT then mTHS"
102134|NCT01967706|O2|Outcome|mCC - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS then mCC~Sequence mCC then mTHS"
102135|NCT01967706|O1|Outcome|mTHS - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS then mCC~Sequence mCC then mTHS"
102136|NCT01967706|E3|Reported Event|Enrolled But Not Randomized|Subjects who tried the mTHS at Admission (Day -1) but were not randomized in 1 of the 2 groups as they were back-up subjects
102137|NCT01967706|E2|Reported Event|Group 2|"This population comprises the following sequences:~Sequence mTHS then NRT~Sequence NRT then mTHS"
102138|NCT01967706|E1|Reported Event|Group 1|"This population comprises the following sequences:~Sequence mTHS then mCC~Sequence mCC then mTHS"
102139|NCT01967628|B3|Baseline|Total|Total of all reporting groups
102140|NCT01967628|B2|Baseline|Placebo ASL|Analysis of airway surface liquid in those taking placebo.
102141|NCT01967628|B1|Baseline|Vitamin D ASL|Analysis of airway surface liquid in those taking Vitamin D
102142|NCT01967628|P2|Participant Flow|Sugar Capsule|"Placebo comparator made of sugar in a capsule~Placebo Sugar Pill"
102143|NCT01967628|P1|Participant Flow|Vitamin D3|"Vitamin D3 (1000 IUs) daily for 3 months.~Vitamin D3 (cholecalciferol)"
102144|NCT01967628|O2|Outcome|Sugar Capsule|"Placebo comparator made of sugar in a capsule~Placebo Sugar Pill"
102145|NCT01967628|O1|Outcome|Vitamin D3|Vitamin D3 (cholecalciferol) at 1000 international units daily for 3 months
102146|NCT01967628|E2|Reported Event|Placebo Airway Surface Liquid|Analysis of airway surface liquid in those taking placebo.
102147|NCT01967628|E1|Reported Event|Vitamin D Airway Surface Liquid|Analysis of airway surface liquid in those taking Vitamin D
102148|NCT01967550|B3|Baseline|Total|Total of all reporting groups
102149|NCT01967550|B2|Baseline|Placebo|Vehicle control
102150|NCT01967550|B1|Baseline|Diclofenac Diethylamine, DDEA 2.32% Gel|"diclofenac diethylamine, DDEA 2.32% gel~diclofenac diethylamine, DDEA 2.32% gel"
102151|NCT01967550|P2|Participant Flow|Placebo|Vehicle control
102152|NCT01967550|P1|Participant Flow|Diclofenac Diethylamine, DDEA 2.32% Gel|"diclofenac diethylamine, DDEA 2.32% gel~diclofenac diethylamine, DDEA 2.32% gel"
102153|NCT01967550|O2|Outcome|Placebo|Vehicle control
102154|NCT01967550|O1|Outcome|Diclofenac Diethylamine, DDEA 2.32% Gel|"diclofenac diethylamine, DDEA 2.32% gel~diclofenac diethylamine, DDEA 2.32% gel"
102155|NCT01967550|E2|Reported Event|Placebo|Vehicle control
102156|NCT01967550|E1|Reported Event|Diclofenac Diethylamine, DDEA 2.32% Gel|"diclofenac diethylamine, DDEA 2.32% gel~diclofenac diethylamine, DDEA 2.32% gel"
102157|NCT01967342|B4|Baseline|Total|Total of all reporting groups
102158|NCT01967342|B3|Baseline|Pain Ed|Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
102159|NCT01967342|B2|Baseline|CBT for Pain|Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
102160|NCT01967342|B1|Baseline|Usual Care|Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.
102207|NCT01967147|E1|Reported Event|Pretreatment|All subjects prior to exposure to investigational product
102208|NCT01967121|B4|Baseline|Total|Total of all reporting groups
102161|NCT01967342|P3|Participant Flow|Pain Ed|Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
102162|NCT01967342|P2|Participant Flow|CBT for Pain|Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
102163|NCT01967342|P1|Participant Flow|Usual Care|Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.
102164|NCT01967342|O3|Outcome|Pain Ed|Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
102165|NCT01967342|O2|Outcome|CBT for Pain|Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
102166|NCT01967342|O1|Outcome|Usual Care|Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.
102167|NCT01967342|O3|Outcome|Pain Ed|Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
102168|NCT01967342|O2|Outcome|CBT for Pain|Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
102169|NCT01967342|O1|Outcome|Usual Care|Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.
102170|NCT01967342|O3|Outcome|Pain Ed|Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
102171|NCT01967342|O2|Outcome|CBT for Pain|Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
102172|NCT01967342|O1|Outcome|Usual Care|Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.
102173|NCT01967342|O3|Outcome|Pain Ed|Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
102174|NCT01967342|O2|Outcome|CBT for Pain|Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
102209|NCT01967121|B3|Baseline|Control|This is a control group where subjects will not perform an intervention.
102175|NCT01967342|O1|Outcome|Usual Care|Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.
102176|NCT01967342|E3|Reported Event|Pain Ed|Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
102177|NCT01967342|E2|Reported Event|CBT for Pain|Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
102178|NCT01967342|E1|Reported Event|Usual Care|Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.
102179|NCT01967277|B3|Baseline|Total|Total of all reporting groups
102180|NCT01967277|B2|Baseline|Handi-Dome Laser|"Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.~Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks."
102181|NCT01967277|B1|Baseline|Incandescent Red Light Source|"Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.~Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks."
102182|NCT01967277|P2|Participant Flow|Handi-Dome Laser|"Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.~Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks."
102183|NCT01967277|P1|Participant Flow|Incandescent Red Light Source|"Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.~Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks."
102184|NCT01967277|O2|Outcome|Handi-Dome Laser|"Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.~Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks."
102185|NCT01967277|O1|Outcome|Incandescent Red Light Source|"Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.~Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks."
102186|NCT01967277|O2|Outcome|Handi-Dome Laser|"Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.~Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks."
102187|NCT01967277|O1|Outcome|Incandescent Red Light Source|"Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.~Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks."
102188|NCT01967277|E2|Reported Event|Handi-Dome Laser|"Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.~Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks."
102189|NCT01967277|E1|Reported Event|Incandescent Red Light Source|"Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.~Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks."
102190|NCT01967147|B3|Baseline|Total|Total of all reporting groups
102191|NCT01967147|B2|Baseline|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
102192|NCT01967147|B1|Baseline|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
102193|NCT01967147|P2|Participant Flow|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
102194|NCT01967147|P1|Participant Flow|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
102195|NCT01967147|O2|Outcome|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
102196|NCT01967147|O1|Outcome|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
102197|NCT01967147|O2|Outcome|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
102198|NCT01967147|O1|Outcome|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
102199|NCT01967147|O2|Outcome|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
102200|NCT01967147|O1|Outcome|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
102201|NCT01967147|O2|Outcome|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
102202|NCT01967147|O1|Outcome|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
102203|NCT01967147|O2|Outcome|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
102204|NCT01967147|O1|Outcome|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
102210|NCT01967121|B2|Baseline|Ice Application|"A randomized pre and post-test research design will be used to compare three interventions (control, ice, compex) to alleviate the physical symptoms of delayed-onset muscle soreness (DOMS).~Ice application: Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present"
102211|NCT01967121|B1|Baseline|'Compex Unit's Active Recovery® Program'|"The Compex electrical stimulation system utilized in this study is intended for external application with electrodes to create a muscular contraction and help enhance recovery after eccentric muscular activity.~Compex unit's Active Recovery® program: Compex unit's Active Recovery® program will be performed for 15 minutes once per day."
102212|NCT01967121|P3|Participant Flow|Control|This is a control group where subjects will not perform an intervention.
102213|NCT01967121|P2|Participant Flow|Ice Application|"A randomized pre and post-test research design will be used to compare three interventions (control, ice, compex) to alleviate the physical symptoms of delayed-onset muscle soreness (DOMS).~Ice application: Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present"
102214|NCT01967121|P1|Participant Flow|'Compex Unit's Active Recovery® Program'|"The Compex electrical stimulation system utilized in this study is intended for external application with electrodes to create a muscular contraction and help enhance recovery after eccentric muscular activity.~Compex unit's Active Recovery® program: Compex unit's Active Recovery® program will be performed for 15 minutes once per day."
102215|NCT01967121|O3|Outcome|Control|This is a control group where subjects will not perform an intervention.
102216|NCT01967121|O2|Outcome|Ice Application|"A randomized pre and post-test research design will be used to compare three interventions (control, ice, compex) to alleviate the physical symptoms of delayed-onset muscle soreness (DOMS).~Ice application: Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present"
102217|NCT01967121|O1|Outcome|'Compex Unit's Active Recovery® Program'|"The Compex electrical stimulation system utilized in this study is intended for external application with electrodes to create a muscular contraction and help enhance recovery after eccentric muscular activity.~Compex unit's Active Recovery® program: Compex unit's Active Recovery® program will be performed for 15 minutes once per day."
102218|NCT01967121|E3|Reported Event|Control|This is a control group where subjects will not perform an intervention.
102219|NCT01967121|E2|Reported Event|Ice Application|"A randomized pre and post-test research design will be used to compare three interventions (control, ice, compex) to alleviate the physical symptoms of delayed-onset muscle soreness (DOMS).~Ice application: Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present"
102220|NCT01967121|E1|Reported Event|'Compex Unit's Active Recovery® Program'|"The Compex electrical stimulation system utilized in this study is intended for external application with electrodes to create a muscular contraction and help enhance recovery after eccentric muscular activity.~Compex unit's Active Recovery® program: Compex unit's Active Recovery® program will be performed for 15 minutes once per day."
102221|NCT01967069|B3|Baseline|Total|Total of all reporting groups
102222|NCT01967069|B2|Baseline|Vehicle Spray|"Vehicle Spray twice daily~Vehicle Spray"
102223|NCT01967069|B1|Baseline|DFD01 Spray|"DFD01 Spray twice daily~DFD01 Spray"
102224|NCT01967069|P2|Participant Flow|Vehicle Spray|"Vehicle Spray twice daily~Vehicle Spray"
102225|NCT01967069|P1|Participant Flow|DFD01 Spray|"DFD01 Spray twice daily~DFD01 Spray"
102226|NCT01967069|O2|Outcome|Vehicle Spray|"Vehicle Spray twice daily~Vehicle Spray"
102227|NCT01967069|O1|Outcome|DFD01 Spray|"DFD01 Spray twice daily~DFD01 Spray"
102228|NCT01967069|E2|Reported Event|Vehicle Spray|"Vehicle Spray twice daily~Vehicle Spray"
102229|NCT01967069|E1|Reported Event|DFD01 Spray|"DFD01 Spray twice daily~DFD01 Spray"
102230|NCT01966926|B3|Baseline|Total|Total of all reporting groups
102231|NCT01966926|B2|Baseline|Weekly Weight Tracking|weekly weighing frequency instructions and tips
102232|NCT01966926|B1|Baseline|Daily Weight Tracking|daily weighing frequency instructions and tips
102233|NCT01966926|P2|Participant Flow|Weekly Weight Tracking|weekly weighing frequency instructions and tips
102234|NCT01966926|P1|Participant Flow|Daily Weight Tracking|daily weighing frequency instructions and tips
102235|NCT01966926|O2|Outcome|Weekly Weight Tracking|weekly weighing frequency instructions and tips
102236|NCT01966926|O1|Outcome|Daily Weight Tracking|daily weighing frequency instructions and tips
102237|NCT01966926|O2|Outcome|Weekly Weight Tracking|weekly weighing frequency instructions and tips
102238|NCT01966926|O1|Outcome|Daily Weight Tracking|daily weighing frequency instructions and tips
102239|NCT01966926|O2|Outcome|Weekly Weight Tracking|weekly weighing frequency instructions and tips
102240|NCT01966926|O1|Outcome|Daily Weight Tracking|daily weighing frequency instructions and tips
102241|NCT01966926|O2|Outcome|Weekly Weight Tracking|weekly weighing frequency instructions and tips
102242|NCT01966926|O1|Outcome|Daily Weight Tracking|daily weighing frequency instructions and tips
102243|NCT01966926|O2|Outcome|Weekly Weight Tracking|weekly weighing frequency instructions and tips
102244|NCT01966926|O1|Outcome|Daily Weight Tracking|daily weighing frequency instructions and tips
102245|NCT01966926|O2|Outcome|Weekly Weight Tracking|weekly weighing frequency instructions and tips
102246|NCT01966926|O1|Outcome|Daily Weight Tracking|daily weighing frequency instructions and tips
102247|NCT01966926|E2|Reported Event|Weekly Weight Tracking|weekly weighing frequency instructions and tips
102248|NCT01966926|E1|Reported Event|Daily Weight Tracking|daily weighing frequency instructions and tips
102249|NCT01966770|B1|Baseline|Overall Study Group|All participants were habitual contact lens wearers and all participants wore Day 1 followed by Day 2 lenses
102250|NCT01966770|P1|Participant Flow|Overall Study Group|All participants were habitual contact lens wearers and all participants wore Day 1 followed by Day 2 lenses
102251|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102252|NCT01966770|O5|Outcome|PCM SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102255|NCT01966770|O2|Outcome|F55 ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
102256|NCT01966770|O1|Outcome|F55 SPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
102257|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102258|NCT01966770|O5|Outcome|B55 SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102259|NCT01966770|O4|Outcome|AV SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
102260|NCT01966770|O3|Outcome|B55 SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
102261|NCT01966770|O2|Outcome|B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
102262|NCT01966770|O1|Outcome|B55 SPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
102263|NCT01966770|O1|Outcome|PCM SPHERE LENS P3 / BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102264|NCT01966770|O1|Outcome|F55 SPHERE LENS P2 / BIOFINITY LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102265|NCT01966770|O1|Outcome|F55 SPHERE LENS P1 / F55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
102266|NCT01966770|O1|Outcome|B55 SPHERE LENS P3 / BF SPHERE LENS P3|Subjects wore contralateral lenses. Pair 3 Biomedics 55 Sphere (B55 SPHERE LENS P3) in one eye and Biofinity (BF SPHERE LENS P3) in the other.
102267|NCT01966770|O1|Outcome|B55 SPHERE LENS P2 / AV SPHERE LENS P2|Subjects wore contralateral lenses. Pair 2 Biomedics 55 Sphere (B55 SPHERE LENS P2) in one eye and Avairia sphere (AV SPHERE LENS P2) in the other.
102268|NCT01966770|O1|Outcome|B55 SPHERE LENS P1 / B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Pair 1 Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
102269|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102270|NCT01966770|O5|Outcome|PCM SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102271|NCT01966770|O4|Outcome|BF SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102272|NCT01966770|O3|Outcome|F55 SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102273|NCT01966770|O2|Outcome|F55 ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
102274|NCT01966770|O1|Outcome|F55 SPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
102275|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102276|NCT01966770|O5|Outcome|PCM SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102277|NCT01966770|O4|Outcome|BF SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102278|NCT01966770|O3|Outcome|F55 SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102279|NCT01966770|O2|Outcome|F55 ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
102280|NCT01966770|O1|Outcome|F55 SPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
102281|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102282|NCT01966770|O5|Outcome|PCM SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102283|NCT01966770|O4|Outcome|BF SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102284|NCT01966770|O3|Outcome|F55 SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102285|NCT01966770|O2|Outcome|F55 ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
102286|NCT01966770|O1|Outcome|F55 SPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
102287|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102288|NCT01966770|O5|Outcome|B55 SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102289|NCT01966770|O4|Outcome|AV SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
102290|NCT01966770|O3|Outcome|B55 SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
103226|NCT01963767|B2|Baseline|Placebo|Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
102291|NCT01966770|O2|Outcome|B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
102292|NCT01966770|O1|Outcome|B55 SPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
102293|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102294|NCT01966770|O5|Outcome|B55 SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102295|NCT01966770|O4|Outcome|AV SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
102296|NCT01966770|O3|Outcome|B55 SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
102297|NCT01966770|O2|Outcome|B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
102298|NCT01966770|O1|Outcome|B55 SPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
102299|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102300|NCT01966770|O5|Outcome|B55 SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102301|NCT01966770|O4|Outcome|AV SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
102302|NCT01966770|O3|Outcome|B55 SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
102303|NCT01966770|O2|Outcome|B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
102304|NCT01966770|O1|Outcome|B55 SPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
102305|NCT01966770|O1|Outcome|Habitual Lens|Subjects presented wearing habitual lenses prior to dispense of study lenses.
102306|NCT01966770|O1|Outcome|Habitual Lens|Subjects presented wearing habitual lenses prior to dispense of study lenses.
102307|NCT01966770|O1|Outcome|Habitual Lens|Subjects presented wearing habitual lenses prior to dispense of study lenses.
102308|NCT01966770|O1|Outcome|PCM SPHERE LENS P3 / BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102309|NCT01966770|O1|Outcome|F55 SPHERE LENS P2 / BIOFINITY LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102310|NCT01966770|O1|Outcome|F55 SPHERE LENS P1 / F55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
102311|NCT01966770|O1|Outcome|PCM SPHERE LENS P3 / BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102312|NCT01966770|O1|Outcome|F55 SPHERE LENS P2 / BIOFINITY LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102313|NCT01966770|O1|Outcome|F55 SPHERE LENS P1 / F55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
102314|NCT01966770|O1|Outcome|B55 SPHERE LENS P3 / BF SPHERE LENS P3|Subjects wore contralateral lenses. Pair 3 Biomedics 55 Sphere (B55 SPHERE LENS P3) in one eye and Biofinity (BF SPHERE LENS P3) in the other.
102315|NCT01966770|O1|Outcome|B55 SPHERE LENS P2 / AV SPHERE LENS P2|Subjects wore contralateral lenses. Pair 2 Biomedics 55 Sphere (B55 SPHERE LENS P2) in one eye and Avairia sphere (AV SPHERE LENS P2) in the other.
102316|NCT01966770|O1|Outcome|B55 SPHERE LENS P1 / B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Pair 1 Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
102317|NCT01966770|O1|Outcome|B55 SPHERE LENS P3 / BF SPHERE LENS P3|Subjects wore contralateral lenses. Pair 3 Biomedics 55 Sphere (B55 SPHERE LENS P3) in one eye and Biofinity (BF SPHERE LENS P3) in the other.
102318|NCT01966770|O1|Outcome|B55 SPHERE LENS P2 / AV SPHERE LENS P2|Subjects wore contralateral lenses. Pair 2 Biomedics 55 Sphere (B55 SPHERE LENS P2) in one eye and Avairia sphere (AV SPHERE LENS P2) in the other.
102319|NCT01966770|O1|Outcome|B55 SPHERE LENS P1 / B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Pair 1 Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
102320|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102321|NCT01966770|O5|Outcome|PCM SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102322|NCT01966770|O4|Outcome|BF SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102323|NCT01966770|O3|Outcome|F55 SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102324|NCT01966770|O2|Outcome|F55 ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
102325|NCT01966770|O1|Outcome|F55 SPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
102326|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
104115|NCT01958671|O1|Outcome|Ertugliflozin 5 mg|Participants received ertugliflozin 5 mg once daily for 26 weeks.
102327|NCT01966770|O5|Outcome|PCM SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102328|NCT01966770|O4|Outcome|BF SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102329|NCT01966770|O3|Outcome|F55 SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102330|NCT01966770|O2|Outcome|F55 ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
102331|NCT01966770|O1|Outcome|F55 SPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
102332|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102333|NCT01966770|O5|Outcome|B55 SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102334|NCT01966770|O4|Outcome|AV SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
102335|NCT01966770|O3|Outcome|B55 SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
102336|NCT01966770|O2|Outcome|B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
102337|NCT01966770|O1|Outcome|B55 SPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
102338|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102339|NCT01966770|O5|Outcome|B55 SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
102340|NCT01966770|O4|Outcome|AV SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
102341|NCT01966770|O3|Outcome|B55 SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
102342|NCT01966770|O2|Outcome|B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
102343|NCT01966770|O1|Outcome|B55 SPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
102344|NCT01966770|O7|Outcome|F55 ASPHERE LENS|Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
102345|NCT01966770|O6|Outcome|F55 SPHERE LENS|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
102346|NCT01966770|O5|Outcome|PCM SPHERE LENS|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
102347|NCT01966770|O4|Outcome|AV SPHERE LENS|Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
102348|NCT01966770|O3|Outcome|BF SPHERE LENS|Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
102349|NCT01966770|O2|Outcome|B55 SPHERE LENS|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
102350|NCT01966770|O1|Outcome|B55 PREMIER ASPHERE LENS|Subjects wore contralateral lenses. Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
102351|NCT01966770|O1|Outcome|Habitual Lens|Subjects presented wearing habitual lenses prior to dispense of study lenses.
102352|NCT01966770|E6|Reported Event|Pair 6 (Omafilcon A / Comfilcon A)|Randomized to contra lateral lens pair 6 (omafilcon A hydrogel / comfilcon A silicone)
102353|NCT01966770|E5|Reported Event|Pair 5 (Methafilcon A / Comfilcon A)|Randomized to contra lateral lens pair 5 (methafilcon A hydrogel / comfilcon A silicone)
102354|NCT01966770|E4|Reported Event|Pair 4 (Methafilcon A / Methafilcon A)|Randomized to contra lateral lens pair 4 (methafilcon A hydrogel sphere / methafilcon A hydrogel asphere)
102355|NCT01966770|E3|Reported Event|Pair 3 (Ocufilcon D / Comfilcon A)|Randomized to contra lateral lens pair 3 (ocufilcon D hydrogel / comfilcon A silicone)
102356|NCT01966770|E2|Reported Event|Pair 2 (Ocufilcon D / Enfilcon A)|Randomized to contra lateral lens pair 2 (ocufilcon D hydrogel / enfilcon A silicone)
102357|NCT01966770|E1|Reported Event|Pair 1 (Ocufilcon D / Ocufilcon D)|Randomized to contra lateral lens pair 1 (ocufilcon D hydrogel / ocufilcon D hydrogel)
102358|NCT01966718|B1|Baseline|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks~Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
102359|NCT01966718|P1|Participant Flow|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks~Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
102360|NCT01966718|O1|Outcome|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks~Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
102361|NCT01966718|O1|Outcome|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks~Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
102362|NCT01966718|O1|Outcome|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks~Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
102363|NCT01966718|O2|Outcome|Tender Joints|Change in number of tender joints exhibited at week 16, calculated by subtracting week 16 total from baseline total.
102364|NCT01966718|O1|Outcome|Swollen Joints|Change in number of swollen joints participants exhibited at week 16 (Calculated by subtracting week 16 total from baseline total. Positive numbers indicate number at week 16 was less than at baseline).
102365|NCT01966718|E1|Reported Event|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks~Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
102366|NCT01966458|B3|Baseline|Total|Total of all reporting groups
102367|NCT01966458|B2|Baseline|Control LVAD|Control LVAD: Any FDA-approved LVAD for destination therapy.
102368|NCT01966458|B1|Baseline|HeartWare® VAS|HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
102369|NCT01966458|P2|Participant Flow|Control Left Ventricular Assist Device (LVAD)|Control Left Ventricular Assist Device (LVAD): Any Food and Drug Administration (FDA)-approved LVAD for destination therapy.
102370|NCT01966458|P1|Participant Flow|HeartWare® Ventricular Assist System (VAS)|HeartWare® Ventricular Assist System (VAS): The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
102371|NCT01966458|O2|Outcome|Control LVAD|Control LVAD: Any FDA-approved LVAD for destination therapy.
102372|NCT01966458|O1|Outcome|HeartWare® VAS|HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
102373|NCT01966458|O1|Outcome|HeartWare® VAS|HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
102374|NCT01966458|O2|Outcome|Control LVAD|Control LVAD: Any FDA-approved LVAD for destination therapy.
102375|NCT01966458|O1|Outcome|HeartWare® VAS|HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
102376|NCT01966458|E2|Reported Event|Control LVAD|"Implant of FDA-approved LVAD approved for destination therapy~Control LVAD: Any FDA-approved LVAD for destination therapy."
102377|NCT01966458|E1|Reported Event|HeartWare® VAS|"Implant of HeartWare® Ventricular Assist System~HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use."
102378|NCT01966432|B4|Baseline|Total|Total of all reporting groups
102379|NCT01966432|B3|Baseline|S Group|Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
102380|NCT01966432|B2|Baseline|SBI Group|"Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.~Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
102381|NCT01966432|B1|Baseline|SBIRT Group|"Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.~Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.~Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
102382|NCT01966432|P3|Participant Flow|S Group|Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
102383|NCT01966432|P2|Participant Flow|SBI Group|"Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.~Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
102384|NCT01966432|P1|Participant Flow|SBIRT Group|"Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.~Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.~Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
102385|NCT01966432|O3|Outcome|S Group|Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
102386|NCT01966432|O2|Outcome|SBI Group|"Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.~Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
102387|NCT01966432|O1|Outcome|SBIRT Group|"Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.~Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.~Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
102388|NCT01966432|O3|Outcome|S Group|Screening group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
102389|NCT01966432|O2|Outcome|SBI Group|"Screening, Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.~Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
102390|NCT01966432|O1|Outcome|SBIRT Group|"Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.~Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.~Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
102391|NCT01966432|O3|Outcome|S Group|Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
102392|NCT01966432|O2|Outcome|SBI Group|"Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.~Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
102393|NCT01966432|O1|Outcome|SBIRT Group|"Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.~Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.~Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
102394|NCT01966432|O3|Outcome|S Group|Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
102395|NCT01966432|O2|Outcome|SBI Group|"Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.~Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
102396|NCT01966432|O1|Outcome|SBIRT Group|"Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.~Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.~Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
102397|NCT01966432|O3|Outcome|S Group|Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
102398|NCT01966432|O2|Outcome|SBI Group|"Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.~Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
102399|NCT01966432|O1|Outcome|SBIRT Group|"Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.~Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.~Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
102400|NCT01966432|E3|Reported Event|S Group|Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
102401|NCT01966432|E2|Reported Event|SBI Group|"Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.~Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
102402|NCT01966432|E1|Reported Event|SBIRT Group|"Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.~Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.~Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
102403|NCT01966380|B1|Baseline|Leia and Hydroactive Surgical Dressing|In the case of this study, participants served as their own control.
102404|NCT01966380|P2|Participant Flow|Cross-over Assignment Hydroactive Surgical Dressing|First intervention Hydroactive surgical dressing 5 Days, then second intervention Leia, 5 Days..
102405|NCT01966380|P1|Participant Flow|Cross-over Assignment Leia|First intervention Leia, 5 Days, then second intervention Hydroactive surgical dressing 5 Days.
102406|NCT01966380|O2|Outcome|Hydroactivate Surgical Dressing|Intervention: Device, Hydroactivate surgical dressing. Cross-over design, the patient was his own controll. 6 patients were treated in total.
102407|NCT01966380|O1|Outcome|Leia|Intervention: Device, Leia dressing Cross-over design, the patient was his own controll. 6 patients were treated in total.
102408|NCT01966380|E2|Reported Event|Hydroactive Surgical Dressing|"Intervention: Device: Hydroactive surgical dressing~Cross-over design, the patient was his own controll. 6 patients were treated in total."
102409|NCT01966380|E1|Reported Event|Leia|Intervention: Device, Leia dressing Cross-over design, the patient was his own controll. 6 patients were treated in total.
102410|NCT01966354|B4|Baseline|Total|Total of all reporting groups
102411|NCT01966354|B3|Baseline|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102497|NCT01966003|O2|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
102412|NCT01966354|B2|Baseline|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102413|NCT01966354|B1|Baseline|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102414|NCT01966354|P3|Participant Flow|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102415|NCT01966354|P2|Participant Flow|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102416|NCT01966354|P1|Participant Flow|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102417|NCT01966354|O3|Outcome|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102418|NCT01966354|O2|Outcome|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102419|NCT01966354|O1|Outcome|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102498|NCT01966003|O1|Outcome|ABP 215|Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
102499|NCT01966003|O2|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
104116|NCT01958671|O3|Outcome|Placebo|Participants received placebo to ertugliflozin once daily for 26 weeks.
102420|NCT01966354|O3|Outcome|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102421|NCT01966354|O2|Outcome|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102422|NCT01966354|O1|Outcome|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102423|NCT01966354|O3|Outcome|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102424|NCT01966354|O2|Outcome|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102425|NCT01966354|O1|Outcome|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102426|NCT01966354|O3|Outcome|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102427|NCT01966354|O2|Outcome|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102500|NCT01966003|O1|Outcome|ABP 215|Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
102501|NCT01966003|O2|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
107185|NCT01946243|O1|Outcome|Qualitative|Qualitative scan interpretation only
102428|NCT01966354|O1|Outcome|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102429|NCT01966354|O3|Outcome|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102430|NCT01966354|O2|Outcome|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102431|NCT01966354|O1|Outcome|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102432|NCT01966354|O3|Outcome|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102433|NCT01966354|O2|Outcome|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102434|NCT01966354|O1|Outcome|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102435|NCT01966354|E3|Reported Event|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102502|NCT01966003|O1|Outcome|ABP 215|Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
102503|NCT01966003|O2|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
107186|NCT01946243|O3|Outcome|Change|Change = VisQ - Qualitative
102436|NCT01966354|E2|Reported Event|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102437|NCT01966354|E1|Reported Event|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
102438|NCT01966159|B3|Baseline|Total|Total of all reporting groups
102439|NCT01966159|B2|Baseline|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
102440|NCT01966159|B1|Baseline|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
102441|NCT01966159|P2|Participant Flow|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
102442|NCT01966159|P1|Participant Flow|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
102443|NCT01966159|O2|Outcome|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
102444|NCT01966159|O1|Outcome|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
102445|NCT01966159|O2|Outcome|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
102446|NCT01966159|O1|Outcome|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
102447|NCT01966159|O2|Outcome|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
102448|NCT01966159|O1|Outcome|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
102449|NCT01966159|E2|Reported Event|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
102450|NCT01966159|E1|Reported Event|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
102451|NCT01966120|B3|Baseline|Total|Total of all reporting groups
102452|NCT01966120|B2|Baseline|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
102453|NCT01966120|B1|Baseline|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
102454|NCT01966120|P2|Participant Flow|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
102504|NCT01966003|O1|Outcome|ABP 215|Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
102505|NCT01966003|O2|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
102506|NCT01966003|O1|Outcome|ABP 215|Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
102455|NCT01966120|P1|Participant Flow|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the investigational medicinal product (IMP) was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
102456|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
102457|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
102458|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
102459|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
102460|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
102461|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
102462|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
102927|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102463|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
102464|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
102465|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
102466|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
102467|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
102468|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
102469|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
102470|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
102507|NCT01966003|E2|Reported Event|Bevacizumab|Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
102471|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
102472|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
102473|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
102474|NCT01966120|E2|Reported Event|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
102475|NCT01966120|E1|Reported Event|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
102476|NCT01966068|B3|Baseline|Total|Total of all reporting groups
102477|NCT01966068|B2|Baseline|MyAsthma Web Portal Adoption|Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys only once
102478|NCT01966068|B1|Baseline|MyAsthma Web Portal Sustained Use|Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys more than once
102479|NCT01966068|P1|Participant Flow|MyAsthma Web Portal|The portal, MyAsthma, provided asthma education, collected patient-reported outcomes, evaluated medication use and side effects, and tracked parents' concerns and goals. Parents logged into the web portal each month, and the information entered by parents was shared through the electronic health record with the child's primary care provider.
102480|NCT01966068|O2|Outcome|MyAsthma Portal Adoption|Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys only once.
102481|NCT01966068|O1|Outcome|MyAsthma Web Portal Sustained Use|Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys more than once
102482|NCT01966068|E1|Reported Event|MyAsthma Web Portal|"The portal, MyAsthma, will provide asthma education, collect patient-reported outcomes, evaluate medication use and side effects, and track parents' concerns and goals. Parents will log into the web portal each month, and the information entered by parents will be shared through the electronic health record with the child's primary care provider.~MyAsthma Web Portal"
102483|NCT01966042|B1|Baseline|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.~Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.~Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.~Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.~Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
102508|NCT01966003|E1|Reported Event|ABP 215|Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
102509|NCT01965938|B3|Baseline|Total|Total of all reporting groups
104117|NCT01958671|O2|Outcome|Ertugliflozin 15 mg|Participants received ertugliflozin 15 mg once daily for 26 weeks.
102484|NCT01966042|P1|Participant Flow|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and autologous bone marrow mononuclear cells infusion.~Local sedation: All subjects enrolled underwent local sedation for bone marrow aspiration.~Bone Marrow Aspiration: All subjects enrolled underwent bone marrow aspiration after anesthesia from the posterior iliac crest. The sample was aspirated into sterile syringes and brought to the cell processing laboratory. The processing was in accordance to the Standard Operating Procedure developed observing Good Practice Guidelines.~Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated.~Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened, the surgeon drew up the cells into syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
102485|NCT01966042|O1|Outcome|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.~Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.~Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.~Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.~Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
102486|NCT01966042|O1|Outcome|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.~Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.~Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.~Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.~Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
102487|NCT01966042|O1|Outcome|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.~Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.~Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.~Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.~Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
102488|NCT01966042|O1|Outcome|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.~Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.~Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.~Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.~Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
102489|NCT01966042|E1|Reported Event|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.~Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.~Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.~Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.~Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
102490|NCT01966003|B3|Baseline|Total|Total of all reporting groups
102491|NCT01966003|B2|Baseline|Bevacizumab|Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
102492|NCT01966003|B1|Baseline|ABP 215|Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
102493|NCT01966003|P2|Participant Flow|Bevacizumab|Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
102494|NCT01966003|P1|Participant Flow|ABP 215|Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
102495|NCT01966003|O2|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
102496|NCT01966003|O1|Outcome|ABP 215|Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
104118|NCT01958671|O1|Outcome|Ertugliflozin 5 mg|Participants received ertugliflozin 5 mg once daily for 26 weeks.
102510|NCT01965938|B2|Baseline|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
102511|NCT01965938|B1|Baseline|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
102512|NCT01965938|P2|Participant Flow|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
102513|NCT01965938|P1|Participant Flow|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
102514|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|"Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.~Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed."
102515|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|"Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.~RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed."
102516|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
102517|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
102518|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
102519|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
102520|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
102521|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
102522|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
102523|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
102524|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|"Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.~Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed."
102525|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|"Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.~RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed."
102526|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|"Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.~Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed."
102527|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|"Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.~RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed."
102528|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
102928|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102529|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
102530|NCT01965938|E2|Reported Event|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
102531|NCT01965938|E1|Reported Event|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
102532|NCT01965899|B1|Baseline|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
102533|NCT01965899|P1|Participant Flow|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
102534|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
102535|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
102536|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from the automatically detected arrhythmias. Documentation of episode occurrence will be retained.
102537|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
102538|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
102539|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
102540|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
102541|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
102542|NCT01965899|E1|Reported Event|Insertable Cardiac Monitor Implant|The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
102543|NCT01965834|B1|Baseline|Fenofibrate Therapy|"Fenofibrate orally daily for each 28 day cycle, per study protocol.~Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance < 50 mL/min will receive a reduced dose of 54 mg orally daily."
102544|NCT01965834|P1|Participant Flow|Fenofibrate Therapy|"Fenofibrate orally daily for each 28 day cycle, per study protocol.~Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance < 50 mL/min will receive a reduced dose of 54 mg orally daily."
102653|NCT01965561|P1|Participant Flow|Junctional Tourniquet Use|Junctional tourniquet use followed by rest, repeat. Rest = 5 minutes. SJT is belt with discs that inflate. JETT is belt with pads that screw down. AAT is a bladder within a belt. CRC is a vice.
102654|NCT01965561|O4|Outcome|SJT Tourniquet|SAM Junctional Tourniquet (SJT)
102545|NCT01965834|O1|Outcome|Fenofibrate Therapy|"Fenofibrate orally daily for each 28 day cycle, per study protocol.~Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance < 50 mL/min will receive a reduced dose of 54 mg orally daily."
102546|NCT01965834|O1|Outcome|Fenofibrate Therapy|"Fenofibrate orally daily for each 28 day cycle, per study protocol.~Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance < 50 mL/min will receive a reduced dose of 54 mg orally daily."
102547|NCT01965834|O1|Outcome|Fenofibrate Therapy|"Fenofibrate orally daily for each 28 day cycle, per study protocol.~Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance < 50 mL/min will receive a reduced dose of 54 mg orally daily."
102548|NCT01965834|E1|Reported Event|Fenofibrate Therapy|"Fenofibrate orally daily for each 28 day cycle, per study protocol.~Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance < 50 mL/min will receive a reduced dose of 54 mg orally daily."
102549|NCT01965756|B3|Baseline|Total|Total of all reporting groups
102550|NCT01965756|B2|Baseline|Placebo, Then Metformin|Participants first received placebo for 8 weeks. After 8 weeks, subjects were switched to metformin, according to the following dosing schedule: 500 mg by mouth daily for 1 week, then daily dose (in divided doses) increased by 500 mg per week until a maximum of 2000 mg/d (1000mg twice daily) was reached.
102551|NCT01965756|B1|Baseline|Metformin, Then Placebo|Participants first received metformin for 8 weeks, according to the following dosing schedule: 500 mg by mouth daily for 1 week, then daily dose (in divided doses) increased by 500 mg per week until a maximum of 2000 mg/d (1000mg twice daily) was reached. After 8 weeks, subjects were switched to matching placebo for an additional 8 weeks.
102552|NCT01965756|P2|Participant Flow|Placebo, Then Metformin (Treatment Sequence B, 0 to 16 Weeks)|Participants first received placebo for 8 weeks. After 8 weeks, subjects were switched to metformin, according to the following dosing schedule: 500 mg by mouth daily for 1 week, then daily dose (in divided doses) increased by 500 mg per week until a maximum of 2000 mg/d (1000mg twice daily) was reached.
102553|NCT01965756|P1|Participant Flow|Metformin, Then Placebo (Treatment Sequence A, 0 to 16 Weeks)|Participants first received metformin for 8 weeks, according to the following dosing schedule: 500 mg by mouth daily for 1 week, then daily dose (in divided doses) increased by 500 mg per week until a maximum of 2000 mg/d (1000mg twice daily) was reached. After 8 weeks, subjects were switched to matching placebo for an additional 8 weeks.
102554|NCT01965756|O2|Outcome|Placebo, Then Metformin|Participants first received placebo for 8 weeks. After 8 weeks, subjects were switched to metformin, according to the following dosing schedule: 500 mg by mouth daily for 1 week, then daily dose (in divided doses) increased by 500 mg per week until a maximum of 2000 mg/d (1000mg twice daily) was reached.
102555|NCT01965756|O1|Outcome|Metformin, Then Placebo|Participants first received metformin for 8 weeks, according to the following dosing schedule: 500 mg by mouth daily for 1 week, then daily dose (in divided doses) increased by 500 mg per week until a maximum of 2000 mg/d (1000mg twice daily) was reached. After 8 weeks, subjects were switched to matching placebo for an additional 8 weeks.
102556|NCT01965756|O2|Outcome|Placebo, Then Metformin|"Participants first received placebo for 8 weeks. After 8 weeks, subjects were switched to metformin, according to the following dosing schedule: 500 mg by mouth daily for 1 week, then daily dose (in divided doses) increased by 500 mg per week until a maximum of 2000 mg/d (1000mg twice daily) was reached.~Metformin~Placebos"
102557|NCT01965756|O1|Outcome|Metformin, Then Placebo|"Participants first received metformin for 8 weeks, according to the following dosing schedule: 500 mg by mouth daily for 1 week, then daily dose (in divided doses) increased by 500 mg per week until a maximum of 2000 mg/d (1000mg twice daily) was reached. After 8 weeks, subjects were switched to matching placebo for an additional 8 weeks.~Metformin~Placebos"
102558|NCT01965756|O2|Outcome|Placebo, Then Metformin|Participants first received placebo for 8 weeks. After 8 weeks, subjects were switched to metformin for 8 weeks, according to the following dosing schedule: 500 mg by mouth daily for 1 week, then daily dose (in divided doses) increased by 500 mg per week until a maximum of 2000 mg/d (1000mg twice daily) was reached.
102559|NCT01965756|O1|Outcome|Metformin, Then Placebo|Participants first received metformin for 8 weeks, according to the following dosing schedule: 500 mg by mouth daily for 1 week, then daily dose (in divided doses) increased by 500 mg per week until a maximum of 2000 mg/d (1000mg twice daily) was reached. After 8 weeks, subjects were switched to matching placebo for an additional 8 weeks.
102560|NCT01965756|O2|Outcome|Placebo, Then Metformin|Participants first received placebo for 8 weeks. After 8 weeks, subjects were switched to metformin for 8 weeks, according to the following dosing schedule: 500 mg by mouth daily for 1 week, then daily dose (in divided doses) increased by 500 mg per week until a maximum of 2000 mg/d (1000mg twice daily) was reached.
102561|NCT01965756|O1|Outcome|Metformin, Then Placebo|"Participants first received metformin for 8 weeks, according to the following dosing schedule: 500 mg by mouth daily for 1 week, then daily dose (in divided doses) increased by 500 mg per week until a maximum of 2000 mg/d (1000mg twice daily) was reached. After 8 weeks, subjects were switched to matching placebo for an additional 8 weeks.~Participants first received placebo for 8 weeks. After 8 weeks, subjects were switched to metformin, according to the following dosing schedule: 500 mg by mouth daily for 1 week, then daily dose (in divided doses) increased by 500 mg per week until a maximum of 2000 mg/d (1000mg twice daily) was reached."
102562|NCT01965756|O2|Outcome|Placebo, Then Metformin|Participants first received placebo for 8 weeks. After 8 weeks, subjects were switched to metformin for 8 weeks, according to the following dosing schedule: 500 mg by mouth daily for 1 week, then daily dose (in divided doses) increased by 500 mg per week until a maximum of 2000 mg/d (1000mg twice daily) was reached.
102655|NCT01965561|O3|Outcome|JETT|Use of Junctional Emergency Treatment Tool (JETT)
102563|NCT01965756|O1|Outcome|Metformin, Then Placebo|Participants first received metformin for 8 weeks, according to the following dosing schedule: 500 mg by mouth daily for 1 week, then daily dose (in divided doses) increased by 500 mg per week until a maximum of 2000 mg/d (1000mg twice daily) was reached. After 8 weeks, subjects were switched to matching placebo for an additional 8 weeks.
102564|NCT01965756|E2|Reported Event|Placebo|This group includes subjects treated with placebo for the first 8 weeks of the study, as well as subjects treated with placebo during the second 8 weeks of the study.
102565|NCT01965756|E1|Reported Event|Metformin|This group includes subjects treated with metformin for the first 8 weeks of the study, as well as subjects treated with metformin during the second 8 weeks of the study.
102566|NCT01965665|B1|Baseline|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.~MediHoney HCS dressing"
102567|NCT01965665|P1|Participant Flow|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.~MediHoney HCS dressing"
102568|NCT01965665|O1|Outcome|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.~MediHoney HCS dressing"
102569|NCT01965665|O1|Outcome|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.~MediHoney HCS dressing"
102570|NCT01965665|O1|Outcome|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.~MediHoney HCS dressing"
102571|NCT01965665|E1|Reported Event|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.~MediHoney HCS dressing"
102572|NCT01965652|B3|Baseline|Total|Total of all reporting groups
102573|NCT01965652|B2|Baseline|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
102574|NCT01965652|B1|Baseline|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
102575|NCT01965652|P2|Participant Flow|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
102576|NCT01965652|P1|Participant Flow|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
102577|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
102578|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
102579|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
102580|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
102581|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
102582|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
102583|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
102584|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
102585|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
102586|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
102587|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
102588|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
102589|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
102590|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
102591|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
102592|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
102593|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
102594|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
102595|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
102596|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
102597|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
102598|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
102599|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
102600|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
102601|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
102602|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
102603|NCT01965652|E2|Reported Event|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
102604|NCT01965652|E1|Reported Event|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
102605|NCT01965600|B1|Baseline|All Participants|Participants received PF-06282999 125 mg TID or 500 mg BID or matching placebo orally in tablet form from Days 1 to 3. On Day 3, participants received a dose of LPS as an IV bolus at a dose of 4 ng/kg over 45-60 secs 2 hours after the morning dose of PF-06282999 or matching placebo. A final dose of PF-06282999 or matching placebo was administered on the evening of Day 3. Period 2 started after a washout period of approximately 15 days with at least 21 days in between administration of LPS. Participants who took active treatment (PF-06282999) in Period 1 received placebo in Period 2 and vice versa.
102656|NCT01965561|O2|Outcome|AAJT|Use of Abdominal Aortic and Junctional Tourniquet (AAJT)
102606|NCT01965600|P4|Participant Flow|Placebo Followed by PF-06282999 500 mg BID|Participants received placebo orally via tablets. Placebo matching PF-06282999 500 mg BID were administered on Days 1-3 at 8am and 8pm. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3. Following a washout of about 15 days, participants returned for the second period where they received PF-06282999 500 mg BID in the same manner as placebo in the first period.
102607|NCT01965600|P3|Participant Flow|PF-06282999 500 mg BID Followed by Placebo|Participants received PF-06282999 500 milligrams (mg) twice daily (BID) orally in tablet form from Days 1 to 3 (8am and 8pm). On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3. After about 15 days of washout, participants returned for the second period where they received placebo in the same manner as active treatment before.
102608|NCT01965600|P2|Participant Flow|Placebo Followed by PF-06282999 125 mg TID|Participants received placebo orally via tablets. Placebo matching PF-06282999 125 mg TID were administered on Days 1-3 at approximately 8am, 2pm, and 8pm. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3. Following a washout of about 15 days, participants returned for the second period where they received PF-06282999 125 mg TID in the same manner as placebo in the first period.
102609|NCT01965600|P1|Participant Flow|PF-06282999 125 mg TID Followed by Placebo|Participants received PF-06282999 125 milligrams (mg) three times daily (TID) orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm). On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3. After about 15 days of washout, participants returned for the second period where they received placebo in the same manner as active treatment before.
102610|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
102611|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
102612|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
102613|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
102614|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
102615|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
102616|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
102617|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
102618|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
102619|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
102620|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
102621|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
102622|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
102623|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
102624|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
102625|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
102626|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
102627|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
102628|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
102629|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
102630|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
102631|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
102632|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
102633|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
102634|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
102635|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
102636|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
102637|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
102638|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
102639|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
102640|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
102641|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
102642|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
102643|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
102644|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
102645|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
102646|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
102647|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
102648|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
102649|NCT01965600|E3|Reported Event|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
102650|NCT01965600|E2|Reported Event|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
102651|NCT01965600|E1|Reported Event|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
102652|NCT01965561|B1|Baseline|Junctional Tourniquet Use|"Junctional tourniquet use followed by rest, repeat~Rest = 5 minutes. SJT is belt with discs that inflate. JETT is belt with pads that screw down. AAT is an bladder within a belt. CRC is a vice."
102657|NCT01965561|O1|Outcome|CRoC|Use of Combat Ready Clamp (CRoC)
102658|NCT01965561|O4|Outcome|SJT Tourniquet|SAM Junctional Tourniquet (SJT)
102664|NCT01965535|B2|Baseline|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
102665|NCT01965535|B1|Baseline|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
102666|NCT01965535|P2|Participant Flow|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
102667|NCT01965535|P1|Participant Flow|LDV/SOF|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily plus placebo to match ribavirin (RBV) in a divided daily dose for 24 weeks
102668|NCT01965535|O2|Outcome|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
102669|NCT01965535|O1|Outcome|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
102670|NCT01965535|O2|Outcome|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
102671|NCT01965535|O1|Outcome|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
102672|NCT01965535|O2|Outcome|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
102673|NCT01965535|O1|Outcome|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
102674|NCT01965535|O2|Outcome|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
102675|NCT01965535|O1|Outcome|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
102676|NCT01965535|O2|Outcome|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
102677|NCT01965535|O1|Outcome|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
102678|NCT01965535|E2|Reported Event|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
102679|NCT01965535|E1|Reported Event|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
102680|NCT01965431|B1|Baseline|Overall Study|This study is randomised, single-blind, 3-period crossover having 3 treatments, BI 207127 and Faldaprevir for 3 days (Days -2 to 1), placebo to BI 207127 plus placebo to Faldaprevir for 3 days (Days -2 to 1) and Moxifloxacin 400 mg as single dose (Day 1).
102681|NCT01965431|P6|Participant Flow|R2/R1/T|Patients were treated in the morning with oral dose, started in period 1 with Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water, followed in period 2 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, and in period 3 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
102682|NCT01965431|P5|Participant Flow|R2/T/R1|Patients were treated in the morning with oral dose, started in period 1 with Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered on as single dose on day 1 with 240 mL of water, followed in period 2 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water, and in period 3 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
102683|NCT01965431|P4|Participant Flow|R1/R2/T|Patients were treated in the morning with oral dose, started in period 1 with matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, followed in period 2 by Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water, and in period 3 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
103068|NCT01964716|B3|Baseline|Total|Total of all reporting groups
102684|NCT01965431|P3|Participant Flow|R1/T/R2|Patients were treated with oral dose, started in period 1 with matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, followed in period 2 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water, and in period 3 by Moxifloxacin (R2):Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
102685|NCT01965431|P2|Participant Flow|T/R2/R1|Patients were treated with oral dose, started in period 1 with BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water, followed in period 2 by Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water, and in period 3 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
102686|NCT01965431|P1|Participant Flow|T/R1/R2|Patients were treated with oral dose, started in period 1 with BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) twice daily (bid) were administered on day -2 and day -1 and 600 mg once daily (qd) on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg once daily (qd) on day -1 and day 1 with 240 mL of water, followed in period 2 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, and in period 3 by Moxifloxacin (R2) : Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
102687|NCT01965431|O2|Outcome|Placebo to BI 207127 + Placebo to Faldaprevir|Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
102688|NCT01965431|O1|Outcome|BI 207127 + Faldaprevir|Orally administered BI 207127 film coated tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
102689|NCT01965431|O2|Outcome|Placebo to BI 207127) + Placebo to Faldaprevir|Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
102690|NCT01965431|O1|Outcome|BI 207127 + Faldaprevir|Orally administered BI 207127 film coated tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
102691|NCT01965431|O2|Outcome|Placebo to BI 207127 + Placebo to Faldaprevir|Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
102692|NCT01965431|O1|Outcome|Moxifloxacin|Orally administered Moxifloxacin film coated tablet 400 mg as single dose on day 1 with 240 mL of water.
102693|NCT01965431|O2|Outcome|Placebo to BI 207127 + Placebo to Faldaprevir|Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
102694|NCT01965431|O1|Outcome|BI 207127+ Faldaprevir|Orally administered BI 207127 film coated tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
102695|NCT01965431|E3|Reported Event|Placebo (BI 207127) + Placebo (Faldaprevir)|Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and 1 with 240 mL of water.
102696|NCT01965431|E2|Reported Event|Moxifloxacin|Orally administered Moxifloxacin film coated tablet 400 mg as single dose on day1 with 240 mL of water.
102697|NCT01965431|E1|Reported Event|BI 207127 + Faldaprevir|Orally administered BI 207127 film coated tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and 1 with 240 mL of water.
102698|NCT01965327|B1|Baseline|Interferon Gamma-1b (ACTIMMUNE)|All individuals in this study were treated with interferon gamma-1b (ACTIMMUNE). Doses were administered via subcutaneous injections three times per week for 12 weeks. Dose-escalation schedule was completed by all subjects as follows: For the first two weeks subjects took10 mcg/m2 of interferon gamma-1b (IFN-g-1b), then the dose was escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study, finally, the dose was escalated to 50 mcg/m2 of IFN-gamma-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
102699|NCT01965327|P1|Participant Flow|Interferon Gamma-1b (ACTIMMUNE)|All individuals in this study were treated with interferon gamma-1b (ACTIMMUNE). Doses were administered via subcutaneous injections three times per week for 12 weeks. Dose-escalation schedule was completed by all subjects as follows: For the first two weeks subjects took10 mcg/m2 of interferon gamma-1b (IFN-g-1b), then the dose was escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study, finally, the dose was escalated to 50 mcg/m2 of IFN-gamma-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
103367|NCT01963260|O2|Outcome|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
102700|NCT01965327|O1|Outcome|Interferon Gamma-1b (ACTIMMUNE)|All individuals in this study were treated with interferon gamma-1b (ACTIMMUNE). Doses were administered via subcutaneous injections three times per week for 12 weeks. Dose-escalation schedule was completed by all subjects as follows: For the first two weeks subjects took10 mcg/m2 of interferon gamma-1b (IFN-g-1b), then the dose was escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study, finally, the dose was escalated to 50 mcg/m2 of IFN-gamma-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
102701|NCT01965327|O1|Outcome|Interferon Gamma-1b (ACTIMMUNE)|All individuals in this study were treated with interferon gamma-1b (ACTIMMUNE). Doses were administered via subcutaneous injections three times per week for 12 weeks. Dose-escalation schedule was completed by all subjects as follows: For the first two weeks subjects took10 mcg/m2 of interferon gamma-1b (IFN-g-1b), then the dose was escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study, finally, the dose was escalated to 50 mcg/m2 of IFN-gamma-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
102702|NCT01965327|E1|Reported Event|Interferon Gamma-1b (ACTIMMUNE)|All individuals in this study were treated with interferon gamma-1b (ACTIMMUNE). Doses were administered via subcutaneous injections three times per week for 12 weeks. Dose-escalation schedule was completed by all subjects as follows: For the first two weeks subjects took10 mcg/m2 of interferon gamma-1b (IFN-g-1b), then the dose was escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study, finally, the dose was escalated to 50 mcg/m2 of IFN-gamma-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
102703|NCT01965288|B3|Baseline|Total|Total of all reporting groups
102704|NCT01965288|B2|Baseline|Lotrafilcon B Then Comfilcon A|All subjects attended first visit with habitual lenses and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102705|NCT01965288|B1|Baseline|Comfilcon A Then Lotrafilcon B|All subjects attended first visit with habitual lenses and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102706|NCT01965288|P2|Participant Flow|Lotrafilcon B Then Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102707|NCT01965288|P1|Participant Flow|Comfilcon A Then Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102708|NCT01965288|O3|Outcome|Neither|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102709|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102710|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102711|NCT01965288|O3|Outcome|Habitual|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102712|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102713|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102714|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102715|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102716|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102717|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102718|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102719|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102720|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
103413|NCT01963143|E1|Reported Event|Gammaplex 5% - All Subjects|Subjects aged 17-55 years
103414|NCT01963091|B3|Baseline|Total|Total of all reporting groups
102721|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102722|NCT01965288|O2|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102723|NCT01965288|O1|Outcome|Habitual Lenses|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102724|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102725|NCT01965288|O1|Outcome|Habitual Lenses|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102726|NCT01965288|O2|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102727|NCT01965288|O1|Outcome|Habitual Lenses|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102728|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102729|NCT01965288|O1|Outcome|Habitual Lenses|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102730|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102731|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102732|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102733|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102734|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects with habitual lens prior to dispense of study lens.
102735|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102736|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102737|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102738|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102739|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102740|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102741|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102742|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102743|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102744|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
103431|NCT01962974|O1|Outcome|Golimumab|Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
102745|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102746|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102747|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects with habitual lens prior to dispense of study lens.
102748|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102749|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102750|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102751|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102752|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects with habitual lens prior to dispense of study lens.
102753|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102754|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102755|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102756|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102757|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects with habitual lens prior to dispense of study lens.
102758|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102759|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102760|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102761|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102762|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects with habitual lens prior to dispense of study lens.
102763|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102764|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102765|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102766|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102767|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102768|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102769|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102770|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102771|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102772|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102773|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102774|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102775|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102776|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102777|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102778|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102779|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102780|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102781|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102782|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102783|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102784|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102785|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102786|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102787|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102788|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102789|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102790|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102791|NCT01965288|O2|Outcome|Lotrafilcon B|Each subject randomized to wear comfilcon A or lotrafilcon B for one month of daily wear before repeating the schedule for the second pair without a washout period. All subjects wore both lenses. (comfilcon A then lotrafilcon B and/or lotrafilcon B then comfilcon A)
102792|NCT01965288|O1|Outcome|Comfilcon A|Each subject randomized to wear comfilcon A or lotrafilcon B for one month of daily wear before repeating the schedule for the second pair without a washout period. All subjects wore both lenses. (comfilcon A then lotrafilcon B and/or lotrafilcon B then comfilcon A)
102793|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102794|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102795|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102796|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102797|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102798|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102799|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102800|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102801|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102802|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102803|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102804|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102805|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102806|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102807|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102808|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102809|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102810|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102811|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102812|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102813|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102814|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102815|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102816|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.)
102817|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102818|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102819|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102820|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102821|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102822|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102823|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102824|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102825|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102826|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102827|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102828|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102829|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102830|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102831|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102832|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102833|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102834|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102835|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102836|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102837|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102838|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.A)
102839|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102840|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102841|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102842|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102843|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102844|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102845|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102846|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102847|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102848|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102849|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102850|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.A)
102851|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102852|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102853|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.)
102854|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102855|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102856|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102857|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102858|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102859|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102860|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102861|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102862|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102863|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102864|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102865|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102866|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102867|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102868|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102869|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102870|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102871|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102872|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102873|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102874|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102875|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102876|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102877|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102878|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102879|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102880|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102881|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102882|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102883|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102884|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102885|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102886|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102887|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102888|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102889|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102890|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102891|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102892|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102893|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102894|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102895|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102896|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102897|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
102898|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
102899|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
102900|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
102901|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
102902|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
102903|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
102904|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
102905|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
102906|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
102907|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
102908|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects after removal of habitual lens and prior to dispense of study lens.
102909|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
102910|NCT01965288|E2|Reported Event|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.)
102911|NCT01965288|E1|Reported Event|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
102912|NCT01965262|B1|Baseline|Overall Baseline Characteristics|"Randomized to wear the Hema-copolymer lens pair or the etafilcon A lens pair for one week then cross over to the alternate pair~Hema-copolymer Lens: Hema-copolymer lens pair or the Etafilcon A lens pair~etafilcon A Lens: Hema-copolymer lens pair or the Etafilcon A lens pair"
102913|NCT01965262|P2|Participant Flow|Etafilcon A Lens, Then Hema-copoloymer Lens|Participants were randomized to wear the etafilcon A lens pair for one week then cross over to the Hema-copolymer lens lens pair.
102914|NCT01965262|P1|Participant Flow|Hema-copolymer Lens, Then Etafilcon A Lens|Participants were randomized to wear the Hema-copolymer lens pair for one week then cross over to the etafilcon A lens pair.
102915|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102916|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102917|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102918|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102919|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102920|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102921|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102922|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102923|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102924|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102925|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102926|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102929|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102930|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102931|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102932|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102933|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102934|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102935|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102936|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102937|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102938|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102939|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102940|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102941|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102942|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102943|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102944|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102945|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102946|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102947|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102948|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102949|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102950|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102951|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102952|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102953|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102954|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102955|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102956|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102957|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102958|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102959|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102960|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102961|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102962|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102963|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102964|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102965|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
104119|NCT01958671|O3|Outcome|Placebo|Participants received placebo to ertugliflozin once daily for 26 weeks.
102966|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102967|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102968|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102969|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102970|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102971|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102972|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102973|NCT01965262|E2|Reported Event|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
102974|NCT01965262|E1|Reported Event|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
102975|NCT01965158|B3|Baseline|Total|Total of all reporting groups
102976|NCT01965158|B2|Baseline|Placebo|Participants received placebo orally once daily for 12 weeks.
102977|NCT01965158|B1|Baseline|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
102978|NCT01965158|P2|Participant Flow|Placebo|Participants received placebo orally once daily for 12 weeks.
102979|NCT01965158|P1|Participant Flow|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
102980|NCT01965158|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
102981|NCT01965158|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
102982|NCT01965158|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
102983|NCT01965158|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
102984|NCT01965158|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
102985|NCT01965158|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
102986|NCT01965158|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
102987|NCT01965158|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
102988|NCT01965158|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
102989|NCT01965158|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
102990|NCT01965158|E2|Reported Event|Placebo|Participants received placebo orally once daily for 12 weeks.
102991|NCT01965158|E1|Reported Event|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
102992|NCT01965067|B3|Baseline|Total|Total of all reporting groups
102993|NCT01965067|B2|Baseline|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
102994|NCT01965067|B1|Baseline|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
102995|NCT01965067|P2|Participant Flow|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
102996|NCT01965067|P1|Participant Flow|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
102997|NCT01965067|O2|Outcome|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
102998|NCT01965067|O1|Outcome|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
102999|NCT01965067|O2|Outcome|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
103000|NCT01965067|O1|Outcome|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
103001|NCT01965067|O2|Outcome|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
103002|NCT01965067|O1|Outcome|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
103003|NCT01965067|O2|Outcome|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
103004|NCT01965067|O1|Outcome|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
107187|NCT01946243|O2|Outcome|VisQ|Quantitation as an adjunct to qualitative scan interpretation
103005|NCT01965067|O2|Outcome|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
103006|NCT01965067|O1|Outcome|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
103007|NCT01965067|O2|Outcome|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
103008|NCT01965067|O1|Outcome|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
103009|NCT01965067|E2|Reported Event|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
103010|NCT01965067|E1|Reported Event|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
103011|NCT01965002|B1|Baseline|MRgHIFU|The InSightec ExAblate 2000 MRgHIFU system is a non-invasive device that is fully integrated with an MR imaging system and used for the ablation of soft tissue. The treatment process begins with the physician acquiring a set of MR images, identifying one or more target volume(s) of fibroid tissue to be ablated, and drawing the treatment contours. The therapy planning software computes the type and number of sonications required to treat the defined volume while minimizing total treatment time. MR images taken during the sonication provide a diagnostic quality image of the target tissue and a quantitative, real-time temperature map overlay to confirm the therapeutic effect of the treatment. The transducer is then automatically moved to the succeeding treatment point and the process is repeated until the entire volume has been treated. Approximately 100 individual sonications can be delivered over a 3-hour period to complete a treatment.
103012|NCT01965002|P1|Participant Flow|MRgHIFU|The InSightec ExAblate 2000 magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system is a non-invasive device that is fully integrated with an MR imaging system and used for the ablation of soft tissue. The treatment process begins with the physician acquiring a set of MR images, identifying 1+ target volume(s) of fibroid tissue to be ablated, and drawing the treatment contours. The therapy planning software computes the type and number of sonications required to treat the defined volume while minimizing total treatment time. MR images taken during the sonication provide a diagnostic quality image of the target tissue and a quantitative, real-time temperature map overlay to confirm the therapeutic effect of the treatment. The transducer is then automatically moved to the succeeding treatment point and the process is repeated until the entire volume has been treated. About 100 individual sonications can be delivered over a 3-hour period to complete a treatment.
103013|NCT01965002|O1|Outcome|MRgHIFU|The InSightec ExAblate 2000 MRgHIFU system is a non-invasive thermal ablation device fully integrated with an MR imaging system being used for the ablation of tumor tissue.
103014|NCT01965002|O1|Outcome|MRgHIFU|In the resected tumor specimen, the volume of the ablated area will be determined by obtaining a digital photograph of each pathology slice. The region of interest corresponding to the ablated area will be traced, and the ablated area will be calculated for each slice and summed. Accuracy is assessed as the percent ablated volume relative to pre-treatment tumor volume.
103015|NCT01965002|O1|Outcome|MRgHIFU|The InSightec ExAblate 2000 MRgHIFU system is a non-invasive thermal ablation device fully integrated with an MR imaging system being used for the ablation of tumor tissue
103016|NCT01965002|E1|Reported Event|MRgHIFU|The InSightec ExAblate 2000 MRgHIFU system is a non-invasive thermal ablation device fully integrated with an MR imaging system being used for the ablation of tumor tissue
103017|NCT01964976|B3|Baseline|Total|Total of all reporting groups
103018|NCT01964976|B2|Baseline|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
103019|NCT01964976|B1|Baseline|Alogliptin + Biguanides|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
103020|NCT01964976|P1|Participant Flow|All Population|All participants who received alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months along with biguanide or without biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
103021|NCT01964976|O1|Outcome|Alogliptin|Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
103022|NCT01964976|O1|Outcome|Alogliptin|Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
103023|NCT01964976|O1|Outcome|Alogliptin|Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
103024|NCT01964976|O1|Outcome|Alogliptin|Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
103025|NCT01964976|O2|Outcome|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
103026|NCT01964976|O1|Outcome|Alogliptin + Biguanides|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
103432|NCT01962974|E1|Reported Event|Golimumab|Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
103027|NCT01964976|O2|Outcome|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
103028|NCT01964976|O1|Outcome|Alogliptin + Biguanides|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
103029|NCT01964976|E2|Reported Event|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
103030|NCT01964976|E1|Reported Event|Alogliptin + Biguanides|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
103031|NCT01964950|B3|Baseline|Total|Total of all reporting groups
103032|NCT01964950|B2|Baseline|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
103033|NCT01964950|B1|Baseline|Alogliptin + SU|Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
103034|NCT01964950|P1|Participant Flow|All Population (Alogliptin)|All participants who received alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months along with an SU or without an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
103035|NCT01964950|O1|Outcome|Alogliptin|Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
103036|NCT01964950|O1|Outcome|Alogliptin|Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
103037|NCT01964950|O1|Outcome|Alogliptin|Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
103038|NCT01964950|O1|Outcome|Alogliptin|Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
103039|NCT01964950|O2|Outcome|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
103040|NCT01964950|O1|Outcome|Alogliptin + SU|Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
103041|NCT01964950|O2|Outcome|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
103042|NCT01964950|O1|Outcome|Alogliptin + SU|Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
103043|NCT01964950|E2|Reported Event|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
103044|NCT01964950|E1|Reported Event|Alogliptin + SU|Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
103045|NCT01964898|B3|Baseline|Total|Total of all reporting groups
103046|NCT01964898|B2|Baseline|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
103047|NCT01964898|B1|Baseline|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
103069|NCT01964716|B2|Baseline|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
103070|NCT01964716|B1|Baseline|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
103048|NCT01964898|P2|Participant Flow|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
103049|NCT01964898|P1|Participant Flow|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
103050|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
103051|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
103052|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
103053|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
103054|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
103055|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
103056|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
103057|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
103058|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
103059|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
103060|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
103061|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
103062|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
103063|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
103064|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
103065|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
103066|NCT01964898|E2|Reported Event|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
103067|NCT01964898|E1|Reported Event|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
103071|NCT01964716|P2|Participant Flow|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
103072|NCT01964716|P1|Participant Flow|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
103073|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
103074|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
103075|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
103076|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
103077|NCT01964716|O3|Outcome|Screened Only|Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
103078|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
103079|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
103080|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
103081|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
103082|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
103083|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
103084|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
103085|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
103086|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
103087|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
103088|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
103089|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
103090|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
103091|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
103092|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
103093|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
103094|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
103095|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
103096|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
103097|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
103098|NCT01964716|E9|Reported Event|Screened Only|Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
103211|NCT01963845|P2|Participant Flow|Active Drug|Sitagliptin 100 mg
103212|NCT01963845|P1|Participant Flow|Placebo|Sitagliptin-matched placebo tablet
103099|NCT01964716|E8|Reported Event|13vPnC SDS: After Dose 3|Participants who received all three 0.5mL doses of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 3 and up to blood draw at 4 weeks.
103100|NCT01964716|E7|Reported Event|13vPnC MDV: After Dose 3|Participants who received all three 0.5mL doses of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 3 and up to blood draw at 4 weeks.
103101|NCT01964716|E6|Reported Event|13vPnC SDS: After Dose 2|Participants who received two 0.5 mL doses of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg 8, 12 weeks of age, assessed after Dose 2 and before Dose 3.
103102|NCT01964716|E5|Reported Event|13vPnC MDV: After Dose 2|Participants who received two 0.5 mL doses of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg 8, 12 weeks of age, assessed after Dose 2 and before Dose 3.
103103|NCT01964716|E4|Reported Event|13vPnC SDS: After Dose 1|Participants who received single 0.5 mL dose of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 1 and before Dose 2.
103104|NCT01964716|E3|Reported Event|13vPnC MDV: After Dose 1|Participants who received single 0.5 mL dose of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 1 and before Dose 2.
103105|NCT01964716|E2|Reported Event|13vPnC SDS: Informed Consent to Dose 1|Participants who were randomized to receive 13vPnC (PF-05208760) SDS at 8, 12, and 16 weeks of age, assessed between signing of informed consent and before Dose 1.
103106|NCT01964716|E1|Reported Event|13vPnC MDV: Informed Consent to Dose 1|Participants who were randomized to receive 13vPnC (PF-06414256) MDV at 8, 12, and 16 weeks of age, assessed between signing of informed consent and before Dose 1.
103107|NCT01964547|B3|Baseline|Total|Total of all reporting groups
103108|NCT01964547|B2|Baseline|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
103109|NCT01964547|B1|Baseline|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
103110|NCT01964547|P2|Participant Flow|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
103111|NCT01964547|P1|Participant Flow|Sativex|Each 100 μl actuation contains delta-9-tetrahydrocannabinol (THC) (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
103112|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
103113|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
103114|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
103115|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
103116|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
103117|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
103118|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
103119|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
103120|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
103121|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
103122|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
103123|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
103124|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
103125|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
103126|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
103127|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
103128|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
103129|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
103130|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
103131|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
103132|NCT01964547|E2|Reported Event|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
103213|NCT01963845|O2|Outcome|Active Drug|"Sitagliptin 100 mg~Sitagliptin"
103133|NCT01964547|E1|Reported Event|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
103134|NCT01964352|B5|Baseline|Total|Total of all reporting groups
103135|NCT01964352|B4|Baseline|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
103136|NCT01964352|B3|Baseline|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
103137|NCT01964352|B2|Baseline|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
103138|NCT01964352|B1|Baseline|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
103139|NCT01964352|P4|Participant Flow|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
103140|NCT01964352|P3|Participant Flow|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
103141|NCT01964352|P2|Participant Flow|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
103142|NCT01964352|P1|Participant Flow|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
103143|NCT01964352|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
103144|NCT01964352|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
103145|NCT01964352|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
103146|NCT01964352|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
103147|NCT01964352|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
103148|NCT01964352|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
103149|NCT01964352|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
103150|NCT01964352|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
103151|NCT01964352|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
103152|NCT01964352|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
103153|NCT01964352|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
103154|NCT01964352|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
103155|NCT01964352|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
103156|NCT01964352|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
103157|NCT01964352|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
103158|NCT01964352|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
103159|NCT01964352|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
103160|NCT01964352|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
103161|NCT01964352|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
103162|NCT01964352|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
103163|NCT01964352|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
103164|NCT01964352|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
103165|NCT01964352|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
103166|NCT01964352|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
103167|NCT01964352|E4|Reported Event|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
103168|NCT01964352|E3|Reported Event|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
103169|NCT01964352|E2|Reported Event|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
103170|NCT01964352|E1|Reported Event|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
103171|NCT01964326|B1|Baseline|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
103172|NCT01964326|P1|Participant Flow|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
103173|NCT01964326|O1|Outcome|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
103174|NCT01964326|O1|Outcome|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
103175|NCT01964326|O1|Outcome|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
103176|NCT01964326|O1|Outcome|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
103214|NCT01963845|O1|Outcome|Placebo|Sitagliptin-matched placebo tablet
103215|NCT01963845|O2|Outcome|Active Drug|"Sitagliptin 100 mg~Sitagliptin"
103177|NCT01964326|E1|Reported Event|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
103178|NCT01964222|B3|Baseline|Total|Total of all reporting groups
103179|NCT01964222|B2|Baseline|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
103180|NCT01964222|B1|Baseline|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
103181|NCT01964222|P2|Participant Flow|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
103182|NCT01964222|P1|Participant Flow|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
103183|NCT01964222|O2|Outcome|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
103184|NCT01964222|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
103185|NCT01964222|O2|Outcome|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
103186|NCT01964222|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
103187|NCT01964222|O2|Outcome|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
103188|NCT01964222|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
103189|NCT01964222|O2|Outcome|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
103190|NCT01964222|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
103191|NCT01964222|O2|Outcome|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
103192|NCT01964222|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
103193|NCT01964222|E2|Reported Event|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
103194|NCT01964222|E1|Reported Event|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
103195|NCT01964105|B4|Baseline|Total|Total of all reporting groups
103196|NCT01964105|B3|Baseline|Non-Randomized Cohort: 3D Imaging|Since enrollment in the non-randomized arm was predicated upon a pre-existing desire for computer simulation, all of these patients received this intervention.
103197|NCT01964105|B2|Baseline|Standard Preoperative Evaluation|The control group underwent tissue-based planning that was supplemented by review of photos obtained from magazines or the internet, and placement of sizers in a surgical bra. Control group patients underwent three-dimensional photography with the same system but were not simulated.
103198|NCT01964105|B1|Baseline|3D Imaging Simulation|The intervention group underwent computer simulation with the Vectra Sculptor package (Canfield Scientific Inc, Parsippany, NJ) in addition to control group preoperative evaluation.
103199|NCT01964105|P3|Participant Flow|3D Imaging Simulation|"Intervention Group: 3D Image Simulation + Standard Preoperative Evaluation Goal: 50 patients~3D Imaging"
103200|NCT01964105|P2|Participant Flow|Non-Randomized Cohort: 3D Imaging|"Patients who refuse the option of randomization but otherwise meet the inclusion and exclusion criteria will be offered participation in this study as part of a non-randomized cohort.~Goal: 50 Patients~3D Imaging"
103201|NCT01964105|P1|Participant Flow|Standard Preoperative Evaluation|"Control Group: Patients will receive standard preoperative evaluation (2D imaging).~Goal: 50 patients"
103202|NCT01964105|O3|Outcome|Non-Randomized Cohort: 3D Imaging|"Patients who refuse the option of randomization but otherwise meet the inclusion and exclusion criteria will be offered participation in this study as part of a non-randomized cohort.~Goal: 50 Patients~3D Imaging"
103203|NCT01964105|O2|Outcome|3D Imaging Simulation|"Control Group: Patients will receive standard preoperative evaluation (2D imaging).~Goal: 50 patients"
103204|NCT01964105|O1|Outcome|Standard Preoperative Evaluation|"Intervention Group: 3D Image Simulation + Standard Preoperative Evaluation Goal: 50 patients~3D Imaging"
103205|NCT01964105|E3|Reported Event|Non-Randomized Cohort: 3D Imaging|Patient undergo three-dimensional simulation of their breast augmentation. They sought this intervention (ie. not randomized).
103206|NCT01964105|E2|Reported Event|3D Imaging Simulation|Patient undergo three-dimensional simulation of their breast augmentation. They were randomized to this intervention.
103207|NCT01964105|E1|Reported Event|Standard Preoperative Evaluation|Patients undergo standard tissue-based planning. They were randomized to this intervention.
103208|NCT01963845|B3|Baseline|Total|Total of all reporting groups
103209|NCT01963845|B2|Baseline|Active Drug|Sitagliptin 100 mg
103210|NCT01963845|B1|Baseline|Placebo|Sitagliptin-matched placebo tablet
103227|NCT01963767|B1|Baseline|NT-020|"Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening.~NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent."
103228|NCT01963767|P2|Participant Flow|Placebo|Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
103229|NCT01963767|P1|Participant Flow|NT-020|"Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening.~NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent."
103230|NCT01963767|O2|Outcome|Placebo|Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
103231|NCT01963767|O1|Outcome|NT-020|"Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening.~NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent.~Scientific description of the ingredients of the product per a 2 capsule dose Vitamin D3 (as cholecalciferol) – 2000 IU BioVin® Grape Extract – 40 mg Proprietary Blend – 900mg Green Tea Extract (Camellia sinensis) Wild Blueberries* (whole fruit) Carnosine VitaBlue® Wild Blueberry Extract*~Vaccinium angustifolium"
103232|NCT01963767|O2|Outcome|Placebo|Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
103233|NCT01963767|O1|Outcome|NT-020|"Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening.~NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent.~Scientific description of the ingredients of the product per a 2 capsule dose Vitamin D3 (as cholecalciferol) – 2000 IU BioVin® Grape Extract – 40 mg Proprietary Blend – 900mg Green Tea Extract (Camellia sinensis) Wild Blueberries* (whole fruit) Carnosine VitaBlue® Wild Blueberry Extract*~Vaccinium angustifolium"
103234|NCT01963767|E2|Reported Event|Placebo|Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
103235|NCT01963767|E1|Reported Event|NT-020|"Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening.~NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent.~Scientific description of the ingredients of the product per a 2 capsule dose Vitamin D3 (as cholecalciferol) – 2000 IU BioVin® Grape Extract – 40 mg Proprietary Blend – 900mg Green Tea Extract (Camellia sinensis) Wild Blueberries* (whole fruit) Carnosine VitaBlue® Wild Blueberry Extract*~Vaccinium angustifolium"
103236|NCT01963676|B3|Baseline|Total|Total of all reporting groups
103237|NCT01963676|B2|Baseline|Sham Stimulation|"13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.~Sham stimulation"
103238|NCT01963676|B1|Baseline|Transcranial Direct Current Stimulation (tDCS)|"13 subjects total. 2mA stimulation for 20 minutes.~tDCS"
103239|NCT01963676|P2|Participant Flow|Sham Stimulation|"13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.~Sham stimulation"
103240|NCT01963676|P1|Participant Flow|Transcranial Direct Current Stimulation (tDCS)|"13 subjects total. 2mA stimulation for 20 minutes.~tDCS"
103241|NCT01963676|O2|Outcome|Sham Stimulation|"13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.~Sham stimulation"
103242|NCT01963676|O1|Outcome|Transcranial Direct Current Stimulation (tDCS)|"13 subjects total. 2mA stimulation for 20 minutes.~tDCS"
103243|NCT01963676|O2|Outcome|Sham Stimulation|"13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.~Sham stimulation"
103244|NCT01963676|O1|Outcome|Transcranial Direct Current Stimulation (tDCS)|"13 subjects total. 2mA stimulation for 20 minutes.~tDCS"
103245|NCT01963676|E2|Reported Event|Sham Stimulation|"13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.~Sham stimulation"
103246|NCT01963676|E1|Reported Event|Transcranial Direct Current Stimulation (tDCS)|"13 subjects total. 2mA stimulation for 20 minutes.~tDCS"
103247|NCT01963611|B6|Baseline|Total|Total of all reporting groups
103248|NCT01963611|B5|Baseline|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
103249|NCT01963611|B4|Baseline|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
103250|NCT01963611|B3|Baseline|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103251|NCT01963611|B2|Baseline|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103252|NCT01963611|B1|Baseline|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103253|NCT01963611|P5|Participant Flow|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
103254|NCT01963611|P4|Participant Flow|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
103255|NCT01963611|P3|Participant Flow|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103256|NCT01963611|P2|Participant Flow|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103257|NCT01963611|P1|Participant Flow|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103258|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
103259|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
103260|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103261|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103262|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103263|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
103264|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
103265|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103266|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103267|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103268|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
103269|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
103270|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103271|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103272|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103273|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months
103274|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
103275|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103276|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103277|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103278|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
103279|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
103280|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103281|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103282|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103283|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
103284|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
103285|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103286|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103287|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103288|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
103289|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
103290|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103433|NCT01962961|B4|Baseline|Total|Total of all reporting groups
103291|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103292|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103293|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
103294|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
103295|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103296|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103297|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103298|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
103299|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
103300|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103301|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103302|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103303|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
103304|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
103305|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103306|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103307|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
103308|NCT01963611|E5|Reported Event|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for a minimum of 40 weeks.
103309|NCT01963611|E4|Reported Event|Plovamer Acetate 20 mg|Plovamer acetate was administered at a dose of 20 mg as weekly subcutaneous injection for a minimum of 40 weeks.
103310|NCT01963611|E3|Reported Event|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for a minimum of 40 weeks.
103311|NCT01963611|E2|Reported Event|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for a minimum of 40 weeks.
103312|NCT01963611|E1|Reported Event|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for a minimum of 40 weeks.
103313|NCT01963403|B3|Baseline|Total|Total of all reporting groups
103314|NCT01963403|B2|Baseline|Placebo|"Placebo~Placebo: 1 pill per day; daily during study participation (up to 84 days)"
103315|NCT01963403|B1|Baseline|EE 30mcg/LNG 150mcg|"combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)~EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)"
103316|NCT01963403|P2|Participant Flow|Placebo|"Placebo~Placebo: 1 pill per day; daily during study participation (up to 84 days)"
103317|NCT01963403|P1|Participant Flow|EE 30mcg/LNG 150mcg|"combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)~EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)"
103318|NCT01963403|O2|Outcome|No Use of COC at Any Time During 3 Months|
103319|NCT01963403|O1|Outcome|Used COC at Any Time During 3 Months|
103320|NCT01963403|O2|Outcome|Placebo|"Placebo~Placebo: 1 pill per day; daily during study participation (up to 84 days)"
103321|NCT01963403|O1|Outcome|EE 30mcg/LNG 150mcg|"combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)~EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)"
103322|NCT01963403|O2|Outcome|Placebo|"Placebo~Placebo: 1 pill per day; daily during study participation (up to 84 days)"
103323|NCT01963403|O1|Outcome|EE 30mcg/LNG 150mcg|"combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)~EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)"
103324|NCT01963403|O2|Outcome|Placebo|"Placebo~Placebo: 1 pill per day; daily during study participation (up to 84 days)"
103325|NCT01963403|O1|Outcome|EE 30mcg/LNG 150mcg|"combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)~EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)"
103326|NCT01963403|E2|Reported Event|Placebo|Placebo: 1 pill per day; daily during study participation (up to 84 days)
103327|NCT01963403|E1|Reported Event|EE 30mcg/LNG 150mcg|"Combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)~EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)"
103328|NCT01963260|B11|Baseline|Total|Total of all reporting groups
103329|NCT01963260|B10|Baseline|Part 2: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
103330|NCT01963260|B9|Baseline|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
103331|NCT01963260|B8|Baseline|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
103332|NCT01963260|B7|Baseline|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
103333|NCT01963260|B6|Baseline|Part 1: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
103334|NCT01963260|B5|Baseline|Part 1: MK-8723 100 mg/kg in Healthy Participants|MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103335|NCT01963260|B4|Baseline|Part 1: MK-8723 30 mg/kg in Healthy Participants|MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103336|NCT01963260|B3|Baseline|Part 1: MK-8723 10 mg/kg in Healthy Participants|MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103337|NCT01963260|B2|Baseline|Part 1: MK-8723 3 mg/kg in Healthy Participants|MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103338|NCT01963260|B1|Baseline|Part 1: MK-8723 1 mg/kg in Healthy Participants|MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103339|NCT01963260|P10|Participant Flow|Part 2: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
103340|NCT01963260|P9|Participant Flow|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants with ITP from Part 2 MK-8723 10 mg/kg were re-enrolled into Part 2 100 mg/kg and dosed (not shown).
103341|NCT01963260|P8|Participant Flow|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
103342|NCT01963260|P7|Participant Flow|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with immune thrombocytopenia purpura (ITP) in Part 2. 2 participants were subsequently enrolled in Part 2 MK-8723 100 mg/kg.
103343|NCT01963260|P6|Participant Flow|Part 1: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
103344|NCT01963260|P5|Participant Flow|Part 1: MK-8723 100 mg/kg in Healthy Participants|MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103345|NCT01963260|P4|Participant Flow|Part 1: MK-8723 30 mg/kg in Healthy Participants|MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103346|NCT01963260|P3|Participant Flow|Part 1: MK-8723 10 mg/kg in Healthy Participants|MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103347|NCT01963260|P2|Participant Flow|Part 1: MK-8723 3 mg/kg in Healthy Participants|MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103348|NCT01963260|P1|Participant Flow|Part 1: MK-8723 1 mg/kg in Healthy Participants|MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103349|NCT01963260|O8|Outcome|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
103350|NCT01963260|O7|Outcome|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
103351|NCT01963260|O6|Outcome|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
103352|NCT01963260|O5|Outcome|Part 1: MK-8723 100 mg/kg in Healthy Participants|MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103353|NCT01963260|O4|Outcome|Part 1: MK-8723 30 mg/kg in Healthy Participants|MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103354|NCT01963260|O3|Outcome|Part 1: MK-8723 10 mg/kg in Healthy Participants|MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103355|NCT01963260|O2|Outcome|Part 1: MK-8723 3 mg/kg in Healthy Participants|MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103356|NCT01963260|O1|Outcome|Part 1: MK-8723 1 mg/kg in Healthy Participants|MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103357|NCT01963260|O8|Outcome|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
103358|NCT01963260|O7|Outcome|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
103359|NCT01963260|O6|Outcome|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
103360|NCT01963260|O5|Outcome|Part 1: MK-8723 100 mg/kg in Healthy Participants|MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103361|NCT01963260|O4|Outcome|Part 1: MK-8723 30 mg/kg in Healthy Participants|MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103362|NCT01963260|O3|Outcome|Part 1: MK-8723 10 mg/kg in Healthy Participants|MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103363|NCT01963260|O2|Outcome|Part 1: MK-8723 3 mg/kg in Healthy Participants|MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103364|NCT01963260|O1|Outcome|Part 1: MK-8723 1 mg/kg in Healthy Participants|MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103365|NCT01963260|O4|Outcome|Part 2: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
103366|NCT01963260|O3|Outcome|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
103368|NCT01963260|O1|Outcome|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
103369|NCT01963260|O10|Outcome|Part 2: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
103370|NCT01963260|O9|Outcome|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
103371|NCT01963260|O8|Outcome|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
103372|NCT01963260|O7|Outcome|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
103373|NCT01963260|O6|Outcome|Part 1: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
103374|NCT01963260|O5|Outcome|Part 1: MK-8723 100 mg/kg in Healthy Participants|MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103375|NCT01963260|O4|Outcome|Part 1: MK-8723 30 mg/kg in Healthy Participants|MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103376|NCT01963260|O3|Outcome|Part 1: MK-8723 10 mg/kg in Healthy Participants|MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103377|NCT01963260|O2|Outcome|Part 1: MK-8723 3 mg/kg in Healthy Participants|MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103378|NCT01963260|O1|Outcome|Part 1: MK-8723 1 mg/kg in Healthy Participants|MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103379|NCT01963260|O10|Outcome|Part 2: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
103380|NCT01963260|O9|Outcome|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
103381|NCT01963260|O8|Outcome|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
103382|NCT01963260|O7|Outcome|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
103383|NCT01963260|O6|Outcome|Part 1: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
103384|NCT01963260|O5|Outcome|Part 1: MK-8723 100 mg/kg in Healthy Participants|MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103385|NCT01963260|O4|Outcome|Part 1: MK-8723 30 mg/kg in Healthy Participants|MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103386|NCT01963260|O3|Outcome|Part 1: MK-8723 10 mg/kg in Healthy Participants|MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103387|NCT01963260|O2|Outcome|Part 1: MK-8723 3 mg/kg in Healthy Participants|MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103388|NCT01963260|O1|Outcome|Part 1: MK-8723 1 mg/kg in Healthy Participants|MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103389|NCT01963260|E10|Reported Event|Part 2: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
103390|NCT01963260|E9|Reported Event|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
103391|NCT01963260|E8|Reported Event|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
103392|NCT01963260|E7|Reported Event|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
103393|NCT01963260|E6|Reported Event|Part 1: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
103394|NCT01963260|E5|Reported Event|Part 1: MK-8723 100 mg/kg in Healthy Participants|MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103395|NCT01963260|E4|Reported Event|Part 1: MK-8723 30 mg/kg in Healthy Participants|MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103396|NCT01963260|E3|Reported Event|Part 1: MK-8723 10 mg/kg in Healthy Participants|MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103397|NCT01963260|E2|Reported Event|Part 1: MK-8723 3 mg/kg in Healthy Participants|MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103398|NCT01963260|E1|Reported Event|Part 1: MK-8723 1 mg/kg in Healthy Participants|MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
103399|NCT01963143|B4|Baseline|Total|Total of all reporting groups
103400|NCT01963143|B3|Baseline|Pediatrics|Gammaplex 10 on a 21 or 28 day schedule
103401|NCT01963143|B2|Baseline|Treatment Sequence 2 - Adults|Gammaplex 5% and Gammaplex 10 on a 28-day schedule
103402|NCT01963143|B1|Baseline|Treatment Sequence 1 - Adults|Gammaplex 5% and Gammaplex 10 on a 21-day schedule
103403|NCT01963143|P3|Participant Flow|Pediatrics|Gammaplex 10 on a 21 or 28 day treatment schedule
103404|NCT01963143|P2|Participant Flow|Treatment Sequence 2 - Adults|Gammaplex 10 and Gammaplex 5% on a 28-day treatment schedule
103405|NCT01963143|P1|Participant Flow|Treatment Sequence 1 - Adults|Gammaplex 5% & Gammaplex 10 on a 21-day treatment schedule
103406|NCT01963143|O2|Outcome|Gammaplex 5%|
103407|NCT01963143|O1|Outcome|Gammaplex 10%|
103408|NCT01963143|O2|Outcome|Gammaplex 5%|
103409|NCT01963143|O1|Outcome|Gammaplex 10%|
103410|NCT01963143|O2|Outcome|Gammaplex 5%|
103411|NCT01963143|O1|Outcome|Gammaplex 10%|
103412|NCT01963143|E2|Reported Event|Gammaplex 10% - All Subjects|Subjects aged 2-55 years
103415|NCT01963091|B2|Baseline|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
103416|NCT01963091|B1|Baseline|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
103417|NCT01963091|P2|Participant Flow|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
103418|NCT01963091|P1|Participant Flow|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
103419|NCT01963091|O2|Outcome|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
103420|NCT01963091|O1|Outcome|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
103421|NCT01963091|O2|Outcome|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
103422|NCT01963091|O1|Outcome|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
103423|NCT01963091|O2|Outcome|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
103424|NCT01963091|O1|Outcome|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
103425|NCT01963091|E2|Reported Event|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
103426|NCT01963091|E1|Reported Event|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
103427|NCT01962974|B1|Baseline|Golimumab|Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
103428|NCT01962974|P1|Participant Flow|Golimumab|Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
103429|NCT01962974|O1|Outcome|Golimumab|Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
103430|NCT01962974|O1|Outcome|Golimumab|Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
103434|NCT01962961|B3|Baseline|Placebo|"Matching placebo pills given twice daily for 8 weeks~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
103435|NCT01962961|B2|Baseline|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
103436|NCT01962961|B1|Baseline|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
103437|NCT01962961|P3|Participant Flow|Placebo|"Matching placebo pills given twice daily for 8 weeks~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
103438|NCT01962961|P2|Participant Flow|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
103439|NCT01962961|P1|Participant Flow|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
103440|NCT01962961|O3|Outcome|Placebo|"Matching placebo pills given twice daily for 8 weeks~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
103441|NCT01962961|O2|Outcome|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
103442|NCT01962961|O1|Outcome|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
103443|NCT01962961|O3|Outcome|Placebo|"Matching placebo pills given twice daily for 8 weeks~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
103444|NCT01962961|O2|Outcome|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
103473|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
103474|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
103475|NCT01962922|E2|Reported Event|Tacrolimus - IR|brand IR tacrolimus
103476|NCT01962922|E1|Reported Event|Envarsus XR|Tacrolimus extended release
103477|NCT01962675|B3|Baseline|Total|Total of all reporting groups
104120|NCT01958671|O2|Outcome|Ertugliflozin 15 mg|Participants received ertugliflozin 15 mg once daily for 26 weeks
103445|NCT01962961|O1|Outcome|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
103446|NCT01962961|O3|Outcome|Placebo|"Matching placebo pills given twice daily for 8 weeks~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
103447|NCT01962961|O2|Outcome|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
103448|NCT01962961|O1|Outcome|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
103449|NCT01962961|E3|Reported Event|Placebo|"Matching placebo pills given twice daily for 8 weeks~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
103450|NCT01962961|E2|Reported Event|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
103451|NCT01962961|E1|Reported Event|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
103452|NCT01962922|B3|Baseline|Total|Total of all reporting groups
103453|NCT01962922|B2|Baseline|Sequence II|Sequence II Envarsus XR→IR-Tac (N = 23)
103454|NCT01962922|B1|Baseline|Sequence I|Sequence I IR-Tac→Envarsus XR (N = 27)
103455|NCT01962922|P2|Participant Flow|Sequence 2|"• Sequence II: (n=23) 1 Patients receive Envarsus XR tablets (at 15% lower dose than their IR-Tac dose) on Days 1–7 (24-hour PK profile on Day 7), then patients are switched back to twice-daily Tac - IR treatment beginning on Day 8. PK on days 14 and 21.~Patients in sequence 2 are on Tac - IR at Day 21. Patient have option of continuing in extension portion of the study on Tac - IR for up to 6 months."
103456|NCT01962922|P1|Participant Flow|Sequence 1|"•Sequence I: (n=27) Patients will continue on twice-daily IR-Tac capsules on Days 1–7 (24-hour PK profile on Day 7), then patients are switched to Envarsus XR tablets (at a dose 15% lower than their Tac - IR doses) on Day 8. PK on day 14 and 21.~Patients in sequence 1 are on Envarsus XR at Day 21. Patient may continue on extension up to a total of 6 months."
103457|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
103458|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
103459|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
103460|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
103461|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
103462|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
103463|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
103464|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
103465|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
103466|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
103467|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
103468|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
103469|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
103470|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
103471|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
103472|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
103478|NCT01962675|B2|Baseline|Sham tDCS - Real tDCS|"Sham tDCS+skilled training~Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles~Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles"
103479|NCT01962675|B1|Baseline|Real tDCS - Sham tDCS|"Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles~Sham tDCS+skilled training Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles"
103480|NCT01962675|P2|Participant Flow|Sham tDCS - Real tDCS|"Sham tDCS+skilled training~Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles~Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles"
103481|NCT01962675|P1|Participant Flow|Real tDCS - Sham tDCS|"Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles~Sham tDCS+skilled training Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles"
103482|NCT01962675|O2|Outcome|Sham tDCS - Real tDCS|"Sham tDCS+skilled training~Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles~Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles"
103483|NCT01962675|O1|Outcome|Real tDCS - Sham tDCS|"Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles~Sham tDCS+skilled training Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles"
103484|NCT01962675|O2|Outcome|Sham tDCS - Real tDCS|"Sham tDCS+skilled training~Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles~Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles"
103485|NCT01962675|O1|Outcome|Real tDCS - Sham tDCS|"Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles~Sham tDCS+skilled training Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles"
103486|NCT01962675|O2|Outcome|Sham tDCS and Skilled Leg Training|"Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
103487|NCT01962675|O1|Outcome|tDCS and Skilled Training|"tDCS and skilled leg training. Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
103488|NCT01962675|O2|Outcome|Sham tDCS and Skilled Leg Training|"Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
103545|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
103489|NCT01962675|O1|Outcome|tDCS and Skilled Training|"tDCS and skilled leg training. Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
103490|NCT01962675|E2|Reported Event|Sham tDCS and Skilled Leg Training|"Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
103491|NCT01962675|E1|Reported Event|tDCS and Skilled Training|"tDCS and skilled leg training. Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
103492|NCT01962558|B3|Baseline|Total|Total of all reporting groups
103493|NCT01962558|B2|Baseline|VNS Control|"Vagus nerve stimulation and tones are given daily over a 2.5 hour period, but not in the same way as the experimental group, and in such a way that it is believed to be ineffective but still provide both VNS and tones so that blinding is maintained.~VNS Control: This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective."
103494|NCT01962558|B1|Baseline|VNS Treatment|"Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.~VNS Treatment: VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS."
103495|NCT01962558|P2|Participant Flow|VNS Control|"Vagus nerve stimulation and tones are given daily over a 2.5 hour period, but not in the same way as the experimental group, and in such a way that it is believed to be ineffective but still provide both VNS and tones so that blinding is maintained.~VNS Control: This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective."
103496|NCT01962558|P1|Participant Flow|VNS Treatment|"Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.~VNS Treatment: VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS."
103497|NCT01962558|O2|Outcome|VNS Control|"Vagus nerve stimulation and tones are given daily over a 2.5 hour period, but not in the same way as the experimental group, and in such a way that it is believed to be ineffective but still provide both VNS and tones so that blinding is maintained.~VNS Control: This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective."
103498|NCT01962558|O1|Outcome|VNS Treatment|"Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.~VNS Treatment: VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS."
103499|NCT01962558|O2|Outcome|VNS Control|"Vagus nerve stimulation and tones are given daily over a 2.5 hour period, but not in the same way as the experimental group, and in such a way that it is believed to be ineffective but still provide both VNS and tones so that blinding is maintained.~VNS Control: This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective."
103500|NCT01962558|O1|Outcome|VNS Treatment|"Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.~VNS Treatment: VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS."
103501|NCT01962558|O2|Outcome|VNS Control|"Vagus nerve stimulation and tones are given daily over a 2.5 hour period, but not in the same way as the experimental group, and in such a way that it is believed to be ineffective but still provide both VNS and tones so that blinding is maintained.~VNS Control: This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective."
103502|NCT01962558|O1|Outcome|VNS Treatment|"Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.~VNS Treatment: VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS."
103503|NCT01962558|O2|Outcome|VNS Control|"Vagus nerve stimulation and tones are given daily over a 2.5 hour period, but not in the same way as the experimental group, and in such a way that it is believed to be ineffective but still provide both VNS and tones so that blinding is maintained.~VNS Control: This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective."
103504|NCT01962558|O1|Outcome|VNS Treatment|"Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.~VNS Treatment: VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS."
103505|NCT01962558|O2|Outcome|VNS Control|"Vagus nerve stimulation and tones are given daily over a 2.5 hour period, but not in the same way as the experimental group, and in such a way that it is believed to be ineffective but still provide both VNS and tones so that blinding is maintained.~VNS Control: This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective."
103506|NCT01962558|O1|Outcome|VNS Treatment|"Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.~VNS Treatment: VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS."
103507|NCT01962558|O2|Outcome|VNS Control|"Vagus nerve stimulation and tones are given daily over a 2.5 hour period, but not in the same way as the experimental group, and in such a way that it is believed to be ineffective but still provide both VNS and tones so that blinding is maintained.~VNS Control: This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective."
103546|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
103508|NCT01962558|O1|Outcome|VNS Treatment|"Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.~VNS Treatment: VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS."
103509|NCT01962558|E2|Reported Event|VNS Control|"Vagus nerve stimulation and tones are given daily over a 2.5 hour period, but not in the same way as the experimental group, and in such a way that it is believed to be ineffective but still provide both VNS and tones so that blinding is maintained.~VNS Control: This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective."
103510|NCT01962558|E1|Reported Event|VNS Treatment|"Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.~VNS Treatment: VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS."
103511|NCT01962493|B3|Baseline|Total|Total of all reporting groups
103512|NCT01962493|B2|Baseline|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
103513|NCT01962493|B1|Baseline|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
103514|NCT01962493|P2|Participant Flow|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
103515|NCT01962493|P1|Participant Flow|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
103516|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
103517|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
103518|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
103519|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
103520|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
103521|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
103522|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
103523|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
103524|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
103525|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
103526|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
103527|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
103528|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
103529|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
103530|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
103531|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
103532|NCT01962493|E2|Reported Event|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
103533|NCT01962493|E1|Reported Event|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
103534|NCT01962441|B4|Baseline|Total|Total of all reporting groups
103535|NCT01962441|B3|Baseline|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
103536|NCT01962441|B2|Baseline|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
103537|NCT01962441|B1|Baseline|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
103538|NCT01962441|P3|Participant Flow|SOF+RBV+Peg-IFN 12 Weeks|"Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly for 12 weeks~Participants in this group were not eligible to enroll into the Retreatment Period."
103539|NCT01962441|P2|Participant Flow|SOF+RBV 24 Weeks, Then Retreatment|"Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks~Retreatment Period: Participants who experienced virologic failure during treatment or relapsed at or before Posttreatment Week 24 during the Randomized Period were eligible to enroll into the Retreatment Period to receive SOF+Peg-IFN+RBV for 12 weeks."
103540|NCT01962441|P1|Participant Flow|SOF+RBV 16 Weeks, Then Retreatment|"Randomized Period: Sofosbuvir (Sovaldi®; SOF) 400 mg tablet administered orally once daily + ribavirin (RBV) tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks~Retreatment Period: Participants who experienced virologic failure during treatment or relapsed at or before Posttreatment Week 24 during the Randomized Period were eligible to enroll into the Retreatment Period to receive SOF+Peg-IFN+RBV for 12 weeks."
103541|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
103542|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
103543|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
103544|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
107188|NCT01946243|O1|Outcome|Qualitative|Qualitative scan interpretation only
103547|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
103548|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
103549|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
103550|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
103551|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
103552|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
103553|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
103554|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
103555|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
103556|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
103557|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
103558|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
103559|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
103560|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
103561|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
103562|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
103563|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
103564|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
103565|NCT01962441|E4|Reported Event|Retreatment Period: SOF+RBV+Peg-IFN 12 Weeks|Retreatment Period: Participants from the SOF+RBV 16 Weeks or 24 Weeks groups who experienced virologic failure during treatment or relapsed at or before Posttreatment Week 24 during the Randomized Period were eligible to enroll into the Retreatment Period to receive SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks.
103566|NCT01962441|E3|Reported Event|Randomized Period: SOF+RBV+Peg-IFN 12 Weeks|Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
103567|NCT01962441|E2|Reported Event|Randomized Period: SOF+RBV 24 Weeks|Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
103568|NCT01962441|E1|Reported Event|Randomized Period: SOF+RBV 16 Weeks|Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
103569|NCT01962428|B3|Baseline|Total|Total of all reporting groups
103570|NCT01962428|B2|Baseline|Conventional Loading Dose of Ticagrelor|"Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
103571|NCT01962428|B1|Baseline|High Loading Dose of Ticagrelor|"Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
103572|NCT01962428|P2|Participant Flow|Conventional Loading Dose of Ticagrelor|"Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
103573|NCT01962428|P1|Participant Flow|High Loading Dose of Ticagrelor|"Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
103574|NCT01962428|O2|Outcome|High Loading Dose of Ticagrelor|"Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
103575|NCT01962428|O1|Outcome|Conventional Loading Dose of Ticagrelor|"Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
107222|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
103576|NCT01962428|E2|Reported Event|High Loading Dose of Ticagrelor|"Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
103577|NCT01962428|E1|Reported Event|Conventional Loading Dose of Ticagrelor|"Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
103578|NCT01961544|B1|Baseline|Eribulin Mesylate 1.4 mg/m^2|Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
103579|NCT01961544|P1|Participant Flow|Eribulin Mesylate 1.4 mg/m^2|Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
103580|NCT01961544|O1|Outcome|Eribulin Mesylate 1.4 mg/m^2|Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
103581|NCT01961544|O1|Outcome|Eribulin Mesylate 1.4 mg/m^2|Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
103582|NCT01961544|E1|Reported Event|Eribulin Mesylate 1.4 mg/m^2|Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2-5 minutes on Day 1 and Day 8 of each 21-day cycle.
103583|NCT01961349|B4|Baseline|Total|Total of all reporting groups
103584|NCT01961349|B3|Baseline|ICI35,868 With EES0000645/A|ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
103585|NCT01961349|B2|Baseline|ICI35,868 Without EES0000645/A|ICI35,868 administered by the anaesthesiologist without EES0000645/A
103586|NCT01961349|B1|Baseline|Placebo|Placebo administered by the anaesthesiologist without EES0000645/A
103587|NCT01961349|P3|Participant Flow|ICI35,868 With EES0000645/A|ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
103588|NCT01961349|P2|Participant Flow|ICI35,868 Without EES0000645/A|ICI35,868 administered by the anaesthesiologist without EES0000645/A
103589|NCT01961349|P1|Participant Flow|Placebo|Placebo administered by the anaesthesiologist without EES0000645/A
103590|NCT01961349|O3|Outcome|ICI35,868 With EES0000645/A|ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
103591|NCT01961349|O2|Outcome|ICI35,868 Without EES0000645/A|ICI35,868 administered by the anaesthesiologist without EES0000645/A
103592|NCT01961349|O1|Outcome|Placebo|Placebo administered by the anaesthesiologist without EES0000645/A
103593|NCT01961349|O3|Outcome|ICI35,868 With EES0000645/A|ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
103594|NCT01961349|O2|Outcome|ICI35,868 Without EES0000645/A|ICI35,868 administered by the anaesthesiologist without EES0000645/A
103595|NCT01961349|O1|Outcome|Placebo|Placebo administered by the anaesthesiologist without EES0000645/A
103596|NCT01961349|E3|Reported Event|ICI35,868 With EES0000645/A|ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
103597|NCT01961349|E2|Reported Event|ICI35,868 Without EES0000645/A|ICI35,868 administered by the anaesthesiologist without EES0000645/A
103598|NCT01961349|E1|Reported Event|Placebo|Placebo administered by the anaesthesiologist without EES0000645/A
103599|NCT01961323|B1|Baseline|Nebivolol|"Nebivolol 5 mg (titrated to a maximal dose of 10mg for optimal blood pressure) for 6 months~Nebivolol: Doses titrated based on weekly visits during the first 2 weeks to achieve a target SBP<140 and DBP <90 mm Hg. If BP remains uncontrolled after 2 weeks of treatment, indapamide will be added at a dosage of 2.5 mg/day. If the therapeutic goal is still not achieved by 4 weeks, patients will be withdrawn from the study.Upward titration will be halted, and the previous dosage level resumed, if at any point systolic blood pressure falls to ≤ 100 mmHg, even if the individual remains asymptomatic."
103600|NCT01961323|P1|Participant Flow|Nebivolol|"Nebivolol 5 mg (titrated to a maximal dose of 10mg for optimal blood pressure) for 6 months~Nebivolol: Doses titrated based on weekly visits during the first 2 weeks to achieve a target SBP<140 and DBP <90 mm Hg. If BP remains uncontrolled after 2 weeks of treatment, indapamide will be added at a dosage of 2.5 mg/day. If the therapeutic goal is still not achieved by 4 weeks, patients will be withdrawn from the study.Upward titration will be halted, and the previous dosage level resumed, if at any point systolic blood pressure falls to ≤ 100 mmHg, even if the individual remains asymptomatic."
103601|NCT01961323|O1|Outcome|Nebivolol|"Nebivolol 5 mg (titrated to a maximal dose of 10mg for optimal blood pressure) for 6 months~Nebivolol: Doses titrated based on weekly visits during the first 2 weeks to achieve a target SBP<140 and DBP <90 mm Hg. If BP remains uncontrolled after 2 weeks of treatment, indapamide will be added at a dosage of 2.5 mg/day. If the therapeutic goal is still not achieved by 4 weeks, patients will be withdrawn from the study.Upward titration will be halted, and the previous dosage level resumed, if at any point systolic blood pressure falls to ≤ 100 mmHg, even if the individual remains asymptomatic."
103602|NCT01961323|O1|Outcome|Nebivolol|"Nebivolol 5 mg (titrated to a maximal dose of 10mg for optimal blood pressure) for 6 months~Nebivolol: Doses titrated based on weekly visits during the first 2 weeks to achieve a target SBP<140 and DBP <90 mm Hg. If BP remains uncontrolled after 2 weeks of treatment, indapamide will be added at a dosage of 2.5 mg/day. If the therapeutic goal is still not achieved by 4 weeks, patients will be withdrawn from the study.Upward titration will be halted, and the previous dosage level resumed, if at any point systolic blood pressure falls to ≤ 100 mmHg, even if the individual remains asymptomatic."
103603|NCT01961323|O1|Outcome|Nebivolol|"Nebivolol 5 mg (titrated to a maximal dose of 10mg for optimal blood pressure) for 6 months~Nebivolol: Doses titrated based on weekly visits during the first 2 weeks to achieve a target SBP<140 and DBP <90 mm Hg. If BP remains uncontrolled after 2 weeks of treatment, indapamide will be added at a dosage of 2.5 mg/day. If the therapeutic goal is still not achieved by 4 weeks, patients will be withdrawn from the study.Upward titration will be halted, and the previous dosage level resumed, if at any point systolic blood pressure falls to ≤ 100 mmHg, even if the individual remains asymptomatic."
103737|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
103604|NCT01961323|E1|Reported Event|Nebivolol|"Nebivolol 5 mg (titrated to a maximal dose of 10mg for optimal blood pressure) for 6 months~Nebivolol: Doses titrated based on weekly visits during the first 2 weeks to achieve a target SBP<140 and DBP <90 mm Hg. If BP remains uncontrolled after 2 weeks of treatment, indapamide will be added at a dosage of 2.5 mg/day. If the therapeutic goal is still not achieved by 4 weeks, patients will be withdrawn from the study.Upward titration will be halted, and the previous dosage level resumed, if at any point systolic blood pressure falls to ≤ 100 mmHg, even if the individual remains asymptomatic."
103605|NCT01961297|B3|Baseline|Total|Total of all reporting groups
103606|NCT01961297|B2|Baseline|Spasmodic Dysphonia/Voice Tremor|Participants with Spasmodic Dysphonia/Voice Tremor (SD/VT) given oral administration of a single dose of sodium oxybate (1.0-1.5 gm)
103607|NCT01961297|B1|Baseline|Spasmodic Dysphonia|Participants with Spasmodic Dysphonia (SD) given oral administration of a single dose of sodium oxybate (1.0-1.5 gm)
103608|NCT01961297|P2|Participant Flow|Spasmodic Dysphonia/Voice Tremor|Participants with Spasmodic Dysphonia/Voice Tremor (SD/VT) given oral administration of a single dose of sodium oxybate (1.0-1.5 gm)
103609|NCT01961297|P1|Participant Flow|Spasmodic Dysphonia|Participants with Spasmodic Dysphonia (SD) given oral administration of a single dose of sodium oxybate (1.0-1.5 gm)
103610|NCT01961297|O2|Outcome|Spasmodic Dysphonia/Voice Tremor|Participants with Spasmodic Dysphonia/Voice Tremor (SD/VT) given oral administration of a single dose of sodium oxybate (1.0-1.5 gm)
103611|NCT01961297|O1|Outcome|Spasmodic Dysphonia|Participants with Spasmodic Dysphonia (SD) given oral administration of a single dose of sodium oxybate (1.0-1.5 gm)
103612|NCT01961297|O2|Outcome|Spasmodic Dysphonia/Voice Tremor|Participants with Spasmodic Dysphonia/Voice Tremor (SD/VT) given oral administration of a single dose of sodium oxybate (1.0-1.5 gm)
103613|NCT01961297|O1|Outcome|Spasmodic Dysphonia|Participants with Spasmodic Dysphonia (SD) given oral administration of a single dose of sodium oxybate (1.0-1.5 gm)
103614|NCT01961297|O2|Outcome|Spasmodic Dysphonia/Voice Tremor|Participants with Spasmodic Dysphonia/Voice Tremor (SD/VT) given oral administration of a single dose of sodium oxybate (1.0-1.5 gm)
103615|NCT01961297|O1|Outcome|Spasmodic Dysphonia|Participants with Spasmodic Dysphonia (SD) given oral administration of a single dose of sodium oxybate (1.0-1.5 gm)
103616|NCT01961297|O2|Outcome|Spasmodic Dysphonia/Voice Tremor|Participants with Spasmodic Dysphonia/Voice Tremor (SD/VT) given oral administration of a single dose of sodium oxybate (1.0-1.5 gm)
103617|NCT01961297|O1|Outcome|Spasmodic Dysphonia|Participants with Spasmodic Dysphonia (SD) given oral administration of a single dose of sodium oxybate (1.0-1.5 gm)
103618|NCT01961297|O2|Outcome|Spasmodic Dysphonia/Voice Tremor|Participants with Spasmodic Dysphonia/Voice Tremor (SD/VT) given oral administration of a single dose of sodium oxybate (1.0-1.5 gm)
103619|NCT01961297|O1|Outcome|Spasmodic Dysphonia|Participants with Spasmodic Dysphonia (SD) given oral administration of a single dose of sodium oxybate (1.0-1.5 gm)
103620|NCT01961297|E2|Reported Event|Spasmodic Dysphonia/Voice Tremor|Participants with Spasmodic Dysphonia/Voice Tremor (SD/VT) given oral administration of a single dose of sodium oxybate (1.0-1.5 gm)
103621|NCT01961297|E1|Reported Event|Spasmodic Dysphonia|Participants with Spasmodic Dysphonia (SD) given oral administration of a single dose of sodium oxybate (1.0-1.5 gm)
103622|NCT01961271|B1|Baseline|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
103623|NCT01961271|P1|Participant Flow|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
103624|NCT01961271|O1|Outcome|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
103625|NCT01961271|O1|Outcome|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
103626|NCT01961271|O1|Outcome|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
103627|NCT01961271|O1|Outcome|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
103628|NCT01961271|O1|Outcome|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
103629|NCT01961271|O1|Outcome|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
103630|NCT01961271|E1|Reported Event|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
103631|NCT01961115|B4|Baseline|Total|Total of all reporting groups
103632|NCT01961115|B3|Baseline|All Other Patients|All advanced melanoma patients not previously treated with anti-PD-1 & anti-PD-L1 who meet protocol entry criteria INCB024360 - 300 mg po bid continuous for 98 days MELITAC 12.1 - Intradermal/subcutaneous Days 21, 28, 35, 56, 77, 98
103633|NCT01961115|B2|Baseline|Cohort B|"Pts.enrolled 2-6 wks after failing anti-PD-1/PDL-1~INCB024360 - 100 mg po bid continuous for 98 days~MELITAC 12.1 - Intradermal/subcutaneous Days 21, 28, 35, 56, 77, 98"
104121|NCT01958671|O1|Outcome|Ertugliflozin 5 mg|Participants received ertugliflozin 5 mg once daily for 26 weeks.
103634|NCT01961115|B1|Baseline|Cohort A|Pts. enrolled >6 wks after failing anti-PD-1/PDL-1 INCB024360 - 300 mg po bid continuous for 98 days MELITAC 12.1 - Intradermal/subcutaneous Days 21, 28, 35, 56, 77, 98
103635|NCT01961115|P3|Participant Flow|All Other Patients|"All advanced melanoma patients not previously treated with anti-PD-1 & anti-PD-L1 who meet protocol entry criteria~Pts. will receive 300 mg INCB024360 po bid for 98 days + MELITAC 12. 1 vaccine on days 21, 28, 35, 56, 77 & 98"
103636|NCT01961115|P2|Participant Flow|Cohort B|Pts. enrolled 2-6 wks after failing anti-PD-1/PDL-1 received 300 mg INCB024360 po BID every day for 98 days Cohort B - Pts. enrolled 2-6 weeks after failing anti-PD-1/PDL-1 received 100 mg INCB024360 po BID every day for 98 days
103637|NCT01961115|P1|Participant Flow|Cohort A|"Cohort A - Pts. enrolled >6 wks after failing anti-PD-1/PDL-1 received 300 mg INCB024360 po BID every day for 98 days Cohort B - Pts. enrolled 2-6 weeks after failing anti-PD-1/PDL-1 received 100 mg INCB024360 po BID every day for 98 days All other pts. - received 300 mg po BID~All pts received MELITAC 12.1 intradermal/subcutaneous on days 21, 28, 35, 56, 77, 98"
103638|NCT01961115|O3|Outcome|All Other Patients|"All advanced melanoma patients not previously treated with anti-PD-1 & anti-PD-L1 who meet protocol entry criteria~Pts. will receive 300 mg INCB024360 po bid for 98 days + MELITAC 12. 1 vaccine on days 21, 28, 35, 56, 77 & 98"
103639|NCT01961115|O2|Outcome|Cohort B|"Pts.enrolled 2-6 wks after failing anti-PD-1/PDL-1~Pts. receive 100 mg po bid INCB024360 continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 & 98"
103640|NCT01961115|O1|Outcome|Cohort A|"Pts.enrolled >6 wks after failing anti-PD-1/PDL-1~Pts will receive 300mg INCB024360 p.o. bid continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 & 98"
103641|NCT01961115|O3|Outcome|All Other Patients|"All advanced melanoma patients not previously treated with anti-PD-1 & anti-PD-L1 who meet protocol entry criteria~Pts. will receive 300 mg INCB024360 po bid for 98 days + MELITAC 12. 1 vaccine on days 21, 28, 35, 56, 77 & 98"
103642|NCT01961115|O2|Outcome|Cohort B|"Pts.enrolled 2-6 wks after failing anti-PD-1/PDL-1~Pts. receive 100 mg po bid INCB024360 continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 & 98"
103643|NCT01961115|O1|Outcome|Cohort A|"Pts.enrolled >6 wks after failing anti-PD-1/PDL-1~Pts will receive 300mg INCB024360 p.o. bid continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 & 98"
103644|NCT01961115|O3|Outcome|All Other Patients|"All advanced melanoma patients not previously treated with anti-PD-1 & anti-PD-L1 who meet protocol entry criteria~Pts. will receive 300 mg INCB024360 po bid for 98 days + MELITAC 12. 1 vaccine on days 21, 28, 35, 56, 77 & 98"
103645|NCT01961115|O2|Outcome|Cohort B|"Pts.enrolled 2-6 wks after failing anti-PD-1/PDL-1~Pts. receive 100 mg po bid INCB024360 continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 & 98"
103646|NCT01961115|O1|Outcome|Cohort A|"Pts.enrolled >6 wks after failing anti-PD-1/PDL-1~Pts will receive 300mg INCB024360 p.o. bid continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 & 98"
103647|NCT01961115|O3|Outcome|All Other Patients|"All advanced melanoma patients not previously treated with anti-PD-1 & anti-PD-L1 who meet protocol entry criteria~Pts. will receive 300 mg INCB024360 po bid for 98 days + MELITAC 12. 1 vaccine on days 21, 28, 35, 56, 77 & 98"
103648|NCT01961115|O2|Outcome|Cohort B|"Pts.enrolled 2-6 wks after failing anti-PD-1/PDL-1~Pts. receive 100 mg po bid INCB024360 continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 & 98"
103649|NCT01961115|O1|Outcome|Cohort A|"Pts.enrolled >6 wks after failing anti-PD-1/PDL-1~Pts will receive 300mg INCB024360 p.o. bid continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 & 98"
103650|NCT01961115|O3|Outcome|All Other Patients|"All advanced melanoma patients not previously treated with anti-PD-1 & anti-PD-L1 who meet protocol entry criteria~Pts. will receive 300 mg INCB024360 po bid for 98 days + MELITAC 12. 1 vaccine on days 21, 28, 35, 56, 77 & 98"
103651|NCT01961115|O2|Outcome|Cohort B|"Pts.enrolled 2-6 wks after failing anti-PD-1/PDL-1~Pts. receive 100 mg po bid INCB024360 continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 & 98"
103652|NCT01961115|O1|Outcome|Cohort A|"Pts.enrolled >6 wks after failing anti-PD-1/PDL-1~Pts will receive 300mg INCB024360 p.o. bid continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 & 98"
103653|NCT01961115|O3|Outcome|All Other Patients|"All advanced melanoma patients not previously treated with anti-PD-1 & anti-PD-L1 who meet protocol entry criteria~Pts. will receive 300 mg INCB024360 po bid for 98 days + MELITAC 12. 1 vaccine on days 21, 28, 35, 56, 77 & 98"
103654|NCT01961115|O2|Outcome|Cohort B|"Pts.enrolled 2-6 wks after failing anti-PD-1/PDL-1~Pts. receive 100 mg po bid INCB024360 continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 & 98"
103655|NCT01961115|O1|Outcome|Cohort A|"Pts.enrolled >6 wks after failing anti-PD-1/PDL-1~Pts will receive 300mg INCB024360 p.o. bid continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 & 98"
103656|NCT01961115|O3|Outcome|All Other Patients|"All advanced melanoma patients not previously treated with anti-PD-1 & anti-PD-L1 who meet protocol entry criteria~Pts. will receive 300 mg INCB024360 po bid for 98 days + MELITAC 12. 1 vaccine on days 21, 28, 35, 56, 77 & 98"
103657|NCT01961115|O2|Outcome|Cohort B|"Pts.enrolled 2-6 wks after failing anti-PD-1/PDL-1~Pts. receive 100 mg po bid INCB024360 continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 & 98"
103658|NCT01961115|O1|Outcome|Cohort A|"Pts.enrolled >6 wks after failing anti-PD-1/PDL-1~Pts will receive 300mg INCB024360 p.o. bid continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 & 98"
103659|NCT01961115|O3|Outcome|All Other Patients|"All advanced melanoma patients not previously treated with anti-PD-1 & anti-PD-L1 who meet protocol entry criteria~Pts. will receive 300 mg INCB024360 po bid for 98 days + MELITAC 12. 1 vaccine on days 21, 28, 35, 56, 77 & 98"
103660|NCT01961115|O2|Outcome|Cohort B|"Pts.enrolled 2-6 wks after failing anti-PD-1/PDL-1~Pts. receive 100 mg po bid INCB024360 continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 & 98"
103661|NCT01961115|O1|Outcome|Cohort A|"Pts.enrolled >6 wks after failing anti-PD-1/PDL-1~Pts will receive 300mg INCB024360 p.o. bid continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 & 98"
103662|NCT01961115|O3|Outcome|All Other Patients|"All advanced melanoma patients not previously treated with anti-PD-1 & anti-PD-L1 who meet protocol entry criteria~Pts. will receive 300 mg INCB024360 po bid for 98 days + MELITAC 12. 1 vaccine on days 21, 28, 35, 56, 77 & 98"
103663|NCT01961115|O2|Outcome|Cohort B|"Pts.enrolled 2-6 wks after failing anti-PD-1/PDL-1~Pts. receive 100 mg po bid INCB024360 continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 & 98"
103664|NCT01961115|O1|Outcome|Cohort A|"Pts.enrolled >6 wks after failing anti-PD-1/PDL-1~Pts will receive 300mg INCB024360 p.o. bid continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 & 98"
103665|NCT01961115|O3|Outcome|All Other Patients|"All advanced melanoma patients not previously treated with anti-PD-1 & anti-PD-L1 who meet protocol entry criteria~Pts. will receive 300 mg INCB024360 po bid for 98 days + MELITAC 12. 1 vaccine on days 21, 28, 35, 56, 77 & 98"
103666|NCT01961115|O2|Outcome|Cohort B|"Pts.enrolled 2-6 wks after failing anti-PD-1/PDL-1~Pts. receive 100 mg po bid INCB024360 continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 & 98"
103667|NCT01961115|O1|Outcome|Cohort A|"Pts.enrolled >6 wks after failing anti-PD-1/PDL-1~Pts will receive 300mg INCB024360 p.o. bid continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 & 98"
103668|NCT01961115|E3|Reported Event|All Other Patients|"Pts. enrolled who have not been treated with check point inhibition~100 mg INCB024360 po bid continuous for 98 days~MELITAC 12.1 intradermal/subcutaneous on days 21, 28, 35, 56, 77, 98~Laboratory Biomarker Analysis: Correlative studies"
103669|NCT01961115|E2|Reported Event|Cohort B|Pts. enrolled 2-6 wks after failing anti-PD-1/PDL-1
103670|NCT01961115|E1|Reported Event|Cohort A|Pts. enrolled >6 wks after failing anti-PD-1/PDL-1
103671|NCT01961089|B1|Baseline|Device|"Galilei Lens Professional versus predicate devices~Galilei G6 Lens Professional (Ziemer Ophthalmic Systems AG) IOLMaster (Carl Zeiss Meditech) Lenstar 900 (Haag-Streit AG)"
103672|NCT01961089|P1|Participant Flow|Device|"Galilei Lens Professional versus predicate devices:~Galilei G6 Lens Professional (Ziemer Ophthalmic Systems AG) IOLMaster (Carl Zeiss Meditech) Lenstar 900 (Haag-Streit AG)"
103673|NCT01961089|O1|Outcome|Device|Galilei Lens G6 Professional (G6) versus IOLMaster (IOLM) and Lenstar 900 (LS)
103674|NCT01961089|O1|Outcome|Device|Galilei Lens G6 Professional (G6) versus IOLMaster (IOLM) and Lenstar 900 (LS)
103675|NCT01961089|O1|Outcome|Device|Galilei Lens G6 Professional (G6) versus IOLMaster (IOLM) and Lenstar 900 (LS)
103676|NCT01961089|E1|Reported Event|Device|Galilei G6 Lens Professional versus IOLMaster and Lenstar
103677|NCT01960907|B3|Baseline|Total|Total of all reporting groups
103678|NCT01960907|B2|Baseline|Interventional|"Patients received a system for monitoring their health status.~The system is composed by:~a touch-screen pc for the administration of daily questionnaires~RESMON PRO DIARY for the measurement of lung mechanical impedance and breathing pattern~a Medic4all Wrist Clinic for the assessment of heart rate, blood pressure, saturation, 1 lead ECG, body temperature.~Subjects received additional medical treatment following the activation of alarms by the monitoring devices.~Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources."
103679|NCT01960907|B1|Baseline|Observational|"Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources.~They followed their usual care path as provided by their local NHS"
103680|NCT01960907|P2|Participant Flow|Interventional|"Patients received a system for monitoring their health status.~The system is composed by:~a touch-screen pc for the administration of daily questionnaires~RESMON PRO DIARY for the measurement of lung mechanical impedance and breathing pattern~a Medic4all Wrist Clinic for the assessment of heart rate, blood pressure, saturation, 1 lead ECG, body temperature.~Subjects received medical treatment following the activation of alarms by the monitoring devices.~Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources."
103681|NCT01960907|P1|Participant Flow|Observational|"Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources.~They followed their usual care path as provided by their local NHS."
103682|NCT01960907|O2|Outcome|Observational, Previously Hopitalized for COPD Exacerb.|Patients in the observational group that were hospitalized the year before the study for a COPD exacerbation
103683|NCT01960907|O1|Outcome|Monitored, Previously Hopitalized for COPD Exacerbation|Patients in the monitored group that were hospitalized the year before the study for a COPD exacerbation
103684|NCT01960907|O2|Outcome|Interventional|"Patients received a system for monitoring their health status.~The system is composed by:~a touch-screen pc for the administration of daily questionnaires~RESMON PRO DIARY for the measurement of lung mechanical impedance and breathing pattern~a Medic4all Wrist Clinic for the assessment of heart rate, blood pressure, saturation, 1 lead ECG, body temperature.~Subjects received additional medical treatment following the activation of alarms by the monitoring devices.~Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources."
103685|NCT01960907|O1|Outcome|Observational|"Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources.~They followed their usual care path as provided by their local NHS."
103686|NCT01960907|O2|Outcome|Interventional|"Patients received a system for monitoring their health status.~The system is composed by:~a touch-screen pc for the administration of daily questionnaires~RESMON PRO DIARY for the measurement of lung mechanical impedance and breathing pattern~a Medic4all Wrist Clinic for the assessment of heart rate, blood pressure, saturation, 1 lead ECG, body temperature.~Subjects received additional medical treatment following the activation of alarms by the monitoring devices.~Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources."
103687|NCT01960907|O1|Outcome|Observational|"Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources.~They followed their usual care path as provided by their local NHS"
103688|NCT01960907|E2|Reported Event|Interventional|"Patients received a system for monitoring their health status.~The system is composed by:~a touch-screen pc for the administration of daily questionnaires~RESMON PRO DIARY for the measurement of lung mechanical impedance and breathing pattern~a Medic4all Wrist Clinic for the assessment of heart rate, blood pressure, saturation, 1 lead ECG, body temperature.~Subjects received additional medical treatment following the activation of alarms by the monitoring devices.~Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources."
103689|NCT01960907|E1|Reported Event|Observational|"Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources.~They followed their usual care path as provided by their local NHS"
103690|NCT01960842|B1|Baseline|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
103691|NCT01960842|P1|Participant Flow|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
103692|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
103693|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
103694|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
103695|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
103696|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
103697|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
103698|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
103699|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
103738|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
103700|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
103701|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
103702|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
103703|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
103704|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
103705|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
103706|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
103707|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
103708|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
103709|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
103739|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
103710|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
103711|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
103712|NCT01960842|E1|Reported Event|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
103713|NCT01960816|B1|Baseline|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway~Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
103714|NCT01960816|P1|Participant Flow|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway~Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
103715|NCT01960816|O1|Outcome|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway~Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
103716|NCT01960816|O1|Outcome|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway~Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
103717|NCT01960816|O1|Outcome|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway~Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
103718|NCT01960816|E1|Reported Event|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway~Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
103719|NCT01960725|B3|Baseline|Total|Total of all reporting groups
103720|NCT01960725|B2|Baseline|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
103721|NCT01960725|B1|Baseline|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
103722|NCT01960725|P2|Participant Flow|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
103723|NCT01960725|P1|Participant Flow|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
103724|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
103725|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
103726|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
103727|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
103728|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
103729|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
103730|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
103731|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
103732|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
103733|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
103734|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
103735|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
103736|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
103740|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
103741|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
103742|NCT01960725|E2|Reported Event|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
103743|NCT01960725|E1|Reported Event|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
103744|NCT01960530|B1|Baseline|All Participants|All participants received no IMP, dexamethasone (non-IMP), oral infacort, oral hydrocortisone, i.v. hydrocortisone
103745|NCT01960530|P1|Participant Flow|5-period Crossover|"Study Period 1 (Endogenous Cortisol): No IMP was administered. Subjects were observed over a 24 hour period, during which sleep disruption was minimised, to record their endogenous cortisol production as a baseline figure and to confirm eligibility for the subsequent study periods.~Study Period 2 (Dexamethasone): Subjects were admitted to the unit following a final confirmation of eligibility, prior to administration with Dexamethasone.~Study Periods 3 and 4 (Infacort Granules or Hydrocortisone Tablets): Subjects were admitted to the unit and ongoing eligibility was confirmed. Subjects received both treatments (1 in Period 3, and 1 in Period 4), and were randomised using the PROC PLAN procedure of SAS. Subjects received Dexamethasone 1 hour prior to IMP administration.~Study Period 5 (I.V. Hydrocortisone Injection): Subjects were admitted to the unit and ongoing eligibility was confirmed. Subjects received Dexamethasone 1 hour prior to IMP administration."
103746|NCT01960530|O3|Outcome|i.v Hydrocortisone Injection|"20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~i.v. Hydrocortisone Injection"
103747|NCT01960530|O2|Outcome|Hydrocortisone Tablet|"20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Hydrocortisone Tablet"
103748|NCT01960530|O1|Outcome|Infacort®|"20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Infacort"
103749|NCT01960530|O5|Outcome|i.v Hydrocortisone Injection|"20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~i.v. Hydrocortisone Injection"
103750|NCT01960530|O4|Outcome|Hydrocortisone Tablet|"20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Hydrocortisone Tablet"
103751|NCT01960530|O3|Outcome|Infacort®|"20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Infacort"
103752|NCT01960530|O2|Outcome|Dexamethasone|"1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Dexamethasone"
103753|NCT01960530|O1|Outcome|Endogenous Cortisol|No Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
103754|NCT01960530|O5|Outcome|i.v Hydrocortisone Injection|"20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~i.v. Hydrocortisone Injection"
103755|NCT01960530|O4|Outcome|Hydrocortisone Tablet|"20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Hydrocortisone Tablet"
103756|NCT01960530|O3|Outcome|Infacort®|"20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Infacort"
103757|NCT01960530|O2|Outcome|Dexamethasone|"1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Dexamethasone"
103758|NCT01960530|O1|Outcome|Endogenous Cortisol|No Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
103825|NCT01960140|O1|Outcome|Simvastatin|Period 1: 40-mg tablet of simvastatin administered orally on Day 1.
103936|NCT01959607|B1|Baseline|Group 1|"This population comprises the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
103759|NCT01960530|O5|Outcome|i.v Hydrocortisone Injection|"20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~i.v. Hydrocortisone Injection"
103760|NCT01960530|O4|Outcome|Hydrocortisone Tablet|"20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Hydrocortisone Tablet"
103761|NCT01960530|O3|Outcome|Infacort®|"20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Infacort"
103762|NCT01960530|O2|Outcome|Dexamethasone|"1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Dexamethasone"
103763|NCT01960530|O1|Outcome|Endogenous Cortisol|No Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
103764|NCT01960530|O5|Outcome|i.v Hydrocortisone Injection|"20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~i.v. Hydrocortisone Injection"
103765|NCT01960530|O4|Outcome|Hydrocortisone Tablet|"20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Hydrocortisone Tablet"
103766|NCT01960530|O3|Outcome|Infacort®|"20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Infacort"
103767|NCT01960530|O2|Outcome|Dexamethasone|"1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Dexamethasone"
103768|NCT01960530|O1|Outcome|Endogenous Cortisol|No Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
103769|NCT01960530|O3|Outcome|i.v Hydrocortisone Injection|"20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~i.v. Hydrocortisone Injection"
103770|NCT01960530|O2|Outcome|Hydrocortisone Tablet|"20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Hydrocortisone Tablet"
103771|NCT01960530|O1|Outcome|Infacort®|"20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Infacort"
103772|NCT01960530|E5|Reported Event|i.v Hydrocortisone Injection|"20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~i.v. Hydrocortisone Injection"
103773|NCT01960530|E4|Reported Event|Hydrocortisone Tablet|"20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Hydrocortisone Tablet"
103774|NCT01960530|E3|Reported Event|Infacort®|"20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Infacort"
103775|NCT01960530|E2|Reported Event|Dexamethasone|"1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Dexamethasone"
103776|NCT01960530|E1|Reported Event|Endogenous Cortisol|No Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
103777|NCT01960400|B3|Baseline|Total|Total of all reporting groups
103778|NCT01960400|B2|Baseline|GMI + Sham TDCS|"Graded motor imagery (GMI) + sham tDCS~tDCS: both groups will receive the GMI treatments which will be performed using software and well-established procedures (www.noigroup.com). For its part, the tDCS will be applied for 5 consecutive days during the first 2 weeks of phase 1 and once a week during the 4 other weeks. The anodic (positive) stimulation over the motor cortex (M1) contralateral of the affected limb is sought to modulate cortical excitability and promote pain inhibition and cortical reorganization."
103779|NCT01960400|B1|Baseline|GMI + tDCS|"Graded motor imagery (GMI) + tDCS~tDCS: both groups will receive the GMI treatments which will be performed using software and well-established procedures (www.noigroup.com). For its part, the tDCS will be applied for 5 consecutive days during the first 2 weeks of phase 1 and once a week during the 4 other weeks. The anodic (positive) stimulation over the motor cortex (M1) contralateral of the affected limb is sought to modulate cortical excitability and promote pain inhibition and cortical reorganization."
103780|NCT01960400|P2|Participant Flow|GMI + Sham TDCS|"Graded motor imagery (GMI) + sham tDCS~tDCS: both groups will receive the GMI treatments which will be performed using software and well-established procedures (www.noigroup.com). For its part, the tDCS will be applied for 5 consecutive days during the first 2 weeks of phase 1 and once a week during the 4 other weeks. The anodic (positive) stimulation over the motor cortex (M1) contralateral of the affected limb is sought to modulate cortical excitability and promote pain inhibition and cortical reorganization."
103781|NCT01960400|P1|Participant Flow|GMI + tDCS|"Graded motor imagery (GMI) + tDCS~tDCS: both groups will receive the GMI treatments which will be performed using software and well-established procedures (www.noigroup.com). For its part, the tDCS will be applied for 5 consecutive days during the first 2 weeks of phase 1 and once a week during the 4 other weeks. The anodic (positive) stimulation over the motor cortex (M1) contralateral of the affected limb is sought to modulate cortical excitability and promote pain inhibition and cortical reorganization."
103782|NCT01960400|O2|Outcome|Placebo tDCS + GMI|"tDCS: For the group receiving the placebo tDCS, the electrodes were placed in the same position as for active stimulation using the tDCS stimulator, but with the placebo mode automatically turned off after 30 seconds of stimulation). This type of sham stimulation has been shown to reliably blind subjects (Gandiga et al., 2006).~tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
103783|NCT01960400|O1|Outcome|Active tDCS + GMI|"tDCS: In the laboratory, a constant current of an intensity of 2 mA (subthreshold intensity) was applied for 20 minutes a day for five consecutive days (Monday to Friday) during the first and the second weeks of GMI (see Fig. 1A). To help maintain the potential effects of the neurostimulation, the tDCS was also applied simultaneously with GMI once a week (Monday) during the 2 other phases until the end of the six weeks GMI program, for a total of 14 treatment sessions.~tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
103784|NCT01960400|O2|Outcome|Placebo tDCS + GMI|"tDCS: For the group receiving the placebo tDCS, the electrodes were placed in the same position as for active stimulation using the tDCS stimulator, but with the placebo mode automatically turned off after 30 seconds of stimulation). This type of sham stimulation has been shown to reliably blind subjects (Gandiga et al., 2006).~tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
103785|NCT01960400|O1|Outcome|Active tDCS + GMI|"tDCS: In the laboratory, a constant current of an intensity of 2 mA (subthreshold intensity) was applied for 20 minutes a day for five consecutive days (Monday to Friday) during the first and the second weeks of GMI (see Fig. 1A). To help maintain the potential effects of the neurostimulation, the tDCS was also applied simultaneously with GMI once a week (Monday) during the 2 other phases until the end of the six weeks GMI program, for a total of 14 treatment sessions.~tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
103786|NCT01960400|O2|Outcome|Placebo tDCS + GMI|"tDCS: For the group receiving the placebo tDCS, the electrodes were placed in the same position as for active stimulation using the tDCS stimulator, but with the placebo mode automatically turned off after 30 seconds of stimulation). This type of sham stimulation has been shown to reliably blind subjects (Gandiga et al., 2006).~tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
103787|NCT01960400|O1|Outcome|Active tDCS + GMI|"tDCS: In the laboratory, a constant current of an intensity of 2 mA (subthreshold intensity) was applied for 20 minutes a day for five consecutive days (Monday to Friday) during the first and the second weeks of GMI (see Fig. 1A). To help maintain the potential effects of the neurostimulation, the tDCS was also applied simultaneously with GMI once a week (Monday) during the 2 other phases until the end of the six weeks GMI program, for a total of 14 treatment sessions.~tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
103788|NCT01960400|O2|Outcome|Placebo tDCS + GMI|"tDCS: For the group receiving the placebo tDCS, the electrodes were placed in the same position as for active stimulation using the tDCS stimulator, but with the placebo mode automatically turned off after 30 seconds of stimulation). This type of sham stimulation has been shown to reliably blind subjects (Gandiga et al., 2006).~tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
103826|NCT01960140|O2|Outcome|Baricitinib and Simvastatin|Period 2: 10-mg dose of baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally QD on Days 3 through 7, with coadministration of 40-mg simvastatin tablet on Day 6.
103827|NCT01960140|O1|Outcome|Simvastatin|Period 1: 40-mg tablet of simvastatin administered orally on Day 1.
103789|NCT01960400|O1|Outcome|Active tDCS + GMI|"tDCS: In the laboratory, a constant current of an intensity of 2 mA (subthreshold intensity) was applied for 20 minutes a day for five consecutive days (Monday to Friday) during the first and the second weeks of GMI (see Fig. 1A). To help maintain the potential effects of the neurostimulation, the tDCS was also applied simultaneously with GMI once a week (Monday) during the 2 other phases until the end of the six weeks GMI program, for a total of 14 treatment sessions.~tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
103790|NCT01960400|E2|Reported Event|GMI + Placebo tDCS|Graded motor imagery (GMI) + placebo tDCS
103791|NCT01960400|E1|Reported Event|GMI + Active tDCS|Graded motor imagery (GMI) + active tDCS
103792|NCT01960387|B1|Baseline|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Patients with newly diagnosed Acute Myeloid Leukemia who received clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
103793|NCT01960387|P1|Participant Flow|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Patients with newly diagnosed Acute Myeloid Leukemia who received clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
103794|NCT01960387|O1|Outcome|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus Cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
103795|NCT01960387|O1|Outcome|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus Cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
103796|NCT01960387|O1|Outcome|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus Cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
103797|NCT01960387|O1|Outcome|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus Cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
103798|NCT01960387|E1|Reported Event|Clofarabine (40mg/m2/Day) + Cytarabine (1g/m2/Day)|Patients with Newly Diagnosed Acute Myeloid Leukemia who received clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m2 daily plus cytarabine at a dose of 1g/m2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration, on days 1 through 5.
103799|NCT01960296|B3|Baseline|Total|Total of all reporting groups
103800|NCT01960296|B2|Baseline|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
103801|NCT01960296|B1|Baseline|Clopidogrel|Continue home dose of clopidogrel into surgery
103802|NCT01960296|P2|Participant Flow|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
103803|NCT01960296|P1|Participant Flow|Clopidogrel|Continue home dose of clopidogrel into surgery
103804|NCT01960296|O2|Outcome|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
103805|NCT01960296|O1|Outcome|Clopidogrel|Continue home dose of clopidogrel into surgery
103806|NCT01960296|O2|Outcome|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
103807|NCT01960296|O1|Outcome|Clopidogrel|Continue home dose of clopidogrel into surgery
103808|NCT01960296|O2|Outcome|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
103809|NCT01960296|O1|Outcome|Clopidogrel|Continue home dose of clopidogrel into surgery
103810|NCT01960296|O2|Outcome|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
103811|NCT01960296|O1|Outcome|Clopidogrel|Continue home dose of clopidogrel into surgery
103812|NCT01960296|O2|Outcome|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
103813|NCT01960296|O1|Outcome|Clopidogrel|Continue home dose of clopidogrel into surgery
103814|NCT01960296|O2|Outcome|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
103815|NCT01960296|O1|Outcome|Clopidogrel|Continue home dose of clopidogrel into surgery
103816|NCT01960296|O2|Outcome|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
103817|NCT01960296|O1|Outcome|Clopidogrel|Continue home dose of clopidogrel into surgery
103818|NCT01960296|O2|Outcome|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
103819|NCT01960296|O1|Outcome|Clopidogrel|Continue home dose of clopidogrel into surgery
103820|NCT01960296|E2|Reported Event|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
103821|NCT01960296|E1|Reported Event|Clopidogrel|Continue home dose of clopidogrel into surgery
103822|NCT01960140|B1|Baseline|Simvastatin Then Baricitinib and Simvastatin|"Period 1: 40-mg tablet of simvastatin administered orally on Day 1.~Period 2: 10-mg dose of baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally QD on Days 3 through 7, with coadministration of 40-mg simvastatin tablet on Day 6."
103823|NCT01960140|P1|Participant Flow|Simvastatin Then Baricitinib and Simvastatin|"Period 1: 40-milligram (mg) tablet of simvastatin administered orally on Day 1.~Period 2: 10-mg dose of baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally once daily (QD) on Days 3 through 7, with coadministration of 40-mg simvastatin tablet on Day 6."
103824|NCT01960140|O2|Outcome|Baricitinib and Simvastatin|Period 2: 10-mg dose of Baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally QD on Days 3 through 7, with coadministration of 40-mg simvastatin tablet on Day 6.
103828|NCT01960140|E3|Reported Event|Baricitinib and Simvastatin|"A 10-mg dose of baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally QD on Days 6 and 7, with coadministration of 40-mg simvastatin tablet on Day 6.~AEs are reported postdose on Day 6 up to Day 18."
103829|NCT01960140|E2|Reported Event|Baricitinib|"A 10-mg dose of baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally QD on Days 3 through 5.~AEs are reported postdose on Day 3 through predose on Day 6."
103830|NCT01960140|E1|Reported Event|Simvastatin|"A 40-mg tablet of simvastatin administered orally on Day 1.~Adverse events (AEs) are reported from baseline through predose on Day 3."
103831|NCT01960114|B3|Baseline|Total|Total of all reporting groups
103832|NCT01960114|B2|Baseline|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
103833|NCT01960114|B1|Baseline|Placebo|Placebo (two matching placebo tablets)
103834|NCT01960114|P2|Participant Flow|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
103835|NCT01960114|P1|Participant Flow|Placebo|Placebo (two matching placebo tablets)
103836|NCT01960114|O2|Outcome|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
103837|NCT01960114|O1|Outcome|Placebo|Placebo (two matching placebo tablets)
103838|NCT01960114|O2|Outcome|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
103839|NCT01960114|O1|Outcome|Placebo|Placebo (two matching placebo tablets)
103840|NCT01960114|O2|Outcome|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
103841|NCT01960114|O1|Outcome|Placebo|Placebo (two matching placebo tablets)
103842|NCT01960114|O2|Outcome|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
103843|NCT01960114|O1|Outcome|Placebo|Placebo (two matching placebo tablets)
103844|NCT01960114|O2|Outcome|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
103845|NCT01960114|O1|Outcome|Placebo|Placebo (two matching placebo tablets)
103846|NCT01960114|E2|Reported Event|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
103847|NCT01960114|E1|Reported Event|Placebo|Placebo (two matching placebo tablets)
103848|NCT01959945|B5|Baseline|Total|Total of all reporting groups
103849|NCT01959945|B4|Baseline|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103850|NCT01959945|B3|Baseline|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103851|NCT01959945|B2|Baseline|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103852|NCT01959945|B1|Baseline|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103853|NCT01959945|P4|Participant Flow|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103854|NCT01959945|P3|Participant Flow|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103855|NCT01959945|P2|Participant Flow|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103856|NCT01959945|P1|Participant Flow|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103857|NCT01959945|O4|Outcome|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103858|NCT01959945|O3|Outcome|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103859|NCT01959945|O2|Outcome|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103860|NCT01959945|O1|Outcome|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103861|NCT01959945|O4|Outcome|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103862|NCT01959945|O3|Outcome|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103863|NCT01959945|O2|Outcome|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103864|NCT01959945|O1|Outcome|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103865|NCT01959945|O4|Outcome|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103866|NCT01959945|O3|Outcome|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103867|NCT01959945|O2|Outcome|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103868|NCT01959945|O1|Outcome|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103869|NCT01959945|O4|Outcome|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103870|NCT01959945|O3|Outcome|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103871|NCT01959945|O2|Outcome|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103872|NCT01959945|O1|Outcome|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103873|NCT01959945|E4|Reported Event|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103874|NCT01959945|E3|Reported Event|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103875|NCT01959945|E2|Reported Event|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103876|NCT01959945|E1|Reported Event|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
103877|NCT01959932|B4|Baseline|Total|Total of all reporting groups
103878|NCT01959932|B3|Baseline|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
103879|NCT01959932|B2|Baseline|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
103880|NCT01959932|B1|Baseline|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
103881|NCT01959932|P3|Participant Flow|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
103882|NCT01959932|P2|Participant Flow|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
103883|NCT01959932|P1|Participant Flow|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
103884|NCT01959932|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
103885|NCT01959932|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
103886|NCT01959932|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
103887|NCT01959932|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
103888|NCT01959932|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
103889|NCT01959932|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
103890|NCT01959932|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
103891|NCT01959932|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
103892|NCT01959932|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
103893|NCT01959932|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
103894|NCT01959932|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
103895|NCT01959932|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
103896|NCT01959932|E4|Reported Event|Enrolled But Not Randomized|Subjects who tried the THS 2.2 at Admission (Day -2) but were not randomized in 1 of the 3 arms as they were back-up subjects
103897|NCT01959932|E3|Reported Event|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
103898|NCT01959932|E2|Reported Event|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
103899|NCT01959932|E1|Reported Event|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
103900|NCT01959880|B5|Baseline|Total|Total of all reporting groups
103901|NCT01959880|B4|Baseline|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
103902|NCT01959880|B3|Baseline|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
103903|NCT01959880|B2|Baseline|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
103904|NCT01959880|B1|Baseline|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
103905|NCT01959880|P4|Participant Flow|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
107839|NCT01943292|O2|Outcome|Defactinib 400 mg Bid|400 mg po bid defactinib
103906|NCT01959880|P3|Participant Flow|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
103907|NCT01959880|P2|Participant Flow|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
103908|NCT01959880|P1|Participant Flow|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
103909|NCT01959880|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
103910|NCT01959880|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
103911|NCT01959880|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
103912|NCT01959880|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
103913|NCT01959880|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
103914|NCT01959880|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
103915|NCT01959880|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
103916|NCT01959880|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
103917|NCT01959880|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
103918|NCT01959880|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
103919|NCT01959880|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
103920|NCT01959880|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
103921|NCT01959880|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
103922|NCT01959880|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
103923|NCT01959880|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
103924|NCT01959880|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
103925|NCT01959880|E4|Reported Event|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
103926|NCT01959880|E3|Reported Event|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
103927|NCT01959880|E2|Reported Event|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
103928|NCT01959880|E1|Reported Event|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
103929|NCT01959685|B1|Baseline|Up to 250 mg Androxal|Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
103930|NCT01959685|P1|Participant Flow|Up to 250 mg Androxal|Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
103931|NCT01959685|O1|Outcome|Up to 250 mg Androxal|Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
103932|NCT01959685|O1|Outcome|Up to 250 mg Androxal|Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
103933|NCT01959685|E1|Reported Event|Up to 250 mg Androxal|Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
103934|NCT01959607|B3|Baseline|Total|Total of all reporting groups
103935|NCT01959607|B2|Baseline|Group 2|"This population comprises the following sequences:~Sequence THS 2.2 then NRT~Sequence NRT then THS 2.2"
103937|NCT01959607|P4|Participant Flow|NRT Then THS 2.2|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single administration of NRT gum [Nicorette ® 2mg])~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of THS 2.2)."
103938|NCT01959607|P3|Participant Flow|THS 2.2 Then NRT|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of THS 2.2)~Day 2 = wash-out~Day 3 = 2nd intervention (single administration of NRT gum [Nicorette ® 2mg])."
103939|NCT01959607|P2|Participant Flow|CC Then THS 2.2|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of CC)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of THS 2.2)."
103940|NCT01959607|P1|Participant Flow|THS 2.2 Then CC|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of THS 2.2)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of CC)."
103941|NCT01959607|O4|Outcome|NRT - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then NRT~Sequence NRT then THS 2.2"
103942|NCT01959607|O3|Outcome|THS 2.2 - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then NRT~Sequence NRT then THS 2.2"
103943|NCT01959607|O2|Outcome|CC - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
103944|NCT01959607|O1|Outcome|THS 2.2 - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
103945|NCT01959607|O4|Outcome|NRT - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then NRT~Sequence NRT then THS 2.2"
103946|NCT01959607|O3|Outcome|THS 2.2 - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then NRT~Sequence NRT then THS 2.2"
103947|NCT01959607|O2|Outcome|CC - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
103948|NCT01959607|O1|Outcome|THS 2.2 - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
103949|NCT01959607|E3|Reported Event|Enrolled But Not Randomized|Subjects who tried the THS 2.2 at Admission (Day -1) but were not randomized in 1 of the 2 groups as they were back-up subjects
103950|NCT01959607|E2|Reported Event|Group 2|"This population comprises the following sequences:~Sequence THS 2.2 then NRT~Sequence NRT then THS 2.2"
103951|NCT01959607|E1|Reported Event|Group 1|"This population comprises the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
103952|NCT01959581|B1|Baseline|Movement Enhancing Device|"Guided play while wearing a movement assisting device~Movement Enhancing Device: Naturalistic play activities using the hands while wearing the movement enhancing device."
103953|NCT01959581|P1|Participant Flow|Movement Enhancing Device|"Guided play while wearing a movement assisting device~Movement Enhancing Device: Naturalistic play activities using the hands while wearing the movement enhancing device."
103954|NCT01959581|O1|Outcome|Movement Enhancing Device|"Guided play while wearing a movement assisting device~Movement Enhancing Device: Naturalistic play activities using the hands while wearing the movement enhancing device."
103955|NCT01959581|E1|Reported Event|Movement Enhancing Device|"Guided play while wearing a movement assisting device~Movement Enhancing Device: Naturalistic play activities using the hands while wearing the movement enhancing device."
103956|NCT01959529|B3|Baseline|Total|Total of all reporting groups
103957|NCT01959529|B2|Baseline|Insulin Glargine|Subjects received IGlar 100 units/mL OD subcutaneously (S.C.; under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pretrial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IGlar). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IGlar OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IGlar OD, and the bolus component was calculated and switched to IAsp. The trial was event driven with a realised observation period up to 33 months.
103958|NCT01959529|B1|Baseline|Insulin Degludec|Subjects received IDeg 100 units/mL OD S.C. (under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pre-trial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IDeg). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IDeg OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IDeg OD, and the bolus component was calculated and switched to IAsp. The trial was event driven for with a realised observation period up to 33 months.
103959|NCT01959529|P2|Participant Flow|Insulin Glargine|Subjects received insulin glargine (IGlar) 100 units/mL OD subcutaneously (S.C.; under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pretrial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IGlar). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IGlar OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IGlar OD, and the bolus component was calculated and switched to IAsp. The trial was event driven with a realised observation period up to 33 months.
103960|NCT01959529|P1|Participant Flow|Insulin Degludec|Subjects received insulin degludec (IDeg) 100 units/mL once daily (OD) subcutaneously (S.C.; under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pre-trial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IDeg). The pre-trial bolus insulin was allowed and could be replaced with insulin aspart (IAsp) at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IDeg OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin twice daily (BID), the total basal component was calculated, reduced by 20- 30% and switched to IDeg OD, and the bolus component was calculated and switched to IAsp. The trial was event driven for with a realised observation period up to 33 months.
103961|NCT01959529|O2|Outcome|Insulin Glargine|Subjects received IGlar 100 units/mL OD subcutaneously (S.C.; under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pretrial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IGlar). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IGlar OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IGlar OD, and the bolus component was calculated and switched to IAsp. The trial was event driven with a realised observation period up to 33 months.
103962|NCT01959529|O1|Outcome|Insulin Degludec|Subjects received IDeg 100 units/mL OD S.C. (under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pre-trial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IDeg). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IDeg OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IDeg OD, and the bolus component was calculated and switched to IAsp. The trial was event driven for with a realised observation period up to 33 months.
103963|NCT01959529|O2|Outcome|Insulin Glargine|Subjects received IGlar 100 units/mL OD subcutaneously (S.C.; under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pretrial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IGlar). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IGlar OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IGlar OD, and the bolus component was calculated and switched to IAsp. The trial was event driven with a realised observation period up to 33 months.
103964|NCT01959529|O1|Outcome|Insulin Degludec|Subjects received IDeg 100 units/mL OD S.C. (under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pre-trial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IDeg). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IDeg OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IDeg OD, and the bolus component was calculated and switched to IAsp. The trial was event driven for with a realised observation period up to 33 months.
103965|NCT01959529|O2|Outcome|Insulin Glargine|Subjects received IGlar 100 units/mL OD subcutaneously (S.C.; under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pretrial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IGlar). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IGlar OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IGlar OD, and the bolus component was calculated and switched to IAsp. The trial was event driven with a realised observation period up to 33 months.
103966|NCT01959529|O1|Outcome|Insulin Degludec|Subjects received IDeg 100 units/mL OD S.C. (under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pre-trial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IDeg). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IDeg OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IDeg OD, and the bolus component was calculated and switched to IAsp. The trial was event driven for with a realised observation period up to 33 months.
103967|NCT01959529|O2|Outcome|Insulin Glargine|Subjects received IGlar 100 units/mL OD subcutaneously (S.C.; under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pretrial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IGlar). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IGlar OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IGlar OD, and the bolus component was calculated and switched to IAsp. The trial was event driven with a realised observation period up to 33 months.
103991|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
103992|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
104122|NCT01958671|O3|Outcome|Placebo|Participants received placebo to ertugliflozin once daily for 26 weeks.
103968|NCT01959529|O1|Outcome|Insulin Degludec|Subjects received IDeg 100 units/mL OD S.C. (under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pre-trial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IDeg). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IDeg OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IDeg OD, and the bolus component was calculated and switched to IAsp. The trial was event driven for with a realised observation period up to 33 months.
103969|NCT01959529|E2|Reported Event|Insulin Glargine|Subjects received IGlar 100 units/mL OD subcutaneously (S.C.; under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pretrial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IGlar). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IGlar OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IGlar OD, and the bolus component was calculated and switched to IAsp. The trial was event driven with a realised observation period up to 33 months.
103970|NCT01959529|E1|Reported Event|Insulin Degludec|Subjects received IDeg 100 units/mL OD S.C. (under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pre-trial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IDeg). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IDeg OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IDeg OD, and the bolus component was calculated and switched to IAsp. The trial was event driven for with a realised observation period up to 33 months.
103971|NCT01959516|B1|Baseline|All Participants (Intent To Treat Analysis,ITT)|All participants who were randomized to one of the two treatment sequences in a ratio of 1:1. Participants will receive sequence A = glycopyrronium + placebo to tiotropium during 28 days, followed by a 14 day washout period, then sequence B= tiotropium + placebo to glycopyrronium for 28 days.
103972|NCT01959516|P2|Participant Flow|Tiotropium First, Then Glycopyrronium|Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD + placebo of tiotropiumto) Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium)
103973|NCT01959516|P1|Participant Flow|"Glycopyrronium First, Then Tiotropium"|Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium) Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto)
103974|NCT01959516|O2|Outcome|Tiotropium From Sequence A to B and Sequence B to A|Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD + placebo of tiotropiumto) Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium)
103975|NCT01959516|O1|Outcome|Glycopyronium From Sequence A to B and Sequence B to A|Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium) Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto)
103976|NCT01959516|O2|Outcome|Tiotropium From Sequence A to B and Sequence B to A|Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD + placebo of tiotropiumto) Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium)
103977|NCT01959516|O1|Outcome|Glycopyronium From Sequence A to B and Sequence B to A|Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium) Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto)
103978|NCT01959516|E2|Reported Event|Tiotropium From Sequence A to B and Sequence B to A|Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD + placebo of tiotropiumto) Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium)
103979|NCT01959516|E1|Reported Event|Glycopyronium From Sequence A to B and Sequence B to A|Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium) Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto)
103980|NCT01959503|B3|Baseline|Total|Total of all reporting groups
103981|NCT01959503|B2|Baseline|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
103982|NCT01959503|B1|Baseline|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
103983|NCT01959503|P2|Participant Flow|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
103984|NCT01959503|P1|Participant Flow|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
103985|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
103986|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
103987|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
103988|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
103989|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
103990|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
103993|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
103994|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
103995|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
103996|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
103997|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
103998|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
103999|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
104000|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
104001|NCT01959503|E2|Reported Event|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
104002|NCT01959503|E1|Reported Event|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
104003|NCT01959412|B1|Baseline|All Participants|All participants randomized to one of six treatment sequences
104004|NCT01959412|P6|Participant Flow|Sequence 6 (Placebo)|Placebo, indacaterol 37.5 μg, indacaterol 27.5 μg indacaterol 55 μg, indacaterol 150 μg, indacaterol 75 μg Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
104005|NCT01959412|P5|Participant Flow|Sequence 5 (Ind 27.5 μg)|indacaterol 27.5 μg placebo indacaterol 150 μg indacaterol 37.5 μg indacaterol 75 μg indacaterol 55 μg Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
104006|NCT01959412|P4|Participant Flow|Sequence 1 (Ind 37.5 μg)|indacaterol 37.5 μg indacaterol 55μg Placebo indacaterol 75μg indacaterol 27.5μg indacaterol 150μg indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
104007|NCT01959412|P3|Participant Flow|Sequence 2 (Ind 55 μg)|indacaterol 55 μg indacaterol 75 μg indacaterol 37.5 μg indacaterol 150 μg placebo indacaterol 27.5 μg Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
104008|NCT01959412|P2|Participant Flow|Sequence 3 (Ind 75 μg)|indacaterol 75 μg indacaterol 150 μg indacaterol 55 μg indacaterol 27.5 μg indacaterol 37.5 μg placebo Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
104009|NCT01959412|P1|Participant Flow|Sequence 4 (Ind 150 μg)|indacaterol 150 μg, indacaterol 27.5 μg, indacaterol 75 μg, placebo indacaterol 55 μg indacaterol 37.5 μg Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
104010|NCT01959412|O6|Outcome|Placebo|Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
104011|NCT01959412|O5|Outcome|Ind 27.5|Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
104012|NCT01959412|O4|Outcome|Ind 37.5 μg|Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
104013|NCT01959412|O3|Outcome|Ind 55 μg|Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
104014|NCT01959412|O2|Outcome|Ind 75 μg|Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
104015|NCT01959412|O1|Outcome|Ind 150 μg|Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
104016|NCT01959412|O6|Outcome|Placebo|Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
104017|NCT01959412|O5|Outcome|Ind 27.5|Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
104018|NCT01959412|O4|Outcome|Ind 37.5 μg|Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
104019|NCT01959412|O3|Outcome|Ind 55 μg|Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
104020|NCT01959412|O2|Outcome|Ind 75 μg|Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
104021|NCT01959412|O1|Outcome|Ind 150 μg|Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
104022|NCT01959412|O6|Outcome|Placebo|Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
104023|NCT01959412|O5|Outcome|Ind 27.5|Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
104024|NCT01959412|O4|Outcome|Ind 37.5 μg|Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
104025|NCT01959412|O3|Outcome|Ind 55 μg|Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
104026|NCT01959412|O2|Outcome|Ind 75 μg|Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
104027|NCT01959412|O1|Outcome|Ind 150 μg|Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
104028|NCT01959412|O6|Outcome|Placebo|Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
104082|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
104029|NCT01959412|O5|Outcome|Ind 27.5|Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
104030|NCT01959412|O4|Outcome|Ind 37.5 μg|Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
104031|NCT01959412|O3|Outcome|Ind 55 μg|Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
104032|NCT01959412|O2|Outcome|Ind 75 μg|Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
104033|NCT01959412|O1|Outcome|Ind 150 μg|Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
104034|NCT01959412|O6|Outcome|Placebo|Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
104035|NCT01959412|O5|Outcome|Ind 27.5|Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
104036|NCT01959412|O4|Outcome|Ind 37.5 μg|Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
104037|NCT01959412|O3|Outcome|Ind 55 μg|Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
104038|NCT01959412|O2|Outcome|Ind 75 μg|Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
104039|NCT01959412|O1|Outcome|Ind 150 μg|Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
104040|NCT01959412|E6|Reported Event|Placebo|Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
104041|NCT01959412|E5|Reported Event|Ind 27.5|Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
104042|NCT01959412|E4|Reported Event|Ind 37.5 μg|Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
104043|NCT01959412|E3|Reported Event|Ind 55 μg|Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
104083|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
104044|NCT01959412|E2|Reported Event|Ind 75 μg|Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
104045|NCT01959412|E1|Reported Event|Ind 150 μg|Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
104046|NCT01959035|B1|Baseline|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
104047|NCT01959035|P1|Participant Flow|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month depending on the last dose that they had received in Study 14724A; 6 intramuscular (IM) injections starting at baseline
104048|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
104049|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
104050|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
104051|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
104052|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
104053|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
104054|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
104055|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
104056|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
104057|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
104058|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
104059|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
104060|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
104061|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
104062|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
104063|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
104064|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
104065|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
104066|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
104067|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
104068|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
104069|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
104070|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
104071|NCT01959035|E1|Reported Event|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
104072|NCT01958827|B1|Baseline|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
104073|NCT01958827|P1|Participant Flow|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
104074|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
104075|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
104076|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
104077|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
104078|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
104079|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
104080|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
104081|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
104084|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
104085|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
104086|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
104087|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
104088|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
104089|NCT01958827|E1|Reported Event|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
104090|NCT01958788|B1|Baseline|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments
104091|NCT01958788|P1|Participant Flow|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
104092|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
104093|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
104094|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
104095|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
104096|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
104097|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
104098|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
104099|NCT01958788|E1|Reported Event|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments
104100|NCT01958671|B4|Baseline|Total|Total of all reporting groups
104101|NCT01958671|B3|Baseline|Placebo/Metformin|Phase A: Placebo to ertugliflozin administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Participants not rescued with open-label metformin in Phase A will also receive blinded metformin up to twice daily for 26 weeks in addition to placebo. Participants rescued with metformin in Phase A will continue to receive open-label metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
104102|NCT01958671|B2|Baseline|Ertugliflozin 15 mg/Ertugliflozin 15 mg|Phase A: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
104103|NCT01958671|B1|Baseline|Ertugliflozin 5 mg/Ertugliflozin 5 mg|Phase A: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
104104|NCT01958671|P3|Participant Flow|Placebo/Metformin|Phase A: Placebo to ertugliflozin administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Participants not rescued with open-label metformin in Phase A will also receive blinded metformin up to twice daily for 26 weeks in addition to placebo. Participants rescued with metformin in Phase A will continue to receive open-label metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
104105|NCT01958671|P2|Participant Flow|Ertugliflozin 15 mg/Ertugliflozin 15 mg|Phase A: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
104106|NCT01958671|P1|Participant Flow|Ertugliflozin 5 mg/Ertugliflozin 5 mg|Phase A: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
104107|NCT01958671|O3|Outcome|Placebo|Participants received placebo to ertugliflozin once daily for 26 weeks.
104108|NCT01958671|O2|Outcome|Ertugliflozin 15 mg|Participants received ertugliflozin 15 mg once daily for 26 weeks
104109|NCT01958671|O1|Outcome|Ertugliflozin 5 mg|Participants received ertugliflozin 5 mg once daily for 26 weeks.
104110|NCT01958671|O3|Outcome|Placebo|Participants received placebo to ertugliflozin once daily for 26 weeks.
104111|NCT01958671|O2|Outcome|Ertugliflozin 15 mg|Participants received ertugliflozin 15 mg once daily for 26 weeks.
104112|NCT01958671|O1|Outcome|Ertugliflozin 5 mg|Participants received ertugliflozin 5 mg once daily for 26 weeks.
104113|NCT01958671|O3|Outcome|Placebo|Participants received placebo to ertugliflozin once daily for 26 weeks.
104123|NCT01958671|O2|Outcome|Ertugliflozin 15 mg|Participants received ertugliflozin 15 mg once daily for 26 weeks.
104124|NCT01958671|O1|Outcome|Ertugliflozin 5 mg|Participants received ertugliflozin 5 mg once daily for 26 weeks.
104125|NCT01958671|O3|Outcome|Placebo|Participants received placebo to ertugliflozin once daily for 26 weeks.
104126|NCT01958671|O2|Outcome|Ertugliflozin 15 mg|Participants received ertugliflozin 15 mg once daily for 26 weeks
104127|NCT01958671|O1|Outcome|Ertugliflozin 5 mg|Participants received ertugliflozin 5 mg once daily for 26 weeks.
104128|NCT01958671|O3|Outcome|Placebo|Participants received placebo to ertugliflozin once daily for 26 weeks.
104129|NCT01958671|O2|Outcome|Ertugliflozin 15 mg|Participants received ertugliflozin 15 mg once daily for 26 weeks.
104130|NCT01958671|O1|Outcome|Ertugliflozin 5 mg|Participants received ertugliflozin 5 mg once daily for 26 weeks.
104131|NCT01958671|O3|Outcome|Placebo|Participants received placebo to ertugliflozin once daily for 26 weeks.
104132|NCT01958671|O2|Outcome|Ertugliflozin 15 mg|Participants received ertugliflozin 15 mg once daily for 26 weeks
104133|NCT01958671|O1|Outcome|Ertugliflozin 5 mg|Participants received ertugliflozin 5 mg once daily for 26 weeks.
104134|NCT01958671|O3|Outcome|Placebo/Metformin|Phase A: Placebo to ertugliflozin administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Participants not rescued with open-label metformin in Phase A will also receive blinded metformin up to twice daily for 26 weeks in addition to placebo. Participants rescued with metformin in Phase A will continue to receive open-label metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
104135|NCT01958671|O2|Outcome|Ertugliflozin 15 mg/Ertugliflozin 15 mg|Phase A: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
104136|NCT01958671|O1|Outcome|Ertugliflozin 5 mg/Ertugliflozin 5 mg|Phase A: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
104137|NCT01958671|O3|Outcome|Placebo/Metformin|Phase A: Placebo to ertugliflozin administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Participants not rescued with open-label metformin in Phase A will also receive blinded metformin up to twice daily for 26 weeks in addition to placebo. Participants rescued with metformin in Phase A will continue to receive open-label metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
104138|NCT01958671|O2|Outcome|Ertugliflozin 15 mg/Ertugliflozin 15 mg|Phase A: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
104139|NCT01958671|O1|Outcome|Ertugliflozin 5 mg/Ertugliflozin 5 mg|Phase A: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
104140|NCT01958671|O3|Outcome|Placebo|Participants received placebo to ertugliflozin once daily for 26 weeks.
104141|NCT01958671|O2|Outcome|Ertugliflozin 15 mg|Participants received ertugliflozin 15 mg once daily for 26 weeks.
104142|NCT01958671|O1|Outcome|Ertugliflozin 5 mg|Participants received ertugliflozin 5 mg once daily for 26 weeks.
104143|NCT01958671|E3|Reported Event|Placebo/Metformin|Phase A: Placebo to ertugliflozin administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Participants not rescued with open-label metformin in Phase A will also receive blinded metformin up to twice daily for 26 weeks in addition to placebo. Participants rescued with metformin in Phase A will continue to receive open-label metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
104144|NCT01958671|E2|Reported Event|Ertugliflozin 15 mg/Ertugliflozin 15 mg|Phase A: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
104145|NCT01958671|E1|Reported Event|Ertugliflozin 5 mg/Ertugliflozin 5 mg|Phase A: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
104146|NCT01958645|B4|Baseline|Total|Total of all reporting groups
104147|NCT01958645|B3|Baseline|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
104148|NCT01958645|B2|Baseline|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
104149|NCT01958645|B1|Baseline|Placebo|Placebo (Saline solution for infusion)
104150|NCT01958645|P3|Participant Flow|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
104151|NCT01958645|P2|Participant Flow|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
104152|NCT01958645|P1|Participant Flow|Placebo|Placebo (Saline solution for infusion)
104153|NCT01958645|O4|Outcome|Placebo Dose 2|Placebo dose 2 (Saline solution for infusion)
104154|NCT01958645|O3|Outcome|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
104155|NCT01958645|O2|Outcome|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
104156|NCT01958645|O1|Outcome|Placebo Dose 1|Placebo dose 1 (Saline solution for infusion)
104157|NCT01958645|O4|Outcome|Placebo Dose 2|Placebo dose 2 (Saline solution for infusion)
104158|NCT01958645|O3|Outcome|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
104159|NCT01958645|O2|Outcome|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
104160|NCT01958645|O1|Outcome|Placebo Dose 1|Placebo dose 1 (Saline solution for infusion)
104161|NCT01958645|O4|Outcome|Placebo Dose 2|Placebo dose 2 (Saline solution for infusion)
104162|NCT01958645|O3|Outcome|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
104163|NCT01958645|O2|Outcome|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
104164|NCT01958645|O1|Outcome|Placebo Dose 1|Placebo dose 1 (Saline solution for infusion)
104165|NCT01958645|O4|Outcome|Placebo Dose 2|Placebo dose 2 (Saline solution for infusion)
104166|NCT01958645|O3|Outcome|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
104167|NCT01958645|O2|Outcome|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
104168|NCT01958645|O1|Outcome|Placebo Dose 1|Placebo dose 1 (Saline solution for infusion)
104169|NCT01958645|O3|Outcome|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
104170|NCT01958645|O2|Outcome|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
104171|NCT01958645|O1|Outcome|Placebo|Placebo (Saline solution for infusion)
104172|NCT01958645|E3|Reported Event|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
104173|NCT01958645|E2|Reported Event|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
104174|NCT01958645|E1|Reported Event|Placebo|Placebo (Saline solution for infusion)
104175|NCT01958619|B5|Baseline|Total|Total of all reporting groups
104176|NCT01958619|B4|Baseline|Treatment D: 800mg OZ439 + TPGS|OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
104177|NCT01958619|B3|Baseline|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
104178|NCT01958619|B2|Baseline|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
104179|NCT01958619|B1|Baseline|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
104180|NCT01958619|P4|Participant Flow|Treatment D: 800mg OZ439 + TPGS|OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
104181|NCT01958619|P3|Participant Flow|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
104182|NCT01958619|P2|Participant Flow|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
104183|NCT01958619|P1|Participant Flow|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
104184|NCT01958619|O3|Outcome|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
104185|NCT01958619|O2|Outcome|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
104186|NCT01958619|O1|Outcome|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
104187|NCT01958619|O3|Outcome|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
104188|NCT01958619|O2|Outcome|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
104189|NCT01958619|O1|Outcome|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
104190|NCT01958619|O4|Outcome|Treatment D: 800mg OZ439 + TPGS|OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
104191|NCT01958619|O3|Outcome|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
104192|NCT01958619|O2|Outcome|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
104193|NCT01958619|O1|Outcome|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
104194|NCT01958619|O4|Outcome|Treatment D: 800mg OZ439 + TPGS|OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
104195|NCT01958619|O3|Outcome|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
104196|NCT01958619|O2|Outcome|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
104197|NCT01958619|O1|Outcome|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
104198|NCT01958619|E4|Reported Event|Treatment D: 800mg OZ439 + TPGS|OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
104294|NCT01958060|O4|Outcome|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104199|NCT01958619|E3|Reported Event|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
104200|NCT01958619|E2|Reported Event|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
104201|NCT01958619|E1|Reported Event|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
104202|NCT01958606|B3|Baseline|Total|Total of all reporting groups
104203|NCT01958606|B2|Baseline|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
104204|NCT01958606|B1|Baseline|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
104205|NCT01958606|P2|Participant Flow|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
104206|NCT01958606|P1|Participant Flow|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
104207|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
104208|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
104209|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
104210|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
104211|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
104212|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
104213|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
104214|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
104215|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
104216|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
104217|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
104218|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
104219|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
104220|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
104221|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
104222|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
104223|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
104224|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
104225|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
104226|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
104227|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
104228|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
104229|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
104230|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
104231|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
104232|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
104233|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
104234|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
104235|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
104236|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
104237|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
104238|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
104239|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
104240|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
104241|NCT01958606|E2|Reported Event|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
104242|NCT01958606|E1|Reported Event|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
104243|NCT01958346|B3|Baseline|Total|Total of all reporting groups
104244|NCT01958346|B2|Baseline|Fiberoptic Intubation With Lingual Traction|"Lingual Traction: The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.~Fiberoptic Intubation"
104245|NCT01958346|B1|Baseline|Fiberoptic Intubation Alone|"Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers~Fiberoptic Intubation"
104246|NCT01958346|P2|Participant Flow|Fiberoptic Intubation With Lingual Traction|"Lingual Traction: The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.~Fiberoptic Intubation"
104247|NCT01958346|P1|Participant Flow|Fiberoptic Intubation Alone|"Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers~Fiberoptic Intubation"
104248|NCT01958346|O2|Outcome|Fiberoptic Intubation With Lingual Traction|"Lingual Traction: The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.~Fiberoptic Intubation"
104249|NCT01958346|O1|Outcome|Fiberoptic Intubation Alone|"Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers~Fiberoptic Intubation"
104250|NCT01958346|O2|Outcome|Fiberoptic Intubation With Lingual Traction|"Lingual Traction: The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.~Fiberoptic Intubation"
104251|NCT01958346|O1|Outcome|Fiberoptic Intubation Alone|"Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers~Fiberoptic Intubation"
104252|NCT01958346|E2|Reported Event|Fiberoptic Intubation With Lingual Traction|"Lingual Traction: The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.~Fiberoptic Intubation"
104253|NCT01958346|E1|Reported Event|Fiberoptic Intubation Alone|"Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers~Fiberoptic Intubation"
104254|NCT01958164|B3|Baseline|Total|Total of all reporting groups
104255|NCT01958164|B2|Baseline|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
104256|NCT01958164|B1|Baseline|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
104257|NCT01958164|P2|Participant Flow|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
104258|NCT01958164|P1|Participant Flow|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
104259|NCT01958164|O1|Outcome|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
104260|NCT01958164|O2|Outcome|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
104261|NCT01958164|O1|Outcome|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
104262|NCT01958164|O2|Outcome|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
104263|NCT01958164|O1|Outcome|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
104264|NCT01958164|O2|Outcome|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
104265|NCT01958164|O1|Outcome|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
104266|NCT01958164|O2|Outcome|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
104267|NCT01958164|O1|Outcome|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
104268|NCT01958164|E2|Reported Event|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
104269|NCT01958164|E1|Reported Event|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
104270|NCT01958060|B7|Baseline|Total|Total of all reporting groups
104271|NCT01958060|B6|Baseline|BI 1034020 (100 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104272|NCT01958060|B5|Baseline|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104273|NCT01958060|B4|Baseline|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104274|NCT01958060|B3|Baseline|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104275|NCT01958060|B2|Baseline|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104276|NCT01958060|B1|Baseline|Placebo|Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.
104277|NCT01958060|P6|Participant Flow|BI 1034020 (100 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104278|NCT01958060|P5|Participant Flow|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104279|NCT01958060|P4|Participant Flow|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104280|NCT01958060|P3|Participant Flow|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104281|NCT01958060|P2|Participant Flow|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104282|NCT01958060|P1|Participant Flow|Placebo|Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.
104283|NCT01958060|O4|Outcome|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104284|NCT01958060|O3|Outcome|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104285|NCT01958060|O2|Outcome|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104286|NCT01958060|O1|Outcome|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104287|NCT01958060|O1|Outcome|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104288|NCT01958060|O4|Outcome|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104289|NCT01958060|O3|Outcome|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104290|NCT01958060|O2|Outcome|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104291|NCT01958060|O1|Outcome|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104292|NCT01958060|O6|Outcome|BI 1034020 (100 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104293|NCT01958060|O5|Outcome|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104295|NCT01958060|O3|Outcome|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104296|NCT01958060|O2|Outcome|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104297|NCT01958060|O1|Outcome|Placebo|Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.
104298|NCT01958060|E6|Reported Event|BI 1034020 (100 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104299|NCT01958060|E5|Reported Event|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104300|NCT01958060|E4|Reported Event|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104301|NCT01958060|E3|Reported Event|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104302|NCT01958060|E2|Reported Event|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
104303|NCT01958060|E1|Reported Event|Placebo|Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.
104304|NCT01958021|B3|Baseline|Total|Total of all reporting groups
104305|NCT01958021|B2|Baseline|Placebo + Letrozole|Matching ribociclib placebo, control drug administered orally (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 placebo QD + 2.5 mg letrozole
104306|NCT01958021|B1|Baseline|LEE011 + Letrozole|LEE011 (ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD
104307|NCT01958021|P2|Participant Flow|Placebo + Letrozole|Matching ribociclib placebo, control drug administered orally (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 placebo QD + 2.5 mg letrozole
104308|NCT01958021|P1|Participant Flow|LEE011 + Letrozole|LEE011 (ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD
104309|NCT01958021|O2|Outcome|Placebo + Letrozole|Matching ribociclib placebo, control drug administered orally (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 placebo QD + 2.5 mg letrozole
104310|NCT01958021|O1|Outcome|LEE011 + Letrozole|LEE011 (ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD
104311|NCT01958021|O2|Outcome|Placebo + Letrozole|Matching ribociclib placebo, control drug administered orally (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 placebo QD + 2.5 mg letrozole
104312|NCT01958021|O1|Outcome|LEE011 + Letrozole|LEE011 (ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD
104313|NCT01958021|E2|Reported Event|Placebo + Letrozole 2.5mg|Matching ribociclib placebo, control drug administered orally (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 placebo QD + 2.5 mg letrozole
104314|NCT01958021|E1|Reported Event|Ribociclib 600mg + Letrozole 2.5mg|LEE011 (ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD
104315|NCT01958008|B5|Baseline|Total|Total of all reporting groups
104316|NCT01958008|B4|Baseline|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
104317|NCT01958008|B3|Baseline|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
104318|NCT01958008|B2|Baseline|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
104319|NCT01958008|B1|Baseline|Placebo|Oral administration of Placebo matching BI 113608
104320|NCT01958008|P4|Participant Flow|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
104321|NCT01958008|P3|Participant Flow|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
104322|NCT01958008|P2|Participant Flow|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
104323|NCT01958008|P1|Participant Flow|Placebo|Oral administration of Placebo matching BI 113608
104324|NCT01958008|O3|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
104325|NCT01958008|O2|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
104326|NCT01958008|O1|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
104327|NCT01958008|O3|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
104328|NCT01958008|O2|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
104329|NCT01958008|O1|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
104330|NCT01958008|O3|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
104331|NCT01958008|O2|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
104332|NCT01958008|O1|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
104333|NCT01958008|O3|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
104334|NCT01958008|O2|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
104335|NCT01958008|O1|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
104336|NCT01958008|O3|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
104337|NCT01958008|O2|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
104338|NCT01958008|O1|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
104339|NCT01958008|O3|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
104463|NCT01957579|E4|Reported Event|12 mg/kg|MEDI-551 12 mg/kg
104340|NCT01958008|O2|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
104341|NCT01958008|O1|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
104342|NCT01958008|O4|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
104343|NCT01958008|O3|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
104344|NCT01958008|O2|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
104345|NCT01958008|O1|Outcome|Placebo|Oral administration of Placebo matching BI 113608
104346|NCT01958008|E4|Reported Event|50 mg Bid|Oral administration of BI 113608 50 mg film coated tablets twice daily
104347|NCT01958008|E3|Reported Event|25 mg Bid|Oral administration of BI 113608 25 mg film coated tablets twice daily
104348|NCT01958008|E2|Reported Event|10 mg Bid|Oral administration of BI 113608 10 mg film coated tablets twice daily
104349|NCT01958008|E1|Reported Event|Placebo|Oral administration of Placebo matching BI 113608
104350|NCT01957930|B3|Baseline|Total|Total of all reporting groups
104351|NCT01957930|B2|Baseline|Standard-treatment|"Continuing with routine diabetes care~Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months"
104352|NCT01957930|B1|Baseline|Intensified Insulin Treatment|Intensified conventional insulin treatment: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.
104353|NCT01957930|P2|Participant Flow|Standard-treatment|"Continuing with routine diabetes care~Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months"
104354|NCT01957930|P1|Participant Flow|Intensified Insulin Treatment|Intensified conventional insulin treatment: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.
104355|NCT01957930|O2|Outcome|Standard-treatment|"Continuing with routine diabetes care~Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months"
104356|NCT01957930|O1|Outcome|Intensified Insulin Treatment|Intensified conventional insulin treatment: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.
104357|NCT01957930|E2|Reported Event|Standard-treatment|"Continuing with routine diabetes care~Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months"
104358|NCT01957930|E1|Reported Event|Intensified Insulin Treatment|Intensified conventional insulin treatment: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.
104359|NCT01957865|B4|Baseline|Total|Total of all reporting groups
104360|NCT01957865|B3|Baseline|Control|Real-time adherence monitoring only (no SMS)
104361|NCT01957865|B2|Baseline|Triggered SMS, Real-time Monitoring|SMS were sent for missed doses throughout the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
104362|NCT01957865|B1|Baseline|Fixed SMS, Real-time Monitoring|SMS were sent daily for one month, then weekly for two months and then after missed doses for the remainder of the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
104363|NCT01957865|P3|Participant Flow|Control|Real-time adherence monitoring only (no SMS)
104364|NCT01957865|P2|Participant Flow|Triggered SMS, Real-time Monitoring|SMS were sent for missed doses throughout the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
104365|NCT01957865|P1|Participant Flow|Fixed SMS, Real-time Monitoring|SMS were sent daily for one month, then weekly for two months and then after missed doses for the remainder of the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
104366|NCT01957865|O3|Outcome|Control|Real-time adherence monitoring only (no SMS)
104367|NCT01957865|O2|Outcome|Triggered SMS, Real-time Monitoring|"Triggered SMS, real-time monitoring: SMS reminders were sent as needed for missed doses to encourage adherence. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.~The Wisepill system automatically captured and reported each time the device was opened as a proxy for the participant's adherence"
104368|NCT01957865|O1|Outcome|Fixed SMS, Real-time Monitoring|"Fixed SMS, real-time monitoring: SMS reminders were sent daily for one month, then weekly for two months, then as needed for missed doses to encourage adherence. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.~The Wisepill system automatically captured and reported each time the device was opened as a proxy for the participant's adherence."
104369|NCT01957865|O3|Outcome|Control|Real-time adherence monitoring only (no SMS)
104370|NCT01957865|O2|Outcome|Triggered SMS, Real-time Monitoring|"Triggered SMS, real-time monitoring: SMS reminders were sent as needed for missed doses to encourage adherence. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.~The Wisepill system automatically captured and reported each time the device was opened as a proxy for the participant's adherence."
104371|NCT01957865|O1|Outcome|Fixed SMS, Real-time Monitoring|"Fixed SMS, real-time monitoring: SMS reminders were sent daily for one month, then weekly for two months, then as needed for missed doses to encourage adherence. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.~The Wisepill system automatically captured and reported each time the device was opened as a proxy for the participant's adherence."
104372|NCT01957865|E3|Reported Event|Control|Real-time adherence monitoring only (no SMS)
104464|NCT01957579|E3|Reported Event|8 mg/kg|MEDI-551 8 mg/kg
104465|NCT01957579|E2|Reported Event|4 mg/kg|MEDI-551 4 mg/kg
104466|NCT01957579|E1|Reported Event|2 mg/kg|MEDI-551 2mg/kg
104373|NCT01957865|E2|Reported Event|Triggered SMS, Real-time Monitoring|"Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.~Triggered SMS, real-time monitoring: SMS reminders were sent as needed for missed doses to encourage adherence. The Wisepill system automatically captured and reported each time the device is opened as a proxy for the participant's adherence."
104374|NCT01957865|E1|Reported Event|Fixed SMS, Real-time Monitoring|"SMS were sent daily for one month, then weekly for two months. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.~Fixed SMS, real-time monitoring: SMS reminders were sent daily for one month, then weekly for two months, then as needed for missed doses to encourage adherence. The Wisepill system automatically captured and reported each time the device is opened as a proxy for the participant's adherence."
104375|NCT01957761|B1|Baseline|Clostridium Difficile Infection|All patients with CDI between 12/2012 and 12/2013 were retrospectively reviewed.
104376|NCT01957761|P1|Participant Flow|Clostridium Difficile Infection|All patients with CDI between 12/2012 and 12/2013 were retrospectively reviewed.
104377|NCT01957761|O1|Outcome|Clostridium Difficile Infection|All patients with CDI between 12/2012 and 12/2013 were retrospectively reviewed.
104378|NCT01957761|E1|Reported Event|Clostridium Difficile Infection|
104379|NCT01957657|B1|Baseline|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
104380|NCT01957657|P1|Participant Flow|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir, immediate release tablet, plus faldaprevir, soft gelatin capsule, were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir, qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
104381|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
104382|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
104383|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
104384|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
104385|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
104386|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
104387|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
104388|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
104389|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
104467|NCT01957553|B1|Baseline|All Subjects|baseline data are summarized for all subjects
104390|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
104391|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
104392|NCT01957657|E1|Reported Event|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
104393|NCT01957579|B5|Baseline|Total|Total of all reporting groups
104394|NCT01957579|B4|Baseline|12 mg/kg|MEDI-551 12 mg/kg
104395|NCT01957579|B3|Baseline|8 mg/kg|MEDI-551 8 mg/kg
104396|NCT01957579|B2|Baseline|4 mg/kg|MEDI-551 4 mg/kg
104397|NCT01957579|B1|Baseline|2 mg/kg|MEDI-551 2mg/kg
104398|NCT01957579|P4|Participant Flow|12 mg/kg|MEDI-551 12 mg/kg
104399|NCT01957579|P3|Participant Flow|8 mg/kg|MEDI-551 8 mg/kg
104400|NCT01957579|P2|Participant Flow|4 mg/kg|MEDI-551 4 mg/kg
104401|NCT01957579|P1|Participant Flow|2 mg/kg|MEDI-551 2 mg/kg
104402|NCT01957579|O4|Outcome|12 mg/kg (MM)|MM patients in MEDI-551 12 mg/kg cohort
104403|NCT01957579|O3|Outcome|8 mg/kg (MM)|MM patients in MEDI-551 8 mg/kg cohort
104404|NCT01957579|O2|Outcome|4 mg/kg (MM)|MM patients in MEDI-551 4 mg/kg cohort
104405|NCT01957579|O1|Outcome|2 mg/kg (MM)|MM patients in MEDI-551 2 mg/kg cohort
104406|NCT01957579|O4|Outcome|12 mg/kg (CLL)|CLL patients in MEDI-551 12 mg/kg cohort
104407|NCT01957579|O3|Outcome|8 mg/kg (CLL)|CLL patients in MEDI-551 8 mg/kg cohort
104408|NCT01957579|O2|Outcome|4 mg/kg (CLL)|CLL patients in MEDI-551 4 mg/kg cohort
104409|NCT01957579|O1|Outcome|2 mg/kg (CLL)|CLL patients in MEDI-551 2 mg/kg cohort
104410|NCT01957579|O4|Outcome|12 mg/kg (DLBCL)|DLBCL patients in MEDI-551 12 mg/kg cohort
104411|NCT01957579|O3|Outcome|8 mg/kg (DLBCL)|DLBCL patients in MEDI-551 8 mg/kg cohort
104412|NCT01957579|O2|Outcome|4 mg/kg (DLBCL)|DLBCL patients in MEDI-551 4 mg/kg cohort
104413|NCT01957579|O1|Outcome|2 mg/kg (DLBCL)|DLBCL patients in MEDI-551 2 mg/kg cohort
104414|NCT01957579|O4|Outcome|12 mg/kg (FL)|FL patients in MEDI-551 12 mg/kg cohort
104415|NCT01957579|O3|Outcome|8 mg/kg (FL)|FL patients in MEDI-551 8 mg/kg cohort
104416|NCT01957579|O2|Outcome|4 mg/kg (FL)|FL patients in MEDI-551 4 mg/kg cohort
104417|NCT01957579|O1|Outcome|2 mg/kg (FL)|FL patients in MEDI-551 2 mg/kg cohort
104418|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
104419|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
104420|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
104421|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
104422|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
104423|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
104424|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
104425|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
104426|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
104427|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
104428|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
104429|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
104430|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
104431|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
104432|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
104433|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
104434|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
104435|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
104436|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
104437|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
104438|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
104439|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
104440|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
104441|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
104442|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
104443|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
104444|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
104445|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
104446|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
104447|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
104448|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
104449|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
104450|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
104451|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
104452|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
104453|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
104454|NCT01957579|O1|Outcome|MEDI-551|MEDI-551 2, 4, 8 and 12 mg/kg were evaluated
104455|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
104456|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
104457|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
104458|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
104459|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
104460|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
104461|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
104462|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
104468|NCT01957553|P2|Participant Flow|Treatment Seqence 2; First SenSura the Coloplast Test Product|"Subjects first allocated to SenSura will after cross-over test Coloplast Test product~Coloplast test product: Coloplast test product is a newly developed 2-piece ostomy appliance~SenSura: SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S"
104469|NCT01957553|P1|Participant Flow|Treatment Sequence 1, First Coloplast Test Product, the SenSur|"Subjects first allocated to Coloplast Test product will after cross-over test SenSura~Coloplast test product: Coloplast test product is a newly developed 2-piece ostomy appliance~SenSura: SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S"
104470|NCT01957553|O2|Outcome|SenSura|
104471|NCT01957553|O1|Outcome|Coloplast Test Product|
104472|NCT01957553|E2|Reported Event|SenSura|Safety data for subjects exposed to SenSura
104473|NCT01957553|E1|Reported Event|Test Product|Safety data for subjects exposed to the test product
104474|NCT01957488|B1|Baseline|All Subjects|
104475|NCT01957488|P6|Participant Flow|Test 2/Test 1/SenSura|"The subjects in this group test the following in the order described below:~Test 2~Test 1~SenSura (the comparator)~The products are single use products which in average are removed and re-applyed every1-2nd day."
104476|NCT01957488|P5|Participant Flow|Test 2/SenSura/Test 1|"The subjects in this group test the following in the order described below:~Test 2~SenSura (the comparator)~Test 1~The products are single use products which in average are removed and re-applyed every1-2nd day."
104477|NCT01957488|P4|Participant Flow|Test 1/Test 2/SenSura|"The subjects in this group test the following in the order described below:~Test 1~Test 2~SenSura (the comparator)~The products are single use products which in average are removed and re-applyed every1-2nd day."
104478|NCT01957488|P3|Participant Flow|Test 1/SenSura/Test 2|"The subjects in this group test the following in the order described below:~Test 1~SenSura (the comparator)~Test 2~The products are single use products which in average are removed and re-applyed every1-2nd day."
104479|NCT01957488|P2|Participant Flow|SenSura/Test 2/Test 1|"The subjects in this group test the following in the order described below:~SenSura (the comparator)~Test 2~Test 1~The products are single use products which in average are removed and re-applyed every1-2nd day."
104480|NCT01957488|P1|Participant Flow|SenSura/Test 1/Test 2|"The subjects in this group test the following in the order described below:~SenSura (the comparator)~Test 1~Test 2~The products are single use products which in average are removed and re-applyed every1-2nd day."
104481|NCT01957488|O3|Outcome|SenSura|Fraction of baseplates with No leakage/Seeping under the baseplate for subjects testing SenSura
104482|NCT01957488|O2|Outcome|Test 2|Fraction of baseplates with No leakage/seeping under the baseplate for subjects testing Coloplast Test 2
104483|NCT01957488|O1|Outcome|Test 1|Fraction of baseplates with No leakage/seeping under the baseplate for subjects testing Coloplast Test 1
104484|NCT01957488|E3|Reported Event|SenSura|Subjects testing SenSura
104485|NCT01957488|E2|Reported Event|Test 2|Subjects testing Coloplast Test 2
104486|NCT01957488|E1|Reported Event|Test 1|Subjects testing Coloplast Test 1
104487|NCT01957475|B1|Baseline|All Subjects|
104488|NCT01957475|P2|Participant Flow|First Coloplast Test Product Y, Then Coloplast Test Product Z|"The subjects first test test product Y and after cross-over test product Z~Coloplast Test product Y: Coloplast Test product Y is a newly developed 2-piece convex ostomy appliance~Coloplast Test product Z: Coloplast Test product Z is a newly developed 2-piece convex ostomy appliance"
104489|NCT01957475|P1|Participant Flow|First Coloplast Test Product Z; Then Coloplast Test Product Y|"The subjects first test Coloplast Test product Z and after cross-over Coloplast Test product Y~Coloplast Test product Y: Coloplast Test product Y is a newly developed 2-piece convex ostomy appliance~Coloplast Test product Z: Coloplast Test product Z is a newly developed 2-piece convex ostomy appliance"
104490|NCT01957475|O2|Outcome|Test Z|Results from the subjects testing Coloplast Test Y
104491|NCT01957475|O1|Outcome|Test Y|Results from the subjects testing Coloplast Test Y
104492|NCT01957475|E2|Reported Event|Test Z|Results from the subjects testing Coloplast Test Y
104493|NCT01957475|E1|Reported Event|Test Y|Results from the subjects testing Coloplast Test Y
104494|NCT01957462|B1|Baseline|All Subjects|
104495|NCT01957462|P2|Participant Flow|First Coloplast Test X, Then Coloplast Test V|"The subjects test the two experimental Coloplast products in a randomised order: Coloplast Test product X and after cross over Coloplast Test product V~Coloplast Test V: Coloplast Test product V is a newly developed 1-piece ostomy appliance~Coloplast Test X: Coloplast Test X is a newly developed 1-piece ostomy appliance"
104496|NCT01957462|P1|Participant Flow|FirstColplast Test V, Then Coloplast Test X|"The subject tests two experimental coloplast products in a randomised order. Coloplast Test product V and after cross over ColoplastTest product X~Coloplast Test V: Coloplast Test product V is a newly developed 1-piece ostomy appliance~Coloplast Test X: Coloplast Test X is a newly developed 1-piece ostomy appliance"
104497|NCT01957462|O2|Outcome|Test X|the results presented for the subjects testing Test X
104498|NCT01957462|O1|Outcome|Test V|The results presented for the subjects testing Coloplast Test V
104499|NCT01957462|E2|Reported Event|Test X|the results presented for the subjects testing Test X
104500|NCT01957462|E1|Reported Event|Test V|The results presented for the subjects testing Coloplast Test V
104501|NCT01957410|B1|Baseline|Ketamine IV 0.5mg/kg|Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
104502|NCT01957410|P1|Participant Flow|Ketamine IV 0.5mg/kg|Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
104631|NCT01957137|O4|Outcome|Cycling Parameter #3|Subjects received cycling parameter #3 for approximately 4 weeks.
104503|NCT01957410|O1|Outcome|Ketamine IV 0.5mg/kg|Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
104504|NCT01957410|O1|Outcome|Ketamine IV 0.5mg/kg|Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
104505|NCT01957410|E1|Reported Event|Ketamine IV 0.5mg/kg|Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
104506|NCT01957397|B1|Baseline|Overall Population|
104507|NCT01957397|P2|Participant Flow|1st Coloplast Test 2 2nd Coloplast Test 1 3rd Coloplast Test 3|"The subjects are randomised to two arms~In both arms the subjects start measuring the performance of own product to collect baseline data.~In this arm the subjects are randomised to test Coloplast Test 2 first and thereafter Coloplast Test 1~Finally the all subject test Coloplast Test 3~Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance"
104508|NCT01957397|P1|Participant Flow|1st Coloplast Test 1,2nd Coloplast Test 2 3rd Coloplast Test 3|"The subjects are randomised to two arms~In both arms the subjects start measuring the performance of own product to collect baseline data.~In this arm the subjects are randomised to test Coloplast Test1 first and thereafter Coloplast Test 2~Finally the all subject test Coloplast Test 3~Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance"
104509|NCT01957397|O4|Outcome|Baseline - Own Product|The subjects test own product to measure their baseline leakage
104510|NCT01957397|O3|Outcome|Coloplast Test 3|Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance
104511|NCT01957397|O2|Outcome|Coloplast Test 2|"The subjects are randomised to two arms~In both arms the subjects start measuring the performance of own product to collect baseline data.~In this arm the subjects are randomised to test Coloplast Test 2 first and thereafter Coloplast Test 1~Finally the all subject test Coloplast Test 3~Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance"
104512|NCT01957397|O1|Outcome|Coloplast Test 1|"The subjects are randomised to two arms~In both arms the subjects start measuring the performance of own product to collect baseline data.~In this arm the subjects are randomised to test Coloplast Test1 first and thereafter Coloplast Test 2~Finally the all subject test Coloplast Test 3~Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance"
104513|NCT01957397|E4|Reported Event|Baseline - Own Product|The subjects test own product to measure their baseline leakage
104514|NCT01957397|E3|Reported Event|Coloplast Test 3|Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance
104515|NCT01957397|E2|Reported Event|Coloplast Test 2|Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance
104516|NCT01957397|E1|Reported Event|Coloplast Test 1|Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance
104517|NCT01957384|B1|Baseline|All Subjects|
104518|NCT01957384|P6|Participant Flow|First Standard Care, Then Test Product 2, Then Test Product 1|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.~Subjects first testing Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)are randomised to secondly test~1) Coloplast Test product 2~and thereafter~1) Coloplast Test product 1"
104519|NCT01957384|P5|Participant Flow|First Standard Care, Then Test Product 1, Then Test Product 2|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.~Subjects first testing Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)are randomised to secondly test~1) Coloplast Test product 1~and thereafter~1) Coloplast Test product 2"
104520|NCT01957384|P4|Participant Flow|First Test Product 2; Then Standard Care, Then Test Product 1|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.~Subjects first testing Coloplast Test product 2 are randomised to secondly test :~1) Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)~and thereafter~1) Coloplast Test product 1"
104521|NCT01957384|P3|Participant Flow|First Test Product 2, Then Test Product 1, Then Standard Care|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.~Subjects first testing Coloplast Test product 2 are randomised to secondly test~1) Coloplast Test product 1~and thereafter~1) Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)"
104522|NCT01957384|P2|Participant Flow|First Test Product 1, Then Standard Care, Then Test Product 2|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.~Subjects first testing Coloplast Test product 1 are randomised to secondly test :~1) Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)~and thereafter~1) Coloplast Test product 2"
104632|NCT01957137|O3|Outcome|Cycling Parameter #2|Subjects received cycling parameter #2 for approximately 4 weeks.
104633|NCT01957137|O2|Outcome|Cycling Parameter #1|Subjects received cycling parameter #1 for approximately 4 weeks.
104523|NCT01957384|P1|Participant Flow|First Test Product 1, Then Test Product 2;Then Standard Care|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.~Subjects first testing Coloplast Test product 1 are randomised to secondly test :~- Coloplast Test product 2~and thereafter~- Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)and thereafter Coloplast Test product 2"
104524|NCT01957384|O3|Outcome|Standard Care|leakage data from all Standard Care baseplates
104525|NCT01957384|O2|Outcome|Coloplast Test Product 2|Leakage data from all Test 2 baseplates
104526|NCT01957384|O1|Outcome|Coloplast Test Product 1|leakage data from all Test 1 baseplates
104527|NCT01957384|E3|Reported Event|Standard Care|data from all subjects who tested Standard Care baseplates
104528|NCT01957384|E2|Reported Event|Coloplast Test Product 2|data from all subjects who tested Test 2 baseplates
104529|NCT01957384|E1|Reported Event|Coloplast Test Product 1|data from all subjects who tested Test 1 baseplates
104530|NCT01957215|B3|Baseline|Total|Total of all reporting groups
104531|NCT01957215|B2|Baseline|Placebo Patch|Placebo patch was applied on the sprained ankle BID
104532|NCT01957215|B1|Baseline|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
104533|NCT01957215|P2|Participant Flow|Placebo Patch|Placebo patch was applied on the sprained ankle BID.
104534|NCT01957215|P1|Participant Flow|Indomethacin Patch|0.35% w/w Indomethacin patch was applied on the sprained ankle twice a day (BID).
104535|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID
104536|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
104537|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID.
104538|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
104539|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID
104540|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
104541|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID.
104542|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
104543|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch to be applied on the sprained ankle BID
104544|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch to be applied on the sprained ankle BID
104545|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch to be applied on the sprained ankle BID
104546|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch to be applied on the sprained ankle BID
104547|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch to be applied on the sprained ankle BID
104548|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch to be applied on the sprained ankle BID
104549|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID
104550|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
104551|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID.
104552|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID.
104553|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch to be applied on the sprained ankle BID
104554|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch to be applied on the sprained ankle BID
104555|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID
104556|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
104557|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID
104558|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
104559|NCT01957215|E2|Reported Event|Placebo Patch|Placebo patch to be applied on the sprained ankle BID.
104560|NCT01957215|E1|Reported Event|Indomethacin Patch|Indomethacin patch to be applied on the sprained ankle twice a day (BID).
104561|NCT01957202|B1|Baseline|FF 100 μg, Levo 200 μg, FF 100 μg/Levo 200 μg, Placebo|Participants received FF 100 µg, Levo 200 µg, FF 100 μg/Levo 200 μg and placebo once daily (OD) in the morning as 2 nasal sprays (FF: 25 µg per spray, Levo: 50 μg per spray, FF/Levo: 25 μg/50 μg per spray) into each nostril for 8 days each, in a crossover design. Treatment was given in one of 18 sequences in Periods 1, 2, and 3, (with a minimum of a 14-day washout period between treatments): BCD, BAC, BCA, DAC, DCB, CDB, ADC, CAD, DCA, ACB, BDC, CBA, CBD, ACD, CAB, CDA, ABC, DBC (A, FF 100 μg; B, Levo 200 μg; C, FF 100 μg/Levo 200 μg; D, placebo). On Day 1 and Day 8 of each treatment period, participants were subjected to an allergen challenge in a Vienna Challenge Chamber (VCC) for a 4-hour period, and the assessments were conducted 12-24 hours post-dose. All participants attended a follow-up visit of 14-28 days after their last dose, and the overall duration for participation in the study (screening to follow-up) was 20 weeks.
104562|NCT01957202|P18|Participant Flow|Sequence 18: Placebo, Levo 200 μg, FF 100 μg/Levo 200 μg|Participants received placebo, Levo 200 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
104563|NCT01957202|P17|Participant Flow|Sequence 17: FF 100 μg, Levo 200 μg, FF 100 μg/Levo 200 μg|Participants received FF 100 µg, Levo 200 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
104634|NCT01957137|O1|Outcome|Continuous|Subjects received continuous stimulation for approximately 4 weeks.
104635|NCT01957137|O4|Outcome|Cycling Parameter #3|Subjects received cycling parameter #3 for approximately 4 weeks.
104636|NCT01957137|O3|Outcome|Cycling Parameter #2|Subjects received cycling parameter #2 for approximately 4 weeks.
104564|NCT01957202|P16|Participant Flow|Sequence 16: FF 100 μg/Levo 200 μg, Placebo, FF 100 μg|Participants received FF 100 μg/Levo 200 μg, placeboμg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo µg OD in the morning as 2 nasal sprays and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
104565|NCT01957202|P15|Participant Flow|Sequence 15: FF 100 μg/Levo 200 μg, FF 100 μg, Levo 200 μg|Participants received FF 100 μg/Levo 200 μg, FF 100 µg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
104566|NCT01957202|P14|Participant Flow|Sequence 14: FF 100 μg, FF 100 μg/Levo 200 μg, Placebo|Participants received FF 100 µg, FF 100 μg/Levo 200 μg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
104567|NCT01957202|P13|Participant Flow|Sequence 13: FF 100 μg/Levo 200 μg, Levo 200 μg, Placebo|Participants received FF 100 μg/Levo 200 μg, Levo 200 µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
104568|NCT01957202|P12|Participant Flow|Sequence 12: FF 100 μg/Levo 200 μg, Levo 200 μg, FF 100 μg|Participants received FF 100 μg/Levo 200 μg, Levo 200 µg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
104569|NCT01957202|P11|Participant Flow|Sequence 11: Levo 200 μg, Placebo, FF 100 μg/Levo 200 μg|Participants received Levo 200 µg, placebo and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
104570|NCT01957202|P10|Participant Flow|Sequence 10: FF 100 μg, FF 100 μg/Levo 200 μg, Levo 200 μg|Participants received FF 100 µg, FF 100 μg/Levo 200 μg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
104571|NCT01957202|P9|Participant Flow|Sequence 9: Placebo, FF 100 μg/Levo 200 μg, FF 100 μg|Participants received placebo, FF 100 μg/Levo 200 μg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
104572|NCT01957202|P8|Participant Flow|Sequence 8: FF 100 μg/Levo 200 μg, FF 100 μg, Placebo|Participants received FF 100 μg/Levo 200 μg, FF 100 µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
104573|NCT01957202|P7|Participant Flow|Sequence 7: FF 100 μg, Placebo 200 μg, FF 100 μg/Levo 200 μg|Participants received FF 100 µg, placebo and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
104574|NCT01957202|P6|Participant Flow|Sequence 6: FF 100 μg/Levo 200 μg, Placebo, Levo 200 μg|Participants received FF 100 μg/Levo 200 μg, placebo and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
104575|NCT01957202|P5|Participant Flow|Sequence 5: Placebo, FF 100 μg/Levo 200 μg, Levo 200 μg|Participants received placebo, FF 100 μg/Levo 200 μg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
104576|NCT01957202|P4|Participant Flow|Sequence 4: Placebo, FF 100 μg, FF 100 μg/Levo 200 μg|Participants received placebo, FF 100 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and FF 100 µg OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
104637|NCT01957137|O2|Outcome|Cycling Parameter #1|Subjects received cycling parameter #1 for approximately 4 weeks.
104638|NCT01957137|O1|Outcome|Continuous|Subjects received continuous stimulation for approximately 4 weeks.
104577|NCT01957202|P3|Participant Flow|Sequence 3: Levo 200 µg, FF 100 μg/Levo 200 μg, FF 100 μg|Participants received Levo 200 µg, FF 100 μg/Levo 200 μg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
104578|NCT01957202|P2|Participant Flow|Sequence 2: Levo 200 µg, FF 100 μg, FF 100 μg/Levo 200 μg|Participants received Levo 200 µg, FF 100 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
104579|NCT01957202|P1|Participant Flow|Sequence 1: Levo 200 µg, FF 100 μg/Levo 200 μg, Placebo|Participants received levocabastine (Levo) 200 micrograms (µg), fluticasone furoate (FF) 100 μg/Levo 200 μg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg once daily (OD) in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
104580|NCT01957202|O4|Outcome|FF 100 μg/Levo 200 μg|Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
104581|NCT01957202|O3|Outcome|Levo 200 μg|Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
104582|NCT01957202|O2|Outcome|FF 100 μg|Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
104583|NCT01957202|O1|Outcome|Placebo|Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
104584|NCT01957202|O4|Outcome|FF 100 μg/Levo 200 μg|Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
104585|NCT01957202|O3|Outcome|Levo 200 μg|Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
104586|NCT01957202|O2|Outcome|FF 100 μg|Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
104587|NCT01957202|O1|Outcome|Placebo|Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
104588|NCT01957202|O4|Outcome|FF 100 μg/Levo 200 μg|Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
104589|NCT01957202|O3|Outcome|Levo 200 μg|Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
104590|NCT01957202|O2|Outcome|FF 100 μg|Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
104591|NCT01957202|O1|Outcome|Placebo|Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
104592|NCT01957202|O4|Outcome|FF 100 μg/Levo 200 μg|Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
104593|NCT01957202|O3|Outcome|Levo 200 μg|Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
104594|NCT01957202|O2|Outcome|FF 100 μg|Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
104595|NCT01957202|O1|Outcome|Placebo|Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
104596|NCT01957202|E4|Reported Event|FF 100 μg/Levo 200 μg|Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
104597|NCT01957202|E3|Reported Event|Levo 200 μg|Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
104598|NCT01957202|E2|Reported Event|FF 100 μg|Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
104599|NCT01957202|E1|Reported Event|Placebo|Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
104600|NCT01957163|B4|Baseline|Total|Total of all reporting groups
104601|NCT01957163|B3|Baseline|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 125 µg administered via a DPI in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
104602|NCT01957163|B2|Baseline|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 62.5 µg administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
104603|NCT01957163|B1|Baseline|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI, followed by one inhalation of UMEC matching placebo, administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
104604|NCT01957163|P3|Participant Flow|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
104639|NCT01957137|E5|Reported Event|No Stimulation|Subjects received no stimulation for approximately 4 weeks.
104640|NCT01957137|E4|Reported Event|Cycling Parameter #3|Subjects received Cycling Parameter #3 for approximately 4 weeks.
104641|NCT01957137|E3|Reported Event|Cycling Parameter #2|Subjects received Cycling Parameter #2 for approximately 4 weeks.
104605|NCT01957163|P2|Participant Flow|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
104606|NCT01957163|P1|Participant Flow|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
104607|NCT01957163|O3|Outcome|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 125 µg administered via a DPI in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
104608|NCT01957163|O2|Outcome|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 62.5 µg administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
104609|NCT01957163|O1|Outcome|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI, followed by one inhalation of UMEC matching placebo, administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
104610|NCT01957163|O3|Outcome|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 125 µg administered via a DPI in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
104611|NCT01957163|O2|Outcome|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 62.5 µg administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
104612|NCT01957163|O1|Outcome|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI, followed by one inhalation of UMEC matching placebo, administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
104613|NCT01957163|E3|Reported Event|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 125 µg administered via a DPI in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
104614|NCT01957163|E2|Reported Event|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 62.5 µg administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
104615|NCT01957163|E1|Reported Event|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI, followed by one inhalation of UMEC matching placebo, administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
104616|NCT01957137|B1|Baseline|Subjects Who First Finished Unique Randomization Sequences|Baseline descriptions provided were based on 24 subjects who first finished unique randomization sequences, which are those subjects included in the primary analysis of the primary outcome.
104617|NCT01957137|P1|Participant Flow|All Study Participants|Thirty subjects were randomized to 1 of 24 sequences with 4 cycling settings: 2 subjects discontinued early with 1 due to an AE, and 1 due to consent withdrawal. Twenty-eight subjects completed the randomization sequences . After that all subjects went through no stimulation for approximately 4 weeks, which was not part of randomization.
104618|NCT01957137|O1|Outcome|No Stimulation|Following the randomized portion of the study, all subjects went through no stimulation for approximately 4 weeks.
104619|NCT01957137|O1|Outcome|No Stimulation|Following the randomized portion of the study, all subjects went through no stimulation for approximately 4 weeks.
104620|NCT01957137|O1|Outcome|No Stimulation|Following the randomized portion of the study, all subjects went through no stimulation for approximately 4 weeks.
104621|NCT01957137|O1|Outcome|No Stimulation|Following the randomized portion of the study, all subjects went through no stimulation for approximately 4 weeks.
104622|NCT01957137|O1|Outcome|No Stimulation|Following the randomized portion of the study, all subjects went through no stimulation for approximately 4 weeks.
104623|NCT01957137|O4|Outcome|Cycling Parameter #3|Subjects received cycling parameter #3 for approximately 4 weeks.
104624|NCT01957137|O3|Outcome|Cycling Parameter #2|Subjects received cycling parameter #2 for approximately 4 weeks.
104625|NCT01957137|O2|Outcome|Cycling Parameter #1|Subjects received cycling parameter #1 for approximately 4 weeks.
104626|NCT01957137|O1|Outcome|Continuous|Subjects received continuous stimulation for approximately 4 weeks.
104627|NCT01957137|O4|Outcome|Cycling Parameter #3|Subjects received cycling parameter #3 for approximately 4 weeks.
104628|NCT01957137|O3|Outcome|Cycling Parameter #2|Subjects received cycling parameter #2 for approximately 4 weeks.
104629|NCT01957137|O2|Outcome|Cycling Parameter #1|Subjects received cycling parameter #1 for approximately 4 weeks.
104630|NCT01957137|O1|Outcome|Continuous|Subjects received continuous stimulation for approximately 4 weeks.
104642|NCT01957137|E2|Reported Event|Cycling Parameter #1|Subjects received Cycling Parameter #1 for approximately 4 weeks.
104643|NCT01957137|E1|Reported Event|Continuous|Subjects received continuous stimulation for approximately 4 weeks.
104644|NCT01957111|B3|Baseline|Total|Total of all reporting groups
104645|NCT01957111|B2|Baseline|Good Sleepers|To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
104646|NCT01957111|B1|Baseline|Individuals With Insomnia|Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
104647|NCT01957111|P2|Participant Flow|Good Sleepers|To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
104648|NCT01957111|P1|Participant Flow|Individuals With Insomnia|Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
104649|NCT01957111|O2|Outcome|Good Sleepers|To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
104650|NCT01957111|O1|Outcome|Individuals With Insomnia|Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
104651|NCT01957111|O2|Outcome|Good Sleepers|To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
104652|NCT01957111|O1|Outcome|Individuals With Insomnia|Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
104653|NCT01957111|E2|Reported Event|Good Sleepers|To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
104654|NCT01957111|E1|Reported Event|Individuals With Insomnia|Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
104655|NCT01956435|B1|Baseline|All Participants|All Study Participants
104656|NCT01956435|P2|Participant Flow|Excimer Light Treatment Left Leg, Control Right Leg|Excimer light treatment will be performed on patients randomized to receive treatment on the left leg and right leg will be untreated control
104657|NCT01956435|P1|Participant Flow|Excimer Light Treatment Right Leg, Control Left Leg|Excimer light treatment will be performed on patients randomized to receive treatment on the right leg and left leg will be untreated control
104658|NCT01956435|O1|Outcome|All Patients|All study patients
104659|NCT01956435|O2|Outcome|Control|Lesions not treated with excimer light
104660|NCT01956435|O1|Outcome|Excimer Light Treatment|Lesions treated with excimer light
104661|NCT01956435|E2|Reported Event|Control|Lesions not treated with excimer light
104662|NCT01956435|E1|Reported Event|Excimer Light Treatment|Lesions treated with excimer light
104663|NCT01956240|B3|Baseline|Total|Total of all reporting groups
104664|NCT01956240|B2|Baseline|Subjects With Shoulder Pain|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
104665|NCT01956240|B1|Baseline|Asymptomatic Subjects|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
104666|NCT01956240|P2|Participant Flow|Subjects With Shoulder Pain|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
104667|NCT01956240|P1|Participant Flow|Asymptomatic Subjects|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
104668|NCT01956240|O2|Outcome|Subjects With Shoulder Pain|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
104669|NCT01956240|O1|Outcome|Asymptomatic Subjects|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
104670|NCT01956240|O2|Outcome|Subjects With Shoulder Pain|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
104671|NCT01956240|O1|Outcome|Asymptomatic Subjects|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
104672|NCT01956240|E2|Reported Event|Subjects With Shoulder Pain|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
104673|NCT01956240|E1|Reported Event|Asymptomatic Subjects|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
104674|NCT01956097|B4|Baseline|Total|Total of all reporting groups
104675|NCT01956097|B3|Baseline|Placebo|"Placebo~Placebo"
104676|NCT01956097|B2|Baseline|HX106 1180mg|"HX106 1180mg/day~HX106 1180mg"
104677|NCT01956097|B1|Baseline|HX106 590mg|"HX106 590mg/day~HX106 590mg"
104678|NCT01956097|P3|Participant Flow|Placebo|"Placebo~Placebo"
104679|NCT01956097|P2|Participant Flow|HX106 1180mg|"HX106 1180mg/day~HX106 1180mg"
104680|NCT01956097|P1|Participant Flow|HX106 590mg|"HX106 590mg/day~HX106 590mg"
104681|NCT01956097|O3|Outcome|Placebo|"Placebo~Placebo"
104682|NCT01956097|O2|Outcome|HX106 1180mg|"HX106 1180mg/day~HX106 1180mg"
104683|NCT01956097|O1|Outcome|HX106 590mg|"HX106 590mg/day~HX106 590mg"
104684|NCT01956097|O3|Outcome|Placebo|"Placebo~Placebo"
104685|NCT01956097|O2|Outcome|HX106 1180mg|"HX106 1180mg/day~HX106 1180mg"
104686|NCT01956097|O1|Outcome|HX106 590mg|"HX106 590mg/day~HX106 590mg"
104687|NCT01956097|O3|Outcome|Placebo|"Placebo~Placebo"
104688|NCT01956097|O2|Outcome|HX106 1180mg|"HX106 1180mg/day~HX106 1180mg"
104689|NCT01956097|O1|Outcome|HX106 590mg|"HX106 590mg/day~HX106 590mg"
104690|NCT01956097|O3|Outcome|Placebo|"Placebo~Placebo"
104691|NCT01956097|O2|Outcome|HX106 1180mg|"HX106 1180mg/day~HX106 1180mg"
104692|NCT01956097|O1|Outcome|HX106 590mg|"HX106 590mg/day~HX106 590mg"
104693|NCT01956097|E3|Reported Event|Placebo|"Placebo~Placebo"
104694|NCT01956097|E2|Reported Event|HX106 1180mg|"HX106 1180mg/day~HX106 1180mg"
104695|NCT01956097|E1|Reported Event|HX106 590mg|"HX106 590mg/day~HX106 590mg"
104696|NCT01956032|B1|Baseline|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104697|NCT01956032|P1|Participant Flow|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104810|NCT01955720|O5|Outcome|220 mg/Plc. 5g HS 45-64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/plc. 5g.
104811|NCT01955720|O4|Outcome|220 mg/5g HS 45-64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g.
104698|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104699|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104700|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104701|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104702|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104703|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104704|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104705|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104706|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104707|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104708|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104709|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104710|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104711|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104712|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104713|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104714|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104715|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104716|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104717|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104718|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104719|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104812|NCT01955720|O3|Outcome|220 mg/2.5g HS 45-64 Yrs Re-exposure|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
107840|NCT01943292|O1|Outcome|Defactinib 200 mg Bid|200 mg po bid defactinib
104720|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104721|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104722|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104723|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104724|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104725|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104726|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104727|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104728|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104729|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104730|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104731|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104732|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104733|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104734|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104735|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104736|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104737|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104738|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104739|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104740|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104741|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104813|NCT01955720|O2|Outcome|220 mg/Plc. 2.5g HS 45−64 Years|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/ placebo(plc.) 2.5g.
104814|NCT01955720|O1|Outcome|220 mg/2.5g HS 45−64 Years|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
104742|NCT01956032|E1|Reported Event|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
104743|NCT01955954|B1|Baseline|Canary Breathing System|"Treatment with Canary Breathing System~Canary Breathing System: The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns."
104744|NCT01955954|P1|Participant Flow|Canary Breathing System|"Treatment with Canary Breathing System~Canary Breathing System: The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns."
104745|NCT01955954|O1|Outcome|Canary Breathing System|"Treatment with Canary Breathing System~Canary Breathing System: The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns."
104746|NCT01955954|O1|Outcome|Canary Breathing System|"Treatment with Canary Breathing System~Canary Breathing System: The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns."
104747|NCT01955954|O1|Outcome|Canary Breathing System|"Treatment with Canary Breathing System~Canary Breathing System: The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns."
104748|NCT01955954|O1|Outcome|Canary Breathing System|"Treatment with Canary Breathing System~Canary Breathing System: The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns."
104749|NCT01955954|O1|Outcome|Canary Breathing System|"Treatment with Canary Breathing System~Canary Breathing System: The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns."
104750|NCT01955954|O1|Outcome|Canary Breathing System|"Treatment with Canary Breathing System~Canary Breathing System: The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns."
104751|NCT01955954|E1|Reported Event|Canary Breathing System|"Treatment with Canary Breathing System~Canary Breathing System: The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns."
104752|NCT01955733|B4|Baseline|Total|Total of all reporting groups
104753|NCT01955733|B3|Baseline|MabThera From 1301.1|The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
104754|NCT01955733|B2|Baseline|Rituxan From 1301.1|The Rituxan from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
104755|NCT01955733|B1|Baseline|BI 695500|"The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by intravenous infusion. Two 1000 mg infusions were separated by 2 weeks.~Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders."
104756|NCT01955733|P3|Participant Flow|MabThera From 1301.1|The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
104757|NCT01955733|P2|Participant Flow|Rituxan From 1301.1|The Rituxan from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
104758|NCT01955733|P1|Participant Flow|BI 695500|"The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by intravenous infusion. Two 1000 mg infusions were separated by 2 weeks.~Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders."
104759|NCT01955733|O3|Outcome|MabThera From 1301.1|The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
104760|NCT01955733|O2|Outcome|Rituxan From 1301.1|The Rituxan from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
104761|NCT01955733|O1|Outcome|BI 695500|"The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by intravenous infusion. Two 1000 mg infusions were separated by 2 weeks.~Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders."
104762|NCT01955733|O3|Outcome|MabThera From 1301.1|The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
104763|NCT01955733|O2|Outcome|Rituxan From 1301.1|The Rituxan from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
104764|NCT01955733|O1|Outcome|BI 695500|"The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by intravenous infusion. Two 1000 mg infusions were separated by 2 weeks.~Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders."
104765|NCT01955733|O3|Outcome|MabThera From 1301.1|The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
104766|NCT01955733|O2|Outcome|Rituxan From 1301.1|The Rituxan from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
104767|NCT01955733|O1|Outcome|BI 695500|"The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by intravenous infusion. Two 1000 mg infusions were separated by 2 weeks.~Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders."
104768|NCT01955733|O3|Outcome|MabThera From 1301.1|The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
104769|NCT01955733|O2|Outcome|Rituxan From 1301.1|The Rituxan from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
104815|NCT01955720|O15|Outcome|150 mg /Plc. 2*2.5g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused as 2 doses of each plc. 2.5g, given 1 h apart.
104770|NCT01955733|O1|Outcome|BI 695500|"The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by intravenous infusion. Two 1000 mg infusions were separated by 2 weeks.~Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders."
104771|NCT01955733|O3|Outcome|MabThera From 1301.1|The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
104772|NCT01955733|O2|Outcome|Rituxan From 1301.1|The Rituxan from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
104773|NCT01955733|O1|Outcome|BI 695500|"The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by intravenous infusion. Two 1000 mg infusions were separated by 2 weeks.~Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders."
104774|NCT01955733|E3|Reported Event|MabThera From 1301.1|The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
104775|NCT01955733|E2|Reported Event|Rituxan From 1301.1|The Rituxan from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
104776|NCT01955733|E1|Reported Event|BI 695500|The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by intravenous infusion. Two 1000 mg infusions were separated by 2 weeks. Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders.
104777|NCT01955720|B1|Baseline|Total Subjects Group|The total subjects group contains the following sub-groups: high dose (5 g idarucizumab), healthy, aged 45-64 yrs: high dose (5 g idarucizumab), healthy elderly, aged 65-80 yrs: high dose (5 g idarucizumab), mild renal impairment (RI), aged 45-80 yrs: high dose (2.5 g + 2.5 g idarucizumab), with moderate RI, aged 45-80 yrs: medium dose (2.5 g idarucizumab), healthy, aged 45-64 yrs: low dose (1 g idarucizumab), healthy elderly, aged 65-80 yrs: low dose (1 g idarucizumab), with mild RI, aged 45-80 yrs.
104778|NCT01955720|P6|Participant Flow|Placebo / 1 Ida|Subjects received dabigatran (DE) 220 mg plus placebo 1g followed by dabigatran 220 mg plus Ida 1g (low dose)
104779|NCT01955720|P5|Participant Flow|1 Ida / Placebo|Subjects received dabigatran (DE) 220 mg plus Ida 1g followed by dabigatran 220 mg plus placebo 1g (low dose)
104780|NCT01955720|P4|Participant Flow|Placebo / 2.5 Ida|Subjects received dabigatran (DE) 220 mg plus placebo 2.5g followed by dabigatran 220 mg plus Ida 2.5g (medium dose)
104781|NCT01955720|P3|Participant Flow|2.5 Ida / Placebo|Subjects received dabigatran (DE) 220 mg plus Ida 2.5g followed by dabigatran 220 mg plus placebo 2.5g (medium dose)
104782|NCT01955720|P2|Participant Flow|Placebo / 5 Ida|Subjects received dabigatran (DE) 220 mg plus placebo 5g followed by dabigatran 220 mg plus Ida 5g (high dose)
104783|NCT01955720|P1|Participant Flow|5 Ida / Placebo|Subjects received dabigatran (DE) 220 mg plus idarucizumab (Ida) 5g followed by dabigatran 220 mg plus placebo 5g (high dose)
104784|NCT01955720|O8|Outcome|150 mg /2*2.5 g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused 2 doses of each Ida 2.5g, given 1 h apart.
104785|NCT01955720|O7|Outcome|150 mg/5 g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
104786|NCT01955720|O6|Outcome|150 mg/1 g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 1g
104787|NCT01955720|O5|Outcome|220 mg/5 g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
104788|NCT01955720|O4|Outcome|220 mg/1 g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
104789|NCT01955720|O3|Outcome|220 mg/5 g HS 45-64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g.
104790|NCT01955720|O2|Outcome|220 mg/2.5 g HS 45-64 Yrs Re-exposure|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
104791|NCT01955720|O1|Outcome|220 mg/2.5 g HS 45−64 Years|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
104792|NCT01955720|O8|Outcome|150 mg /2*2.5 g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused 2 doses of each Ida 2.5g, given 1 h apart.
104793|NCT01955720|O7|Outcome|150 mg/5 g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
104794|NCT01955720|O6|Outcome|150 mg/1 g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 1g
104795|NCT01955720|O5|Outcome|220 mg/5 g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
104796|NCT01955720|O4|Outcome|220 mg/1 g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
104797|NCT01955720|O3|Outcome|220 mg/5 g HS 45-64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g.
104798|NCT01955720|O2|Outcome|220 mg/2.5 g HS 45-64 Yrs Re-exposure|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
104799|NCT01955720|O1|Outcome|220 mg/2.5 g HS 45−64 Years|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
104800|NCT01955720|O15|Outcome|150 mg /Plc. 2*2.5g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused as 2 doses of each plc. 2.5g, given 1 h apart.
104801|NCT01955720|O14|Outcome|150 mg /2*2.5g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused as 2 doses of each Ida 2.5g, given 1 h apart.
104802|NCT01955720|O13|Outcome|150 mg/Plc. 5g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/plc. 5g
104803|NCT01955720|O12|Outcome|150 mg/5g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
104804|NCT01955720|O11|Outcome|150 mg/Plc. 1g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/plc. 1g
104805|NCT01955720|O10|Outcome|150 mg/1g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 1g
104806|NCT01955720|O9|Outcome|220 mg/Plc. 5g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 5g.
104807|NCT01955720|O8|Outcome|220 mg/5g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
104808|NCT01955720|O7|Outcome|220 mg/Plc. 1g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 1g.
104809|NCT01955720|O6|Outcome|220 mg/1g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
104909|NCT01955564|O5|Outcome|Cohort 5|NW-3509a 20mg, single dose
104816|NCT01955720|O14|Outcome|150 mg /2*2.5g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused as 2 doses of each Ida 2.5g, given 1 h apart.
104817|NCT01955720|O13|Outcome|150 mg/Plc. 5g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/plc. 5g
104818|NCT01955720|O12|Outcome|150 mg/5g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
104819|NCT01955720|O11|Outcome|150 mg/Plc. 1g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/plc. 1g
104820|NCT01955720|O10|Outcome|150 mg/1g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 1g
104821|NCT01955720|O9|Outcome|220 mg/Plc. 5g HS 65-80 Yrs|Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 5g.
104822|NCT01955720|O8|Outcome|220 mg/5g HS 65-80 Yrs|Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
104823|NCT01955720|O7|Outcome|220 mg/Plc. 1g HS 65-80 Yrs|Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 1g.
104824|NCT01955720|O6|Outcome|220 mg/1g HS 65-80 Yrs|Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
104825|NCT01955720|O5|Outcome|220 mg/Plc. 5g HS 45-64 Yrs|Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/plc. 5g.
104826|NCT01955720|O4|Outcome|220 mg/5g HS 45-64 Yrs|Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g
104827|NCT01955720|O3|Outcome|220 mg/2.5g HS 45-64 Yrs Re-exposure|Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
104828|NCT01955720|O2|Outcome|220 mg/Plc. 2.5g HS 45−64 Years|Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/ placebo(plc.) 2.5g.
104829|NCT01955720|O1|Outcome|220 mg/2.5g HS 45−64 Years|Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
104830|NCT01955720|O8|Outcome|150 mg /2*2.5 g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused 2 doses of each Ida 2.5g, given 1 h apart.
104831|NCT01955720|O7|Outcome|150 mg/5 g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
104832|NCT01955720|O6|Outcome|150 mg/1 g Mild Renal Impairment (RI)|Mild RI (creatinine clearance [CL] 60-90) with dabigatran (DE) 150 mg/Ida 1g
104833|NCT01955720|O5|Outcome|220 mg/5 g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
104834|NCT01955720|O4|Outcome|220 mg/1 g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
104835|NCT01955720|O3|Outcome|220 mg/5 g HS 45-64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g.
104836|NCT01955720|O2|Outcome|220 mg/2.5 g HS 45-64 Yrs Re-exposure|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
104837|NCT01955720|O1|Outcome|220 mg/2.5 g HS 45−64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
104838|NCT01955720|O1|Outcome|On Treatment Group|during the treatment period.
104839|NCT01955720|O2|Outcome|Idarucizumab (Ida)|Idarucizumab (Ida).
104840|NCT01955720|O1|Outcome|Placebo|idarucizumab-matching placebo
104841|NCT01955720|E7|Reported Event|High (5g) Placebo Dose|Subjects with high (5g) placebo dose treatment
104842|NCT01955720|E6|Reported Event|Medium (2.5g) Placebo Dose|Subjects with medium (2.5g) placebo dose treatment
104843|NCT01955720|E5|Reported Event|Low (1g) Placebo Dose|Subjects with low (1g) placebo dose treatment
104844|NCT01955720|E4|Reported Event|High (5g) Idarucizumab Dose|Subjects with high (5g) idarucizumab dose treatment
104845|NCT01955720|E3|Reported Event|Medium (2.5g) Idarucizumab Dose|Subjects with medium (2.5g) idarucizumab dose treatment
104846|NCT01955720|E2|Reported Event|Low (1g) Idarucizumab Dose|Subjects with low 1g idarucizumab dose treatment
104847|NCT01955720|E1|Reported Event|Dabigatran Etexilate (DE)|subjects with Dabigatran etexilate (DE) treatment
104848|NCT01955707|B3|Baseline|Total|Total of all reporting groups
104849|NCT01955707|B2|Baseline|Natalizumab|300 mg single IV injection of natalizumab
104850|NCT01955707|B1|Baseline|Placebo|A single IV injection of placebo
104851|NCT01955707|P2|Participant Flow|Natalizumab|300 mg single IV injection of natalizumab
104852|NCT01955707|P1|Participant Flow|Placebo|A single intravenous (IV) injection of placebo
104853|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
104854|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
104855|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
104856|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
104857|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
104858|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
104859|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
104860|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
104861|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
104862|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
104863|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
104864|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
104865|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
104866|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
104867|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
104868|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
104869|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
104870|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
104871|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
104872|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
104873|NCT01955707|E2|Reported Event|Natalizumab|300 mg single IV injection of natalizumab
104874|NCT01955707|E1|Reported Event|Placebo|A single IV injection of placebo
104910|NCT01955564|O4|Outcome|Cohort 4|NW-3509a 10mg, single dose
104911|NCT01955564|O3|Outcome|Cohort 3|NW-3509a 5mg, single dose
104912|NCT01955564|O2|Outcome|Cohort 2|NW-3509a 2mg, single dose
104875|NCT01955629|B1|Baseline|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
104876|NCT01955629|P1|Participant Flow|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg intravenous (IV) infusion every 3 weeks (q3w) in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant’s refusal of further treatment.
104877|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
104878|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
104879|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
104880|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
104881|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
104882|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
104883|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
104884|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
104885|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
104886|NCT01955629|E1|Reported Event|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg intravenous(IV) infusion every 3 weeks (q3w) in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant’s refusal of further treatment.
104887|NCT01955564|B8|Baseline|Total|Total of all reporting groups
104888|NCT01955564|B7|Baseline|Cohort 6|NW-3509a 30 mg NW-3509a: single dose
104889|NCT01955564|B6|Baseline|Cohort 5|"NW-3509a 20 mg~NW-3509a: single dose"
104890|NCT01955564|B5|Baseline|Cohort 4|"NW-3509a 10 mg~NW-3509a: single dose"
104891|NCT01955564|B4|Baseline|Cohort 3|"NW-3509a 5mg~NW-3509a: single dose"
104892|NCT01955564|B3|Baseline|Cohort 2|"NW-3509a 2mg~NW-3509a: single dose"
104893|NCT01955564|B2|Baseline|Cohort 1|"NW-3509a - 1mg~NW-3509a: single dose"
104894|NCT01955564|B1|Baseline|Placebo|placebo: single dose
104895|NCT01955564|P7|Participant Flow|Cohort 6|NW-3509a 30 mg, single dose
104896|NCT01955564|P6|Participant Flow|Cohort 5|NW-3509a 20 mg, single dose
104897|NCT01955564|P5|Participant Flow|Cohort 4|NW-3509a 10 mg, single dose
104898|NCT01955564|P4|Participant Flow|Cohort 3|NW-3509a 5mg, single dose
104899|NCT01955564|P3|Participant Flow|Cohort 2|NW-3509a 2mg, single dose
104900|NCT01955564|P2|Participant Flow|Cohort 1|NW-3509a - 1mg, single dose
104901|NCT01955564|P1|Participant Flow|Placebo|Placebo, single dose
104902|NCT01955564|O6|Outcome|Cohort 6|NW-3509a 30mg, single dose
104903|NCT01955564|O5|Outcome|Cohort 5|NW-3509a 20mg, single dose
104904|NCT01955564|O4|Outcome|Cohort 4|NW-3509a 10mg, single dose
104905|NCT01955564|O3|Outcome|Cohort 3|NW-3509a 5mg, single dose
104906|NCT01955564|O2|Outcome|Cohort 2|NW-3509a 2mg, single dose
104907|NCT01955564|O1|Outcome|Cohort 1|NW-3509a 1mg, single dose
104908|NCT01955564|O6|Outcome|Cohort 6|NW-3509a 30mg, single dose
104929|NCT01955473|B5|Baseline|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104930|NCT01955473|B4|Baseline|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104931|NCT01955473|B3|Baseline|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104932|NCT01955473|B2|Baseline|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104933|NCT01955473|B1|Baseline|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104934|NCT01955473|P5|Participant Flow|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104935|NCT01955473|P4|Participant Flow|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104936|NCT01955473|P3|Participant Flow|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104937|NCT01955473|P2|Participant Flow|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104938|NCT01955473|P1|Participant Flow|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104939|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104940|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104941|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104942|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104943|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104944|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104945|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104946|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104947|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104948|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104949|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104950|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104951|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104952|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104953|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104954|NCT01955473|O2|Outcome|Part A and B Combined|All subjects who were included in Part A and Part B. Sym004 administered by intravenous infusion at a dose of 6 mg/kg weekly, or 9 mg/kg at Week 1 followed by a maintenance dose of 6 mg/kg weekly, or 12 mg/kg weekly, or 18 mg/kg biweekly in Part A or 12 mg/kg by intravenous infusion weekly in Part B until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104955|NCT01955473|O1|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104956|NCT01955473|O2|Outcome|Part A and B Combined|All subjects who were included in Part A and Part B. Sym004 administered by intravenous infusion at a dose of 6 mg/kg weekly, or 9 mg/kg at Week 1 followed by a maintenance dose of 6 mg/kg weekly, or 12 mg/kg weekly, or 18 mg/kg biweekly in Part A or 12 mg/kg by intravenous infusion weekly in Part B until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104957|NCT01955473|O1|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104958|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104959|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104960|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104961|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104962|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104963|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104964|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104965|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104966|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104967|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104968|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104969|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104970|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104971|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104972|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104973|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104974|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104975|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104976|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104977|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104978|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104979|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104980|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104981|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104982|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104983|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104984|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104985|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104986|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104987|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104988|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104989|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104990|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104991|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104992|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104993|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104994|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104995|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104996|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104997|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104998|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
104999|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105000|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105001|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105002|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105003|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105004|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105005|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105006|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105007|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105008|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105009|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105010|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105011|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105012|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105013|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105014|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105015|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105016|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105017|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105018|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105019|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105020|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105021|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105022|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105023|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105024|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105025|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105026|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105027|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105028|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105029|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105030|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105031|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105032|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105033|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105034|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105035|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105036|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105037|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105038|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105039|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105040|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105041|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105042|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105043|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105044|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105045|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105046|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105047|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105048|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105049|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105050|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105051|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105052|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105053|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105054|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105055|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105056|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105057|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105058|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105059|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105060|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105061|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105062|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105063|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105064|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105065|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105066|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105067|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105068|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105069|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105070|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105071|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105072|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105073|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105074|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105075|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105076|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105077|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105078|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105079|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105080|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105081|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105082|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105083|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105084|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105085|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105086|NCT01955473|E5|Reported Event|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105087|NCT01955473|E4|Reported Event|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105088|NCT01955473|E3|Reported Event|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105089|NCT01955473|E2|Reported Event|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105090|NCT01955473|E1|Reported Event|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
105091|NCT01955434|B1|Baseline|Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)|Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
105092|NCT01955434|P1|Participant Flow|Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)|Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
105124|NCT01955161|O2|Outcome|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
105125|NCT01955161|O1|Outcome|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
105093|NCT01955434|O1|Outcome|Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)|Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
105094|NCT01955434|O1|Outcome|Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)|Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
105095|NCT01955434|O1|Outcome|Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)|Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
105096|NCT01955434|O1|Outcome|Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)|Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
105097|NCT01955434|O1|Outcome|Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)|Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
105098|NCT01955434|E1|Reported Event|Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)|Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
105099|NCT01955382|B3|Baseline|Total|Total of all reporting groups
105100|NCT01955382|B2|Baseline|AS Only (Water)|All children in the AS Only group will receive artesunate (AS) 2.4 mg/kg IV at 0, 12, 24, and 48 h, and weight-based volumes of clean water at 0, 6, 12, and 18 h. All children will then receive age-based doses of amodiaquine.
105101|NCT01955382|B1|Baseline|AS + oAC|All children in the AS+oAC group will receive artesunate (AS) 2.4 mg/kg IV at 0, 12, 24, and 48 h, and weight-based doses of oral activated charcoal (oAC; Actidose Aqua; according to Table 1) at 0, 6, 12, and 18 h. All children will then receive age-based doses of amodiaquine.
105102|NCT01955382|P2|Participant Flow|AS Only (Water)|"Children in the AS only group will receive a weight-based volume of clean water (Bottled Water) to drink rather than the oAC.~Artesunate: Artesunate (AS) obtained from Guilin Pharma (Shanghai), the only pharmaceutical company GMP pre-qualified by the WHO. The product artesunate for injection + 5% sodium carbonate inj + 0.9% sodium chloride inj will be delivered in vials of 30 mg and 60- mg vials, respectively, and will be dosed at 2.4 mg/kg as recommended for SM treatment by the WHO~Amodiaquine: Amodiaquine obtained from Pfizer (Dakar), is provided as 200-mg tablets or syrup (50 10 mg/mL), and will be provided as age-based doses per the manufacturer's directions."
105103|NCT01955382|P1|Participant Flow|AS + oAC|"All children will receive Artesunate (AS) 2.4 mg/kg IV at 0 and 12 h, 24 h, and 48 h. Children in the AS+oAC group will be given weight-based doses of oAC (Actidose Aqua) (Table 1) at 0, 6, 12, and 18 h. All children will then receive amodiaquine.~Actidose Aqua: Actidose Aqua (oAC, Paddock Laboratories) is sold over the counter in the US in bottles containing 25 g/120 mL (NDC # 0574-0121-04) or 50 g/240 mL (NDC # 0574-0121-08). oAC is stable at room temperature.~Artesunate: Artesunate (AS) obtained from Guilin Pharma (Shanghai), the only pharmaceutical company GMP pre-qualified by the WHO. The product artesunate for injection + 5% sodium carbonate inj + 0.9% sodium chloride inj will be delivered in vials of 30 mg and 60- mg vials, respectively, and will be dosed at 2.4 mg/kg as recommended for SM treatment by the WHO~Amodiaquine: Amodiaquine obtained from Pfizer (Dakar), is provided as 200-mg tablets or syrup (50 10 mg/mL), and will be provided as age-based doses."
105104|NCT01955382|O2|Outcome|AS Only (Water)|"Children in the AS only group will receive a weight-based volume of clean water (Bottled Water) to drink rather than the oAC.~Artesunate: Artesunate (AS) obtained from Guilin Pharma (Shanghai), the only pharmaceutical company GMP pre-qualified by the WHO. The product artesunate for injection + 5% sodium carbonate inj + 0.9% sodium chloride inj will be delivered in vials of 30 mg and 60- mg vials, respectively, and will be dosed at 2.4 mg/kg as recommended for SM treatment by the WHO~Amodiaquine: Amodiaquine obtained from Pfizer (Dakar), is provided as 200-mg tablets or syrup (50 10 mg/mL), and will be provided as age-based doses per the manufacturer's directions."
105126|NCT01955161|O3|Outcome|Idalopirdine 60 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
105127|NCT01955161|O2|Outcome|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
105128|NCT01955161|O1|Outcome|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
105129|NCT01955161|O3|Outcome|Idalopirdine 60 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
105130|NCT01955161|O2|Outcome|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
105131|NCT01955161|O1|Outcome|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
105105|NCT01955382|O1|Outcome|AS + oAC|"All children will receive Artesunate (AS) 2.4 mg/kg IV at 0 and 12 h, 24 h, and 48 h. Children in the AS+oAC group will be given weight-based doses of oAC (Actidose Aqua) (Table 1) at 0, 6, 12, and 18 h. All children will then receive amodiaquine.~Actidose Aqua: Actidose Aqua (oAC) (Paddock Laboratories is sold over the counter in the US in bottles containing 25 g/120 mL (NDC # 0574-0121-04) or 50 g/240 mL (NDC # 0574-0121-08). oAC is stable at room temperature.~Artesunate: Artesunate (AS) obtained from Guilin Pharma (Shanghai), the only pharmaceutical company GMP pre-qualified by the WHO. The product artesunate for injection + 5% sodium carbonate inj + 0.9% sodium chloride inj will be delivered in vials of 30 mg and 60- mg vials, respectively, and will be dosed at 2.4 mg/kg as recommended for SM treatment by the WHO~Amodiaquine: Amodiaquine obtained from Pfizer (Dakar), is provided as 200-mg tablets or syrup (50 10 mg/mL), and will be provided as age-based doses."
105106|NCT01955382|O2|Outcome|AS Only (Water)|"Children in the AS only group will receive a weight-based volume of clean water (Bottled Water) to drink rather than the oAC.~Artesunate: Artesunate (AS) obtained from Guilin Pharma (Shanghai), the only pharmaceutical company GMP pre-qualified by the WHO. The product artesunate for injection + 5% sodium carbonate inj + 0.9% sodium chloride inj will be delivered in vials of 30 mg and 60- mg vials, respectively, and will be dosed at 2.4 mg/kg as recommended for SM treatment by the WHO~Amodiaquine: Amodiaquine obtained from Pfizer (Dakar), is provided as 200-mg tablets or syrup (50 10 mg/mL), and will be provided as age-based doses per the manufacturer's directions."
105107|NCT01955382|O1|Outcome|AS + oAC|"All children will receive Artesunate (AS) 2.4 mg/kg IV at 0 and 12 h, 24 h, and 48 h. Children in the AS+oAC group will be given weight-based doses of oAC (Actidose Aqua) (Table 1) at 0, 6, 12, and 18 h. All children will then receive amodiaquine.~Actidose Aqua: Actidose Aqua (oAC, Paddock Laboratories) is sold over the counter in the US in bottles containing 25 g/120 mL (NDC # 0574-0121-04) or 50 g/240 mL (NDC # 0574-0121-08). oAC is stable at room temperature.~Artesunate: Artesunate (AS) obtained from Guilin Pharma (Shanghai), the only pharmaceutical company GMP pre-qualified by the WHO. The product artesunate for injection + 5% sodium carbonate inj + 0.9% sodium chloride inj will be delivered in vials of 30 mg and 60- mg vials, respectively, and will be dosed at 2.4 mg/kg as recommended for SM treatment by the WHO~Amodiaquine: Amodiaquine obtained from Pfizer (Dakar), is provided as 200-mg tablets or syrup (50 10 mg/mL), and will be provided as age-based doses."
105108|NCT01955382|E2|Reported Event|AS Only (Water)|"Children in the AS only group will receive a weight-based volume of clean water (Bottled Water) to drink rather than the oAC.~Artesunate: Artesunate (AS) obtained from Guilin Pharma (Shanghai), the only pharmaceutical company GMP pre-qualified by the WHO. The product artesunate for injection + 5% sodium carbonate inj + 0.9% sodium chloride inj will be delivered in vials of 30 mg and 60- mg vials, respectively, and will be dosed at 2.4 mg/kg as recommended for SM treatment by the WHO~Amodiaquine: Amodiaquine obtained from Pfizer (Dakar), is provided as 200-mg tablets or syrup (50 10 mg/mL), and will be provided as age-based doses per the manufacturer's directions."
105109|NCT01955382|E1|Reported Event|AS + oAC|"All children will receive Artesunate (AS) 2.4 mg/kg IV at 0 and 12 h, 24 h, and 48 h. Children in the AS+oAC group will be given weight-based doses of oAC (Actidose Aqua) (Table 1) at 0, 6, 12, and 18 h. All children will then receive amodiaquine.~Actidose Aqua: Actidose Aqua (oAC) (Paddock Laboratories is sold over the counter in the US in bottles containing 25 g/120 mL (NDC # 0574-0121-04) or 50 g/240 mL (NDC # 0574-0121-08). oAC is stable at room temperature.~Artesunate: Artesunate (AS) obtained from Guilin Pharma (Shanghai), the only pharmaceutical company GMP pre-qualified by the WHO. The product artesunate for injection + 5% sodium carbonate inj + 0.9% sodium chloride inj will be delivered in vials of 30 mg and 60- mg vials, respectively, and will be dosed at 2.4 mg/kg as recommended for SM treatment by the WHO~Amodiaquine: Amodiaquine obtained from Pfizer (Dakar), is provided as 200-mg tablets or syrup (50 10 mg/mL), and will be provided as age-based doses."
105110|NCT01955369|B1|Baseline|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
105111|NCT01955369|P1|Participant Flow|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
105112|NCT01955369|O1|Outcome|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
105113|NCT01955369|O1|Outcome|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
105114|NCT01955369|O1|Outcome|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
105115|NCT01955369|E1|Reported Event|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
105116|NCT01955161|B4|Baseline|Total|Total of all reporting groups
105117|NCT01955161|B3|Baseline|Idalopirdine 60 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
105118|NCT01955161|B2|Baseline|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
105119|NCT01955161|B1|Baseline|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
105120|NCT01955161|P3|Participant Flow|Idalopirdine 60 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
105121|NCT01955161|P2|Participant Flow|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
105122|NCT01955161|P1|Participant Flow|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
105123|NCT01955161|O3|Outcome|Idalopirdine 60 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
105132|NCT01955161|O3|Outcome|Idalopirdine 60 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
105133|NCT01955161|O2|Outcome|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
105134|NCT01955161|O1|Outcome|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
105135|NCT01955161|O3|Outcome|Idalopirdine 60 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
105136|NCT01955161|O2|Outcome|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
105137|NCT01955161|O1|Outcome|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
105138|NCT01955161|O3|Outcome|Idalopirdine 60 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
105139|NCT01955161|O2|Outcome|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
105140|NCT01955161|O1|Outcome|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
105141|NCT01955161|O3|Outcome|Idalopirdine 60 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
105142|NCT01955161|O2|Outcome|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
105143|NCT01955161|O1|Outcome|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
105144|NCT01955161|O3|Outcome|Idalopirdine 60 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
105145|NCT01955161|O2|Outcome|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
105146|NCT01955161|O1|Outcome|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
105147|NCT01955161|O3|Outcome|Idalopirdine 60 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
105148|NCT01955161|O2|Outcome|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
105149|NCT01955161|O1|Outcome|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
105150|NCT01955161|O3|Outcome|Idalopirdine 60 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
105151|NCT01955161|O2|Outcome|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
105152|NCT01955161|O1|Outcome|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
105153|NCT01955161|O3|Outcome|Idalopirdine 60 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
105154|NCT01955161|O2|Outcome|Idalopirdine 30 mg|"Idalopirdine adjunct to 10 mg Donepezil~Idalopirdine: Once daily, encapsulated tablets, orally"
105155|NCT01955161|O1|Outcome|Placebo|"Placebo adjunct to 10 mg Donepezil~Placebo: Once daily, matching placebo capsules, orally"
105156|NCT01955161|E3|Reported Event|Idalopirdine 60 mg|Idalopirdine adjunct to 10 mg Donezepil
105157|NCT01955161|E2|Reported Event|Idalopirdine 30 mg|Idalopirdine adjunct to 10 mg Donezepil
105158|NCT01955161|E1|Reported Event|Placebo|Placebo adjunct to 10 mg Donepezil
105159|NCT01955122|B3|Baseline|Total|Total of all reporting groups
105160|NCT01955122|B2|Baseline|Group B|Tandem Colonoscopy: Each patient will undergo a double procedure: EndoRings™ colonoscopy followed by Standard colonoscopy (without using the EndoRings™ add-on device) .
105161|NCT01955122|B1|Baseline|Group A|Tandem Colonoscopy: Each patient will undergo a double procedure: Standard colonoscopy (without using the EndoRings™ add-on device) followed by EndoRings™ colonoscopy.
105162|NCT01955122|P2|Participant Flow|Group B|"Tandem Colonoscopy: Each patient will undergo 2 colonoscopy procedures:~an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy."
105163|NCT01955122|P1|Participant Flow|Group A|"Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:~a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy."
105164|NCT01955122|O2|Outcome|Group B|"Tandem Colonoscopy: Each patient will undergo 2 colonoscopy procedures:~an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy."
105165|NCT01955122|O1|Outcome|Group A|"Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:~a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy."
105166|NCT01955122|O2|Outcome|Group B|"Tandem Colonoscopy: Each patient will undergo 2 colonoscopy procedures:~an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy."
105167|NCT01955122|O1|Outcome|Group A|"Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:~a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy."
105168|NCT01955122|O2|Outcome|Group B|"Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:~an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy.~Tandem Colonoscopy: Each patient will undergo a double procedure: standard colonoscopy using the EndoRings™ add-on device and Standard colonoscopy (without using the EndoRings™ add-on device) in a randomized order."
105169|NCT01955122|O1|Outcome|Group A|"Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:~a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy.~Tandem Colonoscopy: Each patient will undergo a double procedure: standard colonoscopy using the EndoRings™ add-on device and Standard colonoscopy (without using the EndoRings™ add-on device) in a randomized order."
105170|NCT01955122|O2|Outcome|Group B|Tandem Colonoscopy: Each patient will undergo a double procedure: EndoRings™ colonoscopy followed by Standard colonoscopy (without using the EndoRings™ add-on device).
105171|NCT01955122|O1|Outcome|Group A|Tandem Colonoscopy: Each patient will undergo a double procedure: Standard colonoscopy (without using the EndoRings™ add-on device) followed by EndoRings™ colonoscopy.
105172|NCT01955122|O2|Outcome|Standard Colonoscopy|procedures performed with the Standard
105173|NCT01955122|O1|Outcome|EndoRings Colonoscopy|procedures performed with the EndoRings
105174|NCT01955122|O2|Outcome|Group B|"Tandem Colonoscopy: Each patient will undergo 2 colonoscopy procedures:~an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy."
105175|NCT01955122|O1|Outcome|Group A|"Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:~a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy."
105176|NCT01955122|O2|Outcome|Group B|"Tandem Colonoscopy: Each patient will undergo 2 colonoscopy procedures:~an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy."
105177|NCT01955122|O1|Outcome|Group A|"Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:~a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy."
105178|NCT01955122|E2|Reported Event|Group B (Control Group)|Tandem Colonoscopy: Each patient will undergo a double procedure: EndoRings™ colonoscopy followed by Standard colonoscopy (without using the EndoRings™ add-on device).
105179|NCT01955122|E1|Reported Event|A (Study Group)|Tandem Colonoscopy: Each patient will undergo a double procedure: Standard colonoscopy (without using the EndoRings™ add-on device) followed by EndoRings™ colonoscopy.
105180|NCT01955083|B3|Baseline|Total|Total of all reporting groups
105181|NCT01955083|B2|Baseline|Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring."
105182|NCT01955083|B1|Baseline|Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring."
105183|NCT01955083|P2|Participant Flow|Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Subjects receive pillar implant of the soft palate under local anesthesia as an outpatient procedure on sitting position. Using the delivery tool of the pillar implant system, the mucosa of the soft palate close to the hard palate-soft palate junction (approximate 0.5 cm) was punctured in the midline. The needle was inserted to the uvular muscle and moved parallel to the curve of the soft palate towards the tip of the uvula. After reaching the insertion point, the implant was delivered steadily after which the needle was withdrawn. This process was repeated for the second and third implants in the bilateral para-midline with a 0.2 cm horizontal distance from the first implant."
105184|NCT01955083|P1|Participant Flow|Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Subjects receive radiofrequency under local anesthesia as an outpatient procedure on sitting position. radiofrequency energy was delivered via a generator (Somnus® Model S2, Gyrus-ACMI Corporation, Maple Grove, MN, USA) with the power set to 10 watts and the maximal target temperature to 85°C. The needle electrode was inserted through the mucosa into the muscle layer at the entry points (approximately 1 cm below the hard palate-soft palate junction). The electrode was kept in place until 600 J had been delivered at the midline and 300 J at both para-midline sites (approximately 1 cm horizontal distance)."
105185|NCT01955083|O2|Outcome|Percentage of Good Response at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percentage of good response at 3 months after surgery was calculated."
105186|NCT01955083|O1|Outcome|Percentage of Good Response at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percentage of good response was calculated."
105187|NCT01955083|O2|Outcome|Percent Change in B1-Fmean at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Fmean (Hz) before and at 3 months after surgery was calculated."
105188|NCT01955083|O1|Outcome|Percent Change in B1-Fmean at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Fmean (Hz) before and at 3 months after surgery was calculated."
105189|NCT01955083|O2|Outcome|Percent Change in B1-Fpeak at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Fpeak (Hz) before and at 3 months after surgery was calculated."
105190|NCT01955083|O1|Outcome|Percent Change in B1-Fpeak at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Fpeak (Hz) before and at 3 months after surgery was calculated."
105191|NCT01955083|O2|Outcome|Percent Change in B1-Imean at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Imean (dB) before and at 3 months after surgery was calculated."
105192|NCT01955083|O1|Outcome|Percent Change in B1-Imean at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Imean (dB) before and at 3 months after surgery was calculated."
105193|NCT01955083|O2|Outcome|Percent Change in B1-Imax at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Imax (dB) before and at 3 months after surgery was calculated."
105194|NCT01955083|O1|Outcome|Percent Change in B1-Imax at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Imax (dB) before and at 3 months after surgery was calculated."
105195|NCT01955083|O2|Outcome|Percent Change in B1-SI at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-SI (event/hour) before and at 3 months after surgery was calculated."
105196|NCT01955083|O1|Outcome|Percent Change in B1-SI at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-SI (event/hour) before and at 3 months after surgery was calculated."
105228|NCT01955044|E1|Reported Event|"High Dose LCPUFA"|"the high dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
105229|NCT01955005|B3|Baseline|Total|Total of all reporting groups
105197|NCT01955083|O2|Outcome|Percent Change in Total-Fmean at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Fmean (Hz) before and at 3 months after surgery was calculated."
105198|NCT01955083|O1|Outcome|Percent Change in Total-Fmean at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Fmean (Hz) before and at 3 months after surgery was calculated."
105199|NCT01955083|O2|Outcome|Percent Change in Total-Fpeak at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Fpeak (Hz) before and at 3 months after surgery was calculated."
105200|NCT01955083|O1|Outcome|Percent Change in Total-Fpeak at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Fpeak (Hz) before and at 3 months after surgery was calculated."
105201|NCT01955083|O2|Outcome|Percent Change in Total-Imean at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Imean (dB) before and at 3 months after surgery was calculated."
105202|NCT01955083|O1|Outcome|Percent Change in Total-Imean at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Imean (dB) before and at 3 months after surgery was calculated."
105203|NCT01955083|O2|Outcome|Percent Change in Total-Imax at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Imax (dB) before and at 3 months after surgery was calculated."
105204|NCT01955083|O1|Outcome|Percent Change in Total-Imax at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Imax (dB) before and at 3 months after surgery was calculated."
105205|NCT01955083|O2|Outcome|Percent Change in Total-SI at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-SI (event/hour) before and at 3 months after surgery was calculated."
105206|NCT01955083|O1|Outcome|Percent Change in Total-SI at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-SI (event/hour) before and at 3 months after surgery was calculated."
105207|NCT01955083|O2|Outcome|Change in SOS Score at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Mean change (after value-before value) in SOS score at 3 months after surgery was calculated."
105208|NCT01955083|O1|Outcome|Change in SOS Score at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Mean change (after value-before value) in SOS score at 3 months after surgery was calculated."
105209|NCT01955083|O2|Outcome|Change in VAS Score at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Mean change (after value-before value) in VAS score at 3 months after surgery was calculated."
105210|NCT01955083|O1|Outcome|Change in VAS Score at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Mean change (after value-before value) in VAS score at 3 months after surgery was calculated."
105211|NCT01955083|E2|Reported Event|Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring."
105212|NCT01955083|E1|Reported Event|Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring."
105213|NCT01955044|B4|Baseline|Total|Total of all reporting groups
105214|NCT01955044|B3|Baseline|Placebo|"the placebo is a drop that will be administered to ELBW infants.~placebo"
105215|NCT01955044|B2|Baseline|"Low Dose LCPUFA"|"the low dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
105216|NCT01955044|B1|Baseline|"High Dose LCPUFA"|"the high dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
105217|NCT01955044|P3|Participant Flow|Placebo|"the placebo is a drop that will be administered to ELBW infants.~placebo"
105218|NCT01955044|P2|Participant Flow|"Low Dose LCPUFA"|"the low dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
105219|NCT01955044|P1|Participant Flow|"High Dose LCPUFA"|"the high dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
105220|NCT01955044|O3|Outcome|Placebo|"the placebo is a drop that will be administered to ELBW infants.~placebo"
105221|NCT01955044|O2|Outcome|"Low Dose LCPUFA"|"the low dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
105222|NCT01955044|O1|Outcome|"High Dose LCPUFA"|"the high dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
105223|NCT01955044|O3|Outcome|Placebo|"the placebo is a drop that will be administered to ELBW infants.~placebo"
105224|NCT01955044|O2|Outcome|"Low Dose LCPUFA"|"the low dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
105225|NCT01955044|O1|Outcome|"High Dose LCPUFA"|"the high dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
105226|NCT01955044|E3|Reported Event|Placebo|"the placebo is a drop that will be administered to ELBW infants.~placebo"
105227|NCT01955044|E2|Reported Event|"Low Dose LCPUFA"|"the low dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
105230|NCT01955005|B2|Baseline|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.~Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
105231|NCT01955005|B1|Baseline|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.~My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
105232|NCT01955005|P2|Participant Flow|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.~Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
105233|NCT01955005|P1|Participant Flow|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.~My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
105234|NCT01955005|O2|Outcome|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.~Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
105235|NCT01955005|O1|Outcome|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.~My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
105236|NCT01955005|O2|Outcome|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.~Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
105237|NCT01955005|O1|Outcome|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.~My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
105238|NCT01955005|O2|Outcome|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.~Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
105239|NCT01955005|O1|Outcome|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.~My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
105240|NCT01955005|E2|Reported Event|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.~Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
105241|NCT01955005|E1|Reported Event|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.~My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
105242|NCT01954771|B4|Baseline|Total|Total of all reporting groups
105243|NCT01954771|B3|Baseline|SMBG-7 Group|"Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~SMBG~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
105244|NCT01954771|B2|Baseline|SMBG-4 Group|"Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~SMBG~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
105245|NCT01954771|B1|Baseline|Control Group|"Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~SMBG~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
105246|NCT01954771|P3|Participant Flow|SMBG-7 Group|"Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~SMBG~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
105247|NCT01954771|P2|Participant Flow|SMBG-4 Group|"Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~SMBG~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
105248|NCT01954771|P1|Participant Flow|Control Group|"Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~SMBG~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
105249|NCT01954771|O3|Outcome|SMBG-7 Group|"SMBG: Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
105250|NCT01954771|O2|Outcome|SMBG-4 Group|"SMBG: Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
105251|NCT01954771|O1|Outcome|Control Group|"SMBG: Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
105252|NCT01954771|O3|Outcome|SMBG-7 Group|"Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~SMBG~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
105253|NCT01954771|O2|Outcome|SMBG-4 Group|"Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~SMBG~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
105254|NCT01954771|O1|Outcome|Control Group|"Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~SMBG~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
105255|NCT01954771|O3|Outcome|SMBG-7 Group|"SMBG: Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
105256|NCT01954771|O2|Outcome|SMBG-4 Group|"SMBG: Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
105257|NCT01954771|O1|Outcome|Control Group|"SMBG: Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
105258|NCT01954771|O3|Outcome|SMBG-7 Group|"SMBG: Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
105259|NCT01954771|O2|Outcome|SMBG-4 Group|"SMBG: Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
105271|NCT01954628|B3|Baseline|Total|Total of all reporting groups
105272|NCT01954628|B2|Baseline|Placebo|"1 x Placebo capsule daily~Placebo: Placebo control"
105273|NCT01954628|B1|Baseline|AQX-1125 (200 mg)|"1 x AQX-1125 capsule daily~AQX-1125: Synthetic SHIP1 activator"
105260|NCT01954771|O1|Outcome|Control Group|"SMBG: Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
105261|NCT01954771|E3|Reported Event|SMBG-7 Group|"Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~SMBG~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
105262|NCT01954771|E2|Reported Event|SMBG-4 Group|"Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~SMBG~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
105263|NCT01954771|E1|Reported Event|Control Group|"Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.~SMBG~CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
105264|NCT01954745|B1|Baseline|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.~Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
105265|NCT01954745|P1|Participant Flow|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.~Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
105266|NCT01954745|O1|Outcome|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.~Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
105267|NCT01954745|O1|Outcome|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.~Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
105268|NCT01954745|O1|Outcome|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.~Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
105269|NCT01954745|O1|Outcome|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.~Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
105270|NCT01954745|E1|Reported Event|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.~Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
105274|NCT01954628|P2|Participant Flow|Placebo|Placebo (matching AQX-1125 capsule), oral, once daily for 12 weeks. Placebo control. All standard of care treatments for COPD were permitted throughout the study with the exception of Roflumilast and Theophylline.
105275|NCT01954628|P1|Participant Flow|AQX-1125 (200 mg)|AQX-1125 (200 mg capsule), oral once daily for 12 weeks. All standard of care treatments for COPD were permitted throughout the study with the exception of Roflumilast and Theophylline.
105276|NCT01954628|O3|Outcome|AQX-1125 Week 12|Week 12 PK Week 12 PK
105277|NCT01954628|O2|Outcome|AQX-1125 Week 4|AQX-1125 Week 4 PK
105278|NCT01954628|O1|Outcome|AQX-1125 Week 2|AQX-1125 Week 2 PK
105279|NCT01954628|O2|Outcome|Placebo|1 x Placebo capsule daily
105280|NCT01954628|O1|Outcome|AQX-1125 (200mg)|1 x AQX-1125 capsule daily
105281|NCT01954628|O2|Outcome|Placebo|1 x Placebo capsule daily
105282|NCT01954628|O1|Outcome|AQX-1125 (200 mg)|1 x AQX-1125 capsule daily
105283|NCT01954628|O2|Outcome|Placebo|1 x Placebo capsule daily
105284|NCT01954628|O1|Outcome|AQX-1125 (200 mg)|1 x AQX-1125 capsule daily
105285|NCT01954628|O2|Outcome|Placebo|1 x Placebo capsule daily
105286|NCT01954628|O1|Outcome|AQX-1125 (200 mg)|1 x AQX-1125 capsule daily
105287|NCT01954628|O2|Outcome|Placebo|1 x Placebo capsule daily
105288|NCT01954628|O1|Outcome|AQX-1125 (200 mg)|1 x AQX-1125 capsule daily
105289|NCT01954628|O2|Outcome|Placebo|1 x Placebo capsule daily
105290|NCT01954628|O1|Outcome|AQX-1125 (200mg)|1 x AQX-1125 capsule daily
105291|NCT01954628|E2|Reported Event|Placebo|"1 x Placebo capsule daily~Placebo: Placebo control"
105292|NCT01954628|E1|Reported Event|AQX-1125|"1 x AQX-1125 capsule daily~AQX-1125: Synthetic SHIP1 activator"
105293|NCT01954251|B3|Baseline|Total|Total of all reporting groups
105294|NCT01954251|B2|Baseline|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
105295|NCT01954251|B1|Baseline|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
105296|NCT01954251|P2|Participant Flow|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
105297|NCT01954251|P1|Participant Flow|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
105298|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
105299|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
105300|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
105301|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
105302|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
105303|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
105304|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
105305|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
105306|NCT01954251|O1|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
105307|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
105308|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
105309|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
107841|NCT01943292|E3|Reported Event|Defactinib 600 mg Bid|600 mg po bid defactinib
105310|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
105311|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
105312|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
105313|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
105314|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
105315|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
105316|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
105317|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
105318|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
105319|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
105320|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
105321|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
105322|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
105323|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
105324|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
105325|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
105326|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
105327|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
105328|NCT01954251|E2|Reported Event|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
105329|NCT01954251|E1|Reported Event|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
105330|NCT01954160|B3|Baseline|Total|Total of all reporting groups
105331|NCT01954160|B2|Baseline|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
105332|NCT01954160|B1|Baseline|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
105333|NCT01954160|P2|Participant Flow|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
105334|NCT01954160|P1|Participant Flow|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
105335|NCT01954160|O2|Outcome|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
105336|NCT01954160|O1|Outcome|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
105337|NCT01954160|O2|Outcome|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
105338|NCT01954160|O1|Outcome|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
105339|NCT01954160|O2|Outcome|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
105340|NCT01954160|O1|Outcome|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
105341|NCT01954160|O2|Outcome|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
105342|NCT01954160|O1|Outcome|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
105343|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
105344|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
105345|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
105346|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
105347|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
105348|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
105349|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
105350|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
105351|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
105352|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
105353|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
105354|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
105355|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
105356|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
105357|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
105358|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
105359|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
105360|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
105361|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
105362|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
105363|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
105364|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
105365|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
105366|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
105367|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
105368|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
105369|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
105370|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
105371|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
105372|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
105373|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
105374|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
105375|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
105376|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
105377|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
105378|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
105379|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
105380|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
105381|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
105382|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
105383|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
105384|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
105385|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
105386|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
105387|NCT01954160|O2|Outcome|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
105388|NCT01954160|O1|Outcome|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
105389|NCT01954160|E2|Reported Event|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
105390|NCT01954160|E1|Reported Event|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
105391|NCT01954121|B3|Baseline|Total Title|
105392|NCT01954121|B2|Baseline|Carbamazepine-IR (Safety Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
105393|NCT01954121|B1|Baseline|Levetiracetam (Safety Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
105394|NCT01954121|P2|Participant Flow|Carbamazepine-IR|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
105395|NCT01954121|P1|Participant Flow|Levetiracetam|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
105396|NCT01954121|O2|Outcome|Carbamazepine-IR (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
105397|NCT01954121|O1|Outcome|Levetiracetam (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
105463|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
105398|NCT01954121|O2|Outcome|Carbamazepine-IR (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
105399|NCT01954121|O1|Outcome|Levetiracetam (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
105400|NCT01954121|O2|Outcome|Carbamazepine-IR (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
105401|NCT01954121|O1|Outcome|Levetiracetam (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
105402|NCT01954121|O2|Outcome|Carbamazepine-IR (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
105403|NCT01954121|O1|Outcome|Levetiracetam (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
105404|NCT01954121|O2|Outcome|Carbamazepine-IR (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
105405|NCT01954121|O1|Outcome|Levetiracetam (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
105406|NCT01954121|E2|Reported Event|Carbamazepine-IR (Safety Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
105407|NCT01954121|E1|Reported Event|Levetiracetam (Safety Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
105408|NCT01953874|B3|Baseline|Total|Total of all reporting groups
105409|NCT01953874|B2|Baseline|OMT Only|"Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105410|NCT01953874|B1|Baseline|MV ASV+OMT|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105411|NCT01953874|P2|Participant Flow|OMT Only|"Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105412|NCT01953874|P1|Participant Flow|MV ASV+OMT|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105413|NCT01953874|O2|Outcome|OMT Only|"Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105414|NCT01953874|O1|Outcome|MV ASV+OMT|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105415|NCT01953874|O2|Outcome|OMT Only|"Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105416|NCT01953874|O1|Outcome|MV ASV+OMT|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105417|NCT01953874|O2|Outcome|OMT Only|"Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105418|NCT01953874|O1|Outcome|MV ASV+OMT|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105419|NCT01953874|O2|Outcome|OMT Only|"Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105420|NCT01953874|O1|Outcome|MV ASV+OMT|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105421|NCT01953874|O2|Outcome|OMT Only|"Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105422|NCT01953874|O1|Outcome|MV ASV+OMT|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105423|NCT01953874|O2|Outcome|OMT Only|"Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105424|NCT01953874|O1|Outcome|MV ASV+OMT|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105425|NCT01953874|O2|Outcome|OMT Only|"Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105426|NCT01953874|O1|Outcome|MV ASV+OMT|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105427|NCT01953874|O2|Outcome|OMT Only|"Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105428|NCT01953874|O1|Outcome|MV ASV+OMT|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105429|NCT01953874|O2|Outcome|OMT Only|"Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105430|NCT01953874|O1|Outcome|MV ASV+OMT|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105431|NCT01953874|O1|Outcome|All Subjects|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment compared to optimized medical treatment only~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105432|NCT01953874|O2|Outcome|OMT Only|"Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105433|NCT01953874|O1|Outcome|MV ASV+OMT|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105434|NCT01953874|O2|Outcome|OMT Only|"Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105435|NCT01953874|O1|Outcome|MV ASV+OMT|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105436|NCT01953874|O2|Outcome|OMT Only|"Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105437|NCT01953874|O1|Outcome|MV ASV+OMT|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105438|NCT01953874|O2|Outcome|OMT Only|"Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
107842|NCT01943292|E2|Reported Event|Defactinib 400 mg Bid|400 mg po bid defactinib
105439|NCT01953874|O1|Outcome|MV ASV+OMT|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105440|NCT01953874|O2|Outcome|OMT Only|"Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105441|NCT01953874|O1|Outcome|MV ASV+OMT|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105442|NCT01953874|O2|Outcome|OMT Only|"Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105443|NCT01953874|O1|Outcome|MV ASV+OMT|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105444|NCT01953874|O2|Outcome|OMT Only|"Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105445|NCT01953874|O1|Outcome|MV ASV+OMT|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105446|NCT01953874|O2|Outcome|OMT Only|"Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105447|NCT01953874|O1|Outcome|MV ASV+OMT|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105448|NCT01953874|O2|Outcome|OMT Only|"Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105449|NCT01953874|O1|Outcome|MV ASV+OMT|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105450|NCT01953874|O2|Outcome|OMT Only|"Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105451|NCT01953874|O1|Outcome|MV ASV+OMT|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105452|NCT01953874|E2|Reported Event|OMT Only|"Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105453|NCT01953874|E1|Reported Event|MV ASV+OMT|"Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment~MV ASV: Minute ventilation-targeted servo-ventilation therapy.~Optimized Medical Treatment: Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated"
105454|NCT01953354|B3|Baseline|Total|Total of all reporting groups
105455|NCT01953354|B2|Baseline|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
105456|NCT01953354|B1|Baseline|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
105457|NCT01953354|P2|Participant Flow|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
105458|NCT01953354|P1|Participant Flow|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
105459|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
105460|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
105461|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
105462|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
105464|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
105465|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
105466|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
105467|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
105468|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
105469|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
105470|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
105471|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
105472|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
105473|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
105474|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
105475|NCT01953354|E2|Reported Event|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
105476|NCT01953354|E1|Reported Event|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
105477|NCT01953328|B9|Baseline|Total|Total of all reporting groups
105478|NCT01953328|B8|Baseline|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105479|NCT01953328|B7|Baseline|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105480|NCT01953328|B6|Baseline|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
105481|NCT01953328|B5|Baseline|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105482|NCT01953328|B4|Baseline|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105483|NCT01953328|B3|Baseline|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105484|NCT01953328|B2|Baseline|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105485|NCT01953328|B1|Baseline|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105486|NCT01953328|P8|Participant Flow|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105487|NCT01953328|P7|Participant Flow|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105488|NCT01953328|P6|Participant Flow|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
105489|NCT01953328|P5|Participant Flow|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105490|NCT01953328|P4|Participant Flow|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105491|NCT01953328|P3|Participant Flow|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105492|NCT01953328|P2|Participant Flow|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105493|NCT01953328|P1|Participant Flow|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105494|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105495|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105496|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
107843|NCT01943292|E1|Reported Event|Defactinib 200 mg Bid|200 mg po bid defactinib
105497|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105498|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105499|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105500|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105501|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105502|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105503|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105504|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
105505|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105506|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105507|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105508|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105509|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105510|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105511|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105512|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
105513|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105514|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105515|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105516|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105517|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105518|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105519|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105520|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
105521|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105522|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105523|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105524|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105525|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105526|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105527|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105528|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
105529|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105530|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105531|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105532|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105533|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105534|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105535|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105536|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
105537|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105538|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105539|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105540|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105541|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105542|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105543|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105544|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
105545|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105546|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105547|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105548|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105549|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105550|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105551|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105552|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
105553|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105554|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105555|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105556|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105557|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105558|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105559|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105560|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
105561|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105562|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105563|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105564|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105565|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105566|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105567|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105568|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
105569|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105570|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105571|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105572|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105573|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105574|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105575|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105576|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
105577|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105578|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105579|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105580|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105581|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105582|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105583|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105584|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
105585|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105586|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105587|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105588|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105589|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105590|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105591|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105592|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
105593|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105594|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105595|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105596|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105597|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105598|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105599|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105600|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
105601|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105602|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105603|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105604|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105605|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105606|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105607|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105608|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
105609|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105610|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105611|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105612|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105613|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105614|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105615|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105616|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
105617|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105618|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105619|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105620|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105621|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105622|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105623|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105624|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
105625|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105626|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105627|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105628|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105629|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105630|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105631|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105632|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
105633|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105634|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105635|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105636|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105637|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105638|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105639|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105640|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
105641|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105642|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105643|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105644|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105645|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105646|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105647|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105648|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
105649|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105650|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105651|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105652|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105653|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105654|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105655|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105656|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
105657|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105658|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105659|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105660|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105661|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105662|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105663|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105664|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
105665|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105666|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105667|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105668|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105669|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105670|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105671|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105672|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
105673|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105674|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105675|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105676|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105677|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105678|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105679|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105680|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
105681|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105682|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105683|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105684|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105685|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105686|NCT01953328|E8|Reported Event|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105687|NCT01953328|E7|Reported Event|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105688|NCT01953328|E6|Reported Event|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
105689|NCT01953328|E5|Reported Event|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
105690|NCT01953328|E4|Reported Event|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
105691|NCT01953328|E3|Reported Event|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
105692|NCT01953328|E2|Reported Event|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
105693|NCT01953328|E1|Reported Event|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
105694|NCT01953237|B3|Baseline|Total|Total of all reporting groups
105695|NCT01953237|B2|Baseline|MedActive|Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.
105696|NCT01953237|B1|Baseline|Control|Individuals randomized to the control condition will be provided with a smartphone free of charge with unlimited use of the phone's voice and internet capabilities. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period. All participants will be contacted by research staff to trouble-shoot problems with the smartphone at the end of the first week, but will receive no additional contact from research staff until the end of the trial.
105697|NCT01953237|P2|Participant Flow|MedActive|Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.
105698|NCT01953237|P1|Participant Flow|Control|Individuals randomized to the control condition will be provided with a smartphone free of charge with unlimited use of the phone's voice and internet capabilities. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period. All participants will be contacted by research staff to trouble-shoot problems with the smartphone at the end of the first week, but will receive no additional contact from research staff until the end of the trial.
105699|NCT01953237|O2|Outcome|MedActive|Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.
105752|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
107000|NCT01947517|O2|Outcome|Superflex Group|"Randomized to receive Group B punctal plugs~Superflex Punctal Occluder"
105700|NCT01953237|O1|Outcome|Control|Individuals randomized to the control condition will be provided with a smartphone free of charge with unlimited use of the phone's voice and internet capabilities. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period. All participants will be contacted by research staff to trouble-shoot problems with the smartphone at the end of the first week, but will receive no additional contact from research staff until the end of the trial.
105701|NCT01953237|E2|Reported Event|MedActive|Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.
105702|NCT01953237|E1|Reported Event|Control|Individuals randomized to the control condition will be provided with a smartphone free of charge with unlimited use of the phone's voice and internet capabilities. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period. All participants will be contacted by research staff to trouble-shoot problems with the smartphone at the end of the first week, but will receive no additional contact from research staff until the end of the trial.
105703|NCT01953081|B3|Baseline|Total|Total of all reporting groups
105704|NCT01953081|B2|Baseline|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
105705|NCT01953081|B1|Baseline|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
105706|NCT01953081|P2|Participant Flow|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
105707|NCT01953081|P1|Participant Flow|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
105708|NCT01953081|O2|Outcome|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
105709|NCT01953081|O1|Outcome|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
105710|NCT01953081|O2|Outcome|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
105711|NCT01953081|O1|Outcome|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
105712|NCT01953081|O2|Outcome|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
105713|NCT01953081|O1|Outcome|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
105714|NCT01953081|O2|Outcome|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
105715|NCT01953081|O1|Outcome|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
105716|NCT01953081|O2|Outcome|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
105717|NCT01953081|O1|Outcome|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
105718|NCT01953081|O2|Outcome|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
105719|NCT01953081|O1|Outcome|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
105720|NCT01953081|E2|Reported Event|Metoclopramide|"Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline~Metoclopramide"
105721|NCT01953081|E1|Reported Event|TD-8954|"TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours~TD-8954"
105722|NCT01952834|B1|Baseline|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
105723|NCT01952834|P1|Participant Flow|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
105724|NCT01952834|O1|Outcome|Probiotic Supplementation|The measurement of IL-2 represents the change in IL-12 +/- standard deviation of the change following 6 weeks of probiotic supplementation.
105725|NCT01952834|O1|Outcome|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
105726|NCT01952834|O1|Outcome|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
105753|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105754|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105727|NCT01952834|O1|Outcome|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
105728|NCT01952834|E1|Reported Event|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
105729|NCT01952691|B1|Baseline|Kinesiotaping|"all patients were implemented a kinesiotaping to align the hallux to correct position~kinesiotaping: correction method was used to align hallux."
105730|NCT01952691|P1|Participant Flow|Kinesiotaping Implementation|"kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment.~kinesiotaping: correction method was used to align hallux's adduction position."
105731|NCT01952691|O1|Outcome|Kinesiotaping Implementation|"kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment.~kinesiotaping: correction method was used to align hallux's adduction position."
105732|NCT01952691|O1|Outcome|Kinesiotaping Implementation|"kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment.~kinesiotaping: correction method was used to align hallux's adduction position."
105733|NCT01952691|O1|Outcome|Kinesiotaping Implementation|"kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment.~kinesiotaping: correction method was used to align hallux's adduction position."
105734|NCT01952691|E1|Reported Event|Kinesiotaping Implementation|"kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment.~kinesiotaping: correction method was used to align hallux's adduction position."
105735|NCT01952665|B3|Baseline|Total|Total of all reporting groups
105736|NCT01952665|B2|Baseline|Lotrafilcon B Then Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105737|NCT01952665|B1|Baseline|Comfilcon A Then Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105738|NCT01952665|P2|Participant Flow|Lotrafilcon B Then Comfilcon A|Each subject randomized to wear either the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105739|NCT01952665|P1|Participant Flow|Comfilcon A Then Lotrafilcon B|Each subject randomized to wear either the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105740|NCT01952665|O3|Outcome|Habitual Lens|Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
105741|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105742|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105743|NCT01952665|O3|Outcome|Habitual Lens|Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
105744|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105745|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105746|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105747|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105748|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105749|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105750|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105751|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
106016|NCT01951703|P2|Participant Flow|Test/Control|Subjects that received Test lens, senofilcon A for the first two weeks and then received Control lens senofilcon A in the last two weeks of the study.
105755|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105756|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105757|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105758|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105759|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105760|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105761|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105762|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105763|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105764|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105765|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105766|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105767|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105768|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105769|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105770|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105771|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105772|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105773|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105774|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105775|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105776|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105777|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105778|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105779|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105780|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105781|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105782|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105783|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105784|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105785|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105786|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105787|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105788|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105789|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105790|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105791|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105792|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105793|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105794|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105795|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105796|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105797|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105798|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105799|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105800|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105801|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105802|NCT01952665|O2|Outcome|Habitual Lenses|Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
105803|NCT01952665|O1|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105804|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105805|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105806|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105807|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105808|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105809|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105810|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105811|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105812|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105813|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105814|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105815|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105816|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105817|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105818|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105819|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105820|NCT01952665|O2|Outcome|Habitual Lenses|Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
105821|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105822|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105823|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105824|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105825|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105826|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105827|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105828|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105829|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105830|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105831|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105832|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105833|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105834|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105835|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105836|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105837|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105838|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105839|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105840|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105841|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105842|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105843|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105844|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105845|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105846|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105847|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105848|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105849|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105850|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105851|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105852|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105853|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105854|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105855|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105856|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105857|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105858|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105859|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105860|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105861|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105862|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105863|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105864|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105865|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105866|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105867|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105868|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105869|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105870|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105871|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105872|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
105873|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
106017|NCT01951703|P1|Participant Flow|Control/Test|Subjects that received Control lens, senofilcon A for the first two weeks and then received Test lens senofilcon A in the last two weeks of the study.
105874|NCT01952665|E2|Reported Event|Lotrafilcon B|"Daily wear soft contact lens lotrafilcon B~comfilcon A: Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period."
105875|NCT01952665|E1|Reported Event|Comfilcon A|"Daily wear soft contact lens comfilcon A~lotrafilcon B: Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period."
105876|NCT01952600|B4|Baseline|Total|Total of all reporting groups
105877|NCT01952600|B3|Baseline|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
105878|NCT01952600|B2|Baseline|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
105879|NCT01952600|B1|Baseline|Chronic Kidney Disease (CKD)|Patients who have advanced chronic kidney disease, but are not currently on either hemodialysis (HD) or peritoneal dialysis (PD).
105880|NCT01952600|P3|Participant Flow|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
105881|NCT01952600|P2|Participant Flow|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
105882|NCT01952600|P1|Participant Flow|Chronic Kidney Disease (CKD)|Patients who have advanced chronic kidney disease, but are not currently on either hemodialysis (HD) or peritoneal dialysis (PD).
105883|NCT01952600|O3|Outcome|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
105884|NCT01952600|O2|Outcome|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
105885|NCT01952600|O1|Outcome|Chronic Kidney Disease (CKD)|Patients who have advanced chronic kidney disease, but are not currently on either hemodialysis (HD) or peritoneal dialysis (PD).
105886|NCT01952600|E3|Reported Event|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
105887|NCT01952600|E2|Reported Event|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
105888|NCT01952600|E1|Reported Event|Chronic Kidney Disease (CKD)|Patients who have advanced chronic kidney disease, but are not currently on either hemodialysis (HD) or peritoneal dialysis (PD).
105889|NCT01952418|B3|Baseline|Total|Total of all reporting groups
105890|NCT01952418|B2|Baseline|"Large Monitor (32)"|"Endoscopists in this arm will perform colonoscopy using the large size video monitor (32)."
105891|NCT01952418|B1|Baseline|"Standard Monitor (24)"|"Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24)."
105892|NCT01952418|P2|Participant Flow|"Large Monitor (32)"|"Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32)."
105893|NCT01952418|P1|Participant Flow|"Standard Monitor (24)"|"Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24)."
105894|NCT01952418|O2|Outcome|"Large Monitor (32)"|"Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32)."
105895|NCT01952418|O1|Outcome|"Standard Monitor (24)"|"Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24)."
105896|NCT01952418|O2|Outcome|"Large Monitor (32)"|"Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32)."
105897|NCT01952418|O1|Outcome|"Standard Monitor (24)"|"Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24)."
105898|NCT01952418|O2|Outcome|"Large Monitor (32)"|"Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32)."
105899|NCT01952418|O1|Outcome|"Standard Monitor (24)"|"Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24)."
105900|NCT01952418|O2|Outcome|"Large Monitor (32)"|"Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32)."
105901|NCT01952418|O1|Outcome|"Standard Monitor (24)"|"Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24)."
105902|NCT01952418|E2|Reported Event|"Large Monitor (32)"|"Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32)."
105903|NCT01952418|E1|Reported Event|"Standard Monitor (24)"|"Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24)."
105904|NCT01952366|B1|Baseline|Depressed Patients|Patients admitted to specialist health care service of old age psychiatry
105905|NCT01952366|P1|Participant Flow|Depressed Patients|Patients admitted to specialist health care service of old age psychiatry
105906|NCT01952366|O1|Outcome|Depressed Patients|Patients admitted to specialist health care service of old age psychiatry
105907|NCT01952366|O2|Outcome|Remission in Depressed Patients|Number of patients admitted to specialist health care service of old age psychiatry who demonstrated a remission (MADRS score of 9 or less) by the end of their hospital stay.
105908|NCT01952366|O1|Outcome|Response in Depressed Patients|Number of patients admitted to specialist health care service of old age psychiatry who demonstrated a response (50% improvement of the MADRS score) during stay in the hospital.
105909|NCT01952366|E1|Reported Event|Depressed Patients|Patients admitted to specialist health care service of old age psychiatry
105910|NCT01952301|B1|Baseline|Xenogeneic Collagen Matrix Versus Free Gingival Graft|free gingival graft versus a xenogeneic collagen matrix over an apically positioned flap used to generate keratinized tissue
105911|NCT01952301|P1|Participant Flow|XCM Versus FGG|xenogeneic collagen matrix versus free gingival graft
105912|NCT01952301|O2|Outcome|Xenogeneic Collagen Matrix|xenogeneic collagen matrix over an apically positioned flap to generate keratinized tissue
105913|NCT01952301|O1|Outcome|Free Gingival Graft|free gingival graft over an apically positioned flap used to generate keratinized tissue
105914|NCT01952301|E2|Reported Event|Xenogeneic Collagen Matrix|xenogeneic collagen matrix over an apically positioned flap used to generate keratinized tissue
105915|NCT01952301|E1|Reported Event|Free Gingival Graft|free gingival graft over an apically positioned flap used to generate keratinized tissue
105916|NCT01952145|B3|Baseline|Total|Total of all reporting groups
107001|NCT01947517|O1|Outcome|Parasol Group|"Randomized to receive Brand A punctal plugs~Parasol Punctal Occluder"
105917|NCT01952145|B2|Baseline|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
105918|NCT01952145|B1|Baseline|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
105919|NCT01952145|P2|Participant Flow|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
105920|NCT01952145|P1|Participant Flow|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
105921|NCT01952145|O2|Outcome|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
105922|NCT01952145|O1|Outcome|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
105923|NCT01952145|O2|Outcome|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
105924|NCT01952145|O1|Outcome|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
105925|NCT01952145|O2|Outcome|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
105926|NCT01952145|O1|Outcome|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
105927|NCT01952145|E2|Reported Event|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
105928|NCT01952145|E1|Reported Event|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
105929|NCT01952080|B5|Baseline|Total|Total of all reporting groups
105930|NCT01952080|B4|Baseline|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
105931|NCT01952080|B3|Baseline|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
105932|NCT01952080|B2|Baseline|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
105933|NCT01952080|B1|Baseline|Standard of Care|SOC- no teduglutide therapy
105934|NCT01952080|P4|Participant Flow|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
105935|NCT01952080|P3|Participant Flow|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
105936|NCT01952080|P2|Participant Flow|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
105937|NCT01952080|P1|Participant Flow|Standard of Care|SOC- no teduglutide therapy
105938|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
105939|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
105940|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
105941|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
105942|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
105943|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
105944|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
105945|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
105946|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
105947|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
105948|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
105949|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
105950|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
105951|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
105952|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
105953|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
105954|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
105955|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
105956|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
105957|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
105958|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
105959|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
105960|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
105961|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
105962|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
105963|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
105964|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
105965|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
105966|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
105967|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
105968|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
105969|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
105970|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
105971|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
105972|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
105973|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
105974|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
105975|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
105976|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
105977|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
105978|NCT01952080|E4|Reported Event|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
105979|NCT01952080|E3|Reported Event|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
105980|NCT01952080|E2|Reported Event|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
105981|NCT01952080|E1|Reported Event|Standard of Care|SOC- no teduglutide therapy
105982|NCT01951963|B3|Baseline|Total|Total of all reporting groups
105983|NCT01951963|B2|Baseline|Morphine|"Morphine, single dose, 0.05 mg/kg, IV~The final sample included 40 subjects, 20 in the Morphine group. The baseline characteristics were similar between the two groups. These patients were randomized to receive a single bolus of morphine (0.05mg/kg). These are standard recommended pediatric weight-based analgesic doses of Morphine. Patient weight was obtained by the treating RN using a scale or Broselow tape. A blinded 10mL syringe containing study drug was prepared and delivered to the bedside by a pharmacist. After administration of study drug all future analgesic doses were restricted to morphine and were given at the discretion of the treatment team."
105984|NCT01951963|B1|Baseline|Ketamine|"Ketamine, single dose, 0.3 mg/kg, IV~The final sample included 40 subjects, 20 in the Ketamine group. Inclusion criteria was defined as, patients age 3-17 years old, medical or traumatic condition requiring intravenous opioid analgesics, ability to obtain consent from parents and assent from the patient. The baseline characteristics were similar between the two groups. These patients were randomized to receive a single bolus of ketamine (0.3 mg/kg). These are standard recommended pediatric weight-based analgesic doses of Ketamine. Patient weight was obtained by the treating RN using a scale or Broselow tape. A blinded 10mL syringe containing study drug was prepared and delivered to the bedside by a pharmacist. After administration of study drug all future analgesic doses were restricted to morphine and were given at the discretion of the treatment team."
105985|NCT01951963|P2|Participant Flow|Morphine|"Morphine, single dose, 0.05 mg/kg, IV~The final sample included 40 subjects, 20 in the Morphine group. The baseline characteristics were similar between the two groups. These patients were randomized to receive a single bolus of morphine (0.05mg/kg). These are standard recommended pediatric weight-based analgesic doses of Morphine. Patient weight was obtained by the treating RN using a scale or Broselow tape. A blinded 10mL syringe containing study drug was prepared and delivered to the bedside by a pharmacist. After administration of study drug all future analgesic doses were restricted to morphine and were given at the discretion of the treatment team."
105986|NCT01951963|P1|Participant Flow|Ketamine|"Ketamine, single dose, 0.3 mg/kg, IV~The final sample included 40 subjects, 20 in the Ketamine group. The baseline characteristics were similar between the two groups. These patients were randomized to receive a single bolus of ketamine (0.3 mg/kg). These are standard recommended pediatric weight-based analgesic doses of Ketamine. Patient weight was obtained by the treating RN using a scale or Broselow tape. A blinded 10mL syringe containing study drug was prepared and delivered to the bedside by a pharmacist. After administration of study drug all future analgesic doses were restricted to morphine and were given at the discretion of the treatment team."
105987|NCT01951963|O2|Outcome|Morphine|"Morphine, single dose, 0.05 mg/kg, IV~The final sample included 40 subjects, 20 in the Morphine group. The baseline characteristics were similar between the two groups. These patients were randomized to receive a single bolus of morphine (0.05mg/kg). These are standard recommended pediatric weight-based analgesic doses of Morphine. Patient weight was obtained by the treating RN using a scale or Broselow tape. A blinded 10mL syringe containing study drug was prepared and delivered to the bedside by a pharmacist. After administration of study drug all future analgesic doses were restricted to morphine and were given at the discretion of the treatment team."
105988|NCT01951963|O1|Outcome|Ketamine|"Ketamine, single dose, 0.3 mg/kg, IV~The final sample included 40 subjects, 20 in the Ketamine group. The baseline characteristics were similar between the two groups. These patients were randomized to receive a single bolus of ketamine (0.3 mg/kg). These are standard recommended pediatric weight-based analgesic doses of Ketamine. Patient weight was obtained by the treating RN using a scale or Broselow tape. A blinded 10mL syringe containing study drug was prepared and delivered to the bedside by a pharmacist. After administration of study drug all future analgesic doses were restricted to morphine and were given at the discretion of the treatment team."
105989|NCT01951963|O2|Outcome|Morphine|"Morphine, single dose, 0.05 mg/kg, IV~Morphine"
105990|NCT01951963|O1|Outcome|Ketamine|"Ketamine, single dose, 0.3 mg/kg, IV~Ketamine"
105991|NCT01951963|O2|Outcome|Morphine|"Morphine, single dose, 0.05 mg/kg, IV~Morphine~prospective, double blind, randomized control trial. After informed consent, patients 3-17 years old requiring intravenous analgesics were randomized to receive either a single dose of 0.3mg/kg ketamine or 0.05mg/kg morphine in addition to standard opioid based analgesia. These weight-based doses of Ketamine and Morphine are the standard recommended doses from the Lexicomp Drug Reference Handbook, Pediatric and Neonatal Dosing (2011-2012)."
105992|NCT01951963|O1|Outcome|Ketamine|"Ketamine, single dose, 0.3 mg/kg, IV~Ketamine~prospective, double blind, randomized control trial. After informed consent, patients 3-17 years old requiring intravenous analgesics were randomized to receive either a single dose of 0.3mg/kg ketamine or 0.05mg/kg morphine in addition to standard opioid based analgesia. These weight-based doses of Ketamine and Morphine are the standard recommended doses from the Lexicomp Drug Reference Handbook, Pediatric and Neonatal Dosing (2011-2012)."
105993|NCT01951963|E2|Reported Event|Morphine|"Morphine, single dose, 0.05 mg/kg, IV~Morphine"
105994|NCT01951963|E1|Reported Event|Ketamine|"Ketamine, single dose, 0.3 mg/kg, IV~Ketamine"
105995|NCT01951950|B3|Baseline|Total|Total of all reporting groups
105996|NCT01951950|B2|Baseline|Esmolol|Subjects will receive a 0.5 mg/kg bolus of esmolol as needed followed by an infusion initiated at 50 mcg/kg/min. Esmolol may be titrated every 5 minutes, increasing 50 mcg/kg/min and administering 0.5 mg/kg bolus every minute to a maximum dose of 200 mcg/kg/min. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of esmolol, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
105997|NCT01951950|B1|Baseline|Nicardipine|Subjects will receive a 15 mcg/kg bolus of nicardipine as needed followed by an infusion initiated at 5 mg/hr. Nicardipine may be titrated every 5 minutes, increasing 5 mg/hr and administering 15 mcg/kg bolus every minute to a maximum dose of 15 mg/hr. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of nicardipine, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
106018|NCT01951703|O2|Outcome|Test, Senofilcon A|Subjects who received Test lens, senofilcon A in either the first two weeks or the last two weeks of the study.
106019|NCT01951703|O1|Outcome|Control, Senofilcon A|Subjects who received Control lens, senofilcon A in either the first two weeks or the last two weeks of the study.
106020|NCT01951703|O2|Outcome|Test, Senofilcon A|Subject who received Test lens, senofilcon A in either the first two weeks or the last two weeks of the study.
105998|NCT01951950|P2|Participant Flow|Esmolol|Subjects will receive a 0.5 mg/kg bolus of esmolol as needed followed by an infusion initiated at 50 mcg/kg/min. Esmolol may be titrated every 5 minutes, increasing 50 mcg/kg/min and administering 0.5 mg/kg bolus every minute to a maximum dose of 200 mcg/kg/min. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of esmolol, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
105999|NCT01951950|P1|Participant Flow|Nicardipine|Subjects will receive a 15 mcg/kg bolus of nicardipine as needed followed by an infusion initiated at 5 mg/hr. Nicardipine may be titrated every 5 minutes, increasing 5 mg/hr and administering 15 mcg/kg bolus every minute to a maximum dose of 15 mg/hr. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of nicardipine, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
106000|NCT01951950|O2|Outcome|Esmolol|Subjects will receive a 0.5 mg/kg bolus of esmolol as needed followed by an infusion initiated at 50 mcg/kg/min. Esmolol may be titrated every 5 minutes, increasing 50 mcg/kg/min and administering 0.5 mg/kg bolus every minute to a maximum dose of 200 mcg/kg/min. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of esmolol, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
106001|NCT01951950|O1|Outcome|Nicardipine|Subjects will receive a 15 mcg/kg bolus of nicardipine as needed followed by an infusion initiated at 5 mg/hr. Nicardipine may be titrated every 5 minutes, increasing 5 mg/hr and administering 15 mcg/kg bolus every minute to a maximum dose of 15 mg/hr. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of nicardipine, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
106002|NCT01951950|E2|Reported Event|Esmolol|Subjects will receive a 0.5 mg/kg bolus of esmolol as needed followed by an infusion initiated at 50 mcg/kg/min. Esmolol may be titrated every 5 minutes, increasing 50 mcg/kg/min and administering 0.5 mg/kg bolus every minute to a maximum dose of 200 mcg/kg/min. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of esmolol, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
106003|NCT01951950|E1|Reported Event|Nicardipine|Subjects will receive a 15 mcg/kg bolus of nicardipine as needed followed by an infusion initiated at 5 mg/hr. Nicardipine may be titrated every 5 minutes, increasing 5 mg/hr and administering 15 mcg/kg bolus every minute to a maximum dose of 15 mg/hr. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of nicardipine, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
106004|NCT01951820|B3|Baseline|Total|Total of all reporting groups
106005|NCT01951820|B2|Baseline|Pliaglis|"Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Pliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
106006|NCT01951820|B1|Baseline|Benzocaine|"benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Benzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
106007|NCT01951820|P2|Participant Flow|Pliaglis|"Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Pliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
106008|NCT01951820|P1|Participant Flow|Benzocaine|"benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Benzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
106009|NCT01951820|O2|Outcome|Pliaglis|"Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Pliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
106010|NCT01951820|O1|Outcome|Benzocaine|"Benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Benzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
106011|NCT01951820|E2|Reported Event|Pliaglis|"Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Pliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
106012|NCT01951820|E1|Reported Event|Benzocaine|"benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Benzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
106013|NCT01951703|B3|Baseline|Total|Total of all reporting groups
106014|NCT01951703|B2|Baseline|Test/Control|Subjects who received Test lens, senofilcon A for the first two weeks of the study and then received Control lens, senofilcon A in the last two weeks of the study.
106015|NCT01951703|B1|Baseline|Control/Test|Subjects who received Control lens, senofilcon A for the first two weeks of the study and then received Test lens, senofilcon A in the last two weeks of the study.
106021|NCT01951703|O1|Outcome|Control, Senofilcon A|Subjects who received Control lens, senofilcon A in either the first two weeks or the last two weeks of the study.
106022|NCT01951703|E2|Reported Event|Test, Senofilcon A|Subjects who received Test lens senofilcon A in either the first two weeks or the last two weeks of the study,
106023|NCT01951703|E1|Reported Event|Control, Senofilcon A|Subjects who received Control lens, senofilcon A in either the first two weeks or the last two weeks of the study.
106024|NCT01951651|B3|Baseline|Total|Total of all reporting groups
106025|NCT01951651|B2|Baseline|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months~Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
106026|NCT01951651|B1|Baseline|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months~Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
106027|NCT01951651|P2|Participant Flow|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months~Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
106028|NCT01951651|P1|Participant Flow|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months~Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
106029|NCT01951651|O2|Outcome|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months~Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
106030|NCT01951651|O1|Outcome|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months~Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
106031|NCT01951651|O2|Outcome|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months~Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
106042|NCT01951586|P2|Participant Flow|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
107002|NCT01947517|O2|Outcome|Superflex Group|"Randomized to receive Group B punctal plugs~Superflex Punctal Occluder"
106032|NCT01951651|O1|Outcome|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months~Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
106033|NCT01951651|O2|Outcome|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months~Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
106034|NCT01951651|O1|Outcome|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months~Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
106035|NCT01951651|O2|Outcome|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months~Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
106036|NCT01951651|O1|Outcome|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months~Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
106037|NCT01951651|E2|Reported Event|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months~Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
106038|NCT01951651|E1|Reported Event|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months~Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
106039|NCT01951586|B3|Baseline|Total|Total of all reporting groups
106040|NCT01951586|B2|Baseline|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
106041|NCT01951586|B1|Baseline|Placebo|Participants received placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
106113|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
106043|NCT01951586|P1|Participant Flow|Placebo|Participants received placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
106044|NCT01951586|O2|Outcome|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
106045|NCT01951586|O1|Outcome|Placebo|Participants received placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
106046|NCT01951586|O1|Outcome|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
106047|NCT01951586|O1|Outcome|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
106048|NCT01951586|O2|Outcome|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
106049|NCT01951586|O1|Outcome|Placebo|Participants received placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
106050|NCT01951586|O2|Outcome|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
106051|NCT01951586|O1|Outcome|Placebo|Participants received placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
106052|NCT01951586|O2|Outcome|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
106053|NCT01951586|O1|Outcome|Placebo|Participants received placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
106054|NCT01951586|O2|Outcome|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
106055|NCT01951586|O1|Outcome|Placebo|Participants received placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
106056|NCT01951586|O2|Outcome|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
106057|NCT01951586|O1|Outcome|Placebo|Participants received placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
106058|NCT01951586|O2|Outcome|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
106059|NCT01951586|O1|Outcome|Placebo|Participants received placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
108102|NCT01941498|O3|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
106060|NCT01951586|O2|Outcome|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
106061|NCT01951586|O1|Outcome|Placebo|Participants received placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
106062|NCT01951586|O2|Outcome|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
106063|NCT01951586|O1|Outcome|Placebo|Participants received placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
106064|NCT01951586|E2|Reported Event|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
106065|NCT01951586|E1|Reported Event|Placebo|Participants received placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
106066|NCT01951573|B1|Baseline|Overall|Delefilcon A MF and AOAMF contact lenses worn during Period 1 and Period 2 in a crossover assignment.
106067|NCT01951573|P2|Participant Flow|AOAMF, Then Delefilcon A MF|Each product worn bilaterally (ie, in both eyes), as randomized, for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.
106068|NCT01951573|P1|Participant Flow|Delefilcon A MF, Then AOAMF|Each product worn bilaterally (ie, in both eyes), as randomized, for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.
106069|NCT01951573|O2|Outcome|AOAMF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
106070|NCT01951573|O1|Outcome|Delefilcon A MF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
106071|NCT01951573|O2|Outcome|AOAMF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
106072|NCT01951573|O1|Outcome|Delefilcon A MF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
106073|NCT01951573|O2|Outcome|AOAMF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
106074|NCT01951573|O1|Outcome|Delefilcon A MF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
106075|NCT01951573|E2|Reported Event|AOAMF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
106076|NCT01951573|E1|Reported Event|Delefilcon A MF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
106077|NCT01951417|B1|Baseline|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
106078|NCT01951417|P1|Participant Flow|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
106079|NCT01951417|O4|Outcome|Week 8|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
106080|NCT01951417|O3|Outcome|Week 4|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
106081|NCT01951417|O2|Outcome|Week 2|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
106082|NCT01951417|O1|Outcome|Baseline|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
106083|NCT01951417|O4|Outcome|Week 8|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
106084|NCT01951417|O3|Outcome|Week 4|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
106085|NCT01951417|O2|Outcome|Week 2|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
106086|NCT01951417|O1|Outcome|Baseline|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
106087|NCT01951417|O4|Outcome|Week 8|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
106088|NCT01951417|O3|Outcome|Week 4|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
106089|NCT01951417|O2|Outcome|Week 2|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
106090|NCT01951417|O1|Outcome|Baseline|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
106091|NCT01951417|O4|Outcome|Week 8|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
106092|NCT01951417|O3|Outcome|Week 4|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
106093|NCT01951417|O2|Outcome|Week 2|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
106094|NCT01951417|O1|Outcome|Baseline|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
106095|NCT01951417|O1|Outcome|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
106096|NCT01951417|O1|Outcome|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
106097|NCT01951417|O1|Outcome|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
106098|NCT01951417|O1|Outcome|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
106099|NCT01951417|E1|Reported Event|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
106100|NCT01951170|B1|Baseline|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
106101|NCT01951170|P1|Participant Flow|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 milligrams (mg) was administered subcutaneously once weekly for 24 weeks"
106102|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
106103|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
106104|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
106105|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
106106|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
106107|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
106108|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
106109|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
106110|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
106111|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
106112|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
106114|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
106115|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
106116|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
106117|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
106118|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
106119|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
106120|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
106121|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
106122|NCT01951170|E1|Reported Event|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: Tocilizumab was administered 162 mg subcutaneously once weekly for 24 weeks"
106123|NCT01951092|B1|Baseline|Single Arm Intervention Study|All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.
106124|NCT01951092|P1|Participant Flow|Single Arm Intervention Study|"All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.~Text messaging"
106125|NCT01951092|O1|Outcome|Single Arm Intervention Study|All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.
106126|NCT01951092|O1|Outcome|Single Arm Intervention Study|All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.
106127|NCT01951092|E1|Reported Event|Single Arm Intervention Study|All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.
106128|NCT01951066|B1|Baseline|All Participants|
106129|NCT01951066|P2|Participant Flow|Group 2 (Anti-VEGF/Dexamethasone Implant)|"Patients in group 2 received prn anti-VEGF injections followed by injection of a dexamethasone implant after crossover at week 16.~Dexamethasone Implant: Patients will receive a single injection of a dexmethasone implant~Anti-VEGF injection: Patients will receive PRN injections of an anti-VEGF agent"
106130|NCT01951066|P1|Participant Flow|Group 1 (Dexamethasone Implant/Anti-VEGF)|"Patients in group 1 received an injection of an dexamethasone implant at baseline followed by PRN anti-VEGF injections after crossover at week 16.~Dexamethasone Implant: Patients will receive a single injection of a dexmethasone implant~Anti-VEGF injection: Patients will receive PRN injections of an anti-VEGF agent"
106131|NCT01951066|O2|Outcome|Anti-VEGF Agent|Patients received PRN injections of an Anti-VEGF agent
106132|NCT01951066|O1|Outcome|Dexamethasone Implant|Patients received an injection of an dexamethasone implant
106133|NCT01951066|E1|Reported Event|All Participants|
106134|NCT01950741|B1|Baseline|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
106135|NCT01950741|P1|Participant Flow|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
106136|NCT01950741|O1|Outcome|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
106137|NCT01950741|O1|Outcome|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
107003|NCT01947517|O1|Outcome|Parasol Group|"Randomized to receive Brand A punctal plugs~Parasol Punctal Occluder"
106138|NCT01950741|O1|Outcome|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
106139|NCT01950741|O1|Outcome|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
106140|NCT01950741|O1|Outcome|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
106141|NCT01950741|O1|Outcome|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
106142|NCT01950741|E1|Reported Event|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe.~Among 48 patients enrolled, one patient withdrew the consent before undergoing the first injection. Therefore the adverse event was assessed in 47 patients."
106143|NCT01950663|B1|Baseline|RETeval|"RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light.~RETeval: RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light."
106144|NCT01950663|P1|Participant Flow|RETeval|"RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light.~RETeval: RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light."
106145|NCT01950663|O1|Outcome|RETeval|"RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light.~RETeval: RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light."
106146|NCT01950663|E1|Reported Event|RETeval|"RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light.~RETeval: RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light."
106147|NCT01950364|B3|Baseline|Total|Total of all reporting groups
106148|NCT01950364|B2|Baseline|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106149|NCT01950364|B1|Baseline|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106150|NCT01950364|P2|Participant Flow|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 milligram (mg), capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106151|NCT01950364|P1|Participant Flow|Brentuximab Vedotin|Brentuximab vedotin 1.8 milligram per kilogram (mg/kg), injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106152|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106153|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106154|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106155|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106156|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106157|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106158|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106159|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106160|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106161|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106162|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106163|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106164|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106165|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106166|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106167|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106168|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106169|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106170|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106171|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106172|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106173|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106174|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106175|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106176|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106177|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106178|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106179|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106180|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106181|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106182|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106183|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106184|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106185|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106186|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106187|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
108103|NCT01941498|O2|Outcome|Day 1 Postoperative|WaveLight Refractive Suite
106188|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106189|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106190|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106191|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106192|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106193|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106194|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106195|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106196|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106197|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106198|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106199|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106200|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106201|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106202|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106203|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106204|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106205|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106206|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106207|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106208|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106209|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106210|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106211|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106212|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106213|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
108104|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
106214|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106215|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106216|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106217|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106218|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106219|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106220|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106221|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106222|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106223|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106224|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106225|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106226|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106227|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106228|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106229|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106230|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106231|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106232|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106233|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106234|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106235|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106236|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106237|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106238|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106239|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
108105|NCT01941498|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
106240|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106241|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106242|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106243|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106244|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106245|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106246|NCT01950364|E2|Reported Event|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
106247|NCT01950364|E1|Reported Event|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
106248|NCT01950078|B3|Baseline|Total|Total of all reporting groups
106249|NCT01950078|B2|Baseline|Healthy Volunteers Group|grouped by healthy college students
106250|NCT01950078|B1|Baseline|Surgical Patients|grouped by receiving surgery
106251|NCT01950078|P2|Participant Flow|Healthy Volunteers Group|grouped by healthy college students
106252|NCT01950078|P1|Participant Flow|Surgical Patients|grouped by receiving surgery
106253|NCT01950078|O2|Outcome|Healthy Volunteers Group|grouped by healthy college students
106254|NCT01950078|O1|Outcome|Surgical Patients|grouped by receiving surgery
106255|NCT01950078|O2|Outcome|Healthy Volunteers Group|grouped by healthy college students
106256|NCT01950078|O1|Outcome|Surgical Patients|grouped by receiving surgery
106257|NCT01950078|E2|Reported Event|Healthy Volunteers Group|grouped by healthy college students
106258|NCT01950078|E1|Reported Event|Surgical Patients|grouped by receiving surgery
106259|NCT01949870|B1|Baseline|Selumetinib+ Cisplatin + Gemcitabine|"Selumetinib (25 mg bd)~For each 21-day cycle:~Cisplatin (25 mg/m2) Days 1 and 8 Gemcitabine (1000 mg/m2) Days 1 and 8"
106260|NCT01949870|P1|Participant Flow|Selumetinib+ Cisplatin + Gemcitabine|"Selumetinib (25 mg bd)~For each 21-day cycle:~Cisplatin (25 mg/m2) Days 1 and 8 Gemcitabine (1000 mg/m2) Days 1 and 8"
106261|NCT01949870|O1|Outcome|Selumetinib+ Cisplatin + Gemcitabine|"Selumetinib (25 mg bd)~For each 21-day cycle:~Cisplatin (25 mg/m2) Days 1 and 8 Gemcitabine (1000 mg/m2) Days 1 and 8"
106262|NCT01949870|E1|Reported Event|Selumetinib+ Cisplatin + Gemcitabine|"Selumetinib (25 mg bd)~For each 21-day cycle:~Cisplatin (25 mg/m2) Days 1 and 8 Gemcitabine (1000 mg/m2) Days 1 and 8"
106263|NCT01949545|B5|Baseline|Total|Total of all reporting groups
106264|NCT01949545|B4|Baseline|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106265|NCT01949545|B3|Baseline|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106266|NCT01949545|B2|Baseline|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106267|NCT01949545|B1|Baseline|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106268|NCT01949545|P4|Participant Flow|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
107004|NCT01947517|O2|Outcome|Superflex Group|"Randomized to receive Group B punctal plugs~Superflex Punctal Occluder"
106269|NCT01949545|P3|Participant Flow|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106270|NCT01949545|P2|Participant Flow|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106271|NCT01949545|P1|Participant Flow|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106272|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106273|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106274|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106275|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106276|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106277|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106278|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106279|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106280|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106772|NCT01948908|B2|Baseline|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
106281|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106282|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106283|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106284|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106285|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106286|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106287|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106288|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106289|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106290|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106291|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106292|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106773|NCT01948908|B1|Baseline|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
106293|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106294|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106295|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106296|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106297|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106298|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106299|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106300|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106301|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106302|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106303|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106304|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106774|NCT01948908|P3|Participant Flow|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
106305|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106306|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106307|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106308|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106309|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106310|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106311|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106312|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106313|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106314|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106315|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106316|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106775|NCT01948908|P2|Participant Flow|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
106317|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106318|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106319|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106320|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106321|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106322|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106323|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106324|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106325|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106326|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106327|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106328|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106776|NCT01948908|P1|Participant Flow|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
106329|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106330|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106331|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106332|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106333|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106334|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106335|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106336|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106337|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106338|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106339|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106340|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106777|NCT01948908|O3|Outcome|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
106341|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106342|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106343|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106344|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106345|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106346|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106347|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106348|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106349|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106350|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106351|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106352|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106778|NCT01948908|O2|Outcome|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
106353|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106354|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106355|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106356|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106357|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106358|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106359|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106360|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106361|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106362|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106363|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106364|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106779|NCT01948908|O1|Outcome|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
106365|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106366|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106367|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106368|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106369|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106370|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106371|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106372|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106373|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106374|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106375|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106376|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106780|NCT01948908|O3|Outcome|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
106377|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106378|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106379|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106380|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106381|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106382|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106383|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106384|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106385|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106386|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106387|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106388|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106781|NCT01948908|O2|Outcome|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
106389|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106390|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106391|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106392|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106393|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106394|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106395|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106396|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106397|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106398|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106399|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106400|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106782|NCT01948908|O1|Outcome|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
106401|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106402|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106403|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106404|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106405|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106406|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106407|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106408|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106409|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106410|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106411|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106412|NCT01949545|E4|Reported Event|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106783|NCT01948908|O3|Outcome|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
106413|NCT01949545|E3|Reported Event|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106414|NCT01949545|E2|Reported Event|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106415|NCT01949545|E1|Reported Event|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
106416|NCT01949532|B3|Baseline|Total|Total of all reporting groups
106417|NCT01949532|B2|Baseline|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106418|NCT01949532|B1|Baseline|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106419|NCT01949532|P2|Participant Flow|End Stage Renal Disease|Participants with end-stage renal disease (on hemodialysis) received carfilzomib 20 mg/m² intravenous infusion (IV) on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles. Participants continued treatment until confirmed progressive disease, unacceptable toxicity, withdrawal of consent, study closure, or death.
106420|NCT01949532|P1|Participant Flow|Normal Renal Function|Participants with normal renal function (creatinine clearance [CrCl] ≥ 75 mL/min) received carfilzomib 20 mg/m² intravenous infusion (IV) on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles. Participants continued treatment until confirmed progressive disease, unacceptable toxicity, withdrawal of consent, study closure, or death.
106421|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106422|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106423|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106424|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106425|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106426|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106427|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106428|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106429|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106576|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106430|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106431|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106432|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106433|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106434|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106435|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106436|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106437|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106438|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106439|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106440|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106441|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106442|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106443|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106444|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106445|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106446|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106447|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106448|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106449|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106450|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106451|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106452|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106453|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106454|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106455|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106456|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106457|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106458|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106459|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106460|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106461|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106462|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106463|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106464|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106465|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106466|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106467|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106468|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106469|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106470|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106471|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106472|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106473|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106474|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106475|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106476|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106477|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106478|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106479|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106480|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106481|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106482|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106483|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106484|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106485|NCT01949532|E2|Reported Event|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106486|NCT01949532|E1|Reported Event|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
106487|NCT01949389|B1|Baseline|Internet-based Cognitive Behavioral Therapy for Insomnia|"This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.~Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered."
106488|NCT01949389|P1|Participant Flow|Internet-based Cognitive Behavioral Therapy for Insomnia|"This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.~Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered."
106489|NCT01949389|O1|Outcome|Internet-based Cognitive Behavioral Therapy for Insomnia|"This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.~Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered."
106490|NCT01949389|O1|Outcome|Internet-based Cognitive Behavioral Therapy for Insomnia|"This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.~Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered."
106491|NCT01949389|E1|Reported Event|Internet-based Cognitive Behavioral Therapy for Insomnia|"This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.~Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered."
106492|NCT01949155|B3|Baseline|Total|Total of all reporting groups
106493|NCT01949155|B2|Baseline|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
106494|NCT01949155|B1|Baseline|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
106495|NCT01949155|P2|Participant Flow|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
106496|NCT01949155|P1|Participant Flow|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
106497|NCT01949155|O2|Outcome|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery"
106498|NCT01949155|O1|Outcome|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
106499|NCT01949155|O2|Outcome|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery"
106500|NCT01949155|O1|Outcome|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
106501|NCT01949155|O2|Outcome|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
106502|NCT01949155|O1|Outcome|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
106503|NCT01949155|E2|Reported Event|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
106504|NCT01949155|E1|Reported Event|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
106505|NCT01949142|B3|Baseline|Total|Total of all reporting groups
106506|NCT01949142|B2|Baseline|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
106507|NCT01949142|B1|Baseline|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
106508|NCT01949142|P2|Participant Flow|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
106509|NCT01949142|P1|Participant Flow|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
106510|NCT01949142|O2|Outcome|Sham|Sham: Simulated single, intratympanic injection: One sham injection into each ear during surgery.
106511|NCT01949142|O1|Outcome|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
106512|NCT01949142|O2|Outcome|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
106513|NCT01949142|O1|Outcome|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
106514|NCT01949142|O2|Outcome|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
106515|NCT01949142|O1|Outcome|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
106516|NCT01949142|E2|Reported Event|Sham-Simulated Single, Intratympanic Injection|Sham: One sham injection into each ear during surgery.
106517|NCT01949142|E1|Reported Event|OTO-201 Single, Intratympanic Injection|OTO-201: One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery.
106518|NCT01949116|B3|Baseline|Total|Total of all reporting groups
106519|NCT01949116|B2|Baseline|Placebo|"From study entry through Week 1, participants will receive 5 mg of placebo once a week. For participants who are clinically stable at the Week 1 study visit, the dose will be increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose will be increased to 15 mg once a week through Week 24. In addition to placebo, all participants will also receive 1 mg of folic acid once a day from study entry through 4 weeks after placebo is discontinued, either at Week 24 or earlier, for any reason.~Placebo: Placebo 5 mg: one 5-mg capsule by mouth once weekly~Placebo 10 mg: two 5-mg capsules by mouth once weekly~Placebo 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106577|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106784|NCT01948908|O2|Outcome|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
106520|NCT01949116|B1|Baseline|Low-dose Methotrexate (LDMTX)|"From study entry through Week 1, participants will receive 5 mg of LDMTX once a week. For participants who are clinically stable at the Week 1 study visit, the dose will be increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose will be increased to 15 mg once a week through Week 24. In addition to LDMTX, all participants will also receive 1 mg of folic acid once a day from study entry through 4 weeks after LDMTX is discontinued, either at Week 24 or earlier, for any reason.~LDMTX: LDMTX 5 mg: one 5-mg capsule by mouth once weekly~LDMTX 10 mg: two 5-mg capsules by mouth once weekly~LDMTX 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106521|NCT01949116|P2|Participant Flow|Placebo|"From study entry through Week 1, participants received 5 mg of placebo once a week. For participants who were clinically stable at the Week 1 study visit, the dose of placebo was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of placebo was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation were re-evaluated at the following study visit. In addition to placebo, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of placebo, all participants continued taking folic acid for an additional 4 weeks.~Placebo: Placebo 5 mg: one 5-mg capsule by mouth once weekly~Placebo 10 mg: two 5-mg capsules by mouth once weekly~Placebo 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106522|NCT01949116|P1|Participant Flow|Low-dose Methotrexate (LDMTX)|"From study entry through Week 1, participants received 5 mg of LDMTX once a week. For participants who were clinically stable at the Week 1 study visit, the dose of LDMTX was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of LDMTX was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation were re-evaluated at the following study visit. In addition to LDMTX, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of LDMTX, all participants continued taking folic acid for an additional 4 weeks.~LDMTX: LDMTX 5 mg: one 5-mg capsule by mouth once weekly~LDMTX 10 mg: two 5-mg capsules by mouth once weekly~LDMTX 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106523|NCT01949116|O2|Outcome|Placebo|"From study entry through Week 1, participants received 5 mg of placebo once a week. For participants who were clinically stable at the Week 1 study visit, the dose of placebo was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of placebo was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to placebo, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of placebo, all participants continued taking folic acid for an additional 4 weeks.~Placebo: Placebo 5 mg: one 5-mg capsule by mouth once weekly~Placebo 10 mg: two 5-mg capsules by mouth once weekly~Placebo 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106524|NCT01949116|O1|Outcome|Low-dose Methotrexate (LDMTX)|"From study entry through Week 1, participants received 5 mg of LDMTX once a week. For participants who were clinically stable at the Week 1 study visit, the dose of LDMTX was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of LDMTX was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to LDMTX, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of LDMTX, all participants continued taking folic acid for an additional 4 weeks.~LDMTX: LDMTX 5 mg: one 5-mg capsule by mouth once weekly~LDMTX 10 mg: two 5-mg capsules by mouth once weekly~LDMTX 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106525|NCT01949116|O2|Outcome|Placebo|"From study entry through Week 1, participants received 5 mg of placebo once a week. For participants who were clinically stable at the Week 1 study visit, the dose of placebo was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of placebo was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to placebo, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of placebo, all participants continued taking folic acid for an additional 4 weeks.~Placebo: Placebo 5 mg: one 5-mg capsule by mouth once weekly~Placebo 10 mg: two 5-mg capsules by mouth once weekly~Placebo 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106526|NCT01949116|O1|Outcome|Low-dose Methotrexate (LDMTX)|"From study entry through Week 1, participants received 5 mg of LDMTX once a week. For participants who were clinically stable at the Week 1 study visit, the dose of LDMTX was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of LDMTX was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to LDMTX, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of LDMTX, all participants continued taking folic acid for an additional 4 weeks.~LDMTX: LDMTX 5 mg: one 5-mg capsule by mouth once weekly~LDMTX 10 mg: two 5-mg capsules by mouth once weekly~LDMTX 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106527|NCT01949116|O2|Outcome|Placebo|"From study entry through Week 1, participants received 5 mg of placebo once a week. For participants who were clinically stable at the Week 1 study visit, the dose of placebo was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of placebo was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to placebo, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of placebo, all participants continued taking folic acid for an additional 4 weeks.~Placebo: Placebo 5 mg: one 5-mg capsule by mouth once weekly~Placebo 10 mg: two 5-mg capsules by mouth once weekly~Placebo 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106770|NCT01948908|B4|Baseline|Total|Total of all reporting groups
106528|NCT01949116|O1|Outcome|Low-dose Methotrexate (LDMTX)|"From study entry through Week 1, participants received 5 mg of LDMTX once a week. For participants who were clinically stable at the Week 1 study visit, the dose of LDMTX was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of LDMTX was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to LDMTX, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of LDMTX, all participants continued taking folic acid for an additional 4 weeks.~LDMTX: LDMTX 5 mg: one 5-mg capsule by mouth once weekly~LDMTX 10 mg: two 5-mg capsules by mouth once weekly~LDMTX 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106529|NCT01949116|O2|Outcome|Placebo|"From study entry through Week 1, participants received 5 mg of placebo once a week. For participants who were clinically stable at the Week 1 study visit, the dose of placebo was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of placebo was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to placebo, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of placebo, all participants continued taking folic acid for an additional 4 weeks.~Placebo: Placebo 5 mg: one 5-mg capsule by mouth once weekly~Placebo 10 mg: two 5-mg capsules by mouth once weekly~Placebo 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106530|NCT01949116|O1|Outcome|Low-dose Methotrexate (LDMTX)|"From study entry through Week 1, participants received 5 mg of LDMTX once a week. For participants who were clinically stable at the Week 1 study visit, the dose of LDMTX was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of LDMTX was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to LDMTX, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of LDMTX, all participants continued taking folic acid for an additional 4 weeks.~LDMTX: LDMTX 5 mg: one 5-mg capsule by mouth once weekly~LDMTX 10 mg: two 5-mg capsules by mouth once weekly~LDMTX 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106531|NCT01949116|O2|Outcome|Placebo|"From study entry through Week 1, participants received 5 mg of placebo once a week. For participants who were clinically stable at the Week 1 study visit, the dose of placebo was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of placebo was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to placebo, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of placebo, all participants continued taking folic acid for an additional 4 weeks.~Placebo: Placebo 5 mg: one 5-mg capsule by mouth once weekly~Placebo 10 mg: two 5-mg capsules by mouth once weekly~Placebo 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106532|NCT01949116|O1|Outcome|Low-dose Methotrexate (LDMTX)|"From study entry through Week 1, participants received 5 mg of LDMTX once a week. For participants who were clinically stable at the Week 1 study visit, the dose of LDMTX was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of LDMTX was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to LDMTX, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of LDMTX, all participants continued taking folic acid for an additional 4 weeks.~LDMTX: LDMTX 5 mg: one 5-mg capsule by mouth once weekly~LDMTX 10 mg: two 5-mg capsules by mouth once weekly~LDMTX 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106533|NCT01949116|O2|Outcome|Placebo|"From study entry through Week 1, participants received 5 mg of placebo once a week. For participants who were clinically stable at the Week 1 study visit, the dose of placebo was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of placebo was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to placebo, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of placebo, all participants continued taking folic acid for an additional 4 weeks.~Placebo: Placebo 5 mg: one 5-mg capsule by mouth once weekly~Placebo 10 mg: two 5-mg capsules by mouth once weekly~Placebo 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106534|NCT01949116|O1|Outcome|Low-dose Methotrexate (LDMTX)|"From study entry through Week 1, participants received 5 mg of LDMTX once a week. For participants who were clinically stable at the Week 1 study visit, the dose of LDMTX was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of LDMTX was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to LDMTX, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of LDMTX, all participants continued taking folic acid for an additional 4 weeks.~LDMTX: LDMTX 5 mg: one 5-mg capsule by mouth once weekly~LDMTX 10 mg: two 5-mg capsules by mouth once weekly~LDMTX 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106535|NCT01949116|O2|Outcome|Placebo|"From study entry through Week 1, participants received 5 mg of placebo once a week. For participants who were clinically stable at the Week 1 study visit, the dose of placebo was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of placebo was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to placebo, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of placebo, all participants continued taking folic acid for an additional 4 weeks.~Placebo: Placebo 5 mg: one 5-mg capsule by mouth once weekly~Placebo 10 mg: two 5-mg capsules by mouth once weekly~Placebo 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106536|NCT01949116|O1|Outcome|Low-dose Methotrexate (LDMTX)|"From study entry through Week 1, participants received 5 mg of LDMTX once a week. For participants who were clinically stable at the Week 1 study visit, the dose of LDMTX was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of LDMTX was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to LDMTX, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of LDMTX, all participants continued taking folic acid for an additional 4 weeks.~LDMTX: LDMTX 5 mg: one 5-mg capsule by mouth once weekly~LDMTX 10 mg: two 5-mg capsules by mouth once weekly~LDMTX 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106537|NCT01949116|O2|Outcome|Placebo|"From study entry through Week 1, participants received either 5 mg of placebo once a week. For participants who were clinically stable at the Week 1 study visit, the dose of placebo was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of placebo was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to placebo, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of placebo, all participants continued taking folic acid for an additional 4 weeks.~Placebo: Placebo 5 mg: one 5-mg capsule by mouth once weekly~Placebo 10 mg: two 5-mg capsules by mouth once weekly~Placebo 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106538|NCT01949116|O1|Outcome|Low-dose Methotrexate (LDMTX)|"From study entry through Week 1, participants received either 5 mg of LDMTX once a week. For participants who were clinically stable at the Week 1 study visit, the dose of LDMTX was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of LDMTX was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to LDMTX, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of LDMTX, all participants continued taking folic acid for an additional 4 weeks.~LDMTX: LDMTX 5 mg: one 5-mg capsule by mouth once weekly~LDMTX 10 mg: two 5-mg capsules by mouth once weekly~LDMTX 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106539|NCT01949116|O2|Outcome|Placebo|"From study entry through Week 1, participants received either 5 mg of placebo once a week. For participants who were clinically stable at the Week 1 study visit, the dose of placebo was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of placebo was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to placebo, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of placebo, all participants continued taking folic acid for an additional 4 weeks.~Placebo: Placebo 5 mg: one 5-mg capsule by mouth once weekly~Placebo 10 mg: two 5-mg capsules by mouth once weekly~Placebo 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106540|NCT01949116|O1|Outcome|Low-dose Methotrexate (LDMTX)|"From study entry through Week 1, participants received either 5 mg of LDMTX once a week. For participants who were clinically stable at the Week 1 study visit, the dose of LDMTX was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of LDMTX was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to LDMTX, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of LDMTX, all participants continued taking folic acid for an additional 4 weeks.~LDMTX: LDMTX 5 mg: one 5-mg capsule by mouth once weekly~LDMTX 10 mg: two 5-mg capsules by mouth once weekly~LDMTX 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106541|NCT01949116|O2|Outcome|Placebo|"From study entry through Week 1, participants received either 5 mg of placebo once a week. For participants who were clinically stable at the Week 1 study visit, the dose of placebo was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of placebo was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to placebo, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of placebo, all participants continued taking folic acid for an additional 4 weeks.~Placebo: Placebo 5 mg: one 5-mg capsule by mouth once weekly~Placebo 10 mg: two 5-mg capsules by mouth once weekly~Placebo 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106542|NCT01949116|O1|Outcome|Low-dose Methotrexate (LDMTX)|"From study entry through Week 1, participants received either 5 mg of LDMTX once a week. For participants who were clinically stable at the Week 1 study visit, the dose of LDMTX was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of LDMTX was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to LDMTX, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of LDMTX, all participants continued taking folic acid for an additional 4 weeks.~LDMTX: LDMTX 5 mg: one 5-mg capsule by mouth once weekly~LDMTX 10 mg: two 5-mg capsules by mouth once weekly~LDMTX 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106551|NCT01949116|E2|Reported Event|Placebo|From study entry through Week 1, participants received either 5 mg of placebo once a week. For participants who were clinically stable at the Week 1 study visit, the dose of placebo was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of placebo was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to placebo, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of placebo, all participants continued taking folic acid for an additional 4 weeks.
107005|NCT01947517|O1|Outcome|Parasol Group|"Randomized to receive Brand A punctal plugs~Parasol Punctal Occluder"
106543|NCT01949116|O2|Outcome|Placebo|"From study entry through Week 1, participants received either 5 mg of placebo once a week. For participants who were clinically stable at the Week 1 study visit, the dose of placebo was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of placebo was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to placebo, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of placebo, all participants continued taking folic acid for an additional 4 weeks.~Placebo: Placebo 5 mg: one 5-mg capsule by mouth once weekly~Placebo 10 mg: two 5-mg capsules by mouth once weekly~Placebo 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106544|NCT01949116|O1|Outcome|Low-dose Methotrexate (LDMTX)|"From study entry through Week 1, participants received either 5 mg of LDMTX once a week. For participants who were clinically stable at the Week 1 study visit, the dose of LDMTX was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of LDMTX was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to LDMTX, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of LDMTX, all participants continued taking folic acid for an additional 4 weeks.~LDMTX: LDMTX 5 mg: one 5-mg capsule by mouth once weekly~LDMTX 10 mg: two 5-mg capsules by mouth once weekly~LDMTX 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106545|NCT01949116|O2|Outcome|Placebo|"From study entry through Week 1, participants received either 5 mg of placebo once a week. For participants who were clinically stable at the Week 1 study visit, the dose of placebo was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of placebo was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to placebo, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of placebo, all participants continued taking folic acid for an additional 4 weeks.~Placebo: Placebo 5 mg: one 5-mg capsule by mouth once weekly~Placebo 10 mg: two 5-mg capsules by mouth once weekly~Placebo 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106546|NCT01949116|O1|Outcome|Low-dose Methotrexate (LDMTX)|"From study entry through Week 1, participants received either 5 mg of LDMTX once a week. For participants who were clinically stable at the Week 1 study visit, the dose of LDMTX was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of LDMTX was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to LDMTX, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of LDMTX, all participants continued taking folic acid for an additional 4 weeks.~LDMTX: LDMTX 5 mg: one 5-mg capsule by mouth once weekly~LDMTX 10 mg: two 5-mg capsules by mouth once weekly~LDMTX 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106547|NCT01949116|O2|Outcome|Placebo|"From study entry through Week 1, participants received either 5 mg of placebo once a week. For participants who were clinically stable at the Week 1 study visit, the dose of placebo was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of placebo was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to placebo, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of placebo, all participants continued taking folic acid for an additional 4 weeks.~Placebo: Placebo 5 mg: one 5-mg capsule by mouth once weekly~Placebo 10 mg: two 5-mg capsules by mouth once weekly~Placebo 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106548|NCT01949116|O1|Outcome|Low-dose Methotrexate (LDMTX)|"From study entry through Week 1, participants received either 5 mg of LDMTX once a week. For participants who were clinically stable at the Week 1 study visit, the dose of LDMTX was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of LDMTX was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to LDMTX, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of LDMTX, all participants continued taking folic acid for an additional 4 weeks.~LDMTX: LDMTX 5 mg: one 5-mg capsule by mouth once weekly~LDMTX 10 mg: two 5-mg capsules by mouth once weekly~LDMTX 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106549|NCT01949116|O2|Outcome|Placebo|"From study entry through Week 1, participants will receive 5 mg of placebo once a week. For participants who are clinically stable at the Week 1 study visit, the dose will be increased to 10 mg once a week through Week 12. For participants who are clinically stable at the Week 12 study visit, the dose will be increased to 15 mg once a week through Week 24. In addition to placebo, all participants will also receive 1 mg of folic acid once a day from study entry through 4 weeks after placebo is discontinued, either at Week 24 or earlier, for any reason.~Placebo: Placebo 5 mg: one 5-mg capsule by mouth once weekly~Placebo 10 mg: two 5-mg capsules by mouth once weekly~Placebo 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106550|NCT01949116|O1|Outcome|Low-dose Methotrexate (LDMTX)|"From study entry through Week 1, participants will receive 5 mg of LDMTX once a week. For participants who are clinically stable at the Week 1 study visit, the dose will be increased to 10 mg once a week through Week 12. For participants who are clinically stable at the Week 12 study visit, the dose will be increased to 15 mg once a week through Week 24. In addition to LDMTX, all participants will also receive 1 mg of folic acid once a day from study entry through 4 weeks after LDMTX is discontinued, either at Week 24 or earlier, for any reason.~LDMTX: LDMTX 5 mg: one 5-mg capsule by mouth once weekly~LDMTX 10 mg: two 5-mg capsules by mouth once weekly~LDMTX 15 mg: three 5-mg capsules by mouth once weekly~Folic acid: 1-mg tablet of folic acid by mouth once a day"
106771|NCT01948908|B3|Baseline|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
106552|NCT01949116|E1|Reported Event|LDMTX|From study entry through Week 1, participants received either 5 mg of LDMTX once a week. For participants who were clinically stable at the Week 1 study visit, the dose of LDMTX was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of LDMTX was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation was re-evaluated at the following study visit. In addition to LDMTX, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of LDMTX, all participants continued taking folic acid for an additional 4 weeks.
106553|NCT01949090|B6|Baseline|Total|Total of all reporting groups
106554|NCT01949090|B5|Baseline|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106555|NCT01949090|B4|Baseline|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106556|NCT01949090|B3|Baseline|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106557|NCT01949090|B2|Baseline|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106558|NCT01949090|B1|Baseline|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106559|NCT01949090|P5|Participant Flow|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106560|NCT01949090|P4|Participant Flow|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106561|NCT01949090|P3|Participant Flow|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106562|NCT01949090|P2|Participant Flow|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106563|NCT01949090|P1|Participant Flow|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106564|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106565|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106566|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106567|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106568|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106569|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106570|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106571|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106572|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106573|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106574|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106575|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
108106|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
106578|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106579|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106580|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106581|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106582|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106583|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106584|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106585|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106586|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106587|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106588|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106589|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106590|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106591|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106592|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106593|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106594|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106595|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106596|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106597|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106598|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106599|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106600|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106601|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106602|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106603|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106604|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106605|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106606|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106607|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106608|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106609|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106610|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106611|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106612|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106613|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106614|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106615|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106616|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106617|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106618|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106619|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106620|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106621|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106622|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106623|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106624|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106625|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106626|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106627|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106628|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106629|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106630|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106631|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106632|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106633|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106634|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106635|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106636|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106637|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106638|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106639|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106640|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106641|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106642|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106643|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106644|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106645|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106646|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106647|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106648|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106649|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106650|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106651|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106652|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106653|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106654|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106655|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106656|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106657|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106658|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106659|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106660|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106661|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106662|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106663|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106664|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106665|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106666|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106667|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106668|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106669|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106670|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106671|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106672|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106673|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106674|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106675|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106676|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106677|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106678|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106679|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106680|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106681|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106682|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106683|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106684|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106685|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106686|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106687|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106688|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106689|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106690|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106691|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106692|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106693|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106694|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106695|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106696|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106697|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106698|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106699|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106700|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106701|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106702|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106703|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106704|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106705|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106706|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106707|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106708|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106709|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106710|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106711|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106712|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106713|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106714|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106715|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106716|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106717|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106718|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106719|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106720|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106721|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106722|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106723|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106724|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106725|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106726|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106727|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106728|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106729|NCT01949090|O5|Outcome|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
106730|NCT01949090|O4|Outcome|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106731|NCT01949090|O3|Outcome|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106732|NCT01949090|O2|Outcome|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106733|NCT01949090|O1|Outcome|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106734|NCT01949090|E5|Reported Event|Placebo Group|Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106735|NCT01949090|E4|Reported Event|GSK2789869A F4 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106736|NCT01949090|E3|Reported Event|GSK2789869A F3 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106737|NCT01949090|E2|Reported Event|GSK2789869A F2 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106738|NCT01949090|E1|Reported Event|GSK2789869A F1 Group|Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
106739|NCT01949051|B1|Baseline|Placebo/Levocabastine|Participants received placebo/ Levo at a dose of 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) into each nostril or 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days each, in a crossover design. Treatment was given in one of six sequences in Periods 1, 2, and 3, (14 to 20 day washout period between treatments): ABC, BCA, CAB, ACB, BAC, CBA (A, Levo 200µg; B, Levo 400µg: C, Placebo). On Day 8 of each treatment period (approximately 12 hours post dosing for treatment A and 24 hours post dosing for treatment B and C), participants entered the environmental exposure chamber (EEC) for a 4-hour period, and the assessments were conducted 12-24 hours post-dose. All participants attended a follow-up visit within 7 to 14 day after their final dose, and the overall duration for participation in the study (screening to follow-up) was 13 weeks.
106740|NCT01949051|P6|Participant Flow|Sequence 6: Placebo, Levo 400µg and Levo 200µg|Participants received placebo, Levo 400µg and Levo 200µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
106741|NCT01949051|P5|Participant Flow|Sequence 5: Levo 400µg, Levo 200µg and Placebo|Participants received Levo 400µg, Levo 200µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
106742|NCT01949051|P4|Participant Flow|Sequence 4: Levo 200µg, Placebo, and Levo 400µg|Participants received Levo 200µg, placebo, and Levo 400µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
106743|NCT01949051|P3|Participant Flow|Sequence 3: Placebo, Levo 200µg and Levo 400µg|Participants received placebo, Levo 200µg and Levo 400µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
106744|NCT01949051|P2|Participant Flow|Sequence 2: Levo 400µg, Placebo and Levo 200µg|Participants received Levo 400µg, placebo and Levo 200µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
106745|NCT01949051|P1|Participant Flow|Sequence 1: Levo 200 µg, Levo 400µg, Placebo|Participants received levocabastine (Levo) 200 micrograms (µg), Levo 400µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg once daily (OD) in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg twice daily (BID) in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
106746|NCT01949051|O3|Outcome|Levocabastine 400µg BID|Participants received levocabastine 400 µg BID as two 50 µg nasal sprays into each nostril in the morning and evening for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
106747|NCT01949051|O2|Outcome|Levocabastine 200µg OD|Participants received levocabastine 200 µg once daily OD as two 50 µg nasal sprays into each nostril in the morning for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
106748|NCT01949051|O1|Outcome|Placebo|Participants received placebo BID as 2 nasal sprays per nostril in the morning and evening for 7 days during one of three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
106749|NCT01949051|O3|Outcome|Levocabastine 400µg BID|Participants received levocabastine 400 µg BID as two 50 µg nasal sprays into each nostril in the morning and evening for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
106750|NCT01949051|O2|Outcome|Levocabastine 200µg OD|Participants received levocabastine 200 µg once daily OD as two 50 µg nasal sprays into each nostril in the morning for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
106751|NCT01949051|O1|Outcome|Placebo|Participants received placebo BID as 2 nasal sprays per nostril in the morning and evening for 7 days during one of three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
106752|NCT01949051|E3|Reported Event|Levocabastine 400µg BID|Participants received levocabastine 400 µg BID as two 50 µg nasal sprays into each nostril in the morning and evening for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
106753|NCT01949051|E2|Reported Event|Levocabastine 200µg OD|Participants received levocabastine 200 µg once daily OD as two 50 µg nasal sprays into each nostril in the morning for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
106754|NCT01949051|E1|Reported Event|Placebo|Participants received placebo BID as 2 nasal sprays per nostril in the morning and evening for 7 days during one of three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
106755|NCT01948947|B3|Baseline|Total|Total of all reporting groups
106756|NCT01948947|B2|Baseline|Sham Transcranial Magnetic Stimulation|"Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.~Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil."
106757|NCT01948947|B1|Baseline|Transcranial Magnetic Stimulation|"Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.~Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex."
106758|NCT01948947|P2|Participant Flow|Sham Transcranial Magnetic Stimulation|"Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.~Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil."
106759|NCT01948947|P1|Participant Flow|Transcranial Magnetic Stimulation|"Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.~Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex."
106760|NCT01948947|O2|Outcome|Sham Transcranial Magnetic Stimulation|"Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.~Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil."
106761|NCT01948947|O1|Outcome|Transcranial Magnetic Stimulation|"Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.~Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex."
106762|NCT01948947|O2|Outcome|Sham Transcranial Magnetic Stimulation|"Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.~Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil."
106763|NCT01948947|O1|Outcome|Transcranial Magnetic Stimulation|"Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.~Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex."
106764|NCT01948947|O2|Outcome|Sham Transcranial Magnetic Stimulation|"Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.~Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil."
106765|NCT01948947|O1|Outcome|Transcranial Magnetic Stimulation|"Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.~Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex."
106766|NCT01948947|O2|Outcome|Sham Transcranial Magnetic Stimulation|"Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.~Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil."
106767|NCT01948947|O1|Outcome|Transcranial Magnetic Stimulation|"Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.~Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex."
106768|NCT01948947|E2|Reported Event|Sham Transcranial Magnetic Stimulation|"Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.~Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil."
106769|NCT01948947|E1|Reported Event|Transcranial Magnetic Stimulation|"Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.~Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex."
106785|NCT01948908|O1|Outcome|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
106786|NCT01948908|E3|Reported Event|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
106787|NCT01948908|E2|Reported Event|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
106788|NCT01948908|E1|Reported Event|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
106789|NCT01948830|B3|Baseline|Total|Total of all reporting groups
106790|NCT01948830|B2|Baseline|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
106791|NCT01948830|B1|Baseline|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
106792|NCT01948830|P2|Participant Flow|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
106793|NCT01948830|P1|Participant Flow|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
106794|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
106795|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
106796|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
106797|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
106798|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
106799|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
106800|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
106801|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
106802|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
106803|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
106804|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
106805|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
106806|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
106807|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
106808|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
106809|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
106810|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
106811|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
106812|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
106813|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
106814|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
106815|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
106816|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
106817|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
106818|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
106819|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
106820|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
106821|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
106822|NCT01948830|E2|Reported Event|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
106823|NCT01948830|E1|Reported Event|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
106824|NCT01948791|B1|Baseline|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
106825|NCT01948791|P1|Participant Flow|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
106826|NCT01948791|O1|Outcome|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
106827|NCT01948791|O1|Outcome|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
106828|NCT01948791|O1|Outcome|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
106829|NCT01948791|O1|Outcome|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
106830|NCT01948791|O1|Outcome|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
106831|NCT01948791|E1|Reported Event|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
106832|NCT01948518|B1|Baseline|Sildenafil|"20 mg of oral sildenafil, single dose at baseline~Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug."
108107|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
106833|NCT01948518|P1|Participant Flow|Sildenafil|"20 mg of oral sildenafil, single dose at baseline~Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug."
106834|NCT01948518|O1|Outcome|Sildenafil|"20 mg of oral sildenafil, single dose at baseline~Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug."
106835|NCT01948518|O1|Outcome|Sildenafil|"20 mg of oral sildenafil, single dose at baseline~Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug."
106836|NCT01948518|E1|Reported Event|Sildenafil|"20 mg of oral sildenafil, single dose at baseline~Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug."
106837|NCT01948375|B3|Baseline|Total|Total of all reporting groups
106838|NCT01948375|B2|Baseline|Real Needle - Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
106839|NCT01948375|B1|Baseline|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
106840|NCT01948375|P2|Participant Flow|Placebo Needle - Real Needle|"Participants will accept acupuncture with pragmatic placebo needle in the first period, and real acupuncture needle in the second period of the trial.~placebo needle - real needle: Participants will accept acupuncture with pragmatic placebo needle in the first period, and real needle in the second period. Acupoints will be needled with no penetration of the skin by placebo needle, while 1 cun by real acupuncture needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants will be asked questions on skin penetration of needles, needling pain and needle sensation. The acupuncture treatment is given every other day. There are three sessions for each kind of needle, six sessions in total for each participant. There is a two-day interval between two kinds of interventions."
106841|NCT01948375|P1|Participant Flow|Real Needle- Placebo Needle|"Participants will accept acupuncture with real acupuncture needle in the first period, and pragmatic placebo needle in the second period of the trial.~real needle- placebo needle: Participants will accept acupuncture with real needle in the first period and pragmatic placebo needle in the second period. Acupoints are to be needled 1 cun by real needle in the first period, and pressed against the skin with no penetration by placebo needle in the second period. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants will be asked questions on skin penetration of needles, needling pain and needle sensation. The acupuncture treatment is given every other day. There are three sessions for each kind of needle, six sessions in total for each participant. There is a two-day interval between two kinds of interventions."
106842|NCT01948375|O2|Outcome|Real Needle- Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
106843|NCT01948375|O1|Outcome|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
106844|NCT01948375|O2|Outcome|Real Needle- Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
106845|NCT01948375|O1|Outcome|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
106846|NCT01948375|O2|Outcome|Real Needle- Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.~real needle- placebo needle: All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
106847|NCT01948375|O1|Outcome|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.~placebo needle - real needle: All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
106848|NCT01948375|O2|Outcome|Real Needle- Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
106849|NCT01948375|O1|Outcome|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
106850|NCT01948375|O2|Outcome|Real Needle- Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
106851|NCT01948375|O1|Outcome|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
106852|NCT01948375|E2|Reported Event|Placebo Needle - Real Needle|"Participants will accept acupuncture with pragmatic placebo needle in the first period, and real acupuncture needle in the second period of the trial.~placebo needle - real needle: Participants will accept acupuncture with pragmatic placebo needle in the first period, and real needle in the second period. Acupoints will be needled with no penetration of the skin by placebo needle, while 1 cun by real acupuncture needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants will be asked questions on skin penetration of needles, needling pain and needle sensation. The acupuncture treatment is given every other day. There are three sessions for each kind of needle, six sessions in total for each participant. There is a two-day interval between two kinds of interventions."
106873|NCT01948193|O1|Outcome|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
107006|NCT01947517|O2|Outcome|Superflex Group|"Randomized to receive Group B punctal plugs~Superflex Punctal Occluder"
106853|NCT01948375|E1|Reported Event|Real Needle- Placebo Needle|"Participants will accept acupuncture with real acupuncture needle in the first period, and pragmatic placebo needle in the second period of the trial.~real needle- placebo needle: Participants will accept acupuncture with real needle in the first period and pragmatic placebo needle in the second period. Acupoints are to be needled 1 cun by real needle in the first period, and pressed against the skin with no penetration by placebo needle in the second period. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants will be asked questions on skin penetration of needles, needling pain and needle sensation. The acupuncture treatment is given every other day. There are three sessions for each kind of needle, six sessions in total for each participant. There is a two-day interval between two kinds of interventions."
106854|NCT01948310|B3|Baseline|Total|Total of all reporting groups
106855|NCT01948310|B2|Baseline|Ranolazine Plus Exercise|"Ranolazine 1000mg pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.~Ranolazine: Comparison of Ranolazine 1000mg twice per day versus placebo twice per day~Aerobic Exercise: Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test)"
106856|NCT01948310|B1|Baseline|Placebo Plus Exercise|"Placebo pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.~Aerobic Exercise: Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test)~Placebo: Comparison of placebo twice per day vs. Ranolazine 1000mg twice per day"
106857|NCT01948310|P2|Participant Flow|Ranolazine Plus Exercise|"Ranolazine 1000mg pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.~Ranolazine: Comparison of Ranolazine 1000mg twice per day versus placebo twice per day~Aerobic Exercise: Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test)"
106858|NCT01948310|P1|Participant Flow|Placebo Plus Exercise|"Placebo pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.~Aerobic Exercise: Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test)~Placebo: Comparison of placebo twice per day vs. Ranolazine 1000mg twice per day"
106859|NCT01948310|O2|Outcome|Ranolazine Plus Exercise|Ranolazine 1000mg pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.
106860|NCT01948310|O1|Outcome|Placebo Plus Exercise|Placebo pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.
106861|NCT01948310|O2|Outcome|Ranolazine Plus Exercise|Ranolazine 1000mg pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.
106862|NCT01948310|O1|Outcome|Placebo Plus Exercise|Placebo pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.
106863|NCT01948310|O2|Outcome|Ranolazine Plus Exercise|Ranolazine 1000mg pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.
106864|NCT01948310|O1|Outcome|Placebo Plus Exercise|Placebo pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.
106865|NCT01948310|E2|Reported Event|Placebo Plus Exercise|"Placebo pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.~Aerobic Exercise: Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test)~Placebo: Comparison of placebo twice per day vs. Ranolazine 1000mg twice per day"
106866|NCT01948310|E1|Reported Event|Ranolazine Plus Exercise|"Ranolazine 1000mg pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.~Ranolazine: Comparison of Ranolazine 1000mg twice per day versus placebo twice per day~Aerobic Exercise: Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test)"
106867|NCT01948193|B1|Baseline|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
106868|NCT01948193|P1|Participant Flow|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP IPV HB PRP T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
106869|NCT01948193|O1|Outcome|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
106870|NCT01948193|O1|Outcome|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP IPV HB PRP T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
106871|NCT01948193|O1|Outcome|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
106872|NCT01948193|O1|Outcome|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
107174|NCT01946243|O3|Outcome|Change|Change = VisQ - Qualitative
106874|NCT01948193|O1|Outcome|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
106875|NCT01948193|E1|Reported Event|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP IPV HB PRP T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
106876|NCT01948141|B1|Baseline|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~nintedanib: Given PO~laboratory biomarker analysis: Correlative studies"
106877|NCT01948141|P1|Participant Flow|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~nintedanib: Given PO~laboratory biomarker analysis: Correlative studies"
106878|NCT01948141|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~nintedanib: Given PO"
106879|NCT01948141|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~nintedanib: Given PO"
106880|NCT01948141|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~nintedanib: Given PO"
106881|NCT01948141|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~nintedanib: Given PO"
106882|NCT01948141|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~nintedanib: Given PO"
106883|NCT01948141|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~nintedanib: Given PO"
106884|NCT01948141|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~nintedanib: Given PO"
106885|NCT01948141|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~nintedanib: Given PO"
106886|NCT01948141|E1|Reported Event|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~nintedanib: Given PO~laboratory biomarker analysis: Correlative studies"
106887|NCT01948076|B3|Baseline|Total|Total of all reporting groups
106888|NCT01948076|B2|Baseline|Resident With GE Vscan|residents with augmentation of physical exam by ultrasound
106889|NCT01948076|B1|Baseline|Resident Without GE Vscan|baseline physical exam use
106890|NCT01948076|P2|Participant Flow|Intervention Group|Received training and access to ultrasounds. During assessment performed physical exam first followed by ultrasound exam
106891|NCT01948076|P1|Participant Flow|Control Group|Performed only physical exam with no access to ultrasoun
106892|NCT01948076|O2|Outcome|Intervention Group (Using Ultrasound)|residents with augmentation of physical exam by ultrasound
106893|NCT01948076|O1|Outcome|Intervention Group (Using Physical Exam Only)|Baseline physical exam prior to using the ultrasound
106894|NCT01948076|O2|Outcome|Resident With GE Vscan|residents with augmentation of physical exam by ultrasound
106895|NCT01948076|O1|Outcome|Resident Without GE Vscan|baseline physical exam use
106896|NCT01948076|E2|Reported Event|Resident With GE Vscan|residents with augmentation of physical exam by ultrasound
106897|NCT01948076|E1|Reported Event|Resident Without GE Vscan|baseline physical exam use
106898|NCT01948063|B3|Baseline|Total|Total of all reporting groups
106899|NCT01948063|B2|Baseline|Ubiquinol|Patients will receive 200mg of Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.
106900|NCT01948063|B1|Baseline|Placebo|Patients will receive a placebo pill or a liquid placebo. The liquid placebo is 50 milliliters of Ensure (a dietary supplement). Placebo will be given every 12 hours for 7 days or until hospital discharge.
106901|NCT01948063|P2|Participant Flow|Ubiquinol|Depending on the patient's ability to swallow pills, patients in the experimental group will receive 200mg of Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.
106902|NCT01948063|P1|Participant Flow|Placebo|Depending on the patient's ability to swallow pills, patients in the control group will receive a placebo pill or a liquid placebo, which is 50 milliliters of Ensure (a dietary supplement). This will be given every 12 hours for 7 days or until hospital discharge.
106903|NCT01948063|O2|Outcome|Ubiquinol|Patients will receive 200mg of Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.
106904|NCT01948063|O1|Outcome|Placebo|Patients will receive a placebo pill or a liquid placebo. The liquid placebo is 50 milliliters of Ensure (a dietary supplement). Placebo will be given every 12 hours for 7 days or until hospital discharge.
106905|NCT01948063|E2|Reported Event|Placebo|Depending on the patient's ability to swallow pills, patients in the control group will receive a placebo pill or a liquid placebo, which is 50 milliliters of Ensure (a dietary supplement). This will be given every 12 hours for 7 days or until hospital discharge.
106906|NCT01948063|E1|Reported Event|Ubiquinol|Depending on the patient's ability to swallow pills, patients in the experimental group will receive 200mg of Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.
106907|NCT01948050|B3|Baseline|Total|Total of all reporting groups
106908|NCT01948050|B2|Baseline|Sham tDCS|sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days.
106909|NCT01948050|B1|Baseline|Real tDCS Stimulation|non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
106910|NCT01948050|P2|Participant Flow|Sham tDCS|sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days.
106911|NCT01948050|P1|Participant Flow|Real tDCS Stimulation|non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
106912|NCT01948050|O2|Outcome|Sham tDCS|sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days.
106913|NCT01948050|O1|Outcome|Real tDCS Stimulation|non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
106914|NCT01948050|E2|Reported Event|Sham tDCS|sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days.
106915|NCT01948050|E1|Reported Event|Real tDCS Stimulation|non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
106916|NCT01947946|B4|Baseline|Total|Total of all reporting groups
106917|NCT01947946|B3|Baseline|Placebo|A (Dummy) injection
106918|NCT01947946|B2|Baseline|Benra 30 Mg-Placebo q.8 Weeks|Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
106919|NCT01947946|B1|Baseline|Benra 30 mg q.4 Weeks|Fixed 30 mg dose of benralizumab every 4 weeks.
106920|NCT01947946|P3|Participant Flow|Placebo|A (Dummy) injection
106921|NCT01947946|P2|Participant Flow|Benra 30 Mg-Placebo q.8 Weeks|Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
106922|NCT01947946|P1|Participant Flow|Benra 30 mg q.4 Weeks|Fixed 30 mg dose of benralizumab every 4 weeks.
106923|NCT01947946|O3|Outcome|Placebo|A (Dummy) injection
106924|NCT01947946|O2|Outcome|Benra 30 Mg-Placebo q.8 Weeks|Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
106925|NCT01947946|O1|Outcome|Benra 30 mg q.4 Weeks|Fixed 30 mg dose of benralizumab every 4 weeks.
106926|NCT01947946|E3|Reported Event|Placebo|A (Dummy) injection
106927|NCT01947946|E2|Reported Event|Benra 30 Mg-Placebo q.8 Weeks|Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
106928|NCT01947946|E1|Reported Event|Benra 30 mg q.4 Weeks|Fixed 30 mg dose of benralizumab every 4 weeks.
106929|NCT01947907|B5|Baseline|Total|Total of all reporting groups
106930|NCT01947907|B4|Baseline|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
106931|NCT01947907|B3|Baseline|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106932|NCT01947907|B2|Baseline|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106933|NCT01947907|B1|Baseline|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106934|NCT01947907|P4|Participant Flow|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
106935|NCT01947907|P3|Participant Flow|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106936|NCT01947907|P2|Participant Flow|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106937|NCT01947907|P1|Participant Flow|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106938|NCT01947907|O4|Outcome|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
106939|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106940|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106941|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106942|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106943|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106944|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106945|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106946|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106947|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106948|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106949|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106950|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106951|NCT01947907|O4|Outcome|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
106952|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106953|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106954|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106955|NCT01947907|O4|Outcome|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
106956|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106957|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106958|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106959|NCT01947907|O4|Outcome|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
106960|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106961|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106962|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106963|NCT01947907|O4|Outcome|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
106964|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106965|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106966|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106967|NCT01947907|O4|Outcome|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
106968|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106969|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106970|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106971|NCT01947907|E4|Reported Event|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
106972|NCT01947907|E3|Reported Event|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106973|NCT01947907|E2|Reported Event|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106974|NCT01947907|E1|Reported Event|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
106975|NCT01947855|B4|Baseline|Total|Total of all reporting groups
106976|NCT01947855|B3|Baseline|Empagliflozin 25 mg|Empagliflozin 25mg oral administration once daily
106977|NCT01947855|B2|Baseline|Empagliflozin 10 mg|Empagliflozin 10 mg oral administration once daily
106978|NCT01947855|B1|Baseline|Placebo|Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
106979|NCT01947855|P3|Participant Flow|Empagliflozin 25 mg|Empagliflozin 25mg oral administration once daily
106980|NCT01947855|P2|Participant Flow|Empagliflozin 10 mg|Empagliflozin 10 mg oral administration once daily
106981|NCT01947855|P1|Participant Flow|Placebo|Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
106982|NCT01947855|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25mg oral administration once daily
106983|NCT01947855|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg oral administration once daily
106984|NCT01947855|O1|Outcome|Placebo|Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
106985|NCT01947855|E3|Reported Event|Empagliflozin 25 mg|Empagliflozin 25mg oral administration once daily
106986|NCT01947855|E2|Reported Event|Empagliflozin 10 mg|Empagliflozin 10 mg oral administration once daily
106987|NCT01947855|E1|Reported Event|Placebo|Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
106988|NCT01947582|B1|Baseline|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
106989|NCT01947582|P1|Participant Flow|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
106990|NCT01947582|O1|Outcome|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
106991|NCT01947582|O1|Outcome|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
106992|NCT01947582|O1|Outcome|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
106993|NCT01947582|O1|Outcome|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
106994|NCT01947582|E1|Reported Event|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
106995|NCT01947517|B3|Baseline|Total|Total of all reporting groups
106996|NCT01947517|B2|Baseline|Superflex Group|"Randomized to receive Group B punctal plugs~Superflex Punctal Occluder"
106997|NCT01947517|B1|Baseline|Parasol Group|"Randomized to receive Brand A punctal plugs~Parasol Punctal Occluder"
106998|NCT01947517|P2|Participant Flow|Superflex Group|"Randomized to receive Group B punctal plugs~Superflex Punctal Occluder"
106999|NCT01947517|P1|Participant Flow|Parasol Group|"Randomized to receive Brand A punctal plugs~Parasol Punctal Occluder"
107007|NCT01947517|O1|Outcome|Parasol Group|"Randomized to receive Brand A punctal plugs~Parasol Punctal Occluder"
107008|NCT01947517|O2|Outcome|Superflex Group|"Randomized to receive Group B punctal plugs~Superflex Punctal Occluder"
107009|NCT01947517|O1|Outcome|Parasol Group|"Randomized to receive Brand A punctal plugs~Parasol Punctal Occluder"
107010|NCT01947517|E2|Reported Event|Superflex Group|"Randomized to receive Group B punctal plugs~Superflex Punctal Occluder"
107011|NCT01947517|E1|Reported Event|Parasol Group|"Randomized to receive Brand A punctal plugs~Parasol Punctal Occluder"
107012|NCT01947491|B5|Baseline|Total|Total of all reporting groups
107013|NCT01947491|B4|Baseline|Vehicle Lotion|"Vehicle Lotion twice daily for 28 days~Vehicle Lotion"
107014|NCT01947491|B3|Baseline|Comp01 Lotion|"Comp01 Lotion twice daily for 14 days~Comp01 Lotion"
107015|NCT01947491|B2|Baseline|Vehicle Spray|"Vehicle Spray twice daily for 28 days~Vehicle Spray"
107016|NCT01947491|B1|Baseline|DFD01 Spray|"DFD01 Spray twice daily for 28 days~DFD01 Spray"
107017|NCT01947491|P4|Participant Flow|Vehicle Lotion|"Vehicle Lotion twice daily for 28 days~Vehicle Lotion"
107018|NCT01947491|P3|Participant Flow|Comp01 Lotion|"Comp01 Lotion twice daily for 14 days~Comp01 Lotion"
107019|NCT01947491|P2|Participant Flow|Vehicle Spray|"Vehicle Spray twice daily for 28 days~Vehicle Spray"
107020|NCT01947491|P1|Participant Flow|DFD01 Spray|"DFD01 Spray twice daily for 28 days~DFD01 Spray"
107021|NCT01947491|O4|Outcome|Vehicle Lotion|"Vehicle Lotion twice daily for 28 days~Vehicle Lotion"
107022|NCT01947491|O3|Outcome|Comp01 Lotion|"Comp01 Lotion twice daily for 14 days~Comp01 Lotion"
107023|NCT01947491|O2|Outcome|Vehicle Spray|"Vehicle Spray twice daily for 28 days~Vehicle Spray"
107024|NCT01947491|O1|Outcome|DFD01 Spray|"DFD01 Spray twice daily for 28 days~DFD01 Spray"
107025|NCT01947491|E4|Reported Event|Vehicle Lotion|"Vehicle Lotion twice daily for 28 days~Vehicle Lotion"
107026|NCT01947491|E3|Reported Event|Comp01 Lotion|"Comp01 Lotion twice daily for 14 days~Comp01 Lotion"
107027|NCT01947491|E2|Reported Event|Vehicle Spray|"Vehicle Spray twice daily for 28 days~Vehicle Spray"
107028|NCT01947491|E1|Reported Event|DFD01 Spray|"DFD01 Spray twice daily for 28 days~DFD01 Spray"
107029|NCT01947335|B3|Baseline|Total|Total of all reporting groups
107030|NCT01947335|B2|Baseline|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention~IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
107031|NCT01947335|B1|Baseline|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
107032|NCT01947335|P2|Participant Flow|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention~IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
107033|NCT01947335|P1|Participant Flow|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
107034|NCT01947335|O2|Outcome|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention~IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
107035|NCT01947335|O1|Outcome|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
107036|NCT01947335|O2|Outcome|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention~IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
107037|NCT01947335|O1|Outcome|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
107038|NCT01947335|O2|Outcome|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention~IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
107039|NCT01947335|O1|Outcome|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
107040|NCT01947335|E2|Reported Event|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention~IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
107041|NCT01947335|E1|Reported Event|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
107042|NCT01947153|B1|Baseline|All Subjects|All subjects treated with 5 mg linagliptin / 1000 mg metformin as fixed dose combination or as free dose combination.
107043|NCT01947153|P2|Participant Flow|Free Combination First, Then Fixed Dose Combination|Free combination: one 5mg linagliptin tablet and one 1000mg metformin tablet first; then 5 mg linagliptin / 1000mg metformin given as two 2.5mg linagliptin / 500mg metformin fixed dose combination (FDC) tablets
107044|NCT01947153|P1|Participant Flow|Fixed Dose Combination First, Then Free Combination|5 mg linagliptin / 1000mg metformin given as two 2.5mg linagliptin / 500mg metformin fixed dose combination (FDC) tablets first; then free combination: one 5mg linagliptin tablet and one 1000mg metformin tablet
107045|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin~Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
107046|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin~Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
107047|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin~Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
107048|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin~Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
107049|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin~Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
107050|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin~Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
107051|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin~Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
107052|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin~Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
107053|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin~Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
107054|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin~Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
107055|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin~Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
107056|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin~Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
107057|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin~Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
107058|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin~Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
107059|NCT01947153|E2|Reported Event|Free Combination|"Linagliptin and Metformin~Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
107060|NCT01947153|E1|Reported Event|Fixed Dose Combination|"Linagliptin/Metformin~Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
107061|NCT01947127|B3|Baseline|Total|Total of all reporting groups
107062|NCT01947127|B2|Baseline|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
107063|NCT01947127|B1|Baseline|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
107064|NCT01947127|P2|Participant Flow|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
107065|NCT01947127|P1|Participant Flow|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
107066|NCT01947127|O2|Outcome|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
107067|NCT01947127|O1|Outcome|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
107068|NCT01947127|O2|Outcome|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
107069|NCT01947127|O1|Outcome|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
107070|NCT01947127|O2|Outcome|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
107071|NCT01947127|O1|Outcome|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
107072|NCT01947127|E2|Reported Event|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
107073|NCT01947127|E1|Reported Event|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
107074|NCT01946542|B3|Baseline|Total|Total of all reporting groups
107075|NCT01946542|B2|Baseline|Beet Juice Concentrate First, Then Placebo|"Testing visit 1: Participants are given a single dose of beet juice concentrate, roughly 70 mL.~Testing Visit 2: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink."
107076|NCT01946542|B1|Baseline|Placebo First Then Beet Juice Concentrate|"Testing visit 1: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink.~Testing visit 2: Participants are given a single dose of beet juice concentrate, roughly 70 mL."
107077|NCT01946542|P2|Participant Flow|Beet Juice Concentrate First, Then Placebo|"Testing visit 1: Participants are given a single dose of beet juice concentrate, roughly 70 mL.~Testing Visit 2: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink."
107078|NCT01946542|P1|Participant Flow|Placebo First Then Beet Juice Concentrate|"Testing visit 1: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink.~Testing visit 2: Participants are given a single dose of beet juice concentrate, roughly 70 mL."
107079|NCT01946542|O2|Outcome|Beet Juice Concentrate First, Then Placebo|"Testing visit 1: Participants are given a single dose of beet juice concentrate, roughly 70 mL.~Testing Visit 2: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink."
107080|NCT01946542|O1|Outcome|Placebo First Then Beet Juice Concentrate|"Testing visit 1: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink.~Testing visit 2: Participants are given a single dose of beet juice concentrate, roughly 70 mL."
107081|NCT01946542|O2|Outcome|Beet Juice Concentrate First, Then Placebo|"Testing visit 1: Participants are given a single dose of beet juice concentrate, roughly 70 mL.~Testing Visit 2: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink."
107082|NCT01946542|O1|Outcome|Placebo First Then Beet Juice Concentrate|"Testing visit 1: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink.~Testing visit 2: Participants are given a single dose of beet juice concentrate, roughly 70 mL."
107083|NCT01946542|E2|Reported Event|Beet Juice Concentrate|
107084|NCT01946542|E1|Reported Event|Placebo|
107085|NCT01946529|B4|Baseline|Total|Total of all reporting groups
107086|NCT01946529|B3|Baseline|Group B (High Risk) - DSRCT|Group B participants with a diagnosis of Desmoplastic Small Round Cell Tumor (DSRCT).
107087|NCT01946529|B2|Baseline|Group B (High Risk) - ESFT|Group B participants with a diagnosis of Ewing Sarcoma Family of Tumor (ESFT).
107088|NCT01946529|B1|Baseline|Group A (Standard Risk)|Participants will receive vincristine, doxorubicin, cyclophosphamide, ifosfamide and etoposide. Doxorubicin will be omitted following a total cumulative dose of 375 mg/m^2. Depending on the size and location of the participant's tumor, they will have surgery alone, radiation alone, or surgery followed by radiation. Local control measures (surgery and/or radiation therapy) will be instituted after 6 courses of chemotherapy. Total duration of treatment is approximately 29 weeks.
107089|NCT01946529|P3|Participant Flow|Group B (High Risk) - DSRCT|Group B participants with a diagnosis of Desmoplastic Small Round Cell Tumor (DSRCT).
107090|NCT01946529|P2|Participant Flow|Group B (High Risk) - ESFT|Group B participants with a diagnosis of Ewing Sarcoma Family of Tumor (ESFT).
107091|NCT01946529|P1|Participant Flow|Group A (Standard Risk)|Participants will receive vincristine, doxorubicin, cyclophosphamide, ifosfamide and etoposide. Doxorubicin will be omitted following a total cumulative dose of 375 mg/m^2. Depending on the size and location of the participant's tumor, they will have surgery alone, radiation alone, or surgery followed by radiation. Local control measures (surgery and/or radiation therapy) will be instituted after 6 courses of chemotherapy. Total duration of treatment is approximately 29 weeks.
107092|NCT01946529|O1|Outcome|Group B (High Risk) - ESFT|Participants received vincristine, doxorubicin, cyclophosphamide, ifosfamide, and etoposide. Patients with measurable disease were eligible to receive irinotecan, temozolomide, and temsirolimus. Additionally, all patients were eligible to receive a maintenance therapy at the end of treatment including bevacizumab and sorafenib. Depending on the size and location of the participant's tumor, they had surgery alone, radiation alone, or surgery followed by radiation.
107175|NCT01946243|O2|Outcome|VisQ|Quantitation as an adjunct to qualitative scan interpretation
107176|NCT01946243|O1|Outcome|Qualitative|Qualitative scan interpretation only
107093|NCT01946529|E4|Reported Event|Group B (High Risk) - Total|"All Group B High Risk participants with ESFT or DSRCT.~Participants received vincristine, doxorubicin, cyclophosphamide, ifosfamide, and etoposide. Patients with measurable disease were eligible to receive irinotecan, temozolomide, and temsirolimus. Additionally, all patients were eligible to receive a maintenance therapy at the end of treatment including bevacizumab and sorafenib. Depending on the size and location of the participant's tumor, they had surgery alone, radiation alone, or surgery followed by radiation."
107094|NCT01946529|E3|Reported Event|Group B (High Risk) - DSRCT|Group B participants with a diagnosis of Desmoplastic Small Round Cell Tumor (DSRCT).
107095|NCT01946529|E2|Reported Event|Group B (High Risk) - ESFT|Group B participants with a diagnosis of Ewing Sarcoma Family of Tumor (ESFT).
107096|NCT01946529|E1|Reported Event|Group A (Standard Risk)|Participants will receive vincristine, doxorubicin, cyclophosphamide, ifosfamide and etoposide. Doxorubicin will be omitted following a total cumulative dose of 375 mg/m^2. Depending on the size and location of the participant's tumor, they will have surgery alone, radiation alone, or surgery followed by radiation. Local control measures (surgery and/or radiation therapy) will be instituted after 6 courses of chemotherapy. Total duration of treatment is approximately 29 weeks.
107097|NCT01946438|B5|Baseline|Total|Total of all reporting groups
107098|NCT01946438|B4|Baseline|Elderly Fluzone® High Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® High Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
107099|NCT01946438|B3|Baseline|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
107100|NCT01946438|B2|Baseline|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a 0.1 mL dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
107101|NCT01946438|B1|Baseline|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
107102|NCT01946438|P4|Participant Flow|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
107103|NCT01946438|P3|Participant Flow|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
107104|NCT01946438|P2|Participant Flow|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a 0.1 mL dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
107105|NCT01946438|P1|Participant Flow|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
107106|NCT01946438|O4|Outcome|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
107107|NCT01946438|O3|Outcome|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
107108|NCT01946438|O2|Outcome|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a 0.1 mL dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
107109|NCT01946438|O1|Outcome|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
107110|NCT01946438|O4|Outcome|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
107111|NCT01946438|O3|Outcome|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
107112|NCT01946438|O2|Outcome|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
107113|NCT01946438|O1|Outcome|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
107114|NCT01946438|O4|Outcome|Elderly Fluzone® High Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
107115|NCT01946438|O3|Outcome|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
107116|NCT01946438|O2|Outcome|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
107117|NCT01946438|O1|Outcome|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
107118|NCT01946438|O4|Outcome|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
107119|NCT01946438|O3|Outcome|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
107120|NCT01946438|O2|Outcome|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
107121|NCT01946438|O1|Outcome|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Vaccine 2013-2014 formulation
107177|NCT01946243|O3|Outcome|Change|Change = VisQ - Qualitative
107122|NCT01946438|O4|Outcome|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
107123|NCT01946438|O3|Outcome|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
107124|NCT01946438|O2|Outcome|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
107125|NCT01946438|O1|Outcome|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
107126|NCT01946438|E4|Reported Event|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
107127|NCT01946438|E3|Reported Event|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
107128|NCT01946438|E2|Reported Event|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
107129|NCT01946438|E1|Reported Event|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
107130|NCT01946425|B3|Baseline|Total|Total of all reporting groups
107131|NCT01946425|B2|Baseline|Age 3 to <9 Years Group|Participants 3 years to <9 years of age who received a 0.5 mL dose of Fluzone® Quadrivalent Influenza Virus Vaccine (2013-2014 formulation)
107132|NCT01946425|B1|Baseline|Age 6 to <36 Months Group|Participants 6 months to <36 months of age who received a 0.25 mL dose of Fluzone® Quadrivalent Influenza Virus Vaccine (2013-2014 formulation)
107133|NCT01946425|P2|Participant Flow|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation)
107134|NCT01946425|P1|Participant Flow|Age 6 Months to <36 Months Group|Participants 6 months to <36 months of age who received a 0.25 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation)
107135|NCT01946425|O2|Outcome|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation)
107136|NCT01946425|O1|Outcome|Age 6 Months to <36 Months Group|Participants 6 months to <36 months of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
107137|NCT01946425|O2|Outcome|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
107138|NCT01946425|O1|Outcome|Age 6 Months to <36 Months Group|Participants 6 months to <36 months of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
107139|NCT01946425|O2|Outcome|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
107140|NCT01946425|O1|Outcome|Age 6 Months to <36 Months Group|Participants 6 months to <36 months of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
107141|NCT01946425|O2|Outcome|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
107142|NCT01946425|O1|Outcome|Age 6 Months to <36 Months Group|Participants 6 months to <36 months of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
107143|NCT01946425|O2|Outcome|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
107144|NCT01946425|O1|Outcome|Age 6 Months to <36 Months Group|Participants 6 months to <36 months of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
107145|NCT01946425|E2|Reported Event|Age 3 Years to <9 Years Group|Participants age 3 years to < 9 years of age that received Fluzone® Quadrivalent Influenza Vaccine (2013-2014 formulation)
107146|NCT01946425|E1|Reported Event|Age 6 Months to <36 Months Group|Participants 6 months to < 36 months of age that received Fluzone® Quadrivalent Influenza Vaccine (2013-2014 formulation)
107147|NCT01946412|B1|Baseline|Ivacaftor|Participants received ivacaftor 50 mg or 75 mg or 150 mg based on body weight and age. Ivacaftor 50 mg administered q12h for participants aged 2 to < 6 years and weighing <14 kg, ivacaftor 75 mg q12h for participants aged 2 to <6 years and weighing >= 14 kg and ivacaftor 150 mg q12h for participants >=6 years.
107148|NCT01946412|P1|Participant Flow|Ivacaftor|Participants received ivacaftor 50 milligram (mg) or 75 mg or 150 mg based on body weight and age. Ivacaftor 50 mg administered every 12 hours (q12h) for participants aged 2 to less than (<) 6 years and weighing <14 kilograms (kg), ivacaftor 75 mg q12h for participants aged 2 to <6 years and weighing greater than or equal to (>=) 14 kg and ivacaftor 150 mg q12h for participants >=6 years.
107149|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
107150|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
107151|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
107178|NCT01946243|O2|Outcome|VisQ|Quantitation as an adjunct to qualitative scan interpretation
107179|NCT01946243|O1|Outcome|Qualitative|Qualitative scan interpretation only
107180|NCT01946243|O3|Outcome|Change|Change = VisQ - Qualitative
107152|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
107153|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
107154|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
107155|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
107156|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
107157|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
107158|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
107159|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
107160|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
107161|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
107162|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
107163|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
107164|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
107165|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
107166|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
107167|NCT01946412|E2|Reported Event|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
107168|NCT01946412|E1|Reported Event|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
107169|NCT01946243|B1|Baseline|Florbetapir PET Scans|No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A07[NCT00857415]/A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A07/A16) and 50 randomly selected non-autopsy scans (A17).
107170|NCT01946243|P1|Participant Flow|Florbetapir PET Scans|No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A07[NCT00857415]/A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A07/A16) and 50 randomly selected non-autopsy scans (A17).
107171|NCT01946243|O3|Outcome|Change|Change = VisQ - Qualitative
107172|NCT01946243|O2|Outcome|VisQ|Quantitation as an adjunct to qualitative scan interpretation
107173|NCT01946243|O1|Outcome|Qualitative|Qualitative scan interpretation only
107189|NCT01946243|E1|Reported Event|Florbetapir PET Scans|No subjects received florbetapir in this study. This study consisted of re-reads of scans previously acquired in other clinical studies (A07/A16 and A17).
107190|NCT01946178|B1|Baseline|All Treated Patients|All patients who underwent treatment with the device
107191|NCT01946178|P1|Participant Flow|All Treated Patients|All patients who underwent treatment with the device
107192|NCT01946178|O2|Outcome|Entire Validation Cohort|The Validation Cohort includes the last 36 patients treated in the study sequence. Treatments in the Validation Cohort were used to refine and validate the final HIFU parameters for uterine fibroid treatment with the device. Outcomes are reported for all 36 patients in the Validation Cohort.
107193|NCT01946178|O1|Outcome|Entire Development Cohort|The Development Cohort includes the first 37 patients treated in the study sequence. Treatments in the Development Cohort were used for dose-ranging purposes to develop the most appropriate HIFU parameters for uterine fibroid treatment with the device. Outcomes are reported for all 37 patients in the Development Cohort.
107194|NCT01946178|O2|Outcome|Validation Cohort With NPVs Observed|"The Validation Cohort includes the last 36 patients treated in the study sequence. Treatments in the Validation Cohort were used to refine and validate the final HIFU parameters for uterine fibroid treatment with the device. Outcomes are reported for the 35 out of 36 patients (97.2%) in the Validation Cohort with NPVs observed following treatment.~Overall, 68 out of 73 patients (93.2%) in the entire study had NPVs observed following treatment."
107195|NCT01946178|O1|Outcome|Development Cohort With NPVs Observed|"The Development Cohort includes the first 37 patients treated in the study sequence. Treatments in the Development Cohort were used for dose-ranging purposes to develop the most appropriate HIFU parameters for uterine fibroid treatment with the device. Outcomes are reported for the 33 out of 37 patients (89.2%) in the Development Cohort with NPVs observed following treatment.~Overall, 68 out of 73 patients (93.2%) in the entire study had NPVs observed following treatment."
107196|NCT01946178|O1|Outcome|All Treated Patients|All patients who underwent treatment with the device
107197|NCT01946178|E1|Reported Event|All Treated Patients|All patients who underwent treatment with the device
107198|NCT01946126|B3|Baseline|Total|Total of all reporting groups
107199|NCT01946126|B2|Baseline|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
107200|NCT01946126|B1|Baseline|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
107201|NCT01946126|P2|Participant Flow|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
107202|NCT01946126|P1|Participant Flow|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
107203|NCT01946126|O2|Outcome|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
107204|NCT01946126|O1|Outcome|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
107205|NCT01946126|O2|Outcome|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
107206|NCT01946126|O1|Outcome|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
107207|NCT01946126|O2|Outcome|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
107208|NCT01946126|O1|Outcome|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
107209|NCT01946126|O2|Outcome|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
107210|NCT01946126|O1|Outcome|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
107211|NCT01946126|O2|Outcome|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
107212|NCT01946126|O1|Outcome|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
107213|NCT01946126|E2|Reported Event|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
107214|NCT01946126|E1|Reported Event|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
107215|NCT01945970|B1|Baseline|Study Subjects|All six treatment orders combined
107216|NCT01945970|P6|Participant Flow|Placebo - Black Tea - Positive Control|"Subjects treated in the order Placebo - wash out - Black tea - wash out- Positive control.~Treatments each lasted one week and were separated by a one week washout."
107217|NCT01945970|P5|Participant Flow|Placebo- Positive Control - Black Tea|"Subjects treated in the order Placebo - wash out - Positive control - wash out- Black tea.~Treatments each lasted one week and were separated by a one week washout."
107218|NCT01945970|P4|Participant Flow|Positive Control - Placebo - Black Tea|"Subjects treated in the order Positive control - wash out - Placebo - wash out - Black tea.~Treatments each lasted one week and were separated by a one week washout."
107219|NCT01945970|P3|Participant Flow|Positive Control - Black Tea - Placebo|"Subjects treated in the order Positive control - wash out - Black tea - wash out - Placebo.~Treatments each lasted one week and were separated by a one week washout."
107220|NCT01945970|P2|Participant Flow|Black Tea - Placebo - Positive Control|"Subjects treated in the order Black tea - wash out- Placebo control - wash out - Positive control.~Treatments each lasted one week and were separated by a one week washout."
107221|NCT01945970|P1|Participant Flow|Black Tea - Positive Control - Placebo|"Subjects treated in the order Black tea - wash out- Positive control - wash out - Placebo.~Treatments each lasted one week and were separated by a one week washout."
107223|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
107224|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
107225|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
107226|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
107227|NCT01945970|O1|Outcome|Postive Control Beverage|Participant when they received the positive control
107228|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
107229|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back tea
107230|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
107231|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back tea
107232|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
107233|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back tea
107234|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
107235|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
107236|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
107237|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
107238|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
107239|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back tea
107240|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
107241|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back tea
107242|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
107243|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
107244|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
107245|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
107246|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
107247|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
107248|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
107249|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back tea
107250|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
107251|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back Tea
107252|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
107253|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back Tea
107254|NCT01945970|E3|Reported Event|Placebo|Food grade colouring, artificial tea flavour and an amount of caffeine matched to the caffeine in the Black tea extract
107255|NCT01945970|E2|Reported Event|Positive Control|Spray dried aqueous extract of a batch of tea extract that has shown to improve Flow Mediated Dilation previously
107256|NCT01945970|E1|Reported Event|Black Tea Extract|Spray dried aqueous extract of a representative batch of black tea
107257|NCT01945944|B3|Baseline|Total|Total of all reporting groups
107258|NCT01945944|B2|Baseline|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%)"
107259|NCT01945944|B1|Baseline|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline)"
107260|NCT01945944|P2|Participant Flow|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%)"
107261|NCT01945944|P1|Participant Flow|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline)"
107262|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
107263|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
107264|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
107265|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
107266|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
107267|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
107268|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
107269|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
107270|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
107271|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
107272|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
107273|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
107274|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
107275|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
107276|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
108108|NCT01941498|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
107277|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
107278|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%)"
107279|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline)"
107280|NCT01945944|E2|Reported Event|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%)"
107281|NCT01945944|E1|Reported Event|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline)"
107282|NCT01945489|B3|Baseline|Total|Total of all reporting groups
107283|NCT01945489|B2|Baseline|Placebo/OnabotulinumtoxinA|Placebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
107284|NCT01945489|B1|Baseline|OnabotulinumtoxinA|OnabotulinumtoxinA (BOTOX®) 100U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
107285|NCT01945489|P2|Participant Flow|Placebo/OnabotulinumtoxinA|Placebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
107286|NCT01945489|P1|Participant Flow|OnabotulinumtoxinA|OnabotulinumtoxinA (BOTOX®) 100U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
107287|NCT01945489|O2|Outcome|Placebo/OnabotulinumtoxinA|Placebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
107288|NCT01945489|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (BOTOX®) 100U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
107289|NCT01945489|O2|Outcome|Placebo/OnabotulinumtoxinA|Placebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
107290|NCT01945489|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (BOTOX®) 100U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
107291|NCT01945489|O2|Outcome|Placebo/OnabotulinumtoxinA|Placebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
107292|NCT01945489|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (BOTOX®) 100U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
107293|NCT01945489|O2|Outcome|Placebo/OnabotulinumtoxinA|Placebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
107294|NCT01945489|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (BOTOX®) 100U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
107295|NCT01945489|O2|Outcome|Placebo/OnabotulinumtoxinA|Placebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
107296|NCT01945489|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (BOTOX®) 100U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
107297|NCT01945489|O2|Outcome|Placebo/OnabotulinumtoxinA|Placebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
107298|NCT01945489|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (BOTOX®) 100U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
107299|NCT01945489|E3|Reported Event|OnabotulinumtoxinA (Cycle 2)|OnabotulinumtoxinA (BOTOX®) 100 U injected into the detrusor at Day 1 in Cycle 2.
107300|NCT01945489|E2|Reported Event|Placebo (Cycle 1)|Placebo (Normal saline) injected into the detrusor on Day 1 of Cycle 1.
107301|NCT01945489|E1|Reported Event|OnabotulinumtoxinA (Cycle 1)|OnabotulinumtoxinA (BOTOX®) 100 U injected into the detrusor at Day 1 in Cycle 1.
107302|NCT01945294|B4|Baseline|Total|Total of all reporting groups
107303|NCT01945294|B3|Baseline|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
107304|NCT01945294|B2|Baseline|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
107305|NCT01945294|B1|Baseline|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
107306|NCT01945294|P4|Participant Flow|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
107307|NCT01945294|P3|Participant Flow|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
107308|NCT01945294|P2|Participant Flow|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
107378|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
107309|NCT01945294|P1|Participant Flow|All Treated Participants|All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA]) or allocation to Arm 3 (participants with detectable HCV RNA).
107310|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
107311|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
107312|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
107313|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
107314|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
107315|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
107316|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
107317|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
107318|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
107319|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
107320|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
107321|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
107322|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
107323|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
107324|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
107325|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
107326|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
107327|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
107328|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
108109|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
107329|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
107330|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
107331|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
107332|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
107333|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
107334|NCT01945294|E3|Reported Event|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
107335|NCT01945294|E2|Reported Event|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
107336|NCT01945294|E1|Reported Event|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
107337|NCT01945242|B3|Baseline|Total|Total of all reporting groups
107338|NCT01945242|B2|Baseline|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
107339|NCT01945242|B1|Baseline|Alogliptin + Thiazolidinedione|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
107340|NCT01945242|P2|Participant Flow|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
107341|NCT01945242|P1|Participant Flow|Alogliptin + Thiazolidinedione|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
107342|NCT01945242|O1|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months.
107343|NCT01945242|O1|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months.
107344|NCT01945242|O1|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months.
107345|NCT01945242|O1|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months.
107346|NCT01945242|O2|Outcome|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
107347|NCT01945242|O1|Outcome|Alogliptin + Thiazolidinedione|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
107348|NCT01945242|O2|Outcome|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
107349|NCT01945242|O1|Outcome|Alogliptin + Thiazolidinedione|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
107350|NCT01945242|E2|Reported Event|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
107351|NCT01945242|E1|Reported Event|Alogliptin + Thiazolidinedione|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
107352|NCT01945138|B3|Baseline|Total|Total of all reporting groups
107353|NCT01945138|B2|Baseline|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
107354|NCT01945138|B1|Baseline|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
107413|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
107414|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
107355|NCT01945138|P2|Participant Flow|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
107356|NCT01945138|P1|Participant Flow|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
107357|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
107358|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
107359|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
107360|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
107361|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
107362|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
107363|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
107364|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
107365|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
107366|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
107367|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
107368|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
107369|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
107370|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
107371|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
107372|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
107373|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
107374|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
107375|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
107376|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
107377|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
108110|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
107379|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
107380|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
107381|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
107382|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
107383|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
107384|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
107385|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
107386|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
107387|NCT01945138|E2|Reported Event|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
107388|NCT01945138|E1|Reported Event|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
107389|NCT01945112|B1|Baseline|Paper Tape|Paper was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
107390|NCT01945112|P2|Participant Flow|Paper Tape on Left and No Tape on Right Foot|Paper tape was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
107391|NCT01945112|P1|Participant Flow|Paper Tape on Right and No Tape on Left Foot|Paper tape was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
107392|NCT01945112|O1|Outcome|Paper Tape|Paper tape was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
107393|NCT01945112|E2|Reported Event|Tape on Left Foot and No Tape on Right Foot|Paper tape was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
107394|NCT01945112|E1|Reported Event|Paper Tape on RIght Foot and No Tape on Left Foot|Paper tape was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
107395|NCT01945086|B4|Baseline|Total|Total of all reporting groups
107396|NCT01945086|B3|Baseline|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
107397|NCT01945086|B2|Baseline|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
107398|NCT01945086|B1|Baseline|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
107399|NCT01945086|P3|Participant Flow|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
107400|NCT01945086|P2|Participant Flow|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
107401|NCT01945086|P1|Participant Flow|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
107402|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
107403|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
107404|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
107405|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
107406|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
107407|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
107408|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
107409|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
107410|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
107411|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
107412|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
107415|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
107416|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
107417|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
107418|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
107419|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
107420|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
107421|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
107422|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
107423|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
107424|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
107425|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
107426|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
107427|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
107428|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
107429|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
107430|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
107431|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
107432|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
107433|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
107434|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
107435|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
107436|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
107437|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
107438|NCT01945086|E3|Reported Event|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
107439|NCT01945086|E2|Reported Event|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
107440|NCT01945086|E1|Reported Event|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
107441|NCT01945034|B4|Baseline|Total|Total of all reporting groups
107442|NCT01945034|B3|Baseline|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
107443|NCT01945034|B2|Baseline|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107444|NCT01945034|B1|Baseline|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107445|NCT01945034|P3|Participant Flow|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
107446|NCT01945034|P2|Participant Flow|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107447|NCT01945034|P1|Participant Flow|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107448|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
107449|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107450|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107451|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
107452|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107453|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107454|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
107455|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107456|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107457|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
107458|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107459|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107460|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
107461|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107462|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107463|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
107464|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107465|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107466|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
107467|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107468|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107469|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
107470|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107471|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107472|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
107473|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107474|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107475|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
107476|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107477|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107478|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
107479|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107552|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
107480|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107481|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
107482|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107483|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107484|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
107485|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107486|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107487|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
107488|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107489|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107490|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
107491|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107492|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107493|NCT01945034|E3|Reported Event|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
107494|NCT01945034|E2|Reported Event|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107495|NCT01945034|E1|Reported Event|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
107496|NCT01945021|B1|Baseline|Crizotinib|Single arm trial whereby all consented, enrolled, eligible patients receive crizotinib
107497|NCT01945021|P1|Participant Flow|Crizotinib|Single-arm trial whereby all consented, enrolled, eligible patients receive crizotinib
107498|NCT01945021|O1|Outcome|Crizotinib|Single-arm trial whereby all consented, enrolled, eligible patients receive crizotinib
107499|NCT01945021|O1|Outcome|Crizotinib|Single-arm trial whereby all consented, enrolled, eligible patients receive crizotinib
107500|NCT01945021|O1|Outcome|Safety Evaluable Population|The safety analysis population (SAF) included all enrolled patients who receive at least one dose of study medication. (n=127).
107501|NCT01945021|O1|Outcome|Safety Evaluable Population|The safety analysis population (SAF) will include all enrolled patients who receive at least one dose of study medication. (n=127).
107502|NCT01945021|O1|Outcome|Safety Evaluable Population|The safety analysis population (SAF) will include all enrolled patients who receive at least one dose of study medication. (n=127).
107503|NCT01945021|O1|Outcome|Safety Evaluable Population|The safety analysis population (SAF) will include all enrolled patients who receive at least one dose of study medication. (n=127).
107504|NCT01945021|O1|Outcome|Safety Evaluable Population|The safety analysis population (SAF) will include all enrolled patients who receive at least one dose of study medication. (n=127).
107505|NCT01945021|O1|Outcome|Response Evaluable Population|The response-evaluable population (RES) is defined as all patients in the safety analysis population who have an adequate baseline tumor assessment (n=127).
107506|NCT01945021|O1|Outcome|Participants With Objective Response by Independent Review|Defined as all patients in the safety analysis population who have an adequate baseline tumor assessment and an objective response determined by Independent Review (n=88).
107507|NCT01945021|O1|Outcome|Response Evaluable Population|The response-evaluable population (RES) is defined as all patients in the safety analysis population who have an adequate baseline tumor assessment (n=127).
107508|NCT01945021|O1|Outcome|Response Evaluable Population|The response-evaluable population (RES) is defined as all patients in the safety analysis population who have an adequate baseline tumor assessment (n=127).
107509|NCT01945021|E1|Reported Event|Crizotinib|Single-arm trial whereby all consented, enrolled, eligible patients receive crizotinib
107553|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
107510|NCT01944969|B1|Baseline|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
107511|NCT01944969|P1|Participant Flow|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
107512|NCT01944969|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
107513|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
107514|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
107515|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
107516|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1,2, or 3 mg/day, once daily dose, tablets, orally"
107517|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
107518|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
107519|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
107520|NCT01944969|E1|Reported Event|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
107521|NCT01944878|B3|Baseline|Total|Total of all reporting groups
107522|NCT01944878|B2|Baseline|Patients With Liver Cirrhosis|Patients with liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
107523|NCT01944878|B1|Baseline|Patients With Chronic Hepatitis|Patients with chronic hepatitis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
107524|NCT01944878|P2|Participant Flow|Patients With Liver Cirrhosis|Patients with liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
107525|NCT01944878|P1|Participant Flow|Patients With Chronic Hepatitis|Patients with chronic hepatitis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
107526|NCT01944878|O2|Outcome|No PUD in Lchronic Hepatitis|
107527|NCT01944878|O1|Outcome|PUD in Chronic Hepatitis|
107528|NCT01944878|O2|Outcome|No PUD in Liver Cirrhosis|Patients without PUD in liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
107529|NCT01944878|O1|Outcome|PUD in Liver Cirrhosis|Patients with PUD in liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
107530|NCT01944878|E2|Reported Event|Patients With Liver Cirrhosis|Patients with liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
107531|NCT01944878|E1|Reported Event|Patients With Chronic Hepatitis|Patients with chronic hepatitis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
107532|NCT01944774|B4|Baseline|Total|Total of all reporting groups
107533|NCT01944774|B3|Baseline|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
107534|NCT01944774|B2|Baseline|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
107535|NCT01944774|B1|Baseline|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
107536|NCT01944774|P3|Participant Flow|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
107537|NCT01944774|P2|Participant Flow|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
107538|NCT01944774|P1|Participant Flow|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
107539|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
107540|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
107541|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
107542|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
107543|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
107544|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
107545|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
107546|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
107547|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
107548|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
107549|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
107550|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
107551|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
107554|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
107555|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
107556|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
107557|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
107558|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
107559|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
107560|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
107561|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
107562|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
107563|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days
107564|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days
107565|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days
107566|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days
107567|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days
107568|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days
107569|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days
107570|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days
107571|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days
107572|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days
107573|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days
107574|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days
107575|NCT01944774|E3|Reported Event|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
107576|NCT01944774|E2|Reported Event|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
107577|NCT01944774|E1|Reported Event|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
107578|NCT01944722|B3|Baseline|Total|Total of all reporting groups
107579|NCT01944722|B2|Baseline|NILM Aged 30 Years and Older|Participants aged 30 years and older and having cytology results that are negative for intraepithelial lesions or malignancy (NILM).
107580|NCT01944722|B1|Baseline|ASCUS Aged 21 Years and Older|Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS).
107581|NCT01944722|P1|Participant Flow|BD Onclarity™ HPV Assay on BD Viper™ LT|"The LBC specimen will be tested with the BD Onclarity™ HPV assay on the BD Viper™ LT instrument. The results will be compared to adjudicated histology. A portion of the specimens will be compared to a composite comparator generated by results of both Digene (HC2) HPV and a polymerase chain reaction (PCR) sequencing test.~Colposcopy will be performed on subjects that have abnormal cytology or HPV positive test results or a random sampling of subjects with normal cytology and HPV negative test results."
107582|NCT01944722|O2|Outcome|NILM >= 30 Years Old|Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
107583|NCT01944722|O1|Outcome|ASCUS >= 21 Years Old|Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS).
107584|NCT01944722|O1|Outcome|BD Onclarity™ HPV Assay on BD Viper™ LT|"The LBC specimen will be tested with the BD Onclarity™ HPV assay on the BD Viper™ LT instrument.~The results will be compared to adjudicated histology. A portion of the specimens will be compared to a composite comparator generated by results of both Digene (HC2) HPV and a polymerase chain reaction (PCR) sequencing test.~Colposcopy will be performed on subjects that have abnormal cytology or HPV positive test results or a random sampling of subjects with normal cytology and HPV negative test results."
107585|NCT01944722|O2|Outcome|NILM >= 30 Years Old|Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
107586|NCT01944722|O1|Outcome|ASCUS >= 21 Years Old|Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS).
107587|NCT01944722|O2|Outcome|NILM >= 30 Years Old|Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
107588|NCT01944722|O1|Outcome|ASCUS >= 21 Years Old|Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS).
107589|NCT01944722|O2|Outcome|NILM >= 30 Years Old|Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
107590|NCT01944722|O1|Outcome|ASCUS >= 21 Years Old|Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS).
107591|NCT01944722|O2|Outcome|NILM >= 30 Years Old|Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
107592|NCT01944722|O1|Outcome|ASCUS >= 21 Years Old|Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS).
107593|NCT01944722|O2|Outcome|NILM >= 30 Years Old|Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
107594|NCT01944722|O1|Outcome|ASCUS >= 21 Years Old|Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS).
108111|NCT01941498|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
107595|NCT01944722|O2|Outcome|NILM >= 30 Years Old|Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
107596|NCT01944722|O1|Outcome|ASCUS >= 21 Years Old|Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS).
107597|NCT01944722|O2|Outcome|NILM >= 30 Years Old|Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
107598|NCT01944722|O1|Outcome|ASCUS >= 21 Years Old|Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS).
107599|NCT01944722|O2|Outcome|NILM >= 30 Years Old|Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
107600|NCT01944722|O1|Outcome|ASCUS >= 21 Years Old|Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS).
107601|NCT01944722|O2|Outcome|NILM >= 30 Years Old|Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
107602|NCT01944722|O1|Outcome|ASCUS >= 21 Years Old|Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS).
107603|NCT01944722|O2|Outcome|NILM >= 30 Years Old|Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
107604|NCT01944722|O1|Outcome|ASCUS >= 21 Years Old|Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS).
107605|NCT01944722|O2|Outcome|NILM >= 30 Years Old|Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
107606|NCT01944722|O1|Outcome|ASCUS >= 21 Years Old|Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS)
107607|NCT01944722|O2|Outcome|NILM >= 30 Years Old|Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
107608|NCT01944722|O1|Outcome|ASCUS >= 21 Years Old|Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS).
107609|NCT01944722|O2|Outcome|ASCUS >= 21 Years Old|Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS)
107610|NCT01944722|O1|Outcome|NILM >= 30 Years Old|Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
107611|NCT01944722|O2|Outcome|NILM >= 30 Years Old|Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
107612|NCT01944722|O1|Outcome|ASCUS >= 21 Years Old|Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS)
107613|NCT01944722|E1|Reported Event|BD HPV Onclarity™ Assay on BD Viper™ LT|Subjects tested with the BD HPV Onclarity™ assay on the BD Viper™ LT instrument.
107614|NCT01944670|B1|Baseline|Internal Joint Stabilizer Group|"Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E)~Internal Joint Stabilizer - Elbow (IJS-E): Device designed for internal stabilization of the elbow"
107615|NCT01944670|P1|Participant Flow|Internal Joint Stabilizer Group|"Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E)~Internal Joint Stabilizer - Elbow (IJS-E): Device designed for internal stabilization of the elbow"
107616|NCT01944670|O1|Outcome|Participants Who Completed the Study|"Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E) who completed the study (have final follow-up data)~Internal Joint Stabilizer - Elbow (IJS-E): Device designed for internal stabilization of the elbow"
107617|NCT01944670|O1|Outcome|Participants Who Completed the Study|"Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E) who completed the study (have final follow-up data)~Internal Joint Stabilizer - Elbow (IJS-E): Device designed for internal stabilization of the elbow"
107618|NCT01944670|E1|Reported Event|Participants Who Completed the Study|"Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E) who completed the study (have final follow-up data)~Internal Joint Stabilizer - Elbow (IJS-E): Device designed for internal stabilization of the elbow"
107619|NCT01944631|B3|Baseline|Total|Total of all reporting groups
107620|NCT01944631|B2|Baseline|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
107621|NCT01944631|B1|Baseline|Placebo|Patients received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
107622|NCT01944631|P2|Participant Flow|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
107623|NCT01944631|P1|Participant Flow|Placebo|Patients received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
107624|NCT01944631|O2|Outcome|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
107625|NCT01944631|O1|Outcome|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
107626|NCT01944631|O2|Outcome|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
107627|NCT01944631|O1|Outcome|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
107628|NCT01944631|O2|Outcome|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
107629|NCT01944631|O1|Outcome|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
107630|NCT01944631|O2|Outcome|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
107631|NCT01944631|O1|Outcome|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
107679|NCT01944098|E2|Reported Event|Placebo|"Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr~Placebo"
107632|NCT01944631|O2|Outcome|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
107633|NCT01944631|O1|Outcome|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
107634|NCT01944631|O2|Outcome|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
107635|NCT01944631|O1|Outcome|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
107636|NCT01944631|E2|Reported Event|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
107637|NCT01944631|E1|Reported Event|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
107638|NCT01944462|B1|Baseline|PPPP Participants|One group (pre/post design) receiving the PPPP intervention
107639|NCT01944462|P1|Participant Flow|PPPP Participants|One group (pre/post design) receiving the PPPP intervention
107640|NCT01944462|O1|Outcome|Pharmacy Staff|Pharmacy staff (pharmacy faculty and students) were surveyed after the completion of the program to determine their satisfaction with the program.
107641|NCT01944462|O1|Outcome|PPPP Participants|One group (pre/post design) receiving the PPPP intervention
107642|NCT01944462|O1|Outcome|PPPP Participants|One group (pre/post design) receiving the PPPP intervention
107643|NCT01944462|O1|Outcome|PPPP Participants|One group (pre/post design) receiving the PPPP intervention
107644|NCT01944462|O1|Outcome|PPPP Participants|One group (pre/post design) receiving the PPPP intervention
107645|NCT01944462|O1|Outcome|PPPP Participants|One group (pre/post design) receiving the PPPP intervention
107646|NCT01944462|E1|Reported Event|PPPP Participants - Vaccine Recipients|Subgroup of participants receiving the pneumococcal vaccine (Pneumococcal Vaccine Polyvalent (Pneumovax® 23))
107647|NCT01944345|B1|Baseline|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
107648|NCT01944345|P1|Participant Flow|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
107649|NCT01944345|O1|Outcome|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
107650|NCT01944345|O1|Outcome|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
107651|NCT01944345|O1|Outcome|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
107652|NCT01944345|E1|Reported Event|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
107653|NCT01944319|B3|Baseline|Total|Total of all reporting groups
107654|NCT01944319|B2|Baseline|Study Group|"Patients in Study group will accept meropenem therapy based on PPK and PD parameter.~Meropenem therapy based on PPK and PD: Meropenem therapy with regimen decided by a software developed from a PPK model and clinical PD parameter"
107655|NCT01944319|B1|Baseline|Control Group|Meropenem therapy with regimen routinely decided by attending physician
107656|NCT01944319|P2|Participant Flow|Study Group|"Patients in Study group will accept meropenem therapy based on PPK and PD parameter.~Meropenem therapy based on PPK and PD: Meropenem therapy with regimen decided by a software developed from a PPK model and clinical PD parameter"
107657|NCT01944319|P1|Participant Flow|Control Group|Meropenem therapy with regimen routinely decided by attending physician
107658|NCT01944319|O2|Outcome|Study Group|The participants in study group will accept meropenem therapy based on a PPK and PD model.
107659|NCT01944319|O1|Outcome|Control Group|The participants in control group will accept routine meropenem therapy.
107660|NCT01944319|O2|Outcome|Study Group|The participants in study group will accept meropenem therapy based on a PPK and PD model.
107661|NCT01944319|O1|Outcome|Control Group|The participants in control group will accept routine meropenem therapy.
107662|NCT01944319|O2|Outcome|Study Group|The participants in stusy group will accept meropenem therapy based on a PPK and PD model.
107663|NCT01944319|O1|Outcome|Control Group|The participants in control group will accept routine meropenem therapy.
107664|NCT01944319|E2|Reported Event|Study Group|The participants in study group will accept meropenem therapy based on a PPK and PD model.
107665|NCT01944319|E1|Reported Event|Control Group|The participants in control group will accept routine meropenem therapy.
107666|NCT01944098|B3|Baseline|Total|Total of all reporting groups
107667|NCT01944098|B2|Baseline|Placebo Arm|Patients received 2mg/kg/hr of placebo (saline) intraoperatively from the time of induction until the time of emergence.
107668|NCT01944098|B1|Baseline|Treatment Arm|Patients received 2mg/kg/hr of lidocaine intraoperatively from the time of induction until the time of emergence.
107669|NCT01944098|P2|Participant Flow|Placebo|"Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr~Placebo"
107670|NCT01944098|P1|Participant Flow|Lidocaine|"Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr~Lidocaine"
107671|NCT01944098|O2|Outcome|Placebo|"Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr~Placebo"
107672|NCT01944098|O1|Outcome|Lidocaine|"Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr~Lidocaine"
107673|NCT01944098|O2|Outcome|Placebo|"Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr~Placebo"
107674|NCT01944098|O1|Outcome|Lidocaine|"Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr~Lidocaine"
107675|NCT01944098|O2|Outcome|Placebo|"Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr~Placebo"
107676|NCT01944098|O1|Outcome|Lidocaine|"Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr~Lidocaine"
107677|NCT01944098|O2|Outcome|Placebo|"Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr~Placebo"
107678|NCT01944098|O1|Outcome|Lidocaine|"Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr~Lidocaine"
107680|NCT01944098|E1|Reported Event|Lidocaine|"Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr~Lidocaine"
107681|NCT01944059|B1|Baseline|All Participants|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors.~Placebo (l-alanine): Theramine like placebo comparator"
107682|NCT01944059|P1|Participant Flow|All Participants|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors.~Placebo (l-alanine): Theramine like placebo comparator"
107683|NCT01944059|O2|Outcome|Placebo (L-alanine)|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Placebo (l-alanine): Theramine like placebo comparator"
107684|NCT01944059|O1|Outcome|Theramine|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors."
107685|NCT01944059|O2|Outcome|Placebo (L-alanine)|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Placebo (l-alanine): Theramine like placebo comparator"
107686|NCT01944059|O1|Outcome|Theramine|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors."
107687|NCT01944059|O2|Outcome|Placebo (L-alanine)|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Placebo (l-alanine): Theramine like placebo comparator"
107688|NCT01944059|O1|Outcome|Theramine|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors."
107689|NCT01944059|E1|Reported Event|All Participants|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors.~Placebo (l-alanine): Theramine like placebo comparator"
107690|NCT01943864|B1|Baseline|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107691|NCT01943864|P1|Participant Flow|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107692|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107693|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107694|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107695|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107696|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107697|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107827|NCT01943344|E1|Reported Event|Treatment|"Subjects that receive VIVASURE CLOSURE DEVICE™~VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™"
107698|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107699|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107700|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107701|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107702|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107703|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107704|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107705|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107706|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107707|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107708|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107709|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107710|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107711|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107712|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107713|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107714|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107715|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107716|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107828|NCT01943292|B4|Baseline|Total|Total of all reporting groups
107717|NCT01943864|E1|Reported Event|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
107718|NCT01943565|B4|Baseline|Total|Total of all reporting groups
107719|NCT01943565|B3|Baseline|Hydromorphone 100mcg|"The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107720|NCT01943565|B2|Baseline|Hydromorphone 50mcg|"The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107721|NCT01943565|B1|Baseline|Hydromorphone 25mcg|"The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107722|NCT01943565|P3|Participant Flow|Hydromorphone 100mcg|"The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107723|NCT01943565|P2|Participant Flow|Hydromorphone 50mcg|"The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107724|NCT01943565|P1|Participant Flow|Hydromorphone 25mcg|"The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107725|NCT01943565|O3|Outcome|Hydromorphone 100mcg|"The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107726|NCT01943565|O2|Outcome|Hydromorphone 50mcg|"The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107727|NCT01943565|O1|Outcome|Hydromorphone 25mcg|"The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107728|NCT01943565|O3|Outcome|Hydromorphone 100mcg|"The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107729|NCT01943565|O2|Outcome|Hydromorphone 50mcg|"The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107730|NCT01943565|O1|Outcome|Hydromorphone 25mcg|"The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107731|NCT01943565|O3|Outcome|Hydromorphone 100mcg|"The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107732|NCT01943565|O2|Outcome|Hydromorphone 50mcg|"The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107733|NCT01943565|O1|Outcome|Hydromorphone 25mcg|"The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107734|NCT01943565|O3|Outcome|Hydromorphone 100mcg|"The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107735|NCT01943565|O2|Outcome|Hydromorphone 50mcg|"The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107736|NCT01943565|O1|Outcome|Hydromorphone 25mcg|"The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107737|NCT01943565|O3|Outcome|Hydromorphone 100mcg|"The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107738|NCT01943565|O2|Outcome|Hydromorphone 50mcg|"The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107739|NCT01943565|O1|Outcome|Hydromorphone 25mcg|"The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107740|NCT01943565|O3|Outcome|Hydromorphone 100mcg|"The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107741|NCT01943565|O2|Outcome|Hydromorphone 50mcg|"The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107742|NCT01943565|O1|Outcome|Hydromorphone 25mcg|"The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107743|NCT01943565|O3|Outcome|Hydromorphone 100mcg|"The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107744|NCT01943565|O2|Outcome|Hydromorphone 50mcg|"The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107745|NCT01943565|O1|Outcome|Hydromorphone 25mcg|"The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107829|NCT01943292|B3|Baseline|Defactinib 600 mg Bid|600 mg po bid defactinib
107746|NCT01943565|O3|Outcome|Hydromorphone 100mcg|"The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107747|NCT01943565|O2|Outcome|Hydromorphone 50mcg|"The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107748|NCT01943565|O1|Outcome|Hydromorphone 25mcg|"The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107749|NCT01943565|E3|Reported Event|Hydromorphone 100mcg|"The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107750|NCT01943565|E2|Reported Event|Hydromorphone 50mcg|"The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107751|NCT01943565|E1|Reported Event|Hydromorphone 25mcg|"The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia~Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg~spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
107752|NCT01943552|B3|Baseline|Total|Total of all reporting groups
107753|NCT01943552|B2|Baseline|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
107754|NCT01943552|B1|Baseline|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
107755|NCT01943552|P2|Participant Flow|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
107756|NCT01943552|P1|Participant Flow|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
107757|NCT01943552|O2|Outcome|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
107758|NCT01943552|O1|Outcome|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
107759|NCT01943552|O2|Outcome|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
107760|NCT01943552|O1|Outcome|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
107761|NCT01943552|O2|Outcome|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
107762|NCT01943552|O1|Outcome|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
107763|NCT01943552|O2|Outcome|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
107764|NCT01943552|O1|Outcome|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
107765|NCT01943552|O2|Outcome|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
107766|NCT01943552|O1|Outcome|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
107767|NCT01943552|O2|Outcome|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
107768|NCT01943552|O1|Outcome|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
107769|NCT01943552|E2|Reported Event|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
107770|NCT01943552|E1|Reported Event|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
107771|NCT01943539|B1|Baseline|EVO Game Play|"Neuro-typical controls and ADHD will receive EVO game play.~Neuro-typical controls and ADHD will receive EVO game play.: EVO mobile video application"
107772|NCT01943539|P2|Participant Flow|ADHD|Children diagnosed with ADHD and not on ADHD medication.
107773|NCT01943539|P1|Participant Flow|Neuro-typical Controls|Non-ADHD neuro-typical children
107774|NCT01943539|O2|Outcome|ADHD|Children diagnosed with ADHD and not taking ADHD medication
107775|NCT01943539|O1|Outcome|Neurotypical Controls|Non-ADHD neuro-typical children
107776|NCT01943539|O1|Outcome|EVO Game Play|"Neuro-typical controls and ADHD will receive EVO game play.~Neuro-typical controls and ADHD will receive EVO game play.: EVO mobile video application"
107777|NCT01943539|O1|Outcome|EVO Game Play|"Neuro-typical controls and ADHD will receive EVO game play.~Neuro-typical controls and ADHD will receive EVO game play.: EVO mobile video application"
107778|NCT01943539|O1|Outcome|EVO Game Play|"Neuro-typical controls and ADHD will receive EVO game play.~Neuro-typical controls and ADHD will receive EVO game play.: EVO mobile video application"
107779|NCT01943539|E2|Reported Event|ADHD|Children diagnosed with ADHD and no on ADHD medication
107780|NCT01943539|E1|Reported Event|Neurotypical Controls|Non-ADHD neurotypical children
107781|NCT01943474|B3|Baseline|Total|Total of all reporting groups
107782|NCT01943474|B2|Baseline|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.~Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
107783|NCT01943474|B1|Baseline|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
107830|NCT01943292|B2|Baseline|Defactinib 400 mg Bid|400 mg po bid defactinib
107831|NCT01943292|B1|Baseline|Defactinib 200 mg Bid|200 mg po bid defactinib
107832|NCT01943292|P3|Participant Flow|Defactinib 600 mg Bid|600 mg bid po defactinib
107784|NCT01943474|P2|Participant Flow|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.~Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
107785|NCT01943474|P1|Participant Flow|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
107786|NCT01943474|O2|Outcome|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.~Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
107787|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
107788|NCT01943474|O2|Outcome|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.~Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
107789|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
107790|NCT01943474|O2|Outcome|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.~Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
107791|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
107792|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
107793|NCT01943474|O2|Outcome|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.~Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
107794|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
107795|NCT01943474|O2|Outcome|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.~Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
107796|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
107797|NCT01943474|O2|Outcome|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.~Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
107798|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
107799|NCT01943474|O2|Outcome|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.~Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
107800|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
107801|NCT01943474|O2|Outcome|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.~Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
107802|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
107833|NCT01943292|P2|Participant Flow|Defactinib 400 mg Bid|400 mg bid po defactinib
107834|NCT01943292|P1|Participant Flow|Defactinib 200 mg Bid|200 mg bid (twice a day) po (by mouth) defactinib
107803|NCT01943474|E2|Reported Event|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.~Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
107804|NCT01943474|E1|Reported Event|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
107805|NCT01943435|B4|Baseline|Total|Total of all reporting groups
107806|NCT01943435|B3|Baseline|Manual Therapy and Exercise|"This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:~Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations~Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor."
107807|NCT01943435|B2|Baseline|Group Exercise|"Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.~Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers."
107808|NCT01943435|B1|Baseline|Usual Medical Care|"Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following: NSAIDs, Adjunctive analgesics, antidepressants.~Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient.~Lumbar epidural injection: these will be prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications.~NSAIDs; adjunctive analgesics; adjunctive anti-depressants: Physician will administer these medications based upon the individual needs of each patient.~Lumbar epidural injection: The attending physician may refer s"
107809|NCT01943435|P3|Participant Flow|Manual Therapy and Exercise|"This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:~Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations~Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor."
107810|NCT01943435|P2|Participant Flow|Group Exercise|"Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.~Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers."
107811|NCT01943435|P1|Participant Flow|Medical Care|"Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following:~NSAIDs, Adjunctive analgesics, antidepressants,~Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient."
107812|NCT01943435|O3|Outcome|Manual Therapy and Exercise|"This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:~Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations.~Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor."
107813|NCT01943435|O2|Outcome|Group Exercise|"Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.~Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers."
107835|NCT01943292|O3|Outcome|Defactinib 600 mg Bid|600 mg po bid defactinib
107836|NCT01943292|O2|Outcome|Defactinib 400 mg Bid|400 mg po bid defactinib
107837|NCT01943292|O1|Outcome|Defactinib 200 mg Bid|200 mg po bid defactinib
107838|NCT01943292|O3|Outcome|Defactinib 600 mg Bid|600 mg po bid defactinib
107814|NCT01943435|O1|Outcome|Medical Care|"Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following:~NSAIDs, Adjunctive analgesics, antidepressants,~Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient."
107815|NCT01943435|O3|Outcome|Manual Therapy and Exercise|"This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:~Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations.~Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor."
107816|NCT01943435|O2|Outcome|Group Exercise|"Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.~Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers."
107817|NCT01943435|O1|Outcome|Medical Care|"Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following:~NSAIDs, Adjunctive analgesics, antidepressants,~Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient."
107818|NCT01943435|O3|Outcome|Manual Therapy and Exercise|"This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:~Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations.~Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor."
107819|NCT01943435|O2|Outcome|Group Exercise|"Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.~Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers."
107820|NCT01943435|O1|Outcome|Medical Care|"Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following:~NSAIDs, Adjunctive analgesics, antidepressants,~Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient."
107821|NCT01943435|E3|Reported Event|Manual Therapy and Exercise|"This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:~Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations~Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor."
107822|NCT01943435|E2|Reported Event|Group Exercise|"Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.~Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers."
107823|NCT01943435|E1|Reported Event|Medical Care|"Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following: NSAIDs, Adjunctive analgesics, antidepressants.~Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient."
107824|NCT01943344|B1|Baseline|Treatment|"Subjects that receive VIVASURE CLOSURE DEVICE™~VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™"
107825|NCT01943344|P1|Participant Flow|Treatment|"Subjects that receive VIVASURE CLOSURE DEVICE™~VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™"
107826|NCT01943344|O1|Outcome|Treatment|"Subjects that receive VIVASURE CLOSURE DEVICE™~VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™"
107844|NCT01943110|B1|Baseline|Saline Injection With ID Adapters|"Each participant will receive six injections of 0.1 ml of sterile saline solution into the skin:~Upper deltoid with the side-load ID adapter~Upper deltoid with the AD ID adapter~Suprascapular (behind the shoulder) with the side-load ID adapter~Suprascapular with the AD ID adapter~Forearm with the side-load ID adapter~Forearm with the AD ID adapter~ID adapter (autodisable): Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin. Contains an autodisable feature to prevent reuse.~ID adapter (side load): Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin."
107845|NCT01943110|P1|Participant Flow|Saline Injection With ID Adapters|"Each participant will receive six injections of 0.1 ml of sterile saline solution into the skin:~Upper deltoid with the side-load ID adapter~Upper deltoid with the AD ID adapter~Suprascapular (behind the shoulder) with the side-load ID adapter~Suprascapular with the AD ID adapter~Forearm with the side-load ID adapter~Forearm with the AD ID adapter~ID adapter (autodisable): Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin. Contains an autodisable feature to prevent reuse.~ID adapter (side load): Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin."
107846|NCT01943110|O2|Outcome|SLA ID Adapter|Injections given with the side-load ID adapter
107847|NCT01943110|O1|Outcome|AD ID Adapter|Injections given with the autodisable ID adapter
107848|NCT01943110|O6|Outcome|SLA Suprascapular|Injections given with the side-load ID adapter in the suprascapular region
107849|NCT01943110|O5|Outcome|SLA Forearm|Injections given with the side-load ID adapter in the forearm
107850|NCT01943110|O4|Outcome|SLA Deltoid|Injections given with the side-load ID adapter in the deltoid region
107851|NCT01943110|O3|Outcome|ADID Suprascapular|Injections given with the autodisable ID adapter in the suprascapular region
107852|NCT01943110|O2|Outcome|ADID Forearm|Injections given with the autodisable ID adapter in the forearm
107853|NCT01943110|O1|Outcome|ADID Deltoid|Injections given with the autodisable ID adapter in the deltoid region
107854|NCT01943110|E6|Reported Event|SLA Suprascapular|Injections given with the side-load ID adapter in the suprascapular region
107855|NCT01943110|E5|Reported Event|SLA Forearm|Injections given with the side-load ID adapter in the forearm region
107856|NCT01943110|E4|Reported Event|SLA Deltoid|Injections given with the side-load ID adapter in the deltoid region
107857|NCT01943110|E3|Reported Event|ADID Suprascapular|Injections given with the autodisable ID adapter in the suprascapular region
107858|NCT01943110|E2|Reported Event|ADID Forearm|Injections given with the autodisable ID adapter in the forearm region
107859|NCT01943110|E1|Reported Event|ADID Deltoid|Injections given with the autodisable ID adapter in the deltoid region
107860|NCT01942785|B1|Baseline|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
107861|NCT01942785|P1|Participant Flow|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
107862|NCT01942785|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label commercially available Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily dose, tablets, for oral use"
107863|NCT01942785|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label commercially available Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily dose, tablets, for oral use"
107864|NCT01942785|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label commercially available Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) antidepressant treatment (ADT)~Brexpiprazole:2-3 mg/day, once daily dose, tablets, for oral use"
107865|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
107866|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
107867|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
107868|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
107869|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
107870|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
107871|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
107872|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
107873|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
107874|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
107875|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
107876|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
107877|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
107878|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
107879|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
107880|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
107881|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
107882|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
107883|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
107884|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
107885|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
107886|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
107887|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
107888|NCT01942785|E1|Reported Event|Brexpiprazole|Brexpiprazole adjunct to open-label commercially available Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily dose, tablets, for oral use
107889|NCT01942733|B1|Baseline|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107890|NCT01942733|P1|Participant Flow|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107891|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107892|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107893|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107894|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107895|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107896|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107897|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107898|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107899|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107900|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107901|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107902|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107903|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107904|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107905|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107906|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107907|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107908|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107909|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107910|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107911|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107912|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107913|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107914|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107915|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107916|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
107917|NCT01942733|E1|Reported Event|Brexpiprazole|The all-patients-treated set (APTS) comprises all patients who took at least one dose of brexpiprazole.
107918|NCT01942720|B1|Baseline|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
107919|NCT01942720|P1|Participant Flow|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
107920|NCT01942720|O1|Outcome|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
107921|NCT01942720|O1|Outcome|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
107922|NCT01942720|O1|Outcome|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
107923|NCT01942720|O1|Outcome|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
107924|NCT01942720|O1|Outcome|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
107925|NCT01942720|E1|Reported Event|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
107926|NCT01942707|B3|Baseline|Total|Total of all reporting groups
107927|NCT01942707|B2|Baseline|Keeping Scarpa`s Fascia|"Abdominoplasty in anchor-line keeping Scarpa`s Fascia.~Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups"
107928|NCT01942707|B1|Baseline|No Keeping Scarpa`s Fascia|"Abdominoplasty in anchor-line without keeping Scarpa`s Fascia.~Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups"
107929|NCT01942707|P2|Participant Flow|Anchor-line Abdominoplasty With Scarpa`s Fascia|Anchor-line abdominoplasty. In this group the Scarpa`s Fascia will be preserved.
107930|NCT01942707|P1|Participant Flow|Anchor-line Abdominoplasty Without Scarpa`s Fascia|Anchor-line abdominoplasty. The Scarpa`s Fascia will be removed in this group.
107931|NCT01942707|O2|Outcome|With Scarpa`s Fascia|"Abdominoplasty in anchor-line keeping Scarpa`s Fascia.~Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups"
107932|NCT01942707|O1|Outcome|Without Scarpa`s Fascia|"Abdominoplasty in anchor-line without keeping Scarpa`s Fascia.~Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups"
107933|NCT01942707|O2|Outcome|With Scarpa`s Fascia|"Abdominoplasty in anchor-line keeping Scarpa`s Fascia.~Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups"
107934|NCT01942707|O1|Outcome|Without Scarpa`s Fascia|"Abdominoplasty in anchor-line without keeping Scarpa`s Fascia.~Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups"
107935|NCT01942707|O2|Outcome|With Scarpa`s Fascia|"Abdominoplasty in anchor-line keeping Scarpa`s Fascia.~Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups"
107936|NCT01942707|O1|Outcome|Without Scarpa`s Fascia|"Abdominoplasty in anchor-line without keeping Scarpa`s Fascia.~Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups"
107937|NCT01942707|E2|Reported Event|Anchor-line Abdominoplasty With Scarpa`s Fascia|Anchor-line abdominoplasty where the Scarpa´s Fascia will be preserved.
107938|NCT01942707|E1|Reported Event|Anchor-line Abdominoplasty Without Scarpa`s Fascia|Anchor-line Abdominoplasty where the Scarpa`s Fascia will be removed.
107939|NCT01942590|B3|Baseline|Total|Total of all reporting groups
107940|NCT01942590|B2|Baseline|Placebo Comparator|"Initially, one capsule (placebo) each morning for one week. Then, increase to one capsule BID for the next 5 weeks. If tolerated, will increase to two capsules in the morning and one capsule in the evening for one week. Then, last dose increase to two capsules until week 52.~Placebo"
107941|NCT01942590|B1|Baseline|Clenbuterol|"Initially, one capsule (40 mcg) each morning for one week. Then, increase to 40 mcg BID for the next 5 weeks. If tolerated, will increase to 80 mcg in the morning and 40 mcg in the evening for one week. Then, last dose increase will be 80 mcg BID until week 52.~Clenbuterol"
107942|NCT01942590|P2|Participant Flow|Placebo Comparator|"Initially, one capsule (placebo) each morning for one week. Then, increase to one capsule BID for the next 5 weeks. If tolerated, will increase to two capsules in the morning and one capsule in the evening for one week. Then, last dose increase to two capsules until week 52.~Placebo"
107943|NCT01942590|P1|Participant Flow|Clenbuterol|"Initially, 40 mcg each morning for one week. Then, increase to 40 mcg BID for the next 5 weeks. If tolerated, will increase to 80 mcg in the morning and 40 mcg in the evening for one week. Then, last dose increase will be 80 mcg BID until week 52.~Clenbuterol"
107944|NCT01942590|O2|Outcome|Placebo Comparator|"Initially, one capsule (placebo) each morning for one week. Then, increase to one capsule BID for the next 5 weeks. If tolerated, will increase to two capsules in the morning and one capsule in the evening for one week. Then, last dose increase to two capsules until week 52.~Placebo"
107945|NCT01942590|O1|Outcome|Clenbuterol|"Initially, one capsule (40 mcg) each morning for one week. Then, increase to 40 mcg BID for the next 5 weeks. If tolerated, will increase to 80 mcg in the morning and 40 mcg in the evening for one week. Then, last dose increase will be 80 mcg BID until week 52.~Clenbuterol"
108112|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
108113|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
108114|NCT01941498|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
107946|NCT01942590|O2|Outcome|Placebo Comparator|"Initially, one capsule (placebo) each morning for one week. Then, increase to one capsule BID for the next 5 weeks. If tolerated, will increase to two capsules in the morning and one capsule in the evening for one week. Then, last dose increase to two capsules until week 52.~Placebo"
107947|NCT01942590|O1|Outcome|Clenbuterol|"Initially, one capsule (40 mcg) each morning for one week. Then, increase to 40 mcg BID for the next 5 weeks. If tolerated, will increase to 80 mcg in the morning and 40 mcg in the evening for one week. Then, last dose increase will be 80 mcg BID until week 52.~Clenbuterol"
107948|NCT01942590|O2|Outcome|Placebo Comparator|"Initially, one capsule (placebo) each morning for one week. Then, increase to one capsule BID for the next 5 weeks. If tolerated, will increase to two capsules in the morning and one capsule in the evening for one week. Then, last dose increase to two capsules until week 52.~Placebo"
107949|NCT01942590|O1|Outcome|Clenbuterol|"Initially, one capsule (40 mcg) each morning for one week. Then, increase to 40 mcg BID for the next 5 weeks. If tolerated, will increase to 80 mcg in the morning and 40 mcg in the evening for one week. Then, last dose increase will be 80 mcg BID until week 52.~Clenbuterol"
107950|NCT01942590|O2|Outcome|Placebo Comparator|"Initially, one capsule (placebo) each morning for one week. Then, increase to one capsule BID for the next 5 weeks. If tolerated, will increase to two capsules in the morning and one capsule in the evening for one week. Then, last dose increase to two capsules until week 52.~Placebo"
107951|NCT01942590|O1|Outcome|Clenbuterol|"Initially, 40 mcg each morning for one week. Then, increase to 40 mcg BID for the next 5 weeks. If tolerated, will increase to 80 mcg in the morning and 40 mcg in the evening for one week. Then, last dose increase will be 80 mcg BID until week 52.~Clenbuterol"
107952|NCT01942590|O2|Outcome|Placebo Comparator|"Initially, one capsule (placebo) each morning for one week. Then, increase to one capsule BID for the next 5 weeks. If tolerated, will increase to two capsules in the morning and one capsule in the evening for one week. Then, last dose increase to two capsules until week 52.~Placebo"
107953|NCT01942590|O1|Outcome|Clenbuterol|"Initially, 40 mcg each morning for one week. Then, increase to 40 mcg BID for the next 5 weeks. If tolerated, will increase to 80 mcg in the morning and 40 mcg in the evening for one week. Then, last dose increase will be 80 mcg BID until week 52.~Clenbuterol"
107954|NCT01942590|O2|Outcome|Placebo Comparator|"Initially, one capsule (placebo) each morning for one week. Then, increase to one capsule BID for the next 5 weeks. If tolerated, will increase to two capsules in the morning and one capsule in the evening for one week. Then, last dose increase to two capsules until week 52.~Placebo"
107955|NCT01942590|O1|Outcome|Clenbuterol|"Initially, one capsule (40 mcg) each morning for one week. Then, increase to 40 mcg BID for the next 5 weeks. If tolerated, will increase to 80 mcg in the morning and 40 mcg in the evening for one week. Then, last dose increase will be 80 mcg BID until week 52.~Clenbuterol"
107956|NCT01942590|O2|Outcome|Placebo Comparator|"Initially, one capsule (placebo) each morning for one week. Then, increase to one capsule BID for the next 5 weeks. If tolerated, will increase to two capsules in the morning and one capsule in the evening for one week. Then, last dose increase to two capsules until week 52.~Placebo"
107957|NCT01942590|O1|Outcome|Clenbuterol|"Initially, one capsule (40 mcg) each morning for one week. Then, increase to 40 mcg BID for the next 5 weeks. If tolerated, will increase to 80 mcg in the morning and 40 mcg in the evening for one week. Then, last dose increase will be 80 mcg BID until week 52.~Clenbuterol"
107958|NCT01942590|O2|Outcome|Placebo Comparator|"Initially, one capsule (placebo) each morning for one week. Then, increase to one capsule BID for the next 5 weeks. If tolerated, will increase to two capsules in the morning and one capsule in the evening for one week. Then, last dose increase to two capsules until week 52.~Placebo"
107959|NCT01942590|O1|Outcome|Clenbuterol|"Initially, one capsule (40 mcg) each morning for one week. Then, increase to 40 mcg BID for the next 5 weeks. If tolerated, will increase to 80 mcg in the morning and 40 mcg in the evening for one week. Then, last dose increase will be 80 mcg BID until week 52.~Clenbuterol"
107960|NCT01942590|O2|Outcome|Placebo Comparator|"Initially, one capsule (placebo) each morning for one week. Then, increase to one capsule BID for the next 5 weeks. If tolerated, will increase to two capsules in the morning and one capsule in the evening for one week. Then, last dose increase to two capsules until week 52.~Placebo"
107961|NCT01942590|O1|Outcome|Clenbuterol|"Initially, one capsule (40 mcg) each morning for one week. Then, increase to 40 mcg BID for the next 5 weeks. If tolerated, will increase to 80 mcg in the morning and 40 mcg in the evening for one week. Then, last dose increase will be 80 mcg BID until week 52.~Clenbuterol"
107962|NCT01942590|O2|Outcome|Placebo Comparator|"Initially, one capsule (placebo) each morning for one week. Then, increase to one capsule BID for the next 5 weeks. If tolerated, will increase to two capsules in the morning and one capsule in the evening for one week. Then, last dose increase to two capsules until week 52.~Placebo"
107963|NCT01942590|O1|Outcome|Clenbuterol|"Initially, one capsule (40 mcg) each morning for one week. Then, increase to 40 mcg BID for the next 5 weeks. If tolerated, will increase to 80 mcg in the morning and 40 mcg in the evening for one week. Then, last dose increase will be 80 mcg BID until week 52.~Clenbuterol"
107964|NCT01942590|O2|Outcome|Placebo Comparator|"Initially, one capsule (placebo) each morning for one week. Then, increase to one capsule BID for the next 5 weeks. If tolerated, will increase to two capsules in the morning and one capsule in the evening for one week. Then, last dose increase to two capsules until week 52.~Placebo"
107965|NCT01942590|O1|Outcome|Clenbuterol|"Initially, one capsule (40 mcg) each morning for one week. Then, increase to 40 mcg BID for the next 5 weeks. If tolerated, will increase to 80 mcg in the morning and 40 mcg in the evening for one week. Then, last dose increase will be 80 mcg BID until week 52.~Clenbuterol"
107966|NCT01942590|O2|Outcome|Placebo Comparator|"Initially, one capsule (placebo) each morning for one week. Then, increase to one capsule BID for the next 5 weeks. If tolerated, will increase to two capsules in the morning and one capsule in the evening for one week. Then, last dose increase to two capsules until week 52.~Placebo"
107967|NCT01942590|O1|Outcome|Clenbuterol|"Initially, 40 mcg each morning for one week. Then, increase to 40 mcg BID for the next 5 weeks. If tolerated, will increase to 80 mcg in the morning and 40 mcg in the evening for one week. Then, last dose increase will be 80 mcg BID until week 52.~Clenbuterol"
107968|NCT01942590|O2|Outcome|Placebo Comparator|"Initially, one capsule (placebo) each morning for one week. Then, increase to one capsule BID for the next 5 weeks. If tolerated, will increase to two capsules in the morning and one capsule in the evening for one week. Then, last dose increase to two capsules until week 52.~Placebo"
107969|NCT01942590|O1|Outcome|Clenbuterol|"Initially, 40 mcg each morning for one week. Then, increase to 40 mcg BID for the next 5 weeks. If tolerated, will increase to 80 mcg in the morning and 40 mcg in the evening for one week. Then, last dose increase will be 80 mcg BID until week 52.~Clenbuterol"
107970|NCT01942590|E2|Reported Event|Placebo Comparator|"Initially, one capsule (placebo) each morning for one week. Then, increase to one capsule BID for the next 5 weeks. If tolerated, will increase to two capsules in the morning and one capsule in the evening for one week. Then, last dose increase to two capsules until week 52.~Placebo"
107971|NCT01942590|E1|Reported Event|Clenbuterol|"Initially, one capsule (40 mcg) each morning for one week. Then, increase to 40 mcg BID for the next 5 weeks. If tolerated, will increase to 80 mcg in the morning and 40 mcg in the evening for one week. Then, last dose increase will be 80 mcg BID until week 52.~Clenbuterol"
107972|NCT01942161|B4|Baseline|Total|Total of all reporting groups
107973|NCT01942161|B3|Baseline|High (24 - 30 mg/Day)|"Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below.~Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg"
107974|NCT01942161|B2|Baseline|Mid (6 - 12 mg/Day)|"Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below.~Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg"
107975|NCT01942161|B1|Baseline|Low (2 mg/Day)|"Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).~Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks"
107976|NCT01942161|P3|Participant Flow|High (24 - 30 mg/Day)|"Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below.~Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg"
107977|NCT01942161|P2|Participant Flow|Mid (6 - 12 mg/Day)|"Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below.~Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg"
107978|NCT01942161|P1|Participant Flow|Low (2 mg/Day)|"Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).~Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks"
107979|NCT01942161|O3|Outcome|High (24 - 30 mg/Day)|"Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below.~Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg"
107980|NCT01942161|O2|Outcome|Mid (6 - 12 mg/Day)|"Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below.~Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg"
107981|NCT01942161|O1|Outcome|Low (2 mg/Day)|"Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).~Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks"
107982|NCT01942161|O3|Outcome|High (24 - 30 mg/Day)|"Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below.~Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg"
107983|NCT01942161|O2|Outcome|Mid (6 - 12 mg/Day)|"Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below.~Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg"
107984|NCT01942161|O1|Outcome|Low (2 mg/Day)|"Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).~Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks"
107985|NCT01942161|O3|Outcome|High (24 - 30 mg/Day)|"Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below.~Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg"
107986|NCT01942161|O2|Outcome|Mid (6 - 12 mg/Day)|"Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below.~Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg"
107987|NCT01942161|O1|Outcome|Low (2 mg/Day)|"Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).~Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks"
108115|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
108116|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
108117|NCT01941498|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
107988|NCT01942161|O3|Outcome|High (24 - 30 mg/Day)|"Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below.~Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg"
107989|NCT01942161|O2|Outcome|Mid (6 - 12 mg/Day)|"Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below.~Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg"
107990|NCT01942161|O1|Outcome|Low (2 mg/Day)|"Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).~Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks"
107991|NCT01942161|O3|Outcome|High (24 - 30 mg/Day)|"Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below.~Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg"
107992|NCT01942161|O2|Outcome|Mid (6 - 12 mg/Day)|"Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below.~Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg"
107993|NCT01942161|O1|Outcome|Low (2 mg/Day)|"Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).~Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks"
107994|NCT01942161|E3|Reported Event|High (24 - 30 mg/Day)|"Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below.~Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg"
107995|NCT01942161|E2|Reported Event|Mid (6 - 12 mg/Day)|"Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below.~Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg"
107996|NCT01942161|E1|Reported Event|Low (2 mg/Day)|"Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).~Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks"
107997|NCT01942148|B1|Baseline|Aripiprazole|Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study.
107998|NCT01942148|P1|Participant Flow|Aripiprazole|Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study.
107999|NCT01942148|O1|Outcome|Aripiprazole|Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study.
108000|NCT01942148|O1|Outcome|Aripiprazole|Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study.
108001|NCT01942148|O1|Outcome|Aripiprazole|Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study.
108002|NCT01942148|E1|Reported Event|Aripiprazole|Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study.
108003|NCT01942135|B3|Baseline|Total|Total of all reporting groups
108004|NCT01942135|B2|Baseline|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108005|NCT01942135|B1|Baseline|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108006|NCT01942135|P2|Participant Flow|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108007|NCT01942135|P1|Participant Flow|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108118|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
108008|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108009|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108010|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108011|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108012|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108013|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108014|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108015|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108016|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108017|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108018|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108019|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108020|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108119|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
108120|NCT01941498|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
108021|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108022|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108023|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108024|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108025|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108026|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108027|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108028|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108029|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108030|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108031|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108032|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108033|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108121|NCT01941498|O2|Outcome|FS200 Laser|Femtosecond FS200 laser used during LASIK surgery for corneal ablation
108122|NCT01941498|O1|Outcome|EX500 Laser|Excimer 500 laser used during LASIK surgery for corneal ablation
108034|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108035|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108036|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108037|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108038|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108039|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108040|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108041|NCT01942135|E2|Reported Event|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108042|NCT01942135|E1|Reported Event|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
108043|NCT01941940|B1|Baseline|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108044|NCT01941940|P1|Participant Flow|Tocilizumab|Tocilizumab at a fixed dose of 162 milligrams (mg) was administered as subcutaneous (SC) injection alone or along with methotrexate and/or other non-biological Disease-Modifying Antirheumatic Drugs (DMARDs) irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108045|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108046|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108047|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108048|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108049|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108050|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108051|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108052|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108053|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108054|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108055|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108056|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108057|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108058|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108059|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108060|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108061|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108062|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108063|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108123|NCT01941498|O4|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
108064|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108065|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108066|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108067|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108068|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108069|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108070|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108071|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108072|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108073|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108074|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108075|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108076|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108077|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108078|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108079|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108124|NCT01941498|O3|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
108080|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108081|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108082|NCT01941940|E1|Reported Event|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
108083|NCT01941615|B1|Baseline|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
108084|NCT01941615|P1|Participant Flow|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
108085|NCT01941615|O1|Outcome|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
108086|NCT01941615|O1|Outcome|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
108087|NCT01941615|O1|Outcome|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
108088|NCT01941615|O1|Outcome|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
108089|NCT01941615|O1|Outcome|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
108090|NCT01941615|O1|Outcome|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
108091|NCT01941615|E1|Reported Event|Deleobuvir + Faldaprevir + Microgynon|"In the run-in period starting between Day -56 and Day -28, all subjects were to take 1 Microgynon® tablet (combined oral contraceptive ethinylestradiol / levonorgestrel) once daily for 21 to 49 days (depending on the menstrual cycle) until Day -8.~In the last 7 days of the run-in period (Day -7 to Day -1), no treatment was given in order to induce withdrawal bleeding. The next day was to be Day 1 of the study. Subjects who were using oral contraceptives before the study started the run-in period after the usual tablet-free interval of 7 days.~Subjects who were using hormonal contraceptive vaginal rings before the study started the run-in-period after the usual hormone-free interval of 7 days."
108092|NCT01941498|B1|Baseline|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
108093|NCT01941498|P1|Participant Flow|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
108094|NCT01941498|O4|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
108095|NCT01941498|O3|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
108096|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
108097|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
108098|NCT01941498|O2|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
108099|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
108100|NCT01941498|O5|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
108101|NCT01941498|O4|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
108125|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
108126|NCT01941498|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
108127|NCT01941498|O5|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
108128|NCT01941498|O4|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
108129|NCT01941498|O3|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
108130|NCT01941498|O2|Outcome|Day 1 Postoperative|WaveLight Refractive Suite
108131|NCT01941498|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
108132|NCT01941498|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
108133|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
108134|NCT01941498|O1|Outcome|Operation/Surgery (Day 1)|WaveLight Refractive Suite
108135|NCT01941498|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
108136|NCT01941498|E2|Reported Event|Screen Failure|Prior to treatment
108137|NCT01941498|E1|Reported Event|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers (Wavelight® Refractive Suite) used during LASIK surgery for corneal flap creation and corneal ablation
108138|NCT01941485|B1|Baseline|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
108139|NCT01941485|P1|Participant Flow|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
108140|NCT01941485|O1|Outcome|Angles|WaveLight Refractive Suite
108141|NCT01941485|O1|Outcome|AC Depth|WaveLight Refractive Suite
108142|NCT01941485|O1|Outcome|AC Volume|WaveLight Refractive Suite
108143|NCT01941485|O1|Outcome|Q-Value|WaveLight Refractive Suite
108144|NCT01941485|O1|Outcome|FS200 Laser|Femtosecond FS200 laser used during LASIK surgery for corneal flap creation
108145|NCT01941485|O5|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
108146|NCT01941485|O4|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
108147|NCT01941485|O3|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
108148|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
108149|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
108150|NCT01941485|O4|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
108151|NCT01941485|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
108152|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
108153|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
108154|NCT01941485|O4|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
108155|NCT01941485|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
108156|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
108157|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
108158|NCT01941485|O4|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
108159|NCT01941485|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
108160|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
108161|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
108162|NCT01941485|O4|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
108163|NCT01941485|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
108164|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
108165|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
108166|NCT01941485|O4|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
108167|NCT01941485|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
108168|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
108169|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
108170|NCT01941485|O4|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
108171|NCT01941485|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
108172|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
108173|NCT01941485|O1|Outcome|Operation/Surgery (Day 1)|WaveLight Refractive Suite
108174|NCT01941485|O6|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
108175|NCT01941485|O5|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
108176|NCT01941485|O4|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
108177|NCT01941485|O3|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
108178|NCT01941485|O2|Outcome|Day 1 Postoperative|WaveLight Refractive Suite
108179|NCT01941485|O1|Outcome|Operation/Surgery (Day 1)|WaveLight Refractive Suite
108180|NCT01941485|O5|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
108181|NCT01941485|O4|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
108182|NCT01941485|O3|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
108183|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
108184|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
108185|NCT01941485|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
108186|NCT01941485|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
108187|NCT01941485|O6|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
108188|NCT01941485|O5|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
108189|NCT01941485|O4|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
108190|NCT01941485|O3|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
108191|NCT01941485|O2|Outcome|Day 1 Postoperative|WaveLight Refractive Suite
108192|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
108193|NCT01941485|O6|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
108194|NCT01941485|O5|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
108195|NCT01941485|O4|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
108196|NCT01941485|O3|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
108197|NCT01941485|O2|Outcome|Day 1 Postoperative|WaveLight Refractive Suite
108198|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
108199|NCT01941485|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
108200|NCT01941485|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
108201|NCT01941485|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
108202|NCT01941485|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
108203|NCT01941485|E1|Reported Event|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
108204|NCT01941472|B1|Baseline|Septic Shock|Adult patients (at least 18 years of age) with refractory hypotension secondary to sepsis who, at the discretion of treating physicians, required fluid challenge in the presence of invasive hemodynamic monitoring. Refractory hypotension was defined as need of vasopressors to maintain systolic blood pressure (SBP) no less than 90 mmHg despite adequate fluid resuscitation.
108205|NCT01941472|P1|Participant Flow|Septic Shock|Adult patients (at least 18 years of age) with refractory hypotension secondary to sepsis who, at the discretion of treating physicians, required fluid challenge in the presence of invasive hemodynamic monitoring. Refractory hypotension was defined as need of vasopressors to maintain systolic blood pressure (SBP) no less than 90 mmHg despite adequate fluid resuscitation.
108206|NCT01941472|O1|Outcome|Septic Shock|Adult patients (at least 18 years of age) with refractory hypotension secondary to sepsis who, at the discretion of treating physicians, required fluid challenge in the presence of invasive hemodynamic monitoring. Refractory hypotension was defined as need of vasopressors to maintain systolic blood pressure (SBP) no less than 90 mmHg despite adequate fluid resuscitation.
108207|NCT01941472|E1|Reported Event|Septic Shock|Adult patients (at least 18 years of age) with refractory hypotension secondary to sepsis who, at the discretion of treating physicians, required fluid challenge in the presence of invasive hemodynamic monitoring. Refractory hypotension was defined as need of vasopressors to maintain systolic blood pressure (SBP) no less than 90 mmHg despite adequate fluid resuscitation.
108208|NCT01941186|B3|Baseline|Total|Total of all reporting groups
108209|NCT01941186|B2|Baseline|Routine Care|After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
108210|NCT01941186|B1|Baseline|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
108211|NCT01941186|P2|Participant Flow|Routine Care|After screening positive for a potential development delay those in the control received routine care, in this case, a handout explaining Early Intervention services.
108212|NCT01941186|P1|Participant Flow|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
108213|NCT01941186|O2|Outcome|Routine Care|After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
108214|NCT01941186|O1|Outcome|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
108215|NCT01941186|O2|Outcome|Routine Care|After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
108216|NCT01941186|O1|Outcome|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
108217|NCT01941186|O2|Outcome|Routine Care|After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
108218|NCT01941186|O1|Outcome|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
108219|NCT01941186|O2|Outcome|Routine Care|After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
108220|NCT01941186|O1|Outcome|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
108221|NCT01941186|O12|Outcome|Routine Care: Strongly Agree|"Percentage of parents who answered strongly agree to questions during pre and post intervention"
108222|NCT01941186|O11|Outcome|Routine Care: Agree|"Percentage of parents who answered agree to questions during pre and post intervention"
108223|NCT01941186|O10|Outcome|Routine Care: Somewhat Agree|"Percentage of parents who answered somewhat agree to questions during pre and post intervention."
108224|NCT01941186|O9|Outcome|Routine Care: Somewhat Disagree|"Percentage of parents who answered somewhat disagree to questions during pre and post intervention"
108225|NCT01941186|O8|Outcome|Routine Care: Disagree|"Percentage of parents who answered disagree to questions during pre and post intervention"
108226|NCT01941186|O7|Outcome|Routine Care: Strongly Disagree|"Percentage of parents who answered strongly disagree to questions during pre and post intervention"
108227|NCT01941186|O6|Outcome|Patient Decision Aid: Strongly Agree|"Percentage of parents who answered Strongly Agree to questions during pre and post intervention"
108228|NCT01941186|O5|Outcome|Patient Decision Aid: Agree|"Percentage of parents who answered agree to questions during pre and post intervention"
108229|NCT01941186|O4|Outcome|Patient Decision Aid: Somewhat Agree|"Percentage of parents who answered somewhat agree to questions during pre and post intervention"
108230|NCT01941186|O3|Outcome|Patient Decision Aid: Somewhat Disagree|"Percentage of parents who answered somewhat disagree to questions during pre and post"
108231|NCT01941186|O2|Outcome|Patient Decision Aid: Disagree|"Percentage of parents who answered disagree to questions during pre and post intervention"
108232|NCT01941186|O1|Outcome|Patient Decision Aid: Strongly Disagree|"Percentage of parents who answered strongly disagree to questions during pre and post intervention"
108233|NCT01941186|O2|Outcome|Routine Care|After screening positive for a potential development delay those in the control received routine care, in this case, a handout explaining Early Intervention services.
108234|NCT01941186|O1|Outcome|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
108235|NCT01941186|E2|Reported Event|Routine Care|After screening positive for a potential development delay those in the control received routine care, in this case, a handout explaining Early Intervention services.
108236|NCT01941186|E1|Reported Event|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
108237|NCT01940523|B3|Baseline|Total|Total of all reporting groups
108238|NCT01940523|B2|Baseline|Intravenous Tranexamic Acid|"1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.~Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure."
108239|NCT01940523|B1|Baseline|Topical Tranexamic Acid|"3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).~Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes."
108240|NCT01940523|P2|Participant Flow|Intravenous Tranexamic Acid|"1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.~Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure."
108241|NCT01940523|P1|Participant Flow|Topical Tranexamic Acid|"3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes. The surgeon will suction away excess solution. The site may be irrigated before or after the tranexamic acid bath as long as the solution is in contact for at least five full minutes. Tourniquet will be released.~Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m)."
108242|NCT01940523|O2|Outcome|Intravenous Tranexamic Acid|"1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.~Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure."
108256|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
108356|NCT01940471|E2|Reported Event|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108243|NCT01940523|O1|Outcome|Topical Tranexamic Acid|"3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).~Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes."
108244|NCT01940523|O2|Outcome|Intravenous Tranexamic Acid|"1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.~Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure."
108245|NCT01940523|O1|Outcome|Topical Tranexamic Acid|"3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).~Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes."
108246|NCT01940523|E2|Reported Event|Intravenous Tranexamic Acid|"1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.~Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure."
108247|NCT01940523|E1|Reported Event|Topical Tranexamic Acid|"3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).~Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes."
108248|NCT01940510|B1|Baseline|Whole Study: Alectinib + Rifampin|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 16), and Period 3 (Days 17 to 21). Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally alone on Day 1 (Period 1), with rifampin (600 mg capsules orally) on Day 17 (Period 3), and rifampin alone was administered from Days 8 through 16 (Period 2) and from Days 18 through 20 (Period 3).
108249|NCT01940510|P1|Participant Flow|Whole Study: Alectinib + Rifampin|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 16), and Period 3 (Days 17 to 21). Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib (RO5424802) 600 milligram (mg) capsules (four 150 mg capsules) orally alone on Day 1 (Period 1), with rifampin (600 mg capsules [two 300 mg capsules] orally) on Day 17 (Period 3), and rifampin alone was administered from Days 8 through 16 (Period 2) and from Days 18 through 20 (Period 3).
108250|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
108251|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
108252|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
108253|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
108254|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
108255|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
108257|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
109668|NCT01937364|O1|Outcome|Placebo|Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.
108258|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
108259|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
108260|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
108261|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
108262|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
108263|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
108264|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
108265|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
108266|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
108267|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
108268|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
108269|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
108270|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
108271|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
108272|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
108273|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
108274|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
108275|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
108354|NCT01940471|O2|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks per amendment 1 & 2) or 144 weeks (per amendment 3)
108276|NCT01940510|E3|Reported Event|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
108277|NCT01940510|E2|Reported Event|Treatment Period 2: Rifampin|Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 8 through 16.
108278|NCT01940510|E1|Reported Event|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
108279|NCT01940497|B3|Baseline|Total|Total of all reporting groups
108280|NCT01940497|B2|Baseline|Trastuzumab (SID)|Participants received trastuzumab 600 mg subcutaneously using single-use injection device (SID) every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108281|NCT01940497|B1|Baseline|Trastuzumab (Vial)|Participants received trastuzumab 600 milligrams (mg) subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108282|NCT01940497|P2|Participant Flow|Trastuzumab (SID)|Participants received trastuzumab 600 mg subcutaneously using single-use injection device (SID) every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108283|NCT01940497|P1|Participant Flow|Trastuzumab (Vial)|Participants received trastuzumab 600 milligrams (mg) subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108284|NCT01940497|O2|Outcome|HCPs: Trastuzumab (SID)|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone). Trastuzumab using SID had to be administered by an HCP or by the participant after appropriate training and under HCP supervision.
108285|NCT01940497|O1|Outcome|HCPs: Trastuzumab (Vial)|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone). Trastuzumab using vial had to be administered by an HCP.
108286|NCT01940497|O1|Outcome|Trastuzumab (SID)|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108287|NCT01940497|O4|Outcome|Trastuzumab (SID): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108288|NCT01940497|O3|Outcome|Trastuzumab (SID): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108289|NCT01940497|O2|Outcome|Trastuzumab (Vial): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108290|NCT01940497|O1|Outcome|Trastuzumab (Vial): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108291|NCT01940497|O4|Outcome|Trastuzumab (SID): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108292|NCT01940497|O3|Outcome|Trastuzumab (SID): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108293|NCT01940497|O2|Outcome|Trastuzumab (Vial): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108294|NCT01940497|O1|Outcome|Trastuzumab (Vial): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108295|NCT01940497|O4|Outcome|Trastuzumab (SID): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108296|NCT01940497|O3|Outcome|Trastuzumab (SID): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108297|NCT01940497|O2|Outcome|Trastuzumab (Vial): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108298|NCT01940497|O1|Outcome|Trastuzumab (Vial): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108355|NCT01940471|O1|Outcome|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108299|NCT01940497|O4|Outcome|Trastuzumab (SID): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108300|NCT01940497|O3|Outcome|Trastuzumab (SID): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108301|NCT01940497|O2|Outcome|Trastuzumab (Vial): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108302|NCT01940497|O1|Outcome|Trastuzumab (Vial): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108303|NCT01940497|O2|Outcome|Trastuzumab (SID): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108304|NCT01940497|O1|Outcome|Trastuzumab (Vial): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108305|NCT01940497|O2|Outcome|Trastuzumab (SID)|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108306|NCT01940497|O1|Outcome|Trastuzumab (Vial)|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108307|NCT01940497|O4|Outcome|Trastuzumab (SID): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108308|NCT01940497|O3|Outcome|Trastuzumab (SID): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108309|NCT01940497|O2|Outcome|Trastuzumab (Vial): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108310|NCT01940497|O1|Outcome|Trastuzumab (Vial): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108311|NCT01940497|O4|Outcome|Trastuzumab (SID): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108312|NCT01940497|O3|Outcome|Trastuzumab (SID): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108313|NCT01940497|O2|Outcome|Trastuzumab (Vial): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108314|NCT01940497|O1|Outcome|Trastuzumab (Vial): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108315|NCT01940497|O4|Outcome|Trastuzumab (SID): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108316|NCT01940497|O3|Outcome|Trastuzumab (SID): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108317|NCT01940497|O2|Outcome|Trastuzumab (Vial): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108318|NCT01940497|O1|Outcome|Trastuzumab (Vial): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108319|NCT01940497|E2|Reported Event|Trastuzumab (SID)|Participants received trastuzumab 600 mg subcutaneously using single-use injection device (SID) every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108320|NCT01940497|E1|Reported Event|Trastuzumab (Vial)|Participants received trastuzumab 600 milligrams (mg) subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
108321|NCT01940484|B1|Baseline|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
108322|NCT01940484|P1|Participant Flow|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta (Mircera) as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
108323|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
108324|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
108325|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
108326|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
108327|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
108328|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
108329|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
108330|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
108331|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
108332|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
108333|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
108334|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
108335|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
108336|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
108337|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
108338|NCT01940484|E1|Reported Event|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
108339|NCT01940471|B3|Baseline|Total|Total of all reporting groups
108340|NCT01940471|B2|Baseline|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108341|NCT01940471|B1|Baseline|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108342|NCT01940471|P2|Participant Flow|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108343|NCT01940471|P1|Participant Flow|TAF 25 mg|Tenofovir alafenamide (Vemlidy®; TAF) 25 mg tablet + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108344|NCT01940471|O2|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108345|NCT01940471|O1|Outcome|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108346|NCT01940471|O2|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108347|NCT01940471|O1|Outcome|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108348|NCT01940471|O2|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108349|NCT01940471|O1|Outcome|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108350|NCT01940471|O2|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108351|NCT01940471|O1|Outcome|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108352|NCT01940471|O2|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108353|NCT01940471|O1|Outcome|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108357|NCT01940471|E1|Reported Event|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108358|NCT01940354|B3|Baseline|Total|Total of all reporting groups
108359|NCT01940354|B2|Baseline|Vascular Access Via Control Device|"Conventional IV Catheter (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal.~Conventional IV catheters: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples"
108360|NCT01940354|B1|Baseline|Vascular Access Via Study Device|"AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal.~AccuCath IV device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
108361|NCT01940354|P2|Participant Flow|Vascular Access Via Control Device|"Conventional IV Catheter (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal.~Conventional IV catheters: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples"
108362|NCT01940354|P1|Participant Flow|Vascular Access Via Study Device|"AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal.~AccuCath IV device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
108363|NCT01940354|O2|Outcome|Vascular Access Via Control Device|"Conventional IV Catheter (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal.~Conventional IV catheters: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples"
108364|NCT01940354|O1|Outcome|Vascular Access Via Study Device|"AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal.~AccuCath IV device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
108365|NCT01940354|O2|Outcome|Vascular Access Via Control Device|"Conventional IV Catheter (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal.~Conventional IV catheters: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples"
108366|NCT01940354|O1|Outcome|Vascular Access Via Study Device|"AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal.~AccuCath IV device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
108367|NCT01940354|O2|Outcome|Vascular Access Via Control Device|"Conventional IV Catheter (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal.~Conventional IV catheters: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples"
108368|NCT01940354|O1|Outcome|Vascular Access Via Study Device|"AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal.~AccuCath IV device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
108369|NCT01940354|E2|Reported Event|Vascular Access Via Control Device|"Conventional IV Catheter (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal.~Conventional IV catheters: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
108370|NCT01940354|E1|Reported Event|Vascular Access Via Study Device|"AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal.~AccuCath IV device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
108371|NCT01940341|B3|Baseline|Total|Total of all reporting groups
108372|NCT01940341|B2|Baseline|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108373|NCT01940341|B1|Baseline|TAF 25 mg|TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108374|NCT01940341|P2|Participant Flow|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108375|NCT01940341|P1|Participant Flow|TAF 25 mg|Tenofovir alafenamide (Vemlidy®; TAF) 25 mg + tenofovir disoproxil fumarate (TDF) placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108376|NCT01940341|O2|Outcome|TDF + TAF Placebo|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108377|NCT01940341|O1|Outcome|TAF + TDF Placebo|TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108378|NCT01940341|O2|Outcome|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108379|NCT01940341|O1|Outcome|TAF 25 mg|TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108380|NCT01940341|O2|Outcome|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108381|NCT01940341|O1|Outcome|TAF 25 mg|TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108382|NCT01940341|O2|Outcome|TDF + TAF Placebo|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108647|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
108383|NCT01940341|O1|Outcome|TAF + TDF Placebo|TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108384|NCT01940341|O2|Outcome|TDF + TAF Placebo|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108385|NCT01940341|O1|Outcome|TAF + TDF Placebo|TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108386|NCT01940341|E2|Reported Event|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108387|NCT01940341|E1|Reported Event|TAF 25 mg|TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
108388|NCT01940146|B5|Baseline|Total|Total of all reporting groups
108389|NCT01940146|B4|Baseline|SPARC1310 III|S0597 high dose: S0597 high dose
108390|NCT01940146|B3|Baseline|SPARC1310 II|S0597 mid dose: S0597 mid dose
108391|NCT01940146|B2|Baseline|SPARC1310 I|Baseline characteristics: Age
108392|NCT01940146|B1|Baseline|SPARC Placebo|Baseline characteristics: Age
108393|NCT01940146|P4|Participant Flow|SPARC1310 III|SPARC1310 III was administered as two sprays/nostril QD
108394|NCT01940146|P3|Participant Flow|SPARC1310 II|SPARC1310 II was administered as two sprays/nostril QD
108395|NCT01940146|P2|Participant Flow|SPARC1310 I|SPARC1310 I was administered as two sprays /nostril QD
108396|NCT01940146|P1|Participant Flow|SPARC Placebo|SPARC Placebo was administered as sprays/nostril QD
108397|NCT01940146|O4|Outcome|S0597 High Dose|S0597 high dose: S0597 high dose
108398|NCT01940146|O3|Outcome|S0597 Mid Dose|S0597 mid dose: S0597 mid dose
108399|NCT01940146|O2|Outcome|S0597 Low Dose|S0597 low dose: S0597 low dose
108400|NCT01940146|O1|Outcome|Placebo|Placebo: Placebo
108401|NCT01940146|E4|Reported Event|SPARC1310 III|SPARC1310 III administration
108402|NCT01940146|E3|Reported Event|SPARC1310 II|SPARC1310 II administration
108403|NCT01940146|E2|Reported Event|SPARC1310 I|SPARC1310 I administration
108404|NCT01940146|E1|Reported Event|SPARC Placebo|SPARC Placebo administration
108405|NCT01940120|B1|Baseline|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108406|NCT01940120|P1|Participant Flow|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108407|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108408|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108409|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108410|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108411|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108412|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108413|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108414|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108415|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108416|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
109769|NCT01937026|O1|Outcome|Baricitinib|4 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.
108417|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108418|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108419|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108420|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108421|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108422|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108423|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108424|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108425|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108426|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108427|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108428|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108429|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108430|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108431|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108432|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108433|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108434|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108435|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108436|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108437|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108438|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108439|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108440|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108441|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108442|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108443|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108444|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108445|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108446|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108447|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108448|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108449|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108450|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108451|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108452|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108453|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108454|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108455|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108456|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108457|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108458|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108459|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108460|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108461|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108462|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108463|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108464|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108465|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108466|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108467|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108468|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108469|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108470|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108471|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108472|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108473|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108474|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108475|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108476|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108477|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108478|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108479|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108480|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108481|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108482|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108483|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108484|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108485|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108486|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108487|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108488|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108489|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108490|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108491|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108492|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108493|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108494|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108495|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108496|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108497|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108498|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108499|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108500|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108501|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108502|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108503|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108504|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108505|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108506|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108507|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108508|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108509|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108510|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108511|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108512|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108513|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108514|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108515|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108516|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108517|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108518|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108519|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108520|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108521|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108522|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108523|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108524|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108525|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108526|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108527|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108528|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108529|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108530|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108531|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108532|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108533|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108534|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108535|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108536|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108537|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108538|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108539|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108540|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108541|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108542|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108543|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108544|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108545|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108546|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108547|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108548|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108549|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108550|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108551|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108552|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108553|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108554|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108555|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108556|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108557|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
108558|NCT01940120|E1|Reported Event|High Risk Registry Arm|"Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.~Percutaneous mitral valve repair using MitraClip implant: Procedure/Surgery: Mitral valve repair or replacement surgery Repair or replacement of mitral valve"
108559|NCT01939938|B1|Baseline|All Subjects-Nasal and Oronasal PAP Mask|"Each subject will be imaged in a dynamic MRI with both a oronasal and nasal mask at pressures of 5, 10, and 15 cm of H2O.~Nasal and Oronasal PAP Mask: Subjects will be imaged via MRI wearing a nasal and oronasal PAP mask at 5, 10 and 15 cm H20."
108560|NCT01939938|P1|Participant Flow|All Subjects-Nasal and Oronasal PAP Mask|"Each subject will be imaged in a dynamic MRI with both a oronasal and nasal mask at pressures of 5, 10, and 15 cm of H2O.~Nasal and Oronasal PAP Mask: Subjects will be imaged via MRI wearing a nasal and oronasal PAP mask at 5, 10 and 15 cm H20."
108561|NCT01939938|O2|Outcome|Residual AHI|AHI residual.
108562|NCT01939938|O1|Outcome|Baseline AHI|AHI at baseline.
108563|NCT01939938|E1|Reported Event|All Subjects-Nasal and Oronasal PAP Mask|"Each subject will be imaged in a dynamic MRI with both a oronasal and nasal mask at pressures of 5, 10, and 15 cm of H2O.~Nasal and Oronasal PAP Mask: Subjects will be imaged via MRI wearing a nasal and oronasal PAP mask at 5, 10 and 15 cm H20."
108564|NCT01939548|B4|Baseline|Total|Total of all reporting groups
108565|NCT01939548|B3|Baseline|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108566|NCT01939548|B2|Baseline|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108567|NCT01939548|B1|Baseline|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108568|NCT01939548|P3|Participant Flow|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108569|NCT01939548|P2|Participant Flow|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108570|NCT01939548|P1|Participant Flow|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108571|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108572|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108573|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108574|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108575|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108576|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108577|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108578|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108579|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108580|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108581|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108582|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108583|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108584|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108585|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108586|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108587|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108588|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108589|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108590|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108591|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108592|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108593|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108594|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108595|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108596|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108597|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108598|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108599|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108600|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108601|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108602|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108603|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108604|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108605|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108606|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108607|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108608|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108609|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108610|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108611|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108612|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108613|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108614|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108615|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108616|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108617|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108618|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108619|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108620|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108621|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108622|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108623|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108624|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108625|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108626|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108627|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108628|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108629|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108630|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108631|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108632|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108633|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108634|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108635|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108636|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108637|NCT01939548|E3|Reported Event|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108638|NCT01939548|E2|Reported Event|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108639|NCT01939548|E1|Reported Event|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
108640|NCT01939496|B4|Baseline|Total|Total of all reporting groups
108641|NCT01939496|B3|Baseline|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
108642|NCT01939496|B2|Baseline|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
108643|NCT01939496|B1|Baseline|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
108644|NCT01939496|P3|Participant Flow|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
108645|NCT01939496|P2|Participant Flow|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
108646|NCT01939496|P1|Participant Flow|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
108648|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
108649|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
108650|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
108651|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
108652|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
108653|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
108654|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
108655|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
108656|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
108657|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
108658|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
108659|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
108660|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
108661|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
108662|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
108663|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
108664|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
108665|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
108666|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
108667|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
108668|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
108669|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
108670|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
108671|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
108672|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
108673|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
108674|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
108675|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
108676|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
108677|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
108678|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
108679|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
108680|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
108681|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
108682|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
108683|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
108684|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
108685|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
108686|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
108687|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
108688|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
108689|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
108690|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
108691|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
108692|NCT01939496|E3|Reported Event|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
108693|NCT01939496|E2|Reported Event|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
108694|NCT01939496|E1|Reported Event|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
108695|NCT01939405|B3|Baseline|Total|Total of all reporting groups
108696|NCT01939405|B2|Baseline|Built Environment Use Counseling|"personalized counseling on active use of the built environment~built environment use counseling"
108697|NCT01939405|B1|Baseline|Standard Physical Activity Counseling|standard pediatric physical activity counseling
108698|NCT01939405|P2|Participant Flow|Built Environment Use Counseling|"personalized counseling on active use of the built environment~built environment use counseling"
108699|NCT01939405|P1|Participant Flow|Standard Physical Activity Counseling|standard pedatric physical activity counseling
108700|NCT01939405|O2|Outcome|Built Environment Use Counseling|"personalized counseling on active use of the built environment~built environment use counseling"
108701|NCT01939405|O1|Outcome|Standard Physical Activity Counseling|standard pedatric physical activity counseling
108702|NCT01939405|O2|Outcome|Built Environment Use Counseling|"personalized counseling on active use of the built environment~built environment use counseling"
108703|NCT01939405|O1|Outcome|Standard Physical Activity Counseling|standard pedatric physical activity counseling
108704|NCT01939405|O2|Outcome|Built Environment Use Counseling|"personalized counseling on active use of the built environment~built environment use counseling"
108705|NCT01939405|O1|Outcome|Standard Physical Activity Counseling|standard pedatric physical activity counseling
108706|NCT01939405|O2|Outcome|Built Environment Use Counseling|"personalized counseling on active use of the built environment~built environment use counseling"
108707|NCT01939405|O1|Outcome|Standard Physical Activity Counseling|standard pedatric physical activity counseling
108708|NCT01939405|E2|Reported Event|Built Environment Use Counseling|"personalized counseling on active use of the built environment~built environment use counseling"
108709|NCT01939405|E1|Reported Event|Standard Physical Activity Counseling|standard pedatric physical activity counseling
108710|NCT01939314|B3|Baseline|Total|Total of all reporting groups
108711|NCT01939314|B2|Baseline|Normal Saline|Normal Saline delivered by the Tx 360 device to the sphenopalatine ganglion bilaterally
108712|NCT01939314|B1|Baseline|Bupivacaine|Bupivacaine delivered by the Tx 360 device to the sphenopalatine ganglion bilaterally
108713|NCT01939314|P2|Participant Flow|Normal Saline|"normal saline .03 ml to each nare~Placebo: Placebo"
108714|NCT01939314|P1|Participant Flow|Bupivacaine|"Bupivicaine .03ml to each nare~Bupivacaine: intervention"
108715|NCT01939314|O2|Outcome|Normal Saline|"normal saline .03 ml to each nare~Placebo: Placebo"
108716|NCT01939314|O1|Outcome|Bupivacaine|"Bupivicaine .03ml to each nare~Bupivacaine: intervention"
108717|NCT01939314|O2|Outcome|Normal Saline|"normal saline .03 ml to each nare~Placebo: Placebo"
108718|NCT01939314|O1|Outcome|Bupivacaine|"Bupivicaine .03ml to each nare~Bupivacaine: intervention"
108719|NCT01939314|O2|Outcome|Normal Saline|Normal Saline .03ml to each nare
108720|NCT01939314|O1|Outcome|Bupivacaine|Bupivicaine .03ml to each nare
108721|NCT01939314|E2|Reported Event|Normal Saline|"normal saline .03 ml to each nare~Placebo: Placebo"
108722|NCT01939314|E1|Reported Event|Bupivacaine|"Bupivicaine .03ml to each nare~Bupivacaine: intervention"
108723|NCT01939301|B3|Baseline|Total|Total of all reporting groups
108724|NCT01939301|B2|Baseline|Sham|"oxygen~Nitrogen + Oxygen"
108725|NCT01939301|B1|Baseline|Inhaled Nitric Oxide|"Inhaled nitric oxide~Nitric Oxide + oxygen"
108726|NCT01939301|P2|Participant Flow|Sham|"oxygen~Nitrogen + Oxygen"
108727|NCT01939301|P1|Participant Flow|Inhaled Nitric Oxide|"Inhaled nitric oxide~Nitric Oxide + oxygen"
108728|NCT01939301|O2|Outcome|Sham|"oxygen~Nitrogen + Oxygen"
108729|NCT01939301|O1|Outcome|Inhaled Nitric Oxide|"Inhaled nitric oxide~Nitric Oxide + oxygen"
108730|NCT01939301|E2|Reported Event|Sham|"oxygen~Nitrogen + Oxygen"
108731|NCT01939301|E1|Reported Event|Inhaled Nitric Oxide|"Inhaled nitric oxide~Nitric Oxide + oxygen"
108732|NCT01939223|B3|Baseline|Total|Total of all reporting groups
108733|NCT01939223|B2|Baseline|Placebo|Subjects received placebo matching to regorafenib tablet orally once daily on a 3 weeks on / 1 week off dosing schedule.
108734|NCT01939223|B1|Baseline|Regorafenib 160 mg|Description: Subjects received regorafenib 160 milligram (mg) (4 * 40 mg tablets) orally once daily on a 3 weeks on / 1 week off dosing schedule.
108735|NCT01939223|P2|Participant Flow|Placebo|Subjects received placebo matching to regorafenib tablet orally once daily on a 3 weeks on / 1 week off dosing schedule.
108736|NCT01939223|P1|Participant Flow|Regorafenib 160 mg|Description: Subjects received regorafenib 160 milligram (mg) (4 * 40 mg tablets) orally once daily on a 3 weeks on / 1 week off dosing schedule.
108737|NCT01939223|O2|Outcome|Placebo|Subjects received placebo matching to regorafenib tablet orally once daily on a 3 weeks on / 1 week off dosing schedule.
108738|NCT01939223|O1|Outcome|Regorafenib 160 mg|Description: Subjects received regorafenib 160 milligram (mg) (4 * 40 mg tablets) orally once daily on a 3 weeks on / 1 week off dosing schedule.
108739|NCT01939223|O2|Outcome|Placebo|Subjects received placebo matching to regorafenib tablet orally once daily on a 3 weeks on / 1 week off dosing schedule.
108740|NCT01939223|O1|Outcome|Regorafenib 160 mg|Description: Subjects received regorafenib 160 milligram (mg) (4 * 40 mg tablets) orally once daily on a 3 weeks on / 1 week off dosing schedule.
108741|NCT01939223|E2|Reported Event|Placebo|Subjects received placebo matched to regorafenib tablets orally every day for 3 weeks followed by 1 week off treatment plus BSC (best supportive care).
108742|NCT01939223|E1|Reported Event|Regorafenib 160 mg (BAY73-4506)|Subjects received regorafenib 160 mg (4 *40 mg tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC (best supportive care).
108743|NCT01939197|B8|Baseline|Total|Total of all reporting groups
108744|NCT01939197|B7|Baseline|Part 2: GT4 Analysis Group|Arm K: ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily Arm L: no participants enrolled
108745|NCT01939197|B6|Baseline|Part 2: Arm G|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
108746|NCT01939197|B5|Baseline|Part 2: GT1 Analysis Group|Participants with HCV GT1a or GT1b at screening in Arms E, F, H, I, J (no participants enrolled in Arm H) Arm E: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm F: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm I: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm J: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
108747|NCT01939197|B4|Baseline|Part 1b: Arm D|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily
108748|NCT01939197|B3|Baseline|Part 1b: Arm C|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily
108749|NCT01939197|B2|Baseline|Part 1a: Arm B|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
108750|NCT01939197|B1|Baseline|Part 1a: Arm A|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
108751|NCT01939197|P7|Participant Flow|GT4 Analysis Group|"Participants with HCV GT4 at screening in Arms K and L (no participants enrolled in Arm L).~Arm K: ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily"
108752|NCT01939197|P6|Participant Flow|Part 2: Arm G|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
108753|NCT01939197|P5|Participant Flow|Part 2: GT1 Analysis Group|Participants with HCV genotype (GT)1a or GT1b at screening in Arms E, F, H, I, J (no participants enrolled in Arm H) Arm E: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm F: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm I: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm J: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
108754|NCT01939197|P4|Participant Flow|Part 1b: Arm D|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily
108755|NCT01939197|P3|Participant Flow|Part 1b: Arm C|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily
108756|NCT01939197|P2|Participant Flow|Part 1a: Arm B|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
108757|NCT01939197|P1|Participant Flow|Part 1a: Arm A|ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
108758|NCT01939197|O7|Outcome|Group 2: Arm K|ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily
108759|NCT01939197|O6|Outcome|Part 2: GT4 Analysis Group|Arm K: ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily Arm L: no participants enrolled
108760|NCT01939197|O5|Outcome|Part 2: Arm J|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
108761|NCT01939197|O4|Outcome|Part 2: Arm I|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
108762|NCT01939197|O3|Outcome|Part 2: Arm F|ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
108763|NCT01939197|O2|Outcome|Part 2: Arm E|ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
108764|NCT01939197|O1|Outcome|Part 2: GT1 Analysis Group|Participants with HCV GT1a or GT1b at screening in Arms E, F, H, I, J (no participants enrolled in Arm H) Arm E: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm F: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm I: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm J: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
108765|NCT01939197|O3|Outcome|Part 1b Total|"Arm C: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily~Arm D: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily"
108766|NCT01939197|O2|Outcome|Part 1b: Arm D|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily
108767|NCT01939197|O1|Outcome|Part 1b: Arm C|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily
108768|NCT01939197|O2|Outcome|Part 1a: Arm B|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
108769|NCT01939197|O1|Outcome|Part 1a: Arm A|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
108770|NCT01939197|O7|Outcome|Group 2: Arm K|ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily
108771|NCT01939197|O6|Outcome|Part 2: GT4 Analysis Group|Arm K: ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily Arm L: no participants enrolled
108772|NCT01939197|O5|Outcome|Part 2: Arm J|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
108773|NCT01939197|O4|Outcome|Part 2: Arm I|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
108774|NCT01939197|O3|Outcome|Part 2: Arm F|ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
108775|NCT01939197|O2|Outcome|Part 2: Arm E|ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
108776|NCT01939197|O1|Outcome|Part 2: GT1 Analysis Group|Participants with HCV GT1a or GT1b at screening in Arms E, F, H, I, J (no participants enrolled in Arm H) Arm E: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm F: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm I: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm J: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
108777|NCT01939197|O3|Outcome|Part 1b: Total|"Arm C: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily~Arm D: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily"
108778|NCT01939197|O2|Outcome|Part 1b: Arm D|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily
108779|NCT01939197|O1|Outcome|Part 1b: Arm C|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily
108780|NCT01939197|O2|Outcome|Part 1a: Arm B|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
108781|NCT01939197|O1|Outcome|Part 1a: Arm A|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
108782|NCT01939197|O7|Outcome|Group 2: Arm K|ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily
108783|NCT01939197|O6|Outcome|Part 2: GT4 Analysis Group|ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily Arm L: no participants enrolled
108784|NCT01939197|O5|Outcome|Part 2: Arm J|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
108785|NCT01939197|O4|Outcome|Part 2: Arm I|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
108786|NCT01939197|O3|Outcome|Part 2: Arm F|ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
108787|NCT01939197|O2|Outcome|Part 2: Arm E|ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
108788|NCT01939197|O1|Outcome|Part 2: GT1 Analysis Group|Participants with HCV GT1a or GT1b at screening in Arms E, F, H, I, J (no participants enrolled in Arm H) Arm E: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm F: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm I: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm J: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
108789|NCT01939197|O3|Outcome|Part 1b: Total|"Arm C: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily~Arm D: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily"
108790|NCT01939197|O2|Outcome|Part 1b: Arm D|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily
108791|NCT01939197|O1|Outcome|Part 1b: Arm C|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily
108792|NCT01939197|O2|Outcome|Part 1a: Arm B|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
108793|NCT01939197|O1|Outcome|Part 1a: Arm A|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
108794|NCT01939197|O2|Outcome|Part 2: Arm K|ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily
108795|NCT01939197|O1|Outcome|Part 2: GT4 Analysis Group|Arm K: ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily Arm L: no participants enrolled
108796|NCT01939197|O2|Outcome|Part 2: Arm G|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
108797|NCT01939197|O1|Outcome|Part 2: Arm F|ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
109333|NCT01937975|B3|Baseline|Healthy Participants|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
108798|NCT01939197|O3|Outcome|Part 1b: Total|"Arm C: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily~Arm D: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily"
108799|NCT01939197|O2|Outcome|Part 1b: Arm D|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily
108800|NCT01939197|O1|Outcome|Part 1b: Arm C|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily
108801|NCT01939197|O2|Outcome|Part 1a: Arm B|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
108802|NCT01939197|O1|Outcome|Part 1a: Arm A|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
108803|NCT01939197|O1|Outcome|Part 2: GT1 Analysis Group|Participants with HCV GT1a or GT1b at screening in Arms E, F, H, I, J (no participants enrolled in Arm H) Arm E: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm F: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm I: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm J: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
108804|NCT01939197|E10|Reported Event|Part 2: Arm K|ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily
108805|NCT01939197|E9|Reported Event|Part 2: Arm J|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
108806|NCT01939197|E8|Reported Event|Part 2: Arm I|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
108807|NCT01939197|E7|Reported Event|Part 2: Arm G|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
108808|NCT01939197|E6|Reported Event|Part 2: Arm F|ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
108809|NCT01939197|E5|Reported Event|Part 2: Arm E|ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
108810|NCT01939197|E4|Reported Event|Part 1b: Arm D|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily
108811|NCT01939197|E3|Reported Event|Part 1b: Arm C|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily
108812|NCT01939197|E2|Reported Event|Part 1a: Arm B|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
108813|NCT01939197|E1|Reported Event|Part 1a: Arm A|ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
108814|NCT01939145|B3|Baseline|Total|Total of all reporting groups
108815|NCT01939145|B2|Baseline|Prontosan|"The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.~Prontosan: Prontosan (B Braun, Bethlehem, PA) is 0.1% polyhexanide, 0.1% betaine, sodium hydroxide, and purified water. The polyhexanide is an antiseptic and betaine is a surfactant. This solution is an FDA approved device indicated for topical irrigation. This solution has high tolerability with robust antimicrobial activity. Polyhexanide has been utilized as the instillation solution for NPWTi with positive clinical results. Prontosan is currently being used as the instillation solution for NPWTi in this facility as the SOC. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies."
108816|NCT01939145|B1|Baseline|Normal Saline|"The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.~Normal saline: Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies"
108817|NCT01939145|P2|Participant Flow|Prontosan|"The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.~Prontosan: Prontosan (B Braun, Bethlehem, PA) is 0.1% polyhexanide, 0.1% betaine, sodium hydroxide, and purified water. The polyhexanide is an antiseptic and betaine is a surfactant. This solution is an FDA approved device indicated for topical irrigation. This solution has high tolerability with robust antimicrobial activity. Polyhexanide has been utilized as the instillation solution for NPWTi with positive clinical results. Prontosan is currently being used as the instillation solution for NPWTi in this facility as the SOC. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies."
108818|NCT01939145|P1|Participant Flow|Normal Saline|"The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.~Normal saline: Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies"
108819|NCT01939145|O2|Outcome|Prontosan|"The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.~Prontosan: Prontosan (B Braun, Bethlehem, PA) is 0.1% polyhexanide, 0.1% betaine, sodium hydroxide, and purified water. The polyhexanide is an antiseptic and betaine is a surfactant. This solution is an FDA approved device indicated for topical irrigation. This solution has high tolerability with robust antimicrobial activity. Polyhexanide has been utilized as the instillation solution for NPWTi with positive clinical results. Prontosan is currently being used as the instillation solution for NPWTi in this facility as the SOC. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies."
108820|NCT01939145|O1|Outcome|Normal Saline|"The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.~Normal saline: Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies"
108821|NCT01939145|O2|Outcome|Prontosan|"The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.~Prontosan: Prontosan (B Braun, Bethlehem, PA) is 0.1% polyhexanide, 0.1% betaine, sodium hydroxide, and purified water. The polyhexanide is an antiseptic and betaine is a surfactant. This solution is an FDA approved device indicated for topical irrigation. This solution has high tolerability with robust antimicrobial activity. Polyhexanide has been utilized as the instillation solution for NPWTi with positive clinical results. Prontosan is currently being used as the instillation solution for NPWTi in this facility as the SOC. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies."
108822|NCT01939145|O1|Outcome|Normal Saline|"The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.~Normal saline: Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies"
108823|NCT01939145|E2|Reported Event|Prontosan|"The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.~Prontosan: Prontosan (B Braun, Bethlehem, PA) is 0.1% polyhexanide, 0.1% betaine, sodium hydroxide, and purified water. The polyhexanide is an antiseptic and betaine is a surfactant. This solution is an FDA approved device indicated for topical irrigation. This solution has high tolerability with robust antimicrobial activity. Polyhexanide has been utilized as the instillation solution for NPWTi with positive clinical results. Prontosan is currently being used as the instillation solution for NPWTi in this facility as the SOC. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies."
108824|NCT01939145|E1|Reported Event|Normal Saline|"The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.~Normal saline: Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies"
108825|NCT01939002|B3|Baseline|Total|Total of all reporting groups
108826|NCT01939002|B2|Baseline|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
108827|NCT01939002|B1|Baseline|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
108828|NCT01939002|P2|Participant Flow|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
108829|NCT01939002|P1|Participant Flow|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
108830|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
108831|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
108832|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
108847|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
108833|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
108834|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
108835|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
108836|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently
108837|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus current FLS management regimen as determined by the clinician
108838|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
108839|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
108840|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
108841|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
108842|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
108843|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
108844|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
108845|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
108846|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
109669|NCT01937364|O2|Outcome|Baclofen|Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
108848|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
108849|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
108850|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
108851|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
108852|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
108853|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
108854|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
108855|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
108856|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
108857|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
108858|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
108859|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
108860|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
108938|NCT01938430|P7|Participant Flow|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
108861|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
108862|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
108863|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
108864|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
108865|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
108866|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
108867|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
108868|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
108869|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
108870|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
108871|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
108872|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
108873|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
108874|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
108875|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
108876|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
108877|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
108878|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
108879|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
108880|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
108881|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
108882|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
108883|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
108884|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
108885|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
108886|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
108887|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
108888|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
109670|NCT01937364|O1|Outcome|Placebo|Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.
108889|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
108890|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
108891|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently."
108892|NCT01939002|E2|Reported Event|BIIB017 Plus Naproxen|BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently
108893|NCT01939002|E1|Reported Event|BIIB017 Plus Current FLS Therapy|BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus current FLS management regimen as determined by the clinician
108894|NCT01938989|B1|Baseline|Overall|Blue light filter clip-on glasses and clear clip-on glasses worn over habitual correction in a crossover assignment.
108895|NCT01938989|P2|Participant Flow|Blue Light Filter, Then Clear|Blue light filter clip-on glasses first, followed by clear clip-on glasses, as worn over habitual correction
108896|NCT01938989|P1|Participant Flow|Clear, Then Blue Light Filter|Clear clip-on glasses first, followed by blue light filter clip-on glasses, as worn over habitual correction
108897|NCT01938989|O2|Outcome|Clear|Clear clip-on glasses worn over habitual correction
108898|NCT01938989|O1|Outcome|Blue Light Filter|Blue light filter clip-on glasses worn over habitual correction
108899|NCT01938989|E2|Reported Event|Clear|Clear clip-on glasses worn over habitual correction
108900|NCT01938989|E1|Reported Event|Blue Light Filter|Blue light filter clip-on glasses worn over habitual correction
108901|NCT01938833|B1|Baseline|Treatment (Romidepsin and Abraxane)|"Patients receive abraxane IV over 30 minutes and romidepsin IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Romidepsin~Abraxane"
108902|NCT01938833|P1|Participant Flow|Treatment (Romidepsin and Abraxane)|"Patients receive abraxane IV over 30 minutes and romidepsin IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Romidepsin~Abraxane"
108903|NCT01938833|O1|Outcome|Treatment (Romidepsin and Abraxane)|"Patients receive abraxane IV over 30 minutes and romidepsin IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Romidepsin~Abraxane"
108904|NCT01938833|O1|Outcome|Treatment (Romidepsin and Abraxane)|"Patients receive abraxane IV over 30 minutes and romidepsin IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Romidepsin~Abraxane"
108905|NCT01938833|O1|Outcome|Treatment (Romidepsin and Abraxane)|"Patients receive abraxane IV over 30 minutes and romidepsin IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Romidepsin~Abraxane"
108906|NCT01938833|O1|Outcome|Treatment (Romidepsin and Abraxane)|"Patients receive abraxane IV over 30 minutes and romidepsin IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Romidepsin~Abraxane"
108907|NCT01938833|O1|Outcome|Treatment (Romidepsin and Abraxane)|"Patients receive abraxane IV over 30 minutes and romidepsin IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Romidepsin~Abraxane"
108908|NCT01938833|E1|Reported Event|Treatment (Romidepsin and Abraxane)|"Patients receive abraxane IV over 30 minutes and romidepsin IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Romidepsin~Abraxane"
108909|NCT01938573|B1|Baseline|Sirolimus, Cisplatin, Gemcitabine|"Sirolimus day -2, cisplatin 70 mg/m2 IV Day 1 and gemcitabine hydrochloride 1000 mg/m2 IV days 1 and 8 every 21 days for 4 cycles followed by cystectomy (surgery)~Cisplatin: Given IV~Gemcitabine Hydrochloride: Given IV~Sirolimus: Given PO~Cystectomy: Undergo cystectomy when appropriate"
108910|NCT01938573|P2|Participant Flow|Phase I|Sirolimus 35 mg PO day -2, cisplatin 70 mg/m2 day 1, gemcitabine 1000 mg/m2 days 1 and 8, every 21 days
108911|NCT01938573|P1|Participant Flow|Phase 2|"Sirolimus day -2, cisplatin 70 mg/m2 IV Day 1 and gemcitabine hydrochloride 1000 mg/m2 IV days 1 and 8 every 21 days for 4 cycles followed by cystectomy (surgery)~Cisplatin: Given IV~Gemcitabine Hydrochloride: Given IV~Sirolimus: Given PO~Cystectomy: Undergo cystectomy when appropriate"
108912|NCT01938573|O1|Outcome|Sirolimus, Cisplatin, Gemcitabine|"Sirolimus day -2, cisplatin 70 mg/m2 IV Day 1 and gemcitabine hydrochloride 1000 mg/m2 IV days 1 and 8 every 21 days for 4 cycles followed by cystectomy (surgery)~Cisplatin: Given IV~Gemcitabine Hydrochloride: Given IV~Sirolimus: Given PO~Cystectomy: Undergo cystectomy when appropriate"
108913|NCT01938573|O1|Outcome|Sirolimus, Cisplatin, Gemcitabine|"Sirolimus day -2, cisplatin 70 mg/m2 IV Day 1 and gemcitabine hydrochloride 1000 mg/m2 IV days 1 and 8 every 21 days for 4 cycles followed by cystectomy (surgery)~Cisplatin: Given IV~Gemcitabine Hydrochloride: Given IV~Sirolimus: Given PO~Cystectomy: Undergo cystectomy when appropriate"
108939|NCT01938430|P6|Participant Flow|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
108914|NCT01938573|O1|Outcome|Phase 1 - Sirolimus, Cisplatin, Gemcitabine|"Sirolimus day -2, cisplatin 70 mg/m2 IV Day 1 and gemcitabine hydrochloride 1000 mg/m2 IV days 1 and 8 every 21 days~Cisplatin: Given IV~Gemcitabine Hydrochloride: Given IV~Sirolimus: Given PO~Cystectomy: Undergo cystectomy when appropriate"
108915|NCT01938573|E1|Reported Event|Sirolimus, Cisplatin, Gemcitabine|"Sirolimus day -2, cisplatin 70 mg/m2 IV Day 1 and gemcitabine hydrochloride 1000 mg/m2 IV days 1 and 8 every 21 days for 4 cycles followed by cystectomy (surgery)~Cisplatin: Given IV~Gemcitabine Hydrochloride: Given IV~Sirolimus: Given PO~Cystectomy: Undergo cystectomy when appropriate"
108916|NCT01938430|B15|Baseline|Total|Total of all reporting groups
108917|NCT01938430|B14|Baseline|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
108918|NCT01938430|B13|Baseline|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
108919|NCT01938430|B12|Baseline|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
108920|NCT01938430|B11|Baseline|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
108921|NCT01938430|B10|Baseline|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
108922|NCT01938430|B9|Baseline|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
108923|NCT01938430|B8|Baseline|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
108924|NCT01938430|B7|Baseline|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
108925|NCT01938430|B6|Baseline|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
108926|NCT01938430|B5|Baseline|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
108927|NCT01938430|B4|Baseline|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
108928|NCT01938430|B3|Baseline|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
108929|NCT01938430|B2|Baseline|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
108930|NCT01938430|B1|Baseline|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
108931|NCT01938430|P14|Participant Flow|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
108932|NCT01938430|P13|Participant Flow|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
108933|NCT01938430|P12|Participant Flow|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
108934|NCT01938430|P11|Participant Flow|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
108935|NCT01938430|P10|Participant Flow|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
108936|NCT01938430|P9|Participant Flow|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
108937|NCT01938430|P8|Participant Flow|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
108940|NCT01938430|P5|Participant Flow|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|"LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3~F0: no fibrosis; F1: portal fibrosis without septa; F2: portal fibrosis with rare septa, F3: numerous septa without cirrhosis; F4: cirrhosis"
108941|NCT01938430|P4|Participant Flow|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
108942|NCT01938430|P3|Participant Flow|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
108943|NCT01938430|P2|Participant Flow|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
108944|NCT01938430|P1|Participant Flow|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|"Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily plus ribavirin (RBV) tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with Child-Pugh-Turcotte (CPT) Class B (CPT score 7-9).~CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for study was 12); higher scores indicate greater severity of disease."
108945|NCT01938430|O11|Outcome|Cohort B: Baseline CPT Class C (24 wk)|Includes participants in Cohort B (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
108946|NCT01938430|O10|Outcome|Cohort B: Baseline CPT Class C (12 wk)|Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
108947|NCT01938430|O9|Outcome|Cohort B: Baseline CPT Class B (24 wk)|Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
108948|NCT01938430|O8|Outcome|Cohort B: Baseline CPT Class B (12 wk)|Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
108949|NCT01938430|O7|Outcome|Cohort B: Baseline CPT Class A (24 wk)|Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
108950|NCT01938430|O6|Outcome|Cohort B: Baseline CPT Class A (12 wk)|Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
108951|NCT01938430|O5|Outcome|Cohort A: Baseline CPT Class C (24 wk)|Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
108952|NCT01938430|O4|Outcome|Cohort A: Baseline CPT Class C (12 wk)|Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
108953|NCT01938430|O3|Outcome|Cohort A: Baseline CPT Class B (24 wk)|Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
108954|NCT01938430|O2|Outcome|Cohort A: Baseline CPT Class B (12 wk)|Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
108955|NCT01938430|O1|Outcome|Cohort A: Baseline CPT Class A (24 wk)|Includes participants in Cohort A (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
108956|NCT01938430|O10|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
108957|NCT01938430|O9|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
108958|NCT01938430|O8|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
108959|NCT01938430|O7|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
108960|NCT01938430|O6|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
108961|NCT01938430|O5|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
108962|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
108963|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
108964|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
108965|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
108966|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
108967|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
108968|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
108969|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
108970|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
108971|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
108972|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
108973|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
108974|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
108975|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
108976|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
108977|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
108978|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
108979|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
108980|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
108981|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
108982|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
108983|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
108984|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
108985|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109671|NCT01937364|E2|Reported Event|Baclofen|Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
108986|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
108987|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
108988|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
108989|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
108990|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
108991|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
108992|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
108993|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
108994|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
108995|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
108996|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
108997|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
108998|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
108999|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109000|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
109001|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
109002|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
109003|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
109004|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109005|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109006|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109007|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109008|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
109009|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
109010|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109011|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109012|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109013|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109014|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
109015|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
109016|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
109017|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
109018|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109019|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109020|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109021|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109022|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
109023|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
109024|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109025|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109026|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109027|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109028|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
109029|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
109030|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
109031|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
109032|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109080|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
109033|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109034|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109035|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109036|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
109037|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
109038|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109039|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109040|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109041|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109042|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
109043|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
109044|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
109045|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
109046|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109047|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109048|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109049|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109050|NCT01938430|O7|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
109051|NCT01938430|O6|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109052|NCT01938430|O5|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109053|NCT01938430|O4|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
109054|NCT01938430|O3|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
109055|NCT01938430|O2|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109334|NCT01937975|B2|Baseline|Participants With Severe Renal Impairment|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109056|NCT01938430|O1|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109057|NCT01938430|O7|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
109058|NCT01938430|O6|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109059|NCT01938430|O5|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109060|NCT01938430|O4|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
109061|NCT01938430|O3|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
109062|NCT01938430|O2|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109063|NCT01938430|O1|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109064|NCT01938430|O7|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
109065|NCT01938430|O6|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109066|NCT01938430|O5|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109067|NCT01938430|O4|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
109068|NCT01938430|O3|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
109069|NCT01938430|O2|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109070|NCT01938430|O1|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109071|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
109072|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
109073|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109074|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109075|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109076|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109077|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
109078|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
109079|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
109081|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109082|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109083|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109084|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109085|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
109086|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
109087|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109088|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109089|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109090|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109091|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
109092|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
109093|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
109094|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
109095|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109096|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109097|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109098|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109099|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
109100|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
109101|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109102|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109103|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109672|NCT01937364|E1|Reported Event|Placebo|Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.
109104|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109105|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
109106|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
109107|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
109108|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
109109|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109110|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109111|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109112|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109113|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
109114|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
109115|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109116|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109117|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109118|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109119|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
109120|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
109121|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
109122|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
109123|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109124|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109125|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109126|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109127|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
109128|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
109129|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109130|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109131|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109132|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109133|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
109134|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
109135|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
109136|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
109137|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109138|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109139|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109140|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109141|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
109142|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
109143|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109144|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109145|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109146|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109147|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
109148|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
109149|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
109150|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
109151|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109152|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109153|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109154|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109155|NCT01938430|O1|Outcome|All LDV/SOF+RBV|All participants in the analysis are presented in a single group, regardless of randomization group assignment.
109156|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
109157|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
109158|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109159|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109160|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109161|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109162|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
109163|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
109164|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
109165|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
109166|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109167|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109168|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109169|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109170|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
109171|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
109172|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109173|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109174|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109175|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109176|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
109177|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
109178|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
109179|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
109180|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109181|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109182|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109183|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109184|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
109185|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
109186|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109187|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109188|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109189|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109190|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
109191|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
109192|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
109193|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
109194|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109195|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109196|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109197|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109198|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
109199|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
109673|NCT01937351|B3|Baseline|Total|Total of all reporting groups
109200|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109201|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109202|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109203|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109204|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
109205|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
109206|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
109207|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
109208|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109209|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109210|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109211|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109212|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
109213|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
109214|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109215|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109216|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109217|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109218|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
109219|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
109220|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
109221|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
109222|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109246|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
109223|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109224|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109225|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109226|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
109227|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
109228|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109229|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109230|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109231|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109232|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
109233|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
109234|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
109235|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
109236|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109237|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109238|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109239|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109240|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
109241|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
109242|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109243|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109244|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109245|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109714|NCT01937260|B1|Baseline|Cohort 1|Midazolam (MDZ) 2mg oral (Day 1 and Day 9) Brodalumab 210mg SC (Day 2)
109247|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
109248|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
109249|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
109250|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109251|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109252|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109253|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109254|NCT01938430|E14|Reported Event|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
109255|NCT01938430|E13|Reported Event|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
109256|NCT01938430|E12|Reported Event|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109257|NCT01938430|E11|Reported Event|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109258|NCT01938430|E10|Reported Event|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109259|NCT01938430|E9|Reported Event|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109260|NCT01938430|E8|Reported Event|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
109261|NCT01938430|E7|Reported Event|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
109262|NCT01938430|E6|Reported Event|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
109263|NCT01938430|E5|Reported Event|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
109264|NCT01938430|E4|Reported Event|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
109265|NCT01938430|E3|Reported Event|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
109266|NCT01938430|E2|Reported Event|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
109267|NCT01938430|E1|Reported Event|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
109268|NCT01938391|B1|Baseline|Stealth 360°® OAS|"Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)~Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)"
109269|NCT01938391|P1|Participant Flow|Stealth 360°® OAS|"Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)~Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)"
109715|NCT01937260|P2|Participant Flow|Cohort 2|Brodalumab 140 mg SC (Day 1)
109270|NCT01938391|O1|Outcome|Stealth 360°® OAS|"Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)~Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)"
109271|NCT01938391|O1|Outcome|Stealth 360°® OAS|"Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)~Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)"
109272|NCT01938391|O1|Outcome|Stealth 360°® OAS|"Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)~Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)"
109273|NCT01938391|O1|Outcome|Stealth 360°® OAS|"Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)~Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)"
109274|NCT01938391|O1|Outcome|Stealth 360°® OAS|"Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)~Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)"
109275|NCT01938391|O1|Outcome|Stealth 360°® OAS|"Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)~Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)"
109276|NCT01938391|O1|Outcome|Stealth 360°® OAS|"Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)~Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)"
109277|NCT01938391|E1|Reported Event|Stealth 360°® OAS|"Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)~Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)"
109278|NCT01938170|B1|Baseline|FluMist|"Subjects receiving vaccine at home~FluMist: Subjects receiving Flumist vaccine"
109279|NCT01938170|P1|Participant Flow|FluMist|"Subjects receiving vaccine at home~FluMist: Subjects receiving Flumist vaccine"
109280|NCT01938170|O1|Outcome|FluMist|"Subjects receiving vaccine at home~FluMist: Subjects receiving Flumist vaccine"
109281|NCT01938170|O1|Outcome|FluMist|"Subjects receiving vaccine at home~FluMist: Subjects receiving Flumist vaccine"
109282|NCT01938170|E1|Reported Event|FluMist|"Subjects receiving vaccine at home~FluMist: Subjects receiving Flumist vaccine"
109283|NCT01938079|B3|Baseline|Total|Total of all reporting groups
109284|NCT01938079|B2|Baseline|Sedative With Ketamine|"Subjects will receive sedative drug regimen with Ketamine.~Ketamine: Ketamine will be initiated as a one-time 40 mg bolus of ketamine followed by a continuous intravenous infusion of 5 micrograms/kg/min at the start of ECMO.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
109285|NCT01938079|B1|Baseline|Sedative Without Ketamine|"Subjects will receive sedative drug regimen without Ketamine.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
109286|NCT01938079|P2|Participant Flow|Sedative With Ketamine|"Subjects will receive sedative drug regimen with Ketamine.~Ketamine: Ketamine will be initiated as a one-time 40 mg bolus of ketamine followed by a continuous intravenous infusion of 5 micrograms/kg/min at the start of ECMO.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
109287|NCT01938079|P1|Participant Flow|Sedative Without Ketamine|"Subjects will receive sedative drug regimen without Ketamine.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
109288|NCT01938079|O2|Outcome|Sedative With Ketamine|"Subjects will receive sedative drug regimen with Ketamine.~Ketamine: Ketamine will be initiated as a one-time 40 mg bolus of ketamine followed by a continuous intravenous infusion of 5 micrograms/kg/min at the start of ECMO.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
109289|NCT01938079|O1|Outcome|Sedative Without Ketamine|"Subjects will receive sedative drug regimen without Ketamine.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
109290|NCT01938079|E2|Reported Event|Sedative With Ketamine|"Subjects will receive sedative drug regimen with Ketamine.~Ketamine: Ketamine will be initiated as a one-time 40 mg bolus of ketamine followed by a continuous intravenous infusion of 5 micrograms/kg/min at the start of ECMO.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
109291|NCT01938079|E1|Reported Event|Sedative Without Ketamine|"Subjects will receive sedative drug regimen without Ketamine.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
109292|NCT01938066|B3|Baseline|Total|Total of all reporting groups
109293|NCT01938066|B2|Baseline|Negative Pressure Therapy Only|"Arm 1 is Negative Pressure Therapy only with no Procellera Dressing and the dressing is changed every other day per standard of care when you use Negative Pressure Therapy with no dressing underneath the sponge.~negative pressure therapy"
109294|NCT01938066|B1|Baseline|Negative Pressure With Procellera|"Arm 2 is Negative Pressure Therapy and Procellera Dressing under the sponge dressing of the Negative Pressure Therapy. The dressing will be changed at the end of 5 days. This is the intervention arm of the study.~Procellera: bioelectric wound dressing~negative pressure therapy"
109295|NCT01938066|P2|Participant Flow|Negative Pressure Therapy Only|"Arm 1 is Negative Pressure Therapy only with no Procellera Dressing and the dressing is changed every other day per standard of care when you use Negative Pressure Therapy with no dressing underneath the sponge.~negative pressure therapy"
109296|NCT01938066|P1|Participant Flow|Negative Pressure With Procellera|"Arm 2 is Negative Pressure Therapy and Procellera Dressing under the sponge dressing of the Negative Pressure Therapy. The dressing will be changed at the end of 5 days. This is the intervention arm of the study.~Procellera: bioelectric wound dressing~negative pressure therapy"
109297|NCT01938066|O2|Outcome|Negative Pressure Therapy Only|"Arm 1 is Negative Pressure Therapy only with no Procellera Dressing and the dressing is changed every other day per standard of care when you use Negative Pressure Therapy with no dressing underneath the sponge.~negative pressure therapy"
109298|NCT01938066|O1|Outcome|Negative Pressure With Procellera|"Arm 2 is Negative Pressure Therapy and Procellera Dressing under the sponge dressing of the Negative Pressure Therapy. The dressing will be changed at the end of 5 days. This is the intervention arm of the study.~Procellera: bioelectric wound dressing~negative pressure therapy"
109299|NCT01938066|O2|Outcome|Negative Pressure Therapy Only|"Arm 1 is Negative Pressure Therapy only with no Procellera Dressing and the dressing is changed every other day per standard of care when you use Negative Pressure Therapy with no dressing underneath the sponge.~negative pressure therapy"
109300|NCT01938066|O1|Outcome|Negative Pressure With Procellera|"Arm 2 is Negative Pressure Therapy and Procellera Dressing under the sponge dressing of the Negative Pressure Therapy. The dressing will be changed at the end of 5 days. This is the intervention arm of the study.~Procellera: bioelectric wound dressing~negative pressure therapy"
109301|NCT01938066|E2|Reported Event|Negative Pressure Therapy Only|"Arm 1 is Negative Pressure Therapy only with no Procellera Dressing and the dressing is changed every other day per standard of care when you use Negative Pressure Therapy with no dressing underneath the sponge.~negative pressure therapy"
109302|NCT01938066|E1|Reported Event|Negative Pressure With Procellera|"Arm 2 is Negative Pressure Therapy and Procellera Dressing under the sponge dressing of the Negative Pressure Therapy. The dressing will be changed at the end of 5 days. This is the intervention arm of the study.~Procellera: bioelectric wound dressing~negative pressure therapy"
109303|NCT01938040|B3|Baseline|Total|Total of all reporting groups
109304|NCT01938040|B2|Baseline|Placebo|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
109305|NCT01938040|B1|Baseline|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
109306|NCT01938040|P2|Participant Flow|Placebo|100mL of normal saline to be administered intravenously over 5 minutes prior to surgical incision.
109307|NCT01938040|P1|Participant Flow|Caldolor/Ibuprofen|800mg administered IV in 100mL normal saline over 5 minutes prior to surgical incision.
109308|NCT01938040|O2|Outcome|Placebo|100mL of normal saline to be administered intravenously over 5 minutes prior to surgical incision.
109309|NCT01938040|O1|Outcome|Caldolor/Ibuprofen|800mg administered IV in 100mL normal saline over 5 minutes prior to surgical incision.
109310|NCT01938040|O2|Outcome|Placebo|100mL of normal saline to be administered intravenously over 5 minutes prior to surgical incision.
109311|NCT01938040|O1|Outcome|Caldolor/Ibuprofen|800mg administered IV in 100mL normal saline over 5 minutes prior to surgical incision.
109312|NCT01938040|O2|Outcome|Ibuprofen|800 mg in 100mL of normal saline over 5 minutes
109313|NCT01938040|O1|Outcome|Placebo|100mL of normal saline to be administered intravenously over 5 minutes prior to surgical incision.
109314|NCT01938040|O2|Outcome|Sugar Water|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
109315|NCT01938040|O1|Outcome|Ibuprofen|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
109316|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
109317|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
109318|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
109319|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
109320|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
109321|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
109322|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
109323|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
109324|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
109325|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
109326|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
109327|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
109328|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
109329|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
109330|NCT01938040|E2|Reported Event|Placebo|100mL of normal saline to be administered intravenously over 5 minutes prior to surgical incision.
109331|NCT01938040|E1|Reported Event|Caldolor/Ibuprofen|800mg administered IV in 100mL normal saline over 5 minutes prior to surgical incision.
109332|NCT01937975|B4|Baseline|Total|Total of all reporting groups
109335|NCT01937975|B1|Baseline|Participants With End Stage Renal Disease on Hemodialysis|Participants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109336|NCT01937975|P3|Participant Flow|Healthy Participants|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109337|NCT01937975|P2|Participant Flow|Participants With Severe Renal Impairment|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109338|NCT01937975|P1|Participant Flow|Participants With End Stage Renal Disease on Hemodialysis|Participants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109339|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. One participant was excluded due to an ill-defined terminal phase.
109340|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109341|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease: HD Day 10|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
109342|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109343|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109344|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
109345|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. One participant was excluded due to an ill-defined terminal phase.
109346|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109347|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease: HD Day 10|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
109348|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109349|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109350|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
109351|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109352|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109353|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
109354|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109355|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109356|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
109357|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109358|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (SRI, estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109383|NCT01937975|E1|Reported Event|Participants With End Stage Renal Disease on Hemodialysis|Participants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109384|NCT01937871|B4|Baseline|Total|Total of all reporting groups
109359|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
109360|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days
109361|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109362|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease: HD Day 10|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
109363|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109364|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109365|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
109366|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days
109367|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109368|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease: HD Day 10|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
109369|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109370|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109371|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
109372|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109373|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109374|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
109375|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109376|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109377|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
109378|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109379|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (SRI, estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109380|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
109381|NCT01937975|E3|Reported Event|Healthy Participants|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109382|NCT01937975|E2|Reported Event|Participants With Severe Renal Impairment|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
109621|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
109385|NCT01937871|B3|Baseline|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
109386|NCT01937871|B2|Baseline|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
109387|NCT01937871|B1|Baseline|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
109388|NCT01937871|P3|Participant Flow|0.2 mg Tamsulosin|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period.
109389|NCT01937871|P2|Participant Flow|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
109390|NCT01937871|P1|Participant Flow|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
109391|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
109392|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
109393|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
109394|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
109395|NCT01937871|O2|Outcome|5 mg Tadalafil|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period. Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period.
109396|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
109397|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
109398|NCT01937871|O2|Outcome|5 mg Tadalafil|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period. Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period.
109399|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
109400|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
109401|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
109402|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
109403|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
109404|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
109405|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
109406|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
109407|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
109408|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
109409|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period. Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period.
109410|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
109411|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
109412|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
109413|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
109414|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
109415|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period. Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period.
109716|NCT01937260|P1|Participant Flow|Cohort 1|Midazolam (MDZ) 2mg Oral (Day 1 and Day 9) Brodalumab 210 mg SC (Day 2)
109717|NCT01937260|O1|Outcome|Cohort 1|Midazolam (MDZ) 2mg oral (Day 1 and Day 9) Brodalumab 210mg SC (Day 2)
109416|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
109417|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
109418|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
109419|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
109420|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
109421|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
109422|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
109423|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
109424|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
109425|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
109426|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
109427|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
109428|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
109429|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
109430|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
109431|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
109432|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
109433|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
109434|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
109435|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
109436|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
109437|NCT01937871|O2|Outcome|5 mg Tadalafil|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period.
109438|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
109439|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
109440|NCT01937871|O2|Outcome|5 mg Tadalafil|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period.
109441|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
109442|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
109443|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
109444|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
109445|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
109446|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
109447|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
109448|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
109449|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
109450|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
109451|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
109452|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
109453|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
109454|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
109455|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
109456|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
109457|NCT01937871|E3|Reported Event|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
109458|NCT01937871|E2|Reported Event|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
109459|NCT01937871|E1|Reported Event|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
109460|NCT01937715|B6|Baseline|Total|Total of all reporting groups
109461|NCT01937715|B5|Baseline|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109462|NCT01937715|B4|Baseline|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109463|NCT01937715|B3|Baseline|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109464|NCT01937715|B2|Baseline|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109465|NCT01937715|B1|Baseline|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
109466|NCT01937715|P5|Participant Flow|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109467|NCT01937715|P4|Participant Flow|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109468|NCT01937715|P3|Participant Flow|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109469|NCT01937715|P2|Participant Flow|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109470|NCT01937715|P1|Participant Flow|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
109471|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109472|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109473|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109474|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109475|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
109476|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109477|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109478|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109479|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109480|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
109481|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109482|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109483|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109484|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109485|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
109486|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109487|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109488|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109489|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109490|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
109491|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109492|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109493|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109494|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109495|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
109496|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109622|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
109497|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109498|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109499|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109500|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
109501|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109502|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109503|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109504|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109505|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
109506|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109507|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109508|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109509|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109510|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
109511|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109512|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109513|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109514|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109515|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
109516|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109517|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109518|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109623|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
109718|NCT01937260|O1|Outcome|Cohort 1|Midazolam (MDZ) 2mg oral (Day 1 and Day 9)Brodalumab 210mg SC (Day 2)
109519|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109520|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
109521|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109522|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109523|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109524|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109525|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
109526|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109527|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109528|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109529|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109530|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
109531|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109532|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109533|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109534|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109535|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
109536|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109537|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109538|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109539|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109540|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
109624|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
109541|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109542|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109543|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109544|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109545|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
109546|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109547|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109548|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109549|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109550|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
109551|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109552|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109553|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109554|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109555|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
109556|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109557|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109558|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109559|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109560|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
109561|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109562|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109625|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
109719|NCT01937260|O1|Outcome|Cohort 1|Midazolam (MDZ) 2mg oral (Day 1 and Day 9) Brodalumab 210mg SC (Day 2)
109563|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109564|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109565|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
109566|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109567|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109568|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109569|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109570|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
109571|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109572|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109573|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109574|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109575|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
109576|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109577|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109578|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109579|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109580|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
109581|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109582|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109583|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109584|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109626|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
109585|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
109586|NCT01937715|E5|Reported Event|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109587|NCT01937715|E4|Reported Event|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109588|NCT01937715|E3|Reported Event|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109589|NCT01937715|E2|Reported Event|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
109590|NCT01937715|E1|Reported Event|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
109591|NCT01937598|B1|Baseline|All Study Participants|All study participants (cross-over design) received all interventions.
109592|NCT01937598|P2|Participant Flow|Placebo, Than Sitagliptin|Participants first received Placebo tablet before mixed meal test, after washout they then received Sitagliptin before the mixed meal test.
109593|NCT01937598|P1|Participant Flow|Sitagliptin, Then Placebo|Participants first received Sitagliptin tablet before mixed meal test, after washout they then received Placebo before the mixed meal test.
109594|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
109595|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
109596|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
109597|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
109598|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
109627|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
109628|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
109629|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
109720|NCT01937260|E2|Reported Event|Cohort 2|Brodalumab 140mg SC (Day1)
109599|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
109600|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
109601|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
109602|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
109603|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
109604|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
109605|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
109606|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
109630|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
109631|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.~no acupuncture: placebo"
109721|NCT01937260|E1|Reported Event|Cohort 1|Midazolam (MDZ) 2mg oral (Day 1 and Day 9) Brodalumab 210mg SC (Day 2)
109607|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
109608|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
109609|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
109610|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
109611|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
109612|NCT01937598|E2|Reported Event|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
109613|NCT01937598|E1|Reported Event|Sitagliptin|"Substance: Sitagliptin phosphate 1H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
109614|NCT01937520|B3|Baseline|Total|Total of all reporting groups
109615|NCT01937520|B2|Baseline|Sham/Placebo|"no acupuncture will be done on this group of subjects. Since they are under general anesthesia they will not realize they are acting as control group~no acupuncture: placebo"
109616|NCT01937520|B1|Baseline|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
109617|NCT01937520|P2|Participant Flow|Sham|"no acupuncture will be done on this group of subjects but since they will be under general anesthesia they will not be aware that they are the control group~no acupuncture: placebo"
109618|NCT01937520|P1|Participant Flow|Acupuncture|"acupuncture will be administered after anesthesia induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
109619|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
109620|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
109632|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
109633|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
109634|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
109635|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
109636|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
109637|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.~no acupuncture: placebo"
109638|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
109639|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
109640|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
109641|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
109642|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
109643|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
109644|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
109645|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.~no acupuncture: placebo"
109646|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
109647|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.~no acupuncture: placebo"
109648|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
109649|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.~no acupuncture: placebo"
109650|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
109651|NCT01937520|E2|Reported Event|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
109652|NCT01937520|E1|Reported Event|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
109653|NCT01937507|B1|Baseline|HAI With FOLFOX|"Hepatic Artery Infusion with Oxaliplatin, 5FU, and Folinic Acid~HAI with FOLFOX: HAI with FOLFOX q 3 weeks"
109654|NCT01937507|P1|Participant Flow|HAI With FOLFOX|"Hepatic Artery Infusion with Oxaliplatin, 5FU, and Folinic Acid~HAI with FOLFOX: HAI with FOLFOX q 3 weeks"
109655|NCT01937507|O1|Outcome|HAI With FOLFOX|"Hepatic Artery Infusion with Oxaliplatin, 5FU, and Folinic Acid~HAI with FOLFOX: HAI with FOLFOX q 3 weeks"
109656|NCT01937507|O1|Outcome|HAI With FOLFOX|"Hepatic Artery Infusion with Oxaliplatin, 5FU, and Folinic Acid~HAI with FOLFOX: HAI with FOLFOX q 3 weeks"
109657|NCT01937507|O1|Outcome|HAI With FOLFOX|"Hepatic Artery Infusion with Oxaliplatin, 5FU, and Folinic Acid~HAI with FOLFOX: HAI with FOLFOX q 3 weeks"
109658|NCT01937507|O1|Outcome|HAI With FOLFOX|"Hepatic Artery Infusion with Oxaliplatin, 5FU, and Folinic Acid~HAI with FOLFOX: HAI with FOLFOX q 3 weeks"
109659|NCT01937507|E1|Reported Event|HAI With FOLFOX|"Hepatic Artery Infusion with Oxaliplatin, 5FU, and Folinic Acid~HAI with FOLFOX: HAI with FOLFOX q 3 weeks"
109660|NCT01937364|B3|Baseline|Total|Total of all reporting groups
109661|NCT01937364|B2|Baseline|Baclofen|Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours
109662|NCT01937364|B1|Baseline|Placebo|Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours
109663|NCT01937364|P2|Participant Flow|Baclofen|Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
109664|NCT01937364|P1|Participant Flow|Placebo|Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.
109665|NCT01937364|O2|Outcome|Baclofen|Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
109666|NCT01937364|O1|Outcome|Placebo|Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.
109667|NCT01937364|O2|Outcome|Baclofen|Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
109674|NCT01937351|B2|Baseline|Roll-In Cohort|The Roll-In Cohort consists of either the 1st subject or 1st and 2nd subjects treated at each site prior to enrollment of subjects into the Primary Cohort. Roll-Ins were designed to provide the Investigator an opportunity to gain experience with the Pantheris System (Catheter and Optical Coherence Tomography-assisted orientation) for learning curve purposes. Certain sites were exempt from enrolling in the Roll-In Cohort.
109675|NCT01937351|B1|Baseline|Primary Cohort|"The Primary Cohort consisted of either the 1st subject enrolled after the Roll-In cohort or the 1st subject enrolled if the site did not utilize Roll-In subjects.~The Primary Cohort was analyzed as two separate sub-cohorts: Intention to Treat and Per Protocol. The Intention to Treat Cohort includes all subjects that were enrolled. The Per Protocol Cohort includes subjects who were enrolled, and had the Pantheris Catheter or Occlusion Sheath device inserted into the vasculature. To be included in this cohort, the Pantheris Catheter also had to be successfully advanced to the intended target lesion. This cohort is a subset of subjects enrolled into the Intention to Treat Cohort.~The Primary Per Protocol Cohort was the cohort used to determine if the primary endpoints of the VISION Study were met."
109676|NCT01937351|P2|Participant Flow|Roll-in Group|Atherectomy with Pantheris System
109677|NCT01937351|P1|Participant Flow|Primary Cohort|Atherectomy with Pantheris System
109678|NCT01937351|O1|Outcome|Per Protocol Cohort|Atherectomy with Pantheris System
109679|NCT01937351|O1|Outcome|Per Protocol Cohort|Atherectomy with Pantheris System
109680|NCT01937351|O1|Outcome|Per Protocol Cohort|Atherectomy with Pantheris System
109681|NCT01937351|E1|Reported Event|Primary Cohort|Pantheris System
109682|NCT01937312|B3|Baseline|Total|Total of all reporting groups
109683|NCT01937312|B2|Baseline|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
109684|NCT01937312|B1|Baseline|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
109685|NCT01937312|P2|Participant Flow|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
109686|NCT01937312|P1|Participant Flow|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
109687|NCT01937312|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
109688|NCT01937312|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
109689|NCT01937312|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
109690|NCT01937312|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
109691|NCT01937312|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
109692|NCT01937312|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
109693|NCT01937312|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
109694|NCT01937312|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
109695|NCT01937312|E3|Reported Event|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
109696|NCT01937312|E2|Reported Event|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
109697|NCT01937312|E1|Reported Event|Pre-Treatment|Prostaglandin analogue, 1 drop in each eye at bedtime for a 4-week run-in period
109698|NCT01937299|B3|Baseline|Total|Total of all reporting groups
109699|NCT01937299|B2|Baseline|Vehicle|1 drop instilled 3 times a day in each eye for 6 weeks in conjunction with travoprost ophthalmic solution 0.004%
109700|NCT01937299|B1|Baseline|SIMBRINZA|1 drop instilled 3 times a day in each eye for 6 weeks as adjunctive therapy to travoprost ophthalmic solution 0.004%
109701|NCT01937299|P2|Participant Flow|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
109702|NCT01937299|P1|Participant Flow|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
109703|NCT01937299|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
109704|NCT01937299|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
109705|NCT01937299|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
109706|NCT01937299|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
109707|NCT01937299|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
109708|NCT01937299|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
109709|NCT01937299|E3|Reported Event|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime for a 6-week treatment period
109710|NCT01937299|E2|Reported Event|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime for a 6-week treatment period
109711|NCT01937299|E1|Reported Event|Pre-Treatment|Travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime for a 4-week run-in period
109712|NCT01937260|B3|Baseline|Total|Total of all reporting groups
109713|NCT01937260|B2|Baseline|Cohort 2|Brodalumab 140mg SC (Day1)
109722|NCT01937195|B1|Baseline|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
109723|NCT01937195|P1|Participant Flow|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
109724|NCT01937195|O1|Outcome|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
109725|NCT01937195|O1|Outcome|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
109726|NCT01937195|O1|Outcome|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
109727|NCT01937195|O1|Outcome|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
109728|NCT01937195|O1|Outcome|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
109729|NCT01937195|O1|Outcome|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
109730|NCT01937195|O1|Outcome|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
109731|NCT01937195|E1|Reported Event|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
109732|NCT01937130|B5|Baseline|Total|Total of all reporting groups
109733|NCT01937130|B4|Baseline|Placebo|"Dosed twice daily~Placebo"
109734|NCT01937130|B3|Baseline|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
109735|NCT01937130|B2|Baseline|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
109736|NCT01937130|B1|Baseline|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
109737|NCT01937130|P4|Participant Flow|Placebo|"Dosed twice daily~Placebo"
109738|NCT01937130|P3|Participant Flow|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
109739|NCT01937130|P2|Participant Flow|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
109740|NCT01937130|P1|Participant Flow|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
109741|NCT01937130|O4|Outcome|Placebo|"Dosed twice daily~Placebo"
109742|NCT01937130|O3|Outcome|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
109743|NCT01937130|O2|Outcome|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
109744|NCT01937130|O1|Outcome|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
109745|NCT01937130|O4|Outcome|Placebo|"Dosed twice daily~Placebo"
109746|NCT01937130|O3|Outcome|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
109747|NCT01937130|O2|Outcome|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
109748|NCT01937130|O1|Outcome|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
109749|NCT01937130|O4|Outcome|Placebo|"Dosed twice daily~Placebo"
109750|NCT01937130|O3|Outcome|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
109751|NCT01937130|O2|Outcome|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
109752|NCT01937130|O1|Outcome|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
109753|NCT01937130|O3|Outcome|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
109754|NCT01937130|O2|Outcome|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
109755|NCT01937130|O1|Outcome|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
109756|NCT01937130|O3|Outcome|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
109757|NCT01937130|O2|Outcome|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
109758|NCT01937130|O1|Outcome|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
109759|NCT01937130|O3|Outcome|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
109760|NCT01937130|O2|Outcome|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
109761|NCT01937130|O1|Outcome|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
109762|NCT01937130|E4|Reported Event|Placebo|"Dosed twice daily~Placebo"
109763|NCT01937130|E3|Reported Event|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
109764|NCT01937130|E2|Reported Event|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
109765|NCT01937130|E1|Reported Event|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
109766|NCT01937026|B1|Baseline|Baricitinib|"4 mg baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 5 in Period 2.~1000 mg probenecid tablet administered orally, BID, on Days 3 through 7 in Period 2."
109767|NCT01937026|P1|Participant Flow|Baricitinib|"4 milligram (mg) baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 5 in Period 2.~1000 mg probenecid tablet administered orally, twice daily (BID), on Days 3 through 7 in Period 2."
109768|NCT01937026|O2|Outcome|Baricitinib + Probenecid|"4 mg baricitinib tablet administered orally, once, on Day 5 in Period 2.~1000 mg probenecid tablet administered orally, BID, on Days 3 through 7 in Period 2."
109770|NCT01937026|O2|Outcome|Baricitinib + Probenecid|"4 mg baricitinib tablet administered orally, once, on Day 5 in Period 2.~1000 mg probenecid tablet administered orally, BID, on Days 3 through 7 in Period 2."
109771|NCT01937026|O1|Outcome|Baricitinib|4 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.
109772|NCT01937026|E3|Reported Event|Baricitinib + Probenecid|"4 mg baricitinib tablet administered orally, once, on Day 5 in Period 2.~1000 mg probenecid tablet administered orally, BID, on Days 5 through 7 in Period 2.~Adverse events are reported from postdose on Day 5 up to Day 18."
109773|NCT01937026|E2|Reported Event|Probenecid|"1000 mg probenecid tablet administered orally, BID, on Days 3 through 4 in Period 2.~Adverse events are reported from postdose on Day 3 through predose on Day 5."
109774|NCT01937026|E1|Reported Event|Baricitinib|"4 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.~Adverse events are reported from baseline through predose on Day 3."
109775|NCT01936974|B3|Baseline|Total|Total of all reporting groups
109776|NCT01936974|B2|Baseline|Gemcitabine and Bevacizumab|"Gemcitabine on days 1 and 8~Bevacizumab on day 1~Gemcitabine~Bevacizumab"
109777|NCT01936974|B1|Baseline|Platinum, Gemcitabine and Bevacizumab|"Platinum:~Carboplatin* on day 1~*If a patient is allergic to carboplatin, then give~Cisplatin** on day 1~**If a patient is allergic to cisplatin and carboplatin, then give~Oxaliplatin on day 1~Gemcitabine on day 1 only~Bevacizumab on day 1~Gemcitabine~Bevacizumab~Carboplatin~Cisplatin~Oxaliplatin"
109778|NCT01936974|P2|Participant Flow|Gemcitabine and Bevacizumab|"Gemcitabine on days 1 and 8~Bevacizumab on day 1~Gemcitabine~Bevacizumab"
109779|NCT01936974|P1|Participant Flow|Platinum, Gemcitabine and Bevacizumab|"Platinum:~Carboplatin* on day 1~*If a patient is allergic to carboplatin, then give~Cisplatin** on day 1~**If a patient is allergic to cisplatin and carboplatin, then give~Oxaliplatin on day 1~Gemcitabine on day 1 only~Bevacizumab on day 1~Gemcitabine~Bevacizumab~Carboplatin~Cisplatin~Oxaliplatin"
109780|NCT01936974|O2|Outcome|Gemcitabine and Bevacizumab|"Gemcitabine on days 1 and 8~Bevacizumab on day 1~Gemcitabine~Bevacizumab"
109781|NCT01936974|O1|Outcome|Platinum, Gemcitabine and Bevacizumab|"Platinum:~Carboplatin* on day 1~*If a patient is allergic to carboplatin, then give~Cisplatin** on day 1~**If a patient is allergic to cisplatin and carboplatin, then give~Oxaliplatin on day 1~Gemcitabine on day 1 only~Bevacizumab on day 1~Gemcitabine~Bevacizumab~Carboplatin~Cisplatin~Oxaliplatin"
109782|NCT01936974|E2|Reported Event|Gemcitabine and Bevacizumab|"Gemcitabine on days 1 and 8~Bevacizumab on day 1~Gemcitabine~Bevacizumab"
109783|NCT01936974|E1|Reported Event|Platinum, Gemcitabine and Bevacizumab|"Platinum:~Carboplatin* on day 1~*If a patient is allergic to carboplatin, then give~Cisplatin** on day 1~**If a patient is allergic to cisplatin and carboplatin, then give~Oxaliplatin on day 1~Gemcitabine on day 1 only~Bevacizumab on day 1~Gemcitabine~Bevacizumab~Carboplatin~Cisplatin~Oxaliplatin"
109784|NCT01936909|B4|Baseline|Total|Total of all reporting groups
109785|NCT01936909|B3|Baseline|Placebo|"Placebo injections daily for 12 weeks~Placebo"
109786|NCT01936909|B2|Baseline|Anakinra (Long)|"Anakinra 100 mg daily for 12 weeks~Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2~Anakinra (weeks 3-12)"
109787|NCT01936909|B1|Baseline|Anakinra (Short)|"Anakinra 100 mg daily for 2 weeks, followed by placebo for 10 weeks~Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2"
109788|NCT01936909|P3|Participant Flow|Placebo|"Placebo injections daily for 12 weeks~Placebo"
109789|NCT01936909|P2|Participant Flow|Anakinra (Long)|"Anakinra 100 mg daily for 12 weeks~Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2~Anakinra (weeks 3-12)"
109790|NCT01936909|P1|Participant Flow|Anakinra (Short)|"Anakinra 100 mg daily for 2 weeks, followed by placebo for 10 weeks~Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2"
109791|NCT01936909|O3|Outcome|Placebo|"Placebo injections daily for 12 weeks~Placebo"
109792|NCT01936909|O2|Outcome|Anakinra (Long)|"Anakinra 100 mg daily for 12 weeks~Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2~Anakinra (weeks 3-12)"
109793|NCT01936909|O1|Outcome|Anakinra (Short)|"Anakinra 100 mg daily for 2 weeks, followed by placebo for 10 weeks~Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2"
109794|NCT01936909|O3|Outcome|Placebo|"Placebo injections daily for 12 weeks~Placebo"
109795|NCT01936909|O2|Outcome|Anakinra (Long)|"Anakinra 100 mg daily for 12 weeks~Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2~Anakinra (weeks 3-12)"
109796|NCT01936909|O1|Outcome|Anakinra (Short)|"Anakinra 100 mg daily for 2 weeks, followed by placebo for 10 weeks~Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2"
109797|NCT01936909|O3|Outcome|Placebo|"Placebo injections daily for 12 weeks~Placebo"
109798|NCT01936909|O2|Outcome|Anakinra (Long)|"Anakinra 100 mg daily for 12 weeks~Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2~Anakinra (weeks 3-12)"
109799|NCT01936909|O1|Outcome|Anakinra (Short)|"Anakinra 100 mg daily for 2 weeks, followed by placebo for 10 weeks~Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2"
109800|NCT01936909|E3|Reported Event|Placebo|"Placebo injections daily for 12 weeks~Placebo"
109801|NCT01936909|E2|Reported Event|Anakinra (Long)|"Anakinra 100 mg daily for 12 weeks~Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2~Anakinra (weeks 3-12)"
109802|NCT01936909|E1|Reported Event|Anakinra (Short)|"Anakinra 100 mg daily for 2 weeks, followed by placebo for 10 weeks~Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2"
109803|NCT01936896|B1|Baseline|Alpha-1 Anti-trypsin (AAT)|Plasma derived (Alpha 1-Antitrypsin) AAT 60 mg/Kg, single infusion, within 12 hours of hospital admission for ST-segment elevation myocardial infarction (STEMI)
109804|NCT01936896|P1|Participant Flow|Alpha-1 Anti-trypsin (AAT)|Plasma derived Alpha 1-Antitrypsin (AAT) 60 mg/Kg, single infusion, within 12 hours of hospital admission for ST-segment elevation myocardial infarction (STEMI)
109805|NCT01936896|O1|Outcome|Alpha-1 Anti-trypsin (AAT)|Plasma derived AAT 60 mg/Kg, single infusion
109806|NCT01936896|O1|Outcome|Alpha-1 Anti-trypsin (AAT)|Plasma derived AAT 60 mg/Kg, single infusion
109807|NCT01936896|E1|Reported Event|Alpha-1 Anti-trypsin (AAT)|Plasma derived AAT 60 mg/Kg, single infusion
109808|NCT01936870|B1|Baseline|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
109809|NCT01936870|P1|Participant Flow|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
109810|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
109811|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
109812|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
109813|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
109814|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
109815|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
109816|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
109817|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
109818|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
109819|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
109820|NCT01936870|E1|Reported Event|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
109821|NCT01936844|B3|Baseline|Total|Total of all reporting groups
109822|NCT01936844|B2|Baseline|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.~Placebo: Placebo twice daily for days 1, 2, and 3~Placebo: Placebo daily for days 4-14"
109823|NCT01936844|B1|Baseline|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14~Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3~Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
109824|NCT01936844|P2|Participant Flow|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.~Placebo: Placebo twice daily for days 1, 2, and 3~Placebo: Placebo daily for days 4-14"
109825|NCT01936844|P1|Participant Flow|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14~Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3~Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
109826|NCT01936844|O2|Outcome|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.~Placebo: Placebo twice daily for days 1, 2, and 3~Placebo: Placebo daily for days 4-14"
109827|NCT01936844|O1|Outcome|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14~Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3~Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
109828|NCT01936844|O2|Outcome|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.~Placebo: Placebo twice daily for days 1, 2, and 3~Placebo: Placebo daily for days 4-14"
109829|NCT01936844|O1|Outcome|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14~Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3~Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
109830|NCT01936844|O2|Outcome|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.~Placebo: Placebo twice daily for days 1, 2, and 3~Placebo: Placebo daily for days 4-14"
109831|NCT01936844|O1|Outcome|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14~Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3~Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
109832|NCT01936844|E2|Reported Event|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.~Placebo: Placebo twice daily for days 1, 2, and 3~Placebo: Placebo daily for days 4-14"
109833|NCT01936844|E1|Reported Event|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14~Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3~Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
109834|NCT01936662|B3|Baseline|Total|Total of all reporting groups
109835|NCT01936662|B2|Baseline|ETT Used to Maintain Airway|Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital
109836|NCT01936662|B1|Baseline|LMA Used to Maintain Airway|Patients randomized to LMA to maintain airway through EGD procedure
109837|NCT01936662|P2|Participant Flow|ETT Used to Maintain Airway|Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital
109838|NCT01936662|P1|Participant Flow|LMA Used to Maintain Airway|Patients randomized to LMA to maintain airway through EGD procedure
109839|NCT01936662|O2|Outcome|ETT Used to Maintain Airway|Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital
109840|NCT01936662|O1|Outcome|LMA Used to Maintain Airway|Patients randomized to LMA to maintain airway through EGD procedure
109841|NCT01936662|O2|Outcome|Endotracheal Tube for EGD Procedure|"Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital~ETT: Patients assigned to this group had an ETT placed to maintain their airway, as is standard of care at this hospital"
109842|NCT01936662|O1|Outcome|Largyngeal Mask Airway for EGD Procedure|"Patients randomized to LMA to maintain airway through EGD procedure~LMA: Patients randomized to the LMA group had their airways maintained with a LMA device"
110484|NCT01933243|O1|Outcome|PUFA|Participants randomized to omega-3 PUFA
109843|NCT01936662|E2|Reported Event|ETT Used to Maintain Airway|Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital
109844|NCT01936662|E1|Reported Event|LMA Used to Maintain Airway|Patients randomized to LMA to maintain airway through EGD procedure
109845|NCT01936649|B1|Baseline|AdreView (Iobenguane I 123 Injection)|Two administrations of single i.v. injection of Iobenguane I 123 10 mCi (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days.
109846|NCT01936649|P1|Participant Flow|AdreView (Iobenguane I 123 Injection)|Two administrations of single intravenous (i.v.) injection of Iobenguane I 123 10 millicuries (mCi) (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days.
109847|NCT01936649|O1|Outcome|AdreView (Iobenguane I 123 Injection)|Two administrations of single i.v. injection of Iobenguane I 123 10 mCi (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days.
109848|NCT01936649|O1|Outcome|AdreView (Iobenguane I 123 Injection)|Two administrations of single i.v. injection of Iobenguane I 123 10 mCi (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days.
109849|NCT01936649|E1|Reported Event|AdreView (Iobenguane I 123 Injection)|Two administrations of single i.v. injection of Iobenguane I 123 10 mCi (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days.
109850|NCT01936623|B3|Baseline|Total|Total of all reporting groups
109851|NCT01936623|B2|Baseline|Delayed Computerized Brief Intervention|"Participants receive only a substance abuse assessment at baseline. At three-month follow-up, they then receive the computerized brief intervention.~Computerized Brief Intervention: No additional information needed."
109852|NCT01936623|B1|Baseline|Computerized Brief Intervention|"Computerized Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use.~Computerized Brief Intervention: No additional information needed."
109853|NCT01936623|P2|Participant Flow|Delayed Computerized Brief Intervention|"Participants receive only a substance abuse assessment at baseline. At three-month follow-up, they then receive the computerized brief intervention.~Computerized Brief Intervention: No additional information needed."
109854|NCT01936623|P1|Participant Flow|Computerized Brief Intervention|"Computerized Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use.~Computerized Brief Intervention: No additional information needed."
109855|NCT01936623|O2|Outcome|Delayed Computerized Brief Intervention|"Participants receive only a substance abuse assessment at baseline. At three-month follow-up, they then receive the computerized brief intervention.~Computerized Brief Intervention: No additional information needed."
109856|NCT01936623|O1|Outcome|Computerized Brief Intervention|"Computerized Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use.~Computerized Brief Intervention: No additional information needed."
109857|NCT01936623|O2|Outcome|Delayed Computerized Brief Intervention|"Participants receive only a substance abuse assessment at baseline. At three-month follow-up, they then receive the computerized brief intervention.~Computerized Brief Intervention: No additional information needed."
109858|NCT01936623|O1|Outcome|Computerized Brief Intervention|"Computerized Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use.~Computerized Brief Intervention: No additional information needed."
109859|NCT01936623|O2|Outcome|Delayed Computerized Brief Intervention|"Participants receive only a substance abuse assessment at baseline. At three-month follow-up, they then receive the computerized brief intervention.~Computerized Brief Intervention: No additional information needed."
109860|NCT01936623|O1|Outcome|Computerized Brief Intervention|"Computerized Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use.~Computerized Brief Intervention: No additional information needed."
109861|NCT01936623|O2|Outcome|Delayed Computerized Brief Intervention|"Participants receive only a substance abuse assessment at baseline. At three-month follow-up, they then receive the computerized brief intervention.~Computerized Brief Intervention: No additional information needed."
109862|NCT01936623|O1|Outcome|Computerized Brief Intervention|"Computerized Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use.~Computerized Brief Intervention: No additional information needed."
109863|NCT01936623|E2|Reported Event|Delayed Computerized Brief Intervention|"Participants receive only a substance abuse assessment at baseline. At three-month follow-up, they then receive the computerized brief intervention.~Computerized Brief Intervention: No additional information needed."
109864|NCT01936623|E1|Reported Event|Computerized Brief Intervention|"Computerized Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use.~Computerized Brief Intervention: No additional information needed."
109865|NCT01936467|B3|Baseline|Total|Total of all reporting groups
109866|NCT01936467|B2|Baseline|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.~Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
109867|NCT01936467|B1|Baseline|Suction Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.~Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
109906|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
109868|NCT01936467|P2|Participant Flow|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.~Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
109869|NCT01936467|P1|Participant Flow|Suction Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.~Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
109870|NCT01936467|O2|Outcome|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.~Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
109871|NCT01936467|O1|Outcome|Suction Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.~Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
109872|NCT01936467|O2|Outcome|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.~Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
109873|NCT01936467|O1|Outcome|Suction Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.~Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
109874|NCT01936467|O2|Outcome|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.~Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
109875|NCT01936467|O1|Outcome|Suction Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.~Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
109876|NCT01936467|O2|Outcome|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.~Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
109877|NCT01936467|O1|Outcome|Suction Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.~Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
109878|NCT01936467|O2|Outcome|Patients With Negative Gold Standard|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.~Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
109879|NCT01936467|O1|Outcome|Patients With Positive Gold Standard|gold standard is defined as follows: for resectable cases, surgical histology was considered the gold standard. For unresectable or benign cases, positive cytology (with compatible clinical outcome) at 6-month follow-up was considered gold standard. Negative cytology was confirmed with clinical data and/or imaging at 6 month follow-up.
109880|NCT01936467|O2|Outcome|Patients With Negative Gold Standard|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.~Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
109881|NCT01936467|O1|Outcome|Patients With Positive Gold Standard|gold standard is defined as follows: for resectable cases, surgical histology was considered the gold standard. For unresectable or benign cases, positive cytology (with compatible clinical outcome) at 6-month follow-up was considered gold standard. Negative cytology was confirmed with clinical data and/or imaging at 6 month follow-up.
109882|NCT01936467|O1|Outcome|Standard Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.~Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
109883|NCT01936467|O1|Outcome|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.~Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
109884|NCT01936467|E2|Reported Event|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.~Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
109885|NCT01936467|E1|Reported Event|Suction Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.~Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
109886|NCT01936389|B3|Baseline|Total|Total of all reporting groups
109887|NCT01936389|B2|Baseline|0.7%|"0.7% Rho-Kinase Inhibitor~AR-12286"
109888|NCT01936389|B1|Baseline|0.5%|"0.5% Rho-Kinase Inhibitor~AR-12286"
109889|NCT01936389|P2|Participant Flow|0.7%|"0.7% Rho-Kinase Inhibitor~AR-12286"
109890|NCT01936389|P1|Participant Flow|0.5%|"0.5% Rho-Kinase Inhibitor~AR-12286"
109891|NCT01936389|O2|Outcome|0.7%|"0.7% Rho-Kinase Inhibitor~AR-12286"
109892|NCT01936389|O1|Outcome|0.5%|"0.5% Rho-Kinase Inhibitor~AR-12286"
109893|NCT01936389|E2|Reported Event|0.7%|"0.7% Rho-Kinase Inhibitor~AR-12286"
109894|NCT01936389|E1|Reported Event|0.5%|"0.5% Rho-Kinase Inhibitor~AR-12286"
109895|NCT01936363|B3|Baseline|Total|Total of all reporting groups
109896|NCT01936363|B2|Baseline|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
109897|NCT01936363|B1|Baseline|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
109898|NCT01936363|P2|Participant Flow|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
109899|NCT01936363|P1|Participant Flow|Pimasertib (Once Daily) Plus SAR245409|Subjects received Pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
109900|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
109901|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
109902|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
109903|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
109904|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
109905|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received Pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
109978|NCT01934894|O1|Outcome|Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 20 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
109907|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
109908|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
109909|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
109910|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
109911|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
109912|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
109913|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
109914|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
109915|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
109916|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
109917|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
109918|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
109919|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
109920|NCT01936363|E2|Reported Event|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
109921|NCT01936363|E1|Reported Event|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
109922|NCT01936181|B3|Baseline|Total|Total of all reporting groups
109923|NCT01936181|B2|Baseline|Remicade (Infliximab)|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46~At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70."
109924|NCT01936181|B1|Baseline|SB2 (Proposed Biosimilar to Inflixmab)|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70~SB2 (proposed biosimilar to infliximab)"
109925|NCT01936181|P4|Participant Flow|Remicade (Infliximab), Continue as Remicade|"Remicade 3mg/kg at week 54, 62, 70~Remicade (infliximab)"
109926|NCT01936181|P3|Participant Flow|Remicade (Infliximab), Switch to SB2|"SB2 3mg/kg at week 54, 62, 70~SB2 (proposed biosimilar to infliximab)"
109927|NCT01936181|P2|Participant Flow|Remicade (Infliximab)|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46~At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70."
109928|NCT01936181|P1|Participant Flow|SB2 (Proposed Biosimilar to Inflixmab)|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70~SB2 (proposed biosimilar to infliximab)"
109929|NCT01936181|O5|Outcome|Remicade (Infliximab), Continue as Remicade|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46~At Week 54, subjects were randomised to continue on Remicade (Remicade/Remicade) up to Week 70 and received Remicade 3mg/kg at week 54, 62, 70."
109979|NCT01934894|O2|Outcome|Dose Level 2 (25 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 25 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
110485|NCT01933243|O2|Outcome|Placebo|Participants randomized to placebo
109930|NCT01936181|O4|Outcome|Remicade (Infliximab), Switch to SB2 at Week 78|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46~At Week 54, subjects were randomised to be transitioned to SB2 (Remicade/SB2) up to Week 70 and received SB2 3mg/kg at week 54, 62, 70.~SB2 (proposed biosimilar to infliximab)"
109931|NCT01936181|O3|Outcome|SB2 at Week 78|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70~SB2 (proposed biosimilar to infliximab)"
109932|NCT01936181|O2|Outcome|Remicade (Infliximab) at Week 54|Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46
109933|NCT01936181|O1|Outcome|SB2 at Week 54|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70~SB2 (proposed biosimilar to infliximab)"
109934|NCT01936181|O2|Outcome|Remicade (Infliximab)|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46~At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70."
109935|NCT01936181|O1|Outcome|SB2 (Proposed Biosimilar to Inflixmab)|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70~SB2 (proposed biosimilar to infliximab)"
109936|NCT01936181|E2|Reported Event|Remicade (Infliximab)|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46~At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70."
109937|NCT01936181|E1|Reported Event|SB2 (Proposed Biosimilar to Inflixmab)|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70~SB2 (proposed biosimilar to infliximab)"
109938|NCT01935622|B4|Baseline|Total|Total of all reporting groups
109939|NCT01935622|B3|Baseline|Placebo|"Placebo~placebo"
109940|NCT01935622|B2|Baseline|Doxycycline 20 mg|"Doxycycline 20 mg twice daily for 14 days~Doxycycline"
109941|NCT01935622|B1|Baseline|Doxycycline 100 mg|"Doxycycline 100 mg twice daily for 14 days~Doxycycline"
109942|NCT01935622|P3|Participant Flow|Placebo|"Placebo~placebo"
109943|NCT01935622|P2|Participant Flow|Doxycycline 20 mg|"Doxycycline 20 mg twice daily for 14 days~Doxycycline"
109944|NCT01935622|P1|Participant Flow|Doxycycline 100 mg|"Doxycycline 100 mg twice daily for 14 days~Doxycycline"
109945|NCT01935622|O3|Outcome|Placebo|"Placebo~placebo"
109946|NCT01935622|O2|Outcome|Doxycycline 20 mg|"Doxycycline 20 mg twice daily for 14 days~Doxycycline"
109947|NCT01935622|O1|Outcome|Doxycycline 100 mg|"Doxycycline 100 mg twice daily for 14 days~Doxycycline"
109948|NCT01935622|E3|Reported Event|Placebo|"Placebo~placebo"
109949|NCT01935622|E2|Reported Event|Doxycycline 20 mg|"Doxycycline 20 mg twice daily for 14 days~Doxycycline"
109950|NCT01935622|E1|Reported Event|Doxycycline 100 mg|"Doxycycline 100 mg twice daily for 14 days~Doxycycline"
109951|NCT01935180|B3|Baseline|Total|Total of all reporting groups
109952|NCT01935180|B2|Baseline|Cap Assisted Colonoscopy|"A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.~Colonoscopy Cap: 4mm transparent cap (Olympus) mounted to the tip of a colonoscope."
109953|NCT01935180|B1|Baseline|Standard Colonoscopy|Standard colonoscopy without an attachment cap
109954|NCT01935180|P2|Participant Flow|Cap Assisted Colonoscopy|"A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.~Colonoscopy Cap: 4mm transparent cap (Olympus) mounted to the tip of a colonoscope."
109955|NCT01935180|P1|Participant Flow|Standard Colonoscopy|Standard colonoscopy without an attachment cap
109956|NCT01935180|O2|Outcome|Cap Assisted Colonoscopy|A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
109957|NCT01935180|O1|Outcome|Standard Colonoscopy|Colonoscopy without a cap.
109958|NCT01935180|O2|Outcome|Cap Assisted Colonoscopy|A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
109959|NCT01935180|O1|Outcome|Standard Colonoscopy|Colonoscopy without a cap.
109960|NCT01935180|O2|Outcome|Cap Assisted Colonoscopy|A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
109961|NCT01935180|O1|Outcome|Standard Colonoscopy|Colonoscopy without a cap.
109962|NCT01935180|O2|Outcome|Cap Assisted Colonoscopy|A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
109963|NCT01935180|O1|Outcome|Standard Colonoscopy|Colonoscopy without a cap.
109964|NCT01935180|O2|Outcome|Cap Assisted Colonoscopy|A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
109965|NCT01935180|O1|Outcome|Standard Colonoscopy|Colonoscopy without a cap.
109966|NCT01935180|O2|Outcome|Cap Assisted Colonoscopy|A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
109967|NCT01935180|O1|Outcome|Standard Colonoscopy|Colonoscopy without a cap.
109968|NCT01935180|O2|Outcome|Cap Assisted Colonoscopy|A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
109969|NCT01935180|O1|Outcome|Standard Colonoscopy|Colonoscopy without a cap.
109970|NCT01935180|E2|Reported Event|Cap Assisted Colonoscopy|A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
109971|NCT01935180|E1|Reported Event|Standard Colonoscopy|Colonoscopy without a cap.
109972|NCT01934894|B3|Baseline|Total|Total of all reporting groups
109973|NCT01934894|B2|Baseline|Dose Level 2 (Level 1 (25 mg/m2 Cabazitaxel + Lapatinib)|Cabazitaxel: 25 mg/m2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
109974|NCT01934894|B1|Baseline|Dose Level 1 (20 mg/m2 Cabazitaxel + Lapatinib)|Cabazitaxel: 20 mg/m2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
109975|NCT01934894|P2|Participant Flow|Dose Level 2 (Level 1 (25 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 25 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
109976|NCT01934894|P1|Participant Flow|Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 20 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
109977|NCT01934894|O2|Outcome|Dose Level 2 (25 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 25 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
109980|NCT01934894|O1|Outcome|Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 20 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
109981|NCT01934894|O2|Outcome|Dose Level 2 (25 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 25 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
109982|NCT01934894|O1|Outcome|Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 20 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
109983|NCT01934894|O2|Outcome|Dose Level 2|Cabazitaxel 25mg/m^2:: 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
109984|NCT01934894|O1|Outcome|Dose Level 1|Cabazitaxel: 20 mg/m^2: 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
109985|NCT01934894|O1|Outcome|Cabazitaxel and Lapatinib|Cabazitaxel: (at Dose Level 1, 20 mg/m^2 or at Dose Level 2, 25 mg/m^2), 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
109986|NCT01934894|O2|Outcome|Dose Level 2 (25 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 25 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
109987|NCT01934894|O1|Outcome|Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 20 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
109988|NCT01934894|E2|Reported Event|Dose Level 2 (25 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 25 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
109989|NCT01934894|E1|Reported Event|Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 20 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
109990|NCT01934790|B1|Baseline|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
109991|NCT01934790|P1|Participant Flow|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
109992|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
109993|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
109994|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
109995|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
109996|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
109997|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
109998|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
109999|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
110000|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
110001|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
110002|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
110003|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
110004|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
110005|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
110006|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
110007|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
110008|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
110009|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
110010|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
110011|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
110012|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
110013|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
110014|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
110015|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
110016|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
110017|NCT01934790|E1|Reported Event|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections
110018|NCT01934582|B1|Baseline|Open-label Extension PK Population|The PK population included all subjects enrolled in the PK substudy having met the study criteria, who had sufficient treprostinil concentration-time data to derive noncompartmental PK parameters for at least 1 treatment of open-label treprostinil diethanolamine.
110019|NCT01934582|P1|Participant Flow|Open-label Extension PK Population|The PK population included all subjects enrolled in the PK substudy having met the study criteria who received at least 1 treatment of open-label treprostinil diethanolamine.
110020|NCT01934582|O2|Outcome|PK Visit 2|UT-15C SR (treprostinil diethanolamine) TID
110021|NCT01934582|O1|Outcome|PK Visit 1|UT-15C SR (treprostinil diethanolamine) BID
110022|NCT01934582|O2|Outcome|PK Visit 2|UT-15C SR (treprostinil diethanolamine) TID
110023|NCT01934582|O1|Outcome|PK Visit 1|UT-15C SR (treprostinil diethanolamine) BID
110024|NCT01934582|O2|Outcome|PK Visit 2|UT-15C SR (treprostinil diethanolamine) TID
110025|NCT01934582|O1|Outcome|PK Visit 1|UT-15C SR (treprostinil diethanolamine) BID
110026|NCT01934582|O2|Outcome|PK Visit 2|UT-15C SR (treprostinil diethanolamine) TID
110027|NCT01934582|O1|Outcome|PK Visit 1|UT-15C SR (treprostinil diethanolamine) BID
110028|NCT01934582|O2|Outcome|PK Visit 2|UT-15C SR (treprostinil diethanolamine) TID
110029|NCT01934582|O1|Outcome|PK Visit 1|UT-15C SR (treprostinil diethanolamine) BID
110030|NCT01934582|E2|Reported Event|PK Visit 2|UT-15C SR (treprostinil diethanolamine): open-label study drug
110031|NCT01934582|E1|Reported Event|PK Visit 1|UT-15C SR (treprostinil diethanolamine): open-label study drug
110032|NCT01934517|B1|Baseline|iTero, Lava Digital and Plaster Models|All study participants: iTero, LavaDigital and plaster models (single-group study)
110033|NCT01934517|P1|Participant Flow|iTero, Lava Digital and Plaster Models: All Study Participants|"Single-group study:~ITero models obtained from intraoral scans with iTero scanner~Plaster models obtained from alginate and PVS intraoral impressionsScan of plaster~Lava Digital models obtained from extraoral scans of plaster models"
110034|NCT01934517|O3|Outcome|Lava Digital Models|Lava Digital models obtained from extraoral scans of plaster models
110035|NCT01934517|O2|Outcome|Plaster Models|Plaster models obtained from alginate and PVS intraoral impressionsScan of plaster
110036|NCT01934517|O1|Outcome|iTero Models|ITero models obtained from intraoral scans with iTero scanner
110037|NCT01934517|E3|Reported Event|Lava Digital Models|Lava Digital models obtained from extraoral scans of plaster models
110038|NCT01934517|E2|Reported Event|Plaster Models|Plaster models obtained from alginate and PVS intraoral impressionsScan of plaster
110039|NCT01934517|E1|Reported Event|iTero Models|ITero models obtained from intraoral scans with iTero scanner
110040|NCT01934504|B5|Baseline|Total|Total of all reporting groups
110041|NCT01934504|B4|Baseline|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
110042|NCT01934504|B3|Baseline|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
110043|NCT01934504|B2|Baseline|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
110044|NCT01934504|B1|Baseline|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
110045|NCT01934504|P4|Participant Flow|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
110046|NCT01934504|P3|Participant Flow|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
110047|NCT01934504|P2|Participant Flow|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
110122|NCT01934192|O1|Outcome|Camicinal 50 mg|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
110123|NCT01934192|O2|Outcome|Placebo|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
110048|NCT01934504|P1|Participant Flow|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
110049|NCT01934504|O4|Outcome|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
110050|NCT01934504|O3|Outcome|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
110051|NCT01934504|O2|Outcome|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
110052|NCT01934504|O1|Outcome|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
110053|NCT01934504|O4|Outcome|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
110054|NCT01934504|O3|Outcome|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
110055|NCT01934504|O2|Outcome|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
110056|NCT01934504|O1|Outcome|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
110057|NCT01934504|O4|Outcome|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
110058|NCT01934504|O3|Outcome|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
110059|NCT01934504|O2|Outcome|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
110060|NCT01934504|O1|Outcome|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
110061|NCT01934504|O4|Outcome|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
110062|NCT01934504|O3|Outcome|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
110063|NCT01934504|O2|Outcome|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
110064|NCT01934504|O1|Outcome|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
110065|NCT01934504|E4|Reported Event|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
110066|NCT01934504|E3|Reported Event|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
110067|NCT01934504|E2|Reported Event|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
110068|NCT01934504|E1|Reported Event|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
110069|NCT01934231|B1|Baseline|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
110070|NCT01934231|P1|Participant Flow|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
110071|NCT01934231|O1|Outcome|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
110072|NCT01934231|O1|Outcome|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
110073|NCT01934231|O1|Outcome|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
110074|NCT01934231|O1|Outcome|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
110075|NCT01934231|O1|Outcome|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
110076|NCT01934231|O1|Outcome|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
110077|NCT01934231|E1|Reported Event|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
110078|NCT01934218|B3|Baseline|Total|Total of all reporting groups
110079|NCT01934218|B2|Baseline|Placebo|The participants received a single intra-articular injection of PBS.
110080|NCT01934218|B1|Baseline|Gel-One|The participants received a single intra-articular injection of Gel-One.
110081|NCT01934218|P2|Participant Flow|Placebo|The participants received a single intra-articular injection of Phosphate Buffered Saline (PBS).
110082|NCT01934218|P1|Participant Flow|Gel-One|The participants received a single intra-articular injection of Gel-One.
110083|NCT01934218|O1|Outcome|Gel-One|The participants received a single intra-articular injection of Gel-One.
110084|NCT01934218|O2|Outcome|Placebo|The participants received a single intra-articular injection of PBS.
110085|NCT01934218|O1|Outcome|Gel-One|The participants received a single intra-articular injection of Gel-One.
110086|NCT01934218|E2|Reported Event|Placebo|3 mL, a single intra-articular injection of PBS.
110087|NCT01934218|E1|Reported Event|Gel-One|3 mL, a single intra-articular injection of Gel-One.
110088|NCT01934192|B5|Baseline|Total|Total of all reporting groups
110089|NCT01934192|B4|Baseline|Baseline EN Intolerant: Metoclopramide|Participant who were intolerant to EN feeding at Baseline were randomized to receive metoclopramide 10 mg every 6 Hrs. via IV route along with placebo drug every 6 hrs via NG tube.
110090|NCT01934192|B3|Baseline|Baseline EN Intolerant: Camicinal|Participants who were intolerant to EN feeding at Baseline were randomized to receive Camicinal (GSK962040) 50 mg once daily via NG tube along with placebo drug every 6 hrs via IV route.
110486|NCT01933243|O1|Outcome|PUFA|Participants randomized to omega-3 PUFA
110091|NCT01934192|B2|Baseline|Baseline EN Tolerant: Camicinal/Metoclopramide|Participants who were tolerant to EN feeding at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route along with placebo drug every 6 hrs via NG route.
110092|NCT01934192|B1|Baseline|Baseline EN Tolerant: Placebo/Camicinal|Participants who were tolerant to EN feeding at Baseline were randomized to receive up to 7 doses of placebo drug once daily via Naso-orogastric (NG) tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 milligram (mg) once daily along with placebo drug every 6 hours (hrs) via Intravenous (IV) route.
110093|NCT01934192|P4|Participant Flow|Baseline EN Intolerant: Metoclopramide|Participant who were intolerant to EN feeding at Baseline were randomized to receive metoclopramide 10 mg every 6 Hrs. via IV route along with placebo drug every 6 hrs via NG tube.
110094|NCT01934192|P3|Participant Flow|Baseline EN Intolerant: Camicinal|Participants who were intolerant to EN feeding at Baseline were randomized to receive Camicinal (GSK962040) 50 mg once daily via NG tube along with placebo drug every 6 hrs via IV route.
110095|NCT01934192|P2|Participant Flow|Baseline EN Tolerant: Camicinal/Metoclopramide|Participants who were tolerant to EN feeding at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route along with placebo drug every 6 hrs via NG route.
110096|NCT01934192|P1|Participant Flow|Baseline EN Tolerant: Placebo/Camicinal|Participants who were tolerant to EN feeding at Baseline were randomized to receive up to 7 doses of placebo drug once daily via Naso-orogastric (NG) tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 milligram (mg) once daily along with placebo drug every 6 hours (hrs) via Intravenous (IV) route.
110097|NCT01934192|O1|Outcome|Camicinal 50 mg|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
110098|NCT01934192|O1|Outcome|Camicinal 50 mg|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
110099|NCT01934192|O1|Outcome|Camicinal 50 mg|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
110100|NCT01934192|O1|Outcome|Camicinal 50 mg|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
110101|NCT01934192|O1|Outcome|Camicinal 50 mg|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
110102|NCT01934192|O2|Outcome|Placebo|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
110103|NCT01934192|O1|Outcome|Camicinal 50 mg|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
110104|NCT01934192|O4|Outcome|No Treatment|Participant who did not receive treatment.
110105|NCT01934192|O3|Outcome|Baseline EN Intolerant: Camicinal|Participants who were intolerant to EN feeding at Baseline were randomized to receive Camicinal (GSK962040) 50 mg once daily via NG tube along with placebo drug every 6 hrs via IV route.
110106|NCT01934192|O2|Outcome|Baseline EN Tolerant: Camicinal/Metoclopramide|Participants who were tolerant to EN feeding at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route along with placebo drug every 6 hrs via NG route.
110107|NCT01934192|O1|Outcome|Baseline EN Tolerant: Placebo/Camicinal|Participants who were tolerant to EN feeding at Baseline were randomized to receive up to 7 doses of placebo drug once daily via Naso-orogastric (NG) tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 milligram (mg) once daily along with placebo drug every 6 hours (hrs) via Intravenous (IV) route.
110108|NCT01934192|O2|Outcome|Placebo|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
110109|NCT01934192|O1|Outcome|Camicinal 50 mg|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
110110|NCT01934192|O2|Outcome|Placebo|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
110111|NCT01934192|O1|Outcome|Camicinal 50 mg|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
110112|NCT01934192|O2|Outcome|Placebo|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
110113|NCT01934192|O1|Outcome|Camicinal 50 mg|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
110114|NCT01934192|O2|Outcome|Placebo|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
110115|NCT01934192|O1|Outcome|Camicinal 50 mg|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
110116|NCT01934192|O2|Outcome|Placebo|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
110117|NCT01934192|O1|Outcome|Camicinal 50 mg|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
110118|NCT01934192|O2|Outcome|Placebo|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
110119|NCT01934192|O1|Outcome|Camicinal 50 mg|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
110120|NCT01934192|O1|Outcome|Camicinal 50 mg|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
110121|NCT01934192|O2|Outcome|Placebo|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
110487|NCT01933243|O2|Outcome|Placebo|Participants randomized to placebo
110124|NCT01934192|O1|Outcome|Camicinal 50 mg|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
110125|NCT01934192|O2|Outcome|Placebo|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
110126|NCT01934192|O1|Outcome|Camicinal 50 mg|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
110127|NCT01934192|O2|Outcome|Placebo|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
110128|NCT01934192|O1|Outcome|Camicinal 50 mg|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
110129|NCT01934192|O6|Outcome|Baseline EN Intolerant: Metoclopramide 10 mg|Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
110130|NCT01934192|O5|Outcome|Baseline EN Intolerant: Camicinal 50 mg|Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
110131|NCT01934192|O4|Outcome|Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
110132|NCT01934192|O3|Outcome|Baseline EN Tolerant: Placebo/Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
110133|NCT01934192|O2|Outcome|Baseline EN Tolerant: Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
110134|NCT01934192|O1|Outcome|Baseline EN Tolerant: Placebo|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
110135|NCT01934192|O6|Outcome|Baseline EN Intolerant: Metoclopramide 10 mg|Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
110136|NCT01934192|O5|Outcome|Baseline EN Intolerant: Camicinal 50 mg|Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
110137|NCT01934192|O4|Outcome|Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
110138|NCT01934192|O3|Outcome|Baseline EN Tolerant: Placebo/Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
110139|NCT01934192|O2|Outcome|Baseline EN Tolerant: Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
110140|NCT01934192|O1|Outcome|Baseline EN Tolerant: Placebo|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
110141|NCT01934192|O6|Outcome|Baseline EN Intolerant: Metoclopramide 10 mg|Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
110142|NCT01934192|O5|Outcome|Baseline EN Intolerant: Camicinal 50 mg|Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
110143|NCT01934192|O4|Outcome|Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
110144|NCT01934192|O3|Outcome|Baseline EN Tolerant: Placebo/Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
110145|NCT01934192|O2|Outcome|Baseline EN Tolerant: Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
110146|NCT01934192|O1|Outcome|Baseline EN Tolerant: Placebo|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
110147|NCT01934192|O6|Outcome|Baseline EN Intolerant: Metoclopramide 10 mg|Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
110148|NCT01934192|O5|Outcome|Baseline EN Intolerant: Camicinal 50 mg|Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
110149|NCT01934192|O4|Outcome|Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
110150|NCT01934192|O3|Outcome|Baseline EN Tolerant: Placebo/Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
110151|NCT01934192|O2|Outcome|Baseline EN Tolerant: Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
110383|NCT01933776|O1|Outcome|ADACEL™ Vaccine Group 1|Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
110152|NCT01934192|O1|Outcome|Baseline EN Tolerant: Placebo|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
110153|NCT01934192|O6|Outcome|Baseline EN Intolerant: Metoclopramide 10 mg|Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
110154|NCT01934192|O5|Outcome|Baseline EN Intolerant: Camicinal 50 mg|Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
110155|NCT01934192|O4|Outcome|Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
110156|NCT01934192|O3|Outcome|Baseline EN Tolerant: Placebo/Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
110157|NCT01934192|O2|Outcome|Baseline EN Tolerant: Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
110158|NCT01934192|O1|Outcome|Baseline EN Tolerant: Placebo|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
110159|NCT01934192|O6|Outcome|Baseline EN Intolerant: Metoclopramide 10 mg|Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
110160|NCT01934192|O5|Outcome|Baseline EN Intolerant: Camicinal 50 mg|Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
110161|NCT01934192|O4|Outcome|Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
110162|NCT01934192|O3|Outcome|Baseline EN Tolerant: Placebo/Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
110163|NCT01934192|O2|Outcome|Baseline EN Tolerant: Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
110164|NCT01934192|O1|Outcome|Baseline EN Tolerant: Placebo|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
110165|NCT01934192|O6|Outcome|Baseline EN Intolerant: Metoclopramide 10 mg|Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
110166|NCT01934192|O5|Outcome|Baseline EN Intolerant: Camicinal 50 mg|Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
110167|NCT01934192|O4|Outcome|Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
110168|NCT01934192|O3|Outcome|Baseline EN Tolerant: Placebo/Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
110169|NCT01934192|O2|Outcome|Baseline EN Tolerant: Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
110170|NCT01934192|O1|Outcome|Baseline EN Tolerant: Placebo|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
110171|NCT01934192|O6|Outcome|Baseline EN Intolerant: Metoclopramide 10 mg|Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
110172|NCT01934192|O5|Outcome|Baseline EN Intolerant: Camicinal 50 mg|Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
110173|NCT01934192|O4|Outcome|Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
110174|NCT01934192|O3|Outcome|Baseline EN Tolerant: Placebo/Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
110175|NCT01934192|O2|Outcome|Baseline EN Tolerant: Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
110176|NCT01934192|O1|Outcome|Baseline EN Tolerant: Placebo|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
110177|NCT01934192|O6|Outcome|Baseline EN Intolerant: Metoclopramide 10 mg|Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
110178|NCT01934192|O5|Outcome|Baseline EN Intolerant: Camicinal 50 mg|Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
110384|NCT01933776|E2|Reported Event|ADACEL™ Vaccine Group 2|Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
110179|NCT01934192|O4|Outcome|Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
110180|NCT01934192|O3|Outcome|Baseline EN Tolerant: Placebo/Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
110181|NCT01934192|O2|Outcome|Baseline EN Tolerant: Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
110182|NCT01934192|O1|Outcome|Baseline EN Tolerant: Placebo|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
110183|NCT01934192|O6|Outcome|Baseline EN Intolerant: Metoclopramide 10 mg|Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
110184|NCT01934192|O5|Outcome|Baseline EN Intolerant: Camicinal 50 mg|Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
110185|NCT01934192|O4|Outcome|Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
110186|NCT01934192|O3|Outcome|Baseline EN Tolerant: Placebo/Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
110187|NCT01934192|O2|Outcome|Baseline EN Tolerant: Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
110188|NCT01934192|O1|Outcome|Baseline EN Tolerant: Placebo|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
110189|NCT01934192|O6|Outcome|Baseline EN Intolerant: Metoclopramide 10 mg|Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
110190|NCT01934192|O5|Outcome|Baseline EN Intolerant: Camicinal 50 mg|Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
110191|NCT01934192|O4|Outcome|Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
110192|NCT01934192|O3|Outcome|Baseline EN Tolerant: Placebo/Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
110193|NCT01934192|O2|Outcome|Baseline EN Tolerant: Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
110194|NCT01934192|O1|Outcome|Baseline EN Tolerant: Placebo|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
110195|NCT01934192|O6|Outcome|Baseline EN Intolerant: Metoclopramide 10 mg|Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
110196|NCT01934192|O5|Outcome|Baseline EN Intolerant: Camicinal 50 mg|Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
110197|NCT01934192|O4|Outcome|Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
110198|NCT01934192|O3|Outcome|Baseline EN Tolerant: Placebo/Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
110199|NCT01934192|O2|Outcome|Baseline EN Tolerant: Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
110200|NCT01934192|O1|Outcome|Baseline EN Tolerant: Placebo|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
110201|NCT01934192|O6|Outcome|Baseline EN Intolerant: Metoclopramide 10 mg|Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
110202|NCT01934192|O5|Outcome|Baseline EN Intolerant: Camicinal 50 mg|Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
110203|NCT01934192|O4|Outcome|Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
110204|NCT01934192|O3|Outcome|Baseline EN Tolerant: Placebo/Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
110488|NCT01933243|O1|Outcome|PUFA|Participants randomized to omega-3 PUFA
110205|NCT01934192|O2|Outcome|Baseline EN Tolerant: Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
110206|NCT01934192|O1|Outcome|Baseline EN Tolerant: Placebo|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
110207|NCT01934192|O6|Outcome|Baseline EN Intolerant: Metoclopramide 10 mg|Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
110208|NCT01934192|O5|Outcome|Baseline EN Intolerant: Camicinal 50 mg|Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
110209|NCT01934192|O4|Outcome|Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.
110210|NCT01934192|O3|Outcome|Baseline EN Tolerant: Placebo/Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
110211|NCT01934192|O2|Outcome|Baseline EN Tolerant: Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
110212|NCT01934192|O1|Outcome|Baseline EN Tolerant: Placebo|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
110213|NCT01934192|O2|Outcome|Placebo|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
110214|NCT01934192|O1|Outcome|Camicinal 50 mg|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
110215|NCT01934192|O2|Outcome|Placebo|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
110216|NCT01934192|O1|Outcome|Camicinal 50 mg|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
110217|NCT01934192|O2|Outcome|Placebo|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
110218|NCT01934192|O1|Outcome|Camicinal 50 mg|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
110219|NCT01934192|O2|Outcome|Placebo|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
110220|NCT01934192|O1|Outcome|Camicinal 50 mg|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
110221|NCT01934192|O2|Outcome|Placebo|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
110222|NCT01934192|O1|Outcome|Camicinal 50 mg|EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
110223|NCT01934192|E6|Reported Event|Baseline EN Intolerant: Metoclopramide 10 mg|Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
110224|NCT01934192|E5|Reported Event|Baseline EN Intolerant: Camicinal 50 mg|Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
110225|NCT01934192|E4|Reported Event|Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
110226|NCT01934192|E3|Reported Event|Baseline EN Tolerant: Placebo/Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
110227|NCT01934192|E2|Reported Event|Baseline EN Tolerant: Camicinal 50 mg|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
110228|NCT01934192|E1|Reported Event|Baseline EN Tolerant: Placebo|Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
110229|NCT01934010|B4|Baseline|Total|Total of all reporting groups
110230|NCT01934010|B3|Baseline|3 Cycles AM-101|Subjects that participated in all 3 treatment cycles of the AMPACT1 study, received 3 x 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days. The subjects could only roll-over if they completed the final follow-up of the previous cycle and were still eligible. In cycle 1 treatment was within D0 - D4. Cycle 2 treatment within D84 - D88. And treatment for cycle 3 within D168-D172. Final follow-up after 3 treatment cycles was FUV9 (D252).
110231|NCT01934010|B2|Baseline|2 Cycles AM-101|Subjects that participated in 2 treatment cycles of the AMPACT1 study, received 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days (D0 - D4) in cycle 1 and after final follow-up (D84) of cycle 1, they rolled-over to treatment cycle 2 receiving once more 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days (D84 - D88).
110232|NCT01934010|B1|Baseline|1 Cycle AM-101|Subjects participated in 1 treatment cycle and received one round of 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days (D0-D4)
110233|NCT01934010|P3|Participant Flow|3 Cycles AM-101|Subjects that participated in all 3 treatment cycles of the AMPACT1 study, received 3 x 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days. The subjects could only roll-over if they completed the final follow-up of the previous cycle and were still eligible. In cycle 1 treatment was within D0 - D4. Cycle 2 treatment within D84 - D88. And treatment for cycle 3 within D168-D172. Final follow-up after 3 treatment cycles was FUV9 (D252).
110489|NCT01933243|E2|Reported Event|Placebo|Participants randomized to placebo
110234|NCT01934010|P2|Participant Flow|2 Cycles AM-101|Subjects that participated in 2 treatment cycles of the AMPACT1 study, received 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days (D0 - D4) in cycle 1 and after final follow-up (D84) of cycle 1, they rolled-over to treatment cycle 2 receiving once more 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days (D84 - D88).
110235|NCT01934010|P1|Participant Flow|1 Cycle AM-101|Subjects participated in 1 treatment cycle and received one round of 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days (D0-D4)
110236|NCT01934010|O1|Outcome|3 Cycles AM-101|Subjects that participated in 3 treatment cycles. This endpoint lists deteriorations at FUV9.
110237|NCT01934010|O2|Outcome|3 Cycles AM-101|Subjects that participated in 3 treatment cycles. This endpoint lists deteriorations at FUV6.
110238|NCT01934010|O1|Outcome|2 Cycles AM-101|Subjects that participated in 2 treatment cycles. This endpoint lists deteriorations at FUV6.
110239|NCT01934010|O3|Outcome|3 Cycles AM-101|Subjects that participated in 3 treatment cycles. This endpoint lists deteriorations at FUV3.
110240|NCT01934010|O2|Outcome|2 Cycles AM-101|Subjects that participated in 2 treatment cycles. This endpoint lists deteriorations at FUV3.
110241|NCT01934010|O1|Outcome|1 Cycle AM-101|Subjects that participated only in 1 treatment cycle. This endpoint counts existing deteriorations at FUV3.
110242|NCT01934010|O1|Outcome|3 Cycles AM-101|Subjects that participated in 3 treatment cycles. This endpoint lists deteriorations at FUV8.
110243|NCT01934010|O2|Outcome|3 Cycles AM-101|Subjects that participated in 3 treatment cycles. This endpoint lists deteriorations at FUV5.
110244|NCT01934010|O1|Outcome|2 Cycles AM-101|Subjects that participated in 2 treatment cycles. This endpoint lists deteriorations at FUV5.
110245|NCT01934010|O3|Outcome|3 Cycles AM-101|Subjects that participated in 3 treatment cycles. This endpoint lists deteriorations at FUV2.
110246|NCT01934010|O2|Outcome|2 Cycles AM-101|Subjects that participated in 2 treatment cycles. This endpoint lists deteriorations at FUV2.
110247|NCT01934010|O1|Outcome|1 Cycle AM-101|Subjects that participated only in 1 treatment cycle. This endpoint counts existing deteriorations at FUV2.
110248|NCT01934010|E3|Reported Event|3 Cycles AM-101|Subjects that participated in all 3 treatment cycles of the AMPACT1 study, received 3 x 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days. The subjects could only roll-over if they completed the final follow-up of the previous cycle and were still eligible. In cycle 1 treatment was within D0 - D4. Cycle 2 treatment within D84 - D88. And treatment for cycle 3 within D168-D172. Final follow-up after 3 treatment cycles was FUV9 (D252).
110249|NCT01934010|E2|Reported Event|2 Cycles AM-101|Subjects that participated in 2 treatment cycles of the AMPACT1 study, received 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days (D0 - D4) in cycle 1 and after final follow-up (D84) of cycle 1, they rolled-over to treatment cycle 2 receiving once more 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days (D84 - D88).
110250|NCT01934010|E1|Reported Event|1 Cycle AM-101|Subjects participated in 1 treatment cycle and received one round of 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days (D0-D4)
110251|NCT01933932|B3|Baseline|Total|Total of all reporting groups
110252|NCT01933932|B2|Baseline|Placebo + Docetaxel|Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
110253|NCT01933932|B1|Baseline|Selumetinib + Docetaxel|Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
110254|NCT01933932|P2|Participant Flow|Placebo + Docetaxel|Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
110255|NCT01933932|P1|Participant Flow|Selumetinib + Docetaxel|Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
110256|NCT01933932|O2|Outcome|Placebo + Docetaxel|Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
110257|NCT01933932|O1|Outcome|Selumetinib + Docetaxel|Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
110258|NCT01933932|O2|Outcome|Placebo + Docetaxel|Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
110259|NCT01933932|O1|Outcome|Selumetinib + Docetaxel|Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
110260|NCT01933932|O2|Outcome|Placebo + Docetaxel|Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
110261|NCT01933932|O1|Outcome|Selumetinib + Docetaxel|Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
110262|NCT01933932|O2|Outcome|Placebo + Docetaxel|Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
110263|NCT01933932|O1|Outcome|Selumetinib + Docetaxel|Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
110264|NCT01933932|O2|Outcome|Placebo + Docetaxel|Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
110265|NCT01933932|O1|Outcome|Selumetinib + Docetaxel|Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
110266|NCT01933932|O2|Outcome|Placebo + Docetaxel|Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
110385|NCT01933776|E1|Reported Event|ADACEL™ Vaccine Group 1|Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
110267|NCT01933932|O1|Outcome|Selumetinib + Docetaxel|Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
110268|NCT01933932|E2|Reported Event|Selumetinib + Docetaxel|Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
110269|NCT01933932|E1|Reported Event|Placebo + Docetaxel|Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
110270|NCT01933919|B3|Baseline|Total|Total of all reporting groups
110271|NCT01933919|B2|Baseline|Placebo|"In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.~In the open-label long-term phase participants received 25 mg fluvoxamine once a day for the first week, 25 mg BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by one tablet/day/week up to a maximum of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week."
110272|NCT01933919|B1|Baseline|Fluvoxamine|"In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.~In the open-label long-term phase participants received 25 mg fluvoxamine once a day for the first week, 25 mg BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by 25 mg/day/week up to a maximum dose of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week."
110273|NCT01933919|P2|Participant Flow|Placebo|"In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.~In the open-label long-term phase participants received 25 mg fluvoxamine once a day for the first week, 25 mg BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by one tablet/day/week up to a maximum of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week."
110274|NCT01933919|P1|Participant Flow|Fluvoxamine|"In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.~In the open-label long-term phase participants received 25 mg fluvoxamine once a day for the first week, 25 mg BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by 25 mg/day/week up to a maximum dose of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week."
110275|NCT01933919|O2|Outcome|Placebo/Fluvoxamine|In the open-label long-term phase participants who received placebo in the first phase then received 25 mg fluvoxamine once a day for the first week, 25 mg fluvoxamine BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by one tablet/day/week up to a maximum of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week.
110276|NCT01933919|O1|Outcome|Fluvoxamine/Fluvoxamine|In the open-label long-term phase participants who received fluvoxamine in the first phase then received 25 mg fluvoxamine once a day for the first week, 25 mg fluvoxamine BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by 25 mg/day/week up to a maximum dose of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week.
110277|NCT01933919|O2|Outcome|Placebo|In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
110278|NCT01933919|O1|Outcome|Fluvoxamine|In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.
110279|NCT01933919|O2|Outcome|Placebo/Fluvoxamine|In the open-label long-term phase participants who received placebo in the first phase then received 25 mg fluvoxamine once a day for the first week, 25 mg fluvoxamine BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by one tablet/day/week up to a maximum of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week.
119762|NCT01889667|O3|Outcome|Placebo|"Oil Capsules~Placebo: Oil Capsules"
110280|NCT01933919|O1|Outcome|Fluvoxamine/Fluvoxamine|In the open-label long-term phase participants who received fluvoxamine in the first phase then received 25 mg fluvoxamine once a day for the first week, 25 mg fluvoxamine BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by 25 mg/day/week up to a maximum dose of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week.
110281|NCT01933919|O2|Outcome|Placebo/Fluvoxamine|In the open-label long-term phase participants who received placebo in the first phase then received 25 mg fluvoxamine once a day for the first week, 25 mg fluvoxamine BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by one tablet/day/week up to a maximum of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week.
110282|NCT01933919|O1|Outcome|Fluvoxamine/Fluvoxamine|In the open-label long-term phase participants who received fluvoxamine in the first phase then received 25 mg fluvoxamine once a day for the first week, 25 mg fluvoxamine BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by 25 mg/day/week up to a maximum dose of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week.
110283|NCT01933919|O2|Outcome|Placebo|In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
110284|NCT01933919|O1|Outcome|Fluvoxamine|In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.
110285|NCT01933919|O2|Outcome|Placebo|In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
110286|NCT01933919|O1|Outcome|Fluvoxamine|In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.
110287|NCT01933919|O2|Outcome|Placebo|In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
110288|NCT01933919|O1|Outcome|Fluvoxamine|In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.
110289|NCT01933919|O2|Outcome|Placebo|In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
110290|NCT01933919|O1|Outcome|Fluvoxamine|In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.
110291|NCT01933919|O2|Outcome|Placebo|In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
110292|NCT01933919|O1|Outcome|Fluvoxamine|In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.
110334|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
121092|NCT01880840|B3|Baseline|Total|Total of all reporting groups
110293|NCT01933919|O4|Outcome|Placebo - Females|In the double-blind placebo-controlled phase female participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
110294|NCT01933919|O3|Outcome|Fluvoxamine - Females|In the double-blind placebo-controlled phase female participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.
110295|NCT01933919|O2|Outcome|Placebo - Males|In the double-blind placebo-controlled phase male participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
110296|NCT01933919|O1|Outcome|Fluvoxamine - Males|In the double-blind placebo-controlled phase male participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.
110297|NCT01933919|O4|Outcome|Placebo - Ages 12-18|In the double-blind placebo-controlled phase participants aged 12 to 18 years received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
110298|NCT01933919|O3|Outcome|Fluvoxamine - Ages 12-18|In the double-blind placebo-controlled phase participants aged 12 to 18 years received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.
110299|NCT01933919|O2|Outcome|Placebo - Ages 6-11|In the double-blind placebo-controlled phase participants aged 6 to 11 years received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
110300|NCT01933919|O1|Outcome|Fluvoxamine - Ages 6-11|In the double-blind placebo-controlled phase participants aged 6 to 11 years received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.
110301|NCT01933919|O2|Outcome|Placebo|In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
110302|NCT01933919|O1|Outcome|Fluvoxamine|In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.
110303|NCT01933919|E4|Reported Event|Second Phase: Placebo/Fluvoxamine|In the open-label long-term phase participants who received placebo in the first phase then received 25 mg fluvoxamine once a day for the first week, 25 mg fluvoxamine BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by one tablet/day/week up to a maximum of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week.
110304|NCT01933919|E3|Reported Event|Second Phase: Fluvoxamine/Fluvoxamine|In the open-label long-term phase participants who received fluvoxamine in the first phase then received 25 mg fluvoxamine once a day for the first week, 25 mg fluvoxamine BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by 25 mg/day/week up to a maximum dose of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week.
110305|NCT01933919|E2|Reported Event|First Phase: Placebo|In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
124576|NCT01863134|B3|Baseline|Total|Total of all reporting groups
110306|NCT01933919|E1|Reported Event|First Phase: Fluvoxamine|In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.
110307|NCT01933880|B3|Baseline|Total|Total of all reporting groups
110308|NCT01933880|B2|Baseline|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
110309|NCT01933880|B1|Baseline|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110310|NCT01933880|P2|Participant Flow|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
110311|NCT01933880|P1|Participant Flow|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110312|NCT01933880|O2|Outcome|Normal|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
110313|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110314|NCT01933880|O3|Outcome|OROS-MPH Group 54 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d).
110315|NCT01933880|O2|Outcome|OROS-MPH Group 36 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 36 milligram per day (mg/d).
110316|NCT01933880|O1|Outcome|OROS-MPH Group 18 Milligram (mg)|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 18 milligram per day (mg/d).
110317|NCT01933880|O3|Outcome|OROS-MPH Group 54 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d).
110318|NCT01933880|O2|Outcome|OROS-MPH Group 36 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 36 milligram per day (mg/d)
110319|NCT01933880|O1|Outcome|OROS-MPH Group 18 Milligram (mg)|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 18 milligram per day (mg/d).
110320|NCT01933880|O3|Outcome|OROS-MPH Group 54 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
110321|NCT01933880|O2|Outcome|OROS-MPH Group 36 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 36 milligram per day (mg/d)
110322|NCT01933880|O1|Outcome|OROS-MPH Group 18 Milligram (mg)|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 18 milligram per day (mg/d).
110323|NCT01933880|O3|Outcome|OROS-MPH Group 54 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
110324|NCT01933880|O2|Outcome|OROS-MPH Group 36 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 36 milligram per day (mg/d)
110325|NCT01933880|O1|Outcome|OROS-MPH Group 18 Milligram (mg)|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 18 milligram per day (mg/d).
110326|NCT01933880|O2|Outcome|Normal|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
110327|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110328|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
110329|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110330|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
110331|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110332|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
110333|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
127142|NCT01852162|O2|Outcome|Placebo|Placebo tablets
110335|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110336|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
110337|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110338|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
110339|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110340|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
110341|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110342|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
110343|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110344|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
110345|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110346|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
110347|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110348|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
110349|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110350|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
110351|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110352|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
110353|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110354|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
110355|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110356|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
110490|NCT01933243|E1|Reported Event|PUFA|Participants randomized to omega-3 PUFA
110357|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110358|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
110359|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110360|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
110361|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110362|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
110363|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110364|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
110365|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110366|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
110367|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110368|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
110369|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110370|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
110371|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110372|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
110373|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110374|NCT01933880|E1|Reported Event|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
110375|NCT01933776|B3|Baseline|Total|Total of all reporting groups
110376|NCT01933776|B2|Baseline|ADACEL™ Vaccine Group 2|Children 4 to 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
110377|NCT01933776|B1|Baseline|ADACEL™ Vaccine Group 1|Adults 18 to 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
110378|NCT01933776|P2|Participant Flow|ADACEL™ Vaccine Group 2 (Children)|Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
110379|NCT01933776|P1|Participant Flow|ADACEL™ Vaccine Group 1 (Adults)|Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
110380|NCT01933776|O2|Outcome|ADACEL™ Vaccine Group 2|Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
110381|NCT01933776|O1|Outcome|ADACEL™ Vaccine Group 1|Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
110382|NCT01933776|O2|Outcome|ADACEL™ Vaccine Group 2|Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
110386|NCT01933672|B1|Baseline|All*|A total of 90 participants with T2DM were consented for this study; of these, 43 transitioned into run-in with Sponsor-provided metformin and a total of 33 participants were randomized.
110387|NCT01933672|P7|Participant Flow|Sitagliptin Then PF-04937319 300mg Then PF-04937319 150+100mg|Participants received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the first intervention period; and then received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the second intervention period; and then received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the third intervention period.
110388|NCT01933672|P6|Participant Flow|Sitagliptin Then PF-04937319 150+100mg Then PF-04937319 300mg|Participants received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the first intervention period; and then received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the second intervention period; and then received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the third intervention period.
110389|NCT01933672|P5|Participant Flow|PF-04937319 300mg Then Sitagliptin Then PF-04937319 150+100mg|Participants received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the first intervention period; and then received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the second intervention period; and then received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the first intervention period.
110390|NCT01933672|P4|Participant Flow|PF-04937319 300mg Then PF-04937319 150+100mg Then Sitagliptin|Participants received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the first intervention period; and then received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the second intervention period; and then received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days.
110391|NCT01933672|P3|Participant Flow|PF-04937319 150+100mg Then Sitagliptin Then PF-04937319 300mg|Participants received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the first intervention period; and then received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the second intervention period; and then received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the third intervention period.
110392|NCT01933672|P2|Participant Flow|PF-04937319 150+100mg Then PF-04937319 300mg Then Sitagliptin|Participants received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the first intervention period; and then received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the second intervention period; and then received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the third intervention period.
110393|NCT01933672|P1|Participant Flow|Metformin Run-in|Sponsor-provided, open-label metformin was administered from the run-in visit to the follow-up visit, inclusive, and it was provided as 500 milligram (mg) immediate-release tablets.
110394|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110395|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110396|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110397|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110398|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110399|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110400|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110401|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110402|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110403|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110404|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110405|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110406|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110407|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110408|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110409|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110410|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110411|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110412|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110456|NCT01933399|O3|Outcome|Inextensible Lumbosacral Orthoses and Standard of Care|"This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.~Inextensible LSO (stiff back support): Cotton/nylon canvas back support with velcro fasteners."
110413|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110414|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110415|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110416|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110417|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110418|NCT01933672|O4|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110419|NCT01933672|O3|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110420|NCT01933672|O2|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110421|NCT01933672|O1|Outcome|Metformin Run-in|Participants were instructed to take the morning dose of the study medication and at least 1 dose of open label metformin at the same time of day with the morning meal each day.
110422|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110423|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110424|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110425|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110426|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110427|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110428|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110429|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110430|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110482|NCT01933243|P1|Participant Flow|PUFA|"Fish oil for 12 weeks~Fish oil: Participants will take 4 capsules daily"
110431|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110432|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110433|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110434|NCT01933672|E4|Reported Event|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110435|NCT01933672|E3|Reported Event|PF-04937319 300 mg (Once Daily)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110436|NCT01933672|E2|Reported Event|PF-04937319 150+100 mg (Split Dose)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
110437|NCT01933672|E1|Reported Event|Metformin Run-in|Sponsor-provided, open-label metformin was administered from the run-in visit to the follow-up visit, inclusive, and it was provided as 500 mg immediate-release tablets.
110438|NCT01933425|B1|Baseline|Patient Characteristics in 14 Women|
110439|NCT01933425|P2|Participant Flow|No Neuromuscular Block First Then Deep Neuromuscular Block|"No neuromuscular blockade with placebo followed by deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg and reversal with sugammadex 8 mg/kg.~Measurements of intraabdominal distance during no neuromuscular blockade and during deep neuromuscular blockade.~rocuronium~sugammadex~placebo"
110440|NCT01933425|P1|Participant Flow|Deep Neuromuscular Block First Then no Neuromuscular Block|"Deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg followed by no neuromuscular blockade with sugammadex 8 mg/kg and placebo reversal.~Measurements of intraabdominal distance during deep neuromuscular blockade and without neuromuscular blockade~rocuronium~sugammadex~placebo"
110441|NCT01933425|O2|Outcome|no Neuromuscular Blockade|"No neuromuscular blockade with placebo followed by deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg and reversal with sugammadex 8 mg/kg.~Measurements of intraabdominal distance during no neuromuscular blockade and during deep neuromuscular blockade.~rocuronium~sugammadex~placebo"
110442|NCT01933425|O1|Outcome|Deep Neuromuscular Blockade|"Deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg followed by no neuromuscular blockade with sugammadex 8 mg/kg and placebo reversal.~Measurements of intraabdominal distance during deep neuromuscular blockade and without neuromuscular blockade~rocuronium~sugammadex~placebo"
110443|NCT01933425|O2|Outcome|No Neuromuscular Block|Intraabdominal distance during no neuromuscular block
110444|NCT01933425|O1|Outcome|Deep Neuromuscular Block|Intraabdominal distance during deep neuromuscular blockade (PTC 0-1).
110445|NCT01933425|O2|Outcome|No Neuromuscular Block|Intraabdominal distance during no neuromuscular block
110446|NCT01933425|O1|Outcome|Deep Neuromuscular Block|Intraabdominal distance during deep neuromuscular blockade (PTC 0-1).
110447|NCT01933425|E2|Reported Event|No Neuromuscular Block First Then Deep Neuromuscular Block|Difference in intraabdominal distance comparing deep neuromuscular blockade (PTC 0-1) with no neuromuscular blockade.
110448|NCT01933425|E1|Reported Event|Deep Neuromuscular Block First Then no Neuromuscular Block|Difference in intraabdominal distance comparing deep neuromuscular blockade (PTC 0-1) with no neuromuscular blockade.
110449|NCT01933399|B4|Baseline|Total|Total of all reporting groups
110450|NCT01933399|B3|Baseline|Inextensible Lumbosacral Orthoses and Standard of Care|"This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.~Inextensible LSO (stiff back support): Cotton/nylon canvas back support with velcro fasteners."
110451|NCT01933399|B2|Baseline|Extensible Lumbosacral Orthoses Plus Standard of Care|"This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter~Extensible LSO, a back support that is flexible: Back support is constructed from lycra and neoprene with velcro fasteners."
110452|NCT01933399|B1|Baseline|Standard of Care|"Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.~Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy."
110453|NCT01933399|P3|Participant Flow|Inextensible Lumbosacral Orthoses and Standard of Care|"This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.~Inextensible LSO (stiff back support): Cotton/nylon canvas back support with velcro fasteners."
110454|NCT01933399|P2|Participant Flow|Extensible Lumbosacral Orthoses Plus Standard of Care|"This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter~Extensible LSO, a back support that is flexible: Back support is constructed from lycra and neoprene with velcro fasteners."
110455|NCT01933399|P1|Participant Flow|Standard of Care|"Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.~Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy."
110483|NCT01933243|O2|Outcome|Placebo|Participants randomized to placebo
110457|NCT01933399|O2|Outcome|Extensible Lumbosacral Orthoses Plus Standard of Care|"This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter~Extensible LSO, a back support that is flexible: Back support is constructed from lycra and neoprene with velcro fasteners."
110458|NCT01933399|O1|Outcome|Standard of Care|"Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.~Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy."
110459|NCT01933399|O3|Outcome|Inextensible Lumbosacral Orthoses and Standard of Care|"This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.~Inextensible LSO (stiff back support): Cotton/nylon canvas back support with velcro fasteners."
110460|NCT01933399|O2|Outcome|Extensible Lumbosacral Orthoses Plus Standard of Care|"This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter~Extensible LSO, a back support that is flexible: Back support is constructed from lycra and neoprene with velcro fasteners."
110461|NCT01933399|O1|Outcome|Standard of Care|"Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.~Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy."
110462|NCT01933399|E3|Reported Event|Inextensible Lumbosacral Orthoses and Standard of Care|"This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.~Inextensible LSO (stiff back support): Cotton/nylon canvas back support with velcro fasteners."
110463|NCT01933399|E2|Reported Event|Extensible Lumbosacral Orthoses Plus Standard of Care|"This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter~Extensible LSO, a back support that is flexible: Back support is constructed from lycra and neoprene with velcro fasteners."
110464|NCT01933399|E1|Reported Event|Standard of Care|"Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.~Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy."
110465|NCT01933334|B3|Baseline|Total|Total of all reporting groups
110466|NCT01933334|B2|Baseline|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
110467|NCT01933334|B1|Baseline|Pirfenidone: 2-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
110468|NCT01933334|P2|Participant Flow|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
110469|NCT01933334|P1|Participant Flow|Pirfenidone: 2-Week Titration Group|Participants received one 267 milligrams (mg) oral pirfenidone capsule three times daily (TID) (801 mg per day [mg/day]) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
110470|NCT01933334|O2|Outcome|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
110471|NCT01933334|O1|Outcome|Pirfenidone: 2-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
110472|NCT01933334|O2|Outcome|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
110473|NCT01933334|O1|Outcome|Pirfenidone: 2-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
110474|NCT01933334|O2|Outcome|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
110475|NCT01933334|O1|Outcome|Pirfenidone: 2-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
110476|NCT01933334|E2|Reported Event|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
110477|NCT01933334|E1|Reported Event|Pirfenidone: 2-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
110478|NCT01933243|B3|Baseline|Total|Total of all reporting groups
110479|NCT01933243|B2|Baseline|Placebo|Participants randomized to placebo
110480|NCT01933243|B1|Baseline|PUFA|Participants randomized to omega-3 PUFA
110481|NCT01933243|P2|Participant Flow|Placebo Pill|"Placebo pills for 12 weeks~Placebo pill: Participants will take 4 capsules daily"
110491|NCT01933230|B1|Baseline|Excel Cryo Cooling System Collar|"We will place an Excel Cryo Cooling System collar around your neck for a 2 hour neck cooling period. The cooling packs will be changed every 20 minutes for the two-hour duration of the study. During the study and for two hours after, we will collect data concerning the brain temperature (if applicable), body temperature, brain oxygen level (if applicable) and pressure both in the head (if applicable) and in the blood (blood pressure).~We will place an Excel Cryo Cooling System collar around your neck for two hours. The cooling packs will be changed every 20 minutes for the two-hour duration of the study. During the study and for two hours after, we will collect data concerning the brain temperature (if applicable), body temperature, brain oxygen level (if applicable) and pressure both in the head (if applicable) and in the blood (blood pressure).~2 hour neck cooling period"
110492|NCT01933230|P1|Participant Flow|Excel Cryo Cooling System Collar|"We will place an Excel Cryo Cooling System collar around your neck for a 2 hour neck cooling period. This will cool the blood in the neck that goes to the brain causing the brain to become cool as well. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar that delivers the cold. The cooling pack is similar to, but not the same as, the cooling packs used for sports injuries. The cooling packs will be changed every 20 minutes for the two-hour duration of the study. During the study and for two hours after, we will collect data concerning the brain temperature (if applicable), body temperature, brain oxygen level (if applicable) and pressure both in the head (if applicable) and in the blood (blood pressure).~Excel Cryo Cooling System: We will place an Excel Cryo Cooling System collar around your neck for two hours."
110493|NCT01933230|O1|Outcome|Excel Cryo Cooling System Collar|We will place an Excel Cryo Cooling System collar around your neck for a 2 hour neck cooling period. This will cool the blood in the neck that goes to the brain causing the brain to become cool as well. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar that delivers the cold. The cooling pack is similar to, but not the same as, the cooling packs used for sports injuries. The cooling packs will be changed every 20 minutes for the two-hour duration of the study. During the study and for two hours after, we will collect data concerning the brain temperature (if applicable), body temperature, brain oxygen level (if applicable) and pressure both in the head (if applicable) and in the blood (blood pressure).
110494|NCT01933230|E1|Reported Event|Excel Cryo Cooling System Collar|"We will place an Excel Cryo Cooling System collar around your neck for two hours. This will cool the blood in the neck that goes to the brain causing the brain to become cool as well. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar that delivers the cold. The cooling pack is similar to, but not the same as, the cooling packs used for sports injuries. The cooling packs will be changed every 20 minutes for the two-hour duration of the study. During the study and for two hours after, we will collect data concerning the brain temperature (if applicable), body temperature, brain oxygen level (if applicable) and pressure both in the head (if applicable) and in the blood (blood pressure).~2 hour neck cooling period"
110495|NCT01933048|B3|Baseline|Total|Total of all reporting groups
110496|NCT01933048|B2|Baseline|Self-Administration|FluMist self-administered by subject
110497|NCT01933048|B1|Baseline|Healthcare Worker Administration|FluMist administered by a Healthcare Worker
110498|NCT01933048|P2|Participant Flow|Self-Administration (SA)|FluMist self-administered by subject
110499|NCT01933048|P1|Participant Flow|Healthcare Worker Administration (HCWA)|FluMist administered by a Healthcare Worker
110500|NCT01933048|O1|Outcome|Self-Administration (SA)|"FluMist self-administered by subject~FluMist: FluMist Intranasal Vaccine~Self-administered (SA)/singleton (n=178), SA/groups of 5 (n=163), and SA/groups of 10 (n=160)."
110501|NCT01933048|O2|Outcome|Self-Administration (SA)|"FluMist self-administered by subject~FluMist: FluMist Intranasal Vaccine~Self-administered (SA)/singleton (n=178), SA/groups of 5 (n=163), and SA/groups of 10 (n=160)."
110502|NCT01933048|O1|Outcome|Healthcare Worker Administration (HCWA)|"FluMist administered by a Healthcare Worker~FluMist: FluMist Intranasal Vaccine~Health care worker-administered (HCWA; n=523)"
110503|NCT01933048|O2|Outcome|Self-Administration|FluMist self-administered by subject
110504|NCT01933048|O1|Outcome|Healthcare Worker Administration|FluMist administered by a Healthcare Worker
110505|NCT01933048|O2|Outcome|Self-Administration|FluMist self-administered by subject
110506|NCT01933048|O1|Outcome|Healthcare Worker Administration|FluMist administered by a Healthcare Worker
110507|NCT01933048|O2|Outcome|Self-Administration|FluMist self-administered by subject
110508|NCT01933048|O1|Outcome|Healthcare Worker Administration|FluMist administered by a Healthcare Worker
110509|NCT01933048|E2|Reported Event|Self-Administration|This group includes subjects who self-administered FluMist.
110510|NCT01933048|E1|Reported Event|Healthcare Worker Administration|This group includes healthcare worker administration of FluMist to subjects.
110511|NCT01932970|B1|Baseline|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
110512|NCT01932970|P1|Participant Flow|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
110513|NCT01932970|O1|Outcome|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
110514|NCT01932970|O1|Outcome|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
110515|NCT01932970|O1|Outcome|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
110516|NCT01932970|O1|Outcome|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
110517|NCT01932970|O1|Outcome|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
127143|NCT01852162|O1|Outcome|Dabigatran|Dabigatran 150mg
110518|NCT01932970|E1|Reported Event|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
110519|NCT01932762|B5|Baseline|Total|Total of all reporting groups
110520|NCT01932762|B4|Baseline|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
110521|NCT01932762|B3|Baseline|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
110522|NCT01932762|B2|Baseline|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
110523|NCT01932762|B1|Baseline|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
110524|NCT01932762|P4|Participant Flow|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
110525|NCT01932762|P3|Participant Flow|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
110526|NCT01932762|P2|Participant Flow|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
110527|NCT01932762|P1|Participant Flow|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of ribavirin (RBV) for 12 weeks.
110528|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
110529|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
110530|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
110531|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
110532|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
110533|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
110534|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
110535|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
110536|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
110537|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
110538|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
110539|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
110540|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
110541|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
110542|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
110543|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
110544|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
110545|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
110546|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
110547|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
110548|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
110549|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
110550|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
110551|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
111442|NCT01929031|E4|Reported Event|Ibuprofen/Caffeine|Ibuprofen 400mg / Caffeine 100mg tablet
110552|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
110553|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
110554|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
110555|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
110556|NCT01932762|E4|Reported Event|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
110557|NCT01932762|E3|Reported Event|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
110558|NCT01932762|E2|Reported Event|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
110559|NCT01932762|E1|Reported Event|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
110560|NCT01932606|B3|Baseline|Total|Total of all reporting groups
110561|NCT01932606|B2|Baseline|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
110562|NCT01932606|B1|Baseline|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
110563|NCT01932606|P2|Participant Flow|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
110564|NCT01932606|P1|Participant Flow|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
110565|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
110566|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
110567|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
110568|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
110569|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
110570|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
110571|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
110572|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
110573|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
110574|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
110575|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
110576|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
110577|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
110578|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
110579|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
110580|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
110581|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
110582|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
110583|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
110584|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
110585|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
110586|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
110587|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
110588|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
110589|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
110590|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
110591|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
110592|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
110593|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
110594|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
111443|NCT01929031|E3|Reported Event|Ibuprofen|Ibuprofen 400mg tablet
110595|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
110596|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
110597|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
110598|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
110599|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
110600|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
110601|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
110602|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
110603|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
110604|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
110605|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
110606|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
110607|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
110608|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
110609|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
110610|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
110611|NCT01932606|E2|Reported Event|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
110612|NCT01932606|E1|Reported Event|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
110613|NCT01932164|B1|Baseline|Cleft Lip and Palate|"5 Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment will be selected to be submited to alveolar bone tissue engineering surgery~maxillary alveolar graft by tissue engineering: Extraction of deciduous teeth of cleft lip and palate patients to obtain mesenchymal stem cells;~Bone tissue engineering using mesenchymal stem cells: Secondary alveolar graft in patients with cleft lip and palate using using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite."
110614|NCT01932164|P1|Participant Flow|Cleft Lip and Palate|"Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment~maxillary alveolar graft by tissue engineering: Extraction of deciduous tooth of cleft lip and palate patients to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite."
110615|NCT01932164|O1|Outcome|Cleft Lip and Palate|"Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment~maxillary alveolar graft by tissue engineering: Extraction of deciduous tooth of cleft lip and palate patients to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite."
110616|NCT01932164|O1|Outcome|Cleft Lip and Palate|"Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment~maxillary alveolar graft by tissue engineering: Extraction of deciduous tooth of cleft lip and palate patients to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite."
110617|NCT01932164|E1|Reported Event|Cleft Lip and Palate|"Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment~maxillary alveolar graft by tissue engineering: Extraction of deciduous tooth of cleft lip and palate patients to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite."
110618|NCT01932112|B1|Baseline|Adenosine Arm|"After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.~Adenosine arm: After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection."
110619|NCT01932112|P1|Participant Flow|Adenosine Arm|"After pulmonary vein isolation, 20mg Iv adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.~Adenosine arm: After pulmonary vein isolation, 20mg Iv adenosine will be given to treatment group, will evaluate pulmonary vein reconnection."
110620|NCT01932112|O1|Outcome|Adenosine Arm|"After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.~Adenosine arm: After pulmonary vein isolation, 12mg Iv adenosine will be given to treatment group, will evaluate pulmonary vein reconnection."
110621|NCT01932112|E1|Reported Event|Adenosine Arm|"After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.~Adenosine arm: After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection."
110622|NCT01932060|B3|Baseline|Total|Total of all reporting groups
110872|NCT01931527|B1|Baseline|Low Uric Acid|16 obese subjects (BMI 37.1±0.7 kg/m2) with uric acid <5mg/dL
111084|NCT01930162|B1|Baseline|HSC835|Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen.
110623|NCT01932060|B2|Baseline|Oxytocin Infusion 2|"Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
110624|NCT01932060|B1|Baseline|Oxytocin Infusion 1|"Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
110625|NCT01932060|P2|Participant Flow|Oxytocin Infusion 2|"Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
110626|NCT01932060|P1|Participant Flow|Oxytocin Infusion 1|"Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
110627|NCT01932060|O2|Outcome|Oxytocin Infusion 2|"Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
110628|NCT01932060|O1|Outcome|Oxytocin Infusion 1|"Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
110629|NCT01932060|O2|Outcome|Oxytocin Infusion 2|"Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
110630|NCT01932060|O1|Outcome|Oxytocin Infusion 1|"Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
110631|NCT01932060|E2|Reported Event|Oxytocin Infusion 2|"Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
110632|NCT01932060|E1|Reported Event|Oxytocin Infusion 1|"Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
110633|NCT01931956|B3|Baseline|Total|Total of all reporting groups
110634|NCT01931956|B2|Baseline|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110635|NCT01931956|B1|Baseline|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110636|NCT01931956|P2|Participant Flow|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110637|NCT01931956|P1|Participant Flow|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110638|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110929|NCT01931397|O1|Outcome|Total Cohort|This is a prospective non randomized study. All patients were approached at the pediatric kidney transplant clinic at OHSU in a non randomized fashion until the target enrollment of 30 patients was met.
110639|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110640|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110641|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110642|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110643|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110644|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110645|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110646|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110647|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110648|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110649|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110650|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
111130|NCT01930045|O3|Outcome|Raltegravir → 6 Hours → Maalox|400 mg Raltegravir followed 6 hrs later by 20 mL Maalox
110651|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110652|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110653|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110654|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110655|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110656|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110657|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110658|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110659|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110660|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110661|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110662|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
111085|NCT01930162|P1|Participant Flow|HSC835|Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen.
110663|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110664|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110665|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110666|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110667|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110668|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110669|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110670|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110671|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110672|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110673|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110674|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
111086|NCT01930162|O1|Outcome|HSC835|Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen.
110675|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110676|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110677|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110678|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110679|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110680|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110681|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110682|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110683|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110684|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110685|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110686|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
111087|NCT01930162|O1|Outcome|HSC835|Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen.
110687|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110688|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110689|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110690|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110691|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110692|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110693|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110694|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110695|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110696|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110697|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110698|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
111088|NCT01930162|O1|Outcome|HSC835|Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen.
110699|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110700|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110701|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110702|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110703|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110704|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110705|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110706|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110707|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110708|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110709|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110710|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
111089|NCT01930162|O1|Outcome|HSC835|Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen.
110711|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110712|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110713|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110714|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110715|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110716|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110717|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110718|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110719|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110720|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110721|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110722|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
111090|NCT01930162|O1|Outcome|HSC835|Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen.
110723|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110724|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110725|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110726|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110727|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110728|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110729|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110730|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110731|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110732|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110733|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110734|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
111091|NCT01930162|E2|Reported Event|Time Period From Day 3 up to End of Study|Adverse Events that occurred 48 hours post-transplant.
110735|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110736|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110737|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110738|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110739|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110740|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110741|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110742|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110743|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110744|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110745|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110746|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
111092|NCT01930162|E1|Reported Event|Time Period From Transplant Until 48hrs After Transplant|Adverse events that occurred within the first 48 hours of transplant.
110747|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110748|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110749|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110750|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110751|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110752|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110753|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110754|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110755|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110756|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110757|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110758|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
111093|NCT01930058|B4|Baseline|Total|Total of all reporting groups
111444|NCT01929031|E2|Reported Event|Caffeine|Caffeine 100mg tablet
110759|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
110760|NCT01931956|E2|Reported Event|Emergency Use|"Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.~MitraClip® implant: Percutaneous mitral valve repair using MitraClip implant"
110761|NCT01931956|E1|Reported Event|Compassionate Use|"Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.~MitraClip® implant: Percutaneous mitral valve repair using MitraClip implant"
110762|NCT01931878|B1|Baseline|All Study Participants|"The subject may be randomly assigned to receive Placebo, saline~Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is placebo, the second injections after a three month interval will be active study drug. Double blind means neither the investigators nor the subject knows which one of the two (Xeomin or placebo) is received with the first or second injections."
110763|NCT01931878|P2|Participant Flow|IncobotulinumtoxinA First, Then Placebo|"The subjects will be randomized to received injections of active study drug, incobotulinumtoxinA (Xeomin)~incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin Which is approved for use by the FDA for certain conditions. This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is Xeomin, the second injections after a three month interval will be the inactive placebo."
110764|NCT01931878|P1|Participant Flow|Placebo First, Then Incobotulinumtoxin A|Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is placebo, the second injections after a three month interval will be active study drug.
110765|NCT01931878|O2|Outcome|IncobotulinumtoxinA Treatment|incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin Which is approved for use by the FDA for certain conditions. This study has a double blind cross over design.
110766|NCT01931878|O1|Outcome|Placebo , Saline|Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo.This study has a double blind cross over design.
110767|NCT01931878|O2|Outcome|Xeomin|"The subjects will be randomized to received injections of active study drug, incobotulinumtoxinA (Xeomin)~incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin Which is approved for use by the FDA for certain conditions."
110768|NCT01931878|O1|Outcome|Placebo|"The subject may be randomly assigned to receive Placebo, saline~Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo."
110769|NCT01931878|O2|Outcome|Xeomin|incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin which is approved for use by the FDA for certain conditions. This study has a double blind cross over design.
110770|NCT01931878|O1|Outcome|Placebo|In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections.
110771|NCT01931878|E2|Reported Event|IncobotulinumtoxinA Treatment|"The subjects will be randomized to received injections of active study drug, incobotulinumtoxinA (Xeomin)~incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin Which is approved for use by the FDA for certain conditions. This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is Xeomin, the second injections after a three month interval will be the inactive placebo. Double blind means neither the investigators nor the subject knows which one of the two (Xeomin or placebo) is received with the first or second injections."
110772|NCT01931878|E1|Reported Event|Placebo , Saline|"The subject may be randomly assigned to receive Placebo, saline~Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is placebo, the second injections after a three month interval will be active study drug. Double blind means neither the investigators nor the subject knows which one of the two (Xeomin or placebo) is received with the first or second injections."
110773|NCT01931865|B1|Baseline|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites.~IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
111445|NCT01929031|E1|Reported Event|Placebo|Placebo tablet
110774|NCT01931865|P1|Participant Flow|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites.~IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
110775|NCT01931865|O1|Outcome|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites.~IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
110776|NCT01931865|O1|Outcome|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The ttoal dose will not exceed 100 units.~IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
110777|NCT01931865|O1|Outcome|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites.~IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
110778|NCT01931865|E1|Reported Event|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites.~IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
110779|NCT01931839|B8|Baseline|Total|Total of all reporting groups
110780|NCT01931839|B7|Baseline|Arm 7 Part B: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102, received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 up to Week 96.
110781|NCT01931839|B6|Baseline|Arm 6 Part B: LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102, received the same treatment in this study VX12-809-105 up to Week 96.
110782|NCT01931839|B5|Baseline|Arm 5 Part A: Observational Cohort|Participants who received either LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening OR LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening OR placebo matched to LUM and IVA in the morning and evening, in the previous study VX12-809-103 or VX12-809-104, were observed (did not receive study drug) in this study VX12-809-105 for up to 2 years.
110783|NCT01931839|B4|Baseline|Arm 4 Part A: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 or VX12-809-104, received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 up to Week 96.
110784|NCT01931839|B3|Baseline|Arm 3 Part A: LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 or VX12-809-104, received the same treatment in this study VX12-809-105 up to Week 96.
110785|NCT01931839|B2|Baseline|q12h Arm 2 Part A: Placebo - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 or VX12-809-104, received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 up to Week 96.
110786|NCT01931839|B1|Baseline|Arm 1 Part A: LUM 600 mg qd/ IVA 250 mg q12h|Participants who received lumacaftor (LUM, VX-809) 600 milligram (mg) plus ivacaftor (IVA, VX-770) 250 mg fixed-dose combination (FDC) tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 or VX12-809-104, received the same treatment in this study VX12-809-105 up to Week 96.
110787|NCT01931839|P7|Participant Flow|Arm 7 Part B: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102, received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 up to Week 96.
110788|NCT01931839|P6|Participant Flow|Arm 6 Part B: LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102, received the same treatment in this study VX12-809-105 up to Week 96.
110789|NCT01931839|P5|Participant Flow|Arm 5 Part A: Observational Cohort|Participants who received either LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening OR LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening OR placebo matched to LUM and IVA in the morning and evening, in the previous study VX12-809-103 or VX12-809-104, were observed (did not receive study drug) in this study VX12-809-105 for up to 2 years.
110790|NCT01931839|P4|Participant Flow|Arm 4 Part A: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 or VX12-809-104, received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 up to Week 96.
110791|NCT01931839|P3|Participant Flow|Arm 3 Part A: LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 or VX12-809-104, received the same treatment in this study VX12-809-105 up to Week 96.
110792|NCT01931839|P2|Participant Flow|Arm 2 Part A: Placebo - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 or VX12-809-104, received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 up to Week 96.
110793|NCT01931839|P1|Participant Flow|Arm 1 Part A: LUM 600 mg qd/ IVA 250 mg q12h|Participants who received lumacaftor (LUM, VX-809) 600 milligram (mg) plus ivacaftor (IVA, VX-770) 250 mg fixed-dose combination (FDC) tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 or VX12-809-104, received the same treatment in this study VX12-809-105 up to Week 96.
110794|NCT01931839|O1|Outcome|Arm 5: Part A Observational Cohort|Participants who received either LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening or LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening or placebo matched to LUM and IVA in the morning and evening, in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), were observed (did not receive study drug) in this study VX12-809-105 (NCT01931839) for up to 2 years.
110795|NCT01931839|O2|Outcome|Arm 7: Part B Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who were randomized to placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (NCT01225211).
110796|NCT01931839|O1|Outcome|Arm 6: Part B LUM 400 mg q12h/ IVA 250 mg q12h|Participants who were randomized to LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102 (NCT01225211).
110797|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110798|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who were randomized to LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949).
110799|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110800|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who were randomized to LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949).
110801|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110802|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who were randomized to LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949).
110803|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110804|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who were randomized to LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949).
110805|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110806|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who were randomized to LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949).
110807|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110808|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who were randomized to LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949).
110809|NCT01931839|O2|Outcome|Arm 7: Part B Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110810|NCT01931839|O1|Outcome|Arm 6: Part B LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received the same treatment in this VX12-809-105 (NCT01931839) up to Week 96.
110811|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110812|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
111094|NCT01930058|B3|Baseline|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
110813|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110814|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
110815|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110816|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
110817|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110818|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
110819|NCT01931839|O2|Outcome|Arm 7: Part B Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110820|NCT01931839|O1|Outcome|Arm 6: Part B LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received the same treatment in this VX12-809-105 (NCT01931839) up to Week 96.
110821|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110822|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
110823|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110824|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
110825|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110826|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who were randomized to LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949).
110827|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110828|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who were randomized to LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949).
110829|NCT01931839|O2|Outcome|Arm 7: Part B Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110830|NCT01931839|O1|Outcome|Arm 6: Part B LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received the same treatment in this VX12-809-105 (NCT01931839) up to Week 96.
110831|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110832|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
110930|NCT01931397|E1|Reported Event|Total Cohort|This is a prospective non randomized study. All patients were approached at the pediatric kidney transplant clinic at OHSU in a non randomized fashion until the target enrollment of 30 patients was met.
110833|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110834|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
110835|NCT01931839|O2|Outcome|Arm 7: Part B Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110836|NCT01931839|O1|Outcome|Arm 6: Part B LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received the same treatment in this VX12-809-105 (NCT01931839) up to Week 96.
110837|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110838|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
110839|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110840|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
110841|NCT01931839|O2|Outcome|Arm 7: Part B Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110842|NCT01931839|O1|Outcome|Arm 6: Part B LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received the same treatment in this VX12-809-105 (NCT01931839) up to Week 96.
110843|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110844|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
110845|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110846|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
110847|NCT01931839|O2|Outcome|Arm 7: Part B Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110848|NCT01931839|O1|Outcome|Arm 6: Part B LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received the same treatment in this VX12-809-105 (NCT01931839) up to Week 96.
110849|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110850|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
110851|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
110852|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
110931|NCT01931150|B3|Baseline|Total|Total of all reporting groups
111446|NCT01928940|B3|Baseline|Total|Total of all reporting groups
110853|NCT01931839|E7|Reported Event|Arm 7 Part B: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102, received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 up to Week 96.
110854|NCT01931839|E6|Reported Event|Arm 6 Part B: LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102, received the same treatment in this study VX12-809-105 up to Week 96.
110855|NCT01931839|E5|Reported Event|Arm 5 Part A: Observational Cohort|Participants who received either LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening OR LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening OR placebo matched to LUM and IVA in the morning and evening, in the previous study VX12-809-103 or VX12-809-104, were observed (did not receive study drug) in this study VX12-809-105 for up to 2 years.
110856|NCT01931839|E4|Reported Event|Arm 4 Part A: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 or VX12-809-104, received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 up to Week 96.
110857|NCT01931839|E3|Reported Event|Arm 3 Part A: LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 or VX12-809-104, received the same treatment in this study VX12-809-105 up to Week 96.
110858|NCT01931839|E2|Reported Event|Arm 2 Part A: Placebo - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 or VX12-809-104, received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 up to Week 96.
110859|NCT01931839|E1|Reported Event|Arm 1 Part A: LUM 600 mg qd/ IVA 250 mg q12h|Participants who received lumacaftor (LUM, VX-809) 600 milligram (mg) plus ivacaftor (IVA, VX-770) 250 mg fixed-dose combination (FDC) tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 or VX12-809-104, received the same treatment in this study VX12-809-105 up to Week 96.
110860|NCT01931709|B1|Baseline|Diagnostic (FDG PET and DCE-MRI)|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).~fludeoxyglucose F 18: Undergo FDG PET~positron emission tomography: Undergo FDG PET~dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI~laboratory biomarker analysis: Correlative studies"
110861|NCT01931709|P1|Participant Flow|Diagnostic (FDG PET and DCE-MRI)|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).~fludeoxyglucose F 18: Undergo FDG PET~positron emission tomography: Undergo FDG PET~dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI~laboratory biomarker analysis: Correlative studies"
110862|NCT01931709|O2|Outcome|Patients Without Favorable Pathologic Response|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to neoadjuvant chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).~Pathologic response at surgery rated as residual cancer burden (RCB) class II /III (moderate to extensive residual disease)."
110863|NCT01931709|O1|Outcome|Patients With Favorable Pathologic Response|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to neoadjuvant chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).~Pathologic response at surgery rated as residual cancer burden (RCB) class 0 / I (complete pathologic response or minimal residual disease)."
110864|NCT01931709|O2|Outcome|Patients Without Favorable Pathologic Response|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to neoadjuvant chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).~Pathologic response at surgery rated as residual cancer burden (RCB) class II /III (moderate to extensive residual disease)."
110865|NCT01931709|O1|Outcome|Patients With Favorable Pathologic Response|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to neoadjuvant chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).~Pathologic response at surgery rated as residual cancer burden (RCB) class 0 / I (complete pathologic response or minimal residual disease)."
110866|NCT01931709|O2|Outcome|Patients Without Favorable Pathologic Response|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to neoadjuvant chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).~Pathologic response at surgery rated as residual cancer burden (RCB) class II /III (moderate to extensive residual disease)."
110867|NCT01931709|O1|Outcome|Patients With Favorable Pathologic Response|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to neoadjuvant chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).~Pathologic response at surgery rated as residual cancer burden (RCB) class 0 / I (complete pathologic response or minimal residual disease)."
110868|NCT01931709|O1|Outcome|Diagnostic (FDG PET and DCE-MRI)|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).~fludeoxyglucose F 18: Undergo FDG PET~positron emission tomography: Undergo FDG PET~dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI~laboratory biomarker analysis: Correlative studies"
110869|NCT01931709|E1|Reported Event|Diagnostic (FDG PET and DCE-MRI)|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).~fludeoxyglucose F 18: Undergo FDG PET~positron emission tomography: Undergo FDG PET~dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI~laboratory biomarker analysis: Correlative studies"
110870|NCT01931527|B3|Baseline|Total|Total of all reporting groups
110871|NCT01931527|B2|Baseline|High Uric Acid|15 obese subjects (BMI 37.1±0.7 kg/m2) with uric acid >6mg/dL
110873|NCT01931527|P2|Participant Flow|Obese Subjects With High Uric Acid|"Subjects with a body mass index = or > 30 kg/m2 with high uric acid (>6 mg/dL)~Intervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min~Rasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min"
110874|NCT01931527|P1|Participant Flow|Obese Subjects With Normal Uric Acid|Subjects with a body mass index = or > 30 kg/m2 with normal uric acid (= or < 5 mg/dL)
110875|NCT01931527|O2|Outcome|Obese Subjects With High Uric Acid|"Subjects with a body mass index = or > 30 kg/m2 with high uric acid (>6 mg/dL)~Intervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min~Rasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min"
110876|NCT01931527|O1|Outcome|Obese Subjects With Normal Uric Acid|Subjects with a body mass index = or > 30 kg/m2 with normal uric acid (= or < 5 mg/dL)
110877|NCT01931527|O2|Outcome|Obese Subjects With High Uric Acid|"Subjects with a body mass index = or > 30 kg/m2 with high uric acid (>6 mg/dL)~Intervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min~Rasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min"
110878|NCT01931527|O1|Outcome|Obese Subjects With Normal Uric Acid|Subjects with a body mass index = or > 30 kg/m2 with normal uric acid (= or < 5 mg/dL)
110879|NCT01931527|E2|Reported Event|Obese Subjects With High Uric Acid|"Subjects with a body mass index = or > 30 kg/m2 with high uric acid (>6 mg/dL)~Intervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min~Rasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min"
110880|NCT01931527|E1|Reported Event|Obese Subjects With Normal Uric Acid|Subjects with a body mass index = or > 30 kg/m2 with normal uric acid (= or < 5 mg/dL)
110881|NCT01931475|B3|Baseline|Total|Total of all reporting groups
110882|NCT01931475|B2|Baseline|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
110883|NCT01931475|B1|Baseline|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
110884|NCT01931475|P2|Participant Flow|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment.1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
110885|NCT01931475|P1|Participant Flow|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
110886|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
110887|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
110888|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
110889|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
110890|NCT01931475|O1|Outcome|All Participants (60 mg Duloxetine & Placebo)|"Duloxetine:~Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg.~Placebo:~Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase:~1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment."
110891|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
110892|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
110893|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
110894|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
110895|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
110896|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
110897|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
110898|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
110899|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
110900|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
110901|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
110902|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
110903|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
111095|NCT01930058|B2|Baseline|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
110904|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
110905|NCT01931475|E6|Reported Event|Placebo Taper|Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs).
110906|NCT01931475|E5|Reported Event|60 mg Duloxetine Taper|1-week taper - participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs).
110907|NCT01931475|E4|Reported Event|Placebo/60 mg Duloxetine Extention|60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
110908|NCT01931475|E3|Reported Event|60 mg Duloxetine Extention|60 mg duloxetine administered by mouth QD for 13 weeks.
110909|NCT01931475|E2|Reported Event|Placebo Double Blind|Placebo administered by mouth once a day (QD) for 13 weeks.
110910|NCT01931475|E1|Reported Event|60 mg Duloxetine Double Blind|60 mg duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
110911|NCT01931462|B1|Baseline|Certus 140™|"During the operation: use of Certus 140™ microwave device for pre-coagulation of the kidney tissue adjacent to the tumor.~Microwave pre-coagulation: The Certus 140™ system is used for microwave pre-coagulation of the tissue around the part of the kidney to be removed. This is done in place of the standard clamping to stop blood loss."
110912|NCT01931462|P1|Participant Flow|Certus 140™|"During the operation: use of Certus 140™ microwave device for pre-coagulation of the kidney tissue adjacent to the tumor.~Microwave pre-coagulation: The Certus 140™ system is used for microwave pre-coagulation of the tissue around the part of the kidney to be removed. This is done in place of the standard clamping to stop blood loss."
110913|NCT01931462|O1|Outcome|Certus 140™|"During the operation: use of Certus 140™ microwave device for pre-coagulation of the kidney tissue adjacent to the tumor.~Microwave pre-coagulation: The Certus 140™ system is used for microwave pre-coagulation of the tissue around the part of the kidney to be removed. This is done in place of the standard clamping to stop blood loss."
110914|NCT01931462|O1|Outcome|Certus 140™|"During the operation: use of Certus 140™ microwave device for pre-coagulation of the kidney tissue adjacent to the tumor.~Microwave pre-coagulation: The Certus 140™ system is used for microwave pre-coagulation of the tissue around the part of the kidney to be removed. This is done in place of the standard clamping to stop blood loss."
110915|NCT01931462|O1|Outcome|Certus 140™|"During the operation: use of Certus 140™ microwave device for pre-coagulation of the kidney tissue adjacent to the tumor.~Microwave pre-coagulation: The Certus 140™ system is used for microwave pre-coagulation of the tissue around the part of the kidney to be removed. This is done in place of the standard clamping to stop blood loss."
110916|NCT01931462|O1|Outcome|Certus 140™|"During the operation: use of Certus 140™ microwave device for pre-coagulation of the kidney tissue adjacent to the tumor.~Microwave pre-coagulation: The Certus 140™ system is used for microwave pre-coagulation of the tissue around the part of the kidney to be removed. This is done in place of the standard clamping to stop blood loss."
110917|NCT01931462|O1|Outcome|Certus 140™|"During the operation: use of Certus 140™ microwave device for pre-coagulation of the kidney tissue adjacent to the tumor.~Microwave pre-coagulation: The Certus 140™ system is used for microwave pre-coagulation of the tissue around the part of the kidney to be removed. This is done in place of the standard clamping to stop blood loss."
110918|NCT01931462|O1|Outcome|Certus 140™|"During the operation: use of Certus 140™ microwave device for pre-coagulation of the kidney tissue adjacent to the tumor.~Microwave pre-coagulation: The Certus 140™ system is used for microwave pre-coagulation of the tissue around the part of the kidney to be removed. This is done in place of the standard clamping to stop blood loss."
110919|NCT01931462|O1|Outcome|Certus 140™|"During the operation: use of Certus 140™ microwave device for pre-coagulation of the kidney tissue adjacent to the tumor.~Microwave pre-coagulation: The Certus 140™ system is used for microwave pre-coagulation of the tissue around the part of the kidney to be removed. This is done in place of the standard clamping to stop blood loss."
110920|NCT01931462|O1|Outcome|Certus 140™|"During the operation: use of Certus 140™ microwave device for pre-coagulation of the kidney tissue adjacent to the tumor.~Microwave pre-coagulation: The Certus 140™ system is used for microwave pre-coagulation of the tissue around the part of the kidney to be removed. This is done in place of the standard clamping to stop blood loss."
110921|NCT01931462|E1|Reported Event|Certus 140™|"During the operation: use of Certus 140™ microwave device for pre-coagulation of the kidney tissue adjacent to the tumor.~Microwave pre-coagulation: The Certus 140™ system is used for microwave pre-coagulation of the tissue around the part of the kidney to be removed. This is done in place of the standard clamping to stop blood loss."
110922|NCT01931397|B1|Baseline|Total Cohort|This is a prospective non randomized study. All patients were approached at the pediatric kidney transplant clinic at OHSU in a non randomized fashion until the target enrollment of 30 patients was met.
110923|NCT01931397|P1|Participant Flow|Total Cohort|This is a prospective non randomized study. All patients were approached at the pediatric kidney transplant clinic at OHSU in a non randomized fashion until the target enrollment of 30 patients was met.
110924|NCT01931397|O1|Outcome|Total Cohort|This is a prospective non randomized study. All patients were approached at the pediatric kidney transplant clinic at OHSU in a non randomized fashion until the target enrollment of 30 patients was met.
110925|NCT01931397|O2|Outcome|Group 2|Participants less than 12 years of age
110926|NCT01931397|O1|Outcome|Group 1|Participants 12 years and over
110927|NCT01931397|O2|Outcome|At End of Study|Numbers of families at end of study
110928|NCT01931397|O1|Outcome|At Time of Enrollment|Number of families at enrollment
111096|NCT01930058|B1|Baseline|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
110932|NCT01931150|B2|Baseline|Dapsone RIGHT, Moisturizer LEFT|Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.
110933|NCT01931150|B1|Baseline|Dapsone LEFT, Moisturizer RIGHT|Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.
110934|NCT01931150|P2|Participant Flow|Dapsone RIGHT, Moisturizer LEFT|Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.
110935|NCT01931150|P1|Participant Flow|Dapsone LEFT, Moisturizer RIGHT|Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.
110936|NCT01931150|O2|Outcome|Dapsone RIGHT, Moisturizer LEFT|Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.
110937|NCT01931150|O1|Outcome|Dapsone LEFT, Moisturizer RIGHT|Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.
110938|NCT01931150|E2|Reported Event|Dapsone RIGHT, Moisturizer LEFT|Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.
110939|NCT01931150|E1|Reported Event|Dapsone LEFT, Moisturizer RIGHT|Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.
110940|NCT01931059|B3|Baseline|Total|Total of all reporting groups
110941|NCT01931059|B2|Baseline|Placebo Then Risperidone|"This group will receive a placebo on the first day and 2mg (> 200lbs.), 1.5mg (150-200lbs), or 1 mg (<150lbs.) of risperidone oral solution on the second day~Risperidone"
110942|NCT01931059|B1|Baseline|Risperidone Then Placebo|"This group will receive 2 mg (>200lbs), 1.5mg (150-200lbs.) or 1 mg (< 150lbs. of risperidone oral solution on the first day and a placebo on the second day.~Risperidone"
110943|NCT01931059|P2|Participant Flow|Placebo Then Risperidone|This group will receive a placebo on the first day and 2mg (> 200lbs.), 1.5mg (150-200lbs), or 1 mg (<150lbs.) of risperidone oral solution on the second day, on the third day they did not receive anything.
110944|NCT01931059|P1|Participant Flow|Risperidone Then Placebo|This group will receive 2 mg (>200lbs), 1.5mg (150-200lbs.) or 1 mg (< 150lbs. of risperidone oral solution on the first day and a placebo on the second day, on third day they did not receive anything.
110945|NCT01931059|O4|Outcome|OFF - REWARD|Subject's performance after placebo administration in the reward part of the task
110946|NCT01931059|O3|Outcome|ON - REWARD|Subject's performance during the peak of the risperidone effect in the reward part of the task
110947|NCT01931059|O2|Outcome|OFF - PUNISHMENT|Subject's performance after placebo administration.
110948|NCT01931059|O1|Outcome|ON - PUNISHMENT|Subject's performance during the peak of the risperidone effect in the punishment part of the task
110949|NCT01931059|O2|Outcome|Placebo Then Risperidone|"This group will receive a placebo on the first day and 2mg (> 200lbs.), 1.5mg (150-200lbs), or 1 mg (<150lbs.) of risperidone oral solution on the second day~Risperidone: We gave oral liquid of risperidone one time 1-2 mg depending on subject's weight.~Placebo: We gave oral liquid without active risperidone (pt and provider were both double blinded)"
110950|NCT01931059|O1|Outcome|Risperidone Then Placebo|"This group will receive 2 mg (>200lbs), 1.5mg (150-200lbs.) or 1 mg (< 150lbs. of risperidone oral solution on the first day and a placebo on the second day.~Risperidone: We gave oral liquid of risperidone one time 1-2 mg depending on subject's weight.~Placebo: We gave oral liquid without active risperidone (pt and provider were both double blinded)"
110951|NCT01931059|O2|Outcome|Placebo Then Risperidone|"This group will receive a placebo on the first day and 2mg (> 200lbs.), 1.5mg (150-200lbs), or 1 mg (<150lbs.) of risperidone oral solution on the second day~Risperidone"
110952|NCT01931059|O1|Outcome|Risperidone Then Placebo|"This group will receive 2 mg (>200lbs), 1.5mg (150-200lbs.) or 1 mg (< 150lbs. of risperidone oral solution on the first day and a placebo on the second day.~Risperidone"
110953|NCT01931059|E2|Reported Event|Placebo Then Risperidone|"This group will receive a placebo on the first day and 2mg (> 200lbs.), 1.5mg (150-200lbs), or 1 mg (<150lbs.) of risperidone oral solution on the second day~Risperidone"
110954|NCT01931059|E1|Reported Event|Risperidone Then Placebo|"This group will receive 2 mg (>200lbs), 1.5mg (150-200lbs.) or 1 mg (< 150lbs. of risperidone oral solution on the first day and a placebo on the second day.~Risperidone"
110955|NCT01930890|B5|Baseline|Total|Total of all reporting groups
110956|NCT01930890|B4|Baseline|BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
110957|NCT01930890|B3|Baseline|Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
110958|NCT01930890|B2|Baseline|BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
110959|NCT01930890|B1|Baseline|Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
110960|NCT01930890|P4|Participant Flow|BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
111081|NCT01930435|O1|Outcome|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device: This is a personal humidification device. It is hand held and produces sterile warm vapor."
110961|NCT01930890|P3|Participant Flow|Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
110962|NCT01930890|P2|Participant Flow|BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
110963|NCT01930890|P1|Participant Flow|Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus mycophenolate mofetil (MMF) and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg intavenously (IV) Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
110964|NCT01930890|O4|Outcome|BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
110965|NCT01930890|O3|Outcome|Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
110966|NCT01930890|O2|Outcome|BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
110967|NCT01930890|O1|Outcome|Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
110968|NCT01930890|O4|Outcome|BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
110969|NCT01930890|O3|Outcome|Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
110970|NCT01930890|O2|Outcome|BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
110971|NCT01930890|O1|Outcome|Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
110972|NCT01930890|E4|Reported Event|BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
110973|NCT01930890|E3|Reported Event|Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received placebo every Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
110974|NCT01930890|E2|Reported Event|BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
110975|NCT01930890|E1|Reported Event|Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received placebo Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
110976|NCT01930799|B1|Baseline|All Enrolled Patients|Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
110977|NCT01930799|P1|Participant Flow|All Enrolled Patients|Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
110978|NCT01930799|O1|Outcome|All Enrolled Patients|Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
110979|NCT01930799|O1|Outcome|All Enrolled Patients|Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
110980|NCT01930799|E1|Reported Event|All Enrolled Patients|Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
110981|NCT01930487|B1|Baseline|Participants Completing Study|Participants who completed both arms of the crossover study
110982|NCT01930487|P2|Participant Flow|Placebo, Then Supplement With Antioxidants|placebo supplement in the second intervention period, followed by dietary supplement with antioxidants in the second intervention period
110983|NCT01930487|P1|Participant Flow|Supplement With Antioxidants, Then Placebo|dietary supplement with antioxidants in the first intervention period, followed by placebo supplement in the second intervention period
110984|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
110985|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
110986|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
110987|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
110988|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
110989|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
110990|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
110991|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
110992|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
110993|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
110994|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
110995|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
110996|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
110997|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
110998|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
110999|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111000|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111001|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111002|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111003|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111004|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111005|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111006|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111007|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111008|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111009|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111010|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111011|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111012|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111013|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111014|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111015|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111016|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111017|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111018|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111082|NCT01930435|O1|Outcome|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device"
111019|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111020|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111021|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111022|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111023|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111024|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111025|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111026|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111027|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111028|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111029|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111030|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111031|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111032|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111033|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111034|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111035|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111036|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111037|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111038|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111039|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111040|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111041|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111042|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111043|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111044|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111045|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111046|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111047|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111048|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111083|NCT01930435|E1|Reported Event|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device"
111049|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111050|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111051|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111052|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111053|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111054|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111055|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111056|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111057|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111058|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111059|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111060|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111061|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111062|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111063|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111064|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111065|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111066|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111067|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111068|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111069|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111070|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111071|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111072|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
111073|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111074|NCT01930487|E2|Reported Event|Placebo|"placebo supplement~Placebo: Placebo - Softgels manufactured to mimic the appearance of active, dietary supplement with antioxidants"
111075|NCT01930487|E1|Reported Event|Supplement w/ Antioxidants|"dietary supplement with antioxidants~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
111076|NCT01930435|B1|Baseline|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device"
111077|NCT01930435|P1|Participant Flow|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device"
111078|NCT01930435|O1|Outcome|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device"
111079|NCT01930435|O1|Outcome|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device"
111080|NCT01930435|O1|Outcome|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device"
111097|NCT01930058|P3|Participant Flow|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
111098|NCT01930058|P2|Participant Flow|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
111099|NCT01930058|P1|Participant Flow|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 once daily (q.d.) by mouth for 7 days.
111100|NCT01930058|O3|Outcome|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
111101|NCT01930058|O2|Outcome|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
111102|NCT01930058|O1|Outcome|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
111103|NCT01930058|O3|Outcome|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
111104|NCT01930058|O2|Outcome|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
111105|NCT01930058|O1|Outcome|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
111106|NCT01930058|O3|Outcome|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
111107|NCT01930058|O2|Outcome|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
111108|NCT01930058|O1|Outcome|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
111109|NCT01930058|O3|Outcome|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
111110|NCT01930058|O2|Outcome|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
111111|NCT01930058|O1|Outcome|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
111112|NCT01930058|O3|Outcome|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
111113|NCT01930058|O2|Outcome|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
111114|NCT01930058|O1|Outcome|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
111115|NCT01930058|O3|Outcome|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
111116|NCT01930058|O2|Outcome|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
111117|NCT01930058|O1|Outcome|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
111118|NCT01930058|E2|Reported Event|MK-8876 800 mg|All HCV GT1a and GT3 participants treated with MK-8876 800 mg are included.
111119|NCT01930058|E1|Reported Event|MK-8876 150 mg|All HCV GT3 participants treated with MK-8876 150 mg are included.
111120|NCT01930045|B1|Baseline|All Participants|All enrolled participants
111121|NCT01930045|P6|Participant Flow|Ralt4MAL-MAL4Ralt-Ralt-Ralt6MAL-MAL6Ralt|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Ralt followed 4 hrs later by MAL in Period 1, MAL followed 4 hrs later by Ralt in Period 2, Ralt alone in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5
111122|NCT01930045|P5|Participant Flow|MAL4Ralt-Ralt-Ralt4MAL-Ralt6MAL-MAL6Ralt|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: MAL followed 4 hrs later by Ralt in Period 1, Ralt alone in Period 2, Ralt followed 4 hrs later by MAL in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5
111123|NCT01930045|P4|Participant Flow|Ralt-Ralt4MAL-MAL4Ralt-Ralt6MAL-MAL6Ralt|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Ralt alone in Period 1, Ralt followed 4 hrs later by MAL in Period 2, MAL followed 4 hrs later by Ralt in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5
111124|NCT01930045|P3|Participant Flow|Ralt4MAL-Ralt-MAL4Ralt-MAL6Ralt-Ralt6MAL|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Ralt followed 4 hrs later by MAL in Period 1, Ralt alone in Period 2, MAL followed 4 hrs later by Ralt in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
111125|NCT01930045|P2|Participant Flow|MAL4Ralt-Ralt4MAL-Ralt-MAL6Ralt-Ralt6MAL|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: MAL followed 4 hrs later by Ralt in Period 1, Ralt followed 4 hrs later by MAL in Period 2, Ralt alone in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
111126|NCT01930045|P1|Participant Flow|Ralt-MAL4Ralt-Ralt4MAL-MAL6Ralt-Ralt6MAL|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Raltegravir (Ralt) alone in Period 1, MAALOX (MAL) followed 4 hrs later by Ralt in Period 2, Ralt followed 4 hrs later by MAL in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
111127|NCT01930045|O3|Outcome|Raltegravir → 6 Hours → Maalox|400 mg Raltegravir followed 6 hrs later by 20 mL Maalox
111128|NCT01930045|O2|Outcome|Maalox → 6 Hours → Raltegravir|20 mL Maalox followed 6 hrs later by 400 mg Raltegravir
111129|NCT01930045|O1|Outcome|Raltegravir|400 mg Raltegravir alone
127144|NCT01852162|O2|Outcome|Placebo|Placebo tablets
111131|NCT01930045|O2|Outcome|Maalox → 6 Hours → Raltegravir|20 mL Maalox followed 6 hrs later by 400 mg Raltegravir
111132|NCT01930045|O1|Outcome|Raltegravir|400 mg Raltegravir alone
111133|NCT01930045|O3|Outcome|Raltegravir → 6 Hours → Maalox|400 mg Raltegravir followed 6 hrs later by 20 mL Maalox
111134|NCT01930045|O2|Outcome|Maalox → 6 Hours → Raltegravir|20 mL Maalox followed 6 hrs later by 400 mg Raltegravir
111135|NCT01930045|O1|Outcome|Raltegravir|400 mg Raltegravir alone
111136|NCT01930045|O3|Outcome|Raltegravir → 4 Hours → Maalox|400 mg Raltegravir followed 4 hrs later by 20 mL Maalox
111137|NCT01930045|O2|Outcome|Maalox → 4 Hours → Raltegravir|20 mL Maalox followed 4 hrs later by 400 mg Raltegravir
111138|NCT01930045|O1|Outcome|Raltegravir|400 mg Raltegravir alone
111139|NCT01930045|O3|Outcome|Raltegravir → 4 Hours → Maalox|400 mg Raltegravir followed 4 hrs later by 20 mL Maalox
111140|NCT01930045|O2|Outcome|Maalox → 4 Hours → Raltegravir|20 mL Maalox followed 4 hrs later by 400 mg Raltegravir
111141|NCT01930045|O1|Outcome|Raltegravir|400 mg Raltegravir alone
111142|NCT01930045|O3|Outcome|Raltegravir → 4 Hours → Maalox|400 mg Raltegravir followed 4 hrs later by 20 mL Maalox
111143|NCT01930045|O2|Outcome|Maalox → 4 Hours → Raltegravir|20 mL Maalox followed 4 hrs later by 400 mg Raltegravir
111144|NCT01930045|O1|Outcome|Raltegravir|400 mg Raltegravir alone
111145|NCT01930045|E5|Reported Event|Raltegravir → 6 Hours → Maalox|400 mg Raltegravir followed 6 hrs later by 20 mL Maalox
111146|NCT01930045|E4|Reported Event|Maalox → 6 Hours → Raltegravir|20 mL Maalox followed 6 hrs later by 400 mg Raltegravir
111147|NCT01930045|E3|Reported Event|Raltegravir → 4 Hours → Maalox|400 mg Raltegravir followed 4 hrs later by 20 mL Maalox
111148|NCT01930045|E2|Reported Event|Maalox → 4 Hours → Raltegravir|20 mL Maalox followed 4 hrs later by 400 mg Raltegravir
111149|NCT01930045|E1|Reported Event|Raltegravir|400 mg Raltegravir alone
111150|NCT01929993|B3|Baseline|Total|Total of all reporting groups
111151|NCT01929993|B2|Baseline|Large Loop Excision of the Transformation Zone (LLETZ-cone)|Large loop excision of the Transformation Zone (LLETZ-cone) is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin.
111152|NCT01929993|B1|Baseline|Straight Wire Excision of Transformation Zone (SWETZ)|Straight wire excision of transformation zone (SWETZ) is an electrosurgical conization method, which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix.
111153|NCT01929993|P2|Participant Flow|Large Loop Excision of the Transformation Zone (LLETZ-cone)|Large Loop Excision of the Transformation Zone (LLETZ-cone) is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin.
111154|NCT01929993|P1|Participant Flow|Straight Wire Excision of Transformation Zone (SWETZ)|Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode to remove the dysplastic epithelium of the cervix.
111155|NCT01929993|O2|Outcome|LLETZ Cone|"LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth.~LLETZ cone: LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin."
111156|NCT01929993|O1|Outcome|SWETZ|"Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode.~SWETZ: Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix."
111157|NCT01929993|E2|Reported Event|LLETZ Cone|"LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth.~LLETZ cone: LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin."
111158|NCT01929993|E1|Reported Event|SWETZ|"Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode.~SWETZ: Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix."
111159|NCT01929980|B1|Baseline|Bortezomib|"Four doses of bortezomib, 1.3mg/m2, will be given intravenously (through a needle in a vein) or subcutaneously (under the skin) on Days 1, 4, 8, 11.~The format of receiving medications is- Therapy Dose and Route Frequency Rituximab 375 mg/m2 intravenously Once on day 1. Plasmapheresis 2 hours prior to Bortezomib Day 1,4, 8 and 11 Bortezomib 1.3 mg/m2 intravenously Day 1,4,8 and 11~Bortezomib"
111160|NCT01929980|P1|Participant Flow|Bortezomib|"Four doses of bortezomib, 1.3mg/m2, will be given intravenously (through a needle in a vein) or subcutaneously (under the skin) on Days 1, 4, 8, 11.~The format of receiving medications is- Therapy Dose and Route Frequency Rituximab 375 mg/m2 intravenously Once on day 1. Plasmapheresis 2 hours prior to Bortezomib Day 1,4, 8 and 11 Bortezomib 1.3 mg/m2 intravenously Day 1,4,8 and 11~Bortezomib"
111161|NCT01929980|O1|Outcome|Bortezomib|"Four doses of bortezomib, 1.3mg/m2, will be given intravenously (through a needle in a vein) or subcutaneously (under the skin) on Days 1, 4, 8, 11.~The format of receiving medications is- Therapy Dose and Route Frequency Rituximab 375 mg/m2 intravenously Once on day 1. Plasmapheresis 2 hours prior to Bortezomib Day 1,4, 8 and 11 Bortezomib 1.3 mg/m2 intravenously Day 1,4,8 and 11~Bortezomib"
111162|NCT01929980|E1|Reported Event|Bortezomib|"Four doses of bortezomib, 1.3mg/m2, will be given intravenously (through a needle in a vein) or subcutaneously (under the skin) on Days 1, 4, 8, 11.~The format of receiving medications is- Therapy Dose and Route Frequency Rituximab 375 mg/m2 intravenously Once on day 1. Plasmapheresis 2 hours prior to Bortezomib Day 1,4, 8 and 11 Bortezomib 1.3 mg/m2 intravenously Day 1,4,8 and 11~Bortezomib"
111227|NCT01929759|O1|Outcome|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.~Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
111163|NCT01929889|B1|Baseline|Iloperidone|Patients currently taking an antipsychotic medication other than Fanapt® will switch from their current medicine to Fanapt® in a cross-titration at a rate that is determined by the study physician. Treatment with iloperidone will be initiated and dosage will increase until the subject has achieved clinical stability, or has achieved the maximum dose, or 8 weeks have elapsed. Subjects who do not achieve clinical stability (as defined in the inclusion criteria) for the final 2 weeks in this 8-week period at the maximum dose of iloperidone will be discontinued from the study. If patients achieve stabilization, the lowest effective dose will be maintained. Subjects who have achieved clinical stability will then enter the 12-week treatment phase of the study.
111164|NCT01929889|P1|Participant Flow|A Single Arm, Open Label, Exploratory Study|This is a single arm, open label, exploratory study to examine effects of Fanapt (iloperadone) on social cognition. Patients currently taking an antipsychotic medication other than Fanapt® will switch from their current medicine to Fanapt® in a cross-titration at a rate that is determined by the study physician. Treatment with iloperidone will be initiated and dosage will increase until the subject has achieved clinical stability, or has achieved the maximum dose, or 8 weeks have elapsed. Subjects who do not achieve clinical stability (as defined in the inclusion criteria) for the final 2 weeks in this 8-week period at the maximum dose of iloperidone will be discontinued from the study. If patients achieve stabilization, the lowest effective dose will be maintained. Subjects who have achieved clinical stability will then enter the 12-week treatment phase of the study.
111165|NCT01929889|O1|Outcome|Iloperidone|Patients currently taking an antipsychotic medication other than Fanapt® will switch from their current medicine to Fanapt® in a cross-titration at a rate that is determined by the study physician. Treatment with iloperidone will be initiated and dosage will increase until the subject has achieved clinical stability, or has achieved the maximum dose, or 8 weeks have elapsed. Subjects who do not achieve clinical stability (as defined in the inclusion criteria) for the final 2 weeks in this 8-week period at the maximum dose of iloperidone will be discontinued from the study. If patients achieve stabilization, the lowest effective dose will be maintained. Subjects who have achieved clinical stability will then enter the 12-week treatment phase of the study.
111166|NCT01929889|E1|Reported Event|Iloperidone|Patients currently taking an antipsychotic medication other than Fanapt® will switch from their current medicine to Fanapt® in a cross-titration at a rate that is determined by the study physician. Treatment with iloperidone will be initiated and dosage will increase until the subject has achieved clinical stability, or has achieved the maximum dose, or 8 weeks have elapsed. Subjects who do not achieve clinical stability (as defined in the inclusion criteria) for the final 2 weeks in this 8-week period at the maximum dose of iloperidone will be discontinued from the study. If patients achieve stabilization, the lowest effective dose will be maintained. Subjects who have achieved clinical stability will then enter the 12-week treatment phase of the study.
111167|NCT01929876|B1|Baseline|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
111168|NCT01929876|P1|Participant Flow|Cobimetinib + Itraconazole|Cobimetinib 10 milligram (mg) (two 5 mg capsules) administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
111169|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
111170|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
111171|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
111172|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
111173|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
111174|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
111175|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
111176|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
111177|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
111178|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
111179|NCT01929876|E1|Reported Event|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
111192|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111180|NCT01929863|B1|Baseline|All Study Participants|In each treatment period, participants received oral dose of treatment A-metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 or oral dose of treatment B-metformin 850 mg tablet BID plus matchig placebo to GSK2330672 tablet BID for 7 days according to a plan of randomization. The two treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111181|NCT01929863|P2|Participant Flow|Placebo and Metformin, Then Metformin and GSK2330672|Participants received oral dose of treatment B-metformin 850 mg tablet BID plus matching placebo to GSK2330672 tablet BID for 7 days according to a plan of randomization. After a washout period of 13 to 15 days, participants received oral dose of treatment A-metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7. During the washout period, participants received metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111182|NCT01929863|P1|Participant Flow|Metformin and GSK2330672, Then Placebo and Metformin|Participants received oral dose of treatment A-metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 according to a plan of randomization. After a washout period of 13 to 15 days, participants received oral dose of treatment B-metformin 850 mg tablet BID plus matching placebo to GSK2330672 tablet BID for 7 days. During the washout period, participants received metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111183|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111184|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111185|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111186|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111187|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111188|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111189|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111190|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111191|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111426|NCT01929031|O4|Outcome|Ibuprofen/Caffeine|One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery
111193|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111194|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111195|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111196|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111197|NCT01929863|O3|Outcome|Follow-up-Metformin|After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111198|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
111199|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
111200|NCT01929863|O3|Outcome|Follow-up-Metformin|After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111201|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matchig placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
111202|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
111203|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matchig placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111204|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111205|NCT01929863|O3|Outcome|Follow-up-Metformin|After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111206|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
111207|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
111208|NCT01929863|O3|Outcome|Follow-up-Metformin|After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111209|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
111427|NCT01929031|O3|Outcome|Ibuprofen|One Ibuprofen 400mg tablet after dental surgery
111210|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
111211|NCT01929863|O3|Outcome|Follow-up-Metformin|After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111212|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
111213|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
111214|NCT01929863|O3|Outcome|Follow-up-Metformin|After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111215|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
111216|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
111217|NCT01929863|O3|Outcome|Follow-up-Metformin|After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111218|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
111219|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
111220|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111221|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111222|NCT01929863|E2|Reported Event|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
111223|NCT01929863|E1|Reported Event|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up
111224|NCT01929759|B1|Baseline|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.~Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
111225|NCT01929759|P1|Participant Flow|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.~Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
111226|NCT01929759|O1|Outcome|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.~Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
111274|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
127145|NCT01852162|O1|Outcome|Dabigatran|Dabigatran 150mg
111228|NCT01929759|O1|Outcome|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.~Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
111229|NCT01929759|O1|Outcome|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.~Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
111230|NCT01929759|O1|Outcome|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.~Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
111231|NCT01929759|O1|Outcome|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.~Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
111232|NCT01929759|O1|Outcome|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.~Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
111233|NCT01929759|O1|Outcome|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.~Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
111234|NCT01929759|O1|Outcome|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.~Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
111235|NCT01929759|E1|Reported Event|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.~Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
111236|NCT01929681|B3|Baseline|Total|Total of all reporting groups
111237|NCT01929681|B2|Baseline|LFMS - Sham Treatment|"Low Field Magnetic Stimulation - sham treatment~Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.~Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
111238|NCT01929681|B1|Baseline|LFMS - Active Treatment|"Low Field Magnetic Stimulation (LFMS) active treatment~Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.~Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
111239|NCT01929681|P2|Participant Flow|LFMS - Sham Treatment|"Low Field Magnetic Stimulation - sham treatment~Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.~Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
111240|NCT01929681|P1|Participant Flow|LFMS - Active Treatment|"Low Field Magnetic Stimulation (LFMS) active treatment~Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.~Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
111241|NCT01929681|O2|Outcome|LFMS - Sham Treatment|"Low Field Magnetic Stimulation - sham treatment~Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.~Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
111242|NCT01929681|O1|Outcome|LFMS - Active Treatment|"Low Field Magnetic Stimulation (LFMS) active treatment~Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.~Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
111243|NCT01929681|O2|Outcome|LFMS - Sham Treatment|"Low Field Magnetic Stimulation - sham treatment~Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.~Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
111244|NCT01929681|O1|Outcome|LFMS - Active Treatment|"Low Field Magnetic Stimulation (LFMS) active treatment~Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.~Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
111245|NCT01929681|O2|Outcome|LFMS - Sham Treatment|"Low Field Magnetic Stimulation - sham treatment~Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.~Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
111246|NCT01929681|O1|Outcome|LFMS - Active Treatment|"Low Field Magnetic Stimulation (LFMS) active treatment~Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.~Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
111275|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
111247|NCT01929681|O2|Outcome|LFMS - Sham Treatment|"Low Field Magnetic Stimulation - sham treatment~Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.~Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
111248|NCT01929681|O1|Outcome|LFMS - Active Treatment|"Low Field Magnetic Stimulation (LFMS) active treatment~Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.~Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
111249|NCT01929681|O2|Outcome|LFMS - Sham Treatment|"Low Field Magnetic Stimulation - sham treatment~Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.~Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
111250|NCT01929681|O1|Outcome|LFMS - Active Treatment|"Low Field Magnetic Stimulation (LFMS) active treatment~Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.~Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
111251|NCT01929681|E2|Reported Event|LFMS - Sham Treatment|"Low Field Magnetic Stimulation - sham treatment~Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.~Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
111252|NCT01929681|E1|Reported Event|LFMS - Active Treatment|"Low Field Magnetic Stimulation (LFMS) active treatment~Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.~Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
111253|NCT01929473|B1|Baseline|Blood Drawings (0 Day, 365 Day) and Questionnaires|
111254|NCT01929473|P1|Participant Flow|Blood Drawings (0 Day, 365 Day) and Questionnaires|
111255|NCT01929473|O1|Outcome|Blood Drawings (0 Day, 365 Day) and Questionnaires|
111256|NCT01929473|E1|Reported Event|Blood Drawings (0 Day, 365 Day) and Questionnaires|
111257|NCT01929460|B3|Baseline|Total|Total of all reporting groups
111258|NCT01929460|B2|Baseline|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
111259|NCT01929460|B1|Baseline|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
111260|NCT01929460|P2|Participant Flow|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their Endoscopic Ultrasound (EUS)-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
111261|NCT01929460|P1|Participant Flow|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their Endoscopic Ultrasound (EUS)-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
111262|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
111263|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
111264|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
111265|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
111266|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
111267|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
111268|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
111269|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
111270|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
111271|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
111272|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
111273|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
111428|NCT01929031|O2|Outcome|Caffeine|One Caffeine 100mg tablet after dental surgery
111429|NCT01929031|O1|Outcome|Placebo|One Placebo tablet after dental surgery
111276|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
111277|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
111278|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
111279|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
111280|NCT01929460|E2|Reported Event|Intervention Group|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
111281|NCT01929460|E1|Reported Event|Drug (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
111282|NCT01929317|B3|Baseline|Total|Total of all reporting groups
111283|NCT01929317|B2|Baseline|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111284|NCT01929317|B1|Baseline|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111285|NCT01929317|P2|Participant Flow|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg per day administered orally OD for 4 weeks in the Screening phase. After randomization, participants entered the Dose Increase Effect Verification Phase, where ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. After the completion of the Dose Increase Effect Verification Phase, participants entered the Down Titration Phase for 1 week and selected participants entered the Long-term Phase for 39 weeks.
111286|NCT01929317|P1|Participant Flow|Ropinirole CR - High Dose Group|Participants received ropinirole controlled released (CR) 16 milligrams (mg) administered orally once daily (OD) for 4 weeks in the Screening Phase. After randomization, participants entered the Dose Increase Effect Verification Phase, where ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24 mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. After the completion of the Dose Increase Effect Verification Phase, participants entered the Down Titration Phase for 1 week and selected participants entered the Long-term Phase for 39 weeks.
111287|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111288|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111355|NCT01929135|P2|Participant Flow|Placebo Group|A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a non-medicated dentifrice as placebo 2 times a day for two minutes each time, for 30 days.
111430|NCT01929031|O4|Outcome|Ibuprofen/Caffeine|One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery
111289|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111290|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111291|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111292|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111293|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111294|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111295|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111356|NCT01929135|P1|Participant Flow|Atorvastatin Group|A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a medicated 2% atorvastatin dentifrice 2 times a day for two minutes each time for a period of 30 days..
111357|NCT01929135|O2|Outcome|Placebo Group|A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a non-medicated dentifrice as placebo 2 times a day for two minutes each time, for 30 days.
111296|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111297|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111298|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111299|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111300|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111301|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111302|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111358|NCT01929135|O1|Outcome|Atorvastatin Group|"A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.~Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days."
111431|NCT01929031|O3|Outcome|Ibuprofen|One Ibuprofen 400mg tablet after dental surgery
111432|NCT01929031|O2|Outcome|Caffeine|One Caffeine 100mg tablet after dental surgery
111303|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111304|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111305|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111306|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111307|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111308|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111309|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111359|NCT01929135|O2|Outcome|Non Medicated Gel Toothpaste|"A group of 19 patients will receive a toothpaste without the drug to act as a placebo.Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste that will be provided, 2 times a day for two minutes each time, for 30 days.~Non medicated gel toothpaste: Normal gel toothpaste used as placebo, brushing 1 minute 2 time a day, for 30 days."
111433|NCT01929031|O1|Outcome|Placebo|One Placebo tablet after dental surgery
111434|NCT01929031|O4|Outcome|Ibuprofen/Caffeine|One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery
111310|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111311|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111312|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111313|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111314|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111315|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111316|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111360|NCT01929135|O1|Outcome|Atorvastatin Toothpaste|"A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.~Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days."
111435|NCT01929031|O3|Outcome|Ibuprofen|One Ibuprofen 400mg tablet after dental surgery
111436|NCT01929031|O2|Outcome|Caffeine|One Caffeine 100mg tablet after dental surgery
111317|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111318|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111319|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111320|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111321|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111322|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111323|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111361|NCT01929135|O2|Outcome|Non Medicated Gel Toothpaste|"A group of 19 patients will receive a toothpaste without the drug to act as a placebo.Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste that will be provided, 2 times a day for two minutes each time, for 30 days.~Non medicated gel toothpaste: Normal gel toothpaste used as placebo, brushing 1 minute 2 time a day, for 30 days."
111437|NCT01929031|O1|Outcome|Placebo|One Placebo tablet after dental surgery
112723|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
111324|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111325|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111326|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111327|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111328|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111329|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111330|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111362|NCT01929135|O1|Outcome|Atorvastatin Toothpaste|"A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.~Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days."
111438|NCT01929031|O4|Outcome|Ibuprofen/Caffeine|One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery
111439|NCT01929031|O3|Outcome|Ibuprofen|One Ibuprofen 400mg tablet after dental surgery
111331|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111332|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111333|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111334|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111335|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111336|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111337|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111363|NCT01929135|O2|Outcome|Non Medicated Gel Toothpaste|"A group of 19 patients will receive a toothpaste without the drug to act as a placebo.Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste that will be provided, 2 times a day for two minutes each time, for 30 days.~Non medicated gel toothpaste: Normal gel toothpaste used as placebo, brushing 1 minute 2 time a day, for 30 days."
111440|NCT01929031|O2|Outcome|Caffeine|One Caffeine 100mg tablet after dental surgery
111441|NCT01929031|O1|Outcome|Placebo|One Placebo tablet after dental surgery
111338|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111339|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111340|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111341|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111342|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111343|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111344|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111364|NCT01929135|O1|Outcome|Atorvastatin Toothpaste|"A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.~Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days."
111391|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
111345|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111346|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111347|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111348|NCT01929317|E4|Reported Event|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111349|NCT01929317|E3|Reported Event|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111350|NCT01929317|E2|Reported Event|Ropinirole CR - Maintenance Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111351|NCT01929317|E1|Reported Event|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
111352|NCT01929135|B3|Baseline|Total|Total of all reporting groups
111353|NCT01929135|B2|Baseline|Placebo Group|A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a non-medicated dentifrice as placebo 2 times a day for two minutes each time, for 30 days.
111354|NCT01929135|B1|Baseline|Atorvastatin Group|A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a medicated 2% atorvastatin dentifrice 2 times a day for two minutes each time for a period of 30 days.
111365|NCT01929135|O2|Outcome|Non Medicated Gel Toothpaste|"A group of 19 patients will receive a toothpaste without the drug to act as a placebo.Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste that will be provided, 2 times a day for two minutes each time, for 30 days.~Non medicated gel toothpaste: Normal gel toothpaste used as placebo, brushing 1 minute 2 time a day, for 30 days."
111366|NCT01929135|O1|Outcome|Atorvastatin Toothpaste|"A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.~Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days."
111367|NCT01929135|E2|Reported Event|Placebo Group|"A group of 19 patients received Non-surgical periodontal treatment (NSPT) plus placebo dentifrice.Therapy was supplemented with oral hygiene instruction, indicating patients to brush with dentifrice 2 times a day for two minutes each time, for 30 days.~Non medicated dentifrice: fluoride dentifrice."
111368|NCT01929135|E1|Reported Event|Atorvastatin Group|"A group of 19 patients received Non-surgical periodontal treatment (NSPT) plus medicated 2% atorvastatin dentifrice. Therapy was supplemented with oral hygiene instruction, indicating patients to brush with the dentifrice 2 times a day for two minutes each time for a period of 30 days.~Atorvastatin dentifrice: fluoride dentifrice with 2% Atorvastatin (20 mg per ml)."
111369|NCT01929083|B1|Baseline|Entire Study Population|n=15 subjects who completed the study
111370|NCT01929083|P2|Participant Flow|Placebo First, Then Progesterone|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
111371|NCT01929083|P1|Participant Flow|Progesterone First, Then Placebo|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
111372|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
111373|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
111374|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
111375|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
111376|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
111377|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
111378|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
111379|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
111380|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
111381|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
111382|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
111383|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
111384|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
111385|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
111386|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
111387|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
111388|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
111389|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
111390|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
111392|NCT01929083|E2|Reported Event|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
111393|NCT01929083|E1|Reported Event|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
111394|NCT01929044|B3|Baseline|Total|Total of all reporting groups
111395|NCT01929044|B2|Baseline|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
111396|NCT01929044|B1|Baseline|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
111397|NCT01929044|P2|Participant Flow|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
111398|NCT01929044|P1|Participant Flow|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
111399|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
111400|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
111401|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
111402|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
111403|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
111404|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
111405|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
111406|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
111407|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
111408|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
111409|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
111410|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
111411|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
111412|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
111413|NCT01929044|E2|Reported Event|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
111414|NCT01929044|E1|Reported Event|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
111415|NCT01929031|B5|Baseline|Total|Total of all reporting groups
111416|NCT01929031|B4|Baseline|Ibuprofen/Caffeine Stage 1|One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery
111417|NCT01929031|B3|Baseline|Ibuprofen Stage 1|One Ibuprofen 400mg tablet after dental surgery
111418|NCT01929031|B2|Baseline|Caffeine Stage 1|One Caffeine 100mg tablet after dental surgery
111419|NCT01929031|B1|Baseline|Placebo Stage 1|One Placebo tablet after dental surgery
111420|NCT01929031|P6|Participant Flow|Placebo - Ibuprofen|Study stage 1: One Placebo tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400mg tablet, while awake, over 5 days
111421|NCT01929031|P5|Participant Flow|Placebo - Ibuprofen/Caffeine|Study stage 1: One Placebo tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400mg/Caffeine 100mg tablet, while awake, over 5 days
111422|NCT01929031|P4|Participant Flow|Caffeine - Ibuprofen|Study stage 1: One Caffeine 100mg tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400mg tablet, while awake, over 5 days
111423|NCT01929031|P3|Participant Flow|Caffeine - Ibuprofen/Caffeine|Study stage 1: One Caffeine 100mg tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400mg/Caffeine 100mg tablet, while awake, over 5 days
111424|NCT01929031|P2|Participant Flow|Ibuprofen - Ibuprofen|Study stage 1: One Ibuprofen 400mg tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400mg tablet, while awake, over 5 days
111425|NCT01929031|P1|Participant Flow|Ibuprofen/Caffeine - Ibuprofen/Caffeine|Study stage 1: One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen400mg/Caffeine 100mg tablet, while awake, over 5 days
111447|NCT01928940|B2|Baseline|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111448|NCT01928940|B1|Baseline|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111449|NCT01928940|P2|Participant Flow|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111450|NCT01928940|P1|Participant Flow|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111451|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111452|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111453|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111454|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111455|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111456|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111515|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111516|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111517|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111457|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111458|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111459|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111460|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111461|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111462|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111463|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111464|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111465|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111466|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111467|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111468|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111469|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111470|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111471|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111472|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111473|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111474|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111475|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111476|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111518|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111519|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111520|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
112724|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
111477|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111478|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111479|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111480|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111481|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111482|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111483|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111484|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111485|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111486|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111487|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111488|NCT01928940|E2|Reported Event|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111489|NCT01928940|E1|Reported Event|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
111490|NCT01928927|B3|Baseline|Total|Total of all reporting groups
111491|NCT01928927|B2|Baseline|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111492|NCT01928927|B1|Baseline|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111493|NCT01928927|P2|Participant Flow|Arm B: No Study Drug|"Participants will receive no study drug and will follow week 0-48 evaluation schedule.~Control"
111494|NCT01928927|P1|Participant Flow|Arm A: Telmisartan|"Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111495|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants will receive no study drug and will follow week 0-48 evaluation schedule.~Control"
111496|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111497|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants will receive no study drug and will follow week 0-48 evaluation schedule.~Control"
111498|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111499|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants will receive no study drug and will follow week 0-48 evaluation schedule.~Control"
111500|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111501|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants will receive no study drug and will follow week 0-48 evaluation schedule.~Control"
111502|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111503|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111504|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111505|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111506|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111507|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111508|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111509|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111510|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111511|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111512|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111513|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111514|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111521|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111522|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111523|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111524|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111525|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111526|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111527|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111528|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111529|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111530|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111531|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111532|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111533|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111534|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111535|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111536|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111537|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111538|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111539|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111540|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111541|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111542|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111543|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111544|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111545|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111546|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111547|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111548|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111549|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111550|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111551|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111552|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111553|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111554|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111555|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111556|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111557|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111558|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111559|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111560|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111561|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111562|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
127146|NCT01852162|O2|Outcome|Placebo|Placebo tablets
111563|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111564|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111565|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111566|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111567|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111568|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111569|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111570|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111571|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111572|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111573|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111574|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111575|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111576|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111577|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111578|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111579|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111580|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111581|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111582|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111583|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111584|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111585|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111586|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111587|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111588|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111589|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111590|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111591|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111592|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111593|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111594|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111595|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111596|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111597|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111598|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111599|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111600|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111601|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111602|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111603|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111604|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
127147|NCT01852162|O1|Outcome|Dabigatran|Dabigatran 150mg
111605|NCT01928927|O2|Outcome|Arm B: No Study Drug|Participants received no study drug and followed the week 0-48 evaluation schedule.
111606|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111607|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111608|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111609|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
111610|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111611|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and will follow week 0-48 evaluation schedule.~Control"
111612|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111613|NCT01928927|E2|Reported Event|Arm B: No Study Drug|"Participants received no study drug and will follow week 0-48 evaluation schedule.~Control"
111614|NCT01928927|E1|Reported Event|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
111615|NCT01928862|B6|Baseline|Total|Total of all reporting groups
111616|NCT01928862|B5|Baseline|Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years)|Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (13-16 years old).
111617|NCT01928862|B4|Baseline|Prepopik® 1 Sachet x 2 (13-16 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in “Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was 1 sachet for this subset of participants (13-16 years old)."
111618|NCT01928862|B3|Baseline|Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)|Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (9-12 years old).
111619|NCT01928862|B2|Baseline|Prepopik® 1 Sachet x 2 (9-12 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in “Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was 1 sachet for this subset of participants (9-12 years old)."
111620|NCT01928862|B1|Baseline|Prepopik® ½ Sachet x 2 (9-12 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in “Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was ½ sachet for this subset of participants (9-12 years old)."
111621|NCT01928862|P5|Participant Flow|Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years)|Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (13-16 years old).
111622|NCT01928862|P4|Participant Flow|Prepopik® 1 Sachet x 2 (13-16 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in “Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In “Day Before” method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was 1 sachet for this subset of participants (13-16 years old)."
111623|NCT01928862|P3|Participant Flow|Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)|Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (9-12 years old).
111624|NCT01928862|P2|Participant Flow|Prepopik® 1 Sachet x 2 (9-12 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in “Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was 1 sachet for this subset of participants (9-12 years old)."
111713|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111714|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
111715|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111625|NCT01928862|P1|Participant Flow|Prepopik® ½ Sachet x 2 (9-12 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in “Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was ½ sachet for this subset of participants (9-12 years old)."
111626|NCT01928862|O5|Outcome|Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years)|Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (13-16 years old).
111627|NCT01928862|O4|Outcome|Prepopik® 1 Sachet x 2 (13-16 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in “Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was 1 sachet for this subset of participants (13-16 years old)."
111628|NCT01928862|O3|Outcome|Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)|Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (9-12 years old).
111629|NCT01928862|O2|Outcome|Prepopik® 1 Sachet x 2 (9-12 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in “Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was 1 sachet for this subset of participants (9-12 years old)."
111630|NCT01928862|O1|Outcome|Prepopik® ½ Sachet x 2 (9-12 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in “Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was ½ sachet for this subset of participants (9-12 years old)."
111631|NCT01928862|O5|Outcome|Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years)|Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (13-16 years old).
111632|NCT01928862|O4|Outcome|Prepopik® 1 Sachet x 2 (13-16 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in “Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was 1 sachet for this subset of participants (13-16 years old)."
111633|NCT01928862|O3|Outcome|Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)|Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (9-12 years old).
111634|NCT01928862|O2|Outcome|Prepopik® 1 Sachet x 2 (9-12 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was 1 sachet for this subset of participants (9-12 years old)."
111635|NCT01928862|O1|Outcome|Prepopik® ½ Sachet x 2 (9-12 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in “Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was ½ sachet for this subset of participants (9-12 years old)."
111636|NCT01928862|O5|Outcome|Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years)|Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (13-16 years old).
111716|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111717|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
127148|NCT01852162|E2|Reported Event|Placebo|Placebo tablets
111637|NCT01928862|O4|Outcome|Prepopik® 1 Sachet x 2 (13-16 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in “Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was 1 sachet for this subset of participants (13-16 years old)."
111638|NCT01928862|O3|Outcome|Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)|Oral PEG preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (9-12 years old).
111639|NCT01928862|O2|Outcome|Prepopik® 1 Sachet x 2 (9-12 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in “Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was 1 sachet for this subset of participants (9-12 years old)."
111640|NCT01928862|O1|Outcome|Prepopik® ½ Sachet x 2 (9-12 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in “Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was ½ sachet for this subset of participants (9-12 years old)."
111641|NCT01928862|O5|Outcome|Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years)|Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (13-16 years old).
111642|NCT01928862|O4|Outcome|Prepopik® 1 Sachet x 2 (13-16 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in “Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was 1 sachet for this subset of participants (13-16 years old)."
111643|NCT01928862|O3|Outcome|Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)|Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (9-12 years old).
111644|NCT01928862|O2|Outcome|Prepopik® 1 Sachet x 2 (9-12 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in “Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was 1 sachet for this subset of participants (9-12 years old)."
111645|NCT01928862|O1|Outcome|Prepopik® ½ Sachet x 2 (9-12 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in “Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was ½ sachet for this subset of participants (9-12 years old)."
111646|NCT01928862|O5|Outcome|Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years)|Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (13-16 years old).
111647|NCT01928862|O4|Outcome|Prepopik® 1 Sachet x 2 (13-16 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in “Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was 1 sachet for this subset of participants (13-16 years old)."
111648|NCT01928862|O3|Outcome|Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)|Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (9-12 years old).
111718|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111719|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111649|NCT01928862|O2|Outcome|Prepopik® 1 Sachet x 2 (9-12 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in “Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was 1 sachet for this subset of participants (9-12 years old)."
111650|NCT01928862|O1|Outcome|Prepopik® ½ Sachet x 2 (9-12 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in “Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was ½ sachet for this subset of participants (9-12 years old)."
111651|NCT01928862|O5|Outcome|Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years)|Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (13-16 years old).
111652|NCT01928862|O4|Outcome|Prepopik® 1 Sachet x 2 (13-16 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in “Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was 1 sachet for this subset of participants (13-16 years old)."
111653|NCT01928862|O3|Outcome|Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)|Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (9-12 years old).
111654|NCT01928862|O2|Outcome|Prepopik® 1 Sachet x 2 (9-12 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in “Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was 1 sachet for this subset of participants (9-12 years old)."
111655|NCT01928862|O1|Outcome|Prepopik® ½ Sachet x 2 (9-12 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in “Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was ½ sachet for this subset of participants (9-12 years old)."
111656|NCT01928862|E5|Reported Event|Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years)|Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (13-16 years old).
111657|NCT01928862|E4|Reported Event|Prepopik® 1 Sachet x 2 (13-16 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in “Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was 1 sachet for this subset of participants (13-16 years old)."
111658|NCT01928862|E3|Reported Event|Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)|Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (9-12 years old).
111659|NCT01928862|E2|Reported Event|Prepopik® 1 Sachet x 2 (9-12 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in “Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was 1 sachet for this subset of participants (9-12 years old)."
111720|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
111721|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111722|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111723|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
111724|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111660|NCT01928862|E1|Reported Event|Prepopik® ½ Sachet x 2 (9-12 Years)|"Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in “Split Dose” method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.~“Day Before” method was the alternative method if “Split Dose” was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.~The dose was ½ sachet for this subset of participants (9-12 years old)."
111661|NCT01928797|B3|Baseline|Total|Total of all reporting groups
111662|NCT01928797|B2|Baseline|Study Group|cardiac output monitor will be attached CO values will guide vasopressor use in addition blood pressure and heart rate
111663|NCT01928797|B1|Baseline|Control Group|cardiac output monitor will be attached CO values will not be used to guide vasopressor use. The care provider will use blood pressure and heart rate data to guide vasopressor use.
111664|NCT01928797|P2|Participant Flow|Study Group|Vasopressor use based on the cardiac output, blood pressure and heart rate.
111665|NCT01928797|P1|Participant Flow|Control Group|Vasopressor use based on blood pressure and heart rate. Cardiac output data was blinded to the care providers.
111666|NCT01928797|O2|Outcome|Study Group|Vasopressor use based on the cardiac output, blood pressure and heart rate
111667|NCT01928797|O1|Outcome|Control Group|Vasopressor use based on the blood pressure changes and heart rate
111668|NCT01928797|O2|Outcome|Study Group|Vasopressor use based on the cardiac output, blood pressure and heart rate
111669|NCT01928797|O1|Outcome|Control Group|Vasopressor use based on the blood pressure changes and heart rate
111670|NCT01928797|O2|Outcome|Study Group|cardiac output monitor will be attached and CO data used to guide management based on the protocol
111671|NCT01928797|O1|Outcome|Control Group|cardiac output monitor will be attached but CO values will not guide vasopressor use as CO data is blinded to care provider
111672|NCT01928797|E2|Reported Event|Study Group|cardiac output monitor will be attached CO values will guide vasopressor protocol use
111673|NCT01928797|E1|Reported Event|Control Group|cardiac output monitor will be attached but will not guide treatment based on cardiac output. The treatment will be based on blood pressure changes.
111674|NCT01928771|B4|Baseline|Total|Total of all reporting groups
111675|NCT01928771|B3|Baseline|Placebo|Placebo administered subcutaneously
111676|NCT01928771|B2|Baseline|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111677|NCT01928771|B1|Baseline|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111678|NCT01928771|P3|Participant Flow|Placebo|Placebo administered subcutaneously
111679|NCT01928771|P2|Participant Flow|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111680|NCT01928771|P1|Participant Flow|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111681|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
111682|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111683|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111684|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
111685|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111686|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111687|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
111688|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111689|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111690|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
111691|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111692|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111693|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
111694|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111695|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111696|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
111697|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111698|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111699|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
111700|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111701|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111702|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
111703|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111704|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111705|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
111706|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111707|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111708|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
111709|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111710|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111711|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
111712|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111725|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111726|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
111727|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111728|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111729|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
111730|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111731|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111732|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
111733|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111734|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111735|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
111736|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111737|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111738|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
111739|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111740|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111741|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
111742|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111743|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111744|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
111745|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111746|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111747|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
111748|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111749|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111750|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
111751|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111752|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111753|NCT01928771|E3|Reported Event|Placebo|Placebo administered subcutaneously
111754|NCT01928771|E2|Reported Event|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
111755|NCT01928771|E1|Reported Event|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
111756|NCT01928693|B4|Baseline|Total|Total of all reporting groups
111757|NCT01928693|B3|Baseline|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111758|NCT01928693|B2|Baseline|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111759|NCT01928693|B1|Baseline|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111760|NCT01928693|P3|Participant Flow|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111761|NCT01928693|P2|Participant Flow|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111762|NCT01928693|P1|Participant Flow|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111825|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111763|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111764|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111765|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111766|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111767|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111768|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111769|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111770|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111771|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111772|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111773|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111774|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111788|NCT01928680|P1|Participant Flow|Cisplatin/Capecitabine|"Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity.~This is a single arm phase II clinical trial.~Cisplatin/Capecitabine: Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity"
127149|NCT01852162|E1|Reported Event|Dabigatran|Dabigatran 150mg tablets
111775|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111776|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111777|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111778|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111779|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111780|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111781|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111782|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111783|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111784|NCT01928693|E3|Reported Event|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111785|NCT01928693|E2|Reported Event|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111786|NCT01928693|E1|Reported Event|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
111787|NCT01928680|B1|Baseline|Cisplatin/Capecitabine|"Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity.~This is a single arm phase II clinical trial.~Cisplatin/Capecitabine: Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity"
127150|NCT01852110|B3|Baseline|Total|Total of all reporting groups
111789|NCT01928680|O1|Outcome|Cisplatin/Capecitabine|"Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity.~This is a single arm phase II clinical trial.~Cisplatin/Capecitabine: Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity"
111790|NCT01928680|E1|Reported Event|Cisplatin/Capecitabine|"Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity.~This is a single arm phase II clinical trial.~Cisplatin/Capecitabine: Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity"
111791|NCT01928615|B1|Baseline|Trastuzumab|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants were randomized to receive trastuzumab 600 mg subcutaneously every 3 weeks in the thigh and upper arm in a cross-over design for a total of 24 weeks (Cycles 7-14). They received trastuzumab either in the thigh first for 4 cycles (Cycles 7-10) followed by trastuzumab in the upper arm for 4 cycles (Cycles 11-14) or the upper arm first (Cycles 7-10) followed by the thigh (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
111792|NCT01928615|P1|Participant Flow|Trastuzumab|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants were randomized to receive trastuzumab 600 mg subcutaneously every 3 weeks in the thigh and upper arm in a cross-over design for a total of 24 weeks (Cycles 7-14). They received trastuzumab either in the thigh first for 4 cycles (Cycles 7-10) followed by trastuzumab in the upper arm for 4 cycles (Cycles 11-14) or the upper arm first (Cycles 7-10) followed by the thigh (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
111793|NCT01928615|O2|Outcome|Trastuzumab - Upper Arm First, Then Thigh|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the upper arm for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the thigh for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
111794|NCT01928615|O1|Outcome|Trastuzumab - Thigh First, Then Upper Arm|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the thigh for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the upper arm for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
111795|NCT01928615|O2|Outcome|Trastuzumab - Upper Arm First, Then Thigh|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the upper arm for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the thigh for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
111796|NCT01928615|O1|Outcome|Trastuzumab - Thigh First, Then Upper Arm|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the thigh for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the upper arm for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
111797|NCT01928615|O2|Outcome|Trastuzumab - Upper Arm First, Then Thigh|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the upper arm for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the thigh for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
111798|NCT01928615|O1|Outcome|Trastuzumab - Thigh First, Then Upper Arm|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the thigh for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the upper arm for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
111799|NCT01928615|O2|Outcome|Trastuzumab - Upper Arm First, Then Thigh|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the upper arm for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the thigh for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
111973|NCT01927757|O2|Outcome|Absence of Anti-adalimumab Antibodies|Participants with absence of anti-adalimumab antibodies.
111800|NCT01928615|O1|Outcome|Trastuzumab - Thigh First, Then Upper Arm|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the thigh for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the upper arm for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
111801|NCT01928615|O2|Outcome|Trastuzumab - Upper Arm First, Then Thigh|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the upper arm for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the thigh for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
111802|NCT01928615|O1|Outcome|Trastuzumab - Thigh First, Then Upper Arm|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the thigh for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the upper arm for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
111803|NCT01928615|O2|Outcome|Trastuzumab - Upper Arm First, Then Thigh|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the upper arm for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the thigh for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
111804|NCT01928615|O1|Outcome|Trastuzumab - Thigh First, Then Upper Arm|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the thigh for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the upper arm for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
111805|NCT01928615|E1|Reported Event|Trastuzumab|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants were randomized to receive trastuzumab 600 mg subcutaneously every 3 weeks in the thigh and upper arm in a cross-over design for a total of 24 weeks (Cycles 7-14). They received trastuzumab either in the thigh first for 4 cycles (Cycles 7-10) followed by trastuzumab in the upper arm for 4 cycles (Cycles 11-14) or the upper arm first (Cycles 7-10) followed by the thigh (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
111806|NCT01928472|B5|Baseline|TOTAL|Total of all reporting groups
111807|NCT01928472|B4|Baseline|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
111808|NCT01928472|B3|Baseline|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111809|NCT01928472|B2|Baseline|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111810|NCT01928472|B1|Baseline|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
111811|NCT01928472|P4|Participant Flow|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
111812|NCT01928472|P3|Participant Flow|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111813|NCT01928472|P2|Participant Flow|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111814|NCT01928472|P1|Participant Flow|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
111815|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
111816|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111817|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111818|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
111819|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
111820|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111821|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111822|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
111823|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
111824|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
112725|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
111826|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
111827|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
111828|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111829|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111830|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
111831|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
111832|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111833|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111834|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
111835|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
111836|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111837|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111838|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
111839|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
111840|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111841|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111842|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
111843|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
111844|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111845|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111846|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
111847|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
111848|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111849|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111850|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
111851|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
111852|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111853|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111854|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
111855|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
111856|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111857|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111858|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
111859|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
111860|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111861|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111862|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
111863|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
111864|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111865|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111866|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
111867|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
111868|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111869|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111870|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
111871|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
111872|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111873|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111874|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
111875|NCT01928472|E5|Reported Event|TOTAL|Total of all reporting groups.
111876|NCT01928472|E4|Reported Event|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
111877|NCT01928472|E3|Reported Event|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111878|NCT01928472|E2|Reported Event|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111879|NCT01928472|E1|Reported Event|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
111880|NCT01928433|B4|Baseline|Total|Total of all reporting groups
111881|NCT01928433|B3|Baseline|Ciprofloxacin 10 Days|"Ciprofloxacin (i.v. and oral) for a total of 10 days.~Finafloxacin placebo i.v. once daily~Finafloxacin placebo tablets (as four tablets) once daily~Ciprofloxacin 400 mg i.v. two times daily~Ciprofloxacin 500 mg oral (as two 250 mg capsules) two times daily"
111882|NCT01928433|B2|Baseline|Finafloxacin 10 Days|"Finafloxacin (i.v. and oral) for a total of 10 days.~Finafloxacin 800 mg i.v. once daily~Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily~Ciprofloxacin placebo i.v. two times daily~Ciprofloxacin placebo oral (as two capsules each) two times daily"
111883|NCT01928433|B1|Baseline|Finafloxacin 5 Days|"Finafloxacin (i.v. and oral) for a total of 5 days.~Finafloxacin 800 mg i.v. once daily~Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily~Ciprofloxacin placebo i.v. two times daily~Ciprofloxacin placebo oral (as two capsules each) two times daily"
111884|NCT01928433|P3|Participant Flow|Ciprofloxacin 10 Days|"Ciprofloxacin (i.v. and oral) for a total of 10 days.~Finafloxacin placebo i.v. once daily~Finafloxacin placebo tablets (as four tablets) once daily~Ciprofloxacin 400 mg i.v. two times daily~Ciprofloxacin 500 mg oral (as two 250 mg capsules) two times daily"
111885|NCT01928433|P2|Participant Flow|Finafloxacin 10 Days|"Finafloxacin (i.v. and oral) for a total of 10 days.~Finafloxacin 800 mg i.v. once daily~Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily~Ciprofloxacin placebo i.v. two times daily~Ciprofloxacin placebo oral (as two capsules each) two times daily"
111886|NCT01928433|P1|Participant Flow|Finafloxacin 5 Days|"Finafloxacin (i.v. and oral) for a total of 5 days.~Finafloxacin 800 mg i.v. once daily~Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily~Ciprofloxacin placebo i.v. two times daily~Ciprofloxacin placebo oral (as two capsules each) two times daily"
111887|NCT01928433|O3|Outcome|Ciprofloxacin 10 Days|"Ciprofloxacin (i.v. and oral) for a total of 10 days.~Finafloxacin placebo i.v. once daily~Finafloxacin placebo tablets (as four tablets) once daily~Ciprofloxacin 400 mg i.v. two times daily~Ciprofloxacin 500 mg oral (as two 250 mg capsules) two times daily"
111888|NCT01928433|O2|Outcome|Finafloxacin 10 Days|"Finafloxacin (i.v. and oral) for a total of 10 days.~Finafloxacin 800 mg i.v. once daily~Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily~Ciprofloxacin placebo i.v. two times daily~Ciprofloxacin placebo oral (as two capsules each) two times daily"
111889|NCT01928433|O1|Outcome|Finafloxacin 5 Days|"Finafloxacin (i.v. and oral) for a total of 5 days.~Finafloxacin 800 mg i.v. once daily~Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily~Ciprofloxacin placebo i.v. two times daily~Ciprofloxacin placebo oral (as two capsules each) two times daily"
111890|NCT01928433|O3|Outcome|Ciprofloxacin 10 Days|"Ciprofloxacin (i.v. and oral) for a total of 10 days.~Finafloxacin placebo i.v. once daily~Finafloxacin placebo tablets (as four tablets) once daily~Ciprofloxacin 400 mg i.v. two times daily~Ciprofloxacin 500 mg oral (as two 250 mg capsules) two times daily"
111891|NCT01928433|O2|Outcome|Finafloxacin 10 Days|"Finafloxacin (i.v. and oral) for a total of 10 days.~Finafloxacin 800 mg i.v. once daily~Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily~Ciprofloxacin placebo i.v. two times daily~Ciprofloxacin placebo oral (as two capsules each) two times daily"
111892|NCT01928433|O1|Outcome|Finafloxacin 5 Days|"Finafloxacin (i.v. and oral) for a total of 5 days.~Finafloxacin 800 mg i.v. once daily~Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily~Ciprofloxacin placebo i.v. two times daily~Ciprofloxacin placebo oral (as two capsules each) two times daily"
111893|NCT01928433|O3|Outcome|Ciprofloxacin 10 Days|"Ciprofloxacin (i.v. and oral) for a total of 10 days.~Finafloxacin placebo i.v. once daily~Finafloxacin placebo tablets (as four tablets) once daily~Ciprofloxacin 400 mg i.v. two times daily~Ciprofloxacin 500 mg oral (as two 250 mg capsules) two times daily"
111894|NCT01928433|O2|Outcome|Finafloxacin 10 Days|"Finafloxacin (i.v. and oral) for a total of 10 days.~Finafloxacin 800 mg i.v. once daily~Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily~Ciprofloxacin placebo i.v. two times daily~Ciprofloxacin placebo oral (as two capsules each) two times daily"
111895|NCT01928433|O1|Outcome|Finafloxacin 5 Days|"Finafloxacin (i.v. and oral) for a total of 5 days.~Finafloxacin 800 mg i.v. once daily~Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily~Ciprofloxacin placebo i.v. two times daily~Ciprofloxacin placebo oral (as two capsules each) two times daily"
111896|NCT01928433|O3|Outcome|Ciprofloxacin 10 Days|"Ciprofloxacin (i.v. and oral) for a total of 10 days.~Finafloxacin placebo i.v. once daily~Finafloxacin placebo tablets (as four tablets) once daily~Ciprofloxacin 400 mg i.v. two times daily~Ciprofloxacin 500 mg oral (as two 250 mg capsules) two times daily"
111897|NCT01928433|O2|Outcome|Finafloxacin 10 Days|"Finafloxacin (i.v. and oral) for a total of 10 days.~Finafloxacin 800 mg i.v. once daily~Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily~Ciprofloxacin placebo i.v. two times daily~Ciprofloxacin placebo oral (as two capsules each) two times daily"
111898|NCT01928433|O1|Outcome|Finafloxacin 5 Days|"Finafloxacin (i.v. and oral) for a total of 5 days.~Finafloxacin 800 mg i.v. once daily~Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily~Ciprofloxacin placebo i.v. two times daily~Ciprofloxacin placebo oral (as two capsules each) two times daily"
111948|NCT01928030|P1|Participant Flow|450 Units rHuPH20 (Days 1, 3, 5, and 7)|Patients receive 450 units rHuPH20 SC on days 1, 3, 5, and 7
111899|NCT01928433|O3|Outcome|Ciprofloxacin 10 Days|"Intervention:~Ciprofloxacin 400 mg i.v. twice daily and Finafloxacin placebo i.v. once daily Ciprofloxacin 500 mg oral twice daily and Finafloxacin placebo tablets once daily Ciprofloxacin (i.v. and oral) for a total of 10 days.~Finafloxacin placebo i.v. once daily: Infused over 60 mins [i.v. pump]) for at least 3 days.~Finafloxacin placebo tablets once daily: Administered as four tablets~Ciprofloxacin 400 mg i.v. twice daily: Infused over approximately 60 mins [i.v. pump]) for at least 3 days~Ciprofloxacin 500 mg oral twice daily: Administered as two 250 mg capsules."
111900|NCT01928433|O2|Outcome|Finafloxacin 10 Days|"Intervention:~Finafloxacin 800 mg i.v. once daily and Ciprofloxacin placebo i.v. twice daily. Finafloxacin 800 mg tablets once daily and Ciprofloxacin placebo oral twice daily Finafloxacin verum (i.v. and oral) for a total of 10 days.~Finafloxacin 800 mg i.v. once daily: Infused over 60 mins [i.v. pump]) for at least 3 days.~Finafloxacin 800 mg tablets once daily: Administered as four 200 mg tablets~Ciprofloxacin placebo i.v. twice daily: Infused over approximately 60 mins [i.v. pump]) for at least 3 days~Ciprofloxacin placebo oral twice daily: Administered as two capsules."
111901|NCT01928433|O1|Outcome|Finafloxacin 5 Days|"Intervention:~Finafloxacin 800 mg i.v. once daily and Ciprofloxacin placebo i.v. twice daily. Finafloxacin 800 mg tablets once daily and Ciprofloxacin placebo oral twice daily Finafloxacin verum (i.v. and oral) for a total of 5 days.~Finafloxacin 800 mg i.v. once daily: Infused over 60 mins [i.v. pump]) for at least 3 days.~Finafloxacin 800 mg tablets once daily: Administered as four 200 mg tablets~Ciprofloxacin placebo i.v. twice daily: Infused over approximately 60 mins [i.v. pump]) for at least 3 days~Ciprofloxacin placebo oral twice daily: Administered as two capsules."
111902|NCT01928433|O3|Outcome|Ciprofloxacin 10 Days|"Ciprofloxacin (i.v. and oral) for a total of 10 days.~Finafloxacin placebo i.v. once daily~Finafloxacin placebo tablets (as four tablets) once daily~Ciprofloxacin 400 mg i.v. two times daily~Ciprofloxacin 500 mg oral (as two 250 mg capsules) two times daily"
111903|NCT01928433|O2|Outcome|Finafloxacin 10 Days|"Finafloxacin (i.v. and oral) for a total of 10 days.~Finafloxacin 800 mg i.v. once daily~Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily~Ciprofloxacin placebo i.v. two times daily~Ciprofloxacin placebo oral (as two capsules each) two times daily"
111904|NCT01928433|O1|Outcome|Finafloxacin 5 Days|"Finafloxacin (i.v. and oral) for a total of 5 days.~Finafloxacin 800 mg i.v. once daily~Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily~Ciprofloxacin placebo i.v. two times daily~Ciprofloxacin placebo oral (as two capsules each) two times daily"
111905|NCT01928433|E3|Reported Event|Ciprofloxacin 10 Days|"Ciprofloxacin (i.v. and oral) for a total of 10 days.~Finafloxacin placebo i.v. once daily~Finafloxacin placebo tablets (as four tablets) once daily~Ciprofloxacin 400 mg i.v. two times daily~Ciprofloxacin 500 mg oral (as two 250 mg capsules) two times daily"
111906|NCT01928433|E2|Reported Event|Finafloxacin 10 Days|"Finafloxacin (i.v. and oral) for a total of 10 days.~Finafloxacin 800 mg i.v. once daily~Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily~Ciprofloxacin placebo i.v. two times daily~Ciprofloxacin placebo oral (as two capsules each) two times daily"
111907|NCT01928433|E1|Reported Event|Finafloxacin 5 Days|"Finafloxacin (i.v. and oral) for a total of 5 days.~Finafloxacin 800 mg i.v. once daily~Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily~Ciprofloxacin placebo i.v. two times daily~Ciprofloxacin placebo oral (as two capsules each) two times daily"
111908|NCT01928381|B1|Baseline|Overall Study|Overall Study - Starting with Part 1
111909|NCT01928381|P7|Participant Flow|Sequence 6|Sequence 6 - 1st AZD5213 + pregabalin, 2nd pregabalin, 3rd placebo
111910|NCT01928381|P6|Participant Flow|Sequence 5|Sequence 5 - 1st AZD5213 + pregabalin, 2nd placebo, 3rd pregabalin
111911|NCT01928381|P5|Participant Flow|Sequence 4|Sequence 4 - 1st pregabalin, 2nd AZD5213 + pregabalin, 3rd placebo
111912|NCT01928381|P4|Participant Flow|Sequence 3|Sequence 3 - 1st pregabalin, 2nd placebo, 3rd AZD5213 + pregabalin
111913|NCT01928381|P3|Participant Flow|Sequence 2|Sequence 2 - 1st Placebo, 2nd AZD5213 + pregabalin, 3rd pregabalin
111914|NCT01928381|P2|Participant Flow|Sequence 1|Sequence 1 - 1st placebo, 2nd pregabalin, 3rd AZD5213 + pregabalin
111915|NCT01928381|P1|Participant Flow|Part 1 - Pain Training|Part 1 - Screening, Pain Training, placebo run-in eligibility for Part 2
111916|NCT01928381|O3|Outcome|Part 2 - Pregabalin|Part 2 pregabalin crossover periods
111917|NCT01928381|O2|Outcome|Part 2 - Pregabalin + AZD5213|Part 2 - Combined pregabalin + AZD5213 crossover periods
111918|NCT01928381|O1|Outcome|Part 2 - Placebo|Part 2 - placebo crossover periods
111919|NCT01928381|O3|Outcome|Part 2 - Pregabalin|Part 2 pregabalin crossover periods
111920|NCT01928381|O2|Outcome|Part 2 - Pregabalin + AZD5213|Part 2 - Combined pregabalin + AZD5213 crossover periods
111921|NCT01928381|O1|Outcome|Part 2 - Placebo|Part 2 - placebo crossover periods
111922|NCT01928381|E5|Reported Event|Overall Study|Overall Study: Part 1 and Part 2
111923|NCT01928381|E4|Reported Event|Part 2 - Pregabalin|Part 2 pregabalin crossover periods
111924|NCT01928381|E3|Reported Event|Part 2 - Pregabalin + AZD5213|Part 2 - Combined pregabalin + AZD5213 crossover periods
111925|NCT01928381|E2|Reported Event|Part 2 - Placebo|Part 2 - placebo crossover periods
111926|NCT01928381|E1|Reported Event|Part 1|Part 1 - Pain training + 1 week of single blind placebo
111927|NCT01928186|B1|Baseline|Diagnostic (FLT PET)|"Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.~Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine.~Positron Emission Tomography: Undergo FLT PET~Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen."
111928|NCT01928186|P1|Participant Flow|Diagnostic (FLT PET)|"Patients undergo FLT PET at baseline and 1-6 weeks after the start of treatment.~Fluorothymidine F-18: Undergo FLT PET~Positron Emission Tomography: Undergo FLT PET~Laboratory Biomarker Analysis: Correlative studies"
111929|NCT01928186|O1|Outcome|Diagnostic (FLT PET)|"Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.~Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine.~Positron Emission Tomography: Undergo FLT PET~Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen."
130311|NCT01836458|O3|Outcome|Dose 3: 10 mg|Single dose of KAE609 10 mg
111930|NCT01928186|O1|Outcome|Diagnostic (FLT PET)|"Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.~Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine.~Positron Emission Tomography: Undergo FLT PET~Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen."
111931|NCT01928186|O1|Outcome|Diagnostic (FLT PET)|"Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.~Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine.~Positron Emission Tomography: Undergo FLT PET~Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen."
111932|NCT01928186|O1|Outcome|Diagnostic (FLT PET)|"Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.~Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine.~Positron Emission Tomography: Undergo FLT PET~Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen."
111933|NCT01928186|O1|Outcome|Diagnostic (FLT PET)|"Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.~Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine.~Positron Emission Tomography: Undergo FLT PET~Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen."
111934|NCT01928186|O1|Outcome|Diagnostic (FLT PET)|"Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.~Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine.~Positron Emission Tomography: Undergo FLT PET~Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen."
111935|NCT01928186|O1|Outcome|Diagnostic (FLT PET)|"Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.~Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine.~Positron Emission Tomography: Undergo FLT PET~Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen."
111936|NCT01928186|O1|Outcome|Diagnostic (FLT PET)|"Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.~Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine.~Positron Emission Tomography: Undergo FLT PET~Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen."
111937|NCT01928186|O1|Outcome|Diagnostic (FLT PET)|"Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.~Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine.~Positron Emission Tomography: Undergo FLT PET~Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen."
111938|NCT01928186|O1|Outcome|Diagnostic (FLT PET)|"Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.~Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine.~Positron Emission Tomography: Undergo FLT PET~Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen."
111939|NCT01928186|O1|Outcome|Diagnostic (FLT PET)|"Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.~Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine.~Positron Emission Tomography: Undergo FLT PET~Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen."
111940|NCT01928186|E1|Reported Event|Diagnostic (FLT PET)|"Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.~Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine.~Positron Emission Tomography: Undergo FLT PET~Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen."
111941|NCT01928082|B1|Baseline|Transdermal Estradiol|"Transdermal estradiol 0.05 mg/day for 4 weeks, followed by 0.10 mg/day for 4 weeks~Transdermal estradiol: 4 weeks of Vivelle-Dot 0.05 mg/day followed by 4 weeks of Vivelle-Dot 0.10 mg/day"
111942|NCT01928082|P1|Participant Flow|Transdermal Estradiol|"Transdermal estradiol 0.05 mg/day for 4 weeks, followed by 0.10 mg/day for 4 weeks~Transdermal estradiol: 4 weeks of Vivelle-Dot 0.05 mg/day followed by 4 weeks of Vivelle-Dot 0.10 mg/day"
111943|NCT01928082|O1|Outcome|Transdermal Estradiol|"Transdermal estradiol 0.05 mg/day for 4 weeks, followed by 0.10 mg/day for 4 weeks~Transdermal estradiol: 4 weeks of Vivelle-Dot 0.05 mg/day followed by 4 weeks of Vivelle-Dot 0.10 mg/day"
111944|NCT01928082|E1|Reported Event|Transdermal Estradiol|"Transdermal estradiol 0.05 mg/day for 4 weeks, followed by 0.10 mg/day for 4 weeks~Transdermal estradiol: 4 weeks of Vivelle-Dot 0.05 mg/day followed by 4 weeks of Vivelle-Dot 0.10 mg/day"
111945|NCT01928030|B1|Baseline|Hyaluronidase, Recombinant Human|Patients receive recombinant human hyaluronidase 450 units or 900 units SC on days 1, 3, 5, and 7 (Phase 1) and then on days 1 to 21 (Phase 2) in the absence of disease progression or unacceptable toxicity.
111946|NCT01928030|P3|Participant Flow|MTD rHuPH20 (Days 1 to 21)|Days 1 to 21 Patients receive the maximum tolerated dose (MTD) of rHuPH20 SC on days 1 to 21.
111947|NCT01928030|P2|Participant Flow|900 Units rHuPH20 (Days 1, 3, 5, and 7)|Patients receive 900 units rHuPH20 SC on days 1, 3, 5, and 7
111949|NCT01928030|O3|Outcome|MTD rHuPH20 (Days 1 to 21)|Days 1 to 21 Patients receive the maximum tolerated dose (MTD) of rHuPH20 SC on days 1 to 21.
111950|NCT01928030|O2|Outcome|900 Units rHuPH20 (Days 1, 3, 5, and 7)|Patients receive 900 units rHuPH20 SC on days 1, 3, 5, and 7
111951|NCT01928030|O1|Outcome|450 Units rHuPH20 (Days 1, 3, 5, and 7)|Patients receive 450 units rHuPH20 SC on days 1, 3, 5, and 7
111952|NCT01928030|O1|Outcome|450 Units Recombinant Human Hyaluronidase (rHuPH20)|Participants receive 450 units recombinant human hyaluronidase (rHuPH20) subcutaneously (SC) on Days 1, 3, 5, and 7 (Phase 1) and then on Days 1 to 21 (Phase 2) in the absence of disease progression or unacceptable toxicity.
111953|NCT01928030|E1|Reported Event|Recombinant Human Hyaluronidase|"Participants who received 450 units recombinant human hyaluronidase (rHuPH20) subcutaneously in Phase 1 were assessed in this outcome measure, treatment-related adverse events.~Biomarker analysis and pharmacology study were performed during study.~recombinant human hyaluronidase: Given subcutaneously"
111954|NCT01927887|B1|Baseline|Nanoparticle Enhanced MRI|"Each subject will have one MRI scan at MGH. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed.The MR imaging will include conventional T1 and T2 weighted spin echo and 3 D gradient echo sequences.~Ferumoxytol: Ferumoxytol will be administered as an undiluted intravenous injection dose of 6 mg/kg body weight, up to a maximum dose of 510 mg, delivered at a rate of up to 1ml/sec. Each ml of the supplied agent contains 30 mg of elemental iron and the dose will be titrated based on patients body weight in kilograms; for example at a dose of 6 mg/kg, the dose for a 50 kg person will be 50 x 6 = 300 mg. As the vial contains 30 mg/ml, 10 cc of the dose will correspond to the required 300 mg dose.~lymphotrophic superparamagnetic nanoparticle"
111955|NCT01927887|P1|Participant Flow|Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)|Each subject will have one MRI scan. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed. Subjects will be imaged at Massachusetts General Hospital using commercial 3.0T imaging systems using dedicated neck coil and approved imaging protocols.Ferumoxytol will be administered as an undiluted intravenous injection dose of 6 mg/kg body weight, up to a maximum dose of 510 mg, delivered at a rate of up to 1ml/sec.
111956|NCT01927887|O1|Outcome|Nanoparticle MRI|Nanoparticle MRI: Each subject will have one MRI scan. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed. Subjects will be imaged at Massachusetts General Hospital using commercial 3.0T imaging systems using dedicated neck coil and approved imaging protocols. The MR imaging will include conventional T1 and T2 weighted spin echo and 3 D gradient echo sequences.
111957|NCT01927887|O1|Outcome|Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)|"Each subject will have one MRI scan. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed. The MR imaging will include conventional T1 and T2 weighted spin echo and 3 D gradient echo sequences.~Ferumoxytol: Ferumoxytol will be administered as an undiluted intravenous injection dose of 6 mg/kg body weight, up to a maximum dose of 510 mg, delivered at a rate of up to 1ml/sec. Each ml of the supplied agent contains 30 mg of elemental iron and the dose will be titrated based on patients body weight in kilograms; for example at a dose of 6 mg/kg, the dose for a 50 kg person will be 50 x 6 = 300 mg. As the vial contains 30 mg/ml, 10 cc of the dose will correspond to the required 300 mg dose.~lymphotrophic superparamagnetic nanoparticle"
111958|NCT01927887|E1|Reported Event|Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)|"Each subject will have one MRI scan. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed. The MR imaging will include conventional T1 and T2 weighted spin echo and 3 D gradient echo sequences.~Ferumoxytol: Ferumoxytol will be administered as an undiluted intravenous injection dose of 6 mg/kg body weight, up to a maximum dose of 510 mg, delivered at a rate of up to 1ml/sec. Each ml of the supplied agent contains 30 mg of elemental iron and the dose will be titrated based on patients body weight in kilograms; for example at a dose of 6 mg/kg, the dose for a 50 kg person will be 50 x 6 = 300 mg. As the vial contains 30 mg/ml, 10 cc of the dose will correspond to the required 300 mg dose.~lymphotrophic superparamagnetic nanoparticle"
111959|NCT01927757|B1|Baseline|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
111960|NCT01927757|P1|Participant Flow|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
111961|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
111962|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
111963|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
111964|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
111965|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
111966|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
111967|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
111968|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
111969|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
111970|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
111971|NCT01927757|O2|Outcome|Secondary Failure|Participants who lost a satisfactory response (defined as achievement of ACR20 or equivalent as judged by the investigator) to a combination treatment of adalimumab and methotrexate. This combination treatment must have been taken for at least 6 months.
111972|NCT01927757|O1|Outcome|Primary Failure|Participants failed to respond (defined as achievement of ACR20 or equivalent as judged by the investigator) to a combination treatment of adalimumab and methotrexate. This combination treatment must have been taken for at least 3 months.
111974|NCT01927757|O1|Outcome|Presence of Anti-adalimumab Antibodies|Participants with anti-adalimumab antibodies.
111975|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
111976|NCT01927757|E1|Reported Event|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
111977|NCT01927575|B1|Baseline|All Study Participants|"Standard X-Ray + CT arm to be used as comparative arm for investigational imaging device. Investigators will determine standard of care to be used on a per subject basis.~Standard X-Ray + CT: Standard of Care X-Ray Imaging + CT~Followed by Tomo Imaging"
111978|NCT01927575|P1|Participant Flow|All Study Participants|"Standard of care X-Ray imaging plus CT to be compared with research imaging device.~Standard X-Ray: Standard of Care X-Ray Imaging + CT~Followed by Tomo Imaging"
111979|NCT01927575|O3|Outcome|Tomosynthesis|"Tomosynthesis imaging to be compared to standard of care CT and X-ray~No AEs"
111980|NCT01927575|O2|Outcome|Standard CT|"Standard of care CT imaging to be compared with research imaging device.~Followed by Tomo imaging~No AE's"
111981|NCT01927575|O1|Outcome|Standard X-Ray|"Standard of care X-Ray imaging to be compared with research imaging device.~Followed by Tomo imaging~No AE's"
111982|NCT01927575|E3|Reported Event|Tomo|"Standard of care X-Ray, and CT imaging to be compared with research imaging device.~Standard X-Ray: Standard of Care X-Ray Imaging~Followed by Tomo imaging~No AE's during X-ray, CT or Tomo."
111983|NCT01927575|E2|Reported Event|Standard CT|"Standard of care X-Ray, and CT imaging to be compared with research imaging device.~Standard X-Ray: Standard of Care X-Ray Imaging~Followed by Tomo imaging~No AE's during X-ray, CT or Tomo."
111984|NCT01927575|E1|Reported Event|Standard X-Ray|"Standard of care X-Ray, and CT imaging to be compared with research imaging device.~Standard X-Ray: Standard of Care X-Ray Imaging~Followed by Tomo imaging~No AE's during X-ray, CT or Tomo."
111985|NCT01927419|B3|Baseline|Total|Total of all reporting groups
111986|NCT01927419|B2|Baseline|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
111987|NCT01927419|B1|Baseline|Nivolumab + Ipilimumab|Participants received (Part) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
111988|NCT01927419|P2|Participant Flow|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
111989|NCT01927419|P1|Participant Flow|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
111990|NCT01927419|O2|Outcome|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
111991|NCT01927419|O1|Outcome|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
111992|NCT01927419|O2|Outcome|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
111993|NCT01927419|O1|Outcome|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) until documented disease progression, toxicity, withdrawal of consent, or study completion.
111994|NCT01927419|O2|Outcome|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
111995|NCT01927419|O1|Outcome|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
111996|NCT01927419|O2|Outcome|Placebo + Ipilimumab|Participants received placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
111997|NCT01927419|O1|Outcome|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
111998|NCT01927419|O2|Outcome|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
111999|NCT01927419|O1|Outcome|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
112036|NCT01926977|O2|Outcome|Aflibercept 2.0mg Intravitreal Injection|"Intravitreal Aflibercept 2.0mg once~Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg."
112000|NCT01927419|O2|Outcome|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
112001|NCT01927419|O1|Outcome|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
112002|NCT01927419|E2|Reported Event|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
112003|NCT01927419|E1|Reported Event|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
112004|NCT01927120|B1|Baseline|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
112005|NCT01927120|P1|Participant Flow|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
112006|NCT01927120|O1|Outcome|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
112007|NCT01927120|O1|Outcome|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
112008|NCT01927120|O1|Outcome|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
112009|NCT01927120|O1|Outcome|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
112010|NCT01927120|O1|Outcome|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
112011|NCT01927120|O1|Outcome|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
112012|NCT01927120|O1|Outcome|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
112013|NCT01927120|O1|Outcome|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
112014|NCT01927120|O1|Outcome|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
112015|NCT01927120|O1|Outcome|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
112016|NCT01927120|O1|Outcome|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
112017|NCT01927120|O1|Outcome|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
112018|NCT01927120|E1|Reported Event|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
112019|NCT01927055|B4|Baseline|Total|Total of all reporting groups
112020|NCT01927055|B3|Baseline|Placebo|"Placebo~Placebo: Placebo to match droxidopa capsules and strength designations. 100, 200, 300, 400, 500, 600mg TID dosing for up to 12 weeks of treatment"
112021|NCT01927055|B2|Baseline|Droxidopa|"Droxidopa 100 mg, 200 mg, 300 mg~Droxidopa: 100 mg, 200 mg and 300 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 12 weeks of treatment"
112022|NCT01927055|B1|Baseline|Open-Label|Patients entered open label droxidopa dose titration, but did not proceed into the randomization phase.
112023|NCT01927055|P3|Participant Flow|Placebo|"Placebo~Placebo: Placebo to match droxidopa capsules and strength designations"
112024|NCT01927055|P2|Participant Flow|Droxidopa|"Droxidopa 100 mg, 200 mg, 300 mg~Droxidopa: 100 mg, 200 mg and 300 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 12 weeks of treatment"
112025|NCT01927055|P1|Participant Flow|Open-label Titration|"Droxidopa 100 mg, 200 mg~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 2 weeks of treatment"
112026|NCT01927055|O2|Outcome|Placebo|"Placebo~Placebo: Placebo to match droxidopa capsules and strength designations"
112027|NCT01927055|O1|Outcome|Droxidopa|"Droxidopa 100 mg, 200 mg, 300 mg~Droxidopa: Droxidopa at 100 mg, 200 mg, 300 mg"
112028|NCT01927055|E3|Reported Event|Placebo|"Placebo~Placebo: Placebo to match droxidopa capsules and strength designations"
112029|NCT01927055|E2|Reported Event|Droxidopa|"Droxidopa 100 mg, 200 mg, 300 mg~Droxidopa: 100 mg, 200 mg and 300 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 12 weeks of treatment"
112030|NCT01927055|E1|Reported Event|Open-label Titration|All patients treated with study drug during dose titration (1-14 days)
112031|NCT01926977|B3|Baseline|Total|Total of all reporting groups
112032|NCT01926977|B2|Baseline|Aflibercept 2.0mg Intravitreal Injection|"Intravitreal Aflibercept 2.0mg once~Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg."
112033|NCT01926977|B1|Baseline|Ranibizumab 0.5mg Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.5mg once~Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg."
112034|NCT01926977|P2|Participant Flow|Aflibercept 2.0mg Intravitreal Injection|"Intravitreal Aflibercept 2.0mg once~Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg."
112035|NCT01926977|P1|Participant Flow|Ranibizumab 0.5mg Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.5mg once~Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg."
112037|NCT01926977|O1|Outcome|Ranibizumab 0.5mg Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.5mg once~Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg."
112038|NCT01926977|O2|Outcome|Aflibercept 2.0mg Intravitreal Injection|"Intravitreal Aflibercept 2.0mg once~Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg."
112039|NCT01926977|O1|Outcome|Ranibizumab 0.5mg Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.5mg once~Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg."
112040|NCT01926977|E2|Reported Event|Aflibercept 2.0mg Intravitreal Injection|"Intravitreal Aflibercept 2.0mg once~Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg."
112041|NCT01926977|E1|Reported Event|Ranibizumab 0.5mg Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.5mg once~Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg."
112042|NCT01926782|B7|Baseline|Total|Total of all reporting groups
112043|NCT01926782|B6|Baseline|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112044|NCT01926782|B5|Baseline|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112045|NCT01926782|B4|Baseline|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
112046|NCT01926782|B3|Baseline|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112047|NCT01926782|B2|Baseline|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112048|NCT01926782|B1|Baseline|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
112049|NCT01926782|P6|Participant Flow|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112050|NCT01926782|P5|Participant Flow|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112051|NCT01926782|P4|Participant Flow|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
112052|NCT01926782|P3|Participant Flow|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112053|NCT01926782|P2|Participant Flow|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112054|NCT01926782|P1|Participant Flow|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
112055|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112056|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112057|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
112058|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112099|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
112726|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112059|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112060|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
112061|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112062|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112063|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
112064|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112065|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112066|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
112067|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112068|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112069|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
112070|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112071|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112072|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
112073|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112074|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112075|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
112076|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112077|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112078|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
112120|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
130312|NCT01836458|O2|Outcome|Dose 2: 20 mg|Single dose of KAE609 20 mg
112079|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112080|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112081|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
112082|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112083|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112084|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
112085|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112086|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112087|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
112088|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112089|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112090|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
112091|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112092|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112093|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
112094|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112095|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112096|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
112097|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112098|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112100|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112101|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112102|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
112103|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112104|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112105|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
112106|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112107|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112108|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
112109|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112110|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112111|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
112112|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112113|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112114|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
112115|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112116|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112117|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
112118|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112119|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112121|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112122|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8"
112123|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
112124|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112125|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112126|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
112127|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112128|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112129|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
112130|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112131|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112132|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
112133|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112134|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112135|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
112136|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112137|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112138|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
112139|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112140|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112141|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
112142|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8
112143|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112144|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
112145|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112146|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112147|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
112148|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8
112149|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112150|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
112151|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112152|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112153|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
112154|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112155|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112156|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
112157|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112158|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112159|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
112160|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112201|NCT01926782|E1|Reported Event|Placebo Q2W|Two SC injections of placebo (for alirocumab) Q2W with or without stable statin therapy for 48 weeks.
130313|NCT01836458|O1|Outcome|Dose 1: 30 mg|Single dose of KAE609 30 mg
112161|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112162|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
112163|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112164|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112165|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
112166|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112167|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112168|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
112169|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112170|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112171|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
112172|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112173|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8"
112174|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
112175|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112176|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112177|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
112178|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8
112179|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112180|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
112236|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112181|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112182|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112183|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
112184|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112185|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112186|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
112187|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112188|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112189|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
112190|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112191|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112192|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
112193|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112194|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112195|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
112196|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112197|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
112198|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
112199|NCT01926782|E3|Reported Event|Alirocumab 300 mg Q4W/Up 150 mg Q2W|Two SC injections of Alirocumab 300 mg Q4W alternating with two SC injections of placebo Q4W with or without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112200|NCT01926782|E2|Reported Event|Alirocumab 75 mg Q2W/Up 150 mg Q2W|One SC injection of Alirocumab 150 mg Q4W alternating with 2 SC injections of placebo Q4W with or without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
112202|NCT01926626|B1|Baseline|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
112203|NCT01926626|P1|Participant Flow|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
112204|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
112205|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
112206|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
112207|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
112208|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
112209|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
112210|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
112211|NCT01926626|E1|Reported Event|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
112212|NCT01926119|B1|Baseline|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of Theta Burst Stimulation followed by High frequency stimulation~Transcranial Magnetic Stimulation"
112213|NCT01926119|P1|Participant Flow|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of Theta Burst Stimulation followed by High frequency stimulation~Transcranial Magnetic Stimulation"
112214|NCT01926119|O1|Outcome|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.~Transcranial Magnetic Stimulation"
112215|NCT01926119|O1|Outcome|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.~Transcranial Magnetic Stimulation"
112216|NCT01926119|O1|Outcome|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.~Transcranial Magnetic Stimulation"
112217|NCT01926119|O1|Outcome|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.~Transcranial Magnetic Stimulation"
112218|NCT01926119|O1|Outcome|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.~Transcranial Magnetic Stimulation"
112219|NCT01926119|O1|Outcome|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.~Transcranial Magnetic Stimulation"
112220|NCT01926119|O1|Outcome|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.~Transcranial Magnetic Stimulation"
112221|NCT01926119|E1|Reported Event|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of Theta Burst Stimulation followed by High frequency stimulation~Transcranial Magnetic Stimulation"
112222|NCT01926015|B3|Baseline|Total|Total of all reporting groups
112223|NCT01926015|B2|Baseline|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112224|NCT01926015|B1|Baseline|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112225|NCT01926015|P2|Participant Flow|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112226|NCT01926015|P1|Participant Flow|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112227|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112228|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112229|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112230|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112231|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112232|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112233|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112234|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112235|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112294|NCT01925469|E2|Reported Event|Saline Spray|"A saline placebo spray will be used in the placebo group.~Saline spray: A saline spray will be used in the placebo group"
112237|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112238|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112239|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112240|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112241|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112242|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112243|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112244|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112245|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112246|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112247|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112248|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112249|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112250|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112251|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112252|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112253|NCT01926015|E2|Reported Event|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112254|NCT01926015|E1|Reported Event|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
112255|NCT01925781|B3|Baseline|Total|Total of all reporting groups
112256|NCT01925781|B2|Baseline|Nicotine Polacrilex|"Nicotine Replacement gum~Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling"
112257|NCT01925781|B1|Baseline|e-Cigarette|STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
112258|NCT01925781|P2|Participant Flow|Nicotine Polacrilex|"Nicotine Replacement gum~Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling"
112259|NCT01925781|P1|Participant Flow|e-Cigarette|STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
112260|NCT01925781|O2|Outcome|Nicotine Polacrilex|"Nicotine Replacement gum~Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling"
112261|NCT01925781|O1|Outcome|e-Cigarette|STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
112262|NCT01925781|O2|Outcome|Nicotine Polacrilex|"Nicotine Replacement gum~Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling"
112263|NCT01925781|O1|Outcome|e-Cigarette|STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
112264|NCT01925781|E2|Reported Event|Nicotine Polacrilex|"Nicotine Replacement gum~Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling"
112265|NCT01925781|E1|Reported Event|e-Cigarette|STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
112266|NCT01925768|B3|Baseline|Total|Total of all reporting groups
112267|NCT01925768|B2|Baseline|Apremilast (APR) 30 mg|Participants randomized to receive 30 mg apremilast (APR) tablets BID during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator. Apremilast treated participants who EE continued to receive 30 mg apremilast BID in a blinded fashion.
112268|NCT01925768|B1|Baseline|Placebo (PBO)|Participants randomized to receive placebo tablets twice daily (BID) during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who early escaped were transitioned to apremilast 30 mg BID in a blinded fashion.
112269|NCT01925768|P2|Participant Flow|Apremilast (APR) 30 mg|Participants randomized to receive 30 mg apremilast (APR) tablets BID during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator. Apremilast treated participants who EE continued to receive 30 mg apremilast BID in a blinded fashion.
112270|NCT01925768|P1|Participant Flow|Placebo (PBO)|Participants randomized to receive placebo tablets twice daily (BID) during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who early escaped were transitioned to apremilast 30 mg BID in a blinded fashion.
112271|NCT01925768|O2|Outcome|Apremilast (APR) 30 mg|Participants randomized to receive 30 mg apremilast (APR) tablets BID during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator. Apremilast treated participants who EE continued to receive 30 mg apremilast BID in a blinded fashion.
112272|NCT01925768|O1|Outcome|Placebo (PBO)|Participants randomized to receive placebo tablets twice daily (BID) during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who early escaped were transitioned to apremilast 30 mg BID in a blinded fashion.
112273|NCT01925768|O2|Outcome|Apremilast (APR) 30 mg|Participants randomized to receive 30 mg apremilast (APR) tablets BID during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator. Apremilast treated participants who EE continued to receive 30 mg apremilast BID in a blinded fashion.
112274|NCT01925768|O1|Outcome|Placebo (PBO)|Participants randomized to receive placebo tablets twice daily (BID) during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who early escaped were transitioned to apremilast 30 mg BID in a blinded fashion.
112275|NCT01925768|E2|Reported Event|Week 24: Apremilast 30 mg|Participants randomized to receive 30 mg apremilast BID during the 24 week placebo controlled period.
112276|NCT01925768|E1|Reported Event|Week 24: Placebo|Participants randomized to receive placebo tablets twice daily (BID) during the placebo-controlled phase. Includes data through week 16 for participants who early escaped and through week 24 for all other participants.
112277|NCT01925703|B1|Baseline|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
112278|NCT01925703|P1|Participant Flow|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
112279|NCT01925703|O1|Outcome|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
112280|NCT01925703|O1|Outcome|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
112281|NCT01925703|O1|Outcome|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
112282|NCT01925703|E1|Reported Event|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
112283|NCT01925469|B3|Baseline|Total|Total of all reporting groups
112284|NCT01925469|B2|Baseline|Saline Spray|"A saline placebo spray will be used in the placebo group.~Saline spray: A saline spray will be used in the placebo group"
112285|NCT01925469|B1|Baseline|Benzocaine|"Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.~Benzocaine"
112286|NCT01925469|P2|Participant Flow|Saline Spray|"A saline placebo spray will be used in the placebo group.~Saline spray: A saline spray will be used in the placebo group"
112287|NCT01925469|P1|Participant Flow|Benzocaine|"Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.~Benzocaine"
112288|NCT01925469|O2|Outcome|Saline Spray|"A saline placebo spray will be used in the placebo group.~Saline spray: A saline spray will be used in the placebo group"
112289|NCT01925469|O1|Outcome|Benzocaine|"Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.~Benzocaine"
112290|NCT01925469|O2|Outcome|Saline Spray|"A saline placebo spray will be used in the placebo group.~Saline spray: A saline spray will be used in the placebo group"
112291|NCT01925469|O1|Outcome|Benzocaine|"Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.~Benzocaine"
112292|NCT01925469|O2|Outcome|Saline Spray|"A saline placebo spray will be used in the placebo group.~Saline spray: A saline spray will be used in the placebo group"
112293|NCT01925469|O1|Outcome|Benzocaine|"Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.~Benzocaine"
112295|NCT01925469|E1|Reported Event|Benzocaine|"Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.~Benzocaine"
112296|NCT01925417|B1|Baseline|RBX2660 (Microbiota Suspension)|Open-label; all subjects received RBX2660
112297|NCT01925417|P1|Participant Flow|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
112298|NCT01925417|O1|Outcome|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
112299|NCT01925417|O1|Outcome|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
112300|NCT01925417|O1|Outcome|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
112301|NCT01925417|O1|Outcome|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
112302|NCT01925417|E1|Reported Event|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
112303|NCT01925274|B4|Baseline|Total|Total of all reporting groups
112304|NCT01925274|B3|Baseline|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112305|NCT01925274|B2|Baseline|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
112306|NCT01925274|B1|Baseline|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112307|NCT01925274|P3|Participant Flow|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112308|NCT01925274|P2|Participant Flow|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
112309|NCT01925274|P1|Participant Flow|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112310|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
112311|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112312|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112727|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112313|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
112314|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112315|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112316|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
112317|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112318|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112319|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112320|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112321|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112322|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112364|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
112397|NCT01925209|O1|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
112728|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112323|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112324|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112325|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112326|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112327|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112328|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112329|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112330|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112331|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112332|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112398|NCT01925209|O4|Outcome|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112729|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112333|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112334|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112335|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112336|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112337|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112338|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112339|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112340|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112341|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112342|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112399|NCT01925209|O3|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112730|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112343|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112344|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112345|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112346|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112347|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112348|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112349|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
112350|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112351|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112352|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
112376|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112400|NCT01925209|O2|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112353|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112354|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112355|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
112356|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112357|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112358|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
112359|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112360|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112361|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
112362|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112363|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112396|NCT01925209|O2|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112731|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112365|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112366|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112367|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
112368|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112369|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112370|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
112371|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112372|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
112373|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112374|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
112375|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112447|NCT01925170|O3|Outcome|Molecular Breast Imaging Alone|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
112377|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
112378|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112379|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112380|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
112381|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112382|NCT01925274|E3|Reported Event|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28 day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF 05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112383|NCT01925274|E2|Reported Event|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
112384|NCT01925274|E1|Reported Event|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
112385|NCT01925209|B5|Baseline|Total|Total of all reporting groups
112386|NCT01925209|B4|Baseline|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112387|NCT01925209|B3|Baseline|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112388|NCT01925209|B2|Baseline|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112389|NCT01925209|B1|Baseline|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
112390|NCT01925209|P4|Participant Flow|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112391|NCT01925209|P3|Participant Flow|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112392|NCT01925209|P2|Participant Flow|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112393|NCT01925209|P1|Participant Flow|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
112394|NCT01925209|O4|Outcome|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112395|NCT01925209|O3|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112732|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112401|NCT01925209|O1|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
112402|NCT01925209|O4|Outcome|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112403|NCT01925209|O3|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112404|NCT01925209|O2|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112405|NCT01925209|O1|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
112406|NCT01925209|O4|Outcome|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112407|NCT01925209|O3|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112408|NCT01925209|O2|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112409|NCT01925209|O1|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
112410|NCT01925209|O4|Outcome|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112411|NCT01925209|O3|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112412|NCT01925209|O2|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112413|NCT01925209|O1|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
112414|NCT01925209|O4|Outcome|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112415|NCT01925209|O3|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112416|NCT01925209|O2|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112417|NCT01925209|O1|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
112418|NCT01925209|E4|Reported Event|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112419|NCT01925209|E3|Reported Event|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112420|NCT01925209|E2|Reported Event|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
112421|NCT01925209|E1|Reported Event|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
112422|NCT01925183|B3|Baseline|Total|Total of all reporting groups
112423|NCT01925183|B2|Baseline|48 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
112424|NCT01925183|B1|Baseline|28 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
112425|NCT01925183|P2|Participant Flow|48 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
112426|NCT01925183|P1|Participant Flow|28 Weeks of Treatment Duration|"All patients will receive 4 weeks of pegylated interferon/ribavirin (PEGIFN/RBV) lead-in. Patients with undetectable hepatitis C virus (HCV)-RNA at treatment week 8 will be treated with 24 weeks of boceprevir (BOC)/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
112448|NCT01925170|O2|Outcome|Mammography With Adjunct MBI|For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.
112449|NCT01925170|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
112427|NCT01925183|O2|Outcome|48 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
112428|NCT01925183|O1|Outcome|28 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
112429|NCT01925183|O2|Outcome|48 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
112430|NCT01925183|O1|Outcome|28 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
112431|NCT01925183|E2|Reported Event|48 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
112432|NCT01925183|E1|Reported Event|28 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
112433|NCT01925170|B1|Baseline|Mammography and Molecular Breast Imaging|"Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (8-mCi) Technetium (99mTc) sestamibi injection.~Molecular Breast Imaging: Molecular breast imaging is a new nuclear medicine technique for imaging the breast. It uses small field of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.~Conventional Mammography: Mammography is the process of using low-energy X-rays (usually around 30 kVp) to examine the human breast and is used as a diagnostic and a screening tool.~Technetium (99mTc) sestamibi: Technetium (99mTc) sestamibi is a pharmaceutical agent used in nuclear medicine imaging. The drug is a coordination complex consisting of the radioisotope technetium-99m bound to six methoxyisobutylisonitrile (MIBI) ligands."
112434|NCT01925170|P1|Participant Flow|Mammography and Molecular Breast Imaging|"Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (8-mCi) Technetium (99mTc) sestamibi injection.~Molecular Breast Imaging: Molecular breast imaging is a new nuclear medicine technique for imaging the breast. It uses small field of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.~Conventional Mammography: Mammography is the process of using low-energy X-rays (usually around 30 kVp) to examine the human breast and is used as a diagnostic and a screening tool.~Technetium (99mTc) sestamibi: Technetium (99mTc) sestamibi is a pharmaceutical agent used in nuclear medicine imaging. The drug is a coordination complex consisting of the radioisotope technetium-99m bound to six methoxyisobutylisonitrile (MIBI) ligands."
112435|NCT01925170|O3|Outcome|Molecular Breast Imaging Alone|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
112436|NCT01925170|O2|Outcome|Mammography With Adjunct MBI|For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.
112437|NCT01925170|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
112438|NCT01925170|O3|Outcome|Molecular Breast Imaging Alone|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
112439|NCT01925170|O2|Outcome|Mammography With Adjunct MBI|For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.
112440|NCT01925170|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
112441|NCT01925170|O3|Outcome|Molecular Breast Imaging Alone|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
112442|NCT01925170|O2|Outcome|Mammography With Adjunct MBI|For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.
112443|NCT01925170|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
112444|NCT01925170|O3|Outcome|Molecular Breast Imaging Alone|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
112445|NCT01925170|O2|Outcome|Mammography With Adjunct MBI|For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.
112446|NCT01925170|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
112450|NCT01925170|E1|Reported Event|Mammography and Molecular Breast Imaging|Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (8-mCi) Technetium (99mTc) sestamibi injection.
112451|NCT01925144|B1|Baseline|Baricitinib + Omeprazole|"10 mg baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 10 in Period 2.~40 mg omeprazole capsule administered orally, QD, for 8 days (Days 3 through 10) in Period 2."
112452|NCT01925144|P1|Participant Flow|Baricitinib + Omeprazole|"10 milligram (mg) baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 10 in Period 2.~40 mg omeprazole capsule administered orally, once daily (QD), for 8 days (Days 3 through 10) in Period 2."
112453|NCT01925144|O2|Outcome|Baricitinib + Omeprazole|"10 mg baricitinib tablet administered orally, once, on Day 10 in Period 2.~40 mg omeprazole capsule administered orally, QD, for 8 days (Days 3 through 10) in Period 2."
112454|NCT01925144|O1|Outcome|Baricitinib|10 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.
112455|NCT01925144|O2|Outcome|Baricitinib + Omeprazole|"10 mg baricitinib tablet administered orally, once, on Day 10 in Period 2.~40 mg omeprazole capsule administered orally, QD, for 8 days (Days 3 through 10) in Period 2."
112456|NCT01925144|O1|Outcome|Baricitinib|10 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.
112457|NCT01925144|O2|Outcome|Baricitinib + Omeprazole|"10 mg baricitinib tablet administered orally, once, on Day 10 in Period 2.~40 mg omeprazole capsule administered orally, QD, for 8 days (Days 3 through 10) in Period 2."
112458|NCT01925144|O1|Outcome|Baricitinib|10 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.
112459|NCT01925144|E3|Reported Event|Baricitinib + Omeprazole|"10 mg baricitinib tablet administered orally once with 40 mg omeprazole capsule orally once, on Day 10 in Period 2.~Adverse events are reported from postdose on Day 10 up to Day 24."
112460|NCT01925144|E2|Reported Event|Omeprazole|"40 mg omeprazole capsule administered orally, QD, on Days 3 through 9 in Period 2.~Adverse events are reported from postdose on Day 3 through predose on Day 10."
112461|NCT01925144|E1|Reported Event|Baricitinib|"10 mg baricitinib tablet administered orally once, on Day 1 in Period 1.~Adverse events are reported from baseline through predose on Day 3."
112462|NCT01924975|B3|Baseline|Total|Total of all reporting groups
112463|NCT01924975|B2|Baseline|Ultrasound Group|"An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~ultrasound with a linear transducer (L15-7io): Portable, bed-side ultrasound to detect saphenous vein~A 22 or 24 G intravenous catheter"
112464|NCT01924975|B1|Baseline|Landmark Group|"An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~A 22 or 24 G intravenous catheter"
112465|NCT01924975|P2|Participant Flow|Ultrasound Group|"An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~ultrasound with a linear transducer (L15-7io): Portable, bed-side ultrasound to detect saphenous vein~A 22 or 24 G intravenous catheter"
112466|NCT01924975|P1|Participant Flow|Landmark Group|"An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~A 22 or 24 G intravenous catheter"
112467|NCT01924975|O2|Outcome|Ultrasound Group|"An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~ultrasound with a linear transducer (L15-7io): Portable, bed-side ultrasound to detect saphenous vein~A 22 or 24 G intravenous catheter"
112468|NCT01924975|O1|Outcome|Landmark Group|"An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~A 22 or 24 G intravenous catheter"
112469|NCT01924975|O2|Outcome|Ultrasound Group|"An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~ultrasound with a linear transducer (L15-7io): Portable, bed-side ultrasound to detect saphenous vein~A 22 or 24 G intravenous catheter"
112470|NCT01924975|O1|Outcome|Landmark Group|"An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~A 22 or 24 G intravenous catheter"
112471|NCT01924975|O2|Outcome|Ultrasound Group|"An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~ultrasound with a linear transducer (L15-7io): Portable, bed-side ultrasound to detect saphenous vein~A 22 or 24 G intravenous catheter"
112511|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
112733|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112472|NCT01924975|O1|Outcome|Landmark Group|"An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~A 22 or 24 G intravenous catheter"
112473|NCT01924975|E2|Reported Event|Ultrasound Group|"An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~ultrasound with a linear transducer (L15-7io): Portable, bed-side ultrasound to detect saphenous vein~A 22 or 24 G intravenous catheter"
112474|NCT01924975|E1|Reported Event|Landmark Group|"An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~A 22 or 24 G intravenous catheter"
112475|NCT01924949|B1|Baseline|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
112476|NCT01924949|P1|Participant Flow|LDV/SOF 12 Weeks|Ledipasvir (LDV)/sofosbuvir (SOF) 90/400 mg fixed-dose combination (FDC) tablet once daily for 12 weeks
112477|NCT01924949|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
112478|NCT01924949|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
112479|NCT01924949|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
112480|NCT01924949|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
112481|NCT01924949|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
112482|NCT01924949|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
112483|NCT01924949|E1|Reported Event|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
112484|NCT01924871|B3|Baseline|Total|Total of all reporting groups
112485|NCT01924871|B2|Baseline|Desflurane With Remifentanil Group|"1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil~Desflurane with remifentanil: During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil"
112486|NCT01924871|B1|Baseline|Desflurane Group|"1.5 MAC desflurane until extubation~Desflurane: During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane"
112487|NCT01924871|P2|Participant Flow|Desflurane With Remifentanil Group|"1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil~Desflurane with remifentanil: During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil"
112488|NCT01924871|P1|Participant Flow|Desflurane Group|"1.5 MAC desflurane until extubation~Desflurane: During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane"
112489|NCT01924871|O2|Outcome|Desflurane With Remifentanil Group|"1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil~Desflurane with remifentanil: During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil"
112490|NCT01924871|O1|Outcome|Desflurane Group|"1.5 MAC desflurane until extubation~Desflurane: During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane"
112491|NCT01924871|E2|Reported Event|Desflurane With Remifentanil Group|"1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil~Desflurane with remifentanil: During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil"
112492|NCT01924871|E1|Reported Event|Desflurane Group|"1.5 MAC desflurane until extubation~Desflurane: During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane"
112493|NCT01924767|B6|Baseline|Total|Total of all reporting groups
112494|NCT01924767|B5|Baseline|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily in the morning.
112495|NCT01924767|B4|Baseline|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily in the morning.
112496|NCT01924767|B3|Baseline|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily in the morning.
112497|NCT01924767|B2|Baseline|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily in the morning.
112498|NCT01924767|B1|Baseline|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
112499|NCT01924767|P5|Participant Flow|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
112500|NCT01924767|P4|Participant Flow|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
112501|NCT01924767|P3|Participant Flow|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
112502|NCT01924767|P2|Participant Flow|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
112503|NCT01924767|P1|Participant Flow|Placebo|Patients were treated with matching placebo as tablet once daily (qd) in the morning.
112504|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
112505|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
112506|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
112507|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
112508|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily (qd) in the morning.
112509|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
112510|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
130314|NCT01836458|O4|Outcome|Dose 4: 15 mg|Single dose of KAE609 15 mg
112512|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
112513|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily (qd) in the morning.
112514|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
112515|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
112516|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
112517|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
112518|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
112519|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
112520|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
112521|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
112522|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
112523|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
112524|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
112525|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
112526|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
112527|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
112528|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
112529|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
112530|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
112531|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
112532|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
112533|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
112534|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
112535|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
112536|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
112537|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
112538|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
112539|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
112540|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
112541|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
112542|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
112543|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
112544|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
112545|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
112546|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
112547|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
112548|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
112549|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
112550|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
112551|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
112552|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
112553|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
112554|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
112555|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
112556|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
112557|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
112558|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
112559|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
112560|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
112561|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
112562|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
112563|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
112564|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
112565|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
112566|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
112567|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
112568|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
112569|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
112570|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
112571|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
112572|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
112573|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
112574|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
112575|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
112576|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
112577|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
112578|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
112579|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
112580|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
112581|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
112582|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
112583|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
112584|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
112585|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
112586|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
112587|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
112588|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
112589|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
112590|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
112591|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
112592|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
112593|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
112594|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
112595|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
112596|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
112597|NCT01924767|E5|Reported Event|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily in the morning.
112598|NCT01924767|E4|Reported Event|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily in the morning.
112599|NCT01924767|E3|Reported Event|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily in the morning.
112600|NCT01924767|E2|Reported Event|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily in the morning.
112601|NCT01924767|E1|Reported Event|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
112602|NCT01924559|B1|Baseline|SALT and Biohazard Gear|All participants were tested on three intubation devices in either standard clothing or biohazard gear.
112603|NCT01924559|P1|Participant Flow|All Study Participants|All participants were randomized into groups testing three intubation devices while wearing standard clothing or biohazard gear..
112604|NCT01924559|O6|Outcome|SALT and Biohazard Gear|"Residents will intubate manikins using SALT while wearing biohazard gear.~Biohazard gear~SALT"
112605|NCT01924559|O5|Outcome|SALT & Standard Clothing|"Residents will intubate manikins using SALT while wearing standard clothing.~standard clothing~SALT"
112606|NCT01924559|O4|Outcome|Glidescope & Biohazard Gear|"Residents will intubate manikins using Glidescope while wearing Biohazard gear.~Biohazard gear~Glidescope"
112607|NCT01924559|O3|Outcome|Glidescope & Standard Clothing|"Residents will intubate manikins using Glidescope while wearing standard clothing.~standard clothing~Glidescope"
112608|NCT01924559|O2|Outcome|DL & Biohazard Gear|"Residents will intubate manikins using DL while in Biohazard gear.~Biohazard gear~DL"
112609|NCT01924559|O1|Outcome|DL & Standard Clothing|"Residents will intubate manikin using DL while wearing standard clothing.~standard clothing~DL"
112610|NCT01924559|E6|Reported Event|SALT and Biohazard Gear|"Residents will intubate manikins using SALT while wearing biohazard gear.~Biohazard gear~SALT No adverse events"
112611|NCT01924559|E5|Reported Event|SALT & Standard Clothing|"Residents will intubate manikins using SALT while wearing standard clothing.~standard clothing~SALT"
112612|NCT01924559|E4|Reported Event|Glidescope & Biohazard Gear|"Residents will intubate manikins using Glidescope while wearing Biohazard gear.~Biohazard gear~GlideScope"
112613|NCT01924559|E3|Reported Event|Glidescope & Standard Clothing|"Residents will intubate manikins using Glidescope while wearing standard clothing.~standard clothing~GlideScope"
112614|NCT01924559|E2|Reported Event|DL & Biohazard Gear|"Residents will intubate manikins using DL while in Biohazard gear.~Biohazard gear~DL"
112615|NCT01924559|E1|Reported Event|DL & Standard Clothing|"Residents will intubate manikin using DL while wearing standard clothing.~standard clothing~DL"
112616|NCT01924390|B3|Baseline|Total|Total of all reporting groups
112617|NCT01924390|B2|Baseline|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone~Combination of Mineralized and demineralized freeze-dried bone allograft alone"
112618|NCT01924390|B1|Baseline|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone~Mineralized freeze-dried bone allograft alone"
112619|NCT01924390|P2|Participant Flow|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone~Combination of Mineralized and demineralized freeze-dried bone allograft alone"
112620|NCT01924390|P1|Participant Flow|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone~Mineralized freeze-dried bone allograft alone"
112621|NCT01924390|O2|Outcome|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone~Combination of Mineralized and demineralized freeze-dried bone allograft alone"
112622|NCT01924390|O1|Outcome|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone~Mineralized freeze-dried bone allograft alone"
112623|NCT01924390|O2|Outcome|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone~Combination of Mineralized and demineralized freeze-dried bone allograft alone"
112624|NCT01924390|O1|Outcome|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone~Mineralized freeze-dried bone allograft alone"
112625|NCT01924390|O2|Outcome|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone~Combination of Mineralized and demineralized freeze-dried bone allograft alone"
112626|NCT01924390|O1|Outcome|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone~Mineralized freeze-dried bone allograft alone"
112627|NCT01924390|E2|Reported Event|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone~Combination of Mineralized and demineralized freeze-dried bone allograft alone"
112628|NCT01924390|E1|Reported Event|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone~Mineralized freeze-dried bone allograft alone"
112629|NCT01924364|B1|Baseline|Fat Grafting|Tissue Genesis Cell Isolation System™ (CIS): In this study, we will concentrate the adipose stromal cells (ASCs) in the fat graft material to assess whether this modification will increase fat graft retention over time. The concentrated fat to be injected into the subject from the fat grafting procedure will be processed by the Tissue Genesis Cell Isolation System™ (CIS) device. The volume retention in areas treated with ASC concentrated fat grafts will be compared with regions treated with standard fat grafts in the same patient. Additionally, data from our current study assessing volume retention after fat grafting for facial deformities (IRB # PRO09060101) will be used for comparison.
112630|NCT01924364|P1|Participant Flow|Fat Grafting|Same patient received either fat graft treatment supplemented with TGI or no TGI, randomized per site.
112631|NCT01924364|O2|Outcome|Standard_Stem Cell Viability Yield|%age of cells yield/volume of fat tissue
112632|NCT01924364|O1|Outcome|TGI_Stem Cell Viability Yield|%age of cells yield/volume of fat tissue
112633|NCT01924364|O10|Outcome|Standard_Facial Volume at 24 Month PO|Standard_Facial volume at 24 month PO
112634|NCT01924364|O9|Outcome|Standard_Facial Volume at 12 Month PO|Standard_Facial volume at 12 month PO
112635|NCT01924364|O8|Outcome|Standard_Facial Volume at 9 Month PO|Facial volume at 9 month PO
112636|NCT01924364|O7|Outcome|Standard_Facial Volume at 3 Month PO|Standard_Facial volume at 3 month PO
112637|NCT01924364|O6|Outcome|Standard_Fat Volume Injected|
112638|NCT01924364|O5|Outcome|TGI_Facial Volume at 24 Month PO|Facial volume at 24 month PO
112639|NCT01924364|O4|Outcome|TGI_Facial Volume at 12 Month PO|Facial volume at 12 month post-operative
112640|NCT01924364|O3|Outcome|TGI_Facial Volume at 9 Month PO|Facial volume at 9 month PO
112641|NCT01924364|O2|Outcome|TGI_Facial Volume at 3 Month PO|Facial volume at 3 month post-operative
112642|NCT01924364|O1|Outcome|TGI_Fat Volume Injected|
112643|NCT01924364|E1|Reported Event|Fat Grafting|Tissue Genesis Cell Isolation System™ (TGI CIS): In this study, we will concentrate the adipose stromal cells (ASCs) in the fat graft material to assess whether this modification will increase fat graft retention over time. The concentrated fat to be injected into the subject from the fat grafting procedure will be processed by the Tissue Genesis Cell Isolation System™ (TGI CIS) device. The volume retention in areas treated with ASC concentrated fat grafts will be compared with regions treated with standard fat grafts in the same patient.
112644|NCT01924299|B3|Baseline|Total|Total of all reporting groups
112714|NCT01923740|P2|Participant Flow|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112715|NCT01923740|P1|Participant Flow|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112645|NCT01924299|B2|Baseline|Baricitinib + Fluconazole (Group B)|"10 mg baricitinib administered orally once on Day 1 of Period 1 and on Day 7 of Period 2.~400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2."
112646|NCT01924299|B1|Baseline|Baricitinib + Ketoconazole (Group A)|"10 mg baricitinib administered orally once on Day 1 of Period 1 and on Day 6 of Period 2.~400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2."
112647|NCT01924299|P2|Participant Flow|Baricitinib + Fluconazole (Group B)|"10 mg baricitinib administered orally once on Day 1 of Period 1 and on Day 7 of Period 2.~400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2."
112648|NCT01924299|P1|Participant Flow|Baricitinib + Ketoconazole (Group A)|"10 milligrams (mg) baricitinib administered orally once on Day 1 of Period 1 and on Day 6 of Period 2.~400 mg ketoconazole administered orally once daily (QD) for 6 days (Day 3 through Day 8) in Period 2."
112649|NCT01924299|O2|Outcome|Baricitinib + Fluconazole (Group B)|10 mg baricitinib administered orally once on Day 7 of Period 2. 400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2.
112650|NCT01924299|O1|Outcome|Baricitinib (Group B)|10 mg baricitinib administered orally once on Day 1 of Period 1.
112651|NCT01924299|O2|Outcome|Baricitinib + Ketoconazole (Group A)|10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2.
112652|NCT01924299|O1|Outcome|Baricitinib (Group A)|10 mg baricitinib administered orally once on Day 1 of Period 1.
112653|NCT01924299|O2|Outcome|Baricitinib + Fluconazole (Group B)|10 mg baricitinib administered orally once on Day 7 of Period 2. 400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2.
112654|NCT01924299|O1|Outcome|Baricitinib (Group B)|10 mg baricitinib administered orally once on Day 1 of Period 1.
112655|NCT01924299|O2|Outcome|Baricitinib + Ketoconazole (Group A)|10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2.
112656|NCT01924299|O1|Outcome|Baricitinib (Group A)|10 mg baricitinib administered orally once on Day 1 of Period 1.
112657|NCT01924299|O2|Outcome|Baricitinib + Fluconazole (Group B)|10 mg baricitinib administered orally once on Day 7 of Period 2. 400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2.
112658|NCT01924299|O1|Outcome|Baricitinib (Group B)|10 mg baricitinib administered orally once on Day 1 of Period 1.
112659|NCT01924299|O2|Outcome|Baricitinib + Ketoconazole (Group A)|10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2.
112660|NCT01924299|O1|Outcome|Baricitinib (Group A)|10 mg baricitinib administered orally once on Day 1 of Period 1.
112661|NCT01924299|E6|Reported Event|Baricitinib + Fluconazole (Group B)|10 mg baricitinib administered orally once on Day 7 of Period 2. 200 mg fluconazole administered orally QD on Day 7 through Day 9 in Period 2. Adverse events are reported from postdose on Day 7 up to Day 23.
112662|NCT01924299|E5|Reported Event|Fluconazole (Group B)|"400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD on Day 4 through Day 6 in Period 2.~Adverse events are reported from postdose on Day 3 through predose on Day 7."
112663|NCT01924299|E4|Reported Event|Baricitinib (Group B)|10 mg baricitinib administered orally once on Day 1 of Period 1. Adverse events are reported from baseline through predose on Day 3.
112664|NCT01924299|E3|Reported Event|Baricitinib + Ketoconazole (Group A)|"10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg ketoconazole administered orally QD on Day 6 through Day 8 in Period 2.~Adverse events are reported from postdose on Day 6 up to Day 22."
112665|NCT01924299|E2|Reported Event|Ketoconazole (Group A)|400 mg ketoconazole administered orally QD on Day 3 through Day 5 in Period 2. Adverse events are reported from postdose on Day 3 through predose on Day 6.
112666|NCT01924299|E1|Reported Event|Baricitinib (Group A)|10 mg baricitinib administered orally once on Day 1 of Period 1. Adverse events are reported from baseline through predose on Day 3.
112667|NCT01924182|B3|Baseline|Total|Total of all reporting groups
112668|NCT01924182|B2|Baseline|Conventional Medical Management|Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
112669|NCT01924182|B1|Baseline|IT Group (SynchroMed/Intrathecal Morphine Sulfate)|"Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control.~SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control."
112670|NCT01924182|P2|Participant Flow|Conventional Medical Management|Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
112671|NCT01924182|P1|Participant Flow|IT Group (SynchroMed/Intrathecal Morphine Sulfate)|"Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control.~SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control."
112716|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112672|NCT01924182|O2|Outcome|Conventional Medical Management|Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
112673|NCT01924182|O1|Outcome|IT Group (SynchroMed/Intrathecal Morphine Sulfate)|"Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control.~SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control."
112674|NCT01924182|O2|Outcome|Conventional Medical Management|Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
112675|NCT01924182|O1|Outcome|IT Group (SynchroMed/Intrathecal Morphine Sulfate)|"Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control.~SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control."
112676|NCT01924182|O2|Outcome|Conventional Medical Management|Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
112677|NCT01924182|O1|Outcome|IT Group (SynchroMed/Intrathecal Morphine Sulfate)|"Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control.~SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control."
112678|NCT01924182|O2|Outcome|Conventional Medical Management|Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
112679|NCT01924182|O1|Outcome|IT Group (SynchroMed/Intrathecal Morphine Sulfate)|"Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control.~SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control."
112680|NCT01924182|E2|Reported Event|Conventional Medical Management|Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
112681|NCT01924182|E1|Reported Event|IT Group (SynchroMed/Intrathecal Morphine Sulfate)|"Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control.~SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control."
112682|NCT01924169|B1|Baseline|Lenalidomide|"Lenalidomide administered at the dose of 5 mg/day three times a day for three months. If IgG levels improve by at least 25% of baseline, lenalidomide administration continued for 3 months on, and 3 months off for 2 years. If IgG levels do not improve, frequency of lenalidomide increased to 5 mg/day for additional 3 months and if response is achieved, lenalidomide continued at 5mg/day 3 month on/3 month off for a total of 2 years.~Seasonal influenza vaccination (Trivalent Influenza Vaccine, Fluzone High Dose) administered yearly, during the fall/winter season and pneumococcal immunization (Pneumococcal Polysaccharide Vaccine, Pneumovax) administered once between month 6 and month 21."
112683|NCT01924169|P1|Participant Flow|Lenalidomide|"Lenalidomide administered at the dose of 5 mg/day three times a day for three months. If IgG levels improve by at least 25% of baseline, lenalidomide administration continued for 3 months on, and 3 months off for 2 years. If Immunoglobulin G (IgG) levels do not improve, frequency of lenalidomide increased to 5 mg/day for additional 3 months and if response is achieved, lenalidomide continued at 5mg/day 3 month on/3 month off for a total of 2 years.~Seasonal influenza vaccination (Trivalent Influenza Vaccine, Fluzone High Dose) administered yearly, during the fall/winter season and pneumococcal immunization (Pneumococcal Polysaccharide Vaccine, Pneumovax) administered once between month 6 and month 21."
112717|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112718|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112719|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112720|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112721|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112722|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112684|NCT01924169|O1|Outcome|Lenalidomide|"Lenalidomide administered at the dose of 5 mg/day three times a day for three months. If IgG levels improve by at least 25% of baseline, lenalidomide administration continued for 3 months on, and 3 months off for 2 years. If IgG levels do not improve, frequency of lenalidomide increased to 5 mg/day for additional 3 months and if response is achieved, lenalidomide continued at 5mg/day 3 month on/3 month off for a total of 2 years.~Seasonal influenza vaccination (Trivalent Influenza Vaccine, Fluzone High Dose) administered yearly, during the fall/winter season and pneumococcal immunization (Pneumococcal Polysaccharide Vaccine, Pneumovax) administered once between month 6 and month 21."
112685|NCT01924169|O1|Outcome|Lenalidomide|"Lenalidomide administered at the dose of 5 mg/day three times a day for three months. If IgG levels improve by at least 25% of baseline, lenalidomide administration continued for 3 months on, and 3 months off for 2 years. If IgG levels do not improve, frequency of lenalidomide increased to 5 mg/day for additional 3 months and if response is achieved, lenalidomide continued at 5mg/day 3 month on/3 month off for a total of 2 years.~Seasonal influenza vaccination (Trivalent Influenza Vaccine, Fluzone High Dose) administered yearly, during the fall/winter season and pneumococcal immunization (Pneumococcal Polysaccharide Vaccine, Pneumovax) administered once between month 6 and month 21."
112686|NCT01924169|E1|Reported Event|Lenalidomide|"Lenalidomide administered at the dose of 5 mg/day three times a day for three months. If IgG levels improve by at least 25% of baseline, lenalidomide administration continued for 3 months on, and 3 months off for 2 years. If IgG levels do not improve, frequency of lenalidomide increased to 5 mg/day for additional 3 months and if response is achieved, lenalidomide continued at 5mg/day 3 month on/3 month off for a total of 2 years.~Seasonal influenza vaccination (Trivalent Influenza Vaccine, Fluzone High Dose) administered yearly, during the fall/winter season and pneumococcal immunization (Pneumococcal Polysaccharide Vaccine, Pneumovax) administered once between month 6 and month 21."
112687|NCT01923896|B3|Baseline|Total|Total of all reporting groups
112688|NCT01923896|B2|Baseline|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
112689|NCT01923896|B1|Baseline|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
112690|NCT01923896|P2|Participant Flow|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
112691|NCT01923896|P1|Participant Flow|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
112692|NCT01923896|O2|Outcome|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
112693|NCT01923896|O1|Outcome|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
112694|NCT01923896|O2|Outcome|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
112695|NCT01923896|O1|Outcome|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
112696|NCT01923896|O2|Outcome|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
112697|NCT01923896|O1|Outcome|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
112698|NCT01923896|O2|Outcome|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
112699|NCT01923896|O1|Outcome|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
112700|NCT01923896|E2|Reported Event|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
112701|NCT01923896|E1|Reported Event|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
112702|NCT01923805|B3|Baseline|Total|Total of all reporting groups
112703|NCT01923805|B2|Baseline|Control|Standard of care for surgical hemostasis.
112704|NCT01923805|B1|Baseline|Treatment Group|"Vitagel~Vitagel: Vitagel"
112705|NCT01923805|P2|Participant Flow|Control|Standard of care for surgical hemostasis.
112706|NCT01923805|P1|Participant Flow|Treatment Group|"Vitagel~Vitagel: Vitagel"
112707|NCT01923805|O2|Outcome|Control|Standard of care for surgical hemostasis.
112708|NCT01923805|O1|Outcome|Treatment Group|"Vitagel~Vitagel: Vitagel"
112709|NCT01923805|E2|Reported Event|Control|Standard of care for surgical hemostasis.
112710|NCT01923805|E1|Reported Event|Treatment Group|"Vitagel~Vitagel: Vitagel"
112711|NCT01923740|B3|Baseline|Total|Total of all reporting groups
112712|NCT01923740|B2|Baseline|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112713|NCT01923740|B1|Baseline|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112734|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112735|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112736|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112737|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112738|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112739|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112740|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112741|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112742|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112743|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112744|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112745|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112746|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112747|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112748|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112749|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112750|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112751|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112752|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112753|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112754|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112755|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112756|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112757|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112758|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112759|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112760|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112761|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112762|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112763|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112764|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112765|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112766|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112767|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112768|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112769|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112770|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112771|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112772|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112773|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112774|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112775|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112776|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112777|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112778|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112779|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112780|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112781|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112782|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112783|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112784|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112785|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112786|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112787|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112788|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112789|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112790|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112791|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112792|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112793|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112794|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112795|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112796|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112797|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112798|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
130315|NCT01836458|O3|Outcome|Dose 3: 10 mg|Single dose of KAE609 10 mg
112799|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112800|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112801|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112802|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112803|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112804|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112805|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112806|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112807|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112808|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112809|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112810|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112811|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112812|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112813|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112814|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112815|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112816|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112817|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112818|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112819|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112820|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112821|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112822|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112823|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112824|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112825|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112826|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112827|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112828|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112829|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112830|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112831|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112832|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112833|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112834|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112835|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112836|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112837|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112838|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112839|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112840|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112841|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112842|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112843|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112844|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112845|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112846|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112847|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112848|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112849|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112850|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112851|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112852|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112853|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112854|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112855|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112856|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112857|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112858|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112859|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112860|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112861|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112862|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112863|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
130316|NCT01836458|O2|Outcome|Dose 2: 20 mg|Single dose of KAE609 20 mg
112864|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112865|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112866|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112867|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112868|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112869|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112870|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112871|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112872|NCT01923740|O2|Outcome|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112873|NCT01923740|O1|Outcome|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112874|NCT01923740|E2|Reported Event|XIENCE V EECSS|XIENCE V EECSS: Subjects receiving XIENCE V
112875|NCT01923740|E1|Reported Event|Absorb BVS System|Absorb BVS System: Subjects receiving Absorb BVS System
112876|NCT01923480|B4|Baseline|Total|Total of all reporting groups
112877|NCT01923480|B3|Baseline|15% CLINISOL 0.13 g/kg/hr|"15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.~15% CLINISOL - Sulfite-free (Amino Acid) Injection"
112878|NCT01923480|B2|Baseline|15% CLINISOL 0.08 g/kg/hr|"15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.~15% CLINISOL - Sulfite-free (Amino Acid) Injection"
112879|NCT01923480|B1|Baseline|15% CLINISOL 0.04 g/kg/hr|"15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.~15% CLINISOL - Sulfite-free (Amino Acid) Injection"
112880|NCT01923480|P6|Participant Flow|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112881|NCT01923480|P5|Participant Flow|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112882|NCT01923480|P4|Participant Flow|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112883|NCT01923480|P3|Participant Flow|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112884|NCT01923480|P2|Participant Flow|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112885|NCT01923480|P1|Participant Flow|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with insulin~15% CLINISOL- Sulfite-Free (Amino Acid) Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112886|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112887|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112888|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112889|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112890|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112891|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112892|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113056|NCT01923389|O2|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
112893|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112894|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112895|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112896|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112897|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112898|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112899|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112900|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112901|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112902|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112903|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112904|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112905|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112906|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112907|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112908|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112909|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112910|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112911|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112912|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113057|NCT01923389|O1|Outcome|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
112913|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112914|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112915|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112916|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112917|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112918|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112919|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112920|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112921|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112922|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112923|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112924|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112925|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112926|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112927|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112928|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112929|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112930|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112931|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112932|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113058|NCT01923389|O2|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
112933|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112934|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112935|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112936|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112937|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112938|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112939|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112940|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112941|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112942|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112943|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112944|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112945|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112946|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112947|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112948|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112949|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112950|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112951|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112952|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113059|NCT01923389|O1|Outcome|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
112953|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112954|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112955|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112956|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112957|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112958|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112959|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112960|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112961|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112962|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112963|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112964|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112965|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112966|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112967|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112968|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112969|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112970|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112971|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112972|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113060|NCT01923389|O2|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
112973|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112974|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112975|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112976|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112977|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112978|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112979|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112980|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112981|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112982|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112983|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112984|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112985|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112986|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112987|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112988|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112989|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112990|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112991|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112992|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113061|NCT01923389|O1|Outcome|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
112993|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112994|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112995|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112996|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112997|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112998|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
112999|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113000|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113001|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113002|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113003|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113004|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113005|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113006|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113007|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113008|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113009|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113010|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113011|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113012|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113062|NCT01923389|O2|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
113013|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113014|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113015|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113016|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113017|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113018|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113019|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113020|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113021|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113022|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113023|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113024|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113025|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113026|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113027|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113028|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113029|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113030|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113031|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113032|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)"
113063|NCT01923389|O1|Outcome|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
113033|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113034|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113035|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
113036|NCT01923480|E3|Reported Event|15% CLINISOL 0.13 g/kg/hr|"15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.~15% CLINISOL - Sulfite-free (Amino Acid) Injection"
113037|NCT01923480|E2|Reported Event|15% CLINISOL 0.08 g/kg/hr|"15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.~15% CLINISOL - Sulfite-free (Amino Acid) Injection"
113038|NCT01923480|E1|Reported Event|15% CLINISOL 0.04 g/kg/hr|"15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.~15% CLINISOL - Sulfite-free (Amino Acid) Injection"
113039|NCT01923467|B1|Baseline|Project Quit Plus NRT Patches|"All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.~Project Quit stop smoking program: This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.~Nicotine patches 21 mg: Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt."
113040|NCT01923467|P1|Participant Flow|Project Quit Plus NRT Patches|"All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.~Project Quit stop smoking program: This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.~Nicotine patches 21 mg: Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt."
113041|NCT01923467|O1|Outcome|Project Quit Plus NRT Patches|"All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.~Project Quit stop smoking program: This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.~Nicotine patches 21 mg: Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt."
113042|NCT01923467|E1|Reported Event|Project Quit Plus NRT Patches|"All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.~Project Quit stop smoking program: This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.~Nicotine patches 21 mg: Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt."
113043|NCT01923389|B3|Baseline|Total|Total of all reporting groups
113044|NCT01923389|B2|Baseline|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
113045|NCT01923389|B1|Baseline|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
113046|NCT01923389|P2|Participant Flow|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
113047|NCT01923389|P1|Participant Flow|Placebo|Placebo (normal saline) was administered as a 20-milliliters (mL) intravenous (IV) infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
113048|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
113049|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
113050|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
113051|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
113052|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
113053|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
113054|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
113055|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
113064|NCT01923389|O2|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
113065|NCT01923389|O1|Outcome|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
113066|NCT01923389|E2|Reported Event|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
113067|NCT01923389|E1|Reported Event|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
113068|NCT01922986|B3|Baseline|Total|Total of all reporting groups
113069|NCT01922986|B2|Baseline|Sham rTMS With Conventional Therapy|"20 minutes of sham rTMS stimulation followed by conventional stroke therapy~sham rTMS: 20 minutes of sham rTMS stimulation~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
113070|NCT01922986|B1|Baseline|Active rTMS With Conventional Therapy|"20 minutes of active rTMS followed by conventional stroke therapy~active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
113071|NCT01922986|P2|Participant Flow|Sham rTMS With Conventional Therapy|"20 minutes of sham rTMS stimulation followed by conventional stroke therapy~sham rTMS: 20 minutes of sham rTMS stimulation~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
113072|NCT01922986|P1|Participant Flow|Active rTMS With Conventional Therapy|"20 minutes of active rTMS followed by conventional stroke therapy~active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
113073|NCT01922986|O2|Outcome|Sham rTMS With Conventional Therapy|"20 minutes of sham rTMS stimulation followed by conventional stroke therapy~sham rTMS: 20 minutes of sham rTMS stimulation~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
113074|NCT01922986|O1|Outcome|Active rTMS With Conventional Therapy|"20 minutes of active rTMS followed by conventional stroke therapy~active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
113075|NCT01922986|O2|Outcome|Sham rTMS With Conventional Therapy|"20 minutes of sham rTMS stimulation followed by conventional stroke therapy~sham rTMS: 20 minutes of sham rTMS stimulation~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
113076|NCT01922986|O1|Outcome|Active rTMS With Conventional Therapy|"20 minutes of active rTMS followed by conventional stroke therapy~active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
113077|NCT01922986|O2|Outcome|Sham rTMS With Conventional Therapy|"20 minutes of sham rTMS stimulation followed by conventional stroke therapy~sham rTMS: 20 minutes of sham rTMS stimulation~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
113078|NCT01922986|O1|Outcome|Active rTMS With Conventional Therapy|"20 minutes of active rTMS followed by conventional stroke therapy~active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
113079|NCT01922986|E2|Reported Event|Sham rTMS With Conventional Therapy|"20 minutes of sham rTMS stimulation followed by conventional stroke therapy~sham rTMS: 20 minutes of sham rTMS stimulation~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
113080|NCT01922986|E1|Reported Event|Active rTMS With Conventional Therapy|"20 minutes of active rTMS followed by conventional stroke therapy~active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
113081|NCT01922934|B3|Baseline|Total|Total of all reporting groups
113082|NCT01922934|B2|Baseline|Registry-Based Control Group|Eligible subjects from an obesity registry (i.e. BMI >/= 30 and at least one weight-related comorbidity) who had at least one measured weight during usual care during the 12-month study period.
113083|NCT01922934|B1|Baseline|Intervention Group|Subjects who were offered the toolbox of weight loss interventions and paid at least one co-pay to start using a tool.
113084|NCT01922934|P2|Participant Flow|Control|"4302 Registry patients not selected to be offered the toolbox options will receive usual care for weight management. Usual care for obesity at DH includes brief weight loss advice provided by PCPs or prescribing of weight loss medication, for which patients pay out of pocket."
113085|NCT01922934|P1|Participant Flow|Intervention|"428 randomly-selected patients from four Denver Health clinics are identified for the intervention arm which offers a toolbox of weight loss options. The toolbox includes: self-monitoring tools; education materials; recreation center passes; commercial weight loss program vouchers (Weight Watchers); intensive group counseling (Colorado Weigh); meal replacements (shakes & entrees); and obesity pharmacotherapy (Qsymia & phentermine). At the initial assessment (visit 0), a computer program helps patients choose a personal treatment mode and they receive a starter kit with self-monitoring tools and meal replacements. Subjects must show self-monitoring of diet and exercise to receive more intensive therapies at their next visit (visit 1). At subsequent monthly visits, patients select a primary intensive therapy, but are able to add/change tools throughout the one year study period. Patients pay a $5-$10 co-pay for the therapies."
113086|NCT01922934|O2|Outcome|Registry-Based Control Group|Eligible subjects from an obesity registry (i.e. BMI >/= 30 and at least one weight-related comorbidity) who had at least one measured weight during usual care during the 12-month study period.
113087|NCT01922934|O1|Outcome|Intervention Group|Subjects who were offered the toolbox of weight loss interventions and paid at least one co-pay to start using a tool.
113150|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
113088|NCT01922934|O1|Outcome|Random Sample of DHHA Registry Control Group|"We selected a random sample of 120 patients from the DHHA registry Control Group for a chart review. The dates used matched the study intervention period. Six reviewers, 3 MDs and 3 study personnel, reviewed medical records for the following:~Presence of ICD-9 code for obesity~Evidence that the the PCP discussed weight loss with the patient~Evidence of a specific intervention for weight management. Each record was evaluated by two reviewers, 1 MD and 1 study personnel ."
113089|NCT01922934|O2|Outcome|Registry-Based Control Group|Eligible subjects from an obesity registry (i.e. BMI >/= 30 and at least one weight-related comorbidity) who had at least one measured weight during usual care during the 12-month study period.
113090|NCT01922934|O1|Outcome|Intervention Group|Subjects who were offered the toolbox of weight loss interventions and paid at least one co-pay to start using a tool.
113091|NCT01922934|O2|Outcome|Registry-Based Control Group|Eligible subjects from an obesity registry (i.e. BMI >/= 30 and at least one weight-related comorbidity) who had at least one measured weight during usual care during the 12-month study period. Included in analysis if they had both baseline and 12 month weights available.
113092|NCT01922934|O1|Outcome|Intervention Group|Subjects who were offered the toolbox of weight loss interventions and paid at least one co-pay to start using a tool. Included in analysis if they had both baseline and 12 month weights available.
113093|NCT01922934|E1|Reported Event|Intervention|"428 randomly-selected patients from four Denver Health clinics were selected to be offered a toolbox of weight loss options, including: self-monitoring tools; education materials; recreation center passes; commercial weight loss program vouchers (Weight Watchers); intensive group counseling (Colorado Weigh); meal replacements (shakes & entrees); and obesity pharmacotherapy (Qsymia & phentermine) for a $5-$10 co-pay for the therapies. Of these 428 patients, 140 came in and consented at the computer program visit at which these options were offered. 119 of these patients came in for a visit one where they received their tool for the first time. Adverse events from the group of 140 patients who consented to receive the intervention are reported."
113094|NCT01922739|B3|Baseline|Total|Total of all reporting groups
113095|NCT01922739|B2|Baseline|Hydrocodone ER - Opioid Experienced|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-experienced participants were defined as those who were taking 10 mg or more per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
113096|NCT01922739|B1|Baseline|Hydrocodone ER - Opioid Naive|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-naïve participants were defined as those who were taking tramadol or less than 10 mg per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
113097|NCT01922739|P1|Participant Flow|Hydrocodone ER|Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both versions of protocol 3104 followed the titration/adjustment period with a open-label treatment period of 22 weeks.
113098|NCT01922739|O1|Outcome|Hydrocodone ER|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both were followed by an open-label treatment period of 22 weeks.
113099|NCT01922739|O3|Outcome|Hydrocodone ER|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both were followed by an open-label treatment period of 22 weeks.
113100|NCT01922739|O2|Outcome|Hydrocodone ER - Opioid Experienced|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-experienced participants were defined as those who were taking 10 mg or more per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
113101|NCT01922739|O1|Outcome|Hydrocodone ER - Opioid Naive|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-naïve participants were defined as those who were taking tramadol or less than 10 mg per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
113102|NCT01922739|O3|Outcome|Hydrocodone ER|Participants were administered extended-release hydrocodone tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both were followed by an open label treatment period of 22 weeks.
113103|NCT01922739|O2|Outcome|Hydrocodone ER - Opioid Experienced|Participants were administered extended-release hydrocodone tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-experienced participants were defined as those who were taking 10 mg or more per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
113151|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
113189|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
113104|NCT01922739|O1|Outcome|Hydrocodone ER - Opioid Naive|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-naïve participants were defined as those who were taking tramadol or less than 10 mg per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
113105|NCT01922739|O3|Outcome|Hydrocodone ER|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both were followed by an open-label treatment period of 22 weeks.
113106|NCT01922739|O2|Outcome|Hydrocodone ER - Opioid Experienced|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-experienced participants were defined as those who were taking 10 mg or more per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
113107|NCT01922739|O1|Outcome|Hydrocodone ER - Opioid Naive|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-naïve participants were defined as those who were taking tramadol or less than 10 mg per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
113108|NCT01922739|O3|Outcome|Hydrocodone ER|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both were followed by an open-label treatment period of 22 weeks.
113109|NCT01922739|O2|Outcome|Hydrocodone ER - Opioid Experienced|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-experienced participants were defined as those who were taking 10 mg or more per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
113110|NCT01922739|O1|Outcome|Hydrocodone ER - Opioid Naive|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-naïve participants were defined as those who were taking tramadol or less than 10 mg per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
113111|NCT01922739|O1|Outcome|Hydrocodone ER|Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both versions of protocol 3104 followed the titration/adjustment period with a open-label treatment period of 22 weeks.
113112|NCT01922739|O1|Outcome|Hydrocodone ER|Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both versions of protocol 3104 followed the titration/adjustment period with a open-label treatment period of 22 weeks.
113113|NCT01922739|O1|Outcome|Hydrocodone ER|Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both versions of protocol 3104 followed the titration/adjustment period with a open-label treatment period of 22 weeks.
113114|NCT01922739|O5|Outcome|Hydrocodone ER: Open-Label Treatment Period|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful during the Titration/Adjustment period for managing their pain. The Open-Label Treatment Period lasted 22 weeks.
113115|NCT01922739|O4|Outcome|Hydrocodone ER: Open-Label Adjustment Period|"Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.~As defined in the amended protocol, participants who received hydrocodone ER during the double-blind treatment period in Study 3103 took hydrocodone ER every 12 hours titrated to an effective dosage over approximately 3 weeks."
113116|NCT01922739|O3|Outcome|Placebo: Open-Label Adjustment Period|"Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.~As defined in the amended protocol, participants who received placebo during the double-blind treatment period in Study 3103 took hydrocodone ER every 12 hours titrated to an effective dosage over approximately 3 weeks."
113117|NCT01922739|O2|Outcome|Hydrocodone ER: Double-Blind Titration Period|"Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.~As defined in the original protocol, participants who received hydrocodone ER during the double-blind treatment period in Study 3103 took hydrocodone ER tablets and matching placebo every 12 hours titrated to an effective dosage over approximately 4 weeks."
113152|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
113190|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
113118|NCT01922739|O1|Outcome|Placebo: Double-Blind Titration Period|"Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.~As defined in the original protocol, participants who received placebo during the double-blind treatment period in Study 3103 took hydrocodone bitartrate ER tablets (and matching placebo) every 12 hours titrated to an effective dosage over approximately 4 weeks."
113119|NCT01922739|E2|Reported Event|Hydrocodone ER - Open-Label Treatment Period|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful during the Titration/Adjustment period for managing their pain. The Treatment Period lasted 22 weeks.
113120|NCT01922739|E1|Reported Event|Hydrocodone ER - Titration/Adjustment Period|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. The titration/adjustment period lasted 3-4 weeks.
113121|NCT01922349|B5|Baseline|Total|Total of all reporting groups
113122|NCT01922349|B4|Baseline|BI 113608 - 50 mg|2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
113123|NCT01922349|B3|Baseline|BI 113608 - 25 mg|1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
113124|NCT01922349|B2|Baseline|BI 113608 - 10 mg|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
113125|NCT01922349|B1|Baseline|Placebo|Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
113126|NCT01922349|P4|Participant Flow|BI 113608 - 50 mg|2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
113127|NCT01922349|P3|Participant Flow|BI 113608 - 25 mg|1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
113128|NCT01922349|P2|Participant Flow|BI 113608 - 10 mg|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
113129|NCT01922349|P1|Participant Flow|Placebo|Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (Multiple rising dose (MRD) period)
113130|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
113131|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
113132|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
113133|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
113134|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
113135|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
113136|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
113137|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
113138|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
113139|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
113140|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
113141|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
113142|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
113143|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
113144|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
113145|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
113146|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
113147|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
113148|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
113149|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
113153|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
113154|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
113155|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
113156|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
113157|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
113158|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
113159|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
113160|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
113161|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
113162|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
113163|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
113164|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
113165|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
113166|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
113167|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
113168|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
113169|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 days in Chinese subjects (MRD period)
113170|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
113171|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
113172|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
113173|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
113174|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
113175|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
113176|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
113177|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
113178|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
113179|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
113180|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
113181|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
113182|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
113183|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
113184|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
113185|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
113186|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
113187|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
113188|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
130317|NCT01836458|O1|Outcome|Dose 1: 30 mg|Single dose of KAE609 30 mg
113191|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
113192|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
113193|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
113194|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
113195|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
113196|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
113197|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
113198|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
113199|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
113200|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
113201|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
113202|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
113203|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
113204|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
113205|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
113206|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
113207|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
113208|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
113209|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
113210|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
113211|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
113212|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
113213|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
113214|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
113215|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
113216|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
113217|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
113218|NCT01922349|O4|Outcome|BI 113608 - 50 mg|2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
113219|NCT01922349|O3|Outcome|BI 113608 - 25 mg|1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
113220|NCT01922349|O2|Outcome|BI 113608 - 10 mg|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
113221|NCT01922349|O1|Outcome|Placebo|Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
113222|NCT01922349|E11|Reported Event|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Caucasian subjects
113223|NCT01922349|E10|Reported Event|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Japanese subjects
113224|NCT01922349|E9|Reported Event|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Chinese subjects
113225|NCT01922349|E8|Reported Event|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Japanese subjects
113226|NCT01922349|E7|Reported Event|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Chinese subjects
113227|NCT01922349|E6|Reported Event|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Caucasian subjects
113228|NCT01922349|E5|Reported Event|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Japanese subjects
113229|NCT01922349|E4|Reported Event|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 days (MRD period) in Chinese subjects
113230|NCT01922349|E3|Reported Event|Placebo- Caucasian|Matching placebo tablet: oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Caucasian subjects
113231|NCT01922349|E2|Reported Event|Placebo- Japanese|Matching placebo tablet: oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Japanese subjects
113232|NCT01922349|E1|Reported Event|Placebo- Chinese|Matching placebo tablet: oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Chinese subjects
113233|NCT01922271|B3|Baseline|Total|Total of all reporting groups
113234|NCT01922271|B2|Baseline|Tiotropium Followed by NVA237|Period 1: tiotropium plus placebo to NVA237 on day 1, followed by a 7 day washout. Period 2: NVA237 plus placebo to tiotropium on day 8. Salbutamol was used as rescue medication.
113235|NCT01922271|B1|Baseline|NVA237 Followed by Tiotropium|Period 1: NVA237 plus placebo to tiotropium on day 1, followed by a 7 day washout. Period 2: tiotropium plus placebo to NVA237 on day 8. Salbutamol was used as rescue medication.
113236|NCT01922271|P2|Participant Flow|Tiotropium Followed by NVA237|Period 1: tiotropium plus placebo to NVA237 on day 1, followed by a 7 day washout. Period 2: NVA237 plus placebo to tiotropium on day 8. Salbutamol was used as rescue medication.
113237|NCT01922271|P1|Participant Flow|NVA237 Followed by Tiotropium|Period 1: NVA237 plus placebo to tiotropium on day 1, followed by a 7 day washout. Period 2: tiotropium plus placebo to NVA237 on day 8. Salbutamol was used as rescue medication.
113238|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
113239|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
113240|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
113241|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
113242|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
113243|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
113244|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
113245|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
113246|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
113247|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
113248|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
113249|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
113250|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
113251|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
113252|NCT01922271|E2|Reported Event|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
113253|NCT01922271|E1|Reported Event|NVA237|ALL patients on NVA237 for Period 1 & Period 2
113254|NCT01922219|B1|Baseline|Cognitive Behavioral Therapy|"Depressed individuals who enroll in this study will receive 14 sessions of cognitive behavioral therapy provided by an experienced psychiatrist or psychologist over 12 weeks (twice-a-week for the first two weeks, and weekly after that).~Cognitive Behavioral Therapy: 14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks"
113255|NCT01922219|P1|Participant Flow|Cognitive Behavioral Therapy|"Depressed individuals who enroll in this study will receive 14 sessions of cognitive behavioral therapy provided by an experienced psychiatrist or psychologist over 12 weeks (twice-a-week for the first two weeks, and weekly after that).~Cognitive Behavioral Therapy: 14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks"
113256|NCT01922219|O1|Outcome|Cognitive Behavioral Therapy|"Depressed individuals who enroll in this study will receive 14 sessions of cognitive behavioral therapy provided by an experienced psychiatrist or psychologist over 12 weeks (twice-a-week for the first two weeks, and weekly after that).~Cognitive Behavioral Therapy: 14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks"
113257|NCT01922219|O1|Outcome|Cognitive Behavioral Therapy|"Depressed individuals who enroll in this study will receive 14 sessions of cognitive behavioral therapy provided by an experienced psychiatrist or psychologist over 12 weeks (twice-a-week for the first two weeks, and weekly after that).~Cognitive Behavioral Therapy: 14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks"
113258|NCT01922219|O1|Outcome|Cognitive Behavioral Therapy|"Depressed individuals who enroll in this study will receive 14 sessions of cognitive behavioral therapy provided by an experienced psychiatrist or psychologist over 12 weeks (twice-a-week for the first two weeks, and weekly after that).~Cognitive Behavioral Therapy: 14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks"
113259|NCT01922219|E1|Reported Event|Cognitive Behavioral Therapy|"Depressed individuals who enroll in this study will receive 14 sessions of cognitive behavioral therapy provided by an experienced psychiatrist or psychologist over 12 weeks (twice-a-week for the first two weeks, and weekly after that).~Cognitive Behavioral Therapy: 14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks"
113260|NCT01922115|B3|Baseline|Total|Total of all reporting groups
113261|NCT01922115|B2|Baseline|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).~Placebo"
113262|NCT01922115|B1|Baseline|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).~Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
113263|NCT01922115|P2|Participant Flow|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).~Placebo"
113296|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113264|NCT01922115|P1|Participant Flow|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).~Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
113265|NCT01922115|O2|Outcome|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).~Placebo"
113266|NCT01922115|O1|Outcome|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).~Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
113267|NCT01922115|O2|Outcome|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).~Placebo"
113268|NCT01922115|O1|Outcome|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).~Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
113269|NCT01922115|O2|Outcome|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).~Placebo"
113270|NCT01922115|O1|Outcome|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).~Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
113271|NCT01922115|O2|Outcome|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).~Placebo"
113272|NCT01922115|O1|Outcome|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).~Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
113273|NCT01922115|E2|Reported Event|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).~Placebo"
113274|NCT01922115|E1|Reported Event|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).~Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
113275|NCT01922089|B3|Baseline|Total|Total of all reporting groups
113276|NCT01922089|B2|Baseline|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
113277|NCT01922089|B1|Baseline|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
113278|NCT01922089|P2|Participant Flow|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
113279|NCT01922089|P1|Participant Flow|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
113280|NCT01922089|O2|Outcome|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
113281|NCT01922089|O1|Outcome|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
113282|NCT01922089|O2|Outcome|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
113283|NCT01922089|O1|Outcome|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
113284|NCT01922089|O2|Outcome|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
113285|NCT01922089|O1|Outcome|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
113286|NCT01922089|E2|Reported Event|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
113287|NCT01922089|E1|Reported Event|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
113288|NCT01922037|B3|Baseline|Total|Total of all reporting groups
113289|NCT01922037|B2|Baseline|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113290|NCT01922037|B1|Baseline|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113291|NCT01922037|P2|Participant Flow|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age greater than or equal to [>/=18] years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113292|NCT01922037|P1|Participant Flow|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113293|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113294|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113295|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
133855|NCT01818414|B3|Baseline|Total|Total of all reporting groups
113297|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113298|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113299|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113300|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113301|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113302|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113303|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113304|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113305|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113306|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113307|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113308|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113309|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113310|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113311|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113312|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113313|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113314|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113315|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113316|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113317|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113318|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113823|NCT01920802|O3|Outcome|Placebo|"BID placebo up to 4 weeks~Placebo: BID up to 4 weeks"
113319|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113320|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113321|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113322|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113323|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113324|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113325|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113326|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113327|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113328|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113329|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113330|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113331|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113332|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113333|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113334|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113335|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113336|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113337|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113338|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113339|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113340|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
114143|NCT01919216|O3|Outcome|Placebo Track - Placebo|Binded treatment with placebo
113341|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113342|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113343|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113344|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113345|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113346|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113347|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113348|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113349|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113350|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113351|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113352|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113353|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113354|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113355|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113356|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113357|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113358|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113359|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113360|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113361|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113362|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113387|NCT01922011|P1|Participant Flow|Daptomycin|Intravenous (IV) daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily
113363|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113364|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113365|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113366|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113367|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113368|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113369|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113370|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113371|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113372|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113373|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113374|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113375|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113376|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113377|NCT01922037|O3|Outcome|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113378|NCT01922037|O2|Outcome|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113379|NCT01922037|O1|Outcome|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113380|NCT01922037|E3|Reported Event|Total Participants With Allergic Asthma|All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113381|NCT01922037|E2|Reported Event|Participants With Allergic Asthma (Age >/=18 Years)|Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113382|NCT01922037|E1|Reported Event|Participants With Allergic Asthma (Age 12-17 Years)|Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
113383|NCT01922011|B3|Baseline|Total|Total of all reporting groups
113384|NCT01922011|B2|Baseline|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h.
113385|NCT01922011|B1|Baseline|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily
113386|NCT01922011|P2|Participant Flow|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg every six hours (q6h), or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h.
119472|NCT01890694|O1|Outcome|Tolvaptan|Subjects will receive Tolvaptan once daily.
113388|NCT01922011|O4|Outcome|Daptomycin 12 - < 18 Yrs Old|IV daptomycin 7 mg/kg once daily and ≤3 dummy infusions daily for ages 12 - < 18 yrs old only.
113389|NCT01922011|O3|Outcome|Daptomycin 7 - < 12 Yrs Old|IV daptomycin 9 mg/kg once daily and ≤3 dummy infusions daily for ages 7 - < 12 yrs old only.
113390|NCT01922011|O2|Outcome|Daptomycin 24 Months - < 7 Yrs Old|IV daptomycin 12 mg/kg once daily and ≤3 dummy infusions daily for ages 24 months - < 7 yrs old only.
113391|NCT01922011|O1|Outcome|Daptomycin 12 - < 24 Months Old|IV daptomycin 12 mg/kg once daily and ≤3 dummy infusions daily for ages 12 - < 24 months old only.
113392|NCT01922011|O4|Outcome|Daptomycin 12 - < 18 Yrs Old|IV daptomycin 7 mg/kg once daily and ≤3 dummy infusions daily for ages 12 - < 18 yrs old only.
113393|NCT01922011|O3|Outcome|Daptomycin 7 - < 12 Yrs Old|IV daptomycin 9, mg/kg once daily and ≤3 dummy infusions daily for ages 7 - < 12 yrs old only.
113394|NCT01922011|O2|Outcome|Daptomycin 24 Months - < 7 Yrs Old|IV daptomycin 12 mg/kg once daily and ≤3 dummy infusions daily for ages 24 months - < 7 yrs old only.
113395|NCT01922011|O1|Outcome|Daptomycin 12 - < 24 Months Old|IV daptomycin 12 mg/kg once daily and ≤3 dummy infusions daily for ages 12 - < 24 months old only.
113396|NCT01922011|O4|Outcome|Daptomycin 12 - < 18 Yrs Old|IV daptomycin 7 mg/kg once daily and ≤3 dummy infusions daily for ages 12 - < 18 yrs old only.
113397|NCT01922011|O3|Outcome|Daptomycin 7 - < 12 Yrs Old|IV daptomycin 9 mg/kg once daily and ≤3 dummy infusions daily for ages 7 - < 12 yrs old only.
113398|NCT01922011|O2|Outcome|Daptomycin 24 Months - < 7 Yrs Old|IV daptomycin 12 mg/kg once daily and ≤3 dummy infusions daily for ages 24 months - < 7 yrs old only.
113399|NCT01922011|O1|Outcome|Daptomycin 12 - < 24 Months Old|IV daptomycin 12 mg/kg once daily and ≤3 dummy infusions daily for ages 12 - < 24 months old only.
113400|NCT01922011|O4|Outcome|Daptomycin 12 - < 18 Yrs Old|IV daptomycin 7 mg/kg once daily and ≤3 dummy infusions daily for ages 12 - < 18 yrs old only.
113401|NCT01922011|O3|Outcome|Daptomycin 7 - < 12 Yrs Old|IV daptomycin 9 mg/kg once daily and ≤3 dummy infusions daily for ages 7 - < 12 yrs old only.
113402|NCT01922011|O2|Outcome|Daptomycin 24 Months - < 7 Yrs Old|IV daptomycin 12 mg/kg once daily and ≤3 dummy infusions daily for ages 24 months - < 7 yrs old only.
113403|NCT01922011|O1|Outcome|Daptomycin 12 - < 24 Months Old|IV daptomycin 12 mg/kg once daily and ≤3 dummy infusions daily for ages 12 - < 24 months old only.
113404|NCT01922011|O2|Outcome|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h
113405|NCT01922011|O1|Outcome|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily.
113406|NCT01922011|O2|Outcome|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h
113407|NCT01922011|O1|Outcome|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily.
113408|NCT01922011|O2|Outcome|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h
113409|NCT01922011|O1|Outcome|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily.
113410|NCT01922011|O2|Outcome|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h
113411|NCT01922011|O1|Outcome|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily.
113412|NCT01922011|O2|Outcome|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h
113413|NCT01922011|O1|Outcome|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily.
113414|NCT01922011|O2|Outcome|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h
113415|NCT01922011|O1|Outcome|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily.
113416|NCT01922011|O2|Outcome|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h
113417|NCT01922011|O1|Outcome|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily.
113418|NCT01922011|O2|Outcome|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h
113419|NCT01922011|O1|Outcome|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily.
113420|NCT01922011|O2|Outcome|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h
113421|NCT01922011|O1|Outcome|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily
113422|NCT01922011|O2|Outcome|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h
113423|NCT01922011|O1|Outcome|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily
113424|NCT01922011|E2|Reported Event|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h.
113425|NCT01922011|E1|Reported Event|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily
113426|NCT01921894|B4|Baseline|Total|Total of all reporting groups
113427|NCT01921894|B3|Baseline|Cholecalciferol 200 IU|Cholecalciferol 200 IU oral chewable tablet once daily for 8 weeks
113428|NCT01921894|B2|Baseline|Cholecalciferol 2000 IU|Cholecalciferol 2000 IU oral chewable tablet once daily for 8 weeks
113429|NCT01921894|B1|Baseline|Cholecalciferol 4000 IU|Cholecalciferol 4000 IU oral chewable tablet once daily for 8 weeks
113430|NCT01921894|P3|Participant Flow|Cholecalciferol 200 IU|"Cholecalciferol 200 IU oral chewable tablet once daily for 8 weeks~Cholecalciferol: vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day."
113617|NCT01921166|O2|Outcome|Leuprolide Flare|"Leuprolide flare~Leuprolide flare: Leuprolide flare ovulation induction"
119473|NCT01890694|O2|Outcome|Placebo|Study Terminated. No data analyzed
113431|NCT01921894|P2|Participant Flow|Cholecalciferol 2000 IU|"Cholecalciferol 2000 IU oral chewable tablet once daily for 8 weeks~Cholecalciferol: vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day."
113432|NCT01921894|P1|Participant Flow|Cholecalciferol 4000 IU|"Cholecalciferol 4000 IU oral chewable tablet once daily for 8 weeks~Cholecalciferol: vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day."
113433|NCT01921894|O3|Outcome|Cholecalciferol 200 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 4 weeks.
113434|NCT01921894|O2|Outcome|Cholecalciferol 2000 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 4 weeks.
113435|NCT01921894|O1|Outcome|Cholecalciferol 4000 IU|All participants randomized to 4000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 4 weeks.
113436|NCT01921894|O3|Outcome|Cholecalciferol 200 IU|All participants randomized to 200 IU per day were analyzed. Outcome was defined having FEV1 < 80% of predicted
113437|NCT01921894|O2|Outcome|Cholecalciferol 2000 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined having FEV1 < 80% of predicted
113438|NCT01921894|O1|Outcome|Cholecalciferol 4000 IU|All participants randomized to 4000 IU per day were analyzed. Outcome was defined having FEV1 < 80% of predicted
113439|NCT01921894|O3|Outcome|Cholecalciferol 200 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having urinary calcium/creatinine ratio > 0.37
113440|NCT01921894|O2|Outcome|Cholecalciferol 2000 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having urinary calcium/creatinine ratio > 0.37
113441|NCT01921894|O1|Outcome|Cholecalciferol 4000 IU|All participants randomized to 4000 IU per day were analyzed. Outcome was defined as having urinary calcium/creatinine ratio > 0.37
113442|NCT01921894|O3|Outcome|Cholecalciferol 200 IU|All participants randomized to 200 IU per day were analyzed. Outcome was defined as having vitamin D toxicity, hypercalcemia (>10.8 mg/dl) or elevated uCa/uCr (>0.37).
113443|NCT01921894|O2|Outcome|Cholecalciferol 2000 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having vitamin D toxicity, hypercalcemia (>10.8 mg/dl) or elevated uCa/uCr (>0.37).
113444|NCT01921894|O1|Outcome|Cholecalciferol 4000 IU|All participants randomized to 4000 IU per day were analyzed. Outcome was defined as having vitamin D toxicity, hypercalcemia (>10.8 mg/dl) or elevated uCa/uCr (>0.37).
113445|NCT01921894|O3|Outcome|Cholecalciferol 200 IU|All participants randomized to 200 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
113446|NCT01921894|O2|Outcome|Cholecalciferol 2000 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
113447|NCT01921894|O1|Outcome|Cholecalciferol 4000 IU|All participants randomized to 4000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
113448|NCT01921894|E3|Reported Event|Cholecalciferol 200 IU|All participants randomized to 200 IU per day were analyzed. Outcome includes any report of adverse events.
113449|NCT01921894|E2|Reported Event|Cholecalciferol 2000 IU|All participants randomized to 2000 IU per day were analyzed. Outcome includes any report of adverse events.
113450|NCT01921894|E1|Reported Event|Cholecalciferol 4000 IU|All participants randomized to 4000 IU per day were analyzed. Outcome includes any report of adverse events.
113451|NCT01921829|B3|Baseline|Total|Total of all reporting groups
113452|NCT01921829|B2|Baseline|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
113453|NCT01921829|B1|Baseline|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
113454|NCT01921829|P2|Participant Flow|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
113455|NCT01921829|P1|Participant Flow|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
113456|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
113457|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
113458|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
113459|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
113460|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
113461|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
113462|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
113463|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
113464|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
113465|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
113466|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
113467|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
113468|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
113469|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
113470|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
113618|NCT01921166|O1|Outcome|Clomiphene Plus Gonadotropins|"clomiphene plus gonadotropins~clomiphene plus gonadotropins: clomiphene plus gonadotropin ovulation induction"
113619|NCT01921166|O2|Outcome|Leuprolide Flare|"Leuprolide flare~Leuprolide flare: Leuprolide flare ovulation induction"
113471|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
113472|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
113473|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
113474|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
113475|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
113476|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
113477|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
113478|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
113479|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
113480|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
113481|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
113482|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
113483|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
113497|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
113620|NCT01921166|O1|Outcome|Clomiphene Plus Gonadotropins|"clomiphene plus gonadotropins~clomiphene plus gonadotropins: clomiphene plus gonadotropin ovulation induction"
119474|NCT01890694|O1|Outcome|Tolvaptan|Subjects will receive Tolvaptan once daily.
113484|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
113485|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
113486|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
113487|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
113488|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
113489|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
113490|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
113491|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
113492|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
113493|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
113494|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
113495|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
113496|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
113597|NCT01921205|O1|Outcome|Placebo (FAS)|This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
113498|NCT01921829|E2|Reported Event|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
113499|NCT01921829|E1|Reported Event|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
113500|NCT01921751|B4|Baseline|Total|Total of all reporting groups
113501|NCT01921751|B3|Baseline|Chemotherapy|Gemcitabine and nab-paclitaxel until progression or unacceptable toxicity [randomized to this arm after 3rd cycle and no progression]
113502|NCT01921751|B2|Baseline|Chemotherapy + Low Intensity Radiation|Induction chemotherapy with four cycles of gemcitabine and nab-paclitaxel [randomized to this arm after 3rd cycle and no progression]; followed by concurrent low intensity radiation therapy and capecitabine; followed by consolidation chemotherapy with gemcitabine and nab-paclitaxel until progression or unacceptable toxicity
113503|NCT01921751|B1|Baseline|Chemotherapy + High Intensity Radiation|Induction chemotherapy with four cycles of gemcitabine and nab-paclitaxel [randomized to this arm after 3rd cycle and no progression]; followed by concurrent high intensity radiation therapy and capecitabine; followed by consolidation chemotherapy with gemcitabine and nab-paclitaxel until progression or unacceptable toxicity
113504|NCT01921751|P3|Participant Flow|Chemotherapy|Gemcitabine and nab-paclitaxel until progression or unacceptable toxicity [randomized to this arm after 3rd cycle and no progression]
113505|NCT01921751|P2|Participant Flow|Chemotherapy + Low Intensity Radiation|Induction chemotherapy with four cycles of gemcitabine and nab-paclitaxel [randomized to this arm after 3rd cycle and no progression]; followed by concurrent low intensity radiation therapy and capecitabine; followed by consolidation chemotherapy with gemcitabine and nab-paclitaxel until progression or unacceptable toxicity
113506|NCT01921751|P1|Participant Flow|Chemotherapy + High Intensity Radiation|Induction chemotherapy with four cycles of gemcitabine and nab-paclitaxel [randomized to this arm after 3rd cycle and no progression]; followed by concurrent high intensity radiation therapy and capecitabine; followed by consolidation chemotherapy with gemcitabine and nab-paclitaxel until progression or unacceptable toxicity
113507|NCT01921751|O3|Outcome|Chemotherapy|Gemcitabine and nab-paclitaxel until progression or unacceptable toxicity [randomized to this arm after 3rd cycle and no progression]
113508|NCT01921751|O2|Outcome|Chemotherapy + Low Intensity Radiation|Induction chemotherapy with four cycles of gemcitabine and nab-paclitaxel [randomized to this arm after 3rd cycle and no progression]; followed by concurrent low intensity radiation therapy and capecitabine; followed by consolidation chemotherapy with gemcitabine and nab-paclitaxel until progression or unacceptable toxicity
113509|NCT01921751|O1|Outcome|Chemotherapy + High Intensity Radiation|Induction chemotherapy with four cycles of gemcitabine and nab-paclitaxel [randomized to this arm after 3rd cycle and no progression]; followed by concurrent high intensity radiation therapy and capecitabine; followed by consolidation chemotherapy with gemcitabine and nab-paclitaxel until progression or unacceptable toxicity
113510|NCT01921751|O3|Outcome|Chemotherapy|Gemcitabine and nab-paclitaxel until progression or unacceptable toxicity [randomized to this arm after 3rd cycle and no progression]
113511|NCT01921751|O2|Outcome|Chemotherapy + Low Intensity Radiation|Induction chemotherapy with four cycles of gemcitabine and nab-paclitaxel [randomized to this arm after 3rd cycle and no progression]; followed by concurrent low intensity radiation therapy and capecitabine; followed by consolidation chemotherapy with gemcitabine and nab-paclitaxel until progression or unacceptable toxicity
113512|NCT01921751|O1|Outcome|Chemotherapy + High Intensity Radiation|Induction chemotherapy with four cycles of gemcitabine and nab-paclitaxel [randomized to this arm after 3rd cycle and no progression]; followed by concurrent high intensity radiation therapy and capecitabine; followed by consolidation chemotherapy with gemcitabine and nab-paclitaxel until progression or unacceptable toxicity
113513|NCT01921751|O3|Outcome|Chemotherapy|Gemcitabine and nab-paclitaxel until progression or unacceptable toxicity [randomized to this arm after 3rd cycle and no progression]
113514|NCT01921751|O2|Outcome|Chemotherapy + Low Intensity Radiation|Induction chemotherapy with four cycles of gemcitabine and nab-paclitaxel [randomized to this arm after 3rd cycle and no progression]; followed by concurrent low intensity radiation therapy and capecitabine; followed by consolidation chemotherapy with gemcitabine and nab-paclitaxel until progression or unacceptable toxicity
113515|NCT01921751|O1|Outcome|Chemotherapy + High Intensity Radiation|Induction chemotherapy with four cycles of gemcitabine and nab-paclitaxel [randomized to this arm after 3rd cycle and no progression]; followed by concurrent high intensity radiation therapy and capecitabine; followed by consolidation chemotherapy with gemcitabine and nab-paclitaxel until progression or unacceptable toxicity
113516|NCT01921751|O3|Outcome|Chemotherapy|Gemcitabine and nab-paclitaxel until progression or unacceptable toxicity [randomized to this arm after 3rd cycle and no progression]
113517|NCT01921751|O2|Outcome|Chemotherapy + Low Intensity Radiation|Induction chemotherapy with four cycles of gemcitabine and nab-paclitaxel [randomized to this arm after 3rd cycle and no progression]; followed by concurrent low intensity radiation therapy and capecitabine; followed by consolidation chemotherapy with gemcitabine and nab-paclitaxel until progression or unacceptable toxicity
113518|NCT01921751|O1|Outcome|Chemotherapy + High Intensity Radiation|Induction chemotherapy with four cycles of gemcitabine and nab-paclitaxel [randomized to this arm after 3rd cycle and no progression]; followed by concurrent high intensity radiation therapy and capecitabine; followed by consolidation chemotherapy with gemcitabine and nab-paclitaxel until progression or unacceptable toxicity
113519|NCT01921751|E4|Reported Event|Chemotherapy - Not Randomized|Induction chemotherapy with three cycles of gemcitabine and nab-paclitaxel [not randomized]
113520|NCT01921751|E3|Reported Event|Chemotherapy|Gemcitabine and nab-paclitaxel until progression or unacceptable toxicity [randomized to this arm after 3rd cycle and no progression]
113521|NCT01921751|E2|Reported Event|Chemotherapy + Low Intensity Radiation|Induction chemotherapy with four cycles of gemcitabine and nab-paclitaxel [randomized to this arm after 3rd cycle and no progression]; followed by concurrent low intensity radiation therapy and capecitabine; followed by consolidation chemotherapy with gemcitabine and nab-paclitaxel until progression or unacceptable toxicity
113522|NCT01921751|E1|Reported Event|Chemotherapy + High Intensity Radiation|Induction chemotherapy with four cycles of gemcitabine and nab-paclitaxel [randomized to this arm after 3rd cycle and no progression]; followed by concurrent high intensity radiation therapy and capecitabine; followed by consolidation chemotherapy with gemcitabine and nab-paclitaxel until progression or unacceptable toxicity
113523|NCT01921452|B1|Baseline|POC TSH Kits + Third Generation TSH Kit|Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant’s fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
113524|NCT01921452|P1|Participant Flow|POC TSH Kits + Third Generation Kit|Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant's fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
113525|NCT01921452|O1|Outcome|POC TSH Kits + Third Generation Kit|Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant’s fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
113526|NCT01921452|O1|Outcome|POC TSH Kits + Third Generation TSH Kit|Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant’s fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
113527|NCT01921452|E1|Reported Event|POC TSH Kit + Third Generation TSH Kit|Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant’s fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
113528|NCT01921348|B3|Baseline|Total|Total of all reporting groups
113529|NCT01921348|B2|Baseline|Sham|"33 participants will be randomized to wear acupressure pellets in non-specific areas of the ear and apply pressure as instructed by the study personnel.~acupressure pellets: The sham group will have acupressure pellets placed in a pre-determined non-specific acupressure point on the ear that is not related to rhinitis."
113530|NCT01921348|B1|Baseline|Treatment|"34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel.~acupressure pellets: The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis."
113531|NCT01921348|P2|Participant Flow|Sham|"33 participants will be randomized to wear acupressure pellets in non-specific areas of the ear and apply pressure as instructed by the study personnel.~acupressure pellets: The sham group will have acupressure pellets placed in a pre-determined non-specific acupressure point on the ear that is not related to rhinitis."
113532|NCT01921348|P1|Participant Flow|Treatment|"34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel.~acupressure pellets: The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis."
113533|NCT01921348|O2|Outcome|Sham|"33 participants will be randomized to wear acupressure pellets in non-specific areas of the ear and apply pressure as instructed by the study personnel.~acupressure pellets: The sham group will have acupressure pellets placed in a pre-determined non-specific acupressure point on the ear that is not related to rhinitis."
113534|NCT01921348|O1|Outcome|Treatment|"34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel.~acupressure pellets: The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis."
113535|NCT01921348|O2|Outcome|Sham|"33 participants will be randomized to wear acupressure pellets in non-specific areas of the ear and apply pressure as instructed by the study personnel.~acupressure pellets: The sham group will have acupressure pellets placed in a pre-determined non-specific acupressure point on the ear that is not related to rhinitis."
113536|NCT01921348|O1|Outcome|Treatment|"34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel.~acupressure pellets: The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis."
113537|NCT01921348|O2|Outcome|Sham|"33 participants will be randomized to wear acupressure pellets in non-specific areas of the ear and apply pressure as instructed by the study personnel.~acupressure pellets: The sham group will have acupressure pellets placed in a pre-determined non-specific acupressure point on the ear that is not related to rhinitis."
113538|NCT01921348|O1|Outcome|Treatment|"34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel.~acupressure pellets: The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis."
113539|NCT01921348|E2|Reported Event|Sham|"33 participants will be randomized to wear acupressure pellets in non-specific areas of the ear and apply pressure as instructed by the study personnel.~acupressure pellets: The sham group will have acupressure pellets placed in a pre-determined non-specific acupressure point on the ear that is not related to rhinitis."
113540|NCT01921348|E1|Reported Event|Treatment|"34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel.~acupressure pellets: The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis."
113541|NCT01921322|B3|Baseline|Total|Total of all reporting groups
113542|NCT01921322|B2|Baseline|Multiple Daily Injections|Multiple daily insulin injections used for treatment
113543|NCT01921322|B1|Baseline|Pump|Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring
113544|NCT01921322|P2|Participant Flow|Multiple Daily Injections|Multiple daily insulin injections used for treatment
113545|NCT01921322|P1|Participant Flow|Pump|Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring
113546|NCT01921322|O2|Outcome|Multiple Daily Injections|Multiple daily insulin injections used for treatment
113547|NCT01921322|O1|Outcome|Pump|Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring
113548|NCT01921322|O2|Outcome|Multiple Daily Injections|Multiple daily insulin injections used for treatment
113549|NCT01921322|O1|Outcome|Pump|Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring
113550|NCT01921322|E2|Reported Event|Multiple Daily Injections|Multiple daily insulin injections used for treatment
113551|NCT01921322|E1|Reported Event|Pump|Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring
113552|NCT01921296|B1|Baseline|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
113553|NCT01921296|P1|Participant Flow|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
113554|NCT01921296|O1|Outcome|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
113555|NCT01921296|O1|Outcome|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
113556|NCT01921296|O1|Outcome|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
113557|NCT01921296|O1|Outcome|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
113558|NCT01921296|O1|Outcome|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
113559|NCT01921296|E1|Reported Event|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
113560|NCT01921270|B1|Baseline|Dysport Injections|"Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.~Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections.~Location of injections will be determined by the clinician to treat the individual's dystonic symptom.~Muscles that may be included for in injection for OMD with Jaw Closing:~Medial Pterygoid 50 units, Masseter 25 units~Muscles that may be included in injection for OMD with Jaw Opening:~Lateral Pterygoid 50 units, Anterior digastrics 10 units~Muscle that will be included in injection for OMD with Tongue Protrusion:~Genioglossus 7.5 units"
113561|NCT01921270|P1|Participant Flow|Dysport Injections|"Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.~Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.~Muscles that may be included for in injection for OMD with Jaw Closing:~Medial Pterygoid 50 units, Masseter 25 units~Muscles that may be included in injection for OMD with Jaw Opening:~Lateral Pterygoid 50 units, Anterior digastrics 10 units~Muscle that will be included in injection for OMD with Tongue Protrusion:~Genioglossus 7.5 units"
113562|NCT01921270|O1|Outcome|Dysport Injections|"Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.~Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.~Muscles that may be included for in injection for OMD with Jaw Closing:~Medial Pterygoid 50 units, Masseter 25 units~Muscles that may be included in injection for OMD with Jaw Opening:~Lateral Pterygoid 50 units, Anterior digastrics 10 units~Muscle that will be included in injection for OMD with Tongue Protrusion:~Genioglossus 7.5 units"
113563|NCT01921270|O1|Outcome|Dysport Injections|"Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.~Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.~Muscles that may be included for in injection for OMD with Jaw Closing:~Medial Pterygoid 50 units, Masseter 25 units~Muscles that may be included in injection for OMD with Jaw Opening:~Lateral Pterygoid 50 units, Anterior digastrics 10 units~Muscle that will be included in injection for OMD with Tongue Protrusion:~Genioglossus 7.5 units"
113564|NCT01921270|O1|Outcome|Dysport Injections|"Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.~Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.~Muscles that may be included for in injection for OMD with Jaw Closing:~Medial Pterygoid 50 units, Masseter 25 units~Muscles that may be included in injection for OMD with Jaw Opening:~Lateral Pterygoid 50 units, Anterior digastrics 10 units~Muscle that will be included in injection for OMD with Tongue Protrusion:~Genioglossus 7.5 units"
113565|NCT01921270|O1|Outcome|Dysport Injections|"Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.~Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.~Muscles that may be included for in injection for OMD with Jaw Closing:~Medial Pterygoid 50 units, Masseter 25 units~Muscles that may be included in injection for OMD with Jaw Opening:~Lateral Pterygoid 50 units, Anterior digastrics 10 units~Muscle that will be included in injection for OMD with Tongue Protrusion:~Genioglossus 7.5 units"
113566|NCT01921270|O1|Outcome|Dysport Injections|"Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.~Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.~Muscles that may be included for in injection for OMD with Jaw Closing:~Medial Pterygoid 50 units, Masseter 25 units~Muscles that may be included in injection for OMD with Jaw Opening:~Lateral Pterygoid 50 units, Anterior digastrics 10 units~Muscle that will be included in injection for OMD with Tongue Protrusion:~Genioglossus 7.5 units"
113567|NCT01921270|O1|Outcome|Dysport Injections|"Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.~Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.~Muscles that may be included for in injection for OMD with Jaw Closing:~Medial Pterygoid 50 units, Masseter 25 units~Muscles that may be included in injection for OMD with Jaw Opening:~Lateral Pterygoid 50 units, Anterior digastrics 10 units~Muscle that will be included in injection for OMD with Tongue Protrusion:~Genioglossus 7.5 units"
113568|NCT01921270|O1|Outcome|Dysport Injections|"Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.~Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.~Muscles that may be included for in injection for OMD with Jaw Closing:~Medial Pterygoid 50 units, Masseter 25 units~Muscles that may be included in injection for OMD with Jaw Opening:~Lateral Pterygoid 50 units, Anterior digastrics 10 units~Muscle that will be included in injection for OMD with Tongue Protrusion:~Genioglossus 7.5 units"
113569|NCT01921270|O1|Outcome|Dysport Injections|"Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.~Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.~Muscles that may be included for in injection for OMD with Jaw Closing:~Medial Pterygoid 50 units, Masseter 25 units~Muscles that may be included in injection for OMD with Jaw Opening:~Lateral Pterygoid 50 units, Anterior digastrics 10 units~Muscle that will be included in injection for OMD with Tongue Protrusion:~Genioglossus 7.5 units"
113570|NCT01921270|O1|Outcome|Dysport Injections|"Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.~Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.~Muscles that may be included for in injection for OMD with Jaw Closing:~Medial Pterygoid 50 units, Masseter 25 units~Muscles that may be included in injection for OMD with Jaw Opening:~Lateral Pterygoid 50 units, Anterior digastrics 10 units~Muscle that will be included in injection for OMD with Tongue Protrusion:~Genioglossus 7.5 units"
113571|NCT01921270|O1|Outcome|Dysport Injections|"Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.~Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.~Muscles that may be included for in injection for OMD with Jaw Closing:~Medial Pterygoid 50 units, Masseter 25 units~Muscles that may be included in injection for OMD with Jaw Opening:~Lateral Pterygoid 50 units, Anterior digastrics 10 units~Muscle that will be included in injection for OMD with Tongue Protrusion:~Genioglossus 7.5 units"
113572|NCT01921270|O1|Outcome|Dysport Injections|"Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.~Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.~Muscles that may be included for in injection for OMD with Jaw Closing:~Medial Pterygoid 50 units, Masseter 25 units~Muscles that may be included in injection for OMD with Jaw Opening:~Lateral Pterygoid 50 units, Anterior digastrics 10 units~Muscle that will be included in injection for OMD with Tongue Protrusion:~Genioglossus 7.5 units"
113573|NCT01921270|O1|Outcome|Dysport Injections|"Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.~Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.~Muscles that may be included for in injection for OMD with Jaw Closing:~Medial Pterygoid 50 units, Masseter 25 units~Muscles that may be included in injection for OMD with Jaw Opening:~Lateral Pterygoid 50 units, Anterior digastrics 10 units~Muscle that will be included in injection for OMD with Tongue Protrusion:~Genioglossus 7.5 units"
113574|NCT01921270|O1|Outcome|Dysport Injections|"Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.~Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.~Muscles that may be included for in injection for OMD with Jaw Closing:~Medial Pterygoid 50 units, Masseter 25 units~Muscles that may be included in injection for OMD with Jaw Opening:~Lateral Pterygoid 50 units, Anterior digastrics 10 units~Muscle that will be included in injection for OMD with Tongue Protrusion:~Genioglossus 7.5 units"
113575|NCT01921270|E1|Reported Event|Dysport Injections|"Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.~Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.~Muscles that may be included for in injection for OMD with Jaw Closing:~Medial Pterygoid 50 units, Masseter 25 units~Muscles that may be included in injection for OMD with Jaw Opening:~Lateral Pterygoid 50 units, Anterior digastrics 10 units~Muscle that will be included in injection for OMD with Tongue Protrusion:~Genioglossus 7.5 units"
113576|NCT01921257|B1|Baseline|Study Participants|Overall study participants
113577|NCT01921257|P1|Participant Flow|Placebo run-in Followed by Cat-PAD|All participants; received two intradermal doses of placebo (saline) followed by eight intradermal administrations of Cat-PAD.
113578|NCT01921257|O1|Outcome|Study Participants|Overall study participants
113579|NCT01921257|E2|Reported Event|Cat-PAD|Active treatment (Cat-PAD)
113580|NCT01921257|E1|Reported Event|Placebo run-in|Placebo run-in
113581|NCT01921205|B3|Baseline|Total Title|
113582|NCT01921205|B2|Baseline|Lacosamide|This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject’s body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
113583|NCT01921205|B1|Baseline|Placebo|This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
113584|NCT01921205|P2|Participant Flow|Lacosamide|This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject’s body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
113585|NCT01921205|P1|Participant Flow|Placebo|This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
113586|NCT01921205|O2|Outcome|Lacosamide (FAS)|This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject’s body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
113587|NCT01921205|O1|Outcome|Placebo (FAS)|This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
113588|NCT01921205|O2|Outcome|Lacosamide (FAS)|This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject’s body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
113589|NCT01921205|O1|Outcome|Placebo (FAS)|This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
113590|NCT01921205|O2|Outcome|Lacosamide (FAS)|This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject’s body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
113591|NCT01921205|O1|Outcome|Placebo (FAS)|This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
113592|NCT01921205|O2|Outcome|Lacosamide (FAS)|This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject’s body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
113593|NCT01921205|O1|Outcome|Placebo (FAS)|This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
113594|NCT01921205|O2|Outcome|Lacosamide (FAS)|This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject’s body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
113595|NCT01921205|O1|Outcome|Placebo (FAS)|This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
113596|NCT01921205|O2|Outcome|Lacosamide (FAS)|This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject’s body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
119475|NCT01890694|O2|Outcome|Placebo|Study Terminated. No data analyzed
113598|NCT01921205|O2|Outcome|Lacosamide (FAS)|This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject’s body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
113599|NCT01921205|O1|Outcome|Placebo (FAS)|This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
113600|NCT01921205|O2|Outcome|Lacosamide (FAS)|This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject’s body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
113601|NCT01921205|O1|Outcome|Placebo (FAS)|This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
113602|NCT01921205|O2|Outcome|Lacosamide (FAS)|This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject’s body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
113603|NCT01921205|O1|Outcome|Placebo (FAS)|This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
113604|NCT01921205|O2|Outcome|Lacosamide (FAS)|This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject’s body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
113605|NCT01921205|O1|Outcome|Placebo (FAS)|This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
113606|NCT01921205|O2|Outcome|Lacosamide (FAS)|This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject’s body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
113607|NCT01921205|O1|Outcome|Placebo (FAS)|This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
113608|NCT01921205|O2|Outcome|Lacosamide (FAS)|This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject’s body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
113609|NCT01921205|O1|Outcome|Placebo (FAS)|This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
113610|NCT01921205|E2|Reported Event|Lacosamide|This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject’s body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
113611|NCT01921205|E1|Reported Event|Placebo|This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
113612|NCT01921166|B3|Baseline|Total|Total of all reporting groups
113613|NCT01921166|B2|Baseline|Leuprolide Flare|"Leuprolide flare~Leuprolide flare: Leuprolide flare ovulation induction"
113614|NCT01921166|B1|Baseline|Clomiphene Plus Gonadotropins|"clomiphene plus gonadotropins~clomiphene plus gonadotropins: clomiphene plus gonadotropin ovulation induction"
113615|NCT01921166|P2|Participant Flow|Leuprolide Flare|"Leuprolide flare~Leuprolide flare: Leuprolide flare ovulation induction"
113616|NCT01921166|P1|Participant Flow|Clomiphene Plus Gonadotropins|"clomiphene plus gonadotropins~clomiphene plus gonadotropins: clomiphene plus gonadotropin ovulation induction"
113621|NCT01921166|E2|Reported Event|Leuprolide Flare|"Leuprolide flare~Leuprolide flare: Leuprolide flare ovulation induction"
113622|NCT01921166|E1|Reported Event|Clomiphene Plus Gonadotropins|"clomiphene plus gonadotropins~clomiphene plus gonadotropins: clomiphene plus gonadotropin ovulation induction"
113623|NCT01921101|B3|Baseline|Total|Total of all reporting groups
113624|NCT01921101|B2|Baseline|Control|"participants will not receive intensive nutritional support from hospital admission to discharge~control: participants will receive standard care for nutrition received from hospital admission to discharge"
113625|NCT01921101|B1|Baseline|Intensive Medical Nutrition|"participants will receive intensive medical nutrition from hospital admission to discharge~intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge"
113626|NCT01921101|P2|Participant Flow|Control|"participants will not receive intensive nutritional support from hospital admission to discharge~control: participants will receive standard care for nutrition received from hospital admission to discharge"
113627|NCT01921101|P1|Participant Flow|Intensive Medical Nutrition|"participants will receive intensive medical nutrition from hospital admission to discharge~intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge"
113628|NCT01921101|O2|Outcome|Control|"participants will not receive intensive nutritional support from hospital admission to discharge~control: participants will receive standard care for nutrition received from hospital admission to discharge"
113629|NCT01921101|O1|Outcome|Intensive Medical Nutrition|"participants will receive intensive medical nutrition from hospital admission to discharge~intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge"
113630|NCT01921101|O2|Outcome|Control|"participants will not receive intensive nutritional support from hospital admission to discharge~control: participants will receive standard care for nutrition received from hospital admission to discharge"
113631|NCT01921101|O1|Outcome|Intensive Medical Nutrition|"participants will receive intensive medical nutrition from hospital admission to discharge~intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge"
113632|NCT01921101|E2|Reported Event|Control|"participants will not receive intensive nutritional support from hospital admission to discharge~control: participants will receive standard care for nutrition received from hospital admission to discharge"
113633|NCT01921101|E1|Reported Event|Intensive Medical Nutrition|"participants will receive intensive medical nutrition from hospital admission to discharge~intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge"
113634|NCT01920958|B1|Baseline|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
113635|NCT01920958|P1|Participant Flow|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
113636|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
113637|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
113638|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
113639|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
113640|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
113641|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
113642|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
113643|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
113644|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
113645|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
113646|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
113647|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
113648|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
113649|NCT01920958|E1|Reported Event|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
113650|NCT01920893|B3|Baseline|Total|Total of all reporting groups
113651|NCT01920893|B2|Baseline|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
113652|NCT01920893|B1|Baseline|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
113653|NCT01920893|P2|Participant Flow|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
113654|NCT01920893|P1|Participant Flow|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection every week (QW) from Week 1 to 15 added to MFNS.
113655|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
113656|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
113657|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
113658|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
113659|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection every week from Week 1 to 15 added to MFNS.
113660|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
113661|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
113662|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
113663|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
113664|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
113665|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
113666|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
113667|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
113668|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
113669|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
113670|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
113671|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
113672|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
113673|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
113674|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
113675|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
113676|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
113677|NCT01920893|E2|Reported Event|Dupilumab 300 mg QW|Participants exposed to dupilumab added to MFNS (mean exposure of 16 weeks).
113678|NCT01920893|E1|Reported Event|Placebo|Participants exposed to placebo (for dupilumab) added to MFNS (mean exposure of 14 weeks).
113679|NCT01920854|B8|Baseline|Total|Total of all reporting groups
113680|NCT01920854|B7|Baseline|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
113681|NCT01920854|B6|Baseline|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
113682|NCT01920854|B5|Baseline|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
113683|NCT01920854|B4|Baseline|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
113684|NCT01920854|B3|Baseline|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
113685|NCT01920854|B2|Baseline|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
113686|NCT01920854|B1|Baseline|Cohorts 1 - 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).
113687|NCT01920854|P7|Participant Flow|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
113688|NCT01920854|P6|Participant Flow|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
113689|NCT01920854|P5|Participant Flow|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
113690|NCT01920854|P4|Participant Flow|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
113691|NCT01920854|P3|Participant Flow|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
113692|NCT01920854|P2|Participant Flow|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
113693|NCT01920854|P1|Participant Flow|Cohorts 1 - 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).
113694|NCT01920854|O7|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
113695|NCT01920854|O6|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
113696|NCT01920854|O5|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
113697|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
113698|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
113699|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
113700|NCT01920854|O1|Outcome|Cohorts 1 - 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).
113701|NCT01920854|O6|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
113702|NCT01920854|O5|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
113819|NCT01920802|B1|Baseline|Olanzapine|"5mg BID olanzapine for up to 4 weeks~olanzapine: 5mg BID up to 4 weeks"
113820|NCT01920802|P3|Participant Flow|Placebo|"BID placebo up to 4 weeks~Placebo: BID up to 4 weeks"
113703|NCT01920854|O4|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
113704|NCT01920854|O3|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
113705|NCT01920854|O2|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
113706|NCT01920854|O1|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
113707|NCT01920854|O6|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
113708|NCT01920854|O5|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
113709|NCT01920854|O4|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
113710|NCT01920854|O3|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
113711|NCT01920854|O2|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
113712|NCT01920854|O1|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
113713|NCT01920854|O6|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
113714|NCT01920854|O5|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
113715|NCT01920854|O4|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
113716|NCT01920854|O3|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
113717|NCT01920854|O2|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
113718|NCT01920854|O1|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
113719|NCT01920854|O6|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
113720|NCT01920854|O5|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
113721|NCT01920854|O4|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
113821|NCT01920802|P2|Participant Flow|Iloperidone|"6mg BID iloperidone up to 4 weeks~iloperidone: 6 mg BID up to 4 weeks"
113722|NCT01920854|O3|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
113723|NCT01920854|O2|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
113724|NCT01920854|O1|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
113725|NCT01920854|O8|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
113726|NCT01920854|O7|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
113727|NCT01920854|O6|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
113728|NCT01920854|O5|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
113729|NCT01920854|O4|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
113730|NCT01920854|O3|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
113731|NCT01920854|O2|Outcome|Cohorts 4, 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4, 5 Placebo received IV D5W infused over 12 hours.
113732|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 -3, 6 Placebo received IV D5W infused over 4 hours.
113733|NCT01920854|O8|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
113734|NCT01920854|O7|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
113735|NCT01920854|O6|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
113736|NCT01920854|O5|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
113737|NCT01920854|O4|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
113738|NCT01920854|O3|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
113739|NCT01920854|O2|Outcome|Cohorts 4, 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4, 5 Placebo received IV D5W infused over 12 hours.
113740|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 -3, 6 Placebo received IV D5W infused over 4 hours.
136494|NCT01806857|O2|Outcome|Matching Placebo|
113741|NCT01920854|O6|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
113742|NCT01920854|O5|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
113743|NCT01920854|O4|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
113744|NCT01920854|O3|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
113745|NCT01920854|O2|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
113746|NCT01920854|O1|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
113747|NCT01920854|O6|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
113748|NCT01920854|O5|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
113749|NCT01920854|O4|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
113750|NCT01920854|O3|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
113751|NCT01920854|O2|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
113752|NCT01920854|O1|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
113753|NCT01920854|O8|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
113754|NCT01920854|O7|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
113755|NCT01920854|O6|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
113756|NCT01920854|O5|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
113757|NCT01920854|O4|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
113758|NCT01920854|O3|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
113759|NCT01920854|O2|Outcome|Cohorts 4, 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4, 5 Placebo received IV D5W infused over 12 hours.
113822|NCT01920802|P1|Participant Flow|Olanzapine|"5mg BID olanzapine for up to 4 weeks~olanzapine: 5mg BID up to 4 weeks"
113760|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 -3, 6 Placebo received IV D5W infused over 4 hours.
113761|NCT01920854|O3|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
113762|NCT01920854|O2|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
113763|NCT01920854|O1|Outcome|Cohorts 4 and 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
113764|NCT01920854|O5|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
113765|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
113766|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
113767|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
113768|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
113769|NCT01920854|O3|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
113770|NCT01920854|O2|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
113771|NCT01920854|O1|Outcome|Cohorts 4 and 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
113772|NCT01920854|O5|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
113773|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
113774|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
113775|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
113776|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
113777|NCT01920854|O3|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
113778|NCT01920854|O2|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
136495|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
113779|NCT01920854|O1|Outcome|Cohorts 4 and 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
113780|NCT01920854|O5|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
113781|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
113782|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
113783|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
113784|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
113785|NCT01920854|O3|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
113786|NCT01920854|O2|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
113787|NCT01920854|O1|Outcome|Cohorts 4 and 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
113788|NCT01920854|O5|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
113789|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
113790|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
113791|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
113792|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
113793|NCT01920854|O3|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
113794|NCT01920854|O2|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
113795|NCT01920854|O1|Outcome|Cohorts 4 and 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
113796|NCT01920854|O5|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
113797|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
136496|NCT01806857|O2|Outcome|Matching Placebo|
113798|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
113799|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
113800|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
113801|NCT01920854|O3|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
113802|NCT01920854|O2|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
113803|NCT01920854|O1|Outcome|Cohorts 4 and 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
113804|NCT01920854|O5|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
113805|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
113806|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
113807|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
113808|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
113809|NCT01920854|E7|Reported Event|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
113810|NCT01920854|E6|Reported Event|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
113811|NCT01920854|E5|Reported Event|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
113812|NCT01920854|E4|Reported Event|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
113813|NCT01920854|E3|Reported Event|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
113814|NCT01920854|E2|Reported Event|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
113815|NCT01920854|E1|Reported Event|Cohorts 1 - 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).
113816|NCT01920802|B4|Baseline|Total|Total of all reporting groups
113817|NCT01920802|B3|Baseline|Placebo|"BID placebo up to 4 weeks~Placebo: BID up to 4 weeks"
113818|NCT01920802|B2|Baseline|Iloperidone|"6mg BID iloperidone up to 4 weeks~iloperidone: 6 mg BID up to 4 weeks"
113824|NCT01920802|O2|Outcome|Iloperidone|"6mg BID iloperidone up to 4 weeks~iloperidone: 6 mg BID up to 4 weeks"
113825|NCT01920802|O1|Outcome|Olanzapine|"5mg BID olanzapine for up to 4 weeks~olanzapine: 5mg BID up to 4 weeks"
113826|NCT01920802|O3|Outcome|Placebo|"BID placebo up to 4 weeks~Placebo: BID up to 4 weeks"
113827|NCT01920802|O2|Outcome|Iloperidone|"6mg BID iloperidone up to 4 weeks~iloperidone: 6 mg BID up to 4 weeks"
113828|NCT01920802|O1|Outcome|Olanzapine|"5mg BID olanzapine for up to 4 weeks~olanzapine: 5mg BID up to 4 weeks"
113829|NCT01920802|O3|Outcome|Placebo|"BID placebo up to 4 weeks~Placebo: BID up to 4 weeks"
113830|NCT01920802|O2|Outcome|Iloperidone|"6mg BID iloperidone up to 4 weeks~iloperidone: 6 mg BID up to 4 weeks"
113831|NCT01920802|O1|Outcome|Olanzapine|"5mg BID olanzapine for up to 4 weeks~olanzapine: 5mg BID up to 4 weeks"
113832|NCT01920802|O3|Outcome|Placebo|"BID placebo up to 4 weeks~Placebo: BID up to 4 weeks"
113833|NCT01920802|O2|Outcome|Iloperidone|"6mg BID iloperidone up to 4 weeks~iloperidone: 6 mg BID up to 4 weeks"
113834|NCT01920802|O1|Outcome|Olanzapine|"5mg BID olanzapine for up to 4 weeks~olanzapine: 5mg BID up to 4 weeks"
113835|NCT01920802|O3|Outcome|Placebo|"BID placebo up to 4 weeks~Placebo: BID up to 4 weeks"
113836|NCT01920802|O2|Outcome|Iloperidone|"6mg BID iloperidone up to 4 weeks~iloperidone: 6 mg BID up to 4 weeks"
113837|NCT01920802|O1|Outcome|Olanzapine|"5mg BID olanzapine for up to 4 weeks~olanzapine: 5mg BID up to 4 weeks"
113838|NCT01920802|O3|Outcome|Placebo|"BID placebo up to 4 weeks~Placebo: BID up to 4 weeks"
113839|NCT01920802|O2|Outcome|Iloperidone|"6mg BID iloperidone up to 4 weeks~iloperidone: 6 mg BID up to 4 weeks"
113840|NCT01920802|O1|Outcome|Olanzapine|"5mg BID olanzapine for up to 4 weeks~olanzapine: 5mg BID up to 4 weeks"
113841|NCT01920802|O3|Outcome|Placebo|"BID placebo up to 4 weeks~Placebo: BID up to 4 weeks"
113842|NCT01920802|O2|Outcome|Iloperidone|"6mg BID iloperidone up to 4 weeks~iloperidone: 6 mg BID up to 4 weeks"
113843|NCT01920802|O1|Outcome|Olanzapine|"5mg BID olanzapine for up to 4 weeks~olanzapine: 5mg BID up to 4 weeks"
113844|NCT01920802|O3|Outcome|Placebo|"BID placebo up to 4 weeks~Placebo: BID up to 4 weeks"
113845|NCT01920802|O2|Outcome|Iloperidone|"6mg BID iloperidone up to 4 weeks~iloperidone: 6 mg BID up to 4 weeks"
113846|NCT01920802|O1|Outcome|Olanzapine|"5mg BID olanzapine for up to 4 weeks~olanzapine: 5mg BID up to 4 weeks"
113847|NCT01920802|E3|Reported Event|Placebo|"BID placebo up to 4 weeks~Placebo: BID up to 4 weeks"
113848|NCT01920802|E2|Reported Event|Iloperidone|"6mg BID iloperidone up to 4 weeks~iloperidone: 6 mg BID up to 4 weeks"
113849|NCT01920802|E1|Reported Event|Olanzapine|"5mg BID olanzapine for up to 4 weeks~olanzapine: 5mg BID up to 4 weeks"
113850|NCT01920594|B3|Baseline|Total|Total of all reporting groups
113851|NCT01920594|B2|Baseline|Placebo|Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113852|NCT01920594|B1|Baseline|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113853|NCT01920594|P2|Participant Flow|Placebo|Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113854|NCT01920594|P1|Participant Flow|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 milligrams (mg) on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg once daily (QD) for 4 days starting from Day 0 (surgical day).
113855|NCT01920594|O1|Outcome|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113856|NCT01920594|O1|Outcome|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113857|NCT01920594|O1|Outcome|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113858|NCT01920594|O1|Outcome|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113859|NCT01920594|O1|Outcome|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113860|NCT01920594|O1|Outcome|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113861|NCT01920594|O2|Outcome|Placebo|Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113862|NCT01920594|O1|Outcome|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113863|NCT01920594|O2|Outcome|Placebo|Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113864|NCT01920594|O1|Outcome|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113865|NCT01920594|O2|Outcome|Placebo|Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113866|NCT01920594|O1|Outcome|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113867|NCT01920594|O2|Outcome|Placebo|Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113868|NCT01920594|O1|Outcome|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113869|NCT01920594|O2|Outcome|Placebo|Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113870|NCT01920594|O1|Outcome|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113871|NCT01920594|O2|Outcome|Placebo|Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113872|NCT01920594|O1|Outcome|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113873|NCT01920594|O2|Outcome|Placebo|Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113874|NCT01920594|O1|Outcome|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113875|NCT01920594|O2|Outcome|Placebo|Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113876|NCT01920594|O1|Outcome|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113877|NCT01920594|O2|Outcome|Placebo|Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113878|NCT01920594|O1|Outcome|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113879|NCT01920594|O2|Outcome|Placebo|Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113880|NCT01920594|O1|Outcome|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113881|NCT01920594|O2|Outcome|Placebo|Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113882|NCT01920594|O1|Outcome|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113883|NCT01920594|O2|Outcome|Placebo|Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113884|NCT01920594|O1|Outcome|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113885|NCT01920594|O2|Outcome|Placebo|Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113886|NCT01920594|O1|Outcome|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113887|NCT01920594|O2|Outcome|Placebo|Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113888|NCT01920594|O1|Outcome|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113889|NCT01920594|O2|Outcome|Placebo|Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113890|NCT01920594|O1|Outcome|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113891|NCT01920594|O2|Outcome|Placebo|Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113892|NCT01920594|O1|Outcome|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113893|NCT01920594|O2|Outcome|Placebo|Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113894|NCT01920594|O1|Outcome|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113895|NCT01920594|O2|Outcome|Placebo|Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113896|NCT01920594|O1|Outcome|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113897|NCT01920594|O2|Outcome|Placebo|Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113898|NCT01920594|O1|Outcome|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113899|NCT01920594|E2|Reported Event|Placebo|Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113900|NCT01920594|E1|Reported Event|GSK1278863 300 mg Loading + 100 mg QD|Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
113901|NCT01920568|B3|Baseline|Total|Total of all reporting groups
113902|NCT01920568|B2|Baseline|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
113903|NCT01920568|B1|Baseline|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
113904|NCT01920568|P2|Participant Flow|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
113905|NCT01920568|P1|Participant Flow|Denosumab 120 mg|Participants received denosumab 120 milligrams (mg) as subcutaneous (SC) injection for a maximum of 13 doses and placebo as intravenous (IV) infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 international unit (IU) of vitamin D.
113906|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
113907|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
113908|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
113909|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
113910|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
113911|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
113912|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
113913|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
113914|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
113915|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
113916|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
119476|NCT01890694|O1|Outcome|Tolvaptan|Subjects will receive Tolvaptan once daily.
113917|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
113918|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
113919|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
113920|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
113921|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
113922|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
113923|NCT01920568|E2|Reported Event|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
113924|NCT01920568|E1|Reported Event|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
113925|NCT01920555|B6|Baseline|Total|Total of all reporting groups
113926|NCT01920555|B5|Baseline|Midazolam (Active Placebo)|"Patients in this arm will receive 0.045 mg/kg of midazolam - one single infusion~Placebo Midazolam: Dose of Midazolam (active placebo) will be 0.045 mg/kg - one single infusion"
113927|NCT01920555|B4|Baseline|Ketamine 1.0mg|"Patients in this arm will receive 1.0 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 1.0 mg/kg - one single infusion"
113928|NCT01920555|B3|Baseline|Ketamine 0.5mg|"Patients in this arm will receive 0.5 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.5 mg/kg - one single infusion"
113929|NCT01920555|B2|Baseline|Ketamine 0.2mg|"Patients in this arm will receive 0.2 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.2 mg/kg - one single infusion"
113930|NCT01920555|B1|Baseline|Ketamine 0.1mg|"Patients in this arm will receive 0.1 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.1 mg/kg - one single infusion"
113931|NCT01920555|P5|Participant Flow|Midazolam (Active Placebo)|"Patients in this arm will receive 0.045 mg/kg of midazolam - one single infusion~Placebo Midazolam: Dose of Midazolam (active placebo) will be 0.045 mg/kg - one single infusion"
113932|NCT01920555|P4|Participant Flow|Ketamine 1.0mg|"Patients in this arm will receive 1.0 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 1.0 mg/kg - one single infusion"
113933|NCT01920555|P3|Participant Flow|Ketamine 0.5mg|"Patients in this arm will receive 0.5 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.5 mg/kg - one single infusion"
113934|NCT01920555|P2|Participant Flow|Ketamine 0.2mg|"Patients in this arm will receive 0.2 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.2 mg/kg - one single infusion"
113935|NCT01920555|P1|Participant Flow|Ketamine 0.1mg|"Patients in this arm will receive 0.1 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.1 mg/kg - one single infusion"
113936|NCT01920555|O5|Outcome|Midazolam 0.045mg|Patients in this arm will receive 0.045 mg/kg of Midazolam (active placebo) - one single infusion
113937|NCT01920555|O4|Outcome|Ketamine 1.0mg|"Patients in this arm will receive 1.0 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 1.0 mg/kg - one single infusion"
113938|NCT01920555|O3|Outcome|Ketamine 0.5mg|"Patients in this arm will receive 0.5 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.5 mg/kg - one single infusion"
113939|NCT01920555|O2|Outcome|Ketamine 0.2mg|"Patients in this arm will receive 0.2 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.2 mg/kg - one single infusion"
113940|NCT01920555|O1|Outcome|Ketamine 0.1mg|"Patients in this arm will receive 0.1 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.1 mg/kg - one single infusion"
113941|NCT01920555|O5|Outcome|Midazolam 0.045mg|Patients in this arm will receive 0.045 mg/kg of Midazolam (active placebo) - one single infusion
113942|NCT01920555|O4|Outcome|Ketamine 1.0mg|"Patients in this arm will receive 1.0 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 1.0 mg/kg - one single infusion"
113943|NCT01920555|O3|Outcome|Ketamine 0.5mg|"Patients in this arm will receive 0.5 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.5 mg/kg - one single infusion"
113944|NCT01920555|O2|Outcome|Ketamine 0.2mg|"Patients in this arm will receive 0.2 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.2 mg/kg - one single infusion"
113945|NCT01920555|O1|Outcome|Ketamine 0.1mg|"Patients in this arm will receive 0.1 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.1 mg/kg - one single infusion"
113946|NCT01920555|O5|Outcome|Midazolam 0.045mg|Patients in this arm will receive 0.045 mg/kg of Midazolam (active placebo) - one single infusion
113947|NCT01920555|O4|Outcome|Ketamine 1.0mg|"Patients in this arm will receive 1.0 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 1.0 mg/kg - one single infusion"
113948|NCT01920555|O3|Outcome|Ketamine 0.5mg|"Patients in this arm will receive 0.5 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.5 mg/kg - one single infusion"
119477|NCT01890694|O2|Outcome|Placebo|Study Terminated. No data analyzed
113949|NCT01920555|O2|Outcome|Ketamine 0.2mg|"Patients in this arm will receive 0.2 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.2 mg/kg - one single infusion"
113950|NCT01920555|O1|Outcome|Ketamine 0.1mg|"Patients in this arm will receive 0.1 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.1 mg/kg - one single infusion"
113951|NCT01920555|O5|Outcome|Midazolam 0.045mg|Patients in this arm will receive 0.045 mg/kg of Midazolam (active placebo) - one single infusion
113952|NCT01920555|O4|Outcome|Ketamine 1.0mg|"Patients in this arm will receive 1.0 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 1.0 mg/kg - one single infusion"
113953|NCT01920555|O3|Outcome|Ketamine 0.5mg|"Patients in this arm will receive 0.5 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.5 mg/kg - one single infusion"
113954|NCT01920555|O2|Outcome|Ketamine 0.2mg|"Patients in this arm will receive 0.2 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.2 mg/kg - one single infusion"
113955|NCT01920555|O1|Outcome|Ketamine 0.1mg|"Patients in this arm will receive 0.1 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.1 mg/kg - one single infusion"
113956|NCT01920555|O5|Outcome|Midazolam 0.045mg|Patients in this arm will receive 0.045 mg/kg of Midazolam (active placebo) - one single infusion
113957|NCT01920555|O4|Outcome|Ketamine 1.0mg|"Patients in this arm will receive 1.0 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 1.0 mg/kg - one single infusion"
113958|NCT01920555|O3|Outcome|Ketamine 0.5mg|"Patients in this arm will receive 0.5 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.5 mg/kg - one single infusion"
113959|NCT01920555|O2|Outcome|Ketamine 0.2mg|"Patients in this arm will receive 0.2 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.2 mg/kg - one single infusion"
113960|NCT01920555|O1|Outcome|Ketamine 0.1mg|"Patients in this arm will receive 0.1 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.1 mg/kg - one single infusion"
113961|NCT01920555|O5|Outcome|Midazolam 0.045mg|Patients in this arm will receive 0.045 mg/kg of Midazolam (active placebo) - one single infusion
113962|NCT01920555|O4|Outcome|Ketamine 1.0mg|"Patients in this arm will receive 1.0 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 1.0 mg/kg - one single infusion"
113963|NCT01920555|O3|Outcome|Ketamine 0.5mg|"Patients in this arm will receive 0.5 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.5 mg/kg - one single infusion"
113964|NCT01920555|O2|Outcome|Ketamine 0.2mg|"Patients in this arm will receive 0.2 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.2 mg/kg - one single infusion"
113965|NCT01920555|O1|Outcome|Ketamine 0.1mg|"Patients in this arm will receive 0.1 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.1 mg/kg - one single infusion"
113966|NCT01920555|O5|Outcome|Midazolam 0.045mg|Patients in this arm will receive 0.045 mg/kg of Midazolam (active placebo) - one single infusion
113967|NCT01920555|O4|Outcome|Ketamine 1.0mg|"Patients in this arm will receive 1.0 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 1.0 mg/kg - one single infusion"
113968|NCT01920555|O3|Outcome|Ketamine 0.5mg|"Patients in this arm will receive 0.5 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.5 mg/kg - one single infusion"
113969|NCT01920555|O2|Outcome|Ketamine 0.2mg|"Patients in this arm will receive 0.2 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.2 mg/kg - one single infusion"
113970|NCT01920555|O1|Outcome|Ketamine 0.1mg|"Patients in this arm will receive 0.1 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.1 mg/kg - one single infusion"
113971|NCT01920555|O5|Outcome|Midazolam 0.045mg|Patients in this arm will receive 0.045 mg/kg of Midazolam (active placebo) - one single infusion
113972|NCT01920555|O4|Outcome|Ketamine 1.0mg|"Patients in this arm will receive 1.0 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 1.0 mg/kg - one single infusion"
113973|NCT01920555|O3|Outcome|Ketamine 0.5mg|"Patients in this arm will receive 0.5 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.5 mg/kg - one single infusion"
113974|NCT01920555|O2|Outcome|Ketamine 0.2mg|"Patients in this arm will receive 0.2 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.2 mg/kg - one single infusion"
113975|NCT01920555|O1|Outcome|Ketamine 0.1mg|"Patients in this arm will receive 0.1 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.1 mg/kg - one single infusion"
113976|NCT01920555|O5|Outcome|Midazolam 0.045mg|Patients in this arm will receive 0.045 mg/kg of Midazolam (active placebo) - one single infusion
113977|NCT01920555|O4|Outcome|Ketamine 1.0mg|"Patients in this arm will receive 1.0 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 1.0 mg/kg - one single infusion"
113978|NCT01920555|O3|Outcome|Ketamine 0.5mg|"Patients in this arm will receive 0.5 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.5 mg/kg - one single infusion"
113979|NCT01920555|O2|Outcome|Ketamine 0.2mg|"Patients in this arm will receive 0.2 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.2 mg/kg - one single infusion"
113980|NCT01920555|O1|Outcome|Ketamine 0.1mg|"Patients in this arm will receive 0.1 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.1 mg/kg - one single infusion"
113981|NCT01920555|O5|Outcome|Midazolam 0.045mg|Patients in this arm will receive 0.045 mg/kg of Midazolam (active placebo) - one single infusion
113982|NCT01920555|O4|Outcome|Ketamine 1.0mg|"Patients in this arm will receive 1.0 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 1.0 mg/kg - one single infusion"
113983|NCT01920555|O3|Outcome|Ketamine 0.5mg|"Patients in this arm will receive 0.5 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.5 mg/kg - one single infusion"
113984|NCT01920555|O2|Outcome|Ketamine 0.2mg|"Patients in this arm will receive 0.2 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.2 mg/kg - one single infusion"
113985|NCT01920555|O1|Outcome|Ketamine 0.1mg|"Patients in this arm will receive 0.1 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.1 mg/kg - one single infusion"
113986|NCT01920555|E5|Reported Event|Midazolam (Active Placebo)|"Patients in this arm will receive 0.045 mg/kg of midazolam - one single infusion~Placebo Midazolam: Dose of Midazolam (active placebo) will be 0.045 mg/kg - one single infusion"
113987|NCT01920555|E4|Reported Event|Ketamine 1.0mg|"Patients in this arm will receive 1.0 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 1.0 mg/kg - one single infusion"
113988|NCT01920555|E3|Reported Event|Ketamine 0.5mg|"Patients in this arm will receive 0.5 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.5 mg/kg - one single infusion"
113989|NCT01920555|E2|Reported Event|Ketamine 0.2mg|"Patients in this arm will receive 0.2 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.2 mg/kg - one single infusion"
113990|NCT01920555|E1|Reported Event|Ketamine 0.1mg|"Patients in this arm will receive 0.1 mg/kg of Ketamine - one single infusion~Ketamine: Dose of Ketamine will be 0.1 mg/kg - one single infusion"
113991|NCT01920282|B4|Baseline|Total|Total of all reporting groups
113992|NCT01920282|B3|Baseline|Nebivolol Plus Lifestyle Modification|"Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Nebivolol plus Lifestyle Modification"
113993|NCT01920282|B2|Baseline|Lifestyle Modification|"Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Lifestyle Modification"
113994|NCT01920282|B1|Baseline|Nebivolol|"Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.~Nebivolol"
113995|NCT01920282|P3|Participant Flow|Nebivolol Plus Lifestyle Modification|"Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Nebivolol plus Lifestyle Modification"
113996|NCT01920282|P2|Participant Flow|Lifestyle Modification|"Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Lifestyle Modification"
113997|NCT01920282|P1|Participant Flow|Nebivolol|"Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.~Nebivolol"
113998|NCT01920282|O3|Outcome|Nebivolol Plus Lifestyle Modification|"Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Nebivolol plus Lifestyle Modification"
113999|NCT01920282|O2|Outcome|Lifestyle Modification|"Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Lifestyle Modification"
114000|NCT01920282|O1|Outcome|Nebivolol|"Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.~Nebivolol"
114699|NCT01915849|O2|Outcome|LIK066 50 mg|All patients who have received LIK066 50 mg once daily for 4 days.
114001|NCT01920282|O3|Outcome|Nebivolol Plus Lifestyle Modification|"Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Nebivolol plus Lifestyle Modification"
114002|NCT01920282|O2|Outcome|Lifestyle Modification|"Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Lifestyle Modification"
114003|NCT01920282|O1|Outcome|Nebivolol|"Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.~Nebivolol"
114004|NCT01920282|E3|Reported Event|Nebivolol Plus Lifestyle Modification|"Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Nebivolol plus Lifestyle Modification"
114005|NCT01920282|E2|Reported Event|Lifestyle Modification|"Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Lifestyle Modification"
114006|NCT01920282|E1|Reported Event|Nebivolol|"Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.~Nebivolol"
114007|NCT01920178|B3|Baseline|Total|Total of all reporting groups
114008|NCT01920178|B2|Baseline|Sham Laser Group|"Treatment with only localizing (aiming) beam of Pinpointe Foot Laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
114009|NCT01920178|B1|Baseline|PinPointe Foot Laser|"Active laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
114010|NCT01920178|P2|Participant Flow|Sham Laser Group|"Treatment with only localizing (aiming) beam of Pinpointe Foot Laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
114011|NCT01920178|P1|Participant Flow|PinPointe Foot Laser|"Active laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
114012|NCT01920178|O2|Outcome|Sham Laser Group|"Treatment with only localizing (aiming) beam of Pinpointe Foot Laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
114013|NCT01920178|O1|Outcome|PinPointe Foot Laser|"Active laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
114014|NCT01920178|O2|Outcome|Sham Laser Group|"Treatment with only localizing (aiming) beam of Pinpointe Foot Laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
114015|NCT01920178|O1|Outcome|PinPointe Foot Laser|"Active laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
114016|NCT01920178|O2|Outcome|Sham Laser Group|"Treatment with only localizing (aiming) beam of Pinpointe Foot Laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
114051|NCT01919801|E1|Reported Event|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
114017|NCT01920178|O1|Outcome|PinPointe Foot Laser|"Active laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
114018|NCT01920178|E2|Reported Event|Sham Laser Group|"Treatment with only localizing (aiming) beam of Pinpointe Foot Laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
114019|NCT01920178|E1|Reported Event|PinPointe Foot Laser|"Active laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
114020|NCT01919996|B1|Baseline|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
114021|NCT01919996|P1|Participant Flow|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
114022|NCT01919996|O1|Outcome|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
114023|NCT01919996|O1|Outcome|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
114024|NCT01919996|O1|Outcome|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
114025|NCT01919996|E1|Reported Event|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
114026|NCT01919801|B3|Baseline|Total|Total of all reporting groups
114027|NCT01919801|B2|Baseline|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
114028|NCT01919801|B1|Baseline|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
114029|NCT01919801|P2|Participant Flow|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
114030|NCT01919801|P1|Participant Flow|Icatibant 30 mg|Participants received a single dose of icatibant 30 milligram (mg) subcutaneous (SC) injection within 12 hours after the onset of the angiotensin-converting enzyme inhibitor (ACE-I) induced angioedema attack.
114031|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
114032|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
114033|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
114034|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
114035|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
114036|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
114037|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
114038|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
114039|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
114040|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
114041|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
114042|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
114043|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
114044|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
114045|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
114046|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
114047|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
114048|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
114049|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
114050|NCT01919801|E2|Reported Event|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
114052|NCT01919723|B3|Baseline|Total|Total of all reporting groups
136497|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
114053|NCT01919723|B2|Baseline|Ticagrelor & Eptifibatide Bolus+Infusion|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)~Ticagrelor: Ticagrelor loading dose~Eptifibatide: i.v. infusion"
114054|NCT01919723|B1|Baseline|Ticagrelor and Eptifibatide Bolus|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)~Ticagrelor: Ticagrelor loading dose~Eptifibatide: i.v. infusion"
114055|NCT01919723|P2|Participant Flow|Ticagrelor & Eptifibatide Bolus+Infusion|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
114056|NCT01919723|P1|Participant Flow|Ticagrelor and Eptifibatide Bolus|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
114057|NCT01919723|O2|Outcome|Ticagrelor & Eptifibatide Bolus+Infusion|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
114058|NCT01919723|O1|Outcome|Ticagrelor and Eptifibatide Bolus|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
114059|NCT01919723|O2|Outcome|Ticagrelor & Eptifibatide Bolus+Infusion|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
114060|NCT01919723|O1|Outcome|Ticagrelor and Eptifibatide Bolus|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
114061|NCT01919723|O2|Outcome|Ticagrelor & Eptifibatide Bolus+Infusion|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
114062|NCT01919723|O1|Outcome|Ticagrelor and Eptifibatide Bolus|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
114063|NCT01919723|O2|Outcome|Ticagrelor & Eptifibatide Bolus+Infusion|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
114064|NCT01919723|O1|Outcome|Ticagrelor and Eptifibatide Bolus|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
114065|NCT01919723|E2|Reported Event|Ticagrelor & Eptifibatide Bolus+Infusion|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
114066|NCT01919723|E1|Reported Event|Ticagrelor and Eptifibatide Bolus|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
114067|NCT01919606|B3|Baseline|Total|Total of all reporting groups
114068|NCT01919606|B2|Baseline|EXPAREL Group 2|"EXPAREL 266 mg diluted with saline to a volume of 60 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
114069|NCT01919606|B1|Baseline|EXPAREL Group 1|"EXPAREL 266 mg diluted with saline to a volume of 40 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
114070|NCT01919606|P2|Participant Flow|EXPAREL Group 2|"EXPAREL 266 mg diluted with saline to a volume of 60 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
114071|NCT01919606|P1|Participant Flow|EXPAREL Group 1|"EXPAREL 266 mg diluted with saline to a volume of 40 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
114072|NCT01919606|O2|Outcome|EXPAREL Group 2|"EXPAREL 266 mg diluted with saline to a volume of 60 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
114073|NCT01919606|O1|Outcome|EXPAREL Group 1|"EXPAREL 266 mg diluted with saline to a volume of 40 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
114074|NCT01919606|O2|Outcome|EXPAREL Group 2|"EXPAREL 266 mg diluted with saline to a volume of 60 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
114075|NCT01919606|O1|Outcome|EXPAREL Group 1|"EXPAREL 266 mg diluted with saline to a volume of 40 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
114076|NCT01919606|E2|Reported Event|EXPAREL Group 2|"EXPAREL 266 mg diluted with saline to a volume of 60 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
114077|NCT01919606|E1|Reported Event|EXPAREL Group 1|"EXPAREL 266 mg diluted with saline to a volume of 40 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
114078|NCT01919450|B5|Baseline|Total|Total of all reporting groups
114079|NCT01919450|B4|Baseline|1 Minute Delay|"A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
114080|NCT01919450|B3|Baseline|4 Minute Delay|"A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
114081|NCT01919450|B2|Baseline|2 Minute Delay|"A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
114082|NCT01919450|B1|Baseline|10 Second Delay|"A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
114312|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
114083|NCT01919450|P4|Participant Flow|1 Minute Delay|"A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
114084|NCT01919450|P3|Participant Flow|4 Minute Delay|"A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
114085|NCT01919450|P2|Participant Flow|2 Minute Delay|"A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
114086|NCT01919450|P1|Participant Flow|10 Second Delay|"A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
114087|NCT01919450|O1|Outcome|1 Minute Delay|"A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
114088|NCT01919450|O1|Outcome|10 Second Delay|"A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
114089|NCT01919450|O1|Outcome|2 Minute Delay|"A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
114090|NCT01919450|O1|Outcome|4 Minute Delay|"A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
114091|NCT01919450|E4|Reported Event|1 Minute Delay|"A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
114092|NCT01919450|E3|Reported Event|4 Minute Delay|"A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
114093|NCT01919450|E2|Reported Event|2 Minute Delay|"A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
114094|NCT01919450|E1|Reported Event|10 Second Delay|"A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
114095|NCT01919307|B1|Baseline|Auricular Acupuncture|The NADA Protocol for auricular acupuncture will be performed by the PI, a certified NADA protocol practitioner, using sterile, single-use, Seiren 0.22mm, one cm disposable detox needles. Both ears will be sterilized with alcohol swabs. There will be no electrical or other stimulation performed. Needles will be placed subcutaneously with one half twirl upon insertion to the following 5 points (in order per ear): Sympathetic, Shen Men, Kidney, Liver, Lung. Needles will remain in place for 40 minutes and will then be removed in the same order as they were inserted. Needles that become dislodged will be replaced per typical NADA protocol.
114096|NCT01919307|P1|Participant Flow|Auricular Acupuncture|The NADA Protocol for auricular acupuncture will be performed by the PI, a certified NADA protocol practitioner, using sterile, single-use, Seiren 0.22mm, one cm disposable detox needles. Both ears will be sterilized with alcohol swabs. There will be no electrical or other stimulation performed. Needles will be placed subcutaneously with one half twirl upon insertion to the following 5 points (in order per ear): Sympathetic, Shen Men, Kidney, Liver, Lung. Needles will remain in place for 40 minutes and will then be removed in the same order as they were inserted. Needles that become dislodged will be replaced per typical NADA protocol.
114097|NCT01919307|O1|Outcome|Auricular Acupuncture|The NADA Protocol for auricular acupuncture will be performed by the PI, a certified NADA protocol practitioner, using sterile, single-use, Seiren 0.22mm, one cm disposable detox needles. Both ears will be sterilized with alcohol swabs. There will be no electrical or other stimulation performed. Needles will be placed subcutaneously with one half twirl upon insertion to the following 5 points (in order per ear): Sympathetic, Shen Men, Kidney, Liver, Lung. Needles will remain in place for 40 minutes and will then be removed in the same order as they were inserted. Needles that become dislodged will be replaced per typical NADA protocol.
114098|NCT01919307|O1|Outcome|Auricular Acupuncture|The NADA Protocol for auricular acupuncture will be performed by the PI, a certified NADA protocol practitioner, using sterile, single-use, Seiren 0.22mm, one cm disposable detox needles. Both ears will be sterilized with alcohol swabs. There will be no electrical or other stimulation performed. Needles will be placed subcutaneously with one half twirl upon insertion to the following 5 points (in order per ear): Sympathetic, Shen Men, Kidney, Liver, Lung. Needles will remain in place for 40 minutes and will then be removed in the same order as they were inserted. Needles that become dislodged will be replaced per typical NADA protocol.
114141|NCT01919216|P2|Participant Flow|Placebo Track - Citalopram|"Blinded treatment with either citalopram 20mg, increased to citalopram 40mg at week 4 if depression has not remitted.~Citalopram"
114099|NCT01919307|O1|Outcome|Auricular Acupuncture|The NADA Protocol for auricular acupuncture will be performed by the PI, a certified NADA protocol practitioner, using sterile, single-use, Seiren 0.22mm, one cm disposable detox needles. Both ears will be sterilized with alcohol swabs. There will be no electrical or other stimulation performed. Needles will be placed subcutaneously with one half twirl upon insertion to the following 5 points (in order per ear): Sympathetic, Shen Men, Kidney, Liver, Lung. Needles will remain in place for 40 minutes and will then be removed in the same order as they were inserted. Needles that become dislodged will be replaced per typical NADA protocol.
114100|NCT01919307|O1|Outcome|Auricular Acupuncture|The NADA Protocol for auricular acupuncture will be performed by the PI, a certified NADA protocol practitioner, using sterile, single-use, Seiren 0.22mm, one cm disposable detox needles. Both ears will be sterilized with alcohol swabs. There will be no electrical or other stimulation performed. Needles will be placed subcutaneously with one half twirl upon insertion to the following 5 points (in order per ear): Sympathetic, Shen Men, Kidney, Liver, Lung. Needles will remain in place for 40 minutes and will then be removed in the same order as they were inserted. Needles that become dislodged will be replaced per typical NADA protocol.
114101|NCT01919307|E1|Reported Event|Auricular Acupuncture|The NADA Protocol for auricular acupuncture will be performed by the PI, a certified NADA protocol practitioner, using sterile, single-use, Seiren 0.22mm, one cm disposable detox needles. Both ears will be sterilized with alcohol swabs. There will be no electrical or other stimulation performed. Needles will be placed subcutaneously with one half twirl upon insertion to the following 5 points (in order per ear): Sympathetic, Shen Men, Kidney, Liver, Lung. Needles will remain in place for 40 minutes and will then be removed in the same order as they were inserted. Needles that become dislodged will be replaced per typical NADA protocol.
114102|NCT01919229|B4|Baseline|Total|Total of all reporting groups
114103|NCT01919229|B3|Baseline|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
114104|NCT01919229|B2|Baseline|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
114105|NCT01919229|B1|Baseline|Letrozole|Letrozole 2.5 mg alone once daily
114106|NCT01919229|P3|Participant Flow|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
114107|NCT01919229|P2|Participant Flow|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
114108|NCT01919229|P1|Participant Flow|Letrozole|Letrozole 2.5 mg alone once daily
114109|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
114110|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
114111|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
114112|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
114113|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
114114|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
114115|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
114116|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
114117|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
114118|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
114119|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
114120|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
114121|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
114122|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
114123|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
114124|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
114125|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
114126|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
114127|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
114128|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
114129|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
114130|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
114131|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
114132|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
114133|NCT01919229|E3|Reported Event|LEE600mgqd+Letrozole2.5mgqd|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
114134|NCT01919229|E2|Reported Event|LEE400mgqd+Letrozole2.5mgqd|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
114135|NCT01919229|E1|Reported Event|Letrozole2.5mgqd|Letrozole 2.5 mg alone once daily
114136|NCT01919216|B4|Baseline|Total|Total of all reporting groups
114137|NCT01919216|B3|Baseline|Placebo Track - Placebo|Blinded treatment with placebo
114138|NCT01919216|B2|Baseline|Placebo Track - Citalopram|"Blinded treatment with citalopram 20mg , increased to citalopram 40mg at week 4 if depression has not remitted.~Citalopram"
114139|NCT01919216|B1|Baseline|Open Track|"Open treatment with 20mg of citalopram, increased to 40mg if depression has not remitted at week 4.~Citalopram"
114140|NCT01919216|P3|Participant Flow|Placebo Track - Placebo|Blinded treatment with either placebo
114142|NCT01919216|P1|Participant Flow|Open Track|"Open treatment with 20mg of citalopram, increased to 40mg if depression has not remitted at week 4.~Citalopram"
114144|NCT01919216|O2|Outcome|Placebo Track - Citalopram|"Blinded treatment with either citalopram 20mg, increased to citalopram 40mg or placebo at week 4 if depression has not remitted.~Citalopram"
114145|NCT01919216|O1|Outcome|Open Track|"Open treatment with 20mg of citalopram, increased to 40mg if depression has not remitted at week 4.~Citalopram"
114146|NCT01919216|E3|Reported Event|Placebo Track - Placebo|Blinded treatment with placebo
114147|NCT01919216|E2|Reported Event|Placebo Track - Citalopram|"Blinded treatment with citalopram 20mg, increased to citalopram 40mg or placebo at week 4 if depression has not remitted.~Citalopram"
114148|NCT01919216|E1|Reported Event|Open Track|"Open treatment with 20mg of citalopram, increased to 40mg if depression has not remitted at week 4.~Citalopram"
114149|NCT01918800|B3|Baseline|Total|Total of all reporting groups
114150|NCT01918800|B2|Baseline|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.~MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
114151|NCT01918800|B1|Baseline|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline~Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
114152|NCT01918800|P2|Participant Flow|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.~MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
114153|NCT01918800|P1|Participant Flow|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline~Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
114154|NCT01918800|O2|Outcome|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.~MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
114155|NCT01918800|O1|Outcome|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline~Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
114156|NCT01918800|O2|Outcome|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.~MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
114157|NCT01918800|O1|Outcome|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline~Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
114158|NCT01918800|O2|Outcome|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.~MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
114159|NCT01918800|O1|Outcome|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline~Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
114160|NCT01918800|O2|Outcome|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.~MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
114161|NCT01918800|O1|Outcome|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline~Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
114162|NCT01918800|O2|Outcome|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.~MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
114163|NCT01918800|O1|Outcome|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline~Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
114164|NCT01918800|O2|Outcome|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.~MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
114165|NCT01918800|O1|Outcome|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline~Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
114166|NCT01918800|O2|Outcome|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.~MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
114167|NCT01918800|O1|Outcome|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline~Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
114168|NCT01918800|E2|Reported Event|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.~MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
114169|NCT01918800|E1|Reported Event|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline~Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
114170|NCT01918371|B3|Baseline|Total|Total of all reporting groups
114171|NCT01918371|B2|Baseline|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114172|NCT01918371|B1|Baseline|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114173|NCT01918371|P2|Participant Flow|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114174|NCT01918371|P1|Participant Flow|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114175|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114176|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114177|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114178|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114179|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114180|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114181|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114182|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114183|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114184|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114185|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114186|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114187|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114188|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114189|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114190|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114191|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114192|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114193|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114194|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114195|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114196|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114197|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114198|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114199|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114200|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114201|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114313|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
119478|NCT01890694|O1|Outcome|Tolvaptan|Subjects will receive Tolvaptan once daily.
114202|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114203|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114204|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114205|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114206|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114207|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114208|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114209|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114210|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114211|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114212|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114213|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114214|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114215|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114216|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114217|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114218|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114219|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114220|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114221|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114222|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114223|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114224|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114225|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114226|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114227|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114228|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114314|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
136498|NCT01806857|O2|Outcome|Matching Placebo|
114229|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114230|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114231|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114232|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114233|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114234|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114235|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114236|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114237|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114238|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114239|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114240|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114241|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114242|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114243|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114244|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114245|NCT01918371|E2|Reported Event|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114246|NCT01918371|E1|Reported Event|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
114247|NCT01918332|B5|Baseline|Total|Total of all reporting groups
114248|NCT01918332|B4|Baseline|Placebo|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.~Valsartan 160mg placebo~Rosuvastatin 20mg placebo"
114249|NCT01918332|B3|Baseline|Valsartan 160mg Placebo, Rosuvastatin 20mg|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.~Rosuvastatin 20mg~Valsartan 160mg placebo"
114250|NCT01918332|B2|Baseline|Valsartan 160mg, Rosuvastatin 20mg Placebo|"Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.~Valsartan 160mg~Rosuvastatin 20mg placebo"
114251|NCT01918332|B1|Baseline|Valsartan 160mg, Rosuvastatin 20mg|"Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.~Valsartan 160mg~Rosuvastatin 20mg"
114252|NCT01918332|P4|Participant Flow|Placebo|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.~Valsartan 160mg placebo~Rosuvastatin 20mg placebo"
114253|NCT01918332|P3|Participant Flow|Valsartan 160mg Placebo, Rosuvastatin 20mg|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.~Rosuvastatin 20mg~Valsartan 160mg placebo"
114254|NCT01918332|P2|Participant Flow|Valsartan 160mg, Rosuvastatin 20mg Placebo|"Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.~Valsartan 160mg~Rosuvastatin 20mg placebo"
114255|NCT01918332|P1|Participant Flow|Valsartan 160mg, Rosuvastatin 20mg|"Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.~Valsartan 160mg~Rosuvastatin 20mg"
114256|NCT01918332|O2|Outcome|V160 & Placebo|Valsartan 160mg + Rosuvastatin 20mg placebo & Placebo
114257|NCT01918332|O1|Outcome|V160+R20 & R20|Valsartan 160mg + Rosuvastatin 20mg & Valsartan 160mg placebo + Rosuvastatin 20mg
114258|NCT01918332|O2|Outcome|R20 & Placebo|Valsartan 160mg placebo + Rosuvastatin 20mg & Placebo
114259|NCT01918332|O1|Outcome|V160+R20 & V160|Valsartan 160mg + Rosuvastatin 20mg & Valsartan 160mg + Rosuvastatin 20mg placebo
119479|NCT01890694|O2|Outcome|Tolvaptan|Subjects will receive 15 mg Tolvaptan once daily.
114260|NCT01918332|E4|Reported Event|Placebo|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.~Valsartan 160mg placebo~Rosuvastatin 20mg placebo"
114261|NCT01918332|E3|Reported Event|Valsartan 160mg Placebo, Rosuvastatin 20mg|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.~Rosuvastatin 20mg~Valsartan 160mg placebo"
114262|NCT01918332|E2|Reported Event|Valsartan 160mg, Rosuvastatin 20mg Placebo|"Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.~Valsartan 160mg~Rosuvastatin 20mg placebo"
114263|NCT01918332|E1|Reported Event|Valsartan 160mg, Rosuvastatin 20mg|"Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.~Valsartan 160mg~Rosuvastatin 20mg"
114264|NCT01918306|B3|Baseline|Total|Total of all reporting groups
114265|NCT01918306|B2|Baseline|Cisplatin and GDC-0941|"Patients receive cisplatin as in Arm I and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.~cisplatin: In Arm I patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.~In Arm II patients receive cisplatin as in Arm I and PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~GDC -0941: Patients receive cisplatin as in Arm I and PI3K inhibitor GDC-0941 PO QD on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity"
114266|NCT01918306|B1|Baseline|Cisplatin|"Patients receive cisplatin in Arm I. Patients may crossover to Arm II upon disease progression.~cisplatin: In Arm I patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.~In Arm II patients receive cisplatin as in Arm I and PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
114267|NCT01918306|P4|Participant Flow|2PHII2 - Arm 2 - Cisplatin and GDC-0941|"Patients receive Cisplatin and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.~cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~patients receive PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
114268|NCT01918306|P3|Participant Flow|2PHII1 - Arm 1 - Cisplatin Only|"Patients receive cisplatin in Arm I. Patients may crossover to Arm II upon disease progression.~cisplatin: In Arm I patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
114269|NCT01918306|P2|Participant Flow|1PHIbB - Arm B - Cisplatin + GDC -0941 Dose Level -1|If 2 or more patients in 3 or 6 patients (cohort 1 and 2) treated at a given dose 260 mg experience DLT, the dose will be de-escalated to the next lower dose level.
114270|NCT01918306|P1|Participant Flow|1PHIbA - Arm A - Cisplatin + GDC -0941 Dose Level 1 Cohort 1&2|"Patients receive cisplatin and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.~cisplatin: patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~PI3K inhibitor: GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
114271|NCT01918306|O3|Outcome|2PHIICO - Crossover to Arm 2 - Cistplatin + GDC - 0941|"Crossover patient received Cisplatin and PI3K inhibitor GDC-0941 after found to have disease progression in Cisplatin only arm. Courses repeat in the absence of disease progression or unacceptable toxicity.~cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~patients receive PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
114272|NCT01918306|O2|Outcome|2PHII2 - Arm 2 - Cisplatin and GDC-0941|"Patients receive Cisplatin and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.~cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~patients receive PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
114273|NCT01918306|O1|Outcome|2PHII1 - Arm 1 - Cisplatin|"Patients receive Cisplatin in Arm I. Patients may crossover to Arm II upon disease progression.~Cisplatin: patients received Cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
114315|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
114316|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
119480|NCT01890694|O1|Outcome|Placebo|Subjects will receive placebo once daily.
114274|NCT01918306|O3|Outcome|2PHIICO - Crossover to 2 - Cisplatin + GDC-0941|"Crossover patient received Cisplatin and PI3K inhibitor GDC-0941 after found to have disease progression in Cisplatin only arm. Courses repeat in the absence of disease progression or unacceptable toxicity.~cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~patients receive PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
114275|NCT01918306|O2|Outcome|2PHII2 - ARM 2 - Cisplatin and GDC-0941|"Patients receive Cisplatin and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.~cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~patients receive PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
114276|NCT01918306|O1|Outcome|2 PHII1 - ARM 1 Cisplatin|"Patients receive Cisplatin in Arm I. Patients may crossover to Arm II upon disease progression.~Cisplatin: patients received Cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
114277|NCT01918306|O3|Outcome|1PHIbB - Arm B - Cistplatin + GDC -0941 Dose Level -1|If 2 or more patients in 3 or 6 patients (cohort 1 and 2) treated at a given dose 260 mg experience DLT, the dose will be de-escalated to the next lower dose level.
114278|NCT01918306|O2|Outcome|1 PHIbA - Arm 1 - Cisplatin and GDC-0941Cohort 2|"Starting dose of GDC - 0941 260mg, no DLT's experienced in cohort 1. Therefore no de-escalation of the intensity of the dose was necessary. An additional cohort of 3 patients will be treated at the same dose level beginning at the highest dose level. (Highest dose = 260mg)~In cohort 2, patients received Cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also received PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~≤1 patient has a DLT in 6 treated at this same dose, this will be considered a tolerable dose to move to phase II."
114279|NCT01918306|O1|Outcome|1PHIbA - Cisplatin and GDC-0941 Cohort 1|"Starting dose of GDC - 0941 260mg. De-escalation of the intensity of the dose (if necessary) will proceed among cohorts of 3 patients according to a standard 3+3 algorithm beginning at the highest dose level. (Highest dose = 260mg)~In cohort 1 patients received Cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also received PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
114280|NCT01918306|O3|Outcome|2PHIICO - Crossover to Arm 2 - Cisplatin and GDC-0941|"Crossover patient received Cisplatin and PI3K inhibitor GDC-0941 after found to have disease progression in Cisplatin only arm. Courses repeat in the absence of disease progression or unacceptable toxicity.~cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~patients receive PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
114281|NCT01918306|O2|Outcome|2PHII2 Arm 2 - Cisplatin and GDC-0941|"Patients receive Cisplatin and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.~cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~patients receive PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
114282|NCT01918306|O1|Outcome|2PHII1 Arm 1 Cisplatin|"Patients receive cisplatin in Arm I. Patients may crossover to Arm II upon disease progression.~cisplatin:patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
114283|NCT01918306|O1|Outcome|1PHIbA -Cisplatin and GDC-0941|"Patients receive cisplatin and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.~cisplatin: patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~PI3K inhibitor: GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
114284|NCT01918306|E5|Reported Event|2PHIICO - Crossover to Arm 2 - Cistplatin + GDC -0941|"Crossover patient received Cisplatin and PI3K inhibitor GDC-0941 after found to have disease progression in Cisplatin only arm. Courses repeat in the absence of disease progression or unacceptable toxicity.~cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~patient received PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
114285|NCT01918306|E4|Reported Event|2PHII2 - Arm 2 - Cisplatin and GDC-0941|"Patients receive Cisplatin and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.~cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~patients receive PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies~GDC -0941: Patients receive cisplatin as in Arm I and PI3K"
114286|NCT01918306|E3|Reported Event|2PHII 1 - Arm 1 - Cisplatin Only|"Patients receive cisplatin in Arm I. Patients may crossover to Arm II upon disease progression.~cisplatin:patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies~dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
114287|NCT01918306|E2|Reported Event|1PHIbB - Arm B - Cisplatin + GDC -0941 Dose Level -1|If 2 or more patients in 3 or 6 patients (cohort 1 and 2) treated at a given dose 260 mg experience DLT, the dose will be de-escalated to the next lower dose level.
114288|NCT01918306|E1|Reported Event|1PHIbA - Arm A - Cisplatin + GDC - 0941 Dose Level 1|"Patients cohort 1 receive cisplatin and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.~cisplatin: patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~PI3K inhibitor: GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~If no patients in Cohort 1 experienced DLT's after 4 weeks, all patients in Cohort 2 will receive cisplatin and PI3K inhibitor GDC-0941, GDC-0941dose not to exceed 260mg.~If 1 patient experiences a DLT in the first cohort, an additional cohort of 3 patients will be treated at the same dose level in cohort 2.~If ≤1 patient has a DLT in 6 (cohort 1 and 2) treated at this same dose, this will be considered a tolerable dose to move to phase II."
114289|NCT01918085|B3|Baseline|Total|Total of all reporting groups
114290|NCT01918085|B2|Baseline|Peristomal Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin~Strata strip : An adhesive strip made of the Strata adhesive~Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
114291|NCT01918085|B1|Baseline|Pre-stripped Abdominal Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin~Strata strip : An adhesive strip made of the Strata adhesive~Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
114292|NCT01918085|P2|Participant Flow|First Peristomal Skin, Then Pre-stripped Abdomianl Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin~Strata strip : An adhesive strip made of the Strata adhesive~Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
114293|NCT01918085|P1|Participant Flow|First Pre-stripped Abdominal Skin, Then Peristomal Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin~Strata strip : An adhesive strip made of the Strata adhesive~Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
114294|NCT01918085|O4|Outcome|Peristomal Skin - Hydrocolloid Adhesive|"The peel force used to remove a hydrocolloid strip from the Peristomal skin~hydrocolloid strip : An adhesive strip made of the hydrocolloid adhesive"
114295|NCT01918085|O3|Outcome|Pre-stripped Abdominal Skin - Hydrocolloid Adhesive|"The peel force used to remove a hydrocolloid strip from the Peristomal skin~hydrocolloid strip : An adhesive strip made of the hydrocolloid adhesive"
114296|NCT01918085|O2|Outcome|Pre-stripped Abdominal Skin -Strata Adhesive|"The peel force used to remove a strata strip from healthy abdominal skin~Strata strip : An adhesive strip made of the Strata adhesive"
114297|NCT01918085|O1|Outcome|Peristomal Skin- Strata Adhesive|"The peel force used to remove a strata strip) from the Peristomal skin~Strata strip : An adhesive strip made of the Strata adhesive"
114298|NCT01918085|E2|Reported Event|Peristomal Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin~Strata strip : An adhesive strip made of the Strata adhesive~Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
114299|NCT01918085|E1|Reported Event|Pre-stripped Abdominal Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin~Strata strip : An adhesive strip made of the Strata adhesive~Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
114300|NCT01918033|B4|Baseline|Total|Total of all reporting groups
114301|NCT01918033|B3|Baseline|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
114302|NCT01918033|B2|Baseline|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
114303|NCT01918033|B1|Baseline|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
114304|NCT01918033|P3|Participant Flow|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
114305|NCT01918033|P2|Participant Flow|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
114306|NCT01918033|P1|Participant Flow|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
114307|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
114308|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
114309|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
114310|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
114311|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
114317|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
114318|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
114319|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
114320|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
114321|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
114322|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
114323|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
114324|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
114325|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
114326|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
114327|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
114328|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
114329|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
114330|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
114331|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
114332|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
114333|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
114334|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
114335|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
114336|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
114337|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
114338|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
114339|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
114340|NCT01918033|E3|Reported Event|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
114341|NCT01918033|E2|Reported Event|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
114342|NCT01918033|E1|Reported Event|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
114343|NCT01917812|B4|Baseline|Total|Total of all reporting groups
114344|NCT01917812|B3|Baseline|Unblinded Digital Activity Tracker / Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.~Smart Text Messaging = Group receives personalized, health coaching via smart text messages.~Unblinded Digital Activity Tracker~Smart Text Messaging"
114345|NCT01917812|B2|Baseline|Unblinded Digital Activity Tracker / No Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.~Unblinded Digital Activity Tracker"
114346|NCT01917812|B1|Baseline|Blinded Digital Activity Tracker|"Blinded Digital Activity Tracker = Group wears the tracker but is blinded to the numeric physical activity feedback information provided by the tracker.~Blinded Digital Activity Tracker"
114347|NCT01917812|P3|Participant Flow|Unblinded Digital Activity Tracker / Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.~Smart Text Messaging = Group receives personalized, health coaching via smart text messages.~Unblinded Digital Activity Tracker~Smart Text Messaging"
114348|NCT01917812|P2|Participant Flow|Unblinded Digital Activity Tracker / No Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.~No Smart Text Messaging = Group does not receive personalized, health coaching via smart text messages.~Unblinded Digital Activity Tracker"
114349|NCT01917812|P1|Participant Flow|Blinded Digital Activity Tracker|"Blinded Digital Activity Tracker = Group wears the tracker but is blinded to the numeric physical activity feedback information provided by the tracker.~Blinded Digital Activity Tracker"
114350|NCT01917812|O3|Outcome|Unblinded Digital Activity Tracker / Smart Text Messaging|
114351|NCT01917812|O2|Outcome|Unblinded Digital Activity Tracker|
114352|NCT01917812|O1|Outcome|Blinded Digital Activity Tracker|
114353|NCT01917812|O3|Outcome|Unblinded Digital Activity Tracker / Smart Text Messaging|
114354|NCT01917812|O2|Outcome|Unblinded Digital Activity Tracker|
114355|NCT01917812|O1|Outcome|Blinded Digital Activity Tracker|
114356|NCT01917812|O3|Outcome|Unblinded Digital Activity Tracker / Smart Text Messaging|
114357|NCT01917812|O2|Outcome|Unblinded Digital Activity Tracker|
114358|NCT01917812|O1|Outcome|Blinded Digital Activity Tracker|
114359|NCT01917812|O2|Outcome|Unblinded Digital Activity Tracker|
114360|NCT01917812|O1|Outcome|Blinded Digital Activity Tracker|
114361|NCT01917812|O2|Outcome|Unblinded Digital Activity Tracker|
114362|NCT01917812|O1|Outcome|Blinded Digital Activity Tracker|
114363|NCT01917812|O2|Outcome|Unblinded Digital Activity Tracker|
114364|NCT01917812|O1|Outcome|Blinded Digital Activity Tracker|
114400|NCT01917656|E1|Reported Event|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
114401|NCT01917526|B3|Baseline|Total|Total of all reporting groups
114365|NCT01917812|E3|Reported Event|Unblinded Digital Activity Tracker / Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.~Smart Text Messaging = Group receives personalized, health coaching via smart text messages.~Unblinded Digital Activity Tracker~Smart Text Messaging"
114366|NCT01917812|E2|Reported Event|Unblinded Digital Activity Tracker / No Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.~Unblinded Digital Activity Tracker"
114367|NCT01917812|E1|Reported Event|Blinded Digital Activity Tracker|"Blinded Digital Activity Tracker = Group wears the tracker but is blinded to the numeric physical activity feedback information provided by the tracker.~Blinded Digital Activity Tracker"
114368|NCT01917773|B1|Baseline|Octreotide|"Fasting motility was recorded for at least 60 minutes.~Octreotide 1mcg/kg, maximum of 50mcg was administered subcutaneously (one hour after application of EMLA topical cream). Motility was then recorded for 45-60 minutes.~Patients were then offered a high-fat, high-energy meal as described elsewhere, and motility was recorded for 60 minutes.~Patients then received 1 to 2 doses of bisacodyl (0.2 mg/kg, maximum of 10 mg) through the motility catheter, and motility was recorded."
114369|NCT01917773|P1|Participant Flow|Octreotide|This was a non-randomized, single center, open label, and prospective study. Thirteen patients were enrolled in the study. All patient received Octreotide as per study protocol.
114370|NCT01917773|O3|Outcome|45 Minutes|The MI for the 45 minutes before and after octreotide infusion was measured.
114371|NCT01917773|O2|Outcome|30 Minutes|The MI for the 30 minutes before and after octreotide infusion was measured.
114372|NCT01917773|O1|Outcome|15 Minutes|The MI for the 15 minutes before and after octreotide infusion was measured.
114373|NCT01917773|E1|Reported Event|All Patients|All 13 patient received octreotide injection. Motility Index (MI) (mm Hg) for the 15 minutes before and after octreotide infusion was measured.
114374|NCT01917656|B3|Baseline|Total|Total of all reporting groups
114375|NCT01917656|B2|Baseline|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
114376|NCT01917656|B1|Baseline|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
114377|NCT01917656|P2|Participant Flow|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
114378|NCT01917656|P1|Participant Flow|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
114379|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
114380|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
114381|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
114382|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
114383|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
114384|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
114385|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
114386|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
114387|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
114388|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
114389|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
114390|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
114391|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
114392|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
114393|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
114394|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
114395|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
114396|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
114397|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
114398|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
114399|NCT01917656|E2|Reported Event|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
136499|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
114402|NCT01917526|B2|Baseline|Oxygen Cannula|"Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen cannula"
114403|NCT01917526|B1|Baseline|Oxygen Mask|"Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen mask"
114404|NCT01917526|P2|Participant Flow|Oxygen Cannula|"Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen cannula"
114405|NCT01917526|P1|Participant Flow|Oxygen Mask|"Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen mask"
114406|NCT01917526|O2|Outcome|Oxygen Cannula|"Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen cannula"
114407|NCT01917526|O1|Outcome|Oxygen Mask|"Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen mask"
114408|NCT01917526|O2|Outcome|Oxygen Cannula|"Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen cannula"
114409|NCT01917526|O1|Outcome|Oxygen Mask|"Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen mask"
114410|NCT01917526|E2|Reported Event|Oxygen Cannula|"Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen cannula"
114411|NCT01917526|E1|Reported Event|Oxygen Mask|"Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen mask"
114412|NCT01917513|B3|Baseline|Total|Total of all reporting groups
114413|NCT01917513|B2|Baseline|G-EYE™ Colonoscopy|Patients in this group underwent G-EYE™ high definition colonoscopy using using an insufflated balloon during withdrawal
114414|NCT01917513|B1|Baseline|Standard Colonoscopy|Patients in this group underwent standard high definition colonoscopy
114415|NCT01917513|P2|Participant Flow|G-EYE™ Colonoscopy|Patients in this group underwent G-EYE™ high definition colonoscopy using using an insufflated balloon during withdrawal
114416|NCT01917513|P1|Participant Flow|Standard Colonoscopy|Patients in this group underwent standard high definition colonoscopy
114417|NCT01917513|O2|Outcome|G-EYE™ Colonoscopy|Patients in this group underwent G-EYE™ high definition colonoscopy using using an insufflated balloon during withdrawal
114418|NCT01917513|O1|Outcome|Standard Colonoscopy|Patients in this group underwent standard high definition colonoscopy
114419|NCT01917513|E2|Reported Event|Standard Colonoscopy|"Standard Colonoscopy~Standard Colonoscopy: Standard Colonoscopy"
114420|NCT01917513|E1|Reported Event|G-EYE™ Colonoscopy|"G-EYE™ colonoscopy~G-EYE™ colonoscopy: G-EYE™ colonoscopy"
114421|NCT01917344|B1|Baseline|Adults With PKU|"MRI, EEG, neuropsychological testing, neurological examination, blood draw, diet diary, physical examination~MRI"
114422|NCT01917344|P1|Participant Flow|Adults With PKU|"MRI, EEG, neuropsychological testing, neurological examination, blood draw, diet diary, physical examination~MRI"
114423|NCT01917344|O1|Outcome|Adults With PKU|"MRI, EEG, neuropsychological testing, neurological examination, blood draw, diet diary, physical examination~MRI"
114424|NCT01917344|E1|Reported Event|Adults With PKU|"MRI, EEG, neuropsychological testing, neurological examination, blood draw, diet diary, physical examination~MRI"
114425|NCT01917214|B1|Baseline|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who received either systemic therapy (Sutent [sunitinib malate] 25 milligram [mg], 37.5 mg or 50 mg or other systemic drugs [like bevacizumab, everolimus, pazopanib, sorafenib, temsirolimus]) OR best supportive care (BSC) as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
114426|NCT01917214|P1|Participant Flow|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who received either systemic therapy (Sutent [sunitinib malate] 25 milligram [mg], 37.5 mg or 50 mg or other systemic drugs [like bevacizumab, everolimus, pazopanib, sorafenib, temsirolimus]) OR best supportive care (BSC) as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
114427|NCT01917214|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy|Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
114428|NCT01917214|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy|Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
114429|NCT01917214|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy|Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
114430|NCT01917214|O1|Outcome|mRCC Cohort: Sutent Therapy and BSC|Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg OR best supportive care (BSC) as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
114431|NCT01917214|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy|Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
114432|NCT01917214|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy|Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
114485|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
114486|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
114433|NCT01917214|E1|Reported Event|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who received either systemic therapy (Sutent [sunitinib malate] 25 milligram [mg], 37.5 mg or 50 mg or other systemic drugs [like bevacizumab, everolimus, pazopanib, sorafenib, temsirolimus]) OR best supportive care (BSC) as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
114434|NCT01916980|B3|Baseline|Total|Total of all reporting groups
114435|NCT01916980|B2|Baseline|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
114436|NCT01916980|B1|Baseline|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
114437|NCT01916980|P2|Participant Flow|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
114438|NCT01916980|P1|Participant Flow|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
114439|NCT01916980|O2|Outcome|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
114440|NCT01916980|O1|Outcome|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
114441|NCT01916980|O2|Outcome|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
114442|NCT01916980|O1|Outcome|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
114443|NCT01916980|O2|Outcome|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
114444|NCT01916980|O1|Outcome|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
114445|NCT01916980|O2|Outcome|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
114446|NCT01916980|O1|Outcome|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
114447|NCT01916980|O2|Outcome|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
114448|NCT01916980|O1|Outcome|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
114487|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
114700|NCT01915849|O1|Outcome|LIK066 15 mg|All patients who have received LIK066 15 mg once daily for 4 days.
114449|NCT01916980|O2|Outcome|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
114450|NCT01916980|O1|Outcome|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
114451|NCT01916980|E2|Reported Event|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
114452|NCT01916980|E1|Reported Event|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
114453|NCT01916967|B4|Baseline|Total|Total of all reporting groups
114454|NCT01916967|B3|Baseline|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
114455|NCT01916967|B2|Baseline|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
114456|NCT01916967|B1|Baseline|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
114457|NCT01916967|P3|Participant Flow|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
114458|NCT01916967|P2|Participant Flow|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
114459|NCT01916967|P1|Participant Flow|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
114460|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
114461|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
114462|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
114463|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
114464|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
114465|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
114466|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
114467|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
114468|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
114469|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
114470|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
114471|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
114472|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
114473|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
114474|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
114475|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
114476|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
114477|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
114478|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
114479|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
114480|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
114481|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
114482|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
114483|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
114484|NCT01916967|O4|Outcome|Desloratadine 5 mg→Placebo|Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
114701|NCT01915849|E4|Reported Event|LIK066 150 mg|LIK066 150 mg
114488|NCT01916967|O4|Outcome|Desloratadine 5 mg→Placebo|Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
114489|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
114490|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
114491|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
114492|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
114493|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
114494|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
114495|NCT01916967|E4|Reported Event|Desloratadine 5 mg→Placebo|Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
114496|NCT01916967|E3|Reported Event|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
114497|NCT01916967|E2|Reported Event|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
114498|NCT01916967|E1|Reported Event|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
114499|NCT01916941|B3|Baseline|Total|Total of all reporting groups
114500|NCT01916941|B2|Baseline|Placebo|"Placebo X 6 weeks~Placebo"
114501|NCT01916941|B1|Baseline|Prazosin|"Prazosin titrated to 16 mg daily x 6 weeks~Prazosin"
114502|NCT01916941|P2|Participant Flow|Placebo|"Placebo X 6 weeks~Placebo"
114503|NCT01916941|P1|Participant Flow|Prazosin|"Prazosin titrated to 16 mg daily x 6 weeks~Prazosin"
114504|NCT01916941|O2|Outcome|Placebo|"Placebo X 6 weeks~Placebo"
114505|NCT01916941|O1|Outcome|Prazosin|"Prazosin titrated to 16 mg daily x 6 weeks~Prazosin"
114506|NCT01916941|E2|Reported Event|Placebo|"Placebo X 6 weeks~Placebo"
114507|NCT01916941|E1|Reported Event|Prazosin|"Prazosin titrated to 16 mg daily x 6 weeks~Prazosin"
114508|NCT01916928|B1|Baseline|Non-viable Pregnancy|Women presenting with stillbirth, defined as fetal death occurring after 20 weeks gestation or with miscarriage, defined as fetal death prior to 20 weeks gestation.
114509|NCT01916928|P1|Participant Flow|Non-viable Pregnancy|Women presenting with stillbirth, defined as fetal death occurring after 20 weeks gestation or with miscarriage, defined as fetal death prior to 20 weeks gestation.
114510|NCT01916928|O1|Outcome|Non-viable Pregnancy|Women presenting with stillbirth, defined as fetal death occurring after 20 weeks gestation or with miscarriage, defined as fetal death prior to 20 weeks gestation.
114511|NCT01916928|E1|Reported Event|Non-viable Pregnancy|Women presenting with stillbirth, defined as fetal death occurring after 20 weeks gestation or with miscarriage, defined as fetal death prior to 20 weeks gestation.
114512|NCT01916824|B3|Baseline|Total|Total of all reporting groups
114513|NCT01916824|B2|Baseline|Healthy Controls|Persons without a history of Major Depressive Disorder and without a current diagnosis of any mental illness
114514|NCT01916824|B1|Baseline|Participants With Major Depressive Disorder|Persons with a primary diagnosis of Major Depressive Disorder who start taking any FDA-approved antidepressant prescribed within standard dose range for 6 weeks
114515|NCT01916824|P2|Participant Flow|Healthy Controls|Persons without a history of Major Depressive Disorder and without a current diagnosis of any mental illness
114516|NCT01916824|P1|Participant Flow|Participants With Major Depressive Disorder|Persons with a primary diagnosis of Major Depressive Disorder who start taking any FDA-approved antidepressant prescribed within standard dose range for 6 weeks
114517|NCT01916824|O2|Outcome|Healthy Controls|Persons without a history of Major Depressive Disorder and without a current diagnosis of any mental illness
114518|NCT01916824|O1|Outcome|Participants With Major Depressive Disorder|Persons with a primary diagnosis of Major Depressive Disorder who start taking any FDA-approved antidepressant prescribed within standard dose range for 6 weeks
114519|NCT01916824|E2|Reported Event|Healthy Controls|Persons without a history of Major Depressive Disorder and without a current diagnosis of any mental illness
114520|NCT01916824|E1|Reported Event|Participants With Major Depressive Disorder|Persons with a primary diagnosis of Major Depressive Disorder who start taking any FDA-approved antidepressant prescribed within standard dose range for 6 weeks
114521|NCT01916681|B5|Baseline|Total|Total of all reporting groups
114522|NCT01916681|B4|Baseline|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Pitocin: A cervical foley combined with pitocin will be used to induce the patient"
114523|NCT01916681|B3|Baseline|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
114524|NCT01916681|B2|Baseline|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
114525|NCT01916681|B1|Baseline|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
114526|NCT01916681|P4|Participant Flow|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
114527|NCT01916681|P3|Participant Flow|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
114528|NCT01916681|P2|Participant Flow|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
114529|NCT01916681|P1|Participant Flow|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
114530|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
114531|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
114532|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
114533|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
114534|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
114535|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
114536|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
114537|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
114538|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
114539|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
114540|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
114541|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
114542|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
114543|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
114544|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
114545|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
114546|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
114547|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
114548|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
114549|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
114550|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
114551|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
114552|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
114553|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
114554|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
114555|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
114556|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
114557|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
114558|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Pitocin: A cervical foley combined with pitocin will be used to induce the patient"
114619|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
114559|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
114560|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
114561|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
114562|NCT01916681|E4|Reported Event|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
114563|NCT01916681|E3|Reported Event|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
114564|NCT01916681|E2|Reported Event|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
114565|NCT01916681|E1|Reported Event|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
114566|NCT01916629|B3|Baseline|Total|Total of all reporting groups
114567|NCT01916629|B2|Baseline|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
114568|NCT01916629|B1|Baseline|Photocil for Psoriasis|"Active Drug - Photocil for Psoriasis~Photocil for Psoriasis: Photocil for Psoriasis"
114569|NCT01916629|P2|Participant Flow|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
114570|NCT01916629|P1|Participant Flow|Photocil for Psoriasis|"Active Drug - Photocil for Psoriasis~Photocil for Psoriasis: Photocil for Psoriasis"
114571|NCT01916629|O2|Outcome|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
114572|NCT01916629|O1|Outcome|Photocil for Psoriasis|"Active Drug - Photocil for Psoriasis~Photocil for Psoriasis: Photocil for Psoriasis"
114573|NCT01916629|E2|Reported Event|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
114574|NCT01916629|E1|Reported Event|Photocil for Psoriasis|"Active Drug - Photocil for Psoriasis~Photocil for Psoriasis: Photocil for Psoriasis"
114575|NCT01916590|B3|Baseline|Total|Total of all reporting groups
114576|NCT01916590|B2|Baseline|Placebo|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine) through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with saline solution, and the infusion will be started at 6 ml/hr. gh the catheter.~placebo"
114577|NCT01916590|B1|Baseline|Bupivacaine|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine)through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter.~Bupivicaine: After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter."
114578|NCT01916590|P2|Participant Flow|Placebo|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine) through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with saline solution, and the infusion will be started at 6 ml/hr. gh the catheter.~placebo"
114579|NCT01916590|P1|Participant Flow|Bupivacaine|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine)through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter.~Bupivicaine: After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter."
114580|NCT01916590|O2|Outcome|Placebo|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine) through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with saline solution, and the infusion will be started at 6 ml/hr. gh the catheter.~placebo"
114581|NCT01916590|O1|Outcome|Bupivacaine|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine)through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter.~Bupivicaine: After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter."
114582|NCT01916590|E2|Reported Event|Placebo|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine) through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with saline solution, and the infusion will be started at 6 ml/hr. gh the catheter.~placebo"
114620|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
114621|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
114702|NCT01915849|E3|Reported Event|LIK066 50 mg|LIK066 50 mg
114703|NCT01915849|E2|Reported Event|LIK066 15 mg|LIK066 15 mg
114583|NCT01916590|E1|Reported Event|Bupivacaine|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine)through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter.~Bupivicaine: After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter."
114584|NCT01916304|B1|Baseline|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
114585|NCT01916304|P1|Participant Flow|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
114586|NCT01916304|O1|Outcome|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
114587|NCT01916304|O1|Outcome|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
114588|NCT01916304|O1|Outcome|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
114589|NCT01916304|O1|Outcome|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
114590|NCT01916304|O1|Outcome|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
114591|NCT01916304|E1|Reported Event|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
114592|NCT01916226|B5|Baseline|Total|Total of all reporting groups
114593|NCT01916226|B4|Baseline|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
114594|NCT01916226|B3|Baseline|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
114595|NCT01916226|B2|Baseline|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
114596|NCT01916226|B1|Baseline|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
114597|NCT01916226|P4|Participant Flow|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
114598|NCT01916226|P3|Participant Flow|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
114599|NCT01916226|P2|Participant Flow|Cetirizine 10 mg|Participants self-administered a 10 milligram (mg) cetrizine capsule once daily in the AM for 2 weeks.
114600|NCT01916226|P1|Participant Flow|FPNS 200 μg|Participants self-administered fluticasone propionate nasal spray (FPNS) 200 micrograms (µg) per day as two sprays in each nostril (50 μg per spray) once daily in the morning (AM) for 2 weeks.
114601|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
114602|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
114603|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
114604|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
114605|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
114606|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
114607|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
114608|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
114609|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
114610|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
114611|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
114612|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
114613|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
114614|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
114615|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
114616|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
114617|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
114618|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
114622|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
114623|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
114624|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
114625|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
114626|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
114627|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
114628|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks
114629|NCT01916226|E4|Reported Event|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
114630|NCT01916226|E3|Reported Event|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
114631|NCT01916226|E2|Reported Event|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
114632|NCT01916226|E1|Reported Event|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
114633|NCT01916109|B1|Baseline|Gemcitabine, Carboplatin, and Panitumumab (GCaP)|Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
114634|NCT01916109|P1|Participant Flow|Gemcitabine, Carboplatin, and Panitumumab (GCaP)|Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
114635|NCT01916109|O1|Outcome|Gemcitabine, Carboplatin, and Panitumumab (GCaP)|Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
114636|NCT01916109|E1|Reported Event|Gemcitabine, Carboplatin, and Panitumumab (GCaP)|Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
114637|NCT01915940|B3|Baseline|Total|Total of all reporting groups
114638|NCT01915940|B2|Baseline|Timolol 0.5% + Placebo Ocular Insert|Following the washout period, timolol ophthalmic solution 0.5% twice a day plus placebo ocular insert in each eye for 6 months.
114639|NCT01915940|B1|Baseline|13 mg Bimatoprost Ocular Insert|Following the washout period, 13 mg Bimatoprost Ocular Insert and placebo eye drops twice a day in each eye for 6 months.
114640|NCT01915940|P3|Participant Flow|Timolol 0.5% + Placebo Ocular Insert|Following the washout period, timolol ophthalmic solution 0.5% twice a day plus placebo ocular insert in each eye for 6 months.
114641|NCT01915940|P2|Participant Flow|13 mg Bimatoprost Ocular Insert|Following the washout period, 13 mg Bimatoprost Ocular Insert and placebo eye drops twice a day in each eye for 6 months.
114642|NCT01915940|P1|Participant Flow|Washout + Placebo Ocular Insert|Glaucoma medication washout and placebo ocular insert in each eye for at least 4 weeks.
114643|NCT01915940|O2|Outcome|Timolol 0.5% + Placebo Ocular Insert|Following the washout period, timolol ophthalmic solution 0.5% twice a day plus placebo ocular insert in each eye for 6 months.
114644|NCT01915940|O1|Outcome|13 mg Bimatoprost Ocular Insert|Following the washout period, 13 mg Bimatoprost Ocular Insert and placebo eye drops twice a day in each eye for 6 months.
114645|NCT01915940|O2|Outcome|Timolol 0.5% + Placebo Ocular Insert|Following the washout period, timolol ophthalmic solution 0.5% twice a day plus placebo ocular insert in each eye for 6 months.
114646|NCT01915940|O1|Outcome|13 mg Bimatoprost Ocular Insert|Following the washout period, 13 mg Bimatoprost Ocular Insert and placebo eye drops twice a day in each eye for 6 months.
114647|NCT01915940|O2|Outcome|Timolol 0.5% + Placebo Ocular Insert|Following the washout period, timolol ophthalmic solution 0.5% twice a day plus placebo ocular insert in each eye for 6 months.
114648|NCT01915940|O1|Outcome|13 mg Bimatoprost Ocular Insert|Following the washout period, 13 mg Bimatoprost Ocular Insert and placebo eye drops twice a day in each eye for 6 months.
114649|NCT01915940|O2|Outcome|Timolol 0.5% + Placebo Ocular Insert|Following the washout period, timolol ophthalmic solution 0.5% twice a day plus placebo ocular insert in each eye for 6 months.
114650|NCT01915940|O1|Outcome|13 mg Bimatoprost Ocular Insert|Following the washout period, 13 mg Bimatoprost Ocular Insert and placebo eye drops twice a day in each eye for 6 months.
114651|NCT01915940|O2|Outcome|Timolol 0.5% + Placebo Ocular Insert|Following the washout period, timolol ophthalmic solution 0.5% twice a day plus placebo ocular insert in each eye for 6 months.
114652|NCT01915940|O1|Outcome|13 mg Bimatoprost Ocular Insert|Following the washout period, 13 mg Bimatoprost Ocular Insert and placebo eye drops twice a day in each eye for 6 months.
114653|NCT01915940|O2|Outcome|Timolol 0.5% + Placebo Ocular Insert|Following the washout period, timolol ophthalmic solution 0.5% twice a day plus placebo ocular insert in each eye for 6 months.
114654|NCT01915940|O1|Outcome|13 mg Bimatoprost Ocular Insert|Following the washout period, 13 mg Bimatoprost Ocular Insert and placebo eye drops twice a day in each eye for 6 months.
114655|NCT01915940|E2|Reported Event|Timolol 0.5% + Placebo Ocular Insert|Following the washout period, timolol ophthalmic solution 0.5% twice a day plus placebo ocular insert in each eye for 6 months.
114656|NCT01915940|E1|Reported Event|13 mg Bimatoprost Ocular Insert|Following the washout period, 13 mg Bimatoprost Ocular Insert and placebo eye drops twice a day in each eye for 6 months.
114694|NCT01915849|P3|Participant Flow|Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg|Period 1- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 3- Placebo treatment once daily for 4 days. Period 4- LIK066 15 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
114704|NCT01915849|E1|Reported Event|Placebo|Placebo
114705|NCT01915823|B3|Baseline|Total|Total of all reporting groups
119481|NCT01890694|E2|Reported Event|Tolvaptan|Subjects will receive 15 mg Tolvaptan once daily.
114657|NCT01915914|B1|Baseline|Overall|Participants who entered the Acute Phase received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to the affected sites and any newly occurring atopic dermatitis (AD) sites. The efficacy and safety in the Acute Phase assessed every 2 weeks up to 4 weeks or until treatment success. Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with physician static global assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, participants received emollient BID plus FP 0.05% cream OD twice a week, or emollient BID, up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase in either treatment group without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
114658|NCT01915914|P4|Participant Flow|Follow-up: Emollient|Participants who completed the study treatment in the Maintenance Phase in either treatment group without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
114659|NCT01915914|P3|Participant Flow|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
114660|NCT01915914|P2|Participant Flow|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.
114661|NCT01915914|P1|Participant Flow|FP 0.05% Cream|Participants who satisfied eligibility criteria received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to affected sites and any newly occurring atopic dermatitis (AD) sites. Investigator assessed Eczema Area, AD Severity, Visual Skin Assessment, and conducted physical examination, vital sign measurement in the Acute Phase. The efficacy and safety in the Acute Phase was assessed every 2 weeks up to 4 weeks or until treatment success.
114662|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks to the affected and unaffected areas.
114663|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a weekup to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
114664|NCT01915914|O1|Outcome|FP 0.05% Cream|Participants who satisfied eligibility criteria received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to affected sites and any newly occurring atopic dermatitis (AD) sites. Investigator assessed Eczema Area, AD Severity, Visual Skin Assessment, and conducted physical examination, vital sign measurement in the Acute Phase. The efficacy and safety in the Acute Phase was assessed every 2 weeks up to 4 weeks or until treatment success.
114665|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks to the affected and unaffected areas.
114666|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a weekup to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
114667|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks to the affected and unaffected areas.
114695|NCT01915849|P2|Participant Flow|Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo|Period 1- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 4- Placebo treatment once daily for 4 days. 14 days washout periods between treatment periods.
114706|NCT01915823|B2|Baseline|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily~Dymista vehicle"
114668|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a weekup to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
114669|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks to the affected and unaffected areas.
114670|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a weekup to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
114671|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe).During the Maintenance Phase, the participants received emollient BID up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
114672|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a week, up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
114673|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID, up to 20 weeks.
114674|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.
114675|NCT01915914|O1|Outcome|FP 0.05% Cream|Participants who satisfied eligibility criteria received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to affected sites and any newly occurring atopic dermatitis (AD) sites. Investigator assessed Eczema Area, AD Severity, Visual Skin Assessment, and conducted physical examination, vital sign measurement in the Acute Phase. The efficacy and safety in the Acute Phase was assessed every 2 weeks up to 4 weeks or until treatment success.
114676|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID, up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
114677|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
114678|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID, up to 20 weeks.
114696|NCT01915849|P1|Participant Flow|Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg|Period 1- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 2- Placebo treatment once daily for 4 days. Period 3 - LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 150 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
114679|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.
114680|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID, up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
114681|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
114682|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
114683|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.
114684|NCT01915914|E4|Reported Event|Follow-up: Emollient|Participants who completed the study treatment in the Maintenance Phase in either treatment group without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
114685|NCT01915914|E3|Reported Event|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA less than or equal to 1; and the improvement greater than or equal to 2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
114686|NCT01915914|E2|Reported Event|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) less than or equal to 1; and the improvement greater than or equal to 2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.
114687|NCT01915914|E1|Reported Event|FP 0.05% Cream|Participants who satisfied eligibility criteria received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to affected sites and any newly occurring atopic dermatitis (AD) sites. Investigator assessed Eczema Area, AD Severity, Visual Skin Assessment, and conducted physical examination, vital sign measurement in the Acute Phase. The efficacy and safety of FP 0.05% cream was assessed every 2 weeks up to 4 weeks or until treatment success.
114688|NCT01915849|B5|Baseline|Total|Total of all reporting groups
114689|NCT01915849|B4|Baseline|Sequence 4: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg|Period 1- Placebo treatment once daily (q.d.) for 4 days. Period 2- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 50 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
114690|NCT01915849|B3|Baseline|Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg|Period 1- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 3- Placebo treatment once daily for 4 days. Period 4- LIK066 15 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
114691|NCT01915849|B2|Baseline|Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo|Period 1- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 4- Placebo treatment once daily for 4 days. 14 days washout periods between treatment periods.
114692|NCT01915849|B1|Baseline|Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg|Period 1- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 2- Placebo treatment once daily for 4 days. Period 3 - LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 150 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
114693|NCT01915849|P4|Participant Flow|Sequence 4: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg|Period 1- Placebo treatment once daily (q.d.) for 4 days. Period 2- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 50 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
114697|NCT01915849|O4|Outcome|Placebo|All patients who have received placebo once daily for 4 days.
114698|NCT01915849|O3|Outcome|LIK066 150 mg|All patients who have received LIK066 150 mg once daily for 4 days.
136500|NCT01806857|O2|Outcome|Matching Placebo|
114707|NCT01915823|B1|Baseline|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray~Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily~azelastine hydrochloride and fluticasone propionate"
114708|NCT01915823|P2|Participant Flow|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily~Dymista vehicle"
114709|NCT01915823|P1|Participant Flow|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray~Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily~azelastine hydrochloride and fluticasone propionate"
114710|NCT01915823|O2|Outcome|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily~Dymista vehicle"
114711|NCT01915823|O1|Outcome|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray~Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily~azelastine hydrochloride and fluticasone propionate"
114712|NCT01915823|O2|Outcome|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily~Dymista vehicle"
114713|NCT01915823|O1|Outcome|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray~Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily~azelastine hydrochloride and fluticasone propionate"
114714|NCT01915823|O2|Outcome|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily~Dymista vehicle"
114715|NCT01915823|O1|Outcome|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray~Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily~azelastine hydrochloride and fluticasone propionate"
114716|NCT01915823|E2|Reported Event|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily~Dymista vehicle"
114717|NCT01915823|E1|Reported Event|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray~Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily~azelastine hydrochloride and fluticasone propionate"
114718|NCT01915732|B3|Baseline|Total|Total of all reporting groups
114719|NCT01915732|B2|Baseline|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
114720|NCT01915732|B1|Baseline|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
114721|NCT01915732|P2|Participant Flow|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
114722|NCT01915732|P1|Participant Flow|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
114723|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
114724|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
114725|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
114726|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
114727|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
114728|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
114729|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
114730|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
114731|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
114732|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
114733|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
114734|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
114735|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
114736|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
114804|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
114737|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
114738|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
114739|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
114740|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
114741|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
114742|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
114743|NCT01915732|E2|Reported Event|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
114744|NCT01915732|E1|Reported Event|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
114745|NCT01915173|B5|Baseline|Total|Total of all reporting groups
114746|NCT01915173|B4|Baseline|Supplement + Expanded Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Expanded Interview"
114747|NCT01915173|B3|Baseline|Placebo + Expanded Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Expanded Interview"
114748|NCT01915173|B2|Baseline|Supplement + Standard Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Standard Interview"
114749|NCT01915173|B1|Baseline|Placebo + Standard Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Standard Interview"
114750|NCT01915173|P4|Participant Flow|Placebo + Expanded Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Expanded Interview"
114751|NCT01915173|P3|Participant Flow|Supplement + Standard Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Standard Interview"
114752|NCT01915173|P2|Participant Flow|Placebo + Standard Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Standard Interview"
114753|NCT01915173|P1|Participant Flow|Supplement + Expanded Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Expanded Interview"
114754|NCT01915173|O4|Outcome|Supplement + Expanded Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Expanded Interview"
114755|NCT01915173|O3|Outcome|Placebo + Expanded Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Expanded Interview"
114756|NCT01915173|O2|Outcome|Supplement + Standard Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Standard Interview"
114757|NCT01915173|O1|Outcome|Placebo + Standard Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Standard Interview"
114758|NCT01915173|O4|Outcome|Supplement + Expanded Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Expanded Interview"
114759|NCT01915173|O3|Outcome|Placebo + Expanded Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Expanded Interview"
114760|NCT01915173|O2|Outcome|Supplement + Standard Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Standard Interview"
114761|NCT01915173|O1|Outcome|Placebo + Standard Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Standard Interview"
114762|NCT01915173|O4|Outcome|Supplement + Expanded Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Expanded Interview"
114763|NCT01915173|O3|Outcome|Placebo + Expanded Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Expanded Interview"
114764|NCT01915173|O2|Outcome|Supplement + Standard Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Standard Interview"
114765|NCT01915173|O1|Outcome|Placebo + Standard Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Standard Interview"
114766|NCT01915173|E4|Reported Event|Supplement + Expanded Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Expanded Interview"
114767|NCT01915173|E3|Reported Event|Placebo + Expanded Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Expanded Interview"
114768|NCT01915173|E2|Reported Event|Supplement + Standard Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Standard Interview"
114769|NCT01915173|E1|Reported Event|Placebo + Standard Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Standard Interview"
114770|NCT01915108|B5|Baseline|Total|Total of all reporting groups
114805|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
114771|NCT01915108|B4|Baseline|Group R1.5|"remifentanil Ce of 1.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
114772|NCT01915108|B3|Baseline|Group R1.0|"remifentanil Ce of 1.0 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
114773|NCT01915108|B2|Baseline|Group R0.5|"remifentanil Ce of 0.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
114774|NCT01915108|B1|Baseline|Group R0|remifentanil Ce of 0 ng/ml
114775|NCT01915108|P4|Participant Flow|Group R1.5|"remifentanil Ce of 1.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
114776|NCT01915108|P3|Participant Flow|Group R1.0|"remifentanil Ce of 1.0 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
114777|NCT01915108|P2|Participant Flow|Group R0.5|"remifentanil Ce of 0.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
114778|NCT01915108|P1|Participant Flow|Group R0|remifentanil Ce of 0 ng/ml
114779|NCT01915108|O4|Outcome|Group R1.5|"remifentanil Ce of 1.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
114780|NCT01915108|O3|Outcome|Group R1.0|"remifentanil Ce of 1.0 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
114781|NCT01915108|O2|Outcome|Group R0.5|"remifentanil Ce of 0.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
114782|NCT01915108|O1|Outcome|Group R0|remifentanil Ce of 0 ng/ml
114783|NCT01915108|E4|Reported Event|Group R1.0|"remifentanil Ce of 1.0 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
114784|NCT01915108|E3|Reported Event|Group R0.5|"remifentanil Ce of 0.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
114785|NCT01915108|E2|Reported Event|Group R1.5|"remifentanil Ce of 1.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
114786|NCT01915108|E1|Reported Event|Group R0|"remifentanil Ce of 0 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
114787|NCT01914926|B3|Baseline|Total|Total of all reporting groups
114788|NCT01914926|B2|Baseline|Diltiazem Study Group|Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
114789|NCT01914926|B1|Baseline|Metoprolol Study Group|Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)
114790|NCT01914926|P2|Participant Flow|Diltiazem Study Group|Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
114791|NCT01914926|P1|Participant Flow|Metoprolol Study Group|Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)
114792|NCT01914926|O2|Outcome|Diltiazem Study Group|Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
114793|NCT01914926|O1|Outcome|Metoprolol Study Group|Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)
114794|NCT01914926|E2|Reported Event|Diltiazem Study Group|Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
114795|NCT01914926|E1|Reported Event|Metoprolol Study Group|Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)
114796|NCT01914757|B4|Baseline|Total|Total of all reporting groups
114797|NCT01914757|B3|Baseline|Placebo|Placebo administered subcutaneously
114798|NCT01914757|B2|Baseline|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
114799|NCT01914757|B1|Baseline|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
114800|NCT01914757|P3|Participant Flow|Placebo|Placebo administered subcutaneously
114801|NCT01914757|P2|Participant Flow|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
114802|NCT01914757|P1|Participant Flow|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
114803|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
114806|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
114807|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
114808|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
114809|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
114810|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
114811|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
114812|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
114813|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
114814|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
114815|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
114816|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
114817|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
114818|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
114819|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
114820|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
114821|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
114822|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
114823|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
114824|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
114825|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
114826|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
114827|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
114828|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
114829|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
114830|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
114831|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
114832|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
114833|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
114834|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
114835|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
114836|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
114837|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
114838|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
114839|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
114840|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
114841|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
114842|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
114843|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
114844|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
114845|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
114846|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
114847|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
114848|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
114849|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
114850|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
114851|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
114852|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
114853|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
114854|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
114855|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
114856|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
114857|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
114858|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
114859|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
114860|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
114861|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
114862|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
114863|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
114864|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
114865|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
114866|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
114867|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
114868|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
114869|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
114870|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
114871|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
114872|NCT01914757|E3|Reported Event|Placebo|Placebo administered subcutaneously
114873|NCT01914757|E2|Reported Event|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
114874|NCT01914757|E1|Reported Event|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
114875|NCT01914679|B1|Baseline|Sham and RINCE Treatment|"4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy (8 treatments) and 12 weeks of RINCE therapy (24 treatments).~RINCE: The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal."
114876|NCT01914679|P1|Participant Flow|Sham and RINCE Treatment|"4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy (8 treatments), and 12 weeks of RINCE therapy (24 treatments).~RINCE: The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal."
114877|NCT01914679|O1|Outcome|Sham and RINCE Treatment|"4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy (8 treatments) and 12 weeks of RINCE therapy (24 treatments).~RINCE: The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal."
114878|NCT01914679|E1|Reported Event|Sham and RINCE Treatment|"4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy (8 treatments) and 12 weeks of RINCE therapy (24 treatments).~RINCE: The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal."
114879|NCT01914666|B4|Baseline|Total|Total of all reporting groups
114880|NCT01914666|B3|Baseline|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114881|NCT01914666|B2|Baseline|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114882|NCT01914666|B1|Baseline|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114883|NCT01914666|P3|Participant Flow|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114884|NCT01914666|P2|Participant Flow|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY [NCT#01855919]) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114885|NCT01914666|P1|Participant Flow|Naïve|New participants (Pts) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114886|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114887|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114888|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114889|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114890|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114891|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114892|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114893|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114894|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114895|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114896|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114897|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114898|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114899|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
115073|NCT01913405|O1|Outcome|Full Analysis Group|All participants treated with BAX855 with at least one available hemostatic assessment.
114900|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114901|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114902|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114903|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114904|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114905|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114906|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114907|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114908|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114909|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114910|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114911|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114912|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114913|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114914|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114915|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
114916|NCT01914666|E1|Reported Event|Naïve, Rollover (Pre-Placebo), Rollover (Pre-Duloxetine 60 mg)|All participants from Naïve, Rollover (Pre-Placebo), Rollover (Pre-Duloxetine 60 mg) groups combined.
114917|NCT01914003|B3|Baseline|Total|Total of all reporting groups
114918|NCT01914003|B2|Baseline|Control|Individual does not have any known CSID mutations.
114919|NCT01914003|B1|Baseline|CSID Mutations|Individual has one or more known CSID mutations.
114920|NCT01914003|P2|Participant Flow|Control|Individual does not have any known CSID mutations.
114921|NCT01914003|P1|Participant Flow|CSID Mutations|Individual has one or more known CSID mutations.
114922|NCT01914003|O2|Outcome|Control|Individual does not have any known CSID mutations.
114923|NCT01914003|O1|Outcome|CSID Mutations|Individual has one or more known CSID mutations.
114924|NCT01914003|E2|Reported Event|Control|Individual does not have any known CSID mutations.
114925|NCT01914003|E1|Reported Event|CSID Mutations|Individual has one or more known CSID mutations.
114926|NCT01913795|B5|Baseline|Total|Total of all reporting groups
114927|NCT01913795|B4|Baseline|Sham and IPM|"classroom sham air purifiers and school integrated pest management~integrated pest management: integrated pest management and environmental strategy"
114928|NCT01913795|B3|Baseline|Air Purifier and no IPM|"air purifiers and no school integrated pest management environmental intervention~air purifier: air purifiers"
114929|NCT01913795|B2|Baseline|Sham and no IPM|sham air purifiers and no school integrated pest management environmental intervention
114930|NCT01913795|B1|Baseline|Air Purifier + IPM|"classroom air purifiers and school integrated pest management environmental intervention~integrated pest management: integrated pest management and environmental strategy~air purifier: air purifiers"
114931|NCT01913795|P4|Participant Flow|Sham and IPM|"classroom sham air purifiers and school integrated pest management~integrated pest management: integrated pest management and environmental strategy"
114932|NCT01913795|P3|Participant Flow|Air Purifier and no IPM|"air purifiers and no school integrated pest management environmental intervention~air purifier: air purifiers"
114933|NCT01913795|P2|Participant Flow|Sham and no IPM|sham air purifiers and no school integrated pest management environmental intervention
114934|NCT01913795|P1|Participant Flow|Air Purifier + IPM|"classroom air purifiers and school integrated pest management environmental intervention~integrated pest management: integrated pest management and environmental strategy~air purifier: air purifiers"
114935|NCT01913795|O4|Outcome|Sham and IPM|"5 subjects~classroom sham air purifiers and school integrated pest management~integrated pest management: integrated pest management and environmental strategy"
136501|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
114936|NCT01913795|O3|Outcome|Air Purifier and no IPM|"9 subjects~air purifiers and no school integrated pest management environmental intervention~air purifier: air purifiers"
114937|NCT01913795|O2|Outcome|Sham and no IPM|"7 subjects~sham air purifiers and no school integrated pest management environmental intervention"
114938|NCT01913795|O1|Outcome|Air Purifier + IPM|"4 subjects~classroom air purifiers and school integrated pest management environmental intervention~integrated pest management: integrated pest management and environmental strategy~air purifier: air purifiers"
114939|NCT01913795|O4|Outcome|Sham and IPM|"5 subjects~classroom sham air purifiers and school integrated pest management~integrated pest management: integrated pest management and environmental strategy"
114940|NCT01913795|O3|Outcome|Air Purifier and no IPM|"9 subjects~air purifiers and no school integrated pest management environmental intervention~air purifier: air purifiers"
114941|NCT01913795|O2|Outcome|Sham and no IPM|"7 subjects~sham air purifiers and no school integrated pest management environmental intervention"
114942|NCT01913795|O1|Outcome|Air Purifier + IPM|"4 subjects~classroom air purifiers and school integrated pest management environmental intervention~integrated pest management: integrated pest management and environmental strategy~air purifier: air purifiers"
114943|NCT01913795|O4|Outcome|Sham and IPM|"5 subjects~classroom sham air purifiers and school integrated pest management~integrated pest management: integrated pest management and environmental strategy"
114944|NCT01913795|O3|Outcome|Air Purifier and no IPM|"9 subjects~air purifiers and no school integrated pest management environmental intervention~air purifier: air purifiers"
114945|NCT01913795|O2|Outcome|Sham and no IPM|"7 subjects~sham air purifiers and no school integrated pest management environmental intervention"
114946|NCT01913795|O1|Outcome|Air Purifier + IPM|"4 subjects~classroom air purifiers and school integrated pest management environmental intervention~integrated pest management: integrated pest management and environmental strategy~air purifier: air purifiers"
114947|NCT01913795|E4|Reported Event|Sham and IPM|"classroom sham air purifiers and school integrated pest management~integrated pest management: integrated pest management and environmental strategy"
114948|NCT01913795|E3|Reported Event|Air Purifier and no IPM|"air purifiers and no school integrated pest management environmental intervention~air purifier: air purifiers"
114949|NCT01913795|E2|Reported Event|Sham and no IPM|sham air purifiers and no school integrated pest management environmental intervention
114950|NCT01913795|E1|Reported Event|Air Purifier + IPM|"classroom air purifiers and school integrated pest management environmental intervention~integrated pest management: integrated pest management and environmental strategy~air purifier: air purifiers"
114951|NCT01913600|B1|Baseline|Resolute Integrity US Extended Length Sub-Study (RI-US XL)|"Resolute Integrity Stent~Resolute Integrity Stent: Drug eluting stent (DES)~Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure."
114952|NCT01913600|P1|Participant Flow|Resolute Integrity US Extended Length Sub-Study (RI-US XL)|"Resolute Integrity Stent~Resolute Integrity Stent: Drug eluting stent (DES)~Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure."
114953|NCT01913600|O1|Outcome|Resolute Integrity US Extended Length Sub-Study (RI-US XL)|"Resolute Integrity Stent~Resolute Integrity Stent: Drug eluting stent (DES)~Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure."
114954|NCT01913600|O1|Outcome|Resolute Integrity US Extended Length Sub-Study (RI-US XL)|"Resolute Integrity Stent~Resolute Integrity Stent: Drug eluting stent (DES)~Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure."
114955|NCT01913600|O1|Outcome|Resolute Integrity US Extended Length Sub-Study (RI-US XL)|"Resolute Integrity Stent~Resolute Integrity Stent: Drug eluting stent (DES)~Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure."
114956|NCT01913600|O1|Outcome|Resolute Integrity US Extended Length Sub-Study (RI-US XL)|"Resolute Integrity Stent~Resolute Integrity Stent: Drug eluting stent (DES)~Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure."
114957|NCT01913600|O1|Outcome|Resolute Integrity US Extended Length Sub-Study (RI-US XL)|"Resolute Integrity Stent~Resolute Integrity Stent: Drug eluting stent (DES)~Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure."
114975|NCT01913535|P4|Participant Flow|Placebo/High-Dose Drug Arm|"Patients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 20.0 mg/day for 3 days (in Phase 2)~CERC-501: High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days)."
115074|NCT01913405|O4|Outcome|Minor Surgery|All participants treated with BAX855 for minor surgery.
114958|NCT01913600|O1|Outcome|Resolute Integrity US Extended Length Sub-Study (RI-US XL)|"Resolute Integrity Stent~Resolute Integrity Stent: Drug eluting stent (DES)~Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure."
114959|NCT01913600|O1|Outcome|Resolute Integrity US Extended Length Sub-Study (RI-US XL)|"Resolute Integrity Stent~Resolute Integrity Stent: Drug eluting stent (DES)~Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure."
114960|NCT01913600|O1|Outcome|Resolute Integrity US Extended Length Sub-Study (RI-US XL)|"Resolute Integrity Stent~Resolute Integrity Stent: Drug eluting stent (DES)~Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure."
114961|NCT01913600|O1|Outcome|Resolute Integrity US Extended Length Sub-Study (RI-US XL)|"Resolute Integrity Stent~Resolute Integrity Stent: Drug eluting stent (DES)~Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure."
114962|NCT01913600|O1|Outcome|Resolute Integrity US Extended Length Sub-Study (RI-US XL)|"Resolute Integrity Stent~Resolute Integrity Stent: Drug eluting stent (DES)~Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure."
114963|NCT01913600|O1|Outcome|Resolute Integrity US Extended Length Sub-Study (RI-US XL)|"Resolute Integrity Stent~Resolute Integrity Stent: Drug eluting stent (DES)~Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure."
114964|NCT01913600|O1|Outcome|Resolute Integrity US Extended Length Sub-Study (RI-US XL)|"Resolute Integrity Stent~Resolute Integrity Stent: Drug eluting stent (DES)~Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure."
114965|NCT01913600|O1|Outcome|Resolute Integrity US Extended Length Sub-Study (RI-US XL)|"Resolute Integrity Stent~Resolute Integrity Stent: Drug eluting stent (DES)~Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure."
114966|NCT01913600|O1|Outcome|Resolute Integrity US Extended Length Sub-Study (RI-US XL)|"Resolute Integrity Stent~Resolute Integrity Stent: Drug eluting stent (DES)~Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure."
114967|NCT01913600|E1|Reported Event|Resolute Integrity US Extended Length Sub-Study (RI-US XL)|"Resolute Integrity Stent~Resolute Integrity Stent: Drug eluting stent (DES)~Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure."
114968|NCT01913535|B6|Baseline|Total|Total of all reporting groups
114969|NCT01913535|B5|Baseline|Placebo/Placebo Arm|Patients in this arm will receive placebo for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)
114970|NCT01913535|B4|Baseline|Placebo/High-Dose Drug Arm|"Patients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 20.0 mg/day for 3 days (in Phase 2)~CERC-501: High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days)."
114971|NCT01913535|B3|Baseline|Placebo/Low-Dose Drug Arm|"Patients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 10.0 mg/day for 3 days (in Phase 2)~CERC-501: Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days)."
114972|NCT01913535|B2|Baseline|High Dose Drug-Drug Arm|"Patients in this arm will receive CERC-501 20.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)~CERC-501: High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days)."
114973|NCT01913535|B1|Baseline|Low Dose Drug-Drug Arm|"Patients in this arm will receive CERC-501 10.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)~CERC-501: Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days)."
114974|NCT01913535|P5|Participant Flow|Placebo/Placebo Arm|"Patients in this arm will receive placebo for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)~Placebo: For patients randomly assigned to the placebo/ placebo sequence, study medication will be placebo during the first phase (3 days) and during the second phase (3 days)."
114976|NCT01913535|P3|Participant Flow|Placebo/Low-Dose Drug Arm|"Patients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 10.0 mg/day for 3 days (in Phase 2)~CERC-501: Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days).~For patients randomly assigned to the placebo/low-dose drug sequence, the patient will receive placebo for 3 days and then 10 mg/day CERC-501 for the following 3 days."
114977|NCT01913535|P2|Participant Flow|High Dose Drug-Drug Arm|"Patients in this arm will receive CERC-501 20.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)~CERC-501: High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days)."
114978|NCT01913535|P1|Participant Flow|Low Dose Drug-Drug Arm|"Patients in this arm will receive CERC-501 10.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)~CERC-501: Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days)."
114979|NCT01913535|O2|Outcome|Placebo|"Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3."
114980|NCT01913535|O1|Outcome|CERC-501|"either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1.~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3."
114981|NCT01913535|O2|Outcome|Placebo|"Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3."
114982|NCT01913535|O1|Outcome|CERC-501|"either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1.~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3."
114983|NCT01913535|O2|Outcome|Placebo|"For time frame through 72 hours: Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3."
114984|NCT01913535|O1|Outcome|CERC-501|"For time frame through 72 hours: either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3."
114985|NCT01913535|O2|Outcome|Placebo|"For time frame through 72 hours: Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.~For 20-day time frame: placebo-placebo arm only"
114986|NCT01913535|O1|Outcome|CERC-501|"For time frame through 72 hours: either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.~For 20-day time frame: either dose drug-drug arms only"
114987|NCT01913535|O2|Outcome|Placebo|"For time frame through 72 hours: Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.~For 20-day time frame: placebo-placebo arm only"
114988|NCT01913535|O1|Outcome|CERC-501|"For time frame through 72 hours: either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.~For 20-day time frame: either dose drug-drug arms only"
114989|NCT01913535|O2|Outcome|Placebo|"For time frame through 72 hours: Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.~For 20-day time frame: placebo-placebo arm only"
114990|NCT01913535|O1|Outcome|CERC-501|"For time frame through 72 hours: either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.~For 20-day time frame: either dose drug-drug arms only"
114991|NCT01913535|O2|Outcome|Placebo|"For time frame through 72 hours: Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.~For 20-day time frame: placebo-placebo arm only"
115013|NCT01913483|O2|Outcome|Unfractionated Heparin|UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 U/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
115075|NCT01913405|O3|Outcome|Major Non-orthopedic Surgery|All participants treated with BAX855 for major non-orthopedic surgery.
114992|NCT01913535|O1|Outcome|CERC-501|"For time frame through 72 hours: either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.~For 20-day time frame: either dose drug-drug arms only"
114993|NCT01913535|O2|Outcome|Placebo|"For time frame through 72 hours: Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.~For 20-day time frame: placebo-placebo arm only"
114994|NCT01913535|O1|Outcome|CERC-501|"For time frame through 72 hours: either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.~For 20-day time frame: either dose drug-drug arms only"
114995|NCT01913535|O2|Outcome|Placebo|"For time frame through 72 hours: Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.~For 20-day time frame: placebo-placebo arm only"
114996|NCT01913535|O1|Outcome|CERC-501|"For time frame through 72 hours: either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.~For 20-day time frame: either dose drug-drug arms only"
114997|NCT01913535|O2|Outcome|Placebo|"For time frame through 72 hours: Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.~For 20-day time frame: placebo-placebo arm only"
114998|NCT01913535|O1|Outcome|CERC-501|"For time frame through 72 hours: either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.~For 20-day time frame: either dose drug-drug arms only"
114999|NCT01913535|O2|Outcome|Placebo|"Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3."
115000|NCT01913535|O1|Outcome|CERC-501|"either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1.~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3."
115001|NCT01913535|O2|Outcome|Placebo|Placebo therapy in placebo-placebo arm
115002|NCT01913535|O1|Outcome|CERC-501|either dose (10 mg/day or 20 mg/day) of CERC-501 in drug-drug arms
115003|NCT01913535|O2|Outcome|Placebo|"Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3."
115004|NCT01913535|O1|Outcome|CERC-501|"either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1.~Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3."
115005|NCT01913535|E3|Reported Event|Placebo|Patients receive placebo
115006|NCT01913535|E2|Reported Event|High Dose Drug|Patients receive CERC-501 20.0 mg/day
115007|NCT01913535|E1|Reported Event|Low Dose Drug|Patients receive CERC-501 10.0 mg/day
115008|NCT01913483|B3|Baseline|Total|Total of all reporting groups
115009|NCT01913483|B2|Baseline|Unfractionated Heparin|UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 U/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
115010|NCT01913483|B1|Baseline|Bivalirudin|Bivalirudin was administered as an IV bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 mg/kg) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/h (or 1 mg/kg/h for participants with an eGFR <30 mL/min).
115011|NCT01913483|P2|Participant Flow|Unfractionated Heparin|Unfractionated heparin (UFH) was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 units (U)/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
115012|NCT01913483|P1|Participant Flow|Bivalirudin|Bivalirudin was administered as an intravenous (IV) bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 milligrams (mg)/kilogram [kg]) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/hour (h) (or 1 mg/kg/h for participants with an estimated glomerular filtration rate [eGFR] <30 milliliters per minute [mL/min]).
115072|NCT01913405|O2|Outcome|Major Orthopedic Surgery|All participants treated with BAX855 for major orthopedic surgery.
119482|NCT01890694|E1|Reported Event|Placebo|Subjects will receive placebo once daily.
115014|NCT01913483|O1|Outcome|Bivalirudin|Bivalirudin was administered as an IV bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 mg/kg) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/h (or 1 mg/kg/h for participants with an eGFR <30 mL/min).
115015|NCT01913483|O2|Outcome|Unfractionated Heparin|UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 U/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
115016|NCT01913483|O1|Outcome|Bivalirudin|Bivalirudin was administered as an IV bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 mg/kg) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/h (or 1 mg/kg/h for participants with an eGFR <30 mL/min).
115017|NCT01913483|O2|Outcome|Unfractionated Heparin|UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 U/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
115018|NCT01913483|O1|Outcome|Bivalirudin|Bivalirudin was administered as an IV bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 mg/kg) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/h (or 1 mg/kg/h for participants with an eGFR <30 mL/min).
115019|NCT01913483|E2|Reported Event|Unfractionated Heparin|UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 units (U)/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
115020|NCT01913483|E1|Reported Event|Bivalirudin|Bivalirudin was administered as an IV bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 mg/kg) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/h (or 1 mg/kg/h for participants with an eGFR <30 mL/min).
115021|NCT01913470|B3|Baseline|Total|Total of all reporting groups
115022|NCT01913470|B2|Baseline|Placebo Followed by Losartan|Recipients of treatment with a placebo for 8 weeks followed by 8 weeks of treatment with losartan.
115023|NCT01913470|B1|Baseline|Losartan Followed by Placebo|Recipients of treatment with losartan for 8 weeks followed by 8 weeks of treatment with a placebo.
115024|NCT01913470|P2|Participant Flow|Placebo Followed by Losartan|Recipients of treatment with a placebo for 8 weeks followed by 8 weeks of treatment with losartan.
115025|NCT01913470|P1|Participant Flow|Losartan Followed by Placebo|Recipients of treatment with losartan for 8 weeks followed by 8 weeks of treatment with a placebo
115026|NCT01913470|O2|Outcome|Placebo|Recipients of treatment with a placebo for 8 weeks.
115027|NCT01913470|O1|Outcome|Losartan|Recipients of treatment with losartan for 8 weeks.
115028|NCT01913470|O2|Outcome|Placebo|Recipients of treatment with a placebo for 8 weeks.
115029|NCT01913470|O1|Outcome|Losartan|Recipients of treatment with losartan for 8 weeks.
115030|NCT01913470|O2|Outcome|Placebo|Recipients of treatment with a placebo for 8 weeks.
115031|NCT01913470|O1|Outcome|Losartan|Recipients of treatment with losartan for 8 weeks.
115032|NCT01913470|O2|Outcome|Placebo|Recipients of treatment with a placebo for 8 weeks.
115033|NCT01913470|O1|Outcome|Losartan|Recipients of treatment with losartan for 8 weeks.
115034|NCT01913470|O2|Outcome|Placebo|Recipients of treatment with a placebo for 8 weeks.
115035|NCT01913470|O1|Outcome|Losartan|Recipients of treatment with losartan for 8 weeks.
115036|NCT01913470|O2|Outcome|Placebo|Recipients of treatment with a placebo for 8 weeks
115037|NCT01913470|O1|Outcome|Losartan|Recipients of treatment with losartan for 8 weeks.
115038|NCT01913470|O2|Outcome|Placebo|Recipients of treatment with a placebo for 8 weeks.
115039|NCT01913470|O1|Outcome|Losartan|Recipients of treatment with losartan for 8 weeks.
115040|NCT01913470|E2|Reported Event|Placebo|Recipients of treatment with a placebo for 8 weeks.
115041|NCT01913470|E1|Reported Event|Losartan|Recipients of treatment with losartan for 8 weeks.
115042|NCT01913405|B1|Baseline|BAX855|"Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant’s individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level.~Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed."
115043|NCT01913405|P1|Participant Flow|BAX855|"Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant’s individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level.~Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed."
115044|NCT01913405|O5|Outcome|ALT: Normal at Screening - Abnormal cs at EOS|Chemistry: The ALT result was normal at the screening assessment and changed to abnormal clinically significant at the end of study assessment.
115045|NCT01913405|O4|Outcome|Eosinophils/Leucocytes: Normal at Screening Abnormal cs at EOS|Hematology: The Eosinophils/Leucocytes result was normal at the screening assessment and changed to abnormal clinically significant at the end of study assessment.
115046|NCT01913405|O3|Outcome|Erythrocytes: Normal at Screening - Abnormal cs at EOS|Hematology: The Erythrocytes result was normal at the screening assessment and changed to abnormal clinically significant at the end of study assessment.
115047|NCT01913405|O2|Outcome|Hematocrit: Abnormal Ncs at Screening - Abnormal cs at EOS|Hematology: The hematocrit result was abnormal not clinically significant at the screening assessment and changed to abnormal clinically significant at the end of study assessment.
115048|NCT01913405|O1|Outcome|Hemoglobin: Abnormal Ncs at Screening - Abnormal cs at EOS|Hematology: The hemoglobin result was abnormal not clinically significant at the screening assessment and changed to abnormal clinically significant at the end of study assessment.
115049|NCT01913405|O1|Outcome|BAX855|"Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant’s individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level.~Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed."
115050|NCT01913405|O1|Outcome|BAX855|"Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant’s individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level.~Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed."
115051|NCT01913405|O1|Outcome|BAX855|"Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant’s individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level.~Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed."
115052|NCT01913405|O1|Outcome|BAX855|"Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant’s individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level.~Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed."
115053|NCT01913405|O1|Outcome|BAX855|"Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant’s individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level.~Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed."
115054|NCT01913405|O1|Outcome|BAX855|"Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant’s individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level.~Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed."
115055|NCT01913405|O1|Outcome|BAX855|"Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant’s individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level.~Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed."
115056|NCT01913405|O1|Outcome|BAX855|"Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant’s individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level.~Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed."
115057|NCT01913405|O1|Outcome|BAX855|"Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant’s individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level.~Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed."
115058|NCT01913405|O1|Outcome|BAX855|"Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant’s individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level.~Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed."
115059|NCT01913405|O1|Outcome|Pharmacokinetic Analysis Group|All participants who underwent a pharmacokinetic assessment with BAX855 infusion.
115060|NCT01913405|O1|Outcome|Pharmacokinetic Analysis Group|All participants who underwent a pharmacokinetic assessment with BAX855 infusion.
115061|NCT01913405|O1|Outcome|Pharmacokinetic Analysis Group|All participants who underwent a pharmacokinetic assessment with BAX855 infusion.
115062|NCT01913405|O1|Outcome|Pharmacokinetic Analysis Group|All participants who underwent a pharmacokinetic assessment with BAX855 infusion.
115063|NCT01913405|O1|Outcome|Pharmacokinetic Analysis Group|All participants who underwent a pharmacokinetic assessment with BAX855 infusion.
115064|NCT01913405|O1|Outcome|Pharmocokinetic Analysis Group|All participants who underwent a pharmacokinetic assessment with BAX855 infusion.
115065|NCT01913405|O1|Outcome|Pharmacokinetic Analysis Group|All participants who underwent a pharmacokinetic assessment with BAX855 infusion.
115066|NCT01913405|O4|Outcome|Minor Surgery|All participants treated with BAX855 for minor surgery.
115067|NCT01913405|O3|Outcome|Major Non-orthopedic Surgery|All participants treated with BAX855 for major non-orthopedic surgery.
115068|NCT01913405|O2|Outcome|Major Orthopedic Surgery|All participants treated with BAX855 for major orthopedic surgery.
115069|NCT01913405|O1|Outcome|Full Analysis Group|All participants treated with BAX855 with at least one available hemostatic assessment.
115070|NCT01913405|O4|Outcome|Minor Surgery|All participants treated with BAX855 for minor surgery.
115071|NCT01913405|O3|Outcome|Major Non-orthopedic Surgery|All participants treated with BAX855 for major non-orthopedic surgery.
115076|NCT01913405|O2|Outcome|Major Orthopedic Surgery|All participants treated with BAX855 for major orthopedic surgery.
115077|NCT01913405|O1|Outcome|Full Analysis Group|All participants treated with BAX855 with at least one available hemostatic assessment.
115078|NCT01913405|O4|Outcome|Minor Surgery|All participants treated with BAX855 for minor surgery.
115079|NCT01913405|O3|Outcome|Major Non-orthopedic Surgery|All participants treated with BAX855 for major non-orthopedic surgery.
115080|NCT01913405|O2|Outcome|Major Orthopedic Surgery|All participants treated with BAX855 for major orthopedic surgery.
115081|NCT01913405|O1|Outcome|Full Analysis Group|All participants treated with BAX855 with at least one available hemostatic assessment.
115082|NCT01913405|O4|Outcome|Minor Surgery|All participants treated with BAX855 for minor surgery.
115083|NCT01913405|O3|Outcome|Major Non-orthopedic Surgery|All participants treated with BAX855 for major non-orthopedic surgery.
115084|NCT01913405|O2|Outcome|Major Orthopedic Surgery|All participants treated with BAX855 for major orthopedic surgery.
115085|NCT01913405|O1|Outcome|Full Analysis Group|All participants treated with BAX855 with at least one available hemostatic assessment.
115086|NCT01913405|O4|Outcome|Minor Surgery|All participants treated with BAX855 for minor surgery.
115087|NCT01913405|O3|Outcome|Major Non-orthopedic Surgery|All participants treated with BAX855 for major non-orthopedic surgery.
115088|NCT01913405|O2|Outcome|Major Orthopedic Surgery|All participants treated with BAX855 for major orthopedic surgery.
115089|NCT01913405|O1|Outcome|Full Analysis Group|All participants treated with BAX855 with at least one available hemostatic assessment.
115090|NCT01913405|O5|Outcome|Per Protocol Analysis Group|All participants treated with BAX855 with all 3 hemostatic efficacy assessments available. Only subjects who met all study entry criteria and who had no major protocol violation that impacted hemostatic efficacy assessment were included in this group.
115091|NCT01913405|O4|Outcome|Minor Surgery|All participants treated with BAX855 for minor surgery.
115092|NCT01913405|O3|Outcome|Major Non-orthopedic Surgery|All participants treated with BAX855 for major non-orthopedic surgery.
115093|NCT01913405|O2|Outcome|Major Orthopedic Surgery|All participants treated with BAX855 for major orthopedic surgery.
115094|NCT01913405|O1|Outcome|Full Analysis Group|All participants treated with BAX855 with available GHEA score.
115095|NCT01913405|E1|Reported Event|BAX855|"Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant’s individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level.~Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed."
115096|NCT01913041|B1|Baseline|Investigation Group|This is an epidemiology study in which all the data from the subjects enrolled will be collected and analysis to investigate the current patient warming condition and actual perioperative hyperthermia rate in the elective operation with general anesthesia. During the whole procedure none intervention is administered
115097|NCT01913041|P1|Participant Flow|Investigation Group|This is an epidemiology study in which all the data from the subjects enrolled will be collected and analysis to investigate the current patient warming condition and actual perioperative hyperthermia rate in the elective operation with general anesthesia. During the whole procedure none intervention is administered
115098|NCT01913041|O1|Outcome|Investigation Group|This is an epidemiology study in which all the data from the subjects enrolled will be collected and analysis to investigate the current patient warming condition and actual perioperative hyperthermia rate in the elective operation with general anesthesia. During the whole procedure none intervention is administered
115099|NCT01913041|E1|Reported Event|Observation Group|There is only one group, The main purpose of this investigation is to observe the hypothermia rate in elective operations under general anaesthesia in Peking in China.
115100|NCT01912781|B3|Baseline|Total|Total of all reporting groups
115101|NCT01912781|B2|Baseline|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115102|NCT01912781|B1|Baseline|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115103|NCT01912781|P2|Participant Flow|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115104|NCT01912781|P1|Participant Flow|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115105|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115106|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115107|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115108|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115109|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115110|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115111|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115112|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115113|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115114|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115115|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115116|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115117|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115118|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115119|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115120|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115121|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115122|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115123|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115124|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115125|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115126|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115127|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115128|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
115129|NCT01912781|E3|Reported Event|Boston Simplus|All subjects who were exposed to Boston Simplus
115130|NCT01912781|E2|Reported Event|FID 120974A|All subjects who were exposed to FID 120947A
115131|NCT01912781|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to exposure to investigational product
115132|NCT01912768|B3|Baseline|Total|Total of all reporting groups
115133|NCT01912768|B2|Baseline|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115134|NCT01912768|B1|Baseline|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115135|NCT01912768|P2|Participant Flow|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115136|NCT01912768|P1|Participant Flow|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115137|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115138|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115139|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115140|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115141|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115142|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115143|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115144|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115145|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115146|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115147|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115148|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115149|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115150|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115151|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115152|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115153|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115154|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115155|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115156|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115157|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115158|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115159|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115160|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
115161|NCT01912768|E3|Reported Event|Renu Fresh|All subjects who were exposed to renu fresh
115162|NCT01912768|E2|Reported Event|FID 120947A|All subjects who were exposed to FID 120947A
115163|NCT01912768|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to exposure to investigational product
115164|NCT01912599|B3|Baseline|Total|Total of all reporting groups
115165|NCT01912599|B2|Baseline|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
115166|NCT01912599|B1|Baseline|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
115167|NCT01912599|P2|Participant Flow|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
115168|NCT01912599|P1|Participant Flow|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
115169|NCT01912599|O2|Outcome|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
115170|NCT01912599|O1|Outcome|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
115171|NCT01912599|O2|Outcome|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
115228|NCT01912222|P1|Participant Flow|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
115229|NCT01912222|O3|Outcome|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
115258|NCT01911845|O2|Outcome|Methadone|Participants were on a stable opioid replacement therapy of methadone during the Treatment Period, and for at least six months prior to screening.
115172|NCT01912599|O1|Outcome|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
115173|NCT01912599|O2|Outcome|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
115174|NCT01912599|O1|Outcome|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
115175|NCT01912599|O2|Outcome|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
115176|NCT01912599|O1|Outcome|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
115177|NCT01912599|O2|Outcome|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
115178|NCT01912599|O1|Outcome|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
115209|NCT01912339|P1|Participant Flow|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.~Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
115179|NCT01912599|E2|Reported Event|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
115180|NCT01912599|E1|Reported Event|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
115181|NCT01912495|B1|Baseline|Boceprevir/Peginterferon/Ribavirin|Boceprevir with Peginterferon and Ribavirin
115182|NCT01912495|P1|Participant Flow|Boceprevir|12 week Boceprevir, Peginterferon and Ribavirin in RVR4 group
115183|NCT01912495|O1|Outcome|Boceprevir, Peginterferon and Ribavirin|12 week boceprevir, peginterferon and ribavirin in intention to treat group
115184|NCT01912495|O1|Outcome|Boceprevir Peginterferon Ribavirin|Boceprevir peginterferon and ribavirin
115185|NCT01912495|O1|Outcome|Boceprevir Peginterferon Ribavirin|12 week Boceprevir peginterferon and ribavirin
115186|NCT01912495|O1|Outcome|Boceprevir, Peginterferon and Ribavirin|12 week Boceprevir, Peginterferon and Ribavirin
115187|NCT01912495|O1|Outcome|Boceprevir, Peginterferon and Ribavirin|12 week boceprevir, peginterferon and ribavirin in intention to treat group
115188|NCT01912495|O1|Outcome|Boceprevir, Peginterferon and Ribavirin|12 week Boceprevir, Peginterferon and Ribavirin
115189|NCT01912495|E1|Reported Event|Boceprevir|12 week Boceprevir, Peginterferon and Ribavirin in RVR4 group
115190|NCT01912404|B3|Baseline|Total|Total of all reporting groups
115191|NCT01912404|B2|Baseline|Placebo|Matching Placebo capsules twice daily for 28 days
115192|NCT01912404|B1|Baseline|IDN-6556|IDN-6556 capsules, 25 mg twice daily for 28 days
115193|NCT01912404|P2|Participant Flow|Placebo|Matching Placebo capsules twice daily for 28 days
115194|NCT01912404|P1|Participant Flow|IDN-6556|IDN-6556 capsules, 25 mg twice daily for 28 days
115195|NCT01912404|O2|Outcome|Placebo|Matching Placebo capsules twice daily for 28 days
115196|NCT01912404|O1|Outcome|IDN-6556|IDN-6556 capsules, 25 mg twice daily for 28 days
115197|NCT01912404|E2|Reported Event|Placebo|Matching Placebo capsules twice daily for 28 days
115198|NCT01912404|E1|Reported Event|IDN-6556|IDN-6556 capsules, 25 mg twice daily for 28 days
115199|NCT01912352|B1|Baseline|Methylphenidate|Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
115200|NCT01912352|P1|Participant Flow|Methylphenidate|Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
115201|NCT01912352|O1|Outcome|Methylphenidate|Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
115202|NCT01912352|O1|Outcome|Methylphenidate|Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
115203|NCT01912352|E1|Reported Event|Methylphenidate|Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
115204|NCT01912339|B3|Baseline|Total|Total of all reporting groups
115205|NCT01912339|B2|Baseline|Control|"Control: Rigid Cystoscopy~Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
115206|NCT01912339|B1|Baseline|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.~Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
115207|NCT01912339|P3|Participant Flow|Crossover of Control Subjects|Subjects randomized to the control group will be offered the option to receive the Rezum treatment after the 3 month follow-up visit evaluations are completed. Subjects must decide to cross over by the end of the 6 month follow-up visit.
115208|NCT01912339|P2|Participant Flow|Control|"Control: Rigid Cystoscopy~Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
115210|NCT01912339|O2|Outcome|Control|"Control: Rigid Cystoscopy~Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
115230|NCT01912222|O2|Outcome|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
119483|NCT01890642|B4|Baseline|Total|Total of all reporting groups
115211|NCT01912339|O1|Outcome|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.~Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
115212|NCT01912339|O2|Outcome|Control|"Control: Rigid Cystoscopy~Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
115213|NCT01912339|O1|Outcome|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.~Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
115214|NCT01912339|O2|Outcome|Control|"Control: Rigid Cystoscopy~Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
115215|NCT01912339|O1|Outcome|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.~Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
115216|NCT01912339|O2|Outcome|Control|"Control: Rigid Cystoscopy~Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
115217|NCT01912339|O1|Outcome|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.~Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
115218|NCT01912339|O2|Outcome|Control|"Control: Rigid Cystoscopy~Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
115219|NCT01912339|O1|Outcome|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.~Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
115220|NCT01912339|E2|Reported Event|Control|"Control: Rigid Cystoscopy~Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
115221|NCT01912339|E1|Reported Event|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.~Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
115222|NCT01912222|B4|Baseline|Total|Total of all reporting groups
115223|NCT01912222|B3|Baseline|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
115224|NCT01912222|B2|Baseline|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
115225|NCT01912222|B1|Baseline|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
115226|NCT01912222|P3|Participant Flow|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
115227|NCT01912222|P2|Participant Flow|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
119630|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
115231|NCT01912222|O1|Outcome|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
115232|NCT01912222|O3|Outcome|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
115233|NCT01912222|O2|Outcome|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
115234|NCT01912222|O1|Outcome|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
115235|NCT01912222|O3|Outcome|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
115236|NCT01912222|O2|Outcome|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
115237|NCT01912222|O1|Outcome|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
115238|NCT01912222|O3|Outcome|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
115239|NCT01912222|O2|Outcome|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
115240|NCT01912222|O1|Outcome|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
115241|NCT01912222|O3|Outcome|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
115242|NCT01912222|O2|Outcome|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
115243|NCT01912222|O1|Outcome|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
115244|NCT01912222|O3|Outcome|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
115245|NCT01912222|O2|Outcome|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
115246|NCT01912222|O1|Outcome|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function..
115247|NCT01912222|E3|Reported Event|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
115248|NCT01912222|E2|Reported Event|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
115249|NCT01912222|E1|Reported Event|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function..
115250|NCT01911845|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
115251|NCT01911845|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
115252|NCT01911845|O2|Outcome|Methadone|Participants were on a stable opioid replacement therapy of methadone during the Treatment Period, and for at least six months prior to screening.
115253|NCT01911845|O1|Outcome|Buprenorphine ± Naloxone|Participants were on a stable opioid replacement therapy of buprenorphine ± naloxone during the Treatment Period, and for at least six months prior to screening.
115254|NCT01911845|O2|Outcome|Methadone|Participants were on a stable opioid replacement therapy of methadone during the Treatment Period, and for at least six months prior to screening.
115255|NCT01911845|O1|Outcome|Buprenorphine ± Naloxone|Participants were on a stable opioid replacement therapy of buprenorphine ± naloxone during the Treatment Period, and for at least six months prior to screening.
115256|NCT01911845|O2|Outcome|Methadone|Participants were on a stable opioid replacement therapy of methadone during the Treatment Period, and for at least six months prior to screening.
115257|NCT01911845|O1|Outcome|Buprenorphine ± Naloxone|Participants were on a stable opioid replacement therapy of buprenorphine ± naloxone during the Treatment Period, and for at least six months prior to screening.
115259|NCT01911845|O1|Outcome|Buprenorphine ± Naloxone|Participants were on a stable opioid replacement therapy of buprenorphine ± naloxone during the Treatment Period, and for at least six months prior to screening.
115260|NCT01911845|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
115261|NCT01911845|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
115262|NCT01911845|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
115263|NCT01911845|E1|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
115264|NCT01911819|B4|Baseline|Total|Total of all reporting groups
115265|NCT01911819|B3|Baseline|Sinus Augmentation Using OSSIF-i Sem|"Sinus augmentation using OSSIF-i sem~Sinus augmentation~OSSIF-i sem: OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 5cc"
115266|NCT01911819|B2|Baseline|Sinus Augmentation Using Equimatrix|"Sinus augmentation using Equimatrix~Sinus augmentation~Equimatrix: Equimatrix cancellous particle size 0.2-1mm approximately 2.5g (5cc)"
115267|NCT01911819|B1|Baseline|Sinus Augmentation Using Bio-oss|"Sinus augmentation using Bio-oss~Sinus augmentation~Bio-oss: Bio-oss small granules cancellous 0.25-1mm, approximately 2.5g (5cc)"
115268|NCT01911819|P3|Participant Flow|Sinus Augmentation Using OSSIF-i Sem|"Sinus augmentation using OSSIF-i sem~Sinus augmentation~OSSIF-i sem: OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 5cc"
115269|NCT01911819|P2|Participant Flow|Sinus Augmentation Using Bio-oss|"Sinus augmentation using Bio-oss~Sinus augmentation~Bio-oss: Bio-oss small granules cancellous 0.25-1mm, approximately 2.5g (5cc)"
115270|NCT01911819|P1|Participant Flow|Sinus Augmentation Using Equimatrix|"Sinus augmentation using Equimatrix~Sinus augmentation~Equimatrix: Equimatrix cancellous particle size 0.2-1mm approximately 2.5g (5cc)"
115271|NCT01911819|O3|Outcome|Sinus Augmentation Using OSSIF-i Sem|"Sinus augmentation using OSSIF-i sem~Sinus augmentation~OSSIF-i sem: OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 5cc"
115272|NCT01911819|O2|Outcome|Sinus Augmentation Using Equimatrix|"Sinus augmentation using Equimatrix~Sinus augmentation~Equimatrix: Equimatrix cancellous particle size 0.2-1mm approximately 2.5g (5cc)"
115273|NCT01911819|O1|Outcome|Sinus Augmentation Using Bio-oss|"Sinus augmentation using Bio-oss~Sinus augmentation~Bio-oss: Bio-oss small granules cancellous 0.25-1mm, approximately 2.5g (5cc)"
115274|NCT01911819|O3|Outcome|Sinus Augmentation Using OSSIF-i Sem|"Sinus augmentation using OSSIF-i sem~Sinus augmentation~OSSIF-i sem: OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 5cc"
115275|NCT01911819|O2|Outcome|Sinus Augmentation Using Equimatrix|"Sinus augmentation using Equimatrix~Sinus augmentation~Equimatrix: Equimatrix cancellous particle size 0.2-1mm approximately 2.5g (5cc)"
115276|NCT01911819|O1|Outcome|Sinus Augmentation Using Bio-oss|"Sinus augmentation using Bio-oss~Sinus augmentation~Bio-oss: Bio-oss small granules cancellous 0.25-1mm, approximately 2.5g (5cc)"
115277|NCT01911819|E3|Reported Event|Sinus Augmentation Using OSSIF-i Sem|"Sinus augmentation using OSSIF-i sem~Sinus augmentation~OSSIF-i sem: OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 5cc"
115278|NCT01911819|E2|Reported Event|Sinus Augmentation Using Equimatrix|"Sinus augmentation using Equimatrix~Sinus augmentation~Equimatrix: Equimatrix cancellous particle size 0.2-1mm approximately 2.5g (5cc)"
115279|NCT01911819|E1|Reported Event|Sinus Augmentation Using Bio-oss|"Sinus augmentation using Bio-oss~Sinus augmentation~Bio-oss: Bio-oss small granules cancellous 0.25-1mm, approximately 2.5g (5cc)"
115280|NCT01911793|B3|Baseline|Total|Total of all reporting groups
115281|NCT01911793|B2|Baseline|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
115282|NCT01911793|B1|Baseline|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery~Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
115283|NCT01911793|P2|Participant Flow|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
115284|NCT01911793|P1|Participant Flow|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery~Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
115285|NCT01911793|O2|Outcome|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
115286|NCT01911793|O1|Outcome|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery~Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
115287|NCT01911793|O2|Outcome|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
115288|NCT01911793|O1|Outcome|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery~Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
115289|NCT01911793|O2|Outcome|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
119631|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
115290|NCT01911793|O1|Outcome|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery~Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
115291|NCT01911793|O2|Outcome|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
115292|NCT01911793|O1|Outcome|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery~Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
115293|NCT01911793|O2|Outcome|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
115294|NCT01911793|O1|Outcome|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery~Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
115295|NCT01911793|O2|Outcome|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
115296|NCT01911793|O1|Outcome|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery~Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
115297|NCT01911793|O2|Outcome|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
115298|NCT01911793|O1|Outcome|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery~Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
115299|NCT01911793|O2|Outcome|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
115300|NCT01911793|O1|Outcome|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery~Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
115301|NCT01911793|O2|Outcome|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
115302|NCT01911793|O1|Outcome|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery~Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
115303|NCT01911793|E2|Reported Event|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
115304|NCT01911793|E1|Reported Event|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery~Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
115305|NCT01911780|B3|Baseline|Total|Total of all reporting groups
115306|NCT01911780|B2|Baseline|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
115307|NCT01911780|B1|Baseline|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
115308|NCT01911780|P2|Participant Flow|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
115309|NCT01911780|P1|Participant Flow|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
115310|NCT01911780|O2|Outcome|Telmisartan + HCTZ + Placebo + Ext|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
115311|NCT01911780|O1|Outcome|Telmisartan + HCTZ + Amlodipine + Ext|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
115312|NCT01911780|O2|Outcome|Telmisartan + HCTZ + Placebo + Ext|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
115313|NCT01911780|O1|Outcome|Telmisartan + HCTZ + Amlodipine + Ext|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
115384|NCT01911429|P3|Participant Flow|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
119632|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
115314|NCT01911780|O2|Outcome|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
115315|NCT01911780|O1|Outcome|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
115316|NCT01911780|O2|Outcome|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
115317|NCT01911780|O1|Outcome|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
115318|NCT01911780|O2|Outcome|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
115319|NCT01911780|O1|Outcome|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
115320|NCT01911780|O2|Outcome|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
115321|NCT01911780|O1|Outcome|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
115322|NCT01911780|E4|Reported Event|Telmisartan + HCTZ + Placebo - Extension Period|Patients in the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet who previously received telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily for 8 weeks in the double-blind period. Adverse events which occurred in extension period were collected.
115323|NCT01911780|E3|Reported Event|Telmisartan + HCTZ + Amlodipine - Extension Period|Patients in the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet who previously received telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily for 8 weeks in the double blind period. Adverse events which occurred in extension period were collected.
115324|NCT01911780|E2|Reported Event|Telmisartan + HCTZ + Placebo - Double Blind Period|Telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily for 8 weeks (double-blind period)
115325|NCT01911780|E1|Reported Event|Telmisartan + HCTZ + Amlodipine - Double Blind Period|Telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily for 8 weeks (double blind period)
115326|NCT01911689|B3|Baseline|Total|Total of all reporting groups
115327|NCT01911689|B2|Baseline|Controlgroup|All MRI examinations were performed with a 3.0T scanner (Discovery MR 750; GE Medical Systems, Milwaukee, Wis) in the supine position.
115328|NCT01911689|B1|Baseline|Acute Pancreatitis|All AP patients underwent the MRI scan within three days after admission. All MRI examinations were performed with a 3.0T scanner (Discovery MR 750; GE Medical Systems, Milwaukee, Wis) in the supine position.
115329|NCT01911689|P2|Participant Flow|Controlgroup|normal control group：without pancreatic disorders.The exclusion criteria in this study were as follows: (a) inability to cooperate when MR imaging was performed; (b) a history of chronic pancreatitis; (c) AP due to pancreatic carcinoma; (d) hypoproteinemia; and (e) with hypoproteinemia and other peritoneal/ retroperitoneal infection diseases ;(f) with iron deposition disorder (e.g. diabetes or blood system diseases).
115330|NCT01911689|P1|Participant Flow|Acute Pancreatitis|acute pancreatitis group：(a) acute onset of abdominal pain; (b) pancreatitis at first onset; (c) three-fold elevated amylase or lipase, excluding other causes of elevated enzymes; and (5) abdominal MR examination.
115331|NCT01911689|O2|Outcome|Severe AP|Severe AP was graded as the Apache II score ≥8 points.
115332|NCT01911689|O1|Outcome|Mild AP|Mild AP was graded as the Apache II score ＜ 7 points.
115333|NCT01911689|O3|Outcome|Severe AP|Severe AP was defined as 7-10 points according to MRSI.
115334|NCT01911689|O2|Outcome|Moderate AP|Moderate AP was defined as 4-6 points according to MRSI.
115335|NCT01911689|O1|Outcome|Mild AP|Mild AP was defined as 0-3 points according to MRSI.
115336|NCT01911689|O2|Outcome|Necrotizing AP|T2* value of necrotizing AP
115337|NCT01911689|O1|Outcome|Edematous AP|T2* value of edematous AP
115338|NCT01911689|O2|Outcome|Control Group|T2* value of control group is mean T2* values of the head, body and tail of pancreas respectively.The control group:without pancreatic disorders
115339|NCT01911689|O1|Outcome|Acute Pancreatitis|T2* value of AP group is mean T2* values of the head, body and tail of pancreas respectively (If AP with necrosis, measureing the corresponding to the area with no necrosis).The AP group:(a) acute onset of abdominal pain; (b) pancreatitis at first onset; (c) three-fold elevated amylase or lipase, excluding other causes of elevated enzymes; and (5) abdominal MR examination
115340|NCT01911689|E2|Reported Event|Controlgroup|Not Including Serious
115341|NCT01911689|E1|Reported Event|Acute Pancreatitis|Not Including Serious
115437|NCT01911390|B5|Baseline|Total|Total of all reporting groups
119633|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
115342|NCT01911546|B1|Baseline|Everolimus + Low-dose Tacrolimus|"Patients receiving everolimus will be on low dose tacrolimus.~everolimus + low-dose tacrolimus: Patients are supplied everolimus (Zortress) + prograf"
115343|NCT01911546|P1|Participant Flow|Everolimus + Low-dose Tacrolimus|"20 patients received everolimus with low dose tacrolimus.~Everolimus + low-dose tacrolimus: Patients are supplied everolimus (Zortress) + prograf"
115344|NCT01911546|O1|Outcome|Everolimus + Low-dose Tacrolimus|"20 patients received everolimus with low dose tacrolimus.~Everolimus + low-dose tacrolimus: Patients are supplied everolimus (Zortress) + prograf"
115345|NCT01911546|O1|Outcome|Everolimus + Low-dose Tacrolimus|"20 patients received everolimus with low dose tacrolimus.~Everolimus + low-dose tacrolimus: Patients are supplied everolimus (Zortress) + prograf"
115346|NCT01911546|O1|Outcome|Everolimus + Low-dose Tacrolimus|"20 patients received everolimus with low dose tacrolimus.~Everolimus + low-dose tacrolimus: Patients are supplied everolimus (Zortress) + prograf"
115347|NCT01911546|O1|Outcome|Everolimus + Low-dose Tacrolimus|"20 patients received everolimus with low dose tacrolimus.~Everolimus + low-dose tacrolimus: Patients are supplied everolimus (Zortress) + prograf"
115348|NCT01911546|E1|Reported Event|Everolimus + Low-dose Tacrolimus|"20 patients received everolimus with low dose tacrolimus.~Everolimus + low-dose tacrolimus: Patients are supplied everolimus (Zortress) + prograf"
115349|NCT01911442|B4|Baseline|Total|Total of all reporting groups
115350|NCT01911442|B3|Baseline|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
115351|NCT01911442|B2|Baseline|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
115352|NCT01911442|B1|Baseline|Lurasidone 20 mg Once Daily|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
115353|NCT01911442|P3|Participant Flow|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
115354|NCT01911442|P2|Participant Flow|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
115355|NCT01911442|P1|Participant Flow|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
115356|NCT01911442|O3|Outcome|Placebo|"Placebo once daily~Placebo: Placebo"
115357|NCT01911442|O2|Outcome|Lurasidone 60 mg|"Lurasidone 60 mg once daily~Lurasidone: Lurasidone 60 mg once daily"
115358|NCT01911442|O1|Outcome|Lurasidone 20 mg|"Lurasidone 20 mg once daily~Lurasidone 20 mg daily: Lurasidone 20 mg once daily"
115359|NCT01911442|O3|Outcome|Placebo|"Placebo once daily~Placebo: Placebo"
115360|NCT01911442|O2|Outcome|Lurasidone 60 mg|"Lurasidone 60 mg once daily~Lurasidone: Lurasidone 60 mg once daily"
115361|NCT01911442|O1|Outcome|Lurasidone 20 mg|"Lurasidone 20 mg once daily~Lurasidone 20 mg daily: Lurasidone 20 mg once daily"
115362|NCT01911442|O3|Outcome|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
115363|NCT01911442|O2|Outcome|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
115364|NCT01911442|O1|Outcome|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
115365|NCT01911442|O3|Outcome|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
115366|NCT01911442|O2|Outcome|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
115367|NCT01911442|O1|Outcome|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
115368|NCT01911442|O3|Outcome|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
115369|NCT01911442|O2|Outcome|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
115370|NCT01911442|O1|Outcome|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
115371|NCT01911442|O3|Outcome|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
115372|NCT01911442|O2|Outcome|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
115373|NCT01911442|O1|Outcome|Lurasidone 20 mg Once Daily|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
115374|NCT01911442|O3|Outcome|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
115375|NCT01911442|O2|Outcome|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
115376|NCT01911442|O1|Outcome|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
115377|NCT01911442|E3|Reported Event|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
115378|NCT01911442|E2|Reported Event|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
115379|NCT01911442|E1|Reported Event|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
115380|NCT01911429|B4|Baseline|Total|Total of all reporting groups
115381|NCT01911429|B3|Baseline|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
115382|NCT01911429|B2|Baseline|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily"
115383|NCT01911429|B1|Baseline|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
115385|NCT01911429|P2|Participant Flow|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily Subjects received lurasidone 40/mg day from Days 1-3, and 80mg/day from days 4 to Week 6 visit"
115386|NCT01911429|P1|Participant Flow|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
115387|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
115388|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily"
115389|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
115390|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
115391|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily"
115392|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
115393|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
115394|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily"
115395|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
115396|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
115397|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily"
115398|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
115399|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
115400|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily"
115401|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
115402|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
115403|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily"
115404|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
115405|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
115406|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily"
115407|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
115408|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
115409|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily"
115410|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
115411|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
115412|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily"
115413|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
115414|NCT01911429|E3|Reported Event|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
115415|NCT01911429|E2|Reported Event|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily"
115416|NCT01911429|E1|Reported Event|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
115417|NCT01911403|B3|Baseline|Total|Total of all reporting groups
115418|NCT01911403|B2|Baseline|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
115419|NCT01911403|B1|Baseline|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
115420|NCT01911403|P2|Participant Flow|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
115421|NCT01911403|P1|Participant Flow|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
115422|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
115423|NCT01911403|O2|Outcome|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
115424|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
115425|NCT01911403|O2|Outcome|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
115426|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
115427|NCT01911403|O2|Outcome|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
115428|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
115429|NCT01911403|O2|Outcome|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
115430|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
115431|NCT01911403|O2|Outcome|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
115432|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
115433|NCT01911403|O2|Outcome|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
115434|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
115435|NCT01911403|E2|Reported Event|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
115436|NCT01911403|E1|Reported Event|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
115438|NCT01911390|B4|Baseline|Bean Powder and Rice Bran|"9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin.~Bean powder and rice bran: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders. USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
115439|NCT01911390|B3|Baseline|Rice Bran|"15 grams rice bran/day in smoothie or muffin.~Rice bran: USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
115440|NCT01911390|B2|Baseline|Bean Powder|"1/4 cup beans (17.5 grams powder)/day in smoothie or muffin.~Bean powder: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders."
115441|NCT01911390|B1|Baseline|Control Arm|"No bean or rice bran additive in smoothie or muffin.~Control arm: No bean or rice bran additive in smoothie or muffin."
115442|NCT01911390|P4|Participant Flow|Bean Powder and Rice Bran|"9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin.~Bean powder and rice bran: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders. USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
115443|NCT01911390|P3|Participant Flow|Rice Bran|"15 grams rice bran/day in smoothie or muffin.~Rice bran: USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
115444|NCT01911390|P2|Participant Flow|Bean Powder|"1/4 cup beans (17.5 grams powder)/day in smoothie or muffin.~Bean powder: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders."
115445|NCT01911390|P1|Participant Flow|Control Arm|"No bean or rice bran additive in smoothie or muffin.~Control arm: No bean or rice bran additive in smoothie or muffin."
115446|NCT01911390|O4|Outcome|Bean Powder and Rice Bran|"9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin.~Bean powder and rice bran: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders. USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
115447|NCT01911390|O3|Outcome|Rice Bran|"15 grams rice bran/day in smoothie or muffin.~Rice bran: USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
115448|NCT01911390|O2|Outcome|Bean Powder|"1/4 cup beans (17.5 grams powder)/day in smoothie or muffin.~Bean powder: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders."
115449|NCT01911390|O1|Outcome|Control Arm|"No bean or rice bran additive in smoothie or muffin.~Control arm: No bean or rice bran additive in smoothie or muffin."
115450|NCT01911390|O4|Outcome|Bean Powder and Rice Bran|"9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin.~Bean powder and rice bran: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders. USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
115451|NCT01911390|O3|Outcome|Rice Bran|"15 grams rice bran/day in smoothie or muffin.~Rice bran: USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
115452|NCT01911390|O2|Outcome|Bean Powder|"1/4 cup beans (17.5 grams powder)/day in smoothie or muffin.~Bean powder: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders."
115453|NCT01911390|O1|Outcome|Control Arm|"No bean or rice bran additive in smoothie or muffin.~Control arm: No bean or rice bran additive in smoothie or muffin."
115454|NCT01911390|E4|Reported Event|Bean Powder and Rice Bran|"9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin.~Bean powder and rice bran: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders. USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
115455|NCT01911390|E3|Reported Event|Rice Bran|"15 grams rice bran/day in smoothie or muffin.~Rice bran: USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
115456|NCT01911390|E2|Reported Event|Bean Powder|"1/4 cup beans (17.5 grams powder)/day in smoothie or muffin.~Bean powder: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders."
115457|NCT01911390|E1|Reported Event|Control Arm|"No bean or rice bran additive in smoothie or muffin.~Control arm: No bean or rice bran additive in smoothie or muffin."
115458|NCT01911351|B3|Baseline|Total|Total of all reporting groups
115459|NCT01911351|B2|Baseline|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
115460|NCT01911351|B1|Baseline|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
115461|NCT01911351|P2|Participant Flow|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
115462|NCT01911351|P1|Participant Flow|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
115463|NCT01911351|O2|Outcome|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
115464|NCT01911351|O1|Outcome|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
115465|NCT01911351|O2|Outcome|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
115466|NCT01911351|O1|Outcome|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
115467|NCT01911351|O2|Outcome|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
115468|NCT01911351|O1|Outcome|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
115469|NCT01911351|O2|Outcome|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
115470|NCT01911351|O1|Outcome|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
115471|NCT01911351|O2|Outcome|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
115472|NCT01911351|O1|Outcome|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
115473|NCT01911351|E2|Reported Event|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
115474|NCT01911351|E1|Reported Event|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
115475|NCT01911273|B3|Baseline|Total|Total of all reporting groups
115476|NCT01911273|B2|Baseline|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
115477|NCT01911273|B1|Baseline|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
115478|NCT01911273|P2|Participant Flow|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
115479|NCT01911273|P1|Participant Flow|PF-03446962 Plus BSC|PF-03446962 7 milligram per kilogram (mg/kg) was administered intravenously (IV) as 1-hour infusion every two weeks (q2w) plus BSC
115480|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
115481|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
115482|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
115483|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
115484|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
115485|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
115486|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
115487|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
115488|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
115489|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
115490|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
115491|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
115492|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
115493|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
115494|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
115495|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
115496|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
115497|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
115498|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
115499|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
115500|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
115501|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
115502|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
115503|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
115504|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
115505|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
115506|NCT01911273|E2|Reported Event|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
115507|NCT01911273|E1|Reported Event|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
115508|NCT01911260|B5|Baseline|Total|Total of all reporting groups
115509|NCT01911260|B4|Baseline|Normal Height + Placebo|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
115510|NCT01911260|B3|Baseline|Normal Height+Zinc Amino Acid Chelate|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
115511|NCT01911260|B2|Baseline|Growth Deficit + Placebo|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
115512|NCT01911260|B1|Baseline|Growth Deficit+Zinc Amino Acid Chelate|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
115513|NCT01911260|P4|Participant Flow|Normal Height + Placebo|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
115514|NCT01911260|P3|Participant Flow|Normal Height+Zinc Amino Acid Chelate|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
115515|NCT01911260|P2|Participant Flow|Growth Deficit + Placebo|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
115516|NCT01911260|P1|Participant Flow|Growth Deficit+Zinc Amino Acid Chelate|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
115517|NCT01911260|O4|Outcome|Normal Height + Placebo|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
115542|NCT01911169|P2|Participant Flow|Vitamin D 400|"cholecalciferol 400 IU daily by mouth~Cholecalciferol: 5,000 International units versus 400 international units as an active comparator"
119634|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
115518|NCT01911260|O3|Outcome|Normal Height+Zinc Amino Acid Chelate|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
115519|NCT01911260|O2|Outcome|Growth Deficit + Placebo|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
115520|NCT01911260|O1|Outcome|Growth Deficit+Zinc Amino Acid Chelate|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
115521|NCT01911260|E4|Reported Event|Normal Height Receiving Placebo|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
115522|NCT01911260|E3|Reported Event|Normal Height+Zinc Amino Acid Chelate|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
115523|NCT01911260|E2|Reported Event|Growth Deficit Receiving Placebo|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
115524|NCT01911260|E1|Reported Event|Growth Deficit+Zinc Amino Acid Chelate|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
115525|NCT01911221|B1|Baseline|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ at 0 month and 2 month schedule.
115526|NCT01911221|P1|Participant Flow|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ at 0 month and 2 month schedule.
115527|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
115528|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
115529|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
115530|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
115531|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
115532|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
115533|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
115534|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
115535|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
115536|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
115537|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
115538|NCT01911221|E1|Reported Event|rMenB+OMVNZ|Subjects received two doses of rMenB +OMV NZ at 0 month and 2 month schedule.
115539|NCT01911169|B3|Baseline|Total|Total of all reporting groups
115540|NCT01911169|B2|Baseline|Vitamin D 400|"cholecalciferol 400 IU daily by mouth~Cholecalciferol: 5,000 International units versus 400 international units as an active comparator"
115541|NCT01911169|B1|Baseline|Vitamin D 5000|"5,000 IU vitamin D (cholecalciferol) given orally daily~Cholecalciferol: 5,000 International units versus 400 international units as an active comparator"
115780|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115543|NCT01911169|P1|Participant Flow|Vitamin D 5000|"5,000 IU vitamin D (cholecalciferol) given orally daily~Cholecalciferol: 5,000 International units versus 400 international units as an active comparator"
115544|NCT01911169|O2|Outcome|Not Repleted Vitamin D|Participants whose vitamin D therapy failed to replete final serum levels to > 32 ng/ml after 16 weeks of treatment
115545|NCT01911169|O1|Outcome|Repleted Vitamin D|Participants whose final serum 25(OH) vitamin D was > 32 ng/ml after 16 weeks of oral vitamin D
115546|NCT01911169|O2|Outcome|Not Repleted Vitamin D|Participants whose vitamin D therapy failed to replete final serum levels to > 32 ng/ml after 16 weeks of treatment
115547|NCT01911169|O1|Outcome|Repleted Vitamin D|Participants whose final serum 25(OH) vitamin D was > 32 ng/ml after 16 weeks of oral vitamin D
115548|NCT01911169|E2|Reported Event|Vitamin D 400|"cholecalciferol 400 IU daily by mouth~Cholecalciferol: 5,000 International units versus 400 international units as an active comparator"
115549|NCT01911169|E1|Reported Event|Vitamin D 5000|"5,000 IU vitamin D (cholecalciferol) given orally daily~Cholecalciferol: 5,000 International units versus 400 international units as an active comparator"
115550|NCT01911065|B3|Baseline|Total|Total of all reporting groups
115551|NCT01911065|B2|Baseline|Naturally-acquired VZV Immunity|Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).
115552|NCT01911065|B1|Baseline|Zostavax™ Vaccine Group|Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
115553|NCT01911065|P2|Participant Flow|Naturally-acquired VZV Immunity|Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).
115554|NCT01911065|P1|Participant Flow|Zostavax™ Vaccine Group|Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
115555|NCT01911065|O2|Outcome|Naturally-acquired VZV Immunity|Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).
115556|NCT01911065|O1|Outcome|Zostavax™ Vaccine Group|Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
115557|NCT01911065|O2|Outcome|Naturally-acquired VZV Immunity|Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).
115558|NCT01911065|O1|Outcome|Zostavax™ Vaccine Group|Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
115559|NCT01911065|E2|Reported Event|Naturally-acquired VZV Immunity|Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).
115560|NCT01911065|E1|Reported Event|Zostavax™ Vaccine Group|Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
115561|NCT01910831|B1|Baseline|All Participants|Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Applied twice daily for 12 weeks. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.
115562|NCT01910831|P1|Participant Flow|DerMend Moisturizing Bruise Formula vs. Vehicle Control|"Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.~DerMend Moisturizing Bruise Formula vs. Vehicle control."
115563|NCT01910831|O2|Outcome|LEFT Arm Randomized to Non-active Placebo Control|Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.
115564|NCT01910831|O1|Outcome|LEFT Arm Randomized to DerMend Moisturizing Bruise Formula|"Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Applied twice daily for 12 weeks. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.~DerMend Moisturizing Bruise Formula"
115565|NCT01910831|O2|Outcome|LEFT Arm Randomized to Non-active Placebo Control|Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.
115566|NCT01910831|O1|Outcome|LEFT Arm Randomized to DerMend Moisturizing Bruise Formula|"Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Applied twice daily for 12 weeks. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.~DerMend Moisturizing Bruise Formula"
115567|NCT01910831|E1|Reported Event|All Participants|Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Applied twice daily for 12 weeks. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.
115568|NCT01910792|B3|Baseline|Total|Total of all reporting groups
115569|NCT01910792|B2|Baseline|Group 1|"Patients with fat malabsorption syndromes will be exposed to a Sperti Lamp 3x/week~Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
115781|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115570|NCT01910792|B1|Baseline|Group 2|"Patients who have had gastric bypass surgery will be exposed to a Sperti Lamp 3x/week~Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
115571|NCT01910792|P2|Participant Flow|Pts w/ Fat Malabsorption|"Patients with fat malabsorption syndromes will be exposed to a Sperti Lamp 3x/week~Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
115572|NCT01910792|P1|Participant Flow|Pts w/ Gastric Bypass|"Patients who have had gastric bypass surgery will be exposed to a Sperti Lamp 3x/week~Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
115573|NCT01910792|O2|Outcome|Pts w/ Fat Malabsorption|"Patients with fat malabsorption syndromes will be exposed to a Sperti Lamp 3x/week~Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
115574|NCT01910792|O1|Outcome|Pts w/ Gastric Bypass|"Patients who have had gastric bypass surgery will be exposed to a Sperti Lamp 3x/week~Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
115575|NCT01910792|E2|Reported Event|Pts w/ Fat Malabsorption|"Patients with fat malabsorption syndromes will be exposed to a Sperti Lamp 3x/week~Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
115576|NCT01910792|E1|Reported Event|Pts w/ Gastric Bypass|"Patients who have had gastric bypass surgery will be exposed to a Sperti Lamp 3x/week~Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
115577|NCT01910688|B1|Baseline|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.~RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
115578|NCT01910688|P1|Participant Flow|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.~RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
115579|NCT01910688|O1|Outcome|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.~RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
115580|NCT01910688|O1|Outcome|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.~RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
115581|NCT01910688|O1|Outcome|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.~RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
115582|NCT01910688|O1|Outcome|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.~RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
115614|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115583|NCT01910688|E1|Reported Event|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.~RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
115584|NCT01910636|B3|Baseline|Total|Total of all reporting groups
115585|NCT01910636|B2|Baseline|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
115586|NCT01910636|B1|Baseline|SOF+RBV Treatment Naive|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
115587|NCT01910636|P2|Participant Flow|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
115588|NCT01910636|P1|Participant Flow|SOF+RBV Treatment Naive|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
115589|NCT01910636|O2|Outcome|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
115590|NCT01910636|O1|Outcome|SOF+RBV Treatment Naive|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
115591|NCT01910636|O2|Outcome|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
115592|NCT01910636|O1|Outcome|SOF+RBV Treatment Naive|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
115593|NCT01910636|O2|Outcome|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
115594|NCT01910636|O1|Outcome|SOF+RBV Treatment Naive|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
115595|NCT01910636|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks
115596|NCT01910636|O2|Outcome|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
115597|NCT01910636|O1|Outcome|SOF+RBV Treatment Naive|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
115598|NCT01910636|E1|Reported Event|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks
115599|NCT01910441|B3|Baseline|Total|Total of all reporting groups
115600|NCT01910441|B2|Baseline|Group B: Glimepiride Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
115601|NCT01910441|B1|Baseline|Group A: Vildagliptin Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
115602|NCT01910441|P2|Participant Flow|Group B: Glimepiride Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
115603|NCT01910441|P1|Participant Flow|Group A: Vildagliptin Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
115604|NCT01910441|O2|Outcome|Group B: Glimepiride Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
115605|NCT01910441|O1|Outcome|Group A: Vildagliptin Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
115606|NCT01910441|E2|Reported Event|Group B: Glimepiride Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
115607|NCT01910441|E1|Reported Event|Group A: Vildagliptin Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
115608|NCT01910402|B3|Baseline|Total|Total of all reporting groups
115609|NCT01910402|B2|Baseline|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115610|NCT01910402|B1|Baseline|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115611|NCT01910402|P2|Participant Flow|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115612|NCT01910402|P1|Participant Flow|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115613|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115615|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115722|NCT01910311|E1|Reported Event|Baricitinib|"A 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.~Adverse events (AEs) are reported from baseline through predose on Day 3."
115616|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115617|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115618|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115619|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115620|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115621|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115622|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115623|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115624|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated..
115625|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115626|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115627|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115628|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115629|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115630|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115631|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115632|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115633|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115774|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115634|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115635|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115636|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated..
115637|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115638|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115639|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115640|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115641|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115642|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115643|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115644|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115645|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115646|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115647|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115648|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115649|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115650|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115651|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115775|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115652|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115653|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115654|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115655|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115656|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115657|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115658|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115659|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115660|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115661|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115662|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115663|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115664|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115665|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115666|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115667|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115668|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115669|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115776|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115670|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115671|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115672|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115673|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115674|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it wasi) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115675|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115676|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
115677|NCT01910402|E2|Reported Event|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
115678|NCT01910402|E1|Reported Event|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TD FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TD FDC was discontinued/terminated.
115679|NCT01910389|B3|Baseline|Total|Total of all reporting groups
115680|NCT01910389|B2|Baseline|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
115681|NCT01910389|B1|Baseline|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
115682|NCT01910389|P2|Participant Flow|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
115683|NCT01910389|P1|Participant Flow|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
115684|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
115685|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
115686|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
115687|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
115688|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
115689|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
115690|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
115691|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
115692|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
115777|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115693|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
115694|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
115695|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
115696|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
115697|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
115698|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
115699|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
115700|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
115701|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
115702|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
115703|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
115704|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
115705|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
115706|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
115707|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
115708|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
115709|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
115710|NCT01910389|E2|Reported Event|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
115711|NCT01910389|E1|Reported Event|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
115712|NCT01910311|B1|Baseline|Baricitinib Then Baricitinib and Rifampicin|"Period 1: 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.~Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 11, with coadministration of a 10-mg dose of baricitinib on Day 10."
115713|NCT01910311|P1|Participant Flow|Baricitinib Then Baricitinib and Rifampicin|"Period 1: 10-milligram (mg) dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.~Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally once daily (QD) on Days 3 through 11, with coadministration of a 10-mg dose of baricitinib on Day 10."
115714|NCT01910311|O2|Outcome|Baricitinib and Rifampicin|Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 11, with coadministration of a 10-mg dose of baricitinib on Day 10.
115715|NCT01910311|O1|Outcome|Baricitinib|Period 1: 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.
115716|NCT01910311|O2|Outcome|Baricitinib and Rifampicin|Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 11, with a coadministration of 10-mg dose of baricitinib on Day 10.
115717|NCT01910311|O1|Outcome|Baricitinib|Period 1: 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.
115718|NCT01910311|O2|Outcome|Baricitinib and Rifampicin|Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 11, with coadministration of a 10-mg dose of baricitinib on Day 10.
115719|NCT01910311|O1|Outcome|Baricitinib|Period 1: 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.
115720|NCT01910311|E3|Reported Event|Baricitinib and Rifampicin|"A 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 10 and 11, with coadministration of a 10-mg dose of baricitinib on Day 10.~AEs are reported postdose on Day 10 up to Day 32."
115721|NCT01910311|E2|Reported Event|Rifampicin|"A 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 9.~AEs are reported postdose on Day 3 through predose on Day 10."
115778|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115723|NCT01910181|B1|Baseline|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
115724|NCT01910181|P1|Participant Flow|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 milligrams (mg) twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The Pharmacokinetic (PK) Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
115725|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
115726|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
115727|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
115728|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
115729|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
115730|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
115731|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
115732|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
115733|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
115734|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
115735|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
115736|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
115737|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
115779|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
119635|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
115738|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
115739|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
115740|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
115741|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
115742|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
115743|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
115744|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
115745|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
115746|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
115747|NCT01910181|E1|Reported Event|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
115748|NCT01910116|B3|Baseline|Total|Total of all reporting groups
115749|NCT01910116|B2|Baseline|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115750|NCT01910116|B1|Baseline|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115751|NCT01910116|P2|Participant Flow|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~Placebo"
115752|NCT01910116|P1|Participant Flow|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~Shinbaro"
115753|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115754|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115755|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115756|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115757|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115758|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115759|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115760|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115761|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115762|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115763|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115764|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115765|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115766|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115767|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115768|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115769|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115770|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115771|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115772|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115773|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
119636|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
115782|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115783|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115784|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115785|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115786|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115787|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115788|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115789|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115790|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115791|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115792|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115793|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115794|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115795|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115796|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115797|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115798|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115799|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115800|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115801|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115802|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115803|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115804|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115805|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115806|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115807|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115808|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115809|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115810|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115811|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115812|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115813|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115814|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115815|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115816|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115817|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115818|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115819|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115820|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115821|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115822|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115823|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115824|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115825|NCT01910116|E2|Reported Event|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
115826|NCT01910116|E1|Reported Event|Shinbaro|"GCSB-5 (Shinbaro), 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
115827|NCT01910064|B1|Baseline|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
115828|NCT01910064|P1|Participant Flow|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
115829|NCT01910064|O1|Outcome|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
115830|NCT01910064|O1|Outcome|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
115831|NCT01910064|O1|Outcome|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
115832|NCT01910064|O1|Outcome|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
115833|NCT01910064|O1|Outcome|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
115834|NCT01910064|O1|Outcome|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
115835|NCT01910064|E1|Reported Event|GK530G|GK530G is the fixed-dose combination gel of Adapalene and Benzoyl Peroxide, BPO
115836|NCT01909804|B13|Baseline|Total|Total of all reporting groups
115837|NCT01909804|B12|Baseline|SOF+VEL 100 mg + RBV (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
119637|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
115838|NCT01909804|B11|Baseline|SOF+VEL 100 mg (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
115839|NCT01909804|B10|Baseline|SOF+VEL 25 mg + RBV (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
115840|NCT01909804|B9|Baseline|SOF+VEL 25 mg (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
115841|NCT01909804|B8|Baseline|SOF+VEL 100 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
115842|NCT01909804|B7|Baseline|SOF+VEL 100 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
115843|NCT01909804|B6|Baseline|SOF+VEL 25 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
115844|NCT01909804|B5|Baseline|SOF+VEL 25 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
115845|NCT01909804|B4|Baseline|SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
115846|NCT01909804|B3|Baseline|SOF+VEL 100 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
115847|NCT01909804|B2|Baseline|SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
115848|NCT01909804|B1|Baseline|SOF+VEL 25 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
115849|NCT01909804|P12|Participant Flow|SOF+VEL 100 mg + RBV (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
115850|NCT01909804|P11|Participant Flow|SOF+VEL 100 mg (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
115851|NCT01909804|P10|Participant Flow|SOF+VEL 25 mg + RBV (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
115852|NCT01909804|P9|Participant Flow|SOF+VEL 25 mg (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
115853|NCT01909804|P8|Participant Flow|SOF+VEL 100 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
115854|NCT01909804|P7|Participant Flow|SOF+VEL 100 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
115855|NCT01909804|P6|Participant Flow|SOF+VEL 25 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
115856|NCT01909804|P5|Participant Flow|SOF+VEL 25 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
115857|NCT01909804|P4|Participant Flow|SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
115858|NCT01909804|P3|Participant Flow|SOF+VEL 100 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
115859|NCT01909804|P2|Participant Flow|SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + velpatasvir (VEL) 25 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
115860|NCT01909804|P1|Participant Flow|SOF+VEL 25 mg (GT3 Non-Cirrhotic)|Sofosbuvir (SOF) 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
115861|NCT01909804|O12|Outcome|SOF+VEL 100 mg + RBV (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
115862|NCT01909804|O11|Outcome|SOF+VEL 100 mg (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
115863|NCT01909804|O10|Outcome|SOF+VEL 25 mg + RBV (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
115864|NCT01909804|O9|Outcome|SOF+VEL 25 mg (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
115865|NCT01909804|O8|Outcome|SOF+VEL 100 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
115866|NCT01909804|O7|Outcome|SOF+VEL 100 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
115867|NCT01909804|O6|Outcome|SOF+VEL 25 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
115868|NCT01909804|O5|Outcome|SOF+VEL 25 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
115869|NCT01909804|O4|Outcome|SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
115870|NCT01909804|O3|Outcome|SOF+VEL 100 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
115871|NCT01909804|O2|Outcome|SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
115872|NCT01909804|O1|Outcome|SOF+VEL 25 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
115873|NCT01909804|O12|Outcome|SOF+VEL 100 mg + RBV (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
115874|NCT01909804|O11|Outcome|SOF+VEL 100 mg (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
115875|NCT01909804|O10|Outcome|SOF+VEL 25 mg + RBV (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
115876|NCT01909804|O9|Outcome|SOF+VEL 25 mg (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
115877|NCT01909804|O8|Outcome|SOF+VEL 100 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
115878|NCT01909804|O7|Outcome|SOF+VEL 100 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
115879|NCT01909804|O6|Outcome|SOF+VEL 25 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
115880|NCT01909804|O5|Outcome|SOF+VEL 25 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
115881|NCT01909804|O4|Outcome|SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
115882|NCT01909804|O3|Outcome|SOF+VEL 100 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
115883|NCT01909804|O2|Outcome|SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
115884|NCT01909804|O1|Outcome|SOF+VEL 25 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
115885|NCT01909804|O4|Outcome|SOF+VEL 100 mg + RBV|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotypes 1 and 3)
115886|NCT01909804|O3|Outcome|SOF+VEL 100 mg|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)
115887|NCT01909804|O2|Outcome|SOF+VEL 25 mg + RBV|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotypes 1 and 3)
115888|NCT01909804|O1|Outcome|SOF+VEL 25 mg|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)
115889|NCT01909804|O12|Outcome|SOF+VEL 100 mg + RBV (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
115890|NCT01909804|O11|Outcome|SOF+VEL 100 mg (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
115891|NCT01909804|O10|Outcome|SOF+VEL 25 mg + RBV (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
115892|NCT01909804|O9|Outcome|SOF+VEL 25 mg (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
115893|NCT01909804|O8|Outcome|SOF+VEL 100 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
115894|NCT01909804|O7|Outcome|SOF+VEL 100 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
115895|NCT01909804|O6|Outcome|SOF+VEL 25 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
115896|NCT01909804|O5|Outcome|SOF+VEL 25 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
115897|NCT01909804|O4|Outcome|SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
115898|NCT01909804|O3|Outcome|SOF+VEL 100 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
115899|NCT01909804|O2|Outcome|SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
115900|NCT01909804|O1|Outcome|SOF+VEL 25 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
115901|NCT01909804|E4|Reported Event|SOF+VEL 100 mg + RBV|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotypes 1 and 3)
115902|NCT01909804|E3|Reported Event|SOF+VEL 100 mg|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)
115903|NCT01909804|E2|Reported Event|SOF+VEL 25 mg + RBV|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotypes 1 and 3)
115904|NCT01909804|E1|Reported Event|SOF+VEL 25 mg|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)
115905|NCT01909778|B1|Baseline|All Subjects|"The trial was a nonrandomised, open-label, 2-period fixed-sequence trial to evaluate two single oral doses of Faldaprevir, separated by 14 days washout period. The dose levels were 120 mg and 240 mg.~A number of 12 entered patients with compensated liver cirrhosis was planned."
115906|NCT01909778|P1|Participant Flow|All Subjects|"The trial was a nonrandomised, open-label, 2-period fixed-sequence trial to evaluate two single oral doses of Faldaprevir, separated by 14 days washout period. The dose levels were 120 mg first, 240 mg second.~A number of 12 entered patients with compensated liver cirrhosis was planned."
115907|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
115908|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
115909|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
119638|NCT01890148|E1|Reported Event|AZD5069|AZD5069 45mg oral twice daily (BID)
115910|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
115911|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
115912|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
115913|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
115914|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
115915|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
115916|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
115917|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
115918|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
115919|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
115920|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
115921|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
115922|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
115923|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
115924|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
115925|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
115926|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
115927|NCT01909778|E2|Reported Event|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
115928|NCT01909778|E1|Reported Event|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
115929|NCT01909713|B1|Baseline|Cetaphil® DermaControl™ Regimen.|"All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days.~Facial Cleanser and Moisturizer SPF 30: Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30"
115930|NCT01909713|P1|Participant Flow|Cetaphil® DermaControl™ Regimen.|"All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days.~Facial Cleanser and Moisturizer SPF 30: Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30"
115931|NCT01909713|O6|Outcome|I Liked the Lotion Better Than What I Was Using Before|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22). Subjects were only required to respond to this question if they had used a moisturizer previously.
115932|NCT01909713|O5|Outcome|I Would Keep Using the Lotion|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
115933|NCT01909713|O4|Outcome|The Lotion Made my Skin Feel Soft|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
115934|NCT01909713|O3|Outcome|The Lotion Spread Easily on my Skin|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
115935|NCT01909713|O2|Outcome|The Lotion Smelled Good|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
115936|NCT01909713|O1|Outcome|I Liked Using the Lotion|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
115937|NCT01909713|O6|Outcome|I Liked the Face Wash Better Than What I Was Using Before|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22). Subjects were only required to respond to this question if they had used a face wash previously.
115938|NCT01909713|O5|Outcome|I Would Keep Using the Face Wash|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
115939|NCT01909713|O4|Outcome|The Face Wash Rinsed Easily Off my Skin|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
115940|NCT01909713|O3|Outcome|The Face Wash Made my Skin Feel Clean|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
115941|NCT01909713|O2|Outcome|The Face Wash Was Easy to Use|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
115995|NCT01909570|P1|Participant Flow|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
115942|NCT01909713|O1|Outcome|I Liked Using the Face Wash|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
115943|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Hydration as assessed using corneometry at baseline, week 1, and week 3. This arm shows the results from week 3.
115944|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Hydration as assessed using corneometry at baseline, week 1, and week 3.This arm shows the results from week 1.
115945|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Hydration as assessed using corneometry at baseline, week 1, and week 3. This arm shows the results from baseline.
115946|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. TEWL was assessed at baseline, week 1, and week 3. This arm shows the results from week 3.
115947|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days, TEWL was assessed at baseline, week 1, and week 3. This arm shows the results from week 1.
115948|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. TEWL was assessed at baseline, week 1, and week 3. This arm shows the results from baseline.
115949|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
115950|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
115951|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
115952|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
115953|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
115954|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
115955|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
115956|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
115957|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
115958|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
115959|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
115960|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
115961|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
115962|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
115963|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
115964|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
115996|NCT01909570|O2|Outcome|Double Embryo Transfer|Transfer of two fresh embryos
115965|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
115966|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
115967|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
115968|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
115969|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
115970|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
115971|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
115972|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
115973|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
115974|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
115975|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
115976|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
115977|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
115978|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
115979|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
115980|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
115981|NCT01909713|E1|Reported Event|Cetaphil® DermaControl™ Regimen.|"All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days.~Facial Cleanser and Moisturizer SPF 30: Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30"
115982|NCT01909674|B3|Baseline|Total|Total of all reporting groups
115983|NCT01909674|B2|Baseline|Nasal Mask|"Initial administration of nasal CPAP mask~Switch CPAP mask type"
115984|NCT01909674|B1|Baseline|Oronasal Mask|"Initial administration of oronasal CPAP mask~Switch CPAP mask type"
115985|NCT01909674|P2|Participant Flow|Nasal Mask|"Initial administration of nasal CPAP mask~Switch CPAP mask type"
115986|NCT01909674|P1|Participant Flow|Oronasal Mask|"Initial administration of oronasal CPAP mask~Switch CPAP mask type"
115987|NCT01909674|O2|Outcome|Total Sleep Time (TST) Oronasal Mask|"Total Sleep Time (TST)~The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode."
115988|NCT01909674|O1|Outcome|Total Sleep Time - Nasal Mask|"Total Sleep Time (TST)~The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode."
115989|NCT01909674|E2|Reported Event|Nasal Mask|"Initial administration of nasal CPAP mask~Switch CPAP mask type"
115990|NCT01909674|E1|Reported Event|Oronasal Mask|"Initial administration of oronasal CPAP mask~Switch CPAP mask type"
115991|NCT01909570|B3|Baseline|Total|Total of all reporting groups
115992|NCT01909570|B2|Baseline|Double Embryo Transfer|Transfer of two fresh embryos
115993|NCT01909570|B1|Baseline|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
115994|NCT01909570|P2|Participant Flow|Double Embryo Transfer|Transfer of two fresh embryos
115997|NCT01909570|O1|Outcome|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
115998|NCT01909570|O2|Outcome|Double Embryo Transfer|Transfer of two fresh embryos
115999|NCT01909570|O1|Outcome|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
116000|NCT01909570|O2|Outcome|Double Embryo Transfer|Transfer of two fresh embryos
116001|NCT01909570|O1|Outcome|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
116002|NCT01909570|E2|Reported Event|Double Embryo Transfer|Transfer of two fresh embryos
116003|NCT01909570|E1|Reported Event|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
116004|NCT01909466|B1|Baseline|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
116005|NCT01909466|P2|Participant Flow|Deltoid/Deltoid|Participants were injected with aripiprazole IM depot 400 mg at the deltoid muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
116006|NCT01909466|P1|Participant Flow|Gluteal/Deltoid|Participants were injected with aripiprazole IM depot 400 mg at the gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
116007|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
116008|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
116009|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
116010|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
116011|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
116012|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
116013|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
116014|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
116015|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
116016|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
116017|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
116018|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
116019|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
116020|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
116021|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
116022|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
116023|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
116024|NCT01909466|E1|Reported Event|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
116025|NCT01909336|B4|Baseline|Total|Total of all reporting groups
116026|NCT01909336|B3|Baseline|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|"Group 3: 0.9% Saline in 5% dextrose (intravenous)~0.9% Saline in 5% dextrose: Isotonic Solutions 0.9% Saline in 5% dextrose"
116027|NCT01909336|B2|Baseline|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|"Group 2: 0.45% Saline in 5% dextrose (intravenous)~0.45% Saline in 5% dextrose: Hypotonic Solutions: 0.45% Saline in 5% dextrose"
116028|NCT01909336|B1|Baseline|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|"Group 1: 0.3% Saline in 3.3% dextrose (intravenous)~0.3% Saline in 3.3% dextrose: Hypotonic Solutions: 0.3% Saline in 3.3% dextrose"
116029|NCT01909336|P3|Participant Flow|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
116030|NCT01909336|P2|Participant Flow|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
119639|NCT01890122|B5|Baseline|Total|Total of all reporting groups
116031|NCT01909336|P1|Participant Flow|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
116032|NCT01909336|O3|Outcome|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
116033|NCT01909336|O2|Outcome|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
116034|NCT01909336|O1|Outcome|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
116035|NCT01909336|O3|Outcome|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
116036|NCT01909336|O2|Outcome|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
116037|NCT01909336|O1|Outcome|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
116038|NCT01909336|O3|Outcome|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
116039|NCT01909336|O2|Outcome|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
116040|NCT01909336|O1|Outcome|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
116041|NCT01909336|E3|Reported Event|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
116042|NCT01909336|E2|Reported Event|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
116043|NCT01909336|E1|Reported Event|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
116044|NCT01909180|B1|Baseline|Standard of Care Scan|"This is a single arm clinical trial.~Standard of care scan~Investigational Scan"
116045|NCT01909180|P1|Participant Flow|Standard of Care Scan|"This is a single arm clinical trial.~Standard of care scan~Investigational Scan"
116046|NCT01909180|O3|Outcome|Neuro|Subjects receiving Revolution CT Scans of Brain or Spinal Cord
116047|NCT01909180|O2|Outcome|Body/ Extremity|Subject receiving a Revolution CT scan of the body or extremities
116048|NCT01909180|O1|Outcome|Cardiac|Subjects who received a cardiac CT scan
116049|NCT01909180|E1|Reported Event|Standard of Care Scan|"This is a single arm clinical trial.~Standard of care scan~Investigational Scan"
116050|NCT01909141|B3|Baseline|Total|Total of all reporting groups
116051|NCT01909141|B2|Baseline|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 will received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occured.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
116052|NCT01909141|B1|Baseline|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
116053|NCT01909141|P2|Participant Flow|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
116054|NCT01909141|P1|Participant Flow|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
116078|NCT01909011|E2|Reported Event|Sham|Participants received sham CES (device off) for 20 minutes 5 times per week for two weeks (placebo period), and after cross-over into open-label phase participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for another two weeks.
116079|NCT01909011|E1|Reported Event|Active|Participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for four weeks.
116080|NCT01908907|B3|Baseline|Total|Total of all reporting groups
116055|NCT01909141|O2|Outcome|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
116056|NCT01909141|O1|Outcome|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
116057|NCT01909141|O2|Outcome|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
116058|NCT01909141|O1|Outcome|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
116059|NCT01909141|O2|Outcome|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
116060|NCT01909141|O1|Outcome|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
116061|NCT01909141|O2|Outcome|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
116081|NCT01908907|B2|Baseline|Placebo Supplemented|Preterm infants (29) randomized to receive placebo study oil
116082|NCT01908907|B1|Baseline|DHA Supplemented|Preterm infants (31) randomized to receive 50mg/d of enteral DHA supplementation
116083|NCT01908907|P2|Participant Flow|Medium Chain Triglyceride (MCT) Control Oil|"MCT oil administered 0.18ml as an oil emulsion enterally with feedings or by gavage tube if the infant has one.~Placebo Group:MCT oil administered at 0.18 ml as an oil emulsion"
116084|NCT01908907|P1|Participant Flow|DHA Oil|"DHA oil administered 50 mg/d (0.18ml)as an oil emulsion enterally with feedings or by gavage tube if the infant has one.~DHA oil administered at 50 mg/d (0.18ml) Or MCT oil administered at 0.18 ml"
116062|NCT01909141|O1|Outcome|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
116063|NCT01909141|O2|Outcome|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occured.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
116064|NCT01909141|O1|Outcome|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 receivde letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was be done for arm 1 for 3 consecutive cycles unless pregnancy occured.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was caculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
116065|NCT01909141|E2|Reported Event|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
116066|NCT01909141|E1|Reported Event|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
116067|NCT01909011|B3|Baseline|Total|Total of all reporting groups
116068|NCT01909011|B2|Baseline|Sham CES|"The CES sham group will receive sham CES (device off)for 20 minutes 5 times per week for two weeks.~Sham CES via FW-100 Fisher Wallace Stimulator: The CES sham group will receive sham CES (device off) for 20 minutes 5 times per week for two weeks."
116069|NCT01909011|B1|Baseline|Active CES|"The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks.~FW -100 Fisher Wallace Cranial Electrical Stimulator: The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks."
116070|NCT01909011|P2|Participant Flow|Sham CES|"The CES sham group will receive sham CES (device off) for 20 minutes 5 times per week for two weeks.~Sham CES via FW-100 Fisher Wallace Stimulator: The CES sham group will receive sham CES (device off) for 20 minutes 5 times per week for two weeks."
116071|NCT01909011|P1|Participant Flow|Active CES|"The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks.~FW -100 Fisher Wallace Cranial Electrical Stimulator: The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks."
116072|NCT01909011|O2|Outcome|Sham|Participants received sham CES (device off) for 20 minutes 5 times per week for two weeks.
116073|NCT01909011|O1|Outcome|Active|Participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for two weeks.
116074|NCT01909011|O2|Outcome|Sham|Participants received sham CES (device off) for 20 minutes 5 times per week for two weeks.
116075|NCT01909011|O1|Outcome|Active|Participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for two weeks.
116076|NCT01909011|O2|Outcome|Sham|Participants received sham CES (device off) for 20 minutes 5 times per week for two weeks.
116077|NCT01909011|O1|Outcome|Active|Participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for two weeks.
116085|NCT01908907|O2|Outcome|MCT (Placebo Control Group)|"Preterm infants receiving 0.18 ml of MCT (control oil) from the first week of life until term GA or discharge, whichever came first.~LCPUFA levels were measured at baseline, after reaching full enteral feedings and at discharge or term GA, whichever came first."
116086|NCT01908907|O1|Outcome|DHA Supplemented|"Preterm infants supplemented with 50mg/d (0.18ml) of enteral DHA from the first week of life until term GA or discharge, whichever came first.~LCPUFA levels were measured at baseline, after reaching full enteral feedings and at discharge or term GA, whichever came first."
116087|NCT01908907|O2|Outcome|MCT (Placebo Control Group)|"Preterm infants receiving 0.18 ml of MCT (control oil) from the first week of life until term GA or discharge, whichever came first.~LCPUFA levels were measured at baseline, after reaching full enteral feedings and at discharge or term GA, whichever came first."
116088|NCT01908907|O1|Outcome|DHA Supplemented|"Preterm infants supplemented with 50mg/d (0.18ml) of enteral DHA from the first week of life until term GA or discharge, whichever came first.~LCPUFA levels were measured at baseline, after reaching full enteral feedings and at discharge or term GA, whichever came first."
116089|NCT01908907|O2|Outcome|MCT (Placebo Control Group)|"Preterm infants receiving 0.18 ml of MCT (control oil) from the first week of life until term GA or discharge, whichever came first.~LCPUFA levels were measured at baseline, after reaching full enteral feedings and at discharge or term GA, whichever came first."
116090|NCT01908907|O1|Outcome|DHA Supplemented|"Preterm infants supplemented with 50mg/d (0.18ml) of enteral DHA from the first week of life until term GA or discharge, whichever came first.~LCPUFA levels were measured at baseline, after reaching full enteral feedings and at discharge or term GA, whichever came first."
116091|NCT01908907|O2|Outcome|MCT (Placebo Control Group)|Preterm infants receiving 0.18 ml of MCT (control oil) from the first week of life until term GA or discharge, whichever came first.
116092|NCT01908907|O1|Outcome|DHA Supplemented|Preterm infants supplemented with 50mg/d (0.18ml) of enteral DHA from the first week of life until term GA or discharge, whichever came first.
116093|NCT01908907|O2|Outcome|MCT (Placebo Control Group)|Preterm infants receiving 0.18 ml of MCT (control oil) from the first week of life until term GA or discharge, whichever came first.
116094|NCT01908907|O1|Outcome|DHA Supplemented|Preterm infants supplemented with 50mg/d (0.18ml) of enteral DHA from the first week of life until term GA or discharge, whichever came first.
116095|NCT01908907|O2|Outcome|MCT (Placebo Control Group)|"Preterm infants receiving 0.18 ml of MCT (control oil) from the first week of life until term GA or discharge, whichever came first.~LCPUFA levels were measured at baseline, after reaching full enteral feedings and at discharge or term GA, whichever came first."
116096|NCT01908907|O1|Outcome|DHA Supplemented|"Preterm infants supplemented with 50mg/d (0.18ml) of enteral DHA from the first week of life until term GA or discharge, whichever came first.~LCPUFA levels were measured at baseline, after reaching full enteral feedings and at discharge or term GA, whichever came first."
116097|NCT01908907|O2|Outcome|MCT (Placebo Control Group)|Preterm infants receiving 0.18 ml of MCT (control oil) from the first week of life until term GA or discharge, whichever came first.
116098|NCT01908907|O1|Outcome|DHA Supplemented|Preterm infants supplemented with 50mg/d (0.18ml) of enteral DHA from the first week of life until term GA or discharge, whichever came first.
116099|NCT01908907|O2|Outcome|(MCT) Control Oil|"MCT oil administered 0.18ml as an oil emulsion enterally with feedings or by gavage tube if the infant has one.~Placebo Group:MCT oil administered at 0.18 ml as an oil emulsion"
116100|NCT01908907|O1|Outcome|DHA Oil|"DHA oil administered 50 mg/d (0.18ml)as an oil emulsion enterally with feedings or by gavage tube if the infant has one.~DHA oil administered at 50 mg/d (0.18ml) Or MCT oil administered at 0.18 ml"
116101|NCT01908907|E2|Reported Event|(MCT) Control Oil|"MCT oil administered 0.18ml as an oil emulsion enterally with feedings or by gavage tube if the infant has one.~Placebo Group:MCT oil administered at 0.18 ml as an oil emulsion"
116102|NCT01908907|E1|Reported Event|DHA Oil|"DHA oil administered 50 mg/d (0.18ml)as an oil emulsion enterally with feedings or by gavage tube if the infant has one.~DHA oil administered at 50 mg/d (0.18ml) Or MCT oil administered at 0.18 ml"
116103|NCT01908842|B3|Baseline|Total|Total of all reporting groups
116104|NCT01908842|B2|Baseline|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Generic buprenorphine sublingual tablets (blinded); Days 3 to 14: BNX sublingual film (open-label); Days 15-21: Switch to BNX sublingual tablets (open-label); Day 22: End of study visit
116105|NCT01908842|B1|Baseline|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded); Days 3-14: BNX sublingual tablets (open-label); Days 15-21: Switch to BNX sublingual film (open-label); Day 22: End of study visit
116106|NCT01908842|P2|Participant Flow|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
116107|NCT01908842|P1|Participant Flow|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3 to 14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
116108|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
116109|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
116110|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
116111|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
116348|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116112|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
116113|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
116114|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
116115|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
116116|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
116117|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
116118|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
116119|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
116120|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
116121|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
116122|NCT01908842|E2|Reported Event|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
116123|NCT01908842|E1|Reported Event|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
116124|NCT01908829|B4|Baseline|Total|Total of all reporting groups
116125|NCT01908829|B3|Baseline|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116126|NCT01908829|B2|Baseline|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116127|NCT01908829|B1|Baseline|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116128|NCT01908829|P3|Participant Flow|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116129|NCT01908829|P2|Participant Flow|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116130|NCT01908829|P1|Participant Flow|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116131|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116132|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116133|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116134|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116135|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116136|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116137|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116138|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116139|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116140|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116141|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116142|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116143|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116144|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116145|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116146|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116147|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116148|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116149|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116349|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116350|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116150|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116151|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116152|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116153|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116154|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116155|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116156|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116157|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116158|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116159|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116160|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116161|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116162|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116163|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116164|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116165|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116166|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116351|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116352|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116167|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116168|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116169|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116170|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116171|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116172|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116173|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116174|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116175|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116176|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116177|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116178|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116179|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116180|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116181|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116182|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116183|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116353|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116354|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116184|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116185|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116186|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116187|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116188|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116189|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116190|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116191|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116192|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116193|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116194|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116195|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116196|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116197|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116198|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116199|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116200|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116355|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116356|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116201|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116202|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116203|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116204|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116205|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116206|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116207|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116208|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116209|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116210|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116211|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116212|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116213|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116214|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116215|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116216|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116217|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116357|NCT01907906|E2|Reported Event|Untreated Control|LR-pRBCs derived from untreated WB
116358|NCT01907906|E1|Reported Event|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB.
116218|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116219|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116220|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116221|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116222|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116223|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116224|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116225|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116226|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116227|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116228|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116229|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116230|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116231|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116232|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116233|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116234|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116359|NCT01907854|B3|Baseline|Total|Total of all reporting groups
116388|NCT01907815|O1|Outcome|Trametinib 2.0 mg + GSK2141795 25 mg|Trametinib 2.0 mg PO QD + GSK2141795 25 mg PO QD on days 1-28.
116235|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116236|NCT01908829|O3|Outcome|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116237|NCT01908829|O2|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116238|NCT01908829|O1|Outcome|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116239|NCT01908829|E3|Reported Event|Solifenacin 10 mg|Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
116240|NCT01908829|E2|Reported Event|Solifenacin 5 mg|Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
116241|NCT01908829|E1|Reported Event|Combination (Solifenacin + Mirabegron)|Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
116242|NCT01908803|B3|Baseline|Total|Total of all reporting groups
116243|NCT01908803|B2|Baseline|CIPRODEX|Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
116244|NCT01908803|B1|Baseline|AL-60371/AL-817|200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
116245|NCT01908803|P2|Participant Flow|CIPRODEX|Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
116246|NCT01908803|P1|Participant Flow|AL-60371/AL-817|200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
116247|NCT01908803|O2|Outcome|CIPRODEX|Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
116248|NCT01908803|O1|Outcome|AL-60371/AL-817|200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
116249|NCT01908803|O2|Outcome|CIPRODEX|Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
116250|NCT01908803|O1|Outcome|AL-60371/AL-817|200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
116251|NCT01908803|O2|Outcome|CIPRODEX|Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
116252|NCT01908803|O1|Outcome|AL-60371/AL-817|200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
116253|NCT01908803|E3|Reported Event|CIPRODEX|Includes all subjects administered a dose of CIPRODEX®
116254|NCT01908803|E2|Reported Event|AL-60371/AL-817|Includes all subjects administered a dose of AL-60371/AL-817
116255|NCT01908803|E1|Reported Event|Pre-treatment|Includes all subjects prior to administration of study medication
116256|NCT01908140|B3|Baseline|Total|Total of all reporting groups
116257|NCT01908140|B2|Baseline|Salmeterol / Fluticasone|Active Comparator: Salmeterol / Fluticasone propionate Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
116258|NCT01908140|B1|Baseline|Aclidinium Bromide / Formoterol Fumarate|Experimental: Aclidinium Bromide / Formoterol Fumarate Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
116259|NCT01908140|P2|Participant Flow|Salmeterol / Fluticasone|Active Comparator: Salmeterol / Fluticasone propionate Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
116260|NCT01908140|P1|Participant Flow|Aclidinium Bromide / Formoterol Fumarate|Experimental: Aclidinium Bromide / Formoterol Fumarate Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
116261|NCT01908140|O2|Outcome|Salmeterol / Fluticasone|Active Comparator: Salmeterol / Fluticasone propionate Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
116262|NCT01908140|O1|Outcome|Aclidinium Bromide / Formoterol Fumarate|Experimental: Aclidinium Bromide / Formoterol Fumarate Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
116263|NCT01908140|O2|Outcome|Salmeterol / Fluticasone|Active Comparator: Salmeterol / Fluticasone propionate Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
116264|NCT01908140|O1|Outcome|Aclidinium Bromide / Formoterol Fumarate|Experimental: Aclidinium Bromide / Formoterol Fumarate Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
116265|NCT01908140|E2|Reported Event|Salmeterol / Fluticasone|Active Comparator: Salmeterol / Fluticasone propionate Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
116266|NCT01908140|E1|Reported Event|Aclidinium Bromide / Formoterol Fumarate|Experimental: Aclidinium Bromide / Formoterol Fumarate Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
116267|NCT01908127|B3|Baseline|Total|Total of all reporting groups
116360|NCT01907854|B2|Baseline|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
116389|NCT01907815|O2|Outcome|Trametinib 1.5 mg + GSK2141795 50 mg|Trametinib 1.5 mg PO QD + GSK2141795 50 mg PO QD on days 1-28.
116268|NCT01908127|B2|Baseline|Film Modelling|"Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.~In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
116269|NCT01908127|B1|Baseline|Tell- Show- do Procedure|"Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.~In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
116270|NCT01908127|P2|Participant Flow|Film Modelling|"Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.~In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
116271|NCT01908127|P1|Participant Flow|Tell- Show- do Procedure|"Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.~In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
116272|NCT01908127|O2|Outcome|Film Modelling|"Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.~In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
116273|NCT01908127|O1|Outcome|Tell- Show- do Procedure|"Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.~In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
116274|NCT01908127|O2|Outcome|Film Modelling|"Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.~In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
116275|NCT01908127|O1|Outcome|Tell- Show- do Procedure|"Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.~In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
116276|NCT01908127|E2|Reported Event|Film Modelling|"Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.~In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
116277|NCT01908127|E1|Reported Event|Tell- Show- do Procedure|"Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.~In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
116278|NCT01907906|B3|Baseline|Total|Total of all reporting groups
116279|NCT01907906|B2|Baseline|Arm 2: Untreated WB Then Mirasol-treated WB|Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB UNTREATED on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49)
116280|NCT01907906|B1|Baseline|Arm 1: Mirasol-treated WB Then Untreated WB|Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49
116281|NCT01907906|P2|Participant Flow|Arm 2: Untreated WB Then Mirasol-treated WB|Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49
116361|NCT01907854|B1|Baseline|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
116390|NCT01907815|O1|Outcome|Trametinib 2.0 mg + GSK2141795 25 mg|Trametinib 2.0 mg PO QD + GSK2141795 25 mg PO QD on days 1-28.
116282|NCT01907906|P1|Participant Flow|Arm 1: Mirasol-treated Whole Blood (WB) Then Untreated WB|Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, leuko-reduced packed red blood cells (LR-pRBCs) manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49
116283|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116284|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116285|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116286|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116287|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116288|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116289|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116290|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116291|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116292|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116293|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116294|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116295|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116296|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116297|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116298|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116299|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116300|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116301|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116302|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116303|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116304|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116305|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116306|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116307|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116308|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116309|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116310|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116311|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116312|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116313|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116314|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116315|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116316|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116317|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116318|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116319|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116320|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116321|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116322|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116323|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116324|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116325|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116326|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116327|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116328|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116329|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116330|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116331|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116332|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116333|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116334|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116335|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116336|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116337|NCT01907906|O2|Outcome|Untreated Control|Leuko-Reduced packed Red Blood Cells (LR-pRBCs) derived from untreated WB
116338|NCT01907906|O1|Outcome|Mirasol Treated|Leuko-Reduced packed Red Blood Cells (LR-pRBCs) derived from Mirasol-treated WB
116339|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116340|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116341|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116342|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116343|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116344|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116345|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
116346|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
116347|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
136502|NCT01806857|O2|Outcome|Matching Placebo|
116362|NCT01907854|P2|Participant Flow|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
116363|NCT01907854|P1|Participant Flow|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
116364|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
116365|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
116366|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
116367|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
116368|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
116369|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
116370|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
116371|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
116372|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
116373|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
116374|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
116375|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
116376|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
116377|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
116378|NCT01907854|E2|Reported Event|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
116379|NCT01907854|E1|Reported Event|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
116380|NCT01907815|B3|Baseline|Total|Total of all reporting groups
116381|NCT01907815|B2|Baseline|Trametinib 1.5 mg + GSK2141795 50 mg|Trametinib 1.5 mg PO QD + GSK2141795 50 mg PO QD on days 1-28.
116382|NCT01907815|B1|Baseline|Trametinib 2.0 mg + GSK2141795 25 mg|Trametinib 2.0 mg PO QD + GSK2141795 25 mg PO QD on days 1-28.
116383|NCT01907815|P2|Participant Flow|Trametinib 1.5 mg + GSK2141795 50 mg|Trametinib 1.5 mg PO QD + GSK2141795 50 mg PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
116384|NCT01907815|P1|Participant Flow|Trametinib 2.0 mg + GSK2141795 25 mg|Trametinib 2.0 mg orally once daily (PO QD) and Akt inhibitor GSK2141795 25 mg PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
116385|NCT01907815|O2|Outcome|Trametinib 1.5 mg + GSK2141795 50 mg|Trametinib 1.5 mg PO QD + GSK2141795 50 mg PO QD on days 1-28.
116386|NCT01907815|O1|Outcome|Trametinib 2.0 + GSK2141795 25 mg|Trametinib 2.0 mg PO QD + GSK2141795 25 mg PO QD on days 1-28.
116387|NCT01907815|O2|Outcome|Trametinib 1.5 mg + GSK2141795 50 mg|Trametinib 1.5 mg PO QD + GSK2141795 50 mg PO QD on days 1-28.
116391|NCT01907815|O2|Outcome|Trametinib 1.5 mg + GSK2141795 50 mg|Trametinib 1.5 mg PO QD + GSK2141795 50 mg PO QD on days 1-28.
116392|NCT01907815|O1|Outcome|Trametinib 2.0 + GSK2141795 25 mg|Trametinib 2.0 mg PO QD + GSK2141795 25 mg PO QD on days 1-28.
116393|NCT01907815|O2|Outcome|Trametinib 1.5 mg + GSK2141795 50 mg|Trametinib 1.5 mg PO QD + GSK2141795 50 mg PO QD on days 1-28.
116394|NCT01907815|O1|Outcome|Trametinib 2.0 mg + GSK2141795 25 mg|Trametinib 2.0 mg PO QD & GSK2141795 25 mg PO QD on days 1-28.
116395|NCT01907815|E2|Reported Event|Trametinib 1.5 mg + GSK2141795 50 mg|Trametinib 1.5 mg PO QD + GSK2141795 50 mg PO QD on days 1-28.
116396|NCT01907815|E1|Reported Event|Trametinib 2.0 mg + GSK2141795 25 mg|Trametinib 2.0 mg PO QD + GSK2141795 25 mg PO QD on days 1-28.
116397|NCT01907516|B3|Baseline|Total|Total of all reporting groups
116398|NCT01907516|B2|Baseline|Voicemail First, Then Cell Phone-internet|Voicemail home blood glucose reporting first
116399|NCT01907516|B1|Baseline|Cell Phone-internet First, the Voicemail|Cell phone-internet home glucose reporting system first
116400|NCT01907516|P2|Participant Flow|Voicemail First, Then Cell Phone-internet|Voicemail home blood glucose reporting first, then cell phone-internet
116401|NCT01907516|P1|Participant Flow|Cell Phone-internet First, Then Voicemail|Cell phone-internet home glucose reporting system first, then voicemail
116402|NCT01907516|O1|Outcome|Total Study Population|All study participants, includes those in cell phone-internet first, then voicemail and voicemail first, then cell phone-internet
116403|NCT01907516|O2|Outcome|Used Voicemail Method|Voicemail first, then cell phone-internet home glucose monitoring system
116404|NCT01907516|O1|Outcome|Used Confidant Method|Cell phone-internet home based glucose monitoring first, then conventional Voicemail system for home glucose reporting
116405|NCT01907516|E2|Reported Event|Voicemail First, Then Cell Phone-internet|Voicemail home blood glucose reporting first
116406|NCT01907516|E1|Reported Event|Cell Phone-internet First, Then Voicemail|Cell phone-internet home glucose reporting system first
116407|NCT01907490|B1|Baseline|Ha44 Gel 0.74% w/w|Ha44 Gel 0.74% w/w Open label, one arm
116408|NCT01907490|P1|Participant Flow|Ha44 Gel 0.74% w/w|Ha44 Gel 0.74% w/w Open label, one arm
116409|NCT01907490|O1|Outcome|Ha44 Gel 0.74% w/w|Ha44 Gel 0.74% w/w Open label, one arm
116410|NCT01907490|E1|Reported Event|Ha44 Gel 0.74% w/w|Ha44 Gel 0.74% w/w Open label, one arm
116411|NCT01907334|B1|Baseline|All Participants|Participants were randomized to either Advair 100/50 mcg and Advair 100/50 mcg, then Advair 100/50 mcg and Flovent 100 mcg OR Advair 100/50 mcg and Flovent 100 mcg, then Advair 100/50 mcg and Advair 100/50 mcg.
116412|NCT01907334|P2|Participant Flow|Advair and Flovent Diskuses, Then Advair and Advair Diskuses|"On treatment day one, Advair 100/50 mcg and Flovent 100 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5.~On treatment day two, Advair 100/50 mcg and Advair 100/50 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5."
116413|NCT01907334|P1|Participant Flow|Advair and Advair Diskuses, Then Advair and Flovent Diskuses|"On treatment day one, Advair 100/50 mcg and Advair 100/50 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5.~On treatment day two, Advair 100/50 mcg and Flovent 100 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5."
116414|NCT01907334|O1|Outcome|Increase in Airway Resistance After Methacholine|Participants were randomized to either Advair 100/50 mcg and Advair 100/50 mcg, then Advair 100/50 mcg and Flovent 100 mcg OR Advair 100/50 mcg and Flovent 100 mcg, then Advair 100/50 mcg and Advair 100/50 mcg. On each study day after treatment, methacholine challenge was performed to determine provocational concentration of methacholine which caused a 40% increase in resistance at 5 Hz (PC40R5).
116415|NCT01907334|E2|Reported Event|Advair and Flovent Diskuses, Then Advair and Advair Diskuses|"On treatment day one, Advair 100/50 mcg and Flovent 100 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5.~On treatment day two, Advair 100/50 mcg and Advair 100/50 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5."
116428|NCT01907113|P5|Participant Flow|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
116429|NCT01907113|P4|Participant Flow|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116430|NCT01907113|P3|Participant Flow|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116416|NCT01907334|E1|Reported Event|Advair and Advair Diskuses, Then Advair and Flovent Diskuses|"On treatment day one, Advair 100/50 mcg and Advair 100/50 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5.~On treatment day two, Advair 100/50 mcg and Flovent 100 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5."
116417|NCT01907321|B1|Baseline|Expiratory Muscle Strength Training (EMST)|"Participants will complete 5 weeks of EMST training, 5 repetitions per set, 5 sets per day, 5 days per week.~Expiratory muscle strength training: Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure.~Measures: Capsaicin will be used to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, and expiratory phase airflow will be made.~Pulmonary function test: Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Airflow from the voluntary cough will also be recorded and measured using the spirometric system. These measures will be identical to those made on the capsaicin-induced cough.~Fluoroscopic swallow study: Images from the swallow study will be used to determine the modified barium swallow impairment profile (MBSImp) score, as well as the penetration-aspiration score (PA)."
116418|NCT01907321|P1|Participant Flow|Expiratory Muscle Strength Training (EMST)|"Participants will complete 5 weeks of EMST training, 5 repetitions per set, 5 sets per day, 5 days per week.~Expiratory muscle strength training: Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure. Once sufficient pressure is achieved (participant blowing out into the device) a valve is released, enabling airflow.~Measures performed on all subjects: Capsaicin is a cough-inducing vapor that will be inhaled by participants to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, peak expiratory flow rate, and post-peak plateau phase will be made.~Pulmonary function test: Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Also included is the measure of maximum expiratory pressure. Airflow from the voluntary cough will also be recorded and measured using the spirometric system."
116419|NCT01907321|O1|Outcome|Expiratory Muscle Strength Training (EMST)|"Participants will complete 5 weeks of EMST training, 5 repetitions per set, 5 sets per day, 5 days per week.~Expiratory muscle strength training: Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure.~Measures: Capsaicin will be used to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, and expiratory phase airflow will be made.~Pulmonary function test: Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Airflow from the voluntary cough will also be recorded and measured using the spirometric system. These measures will be identical to those made on the capsaicin-induced cough.~Fluoroscopic swallow study: Images from the swallow study will be used to determine the modified barium swallow impairment profile (MBSImp) score, as well as the penetration-aspiration score (PA)."
116420|NCT01907321|O1|Outcome|Expiratory Muscle Strength Training (EMST)|"Participants will complete 5 weeks of EMST training, 5 repetitions per set, 5 sets per day, 5 days per week.~Expiratory muscle strength training: Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure.~Measures: Capsaicin will be used to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, and expiratory phase airflow will be made.~Pulmonary function test: Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Airflow from the voluntary cough will also be recorded and measured using the spirometric system. These measures will be identical to those made on the capsaicin-induced cough.~Fluoroscopic swallow study: Images from the swallow study will be used to determine the modified barium swallow impairment profile (MBSImp) score, as well as the penetration-aspiration score (PA)."
116421|NCT01907321|E1|Reported Event|Expiratory Muscle Strength Training (EMST)|"Participants will complete 5 weeks of EMST training, 5 repetitions per set, 5 sets per day, 5 days per week.~Expiratory muscle strength training: Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure.~Measures: Capsaicin will be used to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, and expiratory phase airflow will be made.~Pulmonary function test: Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Airflow from the voluntary cough will also be recorded and measured using the spirometric system. These measures will be identical to those made on the capsaicin-induced cough.~Fluoroscopic swallow study: Images from the swallow study will be used to determine the modified barium swallow impairment profile (MBSImp) score, as well as the penetration-aspiration score (PA)."
116422|NCT01907113|B6|Baseline|Total|Total of all reporting groups
116423|NCT01907113|B5|Baseline|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
116424|NCT01907113|B4|Baseline|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116425|NCT01907113|B3|Baseline|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116426|NCT01907113|B2|Baseline|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116427|NCT01907113|B1|Baseline|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116431|NCT01907113|P2|Participant Flow|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116432|NCT01907113|P1|Participant Flow|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116433|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
116434|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116435|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116436|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116437|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116438|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
116439|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116440|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116441|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116442|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116443|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
116444|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116445|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116446|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116447|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116448|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
116449|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116450|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116451|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116452|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116453|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
116454|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116455|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116952|NCT01903876|P1|Participant Flow|General Health Promotion|A 3-hour general mental health web-based program.
116456|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116457|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116458|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
116459|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116460|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116461|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116462|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116463|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
116464|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116465|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116466|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116467|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116468|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
116469|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116470|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116471|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116472|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116473|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
116474|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116475|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116476|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116477|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116478|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
116479|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116480|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
117238|NCT01901588|P2|Participant Flow|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
116481|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116482|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116483|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
116484|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116485|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116486|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116487|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116488|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
116489|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116490|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116491|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116492|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116493|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
116494|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116495|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116496|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116497|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116498|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
116499|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116500|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116501|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116502|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116503|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
116504|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116505|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
117299|NCT01901328|O1|Outcome|CB-5945|0.25 milligrams CB-5945 administered orally BID for a 12-week treatment period
116506|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116507|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116508|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
116509|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116510|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116511|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116512|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116513|NCT01907113|E5|Reported Event|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
116514|NCT01907113|E4|Reported Event|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116515|NCT01907113|E3|Reported Event|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116516|NCT01907113|E2|Reported Event|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116517|NCT01907113|E1|Reported Event|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
116518|NCT01906658|B5|Baseline|Total|Total of all reporting groups
116519|NCT01906658|B4|Baseline|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116520|NCT01906658|B3|Baseline|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116521|NCT01906658|B2|Baseline|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116522|NCT01906658|B1|Baseline|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116523|NCT01906658|P4|Participant Flow|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116524|NCT01906658|P3|Participant Flow|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116525|NCT01906658|P2|Participant Flow|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116526|NCT01906658|P1|Participant Flow|Acthar 80 U (1.0 mL) Subcutaneous (SC) Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116527|NCT01906658|O4|Outcome|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116528|NCT01906658|O3|Outcome|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116529|NCT01906658|O2|Outcome|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116530|NCT01906658|O1|Outcome|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116531|NCT01906658|O4|Outcome|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116532|NCT01906658|O3|Outcome|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
117300|NCT01901328|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
116533|NCT01906658|O2|Outcome|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116534|NCT01906658|O1|Outcome|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116535|NCT01906658|O4|Outcome|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116536|NCT01906658|O3|Outcome|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116537|NCT01906658|O2|Outcome|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116538|NCT01906658|O1|Outcome|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116539|NCT01906658|O4|Outcome|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116540|NCT01906658|O3|Outcome|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116541|NCT01906658|O2|Outcome|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116542|NCT01906658|O1|Outcome|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116543|NCT01906658|E4|Reported Event|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116544|NCT01906658|E3|Reported Event|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116545|NCT01906658|E2|Reported Event|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116546|NCT01906658|E1|Reported Event|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
116547|NCT01906515|B3|Baseline|Total|Total of all reporting groups
116548|NCT01906515|B2|Baseline|Control Group|Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
116549|NCT01906515|B1|Baseline|SpHb Group.|"In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.~Continuous non invasive hemoglobin monitoring arm~Continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry"
116550|NCT01906515|P2|Participant Flow|Control Group|Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
116551|NCT01906515|P1|Participant Flow|SpHb Group.|"In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.~Continuous non invasive hemoglobin monitoring arm~continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry"
116552|NCT01906515|O2|Outcome|Control Group|Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
116553|NCT01906515|O1|Outcome|SpHb Group.|"In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.~Continuous non invasive hemoglobin monitoring arm.~Continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry"
116554|NCT01906515|O2|Outcome|Control Group|Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
116555|NCT01906515|O1|Outcome|SpHb Group.|"In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.~Continuous non invasive hemoglobin monitoring arm~Continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry"
116556|NCT01906515|E2|Reported Event|Control Group|Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
116557|NCT01906515|E1|Reported Event|SpHb Group.|"In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.~Continuous non invasive hemoglobin monitoring arm~Continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry"
116558|NCT01906372|B1|Baseline|Acthar Gel|Acthar Gel (Adrenocorticotropic Hormone Gel)in refractory PM and DM patients using an open label design for 6 months. Study subjects will self-administer subcutaneously H.P. Acthar Gel 80 units (1 ml) twice a week for a period of six months.
116559|NCT01906372|P1|Participant Flow|Acthar Gel|Acthar Gel (Adrenocorticotropic Hormone Gel) 80 units (1 ml) twice a week for a period of six months.
116560|NCT01906372|O1|Outcome|Acthar Gel|Acthar Gel (Adrenocorticotropic Hormone Gel)in refractory PM and DM patients using an open label design for 6 months. 10 active and refractory PM/DM patients were evaluated over a 15 month period, followed by 6 months of additional follow-up for each subject. Study subjects will self-administer subcutaneously H.P. Acthar Gel 80 units (1 ml) twice a week for a period of six months.
116628|NCT01905657|E1|Reported Event|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
116561|NCT01906372|O1|Outcome|Acthar Gel|Acthar Gel (Adrenocorticotropic Hormone Gel) in active and refractory PM and DM patients using an open label design for 6 months. Study subjects self-administered subcutaneously H.P. Acthar Gel 80 units (1 ml) twice a week subcutaneously for a period of six months.
116562|NCT01906372|E1|Reported Event|Acthar Gel|Acthar Gel (Adrenocorticotropic Hormone Gel)in refractory PM and DM patients using an open label design for 6 months. 10 active and refractory PM/DM patients were evaluated over a 15 month period, followed by 6 months of additional follow-up for each subject. Study subjects will self-administer subcutaneously H.P. Acthar Gel 80 units (1 ml) twice a week for a period of six months.
116563|NCT01905956|B3|Baseline|Total|Total of all reporting groups
116564|NCT01905956|B2|Baseline|Placebo|"2 capsules per dose, 3 times daily~Placebo"
116565|NCT01905956|B1|Baseline|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
116566|NCT01905956|P2|Participant Flow|Placebo|"2 capsules per dose, 3 times daily~Placebo"
116567|NCT01905956|P1|Participant Flow|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
116568|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
116569|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
116570|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
116571|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
116572|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
116573|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
116574|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
116575|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
116576|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
116577|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
116578|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
116579|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
116580|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
116581|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
116582|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
116583|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
116584|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
116585|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
116586|NCT01905956|E2|Reported Event|Placebo|"2 capsules per dose, 3 times daily~Placebo"
116587|NCT01905956|E1|Reported Event|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
116588|NCT01905683|B1|Baseline|16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received total doses of 16 to 20 unit per kilogram (U/kg) body weight of IncobotulinumtoxinA (Xeomin) with a maximum of 400 to 500 units per injection treatment via intramuscular injection into spastic muscles on Day 1 of 4 treatment cycles (12 to 16 weeks treatment per each cycle). The higher dose could only be administered to participants with GMFCS-E&R levels I to III.
116589|NCT01905683|P1|Participant Flow|16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received total doses of 16 to 20 unit per kilogram (U/kg) body weight of IncobotulinumtoxinA (Xeomin) with a maximum of 400 to 500 units per injection treatment via intramuscular injection into spastic muscles on Day 1 of 4 treatment cycles (12 to 16 weeks treatment per each cycle). The higher dose could only be administered to participants with gross motor function classification system expanded and revised (GMFCS-E&R) levels I to III.
116590|NCT01905683|O1|Outcome|16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received total doses of 16 to 20 unit per kilogram (U/kg) body weight of IncobotulinumtoxinA (Xeomin) with a maximum of 400 to 500 units per injection treatment via intramuscular injection into spastic muscles on Day 1 of 4 treatment cycles (12 to 16 weeks treatment per each cycle). The higher dose could only be administered to participants with GMFCS-E&R levels I to III.
116591|NCT01905683|O1|Outcome|16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received total doses of 16 to 20 unit per kilogram (U/kg) body weight of IncobotulinumtoxinA (Xeomin) with a maximum of 400 to 500 units per injection treatment via intramuscular injection into spastic muscles on Day 1 of 4 treatment cycles (12 to 16 weeks treatment per each cycle). The higher dose could only be administered to participants with GMFCS-E&R levels I to III.
116592|NCT01905683|O1|Outcome|16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received total doses of 16 to 20 unit per kilogram (U/kg) body weight of IncobotulinumtoxinA (Xeomin) with a maximum of 400 to 500 units per injection treatment via intramuscular injection into spastic muscles on Day 1 of 4 treatment cycles (12 to 16 weeks treatment per each cycle). The higher dose could only be administered to participants with GMFCS-E&R levels I to III.
116593|NCT01905683|O1|Outcome|16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received total doses of 16 to 20 unit per kilogram (U/kg) body weight of IncobotulinumtoxinA (Xeomin) with a maximum of 400 to 500 units per injection treatment via intramuscular injection into spastic muscles on Day 1 of 4 treatment cycles (12 to 16 weeks treatment per each cycle). The higher dose could only be administered to participants with GMFCS-E&R levels I to III.
116594|NCT01905683|O1|Outcome|16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received total doses of 16 to 20 unit per kilogram (U/kg) body weight of IncobotulinumtoxinA (Xeomin) with a maximum of 400 to 500 units per injection treatment via intramuscular injection into spastic muscles on Day 1 of 4 treatment cycles (12 to 16 weeks treatment per each cycle). The higher dose could only be administered to participants with GMFCS-E&R levels I to III.
116595|NCT01905683|O1|Outcome|16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received total doses of 16 to 20 unit per kilogram (U/kg) body weight of IncobotulinumtoxinA (Xeomin) with a maximum of 400 to 500 units per injection treatment via intramuscular injection into spastic muscles on Day 1 of 4 treatment cycles (12 to 16 weeks treatment per each cycle). The higher dose could only be administered to participants with GMFCS-E&R levels I to III.
116629|NCT01905553|B3|Baseline|Total|Total of all reporting groups
116689|NCT01904864|P2|Participant Flow|Ferrous Sulfate|Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation, ferrous sulfate, for 12 weeks.
116596|NCT01905683|O1|Outcome|16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received total doses of 16 to 20 unit per kilogram (U/kg) body weight of IncobotulinumtoxinA (Xeomin) with a maximum of 400 to 500 units per injection treatment via intramuscular injection into spastic muscles on Day 1 of 4 treatment cycles (12 to 16 weeks treatment per each cycle). The higher dose could only be administered to participants with GMFCS-E&R levels I to III.
116597|NCT01905683|O1|Outcome|16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received total doses of 16 to 20 unit per kilogram (U/kg) body weight of IncobotulinumtoxinA (Xeomin) with a maximum of 400 to 500 units per injection treatment via intramuscular injection into spastic muscles on Day 1 of 4 treatment cycles (12 to 16 weeks treatment per each cycle). The higher dose could only be administered to participants with GMFCS-E&R levels I to III.
116598|NCT01905683|O1|Outcome|16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received total doses of 16 to 20 unit per kilogram (U/kg) body weight of IncobotulinumtoxinA (Xeomin) with a maximum of 400 to 500 units per injection treatment via intramuscular injection into spastic muscles on Day 1 of 4 treatment cycles (12 to 16 weeks treatment per each cycle). The higher dose could only be administered to participants with GMFCS-E&R levels I to III.
116599|NCT01905683|O1|Outcome|16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received total doses of 16 to 20 unit per kilogram (U/kg) body weight of IncobotulinumtoxinA (Xeomin) with a maximum of 400 to 500 units per injection treatment via intramuscular injection into spastic muscles on Day 1 of 4 treatment cycles (12 to 16 weeks treatment per each cycle). The higher dose could only be administered to participants with GMFCS-E&R levels I to III.
116600|NCT01905683|E1|Reported Event|16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received total doses of 16 to 20 unit per kilogram (U/kg) body weight of IncobotulinumtoxinA (Xeomin) with a maximum of 400 to 500 units per injection treatment via intramuscular injection into spastic muscles on Day 1 of 4 treatment cycles (12 to 16 weeks treatment per each cycle). The higher dose could only be administered to participants with GMFCS-E&R levels I to III.
116601|NCT01905657|B4|Baseline|Total|Total of all reporting groups
116602|NCT01905657|B3|Baseline|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
116603|NCT01905657|B2|Baseline|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
116604|NCT01905657|B1|Baseline|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
116605|NCT01905657|P3|Participant Flow|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
116606|NCT01905657|P2|Participant Flow|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
116607|NCT01905657|P1|Participant Flow|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 2 years.
116608|NCT01905657|O3|Outcome|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
116609|NCT01905657|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
116610|NCT01905657|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
116611|NCT01905657|O3|Outcome|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
116612|NCT01905657|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
116613|NCT01905657|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
116614|NCT01905657|O3|Outcome|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
116615|NCT01905657|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
116616|NCT01905657|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
116617|NCT01905657|O3|Outcome|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
116618|NCT01905657|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
116619|NCT01905657|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
116620|NCT01905657|O3|Outcome|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
116621|NCT01905657|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
116622|NCT01905657|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
116623|NCT01905657|O3|Outcome|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
116624|NCT01905657|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
116625|NCT01905657|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
116626|NCT01905657|E3|Reported Event|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
116627|NCT01905657|E2|Reported Event|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
116630|NCT01905553|B2|Baseline|SSP-004184SS Fasted First|Subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions on Day 1 in Treatment Period 1. During Treatment Period 2, subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast.
116631|NCT01905553|B1|Baseline|SSP-004184SS Fed First|Subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast in Treatment Period 1. During Treatment Period 2, subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions.
116632|NCT01905553|P2|Participant Flow|SSP-004184SS Fasted First|Subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions on Day 1 in Treatment Period 1. During Treatment Period 2, subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast.
116633|NCT01905553|P1|Participant Flow|SSP-004184SS Fed First|Subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast in Treatment Period 1. During Treatment Period 2, subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions.
116634|NCT01905553|O2|Outcome|SSP-004184SS (Fasted)|21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions.
116635|NCT01905553|O1|Outcome|SSP-004184SS (Fed)|21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions.
116636|NCT01905553|O2|Outcome|SSP-004184SS (Fasted)|21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions.
116637|NCT01905553|O1|Outcome|SSP-004184SS (Fed)|21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions.
116638|NCT01905553|O2|Outcome|SSP-004184SS (Fasted)|21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions.
116639|NCT01905553|O1|Outcome|SSP-004184SS (Fed)|21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions.
116640|NCT01905553|E2|Reported Event|SSP-004184SS (Fasted)|21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions.
116641|NCT01905553|E1|Reported Event|SSP-004184SS (Fed)|21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions.
116642|NCT01905540|B5|Baseline|Total|Total of all reporting groups
116643|NCT01905540|B4|Baseline|SS-AQ-SS2|SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.
116644|NCT01905540|B3|Baseline|SS-AQ-AQ2|SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.
116645|NCT01905540|B2|Baseline|AQ-SS-SS2|SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.
116646|NCT01905540|B1|Baseline|AQ-SS-AQ2|SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.
116647|NCT01905540|P4|Participant Flow|SS-AQ-SS2|SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.
116648|NCT01905540|P3|Participant Flow|SS-AQ-AQ2|SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.
116649|NCT01905540|P2|Participant Flow|AQ-SS-SS2|SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.
116650|NCT01905540|P1|Participant Flow|AQ-SS-AQ2|SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.
116651|NCT01905540|O2|Outcome|SSP-004184SS (2 Doses)|SSP-004184SS 21.8mg/kg morning and evening dose
116652|NCT01905540|O1|Outcome|SSP-004184AQ (2 Doses)|SSP-004184AQ 40mg/kg morning and evening dose.
116653|NCT01905540|O2|Outcome|SSP-004184SS (2 Doses)|SSP-004184SS 21.8mg/kg morning and evening dose
116654|NCT01905540|O1|Outcome|SSP-004184AQ (2 Doses)|SSP-004184AQ 40mg/kg morning and evening dose.
116655|NCT01905540|O2|Outcome|SSP-004184SS (2 Doses)|SSP-004184SS 21.8mg/kg morning and evening dose
116656|NCT01905540|O1|Outcome|SSP-004184AQ (2 Doses)|SSP-004184AQ 40mg/kg morning and evening dose.
116657|NCT01905540|O2|Outcome|SSP-004184SS (Single Dose)|21.8 mg/kg (oral capsule form) given once on Day 1
116658|NCT01905540|O1|Outcome|SSP-004184AQ (Single Dose)|40 mg/kg (oral capsule form) given once on Day 1
116659|NCT01905540|O2|Outcome|SSP-004184SS (Single Dose)|21.8 mg/kg (oral capsule form) given once on Day 1
116660|NCT01905540|O1|Outcome|SSP-004184AQ (Single Dose)|40 mg/kg (oral capsule form) given once on Day 1
116661|NCT01905540|O2|Outcome|SSP-004184SS (Single Dose)|21.8 mg/kg (oral capsule form) given once on Day 1
116662|NCT01905540|O1|Outcome|SSP-004184AQ (Single Dose)|40 mg/kg (oral capsule form) given once on Day 1
116663|NCT01905540|E4|Reported Event|SSP-004184SS (2 Doses)|SSP-004184SS: 21.8mg/kg (equivalent to 18.1mg/kg free-acid dose) administered in the morning and 21.8mg/kg administered 12 hours later.
116664|NCT01905540|E3|Reported Event|SSP-004184AQ (2 Doses)|SP-004184AQ: 40mg/kg (equivalent to 36.2mg/kg free-acid dose) administered in the morning and 40mg/kg administered 12 hours later.
116665|NCT01905540|E2|Reported Event|SSP-004184SS (Single Dose)|SSP-004184SS: 21.8mg/kg (equivalent to 18.1mg/kg free-acid dose) administered as a single dose in a fasted state in the morning.
116666|NCT01905540|E1|Reported Event|SSP-004184AQ (Single Dose)|SSP-004184AQ: 40mg/kg (equivalent to 36.2mg/kg free-acid dose) administered as a single dose in a fasted state in the morning.
116667|NCT01905423|B5|Baseline|Total|Total of all reporting groups
116668|NCT01905423|B4|Baseline|Semiannual MDA Treated Group (Pekalongan)|"The Pekalongan study site was dropped from further analysis after the first year follow-up due to lower than expected prevalence of lymphatic filariasis infections. Baseline and year 1 follow-up results are presented separately from the other study sites.~This group will receive semiannual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health.~Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly"
120384|NCT01884545|O1|Outcome|Health Coaching|Participants who received health coaching
116669|NCT01905423|B3|Baseline|Annual MDA Treated Group (Pekalongan)|"The Pekalongan study site was dropped from further analysis after the first year follow-up due to lower than expected prevalence of lymphatic filariasis infections. Baseline and year 1 follow-up results are presented separately from the other study sites.~This group will receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.~Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly"
116670|NCT01905423|B2|Baseline|Semiannual MDA Treated Group|"This group will receive semiannual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health.~Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly"
116671|NCT01905423|B1|Baseline|Annual MDA Treated Group|"This group will receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.~Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly"
116672|NCT01905423|P4|Participant Flow|Semiannual MDA Treated Group (Pekalongan)|"The Pekalongan study site was dropped from further analysis after teh first year follow-up due to lower than expected prevalence of lymphatic filariasis infections. Baseline and year 1 follow-up results are presented separately from the other study sites. This group will receive semiannual MDA (Albaendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesia Ministry of Health as part of their national filariasis elimination program.~Albendazole and diethylcarbamazine: Ablendazole 400 mg plus diethylcarbamzine 6 mg/kg once yearly vs twice yearly"
116673|NCT01905423|P3|Participant Flow|Annual MDA Treated Group (Pekalongan)|"The Pekalongan study site was dropped from further analysis after teh first year follow-up due to lower than expected prevalence of lymphatic filariasis infections. Baseline and year 1 follow-up results are presented separately from the other study sites. This group will receive annual MDA (Albaendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesia Ministry of Health as part of their national filariasis elimination program.~Albendazole and diethylcarbamazine: Ablendazole 400 mg plus diethylcarbamzine 6 mg/kg once yearly vs twice yearly"
116674|NCT01905423|P2|Participant Flow|Semiannual MDA Treated Group|"This group will receive semiannual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health.~Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly"
116675|NCT01905423|P1|Participant Flow|Annual MDA Treated Group|"This group will receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.~Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly"
116676|NCT01905423|O2|Outcome|Semiannual MDA Treated Group|"This group will receive semiannual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health.~Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly"
116677|NCT01905423|O1|Outcome|Annual MDA Treated Group|"This group will receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.~Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly"
116678|NCT01905423|O2|Outcome|Semiannual MDA Treated Group|"This group will receive semiannual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health.~Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly"
116679|NCT01905423|O1|Outcome|Annual MDA Treated Group|"This group will receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.~Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly"
116680|NCT01905423|E2|Reported Event|Semiannual MDA Treated Group|"This group will receive semiannual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health.~Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly"
116681|NCT01905423|E1|Reported Event|Annual MDA Treated Group|"This group will receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.~Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly"
116682|NCT01905254|B1|Baseline|Single Arm Study|Alle patients received a liver biopsy and Transient elastopgrapy for follow-up of Autoimmune Hepatitis or staging and grading of Autoimmune hepatitis.
116683|NCT01905254|P1|Participant Flow|Transient Elastography and Liver Biopsy|"Transient elastography was performed by two experienced investigators using a FibroScan (EchoSens, Paris, France), the median value of liver stiffness measurements was recorded in kilopascals (kPa).~Liver biopsy was carried out within 3 months of TE. Liver biopsies from the right and left lobe were obtained under laparoscopic control using the Tru-cut 16 GAUGE needle (Bard monopty; Bard biopsy systems, Tempe, USA).~Data analysis was performed on the remaining 34 patients (female: 28 (82%); male: 6 (18 %).~Indications for liver biopsy and Transient elastography were: 19 patients for follow-up of AIH while receiving immunosuppression and 15 patients for staging and grading of AIH before starting with an immunosuppressive therapy in."
116684|NCT01905254|O1|Outcome|Transient Elastography in Autoimmune Hepatitis|Liver stiffness (kPa) was correlated to histologic staging of liver cirrhosis
116685|NCT01905254|E1|Reported Event|TE in Autoimmune Hepatitis|"Alle patients received a liver biopsy and Transient elastopgrapy for follow-up of Autoimmune Hepatitis or staging and grading of Autoimmune hepatitis.~There were no adverse events."
116686|NCT01904864|B3|Baseline|Total|Total of all reporting groups
116687|NCT01904864|B2|Baseline|Ferrous Sulfate|Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation, ferrous sulfate, for 12 weeks.
116688|NCT01904864|B1|Baseline|NovaFerrum® (Iron Polysaccharide Complex)|Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation of an iron polysaccharide complex (NovaFerrum®), for 12 weeks.
116690|NCT01904864|P1|Participant Flow|NovaFerrum® (Iron Polysaccharide Complex)|Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation of an iron polysaccharide complex (NovaFerrum®), for 12 weeks.
116691|NCT01904864|O2|Outcome|Ferrous Sulfate|Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation, ferrous sulfate, for 12 weeks.
116692|NCT01904864|O1|Outcome|NovaFerrum® (Iron Polysaccharide Complex)|Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation of an iron polysaccharide complex (NovaFerrum®), for 12 weeks.
116693|NCT01904864|E2|Reported Event|Ferrous Sulfate|Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation, ferrous sulfate, for 12 weeks.
116694|NCT01904864|E1|Reported Event|NovaFerrum® (Iron Polysaccharide Complex)|Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation of an iron polysaccharide complex (NovaFerrum®), for 12 weeks.
116695|NCT01904773|B1|Baseline|Overall Study|Part 1 & Part 2
116696|NCT01904773|P9|Participant Flow|Part 2- Seqence CBABCA|A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
116697|NCT01904773|P8|Participant Flow|Part 2 Sequence CABBAC|A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
116698|NCT01904773|P7|Participant Flow|Part 2- Sequence BCACBA|A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
116699|NCT01904773|P6|Participant Flow|Part 2- Sequence BACCAB|A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
116700|NCT01904773|P5|Participant Flow|Part 2- Sequence ACBABC|A= Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
116701|NCT01904773|P4|Participant Flow|Part 2 - Sequence ABCACB|A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
116702|NCT01904773|P3|Participant Flow|Part 2- Sequence BABBAB|B=AZD5213 0.5 mg, A=Placebo (did not tolerate 2.0 mg in Part 1)
116703|NCT01904773|P2|Participant Flow|Part 2 -Sequence BBABBA|B=AZD5213 0.5 mg, A=Placebo (did not tolerate 2.0 mg in Part 1)
116704|NCT01904773|P1|Participant Flow|Initial Study|Initial Screen, Part 1: AZD5213 0.5 mg single dose Day 1, AZD5213 2 mg dose Days 6-8
116705|NCT01904773|O1|Outcome|AZD5213 0.5 mg|Part 1 single dose, Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
116706|NCT01904773|O1|Outcome|AZD5213 0.5 mg|Part 1 single dose, Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
116707|NCT01904773|O1|Outcome|AZD5213 0.5 mg|Part 1 single dose, Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
116708|NCT01904773|O3|Outcome|Placebo|Part 2 - multiple 3 week treatment periods in a randomized 6- period crossover design
116709|NCT01904773|O2|Outcome|AZD5213 2.0 mg|Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
116710|NCT01904773|O1|Outcome|AZD5213 0.5 mg|Part 1 single dose, Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
116711|NCT01904773|E7|Reported Event|Part 1 - Placebo|Part 1 - Placebo, Days 2-5, washout after 0.5 mg single dose
116712|NCT01904773|E6|Reported Event|Part 2 - Placebo|Part 2 - Placebo periods (2 periods)
116713|NCT01904773|E5|Reported Event|Part 2 - AZD5213 2.0 mg|Part 2 - AZD5213, 2.0 mg periods (2 periods)
116714|NCT01904773|E4|Reported Event|Part 2 - AZD5213 0.5 mg|Part 2 - AZD5213, 0.5 mg periods (2-4 periods)
116715|NCT01904773|E3|Reported Event|Part 1 - AZD5213 2.0 mg|Part 1 - Days 6-8, AZD5213 2.0 mg
116716|NCT01904773|E2|Reported Event|Part 1 - AZD5213 0.5 mg|Part 1 - Day 1, AZD5213 0.5 mg
116717|NCT01904773|E1|Reported Event|Overall Study|Part 1 & Part 2
116718|NCT01904760|B3|Baseline|Total|Total of all reporting groups
116719|NCT01904760|B2|Baseline|Control|"Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Saline placebo: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day"
116720|NCT01904760|B1|Baseline|Dexmedetomidine|"Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Dexmedetomidine: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day."
116721|NCT01904760|P2|Participant Flow|Control|"Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Saline placebo: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day"
116722|NCT01904760|P1|Participant Flow|Dexmedetomidine|"Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Dexmedetomidine: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day."
116723|NCT01904760|O2|Outcome|Control|"Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Saline placebo: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day"
116724|NCT01904760|O1|Outcome|Dexmedetomidine|"Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Dexmedetomidine: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day."
116725|NCT01904760|O2|Outcome|Control|"Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Saline placebo: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day"
116726|NCT01904760|O1|Outcome|Dexmedetomidine|"Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Dexmedetomidine: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day."
116727|NCT01904760|E2|Reported Event|Control|"Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Saline placebo: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day"
116728|NCT01904760|E1|Reported Event|Dexmedetomidine|"Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Dexmedetomidine: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day."
116729|NCT01904721|B8|Baseline|Total|Total of all reporting groups
116730|NCT01904721|B7|Baseline|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116731|NCT01904721|B6|Baseline|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116732|NCT01904721|B5|Baseline|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116733|NCT01904721|B4|Baseline|Stage 1: Bimatoprost Solution 2 Once Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
116734|NCT01904721|B3|Baseline|Stage 1: Bimatoprost Solution 2 Twice Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
116735|NCT01904721|B2|Baseline|Stage 1: Bimatoprost Solution 1 Once Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
116736|NCT01904721|B1|Baseline|Stage 1: Bimatoprost Solution 1 Twice Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
116737|NCT01904721|P7|Participant Flow|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116738|NCT01904721|P6|Participant Flow|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116739|NCT01904721|P5|Participant Flow|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116740|NCT01904721|P4|Participant Flow|Stage 1: Bimatoprost Solution 2 Once Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
116741|NCT01904721|P3|Participant Flow|Stage 1: Bimatoprost Solution 2 Twice Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
116742|NCT01904721|P2|Participant Flow|Stage 1: Bimatoprost Solution 1 Once Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
116743|NCT01904721|P1|Participant Flow|Stage 1: Bimatoprost Solution 1 Twice Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
116744|NCT01904721|O3|Outcome|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116745|NCT01904721|O2|Outcome|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116746|NCT01904721|O1|Outcome|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116747|NCT01904721|O3|Outcome|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116748|NCT01904721|O2|Outcome|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116749|NCT01904721|O1|Outcome|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116750|NCT01904721|O3|Outcome|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116751|NCT01904721|O2|Outcome|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116752|NCT01904721|O1|Outcome|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116753|NCT01904721|O3|Outcome|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116754|NCT01904721|O2|Outcome|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116755|NCT01904721|O1|Outcome|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116756|NCT01904721|O3|Outcome|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116757|NCT01904721|O2|Outcome|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116758|NCT01904721|O1|Outcome|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116759|NCT01904721|O3|Outcome|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116760|NCT01904721|O2|Outcome|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116761|NCT01904721|O1|Outcome|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116762|NCT01904721|E7|Reported Event|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116763|NCT01904721|E6|Reported Event|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116764|NCT01904721|E5|Reported Event|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
116765|NCT01904721|E4|Reported Event|Stage 1: Bimatoprost Solution 2 Once Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
116766|NCT01904721|E3|Reported Event|Stage 1: Bimatoprost Solution 2 Twice Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
116767|NCT01904721|E2|Reported Event|Stage 1: Bimatoprost Solution 1 Once Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
116768|NCT01904721|E1|Reported Event|Stage 1: Bimatoprost Solution 1 Twice Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
116769|NCT01904604|B4|Baseline|Total|Total of all reporting groups
116770|NCT01904604|B3|Baseline|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
116771|NCT01904604|B2|Baseline|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
116772|NCT01904604|B1|Baseline|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
116773|NCT01904604|P3|Participant Flow|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
116774|NCT01904604|P2|Participant Flow|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
116775|NCT01904604|P1|Participant Flow|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
116776|NCT01904604|O3|Outcome|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
116808|NCT01904279|P1|Participant Flow|TCZ SC 162 mg Q3W|Participants with body weight less than (<) 30 kilograms (kg) were administered 162 milligrams (mg) of TCZ as an subcutaneous (SC) injection every 3 weeks (Q3W) for 52 weeks.
116809|NCT01904279|O2|Outcome|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
116810|NCT01904279|O1|Outcome|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
116777|NCT01904604|O2|Outcome|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
116778|NCT01904604|O1|Outcome|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
116779|NCT01904604|O3|Outcome|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
116780|NCT01904604|O2|Outcome|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
116781|NCT01904604|O1|Outcome|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
116782|NCT01904604|O2|Outcome|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
116783|NCT01904604|O1|Outcome|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
116784|NCT01904604|O3|Outcome|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
116811|NCT01904279|O2|Outcome|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 Weeks.
116812|NCT01904279|O1|Outcome|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
116813|NCT01904279|O2|Outcome|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
116814|NCT01904279|O1|Outcome|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
116815|NCT01904279|O2|Outcome|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
116785|NCT01904604|O2|Outcome|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
116786|NCT01904604|O1|Outcome|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
116787|NCT01904604|E3|Reported Event|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
116788|NCT01904604|E2|Reported Event|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
116789|NCT01904604|E1|Reported Event|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
116790|NCT01904526|B1|Baseline|Guanfacine|Guanfacine: 3mg/day IR with 3-week lead-in period. Maintained at steady state to complete lab session. After completion of lab session, 1-week lead-in medication period to 4mg/day ER. Maintained at steady state to complete lab session. After completion of lab session, 1-week lead-in medication period to 6mg/day ER. Maintained at steady state to complete lab session. 5-day taper after lab.
116791|NCT01904526|P1|Participant Flow|Guanfacine|Guanfacine: 3mg/day immediate release (IR) with 3-week lead-in period. Maintained at steady state to complete lab session. After completion of lab session, 1-week lead-in medication period to 4mg/day extended release (ER). Maintained at steady state to complete lab session. After completion of lab session, 1-week lead-in medication period to 6mg/day ER. Maintained at steady state to complete lab session. 5-day taper after lab.
116792|NCT01904526|O3|Outcome|Guanfacine 6mg/Day Extended Release|Guanfacine: 6mg/day extended release
116793|NCT01904526|O2|Outcome|Guanfacine 4mg/Day Extended Release|Guanfacine: 4mg/day extended release
116794|NCT01904526|O1|Outcome|Guanfacine 3mg/Day Immediate Release|Guanfacine: 3mg/day immediate release
116795|NCT01904526|O3|Outcome|Guanfacine 6mg/Day Extended Release|Guanfacine: 6mg/day extended release
116796|NCT01904526|O2|Outcome|Guanfacine 4mg/Day Extended Release|Guanfacine: 4mg/day extended release
116797|NCT01904526|O1|Outcome|Guanfacine 3mg/Day Immediate Release|Guanfacine: 3mg/day immediate release
116798|NCT01904526|O3|Outcome|Guanfacine 6mg/Day Extended Release|Guanfacine: 6mg/day extended release
116799|NCT01904526|O2|Outcome|Guanfacine 4mg/Day Extended Release|Guanfacine: 4mg/day extended release
116800|NCT01904526|O1|Outcome|Guanfacine 3mg/Day Immediate Release|Guanfacine: 3mg/day immediate release
116801|NCT01904526|E3|Reported Event|Guanfacine 6mg/Day Extended Release|Guanfacine: 6mg/day extended release
116802|NCT01904526|E2|Reported Event|Guanfacine 4mg/Day Extended Release|Guanfacine: 4mg/day extended release
116803|NCT01904526|E1|Reported Event|Guanfacine 3mg/Day Immediate Release|Guanfacine: 3mg/day immediate release
116804|NCT01904279|B3|Baseline|Total|Total of all reporting groups
116805|NCT01904279|B2|Baseline|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
116806|NCT01904279|B1|Baseline|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
116807|NCT01904279|P2|Participant Flow|TCZ SC 162 mg Q2W|Participants with body weight greater than or equal to (>/=) 30 kg were administered 162 mg of TCZ as an SC injection every 2 weeks (Q2W) for 52 weeks.
116816|NCT01904279|O1|Outcome|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
116817|NCT01904279|O2|Outcome|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
116818|NCT01904279|O1|Outcome|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
116819|NCT01904279|O2|Outcome|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
116820|NCT01904279|O1|Outcome|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
116821|NCT01904279|O2|Outcome|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
116822|NCT01904279|O1|Outcome|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
116823|NCT01904279|O2|Outcome|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
116824|NCT01904279|O1|Outcome|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
116825|NCT01904279|E2|Reported Event|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
116826|NCT01904279|E1|Reported Event|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
116827|NCT01904149|B7|Baseline|Total|Total of all reporting groups
116828|NCT01904149|B6|Baseline|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses
116829|NCT01904149|B5|Baseline|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses
116830|NCT01904149|B4|Baseline|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
116831|NCT01904149|B3|Baseline|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses
116832|NCT01904149|B2|Baseline|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
116833|NCT01904149|B1|Baseline|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
116834|NCT01904149|P6|Participant Flow|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses
116835|NCT01904149|P5|Participant Flow|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses
116836|NCT01904149|P4|Participant Flow|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
116837|NCT01904149|P3|Participant Flow|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses
116838|NCT01904149|P2|Participant Flow|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
116839|NCT01904149|P1|Participant Flow|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
116840|NCT01904149|O3|Outcome|TRAMADOL|Drug: Tramadol multiple doses; Arm type: active comparator; Tramadol multiple oral doses t.i.d. for 3 days (a total of 6 doses)
116841|NCT01904149|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen multiple doses; Arm type: active comparator; Dexketoprofen multiple oral doses t.i.d. for 3 days (a total of 6 doses)
116842|NCT01904149|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol multiple doses; Arm type: experimental; Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (a total of 6 doses)
116843|NCT01904149|O3|Outcome|TRAMADOL|Drug: Tramadol multiple doses; Arm type: active comparator; Tramadol multiple oral doses t.i.d. for 3 days (a total of 6 doses)
116844|NCT01904149|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen multiple doses; Arm type: active comparator; Dexketoprofen multiple oral doses t.i.d. for 3 days (a total of 6 doses)
116845|NCT01904149|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol multiple doses; Arm type: experimental; Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (a total of 6 doses)
116846|NCT01904149|O4|Outcome|PLACEBO|Drug: Placebo; Arm type: PLACEBO comparator; Placebo single oral dose during single dose phase (first 8 hours); Drug: Placebo single oral dose (first 8 hours) Arm type: placebo comparator; placebo single oral dose (first 8 hours)
116847|NCT01904149|O3|Outcome|TRAMADOL|Drug: Tramadol single oral dose (first 8 hours) Arm type: active comparator; Tramadol single oral dose (first 8 hours)
116848|NCT01904149|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen single oral dose (first 8 hours) Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours)
116849|NCT01904149|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours) Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours)
116850|NCT01904149|O4|Outcome|PLACEBO|Drug: Placebo single oral dose (first 8 hours) Arm type: Placebo comparator; Placebo single oral dose (first 8 hours)
116851|NCT01904149|O3|Outcome|TRAMADOL|Drug: Tramadol single oral dose (first 8 hours) Arm type: active comparator; Tramadol single oral dose (first 8 hours)
116852|NCT01904149|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen single oral dose (first 8 hours) Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours)
116853|NCT01904149|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours) Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours)
116854|NCT01904149|E6|Reported Event|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses
116855|NCT01904149|E5|Reported Event|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses
116856|NCT01904149|E4|Reported Event|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
116857|NCT01904149|E3|Reported Event|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses
116858|NCT01904149|E2|Reported Event|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
116859|NCT01904149|E1|Reported Event|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
116860|NCT01904071|B4|Baseline|Total|Total of all reporting groups
116881|NCT01904071|O1|Outcome|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
116861|NCT01904071|B3|Baseline|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
116862|NCT01904071|B2|Baseline|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
116863|NCT01904071|B1|Baseline|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
116864|NCT01904071|P3|Participant Flow|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
116865|NCT01904071|P2|Participant Flow|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
116866|NCT01904071|P1|Participant Flow|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
116867|NCT01904071|O3|Outcome|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
116868|NCT01904071|O2|Outcome|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
116869|NCT01904071|O1|Outcome|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
116870|NCT01904071|O3|Outcome|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
116871|NCT01904071|O2|Outcome|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
116872|NCT01904071|O1|Outcome|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
116873|NCT01904071|O3|Outcome|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
116874|NCT01904071|O2|Outcome|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
116875|NCT01904071|O1|Outcome|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
116876|NCT01904071|O3|Outcome|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
116877|NCT01904071|O2|Outcome|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
116878|NCT01904071|O1|Outcome|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
116879|NCT01904071|O3|Outcome|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
116880|NCT01904071|O2|Outcome|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
116882|NCT01904071|E3|Reported Event|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
116883|NCT01904071|E2|Reported Event|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
116884|NCT01904071|E1|Reported Event|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
116885|NCT01904058|B5|Baseline|Total|Total of all reporting groups
116886|NCT01904058|B4|Baseline|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116887|NCT01904058|B3|Baseline|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116888|NCT01904058|B2|Baseline|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116889|NCT01904058|B1|Baseline|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116890|NCT01904058|P4|Participant Flow|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116891|NCT01904058|P3|Participant Flow|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116892|NCT01904058|P2|Participant Flow|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116893|NCT01904058|P1|Participant Flow|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116894|NCT01904058|O4|Outcome|Placebo + UDCA|Participants received placebo matched to LUM001 tablet orally once daily for a period of 13 weeks in combination with UDCA.
116895|NCT01904058|O3|Outcome|LUM001 20 mg + UDCA|Participants received LUM001 20 mg (2x 10 mg) tablet for 20 mg daily dose in combination with UDCA orally once daily for a period of 13 weeks.
116896|NCT01904058|O2|Outcome|LUM001 10 mg + UDCA|Participants received LUM001 10 mg tablet orally once daily for a period of 13 weeks in combination with UDCA.
116897|NCT01904058|O1|Outcome|LUM001 5 mg + UDCA|Participants received LUM001 5 milligram (mg) tablet orally once daily for a period of 13 weeks in combination with UDCA.
116898|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116899|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116900|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116901|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116902|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116903|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116904|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
120412|NCT01884545|O1|Outcome|Health Coaching|Participants who received health coaching
116905|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116906|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116907|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116908|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116909|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116910|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116911|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116912|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116913|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116914|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116915|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116916|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116917|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116918|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116919|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116920|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116921|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116922|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116923|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116924|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
136503|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
116925|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
116926|NCT01904058|E4|Reported Event|Placebo + UDCA|Participants received placebo matched to LUM001 tablet orally once daily for a period of 13 weeks in combination with UDCA.
116927|NCT01904058|E3|Reported Event|LUM001 20 mg + UDCA|Participants received LUM001 20 mg (2x 10 mg) tablet for 20 mg daily dose in combination with UDCA orally once daily for a period of 13 weeks.
116928|NCT01904058|E2|Reported Event|LUM001 10 mg + UDCA|Participants received LUM001 10 mg tablet orally once daily for a period of 13 weeks in combination with UDCA.
116929|NCT01904058|E1|Reported Event|LUM001 5 mg + UDCA|Participants received LUM001 5 mg tablet orally once daily for a period of 13 weeks in combination with UDCA.
116930|NCT01903993|B3|Baseline|Total|Total of all reporting groups
116931|NCT01903993|B2|Baseline|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
116932|NCT01903993|B1|Baseline|Docetaxel|Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
116933|NCT01903993|P2|Participant Flow|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
116934|NCT01903993|P1|Participant Flow|Docetaxel|Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
116935|NCT01903993|O1|Outcome|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
116936|NCT01903993|O1|Outcome|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
116937|NCT01903993|O1|Outcome|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
116938|NCT01903993|O2|Outcome|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
116939|NCT01903993|O1|Outcome|Docetaxel|Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
116940|NCT01903993|O2|Outcome|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
116941|NCT01903993|O1|Outcome|Docetaxel|Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
116942|NCT01903993|O2|Outcome|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
116943|NCT01903993|O1|Outcome|Docetaxel|Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
116944|NCT01903993|O2|Outcome|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
116945|NCT01903993|O1|Outcome|Docetaxel|Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
116946|NCT01903993|E2|Reported Event|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
116947|NCT01903993|E1|Reported Event|Docetaxel|Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
116948|NCT01903876|B3|Baseline|Total|Total of all reporting groups
116949|NCT01903876|B2|Baseline|Bystander & Sexual Violence Prevention|"A 3-hour web-based program designed to teach male college student bystanders to intervene.~Bystander & Sexual Violence Prevention: This 3-hour web-based program consists of six 30-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama, which allows for the modeling of positive behaviors and illustrate both positive and negative outcome expectations for intervening and for perpetrating abuse against women. Behaviors modeled include communicating with female sex partners, obtaining informed consent to have sex, and intervening to prevent abuse from taking place."
116950|NCT01903876|B1|Baseline|General Health Promotion|"A 3-hour general mental health web-based program.~General Health Promotion: This general health promotion web-based program is 3-hours and provides a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise."
116951|NCT01903876|P2|Participant Flow|Bystander & Sexual Violence Prevention|A 3-hour web-based program designed to teach male college student bystanders to intervene.
116953|NCT01903876|O2|Outcome|Bystander & Sexual Violence Prevention|"A 3-hour web-based program designed to teach male college student bystanders to intervene.~Bystander & Sexual Violence Prevention: This 3-hour web-based program consists of six 30-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama, which allows for the modeling of positive behaviors and illustrate both positive and negative outcome expectations for intervening and for perpetrating abuse against women. Behaviors modeled include communicating with female sex partners, obtaining informed consent to have sex, and intervening to prevent abuse from taking place."
116954|NCT01903876|O1|Outcome|General Health Promotion|"A 3-hour general mental health web-based program.~General Health Promotion: This general health promotion web-based program is 3-hours and provides a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise."
116955|NCT01903876|O2|Outcome|Bystander & Sexual Violence Prevention|"A 3-hour web-based program designed to teach male college student bystanders to intervene.~Bystander & Sexual Violence Prevention: This 3-hour web-based program consists of six 30-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama, which allows for the modeling of positive behaviors and illustrate both positive and negative outcome expectations for intervening and for perpetrating abuse against women. Behaviors modeled include communicating with female sex partners, obtaining informed consent to have sex, and intervening to prevent abuse from taking place."
116956|NCT01903876|O1|Outcome|General Health Promotion|"A 3-hour general mental health web-based program.~General Health Promotion: This general health promotion web-based program is 3-hours and provides a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise."
116957|NCT01903876|E2|Reported Event|Bystander & Sexual Violence Prevention|"A 3-hour web-based program designed to teach male college student bystanders to intervene.~Bystander & Sexual Violence Prevention: This 3-hour web-based program consists of six 30-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama, which allows for the modeling of positive behaviors and illustrate both positive and negative outcome expectations for intervening and for perpetrating abuse against women. Behaviors modeled include communicating with female sex partners, obtaining informed consent to have sex, and intervening to prevent abuse from taking place."
116958|NCT01903876|E1|Reported Event|General Health Promotion|"A 3-hour general mental health web-based program.~General Health Promotion: This general health promotion web-based program is 3-hours and provides a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise."
116959|NCT01903863|B3|Baseline|Total|Total of all reporting groups
116960|NCT01903863|B2|Baseline|Control|"Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
116961|NCT01903863|B1|Baseline|Scheduled Fresh Frozen Plasma|"Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
116962|NCT01903863|P2|Participant Flow|Control|"Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
116963|NCT01903863|P1|Participant Flow|Scheduled Fresh Frozen Plasma|"Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement."
116964|NCT01903863|O2|Outcome|Control|"Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
116965|NCT01903863|O1|Outcome|Scheduled Fresh Frozen Plasma|"Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement."
117001|NCT01903564|P1|Participant Flow|Normal|"pregnant women with uncomplicated pregnancies~magnetocardiography: recording of magnetic heart activity~fetal echocardiography: fetal echocardiography"
116966|NCT01903863|O2|Outcome|Control|"Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
116967|NCT01903863|O1|Outcome|Scheduled Fresh Frozen Plasma|"Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement."
116968|NCT01903863|O2|Outcome|Control|"Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
116969|NCT01903863|O1|Outcome|Scheduled Fresh Frozen Plasma|"Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement."
116970|NCT01903863|O2|Outcome|Control|"Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
116971|NCT01903863|O1|Outcome|Scheduled Fresh Frozen Plasma|"Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement."
116972|NCT01903863|O2|Outcome|Control|"Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
116973|NCT01903863|O1|Outcome|Scheduled Fresh Frozen Plasma|"Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement."
116974|NCT01903863|O2|Outcome|Control|"Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
116975|NCT01903863|O1|Outcome|Scheduled Fresh Frozen Plasma|"Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement."
116976|NCT01903863|O2|Outcome|Control|"Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
117002|NCT01903564|O2|Outcome|High-risk|"pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia~magnetocardiography: recording of magnetic heart activity~postnatal ECG: postnatal ECG~fetal echocardiography: fetal echocardiography"
116977|NCT01903863|O1|Outcome|Scheduled Fresh Frozen Plasma|"Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement."
116978|NCT01903863|O2|Outcome|Control|"Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
116979|NCT01903863|O1|Outcome|Scheduled Fresh Frozen Plasma|"Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement."
116980|NCT01903863|E2|Reported Event|Control|"Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
116981|NCT01903863|E1|Reported Event|Scheduled Fresh Frozen Plasma|"Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.~Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement."
116982|NCT01903720|B1|Baseline|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
116983|NCT01903720|P1|Participant Flow|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
116984|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
116985|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
116986|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
116987|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
116988|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
116989|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
116990|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
116991|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
116992|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
116993|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
116994|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
116995|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
116996|NCT01903720|E1|Reported Event|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
116997|NCT01903564|B3|Baseline|Total|Total of all reporting groups
116998|NCT01903564|B2|Baseline|High-risk|"pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia~magnetocardiography: recording of magnetic heart activity~postnatal ECG: postnatal ECG~fetal echocardiography: fetal echocardiography"
116999|NCT01903564|B1|Baseline|Normal|"pregnant women with uncomplicated pregnancies~magnetocardiography: recording of magnetic heart activity~fetal echocardiography: fetal echocardiography"
117000|NCT01903564|P2|Participant Flow|High-risk|"pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia~magnetocardiography: recording of magnetic heart activity~postnatal ECG: postnatal ECG~fetal echocardiography: fetal echocardiography"
117003|NCT01903564|O1|Outcome|Normal|"pregnant women with uncomplicated pregnancies~magnetocardiography: recording of magnetic heart activity~fetal echocardiography: fetal echocardiography"
117004|NCT01903564|O2|Outcome|High-risk|"pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia~magnetocardiography: recording of magnetic heart activity~postnatal ECG: postnatal ECG~fetal echocardiography: fetal echocardiography"
117005|NCT01903564|O1|Outcome|Normal|"pregnant women with uncomplicated pregnancies~magnetocardiography: recording of magnetic heart activity~fetal echocardiography: fetal echocardiography"
117006|NCT01903564|O2|Outcome|High-risk|"pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia~magnetocardiography: recording of magnetic heart activity~postnatal ECG: postnatal ECG~fetal echocardiography: fetal echocardiography"
117007|NCT01903564|O1|Outcome|Normal|"pregnant women with uncomplicated pregnancies~magnetocardiography: recording of magnetic heart activity~fetal echocardiography: fetal echocardiography"
117008|NCT01903564|O2|Outcome|High-risk|"pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia~magnetocardiography: recording of magnetic heart activity~postnatal ECG: postnatal ECG~fetal echocardiography: fetal echocardiography"
117009|NCT01903564|O1|Outcome|Normal|"pregnant women with uncomplicated pregnancies~magnetocardiography: recording of magnetic heart activity~fetal echocardiography: fetal echocardiography"
117010|NCT01903564|O2|Outcome|High-risk|"pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia~magnetocardiography: recording of magnetic heart activity~postnatal ECG: postnatal ECG~fetal echocardiography: fetal echocardiography"
117011|NCT01903564|O1|Outcome|Normal|"pregnant women with uncomplicated pregnancies~magnetocardiography: recording of magnetic heart activity~fetal echocardiography: fetal echocardiography"
117012|NCT01903564|O2|Outcome|High-risk|"pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia~magnetocardiography: recording of magnetic heart activity~postnatal ECG: postnatal ECG~fetal echocardiography: fetal echocardiography"
117013|NCT01903564|O1|Outcome|Normal|"pregnant women with uncomplicated pregnancies~magnetocardiography: recording of magnetic heart activity~fetal echocardiography: fetal echocardiography"
117014|NCT01903564|E2|Reported Event|High-risk|"pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia~magnetocardiography: recording of magnetic heart activity~postnatal ECG: postnatal ECG~fetal echocardiography: fetal echocardiography"
117015|NCT01903564|E1|Reported Event|Normal|"pregnant women with uncomplicated pregnancies~magnetocardiography: recording of magnetic heart activity~fetal echocardiography: fetal echocardiography"
117016|NCT01903460|B5|Baseline|Total|Total of all reporting groups
117017|NCT01903460|B4|Baseline|Placebo Cohort B|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
117018|NCT01903460|B3|Baseline|Placebo Cohort A|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
117019|NCT01903460|B2|Baseline|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
117020|NCT01903460|B1|Baseline|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
117021|NCT01903460|P4|Participant Flow|Placebo Cohort B|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
117022|NCT01903460|P3|Participant Flow|Placebo Cohort A|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
117023|NCT01903460|P2|Participant Flow|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
117024|NCT01903460|P1|Participant Flow|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
117025|NCT01903460|O4|Outcome|Placebo Overall|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
117026|NCT01903460|O3|Outcome|LUM001 Overall|Participants received either dose of LUM001 for up to 10 or 13 weeks, then were followed for 4 weeks after treatment.
117027|NCT01903460|O2|Outcome|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
117028|NCT01903460|O1|Outcome|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
117029|NCT01903460|O4|Outcome|Placebo Overall|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
117030|NCT01903460|O3|Outcome|LUM001 Overall|Participants received either dose of LUM001 for up to 10 or 13 weeks, then were followed for 4 weeks after treatment.
117031|NCT01903460|O2|Outcome|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
117032|NCT01903460|O1|Outcome|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
117033|NCT01903460|O4|Outcome|Placebo Overall|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
117034|NCT01903460|O3|Outcome|LUM001 Overall|Participants received either dose of LUM001 for up to 10 or 13 weeks, then were followed for 4 weeks after treatment.
117035|NCT01903460|O2|Outcome|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
117036|NCT01903460|O1|Outcome|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
117037|NCT01903460|E3|Reported Event|Placebo Overall|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
117038|NCT01903460|E2|Reported Event|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
117039|NCT01903460|E1|Reported Event|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
117040|NCT01903265|B3|Baseline|Total|Total of all reporting groups
117041|NCT01903265|B2|Baseline|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.~Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks. (One patient randomized in error never received study drug and therefore is not included in this table.)"
117042|NCT01903265|B1|Baseline|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.~TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
117043|NCT01903265|P2|Participant Flow|Placebo|1 tablet of placebo sublingually each day at bedtime for 12 weeks.
117044|NCT01903265|P1|Participant Flow|TNX-102 SL 2.8 mg|1 tablet of TNX-102 SL sublingually each day at bedtime for 12 weeks
117045|NCT01903265|O2|Outcome|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.~Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
117046|NCT01903265|O1|Outcome|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.~TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
117047|NCT01903265|O2|Outcome|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.~Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
117048|NCT01903265|O1|Outcome|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.~TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
117049|NCT01903265|O2|Outcome|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.~Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
117050|NCT01903265|O1|Outcome|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.~TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
117051|NCT01903265|O2|Outcome|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.~Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
117052|NCT01903265|O1|Outcome|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.~TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
117053|NCT01903265|O2|Outcome|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.~Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
117054|NCT01903265|O1|Outcome|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.~TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
117055|NCT01903265|E2|Reported Event|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.~Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
117056|NCT01903265|E1|Reported Event|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.~TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
117057|NCT01903187|B3|Baseline|Total|Total of all reporting groups
117058|NCT01903187|B2|Baseline|Sham Procedure|"Sham procedure~Sham: Renal artery angiogram"
117059|NCT01903187|B1|Baseline|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
117060|NCT01903187|P2|Participant Flow|Sham Procedure|"Sham procedure~Sham: Renal artery angiogram"
117061|NCT01903187|P1|Participant Flow|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
117062|NCT01903187|O2|Outcome|Sham|Renal artery angiogram without renal denervation
117063|NCT01903187|O1|Outcome|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
117064|NCT01903187|O1|Outcome|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
117065|NCT01903187|O1|Outcome|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
117066|NCT01903187|O1|Outcome|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
117067|NCT01903187|O2|Outcome|Sham Procedure|"Sham procedure~Sham: Renal artery angiogram"
117068|NCT01903187|O1|Outcome|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
117069|NCT01903187|O1|Outcome|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
117070|NCT01903187|E2|Reported Event|Sham Procedure|"Sham procedure~Sham: Renal artery angiogram~Subjects exited after 1 month follow up"
117071|NCT01903187|E1|Reported Event|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
117072|NCT01903148|B3|Baseline|Total|Total of all reporting groups
117073|NCT01903148|B2|Baseline|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
117074|NCT01903148|B1|Baseline|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
117075|NCT01903148|P1|Participant Flow|Patients With Anemia and CKD|Adults patients with anemia secondary to chronic kidney disease (CKD) not on dialysis.
117076|NCT01903148|O2|Outcome|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
117077|NCT01903148|O1|Outcome|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
117078|NCT01903148|O2|Outcome|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
117079|NCT01903148|O1|Outcome|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
117080|NCT01903148|O2|Outcome|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
117081|NCT01903148|O1|Outcome|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
117082|NCT01903148|O2|Outcome|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
117083|NCT01903148|O1|Outcome|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
117084|NCT01903148|O2|Outcome|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
117085|NCT01903148|O1|Outcome|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
117086|NCT01903148|O2|Outcome|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
117087|NCT01903148|O1|Outcome|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
117088|NCT01903148|E2|Reported Event|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
117089|NCT01903148|E1|Reported Event|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
117090|NCT01903031|B4|Baseline|Total|Total of all reporting groups
117091|NCT01903031|B3|Baseline|NuvaRing With ATV/r Plus TDF and ≥1 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received ATV/r 300 mg/ 100 mg daily with tenofovir (TDF) 300 mg and 1 or more additional NRTIs.
117092|NCT01903031|B2|Baseline|NuvaRing With EFV Plus ≥2 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received EFV 600 mg daily with two or more NRTIs.
117093|NCT01903031|B1|Baseline|NuvaRing and no ART|Participants who were not on ART were prescribed NuvaRing, to be inserted at entry and removed at Day 21.
117094|NCT01903031|P3|Participant Flow|NuvaRing With ATV/r Plus TDF and ≥1 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received ATV/r 300 mg/ 100 mg daily with tenofovir (TDF) 300 mg and 1 or more additional NRTIs.
117095|NCT01903031|P2|Participant Flow|NuvaRing With EFV Plus ≥2 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received EFV 600 mg daily with two or more NRTIs.
117096|NCT01903031|P1|Participant Flow|NuvaRing and no ART|Participants who were not on ART were prescribed NuvaRing, to be inserted at entry and removed at Day 21.
117097|NCT01903031|O3|Outcome|NuvaRing With ATV/r Plus TDF and ≥1 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received ATV/r 300 mg/ 100 mg daily with tenofovir (TDF) 300 mg and 1 or more additional NRTIs.
117098|NCT01903031|O2|Outcome|NuvaRing With EFV Plus ≥2 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received EFV 600 mg daily with two or more NRTIs.
117099|NCT01903031|O1|Outcome|NuvaRing and no ART|Participants who were not on ART were prescribed NuvaRing, to be inserted at entry and removed at Day 21.
117100|NCT01903031|O3|Outcome|NuvaRing With ATV/r Plus TDF and ≥1 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received ATV/r 300 mg/ 100 mg daily with tenofovir (TDF) 300 mg and 1 or more additional NRTIs.
117101|NCT01903031|O2|Outcome|NuvaRing With EFV Plus ≥2 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received EFV 600 mg daily with two or more NRTIs.
117102|NCT01903031|O1|Outcome|NuvaRing and no ART|Participants who were not on ART were prescribed NuvaRing, to be inserted at entry and removed at Day 21.
117103|NCT01903031|O3|Outcome|NuvaRing With ATV/r Plus TDF and ≥1 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received ATV/r 300 mg/ 100 mg daily with tenofovir (TDF) 300 mg and 1 or more additional NRTIs.
136504|NCT01806857|O2|Outcome|Matching Placebo|
117104|NCT01903031|O2|Outcome|NuvaRing With EFV Plus ≥2 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received EFV 600 mg daily with two or more NRTIs.
117105|NCT01903031|O1|Outcome|NuvaRing and no ART|Participants who were not on ART were prescribed NuvaRing, to be inserted at entry and removed at Day 21.
117106|NCT01903031|O3|Outcome|NuvaRing With ATV/r Plus TDF and ≥1 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received ATV/r 300 mg/ 100 mg daily with tenofovir (TDF) 300 mg and 1 or more additional NRTIs.
117107|NCT01903031|O2|Outcome|NuvaRing With EFV Plus ≥2 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received EFV 600 mg daily with two or more NRTIs.
117108|NCT01903031|O1|Outcome|NuvaRing and no ART|Participants who were not on ART were prescribed NuvaRing, to be inserted at entry and removed at Day 21.
117109|NCT01903031|O3|Outcome|NuvaRing With ATV/r Plus TDF and ≥1 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received ATV/r 300 mg/ 100 mg daily with tenofovir (TDF) 300 mg and 1 or more additional NRTIs.
117110|NCT01903031|O2|Outcome|NuvaRing With EFV Plus ≥2 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received EFV 600 mg daily with two or more NRTIs.
117111|NCT01903031|O1|Outcome|NuvaRing and no ART|Participants who were not on ART were prescribed NuvaRing, to be inserted at entry and removed at Day 21.
117112|NCT01903031|O3|Outcome|NuvaRing With ATV/r Plus TDF and ≥1 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received ATV/r 300 mg/ 100 mg daily with tenofovir (TDF) 300 mg and 1 or more additional NRTIs.
117113|NCT01903031|O2|Outcome|NuvaRing With EFV Plus ≥2 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received EFV 600 mg daily with two or more NRTIs.
117114|NCT01903031|O1|Outcome|NuvaRing and no ART|Participants who were not on ART were prescribed NuvaRing, to be inserted at entry and removed at Day 21.
117115|NCT01903031|O3|Outcome|NuvaRing With ATV/r Plus TDF and ≥1 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received ATV/r 300 mg/ 100 mg daily with tenofovir (TDF) 300 mg and 1 or more additional NRTIs.
117116|NCT01903031|O2|Outcome|NuvaRing With EFV Plus ≥2 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received EFV 600 mg daily with two or more NRTIs.
117117|NCT01903031|O1|Outcome|NuvaRing and no ART|Participants who were not on ART were prescribed NuvaRing, to be inserted at entry and removed at Day 21.
117118|NCT01903031|E3|Reported Event|NuvaRing With ATV/r Plus TDF and ≥1 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received ATV/r 300 mg/ 100 mg daily with tenofovir (TDF) 300 mg and 1 or more additional NRTIs.
117119|NCT01903031|E2|Reported Event|NuvaRing With EFV Plus ≥2 NRTIs|NuvaRing was inserted at entry and removed at Day 21. Participants also received EFV 600 mg daily with two or more NRTIs.
117120|NCT01903031|E1|Reported Event|NuvaRing and no ART|Participants who were not on ART were prescribed NuvaRing, to be inserted at entry and removed at Day 21.
117121|NCT01903005|B3|Baseline|Total|Total of all reporting groups
117122|NCT01903005|B2|Baseline|OX219-007 Completers|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg and 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
117123|NCT01903005|B1|Baseline|OX219-006 Completers|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg and 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
117124|NCT01903005|P1|Participant Flow|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
117125|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
117126|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
117127|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
117128|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
117129|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
117130|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
117131|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
117132|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
117133|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
117134|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
117172|NCT01902303|B1|Baseline|Matching Placebo|Placebo Safety Population - All subjects enrolled and received placebo test article
117135|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
117136|NCT01903005|E1|Reported Event|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses of buprenorphine/naloxone between 5.7/1.4 mg and 17.1/4.2 mg mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
117137|NCT01902888|B1|Baseline|Popliteal Aneurysm|"GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm~GORE® VIABAHN® Endoprosthesis"
117138|NCT01902888|P1|Participant Flow|Popliteal Aneurysm|"GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm~GORE® VIABAHN® Endoprosthesis"
117139|NCT01902888|O1|Outcome|Popliteal Aneurysm|"GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm~GORE® VIABAHN® Endoprosthesis"
117140|NCT01902888|O1|Outcome|Popliteal Aneurysm|"GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm~GORE® VIABAHN® Endoprosthesis"
117141|NCT01902888|E1|Reported Event|Popliteal Aneurysm|"GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm~GORE® VIABAHN® Endoprosthesis"
117142|NCT01902758|B3|Baseline|Total|Total of all reporting groups
117143|NCT01902758|B2|Baseline|Placebo|"matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group~placebo: placebo for comparison group"
117144|NCT01902758|B1|Baseline|Ambrisentan and Theophylline|"ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days~ambrisentan and theophylline"
117145|NCT01902758|P2|Participant Flow|Placebo|"matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group~placebo: placebo for comparison group"
117146|NCT01902758|P1|Participant Flow|Ambrisentan and Theophylline|"ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days~ambrisentan and theophylline"
117147|NCT01902758|O2|Outcome|Placebo|"matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group~placebo: placebo for comparison group"
117148|NCT01902758|O1|Outcome|Ambrisentan and Theophylline|"ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days~ambrisentan and theophylline"
117149|NCT01902758|E2|Reported Event|Placebo|"matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group~placebo: placebo for comparison group"
117150|NCT01902758|E1|Reported Event|Ambrisentan and Theophylline|"ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days~ambrisentan and theophylline"
117151|NCT01902459|B3|Baseline|Total|Total of all reporting groups
117152|NCT01902459|B2|Baseline|Standard of Care (SoC)|Manual compression with or without a topical absorbable hemostat
117153|NCT01902459|B1|Baseline|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
117154|NCT01902459|P2|Participant Flow|Standard of Care (SoC)|Manual compression with or without a topical absorbable hemostat
117155|NCT01902459|P1|Participant Flow|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
117156|NCT01902459|O2|Outcome|Standard of Care (SoC)|Manual compression with or without a topical absorbable hemostat
117157|NCT01902459|O1|Outcome|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
117158|NCT01902459|O2|Outcome|Standard of Care (SoC)|Manual compression with or without a topical absorbable hemostat
117159|NCT01902459|O1|Outcome|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
117160|NCT01902459|O2|Outcome|Standard of Care (SoC)|Manual compression with or without a topical absorbable hemostat
117161|NCT01902459|O1|Outcome|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
117162|NCT01902459|O2|Outcome|Standard of Care (SoC)|Manual compression with or without a topical absorbable hemostat
117163|NCT01902459|O1|Outcome|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
117164|NCT01902459|O2|Outcome|Standard of Care (SoC)|Manual compression with or without a topical absorbable hemostat
117165|NCT01902459|O1|Outcome|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
117166|NCT01902459|O2|Outcome|Standard of Care (SoC)|Manual compression with or without a topical absorbable hemostat
117167|NCT01902459|O1|Outcome|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
117168|NCT01902459|E2|Reported Event|Standard of Care (SoC)|Manual compression with or without a topical absorbable hemostat
117169|NCT01902459|E1|Reported Event|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
117170|NCT01902303|B3|Baseline|Total|Total of all reporting groups
117171|NCT01902303|B2|Baseline|BTL-TML-HSV Active Treatment|BTL-TML Safety Population - All subjects enrolled and received active test article
120656|NCT01882647|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
117173|NCT01902303|P2|Participant Flow|BTL-TML-HSV|"Experimental Product~BTL-TML-HSV: Sublingual micro dosing of BTL-TML-HSV for 7 days~Treatment regimens will be as follows (upon the first signs/symptoms of prodrome (tingling, itching, burning):~Day 0 – Take 1 drop every 10 minutes for the 1st hour following appearance of prodrome symptoms (0, 10, 20, 30, 40, 50 and 60 minutes), then 1 drop every hour until bedtime.~Days 1 & 2 – Take 1 drop six times daily –~Days 3-7 – Take one drop twice daily"
117174|NCT01902303|P1|Participant Flow|Matching Placebo|"Matching Placebo~Treatment regimens will be as follows (upon the first signs/symptoms of prodrome (tingling, itching, burning):~Day 0 – Take 1 drop every 10 minutes for the 1st hour following appearance of prodrome symptoms (0, 10, 20, 30, 40, 50 and 60 minutes), then 1 drop every hour until bedtime.~Days 1 & 2 – Take 1 drop six times daily –~Days 3-7 – Take one drop twice daily"
117175|NCT01902303|O2|Outcome|BTL-TML-HSV Active Treatment|BTL-TML Efficacy Population - All subjects who received active test article and were compliant with protocol
117176|NCT01902303|O1|Outcome|Matching Placebo|Placebo efficacy Population - All subjects who received placebo test article and were compliant with protocol
117177|NCT01902303|O2|Outcome|BTL-TML-HSV Active Treatment|BTL-TML Efficacy Population - All subjects enrolled and received active test article and met Per Protocol definition
117178|NCT01902303|O1|Outcome|Matching Placebo|Placebo Efficacy Population - All subjects enrolled and received placebo test article and met Per protocol definition
117179|NCT01902303|E2|Reported Event|BTL-TML-HSV Active Treatment|BTL-TML Safety Population - All subjects enrolled and allocated to active test article except for SAEs which includes all subjects that signed informed consent.
117180|NCT01902303|E1|Reported Event|Matching Placebo|Placebo Safety Population - All subjects that enrolled and were allocated to placebo test article except for SAEs and that includes all subjects that signed informed consent.
117181|NCT01902134|B7|Baseline|Total|Total of all reporting groups
117182|NCT01902134|B6|Baseline|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses
117183|NCT01902134|B5|Baseline|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses
117184|NCT01902134|B4|Baseline|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
117185|NCT01902134|B3|Baseline|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses
117186|NCT01902134|B2|Baseline|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
117187|NCT01902134|B1|Baseline|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
117188|NCT01902134|P6|Participant Flow|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses
117189|NCT01902134|P5|Participant Flow|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses Placebo followed by DKP
117190|NCT01902134|P4|Participant Flow|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
117191|NCT01902134|P3|Participant Flow|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses
117192|NCT01902134|P2|Participant Flow|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
117193|NCT01902134|P1|Participant Flow|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
117194|NCT01902134|O4|Outcome|PLACEBO|Drug: Placebo; Arm type: PLACEBO comparator; Placebo single oral dose during single dose phase (first 8 hours);
117195|NCT01902134|O3|Outcome|TRAMADOL|Drug: Tramadol single oral dose (first 8 hours); Arm type: active comparator; Tramadol single oral dose (first 8 hours);
117196|NCT01902134|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen single oral dose (first 8 hours); Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours);
117197|NCT01902134|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours); Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours);
117198|NCT01902134|O3|Outcome|TRAMADOL|Drug: Tramadol multiple doses; Arm type: active comparator; Tramadol multiple oral doses t.i.d. for 5 days (a total of 12 doses)
117199|NCT01902134|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen multiple doses; Arm type: active comparator; Dexketoprofen multiple oral doses t.i.d. for 5 days (a total of 12 doses)
117200|NCT01902134|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol multiple doses; Arm type: experimental; Dexketoprofen/Tramadol multiple oral doses t.i.d. for 5 days (a total of 12 doses)
117201|NCT01902134|O3|Outcome|TRAMADOL|Drug: Tramadol multiple doses; Arm type: active comparator; Tramadol multiple oral doses t.i.d. for 5 days (a total of 12 doses)
117202|NCT01902134|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen multiple doses; Arm type: active comparator; Dexketoprofen multiple oral doses t.i.d. for 5 days (a total of 12 doses)
117203|NCT01902134|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol multiple doses; Arm type: experimental; Dexketoprofen/Tramadol multiple oral doses t.i.d. for 5 days (a total of 12 doses)
117204|NCT01902134|O4|Outcome|PLACEBO|Drug: Placebo; Arm type: PLACEBO comparator; Placebo single oral dose (first 8 hours);
117205|NCT01902134|O3|Outcome|TRAMADOL|Drug: Tramadol single oral dose (first 8 hours); Arm type: active comparator; Tramadol single oral dose (first 8 hours);
117206|NCT01902134|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen single oral dose (first 8 hours); Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours);
117207|NCT01902134|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours); Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours);
117208|NCT01902134|E6|Reported Event|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses.
117209|NCT01902134|E5|Reported Event|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses.
117210|NCT01902134|E4|Reported Event|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses.
117211|NCT01902134|E3|Reported Event|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses.
117212|NCT01902134|E2|Reported Event|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses.
117213|NCT01902134|E1|Reported Event|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses.
117214|NCT01901809|B5|Baseline|Total|Total of all reporting groups
117215|NCT01901809|B4|Baseline|Continuous Furosemide Plus Dopamine|"Continuous furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min administered as an infusion.~Furosemide~Dopamine"
117216|NCT01901809|B3|Baseline|Bolus Furosemide Plus Dopamine|"Intermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min administered as an infusion.~Furosemide~Dopamine"
117217|NCT01901809|B2|Baseline|Continuous Infusion Furosemide|"If the patient is not on a prior diuretic dose, a standard dose of furosemide 80mg IV over 24 hrs, will be initiated.~If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose continuously over 24 hrs. . (i.e. if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose would be furosemide 160mg IV to be administered continuously over 24 hrs).~Furosemide"
117218|NCT01901809|B1|Baseline|Bolus Furosemide|"If the patient is not on a prior diuretic dose, a standard dose of furosemide 40mg IV every 12 hrs, with total dose of 80 mg IV over 24 hrs will be initiated.~If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose every 12 hrs. (i.e if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose will be furosemide 80mg IV twice daily).~Furosemide"
117219|NCT01901809|P4|Participant Flow|Continuous Furosemide Plus Dopamine|"Continuous furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min administered as an infusion.~Furosemide~Dopamine"
117220|NCT01901809|P3|Participant Flow|Bolus Furosemide Plus Dopamine|"Intermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min administered as an infusion.~Furosemide~Dopamine"
117221|NCT01901809|P2|Participant Flow|Continuous Infusion Furosemide|"If the patient is not on a prior diuretic dose, a standard dose of furosemide 80mg IV over 24 hrs, will be initiated.~If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose continuously over 24 hrs. . (i.e. if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose would be furosemide 160mg IV to be administered continuously over 24 hrs).~Furosemide"
117222|NCT01901809|P1|Participant Flow|Bolus Furosemide|"If the patient is not on a prior diuretic dose, a standard dose of furosemide 40mg IV every 12 hrs, with total dose of 80 mg IV over 24 hrs will be initiated.~If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose every 12 hrs. (i.e if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose will be furosemide 80mg IV twice daily).~Furosemide"
117223|NCT01901809|O2|Outcome|No Dopamine|Diuretic therapy only
117224|NCT01901809|O1|Outcome|Dopamine|Diuretic therapy plus addition of dopamine at 3 µg/kg/min administered as an infusion.
117225|NCT01901809|O2|Outcome|Continuous Infusion Furosemide|"If the patient is not on a prior diuretic dose, a standard dose of furosemide 80mg IV over 24 hrs, will be initiated.~If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose continuously over 24 hrs. . (i.e. if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose would be furosemide 160mg IV to be administered continuously over 24 hrs)."
117226|NCT01901809|O1|Outcome|Bolus Furosemide|"If the patient is not on a prior diuretic dose, a standard dose of furosemide 40mg IV every 12 hrs, with total dose of 80 mg IV over 24 hrs will be initiated.~If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose every 12 hrs. (i.e if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose will be furosemide 80mg IV twice daily)."
117227|NCT01901809|O4|Outcome|Continuous Furosemide Plus Dopamine|"Continuous furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min~Furosemide~Dopamine"
117228|NCT01901809|O3|Outcome|Bolus Furosemide Plus Dopamine|"Intermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min~Furosemide~Dopamine"
117229|NCT01901809|O2|Outcome|Continuous Infusion Furosemide and no Dopamine|"If the patient is not on a prior diuretic dose, a standard dose of furosemide 80mg IV over 24 hrs, will be initiated.~If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose continuously over 24 hrs. . (i.e. if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose would be furosemide 160mg IV to be administered continuously over 24 hrs).~Furosemide"
117230|NCT01901809|O1|Outcome|Bolus Furosemide and no Dopamine|"If the patient is not on a prior diuretic dose, a standard dose of furosemide 40mg IV every 12 hrs, with total dose of 80 mg IV over 24 hrs will be initiated.~If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose every 12 hrs. (i.e if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose will be furosemide 80mg IV twice daily).~Furosemide"
117231|NCT01901809|E4|Reported Event|Continuous Furosemide Plus Dopamine|"Continuous furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min administered as an infusion.~Furosemide~Dopamine"
117232|NCT01901809|E3|Reported Event|Bolus Furosemide Plus Dopamine|"Intermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min administered as an infusion.~Furosemide~Dopamine"
117233|NCT01901809|E2|Reported Event|Continuous Infusion Furosemide|"If the patient is not on a prior diuretic dose, a standard dose of furosemide 80mg IV over 24 hrs, will be initiated.~If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose continuously over 24 hrs. . (i.e. if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose would be furosemide 160mg IV to be administered continuously over 24 hrs).~Furosemide"
117234|NCT01901809|E1|Reported Event|Bolus Furosemide|"If the patient is not on a prior diuretic dose, a standard dose of furosemide 40mg IV every 12 hrs, with total dose of 80 mg IV over 24 hrs will be initiated.~If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose every 12 hrs. (i.e if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose will be furosemide 80mg IV twice daily).~Furosemide"
117235|NCT01901588|B3|Baseline|Total|Total of all reporting groups
117236|NCT01901588|B2|Baseline|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
117237|NCT01901588|B1|Baseline|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
117239|NCT01901588|P1|Participant Flow|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
117240|NCT01901588|O2|Outcome|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
117241|NCT01901588|O1|Outcome|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
117242|NCT01901588|O2|Outcome|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
117243|NCT01901588|O1|Outcome|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
117244|NCT01901588|O2|Outcome|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
117245|NCT01901588|O1|Outcome|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
117246|NCT01901588|O2|Outcome|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
117247|NCT01901588|O1|Outcome|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
117248|NCT01901588|O2|Outcome|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
117249|NCT01901588|O1|Outcome|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
117250|NCT01901588|O2|Outcome|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
117251|NCT01901588|O1|Outcome|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
117252|NCT01901588|E2|Reported Event|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
117253|NCT01901588|E1|Reported Event|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
117254|NCT01901575|B1|Baseline|Remifentanil|Remifentanil IV PCA
117255|NCT01901575|P1|Participant Flow|Remifentanil IV PCA|Patients with established PVC's sedated with remifentanil IVPCA per study protocol
117256|NCT01901575|O1|Outcome|Remifentanil IV PCA|"patients with PVC's prior to administration of remifentanil~Remifentanil: Patients with established PVC's , sedated with remifentanil IVPCA per study protocol"
117257|NCT01901575|O1|Outcome|Remifentanil IV PCA|Patients with established PVC's sedated with remifentanil IVPCA per study protocol
117258|NCT01901575|E1|Reported Event|Remifentanil IV PCA|Patients with established PVC's sedated with remifentanil IVPCA per study protocol
117259|NCT01901393|B3|Baseline|Total|Total of all reporting groups
117260|NCT01901393|B2|Baseline|Ketorolac|"30mg ketorolac~Ketorolac"
117261|NCT01901393|B1|Baseline|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
117262|NCT01901393|P2|Participant Flow|Ketorolac|"30mg ketorolac~Ketorolac"
117263|NCT01901393|P1|Participant Flow|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
117264|NCT01901393|O2|Outcome|Ketorolac|"30mg ketorolac~Ketorolac"
117265|NCT01901393|O1|Outcome|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
117266|NCT01901393|O2|Outcome|Ketorolac|"30mg ketorolac~Ketorolac"
117267|NCT01901393|O1|Outcome|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
117268|NCT01901393|O2|Outcome|Ketorolac|"30mg ketorolac~Ketorolac"
117269|NCT01901393|O1|Outcome|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
117270|NCT01901393|O2|Outcome|Ketorolac|"30mg ketorolac~Ketorolac"
117271|NCT01901393|O1|Outcome|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
117272|NCT01901393|O2|Outcome|Ketorolac|"30mg ketorolac~Ketorolac"
117273|NCT01901393|O1|Outcome|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
117274|NCT01901393|O2|Outcome|Ketorolac|"30mg ketorolac~Ketorolac"
117275|NCT01901393|O1|Outcome|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
117276|NCT01901393|E2|Reported Event|Ketorolac|"30mg ketorolac~Ketorolac"
117277|NCT01901393|E1|Reported Event|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
117278|NCT01901341|B3|Baseline|Total|Total of all reporting groups
117279|NCT01901341|B2|Baseline|Placebo|Placebo administered orally BID for a 12-week treatment period
117280|NCT01901341|B1|Baseline|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
117281|NCT01901341|P2|Participant Flow|Placebo|Placebo administered orally BID for a 12-week treatment period
117282|NCT01901341|P1|Participant Flow|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
117283|NCT01901341|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
117284|NCT01901341|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
117285|NCT01901341|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
117286|NCT01901341|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
117287|NCT01901341|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
117288|NCT01901341|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
117289|NCT01901341|O2|Outcome|Placebo|Placebo administered orally BID for a12-week treatment period
117290|NCT01901341|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
117291|NCT01901341|E2|Reported Event|Placebo|Placebo administered orally BID for a 12-week treatment period
117292|NCT01901341|E1|Reported Event|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
117293|NCT01901328|B3|Baseline|Total|Total of all reporting groups
117294|NCT01901328|B2|Baseline|Placebo|Placebo administered orally BID for a 12-week treatment period
117295|NCT01901328|B1|Baseline|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
117296|NCT01901328|P2|Participant Flow|Placebo|Placebo administered orally BID for a 12-week treatment period
117297|NCT01901328|P1|Participant Flow|CB-5945|0.25 milligrams (mg) CB-5945 administered orally twice dailly (BID) for a 12-week treatment period
117298|NCT01901328|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
117301|NCT01901328|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
117302|NCT01901328|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
117303|NCT01901328|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
117304|NCT01901328|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
117305|NCT01901328|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
117306|NCT01901328|E2|Reported Event|Placebo|Placebo administered orally BID for a 12-week treatment period
117307|NCT01901328|E1|Reported Event|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
117308|NCT01901302|B3|Baseline|Total|Total of all reporting groups
117309|NCT01901302|B2|Baseline|Placebo|Placebo administered orally BID for a 12-week treatment period
117310|NCT01901302|B1|Baseline|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
117311|NCT01901302|P2|Participant Flow|Placebo|Placebo administered orally BID for a 12-week treatment period
117312|NCT01901302|P1|Participant Flow|CB-5945|0.25 milligrams (mg) CB-5945 administered orally twice daily (BID) for a 12-week treatment period
117313|NCT01901302|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
117314|NCT01901302|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
117315|NCT01901302|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
117316|NCT01901302|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
117317|NCT01901302|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
117318|NCT01901302|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
117319|NCT01901302|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
117320|NCT01901302|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
117321|NCT01901302|E2|Reported Event|Placebo|Placebo administered orally BID for a 12-week treatment period
117322|NCT01901302|E1|Reported Event|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
117323|NCT01901250|B3|Baseline|Total|Total of all reporting groups
117324|NCT01901250|B2|Baseline|Fiber GB|"Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Sugar free fiber gummy bears: The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
117325|NCT01901250|B1|Baseline|Xylitol GB|"Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Xylitol gummy bears: The children receive xylitol gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
117326|NCT01901250|P2|Participant Flow|Fiber GB|"Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Sugar free fiber gummy bears: The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
117327|NCT01901250|P1|Participant Flow|Xylitol GB|"Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Xylitol gummy bears: The children receive xylitol gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
117328|NCT01901250|O2|Outcome|Fiber GB|"Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Sugar free fiber gummy bears: The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
117329|NCT01901250|O1|Outcome|Xylitol GB|"Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Xylitol gummy bears: The children receive xylitol gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
117352|NCT01901211|O2|Outcome|Comparison Arm|"In this arm of the study, participants will engage in their typical physical activity routines for the ten week duration in either the first or the last part of the study.~Participants will receive a call from the RA each week. The RA will ask the child to report on all the physical and social activities that they engaged in for that week."
117330|NCT01901250|E2|Reported Event|Fiber GB|"Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Sugar free fiber gummy bears: The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
117331|NCT01901250|E1|Reported Event|Xylitol GB|"Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Xylitol gummy bears: The children receive xylitol gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
117332|NCT01901211|B3|Baseline|Total|Total of all reporting groups
117333|NCT01901211|B2|Baseline|Comparison First, Then Exergaming|"In this arm of the study, participants will complete comparison activities during the first ten-week then after 6-week washout, will participate in the exergaming intervention during the second ten-week period.~Participants will engage in their typical physical activity routines for the ten week duration. Participants will receive a call from the RA each week. The RA will ask the child to report on all the physical and social activities that they engaged in for that week."
117334|NCT01901211|B1|Baseline|Exergaming First, Then Comparison|"In this arm, the participants will participate in the exergaming intervention during the first ten-week then after 6-week washout, will participate in the comparison activities during the second ten-week period.~Exergaming Intervention: The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues."
117335|NCT01901211|P2|Participant Flow|Comparison First, Then Exergaming|"In this arm of the study, participants will participate in comparison activities during the first ten-week period then after 6-week washout, will participate in the Exergaming activities during the second ten-week period.~participants will engage in their typical physical activity routines for the ten week duration. Participants will receive a call from the RA each week. The RA will ask the child to report on all the physical and social activities that they engaged in for that week."
117336|NCT01901211|P1|Participant Flow|Exergaming First, Then Comparison|"In this arm, the participants will participate in the exergaming intervention during the first ten-week period then after 6-week washout, will participate in the comparison during the second ten-week period.~Exergaming Intervention: The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues."
117337|NCT01901211|O2|Outcome|Comparison Arm|"In this arm of the study, participants will engage in their typical physical activity routines for the ten week duration in either the first or the last part of the study.~Participants will receive a call from the RA each week. The RA will ask the child to report on all the physical and social activities that they engaged in for that week."
117338|NCT01901211|O1|Outcome|Exergaming|"In this arm, the participants will participate in the exergaming intervention in either the first or the last part of the study.~Exergaming Intervention: The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues."
117339|NCT01901211|O2|Outcome|Comparison Arm|"In this arm of the study, participants will engage in their typical physical activity routines for the ten week duration in either the first or the last part of the study.~Participants will receive a call from the RA each week. The RA will ask the child to report on all the physical and social activities that they engaged in for that week."
117340|NCT01901211|O1|Outcome|Exergaming|"In this arm, the participants will participate in the exergaming intervention in either the first or the last part of the study.~Exergaming Intervention: The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues."
117372|NCT01900665|O2|Outcome|Placebo|Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
117341|NCT01901211|O1|Outcome|Exergaming|"In this arm, the participants will participate in the exergaming intervention in either the first or the last part of the study.~Exergaming Intervention: The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues."
117342|NCT01901211|O2|Outcome|Comparison Arm|"In this arm of the study, participants will engage in their typical physical activity routines for the ten week duration in either the first or the last part of the study.~Participants will receive a call from the RA each week. The RA will ask the child to report on all the physical and social activities that they engaged in for that week."
117343|NCT01901211|O1|Outcome|Exergaming|"In this arm, the participants will participate in the exergaming intervention in either the first or the last part of the study.~Exergaming Intervention: The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues."
117344|NCT01901211|O2|Outcome|Comparison Arm|"In this arm of the study, participants will engage in their typical physical activity routines for the ten week duration in either the first or the last part of the study.~Participants will receive a call from the RA each week. The RA will ask the child to report on all the physical and social activities that they engaged in for that week."
117345|NCT01901211|O1|Outcome|Exergaming|"In this arm, the participants will participate in the exergaming intervention in either the first or the last part of the study.~Exergaming Intervention: The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues."
117346|NCT01901211|O2|Outcome|Comparison Arm|"In this arm of the study, participants will engage in their typical physical activity routines for the ten week duration in either the first or the last part of the study.~Participants will receive a call from the RA each week. The RA will ask the child to report on all the physical and social activities that they engaged in for that week."
117347|NCT01901211|O1|Outcome|Exergaming|"In this arm, the participants will participate in the exergaming intervention in either the first or the last part of the study.~Exergaming Intervention: The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues."
117348|NCT01901211|O2|Outcome|Comparison Arm|"In this arm of the study, participants will engage in their typical physical activity routines for the ten week duration in either the first or the last part of the study.~Participants will receive a call from the RA each week. The RA will ask the child to report on all the physical and social activities that they engaged in for that week."
117349|NCT01901211|O1|Outcome|Exergaming|"In this arm, the participants will participate in the exergaming intervention in either the first or the last part of the study.~Exergaming Intervention: The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues."
117350|NCT01901211|O2|Outcome|Comparison Arm|"In this arm of the study, participants will engage in their typical physical activity routines for the ten week duration in either the first or the last part of the study.~Participants will receive a call from the RA each week. The RA will ask the child to report on all the physical and social activities that they engaged in for that week."
117351|NCT01901211|O1|Outcome|Exergaming|"In this arm, the participants will participate in the exergaming intervention in either the first or the last part of the study.~Exergaming Intervention: The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues."
120264|NCT01884675|P1|Participant Flow|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
117353|NCT01901211|O1|Outcome|Exergaming|"In this arm, the participants will participate in the exergaming intervention in either the first or the last part of the study.~Exergaming Intervention: The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues."
117354|NCT01901211|O2|Outcome|Comparison Arm|"In this arm of the study, participants will engage in their typical physical activity routines for the ten week duration in either the first or the last part of the study.~Participants will receive a call from the RA each week. The RA will ask the child to report on all the physical and social activities that they engaged in for that week."
117355|NCT01901211|O1|Outcome|Exergaming|"In this arm, the participants will participate in the exergaming intervention in either the first or the last part of the study.~Exergaming Intervention: The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues."
117356|NCT01901211|E2|Reported Event|Comparison Arm|"In this arm of the study, participants will participate in comparison activities during the first ten-week period then after 6-week washout, will participate in the Exergaming activities during the second ten-week period.~participants will engage in their typical physical activity routines for the ten week duration. Participants will receive a call from the RA each week. The RA will ask the child to report on all the physical and social activities that they engaged in for that week."
117357|NCT01901211|E1|Reported Event|Exergaming|"In this arm, the participants will participate in the exergaming intervention during the first ten-week period then after 6-week washout, will participate in the comparison during the second ten-week period.~Exergaming Intervention: The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues."
117358|NCT01901185|B1|Baseline|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
117359|NCT01901185|P1|Participant Flow|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
117360|NCT01901185|O1|Outcome|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
117361|NCT01901185|O1|Outcome|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
117362|NCT01901185|O1|Outcome|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
117363|NCT01901185|O1|Outcome|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
117364|NCT01901185|E1|Reported Event|Autoinjector A/Etanercept|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week at Weeks 1 - 5 (total of 6 injections).
117365|NCT01900665|B3|Baseline|Total|Total of all reporting groups
117366|NCT01900665|B2|Baseline|Placebo|"Placebo every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.~Placebo: Administered IV"
117367|NCT01900665|B1|Baseline|Solanezumab|Participants received Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
117368|NCT01900665|P2|Participant Flow|Placebo|Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
117369|NCT01900665|P1|Participant Flow|Solanezumab|Participants received Solanezumab 400 milligrams (mg)Intravenously (IV) every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
117370|NCT01900665|O2|Outcome|Placebo|Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
117371|NCT01900665|O1|Outcome|Solanezumab|Participants received Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
136505|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
117373|NCT01900665|O1|Outcome|Solanezumab|Participants received Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
117374|NCT01900665|O1|Outcome|Solanezumab|Participants received Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
117375|NCT01900665|O2|Outcome|Placebo|Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
117376|NCT01900665|O1|Outcome|Solanezumab|Participants received Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
117377|NCT01900665|O2|Outcome|Placebo|Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
117378|NCT01900665|O1|Outcome|Solanezumab|Participants received Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
117379|NCT01900665|O2|Outcome|Placebo|Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
117380|NCT01900665|O1|Outcome|Solanezumab|Participants received Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
117381|NCT01900665|O2|Outcome|Placebo|Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
117382|NCT01900665|O1|Outcome|Solanezumab|Participants received Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
117383|NCT01900665|O2|Outcome|Placebo|Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
117384|NCT01900665|O1|Outcome|Solanezumab|Participants received Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
117385|NCT01900665|O2|Outcome|Placebo|Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
117386|NCT01900665|O1|Outcome|Solanezumab|Participants received Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
117387|NCT01900665|O2|Outcome|Placebo|"Placebo every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.~Placebo: Administered IV"
117388|NCT01900665|O1|Outcome|Solanezumab|Participants received Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
117389|NCT01900665|O2|Outcome|Placebo|Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
117390|NCT01900665|O1|Outcome|Solanezumab|Participants received Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
117391|NCT01900665|O2|Outcome|Placebo|Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
117392|NCT01900665|O1|Outcome|Solanezumab|Participants received Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
117393|NCT01900665|O2|Outcome|Placebo|Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
117394|NCT01900665|O1|Outcome|Solanezumab|Participants received Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
117395|NCT01900665|O2|Outcome|Placebo|Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
117468|NCT01900249|O1|Outcome|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution, 0.2%~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks."
117396|NCT01900665|O1|Outcome|Solanezumab|Participants received Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
117397|NCT01900665|O2|Outcome|Placebo|Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
117398|NCT01900665|O1|Outcome|Solanezumab|Participants received Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
117399|NCT01900665|O2|Outcome|Placebo|Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
117400|NCT01900665|O1|Outcome|Solanezumab|Participants received Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
117401|NCT01900665|O2|Outcome|Placebo|Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
117402|NCT01900665|O1|Outcome|Solanezumab|Participants received Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
117403|NCT01900665|O2|Outcome|Placebo|Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
117404|NCT01900665|O1|Outcome|Solanezumab|Participants received Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
117405|NCT01900665|E4|Reported Event|Placebo: Open Label|Participants who complete 80 weeks treatment/assessment of the double-blind period were entered into open-label period. Participants received Placebo IV every 4 weeks for 180 weeks with an additional 4 weeks of assessments.
117406|NCT01900665|E3|Reported Event|Solanezumab: Open Label|Participants who complete 80 weeks treatment/assessment of the double-blind period were entered into open-label period. Participants received Solanezumab 400 mg IV every 4 weeks for 180 weeks with an additional 4 weeks of assessments.
117407|NCT01900665|E2|Reported Event|Placebo: Double-Blind Phase|Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
117408|NCT01900665|E1|Reported Event|Solanezumab: Double-Blind Phase|Participants received Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
117409|NCT01900444|B1|Baseline|Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
117410|NCT01900444|P1|Participant Flow|Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
117411|NCT01900444|O1|Outcome|Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
117412|NCT01900444|O1|Outcome|Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
117413|NCT01900444|O1|Outcome|Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
117414|NCT01900444|O1|Outcome|Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
117415|NCT01900444|O1|Outcome|Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
117416|NCT01900444|O1|Outcome|Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
117417|NCT01900444|O1|Outcome|Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
117418|NCT01900444|O1|Outcome|Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
117419|NCT01900444|E1|Reported Event|Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
117420|NCT01900431|B3|Baseline|Total|Total of all reporting groups
117421|NCT01900431|B2|Baseline|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B) and non-responders were proposed to be treated with open-label Sarilumab 200 mg q2w in open-label treatment period (Part-C).
117440|NCT01900431|O1|Outcome|Placebo (Part A)|Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
120657|NCT01882647|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
117422|NCT01900431|B1|Baseline|Placebo|Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B) and non-responders were proposed to be treated with open-label Sarilumab 200 mg q2w in open-label treatment period (Part-C).
117423|NCT01900431|P3|Participant Flow|Sarilumab 200 mg q2w (Open-Label Treatment)|Non-responders and non-completers observed in Part A were treated with Sarilumab 200 mg SC injection q2w for 34 weeks as open-label treatment in open-label treatment period (Part C) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
117424|NCT01900431|P2|Participant Flow|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B).
117425|NCT01900431|P1|Participant Flow|Placebo|Placebo (for Sarilumab) subcutaneous (SC) injection every 2 weeks (q2w) for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with Methotrexate (MTX) 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B).
117426|NCT01900431|O1|Outcome|Sarilumab 200 mg q2w (Part A + Part B)|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B).
117427|NCT01900431|O2|Outcome|Sarilumab 200 mg q2w (Part A)|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
117428|NCT01900431|O1|Outcome|Placebo (Part A)|Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
117429|NCT01900431|O2|Outcome|Sarilumab 200 mg q2w (Part A)|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
117430|NCT01900431|O1|Outcome|Placebo (Part A)|Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
117431|NCT01900431|O2|Outcome|Sarilumab 200 mg q2w (Part A)|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
117432|NCT01900431|O1|Outcome|Placebo (Part A)|Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
117433|NCT01900431|O2|Outcome|Sarilumab 200 mg q2w (Part A)|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
117434|NCT01900431|O1|Outcome|Placebo (Part A)|Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
117435|NCT01900431|O2|Outcome|Sarilumab 200 mg q2w (Part A)|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
117436|NCT01900431|O1|Outcome|Placebo (Part A)|Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
117437|NCT01900431|O2|Outcome|Sarilumab 200 mg q2w (Part A)|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
117438|NCT01900431|O1|Outcome|Placebo (Part A)|Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
117439|NCT01900431|O2|Outcome|Sarilumab 200 mg q2w (Part A)|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
117467|NCT01900249|O2|Outcome|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5%~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks."
120658|NCT01882647|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
117441|NCT01900431|O2|Outcome|Sarilumab 200 mg q2w (Part A)|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
117442|NCT01900431|O1|Outcome|Placebo (Part A)|Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
117443|NCT01900431|O2|Outcome|Sarilumab 200 mg q2w (Part A)|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
117444|NCT01900431|O1|Outcome|Placebo (Part A)|Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
117445|NCT01900431|E3|Reported Event|Sarilumab 200 mg q2w: Open-Label Treatment (Part C)|Non-responders and non-completers observed in Part A were proposed to be treated with Sarilumab 200 mg SC injection q2w for 34 weeks as open-label treatment in open-label treatment period (Part-C) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
117446|NCT01900431|E2|Reported Event|Sarilumab 200 mg q2w (Part A+ Part B)|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B).
117447|NCT01900431|E1|Reported Event|Placebo (Part A + Part B)|Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B).
117448|NCT01900314|B3|Baseline|Total|Total of all reporting groups
117449|NCT01900314|B2|Baseline|Sham rTMS|20 sham sessions
117450|NCT01900314|B1|Baseline|Active rTMS|20 active sessions
117451|NCT01900314|P2|Participant Flow|Sham rTMS|"20 sham sessions, within a 4 week period, where subjects receive inactive treatments (0 Hz) of repetitive Transcranial Magnetic Stimulation (rTMS). After 20 sessions and completion of a second functional magnetic resonance imaging scan, patients in this group will then be unblinded and transitioned to the active arm and will receive a full course (25 sessions) of active rTMS over a 6 week period.~repetitive Transcranial Magnetic Stimulation (rTMS): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm."
117452|NCT01900314|P1|Participant Flow|Active rTMS|"20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the FDA-approved device label (10 Hz) to a targeted area of the brain. After these sessions, a second functional magnetic resonance imaging scan will be completed then 5 additional tapering treatments of rTMS over a 2 week period.~repetitive Transcranial Magnetic Stimulation (rTMS): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm."
117453|NCT01900314|O2|Outcome|Sham rTMS|20 sham sessions
117454|NCT01900314|O1|Outcome|Active rTMS|20 active sessions
117455|NCT01900314|O2|Outcome|Sham rTMS|20 sham sessions
117456|NCT01900314|O1|Outcome|Active rTMS|20 active sessions of rTMS
117457|NCT01900314|E2|Reported Event|Sham rTMS|"20 sham sessions, within a 4 week period, where subjects receive inactive treatments (0 Hz) of repetitive Transcranial Magnetic Stimulation (rTMS). After 20 sessions and completion of a second fMRI scan, patients in this group will then be unblinded and transitioned to the active arm and will receive a full course (25 sessions) of active rTMS over a 6 week period.~repetitive Transcranial Magnetic Stimulation (rTMS): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm."
117458|NCT01900314|E1|Reported Event|Active rTMS|"20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the FDA-approved device label (10 Hz) to a targeted area of the brain. After these sessions, a second fMRI will be completed then 5 additional tapering treatments of rTMS over a 2 week period.~repetitive Transcranial Magnetic Stimulation (rTMS): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm."
117459|NCT01900249|B4|Baseline|Total|Total of all reporting groups
117460|NCT01900249|B3|Baseline|Placebo|"Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.~Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks."
117461|NCT01900249|B2|Baseline|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5%~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks."
117462|NCT01900249|B1|Baseline|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution, 0.2%~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks."
117463|NCT01900249|P3|Participant Flow|Placebo|"Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.~Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks."
117464|NCT01900249|P2|Participant Flow|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5%~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks."
117465|NCT01900249|P1|Participant Flow|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution, 0.2%~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks."
117466|NCT01900249|O3|Outcome|Placebo|"Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.~Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks."
117469|NCT01900249|E3|Reported Event|Placebo|"Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.~Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks."
117470|NCT01900249|E2|Reported Event|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5%~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks."
117471|NCT01900249|E1|Reported Event|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution, 0.2%~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks."
117472|NCT01900067|B3|Baseline|Total|Total of all reporting groups
117473|NCT01900067|B2|Baseline|Control|no active warming, standard of care
117474|NCT01900067|B1|Baseline|Active Warming|BARRIER® EasyWarm Active Self-Warming Blanket
117475|NCT01900067|P2|Participant Flow|Control|no active warming, standard of care
117476|NCT01900067|P1|Participant Flow|Active Warming|"BARRIER® EasyWarm Active Self-Warming Blanket~BARRIER® EasyWarm Active Self-Warming Blanket"
117477|NCT01900067|O2|Outcome|Control|No active warming, standard of care
117478|NCT01900067|O1|Outcome|Active Warming|BARRIER® EasyWarm Active Self-Warming Blanket
117479|NCT01900067|E2|Reported Event|Control|No active warming, standard of care
117480|NCT01900067|E1|Reported Event|Active Warming|BARRIER® EasyWarm Active Self-Warming Blanket
117481|NCT01900054|B1|Baseline|TAU-284|TAU-284 10mg twice daily for 12 weeks
117482|NCT01900054|P1|Participant Flow|TAU-284|TAU-284 10mg twice daily for 12 weeks
117483|NCT01900054|O1|Outcome|TAU-284|TAU-284 10mg twice daily for 12 weeks
117484|NCT01900054|O1|Outcome|TAU-284|TAU-284 10mg twice daily for 12 weeks
117485|NCT01900054|E1|Reported Event|TAU-284|TAU-284 10mg twice daily for 12 weeks
117486|NCT01899911|B1|Baseline|Vital Signs Patch (VSP)|"Infrared and Red absorbance measurement on chest~VSP: Infrared and red absorbance measurement"
117487|NCT01899911|P1|Participant Flow|Vital Signs Patch (VSP)|"Infrared and Red absorbance measurement on chest~VSP: Infrared and red absorbance measurement"
117488|NCT01899911|O1|Outcome|Vital Signs Patch (VSP)|Infrared and Red absorbance measurement on chest
117489|NCT01899911|E1|Reported Event|Vital Signs Patch (VSP)|"Infrared and Red absorbance measurement on chest~VSP: Infrared and red absorbance measurement"
117490|NCT01899768|B1|Baseline|GSK2339345 1000 µg/Placebo|Participants received two doses of either GSK2339345 1000 µg or matching placebo as a solution administered via an ADI with a four hour dosing interval at 3 visits (one treatment per visit) in Part A and a single dose at 2 visits (one treatment per visit) in Part B and C. Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo or GSK2339345 at each visit period in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit of Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117491|NCT01899768|P1|Participant Flow|GSK2339345 1000 µg|Participants received two doses of either GSK2339345 1000 µg or matching placebo as a solution administered via an ADI with a four hour dosing interval at 3 visits (one treatment per visit) in Part A and a single dose at 2 visits (one treatment per visit) in Part B and C. Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo or GSK2339345 at each visit period in Part B and C, participants received an oral inhalation of 10 microliter (µL) of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit of Part C. The strength of capsaicin solution ranged from 0.49 to 1000 micromolar (µM) and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117492|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117493|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117494|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117704|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
117495|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117496|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117497|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117498|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117499|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117500|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117501|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117502|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117577|NCT01899677|P1|Participant Flow|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
120266|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
117503|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117504|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117505|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117506|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117507|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117508|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117509|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117510|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117578|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
120385|NCT01884545|O4|Outcome|Non-Genetic Risk Counseling|Patients who did not receive genetic risk counseling
117511|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117512|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117513|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117514|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117515|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117516|NCT01899768|O1|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117517|NCT01899768|O1|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117518|NCT01899768|O1|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117579|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
117705|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
117519|NCT01899768|O1|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117520|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117521|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117522|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117523|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117524|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117525|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117526|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117580|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
120386|NCT01884545|O3|Outcome|Genetic Risk Counseling|Patients who received genetic risk counseling
117527|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117528|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117529|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117530|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117531|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117532|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117533|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117534|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117581|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
120387|NCT01884545|O2|Outcome|Non-Health Coaching|Participants who did not receive health coaching
117535|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117536|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117537|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117538|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117539|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117540|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117541|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117542|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117582|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
120388|NCT01884545|O1|Outcome|Health Coaching|Participants who received health coaching
117543|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117544|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117545|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117546|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117547|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117548|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117549|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117550|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117583|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
120389|NCT01884545|O4|Outcome|Non-Genetic Risk Counseling|Patients who did not receive genetic risk counseling
117551|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117552|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117553|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117554|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117555|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117556|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117557|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117558|NCT01899768|O2|Outcome|GSK2339345 1000 Microgram (mcg)|Participants received two doses of GSK2339345 1000 mcg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117584|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
120390|NCT01884545|O3|Outcome|Genetic Risk Counseling|Patients who received genetic risk counseling
117559|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117560|NCT01899768|E2|Reported Event|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117561|NCT01899768|E1|Reported Event|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
117562|NCT01899742|B3|Baseline|Total|Total of all reporting groups
117563|NCT01899742|B2|Baseline|Tiotropium Bromide 18 µg|Participants self-administered one dose of tiotropium bromide 18 µg once daily via a HANDIHALER and placebo once daily via an ELLIPTA dry powder inhaler each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
117564|NCT01899742|B1|Baseline|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose of umeclidinium/vilanterol inhalation powder 62.5/25 µg once daily via an ELLIPTA dry powder inhaler and placebo once daily via a HANDIHALER each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
117565|NCT01899742|P2|Participant Flow|Tiotropium Bromide 18 µg|Participants self-administered one dose of tiotropium bromide 18 µg once daily via a HANDIHALER and placebo once daily via an ELLIPTA dry powder inhaler each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
117566|NCT01899742|P1|Participant Flow|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose of umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg) once daily via an ELLIPTA dry powder inhaler and placebo once daily via a HANDIHALER each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
117567|NCT01899742|O2|Outcome|Tiotropium Bromide 18 µg|Participants self-administered one dose of tiotropium bromide 18 µg once daily via a HANDIHALER and placebo once daily via an ELLIPTA dry powder inhaler each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
117568|NCT01899742|O1|Outcome|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose of umeclidinium/vilanterol inhalation powder 62.5/25 µg once daily via an ELLIPTA dry powder inhaler and placebo once daily via a HANDIHALER each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
117569|NCT01899742|O2|Outcome|Tiotropium Bromide 18 µg|Participants self-administered one dose of tiotropium bromide 18 µg once daily via a HANDIHALER and placebo once daily via an ELLIPTA dry powder inhaler each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
117570|NCT01899742|O1|Outcome|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose of umeclidinium/vilanterol inhalation powder 62.5/25 µg once daily via an ELLIPTA dry powder inhaler and placebo once daily via a HANDIHALER each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
117571|NCT01899742|E2|Reported Event|Tiotropium Bromide 18 µg|Participants self-administered one dose of tiotropium bromide 18 µg once daily via a HANDIHALER and placebo once daily via an ELLIPTA dry powder inhaler each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
117572|NCT01899742|E1|Reported Event|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose of umeclidinium/vilanterol inhalation powder 62.5/25 µg once daily via an ELLIPTA dry powder inhaler and placebo once daily via a HANDIHALER each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
117573|NCT01899677|B3|Baseline|Total|Total of all reporting groups
117574|NCT01899677|B2|Baseline|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
117575|NCT01899677|B1|Baseline|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
117576|NCT01899677|P2|Participant Flow|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
136506|NCT01806857|O2|Outcome|Matching Placebo|
117585|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
117586|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
117587|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
117588|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
117589|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
117590|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
117591|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
117592|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
117593|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
117594|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
117595|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
117596|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
117597|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
117598|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
117599|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
117600|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
117601|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
117602|NCT01899677|E2|Reported Event|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
117603|NCT01899677|E1|Reported Event|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
117604|NCT01899144|B1|Baseline|All Participants|Participants were assigned to 1 of 10 possible treatment sequences for five treatments, separated by 2-7 days. Treatments were single inhalations of Albuterol MDPI 90 mcg, Albuterol MDPI 180 mcg, ProAir HFA MDI 90 mcg, ProAir HFA MDI 180 mcg, and placebo.
117605|NCT01899144|P1|Participant Flow|All Participants|Participants were assigned to 1 of 10 possible treatment sequences for five treatments, separated by 2-7 days. Treatments were single inhalations of Albuterol MDPI 90 mcg, Albuterol MDPI 180 mcg, ProAir HFA MDI 90 mcg, ProAir HFA MDI 180 mcg, and placebo.
117606|NCT01899144|O5|Outcome|Placebo|At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, all devices contain placebo.
117607|NCT01899144|O4|Outcome|ProAir HFA 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the MDIs contain ProAir HFA 90 mcg for a total dose of 180 mcg; the DPIs contained placebo."
117608|NCT01899144|O3|Outcome|ProAir HFA 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the MDIs contains ProAir HFA 90 mcg; the other three devices contained placebo."
117609|NCT01899144|O2|Outcome|Albuterol Spiromax 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the DPIs contain Albuterol Spiromax 90 mcg for a total dose of 180 mcg; the MDIs contained placebo."
117610|NCT01899144|O1|Outcome|Albuterol Spiromax 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the DPIs contains Albuterol Spiromax 90 mcg; the other three devices contained placebo."
117611|NCT01899144|O5|Outcome|Placebo|At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, all devices contain placebo.
117612|NCT01899144|O4|Outcome|ProAir HFA 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the MDIs contain ProAir HFA 90 mcg for a total dose of 180 mcg; the DPIs contained placebo."
120391|NCT01884545|O2|Outcome|Non-Health Coaching|Participants who did not receive health coaching
117613|NCT01899144|O3|Outcome|ProAir HFA 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the MDIs contains ProAir HFA 90 mcg; the other three devices contained placebo."
117614|NCT01899144|O2|Outcome|Albuterol Spiromax 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the DPIs contain Albuterol Spiromax 90 mcg for a total dose of 180 mcg; the MDIs contained placebo."
117615|NCT01899144|O1|Outcome|Albuterol Spiromax 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the DPIs contains Albuterol Spiromax 90 mcg; the other three devices contained placebo."
117616|NCT01899144|O5|Outcome|Placebo|At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, all devices contain placebo.
117617|NCT01899144|O4|Outcome|ProAir HFA 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the MDIs contain ProAir HFA 90 mcg for a total dose of 180 mcg; the DPIs contained placebo."
117618|NCT01899144|O3|Outcome|ProAir HFA 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the MDIs contains ProAir HFA 90 mcg; the other three devices contained placebo."
117619|NCT01899144|O2|Outcome|Albuterol Spiromax 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the DPIs contain Albuterol Spiromax 90 mcg for a total dose of 180 mcg; the MDIs contained placebo."
117620|NCT01899144|O1|Outcome|Albuterol Spiromax 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the DPIs contains Albuterol Spiromax 90 mcg; the other three devices contained placebo."
117621|NCT01899144|E5|Reported Event|Placebo|At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, all devices contain placebo.
117622|NCT01899144|E4|Reported Event|ProAir HFA 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the MDIs contain ProAir HFA 90 mcg for a total dose of 180 mcg; the DPIs contained placebo."
117623|NCT01899144|E3|Reported Event|ProAir HFA 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the MDIs contains ProAir HFA 90 mcg; the other three devices contained placebo."
117624|NCT01899144|E2|Reported Event|Albuterol Spiromax 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the DPIs contain Albuterol Spiromax 90 mcg for a total dose of 180 mcg; the MDIs contained placebo."
117625|NCT01899144|E1|Reported Event|Albuterol Spiromax 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the DPIs contains Albuterol Spiromax 90 mcg; the other three devices contained placebo."
117626|NCT01898884|B6|Baseline|Total|Total of all reporting groups
117627|NCT01898884|B5|Baseline|Single Dose VP 20629 1200 mg|Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
117628|NCT01898884|B4|Baseline|Single Dose VP 20629 900 mg|Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
117629|NCT01898884|B3|Baseline|Single Dose VP 20629 450 mg|Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
117630|NCT01898884|B2|Baseline|Single Dose VP 20629 150 mg|Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
117631|NCT01898884|B1|Baseline|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
117632|NCT01898884|P9|Participant Flow|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117633|NCT01898884|P8|Participant Flow|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117634|NCT01898884|P7|Participant Flow|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117635|NCT01898884|P6|Participant Flow|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
117636|NCT01898884|P5|Participant Flow|Single Dose VP 20629 1200 mg|Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
117637|NCT01898884|P4|Participant Flow|Single Dose VP 20629 900 mg|Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
117638|NCT01898884|P3|Participant Flow|Single Dose VP 20629 450 mg|Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
120392|NCT01884545|O1|Outcome|Health Coaching|Participants who received health coaching
117639|NCT01898884|P2|Participant Flow|Single Dose VP 20629 150 mg|Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
117640|NCT01898884|P1|Participant Flow|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
117641|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117642|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117643|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117644|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117645|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117646|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117647|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117648|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117649|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117650|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117651|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117652|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117653|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117654|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117655|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117656|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117657|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117658|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117659|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117660|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117661|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117662|NCT01898884|O4|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117663|NCT01898884|O3|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117664|NCT01898884|O2|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117665|NCT01898884|O1|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
117666|NCT01898884|O4|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117667|NCT01898884|O3|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117668|NCT01898884|O2|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117669|NCT01898884|O1|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
117670|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117671|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117672|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117673|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117674|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117675|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117676|NCT01898884|O4|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117677|NCT01898884|O3|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117678|NCT01898884|O2|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117679|NCT01898884|O1|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
117680|NCT01898884|O4|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117681|NCT01898884|O3|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117682|NCT01898884|O2|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117683|NCT01898884|O1|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
117684|NCT01898884|O4|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117685|NCT01898884|O3|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117686|NCT01898884|O2|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117687|NCT01898884|O1|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
117688|NCT01898884|O4|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117689|NCT01898884|O3|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117690|NCT01898884|O2|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117691|NCT01898884|O1|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
117692|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
117693|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
117694|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
117695|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
117696|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
117697|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
117698|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
117699|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
117700|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
117701|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
117702|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
117703|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
136507|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
117706|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
117707|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
117708|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
117709|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
117710|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
117711|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
117712|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
117713|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
117714|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
117715|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
117716|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
117717|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
117718|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
117719|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
117720|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
117721|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
117722|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
117723|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
117724|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
117725|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
117726|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
117727|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
117728|NCT01898884|O2|Outcome|Single Dose VP 20629 150mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
117729|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
117730|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
117731|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
117732|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
117733|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
117734|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
117735|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
117736|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
117737|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
117738|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
117739|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
117740|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
117741|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
117742|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
117743|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
117744|NCT01898884|O9|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117745|NCT01898884|O8|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117746|NCT01898884|O7|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117747|NCT01898884|O6|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
117748|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
117749|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
117750|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
117751|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
117752|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
117753|NCT01898884|O9|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117754|NCT01898884|O8|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117755|NCT01898884|O7|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117756|NCT01898884|O6|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
117757|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
117758|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
117759|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
117760|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
117761|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
117762|NCT01898884|O9|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117763|NCT01898884|O8|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117764|NCT01898884|O7|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117765|NCT01898884|O6|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
117766|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
117767|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
117768|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
117769|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
117770|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
117771|NCT01898884|O9|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117772|NCT01898884|O8|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117773|NCT01898884|O7|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117774|NCT01898884|O6|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
117775|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
117776|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
117777|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
117778|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
117779|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
117780|NCT01898884|E9|Reported Event|Multiple Dose VP 20629 900mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117781|NCT01898884|E8|Reported Event|Multiple Dose VP 20629 600mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
117782|NCT01898884|E7|Reported Event|Multiple Dose VP 20629 300mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
120659|NCT01882647|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
117783|NCT01898884|E6|Reported Event|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
117784|NCT01898884|E5|Reported Event|Single Dose VP 20629 1200mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting conditions on Day 1.
117785|NCT01898884|E4|Reported Event|Single Dose VP 20629 900mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting conditions on Day 1.
117786|NCT01898884|E3|Reported Event|Single Dose VP 20629 450mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting conditions on Day 1.
117787|NCT01898884|E2|Reported Event|Single Dose VP 20629 150mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting conditions on Day 1.
117788|NCT01898884|E1|Reported Event|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting conditions on Day 1.
117789|NCT01898598|B3|Baseline|Total|Total of all reporting groups
117790|NCT01898598|B2|Baseline|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
117791|NCT01898598|B1|Baseline|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
117792|NCT01898598|P2|Participant Flow|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
117793|NCT01898598|P1|Participant Flow|Vismodegib|Participants received vismodegib 150 milligrams (mg) capsule orally once daily for 12 weeks.
117794|NCT01898598|O2|Outcome|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
117795|NCT01898598|O1|Outcome|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
117796|NCT01898598|O2|Outcome|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
117797|NCT01898598|O1|Outcome|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
117798|NCT01898598|O2|Outcome|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
117799|NCT01898598|O1|Outcome|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
117800|NCT01898598|O2|Outcome|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
117801|NCT01898598|O1|Outcome|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
117802|NCT01898598|O2|Outcome|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
117803|NCT01898598|O1|Outcome|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
117804|NCT01898598|O2|Outcome|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
117805|NCT01898598|O1|Outcome|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
117806|NCT01898598|E2|Reported Event|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
117807|NCT01898598|E1|Reported Event|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
117808|NCT01898442|B4|Baseline|Total|Total of all reporting groups
117809|NCT01898442|B3|Baseline|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
117810|NCT01898442|B2|Baseline|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
117811|NCT01898442|B1|Baseline|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
117812|NCT01898442|P3|Participant Flow|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
117813|NCT01898442|P2|Participant Flow|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
117814|NCT01898442|P1|Participant Flow|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
117815|NCT01898442|O3|Outcome|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
117816|NCT01898442|O2|Outcome|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
117817|NCT01898442|O1|Outcome|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
117818|NCT01898442|O3|Outcome|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
117819|NCT01898442|O2|Outcome|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
117820|NCT01898442|O1|Outcome|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
117821|NCT01898442|O3|Outcome|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
117822|NCT01898442|O2|Outcome|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
117823|NCT01898442|O1|Outcome|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
117824|NCT01898442|O3|Outcome|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
117825|NCT01898442|O2|Outcome|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
117826|NCT01898442|O1|Outcome|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
117827|NCT01898442|O3|Outcome|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
117828|NCT01898442|O2|Outcome|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
117829|NCT01898442|O1|Outcome|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
117830|NCT01898442|O3|Outcome|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
117831|NCT01898442|O2|Outcome|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
117832|NCT01898442|O1|Outcome|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
117833|NCT01898442|E3|Reported Event|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
117834|NCT01898442|E2|Reported Event|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
117835|NCT01898442|E1|Reported Event|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
117836|NCT01898403|B1|Baseline|Sentinel Lymph Node (SLN) Detection|"All patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.~Indocyanine green solution: Administered peri-tumoral and intradermally~Isosulfan blue (ISB): Administered peri-tumoral and intradermally~Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)"
117837|NCT01898403|P1|Participant Flow|Sentinel Lymph Node (SLN) Detection|"All patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.~Indocyanine green solution: Administered peri-tumoral and intradermally~Isosulfan blue (ISB): Administered peri-tumoral and intradermally~Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)"
117838|NCT01898403|O3|Outcome|Sentinel Lymph Node (SLN) Detection by TSC Lymphoscintigraphy|All patients received peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.
117839|NCT01898403|O2|Outcome|Sentinel Lymph Node (SLN) Detection by Indocyanine Green|All patients received peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.
117840|NCT01898403|O1|Outcome|Sentinel Lymph Node (SLN) Detection by Isosulfan Blue|All patients received peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.
117841|NCT01898403|E1|Reported Event|Sentinel Lymph Node (SLN) Detection|"All patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.~Indocyanine green solution: Administered peri-tumoral and intradermally~Isosulfan blue (ISB): Administered peri-tumoral and intradermally~Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)"
117842|NCT01898286|B1|Baseline|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
117843|NCT01898286|P1|Participant Flow|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
117844|NCT01898286|O1|Outcome|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
117845|NCT01898286|O1|Outcome|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
117846|NCT01898286|O1|Outcome|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
117847|NCT01898286|O1|Outcome|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
117848|NCT01898286|E1|Reported Event|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
117849|NCT01898208|B4|Baseline|Total|Total of all reporting groups
117850|NCT01898208|B3|Baseline|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
117851|NCT01898208|B2|Baseline|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
117852|NCT01898208|B1|Baseline|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
117853|NCT01898208|P3|Participant Flow|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
117854|NCT01898208|P2|Participant Flow|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture Infectious Disease (ID) Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
117855|NCT01898208|P1|Participant Flow|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
120660|NCT01882647|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
117856|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
117857|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
117858|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
117859|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
117860|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
117861|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
117862|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
117863|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
117864|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
117865|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
117866|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
117867|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
117868|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
117869|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
117870|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
117871|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
117872|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
117873|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
117874|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
117875|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
117876|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
117877|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
117878|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
117879|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
117880|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
117881|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
120393|NCT01884545|O4|Outcome|Non-Genetic Risk Counseling|Patients who did not receive genetic risk counseling
117882|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
117883|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
117884|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
117885|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
117886|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
117887|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
117888|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
117889|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
117890|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
117891|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
117892|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
117893|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
117894|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
117895|NCT01898208|E3|Reported Event|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
117896|NCT01898208|E2|Reported Event|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
117897|NCT01898208|E1|Reported Event|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
117898|NCT01898195|B4|Baseline|Total|Total of all reporting groups
117899|NCT01898195|B3|Baseline|Standard Care + Text Message + ABT|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts and seven phone developed Adherence Behavioral Therapy sessions~Varenicline: Varenicline will be provided for three months.~Text Message: Text messages will be developed twice daily for three months~Adherence Behavioral Therapy: Seven Adherence Behavioral Therapy sessions will given over a three month period"
117900|NCT01898195|B2|Baseline|Standard Care + Text Message|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts.~Varenicline: Varenicline will be provided for three months.~Text Message: Text messages will be developed twice daily for three months"
117901|NCT01898195|B1|Baseline|Standard Care|"Participants in this arm will receive varenicline for smoking cessation.~Varenicline: Varenicline will be provided for three months."
117902|NCT01898195|P3|Participant Flow|Standard Care + Text Message + ABT|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts and seven phone developed Adherence Behavioral Therapy sessions~Varenicline: Varenicline will be provided for three months.~Text Message: Text messages will be developed twice daily for three months~Adherence Behavioral Therapy: Seven Adherence Behavioral Therapy sessions will given over a three month period"
117903|NCT01898195|P2|Participant Flow|Standard Care + Text Message|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts.~Varenicline: Varenicline will be provided for three months.~Text Message: Text messages will be developed twice daily for three months"
117904|NCT01898195|P1|Participant Flow|Standard Care|"Participants in this arm will receive varenicline for smoking cessation.~Varenicline: Varenicline will be provided for three months."
117905|NCT01898195|O3|Outcome|Standard Care + Text Message + ABT|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts and seven phone developed Adherence Behavioral Therapy sessions~Varenicline: Varenicline will be provided for three months.~Text Message: Text messages will be developed twice daily for three months~Adherence Behavioral Therapy: Seven Adherence Behavioral Therapy sessions will given over a three month period"
117906|NCT01898195|O2|Outcome|Standard Care + Text Message|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts.~Varenicline: Varenicline will be provided for three months.~Text Message: Text messages will be developed twice daily for three months"
117907|NCT01898195|O1|Outcome|Standard Care|"Participants in this arm will receive varenicline for smoking cessation.~Varenicline: Varenicline will be provided for three months."
120394|NCT01884545|O3|Outcome|Genetic Risk Counseling|Patients who received genetic risk counseling
117908|NCT01898195|O3|Outcome|Standard Care + Text Message + ABT|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts and seven phone developed Adherence Behavioral Therapy sessions~Varenicline: Varenicline will be provided for three months.~Text Message: Text messages will be developed twice daily for three months~Adherence Behavioral Therapy: Seven Adherence Behavioral Therapy sessions will given over a three month period"
117909|NCT01898195|O2|Outcome|Standard Care + Text Message|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts.~Varenicline: Varenicline will be provided for three months.~Text Message: Text messages will be developed twice daily for three months"
117910|NCT01898195|O1|Outcome|Standard Care|"Participants in this arm will receive varenicline for smoking cessation.~Varenicline: Varenicline will be provided for three months."
117911|NCT01898195|E3|Reported Event|Standard Care + Text Message + ABT|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts and seven phone developed Adherence Behavioral Therapy sessions~Varenicline: Varenicline will be provided for three months.~Text Message: Text messages will be developed twice daily for three months~Adherence Behavioral Therapy: Seven Adherence Behavioral Therapy sessions will given over a three month period"
117912|NCT01898195|E2|Reported Event|Standard Care + Text Message|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts.~Varenicline: Varenicline will be provided for three months.~Text Message: Text messages will be developed twice daily for three months"
117913|NCT01898195|E1|Reported Event|Standard Care|"Participants in this arm will receive varenicline for smoking cessation.~Varenicline: Varenicline will be provided for three months."
117914|NCT01898091|B3|Baseline|Total|Total of all reporting groups
117915|NCT01898091|B2|Baseline|Placebo Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.~Placebo Mouthrinse: 10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy."
117916|NCT01898091|B1|Baseline|Neem Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.~Neem Mouthrinse: 10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy."
117917|NCT01898091|P2|Participant Flow|Placebo Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.~Placebo Mouthrinse: 10ml dose of assigned study mouthrinse [mouthrinse base], three times per day, for approximately 7 weeks during radiation therapy."
117918|NCT01898091|P1|Participant Flow|Neem Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.~Neem Mouthrinse: 10ml dose of assigned study mouthrinse [mouthrinse base plus 1% solution by weight of neem supercritical extract], three times per day, for approximately 7 weeks during radiation therapy."
117919|NCT01898091|O2|Outcome|Placebo Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.~Placebo Mouthrinse: 10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy."
117920|NCT01898091|O1|Outcome|Neem Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.~Neem Mouthrinse: 10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy."
117921|NCT01898091|E2|Reported Event|Placebo Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.~Placebo Mouthrinse: 10ml dose of assigned study mouthrinse [mouthrinse base], three times per day, for approximately 7 weeks during radiation therapy."
117922|NCT01898091|E1|Reported Event|Neem Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.~Neem Mouthrinse: 10ml dose of assigned study mouthrinse [mouthrinse base plus 1% solution by weight of neem supercritical extract], three times per day, for approximately 7 weeks during radiation therapy."
117923|NCT01897792|B3|Baseline|Total|Total of all reporting groups
117924|NCT01897792|B2|Baseline|0.9% Saline and Sugar Pill|"100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.~Saline (for Vitamin C): 0.9% saline administered to mimic Vitamin C~Placebo (for Vitamin E): Sugar pill administered to mimic Vitamin E"
117925|NCT01897792|B1|Baseline|Vitamins C and E|"Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.~Vitamin C~Vitamin E"
117926|NCT01897792|P2|Participant Flow|0.9% Saline and Sugar Pill|"100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.~Saline (for Vitamin C): 0.9% saline administered to mimic Vitamin C~Placebo (for Vitamin E): Sugar pill administered to mimic Vitamin E"
117927|NCT01897792|P1|Participant Flow|Vitamins C and E|"Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.~Vitamin C~Vitamin E"
117928|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
117929|NCT01897792|O1|Outcome|Vitamins C and E|Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
120395|NCT01884545|O2|Outcome|Non-Health Coaching|Participants who did not receive health coaching
117930|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
117931|NCT01897792|O1|Outcome|Vitamins C and E|Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
117932|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
117933|NCT01897792|O1|Outcome|Vitamins C and E|Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
117934|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
117935|NCT01897792|O1|Outcome|Vitamins C and E|Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
117936|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
117937|NCT01897792|O1|Outcome|Vitamins C and E|Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
117938|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill Participants - Protocol Violations|# of protocol deviations
117939|NCT01897792|O1|Outcome|Vitamin C and E Participants -|# of protocol deviations
117940|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
117941|NCT01897792|O1|Outcome|Vitamins C and E|Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
117942|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
117943|NCT01897792|O1|Outcome|Vitamins C and E|Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
117944|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
117945|NCT01897792|O1|Outcome|Vitamins C and E|Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
117946|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|"100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.~Saline (for Vitamin C): 0.9% saline administered to mimic Vitamin C~Placebo (for Vitamin E): Sugar pill administered to mimic Vitamin E"
117947|NCT01897792|O1|Outcome|Vitamins C and E|"Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.~Vitamin C~Vitamin E"
117948|NCT01897792|E2|Reported Event|0.9% Saline and Sugar Pill|"100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.~Saline (for Vitamin C): 0.9% saline administered to mimic Vitamin C~Placebo (for Vitamin E): Sugar pill administered to mimic Vitamin E"
117949|NCT01897792|E1|Reported Event|Vitamins C and E|"Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.~Vitamin C~Vitamin E"
117950|NCT01897727|B3|Baseline|Total|Total of all reporting groups
117951|NCT01897727|B2|Baseline|Standard of Care BP Treatment|Antihypertensive medication added and/or uptitrated to keep BP < 140/90 mm Hg throughout the study.
117952|NCT01897727|B1|Baseline|Spironolactone|Spironolactone 25 mg administered following baseline measurements and uptitrated to 50 mg if BP > 140/90 mm Hg throughout the 3 month study.
117953|NCT01897727|P2|Participant Flow|Standard of Care BP Treatment|Antihypertensive medication added and/or uptitrated to keep BP < 140/90 mm Hg throughout the study.
117954|NCT01897727|P1|Participant Flow|Spironolactone|Spironolactone 25 mg administered following baseline measurements and uptitrated to 50 mg if BP > 140/90 mm Hg throughout the 3 month study.
117955|NCT01897727|O2|Outcome|Standard of Care BP Treatment|Antihypertensive medication added and/or uptitrated to keep BP < 140/90 mm Hg throughout the study.
117956|NCT01897727|O1|Outcome|Spironolactone|Spironolactone 25 mg administered following baseline measurements and uptitrated to 50 mg if BP > 140/90 mm Hg throughout the 3 month study.
117957|NCT01897727|E2|Reported Event|Standard of Care BP Treatment|Antihypertensive medication added and/or uptitrated to keep BP < 140/90 mm Hg throughout the study.
117958|NCT01897727|E1|Reported Event|Spironolactone|Spironolactone 25 mg administered following baseline measurements and uptitrated to 50 mg if BP > 140/90 mm Hg throughout the 3 month study.
117959|NCT01897402|B3|Baseline|Total|Total of all reporting groups
117960|NCT01897402|B2|Baseline|US Licensed Vaccine|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
117961|NCT01897402|B1|Baseline|Test Vaccine|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
117962|NCT01897402|P2|Participant Flow|US Licensed Vaccine|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
117963|NCT01897402|P1|Participant Flow|Test Vaccine|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
117964|NCT01897402|O2|Outcome|US Licensed Vaccine|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
117965|NCT01897402|O1|Outcome|Test Vaccine|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
117966|NCT01897402|O4|Outcome|US Licensed Vaccine - Female|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
117967|NCT01897402|O3|Outcome|US Licensed Vaccine - Male|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
117968|NCT01897402|O2|Outcome|Test Vaccine - Female|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
117969|NCT01897402|O1|Outcome|Test Vaccine - Male|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
117970|NCT01897402|O2|Outcome|US Licensed Vaccine|"Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine~US Licensed Vaccine: Meningococcal (Groups A,C,Y,W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine 0.5 mL dose, intramuscular. Single dose contains 4 µg each Serogroup A, C, W-135 and Y conjugated to approximately 48 µg total diphtheria toxoid."
117971|NCT01897402|O1|Outcome|Test Vaccine|"NmVac4-A/C/Y/W-135-DT™ conjugate vaccine~Test Vaccine: NmVac4-A/C/Y/W-135-DT™ conjugate is a vaccine in liquid form composed of purified polysaccharides (PS) conjugated to diphtheria toxoid. Single intramuscular 0.5 mL dose contains 4 µg each of Serogroup A, C, W-135, and Y PS conjugated to approximately 26 µg total diphtheria toxoid."
117972|NCT01897402|E2|Reported Event|US Licensed Vaccine|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
117973|NCT01897402|E1|Reported Event|Test Vaccine|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
117974|NCT01897285|B1|Baseline|All Participants: AQUACEL® Foam Adhesive Dressings|"Original adhesive + test adhesive~AQUACEL® foam adhesive dressings"
117975|NCT01897285|P1|Participant Flow|All Study Participants|"Original adhesive and Test adhesive on right and left upper arm and right and left lower back.~AQUACEL® foam adhesive dressing Original Adhesive: Arm, Test Adhesive: Arm, Original Adhesive: Back, Test Adhesive: Back"
117976|NCT01897285|O2|Outcome|AQUACEL® Foam Adhesive Dressing - Test Adhesive|"Test adhesive~AQUACEL® foam adhesive dressing"
117977|NCT01897285|O1|Outcome|AQUACEL® Foam Adhesive Dressing - Original Adhesive|"Original adhesive~AQUACEL® foam adhesive dressing"
117978|NCT01897285|O2|Outcome|AQUACEL® Foam Adhesive Dressing - Test Adhesive|"Test adhesive~AQUACEL® foam adhesive dressing"
117979|NCT01897285|O1|Outcome|AQUACEL® Foam Adhesive Dressing - Original Adhesive|"Original adhesive~AQUACEL® foam adhesive dressing"
117980|NCT01897285|E2|Reported Event|AQUACEL® Foam Adhesive Dressing - Test Adhesive|"Test adhesive~AQUACEL® foam adhesive dressing"
117981|NCT01897285|E1|Reported Event|AQUACEL® Foam Adhesive Dressing - Original Adhesive|"Original adhesive~AQUACEL® foam adhesive dressing"
117982|NCT01897233|B1|Baseline|Lumacaftor/Ivacaftor (LUM/IVA)|"Part A Cohort 1: Participants aged 6 through 8 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.~Part A Cohort 2: Participants aged 9 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.~Part B: Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks."
117983|NCT01897233|P1|Participant Flow|Lumacaftor/Ivacaftor (LUM/IVA)|"Part A Cohort 1: Participants aged 6 through 8 years received LUM 200 milligram (mg) in fixed-dose combination with IVA 250 mg orally every 12 hours (q12h) for 14 days.~Part A Cohort 2: Participants aged 9 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.~Part B: Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks."
117984|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
117985|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
117986|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
117987|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
117988|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
117989|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
117990|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
117991|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
117992|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks
117993|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
117994|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
117995|NCT01897233|O1|Outcome|Part A Overall Arm: LUM/IVA|All participants aged 6 through 11 years who received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
136508|NCT01806857|O2|Outcome|Matching Placebo|
117996|NCT01897233|O1|Outcome|Part A Overall Arm: LUM/IVA|All participants aged 6 through 11 years who received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
117997|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
117998|NCT01897233|O1|Outcome|Part A Overall Arm: LUM/IVA|All participants aged 6 through 11 years who received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
117999|NCT01897233|O1|Outcome|Part A Overall Arm: LUM/IVA|All participants aged 6 through 11 years who received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
118000|NCT01897233|O1|Outcome|Part A Overall Arm: LUM/IVA|All participants aged 6 through 11 years who received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
118001|NCT01897233|E3|Reported Event|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
118002|NCT01897233|E2|Reported Event|Part A Cohort 2: LUM/IVA|Participants aged 9 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
118003|NCT01897233|E1|Reported Event|Part A Cohort 1: LUM/IVA|Participants aged 6 through 8 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
118004|NCT01897025|B3|Baseline|Total|Total of all reporting groups
118005|NCT01897025|B2|Baseline|Sham-tDCS With MI-BCI|"10 sessions of sham tDCS with BCI motor training, each session of which will be conducted as follows:~The same electrode placement and stimulation parameters will be employed for sham tDCS as for real tDCS. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation. This method of sham stimulation has also been validated (Gandiga et al., 2006). Current intensity will be increased and decreased gradually to decrease perception.~MI-BCI training will be the same as the real-tDCS group and will similarly last for 40 minutes.~real-tDCS with MI-BCI: As in Arm Description"
118006|NCT01897025|B1|Baseline|Real-tDCS With MI-BCI|"10 sessions of the following: 20 minutes of tDCS prior to each session of motor training with the MI-BCI system.~Direct current at an intensity of 1mA with anode placed over the M1 motor cortex of the affected hemisphere and the cathode placed over the unaffected M1.~After initial calibration, MI-BCI training will involve motor imagery of reaching tasks using the clock game interface of the MIT-Manus robotic system to perform multi-directional reaching movements. Upon detection of the intention to move towards the target on BCI, the robotic arm will complete the reaching movement towards the target. Each training session will last for 40 minutes excluding set-up time.~real-tDCS with MI-BCI: As in Arm Description"
118007|NCT01897025|P2|Participant Flow|Sham-tDCS With MI-BCI|"10 sessions of sham tDCS with BCI motor training, each session of which will be conducted as follows:~The same electrode placement and stimulation parameters will be employed for sham tDCS as for real tDCS. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation. This method of sham stimulation has also been validated (Gandiga et al., 2006). Current intensity will be increased and decreased gradually to decrease perception.~MI-BCI training will be the same as the real-tDCS group and will similarly last for 40 minutes.~real-tDCS with MI-BCI: As in Arm Description"
118008|NCT01897025|P1|Participant Flow|Real-tDCS With MI-BCI|"10 sessions of the following: 20 minutes of tDCS prior to each session of motor training with the MI-BCI system.~Direct current at an intensity of 1mA with anode placed over the M1 motor cortex of the affected hemisphere and the cathode placed over the unaffected M1.~After initial calibration, MI-BCI training will involve motor imagery of reaching tasks using the clock game interface of the MIT-Manus robotic system to perform multi-directional reaching movements. Upon detection of the intention to move towards the target on BCI, the robotic arm will complete the reaching movement towards the target. Each training session will last for 40 minutes excluding set-up time.~real-tDCS with MI-BCI: As in Arm Description"
118009|NCT01897025|O2|Outcome|Sham-tDCS With MI-BCI|"10 sessions of sham tDCS with BCI motor training, each session of which will be conducted as follows:~The same electrode placement and stimulation parameters will be employed for sham tDCS as for real tDCS. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation. This method of sham stimulation has also been validated (Gandiga et al., 2006). Current intensity will be increased and decreased gradually to decrease perception.~MI-BCI training will be the same as the real-tDCS group and will similarly last for 40 minutes.~real-tDCS with MI-BCI: As in Arm Description"
118010|NCT01897025|O1|Outcome|Real-tDCS With MI-BCI|"10 sessions of the following: 20 minutes of tDCS prior to each session of motor training with the MI-BCI system.~Direct current at an intensity of 1mA with anode placed over the M1 motor cortex of the affected hemisphere and the cathode placed over the unaffected M1.~After initial calibration, MI-BCI training will involve motor imagery of reaching tasks using the clock game interface of the MIT-Manus robotic system to perform multi-directional reaching movements. Upon detection of the intention to move towards the target on BCI, the robotic arm will complete the reaching movement towards the target. Each training session will last for 40 minutes excluding set-up time.~real-tDCS with MI-BCI: As in Arm Description"
118011|NCT01897025|E2|Reported Event|Sham-tDCS With MI-BCI|"10 sessions of sham tDCS with BCI motor training, each session of which will be conducted as follows:~The same electrode placement and stimulation parameters will be employed for sham tDCS as for real tDCS. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation. This method of sham stimulation has also been validated (Gandiga et al., 2006). Current intensity will be increased and decreased gradually to decrease perception.~MI-BCI training will be the same as the real-tDCS group and will similarly last for 40 minutes.~real-tDCS with MI-BCI: As in Arm Description"
118012|NCT01897025|E1|Reported Event|Real-tDCS With MI-BCI|"10 sessions of the following: 20 minutes of tDCS prior to each session of motor training with the MI-BCI system.~Direct current at an intensity of 1mA with anode placed over the M1 motor cortex of the affected hemisphere and the cathode placed over the unaffected M1.~After initial calibration, MI-BCI training will involve motor imagery of reaching tasks using the clock game interface of the MIT-Manus robotic system to perform multi-directional reaching movements. Upon detection of the intention to move towards the target on BCI, the robotic arm will complete the reaching movement towards the target. Each training session will last for 40 minutes excluding set-up time.~real-tDCS with MI-BCI: As in Arm Description"
118013|NCT01896986|B3|Baseline|Total|Total of all reporting groups
120396|NCT01884545|O1|Outcome|Health Coaching|Participants who received health coaching
118014|NCT01896986|B2|Baseline|IBD Patients|"Children/adolescent females 12-26 years diagnosed with IBD.~Subgroups:~3. receiving immunosuppressant therapy 4. not on immunosuppressant therapy"
118015|NCT01896986|B1|Baseline|PRD Patrients|"Children/adolescent females 12-26 years with a PRD such as JIA (Juvenile Idiopathic Arthritis) or SLE (Systemic Lupus Erythematosus)~Subgroups:~receiving immunosuppressant therapy~not on immunosuppressant therapy"
118016|NCT01896986|P2|Participant Flow|IBD Patients|"Children/adolescent females 12-26 years diagnosed with IBD.~Subgroups:~3. receiving immunosuppressant therapy 4. not on immunosuppressant therapy"
118017|NCT01896986|P1|Participant Flow|PRD Patrients|"Children/adolescent females 12-26 years with a PRD such as JIA (Juvenile Idiopathic Arthritis) or SLE (Systemic Lupus Erythematosus)~Subgroups:~receiving immunosuppressant therapy~not on immunosuppressant therapy"
118018|NCT01896986|O2|Outcome|IBD Patients|"Children/adolescent females 12-26 years diagnosed with IBD.~Subgroups:~3. receiving immunosuppressant therapy 4. not on immunosuppressant therapy~No samples analysed."
118019|NCT01896986|O1|Outcome|PRD Patrients|"Children/adolescent females 12-26 years with a PRD such as JIA (Juvenile Idiopathic Arthritis) or SLE (Systemic Lupus Erythematosus)~Subgroups:~receiving immunosuppressant therapy~not on immunosuppressant therapy~No samples analysed."
118020|NCT01896986|E2|Reported Event|IBD Patients|"Children/adolescent females 12-26 years diagnosed with IBD.~Subgroups:~3. receiving immunosuppressant therapy 4. not on immunosuppressant therapy~no adverse events"
118021|NCT01896986|E1|Reported Event|PRD Patrients|"Children/adolescent females 12-26 years with a PRD such as JIA (Juvenile Idiopathic Arthritis) or SLE (Systemic Lupus Erythematosus)~Subgroups:~receiving immunosuppressant therapy~not on immunosuppressant therapy~no adverse events"
118022|NCT01896934|B1|Baseline|Sertraline|50-200mg daily
118023|NCT01896934|P1|Participant Flow|Sertraline|"50-200mg daily~Sertraline: 50-200mg daily"
118024|NCT01896934|O1|Outcome|Sertraline|"50-200mg daily~Sertraline: 50-200mg daily"
118025|NCT01896934|O1|Outcome|Sertraline|"50-200mg daily~Sertraline: 50-200mg daily"
118026|NCT01896934|O1|Outcome|Sertraline|"50-200mg daily~Sertraline: 50-200mg daily"
118027|NCT01896934|E1|Reported Event|Sertraline|50-200mg daily
118028|NCT01896895|B4|Baseline|Total|Total of all reporting groups
118029|NCT01896895|B3|Baseline|Double-blind MP: IncobotulinumtoxinA 50 Units|Participants received 1.0 mL of incobotulinumtoxinA containing 50 units per injection session (25 units per eye) via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
118030|NCT01896895|B2|Baseline|Double-blind MP: IncobotulinumtoxinA 25 Units|Participants received 1.0 mL of incobotulinumtoxinA containing 25 units per injection session (12.5 units per eye) via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
118031|NCT01896895|B1|Baseline|Double-blind MP: Placebo|Participants received 1.0 mL placebo matched to the volume of incobotulinumtoxinA doses per injection session via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
118032|NCT01896895|P4|Participant Flow|OLEX: IncobotulinumtoxinA 70 Units|Participants received up to 1.4 mL of incobotulinumtoxinA containing up to 70 units per injection session (35 units per eye) via intramuscular injections into orbicular oculi muscles on Day 1 in the OLEX Period.
118033|NCT01896895|P3|Participant Flow|Double-blind MP: IncobotulinumtoxinA 50 Units|Participants received 1.0 mL of incobotulinumtoxinA containing 50 units per injection session (25 units per eye) via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
118034|NCT01896895|P2|Participant Flow|Double-blind MP: IncobotulinumtoxinA 25 Units|Participants received 1.0 mL of incobotulinumtoxinA containing 25 units per injection session (12.5 units per eye) via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
118035|NCT01896895|P1|Participant Flow|Double-blind MP: Placebo|Participants received 1.0 milliliter (mL) placebo matched to the volume of incobotulinumtoxinA doses per injection session via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
118036|NCT01896895|O3|Outcome|Double-blind MP: IncobotulinumtoxinA 50 Units|Participants received 1.0 mL of incobotulinumtoxinA containing 50 units per injection session (25 units per eye) via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
118037|NCT01896895|O2|Outcome|Double-blind MP: IncobotulinumtoxinA 25 Units|Participants received 1.0 mL of incobotulinumtoxinA containing 25 units per injection session (12.5 units per eye) via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
118038|NCT01896895|O1|Outcome|Double-blind MP: Placebo|Participants received 1.0 mL placebo matched to the volume of incobotulinumtoxinA doses per injection session via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
118039|NCT01896895|O3|Outcome|Double-blind MP: IncobotulinumtoxinA 50 Units|Participants received 1.0 mL of incobotulinumtoxinA containing 50 units per injection session (25 units per eye) via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
118040|NCT01896895|O2|Outcome|Double-blind MP: IncobotulinumtoxinA 25 Units|Participants received 1.0 mL of incobotulinumtoxinA containing 25 units per injection session (12.5 units per eye) via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
118041|NCT01896895|O1|Outcome|Double-blind MP: Placebo|Participants received 1.0 mL placebo matched to the volume of incobotulinumtoxinA doses per injection session via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
118042|NCT01896895|O3|Outcome|Double-blind MP: IncobotulinumtoxinA 50 Units|Participants received 1.0 mL of incobotulinumtoxinA containing 50 units per injection session (25 units per eye) via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
118043|NCT01896895|O2|Outcome|Double-blind MP: IncobotulinumtoxinA 25 Units|Participants received 1.0 mL of incobotulinumtoxinA containing 25 units per injection session (12.5 units per eye) via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
118044|NCT01896895|O1|Outcome|Double-blind MP: Placebo|Participants received 1.0 mL placebo matched to the volume of incobotulinumtoxinA doses per injection session via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
118045|NCT01896895|E4|Reported Event|OLEX: IncobotulinumtoxinA 70 Units|Participants received up to 1.4 mL of incobotulinumtoxinA containing up to 70 units per injection session (35 units per eye) via intramuscular injections into orbicular oculi muscles on Day 1 in the OLEX Period.
118046|NCT01896895|E3|Reported Event|Double-blind MP: IncobotulinumtoxinA 50 Units|Participants received 1.0 mL of incobotulinumtoxinA containing 50 units per injection session (25 units per eye) via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
118047|NCT01896895|E2|Reported Event|Double-blind MP: IncobotulinumtoxinA 25 Units|Participants received 1.0 mL of incobotulinumtoxinA containing 25 units per injection session (12.5 units per eye) via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
118048|NCT01896895|E1|Reported Event|Double-blind MP: Placebo|Participants received 1.0 mL placebo matched to the volume of incobotulinumtoxinA doses per injection session via intramuscular injections into orbicular oculi muscles on Day 1 in the double-blind MP.
118049|NCT01896726|B1|Baseline|Baricitinib + Microgynon|Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Days 1 and 29. 10 mg baricitinib tablet administered orally, QD, on Days 23 through 30.
118050|NCT01896726|P1|Participant Flow|Baricitinib + Microgynon|Microgynon tablet [30 micrograms (µg) ethinyl estradiol and 150 µg levonorgestrel] administered orally, once daily (QD), on Days 1 and 29. 10 milligrams (mg) baricitinib tablet administered orally, QD, on Days 23 through 30.
118051|NCT01896726|O2|Outcome|Baricitinib + Microgynon|10 mg baricitinib tablet administered orally, QD, on Days 23 through 30 with coadministration of Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 29.
118052|NCT01896726|O1|Outcome|Microgynon Alone|Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 1
118053|NCT01896726|O2|Outcome|Baricitinib + Microgynon|10 mg baricitinib tablet administered orally, QD, on Days 23 through 30 with coadministration of Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 29.
118054|NCT01896726|O1|Outcome|Microgynon Alone|Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 1
118055|NCT01896726|O2|Outcome|Baricitinib + Microgynon|10 mg baricitinib tablet administered orally, QD, on Days 23 through 30 with coadministration of Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 29.
118056|NCT01896726|O1|Outcome|Microgynon Alone|Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 1
118057|NCT01896726|O2|Outcome|Baricitinib + Microgynon|10 mg baricitinib tablet administered orally, QD, on Days 23 through 30 with coadministration of Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 29.
118058|NCT01896726|O1|Outcome|Microgynon Alone|Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 1
118059|NCT01896726|E3|Reported Event|Baricitinib + Microgynon|"10 mg baricitinib tablet administered orally, QD, on Days 29 through 30 with coadministration of Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 29.~Adverse events are reported from postdose on Day 29 up to Day 40."
118060|NCT01896726|E2|Reported Event|Baricitinib|"10 mg baricitinib tablet administered orally, QD, on Days 23 through 28.~Adverse events are reported from postdose on Day 23 through predose on Day 29."
118061|NCT01896726|E1|Reported Event|Microgynon Alone|"Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 1.~Adverse events are reported from baseline through predose on Day 23."
118062|NCT01896700|B3|Baseline|Total|Total of all reporting groups
118063|NCT01896700|B2|Baseline|Placebo|"Placebo pill, bid for 6 weeks~Placebo: Escalating matched dose of placebo"
118064|NCT01896700|B1|Baseline|Methylphenidate|"Intervention: An escalating dose of methylphenidate taken by mouth: 20mg for 2 weeks, 40mg for 2 weeks, 60mg for 2 weeks. All doses divided twice/day.~Other name: Ritalin~Methylphenidate: Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each"
118065|NCT01896700|P2|Participant Flow|Placebo|"Placebo pill, bid for 6 weeks~Placebo: Escalating matched dose of placebo"
118066|NCT01896700|P1|Participant Flow|Methylphenidate|"Intervention: An escalating dose of methylphenidate taken by mouth: 20mg for 2 weeks, 40mg for 2 weeks, 60mg for 2 weeks. All doses divided twice/day.~Other name: Ritalin~Methylphenidate: Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each"
118067|NCT01896700|O2|Outcome|Placebo|"Placebo pill, bid for 6 weeks~Placebo: Escalating matched dose of placebo"
118068|NCT01896700|O1|Outcome|Methylphenidate|"Intervention: An escalating dose of methylphenidate taken by mouth: 20mg for 2 weeks, 40mg for 2 weeks, 60mg for 2 weeks. All doses divided twice/day.~Other name: Ritalin~Methylphenidate: Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each"
118069|NCT01896700|O2|Outcome|Placebo|"Placebo pill, bid for 6 weeks~Placebo: Escalating matched dose of placebo"
118070|NCT01896700|O1|Outcome|Methylphenidate|"Intervention: An escalating dose of methylphenidate taken by mouth: 20mg for 2 weeks, 40mg for 2 weeks, 60mg for 2 weeks. All doses divided twice/day.~Other name: Ritalin~Methylphenidate: Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each"
118071|NCT01896700|O2|Outcome|Placebo|"Placebo pill, bid for 6 weeks~Placebo: Escalating matched dose of placebo"
118072|NCT01896700|O1|Outcome|Methylphenidate|"Intervention: An escalating dose of methylphenidate taken by mouth: 20mg for 2 weeks, 40mg for 2 weeks, 60mg for 2 weeks. All doses divided twice/day.~Other name: Ritalin~Methylphenidate: Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each"
118073|NCT01896700|O2|Outcome|Placebo|"Placebo pill, bid for 6 weeks~Placebo: Escalating matched dose of placebo"
118074|NCT01896700|O1|Outcome|Methylphenidate|"Intervention: An escalating dose of methylphenidate taken by mouth: 20mg for 2 weeks, 40mg for 2 weeks, 60mg for 2 weeks. All doses divided twice/day.~Other name: Ritalin~Methylphenidate: Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each"
118075|NCT01896700|O2|Outcome|Placebo|"Placebo pill, bid for 6 weeks~Placebo: Escalating matched dose of placebo"
118076|NCT01896700|O1|Outcome|Methylphenidate|"Intervention: An escalating dose of methylphenidate taken by mouth: 20mg for 2 weeks, 40mg for 2 weeks, 60mg for 2 weeks. All doses divided twice/day.~Other name: Ritalin~Methylphenidate: Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each"
118077|NCT01896700|O2|Outcome|Placebo|"Placebo pill, bid for 6 weeks~Placebo: Escalating matched dose of placebo"
118117|NCT01896544|O1|Outcome|Placebo|"Oral suspension of placebo cholecalciferol~Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
118078|NCT01896700|O1|Outcome|Methylphenidate|"Intervention: An escalating dose of methylphenidate taken by mouth: 20mg for 2 weeks, 40mg for 2 weeks, 60mg for 2 weeks. All doses divided twice/day.~Other name: Ritalin~Methylphenidate: Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each"
118079|NCT01896700|O2|Outcome|Placebo|"Placebo pill, bid for 6 weeks~Placebo: Escalating matched dose of placebo"
118080|NCT01896700|O1|Outcome|Methylphenidate|"Intervention: An escalating dose of methylphenidate taken by mouth: 20mg for 2 weeks, 40mg for 2 weeks, 60mg for 2 weeks. All doses divided twice/day.~Other name: Ritalin~Methylphenidate: Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each"
118081|NCT01896700|O2|Outcome|Placebo|"Placebo pill, bid for 6 weeks~Placebo: Escalating matched dose of placebo"
118082|NCT01896700|O1|Outcome|Methylphenidate|"Intervention: An escalating dose of methylphenidate taken by mouth: 20mg for 2 weeks, 40mg for 2 weeks, 60mg for 2 weeks. All doses divided twice/day.~Other name: Ritalin~Methylphenidate: Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each"
118083|NCT01896700|E2|Reported Event|Placebo|"Placebo pill, bid for 6 weeks~Placebo: Escalating matched dose of placebo"
118084|NCT01896700|E1|Reported Event|Methylphenidate|"Intervention: An escalating dose of methylphenidate taken by mouth: 20mg for 2 weeks, 40mg for 2 weeks, 60mg for 2 weeks. All doses divided twice/day.~Other name: Ritalin~Methylphenidate: Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each"
118085|NCT01896687|B3|Baseline|Total|Total of all reporting groups
118086|NCT01896687|B2|Baseline|Sham Scrambler Treatment|"Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days~Scrambler: Electrotherapy"
118087|NCT01896687|B1|Baseline|Scrambler Therapy|"Scrambler therapy applied to region of low back pain for 30 minutes x 10 days~Scrambler: Electrotherapy"
118088|NCT01896687|P2|Participant Flow|Sham Scrambler Treatment|"Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days~Scrambler: Electrotherapy"
118089|NCT01896687|P1|Participant Flow|Scrambler Therapy|"Scrambler therapy applied to region of low back pain for 30 minutes x 10 days~Scrambler: Electrotherapy"
118090|NCT01896687|O2|Outcome|Sham Scrambler Treatment|"Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days~Scrambler: Electrotherapy"
118091|NCT01896687|O1|Outcome|Scrambler Therapy|"Scrambler therapy applied to region of low back pain for 30 minutes x 10 days~Scrambler: Electrotherapy"
118092|NCT01896687|E2|Reported Event|Sham Scrambler Treatment|"Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days~Scrambler: Electrotherapy"
118093|NCT01896687|E1|Reported Event|Scrambler Therapy|"Scrambler therapy applied to region of low back pain for 30 minutes x 10 days~Scrambler: Electrotherapy"
118094|NCT01896557|B3|Baseline|Total|Total of all reporting groups
118095|NCT01896557|B2|Baseline|Ranitidine|Ranitidine 150 mg BID oral route was added to clopidogrel.
118096|NCT01896557|B1|Baseline|Omeprazole|"Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.~omeprazole: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated."
118097|NCT01896557|P2|Participant Flow|Ranitidine|Ranitidine 150 mg BID oral route was added to clopidogrel.
118098|NCT01896557|P1|Participant Flow|Omeprazole|"Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.~omeprazole: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated."
118099|NCT01896557|O2|Outcome|Ranitidine|Ranitidine 150 mg BID oral route was added to clopidogrel.
118100|NCT01896557|O1|Outcome|Omeprazole|"Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.~omeprazole: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated."
118101|NCT01896557|O2|Outcome|Ranitidine|Ranitidine 150 mg BID oral route was added to clopidogrel.
118102|NCT01896557|O1|Outcome|Omeprazole|"Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.~omeprazole: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated."
118103|NCT01896557|E2|Reported Event|Ranitidine|Ranitidine 150 mg BID oral route was added to clopidogrel.
118104|NCT01896557|E1|Reported Event|Omeprazole|"Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.~omeprazole: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated."
118105|NCT01896544|B4|Baseline|Total|Total of all reporting groups
118106|NCT01896544|B3|Baseline|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
118107|NCT01896544|B2|Baseline|Placebo|"Oral suspension of placebo cholecalciferol~Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
118108|NCT01896544|B1|Baseline|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
118109|NCT01896544|P3|Participant Flow|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
118110|NCT01896544|P2|Participant Flow|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
118111|NCT01896544|P1|Participant Flow|Placebo|"Oral suspension of placebo cholecalciferol~Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
118112|NCT01896544|O3|Outcome|Cholecalciferol Dose 2|Oral suspension of cholecalciferol 400,000 IU
118113|NCT01896544|O2|Outcome|Cholecalciferol Dose 1|Oral suspension cholecalciferol 200,000 IU
118114|NCT01896544|O1|Outcome|Placebo|Oral suspension of placebo cholecalciferol
118115|NCT01896544|O3|Outcome|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
118116|NCT01896544|O2|Outcome|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
118118|NCT01896544|O3|Outcome|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
118119|NCT01896544|O2|Outcome|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
118120|NCT01896544|O1|Outcome|Placebo|"Oral suspension of placebo cholecalciferol~Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
118121|NCT01896544|O3|Outcome|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
118122|NCT01896544|O2|Outcome|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
118123|NCT01896544|O1|Outcome|Placebo|"Oral suspension of placebo cholecalciferol~Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
118124|NCT01896544|O3|Outcome|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
118125|NCT01896544|O2|Outcome|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
118126|NCT01896544|O1|Outcome|Placebo|"Oral suspension of placebo cholecalciferol~Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
118127|NCT01896544|E3|Reported Event|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
118128|NCT01896544|E2|Reported Event|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
118129|NCT01896544|E1|Reported Event|Placebo|"Oral suspension of placebo cholecalciferol~Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
118130|NCT01896297|B1|Baseline|Dabigatran Etexilate|Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
118131|NCT01896297|P1|Participant Flow|Dabigatran Etexilate|Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
118132|NCT01896297|O1|Outcome|Dabigatran Etexilate|Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
118133|NCT01896297|O1|Outcome|Dabigatran Etexilate|Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
118134|NCT01896297|E1|Reported Event|Dabigatran Etexilate|Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
118135|NCT01896232|B3|Baseline|Total|Total of all reporting groups
118136|NCT01896232|B2|Baseline|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
118137|NCT01896232|B1|Baseline|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
118138|NCT01896232|P2|Participant Flow|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
118139|NCT01896232|P1|Participant Flow|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
118140|NCT01896232|O2|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
118141|NCT01896232|O1|Outcome|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
118142|NCT01896232|O2|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
118143|NCT01896232|O1|Outcome|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
118144|NCT01896232|O2|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
120397|NCT01884545|O4|Outcome|Non-Genetic Risk Counseling|Patients who did not receive genetic risk counseling
118145|NCT01896232|O1|Outcome|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
118146|NCT01896232|O2|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
118147|NCT01896232|O1|Outcome|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
118148|NCT01896232|O2|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
118149|NCT01896232|O1|Outcome|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
118150|NCT01896232|O2|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
118151|NCT01896232|O1|Outcome|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
118152|NCT01896232|O2|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
118153|NCT01896232|O1|Outcome|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
118154|NCT01896232|O2|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
118155|NCT01896232|O1|Outcome|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
118156|NCT01896232|E2|Reported Event|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
118157|NCT01896232|E1|Reported Event|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
118158|NCT01896206|B1|Baseline|CNAP Monitor|"Subjects undergoing bariatric surgery and monitored using the CNAP monitor.~CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor."
118159|NCT01896206|P1|Participant Flow|CNAP Monitor|"Subjects undergoing bariatric surgery and monitored using the CNAP monitor.~CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor."
118160|NCT01896206|O1|Outcome|CNAP Monitor|"Subjects undergoing bariatric surgery and monitored using the CNAP monitor.~CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor."
118161|NCT01896206|E1|Reported Event|CNAP Monitor|"Subjects undergoing bariatric surgery and monitored using the CNAP monitor.~CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor."
118162|NCT01896193|B5|Baseline|Total|Total of all reporting groups
118163|NCT01896193|B4|Baseline|SOF+RBV 24 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
118164|NCT01896193|B3|Baseline|SOF+RBV 16 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
118165|NCT01896193|B2|Baseline|SOF+RBV 24 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
118166|NCT01896193|B1|Baseline|SOF+RBV 16 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
118167|NCT01896193|P2|Participant Flow|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
118168|NCT01896193|P1|Participant Flow|SOF+RBV 16 Weeks|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 16 weeks
118169|NCT01896193|O4|Outcome|SOF+RBV 24 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
118170|NCT01896193|O3|Outcome|SOF+RBV 16 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
118171|NCT01896193|O2|Outcome|SOF+RBV 24 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
118172|NCT01896193|O1|Outcome|SOF+RBV 16 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
118173|NCT01896193|O4|Outcome|SOF+RBV 24 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
118174|NCT01896193|O3|Outcome|SOF+RBV 16 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
118175|NCT01896193|O2|Outcome|SOF+RBV 24 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
118176|NCT01896193|O1|Outcome|SOF+RBV 16 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
118177|NCT01896193|O4|Outcome|SOF+RBV 24 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
118178|NCT01896193|O3|Outcome|SOF+RBV 16 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
118179|NCT01896193|O2|Outcome|SOF+RBV 24 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
118180|NCT01896193|O1|Outcome|SOF+RBV 16 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
118181|NCT01896193|O4|Outcome|SOF+RBV 24 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
118182|NCT01896193|O3|Outcome|SOF+RBV 16 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
118183|NCT01896193|O2|Outcome|SOF+RBV 24 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
118184|NCT01896193|O1|Outcome|SOF+RBV 16 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
118185|NCT01896193|O4|Outcome|SOF+RBV 24 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
118186|NCT01896193|O3|Outcome|SOF+RBV 16 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
118187|NCT01896193|O2|Outcome|SOF+RBV 24 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
118188|NCT01896193|O1|Outcome|SOF+RBV 16 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
118189|NCT01896193|E2|Reported Event|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
118190|NCT01896193|E1|Reported Event|SOF+RBV 16 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks
118191|NCT01896115|B3|Baseline|Total|Total of all reporting groups
118192|NCT01896115|B2|Baseline|All Arms (Phase 2)|Patients with a Vercise DBS system programmed to 60 microseconds pulse width
118193|NCT01896115|B1|Baseline|All Arms (Phase 1)|Patients with a Vercise DBS system programmed to 30 microseconds pulse width
118194|NCT01896115|P2|Participant Flow|All Arms (Phase 2)|"Patients with a Vercise DBS system programmed to 30 microseconds pulse width~Patients with a Vercise DBS system programmed to 60 microseconds pulse width~Patients with a Vercise DBS system programmed to steer current~Patients with a Vercise DBS system programmed to single contact stimulation"
118195|NCT01896115|P1|Participant Flow|All Arms (Phase 1)|"Patients with a Vercise DBS system programmed to 30 microseconds pulse width~Patients with a Vercise DBS system programmed to 60 microseconds pulse width~Patients with a Vercise DBS system programmed to steer current ventrally~Patients with a Vercise DBS system programmed to steer current dorsally."
118196|NCT01896115|O4|Outcome|Dorsal Current Steering|Patients with a Vercise DBS system programmed to steer current dorsally
118197|NCT01896115|O3|Outcome|Ventral Current Steering|Patients with a Vercise DBS system programmed to steer current ventrally
118198|NCT01896115|O2|Outcome|Conventional PW|Patients with a Vercise DBS system programmed to 60 microseconds pulse width
118199|NCT01896115|O1|Outcome|Short PW|Patients with a Vercise DBS system programmed to 30 microseconds pulse width
118200|NCT01896115|O4|Outcome|Dorsal Current Steering|Patients with a Vercise DBS system programmed to steer current dorsally
118201|NCT01896115|O3|Outcome|Ventral Current Steering|Patients with a Vercise DBS system programmed to steer current ventrally
118202|NCT01896115|O2|Outcome|Conventional PW|Patients with a Vercise DBS system programmed to 60 microseconds pulse width
118203|NCT01896115|O1|Outcome|Short PW|Patients with a Vercise DBS system programmed to 30 microseconds pulse width
118204|NCT01896115|O2|Outcome|Dorsal Current Steering|Patients with a Vercise DBS system programmed to steer current dorsally
118205|NCT01896115|O1|Outcome|Ventral Current Steering|Patients with a Vercise DBS system programmed to steer current ventrally
118206|NCT01896115|O2|Outcome|Current Steering|All 24 patients analyzed for secondary endpoints received both single contact stimulation and current steering stimulation.
118207|NCT01896115|O1|Outcome|Single Contact|All 24 patients analyzed for secondary endpoints received both single contact stimulation and current steering stimulation.
118208|NCT01896115|O2|Outcome|Current Steering|All 24 patients analyzed for secondary endpoints received both single contact stimulation and current steering stimulation.
118209|NCT01896115|O1|Outcome|Single Contact|All 24 patients analyzed for secondary endpoints received both single contact stimulation and current steering stimulation.
118210|NCT01896115|O2|Outcome|Current Steering|All 24 patients analyzed for secondary endpoints received both single contact stimulation and current steering stimulation.
118211|NCT01896115|O1|Outcome|Single Contact|All 24 patients analyzed for secondary endpoints received both single contact stimulation and current steering stimulation.
118212|NCT01896115|O2|Outcome|Conventional PW|Patients with a Vercise DBS system programmed to 60 microseconds pulse width
118213|NCT01896115|O1|Outcome|Short PW|Patients with a Vercise DBS system programmed to 30 microseconds pulse width
118214|NCT01896115|O2|Outcome|Conventional PW|Patients with a Vercise DBS system programmed to 60 microseconds pulse width
118215|NCT01896115|O1|Outcome|Short PW|Patients with a Vercise DBS system programmed to 30 microseconds pulse width
118216|NCT01896115|E1|Reported Event|All Arms|"Patients with a Vercise DBS system programmed to 4 different settings including:~Short pulse widths (30 microseconds)~Conventional pulse widths (60 microseconds)~Steering current ventrally~Steering current dorsally"
118217|NCT01896050|B3|Baseline|Total|Total of all reporting groups
118218|NCT01896050|B2|Baseline|Tamoxifen|Subjects who started treatment with tamoxifen
118219|NCT01896050|B1|Baseline|AI Therapy|Subjects who started treatment with any of the three aromatase inhibitor (AI) medications
118220|NCT01896050|P2|Participant Flow|Tamoxifen|Subjects who started treatment with tamoxifen
118221|NCT01896050|P1|Participant Flow|AI Therapy|Subjects who started treatment with any of the three aromatase inhibitor (AI) medications
118222|NCT01896050|O2|Outcome|Tamoxifen|Tamoxifen-treated patients
118223|NCT01896050|O1|Outcome|Aromatase Inhibitor|Aromatase inhibitor-treated patients
118224|NCT01896050|O2|Outcome|Tamoxifen|Subjects who started treatment with tamoxifen
118225|NCT01896050|O1|Outcome|AI Therapy|Subjects who started treatment with any of the three aromatase inhibitor (AI) medications
118226|NCT01896050|O2|Outcome|Tamoxifen|Subjects who started treatment with tamoxifen
118227|NCT01896050|O1|Outcome|AI Therapy|Subjects who started treatment with any of the three aromatase inhibitor (AI) medications
118228|NCT01896050|E2|Reported Event|Tamoxifen|Subjects who started treatment with tamoxifen
118229|NCT01896050|E1|Reported Event|AI Therapy|Subjects who started treatment with any of the three aromatase inhibitor (AI) medications
118230|NCT01895946|B3|Baseline|Total|Total of all reporting groups
118231|NCT01895946|B2|Baseline|Part B|Part B of the study
118232|NCT01895946|B1|Baseline|Part A|Part A of the study
118233|NCT01895946|P2|Participant Flow|Part B|Part B of the study
118234|NCT01895946|P1|Participant Flow|Part A|Part A of the study
118235|NCT01895946|O2|Outcome|Part B|Part B of the study
118236|NCT01895946|O1|Outcome|Part A|Part A of the study
118237|NCT01895946|O2|Outcome|Part B|Part B of the study
118238|NCT01895946|O1|Outcome|Part A|Part A of the study
118239|NCT01895946|O2|Outcome|Part B|Part B of the study
118240|NCT01895946|O1|Outcome|Part A|Part A of the study
118241|NCT01895946|O2|Outcome|Part B|Part B of the study
118242|NCT01895946|O1|Outcome|Part A|Part A of the study
118243|NCT01895946|O2|Outcome|Part B|Part B of the study
118244|NCT01895946|O1|Outcome|Part A|Part A of the study
118245|NCT01895946|O2|Outcome|Part B|Part B of the study
118246|NCT01895946|O1|Outcome|Part A|Part A of the study
118247|NCT01895946|O2|Outcome|Part B|Part B of the study
118248|NCT01895946|O1|Outcome|Part A|Part A of the study
118249|NCT01895946|E2|Reported Event|Part B|Part B of the study
118250|NCT01895946|E1|Reported Event|Part A|Part A of the study
118251|NCT01895634|B1|Baseline|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
118252|NCT01895634|P1|Participant Flow|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
118253|NCT01895634|O1|Outcome|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
118254|NCT01895634|O1|Outcome|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
118255|NCT01895634|O1|Outcome|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
118256|NCT01895634|O1|Outcome|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
118257|NCT01895634|O1|Outcome|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
118258|NCT01895634|E1|Reported Event|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
118259|NCT01895608|B5|Baseline|Total|Total of all reporting groups
118260|NCT01895608|B4|Baseline|Cognitive Training (General Cognition)|"General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation.~Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation."
118261|NCT01895608|B3|Baseline|Cognitive Training (Speed of Processing)|"Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field.~Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field."
118262|NCT01895608|B2|Baseline|Standard Balance Rehabilitation|"Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.~Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands."
120398|NCT01884545|O3|Outcome|Genetic Risk Counseling|Patients who received genetic risk counseling
118263|NCT01895608|B1|Baseline|Balance Rehabilitation + Dual-task Practice|"Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task.~Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant"
118264|NCT01895608|P4|Participant Flow|Cognitive Training (General Cognition)|"General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation.~Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation."
118265|NCT01895608|P3|Participant Flow|Cognitive Training (Speed of Processing)|"Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field.~Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field."
118266|NCT01895608|P2|Participant Flow|Standard Balance Rehabilitation|"Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.~Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands."
118267|NCT01895608|P1|Participant Flow|Balance Rehabilitation + Dual-task Practice|"Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task.~Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant"
118268|NCT01895608|O4|Outcome|Cognitive Training (General Cognition)|"General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation.~Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation."
118269|NCT01895608|O3|Outcome|Cognitive Training (Speed of Processing)|"Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field.~Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field."
118270|NCT01895608|O2|Outcome|Standard Balance Rehabilitation|"Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.~Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands."
118271|NCT01895608|O1|Outcome|Balance Rehabilitation + Dual-task Practice|"Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task.~Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant"
118272|NCT01895608|O4|Outcome|Cognitive Training (General Cognition)|"General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation.~Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation."
118273|NCT01895608|O3|Outcome|Cognitive Training (Speed of Processing)|"Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field.~Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field."
118274|NCT01895608|O2|Outcome|Standard Balance Rehabilitation|"Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.~Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands."
118307|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
118275|NCT01895608|O1|Outcome|Balance Rehabilitation + Dual-task Practice|"Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task.~Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant"
118276|NCT01895608|O4|Outcome|Cognitive Training (General Cognition)|"General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation.~Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation."
118277|NCT01895608|O3|Outcome|Cognitive Training (Speed of Processing)|"Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field.~Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field."
118278|NCT01895608|O2|Outcome|Standard Balance Rehabilitation|"Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.~Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands."
118279|NCT01895608|O1|Outcome|Balance Rehabilitation + Dual-task Practice|"Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task.~Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant"
118280|NCT01895608|O4|Outcome|Cognitive Training (General Cognition)|"General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation.~Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation."
118281|NCT01895608|O3|Outcome|Cognitive Training (Speed of Processing)|"Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field.~Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field."
118282|NCT01895608|O2|Outcome|Standard Balance Rehabilitation|"Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.~Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands."
118283|NCT01895608|O1|Outcome|Balance Rehabilitation + Dual-task Practice|"Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task.~Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant"
118284|NCT01895608|O4|Outcome|Cognitive Training (General Cognition)|"General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation.~Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation."
118285|NCT01895608|O3|Outcome|Cognitive Training (Speed of Processing)|"Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field.~Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field."
118286|NCT01895608|O2|Outcome|Standard Balance Rehabilitation|"Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.~Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands."
118308|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
118287|NCT01895608|O1|Outcome|Balance Rehabilitation + Dual-task Practice|"Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task.~Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant"
118288|NCT01895608|O4|Outcome|Cognitive Training (General Cognition)|"General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation.~Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation."
118289|NCT01895608|O3|Outcome|Cognitive Training (Speed of Processing)|"Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field.~Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field."
118290|NCT01895608|O2|Outcome|Standard Balance Rehabilitation|"Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.~Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands."
118291|NCT01895608|O1|Outcome|Balance Rehabilitation + Dual-task Practice|"Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task.~Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant"
118292|NCT01895608|E4|Reported Event|Cognitive Training (General Cognition)|"General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation.~Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation."
118293|NCT01895608|E3|Reported Event|Cognitive Training (Speed of Processing)|"Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field.~Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field."
118294|NCT01895608|E2|Reported Event|Standard Balance Rehabilitation|"Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.~Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands."
118295|NCT01895608|E1|Reported Event|Balance Rehabilitation + Dual-task Practice|"Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task.~Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant"
118296|NCT01895543|B1|Baseline|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
118297|NCT01895543|P1|Participant Flow|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
118298|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
118299|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
118300|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
118301|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
118302|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
118303|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
118304|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
118305|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
118306|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
120399|NCT01884545|O2|Outcome|Non-Health Coaching|Participants who did not receive health coaching
118309|NCT01895543|E1|Reported Event|EBX 10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
118310|NCT01895452|B3|Baseline|Total|Total of all reporting groups
118311|NCT01895452|B2|Baseline|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
118312|NCT01895452|B1|Baseline|ALKS 9072, Low|ALKS 9072, Low : IM injection, given monthly
118313|NCT01895452|P2|Participant Flow|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
118314|NCT01895452|P1|Participant Flow|ALKS 9072, Low|ALKS 9072, Low : IM injection, given monthly
118315|NCT01895452|O2|Outcome|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
118316|NCT01895452|O1|Outcome|ALKS 9072, Low|ALKS 9072, Low : IM injection, given monthly
118317|NCT01895452|O2|Outcome|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
118318|NCT01895452|O1|Outcome|ALKS 9072, Low|ALKS 9072, Low : IM injection, given monthly
118319|NCT01895452|O2|Outcome|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
118320|NCT01895452|O1|Outcome|ALKS 9072, Low|ALKS 9072, Low : IM injection, given monthly
118321|NCT01895452|E2|Reported Event|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
118322|NCT01895452|E1|Reported Event|ALKS 9072, Low|ALKS 9072, Low : IM injection, given monthly
118323|NCT01895335|B1|Baseline|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
118324|NCT01895335|P1|Participant Flow|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling once daily (QD) orally for 48 weeks.
118325|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
118326|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
118327|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
118328|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
118329|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
118330|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
118331|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
118332|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
118333|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
118334|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
118335|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
118336|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
118337|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
118338|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
118339|NCT01895335|E1|Reported Event|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
118340|NCT01895322|B1|Baseline|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.~- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)~OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
118341|NCT01895322|P1|Participant Flow|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.~- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)~OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
118342|NCT01895322|O1|Outcome|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.~- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)~OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
118343|NCT01895322|O1|Outcome|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.~- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)~OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
118369|NCT01895270|E2|Reported Event|Placebo|"Placebo will consist of microcrystalline cellulose. Two placebo capsules will be administered per day starting week 1 day 3 through the end of the isradipine taper.~Placebo: Placebo will consist of microcrystalline cellulose."
118904|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
118344|NCT01895322|O1|Outcome|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an increase of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.~- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)~OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
118345|NCT01895322|O1|Outcome|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.~- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)~OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
118346|NCT01895322|E1|Reported Event|OPC-41061|OPC-41061
118347|NCT01895309|B3|Baseline|Total|Total of all reporting groups
118348|NCT01895309|B2|Baseline|Enbrel (Etanercept)|Enbrel 50 mg/week via subcutaneous injection
118349|NCT01895309|B1|Baseline|SB4 (Proposed Biosimilar to Etanercept)|SB4 50 mg/week via subcutaneous injection
118350|NCT01895309|P2|Participant Flow|Enbrel (Etanercept)|Enbrel 50 mg/week via subcutaneous injection
118351|NCT01895309|P1|Participant Flow|SB4 (Proposed Biosimilar to Etanercept)|SB4 50 mg/week via subcutaneous injection
118352|NCT01895309|O4|Outcome|Enbrel (Etanercept) at Week 52|"Enbrel 50 mg/week via subcutaneous injection~Enbrel (etanercept)"
118353|NCT01895309|O3|Outcome|SB4 (Proposed Biosimilar to Etanercept) at Week 52|"SB4 50 mg/week via subcutaneous injection~SB4 (proposed biosimilar to etanercept)"
118354|NCT01895309|O2|Outcome|Enbrel (Etanercept) at Week 24|"Enbrel 50 mg/week via subcutaneous injection~Enbrel (etanercept)"
118355|NCT01895309|O1|Outcome|SB4 (Proposed Biosimilar to Etanercept) at Week 24|"SB4 50 mg/week via subcutaneous injection~SB4 (proposed biosimilar to etanercept)"
118356|NCT01895309|O2|Outcome|Enbrel (Etanercept)|Enbrel 50 mg/week via subcutaneous injection
118357|NCT01895309|O1|Outcome|SB4 (Proposed Biosimilar to Etanercept)|SB4 50 mg/week via subcutaneous injection
118358|NCT01895309|O2|Outcome|Enbrel (Etanercept)|Enbrel 50 mg/week via subcutaneous injection
118359|NCT01895309|O1|Outcome|SB4 (Proposed Biosimilar to Etanercept)|SB4 50 mg/week via subcutaneous injection
118360|NCT01895309|E2|Reported Event|Enbrel (Etanercept)|"Enbrel 50 mg/week via subcutaneous injection~Enbrel (etanercept)"
118361|NCT01895309|E1|Reported Event|SB4 (Proposed Biosimilar to Etanercept)|"SB4 50 mg/week via subcutaneous injection~SB4 (proposed biosimilar to etanercept)"
118362|NCT01895270|B3|Baseline|Total|Total of all reporting groups
118363|NCT01895270|B2|Baseline|Placebo|"Placebo will consist of microcrystalline cellulose. Two placebo capsules will be administered per day starting week 1 day 3 through the end of the isradipine taper.~Placebo: Placebo will consist of microcrystalline cellulose."
118364|NCT01895270|B1|Baseline|Isradipine|"Isradipine controlled-release formulation, 10 mg/day maintenance dose, will be administered according to the following dose procedures: Isradipine ingestion will occur under supervision 6 days per week, and a take-home dose will be given on Saturday for participants to take on Sunday. The initial dose of isradipine or placebo will be given on Day 3 of Week 1. The initial dose of isradipine will be 5 mg/day; the dose will increase to 10 mg/day on Day 3 of Week 3 and will continue through Day 2 of Week 7. On Day 3 of Week 7, isradipine will be decreased to 5 mg/day for 7 days. On Days 3–5 of Week 8, all participants will receive placebo. If ISR side effects are too severe at the 10-mg dose, isradipine will be decreased to 5 mg/day. If ISR side effects are too severe at 5 mg/day, isradipine will be discontinued and the participant will be discharged from the study and referred to local treatment agencies.~Isradipine: Isradipine extended release formulation"
118365|NCT01895270|P2|Participant Flow|Placebo|"Placebo will consist of microcrystalline cellulose. Two placebo capsules will be administered per day starting week 1 day 3 through the end of the isradipine taper.~Placebo: Placebo will consist of microcrystalline cellulose."
118366|NCT01895270|P1|Participant Flow|Isradipine|"Isradipine controlled-release formulation, 10 mg/day maintenance dose, will be administered according to the following dose procedures: Isradipine ingestion will occur under supervision 6 days per week, and a take-home dose will be given on Saturday for participants to take on Sunday. The initial dose of isradipine or placebo will be given on Day 3 of Week 1. The initial dose of isradipine will be 5 mg/day; the dose will increase to 10 mg/day on Day 3 of Week 3 and will continue through Day 2 of Week 7. On Day 3 of Week 7, isradipine will be decreased to 5 mg/day for 7 days. On Days 3–5 of Week 8, all participants will receive placebo. If ISR side effects are too severe at the 10-mg dose, isradipine will be decreased to 5 mg/day. If ISR side effects are too severe at 5 mg/day, isradipine will be discontinued and the participant will be discharged from the study and referred to local treatment agencies.~Isradipine: Isradipine extended release formulation"
118367|NCT01895270|O2|Outcome|Placebo|"Placebo will consist of microcrystalline cellulose. Two placebo capsules will be administered per day starting week 1 day 3 through the end of the isradipine taper.~Placebo: Placebo will consist of microcrystalline cellulose."
118368|NCT01895270|O1|Outcome|Isradipine|"Isradipine controlled-release formulation, 10 mg/day maintenance dose, will be administered according to the following dose procedures: Isradipine ingestion will occur under supervision 6 days per week, and a take-home dose will be given on Saturday for participants to take on Sunday. The initial dose of isradipine or placebo will be given on Day 3 of Week 1. The initial dose of isradipine will be 5 mg/day; the dose will increase to 10 mg/day on Day 3 of Week 3 and will continue through Day 2 of Week 7. On Day 3 of Week 7, isradipine will be decreased to 5 mg/day for 7 days. On Days 3–5 of Week 8, all participants will receive placebo. If ISR side effects are too severe at the 10-mg dose, isradipine will be decreased to 5 mg/day. If ISR side effects are too severe at 5 mg/day, isradipine will be discontinued and the participant will be discharged from the study and referred to local treatment agencies.~Isradipine: Isradipine extended release formulation"
118477|NCT01894620|B3|Baseline|Total|Total of all reporting groups
118370|NCT01895270|E1|Reported Event|Isradipine|"Isradipine controlled-release formulation, 10 mg/day maintenance dose, will be administered according to the following dose procedures: Isradipine ingestion will occur under supervision 6 days per week, and a take-home dose will be given on Saturday for participants to take on Sunday. The initial dose of isradipine or placebo will be given on Day 3 of Week 1. The initial dose of isradipine will be 5 mg/day; the dose will increase to 10 mg/day on Day 3 of Week 3 and will continue through Day 2 of Week 7. On Day 3 of Week 7, isradipine will be decreased to 5 mg/day for 7 days. On Days 3–5 of Week 8, all participants will receive placebo. If ISR side effects are too severe at the 10-mg dose, isradipine will be decreased to 5 mg/day. If ISR side effects are too severe at 5 mg/day, isradipine will be discontinued and the participant will be discharged from the study and referred to local treatment agencies.~Isradipine: Isradipine extended release formulation"
118371|NCT01895127|B3|Baseline|Total|Total of all reporting groups
118372|NCT01895127|B2|Baseline|Soliris (Eculizumab)|"1200 mg first dose (Time: Screening/Week “0”, after Biopsy Proven AMR)~900 mg weekly for 4 doses (Weeks 1, 2, 3, 4)~1200 mg week 5~Week 6: If donor specific antibody < 50% of baseline DSA then no further treatment, otherwise 1200 mg weeks 7, 9~Eculizumab"
118373|NCT01895127|B1|Baseline|Standard of Care|"Plasmapheresis (PP) x 3, at 40-60 cc/kg.~Immunoglobulin (IVIg), to be administered after each PP~Immunoglobulin~Plasmapheresis"
118374|NCT01895127|P2|Participant Flow|Soliris (Eculizumab)|"1200 mg first dose (Time: Screening/Week “0”, after Biopsy Proven AMR)~900 mg weekly for 4 doses (Weeks 1, 2, 3, 4)~1200 mg week 5~Week 6: If donor specific antibody < 50% of baseline DSA then no further treatment, otherwise 1200 mg weeks 7, 9~Eculizumab"
118375|NCT01895127|P1|Participant Flow|Standard of Care|"Plasmapheresis (PP) x 3, at 40-60 cc/kg.~Immunoglobulin (IVIg), to be administered after each PP~Immunoglobulin~Plasmapheresis"
118376|NCT01895127|O3|Outcome|Standard of Care + Soliris (Eculizumab)|Subjects received both standard of care and Soliris treatment between Week 0 and Month 3
118377|NCT01895127|O2|Outcome|Soliris (Eculizumab)|"1200 mg first dose (Time: Screening/Week “0”, after Biopsy Proven AMR)~900 mg weekly for 4 doses (Weeks 1, 2, 3, 4)~1200 mg week 5~Week 6: If donor specific antibody < 50% of baseline DSA then no further treatment, otherwise 1200 mg weeks 7, 9~Eculizumab"
118378|NCT01895127|O1|Outcome|Standard of Care|"Plasmapheresis (PP) x 3, at 40-60 cc/kg.~Immunoglobulin (IVIg), to be administered after each PP~Immunoglobulin~Plasmapheresis"
118379|NCT01895127|E2|Reported Event|Soliris (Eculizumab)|"1200 mg first dose (Time: Screening/Week “0”, after Biopsy Proven AMR)~900 mg weekly for 4 doses (Weeks 1, 2, 3, 4)~1200 mg week 5~Week 6: If donor specific antibody < 50% of baseline DSA then no further treatment, otherwise 1200 mg weeks 7, 9~Eculizumab"
118380|NCT01895127|E1|Reported Event|Standard of Care|"Plasmapheresis (PP) x 3, at 40-60 cc/kg.~Immunoglobulin (IVIg), to be administered after each PP~Immunoglobulin~Plasmapheresis"
118381|NCT01895101|B4|Baseline|Total|Total of all reporting groups
118382|NCT01895101|B3|Baseline|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).~2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
118383|NCT01895101|B2|Baseline|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~In this arm the subjects receives as in standard care no pericardial lavage."
118384|NCT01895101|B1|Baseline|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.~Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
118385|NCT01895101|P3|Participant Flow|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).~2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
118386|NCT01895101|P2|Participant Flow|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~In this arm the subjects receives as in standard care no pericardial lavage."
118387|NCT01895101|P1|Participant Flow|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.~Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
118388|NCT01895101|O3|Outcome|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).~2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
118389|NCT01895101|O2|Outcome|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~In this arm the subjects receives as in standard care no pericardial lavage."
118684|NCT01893879|B2|Baseline|Placebo for Study Drug|"Patients receive placebo three times daily, orally, for up to 1 year in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis will be performed.~placebo for study drug: Given PO~laboratory biomarker analysis: Correlative studies"
118390|NCT01895101|O1|Outcome|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.~Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
118391|NCT01895101|O3|Outcome|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).~2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
118392|NCT01895101|O2|Outcome|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~In this arm the subjects receives as in standard care no pericardial lavage."
118393|NCT01895101|O1|Outcome|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.~Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
118394|NCT01895101|O3|Outcome|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).~2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
118395|NCT01895101|O2|Outcome|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~In this arm the subjects receives as in standard care no pericardial lavage."
118396|NCT01895101|O1|Outcome|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.~Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
118397|NCT01895101|E3|Reported Event|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).~2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
118398|NCT01895101|E2|Reported Event|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~In this arm the subjects receives as in standard care no pericardial lavage."
118399|NCT01895101|E1|Reported Event|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.~Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
118400|NCT01895088|B1|Baseline|Age, Categorical|Measure Type: Count of Participants
118401|NCT01895088|P1|Participant Flow|Patients Prev. Implanted With ACI7000PDT|"Prev. implanted in ACU-P08-020/020A study~AcuFocus Corneal Inlay ACI 7000 PDT: corneal inlay"
118402|NCT01895088|O1|Outcome|Patients Prev. Implanted With ACI7000PDT|"Prev. implanted in ACU-P08-020/020A study~AcuFocus Corneal Inlay ACI 7000 PDT: Inlay implanted in cornea for improvement of near vision"
118403|NCT01895088|E1|Reported Event|Patients Prev. Implanted With ACI7000PDT|"Prev. implanted in ACU-P08-020/020A study~AcuFocus Corneal Inlay ACI 7000 PDT: corneal inlay"
118404|NCT01895062|B3|Baseline|Total|Total of all reporting groups
118405|NCT01895062|B2|Baseline|no Intervention|Routine care is administered without the application of cNEP.
118406|NCT01895062|B1|Baseline|Active cNEP @ -45cmw|"cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.~Airway Management System (AMS): The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck.~The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway."
118407|NCT01895062|P2|Participant Flow|no Intervention|Routine care is administered without the application of cNEP.
118408|NCT01895062|P1|Participant Flow|Active cNEP @ -45cmw|"cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.~Airway Management System (AMS): The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck.~The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway."
118409|NCT01895062|O2|Outcome|no Intervention|Routine care is administered without the application of cNEP.
118410|NCT01895062|O1|Outcome|Active cNEP @ -45cmw|"cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.~Airway Management System (AMS): The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck.~The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway."
118411|NCT01895062|O2|Outcome|no Intervention|Routine care is administered without the application of cNEP.
136509|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
118412|NCT01895062|O1|Outcome|Active cNEP @ -45cmw|"cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.~Airway Management System (AMS): The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck.~The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway."
118413|NCT01895062|E2|Reported Event|no Intervention|Routine care is administered without the application of cNEP.
118414|NCT01895062|E1|Reported Event|Active cNEP @ -45cmw|"cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.~Airway Management System (AMS): The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck.~The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway."
118415|NCT01895036|B1|Baseline|Naltrexone|"PO naltrexone titration on a mixed inpatient/outpatient basis, followed by administration of Vivitrol four days following the 1st dose of naltrexone~Naltrexone"
118416|NCT01895036|P1|Participant Flow|Naltrexone|"PO naltrexone titration on a mixed inpatient/outpatient basis, followed by administration of Vivitrol four days following the 1st dose of naltrexone~Naltrexone"
118417|NCT01895036|O1|Outcome|Naltrexone|"PO naltrexone titration on a mixed inpatient/outpatient basis, followed by administration of Vivitrol four days following the 1st dose of naltrexone~Naltrexone"
118418|NCT01895036|E1|Reported Event|Naltrexone|"PO naltrexone titration on a mixed inpatient/outpatient basis, followed by administration of Vivitrol four days following the 1st dose of naltrexone~Naltrexone"
118419|NCT01894984|B3|Baseline|Total|Total of all reporting groups
118420|NCT01894984|B2|Baseline|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
118421|NCT01894984|B1|Baseline|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
118422|NCT01894984|P2|Participant Flow|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
118423|NCT01894984|P1|Participant Flow|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
118424|NCT01894984|O2|Outcome|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
118425|NCT01894984|O1|Outcome|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
118426|NCT01894984|O2|Outcome|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
118427|NCT01894984|O1|Outcome|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
118428|NCT01894984|O2|Outcome|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
118429|NCT01894984|O1|Outcome|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
118430|NCT01894984|O2|Outcome|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
118431|NCT01894984|O1|Outcome|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
118432|NCT01894984|O2|Outcome|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
118433|NCT01894984|O1|Outcome|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
118434|NCT01894984|O2|Outcome|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
118519|NCT01894256|B2|Baseline|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118435|NCT01894984|O1|Outcome|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
118436|NCT01894984|E2|Reported Event|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
118437|NCT01894984|E1|Reported Event|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
118438|NCT01894906|B3|Baseline|Total|Total of all reporting groups
118439|NCT01894906|B2|Baseline|Gambro 17R/21R (Group 2: Polyamide Membrane).|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate.
118440|NCT01894906|B1|Baseline|Baxter CT-190 (Group 1: Cellulose Triacetate Membrane)|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate.
118441|NCT01894906|P2|Participant Flow|Gambro 17R/21R (Group 2: Polyamide Membrane)|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate.
118442|NCT01894906|P1|Participant Flow|Baxter CT-190 (Group 1: Cellulose Triacetate Membrane)|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate.
118443|NCT01894906|O6|Outcome|Treatment F|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new Gambro 17R/21R PAES membrane dialyzer.
118444|NCT01894906|O5|Outcome|Treatment E|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment E was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, low blood flow rate, low dialysis flow rate, and new dialyzer.
118445|NCT01894906|O4|Outcome|Treatment D|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment D was one dialysis session with SFP added to the bicarbonate, with low bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
118446|NCT01894906|O3|Outcome|Treatment C|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment C was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and re-used dialyzer.
118447|NCT01894906|O2|Outcome|Treatment B|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
118448|NCT01894906|O1|Outcome|Control|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment A was one dialysis session without SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
118449|NCT01894906|O6|Outcome|Treatment F|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new Gambro 17R/21R PAES membrane dialyzer.
118520|NCT01894256|B1|Baseline|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
120400|NCT01884545|O1|Outcome|Health Coaching|Participants who received health coaching
118450|NCT01894906|O5|Outcome|Treatment E|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment E was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, low blood flow rate, low dialysis flow rate, and new dialyzer.
118451|NCT01894906|O4|Outcome|Treatment D|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment D was one dialysis session with SFP added to the bicarbonate, with low bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
118452|NCT01894906|O3|Outcome|Treatment C|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment C was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and re-used dialyzer.
118453|NCT01894906|O2|Outcome|Treatment B|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
118454|NCT01894906|O1|Outcome|Control|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment A was one dialysis session without SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
118455|NCT01894906|O1|Outcome|Treatment B|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
118456|NCT01894906|O3|Outcome|Baxter and Gambro Combined|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). This category includes the combined results of both groups.
118457|NCT01894906|O2|Outcome|Gambro Polyflux|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane).
118458|NCT01894906|O1|Outcome|Baxter CT-190|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane).
118459|NCT01894906|O6|Outcome|Treatment F|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new Gambro 17R/21R PAES membrane dialyzer.
118460|NCT01894906|O5|Outcome|Treatment E|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment E was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, low blood flow rate, low dialysis flow rate, and new dialyzer.
118461|NCT01894906|O4|Outcome|Treatment D|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment D was one dialysis session with SFP added to the bicarbonate, with low bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
118462|NCT01894906|O3|Outcome|Treatment C|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment C was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and re-used dialyzer.
118463|NCT01894906|O2|Outcome|Treatment B|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
118541|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
118464|NCT01894906|O1|Outcome|Control|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment A was one dialysis session without SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
118465|NCT01894906|E6|Reported Event|Treatment F|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new Gambro 17R/21R PAES membrane dialyzer.
118466|NCT01894906|E5|Reported Event|Treatment E|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment E was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, low blood flow rate, low dialysis flow rate, and new dialyzer.
118467|NCT01894906|E4|Reported Event|Treatment D|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment D was one dialysis session with SFP added to the bicarbonate, with low bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
118468|NCT01894906|E3|Reported Event|Treatment C|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment C was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and re-used dialyzer.
118469|NCT01894906|E2|Reported Event|Treatment B|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
118470|NCT01894906|E1|Reported Event|Control|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment A was one dialysis session without SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
118471|NCT01894672|B1|Baseline|LGX818|Patients With Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation will receive LGX818 capsules orally on a once -daily schedule (QD) dosing at a dose of 300 mg/day, 2 weeks on followed by a 2 week break. This schedule of 2 weeks on, followed by 2 weeks off, will continue for the duration of time the patients remains on the clinical trial. After the follow up visit patients will be contacted approximately every 12 weeks until they have received a subsequent therapy or until they have been off treatment for a year to monitor their survival.
118472|NCT01894672|P1|Participant Flow|LGX818|Patients With Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation will receive LGX818 capsules orally on a once -daily schedule (QD) dosing at a dose of 300 mg/day, 2 weeks on followed by a 2 week break. This schedule of 2 weeks on, followed by 2 weeks off, will continue for the duration of time the patients remains on the clinical trial. After the follow up visit patients will be contacted approximately every 12 weeks until they have received a subsequent therapy or until they have been off treatment for a year to monitor their survival.
118473|NCT01894672|O1|Outcome|LGX818|Patients With Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation will receive LGX818 capsules orally on a once -daily schedule (QD) dosing at a dose of 300 mg/day, 2 weeks on followed by a 2 week break. This schedule of 2 weeks on, followed by 2 weeks off, will continue for the duration of time the patients remains on the clinical trial. After the follow up visit patients will be contacted approximately every 12 weeks until they have received a subsequent therapy or until they have been off treatment for a year to monitor their survival.
118474|NCT01894672|O1|Outcome|LGX818|"LGX818 capsules will be administered orally on a once -daily schedule (QD) dosing at a dose of 300 mg/day, 2 weeks on followed by a 2 week break. This schedule of 2 weeks on, followed by 2 weeks off, will continue for the duration of time the patients remains on the clinical trial. After the follow up visit patients will be contacted approximately every 12 weeks until they have received a subsequent therapy or until they have been off treatment for a year to monitor their survival.~LGX818"
118475|NCT01894672|O1|Outcome|LGX818|Patients With Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation will receive LGX818 capsules orally on a once -daily schedule (QD) dosing at a dose of 300 mg/day, 2 weeks on followed by a 2 week break. This schedule of 2 weeks on, followed by 2 weeks off, will continue for the duration of time the patients remains on the clinical trial. After the follow up visit patients will be contacted approximately every 12 weeks until they have received a subsequent therapy or until they have been off treatment for a year to monitor their survival.
118476|NCT01894672|E1|Reported Event|LGX818|Patients With Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation will receive LGX818 capsules orally on a once -daily schedule (QD) dosing at a dose of 300 mg/day, 2 weeks on followed by a 2 week break. This schedule of 2 weeks on, followed by 2 weeks off, will continue for the duration of time the patients remains on the clinical trial. After the follow up visit patients will be contacted approximately every 12 weeks until they have received a subsequent therapy or until they have been off treatment for a year to monitor their survival.
118478|NCT01894620|B2|Baseline|rTMS Sham-real|"rTMS real-sham and rTMS sham-real interventions. Each patient will receive both real and sham treatment in two different blocks of time. The assessments after the sham treatment will serve as placebo effect compared to those after real treatment.~rTMS real-sham: In this intervention patients receive 4 weeks of rTMS treatment with real coil and then 4 weeks of treatment with sham coil; there will be 4 weeks of break between the two blocks of treatment.~rTMS sham-real: In this intervention patients receive 4 weeks of rTMS treatment with sham coil and then 4 weeks of treatment with real coil; there will be 4 weeks of break between the two blocks of treatment."
118479|NCT01894620|B1|Baseline|rTMS Real-sham|"rTMS real-sham and rTMS sham-real interventions. Each patient will receive both real and sham treatment in two different blocks of time. The assessments after the sham treatment will serve as placebo effect compared to those after real treatment.~rTMS real-sham: In this intervention patients receive 4 weeks of rTMS treatment with real coil and then 4 weeks of treatment with sham coil; there will be 4 weeks of break between the two blocks of treatment.~rTMS sham-real: In this intervention patients receive 4 weeks of rTMS treatment with sham coil and then 4 weeks of treatment with real coil; there will be 4 weeks of break between the two blocks of treatment."
118480|NCT01894620|P2|Participant Flow|rTMS Sham-real|"rTMS real-sham and rTMS sham-real interventions. Each patient will receive both real and sham treatment in two different blocks of time. The assessments after the sham treatment will serve as placebo effect compared to those after real treatment.~rTMS real-sham: In this intervention patients receive 4 weeks of rTMS treatment with real coil and then 4 weeks of treatment with sham coil; there will be 4 weeks of break between the two blocks of treatment.~rTMS sham-real: In this intervention patients receive 4 weeks of rTMS treatment with sham coil and then 4 weeks of treatment with real coil; there will be 4 weeks of break between the two blocks of treatment."
118481|NCT01894620|P1|Participant Flow|rTMS Real-sham|"rTMS real-sham and rTMS sham-real interventions. Each patient will receive both real and sham treatment in two different blocks of time. The assessments after the sham treatment will serve as placebo effect compared to those after real treatment.~rTMS real-sham: In this intervention patients receive 4 weeks of rTMS treatment with real coil and then 4 weeks of treatment with sham coil; there will be 4 weeks of break between the two blocks of treatment.~rTMS sham-real: In this intervention patients receive 4 weeks of rTMS treatment with sham coil and then 4 weeks of treatment with real coil; there will be 4 weeks of break between the two blocks of treatment."
118482|NCT01894620|O2|Outcome|rTMS Sham-real|"rTMS real-sham and rTMS sham-real interventions. Each patient will receive both real and sham treatment in two different blocks of time. The assessments after the sham treatment will serve as placebo effect compared to those after real treatment.~rTMS real-sham: In this intervention patients receive 4 weeks of rTMS treatment with real coil and then 4 weeks of treatment with sham coil; there will be 4 weeks of break between the two blocks of treatment.~rTMS sham-real: In this intervention patients receive 4 weeks of rTMS treatment with sham coil and then 4 weeks of treatment with real coil; there will be 4 weeks of break between the two blocks of treatment."
118483|NCT01894620|O1|Outcome|rTMS Real-sham|"rTMS real-sham and rTMS sham-real interventions. Each patient will receive both real and sham treatment in two different blocks of time. The assessments after the sham treatment will serve as placebo effect compared to those after real treatment.~rTMS real-sham: In this intervention patients receive 4 weeks of rTMS treatment with real coil and then 4 weeks of treatment with sham coil; there will be 4 weeks of break between the two blocks of treatment.~rTMS sham-real: In this intervention patients receive 4 weeks of rTMS treatment with sham coil and then 4 weeks of treatment with real coil; there will be 4 weeks of break between the two blocks of treatment."
118484|NCT01894620|O2|Outcome|rTMS With Real Coil|"rTMS real-sham and rTMS sham-real interventions. Each patient will receive both real and sham treatment in two different blocks of time. The assessments after the sham treatment will serve as placebo effect compared to those after real treatment.~rTMS real-sham: In this intervention patients receive 4 weeks of rTMS treatment with real coil and then 4 weeks of treatment with sham coil; there will be 4 weeks of break between the two blocks of treatment.~rTMS sham-real: In this intervention patients receive 4 weeks of rTMS treatment with sham coil and then 4 weeks of treatment with real coil; there will be 4 weeks of break between the two blocks of treatment."
118485|NCT01894620|O1|Outcome|rTMS With Sham Coil|"rTMS real-sham and rTMS sham-real interventions. Each patient will receive both real and sham treatment in two different blocks of time. The assessments after the sham treatment will serve as placebo effect compared to those after real treatment.~rTMS real-sham: In this intervention patients receive 4 weeks of rTMS treatment with real coil and then 4 weeks of treatment with sham coil; there will be 4 weeks of break between the two blocks of treatment.~rTMS sham-real: In this intervention patients receive 4 weeks of rTMS treatment with sham coil and then 4 weeks of treatment with real coil; there will be 4 weeks of break between the two blocks of treatment."
118486|NCT01894620|E2|Reported Event|rTMS With Real Coil|"rTMS real-sham and rTMS sham-real interventions. Each patient will receive both real and sham treatment in two different blocks of time. The assessments after the sham treatment will serve as placebo effect compared to those after real treatment.~rTMS real-sham: In this intervention patients receive 4 weeks of rTMS treatment with real coil and then 4 weeks of treatment with sham coil; there will be 4 weeks of break between the two blocks of treatment.~rTMS sham-real: In this intervention patients receive 4 weeks of rTMS treatment with sham coil and then 4 weeks of treatment with real coil; there will be 4 weeks of break between the two blocks of treatment."
118487|NCT01894620|E1|Reported Event|rTMS With Sham Coil|"rTMS real-sham and rTMS sham-real interventions. Each patient will receive both real and sham treatment in two different blocks of time. The assessments after the sham treatment will serve as placebo effect compared to those after real treatment.~rTMS real-sham: In this intervention patients receive 4 weeks of rTMS treatment with real coil and then 4 weeks of treatment with sham coil; there will be 4 weeks of break between the two blocks of treatment.~rTMS sham-real: In this intervention patients receive 4 weeks of rTMS treatment with sham coil and then 4 weeks of treatment with real coil; there will be 4 weeks of break between the two blocks of treatment."
118488|NCT01894607|B1|Baseline|Contrast Enhanced Intraoperative Ultrasound|During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
118939|NCT01892189|O2|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
118489|NCT01894607|P1|Participant Flow|Contrast Enhanced Intraoperative Ultrasound|During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
118490|NCT01894607|O1|Outcome|Contrast Enhanced Intraoperative Ultrasound|During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
118491|NCT01894607|O1|Outcome|Contrast Enhanced Intraoperative Ultrasound|During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
118492|NCT01894607|E1|Reported Event|Contrast Enhanced Intraoperative Ultrasound|During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
118493|NCT01894581|B3|Baseline|Total|Total of all reporting groups
118494|NCT01894581|B2|Baseline|Normal Weight|BMI 18-25 kg/m2
118495|NCT01894581|B1|Baseline|Obese|BMI >= 30 kg/m2
118496|NCT01894581|P2|Participant Flow|Normal Weight|BMI 18-25 kg/m2
118497|NCT01894581|P1|Participant Flow|Obese|BMI >= 30 kg/m2
118498|NCT01894581|O2|Outcome|Normal Weight|BMI 18-25 kg/m2
118499|NCT01894581|O1|Outcome|Obese|BMI >= 30 kg/m2
118500|NCT01894581|E2|Reported Event|Normal Weight|BMI 18-25 kg/m2
118501|NCT01894581|E1|Reported Event|Obese|BMI >= 30 kg/m2
118502|NCT01894555|B1|Baseline|Aspirin|"Participants treated with aspirin - there is no control group. Participant's baseline will act as their control.~Aspirin: 81 mg daily for 4 weeks"
118503|NCT01894555|P1|Participant Flow|Aspirin|"Participants treated with aspirin - there is no control group. Participant's baseline will act as their control.~Aspirin: 81 mg daily for 4 weeks"
118504|NCT01894555|O1|Outcome|Aspirin|"Participants treated with aspirin - there is no control group. Participant's baseline will act as their control.~Aspirin: 81 mg daily for 4 weeks"
118505|NCT01894555|E1|Reported Event|Aspirin|"Participants treated with aspirin - there is no control group. Participant's baseline will act as their control.~Aspirin: 81 mg daily for 4 weeks"
118506|NCT01894477|B3|Baseline|Total|Total of all reporting groups
118507|NCT01894477|B2|Baseline|Arm B (Treosulfan, Fludarabine Phosphate, TBI)|Treosulfan and fludarabine phosphate as in Arm A and undergo low-dose TBI on day 0.
118508|NCT01894477|B1|Baseline|Arm A (Treosulfan, Fludarabine Phosphate)|Treosulfan IV over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
118509|NCT01894477|P2|Participant Flow|Arm B (Treosulfan, Fludarabine Phosphate, TBI)|"CONDITIONING REGIMEN: Treosulfan and fludarabine phosphate as in Arm A and undergo low-dose TBI on day 0.~TRANSPLANT: Patients in both arms undergo allogeneic PBSC transplant or bone marrow transplant on day 0.~GVHD PROPHYLAXIS: Patients with a related donor receive tacrolimus PO every 8 or 12 hours on days -3 to 56 with taper to day 180. Beginning 4-6 hours after PBSC infusion, and mycophenolate mofetil PO every 12 hours to day 28. Patients with an unrelated donor receive tacrolimus PO every 8 or 12 hours on days -3 to 100 with taper to day 180. Beginning 4-6 hours after PBSC infusion, and mycophenolate mofetil PO every 8 hours to day 40 with taper to day 96.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Fludarabine Phosphate: Given IV~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant~Total-Body Irradation"
118510|NCT01894477|P1|Participant Flow|Arm A (Treosulfan, Fludarabine Phosphate)|"CONDITIONING REGIMEN:~Treosulfan IV over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2.~TRANSPLANT: Patients in both arms undergo allogeneic PBSC transplant or bone marrow transplant on day 0.~GVHD PROPHYLAXIS: Patients with related donor receive tacrolimus PO every 8 or 12 hours on days -3 to 56 with taper to day 180. Beginning 4-6 hours after PBSC infusion, and mycophenolate mofetil PO every 12 hours to day 28. Patients with an unrelated donor receive tacrolimus PO every 8 or 12 hours on days -3 to 100 with taper to day 180. Beginning 4-6 hours after PBSC infusion, and mycophenolate mofetil PO every 8 hours to day 40 with taper to day 96.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC"
118511|NCT01894477|O2|Outcome|Arm B (Treosulfan, Fludarabine Phosphate, TBI)|Treosulfan and fludarabine phosphate as in Arm A and undergo low-dose TBI on day 0.
118512|NCT01894477|O1|Outcome|Arm A (Treosulfan, Fludarabine Phosphate)|Treosulfan IV over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
118513|NCT01894477|O2|Outcome|Arm B (Treosulfan, Fludarabine Phosphate, TBI)|Treosulfan and fludarabine phosphate as in Arm A and undergo low-dose TBI on day 0.
118514|NCT01894477|O1|Outcome|Arm A (Treosulfan, Fludarabine Phosphate)|Treosulfan IV over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
118515|NCT01894477|E2|Reported Event|Arm B (Treosulfan, Fludarabine Phosphate, TBI)|Treosulfan and fludarabine phosphate as in Arm A and undergo low-dose TBI on day 0.
118516|NCT01894477|E1|Reported Event|Arm A (Treosulfan, Fludarabine Phosphate)|Treosulfan IV over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
118517|NCT01894256|B4|Baseline|Total|Total of all reporting groups
118518|NCT01894256|B3|Baseline|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118862|NCT01892306|O2|Outcome|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy~Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
118521|NCT01894256|P3|Participant Flow|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118522|NCT01894256|P2|Participant Flow|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118523|NCT01894256|P1|Participant Flow|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
118524|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118525|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118526|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
118527|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118528|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118529|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
118530|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118531|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118532|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
118533|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118534|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118535|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
118536|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118537|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118538|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
118539|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118540|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118899|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
118542|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118543|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118544|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
118545|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118546|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118547|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
118548|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118549|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118550|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
118551|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118552|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118553|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
118554|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118555|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118556|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
118557|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118558|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118559|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
118560|NCT01894256|E6|Reported Event|Part B Moderate Renal Impairment|"Patient in Part B of the study with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118561|NCT01894256|E5|Reported Event|Part B Mild Renal Impairment|"Patient in Part B of the study with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118900|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
118562|NCT01894256|E4|Reported Event|Part B Normal Renal Function|Patients in Part B of the study with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
118563|NCT01894256|E3|Reported Event|Part A Moderate Renal Impairment|"Patients in Part A of the study with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118564|NCT01894256|E2|Reported Event|Part A Mild Renal Impairment|"Patients in Part A of the study with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
118565|NCT01894256|E1|Reported Event|Part A Normal Renal Function|Patients from Part A of the study with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
118566|NCT01894230|B3|Baseline|Total|Total of all reporting groups
118567|NCT01894230|B2|Baseline|Usual Care Only|"Genetic testing for SLCO1B1*5 allele~Reporting for SLCO1B1*5 allele at the end of study~Reporting for SLCO1B1*5 allele at the end: Usual care recommendations provided to patient and provider at randomization. Genotyping results provided at the end of study.~Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele"
118568|NCT01894230|B1|Baseline|Genotype Results Plus Usual Care|"Genetic testing for SLCO1B1*5 allele~Reporting for SLCO1B1*5 allele at randomization~Reporting for SLCO1B1*5 allele at randomization: Reporting of genetic test results to patient and provider at randomization~Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele"
118569|NCT01894230|P2|Participant Flow|Usual Care Only|"Genetic testing for SLCO1B1*5 allele~Reporting for SLCO1B1*5 allele at the end of study~Reporting for SLCO1B1*5 allele at the end: Usual care recommendations provided to patient and provider at randomization. Genotyping results provided at the end of study.~Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele"
118570|NCT01894230|P1|Participant Flow|Genotype Results Plus Usual Care|"Genetic testing for SLCO1B1*5 allele~Reporting for SLCO1B1*5 allele at randomization~Reporting for SLCO1B1*5 allele at randomization: Reporting of genetic test results to patient and provider at randomization~Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele"
118571|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
118572|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
118573|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
118574|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
118575|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
118576|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
118577|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
118578|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
118579|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
118580|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
118581|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
118582|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
118583|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
118584|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
118585|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
118586|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
118587|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
118588|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
118589|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
118590|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
118591|NCT01894230|E2|Reported Event|Usual Care Only|"Genetic testing for SLCO1B1*5 allele~Reporting for SLCO1B1*5 allele at the end of study~Reporting for SLCO1B1*5 allele at the end: Usual care recommendations provided to patient and provider at randomization. Genotyping results provided at the end of study.~Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele"
118592|NCT01894230|E1|Reported Event|Genotype Results Plus Usual Care|"Genetic testing for SLCO1B1*5 allele~Reporting for SLCO1B1*5 allele at randomization~Reporting for SLCO1B1*5 allele at randomization: Reporting of genetic test results to patient and provider at randomization~Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele"
118593|NCT01894100|B3|Baseline|Total|Total of all reporting groups
118630|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
120401|NCT01884545|O4|Outcome|Non-Genetic Risk Counseling|Patients who did not receive genetic risk counseling
118594|NCT01894100|B2|Baseline|Immediate Intervention Group|"At baseline, participants in this group will begin shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
118595|NCT01894100|B1|Baseline|Delayed Intervention Group|"This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
118596|NCT01894100|P2|Participant Flow|Immediate Intervention Group|"At baseline, participants in this group will begin shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
118597|NCT01894100|P1|Participant Flow|Delayed Intervention Group|"This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
118598|NCT01894100|O2|Outcome|Immediate Intervention Group|"At baseline, participants in this group will begin shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
118599|NCT01894100|O1|Outcome|Delayed Intervention Group|"This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
118600|NCT01894100|O2|Outcome|Immediate Intervention Group|"At baseline, participants in this group will begin shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
118612|NCT01894087|O1|Outcome|Therapist-led Brief Intervention With Enhanced Usual Care|"Participants will receive a therapist-led, computer-assisted intervention session with a master's level therapist. The interventions are designed to address extramedical prescription opioid use and overdose risk behaviors. This includes a review of the participants' strengths, values, and goals; feedback regarding their opioid use and overdose risk behaviors; developing a discrepancy between their opioid and other drug use and ability to meet goals and values; and the formulation of a change plan for each participant. Participants in this condition also received the brochures given for the Enhanced Usual Care protocol."
118678|NCT01893905|P1|Participant Flow|CS+SG|Chondroitin sulfate+ glucosamine sulfate
118601|NCT01894100|O1|Outcome|Delayed Intervention Group|"This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
118602|NCT01894100|E2|Reported Event|Immediate Intervention Group|"At baseline, participants in this group will begin shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
118603|NCT01894100|E1|Reported Event|Delayed Intervention Group|"This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
118604|NCT01894087|B3|Baseline|Total|Total of all reporting groups
118605|NCT01894087|B2|Baseline|Enhanced Usual Care Only|For Enhanced Usual Care (EUC), therapists provided two brochures: (1) an overdose prevention and response brochure, and (2) a resource brochure. The overdose prevention and response brochure included a definition of overdose, signs and symptoms, risk factors, and bystander response to overdose. The resource brochure contained information on drug,mental health and alcohol treatment, mutual help groups, local resources for obtaining naloxone, free health clinics in the area, and a suicide prevention hotline.
118606|NCT01894087|B1|Baseline|Therapist-led Brief Intervention With Enhanced Usual Care|"Participants will receive a therapist-led, computer-assisted intervention session with a master's level therapist. The interventions are designed to address extramedical prescription opioid use and overdose risk behaviors. This includes a review of the participants' strengths, values, and goals; feedback regarding their opioid use and overdose risk behaviors; developing a discrepancy between their opioid and other drug use and ability to meet goals and values; and the formulation of a change plan for each participant. Participants in this condition also received the brochures given for the Enhanced Usual Care protocol."
118607|NCT01894087|P2|Participant Flow|Enhanced Usual Care Only|For Enhanced Usual Care (EUC), therapists provided two brochures: (1) an overdose prevention and response brochure, and (2) a resource brochure. The overdose prevention and response brochure included a definition of overdose, signs and symptoms, risk factors, and bystander response to overdose. The resource brochure contained information on drug,mental health and alcohol treatment, mutual help groups, local resources for obtaining naloxone, free health clinics in the area, and a suicide prevention hotline.
118608|NCT01894087|P1|Participant Flow|Therapist-led Brief Intervention With Enhanced Usual Care|"Participants will receive a therapist-led, computer-assisted intervention session with a master's level therapist. The interventions are designed to address extramedical prescription opioid use and overdose risk behaviors. This includes a review of the participants' strengths, values, and goals; feedback regarding their opioid use and overdose risk behaviors; developing a discrepancy between their opioid and other drug use and ability to meet goals and values; and the formulation of a change plan for each participant. Participants in this condition also received the brochures given for the Enhanced Usual Care protocol."
118609|NCT01894087|O2|Outcome|Enhanced Usual Care Only|For Enhanced Usual Care (EUC), therapists provided two brochures: (1) an overdose prevention and response brochure, and (2) a resource brochure. The overdose prevention and response brochure included a definition of overdose, signs and symptoms, risk factors, and bystander response to overdose. The resource brochure contained information on drug,mental health and alcohol treatment, mutual help groups, local resources for obtaining naloxone, free health clinics in the area, and a suicide prevention hotline.
118610|NCT01894087|O1|Outcome|Therapist-led Brief Intervention With Enhanced Usual Care|"Participants will receive a therapist-led, computer-assisted intervention session with a master's level therapist. The interventions are designed to address extramedical prescription opioid use and overdose risk behaviors. This includes a review of the participants' strengths, values, and goals; feedback regarding their opioid use and overdose risk behaviors; developing a discrepancy between their opioid and other drug use and ability to meet goals and values; and the formulation of a change plan for each participant. Participants in this condition also received the brochures given for the Enhanced Usual Care protocol."
118611|NCT01894087|O2|Outcome|Enhanced Usual Care Only|For Enhanced Usual Care (EUC), therapists provided two brochures: (1) an overdose prevention and response brochure, and (2) a resource brochure. The overdose prevention and response brochure included a definition of overdose, signs and symptoms, risk factors, and bystander response to overdose. The resource brochure contained information on drug,mental health and alcohol treatment, mutual help groups, local resources for obtaining naloxone, free health clinics in the area, and a suicide prevention hotline.
118679|NCT01893905|O2|Outcome|Placebo|Placebo Oral
118680|NCT01893905|O1|Outcome|CS+SG|Chondroitin sulfate+glucosamine sulfate
118613|NCT01894087|O2|Outcome|Enhanced Usual Care Only|For Enhanced Usual Care (EUC), therapists provided two brochures: (1) an overdose prevention and response brochure, and (2) a resource brochure. The overdose prevention and response brochure included a definition of overdose, signs and symptoms, risk factors, and bystander response to overdose. The resource brochure contained information on drug,mental health and alcohol treatment, mutual help groups, local resources for obtaining naloxone, free health clinics in the area, and a suicide prevention hotline.
118614|NCT01894087|O1|Outcome|Therapist-led Brief Intervention With Enhanced Usual Care|"Participants will receive a therapist-led, computer-assisted intervention session with a master's level therapist. The interventions are designed to address extramedical prescription opioid use and overdose risk behaviors. This includes a review of the participants' strengths, values, and goals; feedback regarding their opioid use and overdose risk behaviors; developing a discrepancy between their opioid and other drug use and ability to meet goals and values; and the formulation of a change plan for each participant. Participants in this condition also received the brochures given for the Enhanced Usual Care protocol."
118615|NCT01894087|O2|Outcome|Enhanced Usual Care Only|For Enhanced Usual Care (EUC), therapists provided two brochures: (1) an overdose prevention and response brochure, and (2) a resource brochure. The overdose prevention and response brochure included a definition of overdose, signs and symptoms, risk factors, and bystander response to overdose. The resource brochure contained information on drug,mental health and alcohol treatment, mutual help groups, local resources for obtaining naloxone, free health clinics in the area, and a suicide prevention hotline.
118616|NCT01894087|O1|Outcome|Therapist-led Brief Intervention With Enhanced Usual Care|"Participants will receive a therapist-led, computer-assisted intervention session with a master's level therapist. The interventions are designed to address extramedical prescription opioid use and overdose risk behaviors. This includes a review of the participants' strengths, values, and goals; feedback regarding their opioid use and overdose risk behaviors; developing a discrepancy between their opioid and other drug use and ability to meet goals and values; and the formulation of a change plan for each participant. Participants in this condition also received the brochures given for the Enhanced Usual Care protocol."
118617|NCT01894087|E2|Reported Event|Enhanced Usual Care Only|For Enhanced Usual Care (EUC), therapists provided two brochures: (1) an overdose prevention and response brochure, and (2) a resource brochure. The overdose prevention and response brochure included a definition of overdose, signs and symptoms, risk factors, and bystander response to overdose. The resource brochure contained information on drug,mental health and alcohol treatment, mutual help groups, local resources for obtaining naloxone, free health clinics in the area, and a suicide prevention hotline.
118618|NCT01894087|E1|Reported Event|Therapist-led Brief Intervention With Enhanced Usual Care|"Participants will receive a therapist-led, computer-assisted intervention session with a master's level therapist. The interventions are designed to address extramedical prescription opioid use and overdose risk behaviors. This includes a review of the participants' strengths, values, and goals; feedback regarding their opioid use and overdose risk behaviors; developing a discrepancy between their opioid and other drug use and ability to meet goals and values; and the formulation of a change plan for each participant. Participants in this condition also received the brochures given for the Enhanced Usual Care protocol."
118619|NCT01894022|B3|Baseline|Total|Total of all reporting groups
118620|NCT01894022|B2|Baseline|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118621|NCT01894022|B1|Baseline|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118622|NCT01894022|P2|Participant Flow|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118623|NCT01894022|P1|Participant Flow|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118624|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118625|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118626|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118627|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118628|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118629|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118681|NCT01893905|E2|Reported Event|Placebo|Placebo oral
118682|NCT01893905|E1|Reported Event|CS+SG|chondroitin sulfate+glucosamine sulfate
118683|NCT01893879|B3|Baseline|Total|Total of all reporting groups
118631|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118632|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118633|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118634|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118635|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118636|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118637|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118638|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118639|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118640|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118641|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118642|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118643|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118644|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118645|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118646|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118647|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118648|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118649|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118650|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118651|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118652|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118653|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118654|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118655|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118656|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118657|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118658|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118659|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118660|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118661|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118662|NCT01894022|O2|Outcome|Ambrisentan 5 mg|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118663|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118664|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118665|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118666|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118667|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118668|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118669|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118670|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118671|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118672|NCT01894022|E2|Reported Event|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118673|NCT01894022|E1|Reported Event|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
118674|NCT01893905|B3|Baseline|Total|Total of all reporting groups
118675|NCT01893905|B2|Baseline|Placebo|Placebo oral
118676|NCT01893905|B1|Baseline|CS+SG|Chondroitin sulfate+glucosamine sulfate
118677|NCT01893905|P2|Participant Flow|Placebo|Oral Placebo
118685|NCT01893879|B1|Baseline|(RS)2-(3-benzoylphenyl)-Propionic Acid|"Patients receive study drug three times daily, orally, for up to 1 year in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis will be performed.~(RS)2-(3-benzoylphenyl)-propionic acid: Given PO~laboratory biomarker analysis: Correlative studies"
118686|NCT01893879|P2|Participant Flow|Placebo for Study Drug|"Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis will be performed.~placebo for study drug: Given PO~laboratory biomarker analysis: Correlative studies"
118687|NCT01893879|P1|Participant Flow|(RS)2-(3-benzoylphenyl)-Propionic Acid|"Patients receive study drug PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis will be performed.~(RS)2-(3-benzoylphenyl)-propionic acid: Given PO~laboratory biomarker analysis: Correlative studies"
118688|NCT01893879|O2|Outcome|Placebo for Study Drug|"Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis will be performed.~placebo for study drug: Given PO~laboratory biomarker analysis: Correlative studies"
118689|NCT01893879|O1|Outcome|(RS)2-(3-benzoylphenyl)-Propionic Acid|"Patients receive study drug PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis will be performed.~(RS)2-(3-benzoylphenyl)-propionic acid: Given PO~laboratory biomarker analysis: Correlative studies"
118690|NCT01893879|E2|Reported Event|Placebo for Study Drug|"Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis will be performed.~placebo for study drug: Given PO~laboratory biomarker analysis: Correlative studies"
118691|NCT01893879|E1|Reported Event|(RS)2-(3-benzoylphenyl)-Propionic Acid|"Patients receive study drug PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis will be performed.~(RS)2-(3-benzoylphenyl)-propionic acid: Given PO~laboratory biomarker analysis: Correlative studies"
118692|NCT01893567|B1|Baseline|Clobex Spray|Clobex Spray
118693|NCT01893567|P1|Participant Flow|Clobex Spray|Clobex Spray
118694|NCT01893567|O1|Outcome|Clobex Spray|Clobex Spray
118695|NCT01893567|E1|Reported Event|Clobex Spray|Clobex Spray
118696|NCT01893411|B4|Baseline|Total|Total of all reporting groups
118697|NCT01893411|B3|Baseline|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
118698|NCT01893411|B2|Baseline|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
118699|NCT01893411|B1|Baseline|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
118700|NCT01893411|P3|Participant Flow|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
118701|NCT01893411|P2|Participant Flow|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
118702|NCT01893411|P1|Participant Flow|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 Unit per kilogram (U/kg) Body Weight (BW) of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
118703|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
118704|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
118705|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
118706|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
118707|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
118708|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
118709|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
118710|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
118711|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
118712|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
118713|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
118901|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
118714|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
118715|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
118716|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
118717|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
118718|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
118719|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
118720|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
118721|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
118722|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
118723|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
118724|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
118725|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
118726|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
118727|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
118728|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
118729|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
118730|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
118731|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
118732|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
118733|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
118734|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
118735|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
118736|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
118737|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
118738|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
118739|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
118740|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
118902|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
118741|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
118742|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
118743|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
118744|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
118745|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
118746|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
118747|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
118748|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
118749|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
118750|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
118751|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
118752|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
118753|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
118754|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
118755|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
118756|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
118757|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
118758|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
118759|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
118760|NCT01893411|E3|Reported Event|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 U per injection treatment via intramuscular injection into spastic muscles.
118761|NCT01893411|E2|Reported Event|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 U per injection treatment via intramuscular injection into spastic muscles.
118762|NCT01893411|E1|Reported Event|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 Unit per kilogram (U/kg) Body Weight (BW) of IncobotulinumtoxinA (Xeomin) with a maximum of 400 U per injection treatment via intramuscular injection into spastic muscles.
118763|NCT01893359|B4|Baseline|Total|Total of all reporting groups
118764|NCT01893359|B3|Baseline|LASIK Only|"Eyes assigned to this arm will receive standard LASIK with no cross-linking.~Laser-assisted in situ keratomileusis"
118765|NCT01893359|B2|Baseline|LASIK Followed by Cross-linking (Pulsed)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)~Laser-assisted in situ keratomileusis"
118766|NCT01893359|B1|Baseline|LASIK Followed by Cross-linking (Continuous Wave)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)~Laser-assisted in situ keratomileusis"
118767|NCT01893359|P3|Participant Flow|LASIK Only|"Eyes assigned to this arm will receive standard LASIK with no cross-linking.~Laser-assisted in situ keratomileusis"
120402|NCT01884545|O3|Outcome|Genetic Risk Counseling|Patients who received genetic risk counseling
118768|NCT01893359|P2|Participant Flow|LASIK Followed by Cross-linking (Pulsed)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)~Laser-assisted in situ keratomileusis"
118769|NCT01893359|P1|Participant Flow|LASIK Followed by Cross-linking (Continuous Wave)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)~Laser-assisted in situ keratomileusis"
118770|NCT01893359|O3|Outcome|LASIK Only|"Eyes assigned to this arm will receive standard LASIK with no cross-linking.~Laser-assisted in situ keratomileusis"
118771|NCT01893359|O2|Outcome|LASIK Followed by Cross-linking (Pulsed)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)~Laser-assisted in situ keratomileusis"
118772|NCT01893359|O1|Outcome|LASIK Followed by Cross-linking (Continuous Wave)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)~Laser-assisted in situ keratomileusis"
118773|NCT01893359|O3|Outcome|LASIK Only|"Eyes assigned to this arm will receive standard LASIK with no cross-linking.~Laser-assisted in situ keratomileusis"
118774|NCT01893359|O2|Outcome|LASIK Followed by Cross-linking (Pulsed)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)~Laser-assisted in situ keratomileusis"
118775|NCT01893359|O1|Outcome|LASIK Followed by Cross-linking (Continuous Wave)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)~Laser-assisted in situ keratomileusis"
118776|NCT01893359|E3|Reported Event|LASIK Only|"Eyes assigned to this arm will receive standard LASIK with no cross-linking.~Laser-assisted in situ keratomileusis"
118777|NCT01893359|E2|Reported Event|LASIK Followed by Cross-linking (Pulsed)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)~Laser-assisted in situ keratomileusis"
118778|NCT01893359|E1|Reported Event|LASIK Followed by Cross-linking (Continuous Wave)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)~Laser-assisted in situ keratomileusis"
118779|NCT01893346|B5|Baseline|Total|Total of all reporting groups
118780|NCT01893346|B4|Baseline|Cohort 4|"aged ≥3 months to <2 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.~Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
118781|NCT01893346|B3|Baseline|Cohort 3|"aged ≥2 to <6 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.~Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
118782|NCT01893346|B2|Baseline|Cohort 2|aged ≥6 to <12 years Weight <40 kg: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam Weight ≥40 kg: 2000 mg ceftazidime and 500 mg avibactam
118783|NCT01893346|B1|Baseline|Cohort 1|aged ≥12 to <18 years 2000 mg ceftazidime and 500 mg avibactam
118784|NCT01893346|P4|Participant Flow|Cohort 4|"aged ≥3 months to <2 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.~Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
118785|NCT01893346|P3|Participant Flow|Cohort 3|"aged ≥2 to <6 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.~Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
118786|NCT01893346|P2|Participant Flow|Cohort 2|aged ≥6 to <12 years Weight <40 kg: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam Weight ≥40 kg: 2000 mg ceftazidime and 500 mg avibactam
118787|NCT01893346|P1|Participant Flow|Cohort 1|aged ≥12 to <18 years 2000 mg ceftazidime and 500 mg avibactam
118788|NCT01893346|O4|Outcome|Cohort 2 / Ceftazidime|aged ≥6 to <12 years
118789|NCT01893346|O3|Outcome|Cohort 2 / Avibactam|aged ≥6 to <12 years
118790|NCT01893346|O2|Outcome|Cohort 1 / Ceftazidime|aged ≥12 to <18 years / Ceftazidime
118791|NCT01893346|O1|Outcome|Cohort 1 / Avibactam|aged ≥12 to <18 years
118792|NCT01893346|O4|Outcome|Cohort 2 / Ceftazidime|aged ≥6 to <12 years
118793|NCT01893346|O3|Outcome|Cohort 2 / Avibactam|aged ≥6 to <12 years
118794|NCT01893346|O2|Outcome|Cohort 1 / Ceftazidime|aged ≥12 to <18 years / Ceftazidime
118795|NCT01893346|O1|Outcome|Cohort 1 / Avibactam|aged ≥12 to <18 years
118796|NCT01893346|E4|Reported Event|Cohort 4|"aged ≥3 months to <2 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.~Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
120403|NCT01884545|O2|Outcome|Non-Health Coaching|Participants who did not receive health coaching
118797|NCT01893346|E3|Reported Event|Cohort 3|"aged ≥2 to <6 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.~Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
118798|NCT01893346|E2|Reported Event|Cohort 2|aged ≥6 to <12 years Weight <40 kg: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam Weight ≥40 kg: 2000 mg ceftazidime and 500 mg avibactam
118799|NCT01893346|E1|Reported Event|Cohort 1|aged ≥12 to <18 years 2000 mg ceftazidime and 500 mg avibactam
118800|NCT01893281|B1|Baseline|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
118801|NCT01893281|P1|Participant Flow|Topical Testosterone Solution|Testosterone, initially 60 milligrams (mg) once daily (QD), titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
118802|NCT01893281|O1|Outcome|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
118803|NCT01893281|O1|Outcome|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
118804|NCT01893281|O1|Outcome|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
118805|NCT01893281|O1|Outcome|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
118806|NCT01893281|E1|Reported Event|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
118807|NCT01893203|B1|Baseline|BF-200 ALA vs MAL|BF-200 ALA cream and MAL (Metvix, Galderma) used in a randomized split-face design
118808|NCT01893203|P1|Participant Flow|BF200 ALA vs MAL|5-aminulevulinic acid nanoemulsion (BF-200 ALA, Ameluz, Biofrontera) and methylaminolevulinic acid (MAL, Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
118809|NCT01893203|O1|Outcome|BF200 ALA vs MAL|BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
118810|NCT01893203|O1|Outcome|BF200 ALA vs MAL|BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
118811|NCT01893203|O1|Outcome|BF200 ALA vs MAL|BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
118812|NCT01893203|O1|Outcome|BF200 ALA vs MAL|BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
118813|NCT01893203|E1|Reported Event|BF200 ALA vs MAL|BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized slipt face design on symmetrical treatment areas.
118814|NCT01892865|B3|Baseline|Total|Total of all reporting groups
118815|NCT01892865|B2|Baseline|Predictive Modeling System (PMS)|Scheduling using regression modeling system: A regression model that uses predictor of operative length will be used to predict operative, anesthetic, and turn around time length
118816|NCT01892865|B1|Baseline|Historical Means Method|Scheduling using historical means: Scheduling will be performed taking into account historical means only for anesthetic, operative, and turn around time
118817|NCT01892865|P2|Participant Flow|Predictive Modeling System (PMS)|Scheduling using regression modeling system: A regression model that uses predictor of operative length will be used to predict operative, anesthetic, and turn around time length
118818|NCT01892865|P1|Participant Flow|Historical Means Method|Scheduling using historical means: Scheduling will be performed taking into account historical means only for anesthetic, operative, and turn around time
118819|NCT01892865|O2|Outcome|Predictive Modeling System (PMS)|Scheduling using regression modeling system: A regression model that uses predictor of operative length will be used to predict operative, anesthetic, and turn around time length
118820|NCT01892865|O1|Outcome|Historical Means Method|Scheduling using historical means: Scheduling will be performed taking into account historical means only for anesthetic, operative, and turn around time
118821|NCT01892865|O2|Outcome|Predictive Modeling System (PMS)|Scheduling using regression modeling system: A regression model that uses predictor of operative length will be used to predict operative, anesthetic, and turn around time length
118822|NCT01892865|O1|Outcome|Historical Means Method|Scheduling using historical means: Scheduling will be performed taking into account historical means only for anesthetic, operative, and turn around time
118823|NCT01892865|O2|Outcome|Predictive Modeling System (PMS)|Scheduling using regression modeling system: A regression model that uses predictor of operative length will be used to predict operative, anesthetic, and turn around time length
118824|NCT01892865|O1|Outcome|Historical Means Method|Scheduling using historical means: Scheduling will be performed taking into account historical means only for anesthetic, operative, and turn around time
118825|NCT01892865|O2|Outcome|Predictive Modeling System (PMS)|Scheduling using regression modeling system: A regression model that uses predictor of operative length will be used to predict operative, anesthetic, and turn around time length
118826|NCT01892865|O1|Outcome|Historical Means Method|Scheduling using historical means: Scheduling will be performed taking into account historical means only for anesthetic, operative, and turn around time
118827|NCT01892865|E2|Reported Event|Predictive Modeling System (PMS)|Scheduling using regression modeling system: A regression model that uses predictor of operative length will be used to predict operative, anesthetic, and turn around time length
118828|NCT01892865|E1|Reported Event|Historical Means Method|Scheduling using historical means: Scheduling will be performed taking into account historical means only for anesthetic, operative, and turn around time
118829|NCT01892709|B1|Baseline|Hydromorphone|"All eligible patients will receive 1 mg IV hydromorphone. Thereafter, they will be repeatedly asked the question, Do you want more pain medicine? This question will be asked 30 minutes after they answered no or 30 minutes after the completion of the next dose of 1 mg IV hydromorphone, which occurs when the patients answers yes. Patients will receive a maximum of 4 mg IV hydromorphone over a 4 hour period.~Hydromorphone"
120404|NCT01884545|O1|Outcome|Health Coaching|Participants who received health coaching
118830|NCT01892709|P1|Participant Flow|Hydromorphone|"All eligible patients will receive 1 mg IV hydromorphone. Thereafter, they will be repeatedly asked the question, Do you want more pain medicine? This question will be asked 30 minutes after they answered no or 30 minutes after the completion of the next dose of 1 mg IV hydromorphone, which occurs when the patients answers yes. Patients will receive a maximum of 4 mg IV hydromorphone over a 4 hour period.~Hydromorphone"
118831|NCT01892709|O1|Outcome|Hydromorphone|"All eligible patients will receive 1 mg IV hydromorphone. Thereafter, they will be repeatedly asked the question, Do you want more pain medicine? This question will be asked 30 minutes after they answered no or 30 minutes after the completion of the next dose of 1 mg IV hydromorphone, which occurs when the patients answers yes. Patients will receive a maximum of 4 mg IV hydromorphone over a 4 hour period.~Hydromorphone"
118832|NCT01892709|O1|Outcome|Hydromorphone|"All eligible patients will receive 1 mg IV hydromorphone. Thereafter, they will be repeatedly asked the question, Do you want more pain medicine? This question will be asked 30 minutes after they answered no or 30 minutes after the completion of the next dose of 1 mg IV hydromorphone, which occurs when the patients answers yes. Patients will receive a maximum of 4 mg IV hydromorphone over a 4 hour period.~Hydromorphone"
118833|NCT01892709|O4|Outcome|4 mg Hydromorphone|Received 4 mg of IV hydromorphone, in 4 1-mg doses
118834|NCT01892709|O3|Outcome|3 mg Hydromorphone|Received 3 mg of IV hydromorphone, in 3 1-mg doses
118835|NCT01892709|O2|Outcome|2 mg Hydromorphone|Received 2 mg of IV hydromorphone, in 2 1-mg doses.
118836|NCT01892709|O1|Outcome|1 mg Hydromorphone|"Received 1 mg of IV hydromorphone, and answered no to all repeated questions of Do you want more pain medication?"
118837|NCT01892709|O1|Outcome|Hydromorphone|"All eligible patients will receive 1 mg IV hydromorphone. Thereafter, they will be repeatedly asked the question, Do you want more pain medicine? This question will be asked 30 minutes after they answered no or 30 minutes after the completion of the next dose of 1 mg IV hydromorphone, which occurs when the patients answers yes. Patients will receive a maximum of 4 mg IV hydromorphone over a 4 hour period.~Hydromorphone"
118838|NCT01892709|E1|Reported Event|Hydromorphone|"All eligible patients will receive 1 mg IV hydromorphone. Thereafter, they will be repeatedly asked the question, Do you want more pain medicine? This question will be asked 30 minutes after they answered no or 30 minutes after the completion of the next dose of 1 mg IV hydromorphone, which occurs when the patients answers yes. Patients will receive a maximum of 4 mg IV hydromorphone over a 4 hour period.~Hydromorphone"
118839|NCT01892657|B1|Baseline|Facial Moisturizer With SPF 50+|All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+
118840|NCT01892657|P1|Participant Flow|Facial Moisturizer With SPF 50+|All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+
118841|NCT01892657|O13|Outcome|Challenge Patch (Alternate Site) - 96 Hours|A challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to an alternate application site was graded again at 96 hours.
118842|NCT01892657|O12|Outcome|Challenge Patch (Alternate Site) - 48 Hours|A challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to an alternate application site was graded at 48 hours.
118843|NCT01892657|O11|Outcome|Challenge Patch (Original Site) - 96 Hours|The challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to the original application site was graded again at 96 hours.
118844|NCT01892657|O10|Outcome|Challenge Patch (Original Site) - 48 Hours|The challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to the original application site was graded at 48 hours.
118845|NCT01892657|O9|Outcome|Patch 9|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
118846|NCT01892657|O8|Outcome|Patch 8|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
118847|NCT01892657|O7|Outcome|Patch 7|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
118848|NCT01892657|O6|Outcome|Patch 6|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
118849|NCT01892657|O5|Outcome|Patch 5|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
118850|NCT01892657|O4|Outcome|Patch 4|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
118851|NCT01892657|O3|Outcome|Patch 3|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
118852|NCT01892657|O2|Outcome|Patch 2|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
118853|NCT01892657|O1|Outcome|Patch 1|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
118854|NCT01892657|E1|Reported Event|Facial Moisturizer With SPF 50+|All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+
118855|NCT01892306|B3|Baseline|Total|Total of all reporting groups
118856|NCT01892306|B2|Baseline|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy~Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
118857|NCT01892306|B1|Baseline|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT~UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
118858|NCT01892306|P2|Participant Flow|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy~Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
118859|NCT01892306|P1|Participant Flow|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT~UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
118860|NCT01892306|O2|Outcome|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy~Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
118861|NCT01892306|O1|Outcome|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT~UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
118903|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
118863|NCT01892306|O1|Outcome|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT~UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
118864|NCT01892306|O2|Outcome|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy~Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
118865|NCT01892306|O1|Outcome|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT~UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
118866|NCT01892306|O2|Outcome|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy~Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
118867|NCT01892306|O1|Outcome|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT~UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
118868|NCT01892306|O2|Outcome|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy~Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
118869|NCT01892306|O1|Outcome|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT~UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
118870|NCT01892306|O2|Outcome|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy~Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
118871|NCT01892306|O1|Outcome|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT~UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
118872|NCT01892306|O2|Outcome|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy~Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
118873|NCT01892306|O1|Outcome|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT~UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
118874|NCT01892306|O2|Outcome|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy~Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
118875|NCT01892306|O1|Outcome|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT~UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
118876|NCT01892306|E2|Reported Event|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy~Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
118877|NCT01892306|E1|Reported Event|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT~UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
118878|NCT01892267|B3|Baseline|Total|Total of all reporting groups
118879|NCT01892267|B2|Baseline|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
118880|NCT01892267|B1|Baseline|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
118881|NCT01892267|P2|Participant Flow|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
118882|NCT01892267|P1|Participant Flow|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
118883|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
118884|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
118885|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
118886|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
118887|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
118888|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
118889|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
118890|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
118891|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
118892|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
118893|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
118894|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
118895|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
118896|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
118897|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
118898|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
120405|NCT01884545|O4|Outcome|Non-Genetic Risk Counseling|Patients who did not receive genetic risk counseling
118905|NCT01892267|E2|Reported Event|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
118906|NCT01892267|E1|Reported Event|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
118907|NCT01892189|B10|Baseline|Total|Total of all reporting groups
118908|NCT01892189|B9|Baseline|TAK-063 300 mg/10 mg + Placebo + TAK-063 30 mg|TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), , tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
118909|NCT01892189|B8|Baseline|TAK-063 30 mg + TAK-063 300 mg/10 mg + Placebo|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
118910|NCT01892189|B7|Baseline|Placebo + TAK-063 30 mg + TAK-063 300 mg/10 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
118911|NCT01892189|B6|Baseline|TAK-063 300 mg/10 mg + Placebo + TAK-063 3 mg|TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
118912|NCT01892189|B5|Baseline|TAK-063 3 mg + TAK-063 300 mg/10 mg + Placebo|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
118913|NCT01892189|B4|Baseline|Placebo + TAK-063 3 mg + TAK-063 300 mg/10 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
118914|NCT01892189|B3|Baseline|TAK-063 30 mg + Placebo + TAK-063 3 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
118915|NCT01892189|B2|Baseline|TAK-063 3 mg + TAK-063 30 mg + Placebo|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
118916|NCT01892189|B1|Baseline|Placebo + TAK-063 3 mg + TAK-063 30 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
118917|NCT01892189|P9|Participant Flow|TAK-063 300 mg/10 mg + Placebo + TAK-063 30 mg|TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), , tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
118940|NCT01892189|O1|Outcome|Placebo|TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
118941|NCT01892189|O5|Outcome|TAK-063 300 mg|TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
118942|NCT01892189|O4|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
118918|NCT01892189|P8|Participant Flow|TAK-063 30 mg + TAK-063 300 mg/10 mg + Placebo|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
118919|NCT01892189|P7|Participant Flow|Placebo + TAK-063 30 mg + TAK-063 300 mg/10 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
118920|NCT01892189|P6|Participant Flow|TAK-063 300 mg/10 mg + Placebo + TAK-063 3 mg|TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
118921|NCT01892189|P5|Participant Flow|TAK-063 3 mg + TAK-063 300 mg/10 mg + Placebo|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
118922|NCT01892189|P4|Participant Flow|Placebo + TAK-063 3 mg + TAK-063 300 mg/10 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
118923|NCT01892189|P3|Participant Flow|TAK-063 30 mg + Placebo + TAK-063 3 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
118924|NCT01892189|P2|Participant Flow|TAK-063 3 mg + TAK-063 30 mg + Placebo|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
118925|NCT01892189|P1|Participant Flow|Placebo + TAK-063 3 mg + TAK-063 30 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
118926|NCT01892189|O5|Outcome|TAK-063 300 mg|TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
118927|NCT01892189|O4|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
118928|NCT01892189|O3|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
118929|NCT01892189|O2|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
118930|NCT01892189|O1|Outcome|Placebo|TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
118931|NCT01892189|O5|Outcome|TAK-063 300 mg|TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
118932|NCT01892189|O4|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
118933|NCT01892189|O3|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
118934|NCT01892189|O2|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
118935|NCT01892189|O1|Outcome|Placebo|TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
118936|NCT01892189|O5|Outcome|TAK-063 300 mg|TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
118937|NCT01892189|O4|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
118938|NCT01892189|O3|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
118943|NCT01892189|O3|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
118944|NCT01892189|O2|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
118945|NCT01892189|O1|Outcome|Placebo|TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
118946|NCT01892189|O3|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
118947|NCT01892189|O2|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
118948|NCT01892189|O1|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
118949|NCT01892189|O3|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
118950|NCT01892189|O2|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
118951|NCT01892189|O1|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
118952|NCT01892189|O3|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
118953|NCT01892189|O2|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
118954|NCT01892189|O1|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
118955|NCT01892189|O4|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
118956|NCT01892189|O3|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
118957|NCT01892189|O2|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
118958|NCT01892189|O1|Outcome|Placebo|TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
118959|NCT01892189|E5|Reported Event|TAK-063 300 mg|TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
118960|NCT01892189|E4|Reported Event|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
118961|NCT01892189|E3|Reported Event|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
118962|NCT01892189|E2|Reported Event|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
118963|NCT01892189|E1|Reported Event|Placebo|TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
118964|NCT01892163|B3|Baseline|Total|Total of all reporting groups
118965|NCT01892163|B2|Baseline|Ozurdex Fixed Dosing|Ozurdex: Dexamethasone implant (Ozurdex)
118966|NCT01892163|B1|Baseline|Ozurdex PRN Dosing|"Ozurdex PRN dosing versus Ozurdex fixed dosing~Ozurdex: Dexamethasone implant (Ozurdex)"
118967|NCT01892163|P2|Participant Flow|Ozurdex Fixed Dosing|Ozurdex: Dexamethasone implant (Ozurdex)
118968|NCT01892163|P1|Participant Flow|Ozurdex PRN Dosing|"Ozurdex PRN dosing versus Ozurdex fixed dosing~Ozurdex: Dexamethasone implant (Ozurdex)"
118969|NCT01892163|O2|Outcome|Ozurdex Fixed Dosing|Ozurdex: Dexamethasone implant (Ozurdex)
118970|NCT01892163|O1|Outcome|Ozurdex PRN Dosing|"Ozurdex PRN dosing versus Ozurdex fixed dosing~Ozurdex: Dexamethasone implant (Ozurdex)"
118971|NCT01892163|O2|Outcome|Ozurdex Fixed Dosing|Ozurdex: Dexamethasone implant (Ozurdex)
118972|NCT01892163|O1|Outcome|Ozurdex PRN Dosing|"Ozurdex PRN dosing versus Ozurdex fixed dosing~Ozurdex: Dexamethasone implant (Ozurdex)"
118973|NCT01892163|O2|Outcome|Ozurdex Fixed Dosing|Ozurdex: Dexamethasone implant (Ozurdex)
118974|NCT01892163|O1|Outcome|Ozurdex PRN Dosing|"Ozurdex PRN dosing versus Ozurdex fixed dosing~Ozurdex: Dexamethasone implant (Ozurdex)"
118975|NCT01892163|O2|Outcome|Ozurdex Fixed Dosing|Ozurdex: Dexamethasone implant (Ozurdex)
118976|NCT01892163|O1|Outcome|Ozurdex PRN Dosing|"Ozurdex PRN dosing versus Ozurdex fixed dosing~Ozurdex: Dexamethasone implant (Ozurdex)"
118977|NCT01892163|E2|Reported Event|Ozurdex Fixed Dosing|Ozurdex: Dexamethasone implant (Ozurdex)
118978|NCT01892163|E1|Reported Event|Ozurdex PRN Dosing|"Ozurdex PRN dosing versus Ozurdex fixed dosing~Ozurdex: Dexamethasone implant (Ozurdex)"
118979|NCT01892020|B1|Baseline|All Subjects|In this multi-center, randomized, open-labelled, 2-sequence, 2-period crossover trial, the eligible subjects were randomized to 2 groups to receive biphasic insulin aspart 50 (BIAsp 50) and biphasic human insulin 50 (BHI 50) in different sequences. Group A received BIAsp 50 twice daily (BID) during the first 4 weeks (period 1), then switched to BHI 50 BID for further 4 weeks (period 2). Group B received BHI 50 BID during the first 4 weeks (period 1), then switched to BIAsp 50 BID for further 4 weeks (period 2). BIAsp 50 (NovoMix® 50) was administered subcutaneously (s.c.) using NovoPen 4 immediately before breakfast and dinner. And BHI 50 was administered s.c. using NovoPen 4 at least 30 minutes before breakfast and dinner. All subjects received metformin throughout this trial. Insulin dose was adjusted twice weekly based on self-measured plasma glucose (SMPG).
118980|NCT01892020|P2|Participant Flow|Group B (BHI 50 - BIAsp 50)|"In this multi-center, randomized, open-labelled, 2-sequence, 2-period crossover trial, the eligible subjects were randomized to 2 groups to receive biphasic insulin aspart 50 (BIAsp 50) and biphasic human insulin 50 (BHI 50) in different sequences.~Group B received BHI 50 twice daily (BID) during the first 4 weeks (period 1), then switched to BIAsp 50 BID for further 4 weeks (period 2). BIAsp 50 (NovoMix® 50) was administered subcutaneously (s.c.) using NovoPen 4 immediately before breakfast and dinner. And BHI 50 was administered s.c. using NovoPen 4 at least 30 minutes before breakfast and dinner. All subjects received metformin throughout this trial. Insulin dose was adjusted twice weekly based on self-measured plasma glucose (SMPG)."
120406|NCT01884545|O3|Outcome|Genetic Risk Counseling|Patients who received genetic risk counseling
118981|NCT01892020|P1|Participant Flow|Group A (BIAsp 50 - BHI 50)|"In this multi-center, randomized, open-labelled, 2-sequence, 2-period crossover trial, the eligible subjects were randomized to 2 groups to receive biphasic insulin aspart 50 (BIAsp 50) and biphasic human insulin 50 (BHI 50) in different sequences.~Group A received BIAsp 50 twice daily (BID) during the first 4 weeks (period 1), then switched to BHI 50 BID for further 4 weeks (period 2). BIAsp 50 (NovoMix® 50) was administered subcutaneously (s.c.) using NovoPen 4 immediately before breakfast and dinner. And BHI 50 was administered s.c. using NovoPen 4 at least 30 minutes before breakfast and dinner. All subjects received metformin throughout this trial. Insulin dose was adjusted twice weekly based on self-measured plasma glucose (SMPG)."
118982|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
118983|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
118984|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
118985|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
118986|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
118987|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
118988|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
118989|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
118990|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
118991|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
118992|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
118993|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
118994|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
118995|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
118996|NCT01892020|E2|Reported Event|BHI 50|This arm included the subjects received BHI 50.
118997|NCT01892020|E1|Reported Event|BIAsp 50|This arm included the subjects received BIAsp 50.
118998|NCT01891968|B1|Baseline|Bortezomib|Bortezomib administered via subcutaneous route at a dose of 1.3 mg/m2 on days 1, 4, 8 and 11 of a 21 day cycle. A course of treatment will be 21 days.
118999|NCT01891968|P1|Participant Flow|Bortezomib|Bortezomib administered via subcutaneous route at a dose of 1.3 mg/m2 on days 1, 4, 8 and 11 of a 21 day cycle. A course of treatment will be 21 days.
119000|NCT01891968|O1|Outcome|Bortezomib|Bortezomib administered via subcutaneous route at a dose of 1.3 mg/m2 on days 1, 4, 8 and 11 of a 21 day cycle. A course of treatment will be 21 days.
119001|NCT01891968|E1|Reported Event|Bortezomib|Bortezomib administered via subcutaneous route at a dose of 1.3 mg/m2 on days 1, 4, 8 and 11 of a 21 day cycle. A course of treatment will be 21 days.
119002|NCT01891890|B4|Baseline|Total|Total of all reporting groups
119003|NCT01891890|B3|Baseline|Levetiracetam|Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
119004|NCT01891890|B2|Baseline|Oxcarbazepine|Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
119005|NCT01891890|B1|Baseline|Lamotrigine|Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
119006|NCT01891890|P3|Participant Flow|Levetiracetam|Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
119007|NCT01891890|P2|Participant Flow|Oxcarbazepine|Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
119008|NCT01891890|P1|Participant Flow|Lamotrigine|Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
119009|NCT01891890|O3|Outcome|Levetiracetam|Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
119010|NCT01891890|O2|Outcome|Oxcarbazepine|Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
119011|NCT01891890|O1|Outcome|Lamotrigine|Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
119012|NCT01891890|O3|Outcome|Levetiracetam|Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
119013|NCT01891890|O2|Outcome|Oxcarbazepine|Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
119014|NCT01891890|O1|Outcome|Lamotrigine|Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
119015|NCT01891890|O3|Outcome|Levetiracetam|Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
119016|NCT01891890|O2|Outcome|Oxcarbazepine|Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
119017|NCT01891890|O1|Outcome|Lamotrigine|Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
119018|NCT01891890|O3|Outcome|Levetiracetam|Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
119019|NCT01891890|O2|Outcome|Oxcarbazepine|Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
119020|NCT01891890|O1|Outcome|Lamotrigine|Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
119021|NCT01891890|O3|Outcome|Levetiracetam|Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
119022|NCT01891890|O2|Outcome|Oxcarbazepine|Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
119023|NCT01891890|O1|Outcome|Lamotrigine|Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
119024|NCT01891890|O3|Outcome|Levetiracetam|Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
119025|NCT01891890|O2|Outcome|Oxcarbazepine|Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
119026|NCT01891890|O1|Outcome|Lamotrigine|Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
119027|NCT01891890|O3|Outcome|Levetiracetam|Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
119028|NCT01891890|O2|Outcome|Oxcarbazepine|Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
119029|NCT01891890|O1|Outcome|Lamotrigine|Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
119030|NCT01891890|O3|Outcome|Levetiracetam|Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
119031|NCT01891890|O2|Outcome|Oxcarbazepine|Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
119032|NCT01891890|O1|Outcome|Lamotrigine|Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
119033|NCT01891890|O3|Outcome|Levetiracetam|Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
119034|NCT01891890|O2|Outcome|Oxcarbazepine|Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
119035|NCT01891890|O1|Outcome|Lamotrigine|Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
119036|NCT01891890|O3|Outcome|Levetiracetam|Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
119037|NCT01891890|O2|Outcome|Oxcarbazepine|Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
119038|NCT01891890|O1|Outcome|Lamotrigine|Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
119039|NCT01891890|O3|Outcome|Levetiracetam|Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
119040|NCT01891890|O2|Outcome|Oxcarbazepine|Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
119041|NCT01891890|O1|Outcome|Lamotrigine|Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
119042|NCT01891890|O3|Outcome|Levetiracetam|Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
119043|NCT01891890|O2|Outcome|Oxcarbazepine|Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
119044|NCT01891890|O1|Outcome|Lamotrigine|Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
119045|NCT01891890|E3|Reported Event|Levetiracetam|Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
119046|NCT01891890|E2|Reported Event|Oxcarbazepine|Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
119047|NCT01891890|E1|Reported Event|Lamotrigine|Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
119048|NCT01891864|B3|Baseline|Total|Total of all reporting groups
119049|NCT01891864|B2|Baseline|Enbrel ® Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter~Enbrel ® Etanercept"
119050|NCT01891864|B1|Baseline|GP2015 Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter~GP2015 Etanercept"
119051|NCT01891864|P6|Participant Flow|Enbrel ® Etanercept Switched|"Enbrel ®/GP2015 50 mg subcutaneous (s.c.) injection of study drug until Week 30. Three periods of 6 weeks alternating between GP2015/Enbrel/GP2015 (Treatment Period 2).~GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
119052|NCT01891864|P5|Participant Flow|GP2015 Etanercept Switched|"GP2015/Enbrel ® 50 mg subcutaneous (s.c.) injection of study drug until Week 30. Three periods of 6 weeks alternating between Enbrel/GP2015/Enbrel (Treatment Period 2).~Enbrel ® 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
119053|NCT01891864|P4|Participant Flow|Enbrel ® Etanercept Continued|Enbrel ® 50 mg subcutaneous (s.c.) injection of study drug from week 13 until Week 30 (Treatment Period 2) Enbrel ® 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2.
119054|NCT01891864|P3|Participant Flow|GP2015 Etanercept Continued|"GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 13 until Week 30 (Treatment Period 2).~GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2"
119055|NCT01891864|P2|Participant Flow|Enbrel ® Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter~Enbrel ® Etanercept"
119056|NCT01891864|P1|Participant Flow|GP2015 Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter~GP2015 Etanercept"
119057|NCT01891864|O4|Outcome|Enbrel ® Etanercept Continued|"Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).~Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
119058|NCT01891864|O3|Outcome|GP2015 Etanercept Switched|"GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~GP2015 Etanercept /Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between Enbrel/GP2015/Enbrel (Treatment Period 2).~Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
119059|NCT01891864|O2|Outcome|Enbrel ® Etanercept Switched|"Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~Enbrel ® Etanercept /GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between GP2015/Enbrel/GP2015 (Treatment Period 2).~GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
119060|NCT01891864|O1|Outcome|GP2015 Etanercept Continued|"GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).~GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
119061|NCT01891864|O4|Outcome|Enbrel ® Etanercept Continued|"Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).~Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
119062|NCT01891864|O3|Outcome|GP2015 Etanercept Switched|"GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~GP2015 Etanercept /Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between Enbrel/GP2015/Enbrel (Treatment Period 2).~Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
119063|NCT01891864|O2|Outcome|Enbrel ® Etanercept Switched|"Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~Enbrel ® Etanercept /GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between GP2015/Enbrel/GP2015 (Treatment Period 2).~GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
119064|NCT01891864|O1|Outcome|GP2015 Etanercept Continued|"GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).~GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
119065|NCT01891864|O2|Outcome|Enbrel ® Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter~Enbrel ® Etanercept"
119066|NCT01891864|O1|Outcome|GP2015 Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter~GP2015 Etanercept"
119067|NCT01891864|O2|Outcome|Enbrel ® Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter~Enbrel ® Etanercept"
119068|NCT01891864|O1|Outcome|GP2015 Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter~GP2015 Etanercept"
119069|NCT01891864|O2|Outcome|Enbrel ® Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter~Enbrel ® Etanercept"
119070|NCT01891864|O1|Outcome|GP2015 Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter~GP2015 Etanercept"
119071|NCT01891864|E4|Reported Event|Enbrel ® Etanercept Continued|"Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).~Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
119072|NCT01891864|E3|Reported Event|GP2015 Etanercept Switched|"GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~GP2015 Etanercept /Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between Enbrel/GP2015/Enbrel (Treatment Period 2).~Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
119073|NCT01891864|E2|Reported Event|Enbrel ® Etanercept Switched|"Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~Enbrel ® Etanercept /GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between GP2015/Enbrel/GP2015 (Treatment Period 2).~GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
119074|NCT01891864|E1|Reported Event|GP2015 Etanercept Continued|"GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).~GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
119075|NCT01891734|B3|Baseline|Total|Total of all reporting groups
119076|NCT01891734|B2|Baseline|Problem Solving Therapy|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward workbook.
119259|NCT01890967|B6|Baseline|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119077|NCT01891734|B1|Baseline|Problem Solving Therapy-Moving Forward|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward app.
119078|NCT01891734|P2|Participant Flow|Problem Solving Therapy|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward workbook.
119079|NCT01891734|P1|Participant Flow|Problem Solving Therapy-Moving Forward|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward app.
119080|NCT01891734|O2|Outcome|Problem Solving Therapy|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes.~Problem Solving Therapy: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes."
119081|NCT01891734|O1|Outcome|Problem Solving Therapy Plus Moving Forward (PST-MF)|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes. Participants in this arm will also receive the Moving Forward app for SmartPhones, which was adapted from PST to be used either as a standalone treatment or as an adjunct to other related therapies such as in-person PST or the Moving Forward website. The phone content matches PST. Benefits of the app include 24-hours accessibility of psychoeducational materials and worksheets.~Problem Solving Therapy plus Moving Forward: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes"
119082|NCT01891734|O2|Outcome|Problem Solving Therapy|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes.~Problem Solving Therapy: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes."
119083|NCT01891734|O1|Outcome|Problem Solving Therapy Plus Moving Forward (PST-MF)|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes. Participants in this arm will also receive the Moving Forward app for SmartPhones, which was adapted from PST to be used either as a standalone treatment or as an adjunct to other related therapies such as in-person PST or the Moving Forward website. The phone content matches PST. Benefits of the app include 24-hours accessibility of psychoeducational materials and worksheets.~Problem Solving Therapy plus Moving Forward: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes"
119084|NCT01891734|O2|Outcome|Problem Solving Therapy|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward workbook.
119085|NCT01891734|O1|Outcome|Problem Solving Therapy-Moving Forward|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward app.
119111|NCT01891669|O7|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119112|NCT01891669|O6|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119460|NCT01890694|O1|Outcome|Tolvaptan|Subjects will receive Tolvaptan once daily.
119086|NCT01891734|E2|Reported Event|Problem Solving Therapy|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes.~Problem Solving Therapy: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes."
119087|NCT01891734|E1|Reported Event|Problem Solving Therapy Plus Moving Forward (PST-MF)|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes. Participants in this arm will also receive the Moving Forward app for SmartPhones, which was adapted from PST to be used either as a standalone treatment or as an adjunct to other related therapies such as in-person PST or the Moving Forward website. The phone content matches PST. Benefits of the app include 24-hours accessibility of psychoeducational materials and worksheets.~Problem Solving Therapy plus Moving Forward: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes"
119088|NCT01891669|B11|Baseline|Total|Total of all reporting groups
119089|NCT01891669|B10|Baseline|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119090|NCT01891669|B9|Baseline|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119091|NCT01891669|B8|Baseline|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119092|NCT01891669|B7|Baseline|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119093|NCT01891669|B6|Baseline|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119094|NCT01891669|B5|Baseline|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119095|NCT01891669|B4|Baseline|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119096|NCT01891669|B3|Baseline|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119097|NCT01891669|B2|Baseline|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119098|NCT01891669|B1|Baseline|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119099|NCT01891669|P10|Participant Flow|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119100|NCT01891669|P9|Participant Flow|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119101|NCT01891669|P8|Participant Flow|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119102|NCT01891669|P7|Participant Flow|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119103|NCT01891669|P6|Participant Flow|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119104|NCT01891669|P5|Participant Flow|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119105|NCT01891669|P4|Participant Flow|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119106|NCT01891669|P3|Participant Flow|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119107|NCT01891669|P2|Participant Flow|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119108|NCT01891669|P1|Participant Flow|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119109|NCT01891669|O9|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119110|NCT01891669|O8|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119113|NCT01891669|O5|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119114|NCT01891669|O4|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119115|NCT01891669|O3|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119116|NCT01891669|O2|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119117|NCT01891669|O1|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119118|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119119|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119120|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119121|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119122|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119123|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119124|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119125|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119126|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119127|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119128|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119129|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119130|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119131|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119132|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119133|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119134|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119135|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119136|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119137|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119138|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119139|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119140|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119141|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119258|NCT01890967|B7|Baseline|Total|Total of all reporting groups
119142|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119143|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119144|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119145|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119146|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119147|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119148|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119149|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119150|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119151|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119152|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119153|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119154|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119155|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119156|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119157|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119158|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119159|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119160|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119161|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119162|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119163|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119164|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119165|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119166|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119167|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119168|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119169|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119170|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119461|NCT01890694|O2|Outcome|Placebo|Study Terminated. No data analyzed
119171|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119172|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119173|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119174|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119175|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119176|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119177|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119178|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119179|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119180|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119181|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119182|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119183|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119184|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119185|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119186|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119187|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119188|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119189|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119190|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119191|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119192|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119193|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119194|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119195|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119196|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119197|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119198|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119199|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
136510|NCT01806857|O2|Outcome|Matching Placebo|
119200|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119201|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119202|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119203|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119204|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119205|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119206|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119207|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119208|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119209|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119210|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119211|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119212|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119213|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119214|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119215|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119216|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119217|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119218|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119219|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119220|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119221|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119222|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119223|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119224|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119225|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119226|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119227|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119228|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
136511|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
119229|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119230|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119231|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119232|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119233|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119234|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119235|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119236|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119237|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119238|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119239|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119240|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119241|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119242|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119243|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119244|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119245|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119246|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119247|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119248|NCT01891669|E10|Reported Event|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119249|NCT01891669|E9|Reported Event|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119250|NCT01891669|E8|Reported Event|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119251|NCT01891669|E7|Reported Event|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119252|NCT01891669|E6|Reported Event|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119253|NCT01891669|E5|Reported Event|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119254|NCT01891669|E4|Reported Event|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119255|NCT01891669|E3|Reported Event|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119256|NCT01891669|E2|Reported Event|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119257|NCT01891669|E1|Reported Event|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
119260|NCT01890967|B5|Baseline|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119261|NCT01890967|B4|Baseline|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119262|NCT01890967|B3|Baseline|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119263|NCT01890967|B2|Baseline|20 mg LY3015014 Q4W|"20 mg LY3015014 given subcutaneously SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119264|NCT01890967|B1|Baseline|Placebo Q4W|"Placebo given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119265|NCT01890967|P6|Participant Flow|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119266|NCT01890967|P5|Participant Flow|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC once every 8 weeks (Q8W) for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119267|NCT01890967|P4|Participant Flow|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119268|NCT01890967|P3|Participant Flow|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119269|NCT01890967|P2|Participant Flow|20 mg LY3015014 Q4W|"20 milligrams (mg) LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119270|NCT01890967|P1|Participant Flow|Placebo Q4W|"Placebo given subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119271|NCT01890967|O6|Outcome|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119272|NCT01890967|O5|Outcome|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119273|NCT01890967|O4|Outcome|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119274|NCT01890967|O3|Outcome|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119275|NCT01890967|O2|Outcome|20 mg LY3015014 Q4W|"20 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119276|NCT01890967|O1|Outcome|Placebo Q4W|"Placebo given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119277|NCT01890967|O5|Outcome|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119278|NCT01890967|O4|Outcome|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119279|NCT01890967|O3|Outcome|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119280|NCT01890967|O2|Outcome|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119281|NCT01890967|O1|Outcome|20 mg LY3015014 Q4W|"20 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119282|NCT01890967|O6|Outcome|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119283|NCT01890967|O5|Outcome|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119284|NCT01890967|O4|Outcome|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119285|NCT01890967|O3|Outcome|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119286|NCT01890967|O2|Outcome|20 mg LY3015014 Q4W|"20 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119287|NCT01890967|O1|Outcome|Placebo Q4W|"Placebo given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119288|NCT01890967|O6|Outcome|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119289|NCT01890967|O5|Outcome|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119290|NCT01890967|O4|Outcome|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119291|NCT01890967|O3|Outcome|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119292|NCT01890967|O2|Outcome|20 mg LY3015014 Q4W|"20 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119293|NCT01890967|O1|Outcome|Placebo Q4W|"Placebo given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119294|NCT01890967|O6|Outcome|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119295|NCT01890967|O5|Outcome|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119296|NCT01890967|O4|Outcome|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119297|NCT01890967|O3|Outcome|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119298|NCT01890967|O2|Outcome|20 mg LY3015014 Q4W|"20 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119299|NCT01890967|O1|Outcome|Placebo Q4W|"Placebo given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119300|NCT01890967|O6|Outcome|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119301|NCT01890967|O5|Outcome|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119302|NCT01890967|O4|Outcome|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119303|NCT01890967|O3|Outcome|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119304|NCT01890967|O2|Outcome|20 mg LY3015014 Q4W|"20 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119305|NCT01890967|O1|Outcome|Placebo Q4W|"Placebo given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119306|NCT01890967|O6|Outcome|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119307|NCT01890967|O5|Outcome|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119308|NCT01890967|O4|Outcome|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119309|NCT01890967|O3|Outcome|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119310|NCT01890967|O2|Outcome|20 mg LY3015014 Q4W|"20 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119311|NCT01890967|O1|Outcome|Placebo Q4W|"Placebo given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119312|NCT01890967|O6|Outcome|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119313|NCT01890967|O5|Outcome|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119314|NCT01890967|O4|Outcome|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119315|NCT01890967|O3|Outcome|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119316|NCT01890967|O2|Outcome|20 mg LY3015014 Q4W|"20 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119317|NCT01890967|O1|Outcome|Placebo Q4W|"Placebo given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119318|NCT01890967|O6|Outcome|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119319|NCT01890967|O5|Outcome|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119320|NCT01890967|O4|Outcome|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119321|NCT01890967|O3|Outcome|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119322|NCT01890967|O2|Outcome|20 mg LY3015014 Q4W|"20 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119323|NCT01890967|O1|Outcome|Placebo Q4W|"Placebo given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119324|NCT01890967|O6|Outcome|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119325|NCT01890967|O5|Outcome|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119326|NCT01890967|O4|Outcome|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119327|NCT01890967|O3|Outcome|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119328|NCT01890967|O2|Outcome|20 mg LY3015014 Q4W|"20 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119329|NCT01890967|O1|Outcome|Placebo Q4W|"Placebo given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119330|NCT01890967|E6|Reported Event|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119331|NCT01890967|E5|Reported Event|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119332|NCT01890967|E4|Reported Event|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119333|NCT01890967|E3|Reported Event|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119334|NCT01890967|E2|Reported Event|20 mg LY3015014 Q4W|"20 mg LY3015014 given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119335|NCT01890967|E1|Reported Event|Placebo Q4W|"Placebo given SC Q4W for 16 weeks.~Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
119336|NCT01890954|B3|Baseline|Total|Total of all reporting groups
119337|NCT01890954|B2|Baseline|Closed Loop Control First, Then Usual Care|8 hours observational (09:00-17:00) using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours observational during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
119338|NCT01890954|B1|Baseline|Usual Care First, Then Closed Loop Control|8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00).
119339|NCT01890954|P2|Participant Flow|Closed Loop Control First, Then Usual Care|8 hours observational (09:00-17:00) using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
119340|NCT01890954|P1|Participant Flow|Usual Care First, Then Closed Loop Control|8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00).
119341|NCT01890954|O2|Outcome|Usual Care Without DiAs System (CGM Only)|8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
119342|NCT01890954|O1|Outcome|Closed Loop Control With DiAs System|8 hours observational (09:00-17:00) during closed-loop control (DiAs) with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
119343|NCT01890954|E2|Reported Event|Usual Care Without DiAs System (CGM Only)|8 hours observational under both, missed insulin bolus for 30 gr carbohydrates snack and under bolus for an 80 gr carbohydrates lunch.
119344|NCT01890954|E1|Reported Event|Closed Loop Control With DiAs System|"8 hours using Closed Loop Control with DiAs under both, miss insulin bolus for 30 grams of carbohydrates snack or under bolus for an 80 grams of carbohydrates lunch~Diabetes Assistant (DiAs)"
119345|NCT01890915|B3|Baseline|Total|Total of all reporting groups
119346|NCT01890915|B2|Baseline|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
119347|NCT01890915|B1|Baseline|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
119348|NCT01890915|P2|Participant Flow|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
119349|NCT01890915|P1|Participant Flow|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, American Spinal Injury Association (ASIA) impairment levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
119350|NCT01890915|O2|Outcome|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
119351|NCT01890915|O1|Outcome|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
119352|NCT01890915|O2|Outcome|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
136512|NCT01806857|O2|Outcome|Matching Placebo|
119353|NCT01890915|O1|Outcome|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
119354|NCT01890915|O2|Outcome|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
119355|NCT01890915|O1|Outcome|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
119356|NCT01890915|E2|Reported Event|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
119357|NCT01890915|E1|Reported Event|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
119358|NCT01890785|B7|Baseline|Total|Total of all reporting groups
119359|NCT01890785|B6|Baseline|Sequence 6|Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
119360|NCT01890785|B5|Baseline|Sequence 5|Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
119361|NCT01890785|B4|Baseline|Sequence 4|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
119362|NCT01890785|B3|Baseline|Sequence 3|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
119363|NCT01890785|B2|Baseline|Sequence 2|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
119364|NCT01890785|B1|Baseline|Sequence 1|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
119365|NCT01890785|P6|Participant Flow|Sequence 6|Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
119366|NCT01890785|P5|Participant Flow|Sequence 5|Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
119367|NCT01890785|P4|Participant Flow|Sequence 4|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
119368|NCT01890785|P3|Participant Flow|Sequence 3|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
119369|NCT01890785|P2|Participant Flow|Sequence 2|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
119370|NCT01890785|P1|Participant Flow|Sequence 1|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
119371|NCT01890785|O3|Outcome|Lisdexamfetamine Dimesylate Intact Capsule Fasting|lisdexamfetamine dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
119372|NCT01890785|O2|Outcome|Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt (Single dose of a 70 mg capsule on Day 1)
119373|NCT01890785|O1|Outcome|Lisdexamfetamine Dimesylate Mixed in Orange Juice|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
119374|NCT01890785|O3|Outcome|Lisdexamfetamine Dimesylate Intact Capsule Fasting|lisdexamfetamine dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
119375|NCT01890785|O2|Outcome|Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt (Single dose of a 70 mg capsule on Day 1)
119376|NCT01890785|O1|Outcome|Lisdexamfetamine Dimesylate Mixed in Orange Juice|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
119377|NCT01890785|O3|Outcome|Lisdexamfetamine Dimesylate Intact Capsule Fasting|lisdexamfetamine dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
119378|NCT01890785|O2|Outcome|Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt (Single dose of a 70 mg capsule on Day 1)
119379|NCT01890785|O1|Outcome|Lisdexamfetamine Dimesylate Mixed in Orange Juice|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
119380|NCT01890785|O3|Outcome|Lisdexamfetamine Dimesylate Intact Capsule Fasting|Lisdexamfetamine Dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
119381|NCT01890785|O2|Outcome|Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt (Single dose of a 70 mg capsule on Day 1)
119462|NCT01890694|O1|Outcome|Tolvaptan|Subjects will receive Tolvaptan once daily.
119382|NCT01890785|O1|Outcome|Lisdexamfetamine Dimesylate Mixed in Orange Juice|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
119383|NCT01890785|E3|Reported Event|Lisdexamfetamine Dimesylate Intact Capsule Fasting|Lisdexamfetamine Dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
119384|NCT01890785|E2|Reported Event|Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt(Single dose of a 70 mg capsule on Day 1)
119385|NCT01890785|E1|Reported Event|Lisdexamfetamine Dimesylate Mixed in Orange Juice|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
119386|NCT01890759|B3|Baseline|Total|Total of all reporting groups
119387|NCT01890759|B2|Baseline|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119388|NCT01890759|B1|Baseline|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119389|NCT01890759|P2|Participant Flow|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119390|NCT01890759|P1|Participant Flow|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119391|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119392|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119393|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119394|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119395|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119396|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119397|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119398|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119399|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119400|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119401|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119402|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119403|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119404|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119405|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119406|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119407|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119408|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119409|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119410|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119411|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119412|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119413|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119414|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119415|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119416|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119417|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119418|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119419|NCT01890759|E2|Reported Event|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119420|NCT01890759|E1|Reported Event|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
119421|NCT01890746|B3|Baseline|Total|Total of all reporting groups
119422|NCT01890746|B2|Baseline|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
119423|NCT01890746|B1|Baseline|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
119424|NCT01890746|P2|Participant Flow|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
119425|NCT01890746|P1|Participant Flow|Eltrombopag (ELT) QD|Par. received (rec) first line induction (IDN) chemotherapy (CTY) consisting of daunorubicin (DAU) bolus intravenous (IV) infusion (INF) on Days (D) 1-3 at a dose of 90 milligrams (mg)/square meter (m^2) for Par. 18-60 year (yr) or 60 mg/m^2 for >60 yr plus cytarabine (CB) 100 mg/m^2 continuous IV INF on D1-7. Par. rec ELT as 200 mg (100 mg for East-Asian Heritage [EAH]) once daily (QD) oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If platelet (PT) count was not >100 Giga (Gi)/Liter (L) after 7D the dose was increased to 300 mg (150 mg for EAH) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42D from the start of the CTY IDN cycle. Par. not aplastic after first cycle of IDN CTY rec re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus CB 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
119426|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
119427|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
119428|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
119463|NCT01890694|O2|Outcome|Placebo|Study Terminated. No data analyzed
119429|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
119430|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
119431|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
119432|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
119433|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
119434|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
119435|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
119436|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
119437|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
119438|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
119464|NCT01890694|O1|Outcome|Tolvaptan|Subjects will receive Tolvaptan once daily.
119465|NCT01890694|O2|Outcome|Placebo|Study Terminated. No data analyzed
119466|NCT01890694|O1|Outcome|Tolvaptan|Subjects will receive Tolvaptan once daily.
119467|NCT01890694|O2|Outcome|Placebo|Study Terminated. No data analyzed
119468|NCT01890694|O1|Outcome|Tolvaptan|Subjects will receive Tolvaptan once daily.
119469|NCT01890694|O2|Outcome|Placebo|Study Terminated. No data analyzed
119470|NCT01890694|O1|Outcome|Tolvaptan|Subjects will receive Tolvaptan once daily.
119471|NCT01890694|O2|Outcome|Placebo|Study Terminated. No data analyzed
119439|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
119440|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
119441|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
119442|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
119443|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
119444|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
119445|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
119446|NCT01890746|E2|Reported Event|Placebo QD|Participants received first line induction chemotherapy consisted of daunorubicin bolus IV infusion on Days 1 – 3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants &gt;60 years of age plus cytarabine continuous IV infusion on Days 1 – 7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose started on Day 4 of initial induction chemotherapy at least 20 hours after end of Day 3 daunorubicin infusion up to a maximum duration of 42 days.
119447|NCT01890746|E1|Reported Event|Eltrombopag QD|Par. received IDN CTY of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.&gt;60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg QD oral dose started on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not &gt;100 Gi/L after 7 days the dose was increased to 300 mg QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par.who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
119448|NCT01890694|B3|Baseline|Total|Total of all reporting groups
119449|NCT01890694|B2|Baseline|Tolvaptan|Subjects will receive 15 mg Tolvaptan once daily.
119450|NCT01890694|B1|Baseline|Placebo|Subjects will receive placebo once daily.
119451|NCT01890694|P2|Participant Flow|Tolvaptan|Subjects will receive 15 mg Tolvaptan once daily.
119452|NCT01890694|P1|Participant Flow|Placebo|Subjects will receive placebo once daily.
119453|NCT01890694|O2|Outcome|Placebo|Study Terminated. No data analyzed
119454|NCT01890694|O1|Outcome|Tolvaptan|Subjects will receive Tolvaptan once daily.
119455|NCT01890694|O2|Outcome|Placebo|Study Terminated. No data analyzed
119456|NCT01890694|O1|Outcome|Tolvaptan|Subjects will receive Tolvaptan once daily.
119457|NCT01890694|O2|Outcome|Placebo|Study Terminated. No data analyzed
119458|NCT01890694|O1|Outcome|Tolvaptan|Subjects will receive Tolvaptan once daily.
119459|NCT01890694|O2|Outcome|Placebo|Study Terminated. No data analyzed
119484|NCT01890642|B3|Baseline|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
119485|NCT01890642|B2|Baseline|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
119486|NCT01890642|B1|Baseline|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
119487|NCT01890642|P3|Participant Flow|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
119488|NCT01890642|P2|Participant Flow|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
119489|NCT01890642|P1|Participant Flow|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
119490|NCT01890642|O3|Outcome|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
119491|NCT01890642|O2|Outcome|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
119492|NCT01890642|O1|Outcome|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
119493|NCT01890642|O3|Outcome|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
119494|NCT01890642|O2|Outcome|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
119495|NCT01890642|O1|Outcome|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
119496|NCT01890642|O3|Outcome|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
119497|NCT01890642|O2|Outcome|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
119498|NCT01890642|O1|Outcome|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
119499|NCT01890642|O3|Outcome|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
119500|NCT01890642|O2|Outcome|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
119501|NCT01890642|O1|Outcome|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
119502|NCT01890642|O3|Outcome|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
119503|NCT01890642|O2|Outcome|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
119504|NCT01890642|O1|Outcome|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
119505|NCT01890642|E3|Reported Event|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
119506|NCT01890642|E2|Reported Event|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
119507|NCT01890642|E1|Reported Event|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
119508|NCT01890577|B1|Baseline|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
119509|NCT01890577|P1|Participant Flow|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
119510|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
119511|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
119512|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
119513|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
119514|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
119515|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
119516|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
119517|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
119518|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
119519|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
119520|NCT01890577|E1|Reported Event|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
119521|NCT01890512|B1|Baseline|ImageReady Pacemaker|patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
119522|NCT01890512|P1|Participant Flow|ImageReady Pacemaker|patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
119523|NCT01890512|O1|Outcome|ImageReady Pacemaker|patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
119524|NCT01890512|E1|Reported Event|ImageReady Pacemaker|patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
119525|NCT01890473|B3|Baseline|Total|Total of all reporting groups
119526|NCT01890473|B2|Baseline|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe (PFS).
119527|NCT01890473|B1|Baseline|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered subcutaneously (SC) via an autoinjector.
119528|NCT01890473|P2|Participant Flow|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe (PFS).
119529|NCT01890473|P1|Participant Flow|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered subcutaneously (SC) via an autoinjector.
119530|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
119531|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
119532|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
119533|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
119534|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe (PFS).
119535|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered subcutaneously (SC) via an autoinjector.
119536|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
119537|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
119538|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
119539|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
119540|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
119541|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
119542|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
119543|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
119544|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
119545|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
119546|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe (PFS).
119547|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered subcutaneously (SC) via an autoinjector.
119548|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
119549|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
119550|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe (PFS).
119551|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered subcutaneously (SC) via an autoinjector.
119552|NCT01890473|E2|Reported Event|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a PFS.
119553|NCT01890473|E1|Reported Event|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
119554|NCT01890434|B1|Baseline|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119555|NCT01890434|P1|Participant Flow|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119556|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119557|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119558|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119559|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119560|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119561|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119562|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119563|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119564|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119565|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119566|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119567|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119568|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119569|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119570|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119571|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119572|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119573|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119574|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119640|NCT01890122|B4|Baseline|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119575|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119576|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119577|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119578|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119579|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119580|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119581|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119582|NCT01890434|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119583|NCT01890434|E1|Reported Event|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 mmol/kg BW in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119584|NCT01890421|B1|Baseline|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119585|NCT01890421|P1|Participant Flow|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119586|NCT01890421|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119587|NCT01890421|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119588|NCT01890421|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119589|NCT01890421|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119590|NCT01890421|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119591|NCT01890421|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119592|NCT01890421|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119593|NCT01890421|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119594|NCT01890421|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119595|NCT01890421|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119596|NCT01890421|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119597|NCT01890421|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
120407|NCT01884545|O2|Outcome|Non-Health Coaching|Participants who did not receive health coaching
119598|NCT01890421|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119599|NCT01890421|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119600|NCT01890421|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119601|NCT01890421|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119602|NCT01890421|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119603|NCT01890421|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119604|NCT01890421|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119605|NCT01890421|O1|Outcome|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119606|NCT01890421|E1|Reported Event|Gadobutrol 0.1 mmol/kg Body Weight|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
119607|NCT01890343|B4|Baseline|Total|Total of all reporting groups
119608|NCT01890343|B3|Baseline|Alzheimer's Disease|"Subjects with Alzheimer's disease (AD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
119609|NCT01890343|B2|Baseline|Cognitively Normal|"Cognitively normal (CN) subjects.~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
119610|NCT01890343|B1|Baseline|Frontotemporal Disorder|"Subjects with frontotemporal disorder (FTD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.~18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG."
119611|NCT01890343|P3|Participant Flow|Alzheimer's Disease|"Subjects with Alzheimer's disease (AD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
119612|NCT01890343|P2|Participant Flow|Cognitively Normal|"Cognitively normal (CN) subjects.~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
119613|NCT01890343|P1|Participant Flow|Frontotemporal Disorder|"Subjects with frontotemporal disorder (FTD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.~18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG."
119614|NCT01890343|O3|Outcome|Alzheimer's Disease|"Subjects with Alzheimer's disease (AD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
119615|NCT01890343|O2|Outcome|Cognitively Normal|"Cognitively normal (CN) subjects.~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
119616|NCT01890343|O1|Outcome|Frontotemporal Disorder|"Subjects with frontotemporal disorder (FTD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.~18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG."
119617|NCT01890343|O3|Outcome|Alzheimer's Disease|"Subjects with Alzheimer's disease (AD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
119618|NCT01890343|O2|Outcome|Cognitively Normal|"Cognitively normal (CN) subjects.~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
119619|NCT01890343|O1|Outcome|Frontotemporal Disorder|"Subjects with frontotemporal disorder (FTD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.~18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG."
119620|NCT01890343|E3|Reported Event|Alzheimer's Disease|"Subjects with Alzheimer's disease (AD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
119621|NCT01890343|E2|Reported Event|Cognitively Normal|"Cognitively normal (CN) subjects.~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
119622|NCT01890343|E1|Reported Event|Frontotemporal Disorder|"Subjects with frontotemporal disorder (FTD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.~18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG."
119623|NCT01890148|B1|Baseline|AZD5069|AZD5069 45mg oral twice daily (BID)
119624|NCT01890148|P1|Participant Flow|AZD5069|AZD5069 45mg oral twice daily (BID)
119625|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
119626|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
119627|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
119628|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
119629|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
119641|NCT01890122|B3|Baseline|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119642|NCT01890122|B2|Baseline|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
119643|NCT01890122|B1|Baseline|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
119644|NCT01890122|P4|Participant Flow|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119645|NCT01890122|P3|Participant Flow|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119646|NCT01890122|P2|Participant Flow|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
119647|NCT01890122|P1|Participant Flow|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
119648|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119649|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119650|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
119651|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
119652|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119653|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119654|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
119655|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
119656|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119657|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119658|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
119659|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
119660|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119661|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119662|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
119663|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
119664|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119665|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119666|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
136513|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
119667|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
119668|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119669|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119670|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
119671|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
119672|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119673|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119674|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
119675|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
119676|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119677|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119678|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
119679|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
119680|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119681|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119682|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
119683|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
119684|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119685|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119686|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
119687|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
119688|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119689|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119690|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
119691|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
119692|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
120408|NCT01884545|O1|Outcome|Health Coaching|Participants who received health coaching
119693|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119694|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
119695|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
119696|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119697|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119698|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
119699|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
119700|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119701|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119702|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
119703|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
119704|NCT01890122|E4|Reported Event|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119705|NCT01890122|E3|Reported Event|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
119706|NCT01890122|E2|Reported Event|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
119707|NCT01890122|E1|Reported Event|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
119708|NCT01890031|B6|Baseline|Total|Total of all reporting groups
119709|NCT01890031|B5|Baseline|Low Risk, ICAT, and Study Physician|Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits
119710|NCT01890031|B4|Baseline|Moderate Risk, ICAT|"Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
119711|NCT01890031|B3|Baseline|Moderate Risk, no ICAT|"Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
119712|NCT01890031|B2|Baseline|Low Risk, ICAT|"Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education."
119713|NCT01890031|B1|Baseline|Low Risk, No ICAT|Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
119714|NCT01890031|P5|Participant Flow|Low Risk, ICAT, and Study Physician|Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits
119715|NCT01890031|P4|Participant Flow|Moderate Risk, ICAT|"Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
119716|NCT01890031|P3|Participant Flow|Moderate Risk, no ICAT|"Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
119717|NCT01890031|P2|Participant Flow|Low Risk, ICAT|"Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education."
119718|NCT01890031|P1|Participant Flow|Low Risk, No ICAT|Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
119719|NCT01890031|O5|Outcome|Low Risk, ICAT, and Study Physician|Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits
119760|NCT01889667|O2|Outcome|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules"
119761|NCT01889667|O1|Outcome|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules"
119720|NCT01890031|O4|Outcome|Moderate Risk, ICAT|"Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
119721|NCT01890031|O3|Outcome|Moderate Risk, no ICAT|"Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
119722|NCT01890031|O2|Outcome|Low Risk, ICAT|"Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education."
119723|NCT01890031|O1|Outcome|Low Risk, No ICAT|Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
119724|NCT01890031|O5|Outcome|Low Risk, ICAT, and Study Physician|Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits
119725|NCT01890031|O4|Outcome|Moderate Risk, ICAT|"Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
119726|NCT01890031|O3|Outcome|Moderate Risk, no ICAT|"Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
119727|NCT01890031|O2|Outcome|Low Risk, ICAT|"Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education."
119728|NCT01890031|O1|Outcome|Low Risk, No ICAT|Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
119729|NCT01890031|E5|Reported Event|Low Risk, ICAT, and Study Physician|Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits
119730|NCT01890031|E4|Reported Event|Moderate Risk, ICAT|"Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
119731|NCT01890031|E3|Reported Event|Moderate Risk, no ICAT|"Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
119732|NCT01890031|E2|Reported Event|Low Risk, ICAT|"Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education."
119733|NCT01890031|E1|Reported Event|Low Risk, No ICAT|Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
119734|NCT01889797|B3|Baseline|Total|Total of all reporting groups
119735|NCT01889797|B2|Baseline|Arm B: GA101|"GA101 1,000 mg IV weekly for 4 weeks.~Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses."
119736|NCT01889797|B1|Baseline|Arm A: Rituximab|"Rituximab 375 mg/m² IV weekly for 4 weeks.~Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses."
119737|NCT01889797|P2|Participant Flow|Arm B: GA101|"GA101 1,000 mg IV weekly for 4 weeks.~Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses."
119738|NCT01889797|P1|Participant Flow|Arm A: Rituximab|"Rituximab 375 mg/m² IV weekly for 4 weeks.~Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses."
119739|NCT01889797|O2|Outcome|Arm B: GA101|"GA101 1,000 mg IV weekly for 4 weeks.~Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses."
119740|NCT01889797|O1|Outcome|Arm A: Rituximab|"Rituximab 375 mg/m² IV weekly for 4 weeks.~Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses."
119741|NCT01889797|O2|Outcome|Arm B: GA101|"GA101 1,000 mg IV weekly for 4 weeks.~Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses."
119742|NCT01889797|O1|Outcome|Arm A: Rituximab|"Rituximab 375 mg/m² IV weekly for 4 weeks.~Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses."
119743|NCT01889797|O2|Outcome|Arm B: GA101|"GA101 1,000 mg IV weekly for 4 weeks.~Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses."
119744|NCT01889797|O1|Outcome|Arm A: Rituximab|"Rituximab 375 mg/m² IV weekly for 4 weeks.~Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses."
119745|NCT01889797|O2|Outcome|Arm B: GA101|"GA101 1,000 mg IV weekly for 4 weeks.~Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses."
119746|NCT01889797|O1|Outcome|Arm A: Rituximab|"Rituximab 375 mg/m² IV weekly for 4 weeks.~Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses."
119747|NCT01889797|E2|Reported Event|Arm B: GA101|"GA101 1,000 mg IV weekly for 4 weeks.~Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses."
119748|NCT01889797|E1|Reported Event|Arm A: Rituximab|"Rituximab 375 mg/m² IV weekly for 4 weeks.~Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses."
119749|NCT01889667|B4|Baseline|Total|Total of all reporting groups
119750|NCT01889667|B3|Baseline|Placebo|"Oil Capsules~Placebo: Oil Capsules"
119751|NCT01889667|B2|Baseline|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules"
119752|NCT01889667|B1|Baseline|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules"
119753|NCT01889667|P3|Participant Flow|Placebo|"Oil Capsules~Placebo: Oil Capsules"
119754|NCT01889667|P2|Participant Flow|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation"
119755|NCT01889667|P1|Participant Flow|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation"
119756|NCT01889667|O3|Outcome|Placebo|"Oil Capsules~Placebo: Oil Capsules"
119757|NCT01889667|O2|Outcome|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules"
119758|NCT01889667|O1|Outcome|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules"
119759|NCT01889667|O3|Outcome|Placebo|"Oil Capsules~Placebo: Oil Capsules"
119763|NCT01889667|O2|Outcome|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules"
119764|NCT01889667|O1|Outcome|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules"
119765|NCT01889667|O3|Outcome|Placebo|"Oil Capsules~Placebo: Oil Capsules"
119766|NCT01889667|O2|Outcome|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules"
119767|NCT01889667|O1|Outcome|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules"
119768|NCT01889667|O3|Outcome|Placebo|"Oil Capsules~Placebo: Oil Capsules"
119769|NCT01889667|O2|Outcome|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation"
119770|NCT01889667|O1|Outcome|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation"
119771|NCT01889667|E3|Reported Event|Placebo|"Oil Capsules~Placebo: Oil Capsules"
119772|NCT01889667|E2|Reported Event|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation (24 mg)"
119773|NCT01889667|E1|Reported Event|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation (16 mg)"
119774|NCT01889563|B3|Baseline|Total|Total of all reporting groups
119775|NCT01889563|B2|Baseline|No Physical Exercise Training Program|No Physical Exercise Training Program
119776|NCT01889563|B1|Baseline|Physical Exercise Training Program|Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
119777|NCT01889563|P2|Participant Flow|No Physical Exercise Training Program|No Physical Exercise Training Program
119778|NCT01889563|P1|Participant Flow|Physical Exercise Training Program|Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
119779|NCT01889563|O2|Outcome|No Physical Exercise Training Program|No Physical Exercise Training Program
119780|NCT01889563|O1|Outcome|Physical Exercise Training Program|Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
119781|NCT01889563|O2|Outcome|No Physical Exercise Training Program|No Physical Exercise Training Program
119782|NCT01889563|O1|Outcome|Physical Exercise Training Program|Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
119783|NCT01889563|E2|Reported Event|No Physical Exercise Training Program|No Physical Exercise Training Program
119784|NCT01889563|E1|Reported Event|Physical Exercise Training Program|Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
119785|NCT01889420|B1|Baseline|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle~Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.~Cycles will span 28 days. Dosage schedules will be:~Everolimus daily for 28 days of a 28 day cycle;~Pomalidomide daily for 21 days of a 28 day cycle~Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
119786|NCT01889420|P1|Participant Flow|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle~Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.~Cycles will span 28 days. Dosage schedules will be:~Everolimus daily for 28 days of a 28 day cycle;~Pomalidomide daily for 21 days of a 28 day cycle~Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
119787|NCT01889420|O1|Outcome|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle~Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.~Cycles will span 28 days. Dosage schedules will be:~Everolimus daily for 28 days of a 28 day cycle;~Pomalidomide daily for 21 days of a 28 day cycle~Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
136514|NCT01806857|O2|Outcome|Matching Placebo|
119788|NCT01889420|O1|Outcome|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle~Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.~Cycles will span 28 days. Dosage schedules will be:~Everolimus daily for 28 days of a 28 day cycle;~Pomalidomide daily for 21 days of a 28 day cycle~Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
119789|NCT01889420|O1|Outcome|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle~Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.~Cycles will span 28 days. Dosage schedules will be:~Everolimus daily for 28 days of a 28 day cycle;~Pomalidomide daily for 21 days of a 28 day cycle~Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
119790|NCT01889420|E1|Reported Event|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle~Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.~Cycles will span 28 days. Dosage schedules will be:~Everolimus daily for 28 days of a 28 day cycle;~Pomalidomide daily for 21 days of a 28 day cycle~Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
119791|NCT01889251|B3|Baseline|Total|Total of all reporting groups
119792|NCT01889251|B2|Baseline|Sham Injection|Single sham injection to the study eye at baseline
119793|NCT01889251|B1|Baseline|Ocriplasmin|Single intravitreal injection to the study eye at baseline
119794|NCT01889251|P2|Participant Flow|Sham Injection|Single sham injection to the study eye at baseline
119795|NCT01889251|P1|Participant Flow|Ocriplasmin|Single intravitreal injection to the study eye at baseline
119796|NCT01889251|O2|Outcome|Sham Injection|Single sham injection to the study eye at baseline
119797|NCT01889251|O1|Outcome|Ocriplasmin|Single intravitreal injection to the study eye at baseline
119798|NCT01889251|E2|Reported Event|Sham Injection|Single sham injection to the study eye at baseline
119799|NCT01889251|E1|Reported Event|Ocriplasmin|Single intravitreal injection to the study eye at baseline
119800|NCT01888965|B1|Baseline|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years~Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
119801|NCT01888965|P1|Participant Flow|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years~Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
119802|NCT01888965|O1|Outcome|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years~Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
119803|NCT01888965|O1|Outcome|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years~Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
119804|NCT01888965|O1|Outcome|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years~Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
119805|NCT01888965|E1|Reported Event|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years~Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
119806|NCT01888952|B1|Baseline|Roflumilast and Prednisone|"Roflumilast 500 mcg will be administered orally daily for 21 consecutive days (a 21-day cycle).~In Cycle 1, prednisone 60 mg/m2 up to a maximum of 100 mg oral (PO) daily will be taken on Days 8 through 14 at the same time as roflumilast.~In Cycle 2 and subsequent cycles, prednisone 60 mg/m2 PO up to a maximum of 100 mg daily will be taken on Days 1 through 7 at the same time as roflumilast.~Prednisone: Patients may receive additional courses of treatment with prednisone (and roflumilast) at the discretion of the investigator if they did not experience unacceptable toxicity and have stable disease or objectively responding disease.~Roflumilast: Patients may receive additional courses of treatment with roflumilast (and prednisone) at the discretion of the investigator if they did not experience unacceptable toxicity, and have stable disease or objectively responding disease."
119807|NCT01888952|P1|Participant Flow|Roflumilast and Prednisone|"Roflumilast 500 mcg will be administered orally daily for 21 consecutive days (a 21-day cycle).~In Cycle 1, prednisone 60 mg/m2 up to a maximum of 100 mg oral (PO) daily will be taken on Days 8 through 14 at the same time as roflumilast.~In Cycle 2 and subsequent cycles, prednisone 60 mg/m2 PO up to a maximum of 100 mg daily will be taken on Days 1 through 7 at the same time as roflumilast.~Prednisone: Patients may receive additional courses of treatment with prednisone (and roflumilast) at the discretion of the investigator if they did not experience unacceptable toxicity and have stable disease or objectively responding disease.~Roflumilast: Patients may receive additional courses of treatment with roflumilast (and prednisone) at the discretion of the investigator if they did not experience unacceptable toxicity, and have stable disease or objectively responding disease."
119840|NCT01888367|O3|Outcome|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
119841|NCT01888367|O2|Outcome|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Placebo Gel"
119842|NCT01888367|O1|Outcome|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Antibiotic Gel"
119808|NCT01888952|O1|Outcome|Roflumilast and Prednisone|"Roflumilast 500 mcg will be administered orally daily for 21 consecutive days (a 21-day cycle).~In Cycle 1, prednisone 60 mg/m2 up to a maximum of 100 mg oral (PO) daily will be taken on Days 8 through 14 at the same time as roflumilast.~In Cycle 2 and subsequent cycles, prednisone 60 mg/m2 PO up to a maximum of 100 mg daily will be taken on Days 1 through 7 at the same time as roflumilast.~Prednisone: Patients may receive additional courses of treatment with prednisone (and roflumilast) at the discretion of the investigator if they did not experience unacceptable toxicity and have stable disease or objectively responding disease.~Roflumilast: Patients may receive additional courses of treatment with roflumilast (and prednisone) at the discretion of the investigator if they did not experience unacceptable toxicity, and have stable disease or objectively responding disease."
119809|NCT01888952|E1|Reported Event|Roflumilast and Prednisone|"Roflumilast 500 mcg will be administered orally daily for 21 consecutive days (a 21-day cycle).~In Cycle 1, prednisone 60 mg/m2 up to a maximum of 100 mg oral (PO) daily will be taken on Days 8 through 14 at the same time as roflumilast.~In Cycle 2 and subsequent cycles, prednisone 60 mg/m2 PO up to a maximum of 100 mg daily will be taken on Days 1 through 7 at the same time as roflumilast.~Prednisone: Patients may receive additional courses of treatment with prednisone (and roflumilast) at the discretion of the investigator if they did not experience unacceptable toxicity and have stable disease or objectively responding disease.~Roflumilast: Patients may receive additional courses of treatment with roflumilast (and prednisone) at the discretion of the investigator if they did not experience unacceptable toxicity, and have stable disease or objectively responding disease."
119810|NCT01888900|B3|Baseline|Total|Total of all reporting groups
119811|NCT01888900|B2|Baseline|Hepatitis C Virus Genotype 1B|Patients will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
119812|NCT01888900|B1|Baseline|Hepatitis C Virus Genotype 1A|subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
119813|NCT01888900|P2|Participant Flow|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
119814|NCT01888900|P1|Participant Flow|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
119815|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
119816|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
119817|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
119818|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
119819|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
119820|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
119821|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
119822|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
119823|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
119824|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
119825|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
119826|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
119827|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
119828|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
119829|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Patients will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
119830|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Patients will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
119831|NCT01888900|E2|Reported Event|Hepatitis C Virus Genotype 1B|"subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks and undergo paired liver biopsies, pre-treatment and either at 2 or 4 weeks after starting therapy.~Asunaprevir and Daclatsvir"
119832|NCT01888900|E1|Reported Event|Hepatitis C Virus Genotype 1A|"Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.~Asunaprevir, daclatsvir, peginterferon, ribavirin"
119833|NCT01888367|B4|Baseline|Total|Total of all reporting groups
119834|NCT01888367|B3|Baseline|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
119835|NCT01888367|B2|Baseline|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Placebo Gel"
119836|NCT01888367|B1|Baseline|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Antibiotic Gel"
119837|NCT01888367|P3|Participant Flow|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
119838|NCT01888367|P2|Participant Flow|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Placebo Gel"
119839|NCT01888367|P1|Participant Flow|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Antibiotic Gel"
119843|NCT01888367|O3|Outcome|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
119844|NCT01888367|O2|Outcome|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Placebo Gel"
119845|NCT01888367|O1|Outcome|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Antibiotic Gel"
119846|NCT01888367|O3|Outcome|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
119847|NCT01888367|O2|Outcome|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Placebo Gel"
119848|NCT01888367|O1|Outcome|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Antibiotic Gel"
119849|NCT01888367|O3|Outcome|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
119850|NCT01888367|O2|Outcome|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Placebo Gel"
119851|NCT01888367|O1|Outcome|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Antibiotic Gel"
119852|NCT01888367|E3|Reported Event|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
119853|NCT01888367|E2|Reported Event|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Placebo Gel"
119854|NCT01888367|E1|Reported Event|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Antibiotic Gel"
119855|NCT01888003|B4|Baseline|Total|Total of all reporting groups
119856|NCT01888003|B3|Baseline|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
119857|NCT01888003|B2|Baseline|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
119858|NCT01888003|B1|Baseline|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.~Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.~Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
119859|NCT01888003|P3|Participant Flow|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
119860|NCT01888003|P2|Participant Flow|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
119879|NCT01887990|B3|Baseline|Suicidal, Depression and Opioid Use With Ketamine|"suicidal and depressed, opioid use 0.2 mg/kg IV ketamine administered as a one time dose~Ketamine"
119880|NCT01887990|B2|Baseline|Suicidal, Depression With Saline|"suicidal and depressed, no substance use comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
119881|NCT01887990|B1|Baseline|Suicidal, Depression With Ketamine|"suicidal and depressed, no substance use 0.2 mg/kg IV ketamine administered as a one time dose~Ketamine"
120661|NCT01882647|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
119861|NCT01888003|P1|Participant Flow|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.~Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.~Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
119862|NCT01888003|O3|Outcome|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
119863|NCT01888003|O2|Outcome|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
119864|NCT01888003|O1|Outcome|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.~Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.~Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
119865|NCT01888003|O3|Outcome|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
119866|NCT01888003|O2|Outcome|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
119867|NCT01888003|O1|Outcome|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.~Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.~Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
119868|NCT01888003|O3|Outcome|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
119882|NCT01887990|P4|Participant Flow|Suicidal, Depression With Opioid Use With Saline|suicidal, depression with opioid use, given saline IV
119883|NCT01887990|P3|Participant Flow|Suicidal, Depression and Opioid Use With Ketamine|suicidal, depressed with opioid use, given 0.2 mg/kg ketamine one time dose IV infusion
119884|NCT01887990|P2|Participant Flow|Suicidal, Depression With Saline|"comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
119869|NCT01888003|O2|Outcome|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
119870|NCT01888003|O1|Outcome|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.~Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.~Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
119871|NCT01888003|O3|Outcome|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
119872|NCT01888003|O2|Outcome|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
119873|NCT01888003|O1|Outcome|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.~Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.~Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
119874|NCT01888003|E3|Reported Event|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
119875|NCT01888003|E2|Reported Event|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
119876|NCT01888003|E1|Reported Event|Anemia Treatment Group (AMG)|"Patients diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.~Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.~Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days, −7 days before their planned surgery, and if indicated, based on labs, testing on the day of their surgery"
119877|NCT01887990|B5|Baseline|Total|Total of all reporting groups
119878|NCT01887990|B4|Baseline|Suicidal, Depression and Opioid Use With Ketamine|"suicidal and depressed,opioid use comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
119885|NCT01887990|P1|Participant Flow|Suicidal, Depression With Ketamine|"0.2 mg/kg IV ketamine administered as a one time dose in patients with suicidal ideatin and depression without substance use~Ketamine"
119886|NCT01887990|O4|Outcome|Suicidal, Opioid Use With Saline|suicidal patients who use opioids who received saline infusion or placebo
119887|NCT01887990|O3|Outcome|Suicidal, Opioid Use With Ketamine|suicidal pts who have used opioids, in the ketamine treatment arm
119888|NCT01887990|O2|Outcome|Suicidal, Depression With Saline|"comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
119889|NCT01887990|O1|Outcome|Suicidal, Depression With Ketamine|"0.2 mg/kg IV ketamine administered as a one time dose~Ketamine"
119890|NCT01887990|O4|Outcome|Suicidal, Opioid Use With Saline|Patients with suicidal ideation and depression with opioid use disorder who are given comparable amount of placebo (saline) as would have been used with the Ketamine arm
119891|NCT01887990|O3|Outcome|Suicidal, Opioid Use With Ketamine|suicidal ideation,depression, opioid use disorder 0.2 mg/kg IV ketamine one time dose
119892|NCT01887990|O2|Outcome|Suicidal, Depression With Saline|"comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
119893|NCT01887990|O1|Outcome|Suicidal, Depression With Ketamine|"0.2 mg/kg IV ketamine administered as a one time dose~Ketamine"
119894|NCT01887990|E4|Reported Event|Suicidal, Depression and Opioid With Saline|"Suicidal with depression and opioid use comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
119895|NCT01887990|E3|Reported Event|Suicidal, Depression and Opioid Use With Ketamine|"Suicidal with depression and opioid use 0.2 mg/kg IV ketamine administered as a one time dose~Ketamine"
119896|NCT01887990|E2|Reported Event|Suicidal, Depression With Saline|"Suicidal with depression and no substance use comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
119897|NCT01887990|E1|Reported Event|Suicidal, Depression With Ketamine|"Suicidal with depression and no substance use 0.2 mg/kg IV ketamine administered as a one time dose~Ketamine"
119898|NCT01887678|B3|Baseline|Total|Total of all reporting groups
119899|NCT01887678|B2|Baseline|Placebo Injectable Solution|At baseline, patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119900|NCT01887678|B1|Baseline|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119901|NCT01887678|P2|Participant Flow|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119902|NCT01887678|P1|Participant Flow|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119903|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119904|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119905|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119906|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119907|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119908|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119909|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119910|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119911|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119912|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119913|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119914|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119915|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119916|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119917|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119918|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119919|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119920|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119921|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119922|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119923|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119924|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119925|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119926|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119927|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119928|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119929|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119930|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119931|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119932|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119933|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119934|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119935|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119936|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119937|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119938|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119939|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119940|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119941|NCT01887678|E2|Reported Event|Placebo Injectable Solution|At baseline, patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119942|NCT01887678|E1|Reported Event|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
119943|NCT01887470|B5|Baseline|Total|Total of all reporting groups
119944|NCT01887470|B4|Baseline|Split Dose Preparation; PM Colonoscopy|Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated after noon.
119945|NCT01887470|B3|Baseline|Split Dose Preparation; AM Colonscopy|Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated prior to noon.
119946|NCT01887470|B2|Baseline|Full Dose Preparation: PM Colonoscopy|Four hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure. The colonoscopy is initiated after noon.
119947|NCT01887470|B1|Baseline|Full Dose Preparation; AM Colonoscopy|Four hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure. The colonoscopy is initiated prior to noon.
119948|NCT01887470|P4|Participant Flow|Split Dose Preparation; PM Colonoscopy|Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated after noon.
119949|NCT01887470|P3|Participant Flow|Split Dose Preparation; AM Colonoscopy|Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated prior to noon.
119950|NCT01887470|P2|Participant Flow|Full Dose Preparation; PM Colonoscopy|Four hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure. The colonoscopy is initiated after noon.
119951|NCT01887470|P1|Participant Flow|Full Dose Preparation; AM Colonoscopy|Four hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure. The colonoscopy is initiated prior to noon.
119952|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
119953|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
119954|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
119955|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
119956|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution
119957|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
119958|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
119959|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution
119960|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
119961|NCT01887470|O4|Outcome|Regimen B for PM Colonoscopy|"Regimen B for afternoon colonoscopy~Regimen B"
119962|NCT01887470|O3|Outcome|Regimen B for AM Colonoscopy|"Regimen B for morning colonoscopy~Regimen B"
119963|NCT01887470|O2|Outcome|Regimen A for PM Colonoscopy|"Regimen A for afternoon colonoscopy~Regimen A"
119964|NCT01887470|O1|Outcome|Regimen A for AM Colonoscopy|"Regimen A for morning colonoscopy~Regimen A"
119965|NCT01887470|E1|Reported Event|Lactulose for Oral Solution|All patients taking lactulose for oral solution were evaluated as one group for purposes of providing survey data on the use of the product as a bowel preparation agent for colonoscopy.
119966|NCT01887418|B4|Baseline|Total|Total of all reporting groups
119967|NCT01887418|B3|Baseline|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference~Delatestryl 200 mg IM Treatment C: injected once only"
119968|NCT01887418|B2|Baseline|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone once a week for 6 weeks"
119969|NCT01887418|B1|Baseline|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone once a week for 6 weeks"
119970|NCT01887418|P3|Participant Flow|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference~Delatestryl 200 mg IM Treatment C: injected once only"
119971|NCT01887418|P2|Participant Flow|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone once a week."
120037|NCT01886807|B1|Baseline|(DL Group)|direct laryngoscopy for nasotracheal intubation without oxygen insufflation
119972|NCT01887418|P1|Participant Flow|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone once a week"
119973|NCT01887418|O3|Outcome|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference~Delatestryl 200 mg IM Treatment C: Standard of care"
119974|NCT01887418|O2|Outcome|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone"
119975|NCT01887418|O1|Outcome|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone"
119976|NCT01887418|O3|Outcome|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference~Delatestryl 200 mg IM Treatment C: Standard of care"
119977|NCT01887418|O2|Outcome|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone"
119978|NCT01887418|O1|Outcome|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone"
119979|NCT01887418|O3|Outcome|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference~Delatestryl 200 mg IM Treatment C: Standard of care"
119980|NCT01887418|O2|Outcome|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone"
119981|NCT01887418|O1|Outcome|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone"
119982|NCT01887418|O3|Outcome|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference~Delatestryl 200 mg IM Treatment C: Standard of care"
119983|NCT01887418|O2|Outcome|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone"
119984|NCT01887418|O1|Outcome|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone"
119985|NCT01887418|E3|Reported Event|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference~Delatestryl 200 mg IM Treatment C: injected once only"
119986|NCT01887418|E2|Reported Event|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone once a week."
119987|NCT01887418|E1|Reported Event|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone once a week"
119988|NCT01887353|B3|Baseline|Total|Total of all reporting groups
119989|NCT01887353|B2|Baseline|Placebo|Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
119990|NCT01887353|B1|Baseline|Ranolazine|Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily
119991|NCT01887353|P2|Participant Flow|Placebo|Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
119992|NCT01887353|P1|Participant Flow|Ranolazine|Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily
119993|NCT01887353|O2|Outcome|Placebo|Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
119994|NCT01887353|O1|Outcome|Ranolazine|Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily
119995|NCT01887353|E2|Reported Event|Placebo|Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
119996|NCT01887353|E1|Reported Event|Ranolazine|Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily
119997|NCT01887288|B1|Baseline|Capecitabine With Digoxin|"Capecitabine PO daily b.i.d., no breaks, starts at day 1 of the first cycle; Digoxin: once daily, starts at day -7 of the first cycle~(1 cycle - 4 weeks)~Capecitabine: 650 mg/m^2 PO b.i.d.~Digoxin: 0.25 mg once daily"
119998|NCT01887288|P1|Participant Flow|Capecitabine With Digoxin|"Capecitabine PO daily b.i.d., no breaks, starts at day 1 of the first cycle; Digoxin: once daily, starts at day -7 of the first cycle~(1 cycle - 4 weeks)~Capecitabine: 650 mg/m^2 PO b.i.d.~Digoxin: 0.25 mg once daily"
119999|NCT01887288|O1|Outcome|Capecitabine With Digoxin|"Capecitabine PO daily b.i.d., no breaks, starts at day 1 of the first cycle; Digoxin: once daily, starts at day -7 of the first cycle~(1 cycle - 4 weeks)~Capecitabine: 650 mg/m^2 PO b.i.d.~Digoxin: 0.25 mg once daily"
120000|NCT01887288|O1|Outcome|Capecitabine With Digoxin|"Capecitabine PO daily b.i.d., no breaks, starts at day 1 of the first cycle; Digoxin: once daily, starts at day -7 of the first cycle~(1 cycle - 4 weeks)~Capecitabine: 650 mg/m^2 PO b.i.d.~Digoxin: 0.25 mg once daily"
120001|NCT01887288|E1|Reported Event|Capecitabine With Digoxin|"Capecitabine PO daily b.i.d., no breaks, starts at day 1 of the first cycle; Digoxin: once daily, starts at day -7 of the first cycle~(1 cycle - 4 weeks)~Capecitabine: 650 mg/m^2 PO b.i.d.~Digoxin: 0.25 mg once daily"
120002|NCT01887171|B3|Baseline|Total|Total of all reporting groups
120003|NCT01887171|B2|Baseline|HTK Only|During back-table operation 1000 ml of HTK solution cooled to 2-4˚C would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin under gravity pressure of 40 cm H2O.
120004|NCT01887171|B1|Baseline|Tacrolimus + HTK|"During back-table operation 1000 ml of HTK solution cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O.~Tacrolimus: 1000 ml of HTK solution (Custodiol, Dr. Franz Köhler Chemie GmBH) cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O."
120005|NCT01887171|P2|Participant Flow|HTK Solution Only|During back-table operation 1000 ml of HTK solution cooled to 2-4˚C would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin under gravity pressure of 40 cm H2O.
120006|NCT01887171|P1|Participant Flow|Tacrolimus + HTK|"During back-table operation 1000 ml of HTK solution cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O.~Tacrolimus: 1000 ml of HTK solution (Custodiol, Dr. Franz Köhler Chemie GmBH) cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O."
120007|NCT01887171|O2|Outcome|HTK Solution Only|During back-table operation 1000 ml of HTK solution cooled to 2-4˚C would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin under gravity pressure of 40 cm H2O.
120008|NCT01887171|O1|Outcome|Tacrolimus + HTK|"During back-table operation 1000 ml of HTK solution cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O.~Tacrolimus: 1000 ml of HTK solution (Custodiol, Dr. Franz Köhler Chemie GmBH) cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O."
120009|NCT01887171|E2|Reported Event|HTK Solution|During back-table operation 1000 ml of HTK solution cooled to 2-4˚C would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin under gravity pressure of 40 cm H2O.
120010|NCT01887171|E1|Reported Event|Tacrolimus + HTK|"During back-table operation 1000 ml of HTK solution cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O.~Tacrolimus: 1000 ml of HTK solution (Custodiol, Dr. Franz Köhler Chemie GmBH) cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O."
120011|NCT01887132|B1|Baseline|Open-Label Donepezil|Donepezil
120012|NCT01887132|P1|Participant Flow|Open-Label Donepezil|Donepezil
120013|NCT01887132|O1|Outcome|Open-Label Donepezil|Donepezil
120014|NCT01887132|O1|Outcome|Open-Label Donepezil|Donepezil
120015|NCT01887132|E1|Reported Event|Open-Label Donepezil|Donepezil
120016|NCT01886963|B3|Baseline|Total|Total of all reporting groups
120017|NCT01886963|B2|Baseline|SPY - Unblinded Use of SPY Elite|"Group B will have incision and advancement flap performed based on assessment of blood supply using the Spy Elite system, as well as potential flap revision if portions of the flap appear under-perfused in the pre-closure imaging. Patients will be blinded to if intraoperative Spy Elite imaging was used. Digital photographs of the surgical wound taken by surgical team daily until discharge, and on follow-up visits post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications (breakdown, necrosis, erythema, infection, or dehiscence with location specified) and assessment of healing. Upon study completion, groups will be compared for wound complications, presence of flap necrosis, quantification of flap necrosis, and healing speed.~VHR with Advancement Flaps with Unblinded Use of Spy Elite (Experimental): Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging"
120018|NCT01886963|B1|Baseline|Control - Blinded Use of SPY Elite|"Group A will consist of intraoperative abdominal wall imaging prior to incision, followed by ventral hernia repair with subcutaneous advancement flaps without viewing the imaging contained within the Spy Elite system. A digital photograph will be taken before and immediately after initial incision, as well as immediately prior to and after closure. The patient will have digital photographs of the surgical wound taken by the surgical team daily until discharge, and on follow-up visits at one week, two weeks, four weeks and twelve weeks. After twenty patients have completed phase I, the surgical team will be unblinded to Spy Elite imaging. The Spy Elite imaging and all digital photographs of all patients will be reviewed.~Ventral Hernia Repair with Advancement Flaps with Blinded Use of Spy Elite (Control): Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone"
120019|NCT01886963|P2|Participant Flow|Control - Blinded Use of SPY Elite|"Control - Blinded use of SPY Elite will consist of intraoperative abdominal wall imaging prior to incision, followed by ventral hernia repair with subcutaneous advancement flaps without viewing the imaging contained within the Spy Elite system. A digital photograph will be taken before and immediately after initial incision, as well as immediately prior to and after closure. The patient will have digital photographs of the surgical wound taken by the surgical team daily until discharge, and on follow-up visits at one week, two weeks, four weeks and twelve weeks. After twenty patients have completed phase I, the surgical team will be unblinded to Spy Elite imaging. The Spy Elite imaging and all digital photographs of all patients will be reviewed.~Control - Blinded Use of Spy Elite: Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone"
120038|NCT01886807|P3|Participant Flow|(VL Group)|nasotracheal intubation using the Truview PCD video laryngoscope
120039|NCT01886807|P2|Participant Flow|(DL-O2 Group)|direct laryngoscopy for nasotracheal intubation with oxygen insufflation
120040|NCT01886807|P1|Participant Flow|(DL Group)|direct laryngoscopy for nasotracheal intubation without oxygen insufflation
120041|NCT01886807|O3|Outcome|(VL Group)|"nasotracheal intubation using the Truview PCD video laryngoscope~TrueView PCD Video Laryngoscope"
120042|NCT01886807|O2|Outcome|(DL-O2 Group)|"direct laryngoscopy for nasotracheal intubation with oxygen insufflation~TrueView PCD Video Laryngoscope"
120020|NCT01886963|P1|Participant Flow|SPY - Unblinded Use of SPY Elite|"SPY - Unblinded use of SPY Elite will have incision and advancement flap performed based on assessment of blood supply using the Spy Elite system, as well as potential flap revision if portions of the flap appear under-perfused in the pre-closure imaging. Patients will be blinded to if intraoperative Spy Elite imaging was used. Digital photographs of the surgical wound taken by surgical team daily until discharge, and on follow-up visits post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications (breakdown, necrosis, erythema, infection, or dehiscence with location specified) and assessment of healing. Upon study completion, groups will be compared for wound complications, presence of flap necrosis, quantification of flap necrosis, and healing speed.~SPY - Unblinded Use of Spy Elite: Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging"
120021|NCT01886963|O2|Outcome|Group B|"Group B will have incision and advancement flap performed based on assessment of blood supply using the Spy Elite system, as well as potential flap revision if portions of the flap appear under-perfused in the pre-closure imaging. Patients will be blinded to if intraoperative Spy Elite imaging was used. Digital photographs of the surgical wound taken by surgical team daily until discharge, and on follow-up visits post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications (breakdown, necrosis, erythema, infection, or dehiscence with location specified) and assessment of healing. Upon study completion, groups will be compared for wound complications, presence of flap necrosis, quantification of flap necrosis, and healing speed.~VHR with Advancement Flaps with Unblinded Use of Spy Elite (Experimental): Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging"
120022|NCT01886963|O1|Outcome|Group A|"Group A will consist of intraoperative abdominal wall imaging prior to incision, followed by ventral hernia repair with subcutaneous advancement flaps without viewing the imaging contained within the Spy Elite system. A digital photograph will be taken before and immediately after initial incision, as well as immediately prior to and after closure. The patient will have digital photographs of the surgical wound taken by the surgical team daily until discharge, and on follow-up visits at one week, two weeks, four weeks and twelve weeks. After twenty patients have completed phase I, the surgical team will be unblinded to Spy Elite imaging. The Spy Elite imaging and all digital photographs of all patients will be reviewed.~Ventral Hernia Repair with Advancement Flaps with Blinded Use of Spy Elite (Control): Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone"
120023|NCT01886963|E2|Reported Event|Control - Blinded Use of SPY Elite|"Control - Blinded use of SPY Elite will consist of intraoperative abdominal wall imaging prior to incision, followed by ventra l hernia repair with subcutaneous advancement flaps without viewing the imaging contained within the Spy Elite system. A digital photograph will be taken before and immediately after initial incision, as well as immediately prior to and after closure. The patient will have digital photographs of the surgical wound taken by the surgical team daily until discharge, and on follow-up visits at one week, two weeks, four weeks and twelve weeks. After twenty patients have completed phase I, the surgical team will be unblinded to Spy Elite imaging. The Spy Elite imaging and all digital photographs of all patients will be reviewed.~Control - Blinded Use of Spy Elite: Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone"
120024|NCT01886963|E1|Reported Event|SPY - Unblinded Use of SPY Elite|"SPY - Unblinded use of SPY Elite will have incision and advancement flap performed based on assessment of blood supply using the Spy Elite system, as well as potential flap revision if portions of the flap appear under-perfused in the pre-closure imaging. Patients will be blinded to if intraoperative Spy Elite imaging was used. Digital photographs of the surgical wound taken by surgical team daily until discharge, and on follow-up visits post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications (breakdown, necrosis, erythema, infection, or dehiscence with location specified) and assessment of healing. Upon study completion, groups will be compared for wound complications, presence of flap necrosis, quantification of flap necrosis, and healing speed.~SPY - Unblinded use of Spy Elite: Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging"
120025|NCT01886937|B3|Baseline|Total|Total of all reporting groups
120026|NCT01886937|B2|Baseline|Placebo First, Then 37.5mg Phentermine|"In this arm, participants receive Placebo (for 37.5mg phentermine) for two weeks followed by phentermine 37.5mg for 7 days.~placebo: Food intake as measured by a laboratory study should be greater after 7 days of placebo administration compared to seven days of phentermine administration."
120027|NCT01886937|B1|Baseline|37.5 mg Phentermine First, Then Placebo|"In this arm, participants receive 37.5mg phentermine for one week followed by 2 weeks of placebo.~Other names for phentermine:~adipex ionamin~Phentermine: After 7 days of phentermine 37.5 mg administration, food intake should be less than after 14 days of placebo."
120028|NCT01886937|P2|Participant Flow|Placebo (for Phentermine 37.5mg) First, Followed by Phentermin|"In this arm, participants receive Placebo (for 37.5mg phentermine) for two weeks followed by phentermine 37.5mg for 7 days.~placebo: Food intake as measured by a laboratory study should be greater after 7 days of placebo administration compared to seven days of phentermine administration."
120029|NCT01886937|P1|Participant Flow|37.5 mg Phentermine Daily for 7 Days First,Followed by Placebo|"In this arm, participants receive 37.5mg phentermine for one week followed by 2 weeks of placebo.~Other names for phentermine:~adipex ionamin~Phentermine: After 7 days of phentermine 37.5 mg administration, food intake should be less than after 14 days of placebo."
120030|NCT01886937|O2|Outcome|Placebo (for Phentermine 37.5mg)|"In this arm, participants receive Placebo (for 37.5mg phentermine) for 7 days.~placebo: Food intake as measured by a laboratory study should be greater after 7 days of placebo administration compared to seven days of phentermine administration."
120031|NCT01886937|O1|Outcome|37.5 mg Phentermine Daily for 7 Days|"In this arm, participants receive 37.5mg phentermine for one week .~Other names for phentermine:~adipex ionamin~Phentermine: After 7 days of phentermine 37.5 mg administration, food intake should be less than after 14 days of placebo."
120032|NCT01886937|E2|Reported Event|Placebo|This group refers to all participants who received Placebo.
120033|NCT01886937|E1|Reported Event|37.5 mg Phentermine|"This describes all participants who received 37.5mg phentermine for one week.~Other names for phentermine:~adipex ionamin"
120034|NCT01886807|B4|Baseline|Total|Total of all reporting groups
120035|NCT01886807|B3|Baseline|(VL Group)|nasotracheal intubation using the Truview PCD video laryngoscope
120036|NCT01886807|B2|Baseline|(DL-O2 Group)|direct laryngoscopy for nasotracheal intubation with oxygen insufflation
120043|NCT01886807|O1|Outcome|(DL Group)|"direct laryngoscopy for nasotracheal intubation without oxygen insufflation~TrueView PCD Video Laryngoscope"
120044|NCT01886807|E3|Reported Event|(VL Group)|nasotracheal intubation using the Truview PCD video laryngoscope
120045|NCT01886807|E2|Reported Event|(DL-O2 Group)|direct laryngoscopy for nasotracheal intubation with oxygen insufflation
120046|NCT01886807|E1|Reported Event|(DL Group)|direct laryngoscopy for nasotracheal intubation without oxygen insufflation
120047|NCT01886781|B3|Baseline|Total|Total of all reporting groups
120048|NCT01886781|B2|Baseline|Placebo|Controls Crytalline cellulose powder
120049|NCT01886781|B1|Baseline|Lactobacillus Plantarum 299v|Treatment Lactobacillus plantarum 299v
120050|NCT01886781|P2|Participant Flow|Placebo|Controls Crytalline cellulose powder
120051|NCT01886781|P1|Participant Flow|Lactobacillus Plantarum 299v|Treatment Lactobacillus plantarum 299v
120052|NCT01886781|O2|Outcome|Placebo|Controls Crytalline cellulose powder
120053|NCT01886781|O1|Outcome|Lactobacillus Plantarum 299v|Treatment Lactobacillus plantarum 299v
120054|NCT01886781|E2|Reported Event|Placebo|Controls Crytalline cellulose powder
120055|NCT01886781|E1|Reported Event|Lactobacillus Plantarum 299v|Treatment Lactobacillus plantarum 299v
120056|NCT01886716|B5|Baseline|Total|Total of all reporting groups
120057|NCT01886716|B4|Baseline|Control Training|"Participants will receive placebo Anxiety Training and placebo Alcohol training.~Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol."
120058|NCT01886716|B3|Baseline|Anxiety + Alcohol Attention Training|"Participants will receive both Anxiety Attention Training and Alcohol Attention Training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
120059|NCT01886716|B2|Baseline|Alcohol Attention Training Only|"Participants will receive Alcohol Attention Training and placebo Anxiety training.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
120060|NCT01886716|B1|Baseline|Anxiety Attention Training Only|"Participants will receive Anxiety Attention Training and placebo Alcohol training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety."
120061|NCT01886716|P4|Participant Flow|Control Training|"Participants will receive placebo Anxiety Training and placebo Alcohol training.~Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol."
120062|NCT01886716|P3|Participant Flow|Anxiety + Alcohol Attention Training|"Participants will receive both Anxiety Attention Training and Alcohol Attention Training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
120063|NCT01886716|P2|Participant Flow|Alcohol Attention Training Only|"Participants will receive Alcohol Attention Training and placebo Anxiety training.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
120064|NCT01886716|P1|Participant Flow|Anxiety Attention Training Only|"Participants will receive Anxiety Attention Training and placebo Alcohol training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety."
120065|NCT01886716|O4|Outcome|Control Training|"Participants will receive placebo Anxiety Training and placebo Alcohol training.~Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol."
120066|NCT01886716|O3|Outcome|Anxiety + Alcohol Attention Training|"Participants will receive both Anxiety Attention Training and Alcohol Attention Training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
120067|NCT01886716|O2|Outcome|Alcohol Attention Training Only|"Participants will receive Alcohol Attention Training and placebo Anxiety training.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
120068|NCT01886716|O1|Outcome|Anxiety Attention Training Only|"Participants will receive Anxiety Attention Training and placebo Alcohol training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety."
120069|NCT01886716|O4|Outcome|Control Training|"Participants will receive placebo Anxiety Training and placebo Alcohol training.~Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol."
120070|NCT01886716|O3|Outcome|Anxiety + Alcohol Attention Training|"Participants will receive both Anxiety Attention Training and Alcohol Attention Training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
120071|NCT01886716|O2|Outcome|Alcohol Attention Training Only|"Participants will receive Alcohol Attention Training and placebo Anxiety training.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
120072|NCT01886716|O1|Outcome|Anxiety Attention Training Only|"Participants will receive Anxiety Attention Training and placebo Alcohol training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety."
120073|NCT01886716|E4|Reported Event|Control Training|"Participants will receive placebo Anxiety Training and placebo Alcohol training.~Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol."
120113|NCT01886300|E1|Reported Event|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
136515|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
120074|NCT01886716|E3|Reported Event|Anxiety + Alcohol Attention Training|"Participants will receive both Anxiety Attention Training and Alcohol Attention Training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
120075|NCT01886716|E2|Reported Event|Alcohol Attention Training Only|"Participants will receive Alcohol Attention Training and placebo Anxiety training.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
120076|NCT01886716|E1|Reported Event|Anxiety Attention Training Only|"Participants will receive Anxiety Attention Training and placebo Alcohol training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety."
120077|NCT01886690|B3|Baseline|Total|Total of all reporting groups
120078|NCT01886690|B2|Baseline|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
120079|NCT01886690|B1|Baseline|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
120080|NCT01886690|P2|Participant Flow|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
120081|NCT01886690|P1|Participant Flow|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
120082|NCT01886690|O2|Outcome|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
120083|NCT01886690|O1|Outcome|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
120084|NCT01886690|O2|Outcome|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
120085|NCT01886690|O1|Outcome|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
120086|NCT01886690|O2|Outcome|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
120087|NCT01886690|O1|Outcome|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
120088|NCT01886690|O2|Outcome|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
120089|NCT01886690|O1|Outcome|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
120090|NCT01886690|O2|Outcome|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
120091|NCT01886690|O1|Outcome|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
120092|NCT01886690|E2|Reported Event|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
120093|NCT01886690|E1|Reported Event|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
120094|NCT01886313|B3|Baseline|Total|Total of all reporting groups
120095|NCT01886313|B2|Baseline|Double Blind Treatment Period Placebo Nasal Spray|"Placebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks~Placebo"
120096|NCT01886313|B1|Baseline|Double Blind Treatment Period Civamide Nasal Spray|"Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks~Civamide Nasal Spray"
120097|NCT01886313|P2|Participant Flow|Double Blind Treatment Period Placebo Nasal Spray|"Placebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks~Placebo"
120098|NCT01886313|P1|Participant Flow|Double Blind Treatment Period Civamide Nasal Spray|"Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks~Civamide Nasal Spray"
120099|NCT01886313|O2|Outcome|Double Blind Treatment Period Placebo Nasal Spray|"Placebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks~Placebo"
120100|NCT01886313|O1|Outcome|Double Blind Treatment Period Civamide Nasal Spray|"Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks~Civamide Nasal Spray"
120101|NCT01886313|E2|Reported Event|Double Blind Treatment Period Placebo Nasal Spray|"Placebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks~Placebo"
120102|NCT01886313|E1|Reported Event|Double Blind Treatment Period Civamide Nasal Spray|"Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks~Civamide Nasal Spray"
120103|NCT01886300|B1|Baseline|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
120104|NCT01886300|P1|Participant Flow|Peginterferon Alfa-2a|Participants with hepatitis B envelope antigen (HBeAg) positive chronic hepatitis B who received peginterferon alfa-2a [Pegasys] were included.
120105|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
120106|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
120107|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
120108|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
120109|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
120110|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
120111|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
120112|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
120409|NCT01884545|O4|Outcome|Non-Genetic Risk Counseling|Patients who did not receive genetic risk counseling
120114|NCT01886287|B1|Baseline|Octreotide Long-acting Release (LAR)|"Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.~Octreotide LAR: Octreotide LAR as outlined in Treatment Arm."
120115|NCT01886287|P1|Participant Flow|Octreotide Long-acting Release (LAR)|"Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.~Octreotide LAR: Octreotide LAR as outlined in Treatment Arm."
120116|NCT01886287|O1|Outcome|Octreotide Long-acting Release (LAR)|"Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.~Octreotide LAR: Octreotide LAR as outlined in Treatment Arm."
120117|NCT01886287|O1|Outcome|Octreotide Long-acting Release (LAR)|"Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.~Octreotide LAR: Octreotide LAR as outlined in Treatment Arm."
120118|NCT01886287|E1|Reported Event|Octreotide Long-acting Release (LAR)|"Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.~Octreotide LAR: Octreotide LAR as outlined in Treatment Arm."
120119|NCT01886235|B1|Baseline|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.~Diagnostic Microscopy: Undergo intravital microscopy~Fluorescein Sodium Injection: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
120120|NCT01886235|P1|Participant Flow|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.~Diagnostic Microscopy: Undergo intravital microscopy~Fluorescein Sodium Injection: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
120121|NCT01886235|O1|Outcome|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.~Diagnostic Microscopy: Undergo intravital microscopy~Fluorescein Sodium Injection: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
120122|NCT01886235|O1|Outcome|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.~Diagnostic Microscopy: Undergo intravital microscopy~Fluorescein Sodium Injection: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
120123|NCT01886235|O1|Outcome|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.~Diagnostic Microscopy: Undergo intravital microscopy~Fluorescein Sodium Injection: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
120124|NCT01886235|O1|Outcome|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.~Diagnostic Microscopy: Undergo intravital microscopy~Fluorescein Sodium Injection: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
120125|NCT01886235|O1|Outcome|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.~Diagnostic Microscopy: Undergo intravital microscopy~Fluorescein Sodium Injection: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
120126|NCT01886235|O1|Outcome|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.~Diagnostic Microscopy: Undergo intravital microscopy~Fluorescein Sodium Injection: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
120127|NCT01886235|O1|Outcome|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.~Diagnostic Microscopy: Undergo intravital microscopy~Fluorescein Sodium Injection: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
120128|NCT01886235|O1|Outcome|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.~Diagnostic Microscopy: Undergo intravital microscopy~Fluorescein Sodium Injection: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
120129|NCT01886235|E1|Reported Event|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.~Diagnostic Microscopy: Undergo intravital microscopy~Fluorescein Sodium Injection: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
120130|NCT01885936|B3|Baseline|Total|Total of all reporting groups
120131|NCT01885936|B2|Baseline|Placebo Comparator|Placebo administered
120132|NCT01885936|B1|Baseline|Albuterol|Initially 4 mg daily for one week, 4 mg BID per oral daily for the next 5 weeks. If the 4 mg BID per oral is well tolerated, the dose will be increased to 8 mg each morning/4 mg each evening for one week, followed by 8 mg BID per oral for the remainder of the study.
120133|NCT01885936|P2|Participant Flow|Placebo Comparator|Placebo administered
120134|NCT01885936|P1|Participant Flow|Albuterol|Initially 4 mg daily for one week, 4 mg BID (twice a day) per oral for the next 5 weeks. If the 4 mg BID per oral is well tolerated, the dose will be increased to 8 mg each morning/4 mg each evening for one week, followed by 8 mg BID per oral for the remainder of the study.
120135|NCT01885936|O2|Outcome|Placebo Comparator|Placebo administered
120136|NCT01885936|O1|Outcome|Albuterol|Initially 4 mg daily for one week, 4 mg BID per oral daily for the next 5 weeks. If the 4 mg BID per oral is well tolerated, the dose will be increased to 8 mg each morning/4 mg each evening for one week, followed by 8 mg BID per oral for the remainder of the study.
120137|NCT01885936|O2|Outcome|Placebo Comparator|Placebo administered
120138|NCT01885936|O1|Outcome|Albuterol|Initially 4 mg daily for one week, 4 mg BID per oral daily for the next 5 weeks. If the 4 mg BID per oral is well tolerated, the dose will be increased to 8 mg each morning/4 mg each evening for one week, followed by 8 mg BID per oral for the remainder of the study.
120139|NCT01885936|O2|Outcome|Placebo Comparator|Placebo administered
120410|NCT01884545|O3|Outcome|Genetic Risk Counseling|Patients who received genetic risk counseling
120140|NCT01885936|O1|Outcome|Albuterol|Initially 4 mg daily for one week, 4 mg BID per oral daily for the next 5 weeks. If the 4 mg BID per oral is well tolerated, the dose will be increased to 8 mg each morning/4 mg each evening for one week, followed by 8 mg BID per oral for the remainder of the study.
120141|NCT01885936|E2|Reported Event|Placebo Comparator|Placebo administered
120142|NCT01885936|E1|Reported Event|Albuterol|Initially 4 mg daily for one week, 4 mg BID per oral daily for the next 5 weeks. If the 4 mg BID per oral is well tolerated, the dose will be increased to 8 mg each morning/4 mg each evening for one week, followed by 8 mg BID per oral for the remainder of the study.
120143|NCT01885910|B1|Baseline|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
120144|NCT01885910|P1|Participant Flow|Doxy + Aczone|"Subjects will start treatment with doxycycline 100mg once daily and Aczone 5% gel applied to the face twice daily~Doxycycline 100mg and Aczone 5% gel: Subject is to take Doxycycline 100mg by mouth once daily and apply Aczone 5% gel to their face twice daily for 12 weeks; those subjects achieving treatment response will stop Doxycycline and continue applying Aczone 5% gel twice daily for 12 more weeks."
120145|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
120146|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
120147|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
120148|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
120149|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
120150|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
120151|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
120152|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
120153|NCT01885910|O2|Outcome|Aczone/Doxy - Non Inflammatory|non inflammatory lesion counts during treatment with aczone 5% and doxy 100mg
120154|NCT01885910|O1|Outcome|Aczone/Doxy - Inflammatory|inflammatory lesion counts during treatment with aczone 5% and doxycycline 100mg
120155|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
120156|NCT01885910|E1|Reported Event|Doxy + Aczone|"Subjects will start treatment with doxycycline 100mg once daily and Aczone 5% gel applied to the face twice daily~Doxycycline 100mg and Aczone 5% gel: Subject is to take Doxycycline 100mg by mouth once daily and apply Aczone 5% gel to their face twice daily for 12 weeks; those subjects achieving treatment response will stop Doxycycline and continue applying Aczone 5% gel twice daily for 12 more weeks."
120157|NCT01885871|B1|Baseline|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
120158|NCT01885871|P1|Participant Flow|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
120159|NCT01885871|O1|Outcome|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
120160|NCT01885871|O1|Outcome|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
120161|NCT01885871|O1|Outcome|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
120162|NCT01885871|O1|Outcome|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
120163|NCT01885871|O1|Outcome|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
120164|NCT01885871|E1|Reported Event|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
120165|NCT01885559|B3|Baseline|Total|Total of all reporting groups
120166|NCT01885559|B2|Baseline|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
120167|NCT01885559|B1|Baseline|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
120168|NCT01885559|P2|Participant Flow|ACE-I + Angiotensin Receptor Blocker (ARB)|"ACE-I + angiotensin receptor blocker (ARB) and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
120225|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
120169|NCT01885559|P1|Participant Flow|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
120170|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
120171|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
120172|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
120173|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
120174|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
120175|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
120176|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
120177|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
120178|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
120179|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
120180|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
120181|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
120182|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
120183|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
120184|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
120185|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
120186|NCT01885559|E2|Reported Event|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
120187|NCT01885559|E1|Reported Event|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
120188|NCT01885208|B3|Baseline|Total|Total of all reporting groups
120189|NCT01885208|B2|Baseline|Exenatide ER 2.0 mg|Subjects randomised to exenatide extended release (ER) 2.0 mg (Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.
120226|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
120227|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
120265|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
120190|NCT01885208|B1|Baseline|Semaglutide 1.0 mg|Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD) therapy throughout the trial, unless rescue medication was needed.
120191|NCT01885208|P2|Participant Flow|Exenatide ER 2.0 mg|Subjects on exenatide extended release (ER) 2.0 mg (Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.
120192|NCT01885208|P1|Participant Flow|Semaglutide 1.0 mg|Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD) therapy throughout the trial, unless rescue medication was needed.
120193|NCT01885208|O2|Outcome|Exenatide ER 2.0 mg|Subjects randomised to exenatide extended release (ER) 2.0 mg (Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.
120194|NCT01885208|O1|Outcome|Semaglutide 1.0 mg|Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD) therapy throughout the trial, unless rescue medication was needed.
120195|NCT01885208|O2|Outcome|Exenatide ER 2.0 mg|Subjects randomised to exenatide extended release (ER) 2.0 mg (Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.
120196|NCT01885208|O1|Outcome|Semaglutide 1.0 mg|Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD) therapy throughout the trial, unless rescue medication was needed.
120197|NCT01885208|O2|Outcome|Exenatide ER 2.0 mg|Subjects randomised to exenatide extended release (ER) 2.0 mg (Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.
120198|NCT01885208|O1|Outcome|Semaglutide 1.0 mg|Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD) therapy throughout the trial, unless rescue medication was needed.
120199|NCT01885208|O2|Outcome|Exenatide ER 2.0 mg|Subjects randomised to exenatide extended release (ER) 2.0 mg (Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.
120200|NCT01885208|O1|Outcome|Semaglutide 1.0 mg|Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD) therapy throughout the trial, unless rescue medication was needed.
120201|NCT01885208|O2|Outcome|Exenatide ER 2.0 mg|Subjects randomised to exenatide extended release (ER) 2.0 mg (Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.
120411|NCT01884545|O2|Outcome|Non-Health Coaching|Participants who did not receive health coaching
120202|NCT01885208|O1|Outcome|Semaglutide 1.0 mg|Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD) therapy throughout the trial, unless rescue medication was needed.
120203|NCT01885208|O2|Outcome|Exenatide ER 2.0 mg|Subjects randomised to exenatide extended release (ER) 2.0 mg (Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.
120204|NCT01885208|O1|Outcome|Semaglutide 1.0 mg|Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD) therapy throughout the trial, unless rescue medication was needed.
120205|NCT01885208|E2|Reported Event|Exenatide ER|Subjects randomised to exenatide extended release (ER) 2.0 mg(Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.
120206|NCT01885208|E1|Reported Event|Sema 1.0 mg|Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD)therapy throughout the trial, unless rescue medication was needed.
120207|NCT01885117|B3|Baseline|Total|Total of all reporting groups
120208|NCT01885117|B2|Baseline|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
120209|NCT01885117|B1|Baseline|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
120210|NCT01885117|P2|Participant Flow|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
120211|NCT01885117|P1|Participant Flow|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
120212|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
120213|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
120214|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
120215|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
120216|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
120217|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
120218|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
120219|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
120220|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
120221|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
120222|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
120223|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
120224|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
136516|NCT01806857|O2|Outcome|Matching Placebo|
120228|NCT01885117|E2|Reported Event|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
120229|NCT01885117|E1|Reported Event|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
120230|NCT01885104|B3|Baseline|Total|Total of all reporting groups
120231|NCT01885104|B2|Baseline|Placebo|Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
120232|NCT01885104|B1|Baseline|PEG 3350|Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
120233|NCT01885104|P2|Participant Flow|Placebo|Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
120234|NCT01885104|P1|Participant Flow|PEG 3350|Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
120235|NCT01885104|O2|Outcome|Placebo|Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
120236|NCT01885104|O1|Outcome|PEG 3350|Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
120237|NCT01885104|O2|Outcome|Placebo|Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
120238|NCT01885104|O1|Outcome|PEG 3350|Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
120239|NCT01885104|E2|Reported Event|Placebo|Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
120240|NCT01885104|E1|Reported Event|PEG 3350|Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
120241|NCT01885000|B3|Baseline|Total|Total of all reporting groups
120242|NCT01885000|B2|Baseline|Vehicle|once-daily brimonidine tartrate vehicle gel
120243|NCT01885000|B1|Baseline|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
120244|NCT01885000|P2|Participant Flow|Vehicle|once-daily brimonidine tartrate vehicle gel
120245|NCT01885000|P1|Participant Flow|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
120246|NCT01885000|O2|Outcome|Vehicle|once-daily brimonidine tartrate vehicle gel
120247|NCT01885000|O1|Outcome|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
120248|NCT01885000|O2|Outcome|Vehicle|once-daily brimonidine tartrate vehicle gel
120249|NCT01885000|O1|Outcome|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
120250|NCT01885000|O2|Outcome|Vehicle|once-daily brimonidine tartrate vehicle gel
120251|NCT01885000|O1|Outcome|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
120252|NCT01885000|O2|Outcome|Vehicle|once-daily brimonidine tartrate vehicle gel
120253|NCT01885000|O1|Outcome|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
120254|NCT01885000|E2|Reported Event|Vehicle|once-daily brimonidine tartrate vehicle gel
120255|NCT01885000|E1|Reported Event|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
120256|NCT01884688|B1|Baseline|ENK Cell Infusion|"Expanded Natural Killer Cell Infusion~ENK Cell Infusion: Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU"
120257|NCT01884688|P1|Participant Flow|ENK Cell Infusion|"Expanded Natural Killer Cell Infusion~ENK Cell Infusion: Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU"
120258|NCT01884688|O1|Outcome|ENK Cell Infusion|"Expanded Natural Killer Cell Infusion~ENK Cell Infusion: Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU"
120259|NCT01884688|E1|Reported Event|ENK Cell Infusion|"Expanded Natural Killer Cell Infusion~ENK Cell Infusion: Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU"
120260|NCT01884675|B3|Baseline|Total|Total of all reporting groups
120261|NCT01884675|B2|Baseline|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
120262|NCT01884675|B1|Baseline|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
120263|NCT01884675|P2|Participant Flow|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
136517|NCT01806857|O1|Outcome|Active Drug (Neudexta)|
120267|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
120268|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
120269|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
120270|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.c
120271|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
120272|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
120273|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
120274|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
120275|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
120276|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
120277|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
120278|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
120279|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
120280|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
120281|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
120282|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
120283|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
120284|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
120285|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
120286|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
120287|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
120288|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
120289|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
120290|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
120291|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
120292|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
120293|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
120294|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
120295|NCT01884675|O2|Outcome|Ambrisentan 5mg|Subjects in this arm will receive ambrisentan-matching placebo tablet once daily during the treatment period.
120296|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
120297|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
120298|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
120299|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
120300|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
120301|NCT01884675|E2|Reported Event|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
120302|NCT01884675|E1|Reported Event|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
120303|NCT01884597|B4|Baseline|Total|Total of all reporting groups
120304|NCT01884597|B3|Baseline|Cohort 3|"12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab~high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120305|NCT01884597|B2|Baseline|Cohort 2|"6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg~high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120306|NCT01884597|B1|Baseline|Cohort 1|"24 months of monthly, intravitreal injections of ranibizumab 1.0mg~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120307|NCT01884597|P3|Participant Flow|Cohort 3|"12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab~high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120308|NCT01884597|P2|Participant Flow|Cohort 2|"6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg~high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120309|NCT01884597|P1|Participant Flow|Cohort 1|"24 months of monthly, intravitreal injections of ranibizumab 1.0mg~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120336|NCT01884597|E1|Reported Event|Cohort 1|"24 months of monthly, intravitreal injections of ranibizumab 1.0mg~ranibizumab: 3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120310|NCT01884597|O3|Outcome|Cohort 3|"12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab~high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120311|NCT01884597|O2|Outcome|Cohort 2|"6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg~high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120312|NCT01884597|O1|Outcome|Cohort 1|"24 months of monthly, intravitreal injections of ranibizumab 1.0mg~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120313|NCT01884597|O3|Outcome|Cohort 3|"12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab~high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120314|NCT01884597|O2|Outcome|Cohort 2|"6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg~high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120315|NCT01884597|O1|Outcome|Cohort 1|"24 months of monthly, intravitreal injections of ranibizumab 1.0mg~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120316|NCT01884597|O3|Outcome|Cohort 3|"12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab~high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120317|NCT01884597|O2|Outcome|Cohort 2|"6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg~high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120318|NCT01884597|O1|Outcome|Cohort 1|"24 months of monthly, intravitreal injections of ranibizumab 1.0mg~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120319|NCT01884597|O3|Outcome|Cohort 3|"12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab~high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120320|NCT01884597|O2|Outcome|Cohort 2|"6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg~high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120321|NCT01884597|O1|Outcome|Cohort 1|"24 months of monthly, intravitreal injections of ranibizumab 1.0mg~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120322|NCT01884597|O3|Outcome|Cohort 3|"12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab~high-dose ranibizumab: 20mg ranibizumab vials, 0.05ml injected intravitreally, monthly~ranibizumab: 3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120323|NCT01884597|O2|Outcome|Cohort 2|"6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg~high-dose ranibizumab: 20mg ranibizumab vials, 0.05ml injected intravitreally, monthly~ranibizumab: 3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120324|NCT01884597|O1|Outcome|Cohort 1|"24 months of monthly, intravitreal injections of ranibizumab 1.0mg~ranibizumab: 3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120325|NCT01884597|O3|Outcome|Cohort 3|No ocular adverse events
120326|NCT01884597|O2|Outcome|Cohort 2|No ocular adverse events
120327|NCT01884597|O1|Outcome|Cohort 1|No ocular adverse events
120328|NCT01884597|O3|Outcome|Cohort 3|"12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab~high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120329|NCT01884597|O2|Outcome|Cohort 2|"6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg~high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120330|NCT01884597|O1|Outcome|Cohort 1|"24 months of monthly, intravitreal injections of ranibizumab 1.0mg~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120331|NCT01884597|O3|Outcome|Cohort 3|"12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab~high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120332|NCT01884597|O2|Outcome|Cohort 2|"6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg~high-dose ranibizumab: 2.0mg/0.05ml ranibizumab, 0.05ml injected intravitreally, monthly~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120333|NCT01884597|O1|Outcome|Cohort 1|"24 months of monthly, intravitreal injections of ranibizumab 1.0mg~ranibizumab: 1 mg/0.1 ml ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120334|NCT01884597|E3|Reported Event|Cohort 3|"12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab~high-dose ranibizumab: 20mg ranibizumab vials, 0.05ml injected intravitreally, monthly~ranibizumab: 3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
120335|NCT01884597|E2|Reported Event|Cohort 2|"6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg~high-dose ranibizumab: 20mg ranibizumab vials, 0.05ml injected intravitreally, monthly~ranibizumab: 3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly"
136518|NCT01806857|O2|Outcome|Matching Placebo|
120337|NCT01884571|B1|Baseline|Immunosuppression Regimen|All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months.
120338|NCT01884571|P1|Participant Flow|Immunosuppression Regimen|"All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment (described below) and the treatment period lasted for six months.~Basiliximab: 20 mg, IV (in the vein) on day 1 and 4.~Methylprednisolone: 125 mg, IV (in the vein) on day 1.~Prednisone: 60 mg PO (by mouth) on days 2-7, 40 mg PO days 8-14, 20 mg PO days 15-21, and 10mg PO days 22-28.~Tacrolimus: 1-5 mg PO, twice a day (BID) days 2-180.~Mycophenolate mofetil: 500 mg PO, BID days 2-7, 500 mg PO each morning and 1000 mg each night, days 8-14, 1000 mg PO BID days 15-180."
120339|NCT01884571|O1|Outcome|Immunosuppression Regimen|"Participants were monitored for a three month lead-in period prior to beginning treatment. The Baseline Visit 1 occurred within 21 days after the Screening visit and 3 months prior to receiving the first does of the immunosuppressant regimen. Baseline Visits 2 and 3 occurred 2 and 1 month prior to the start of treatment.~All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months."
120340|NCT01884571|O1|Outcome|Immunosuppression Regimen|"Participants were monitored for a three month lead-in period prior to beginning treatment. The Baseline Visit 1 occurred within 21 days after the Screening visit and 3 months prior to receiving the first does of the immunosuppressant regimen. Baseline Visits 2 and 3 occurred 2 and 1 month prior to the start of treatment.~All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months."
120341|NCT01884571|O1|Outcome|Immunosuppression Regimen|"Participants were monitored for a three month lead-in period prior to beginning treatment. The Baseline Visit 1 occurred within 21 days after the Screening visit and 3 months prior to receiving the first does of the immunosuppressant regimen. Baseline Visits 2 and 3 occurred 2 and 1 month prior to the start of treatment.~All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months."
120342|NCT01884571|O1|Outcome|Immunosuppression Regimen|"Participants were monitored for a three month lead-in period prior to beginning treatment. The Baseline Visit 1 occurred within 21 days after the Screening visit and 3 months prior to receiving the first does of the immunosuppressant regimen. Baseline Visits 2 and 3 occurred 2 and 1 month prior to the start of treatment.~All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months."
120343|NCT01884571|O1|Outcome|Immunosuppression Regimen|"Participants were monitored for a three month lead-in period prior to beginning treatment. The Baseline Visit 1 occurred within 21 days after the Screening visit and 3 months prior to receiving the first does of the immunosuppressant regimen. Baseline Visits 2 and 3 occurred 2 and 1 month prior to the start of treatment.~All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months."
120344|NCT01884571|O1|Outcome|Immunosuppression Regimen|"Participants were monitored for a three month lead-in period prior to beginning treatment. The Baseline Visit 1 occurred within 21 days after the Screening visit and 3 months prior to receiving the first does of the immunosuppressant regimen. Baseline Visits 2 and 3 occurred 2 and 1 month prior to the start of treatment.~All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months."
120345|NCT01884571|O1|Outcome|Immunosuppression Regimen|"Participants were monitored for a three month lead-in period prior to beginning treatment. The Baseline Visit 1 occurred within 21 days after the Screening visit and 3 months prior to receiving the first does of the immunosuppressant regimen. Baseline Visits 2 and 3 occurred 2 and 1 month prior to the start of treatment.~All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months."
120346|NCT01884571|O1|Outcome|Immunosuppression Regimen|"Participants were monitored for a three month lead-in period prior to beginning treatment. The Baseline Visit 1 occurred within 21 days after the Screening visit and 3 months prior to receiving the first does of the immunosuppressant regimen. Baseline Visits 2 and 3 occurred 2 and 1 month prior to the start of treatment.~All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months."
120347|NCT01884571|E1|Reported Event|Immunosuppression Regimen|All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months.
120348|NCT01884545|B5|Baseline|Total|Total of all reporting groups
120349|NCT01884545|B4|Baseline|SRA+HC+GRC|"In addition to the standard risk assessment for CHD and T2D subjects will receive genetic risk counseling and health coaching intervention for 6 months.~Health coaching: Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).~Genetic risk counseling: In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.~Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject."
120382|NCT01884545|O3|Outcome|Genetic Risk Counseling|Patients who received genetic risk counseling
120383|NCT01884545|O2|Outcome|Non-Health Coaching|Participants who did not receive health coaching
120350|NCT01884545|B3|Baseline|SRA Plus Genetic Risk Counseling (GRC)|"In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.~Genetic risk counseling: In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.~Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject."
120351|NCT01884545|B2|Baseline|SRA Plus Health Coaching (HC)|"In addition to the standard risk assessment for CHD and T2D subjects will receive health coaching intervention for 6 months~Health coaching: Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).~Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject."
120352|NCT01884545|B1|Baseline|Standard Risk Assessment (SRA)|"Subjects will receive a standard risk assessment only for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.~Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject."
120353|NCT01884545|P4|Participant Flow|SRA+HC+GRC|"In addition to the standard risk assessment for CHD and T2D subjects will receive genetic risk counseling and health coaching intervention for 6 months.~Health coaching: Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).~Genetic risk counseling: In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.~Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject."
120354|NCT01884545|P3|Participant Flow|SRA Plus Genetic Risk Counseling (GRC)|"In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.~Genetic risk counseling: In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.~Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject."
120355|NCT01884545|P2|Participant Flow|SRA Plus Health Coaching (HC)|"In addition to the standard risk assessment for CHD and T2D subjects will receive health coaching intervention for 6 months~Health coaching: Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).~Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject."
120356|NCT01884545|P1|Participant Flow|Standard Risk Assessment (SRA)|"Subjects will receive a standard risk assessment only for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.~Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject."
120357|NCT01884545|O4|Outcome|Non-Genetic Risk Counseling|Patients who did not receive genetic risk counseling
120358|NCT01884545|O3|Outcome|Genetic Risk Counseling|Patients who received genetic risk counseling
120359|NCT01884545|O2|Outcome|Non-Health Coaching|Participants who did not receive health coaching
120360|NCT01884545|O1|Outcome|Health Coaching|Participants who received health coaching
120361|NCT01884545|O4|Outcome|Non-Genetic Risk Counseling|Patients who did not receive genetic risk counseling
120362|NCT01884545|O3|Outcome|Genetic Risk Counseling|Patients who received genetic risk counseling
120363|NCT01884545|O2|Outcome|Non-Health Coaching|Participants who did not receive health coaching
120364|NCT01884545|O1|Outcome|Health Coaching|Participants who received health coaching
120365|NCT01884545|O4|Outcome|Non-Genetic Risk Counseling|Patients who did not receive genetic risk counseling
120366|NCT01884545|O3|Outcome|Genetic Risk Counseling|Patients who received genetic risk counseling
120367|NCT01884545|O2|Outcome|Non-Health Coaching|Participants who did not receive health coaching
120368|NCT01884545|O1|Outcome|Health Coaching|Participants who received health coaching
120369|NCT01884545|O4|Outcome|Non-Genetic Risk Counseling|Patients who did not receive genetic risk counseling
120370|NCT01884545|O3|Outcome|Genetic Risk Counseling|Patients who received genetic risk counseling
120371|NCT01884545|O2|Outcome|Non-Health Coaching|Participants who did not receive health coaching
120372|NCT01884545|O1|Outcome|Health Coaching|Participants who received health coaching
120373|NCT01884545|O4|Outcome|Non-Genetic Risk Counseling|Patients who did not receive genetic risk counseling
120374|NCT01884545|O3|Outcome|Genetic Risk Counseling|Patients who received genetic risk counseling
120375|NCT01884545|O2|Outcome|Non-Health Coaching|Participants who did not receive health coaching
120376|NCT01884545|O1|Outcome|Health Coaching|Participants who received health coaching
120377|NCT01884545|O4|Outcome|Non-Genetic Risk Counseling|Patients who did not receive genetic risk counseling
120378|NCT01884545|O3|Outcome|Genetic Risk Counseling|Patients who received genetic risk counseling
120379|NCT01884545|O2|Outcome|Non-Health Coaching|Participants who did not receive health coaching
120380|NCT01884545|O1|Outcome|Health Coaching|Participants who received health coaching
120381|NCT01884545|O4|Outcome|Non-Genetic Risk Counseling|Patients who did not receive genetic risk counseling
120413|NCT01884545|O4|Outcome|Non-Genetic Risk Counseling|Patients who did not receive genetic risk counseling
120414|NCT01884545|O3|Outcome|Genetic Risk Counseling|Patients who received genetic risk counseling
120415|NCT01884545|O2|Outcome|Non-Health Coaching|Participants who did not receive health coaching
120416|NCT01884545|O1|Outcome|Health Coaching|Participants who received health coaching
120417|NCT01884545|O4|Outcome|Non-Genetic Risk Counseling|Patients who did not receive genetic risk counseling
120418|NCT01884545|O3|Outcome|Genetic Risk Counseling|Patients who received genetic risk counseling
120419|NCT01884545|O2|Outcome|Non-Health Coaching|Participants who did not receive health coaching
120420|NCT01884545|O1|Outcome|Health Coaching|Participants who received health coaching
120421|NCT01884545|O4|Outcome|Non-Genetic Risk Counseling|Patients who did not receive genetic risk counseling
120422|NCT01884545|O3|Outcome|Genetic Risk Counseling|Patients who received genetic risk counseling
120423|NCT01884545|O2|Outcome|Non-Health Coaching|Participants who did not receive health coaching
120424|NCT01884545|O1|Outcome|Health Coaching|Participants who received health coaching
120425|NCT01884545|O4|Outcome|Non-Genetic Risk Counseling|Patients who did not receive genetic risk counseling
120426|NCT01884545|O3|Outcome|Genetic Risk Counseling|Patients who received genetic risk counseling
120427|NCT01884545|O2|Outcome|Non-Health Coaching|Participants who did not receive health coaching
120428|NCT01884545|O1|Outcome|Health Coaching|Participants who received health coaching
120429|NCT01884545|O4|Outcome|Non-Genetic Risk Counseling|Patients who did not receive genetic risk counseling
120430|NCT01884545|O3|Outcome|Genetic Risk Counseling|Patients who received genetic risk counseling
120431|NCT01884545|O2|Outcome|Non-Health Coaching|Participants who did not receive health coaching
120432|NCT01884545|O1|Outcome|Health Coaching|Participants who received health coaching
120433|NCT01884545|O4|Outcome|Non-Genetic Risk Counseling|Patients who did not receive genetic risk counseling
120434|NCT01884545|O3|Outcome|Genetic Risk Counseling|Patients who received genetic risk counseling
120435|NCT01884545|O2|Outcome|Non-Health Coaching|Participants who did not receive health coaching
120436|NCT01884545|O1|Outcome|Health Coaching|Participants who received health coaching
120437|NCT01884545|O4|Outcome|Non-Genetic Risk Counseling|Patients who did not receive genetic risk counseling
120438|NCT01884545|O3|Outcome|Genetic Risk Counseling|Patients who received genetic risk counseling
120439|NCT01884545|O2|Outcome|Non-Health Coaching|Participants who did not receive health coaching
120440|NCT01884545|O1|Outcome|Health Coaching|Participants who received health coaching
120441|NCT01884545|O4|Outcome|Non-Genetic Risk Counseling|Patients who did not receive genetic risk counseling
120442|NCT01884545|O3|Outcome|Genetic Risk Counseling|Patients who received genetic risk counseling
120443|NCT01884545|O2|Outcome|Non-Health Coaching|Participants who did not receive health coaching
120444|NCT01884545|O1|Outcome|Health Coaching|Participants who received health coaching
120445|NCT01884545|O4|Outcome|Non-Genetic Risk Counseling|Patients who did not receive genetic risk counseling
120446|NCT01884545|O3|Outcome|Genetic Risk Counseling|Patients who received genetic risk counseling
120447|NCT01884545|O2|Outcome|Non-Health Coaching|Participants who did not receive health coaching
120448|NCT01884545|O1|Outcome|Health Coaching|Participants who received health coaching
120449|NCT01884545|O4|Outcome|Non-Genetic Risk Counseling|Patients who did not receive genetic risk counseling
120450|NCT01884545|O3|Outcome|Genetic Risk Counseling|Patients who received genetic risk counseling
120451|NCT01884545|O2|Outcome|Non-Health Coaching|Participants who did not receive health coaching
120452|NCT01884545|O1|Outcome|Health Coaching|Participants who received health coaching
120453|NCT01884545|O4|Outcome|Non-Genetic Risk Counseling|Patients who did not receive genetic risk counseling
120454|NCT01884545|O3|Outcome|Genetic Risk Counseling|Patients who received genetic risk counseling
120455|NCT01884545|O2|Outcome|Non-Health Coaching|Participants who did not receive health coaching
120456|NCT01884545|O1|Outcome|Health Coaching|Participants who received health coaching
120457|NCT01884545|E4|Reported Event|SRA+HC+GRC|"In addition to the standard risk assessment for CHD and T2D subjects will receive genetic risk counseling and health coaching intervention for 6 months.~Health coaching: Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).~Genetic risk counseling: In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.~Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject."
120458|NCT01884545|E3|Reported Event|SRA Plus Genetic Risk Counseling (GRC)|"In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.~Genetic risk counseling: In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.~Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject."
120459|NCT01884545|E2|Reported Event|SRA Plus Health Coaching (HC)|"In addition to the standard risk assessment for CHD and T2D subjects will receive health coaching intervention for 6 months~Health coaching: Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).~Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject."
120662|NCT01882647|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
120460|NCT01884545|E1|Reported Event|Standard Risk Assessment (SRA)|"Subjects will receive a standard risk assessment only for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.~Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject."
120461|NCT01884519|B3|Baseline|Total|Total of all reporting groups
120462|NCT01884519|B2|Baseline|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120463|NCT01884519|B1|Baseline|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120464|NCT01884519|P2|Participant Flow|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120465|NCT01884519|P1|Participant Flow|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120466|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120467|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120468|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120469|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120470|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120471|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120472|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120473|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120474|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120475|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120476|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120477|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120478|NCT01884519|O4|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120479|NCT01884519|O3|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccinationars Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120480|NCT01884519|O2|Outcome|Fluarix/Influsplit 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120481|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120482|NCT01884519|O4|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120483|NCT01884519|O3|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120484|NCT01884519|O2|Outcome|Fluarix/Influsplit 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120663|NCT01882647|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
120485|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120486|NCT01884519|O4|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120487|NCT01884519|O3|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120488|NCT01884519|O2|Outcome|Fluarix/Influsplit 18-60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120489|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120490|NCT01884519|O4|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120491|NCT01884519|O3|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120492|NCT01884519|O2|Outcome|Fluarix/Influsplit 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120493|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120494|NCT01884519|O2|Outcome|Fluarix/Influsplit &gt; 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120495|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120496|NCT01884519|O2|Outcome|Fluarix/Influsplit &gt; 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120497|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120498|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120499|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120500|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120501|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120502|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120503|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120504|NCT01884519|E2|Reported Event|Fluarix/Influsplit &gt; 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120505|NCT01884519|E1|Reported Event|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
120506|NCT01884064|B3|Baseline|Total|Total of all reporting groups
120507|NCT01884064|B2|Baseline|Sham rTMS|"Sham Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~Sham rTMS: Sham rTMS"
120508|NCT01884064|B1|Baseline|rTMS|"Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
120509|NCT01884064|P2|Participant Flow|Sham rTMS|"Sham or Placebo Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
120510|NCT01884064|P1|Participant Flow|rTMS|"Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
120511|NCT01884064|O2|Outcome|Sham rTMS|"Sham or Placebo Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
120512|NCT01884064|O1|Outcome|rTMS|"Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
120513|NCT01884064|E2|Reported Event|Sham rTMS|"Sham or Placebo Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
120514|NCT01884064|E1|Reported Event|rTMS|"Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
120515|NCT01883999|B1|Baseline|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
120516|NCT01883999|P1|Participant Flow|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
120517|NCT01883999|O1|Outcome|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
120518|NCT01883999|O1|Outcome|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
120519|NCT01883999|O1|Outcome|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
120520|NCT01883999|E1|Reported Event|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
120521|NCT01883986|B3|Baseline|Total|Total of all reporting groups
120522|NCT01883986|B2|Baseline|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
120523|NCT01883986|B1|Baseline|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.~Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
120524|NCT01883986|P2|Participant Flow|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
120525|NCT01883986|P1|Participant Flow|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.~Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
120526|NCT01883986|O2|Outcome|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
120527|NCT01883986|O1|Outcome|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.~Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
120528|NCT01883986|O2|Outcome|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
120529|NCT01883986|O1|Outcome|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.~Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
120530|NCT01883986|O2|Outcome|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
120531|NCT01883986|O1|Outcome|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.~Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
120532|NCT01883986|O2|Outcome|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
120533|NCT01883986|O1|Outcome|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.~Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
120534|NCT01883986|E2|Reported Event|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
120664|NCT01882647|E2|Reported Event|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
120665|NCT01882647|E1|Reported Event|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
120535|NCT01883986|E1|Reported Event|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.~Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
120536|NCT01883908|B3|Baseline|Total|Total of all reporting groups
120537|NCT01883908|B2|Baseline|Usual Medical Care|"Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
120538|NCT01883908|B1|Baseline|Acupuncture With Seirin® Needles|"Participants will be randomized to receive acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Acupuncture with Seirin® needles: Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
120539|NCT01883908|P2|Participant Flow|Usual Medical Care|"Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
120540|NCT01883908|P1|Participant Flow|Acupuncture With Seirin® Needles|"Participants will be randomized to receive acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Acupuncture with Seirin® needles: Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
120541|NCT01883908|O2|Outcome|Usual Medical Care|"Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
120542|NCT01883908|O1|Outcome|Acupuncture With Seirin® Needles|"Participants will be randomized to receive acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Acupuncture with Seirin® needles: Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
120543|NCT01883908|O2|Outcome|Usual Medical Care|"Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
120544|NCT01883908|O1|Outcome|Acupuncture With Seirin® Needles|"Participants will be randomized to receive acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Acupuncture with Seirin® needles: Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
120545|NCT01883908|E2|Reported Event|Usual Medical Care|"Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
120546|NCT01883908|E1|Reported Event|Acupuncture With Seirin® Needles|"Participants will be randomized to receive acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Acupuncture with Seirin® needles: Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
120547|NCT01883895|B1|Baseline|Exercise Treatment|"Concentric exercise will utilize a dumbbell with elbow flexion exercise. Isometric exercise will consist of submaximal exercise by squeezing the hand dynamometer with dominant hand at 30% of maximum for same duration as for concentric contractions,.~Forgioni-Barber pressure-pain stimulator: Pain testing will be conducted using a Forgioni-Barber pressure-pain stimulator to deliver 3000-gm force to the middle digit of the non-dominant middle finger for up to 120 seconds. During stimulation, subjects will press a button attached to a timer when the pressure stimulus first becomes painful (pain threshold) and will also rate their perceived pain intensity using a 0-100 numeric pain rating scale at 20 second intervals during the 2 minute exposure to the pressure stimulus. This validated protocol has been used in previous research by investigators in this study."
120666|NCT01882543|B3|Baseline|Total|Total of all reporting groups
120667|NCT01882543|B2|Baseline|Placebo|"1 x placebo capsule daily~Placebo: Double blind placebo capsule"
120548|NCT01883895|P1|Participant Flow|Exercise Treatment|"Concentric exercise will utilize a dumbbell with elbow flexion exercise. Isometric exercise will consist of submaximal exercise by squeezing the hand dynamometer with dominant hand at 30% of maximum for same duration as for concentric contractions,.~Forgioni-Barber pressure-pain stimulator: Pain testing will be conducted using a Forgioni-Barber pressure-pain stimulator to deliver 3000-gm force to the middle digit of the non-dominant middle finger for up to 120 seconds. During stimulation, subjects will press a button attached to a timer when the pressure stimulus first becomes painful (pain threshold) and will also rate their perceived pain intensity using a 0-100 numeric pain rating scale at 20 second intervals during the 2 minute exposure to the pressure stimulus. This validated protocol has been used in previous research by investigators in this study."
120549|NCT01883895|O1|Outcome|Exercise Treatment|"Concentric exercise: subject will utilize a dumbbell with elbow flexion exercise.~Isometric exercise: Subjects will perform 5 sets of sustained muscle contraction.~Control: Subjects will undergo a control arm where they will rest for approximately 10 minutes.~Pain testing conducted Forgionei-Barber pressure pain stimulator"
120550|NCT01883895|O1|Outcome|Exercise Treatment|"Concentric exercise: subject will utilize a dumbbell with elbow flexion exercise.~Isometric exercise: Subjects will perform 5 sets of sustained muscle contraction.~Control: Subjects will undergo a control arm where they will rest for approximately 10 minutes.~Pain testing conducted Forgionei-Barber pressure pain stimulator"
120551|NCT01883895|E1|Reported Event|Exercise Treatment|"Concentric exercise: subject will utilize a dumbbell with elbow flexion exercise.~Isometric exercise: Subjects will perform 5 sets of sustained muscle contraction.~Control: Subjects will undergo a control arm where they will rest for approximately 10 minutes.~Pain testing conducted Forgionei-Barber pressure pain stimulator"
120552|NCT01883804|B1|Baseline|Study Group|"All participants selected to continue with Methyldopa administration.~Methyldopa: 6 weeks of Methyldopa administration; where the dose will be increased according to safety of efficacy."
120553|NCT01883804|P1|Participant Flow|Methyldopa Group|"All participants selected to continue with Methyldopa administration.~Methyldopa: 6 weeks of Methyldopa administration; where the dose will be increased according to safety of efficacy."
120554|NCT01883804|O1|Outcome|Study Group|open label treatment; dose escalation of methyldopa
120555|NCT01883804|O1|Outcome|Study Group|open label treatment; dose escalation of methyldopa
120556|NCT01883804|O1|Outcome|Study Group|open label treatment; dose escalation of methyldopa
120557|NCT01883804|O1|Outcome|Study Group|open label treatment; dose escalation of methyldopa
120558|NCT01883804|E1|Reported Event|Study Group|"All participants selected to continue with Methyldopa administration.~Methyldopa: 6 weeks of Methyldopa administration; where the dose will be increased according to safety of efficacy."
120559|NCT01883635|B3|Baseline|Total|Total of all reporting groups
120560|NCT01883635|B2|Baseline|Dyadic Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
120561|NCT01883635|B1|Baseline|Individual Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
120562|NCT01883635|P2|Participant Flow|Dyadic Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
120563|NCT01883635|P1|Participant Flow|Individual Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
120564|NCT01883635|O2|Outcome|Dyadic Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
120565|NCT01883635|O1|Outcome|Individual Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
120566|NCT01883635|O2|Outcome|Dyadic Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
120567|NCT01883635|O1|Outcome|Individual Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
120568|NCT01883635|O2|Outcome|Dyadic Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
120569|NCT01883635|O1|Outcome|Individual Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
120570|NCT01883635|E4|Reported Event|Dyadic Exercise Intervention - Caregivers|Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)
120571|NCT01883635|E3|Reported Event|Individual Exercise Intervention - Caregivers|Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)
120572|NCT01883635|E2|Reported Event|Dyadic Exercise Intervention - Cancer Survivors|Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)
120573|NCT01883635|E1|Reported Event|Individual Exercise Intervention - Cancer Survivors|Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)
120574|NCT01883453|B3|Baseline|Total|Total of all reporting groups
120575|NCT01883453|B2|Baseline|Nasal Spray With Glucose Oxidase+Glucose|"A nasal spray with 200U/ml of glucose oxidase + 5% glucose. Treatment starts with 5 puffs in each nostril at the first day, and thereafter trhee times daily for a total treatment time of one week.~Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme"
120576|NCT01883453|B1|Baseline|Saline+Glucose Nasal Spray|"A nasal spray with isotone saline + 5% glucose, dosing one puff 5 times daily in each nostril at the first treatment day and thereafter trice daily for a total of one week~Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device"
120577|NCT01883453|P2|Participant Flow|Nasal Spray With Glucose Oxidase+Glucose|"A nasal spray with 200U/ml of glucose oxidase + 5% glucose. Treatment starts with 5 puffs in each nostril at the first day, and thereafter trhee times daily for a total treatment time of one week.~Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme"
120578|NCT01883453|P1|Participant Flow|Saline+Glucose Nasal Spray|"A nasal spray with isotone saline + 5% glucose, dosing one puff 5 times daily in each nostril at the first treatment day and thereafter trice daily for a total of one week~Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device"
120579|NCT01883453|O2|Outcome|Nasal Spray With Glucose Oxidase+Glucose|"A nasal spray with 200U/ml of glucose oxidase + 5% glucose. Treatment starts with 5 puffs in each nostril at the first day, and thereafter trhee times daily for a total treatment time of one week.~Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme"
120580|NCT01883453|O1|Outcome|Saline+Glucose Nasal Spray|"A nasal spray with isotone saline + 5% glucose, dosing one puff 5 times daily in each nostril at the first treatment day and thereafter trice daily for a total of one week~Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device"
120581|NCT01883453|E2|Reported Event|Nasal Spray With Glucose Oxidase+Glucose|"A nasal spray with 200U/ml of glucose oxidase + 5% glucose. Treatment starts with 5 puffs in each nostril at the first day, and thereafter trhee times daily for a total treatment time of one week.~Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme"
120582|NCT01883453|E1|Reported Event|Saline+Glucose Nasal Spray|"A nasal spray with isotone saline + 5% glucose, dosing one puff 5 times daily in each nostril at the first treatment day and thereafter trice daily for a total of one week~Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device"
120583|NCT01883440|B3|Baseline|Total|Total of all reporting groups
120584|NCT01883440|B2|Baseline|Glucose Oxidase + Glucose|"A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.~Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device"
120585|NCT01883440|B1|Baseline|Saline+Glucose|"A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week~saline+glucose: Isotone saline+5%glucose in a bag-on-valve nasal spray device"
120586|NCT01883440|P2|Participant Flow|Glucose Oxidase + Glucose|"A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.~Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device"
120587|NCT01883440|P1|Participant Flow|Saline+Glucose|"A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week~saline+glucose: Isotone saline+5%glucose in a bag-on-valve nasal spray device"
120588|NCT01883440|O2|Outcome|Glucose Oxidase + Glucose|"A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.~Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device"
120589|NCT01883440|O1|Outcome|Saline+Glucose|A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week
120590|NCT01883440|O2|Outcome|Glucose Oxidase + Glucose|"A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.~Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device"
120591|NCT01883440|O1|Outcome|Saline+Glucose|"A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week~saline+glucose: Isotone saline+5%glucose in a bag-on-valve nasal spray device"
120592|NCT01883440|E2|Reported Event|Glucose Oxidase + Glucose|"A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.~Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device"
120593|NCT01883440|E1|Reported Event|Saline+Glucose|"A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week~saline+glucose: Isotone saline+5%glucose in a bag-on-valve nasal spray device"
120594|NCT01883427|B3|Baseline|Total|Total of all reporting groups
120595|NCT01883427|B2|Baseline|Nasal Spray With Glucose Oxidase+Glucose|"Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months.~Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx"
120596|NCT01883427|B1|Baseline|Saline+Glucose Nasal Spray|"Nasal spray with saline+glucose twice daily for 3 months~Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose"
120597|NCT01883427|P2|Participant Flow|Nasal Spray With Glucose Oxidase+Glucose|"Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months.~Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx"
120598|NCT01883427|P1|Participant Flow|Saline+Glucose Nasal Spray|"Nasal spray with saline+glucose twice daily for 3 months~Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose"
136519|NCT01806857|O1|Outcome|Active Drug (Neudexta)|
120599|NCT01883427|O2|Outcome|Nasal Spray With Glucose Oxidase+Glucose|"Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months.~Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx"
120600|NCT01883427|O1|Outcome|Saline+Glucose Nasal Spray|"Nasal spray with saline+glucose twice daily for 3 months~Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose"
120601|NCT01883427|E2|Reported Event|Nasal Spray With Glucose Oxidase+Glucose|"Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months.~Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx"
120602|NCT01883427|E1|Reported Event|Saline+Glucose Nasal Spray|"Nasal spray with saline+glucose twice daily for 3 months~Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose"
120603|NCT01882907|B3|Baseline|Total|Total of all reporting groups
120604|NCT01882907|B2|Baseline|Pioglitazone|"Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~Pioglitazone: Pioglitazone 15mg bid for 16 weeks"
120605|NCT01882907|B1|Baseline|Vildagliptin|"vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~vildagliptin: vildagliptin 50mg bid for 16 weeks"
120606|NCT01882907|P2|Participant Flow|Pioglitazone|"Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~Pioglitazone: Pioglitazone 15mg bid for 16 weeks"
120607|NCT01882907|P1|Participant Flow|Vildagliptin|"vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~vildagliptin: vildagliptin 50mg bid for 16 weeks"
120608|NCT01882907|O2|Outcome|Pioglitazone|"Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~Pioglitazone: Pioglitazone 15mg bid for 16 weeks"
120609|NCT01882907|O1|Outcome|Vildagliptin|"vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~vildagliptin: vildagliptin 50mg bid for 16 weeks"
120610|NCT01882907|E2|Reported Event|Pioglitazone|"Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~Pioglitazone: Pioglitazone 15mg bid for 16 weeks"
120611|NCT01882907|E1|Reported Event|Vildagliptin|"vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~vildagliptin: vildagliptin 50mg bid for 16 weeks"
120612|NCT01882868|B1|Baseline|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120613|NCT01882868|P1|Participant Flow|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg intravenous (IV) infusion (1-2 hours) on Day 1 of Cycle 1 and every 2 weeks (q2w) thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until disease progression (DP), unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120614|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120615|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120616|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120617|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120618|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120619|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120668|NCT01882543|B1|Baseline|AQX-1125|"1 x AQX-1125 Capsule daily~AQX-1125: Synthetic SHIP1 activator"
120620|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120621|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120622|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120623|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120624|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120625|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120626|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120627|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120628|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120629|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120630|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120631|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120632|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120633|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120669|NCT01882543|P2|Participant Flow|Placebo|"1 x placebo capsule daily~Placebo: Double blind placebo capsule"
120670|NCT01882543|P1|Participant Flow|AQX-1125|"1 x AQX-1125 Capsule daily~AQX-1125: Synthetic SHIP1 activator"
120671|NCT01882543|O1|Outcome|AQX-1125|AQX-1125 Plasma and Urine Concentrations at Week 4 and 6
120634|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120635|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120636|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120637|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120638|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120639|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120640|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120641|NCT01882868|E1|Reported Event|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
120642|NCT01882725|B1|Baseline|Erchonia HP Scanner (HPS)|"The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
120643|NCT01882725|P1|Participant Flow|Erchonia HP Scanner (HPS)|"The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
120644|NCT01882725|O1|Outcome|Erchonia HP Scanner (HPS)|"The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
120645|NCT01882725|O1|Outcome|Erchonia HP Scanner (HPS)|"The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
120646|NCT01882725|E1|Reported Event|Erchonia HP Scanner (HPS)|"The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
120647|NCT01882647|B3|Baseline|Total|Total of all reporting groups
120648|NCT01882647|B2|Baseline|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
120649|NCT01882647|B1|Baseline|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
120650|NCT01882647|P2|Participant Flow|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
120651|NCT01882647|P1|Participant Flow|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
120652|NCT01882647|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
120653|NCT01882647|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
120654|NCT01882647|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
120655|NCT01882647|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
120672|NCT01882543|O2|Outcome|Placebo|"1 x placebo capsule daily~Placebo: Double blind placebo capsule"
120673|NCT01882543|O1|Outcome|AQX-1125|"1 x AQX-1125 Capsule daily~AQX-1125: Synthetic SHIP1 activator"
120674|NCT01882543|O2|Outcome|Placebo|"1 x placebo capsule daily~Placebo: Double blind placebo capsule"
120675|NCT01882543|O1|Outcome|AQX-1125|"1 x AQX-1125 Capsule daily~AQX-1125: Synthetic SHIP1 activator"
120676|NCT01882543|O2|Outcome|Placebo|"1 x placebo capsule daily~Placebo: Double blind placebo capsule"
120677|NCT01882543|O1|Outcome|AQX-1125|"1 x AQX-1125 Capsule daily~AQX-1125: Synthetic SHIP1 activator"
120678|NCT01882543|O2|Outcome|Placebo|"1 x placebo capsule daily~Placebo: Double blind placebo capsule"
120679|NCT01882543|O1|Outcome|AQX-1125|"1 x AQX-1125 Capsule daily~AQX-1125: Synthetic SHIP1 activator"
120680|NCT01882543|O2|Outcome|Placebo|"1 x placebo capsule daily~Placebo: Double blind placebo capsule"
120681|NCT01882543|O1|Outcome|AQX-1125|"1 x AQX-1125 Capsule daily~AQX-1125: Synthetic SHIP1 activator"
120682|NCT01882543|O2|Outcome|Placebo|"1 x placebo capsule daily~Placebo: Double blind placebo capsule"
120683|NCT01882543|O1|Outcome|AQX-1125|"1 x AQX-1125 Capsule daily~AQX-1125: Synthetic SHIP1 activator"
120684|NCT01882543|O2|Outcome|Placebo|"1 x placebo capsule daily~Placebo: Double blind placebo capsule"
120685|NCT01882543|O1|Outcome|AQX-1125|"1 x AQX-1125 Capsule daily~AQX-1125: Synthetic SHIP1 activator"
120686|NCT01882543|O2|Outcome|Placebo|"1 x placebo capsule daily~Placebo: Double blind placebo capsule"
120687|NCT01882543|O1|Outcome|AQX-1125|"1 x AQX-1125 Capsule daily~AQX-1125: Synthetic SHIP1 activator"
120688|NCT01882543|E2|Reported Event|Placebo|"1 x placebo capsule daily~Placebo: Double blind placebo capsule"
120689|NCT01882543|E1|Reported Event|AQX-1125|"1 x AQX-1125 Capsule daily~AQX-1125: Synthetic SHIP1 activator"
120690|NCT01882465|B1|Baseline|Overall|All subjects that were enrolled into the study.
120691|NCT01882465|P7|Participant Flow|Not Assigned|Subjects that signed the inform consent, but them withdrew consent, prior to lens dispensing.
120692|NCT01882465|P6|Participant Flow|Hefilcon A/Etafilcon A /2-HEMA, EGDMA Non-ionic|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the hefilcon A lens first, the etafilcon A lens second and the 2-HEMA, EGDMA Non-ionic material lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
120693|NCT01882465|P5|Participant Flow|Hefilcon A/2-HEMA, EGDMA Non-ionic/Etafilcon A|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the hefilcon A lens first, the 2-HEMA, EGDMA Non-ionic material lens second and the etafilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
120694|NCT01882465|P4|Participant Flow|2-HEMA, EGDMA Non-ionic/Hefilcon A/Etafilcon A|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the 2-HEMA, EGDMA Non-ionic material lens first, the hefilcon A lens second and the etafilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
120695|NCT01882465|P3|Participant Flow|2-HEMA, EGDMA Non-ionic/Etafilcon A/Hefilcon A|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the 2-HEMA, EGDMA Non-ionic material lens first, the etafilcon A lens second and the hefilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
120696|NCT01882465|P2|Participant Flow|Etafilcon A/Hefilcon A/2-HEMA, EGDMA Non-ionic|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the etafilcon A lens first, the hefilcon A lens second and the 2-HEMA, EGDMA Non-ionic material lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
120697|NCT01882465|P1|Participant Flow|Etafilcon A/2-HEMA, EGDMA/Hefilcon A|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the etafilcon A lens first, the 2-HEMA, EGDMA Non-ionic material lens second and the hefilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
120698|NCT01882465|O3|Outcome|Hefilcon A|Subjects that received the hefilcon A lens in any of the three study periods.
120699|NCT01882465|O2|Outcome|2-HEMA, EGDMA Non-ionic|Subjects that received the 2-HEMA, EGDMA Non-ionic lens in any of the three study periods.
120700|NCT01882465|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in any of the three study periods.
120701|NCT01882465|E3|Reported Event|Hefilcon A|Subjects that received the hefilcon A lens in any of the three study periods.
120702|NCT01882465|E2|Reported Event|2-HEMA, EGDMA Non-ionic|Subjects that received the 2-HEMA, EGDMA Non-ionic lens in any of the three study periods.
120703|NCT01882465|E1|Reported Event|Etafilcon A|Subjects that received the etafilcon A lens in any of the three study periods.
120704|NCT01882439|B5|Baseline|Total|Total of all reporting groups
120705|NCT01882439|B4|Baseline|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets, twice daily, up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets, twice daily.
120706|NCT01882439|B3|Baseline|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets, twice daily, up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet, twice daily, and one placebo tablet, twice daily.
120707|NCT01882439|B2|Baseline|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets, twice daily.
120708|NCT01882439|B1|Baseline|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet, twice daily, and one placebo tablet twice daily.
120709|NCT01882439|P4|Participant Flow|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets, twice daily, up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets, twice daily.
120710|NCT01882439|P3|Participant Flow|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets, twice daily, up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet, twice daily, and one placebo tablet, twice daily.
120711|NCT01882439|P2|Participant Flow|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets, twice daily.
121055|NCT01881113|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
120712|NCT01882439|P1|Participant Flow|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet, twice daily, and one placebo tablet twice daily.
120713|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120714|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120715|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120716|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120717|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120718|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120719|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120720|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120721|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120722|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120723|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120724|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120725|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120726|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120727|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120728|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120729|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120730|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120731|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120732|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120733|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120734|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120735|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120736|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120737|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120738|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120739|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120740|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120741|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120742|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120743|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120744|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120745|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120746|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120747|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120748|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120749|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120789|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120750|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120751|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120752|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120753|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120754|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120755|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120756|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120757|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120758|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120759|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120760|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120761|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120762|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120763|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120764|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120765|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120766|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120767|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120768|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120769|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120770|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120771|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120772|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120773|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120774|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120775|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120776|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120777|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120778|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120779|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120780|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120781|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120782|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120783|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120784|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120785|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120786|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120787|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120788|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
136520|NCT01806857|O2|Outcome|Matching Placebo|
120790|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120791|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120792|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120793|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120794|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120795|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120796|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120797|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120798|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120799|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120800|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120801|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120802|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120803|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120804|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120805|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120806|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120807|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120808|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120809|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120810|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120811|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120812|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120813|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120814|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120815|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120816|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120817|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120818|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120819|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120820|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120821|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120822|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120823|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120824|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120825|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120826|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120827|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120828|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120829|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120830|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120831|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120832|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120833|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120834|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120835|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120836|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120837|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120838|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120839|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120840|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120841|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120842|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120843|NCT01882439|O3|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120844|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120845|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120846|NCT01882439|O3|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120847|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120848|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120849|NCT01882439|O3|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120850|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120851|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120852|NCT01882439|O3|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120853|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120854|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120855|NCT01882439|O3|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120856|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120857|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120858|NCT01882439|O3|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120859|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120860|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120861|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120862|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablet twice daily.
120863|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120864|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120865|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120866|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120867|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120868|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120869|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120870|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120871|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120872|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120873|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily for 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120874|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120875|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120876|NCT01882439|O5|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120877|NCT01882439|O4|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablet twice daily.
120878|NCT01882439|O3|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120879|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120880|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120881|NCT01882439|O3|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120882|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120883|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120884|NCT01882439|O3|Outcome|Placebo|Participants received two placebo tablets twice daily up to 3 months.
120885|NCT01882439|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120886|NCT01882439|O1|Outcome|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120887|NCT01882439|E4|Reported Event|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.
120888|NCT01882439|E3|Reported Event|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120889|NCT01882439|E2|Reported Event|Tofacitinib, 10 mg, Twice Daily|Participants received two 5 mg tofacitinib tablets twice daily.
120890|NCT01882439|E1|Reported Event|Tofacitinib, 5 mg Twice Daily|Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.
120891|NCT01882413|B1|Baseline|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
120892|NCT01882413|P1|Participant Flow|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
120893|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
120894|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
120895|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
120896|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
120897|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
120898|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
120899|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
120900|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
120901|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
120902|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
120903|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
120904|NCT01882413|E1|Reported Event|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
120905|NCT01882257|B4|Baseline|Total|Total of all reporting groups
120906|NCT01882257|B3|Baseline|BiPAP (AVAPS) for Nocturnal Hypoventilation|"Patients whose home-based sleep study detects nocturnal hypoventilation in the presence or absence of obstructive sleep apnea. Noninvasive ventilatory support will be prescribed according to standard clinical criteria. BiPAP/AVAPS (Phillips Respironics) is worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation.~BiPAP/AVAPS (Phillips Respironics): BiPAP/AVAPS (Phillips Respironics) is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation due to an underlying neuromuscular disorder."
120907|NCT01882257|B2|Baseline|BiPAP -Auto for Sleep Apnea|"Patients whose home-based sleep study detects obstructive sleep apnea, but no nocturnal hypoventilation. Noninvasive ventilatory support will be prescribed according to standard clinical criteria.~BiPAP: BiPAP-auto (Phillips Respironics)is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is used to treat obstructive sleep apnea."
120908|NCT01882257|B1|Baseline|Normal Sleep Breathing|Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention.
120909|NCT01882257|P3|Participant Flow|BiPAP (AVAPS) for Nocturnal Hypoventilation|"Patients whose home-based sleep study detects nocturnal hypoventilation in the presence or absence of obstructive sleep apnea. Noninvasive ventilatory support will be prescribed according to standard clinical criteria. BiPAP/AVAPS (Phillips Respironics) is worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation.~BiPAP/AVAPS (Phillips Respironics): BiPAP/AVAPS (Phillips Respironics) is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation due to an underlying neuromuscular disorder."
120910|NCT01882257|P2|Participant Flow|BiPAP -Auto for Sleep Apnea|"Patients whose home-based sleep study detects obstructive sleep apnea, but no nocturnal hypoventilation. Noninvasive ventilatory support will be prescribed according to standard clinical criteria.~BiPAP: BiPAP-auto (Phillips Respironics)is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is used to treat obstructive sleep apnea."
120911|NCT01882257|P1|Participant Flow|Normal Sleep Breathing|Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention.
120912|NCT01882257|O1|Outcome|Entire Tested Population|All groups are considered together because in determining the efficiency and reliability of home-based overnight testing, there is no difference between the three groups
120913|NCT01882257|O1|Outcome|Entire Tested Population|All groups are considered together because this outcome is simply identifying what portion of the defined population (People with Spinal Cord Injury) have which types of sleep disordered breathing
120914|NCT01882257|E3|Reported Event|BiPAP (AVAPS) for Nocturnal Hypoventilation|"Patients whose home-based sleep study detects nocturnal hypoventilation in the presence or absence of obstructive sleep apnea. Noninvasive ventilatory support will be prescribed according to standard clinical criteria. BiPAP/AVAPS (Phillips Respironics) is worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation.~BiPAP/AVAPS (Phillips Respironics): BiPAP/AVAPS (Phillips Respironics) is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation due to an underlying neuromuscular disorder."
120915|NCT01882257|E2|Reported Event|BiPAP -Auto for Sleep Apnea|"Patients whose home-based sleep study detects obstructive sleep apnea, but no nocturnal hypoventilation. Noninvasive ventilatory support will be prescribed according to standard clinical criteria.~BiPAP: BiPAP-auto (Phillips Respironics)is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is used to treat obstructive sleep apnea."
120916|NCT01882257|E1|Reported Event|Normal Sleep Breathing|Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention.
120917|NCT01882062|B1|Baseline|Triheptanoin Oil at 1g/kg/Day for 1 Month|Patients received triheptanoin oil at 1g/kg/day for 1 month
120918|NCT01882062|P1|Participant Flow|Triheptanoin Oil at 1g/kg/Day for 1 Month|Patients received triheptanoin oil at 1g/kg/day for 1 month
120919|NCT01882062|O1|Outcome|Triheptanoin Oil at 1g/kg/Day for 1 Month|All the participants received triheptanoin oil at 1g/kg/day for 1 month
120920|NCT01882062|E1|Reported Event|Triheptanoin Oil at 1g/kg/Day for 1 Month|All the participants received triheptanoin oil at 1g/kg/day for 1 month
120921|NCT01881984|B1|Baseline|Ravicti|"Open Label Study~Ravicti: Open-label design comparing Ravicti at doses of 2, 4, and 6 grams/m2/day"
120922|NCT01881984|P1|Participant Flow|Ravicti|"Open Label Study~Ravicti: Open-label design comparing Ravicti at doses of 2, 4, and 6 grams/m2/day"
120923|NCT01881984|O1|Outcome|Ravicti|"Open Label Study~Ravicti: Open-label design comparing Ravicti at doses of 2, 4, and 6 grams/m2/day"
120924|NCT01881984|O1|Outcome|Ravicti|"Open Label Study~Ravicti: Open-label design comparing Ravicti at doses of 2, 4, and 6 grams/m2/day"
120925|NCT01881984|E1|Reported Event|Ravicti|"Open Label Study~Ravicti: Open-label design comparing Ravicti at doses of 2, 4, and 6 grams/m2/day"
120926|NCT01881932|B4|Baseline|Total|Total of all reporting groups
120927|NCT01881932|B3|Baseline|Sham Acupuncture|"Patients stratified based on cancer (breast cancer vs colorectal cancer). The patients will be randomly assigned to get sham acupuncture until the end of their chemo while following the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemo received in the past week. Record how much chemo received all together. Each week patient will have blood drawn (about 1 tsp) to check nerve growth factors levels.~Sham Acupuncture using Park Sham placebo acupuncture device: Participants will get sham acupuncture until the end of chemo.~Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device consisting of a retractable needle and an adhesive tube into the sham points, and then immediately apply 2 pieces of adhesive tape next to the needles. She will tap a mock plastic needle gui"
120928|NCT01881932|B2|Baseline|Acupuncture|Pts stratified based on cancer (breast cancer vs colorectal cancer). Patients randomly assigned to get acupuncture until the end of their chemo. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemo received in past week. Record how much chemo received all together. Each week patient will have blood drawn (about 1 tsp) to check nerve growth factors levels. All patients will follow the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication allowed. In standard care arm, patients will not get addiinl therapy for CIPN. Acupuncture using Seirin® needles: Participants will get acupuncture weekly til the end of chemo. Subjects will receive acupuncture at documented acupoints. To improve blinding effect, the acupuncturist will also tap 2 guiding tubes at 2 sham points & immediately affix a pair of needles to the surface of the same points with adhesive tape, w
121056|NCT01881113|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121057|NCT01881113|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
120929|NCT01881932|B1|Baseline|Standard Care|Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). In standard care arm, patients will not receive additional therapy for CIPN. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed.
120930|NCT01881932|P3|Participant Flow|Sham Acupuncture|"Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). The patients will be randomly assigned to receive sham acupuncture until the end of their chemotherapy while following the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication allowed. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels.~Sham Acupuncture using Park Sham placebo acupuncture device: Participants will receive sham acupuncture until the end of chemotherapy.~Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device consisting of a retractable needle and an adhesive tube into the sham points, and then immediately apply 2 pieces of adhesive tape"
120931|NCT01881932|P2|Participant Flow|Acupuncture|"Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). Patients will be randomly assigned to receive acupuncture until the end of their chemotherapy. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. In standard care arm, patients will not receive additional therapy for CIPN.~Acupuncture using Seirin® needles: Participants will receive acupuncture weekly until the end of chemotherapy.~Subjects will receive acupuncture at documented acupoints. To improve blinding effect, the acupuncturist will also tap 2 guiding tubes at 2 sham points, and"
120932|NCT01881932|P1|Participant Flow|Standard Care|Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). In standard care arm, patients will not receive additional therapy for CIPN. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed.
120933|NCT01881932|O3|Outcome|Sham Acupuncture|Patients stratified based on cancer (breast vs colorectal). Patients to get sham acupuncture til the end of their chemo & following the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication allowed. Pt complete a wkly questionnaire to determine severity of nerve pain symptoms. Each wk record the total amount of chemo in the past week & all together. Each wk patient have blood drawn (about 1 tsp) to check nerve growth factors levels. Sham Acupuncture using Park Sham placebo acupuncture device: Particip will get sham acupuncture til the end of chemo. Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device of a retractable needle & an adhesive tube into sham points &apply 2 pieces of adhesive tape next to needles; will tap a mock plastic needle guiding tube on surface of each of 8 true points in the arm & leg to produce some discernible sensation & then apply needle w/ piece of adhesive tape to dermal surface, w/out needle insertion.
120934|NCT01881932|O2|Outcome|Acupuncture|Patients stratified based on cancer (breast cancer vs colorectal cancer). The patients will be randomly assigned to get acupuncture until the end of their chemo. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemo received in the past week & all together. Each week patient will have blood drawn (about 1 tsp) to check nerve growth factors levels. All patients will follow the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication allowed. In standard care arm, patients will not get additional therapy for CIPN. Acupuncture using Seirin® needles: Participants will get acupuncture weekly until the end of chemotherapy. Subjects will get acupuncture at documented acupoints. To improve blinding effect, acupuncturist will also tap 2 guiding tubes at 2 sham points & immediately affix a pair of needles to surface of the same points with adhesive tape, no needle insertion.
120935|NCT01881932|O1|Outcome|Standard Care|Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). In standard care arm, patients will not receive additional therapy for CIPN. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed.
120936|NCT01881932|E3|Reported Event|Sham Acupuncture|Patients stratified based on cancer (breast vs colorectal). The patients get sham acupuncture til the end of chemo with same chemo dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. Patient complete a weekly questionnaire to determine severity of nerve pain symptoms. Weekly record total amount of chemo received in the past week & all together. Each week patient have blood drawn (about 1 tsp) to check nerve growth factors levels. Sham Acupuncture using Park Sham placebo acupuncture device: Particip will get sham acupuncture til the end of chemo. Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device consisting of a retractable needle & adhesive tube into the sham points, & then apply 2 pieces of adhesive tape next to needles. Will tap mock plastic needle guiding tube on the surface of each of 8 true points in arm & leg to produce sensation & apply a needle with piece of adhesive tape to dermal surface, no needle insertion.
120980|NCT01881230|B3|Baseline|Arm C: Gemcitabine + Carboplatin|Participants received gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration, followed by carboplatin AUC 2 on Days 1 and 8 by IV administration in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
120937|NCT01881932|E2|Reported Event|Acupuncture|"Patients stratified based on cancer (breast vs colorectal). Patients randomly assigned to get acupuncture until the end of their chemo. Patient will complete a weekly questionnaire to determine severity of nerve pain symptoms. Each week record the total amount of chemo received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 tsp) to check nerve growth factors levels. All patients will follow the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. In standard care arm, patients will not get additional therapy for CIPN.~Acupuncture using Seirin® needles: Participants will receive acupuncture weekly until the end of chemotherapy.~Subjects will get acupuncture at documented acupoints. To improve blinding effect, the acupuncturist will tap 2 guiding tubes at 2 sham points & affix a pair of needles to the surface of the same points with adhesive tape, without needle insertion."
120938|NCT01881932|E1|Reported Event|Standard Care|Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). In standard care arm, patients will not receive additional therapy for CIPN. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed.
120939|NCT01881776|B4|Baseline|Total|Total of all reporting groups
120940|NCT01881776|B3|Baseline|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
120941|NCT01881776|B2|Baseline|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
120942|NCT01881776|B1|Baseline|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
120943|NCT01881776|P3|Participant Flow|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
120944|NCT01881776|P2|Participant Flow|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
120945|NCT01881776|P1|Participant Flow|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
120946|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
120947|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
120948|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
120949|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
120950|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
120951|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
120952|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
120953|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
120954|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
120955|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
120956|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
120957|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
120958|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
120959|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
120960|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
120961|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
120962|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
120963|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
120964|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
121048|NCT01881113|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
120965|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
120966|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
120967|NCT01881776|E3|Reported Event|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
120968|NCT01881776|E2|Reported Event|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
120969|NCT01881776|E1|Reported Event|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
120970|NCT01881737|B1|Baseline|Pregnenolone|"Twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.~Week 1 and 2: 100 mg Week 3 and 4: 200 mg Week 5 and 6: 300 mg Week 7 and 8: 400 mg Week 9 -12: 500 mg At the end of Week 12, pregnenolone was decreased by 50 mg twice a day every 3 days until it was discontinued.~If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs."
120971|NCT01881737|P1|Participant Flow|Pregnenolone|Open-Label Trial
120972|NCT01881737|O1|Outcome|Pregnenolone|"Twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.~Week 1 and 2: 100 mg Week 3 and 4: 200 mg Week 5 and 6: 300 mg Week 7 and 8: 400 mg Week 9 -12: 500 mg At the end of Week 12, pregnenolone was decreased by 50 mg twice a day every 3 days until it was discontinued.~If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs."
120973|NCT01881737|O1|Outcome|Pregnenolone|"Twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.~Week 1 and 2: 100 mg Week 3 and 4: 200 mg Week 5 and 6: 300 mg Week 7 and 8: 400 mg Week 9 -12: 500 mg At the end of Week 12, pregnenolone was decreased by 50 mg twice a day every 3 days until it was discontinued.~If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs."
120974|NCT01881737|O1|Outcome|Pregnenolone|"Twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.~Week 1 and 2: 100 mg Week 3 and 4: 200 mg Week 5 and 6: 300 mg Week 7 and 8: 400 mg Week 9 -12: 500 mg At the end of Week 12, pregnenolone was decreased by 50 mg twice a day every 3 days until it was discontinued.~If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs."
120975|NCT01881737|O1|Outcome|Pregnenolone|"Twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.~Week 1 and 2: 100 mg Week 3 and 4: 200 mg Week 5 and 6: 300 mg Week 7 and 8: 400 mg Week 9 -12: 500 mg At the end of Week 12, pregnenolone was decreased by 50 mg twice a day every 3 days until it was discontinued.~If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs."
120976|NCT01881737|O1|Outcome|Pregnenolone|"Pregnenolone up to 500 mg per day~Pregnenolone: With Baseline serving as approximately day 1, twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.~Week 1 and 2: 100 mg~Week 3 and 4: 200 mg~Week 5 and 6: 300 mg~Week 7 and 8: 400 mg~Week 9 -12: 500 mg~At the end of Week 12, pregnenolone was decreased by 50 mg twice a day every 3 days until it was discontinued.~If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs."
120977|NCT01881737|O1|Outcome|Pregnenolone|Open-Label study
120978|NCT01881737|E1|Reported Event|Pregnenolone|Pregnenolone was not associated with any severe adverse effects. Single episodes of tiredness (n = 1), diarrhea (n = 1), and depressive affect (n = 1) that could possibly be related to pregnenolone were reported. A few other adverse events with remote chance to be related to the medication were reported: increased excitement/agitation (n = 3), sleep problems (n = 1), drowsiness (n = 1), anorexia/decreased appetite (n = 2), increased motor activity (n = 1), sweating (n = 1), constipation (n = 1), diarrhea (n = 1), tremor (n = 1), and depressive affect (n = 1). No significant vital sign or EKG changes occurred in any study participants. No abnormal laboratory tests were caused by pregnenolone.
120979|NCT01881230|B4|Baseline|Total|Total of all reporting groups
120981|NCT01881230|B2|Baseline|Arm B: Nab-Paclitaxel + Carboplatin|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by IV administration followed by carboplatin area under the curve 2 (AUC 2) on Days 1 and 8 in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
120982|NCT01881230|B1|Baseline|Arm A: Nab-Paclitaxel Plus (+) Gemcitabine|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by intravenous (IV) administration followed by gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
120983|NCT01881230|P3|Participant Flow|Arm C: Gemcitabine + Carboplatin|Participants received gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration, followed by carboplatin AUC 2 on Days 1 and 8 by IV administration in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
120984|NCT01881230|P2|Participant Flow|Arm B: Nab-Paclitaxel + Carboplatin|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by IV administration followed by carboplatin area under the curve 2 (AUC 2) on Days 1 and 8 in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
120985|NCT01881230|P1|Participant Flow|Arm A: Nab-Paclitaxel Plus (+) Gemcitabine|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by intravenous (IV) administration followed by gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
120986|NCT01881230|O3|Outcome|Arm C: Gemcitabine + Carboplatin|Participants received gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration, followed by carboplatin AUC 2 on Days 1 and 8 by IV administration in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
120987|NCT01881230|O2|Outcome|Arm B: Nab-Paclitaxel + Carboplatin|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by IV administration followed by carboplatin area under the curve 2 (AUC 2) on Days 1 and 8 in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
120988|NCT01881230|O1|Outcome|Arm A: Nab-Paclitaxel + Gemcitabine|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by intravenous (IV) administration followed by gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration of each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment
120989|NCT01881230|O3|Outcome|Arm C: Gemcitabine + Carboplatin|Participants received gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration, followed by carboplatin AUC 2 on Days 1 and 8 by IV administration in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
120990|NCT01881230|O2|Outcome|Arm B: Nab-Paclitaxel + Carboplatin|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by IV administration followed by carboplatin area under the curve 2 (AUC 2) on Days 1 and 8 in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
120991|NCT01881230|O1|Outcome|Arm A: Nab-Paclitaxel + Gemcitabine|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by intravenous (IV) administration followed by gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration of each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment
120992|NCT01881230|O3|Outcome|Arm C: Gemcitabine + Carboplatin|Participants received gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration, followed by carboplatin AUC 2 on Days 1 and 8 by IV administration in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
121049|NCT01881113|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
121050|NCT01881113|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121051|NCT01881113|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
120993|NCT01881230|O2|Outcome|Arm B: Nab-Paclitaxel + Carboplatin|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by IV administration followed by carboplatin area under the curve 2 (AUC 2) on Days 1 and 8 in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
120994|NCT01881230|O1|Outcome|Arm A: Nab-Paclitaxel + Gemcitabine|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by intravenous (IV) administration followed by gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration of each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment
120995|NCT01881230|O3|Outcome|Arm C: Gemcitabine + Carboplatin|Participants received gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration, followed by carboplatin AUC 2 on Days 1 and 8 by IV administration in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
120996|NCT01881230|O2|Outcome|Arm B: Nab-Paclitaxel + Carboplatin|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by IV administration followed by carboplatin area under the curve 2 (AUC 2) on Days 1 and 8 in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
120997|NCT01881230|O1|Outcome|Arm A: Nab-Paclitaxel + Gemcitabine|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by intravenous (IV) administration followed by gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration of each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment
120998|NCT01881230|O3|Outcome|Arm C: Gemcitabine + Carboplatin|Participants received gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration, followed by carboplatin AUC 2 on Days 1 and 8 by IV administration in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
120999|NCT01881230|O2|Outcome|Arm B: Nab-Paclitaxel + Carboplatin|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by IV administration followed by carboplatin area under the curve 2 (AUC 2) on Days 1 and 8 in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
121000|NCT01881230|O1|Outcome|Arm A: Nab-Paclitaxel + Gemcitabine|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by intravenous (IV) administration followed by gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration of each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment
121001|NCT01881230|O3|Outcome|Arm C: Gemcitabine + Carboplatin|Participants received gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration, followed by carboplatin AUC 2 on Days 1 and 8 by IV administration in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
121002|NCT01881230|O2|Outcome|Arm B: Nab-Paclitaxel + Carboplatin|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by IV administration followed by carboplatin area under the curve 2 (AUC 2) on Days 1 and 8 in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
121003|NCT01881230|O1|Outcome|Arm A: Nab-Paclitaxel + Gemcitabine|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by intravenous (IV) administration followed by gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration of each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment
121004|NCT01881230|O3|Outcome|Arm C: Gemcitabine + Carboplatin|Participants received gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration, followed by carboplatin AUC 2 on Days 1 and 8 by IV administration in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
121052|NCT01881113|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121053|NCT01881113|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
121054|NCT01881113|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121005|NCT01881230|O2|Outcome|Arm B: Nab-Paclitaxel + Carboplatin|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by IV administration followed by carboplatin area under the curve 2 (AUC 2) on Days 1 and 8 in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.
121006|NCT01881230|O1|Outcome|Arm A: Nab-Paclitaxel + Gemcitabine|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by intravenous (IV) administration followed by gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration of each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment
121007|NCT01881230|E3|Reported Event|Arm C: Gemcitabine + Carboplatin|Participants received Gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration, followed by carboplatin AUC 2 on Days 1 and 8 by IV administration in each 21-day treatment cycle.
121008|NCT01881230|E2|Reported Event|Arm B: Nab-Paclitaxel + Carboplatin|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by IV administration followed by Carboplatin AUC 2 on Days 1 and 8 in each 21-day treatment cycle.
121009|NCT01881230|E1|Reported Event|Arm A: Nab-Paclitaxel + Gemcitabine|Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by intravenous (IV) administration followed by gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration in each 21-day treatment cycle.
121010|NCT01881126|B3|Baseline|Total|Total of all reporting groups
121011|NCT01881126|B2|Baseline|Travatan 0.004% and Timolol 0.5%|Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
121012|NCT01881126|B1|Baseline|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
121013|NCT01881126|P2|Participant Flow|Travatan 0.004% and Timolol 0.5%|Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
121014|NCT01881126|P1|Participant Flow|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
121015|NCT01881126|O2|Outcome|Travatan 0.004% and Timolol 0.5%|Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
121016|NCT01881126|O1|Outcome|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
121017|NCT01881126|E2|Reported Event|Travatan 0.004% and Timolol 0.5%|Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
121018|NCT01881126|E1|Reported Event|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
121019|NCT01881113|B3|Baseline|Total|Total of all reporting groups
121020|NCT01881113|B2|Baseline|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121021|NCT01881113|B1|Baseline|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
121022|NCT01881113|P2|Participant Flow|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121023|NCT01881113|P1|Participant Flow|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
121024|NCT01881113|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121025|NCT01881113|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
121026|NCT01881113|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121027|NCT01881113|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
121028|NCT01881113|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121029|NCT01881113|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
121030|NCT01881113|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121031|NCT01881113|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
121032|NCT01881113|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121033|NCT01881113|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
121034|NCT01881113|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121035|NCT01881113|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
121036|NCT01881113|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121037|NCT01881113|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
121038|NCT01881113|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121039|NCT01881113|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
121040|NCT01881113|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121041|NCT01881113|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
121042|NCT01881113|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121043|NCT01881113|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
121044|NCT01881113|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121045|NCT01881113|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
121046|NCT01881113|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121047|NCT01881113|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
121058|NCT01881113|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121059|NCT01881113|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
121060|NCT01881113|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121061|NCT01881113|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
121062|NCT01881113|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121063|NCT01881113|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
121064|NCT01881113|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121065|NCT01881113|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
121066|NCT01881113|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121067|NCT01881113|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
121068|NCT01881113|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121069|NCT01881113|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
121070|NCT01881113|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121071|NCT01881113|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
121072|NCT01881113|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121073|NCT01881113|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
121074|NCT01881113|E2|Reported Event|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
121075|NCT01881113|E1|Reported Event|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
121076|NCT01881087|B4|Baseline|Total|Total of all reporting groups
121077|NCT01881087|B3|Baseline|Levo-11.25|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
121078|NCT01881087|B2|Baseline|Levo-9.37|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
121079|NCT01881087|B1|Baseline|Levo-7.5 mg|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
121080|NCT01881087|P3|Participant Flow|Levo-11.25|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
121081|NCT01881087|P2|Participant Flow|Levo-9.37|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
121082|NCT01881087|P1|Participant Flow|Levo-7.5 mg|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
121083|NCT01881087|O3|Outcome|Levo-11.25|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
121084|NCT01881087|O2|Outcome|Levo-9.37|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
121085|NCT01881087|O1|Outcome|Levo-7.5 mg|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
121086|NCT01881087|O3|Outcome|Levo-11.25|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
121087|NCT01881087|O2|Outcome|Levo-9.37|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
121088|NCT01881087|O1|Outcome|Levo-7.5 mg|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
121089|NCT01881087|E3|Reported Event|Levo-11.25|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
121090|NCT01881087|E2|Reported Event|Levo-9.37|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
121091|NCT01881087|E1|Reported Event|Levo-7.5 mg|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose.~Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
121093|NCT01880840|B2|Baseline|Astepro 0.1% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily~137 mcg of azelastine hydrochloride: nasal spray"
121094|NCT01880840|B1|Baseline|Astepro 0.15% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily~205.5 mcg of azelastine hydrochloride: nasal spray"
121095|NCT01880840|P2|Participant Flow|Astepro 0.1%|azelastine hydrochloride 548 mcg nasal spray
121096|NCT01880840|P1|Participant Flow|Astepro 0.15%|azelastine hydrochloride 822mcg nasal spray
121097|NCT01880840|O2|Outcome|Astepro 0.1% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily~137 mcg of azelastine hydrochloride: nasal spray"
121098|NCT01880840|O1|Outcome|Astepro 0.15% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily~205.5 mcg of azelastine hydrochloride: nasal spray"
121099|NCT01880840|E2|Reported Event|Astepro 0.1% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily~137 mcg of azelastine hydrochloride: nasal spray"
121100|NCT01880840|E1|Reported Event|Astepro 0.15% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily~205.5 mcg of azelastine hydrochloride: nasal spray"
121101|NCT01880736|B5|Baseline|Total|Total of all reporting groups
121102|NCT01880736|B4|Baseline|IDeg OD Flexible Dosing and Stepwise Titration (Arm D)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the stepwise titration algorithm.
121103|NCT01880736|B3|Baseline|IDeg OD Flexible Dosing and Simple Titration (Arm C)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the simple titration algorithm.
121104|NCT01880736|B2|Baseline|IDeg OD Fixed Dosing and Stepwise Titration (Arm B)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen and the stepwise titration algorithm.
121105|NCT01880736|B1|Baseline|IDeg OD Fixed Dosing and Simple Titration (Arm A)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen and the simple titration algorithm.
121106|NCT01880736|P4|Participant Flow|IDeg OD Flexible Dosing and Stepwise Titration (Arm D)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the stepwise titration algorithm.
121107|NCT01880736|P3|Participant Flow|IDeg OD Flexible Dosing and Simple Titration (Arm C)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the simple titration algorithm.
121108|NCT01880736|P2|Participant Flow|IDeg OD Fixed Dosing and Stepwise Titration (Arm B)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen and the stepwise titration algorithm.
121109|NCT01880736|P1|Participant Flow|IDeg OD Fixed Dosing and Simple Titration (Arm A)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen and the simple titration algorithm.
121110|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121111|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121112|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121113|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
121273|NCT01880320|E1|Reported Event|CD0271 0.3% /CD1579 2.5% Gel|"Active arm~CD0271 0.3% / CD1579 2.5%"
121114|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121115|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121116|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121117|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
121118|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121119|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121120|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121121|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
121122|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121133|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
121274|NCT01880099|B4|Baseline|Total|Total of all reporting groups
121123|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121124|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121125|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
121126|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121127|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121128|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121129|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
121130|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121131|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121132|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121171|NCT01880697|P1|Participant Flow|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
121134|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121135|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121136|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121137|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
121138|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121139|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121140|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121141|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
121142|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121172|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
121173|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
121174|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
121143|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121144|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121145|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
121146|NCT01880736|E4|Reported Event|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121147|NCT01880736|E3|Reported Event|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121148|NCT01880736|E2|Reported Event|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
121149|NCT01880736|E1|Reported Event|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
121150|NCT01880723|B3|Baseline|Total|Total of all reporting groups
121151|NCT01880723|B2|Baseline|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
121152|NCT01880723|B1|Baseline|Healthy|Healthy Control subjects
121153|NCT01880723|P2|Participant Flow|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
121154|NCT01880723|P1|Participant Flow|Healthy|Healthy control subjects
121155|NCT01880723|O2|Outcome|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
121156|NCT01880723|O1|Outcome|Healthy|Healthy control subjects
121157|NCT01880723|O2|Outcome|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
121158|NCT01880723|O1|Outcome|Healthy|Healthy control subjects
121159|NCT01880723|O2|Outcome|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
121160|NCT01880723|O1|Outcome|Healthy|Healthy control subjects
121161|NCT01880723|O2|Outcome|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
121162|NCT01880723|O1|Outcome|Healthy|Healthy control subjects
121163|NCT01880723|O2|Outcome|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
121164|NCT01880723|O1|Outcome|Healthy|Healthy control subjects
121165|NCT01880723|E2|Reported Event|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
121166|NCT01880723|E1|Reported Event|Healthy|Healthy control subjects
121167|NCT01880697|B3|Baseline|Total|Total of all reporting groups
121168|NCT01880697|B2|Baseline|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
121169|NCT01880697|B1|Baseline|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
121170|NCT01880697|P2|Participant Flow|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
121175|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
121176|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
121177|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
121178|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
121179|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
121180|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
121181|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
121182|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
121183|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
121184|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
121185|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
121186|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
121187|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
121188|NCT01880697|E2|Reported Event|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
121189|NCT01880697|E1|Reported Event|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
121190|NCT01880515|B3|Baseline|Total|Total of all reporting groups
121191|NCT01880515|B2|Baseline|No Tetracycline|This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
121192|NCT01880515|B1|Baseline|Tetracycline|"Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations~Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW 2992"
121193|NCT01880515|P2|Participant Flow|No Tetracycline|This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
121194|NCT01880515|P1|Participant Flow|Tetracycline|"Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations (sunscreen and emollient cream)~Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW2992 (afatinib)"
121195|NCT01880515|O2|Outcome|No Tetracycline|This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
121196|NCT01880515|O1|Outcome|Tetracycline|"Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations (sunscreen and emollient cream)~Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW2992 whereas the non-intervention group will recieve general dermatological recomendations while on treatment with BIBW2992."
121197|NCT01880515|O2|Outcome|No Tetracycline|This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
121198|NCT01880515|O1|Outcome|Tetracycline|"Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations (sunscreen and emollient cream)~Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW 2992"
121199|NCT01880515|E2|Reported Event|No Tetracycline|This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
121200|NCT01880515|E1|Reported Event|Tetracycline|"Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations (sunscreen and emollient cream)~Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW 2992"
121201|NCT01880437|B4|Baseline|Total|Total of all reporting groups
121202|NCT01880437|B3|Baseline|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121203|NCT01880437|B2|Baseline|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121204|NCT01880437|B1|Baseline|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121205|NCT01880437|P3|Participant Flow|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121206|NCT01880437|P2|Participant Flow|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121207|NCT01880437|P1|Participant Flow|Poor Risk Cytogenetics|Participants with relapsed/refractory acute myeloid leukemia (AML) or relapsed/refractory high-risk myelodysplastic syndrome (MDS) falling under 'poor risk cytogenetics' subgroup received oral 150 milligrams (mg) dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121208|NCT01880437|O1|Outcome|Planned Cohort 2|Participants in Cohort 2 were planned to receive low-dose subcutaneous injections of cytarabine in combination with continuous daily vismodegib (150 mg orally).
121209|NCT01880437|O3|Outcome|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121210|NCT01880437|O2|Outcome|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121211|NCT01880437|O1|Outcome|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121212|NCT01880437|O3|Outcome|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121213|NCT01880437|O2|Outcome|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121214|NCT01880437|O1|Outcome|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121215|NCT01880437|O3|Outcome|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121216|NCT01880437|O2|Outcome|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121217|NCT01880437|O1|Outcome|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121218|NCT01880437|O3|Outcome|Neither Poor Risk Cytogenetics Nor FLT3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121219|NCT01880437|O2|Outcome|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121220|NCT01880437|O1|Outcome|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121221|NCT01880437|O3|Outcome|Neither Poor Risk Cytogenetics Nor FLT3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121222|NCT01880437|O2|Outcome|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121223|NCT01880437|O1|Outcome|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121224|NCT01880437|O3|Outcome|Neither Poor Risk Cytogenetics Nor FLT3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121225|NCT01880437|O2|Outcome|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121226|NCT01880437|O1|Outcome|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121227|NCT01880437|E3|Reported Event|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121228|NCT01880437|E2|Reported Event|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121229|NCT01880437|E1|Reported Event|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
121230|NCT01880424|B3|Baseline|Total|Total of all reporting groups
121231|NCT01880424|B2|Baseline|Placebo Arm|matching placebo capsules, oral, once daily
121232|NCT01880424|B1|Baseline|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
121233|NCT01880424|P2|Participant Flow|Placebo Arm|matching placebo capsules, oral, once daily
121234|NCT01880424|P1|Participant Flow|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
121235|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
121236|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
121237|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
121238|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
121239|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
121240|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
121241|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
121242|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
121243|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
121244|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
121245|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
121246|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
121247|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
121248|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
121249|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
121250|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
121251|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
121252|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
121253|NCT01880424|E2|Reported Event|Placebo Arm|matching placebo capsules, oral, once daily
121254|NCT01880424|E1|Reported Event|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
121255|NCT01880320|B4|Baseline|Total|Total of all reporting groups
121256|NCT01880320|B3|Baseline|Topical Gel Vehicle|"Placebo arm~Topical Gel Vehicle"
121257|NCT01880320|B2|Baseline|CD0271 0.1% / CD1579 2.5%|"Comparator arm~CD0271 0.1% / CD1579 2.5%"
121258|NCT01880320|B1|Baseline|CD0271 0.3% /CD1579 2.5% Gel|"Active arm~CD0271 0.3% / CD1579 2.5%"
121259|NCT01880320|P3|Participant Flow|Topical Gel Vehicle|"Placebo arm~Topical Gel Vehicle"
121260|NCT01880320|P2|Participant Flow|CD0271 0.1% / CD1579 2.5%|"Comparator arm~CD0271 0.1% / CD1579 2.5%"
121261|NCT01880320|P1|Participant Flow|CD0271 0.3% /CD1579 2.5% Gel|"Active arm~CD0271 0.3% / CD1579 2.5%"
121262|NCT01880320|O3|Outcome|Topical Gel Vehicle|"Placebo arm~Topical Gel Vehicle"
121263|NCT01880320|O2|Outcome|CD0271 0.1% / CD1579 2.5%|"Comparator arm~CD0271 0.1% / CD1579 2.5%"
121264|NCT01880320|O1|Outcome|CD0271 0.3% /CD1579 2.5% Gel|"Active arm~CD0271 0.3% / CD1579 2.5%"
121265|NCT01880320|O3|Outcome|Topical Gel Vehicle|"Placebo arm~Topical Gel Vehicle"
121266|NCT01880320|O2|Outcome|CD0271 0.1% / CD1579 2.5%|"Comparator arm~CD0271 0.1% / CD1579 2.5%"
121267|NCT01880320|O1|Outcome|CD0271 0.3% /CD1579 2.5% Gel|"Active arm~CD0271 0.3% / CD1579 2.5%"
121268|NCT01880320|O3|Outcome|Topical Gel Vehicle|"Placebo arm~Topical Gel Vehicle"
121269|NCT01880320|O2|Outcome|CD0271 0.1% / CD1579 2.5%|"Comparator arm~CD0271 0.1% / CD1579 2.5%"
121270|NCT01880320|O1|Outcome|CD0271 0.3% /CD1579 2.5% Gel|"Active arm~CD0271 0.3% / CD1579 2.5%"
121271|NCT01880320|E3|Reported Event|Topical Gel Vehicle|"Placebo arm~Topical Gel Vehicle"
121272|NCT01880320|E2|Reported Event|CD0271 0.1% / CD1579 2.5%|"Comparator arm~CD0271 0.1% / CD1579 2.5%"
121275|NCT01880099|B3|Baseline|Galantamine 16mg|"Galantamine extended release (16mg) will be given daily for 5 weeks starting at week 3 after a two week titration with 8mg galantamine.~Galantamine 16mg: 16mg of galatamine compared to placebo"
121276|NCT01880099|B2|Baseline|Galantamine 8mg|"Galantamine extended release (8mg) will be given daily for 7 weeks.~Galantamine 8mg: 8mg of galatamine compared to placebo"
121277|NCT01880099|B1|Baseline|Placebo|"Placebo (sugar Pill) will be given daily for 7 weeks.~placebo: placebo compared to 8mg of galatamine"
121278|NCT01880099|P3|Participant Flow|Galantamine 16mg|"Galantamine extended release (16mg) will be given daily for 5 weeks starting at week 3 after a two week titration with 8mg galantamine.~Galantamine 16mg: 16mg of galatamine compared to placebo"
121279|NCT01880099|P2|Participant Flow|Galantamine 8mg|"Galantamine extended release (8mg) will be given daily for 7 weeks.~Galantamine 8mg: 8mg of galatamine compared to placebo"
121280|NCT01880099|P1|Participant Flow|Placebo|"Placebo (sugar Pill) will be given daily for 7 weeks.~placebo: placebo compared to 8mg of galatamine"
121281|NCT01880099|O3|Outcome|Galantamine 16mg|"Galantamine extended release (16mg) will be given daily for 5 weeks starting at week 3 after a two week titration with 8mg galantamine.~Galantamine 16mg: 16mg of galatamine compared to placebo"
121282|NCT01880099|O2|Outcome|Galantamine 8mg|"Galantamine extended release (8mg) will be given daily for 7 weeks.~Galantamine 8mg: 8mg of galatamine compared to placebo"
121283|NCT01880099|O1|Outcome|Placebo|"Placebo (sugar Pill) will be given daily for 7 weeks.~placebo: placebo compared to 8mg of galatamine"
121284|NCT01880099|E3|Reported Event|Galantamine 16mg|"Galantamine extended release (16mg) will be given daily for 5 weeks starting at week 3 after a two week titration with 8mg galantamine.~Galantamine 16mg: 16mg of galatamine compared to placebo"
121285|NCT01880099|E2|Reported Event|Galantamine 8mg|"Galantamine extended release (8mg) will be given daily for 7 weeks.~Galantamine 8mg: 8mg of galatamine compared to placebo"
121286|NCT01880099|E1|Reported Event|Placebo|"Placebo (sugar Pill) will be given daily for 7 weeks.~placebo: placebo compared to 8mg of galatamine"
121287|NCT01880086|B3|Baseline|Total|Total of all reporting groups
121288|NCT01880086|B2|Baseline|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.~Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
121289|NCT01880086|B1|Baseline|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.~Clomiphene citrate"
121290|NCT01880086|P2|Participant Flow|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.~Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
121291|NCT01880086|P1|Participant Flow|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.~Clomiphene citrate"
121292|NCT01880086|O2|Outcome|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.~Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
121293|NCT01880086|O1|Outcome|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.~Clomiphene citrate"
121294|NCT01880086|O2|Outcome|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.~Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
121295|NCT01880086|O1|Outcome|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.~Clomiphene citrate"
121296|NCT01880086|O2|Outcome|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.~Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
121297|NCT01880086|O1|Outcome|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.~Clomiphene citrate"
122193|NCT01877421|B9|Baseline|Phase 1, 5a (20mg)|Subjects from phase 1, 5a (20mg) group
121298|NCT01880086|O2|Outcome|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.~Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
121299|NCT01880086|O1|Outcome|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.~Clomiphene citrate"
121300|NCT01880086|O2|Outcome|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.~Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
121301|NCT01880086|O1|Outcome|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.~Clomiphene citrate"
121302|NCT01880086|O2|Outcome|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.~Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
121303|NCT01880086|O1|Outcome|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.~Clomiphene citrate"
121304|NCT01880086|O2|Outcome|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.~Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
121305|NCT01880086|O1|Outcome|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.~Clomiphene citrate"
121306|NCT01880086|E2|Reported Event|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.~Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
121307|NCT01880086|E1|Reported Event|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.~Clomiphene citrate"
121308|NCT01879852|B3|Baseline|Total|Total of all reporting groups
121309|NCT01879852|B2|Baseline|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.~Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
121310|NCT01879852|B1|Baseline|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
121311|NCT01879852|P2|Participant Flow|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.~Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
121312|NCT01879852|P1|Participant Flow|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
136521|NCT01806857|O1|Outcome|Active Drug (Neudexta)|
121313|NCT01879852|O2|Outcome|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.~Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
121314|NCT01879852|O1|Outcome|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
121315|NCT01879852|O2|Outcome|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.~Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
121316|NCT01879852|O1|Outcome|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
121317|NCT01879852|O2|Outcome|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.~Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
121318|NCT01879852|O1|Outcome|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
121319|NCT01879852|O2|Outcome|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.~Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
121320|NCT01879852|O1|Outcome|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
121321|NCT01879852|E2|Reported Event|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.~Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
121322|NCT01879852|E1|Reported Event|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
121323|NCT01879800|B3|Baseline|Total|Total of all reporting groups
121324|NCT01879800|B2|Baseline|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .~Acceptance and Commitment Therapy plus Illness Management"
121325|NCT01879800|B1|Baseline|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
121346|NCT01879722|B10|Baseline|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
121347|NCT01879722|B9|Baseline|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121326|NCT01879800|P2|Participant Flow|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .~Acceptance and Commitment Therapy plus Illness Management"
121327|NCT01879800|P1|Participant Flow|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
121328|NCT01879800|O2|Outcome|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .~Acceptance and Commitment Therapy plus Illness Management"
121329|NCT01879800|O1|Outcome|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
121330|NCT01879800|O2|Outcome|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .~Acceptance and Commitment Therapy plus Illness Management"
121331|NCT01879800|O1|Outcome|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
121332|NCT01879800|O2|Outcome|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .~Acceptance and Commitment Therapy plus Illness Management"
121333|NCT01879800|O1|Outcome|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
121334|NCT01879800|E2|Reported Event|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .~Acceptance and Commitment Therapy plus Illness Management"
121335|NCT01879800|E1|Reported Event|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
121336|NCT01879735|B3|Baseline|Total|Total of all reporting groups
121337|NCT01879735|B2|Baseline|Bolus vs. Constant Infusion|Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. Two 11C-CSar PET/CT recordings were performed in each subject. One with bolus infusion and one with constant infusion.
121338|NCT01879735|B1|Baseline|ICG's Effect on 11C-CSar Transport|Examine the effect of indocyanine green (ICG) on the rate constants for the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG.
121339|NCT01879735|P2|Participant Flow|Bolus and Constant Infusion of 11C-CSar|Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. Two 11C-CSar PET/CT recordings were performed in each subject. One with bolus infusion and one with constant infusion.
121340|NCT01879735|P1|Participant Flow|ICG Infusion|Examine the effect of indocyanine green (ICG) on the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG.
121341|NCT01879735|O2|Outcome|Infusion Method|Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. Two 11C-CSar PET/CT recordings were performed in each subject. One with bolus infusion and one with constant infusion.
121342|NCT01879735|O1|Outcome|ICG Infusion|Examine the effect of indocyanine green (ICG) on the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG.
121343|NCT01879735|E2|Reported Event|Bolus vs. Constant Infusion|Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. Two 11C-CSar PET/CT recordings were performed in each subject. One with bolus infusion and one with constant infusion.
121344|NCT01879735|E1|Reported Event|ICG's Effect on 11C-CSar Transport|Examine the effect of indocyanine green (ICG) on the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG.
121345|NCT01879722|B11|Baseline|Total|Total of all reporting groups
122194|NCT01877421|B8|Baseline|Phase 1, 4a Placebo|Subjects from phase 1, 4a placebo group
121348|NCT01879722|B8|Baseline|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121349|NCT01879722|B7|Baseline|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121350|NCT01879722|B6|Baseline|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121351|NCT01879722|B5|Baseline|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121352|NCT01879722|B4|Baseline|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121353|NCT01879722|B3|Baseline|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121354|NCT01879722|B2|Baseline|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121355|NCT01879722|B1|Baseline|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia
121356|NCT01879722|P10|Participant Flow|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
121357|NCT01879722|P9|Participant Flow|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121358|NCT01879722|P8|Participant Flow|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121359|NCT01879722|P7|Participant Flow|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121360|NCT01879722|P6|Participant Flow|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121361|NCT01879722|P5|Participant Flow|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121362|NCT01879722|P4|Participant Flow|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121363|NCT01879722|P3|Participant Flow|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121364|NCT01879722|P2|Participant Flow|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121365|NCT01879722|P1|Participant Flow|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121366|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121367|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121368|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121369|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121370|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121371|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121372|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121373|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121374|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121375|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121376|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121377|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121378|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121379|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121380|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121381|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121382|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121383|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121384|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121385|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121386|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121387|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121388|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121389|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
122195|NCT01877421|B7|Baseline|Phase 1, 4a (10mg)|Subjects from phase 1, 4a (10mg) group
121390|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121391|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121392|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121393|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121394|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121395|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121396|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121397|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121398|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121399|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121400|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121401|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121402|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121403|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121404|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121405|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121406|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121407|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121408|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121409|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121410|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121411|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121412|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121413|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121414|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121415|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121416|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121417|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121418|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121419|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121420|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121421|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121422|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121423|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121424|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121425|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121426|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121427|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121428|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121429|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121430|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121431|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121432|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
122196|NCT01877421|B6|Baseline|Phase 1, 3a Placebo|Subjects from phase 1, 3a placebo gorup
121433|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121434|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121435|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121436|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121437|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121438|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121439|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121440|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121441|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121442|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121443|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121444|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121445|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121446|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121447|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121448|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121449|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121450|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121451|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121452|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121453|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121454|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121455|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121456|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121457|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121458|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121459|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121460|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121461|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121462|NCT01879722|O10|Outcome|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
121463|NCT01879722|O9|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121464|NCT01879722|O8|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121465|NCT01879722|O7|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121466|NCT01879722|O6|Outcome|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121467|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121468|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121469|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121470|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121471|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121472|NCT01879722|O10|Outcome|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
121473|NCT01879722|O9|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121474|NCT01879722|O8|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121475|NCT01879722|O7|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
122197|NCT01877421|B5|Baseline|Phase 1, 3a (6mg)|Subject from phase 1, 3a (6mg) group
121476|NCT01879722|O6|Outcome|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121477|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121478|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121479|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121480|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121481|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121482|NCT01879722|O10|Outcome|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
121483|NCT01879722|O9|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121484|NCT01879722|O8|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121485|NCT01879722|O7|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121486|NCT01879722|O6|Outcome|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121487|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121488|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121489|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121490|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121491|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121492|NCT01879722|O10|Outcome|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
121493|NCT01879722|O9|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121494|NCT01879722|O8|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121495|NCT01879722|O7|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121496|NCT01879722|O6|Outcome|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121497|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121498|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121499|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121500|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121501|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121502|NCT01879722|E10|Reported Event|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
121503|NCT01879722|E9|Reported Event|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121504|NCT01879722|E8|Reported Event|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121505|NCT01879722|E7|Reported Event|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
121506|NCT01879722|E6|Reported Event|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121507|NCT01879722|E5|Reported Event|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121508|NCT01879722|E4|Reported Event|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121509|NCT01879722|E3|Reported Event|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121510|NCT01879722|E2|Reported Event|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121511|NCT01879722|E1|Reported Event|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
121512|NCT01879683|B1|Baseline|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
121513|NCT01879683|P1|Participant Flow|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
121514|NCT01879683|O1|Outcome|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
121515|NCT01879683|O1|Outcome|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
121637|NCT01879345|O2|Outcome|BIA 2-093 - 2400 mg (Group 2)|4 tablets of BIA 2-093 600 mg BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg Oxcarbazepine is a BIA 2-093 metabolite
121516|NCT01879683|O1|Outcome|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
121517|NCT01879683|O1|Outcome|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
121518|NCT01879683|E1|Reported Event|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
121519|NCT01879618|B1|Baseline|FRAGMIN|Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
121520|NCT01879618|P1|Participant Flow|FRAGMIN|Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
121521|NCT01879618|O1|Outcome|FRAGMIN|Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
121522|NCT01879618|O1|Outcome|FRAGMIN|Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
121523|NCT01879618|E1|Reported Event|FRAGMIN|Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
121524|NCT01879579|B3|Baseline|Total|Total of all reporting groups
121525|NCT01879579|B2|Baseline|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
121526|NCT01879579|B1|Baseline|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
121527|NCT01879579|P2|Participant Flow|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
121528|NCT01879579|P1|Participant Flow|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
121529|NCT01879579|O1|Outcome|All Participants|Participants in both study arms (MITI and CBP).
121530|NCT01879579|O1|Outcome|All Participants|Participants in both study arms (MITI and CBP).
121531|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
121532|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
121533|NCT01879579|O2|Outcome|Insulin Titration Visits in the Clinic|Insulin titration visits that occurred in the clinic in both study arms (MITI and CBP arms).
121534|NCT01879579|O1|Outcome|Insulin Titration Visits by Phone|Insulin titration visits that occurred over the phone in both study arms (MITI and CBP arms).
121535|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
121536|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
121581|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
121582|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
121537|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
121538|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
121539|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
121540|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
121541|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
121542|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
121543|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
121544|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
121545|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
121546|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
121547|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
121548|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
121549|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
121550|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
121551|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
121583|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
121584|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
121552|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
121553|NCT01879579|E2|Reported Event|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
121554|NCT01879579|E1|Reported Event|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
121555|NCT01879553|B3|Baseline|Total|Total of all reporting groups
121556|NCT01879553|B2|Baseline|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
121557|NCT01879553|B1|Baseline|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
121558|NCT01879553|P2|Participant Flow|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
121559|NCT01879553|P1|Participant Flow|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
121560|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
121561|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
121562|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
121563|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
121564|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
121565|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
121566|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
121567|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
121568|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
121569|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
121570|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
121571|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
121572|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
121573|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
121574|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
121575|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
121576|NCT01879553|E3|Reported Event|Total|Total
121577|NCT01879553|E2|Reported Event|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
121578|NCT01879553|E1|Reported Event|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
121579|NCT01879540|B1|Baseline|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
121580|NCT01879540|P1|Participant Flow|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
122198|NCT01877421|B4|Baseline|Phase 1, 2a Placebo|Subjects from phase 1, 2a (4mg) group
121585|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
121586|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
121587|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
121588|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
121589|NCT01879540|E1|Reported Event|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
121590|NCT01879410|B3|Baseline|Total|Total of all reporting groups
121591|NCT01879410|B2|Baseline|FSC 250/50 mcg|Participants received FSC 250/50 µg BID in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
121592|NCT01879410|B1|Baseline|UMEC/VI 62.5/25 mcg|Participants received UMEC/VI 62.5/25 µg QD in the morning via a DPI and placebo in the morning and evening via a separate DPI for 12 weeks.
121593|NCT01879410|P2|Participant Flow|FSC 250/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 250/50 µg twice daily (BID) in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
121594|NCT01879410|P1|Participant Flow|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg)) once daily (QD) in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI for 12 weeks.
121595|NCT01879410|O2|Outcome|FSC 250/50 mcg|Participants received FSC 250/50 µg BID in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
121596|NCT01879410|O1|Outcome|UMEC/VI 62.5/25 mcg|Participants received UMEC/VI 62.5/25 µg QD in the morning via a DPI and placebo in the morning and evening via a separate DPI for 12 weeks.
121597|NCT01879410|O2|Outcome|FSC 250/50 mcg|Participants received FSC 250/50 µg BID in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
121598|NCT01879410|O1|Outcome|UMEC/VI 62.5/25 mcg|Participants received UMEC/VI 62.5/25 µg QD in the morning via a DPI and placebo in the morning and evening via a separate DPI for 12 weeks.
121599|NCT01879410|E2|Reported Event|FSC 250/50 mcg|Participants received FSC 250/50 µg BID in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
121600|NCT01879410|E1|Reported Event|UMEC/VI 62.5/25 mcg|Participants received UMEC/VI 62.5/25 µg QD in the morning via a DPI and placebo in the morning and evening via a separate DPI for 12 weeks.
121601|NCT01879371|B7|Baseline|Total|Total of all reporting groups
121602|NCT01879371|B6|Baseline|Ibu Lysinate / Ibu Acid / Ibu + Caf|Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
121603|NCT01879371|B5|Baseline|Ibu Lysinate/ Ibu + Caf / Ibu Acid|Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
121604|NCT01879371|B4|Baseline|Ibu Acid/ Ibu + Caf / Ibu Lysinate|Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
121605|NCT01879371|B3|Baseline|Ibu Acid / Ibu Lysinate/ Ibu + Caf|Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
121606|NCT01879371|B2|Baseline|Ibu + Caf / Ibu Lysinate / Ibu Acid|Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
121607|NCT01879371|B1|Baseline|Ibu + Caf / Ibu Acid / Ibu Lysinate|Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
121608|NCT01879371|P6|Participant Flow|Ibu Lysinate / Ibu Acid / Ibu + Caf|Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
121609|NCT01879371|P5|Participant Flow|Ibu Lysinate/ Ibu + Caf / Ibu Acid|Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
121610|NCT01879371|P4|Participant Flow|Ibu Acid/ Ibu + Caf / Ibu Lysinate|Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
121611|NCT01879371|P3|Participant Flow|Ibu Acid / Ibu Lysinate/ Ibu + Caf|Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
121612|NCT01879371|P2|Participant Flow|Ibu + Caf / Ibu Lysinate / Ibu Acid|Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
121613|NCT01879371|P1|Participant Flow|Ibu + Caf / Ibu Acid / Ibu Lysinate|Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
121614|NCT01879371|O3|Outcome|Ibuprofen Lysinate Film-coated Tablet|Ibuprofen lysinate (Nurofen® immedia) film-coated tablet; 400 mg Ibuprofen; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
121615|NCT01879371|O2|Outcome|Ibuprofen Acid Film-coated Tablet|400 mg Ibuprofen acid (Brufen®) film-coated tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
121616|NCT01879371|O1|Outcome|Ibuprofen + Caffeine (FDC) Tablet|400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
121617|NCT01879371|O3|Outcome|Ibuprofen Lysinate Film-coated Tablet|Ibuprofen lysinate (Nurofen® immedia) film-coated tablet; 400 mg Ibuprofen; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
121618|NCT01879371|O2|Outcome|Ibuprofen Acid Film-coated Tablet|400 mg Ibuprofen acid (Brufen®) film-coated tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
121619|NCT01879371|O1|Outcome|Ibuprofen + Caffeine (FDC) Tablet|400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
121620|NCT01879371|O3|Outcome|Ibuprofen Lysinate Film-coated Tablet|Ibuprofen lysinate (Nurofen® immedia) film-coated tablet; 400 mg Ibuprofen; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
121621|NCT01879371|O2|Outcome|Ibuprofen Acid Film-coated Tablet|400 mg Ibuprofen acid (Brufen®) film-coated tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
121622|NCT01879371|O1|Outcome|Ibuprofen + Caffeine (FDC) Tablet|400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
121623|NCT01879371|E3|Reported Event|Ibuprofen Lysinate Film-coated Tablet|Ibuprofen lysinate (Nurofen® immedia) film-coated tablet; 400 mg Ibuprofen; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
121624|NCT01879371|E2|Reported Event|Ibuprofen Acid Film-coated Tablet|400 mg Ibuprofen acid (Brufen®) film-coated tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
121625|NCT01879371|E1|Reported Event|Ibuprofen + Caffeine (FDC) Tablet|400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
121626|NCT01879345|B4|Baseline|Total|Total of all reporting groups
121627|NCT01879345|B3|Baseline|Placebo|PLC, Placebo
121628|NCT01879345|B2|Baseline|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg~BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
121629|NCT01879345|B1|Baseline|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg~BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
121630|NCT01879345|P3|Participant Flow|Placebo|PLC, Placebo
121631|NCT01879345|P2|Participant Flow|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg~BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
121632|NCT01879345|P1|Participant Flow|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg~BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
121633|NCT01879345|O2|Outcome|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg~BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
121634|NCT01879345|O1|Outcome|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg~BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
121635|NCT01879345|O2|Outcome|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg~BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
121636|NCT01879345|O1|Outcome|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg~BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
136522|NCT01806857|O2|Outcome|Matching Placebo|
121638|NCT01879345|O1|Outcome|BIA 2-093 - 1800 mg (Group 1)|3 tablets of BIA 2-093 600 mg BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093 Oxcarbazepine is a BIA 2-093 metabolite
121639|NCT01879345|O3|Outcome|Placebo|PLC, Placebo
121640|NCT01879345|O2|Outcome|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg~BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
121641|NCT01879345|O1|Outcome|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg~BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
121642|NCT01879345|E3|Reported Event|Placebo|PLC, Placebo
121643|NCT01879345|E2|Reported Event|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg~BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
121644|NCT01879345|E1|Reported Event|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg~BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
121645|NCT01879332|B4|Baseline|Total|Total of all reporting groups
121646|NCT01879332|B3|Baseline|BIA 2-093 3600 mg Once Daily|"Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3600 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
121647|NCT01879332|B2|Baseline|BIA 2-093 3000 mg Once Daily|"Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3000 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
121648|NCT01879332|B1|Baseline|Placebo|"Matching placebo tablets for oral administration~Placebo: Matching placebo tablets for oral administration"
121649|NCT01879332|P3|Participant Flow|Placebo|"Matching placebo tablets for oral administration~Placebo: Matching placebo tablets for oral administration"
121650|NCT01879332|P2|Participant Flow|BIA 2-093 3600 mg Once Daily|"Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3600 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
121651|NCT01879332|P1|Participant Flow|BIA 2-093 3000 mg Once Daily|"Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3000 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
121652|NCT01879332|O3|Outcome|Placebo|"Matching placebo tablets for oral administration~Placebo: Matching placebo tablets for oral administration"
121653|NCT01879332|O2|Outcome|BIA 2-093 3600 mg Once Daily|"Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3600 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
121654|NCT01879332|O1|Outcome|BIA 2-093 3000 mg Once Daily|"Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3000 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
121655|NCT01879332|E3|Reported Event|Placebo|"Matching placebo tablets for oral administration~Placebo: Matching placebo tablets for oral administration"
121656|NCT01879332|E2|Reported Event|BIA 2-093 3600 mg Once Daily|"Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3600 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
121657|NCT01879332|E1|Reported Event|BIA 2-093 3000 mg Once Daily|"Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3000 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
121658|NCT01879319|B3|Baseline|Total|Total of all reporting groups
121659|NCT01879319|B2|Baseline|Evolocumab AI/Pen|Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8).
121660|NCT01879319|B1|Baseline|Evolocumab AMD|Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8).
121661|NCT01879319|P2|Participant Flow|Evolocumab AI/Pen|Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 4 and 8.
121662|NCT01879319|P1|Participant Flow|Evolocumab AMD|Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 4 and 8.
121663|NCT01879319|O2|Outcome|Evolocumab AI/Pen|Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8).
121664|NCT01879319|O1|Outcome|Evolocumab AMD|Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8).
121665|NCT01879319|O2|Outcome|Evolocumab AI/Pen|Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8).
121666|NCT01879319|O1|Outcome|Evolocumab AMD|Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8).
121667|NCT01879319|E2|Reported Event|Evolocumab AI/Pen|Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8).
121668|NCT01879319|E1|Reported Event|Evolocumab AMD|Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8).
121669|NCT01879176|B3|Baseline|Total|Total of all reporting groups
121670|NCT01879176|B2|Baseline|Control|No filter will be installed on the CPB machine.
121671|NCT01879176|B1|Baseline|CytoSorb|For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1.
121672|NCT01879176|P2|Participant Flow|Control|No filter will be installed on the CPB machine.
121673|NCT01879176|P1|Participant Flow|CytoSorb|"For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1 .~CytoSorb"
121674|NCT01879176|O2|Outcome|Control|No filter will be installed on the CPB machine.
121675|NCT01879176|O1|Outcome|CytoSorb|For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1 .
121676|NCT01879176|E2|Reported Event|Control|No filter will be installed on the CPB machine.
121677|NCT01879176|E1|Reported Event|CytoSorb|"For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1 .~CytoSorb"
121678|NCT01879072|B1|Baseline|Allogeneic Hematopoietic Stem Cell Transplant|Participants received allogeneic hematopoietic stem cell transplantation
121679|NCT01879072|P1|Participant Flow|Allogeneic Hematopoietic Stem Cell Transplant|Participants received allogeneic hematopoietic stem cell transplantation
121680|NCT01879072|O1|Outcome|Allogeneic Hematopoietic Stem Cell Transplant|Participants received allogeneic hematopoietic stem cell transplantation
121681|NCT01879072|E1|Reported Event|Hematopoietic Stem Cell Transplant|
121682|NCT01879059|B1|Baseline|Exercise|"5 days of inactivity followed by a 1 day return to physical activity~Exercise: short period of inactivity (5 days) followed by a return to physical activity (1 day)"
121683|NCT01879059|P1|Participant Flow|Exercise|"5 days of inactivity followed by a 1 day return to physical activity~Exercise: short period of inactivity (5 days) followed by a return to physical activity (1 day)"
121684|NCT01879059|O1|Outcome|Exercise|"5 days of inactivity followed by a 1 day return to physical activity~Exercise: short period of inactivity (5 days) followed by a return to physical activity (1 day)"
121685|NCT01879059|E1|Reported Event|Exercise|"5 days of inactivity followed by a 1 day return to physical activity~Exercise: short period of inactivity (5 days) followed by a return to physical activity (1 day)"
121686|NCT01878825|B3|Baseline|Total|Total of all reporting groups
121687|NCT01878825|B2|Baseline|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
121688|NCT01878825|B1|Baseline|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
121689|NCT01878825|P2|Participant Flow|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
121690|NCT01878825|P1|Participant Flow|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
121691|NCT01878825|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
121692|NCT01878825|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
121693|NCT01878825|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
121694|NCT01878825|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
121695|NCT01878825|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
121696|NCT01878825|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
121697|NCT01878825|O2|Outcome|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
121698|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
121699|NCT01878825|O4|Outcome|Fluviral > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
121700|NCT01878825|O3|Outcome|Fluviral >60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
121701|NCT01878825|O2|Outcome|Fluviral 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
121702|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
121703|NCT01878825|O4|Outcome|Fluviral > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
121704|NCT01878825|O3|Outcome|Fluviral > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
121733|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121705|NCT01878825|O2|Outcome|Fluviral 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
121706|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
121707|NCT01878825|O4|Outcome|Fluviral >60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
121708|NCT01878825|O3|Outcome|Fluviral > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
121709|NCT01878825|O2|Outcome|Fluviral 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
121710|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
121711|NCT01878825|O4|Outcome|Fluviral > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
121712|NCT01878825|O3|Outcome|Fluviral >60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
121713|NCT01878825|O2|Outcome|Fluviral 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
121714|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
121715|NCT01878825|O2|Outcome|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
121716|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
121717|NCT01878825|O2|Outcome|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
121718|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
121719|NCT01878825|O2|Outcome|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
121720|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
121721|NCT01878825|O2|Outcome|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
121722|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
121723|NCT01878825|E2|Reported Event|Fluarix/Influsplit › 60 Years Group|Subjects aged › 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
121724|NCT01878825|E1|Reported Event|Fluarix/Influsplit 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
121725|NCT01878812|B3|Baseline|Total|Total of all reporting groups
121726|NCT01878812|B2|Baseline|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121727|NCT01878812|B1|Baseline|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121728|NCT01878812|P2|Participant Flow|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121729|NCT01878812|P1|Participant Flow|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121730|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121731|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121732|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121734|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121735|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121736|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121737|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121738|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121739|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121740|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121741|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121742|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121743|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121744|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121745|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121746|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121747|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121748|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121749|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121750|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121751|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121752|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121753|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121754|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121755|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121756|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121757|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121758|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121759|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121760|NCT01878812|E2|Reported Event|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121761|NCT01878812|E1|Reported Event|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
121762|NCT01878799|B3|Baseline|Total|Total of all reporting groups
121763|NCT01878799|B2|Baseline|Subjects With HIV and HCV Who Are Not on Antiretroviral Agents|Subjects with HIV and HCV who are not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
121764|NCT01878799|B1|Baseline|Subjects With HIV and HCV on Antiretroviral Agents|Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
121905|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
121765|NCT01878799|P2|Participant Flow|Subjects With HIV and HCV Who Are Not on Antiretroviral Agents|Subjects with HIV and HCV not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
121766|NCT01878799|P1|Participant Flow|Subjects With HIV and HCV on Antiretroviral Agents|Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
121767|NCT01878799|O2|Outcome|Subjects With HIV and HCV Who Are Not on Antiretroviral Agents|Subjects with HIV and HCV who are not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
121768|NCT01878799|O1|Outcome|Subjects With HIV and HCV on Antiretroviral Agents|Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
121769|NCT01878799|E2|Reported Event|Subjects With HIV and HCV Who Are Not on Antiretroviral Agents|Subjects with HIV and HCV who are not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
121770|NCT01878799|E1|Reported Event|Subjects With HIV and HCV on Antiretroviral Agents|Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
121771|NCT01878656|B3|Baseline|Total|Total of all reporting groups
121772|NCT01878656|B2|Baseline|Desflurane|"administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Desflurane: The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued."
121773|NCT01878656|B1|Baseline|Sevoflurane|"administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Sevoflurane: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued."
121774|NCT01878656|P2|Participant Flow|Desflurane|"administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Desflurane: The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued."
121775|NCT01878656|P1|Participant Flow|Sevoflurane|"administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Sevoflurane: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued."
121776|NCT01878656|O2|Outcome|Desflurane|"administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Desflurane: The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued."
121777|NCT01878656|O1|Outcome|Sevoflurane|"administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Sevoflurane: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued."
121778|NCT01878656|E2|Reported Event|Desflurane|"administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Desflurane: The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued."
121779|NCT01878656|E1|Reported Event|Sevoflurane|"administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Sevoflurane: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued."
121780|NCT01878604|B1|Baseline|Patients of HoFH|patients of Homozygous Familial Hypercholesterolemia
121781|NCT01878604|P1|Participant Flow|Homozygous Familial Hypercholesterolemia|"Gene Analysis for Homozygous Familial Hypercholesterolemia cases~Gene analysis: Gene analysis"
121782|NCT01878604|O1|Outcome|HoFH Patients|"patients of Homozygous Familial Hypercholesterolemia that meet the Inclusion criteria:~Cutaneous xanthomata before the age of ten years~LDLC > 13 mmol/L before treatment or > 7.76 mmol/L despite treatment~Phenotypic features in keeping with HeFH in both parents"
121783|NCT01878604|O1|Outcome|HoFH Patients|HoFH patients
121784|NCT01878604|E1|Reported Event|HoFH Patients|all HoFH patients enrolled in this study
121785|NCT01878526|B3|Baseline|Total|Total of all reporting groups
121786|NCT01878526|B2|Baseline|Omeprazole Plus Domperidone and Placebo of Alginic Acid|"Domperidone: domperidone (10 mg) 1 tab oral tid before meal~placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal"
121787|NCT01878526|B1|Baseline|Omeprazole Plus Alginic Acid and Placebo of Domperidone|"Alginic acid: Algycon 1 tab chew tid after meal~placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal"
121788|NCT01878526|P2|Participant Flow|Omeprazole Plus Domperidone and Placebo of Alginic Acid|"Domperidone: domperidone (10 mg) 1 tab oral tid before meal~placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal"
121789|NCT01878526|P1|Participant Flow|Omeprazole Plus Alginic Acid and Placebo of Domperidone|"Alginic acid: Algycon 1 tab chew tid after meal~placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal"
121790|NCT01878526|O2|Outcome|Omeprazole Plus Domperidone and Placebo of Alginic Acid|"Domperidone: domperidone (10 mg) 1 tab oral tid before meal~placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal"
121791|NCT01878526|O1|Outcome|Omeprazole Plus Alginic Acid and Placebo of Domperidone|"Alginic acid: Algycon 1 tab chew tid after meal~placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal"
121792|NCT01878526|O1|Outcome|Overall Systemic Sclerosis With GERD (Before Randomization)|omeprazole 20 mg bid ac for 4 weeks for overall systemic sclerosis with GERD
121793|NCT01878526|O2|Outcome|Omeprazole Plus Domperidone and Placebo of Alginic Acid|"Domperidone: domperidone (10 mg) 1 tab oral tid before meal~placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal"
121794|NCT01878526|O1|Outcome|Omeprazole Plus Alginic Acid and Placebo of Domperidone|"Alginic acid: Algycon 1 tab chew tid after meal~placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal"
121795|NCT01878526|O2|Outcome|Omeprazole Plus Domperidone and Placebo of Alginic Acid|"Domperidone: domperidone (10 mg) 1 tab oral tid before meal~placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal"
121796|NCT01878526|O1|Outcome|Omeprazole Plus Alginic Acid and Placebo of Domperidone|"Alginic acid: Algycon 1 tab chew tid after meal~placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal"
121797|NCT01878526|O2|Outcome|Omeprazole Plus Domperidone and Placebo of Alginic Acid|"Domperidone: domperidone (10 mg) 1 tab oral tid before meal~placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal"
121798|NCT01878526|O1|Outcome|Omeprazole Plus Alginic Acid and Placebo of Domperidone|"Alginic acid: Algycon 1 tab chew tid after meal~placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal"
121799|NCT01878526|E2|Reported Event|Omeprazole Plus Domperidone and Placebo of Alginic Acid|"Domperidone: domperidone (10 mg) 1 tab oral tid before meal~placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal"
121800|NCT01878526|E1|Reported Event|Omeprazole Plus Alginic Acid and Placebo of Domperidone|"Alginic acid: Algycon 1 tab chew tid after meal~placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal"
121801|NCT01878214|B3|Baseline|Total|Total of all reporting groups
121802|NCT01878214|B2|Baseline|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
121803|NCT01878214|B1|Baseline|Intervention Group|"Targeted messaging~Targeted messaging: 1 informational letter plus 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
121804|NCT01878214|P2|Participant Flow|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
121805|NCT01878214|P1|Participant Flow|Intervention Group|"Targeted messaging~Targeted messaging: 1 informational letter plus 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
121806|NCT01878214|O2|Outcome|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
121807|NCT01878214|O1|Outcome|Intervention Group|"Targeted messaging~Targeted messaging: 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
121808|NCT01878214|O2|Outcome|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
121809|NCT01878214|O1|Outcome|Intervention Group|"Targeted messaging~Targeted messaging: 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
121810|NCT01878214|O2|Outcome|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
121811|NCT01878214|O1|Outcome|Intervention Group|"Targeted messaging~Targeted messaging: 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
121812|NCT01878214|O2|Outcome|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
121813|NCT01878214|O1|Outcome|Intervention Group|"Targeted messaging~Targeted messaging: 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
121814|NCT01878214|O2|Outcome|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
121815|NCT01878214|O1|Outcome|Intervention Group|"Targeted messaging~Targeted messaging: 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
121816|NCT01878214|E2|Reported Event|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
121817|NCT01878214|E1|Reported Event|Intervention Group|"Targeted messaging~Targeted messaging: 1 informational letter plus 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
121818|NCT01878175|B1|Baseline|Functional Movement Retraining|15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
121819|NCT01878175|P1|Participant Flow|Functional Movement Retraining|15-week rehabilitation / exercise intervention, including visits at VA medical center, in-home with clinical personnel, and via telephone. Intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program focuses on lower extremity mobility, muscle stability and functional movement patterns. Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week.
121820|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
121821|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
121822|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
121823|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
121824|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
121825|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
121826|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
121827|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
121828|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
121829|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
121830|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
121906|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
121831|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
121832|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
121833|NCT01878175|O1|Outcome|Functional Movement Retraining|15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
121834|NCT01878175|E1|Reported Event|Functional Movement Retraining|15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
121835|NCT01878149|B3|Baseline|Total|Total of all reporting groups
121836|NCT01878149|B2|Baseline|eXtreme Lumbar Interbody Fusion (XLIF®)|This study included adult men and women (> 18 years old) who received a lateral lumbar interbody fusion (LLIF) with the XLIF® spinal procedure. XLIF® is intended to treat patients with conditions who typically require fusion at the lumbar levels for degenerative disc disease (DDD).
121837|NCT01878149|B1|Baseline|VEO® Lateral Access and Interbody Fusion System|This study included adult men and women (> 18 years old) who received a lateral lumbar interbody fusion (LLIF) with the VEO® spinal procedure. VEO® is intended to treat patients with conditions who typically require fusion at the lumbar levels for degenerative disc disease (DDD).
121838|NCT01878149|P2|Participant Flow|eXtreme Lumbar Interbody Fusion (XLIF®)|The eXtreme lumbar interbody fusion (XLIF®) is the brand name of the LLIF system distributed by NuVasive®, Inc.When the XLIF® system is used for LLIF, the patient is placed in the lateral decubitus position and the retroperitoneal space is accessed through blunt dissection. Using proprietary neuromonitoring, a series of graduated muscle dilators are advanced through the psoas muscle down to the disc space at the lumbar level of interest. Real-time EMG evoked potential values indicate proximity of motor nerves to direct safe dilator placement. A guidewire is placed into the disc space through the initial cannulated dilator to fix retractor placement. A psoas muscle retractor system is inserted over the dilators and blades are carefully opened over the disc space in the caudal-cephalad and anterior directions under direct live EMG. Upon achieving sufficient disc space exposure, standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
121839|NCT01878149|P1|Participant Flow|VEO® Lateral Access and Interbody Fusion System|VEO® is the brand name for the Baxano Surgical LLIF system, which employs traditional LLIF patient positioning, disc space preparation, implant placement, and is compatible with neuromonitoring. The VEO® system was developed with an initial, radiolucent retractor that is placed at the psoas fascia and held in place with an articulated arm. Dissection through the psoas is then performed with direct vision in conjunction with EMG. The psoas muscle is split anterior-posterior along muscle fiber lines and the retraction is performed with two independent blades. Insertion depth may be varied to avoid muscle creep, and the toed-out blade tips are positioned under the psoas to hold the system in place. An inner sleeve is inserted to lock the blades in place at the desired radial tension for a customizable disc space exposure. Standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
121840|NCT01878149|O2|Outcome|eXtreme Lumbar Interbody Fusion (XLIF®)|The eXtreme lumbar interbody fusion (XLIF®) is the brand name of the LLIF system distributed by NuVasive®, Inc. in 2001. When the XLIF® system is used for LLIF, the patient is placed in the lateral decubitus position and the retroperitoneal space is accessed through blunt dissection. Using proprietary neuromonitoring, a series of graduated muscle dilators are advanced through the psoas muscle down to the disc space at the lumbar level of interest. Real-time EMG evoked potential values indicate proximity of motor nerves to direct safe dilator placement. A guidewire is placed into the disc space through the initial cannulated dilator to fix retractor placement. A psoas muscle retractor system is inserted over the dilators and the blades are carefully opened over the disc space in the caudal-cephalad and anterior directions under direct live EMG. Upon achieving sufficient disc space exposure, standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
121841|NCT01878149|O1|Outcome|VEO® Lateral Access and Interbody Fusion System|VEO® is the brand name for the LLIF system introduced by Baxano Surgical® in 2011. The VEO Lateral system employs traditional LLIF patient positioning, disc space preparation, implant placement, and is compatible with neuromonitoring. However, the VEO® system posesses a radiolucent retractor that is placed at the psoas fascia and held in place with an articulated arm. This retractor was developed to address the reliance on EMG neuromonitoring alone with traditional LLIF approaches to avoid injury to lumbar plexus nerve roots, particularly as EMG is limited to monitoring motor nerves. Moreover, there was a desire to avoid reliance on fluoroscopy alone to determine retractor placement, without significant assessment of intervening anatomy.
136523|NCT01806857|O1|Outcome|Active Drug (Neudexta)|
121842|NCT01878149|E2|Reported Event|eXtreme Lumbar Interbody Fusion (XLIF®)|The eXtreme lumbar interbody fusion (XLIF®) is the brand name of the LLIF system distributed by NuVasive®, Inc. in 2001. When the XLIF® system is used for LLIF, the patient is placed in the lateral decubitus position and the retroperitoneal space is accessed through blunt dissection. Using proprietary neuromonitoring, a series of graduated muscle dilators are advanced through the psoas muscle down to the disc space at the lumbar level of interest. Real-time EMG evoked potential values indicate proximity of motor nerves to direct safe dilator placement. A guidewire is placed into the disc space through the initial cannulated dilator to fix retractor placement. A psoas muscle retractor system is inserted over the dilators and the blades are carefully opened over the disc space in the caudal-cephalad and anterior directions under direct live EMG. Upon achieving sufficient disc space exposure, standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
121843|NCT01878149|E1|Reported Event|VEO® Lateral Access and Interbody Fusion System|VEO® is the brand name for the LLIF system introduced by Baxano Surgical® in 2011. The VEO® Lateral system employs traditional LLIF patient positioning, disc space preparation, implant placement, and is compatible with neuromonitoring. However, the VEO® system posesses a radiolucent retractor that is placed at the psoas fascia and held in place with an articulated arm. This retractor was developed to address the reliance on EMG neuromonitoring alone with traditional LLIF approaches to avoid injury to lumbar plexus nerve roots, particularly as EMG is limited to monitoring motor nerves. Moreover, there was a desire to avoid reliance on fluoroscopy alone to determine retractor placement, without significant assessment of intervening anatomy.
121844|NCT01878097|B3|Baseline|Total|Total of all reporting groups
121845|NCT01878097|B2|Baseline|Control Training|
121846|NCT01878097|B1|Baseline|Green Dot Bystander Training|"26 high schools: 13 receiving Green Dot intervention and 13 no intervention~Green Dot Bystander Intevention: Intervention allocated at the school level"
121847|NCT01878097|P2|Participant Flow|Control|13 high school receiving no bystander training (no intervention)
121848|NCT01878097|P1|Participant Flow|Green Dot Bystander Training|"13 receiving Green Dot intervention~Green Dot Bystander Intevention: Intervention allocated at the school level"
121849|NCT01878097|O2|Outcome|Control|No bystander intervention
121850|NCT01878097|O1|Outcome|Green Dot Bystander Training|Phase one and two.
121851|NCT01878097|O2|Outcome|Control|No bystander intervention
121852|NCT01878097|O1|Outcome|Green Dot Bystander Training|Phase one and two.
121853|NCT01878097|O2|Outcome|Control|No bystander intervention
121854|NCT01878097|O1|Outcome|Green Dot Bystander Training|Phase one and two.
121855|NCT01878097|E2|Reported Event|Control|In 13 Kentucky region , 2 demographically comparable high schools were recruited to participate in GreenDot intervention as either the intervention or control site. Schools were randomly assigned to the intervention. Control schools received no additional programming on their campus.
121856|NCT01878097|E1|Reported Event|GreenDot|"Experimental: GreenDot Bystander Training GreenDot is a bystander intervention program that empowers students to actively question peer support for sexual violence (SV) and become change agents who play a significant role in preventing sexual violence."
121857|NCT01877941|B1|Baseline|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).~Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.~Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest."
121858|NCT01877941|P1|Participant Flow|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).~Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.~Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest."
121859|NCT01877941|O1|Outcome|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).~Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.~Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest."
121860|NCT01877941|O1|Outcome|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).~Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.~Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest.~Estimated Continuous Cardiac Output (esCCO): Sensors are placed on the arm, finger and leg to calculate Pulse Wave Transit Time (PWTT); the time it takes for the pulse of the heartbeat to travel through the body."
121907|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
138934|NCT01791725|E3|Reported Event|Placebo|"Placebo BID~Placebo"
121861|NCT01877941|O1|Outcome|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).~Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.~Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest.~Estimated Continuous Cardiac Output (esCCO): Sensors are placed on the arm, finger and leg to calculate Pulse Wave Transit Time (PWTT); the time it takes for the pulse of the heartbeat to travel through the body."
121862|NCT01877941|E1|Reported Event|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored during surgery and during post-surgical recovery. For instance, patients with ischemic heart disease undergoing cardiac bypass graft or percutaneous coronary intervention.~No adverse events."
121863|NCT01877720|B1|Baseline|Total Enrolled Patients|
121864|NCT01877720|P2|Participant Flow|NAVA-PS|"noninvasive NAVA first for 15 minutes and then PSV for 15 minutes~crossover of noninvasive respiratory support with NAVA mode and PSV"
121865|NCT01877720|P1|Participant Flow|PS-NAVA|"noninvasive PSV first for 15 minutes and then NAVA for 15 minutes~crossover of noninvasive respiratory support with NAVA mode and PSV"
121866|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
121867|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
121868|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
121869|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
121870|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
121871|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
121872|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
121873|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
121874|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
121875|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
121876|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
121877|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
121878|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
121879|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
121880|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
121881|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
121882|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
121883|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
121884|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
121885|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
121886|NCT01877720|E2|Reported Event|NIV-PS|non-invasive PS
121887|NCT01877720|E1|Reported Event|NIV-NAVA|non-invasive NAVA
121888|NCT01877668|B6|Baseline|Total|Total of all reporting groups
121889|NCT01877668|B5|Baseline|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
121890|NCT01877668|B4|Baseline|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
121891|NCT01877668|B3|Baseline|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
121892|NCT01877668|B2|Baseline|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
121893|NCT01877668|B1|Baseline|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
121894|NCT01877668|P5|Participant Flow|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
121895|NCT01877668|P4|Participant Flow|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
121896|NCT01877668|P3|Participant Flow|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
121897|NCT01877668|P2|Participant Flow|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
121898|NCT01877668|P1|Participant Flow|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
121899|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
121900|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
121901|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
121902|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
121903|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
121904|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
121908|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
121909|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
121910|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
121911|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
121912|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
121913|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
121914|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
121915|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
121916|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
121917|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
121918|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
121919|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
121920|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
121921|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
121922|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
121923|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
121924|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
121925|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
121926|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
121927|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
121928|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
121929|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
121930|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
121931|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
121932|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
121933|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
121934|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
121935|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
121936|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
121937|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
121938|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
121939|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
121940|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
121941|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
121942|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
121943|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
121944|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
121945|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
121946|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
121947|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
121948|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
121949|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
121950|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
121951|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
121952|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
121953|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
121954|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
121955|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
121956|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
121957|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
121958|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
121959|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
121960|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
121961|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
121962|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
121963|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
121964|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
121965|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
121966|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
121967|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
121968|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
121969|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
121970|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
121971|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
121972|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
122192|NCT01877421|B10|Baseline|Phase 1, 5a Placebo|Subjects from phase1, 5a placebo group
121973|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
121974|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
121975|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
121976|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
121977|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
121978|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
121979|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
121980|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
121981|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
121982|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
121983|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
121984|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
121985|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
121986|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
121987|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
121988|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
121989|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
121990|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
121991|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
121992|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
121993|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
121994|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
121995|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
121996|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
121997|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
121998|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
121999|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122000|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
122001|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
122002|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
122003|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
122004|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
122005|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122006|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
122007|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
122008|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
122009|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
122010|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
122011|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122012|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
122013|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
122014|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
122015|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
122016|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
122017|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122018|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
122019|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
122020|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
122021|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
122022|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
122023|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122024|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
122025|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
122026|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
122027|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
122028|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
122029|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122030|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
122031|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
122032|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
122033|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
122034|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
122035|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122036|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
122037|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
122038|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
122039|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
122040|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
122041|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122042|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
122043|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
122044|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
122045|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
122046|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
122047|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122048|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
122049|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
122050|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122051|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
122052|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
122053|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122054|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
122055|NCT01877668|O4|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
122056|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
122057|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122058|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
122059|NCT01877668|O4|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
122060|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
122061|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122062|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
122063|NCT01877668|O4|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
122064|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
122065|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122066|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
122067|NCT01877668|O4|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
122068|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
122069|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122070|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
122071|NCT01877668|O4|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
122072|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
122073|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122074|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
122075|NCT01877668|O4|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
122076|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
122077|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122078|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
122079|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
122080|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122081|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
122082|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
122083|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122084|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
122085|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
122086|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
122087|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
122088|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
122089|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122090|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
122091|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
122092|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
122093|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
122094|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
122095|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122096|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
122097|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
122098|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122099|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
122100|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
122101|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122102|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
122103|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122104|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
122105|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
122106|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122107|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
122108|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
122109|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122110|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
122111|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122112|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
122113|NCT01877668|O4|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
122114|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
122115|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122116|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
122117|NCT01877668|O4|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
122118|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
122119|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122120|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
122121|NCT01877668|E5|Reported Event|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
122122|NCT01877668|E4|Reported Event|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
122123|NCT01877668|E3|Reported Event|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
122124|NCT01877668|E2|Reported Event|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
122125|NCT01877668|E1|Reported Event|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
122126|NCT01877642|B3|Baseline|Total|Total of all reporting groups
122127|NCT01877642|B2|Baseline|All Crossover Subjects|All 6 crossover treatment sequences
122128|NCT01877642|B1|Baseline|Open Label Subjects|Open label portion of study
122129|NCT01877642|P7|Participant Flow|Treatment Sequence CBA|Treatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg
122130|NCT01877642|P6|Participant Flow|Treatment Sequence CAB|Treatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg
122131|NCT01877642|P5|Participant Flow|Treatment Sequence BAC|Treatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg
122132|NCT01877642|P4|Participant Flow|Treatment Sequence BCA|Treatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg
122133|NCT01877642|P3|Participant Flow|Treatment Sequence ACB|Treatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg
122134|NCT01877642|P2|Participant Flow|Treatment Sequence ABC|Treatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg
122135|NCT01877642|P1|Participant Flow|Open Label (Lorazepam 1 mg + Inhaled Loxapine 10 mg)|"Inhaled Staccato loxapine 10 mg + IM lorazepam 1 mg~Lorazepam 1 mg IM: Lorazepam 1 mg intramuscular~Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg"
122136|NCT01877642|O2|Outcome|Lorazepam+Loxapine / Loxapine|Lorazepam 1 mg IM + Inhaled Staccato Loxapine 10 mg compared to Inhaled Loxapine 10 mg
122137|NCT01877642|O1|Outcome|Lorazepam+Loxapine / Lorazepam|Lorazepam 1 mg IM + Inhaled Staccato Loxapine 10 mg compared to Lorazepam 1 mg IM
122138|NCT01877642|O2|Outcome|Lorazepam+Loxapine / Loxapine|Lorazepam 1 mg IM + Inhaled Staccato Loxapine 10 mg compared to Inhaled Loxapine 10 mg
122139|NCT01877642|O1|Outcome|Lorazepam+Loxapine / Lorazepam|Lorazepam 1 mg IM + Inhaled Staccato Loxapine 10 mg compared to Lorazepam 1 mg IM
122140|NCT01877642|O2|Outcome|Lorazepam+Loxapine / Loxapine|Lorazepam 1 mg IM + Inhaled Staccato Loxapine 10 mg compared to Inhaled Loxapine 10 mg
122141|NCT01877642|O1|Outcome|Lorazepam+Loxapine / Lorazepam|Lorazepam 1 mg IM + Inhaled Staccato Loxapine 10 mg compared to Lorazepam 1 mg IM
122142|NCT01877642|O2|Outcome|Lorazepam+Loxapine / Loxapine|Lorazepam 1 mg IM + Inhaled Staccato Loxapine 10 mg compared to Inhaled Loxapine 10 mg
122143|NCT01877642|O1|Outcome|Lorazepam+Loxapine / Lorazepam|Lorazepam 1 mg IM + Inhaled Staccato Loxapine 10 mg compared to Lorazepam 1 mg IM
122144|NCT01877642|O2|Outcome|Lorazepam+Loxapine / Loxapine|Lorazepam 1 mg IM + Inhaled Staccato Loxapine 10 mg compared to Inhaled Loxapine 10 mg
122145|NCT01877642|O1|Outcome|Lorazepam+Loxapine / Lorazepam|Lorazepam 1 mg IM + Inhaled Staccato Loxapine 10 mg compared to Lorazepam 1 mg IM
122146|NCT01877642|O2|Outcome|Lorazepam+Loxapine / Loxapine|Lorazepam 1 mg IM + Inhaled Staccato Loxapine 10 mg compared to Inhaled Loxapine 10 mg
122147|NCT01877642|O1|Outcome|Lorazepam+Loxapine / Lorazepam|Lorazepam 1 mg IM + Inhaled Staccato Loxapine 10 mg compared to Lorazepam 1 mg IM
122148|NCT01877642|O2|Outcome|Lorazepam+Loxapine / Loxapine|Lorazepam 1 mg IM + Inhaled Staccato Loxapine 10 mg compared to Inhaled Loxapine 10 mg
122149|NCT01877642|O1|Outcome|Lorazepam+Loxapine / Lorazepam|Lorazepam 1 mg IM + Inhaled Staccato Loxapine 10 mg compared to Lorazepam 1 mg IM
122150|NCT01877642|O1|Outcome|Open Label Group|Lorazepam 1 mg IM + Inhaled loxapine 10 mg
122151|NCT01877642|E4|Reported Event|Inhaled Loxapine 10 mg|"Inhaled Staccato loxapine 10 mg + IM placebo~Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg~Placebo IM: intramuscular placebo to mimic lorazepam 1 mg IM"
122152|NCT01877642|E3|Reported Event|Lorazepam 1 mg IM + Inhaled Loxapine 10 mg|"Lorazepam 1 mg IM + Inhaled Staccato loxapine 10 mg~Lorazepam 1 mg IM: Lorazepam 1 mg intramuscular~Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg"
122153|NCT01877642|E2|Reported Event|Lorazepam 1 mg IM|"Lorazepam 1 mg IM + Inhaled placebo~Lorazepam 1 mg IM: Lorazepam 1 mg intramuscular~Inhaled Placebo: Inhaler with no drug in it to mimic the ADASUVE inhaler"
122154|NCT01877642|E1|Reported Event|Open Label (Lorazepam 1 mg + Inhaled Loxapine 10 mg)|"Inhaled Staccato loxapine 10 mg + IM lorazepam 1 mg~Lorazepam 1 mg IM: Lorazepam 1 mg intramuscular~Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg"
122155|NCT01877564|B3|Baseline|Total|Total of all reporting groups
122156|NCT01877564|B2|Baseline|Group 2 - No Treatment|no metformin for 14-21 days
122157|NCT01877564|B1|Baseline|Group 1 - Metformin|"oral metformin at 500 mg twice a day for 14-21 days followed by surgery~Metformin"
122158|NCT01877564|P2|Participant Flow|Group 2 - No Treatment|no metformin for 14-21 days
122159|NCT01877564|P1|Participant Flow|Group 1 - Metformin|"oral metformin at 500 mg twice a day for 14-21 days followed by surgery~Metformin"
122160|NCT01877564|O2|Outcome|Group 2 - No Treatment|no metformin for 14-21 days
122161|NCT01877564|O1|Outcome|Group 1 - Metformin|"oral metformin at 500 mg twice a day for 14-21 days followed by surgery~Metformin"
122162|NCT01877564|E2|Reported Event|Group 2 - No Treatment|no metformin for 14-21 days
122163|NCT01877564|E1|Reported Event|Group 1 - Metformin|"oral metformin at 500 mg twice a day for 14-21 days followed by surgery~Metformin"
122164|NCT01877538|B1|Baseline|[11C]Donepezil PET|"[11C]donepezil is a radiopharmaceutical used with Positron Emission Tomography (PET) imaging. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system~[11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil~7 healthy control subjects were recruited to this study."
122165|NCT01877538|P1|Participant Flow|[11C]Donepezil|"[11C]donepezil is a radiopharmaceutical. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system~[11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil~7 healthy control subjects were scanned in this preliminary pilot study."
122166|NCT01877538|O1|Outcome|[11C]Donepezil PET|"[11C]donepezil is a radiopharmaceutical. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system~[11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil"
122167|NCT01877538|O1|Outcome|[11C]Donepezil PET|"[11C]donepezil is a radiopharmaceutical. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system~[11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil"
122168|NCT01877538|E1|Reported Event|[11C]Donepezil|"[11C]donepezil is a radiopharmaceutical. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system~[11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil~7 healthy controls were PET scanned in this preliminary study.~No adverse events were detected."
122169|NCT01877421|B33|Baseline|Total|Total of all reporting groups
122170|NCT01877421|B32|Baseline|Phase 2, 7b Placebo|Subjects from phase 2, 7b placebo group
122171|NCT01877421|B31|Baseline|Phase 2, 7b (75mg)|Subjects from phase 2, 7b (75mg) group
122172|NCT01877421|B30|Baseline|Phase 2, 6b Placebo|Subjects from phase 2, 6b placebo group
122173|NCT01877421|B29|Baseline|Phase 2, 6b (50mg)|Subjects from phase 2, 6b (50mg) group
122174|NCT01877421|B28|Baseline|Phase 2, 5b Placebo|Subjects from phase 2, 5b placebo group
122175|NCT01877421|B27|Baseline|Phase 2, 5b (30mg)|Subjects from phase 2, 5b (30mg) group
122176|NCT01877421|B26|Baseline|Phase 2, 4b Placebo|Subjects from phase 2, 4b placebo group
122177|NCT01877421|B25|Baseline|Phase 2, 4b (20mg)|Subjects from phase 2, 4b (20mg) group
122178|NCT01877421|B24|Baseline|Phase 2, 3b Placebo|Subjects from phase 2, 3b placebo group
122179|NCT01877421|B23|Baseline|Phase 2, 3b (10mg)|Subjects from phase 2, 3b (10mg) group
122180|NCT01877421|B22|Baseline|Phase 2, 2b Placebo|Subjects from phase 2, 2b placebo group
122181|NCT01877421|B21|Baseline|Phase 2, 2b (6mg)|Subjects from phase 2, 2b (6mg) group
122182|NCT01877421|B20|Baseline|Phase 2, 1b Placebo|Subjects from phase 2, 1b placebo
122183|NCT01877421|B19|Baseline|Phase 2, 1b (4mg)|Subjects from phase 2, 1b (4mg) group
122184|NCT01877421|B18|Baseline|Phase 1, 9a Placebo|Subjects from phase 1, 9a placebo group
122185|NCT01877421|B17|Baseline|Phase 1, 9a (100mg)|Subjects from phase 1, 9a (100mg) group
122186|NCT01877421|B16|Baseline|Phase 1, 8a Placebo|Subjects from phase 1, 8a placebo group
122187|NCT01877421|B15|Baseline|Phase 1, 8a (75mg)|Subjects from phase 1, 8a (75mg) group
122188|NCT01877421|B14|Baseline|Phase 1, 7a Placebo|Subjects from phase 1, 7a placebo group
122189|NCT01877421|B13|Baseline|Phase 1, 7a (50mg)|Subjects from phase 1, 7a (50mg) group
122190|NCT01877421|B12|Baseline|Phase 1, 6a Placebo|Subjects from phase 1, 6a placebo group
122191|NCT01877421|B11|Baseline|Phase 1, 6a (30mg)|Subjects from phase 1, 6a (30mg) group
122199|NCT01877421|B3|Baseline|Phase 1, 2a (4mg)|Subjects from phase 1, 2a (4mg) group
122200|NCT01877421|B2|Baseline|Phase 1, 1a Placebo|Subjects from phase 1, 1a placebo group
122201|NCT01877421|B1|Baseline|Phase 1, 1a (2mg)|Subjects from phase 1, 1a (2mg) group
122202|NCT01877421|P18|Participant Flow|100mg Placebo|100mg Placebo
122203|NCT01877421|P17|Participant Flow|100mg KSL-W|100mg KSL-W
122204|NCT01877421|P16|Participant Flow|75mg Placebo|75mg Placebo
122205|NCT01877421|P15|Participant Flow|75mg KSL-W|75mg KSL-W
122206|NCT01877421|P14|Participant Flow|50mg Placebo|50mg Placebo
122207|NCT01877421|P13|Participant Flow|50mg KSL-W|50mg KSL-W
122208|NCT01877421|P12|Participant Flow|30mg Placebo|30mg Placebo
122209|NCT01877421|P11|Participant Flow|30mg KSL-W|30mg KSL-W
122210|NCT01877421|P10|Participant Flow|20mg Placebo|20mg Placebo
122211|NCT01877421|P9|Participant Flow|20mg KSL-W|20mg KSL-W
122212|NCT01877421|P8|Participant Flow|10mg Placebo|10mg Placebo
122213|NCT01877421|P7|Participant Flow|10mg KSL-W|10mg KSL-W
122214|NCT01877421|P6|Participant Flow|6mg Placebo|6mg Placebo
122215|NCT01877421|P5|Participant Flow|6mg KSL-W|6mg KSL-W
122216|NCT01877421|P4|Participant Flow|4mg Placebo|4mg Placebo
122217|NCT01877421|P3|Participant Flow|4mg KSL-W|4mg KSL-W
122218|NCT01877421|P2|Participant Flow|2mg Placebo|2mg Placebo
122219|NCT01877421|P1|Participant Flow|2mg KSL-W|2mg KSL-W
122220|NCT01877421|O14|Outcome|Phase 2, 7b Placebo|Subjects from phase 2, 7b placebo group
122221|NCT01877421|O13|Outcome|Phase 2, 7b (75mg)|Subjects from phase 2, 7b (75mg) group
122222|NCT01877421|O12|Outcome|Phase 2, 6b Placebo|Subjects from phase 2, 6b placebo group
122223|NCT01877421|O11|Outcome|Phase 2, 6b (50mg)|Subjects from phase 2, 6b (50mg) group
122224|NCT01877421|O10|Outcome|Phase 2, 5b Placebo|Subjects from phase 2, 5b placebo group
122225|NCT01877421|O9|Outcome|Phase 2, 5b (30mg)|Subjects from phase 2, 5b (30mg) group
122226|NCT01877421|O8|Outcome|Phase 2, 4b Placebo|Subjects from phase 2, 4b placebo group
122227|NCT01877421|O7|Outcome|Phase 2, 4b (20mg)|Subjects from phase 2, 4b (20mg) group
122228|NCT01877421|O6|Outcome|Phase 2, 3b Placebo|Subjects from phase 2, 3b placebo group
122229|NCT01877421|O5|Outcome|Phase 2, 3b (10mg)|Subjects from phase 2, 3b (10mg) group
122230|NCT01877421|O4|Outcome|Phase 2, 2b Placebo|Subjects from phase 2, 2b placebo group
122231|NCT01877421|O3|Outcome|Phase 2, 2b (6mg)|Subjects from phase 2, 2b (6mg) group
122232|NCT01877421|O2|Outcome|Phase 2, 1b Placebo|Subjects from phase 2, 1b placebo
122233|NCT01877421|O1|Outcome|Phase 2, 1b (4mg)|Subjects from phase 2, 1b (4mg) group
122234|NCT01877421|O14|Outcome|Phase 2, 7b Placebo|Subjects from phase 2, 7b placebo group
122235|NCT01877421|O13|Outcome|Phase 2, 7b (75mg)|Subjects from phase 2, 7b (75mg) group
122236|NCT01877421|O12|Outcome|Phase 2, 6b Placebo|Subjects from phase 2, 6b placebo group
122237|NCT01877421|O11|Outcome|Phase 2, 6b (50mg)|Subjects from phase 2, 6b (50mg) group
122238|NCT01877421|O10|Outcome|Phase 2, 5b Placebo|Subjects from phase 2, 5b placebo group
122239|NCT01877421|O9|Outcome|Phase 2, 5b (30mg)|Subjects from phase 2, 5b (30mg) group
122240|NCT01877421|O8|Outcome|Phase 2, 4b Placebo|Subjects from phase 2, 4b placebo group
122241|NCT01877421|O7|Outcome|Phase 2, 4b (20mg)|Subjects from phase 2, 4b (20mg) group
122242|NCT01877421|O6|Outcome|Phase 2, 3b Placebo|Subjects from phase 2, 3b placebo group
122243|NCT01877421|O5|Outcome|Phase 2, 3b (10mg)|Subjects from phase 2, 3b (10mg) group
122244|NCT01877421|O4|Outcome|Phase 2, 2b Placebo|Subjects from phase 2, 2b placebo group
122245|NCT01877421|O3|Outcome|Phase 2, 2b (6mg)|Subjects from phase 2, 2b (6mg) group
122246|NCT01877421|O2|Outcome|Phase 2, 1b Placebo|Subjects from phase 2, 1b placebo
122247|NCT01877421|O1|Outcome|Phase 2, 1b (4mg)|Subjects from phase 2, 1b (4mg) group
122248|NCT01877421|O14|Outcome|Phase 2, 7b Placebo|Subjects from phase 2, 7b placebo group
122249|NCT01877421|O13|Outcome|Phase 2, 7b (75mg)|Subjects from phase 2, 7b (75mg) group
122250|NCT01877421|O12|Outcome|Phase 2, 6b Placebo|Subjects from phase 2, 6b placebo group
122251|NCT01877421|O11|Outcome|Phase 2, 6b (50mg)|Subjects from phase 2, 6b (50mg) group
122252|NCT01877421|O10|Outcome|Phase 2, 5b Placebo|Subjects from phase 2, 5b placebo group
122253|NCT01877421|O9|Outcome|Phase 2, 5b (30mg)|Subjects from phase 2, 5b (30mg) group
122254|NCT01877421|O8|Outcome|Phase 2, 4b Placebo|Subjects from phase 2, 4b placebo group
122255|NCT01877421|O7|Outcome|Phase 2, 4b (20mg)|Subjects from phase 2, 4b (20mg) group
122256|NCT01877421|O6|Outcome|Phase 2, 3b Placebo|Subjects from phase 2, 3b placebo group
122257|NCT01877421|O5|Outcome|Phase 2, 3b (10mg)|Subjects from phase 2, 3b (10mg) group
122258|NCT01877421|O4|Outcome|Phase 2, 2b Placebo|Subjects from phase 2, 2b placebo group
122259|NCT01877421|O3|Outcome|Phase 2, 2b (6mg)|Subjects from phase 2, 2b (6mg) group
122260|NCT01877421|O2|Outcome|Phase 2, 1b Placebo|Subjects from phase 2, 1b placebo
122261|NCT01877421|O1|Outcome|Phase 2, 1b (4mg)|Subjects from phase 2, 1b (4mg) group
122262|NCT01877421|O32|Outcome|Phase 2, 7b Placebo|Subjects from phase 2, 7b placebo group
122263|NCT01877421|O31|Outcome|Phase 2, 7b (75mg)|Subjects from phase 2, 7b (75mg) group
122264|NCT01877421|O30|Outcome|Phase 2, 6b Placebo|Subjects from phase 2, 6b placebo group
122265|NCT01877421|O29|Outcome|Phase 2, 6b (50mg)|Subjects from phase 2, 6b (50mg) group
122266|NCT01877421|O28|Outcome|Phase 2, 5b Placebo|Subjects from phase 2, 5b placebo group
122267|NCT01877421|O27|Outcome|Phase 2, 5b (30mg)|Subjects from phase 2, 5b (30mg) group
122268|NCT01877421|O26|Outcome|Phase 2, 4b Placebo|Subjects from phase 2, 4b placebo group
122269|NCT01877421|O25|Outcome|Phase 2, 4b (20mg)|Subjects from phase 2, 4b (20mg) group
122270|NCT01877421|O24|Outcome|Phase 2, 3b Placebo|Subjects from phase 2, 3b placebo group
122271|NCT01877421|O23|Outcome|Phase 2, 3b (10mg)|Subjects from phase 2, 3b (10mg) group
122272|NCT01877421|O22|Outcome|Phase 2, 2b Placebo|Subjects from phase 2, 2b placebo group
122273|NCT01877421|O21|Outcome|Phase 2, 2b (6mg)|Subjects from phase 2, 2b (6mg) group
122274|NCT01877421|O20|Outcome|Phase 2, 1b Placebo|Subjects from phase 2, 1b placebo
122275|NCT01877421|O19|Outcome|Phase 2, 1b (4mg)|Subjects from phase 2, 1b (4mg) group
122276|NCT01877421|O18|Outcome|Phase 1, 9a Placebo|Subjects from phase 1, 9a placebo group
122277|NCT01877421|O17|Outcome|Phase 1, 9a (100mg)|Subjects from phase 1, 9a (100mg) group
122278|NCT01877421|O16|Outcome|Phase 1, 8a Placebo|Subjects from phase 1, 8a placebo group
122279|NCT01877421|O15|Outcome|Phase 1, 8a (75mg)|Subjects from phase 1, 8a (75mg) group
122280|NCT01877421|O14|Outcome|Phase 1, 7a Placebo|Subjects from phase 1, 7a placebo group
122281|NCT01877421|O13|Outcome|Phase 1, 7a (50mg)|Subjects from phase 1, 7a (50mg) group
122282|NCT01877421|O12|Outcome|Phase 1, 6a Placebo|Subjects from phase 1, 6a placebo group
122283|NCT01877421|O11|Outcome|Phase 1, 6a (30mg)|Subjects from phase 1, 6a (30mg) group
122284|NCT01877421|O10|Outcome|Phase 1, 5a Placebo|Subjects from phase1, 5a placebo group
122285|NCT01877421|O9|Outcome|Phase 1, 5a (20mg)|Subjects from phase 1, 5a (20mg) group
122286|NCT01877421|O8|Outcome|Phase 1, 4a Placebo|Subjects from phase 1, 4a placebo group
122287|NCT01877421|O7|Outcome|Phase 1, 4a (10mg)|Subjects from phase 1, 4a (10mg) group
122288|NCT01877421|O6|Outcome|Phase 1, 3a Placebo|Subjects from phase 1, 3a placebo gorup
122289|NCT01877421|O5|Outcome|Phase 1, 3a (6mg)|Subject from phase 1, 3a (6mg) group
122290|NCT01877421|O4|Outcome|Phase 1, 2a Placebo|Subjects from phase 1, 2a (4mg) group
122291|NCT01877421|O3|Outcome|Phase 1, 2a (4mg)|Subjects from phase 1, 2a (4mg) group
122292|NCT01877421|O2|Outcome|Phase 1, 1a Placebo|Subjects from phase 1, 1a placebo group
122293|NCT01877421|O1|Outcome|Phase 1, 1a (2mg)|Subjects from phase 1, 1a (2mg) group
122294|NCT01877421|E32|Reported Event|Phase 2, 7b Placebo|Subjects from phase 2, 7b placebo group
122295|NCT01877421|E31|Reported Event|Phase 2, 7b (75mg)|Subjects from phase 2, 7b (75mg) group
122296|NCT01877421|E30|Reported Event|Phase 2, 6b Placebo|Subjects from phase 2, 6b placebo group
122297|NCT01877421|E29|Reported Event|Phase 2, 6b (50mg)|Subjects from phase 2, 6b (50mg) group
122298|NCT01877421|E28|Reported Event|Phase 2, 5b Placebo|Subjects from phase 2, 5b placebo group
122299|NCT01877421|E27|Reported Event|Phase 2, 5b (30mg)|Subjects from phase 2, 5b (30mg) group
122300|NCT01877421|E26|Reported Event|Phase 2, 4b Placebo|Subjects from phase 2, 4b placebo group
122301|NCT01877421|E25|Reported Event|Phase 2, 4b (20mg)|Subjects from phase 2, 4b (20mg) group
122302|NCT01877421|E24|Reported Event|Phase 2, 3b Placebo|Subjects from phase 2, 3b placebo group
122303|NCT01877421|E23|Reported Event|Phase 2, 3b (10mg)|Subjects from phase 2, 3b (10mg) group
122304|NCT01877421|E22|Reported Event|Phase 2, 2b Placebo|Subjects from phase 2, 2b placebo group
122305|NCT01877421|E21|Reported Event|Phase 2, 2b (6mg)|Subjects from phase 2, 2b (6mg) group
122306|NCT01877421|E20|Reported Event|Phase 2, 1b Placebo|Subjects from phase 2, 1b placebo
122307|NCT01877421|E19|Reported Event|Phase 2, 1b (4mg)|Subjects from phase 2, 1b (4mg) group
122308|NCT01877421|E18|Reported Event|Phase 1, 9a Placebo|Subjects from phase 1, 9a placebo group
122309|NCT01877421|E17|Reported Event|Phase 1, 9a (100mg)|Subjects from phase 1, 9a (100mg) group
122310|NCT01877421|E16|Reported Event|Phase 1, 8a Placebo|Subjects from phase 1, 8a placebo group
122311|NCT01877421|E15|Reported Event|Phase 1, 8a (75mg)|Subjects from phase 1, 8a (75mg) group
122312|NCT01877421|E14|Reported Event|Phase 1, 7a Placebo|Subjects from phase 1, 7a placebo group
122313|NCT01877421|E13|Reported Event|Phase 1, 7a (50mg)|Subjects from phase 1, 7a (50mg) group
122314|NCT01877421|E12|Reported Event|Phase 1, 6a Placebo|Subjects from phase 1, 6a placebo group
122315|NCT01877421|E11|Reported Event|Phase 1, 6a (30mg)|Subjects from phase 1, 6a (30mg) group
122316|NCT01877421|E10|Reported Event|Phase 1, 5a Placebo|Subjects from phase1, 5a placebo group
122317|NCT01877421|E9|Reported Event|Phase 1, 5a (20mg)|Subjects from phase 1, 5a (20mg) group
122318|NCT01877421|E8|Reported Event|Phase 1, 4a Placebo|Subjects from phase 1, 4a placebo group
122319|NCT01877421|E7|Reported Event|Phase 1, 4a (10mg)|Subjects from phase 1, 4a (10mg) group
122320|NCT01877421|E6|Reported Event|Phase 1, 3a Placebo|Subjects from phase 1, 3a placebo gorup
122321|NCT01877421|E5|Reported Event|Phase 1, 3a (6mg)|Subject from phase 1, 3a (6mg) group
122322|NCT01877421|E4|Reported Event|Phase 1, 2a Placebo|Subjects from phase 1, 2a (4mg) group
122323|NCT01877421|E3|Reported Event|Phase 1, 2a (4mg)|Subjects from phase 1, 2a (4mg) group
122324|NCT01877421|E2|Reported Event|Phase 1, 1a Placebo|Subjects from phase 1, 1a placebo group
122325|NCT01877421|E1|Reported Event|Phase 1, 1a (2mg)|Subjects from phase 1, 1a (2mg) group
122326|NCT01877408|B3|Baseline|Total|Total of all reporting groups
122327|NCT01877408|B2|Baseline|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
122328|NCT01877408|B1|Baseline|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
122329|NCT01877408|P2|Participant Flow|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
122330|NCT01877408|P1|Participant Flow|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
122331|NCT01877408|O2|Outcome|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
122332|NCT01877408|O1|Outcome|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
122333|NCT01877408|O2|Outcome|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
122334|NCT01877408|O1|Outcome|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
122335|NCT01877408|O2|Outcome|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
122336|NCT01877408|O1|Outcome|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
122337|NCT01877408|O2|Outcome|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
122338|NCT01877408|O1|Outcome|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
122339|NCT01877408|O2|Outcome|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
122340|NCT01877408|O1|Outcome|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
122341|NCT01877408|O1|Outcome|Physicians|The generalist doctors in this study were moderately experienced in open surgical circumcision but had not previously used the Unicirc instruments.
122342|NCT01877408|O2|Outcome|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
122343|NCT01877408|O1|Outcome|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
122344|NCT01877408|E2|Reported Event|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
122345|NCT01877408|E1|Reported Event|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
122346|NCT01877343|B4|Baseline|Total|Total of all reporting groups
122347|NCT01877343|B3|Baseline|Pediatric Controls|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
122348|NCT01877343|B2|Baseline|Pediatric Heart Transplant (1b)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
122349|NCT01877343|B1|Baseline|Adult Heart Transplant (1a)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
122350|NCT01877343|P7|Participant Flow|Adult Controls|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
122351|NCT01877343|P6|Participant Flow|Pediatric Controls|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
122352|NCT01877343|P5|Participant Flow|Pediatric Fontan|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
122353|NCT01877343|P4|Participant Flow|Adult Fontan|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
122354|NCT01877343|P3|Participant Flow|Adult Heart Failure|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
122355|NCT01877343|P2|Participant Flow|Pediatric Heart Tansplant (1b)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
122356|NCT01877343|P1|Participant Flow|Adult Heart Transplant (1a)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
122357|NCT01877343|O1|Outcome|CVInsight (TM)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
122358|NCT01877343|O1|Outcome|CVInsight (TM)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
122359|NCT01877343|E1|Reported Event|CVInsight (TM)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
122360|NCT01877278|B3|Baseline|Total|Total of all reporting groups
122361|NCT01877278|B2|Baseline|Placebo|"non emitting device~Wearable pulsed electromagnetic fields"
122362|NCT01877278|B1|Baseline|Active|"emitting group~Wearable pulsed electromagnetic fields"
122363|NCT01877278|P2|Participant Flow|Placebo|"non emitting device~Wearable pulsed electromagnetic fields"
122364|NCT01877278|P1|Participant Flow|Active|"emitting group~Wearable pulsed electromagnetic fields"
122365|NCT01877278|O2|Outcome|Placebo|"non emitting device~Wearable pulsed electromagnetic fields"
122366|NCT01877278|O1|Outcome|Active|"emitting group~Wearable pulsed electromagnetic fields"
122367|NCT01877278|O2|Outcome|Placebo|"non emitting device~Wearable pulsed electromagnetic fields"
122368|NCT01877278|O1|Outcome|Active|"emitting group~Wearable pulsed electromagnetic fields"
122369|NCT01877278|E2|Reported Event|Placebo|"non emitting device~Wearable pulsed electromagnetic fields"
122370|NCT01877278|E1|Reported Event|Active|"emitting group~Wearable pulsed electromagnetic fields"
122371|NCT01877161|B1|Baseline|rTMS Over MTG, STG, Sham|"3 sessions of Repetitive magnetic stimulation (rTMS) were applied to participants.~3 sessions of rTMS were determined by a random sequence (eg. MTG-STG-Sham, Sham-MTG-STG, STG-MTG-Sham etc.) MTG: middle temporal gyrus STG: superior temporal gyrus~The sequence of stimulation was counter-balanced across subjects. different sessions was performed after washout period (at least 3 days). The coil was placed perpendicularly to the scalp during sham rTMS sessions."
122372|NCT01877161|P1|Participant Flow|rTMS Over MTG, STG, Sham|"3 sessions of Repetitive magnetic stimulation (rTMS) were applied to participants 3 sessions of rTMS were determined by a random sequence (eg. middle temporal gyrus (MTG)-superior temporal gyrus (STG)-Sham, Sham-MTG-STG, STG-MTG-Sham etc..0) The sequence of stimulation was counter-balanced across subjects.~different sessions was performed after washout period (at least 3 days). The coil was placed perpendicularly to the scalp during sham rTMS sessions."
122373|NCT01877161|O3|Outcome|Sham rTMS|The coil was placed perpendicularly to the scalp during sham rTMS sessions.
122374|NCT01877161|O2|Outcome|rTMS Over STG|Repetitive magnetic stimulation (rTMS) were applied over STG
122375|NCT01877161|O1|Outcome|rTMS Over MTG|Repetitive magnetic stimulation (rTMS) were applied over MTG
122376|NCT01877161|E3|Reported Event|Superior Temporal Gyrus|"Repetitive magnetic stimulation to superior temporal gyrus~Repetitive magnetic stimulation to superior temporal gyrus: Repetitive magnetic stimulation to superior temporal gyrus"
122377|NCT01877161|E2|Reported Event|Control Group|"Repetitive magnetic stimulation (Sham)~Repetitive magnetic stimulation (Sham): Repetitive magnetic stimulation (Sham)"
122378|NCT01877161|E1|Reported Event|Middle Temporal Gyrus|"Repetitive magnetic stimulation to middle temporal gyrus~Repetitive magnetic stimulation to middle temporal gyrus: Repetitive magnetic stimulation to middle temporal gyrus"
122379|NCT01877148|B3|Baseline|Total|Total of all reporting groups
122405|NCT01876992|O2|Outcome|Obese Controls|"Three obese but otherwise healthy adult participants will be recruited into the study as controls. These will be individuals who are not currently (or previously) on any diabetic medication including metformin.~There will be a single study visit and no medication will be administered. They will be administered a meal and pre and post-prandial blood samples will be drawn."
123218|NCT01871402|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
122380|NCT01877148|B2|Baseline|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
122381|NCT01877148|B1|Baseline|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
122382|NCT01877148|P2|Participant Flow|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
122383|NCT01877148|P1|Participant Flow|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
122384|NCT01877148|O2|Outcome|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
122385|NCT01877148|O1|Outcome|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
122386|NCT01877148|O2|Outcome|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
122387|NCT01877148|O1|Outcome|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
122388|NCT01877148|O2|Outcome|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
122389|NCT01877148|O1|Outcome|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
122390|NCT01877148|O2|Outcome|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
122391|NCT01877148|O1|Outcome|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
122437|NCT01876810|O1|Outcome|Gemfibrozil|Participants taking Gemfibrozil: 600 mg of gemfibrozil (one capsule) twice daily for two weeks during the 1st phase of the study or during the second phase after the washout period.
122438|NCT01876810|O2|Outcome|Placebo|Participants taking Placebo (one capsule) twice daily for two weeks during the 1st phase of the study or during the second phase after a washout period.
122392|NCT01877148|E2|Reported Event|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
122393|NCT01877148|E1|Reported Event|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
122394|NCT01876992|B3|Baseline|Total|Total of all reporting groups
122395|NCT01876992|B2|Baseline|Obese Controls|"Three obese but otherwise healthy adult participants will be recruited into the study as controls. These will be individuals who are not currently (or previously) on any diabetic medication including metformin.~There will be a single study visit and no medication will be administered. They will be administered a meal and pre and post-prandial blood samples will be drawn."
122396|NCT01876992|B1|Baseline|Metformin|"Doses will be increased incrementally. Decisions to escalate the metformin dose will be made based upon tolerability of side effects as described in the schedule of evaluations to follow. All subjects will be monitored for safety while receiving metformin. Any participant with blood glucose of <60mg/dl at any time while receiving metformin will have therapy stopped and will be withdrawn from the study.~For children <50kg:~Baseline:250mg po qd, Week 2:250mg po bid, Week 4:500mg po am/250mg po pm~, Week 8:500mg po bid.~For children ≥50kg:~Baseline:500mg po qd, Week 2:500mg po bid, Week 4:1000mg po am/500mg po pm, Week 8:1000mg po bid.~For adults:~Baseline:500mg po qd,Week2:500mg po bid,Week 4:1000mg po am/500mg po pm,Week 8:1000mg po bid.~Metformin"
122397|NCT01876992|P2|Participant Flow|Obese Controls|"Three obese but otherwise healthy adult participants will be recruited into the study as controls. These will be individuals who are not currently (or previously) on any diabetic medication including metformin.~There will be a single study visit and no medication will be administered. They will be administered a meal and pre and post-prandial blood samples will be drawn."
122398|NCT01876992|P1|Participant Flow|Metformin|"Doses will be increased incrementally. Decisions to escalate the metformin dose will be made based upon tolerability of side effects as described in the schedule of evaluations to follow. All subjects will be monitored for safety while receiving metformin. Any participant with blood glucose of <60mg/dl at any time while receiving metformin will have therapy stopped and will be withdrawn from the study.~For children <50kg:~Baseline:250mg po qd, Week 2:250mg po bid, Week 4:500mg po am/250mg po pm, Week 8:500mg po bid.~For children ≥50kg:~Baseline:500mg po qd, Week 2:500mg po bid, Week 4:1000mg po am/500mg po pm, Week 8:1000mg po bid.~For adults:~Baseline:500mg po qd,Week2:500mg po bid,Week 4:1000mg po am/500mg po pm,Week 8:1000mg po bid.~Metformin"
122399|NCT01876992|O2|Outcome|Obese Controls|"Three obese but otherwise healthy adult participants will be recruited into the study as controls. These will be individuals who are not currently (or previously) on any diabetic medication including metformin.~There will be a single study visit and no medication will be administered. They will be administered a meal and pre and post-prandial blood samples will be drawn."
122400|NCT01876992|O1|Outcome|Metformin|"Doses will be increased incrementally. Decisions to escalate the metformin dose will be made based upon tolerability of side effects as described in the schedule of evaluations to follow. All subjects will be monitored for safety while receiving metformin. Any participant with blood glucose of <60mg/dl at any time while receiving metformin will have therapy stopped and will be withdrawn from the study.~For children <50kg:~Baseline:250mg po qd, Week 2:250mg po bid, Week 4:500mg po AM/250mg po PM, Week 8:500mg po bid.~For children ≥50kg:~Baseline:500mg po qd, Week 2:500mg po bid, Week 4:1000mg po AM/500mg po PM, Week 8:1000mg po bid.~For adults:~Baseline:500mg po qd,Week2:500mg po bid,Week 4:1000mg po AM/500mg po PM,Week 8:1000mg po bid.~Metformin"
122401|NCT01876992|O2|Outcome|Obese Controls|"Three obese but otherwise healthy adult participants will be recruited into the study as controls. These will be individuals who are not currently (or previously) on any diabetic medication including metformin.~There will be a single study visit and no medication will be administered. They will be administered a meal and pre and post-prandial blood samples will be drawn."
122402|NCT01876992|O1|Outcome|Metformin|"Doses will be increased incrementally. Decisions to escalate the metformin dose will be made based upon tolerability of side effects as described in the schedule of evaluations to follow. All subjects will be monitored for safety while receiving metformin. Any participant with blood glucose of <60mg/dl at any time while receiving metformin will have therapy stopped and will be withdrawn from the study.~For children <50kg:~Baseline:250mg po qd, Week 2:250mg po bid, Week 4:500mg po am/250mg po pm~, Week 8:500mg po bid.~For children ≥50kg:~Baseline:500mg po qd, Week 2:500mg po bid, Week 4:1000mg po am/500mg po pm, Week 8:1000mg po bid.~For adults:~Baseline:500mg po qd,Week2:500mg po bid,Week 4:1000mg po am/500mg po pm,Week 8:1000mg po bid.~Metformin"
122403|NCT01876992|O2|Outcome|Obese Controls|"Three obese but otherwise healthy adult participants will be recruited into the study as controls. These will be individuals who are not currently (or previously) on any diabetic medication including metformin.~There will be a single study visit and no medication will be administered. They will be administered a meal and pre and post-prandial blood samples will be drawn."
122404|NCT01876992|O1|Outcome|Metformin|"Doses will be increased incrementally. Decisions to escalate the metformin dose will be made based upon tolerability of side effects as described in the schedule of evaluations to follow. All subjects will be monitored for safety while receiving metformin. Any participant with blood glucose of <60mg/dl at any time while receiving metformin will have therapy stopped and will be withdrawn from the study.~For children <50kg:~Baseline:250mg po qd, Week 2:250mg po bid, Week 4:500mg po am/250mg po pm~, Week 8:500mg po bid.~For children ≥50kg:~Baseline:500mg po qd, Week 2:500mg po bid, Week 4:1000mg po am/500mg po pm, Week 8:1000mg po bid.~For adults:~Baseline:500mg po qd,Week2:500mg po bid,Week 4:1000mg po am/500mg po pm,Week 8:1000mg po bid.~Metformin"
122439|NCT01876810|O1|Outcome|Gemfibrozil|Participants taking Gemfibrozil: 600 mg of gemfibrozil (one capsule) twice daily for two weeks during the 1st phase of the study or during the second phase after a washout period .
122406|NCT01876992|O1|Outcome|Metformin|"Doses will be increased incrementally. Decisions to escalate the metformin dose will be made based upon tolerability of side effects as described in the schedule of evaluations to follow. All subjects will be monitored for safety while receiving metformin. Any participant with blood glucose of <60mg/dl at any time while receiving metformin will have therapy stopped and will be withdrawn from the study.~For children <50kg:~Baseline:250mg po qd, Week 2:250mg po bid, Week 4:500mg po AM/250mg po PM, Week 8:500mg po bid.~For children ≥50kg:~Baseline:500mg po qd, Week 2:500mg po bid, Week 4:1000mg po AM/500mg po PM, Week 8:1000mg po bid.~For adults:~Baseline:500mg po qd,Week2:500mg po bid,Week 4:1000mg po AM/500mg po PM,Week 8:1000mg po bid.~Metformin"
122407|NCT01876992|E2|Reported Event|Obese Controls|"Three obese but otherwise healthy adult participants will be recruited into the study as controls. These will be individuals who are not currently (or previously) on any diabetic medication including metformin.~There will be a single study visit and no medication will be administered. They will be administered a meal and pre and post-prandial blood samples will be drawn."
122408|NCT01876992|E1|Reported Event|Metformin|"Doses will be increased incrementally. Decisions to escalate the metformin dose will be made based upon tolerability of side effects as described in the schedule of evaluations to follow. All subjects will be monitored for safety while receiving metformin. Any participant with blood glucose of <60mg/dl at any time while receiving metformin will have therapy stopped and will be withdrawn from the study.~For children <50kg:~Baseline:250mg po qd, Week 2:250mg po bid, Week 4:500mg po AM/250mg po PM, Week 8:500mg po bid.~For children ≥50kg:~Baseline:500mg po qd, Week 2:500mg po bid, Week 4:1000mg po AM/500mg po PM, Week 8:1000mg po bid.~For adults:~Baseline:500mg po qd,Week2:500mg po bid,Week 4:1000mg po AM/500mg po PM,Week 8:1000mg po bid.~Metformin"
122409|NCT01876979|B3|Baseline|Total|Total of all reporting groups
122410|NCT01876979|B2|Baseline|Erich Arch Bars|"Use of Erich Arch bars in the wiring of the jaws.~Erich Arch Bars: Surgical braces wired around teeth"
122411|NCT01876979|B1|Baseline|Intermaxillary Fixation Screws|"Use of Intermaxillary Fixation screws as a means to wire the jaws.~IMF Screws: stainless steel screws placed in bone"
122412|NCT01876979|P2|Participant Flow|Erich Arch Bars|"Use of Erich Arch bars in the wiring of the jaws.~Erich Arch Bars: Surgical braces wired around teeth"
122413|NCT01876979|P1|Participant Flow|IMF Screws|"Use of IMF screws as a means to wire the jaws.~IMF Screws: stainless steel screws placed in bone"
122414|NCT01876979|O2|Outcome|Erich Arch Bars|"Use of Erich Arch bars in the wiring of the jaws.~Erich Arch Bars: Surgical braces wired around teeth"
122415|NCT01876979|O1|Outcome|IMF Screws|"Use of IMF screws as a means to wire the jaws.~IMF Screws: stainless steel screws placed in bone"
122416|NCT01876979|E2|Reported Event|Erich Arch Bars|"Use of Erich Arch bars in the wiring of the jaws.~Erich Arch Bars: Surgical braces wired around teeth"
122417|NCT01876979|E1|Reported Event|IMF Screws|"Use of IMF screws as a means to wire the jaws.~IMF Screws: stainless steel screws placed in bone"
122418|NCT01876823|B1|Baseline|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
122419|NCT01876823|P1|Participant Flow|Es-citalopram and Memantine Treatment|This group received concurrent es-citalopram plus memantine treatment for 48 weeks. Patients ranged in age from 50-90 years old. Es-citalopram treatment began at 10mg per day for two weeks and was increased to 20mg per day for the 48 week duration. If a patient had an inadequate response to the antidepressant on two consecutive visits, the study physician used an alternative. At two weeks into the study, the patients were started on memantine 5mg, and the maximum dose of 20mg was reached by the six week point.
122420|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
122421|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
122422|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
122423|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
122424|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
122425|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
122426|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
122427|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
122428|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
122429|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
122430|NCT01876823|E1|Reported Event|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
122431|NCT01876810|B1|Baseline|All Study Participants|"600 mg of gemfibrozil (one capsule) twice daily for two weeks.~Gemfibrozil: 600 mg of gemfibrozil (one capsule) twice daily for two weeks. or One lactose pill twice a day for two weeks."
122432|NCT01876810|P2|Participant Flow|Placebo/Gemfibrozil|Participants received 1 capsule of placebo for 2 weeks. Then a washout period of 1 week of no medication. Then they received 600 mg of gemfibrozil (one capsule) twice daily for two weeks.
122433|NCT01876810|P1|Participant Flow|Gemfibrozil/Placebo|Participants received 600 mg of gemfibrozil (one capsule) twice daily for two weeks. Then a washout period of 1 week of no medication. Then they received 1 capsule of placebo twice daily for 2 weeks
122434|NCT01876810|O2|Outcome|Placebo Group|Participants taking Placebo (one capsule) twice daily for two weeks during the 1st phase of the study or during the second phase after the washout period.
122435|NCT01876810|O1|Outcome|Gemfibrozil|Participants taking Gemfibrozil 600 mg (one capsule twice daily) for two weeks during the 1st phase of the study or during the second phase after the washout period.
122436|NCT01876810|O2|Outcome|Placebo Group|Participants taking Placebo (one capsule) twice daily for two weeks during the 1st phase of the study or during the second phase after the washout period.
122475|NCT01876368|B1|Baseline|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
122440|NCT01876810|E2|Reported Event|Placebo/Gemfibrozil|"One lactose pill twice a day for two weeks.~Participants taking Placebo (one capsule) twice daily for two weeks during the 1st phase of the study followed by a the washout period. Then they received 1 capsule of gemfibrozil twice daily for 2 weeks"
122441|NCT01876810|E1|Reported Event|Gemfibrozil/Placebo|"600 mg of gemfibrozil (one capsule) twice daily for two weeks.~Participants taking Gemfibrozil: 600 mg of gemfibrozil (one capsule) twice daily for two weeks during the 1st phase of the study followed by a the washout period. Then they received 1 capsule of placebo twice daily for 2 weeks"
122442|NCT01876784|B3|Baseline|Total|Total of all reporting groups
122443|NCT01876784|B2|Baseline|Placebo|Placebo matched to vandetanib tablet, orally once daily until disease progression or death.
122444|NCT01876784|B1|Baseline|Vandetanib|Vandetanib 300 mg tablet, orally once daily until disease progression or death.
122445|NCT01876784|P2|Participant Flow|Placebo|Placebo matched to vandetanib tablet, orally once daily until disease progression or death.
122446|NCT01876784|P1|Participant Flow|Vandetanib|Vandetanib 300 mg tablet, orally once daily until disease progression or death.
122447|NCT01876784|O2|Outcome|Placebo|Placebo matched to vandetanib tablet, orally once daily until disease progression or death.
122448|NCT01876784|O1|Outcome|Vandetanib|Vandetanib 300 mg tablet, orally once daily until disease progression or death.
122449|NCT01876784|E2|Reported Event|Placebo|Placebo matched to vandetanib tablet, orally once daily until disease progression or death.
122450|NCT01876784|E1|Reported Event|Vandetanib|Vandetanib 300 mg tablet, orally once daily until disease progression or death.
122451|NCT01876732|B1|Baseline|Vitamin B12|Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.
122452|NCT01876732|P1|Participant Flow|Vitamin B12|"Those with an methylmalonic acid (MMA) over 800nmol/L are given 1000mcg of intramuscular (IM) vitamin B12 weekly for the first month and then monthly for 3 consecutive months.~Vitamin B 12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first hemodialysis (HD) session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a Kidney Disease Quality of Life- 36 (KDQOL-36) prior to therapy and again post treatment."
122453|NCT01876732|O1|Outcome|Vitamin B12|"Those with an methylmalonic acid (MMA) over 800nmol/L are given 1000mcg of intramuscular (IM) vitamin B12 weekly for the first month and then monthly for 3 consecutive months.~Vitamin B 12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first hemodialysis (HD) session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a Kidney Disease Quality of Life- 36 (KDQOL-36) prior to therapy and again post treatment."
122454|NCT01876732|O1|Outcome|Vitamin B12|"Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.~Vitamin B12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first HD session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a KDQOL-36 prior to therapy and again post treatment."
122455|NCT01876732|E1|Reported Event|Vitamin B12|"Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.~Vitamin B12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first HD session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a KDQOL-36 prior to therapy and again post treatment."
122456|NCT01876706|B1|Baseline|UroLift Arm|Subjects that undergo the UroLift System procedure
122457|NCT01876706|P1|Participant Flow|UroLift Arm|Subjects that undergo the UroLift System procedure
122458|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
122459|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
122460|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
122461|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
122462|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
122463|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
122464|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
122465|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
122466|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
122467|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
122468|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
122469|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
122470|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
122471|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
122472|NCT01876706|E1|Reported Event|UroLift Arm|Subjects that undergo the UroLift System procedure
122473|NCT01876368|B3|Baseline|Total|Total of all reporting groups
122474|NCT01876368|B2|Baseline|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
138935|NCT01791725|E2|Reported Event|ELND005 QD|"ELND005 250 mg QD~ELND005"
122476|NCT01876368|P2|Participant Flow|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
122477|NCT01876368|P1|Participant Flow|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
122478|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
122479|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
122480|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
122481|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
122482|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
122483|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
122484|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
122485|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
122486|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
122487|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
122488|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
122489|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
122490|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
122491|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
122492|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
122493|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
122494|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
122495|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
122496|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
122497|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
122498|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
122499|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
122500|NCT01876368|E2|Reported Event|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
122501|NCT01876368|E1|Reported Event|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
122502|NCT01876329|B4|Baseline|Total|Total of all reporting groups
122503|NCT01876329|B3|Baseline|Control|Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
122504|NCT01876329|B2|Baseline|Autoimmune Thyroid Disease (AITD)|Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.
122505|NCT01876329|B1|Baseline|Rheumatoid Arthritis|Patients with seropositive or seronegative Rheumatoid Arthritis
122506|NCT01876329|P3|Participant Flow|Control|Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
122507|NCT01876329|P2|Participant Flow|Autoimmune Thyroid Disease (AITD)|Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.
122508|NCT01876329|P1|Participant Flow|Rheumatoid Arthritis|Patients with seropositive or seronegative Rheumatoid Arthritis
122509|NCT01876329|O3|Outcome|Control|Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
122510|NCT01876329|O2|Outcome|Autoimmune Thyroid Disease (AITD)|Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.
122511|NCT01876329|O1|Outcome|Rheumatoid Arthritis|Patients with seropositive or seronegative Rheumatoid Arthritis
122512|NCT01876329|O3|Outcome|Control|Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
122513|NCT01876329|O2|Outcome|Autoimmune Thyroid Disease (AITD)|Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.
122514|NCT01876329|O1|Outcome|Rheumatoid Arthritis|Patients with seropositive or seronegative Rheumatoid Arthritis
122515|NCT01876329|E3|Reported Event|Control|Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
122516|NCT01876329|E2|Reported Event|Autoimmune Thyroid Disease (AITD)|Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.
122517|NCT01876329|E1|Reported Event|Rheumatoid Arthritis|Patients with seropositive or seronegative Rheumatoid Arthritis
122518|NCT01875991|B3|Baseline|Total|Total of all reporting groups
122674|NCT01874665|O1|Outcome|Cohort A|Participants with KIT exon 11-mutant GIST ponatinib: 45 mg, taken orally once-daily.
122519|NCT01875991|B2|Baseline|Autoinjector B / Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks, and then switched over to Autoinjector A for an additional 4 weeks of treatment.
122520|NCT01875991|B1|Baseline|Autoinjector A / Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks, and then switched over to Autoinjector B for an additional 4 weeks of treatment.
122521|NCT01875991|P2|Participant Flow|Autoinjector B / Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks, and then switched over to Autoinjector A for an additional 4 weeks of treatment.
122522|NCT01875991|P1|Participant Flow|Autoinjector A / Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks, and then switched over to Autoinjector B for an additional 4 weeks of treatment.
122523|NCT01875991|O2|Outcome|Autoinjector B Preference|Participants who preferred Autoinjector B overall
122524|NCT01875991|O1|Outcome|Autoinjector A Preference|Participants who preferred Autoinjector A overall
122525|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
122526|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
122527|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
122528|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
122529|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
122530|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
122531|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
122532|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
122533|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
122534|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
122535|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
122536|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
122537|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
122538|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
122539|NCT01875991|O1|Outcome|Primary Analysis Set|Participants who received at least one injection with each autoinjector and completed the Subject Preference Questionnaire.
122540|NCT01875991|E2|Reported Event|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
122541|NCT01875991|E1|Reported Event|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
122542|NCT01875978|B3|Baseline|Total|Total of all reporting groups
122543|NCT01875978|B2|Baseline|Group B:Placebo-phytosterols|Placebo for 4 weeks, washout 2 weeks, then daily 1.8g phytosterols powder for 4 weeks
122544|NCT01875978|B1|Baseline|Group A:Phytosterols-placebo|Daily 1.8g phytosterols powder for 4 weeks, washout 2weeks, then placebo for 4 weeks
122545|NCT01875978|P2|Participant Flow|Group B:Placebo-phytosterols|Placebo first, then phytosterols 1.8g/day
122546|NCT01875978|P1|Participant Flow|Group A:Phytosterols-placebo|phytosterols 1.8g/day first, then placebo.
122547|NCT01875978|O2|Outcome|Group B:Placebo-phytosterols|Placebo first, then phytosterols 1.8g/day
122548|NCT01875978|O1|Outcome|Group A:Phytosterols-placebo|phytosterols 1.8g/day first, then placebo.
122549|NCT01875978|O2|Outcome|Group B:Placebo-phytosterols|Placebo first, then phytosterols 1.8g/day
122550|NCT01875978|O1|Outcome|Group A:Phytosterols-placebo|phytosterols 1.8g/day first, then placebo.
122551|NCT01875978|O2|Outcome|Group B:Placebo-phytosterols|Placebo first, then phytosterols 1.8g/day
122552|NCT01875978|O1|Outcome|Group A:Phytosterols-placebo|phytosterols 1.8g/day first, then placebo.
122553|NCT01875978|O2|Outcome|Group B:Placebo-phytosterols|Placebo for 4 weeks, washout 2 weeks, then daily 1.8g phytosterols powder for 4 weeks
122554|NCT01875978|O1|Outcome|Group A:Phytosterols-placebo|Daily 1.8g phytosterols powder for 4 weeks, washout 2weeks, then placebo for 4 weeks
122555|NCT01875978|E2|Reported Event|Group B: Placebo-phytosterols|placebo for 4 weeks, washout 2 weeks. then daily 1.8 g phytosterols for 4 weeks
122556|NCT01875978|E1|Reported Event|Group A: Phytosterols-placebo|Daily 1.8g phytosterols powder for 4 weeks, washout 2 weeks, then placebo for 4 weeks
122557|NCT01875848|B3|Baseline|Total|Total of all reporting groups
122558|NCT01875848|B2|Baseline|Opioid Dose Escalation|"increase of up to 25% of current opioid dose~opioid dose escalation: up to 25% increase in patient's current opioid dose"
122559|NCT01875848|B1|Baseline|Buprenorphine/Naloxone|"induction onto buprenorphine/naloxone from opioid treatment~buprenorphine/naloxone: partial opioid agonist"
122560|NCT01875848|P2|Participant Flow|Opioid Dose Escalation|"increase of up to 25% of current opioid dose~opioid dose escalation: up to 25% increase in patient's current opioid dose"
122561|NCT01875848|P1|Participant Flow|Buprenorphine/Naloxone|"induction onto buprenorphine/naloxone from opioid treatment~buprenorphine/naloxone: partial opioid agonist"
122562|NCT01875848|O2|Outcome|Opioid Dose Escalation|"increase of up to 25% of current opioid dose~opioid dose escalation: up to 25% increase in patient's current opioid dose"
122563|NCT01875848|O1|Outcome|Buprenorphine/Naloxone|"induction onto buprenorphine/naloxone from opioid treatment~buprenorphine/naloxone: partial opioid agonist"
122564|NCT01875848|O2|Outcome|Opioid Dose Escalation|"increase of up to 25% of current opioid dose~opioid dose escalation: up to 25% increase in patient's current opioid dose"
122565|NCT01875848|O1|Outcome|Buprenorphine/Naloxone|"induction onto buprenorphine/naloxone from opioid treatment~buprenorphine/naloxone: partial opioid agonist"
122566|NCT01875848|E2|Reported Event|Opioid Dose Escalation|"increase of up to 25% of current opioid dose~opioid dose escalation: up to 25% increase in patient's current opioid dose"
122567|NCT01875848|E1|Reported Event|Buprenorphine/Naloxone|"induction onto buprenorphine/naloxone from opioid treatment~buprenorphine/naloxone: partial opioid agonist"
122568|NCT01875783|B1|Baseline|OCT Imaging|"All study participants will undergo optical coherence tomography imaging and will be referred to a retina specialist for further standard care evaluation and management if they are identified as having diabetic macular edema or the scan quality is not sufficient to evaluate macular status.~OCT imaging: Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina."
122569|NCT01875783|P1|Participant Flow|OCT Imaging|"All study participants will undergo optical coherence tomography imaging and will be referred to a retina specialist for further standard care evaluation and management if they are identified as having diabetic macular edema or the scan quality is not sufficient to evaluate macular status.~OCT imaging: Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina."
122570|NCT01875783|O1|Outcome|Participants Referred for Retina Care|Study participants identified for retina referral by the OCT guided referral algorithm.
122571|NCT01875783|O1|Outcome|Participants Referred for Retina Care|Study participants identified for retina referral by the OCT guided referral algorithm.
122572|NCT01875783|O1|Outcome|Eyes That Have Undergone OCT Imaging|"All study participants will undergo optical coherence tomography imaging and will be referred to a retina specialist for further standard care evaluation and management if they are identified as having diabetic macular edema or the scan quality is not sufficient to evaluate macular status.~OCT imaging: Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina."
122573|NCT01875783|O1|Outcome|Retina Specialist Care|Percentage of participants who follow-up with a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm as compared with the percentage of patients currently receiving retina eye care (assessed by study participant self-report as well as by determination of historical retina eye care rates from documentation in the medical records of study-eligible patients seen within the previous 6 months)
122574|NCT01875783|E1|Reported Event|OCT Imaging|"All study participants will undergo optical coherence tomography imaging and will be referred to a retina specialist for further standard care evaluation and management if they are identified as having diabetic macular edema or the scan quality is not sufficient to evaluate macular status.~OCT imaging: Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina."
122575|NCT01875731|B3|Baseline|Total|Total of all reporting groups
122576|NCT01875731|B2|Baseline|Guideline|"Strategy based on enforced guideline guided antibiotic use~Guideline: Strategy based on enforced guideline guided antibiotic use"
122577|NCT01875731|B1|Baseline|BPS (Bacterial Pneumonia Score)|"Strategy based on BPS guided antibiotic use~BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline."
122578|NCT01875731|P2|Participant Flow|Guideline|"Strategy based on enforced guideline guided antibiotic use~Guideline: Strategy based on enforced guideline guided antibiotic use"
122579|NCT01875731|P1|Participant Flow|BPS (Bacterial Pneumonia Score)|"Strategy based on BPS guided antibiotic use~BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline."
122580|NCT01875731|O2|Outcome|Guideline|"Strategy based on enforced guideline guided antibiotic use~Guideline: Strategy based on enforced guideline guided antibiotic use"
122581|NCT01875731|O1|Outcome|BPS (Bacterial Pneumonia Score)|"Strategy based on BPS guided antibiotic use~BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline."
122582|NCT01875731|O2|Outcome|Guideline|"Strategy based on enforced guideline guided antibiotic use~Guideline: Strategy based on enforced guideline guided antibiotic use"
122583|NCT01875731|O1|Outcome|BPS (Bacterial Pneumonia Score)|"Strategy based on BPS guided antibiotic use~BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline."
122584|NCT01875731|E2|Reported Event|Guideline|"Strategy based on enforced guideline guided antibiotic use~Guideline: Strategy based on enforced guideline guided antibiotic use"
122585|NCT01875731|E1|Reported Event|BPS (Bacterial Pneumonia Score)|"Strategy based on BPS guided antibiotic use~BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline."
122586|NCT01875510|B3|Baseline|Total|Total of all reporting groups
122587|NCT01875510|B2|Baseline|Soybean-oil Emulsion|Preterm infants will receive a soybean-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and the third day and after 3gr/kg
122588|NCT01875510|B1|Baseline|Fish-oil Emulsions|Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg.
122589|NCT01875510|P2|Participant Flow|Soybean-oil Emulsion|Preterm infants will receive a soybean-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and the third day and after 3gr/kg
122590|NCT01875510|P1|Participant Flow|Fish-oil Emulsions|Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg.
122591|NCT01875510|O2|Outcome|Soybean-oil Emulsion|Preterm infants will receive a soybean-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and the third day and after 3gr/kg
122592|NCT01875510|O1|Outcome|Fish-oil Emulsions|Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg.
122762|NCT01874275|O1|Outcome|VECTTOR|nerve stimulator treatment twice daily for duration of study
122593|NCT01875510|E2|Reported Event|Soybean-oil Emulsion|Preterm infants will receive a soybean-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and the third day and after 3gr/kg
122594|NCT01875510|E1|Reported Event|Fish-oil Emulsions|Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg.
122595|NCT01875471|B3|Baseline|Total|Total of all reporting groups
122596|NCT01875471|B2|Baseline|Narafilcon A|"Spherical daily disposable soft contact lens Class 1 UV blocking~narafilcon A: Daily disposable contact lens to be worn at least 8 hours daily"
122597|NCT01875471|B1|Baseline|Delefilcon A|"Spherical daily disposable soft contact lens~delefilcon A: Daily disposable soft contact lens to be worn at least 8 hours daily"
122598|NCT01875471|P2|Participant Flow|Narafilcon A|Spherical daily disposable soft contact lens with UV blocking
122599|NCT01875471|P1|Participant Flow|Delefilcon A|Spherical daily disposable soft contact lens
122600|NCT01875471|O2|Outcome|Narafilcon A|Spherical daily disposable soft contact lens with UV blocking
122601|NCT01875471|O1|Outcome|Delefilcon A|Spherical daily disposable soft contact lens
122602|NCT01875471|E2|Reported Event|Narafilcon A|"Spherical daily disposable soft contact lens Class 1 UV blocking~narafilcon A: Daily disposable contact lens to be worn at least 8 hours daily"
122603|NCT01875471|E1|Reported Event|Delefilcon A|"Spherical daily disposable soft contact lens~delefilcon A: Daily disposable soft contact lens to be worn at least 8 hours daily"
122604|NCT01875445|B3|Baseline|Total|Total of all reporting groups
122605|NCT01875445|B2|Baseline|Inositol|"Powder form, 2g TID up to 6g TID~Inositol: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
122606|NCT01875445|B1|Baseline|Placebo|"Matched dosage of inositol daily.~Placebo: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
122607|NCT01875445|P2|Participant Flow|Inositol|"Powder form, 2g TID up to 6g TID~Inositol: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
122608|NCT01875445|P1|Participant Flow|Placebo|"Matched dosage of inositol daily.~Placebo: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
122609|NCT01875445|O2|Outcome|Inositol|"Powder form, 2g TID up to 6g TID~Inositol: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
122610|NCT01875445|O1|Outcome|Placebo|"Matched dosage of inositol daily.~Placebo: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
122611|NCT01875445|O2|Outcome|Inositol|"Powder form, 2g TID up to 6g TID~Inositol: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
122612|NCT01875445|O1|Outcome|Placebo|"Matched dosage of inositol daily.~Placebo: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
122613|NCT01875445|E2|Reported Event|Inositol|"Powder form, 2g TID up to 6g TID~Inositol: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
122614|NCT01875445|E1|Reported Event|Placebo|"Matched dosage of inositol daily.~Placebo: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
122615|NCT01875185|B3|Baseline|Total|Total of all reporting groups
122616|NCT01875185|B2|Baseline|Postmenopausal|Aspirin 81 mg PO daily x 7 days
122617|NCT01875185|B1|Baseline|Premenopausal|Aspirin 81 mg PO daily x 7 days
122618|NCT01875185|P2|Participant Flow|Postmenopausal|Aspirin 81 mg PO daily x 7 days
122619|NCT01875185|P1|Participant Flow|Premenopausal|Aspirin 81 mg PO daily x 7 days
122620|NCT01875185|O2|Outcome|Postmenopausal|Postmenopausal females in the cohort Aspirin 81 mg PO daily x 7 days
122621|NCT01875185|O1|Outcome|Premenopausal|Premenopausal females in the cohort Aspirin 81 mg PO daily x 7 days
122622|NCT01875185|O2|Outcome|Postmenopausal|Postmenopausal females in the cohort Aspirin 81 mg PO daily x 7 days
122623|NCT01875185|O1|Outcome|Premenopausal|Premenopausal females in the cohort Aspirin 81 mg PO daily x 7 days
122624|NCT01875185|O2|Outcome|Postmenopausal|Aspirin 81 mg PO daily x 7 days
122625|NCT01875185|O1|Outcome|Premenopausal|Aspirin 81 mg PO daily x 7 days
122626|NCT01875185|O2|Outcome|Postmenopausal|Postmenopausal Women in the cohort
122627|NCT01875185|O1|Outcome|Premenopausal|premenopausal Women in the cohort
122628|NCT01875185|E2|Reported Event|Postmenopausal|Aspirin 81 mg PO daily x 7 days
122629|NCT01875185|E1|Reported Event|Premenopausal|Aspirin 81 mg PO daily x 7 days
122630|NCT01875159|B3|Baseline|Total|Total of all reporting groups
122631|NCT01875159|B2|Baseline|Active Comparator: no Caffeine|Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
122632|NCT01875159|B1|Baseline|Caffeine|"Caffeine citrate 6 mg/kg/day~Caffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age."
122633|NCT01875159|P2|Participant Flow|Active Comparator: no Caffeine|Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
122634|NCT01875159|P1|Participant Flow|Caffeine|"Caffeine citrate 6 mg/kg/day~Caffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age."
122635|NCT01875159|O2|Outcome|Active Comparator: no Caffeine|Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
122636|NCT01875159|O1|Outcome|Caffeine|"Caffeine citrate 6 mg/kg/day~Caffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age."
122637|NCT01875159|O2|Outcome|Active Comparator: no Caffeine|Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
122638|NCT01875159|O1|Outcome|Caffeine|"Caffeine citrate 6 mg/kg/day~Caffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age."
122639|NCT01875159|E2|Reported Event|Active Comparator: no Caffeine|Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
122640|NCT01875159|E1|Reported Event|Caffeine|"Caffeine citrate 6 mg/kg/day~Caffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age."
122641|NCT01874951|B3|Baseline|Total|Total of all reporting groups
122642|NCT01874951|B2|Baseline|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
122643|NCT01874951|B1|Baseline|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
122644|NCT01874951|P2|Participant Flow|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
122645|NCT01874951|P1|Participant Flow|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
122646|NCT01874951|O2|Outcome|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
122647|NCT01874951|O1|Outcome|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
122648|NCT01874951|O2|Outcome|Naltrexone|In this arm, patients will receive low dose naltrexone for three weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
122649|NCT01874951|O1|Outcome|Placebo|"In this arm, patients will receive placebo for three weeks.~Placebo: Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo."
122650|NCT01874951|O2|Outcome|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks.1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
122651|NCT01874951|O1|Outcome|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
122652|NCT01874951|O2|Outcome|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
122653|NCT01874951|O1|Outcome|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
122654|NCT01874951|O2|Outcome|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
122655|NCT01874951|O1|Outcome|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
122656|NCT01874951|O2|Outcome|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
122657|NCT01874951|O1|Outcome|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
122658|NCT01874951|O2|Outcome|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
122659|NCT01874951|O1|Outcome|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
122660|NCT01874951|O2|Outcome|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
122661|NCT01874951|O1|Outcome|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
122662|NCT01874951|E2|Reported Event|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
122663|NCT01874951|E1|Reported Event|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
122664|NCT01874665|B3|Baseline|Total|Total of all reporting groups
122665|NCT01874665|B2|Baseline|Cohort B|Participants with GIST that lack KIT exon 11 mutations (Cohort B) ponatinib: 45 mg, taken orally once-daily.
122666|NCT01874665|B1|Baseline|Cohort A|Participants with KIT exon 11-mutant GIST ponatinib: 45 mg, taken orally once-daily.
122667|NCT01874665|P2|Participant Flow|Cohort B|Participants with gastrointestinal stromal tumors (GIST) that lack KIT exon 11 mutations (Cohort B) ponatinib: 45 mg, taken orally once-daily.
122668|NCT01874665|P1|Participant Flow|Cohort A|Participants with KIT exon 11-mutant GIST ponatinib: 45 milligram (mg), taken orally once-daily.
122669|NCT01874665|O2|Outcome|Cohort B|Participants with GIST that lack KIT exon 11 mutations (Cohort B) ponatinib: 45 mg, taken orally once-daily.
122670|NCT01874665|O1|Outcome|Cohort A|Participants with KIT exon 11-mutant GIST ponatinib: 45 mg, taken orally once-daily.
122671|NCT01874665|O2|Outcome|Cohort B|Participants with GIST that lack KIT exon 11 mutations (Cohort B) ponatinib: 45 mg, taken orally once-daily.
122672|NCT01874665|O1|Outcome|Cohort A|Participants with KIT exon 11-mutant GIST ponatinib: 45 mg, taken orally once-daily.
122673|NCT01874665|O2|Outcome|Cohort B|Participants with GIST that lack KIT exon 11 mutations (Cohort B) ponatinib: 45 mg, taken orally once-daily.
122675|NCT01874665|O2|Outcome|Cohort B|Participants with GIST that lack KIT exon 11 mutations (Cohort B) ponatinib: 45 mg, taken orally once-daily.
122676|NCT01874665|O1|Outcome|Cohort A|Participants with KIT exon 11-mutant GIST ponatinib: 45 mg, taken orally once-daily.
122677|NCT01874665|O2|Outcome|Cohort B|Participants with GIST that lack KIT exon 11 mutations (Cohort B) ponatinib: 45 mg, taken orally once-daily.
122678|NCT01874665|O1|Outcome|Cohort A|Participants with KIT exon 11-mutant GIST ponatinib: 45 mg, taken orally once-daily.
122679|NCT01874665|O2|Outcome|Cohort B|Participants with GIST that lack KIT exon 11 mutations (Cohort B) ponatinib: 45 mg, taken orally once-daily.
122680|NCT01874665|O1|Outcome|Cohort A|Participants with KIT exon 11-mutant GIST ponatinib: 45 mg, taken orally once-daily.
122681|NCT01874665|O2|Outcome|Cohort B|Participants with GIST that lack KIT exon 11 mutations (Cohort B) ponatinib: 45 mg, taken orally once-daily.
122682|NCT01874665|O1|Outcome|Cohort A|Participants with KIT exon 11-mutant GIST ponatinib: 45 mg, taken orally once-daily.
122683|NCT01874665|O2|Outcome|Cohort B|Participants with GIST that lack KIT exon 11 mutations (Cohort B) ponatinib: 45 mg, taken orally once-daily.
122684|NCT01874665|O1|Outcome|Cohort A|Participants with KIT exon 11-mutant GIST ponatinib: 45 mg, taken orally once-daily.
122685|NCT01874665|O2|Outcome|Cohort B|Participants with GIST that lack KIT exon 11 mutations (Cohort B) ponatinib: 45 mg, taken orally once-daily.
122686|NCT01874665|O1|Outcome|Cohort A|Participants with KIT exon 11-mutant GIST ponatinib: 45 mg, taken orally once-daily.
122687|NCT01874665|O2|Outcome|Cohort B|Participants with GIST that lack KIT exon 11 mutations (Cohort B) ponatinib: 45 mg, taken orally once-daily.
122688|NCT01874665|O1|Outcome|Cohort A|Participants with KIT exon 11-mutant GIST ponatinib: 45 mg, taken orally once-daily.
122689|NCT01874665|O1|Outcome|Cohort B|Participants with GIST that lack KIT exon 11 mutations (Cohort B) ponatinib: 45 mg, taken orally once-daily.
122690|NCT01874665|O1|Outcome|Cohort A|Participants with KIT exon 11-mutant GIST ponatinib: 45 mg, taken orally once-daily.
122691|NCT01874665|E2|Reported Event|Cohort B|Participants with GIST that lack KIT exon 11 mutations (Cohort B) ponatinib: 45 mg, taken orally once-daily.
122692|NCT01874665|E1|Reported Event|Cohort A|Participants with KIT exon 11-mutant GIST ponatinib: 45 mg, taken orally once-daily.
122693|NCT01874353|B3|Baseline|Total|Total of all reporting groups
122694|NCT01874353|B2|Baseline|Placebo Tablets|Taken orally twice daily
122695|NCT01874353|B1|Baseline|Olaparib 300mg Tablets|Taken orally twice daily
122696|NCT01874353|P2|Participant Flow|Placebo Tablets|Taken orally twice daily
122697|NCT01874353|P1|Participant Flow|Olaparib 300mg Tablets|Taken orally twice daily
122698|NCT01874353|O1|Outcome|Olaparib 300mg Tablets|Taken orally twice daily
122699|NCT01874353|O2|Outcome|Placebo Tablets|Taken orally twice daily
122700|NCT01874353|O1|Outcome|Olaparib 300mg Tablets|Taken orally twice daily
122701|NCT01874353|O2|Outcome|Placebo Tablets|Taken orally twice daily
122702|NCT01874353|O1|Outcome|Olaparib 300mg Tablets|Taken orally twice daily
122703|NCT01874353|O2|Outcome|Placebo Tablets|Taken orally twice daily
122704|NCT01874353|O1|Outcome|Olaparib 300mg Tablets|Taken orally twice daily
122705|NCT01874353|O2|Outcome|Placebo Tablets|Taken orally twice daily
122706|NCT01874353|O1|Outcome|Olaparib 300mg Tablets|Taken orally twice daily
122707|NCT01874353|O2|Outcome|Placebo Tablets|Taken orally twice daily
122708|NCT01874353|O1|Outcome|Olaparib 300mg Tablets|Taken orally twice daily
122709|NCT01874353|O2|Outcome|Placebo Tablets|Taken orally twice daily
122710|NCT01874353|O1|Outcome|Olaparib 300mg Tablets|Taken orally twice daily
122711|NCT01874353|O2|Outcome|Placebo Tablets|Taken orally twice daily
122712|NCT01874353|O1|Outcome|Olaparib 300mg Tablets|Taken orally twice daily
122713|NCT01874353|O2|Outcome|Placebo Tablets|Taken orally twice daily
122714|NCT01874353|O1|Outcome|Olaparib 300mg Tablets|Taken orally twice daily
122715|NCT01874353|O2|Outcome|Placebo Tablets|Taken orally twice daily
122716|NCT01874353|O1|Outcome|Olaparib 300mg Tablets|Taken orally twice daily
122717|NCT01874353|E2|Reported Event|Placebo Tablets|
122718|NCT01874353|E1|Reported Event|Olaparib 300mg Tablets|
122719|NCT01874340|B5|Baseline|Total|Total of all reporting groups
122720|NCT01874340|B4|Baseline|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122721|NCT01874340|B3|Baseline|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122722|NCT01874340|B2|Baseline|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122723|NCT01874340|B1|Baseline|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122724|NCT01874340|P4|Participant Flow|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122725|NCT01874340|P3|Participant Flow|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122726|NCT01874340|P2|Participant Flow|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122727|NCT01874340|P1|Participant Flow|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122728|NCT01874340|O4|Outcome|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122729|NCT01874340|O3|Outcome|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122730|NCT01874340|O2|Outcome|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122731|NCT01874340|O1|Outcome|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122732|NCT01874340|O4|Outcome|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122847|NCT01873989|B3|Baseline|Total|Total of all reporting groups
122733|NCT01874340|O3|Outcome|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122734|NCT01874340|O2|Outcome|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122735|NCT01874340|O1|Outcome|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122736|NCT01874340|O4|Outcome|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122737|NCT01874340|O3|Outcome|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122738|NCT01874340|O2|Outcome|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122739|NCT01874340|O1|Outcome|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122740|NCT01874340|O4|Outcome|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122741|NCT01874340|O3|Outcome|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122742|NCT01874340|O2|Outcome|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122743|NCT01874340|O1|Outcome|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122744|NCT01874340|O4|Outcome|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122745|NCT01874340|O3|Outcome|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122746|NCT01874340|O2|Outcome|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122747|NCT01874340|O1|Outcome|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122748|NCT01874340|E4|Reported Event|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122749|NCT01874340|E3|Reported Event|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122750|NCT01874340|E2|Reported Event|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122751|NCT01874340|E1|Reported Event|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
122752|NCT01874275|B3|Baseline|Total|Total of all reporting groups
122753|NCT01874275|B2|Baseline|Device Sham|placebo treatment - no nerve stimulator treatment twice daily for 180 days of study
122754|NCT01874275|B1|Baseline|VECTTOR - Active|nerve stimulator treatment twice daily for duration of study - 365 days ...
122755|NCT01874275|P2|Participant Flow|Device - Sham|"placebo treatment - no electrical stimulation treatment twice daily for 180 days followed by active treatment for the duration of study, 365 days~VECTTOR: The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on the acupuncture points of a patient’s feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain.~Once these electrodes are placed, the machine determines the appropriate choice of stimulation by automatically measuring body temperatures through the use of thermistors placed on the fingers during a testing sequence."
122756|NCT01874275|P1|Participant Flow|VECTTOR|"muscle stimulator treatment twice daily for duration of study - 365 days~VECTTOR: The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on the acupuncture points of a patient’s feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain.~Once these electrodes are placed, the machine determines the appropriate choice of stimulation by automatically measuring body temperatures through the use of thermistors placed on the fingers during a testing sequence."
122757|NCT01874275|O1|Outcome|VECTTOR|Muscle strength testing (Wireless Tracker system) - All muscle strength testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90, 180 and 365 days to determine changes in muscle strength. JTech computerized testing system determined the muscle strength by radio signals from a strain gauge measuring strength of the participant's muscles. 44 separate tests were performed for muscle strength for each participant at each time interval. Efficacy is defined as an increase in the strength measurement (pounds) from Baseline to 365 days.
122758|NCT01874275|O1|Outcome|VECTTOR|Range of Motion (ROM) testing (Wireless Tracker System) - All muscle and joint testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90, 180 and 365 days to determine changes in joint Range of Motion. JTech computerized testing system determined the joint range of motion by radio signals from a goniometer measuring movement of the participants' joints. 44 separate tests were performed for Range of Motion for each participant at each time interval. The results from the range of motion tests were averaged the percent change from baseline to 365 days. Efficacy is defined as an increase in range of motion.
122759|NCT01874275|O2|Outcome|Device - Sham|"placebo treatment - no electrical stimulation treatment twice daily for 180 days~VECTTOR: The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on the acupuncture points of a patient’s feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain.~Once these electrodes are placed, the machine determines the appropriate choice of stimulation by automatically measuring body temperatures through the use of thermistors placed on the fingers during a testing sequence."
122760|NCT01874275|O1|Outcome|VECTTOR|"nerve stimulator treatment twice daily for duration of study - 180 days~VECTTOR: The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on the acupuncture points of a patient’s feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain.~Once these electrodes are placed, the machine determines the appropriate choice of stimulation by automatically measuring body temperatures through the use of thermistors placed on the fingers during a testing sequence."
122761|NCT01874275|O2|Outcome|Device - Sham|placebo treatment - no electrical stimulation treatment twice daily for 180 days followed by muscle stimulator treatment twice daily for 180 days
122763|NCT01874275|O2|Outcome|Device - Sham|placebo treatment - no electrical stimulation treatment twice daily for 180 days followed by cross-over with active treatment for the next 180 days
122764|NCT01874275|O1|Outcome|VECTTOR|nerve stimulator treatment twice daily for duration of study - assessed at 180 days
122765|NCT01874275|E2|Reported Event|Device - Sham|placebo treatment - no electrical stimulation treatment twice daily for 180 days followed by cross-over with active treatment for the next 180 days
122766|NCT01874275|E1|Reported Event|VECTTOR|nerve stimulator treatment twice daily for duration of study - 365 days ...
122767|NCT01874262|B3|Baseline|Total|Total of all reporting groups
122768|NCT01874262|B2|Baseline|E-diary|In this group the patients had access to the e-diary only, in which they reported their daily use of ticagrelor. Patients did not receive any feed-back except a reminder in case of a missing ticagrelor registration (which was applicable also for the other group receiving e-diary + the mobile-phone based patient support).
122769|NCT01874262|B1|Baseline|E-diary + Mobile-phone Based Patient Support|The software application used on the patients' smart phones in this group, contained both the e-diary and the mobile-phone based patient support. Patients received feedback by the mobile-phone based patient support not only on the data they entered into the mobile-phone based patient support but also on their reported daily ticagrelor use.
122770|NCT01874262|P2|Participant Flow|E-diary|In this group the patients had access to the e-diary only, in which they reported their daily use of ticagrelor. Patients did not receive any feed-back except a reminder in case of a missing ticagrelor registration (which was applicable also for the other group receiving e-diary + the mobile-phone based patient support).
122771|NCT01874262|P1|Participant Flow|E-diary + Mobile-phone Based Patient Support|The software application used on the patients' smart phones in this group, contained both the e-diary and the mobile-phone based patient support. Patients received feedback by the mobile-phone based patient support not only on the data they entered into the mobile-phone based patient support but also on their reported daily ticagrelor use.
122772|NCT01874262|O2|Outcome|E-diary|In this group the patients had access to the e-diary only, in which they reported their daily use of ticagrelor. Patients did not receive any feed-back except a reminder in case of a missing ticagrelor registration (which was applicable also for the other group receiving e-diary + the mobile-phone based patient support).
122773|NCT01874262|O1|Outcome|E-diary + Mobile-phone Based Patient Support|The software application used on the patients' smart phones in this group, contained both the e-diary and the mobile-phone based patient support. Patients received feedback by the mobile-phone based patient support not only on the data they entered into the mobile-phone based patient support but also on their reported daily ticagrelor use.
122774|NCT01874262|E2|Reported Event|E-diary|In this group the patients had access to the e-diary only, in which they reported their daily use of ticagrelor. Patients did not receive any feed-back except a reminder in case of a missing ticagrelor registration (which was applicable also for the other group receiving e-diary + the mobile-phone based patient support).
122775|NCT01874262|E1|Reported Event|E-diary + Mobile-phone Based Patient Support|The software application used on the patients' smart phones in this group, contained both the e-diary and the mobile-phone based patient support. Patients received feedback by the mobile-phone based patient support not only on the data they entered into the mobile-phone based patient support but also on their reported daily ticagrelor use.
122776|NCT01874145|B3|Baseline|Total|Total of all reporting groups
122777|NCT01874145|B2|Baseline|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
122778|NCT01874145|B1|Baseline|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
122779|NCT01874145|P2|Participant Flow|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
122780|NCT01874145|P1|Participant Flow|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
122781|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
122782|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
122783|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
122784|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
122785|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
122786|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
122787|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
122788|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
122789|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
122790|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
122791|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
122792|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
122793|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
122794|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
122795|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
122796|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
122797|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
122798|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
122799|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
122800|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
122801|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
122802|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
122803|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
122804|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
122805|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
122806|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
122807|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
122808|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
122809|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
122810|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
122811|NCT01874145|E4|Reported Event|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
122812|NCT01874145|E3|Reported Event|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
122848|NCT01873989|B2|Baseline|Waitlist Control|"This arm involves watchful waiting.~Waitlist control"
122813|NCT01874145|E2|Reported Event|GA 40 mg/mL TIW (Core)|Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.
122814|NCT01874145|E1|Reported Event|GA 20 mg/mL QD (Core)|Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.
122815|NCT01874132|B4|Baseline|Total|Total of all reporting groups
122816|NCT01874132|B3|Baseline|Control|Non-exercising control group
122817|NCT01874132|B2|Baseline|Aerobic and Resistance Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
122818|NCT01874132|B1|Baseline|Aerobic Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
122819|NCT01874132|P3|Participant Flow|Control|Non-exercising control group
122820|NCT01874132|P2|Participant Flow|Aerobic and Resistance Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
122821|NCT01874132|P1|Participant Flow|Aerobic Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
122822|NCT01874132|O3|Outcome|Control|Non-exercising control group
122823|NCT01874132|O2|Outcome|Aerobic and Resistance Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
122824|NCT01874132|O1|Outcome|Aerobic Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
122825|NCT01874132|O3|Outcome|Control|Non-exercising control group
122826|NCT01874132|O2|Outcome|Aerobic and Resistance Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
122827|NCT01874132|O1|Outcome|Aerobic Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
122828|NCT01874132|E3|Reported Event|Control|Non-exercising control group
122829|NCT01874132|E2|Reported Event|Aerobic and Resistance Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
122830|NCT01874132|E1|Reported Event|Aerobic Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
122831|NCT01874119|B1|Baseline|Study Participants Completing All Cycles|"Fosaprepitant: During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission~Placebo: intravenous 0.9% saline every 48 hours during 6-day hospital admission"
122832|NCT01874119|P2|Participant Flow|Placebo First, Then Fosaprepitant|"Placebo: During placebo admission, intravenous 0.9% saline every 48 hours during 6-day hospital admission~Fosaprepitant: During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission"
122833|NCT01874119|P1|Participant Flow|Fosaprepitant First, Then Placebo|"Fosaprepitant: During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission~Placebo: During placebo admission, intravenous 0.9% saline every 48 hours during 6-day hospital admission"
122834|NCT01874119|O2|Outcome|Placebo|"During placebo admission, intravenous 0.9% saline every 48 hours during 6-day hospital admission~Fosaprepitant: During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission"
122835|NCT01874119|O1|Outcome|Fosaprepitant|"During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission~Fosaprepitant: During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission"
122836|NCT01874119|E2|Reported Event|Placebo|"During placebo admission, intravenous 0.9% saline every 48 hours during 6-day hospital admission~Fosaprepitant: During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission"
122837|NCT01874119|E1|Reported Event|Fosaprepitant|"During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission~Fosaprepitant: During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission"
122838|NCT01874054|B1|Baseline|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine~brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion~bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
122839|NCT01874054|P1|Participant Flow|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine~brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion~bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
122840|NCT01874054|O1|Outcome|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine~brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion~bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
122841|NCT01874054|O1|Outcome|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine~brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion~bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
122842|NCT01874054|O1|Outcome|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine~brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion~bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
122843|NCT01874054|O1|Outcome|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine~brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion~bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
122844|NCT01874054|O1|Outcome|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine~brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion~bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
122845|NCT01874054|O1|Outcome|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine~brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion~bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
122846|NCT01874054|E1|Reported Event|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine~brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion~bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
122849|NCT01873989|B1|Baseline|Testosterone Replacement|"Testosterone replacement for hypogonadism.~Testosterone replacement"
122850|NCT01873989|P2|Participant Flow|Waitlist Control|"This arm involves watchful waiting.~Waitlist control"
122851|NCT01873989|P1|Participant Flow|Testosterone Replacement|"Testosterone replacement for hypogonadism.~Testosterone replacement"
122852|NCT01873989|O2|Outcome|Waitlist Control|"This arm involves watchful waiting.~Waitlist control"
122853|NCT01873989|O1|Outcome|Testosterone Replacement|"Testosterone replacement for hypogonadism.~Testosterone replacement"
122854|NCT01873989|O2|Outcome|Waitlist Control|"This arm involves watchful waiting.~Waitlist control"
122855|NCT01873989|O1|Outcome|Testosterone Replacement|"Testosterone replacement for hypogonadism.~Testosterone replacement"
122856|NCT01873989|O2|Outcome|Waitlist Control|"This arm involves watchful waiting.~Waitlist control"
122857|NCT01873989|O1|Outcome|Testosterone Replacement|"Testosterone replacement for hypogonadism.~Testosterone replacement"
122858|NCT01873989|E2|Reported Event|Waitlist Control|"This arm involves watchful waiting.~Waitlist control"
122859|NCT01873989|E1|Reported Event|Testosterone Replacement|"Testosterone replacement for hypogonadism.~Testosterone replacement"
122860|NCT01873950|B1|Baseline|All Study Participants|Participants who were randomized to receive either ranolazine, dofetilide, verapamil, quinidine or placebo.
122861|NCT01873950|P5|Participant Flow|Placebo|Single oral dose of Placebo (comparison group). Each subject received each drug only once in a randomized sequence (10 sequences in total).
122862|NCT01873950|P4|Participant Flow|Quinidine Sulfate 400 mg|Single oral dose of Quinidine sulfate 400mg. Each subject received each drug only once in a randomized sequence (10 sequences in total).
122863|NCT01873950|P3|Participant Flow|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg. Each subject received each drug only once in a randomized sequence (10 sequences in total).
122864|NCT01873950|P2|Participant Flow|Dofetilide 500 mcg|Single oral dose of Dofetilide 500mcg. Each subject received each drug only once in a randomized sequence (10 sequences in total).
122865|NCT01873950|P1|Participant Flow|Ranolazine 1500 mg|Single oral dose of Ranolazine 1500mg. Each subject received each drug only once in a randomized sequence (10 sequences in total).
122866|NCT01873950|O2|Outcome|Quinidine Sulfate 400mg|Single oral dose of Quinidine sulfate 400mg
122867|NCT01873950|O1|Outcome|Ranolazine 1500mg|Single oral dose of Ranolazine 1500mg
122868|NCT01873950|O2|Outcome|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg
122869|NCT01873950|O1|Outcome|Dofetilide 500mcg|Single oral dose of Dofetilide 500mcg
122870|NCT01873950|O2|Outcome|Quinidine Sulfate 400mg|Single oral dose of Quinidine sulfate 400mg
122871|NCT01873950|O1|Outcome|Ranolazine 1500mg|Single oral dose of Ranolazine 1500mg
122872|NCT01873950|O2|Outcome|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg
122873|NCT01873950|O1|Outcome|Dofetilide 500mcg|Single oral dose of Dofetilide 500mcg
122874|NCT01873950|O2|Outcome|Quinidine Sulfate 400mg|Single oral dose of Quinidine sulfate 400mg
122875|NCT01873950|O1|Outcome|Ranolazine 1500mg|Single oral dose of Ranolazine 1500mg
122876|NCT01873950|O2|Outcome|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg
122877|NCT01873950|O1|Outcome|Dofetilide 500mcg|Single oral dose of Dofetilide 500mcg
122878|NCT01873950|O4|Outcome|Quinidine Sulfate 400mg|Single oral dose of Quinidine sulfate 400mg
122879|NCT01873950|O3|Outcome|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg
122880|NCT01873950|O2|Outcome|Dofetilide 500mcg|Single oral dose of Dofetilide 500mcg
122881|NCT01873950|O1|Outcome|Ranolazine 1500mg|Single oral dose of Ranolazine 1500mg
122882|NCT01873950|O4|Outcome|Quinidine Sulfate 400mg|Single oral dose of Quinidine sulfate 400mg
122883|NCT01873950|O3|Outcome|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg
122884|NCT01873950|O2|Outcome|Dofetilide 500mcg|Single oral dose of Dofetilide 500mcg
122885|NCT01873950|O1|Outcome|Ranolazine 1500mg|Single oral dose of Ranolazine 1500mg
122886|NCT01873950|O4|Outcome|Quinidine Sulfate 400mg|Single oral dose of Quinidine sulfate 400mg
122887|NCT01873950|O3|Outcome|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg
122888|NCT01873950|O2|Outcome|Dofetilide 500mcg|Single oral dose of Dofetilide 500mcg
122889|NCT01873950|O1|Outcome|Ranolazine 1500mg|Single oral dose of Ranolazine 1500mg
122890|NCT01873950|O4|Outcome|Quinidine Sulfate 400mg|Single oral dose of Quinidine sulfate 400mg
122891|NCT01873950|O3|Outcome|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg
122892|NCT01873950|O2|Outcome|Dofetilide 500mcg|Single oral dose of Dofetilide 500mcg
122893|NCT01873950|O1|Outcome|Ranolazine 1500mg|Single oral dose of Ranolazine 1500mg
122894|NCT01873950|E5|Reported Event|Placebo|Single oral dose of Placebo (comparison group)
122895|NCT01873950|E4|Reported Event|Quinidine Sulfate 400mg|Single oral dose of Quinidine sulfate 400mg
122896|NCT01873950|E3|Reported Event|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg
122897|NCT01873950|E2|Reported Event|Dofetilide 500mcg|Single oral dose of Dofetilide 500mcg
122898|NCT01873950|E1|Reported Event|Ranolazine 1500mg|Single oral dose of Ranolazine 1500mg
122899|NCT01873859|B3|Baseline|Total|Total of all reporting groups
122900|NCT01873859|B2|Baseline|Off-metformin|Diabetic patients receiving contrast media with discontinuation of metformin.
122901|NCT01873859|B1|Baseline|On-metformin|"Diabetic patients receiving contrast media without discontinuing metformin.~Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin."
122902|NCT01873859|P2|Participant Flow|Off-metformin|Diabetic patients receiving contrast media with discontinuation of metformin.
122903|NCT01873859|P1|Participant Flow|On-metformin|"Diabetic patients receiving contrast media without discontinuing metformin.~Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin."
122904|NCT01873859|O2|Outcome|Off-metformin|Diabetic patients receiving contrast media with discontinuation of metformin.
122942|NCT01872910|O3|Outcome|Part A - Placebo|Placebo: Administered orally once as a capsule post dental surgery.
122905|NCT01873859|O1|Outcome|On-metformin|"Diabetic patients receiving contrast media without discontinuing metformin.~Metformin: rise of creatinin 48 hr after recieving contrast media."
122906|NCT01873859|O2|Outcome|Off-metformin|Diabetic patients receiving contrast media with discontinuation of metformin.
122907|NCT01873859|O1|Outcome|On-metformin|"Diabetic patients receiving contrast media without discontinuing metformin.~Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin."
122908|NCT01873859|E2|Reported Event|Off-metformin|Diabetic patients receiving contrast media with discontinuation of metformin.
122909|NCT01873859|E1|Reported Event|On-metformin|"Diabetic patients receiving contrast media without discontinuing metformin.~Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin."
122910|NCT01873729|B1|Baseline|Naltrexone|"Naltrexone~Naltrexone: Adults with ADHD"
122911|NCT01873729|P1|Participant Flow|Naltrexone|"Naltrexone~Naltrexone: Adults with ADHD"
122912|NCT01873729|O1|Outcome|Naltrexone|"Naltrexone + Methylphenidate Spheroidal Oral Drug Absorption System (MPH-SODAS)~Naltrexone: Adults with ADHD"
122913|NCT01873729|O1|Outcome|Naltrexone|"Naltrexone + Methylphenidate Spheroidal Oral Drug Absorption System (MPH-SODAS)~Naltrexone: Adults with ADHD"
122914|NCT01873729|E1|Reported Event|Naltrexone|"Naltrexone~Naltrexone: Adults with ADHD"
122915|NCT01873417|B1|Baseline|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
122916|NCT01873417|P1|Participant Flow|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
122917|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
122918|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
122919|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
122920|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
122921|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
122922|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
122923|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
122924|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
122925|NCT01873417|E1|Reported Event|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
122926|NCT01872910|B7|Baseline|Total|Total of all reporting groups
122927|NCT01872910|B6|Baseline|Pre-Part B - Celecoxib|Celecoxib: Administered orally once as two 200-mg capsules, post dental surgery and post dialysate probe placement.
122928|NCT01872910|B5|Baseline|Part B - Placebo|Placebo: Administered orally once as a capsule, post dental surgery and post dialysate probe placement.
122929|NCT01872910|B4|Baseline|Part B - LY3023703|LY3023703: Administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement.
122930|NCT01872910|B3|Baseline|Part A - Placebo|Placebo: Administered orally once as a capsule post dental surgery.
122931|NCT01872910|B2|Baseline|Part A - Celecoxib|Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control).
122932|NCT01872910|B1|Baseline|Part A - LY3023703|LY3023703: Administered orally once as a 30-mg capsule post dental surgery.
122933|NCT01872910|P6|Participant Flow|Pre-Part B - Celecoxib|Celecoxib: Administered orally once as two 200-mg capsules, post dental surgery and post dialysate probe placement. Prior to Part B, there was a technique transfer and training conducted to allow the site to develop proficiency in dialysate placement, collection and maintenance techniques.
122934|NCT01872910|P5|Participant Flow|Part B - Placebo|Placebo: Administered orally once as a capsule, post dental surgery and post dialysate probe placement.
122935|NCT01872910|P4|Participant Flow|Part B - LY3023703|LY3023703: Administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement.
122936|NCT01872910|P3|Participant Flow|Part A - Placebo|Placebo: Administered orally once as a capsule post dental surgery.
122937|NCT01872910|P2|Participant Flow|Part A - Celecoxib|Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control).
122938|NCT01872910|P1|Participant Flow|Part A - LY3023703|LY3023703: Administered orally once as a 30-milligrams (mg) capsule post dental surgery.
122939|NCT01872910|O3|Outcome|Part A - Placebo|Placebo: Administered orally once as a capsule post dental surgery.
122940|NCT01872910|O2|Outcome|Part A - Celecoxib|Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control).
122941|NCT01872910|O1|Outcome|Part A - LY3023703|LY3023703: Administered orally once as a 30-mg capsule post dental surgery.
122943|NCT01872910|O2|Outcome|Part A - Celecoxib|Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control).
122944|NCT01872910|O1|Outcome|Part A - LY3023703|LY3023703: Administered orally once as a 30-mg capsule post dental surgery.
122945|NCT01872910|O3|Outcome|Part A - Placebo|Placebo: Administered orally once as a capsule post dental surgery.
122946|NCT01872910|O2|Outcome|Part A - Celecoxib|Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control).
122947|NCT01872910|O1|Outcome|Part A - LY3023703|LY3023703: Administered orally once as a 30-mg capsule post dental surgery.
122948|NCT01872910|O5|Outcome|Part B - Placebo|Placebo: Administered orally once as a capsule, post dental surgery and post dialysate probe placement.
122949|NCT01872910|O4|Outcome|Part B - LY3023703|LY3023703: Administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement.
122950|NCT01872910|O3|Outcome|Part A - Placebo|Placebo: Administered orally once as a capsule post dental surgery.
122951|NCT01872910|O2|Outcome|Part A - Celecoxib|Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control).
122952|NCT01872910|O1|Outcome|Part A - LY3023703|LY3023703: Administered orally once as a 30-mg capsule post dental surgery.
122953|NCT01872910|O5|Outcome|Part B - Placebo|Placebo: Administered orally once as a capsule, post dental surgery and post dialysate probe placement.
122954|NCT01872910|O4|Outcome|Part B - LY3023703|LY3023703: Administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement.
122955|NCT01872910|O3|Outcome|Part A - Placebo|Placebo: Administered orally once as a capsule post dental surgery.
122956|NCT01872910|O2|Outcome|Part A - Celecoxib|Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control).
122957|NCT01872910|O1|Outcome|Part A - LY3023703|LY3023703: Administered orally once as a 30-mg capsule post dental surgery.
122958|NCT01872910|O5|Outcome|Part B - Placebo|Placebo: Administered orally once as a capsule, post dental surgery and post dialysate probe placement.
122959|NCT01872910|O4|Outcome|Part B - LY3023703|LY3023703: Administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement.
122960|NCT01872910|O3|Outcome|Part A - Placebo|Placebo: Administered orally once as a capsule post dental surgery.
122961|NCT01872910|O2|Outcome|Part A - Celecoxib|Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control).
122962|NCT01872910|O1|Outcome|Part A - LY3023703|LY3023703: Administered orally once as a 30-mg capsule post dental surgery.
122963|NCT01872910|O5|Outcome|Part B - Placebo|Placebo: Administered orally once as a capsule, post dental surgery and post dialysate probe placement.
122964|NCT01872910|O4|Outcome|Part B - LY3023703|LY3023703: Administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement.
122965|NCT01872910|O3|Outcome|Part A - Placebo|Placebo: Administered orally once as a capsule post dental surgery.
122966|NCT01872910|O2|Outcome|Part A - Celecoxib|Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control).
122967|NCT01872910|O1|Outcome|Part A - LY3023703|LY3023703: Administered orally once as a 30-mg capsule post dental surgery.
122968|NCT01872910|O3|Outcome|Part A - Placebo|Placebo: Administered orally once as a capsule post dental surgery.
122969|NCT01872910|O2|Outcome|Part A - Celecoxib|Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control).
122970|NCT01872910|O1|Outcome|Part A - LY3023703|LY3023703: Administered orally once as a 30-mg capsule post dental surgery.
122971|NCT01872910|E6|Reported Event|Pre-Part B - Celecoxib|Celecoxib: Administered orally once as two 200-mg capsules, post dental surgery and post dialysate probe placement.
122972|NCT01872910|E5|Reported Event|Part B - Placebo|Placebo: Administered orally once as a capsule, post dental surgery and post dialysate probe placement.
122973|NCT01872910|E4|Reported Event|Part B - LY3023703|LY3023703: Administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement.
122974|NCT01872910|E3|Reported Event|Part A - Placebo|Placebo: Administered orally once as a capsule post dental surgery.
122975|NCT01872910|E2|Reported Event|Part A - Celecoxib|Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control).
122976|NCT01872910|E1|Reported Event|Part A - LY3023703|LY3023703: Administered orally once as a 30-mg capsule post dental surgery.
122977|NCT01872819|B1|Baseline|Treatment (Chemotherapy, Biological Therapy)|"Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity assay.~antitumor drug screening assay: Undergo high throughput drug sensitivity assay~chemotherapy: Patients receive 1 of 160 possible interventions~biological therapy: Patients receive 1 of 160 possible interventions"
122978|NCT01872819|P1|Participant Flow|Treatment (Chemotherapy, Biological Therapy)|"Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity assay.~antitumor drug screening assay: Undergo high throughput drug sensitivity assay~chemotherapy: Patients receive 1 of 160 possible interventions~biological therapy: Patients receive 1 of 160 possible interventions~16 patients were enrolled. 14 patients were treated."
122979|NCT01872819|O1|Outcome|Treated Patients|
122980|NCT01872819|O1|Outcome|Treated Patients|14 patients were treated.
122981|NCT01872819|E1|Reported Event|Treatment (Chemotherapy, Biological Therapy)|"Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity assay.~antitumor drug screening assay: Undergo high throughput drug sensitivity assay~chemotherapy: Patients receive 1 of 160 possible interventions~biological therapy: Patients receive 1 of 160 possible interventions"
122982|NCT01872715|B1|Baseline|Oracea|"Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.~Oral dose for 12 weeks~Oracea"
122983|NCT01872715|P1|Participant Flow|Oracea|"Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.~Oral dose for 12 weeks~Oracea"
122984|NCT01872715|O5|Outcome|Very Dissatisfied|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
122985|NCT01872715|O4|Outcome|Dissatisfied|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
122986|NCT01872715|O3|Outcome|Neither Satisfied Nor Dissatisfied|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
122987|NCT01872715|O2|Outcome|Satisfied|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
122988|NCT01872715|O1|Outcome|Very Satisfied|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
122989|NCT01872715|O5|Outcome|4 = Severe|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
122990|NCT01872715|O4|Outcome|3 = Moderate|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
122991|NCT01872715|O3|Outcome|2 = Mild|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
122992|NCT01872715|O2|Outcome|1 = Near Clear|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
122993|NCT01872715|O1|Outcome|0 = Clear|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
122994|NCT01872715|O1|Outcome|Oracea|"Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.~Oral dose for 12 weeks~Oracea"
122995|NCT01872715|O1|Outcome|Oracea|"Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.~Oral dose for 12 weeks~Oracea"
122996|NCT01872715|E1|Reported Event|Oracea|"Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.~Oral dose for 12 weeks~Oracea"
122997|NCT01872611|B3|Baseline|Total|Total of all reporting groups
122998|NCT01872611|B2|Baseline|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
122999|NCT01872611|B1|Baseline|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
123000|NCT01872611|P2|Participant Flow|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
123001|NCT01872611|P1|Participant Flow|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
123002|NCT01872611|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
123003|NCT01872611|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
123004|NCT01872611|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
123005|NCT01872611|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
123006|NCT01872611|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
123007|NCT01872611|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
123008|NCT01872611|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
123009|NCT01872611|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
123010|NCT01872611|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
123011|NCT01872611|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
123012|NCT01872611|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
123013|NCT01872611|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
123014|NCT01872611|E4|Reported Event|Posttreatment|All participants after cessation of study treatment up to study exit
123015|NCT01872611|E3|Reported Event|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
123016|NCT01872611|E2|Reported Event|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
123017|NCT01872611|E1|Reported Event|Pretreatment|All participants who consented to participate in the study prior to the initiation of study treatment
123018|NCT01872078|B5|Baseline|Total|Total of all reporting groups
123019|NCT01872078|B4|Baseline|40 mg AZD4901 Twice Daily|Two 20-mg AZD4901 tablets for both the morning and evening doses
123020|NCT01872078|B3|Baseline|20 mg AZD4901 Twice Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for both the morning and evening doses
123021|NCT01872078|B2|Baseline|20 mg AZD4901 Once Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for the morning dose and 2 placebo tablets for the evening dose
123022|NCT01872078|B1|Baseline|Placebo|Two matching placebo tablets for both the morning and evening doses
123023|NCT01872078|P4|Participant Flow|40 mg AZD4901 Twice Daily|Two 20-mg AZD4901 tablets for both the morning and evening doses
123024|NCT01872078|P3|Participant Flow|20 mg AZD4901 Twice Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for both the morning and evening doses
123025|NCT01872078|P2|Participant Flow|20 mg AZD4901 Once Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for the morning dose and 2 placebo tablets for the evening dose
123026|NCT01872078|P1|Participant Flow|Placebo|Two matching placebo tablets for both the morning and evening doses
123027|NCT01872078|O4|Outcome|40 mg AZD4901 Bid|40 mg AZD4901 twice daily administered orally
123028|NCT01872078|O3|Outcome|20 mg AZD4901 Bid|20 mg AZD4901 twice daily administered orally
123029|NCT01872078|O2|Outcome|20 mg AZD4901 qd|20 mg AZD4901 once daily administered orally
123030|NCT01872078|O1|Outcome|Placebo|Two matching placebo tablets for both the morning and evening doses
123031|NCT01872078|E4|Reported Event|Placebo|Two matching placebo tablets for both the morning and evening doses
123032|NCT01872078|E3|Reported Event|40 mg AZD4901 Twice Daily|Two 20-mg AZD4901 tablets for both the morning and evening doses
123033|NCT01872078|E2|Reported Event|20 mg AZD4901 Twice Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for both the morning and evening doses
123034|NCT01872078|E1|Reported Event|20 mg AZD4901 Once Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for the morning dose and 2 placebo tablets for the evening dose
123035|NCT01871870|B1|Baseline|Artificial Pancreas Control Software|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone."
123036|NCT01871870|P1|Participant Flow|Artificial Pancreas Control Software|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone."
123037|NCT01871870|O1|Outcome|Artificial Pancreas Control Software|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone."
123038|NCT01871870|O1|Outcome|Artificial Pancreas Control Software|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone."
123039|NCT01871870|E1|Reported Event|Artificial Pancreas Control Software|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone."
123040|NCT01871805|B7|Baseline|Total|Total of all reporting groups
123041|NCT01871805|B6|Baseline|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123042|NCT01871805|B5|Baseline|Alectinib 900 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123043|NCT01871805|B4|Baseline|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123044|NCT01871805|B3|Baseline|Alectinib 600 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123045|NCT01871805|B2|Baseline|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123046|NCT01871805|B1|Baseline|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123047|NCT01871805|P6|Participant Flow|Alectinib 600 mg (Fed): Phase II|Participants received 150 mg alectinib capsules orally to make a dose of 600 mg BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123048|NCT01871805|P5|Participant Flow|Alectinib 900 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123049|NCT01871805|P4|Participant Flow|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123050|NCT01871805|P3|Participant Flow|Alectinib 600 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123051|NCT01871805|P2|Participant Flow|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123052|NCT01871805|P1|Participant Flow|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 milligrams (mg) alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg twice daily (BID) dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123053|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123054|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123055|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123056|NCT01871805|O7|Outcome|Alectinib 900 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123057|NCT01871805|O6|Outcome|Alectinib 900 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123058|NCT01871805|O5|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123059|NCT01871805|O4|Outcome|Alectinib 600 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123060|NCT01871805|O3|Outcome|Alectinib 600 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123061|NCT01871805|O2|Outcome|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123062|NCT01871805|O1|Outcome|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123063|NCT01871805|O9|Outcome|Alectinib 900 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123064|NCT01871805|O8|Outcome|Alectinib 900 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123065|NCT01871805|O7|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123066|NCT01871805|O6|Outcome|Alectinib 600 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123067|NCT01871805|O5|Outcome|Alectinib 600 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123068|NCT01871805|O4|Outcome|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123069|NCT01871805|O3|Outcome|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123070|NCT01871805|O2|Outcome|Alectinib 240 mg Once and 300 mg BID (Fed): Phase I|Participants (in non-fasting condition) received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123071|NCT01871805|O1|Outcome|Alectinib 240 mg Once and 300 mg BID (Fasted): Phase I|Participants (in fasting condition) received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123072|NCT01871805|O7|Outcome|Alectinib 900 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123073|NCT01871805|O6|Outcome|Alectinib 900 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123074|NCT01871805|O5|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123075|NCT01871805|O4|Outcome|Alectinib 600 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123076|NCT01871805|O3|Outcome|Alectinib 600 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123077|NCT01871805|O2|Outcome|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123078|NCT01871805|O1|Outcome|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123079|NCT01871805|O9|Outcome|Alectinib 900 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123080|NCT01871805|O8|Outcome|Alectinib 900 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123081|NCT01871805|O7|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123082|NCT01871805|O6|Outcome|Alectinib 600 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123083|NCT01871805|O5|Outcome|Alectinib 600 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123084|NCT01871805|O4|Outcome|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123085|NCT01871805|O3|Outcome|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123086|NCT01871805|O2|Outcome|Alectinib 240 mg Once and 300 mg BID (Fed): Phase I|Participants (in non-fasting condition) received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123087|NCT01871805|O1|Outcome|Alectinib 240 mg Once and 300 mg BID (Fasted): Phase I|Participants (in fasting condition) received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123088|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123089|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123090|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123091|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123092|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123093|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123094|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123095|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123096|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123097|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123098|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123099|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123100|NCT01871805|O5|Outcome|Alectinib 900 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123215|NCT01871402|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
123101|NCT01871805|O4|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123102|NCT01871805|O3|Outcome|Alectinib 600 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123103|NCT01871805|O2|Outcome|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123104|NCT01871805|O1|Outcome|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123105|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123106|NCT01871805|O5|Outcome|Alectinib 900 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123107|NCT01871805|O4|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123108|NCT01871805|O3|Outcome|Alectinib 600 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123109|NCT01871805|O2|Outcome|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123110|NCT01871805|O1|Outcome|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123111|NCT01871805|E6|Reported Event|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123112|NCT01871805|E5|Reported Event|Alectinib 900 mg (Fed): Phase I|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123113|NCT01871805|E4|Reported Event|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123114|NCT01871805|E3|Reported Event|Alectinib 600 mg (Fed): Phase I|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123115|NCT01871805|E2|Reported Event|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123116|NCT01871805|E1|Reported Event|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
123117|NCT01871558|B3|Baseline|Total|Total of all reporting groups
123118|NCT01871558|B2|Baseline|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
123119|NCT01871558|B1|Baseline|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
123120|NCT01871558|P2|Participant Flow|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
123121|NCT01871558|P1|Participant Flow|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
123122|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
123123|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
123124|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
123125|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
123126|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
123127|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
123128|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
123129|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
123130|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
123131|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
123132|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
123133|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
123134|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
123135|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
123136|NCT01871558|E2|Reported Event|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
123137|NCT01871558|E1|Reported Event|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
123138|NCT01871532|B3|Baseline|Total|Total of all reporting groups
123139|NCT01871532|B2|Baseline|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123140|NCT01871532|B1|Baseline|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123141|NCT01871532|P2|Participant Flow|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123142|NCT01871532|P1|Participant Flow|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123143|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123144|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123145|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123146|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123147|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123148|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123149|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123150|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123151|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123152|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123153|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123154|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123155|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123156|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123157|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123158|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123159|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123160|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123161|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123162|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123163|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123164|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123165|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123166|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123167|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123168|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123169|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123170|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123171|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123172|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123173|NCT01871532|E2|Reported Event|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123174|NCT01871532|E1|Reported Event|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
123175|NCT01871519|B1|Baseline|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
123176|NCT01871519|P1|Participant Flow|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
123177|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
123178|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
123179|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
123180|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
123181|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
123182|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
123183|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
123184|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices"
123185|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
123186|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
123187|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
123188|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
123189|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
123190|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
123191|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
123192|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
123216|NCT01871402|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
123217|NCT01871402|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
123193|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
123194|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
123195|NCT01871519|E1|Reported Event|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
123196|NCT01871441|B1|Baseline|Treatment (Haploidentical Allogeneic HSCT)|"Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANT: Patients undergo haploidentical allogeneic hematopoietic stem cell transplant on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV beginning on day -1 with taper beginning on day 42, and mycophenolate mofetil IV BID from day -1 to day 28.~Total-body irradiation: Undergo TBI~Donor lymphocytes infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Allogeneic hematopoietic stem cell transplantation (HSCT): Undergo haploidentical allogeneic HSCT~Tacrolimus: Given IV~Mycophenolate mofetil: Given IV"
123197|NCT01871441|P1|Participant Flow|Treatment (Haploidentical Allogeneic HSCT)|"Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANT: Patients undergo haploidentical allogeneic hematopoietic stem cell transplant on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV beginning on day -1 with taper beginning on day 42, and mycophenolate mofetil IV BID from day -1 to day 28.~Total-body irradiation: Undergo TBI~Donor lymphocytes infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Allogeneic hematopoietic stem cell transplantation (HSCT): Undergo haploidentical allogeneic HSCT~Tacrolimus: Given IV~Mycophenolate mofetil: Given IV"
123198|NCT01871441|O1|Outcome|Treatment (Haploidentical Allogeneic HSCT)|"Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANT: Patients undergo haploidentical allogeneic hematopoietic stem cell transplant on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV beginning on day -1 with taper beginning on day 42, and mycophenolate mofetil IV BID from day -1 to day 28.~Total-body irradiation: Undergo TBI~Donor lymphocytes infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Allogeneic hematopoietic stem cell transplantation (HSCT): Undergo haploidentical allogeneic HSCT~Tacrolimus: Given IV~Mycophenolate mofetil: Given IV"
123199|NCT01871441|O1|Outcome|Treatment (Haploidentical Allogeneic HSCT)|"Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANT: Patients undergo haploidentical allogeneic hematopoietic stem cell transplant on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV beginning on day -1 with taper beginning on day 42, and mycophenolate mofetil IV BID from day -1 to day 28.~Total-body irradiation: Undergo TBI~Donor lymphocytes infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Allogeneic hematopoietic stem cell transplantation (HSCT): Undergo haploidentical allogeneic HSCT~Tacrolimus: Given IV~Mycophenolate mofetil: Given IV"
123200|NCT01871441|O1|Outcome|Treatment (Haploidentical Allogeneic HSCT)|"Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANT: Patients undergo haploidentical allogeneic hematopoietic stem cell transplant on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV beginning on day -1 with taper beginning on day 42, and mycophenolate mofetil IV BID from day -1 to day 28.~Total-body irradiation: Undergo TBI~Donor lymphocytes infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Allogeneic hematopoietic stem cell transplantation (HSCT): Undergo haploidentical allogeneic HSCT~Tacrolimus: Given IV~Mycophenolate mofetil: Given IV"
123201|NCT01871441|O1|Outcome|Treatment (Haploidentical Allogeneic HSCT)|"Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANT: Patients undergo haploidentical allogeneic hematopoietic stem cell transplant on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV beginning on day -1 with taper beginning on day 42, and mycophenolate mofetil IV BID from day -1 to day 28."
123202|NCT01871441|E1|Reported Event|Treatment (Haploidentical Allogeneic HSCT)|"Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANT: Patients undergo haploidentical allogeneic hematopoietic stem cell transplant on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV beginning on day -1 with taper beginning on day 42, and mycophenolate mofetil IV BID from day -1 to day 28.~Total-body irradiation: Undergo TBI~Donor lymphocytes infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Allogeneic hematopoietic stem cell transplantation (HSCT): Undergo haploidentical allogeneic HSCT~Tacrolimus: Given IV~Mycophenolate mofetil: Given IV"
123203|NCT01871402|B3|Baseline|Total|Total of all reporting groups
123204|NCT01871402|B2|Baseline|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
123205|NCT01871402|B1|Baseline|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
123206|NCT01871402|P2|Participant Flow|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
123207|NCT01871402|P1|Participant Flow|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
123208|NCT01871402|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
123209|NCT01871402|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
123210|NCT01871402|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
123211|NCT01871402|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
123212|NCT01871402|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
123213|NCT01871402|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
123214|NCT01871402|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
123219|NCT01871402|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
123220|NCT01871402|E2|Reported Event|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
123221|NCT01871402|E1|Reported Event|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
123222|NCT01871285|B3|Baseline|Total|Total of all reporting groups
123223|NCT01871285|B2|Baseline|MSE Dose Group 2|Morning and evening dose of buprenorphine HCl buccal film (450 μg) + placebo capsule in one period, and then placebo buccal film + over-encapsulated ATC opioid at 50% MSE daily dose in the alternate period
123224|NCT01871285|B1|Baseline|MSE Dose Group 1|Morning and evening dose of buprenorphine HCl buccal film (300 μg) + placebo capsule in one period, and then placebo buccal film + over-encapsulated ATC opioid at 50% MSE daily dose in the alternate period
123225|NCT01871285|P4|Participant Flow|MSE Dose Group 2 (BA) - ATC Opioid Then Buprenorphine (450 μg)|MSE Dose Group 2 receiving treatment sequence BA with B being ATC opioid + placebo buccal film morning and evening in period 1 and A being buprenorphine HCl buccal film (300 μg) + placebo ATC morning and evening in period 2. Each period included 1 treatment day.
123226|NCT01871285|P3|Participant Flow|MSE Dose Group 2 (AB) - Buprenorphine (450 μg) Then ATC Opioid|MSE Dose Group 2 receiving treatment sequence AB with A being buprenorphine HCl buccal film (450 μg) + placebo ATC morning and evening in period 1 and B being ATC opioid + placebo buccal film morning and evening in period 2. Each period included 1 treatment day.
123227|NCT01871285|P2|Participant Flow|MSE Dose Group 1 (BA) - ATC Opioid Then Buprenorphine (300 μg)|MSE Dose Group 1 receiving treatment sequence BA with B being ATC opioid + placebo buccal film morning and evening in period 1 and A being buprenorphine HCl buccal film (300 μg) + placebo ATC morning and evening in period 2. Each period included 1 treatment day.
123228|NCT01871285|P1|Participant Flow|MSE Dose Group 1 (AB) - Buprenorphine (300 μg) Then ATC Opioid|MSE Dose Group 1 receiving treatment sequence AB with A being buprenorphine hydrochloride (HCl) buccal film (300 μg) + placebo ATC morning and evening in period 1 and B being ATC opioid + placebo buccal film morning and evening in period 2. Each period included 1 treatment day.
123229|NCT01871285|O4|Outcome|MSE Dose Group 2 - ATC Opioid|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
123230|NCT01871285|O3|Outcome|MSE Dose Group 2 - Buprenorphine|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to buprenorphine
123231|NCT01871285|O2|Outcome|MSE Dose Group 1 - ATC Opioid|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
123232|NCT01871285|O1|Outcome|MSE Dose Group 1 - Buprenorphine|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE total daily dose (TDD); following exposure to buprenorphine
123233|NCT01871285|O4|Outcome|MSE Dose Group 2 - ATC Opioid|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
123234|NCT01871285|O3|Outcome|MSE Dose Group 2 - Buprenorphine|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to buprenorphine
123235|NCT01871285|O2|Outcome|MSE Dose Group 1 - ATC Opioid|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
123236|NCT01871285|O1|Outcome|MSE Dose Group 1 - Buprenorphine|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE total daily dose (TDD); following exposure to buprenorphine
123237|NCT01871285|O4|Outcome|MSE Dose Group 2 - ATC Opioid|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
123238|NCT01871285|O3|Outcome|MSE Dose Group 2 - Buprenorphine|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to buprenorphine
123239|NCT01871285|O2|Outcome|MSE Dose Group 1 - ATC Opioid|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
123240|NCT01871285|O1|Outcome|MSE Dose Group 1 - Buprenorphine|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE total daily dose (TDD); following exposure to buprenorphine
123241|NCT01871285|O4|Outcome|MSE Dose Group 2 - ATC Opioid|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
123242|NCT01871285|O3|Outcome|MSE Dose Group 2 - Buprenorphine|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to buprenorphine
123243|NCT01871285|O2|Outcome|MSE Dose Group 1 - ATC Opioid|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
123244|NCT01871285|O1|Outcome|MSE Dose Group 1 - Buprenorphine|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE total daily dose (TDD); following exposure to buprenorphine
123245|NCT01871285|O4|Outcome|MSE Dose Group 2 - ATC Opioid|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
123246|NCT01871285|O3|Outcome|MSE Dose Group 2 - Buprenorphine|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to buprenorphine
123247|NCT01871285|O2|Outcome|MSE Dose Group 1 - ATC Opioid|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
142863|NCT01777217|O2|Outcome|Placebo|"Drug: Placebo oral~Placebo"
123248|NCT01871285|O1|Outcome|MSE Dose Group 1 - Buprenorphine|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE total daily dose (TDD); following exposure to buprenorphine
123249|NCT01871285|E4|Reported Event|MSE Dose Group 2 - ATC Opioid|Subjects in MSE Dose Group 2 who received at least 1 dose of assigned ATC opioid in either period
123250|NCT01871285|E3|Reported Event|MSE Dose Group 2 - Buprenorphine|Subjects in MSE Dose Group 2 who received at least one 450-μg buprenorphine HCl buccal film in either period
123251|NCT01871285|E2|Reported Event|MSE Dose Group 1 - ATC Opioid|Subjects in MSE Dose Group 1 who received at least 1 dose of assigned ATC opioid in either period
123252|NCT01871285|E1|Reported Event|MSE Dose Group 1 - Buprenorphine|Subjects in MSE Dose Group 1 who received at least one 300-μg buprenorphine HCl buccal film in either period
123253|NCT01871142|B1|Baseline|Entire Study Population|All enrolled participant baseline data
123254|NCT01871142|P1|Participant Flow|Randomized Crossover Assignment|Participants will receive, in a random order, a placebo prior to exercise in normoxia, a placebo prior to exercise in hypoxia, 1000 mg of Aes-103 prior to exercise in hypoxia, and 3000 mg of Aes-103 prior to exercise in hypoxia. Each intervention is separated by a 7 day washout period.
123255|NCT01871142|O4|Outcome|3000mg Aes-103 + Hypoxia|"Number of participants receiving 3000mg Aes-103 in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% oxygen)"
123256|NCT01871142|O3|Outcome|1000mg Aes-103 + Hypoxia|"Number of participants receiving 1000mg Aes-103 in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% oxygen)"
123257|NCT01871142|O2|Outcome|Placebo + Hypoxia|"Number of participants receiving placebo in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Normoxia (21% oxygen)"
123258|NCT01871142|O1|Outcome|Placebo + Normoxia|"Number of participants receiving placebo in normoxic conditions. Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Normoxia (21% oxygen)"
123259|NCT01871142|O4|Outcome|3000mg Aes-103 + Hypoxia|"Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% oxygen)"
123260|NCT01871142|O3|Outcome|1000mg Aes-103 + Hypoxia|"Randomized crossover assignment for each participant.~Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% oxygen)"
123261|NCT01871142|O2|Outcome|Placebo + Hypoxia|"Randomized crossover assignment for each participant.~Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% Oxygen)"
123262|NCT01871142|O1|Outcome|Palcebo + Normoxia|"Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Normoxia (21% oxygen)"
123263|NCT01871142|E4|Reported Event|Hypoxia 3000 mg Aes-103 + Hypoxia|"Participants receiving 3000mg Aes-103 in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% oxygen"
123264|NCT01871142|E3|Reported Event|1000 mg Aes-103 + Hypoxia|"Participants receiving 1000mg Aes-103 in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% oxygen)"
123265|NCT01871142|E2|Reported Event|Placebo + Hypoxia|"Participants receiving placebo in Hypoxic conditions Randomized crossover assignment for each participant Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% Oxygen)"
123266|NCT01871142|E1|Reported Event|Placebo + Normoxia|"Participants receiving placebo in normoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Normoxia (21% oxygen)"
123267|NCT01871090|B3|Baseline|Total|Total of all reporting groups
123268|NCT01871090|B2|Baseline|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
123269|NCT01871090|B1|Baseline|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.~Unpaired remote monitoring transmitter"
123270|NCT01871090|P2|Participant Flow|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
123271|NCT01871090|P1|Participant Flow|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.~Unpaired remote monitoring transmitter"
123272|NCT01871090|O2|Outcome|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
123273|NCT01871090|O1|Outcome|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.~Unpaired remote monitoring transmitter"
123274|NCT01871090|O2|Outcome|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
123275|NCT01871090|O1|Outcome|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.~Unpaired remote monitoring transmitter"
123276|NCT01871090|O2|Outcome|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
123277|NCT01871090|O1|Outcome|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.~Unpaired remote monitoring transmitter"
123278|NCT01871090|E2|Reported Event|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
123279|NCT01871090|E1|Reported Event|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.~Unpaired remote monitoring transmitter"
123280|NCT01870999|B4|Baseline|Total|Total of all reporting groups
123443|NCT01870739|E1|Reported Event|Initiation Dose : Sacubitril/Valsartan (LCZ696 200mg)|Patients received LCZ696 200 mg for 2 weeks as initiation dose for 2 weeks
123281|NCT01870999|B3|Baseline|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123282|NCT01870999|B2|Baseline|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123283|NCT01870999|B1|Baseline|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123284|NCT01870999|P3|Participant Flow|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123285|NCT01870999|P2|Participant Flow|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123286|NCT01870999|P1|Participant Flow|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123287|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123288|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123289|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123290|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123291|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123292|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123293|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123294|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123295|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123296|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123297|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123298|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123299|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123300|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123444|NCT01870726|B8|Baseline|Total|Total of all reporting groups
123445|NCT01870726|B7|Baseline|400 mg BID Tab|Phase II: 400 mg INC280 (BID) tablet
123301|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123302|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123303|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123304|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123305|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123306|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123307|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123308|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123309|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123310|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123311|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123312|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123313|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123314|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123315|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123316|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123317|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123318|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123319|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123320|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123446|NCT01870726|B6|Baseline|400 mg BID Tab +80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
143000|NCT01776268|P2|Participant Flow|no Oral Priming|
123321|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123322|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123323|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123324|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123325|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123326|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123327|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123328|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123329|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123330|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123331|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123332|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123333|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123334|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123335|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123336|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123337|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123338|NCT01870999|E3|Reported Event|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123339|NCT01870999|E2|Reported Event|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123340|NCT01870999|E1|Reported Event|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
123341|NCT01870973|B3|Baseline|Total|Total of all reporting groups
123617|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
123342|NCT01870973|B2|Baseline|no Root Canal Treatment|"no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin)~no root canal treatment"
123343|NCT01870973|B1|Baseline|Root Canal Treatment|"root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin)~root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device."
123344|NCT01870973|P2|Participant Flow|no Root Canal Treatment|"no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin)~no root canal treatment"
123345|NCT01870973|P1|Participant Flow|Root Canal Treatment|"root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin)~root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device."
123346|NCT01870973|O2|Outcome|no Root Canal Treatment|"no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin)~no root canal treatment"
123347|NCT01870973|O1|Outcome|Root Canal Treatment|"root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin)~root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device."
123348|NCT01870973|E2|Reported Event|no Root Canal Treatment|"no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin)~no root canal treatment"
123349|NCT01870973|E1|Reported Event|Root Canal Treatment|"root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin)~root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device."
123350|NCT01870921|B1|Baseline|Ticargrelor|90 mg/tablet, 1 tablet bid
123351|NCT01870921|P1|Participant Flow|Ticargrelor|90 mg/tablet, 1 tablet bid
123352|NCT01870921|O1|Outcome|Ticargrelor|90 mg/tablet, 1 tablet bid
123353|NCT01870921|O1|Outcome|Ticargrelor|90 mg/tablet, 1 tablet bid
123354|NCT01870921|O1|Outcome|Ticargrelor|90 mg/tablet, 1 tablet bid
123355|NCT01870921|E1|Reported Event|Ticargrelor|90 mg/tablet, 1 tablet bid
123356|NCT01870856|B3|Baseline|Total|Total of all reporting groups
123357|NCT01870856|B2|Baseline|1-DAY ACUVUE, Stage 1|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
123358|NCT01870856|B1|Baseline|Spectacles, Stage 1|Spectacles per participant's habitual perscription worn for 2 weeks
123359|NCT01870856|P2|Participant Flow|1-DAY ACUVUE, Stage 1|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
123360|NCT01870856|P1|Participant Flow|Spectacles, Stage 1|Spectacles per participant's habitual perscription worn for 2 weeks
123361|NCT01870856|O2|Outcome|1-DAY ACUVUE, Stage 2|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
123362|NCT01870856|O1|Outcome|DAILIES TOTAL 1, Stage 2|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
123363|NCT01870856|O2|Outcome|1-DAY ACUVUE, Stage 2|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
123364|NCT01870856|O1|Outcome|DAILIES TOTAL 1, Stage 2|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
123365|NCT01870856|O2|Outcome|1-DAY ACUVUE, Stage 1|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
123366|NCT01870856|O1|Outcome|Spectacles, Stage 1|Spectacles per participant's habitual perscription worn for 2 weeks
123367|NCT01870856|E2|Reported Event|1-DAY ACUVUE, Stage 1|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
123368|NCT01870856|E1|Reported Event|Spectacles, Stage 1|Spectacles per participant's habitual perscription worn for 2 weeks
123369|NCT01870843|B1|Baseline|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
123370|NCT01870843|P1|Participant Flow|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
123371|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
123372|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
123373|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
123618|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
123374|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
123375|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
123376|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
123377|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
123378|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
123379|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
123380|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
123381|NCT01870843|E1|Reported Event|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
123382|NCT01870778|B3|Baseline|Total|Total of all reporting groups
123383|NCT01870778|B2|Baseline|Placebo|Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
123384|NCT01870778|B1|Baseline|Serelaxin (RLX030)|Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
123385|NCT01870778|P2|Participant Flow|Placebo|Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
123386|NCT01870778|P1|Participant Flow|Serelaxin (RLX030)|Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
123387|NCT01870778|O2|Outcome|Placebo|Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
123388|NCT01870778|O1|Outcome|Serelaxin (RLX030)|Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
123389|NCT01870778|O2|Outcome|Placebo|Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
123390|NCT01870778|O1|Outcome|Serelaxin (RLX030)|Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
123391|NCT01870778|O2|Outcome|Placebo|Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
123392|NCT01870778|O1|Outcome|Serelaxin (RLX030)|Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
123393|NCT01870778|O2|Outcome|Placebo|Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
123394|NCT01870778|O1|Outcome|Serelaxin (RLX030)|Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
123395|NCT01870778|O2|Outcome|Placebo|Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
123396|NCT01870778|O1|Outcome|Serelaxin (RLX030)|Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
123397|NCT01870778|O2|Outcome|Placebo|Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
123398|NCT01870778|O1|Outcome|Serelaxin (RLX030)|Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
123399|NCT01870778|O2|Outcome|Placebo|Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
123400|NCT01870778|O1|Outcome|Serelaxin (RLX030)|Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
123401|NCT01870778|O2|Outcome|Placebo|Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
123402|NCT01870778|O1|Outcome|Serelaxin (RLX030)|Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
123403|NCT01870778|O2|Outcome|Placebo|Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
123404|NCT01870778|O1|Outcome|Serelaxin (RLX030)|Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
123405|NCT01870778|O2|Outcome|Placebo|Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
123406|NCT01870778|O1|Outcome|Serelaxin (RLX030)|Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
123407|NCT01870778|E2|Reported Event|Placebo|Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
123408|NCT01870778|E1|Reported Event|Serelaxin (RLX030)|Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
123409|NCT01870739|B3|Baseline|Total|Total of all reporting groups
123410|NCT01870739|B2|Baseline|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
123411|NCT01870739|B1|Baseline|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
123412|NCT01870739|P2|Participant Flow|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
124456|NCT01864148|E4|Reported Event|BIIB033 30 mg/kg|BIIB033 30 mg/kg once every 4 weeks IV infusion
123413|NCT01870739|P1|Participant Flow|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
123414|NCT01870739|O6|Outcome|Olmesartan 40mg +/- Amlodipine|Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
123415|NCT01870739|O5|Outcome|Sacubitril/Valsartan (LCZ696 400mg) +/- Amlodipine|Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
123416|NCT01870739|O4|Outcome|Maintenance Dose: Olmesartan 40 mg|After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of olmesartan 40 mg for 10 weeks
123417|NCT01870739|O3|Outcome|Maintenance Dose: Sacubitril/Valsartan (LCZ696 400mg)|After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of LCZ696 400 mg for 10 weeks
123418|NCT01870739|O2|Outcome|Initiation Dose: Olmesartan 20mg|Patients received olmesartan 20 mg for 2 weeks as initiation dose for 2 weeks
123419|NCT01870739|O1|Outcome|Initiation Dose : Sacubitril/Valsartan (LCZ696 200mg)|Patients received LCZ696 200 mg for 2 weeks as initiation dose for 2 weeks
123420|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
123421|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
123422|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
123423|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
123424|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
123425|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
123426|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
123427|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
123428|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
123429|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
123430|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
123431|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
123432|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
123433|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
123434|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
123435|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
123436|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
123437|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
123438|NCT01870739|E6|Reported Event|Olmesartan 40mg +/- Amlodipine|Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
123439|NCT01870739|E5|Reported Event|Sacubitril/Valsartan (LCZ696 400mg) +/- Amlodipine|Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
123440|NCT01870739|E4|Reported Event|Maintenance Dose: Olmesartan 40 mg|After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of olmesartan 40 mg for 10 weeks
123441|NCT01870739|E3|Reported Event|Maintenance Dose: Sacubitril/Valsartan (LCZ696 400mg)|After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of LCZ696 400 mg for 10 weeks
123442|NCT01870739|E2|Reported Event|Initiation Dose: Olmesartan 20mg|Patients received olmesartan 20 mg for 2 weeks as initiation dose for 2 weeks
123447|NCT01870726|B5|Baseline|300 mg BID Tab +80 mg QD|Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
123448|NCT01870726|B4|Baseline|500 mg BID Cap+80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 80mg Buparlisib (QD) once daily for Phase Ib.
123449|NCT01870726|B3|Baseline|500 mg BID Cap+50 mg QD|Phase Ib: The combination of 500 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
123450|NCT01870726|B2|Baseline|400 mg BID Cap+50 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
123451|NCT01870726|B1|Baseline|200 mg BID Cap+50 mg QD|Phase Ib: The combination of 200mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib.
123452|NCT01870726|P7|Participant Flow|400 mg BID Tab|Phase II: 400 mg INC280 (BID) tablet
123453|NCT01870726|P6|Participant Flow|400 mg BID Tab +80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
123454|NCT01870726|P5|Participant Flow|300 mg BID Tab +80 mg QD|Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
123455|NCT01870726|P4|Participant Flow|500 mg BID Cap+80 mg QD|Phase Ib: The combination of 500 mg INC280 (BID) capsule and 80mg Buparlisib (QD) once daily for Phase Ib.
123456|NCT01870726|P3|Participant Flow|500 mg BID Cap+50 mg QD|Phase Ib: The combination of 500 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
123457|NCT01870726|P2|Participant Flow|400 mg BID Cap+50 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
123458|NCT01870726|P1|Participant Flow|200 mg BID Cap+50 mg QD|Phase Ib: The combination of 200mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib.
123459|NCT01870726|O1|Outcome|All Patients|The combination of INC280 (BID) and Buparlisib (QD).
123460|NCT01870726|O7|Outcome|400 mg BID Tab|Phase II: 400 mg INC280 (BID) tablet
123461|NCT01870726|O6|Outcome|400 mg BID Tab+80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 80mg Buparlisib (QD) once daily for Phase Ib.
123462|NCT01870726|O5|Outcome|300 mg BID Tab +80 mg QD|Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
123463|NCT01870726|O4|Outcome|500 mg BID Cap+80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 80mg Buparlisib (QD) once daily for Phase Ib.
123464|NCT01870726|O3|Outcome|500 mg BID Cap+50 mg QD|Phase Ib: The combination of 500 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
123465|NCT01870726|O2|Outcome|400 mg BID Cap+50 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
123466|NCT01870726|O1|Outcome|200 mg BID Cap+50 mg QD|Phase Ib: The combination of 200mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib.
123467|NCT01870726|O6|Outcome|400 mg BID Tab+80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
123468|NCT01870726|O5|Outcome|300 mg BID Tab +80 mg QD|Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
123469|NCT01870726|O4|Outcome|500 mg BID Cap+80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 80mg Buparlisib (QD) once daily for Phase Ib.
123470|NCT01870726|O3|Outcome|500 mg BID Cap+50 mg QD|Phase Ib: The combination of 500 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
123471|NCT01870726|O2|Outcome|400 mg BID Cap+50 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
123472|NCT01870726|O1|Outcome|200 mg BID Cap+50 mg QD|Phase Ib: The combination of 200mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib.
123473|NCT01870726|O6|Outcome|400 mg BID Tab+80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
123474|NCT01870726|O5|Outcome|300 mg BID Tab +80 mg QD|Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
123475|NCT01870726|O4|Outcome|500 mg BID Cap+80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 80mg Buparlisib (QD) once daily for Phase Ib.
123476|NCT01870726|O3|Outcome|500 mg BID Cap+50 mg QD|Phase Ib: The combination of 500 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
123477|NCT01870726|O2|Outcome|400 mg BID Cap+50 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
123478|NCT01870726|O1|Outcome|200 mg BID Cap+50 mg QD|Phase Ib: The combination of 200mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib.
123479|NCT01870726|O6|Outcome|400 mg BID Tab+80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
123480|NCT01870726|O5|Outcome|300 mg BID Tab +80 mg QD|Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
123481|NCT01870726|O4|Outcome|500 mg BID Cap+80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 80mg Buparlisib (QD) once daily for Phase Ib.
123482|NCT01870726|O3|Outcome|500 mg BID Cap+50 mg QD|Phase Ib: The combination of 500 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
123483|NCT01870726|O2|Outcome|400 mg BID Cap+50 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
123484|NCT01870726|O1|Outcome|200 mg BID Cap+50 mg QD|Phase Ib: The combination of 200mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib.
123485|NCT01870726|O6|Outcome|400 mg BID Tab+80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
123486|NCT01870726|O5|Outcome|300 mg BID Tab +80 mg QD|Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
123487|NCT01870726|O4|Outcome|500 mg BID Cap+80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 80mg Buparlisib (QD) once daily for Phase Ib.
123488|NCT01870726|O3|Outcome|500 mg BID Cap+50 mg QD|Phase Ib: The combination of 500 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
123489|NCT01870726|O2|Outcome|400 mg BID Cap+50 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
123490|NCT01870726|O1|Outcome|200 mg BID Cap+50 mg QD|Phase Ib: The combination of 200mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib.
123491|NCT01870726|O6|Outcome|400 mg BID Tab+80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
123492|NCT01870726|O5|Outcome|300 mg BID Tab +80 mg QD|Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
123493|NCT01870726|O4|Outcome|500 mg BID Cap+80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 80mg Buparlisib (QD) once daily for Phase Ib.
123494|NCT01870726|O3|Outcome|500 mg BID Cap+50 mg QD|Phase Ib: The combination of 500 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
123495|NCT01870726|O2|Outcome|400 mg BID Cap+50 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
123496|NCT01870726|O1|Outcome|200 mg BID Cap+50 mg QD|Phase Ib: The combination of 200mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib.
123497|NCT01870726|O6|Outcome|400 mg BID Tab+80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
123498|NCT01870726|O5|Outcome|300 mg BID Tab +80 mg QD|Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
123499|NCT01870726|O4|Outcome|500 mg BID Cap+80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 80mg Buparlisib (QD) once daily for Phase Ib.
123500|NCT01870726|O3|Outcome|500 mg BID Cap+50 mg QD|Phase Ib: The combination of 500 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
123501|NCT01870726|O2|Outcome|400 mg BID Cap+50 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
123502|NCT01870726|O1|Outcome|200 mg BID Cap+50 mg QD|Phase Ib: The combination of 200mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib.
123503|NCT01870726|O6|Outcome|400 mg BID Tab+80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
123504|NCT01870726|O5|Outcome|300 mg BID Tab +80 mg QD|Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
123505|NCT01870726|O4|Outcome|500 mg BID Cap+80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 80mg Buparlisib (QD) once daily for Phase Ib.
123506|NCT01870726|O3|Outcome|500 mg BID Cap+50 mg QD|Phase Ib: The combination of 500 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
123507|NCT01870726|O2|Outcome|400 mg BID Cap+50 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
123508|NCT01870726|O1|Outcome|200 mg BID Cap+50 mg QD|Phase Ib: The combination of 200mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib.
123509|NCT01870726|O6|Outcome|400 mg BID Tab+80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
123510|NCT01870726|O5|Outcome|300 mg BID Tab +80 mg QD|Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
123511|NCT01870726|O4|Outcome|500 mg BID Cap+80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 80mg Buparlisib (QD) once daily for Phase Ib.
123512|NCT01870726|O3|Outcome|500 mg BID Cap+50 mg QD|Phase Ib: The combination of 500 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
123513|NCT01870726|O2|Outcome|400 mg BID Cap+50 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
123514|NCT01870726|O1|Outcome|200 mg BID Cap+50 mg QD|Phase Ib: The combination of 200mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib.
123515|NCT01870726|O7|Outcome|400 mg BID Tab|Phase II: 400 mg INC280 (BID) tablet
123516|NCT01870726|O6|Outcome|400 mg BID Tab + 80 mg QD|Phase Ib: the combination of 400 mg INC280 (BID) tablet and 80 mg Buparlisib (QD) once daily
123517|NCT01870726|O5|Outcome|300 mg BID Tab + 80 mg QD|Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
123518|NCT01870726|O4|Outcome|500 mg BID Cap+80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 80mg Buparlisib (QD) once daily for Phase Ib.
123519|NCT01870726|O3|Outcome|500 mg BID Cap+50 mg QD|Phase Ib: The combination of 500 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
123520|NCT01870726|O2|Outcome|400 mg BID Cap+50 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
123521|NCT01870726|O1|Outcome|200 mg BID Cap+50 mg QD|Phase Ib: The combination of 200mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib.
123522|NCT01870726|O1|Outcome|BID + QD|The combination of INC280 (BID) and Buparlisib (QD).
123523|NCT01870726|O1|Outcome|BID Tab+Buparlisib|Phase II: INC280 (BID) as a single agent and in combination with buparlisib
123524|NCT01870726|O6|Outcome|400 mg BID Tab+80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
123525|NCT01870726|O5|Outcome|300 mg BID Tab +80 mg QD|Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib.
123526|NCT01870726|O4|Outcome|500 mg BID Cap+80 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 80mg Buparlisib (QD) once daily for Phase Ib.
123527|NCT01870726|O3|Outcome|500 mg BID Cap+50 mg QD|Phase Ib: The combination of 500 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
123528|NCT01870726|O2|Outcome|400 mg BID Cap+50 mg QD|Phase Ib: The combination of 400 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib.
123529|NCT01870726|O1|Outcome|200 mg BID Cap+50 mg QD|Phase Ib: The combination of 200mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib.
123530|NCT01870726|E10|Reported Event|All Patients (Phase II)|Phase II: All patients treated with INC280 (BID) tablet once daily in the Phase II.
123531|NCT01870726|E9|Reported Event|400 mg BID Tab|Phase II: 400mg INC280 (BID) tablet in Phase II.
123532|NCT01870726|E8|Reported Event|All Patients (Phase Ib)|Phase Ib: All Patients with the combination of INC280 (BID) and Buparlisib (QD) once daily.
123533|NCT01870726|E7|Reported Event|400 mg BID Tab+80 mg QD|Phase Ib: The combination of 400mg INC280 (BID) capsule and 80 mg Buparlisib (QD) once daily for Phase Ib.
123534|NCT01870726|E6|Reported Event|300 mg BID Tab+ 80 mg QD|Phase Ib: The combination of 300mg INC280 (BID) capsule and 80 mg Buparlisib (QD) once daily for Phase Ib.
124457|NCT01864148|E3|Reported Event|BIIB033 10 mg/kg|BIIB033 10 mg/kg once every 4 weeks IV infusion
123535|NCT01870726|E5|Reported Event|500 mg BID Cap+80 mg QD|Phase Ib: The combination of 500mg INC280 (BID) capsule and 80 mg Buparlisib (QD) once daily for Phase Ib.
123536|NCT01870726|E4|Reported Event|500 mg BID Cap+50 mg QD|Phase Ib: The combination of 500mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib.
123537|NCT01870726|E3|Reported Event|400 mg BID Cap + 50 mg QD|Phase Ib: The combination of 400mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib.
123538|NCT01870726|E2|Reported Event|200 mg BID Cap+50 mg QD|Phase Ib: The combination of 200mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib.
123539|NCT01870726|E1|Reported Event|INC280 200 mg BID Tab|Phase II: 200mg INC280 (BID) tablet in Phase II. A patient never received the intended PhII dose as planned (400 mg BID) but is resented as a separate group for safety.
123540|NCT01870596|B3|Baseline|Total|Total of all reporting groups
123541|NCT01870596|B2|Baseline|Arm B (Cytarabine)|"Patients receive cytarabine as in Arm A.~Cytarabine: Given IV~Laboratory Biomarker Analysis: Correlative studies"
123542|NCT01870596|B1|Baseline|Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)|"Patients receive cytarabine IV continuously over 72 hours on days 1-3 and 10-12 and Chk1 inhibitor SCH 900776 IV over 30 minutes on days 2, 3, 11, and 12.~Cytarabine: Given IV~CHK1 Inhibitor SCH 900776: Given IV~Laboratory Biomarker Analysis: Correlative studies"
123543|NCT01870596|P2|Participant Flow|Arm B (Cytarabine)|"Patients receive cytarabine as in Arm A.~Cytarabine: Given IV~Laboratory Biomarker Analysis: Correlative studies"
123544|NCT01870596|P1|Participant Flow|Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)|"Patients receive cytarabine IV continuously over 72 hours on days 1-3 and 10-12 and Chk1 inhibitor SCH 900776 IV over 30 minutes on days 2, 3, 11, and 12.~Cytarabine: Given IV~CHK1 Inhibitor SCH 900776: Given IV~Laboratory Biomarker Analysis: Correlative studies"
123545|NCT01870596|O2|Outcome|Arm B (Cytarabine)|"Patients receive cytarabine as in Arm A.~Cytarabine: Given IV~Laboratory Biomarker Analysis: Correlative studies"
123546|NCT01870596|O1|Outcome|Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)|"Patients receive cytarabine IV continuously over 72 hours on days 1-3 and 10-12 and Chk1 inhibitor SCH 900776 IV over 30 minutes on days 2, 3, 11, and 12.~Cytarabine: Given IV~CHK1 Inhibitor SCH 900776: Given IV~Laboratory Biomarker Analysis: Correlative studies"
123547|NCT01870596|E2|Reported Event|Arm B (Cytarabine)|"Patients receive cytarabine as in Arm A.~Cytarabine: Given IV~Laboratory Biomarker Analysis: Correlative studies"
123548|NCT01870596|E1|Reported Event|Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)|"Patients receive cytarabine IV continuously over 72 hours on days 1-3 and 10-12 and Chk1 inhibitor SCH 900776 IV over 30 minutes on days 2, 3, 11, and 12.~Cytarabine: Given IV~CHK1 Inhibitor SCH 900776: Given IV~Laboratory Biomarker Analysis: Correlative studies"
123549|NCT01870583|B4|Baseline|Total|Total of all reporting groups
123550|NCT01870583|B3|Baseline|Iodine Povidone|"Iodine povidone based skin preparation solution applied to skin prior to cesarean delivery~Iodine povidone: Iodine skin preparation solution prior to cesarean delivery"
123551|NCT01870583|B2|Baseline|Chlorhexidine|"Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery~Chlorhexidine: Chlorhexidine skin preparation solution prior to cesarean delivery"
123552|NCT01870583|B1|Baseline|Combination Iodine and Chlorhexidine|"The combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery.~Combination iodine and chlorhexidine: Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery"
123553|NCT01870583|P3|Participant Flow|Iodine Povidone|"Iodine povidone based skin preparation solution applied to skin prior to cesarean delivery~Iodine povidone: Iodine skin preparation solution prior to cesarean delivery"
123554|NCT01870583|P2|Participant Flow|Chlorhexidine|"Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery~Chlorhexidine: Chlorhexidine skin preparation solution prior to cesarean delivery"
123555|NCT01870583|P1|Participant Flow|Combination Iodine and Chlorhexidine|"The combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery.~Combination iodine and chlorhexidine: Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery"
123556|NCT01870583|O3|Outcome|Iodine Povidone|"Iodine povidone based skin preparation solution applied to skin prior to cesarean delivery~Iodine povidone: Iodine skin preparation solution prior to cesarean delivery"
123557|NCT01870583|O2|Outcome|Chlorhexidine|"Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery~Chlorhexidine: Chlorhexidine skin preparation solution prior to cesarean delivery"
123558|NCT01870583|O1|Outcome|Combination Iodine and Chlorhexidine|"The combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery.~Combination iodine and chlorhexidine: Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery"
123559|NCT01870583|E3|Reported Event|Iodine Povidone|"Iodine povidone based skin preparation solution applied to skin prior to cesarean delivery~Iodine povidone: Iodine skin preparation solution prior to cesarean delivery"
123560|NCT01870583|E2|Reported Event|Chlorhexidine|"Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery~Chlorhexidine: Chlorhexidine skin preparation solution prior to cesarean delivery"
123561|NCT01870583|E1|Reported Event|Combination Iodine and Chlorhexidine|"The combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery.~Combination iodine and chlorhexidine: Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery"
123562|NCT01870388|B3|Baseline|Total|Total of all reporting groups
123563|NCT01870388|B2|Baseline|Baricitinib (Moderate Hepatic Impairment)|Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with moderate hepatic impairment as classified by Child-Pugh B.
123564|NCT01870388|B1|Baseline|Baricitinib (Healthy Participants)|Group 1: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with normal hepatic function.
123565|NCT01870388|P2|Participant Flow|Baricitinib (Moderate Hepatic Impairment)|Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with moderate hepatic impairment as classified by Child-Pugh B.
124458|NCT01864148|E2|Reported Event|BIIB033 3 mg/kg|BIIB033 3 mg/kg once every 4 weeks IV infusion
123566|NCT01870388|P1|Participant Flow|Baricitinib (Healthy Participants)|Group 1: A single 4-milligram (mg) dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with normal hepatic function.
123567|NCT01870388|O2|Outcome|Baricitinib (Moderate Hepatic Impairment)|Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with moderate hepatic impairment as classified by Child-Pugh B.
123568|NCT01870388|O1|Outcome|Baricitinib (Healthy Participants)|Group 1: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with normal hepatic function.
123569|NCT01870388|O2|Outcome|Baricitinib (Moderate Hepatic Impairment)|Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally to participants with moderate hepatic impairment as classified by Child-Pugh B.
123570|NCT01870388|O1|Outcome|Baricitinib (Healthy Participants)|Group 1: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally to participants with normal hepatic function.
123571|NCT01870388|E2|Reported Event|Baricitinib (Moderate Hepatic Impairment)|Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with moderate hepatic impairment as classified by Child-Pugh B.
123572|NCT01870388|E1|Reported Event|Baricitinib (Healthy Participants)|Group 1: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with normal hepatic function.
123573|NCT01870076|B5|Baseline|Total|Total of all reporting groups
123574|NCT01870076|B4|Baseline|Control, No Presence|No Presence in the room one hour prior to bed.
123575|NCT01870076|B3|Baseline|Control, Presence|"Control, Presence Intervention in the room one hour prior to bed.~Control, Presence"
123576|NCT01870076|B2|Baseline|Healing Touch Sham|"Healing Touch Sham provided one hour prior to bed.~Healing Touch, Sham"
123577|NCT01870076|B1|Baseline|Healing Touch Intervention|"Healing Touch performed one hour prior to bed.~Healing Touch"
123578|NCT01870076|P4|Participant Flow|Control, No Presence|No Presence in the room one hour prior to bed.
123579|NCT01870076|P3|Participant Flow|Control, Presence|"Control, Presence Intervention in the room one hour prior to bed.~Control, Presence"
123580|NCT01870076|P2|Participant Flow|Healing Touch Sham|"Healing Touch Sham provided one hour prior to bed.~Healing Touch, Sham"
123581|NCT01870076|P1|Participant Flow|Healing Touch Intervention|"Healing Touch performed one hour prior to bed.~Healing Touch"
123582|NCT01870076|O4|Outcome|Control, No Presence|No Presence in the room one hour prior to bed.
123583|NCT01870076|O3|Outcome|Control, Presence|"Control, Presence Intervention in the room one hour prior to bed.~Control, Presence"
123584|NCT01870076|O2|Outcome|Healing Touch Sham|"Healing Touch Sham provided one hour prior to bed.~Healing Touch, Sham"
123585|NCT01870076|O1|Outcome|Healing Touch Intervention|"Healing Touch performed one hour prior to bed.~Healing Touch"
123586|NCT01870076|O4|Outcome|Control, No Presence|No Presence in the room one hour prior to bed.
123587|NCT01870076|O3|Outcome|Control, Presence|"Control, Presence Intervention in the room one hour prior to bed.~Control, Presence"
123588|NCT01870076|O2|Outcome|Healing Touch Sham|"Healing Touch Sham provided one hour prior to bed.~Healing Touch, Sham"
123589|NCT01870076|O1|Outcome|Healing Touch Intervention|"Healing Touch performed one hour prior to bed.~Healing Touch"
123590|NCT01870076|E4|Reported Event|Control, No Presence|No Presence in the room one hour prior to bed.
123591|NCT01870076|E3|Reported Event|Control, Presence|"Control, Presence Intervention in the room one hour prior to bed.~Control, Presence"
123592|NCT01870076|E2|Reported Event|Healing Touch Sham|"Healing Touch Sham provided one hour prior to bed.~Healing Touch, Sham"
123593|NCT01870076|E1|Reported Event|Healing Touch Intervention|"Healing Touch performed one hour prior to bed.~Healing Touch"
123594|NCT01869959|B5|Baseline|Total|Total of all reporting groups
123595|NCT01869959|B4|Baseline|Placebo|Placebo-matching LY2405319 injected subcutaneously (SC) once daily for 28 days.
123596|NCT01869959|B3|Baseline|20 mg LY2405319|20 mg LY2405319 injected SC once daily for 28 days.
123597|NCT01869959|B2|Baseline|10 mg LY2405319|10 mg LY2405319 injected SC once daily for 28 days.
123598|NCT01869959|B1|Baseline|3 mg LY2405319|3 mg LY2405319 injected SC once daily for 28 days.
123599|NCT01869959|P5|Participant Flow|All Randomized Participants|All participants randomized in the study.
123600|NCT01869959|P4|Participant Flow|Placebo|Placebo-matching LY2405319 injected subcutaneously (SC) once daily for 28 days.
123601|NCT01869959|P3|Participant Flow|20 mg LY2405319|20 mg LY2405319 injected SC once daily for 28 days.
123602|NCT01869959|P2|Participant Flow|10 mg LY2405319|10 mg LY2405319 injected SC once daily for 28 days.
123603|NCT01869959|P1|Participant Flow|3 mg LY2405319|3 milligrams (mg) LY2405319 injected SC once daily for 28 days.
123604|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
123605|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
123606|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
123607|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
123608|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
123609|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
123610|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
123611|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
123612|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
123613|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
123614|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
123615|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
123616|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
123619|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
123620|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
123621|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
123622|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
123623|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
123624|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
123625|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
123626|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
123627|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
123628|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
123629|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
123630|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
123631|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
123632|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
123633|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
123634|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
123635|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
123636|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
123637|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
123638|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
123639|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
123640|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
123641|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
123642|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
123643|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
123644|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
123645|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
123646|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
123647|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
123648|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
123649|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
123650|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
123651|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
123652|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
123653|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
123654|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
123655|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
123656|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
123657|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
123658|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
123659|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
123660|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
123661|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
123662|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
123663|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
123664|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
123665|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
123666|NCT01869959|E4|Reported Event|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
123667|NCT01869959|E3|Reported Event|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
123668|NCT01869959|E2|Reported Event|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
123669|NCT01869959|E1|Reported Event|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
123670|NCT01869699|B3|Baseline|Total|Total of all reporting groups
123671|NCT01869699|B2|Baseline|Acetaminophen|"Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes~Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes"
123672|NCT01869699|B1|Baseline|Normal Saline Placebo|"Normal saline 100 mLs intravenous, administered over 15 minutes~Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes"
123673|NCT01869699|P2|Participant Flow|Acetaminophen|"Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes~Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes"
123674|NCT01869699|P1|Participant Flow|Normal Saline Placebo|"Normal saline 100 mLs intravenous, administered over 15 minutes~Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes"
123675|NCT01869699|O2|Outcome|Acetaminophen|"Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes~Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes"
123676|NCT01869699|O1|Outcome|Normal Saline Placebo|"Normal saline 100 mLs intravenous, administered over 15 minutes~Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes"
123677|NCT01869699|O2|Outcome|Acetaminophen|"Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes~Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes"
123678|NCT01869699|O1|Outcome|Normal Saline Placebo|"Normal saline 100 mLs intravenous, administered over 15 minutes~Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes"
123679|NCT01869699|O2|Outcome|Acetaminophen|"Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes~Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes"
123680|NCT01869699|O1|Outcome|Normal Saline Placebo|"Normal saline 100 mLs intravenous, administered over 15 minutes~Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes"
123681|NCT01869699|O2|Outcome|Acetaminophen|"Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes~Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes"
123682|NCT01869699|O1|Outcome|Normal Saline Placebo|"Normal saline 100 mLs intravenous, administered over 15 minutes~Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes"
123683|NCT01869699|O2|Outcome|Acetaminophen|"Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes~Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes"
123684|NCT01869699|O1|Outcome|Normal Saline Placebo|"Normal saline 100 mLs intravenous, administered over 15 minutes~Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes"
123685|NCT01869699|O2|Outcome|Acetaminophen|"Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes~Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes"
123686|NCT01869699|O1|Outcome|Normal Saline Placebo|"Normal saline 100 mLs intravenous, administered over 15 minutes~Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes"
123687|NCT01869699|O2|Outcome|Acetaminophen|"Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes~Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes"
123688|NCT01869699|O1|Outcome|Normal Saline Placebo|"Normal saline 100 mLs intravenous, administered over 15 minutes~Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes"
123689|NCT01869699|E2|Reported Event|Acetaminophen|"Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes~Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes"
123690|NCT01869699|E1|Reported Event|Normal Saline Placebo|"Normal saline 100 mLs intravenous, administered over 15 minutes~Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes"
123691|NCT01869686|B1|Baseline|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
123692|NCT01869686|P1|Participant Flow|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
123693|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
123694|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
123695|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
123696|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
123697|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
123698|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
123699|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
123700|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
123701|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
123702|NCT01869686|E1|Reported Event|Denosumab 60 mg SC|
123703|NCT01869647|B4|Baseline|Total|Total of all reporting groups
123704|NCT01869647|B3|Baseline|"Low Likelihood of Stone Group"|"In the low likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.~low likelihood of stone group: No imaging"
123705|NCT01869647|B2|Baseline|"Moderate Likelihood of Stone Group"|"Subjects in the moderate likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.~moderate likelihood of stone group: Regular CT or Low Dose CT scan"
123706|NCT01869647|B1|Baseline|"High Likelihood of Stone Group"|"Subjects in the high likelihood of stone group will be eligible to get either ULDCT or expectant management. The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.~high likelihood of stone group: Ultra low dose CT scan"
123725|NCT01869478|O1|Outcome|Intravenous Thrombolysis|0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
123707|NCT01869647|P3|Participant Flow|"Low Likelihood of Stone Group"|"In the low likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.~low likelihood of stone group: No imaging"
123708|NCT01869647|P2|Participant Flow|"Moderate Likelihood of Stone Group"|"Subjects in the moderate likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.~moderate likelihood of stone group: Regular CT or Low Dose CT scan"
123709|NCT01869647|P1|Participant Flow|"High Likelihood of Stone Group"|"Subjects in the high likelihood of stone group will be eligible to get either ULDCT or expectant management. The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.~high likelihood of stone group: Ultra low dose CT scan"
123710|NCT01869647|O3|Outcome|"Low Likelihood of Stone Group"|"In the low likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.~low likelihood of stone group: No imaging"
123711|NCT01869647|O2|Outcome|"Moderate Likelihood of Stone Group"|"Subjects in the moderate likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.~moderate likelihood of stone group: Regular CT or Low Dose CT scan"
123712|NCT01869647|O1|Outcome|"High Likelihood of Stone Group"|"Subjects in the high likelihood of stone group will be eligible to get either ULDCT or expectant management. The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.~high likelihood of stone group: Ultra low dose CT scan"
123713|NCT01869647|O3|Outcome|"Low Likelihood of Stone Group"|"In the low likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.~low likelihood of stone group: No imaging"
123714|NCT01869647|O2|Outcome|"Moderate Likelihood of Stone Group"|"Subjects in the moderate likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.~moderate likelihood of stone group: Regular CT or Low Dose CT scan"
123715|NCT01869647|O1|Outcome|"High Likelihood of Stone Group"|"Subjects in the high likelihood of stone group will be eligible to get either ULDCT or expectant management. The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.~high likelihood of stone group: Ultra low dose CT scan"
123716|NCT01869647|E3|Reported Event|"Low Likelihood of Stone Group"|"In the low likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.~low likelihood of stone group: No imaging"
123717|NCT01869647|E2|Reported Event|"Moderate Likelihood of Stone Group"|"Subjects in the moderate likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.~moderate likelihood of stone group: Regular CT or Low Dose CT scan"
123718|NCT01869647|E1|Reported Event|"High Likelihood of Stone Group"|"Subjects in the high likelihood of stone group will be eligible to get either ULDCT or expectant management. The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.~high likelihood of stone group: Ultra low dose CT scan"
123719|NCT01869478|B3|Baseline|Total|Total of all reporting groups
123720|NCT01869478|B2|Baseline|Endovascular Arterial Reperfusion|Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
123721|NCT01869478|B1|Baseline|Intravenous Thrombolysis|0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
123722|NCT01869478|P2|Participant Flow|Endovascular Arterial Reperfusion|Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
123723|NCT01869478|P1|Participant Flow|Intravenous Thrombolysis|0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
123724|NCT01869478|O2|Outcome|Endovascular Arterial Reperfusion|Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
126428|NCT01854658|O4|Outcome|Placebo MDI|Inhaled placebo administered as two puffs BID
123726|NCT01869478|O2|Outcome|Endovascular Arterial Reperfusion|Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
123727|NCT01869478|O1|Outcome|Intravenous Thrombolysis|0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
123728|NCT01869478|E2|Reported Event|Endovascular Arterial Reperfusion|Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
123729|NCT01869478|E1|Reported Event|Intravenous Thrombolysis|0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
123730|NCT01869439|B1|Baseline|External Wounds Measured for Length by Width Using a Ruler|"This is a single arm study of subjects who have an external wound that is currently measured for length and width using a ruler. A study subject may have up to 3 qualifying external wounds.~gold standard LxW manual ruler measurement technique: The LxW is measured by measuring the longest length (head to toe) times the widest width (perpendicular to the length).~LxW measurement technique: This software measurement technique measures the external wound LxW by the longest length (head to toe) times the widest width (perpendicular to the longest length).~Visual External Wound Trace: This software measurement enables the user to trace the perimeter edge of the wound's visual image.~External Wound Trace Overlay: This software measurement utilizes the visual external wound trace and overlaying it onto the thermal wound site. From the thermal overlay, data such as the differences in the thermal intensities (gradiency), mean, and the mode of the thermal wound bed can be measured."
123731|NCT01869439|P1|Participant Flow|Wounds Measures of LxW Ruler & Software LxW, Area & Perimeter|"This is a single arm study of subjects who have an external wound that is currently measured for length and width using a ruler. A study subject may have up to 3 qualifying external wounds.~gold standard LxW manual ruler measurement technique: Currently, the gold standard LxW manual ruler measurement technique is used for measuring the area of an external wound. The LxW is measured by measuring the longest length (head to toe) times the widest width (perpendicular to the length).~WMMS ImageReview software's LxW measurement technique: This software measurement technique is part of tthe WMMS and also measures the external wound LxW by the longest length (head to toe) times the widest width (perpendicular to the longest length).~WMMS ImageReview software's Visual External Wound Trace: This is a measurement technique of the ImageReview software that enables the user to trace the perimeter edge of the wound's visual image."
123732|NCT01869439|O1|Outcome|Wounds Measured for Length by Width Using a Ruler and Software|"This is a single arm study of subjects who have an external wound that is currently measured for length and width using a ruler. A study subject may have up to 3 qualifying external wounds.~The gold standard LxW manual ruler measurement technique: Currently, the gold standard LxW manual ruler measurement technique is used for measuring the area of an external wound. The LxW is measured by measuring the longest length (head to toe) times the widest width (perpendicular to the length).~Software LxW measurement technique: This software measurement technique is part of tthe WMMS and also measures the external wound LxW by the longest length (head to toe) times the widest width (perpendicular to the longest length).~Software's Visual External Wound Trace: This is a measurement technique of the ImageReview software that enables the user to trace the perimeter edge of the wound's visual image."
123733|NCT01869439|E1|Reported Event|External Wounds Measured for Length by Width Using a Ruler|"This is a single arm study of subjects who have an external wound that is currently measured for length and width using a ruler. A study subject may have up to 3 qualifying external wounds.~gold standard LxW manual ruler measurement technique: Currently, the gold standard LxW manual ruler measurement technique is used for measuring the area of an external wound. The LxW is measured by measuring the longest length (head to toe) times the widest width (perpendicular to the length).~WMMS ImageReview software's LxW measurement technique: This software measurement technique is part of tthe WMMS and also measures the external wound LxW by the longest length (head to toe) times the widest width (perpendicular to the longest length).~WMMS ImageReview software's Visual External Wound Trace: This is a measurement technique of the ImageReview software that enables the user to trace the perimeter edge of the wound's visual image."
123734|NCT01869348|B3|Baseline|Total|Total of all reporting groups
123735|NCT01869348|B2|Baseline|Monitor Intervention|"This arm will receive the monitor intervention, including provision of a wristband activity monitor and mini-tablet as well as weekly counseling phone calls~Monitor intervention: Investigators will lend each participant 1 Jawbone Up activity monitor and 1 mini tablet device. Participants will receive weekly brief phone calls with counseling related to self-efficacy and self-regulation. The monitors will be programmed to provide idle alerts that vibrate when participants have reached a cut point for a bout of sedentary behavior (e.g., 30 minutes). Participants will monitor their progress using an app on the tablet that provides graphical feedback on physical activity and sedentary behavior."
123736|NCT01869348|B1|Baseline|Wait List Control|This group will receive no intervention until after data collection for the randomized trial is completed. Then, they will receive the monitor intervention.
123737|NCT01869348|P2|Participant Flow|Monitor Intervention|"This arm will receive the monitor intervention, including provision of a wristband activity monitor and mini-tablet as well as weekly counseling phone calls~Monitor intervention: Investigators will lend each participant 1 Jawbone Up activity monitor and 1 mini tablet device. Participants will receive weekly brief phone calls with counseling related to self-efficacy and self-regulation. The monitors will be programmed to provide idle alerts that vibrate when participants have reached a cut point for a bout of sedentary behavior (e.g., 30 minutes). Participants will monitor their progress using an app on the tablet that provides graphical feedback on physical activity and sedentary behavior."
123738|NCT01869348|P1|Participant Flow|Wait List Control|This group will receive no intervention until after data collection for the randomized trial is completed. Then, they will receive the monitor intervention.
123765|NCT01869075|E3|Reported Event|MGS - Knowledge Translation Toolkit|"Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
123766|NCT01869075|E2|Reported Event|AMI - Usual Care|Usual care as provided at the hospital
123797|NCT01868789|P2|Participant Flow|Weightbearing CT (Control Group)|"Weightbearing CT scan of normal foot~Weightbearing CT"
123739|NCT01869348|O2|Outcome|Monitor Intervention|"This arm will receive the monitor intervention, including provision of a wristband activity monitor and mini-tablet as well as weekly counseling phone calls~Monitor intervention: Investigators will lend each participant 1 Jawbone Up activity monitor and 1 mini tablet device. Participants will receive weekly brief phone calls with counseling related to self-efficacy and self-regulation. The monitors will be programmed to provide idle alerts that vibrate when participants have reached a cut point for a bout of sedentary behavior (e.g., 30 minutes). Participants will monitor their progress using an app on the tablet that provides graphical feedback on physical activity and sedentary behavior."
123740|NCT01869348|O1|Outcome|Wait List Control|This group will receive no intervention until after data collection for the randomized trial is completed. Then, they will receive the monitor intervention.
123741|NCT01869348|E2|Reported Event|Monitor Intervention|"This arm will receive the monitor intervention, including provision of a wristband activity monitor and mini-tablet as well as weekly counseling phone calls~Monitor intervention: Investigators will lend each participant 1 Jawbone Up activity monitor and 1 mini tablet device. Participants will receive weekly brief phone calls with counseling related to self-efficacy and self-regulation. The monitors will be programmed to provide idle alerts that vibrate when participants have reached a cut point for a bout of sedentary behavior (e.g., 30 minutes). Participants will monitor their progress using an app on the tablet that provides graphical feedback on physical activity and sedentary behavior."
123742|NCT01869348|E1|Reported Event|Wait List Control|This group will receive no intervention until after data collection for the randomized trial is completed. Then, they will receive the monitor intervention.
123743|NCT01869075|B7|Baseline|Total|Total of all reporting groups
123744|NCT01869075|B6|Baseline|HFS - Usual Care|Usual Care as provided at the hospital.
123745|NCT01869075|B5|Baseline|HFS - Knowledge Translation Toolkit|"Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
123746|NCT01869075|B4|Baseline|MGS - Usual Care|Usual Care as provided at the hospital.
123747|NCT01869075|B3|Baseline|MGS - Knowledge Translation Toolkit|"Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
123748|NCT01869075|B2|Baseline|AMI - Usual Care|Usual care as provided at the hospital.
123749|NCT01869075|B1|Baseline|AMI - Knowledge Translation Toolkit|"AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
123750|NCT01869075|P6|Participant Flow|HFS - Usual Care|Usual care provided at the hospital
123751|NCT01869075|P5|Participant Flow|HFS - Knowledge Translation Toolkit|"Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
123752|NCT01869075|P4|Participant Flow|MGS - Usual Care|Usual care provided at the hospital
123753|NCT01869075|P3|Participant Flow|MGS - Knowledge Translation Toolkit|"Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
123754|NCT01869075|P2|Participant Flow|AMI - Usual Care|Usual care provided at the hospital
123755|NCT01869075|P1|Participant Flow|AMI - Knowledge Translation Toolkit|"AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
123756|NCT01869075|O6|Outcome|HFS - Usual Care|Usual Care as provided at the hospital
123757|NCT01869075|O5|Outcome|HFS - Knowledge Translation Toolkit|"Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
123758|NCT01869075|O4|Outcome|MGS - Usual Care|Usual Care as provided at the hospital
123759|NCT01869075|O3|Outcome|MGS - Knowledge Translation Toolkit|"Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
123760|NCT01869075|O2|Outcome|AMI - Usual Care|Usual care as provided at the hospital
123761|NCT01869075|O1|Outcome|AMI - Knowledge Translation Toolkit|"AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
123762|NCT01869075|E6|Reported Event|HFS - Usual Care|Usual Care as provided at the hospital
123763|NCT01869075|E5|Reported Event|HFS - Knowledge Translation Toolkit|"Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
123764|NCT01869075|E4|Reported Event|MGS - Usual Care|Usual Care as provided at the hospital
123795|NCT01868789|B2|Baseline|Weightbearing CT (Control Group)|"Weightbearing CT scan of normal foot~Weightbearing CT"
123796|NCT01868789|B1|Baseline|Weightbearing CT (AAFD Group)|"Weightbearing CT scan of affected foot~Weightbearing CT"
123767|NCT01869075|E1|Reported Event|AMI - Knowledge Translation Toolkit|"AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
123768|NCT01868997|B3|Baseline|Total|Total of all reporting groups
123769|NCT01868997|B2|Baseline|Teprotumumab|Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants started treatment at a dose of 10 mg/kg. At Week 3, the dose was escalated to 20 mg/kg and kept constant for the remainder of the study.
123770|NCT01868997|B1|Baseline|Placebo|A placebo infusion (normal saline) was administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions.
123771|NCT01868997|P2|Participant Flow|Teprotumumab|Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants started treatment at a dose of 10 mg/kg. At Week 3, the dose was escalated to 20 mg/kg and kept constant for the remainder of the study.
123772|NCT01868997|P1|Participant Flow|Placebo|A placebo infusion (normal saline) was administered once every 3 weeks (q3W) by intravenous (IV) infusion over a period of 24 weeks for a total of 8 infusions.
123773|NCT01868997|O2|Outcome|Teprotumumab|Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants started treatment at a dose of 10 mg/kg. At Week 3, the dose was escalated to 20 mg/kg and kept constant for the remainder of the study.
123774|NCT01868997|O1|Outcome|Placebo|A placebo infusion (normal saline) was administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions.
123775|NCT01868997|O2|Outcome|Teprotumumab|Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants started treatment at a dose of 10 mg/kg. At Week 3, the dose was escalated to 20 mg/kg and kept constant for the remainder of the study.
123776|NCT01868997|O1|Outcome|Placebo|A placebo infusion (normal saline) was administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions.
123777|NCT01868997|O2|Outcome|Teprotumumab|Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants started treatment at a dose of 10 mg/kg. At Week 3, the dose was escalated to 20 mg/kg and kept constant for the remainder of the study.
123778|NCT01868997|O1|Outcome|Placebo|A placebo infusion (normal saline) was administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions.
123779|NCT01868997|O2|Outcome|Teprotumumab|Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants started treatment at a dose of 10 mg/kg. At Week 3, the dose was escalated to 20 mg/kg and kept constant for the remainder of the study.
123780|NCT01868997|O1|Outcome|Placebo|A placebo infusion (normal saline) was administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions.
123781|NCT01868997|O2|Outcome|Teprotumumab|Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants started treatment at a dose of 10 mg/kg. At Week 3, the dose was escalated to 20 mg/kg and kept constant for the remainder of the study.
123782|NCT01868997|O1|Outcome|Placebo|A placebo infusion (normal saline) was administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions.
123783|NCT01868997|O2|Outcome|Teprotumumab|Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants started treatment at a dose of 10 mg/kg. At Week 3, the dose was escalated to 20 mg/kg and kept constant for the remainder of the study.
123784|NCT01868997|O1|Outcome|Placebo|A placebo infusion (normal saline) was administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions.
123785|NCT01868997|E2|Reported Event|Safety Population: Teprotumumab|"Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants started treatment at a dose of 10 mg/kg. At Week 3, the dose was escalated to 20 mg/kg and kept constant for the remainder of the study.~Safety Population: participants who received at least 1 dose of study treatment, grouped by treatment actually received."
123786|NCT01868997|E1|Reported Event|Safety Population: Placebo|"A placebo infusion (normal saline) was administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions.~Safety Population: participants who received at least 1 dose of study treatment, grouped by treatment actually received."
123787|NCT01868893|B1|Baseline|Obinutuzumab + Chlorambucil|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
123788|NCT01868893|P1|Participant Flow|Obinutuzumab + Chlorambucil|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
123789|NCT01868893|O1|Outcome|Obinutuzumab + Chlorambucil|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
123790|NCT01868893|O1|Outcome|Obinutuzumab + Chlorambucil|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
123791|NCT01868893|O2|Outcome|Chlorambucil|Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6.
123792|NCT01868893|O1|Outcome|Obinutuzumab|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6.
123793|NCT01868893|E1|Reported Event|Obinutuzumab + Chlorambucil|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
123794|NCT01868789|B3|Baseline|Total|Total of all reporting groups
123798|NCT01868789|P1|Participant Flow|Weightbearing CT (AAFD Group)|"Weightbearing CT scan of affected foot~Weightbearing CT"
123799|NCT01868789|O2|Outcome|Weightbearing CT (Control Group)|"Weightbearing CT scan of normal foot~Weightbearing CT"
123800|NCT01868789|O1|Outcome|Weightbearing CT (AAFD Group)|"Weightbearing CT scan of affected foot~Weightbearing CT"
123801|NCT01868789|O2|Outcome|Weightbearing CT (Control Group)|"Weightbearing CT scan of normal foot~Weightbearing CT"
123802|NCT01868789|O1|Outcome|Weightbearing CT (AAFD Group)|"Weightbearing CT scan of affected foot~Weightbearing CT"
123803|NCT01868789|E2|Reported Event|Weightbearing CT (Control Group)|"Weightbearing CT scan of normal foot~Weightbearing CT"
123804|NCT01868789|E1|Reported Event|Weightbearing CT (AAFD Group)|"Weightbearing CT scan of affected foot~Weightbearing CT"
123805|NCT01868776|B3|Baseline|Total|Total of all reporting groups
123806|NCT01868776|B2|Baseline|Nonbuffered|nonbuffered lidocaine
123807|NCT01868776|B1|Baseline|Buffered|buffered lidocaine
123808|NCT01868776|P2|Participant Flow|Nonbuffered|nonbuffered lidocaine
123809|NCT01868776|P1|Participant Flow|Buffered|buffered lidocaine
123810|NCT01868776|O2|Outcome|Nonbuffered Lidocaine|"4% lidocaine with 1:100,000 epinephrine~nonbuffered lidocaine"
123811|NCT01868776|O1|Outcome|Buffered Lidocaine|"4% lidocaine with 1:100,000 epinephrine/0.18 mEq/mL sodium bicarbonate.~buffered lidocaine"
123812|NCT01868776|E2|Reported Event|Nonbuffered|nonbuffered lidocaine
123813|NCT01868776|E1|Reported Event|Buffered|buffered lidocaine
123814|NCT01868633|B3|Baseline|Total|Total of all reporting groups
123815|NCT01868633|B2|Baseline|Placebo Injection and Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively~Placebo"
123816|NCT01868633|B1|Baseline|Dexamethasone & Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively~Dexamethasone"
123817|NCT01868633|P2|Participant Flow|Placebo Injection and Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively~Placebo"
123818|NCT01868633|P1|Participant Flow|Dexamethasone & Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively~Dexamethasone"
123819|NCT01868633|O2|Outcome|Placebo Injection and Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively~Placebo"
123820|NCT01868633|O1|Outcome|Dexamethasone & Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively~Dexamethasone"
123821|NCT01868633|O2|Outcome|Placebo Injection and Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively~Placebo"
123822|NCT01868633|O1|Outcome|Dexamethasone & Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively~Dexamethasone"
123823|NCT01868633|O2|Outcome|Placebo Injection and Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively~Placebo"
123824|NCT01868633|O1|Outcome|Dexamethasone & Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively~Dexamethasone"
123825|NCT01868633|O2|Outcome|Placebo Injection and Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively~Placebo"
123826|NCT01868633|O1|Outcome|Dexamethasone & Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively~Dexamethasone"
123827|NCT01868633|O2|Outcome|Placebo Injection and Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively~Placebo"
123828|NCT01868633|O1|Outcome|Dexamethasone & Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively~Dexamethasone"
123829|NCT01868633|E2|Reported Event|Placebo Injection and Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively~Placebo"
123830|NCT01868633|E1|Reported Event|Dexamethasone & Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively~Dexamethasone"
123831|NCT01868542|B3|Baseline|Total|Total of all reporting groups
123832|NCT01868542|B2|Baseline|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
123864|NCT01868334|B1|Baseline|Pittsburgh Intervention|"Practices: Represents 10 clinical practices engaged in active intervention in Year 1.~Patients: Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013 (Tdap, pneumococcal) and 8/1/2012 to 1/31/2013 (influenza), Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 (Tdao, pneumococcal) and 8/1/2013 to 1/31/2014 (influenza) and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015 (Tdap, pneumococcal) and 8/1/2014 to 1/31/2015 (influenza)."
123833|NCT01868542|B1|Baseline|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
123834|NCT01868542|P2|Participant Flow|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
123835|NCT01868542|P1|Participant Flow|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
123836|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
123837|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
123838|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
123839|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
123840|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
123889|NCT01868334|O4|Outcome|Year 1 RCCT Pittsburgh Control Sites - Pneumococcal Vaccine|"Adults >=65 years of age at baseline who were active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Control sites were Pittsburgh practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=8)."
123841|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
123842|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
123843|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
123844|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
123845|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
123846|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
123847|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
123848|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
123903|NCT01868334|E2|Reported Event|Year 1 RCCT Pittsburgh Control Sites - Tdap Vaccination|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Control sites were Pittsburgh practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=8)."
123849|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
123850|NCT01868542|E2|Reported Event|Insulin Detemir (2-4-6-8 Algorithm )|"A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done :~>10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir."
123851|NCT01868542|E1|Reported Event|Insulin Detemir (3-0-3 Algorithm )|"A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done :~>6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir."
123852|NCT01868503|B1|Baseline|Treatment (Lapatinib Ditosylate, Radiation Therapy)|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.~lapatinib ditosylate: Given PO~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
123853|NCT01868503|P1|Participant Flow|Treatment (Lapatinib Ditosylate, Radiation Therapy)|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.~lapatinib ditosylate: Given PO~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
123854|NCT01868503|O1|Outcome|Treatment (Lapatinib Ditosylate, Radiation Therapy)|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.~lapatinib ditosylate: Given PO~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
123855|NCT01868503|O1|Outcome|Treatment (Lapatinib Ditosylate, Radiation Therapy)|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.~lapatinib ditosylate: Given PO~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
123856|NCT01868503|O1|Outcome|Treatment (Lapatinib Ditosylate, Radiation Therapy)|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.~lapatinib ditosylate: Given PO~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
123857|NCT01868503|O1|Outcome|All Participants|
123858|NCT01868503|O1|Outcome|Lapatinib Plus Radiation Therapy|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks and will have their blood banked for laboratory biomarker analysis.~lapatinib ditosylate: Given PO~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
123859|NCT01868503|E1|Reported Event|Treatment (Lapatinib Ditosylate, Radiation Therapy)|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.~lapatinib ditosylate: Given PO~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
123860|NCT01868334|B5|Baseline|Total|Total of all reporting groups
123861|NCT01868334|B4|Baseline|Houston Control/Maintenance|"Practices: Represents 3 clinical practices who were control practices in Year 1 and who received the intervention in Year 2.~Patients: Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013 (Tdap, pneumococcal) and 8/1/2012 to 1/31/2013 (influenza), Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 (Tdao, pneumococcal) and 8/1/2013 to 1/31/2014 (influenza) and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015 (Tdap, pneumococcal) and 8/1/2014 to 1/31/2015 (influenza)."
123862|NCT01868334|B3|Baseline|Houston Intervention|"Practices: Represents 3 clinical practices engaged in active intervention in Year 1.~Patients: Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013 (Tdap, pneumococcal) and 8/1/2012 to 1/31/2013 (influenza), Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 (Tdao, pneumococcal) and 8/1/2013 to 1/31/2014 (influenza) and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015 (Tdap, pneumococcal) and 8/1/2014 to 1/31/2015 (influenza)."
123863|NCT01868334|B2|Baseline|Pittsburgh Control/Maintenance|"Practices: Represents 8 clinical practices who were control practices in Year 1 and who received the intervention in Year 2.~Patients: Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013 (Tdap, pneumococcal) and 8/1/2012 to 1/31/2013 (influenza), Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 (Tdao, pneumococcal) and 8/1/2013 to 1/31/2014 (influenza) and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015 (Tdap, pneumococcal) and 8/1/2014 to 1/31/2015 (influenza)."
123960|NCT01867710|B1|Baseline|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 5 mg tablet orally twice daily up to 156 Weeks.
123865|NCT01868334|P4|Participant Flow|Houston Control/Maintenance Sites|"Practices: Clinical practices were stratified by metropolitan area (e.g., Houston) and then randomized into the intervention or control arms within strata.~Patients: Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013 (Tdap, PCV) and 8/1/2012 to 1/31/2013 (influenza), Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Year 1 RCCT study: Control sites were Houston practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=3).~Year 2 Pre-post study: Maintenance sites were Houston practices who were intervened upon in Year 1 but who did not actively participate in continued engagement of the 4 Pillars Program for raising adult vaccination rates during Year 2 (N=3)."
123866|NCT01868334|P3|Participant Flow|Houston Intervention Sites|"Practices: Clinical practices were stratified by metropolitan area (e.g., Houston) and then randomized into the intervention or control arms within strata.~Patients: Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013 (Tdap, PCV) and 8/1/2012 to 1/31/2013 (influenza), Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Year 1 RCCT study: Intervention sites were Houston practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult vaccination rates (N=3).~Year 2 Pre-post study: Year 2 Houston practices were control sites from Year 1 (N=3) who now were actively engaged in the intervention to increase adult vaccination rates."
123867|NCT01868334|P2|Participant Flow|Pittsburgh Control/Maintenance Sites|"Practices: Clinical practices were stratified by metropolitan area (e.g., Pittsburgh) and then randomized into the intervention or control arms within strata.~Patients: Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013 (Tdap, PCV) and 8/1/2012 to 1/31/2013 (influenza), Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Year 1 RCCT study: Control sites were Pittsburgh practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=8).~Year 2 Pre-post study: Maintenance sites were Pittsburgh practices who were intervened upon in Year 1 but who did not actively participate in continued engagement of the 4 Pillars Program for raising adult vaccination rates during Year 2 (N=6)."
123868|NCT01868334|P1|Participant Flow|Pittsburgh Intervention Sites|"Practices: Clinical practices were stratified by metropolitan area (e.g., Pittsburgh) and then randomized into the intervention or control arms within strata.~Patients: Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013 (Tdap, PCV) and 8/1/2012 to 1/31/2013 (influenza), Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Year 1 RCCT Study: Intervention sites were Pittsburgh practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult vaccination rates (N=10).~Year 2 Pre-post study: Year 2 Pittsburgh practices were control sites from Year 1 (N=8) who now were actively engaged in the intervention and Year 1 sites who continued active use of the intervention during year 2 (N=4) to increase adult vaccination rates."
123869|NCT01868334|O12|Outcome|Year 2 Pre-post Study Houston Maintenance Sites - Influenza|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015.~Maintenance sites were Houston practices who were intervened upon in Year 1 but who did not actively participate in continued engagement of the 4 Pillars Program for raising adult influenza vaccination rates during Year 2 (N=3)."
123870|NCT01868334|O11|Outcome|Year 2 Pre-post Study Houston Intervention Sites - Influenza|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015.~Year 2 Houston practices were control sites from Year 1 (N=3) who now were actively engaged in the intervention to increase adult influenza vaccination rates."
123871|NCT01868334|O10|Outcome|Year 2 Pre-post Study Houston Maintenance Sites - PPSV|"Adults >=65 years of age at baseline who were active patients of 25 diverse practices who were seen >=1 time each year. Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Maintenance sites were Houston practices who were intervened upon in Year 1 but who did not actively participate in continued engagement of the 4 Pillars Program for raising adult pneumococcal vaccination rates during Year 2 (N=3)."
123872|NCT01868334|O9|Outcome|Year 2 Pre-post Study Houston Intervention Sites - PPSV|"Adults >=65 years of age at baseline who were active patients of 25 diverse practices who were seen >=1 time each year. Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Year 2 Houston practices were control sites from Year 1 (N=3) who now were actively engaged in the intervention to raise adult pneumococcal vaccination rates."
123873|NCT01868334|O8|Outcome|Year 2 Pre-post Study Houston Maintenance Sites - Tdap|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Maintenance sites were Houston practices who were intervened upon in Year 1 but who did not actively participate in continued engagement of the 4 Pillars Program for raising adult Tdap vaccination rates during Year 2 (N=3)."
123874|NCT01868334|O7|Outcome|Year 2 Pre-post Study Houston Intervention Sites - Tdap|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Year 2 Houston practices were control sites from Year 1 (N=3) who now were actively engaged in the intervention to increase adult Tdap vaccination rates."
123875|NCT01868334|O6|Outcome|Year 2 Pre-post Study Pittsburgh Maintenance Sites - Influenza|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015.~Maintenance sites were Pittsburgh practices who were intervened upon in Year 1 but who did not actively participate in continued engagement of the 4 Pillars Program for raising adult influenza vaccination rates during Year 2 (N=6)."
123876|NCT01868334|O5|Outcome|Year 2 Pre-post Study Pittsburgh Intervention Sites-Influenza|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015.~Year 2 Pittsburgh practices were control sites from Year 1 (N=8) who now were actively engaged in the intervention and Year 1 sites who continued active use of the intervention during year 2 (N=4) to increase adult influenza vaccination rates."
123877|NCT01868334|O4|Outcome|Year 2 Pre-post Study Pittsburgh Maintenance Sites - PPSV|"Adults >=65 years of age at baseline who were active patients of 25 diverse practices who were seen >=1 time each year. Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Maintenance sites were Pittsburgh practices who were intervened upon in Year 1 but who did not actively participate in continued engagement of the 4 Pillars Program for raising adult pneumococcal vaccination rates during Year 2 (N=6)."
123878|NCT01868334|O3|Outcome|Year 2 Pre-post Study Pittsburgh Intervention Sites - PPSV|"Adults >=65 years of age at baseline who were active patients of 25 diverse practices who were seen >=1 time each year. Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Year 2 Pittsburgh practices were control sites from Year 1 (N=8) who now were actively engaged in the intervention and Year 1 sites who continued active use of the intervention during year 2 (N=4) to increase adult pneumococcal vaccination rates."
123879|NCT01868334|O2|Outcome|Year 2 Pre-post Study Pittsburgh Maintenance Sites - Tdap|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Maintenance sites were Pittsburgh practices who were intervened upon in Year 1 but who did not actively participate in continued engagement of the 4 Pillars Program for raising adult Tdap vaccination rates during Year 2 (N=6)."
123880|NCT01868334|O1|Outcome|Year 2 Pre-post Study Pittsburgh Intervention Sites - Tdap|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Year 2 Pittsburgh practices were control sites from Year 1 (N=8) who now were actively engaged in the intervention and Year 1 sites who continued active use of the intervention during year 2 (N=4) to increase adult Tdap vaccination rates."
123881|NCT01868334|O12|Outcome|Year 1 RCCT Houston Control Sites - Influenza Vaccination|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 8/1/2012 to 1/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015.~Control sites were Houston practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=3)."
123882|NCT01868334|O11|Outcome|Year 1 RCCT Houston Intervention Sites - Influenza Vaccination|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 8/1/2012 to 1/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015.~Intervention sites were Houston practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult influenza vaccination (N=3)."
123883|NCT01868334|O10|Outcome|Year 1 RCCT Houston Control Sites - Pneumococcal Vaccine|"Adults >=65 years of age at baseline who were active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Control sites were Houston practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=3)."
123884|NCT01868334|O9|Outcome|Year 1 RCCT Houston Intervention Sites - Pneumococcal Vaccine|"Adults >=65 years of age at baseline who were active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Intervention sites were Houston practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult PPSV vaccination (N=3)."
123885|NCT01868334|O8|Outcome|Year 1 RCCT Houston Control Sites - Tdap Vaccination|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Control sites were Houston practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=3)."
123886|NCT01868334|O7|Outcome|Year 1 RCCT Houston Intervention Sites - Tdap Vaccination|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Intervention sites were Houston practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult Tdap vaccination (N=3)."
123887|NCT01868334|O6|Outcome|Year 1 RCCT Pittsburgh Control Sites - Influenza Vaccine|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 8/1/2012 to 1/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015.~Control sites were Pittsburgh practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=8)."
123888|NCT01868334|O5|Outcome|Year 1 RCCT Pittsburgh Intervention Sites - Influenza Vaccine|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 8/1/2012 to 1/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015.~Intervention sites were Pittsburgh practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult influenza vaccination (N=10)."
123961|NCT01867710|P4|Participant Flow|Abiraterone Acetate 1000milligram(mg)QD+Dexamethasone 0.5mg QD|Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally once daily up to 156 Weeks.
126429|NCT01854658|O3|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
123890|NCT01868334|O3|Outcome|Year 1 RCCT Pittsburgh Intervention Sites - Pneumococcal Vacc|"Adults >=65 years of age at baseline who were active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Intervention sites were Pittsburgh practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult PPSV vaccination (N=10)."
123891|NCT01868334|O2|Outcome|Year 1 RCCT Pittsburgh Control Sites - Tdap Vaccination|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Control sites were Pittsburgh practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=8)."
123892|NCT01868334|O1|Outcome|Year 1 RCCT Pittsburgh Intervention Sites - Tdap Vaccination|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Intervention sites were Pittsburgh practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult Tdap vaccination (N=10)."
123893|NCT01868334|E12|Reported Event|Year 1 RCCT Houston Control Sites - Influenza Vaccination|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 8/1/2012 to 1/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015.~Control sites were Houston practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=3)."
123894|NCT01868334|E11|Reported Event|Year 1 RCCT Houston Intervention Sites - Influenza Vaccination|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 8/1/2012 to 1/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015.~Intervention sites were Houston practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult influenza vaccination (N=3)."
123895|NCT01868334|E10|Reported Event|Year 1 RCCT Houston Control Sites - Pneumococcal Vaccine|"Adults >=65 years of age at baseline who were active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Control sites were Houston practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=3)."
123896|NCT01868334|E9|Reported Event|Year 1 RCCT Houston Intervention Sites - Pneumococcal Vaccine|"Adults >=65 years of age at baseline who were active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Intervention sites were Houston practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult PPSV vaccination (N=3)."
123897|NCT01868334|E8|Reported Event|Year 1 RCCT Houston Control Sites - Tdap Vaccination|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Control sites were Houston practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=3)."
123898|NCT01868334|E7|Reported Event|Year 1 RCCT Houston Intervention Sites - Tdap Vaccination|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Intervention sites were Houston practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult Tdap vaccination (N=3)."
123899|NCT01868334|E6|Reported Event|Year 1 RCCT Pittsburgh Control Sites - Influenza Vaccine|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 8/1/2012 to 1/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015.~Control sites were Pittsburgh practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=8)."
123900|NCT01868334|E5|Reported Event|Year 1 RCCT Pittsburgh Intervention Sites - Influenza Vaccine|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 8/1/2012 to 1/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015.~Intervention sites were Pittsburgh practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult influenza vaccination (N=10)."
123901|NCT01868334|E4|Reported Event|Year 1 RCCT Pittsburgh Control Sites - Pneumococcal Vaccine|"Adults >=65 years of age at baseline who were active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Control sites were Pittsburgh practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=8)."
123902|NCT01868334|E3|Reported Event|Year 1 RCCT Pittsburgh Intervention Sites - Pneumococcal Vacc|"Adults >=65 years of age at baseline who were active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Intervention sites were Pittsburgh practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult PPSV vaccination (N=10)."
123937|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
123904|NCT01868334|E1|Reported Event|Year 1 RCCT Pittsburgh Intervention Sites - Tdap Vaccination|"Adults > 18 years of age who are active patients of 25 diverse practices who were seen >=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.~Intervention sites were Pittsburgh practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult Tdap vaccination (N=10)."
123905|NCT01868243|B3|Baseline|Total|Total of all reporting groups
123906|NCT01868243|B2|Baseline|Warfarin|"Warfarin adjusted-dose~Warfarin: Warfarin adjusted-dose"
123907|NCT01868243|B1|Baseline|Dabigatran|"Dabigatran 110 mg BID~Dabigatran: Group 1 - Dabigatran 110 mg (50 patients)"
123908|NCT01868243|P2|Participant Flow|Warfarin|"Warfarin adjusted-dose~Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)"
123909|NCT01868243|P1|Participant Flow|Dabigatran|"Dabigatran 110 mg BID~Dabigatran: Group 1 - Dabigatran 110 mg"
123910|NCT01868243|O2|Outcome|Warfarin|"Warfarin adjusted-dose~Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)"
123911|NCT01868243|O1|Outcome|Dabigatran|"Dabigatran 110 mg BID~Dabigatran: Group 1 - Dabigatran 110 mg"
123912|NCT01868243|O2|Outcome|Warfarin|"Warfarin adjusted-dose~Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)"
123913|NCT01868243|O1|Outcome|Dabigatran|"Dabigatran 110 mg BID~Dabigatran: Group 1 - Dabigatran 110 mg"
123914|NCT01868243|E2|Reported Event|Warfarin|"Warfarin adjusted-dose~Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)"
123915|NCT01868243|E1|Reported Event|Dabigatran|"Dabigatran 110 mg BID~Dabigatran: Group 1 - Dabigatran 110 mg"
123916|NCT01868074|B3|Baseline|Total|Total of all reporting groups
123917|NCT01868074|B2|Baseline|Usual Care|Participants were instructed to wear their usual footwear over the course of their pregnancy.
123918|NCT01868074|B1|Baseline|Customized Insole|These participants were casted for customized insoles.
123919|NCT01868074|P2|Participant Flow|Usual Care Group|Participants in the control group were instructed to wear their usual footwear over the course of their pregnancy.
123920|NCT01868074|P1|Participant Flow|Customized Insole Group|Each participant in the intervention group had her insole customized to fit her typical daily footwear and was instructed to wear the insoles as often as possible. Participants in the intervention group had their feet molded by a certified orthotist, using a 3M, soft cast. The casting was done in a non-weight bearing, hind-foot neutral position so the insoles would preserve the long transverse arch and maintain a biomechanically efficient state to control motion at the foot and ankle. These castings were used to custom form insoles with the following characteristics: Footlights athletic or dress model (per participant shoe preference), with 3/16” semi-rigid shells, no arch fill, extrinsic rearfoot and standard intrinsic forefoot posting. A research team member not involved with outcome measurements met with the participants to give them their insoles and confirm they fit.
123921|NCT01868074|O2|Outcome|Usual Care Group|Participants in the control/usual group were instructed to wear their usual footwear over the course of their pregnancy.
123922|NCT01868074|O1|Outcome|Customized Insole Group|This intervention group were casted for customized insoles.
123923|NCT01868074|O2|Outcome|Usual Care Group|Participants in the control/usual group were instructed to wear their usual footwear over the course of their pregnancy.
123924|NCT01868074|O1|Outcome|Customized Insole Group|This intervention group were casted for customized insoles.
123925|NCT01868074|O2|Outcome|Usual Care Group|Participants in the control/usual group were instructed to wear their usual footwear over the course of their pregnancy.
123926|NCT01868074|O1|Outcome|Customized Insole Group|This intervention group were casted for customized insoles.
123927|NCT01868074|E2|Reported Event|Usual Care|Participants were instructed to wear their usual footwear over the course of their pregnancy.
123928|NCT01868074|E1|Reported Event|Customized Insole|These participants were casted for customized insoles.
123929|NCT01868035|B1|Baseline|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
123930|NCT01868035|P1|Participant Flow|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
123931|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
123932|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
123933|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
123934|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
123935|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
123936|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
124098|NCT01867021|P1|Participant Flow|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
123938|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
123939|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
123940|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
123941|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
123942|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
123943|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
123944|NCT01868035|E1|Reported Event|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
123945|NCT01868009|B1|Baseline|DISKUS BID in Period 1 or 2; ELLIPTA QD in Period 1 or 2|Participants who were on their current COPD medication(s) were randomized to receive one of the following two sequences of DPIs containing placebo: (1) DISKUS BID for 5-9 days in Period 1 and ELLIPTA QD for 5-9 days in Period 2; (2) ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
123946|NCT01868009|P2|Participant Flow|ELLIPTA QD in Period 1; DISKUS BID in Period 2|Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
123947|NCT01868009|P1|Participant Flow|DISKUS BID in Period 1; ELLIPTA QD in Period 2|Participants who were on their current chronic obstructive pulmonary disease (COPD) medication(s) were randomized to receive DISKUS twice a day (BID) for 5-9 days in Period 1 and ELLIPTA once a day (QD) for 5-9 days in Period 2. There was no washout period between the two periods. Neither dry powder inhaler (DPI) contained any active treatment; placebo was administered in both DPIs.
123948|NCT01868009|O2|Outcome|ELLIPTA QD in Period 1; DISKUS BID in Period 2|Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
123949|NCT01868009|O1|Outcome|DISKUS BID in Period 1; ELLIPTA QD in Period 2|Participants who were on their current COPD medication(s) were randomized to receive DISKUS BID for 5-9 days in Period 1 and ELLIPTA QD for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
123950|NCT01868009|O2|Outcome|ELLIPTA QD in Period 1; DISKUS BID in Period 2|Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
123951|NCT01868009|O1|Outcome|DISKUS BID in Period 1; ELLIPTA QD in Period 2|Participants who were on their current COPD medication(s) were randomized to receive DISKUS BID for 5-9 days in Period 1 and ELLIPTA QD for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
123952|NCT01868009|O2|Outcome|ELLIPTA QD in Period 1; DISKUS BID in Period 2|Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
123953|NCT01868009|O1|Outcome|DISKUS BID in Period 1; ELLIPTA QD in Period 2|Participants who were on their current COPD medication(s) were randomized to receive DISKUS BID for 5-9 days in Period 1 and ELLIPTA QD for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
123954|NCT01868009|E2|Reported Event|DISKUS BID in Period 1 or 2|Subjects will use the DISKUS inhaler twice daily for 5 to 9 days during the first period followed by the ELLIPTA inhaler once daily for 5 to 9 days during the second period.
123955|NCT01868009|E1|Reported Event|ELLIPTA QD in Period 1 or 2|Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in either Period 1 or Period 2. There was no washout period between the two periods. The DPI did not contain any active treatment; placebo was administered in the DPI.
123956|NCT01867710|B5|Baseline|Total|Total of all reporting groups
123957|NCT01867710|B4|Baseline|Abiraterone Acetate 1000milligram(mg)QD+Dexamethasone 0.5mg QD|Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally once daily up to 156 Weeks.
123958|NCT01867710|B3|Baseline|Abiraterone Acetate 1000 Milligram(mg) QD+Prednisone 2.5mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 2.5 mg tablet orally twice daily up to 156 Weeks.
123959|NCT01867710|B2|Baseline|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg QD|Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally once daily up to 156 Weeks.
144009|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
123962|NCT01867710|P3|Participant Flow|Abiraterone Acetate 1000 Milligram(mg) QD+Prednisone 2.5mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 2.5 mg tablet orally twice daily up to 156 Weeks.
123963|NCT01867710|P2|Participant Flow|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg QD|Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally once daily up to 156 Weeks.
123964|NCT01867710|P1|Participant Flow|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 5 mg tablet orally twice daily up to 156 Weeks.
123965|NCT01867710|O4|Outcome|Abiraterone Acetate 1000milligram(mg)QD+Dexamethasone 0.5mg QD|Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally once daily up to 156 Weeks.
123966|NCT01867710|O3|Outcome|Abiraterone Acetate 1000 Milligram(mg) QD+Prednisone 2.5mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 2.5 mg tablet orally twice daily up to 156 Weeks.
123967|NCT01867710|O2|Outcome|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg QD|Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally once daily up to 156 Weeks.
123968|NCT01867710|O1|Outcome|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 5 mg tablet orally twice daily up to 156 Weeks.
123969|NCT01867710|O4|Outcome|Abiraterone Acetate 1000milligram(mg)QD+Dexamethasone 0.5mg QD|Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally once daily up to 156 Weeks.
123970|NCT01867710|O3|Outcome|Abiraterone Acetate 1000 Milligram(mg) QD+Prednisone 2.5mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 2.5 mg tablet orally twice daily up to 156 Weeks.
123971|NCT01867710|O2|Outcome|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg QD|Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally once daily up to 156 Weeks.
123972|NCT01867710|O1|Outcome|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 5 mg tablet orally twice daily up to 156 Weeks.
123973|NCT01867710|E4|Reported Event|Abiraterone Acetate 1000milligram(mg)QD+Dexamethasone 0.5mg QD|Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally once daily up to 156 Weeks.
123974|NCT01867710|E3|Reported Event|Abiraterone Acetate 1000 Milligram(mg) QD+Prednisone 2.5mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 2.5 mg tablet orally twice daily up to 156 Weeks.
123975|NCT01867710|E2|Reported Event|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg QD|Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally once daily up to 156 Weeks.
123976|NCT01867710|E1|Reported Event|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 5 mg tablet orally twice daily up to 156 Weeks.
123977|NCT01867658|B1|Baseline|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
123978|NCT01867658|P1|Participant Flow|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
123979|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
123980|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
123981|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
123982|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
123983|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
123984|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
123985|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
123986|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
123987|NCT01867658|E1|Reported Event|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
123988|NCT01867632|B3|Baseline|Total|Total of all reporting groups
123989|NCT01867632|B2|Baseline|Retrospective Group|Retrospective cohort of cleft palate patients treated at the same institution and by the same surgeon. These patients received ADM selectively for certain cases (tenuous nasal layer closure, tight oral closure, wide cleft).
123990|NCT01867632|B1|Baseline|Prospective Group|Prospective cohort where all patients routinely received ADM during cleft palate surgery. A tailored piece of Acellular Dermal Matrix will be placed between the oral and nasal layers at the time of a Furlow Palatoplasty for repair of a Cleft Palate.
123991|NCT01867632|P2|Participant Flow|Retrospective Group|Retrospective cohort of cleft palate patients treated at the same institution and by the same surgeon. These patients received ADM selectively for certain cases (tenuous nasal layer closure, tight oral closure, wide cleft).
123992|NCT01867632|P1|Participant Flow|Prospective Group|Prospective cohort where all patients routinely received ADM during cleft palate surgery. A tailored piece of Acellular Dermal Matrix will be placed between the oral and nasal layers at the time of a Furlow Palatoplasty for repair of a Cleft Palate.
123993|NCT01867632|O2|Outcome|Retrospective Group|Retrospective cohort of cleft palate patients treated at the same institution and by the same surgeon. These patients received ADM selectively for certain cases (tenuous nasal layer closure, tight oral closure, wide cleft).
123994|NCT01867632|O1|Outcome|Prospective Group|Prospective cohort where all patients routinely received ADM during cleft palate surgery. A tailored piece of Acellular Dermal Matrix will be placed between the oral and nasal layers at the time of a Furlow Palatoplasty for repair of a Cleft Palate.
123995|NCT01867632|O2|Outcome|Retrospective Group|Retrospective cohort of cleft palate patients treated at the same institution and by the same surgeon. These patients received ADM selectively for certain cases (tenuous nasal layer closure, tight oral closure, wide cleft).
123996|NCT01867632|O1|Outcome|Prospective Group|Prospective cohort where all patients routinely received ADM during cleft palate surgery. A tailored piece of Acellular Dermal Matrix will be placed between the oral and nasal layers at the time of a Furlow Palatoplasty for repair of a Cleft Palate.
123997|NCT01867632|E2|Reported Event|Retrospective Group|Retrospective cohort of cleft palate patients treated at the same institution and by the same surgeon. These patients received ADM selectively for certain cases (tenuous nasal layer closure, tight oral closure, wide cleft).
123998|NCT01867632|E1|Reported Event|Prospective Group|Prospective cohort where all patients routinely received ADM during cleft palate surgery. A tailored piece of Acellular Dermal Matrix will be placed between the oral and nasal layers at the time of a Furlow Palatoplasty for repair of a Cleft Palate.
123999|NCT01867580|B3|Baseline|Total|Total of all reporting groups
124000|NCT01867580|B2|Baseline|V.A.C.Ulta Without Instillation|"Control Arm~V.A.C.Ulta without instillation: NPWT only"
124001|NCT01867580|B1|Baseline|V.A.C.Ulta With Prontosan Instillation|"Treatment Arm~V.A.C.Ulta with instillation: NPWT with instillation of a wound cleanser"
124002|NCT01867580|P2|Participant Flow|V.A.C.Ulta Without Instillation|"Control Arm~V.A.C.Ulta without instillation: NPWT only"
124003|NCT01867580|P1|Participant Flow|V.A.C.Ulta With Prontosan Instillation|"Treatment Arm~V.A.C.Ulta with instillation: NPWT with instillation of a wound cleanser"
124004|NCT01867580|O2|Outcome|V.A.C.Ulta Without Instillation|"Control Arm~V.A.C.Ulta without instillation: NPWT only"
124005|NCT01867580|O1|Outcome|V.A.C.Ulta With Prontosan Instillation|"Treatment Arm~V.A.C.Ulta with instillation: NPWT with instillation of a wound cleanser"
124006|NCT01867580|O2|Outcome|V.A.C.Ulta Without Instillation|"Control Arm~V.A.C.Ulta without instillation: NPWT only"
124007|NCT01867580|O1|Outcome|V.A.C.Ulta With Prontosan Instillation|"Treatment Arm~V.A.C.Ulta with instillation: NPWT with instillation of a wound cleanser"
124008|NCT01867580|O2|Outcome|V.A.C.Ulta Without Instillation|"Control Arm~V.A.C.Ulta without instillation: NPWT only"
124009|NCT01867580|O1|Outcome|V.A.C.Ulta With Prontosan Instillation|"Treatment Arm~V.A.C.Ulta with instillation: NPWT with instillation of a wound cleanser"
124010|NCT01867580|E2|Reported Event|V.A.C.Ulta Without Instillation|"Control Arm~V.A.C.Ulta without instillation: NPWT only"
124011|NCT01867580|E1|Reported Event|V.A.C.Ulta With Prontosan Instillation|"Treatment Arm~V.A.C.Ulta with instillation: NPWT with instillation of a wound cleanser"
124012|NCT01867515|B4|Baseline|Total|Total of all reporting groups
124013|NCT01867515|B3|Baseline|Hearing-impaired Listeners|"individuals with bilateral sensorineural hearing losses with thresholds between 25 and 70 dB HL and no losses greater than 70 dB HL at frequencies of 4000 Hz or below~age 18 to 65"
124014|NCT01867515|B2|Baseline|Older Normally-hearing Listeners|"Participants with auditory thresholds within the normal limits.~age 36 to 65~individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz"
124015|NCT01867515|B1|Baseline|Younger Normally-hearing Listeners|"Participants with auditory thresholds within the normal limits.~age 18 to 35~individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz"
124016|NCT01867515|P3|Participant Flow|Hearing-impaired Listeners|"individuals with bilateral sensorineural hearing losses with thresholds between 25 and 70 dB HL and no losses greater than 70 dB HL at frequencies of 4000 Hz or below~age 18 to 65"
124017|NCT01867515|P2|Participant Flow|Older Normally-hearing Listeners|"Participants with auditory thresholds within the normal limits.~age 36 to 65~individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz"
124018|NCT01867515|P1|Participant Flow|Younger Normally-hearing Listeners|"Participants with auditory thresholds within the normal limits.~age 18 to 35~individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz"
124019|NCT01867515|O3|Outcome|Hearing-impaired Listeners|individuals with bilateral sensorineural hearing losses with thresholds between 25 and 70 dB HL and no losses greater than 70 dB HL at frequencies of 4000 Hz or below
124020|NCT01867515|O2|Outcome|Older Normally-hearing|"Participants with auditory thresholds within the normal limits.~age 36 to 65~individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz"
124021|NCT01867515|O1|Outcome|Normally-hearing Listeners|"Participants with auditory thresholds within the normal limits.~age 18 to 35~individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz"
124022|NCT01867515|E3|Reported Event|Hearing-impaired Listeners|"individuals with bilateral sensorineural hearing losses with thresholds between 25 and 70 dB HL and no losses greater than 70 dB HL at frequencies of 4000 Hz or below~age 18 to 65"
124023|NCT01867515|E2|Reported Event|Older Normally-hearing Listeners|"Participants with auditory thresholds within the normal limits.~age 36 to 65~individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz"
124024|NCT01867515|E1|Reported Event|Younger Normally-hearing Listeners|"Participants with auditory thresholds within the normal limits.~age 18 to 35~individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz"
124025|NCT01867424|B3|Baseline|Total|Total of all reporting groups
124026|NCT01867424|B2|Baseline|Participants With Localized Disease|"Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.~Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient"
124050|NCT01867164|B2|Baseline|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
124099|NCT01867021|O2|Outcome|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
144010|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
124027|NCT01867424|B1|Baseline|Participants With Advanced Disease|"Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.~Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient"
124028|NCT01867424|P2|Participant Flow|Participants With Localized Disease|"Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.~Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient"
124029|NCT01867424|P1|Participant Flow|Participants With Advanced Disease|"Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.~Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient"
124030|NCT01867424|O2|Outcome|Participants With Localized Disease|"Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.~Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient"
124031|NCT01867424|O1|Outcome|Participants With Advanced Disease|"Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.~Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient"
124032|NCT01867424|O2|Outcome|Participants With Localized Disease|"Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.~Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient"
124033|NCT01867424|O1|Outcome|Participants With Advanced Disease|"Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.~Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient"
124034|NCT01867424|O2|Outcome|Participants With Localized Disease|"Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.~Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient"
124035|NCT01867424|O1|Outcome|Participants With Advanced Disease|"Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.~Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient"
124036|NCT01867424|O2|Outcome|Participants With Localized Disease|"Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.~Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient"
124037|NCT01867424|O1|Outcome|Participants With Advanced Disease|"Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.~Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient"
124038|NCT01867424|E2|Reported Event|Participants With Localized Disease|"Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.~Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient"
124039|NCT01867424|E1|Reported Event|Participants With Advanced Disease|"Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.~Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient"
124040|NCT01867307|B3|Baseline|Total|Total of all reporting groups
124041|NCT01867307|B2|Baseline|Healthy Subjects|Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days
124042|NCT01867307|B1|Baseline|T2DM Patients|Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days
124043|NCT01867307|P2|Participant Flow|Healthy Subjects|Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days
124044|NCT01867307|P1|Participant Flow|T2DM Patients|Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days
124045|NCT01867307|O2|Outcome|Healthy Subjects|Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days
124046|NCT01867307|O1|Outcome|T2DM Patients|Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days
124047|NCT01867307|E2|Reported Event|Healthy Subjects|Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days
124048|NCT01867307|E1|Reported Event|T2DM Patients|Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days
124049|NCT01867164|B3|Baseline|Total|Total of all reporting groups
144011|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
124051|NCT01867164|B1|Baseline|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
124052|NCT01867164|P2|Participant Flow|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram/milliliter (mcg/ml) nystatin was administered vaginally, every 24 hours at night, for 10 days.
124053|NCT01867164|P1|Participant Flow|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 milligram (mg) terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
124054|NCT01867164|O2|Outcome|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
124055|NCT01867164|O1|Outcome|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
124056|NCT01867164|O2|Outcome|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
124057|NCT01867164|O1|Outcome|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
124058|NCT01867164|O2|Outcome|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
124059|NCT01867164|O1|Outcome|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
124060|NCT01867164|O2|Outcome|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
124061|NCT01867164|O1|Outcome|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
124062|NCT01867164|O2|Outcome|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
124063|NCT01867164|O1|Outcome|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
124064|NCT01867164|E2|Reported Event|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
124065|NCT01867164|E1|Reported Event|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
124066|NCT01867086|B1|Baseline|Vigil™ Vaccine|Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks.
124067|NCT01867086|P1|Participant Flow|Vigil™ Vaccine|"Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone.~Vigil™ Vaccine: Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 3 weeks.~Carboplatinum: Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion)"
124068|NCT01867086|O1|Outcome|Vigil™ Vaccine|"Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone.~Vigil™ Vaccine: Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 3 weeks.~Carboplatinum: Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion)"
124069|NCT01867086|O1|Outcome|Vigil™ Vaccine|"Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone.~Vigil™ Vaccine: Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 3 weeks.~Carboplatinum: Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion)"
126430|NCT01854658|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
124070|NCT01867086|O1|Outcome|Vigil™ Vaccine|"Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone.~Vigil™ Vaccine: Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 3 weeks.~Carboplatinum: Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion)"
124071|NCT01867086|O1|Outcome|Vigil™ Vaccine|"Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone.~Vigil™ Vaccine: Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 3 weeks.~Carboplatinum: Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion)"
124072|NCT01867086|E1|Reported Event|Vigil™ Vaccine|Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks.
124073|NCT01867047|B3|Baseline|Total|Total of all reporting groups
124074|NCT01867047|B2|Baseline|Cessation Group|ACE-I Cessation group: Subjects stop ACE-I 48 hours prior to surgery
124075|NCT01867047|B1|Baseline|Continuation Group|ACE-I Continuation group: Subjects take ACE-I through day of surgery
124076|NCT01867047|P2|Participant Flow|Cessation Group|ACE-I Cessation group: Subjects stop ACE-I 48 hours prior to surgery
124077|NCT01867047|P1|Participant Flow|Continuation Group|ACE-I Continuation group: Subjects take ACE-I through day of surgery
124078|NCT01867047|O2|Outcome|Cessation Group|"Subjects randomized to this group will stop their ACE-I two days prior to surgery (last dose >48 hours prior to surgery)~ACE-I Cessation group: Subjects stop ACE-I 48 hours prior to surgery. Examples of possible ACE-I drugs include:~benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec, Epaned), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), trandolapril (Mavik)"
124079|NCT01867047|O1|Outcome|Continuation Group|"Subjects randomized to this group will continue their ACE-I through the day of surgery~ACE-I Continuation group: Subjects take ACE-I through day of surgery. Examples of possible ACE-I drugs include:~benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec, Epaned), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), trandolapril (Mavik)"
124080|NCT01867047|O2|Outcome|Cessation Group|"Subjects randomized to this group will stop their ACE-I two days prior to surgery (last dose >48 hours prior to surgery)~ACE-I Cessation group: Subjects stop ACE-I 48 hours prior to surgery"
124081|NCT01867047|O1|Outcome|Continuation Group|"Subjects randomized to this group will continue their ACE-I through the day of surgery~ACE-I Continuation group: Subjects take ACE-I through day of surgery"
124082|NCT01867047|O2|Outcome|Cessation Group|"Subjects randomized to this group will stop their ACE-I two days prior to surgery (last dose >48 hours prior to surgery)~ACE-I Cessation group: Subjects stop ACE-I 48 hours prior to surgery"
124083|NCT01867047|O1|Outcome|Continuation Group|"Subjects randomized to this group will continue their ACE-I through the day of surgery~ACE-I Continuation group: Subjects take ACE-I through day of surgery"
124084|NCT01867047|O2|Outcome|Cessation Group|"Subjects randomized to this group will stop their ACE-I two days prior to surgery (last dose >48 hours prior to surgery)~ACE-I Cessation group: Subjects stop ACE-I 48 hours prior to surgery"
124085|NCT01867047|O1|Outcome|Continuation Group|"Subjects randomized to this group will continue their ACE-I through the day of surgery~ACE-I Continuation group: Subjects take ACE-I through day of surgery"
124086|NCT01867047|O2|Outcome|Cessation Group|"Subjects randomized to this group will stop their ACE-I two days prior to surgery (last dose >48 hours prior to surgery)~ACE-I Cessation group: Subjects stop ACE-I 48 hours prior to surgery"
124087|NCT01867047|O1|Outcome|Continuation Group|"Subjects randomized to this group will continue their ACE-I through the day of surgery~ACE-I Continuation group: Subjects take ACE-I through day of surgery"
124088|NCT01867047|O2|Outcome|Cessation Group|"Subjects randomized to this group will stop their ACE-I two days prior to surgery (last dose >48 hours prior to surgery)~ACE-I Cessation group: Subjects stop ACE-I 48 hours prior to surgery"
124089|NCT01867047|O1|Outcome|Continuation Group|"Subjects randomized to this group will continue their ACE-I through the day of surgery~ACE-I Continuation group: Subjects take ACE-I through day of surgery"
124090|NCT01867047|O2|Outcome|Cessation Group|ACE-I Cessation group: Subjects stop ACE-I 48 hours prior to surgery
124091|NCT01867047|O1|Outcome|Continuation Group|ACE-I Continuation group: Subjects take ACE-I through day of surgery
124092|NCT01867047|E2|Reported Event|Cessation Group|"Subjects randomized to this group will stop their ACE-I two days prior to surgery (last dose >48 hours prior to surgery)~ACE-I Cessation group: Subjects stop ACE-I 48 hours prior to surgery"
124093|NCT01867047|E1|Reported Event|Continuation Group|"Subjects randomized to this group will continue their ACE-I through the day of surgery~ACE-I Continuation group: Subjects take ACE-I through day of surgery"
124094|NCT01867021|B3|Baseline|Total|Total of all reporting groups
124095|NCT01867021|B2|Baseline|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
124096|NCT01867021|B1|Baseline|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
124097|NCT01867021|P2|Participant Flow|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
124100|NCT01867021|O1|Outcome|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
124101|NCT01867021|O4|Outcome|≥65 years_Fluvirin|Subjects ≥65 years of age who received a control vaccine TIVf
124102|NCT01867021|O3|Outcome|≥65 years_Agriflu|Subjects ≥65 years of age who received an investigational vaccine TIV
124103|NCT01867021|O2|Outcome|≥50 to ≤64 years_Fluvirin|Subjects ≥50 to ≤64 years of age who received a control vaccine TIVf
124104|NCT01867021|O1|Outcome|≥50 to ≤64 years_Agriflu|Subjects ≥50 to ≤64 years of age who received an investigational vaccine TIV
124105|NCT01867021|O4|Outcome|≥65 years_Fluvirin|Subjects ≥65 years of age who received a control vaccine TIVf
124106|NCT01867021|O3|Outcome|≥65 years_Agriflu|Subjects ≥65 years of age who received an investigational vaccine TIV
124107|NCT01867021|O2|Outcome|≥50 to ≤64 years_Fluvirin|Subjects ≥50 to ≤64 years of age who received a control vaccine TIVf
124108|NCT01867021|O1|Outcome|≥50 to ≤64 years_Agriflu|Subjects ≥50 to ≤64 years of age who received an investigational vaccine TIV
124109|NCT01867021|O2|Outcome|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
124110|NCT01867021|O1|Outcome|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
124111|NCT01867021|O2|Outcome|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
124112|NCT01867021|O1|Outcome|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
124113|NCT01867021|E3|Reported Event|Total|Total number of Subjects
124114|NCT01867021|E2|Reported Event|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
124115|NCT01867021|E1|Reported Event|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
124116|NCT01866943|B1|Baseline|All Study Participants|"Baseline population, Groups are as follows:~Group 1 (Normal Saline Solution) Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.~Group 2 (Tranexamic Acid) Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline plus 1.5 g (100 mg/mL)Tranexamic Acid is applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.~Tranexamic Acid: Tranexamic Acid 1.5 g (100 mg/mL)in 100cc normal saline is applied topically to the wound for 5 minutes time then suctioned and the skin closed. The control group receives just normal saline and no drug.~Since only blinded and deidentified data is available, Baseline measures will be reported on the entire population."
124117|NCT01866943|P2|Participant Flow|Group 2|"Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline plus 1.5 g (100 mg/mL)Tranexamic Acid is applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.~Tranexamic Acid: Tranexamic Acid 1.5 g (100 mg/mL)in 100cc normal saline is applied topically to the wound for 5 minutes time then suctioned and the skin closed. The control group receives just normal saline and no drug."
124118|NCT01866943|P1|Participant Flow|Group 1|"Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.~Normal Saline Solution"
124119|NCT01866943|O1|Outcome|All Study Participants|Data for this outcome is available for 31 subjects, and group membership is unknown as all data available is de-identified and blinded. Therefore data in these 31 subjects is reported.
124120|NCT01866943|O1|Outcome|All Study Participants|Data for this outcome is available for 35 subjects, and group membership is unknown as all data available is de-identified and blinded. Therefore data in these 35 subjects is reported.
124121|NCT01866943|O1|Outcome|All Study Participants|Data for this outcome is available for 4 subjects, and group membership is unknown as all data available is de-identified and blinded. Therefore data in these 4 subjects is reported.
124122|NCT01866943|O1|Outcome|Baseline Population|Data for this outcome measure is available for 16 subjects, and cannot determine between groups as only data available is de-identified and blinded. Therefore data for these 16 subjects is reported.
124123|NCT01866943|O1|Outcome|Baseline Population|Data for 12 subjects is available, and cannot determine between groups as only data available is de-identified and blinded. Reporting data for these 12 subjects.
124124|NCT01866943|E2|Reported Event|Group 2|"Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline plus 1.5 g (100 mg/mL)Tranexamic Acid is applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.~Tranexamic Acid: Tranexamic Acid 1.5 g (100 mg/mL)in 100cc normal saline is applied topically to the wound for 5 minutes time then suctioned and the skin closed. The control group receives just normal saline and no drug."
124125|NCT01866943|E1|Reported Event|Group 1|"Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.~Normal Saline Solution"
124126|NCT01866709|B3|Baseline|Total|Total of all reporting groups
124127|NCT01866709|B2|Baseline|Silicified Microcrystalline Cellulose|"Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.~Silicified microcrystalline cellulose (PLACEBO)~Total Study Enrollment: Assessed for eligibility (n= 36 )~Excluded (n= 4)~Not meeting inclusion criteria (n= 4 )~Declined to participate (n= 0)~Other reasons (n= 0 )~Total Randomized (n= 32 )~Allocated to intervention (n= 17): PLACEBO~Received allocated intervention (n= 17 )~Did not receive allocated intervention (give reasons) (n= 0)~Lost to follow-up (give reasons) (n= 0 )~Discontinued intervention (give reasons) (n= 0)~Analysed (n= 0)~◻ Excluded from analysis (give reasons) (n= 17): study terminated early due to safety reasons"
124144|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
144012|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
124128|NCT01866709|B1|Baseline|Sodium Polystyrene Sulfonate|"Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.~Sodium polystyrene sulfonate (ACTIVE)~Total Study Enrollment: Assessed for eligibility (n= 36 )~Excluded (n= 4)~Not meeting inclusion criteria (n= 4 )~Declined to participate (n= 0)~Other reasons (n= 0 )~Total Randomized (n= 32 )~Allocated to intervention (n= 15 ): ACTIVE~Received allocated intervention (n= 15)~Did not receive allocated intervention (give reasons) (n= 0 )~Lost to follow-up (give reasons) (n= 0 )~Discontinued intervention before study terminated (n= 1): non-serious adverse event~Analysed (n= 0)~◻ Excluded from analysis (give reasons) (n= 15): study terminated early due to safety reasons"
124129|NCT01866709|P2|Participant Flow|Silicified Microcrystalline Cellulose|"Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.~Enrollment: Assessed for eligibility (n= 36 )~Excluded (n= 4)~Not meeting inclusion criteria (n= 4 )~Declined to participate (n= 0)~Other reasons (n= 0 )~Randomized (n= 32 )~Allocated to intervention (n= 17): PLACEBO~Received allocated intervention (n= 17 )~Did not receive allocated intervention (give reasons) (n= 0)~Lost to follow-up (give reasons) (n= 0 )~Analyzed (n= 0)~◻ Excluded from analysis (give reasons) (n= 32 study terminated early due to safety reasons)"
124130|NCT01866709|P1|Participant Flow|Sodium Polystyrene Sulfonate|"Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.~Enrollment: Assessed for eligibility (n= 36 )~Excluded (n= 4)~Not meeting inclusion criteria (n= 4 )~Declined to participate (n= 0)~Other reasons (n= 0 )~Randomized (n= 32 )~Allocated to intervention (n= 15 ): ACTIVE~Received allocated intervention (n= 15)~Did not receive allocated intervention (give reasons) (n= 0 )~Lost to follow-up (give reasons) (n= 0 )~Discontinued intervention before study terminated (n= 1): non-serious adverse event~Analyzed (n= 0)~◻ Excluded from analysis (give reasons) (n= 32 study terminated early due to safety reasons)"
124131|NCT01866709|O2|Outcome|Silicified Microcrystalline Cellulose|"Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.~Silicified microcrystalline cellulose"
124132|NCT01866709|O1|Outcome|Sodium Polystyrene Sulfonate|"Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.~Sodium polystyrene sulfonate"
124133|NCT01866709|O2|Outcome|Silicified Microcrystalline Cellulose|"Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.~Silicified microcrystalline cellulose"
124134|NCT01866709|O1|Outcome|Sodium Polystyrene Sulfonate|"Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.~Sodium polystyrene sulfonate"
124135|NCT01866709|E2|Reported Event|Silicified Microcrystalline Cellulose|"Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.~Silicified microcrystalline cellulose (PLACEBO): Participants were solicited for adverse events at each study visit (i.e. Days 1, 2 and 9) by systematic regular investigator assessment."
124136|NCT01866709|E1|Reported Event|Sodium Polystyrene Sulfonate|"Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.~Sodium polystyrene sulfonate (ACTIVE): Participants were solicited for adverse events at each study visit (i.e. Days 1, 2 and 9) by systematic regular investigator assessment."
124137|NCT01866592|B1|Baseline|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124138|NCT01866592|P1|Participant Flow|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124139|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124140|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124141|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124142|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124143|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124184|NCT01866319|P3|Participant Flow|Pembrolizumab Q3W|Participants receive pembrolizumab, 10 mg/kg IV, Q3W for up to 2 years
124185|NCT01866319|P2|Participant Flow|Pembrolizumab Q2W|Participants receive pembrolizumab, 10 mg/kg IV, once every 2 weeks (Q2W) for up to 2 years
124145|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124146|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124147|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124148|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124149|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124150|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124151|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124152|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124153|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124154|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124155|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124156|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124157|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124158|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124159|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124160|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124186|NCT01866319|P1|Participant Flow|Ipilimumab|Participants receive ipilimumab, 3 mg/kg intravenously (IV), once eveery 3 weeks (Q3W) for a total of 4 doses
144013|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
124161|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124162|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124163|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124164|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124165|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124166|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124167|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124168|NCT01866592|O1|Outcome|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124169|NCT01866592|E1|Reported Event|Single-Arm, Open-label Extension Trial|"Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.~Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks."
124170|NCT01866423|B1|Baseline|Treatment (Orteronel)|"Patients receive orteronel 300 mg PO twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~orteronel: Given PO~laboratory biomarker analysis: Correlative studies"
124171|NCT01866423|P1|Participant Flow|Treatment (Orteronel)|"Patients receive orteronel 300 mg PO BID (twice a day) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~orteronel: Given PO~laboratory biomarker analysis: Correlative studies"
124172|NCT01866423|O1|Outcome|Treatment (Orteronel)|"Patients receive orteronel 300 mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~orteronel: Given PO~laboratory biomarker analysis: Correlative studies"
124173|NCT01866423|O1|Outcome|Treatment (Orteronel)|"Patients receive orteronel 300 mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~orteronel: Given PO~laboratory biomarker analysis: Correlative studies"
124174|NCT01866423|O1|Outcome|Treatment (Orteronel)|"Patients receive orteronel 300 mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~orteronel: Given PO~laboratory biomarker analysis: Correlative studies"
124175|NCT01866423|O1|Outcome|Treatment (Orteronel)|"Patients receive orteronel 300 mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~orteronel: Given PO~laboratory biomarker analysis: Correlative studies"
124176|NCT01866423|O1|Outcome|Treatment (Orteronel)|"Patients receive orteronel 300 mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~orteronel: Given PO~laboratory biomarker analysis: Correlative studies"
124177|NCT01866423|O1|Outcome|Treatment (Orteronel)|"Patients receive orteronel 300 mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~orteronel: Given PO~laboratory biomarker analysis: Correlative studies"
124178|NCT01866423|O1|Outcome|Treatment (Orteronel)|"Patients receive orteronel 300 mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~orteronel: Given PO~laboratory biomarker analysis: Correlative studies"
124179|NCT01866423|E1|Reported Event|Treatment (Orteronel)|"Patients receive orteronel 300 mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~orteronel: Given PO~laboratory biomarker analysis: Correlative studies"
124180|NCT01866319|B4|Baseline|Total|Total of all reporting groups
124181|NCT01866319|B3|Baseline|Pembrolizumab Q3W|Participants receive pembrolizumab, 10 mg/kg IV, Q3W for up to 2 years
124182|NCT01866319|B2|Baseline|Pembrolizumab Q2W|Participants receive pembrolizumab, 10 mg/kg IV, Q2W for up to 2 years
124183|NCT01866319|B1|Baseline|Ipilimumab|Participants receive ipilimumab, 3 mg/kg IV, Q3W for a total of 4 doses
144014|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
124187|NCT01866319|O3|Outcome|Pembrolizumab Q3W|Participants receive pembrolizumab, 10 mg/kg IV, Q3W for up to 2 years
124188|NCT01866319|O2|Outcome|Pembrolizumab Q2W|Participants receive pembrolizumab, 10 mg/kg IV, Q2W for up to 2 years
124189|NCT01866319|O1|Outcome|Ipilimumab|Participants receive ipilimumab, 3 mg/kg IV, Q3W for a total of 4 doses
124190|NCT01866319|O3|Outcome|Pembrolizumab Q3W|Participants receive pembrolizumab, 10 mg/kg IV, Q3W for up to 2 years
124191|NCT01866319|O2|Outcome|Pembrolizumab Q2W|Participants receive pembrolizumab, 10 mg/kg IV, Q2W for up to 2 years
124192|NCT01866319|O1|Outcome|Ipilimumab|Participants receive ipilimumab, 3 mg/kg IV, Q3W for a total of 4 doses
124193|NCT01866319|O3|Outcome|Pembrolizumab Q3W|Participants receive pembrolizumab, 10 mg/kg IV, Q3W for up to 2 years
124194|NCT01866319|O2|Outcome|Pembrolizumab Q2W|Participants receive pembrolizumab, 10 mg/kg IV, Q2W for up to 2 years
124195|NCT01866319|O1|Outcome|Ipilimumab|Participants receive ipilimumab, 3 mg/kg IV, Q3W for a total of 4 doses
124196|NCT01866319|E3|Reported Event|Pembrolizumab 10 mg/kg Q3W|Participants receive pembrolizumab, 10 mg/kg IV, Q3W for up to 2 years
124197|NCT01866319|E2|Reported Event|Pembrolizumab 10 mg/kg Q2W|Participants receive pembrolizumab, 10 mg/kg IV, Q2W for up to 2 years
124198|NCT01866319|E1|Reported Event|Ipilimumab 3 mg/kg Q3W|Participants receive ipilimumab, 3 mg/kg IV, Q3W for a total of 4 doses
124199|NCT01866306|B8|Baseline|Total|Total of all reporting groups
124200|NCT01866306|B7|Baseline|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124201|NCT01866306|B6|Baseline|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124202|NCT01866306|B5|Baseline|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124203|NCT01866306|B4|Baseline|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124204|NCT01866306|B3|Baseline|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124205|NCT01866306|B2|Baseline|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124206|NCT01866306|B1|Baseline|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124207|NCT01866306|P7|Participant Flow|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124208|NCT01866306|P6|Participant Flow|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124209|NCT01866306|P5|Participant Flow|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124210|NCT01866306|P4|Participant Flow|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124211|NCT01866306|P3|Participant Flow|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124212|NCT01866306|P2|Participant Flow|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124213|NCT01866306|P1|Participant Flow|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124214|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124215|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124216|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124217|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124218|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124219|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124220|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124221|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124373|NCT01865084|O3|Outcome|0.6 mg/kg Tadalafil|0.6 mg/kg taken tadalafil orally once daily.
124222|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124223|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124224|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124225|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124226|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124227|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124228|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124229|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124230|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124231|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124232|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124233|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124234|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124235|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124236|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124237|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124238|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124239|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124240|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124241|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124242|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124243|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124244|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124245|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124246|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124247|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124248|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124249|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124250|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124374|NCT01865084|O2|Outcome|0.3 mg/kg Tadalafil|0.3 mg/kg tadalafil taken orally once daily.
124375|NCT01865084|O1|Outcome|Placebo|Placebo taken orally once daily.
124251|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124252|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124253|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124254|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124255|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124256|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124257|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124258|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124259|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124260|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124261|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124262|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124263|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124264|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124265|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124266|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124267|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124268|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124269|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124270|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124271|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124272|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124273|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124274|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124275|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124276|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124277|NCT01866306|E7|Reported Event|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124278|NCT01866306|E6|Reported Event|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124279|NCT01866306|E5|Reported Event|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124376|NCT01865084|E5|Reported Event|0.6 mg/kg Tadalafil - OLE|0.6 mg/kg tadalafil taken orally once daily.
124280|NCT01866306|E4|Reported Event|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124281|NCT01866306|E3|Reported Event|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124282|NCT01866306|E2|Reported Event|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124283|NCT01866306|E1|Reported Event|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
124284|NCT01866293|B1|Baseline|Cabozantinib (XL184)|"Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.~Cabozantinib (XL184)"
124285|NCT01866293|P1|Participant Flow|Cabozantinib (XL184)|"Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.~Cabozantinib (XL184)"
124286|NCT01866293|O1|Outcome|Cabozantinib (XL184)|Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
124287|NCT01866293|O1|Outcome|Cabozantinib (XL184)|Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
124288|NCT01866293|O1|Outcome|Cabozantinib (XL184)|Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
124289|NCT01866293|O1|Outcome|Cabozantinib (XL184)|Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
124290|NCT01866293|O1|Outcome|Cabozantinib (XL184)|Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
124291|NCT01866293|E1|Reported Event|Cabozantinib (XL184)|Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
124292|NCT01866163|B3|Baseline|Total|Total of all reporting groups
124293|NCT01866163|B2|Baseline|Vehicle|Aerosol foam vehicle
124294|NCT01866163|B1|Baseline|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
124295|NCT01866163|P2|Participant Flow|Vehicle|Aerosol foam vehicle
124296|NCT01866163|P1|Participant Flow|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
124297|NCT01866163|O2|Outcome|Vehicle|Aerosol foam vehicle
124298|NCT01866163|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
124299|NCT01866163|O2|Outcome|Vehicle|Aerosol foam vehicle
124300|NCT01866163|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
124301|NCT01866163|O2|Outcome|Vehicle|Aerosol foam vehicle
124302|NCT01866163|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
124303|NCT01866163|E2|Reported Event|Vehicle|Aerosol foam vehicle
124304|NCT01866163|E1|Reported Event|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
124305|NCT01866150|B1|Baseline|Overall Population|Retrospective chart review of all participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy or biologic combination therapy according to NICE guidelines. Biologic combination therapy included biologic drug therapy (any) plus MTX or biologic plus MTX plus any other and classical DMARDs.
124306|NCT01866150|P1|Participant Flow|Overall Population|Retrospective chart review of all participants with rheumatoid arthritis (RA) who were being treated with first-line biologic drug therapy (any) as monotherapy or biologic combination therapy according to National Institute for Health and Care Excellence (NICE) guidelines. Biologic combination therapy included biologic drug therapy (any) plus methotrexate (MTX) or biologic plus MTX plus any other and classical disease-modifying antirheumatic drugs (DMARDs).
124307|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
124308|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
124309|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
144015|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
124310|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
124311|NCT01866150|O1|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
124312|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
124313|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
124314|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
124315|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
124316|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
124317|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
124318|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
124319|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
124320|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
124321|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
124322|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
124323|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
124324|NCT01866150|E2|Reported Event|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (only rituximab or tocilizumab) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
124325|NCT01866150|E1|Reported Event|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (only rituximab or tocilizumab) as monotherapy according to NICE guidelines.
124326|NCT01865812|B1|Baseline|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks~obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
124327|NCT01865812|P1|Participant Flow|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks~obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
124328|NCT01865812|O1|Outcome|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks~obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
124329|NCT01865812|O1|Outcome|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks~obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
124330|NCT01865812|O1|Outcome|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks~obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
124377|NCT01865084|E4|Reported Event|0.3 mg/kg Tadalafil - OLE|0.3 mg/kg tadalafil taken orally once daily.
124378|NCT01865084|E3|Reported Event|0.6 mg/kg Tadalafil - DB|0.6 mg/kg tadalafil taken orally once daily.
124379|NCT01865084|E2|Reported Event|0.3 mg/kg Tadalafil -DB|0.3 milligram per kilogram (mg/kg) tadalafil taken orally once daily.
124380|NCT01865084|E1|Reported Event|Placebo - DB|Placebo taken orally once daily.
124331|NCT01865812|E1|Reported Event|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks~obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
124332|NCT01865747|B3|Baseline|Total|Total of all reporting groups
124333|NCT01865747|B2|Baseline|Everolimus (Afinitor)|"Everolimus (Afinitor) 10 mg tablet once daily.~Everolimus (Afinitor) tablets"
124334|NCT01865747|B1|Baseline|Cabozantinib (XL184)|"Cabozantinib (XL184) 60 mg tablet once daily.~Cabozantinib tablets"
124335|NCT01865747|P2|Participant Flow|Everolimus (Afinitor)|"Everolimus (Afinitor) 10 mg tablet once daily.~Everolimus (Afinitor) tablets"
124336|NCT01865747|P1|Participant Flow|Cabozantinib (XL184)|"Cabozantinib (XL184) 60 mg tablet once daily.~Cabozantinib tablets"
124337|NCT01865747|O2|Outcome|Everolimus (Afinitor)|"Everolimus (Afinitor) 10 mg tablet once daily.~Everolimus (Afinitor) tablets"
124338|NCT01865747|O1|Outcome|Cabozantinib (XL184)|"Cabozantinib (XL184) 60 mg tablet once daily.~Cabozantinib tablets"
124339|NCT01865747|O2|Outcome|Everolimus (Afinitor)|"Everolimus (Afinitor) 10 mg tablet once daily.~Everolimus (Afinitor) tablets"
124340|NCT01865747|O1|Outcome|Cabozantinib (XL184)|"Cabozantinib (XL184) 60 mg tablet once daily.~Cabozantinib tablets"
124341|NCT01865747|O2|Outcome|Everolimus (Afinitor)|"Everolimus (Afinitor) 10 mg tablet once daily.~Everolimus (Afinitor) tablets"
124342|NCT01865747|O1|Outcome|Cabozantinib (XL184)|"Cabozantinib (XL184) 60 mg tablet once daily.~Cabozantinib tablets"
124343|NCT01865747|E2|Reported Event|Everolimus (Afinitor)|"Everolimus (Afinitor) 10 mg tablet once daily.~Everolimus (Afinitor) tablets"
124344|NCT01865747|E1|Reported Event|Cabozantinib (XL184)|"Cabozantinib (XL184) 60 mg tablet once daily.~Cabozantinib tablets"
124345|NCT01865708|B1|Baseline|Ethanol Lock|74% Ethanol lock will begin within 24 hours of urinary catheter placement. Lock will be done every 24 hours for 1 hour. The volume that will be instilled depends upon the fill volume of the catheter, which is imprinted by the manufacturer on each catheter. Once the alcohol is in the catheter, the proximal end of the catheter will be clamped for 1 hour. After 1 hour dwell time, the clamp will be removed and catheter will be flushed out by the patient's own urine output.
124346|NCT01865708|P1|Participant Flow|Ethanol Lock|74% Ethanol lock will begin within 24 hours of urinary catheter placement. Lock will be done every 24 hours for 1 hour. The volume that will be instilled depends upon the fill volume of the catheter, which is imprinted by the manufacturer on each catheter. Once the alcohol is in the catheter, the proximal end of the catheter will be clamped for 1 hour. After 1 hour dwell time, the clamp will be removed and catheter will be flushed out by the patient's own urine output.
124347|NCT01865708|O1|Outcome|Ethanol Lock|74% Ethanol lock will begin within 24 hours of urinary catheter placement. Lock will be done every 24 hours for 1 hour. The volume that will be instilled depends upon the fill volume of the catheter, which is imprinted by the manufacturer on each catheter. Once the alcohol is in the catheter, the proximal end of the catheter will be clamped for 1 hour. After 1 hour dwell time, the clamp will be removed and catheter will be flushed out by the patient's own urine output.
124348|NCT01865708|O1|Outcome|Ethanol Lock|74% Ethanol lock will begin within 24 hours of urinary catheter placement. Lock will be done every 24 hours for 1 hour. The volume that will be instilled depends upon the fill volume of the catheter, which is imprinted by the manufacturer on each catheter. Once the alcohol is in the catheter, the proximal end of the catheter will be clamped for 1 hour. After 1 hour dwell time, the clamp will be removed and catheter will be flushed out by the patient's own urine output.
124349|NCT01865708|E1|Reported Event|Ethanol Lock|74% Ethanol lock will begin within 24 hours of urinary catheter placement. Lock will be done every 24 hours for 1 hour. The volume that will be instilled depends upon the fill volume of the catheter, which is imprinted by the manufacturer on each catheter. Once the alcohol is in the catheter, the proximal end of the catheter will be clamped for 1 hour. After 1 hour dwell time, the clamp will be removed and catheter will be flushed out by the patient's own urine output.
124350|NCT01865084|B4|Baseline|Total|Total of all reporting groups
124351|NCT01865084|B3|Baseline|0.6 mg/kg Tadalafil|0.6 mg/kg tadalafil taken orally once daily.
124352|NCT01865084|B2|Baseline|0.3 mg/kg Tadalafil|0.3 milligram per kilogram (mg/kg) tadalafil taken orally once daily.
124353|NCT01865084|B1|Baseline|Placebo|Placebo taken orally once daily.
124354|NCT01865084|P3|Participant Flow|0.6 mg/kg Tadalafil|0.6 mg/kg tadalafil taken orally once daily.
124355|NCT01865084|P2|Participant Flow|0.3 mg/kg Tadalafil|0.3 milligram per kilogram (mg/kg) tadalafil taken orally once daily.
124356|NCT01865084|P1|Participant Flow|Placebo|Placebo taken orally once daily.
124357|NCT01865084|O1|Outcome|0.3 mg/kg Tadalafil and 0.6 mg/kg Tadalafil|"0.3 mg/kg tadalafil taken orally once daily.~0.6 mg/kg tadalafil taken orally once daily."
124358|NCT01865084|O3|Outcome|0.6 mg/kg Tadalafil|0.6 mg/kg tadalafil taken orally once daily.
124359|NCT01865084|O2|Outcome|0.3 mg/kg Tadalafil|0.3 mg/kg tadalafil taken orally once daily.
124360|NCT01865084|O1|Outcome|Placebo|Placebo taken orally once daily.
124361|NCT01865084|O3|Outcome|0.6 mg/kg Tadalafil|0.6 mg/kg tadalafil taken orally once daily.
124362|NCT01865084|O2|Outcome|0.3 mg/kg Tadalafil|0.3 mg/kg tadalafil taken orally once daily.
124363|NCT01865084|O1|Outcome|Placebo|Placebo taken orally once daily.
124364|NCT01865084|O3|Outcome|0.6 mg/kg Tadalafil|0.6 mg/kg tadalafil taken orally once daily.
124365|NCT01865084|O2|Outcome|0.3 mg/kg Tadalafil|0.3 mg/kg tadalafil taken orally once daily.
124366|NCT01865084|O1|Outcome|Placebo|Placebo taken orally once daily.
124367|NCT01865084|O3|Outcome|0.6 mg/kg Tadalafil|0.6 mg/kg tadalafil taken orally once daily.
124368|NCT01865084|O2|Outcome|0.3 mg/kg Tadalafil|0.3 mg/kg tadalafil taken orally once daily.
124369|NCT01865084|O1|Outcome|Placebo|Placebo taken orally once daily.
124370|NCT01865084|O3|Outcome|0.6 mg/kg Tadalafil|0.6 mg/kg tadalafil taken orally once daily.
124371|NCT01865084|O2|Outcome|0.3 mg/kg Tadalafil|0.3 mg/kg tadalafil taken orally once daily.
124372|NCT01865084|O1|Outcome|Placebo|Placebo taken orally once daily.
124381|NCT01864538|B1|Baseline|TH-302|"480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.~TH-302: 480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle."
124382|NCT01864538|P1|Participant Flow|TH-302|"480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.~TH-302: 480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle."
124383|NCT01864538|O1|Outcome|TH-302|"480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.~TH-302: 480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle."
124384|NCT01864538|E1|Reported Event|TH-302|"480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.~TH-302: 480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle."
124385|NCT01864434|B3|Baseline|Total|Total of all reporting groups
124386|NCT01864434|B2|Baseline|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.~Zimmer PCR TKA"
124387|NCT01864434|B1|Baseline|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.~Stryker PCR TKA"
124388|NCT01864434|P2|Participant Flow|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.~Zimmer PCR TKA"
124389|NCT01864434|P1|Participant Flow|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.~Stryker PCR TKA"
124390|NCT01864434|O2|Outcome|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.~Zimmer PCR TKA"
124391|NCT01864434|O1|Outcome|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.~Stryker PCR TKA"
124392|NCT01864434|O2|Outcome|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.~Zimmer PCR TKA"
124393|NCT01864434|O1|Outcome|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.~Stryker PCR TKA"
124394|NCT01864434|O2|Outcome|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.~Zimmer PCR TKA"
124395|NCT01864434|O1|Outcome|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.~Stryker PCR TKA"
124396|NCT01864434|E2|Reported Event|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.~Zimmer PCR TKA"
124397|NCT01864434|E1|Reported Event|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.~Stryker PCR TKA"
124398|NCT01864200|B3|Baseline|Total|Total of all reporting groups
124399|NCT01864200|B2|Baseline|Saline Placebo|"Saline placebo~Placebo"
124400|NCT01864200|B1|Baseline|CroFab|"Crotalidae Polyvalent Immune Fab (ovine) per approved labeling~Crotalidae Polyvalent Immune Fab (ovine): crotalidae antivenom"
124401|NCT01864200|P2|Participant Flow|Saline Placebo|"Saline placebo~Placebo"
124402|NCT01864200|P1|Participant Flow|CroFab|"crotilidae polyvalent immune fab (ovine) per approved labeling~crotilidae polyvalent immune fab (ovine): crotilidae antivenom"
124403|NCT01864200|O2|Outcome|Saline Placebo|"Saline placebo~Placebo"
124404|NCT01864200|O1|Outcome|CroFab|"crotilidae polyvalent immune fab (ovine) per approved labeling~crotilidae polyvalent immune fab (ovine): crotilidae antivenom"
124405|NCT01864200|E2|Reported Event|Saline Placebo|"Saline placebo~Placebo"
124406|NCT01864200|E1|Reported Event|CroFab|"crotilidae polyvalent immune fab (ovine) per approved labeling~crotilidae polyvalent immune fab (ovine): crotilidae antivenom"
124407|NCT01864174|B3|Baseline|Total|Total of all reporting groups
124408|NCT01864174|B2|Baseline|Metformin IR|"Participants received Metformin IR and Placebo matching with Metformin IR.~Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks~Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
124409|NCT01864174|B1|Baseline|Metformin XR|"Participants received Metformin XR and Placebo matching with Metformin XR~Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks~Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
124410|NCT01864174|P2|Participant Flow|Metformin IR|"Participants received Metformin IR and Placebo matching with Metformin IR.~Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks~Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
124411|NCT01864174|P1|Participant Flow|Metformin XR|"Participants received Metformin XR and Placebo matching with Metformin XR~Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks~Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
124412|NCT01864174|O2|Outcome|Metformin IR|"Participants received Metformin IR and Placebo matching with Metformin IR.~Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks~Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
124413|NCT01864174|O1|Outcome|Metformin XR|"Participants received Metformin XR and Placebo matching with Metformin XR~Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks~Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
124414|NCT01864174|O2|Outcome|Metformin IR|"Participants received Metformin IR and Placebo matching with Metformin IR.~Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks~Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
124415|NCT01864174|O1|Outcome|Metformin XR|"Participants received Metformin XR and Placebo matching with Metformin XR~Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks~Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
124416|NCT01864174|O2|Outcome|Metformin IR|"Participants received Metformin IR and Placebo matching with Metformin IR.~Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks~Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
124455|NCT01864148|E5|Reported Event|BIIB033 100 mg/kg|BIIB033 100 mg/kg once every 4 weeks IV infusion
124417|NCT01864174|O1|Outcome|Metformin XR|"Participants received Metformin XR and Placebo matching with Metformin XR~Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks~Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
124418|NCT01864174|O2|Outcome|Metformin IR|"Participants received Metformin IR and Placebo matching with Metformin IR.~Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks~Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
124419|NCT01864174|O1|Outcome|Metformin XR|"Participants received Metformin XR and Placebo matching with Metformin XR~Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks~Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
124420|NCT01864174|O2|Outcome|Metformin IR|"Participants received Metformin IR and Placebo matching with Metformin IR.~Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks~Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
124421|NCT01864174|O1|Outcome|Metformin XR|"Participants received Metformin XR and Placebo matching with Metformin XR~Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks~Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
124422|NCT01864174|E2|Reported Event|Metformin IR|"Participants received Metformin IR and Placebo matching with Metformin IR.~Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks~Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
124423|NCT01864174|E1|Reported Event|Metformin XR|"Participants received Metformin XR and Placebo matching with Metformin XR~Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks~Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
124424|NCT01864148|B6|Baseline|Total|Total of all reporting groups
124425|NCT01864148|B5|Baseline|BIIB033, 100 mg/kg|"BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124426|NCT01864148|B4|Baseline|BIIB033, 30 mg/kg|"BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124427|NCT01864148|B3|Baseline|BIIB033, 10 mg/kg|"BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124428|NCT01864148|B2|Baseline|BIIB033, 3 mg/kg|"BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124429|NCT01864148|B1|Baseline|Placebo|"Placebo once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124430|NCT01864148|P5|Participant Flow|BIIB033, 100 mg/kg|"BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124431|NCT01864148|P4|Participant Flow|BIIB033, 30 mg/kg|"BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124432|NCT01864148|P3|Participant Flow|BIIB033, 10 mg/kg|"BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124433|NCT01864148|P2|Participant Flow|BIIB033, 3 mg/kg|"BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124434|NCT01864148|P1|Participant Flow|Placebo|"Placebo once every 4 weeks intravenous (IV) infusion up to Week 72.~Avonex once-weekly intramuscular (IM) injection up to Week 84."
124435|NCT01864148|O4|Outcome|BIIB033, 100 mg/kg|"BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124436|NCT01864148|O3|Outcome|BIIB033, 30 mg/kg|"BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124437|NCT01864148|O2|Outcome|BIIB033, 10 mg/kg|"BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124438|NCT01864148|O1|Outcome|BIIB033, 3 mg/kg|"BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124439|NCT01864148|O6|Outcome|BIIB033 Total|BIIB033 3, 10, 30, or 100 mg/kg once every 4 weeks IV infusion
124440|NCT01864148|O5|Outcome|BIIB033, 100 mg/kg|"BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124441|NCT01864148|O4|Outcome|BIIB033, 30 mg/kg|"BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124442|NCT01864148|O3|Outcome|BIIB033, 10 mg/kg|"BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124443|NCT01864148|O2|Outcome|BIIB033, 3 mg/kg|"BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124444|NCT01864148|O1|Outcome|Placebo|"Placebo once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124445|NCT01864148|O5|Outcome|BIIB033, 100 mg/kg|"BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124446|NCT01864148|O4|Outcome|BIIB033, 30 mg/kg|"BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124447|NCT01864148|O3|Outcome|BIIB033, 10 mg/kg|"BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124448|NCT01864148|O2|Outcome|BIIB033, 3 mg/kg|"BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124449|NCT01864148|O1|Outcome|Placebo|"Placebo once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124450|NCT01864148|O5|Outcome|BIIB033, 100 mg/kg|"BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124451|NCT01864148|O4|Outcome|BIIB033, 30 mg/kg|"BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124452|NCT01864148|O3|Outcome|BIIB033, 10 mg/kg|"BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124453|NCT01864148|O2|Outcome|BIIB033, 3 mg/kg|"BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124454|NCT01864148|O1|Outcome|Placebo|"Placebo once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124459|NCT01864148|E1|Reported Event|Placebo|"Placebo once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
124460|NCT01864005|B3|Baseline|Total|Total of all reporting groups
124461|NCT01864005|B2|Baseline|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
124462|NCT01864005|B1|Baseline|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
124463|NCT01864005|P2|Participant Flow|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
124464|NCT01864005|P1|Participant Flow|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
124465|NCT01864005|O2|Outcome|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
124466|NCT01864005|O1|Outcome|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
124467|NCT01864005|O2|Outcome|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
124468|NCT01864005|O1|Outcome|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
124469|NCT01864005|O2|Outcome|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
124470|NCT01864005|O1|Outcome|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
124471|NCT01864005|O2|Outcome|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
124472|NCT01864005|O1|Outcome|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
124473|NCT01864005|O2|Outcome|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
124474|NCT01864005|O1|Outcome|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
124475|NCT01864005|E2|Reported Event|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
124476|NCT01864005|E1|Reported Event|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
124477|NCT01863953|B4|Baseline|Total|Total of all reporting groups
124478|NCT01863953|B3|Baseline|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
124479|NCT01863953|B2|Baseline|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
124480|NCT01863953|B1|Baseline|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
124481|NCT01863953|P3|Participant Flow|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
126431|NCT01854658|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
124482|NCT01863953|P2|Participant Flow|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
124483|NCT01863953|P1|Participant Flow|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
124484|NCT01863953|O3|Outcome|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
124485|NCT01863953|O2|Outcome|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
124486|NCT01863953|O1|Outcome|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
124487|NCT01863953|O3|Outcome|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
124488|NCT01863953|O2|Outcome|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
124489|NCT01863953|O1|Outcome|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
124490|NCT01863953|O3|Outcome|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
124491|NCT01863953|O2|Outcome|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
124492|NCT01863953|O1|Outcome|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
124493|NCT01863953|E3|Reported Event|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
124494|NCT01863953|E2|Reported Event|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
124495|NCT01863953|E1|Reported Event|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
124496|NCT01863771|B1|Baseline|All Participants|Participants who received golimumab 200 milligram (mg) once at Week 0 and golimumab 100 mg once at Week 2 subcutaneously (SC) in the induction phase.
124497|NCT01863771|P4|Participant Flow|Group 4: Golimumab 100 mg [Maintenance]|Participants who not responded to golimumab induction dosing received golimumab 100 mg SC once at Week 0 and once at Week 4, and based on clinical response every 4 weeks through Week 52.
124498|NCT01863771|P3|Participant Flow|Group 3: Placebo [Maintenance]|Participants who responded to golimumab induction treatment received placebo SC every 4 weeks (q4w) through Week 52.
124499|NCT01863771|P2|Participant Flow|Group 2: Golimumab 100 mg [Maintenance]|Participants who responded to golimumab induction treatment received golimumab 100 mg SC every 4 weeks (q4w) through Week 52.
124500|NCT01863771|P1|Participant Flow|Group1: Golimumab [Induction]|Participants received golimumab 200 milligram (mg) once at Week 0 and golimumab 100 mg once at Week 2 subcutaneously (SC).
124501|NCT01863771|O2|Outcome|Golimumab|Participants received golimumab 200 mg (once at Week 0) and golimumab 100 mg (once at Week 2) SC in induction phase. Participants who responded to golimumab induction treatment received golimumab 100 mg SC, q4w through Week 52 and participants who not responded to golimumab induction treatment received golimumab 100 mg SC at Weeks 0 and 4, and based on clinical response every 4 weeks through Week 52 in maintenance phase.
124502|NCT01863771|O1|Outcome|Placebo|Participants who responded to golimumab induction treatment received placebo subcutaneously (SC) every 4 weeks (q4w) through Week 52 in the maintenance phase.
124503|NCT01863771|O2|Outcome|Golimumab|Participants received golimumab 200 mg (once at Week 0) and golimumab 100 mg (once at Week 2) SC in induction phase. Participants who responded to golimumab induction treatment received golimumab 100 mg SC, q4w through Week 52 and participants who not responded to golimumab induction treatment received golimumab 100 mg SC at Weeks 0 and 4, and based on clinical response every 4 weeks through Week 52 in maintenance phase.
124504|NCT01863771|O1|Outcome|Placebo|Participants who responded to golimumab induction treatment received placebo subcutaneously (SC) every 4 weeks (q4w) through Week 52 in the maintenance phase.
124505|NCT01863771|O2|Outcome|Golimumab|Participants received golimumab 200 mg (once at Week 0) and golimumab 100 mg (once at Week 2) SC in induction phase. Participants who responded to golimumab induction treatment received golimumab 100 mg SC, q4w through Week 52 and participants who not responded to golimumab induction treatment received golimumab 100 mg SC at Weeks 0 and 4, and based on clinical response every 4 weeks through Week 52 in maintenance phase.
124506|NCT01863771|O1|Outcome|Placebo|Participants who responded to golimumab induction treatment received placebo subcutaneously (SC) every 4 weeks (q4w) through Week 52 in the maintenance phase.
124507|NCT01863771|E4|Reported Event|Group 4: Golimumab 100 mg [Maintenance]|Participants who not responded to golimumab induction dosing received golimumab 100 mg SC once at Week 0 and once at Week 4, and based on clinical response every 4 week through Week 52.
124508|NCT01863771|E3|Reported Event|Group 3: Placebo [Maintenance]|Participants who responded to golimumab induction treatment received placebo SC every 4 weeks (q4w) through Week 52.
124509|NCT01863771|E2|Reported Event|Group 2: Golimumab 100 mg [Maintenance]|Participants who responded to golimumab induction treatment received golimumab 100 mg SC every 4 weeks (q4w) through Week 52.
124510|NCT01863771|E1|Reported Event|Group1: Golimumab [Induction]|Participants received golimumab 200 milligram (mg) once at Week 0 and golimumab 100 mg once at Week 2 subcutaneously (SC).
124511|NCT01863758|B1|Baseline|Human-cl rhFVIII|Up to 60-80 IU/kg of intravenous human-cl rhFVIII (human cell line recombinant Factor VIII) was administered at an individually determined dose and dose interval.
124512|NCT01863758|P1|Participant Flow|Human-cl rhFVIII|Up to 60-80 IU/kg of intravenous human-cl rhFVIII (human cell line recombinant Factor VIII) was administered at an individually determined dose and dose interval.
124575|NCT01863368|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to exposure to investigational product
124513|NCT01863758|O1|Outcome|Human-cl rhFVIII|Up to 60-80 IU/kg of intravenous human-cl rhFVIII (human cell line recombinant Factor VIII) was administered at an individually determined dose and dose interval.
124514|NCT01863758|O1|Outcome|Human-cl rhFVIII|Up to 60-80 IU/kg of intravenous human-cl rhFVIII (human cell line recombinant Factor VIII) was administered at an individually determined dose and dose interval.
124515|NCT01863758|O1|Outcome|Human-cl rhFVIII|Up to 60-80 IU/kg of intravenous human-cl rhFVIII (human cell line recombinant Factor VIII) was administered at an individually determined dose and dose interval.
124516|NCT01863758|O1|Outcome|Human-cl rhFVIII|Up to 60-80 IU/kg of intravenous human-cl rhFVIII (human cell line recombinant Factor VIII) was administered at an individually determined dose and dose interval.
124517|NCT01863758|O1|Outcome|Human-cl rhFVIII|Up to 60-80 IU/kg of intravenous human-cl rhFVIII (human cell line recombinant Factor VIII) was administered at an individually determined dose and dose interval.
124518|NCT01863758|E1|Reported Event|Human-cl rhFVIII|All subject who received at least one dose of intravenous Human-cl rhFVIII (human cell line recombinant Factor VIII).
124519|NCT01863680|B1|Baseline|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.~Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro fertilization and embryo transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
124520|NCT01863680|P1|Participant Flow|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.~Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using Gonadotropin-releasing hormone (GnRH) analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
124521|NCT01863680|O1|Outcome|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.~Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
124522|NCT01863680|O1|Outcome|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.~Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
124523|NCT01863680|O1|Outcome|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.~Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
124524|NCT01863680|E1|Reported Event|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.~Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
124525|NCT01863667|B3|Baseline|Total|Total of all reporting groups
124526|NCT01863667|B2|Baseline|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
124527|NCT01863667|B1|Baseline|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
124528|NCT01863667|P2|Participant Flow|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
124529|NCT01863667|P1|Participant Flow|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
124530|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
124531|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
124532|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
124533|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
124534|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
124535|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
124536|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
124537|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
124538|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
124539|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
124540|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
124541|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
124542|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
124543|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
124544|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
124545|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
124546|NCT01863667|E2|Reported Event|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
124547|NCT01863667|E1|Reported Event|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
124548|NCT01863563|B1|Baseline|Quickclot|single arm
124549|NCT01863563|P1|Participant Flow|QuickClot|"QuickClot sponge will be applied for one minute each site of tonsillectomy and Adenoidectomy.~QuickClot: 1 application of treatment to each tonsil/adenoid removal area"
124550|NCT01863563|O1|Outcome|Cauterization Time|mean total cauterization time 155.3 seconds
124551|NCT01863563|E1|Reported Event|Adverse Events|defined as bleeding or dehydration requiring medical intervention
124552|NCT01863433|B1|Baseline|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
124553|NCT01863433|P1|Participant Flow|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
124554|NCT01863433|O1|Outcome|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
124555|NCT01863433|O1|Outcome|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
124556|NCT01863433|O1|Outcome|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
124557|NCT01863433|O1|Outcome|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
124558|NCT01863433|O1|Outcome|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
124559|NCT01863433|E1|Reported Event|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
124560|NCT01863368|B3|Baseline|Total|Total of all reporting groups
124561|NCT01863368|B2|Baseline|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
124562|NCT01863368|B1|Baseline|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
124563|NCT01863368|P2|Participant Flow|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
124564|NCT01863368|P1|Participant Flow|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
124565|NCT01863368|O2|Outcome|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
124566|NCT01863368|O1|Outcome|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
124567|NCT01863368|O2|Outcome|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
124568|NCT01863368|O1|Outcome|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
124569|NCT01863368|O2|Outcome|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
124570|NCT01863368|O1|Outcome|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
124571|NCT01863368|O2|Outcome|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
124572|NCT01863368|O1|Outcome|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
124573|NCT01863368|E3|Reported Event|Optive|All subjects who were exposed to Optive or run-in therapy
124574|NCT01863368|E2|Reported Event|Systane Ultra|All subjects who were exposed to Systane Ultra or run-in therapy
124577|NCT01863134|B2|Baseline|Eptifibatide|In the treatment group patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery). The minimal and maximal periods of eptifibatide infusion were established at 12 and 48 hours respectively.
124578|NCT01863134|B1|Baseline|Placebo/Control Group|In the control group patients were given identical doses of acetylsalicylic acid and enoxaparin followed by a placebo infusion of saline in lieu of the GPIIb/IIIa inhibitor.
124579|NCT01863134|P2|Participant Flow|Placebo|Patients were given placebo infusion (0,9% Natrium Chloride) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
124580|NCT01863134|P1|Participant Flow|Eptifibatide|Patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
124581|NCT01863134|O2|Outcome|Eptifibatide|Patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
124582|NCT01863134|O1|Outcome|Placebo|Patients were given placebo infusion (0,9% Natrium Chloride) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
124583|NCT01863134|E2|Reported Event|Placebo|Patients were given placebo infusion (0,9% Natrium Chloride) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
124584|NCT01863134|E1|Reported Event|Eptifibatide|Patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
124585|NCT01862991|B4|Baseline|Total|Total of all reporting groups
124586|NCT01862991|B3|Baseline|Mifepristone|"The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
124587|NCT01862991|B2|Baseline|Dilapan-Mifepristone|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
124588|NCT01862991|B1|Baseline|Dilapan-Placebo|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation"
124589|NCT01862991|P3|Participant Flow|Mifepristone|"The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
124590|NCT01862991|P2|Participant Flow|Dilapan-Mifepristone|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
124591|NCT01862991|P1|Participant Flow|Dilapan-Placebo|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation"
124592|NCT01862991|O3|Outcome|Mifepristone|"The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
124611|NCT01862419|B2|Baseline|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
124612|NCT01862419|B1|Baseline|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
124613|NCT01862419|P2|Participant Flow|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
126432|NCT01854658|O4|Outcome|Placebo MDI|Inhaled placebo administered as two puffs BID
124593|NCT01862991|O2|Outcome|Dilapan-Mifepristone|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
124594|NCT01862991|O1|Outcome|Dilapan-Placebo|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation"
124595|NCT01862991|O3|Outcome|Mifepristone|"The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
124596|NCT01862991|O2|Outcome|Dilapan-Mifepristone|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
124597|NCT01862991|O1|Outcome|Dilapan-Placebo|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation"
124598|NCT01862991|E3|Reported Event|Mifepristone|"The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
124599|NCT01862991|E2|Reported Event|Dilapan-Mifepristone|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
124600|NCT01862991|E1|Reported Event|Dilapan-Placebo|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation"
124601|NCT01862484|B3|Baseline|Total|Total of all reporting groups
124602|NCT01862484|B2|Baseline|Ruse Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet.~Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet"
124603|NCT01862484|B1|Baseline|Restricted Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.~Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet."
124604|NCT01862484|P2|Participant Flow|Ruse Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet.~Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet"
124605|NCT01862484|P1|Participant Flow|Restricted Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.~Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet."
124606|NCT01862484|O2|Outcome|Ruse Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet.~Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet"
124607|NCT01862484|O1|Outcome|Restricted Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.~Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet."
124608|NCT01862484|E2|Reported Event|Ruse Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet.~Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet"
124609|NCT01862484|E1|Reported Event|Restricted Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.~Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet."
124610|NCT01862419|B3|Baseline|Total|Total of all reporting groups
124663|NCT01861925|O1|Outcome|Normal Eye|Astigmatism smaller than 1.5 diopters
124614|NCT01862419|P1|Participant Flow|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
124615|NCT01862419|O2|Outcome|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
124616|NCT01862419|O1|Outcome|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
124617|NCT01862419|O2|Outcome|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
124618|NCT01862419|O1|Outcome|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
124619|NCT01862419|O2|Outcome|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
124620|NCT01862419|O1|Outcome|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
124621|NCT01862419|E2|Reported Event|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
124622|NCT01862419|E1|Reported Event|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
124623|NCT01862250|B1|Baseline|Clonidine Infants With HIE|"Infants in this group will receive Intravenous clonidine at 1µg/kg/dose either every 6 or 8 hrs from the start of cooling to the end of re-warming~Clonidine (Duraclon®): Clonidine at dosing intervals of 4, 6, 8, 12, 18 or 24 hours.~If the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.~10 mm Hg reduction in MAP or MAP ≤ 40 mm Hg sustained for ≥30 min after administration~20% drop in HR from the infant's baseline, sustained for ≥30 min after administration~HR ≤70/min, sustained for ≥30 min after administration"
124624|NCT01862250|P1|Participant Flow|Clonidine Infants With HIE|"Infants in this group will receive Intravenous clonidine at 1µg/kg/dose either every 6 or 8 hrs from the start of cooling to the end of re-warming~Clonidine (Duraclon®): Clonidine at dosing intervals of 6, 8, 12, 18 or 24 hours.~If the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.~10 mm Hg reduction in Mean Arterial Pressure (MAP) or MAP ≤ 40 mm Hg sustained for ≥30 min after administration~20% drop in Heart Rate (HR) from the infant's baseline, sustained for ≥30 min after administration~HR ≤70/min, sustained for ≥30 min after administration"
124625|NCT01862250|O1|Outcome|Clonidine Infants With HIE|"Infants in this group will receive Intravenous clonidine at 1µg/kg/dose either every 6 or 8 hrs from the start of cooling to the end of re-warming~Clonidine (Duraclon®): Clonidine at dosing intervals of 4, 6, 8, 12, 18 or 24 hours.~If the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.~10 mm Hg reduction in MAP or MAP ≤ 40 mm Hg sustained for ≥30 min after administration~20% drop in HR from the infant's baseline, sustained for ≥30 min after administration~HR ≤70/min, sustained for ≥30 min after administration"
124626|NCT01862250|O1|Outcome|Clonidine Infants With HIE|"Infants in this group will receive Intravenous clonidine at 1µg/kg/dose either every 6 or 8 hrs from the start of cooling to the end of re-warming~Clonidine (Duraclon®): Clonidine at dosing intervals of 4, 6, 8, 12, 18 or 24 hours.~If the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.~10 mm Hg reduction in MAP or MAP ≤ 40 mm Hg sustained for ≥30 min after administration~20% drop in HR from the infant's baseline, sustained for ≥30 min after administration~HR ≤70/min, sustained for ≥30 min after administration"
124627|NCT01862250|O1|Outcome|Clonidine Infants With HIE|"Infants in this group will receive Intravenous clonidine at 1µg/kg/dose either every 6 or 8 hrs from the start of cooling to the end of re-warming~Clonidine (Duraclon®): Clonidine at dosing intervals of 4, 6, 8, 12, 18 or 24 hours.~If the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.~10 mm Hg reduction in MAP or MAP ≤ 40 mm Hg sustained for ≥30 min after administration~20% drop in HR from the infant's baseline, sustained for ≥30 min after administration~HR ≤70/min, sustained for ≥30 min after administration"
124628|NCT01862250|O1|Outcome|Clonidine Infants With HIE|"Infants in this group will receive Intravenous clonidine at 1µg/kg/dose either every 6 or 8 hrs from the start of cooling to the end of re-warming~Clonidine (Duraclon®): Clonidine at dosing intervals of 4, 6, 8, 12, 18 or 24 hours.~If the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.~10 mm Hg reduction in MAP or MAP ≤ 40 mm Hg sustained for ≥30 min after administration~20% drop in HR from the infant's baseline, sustained for ≥30 min after administration~HR ≤70/min, sustained for ≥30 min after administration"
124629|NCT01862250|E1|Reported Event|Clonidine Infants With HIE|"Infants in this group will receive Intravenous clonidine at 1µg/kg/dose either every 6 or 8 hrs from the start of cooling to the end of re-warming~Clonidine (Duraclon®): Clonidine at dosing intervals of 4, 6, 8, 12, 18 or 24 hours.~If the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.~10 mm Hg reduction in MAP or MAP ≤ 40 mm Hg sustained for ≥30 min after administration~20% drop in HR from the infant's baseline, sustained for ≥30 min after administration~HR ≤70/min, sustained for ≥30 min after administration"
124630|NCT01862159|B1|Baseline|Operated Patients|All patients operated with a laparoscopic gastric bypass procedure in Sweden during the inclusion period.
124631|NCT01862159|P1|Participant Flow|Operated Patients|"Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012~laparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery"
124632|NCT01862159|O1|Outcome|Operated Patients|"Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012~laparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery"
124633|NCT01862159|O1|Outcome|Operated Patients|"Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012~laparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery"
124634|NCT01862159|O1|Outcome|Operated Patients|"Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012~laparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery"
124635|NCT01862159|O1|Outcome|Operated Patients|"Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012~laparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery"
124636|NCT01862159|E1|Reported Event|Operated Patients|"Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012~laparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery"
124637|NCT01862133|B1|Baseline|Patient Preferences|Patients were eligible if they had visited their primary care physician at least twice in the previous 1 year and were fluent in English. Each patient subject used an online program to record their preferences what each of their providers can see. The electronic medical record (EMR) will then apply them to data displays.
124638|NCT01862133|P2|Participant Flow|Primary Care Providers|"All healthcare providers (physicians, nurses, and other clinic staff) were eligible to participate in this study. For those enrolled, display of patient data in the EMR was dictated by the patient subject's preferences for who should see what data.~Patient preferences: Software for recording patients' preferences for which providers see which parts of their EMRs, and EMR software for restricting access to data based on patients' preferences.~11 physicians and 23 additional clinic staff (5 nurses, 4 clinical nurse assistants, 3 physicians' assistants, 2 nurse practitioners, and 9 medical assistance worked in the study primary care clinic at the time of the study~2 physicians were excluded because their patients were mainly Spanish speaking~1 physician verbally agreed to be in the study but never signed the informed consent statement~8 physicians and all 23 of the other clinic staff were enrolled and signed informed consent statements and completed in the study"
124639|NCT01862133|P1|Participant Flow|Patient Preferences|"Patients were eligible if they had visited their primary care physician at least twice in the previous 1 year and were fluent in English. Each patient subject used an online program to record their preferences what each of their providers can see. The electronic medical record (EMR) will then apply them to data displays.~141 adult primary care clinic patients were approached 38 refused to participate 107 were enrolled and signed informed consent statements 2 failed to complete the patient preference dialog and study questionnaire 105 completed the patient preference dialog and were included in the study 92 subjects returned to the clinic during the 6-month study"
124640|NCT01862133|O2|Outcome|Primary Care Providers|"All healthcare providers (physicians, nurses, and other clinic staff) were eligible to participate in this study. For those enrolled, display of patient data in the EMR was dictated by the patient subject's preferences for who should see what data.~Patient preferences: Software for recording patients' preferences for which providers see which parts of their EMRs, and EMR software for restricting access to data based on patients' preferences.~11 physicians and 23 additional clinic staff (5 nurses, 4 clinical nurse assistants, 3 physicians' assistants, 2 nurse practitioners, and 9 medical assistance worked in the study primary care clinic at the time of the study~2 physicians were excluded because their patients were mainly Spanish speaking~1 physician verbally agreed to be in the study but never signed the informed consent statement~8 physicians and all 23 of the other clinic staff were enrolled and signed informed consent statements and completed in the study~24"
124641|NCT01862133|O1|Outcome|Patient Preferences|"Patients were eligible if they had visited their primary care physician at least twice in the previous 1 year and were fluent in English. Each patient subject used an online program to record their preferences what each of their providers can see. The electronic medical record (EMR) will then apply them to data displays.~141 adult primary care clinic patients were approached 38 refused to participate 107 were enrolled and signed informed consent statements 2 failed to complete the patient preference dialog and study questionnaire 105 completed the patient preference dialog and were included in the study 92 subjects returned to the clinic during the 6-month study"
124642|NCT01862133|E2|Reported Event|Primary Care Providers|"All healthcare providers (physicians, nurses, and other clinic staff) were eligible to participate in this study. For those enrolled, display of patient data in the EMR was dictated by the patient subject's preferences for who should see what data.~Patient preferences: Software for recording patients' preferences for which providers see which parts of their EMRs, and EMR software for restricting access to data based on patients' preferences."
124643|NCT01862133|E1|Reported Event|Patient Preferences|Patients were eligible if they had visited their primary care physician at least twice in the previous 1 year and were fluent in English. Each patient subject used an online program to record their preferences what each of their providers can see. The electronic medical record (EMR) will then apply them to data displays.
124644|NCT01861925|B4|Baseline|Total|Total of all reporting groups
124645|NCT01861925|B3|Baseline|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
124646|NCT01861925|B2|Baseline|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
124647|NCT01861925|B1|Baseline|Normal Eye|Astigmatism smaller than 1.5 diopters
124648|NCT01861925|P3|Participant Flow|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
124649|NCT01861925|P2|Participant Flow|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
124650|NCT01861925|P1|Participant Flow|Normal Eye|Astigmatism smaller than 1.5 diopters
124651|NCT01861925|O1|Outcome|Regular Eye|"Astigmatism smaller than 1.5 diopters and regular astigmatism >= 1.5 diopters (group normal eye and large regular astigmatism)"
124652|NCT01861925|O3|Outcome|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
124653|NCT01861925|O2|Outcome|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
124654|NCT01861925|O1|Outcome|Normal Eye|Astigmatism smaller than 1.5 diopters
124655|NCT01861925|O3|Outcome|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
124656|NCT01861925|O2|Outcome|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
124657|NCT01861925|O1|Outcome|Normal Eye|Astigmatism smaller than 1.5 diopters
124658|NCT01861925|O3|Outcome|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
124659|NCT01861925|O2|Outcome|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
124660|NCT01861925|O1|Outcome|Normal Eye|Astigmatism smaller than 1.5 diopters
124661|NCT01861925|O3|Outcome|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
124662|NCT01861925|O2|Outcome|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
124664|NCT01861925|O3|Outcome|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
124665|NCT01861925|O2|Outcome|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
124666|NCT01861925|O1|Outcome|Normal Eye|Astigmatism smaller than 1.5 diopters
124667|NCT01861925|E3|Reported Event|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
124668|NCT01861925|E2|Reported Event|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
124669|NCT01861925|E1|Reported Event|Normal Eye|Astigmatism smaller than 1.5 diopters
124670|NCT01861756|B3|Baseline|Total|Total of all reporting groups
124671|NCT01861756|B2|Baseline|Usual Care|
124672|NCT01861756|B1|Baseline|Diabetes Medication Choice Decision Aid|
124673|NCT01861756|P2|Participant Flow|Usual Care|
124674|NCT01861756|P1|Participant Flow|Diabetes Medication Choice Decision Aid|
124675|NCT01861756|O2|Outcome|Usual Care|
124676|NCT01861756|O1|Outcome|Diabetes Medication Choice Decision Aid|
124677|NCT01861756|E2|Reported Event|Usual Care|
124678|NCT01861756|E1|Reported Event|Diabetes Medication Choice Decision Aid|
124679|NCT01861704|B3|Baseline|Total|Total of all reporting groups
124680|NCT01861704|B2|Baseline|Lyric2|"Lyric2 (Barracuda) device~Lyric: Extended wear hearing instrument"
124681|NCT01861704|B1|Baseline|Lyric|"Silver Lyric device~Lyric: Extended wear hearing instrument"
124682|NCT01861704|P2|Participant Flow|Lyric2|"Lyric2 (Barracuda) device~Lyric: Extended wear hearing instrument"
124683|NCT01861704|P1|Participant Flow|Lyric|"Silver Lyric device~Lyric: Extended wear hearing instrument"
124684|NCT01861704|O2|Outcome|Lyric2|"Lyric2 (Barracuda) device~Lyric: Extended wear hearing instrument~Only experienced ears counted"
124685|NCT01861704|O1|Outcome|Lyric|"Silver Lyric device~Lyric: Extended wear hearing instrument~Only experienced ears counted"
124686|NCT01861704|E2|Reported Event|Lyric2|"Lyric2 (Barracuda) device~Lyric: Extended wear hearing instrument"
124687|NCT01861704|E1|Reported Event|Lyric|"Silver Lyric device~Lyric: Extended wear hearing instrument"
124688|NCT01861665|B3|Baseline|Total|Total of all reporting groups
124689|NCT01861665|B2|Baseline|Medication Pre Incision Right Med Post Incision Left|Participants acted as their own control with right side being injected with medication pre incision and left side being injected with medication post incision.
124690|NCT01861665|B1|Baseline|Medication Pre Incision Left Med Post Incision Right|Participants acted as their own control with left side being injected with medication pre incision and right side being injected with medication post incision.
124691|NCT01861665|P2|Participant Flow|Medication Pre Incision Right Med Post Incision Left|Subjects acted as their own control with right side being injected with the medication pre incision and left side being injected with the medication post incision.
124692|NCT01861665|P1|Participant Flow|Medication Pre Incision Left Med Post Incision Right|Subjects acted as their own control with the left side being injected with the medication pre incision and the right side being injected with medication post incision.
124693|NCT01861665|O2|Outcome|Marcaine Administered Post Incision|"Post-operative administration, using both the specific drug - Marcaine 0.25%- and total amount - 5cc post incision.~Marcaine- 0.25%: Marcaine 0.25% administered post-incision."
124694|NCT01861665|O1|Outcome|Marcaine Administered Pre-incision|"Pre-operative administration, using both the specific drug - Marcaine 0.25%- and total amount - 5cc per incision.~Marcaine- 0.25%: Marcaine 0.25% administered pre-incision."
124695|NCT01861665|E2|Reported Event|Marcaine Administered Post-incision|"Marcaine 0.25% administered post-incision, total amount 5cc per incision.~Marcaine 0.25%.: Marcaine 0.25% administered post-incision."
124696|NCT01861665|E1|Reported Event|Marcaine Administered Pre-incision.|"Pre-operative administration, using both the specific drug - Marcaine 0.25%- and total amount - 5cc per incision.~Marcaine- 0.25%: Marcaine 0.25% administered pre-incision."
124697|NCT01861522|B3|Baseline|Total|Total of all reporting groups
124698|NCT01861522|B2|Baseline|Placebo|TAU-284 placebo twice daily for 2 weeks
124699|NCT01861522|B1|Baseline|TAU-284|TAU-284 10mg twice daily for 2 weeks
124700|NCT01861522|P2|Participant Flow|Placebo|TAU-284 placebo twice daily for 2 weeks
124701|NCT01861522|P1|Participant Flow|TAU-284|TAU-284 10mg twice daily for 2 weeks
124702|NCT01861522|O2|Outcome|Placebo|TAU-284 placebo twice daily for 2 weeks
124703|NCT01861522|O1|Outcome|TAU-284|TAU-284 10mg twice daily for 2 weeks
124704|NCT01861522|E2|Reported Event|Placebo|TAU-284 placebo twice daily for 2 weeks
124705|NCT01861522|E1|Reported Event|TAU-284|TAU-284 10mg twice daily for 2 weeks
124706|NCT01861457|B3|Baseline|Total|Total of all reporting groups
124707|NCT01861457|B2|Baseline|Saline Placebo|"Apply 4 rotations of swab to each nostril 3x in a 10-hour study period.~Placebo"
124708|NCT01861457|B1|Baseline|Nozin Nasal Sanitizer|"Apply 4 rotations of swab to each nostril 3x in a 10-hour study period.~Nozin Nasal Sanitizer"
124709|NCT01861457|P2|Participant Flow|Phosphate-buffered Saline (PBS) Placebo|Participants undergo three nasal vestibular applications of the PBS placebo using a saturated nasal swab at 4-hour intervals during the 10-hour study period.
124710|NCT01861457|P1|Participant Flow|Nozin® Nasal Sanitizer®|Participants undergo three nasal vestibular applications of the alcohol-based antiseptic using a saturated nasal swab at 4-hour intervals during the 10-hour study period.
124711|NCT01861457|O2|Outcome|Placebo|Participants known to exhibit Staph aureus carriage by previous nasal swab screening and randomly assigned received application of placebo treatment with phosphate-buffered saline at 0, 4 and 8 hrs.
124712|NCT01861457|O1|Outcome|Alcohol-Based Nasal Antiseptic|Participants known to exhibit Staph aureus carriage by previous nasal swab screening and randomly assigned received application by nasal swab of alcohol-based nasal antiseptic (Nozin® Nasal Sanitizer®) at 0, 4 and 8 hrs.
124713|NCT01861457|O2|Outcome|Placebo|Participants known to exhibit Staph aureus carriage by previous nasal swab screening and randomly assigned received application of placebo treatment with phosphate-buffered saline at 0, 4 and 8 hrs.
124762|NCT01860846|O1|Outcome|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
124714|NCT01861457|O1|Outcome|Alcohol-Based Nasal Antiseptic|Participants known to exhibit Staph aureus carriage by previous nasal swab screening and randomly assigned received application by nasal swab of alcohol-based nasal antiseptic (Nozin® Nasal Sanitizer®) at 0, 4 and 8 hrs.
124715|NCT01861457|E2|Reported Event|Sham|"Apply 4 rotations of swab to each nostril every four hours ...~Sham"
124716|NCT01861457|E1|Reported Event|Nozin Nasal Sanitizer|"Apply 4 rotations of swab to each nostril every four hours~Nozin Nasal Sanitizer"
124717|NCT01861301|B1|Baseline|Treatment (Tivantinib)|Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
124718|NCT01861301|P1|Participant Flow|Treatment (Tivantinib)|Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
124719|NCT01861301|O1|Outcome|Treatment (Tivantinib)|Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
124720|NCT01861301|O1|Outcome|Treatment (Tivantinib)|Patients receive tivantinib 360 PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
124721|NCT01861301|O1|Outcome|Treatment (Tivantinib)|Patients receive tivantinib 360 PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
124722|NCT01861301|O1|Outcome|Treatment (Tivantinib)|Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
124723|NCT01861301|E1|Reported Event|Treatment (Tivantinib)|Patients receive tivantinib 360 PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
124724|NCT01860989|B1|Baseline|Total - Cohort 1|Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
124725|NCT01860989|P1|Participant Flow|Total - Cohort 1|Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
124726|NCT01860989|O1|Outcome|Total - Cohort 1|Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
124727|NCT01860989|E1|Reported Event|Total - Cohort 1|Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
124728|NCT01860976|B3|Baseline|Total|Total of all reporting groups
124729|NCT01860976|B2|Baseline|Placebo|Placebo, self-administered subcutaneously, once weekly.
124730|NCT01860976|B1|Baseline|Abatacept|Abatacept 125mg, self-administered subcutaneously, once weekly
124731|NCT01860976|P2|Participant Flow|Placebo|Placebo, self-administered subcutaneously, once weekly.
124732|NCT01860976|P1|Participant Flow|Abatacept|Abatacept 125mg, self-administered subcutaneously, once weekly
124733|NCT01860976|O2|Outcome|Placebo|Placebo, self-administered subcutaneously, once weekly.
124734|NCT01860976|O1|Outcome|Abatacept|Abatacept 125mg, self-administered subcutaneously, once weekly
124735|NCT01860976|O2|Outcome|Placebo|Placebo, self-administered subcutaneously, once weekly.
124736|NCT01860976|O1|Outcome|Abatacept|Abatacept 125mg, self-administered subcutaneously, once weekly
124737|NCT01860976|O2|Outcome|Placebo|Placebo, self-administered subcutaneously, once weekly.
124738|NCT01860976|O1|Outcome|Abatacept|Abatacept 125mg, self-administered subcutaneously, once weekly
124739|NCT01860976|O2|Outcome|Placebo|Placebo, self-administered subcutaneously, once weekly.
124740|NCT01860976|O1|Outcome|Abatacept|Abatacept 125mg, self-administered subcutaneously, once weekly
124741|NCT01860976|O2|Outcome|Placebo|Placebo, self-administered subcutaneously, once weekly.
124742|NCT01860976|O1|Outcome|Abatacept|Abatacept 125mg, self-administered subcutaneously, once weekly
124743|NCT01860976|O2|Outcome|Placebo|Placebo, self-administered subcutaneously, once weekly.
124744|NCT01860976|O1|Outcome|Abatacept|Abatacept 125mg, self-administered subcutaneously, once weekly
124745|NCT01860976|O2|Outcome|Placebo|Placebo, self-administered subcutaneously, once weekly.
124746|NCT01860976|O1|Outcome|Abatacept|Abatacept 125mg, self-administered subcutaneously, once weekly
124747|NCT01860976|O2|Outcome|Placebo|Placebo, self-administered subcutaneously, once weekly.
124748|NCT01860976|O1|Outcome|Abatacept|Abatacept 125mg, self-administered subcutaneously, once weekly
124749|NCT01860976|O2|Outcome|Placebo|Placebo, self-administered subcutaneously, once weekly.
124750|NCT01860976|O1|Outcome|Abatacept|Abatacept 125mg, self-administered subcutaneously, once weekly
124751|NCT01860976|E2|Reported Event|PLACEBO|
124752|NCT01860976|E1|Reported Event|SC ABATACEPT|
124753|NCT01860846|B1|Baseline|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
124754|NCT01860846|P1|Participant Flow|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
124755|NCT01860846|O1|Outcome|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
124756|NCT01860846|O1|Outcome|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
124757|NCT01860846|O1|Outcome|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
124758|NCT01860846|O1|Outcome|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
124759|NCT01860846|O1|Outcome|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
124760|NCT01860846|O1|Outcome|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
124761|NCT01860846|O1|Outcome|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
124824|NCT01860573|O2|Outcome|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth~Amino acids"
124763|NCT01860846|E1|Reported Event|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
124764|NCT01860703|B1|Baseline|All Subjects|Subjects in this cross-over study all received one dose of each the following: A) a maximum therapeutic dose of 33 mg deferiprone, B) a supratherapeutic dose of 50 mg/kg deferiprone, C) placebo, and D) moxifloxacin (active control). They were randomized to receive these products in different orders: ABCD, BDAC, CADB, or DCBA. Treatments were separated by a 7-day washout period.
124765|NCT01860703|P4|Participant Flow|DCBA|"All subjects received the same 4 treatments, separated by at least 7 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment D = single oral dose of moxifloxacin Treatment C = single oral dose of placebo Treatment B = single oral dose of 50 mg/kg deferiprone Treatment A = single oral dose of 33 mg/kg deferiprone"
124766|NCT01860703|P3|Participant Flow|CADB|"All subjects received the same 4 treatments, separated by at least 7 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment C = single oral dose of placebo Treatment A = single oral dose of 33 mg/kg deferiprone Treatment D = single oral dose of moxifloxacin Treatment B = single oral dose of 50 mg/kg deferiprone"
124767|NCT01860703|P2|Participant Flow|BDAC|"All subjects received the same 4 treatments, separated by at least 7 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment B = single oral dose of 50 mg/kg deferiprone Treatment D = single oral dose of moxifloxacin Treatment A = single oral dose of 33 mg/kg deferiprone Treatment C = single oral dose of placebo"
124768|NCT01860703|P1|Participant Flow|ABCD|"All subjects received the same 4 treatments, separated by at least 7 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment A = single oral dose of 33 mg/kg deferiprone Treatment B = single oral dose of 50 mg/kg deferiprone Treatment C = single oral dose of placebo Treatment D = single oral dose of moxifloxacin"
124769|NCT01860703|O2|Outcome|Placebo Control|A single dose of deferiprone -matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
124770|NCT01860703|O1|Outcome|Positive Control|A single 400 mg tablet of moxifloxacin. The tablet was administered orally with approximately 240 mL of water.
124771|NCT01860703|O4|Outcome|Arm D - Positive Control|One 400 mg moxifloxacin tablet. Subjects additionally received a single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Tablets were administered orally with approximately 240 mL of water.
124772|NCT01860703|O3|Outcome|Arm C - Placebo Control|A single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
124773|NCT01860703|O2|Outcome|Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
124774|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
124775|NCT01860703|O4|Outcome|Arm D - Positive Control|One 400 mg moxifloxacin tablet. Subjects additionally received a single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Tablets were administered orally with approximately 240 mL of water.
124776|NCT01860703|O3|Outcome|Arm C - Placebo Control|A single dose of deferiprone -matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
124777|NCT01860703|O2|Outcome|Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
124778|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
124779|NCT01860703|O2|Outcome|Placebo Control|A single dose of deferiprone -matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
124780|NCT01860703|O1|Outcome|50 mg/kg Deferiprone|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
124781|NCT01860703|O2|Outcome|Treatment Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
124782|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
124783|NCT01860703|O2|Outcome|Treatment Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
124784|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
124785|NCT01860703|O2|Outcome|Treatment Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
124786|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
124787|NCT01860703|O2|Outcome|Treatment Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
124788|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
124789|NCT01860703|O4|Outcome|Arm D - Positive Control|One 400 mg moxifloxacin tablet. Subjects additionally received a single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Tablets were administered orally with approximately 240 mL of water.
124790|NCT01860703|O3|Outcome|Arm C - Placebo Control|A single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
124791|NCT01860703|O2|Outcome|Treatment Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
124792|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
124793|NCT01860703|O2|Outcome|Placebo Control|A single dose of deferiprone -matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
124794|NCT01860703|O1|Outcome|33 mg/kg Deferiprone|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
124795|NCT01860703|E4|Reported Event|Treatment Arm D - Positive Control|"Single dose of deferiprone matching placebo tablets and one 400 mg moxifloxacin tablet.~Deferiprone~moxifloxacin"
124796|NCT01860703|E3|Reported Event|Treatment Arm C - Placebo Control|"Single dose of deferiprone matching placebo tablets and one moxifloxacin matching placebo tablet.~deferiprone matching placebo tablets~moxifloxacin matching placebo tablet"
124797|NCT01860703|E2|Reported Event|Treatment Arm B - Supratherapeutic Dose|"Single dose of 50 mg/kg rounded to the nearest 250 mg of deferiprone tablets, and one moxifloxacin matching placebo tablet.~Deferiprone~moxifloxacin matching placebo tablet"
124798|NCT01860703|E1|Reported Event|Treatment Arm A - Maximum Therapeutic Dose|"Single dose of 33 mg/kg rounded to the nearest 250 mg of deferiprone tablets, deferiprone matching placebo tablets and one moxifloxacin matching placebo tablet.~Deferiprone~deferiprone matching placebo tablets~moxifloxacin matching placebo tablet"
124799|NCT01860677|B1|Baseline|All Study Participants|All of the study participants
124800|NCT01860677|P2|Participant Flow|Sham First, Then Active|"Sham first, then Active treatment~Active:~The Fisher Wallace Cranial Electrostimulation device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.~Fisher Wallace Cranial Stimulator~Sham:~Participants are outfitted with a device that is identical to the Fisher Wallace Cranial Stimulator in appearance but does not deliver any current.~Fisher Wallace Cranial Stimulator: The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies."
124801|NCT01860677|P1|Participant Flow|Active First, Then Sham|"Active treatment first, then Sham~Active:~The Fisher Wallace Cranial Electrostimulation device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.~Fisher Wallace Cranial Stimulator~Sham:~Participants are outfitted with a device that is identical to the Fisher Wallace Cranial Stimulator in appearance but does not deliver any current.~Fisher Wallace Cranial Stimulator: The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies."
124825|NCT01860573|O1|Outcome|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day~Amino acids"
124826|NCT01860573|O2|Outcome|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth~Amino acids"
124802|NCT01860677|O1|Outcome|Active Stimulation|"The Fisher Wallace Cranial Electrostimulation device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.~Fisher Wallace Cranial Stimulator"
124803|NCT01860677|O1|Outcome|Active Stimulation|"The Fisher Wallace Cranial Electrostimulation device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.~Fisher Wallace Cranial Stimulator"
124804|NCT01860677|O1|Outcome|Active Stimulation|"The Fisher Wallace Cranial Electrostimulation device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.~Fisher Wallace Cranial Stimulator"
124805|NCT01860677|O2|Outcome|Sham Stimulation|"Participants are outfitted with a device that is identical to the Fisher Wallace Cranial Stimulator in appearance but does not deliver any current.~Fisher Wallace Cranial Stimulator: The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies."
124806|NCT01860677|O1|Outcome|Active Stimulation|"The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.~Fisher Wallace Cranial Stimulator: The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies."
124807|NCT01860677|E2|Reported Event|Sham Stimulation|Participants are outfitted with a device that is identical in appearance but does not deliver any current.
124808|NCT01860677|E1|Reported Event|Active Stimulation|"The Fisher Wallace Cranial Electrostimulation device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.~Fisher Wallace Cranial Stimulator"
124809|NCT01860586|B1|Baseline|Bevacizumab|"Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)~Bevacizumab: .05 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3."
124810|NCT01860586|P1|Participant Flow|Bevacizumab|"Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)~Bevacizumab: .05 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3."
124811|NCT01860586|O1|Outcome|Bevacizumab|"Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)~Bevacizumab: .05 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3."
124812|NCT01860586|O1|Outcome|Bevacizumab|"Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)~Bevacizumab: .05 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3."
124813|NCT01860586|O1|Outcome|Bevacizumab|"Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)~Bevacizumab: .005 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3."
124814|NCT01860586|E1|Reported Event|Bevacizumab|"Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)~Bevacizumab: .05 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3."
124815|NCT01860573|B3|Baseline|Total|Total of all reporting groups
124816|NCT01860573|B2|Baseline|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth~Amino acids"
124817|NCT01860573|B1|Baseline|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day~Amino acids"
124818|NCT01860573|P2|Participant Flow|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth~Amino acids"
124819|NCT01860573|P1|Participant Flow|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day~Amino acids"
124820|NCT01860573|O2|Outcome|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth~Amino acids"
124821|NCT01860573|O1|Outcome|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day~Amino acids"
124822|NCT01860573|O2|Outcome|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth~Amino acids"
124823|NCT01860573|O1|Outcome|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day~Amino acids"
125060|NCT01859637|O1|Outcome|Zarzio®/Filgrastim HEXAL®|All patients received open-label Zarzio®/Filgrastim HEXAL®
124827|NCT01860573|O1|Outcome|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day~Amino acids"
124828|NCT01860573|O2|Outcome|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth~Amino acids"
124829|NCT01860573|O1|Outcome|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day~Amino acids"
124830|NCT01860573|O2|Outcome|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth~Amino acids"
124831|NCT01860573|O1|Outcome|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day~Amino acids"
124832|NCT01860573|O2|Outcome|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth~Amino acids"
124833|NCT01860573|O1|Outcome|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day~Amino acids"
124834|NCT01860573|E2|Reported Event|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth~Amino acids"
124835|NCT01860573|E1|Reported Event|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day~Amino acids"
124836|NCT01860534|B3|Baseline|Total|Total of all reporting groups
124837|NCT01860534|B2|Baseline|no Eye Patches Initially Then Eye Patches|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group B was unpatched for their first ROP exam and patched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
124838|NCT01860534|B1|Baseline|Eye Patches Initially Then no Patches|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
124839|NCT01860534|P2|Participant Flow|no Eye Patches Initially Then Eye Patches|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group B was unpatched for their first ROP exam and patched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care. Two groups were created to ensure comparison of similar gestational ages at the time of initial and secondary exams as younger neonates are often more ill. This added control was to minimize confounding by age or illness.
124840|NCT01860534|P1|Participant Flow|Eye Patch Initially Then no Eye Patch|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care. Two groups were created to ensure comparison of similar gestational ages at the time of initial and secondary exams as younger neonates are often more ill. This added control was to minimize confounding by age or illness.
124841|NCT01860534|O2|Outcome|no Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
124842|NCT01860534|O1|Outcome|Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
124843|NCT01860534|O2|Outcome|no Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
124844|NCT01860534|O1|Outcome|Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
124845|NCT01860534|O2|Outcome|no Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
124846|NCT01860534|O1|Outcome|Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
124847|NCT01860534|O2|Outcome|no Eye Patches Covers (ROP #1 and ROP #2)|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
124848|NCT01860534|O1|Outcome|Eye Patches Covers (ROP #1 and ROP #2)|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
124849|NCT01860534|E2|Reported Event|no Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
124850|NCT01860534|E1|Reported Event|Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
124851|NCT01860521|B3|Baseline|Total|Total of all reporting groups
124852|NCT01860521|B2|Baseline|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
124853|NCT01860521|B1|Baseline|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
124854|NCT01860521|P2|Participant Flow|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
124855|NCT01860521|P1|Participant Flow|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
124856|NCT01860521|O2|Outcome|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
124857|NCT01860521|O1|Outcome|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
124858|NCT01860521|O2|Outcome|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
124859|NCT01860521|O1|Outcome|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
124860|NCT01860521|O2|Outcome|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
124861|NCT01860521|O1|Outcome|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
124862|NCT01860521|O2|Outcome|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
124863|NCT01860521|O1|Outcome|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
124864|NCT01860521|E2|Reported Event|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
124905|NCT01859988|B4|Baseline|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
126433|NCT01854658|O3|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
124865|NCT01860521|E1|Reported Event|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
124866|NCT01860170|B4|Baseline|Total|Total of all reporting groups
124867|NCT01860170|B3|Baseline|Cohort 3-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 3-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
124868|NCT01860170|B2|Baseline|Cohort 2-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 2-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
124869|NCT01860170|B1|Baseline|Cohort 1-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 1-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
124870|NCT01860170|P3|Participant Flow|Cohort 3-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 3-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
124871|NCT01860170|P2|Participant Flow|Cohort 2-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 2-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
124872|NCT01860170|P1|Participant Flow|Cohort 1-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 1-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
124873|NCT01860170|O3|Outcome|Cohort 3-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 3-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
124906|NCT01859988|B3|Baseline|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
124909|NCT01859988|P6|Participant Flow|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
124874|NCT01860170|O2|Outcome|Cohort 2-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 2-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
124875|NCT01860170|O1|Outcome|Cohort 1-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 1-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
124876|NCT01860170|O3|Outcome|Cohort 3-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 3-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
124877|NCT01860170|O2|Outcome|Cohort 2-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 2-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
124878|NCT01860170|O1|Outcome|Cohort 1-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 1-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
124879|NCT01860170|O3|Outcome|Cohort 3-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 3-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
124880|NCT01860170|O2|Outcome|Cohort 2-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 2-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
124881|NCT01860170|O1|Outcome|Cohort 1-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 1-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
124907|NCT01859988|B2|Baseline|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
124908|NCT01859988|B1|Baseline|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
124882|NCT01860170|E3|Reported Event|Cohort 3-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 3-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
124883|NCT01860170|E2|Reported Event|Cohort 2-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 2-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
124884|NCT01860170|E1|Reported Event|Cohort 1-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 1-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
124885|NCT01860079|B3|Baseline|Total|Total of all reporting groups
124886|NCT01860079|B2|Baseline|Standard Discharge Group|Patients who stay longer (96-120 hours) as of a standard procedure
124887|NCT01860079|B1|Baseline|Early Discharge Group|"In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.~early discharge: In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours."
124888|NCT01860079|P2|Participant Flow|Standard Discharge Group|Patients who stay longer (96-120 hours) as of a standard procedure.
124889|NCT01860079|P1|Participant Flow|Early Discharge Group|In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.
124890|NCT01860079|O2|Outcome|Standard Discharge Group|Patients who stay longer (96-120 hours) as of a standard procedure
124891|NCT01860079|O1|Outcome|Early Discharge Group|"In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.~early discharge: In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours."
124892|NCT01860079|E2|Reported Event|Standard Discharge Group|Patients who stay longer (96-120 hours) as of a standard procedure. During the two year study period, 900 PPCI patients arrived at the three different study centers. After the exclusion of 131 patients due to primary exclusion criteria 769 patients were randomized in to two groups. There were 385 patients in the standard discharge group. Sixteen patients were excluded due to primary exclusion criteria such as signs of heart failure (n=7, %), clinically significant arrhythmia requiring treatment (n=3, %), chest pain recurrence (n=4,%), cardiogenic shock (n=1,%). Furthermore, a total of 6 patients were excluded for follow up reasons such as loosing contact with the patient or refusing to show up in the end of 1 month at the cardiology outpatient clinic. The study was terminated with 363 patients in the standard discharge group.
124893|NCT01860079|E1|Reported Event|Early Discharge Group|"In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.~early discharge: In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.~During 2 year study period, 900 PPCI patients arrived at the three different study centers. 769 patients were randomized in to two groups. There were 384 patients in the early discharge arm. Four patients were excluded due to social repatriation reasons. Furthermore, a total of 10 patients were excluded for follow up reasons such as loosing contact with the patient or refusing to show up in the end of 1 month at the cardiology outpatient clinic. The study was terminated with 370 patients in the early discharge group."
124894|NCT01860040|B3|Baseline|Total|Total of all reporting groups
124895|NCT01860040|B2|Baseline|Cisplatin and Gemcitabine|"Cisplatin on day 1 and gemcitabine on days 1 and 8, 1 cycle = 21 days, deliver 4 neoadjuvant cycles~Cisplatin~Gemcitabine"
124896|NCT01860040|B1|Baseline|Cisplatin and Pemetrexed|"Cisplatin on day 1 and pemetrexed on day 1, 1 cycle = 21 days, deliver 4 neoadjuvant cycles~Cisplatin~Pemetrexed"
124897|NCT01860040|P2|Participant Flow|Cisplatin and Gemcitabine|"Cisplatin on day 1 and gemcitabine on days 1 and 8, 1 cycle = 21 days, deliver 4 neoadjuvant cycles~Cisplatin~Gemcitabine"
124898|NCT01860040|P1|Participant Flow|Cisplatin and Pemetrexed|"Cisplatin on day 1 and pemetrexed on day 1, 1 cycle = 21 days, deliver 4 neoadjuvant cycles~Cisplatin~Pemetrexed"
124899|NCT01860040|O1|Outcome|Cisplatin and Pemetrexed|"Cisplatin on day 1 and pemetrexed on day 1, 1 cycle = 21 days, deliver 4 neoadjuvant cycles~Cisplatin~Pemetrexed"
124900|NCT01860040|E2|Reported Event|Cisplatin and Gemcitabine|"Cisplatin on day 1 and gemcitabine on days 1 and 8, 1 cycle = 21 days, deliver 4 neoadjuvant cycles~Cisplatin~Gemcitabine"
124901|NCT01860040|E1|Reported Event|Cisplatin and Pemetrexed|"Cisplatin on day 1 and pemetrexed on day 1, 1 cycle = 21 days, deliver 4 neoadjuvant cycles~Cisplatin~Pemetrexed"
124902|NCT01859988|B7|Baseline|Total|Total of all reporting groups
124903|NCT01859988|B6|Baseline|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
124904|NCT01859988|B5|Baseline|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124910|NCT01859988|P5|Participant Flow|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124911|NCT01859988|P4|Participant Flow|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab every 4 weeks (q4w) and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124912|NCT01859988|P3|Participant Flow|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
124913|NCT01859988|P2|Participant Flow|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab every 2 weeks (q2w) from Week 1 to Week 15.
124914|NCT01859988|P1|Participant Flow|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection every week (qw) from Week 1 to Week 15.
124915|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
124916|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124917|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124918|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
124919|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
124920|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
124921|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
124922|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124923|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124924|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
124925|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
124926|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
124927|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
124928|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124929|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124930|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
124931|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
124932|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
124933|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
124934|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124935|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124936|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
124937|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
124938|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
124939|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
124940|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124941|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124942|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
124943|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
124944|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
124945|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
124946|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124947|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124948|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
124949|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
124950|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
124951|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
124952|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124953|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124954|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
124955|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
124956|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
124957|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
124958|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124959|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124960|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
124961|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
124962|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
124963|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
124964|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124965|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124966|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
124967|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
124968|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
124969|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
124970|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124971|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124972|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
124973|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
124974|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
124975|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
124976|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124977|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124978|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
124979|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
124980|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
124981|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
124982|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124983|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124984|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
124985|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
124986|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
124987|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
124988|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124989|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124990|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
124991|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
125059|NCT01859637|O1|Outcome|Zarzio®/Filgrastim HEXAL®|All patients received open-label Zarzio®/Filgrastim HEXAL®
124992|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
124993|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
124994|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124995|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
124996|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
124997|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
124998|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
124999|NCT01859988|E6|Reported Event|Placebo|Participants who received 2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection every week (qw) from Week 1 to Week 15.
125000|NCT01859988|E5|Reported Event|Dupilumab 100 mg q4w|Participants who received 2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw when Dupilumab not administered from Week 1 to Week 15.
125001|NCT01859988|E4|Reported Event|Dupilumab 300 mg q4w|Participants who received 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw when Dupilumab not administered from Week 1 to Week 15.
125002|NCT01859988|E3|Reported Event|Dupilumab 200 mg q2w|Participants who received 2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
125003|NCT01859988|E2|Reported Event|Dupilumab 300 mg q2w|Participants who received 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
125004|NCT01859988|E1|Reported Event|Dupilumab 300 mg qw|Participants who received 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
125005|NCT01859949|B3|Baseline|Total|Total of all reporting groups
125006|NCT01859949|B2|Baseline|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
125007|NCT01859949|B1|Baseline|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
125008|NCT01859949|P2|Participant Flow|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
125009|NCT01859949|P1|Participant Flow|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
125010|NCT01859949|O2|Outcome|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
125011|NCT01859949|O1|Outcome|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
125012|NCT01859949|O2|Outcome|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
125013|NCT01859949|O1|Outcome|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
125014|NCT01859949|O2|Outcome|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
125015|NCT01859949|O1|Outcome|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
125016|NCT01859949|O2|Outcome|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
125017|NCT01859949|O1|Outcome|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
125018|NCT01859949|O2|Outcome|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
125019|NCT01859949|O1|Outcome|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
125020|NCT01859949|O2|Outcome|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
125021|NCT01859949|O1|Outcome|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
125022|NCT01859949|E2|Reported Event|Dose-Remainig Group|Participants in the 0.067 mg/kg/day group in previous study were maintained on the dose in this expention study
125023|NCT01859949|E1|Reported Event|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
125024|NCT01859793|B3|Baseline|Total|Total of all reporting groups
125025|NCT01859793|B2|Baseline|Sitagliptin 1st|"100mg pill, PO administered once daily.~sitagliptin: 100 mg pill, administered once/day orally"
144016|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
125026|NCT01859793|B1|Baseline|Matching Placebo 1st|"Matching Placebo for Sitagliptin~Placebo: Matching placebo in appearance given once/day orally"
125027|NCT01859793|P2|Participant Flow|Sitagliptin First Then Placebo|sitagliptin: 100 mg pill, administered once/day orally for 8 weeks followed by matching placebo for 8 weeks following a 4 week washout period.
125028|NCT01859793|P1|Participant Flow|Placebo 1st Then Sitagliptin|"Matching Placebo for Sitagliptin~Placebo: Matching placebo in appearance given once/day orally for 8 weeks followed by 8 weeks of 100 mg sitaglipin/day separated by a 4 week washout period"
125029|NCT01859793|O2|Outcome|Sitagliptin|"100mg pill, PO administered once daily.~sitagliptin: 100 mg pill, administered once/day orally"
125030|NCT01859793|O1|Outcome|Matching Placebo|"Matching Placebo for Sitagliptin~Placebo: Matching placebo in appearance given once/day orally"
125031|NCT01859793|O2|Outcome|Sitagliptin|"100mg pill, PO administered once daily.~sitagliptin: 100 mg pill, administered once/day orally"
125032|NCT01859793|O1|Outcome|Matching Placebo|"Matching Placebo for Sitagliptin~Placebo: Matching placebo in appearance given once/day orally"
125033|NCT01859793|O2|Outcome|Sitagliptin|"100mg pill, PO administered once daily.~sitagliptin: 100 mg pill, administered once/day orally"
125034|NCT01859793|O1|Outcome|Matching Placebo|"Matching Placebo for Sitagliptin~Placebo: Matching placebo in appearance given once/day orally"
125035|NCT01859793|E2|Reported Event|Sitagliptin|"100mg pill, PO administered once daily.~sitagliptin: 100 mg pill, administered once/day orally"
125036|NCT01859793|E1|Reported Event|Matching Placebo|"Matching Placebo for Sitagliptin~Placebo: Matching placebo in appearance given once/day orally"
125037|NCT01859715|B4|Baseline|Total|Total of all reporting groups
125038|NCT01859715|B3|Baseline|Nausea-observational Group|Patients given ondansetron for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only.
125039|NCT01859715|B2|Baseline|Hydrocodone/Acetaminophen Group|Subjects given hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.
125040|NCT01859715|B1|Baseline|Oxycodone Group|Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization.
125041|NCT01859715|P3|Participant Flow|Nausea-observational Group|Patients given ondansetron 4mg for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only.
125042|NCT01859715|P2|Participant Flow|Hydrocodone/Acetaminophen Group|Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
125043|NCT01859715|P1|Participant Flow|Oxycodone Group|Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization.
125044|NCT01859715|O3|Outcome|Nausea-observational Group|Patients given ondansetron 4mg for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only.
125045|NCT01859715|O2|Outcome|Hydrocodone/Acetaminophen Group|Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
125046|NCT01859715|O1|Outcome|Oxycodone Group|Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization.
125047|NCT01859715|O3|Outcome|Nausea-observational Group|Patients given ondansetron 4mg for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only.
125048|NCT01859715|O2|Outcome|Hydrocodone/Acetaminophen Group|Subjects given or hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
125049|NCT01859715|O1|Outcome|Oxycodone Group|Subjects given oxycodone 5mg mg by ED provider decision or by triage nurse randomization.
125050|NCT01859715|E3|Reported Event|Nausea-observational Group|"Patients given ondansetron by ED provider decision or by triage nurse. This is an observational cohort only.~Oxycodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.~Hydrocodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.~Ondansetron: Subjects given ondansetron for reported nausea or vomiting. Treatment determined either by triage nursing protocol or by provider discretion. Observational intervention only."
125051|NCT01859715|E2|Reported Event|Hydrocodone/Acetaminophen Group|"Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.~Oxycodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.~Hydrocodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization."
125052|NCT01859715|E1|Reported Event|Oxycodone Group|"Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.~Oxycodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.~Hydrocodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization."
125053|NCT01859702|B1|Baseline|VIGADEXA|Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
125054|NCT01859702|P1|Participant Flow|VIGADEXA|Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
125055|NCT01859702|O1|Outcome|VIGADEXA|Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
125056|NCT01859702|E1|Reported Event|VIGADEXA|Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
125057|NCT01859637|B1|Baseline|Zarzio®/Filgrastim HEXAL®|Open label single arm. All patients received Zarzio®/Filgrastim HEXAL® subcutaneously dosed as per recommendations in SmPC.
125058|NCT01859637|P1|Participant Flow|Zarzio®/Filgrastim HEXAL® (EP2006)|Open label single arm. All patients received Zarzio® subcutaneously dosed as per recommendations in Summary of Product Characteristics (SmPC).
125061|NCT01859637|O1|Outcome|Zarzio®/Filgrastim HEXAL®|All patients received open-label Zarzio®/Filgrastim HEXAL®
125062|NCT01859637|E1|Reported Event|Open-label Zarzio®/Filgrastim HEXAL®|All patients received open-label Zarzio®/Filgrastim HEXAL®
125063|NCT01859611|B1|Baseline|Radiofrequency|"Radiofrequency (RF) treatment with the TriActive+ RF device on the peri-oral and/or peri-orbital areas of the face once a week for eight weeks.~TriActive+ RF: Radio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special skin contact identification system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts."
125064|NCT01859611|P1|Participant Flow|Radiofrequency|"Radiofrequency (RF) treatment with the TriActive+ RF device on the peri-oral and/or peri-orbital areas of the face once a week for eight weeks.~TriActive+ RF: Radio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special skin contact identification system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts."
125065|NCT01859611|O1|Outcome|Radiofrequency|"Radiofrequency (RF) treatment with the TriActive+ RF device on the peri-oral and/or peri-orbital areas of the face once a week for eight weeks.~TriActive+ RF: Radio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special skin contact identification system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts."
125066|NCT01859611|E1|Reported Event|Radiofrequency|"Radiofrequency (RF) treatment with the TriActive+ RF device on the peri-oral and/or peri-orbital areas of the face once a week for eight weeks.~TriActive+ RF: Radio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special skin contact identification system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts."
125067|NCT01859598|B1|Baseline|Follow up for 6 Months|"At the baseline stage:~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);"
125068|NCT01859598|P1|Participant Flow|6-month Follow-up for Basal Insulin Treatment Study (ORBIT)|"At the baseline stage:~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);"
125069|NCT01859598|O1|Outcome|Follow up for 6 Months|"At the baseline stage:~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);~At visit 1: Patients remained at baseline, N=18995; Loss to follow-up, N=1742 At visit 2, N=17253; Come back at visit 3, N=605 Loss to follow-up, N=1517 At visit 3, N=16341, among them, 10416 patients had FPG information"
125070|NCT01859598|O1|Outcome|Follow up for 6 Months|"At the baseline stage:~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);~At visit 1: Patients remained at baseline, N=18995; Loss to follow-up, N=1742 At visit 2, N=17253; Come back at visit 3, N=605 Loss to follow-up, N=1517 At visit 3, N=16341, among them, 10416 patients had FPG information"
125071|NCT01859598|O1|Outcome|Follow up for 6 Months|"At the baseline stage:~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);~At visit 1: Patients remained at baseline, N=18995; Loss to follow-up, N=1742 At visit 2, N=17253; Come back at visit 3, N=605 Loss to follow-up, N=1517 At visit 3, N=16341"
125072|NCT01859598|O1|Outcome|Follow up for 6 Months|"At the baseline stage:~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);~At visit 1: Patients remained at baseline, N=18995; Loss to follow-up, N=1742 At visit 2, N=17253; Come back at visit 3, N=605 Loss to follow-up, N=1517 At visit 3, N=16341"
125073|NCT01859598|O1|Outcome|Basal Insulin Treatment Study (ORBIT)|
125074|NCT01859598|E1|Reported Event|Follow up for 6 Months|"At the baseline stage:~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);~At visit 1: Patients remained at baseline, N=18995; Loss to follow-up, N=1742 At visit 2, N=17253; Come back at visit 3, N=605 Loss to follow-up, N=1517 At visit 3, N=16341"
125075|NCT01859507|B1|Baseline|Botox|"Injection of Clostridium Botulinum type A neurotoxin complex in the perineal muscles in resistant cases of vaginismus.~Trade Name:~BOTOX 100 units vial~Injection of Botox in the perineal muscles in resistant cases of vaginismus"
125076|NCT01859507|P1|Participant Flow|Botox|"Injection of Clostridium Botulinum type A neurotoxin complex in the perineal muscles in resistant cases of vaginismus.~Trade Name:~BOTOX 100 units vial~Injection of Botox in the perineal muscles in resistant cases of vaginismus"
125077|NCT01859507|O1|Outcome|BOTOX Group|"Injection of BOTOX 100 units vial as a single dose intramuscular in the perineal muscles. Proper informed consent forms will be signed. In most of the cases we use local anesthetic before injection. However in V4 and 5 we resort to general anesthesia. We followed up the patient by phone calls daily for possible adverse effects following the procedure for 4 days, which is the interval allowed for the BOTOX to be fully effective. The patient is then instructed to attend dilatation sessions twice weekly in the clinic, in the presence of the husband, for 3-4 weeks. We use silicone dilators covered by lubricated condoms. We start each session with the appropriate size of the dilator according to the capacity of the introitus and increase the size gradually thereafter. We proceed till the patient uses the largest dilator with no or limited pain. The patient is then advised then to try to have intercourse and report back to us.~Botox: In the first session, proper histor"
125078|NCT01859507|O1|Outcome|Botox|"Injection of Clostridium Botulinum type A neurotoxin complex in the perineal muscles in resistant cases of vaginismus.~Trade Name:~BOTOX 100 units vial~Injection of Botox in the perineal muscles in resistant cases of vaginismus"
125079|NCT01859507|E1|Reported Event|Botox|"Injection of Clostridium Botulinum type A neurotoxin complex in the perineal muscles in resistant cases of vaginismus.~Trade Name:~BOTOX 100 units vial~Injection of Botox in the perineal muscles in resistant cases of vaginismus"
125080|NCT01859494|B1|Baseline|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
125661|NCT01856907|O2|Outcome|Placebo Pill|"1 pill/BID for 16 weeks~Placebo pill: Will evaluate effect of lifestyle and diet only"
125081|NCT01859494|P1|Participant Flow|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
125082|NCT01859494|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
125083|NCT01859494|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
125084|NCT01859494|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
125085|NCT01859494|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
125086|NCT01859494|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
125087|NCT01859494|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
125088|NCT01859494|E1|Reported Event|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
125089|NCT01859390|B3|Baseline|Total|Total of all reporting groups
125090|NCT01859390|B2|Baseline|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
125091|NCT01859390|B1|Baseline|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
125092|NCT01859390|P2|Participant Flow|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
125093|NCT01859390|P1|Participant Flow|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
125094|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
125095|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
125096|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
125097|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
125098|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
125099|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
125100|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
125101|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
125102|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
125103|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
125104|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
125205|NCT01859247|E8|Reported Event|Subject 8|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Supplemental Motor Area Primary Motor Cortex Sham Dorsal Premotor Cortex"
126434|NCT01854658|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
125105|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
125106|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
125107|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
125108|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
125109|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
125110|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
125111|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
125112|NCT01859390|E2|Reported Event|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
125113|NCT01859390|E1|Reported Event|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
125114|NCT01859325|B3|Baseline|Total|Total of all reporting groups
125115|NCT01859325|B2|Baseline|Placebo|Placebo for the IL-12 pDNA adjuvant and HIV-MAG pDNA vaccine (sodium chloride for injection, USP 0.9%) will be administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid at weeks 0, 4, 12, and 36 with EP using the TDS device. Placebo for the rVSV HIV gag (sodium chloride for injection, USP 0.9%) will be administered as 1 mL IM injection in the left deltoid and 1 mL IM injection in the right deltoid at week 24 and 48.
125206|NCT01859247|E7|Reported Event|Subject 7|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Sham Primary Motor Cortex Dorsal Premotor Cortex Anterior Cingulate Cortex Supplemental Motor Area"
125116|NCT01859325|B1|Baseline|HIV-Mag/IL-12 & rVSV Vaccine|HIV-MAG pDNA vaccine prime will be administered at a dose of 3000 g (1500 g of the HIV-1 gag/pol plasmid and 1500 g of the HIV-1 net/tat/vif, env plasmid) at week 0, 4, 12, and 36. Each construct of HIV-MAG pDNA vaccine (1500 g each) will be mixed and combined with 1000 g of the IL-12 pDNA adjuvant. The resulting mixture will be divided into 2 IM injections and administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid with EP using the TDS device. IL-12 pDNA adjuvant will be mixed with the HIV-MAG pDNA vaccine prime, as noted above, and administered at a dose of 1000 g (500 g in each IM injection) at week 0, 4, 12, and 36. rVSV HIV gag booster vaccine--The total dose, 1x107 pfu, will be administered as 1 mL (5x106 pfu) IM injection in the left deltoid and 1 mL (5x106 pfu) IM injection in the right deltoid at week 24 and 48.
125117|NCT01859325|P3|Participant Flow|Excluded|Participants not meeting inclusion criteria or declined to participate.
125118|NCT01859325|P2|Participant Flow|Placebo|Placebo for the IL-12 pDNA adjuvant and HIV-MAG pDNA vaccine (sodium chloride for injection, USP 0.9%) will be administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid at weeks 0, 4, 12, and 36 with EP using the TDS device. Placebo for the rVSV HIV gag (sodium chloride for injection, USP 0.9%) will be administered as 1 mL IM injection in the left deltoid and 1 mL IM injection in the right deltoid at week 24 and 48.
125119|NCT01859325|P1|Participant Flow|HIV-Mag/IL-12 & rVSV Vaccine|HIV-MAG pDNA vaccine prime will be administered at a dose of 3000 g (1500 g of the HIV-1 gag/pol plasmid and 1500 g of the HIV-1 net/tat/vif, env plasmid) at week 0, 4, 12, and 36. Each construct of HIV-MAG pDNA vaccine (1500 g each) will be mixed and combined with 1000 g of the IL-12 pDNA adjuvant. The resulting mixture will be divided into 2 IM injections and administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid with EP using the TDS device. IL-12 pDNA adjuvant will be mixed with the HIV-MAG pDNA vaccine prime, as noted above, and administered at a dose of 1000 g (500 g in each IM injection) at week 0, 4, 12, and 36. rVSV HIV gag booster vaccine--The total dose, 1x107 pfu, will be administered as 1 mL (5x106 pfu) IM injection in the left deltoid and 1 mL (5x106 pfu) IM injection in the right deltoid at week 24 and 48.
125120|NCT01859325|O2|Outcome|Placebo|Placebo for the IL-12 pDNA adjuvant and HIV-MAG pDNA vaccine (sodium chloride for injection, USP 0.9%) will be administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid at weeks 0, 4, 12, and 36 with EP using the TDS device. Placebo for the rVSV HIV gag (sodium chloride for injection, USP 0.9%) will be administered as 1 mL IM injection in the left deltoid and 1 mL IM injection in the right deltoid at week 24 and 48.
125121|NCT01859325|O1|Outcome|HIV-Mag/IL-12 & rVSV Vaccine|HIV-MAG pDNA vaccine prime will be administered at a dose of 3000 g (1500 g of the HIV-1 gag/pol plasmid and 1500 g of the HIV-1 net/tat/vif, env plasmid) at week 0, 4, 12, and 36. Each construct of HIV-MAG pDNA vaccine (1500 g each) will be mixed and combined with 1000 g of the IL-12 pDNA adjuvant. The resulting mixture will be divided into 2 IM injections and administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid with EP using the TDS device. IL-12 pDNA adjuvant will be mixed with the HIV-MAG pDNA vaccine prime, as noted above, and administered at a dose of 1000 g (500 g in each IM injection) at week 0, 4, 12, and 36. rVSV HIV gag booster vaccine--The total dose, 1x107 pfu, will be administered as 1 mL (5x106 pfu) IM injection in the left deltoid and 1 mL (5x106 pfu) IM injection in the right deltoid at week 24 and 48.
125122|NCT01859325|O2|Outcome|Placebo|Placebo for the IL-12 pDNA adjuvant and HIV-MAG pDNA vaccine (sodium chloride for injection, USP 0.9%) will be administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid at weeks 0, 4, 12, and 36 with EP using the TDS device. Placebo for the rVSV HIV gag (sodium chloride for injection, USP 0.9%) will be administered as 1 mL IM injection in the left deltoid and 1 mL IM injection in the right deltoid at week 24 and 48.
125123|NCT01859325|O1|Outcome|HIV-Mag/IL-12 & rVSV Vaccine|HIV-MAG pDNA vaccine prime will be administered at a dose of 3000 g (1500 g of the HIV-1 gag/pol plasmid and 1500 g of the HIV-1 net/tat/vif, env plasmid) at week 0, 4, 12, and 36. Each construct of HIV-MAG pDNA vaccine (1500 g each) will be mixed and combined with 1000 g of the IL-12 pDNA adjuvant. The resulting mixture will be divided into 2 IM injections and administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid with EP using the TDS device. IL-12 pDNA adjuvant will be mixed with the HIV-MAG pDNA vaccine prime, as noted above, and administered at a dose of 1000 g (500 g in each IM injection) at week 0, 4, 12, and 36. rVSV HIV gag booster vaccine--The total dose, 1x107 pfu, will be administered as 1 mL (5x106 pfu) IM injection in the left deltoid and 1 mL (5x106 pfu) IM injection in the right deltoid at week 24 and 48.
125124|NCT01859325|E2|Reported Event|Placebo|Placebo for the IL-12 pDNA adjuvant and HIV-MAG pDNA vaccine (sodium chloride for injection, USP 0.9%) will be administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid at weeks 0, 4, 12, and 36 with EP using the TDS device. Placebo for the rVSV HIV gag (sodium chloride for injection, USP 0.9%) will be administered as 1 mL IM injection in the left deltoid and 1 mL IM injection in the right deltoid at week 24 and 48.
125125|NCT01859325|E1|Reported Event|HIV-Mag/IL-12 & rVSV Vaccine|HIV-MAG pDNA vaccine prime will be administered at a dose of 3000 g (1500 g of the HIV-1 gag/pol plasmid and 1500 g of the HIV-1 net/tat/vif, env plasmid) at week 0, 4, 12, and 36. Each construct of HIV-MAG pDNA vaccine (1500 g each) will be mixed and combined with 1000 g of the IL-12 pDNA adjuvant. The resulting mixture will be divided into 2 IM injections and administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid with EP using the TDS device. IL-12 pDNA adjuvant will be mixed with the HIV-MAG pDNA vaccine prime, as noted above, and administered at a dose of 1000 g (500 g in each IM injection) at week 0, 4, 12, and 36. rVSV HIV gag booster vaccine--The total dose, 1x107 pfu, will be administered as 1 mL (5x106 pfu) IM injection in the left deltoid and 1 mL (5x106 pfu) IM injection in the right deltoid at week 24 and 48.
125126|NCT01859312|B1|Baseline|Continuous Sub-Q Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125207|NCT01859247|E6|Reported Event|Subject 6|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex"
126435|NCT01854658|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
125127|NCT01859312|P1|Participant Flow|Continuous Sub-Q Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) received continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to achieve near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125128|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125129|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125130|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125131|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125132|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125133|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125134|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125135|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125136|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125137|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125138|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125139|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125140|NCT01859312|O1|Outcome|Continuous Subcutaenous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125141|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125142|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125143|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125144|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125145|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125146|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125147|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125148|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125149|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125150|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125151|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125152|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125153|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125154|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125155|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125156|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125157|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125158|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125159|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125160|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125161|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125162|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125163|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125164|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125165|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125166|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125167|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125168|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125169|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125170|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125171|NCT01859312|O1|Outcome|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125172|NCT01859312|E1|Reported Event|Continuous Subcutaneous Hydrocortisone Infusion|"Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy~Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)~Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)"
125173|NCT01859247|B9|Baseline|Total|Total of all reporting groups
125174|NCT01859247|B8|Baseline|Subject 8|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Supplemental Motor Area Primary Motor Cortex Sham Dorsal Premotor Cortex"
125175|NCT01859247|B7|Baseline|Subject 7|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Sham Primary Motor Cortex Dorsal Premotor Cortex Anterior Cingulate Cortex Supplemental Motor Area"
125176|NCT01859247|B6|Baseline|Subject 6|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex"
125177|NCT01859247|B5|Baseline|Subject 5|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Sham Dorsal Premotor Cortex Primary Motor Cortex Supplemental Motor Area Anterior Cingulate Cortex"
125178|NCT01859247|B4|Baseline|Subject 4|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Supplemental Motor Area Sham Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex"
125179|NCT01859247|B3|Baseline|Subject 3|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex Anterior Cingulate Cortex"
125180|NCT01859247|B2|Baseline|Subject 2|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex Sham Supplemental Motor Area"
125181|NCT01859247|B1|Baseline|Subject 1|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Primary Motor Cortex Supplemental Motor Area Sham Dorsal Premotor Cortex Anterior Cingulate Cortex"
125182|NCT01859247|P8|Participant Flow|Subject 8|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Supplemental Motor Area Primary Motor Cortex Sham Dorsal Premotor Cortex"
125183|NCT01859247|P7|Participant Flow|Subject 7|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Sham Primary Motor Cortex Dorsal Premotor Cortex Anterior Cingulate Cortex Supplemental Motor Area"
125184|NCT01859247|P6|Participant Flow|Subject 6|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex"
125185|NCT01859247|P5|Participant Flow|Subject 5|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Sham Dorsal Premotor Cortex Primary Motor Cortex Supplemental Motor Area Anterior Cingulate Cortex"
125186|NCT01859247|P4|Participant Flow|Subject 4|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Supplemental Motor Area Sham Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex"
125187|NCT01859247|P3|Participant Flow|Subject 3|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex Anterior Cingulate Cortex"
125188|NCT01859247|P2|Participant Flow|Subject 2|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex Sham Supplemental Motor Area"
125189|NCT01859247|P1|Participant Flow|Subject 1|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Primary Motor Cortex Supplemental Motor Area Sham Dorsal Premotor Cortex Anterior Cingulate Cortex"
125190|NCT01859247|O5|Outcome|Sham rTMS|0.2Hz for 15 minutes:
125191|NCT01859247|O4|Outcome|Supplemental Motor Area rTMS|0.2Hz for 15 minutes:
125192|NCT01859247|O3|Outcome|Dorsal Premotor rTMS|0.2Hz for 15 minutes:
125193|NCT01859247|O2|Outcome|Anterior Cingulate rTMS|0.2Hz for 15 minutes:
125194|NCT01859247|O1|Outcome|Primary Motor Cortex rTMS|0.2Hz for 15 minutes
125195|NCT01859247|O5|Outcome|Sham rTMS|0.2Hz for 15 minutes
125196|NCT01859247|O4|Outcome|Supplemental Motor Area rTMS|0.2Hz for 15 minutes
125197|NCT01859247|O3|Outcome|Dorsal Premotor rTMS|0.2Hz for 15 minutes
125198|NCT01859247|O2|Outcome|Anterior Cingulate rTMS|0.2Hz for 15 minutes
125199|NCT01859247|O1|Outcome|Primary Motor Cortex rTMS|0.2Hz for 15 minutes
125200|NCT01859247|O5|Outcome|Sham rTMS|0.2Hz for 15 minutes:
125201|NCT01859247|O4|Outcome|Supplemental Motor Area rTMS|0.2Hz for 15 minutes:
125202|NCT01859247|O3|Outcome|Dorsal Premotor rTMS|0.2Hz for 15 minutes:
125203|NCT01859247|O2|Outcome|Anterior Cingulate rTMS|0.2Hz for 15 minutes:
125204|NCT01859247|O1|Outcome|Primary Motor Cortex rTMS|0.2Hz for 15 minutes
125467|NCT01857882|B3|Baseline|Total|Total of all reporting groups
125208|NCT01859247|E5|Reported Event|Subject 5|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Sham Dorsal Premotor Cortex Primary Motor Cortex Supplemental Motor Area Anterior Cingulate Cortex"
125209|NCT01859247|E4|Reported Event|Subject 4|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Supplemental Motor Area Sham Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex"
125210|NCT01859247|E3|Reported Event|Subject 3|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex Anterior Cingulate Cortex"
125211|NCT01859247|E2|Reported Event|Subject 2|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex Sham Supplemental Motor Area"
125212|NCT01859247|E1|Reported Event|Subject 1|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Primary Motor Cortex Supplemental Motor Area Sham Dorsal Premotor Cortex Anterior Cingulate Cortex"
125213|NCT01859195|B3|Baseline|Total|Total of all reporting groups
125214|NCT01859195|B2|Baseline|Cognitive Interviews|
125215|NCT01859195|B1|Baseline|Focus Groups|
125216|NCT01859195|P2|Participant Flow|Cognitive Interview Stage|~12-16 participants in individual cognitive interviews
125217|NCT01859195|P1|Participant Flow|Focus Group Stage|~20-24 participants, to comprise 3-6 focus groups
125218|NCT01859195|O2|Outcome|Number of Participants: Cognitive Interviews|number of participants who completed cognitive interview stage
125219|NCT01859195|O1|Outcome|Number of Participants: Focus Groups|number of participants who completed focus group stage
125220|NCT01859195|O2|Outcome|Number of Participants: Cognitive Interviews|Number of participants in cognitive interview stage
125221|NCT01859195|O1|Outcome|Number of Participants: Focus Group|Number of participants in focus group stage
125222|NCT01859195|E2|Reported Event|Cognitive Interviews|
125223|NCT01859195|E1|Reported Event|Focus Groups|
125224|NCT01859143|B3|Baseline|Total|Total of all reporting groups
125225|NCT01859143|B2|Baseline|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
125226|NCT01859143|B1|Baseline|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.
125227|NCT01859143|P2|Participant Flow|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
125228|NCT01859143|P1|Participant Flow|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.
125229|NCT01859143|O2|Outcome|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
125230|NCT01859143|O1|Outcome|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) FFU of trivalent influenza vaccine administered as intranasal spray on Day 1.
125231|NCT01859143|O2|Outcome|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
125232|NCT01859143|O1|Outcome|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) FFU of trivalent influenza vaccine administered as intranasal spray on Day 1.
125233|NCT01859143|O2|Outcome|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
125234|NCT01859143|O1|Outcome|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) FFU of trivalent influenza vaccine administered as intranasal spray on Day 1.
125235|NCT01859143|O2|Outcome|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
125236|NCT01859143|O1|Outcome|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) FFU of trivalent influenza vaccine administered as intranasal spray on Day 1.
125237|NCT01859143|O2|Outcome|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
125238|NCT01859143|O1|Outcome|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.
125239|NCT01859143|E2|Reported Event|PLACEBO|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
125240|NCT01859143|E1|Reported Event|TRIVALENT VACCINE|A single dose of 10^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.
125241|NCT01859078|B1|Baseline|Baricitinib + Digoxin|"Digoxin - 0.5 mg administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 16.~Baricitinib - 10 mg administered orally, QD, immediately prior to digoxin on Days 8 through 16."
125242|NCT01859078|P1|Participant Flow|Baricitinib + Digoxin|"Digoxin - 0.5 milligrams (mg) administered orally, twice daily (BID), 12 hours apart on Day 1. Then, 0.25 mg administered orally, once daily (QD) on Days 2 through 16.~Baricitinib - 10 mg administered orally, QD, immediately prior to digoxin on Days 8 through 16."
125243|NCT01859078|O2|Outcome|Baricitinib + Digoxin|10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
125244|NCT01859078|O1|Outcome|Digoxin Only|0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7.
125245|NCT01859078|O2|Outcome|Baricitinib + Digoxin|10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
125246|NCT01859078|O1|Outcome|Digoxin Only|0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7.
125247|NCT01859078|O2|Outcome|Baricitinib + Digoxin|10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
125248|NCT01859078|O1|Outcome|Digoxin Only|0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7.
125249|NCT01859078|O2|Outcome|Baricitinib + Digoxin|10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
125250|NCT01859078|O1|Outcome|Digoxin Only|0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7.
144017|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
125251|NCT01859078|O2|Outcome|Baricitinib + Digoxin|10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
125252|NCT01859078|O1|Outcome|Digoxin Only|0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7.
125253|NCT01859078|E2|Reported Event|Baricitinib + Digoxin|10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
125254|NCT01859078|E1|Reported Event|Digoxin Only|0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7.
125255|NCT01859013|B3|Baseline|Total|Total of all reporting groups
125256|NCT01859013|B2|Baseline|Sugar Pill|"Four (4) weeks of meal replacement therapy, followed by 28-weeks of placebo (sugar pill) therapy.~Placebo: Placebo will be taken orally once daily in the evening for the first two weeks, and orally twice daily (AM and PM) for the remainder of the study."
125257|NCT01859013|B1|Baseline|Topiramate|"Four (4) weeks of meal replacement therapy, followed by 28-weeks of topiramate therapy. Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks.~Topiramate: Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks. Patients who do not tolerate dose escalation will be reduced to the highest tolerated dose for the remainder of the trial."
125258|NCT01859013|P2|Participant Flow|Sugar Pill|"Four (4) weeks of meal replacement therapy, followed by 28-weeks of placebo (sugar pill) therapy.~Placebo: Placebo will be taken orally once daily in the evening for the first two weeks, and orally twice daily (AM and PM) for the remainder of the study."
125259|NCT01859013|P1|Participant Flow|Topiramate|"Four (4) weeks of meal replacement therapy, followed by 28-weeks of topiramate therapy. Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks.~Topiramate: Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks. Patients who do not tolerate dose escalation will be reduced to the highest tolerated dose for the remainder of the trial."
125260|NCT01859013|O2|Outcome|Sugar Pill|"Four (4) weeks of meal replacement therapy, followed by 28-weeks of placebo (sugar pill) therapy.~Placebo: Placebo will be taken orally once daily in the evening for the first two weeks, and orally twice daily (AM and PM) for the remainder of the study."
125261|NCT01859013|O1|Outcome|Topiramate|"Four (4) weeks of meal replacement therapy, followed by 28-weeks of topiramate therapy. Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks.~Topiramate: Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks. Patients who do not tolerate dose escalation will be reduced to the highest tolerated dose for the remainder of the trial."
125262|NCT01859013|E2|Reported Event|Sugar Pill|"Four (4) weeks of meal replacement therapy, followed by 28-weeks of placebo (sugar pill) therapy.~Placebo: Placebo will be taken orally once daily in the evening for the first two weeks, and orally twice daily (AM and PM) for the remainder of the study."
125263|NCT01859013|E1|Reported Event|Topiramate|"Four (4) weeks of meal replacement therapy, followed by 28-weeks of topiramate therapy. Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks.~Topiramate: Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks. Patients who do not tolerate dose escalation will be reduced to the highest tolerated dose for the remainder of the trial."
125264|NCT01858766|B20|Baseline|Total|Total of all reporting groups
125265|NCT01858766|B19|Baseline|SOF+VEL 100 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
125266|NCT01858766|B18|Baseline|SOF+VEL 100 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
125267|NCT01858766|B17|Baseline|SOF+VEL 25 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
125268|NCT01858766|B16|Baseline|SOF+VEL 25 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
125269|NCT01858766|B15|Baseline|SOF+VEL 100 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
125270|NCT01858766|B14|Baseline|SOF+VEL 100 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
125271|NCT01858766|B13|Baseline|SOF+VEL 25 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
125272|NCT01858766|B12|Baseline|SOF+VEL 25 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
125273|NCT01858766|B11|Baseline|SOF+VEL 100 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
125274|NCT01858766|B10|Baseline|SOF+VEL 25 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
125275|NCT01858766|B9|Baseline|SOF+VEL 25 mg 12 Weeks (GT5)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
125276|NCT01858766|B8|Baseline|SOF+VEL 100 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
125277|NCT01858766|B7|Baseline|SOF+VEL 25 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
125278|NCT01858766|B6|Baseline|SOF+VEL 100 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
125279|NCT01858766|B5|Baseline|SOF+VEL 25 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
125280|NCT01858766|B4|Baseline|SOF+VEL 100 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
125281|NCT01858766|B3|Baseline|SOF+VEL 25 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
125282|NCT01858766|B2|Baseline|SOF+VEL 100 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
125283|NCT01858766|B1|Baseline|SOF+VEL 25 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
125284|NCT01858766|P19|Participant Flow|SOF+VEL 100 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
125285|NCT01858766|P18|Participant Flow|SOF+VEL 100 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
125286|NCT01858766|P17|Participant Flow|SOF+VEL 25 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
125287|NCT01858766|P16|Participant Flow|SOF+VEL 25 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
125288|NCT01858766|P15|Participant Flow|SOF+VEL 100 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
125289|NCT01858766|P14|Participant Flow|SOF+VEL 100 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
125290|NCT01858766|P13|Participant Flow|SOF+VEL 25 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
125291|NCT01858766|P12|Participant Flow|SOF+VEL 25 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
125292|NCT01858766|P11|Participant Flow|SOF+VEL 100 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
125293|NCT01858766|P10|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
125294|NCT01858766|P9|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT5)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
125295|NCT01858766|P8|Participant Flow|SOF+VEL 100 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
125296|NCT01858766|P7|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
125297|NCT01858766|P6|Participant Flow|SOF+VEL 100 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
125298|NCT01858766|P5|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
125299|NCT01858766|P4|Participant Flow|SOF+VEL 100 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
125300|NCT01858766|P3|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
125301|NCT01858766|P2|Participant Flow|SOF+VEL 100 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
125302|NCT01858766|P1|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT1)|Sofosbuvir (SOF) 400 mg tablet + velpatasvir (VEL) 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 1)
125303|NCT01858766|O19|Outcome|SOF+VEL 100 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
125304|NCT01858766|O18|Outcome|SOF+VEL 100 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
125305|NCT01858766|O17|Outcome|SOF+VEL 25 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
125306|NCT01858766|O16|Outcome|SOF+VEL 25 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
125307|NCT01858766|O15|Outcome|SOF+VEL 100 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
125308|NCT01858766|O14|Outcome|SOF+VEL 100 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
125309|NCT01858766|O13|Outcome|SOF+VEL 25 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
125310|NCT01858766|O12|Outcome|SOF+VEL 25 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
125311|NCT01858766|O11|Outcome|SOF+VEL 100 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
125312|NCT01858766|O10|Outcome|SOF+VEL 25 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
125313|NCT01858766|O9|Outcome|SOF+VEL 25 mg 12 Weeks (GT5)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
125314|NCT01858766|O8|Outcome|SOF+VEL 100 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
125315|NCT01858766|O7|Outcome|SOF+VEL 25 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
125316|NCT01858766|O6|Outcome|SOF+VEL 100 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
125317|NCT01858766|O5|Outcome|SOF+VEL 25 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
125318|NCT01858766|O4|Outcome|SOF+VEL 100 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
125319|NCT01858766|O3|Outcome|SOF+VEL 25 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
125320|NCT01858766|O2|Outcome|SOF+VEL 100 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
125321|NCT01858766|O1|Outcome|SOF+VEL 25 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
125322|NCT01858766|O19|Outcome|SOF+VEL 100 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
125323|NCT01858766|O18|Outcome|SOF+VEL 100 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
125324|NCT01858766|O17|Outcome|SOF+VEL 25 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
125325|NCT01858766|O16|Outcome|SOF+VEL 25 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
125326|NCT01858766|O15|Outcome|SOF+VEL 100 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
125327|NCT01858766|O14|Outcome|SOF+VEL 100 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
125328|NCT01858766|O13|Outcome|SOF+VEL 25 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
125329|NCT01858766|O12|Outcome|SOF+VEL 25 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
125330|NCT01858766|O11|Outcome|SOF+VEL 100 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
125331|NCT01858766|O10|Outcome|SOF+VEL 25 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
125332|NCT01858766|O9|Outcome|SOF+VEL 25 mg 12 Weeks (GT5)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
125333|NCT01858766|O8|Outcome|SOF+VEL 100 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
125334|NCT01858766|O7|Outcome|SOF+VEL 25 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
125335|NCT01858766|O6|Outcome|SOF+VEL 100 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
125336|NCT01858766|O5|Outcome|SOF+VEL 25 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
125337|NCT01858766|O4|Outcome|SOF+VEL 100 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
125338|NCT01858766|O3|Outcome|SOF+VEL 25 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
125339|NCT01858766|O2|Outcome|SOF+VEL 100 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
125340|NCT01858766|O1|Outcome|SOF+VEL 25 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
125341|NCT01858766|O6|Outcome|SOF+VEL 100 mg + RBV 8 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
125342|NCT01858766|O5|Outcome|SOF+VEL 100 mg 8 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (all genotypes)
125343|NCT01858766|O4|Outcome|SOF+VEL 25 mg + RBV 8 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
125344|NCT01858766|O3|Outcome|SOF+VEL 25 mg 8 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (all genotypes)
125345|NCT01858766|O2|Outcome|SOF+VEL 100 mg 12 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (all genotypes)
125346|NCT01858766|O1|Outcome|SOF+VEL 25 mg 12 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (all genotypes)
125347|NCT01858766|O19|Outcome|SOF+VEL 100 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
125348|NCT01858766|O18|Outcome|SOF+VEL 100 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
125349|NCT01858766|O17|Outcome|SOF+VEL 25 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
125350|NCT01858766|O16|Outcome|SOF+VEL 25 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
125351|NCT01858766|O15|Outcome|SOF+VEL 100 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
125352|NCT01858766|O14|Outcome|SOF+VEL 100 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
125353|NCT01858766|O13|Outcome|SOF+VEL 25 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
125354|NCT01858766|O12|Outcome|SOF+VEL 25 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
125355|NCT01858766|O11|Outcome|SOF+VEL 100 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
125356|NCT01858766|O10|Outcome|SOF+VEL 25 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
125357|NCT01858766|O9|Outcome|SOF+VEL 25 mg 12 Weeks (GT5)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
125358|NCT01858766|O8|Outcome|SOF+VEL 100 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
125468|NCT01857882|B2|Baseline|Standard Care|Routine pre-consultation education
125359|NCT01858766|O7|Outcome|SOF+VEL 25 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
125360|NCT01858766|O6|Outcome|SOF+VEL 100 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
125361|NCT01858766|O5|Outcome|SOF+VEL 25 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
125362|NCT01858766|O4|Outcome|SOF+VEL 100 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
125363|NCT01858766|O3|Outcome|SOF+VEL 25 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
125364|NCT01858766|O2|Outcome|SOF+VEL 100 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
125365|NCT01858766|O1|Outcome|SOF+VEL 25 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
125366|NCT01858766|E6|Reported Event|SOF+VEL 100 mg + RBV 8 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
125367|NCT01858766|E5|Reported Event|SOF+VEL 100 mg 8 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (all genotypes)
125368|NCT01858766|E4|Reported Event|SOF+VEL 25 mg + RBV 8 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
125369|NCT01858766|E3|Reported Event|SOF+VEL 25 mg 8 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (all genotypes)
125370|NCT01858766|E2|Reported Event|SOF+VEL 100 mg 12 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (all genotypes)
125371|NCT01858766|E1|Reported Event|SOF+VEL 25 mg 12 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (all genotypes)
125372|NCT01858701|B1|Baseline|Overall|Lotrafilcon B toric contact lenses and comfilcon A toric contact lenses worn during Period 1 and Period 2 in a crossover assignment.
125373|NCT01858701|P2|Participant Flow|Biofinity Toric / AO for Astig|Comfilcon A toric contact lenses worn in Period 1, followed by lotrafilcon B toric contact lenses in Period 2.
125374|NCT01858701|P1|Participant Flow|AO for Astig / Biofinity Toric|Lotrafilcon B toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses in Period 2.
125375|NCT01858701|O2|Outcome|Biofinity Toric|Comfilcon A toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days.
125376|NCT01858701|O1|Outcome|Air Optix for Astig|Lotrafilcon B toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days.
125377|NCT01858701|E2|Reported Event|Biofinity Toric|Comfilcon A toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days.
125378|NCT01858701|E1|Reported Event|Air Optix for Astig|Lotrafilcon B toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days.
125379|NCT01858636|B1|Baseline|Angio-Seal VIP Vascular Closure|Angio-Seal VIP 6F and 8F devices: These devices are used for the vascular closure procedure
125380|NCT01858636|P1|Participant Flow|Angio-Seal VIP Vascular Closure|Angio-Seal VIP 6 French (6F) and 8 French (8F) devices: These devices are used for the vascular closure procedure
125381|NCT01858636|O1|Outcome|Deployed Subjects|Subjects with Angio-Seal deployed
125382|NCT01858636|O1|Outcome|Deployed Subjects|Percentage of subjects who experienced a major vascular complication during 30-days post procedure.
125383|NCT01858636|E1|Reported Event|Deployed Subjects|Adverse Events (AEs) are provided for all subjects that underwent a study device deployment.
125384|NCT01858545|B3|Baseline|Total|Total of all reporting groups
125385|NCT01858545|B2|Baseline|Comparator|"Cellular Dermal Replacement Tissue~Cellular Dermal Replacement Tissue: Cellular Dermal Replacement Tissue"
125386|NCT01858545|B1|Baseline|Experimental|"MatriStem MicroMatrix and MatriStem Wound Matrix~MatriStem: MatriStem MicroMatrix and MatriStem Wound Matrix"
125387|NCT01858545|P2|Participant Flow|Comparator|"Cellular Dermal Replacement Tissue~Cellular Dermal Replacement Tissue: Cellular Dermal Replacement Tissue"
125388|NCT01858545|P1|Participant Flow|Experimental|"MatriStem MicroMatrix and MatriStem Wound Matrix~MatriStem: MatriStem MicroMatrix and MatriStem Wound Matrix"
125389|NCT01858545|O2|Outcome|Comparator|"Cellular Dermal Replacement Tissue~Cellular Dermal Replacement Tissue: Cellular Dermal Replacement Tissue"
125390|NCT01858545|O1|Outcome|Experimental|"MatriStem MicroMatrix and MatriStem Wound Matrix~MatriStem: MatriStem MicroMatrix and MatriStem Wound Matrix"
125391|NCT01858545|E2|Reported Event|Comparator|"Cellular Dermal Replacement Tissue~Cellular Dermal Replacement Tissue: Cellular Dermal Replacement Tissue"
125392|NCT01858545|E1|Reported Event|Experimental|"MatriStem MicroMatrix and MatriStem Wound Matrix~MatriStem: MatriStem MicroMatrix and MatriStem Wound Matrix"
125393|NCT01858428|B3|Baseline|Total|Total of all reporting groups
125394|NCT01858428|B2|Baseline|Drug-Coated PTA|Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
125395|NCT01858428|B1|Baseline|Bare PTA|EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
125396|NCT01858428|P2|Participant Flow|Drug-Coated PTA|Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
125397|NCT01858428|P1|Participant Flow|Bare PTA|EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
125398|NCT01858428|O2|Outcome|Drug-Coated PTA|Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
125399|NCT01858428|O1|Outcome|Bare PTA|EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
125400|NCT01858428|O2|Outcome|Drug-Coated PTA|Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
125401|NCT01858428|O1|Outcome|Bare PTA|EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
125402|NCT01858428|O2|Outcome|Drug-Coated PTA|Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
125403|NCT01858428|O1|Outcome|Bare PTA|EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
125404|NCT01858428|O2|Outcome|Drug-Coated PTA|Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
125405|NCT01858428|O1|Outcome|Bare PTA|EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
125406|NCT01858428|O2|Outcome|Drug-Coated PTA|Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
125407|NCT01858428|O1|Outcome|Bare PTA|EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
125408|NCT01858428|O2|Outcome|Drug-Coated PTA|Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
125409|NCT01858428|O1|Outcome|Bare PTA|EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
125410|NCT01858428|O2|Outcome|Drug-Coated PTA|Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
125411|NCT01858428|O1|Outcome|Bare PTA|EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
125412|NCT01858428|O2|Outcome|Drug-Coated PTA|Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
125413|NCT01858428|O1|Outcome|Bare PTA|EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
125414|NCT01858428|O2|Outcome|Drug-Coated PTA|Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
125415|NCT01858428|O1|Outcome|Bare PTA|EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
125416|NCT01858428|O2|Outcome|Drug-Coated PTA|Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
125417|NCT01858428|O1|Outcome|Bare PTA|EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
125418|NCT01858428|O2|Outcome|Drug-Coated PTA|Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
125419|NCT01858428|O1|Outcome|Bare PTA|EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
125420|NCT01858428|O2|Outcome|Drug-Coated PTA|Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
125421|NCT01858428|O1|Outcome|Bare PTA|EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
125422|NCT01858428|O2|Outcome|Drug-Coated PTA|Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
125423|NCT01858428|O1|Outcome|Bare PTA|EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
125424|NCT01858428|O2|Outcome|Drug-Coated PTA|Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
125425|NCT01858428|O1|Outcome|Bare PTA|EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
125426|NCT01858428|O2|Outcome|Drug-Coated PTA|Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
125427|NCT01858428|O1|Outcome|Bare PTA|EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
125428|NCT01858428|E2|Reported Event|Drug-Coated PTA|Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
125429|NCT01858428|E1|Reported Event|Bare PTA|EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
125430|NCT01858389|B3|Baseline|Total|Total of all reporting groups
125545|NCT01857297|O2|Outcome|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
126436|NCT01854658|E4|Reported Event|Placebo MDI|Inhaled placebo administered as two puffs BID
125431|NCT01858389|B2|Baseline|Dacomitinib, 45/60 mg, Without T790M Mutation|Participants with no known T790M mutation received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle.
125432|NCT01858389|B1|Baseline|Dacomitinib, 45/60 mg, With T790M Mutation|Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor.
125433|NCT01858389|P2|Participant Flow|Dacomitinib, 45/60 mg, Without T790M Mutation|Participants with no known T790M mutation received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle.
125434|NCT01858389|P1|Participant Flow|Dacomitinib, 45/60 mg, With T790M Mutation|Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor.
125435|NCT01858389|O1|Outcome|Dacomitinib, 45/60 mg|Participants received a 1-week lead-in cycle of dacomitinib, 45 mg, every 12 hours for 6 doses on Days 1-4. Following the lead-in cycle, all participants received intermittent dacomitinib, 60 mg, administered every 12 hours for 6 doses at the beginning of each 2-week cycle.
125436|NCT01858389|O1|Outcome|Dacomitinib, 45 mg|Participants received a 1-week lead-in cycle of dacomitinib, 45 mg, every 12 hours for 6 doses on Days 1-4.
125437|NCT01858389|O1|Outcome|Dacomitinib, 45 mg|Participants received a 1-week lead-in cycle of dacomitinib, 45 mg, every 12 hours for 6 doses on Days 1-4.
125438|NCT01858389|O1|Outcome|Dacomitinib, 45/60 mg, With T790M Mutation|Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor.
125439|NCT01858389|O2|Outcome|Dacomitinib, 45/60 mg, Without T790M Mutation|Participants with no known T790M mutation received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle.
125440|NCT01858389|O1|Outcome|Dacomitinib, 45/60 mg, With T790M Mutation|Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor.
125441|NCT01858389|O2|Outcome|Dacomitinib, 45/60 mg, Without T790M Mutation|Participants with no known T790M mutation received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle.
125442|NCT01858389|O1|Outcome|Dacomitinib, 45/60 mg, With T790M Mutation|Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor.
125443|NCT01858389|O1|Outcome|Dacomitinib, 45/60 mg, With T790M Mutation|Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor.
125444|NCT01858389|O1|Outcome|Dacomitinib, 45/60 mg, With T790M Mutation|Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor.
125445|NCT01858389|O1|Outcome|Dacomitinib, 45/60 mg, With T790M Mutation|Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor.
125446|NCT01858389|E2|Reported Event|Dacomitinib, 45/60 mg, Without T790M Mutation|Participants with no known T790M mutation received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle.
125447|NCT01858389|E1|Reported Event|Dacomitinib, 45/60 mg, With T790M Mutation|Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor.
125488|NCT01857622|P2|Participant Flow|Normal/MiRI Low-dose Group|"Normal or Mild Renal impairment DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 30mg: oral DU-176b 30mg once daily"
125448|NCT01858376|B1|Baseline|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.~Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws, 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
125449|NCT01858376|P1|Participant Flow|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.~Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
125450|NCT01858376|O1|Outcome|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.~Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
125451|NCT01858376|O1|Outcome|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.~Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
125452|NCT01858376|O1|Outcome|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.~Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
125453|NCT01858376|E1|Reported Event|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.~Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
125454|NCT01857986|B3|Baseline|Total|Total of all reporting groups
125455|NCT01857986|B2|Baseline|Control|Control patients were connected to the AnapnoGuard 100 system, with automatic, periodical rinsing and suction of subglottic secretions, while the cuff pressure control was not active (turned OFF). In the control group, the system recorded the CO2 levels in the subglottic space, but cuff pressure was managed manually using a manometer 3 times daily.
125456|NCT01857986|B1|Baseline|Study|Study patients were connected to the AnapnoGuard 100 system, using all functional modalities: active cuff pressure control, using subglottic CO2 readings as an indicator for leaks and automatic, periodic rinsing and suction of subglottic secretions.
125457|NCT01857986|P2|Participant Flow|Control|Control patients were connected to the AnapnoGuard 100 system, with automatic, periodical rinsing and suction of subglottic secretions, while the cuff pressure control was not active (turned OFF). In the control group, the system recorded the CO2 levels in the subglottic space, but cuff pressure was managed manually using a manometer 3 times daily.
125458|NCT01857986|P1|Participant Flow|Study|Study patients were connected to the AnapnoGuard 100 system, using all functional modalities: active cuff pressure control, using subglottic CO2 readings as an indicator for leaks and automatic, periodic rinsing and suction of subglottic secretions.
125459|NCT01857986|O2|Outcome|Control|Control patients were connected to the AnapnoGuard 100 system, with automatic, periodical rinsing and suction of subglottic secretions, while the cuff pressure control was not active (turned OFF). In the control group, the system recorded the CO2 levels in the subglottic space, but cuff pressure was managed manually using a manometer 3 times daily.
125460|NCT01857986|O1|Outcome|Study|Study patients were connected to the AnapnoGuard 100 system, using all functional modalities: active cuff pressure control, using subglottic CO2 readings as an indicator for leaks and automatic, periodic rinsing and suction of subglottic secretions.
125461|NCT01857986|O2|Outcome|Control|Control patients were connected to the AnapnoGuard 100 system, with automatic, periodical rinsing and suction of subglottic secretions, while the cuff pressure control was not active (turned OFF). In the control group, the system recorded the CO2 levels in the subglottic space, but cuff pressure was managed manually using a manometer 3 times daily.
125462|NCT01857986|O1|Outcome|Study|Study patients were connected to the AnapnoGuard 100 system, using all functional modalities: active cuff pressure control, using subglottic CO2 readings as an indicator for leaks and automatic, periodic rinsing and suction of subglottic secretions.
125463|NCT01857986|O2|Outcome|Control|Control patients were connected to the AnapnoGuard 100 system, with automatic, periodical rinsing and suction of subglottic secretions, while the cuff pressure control was not active (turned OFF). In the control group, the system recorded the CO2 levels in the subglottic space, but cuff pressure was managed manually using a manometer 3 times daily.
125464|NCT01857986|O1|Outcome|Study|Study patients were connected to the AnapnoGuard 100 system, using all functional modalities: active cuff pressure control, using subglottic CO2 readings as an indicator for leaks and automatic, periodic rinsing and suction of subglottic secretions.
125465|NCT01857986|E2|Reported Event|Control|
125466|NCT01857986|E1|Reported Event|Study|
125469|NCT01857882|B1|Baseline|Decision Support Workshop|"The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.~Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.~Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities~Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system~Social worker (30 mins): values clarification exercise~Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience"
125470|NCT01857882|P2|Participant Flow|Standard Care|Routine pre-consultation education
125471|NCT01857882|P1|Participant Flow|Decision Support Workshop|"The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.~Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.~Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities~Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system~Social worker (30 mins): values clarification exercise~Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience"
125472|NCT01857882|O2|Outcome|Standard Care|Routine pre-consultation education
125473|NCT01857882|O1|Outcome|Decision Support Workshop|"The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.~Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.~Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities~Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system~Social worker (30 mins): values clarification exercise~Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience"
125474|NCT01857882|E2|Reported Event|Standard Care|Routine pre-consultation education
125475|NCT01857882|E1|Reported Event|Decision Support Workshop|"The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.~Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.~Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities~Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system~Social worker (30 mins): values clarification exercise~Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience"
125476|NCT01857713|B1|Baseline|Fitted With Reza Band UES Assist Device|Patients were their own control and Fitted with Reza Band UES Assist Device. Results were obtained by measuring symptoms at baseline and then compared at each of the prescribed follow-up visits.
125477|NCT01857713|P1|Participant Flow|Fitted With Reza Band UES Assist Device|Patients were fitted with the Reza Band UES Assist Device and served as their own control. Baseline measures were comported to follow-up visit measures.
125478|NCT01857713|O1|Outcome|Fitted With Reza Band UES Assist Device|Patients were fitted with the Reza Band UES Assist Device and Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).
125479|NCT01857713|O1|Outcome|Fitted With Reza Band UES Assist Device|Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).
125480|NCT01857713|O1|Outcome|Fitted With Reza Band UES Assist Device|Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).
125481|NCT01857713|O1|Outcome|Reza Band|Participants fitted with Reza Band UES Assist Device
125482|NCT01857713|E1|Reported Event|Fitted With Reza Band UES Assist Device|Patients were fitted with the Reza Band UES Assist Device and were their own controls. Baseline measures were compared to each of the prescribed follow-up visit measures.
125483|NCT01857622|B4|Baseline|Total|Total of all reporting groups
125484|NCT01857622|B3|Baseline|Normal/MiRI High-dose Group|"Normal or Mild Renal Impairment DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 60mg: oral DU-176b 60mg once daily"
125485|NCT01857622|B2|Baseline|Normal/MiRI Low-dose Group|"Normal or Mild Renal impairment DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 30mg: oral DU-176b 30mg once daily"
125486|NCT01857622|B1|Baseline|SRI 15mg|"Severe Renal Impairment DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.~DU-176b 15mg: oral DU-176b 15mg once daily"
125487|NCT01857622|P3|Participant Flow|Normal/MiRI High-dose Group|"Normal or Mild Renal Impairment DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 60mg: oral DU-176b 60mg once daily"
125489|NCT01857622|P1|Participant Flow|SRI 15mg|"Severe Renal Impairment DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.~DU-176b 15mg: oral DU-176b 15mg once daily"
125490|NCT01857622|O3|Outcome|Normal/MiRI High-dose Group|"Normal or Mild Renal Impairment DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 60mg: oral DU-176b 60mg once daily"
125491|NCT01857622|O2|Outcome|Normal/MiRI Low-dose Group|"Normal or Mild Renal impairment DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 30mg: oral DU-176b 30mg once daily"
125492|NCT01857622|O1|Outcome|SRI 15mg|"Severe Renal Impairment DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.~DU-176b 15mg: oral DU-176b 15mg once daily"
125493|NCT01857622|E3|Reported Event|Normal/MiRI High-dose Group|"Normal or Mild Renal Impairment DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 60mg: oral DU-176b 60mg once daily"
125494|NCT01857622|E2|Reported Event|Normal/MiRI Low-dose Group|"Normal or Mild Renal impairment DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 30mg: oral DU-176b 30mg once daily"
125495|NCT01857622|E1|Reported Event|SRI 15mg|"Severe Renal Impairment DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.~DU-176b 15mg: oral DU-176b 15mg once daily"
125496|NCT01857583|B5|Baseline|Total|Total of all reporting groups
125497|NCT01857583|B4|Baseline|Fondaparinux (20 mL/Min ≤ CLCR < 30mL/Min)|"Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days.~(20 mL/min ≤ CLCR < 30mL/min)"
125498|NCT01857583|B3|Baseline|SRI 15mg DU176b (20 mL/Min ≤ CLCR < 30 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU176b once daily for 14 days.~(20 mL/min ≤ CLCR < 30 mL/min) 15mg DU-176b"
125499|NCT01857583|B2|Baseline|SRI 15mg DU176b (15 mL/Min ≤ CLCR < 20 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.~(15 mL/min ≤ CLCR < 20 mL/min) 15mg DU-176b"
125500|NCT01857583|B1|Baseline|MiRI 30mg DU176b (50 mL/Min ≤ CLCR ≤ 80 mL/Min)|"Mild Renal Impairment group orally administered 30mg DU176b once daily for 14 days.~(50 mL/min ≤ CLCR ≤ 80 mL/min) 30mg DU-176b"
125501|NCT01857583|P4|Participant Flow|Fondaparinux (20 mL/Min ≤ CLCR < 30mL/Min)|"Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days.~(20 mL/min ≤ CLCR < 30mL/min) Fondaparinux"
125502|NCT01857583|P3|Participant Flow|SRI 15mg DU176b (20 mL/Min ≤ CLCR < 30 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU176b once daily for 14 days.~(20 mL/min ≤ CLCR < 30 mL/min) 15mg DU-176b"
125503|NCT01857583|P2|Participant Flow|SRI 15mg DU176b (15 mL/Min ≤ CLCR < 20 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.~(15 mL/min ≤ CLCR < 20 mL/min) 15mg DU-176b"
125504|NCT01857583|P1|Participant Flow|MiRI 30mg DU176b (50 mL/Min ≤ CLCR ≤ 80mL/Min)|"Mild Renal Impairment group orally administered 30mg DU176b once daily for 14 days.~(50 mL/min ≤ CLCR ≤ 80 mL/min) 30mg DU-176b"
125505|NCT01857583|O4|Outcome|Fondaparinux (20 mL/Min ≤ CLCR < 30mL/Min)|"Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days.~(20 mL/min ≤ CLCR < 30mL/min)"
125506|NCT01857583|O3|Outcome|SRI 15mg DU 176b (20 mL/Min ≤ CLCR < 30 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU176b once daily for 14 days.~(20 mL/min ≤ CLCR < 30 mL/min) 15mg DU-176b"
125507|NCT01857583|O2|Outcome|SRI 15mg DU 176b (15 mL/Min ≤ CLCR < 20 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.~(15 mL/min ≤ CLCR < 20 mL/min) 15mg DU-176b"
125508|NCT01857583|O1|Outcome|MiRI 30mg DU 176b (50 mL/Min ≤ CLCR ≤ 80 mL/Min)|"Mild Renal Impairment group orally administered 30mg DU176b once daily for 14 days.~(50 mL/min ≤ CLCR ≤ 80 mL/min) 30mg DU-176b"
125509|NCT01857583|E4|Reported Event|Fondaparinux (20 mL/Min ≤ CLCR < 30mL/Min)|"Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days.~Fondaparinux (20 mL/min ≤ CLCR < 30mL/min)"
125510|NCT01857583|E3|Reported Event|SRI 15mg DU 176b (20 mL/Min ≤ CLCR < 30 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU176b once daily for 14 days.~(20 mL/min ≤ CLCR < 30 mL/min) 15mg DU-176b"
125511|NCT01857583|E2|Reported Event|SRI 15mg DU 176b (15 mL/Min ≤ CLCR < 20 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.~(15 mL/min ≤ CLCR < 20 mL/min) 15mg DU-176b"
125512|NCT01857583|E1|Reported Event|MiRI 30mg DU 176b (50 mL/Min ≤ CLCR ≤ 80 mL/Min)|"Mild Renal Impairment group orally administered 30mg DU176b once daily for 14 days.~(50 mL/min ≤ CLCR ≤ 80 mL/min) 30mg DU-176b"
125513|NCT01857531|B1|Baseline|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily for the first 3 days, 800mg daily for the next 3 days and 1200mg daily for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
125514|NCT01857531|P1|Participant Flow|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
125543|NCT01857297|P2|Participant Flow|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
125544|NCT01857297|P1|Participant Flow|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
125515|NCT01857531|O1|Outcome|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
125516|NCT01857531|O1|Outcome|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
125517|NCT01857531|O1|Outcome|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
125518|NCT01857531|O1|Outcome|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
125519|NCT01857531|O1|Outcome|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
125520|NCT01857531|O1|Outcome|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
125521|NCT01857531|E1|Reported Event|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
125522|NCT01857362|B1|Baseline|Overall Study|All treatment arms
125523|NCT01857362|P2|Participant Flow|Nitisinone 2 x 10 mg, Then Nitisinone 1 x 20 mg|Participants first received two nitisinone capsules of 10 mg. After washout of 3 weeks participants then received one nitisinone capsule of 20 mg.
125524|NCT01857362|P1|Participant Flow|Nitisinone 1 x 20 mg, Then Nitisinone 2 x 10 mg|Participants first received one nitisinone capsule of 20 mg. After washout of 3 weeks participants then received two nitisinone capsules of 10 mg.
125525|NCT01857362|O2|Outcome|Nitisinone 1 x 20 mg Capsules|Nitisinone 1 x 20 mg capsules
125526|NCT01857362|O1|Outcome|Nitisinone 2 x 10 mg Capsules|Nitisinone 2 x 10 mg capsules
125527|NCT01857362|O2|Outcome|Nitisinone 1 x 20 mg Capsules|Nitisinone 1 x 20 mg capsules
125528|NCT01857362|O1|Outcome|Nitisinone 2 x 10 mg Capsules|Nitisinone 2 x 10 mg capsules
125529|NCT01857362|E2|Reported Event|Nitisinone 1 x 20 mg Capsules|Nitisinone 1 x 20 mg capsules
125530|NCT01857362|E1|Reported Event|Nitisinone 2 x 10 mg Capsules|Nitisinone 2 x 10 mg capsules
125531|NCT01857323|B1|Baseline|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
125532|NCT01857323|P1|Participant Flow|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
125533|NCT01857323|O1|Outcome|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
125534|NCT01857323|O1|Outcome|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
125535|NCT01857323|O1|Outcome|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
125536|NCT01857323|O1|Outcome|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
125537|NCT01857323|O1|Outcome|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
125538|NCT01857323|O1|Outcome|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
125539|NCT01857323|E1|Reported Event|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
125540|NCT01857297|B3|Baseline|Total|Total of all reporting groups
125541|NCT01857297|B2|Baseline|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
125542|NCT01857297|B1|Baseline|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
125546|NCT01857297|O1|Outcome|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
125547|NCT01857297|O2|Outcome|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
125548|NCT01857297|O1|Outcome|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
125549|NCT01857297|O2|Outcome|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
125550|NCT01857297|O1|Outcome|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
125551|NCT01857297|O2|Outcome|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
125552|NCT01857297|O1|Outcome|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
125553|NCT01857297|O2|Outcome|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
125554|NCT01857297|O1|Outcome|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
125555|NCT01857297|E2|Reported Event|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
125556|NCT01857297|E1|Reported Event|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
125557|NCT01857258|B1|Baseline|Baseline Participant Characteristics|All participants completed both arms of the cross-over study
125558|NCT01857258|P2|Participant Flow|Control First, Then Green Tea|"Participants will be provided a confection devoid of green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection containing green tea concentrate in fasting state one time.~The green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose. The confection provides 50 grams of starch and 1 gram of green tea concentrate."
125559|NCT01857258|P1|Participant Flow|Green Tea First, Then Control|"Participants will be provided a confection containing green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection devoid of green tea concentrate in fasting state one time.~The green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose. The confection provides 50 grams of starch and 1 gram of green tea concentrate."
125560|NCT01857258|O2|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
125561|NCT01857258|O1|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
125562|NCT01857258|O2|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
125563|NCT01857258|O1|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
125564|NCT01857258|O2|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
125565|NCT01857258|O1|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
125566|NCT01857258|O2|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
125567|NCT01857258|O1|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
125568|NCT01857258|O2|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
125569|NCT01857258|O1|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
125570|NCT01857258|O2|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
125571|NCT01857258|O1|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
125572|NCT01857258|O2|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
125573|NCT01857258|O1|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
125607|NCT01857102|E1|Reported Event|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
125574|NCT01857258|O2|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
125575|NCT01857258|O1|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
125576|NCT01857258|E2|Reported Event|Control, Then Green Tea|"Participants will be provided a confection devoid of green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection containing green tea concentrate in fasting state one time.~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
125577|NCT01857258|E1|Reported Event|Green Tea, Then Control|"Participants will be provided a confection containing green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection devoid of green tea concentrate in fasting state one time.~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
125578|NCT01857206|B3|Baseline|TOTAL|Total of all reporting groups
125579|NCT01857206|B2|Baseline|TIVf|Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
125580|NCT01857206|B1|Baseline|TIVc|Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
125581|NCT01857206|P2|Participant Flow|TIVf|Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
125582|NCT01857206|P1|Participant Flow|TIVc|Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
125583|NCT01857206|O4|Outcome|TIVf (≥9 to ≤17 Years)|Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
125584|NCT01857206|O3|Outcome|TIVc (≥9 to ≤17 Years)|Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
125585|NCT01857206|O2|Outcome|TIVf (≥4 to ≤8 Years)|Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
125586|NCT01857206|O1|Outcome|TIVc (≥4 to ≤8 Years)|Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
125587|NCT01857206|O4|Outcome|TIVf (≥9 to ≤17 Years)|Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
125588|NCT01857206|O3|Outcome|TIVc (≥9 to ≤17 Years)|Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
125589|NCT01857206|O2|Outcome|TIVf (≥4 to ≤8 Years)|Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
125590|NCT01857206|O1|Outcome|TIVc (≥4 to ≤8 Years)|Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
125591|NCT01857206|O4|Outcome|TIVf (≥9 to ≤17 Years)|Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
125592|NCT01857206|O3|Outcome|TIVc (≥9 to ≤17 Years)|Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
125593|NCT01857206|O2|Outcome|TIVf (≥4 to ≤8 Years)|Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
125594|NCT01857206|O1|Outcome|TIVc (≥4 to ≤8 Years)|Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
125595|NCT01857206|E4|Reported Event|TIVf(9-17Years )|Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
125596|NCT01857206|E3|Reported Event|TIVc(9-17Years )|Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
125597|NCT01857206|E2|Reported Event|TIVf(4-8Years )|Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
125598|NCT01857206|E1|Reported Event|TIVc(4-8Years )|Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
125599|NCT01857102|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens.
125600|NCT01857102|P2|Participant Flow|Etafilcon A for Astigmatism/Etafilcon A|Subjects that first received the etafilcon A for Astigmatism lens and then received the etafilcon A lens.
125601|NCT01857102|P1|Participant Flow|Etafilcon A/ Etafilcon A for Astigmatism|Subjects that first received the etafilcon A lens and then received the etafilcon A for Astigmatism lens.
125602|NCT01857102|O2|Outcome|Etafilcon A for Astigmatism|Subjects that received etafilcon A for Astigmatism lens in either the first or second period of the study.
125603|NCT01857102|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A lens during the first or second period of the study.
125604|NCT01857102|O2|Outcome|Etafilcon A for Astigmatism|Subjects that received the etafilcon A for Astigmatism lens in either the first or second period of the study.
125605|NCT01857102|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
125606|NCT01857102|E2|Reported Event|Etafilcon A for Astigmatism|Subjects that received the etafilcon A for Astigmatism lens in either the first or second period of the study.
125608|NCT01857063|B3|Baseline|Total|Total of all reporting groups
125609|NCT01857063|B2|Baseline|Placebo/Montelukast|Participants receive placebo chewable tablets for 7 days during Period 1 and receive montelukast 5 mg chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.
125610|NCT01857063|B1|Baseline|Montelukast/Placebo|Participants receive montelukast 5 mg chewable tablets for 7 days during Period 1 and receive placebo chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.
125611|NCT01857063|P2|Participant Flow|Placebo/Montelukast|Participants receive placebo chewable tablets for 7 days during Period 1 and receive montelukast 5 mg chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.
125612|NCT01857063|P1|Participant Flow|Montelukast/Placebo|Participants receive montelukast 5 mg chewable tablets for 7 days during Period 1 and receive placebo chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.
125613|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
125614|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
125615|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
125616|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
125617|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
125618|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
125619|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
125620|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
125621|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
125622|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
125623|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
125624|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
125625|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
125626|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
125627|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
125628|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
125629|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
125630|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
125631|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
125632|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
125633|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
125634|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
125635|NCT01857063|E2|Reported Event|Placebo|Participants receive placebo for 7 days, regardless of sequence.
125636|NCT01857063|E1|Reported Event|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
125637|NCT01856933|B1|Baseline|PSMA ADC|"2.5 mg/kg, IV, over 60 minutes every 3 weeks~PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks"
125638|NCT01856933|P1|Participant Flow|PSMA ADC|"2.5 mg/kg, IV, over 60 minutes every 3 weeks~PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks"
125639|NCT01856933|O1|Outcome|PSMA ADC|"2.5 mg/kg, IV, over 60 minutes every 3 weeks~PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks"
125640|NCT01856933|E1|Reported Event|PSMA ADC|"2.5 mg/kg, IV, over 60 minutes every 3 weeks~PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks"
125641|NCT01856907|B4|Baseline|Total|Total of all reporting groups
125642|NCT01856907|B3|Baseline|Metformin|"1000 mg BID~Metformin: Biguanide- insulin sensitizer"
125643|NCT01856907|B2|Baseline|Placebo Pill|"1 pill/BID for 16 weeks~Placebo pill: Will evaluate effect of lifestyle and diet only"
125644|NCT01856907|B1|Baseline|Sitagliptin-Metformin|"50 mg/1000 mg BID~Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication"
125645|NCT01856907|P3|Participant Flow|Metformin|"1000 mg BID~Metformin: Biguanide- insulin sensitizer"
125646|NCT01856907|P2|Participant Flow|Placebo Pill|"1 pill/BID for 16 weeks~Placebo pill: Will evaluate effect of lifestyle and diet only"
125647|NCT01856907|P1|Participant Flow|Sitagliptin-Metformin|"50 mg/1000 mg BID~Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication"
125648|NCT01856907|O3|Outcome|Metformin|"1000 mg BID~Metformin: Biguanide- insulin sensitizer"
125649|NCT01856907|O2|Outcome|Placebo Pill|"1 pill/BID for 16 weeks~Placebo pill: Will evaluate effect of lifestyle and diet only"
125650|NCT01856907|O1|Outcome|Sitagliptin-Metformin|"50 mg/1000 mg BID~Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication"
125651|NCT01856907|O3|Outcome|Metformin|"1000 mg BID~Metformin: Biguanide- insulin sensitizer"
125652|NCT01856907|O2|Outcome|Placebo Pill|"1 pill/BID for 16 weeks~Placebo pill: Will evaluate effect of lifestyle and diet only"
125653|NCT01856907|O1|Outcome|Sitagliptin-Metformin|"50 mg/1000 mg BID~Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication"
125654|NCT01856907|O3|Outcome|Metformin|"1000 mg BID~Metformin: Biguanide- insulin sensitizer"
125655|NCT01856907|O2|Outcome|Placebo Pill|"1 pill/BID for 16 weeks~Placebo pill: Will evaluate effect of lifestyle and diet only"
125656|NCT01856907|O1|Outcome|Sitagliptin-Metformin|"50 mg/1000 mg BID~Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication"
125657|NCT01856907|O3|Outcome|Metformin|"1000 mg BID~Metformin: Biguanide- insulin sensitizer"
125658|NCT01856907|O2|Outcome|Placebo Pill|"1 pill/BID for 16 weeks~Placebo pill: Will evaluate effect of lifestyle and diet only"
125659|NCT01856907|O1|Outcome|Sitagliptin-Metformin|"50 mg/1000 mg BID~Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication"
125660|NCT01856907|O3|Outcome|Metformin|"1000 mg BID~Metformin: Biguanide- insulin sensitizer"
125662|NCT01856907|O1|Outcome|Sitagliptin-Metformin|"50 mg/1000 mg BID~Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication"
125663|NCT01856907|O3|Outcome|Metformin|"1000 mg BID~Metformin: Biguanide- insulin sensitizer"
125664|NCT01856907|O2|Outcome|Placebo Pill|"1 pill/BID for 16 weeks~Placebo pill: Will evaluate effect of lifestyle and diet only"
125665|NCT01856907|O1|Outcome|Sitagliptin-Metformin|"50 mg/1000 mg BID~Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication"
125666|NCT01856907|O3|Outcome|Metformin|"1000 mg BID~Metformin: Biguanide- insulin sensitizer"
125667|NCT01856907|O2|Outcome|Placebo Pill|"1 pill/BID for 16 weeks~Placebo pill: Will evaluate effect of lifestyle and diet only"
125668|NCT01856907|O1|Outcome|Sitagliptin-Metformin|"50 mg/1000 mg BID~Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication"
125669|NCT01856907|O3|Outcome|Metformin|"1000 mg BID~Metformin: Biguanide- insulin sensitizer"
125670|NCT01856907|O2|Outcome|Placebo Pill|"1 pill/BID for 16 weeks~Placebo pill: Will evaluate effect of lifestyle and diet only"
125671|NCT01856907|O1|Outcome|Sitagliptin-Metformin|"50 mg/1000 mg BID~Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication"
125672|NCT01856907|O3|Outcome|Metformin|"1000 mg BID~Metformin: Biguanide- insulin sensitizer"
125673|NCT01856907|O2|Outcome|Placebo Pill|"1 pill/BID for 16 weeks~Placebo pill: Will evaluate effect of lifestyle and diet only"
125674|NCT01856907|O1|Outcome|Sitagliptin-Metformin|"50 mg/1000 mg BID~Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication"
125675|NCT01856907|O3|Outcome|Metformin|"1000 mg BID~Metformin: Biguanide- insulin sensitizer"
125676|NCT01856907|O2|Outcome|Placebo Pill|"1 pill/BID for 16 weeks~Placebo pill: Will evaluate effect of lifestyle and diet only"
125677|NCT01856907|O1|Outcome|Sitagliptin-Metformin|"50 mg/1000 mg BID~Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication"
125678|NCT01856907|O3|Outcome|Metformin|"1000 mg twice a day (BID)~Metformin: Biguanide- insulin sensitizer"
125679|NCT01856907|O2|Outcome|Placebo Pill|"1 pill/ twice a day (BID) for 16 weeks~Placebo pill: Will evaluate effect of lifestyle and diet only"
125680|NCT01856907|O1|Outcome|Sitagliptin-Metformin|"50 mg/1000 mg twice a day (BID)~Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication"
125681|NCT01856907|E3|Reported Event|Metformin|"1000 mg BID~Metformin: Biguanide- insulin sensitizer"
125682|NCT01856907|E2|Reported Event|Placebo Pill|"1 pill/BID for 16 weeks~Placebo pill: Will evaluate effect of lifestyle and diet only"
125683|NCT01856907|E1|Reported Event|Sitagliptin-Metformin|"50 mg/1000 mg BID~Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication"
125684|NCT01856764|B3|Baseline|Total|Total of all reporting groups
125685|NCT01856764|B2|Baseline|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
125686|NCT01856764|B1|Baseline|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
125687|NCT01856764|P2|Participant Flow|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
125688|NCT01856764|P1|Participant Flow|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
125689|NCT01856764|O2|Outcome|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
125690|NCT01856764|O1|Outcome|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
125691|NCT01856764|O2|Outcome|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
125692|NCT01856764|O1|Outcome|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
125693|NCT01856764|O2|Outcome|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
125694|NCT01856764|O1|Outcome|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
125695|NCT01856764|E2|Reported Event|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
125696|NCT01856764|E1|Reported Event|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
125697|NCT01856686|B3|Baseline|Total|Total of all reporting groups
125698|NCT01856686|B2|Baseline|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
125699|NCT01856686|B1|Baseline|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
125700|NCT01856686|P2|Participant Flow|Low Carbohydrate Diet|This group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements
125701|NCT01856686|P1|Participant Flow|BP22042013|This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
125702|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
125703|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
125704|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
125705|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
125706|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
125707|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
125708|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
125709|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
125710|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
125711|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
125712|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
125713|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
125714|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
125715|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
125716|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
125717|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
125718|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
125719|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
125720|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
125721|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
125722|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
125723|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
125724|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
125725|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
125726|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
125773|NCT01856530|O1|Outcome|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
125727|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
125728|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
125729|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
125730|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
125731|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
125732|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
125733|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
125734|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
125735|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
125736|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
125737|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
125738|NCT01856686|E2|Reported Event|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
125739|NCT01856686|E1|Reported Event|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
125740|NCT01856673|B4|Baseline|Total|Total of all reporting groups
125741|NCT01856673|B3|Baseline|ARM 3: Standby Group|"Standby group without intervention, but under monthly monitoring.~Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then an exit assessment will be performed with the study instrument. After the exit survey, control group participants will have an appointment with a professional psychologist to determine whether they require a mental health treatment. Those with such necessity will receive treatment in the ACOPLE center by professional psychologists or they will be referred to other health care level according to the type of psychopathology (e.g., psychosis) or its severity. Also, participants in the control group will be monitoring monthly by phone calls and if they have any psychological problem, they will be assessed in the ACOPLE center."
125742|NCT01856673|B2|Baseline|ARM 2: Community Group Therapy|"Community Group Therapy (CGT) only~Community Therapy Intervention: It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by MHCW under constant supervision of mental health professionals (psychologists or social workers). Sessions will begin with a series of introductory activities that motivates participants to propose different problems that they would like to solve in the group. A participant proposed a problem and he/she will be asked to talk about it. MHCW and/or psychologist will support individuals if anyone needs help to solve a psychological crisis. At the end of this narration, participants will be asked about who has had a similar situation, and how they solved it. In this way, proposed solutions will be collected by the MHCW. Finally, session closes with a motivating activity."
125743|NCT01856673|B1|Baseline|ARM 1: Common Elements Treatment Approach|"Common Elements Treatment Approach (CETA) only~Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and panel of experts. Descriptions and schemes have been developed in order to guarantee facility of use by community counselors who have little background in mental health skills. These counselors, who will be called Mental Health Community Workers (MHCW), will receive training in this technique before beginning of interventions. Application of this technique will be supervised constantly by mental health professionals (psychologist or social worker) from the project team."
125774|NCT01856530|O2|Outcome|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
125775|NCT01856530|O1|Outcome|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
125744|NCT01856673|P3|Participant Flow|ARM 3: Standby Group|"Standby group without intervention, but under monthly monitoring.~Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then an exit assessment will be performed with the study instrument. After the exit survey, control group participants will have an appointment with a professional psychologist to determine whether they require a mental health treatment. Those with such necessity will receive treatment in the ACOPLE center by professional psychologists or they will be referred to other health care level according to the type of psychopathology (e.g., psychosis) or its severity. Also, participants in the control group will be monitoring monthly by phone calls and if they have any psychological problem, they will be assessed in the ACOPLE center."
125745|NCT01856673|P2|Participant Flow|ARM 2: Narrative Community Group Therapy|"Narrative Community Group Therapy (NCGT) only~Community Therapy Intervention: It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by LPCW under constant supervision of mental health professionals (psychologists or social workers). Sessions will begin with a series of introductory activities that motivates participants to propose different problems that they would like to solve in the group. A participant proposed a problem and he/she will be asked to talk about it. LPCW and/or psychologist will support individuals if anyone needs help to solve a psychological crisis. At the end of this narration, participants will be asked about who has had a similar situation, and how they solved it. In this way, proposed solutions will be collected by the LPCW. Finally, session closes with a motivating activity."
125746|NCT01856673|P1|Participant Flow|ARM 1: Common Elements Treatment Approach|"Common Elements Treatment Approach (CETA) only~Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and panel of experts. Descriptions and schemes have been developed in order to guarantee facility of use by community counselors who have little background in mental health skills. These counselors, who will be called Lay Psychosocial Community Workers (LPCW), will receive training in this technique before beginning of interventions. Application of this technique will be supervised constantly by mental health professionals (psychologist or social worker) from the project team."
125747|NCT01856673|O3|Outcome|ARM 3: Standby Group|"Standby group without intervention, but under monthly monitoring.~Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then an exit assessment will be performed with the study instrument. After the exit survey, control group participants will have an appointment with a professional psychologist to determine whether they require a mental health treatment. Those with such necessity will receive treatment in the ACOPLE center by professional psychologists or they will be referred to other health care level according to the type of psychopathology (e.g., psychosis) or its severity. Also, participants in the control group will be monitoring monthly by phone calls and if they have any psychological problem, they will be assessed in the ACOPLE center."
125748|NCT01856673|O2|Outcome|ARM 2: Narrative Community Group Therapy|"Narrative Community Group Therapy (NCGT) only~Narrative Community Therapy Intervention: It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by LPCW under constant supervision of mental health professionals (psychologists or social workers). Sessions will begin with a series of introductory activities that motivates participants to propose different problems that they would like to solve in the group. A participant proposed a problem and he/she will be asked to talk about it. LPCW and/or psychologist will support individuals if anyone needs help to solve a psychological crisis. At the end of this narration, participants will be asked about who has had a similar situation, and how they solved it. In this way, proposed solutions will be collected by the LPCW. Finally, session closes with a motivating activity."
125749|NCT01856673|O1|Outcome|ARM 1: Common Elements Treatment Approach|"Common Elements Treatment Approach (CETA) only~Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and panel of experts. Descriptions and schemes have been developed in order to guarantee facility of use by community counselors who have little background in mental health skills. These counselors, who will be called Lay Psychosocial Community Workers (LPCW), will receive training in this technique before beginning of interventions. Application of this technique will be supervised constantly by mental health professionals (psychologist or social worker) from the project team."
125750|NCT01856673|O3|Outcome|ARM 3: Standby Group|"Standby group without intervention, but under monthly monitoring.~Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then an exit assessment will be performed with the study instrument. After the exit survey, control group participants will have an appointment with a professional psychologist to determine whether they require a mental health treatment. Those with such necessity will receive treatment in the ACOPLE center by professional psychologists or they will be referred to other health care level according to the type of psychopathology (e.g., psychosis) or its severity. Also, participants in the control group will be monitoring monthly by phone calls and if they have any psychological problem, they will be assessed in the ACOPLE center."
125751|NCT01856673|O2|Outcome|ARM 2: Narrative Community Group Therapy|"Narrative Community Group Therapy (NCGT) only~Narrative Community Therapy Intervention: It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by LPCW under constant supervision of mental health professionals (psychologists or social workers). Sessions will begin with a series of introductory activities that motivates participants to propose different problems that they would like to solve in the group. A participant proposed a problem and he/she will be asked to talk about it. LPCW and/or psychologist will support individuals if anyone needs help to solve a psychological crisis. At the end of this narration, participants will be asked about who has had a similar situation, and how they solved it. In this way, proposed solutions will be collected by the LPCW. Finally, session closes with a motivating activity."
125776|NCT01856530|O2|Outcome|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
125777|NCT01856530|O1|Outcome|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
125778|NCT01856530|O2|Outcome|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
125752|NCT01856673|O1|Outcome|ARM 1: Common Elements Treatment Approach|"Common Elements Treatment Approach (CETA) only~Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and panel of experts. Descriptions and schemes have been developed in order to guarantee facility of use by community counselors who have little background in mental health skills. These counselors, who will be called Lay Psychosocial Community Workers (LPCW), will receive training in this technique before beginning of interventions. Application of this technique will be supervised constantly by mental health professionals (psychologist or social worker) from the project team."
125753|NCT01856673|E3|Reported Event|ARM 3: Standby Group|"Standby group without intervention, but under monthly monitoring.~Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then an exit assessment will be performed with the study instrument. After the exit survey, control group participants will have an appointment with a professional psychologist to determine whether they require a mental health treatment. Those with such necessity will receive treatment in the ACOPLE center by professional psychologists or they will be referred to other health care level according to the type of psychopathology (e.g., psychosis) or its severity. Also, participants in the control group will be monitoring monthly by phone calls and if they have any psychological problem, they will be assessed in the ACOPLE center."
125754|NCT01856673|E2|Reported Event|ARM 2: Community Group Therapy|"Community Group Therapy (CGT) only~Community Therapy Intervention: It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by MHCW under constant supervision of mental health professionals (psychologists or social workers). Sessions will begin with a series of introductory activities that motivates participants to propose different problems that they would like to solve in the group. A participant proposed a problem and he/she will be asked to talk about it. MHCW and/or psychologist will support individuals if anyone needs help to solve a psychological crisis. At the end of this narration, participants will be asked about who has had a similar situation, and how they solved it. In this way, proposed solutions will be collected by the MHCW. Finally, session closes with a motivating activity."
125755|NCT01856673|E1|Reported Event|ARM 1: Common Elements Treatment Approach|"Common Elements Treatment Approach (CETA) only~Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and panel of experts. Descriptions and schemes have been developed in order to guarantee facility of use by community counselors who have little background in mental health skills. These counselors, who will be called Mental Health Community Workers (MHCW), will receive training in this technique before beginning of interventions. Application of this technique will be supervised constantly by mental health professionals (psychologist or social worker) from the project team."
125756|NCT01856569|B1|Baseline|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
125757|NCT01856569|P1|Participant Flow|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
125758|NCT01856569|O1|Outcome|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
125759|NCT01856569|O1|Outcome|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
125760|NCT01856569|O1|Outcome|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
125761|NCT01856569|O1|Outcome|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
125762|NCT01856569|O1|Outcome|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
125763|NCT01856569|O1|Outcome|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
125764|NCT01856569|E1|Reported Event|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
125765|NCT01856530|B3|Baseline|Total|Total of all reporting groups
125766|NCT01856530|B2|Baseline|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
125767|NCT01856530|B1|Baseline|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
125768|NCT01856530|P2|Participant Flow|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
125769|NCT01856530|P1|Participant Flow|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
125770|NCT01856530|O2|Outcome|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
125771|NCT01856530|O1|Outcome|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
125772|NCT01856530|O2|Outcome|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
125779|NCT01856530|O1|Outcome|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
125780|NCT01856530|O2|Outcome|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
125781|NCT01856530|O1|Outcome|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
125782|NCT01856530|E2|Reported Event|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
125783|NCT01856530|E1|Reported Event|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
125784|NCT01856491|B1|Baseline|RELIANCE 4-FRONT™ Passive Fixation|"Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead~RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism."
125785|NCT01856491|P1|Participant Flow|RELIANCE 4-FRONT™ Passive Fixation|"Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead~RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism."
125786|NCT01856491|O1|Outcome|RELIANCE 4-FRONT™ Passive Fixation|"Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead~RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism."
125787|NCT01856491|O1|Outcome|RELIANCE 4-FRONT™ Passive Fixation|"Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead~RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism."
125788|NCT01856491|O1|Outcome|RELIANCE 4-FRONT™ Passive Fixation|"Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead~RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism."
125789|NCT01856491|O1|Outcome|RELIANCE 4-FRONT™ Passive Fixation|"Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead~RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism."
125790|NCT01856491|E1|Reported Event|RELIANCE 4-FRONT™ Passive Fixation|"Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead~RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism."
125791|NCT01856361|B3|Baseline|Total|Total of all reporting groups
125792|NCT01856361|B2|Baseline|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.~Placebo: Placebo pill that will match the treatment pill"
125793|NCT01856361|B1|Baseline|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.~Ramipril: Angiotensin Converting Enzyme Inhibitor"
125794|NCT01856361|P2|Participant Flow|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.~Placebo: Placebo pill that will match the treatment pill"
125795|NCT01856361|P1|Participant Flow|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.~Ramipril: Angiotensin Converting Enzyme Inhibitor"
125796|NCT01856361|O2|Outcome|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.~Placebo: Placebo pill that will match the treatment pill"
125797|NCT01856361|O1|Outcome|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.~Ramipril: Angiotensin Converting Enzyme Inhibitor"
125798|NCT01856361|O2|Outcome|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.~Placebo: Placebo pill that will match the treatment pill"
125799|NCT01856361|O1|Outcome|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.~Ramipril: Angiotensin Converting Enzyme Inhibitor"
125800|NCT01856361|O2|Outcome|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.~Placebo: Placebo pill that will match the treatment pill"
125801|NCT01856361|O1|Outcome|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.~Ramipril: Angiotensin Converting Enzyme Inhibitor"
125802|NCT01856361|O2|Outcome|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.~Placebo: Placebo pill that will match the treatment pill"
125803|NCT01856361|O1|Outcome|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.~Ramipril: Angiotensin Converting Enzyme Inhibitor"
125804|NCT01856361|O2|Outcome|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.~Placebo: Placebo pill that will match the treatment pill"
125805|NCT01856361|O1|Outcome|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.~Ramipril: Angiotensin Converting Enzyme Inhibitor"
144018|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
125806|NCT01856361|E2|Reported Event|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.~Placebo: Placebo pill that will match the treatment pill"
125807|NCT01856361|E1|Reported Event|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.~Ramipril: Angiotensin Converting Enzyme Inhibitor"
125808|NCT01856322|B4|Baseline|Total|Total of all reporting groups
125809|NCT01856322|B3|Baseline|Normal Volunteers (or Control Group)|Normal volunteers (or control group) enrolled with the only purpose to validate assays and the shipping method.
125810|NCT01856322|B2|Baseline|Placebo|"one tablet twice daily~Placebo: One tablet twice daily"
125811|NCT01856322|B1|Baseline|Sulindac|"one tablet twice daily~Sulindac: one tablet twice daily"
125812|NCT01856322|P3|Participant Flow|Normal Volunteers (or Control Group)|Normal volunteers (or control group) enrolled with the only purpose to validate assays and the shipping method.
125813|NCT01856322|P2|Participant Flow|Placebo|"one tablet twice daily~Placebo: One tablet twice daily"
125814|NCT01856322|P1|Participant Flow|Sulindac|"one tablet twice daily~Sulindac: one tablet twice daily"
125815|NCT01856322|O2|Outcome|Placebo|"one tablet twice daily~Placebo: One tablet twice daily"
125816|NCT01856322|O1|Outcome|Sulindac|"one tablet twice daily~Sulindac: one tablet twice daily"
125817|NCT01856322|E3|Reported Event|Normal Volunteers (or Control Group)|Normal volunteers (or control group) enrolled with the only purpose to validate assays and the shipping method.
125818|NCT01856322|E2|Reported Event|Placebo|"one tablet twice daily~Placebo: One tablet twice daily"
125819|NCT01856322|E1|Reported Event|Sulindac|"one tablet twice daily~Sulindac: one tablet twice daily"
125820|NCT01856270|B3|Baseline|Total|Total of all reporting groups
125821|NCT01856270|B2|Baseline|Amitriptyline Delayed|"The Delayed group will start the study drug at the Day 30 visit on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.~Amitriptyline: Participants with headache will be enrolled within the first 12 weeks post injury and will be randomly assigned to 2 groups. Group 1 will be assessed within 3 months of injury (baseline, Day 0) (when they will receive their initial ramp-up dosage containers), Day 30 and 60 (to monitor compliance/distribute study drug), and for final outcome on Day 90. Group 2 will be assessed within 3 months of injury (baseline, Day 0) but will not receive medication until their Day 30 visit. Those in group 2 who report headache at Day 30 will receive initial dosage container and then reassessed at Day 60 (to monitor compliance and distribute study drug) and Day 90 (final outcome)."
125822|NCT01856270|B1|Baseline|Amitriptyline Immediate|"The Immediate group will begin study drug immediately after enrollment. Immediate Drug participants will be started on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.~Amitriptyline: Participants with headache will be enrolled within the first 12 weeks post injury and will be randomly assigned to 2 groups. Group 1 will be assessed within 3 months of injury (baseline, Day 0) (when they will receive their initial ramp-up dosage containers), Day 30 and 60 (to monitor compliance/distribute study drug), and for final outcome on Day 90. Group 2 will be assessed within 3 months of injury (baseline, Day 0) but will not receive medication until Day 30 visit. Those in group 2 who report headache at Day 30 will receive initial dosage container and reassessed at Day 60 (to monitor compliance and distribute study drug) and Day 90 (final outcome)."
125823|NCT01856270|P2|Participant Flow|Amitriptyline Delayed|"The Delayed group will start the study drug at the Day 30 visit on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.~Amitriptyline: Participants with headache will be enrolled within the first 12 weeks after injury and will be randomly assigned to 2 groups. Group 1 will be assessed within 3 months of injury (baseline, Day 0) (when they will receive their initial ramp-up dosage containers), Day 30 and Day 60 (to monitor compliance and distribute study drug), and for final outcome on Day 90. Group 2 will be assessed within 3 months of injury (baseline, Day 0) but will not receive medication until their Day 30 visit. Those in group 2 who report headache at Day 30 will receive their initial dosage container and will then be reassessed at Day 60 (to monitor compliance and distribute study drug) and Day 90 (final outcome)."
125824|NCT01856270|P1|Participant Flow|Amitriptyline Immediate|"The Immediate group will begin study drug immediately after enrollment. Immediate Drug participants will be started on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.~Amitriptyline: Participants with headache will be enrolled within the first 12 weeks after injury and will be randomly assigned to 2 groups. Group 1 will be assessed within 3 months of injury (baseline, Day 0) (when receiving initial ramp-up dosage containers), Day 30 and 60 (to monitor compliance and distribute study drug), and for final outcome on Day 90. Group 2 will be assessed within 3 months of injury (baseline, Day 0) but will not receive medication until Day 30 visit. Those in group 2 who report headache at Day 30 will receive their initial dosage container and will then be reassessed at Day 60 (to monitor compliance/distribute study drug) and Day 90 (final outcome)."
125825|NCT01856270|O2|Outcome|Amitriptyline Delayed|The Amitriptyline Delayed group will start the study drug at the Day 30 visit on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
125826|NCT01856270|O1|Outcome|Amitriptyline Immediate|The Amitriptyline Immediate group will begin study drug immediately after enrollment. Immediate Drug participants will be started on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
125827|NCT01856270|O2|Outcome|Amitriptyline Delayed|The Amitriptyline Delayed group will start the study drug at the Day 30 visit on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
125828|NCT01856270|O1|Outcome|Amitriptyline Immediate|The Amitriptyline Immediate group will begin study drug immediately after enrollment. Immediate Drug participants will be started on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
126043|NCT01855945|B6|Baseline|A/H3N2C : 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
125829|NCT01856270|O2|Outcome|Amitriptyline Delayed|The Amitriptyline Delayed group will start the study drug at the Day 30 visit on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
125830|NCT01856270|O1|Outcome|Amitriptyline Immediate|The Amitriptyline Immediate group will begin study drug immediately after enrollment. Immediate Drug participants will be started on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
125831|NCT01856270|O2|Outcome|Amitriptyline Delayed|The Amitriptyline Delayed group will start the study drug at the Day 30 visit on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
125832|NCT01856270|O1|Outcome|Amitriptyline Immediate|The Amitriptyline Immediate group will begin study drug immediately after enrollment. Immediate Drug participants will be started on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
125833|NCT01856270|O2|Outcome|Amitriptyline Delayed|The Amitriptyline Delayed group will start the study drug at the Day 30 visit on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
125834|NCT01856270|O1|Outcome|Amitriptyline Immediate|The Amitriptyline Immediate group will begin study drug immediately after enrollment. Immediate Drug participants will be started on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
125835|NCT01856270|O2|Outcome|Amitriptyline Delayed|The Amitriptyline Delayed group will start the study drug at the Day 30 visit on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
125836|NCT01856270|O1|Outcome|Amitriptyline Immediate|The Amitriptyline Immediate group will begin study drug immediately after enrollment. Immediate Drug participants will be started on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
125837|NCT01856270|O2|Outcome|Amitriptyline Delayed|The Amitriptyline Delayed group will start the study drug at the Day 30 visit on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
125838|NCT01856270|O1|Outcome|Amitriptyline Immediate|The Amitriptyline Immediate group will begin study drug immediately after enrollment. Immediate Drug participants will be started on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
125839|NCT01856270|O1|Outcome|Amitriptyline Study|Individuals enrolled into the current study.
125840|NCT01856270|O1|Outcome|Amitriptyline Sample|Individuals enrolled into the study and who have completed headache diaries through 3 months post injury.
125841|NCT01856270|E2|Reported Event|Amitriptyline Delayed|The Delayed group will start the study drug at the Day 30 visit on one 10 mg capsule each evening to assess whether there is any cognitive impact of the medication (comparing to those who started immediately after enrollment. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
125842|NCT01856270|E1|Reported Event|Amitriptyline Immediate|The Immediate group will begin study drug immediately after enrollment. Immediate Drug participants will be started on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
125843|NCT01856257|B4|Baseline|Total|Total of all reporting groups
125844|NCT01856257|B3|Baseline|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125845|NCT01856257|B2|Baseline|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125846|NCT01856257|B1|Baseline|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
125847|NCT01856257|P4|Participant Flow|Enrolled, Not Randomized|Subjects who signed informed consent and were thus enrolled, but were not randomized to study treatment.
125964|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
126044|NCT01855945|B5|Baseline|A/H3N2C + MF59 : 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
125848|NCT01856257|P3|Participant Flow|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125849|NCT01856257|P2|Participant Flow|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125850|NCT01856257|P1|Participant Flow|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
125851|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125852|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125853|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
125854|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125855|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125856|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
126437|NCT01854658|E3|Reported Event|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
125857|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125858|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125859|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
125860|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125861|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125862|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
125863|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125864|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125865|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
126438|NCT01854658|E2|Reported Event|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
125866|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125867|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125868|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
125869|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125870|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125871|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
125872|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125873|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125874|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
126439|NCT01854658|E1|Reported Event|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
125875|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125876|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125877|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
125878|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125879|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125880|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
125881|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125882|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125883|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
126440|NCT01854645|B6|Baseline|Total|Total of all reporting groups
125884|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125885|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125886|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
125887|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125888|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125889|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
125890|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125891|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125892|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
126441|NCT01854645|B5|Baseline|Placebo|Placebo MDI
125893|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125894|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125895|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
125896|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125897|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125898|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
125899|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125900|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125901|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
126442|NCT01854645|B4|Baseline|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
125902|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125903|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125904|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
125905|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125906|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125907|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
125908|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125909|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125910|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
126443|NCT01854645|B3|Baseline|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
125911|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125912|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125913|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
125914|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125915|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125916|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
125917|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125918|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125919|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
126444|NCT01854645|B2|Baseline|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
125920|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125921|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125922|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
125923|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125924|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125925|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
125926|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125927|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125928|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
126445|NCT01854645|B1|Baseline|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
125929|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125930|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125931|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
125932|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125933|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125934|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
125935|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125936|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125937|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
126446|NCT01854645|P5|Participant Flow|Placebo|Placebo MDI
125938|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125939|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125940|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
125941|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125942|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125943|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
125944|NCT01856257|E4|Reported Event|Enrolled, Not Randomized|Subjects who signed informed consent and were thus enrolled, but were not randomized to study treatment.
125945|NCT01856257|E3|Reported Event|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.~The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
125946|NCT01856257|E2|Reported Event|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
125965|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
126045|NCT01855945|B4|Baseline|A/H3N2C + 1/2 MF59 : 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
125947|NCT01856257|E1|Reported Event|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:~Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.~Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.~Maintenance:~Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.~The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
125948|NCT01856218|B1|Baseline|UX003|"During the initial 14-week treatment period of the study, participants received 2 mg/kg UX003 QOW for 12 weeks. At Week 14, participants continued on UX003 therapy and began a forced dose titration period for an additional 24 weeks at the dose sequence of 1, 4, and 2 mg/kg UX003 QOW as follows: 1 mg/kg UX003 for 8 weeks beginning on Week 14; then 4 mg/kg UX003 for 8 weeks beginning on Week 22; then 2 mg/kg UX003 for 8 weeks beginning on Week 30. Following the 24 week forced dose titration period, participants who continued on treatment (continuation period) received 2 mg/kg UX003 QOW beginning at Week 38 for up to an additional 36 weeks.~After the first phase of the study, participants who elected to continue drug treatment were transitioned to the long-term extension phase, where they were treated with UX003 at 4 mg/kg beginning at Week 74, for up to an additional 168 weeks."
125949|NCT01856218|P1|Participant Flow|UX003|"During the initial 14-week treatment period of the study, participants received 2 mg/kg UX003 every other week (QOW) for 12 weeks. At Week 14, participants continued on UX003 therapy and began a forced dose titration period for an additional 24 weeks at the dose sequence of 1, 4, and 2 mg/kg UX003 QOW as follows: 1 mg/kg UX003 for 8 weeks beginning on Week 14; then 4 mg/kg UX003 for 8 weeks beginning on Week 22; then 2 mg/kg UX003 for 8 weeks beginning on Week 30. Following the 24 week forced dose titration period, participants who continued on treatment (continuation period) received 2 mg/kg UX003 QOW beginning at Week 38 for up to an additional 36 weeks.~After the first phase of the study, participants who elected to continue drug treatment were transitioned to the long-term extension phase, where they were treated with UX003 at 4 mg/kg beginning at Week 74, for up to an additional 168 weeks."
125950|NCT01856218|O1|Outcome|UX003|"During the initial 14-week treatment period of the study, participants received 2 mg/kg UX003 QOW for 12 weeks. At Week 14, participants continued on UX003 therapy and began a forced dose titration period for an additional 24 weeks at the dose sequence of 1, 4, and 2 mg/kg UX003 QOW as follows: 1 mg/kg UX003 for 8 weeks beginning on Week 14; then 4 mg/kg UX003 for 8 weeks beginning on Week 22; then 2 mg/kg UX003 for 8 weeks beginning on Week 30. Following the 24 week forced dose titration period, participants who continued on treatment (continuation period) received 2 mg/kg UX003 QOW beginning at Week 38 for up to an additional 36 weeks.~After the first phase of the study, participants who elected to continue drug treatment were transitioned to the long-term extension phase, where they were treated with UX003 at 4 mg/kg beginning at Week 74, for up to an additional 168 weeks."
125951|NCT01856218|O1|Outcome|UX003|"During the initial 14-week treatment period of the study, participants received 2 mg/kg UX003 QOW for 12 weeks. At Week 14, participants continued on UX003 therapy and began a forced dose titration period for an additional 24 weeks at the dose sequence of 1, 4, and 2 mg/kg UX003 QOW as follows: 1 mg/kg UX003 for 8 weeks beginning on Week 14; then 4 mg/kg UX003 for 8 weeks beginning on Week 22; then 2 mg/kg UX003 for 8 weeks beginning on Week 30. Following the 24 week forced dose titration period, participants who continued on treatment (continuation period) received 2 mg/kg UX003 QOW beginning at Week 38 for up to an additional 36 weeks.~After the first phase of the study, participants who elected to continue drug treatment were transitioned to the long-term extension phase, where they were treated with UX003 at 4 mg/kg beginning at Week 74, for up to an additional 168 weeks."
125952|NCT01856218|O1|Outcome|UX003|"During the initial 14-week treatment period of the study, participants received 2 mg/kg UX003 QOW for 12 weeks. At Week 14, participants continued on UX003 therapy and began a forced dose titration period for an additional 24 weeks at the dose sequence of 1, 4, and 2 mg/kg UX003 QOW as follows: 1 mg/kg UX003 for 8 weeks beginning on Week 14; then 4 mg/kg UX003 for 8 weeks beginning on Week 22; then 2 mg/kg UX003 for 8 weeks beginning on Week 30. Following the 24 week forced dose titration period, participants who continued on treatment (continuation period) received 2 mg/kg UX003 QOW beginning at Week 38 for up to an additional 36 weeks.~After the first phase of the study, participants who elected to continue drug treatment were transitioned to the long-term extension phase, where they were treated with UX003 at 4 mg/kg beginning at Week 74, for up to an additional 168 weeks."
125953|NCT01856218|O1|Outcome|UX003|"During the initial 14-week treatment period of the study, participants received 2 mg/kg UX003 QOW for 12 weeks. At Week 14, participants continued on UX003 therapy and began a forced dose titration period for an additional 24 weeks at the dose sequence of 1, 4, and 2 mg/kg UX003 QOW as follows: 1 mg/kg UX003 for 8 weeks beginning on Week 14; then 4 mg/kg UX003 for 8 weeks beginning on Week 22; then 2 mg/kg UX003 for 8 weeks beginning on Week 30. Following the 24 week forced dose titration period, participants who continued on treatment (continuation period) received 2 mg/kg UX003 QOW beginning at Week 38 for up to an additional 36 weeks.~After the first phase of the study, participants who elected to continue drug treatment were transitioned to the long-term extension phase, where they were treated with UX003 at 4 mg/kg beginning at Week 74, for up to an additional 168 weeks."
125954|NCT01856218|O1|Outcome|UX003|"During the initial 14-week treatment period of the study, participants received 2 mg/kg UX003 QOW for 12 weeks. At Week 14, participants continued on UX003 therapy and began a forced dose titration period for an additional 24 weeks at the dose sequence of 1, 4, and 2 mg/kg UX003 QOW as follows: 1 mg/kg UX003 for 8 weeks beginning on Week 14; then 4 mg/kg UX003 for 8 weeks beginning on Week 22; then 2 mg/kg UX003 for 8 weeks beginning on Week 30. Following the 24 week forced dose titration period, participants who continued on treatment (continuation period) received 2 mg/kg UX003 QOW beginning at Week 38 for up to an additional 36 weeks.~After the first phase of the study, participants who elected to continue drug treatment were transitioned to the long-term extension phase, where they were treated with UX003 at 4 mg/kg beginning at Week 74, for up to an additional 168 weeks."
125966|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
144019|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
125955|NCT01856218|O1|Outcome|UX003|"During the initial 14-week treatment period of the study, participants received 2 mg/kg UX003 QOW for 12 weeks. At Week 14, participants continued on UX003 therapy and began a forced dose titration period for an additional 24 weeks at the dose sequence of 1, 4, and 2 mg/kg UX003 QOW as follows: 1 mg/kg UX003 for 8 weeks beginning on Week 14; then 4 mg/kg UX003 for 8 weeks beginning on Week 22; then 2 mg/kg UX003 for 8 weeks beginning on Week 30. Following the 24 week forced dose titration period, participants who continued on treatment (continuation period) received 2 mg/kg UX003 QOW beginning at Week 38 for up to an additional 36 weeks.~After the first phase of the study, participants who elected to continue drug treatment were transitioned to the long-term extension phase, where they were treated with UX003 at 4 mg/kg beginning at Week 74, for up to an additional 168 weeks."
125956|NCT01856218|O1|Outcome|UX003|"During the initial 14-week treatment period of the study, participants received 2 mg/kg UX003 QOW for 12 weeks. At Week 14, participants continued on UX003 therapy and began a forced dose titration period for an additional 24 weeks at the dose sequence of 1, 4, and 2 mg/kg UX003 QOW as follows: 1 mg/kg UX003 for 8 weeks beginning on Week 14; then 4 mg/kg UX003 for 8 weeks beginning on Week 22; then 2 mg/kg UX003 for 8 weeks beginning on Week 30. Following the 24 week forced dose titration period, participants who continued on treatment (continuation period) received 2 mg/kg UX003 QOW beginning at Week 38 for up to an additional 36 weeks.~After the first phase of the study, participants who elected to continue drug treatment were transitioned to the long-term extension phase, where they were treated with UX003 at 4 mg/kg beginning at Week 74, for up to an additional 168 weeks."
125957|NCT01856218|O1|Outcome|UX003|"During the initial 14-week treatment period of the study, participants received 2 mg/kg UX003 QOW for 12 weeks. At Week 14, participants continued on UX003 therapy and began a forced dose titration period for an additional 24 weeks at the dose sequence of 1, 4, and 2 mg/kg UX003 QOW as follows: 1 mg/kg UX003 for 8 weeks beginning on Week 14; then 4 mg/kg UX003 for 8 weeks beginning on Week 22; then 2 mg/kg UX003 for 8 weeks beginning on Week 30. Following the 24 week forced dose titration period, participants who continued on treatment (continuation period) received 2 mg/kg UX003 QOW beginning at Week 38 for up to an additional 36 weeks.~After the first phase of the study, participants who elected to continue drug treatment were transitioned to the long-term extension phase, where they were treated with UX003 at 4 mg/kg beginning at Week 74, for up to an additional 168 weeks."
125958|NCT01856218|O1|Outcome|UX003|"During the initial 14-week treatment period of the study, participants received 2 mg/kg UX003 QOW for 12 weeks. At Week 14, participants continued on UX003 therapy and began a forced dose titration period for an additional 24 weeks at the dose sequence of 1, 4, and 2 mg/kg UX003 QOW as follows: 1 mg/kg UX003 for 8 weeks beginning on Week 14; then 4 mg/kg UX003 for 8 weeks beginning on Week 22; then 2 mg/kg UX003 for 8 weeks beginning on Week 30. Following the 24 week forced dose titration period, participants who continued on treatment (continuation period) received 2 mg/kg UX003 QOW beginning at Week 38 for up to an additional 36 weeks.~After the first phase of the study, participants who elected to continue drug treatment were transitioned to the long-term extension phase, where they were treated with UX003 at 4 mg/kg beginning at Week 74, for up to an additional 168 weeks."
125959|NCT01856218|O1|Outcome|UX003|"During the initial 14-week treatment period of the study, participants received 2 mg/kg UX003 QOW for 12 weeks. At Week 14, participants continued on UX003 therapy and began a forced dose titration period for an additional 24 weeks at the dose sequence of 1, 4, and 2 mg/kg UX003 QOW as follows: 1 mg/kg UX003 for 8 weeks beginning on Week 14; then 4 mg/kg UX003 for 8 weeks beginning on Week 22; then 2 mg/kg UX003 for 8 weeks beginning on Week 30. Following the 24 week forced dose titration period, participants who continued on treatment (continuation period) received 2 mg/kg UX003 QOW beginning at Week 38 for up to an additional 36 weeks.~After the first phase of the study, participants who elected to continue drug treatment were transitioned to the long-term extension phase, where they were treated with UX003 at 4 mg/kg beginning at Week 74, for up to an additional 168 weeks."
125960|NCT01856218|O1|Outcome|UX003|"During the initial 14-week treatment period of the study, participants received 2 mg/kg UX003 QOW for 12 weeks. At Week 14, participants continued on UX003 therapy and began a forced dose titration period for an additional 24 weeks at the dose sequence of 1, 4, and 2 mg/kg UX003 QOW as follows: 1 mg/kg UX003 for 8 weeks beginning on Week 14; then 4 mg/kg UX003 for 8 weeks beginning on Week 22; then 2 mg/kg UX003 for 8 weeks beginning on Week 30. Following the 24 week forced dose titration period, participants who continued on treatment (continuation period) received 2 mg/kg UX003 QOW beginning at Week 38 for up to an additional 36 weeks.~After the first phase of the study, participants who elected to continue drug treatment were transitioned to the long-term extension phase, where they were treated with UX003 at 4 mg/kg beginning at Week 74, for up to an additional 168 weeks."
125961|NCT01856218|E1|Reported Event|UX003|"During the initial 14-week treatment period of the study, participants received 2 mg/kg UX003 QOW for 12 weeks. At Week 14, participants continued on UX003 therapy and began a forced dose titration period for an additional 24 weeks at the dose sequence of 1, 4, and 2 mg/kg UX003 QOW as follows: 1 mg/kg UX003 for 8 weeks beginning on Week 14; then 4 mg/kg UX003 for 8 weeks beginning on Week 22; then 2 mg/kg UX003 for 8 weeks beginning on Week 30. Following the 24 week forced dose titration period, participants who continued on treatment (continuation period) received 2 mg/kg UX003 QOW beginning at Week 38 for up to an additional 36 weeks.~After the first phase of the study, participants who elected to continue drug treatment were transitioned to the long-term extension phase, where they were treated with UX003 at 4 mg/kg beginning at Week 74, for up to an additional 168 weeks."
125962|NCT01855997|B1|Baseline|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125963|NCT01855997|P1|Participant Flow|Adult Participants Treated With Peg-IFN|Adult participants with hepatitis B envelope antigen (HBeAg)-positive or -negative chronic hepatitis B (CHB) infection who completed greater than or equal to (≥) 24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
126038|NCT01855945|B11|Baseline|A/H3N2C + MF59 : ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126447|NCT01854645|P4|Participant Flow|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
125967|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125968|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125969|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125970|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125971|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125972|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125973|NCT01855997|O1|Outcome|HBeAg-Negative Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125974|NCT01855997|O1|Outcome|HBeAg-Negative CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125975|NCT01855997|O1|Outcome|HBeAg-Negative Participants Treated With Peg-IFN|Adult participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125976|NCT01855997|O1|Outcome|HBeAg-Positive Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125977|NCT01855997|O1|Outcome|HBeAg-Positive CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125978|NCT01855997|O1|Outcome|HBeAg-Positive Participants Treated With Peg-IFN|Adult participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125979|NCT01855997|O1|Outcome|HBeAg-Positive Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125980|NCT01855997|O1|Outcome|HBeAg-Positive CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125981|NCT01855997|O1|Outcome|HBeAg-Positive Participants Treated With Peg-IFN|Adult participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125982|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
126039|NCT01855945|B10|Baseline|A/H3N2C + 1/2 MF59 : ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126448|NCT01854645|P3|Participant Flow|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
125983|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125984|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125985|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125986|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125987|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125988|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125989|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125990|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125991|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125992|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125993|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125994|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125995|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125996|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125997|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
125998|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
126040|NCT01855945|B9|Baseline|A/H3N2C : 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
144020|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
125999|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
126000|NCT01855997|O1|Outcome|HBeAg-Negative Participants Treated With Peg-IFN|Adult participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
126001|NCT01855997|O1|Outcome|HBeAg-Negative Participants Treated With Peg-IFN|Adult participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
126002|NCT01855997|O1|Outcome|HBeAg-Negative CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
126003|NCT01855997|O1|Outcome|HBeAg-Negative CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
126004|NCT01855997|O1|Outcome|HBeAg-Negative Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
126005|NCT01855997|O1|Outcome|HBeAg-Negative Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
126006|NCT01855997|O1|Outcome|HBeAg-Positive Participants Treated With Peg-IFN|Adult participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
126007|NCT01855997|O1|Outcome|HBeAg-Positive Participants Treated With Peg-IFN|Adult participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
126008|NCT01855997|O1|Outcome|HBeAg-Positive CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
126009|NCT01855997|O1|Outcome|HBeAg-Positive CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
126010|NCT01855997|O1|Outcome|HBeAg-Positive Participants Treated With Peg-IFN|Adult participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
126011|NCT01855997|O1|Outcome|HBeAg-Positive Participants Treated With Peg-IFN|Adult participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
126012|NCT01855997|O1|Outcome|HBeAg-Positive CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
126013|NCT01855997|O1|Outcome|HBeAg-Positive CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
126014|NCT01855997|E1|Reported Event|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection, and who had completed at least 24 weeks of Peg-IFN alfa-2a with/without nucleoside analogue therapy and at least 24 weeks of follow-up, were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
126015|NCT01855958|B3|Baseline|Total|Total of all reporting groups
126041|NCT01855945|B8|Baseline|A/H3N2C + MF59 : 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126449|NCT01854645|P2|Participant Flow|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
126016|NCT01855958|B2|Baseline|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
126017|NCT01855958|B1|Baseline|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
126018|NCT01855958|P2|Participant Flow|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
126019|NCT01855958|P1|Participant Flow|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
126020|NCT01855958|O2|Outcome|Placebo-sham|"The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.~Placebo-sham: Electro acupuncture with rubber electrodes, without current passing."
126021|NCT01855958|O1|Outcome|DIMST|"The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterior; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.~DIMST: The investigators used electro acupuncture of 2 Hz during 30 minutes."
126022|NCT01855958|O2|Outcome|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
126023|NCT01855958|O1|Outcome|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
126024|NCT01855958|O2|Outcome|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
126025|NCT01855958|O1|Outcome|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
126042|NCT01855945|B7|Baseline|A/H3N2C + 1/2 MF59 : 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126450|NCT01854645|P1|Participant Flow|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
126026|NCT01855958|O2|Outcome|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
126027|NCT01855958|O1|Outcome|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
126028|NCT01855958|O2|Outcome|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
126029|NCT01855958|O1|Outcome|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
126030|NCT01855958|O2|Outcome|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
126031|NCT01855958|O1|Outcome|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
126032|NCT01855958|O2|Outcome|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
126033|NCT01855958|O1|Outcome|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
126034|NCT01855958|E2|Reported Event|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
126035|NCT01855958|E1|Reported Event|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
126036|NCT01855945|B13|Baseline|Total|Total of all reporting groups
126037|NCT01855945|B12|Baseline|A/H3N2C : ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126451|NCT01854645|O5|Outcome|Placebo|Placebo MDI
126452|NCT01854645|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
126046|NCT01855945|B3|Baseline|A/H3N2C : 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126047|NCT01855945|B2|Baseline|A/H3N2C + MF59 : 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126048|NCT01855945|B1|Baseline|A/H3N2C + 1/2 MF59 : 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126049|NCT01855945|P12|Participant Flow|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126050|NCT01855945|P11|Participant Flow|A/H3N2C + MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126051|NCT01855945|P10|Participant Flow|A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126052|NCT01855945|P9|Participant Flow|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126053|NCT01855945|P8|Participant Flow|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126054|NCT01855945|P7|Participant Flow|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
126055|NCT01855945|P6|Participant Flow|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126056|NCT01855945|P5|Participant Flow|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126057|NCT01855945|P4|Participant Flow|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
126058|NCT01855945|P3|Participant Flow|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126059|NCT01855945|P2|Participant Flow|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126060|NCT01855945|P1|Participant Flow|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126061|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126062|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126063|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126064|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126065|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126066|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126067|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126068|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126069|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126070|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126071|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126072|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126073|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126074|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126075|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126076|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126077|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126078|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126079|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126080|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126081|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126082|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126083|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126084|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126085|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126086|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126087|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
126088|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <61 YEARS|Subjects 18 to <61years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126089|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126090|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126091|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126092|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126093|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126094|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126095|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126096|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126097|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥61 YEARS|Subjects ≥61 years old Received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126098|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old Received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126099|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old Received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126100|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old Received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126101|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old Received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126102|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old Received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126103|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126104|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126105|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126106|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126107|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
144021|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
126108|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126109|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126110|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126111|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126112|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126113|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126114|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126115|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126116|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126117|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126118|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126119|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126120|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126121|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126122|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126123|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126124|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126125|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126126|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126127|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126128|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126129|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126130|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126131|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126132|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126133|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126134|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126135|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126136|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126137|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126138|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126139|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126140|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126141|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126142|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126143|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126144|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126145|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126146|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126147|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126148|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126149|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126150|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126151|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126152|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126153|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126154|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126155|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126156|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126157|NCT01855945|O12|Outcome|A/H3N2C Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126158|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126159|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
126160|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126161|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126162|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
126163|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126164|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126165|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
126166|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126167|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126168|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
126169|NCT01855945|O3|Outcome|A/H3N2C - Age Group: ≥65 YEARS|Subjects ≥65 years old Received two injections of cell-culture derived H3N2c vaccine, each dose containing 15 µg H3N2c antigen.
126453|NCT01854645|O3|Outcome|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
126170|NCT01855945|O2|Outcome|A/H3N2C + MF59 - Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg antigen adjuvanted with full dose MF59.
126171|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 - Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126172|NCT01855945|O3|Outcome|A/H3N2C - Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old Received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126173|NCT01855945|O2|Outcome|A/H3N2C + MF59 - Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126174|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 - Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
126175|NCT01855945|O3|Outcome|A/H3N2C - Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126176|NCT01855945|O2|Outcome|A/H3N2C + MF59 - Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126177|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 - Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59 Subjects 3 to <9 years.
126178|NCT01855945|O3|Outcome|A/H3N2C - Age Group: 3 TO <9 YEARS|Subjects, 3 to < 9 years old, received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126179|NCT01855945|O2|Outcome|A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS|Subjects, 3 to < 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg antigen adjuvanted with full dose MF59.
126180|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS|Subjects, 3 to < 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
126181|NCT01855945|E12|Reported Event|A/H3N2C Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126182|NCT01855945|E11|Reported Event|A/H3N2C + MF59 Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126183|NCT01855945|E10|Reported Event|A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
126184|NCT01855945|E9|Reported Event|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126185|NCT01855945|E8|Reported Event|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126186|NCT01855945|E7|Reported Event|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
126187|NCT01855945|E6|Reported Event|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126188|NCT01855945|E5|Reported Event|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126189|NCT01855945|E4|Reported Event|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
126190|NCT01855945|E3|Reported Event|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
126191|NCT01855945|E2|Reported Event|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
126192|NCT01855945|E1|Reported Event|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
126193|NCT01855919|B3|Baseline|Total|Total of all reporting groups
126194|NCT01855919|B2|Baseline|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
126195|NCT01855919|B1|Baseline|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
126196|NCT01855919|P2|Participant Flow|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
126197|NCT01855919|P1|Participant Flow|Duloxetine|Duloxetine 20 milligram (mg) during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
126198|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
126199|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
126200|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
126201|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
126202|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
126203|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
126204|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
126205|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
126206|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
126207|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during the last week.
126208|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
126209|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
126210|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
126211|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
126212|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
126213|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
126214|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
126215|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
126216|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
126217|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
126218|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
126219|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
126220|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
126221|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
126222|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
126223|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
126224|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
126225|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
126226|NCT01855919|E2|Reported Event|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
126227|NCT01855919|E1|Reported Event|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
126228|NCT01855789|B1|Baseline|Overall Study Population|All enrolled participants received TCZ at a dose of 162 mg via SC injection qw (if body weight was >/=100 kg) or q2w (if body weight was <100 kg) along with MTX at a stable dose (15 mg to 25 mg per week) in an open-label manner orally for 24 weeks. Participants, who achieved a DAS28 score </=3.2 at Week 24, were randomized and received double-blind treatment according to the arm in which they were randomized (TCZ + MTX or TCZ + PBO) up to Week 52. Participants who did not achieve a DAS28 score </=3.2 at Week 24 continued the same treatment in a non-randomized open-label manner up to Week 52.
126229|NCT01855789|P4|Participant Flow|Period 2: Non-Randomized Participants (TCZ + MTX)|Participants, who completed the initial 24-week treatment with TCZ + MTX and did not achieve a DAS28 score </=3.2 at Week 24, continued receiving TCZ at a dose of 162 mg via SC injection qw along with MTX in open label manner orally up to Week 52.
126230|NCT01855789|P3|Participant Flow|Period 2: Randomized Participants (TCZ + PBO)|Participants, who completed the initial 24-week treatment with TCZ + MTX and achieved a DAS28 score </=3.2 at Week 24, were randomized and received TCZ at a dose of 162 mg via SC injection qw or q2w along with MTX matched placebo (PBO) orally up to Week 52.
126231|NCT01855789|P2|Participant Flow|Period 2: Randomized Participants (TCZ + MTX)|Participants, who completed the initial 24-week treatment with TCZ + MTX and achieved a DAS28 score </=3.2 at Week 24, were randomized and received TCZ at a dose of 162 mg via SC injection qw or q2w along with MTX at a stable dose orally up to Week 52.
126250|NCT01855789|O2|Outcome|Period 2: Randomized Participants (TCZ + PBO)|Participants, who completed the initial 24-week treatment with TCZ + MTX and achieved a DAS28 score </=3.2 at Week 24, were randomized and received TCZ at a dose of 162 mg via SC injection qw or q2w along with MTX matched placebo (PBO) orally up to Week 52.
126319|NCT01854905|O1|Outcome|Patients Attending Consultation for LASIK|Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
126232|NCT01855789|P1|Participant Flow|Period 1: All Participants (TCZ + MTX)|All enrolled participants received tocilizumab (TCZ) at a dose of 162 milligrams (mg) via subcutaneous (SC) injection weekly (qw; if body weight was greater than or equal to [>/=] 100 kilograms [kg]) or every 2 weeks (q2w; if body weight was less than [<] 100 kg) along with methotrexate (MTX) at a stable dose (15 mg to 25 mg per week) in an open-label manner orally for 24 weeks. Participants, who achieved a disease activity score based on 28 joints (DAS28) less than or equal to (</=) 3.2 at Week 24, were randomized and received double-blind treatment according to the arm in which they were randomized (TCZ + MTX or TCZ + PBO [placebo]) up to Week 52. Participants who did not achieve a DAS28 score </=3.2 at Week 24 continued the same treatment in a non-randomized open-label manner up to Week 52.
126233|NCT01855789|O1|Outcome|Overall Study Population|All enrolled participants received TCZ at a dose of 162 mg via SC injection qw (if body weight was >/=100 kg) or q2w (if body weight was <100 kg) along with MTX at a stable dose (15 mg to 25 mg per week) in an open-label manner orally for 24 weeks. Participants, who achieved a DAS28 score </=3.2 at Week 24, were randomized and received double-blind treatment according to the arm in which they were randomized (TCZ + MTX or TCZ + PBO) up to Week 52. Participants who did not achieve a DAS28 score </=3.2 at Week 24 continued the same treatment in a non-randomized open-label manner up to Week 52.
126234|NCT01855789|O1|Outcome|Overall Study Population|All enrolled participants received TCZ at a dose of 162 mg via SC injection qw (if body weight was >/=100 kg) or q2w (if body weight was <100 kg) along with MTX at a stable dose (15 mg to 25 mg per week) in an open-label manner orally for 24 weeks. Participants, who achieved a DAS28 score </=3.2 at Week 24, were randomized and received double-blind treatment according to the arm in which they were randomized (TCZ + MTX or TCZ + PBO) up to Week 52. Participants who did not achieve a DAS28 score </=3.2 at Week 24 continued the same treatment in a non-randomized open-label manner up to Week 52.
126235|NCT01855789|O1|Outcome|Overall Study Population|All enrolled participants received TCZ at a dose of 162 mg via SC injection qw (if body weight was >/=100 kg) or q2w (if body weight was <100 kg) along with MTX at a stable dose (15 mg to 25 mg per week) in an open-label manner orally for 24 weeks. Participants, who achieved a DAS28 score </=3.2 at Week 24, were randomized and received double-blind treatment according to the arm in which they were randomized (TCZ + MTX or TCZ + PBO) up to Week 52. Participants who did not achieve a DAS28 score </=3.2 at Week 24 continued the same treatment in a non-randomized open-label manner up to Week 52.
126236|NCT01855789|O2|Outcome|Period 2: Randomized Participants (TCZ + PBO)|Participants, who completed the initial 24-week treatment with TCZ + MTX and achieved a DAS28 score </=3.2 at Week 24, were randomized and received TCZ at a dose of 162 mg via SC injection qw or q2w along with MTX matched placebo (PBO) orally up to Week 52.
126237|NCT01855789|O1|Outcome|Period 2: Randomized Participants (TCZ + MTX)|Participants, who completed the initial 24-week treatment with TCZ + MTX and achieved a DAS28 score </=3.2 at Week 24, were randomized and received TCZ at a dose of 162 mg via SC injection qw or q2w along with MTX at a stable dose orally up to Week 52.
126238|NCT01855789|O2|Outcome|Period 2: Randomized Participants (TCZ + PBO)|Participants, who completed the initial 24-week treatment with TCZ + MTX and achieved a DAS28 score </=3.2 at Week 24, were randomized and received TCZ at a dose of 162 mg via SC injection qw or q2w along with MTX matched placebo (PBO) orally up to Week 52.
126239|NCT01855789|O1|Outcome|Period 2: Randomized Participants (TCZ + MTX)|Participants, who completed the initial 24-week treatment with TCZ + MTX and achieved a DAS28 score </=3.2 at Week 24, were randomized and received TCZ at a dose of 162 mg via SC injection qw or q2w along with MTX at a stable dose orally up to Week 52.
126240|NCT01855789|O2|Outcome|Period 2: Randomized Participants (TCZ + PBO)|Participants, who completed the initial 24-week treatment with TCZ + MTX and achieved a DAS28 score </=3.2 at Week 24, were randomized and received TCZ at a dose of 162 mg via SC injection qw or q2w along with MTX matched placebo (PBO) orally up to Week 52.
126241|NCT01855789|O1|Outcome|Period 2: Randomized Participants (TCZ + MTX)|Participants, who completed the initial 24-week treatment with TCZ + MTX and achieved a DAS28 score </=3.2 at Week 24, were randomized and received TCZ at a dose of 162 mg via SC injection qw or q2w along with MTX at a stable dose orally up to Week 52.
126242|NCT01855789|O2|Outcome|Period 2: Randomized Participants (TCZ + PBO)|Participants, who completed the initial 24-week treatment with TCZ + MTX and achieved a DAS28 score </=3.2 at Week 24, were randomized and received TCZ at a dose of 162 mg via SC injection qw or q2w along with MTX matched placebo (PBO) orally up to Week 52.
126243|NCT01855789|O1|Outcome|Period 2: Randomized Participants (TCZ + MTX)|Participants, who completed the initial 24-week treatment with TCZ + MTX and achieved a DAS28 score </=3.2 at Week 24, were randomized and received TCZ at a dose of 162 mg via SC injection qw or q2w along with MTX at a stable dose orally up to Week 52.
126244|NCT01855789|O2|Outcome|Period 2: Randomized Participants (TCZ + PBO)|Participants, who completed the initial 24-week treatment with TCZ + MTX and achieved a DAS28 score </=3.2 at Week 24, were randomized and received TCZ at a dose of 162 mg via SC injection qw or q2w along with MTX matched placebo (PBO) orally up to Week 52.
126245|NCT01855789|O1|Outcome|Period 2: Randomized Participants (TCZ + MTX)|Participants, who completed the initial 24-week treatment with TCZ + MTX and achieved a DAS28 score </=3.2 at Week 24, were randomized and received TCZ at a dose of 162 mg via SC injection qw or q2w along with MTX at a stable dose orally up to Week 52.
126246|NCT01855789|O2|Outcome|Period 2: Randomized Participants (TCZ + PBO)|Participants, who completed the initial 24-week treatment with TCZ + MTX and achieved a DAS28 score </=3.2 at Week 24, were randomized and received TCZ at a dose of 162 mg via SC injection qw or q2w along with MTX matched placebo (PBO) orally up to Week 52.
126247|NCT01855789|O1|Outcome|Period 2: Randomized Participants (TCZ + MTX)|Participants, who completed the initial 24-week treatment with TCZ + MTX and achieved a DAS28 score </=3.2 at Week 24, were randomized and received TCZ at a dose of 162 mg via SC injection qw or q2w along with MTX at a stable dose orally up to Week 52.
126248|NCT01855789|O2|Outcome|Period 2: Randomized Participants (TCZ + PBO)|Participants, who completed the initial 24-week treatment with TCZ + MTX and achieved a DAS28 score </=3.2 at Week 24, were randomized and received TCZ at a dose of 162 mg via SC injection qw or q2w along with MTX matched placebo (PBO) orally up to Week 52.
126249|NCT01855789|O1|Outcome|Period 2: Randomized Participants (TCZ + MTX)|Participants, who completed the initial 24-week treatment with TCZ + MTX and achieved a DAS28 score </=3.2 at Week 24, were randomized and received TCZ at a dose of 162 mg via SC injection qw or q2w along with MTX at a stable dose orally up to Week 52.
126251|NCT01855789|O1|Outcome|Period 2: Randomized Participants (TCZ + MTX)|Participants, who completed the initial 24-week treatment with TCZ + MTX and achieved a DAS28 score </=3.2 at Week 24, were randomized and received TCZ at a dose of 162 mg via SC injection qw or q2w along with MTX at a stable dose orally up to Week 52.
126252|NCT01855789|E1|Reported Event|Overall Study Population|All enrolled participants received TCZ at a dose of 162 mg via SC injection qw (if body weight was >/=100 kg) or q2w (if body weight was <100 kg) along with MTX at a stable dose (15 mg to 25 mg per week) in an open-label manner orally for 24 weeks. Participants, who achieved a DAS28 score </=3.2 at Week 24, were randomized and received double-blind treatment according to the arm in which they were randomized (TCZ + MTX or TCZ + PBO) up to Week 52. Participants who did not achieve a DAS28 score </=3.2 at Week 24 continued the same treatment in a non-randomized open-label manner up to Week 52.
126253|NCT01855074|B1|Baseline|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
126254|NCT01855074|P1|Participant Flow|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
126255|NCT01855074|O1|Outcome|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
126256|NCT01855074|O1|Outcome|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
126257|NCT01855074|O1|Outcome|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
126258|NCT01855074|O1|Outcome|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
126259|NCT01855074|O1|Outcome|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
126260|NCT01855074|O1|Outcome|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
126261|NCT01855074|E1|Reported Event|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
126262|NCT01854944|B4|Baseline|Total|Total of all reporting groups
126263|NCT01854944|B3|Baseline|Cohort 3 - Brexpiprazole 4 mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126264|NCT01854944|B2|Baseline|Cohort 2 - Brexpiprazole 1 mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
126265|NCT01854944|B1|Baseline|Cohort 1 - Brexpiprazole 4 mg|Participants in cohort 1 received 1-mg tablet of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126266|NCT01854944|P3|Participant Flow|Cohort 3 - Brexpiprazole 4 mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126267|NCT01854944|P2|Participant Flow|Cohort 2 - Brexpiprazole 1 mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
126268|NCT01854944|P1|Participant Flow|Cohort 1 - Brexpiprazole 4 mg|Participants in cohort 1 received 1 milligram (mg) tablet of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126269|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126270|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
126271|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126272|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126273|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
126274|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126275|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126276|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
126277|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126278|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126279|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
126280|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126281|NCT01854944|O3|Outcome|Cohort 3 - Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126282|NCT01854944|O2|Outcome|Cohort 2 - Brexpiprazole 1mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
126283|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126284|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126285|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
126286|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126287|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126288|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
126289|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126290|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126291|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
126292|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126293|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126294|NCT01854944|O2|Outcome|Cohort 2 - Brexpiprazole 1mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
126295|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126296|NCT01854944|O3|Outcome|Cohort 3 - Brexpiprazole 4mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126297|NCT01854944|O2|Outcome|Cohort 2 - Brexpiprazole 1mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
126298|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126299|NCT01854944|O3|Outcome|Cohort 3 - Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126300|NCT01854944|O2|Outcome|Cohort 2 - Brexpiprazole 1mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
126301|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4 mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126302|NCT01854944|O3|Outcome|Cohort 3 - Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126303|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
126304|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126305|NCT01854944|O3|Outcome|Cohort 3 - Brexpiprazole 4 mg|Participants in Cohort 3 received one 1- to 4-mg dose of brexpiprazole (at the investigator’s discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126306|NCT01854944|O2|Outcome|Cohort 2 - Brexpiprazole 1mg|Participants in Cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
126307|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in Cohort 1 received 1-mg tablet of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126308|NCT01854944|O1|Outcome|Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126309|NCT01854944|O2|Outcome|Brexpiprazole 4 mg|Participants received 1-mg brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126310|NCT01854944|O1|Outcome|Brexpiprazole 1mg|Participants received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
126311|NCT01854944|O1|Outcome|Brexpiprazole 4mg|Participants received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126312|NCT01854944|O2|Outcome|Brexpiprazole 4 mg|Participants received 1-mg brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126313|NCT01854944|O1|Outcome|Brexpiprazole 1mg|Participants received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
126314|NCT01854944|E3|Reported Event|Cohort 3 - Brexpiprazole 4 mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126315|NCT01854944|E2|Reported Event|Cohort 2 - Brexpiprazole 1 mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
126316|NCT01854944|E1|Reported Event|Cohort 1 - Brexpiprazole 4 mg|Participants in cohort 1 received one 1-mg of brexpiprazole once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
126317|NCT01854905|B1|Baseline|Patients Attending Consultation for LASIK|Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
126318|NCT01854905|P1|Participant Flow|Patients Attending Consultation for LASIK|Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
126320|NCT01854905|E1|Reported Event|Patients Attending Consultation for LASIK|Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
126321|NCT01854827|B1|Baseline|IVIG Active Treatment|Intravenous Immunoglobulin (IVIG) active treatment for infants with biliary atresia
126322|NCT01854827|P1|Participant Flow|IVIG Active Treatment|"Intravenous immunoglobulin (IVIG) 10% 1 gm/kg body weight/dose Day 3-5,30, 60 post HPE~Intravenous immunoglobulin (IVIG): All participants will receive the same dose of IVIG at the same intervals in an open-label fashion as long as the subject does not have any increased risk for toxicity for any IVIG infusion. IVIG will be initiated on day 3 (up to day 5) after HPE surgery (HPE is day 0) at a dose of 1 gm/kg body weight by slow intravenous infusion over at least 4 hours. The same dose (1 gm/kg) and duration of infusion will be repeated on day 30 and day 60 after HPE."
126323|NCT01854827|O1|Outcome|IVIG Active Treatment|Intravenous Immunoglobulin (IVIG) active treatment for infants with biliary atresia
126324|NCT01854827|O1|Outcome|IVIG Active Treatment|Intravenous Immunoglobulin (IVIG) active treatment for infants with biliary atresia
126325|NCT01854827|O1|Outcome|IVIG Active Treatment|Intravenous Immunoglobulin (IVIG) active treatment for infants with biliary atresia
126326|NCT01854827|O1|Outcome|IVIG Active Treatment|Intravenous Immunoglobulin (IVIG) active treatment for infants with biliary atresia
126327|NCT01854827|O1|Outcome|IVIG Active Treatment|Intravenous Immunoglobulin (IVIG) active treatment for infants with biliary atresia
126328|NCT01854827|O1|Outcome|IVIG Active Treatment|Intravenous Immunoglobulin (IVIG) active treatment for infants with biliary atresia
126329|NCT01854827|O1|Outcome|IVIG Active Treatment|Intravenous Immunoglobulin (IVIG) active treatment for infants with biliary atresia
126330|NCT01854827|O1|Outcome|IVIG Active Treatment|Intravenous Immunoglobulin (IVIG) active treatment for infants with biliary atresia
126331|NCT01854827|O1|Outcome|IVIG Active Treatment|Intravenous Immunoglobulin (IVIG) active treatment for infants with biliary atresia
126332|NCT01854827|E1|Reported Event|IVIG Active Treatment|Intravenous Immunoglobulin (IVIG) active treatment for infants with biliary atresia
126333|NCT01854710|B1|Baseline|All Subjects Treated|All 6 treatment sequences = Safety Population
126334|NCT01854710|P6|Participant Flow|Treatment Sequence CBA|Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo
126335|NCT01854710|P5|Participant Flow|Treatment Sequence CAB|Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo
126336|NCT01854710|P4|Participant Flow|Treatment Sequence BAC|Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo
126337|NCT01854710|P3|Participant Flow|Treatment Sequence BCA|Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo
126338|NCT01854710|P2|Participant Flow|Treatment Sequence ACB|Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo
126339|NCT01854710|P1|Participant Flow|Treatment Sequence ABC|Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo
126340|NCT01854710|O1|Outcome|Moxifloxacin QT Crossover Subjects|"All subjects who completed both Treatments B and C: B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo.~Analyses are based on a within (paired) comparison of the time matched drug - placebo QTc values."
126341|NCT01854710|O2|Outcome|ADASUVE 10 mg x 2 Doses|"ADASUVE 10 mg 2 doses 2 hours apart + Oral Placebo~ADASUVE 10 mg 2 doses 2 hours apart: inhaled loxapine~Placebo (for moxifloxacin): placebo capsule to mimic moxifloxacin 400 mg"
126342|NCT01854710|O1|Outcome|Inhaled Placebo + Oral Placebo|"Staccato Placebo 2 doses 2 hours apart + Oral Placebo~Staccato Placebo 2 doses 2 hours apart: Inhaler with no drug in it to mimic the ADASUVE inhaler~Placebo (for moxifloxacin): placebo capsule to mimic moxifloxacin 400 mg"
126343|NCT01854710|O2|Outcome|ADASUVE 10 mg x 2 Doses|"ADASUVE 10 mg 2 doses 2 hours apart + Oral Placebo~ADASUVE 10 mg 2 doses 2 hours apart: inhaled loxapine~Placebo (for moxifloxacin): placebo capsule to mimic moxifloxacin 400 mg"
126344|NCT01854710|O1|Outcome|Inhaled Placebo + Oral Placebo|"Staccato Placebo 2 doses 2 hours apart + Oral Placebo~Staccato Placebo 2 doses 2 hours apart: Inhaler with no drug in it to mimic the ADASUVE inhaler~Placebo (for moxifloxacin): placebo capsule to mimic moxifloxacin 400 mg"
126345|NCT01854710|O2|Outcome|ADASUVE 10 mg x 2 Doses|"ADASUVE 10 mg 2 doses 2 hours apart + Oral Placebo~ADASUVE 10 mg 2 doses 2 hours apart: inhaled loxapine~Placebo (for moxifloxacin): placebo capsule to mimic moxifloxacin 400 mg"
126346|NCT01854710|O1|Outcome|Inhaled Placebo + Oral Placebo|"Staccato Placebo 2 doses 2 hours apart + Oral Placebo~Staccato Placebo 2 doses 2 hours apart: Inhaler with no drug in it to mimic the ADASUVE inhaler~Placebo (for moxifloxacin): placebo capsule to mimic moxifloxacin 400 mg"
126347|NCT01854710|O2|Outcome|ADASUVE 10 mg x 2 Doses|"ADASUVE 10 mg 2 doses 2 hours apart + Oral Placebo~ADASUVE 10 mg 2 doses 2 hours apart: inhaled loxapine~Placebo (for moxifloxacin): placebo capsule to mimic moxifloxacin 400 mg"
126348|NCT01854710|O1|Outcome|Inhaled Placebo + Oral Placebo|"Staccato Placebo 2 doses 2 hours apart + Oral Placebo~Staccato Placebo 2 doses 2 hours apart: Inhaler with no drug in it to mimic the ADASUVE inhaler~Placebo (for moxifloxacin): placebo capsule to mimic moxifloxacin 400 mg"
126349|NCT01854710|O1|Outcome|ADASUVE 10 mg x 2 Doses|"ADASUVE QTcI, Differences from Placebo in Change from Pre-dose Baseline and One-sided 95% Upper Confidence Bound (msec)~QTcI associated with mean Cmax"
126350|NCT01854710|O1|Outcome|ADASUVE-Placebo Crossover Subjects|"All subjects who completed both treatments A and B: Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo.~The analyses are based on a within (paired) comparison of the time matched drug - placebo QTc values."
126351|NCT01854710|E3|Reported Event|Oral Moxifloxacin|"Staccato Placebo 2 doses 2 hours apart + Oral moxifloxacin 400 mg~Oral moxifloxacin 400 mg~Staccato Placebo 2 doses 2 hours apart: Inhaler with no drug in it to mimic the ADASUVE inhaler"
126382|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
126352|NCT01854710|E2|Reported Event|ADASUVE 10 mg x 2 Doses|"ADASUVE 10 mg 2 doses 2 hours apart + Oral Placebo~ADASUVE 10 mg 2 doses 2 hours apart: inhaled loxapine~Placebo (for moxifloxacin): placebo capsule to mimic moxifloxacin 400 mg"
126353|NCT01854710|E1|Reported Event|Inhaled Placebo + Oral Placebo|"Staccato Placebo 2 doses 2 hours apart + Oral Placebo~Staccato Placebo 2 doses 2 hours apart: Inhaler with no drug in it to mimic the ADASUVE inhaler~Placebo (for moxifloxacin): placebo capsule to mimic moxifloxacin 400 mg"
126354|NCT01854697|B6|Baseline|Total|Total of all reporting groups
126355|NCT01854697|B5|Baseline|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
126356|NCT01854697|B4|Baseline|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
126357|NCT01854697|B3|Baseline|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
126358|NCT01854697|B2|Baseline|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
126359|NCT01854697|B1|Baseline|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
126360|NCT01854697|P5|Participant Flow|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
126361|NCT01854697|P4|Participant Flow|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
126362|NCT01854697|P3|Participant Flow|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
126363|NCT01854697|P2|Participant Flow|Arm B: TPV/PR in GT1a|Telaprevir (TPV) 750 mg every 8 hours (q8h) and pegylated interferon (pegIFN) 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
126364|NCT01854697|P1|Participant Flow|Arm A: 3-DAA + RBV in GT1a|ABT-450/ritonavir (r)/ABT-267 150 mg/100 mg/25 mg once daily (QD) and ABT-333 250 mg twice daily (BID) and weight-based ribavirin (RBV) for 12 weeks (3 Direct-Acting Antivirals (DAAs) with RBV in genotype [GT] 1a)
126365|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
126366|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
126367|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
126368|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
126369|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
126370|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
126371|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
126372|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
126373|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
126374|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
126375|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
126376|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
126377|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
126378|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
126379|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
126380|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
126381|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
144022|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
126383|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
126384|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
126385|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
126386|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
126387|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
126388|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
126389|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
126390|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
126391|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
126392|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
126393|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
126394|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
126395|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
126396|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
126397|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
126398|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
126399|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
126400|NCT01854697|E3|Reported Event|TPV + PEGIFN + RBV|TPV 750 mg q8h and pegIFN 180 μg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir
126401|NCT01854697|E2|Reported Event|3 DAA|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks
126402|NCT01854697|E1|Reported Event|3 DAA + RBV|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks
126403|NCT01854658|B5|Baseline|Total|Total of all reporting groups
126404|NCT01854658|B4|Baseline|Placebo MDI|Inhaled placebo administered as two puffs BID
126405|NCT01854658|B3|Baseline|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
126406|NCT01854658|B2|Baseline|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
126407|NCT01854658|B1|Baseline|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
126408|NCT01854658|P4|Participant Flow|Placebo MDI|Inhaled placebo administered as two puffs BID
126409|NCT01854658|P3|Participant Flow|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
126410|NCT01854658|P2|Participant Flow|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
126411|NCT01854658|P1|Participant Flow|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
126412|NCT01854658|O4|Outcome|Placebo MDI|Inhaled placebo administered as two puffs BID
126413|NCT01854658|O3|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
126414|NCT01854658|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
126415|NCT01854658|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
126416|NCT01854658|O4|Outcome|Placebo MDI|Inhaled placebo administered as two puffs BID
126417|NCT01854658|O3|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
126418|NCT01854658|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
126419|NCT01854658|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
126420|NCT01854658|O4|Outcome|Placebo MDI|Inhaled placebo administered as two puffs BID
126421|NCT01854658|O3|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
126422|NCT01854658|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
126423|NCT01854658|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
126424|NCT01854658|O4|Outcome|Placebo MDI|Inhaled placebo administered as two puffs BID
126425|NCT01854658|O3|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
126426|NCT01854658|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
126427|NCT01854658|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
126454|NCT01854645|O2|Outcome|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
126455|NCT01854645|O1|Outcome|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
126456|NCT01854645|O5|Outcome|Placebo|Placebo MDI
126457|NCT01854645|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
126458|NCT01854645|O3|Outcome|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
126459|NCT01854645|O2|Outcome|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
126460|NCT01854645|O1|Outcome|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
126461|NCT01854645|O5|Outcome|Placebo|Placebo MDI
126462|NCT01854645|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
126463|NCT01854645|O3|Outcome|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
126464|NCT01854645|O2|Outcome|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
126465|NCT01854645|O1|Outcome|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
126466|NCT01854645|O5|Outcome|Placebo|Placebo MDI
126467|NCT01854645|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
126468|NCT01854645|O3|Outcome|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
126469|NCT01854645|O2|Outcome|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
126470|NCT01854645|O1|Outcome|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
126471|NCT01854645|O5|Outcome|Placebo|Placebo MDI
126472|NCT01854645|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
126473|NCT01854645|O3|Outcome|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
126474|NCT01854645|O2|Outcome|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
126475|NCT01854645|O1|Outcome|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
126476|NCT01854645|O5|Outcome|Placebo|Placebo MDI
126477|NCT01854645|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
126478|NCT01854645|O3|Outcome|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
126479|NCT01854645|O2|Outcome|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
126480|NCT01854645|O1|Outcome|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
126481|NCT01854645|E5|Reported Event|Placebo|Placebo MDI
126482|NCT01854645|E4|Reported Event|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
126483|NCT01854645|E3|Reported Event|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
126484|NCT01854645|E2|Reported Event|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
126485|NCT01854645|E1|Reported Event|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
126486|NCT01854632|B3|Baseline|Total|Total of all reporting groups
126487|NCT01854632|B2|Baseline|Placebo|Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
126488|NCT01854632|B1|Baseline|Vaccine|Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
126489|NCT01854632|P2|Participant Flow|Placebo|Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
126490|NCT01854632|P1|Participant Flow|Vaccine|Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
126491|NCT01854632|O2|Outcome|Placebo|Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
126492|NCT01854632|O1|Outcome|Vaccine|Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
126493|NCT01854632|E2|Reported Event|Placebo|Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
126494|NCT01854632|E1|Reported Event|Vaccine|Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
126495|NCT01854593|B3|Baseline|Total|Total of all reporting groups
126496|NCT01854593|B2|Baseline|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Sham injection: Sham injection one day before vitrectomy~Vitrectomy: vitrectomy of 25 gauge system."
126497|NCT01854593|B1|Baseline|Bevacizumab and Vitrectomy|"0.16 mg/0.05 ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
126498|NCT01854593|P2|Participant Flow|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Sham injection: Sham injection one day before vitrectomy~Vitrectomy: vitrectomy of 25 gauge system."
126499|NCT01854593|P1|Participant Flow|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
126500|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
126501|NCT01854593|O1|Outcome|Bevacizumab Injection and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
127334|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
126502|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
126503|NCT01854593|O1|Outcome|Bevacizumab Injection and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
126504|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
126505|NCT01854593|O1|Outcome|Bevacizumab Injection and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
126506|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
126507|NCT01854593|O1|Outcome|Bevacizumab Injection and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
126508|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
126509|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
126510|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
126511|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
126512|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
126513|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
126514|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
126515|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
126516|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
126517|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
126518|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
126519|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
126520|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
126521|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
126522|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
126523|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
126524|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
126525|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
126526|NCT01854593|E2|Reported Event|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
126527|NCT01854593|E1|Reported Event|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
126528|NCT01854528|B3|Baseline|Total|Total of all reporting groups
126529|NCT01854528|B2|Baseline|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
126530|NCT01854528|B1|Baseline|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
126531|NCT01854528|P2|Participant Flow|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
126532|NCT01854528|P1|Participant Flow|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
126533|NCT01854528|O2|Outcome|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
126534|NCT01854528|O1|Outcome|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
126535|NCT01854528|O2|Outcome|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
126536|NCT01854528|O1|Outcome|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
126537|NCT01854528|O2|Outcome|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
126538|NCT01854528|O1|Outcome|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
126539|NCT01854528|O2|Outcome|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
126540|NCT01854528|O1|Outcome|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
126541|NCT01854528|O2|Outcome|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
126542|NCT01854528|O1|Outcome|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
126543|NCT01854528|O2|Outcome|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
126544|NCT01854528|O1|Outcome|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
126545|NCT01854528|E2|Reported Event|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
126546|NCT01854528|E1|Reported Event|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
126547|NCT01854281|B5|Baseline|Total|Total of all reporting groups
126548|NCT01854281|B4|Baseline|Patent Foramen Ovale Dive B Group|Divers with a previously diagnosed patent foramen ovale observed after dive B.
126549|NCT01854281|B3|Baseline|Closure Dive B Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B.
126550|NCT01854281|B2|Baseline|Patent Foramen Ovale Dive A Group|Divers with a previously diagnosed patent foramen ovale observed after dive A.
126551|NCT01854281|B1|Baseline|Closure Dive A Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A.
126552|NCT01854281|P4|Participant Flow|Patent Foramen Ovale Dive B Group|Divers with a previously diagnosed patent foramen ovale observed after Dive B.
126553|NCT01854281|P3|Participant Flow|Closure Dive B Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B.
126554|NCT01854281|P2|Participant Flow|Patent Foramen Ovale Dive A Group|Divers with a previously diagnosed patent foramen ovale observed after Dive A.
126555|NCT01854281|P1|Participant Flow|Closure Dive A Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A.
126556|NCT01854281|O4|Outcome|Patent Foramen Ovale Dive B Group|Divers with a previously diagnosed patent foramen ovale observed after dive B.
126557|NCT01854281|O3|Outcome|Closure Dive B Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B.
126558|NCT01854281|O2|Outcome|Patent Foramen Ovale Dive A Group|Divers with a previously diagnosed patent foramen ovale observed after dive A.
126559|NCT01854281|O1|Outcome|Closure Dive A Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A.
126560|NCT01854281|E4|Reported Event|Patent Foramen Ovale Dive B Group|Divers with a previously diagnosed patent foramen ovale observed after dive B.
144023|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
126561|NCT01854281|E3|Reported Event|Closure Dive B Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B.
126562|NCT01854281|E2|Reported Event|Patent Foramen Ovale Dive A Group|Divers with a previously diagnosed patent foramen ovale observed after dive A.
126563|NCT01854281|E1|Reported Event|Closure Dive A Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A.
126564|NCT01854268|B1|Baseline|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.~Healthy adults who receive capsaicin: Participants were seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant breathed through a facemask attached to a pneumotachograph, nebulizer, and dosimeter. The participant received 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants had a minute in between each presentation and water was available at all times.~Pulmonary function testing: Investigators will first place cotton elastic bands around your chest and abdomen so that measures of chest wall and abdominal movements can be measured. Forced vital capacity and rest breathing maneuvers were completed.~Nebulized water (Fog): The investigators will provide you with nebulized water (FOG) through the facemask for up to a minute three times. A minute break in between each presentation."
126565|NCT01854268|P1|Participant Flow|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.~Healthy adults received capsaicin: Participants were seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in the chest wall and abdomen during cough. Participants breathed through a facemask attached to a pneumotachograph, nebulizer, and dosimeter. Participants received 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants rested for a minute in between each presentation and water was available at all times.~Pulmonary function testing: Investigators placed cotton elastic bands around the chest and abdomen so that measures of chest wall and abdominal movements could be measured. Forced vital capacity and rest breathing was completed.~Nebulized water (Fog): The investigators provided nebulized water (FOG) through the facemask for up to a minute three times. A minute break was allotted between each presentation."
126566|NCT01854268|O1|Outcome|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.~Healthy adults who receive capsaicin: Participants will be seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant will hold a facemask attached to a pneumotachograph, nebulized, and dosimeter. The participant will receive 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants will have a minute in between each presentation and water will be available at all times."
126567|NCT01854268|O1|Outcome|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.~Healthy adults who receive capsaicin: Participants will be seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant will hold a facemask attached to a pneumotachograph, nebulized, and dosimeter. The participant will receive 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants will have a minute in between each presentation and water will be available at all times."
126568|NCT01854268|O1|Outcome|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.~Healthy adults who receive capsaicin: Participants will be seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant will hold a facemask attached to a pneumotachograph, nebulized, and dosimeter. The participant will receive 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants will have a minute in between each presentation and water will be available at all times."
126569|NCT01854268|E1|Reported Event|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.~Healthy adults received capsaicin: Participants were seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant breathed through a facemask attached to a pneumotachograph, nebulizer, and dosimeter. The participant received 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants had a minute in between each presentation and water will be available at all times."
126570|NCT01854242|B1|Baseline|Glycogen Storage Disease Type Ia Patients|The participants will have one blood draw for this study. The test will be performed on the blood.
126571|NCT01854242|P1|Participant Flow|Glycogen Storage Disease Type Ia Patients|The participants will have one blood draw for this study. The test will be performed on the blood.
126572|NCT01854242|O1|Outcome|Glycogen Storage Disease Type Ia Patients|The participants will have one blood draw for this study. The test will be performed on the blood.
126573|NCT01854242|E1|Reported Event|Glycogen Storage Disease Type Ia Patients|The participants will have one blood draw for this study. The test will be performed on the blood.
126574|NCT01854047|B6|Baseline|Total|Total of all reporting groups
126575|NCT01854047|B5|Baseline|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126576|NCT01854047|B4|Baseline|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126577|NCT01854047|B3|Baseline|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126578|NCT01854047|B2|Baseline|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126579|NCT01854047|B1|Baseline|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126580|NCT01854047|P5|Participant Flow|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126581|NCT01854047|P4|Participant Flow|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126582|NCT01854047|P3|Participant Flow|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126583|NCT01854047|P2|Participant Flow|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126584|NCT01854047|P1|Participant Flow|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable inhaled corticosteroid/ long-acting beta-agonist (ICS/LABA) therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126585|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126586|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126587|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126588|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126589|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126590|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126591|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126592|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126593|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126594|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126595|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126596|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126597|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126598|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126599|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126600|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126601|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126602|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126603|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126604|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126605|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126606|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126607|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126608|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126609|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126610|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126611|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126612|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126613|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126614|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126615|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126616|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126617|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126618|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126619|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126620|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126621|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
144024|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
126622|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126623|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126624|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126625|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126626|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126627|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126628|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126629|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126630|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126631|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126632|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126633|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126634|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126635|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126636|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126637|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126638|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126639|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126640|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126641|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126642|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126767|NCT01853605|O2|Outcome|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
126643|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126644|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126645|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126646|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126647|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126648|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126649|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126650|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126651|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126652|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126653|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126654|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126655|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126656|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126657|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126658|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126659|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126660|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126661|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126662|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126663|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126768|NCT01853605|O1|Outcome|Augmentation|Women undergoing breast augmentation.
126664|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126665|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126666|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126667|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126668|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126669|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126670|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126671|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126672|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126673|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126674|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126675|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126676|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126677|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126678|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126679|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126680|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126681|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126682|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126683|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126684|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126769|NCT01853605|O4|Outcome|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
126685|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126686|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126687|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126688|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126689|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126690|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126691|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126692|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126693|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126694|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126695|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126696|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126697|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126698|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126699|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
126700|NCT01854047|E5|Reported Event|Dupilumab 200 mg q4w|Participants exposed to Dupilumab 200 mg alternating with placebo q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks).
126701|NCT01854047|E4|Reported Event|Dupilumab 300 mg q4w|Participants exposed to Dupilumab 300 mg alternating with placebo q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks).
126702|NCT01854047|E3|Reported Event|Dupilumab 200 mg q2w|Participants exposed to Dupilumab 200 mg q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks).
126703|NCT01854047|E2|Reported Event|Dupilumab 300 mg q2w|Participants exposed to Dupilumab 300 mg q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks).
126704|NCT01854047|E1|Reported Event|Placebo|Participants exposed to Placebo (for Dupilumab) added to stable ICS/LABA therapy (mean exposure of 23 weeks).
126705|NCT01854034|B1|Baseline|AUY922 Treatment Arm|AUY922 administered intravenously once a week at 70mg/m2
126706|NCT01854034|P1|Participant Flow|AUY922 Treatment Arm|AUY922 administered intravenously once a week at 70mg/m2
126707|NCT01854034|O1|Outcome|AUY922 Treatment Arm|AUY922 administered intravenously once a week at 70mg/m2
126708|NCT01854034|O1|Outcome|AUY922 Treatment Arm|AUY922 administered intravenously once a week at 70mg/m2
126709|NCT01854034|O1|Outcome|AUY922 Treatment Arm|AUY922 administered intravenously once a week at 70mg/m2
126710|NCT01854034|O1|Outcome|AUY922 Treatment Arm|AUY922 administered intravenously once a week at 70mg/m2
126711|NCT01854034|E1|Reported Event|AUY922 Treatment Arm|AUY922 administered intravenously once a week at 70mg/m2
126712|NCT01853982|B3|Baseline|Total|Total of all reporting groups
126713|NCT01853982|B2|Baseline|Piperacillin/Tazobactam|4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
126770|NCT01853605|O3|Outcome|Reconstruction|Women undergoing breast reconstruction.
126714|NCT01853982|B1|Baseline|Ceftolozane/Tazobactam|3000 mg ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered IV, every 8 hours for 8 days
126715|NCT01853982|P2|Participant Flow|Piperacillin/Tazobactam|4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
126716|NCT01853982|P1|Participant Flow|Ceftolozane/Tazobactam|3000 milligrams (mg) ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered intravenously (IV), every 8 hours for 8 days
126717|NCT01853982|O2|Outcome|Piperacillin/Tazobactam|4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
126718|NCT01853982|O1|Outcome|Ceftolozane/Tazobactam|3000 mg ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered IV, every 8 hours for 8 days
126719|NCT01853982|E2|Reported Event|Piperacillin/Tazobactam|4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
126720|NCT01853982|E1|Reported Event|Ceftolozane/Tazobactam|3000 mg ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered IV, every 8 hours for 8 days
126721|NCT01853839|B1|Baseline|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~All antihypertensive drugs will be prescribed and administered according to the approved prescribing information in the country where the patient resides. Treatment duration is up to 52 weeks."
126722|NCT01853839|P1|Participant Flow|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~All antihypertensive drugs will be prescribed and administered according to the approved prescribing information in the country where the patient resides. Treatment duration is up to 52 weeks."
126723|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
126724|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
126725|NCT01853839|O2|Outcome|Non-Fasting|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients who did not fast for Ramadan."
126726|NCT01853839|O1|Outcome|Fasting|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients who did fast for Ramadan."
126727|NCT01853839|O2|Outcome|Non-Fasting|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients who did not fast for Ramadan."
126728|NCT01853839|O1|Outcome|Fasting|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients who did fast for Ramadan."
126729|NCT01853839|O2|Outcome|Internist|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients whose primary physician was a internist."
126730|NCT01853839|O1|Outcome|Cardiologist|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients whose primary physician was a cardiologist."
126731|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
126732|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
126733|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
126734|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
126735|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
126736|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
126737|NCT01853839|O2|Outcome|Non-Fasting|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients who did not fast for Ramadan."
126738|NCT01853839|O1|Outcome|Fasting|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients who did fast for Ramadan."
126739|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
126740|NCT01853839|E1|Reported Event|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~All antihypertensive drugs will be prescribed and administered according to the approved prescribing information in the country where the patient resides. Treatment duration is up to 52 weeks."
126741|NCT01853696|B3|Baseline|Total|Total of all reporting groups
126742|NCT01853696|B2|Baseline|Prednisolone Acetate|"Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months~prednisolone acetate 1%"
126743|NCT01853696|B1|Baseline|Loteprednol|"Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months~loteprednol etabonate"
126744|NCT01853696|P2|Participant Flow|Prednisolone Acetate|"Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months~prednisolone acetate 1%"
126745|NCT01853696|P1|Participant Flow|Loteprednol|"Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months~loteprednol etabonate 0.5% gel"
126746|NCT01853696|O2|Outcome|Prednisolone Acetate|"Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months~prednisolone acetate 1%"
126747|NCT01853696|O1|Outcome|Loteprednol|"Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months~loteprednol etabonate 0.5% gel"
126748|NCT01853696|O2|Outcome|Prednisolone Acetate|"Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months~prednisolone acetate 1%"
126749|NCT01853696|O1|Outcome|Loteprednol|"Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months~loteprednol etabonate 0.5% gel"
126750|NCT01853696|E2|Reported Event|Prednisolone Acetate|"Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months~prednisolone acetate 1%"
126751|NCT01853696|E1|Reported Event|Loteprednol|"Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months~loteprednol etabonate 0.5% gel"
126752|NCT01853605|B5|Baseline|Total|Total of all reporting groups
126753|NCT01853605|B4|Baseline|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
126754|NCT01853605|B3|Baseline|Reconstruction|Women undergoing breast reconstruction.
126755|NCT01853605|B2|Baseline|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
126756|NCT01853605|B1|Baseline|Augmentation|Women undergoing breast augmentation.
126757|NCT01853605|P4|Participant Flow|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
126758|NCT01853605|P3|Participant Flow|Reconstruction|Women undergoing breast reconstruction.
126759|NCT01853605|P2|Participant Flow|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
126760|NCT01853605|P1|Participant Flow|Augmentation|Women undergoing breast augmentation.
126761|NCT01853605|O4|Outcome|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
126762|NCT01853605|O3|Outcome|Reconstruction|Women undergoing breast reconstruction.
126763|NCT01853605|O2|Outcome|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
126764|NCT01853605|O1|Outcome|Augmentation|Women undergoing breast augmentation.
126765|NCT01853605|O4|Outcome|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
126766|NCT01853605|O3|Outcome|Reconstruction|Women undergoing breast reconstruction.
126771|NCT01853605|O2|Outcome|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
126772|NCT01853605|O1|Outcome|Augmentation|Women undergoing breast augmentation.
126773|NCT01853605|E4|Reported Event|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
126774|NCT01853605|E3|Reported Event|Reconstruction|Women undergoing breast reconstruction.
126775|NCT01853605|E2|Reported Event|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
126776|NCT01853605|E1|Reported Event|Augmentation|Women undergoing breast augmentation.
126777|NCT01853475|B4|Baseline|Total|Total of all reporting groups
126778|NCT01853475|B3|Baseline|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
126779|NCT01853475|B2|Baseline|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
126780|NCT01853475|B1|Baseline|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
126781|NCT01853475|P3|Participant Flow|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
126782|NCT01853475|P2|Participant Flow|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
126783|NCT01853475|P1|Participant Flow|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
126784|NCT01853475|O3|Outcome|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
126785|NCT01853475|O2|Outcome|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
126786|NCT01853475|O1|Outcome|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
126787|NCT01853475|O3|Outcome|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
126788|NCT01853475|O2|Outcome|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
126789|NCT01853475|O1|Outcome|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
126790|NCT01853475|O3|Outcome|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
126791|NCT01853475|O2|Outcome|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
126792|NCT01853475|O1|Outcome|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
126793|NCT01853475|O3|Outcome|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
126794|NCT01853475|O2|Outcome|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
126795|NCT01853475|O1|Outcome|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
126796|NCT01853475|E3|Reported Event|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
126797|NCT01853475|E2|Reported Event|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
126798|NCT01853475|E1|Reported Event|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
126799|NCT01853397|B5|Baseline|Total|Total of all reporting groups
126800|NCT01853397|B4|Baseline|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
126801|NCT01853397|B3|Baseline|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
126802|NCT01853397|B2|Baseline|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
126803|NCT01853397|B1|Baseline|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
126804|NCT01853397|P4|Participant Flow|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
126805|NCT01853397|P3|Participant Flow|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
126806|NCT01853397|P2|Participant Flow|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
126807|NCT01853397|P1|Participant Flow|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
126808|NCT01853397|O4|Outcome|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
126809|NCT01853397|O3|Outcome|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
126810|NCT01853397|O2|Outcome|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
126811|NCT01853397|O1|Outcome|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
126812|NCT01853397|O4|Outcome|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
126813|NCT01853397|O3|Outcome|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
126814|NCT01853397|O2|Outcome|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
126815|NCT01853397|O1|Outcome|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
126816|NCT01853397|O4|Outcome|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
126817|NCT01853397|O3|Outcome|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
126818|NCT01853397|O2|Outcome|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
126819|NCT01853397|O1|Outcome|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
126820|NCT01853397|O4|Outcome|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
126821|NCT01853397|O3|Outcome|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
126822|NCT01853397|O2|Outcome|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
126823|NCT01853397|O1|Outcome|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
126824|NCT01853397|O4|Outcome|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
126825|NCT01853397|O3|Outcome|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
126826|NCT01853397|O2|Outcome|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
126827|NCT01853397|O1|Outcome|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
126828|NCT01853397|E4|Reported Event|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
126829|NCT01853397|E3|Reported Event|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
126830|NCT01853397|E2|Reported Event|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
126831|NCT01853397|E1|Reported Event|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
126832|NCT01853384|B3|Baseline|Total|Total of all reporting groups
126833|NCT01853384|B2|Baseline|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
126834|NCT01853384|B1|Baseline|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
126835|NCT01853384|P2|Participant Flow|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
126836|NCT01853384|P1|Participant Flow|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
126837|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
126838|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
126839|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
127335|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
126840|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
126841|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
126842|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
126843|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
126844|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
126845|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
126846|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
126847|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
126848|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
126849|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
126850|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
126851|NCT01853384|E2|Reported Event|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
126852|NCT01853384|E1|Reported Event|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
126853|NCT01853371|B3|Baseline|Total|Total of all reporting groups
127036|NCT01852812|B2|Baseline|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
127506|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
126854|NCT01853371|B2|Baseline|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
126855|NCT01853371|B1|Baseline|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin. In this study, the wet cupping procedure was not done on certain days of the lunar month.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment."
126856|NCT01853371|P2|Participant Flow|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
126857|NCT01853371|P1|Participant Flow|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other. The wet cupping procedure was not done on certain days of the lunar month.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
126858|NCT01853371|O2|Outcome|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
126859|NCT01853371|O1|Outcome|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin. In this study, the wet cupping procedure was not done on certain days of the lunar month.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment."
126860|NCT01853371|O2|Outcome|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
126861|NCT01853371|O1|Outcome|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin. In this study, the wet cupping procedure was not done on certain days of the lunar month.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment."
126862|NCT01853371|E2|Reported Event|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
126863|NCT01853371|E1|Reported Event|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin. In this study, the wet cupping procedure was not done on certain days of the lunar month.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment."
126864|NCT01853332|B1|Baseline|Cross-Sectional|New and Former Participants
126865|NCT01853332|P1|Participant Flow|Cross-Sectional|"New participants: The purpose of the study is to learn about physical health in midlife and how it has been influenced by experiences and relationships. The study specifically targets health differences and the development of heart disease and diabetes.~AND~Former participants (or the partner of a former participant) of the Adolescent and Family Development Project, Young Adult Development Project, Across Generations Project, and/or Paths Over Time Project may already know that this research shows how people grow, individually and as part of a familial and social network, throughout the course of life. This study focuses on learning about former participants' physical health in midlife and how it has been influenced by their experiences and relationships."
126866|NCT01853332|O1|Outcome|Cross-Sectional|New participants and former participants studied cross-sectionally.
126867|NCT01853332|O1|Outcome|Cross-Sectional|New participants and former participants studied cross-sectionally.
126868|NCT01853332|O1|Outcome|Cross-Sectional|New participants and former participants studied cross-sectionally.
126869|NCT01853332|O1|Outcome|Cross-Sectional|New participants and former participants studied cross-sectionally.
126870|NCT01853332|O1|Outcome|Cross-Sectional|New participants and former participants studied cross-sectionally.
126871|NCT01853332|O1|Outcome|Cross-Sectional|New participants and former participants
126872|NCT01853332|E1|Reported Event|Cross-Sectional|New and Former Participants
126873|NCT01853280|B3|Baseline|Total|Total of all reporting groups
126874|NCT01853280|B2|Baseline|Placebo (for L-Methylfolate)|15 mg matched placebo comparator with open-label OROS-Methylphenidate
126875|NCT01853280|B1|Baseline|L-Methylfolate|15 mg of L-Methylfolate (Deplin) daily for 12 weeks as a supplement to OROS-Methylphenidate.
126876|NCT01853280|P2|Participant Flow|Placebo (for L-Methylfolate)|15 mg matched placebo comparator with open-label OROS-Methylphenidate
126877|NCT01853280|P1|Participant Flow|L-Methylfolate|15 mg of L-Methylfolate (Deplin) daily for 12 weeks as a supplement to OROS-Methylphenidate.
126878|NCT01853280|O2|Outcome|Placebo (for L-Methylfolate)|15 mg matched placebo comparator with open-label OROS-Methylphenidate
126879|NCT01853280|O1|Outcome|L-Methylfolate|15 mg of L-Methylfolate (Deplin) daily for 12 weeks as a supplement to OROS-Methylphenidate.
126880|NCT01853280|E2|Reported Event|Placebo (for L-Methylfolate)|15 mg matched placebo comparator with open-label OROS-Methylphenidate
126881|NCT01853280|E1|Reported Event|L-Methylfolate|15 mg of L-Methylfolate (Deplin) daily for 12 weeks as a supplement to OROS-Methylphenidate.
126882|NCT01853254|B1|Baseline|Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin|The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
126883|NCT01853254|P1|Participant Flow|Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin|The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
126884|NCT01853254|O1|Outcome|Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin|The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
126885|NCT01853254|E1|Reported Event|Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin|The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
126886|NCT01853215|B1|Baseline|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N. Sternal Manual Intraosseous Needle set~T.A.L.O.N. Sternal Manual Intraosseous Needle set : intraosseous catheter for use in the sternum"
126887|NCT01853215|P1|Participant Flow|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
126888|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
126889|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
126890|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
126891|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
126892|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System : intraosseous catheter for use in the sternum"
126893|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
126894|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
126895|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System : intraosseous catheter for use in the sternum"
126896|NCT01853215|E1|Reported Event|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N. Sternal Manual Intraosseous Needle set~T.A.L.O.N. Sternal Manual Intraosseous Needle set : intraosseous catheter for use in the sternum"
126897|NCT01853176|B3|Baseline|Total|Total of all reporting groups
126898|NCT01853176|B2|Baseline|Standard Bupivicaine|"Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Standard bupivicaine"
126899|NCT01853176|B1|Baseline|Liposomal Injection Bupivicaine (Exparel)|"Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Liposomal Injection Bupivacaine (Exparel)"
126900|NCT01853176|P2|Participant Flow|Standard Bupivicaine|"Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Standard bupivicaine"
127151|NCT01852110|B2|Baseline|Placebo (Stage 1)|Matching placebo to MK-7622 capsule once daily, taken orally.
126901|NCT01853176|P1|Participant Flow|Liposomal Injection Bupivicaine (Exparel)|"Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Liposomal Injection Bupivacaine (Exparel)"
126902|NCT01853176|O2|Outcome|Standard Bupivicaine|"Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Standard bupivicaine"
126903|NCT01853176|O1|Outcome|Liposomal Injection Bupivicaine (Exparel)|"Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Liposomal Injection Bupivacaine (Exparel)"
126904|NCT01853176|E2|Reported Event|Standard Bupivicaine|"Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Standard bupivicaine"
126905|NCT01853176|E1|Reported Event|Liposomal Injection Bupivicaine (Exparel)|"Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Liposomal Injection Bupivacaine (Exparel)"
126906|NCT01853085|B1|Baseline|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
126907|NCT01853085|P1|Participant Flow|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
126908|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
126909|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
126910|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
126911|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
126912|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
126913|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
126914|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
126915|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
126916|NCT01853085|E1|Reported Event|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
126917|NCT01853072|B3|Baseline|Total|Total of all reporting groups
126918|NCT01853072|B2|Baseline|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
126919|NCT01853072|B1|Baseline|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
126920|NCT01853072|P2|Participant Flow|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
126921|NCT01853072|P1|Participant Flow|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
126922|NCT01853072|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
126923|NCT01853072|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
126924|NCT01853072|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
126925|NCT01853072|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
126926|NCT01853072|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
126927|NCT01853072|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
126928|NCT01853072|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
126929|NCT01853072|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
126930|NCT01853072|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
126931|NCT01853072|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
126932|NCT01853072|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
126933|NCT01853072|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
126934|NCT01853072|E4|Reported Event|Posttreatment|All participants after cessation of study treatment up to study exit
126935|NCT01853072|E3|Reported Event|Vehicle|All participants treated with NepafenacVehicle during the course of study treatment
126936|NCT01853072|E2|Reported Event|Nepafenac|All participants treated with Nepafenac during the course of study treatment
126937|NCT01853072|E1|Reported Event|Pretreatment|All participants who consented to participate in the study prior to the initiation of study treatment
126938|NCT01853046|B3|Baseline|Total|Total of all reporting groups
126939|NCT01853046|B2|Baseline|Regorafenib (Stivarga, BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126940|NCT01853046|B1|Baseline|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126941|NCT01853046|P2|Participant Flow|Regorafenib (Stivarga, BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126942|NCT01853046|P1|Participant Flow|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126943|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126944|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126945|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126946|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126947|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126948|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126949|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126950|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126951|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126952|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126953|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126954|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126955|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
127037|NCT01852812|B1|Baseline|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
126956|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126957|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126958|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126959|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126960|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126961|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126962|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126963|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126964|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126965|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126966|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126967|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126968|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126969|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126970|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126971|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
127038|NCT01852812|P3|Participant Flow|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
147518|NCT01761279|O1|Outcome|HDWL|High Definition White Light Endoscopy
126972|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126973|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126974|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126975|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126976|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126977|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126978|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126979|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126980|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126981|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126982|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126983|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126984|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days
126985|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126986|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126987|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
127039|NCT01852812|P2|Participant Flow|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg chewable tablets (CT) in one tablet PO QD at bed time for 12 weeks
149709|NCT01748955|B3|Baseline|Total|Total of all reporting groups
126988|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126989|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126990|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126991|NCT01853046|E2|Reported Event|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126992|NCT01853046|E1|Reported Event|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
126993|NCT01852955|B3|Baseline|Total|Total of all reporting groups
126994|NCT01852955|B2|Baseline|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen~Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
126995|NCT01852955|B1|Baseline|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.~IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
126996|NCT01852955|P2|Participant Flow|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen~Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
126997|NCT01852955|P1|Participant Flow|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.~IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
126998|NCT01852955|O2|Outcome|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen~Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
126999|NCT01852955|O1|Outcome|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.~IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
127000|NCT01852955|O2|Outcome|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen~Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
127001|NCT01852955|O1|Outcome|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.~IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
127002|NCT01852955|O2|Outcome|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen~Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
127003|NCT01852955|O1|Outcome|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.~IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
127004|NCT01852955|E2|Reported Event|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen~Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
127005|NCT01852955|E1|Reported Event|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.~IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
127006|NCT01852825|B4|Baseline|Total|Total of all reporting groups
127007|NCT01852825|B3|Baseline|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
127008|NCT01852825|B2|Baseline|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
127009|NCT01852825|B1|Baseline|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
127010|NCT01852825|P3|Participant Flow|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
127091|NCT01852344|O4|Outcome|Methylphenidate Hard|Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete a hard version of the Letter E task.
127011|NCT01852825|P2|Participant Flow|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
127012|NCT01852825|P1|Participant Flow|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
127013|NCT01852825|O3|Outcome|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
127014|NCT01852825|O2|Outcome|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
127015|NCT01852825|O1|Outcome|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
127016|NCT01852825|O3|Outcome|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
127017|NCT01852825|O2|Outcome|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
127018|NCT01852825|O1|Outcome|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
127019|NCT01852825|O3|Outcome|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
127020|NCT01852825|O2|Outcome|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
127021|NCT01852825|O1|Outcome|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
127022|NCT01852825|O3|Outcome|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
127023|NCT01852825|O2|Outcome|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
127024|NCT01852825|O1|Outcome|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
127025|NCT01852825|O3|Outcome|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
127026|NCT01852825|O2|Outcome|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
127027|NCT01852825|O1|Outcome|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
127028|NCT01852825|O3|Outcome|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
127029|NCT01852825|O2|Outcome|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
127030|NCT01852825|O1|Outcome|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
127031|NCT01852825|E3|Reported Event|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
127032|NCT01852825|E2|Reported Event|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
127033|NCT01852825|E1|Reported Event|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
127034|NCT01852812|B4|Baseline|Total|Total of all reporting groups
127035|NCT01852812|B3|Baseline|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
127600|NCT01849458|O1|Outcome|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
127040|NCT01852812|P1|Participant Flow|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg oral granules (OG) in one sachet orally (PO) once daily (QD) at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
127041|NCT01852812|O3|Outcome|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
127042|NCT01852812|O2|Outcome|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
127043|NCT01852812|O1|Outcome|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
127044|NCT01852812|O3|Outcome|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
127045|NCT01852812|O2|Outcome|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
127046|NCT01852812|O1|Outcome|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
127047|NCT01852812|O3|Outcome|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
127048|NCT01852812|O2|Outcome|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
127049|NCT01852812|O1|Outcome|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
127050|NCT01852812|O3|Outcome|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
127051|NCT01852812|O2|Outcome|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
127052|NCT01852812|O1|Outcome|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
127053|NCT01852812|O2|Outcome|Montelukast 5 mg CT/6-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
127054|NCT01852812|O1|Outcome|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
127055|NCT01852812|O2|Outcome|Montelukast 5 mg CT/6-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
127056|NCT01852812|O1|Outcome|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
127057|NCT01852812|E2|Reported Event|Montelukast 5 mg CT/6-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
127058|NCT01852812|E1|Reported Event|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
127059|NCT01852669|B3|Baseline|Total|Total of all reporting groups
127060|NCT01852669|B2|Baseline|ESWL, Hydration|"ESWL with hydration~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
127061|NCT01852669|B1|Baseline|Inversion, Hydration, ESWL|"ESWL with hydration and inversion~Inversion: Patients inverted 30 degree head down in Trendelenburg position~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
127062|NCT01852669|P2|Participant Flow|ESWL, Hydration|"ESWL with hydration~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
127063|NCT01852669|P1|Participant Flow|Inversion, Hydration, ESWL|"ESWL with hydration and inversion~Inversion: Patients inverted 30 degree head down in Trendelenburg position~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
127064|NCT01852669|O2|Outcome|ESWL, Hydration|"ESWL with hydration~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
127065|NCT01852669|O1|Outcome|Inversion, Hydration, ESWL|"ESWL with hydration and inversion~Inversion: Patients inverted 30 degree head down in Trendelenburg position~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
127066|NCT01852669|E2|Reported Event|ESWL, Hydration|"ESWL with hydration~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
127067|NCT01852669|E1|Reported Event|Inversion, Hydration, ESWL|"ESWL with hydration and inversion~Inversion: Patients inverted 30 degree head down in Trendelenburg position~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
127068|NCT01852591|B1|Baseline|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
127069|NCT01852591|P1|Participant Flow|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
127070|NCT01852591|O1|Outcome|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
127071|NCT01852591|O1|Outcome|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
127072|NCT01852591|O1|Outcome|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
127073|NCT01852591|O1|Outcome|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
127074|NCT01852591|E1|Reported Event|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
127092|NCT01852344|O3|Outcome|Methylphenidate Easy|Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete an easy version of the Letter E task.
127075|NCT01852383|B1|Baseline|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.~At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication.~Administration will be as a single a.m. dose."
127076|NCT01852383|P1|Participant Flow|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.~At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication.~Administration will be as a single a.m. dose."
127077|NCT01852383|O1|Outcome|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.~At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects.~Administration was as a single a.m. dose.~Duloxetine: Patients were evaluated weekly for the first 6 weeks and every two weeks for the next 6 weeks. At 0, 1, 4, 8, and 12 weeks, the study psychiatrist completed the Cornell Dysthymia Rating Scale, Clinical Global Impression (CGI) scale, and side effect ratings using the Treatment Emergent Symptom Scale."
127078|NCT01852383|O1|Outcome|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.~At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects.~Administration was as a single a.m. dose.~Duloxetine: Patients were evaluated weekly for the first 6 weeks and every two weeks for the next 6 weeks. At 0, 1, 4, 8, and 12 weeks, the study psychiatrist completed the Cornell Dysthymia Rating Scale, Clinical Global Impression (CGI) scale, and side effect ratings using the Treatment Emergent Symptom Scale."
127079|NCT01852383|O1|Outcome|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.~At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication.~Administration will be as a single a.m. dose."
127080|NCT01852383|O1|Outcome|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.~At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication.~Administration will be as a single a.m. dose."
127081|NCT01852383|E1|Reported Event|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.~At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication.~Administration will be as a single a.m. dose."
127082|NCT01852344|B5|Baseline|Total|Total of all reporting groups
127083|NCT01852344|B4|Baseline|Methylphenidate Hard|Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete a hard version of the Letter E task.
127084|NCT01852344|B3|Baseline|Methylphenidate Easy|Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete an easy version of the Letter E task.
127085|NCT01852344|B2|Baseline|Placebo Hard|Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete a hard version of the Letter E task.
127086|NCT01852344|B1|Baseline|Placebo Easy|Healthy participants are given a placebo (sugar pill) one hour before task performance and complete an easy version of the Letter E task.
127087|NCT01852344|P4|Participant Flow|Methylphenidate Hard|Healthy participants are given 20 mgs of methylphenidate one hour before task performance and complete a hard version of the Letter E task.
127088|NCT01852344|P3|Participant Flow|Methylphenidate Easy|Participants are given 20 mgs of methylphenidate one hour before task performance and complete an easy version of the Letter E task.
127089|NCT01852344|P2|Participant Flow|Placebo Hard|Healthy participants are given a placebo (sugar pill) one hour before task performance and complete a hard version of the Letter E task.
127090|NCT01852344|P1|Participant Flow|Placebo Easy|Healthy participants are given a placebo (sugar pill) one hour before task performance and complete an easy version of the Letter E task.
127140|NCT01852162|O2|Outcome|Placebo|Placebo tablets
127141|NCT01852162|O1|Outcome|Dabigatran|Dabigatran 150mg
127093|NCT01852344|O2|Outcome|Placebo Hard|Healthy participants are given a placebo (sugar pill) one hour before task performance and complete a hard version of the Letter E task.
127094|NCT01852344|O1|Outcome|Placebo Easy|Healthy participants are given a placebo (sugar pill) one hour before task performance and complete an easy version of the Letter E task.
127095|NCT01852344|O4|Outcome|Methylphenidate Hard|Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete a hard version of the Letter E task.
127096|NCT01852344|O3|Outcome|Methylphenidate Easy|Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete an easy version of the Letter E task.
127097|NCT01852344|O2|Outcome|Placebo Hard|Healthy participants are given a placebo (sugar pill) one hour before task performance and complete a hard version of the Letter E task.
127098|NCT01852344|O1|Outcome|Placebo Easy|Healthy participants are given a placebo (sugar pill) one hour before task performance and complete and easy version of the Letter E task.
127099|NCT01852344|O4|Outcome|Methylphenidate Hard|Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete a hard version of the Letter E task.
127100|NCT01852344|O3|Outcome|Methylphenidate Easy|Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete an easy version of the Letter E task.
127101|NCT01852344|O2|Outcome|Placebo Hard|Healthy participants are given a placebo (sugar pill) one hour before task performance and complete a hard version of the Letter E task.
127102|NCT01852344|O1|Outcome|Placebo Easy|Healthy participants are given a placebo (sugar pill) one hour before task performance and complete an easy version of the Letter E task.
127103|NCT01852344|E4|Reported Event|Methylphenidate Hard|Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete a hard version of the Letter E task.
127104|NCT01852344|E3|Reported Event|Methylphenidate Easy|Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete an easy version of the Letter E task.
127105|NCT01852344|E2|Reported Event|Placebo Hard|Healthy participants are given a placebo (sugar pill) one hour before task performance and complete a hard version of the Letter E task.
127106|NCT01852344|E1|Reported Event|Placebo Easy|Healthy participants are given a placebo (sugar pill) one hour before task performance and complete an easy version of the Letter E task.
127107|NCT01852214|B1|Baseline|Overall Population|Subjects with type 2 diabetes mellitus and coronary artery disease
127108|NCT01852214|P2|Participant Flow|Ticagrelor First, Then Prasugrel|"Ticagrelor: Patients randomized to ticagrelor will be treated with a 180mg loading dose and 90mg bid maintenance dose~Prasugrel: Patients randomized to prasugrel will be treated with 60mg loading dose and 10mg maintenance dose"
127109|NCT01852214|P1|Participant Flow|Prasugrel First, Then Ticagrelor|"Prasugrel: Patients randomized to prasugrel will be treated with 60mg loading dose and 10mg maintenance dose~Ticagrelor: Patients randomized to ticagrelor will be treated with a 180mg loading dose and 90mg bid maintenance dose"
127110|NCT01852214|O2|Outcome|Ticagrelor|Patients received 180mg loading dose and 90mg bid maintenance dose
127111|NCT01852214|O1|Outcome|Prasugrel|Patients received 60mg loading dose and 10mg maintenance dose
127112|NCT01852214|O2|Outcome|Ticagrelor|Patients received 180mg loading dose and 90mg bid maintenance dose
127113|NCT01852214|O1|Outcome|Prasugrel|Patients received 60mg loading dose and 10mg maintenance dose
127114|NCT01852214|O2|Outcome|Ticagrelor|Patients received 180mg loading dose and 90mg bid maintenance dose
127115|NCT01852214|O1|Outcome|Prasugrel|Patients received 60mg loading dose and 10mg maintenance dose
127116|NCT01852214|O2|Outcome|Ticagrelor|Patients received a 180mg loading dose and 90mg bid maintenance dose
127117|NCT01852214|O1|Outcome|Prasugrel|Patients received 60mg loading dose and 10mg maintenance dose
127118|NCT01852214|E2|Reported Event|Safety Population: Patients Receiving Ticagrelor|Safety analyses were conducted on the safety population, which included all patients exposed to at least one dose of the study drug, and are reported according to the intervention received at the time the adverse event occurred.
127119|NCT01852214|E1|Reported Event|Safety Population: Patients Receiving Prasugrel|Safety analyses were conducted on the safety population, which included all patients exposed to at least one dose of the study drug, and are reported according to the intervention received at the time the adverse event occurred.
127120|NCT01852175|B3|Baseline|Total|Total of all reporting groups
127121|NCT01852175|B2|Baseline|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
127122|NCT01852175|B1|Baseline|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
127123|NCT01852175|P2|Participant Flow|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
127124|NCT01852175|P1|Participant Flow|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
127125|NCT01852175|O2|Outcome|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
127126|NCT01852175|O1|Outcome|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
127127|NCT01852175|O2|Outcome|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
127128|NCT01852175|O1|Outcome|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
127129|NCT01852175|O2|Outcome|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
127130|NCT01852175|O1|Outcome|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
127131|NCT01852175|E2|Reported Event|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
127132|NCT01852175|E1|Reported Event|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
127133|NCT01852162|B3|Baseline|Total|Total of all reporting groups
127134|NCT01852162|B2|Baseline|Placebo|Placebo tablets
127135|NCT01852162|B1|Baseline|Dabigatran|Dabigatran 150mg tablets
127136|NCT01852162|P2|Participant Flow|Placebo|Patients randomized to the placebo arm received matching placebo tablets twice/daily for 7 (±3) days.
127137|NCT01852162|P1|Participant Flow|Dabigatran|Patients randomized to the dabigatran arm received dabigatran 150mg twice/daily for 7 (±3) days.
127138|NCT01852162|O2|Outcome|Placebo|Placebo tablets
127139|NCT01852162|O1|Outcome|Dabigatran|Dabigatran 150mg
127152|NCT01852110|B1|Baseline|MK-7622 High Dose - 45 mg (Stage 1)|Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
127153|NCT01852110|P6|Participant Flow|Placebo (Stage 2)|Matching placebo to MK-7622 capsule once daily, taken orally.
127154|NCT01852110|P5|Participant Flow|MK-7622 High Dose - 45 mg (Stage 2)|Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
127155|NCT01852110|P4|Participant Flow|MK-7622 Mid Dose - 15 mg (Stage 2)|Single 15 mg MK-7622 capsule once daily, taken orally.
127156|NCT01852110|P3|Participant Flow|MK-7622 Low Dose - 5 mg (Stage 2)|Single 5 mg MK-7622 capsule once daily, taken orally.
127157|NCT01852110|P2|Participant Flow|Placebo (Stage 1)|Matching placebo to MK-7622 capsule once daily, taken orally.
127158|NCT01852110|P1|Participant Flow|MK-7622 High Dose - 45 mg (Stage 1)|Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
127159|NCT01852110|O3|Outcome|Placebo (Stage 2)|Matching placebo to MK-7622 capsule once daily, taken orally.
127160|NCT01852110|O2|Outcome|MK-7622 High Dose - 45 mg (Stage 2)|Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
127161|NCT01852110|O1|Outcome|MK-7622 Mid Dose - 15 mg (Stage 2)|Single 15 mg MK-7622 capsule once daily, taken orally.
127162|NCT01852110|O2|Outcome|Placebo (Stage 1)|Matching placebo to MK-7622 capsule once daily, taken orally.
127163|NCT01852110|O1|Outcome|MK-7622 High Dose - 45 mg (Stage 1)|Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
127164|NCT01852110|O2|Outcome|Placebo (Stage 1)|Matching placebo to MK-7622 capsule once daily, taken orally.
127165|NCT01852110|O1|Outcome|MK-7622 High Dose - 45 mg (Stage 1)|Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
127166|NCT01852110|O6|Outcome|Placebo (Stage 2)|Matching placebo to MK-7622 capsule once daily, taken orally.
127167|NCT01852110|O5|Outcome|MK-7622 High Dose - 45 mg (Stage 2)|Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
127168|NCT01852110|O4|Outcome|MK-7622 Mid Dose - 15 mg (Stage 2)|Single 15 mg MK-7622 capsule once daily, taken orally.
127169|NCT01852110|O3|Outcome|MK-7622 Low Dose - 5 mg (Stage 2)|Single 5 mg MK-7622 capsule once daily, taken orally, for 24 weeks
127170|NCT01852110|O2|Outcome|Placebo (Stage 1)|Matching placebo to MK-7622 capsule once daily, taken orally.
127171|NCT01852110|O1|Outcome|MK-7622 High Dose - 45 mg (Stage 1)|Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
127172|NCT01852110|O6|Outcome|Placebo (Stage 2)|Matching placebo to MK-7622 capsule once daily, taken orally.
127173|NCT01852110|O5|Outcome|MK-7622 High Dose - 45 mg (Stage 2)|Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
127174|NCT01852110|O4|Outcome|MK-7622 Mid Dose - 15 mg (Stage 2)|Single 15 mg MK-7622 capsule once daily, taken orally.
127175|NCT01852110|O3|Outcome|MK-7622 Low Dose - 5 mg (Stage 2)|Single 5 mg MK-7622 capsule once daily, taken orally.
127176|NCT01852110|O2|Outcome|Placebo (Stage 1)|Matching placebo to MK-7622 capsule once daily, taken orally.
127177|NCT01852110|O1|Outcome|MK-7622 High Dose - 45 mg (Stage 1)|Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
127178|NCT01852110|O3|Outcome|Placebo (Stage 2)|Matching placebo to MK-7622 capsule once daily, taken orally.
127179|NCT01852110|O2|Outcome|MK-7622 High Dose - 45 mg (Stage 2)|Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
127180|NCT01852110|O1|Outcome|MK-7622 Mid Dose - 15 mg (Stage 2)|Single 15 mg MK-7622 capsule once daily, taken orally.
127181|NCT01852110|O2|Outcome|Placebo (Stage 1)|Matching placebo to MK-7622 capsule once daily, taken orally.
127182|NCT01852110|O1|Outcome|MK-7622 High Dose - 45 mg (Stage 1)|Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
127183|NCT01852110|E2|Reported Event|Placebo (Stage 1)|Matching placebo to MK-7622 capsule once daily, taken orally.
127184|NCT01852110|E1|Reported Event|MK-7622 High Dose - 45 mg (Stage 1)|Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
127185|NCT01852032|B1|Baseline|Breast Cancer Patients|Tomosynthesis Breast Scanning is done and breast CT Scanning is done.
127186|NCT01852032|P1|Participant Flow|Breast Cancer Patients|Tomosynthesis Breast Scanning is done and breast CT Scanning is done.
127187|NCT01852032|O1|Outcome|Breast Cancer Patients|Tomosynthesis Breast Scanning is done and breast CT Scanning is done.
127188|NCT01852032|O1|Outcome|Breast Cancer Patients|Tomosynthesis Breast Scanning is done and breast CT Scanning is done.
127189|NCT01852032|O1|Outcome|Breast Cancer Patients|Tomosynthesis Breast Scanning is done and breast CT Scanning is done.
127190|NCT01852032|O1|Outcome|Breast Cancer Patients|Tomosynthesis Breast Scanning is done and breast CT Scanning is done.
127191|NCT01852032|O1|Outcome|Breast Cancer Patients|Tomosynthesis Breast Scanning is done and breast CT Scanning is done.
127192|NCT01852032|E1|Reported Event|Breast Cancer Patients|Tomosynthesis Breast Scanning is done and breast CT Scanning is done.
127193|NCT01852019|B3|Baseline|Total|Total of all reporting groups
127194|NCT01852019|B2|Baseline|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel discontinued 48h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
127195|NCT01852019|B1|Baseline|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel discontinued 24h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
127196|NCT01852019|P5|Participant Flow|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel discontinued 24h prior to initiation of cangrelor infusion (2h)~cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
127197|NCT01852019|P4|Participant Flow|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel discontinued 48h (n=6) prior to initiation of cangrelor infusion (2h)~cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
127198|NCT01852019|P3|Participant Flow|Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h|"Cangrelor IV + oral prasugrel (60mg) administered at 1.5h after the cangrelor infusion start time.~cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
127199|NCT01852019|P2|Participant Flow|Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h|"Cangrelor IV + oral prasugrel (60mg) administered at 1.0h after the cangrelor infusion start time.~cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
127200|NCT01852019|P1|Participant Flow|Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion|"Cangrelor IV + Oral prasugrel (60mg) administered within 5 minutes after cangrelor IV discontinuation~cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
127201|NCT01852019|O2|Outcome|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel was discontinued 48h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
127202|NCT01852019|O1|Outcome|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel was discontinued 24h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
127203|NCT01852019|O2|Outcome|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel was discontinued 48h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV iwas administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
127204|NCT01852019|O1|Outcome|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel was discontinued 24h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
127205|NCT01852019|O3|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h|"Cangrelor IV + oral prasugrel (60mg) were administered at 1.0h after the cangrelor infusion start time.~cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
150378|NCT01746511|B3|Baseline|Total|Total of all reporting groups
127206|NCT01852019|O2|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h|"Cangrelor IV + oral prasugrel (60mg) was administered at 1.5h after the cangrelor infusion start time.~cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
127207|NCT01852019|O1|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h)|"Cangrelor IV + Oral prasugrel (60mg) were administered within 5 minutes after cangrelor IV discontinuation~cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
127208|NCT01852019|O2|Outcome|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel was discontinued 48h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV iwas administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
127209|NCT01852019|O1|Outcome|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel was discontinued 24h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
127210|NCT01852019|O3|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h|"Cangrelor IV + oral prasugrel (60mg) were administered at 1.0h after the cangrelor infusion start time.~cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
127211|NCT01852019|O2|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h|"Cangrelor IV + oral prasugrel (60mg) was administered at 1.5h after the cangrelor infusion start time.~cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
127212|NCT01852019|O1|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h)|"Cangrelor IV + Oral prasugrel (60mg) were administered within 5 minutes after cangrelor IV discontinuation~cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
127213|NCT01852019|E5|Reported Event|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel was discontinued 48h prior to initiation of cangrelor infusion (2h)~Subjects were given 5 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.~Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8"
127214|NCT01852019|E4|Reported Event|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel was discontinued 24h prior to initiation of cangrelor infusion (2h)~Subjects were given 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.~Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8"
127215|NCT01852019|E3|Reported Event|Day 1 - Prasugrel (60mg) - Post Infusion (2.0 hr)|"Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) post infusion, [at 2.0 hrs, (within 5 minutes of discontinuing the cangrelor infusion)]."
127216|NCT01852019|E2|Reported Event|Day 1 - Prasugrel (60mg) at 1.0 hr|"Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) during the initial cangrelor infusion (at 1.0 hour after infusion start)."
127217|NCT01852019|E1|Reported Event|Day 1 - Prasugrel (60mg) at 1.5 Hrs|"Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) during the initial cangrelor infusion (at 1.5 hours after infusion start)."
127218|NCT01851876|B3|Baseline|Total|Total of all reporting groups
127219|NCT01851876|B2|Baseline|No Endometrial Injury|The patients in this group will not be subjected to endometrial injury procedure in presiding IVF cycle. The patients will be stimulated with standard IVF protocol.
127220|NCT01851876|B1|Baseline|Endometrial Injury|The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
127221|NCT01851876|P2|Participant Flow|No Endometrial Injury|The patients in this group will not be subjected to endometrial injury procedure in presiding IVF cycle. The patients will be stimulated with standard IVF protocol.
127222|NCT01851876|P1|Participant Flow|Endometrial Injury|The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
127223|NCT01851876|O2|Outcome|No Endometrial Injury|The patients in this group will not be subjected to endometrial injury procedure in presiding IVF cycle. The patients will be stimulated with standard IVF protocol.
127224|NCT01851876|O1|Outcome|Endometrial Injury|The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
127507|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
127225|NCT01851876|E2|Reported Event|No Endometrial Injury|The patients in this group will not be subjected to endometrial injury procedure in presiding IVF cycle. The patients will be stimulated with standard IVF protocol.
127226|NCT01851876|E1|Reported Event|Endometrial Injury|The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
127227|NCT01851863|B5|Baseline|Total|Total of all reporting groups
127228|NCT01851863|B4|Baseline|Proton Pump Inhibitor|"Prescribe Omeprazole.~Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
127229|NCT01851863|B3|Baseline|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
127230|NCT01851863|B2|Baseline|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
127231|NCT01851863|B1|Baseline|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
127232|NCT01851863|P4|Participant Flow|Proton Pump Inhibitor|"Prescribe Omeprazole.~Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
127233|NCT01851863|P3|Participant Flow|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
127234|NCT01851863|P2|Participant Flow|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
127235|NCT01851863|P1|Participant Flow|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
127236|NCT01851863|O4|Outcome|Proton Pump Inhibitor|"Prescribe Omeprazole.~Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
127237|NCT01851863|O3|Outcome|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
127238|NCT01851863|O2|Outcome|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
127239|NCT01851863|O1|Outcome|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
127240|NCT01851863|O4|Outcome|Proton Pump Inhibitor|"Prescribe Omeprazole.~Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
127241|NCT01851863|O3|Outcome|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
127242|NCT01851863|O2|Outcome|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
127243|NCT01851863|O1|Outcome|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
127244|NCT01851863|O4|Outcome|Proton Pump Inhibitor|"Prescribe Omeprazole.~Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
127245|NCT01851863|O3|Outcome|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
127246|NCT01851863|O2|Outcome|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
127322|NCT01851330|P1|Participant Flow|LDV/SOF 8 Week|Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet once daily for 8 weeks
156496|NCT01722994|B3|Baseline|Total|Total of all reporting groups
127247|NCT01851863|O1|Outcome|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole) .The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
127248|NCT01851863|O3|Outcome|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
127249|NCT01851863|O2|Outcome|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
127250|NCT01851863|O1|Outcome|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
127251|NCT01851863|E4|Reported Event|Proton Pump Inhibitor|"Prescribe Omeprazole.~Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
127252|NCT01851863|E3|Reported Event|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
127253|NCT01851863|E2|Reported Event|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
127254|NCT01851863|E1|Reported Event|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
127255|NCT01851772|B1|Baseline|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
127256|NCT01851772|P1|Participant Flow|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
127257|NCT01851772|O1|Outcome|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
127258|NCT01851772|O1|Outcome|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
127259|NCT01851772|O1|Outcome|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
127260|NCT01851772|E1|Reported Event|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
127261|NCT01851720|B3|Baseline|Total|Total of all reporting groups
127262|NCT01851720|B2|Baseline|Low Dose IV Fentanyl PCA|"Initially: 10 mcg demand dose every 12 minutes~No initial bolus and no continuous infusion~Demand dose increased 10 mcg every 12 minutes if necessary~Maximum dose of 100 mcg/hr~Low dose fentanyl PCA"
127263|NCT01851720|B1|Baseline|Control Group / Standard of Care|"IV fentanyl bolus 25-50 mcg every 1-2 hrs as needed for pain~(Bolus dose can be titrated up in 25 mcg increments if necessary)~Maximum dose of 100 mcg/hr~Standard IV fentanyl bolus"
127264|NCT01851720|P2|Participant Flow|Low Dose IV Fentanyl Patient Controlled Analgesia (PCA)|"Initially: 10 mcg demand dose every 12 minutes~No initial bolus and no continuous infusion~Demand dose increased 10 mcg every 12 minutes if necessary~Maximum dose of 100 mcg/hr~Low dose fentanyl PCA"
127265|NCT01851720|P1|Participant Flow|Control Group / Standard of Care|"IV fentanyl bolus 25-50 mcg every 1-2 hrs as needed for pain~(Bolus dose can be titrated up in 25 mcg increments if necessary)~Maximum dose of 100 mcg/hr~Standard IV fentanyl bolus"
127266|NCT01851720|O2|Outcome|Low Dose IV Fentanyl PCA|"Initially: 10 mcg demand dose every 12 minutes~No initial bolus and no continuous infusion~Demand dose increased 10 mcg every 12 minutes if necessary~Maximum dose of 100 mcg/hr~Low dose fentanyl PCA"
127267|NCT01851720|O1|Outcome|Control Group / Standard of Care|"IV fentanyl bolus 25-50 mcg every 1-2 hrs as needed for pain~(Bolus dose can be titrated up in 25 mcg increments if necessary)~Maximum dose of 100 mcg/hr~Standard IV fentanyl bolus"
127268|NCT01851720|E2|Reported Event|Low Dose IV Fentanyl PCA|"Initially: 10 mcg demand dose every 12 minutes~No initial bolus and no continuous infusion~Demand dose increased 10 mcg every 12 minutes if necessary~Maximum dose of 100 mcg/hr~Low dose fentanyl PCA"
127269|NCT01851720|E1|Reported Event|Control Group / Standard of Care|"IV fentanyl bolus 25-50 mcg every 1-2 hrs as needed for pain~(Bolus dose can be titrated up in 25 mcg increments if necessary)~Maximum dose of 100 mcg/hr~Standard IV fentanyl bolus"
127270|NCT01851655|B3|Baseline|Total|Total of all reporting groups
127271|NCT01851655|B2|Baseline|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
127323|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
127324|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
127325|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
156660|NCT01721772|B3|Baseline|Total|Total of all reporting groups
127272|NCT01851655|B1|Baseline|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
127273|NCT01851655|P2|Participant Flow|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
127274|NCT01851655|P1|Participant Flow|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
127275|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
127276|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
127277|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
127278|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
127279|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
127280|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
127326|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
127327|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
127328|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
127329|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
127281|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
127282|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
127283|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
127284|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
127285|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
127286|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
127287|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
127288|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
127289|NCT01851655|E2|Reported Event|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
127330|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
127331|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
127332|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
127333|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
127290|NCT01851655|E1|Reported Event|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
127291|NCT01851590|B4|Baseline|Total|Total of all reporting groups
127292|NCT01851590|B3|Baseline|Terbinafine Arm|"Oral medication with 250 mg Terbinafine / day~Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
127293|NCT01851590|B2|Baseline|Amorolfine Lacquer Arm|"Topical treatment with 5 % Amorolfine Lacquer (Loceryl®)~Amorolfine Lacquer is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
127294|NCT01851590|B1|Baseline|Resin Lacquer Arm|"Topical treatment: 30 % Resin Lacquer (Abicin®)~Resin Lacquer is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
127295|NCT01851590|P3|Participant Flow|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day~Terbinafine: Terbinafine 250 mg was administered orally once a day for 3 months in toenail onychomycosis."
127296|NCT01851590|P2|Participant Flow|Amorolfine Lacquer Arm|"Topical treatment with 5 % Amorolfine Lacquer (Loceryl®)~Amorolfine: Amorolfine was administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
127297|NCT01851590|P1|Participant Flow|Resin Lacquer Arm|"Topical treatment: 30 % Resin Lacquer (Abicin®)~Resin Lacquer was administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
127298|NCT01851590|O3|Outcome|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day~Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
127299|NCT01851590|O2|Outcome|Amorolfine Lacquer Arm|"Topical treatment with 5 % amorolfine lacquer (Loceryl®)~Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
127300|NCT01851590|O1|Outcome|Resin Lacquer Arm|"Topical treatment with 30 % resin lacquer (Abicin®)~Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
127301|NCT01851590|O3|Outcome|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day~Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
127302|NCT01851590|O2|Outcome|Amorolfine Treatment Arm|"Topical treatment with 5 % amorolfine lacquer (Loceryl®)~Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
127303|NCT01851590|O1|Outcome|Resin Lacquer Arm|"Topical treatment with 30 % resin lacquer (Abicin®)~Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
127304|NCT01851590|O3|Outcome|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day~Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
127305|NCT01851590|O2|Outcome|Amorolfine Treatment Arm|"Topical treatment with 5 % amorolfine lacquer (Loceryl®)~Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
127306|NCT01851590|O1|Outcome|Resin Lacquer Arm|"Topical treatment with 30 % resin lacquer (Abicin®)~Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
127307|NCT01851590|O3|Outcome|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day~Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
127308|NCT01851590|O2|Outcome|Amorolfine Lacquer Arm|"Topical treatment with 5 % amorolfine lacquer (Loceryl®)~Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
127309|NCT01851590|O1|Outcome|Resin Lacquer Arm|"Topical treatment with 30 % resin lacquer (Abicin®)~Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
127310|NCT01851590|O3|Outcome|Terbinafine Arm|"Oral medication with 250 mg Terbinafine / day~Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
127311|NCT01851590|O2|Outcome|Amorolfine Lacquer Arm|"Topical treatment with 5 % Amorolfine Lacquer (Loceryl®)~Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
127312|NCT01851590|O1|Outcome|Resin Lacquer Arm|"Topical treatment with 30 % Resin Lacquer (Abicin®)~Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
127313|NCT01851590|E3|Reported Event|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day~Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
127314|NCT01851590|E2|Reported Event|Amorolfine Lacquer Arm|"Topical treatment with 5 % amorolfine lacquer (Loceryl®)~Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
127315|NCT01851590|E1|Reported Event|Resin Lacquer Arm|"Topical treatment with 30 % resin lacquer (Abicin®)~Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
127316|NCT01851330|B4|Baseline|Total|Total of all reporting groups
127317|NCT01851330|B3|Baseline|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
127318|NCT01851330|B2|Baseline|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
127319|NCT01851330|B1|Baseline|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
127320|NCT01851330|P3|Participant Flow|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
127321|NCT01851330|P2|Participant Flow|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 8 weeks
127336|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
127337|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
127338|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
127339|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
127340|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
127341|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
127342|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
127343|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
127344|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
127345|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
127346|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
127347|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
127348|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
127349|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
127350|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
127351|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
127352|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
127353|NCT01851330|E3|Reported Event|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
127354|NCT01851330|E2|Reported Event|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
127355|NCT01851330|E1|Reported Event|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
127356|NCT01851174|B1|Baseline|Gemcitabine and Nab-Paclitaxel|"Gemcitabine (1,000 mg/m^2) administered intravenously on days 1 and 15, every 28 days~nab-Paclitaxel (125 mg/m^2) administered intravenously on days 1 and 15, every 28 days~Gemcitabine: Patients will receive Gemcitabine (1,000 mg/m^2) IV over 30 minutes after nab-paclitaxel infusion~nab-Paclitaxel: Patients will receive nab-Paclitaxel (125 mg/m^2) IV over 30 minutes before Gemcitabine infusion"
127357|NCT01851174|P1|Participant Flow|Gemcitabine and Nab-Paclitaxel|"Gemcitabine (1,000 mg/m^2) administered intravenously on days 1 and 15, every 28 days~nab-Paclitaxel (125 mg/m^2) administered intravenously on days 1 and 15, every 28 days~Gemcitabine: Patients will receive Gemcitabine (1,000 mg/m^2) IV over 30 minutes after nab-paclitaxel infusion~nab-Paclitaxel: Patients will receive nab-Paclitaxel (125 mg/m^2) IV over 30 minutes before Gemcitabine infusion"
127358|NCT01851174|O1|Outcome|Gemcitabine and Nab-Paclitaxel|"Gemcitabine (1,000 mg/m^2) administered intravenously on days 1 and 15, every 28 days~nab-Paclitaxel (125 mg/m^2) administered intravenously on days 1 and 15, every 28 days~Gemcitabine: Patients will receive Gemcitabine (1,000 mg/m^2) IV over 30 minutes after nab-paclitaxel infusion~nab-Paclitaxel: Patients will receive nab-Paclitaxel (125 mg/m^2) IV over 30 minutes before Gemcitabine infusion"
127359|NCT01851174|O1|Outcome|Gemcitabine and Nab-Paclitaxel|"Gemcitabine (1,000 mg/m^2) administered intravenously on days 1 and 15, every 28 days~nab-Paclitaxel (125 mg/m^2) administered intravenously on days 1 and 15, every 28 days~Gemcitabine: Patients will receive Gemcitabine (1,000 mg/m^2) IV over 30 minutes after nab-paclitaxel infusion~nab-Paclitaxel: Patients will receive nab-Paclitaxel (125 mg/m^2) IV over 30 minutes before Gemcitabine infusion"
127360|NCT01851174|E1|Reported Event|Gemcitabine and Nab-Paclitaxel|"Gemcitabine (1,000 mg/m^2) administered intravenously on days 1 and 15, every 28 days~nab-Paclitaxel (125 mg/m^2) administered intravenously on days 1 and 15, every 28 days~Gemcitabine: Patients will receive Gemcitabine (1,000 mg/m^2) IV over 30 minutes after nab-paclitaxel infusion~nab-Paclitaxel: Patients will receive nab-Paclitaxel (125 mg/m^2) IV over 30 minutes before Gemcitabine infusion"
127361|NCT01850615|B3|Baseline|Total|Total of all reporting groups
127362|NCT01850615|B2|Baseline|Basal|During the 18-week treatment period, subjects received s.c. injection of basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different (PG) levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
127363|NCT01850615|B1|Baseline|Faster Aspart + Basal|During the 18-week treatment period, subjects received subcutaneous (s.c., under the skin) injection of faster aspart (bolus insulin) along with s.c. basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different PG levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. Faster aspart was administered 0-2 minutes before each main meal (i.e., breakfast, lunch and main evening meal). The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
127364|NCT01850615|P2|Participant Flow|Basal|During the 18-week treatment period, subjects received s.c. injection of basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different PG levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
127409|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
127365|NCT01850615|P1|Participant Flow|Faster Aspart + Basal|During the 18-week treatment period, subjects received subcutaneous (s.c., under the skin) injection of faster aspart (bolus insulin) along with s.c. basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different plasma glucose (PG) levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. Faster aspart was administered 0-2 minutes before each main meal (i.e., breakfast, lunch and main evening meal). The basal insulin injection was to be given once daily (OD), in the evening, at approximately the same time each day.
127366|NCT01850615|O2|Outcome|Basal|During the 18-week treatment period, subjects received s.c. injection of basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different (PG) levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
127367|NCT01850615|O1|Outcome|Faster Aspart + Basal|During the 18-week treatment period, subjects received subcutaneous (s.c., under the skin) injection of faster aspart (bolus insulin) along with s.c. basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different PG levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. Faster aspart was administered 0-2 minutes before each main meal (i.e., breakfast, lunch and main evening meal). The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
127368|NCT01850615|O2|Outcome|Basal|During the 18-week treatment period, subjects received s.c. injection of basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different (PG) levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
127369|NCT01850615|O1|Outcome|Faster Aspart + Basal|During the 18-week treatment period, subjects received subcutaneous (s.c., under the skin) injection of faster aspart (bolus insulin) along with s.c. basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different PG levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. Faster aspart was administered 0-2 minutes before each main meal (i.e., breakfast, lunch and main evening meal). The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
127370|NCT01850615|O2|Outcome|Basal|During the 18-week treatment period, subjects received s.c. injection of basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different (PG) levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
127371|NCT01850615|O1|Outcome|Faster Aspart + Basal|During the 18-week treatment period, subjects received subcutaneous (s.c., under the skin) injection of faster aspart (bolus insulin) along with s.c. basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different PG levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. Faster aspart was administered 0-2 minutes before each main meal (i.e., breakfast, lunch and main evening meal). The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
127372|NCT01850615|O2|Outcome|Basal|During the 18-week treatment period, subjects received s.c. injection of basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different (PG) levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
127373|NCT01850615|O1|Outcome|Faster Aspart + Basal|During the 18-week treatment period, subjects received subcutaneous (s.c., under the skin) injection of faster aspart (bolus insulin) along with s.c. basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different PG levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. Faster aspart was administered 0-2 minutes before each main meal (i.e., breakfast, lunch and main evening meal). The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
127374|NCT01850615|O2|Outcome|Basal|During the 18-week treatment period, subjects received s.c. injection of basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different (PG) levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
127386|NCT01850589|O1|Outcome|Conserative Therapy|"Patients counseled by the vascular attending/fellow during office appointment to stop smoking. Counseling consists of self-help materials including Smart Move: A Stop Smoking Guide from the American Cancer Society and a brief educational discussion on the benefits of smoking cessation. Patients randomized to Group 1 will be offered adjunctive treatment with nicotine replacement therapy at no cost."
127375|NCT01850615|O1|Outcome|Faster Aspart + Basal|During the 18-week treatment period, subjects received subcutaneous (s.c., under the skin) injection of faster aspart (bolus insulin) along with s.c. basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different PG levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. Faster aspart was administered 0-2 minutes before each main meal (i.e., breakfast, lunch and main evening meal). The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
127376|NCT01850615|O2|Outcome|Basal|During the 18-week treatment period, subjects received s.c. injection of basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different (PG) levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
127377|NCT01850615|O1|Outcome|Faster Aspart + Basal|During the 18-week treatment period, subjects received subcutaneous (s.c., under the skin) injection of faster aspart (bolus insulin) along with s.c. basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different PG levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. Faster aspart was administered 0-2 minutes before each main meal (i.e., breakfast, lunch and main evening meal). The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
127378|NCT01850615|E2|Reported Event|Basal|During the 18-week treatment period, subjects received s.c. injection of basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different (PG) levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
127379|NCT01850615|E1|Reported Event|Faster Aspart + Basal|During the 18-week treatment period, subjects received subcutaneous (s.c., under the skin) injection of faster aspart (bolus insulin) along with s.c. basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different PG levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. Faster aspart was administered 0-2 minutes before each main meal (i.e., breakfast, lunch and main evening meal). The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
127380|NCT01850589|B3|Baseline|Total|Total of all reporting groups
127381|NCT01850589|B2|Baseline|Aggressive Therapy|"8 week comprehensive smoking cessation and pharmacotherapy program consisting of:~One hour group counseling sessions, focusing on patient education and behavior modification.~Behavior modifications including recognition; coping skills; stress management; and relapse prevention skills.~Counseling including information on nutrition, exercise, and chemical dependency.~Counseling sessions will be held 256C Mason Avenue. Pharmacotherapy adjuncts offered at no cost are as follows: Chantix (varenicline) GlaxoSmithKline, Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline.~Varenicline, Bupropion,and nicotine nasal spray, inhaler, transdermal patches and gum: Pharmacotherapy adjuncts offered at no cost are as follows:~Chantix (varenicline) GlaxoSmithKline,~Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline."
127382|NCT01850589|B1|Baseline|Conserative Therapy|"Patients counseled by the vascular attending/fellow during office appointment to stop smoking. Counseling consists of self-help materials including Smart Move: A Stop Smoking Guide from the American Cancer Society and a brief educational discussion on the benefits of smoking cessation. Patients randomized to Group 1 will be offered adjunctive treatment with nicotine replacement therapy at no cost."
127383|NCT01850589|P2|Participant Flow|Aggressive Therapy|"8 week comprehensive smoking cessation and pharmacotherapy program consisting of:~8 one hour group counseling sessions focusing on patient education and behavior modification.~Behavior modifications include cue recognition; coping skills; stress management; and relapse prevention skills.~Counseling includes information on nutrition, exercise, and chemical dependency.~All counseling sessions will be held at 256C Mason Avenue. Pharmacotherapy adjuncts offered at no cost are as follows:~Chantix (varenicline) GlaxoSmithKline,~Zyban (bupropion) Pfizer~Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline."
127384|NCT01850589|P1|Participant Flow|Conserative Therapy|"Patients will be counseled by the vascular attending/fellow during their office appointment to stop smoking. Counseling will consist of a self-help materials including Smart Move: A Stop Smoking Guide from the American Cancer Society and a brief educational discussion on the benefits of smoking cessation. Patients randomized to Group 1 will be offered adjunctive treatment with nicotine replacement therapy at no cost."
127385|NCT01850589|O2|Outcome|Aggressive Therapy|"8 week comprehensive smoking cessation and pharmacotherapy program consisting of:~One hour group counseling sessions, focusing on patient education and behavior modification.~Behavior modifications including recognition; coping skills; stress management; and relapse prevention skills.~Counseling including information on nutrition, exercise, and chemical dependency.~Counseling sessions will be held 256C Mason Avenue. Pharmacotherapy adjuncts offered at no cost are as follows: Chantix (varenicline) GlaxoSmithKline, Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline.~Varenicline, Bupropion,and nicotine nasal spray, inhaler, transdermal patches and gum: Pharmacotherapy adjuncts offered at no cost are as follows:~Chantix (varenicline) GlaxoSmithKline,~Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline."
127408|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
127387|NCT01850589|E2|Reported Event|Aggressive Therapy|"8 week comprehensive smoking cessation and pharmacotherapy program consisting of:~One hour group counseling sessions, focusing on patient education and behavior modification.~Behavior modifications including recognition; coping skills; stress management; and relapse prevention skills.~Counseling including information on nutrition, exercise, and chemical dependency.~Counseling sessions will be held 256C Mason Avenue. Pharmacotherapy adjuncts offered at no cost are as follows: Chantix (varenicline) GlaxoSmithKline, Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline.~Varenicline, Bupropion,and nicotine nasal spray, inhaler, transdermal patches and gum: Pharmacotherapy adjuncts offered at no cost are as follows:~Chantix (varenicline) GlaxoSmithKline,~Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline."
127388|NCT01850589|E1|Reported Event|Conserative Therapy|"Patients counseled by the vascular attending/fellow during office appointment to stop smoking. Counseling consists of self-help materials including Smart Move: A Stop Smoking Guide from the American Cancer Society and a brief educational discussion on the benefits of smoking cessation. Patients randomized to Group 1 will be offered adjunctive treatment with nicotine replacement therapy at no cost."
127389|NCT01850550|B3|Baseline|Total|Total of all reporting groups
127390|NCT01850550|B2|Baseline|Weight Loss Groups|"Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.~Weight loss Groups: The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions."
127391|NCT01850550|B1|Baseline|Control|"Participants in the control condition will be given written information at the baseline visit from the NIH website Aim for a Healthy Weight to provide a basic understanding of weight loss and access to basic online resources, but will not participate in group weight loss sessions with peer leaders."
127392|NCT01850550|P2|Participant Flow|Weight Loss Groups|"Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.~Weight loss Groups: The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions."
127393|NCT01850550|P1|Participant Flow|Control|"Participants in the control condition will be given written information at the baseline visit from the NIH website Aim for a Healthy Weight to provide a basic understanding of weight loss and access to basic online resources, but will not participate in group weight loss sessions with peer leaders."
127394|NCT01850550|O2|Outcome|Weight Loss Groups|"Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.~Weight loss Groups: The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions."
127395|NCT01850550|O1|Outcome|Control|"Participants in the control condition will be given written information at the baseline visit from the NIH website Aim for a Healthy Weight to provide a basic understanding of weight loss and access to basic online resources, but will not participate in group weight loss sessions with peer leaders."
127396|NCT01850550|O2|Outcome|Weight Loss Groups|"Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.~Weight loss Groups: The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions."
127397|NCT01850550|O1|Outcome|Control|"Participants in the control condition will be given written information at the baseline visit from the NIH website Aim for a Healthy Weight to provide a basic understanding of weight loss and access to basic online resources, but will not participate in group weight loss sessions with peer leaders."
127398|NCT01850550|E2|Reported Event|Weight Loss Groups|"Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.~Weight loss Groups: The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions."
127399|NCT01850550|E1|Reported Event|Control|"Participants in the control condition will be given written information at the baseline visit from the NIH website Aim for a Healthy Weight to provide a basic understanding of weight loss and access to basic online resources, but will not participate in group weight loss sessions with peer leaders."
127400|NCT01850485|B3|Baseline|Total|Total of all reporting groups
127401|NCT01850485|B2|Baseline|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
127402|NCT01850485|B1|Baseline|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
127403|NCT01850485|P2|Participant Flow|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
127404|NCT01850485|P1|Participant Flow|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
127405|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
127406|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
127407|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
127410|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
127411|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
127412|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
127413|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
127414|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
127415|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
127416|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
127417|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
127418|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
127419|NCT01850485|E2|Reported Event|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
127420|NCT01850485|E1|Reported Event|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
127421|NCT01850394|B4|Baseline|Total|Total of all reporting groups
127422|NCT01850394|B3|Baseline|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
127423|NCT01850394|B2|Baseline|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
127424|NCT01850394|B1|Baseline|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
127425|NCT01850394|P3|Participant Flow|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
127426|NCT01850394|P2|Participant Flow|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
127427|NCT01850394|P1|Participant Flow|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
127428|NCT01850394|O3|Outcome|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
127429|NCT01850394|O2|Outcome|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
127430|NCT01850394|O1|Outcome|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
127431|NCT01850394|O3|Outcome|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
127432|NCT01850394|O2|Outcome|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
127433|NCT01850394|O1|Outcome|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
127434|NCT01850394|O3|Outcome|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
127435|NCT01850394|O2|Outcome|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
127436|NCT01850394|O1|Outcome|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
127437|NCT01850394|O3|Outcome|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
127505|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
127438|NCT01850394|O2|Outcome|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
127439|NCT01850394|O1|Outcome|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
127440|NCT01850394|O3|Outcome|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
127441|NCT01850394|O2|Outcome|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
127442|NCT01850394|O1|Outcome|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
127443|NCT01850394|E3|Reported Event|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
127444|NCT01850394|E2|Reported Event|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
127445|NCT01850394|E1|Reported Event|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
127446|NCT01850030|B3|Baseline|Total|Total of all reporting groups
127447|NCT01850030|B2|Baseline|Micronized Progesterone 600 mg|"Micronized Progesterone 600 mg: Intravaginal micronized progesterone 200 mg capsules tid~Placebo dydrogesterone: placebo oral dydrogesterone 10 mg tablets tid"
127448|NCT01850030|B1|Baseline|Dydrogesterone 30 mg|"Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid~Placebo progesterone: Placebo intravaginal micronized progesterone 200 mg capsules tid"
127449|NCT01850030|P2|Participant Flow|Micronized Progesterone 600 mg|"Micronized Progesterone 600 mg: Intravaginal micronized progesterone 200 mg capsules tid~Placebo dydrogesterone: placebo oral dydrogesterone 10 mg tablets tid"
127450|NCT01850030|P1|Participant Flow|Dydrogesterone 30 mg|"Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid~Placebo progesterone: Placebo intravaginal micronized progesterone 200 mg capsules tid"
127451|NCT01850030|O2|Outcome|Micronized Progesterone 600 mg|"Micronized Progesterone 600 mg: Intravaginal micronized progesterone 200 mg capsules tid~Placebo dydrogesterone: placebo oral dydrogesterone 10 mg tablets tid"
127452|NCT01850030|O1|Outcome|Dydrogesterone 30 mg|"Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid~Placebo progesterone: Placebo intravaginal micronized progesterone 200 mg capsules tid"
127453|NCT01850030|O2|Outcome|Micronized Progesterone 600 mg|"Micronized Progesterone 600 mg: Intravaginal micronized progesterone 200 mg capsules tid~Placebo dydrogesterone: placebo oral dydrogesterone 10 mg tablets tid"
127454|NCT01850030|O1|Outcome|Dydrogesterone 30 mg|"Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid~Placebo progesterone: Placebo intravaginal micronized progesterone 200 mg capsules tid"
127455|NCT01850030|O2|Outcome|Micronized Progesterone 600 mg|"Micronized Progesterone 600 mg: Intravaginal micronized progesterone 200 mg capsules tid~Placebo dydrogesterone: placebo oral dydrogesterone 10 mg tablets tid"
127456|NCT01850030|O1|Outcome|Dydrogesterone 30 mg|"Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid~Placebo progesterone: Placebo intravaginal micronized progesterone 200 mg capsules tid"
127457|NCT01850030|O2|Outcome|Micronized Progesterone 600 mg|"Micronized Progesterone 600 mg: Intravaginal micronized progesterone 200 mg capsules tid~Placebo dydrogesterone: placebo oral dydrogesterone 10 mg tablets tid"
127458|NCT01850030|O1|Outcome|Dydrogesterone 30 mg|"Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid~Placebo progesterone: Placebo intravaginal micronized progesterone 200 mg capsules tid"
127459|NCT01850030|E2|Reported Event|Micronized Progesterone 600 mg|"Micronized Progesterone 600 mg: Intravaginal micronized progesterone 200 mg capsules tid~Placebo dydrogesterone: placebo oral dydrogesterone 10 mg tablets tid"
127460|NCT01850030|E1|Reported Event|Dydrogesterone 30 mg|"Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid~Placebo progesterone: Placebo intravaginal micronized progesterone 200 mg capsules tid"
127461|NCT01849848|B1|Baseline|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
127462|NCT01849848|P1|Participant Flow|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
127463|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
127464|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
127465|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
127466|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
127467|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
127468|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
127469|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
127470|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
127471|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
127472|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
127473|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
127474|NCT01849848|E1|Reported Event|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
127475|NCT01849770|B4|Baseline|Total|Total of all reporting groups
127476|NCT01849770|B3|Baseline|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
127477|NCT01849770|B2|Baseline|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
127478|NCT01849770|B1|Baseline|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
127479|NCT01849770|P3|Participant Flow|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
127480|NCT01849770|P2|Participant Flow|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
127481|NCT01849770|P1|Participant Flow|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
127482|NCT01849770|O2|Outcome|900mg vs Placebo|
127483|NCT01849770|O1|Outcome|300mg vs Placebo|
127484|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
127485|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
127486|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
127487|NCT01849770|O2|Outcome|900mg vs Placebo|
127488|NCT01849770|O1|Outcome|300mg vs Placebo|
127489|NCT01849770|O2|Outcome|900mg vs Placebo|
127490|NCT01849770|O1|Outcome|300mg vs Placebo|
127491|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
127492|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
127493|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
127494|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
127495|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
127496|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
127497|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
127498|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
127499|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
127500|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
127501|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
127502|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
127503|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
127504|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
157734|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
127508|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
127509|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
127510|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
127511|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
127512|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
127513|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
127514|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
127515|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
127516|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
127517|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
127518|NCT01849770|E3|Reported Event|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
127519|NCT01849770|E2|Reported Event|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
127520|NCT01849770|E1|Reported Event|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
127521|NCT01849692|B3|Baseline|Total|Total of all reporting groups
127522|NCT01849692|B2|Baseline|LUCENTIS|All subjects who were treated with LUCENTIS.
127523|NCT01849692|B1|Baseline|ESBA|All subjects who were treated with ESBA1008.
127524|NCT01849692|P8|Participant Flow|Cohort 4 - Ranibizumab|Ranibizumab 0.5 mg injection, Day 0 and Day 28
127525|NCT01849692|P7|Participant Flow|Cohort 4 - ESBA|ESBA1008 solution Day 0 (0.5 mg) and Day 28 (6 mg)
127526|NCT01849692|P6|Participant Flow|Cohort 3 - Ranibizumab|Ranibizumab 0.5 mg injection, Day 0 and Day 28
127527|NCT01849692|P5|Participant Flow|Cohort 3 - ESBA|ESBA1008 solution Day 0 (0.6 mg) and Day 28 (6 mg)
127528|NCT01849692|P4|Participant Flow|Cohort 2 - Ranibizumab|Ranibizumab 0.5 mg injection, Day 0 and Day 28
127529|NCT01849692|P3|Participant Flow|Cohort 2 - ESBA|ESBA1008 solution Day 0 (1 mg) and Day 28 (6 mg)
127530|NCT01849692|P2|Participant Flow|Cohort 1 - Ranibizumab|Ranibizumab 0.5 mg injection, Day 0 and Day 28
127531|NCT01849692|P1|Participant Flow|Cohort 1 - ESBA|ESBA1008 solution Day 0 (1.2 mg) and Day 28 (6 mg)
127532|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
127533|NCT01849692|O1|Outcome|ESBA 0.5 mg INF|All subjects treated with ESBA1008 0.5 mg IVT infusion
127534|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
127535|NCT01849692|O1|Outcome|ESBA 0.6 mg INJ|All subjects treated with ESBA1008 0.6 mg IVT injection
127536|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
127537|NCT01849692|O1|Outcome|ESBA 1 mg INF|All subjects treated with ESBA1008 1 mg IVT infusion
127538|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
127539|NCT01849692|O1|Outcome|ESBA 1.2 mg INJ|All subjects treated with ESBA1008 1.2 mg IVT injection
127540|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
127541|NCT01849692|O1|Outcome|ESBA 0.5 mg INF|All subjects treated with ESBA1008 0.5 mg IVT infusion
127542|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
127543|NCT01849692|O1|Outcome|ESBA 0.6 mg INJ|All subjects treated with ESBA 1008 0.6 mg IVT injection
127544|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
127545|NCT01849692|O1|Outcome|ESBA 1 mg INF|All subjects treated with ESBA 1008 1 mg IVT infusion
127546|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
127547|NCT01849692|O1|Outcome|ESBA 1.2 mg INJ|All subjects treated with ESBA 1008 1.2 mg IVT injection
127548|NCT01849692|O4|Outcome|Cohort 4|ESBA1008 solution Day 0 (0.5 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
127549|NCT01849692|O3|Outcome|Cohort 3|ESBA1008 solution Day 0 (0.6 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
127550|NCT01849692|O2|Outcome|Cohort 2|ESBA1008 solution Day 0 (1 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
127551|NCT01849692|O1|Outcome|Cohort 1|ESBA1008 solution Day 0 (1.2 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
127552|NCT01849692|E7|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
127553|NCT01849692|E6|Reported Event|Stage 2 LUCENTIS 0.5 mg INJ|All subjects treated with LUCENTIS via injection in Stage 2
127554|NCT01849692|E5|Reported Event|Stage 2 ESBA 0.5 mg INF|All subjects treated with ESBA1008 0.5 mg via infusion
127555|NCT01849692|E4|Reported Event|Stage 2 ESBA 0.6 mg INJ|All subjects treated with ESBA1008 0.6 mg via injection
127556|NCT01849692|E3|Reported Event|Stage 1 LUCENTIS 0.5 mg INJ|All subjects treated with LUCENTIS via injection in Stage 1
127557|NCT01849692|E2|Reported Event|Stage 1 ESBA 1 mg INF|All subjects treated with ESBA1008 1 mg via infusion
127558|NCT01849692|E1|Reported Event|Stage 1 ESBA 1.2 mg INJ|All subjects treated with ESBA1008 1.2 mg via injection
127559|NCT01849588|B1|Baseline|Sorafenib|"Sorafenib taken orally twice per day~Sorafenib"
127560|NCT01849588|P1|Participant Flow|Sorafenib|"Sorafenib taken orally twice per day~Sorafenib"
127561|NCT01849588|O1|Outcome|Treatment Arm|"Sorafenib taken orally twice per day~Sorafenib"
127562|NCT01849588|O1|Outcome|Treatment Arm|"Sorafenib taken orally twice per day~Sorafenib"
127563|NCT01849588|O1|Outcome|Treatment Arm|"Sorafenib taken orally twice per day~Sorafenib"
127564|NCT01849588|O1|Outcome|Treatment Arm|"Sorafenib taken orally twice per day~Sorafenib"
127565|NCT01849588|E1|Reported Event|Sorafenib|"Sorafenib taken orally twice per day~Sorafenib"
127566|NCT01849562|B4|Baseline|Total|Total of all reporting groups
127567|NCT01849562|B3|Baseline|Placebo|"Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks~Placebo"
127568|NCT01849562|B2|Baseline|Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg|"Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
127569|NCT01849562|B1|Baseline|Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg|"Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
127570|NCT01849562|P3|Participant Flow|Placebo|"Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks~Placebo"
127571|NCT01849562|P2|Participant Flow|Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg|"Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
127572|NCT01849562|P1|Participant Flow|Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg|"Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
127573|NCT01849562|O3|Outcome|Placebo|"Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks~Placebo"
127574|NCT01849562|O2|Outcome|Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-2000mg|"Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
127575|NCT01849562|O1|Outcome|Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg|"Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
127576|NCT01849562|O3|Outcome|Placebo|"Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks~Placebo"
127577|NCT01849562|O2|Outcome|Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg|"Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
127578|NCT01849562|O1|Outcome|Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg|"Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
127579|NCT01849562|E3|Reported Event|Placebo|"Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks~Placebo"
127580|NCT01849562|E2|Reported Event|Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg|"Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
127581|NCT01849562|E1|Reported Event|Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg|"Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
127582|NCT01849497|B3|Baseline|Total|Total of all reporting groups
127583|NCT01849497|B2|Baseline|Evolocumab AI/Pen|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen).
127584|NCT01849497|B1|Baseline|Evolocumab PFS|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
127585|NCT01849497|P2|Participant Flow|Evolocumab AI/Pen|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 2 and 4.
127586|NCT01849497|P1|Participant Flow|Evolocumab PFS|"Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).~Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 2 and 4."
127587|NCT01849497|O2|Outcome|Evolocumab AI/Pen|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen).
127588|NCT01849497|O1|Outcome|Evolocumab PFS|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
127589|NCT01849497|O2|Outcome|Evolocumab AI/Pen|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen).
127590|NCT01849497|O1|Outcome|Evolocumab PFS|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
127591|NCT01849497|E2|Reported Event|Evolocumab AI/Pen|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen).
127592|NCT01849497|E1|Reported Event|Evolocumab PFS|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
127593|NCT01849458|B1|Baseline|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
127594|NCT01849458|P1|Participant Flow|BioFiber Scaffold|Single arm of subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
127595|NCT01849458|O1|Outcome|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
127596|NCT01849458|O1|Outcome|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
127597|NCT01849458|O1|Outcome|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
127598|NCT01849458|O1|Outcome|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
127599|NCT01849458|O1|Outcome|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
127601|NCT01849458|O1|Outcome|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
127602|NCT01849458|E1|Reported Event|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
127603|NCT01849419|B1|Baseline|Single Group|"Healthy volunteers received all drug conditions including placebo (within-subjects design).~Within-subjects (MDMA and placebo): This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received MDMA (0.75, 1.5 mg/kg)and placebo. Participants received oxytocin as an active control on one session (see second Intervention).~Within-subjects (oxytocin and placebo): This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received oxytocin (20 IU) on one session and placebo on one session. Participants received MDMA on the other two sessions (see first Intervention)."
127604|NCT01849419|P1|Participant Flow|Single Group|"Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.~This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received MDMA (0.75, 1.5 mg/kg), oxytocin (20 IU), and placebo over the course of four experimental sessions. Drug order was randomized for each participant."
127605|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
127606|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
127607|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
127608|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
127609|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
127610|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
127611|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
127612|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
127613|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
127614|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
127615|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
127616|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
127617|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
127618|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
127619|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
127620|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
127621|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
127622|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
127623|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
127624|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
127625|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
127626|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
127627|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
127628|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
127629|NCT01849419|E1|Reported Event|Single Group|"Healthy volunteers received all drug conditions including placebo (within-subjects design).~Within-subjects (MDMA and placebo): This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received MDMA (0.75, 1.5 mg/kg)and placebo. Participants received oxytocin as an active control on one session (see second Intervention).~Within-subjects (oxytocin and placebo): This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received oxytocin (20 IU) on one session and placebo on one session. Participants received MDMA on the other two sessions (see first Intervention)."
127630|NCT01849289|B3|Baseline|Total|Total of all reporting groups
127631|NCT01849289|B2|Baseline|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
127632|NCT01849289|B1|Baseline|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
127723|NCT01848899|B2|Baseline|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
127724|NCT01848899|B1|Baseline|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
127633|NCT01849289|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
127634|NCT01849289|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
127635|NCT01849289|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
127636|NCT01849289|O1|Outcome|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
127637|NCT01849289|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
127638|NCT01849289|O1|Outcome|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
127639|NCT01849289|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
127640|NCT01849289|O1|Outcome|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
127641|NCT01849289|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
127642|NCT01849289|O1|Outcome|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
127643|NCT01849289|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
127644|NCT01849289|O1|Outcome|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
127645|NCT01849289|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
127646|NCT01849289|O1|Outcome|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
127647|NCT01849289|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
127648|NCT01849289|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
127725|NCT01848899|P2|Participant Flow|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
157735|NCT01717989|O4|Outcome|Q3 2011|Third quarter (Q3) 2011
127649|NCT01849263|B1|Baseline|Treatment (Ibrutinib)|Patients receive 560 mg ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
127650|NCT01849263|P1|Participant Flow|Treatment (Ibrutinib)|Patients receive 560 mg ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
127651|NCT01849263|O1|Outcome|Treatment (Ibrutinib)|Patients receive 560 mg ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
127652|NCT01849263|O1|Outcome|Treatment (Ibrutinib)|Patients receive 560 mg ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
127653|NCT01849263|O1|Outcome|Treatment (Ibrutinib)|Patients receive 560 mg ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
127654|NCT01849263|O1|Outcome|Treatment (Ibrutinib)|Patients receive 560 mg ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
127655|NCT01849263|O1|Outcome|Treatment (Ibrutinib)|Patients receive 560 mg ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
127656|NCT01849263|O1|Outcome|Treatment (Ibrutinib)|Patients receive 560 mg ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
127657|NCT01849263|O1|Outcome|Treatment (Ibrutinib)|Patients receive 560 mg ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
127658|NCT01849263|E1|Reported Event|Treatment (Ibrutinib)|Patients receive 560 mg ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
127659|NCT01849068|B3|Baseline|Total|Total of all reporting groups
127660|NCT01849068|B2|Baseline|Placebo First Then Ezetimibe|First intervention: Placebo for 12 weeks Second intervention: Ezetimibe 12 weeks
127661|NCT01849068|B1|Baseline|Ezetimibe First Then Placebo|First intervention: Ezetimibe 10 mg/d for 12 weeks Second intervention: Placebo 12 weeks
127662|NCT01849068|P2|Participant Flow|Placebo First, Then Ezetimibe|First intervention: Placebo for 12 weeks Second intervention: Ezetimibe 10 mg/d for 12 weeks
127663|NCT01849068|P1|Participant Flow|Ezetimibe First, Then Placebo|First intervention: Ezetimibe 10 mg/d for 12 weeks Second intervention: Placebo for 12 weeks
127664|NCT01849068|O2|Outcome|Placebo|Placebo: Placebo for 12 weeks Placebo for 12 weeks
127665|NCT01849068|O1|Outcome|Ezetimibe|Ezetimibe: Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
127666|NCT01849068|O2|Outcome|Placebo|Placebo: Placebo for 12 weeks Placebo for 12 weeks
127667|NCT01849068|O1|Outcome|Ezetimibe|Ezetimibe: Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
127668|NCT01849068|O2|Outcome|Placebo|Placebo: Placebo for 12 weeks Placebo for 12 weeks
127669|NCT01849068|O1|Outcome|Ezetimibe|Ezetimibe: Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
127670|NCT01849068|O2|Outcome|Placebo|Placebo: Placebo for 12 weeks Placebo for 12 weeks
127671|NCT01849068|O1|Outcome|Ezetimibe|Ezetimibe: Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
127672|NCT01849068|E2|Reported Event|Placebo|Placebo for 12 weeks Placebo for 12 weeks
127673|NCT01849068|E1|Reported Event|Ezetimibe|Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
127674|NCT01848990|B4|Baseline|Total|Total of all reporting groups
127675|NCT01848990|B3|Baseline|Standard Rapid-Acting Insulin CSII|Participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
127676|NCT01848990|B2|Baseline|Precommercial Hylenex Recombinant (Formulation 2)|Hylenex Formulation 2: For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the precommercial form of Hylenex recombinant, delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
127677|NCT01848990|B1|Baseline|Commercial Hylenex Recombinant (Formulation 1)|Hylenex Formulation 1: For 6 months, participants received their regular treatment of rapid-acting continuous CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the commercial form of Hylenex recombinant, delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
127678|NCT01848990|P3|Participant Flow|Standard Rapid-Acting Insulin CSII|Participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
127726|NCT01848899|P1|Participant Flow|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
127727|NCT01848899|O2|Outcome|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
127728|NCT01848899|O1|Outcome|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
127679|NCT01848990|P2|Participant Flow|Precommercial Hylenex Recombinant (Formulation 2)|Hylenex Formulation 2: For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the precommercial form of Hylenex recombinant, delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
127680|NCT01848990|P1|Participant Flow|Commercial Hylenex Recombinant (Formulation 1)|Hylenex Formulation 1: For 6 months, participants received their regular treatment of rapid-acting continuous subcutaneous insulin infusion (CSII) (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the commercial form of Hylenex recombinant, delivered at 150 units (U) through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
127681|NCT01848990|O2|Outcome|Standard Rapid-acting Insulin CSII|Participants received their regular treatment of rapid-acting insulin CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
127682|NCT01848990|O1|Outcome|Hylenex Recombinant|For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of Hylenex recombinant (either Formulation 1 or Formulation 2), delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
127683|NCT01848990|O2|Outcome|Standard Rapid-acting Insulin CSII|Participants received their regular treatment of rapid-acting insulin CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
127684|NCT01848990|O1|Outcome|Hylenex Recombinant|For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of Hylenex recombinant (either Formulation 1 or Formulation 2), delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
127685|NCT01848990|O2|Outcome|Standard Rapid-acting Insulin CSII|Participants received their regular treatment of rapid-acting insulin CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
127686|NCT01848990|O1|Outcome|Hylenex Recombinant|For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of Hylenex recombinant (either Formulation 1 or Formulation 2), delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
127687|NCT01848990|O2|Outcome|Standard Rapid-acting Insulin CSII|Participants received their regular treatment of rapid-acting insulin CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
127688|NCT01848990|O1|Outcome|Hylenex Recombinant|For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of Hylenex recombinant (either Formulation 1 or Formulation 2), delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
127689|NCT01848990|O2|Outcome|Standard Rapid-Acting Insulin CSII|Participants received their regular treatment of rapid-acting insulin CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
127690|NCT01848990|O1|Outcome|Hylenex Recombinant|For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of Hylenex recombinant (either Formulation 1 or Formulation 2), delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
127691|NCT01848990|E3|Reported Event|Standard Rapid-Acting Insulin CSII|Participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
127692|NCT01848990|E2|Reported Event|Precommercial Hylenex Recombinant (Formulation 2)|Hylenex Formulation 2: For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the precommercial form of Hylenex recombinant, delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
127693|NCT01848990|E1|Reported Event|Commercial Hylenex Recombinant (Formulation 1)|Hylenex Formulation 1: For 6 months, participants received their regular treatment of rapid-acting continuous CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the commercial form of Hylenex recombinant, delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
127694|NCT01848977|B1|Baseline|Vascular Occlusion Test|"The pediatric SomaSensor™ probe of INVOS® and the 15-mm sensor of InSpectra™ are placed on each thenar muscle in the same subject. The side on which the probe will be placed is randomly determined. INVOS® updates data every 5 s and data (SrO2) will be manually recorded. The data of InSpectra™ (StO2) are automatically collected and sampled every 2 s.~Vascular occlusion test (VOT) is done as follows:Adult-size blood pressure cuffs are placed around each upper arm. The both cuffs are simultaneously inflated to 30 mmHg above the initial systolic blood pressure and kept inflated until the SrO2 or StO2 decreased to 40%. When the value reaches 40% or just below it, the cuff on the same side is deflated rapidly. The data will be collected until the SrO2 and StO2 values returned to the baseline."
127729|NCT01848899|O2|Outcome|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
127730|NCT01848899|O1|Outcome|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
127731|NCT01848899|O2|Outcome|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
127732|NCT01848899|O1|Outcome|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
127733|NCT01848899|O2|Outcome|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
127734|NCT01848899|O1|Outcome|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
127695|NCT01848977|P1|Participant Flow|Vascular Occlusion Test|"The pediatric SomaSensor™ probe of INVOS® and the 15-mm sensor of InSpectra™ are placed on each thenar muscle in the same subject. The side on which the probe will be placed is randomly determined. INVOS® updates data every 5 s and data (SrO2) will be manually recorded. The data of InSpectra™ (StO2) are automatically collected and sampled every 2 s.~Vascular occlusion test (VOT) is done as follows:Adult-size blood pressure cuffs are placed around each upper arm. The both cuffs are simultaneously inflated to 30 mmHg above the initial systolic blood pressure and kept inflated until the SrO2 or StO2 decreased to 40%. When the value reaches 40% or just below it, the cuff on the same side is deflated rapidly. The data will be collected until the SrO2 and StO2 values returned to the baseline."
127696|NCT01848977|O2|Outcome|InSpectra™|Data from InSpectra™ during VOT were manually recorded. Reactive hyperemic area were calculated and compared to INVOS®.
127697|NCT01848977|O1|Outcome|INVOS®|Data from INVOS® during VOT were manually recorded. Reactive hyperemic area were calculated and compared to InSpectra™ .
127698|NCT01848977|O2|Outcome|InSpectra™|Basline value before VOT,and minimum/ maximum values of InSpectra™ were obtained and compared to INVOS®.
127699|NCT01848977|O1|Outcome|INVOS®|Basline value before VOT,and minimum/ maximum values of INVOS® were obtained and compared to InSpectra™ .
127700|NCT01848977|O2|Outcome|InSpectra™|Data from InSpectra™ during VOT were manually recorded. Desaturation and reoxygenation rate were calculated and compared to INVOS®.
127701|NCT01848977|O1|Outcome|INVOS®|Data from INVOS® during VOT were manually recorded. Desaturation and reoxygenation rate were calculated and compared to InSpectra™ .
127702|NCT01848977|E1|Reported Event|Vascular Occlusion Test|"The pediatric SomaSensor™ probe of INVOS® and the 15-mm sensor of InSpectra™ are placed on each thenar muscle in the same subject. The side on which the probe will be placed is randomly determined. INVOS® updates data every 5 s and data (SrO2) will be manually recorded. The data of InSpectra™ (StO2) are automatically collected and sampled every 2 s.~Vascular occlusion test (VOT) is done as follows:Adult-size blood pressure cuffs are placed around each upper arm. The both cuffs are simultaneously inflated to 30 mmHg above the initial systolic blood pressure and kept inflated until the SrO2 or StO2 decreased to 40%. When the value reaches 40% or just below it, the cuff on the same side is deflated rapidly. The data will be collected until the SrO2 and StO2 values returned to the baseline."
127703|NCT01848938|B3|Baseline|Total|Total of all reporting groups
127704|NCT01848938|B2|Baseline|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
127705|NCT01848938|B1|Baseline|Smartphone Treatment|"Smartphone treatment with pelvic floor muscle training (PFMT).~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
127706|NCT01848938|P2|Participant Flow|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
127707|NCT01848938|P1|Participant Flow|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
127708|NCT01848938|O2|Outcome|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
127709|NCT01848938|O1|Outcome|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
127710|NCT01848938|O2|Outcome|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
127711|NCT01848938|O1|Outcome|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
127712|NCT01848938|O2|Outcome|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
127713|NCT01848938|O1|Outcome|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
127714|NCT01848938|O2|Outcome|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
127715|NCT01848938|O1|Outcome|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
127716|NCT01848938|O2|Outcome|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
127717|NCT01848938|O1|Outcome|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
127718|NCT01848938|O2|Outcome|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
127719|NCT01848938|O1|Outcome|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
127720|NCT01848938|E2|Reported Event|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
127721|NCT01848938|E1|Reported Event|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
127722|NCT01848899|B3|Baseline|Total|Total of all reporting groups
127735|NCT01848899|O2|Outcome|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
127736|NCT01848899|O1|Outcome|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
127737|NCT01848899|E2|Reported Event|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
127738|NCT01848899|E1|Reported Event|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
127739|NCT01848847|B3|Baseline|Total|Total of all reporting groups
127740|NCT01848847|B2|Baseline|Full Bladder|"Hysteroscopy conducted under full bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
127741|NCT01848847|B1|Baseline|Empty Bladder|"Hysteroscopy conducted under empty bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
127742|NCT01848847|P2|Participant Flow|Full Bladder|"Hysteroscopy conducted under full bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
127743|NCT01848847|P1|Participant Flow|Empty Bladder|"Hysteroscopy conducted under empty bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
127744|NCT01848847|O2|Outcome|Full Bladder|"Hysteroscopy conducted under full bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
127745|NCT01848847|O1|Outcome|Empty Bladder|"Hysteroscopy conducted under empty bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
127746|NCT01848847|O2|Outcome|Full Bladder|"Hysteroscopy conducted under full bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
127747|NCT01848847|O1|Outcome|Empty Bladder|"Hysteroscopy conducted under empty bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
127748|NCT01848847|E2|Reported Event|Full Bladder|"Hysteroscopy conducted under full bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
127749|NCT01848847|E1|Reported Event|Empty Bladder|"Hysteroscopy conducted under empty bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
127750|NCT01848834|B6|Baseline|Total|Total of all reporting groups
127751|NCT01848834|B5|Baseline|Cohort B2: Head & Neck Cancer Expansion|Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127752|NCT01848834|B4|Baseline|Cohort D: Gastric Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127753|NCT01848834|B3|Baseline|Cohort C: Urothelial Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127754|NCT01848834|B2|Baseline|Cohort B: Head & Neck Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127755|NCT01848834|B1|Baseline|Cohort A: Triple Negative Breast Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127756|NCT01848834|P5|Participant Flow|Cohort B2: Head & Neck Cancer Expansion|Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127757|NCT01848834|P4|Participant Flow|Cohort D: Gastric Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127758|NCT01848834|P3|Participant Flow|Cohort C: Urothelial Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127759|NCT01848834|P2|Participant Flow|Cohort B: Head & Neck Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127760|NCT01848834|P1|Participant Flow|Cohort A: Triple Negative Breast Cancer|Participants received pembrolizumab, 10 mg/kg, intravenously (IV) once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127815|NCT01848288|O1|Outcome|CENTURION Vision System|CENTURION® Vision System randomly assigned to first surgical eye, with INFINITI® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
127761|NCT01848834|O5|Outcome|Cohort B2: Head & Neck Cancer Expansion|Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127762|NCT01848834|O4|Outcome|Cohort D: Gastric Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127763|NCT01848834|O3|Outcome|Cohort C: Urothelial Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127764|NCT01848834|O2|Outcome|Cohort B: Head & Neck Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127765|NCT01848834|O1|Outcome|Cohort A: Triple Negative Breast Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127766|NCT01848834|O1|Outcome|Cohort B2: Head & Neck Cancer Expansion|Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127767|NCT01848834|O4|Outcome|Cohort D: Gastric Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127768|NCT01848834|O3|Outcome|Cohort C: Urothelial Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127769|NCT01848834|O2|Outcome|Cohort B: Head & Neck Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127770|NCT01848834|O1|Outcome|Cohort A: Triple Negative Breast Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127771|NCT01848834|O1|Outcome|Cohorts B & B2: Head & Neck Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks (Cohort B) or pembrolizumab, 200 mg, IV once every 3 weeks (Cohort B2), and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127772|NCT01848834|O1|Outcome|Cohort D: Gastric Cancer AP Participants|Participants who were from the Asia Pacific region received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127773|NCT01848834|O1|Outcome|Cohorts B & B2: Head & Neck Cancer HPV-positive Participants|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks or pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127774|NCT01848834|O1|Outcome|Cohort B2: Head & Neck Cancer Expansion|Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127775|NCT01848834|O4|Outcome|Cohort D: Gastric Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127855|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
128888|NCT01843972|E1|Reported Event|Placebo (Part I)|"placebo solution~Placebo: placebo solution"
127776|NCT01848834|O3|Outcome|Cohort C: Urothelial Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127777|NCT01848834|O2|Outcome|Cohort B: Head & Neck Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127778|NCT01848834|O1|Outcome|Cohort A: Triple Negative Breast Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127779|NCT01848834|O5|Outcome|Cohort B2: Head & Neck Cancer Expansion|Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127780|NCT01848834|O4|Outcome|Cohort D: Gastric Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127781|NCT01848834|O3|Outcome|Cohort C: Urothelial Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127782|NCT01848834|O2|Outcome|Cohort B: Head & Neck Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127783|NCT01848834|O1|Outcome|Cohort A: Triple Negative Breast Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127784|NCT01848834|O5|Outcome|Cohort B2: Head & Neck Cancer Expansion|Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127785|NCT01848834|O4|Outcome|Cohort D: Gastric Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127786|NCT01848834|O3|Outcome|Cohort C: Urothelial Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127787|NCT01848834|O2|Outcome|Cohort B: Head & Neck Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127788|NCT01848834|O1|Outcome|Cohort A: Triple Negative Breast Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127789|NCT01848834|E5|Reported Event|Cohort D: Gastric Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127790|NCT01848834|E4|Reported Event|Cohort C: Urothelial Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127791|NCT01848834|E3|Reported Event|Cohort A: Triple Negative Breast Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127792|NCT01848834|E2|Reported Event|Cohort B2: Head & Neck Cancer Expansion|Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127793|NCT01848834|E1|Reported Event|Cohort B: Head & Neck Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
127794|NCT01848756|B1|Baseline|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
127795|NCT01848756|P1|Participant Flow|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
127796|NCT01848756|O1|Outcome|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
127797|NCT01848756|O1|Outcome|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
127798|NCT01848756|O1|Outcome|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
127799|NCT01848756|O1|Outcome|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
127800|NCT01848756|O1|Outcome|SNX-5422|SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle.
127801|NCT01848756|O1|Outcome|SNX-5422|SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle.
127802|NCT01848756|O1|Outcome|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
127803|NCT01848756|E1|Reported Event|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
127804|NCT01848366|B1|Baseline|Biowave Treatment|"Twelve weekly treatments~Biowave Treatment: Twelve weekly treatments"
127805|NCT01848366|P1|Participant Flow|Biowave Treatment|"Twelve weekly treatments~Biowave Treatment: Twelve weekly treatments"
127806|NCT01848366|O1|Outcome|Biowave Treatment|"Twelve weekly treatments~Biowave Treatment: Twelve weekly treatments"
127807|NCT01848366|E1|Reported Event|Biowave Treatment|"Twelve weekly treatments~Biowave Treatment: Twelve weekly treatments"
127808|NCT01848288|B1|Baseline|Overall|First surgical eye randomly assigned to CENTURION® Vision System or INFINITI® Vision System, with the second surgical eye (fellow eye) assigned to the alternative group.
127809|NCT01848288|P1|Participant Flow|Overall|First surgical eye randomly assigned to CENTURION® Vision System or INFINITI® Vision System, with the second surgical eye (fellow eye) assigned to the alternative group.
127810|NCT01848288|O2|Outcome|INFINITI Vision System|INFINITI® Vision System randomly assigned to first surgical eye, with CENTURION® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
127811|NCT01848288|O1|Outcome|CENTURION Vision System|CENTURION® Vision System randomly assigned to first surgical eye, with INFINITI® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
127812|NCT01848288|O2|Outcome|INFINITI Vision System|INFINITI® Vision System randomly assigned to first surgical eye, with CENTURION® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
127813|NCT01848288|O1|Outcome|CENTURION Vision System|CENTURION® Vision System randomly assigned to first surgical eye, with INFINITI® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
127814|NCT01848288|O2|Outcome|INFINITI Vision System|INFINITI® Vision System randomly assigned to first surgical eye, with CENTURION® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
127928|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
127816|NCT01848288|E1|Reported Event|Overall|"First surgical eye randomly assigned to CENTURION® Vision System or INFINITI® Vision System, with the second surgical eye (fellow eye) assigned to the alternative group. For non-ocular adverse events, at risk population is included with unit of subjects. For ocular adverse events, at risk population is included with unit of eyes by treatment group."
127817|NCT01848210|B3|Baseline|Total|Total of all reporting groups
127818|NCT01848210|B2|Baseline|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
127819|NCT01848210|B1|Baseline|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
127820|NCT01848210|P2|Participant Flow|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
127821|NCT01848210|P1|Participant Flow|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
127822|NCT01848210|O2|Outcome|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
127823|NCT01848210|O1|Outcome|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
127824|NCT01848210|O2|Outcome|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
127825|NCT01848210|O1|Outcome|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
127826|NCT01848210|O2|Outcome|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
127827|NCT01848210|O1|Outcome|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
127828|NCT01848210|O2|Outcome|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
127829|NCT01848210|O1|Outcome|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
127830|NCT01848210|E2|Reported Event|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
127831|NCT01848210|E1|Reported Event|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
127832|NCT01848145|B1|Baseline|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion. The goal is to complete infusion #3 within 120 minutes (+/- 15 minutes).~Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.~Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.~Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)~Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
127833|NCT01848145|P1|Participant Flow|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion. .~Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.~Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.~Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)~Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
127834|NCT01848145|O1|Outcome|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion.~Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.~Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.~Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)~Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
127835|NCT01848145|O1|Outcome|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion.~Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.~Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.~Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)~Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
127836|NCT01848145|O1|Outcome|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion.~Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.~Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.~Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)~Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
128889|NCT01843933|B3|Baseline|Total|Total of all reporting groups
127837|NCT01848145|O1|Outcome|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion.~Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.~Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.~Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)~Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
127838|NCT01848145|O1|Outcome|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion.~Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.~Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.~Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)~Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
127839|NCT01848145|O1|Outcome|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion.~Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.~Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.~Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)~Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
127840|NCT01848145|E1|Reported Event|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion. The goal infusion time at Infusion #3 is 120 minutes.~Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.~Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.~Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)~Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
127841|NCT01848067|B1|Baseline|Treatment (Alisertib, Abiraterone Acetate, Prednisone)|"Patients receive alisertib PO BID on days 1-7, abiraterone acetate PO daily, and prednisone PO BID. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Alisertib: Given PO~Abiraterone acetate: Given PO~Prednisone: Given PO"
127842|NCT01848067|P1|Participant Flow|Treatment (Alisertib, Abiraterone Acetate, Prednisone)|"Patients receive alisertib PO BID on days 1-7, abiraterone acetate PO daily, and prednisone PO BID. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Alisertib: Given PO~Abiraterone acetate: Given PO~Prednisone: Given PO"
127843|NCT01848067|O1|Outcome|Treatment (Alisertib, Abiraterone Acetate, Prednisone)|"Patients receive alisertib PO BID on days 1-7, abiraterone acetate PO daily, and prednisone PO BID. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Alisertib: Given PO~Abiraterone acetate: Given PO~Prednisone: Given PO"
127844|NCT01848067|O1|Outcome|Treatment (Alisertib, Abiraterone Acetate, Prednisone)|"Patients receive alisertib PO BID on days 1-7, abiraterone acetate PO daily, and prednisone PO BID. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Alisertib: Given PO~Abiraterone acetate: Given PO~Prednisone: Given PO"
127845|NCT01848067|O1|Outcome|Treatment (Alisertib, Abiraterone Acetate, Prednisone)|"Patients receive alisertib PO BID on days 1-7, abiraterone acetate PO daily, and prednisone PO BID. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Alisertib: Given PO~Abiraterone acetate: Given PO~Prednisone: Given PO"
127846|NCT01848067|E1|Reported Event|Treatment (Alisertib, Abiraterone Acetate, Prednisone)|"Patients receive alisertib PO BID on days 1-7, abiraterone acetate PO daily, and prednisone PO BID. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Alisertib: Given PO~Abiraterone acetate: Given PO~Prednisone: Given PO"
127847|NCT01848054|B3|Baseline|Total|Total of all reporting groups
127848|NCT01848054|B2|Baseline|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
127849|NCT01848054|B1|Baseline|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
127850|NCT01848054|P2|Participant Flow|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
127851|NCT01848054|P1|Participant Flow|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
127852|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with OX219 buprenorphine/naloxone sublingual tablets (open-label)
127853|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
127854|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
127929|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
127856|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
127857|NCT01848054|O1|Outcome|BNX Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
127858|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
127859|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Day 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
127860|NCT01848054|O2|Outcome|Buprenorphine Induction|"Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with OX219 buprenorphine/naloxone sublingual tablets (open-label)~OX219 buprenorphine/naloxone: OX219 buprenorphine/naloxone sublingual tablets~Buprenorphine: Buprenorphine sublingual tablets"
127861|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
127862|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
127863|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
127864|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
127865|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
127866|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
127867|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
127868|NCT01848054|E2|Reported Event|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
127869|NCT01848054|E1|Reported Event|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
127870|NCT01847885|B3|Baseline|Total|Total of all reporting groups
127871|NCT01847885|B2|Baseline|Smartpatch Control Group (Full Analysis Set)|Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
127872|NCT01847885|B1|Baseline|Smartpatch Treatment Group (Full Analysis Set)|Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
127873|NCT01847885|P3|Participant Flow|Smartpatch Control Group (Full Analysis Set)|Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
127874|NCT01847885|P2|Participant Flow|Smartpatch Treatment Group (Full Analysis Set)|Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
127875|NCT01847885|P1|Participant Flow|Enrolled Subjects|Subjects who signed a consent form.
127876|NCT01847885|O2|Outcome|Smartpatch Control Group (Per Protocol Set)|Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
127877|NCT01847885|O1|Outcome|Smartpatch Treatment Group (Per Protocol Set)|Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
127878|NCT01847885|O2|Outcome|Smartpatch Control Group (Per Protocol Set)|Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
127879|NCT01847885|O1|Outcome|Smartpatch Treatment Group (Per Protocol Set)|Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
127880|NCT01847885|O1|Outcome|Investigators|Investigator(s) at each site performing lead placement
127881|NCT01847885|O2|Outcome|Smartpatch Control Group (Safety Set)|Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
127882|NCT01847885|O1|Outcome|Smartpatch Treatment Group (Safety Set)|Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
127883|NCT01847885|O2|Outcome|Smartpatch Control Group (Safety Set)|Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
127884|NCT01847885|O1|Outcome|Smartpatch Treatment Group (Safety Set)|Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
127885|NCT01847885|O2|Outcome|Smartpatch Control Group (Per Protocol Set)|Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
127886|NCT01847885|O1|Outcome|Smartpatch Treatment Group (Per Protocol Set)|Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
127887|NCT01847885|O2|Outcome|Smartpatch Control Group (Per Protocol Set)|Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
127888|NCT01847885|O1|Outcome|Smartpatch Treatment Group (Per Protocol Set)|Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
127889|NCT01847885|O2|Outcome|Smartpatch Control Group (Per Protocol Set)|Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
127890|NCT01847885|O1|Outcome|Smartpatch Treatment Group (Per Protocol Set)|Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
127891|NCT01847885|O2|Outcome|Smartpatch Control Group (Per Protocol Set)|Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
127892|NCT01847885|O1|Outcome|Smartpatch Treatment Group (Per Protocol Set)|Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
127893|NCT01847885|O2|Outcome|Smartpatch Control Group (Per Protocol Set)|Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
127894|NCT01847885|O1|Outcome|Smartpatch Treatment Group (Per Protocol Set)|Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
127895|NCT01847885|O2|Outcome|Smartpatch Control Group (Full Analysis Set)|Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
127896|NCT01847885|O1|Outcome|Smartpatch Treatment Group (Full Analysis Set)|Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
127897|NCT01847885|O2|Outcome|Smartpatch Control Group (Per Protocol Set)|Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
127898|NCT01847885|O1|Outcome|Smartpatch Treatment Group (Per Protocol Set)|Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
127899|NCT01847885|O2|Outcome|Smartpatch Control Group (Safety Set)|Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
127900|NCT01847885|O1|Outcome|Smartpatch Treatment Group (Safety Set)|Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
127901|NCT01847885|O2|Outcome|Smartpatch Control Group (Full Analysis Set)|Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
127902|NCT01847885|O1|Outcome|Smartpatch Treatment Group (Full Analysis Set)|Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
127903|NCT01847885|E3|Reported Event|Smartpatch Control Group (Safety Set)|Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
127904|NCT01847885|E2|Reported Event|Smartpatch Treatment Group (Safety Set)|Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
127905|NCT01847885|E1|Reported Event|Enrolled Subjects Who Did Not Receive the Study Device|Subjects who were consented, but were not randomized and did not receive the study device or any intervention.
127906|NCT01847547|B3|Baseline|Total|Total of all reporting groups
127907|NCT01847547|B2|Baseline|Warfarin|Propensity score matched patients starting treatment with warfarin
127908|NCT01847547|B1|Baseline|Dabigatran|Propensity score matched patients starting treatment with dabigatran
127909|NCT01847547|P2|Participant Flow|Warfarin|Propensity score matched patients starting treatment with warfarin
127910|NCT01847547|P1|Participant Flow|Dabigatran|Propensity score matched patients starting treatment with dabigatran
127911|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
127912|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
127913|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
127914|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
127915|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
127916|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
127917|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
127918|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
127919|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
127920|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
127921|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
127922|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
127923|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
127924|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
127925|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
127926|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
127927|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
127930|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
127931|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
127932|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
127933|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
127934|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
127935|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
127936|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
127937|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
127938|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
127939|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
127940|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
127941|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
127942|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
127943|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
127944|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
127945|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with warfarin
127946|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
127947|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with warfarin
127948|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
127949|NCT01847547|E2|Reported Event|Warfarin|Propensity score matched patients starting treatment with warfarin
127950|NCT01847547|E1|Reported Event|Dabigatran|Propensity score matched patients starting treatment with dabigatran
127951|NCT01847443|B1|Baseline|Total Participants|
127952|NCT01847443|P4|Participant Flow|4mg Mint Gum/2mg Mint Gum/2mg Ref Gum/4mg Ref Gum|Participants randomly received 4mg nicotine mint gum or 2mg nicotine mint gum or 2mg ref nicotine gum or 4mg ref nicotine gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
127953|NCT01847443|P3|Participant Flow|2mg Ref Gum/4mg Mint Gum/4mg Ref Gum/2mg Mint Gum|Participants randomly received 2mg ref nicotine gum or 4mg nicotine mint gum or 4mg ref nicotine gum or 2mg nicotine mint gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
127954|NCT01847443|P2|Participant Flow|4mg Ref Gum/2mg Ref Gum/2mg Mint Gum/4mg Mint Gum|Participants randomly received 4mg ref nicotine gum or 2mg ref nicotine gum or 2mg nicotine mint gum or 4mg nicotine mint gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
127955|NCT01847443|P1|Participant Flow|2mg Mint Gum/4mg Ref Gum/4mg Mint Gum/2mg Ref Gum|Participants randomly received 2mg nicotine mint gum or 4mg reference (ref) nicotine gum or 4mg nicotine mint gum or 2mg ref nicotine gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
127956|NCT01847443|O2|Outcome|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
127957|NCT01847443|O1|Outcome|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
127958|NCT01847443|O2|Outcome|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
127959|NCT01847443|O1|Outcome|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
127960|NCT01847443|O2|Outcome|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
127961|NCT01847443|O1|Outcome|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
127962|NCT01847443|O4|Outcome|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
127963|NCT01847443|O3|Outcome|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
127964|NCT01847443|O2|Outcome|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
127965|NCT01847443|O1|Outcome|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
127966|NCT01847443|O4|Outcome|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
127967|NCT01847443|O3|Outcome|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
127968|NCT01847443|O2|Outcome|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
127969|NCT01847443|O1|Outcome|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
127970|NCT01847443|O4|Outcome|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
127971|NCT01847443|O3|Outcome|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
127972|NCT01847443|O2|Outcome|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
127973|NCT01847443|O1|Outcome|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
127974|NCT01847443|O4|Outcome|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
127975|NCT01847443|O3|Outcome|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
127976|NCT01847443|O2|Outcome|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
127977|NCT01847443|O1|Outcome|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
127978|NCT01847443|O2|Outcome|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
127979|NCT01847443|O1|Outcome|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
127980|NCT01847443|E4|Reported Event|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
127981|NCT01847443|E3|Reported Event|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
127982|NCT01847443|E2|Reported Event|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
127983|NCT01847443|E1|Reported Event|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
127984|NCT01847430|B1|Baseline|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
127985|NCT01847430|P1|Participant Flow|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
127986|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
127987|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
127988|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
127989|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
127990|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
127991|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
127992|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
127993|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
127994|NCT01847430|E1|Reported Event|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
127995|NCT01847196|B1|Baseline|Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge."
127996|NCT01847196|P1|Participant Flow|Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge."
127997|NCT01847196|O1|Outcome|Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge."
127998|NCT01847196|O1|Outcome|Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge."
127999|NCT01847196|E1|Reported Event|Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge."
128000|NCT01847131|B3|Baseline|Total|Total of all reporting groups
128001|NCT01847131|B2|Baseline|Placebo|"placebo nasal spray 2 sprays in each nostril twice daily~Placebo nasal spray: Placebo nasal spray has made by the local pharmaceutical company in thailand who commercially manufacture and sell 0.05% oxymetazoline nasal spray. The placebo contains the same ingredients as the drug except the active ingredient."
128002|NCT01847131|B1|Baseline|Oxymetazoline|"0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily~oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available."
128003|NCT01847131|P2|Participant Flow|Placebo|"placebo nasal spray 2 sprays in each nostril twice daily~Placebo nasal spray: Placebo nasal spray has made by the local pharmaceutical company in thailand who commercially manufacture and sell 0.05% oxymetazoline nasal spray. The placebo contains the same ingredients as the drug except the active ingredient."
128004|NCT01847131|P1|Participant Flow|Oxymetazoline|"0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily~oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available."
128005|NCT01847131|O2|Outcome|Placebo|"placebo nasal spray 2 sprays in each nostril twice daily~Placebo nasal spray: Placebo nasal spray has made by the local pharmaceutical company in thailand who commercially manufacture and sell 0.05% oxymetazoline nasal spray. The placebo contains the same ingredients as the drug except the active ingredient."
128006|NCT01847131|O1|Outcome|Oxymetazoline|"0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily~oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available."
128068|NCT01846455|B5|Baseline|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128007|NCT01847131|O2|Outcome|Placebo|"placebo nasal spray 2 sprays in each nostril twice daily~Placebo nasal spray: Placebo nasal spray has made by the local pharmaceutical company in thailand who commercially manufacture and sell 0.05% oxymetazoline nasal spray. The placebo contains the same ingredients as the drug except the active ingredient."
128008|NCT01847131|O1|Outcome|Oxymetazoline|"0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily~oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available."
128009|NCT01847131|E2|Reported Event|Placebo|"placebo nasal spray 2 sprays in each nostril twice daily~Placebo nasal spray: Placebo nasal spray has made by the local pharmaceutical company in thailand who commercially manufacture and sell 0.05% oxymetazoline nasal spray. The placebo contains the same ingredients as the drug except the active ingredient."
128010|NCT01847131|E1|Reported Event|Oxymetazoline|"0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily~oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available."
128011|NCT01846741|B1|Baseline|VNS Therapy (ITT Population)|Subjects who were implanted with the AspireSR® VNS Therapy® System.
128012|NCT01846741|P1|Participant Flow|VNS Therapy - ITT Population|"Subjects who were implanted with the AspireSR® VNS Therapy® System.~The intent-to-treat (ITT) population is defined as all subjects with the VNS Therapy system implanted and the device had been turned on."
128013|NCT01846741|O4|Outcome|18-Month|Since Last Visit Assessment
128014|NCT01846741|O3|Outcome|12-Month|Since Last Visit Assessment
128015|NCT01846741|O2|Outcome|6-Month|Since Last Visit Assessment
128016|NCT01846741|O1|Outcome|3-Month|Since Last Visit Assessment
128017|NCT01846741|O4|Outcome|18-Month|Since Last Visit Assessment
128018|NCT01846741|O3|Outcome|12-Month|Since Last Visit Assessment
128019|NCT01846741|O2|Outcome|6-Month|Since Last Visit Assessment
128020|NCT01846741|O1|Outcome|3-Month|Since Last Visit Assessment
128021|NCT01846741|O4|Outcome|18-Month|Since Last Visit Assessment
128022|NCT01846741|O3|Outcome|12-Month|Since Last Visit Assessment
128023|NCT01846741|O2|Outcome|6-Month|Since Last Visit Assessment
128024|NCT01846741|O1|Outcome|3-Month|Since Last Visit Assessment
128025|NCT01846741|O4|Outcome|18-Month|Since Last Visit Assessment
128026|NCT01846741|O3|Outcome|12-Month|Since Last Visit Assessment
128027|NCT01846741|O2|Outcome|6-Month|Since Last Visit Assessment
128028|NCT01846741|O1|Outcome|3-Month|Since Last Visit Assessment
128029|NCT01846741|O4|Outcome|18-Month|Since Last Visit Assessment
128030|NCT01846741|O3|Outcome|12-Month|Since Last Visit Assessment
128031|NCT01846741|O2|Outcome|6-Month|Since Last Visit Assessment
128032|NCT01846741|O1|Outcome|3-Month|Since Last Visit Assessment
128033|NCT01846741|O4|Outcome|6-Month Visit|Users' Overall Assessment of Device Usability
128034|NCT01846741|O3|Outcome|EMU Discharge|Users' Overall Assessment of Device Usability
128035|NCT01846741|O2|Outcome|EMU Day-1|Users' Overall Assessment of Device Usability
128036|NCT01846741|O1|Outcome|Implant/Recovery|Users' Overall Assessment of Device Usability
128037|NCT01846741|O1|Outcome|Number of Subjects|Experienced Adverse Events Greater Than 5% Incidence
128038|NCT01846741|O1|Outcome|VNS Therapy|ITT Population
128039|NCT01846741|O1|Outcome|AED Load|Percent Change From Baseline by Visit
128040|NCT01846741|O2|Outcome|Overall Seizure Responder Rate|Overall Seizure (All Seizure Types)
128041|NCT01846741|O1|Outcome|Partial Onset Seizure Responder Rate|Partial Onset Seizures (SPS, CPS, CPS with Secondary GTC)
128042|NCT01846741|O4|Outcome|QOLIE-31-P Scores at 18-Months|Change From Baseline at Each Category
128043|NCT01846741|O3|Outcome|QOLIE-31-P Scores at 12-Months|Change From Baseline at Each Category
128044|NCT01846741|O2|Outcome|QOLIE-31-P Scores at 6-Months|Change From Baseline at Each Category
128045|NCT01846741|O1|Outcome|QOLIE-31-P Scores at 3-Months|Change From Baseline at Each Category
128046|NCT01846741|O4|Outcome|SSQ Scores at 18 Months|Change From Baseline at Each Category
128047|NCT01846741|O3|Outcome|SSQ Scores at 12 Months|Change From Baseline at Each Category
128048|NCT01846741|O2|Outcome|SSQ Scores at 6 Months|Change From Baseline at Each Category
128049|NCT01846741|O1|Outcome|SSQ Scores at 3 Months|Change From Baseline at Each Category
128050|NCT01846741|O3|Outcome|Simple Partial Seizure (SPS)|NHS3 Scores at Follow-Up Visits
128051|NCT01846741|O2|Outcome|CPS w/2nd GTC|NHS3 Scores at Follow-up Visits
128052|NCT01846741|O1|Outcome|Complex Partial Seizure (CPS)|NHS3 Scores at Follow-Up Visits
128053|NCT01846741|O6|Outcome|Unknown Seizures|During AutoStim Course in The EMU
128054|NCT01846741|O5|Outcome|Sub-Clinical Seizures|During AutoStim Course in The EMU
128055|NCT01846741|O4|Outcome|Simple Partial Seizures|During AutoStim Course in The EMU
128056|NCT01846741|O3|Outcome|Secondary Generalized Seizures|During AutoStim Course in The EMU
128057|NCT01846741|O2|Outcome|Complex Partial Seizures|During AutoStim Course in The EMU
128058|NCT01846741|O1|Outcome|Overall Seizures|During AutoStim Course in The EMU
128059|NCT01846741|O2|Outcome|During EMU Stay Stair-Stepper Exercise|Non-Seizure Related Stimulation Rate (AutoStim Per Hour)
128060|NCT01846741|O1|Outcome|During EMU Stay|Non-Seizure Related Stimulation Rate (AutoStim Per Hour)
128061|NCT01846741|O1|Outcome|% Sensitivity|Based on Heart rate Increase Associated with Seizures by Threshold for AutoStim
128062|NCT01846741|O1|Outcome|% Sensitivity|Based on Heart rate Increase Associated with Seizures by Threshold for AutoStim
128063|NCT01846741|O3|Outcome|Total|Seizures Reported by Investigators and Triple Reviewers
128064|NCT01846741|O2|Outcome|Reported by Triple Review|EMU Seizures Identified Post EMU
128065|NCT01846741|O1|Outcome|Reported By Investigators|All Seizures Identified (During EMU)
128066|NCT01846741|E1|Reported Event|VNS Therapy - Safety Population|All adverse events were collected from baseline up to the end of study for all subjects treated/implanted with the AspireSR® VNS Therapy® system. Only the most common AEs (> 5%) are reported in the AE data table.
128067|NCT01846455|B6|Baseline|Total|Total of all reporting groups
128307|NCT01845831|B3|Baseline|Total|Total of all reporting groups
128069|NCT01846455|B4|Baseline|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128070|NCT01846455|B3|Baseline|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128071|NCT01846455|B2|Baseline|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128072|NCT01846455|B1|Baseline|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128073|NCT01846455|P5|Participant Flow|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128074|NCT01846455|P4|Participant Flow|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128075|NCT01846455|P3|Participant Flow|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128076|NCT01846455|P2|Participant Flow|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128077|NCT01846455|P1|Participant Flow|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128078|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128079|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128080|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128081|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128082|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128083|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128084|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128085|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128086|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128087|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128088|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128089|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128090|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128091|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128092|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128093|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128094|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128095|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128096|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128097|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128098|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128099|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128100|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128101|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128102|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128103|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128104|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128105|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128106|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128107|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128108|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128109|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128110|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128111|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128112|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128113|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128114|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128115|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128116|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128117|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128118|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
157736|NCT01717989|O3|Outcome|Q2 2011|Second quarter (Q2), 2011
128119|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128120|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128121|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128122|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128123|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128124|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128125|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128126|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128127|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128128|NCT01846455|E5|Reported Event|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128129|NCT01846455|E4|Reported Event|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128130|NCT01846455|E3|Reported Event|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128131|NCT01846455|E2|Reported Event|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128132|NCT01846455|E1|Reported Event|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
128133|NCT01846442|B5|Baseline|Total|Total of all reporting groups
128134|NCT01846442|B4|Baseline|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
128135|NCT01846442|B3|Baseline|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
128136|NCT01846442|B2|Baseline|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
128137|NCT01846442|B1|Baseline|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
128138|NCT01846442|P4|Participant Flow|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.0% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
128139|NCT01846442|P3|Participant Flow|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
128140|NCT01846442|P2|Participant Flow|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
128141|NCT01846442|P1|Participant Flow|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
128142|NCT01846442|O4|Outcome|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
128143|NCT01846442|O3|Outcome|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
128144|NCT01846442|O2|Outcome|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
128145|NCT01846442|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
128146|NCT01846442|O4|Outcome|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
128147|NCT01846442|O3|Outcome|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
128148|NCT01846442|O2|Outcome|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
128149|NCT01846442|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
128150|NCT01846442|O4|Outcome|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
128151|NCT01846442|O3|Outcome|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
129002|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
128152|NCT01846442|O2|Outcome|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
128153|NCT01846442|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
128154|NCT01846442|O4|Outcome|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
128155|NCT01846442|O3|Outcome|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
128156|NCT01846442|O2|Outcome|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
128157|NCT01846442|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
128158|NCT01846442|O4|Outcome|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
128159|NCT01846442|O3|Outcome|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
128160|NCT01846442|O2|Outcome|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
128161|NCT01846442|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
128162|NCT01846442|O4|Outcome|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
128163|NCT01846442|O3|Outcome|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
128164|NCT01846442|O2|Outcome|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
128165|NCT01846442|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
128166|NCT01846442|O4|Outcome|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
128167|NCT01846442|O3|Outcome|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
128168|NCT01846442|O2|Outcome|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
128169|NCT01846442|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
128170|NCT01846442|O4|Outcome|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
128171|NCT01846442|O3|Outcome|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
128172|NCT01846442|O2|Outcome|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
128173|NCT01846442|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
128174|NCT01846442|E4|Reported Event|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
128175|NCT01846442|E3|Reported Event|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
128176|NCT01846442|E2|Reported Event|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
128177|NCT01846442|E1|Reported Event|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
128178|NCT01846416|B4|Baseline|Total|Total of all reporting groups
128179|NCT01846416|B3|Baseline|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128180|NCT01846416|B2|Baseline|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128181|NCT01846416|B1|Baseline|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
128182|NCT01846416|P3|Participant Flow|Atezolizumab (MPDL3280): 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128183|NCT01846416|P2|Participant Flow|Atezolizumab (MPDL3280): 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128184|NCT01846416|P1|Participant Flow|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced non-small cell lung cancer (NSCLC) disease received atezolizumab intravenously (IV) as a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle until disease progression.
128185|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : All Arms|All participants included in the study were reported.
128186|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : All Arms|All participants included in the study were reported.
128187|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128188|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128189|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
128190|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128191|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128192|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
128193|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128194|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128195|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
128196|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128197|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128198|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
128199|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128200|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128201|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
128202|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128203|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280): 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128204|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
128205|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128206|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128207|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
157737|NCT01717989|O2|Outcome|Q1 2011|First quarter (Q1), 2011
128208|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128209|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128210|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
128211|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128212|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128213|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
128214|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128215|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128216|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
128217|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128218|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128219|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
128220|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128221|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128222|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
128223|NCT01846416|E3|Reported Event|Atezolizumab (MPDL3280A) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128224|NCT01846416|E2|Reported Event|Atezolizumab (MPDL3280A) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
128225|NCT01846416|E1|Reported Event|Atezolizumab (MPDL3280A) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
128226|NCT01846299|B3|Baseline|Total|Total of all reporting groups
128227|NCT01846299|B2|Baseline|Sham|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
128228|NCT01846299|B1|Baseline|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
128599|NCT01844687|O6|Outcome|Inactive MJ With 200 mg CBD|MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
128229|NCT01846299|P2|Participant Flow|Sham|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
128230|NCT01846299|P1|Participant Flow|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
128231|NCT01846299|O3|Outcome|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
128232|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
128233|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
128234|NCT01846299|O3|Outcome|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
128235|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
128236|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
128237|NCT01846299|O3|Outcome|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
128238|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
128239|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
128240|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
128241|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
128242|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
128243|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
128244|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
128245|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
128246|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
128247|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
128248|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
128249|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
128250|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
128251|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
128252|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
128253|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
128254|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
128255|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
128256|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
128257|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
128600|NCT01844687|O5|Outcome|Inactive MJ With 0 mg CBD|MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
128258|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
128259|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
128260|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
128261|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
128262|NCT01846299|E3|Reported Event|Sham Without Ranibizumab 0.5mg|Sham without Ranibizumab 0.5mg
128263|NCT01846299|E2|Reported Event|Sham With Ranibizumab 0.5mg|Sham with Ranibizumab 0.5mg
128264|NCT01846299|E1|Reported Event|Ranibizumab 0.5mg|Ranibizumab 0.5mg
128265|NCT01846221|B3|Baseline|Total|Total of all reporting groups
128266|NCT01846221|B2|Baseline|Fentanyl|"Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor~Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume."
128267|NCT01846221|B1|Baseline|Clonidine|"Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor~Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume."
128268|NCT01846221|P2|Participant Flow|Fentanyl|"Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor~Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume."
128269|NCT01846221|P1|Participant Flow|Clonidine|"Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor~Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume."
128270|NCT01846221|O2|Outcome|Fentanyl|"Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor~Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume."
128271|NCT01846221|O1|Outcome|Clonidine|"Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor~Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume."
128272|NCT01846221|O2|Outcome|Fentanyl|"Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor~Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume."
128273|NCT01846221|O1|Outcome|Clonidine|"Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor~Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume."
128274|NCT01846221|O2|Outcome|Fentanyl|"Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor~Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume."
128275|NCT01846221|O1|Outcome|Clonidine|"Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor~Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume."
128276|NCT01846221|O2|Outcome|Fentanyl|"Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor~Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume."
128277|NCT01846221|O1|Outcome|Clonidine|"Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor~Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume."
128278|NCT01846221|O2|Outcome|Fentanyl|"Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor~Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume."
128279|NCT01846221|O1|Outcome|Clonidine|"Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor~Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume."
128280|NCT01846221|E2|Reported Event|Fentanyl|"Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor~Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume."
128281|NCT01846221|E1|Reported Event|Clonidine|"Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor~Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume."
128282|NCT01846104|B1|Baseline|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc~50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
128360|NCT01845155|O2|Outcome|Counselling|"Counselling~Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group."
128283|NCT01846104|P1|Participant Flow|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc~50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial (NCT01317667). Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
128284|NCT01846104|O1|Outcome|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc~50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
128285|NCT01846104|O1|Outcome|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc~50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
128286|NCT01846104|O1|Outcome|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc~50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
128287|NCT01846104|E1|Reported Event|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc~50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
128288|NCT01846039|B1|Baseline|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
128289|NCT01846039|P1|Participant Flow|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
128290|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
128291|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
128292|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
128293|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
128294|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
128295|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
128296|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
128297|NCT01846039|E1|Reported Event|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
128298|NCT01845974|B3|Baseline|Total|Total of all reporting groups
128299|NCT01845974|B2|Baseline|High Flow Catheter|"The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.~ThermoCool® catheter: The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group."
128300|NCT01845974|B1|Baseline|Low Flow Catheter|"The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.~ThermoCool® SF NAV Catheter: The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group."
128301|NCT01845974|P2|Participant Flow|High Flow Catheter|"The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.~ThermoCool® catheter: The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group."
128302|NCT01845974|P1|Participant Flow|Low Flow Catheter|"The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.~ThermoCool® SF NAV Catheter: The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group."
128303|NCT01845974|O2|Outcome|High Flow Catheter|"The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.~ThermoCool® catheter: The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group."
128304|NCT01845974|O1|Outcome|Low Flow Catheter|"The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.~ThermoCool® SF NAV Catheter: The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group."
128305|NCT01845974|E2|Reported Event|High Flow Catheter|"The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.~ThermoCool® catheter: The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group."
128306|NCT01845974|E1|Reported Event|Low Flow Catheter|"The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.~ThermoCool® SF NAV Catheter: The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group."
128308|NCT01845831|B2|Baseline|Basal Bolus (Hospital)|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + correction doses of rapid acting insulin if needed"
128309|NCT01845831|B1|Baseline|Sitagliptin + Glargine (Hospital)|"Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
128310|NCT01845831|P5|Participant Flow|Metformin and Sitagliptin + Glargine 80%|"Outpatient Phase:~Patients with HbA1c > 9% during the inpatient phase were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (80% of the inpatient glargine dose) for 6 months~Metformin and sitagliptin + glargine 80%: Patients with HbA1c > 9% were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (80% of the inpatient glargine dose) for 6 months"
128311|NCT01845831|P4|Participant Flow|Metformin and Sitagliptin + Glargine 50%|"Outpatient Phase:~Patients with HbA1c between 7% and 9% during the inpatient phase were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (50% of the inpatient glargine dose) for 6 months~Metformin and sitagliptin + glargine 50%: Patients with HbA1c between 7% and 9% were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (50% of the inpatient glargine dose) for 6 months"
128312|NCT01845831|P3|Participant Flow|Metformin and Sitagliptin|"Outpatient Phase:~Patients with HbA1c ≤ 7% during the inpatient phase were discharged on the combination of metformin and sitagliptin (Janumet ® 500/50 mg) twice daily for 6 months~Metformin and sitagliptin: Patients with HbA1c ≤ 7% were discharged on the combination of metformin and sitagliptin (Janumet ® 500/50 mg) twice daily for 6 months"
128313|NCT01845831|P2|Participant Flow|Basal Bolus (Hospital)|"Inpatient Phase:~Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + correction doses of rapid acting insulin if needed"
128314|NCT01845831|P1|Participant Flow|Sitagliptin + Glargine (Hospital)|"Inpatient Phase:~Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
128315|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
128316|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
128317|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
128318|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
128319|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
128320|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
128321|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
128322|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
128323|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
128324|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
128325|NCT01845831|O3|Outcome|Metformin and Sitagliptin + Glargine 80%|"Outpatient Phase:~Patients with HbA1c > 9% during the inpatient phase were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (80% of the inpatient glargine dose) for 6 months~Metformin and sitagliptin + glargine 80%: Patients with HbA1c > 9% were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (80% of the inpatient glargine dose) for 6 months"
128326|NCT01845831|O2|Outcome|Metformin and Sitagliptin + Glargine 50%|"Outpatient Phase:~Patients with HbA1c between 7% and 9% during the inpatient phase were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (50% of the inpatient glargine dose) for 6 months~Metformin and sitagliptin + glargine 50%: Patients with HbA1c between 7% and 9% were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (50% of the inpatient glargine dose) for 6 months"
128327|NCT01845831|O1|Outcome|Metformin and Sitagliptin|"Outpatient Phase:~Patients with HbA1c < 7% during the inpatient phase were discharged on the combination of metformin and sitagliptin (Janumet ® 500/50 mg) twice daily for 6 months~Metformin and sitagliptin: Patients with HbA1c ≤ 7% were discharged on the combination of metformin and sitagliptin (Janumet ® 500/50 mg) twice daily for 6 months"
128382|NCT01845077|O5|Outcome|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
157738|NCT01717989|O1|Outcome|2010|From June through December 2010
128328|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Inpatient Phase:~Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
128329|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Inpatient Phase:~Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
128330|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Inpatient Phase:~Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
128331|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Inpatient Phase:~Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
128332|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Inpatient Phase:~Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
128333|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Inpatient Phase:~Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
128334|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Inpatient Phase:~Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
128335|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Inpatient Phase:~Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
128336|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
128337|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
128338|NCT01845831|E2|Reported Event|Basal Bolus (Hospital)|"Inpatient Phase:~Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + correction doses of rapid acting insulin if needed"
128339|NCT01845831|E1|Reported Event|Sitagliptin + Glargine (Hospital)|"Inpatient Phase:~Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
128340|NCT01845636|B1|Baseline|Donepezil Treatment & Atropine Challenge|"Atropine nasal spray is administered at baseline for the atropine challenge which involves administration of the 40-item University of Pennsylvania Smell Identification Test (UPSIT) immediately before and 45 minutes after atropine administration. Immediately after the atropine challenge, donepezil treatment is started and continues for 52 weeks.~Donepezil: Donepezil 5mg will be given for 4 weeks and if tolerated, the dose will be increased to 10 mg per day. The dose range of 5 to 10 mg of donepezil per day will be continued for the study duration, and this is the recommended dose for donepezil in the treatment of mild to moderate Alzheimer's disease.~Atropine: A single acute dose of 1 mg of atropine nasal spray is administered to the nostril. The dose chosen reflects clinical doses typically used by Ear, Nose, and Throat (ENT) physicians."
128341|NCT01845636|P1|Participant Flow|Donepezil Treatment & Atropine Challenge|"Atropine nasal spray is administered at baseline for the atropine challenge which involves administration of the 40-item University of Pennsylvania Smell Identification Test (UPSIT) immediately before and 45 minutes after atropine administration. Immediately after the atropine challenge, donepezil treatment is started and continues for 52 weeks.~Donepezil: Donepezil 5mg will be given for 4 weeks and if tolerated, the dose will be increased to 10 mg per day. The dose range of 5 to 10 mg of donepezil per day will be continued for the study duration, and this is the recommended dose for donepezil in the treatment of mild to moderate Alzheimer's disease.~Atropine: A single acute dose of 1 mg of atropine nasal spray is administered to the nostril. The dose chosen reflects clinical doses typically used by Ear, Nose, and Throat (ENT) physicians."
128342|NCT01845636|O1|Outcome|Donepezil Treatment & Atropine Challenge|"Atropine nasal spray is administered at baseline for the atropine challenge which involves administration of the 40-item University of Pennsylvania Smell Identification Test (UPSIT) immediately before and 45 minutes after atropine administration. Immediately after the atropine challenge, donepezil treatment is started and continues for 52 weeks.~Donepezil: Donepezil 5mg will be given for 4 weeks and if tolerated, the dose will be increased to 10 mg per day. The dose range of 5 to 10 mg of donepezil per day will be continued for the study duration, and this is the recommended dose for donepezil in the treatment of mild to moderate Alzheimer's disease.~Atropine: A single acute dose of 1 mg of atropine nasal spray is administered to the nostril. The dose chosen reflects clinical doses typically used by Ear, Nose, and Throat (ENT) physicians."
128343|NCT01845636|O1|Outcome|Donepezil Treatment & Atropine Challenge|"Atropine nasal spray is administered at baseline for the atropine challenge which involves administration of the 40-item University of Pennsylvania Smell Identification Test (UPSIT) immediately before and 45 minutes after atropine administration. Immediately after the atropine challenge, donepezil treatment is started and continues for 52 weeks.~Donepezil: Donepezil 5mg will be given for 4 weeks and if tolerated, the dose will be increased to 10 mg per day. The dose range of 5 to 10 mg of donepezil per day will be continued for the study duration, and this is the recommended dose for donepezil in the treatment of mild to moderate Alzheimer's disease.~Atropine: A single acute dose of 1 mg of atropine nasal spray is administered to the nostril. The dose chosen reflects clinical doses typically used by Ear, Nose, and Throat (ENT) physicians."
128594|NCT01844687|O3|Outcome|Active MJ With 400 mg CBD|MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
128344|NCT01845636|O1|Outcome|Donepezil Treatment & Atropine Challenge|"Atropine nasal spray is administered at baseline for the atropine challenge which involves administration of the 40-item University of Pennsylvania Smell Identification Test (UPSIT) immediately before and 45 minutes after atropine administration. Immediately after the atropine challenge, donepezil treatment is started and continues for 52 weeks.~Donepezil: Donepezil 5mg will be given for 4 weeks and if tolerated, the dose will be increased to 10 mg per day. The dose range of 5 to 10 mg of donepezil per day will be continued for the study duration, and this is the recommended dose for donepezil in the treatment of mild to moderate Alzheimer's disease.~Atropine: A single acute dose of 1 mg of atropine nasal spray is administered to the nostril. The dose chosen reflects clinical doses typically used by Ear, Nose, and Throat (ENT) physicians."
128345|NCT01845636|O1|Outcome|Donepezil Treatment & Atropine Challenge|"Atropine nasal spray is administered at baseline for the atropine challenge which involves administration of the 40-item University of Pennsylvania Smell Identification Test (UPSIT) immediately before and 45 minutes after atropine administration. Immediately after the atropine challenge, donepezil treatment is started and continues for 52 weeks.~Donepezil: Donepezil 5mg will be given for 4 weeks and if tolerated, the dose will be increased to 10 mg per day. The dose range of 5 to 10 mg of donepezil per day will be continued for the study duration, and this is the recommended dose for donepezil in the treatment of mild to moderate Alzheimer's disease.~Atropine: A single acute dose of 1 mg of atropine nasal spray is administered to the nostril. The dose chosen reflects clinical doses typically used by Ear, Nose, and Throat (ENT) physicians."
128346|NCT01845636|O1|Outcome|Donepezil Treatment & Atropine Challenge|"Atropine nasal spray is administered at baseline for the atropine challenge which involves administration of the 40-item University of Pennsylvania Smell Identification Test (UPSIT) immediately before and 45 minutes after atropine administration. Immediately after the atropine challenge, donepezil treatment is started and continues for 52 weeks.~Donepezil: Donepezil 5mg will be given for 4 weeks and if tolerated, the dose will be increased to 10 mg per day. The dose range of 5 to 10 mg of donepezil per day will be continued for the study duration, and this is the recommended dose for donepezil in the treatment of mild to moderate Alzheimer's disease.~Atropine: A single acute dose of 1 mg of atropine nasal spray is administered to the nostril. The dose chosen reflects clinical doses typically used by Ear, Nose, and Throat (ENT) physicians."
128347|NCT01845636|E1|Reported Event|Donepezil Treatment & Atropine Challenge|"Atropine nasal spray is administered at baseline for the atropine challenge which involves administration of the 40-item University of Pennsylvania Smell Identification Test (UPSIT) immediately before and 45 minutes after atropine administration. Immediately after the atropine challenge, donepezil treatment is started and continues for 52 weeks.~Donepezil: Donepezil 5mg will be given for 4 weeks and if tolerated, the dose will be increased to 10 mg per day. The dose range of 5 to 10 mg of donepezil per day will be continued for the study duration, and this is the recommended dose for donepezil in the treatment of mild to moderate Alzheimer's disease.~Atropine: A single acute dose of 1 mg of atropine nasal spray is administered to the nostril. The dose chosen reflects clinical doses typically used by Ear, Nose, and Throat (ENT) physicians."
128348|NCT01845220|B1|Baseline|All Participants|"Total number of subjects is 30. Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions. Thus, 60 skin areas will be randomized.~Broccoli Sprout Extract: 150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge Placebo Comparator."
128349|NCT01845220|P2|Participant Flow|Placebo|"Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.~Placebo: 80% acetone"
128350|NCT01845220|P1|Participant Flow|Broccoli Sprout Extract|"Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.~Broccoli Sprout Extract: 150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge"
128351|NCT01845220|O2|Outcome|Placebo|"Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.~Placebo: 80% acetone"
128352|NCT01845220|O1|Outcome|Broccoli Sprout Extract|"Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.~Broccoli Sprout Extract: 150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge"
128353|NCT01845220|E2|Reported Event|Placebo|"Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.~Placebo: 80% acetone"
128354|NCT01845220|E1|Reported Event|Broccoli Sprout Extract|"Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.~Broccoli Sprout Extract: 150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge"
128355|NCT01845155|B3|Baseline|Total|Total of all reporting groups
128356|NCT01845155|B2|Baseline|Counselling|"Counselling~Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group."
128357|NCT01845155|B1|Baseline|Music Therapy|"Neuro-Music-Therapy according to the Heidelberg Model~Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning.~For more details on the music therapy see Argstatter et al. 2012"
128358|NCT01845155|P2|Participant Flow|Counselling|"Counselling~Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group."
128359|NCT01845155|P1|Participant Flow|Music Therapy|"Neuro-Music-Therapy according to the Heidelberg Model~Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning.~For more details on the music therapy see Argstatter et al. 2012"
128361|NCT01845155|O1|Outcome|Music Therapy|"Neuro-Music-Therapy according to the Heidelberg Model~Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning.~For more details on the music therapy see Argstatter et al. 2012"
128362|NCT01845155|O2|Outcome|Counselling|"Counselling~Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group."
128363|NCT01845155|O1|Outcome|Music Therapy|"Neuro-Music-Therapy according to the Heidelberg Model~Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning.~For more details on the music therapy see Argstatter et al. 2012"
128364|NCT01845155|E2|Reported Event|Counselling|"Counselling~Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group."
128365|NCT01845155|E1|Reported Event|Music Therapy|"Neuro-Music-Therapy according to the Heidelberg Model~Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning.~For more details on the music therapy see Argstatter et al. 2012"
128366|NCT01845103|B1|Baseline|PEARL 8.0|
128367|NCT01845103|P1|Participant Flow|PEARL 8.0|Received TMR with PEARL 8.0
128368|NCT01845103|O1|Outcome|PEARL 8.0|
128369|NCT01845103|O1|Outcome|PEARL 8.0|
128370|NCT01845103|E1|Reported Event|PEARL 8.0|
128371|NCT01845077|B4|Baseline|Total|Total of all reporting groups
128372|NCT01845077|B3|Baseline|Total 1500 Fasted|Patients were administered 2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR orally in the morning under fasted conditions in one treatment period and 1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR orally in the morning under fasted conditions in the other treatment period. Both periods lasted 4 days, separated by a washout period of at least 35 days.
128373|NCT01845077|B2|Baseline|Total 1000 Fed|Patients were administered 1 FDC tablet 5 mg linagliptin/1000 mg metformin XR orally in the morning under fed conditions in one treatment period and 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR orally in the morning under fed conditions in the other treatment period. Both periods lasted 4 days, separated by a washout period of at least 35 days.
128374|NCT01845077|B1|Baseline|Total 1000 Fasted|Patients were administered 1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) orally in the morning under fasted conditions in one treatment period and 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR orally in the morning under fasted conditions in the other treatment period. Both periods lasted 4 days, separated by a washout period of at least 35 days.
128375|NCT01845077|P6|Participant Flow|L+M1500 Fasted, Then FDC1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
128376|NCT01845077|P5|Participant Flow|FDC1500 Fasted, Then L+M1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
128377|NCT01845077|P4|Participant Flow|L+M1000 Fed, Then FDC1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the first treatment period orally in the morning under fed conditions, then 1 FDC tablet 5 mg linagliptin/1000 mg metformin XR administered on Day 1 of the second treatment period orally in the morning under fed conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
128378|NCT01845077|P3|Participant Flow|FDC1000 Fed, Then L+M1000 Fed|1 FDC tablet 5 mg linagliptin/1000 mg metformin XR administered on Day 1 of the first treatment period orally in the morning under fed conditions, then 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the second treatment period orally in the morning under fed conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
128379|NCT01845077|P2|Participant Flow|L+M1000 Fasted, Then FDC1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 1 FDC tablet 5 mg linagliptin/1000 mg metformin XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
128380|NCT01845077|P1|Participant Flow|FDC1000 Fasted, Then L+M1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
128381|NCT01845077|O6|Outcome|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
129003|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
128383|NCT01845077|O4|Outcome|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
128384|NCT01845077|O3|Outcome|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
128385|NCT01845077|O2|Outcome|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
128386|NCT01845077|O1|Outcome|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
128387|NCT01845077|O6|Outcome|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
128388|NCT01845077|O5|Outcome|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
128389|NCT01845077|O4|Outcome|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
128390|NCT01845077|O3|Outcome|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
128391|NCT01845077|O2|Outcome|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
128392|NCT01845077|O1|Outcome|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
128393|NCT01845077|O6|Outcome|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
128394|NCT01845077|O5|Outcome|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
128395|NCT01845077|O4|Outcome|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
128396|NCT01845077|O3|Outcome|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
128397|NCT01845077|O2|Outcome|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
128398|NCT01845077|O1|Outcome|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
128399|NCT01845077|O6|Outcome|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
128400|NCT01845077|O5|Outcome|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
128401|NCT01845077|O4|Outcome|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
128402|NCT01845077|O3|Outcome|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
128403|NCT01845077|O2|Outcome|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
128404|NCT01845077|O1|Outcome|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
128405|NCT01845077|O6|Outcome|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
128406|NCT01845077|O5|Outcome|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
128407|NCT01845077|O4|Outcome|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
128408|NCT01845077|O3|Outcome|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
128409|NCT01845077|O2|Outcome|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
128410|NCT01845077|O1|Outcome|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
128411|NCT01845077|O6|Outcome|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
128412|NCT01845077|O5|Outcome|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
128413|NCT01845077|O4|Outcome|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
128414|NCT01845077|O3|Outcome|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
128415|NCT01845077|O2|Outcome|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
128416|NCT01845077|O1|Outcome|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
128417|NCT01845077|E6|Reported Event|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
128418|NCT01845077|E5|Reported Event|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
128419|NCT01845077|E4|Reported Event|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
128420|NCT01845077|E3|Reported Event|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
128421|NCT01845077|E2|Reported Event|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
128422|NCT01845077|E1|Reported Event|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
128423|NCT01845025|B3|Baseline|Total|Total of all reporting groups
128424|NCT01845025|B2|Baseline|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
128425|NCT01845025|B1|Baseline|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
128426|NCT01845025|P2|Participant Flow|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
128427|NCT01845025|P1|Participant Flow|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
128428|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
128429|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
128430|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
128431|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
128432|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
128433|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
128434|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
128435|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
128436|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
128437|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
128438|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
128439|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
128440|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
128441|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
128442|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
128443|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
128444|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
128445|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
128446|NCT01845025|E2|Reported Event|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
128447|NCT01845025|E1|Reported Event|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
128448|NCT01844895|B1|Baseline|125 mg Abatacept (Autoinjector and Prefilled Syringe)|Participants self administered 125 mg SC abatacept weekly via prefilled syringe from Day 1 up to Day 29. Starting on Day 29, 125 mg SC abatacept was self administered weekly via autoinjector for 3 months.
128449|NCT01844895|P1|Participant Flow|125 mg Abatacept (Autoinjector and Prefilled Syringe)|125 mg SC abatacept was self administered weekly via pre-filled syringes from Day 1 up to Day 29 when the participant was switched to self administering 125 mg SC abatacept via the autoinjector device for 3 months. Participants could discontinue from the autoinjector substudy and switch back to prefilled syringes at any time during the study. Following the 4 months of the substudy, participants could continue to receive abatacept SC via the autoinjector or switch back to the prefilled syringe until the close of the IM101-174 parent study.
128450|NCT01844895|O2|Outcome|125 mg Abatacept SC Autoinjector- Day 113|125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days throughout the substudy.
128451|NCT01844895|O1|Outcome|125 mg Abatacept SC Prefilled Syringe - Day 29|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
128595|NCT01844687|O2|Outcome|Active MJ With 200 mg CBD|MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
128452|NCT01844895|O2|Outcome|125 mg Abatacept SC Using Autoinjector|125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days throughout the substudy.
128453|NCT01844895|O1|Outcome|125 mg Abatacept SC Using Prefilled Syringe|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
128454|NCT01844895|O2|Outcome|125 mg Abatacept SC Autoinjector-Days 106, 108, 109, 110, 113|125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
128455|NCT01844895|O1|Outcome|125 mg Abatacept SC Prefilled Syringe-Days 22, 24, 25, 26, 29|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
128456|NCT01844895|O2|Outcome|125 mg Abatacept SC Autoinjector-Days 106, 108, 109, 110, 113|125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
128457|NCT01844895|O1|Outcome|125 mg Abatacept SC Prefilled Syringe-Days 22, 24, 25, 26, 29|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
128458|NCT01844895|O2|Outcome|125 mg Abatacept SC Autoinjector-Days 106, 108, 109, 110, 113|125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
128459|NCT01844895|O1|Outcome|125 mg Abatacept SC Prefilled Syringe - Days 22, 24, 25, 26,29|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
128460|NCT01844895|O2|Outcome|125 mg Abatacept SC Using Autoinjector - Day 113|125 mg Abatacept SC was self-administered with an autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
128461|NCT01844895|O1|Outcome|125 mg Abatacept SC Using Prefilled Syringe - Day 29|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
128462|NCT01844895|E2|Reported Event|Abatacept Cumulative (Prefilled Syringe and Autoinjector)|125 mg SC abatacept was self administered weekly via pre-filled syringes from Day 1 up to Day 29 when the participant was switched to self administering 125 mg SC abatacept via the autoinjector device for 3 months.
128463|NCT01844895|E1|Reported Event|Abatacept Via Autoinjector Only (Day 29 to End of Study)|Participants received 125 mg SC abatacept via the autoinjector starting Day 29 and through the remaining 3 months of the substudy.
128464|NCT01844856|B3|Baseline|Total|Total of all reporting groups
128465|NCT01844856|B2|Baseline|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
128466|NCT01844856|B1|Baseline|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days.
128467|NCT01844856|P2|Participant Flow|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 grams (g) every 24 hours (q24h) for a minimum of 4 days and a maximum of 14 days.
128468|NCT01844856|P1|Participant Flow|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered intravenously (IV) at a dose of 1.0 milligrams per kilogram of body weight (mg/kg) every 12 hours (q12h) for a minimum of 4 days and a maximum of 14 days.
128469|NCT01844856|O2|Outcome|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
128470|NCT01844856|O1|Outcome|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days.
128471|NCT01844856|O2|Outcome|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
128472|NCT01844856|O1|Outcome|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days.
128473|NCT01844856|O2|Outcome|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
128474|NCT01844856|O1|Outcome|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days.
128475|NCT01844856|E2|Reported Event|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
128476|NCT01844856|E1|Reported Event|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days.
128477|NCT01844830|B3|Baseline|Total|Total of all reporting groups
128478|NCT01844830|B2|Baseline|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Placebo: Inactive ingredients supplied in identical nasal sprayer"
128479|NCT01844830|B1|Baseline|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
128480|NCT01844830|P2|Participant Flow|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Placebo: Inactive ingredients supplied in identical nasal sprayer"
128481|NCT01844830|P1|Participant Flow|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
128596|NCT01844687|O1|Outcome|Active MJ With 0 mg CBD|MJ cigarette with 5.3% THC content pretreated with 0 mg CBD
157739|NCT01717989|O5|Outcome|December 2011|
128482|NCT01844830|O2|Outcome|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Placebo: Inactive ingredients supplied in identical nasal sprayer"
128483|NCT01844830|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
128484|NCT01844830|O2|Outcome|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Placebo: Inactive ingredients supplied in identical nasal sprayer"
128485|NCT01844830|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
128486|NCT01844830|O2|Outcome|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Placebo: Inactive ingredients supplied in identical nasal sprayer"
128487|NCT01844830|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
128488|NCT01844830|O2|Outcome|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Placebo: Inactive ingredients supplied in identical nasal sprayer"
128489|NCT01844830|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
128490|NCT01844830|O2|Outcome|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Placebo: Inactive ingredients supplied in identical nasal sprayer"
128491|NCT01844830|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
128492|NCT01844830|O2|Outcome|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Placebo: Inactive ingredients supplied in identical nasal sprayer"
128493|NCT01844830|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
128494|NCT01844830|O2|Outcome|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Placebo: Inactive ingredients supplied in identical nasal sprayer"
128495|NCT01844830|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
128496|NCT01844830|O2|Outcome|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Placebo: Inactive ingredients supplied in identical nasal sprayer"
128497|NCT01844830|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
128498|NCT01844830|O2|Outcome|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Placebo: Inactive ingredients supplied in identical nasal sprayer"
128499|NCT01844830|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
157740|NCT01717989|O4|Outcome|September 2011|
128500|NCT01844830|O2|Outcome|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Placebo: Inactive ingredients supplied in identical nasal sprayer"
128501|NCT01844830|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
128502|NCT01844830|O2|Outcome|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Placebo: Inactive ingredients supplied in identical nasal sprayer"
128503|NCT01844830|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
128504|NCT01844830|O2|Outcome|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Placebo: Inactive ingredients supplied in identical nasal sprayer"
128505|NCT01844830|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
128506|NCT01844830|E2|Reported Event|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Placebo: Inactive ingredients supplied in identical nasal sprayer"
128507|NCT01844830|E1|Reported Event|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
128508|NCT01844817|B3|Baseline|Total|Total of all reporting groups
128509|NCT01844817|B2|Baseline|Placebo|"Placebo (Dextrose 5% in Water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
128510|NCT01844817|B1|Baseline|OGX-427|"OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
128511|NCT01844817|P2|Participant Flow|Placebo|"Placebo (dextrose 5% in water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
128512|NCT01844817|P1|Participant Flow|OGX-427|"OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
128513|NCT01844817|O2|Outcome|Placebo|"Placebo (Dextrose 5% in water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
128514|NCT01844817|O1|Outcome|OGX-427|"OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
128515|NCT01844817|O2|Outcome|Placebo|"Placebo (Dextrose 5% in Water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
128516|NCT01844817|O1|Outcome|OGX-427|"OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
128597|NCT01844687|O8|Outcome|Inactive MJ With 800 mg CBD|MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
157741|NCT01717989|O3|Outcome|June 2011|
128517|NCT01844817|O2|Outcome|Placebo|"Placebo (Dextrose 5% in Water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
128518|NCT01844817|O1|Outcome|OGX-427|"OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
128519|NCT01844817|E2|Reported Event|Placebo|"Placebo (dextrose 5% in water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
128520|NCT01844817|E1|Reported Event|OGX-427|"OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
128521|NCT01844778|B4|Baseline|Total|Total of all reporting groups
128522|NCT01844778|B3|Baseline|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
128523|NCT01844778|B2|Baseline|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
128524|NCT01844778|B1|Baseline|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
128525|NCT01844778|P3|Participant Flow|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
128526|NCT01844778|P2|Participant Flow|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
128527|NCT01844778|P1|Participant Flow|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
128528|NCT01844778|O3|Outcome|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
128529|NCT01844778|O2|Outcome|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
128530|NCT01844778|O1|Outcome|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
128531|NCT01844778|O3|Outcome|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
128532|NCT01844778|O2|Outcome|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
128533|NCT01844778|O1|Outcome|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
128534|NCT01844778|O3|Outcome|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
128535|NCT01844778|O2|Outcome|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
128536|NCT01844778|O1|Outcome|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
128537|NCT01844778|O3|Outcome|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
128598|NCT01844687|O7|Outcome|Inactive MJ With 400 mg CBD|MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
128538|NCT01844778|O2|Outcome|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
128539|NCT01844778|O1|Outcome|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
128540|NCT01844778|O3|Outcome|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
128541|NCT01844778|O2|Outcome|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
128542|NCT01844778|O1|Outcome|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
128543|NCT01844778|E7|Reported Event|Overall TIP Cycle 2|During the second cycle, each treatment group received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
128544|NCT01844778|E6|Reported Event|TIP/TIP - Cycle 2|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
128545|NCT01844778|E5|Reported Event|TIP/TIP - Cycle 1|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
128546|NCT01844778|E4|Reported Event|COLI/TIP - Cycle 2|During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
128547|NCT01844778|E3|Reported Event|COLI/TIP - Cycle 1|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines.
128548|NCT01844778|E2|Reported Event|TIS/TIP - Cycle 2|During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
128549|NCT01844778|E1|Reported Event|TIS/TIP - Cycle 1|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment.
128550|NCT01844765|B3|Baseline|Total|Total of all reporting groups
128551|NCT01844765|B2|Baseline|Newly Diagnosed and Untreated Ph+ CML in First CP|Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis.
128552|NCT01844765|B1|Baseline|Resistant/Intolerant Ph+ CML in CP|Patients resistant or intolerant to either imatinib or dasatinib
128553|NCT01844765|P2|Participant Flow|Newly Diagnosed and Untreated Ph+ CML in First CP|Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis.
128554|NCT01844765|P1|Participant Flow|Resistant/Intolerant Ph+ CML in CP|Patients resistant or intolerant to either imatinib or dasatinib
128555|NCT01844765|O1|Outcome|Newly Diagnosed and Untreated Ph+ CML in First CP|Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis.
128556|NCT01844765|O1|Outcome|Newly Diagnosed and Untreated Ph+ CML in First CP|Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis.
128557|NCT01844765|O1|Outcome|Newly Diagnosed and Untreated Ph+ CML in First CP|Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis.
128558|NCT01844765|O1|Outcome|Resistant/Intolerant Ph+ CML in CP|Patients resistant or intolerant to either imatinib or dasatinib
128559|NCT01844765|O1|Outcome|Resistant/Intolerant Ph+ CML in CP|Patients resistant or intolerant to either imatinib or dasatinib
128560|NCT01844765|O1|Outcome|Resistant/Intolerant Ph+ CML in CP|Patients resistant or intolerant to either imatinib or dasatinib
128561|NCT01844765|O1|Outcome|Resistant/Intolerant Ph+ CML in CP|Patients resistant or intolerant to either imatinib or dasatinib
128562|NCT01844765|O1|Outcome|Newly Diagnosed and Untreated Ph+ CML in First CP|Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis.
128563|NCT01844765|O1|Outcome|Newly Diagnosed and Untreated Ph+ CML in First CP|Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis.
128564|NCT01844765|O1|Outcome|Newly Diagnosed and Untreated Ph+ CML in First CP|Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis.
128565|NCT01844765|O1|Outcome|Newly Diagnosed and Untreated Ph+ CML in First CP|Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis.
128566|NCT01844765|O1|Outcome|Newly Diagnosed and Untreated Ph+ CML in First CP|Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis.
128567|NCT01844765|O1|Outcome|Newly Diagnosed and Untreated Ph+ CML in First CP|Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis.
128568|NCT01844765|O1|Outcome|Resistant/Intolerant Ph+ CML in CP|Patients resistant or intolerant to either imatinib or dasatinib
128569|NCT01844765|E2|Reported Event|Newly Diagnosed and Untreated Ph+ CML in First CP|Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis.
128570|NCT01844765|E1|Reported Event|Resistant/Intolerant Ph+ CML in CP|Patients resistant or intolerant to either imatinib or dasatinib
128571|NCT01844700|B3|Baseline|Total|Total of all reporting groups
128572|NCT01844700|B2|Baseline|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks~aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)~3 patients were randomized to usual care"
128573|NCT01844700|B1|Baseline|Ziprasidone|"(20-160mg/d, bid) for 12 weeks~Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)~4 patients were randomized to Ziprasidone"
128574|NCT01844700|P2|Participant Flow|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks~aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)~3 participants"
128575|NCT01844700|P1|Participant Flow|Ziprasidone|"(20-160mg/d, bid) for 12 weeks~Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)~4 participants"
128576|NCT01844700|O2|Outcome|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks~aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)~3 participants, only two completed study, no sufficient data for weight changes"
128577|NCT01844700|O1|Outcome|Ziprasidone|"(20-160mg/d, bid) for 12 weeks~Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)~4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes"
128578|NCT01844700|O2|Outcome|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks~aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)~3 participants, only two completed study, no sufficient data for weight changes"
128579|NCT01844700|O1|Outcome|Ziprasidone|"(20-160mg/d, bid) for 12 weeks~Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)~4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes"
128580|NCT01844700|O2|Outcome|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks~aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)~3 participants, only two completed study, no sufficient data for weight changes"
128581|NCT01844700|O1|Outcome|Ziprasidone|"(20-160mg/d, bid) for 12 weeks~Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)~4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes"
128582|NCT01844700|O2|Outcome|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks~aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)~3 participants, only two completed study, no sufficient data for weight changes"
128583|NCT01844700|O1|Outcome|Ziprasidone|"(20-160mg/d, bid) for 12 weeks~Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)~4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes"
128584|NCT01844700|E2|Reported Event|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks~aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)~3 participants, only two completed study, no sufficient data for weight changes~there were no serious adverse events in this group"
128585|NCT01844700|E1|Reported Event|Ziprasidone|"(20-160mg/d, bid) for 12 weeks~Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)~4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes~there were no serious adverse events in this group"
128586|NCT01844687|B1|Baseline|Single Group|"Each subject in the study will be tested on eight days, each day receiving a different combination of active/inactive marijuana cigarette plus 0, 200, 400 or 800 mg of cannabidiol~A subset of study completers will be given 800 mg of cannabidiol on one additional study visit to measure plasma concentrations of cannabidiol for up to 360 minutes after ingestion"
128587|NCT01844687|P1|Participant Flow|Single Group|"Each subject in the study will be tested on eight days, each day receiving a different combination of active/inactive marijuana cigarette plus 0, 200, 400 or 800 mg of cannabidiol~A subset of study completers will be given 800 mg of cannabidiol on one additional study visit to measure plasma concentrations of cannabidiol for up to 360 minutes after ingestion"
128588|NCT01844687|O1|Outcome|Plasma CBD Concentrations|Eight of the 31 participants who completed the study came to a ninth session to receive 800 mg CBD and donate seven blood samples over six hours, one immediately before swallowing CBD capsules, and 6 throughout the next six hours. Plasma samples were analyzed through NIDA contract #NO1DA-14-7788 to David Moody, Ph.D.
128589|NCT01844687|O8|Outcome|Inactive MJ With 800 mg CBD|MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
128590|NCT01844687|O7|Outcome|Inactive MJ With 400 mg CBD|MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
128591|NCT01844687|O6|Outcome|Inactive MJ With 200 mg CBD|MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
128592|NCT01844687|O5|Outcome|Inactive MJ With 0 mg CBD|MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
128593|NCT01844687|O4|Outcome|Active MJ With 800 mg CBD|MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
128601|NCT01844687|O4|Outcome|Active MJ With 800 mg CBD|MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
128602|NCT01844687|O3|Outcome|Active MJ With 400 mg CBD|MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
128603|NCT01844687|O2|Outcome|Active MJ With 200 mg CBD|MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
128604|NCT01844687|O1|Outcome|Active MJ With 0 mg CBD|MJ cigarette with 5.3% THC content pretreated with 0 mg CBD
128605|NCT01844687|O8|Outcome|Inactive MJ With 800 mg CBD|MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
128606|NCT01844687|O7|Outcome|Inactive MJ With 400 mg CBD|MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
128607|NCT01844687|O6|Outcome|Inactive MJ With 200 mg CBD|MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
128608|NCT01844687|O5|Outcome|Inactive MJ With 0 mg CBD|MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
128609|NCT01844687|O4|Outcome|Active MJ With 800 mg CBD|MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
128610|NCT01844687|O3|Outcome|Active MJ With 400 mg CBD|MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
128611|NCT01844687|O2|Outcome|Active MJ With 200 mg CBD|MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
128612|NCT01844687|O1|Outcome|Active MJ With 0 mg CBD|MJ cigarette with 5.3% THC content pretreated with 0 mg CBD
128613|NCT01844687|O8|Outcome|Inactive MJ With 800 mg CBD|MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
128614|NCT01844687|O7|Outcome|Inactive MJ With 400 mg CBD|MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
128615|NCT01844687|O6|Outcome|Inactive MJ With 200 mg CBD|MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
128616|NCT01844687|O5|Outcome|Inactive MJ With 0 mg CBD|MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
128617|NCT01844687|O4|Outcome|Active MJ With 800 mg CBD|MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
128618|NCT01844687|O3|Outcome|Active MJ With 400 mg CBD|MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
128619|NCT01844687|O2|Outcome|Active MJ With 200 mg CBD|MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
128620|NCT01844687|O1|Outcome|Active MJ With 0 mg CBD|a placebo comparator measuring the effect of CBD on the strength of effects of smoking 5.30% THC cannabis cigarettes
128621|NCT01844687|O8|Outcome|Inactive MJ With 800 mg CBD|MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
128622|NCT01844687|O7|Outcome|Inactive MJ With 400 mg CBD|MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
128623|NCT01844687|O6|Outcome|Inactive MJ With 200 mg CBD|MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
128624|NCT01844687|O5|Outcome|Inactive MJ With 0 mg CBD|MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
128625|NCT01844687|O4|Outcome|Active MJ With 800 mg CBD|MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
128626|NCT01844687|O3|Outcome|Active MJ With 400 mg CBD|MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
128627|NCT01844687|O2|Outcome|Active MJ With 200 mg CBD|MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
128628|NCT01844687|O1|Outcome|Active MJ With 0 mg CBD|a placebo comparator measuring the effect of CBD on liking the effects of smoking 5.30% THC cannabis cigarettes
128629|NCT01844687|O8|Outcome|Inactive MJ With 800 mg CBD|MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
128630|NCT01844687|O7|Outcome|Inactive MJ With 400 mg CBD|MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
128631|NCT01844687|O6|Outcome|Inactive MJ With 200 mg CBD|MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
128632|NCT01844687|O5|Outcome|Inactive MJ With 0 mg CBD|MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
128633|NCT01844687|O4|Outcome|Active MJ With 800 mg CBD|MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
128634|NCT01844687|O3|Outcome|Active MJ With 400 mg CBD|MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
128635|NCT01844687|O2|Outcome|Active MJ With 200 mg CBD|MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
128636|NCT01844687|O1|Outcome|Active Marijuana (MJ) With 0 mg Cannabidiol (CBD)|a placebo comparator measuring the effect of cannabidiol (CBD) on moods produced by smoking 5.30% tetrahydrocannabinol (THC) cannabis cigarettes
128637|NCT01844687|E8|Reported Event|Inactive MJ With 800 mg CBD|"31 subjects were tested with 800 mg CBD and Inactive MJ cigarette.~8 of the 31 study completers were given 800 mg of cannabidiol on one additional study visit to measure plasma concentrations of cannabidiol for up to 360 minutes after ingestion. No MJ cigarette was smoked during this session. Adverse events reported during this session are included here."
128638|NCT01844687|E7|Reported Event|Inactive MJ With 400 mg CBD|31 subjects were tested with 400 mg CBD and an inactive marijuana cigarette.
128639|NCT01844687|E6|Reported Event|Inactive MJ With 200 mg CBD|31 subjects were tested with 0 mg CBD and an inactive MJ cigarette.
128640|NCT01844687|E5|Reported Event|Inactive MJ With 0 mg CBD|31 subjects were tested with 0 mg CBD and an inactive MJ cigarette.
128641|NCT01844687|E4|Reported Event|Active MJ With 800 mg CBD|31 subjects were tested with 800 mg CBD and an active MJ cigarette.
128642|NCT01844687|E3|Reported Event|Active MJ With 400 mg CBD|31 subjects were tested with 400 mg CBD and an active marijuana cigarette.
128643|NCT01844687|E2|Reported Event|Active MJ With 200 mg CBD|31 subjects were tested with 200 mg CBD and an active marijuana cigarette.
128644|NCT01844687|E1|Reported Event|Active MJ With 0 mg CBD|31 subjects were tested with 0 mg CBD and an active marijuana cigarette.
128645|NCT01844531|B5|Baseline|Total|Total of all reporting groups
128646|NCT01844531|B4|Baseline|Empa5+Met500/ FDC Empa5/ Empa12.5+Met500/ FDC Empa12.5|Participants first received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). Oral administration.
128674|NCT01844531|O4|Outcome|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
129004|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
128647|NCT01844531|B3|Baseline|FDC Empa5/ Empa5+Met500/ FDC Empa12.5/ Empa12.5+Met500|Participants first received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets)Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). Oral administration.
128648|NCT01844531|B2|Baseline|Empa12.5+Met500/ FDC Empa12.5/ Empa5+Met500/ FDC Empa5|"Participants first received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC).~Oral administration."
128649|NCT01844531|B1|Baseline|FDC Empa12.5/ Empa12.5+Met500/ FDC Empa5/ Empa5+Met500|"Participants first received Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets).~Oral administration."
128650|NCT01844531|P4|Participant Flow|Empa5+Met500/ FDC Empa5/ Empa12.5+Met500/ FDC Empa12.5|Participants first received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). Oral administration.
128651|NCT01844531|P3|Participant Flow|FDC Empa5/ Empa5+Met500/ FDC Empa12.5/ Empa12.5+Met500|Participants first received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets)Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). Oral administration.
128652|NCT01844531|P2|Participant Flow|Empa12.5+Met500/ FDC Empa12.5/ Empa5+Met500/ FDC Empa5|Participants first received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). Oral administration.
128653|NCT01844531|P1|Participant Flow|FDC Empa12.5/ Empa12.5+Met500/ FDC Empa5/ Empa5+Met500|Participants first received Treatment T1 (12.5 mg empagliflozin/500 mg metformin Fixed Dose Combination (FDC)). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets). Oral administration.
128654|NCT01844531|O4|Outcome|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
128655|NCT01844531|O3|Outcome|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
128656|NCT01844531|O2|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
128657|NCT01844531|O1|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
128658|NCT01844531|O4|Outcome|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
128659|NCT01844531|O3|Outcome|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
128660|NCT01844531|O2|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
128661|NCT01844531|O1|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
128662|NCT01844531|O4|Outcome|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
128663|NCT01844531|O3|Outcome|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
128664|NCT01844531|O2|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
128665|NCT01844531|O1|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
128666|NCT01844531|O4|Outcome|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
128667|NCT01844531|O3|Outcome|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
128668|NCT01844531|O2|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
128669|NCT01844531|O1|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
128670|NCT01844531|O4|Outcome|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
128671|NCT01844531|O3|Outcome|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
128672|NCT01844531|O2|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
128673|NCT01844531|O1|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
128675|NCT01844531|O3|Outcome|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
128676|NCT01844531|O2|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
128677|NCT01844531|O1|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
128678|NCT01844531|E4|Reported Event|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
128679|NCT01844531|E3|Reported Event|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
128680|NCT01844531|E2|Reported Event|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
128681|NCT01844531|E1|Reported Event|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
128682|NCT01844518|B1|Baseline|SC Abatacept Ages 6 to 17|Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
128683|NCT01844518|P1|Participant Flow|SC Abatacept Ages 6 to 17|Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to the following weight-tiered dosing regimen: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
128684|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
128685|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
128686|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
128687|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered to 6 to 17 year old participants by prefilled syringe (PFS) once weekly
128688|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
128689|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
128690|NCT01844518|O3|Outcome|>=50 kg Dosing Group|Weight-tiered dosing group receiving 125 mg subcutaneous (SC) abatacept administered to 6 to 17 year old participants by prefilled syringe (PFS) once weekly
128691|NCT01844518|O2|Outcome|25 to <50 kg Dosing Group|Weight-tiered dosing group receiving 87.5 mg subcutaneous (SC) abatacept administered to 6 to 17 year old participants by prefilled syringe (PFS) once weekly
128692|NCT01844518|O1|Outcome|10 to <25 kg Dosing Group|Weight-tiered dosing group receiving 50 milligrams (mg) subcutaneous (SC) abatacept administered to 6 to 17 year old participants by prefilled syringe (PFS) once weekly
128693|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
128694|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered to 6 to 17 year old participants by prefilled syringe (PFS) once weekly
128695|NCT01844518|E1|Reported Event|SC Abatacept Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered to 6 to 17 year old participants by prefilled syringe (PFS) once weekly
128696|NCT01844505|B4|Baseline|Total|Total of all reporting groups
128697|NCT01844505|B3|Baseline|Ipilimumab|Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
128698|NCT01844505|B2|Baseline|Nivolumab + Ipilimumab|Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
128699|NCT01844505|B1|Baseline|Nivolumab|Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
128700|NCT01844505|P3|Participant Flow|Ipilimumab|Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
128701|NCT01844505|P2|Participant Flow|Nivolumab + Ipilimumab|Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
128702|NCT01844505|P1|Participant Flow|Nivolumab|Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
128703|NCT01844505|O3|Outcome|Ipilimumab|Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
128704|NCT01844505|O2|Outcome|Nivolumab + Ipilimumab|Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
128705|NCT01844505|O1|Outcome|Nivolumab|Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
128706|NCT01844505|O3|Outcome|Ipilimumab|Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
128748|NCT01844505|E3|Reported Event|IPILIMUMAB|Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
128707|NCT01844505|O2|Outcome|Nivolumab + Ipilimumab|Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
128708|NCT01844505|O1|Outcome|Nivolumab|Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
128709|NCT01844505|O3|Outcome|Ipilimumab|Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
128710|NCT01844505|O2|Outcome|Nivolumab + Ipilimumab|Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
128711|NCT01844505|O1|Outcome|Nivolumab|Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
128712|NCT01844505|O3|Outcome|Ipilimumab|Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
128713|NCT01844505|O2|Outcome|Nivolumab + Ipilimumab|Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
128714|NCT01844505|O1|Outcome|Nivolumab|Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
128715|NCT01844505|O3|Outcome|Ipilimumab|Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
128716|NCT01844505|O2|Outcome|Nivolumab + Ipilimumab|Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
128717|NCT01844505|O1|Outcome|Nivolumab|Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
128718|NCT01844505|O3|Outcome|Ipilimumab|Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
128719|NCT01844505|O2|Outcome|Nivolumab + Ipilimumab|Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
128720|NCT01844505|O1|Outcome|Nivolumab|Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
128721|NCT01844505|O3|Outcome|Ipilimumab|Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
128722|NCT01844505|O2|Outcome|Nivolumab + Ipilimumab|Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
128723|NCT01844505|O1|Outcome|Nivolumab|Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
128724|NCT01844505|O3|Outcome|Ipilimumab|Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
128725|NCT01844505|O2|Outcome|Nivolumab + Ipilimumab|Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
128726|NCT01844505|O1|Outcome|Nivolumab|Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
128727|NCT01844505|O3|Outcome|Ipilimumab|Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
128728|NCT01844505|O2|Outcome|Nivolumab + Ipilimumab|Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
128729|NCT01844505|O1|Outcome|Nivolumab|Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
128730|NCT01844505|O3|Outcome|Ipilimumab|Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
128731|NCT01844505|O2|Outcome|Nivolumab + Ipilimumab|Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
128732|NCT01844505|O1|Outcome|Nivolumab|Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
128733|NCT01844505|O3|Outcome|Ipilimumab|Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
128734|NCT01844505|O2|Outcome|Nivolumab + Ipilimumab|Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
128735|NCT01844505|O1|Outcome|Nivolumab|Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
128736|NCT01844505|O3|Outcome|Ipilimumab|Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
128737|NCT01844505|O2|Outcome|Nivolumab + Ipilimumab|Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
128738|NCT01844505|O1|Outcome|Nivolumab|Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
128739|NCT01844505|O3|Outcome|Ipilimumab|Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
128740|NCT01844505|O2|Outcome|Nivolumab + Ipilimumab|Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
128741|NCT01844505|O1|Outcome|Nivolumab|Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
128742|NCT01844505|O3|Outcome|Ipilimumab|Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
128743|NCT01844505|O2|Outcome|Nivolumab + Ipilimumab|Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
128744|NCT01844505|O1|Outcome|Nivolumab|Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
128745|NCT01844505|O3|Outcome|Ipilimumab|Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
128746|NCT01844505|O2|Outcome|Nivolumab + Ipilimumab|Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
128747|NCT01844505|O1|Outcome|Nivolumab|Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
157742|NCT01717989|O2|Outcome|March 2011|
128749|NCT01844505|E2|Reported Event|NIVOLUMAB+IPILIMUMAB|Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
128750|NCT01844505|E1|Reported Event|NIVOLUMAB|Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
128751|NCT01844479|B1|Baseline|All Study Participants|"The industry standard diabetic innersole will be used as the active comparator~Standard innersole~The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load."
128752|NCT01844479|P2|Participant Flow|Diabetic Foot Orthotic Followed by Standard Innersole|"The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
128753|NCT01844479|P1|Participant Flow|Standard Innersole Followed by DFO|"The industry standard diabetic innersole will be used as the active comparator~Standard innersole~DFO The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load."
128754|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
128755|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
128756|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
128757|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
128758|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
128759|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
128760|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
128761|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
128805|NCT01843972|B8|Baseline|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
128762|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
128763|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
128764|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
128765|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
128766|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
128767|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
128768|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
128769|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
128770|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
128771|NCT01844479|O1|Outcome|Standard Innersole|"The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
128772|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
128773|NCT01844479|O1|Outcome|Standard Innersole|"The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
128774|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
128775|NCT01844479|O1|Outcome|Standard Innersole|"The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
128803|NCT01843972|B10|Baseline|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
128804|NCT01843972|B9|Baseline|BI 691751 Tablet (Part II)|"single dose given as 1 tablet~BI 691751: 1 tablet (10 mg)"
128776|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
128777|NCT01844479|O1|Outcome|Standard Innersole|"The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
128778|NCT01844479|E2|Reported Event|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
128779|NCT01844479|E1|Reported Event|Standard Innersole|"The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
128780|NCT01844388|B3|Baseline|Total|Total of all reporting groups
128781|NCT01844388|B2|Baseline|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
128782|NCT01844388|B1|Baseline|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
128783|NCT01844388|P2|Participant Flow|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
128784|NCT01844388|P1|Participant Flow|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
128785|NCT01844388|O2|Outcome|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
128786|NCT01844388|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
128787|NCT01844388|O2|Outcome|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
128788|NCT01844388|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
128789|NCT01844388|O2|Outcome|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
128790|NCT01844388|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
128791|NCT01844388|E2|Reported Event|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
128792|NCT01844388|E1|Reported Event|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
128793|NCT01844206|B3|Baseline|Total|Total of all reporting groups
128794|NCT01844206|B2|Baseline|Epidural Saline|"Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.~Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg."
128795|NCT01844206|B1|Baseline|Epidural Morphine|"Group receiving 3mg epidural morphine, 24 hours after the initial dose~Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose."
128796|NCT01844206|P2|Participant Flow|Epidural Saline|"Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.~Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg."
128797|NCT01844206|P1|Participant Flow|Epidural Morphine|"Group receiving 3mg epidural morphine, 24 hours after the initial dose~Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose."
128798|NCT01844206|O2|Outcome|Epidural Saline|"Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.~Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg."
128799|NCT01844206|O1|Outcome|Epidural Morphine|"Group receiving 3mg epidural morphine, 24 hours after the initial dose~Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose."
128800|NCT01844206|E2|Reported Event|Epidural Saline|"Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.~Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg."
128801|NCT01844206|E1|Reported Event|Epidural Morphine|"Group receiving 3mg epidural morphine, 24 hours after the initial dose~Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose."
128802|NCT01843972|B11|Baseline|Total|Total of all reporting groups
157743|NCT01717989|O1|Outcome|December 2010|
128806|NCT01843972|B7|Baseline|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
128807|NCT01843972|B6|Baseline|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
128808|NCT01843972|B5|Baseline|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
128809|NCT01843972|B4|Baseline|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
128810|NCT01843972|B3|Baseline|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
128811|NCT01843972|B2|Baseline|BI 691751dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
128812|NCT01843972|B1|Baseline|Placebo (Part I)|"placebo solution~Placebo: placebo solution"
128813|NCT01843972|P10|Participant Flow|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
128814|NCT01843972|P9|Participant Flow|BI 691751 Tablet (Part II)|"single dose given as 1 tablet~BI 691751: 1 tablet (10 mg)"
128815|NCT01843972|P8|Participant Flow|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
128816|NCT01843972|P7|Participant Flow|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
128817|NCT01843972|P6|Participant Flow|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
128818|NCT01843972|P5|Participant Flow|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
128819|NCT01843972|P4|Participant Flow|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
128820|NCT01843972|P3|Participant Flow|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
128821|NCT01843972|P2|Participant Flow|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
128822|NCT01843972|P1|Participant Flow|Placebo (Part I)|"placebo solution~Placebo: placebo solution"
128823|NCT01843972|O8|Outcome|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
128824|NCT01843972|O7|Outcome|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
128825|NCT01843972|O6|Outcome|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
128826|NCT01843972|O5|Outcome|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
128827|NCT01843972|O4|Outcome|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
128828|NCT01843972|O3|Outcome|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
128829|NCT01843972|O2|Outcome|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
128830|NCT01843972|O1|Outcome|Placebo (Part I)|"placebo solution~Placebo: placebo solution"
128831|NCT01843972|O8|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
128832|NCT01843972|O7|Outcome|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
128833|NCT01843972|O6|Outcome|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
128834|NCT01843972|O5|Outcome|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
128835|NCT01843972|O4|Outcome|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
128836|NCT01843972|O3|Outcome|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
128837|NCT01843972|O2|Outcome|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
128838|NCT01843972|O1|Outcome|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
128839|NCT01843972|O8|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
128840|NCT01843972|O7|Outcome|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
128841|NCT01843972|O6|Outcome|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
128842|NCT01843972|O5|Outcome|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
128843|NCT01843972|O4|Outcome|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
128844|NCT01843972|O3|Outcome|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
128845|NCT01843972|O2|Outcome|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
128846|NCT01843972|O1|Outcome|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
128847|NCT01843972|O10|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
128848|NCT01843972|O9|Outcome|BI 691751 Tablet Poor Metabolizers (Part II)|single dose given as 1 tablet; poor metabolizers; BI 691751: 1 tablet (10 mg)
128849|NCT01843972|O8|Outcome|BI 691751 Tablet Extensive Metabolizers (Part II)|single dose given as 1 tablet; extensive metabolizers; BI 691751: 1 tablet (10 mg)
128850|NCT01843972|O7|Outcome|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
128851|NCT01843972|O6|Outcome|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
128852|NCT01843972|O5|Outcome|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
128853|NCT01843972|O4|Outcome|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
128854|NCT01843972|O3|Outcome|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
128855|NCT01843972|O2|Outcome|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
128856|NCT01843972|O1|Outcome|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
128857|NCT01843972|O8|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
128858|NCT01843972|O7|Outcome|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
128859|NCT01843972|O6|Outcome|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
128860|NCT01843972|O5|Outcome|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
128861|NCT01843972|O4|Outcome|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
128862|NCT01843972|O3|Outcome|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
128863|NCT01843972|O2|Outcome|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
128864|NCT01843972|O1|Outcome|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
128865|NCT01843972|O8|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
128866|NCT01843972|O7|Outcome|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
128867|NCT01843972|O6|Outcome|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
128868|NCT01843972|O5|Outcome|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
128869|NCT01843972|O4|Outcome|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
128870|NCT01843972|O3|Outcome|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
128871|NCT01843972|O2|Outcome|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
128872|NCT01843972|O1|Outcome|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
128873|NCT01843972|O3|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
128874|NCT01843972|O2|Outcome|BI 691751 Tablet Poor Metabolizers (Part II)|single dose given as 1 tablet; poor metabolizers; BI 691751: 1 tablet (10 mg)
128875|NCT01843972|O1|Outcome|BI 691751 Tablet Extensive Metabolizers (Part II)|single dose given as 1 tablet; extensive metabolizers; BI 691751: 1 tablet (10 mg)
128876|NCT01843972|O3|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
128877|NCT01843972|O2|Outcome|BI 691751 Tablet Poor Metabolizers (Part II)|"single dose given as 1 tablet; poor metabolizers;~BI 691751: 1 tablet (10 mg)"
128878|NCT01843972|O1|Outcome|BI 691751 Tablet Extensive Metabolizers (Part II)|"single dose given as 1 tablet; extensive metabolizers;~BI 691751: 1 tablet (10 mg)"
128879|NCT01843972|E10|Reported Event|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
128880|NCT01843972|E9|Reported Event|BI 691751 Tablet (Part II)|"single dose given as 1 tablet~BI 691751: 1 tablet (10 mg)"
128881|NCT01843972|E8|Reported Event|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
128882|NCT01843972|E7|Reported Event|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
128883|NCT01843972|E6|Reported Event|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
128884|NCT01843972|E5|Reported Event|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
128885|NCT01843972|E4|Reported Event|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
128886|NCT01843972|E3|Reported Event|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
128887|NCT01843972|E2|Reported Event|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
128890|NCT01843933|B2|Baseline|Intervention: Standard Monitoring and Capnography Viewable|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, and the screen will be viewable by staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data.
128891|NCT01843933|B1|Baseline|Control: Standard Monitoring and Blinded to Capnography|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, but the screen out of site of staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data but staff will be blinded to the monitor output.
128892|NCT01843933|P2|Participant Flow|Intervention: Standard Monitoring and Capnography Viewable|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, and the screen will be viewable by staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data.
128893|NCT01843933|P1|Participant Flow|Control: Standard Monitoring and Blinded to Capnography|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, but the screen out of site of staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data but staff will be blinded to the monitor output.
128894|NCT01843933|O2|Outcome|Intervention: Standard Monitoring and Capnography Viewable|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, and the screen will be viewable by staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data.
128895|NCT01843933|O1|Outcome|Control: Standard Monitoring and Blinded to Capnography|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, but the screen out of site of staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data but staff will be blinded to the monitor output.
128896|NCT01843933|E2|Reported Event|Intervention: Standard Monitoring and Capnography Viewable|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, and the screen will be viewable by staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data.
128897|NCT01843933|E1|Reported Event|Control: Standard Monitoring and Blinded to Capnography|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, but the screen out of site of staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data but staff will be blinded to the monitor output.
128898|NCT01843920|B3|Baseline|Total|Total of all reporting groups
128899|NCT01843920|B2|Baseline|Post Surgery With Glaucoma Drops|"This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.~Timolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
128900|NCT01843920|B1|Baseline|Post Surgery Without Glaucoma Drops|"This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
128901|NCT01843920|P2|Participant Flow|Post Surgery With Glaucoma Drops|"This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.~Timolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
128902|NCT01843920|P1|Participant Flow|Post Surgery Without Glaucoma Drops|"This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
128903|NCT01843920|O2|Outcome|Post Surgery With Glaucoma Drops|"This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.~Timolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
128904|NCT01843920|O1|Outcome|Post Surgery Without Glaucoma Drops|"This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
128905|NCT01843920|O2|Outcome|Post Surgery With Glaucoma Drops|"This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.~Timolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
129005|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
129006|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
128906|NCT01843920|O1|Outcome|Post Surgery Without Glaucoma Drops|"This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
128907|NCT01843920|E2|Reported Event|Post Surgery With Glaucoma Drops|"This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.~Timolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
128908|NCT01843920|E1|Reported Event|Post Surgery Without Glaucoma Drops|"This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
128909|NCT01843777|B3|Baseline|Total|Total of all reporting groups
128910|NCT01843777|B2|Baseline|Treatment|"The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing.~Treatment: motivational interviewing"
128911|NCT01843777|B1|Baseline|Standard-of-Care|"The standard-of-care control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids.~Standard-of-Care: the standard of care in audiologic practice"
128912|NCT01843777|P2|Participant Flow|Treatment|"The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing.~Treatment: motivational interviewing"
128913|NCT01843777|P1|Participant Flow|Standard-of-Care|"The standard-of-care control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids.~Standard-of-Care: the standard of care in audiologic practice"
128914|NCT01843777|O2|Outcome|Treatment|"The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing.~Treatment: motivational interviewing"
128915|NCT01843777|O1|Outcome|Standard-of-Care|"The standard-of-care control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids.~Standard-of-Care: the standard of care in audiologic practice"
128916|NCT01843777|O2|Outcome|Treatment|"The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing.~Treatment: motivational interviewing"
128917|NCT01843777|O1|Outcome|Standard-of-Care|"The standard-of-care control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids.~Standard-of-Care: the standard of care in audiologic practice"
128918|NCT01843777|E2|Reported Event|Treatment|"The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing.~Treatment: motivational interviewing"
128919|NCT01843777|E1|Reported Event|Standard-of-Care|"The standard-of-care control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids.~Standard-of-Care: the standard of care in audiologic practice"
128920|NCT01843673|B1|Baseline|Diagnostic (Imaging Technology)|"Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.~computed tomography: Undergo FBCT~cone-beam computed tomography: Undergo dual CBCT~radiography: Undergo 2-D x-ray with Varian kV OBI~radiography: Undergo 2-D x-ray with Brain Lab ExacTrac~radiography: Undergo 2-D x-ray with Varian MV OBI~electronic portal imaging: Undergo EPID imaging~image-guided adaptive radiation therapy: Undergo IGART"
128921|NCT01843673|P1|Participant Flow|Diagnostic (Imaging Technology)|"Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.~computed tomography: Undergo FBCT cone-beam computed tomography: Undergo dual CBCT radiography: Undergo 2-D x-ray with Varian kV OBI radiography: Undergo 2-D x-ray with Brain Lab ExacTrac radiography: Undergo 2-D x-ray with Varian MV OBI electronic portal imaging: Undergo EPID imaging image-guided adaptive radiation therapy: Undergo IGART"
128922|NCT01843673|O3|Outcome|Oblique Brainlab ExacTrac Images|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure ExacTrac gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
128923|NCT01843673|O2|Outcome|Varian CBCT (Cone Beam CT) Imaging|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure CBCT gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
157744|NCT01717989|O5|Outcome|December 2011|
128924|NCT01843673|O1|Outcome|Orthogonal Varian kV OBI Image|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure OBI gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
128925|NCT01843673|O3|Outcome|Oblique Brainlab ExacTrac Images|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure ExacTrac gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
128926|NCT01843673|O2|Outcome|Varian CBCT (Cone Beam CT) Imaging|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure CBCT gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
128927|NCT01843673|O1|Outcome|Orthogonal Varian kV OBI Image|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure OBI gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
128928|NCT01843673|O3|Outcome|Oblique Brainlab ExacTrac Images|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure ExacTrac gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
128929|NCT01843673|O2|Outcome|Varian CBCT (Cone Beam CT) Imaging|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure CBCT gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
128930|NCT01843673|O1|Outcome|Orthogonal Varian kV OBI Image|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure OBI gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
128931|NCT01843673|E1|Reported Event|Diagnostic (Imaging Technology)|"Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.~computed tomography: Undergo FBCT~cone-beam computed tomography: Undergo dual CBCT~radiography: Undergo 2-D x-ray with Varian kV OBI~radiography: Undergo 2-D x-ray with Brain Lab ExacTrac~radiography: Undergo 2-D x-ray with Varian MV OBI~electronic portal imaging: Undergo EPID imaging~image-guided adaptive radiation therapy: Undergo IGART"
128932|NCT01843660|B1|Baseline|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
128933|NCT01843660|P1|Participant Flow|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
128934|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
128935|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
128936|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
128937|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
128938|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
128939|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
128940|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
128941|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
128942|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
128943|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
129007|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
157745|NCT01717989|O4|Outcome|September 2011|
128944|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
128945|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
128946|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
128947|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
128948|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
128949|NCT01843660|E1|Reported Event|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
128950|NCT01843465|B1|Baseline|Cryoablation of Atrial Fibrillation|Maneuvers for documenting the disconnection :
128951|NCT01843465|P1|Participant Flow|Cryoablation of Atrial Fibrillation|"All patients underwent cryoballoon ablation of atrial fibrillation using the Achieve 20mm catheter for real-time documentation of PV potentials.~According to the maneuvers for documenting the disconnection , 4 PV types were defined:~Type 1 - Achieve allowing documentation of PV disconnection in the standard position.~Type 2 - Need of backward/proximal displacement of the Achieve catheter to display PV potentials during cryoenergy application.~Type 3 - No possibility of clear documentation of PV potentials, but capture of PV with pacing Type 4 - no real-time documentation of PV disconnection"
128952|NCT01843465|O1|Outcome|Cryoablation of Atrial Fibrillation|"Maneuvers for documenting the disconnection :~Type 1 pulmonary veins Type 2 pulmonary veins Type 3 pulmonary veins Type 4 pulmonary veins"
128953|NCT01843465|E1|Reported Event|Cryoablation of Atrial Fibrillation|"Maneuvers for documenting the disconnection :~Type 1 pulmonary veins Type 2 pulmonary veins Type 3 pulmonary veins Type 4 pulmonary veins"
128954|NCT01843374|B3|Baseline|Total|Total of all reporting groups
128955|NCT01843374|B2|Baseline|PLACEBO|Placebo.
128956|NCT01843374|B1|Baseline|TREMELIMUMAB|TREMELIMUMAB 10 mg/kg
128957|NCT01843374|P2|Participant Flow|TREMELIMUMAB|TREMELIMUMAB 10 mg/kg
128958|NCT01843374|P1|Participant Flow|PLACEBO|Placebo.
128959|NCT01843374|O2|Outcome|TREMELIMUMAB|Tremelimumab 10mg/kg
128960|NCT01843374|O1|Outcome|PLACEBO|Placebo.
128961|NCT01843374|O2|Outcome|TREMELIMUMAB|Tremelimumab 10mg/kg
128962|NCT01843374|O1|Outcome|PLACEBO|Placebo.
128963|NCT01843374|O2|Outcome|PLACEBO|Placebo.
128964|NCT01843374|O1|Outcome|TREMELIMUMAB|Tremelimumab 10mg/kg
128965|NCT01843374|O2|Outcome|PLACEBO|Placebo.
128966|NCT01843374|O1|Outcome|TREMELIMUMAB|Tremelimumab 10mg/kg
128967|NCT01843374|O2|Outcome|PLACEBO|Placebo.
128968|NCT01843374|O1|Outcome|TREMELIMUMAB|Tremelimumab 10mg/kg
128969|NCT01843374|O2|Outcome|PLACEBO|Placebo.
128970|NCT01843374|O1|Outcome|TREMELIMUMAB|Tremelimumab 10mg/kg
128971|NCT01843374|O2|Outcome|PLACEBO|Placebo.
128972|NCT01843374|O1|Outcome|TREMELIMUMAB|Tremelimumab 10mg/kg
128973|NCT01843374|O2|Outcome|PLACEBO|Placebo.
128974|NCT01843374|O1|Outcome|TREMELIMUMAB|Tremelimumab 10mg/kg
128975|NCT01843374|O2|Outcome|PLACEBO|Placebo.
128976|NCT01843374|O1|Outcome|TREMELIMUMAB|Tremelimumab 10mg/kg
128977|NCT01843374|O2|Outcome|TREMELIMUMAB|TREMELIMUMAB 10 mg/kg
128978|NCT01843374|O1|Outcome|PLACEBO|Placebo.
128979|NCT01843374|E2|Reported Event|TREMELIMUMAB|Tremelimumab 10mg/kg
128980|NCT01843374|E1|Reported Event|PLACEBO|Placebo.
128981|NCT01843348|B4|Baseline|Total|Total of all reporting groups
128982|NCT01843348|B3|Baseline|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
128983|NCT01843348|B2|Baseline|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
128984|NCT01843348|B1|Baseline|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
128985|NCT01843348|P3|Participant Flow|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
128986|NCT01843348|P2|Participant Flow|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
128987|NCT01843348|P1|Participant Flow|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
128988|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
128989|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
128990|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
128991|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
128992|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
128993|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
128994|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
128995|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
128996|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
128997|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
128998|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
128999|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
129000|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
129001|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
157746|NCT01717989|O3|Outcome|June 2011|
129008|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
129009|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
129010|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
129011|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
129012|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
129013|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
129014|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
129015|NCT01843348|O5|Outcome|CycA+Certican -Tac+MPA - Difference Between Groups|
129016|NCT01843348|O4|Outcome|Tac+Certican - Tac+MPA - Difference Between Groups|
129017|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
129018|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
129019|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
129020|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
129021|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
129022|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
129023|NCT01843348|E3|Reported Event|CycA+Certican|CycA+Certican
129024|NCT01843348|E2|Reported Event|Tac+Certican|Tac+Certican
129025|NCT01843348|E1|Reported Event|Tac+MPA|Tac+MPA
129026|NCT01843205|B1|Baseline|Completing Participants|All subjects who completed the study.
129027|NCT01843205|P2|Participant Flow|Buspirone Then Placebo|Subjects were maintained on 45 mg buspirone daily for 7 days, then they were crossed over to placebo for 7 days.
129028|NCT01843205|P1|Participant Flow|Placebo Then Buspirone|Subjects were maintained on placebo for 7 days, then they were crossed over to 45 mg buspirone daily for 7 days.
129029|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129030|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129031|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129032|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129033|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129034|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129035|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129036|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129037|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129038|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129039|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129040|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129041|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129042|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129043|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129044|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129045|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129046|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129047|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129048|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129049|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129050|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129051|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129052|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129053|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129054|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129055|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129056|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129057|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129058|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129059|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129060|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129061|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129062|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129063|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129064|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129065|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129066|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129067|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129068|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129069|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129070|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129071|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129072|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129073|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129074|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129075|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129076|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129077|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129078|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129079|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129080|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129081|NCT01843205|O2|Outcome|Buspirone|Subjects were maintained on 45 mg buspirone daily for 7 days.
129082|NCT01843205|O1|Outcome|Placebo|Subjects were maintained on placebo for 7 days.
129083|NCT01843205|E2|Reported Event|Buspirone|All completing subjects who received buspirone maintenance.
129084|NCT01843205|E1|Reported Event|Placebo|All completing subjects who received placebo maintenance.
129085|NCT01843192|B4|Baseline|Total|Total of all reporting groups
129086|NCT01843192|B3|Baseline|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
129087|NCT01843192|B2|Baseline|Lobectomy|Subjects undergoing VATS lobectomy
129088|NCT01843192|B1|Baseline|Wedge Resection|Subjects undergoing VATS wedge resection
129089|NCT01843192|P3|Participant Flow|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
129090|NCT01843192|P2|Participant Flow|Lobectomy|Subjects undergoing VATS lobectomy
129091|NCT01843192|P1|Participant Flow|Wedge Resection|Subjects undergoing VATS wedge resection
129092|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
129093|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
129094|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
129095|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
129096|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
129097|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
129098|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
129099|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
129100|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
129101|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
129102|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
129103|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
129104|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
129105|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
129106|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
129107|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
129108|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
129109|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
129110|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
129111|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
129112|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
129113|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
129114|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
129115|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
129116|NCT01843192|E3|Reported Event|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
129117|NCT01843192|E2|Reported Event|Lobectomy|Subjects undergoing VATS lobectomy
129118|NCT01843192|E1|Reported Event|Wedge Resection|Subjects undergoing VATS wedge resection
129119|NCT01842958|B3|Baseline|Total|Total of all reporting groups
129120|NCT01842958|B2|Baseline|4.1 mm Implant Diameter|Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
129121|NCT01842958|B1|Baseline|3.3 mm Implant Diameter|Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
129122|NCT01842958|P2|Participant Flow|4.1 mm Implant Diameter|Placement of a Straumann Bone Level Implant, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
129123|NCT01842958|P1|Participant Flow|3.3 mm Implant Diameter|Placement of a Straumann Bone Level Implant, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
129124|NCT01842958|O2|Outcome|4.1 mm Implant Diameter|Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
129125|NCT01842958|O1|Outcome|3.3 mm Implant Diameter|Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
129126|NCT01842958|O2|Outcome|4.1 mm Implant Diameter|Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
129127|NCT01842958|O1|Outcome|3.3 mm Implant Diameter|Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
129128|NCT01842958|O2|Outcome|4.1 mm Implant Diameter|Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
129129|NCT01842958|O1|Outcome|3.3 mm Implant Diameter|Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
157747|NCT01717989|O2|Outcome|March 2011|
129130|NCT01842958|O2|Outcome|4.1 mm Implant Diameter|Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
129131|NCT01842958|O1|Outcome|3.3 mm Implant Diameter|Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
129132|NCT01842958|O2|Outcome|4.1 mm Implant Diameter|Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
129133|NCT01842958|O1|Outcome|3.3 mm Implant Diameter|Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
129134|NCT01842958|O2|Outcome|4.1 mm Implant Diameter|Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
129135|NCT01842958|O1|Outcome|3.3 mm Implant Diameter|Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
129136|NCT01842958|O2|Outcome|4.1 mm Implant Diameter|Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
129137|NCT01842958|O1|Outcome|3.3 mm Implant Diameter|Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
129138|NCT01842958|E2|Reported Event|4.1 mm Implant Diameter|Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
129139|NCT01842958|E1|Reported Event|3.3 mm Implant Diameter|Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
129140|NCT01842906|B3|Baseline|Total|Total of all reporting groups
129141|NCT01842906|B2|Baseline|Control|"A visibly identical sham device that does not provide positive end expiratory pressure.~Control: Sham device without EPAP"
129142|NCT01842906|B1|Baseline|Theravent|"A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.~Theravent: nasal EPAP device"
129143|NCT01842906|P2|Participant Flow|Control|"A visibly identical sham device that does not provide positive end expiratory pressure.~Control: Sham device without EPAP"
129144|NCT01842906|P1|Participant Flow|Theravent|"A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.~Theravent: nasal EPAP device"
129145|NCT01842906|O2|Outcome|Theravent|"A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.~Theravent: nasal EPAP device"
129146|NCT01842906|O1|Outcome|Control|"A visibly identical sham device that does not provide positive end expiratory pressure.~Control: Sham device without EPAP"
129147|NCT01842906|O2|Outcome|Theravent|"A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.~Theravent: nasal EPAP device"
129148|NCT01842906|O1|Outcome|Control|"A visibly identical sham device that does not provide positive end expiratory pressure.~Control: Sham device without EPAP"
129149|NCT01842906|O2|Outcome|Theravent|"A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.~Theravent: nasal EPAP device"
129150|NCT01842906|O1|Outcome|Control|"A visibly identical sham device that does not provide positive end expiratory pressure.~Control: Sham device without EPAP"
129151|NCT01842906|O2|Outcome|Theravent|"A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.~Theravent: nasal EPAP device"
129152|NCT01842906|O1|Outcome|Control|"A visibly identical sham device that does not provide positive end expiratory pressure.~Control: Sham device without EPAP"
129153|NCT01842906|E2|Reported Event|Theravent|"A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.~Theravent: nasal EPAP device"
129154|NCT01842906|E1|Reported Event|Control|"A visibly identical sham device that does not provide positive end expiratory pressure.~Control: Sham device without EPAP"
129155|NCT01842841|B1|Baseline|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
129156|NCT01842841|P1|Participant Flow|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 units per kilogram (U/kg), every other week (EOW) administered as an intravenous (IV) infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
129157|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
129158|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
129159|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
129160|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
129161|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
129162|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
129163|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
129164|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
157748|NCT01717989|O1|Outcome|December 2010|
129165|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
129166|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
129167|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
129168|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
129169|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
129170|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
129171|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
129172|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
129173|NCT01842841|E1|Reported Event|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
129174|NCT01842789|B3|Baseline|Total|Total of all reporting groups
129175|NCT01842789|B2|Baseline|Acessa Procedure With TAG|"Acessa Procedure with Targeting Animation Guidance~Acessa Procedure: Acessa Procedure"
129176|NCT01842789|B1|Baseline|Acessa Procedure w/o TAG|"Acessa Procedure without the use of Targeting Animation Guidance~Acessa Procedure: Acessa Procedure"
129177|NCT01842789|P2|Participant Flow|Acessa Procedure With TAG|"Acessa Procedure with Targeting Animation Guidance~Acessa Procedure: Acessa Procedure"
129178|NCT01842789|P1|Participant Flow|Acessa Procedure w/o TAG|"Acessa Procedure without the use of Targeting Animation Guidance~Acessa Procedure: Acessa Procedure"
129179|NCT01842789|O2|Outcome|Acessa Procedure With TAG|"Acessa Procedure with Targeting Animation Guidance~Acessa Procedure: Acessa Procedure"
129180|NCT01842789|O1|Outcome|Acessa Procedure w/o TAG|"Acessa Procedure without the use of Targeting Animation Guidance~Acessa Procedure: Acessa Procedure"
129181|NCT01842789|O2|Outcome|Acessa Procedure With TAG|"Acessa Procedure with Targeting Animation Guidance~Acessa Procedure: Acessa Procedure"
129182|NCT01842789|O1|Outcome|Acessa Procedure w/o TAG|"Acessa Procedure without the use of Targeting Animation Guidance~Acessa Procedure: Acessa Procedure"
129183|NCT01842789|O1|Outcome|Acessa Procedure With TAG|"Acessa Procedure with Targeting Animation Guidance~Acessa Procedure: Acessa Procedure"
129184|NCT01842789|E2|Reported Event|Acessa Procedure With TAG|"Acessa Procedure with Targeting Animation Guidance~Acessa Procedure: Acessa Procedure"
129185|NCT01842789|E1|Reported Event|Acessa Procedure w/o TAG|"Acessa Procedure without the use of Targeting Animation Guidance~Acessa Procedure: Acessa Procedure"
129186|NCT01842646|B1|Baseline|Experimental: PF-04449913 Treatment|Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
129187|NCT01842646|P1|Participant Flow|Experimental: PF-04449913 Treatment|Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
129188|NCT01842646|O1|Outcome|Experimental: PF-04449913 Treatment|Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
129189|NCT01842646|O1|Outcome|Experimental: PF-04449913 Treatment|Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
129190|NCT01842646|O1|Outcome|Experimental: PF-04449913 Treatment|Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
129191|NCT01842646|E1|Reported Event|Experimental: PF-04449913 Treatment|Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
129192|NCT01842633|B4|Baseline|Total|Total of all reporting groups
129193|NCT01842633|B3|Baseline|Placebo Caplets|Participants were administered with four placebo caplets orally with 8 ounces of water
129194|NCT01842633|B2|Baseline|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus 2 placebo caplets orally with 8 ounces of water
129195|NCT01842633|B1|Baseline|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus 2 placebo caplets orally with 8 ounces of water
129196|NCT01842633|P3|Participant Flow|Placebo Caplets|Participants were administered with four placebo caplets with 8 ounces of water
129197|NCT01842633|P2|Participant Flow|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus 2 placebo caplets orally with 8 ounces of water
129198|NCT01842633|P1|Participant Flow|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65milligram (mg) plus 2 placebo caplets orally with 8 ounces of water
129199|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
129200|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
129286|NCT01842464|P1|Participant Flow|Anterior Sacro-Spinos Support|Anterior Sacro-Spinous Support :
129201|NCT01842633|O1|Outcome|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
129202|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
129203|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
129204|NCT01842633|O1|Outcome|Paracetamol/Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
129205|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
129206|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
129207|NCT01842633|O1|Outcome|Paracetamol/ Caffiene Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
129208|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
129209|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
129210|NCT01842633|O1|Outcome|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
129211|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
129212|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
129213|NCT01842633|O1|Outcome|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
129214|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
129215|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
129216|NCT01842633|O1|Outcome|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
129217|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
129218|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
129219|NCT01842633|O1|Outcome|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
129220|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
129221|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
129222|NCT01842633|O1|Outcome|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
129223|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
129224|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
129225|NCT01842633|O1|Outcome|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
129226|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
129227|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
129228|NCT01842633|O1|Outcome|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
129229|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
129230|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
129231|NCT01842633|O1|Outcome|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
129232|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
129233|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
129234|NCT01842633|O1|Outcome|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
129235|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
129236|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
129237|NCT01842633|O1|Outcome|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
129238|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
129239|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
129287|NCT01842464|O1|Outcome|Anterior Sacro-Spinos Support|Anterior Sacro-Spinous Support :
129240|NCT01842633|O1|Outcome|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
129241|NCT01842633|E3|Reported Event|Placebo Caplets|Participants were administered with four placebo caplets orally with 8 ounce of water
129242|NCT01842633|E2|Reported Event|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus 2 placebo caplets orally with 8 ounce of water
129243|NCT01842633|E1|Reported Event|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus 2 placebo caplets orally with 8 ounce of water
129244|NCT01842620|B1|Baseline|Total Population|Eligible participants received single oral metformin (OXEMET) 1000 mg for one day and single oral metformin (GLAFORNIL) 500 mg BID for one day in each of the two treatment periods in a randomized manner. Participants had a washout period of 7 days between two treatment periods and were followed up to 7 days after the last dose of the study drug
129245|NCT01842620|P2|Participant Flow|GLAFORNIL Then OXEMET|Eligible participants received single oral metformin (GLAFORNIL) 500 mg BID for one day in Treatment period 1 and was followed by 7 days washout period. Participants then received single oral metformin (OXEMET) 1000 mg for one day in Treatment period 2, followed by 7 days follow-up period. The two treatment periods were separated by a washout period of 7 days and participants received the study drugs in a randomized manner.
129246|NCT01842620|P1|Participant Flow|OXEMET Then GLAFORNIL|Eligible participants received single oral metformin (OXEMET) 1000 milligrams (mg) for one day in Treatment period 1 and was followed by 7 days washout period. Participants then received single oral metformin (GLAFORNIL) 500 mg twice daily (BID) for one day in Treatment period 2, followed by 7 days follow-up period. The two treatment periods were separated by a washout period of 7 days and participants received the study drugs in a randomized manner.
129247|NCT01842620|O2|Outcome|GLAFORNIL 1000 mg BID|Eligible participants received single oral metformin (GLAFORNIL) 500 mg BID for one day each in each of the two treatment periods in a randomized manner. Participants had a washout period of 7 days between two treatment periods and were followed up to 7 days after the last dose of the study drug.
129248|NCT01842620|O1|Outcome|OXEMET 1000 mg Once Daily|Eligible participants received single oral metformin (OXEMET) 1000 mg for one day in each of the two treatment periods in a randomized manner. Participants had a washout period of 7 days between two treatment periods and were followed up to 7 days after the last dose of the study drug.
129249|NCT01842620|O2|Outcome|GLAFORNIL 1000 mg BID|Eligible participants received single oral metformin (GLAFORNIL) 500 mg BID for one day each in each of the two treatment periods in a randomized manner. Participants had a washout period of 7 days between two treatment periods and were followed up to 7 days after the last dose of the study drug.
129250|NCT01842620|O1|Outcome|OXEMET 1000 mg Once Daily|Eligible participants received single oral metformin (OXEMET) 1000 mg for one day in each of the two treatment periods in a randomized manner. Participants had a washout period of 7 days between two treatment periods and were followed up to 7 days after the last dose of the study drug.
129251|NCT01842620|O2|Outcome|GLAFORNIL 1000 mg BID|Eligible participants received single oral metformin (GLAFORNIL) 500 mg BID for one day each in each of the two treatment periods in a randomized manner. Participants had a washout period of 7 days between two treatment periods and were followed up to 7 days after the last dose of the study drug.
129252|NCT01842620|O1|Outcome|OXEMET 1000 mg Once Daily|Eligible participants received single oral metformin (OXEMET) 1000 mg for one day in each of the two treatment periods in a randomized manner. Participants had a washout period of 7 days between two treatment periods and were followed up to 7 days after the last dose of the study drug.
129253|NCT01842620|O2|Outcome|GLAFORNIL 1000 mg BID|Eligible participants received single oral metformin (GLAFORNIL) 500 mg BID for one day each in each of the two treatment periods in a randomized manner. Participants had a washout period of 7 days between two treatment periods and were followed up to 7 days after the last dose of the study drug.
129254|NCT01842620|O1|Outcome|OXEMET 1000 mg Once Daily|Eligible participants received single oral metformin (OXEMET) 1000 mg for one day in each of the two treatment periods in a randomized manner. Participants had a washout period of 7 days between two treatment periods and were followed up to 7 days after the last dose of the study drug.
129255|NCT01842620|O2|Outcome|GLAFORNIL 1000 mg BID|Eligible participants received single oral metformin (GLAFORNIL) 500 mg BID for one day each in each of the two treatment periods in a randomized manner. Participants had a washout period of 7 days between two treatment periods and were followed up to 7 days after the last dose of the study drug.
129256|NCT01842620|O1|Outcome|OXEMET 1000 mg Once Daily|Eligible participants received single oral metformin (OXEMET) 1000 mg for one day in each of the two treatment periods in a randomized manner. Participants had a washout period of 7 days between two treatment periods and were followed up to 7 days after the last dose of the study drug.
129257|NCT01842620|O2|Outcome|GLAFORNIL 1000 mg BID|Eligible participants received single oral metformin (GLAFORNIL) 500 mg BID for one day each in each of the two treatment periods in a randomized manner. Participants had a washout period of 7 days between two treatment periods and were followed up to 7 days after the last dose of the study drug.
129258|NCT01842620|O1|Outcome|OXEMET 1000 mg Once Daily|Eligible participants received single oral metformin (OXEMET) 1000 mg for one day in each of the two treatment periods in a randomized manner. Participants had a washout period of 7 days between two treatment periods and were followed up to 7 days after the last dose of the study drug.
129259|NCT01842620|E2|Reported Event|GLAFORNIL 1000 mg BID|Eligible participants received single oral metformin (GLAFORNIL) 500 milligrams (mg) twice daily (BID) for one day each in each of the two treatment periods in a randomized manner. Participants had a washout period of 7 days between two treatment periods and were followed up to 7 days after the last dose of the study drug.
129260|NCT01842620|E1|Reported Event|OXEMET 1000 mg Once Daily|Eligible participants received single oral metformin (OXEMET) 1000 milligrams (mg) for one day in each of the two treatment periods in a randomized manner. Participants had a washout period of 7 days between two treatment periods and were followed up to 7 days after the last dose of the study drug.
129261|NCT01842607|B1|Baseline|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
129262|NCT01842607|P1|Participant Flow|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
129263|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
129264|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
129265|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
129266|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
129267|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
129268|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
129269|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
129270|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
129271|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
129272|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
129273|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
129274|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
129275|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
129276|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
129277|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
129278|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
129279|NCT01842607|E1|Reported Event|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
129280|NCT01842594|B1|Baseline|Sirolimus and Hydroxychloroquine|Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks.
129281|NCT01842594|P1|Participant Flow|Sirolimus and Hydroxychloroquine|Patients received 1 mg of sirolimus (rapamycin, Rapa) and 200 mg of hydroxychloroquine (HCQ) twice a day before a meal for 2 weeks.
129282|NCT01842594|O1|Outcome|Sirolimus and Hydroxychloroquine|Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks.
129283|NCT01842594|O1|Outcome|Sirolimus and Hydroxychloroquine|Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks.
129284|NCT01842594|E1|Reported Event|Sirolimus and Hydroxychloroquine|Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks.
129285|NCT01842464|B1|Baseline|Anterior Sacro-Spinos Support|Anterior Sacro-Spinous Support :
129288|NCT01842464|O1|Outcome|Anterior Sacro-Spinos Support|Anterior Sacro-Spinous Support :
129289|NCT01842464|O1|Outcome|Anterior Sacro-Spinous Support|Number of participants with successful Sacro-Spinous Ligaments Anterior Apical Anchoring
129290|NCT01842464|E1|Reported Event|Anterior Sacro-Spinos Support|Anterior Sacro-Spinous Support :
129291|NCT01842438|B3|Baseline|Total|Total of all reporting groups
129292|NCT01842438|B2|Baseline|Control|This group will not receive the intervention during the life-span of the project
129293|NCT01842438|B1|Baseline|Behavioral: Psychosexual Intervention|"6-sessions of couple support focused on relationships and psychosexual functioning~Behavioral: psychosexual intervention"
129294|NCT01842438|P2|Participant Flow|Control|This group will not receive the intervention during the life-span of the project
129295|NCT01842438|P1|Participant Flow|Behavioral: Psychosexual Intervention|"6-sessions of couple support focused on relationships and psychosexual functioning~Behavioral: psychosexual intervention"
129296|NCT01842438|O2|Outcome|Control|This group will not receive the intervention during the life-span of the project
129297|NCT01842438|O1|Outcome|Behavioral: Psychosexual Intervention|"6-sessions of couple support focused on relationships and psychosexual functioning~Behavioral: psychosexual intervention"
129298|NCT01842438|O4|Outcome|Control: Partners|Did not receive the intervention; mostly females, but one male as there was one same-sex couple participating.
129299|NCT01842438|O3|Outcome|Control: Patient Group|Did not receive the intervention. All males
129300|NCT01842438|O2|Outcome|Intervention: Partners|This group received the intervention during the life-span of the project. Partners only.
129301|NCT01842438|O1|Outcome|Behavioral: Psychosexual Intervention PATIENTS|"6-sessions of couple support focused on relationships and psychosexual functioning~Behavioral: psychosexual intervention~This data is patients-only (all males)"
129302|NCT01842438|O2|Outcome|Control|This group will not receive the intervention during the life-span of the project
129303|NCT01842438|O1|Outcome|Behavioral: Psychosexual Intervention|"6-sessions of couple support focused on relationships and psychosexual functioning~Behavioral: psychosexual intervention"
129304|NCT01842438|E2|Reported Event|Control|This group will not receive the intervention during the life-span of the project
129305|NCT01842438|E1|Reported Event|Behavioral: Psychosexual Intervention|"6-sessions of couple support focused on relationships and psychosexual functioning~Behavioral: psychosexual intervention"
129306|NCT01841970|B1|Baseline|HET Arm|"Active arm. A single procedure with HET was used to treat Grade I and Grade II hemorrhoids~HET Bipolar System: The HET Bipolar System is used to treat hemorrhoids by bipolar ligation of the superior hemorrhoidal blood supply."
129307|NCT01841970|P1|Participant Flow|HET Arm|All subjects enrolled into the study were treated with the HET Bipolar System
129308|NCT01841970|O3|Outcome|Month 6|
129309|NCT01841970|O2|Outcome|Month 3|
129310|NCT01841970|O1|Outcome|Month 1|
129311|NCT01841970|O3|Outcome|Month 6|
129312|NCT01841970|O2|Outcome|Month 3|
129313|NCT01841970|O1|Outcome|Month 1|
129314|NCT01841970|O3|Outcome|Month 6|
129315|NCT01841970|O2|Outcome|Month 3|
129316|NCT01841970|O1|Outcome|Month 1|
129317|NCT01841970|O3|Outcome|Month 6|
129318|NCT01841970|O2|Outcome|Month 3|
129319|NCT01841970|O1|Outcome|Month 1|
129320|NCT01841970|O1|Outcome|HET Arm|
129321|NCT01841970|E1|Reported Event|HET Arm|
129322|NCT01841931|B1|Baseline|Patient|Enrolled patients
129323|NCT01841931|P1|Participant Flow|Patient|Enrolled patients
129324|NCT01841931|O1|Outcome|Patient|Enrolled patients
129325|NCT01841931|O1|Outcome|Patient|Enrolled patients
129326|NCT01841931|O1|Outcome|Patient|Enrolled patients
129327|NCT01841931|O1|Outcome|Patient|Enrolled patients
129328|NCT01841931|O1|Outcome|Patient|Enrolled patients
129329|NCT01841931|E1|Reported Event|Patient|Enrolled patients
129330|NCT01841697|B3|Baseline|Total|Total of all reporting groups
129331|NCT01841697|B2|Baseline|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
129332|NCT01841697|B1|Baseline|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
129333|NCT01841697|P2|Participant Flow|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
129334|NCT01841697|P1|Participant Flow|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
129335|NCT01841697|O2|Outcome|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
129336|NCT01841697|O1|Outcome|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
129380|NCT01841593|O3|Outcome|Amlodipine PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
129584|NCT01839604|P5|Participant Flow|AZD9150 3mg/kg|Pooled over parts A & B
129337|NCT01841697|O2|Outcome|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
129338|NCT01841697|O1|Outcome|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
129339|NCT01841697|O2|Outcome|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
129340|NCT01841697|O1|Outcome|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
129341|NCT01841697|O2|Outcome|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
129342|NCT01841697|O1|Outcome|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
129343|NCT01841697|O2|Outcome|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
129344|NCT01841697|O1|Outcome|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
129345|NCT01841697|O2|Outcome|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
129346|NCT01841697|O1|Outcome|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
129347|NCT01841697|E2|Reported Event|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
129348|NCT01841697|E1|Reported Event|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
129349|NCT01841619|B1|Baseline|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
129350|NCT01841619|P1|Participant Flow|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
129351|NCT01841619|O1|Outcome|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
129381|NCT01841593|O2|Outcome|Raltegravir PK (Administered With Amlodipine)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
129382|NCT01841593|O1|Outcome|Raltegravir PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
129383|NCT01841593|E2|Reported Event|Group B|DAYS 1 to 7: amlodipine 5 mg OD DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: raltegravir 400 mg BID
129352|NCT01841619|O1|Outcome|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
129353|NCT01841619|O1|Outcome|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
129354|NCT01841619|O1|Outcome|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
129355|NCT01841619|O1|Outcome|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
129356|NCT01841619|E1|Reported Event|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
129357|NCT01841606|B3|Baseline|Total|Total of all reporting groups
129358|NCT01841606|B2|Baseline|Placebo|10mL IV normal saline
129359|NCT01841606|B1|Baseline|Ondansetron|4mg IV Ondansetron
129360|NCT01841606|P2|Participant Flow|Placebo|Patients receiving placebo
129361|NCT01841606|P1|Participant Flow|Ondansetron|Patients receiving pre-spinal ondansetron
129362|NCT01841606|O2|Outcome|Placebo|Patients receiving placebo
129363|NCT01841606|O1|Outcome|Ondansetron|Patients receiving pre-spinal ondansetron
129364|NCT01841606|E2|Reported Event|Placebo|Patients receiving placebo
129365|NCT01841606|E1|Reported Event|Ondansetron|Patients receiving pre-spinal ondansetron
129366|NCT01841593|B3|Baseline|Total|Total of all reporting groups
129367|NCT01841593|B2|Baseline|Group B|DAYS 1 to 7: amlodipine 5 mg OD DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: raltegravir 400 mg BID
129368|NCT01841593|B1|Baseline|Group A|DAYS 1 to 7: raltegravir 400 mg BID DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: amlodipine 5 mg OD
129369|NCT01841593|P2|Participant Flow|Group B (Amlodipine Then Raltegravir)|DAYS 1 to 7: amlodipine 5 mg OD DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: raltegravir 400 mg BID
129370|NCT01841593|P1|Participant Flow|Group A (Raltegravir Then Amlodipine)|DAYS 1 to 7: raltegravir 400 mg BID DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: amlodipine 5 mg OD
129371|NCT01841593|O2|Outcome|Amlodipine PK (Administered With Raltegravir)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
129372|NCT01841593|O1|Outcome|Amlodipine PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
129373|NCT01841593|O2|Outcome|Raltegravir PK (Administered With Amlodipine)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
129374|NCT01841593|O1|Outcome|Raltegravir PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
129375|NCT01841593|O2|Outcome|Amlodipine PK (Administered With Raltegravir)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
129376|NCT01841593|O1|Outcome|Amlodipine PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
129377|NCT01841593|O2|Outcome|Raltegravir PK (Administered With Amlodipine)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
129378|NCT01841593|O1|Outcome|Raltegravir PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
129379|NCT01841593|O4|Outcome|Amlodipine PK (Administered With Raltegravir)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
129384|NCT01841593|E1|Reported Event|Group A|DAYS 1 to 7: raltegravir 400 mg BID DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: amlodipine 5 mg OD
129385|NCT01841567|B1|Baseline|Dressing|"Mepilex border post. op~Mepilex border post op"
129386|NCT01841567|P1|Participant Flow|Dressing|"Mepilex border post. op~Mepilex border post op"
129387|NCT01841567|O1|Outcome|Dressing|"Mepilex border post. op~Mepilex border post op"
129388|NCT01841567|O1|Outcome|Dressing|"Mepilex border post. op~Mepilex border post op"
129389|NCT01841567|E1|Reported Event|Dressing|"Mepilex border post. op~Mepilex border post op"
129390|NCT01841216|B3|Baseline|Total|Total of all reporting groups
129391|NCT01841216|B2|Baseline|Healthy|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
129392|NCT01841216|B1|Baseline|Low Back Pain|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
129393|NCT01841216|P2|Participant Flow|Healthy|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
129394|NCT01841216|P1|Participant Flow|Low Back Pain|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
129395|NCT01841216|O2|Outcome|Healthy|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
129396|NCT01841216|O1|Outcome|Low Back Pain|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
129397|NCT01841216|O2|Outcome|Healthy|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
129398|NCT01841216|O1|Outcome|Low Back Pain|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
129399|NCT01841216|E2|Reported Event|Healthy|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
129400|NCT01841216|E1|Reported Event|Low Back Pain|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
129401|NCT01841021|B1|Baseline|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
129402|NCT01841021|P1|Participant Flow|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
129403|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
129404|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
129405|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
129406|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
129407|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
129408|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
129409|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
129410|NCT01841021|E1|Reported Event|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
129411|NCT01840943|B3|Baseline|Total|Total of all reporting groups
129412|NCT01840943|B2|Baseline|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
129413|NCT01840943|B1|Baseline|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
129414|NCT01840943|P2|Participant Flow|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
129415|NCT01840943|P1|Participant Flow|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
129416|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
129417|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
129418|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
129419|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
129420|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
157749|NCT01717989|O5|Outcome|December 2011|
129421|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
129422|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
129423|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
129424|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
129425|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
129426|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
129427|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
129428|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
129429|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
129430|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
129431|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
129432|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
129433|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
129434|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
129435|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
129436|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
129437|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
129438|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
129439|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
129440|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
129441|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
129442|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
129443|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
129444|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
129445|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
129446|NCT01840943|E2|Reported Event|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
129447|NCT01840943|E1|Reported Event|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
129448|NCT01840605|B3|Baseline|Total|Total of all reporting groups
129449|NCT01840605|B2|Baseline|Ketotifen Fumarate|Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
129450|NCT01840605|B1|Baseline|TAU-284|TAU-284 10mg twice daily for 2 weeks
129451|NCT01840605|P2|Participant Flow|Ketotifen Fumarate|Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
129452|NCT01840605|P1|Participant Flow|TAU-284|TAU-284 10mg twice daily for 2 weeks
129453|NCT01840605|O2|Outcome|Ketotifen Fumarate|Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
129454|NCT01840605|O1|Outcome|TAU-284|TAU-284 10mg twice daily for 2 weeks
129455|NCT01840605|O2|Outcome|Ketotifen Fumarate|Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
129456|NCT01840605|O1|Outcome|TAU-284|TAU-284 10mg twice daily for 2 weeks
129457|NCT01840605|O2|Outcome|Ketotifen Fumarate|Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
129458|NCT01840605|O1|Outcome|TAU-284|TAU-284 10mg twice daily for 2 weeks
129459|NCT01840605|O2|Outcome|Ketotifen Fumarate|Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
129460|NCT01840605|O1|Outcome|TAU-284|TAU-284 10mg twice daily for 2 weeks
129461|NCT01840605|E2|Reported Event|Ketotifen Fumarate|Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
129462|NCT01840605|E1|Reported Event|TAU-284|TAU-284 10mg twice daily for 2 weeks
129463|NCT01840410|B3|Baseline|Total|Total of all reporting groups
129577|NCT01839695|E1|Reported Event|Valiant Mona LSA Stent Graft System|"TEVAR procedure using Medtronic Stent Graft >~> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device"
129464|NCT01840410|B2|Baseline|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
129465|NCT01840410|B1|Baseline|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
129466|NCT01840410|P2|Participant Flow|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
129467|NCT01840410|P1|Participant Flow|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
129468|NCT01840410|O3|Outcome|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
129469|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
129470|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
129471|NCT01840410|O3|Outcome|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
129472|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
129473|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
129474|NCT01840410|O3|Outcome|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
129475|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
129476|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
129477|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
129478|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
129479|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
129480|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
129481|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
129482|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
129483|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
129484|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
129485|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
129486|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
129487|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
129488|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
129489|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
129490|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
129491|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
129492|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
129578|NCT01839604|B6|Baseline|Total|Total of all reporting groups
129579|NCT01839604|B5|Baseline|3 mg/kg|given intravenously (Part A & B pooled)
129580|NCT01839604|B4|Baseline|2.5 mg/kg|given intravenously Part A
129493|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
129494|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
129495|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
129496|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
129497|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
129498|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
129499|NCT01840410|E3|Reported Event|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
129500|NCT01840410|E2|Reported Event|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At month 1, if treatment was needed, sham was administered. At month 2, participants switched to open-label ranibizumab on an as needed basis.
129501|NCT01840410|E1|Reported Event|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
129502|NCT01840345|B1|Baseline|N-acetyl-L-cysteine|"n-acetyl-l-cysteine 1200 mg BID x 4 weeks~N-acetyl-l-cysteine: 1200 mg BID x 4 weeks"
129503|NCT01840345|P1|Participant Flow|N-acetyl-L-cysteine|"n-acetyl-l-cysteine 1200 mg BID x 4 weeks~N-acetyl-l-cysteine: 1200 mg BID x 4 weeks"
129504|NCT01840345|O1|Outcome|N-acetyl-L-cysteine|"n-acetyl-l-cysteine 1200 mg BID x 4 weeks~N-acetyl-l-cysteine: 1200 mg BID x 4 weeks"
129505|NCT01840345|O1|Outcome|N-acetyl-L-cysteine|"n-acetyl-l-cysteine 1200 mg BID x 4 weeks~N-acetyl-l-cysteine: 1200 mg BID x 4 weeks"
129506|NCT01840345|O1|Outcome|N-acetyl-L-cysteine|"n-acetyl-l-cysteine 1200 mg BID x 4 weeks~N-acetyl-l-cysteine: 1200 mg BID x 4 weeks"
129507|NCT01840345|O1|Outcome|N-acetyl-L-cysteine|"n-acetyl-l-cysteine 1200 mg BID x 4 weeks~N-acetyl-l-cysteine: 1200 mg BID x 4 weeks"
129508|NCT01840345|E1|Reported Event|N-acetyl-L-cysteine|"n-acetyl-l-cysteine 1200 mg BID x 4 weeks~N-acetyl-l-cysteine: 1200 mg BID x 4 weeks"
129509|NCT01840319|B1|Baseline|Tigecycline|Participants who had received tigecycline, alone or in combination in the initial study, for the treatment of a bacterial infection, were retrospectively observed for survival up to 30 days after last dose of tigecycline.
129510|NCT01840319|P1|Participant Flow|Tigecycline|Participants who had received tigecycline, alone or in combination in the initial study, for the treatment of a bacterial infection, were retrospectively observed for survival up to 30 days after last dose of tigecycline.
129511|NCT01840319|O1|Outcome|Tigecycline|Participants who had received tigecycline, alone or in combination in the initial study, for the treatment of a bacterial infection, were retrospectively observed for survival up to 30 days after last dose of tigecycline.
129512|NCT01840319|E1|Reported Event|Tigecycline|Participants who had received tigecycline, alone or in combination in the initial study, for the treatment of a bacterial infection, were retrospectively observed for survival up to 30 days after last dose of tigecycline.
129513|NCT01840072|B3|Baseline|Total|Total of all reporting groups
129514|NCT01840072|B2|Baseline|Usual Care|Discontinue all home BP medications.
129515|NCT01840072|B1|Baseline|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
129516|NCT01840072|P2|Participant Flow|Usual Care|Discontinue all home BP medications.
129517|NCT01840072|P1|Participant Flow|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
129518|NCT01840072|O2|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
129519|NCT01840072|O1|Outcome|Usual Care|Discontinue all home BP medications.
129555|NCT01839708|O2|Outcome|No Lifestyle Counseling|"Comparison group: usual WIC care; read printed materials at home~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129520|NCT01840072|O2|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
129521|NCT01840072|O1|Outcome|Usual Care|Discontinue all home BP medications.
129522|NCT01840072|O2|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
129523|NCT01840072|O1|Outcome|Usual Care|Discontinue all home BP medications.
129524|NCT01840072|O2|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
129525|NCT01840072|O1|Outcome|Usual Care|Discontinue all home BP medications.
129526|NCT01840072|O2|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
129527|NCT01840072|O1|Outcome|Usual Care|Discontinue all home BP medications.
129528|NCT01840072|O2|Outcome|Usual Care|Discontinue all home BP medications.
129529|NCT01840072|O1|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
129530|NCT01840072|O2|Outcome|Usual Care|Discontinue all home BP medications.
129531|NCT01840072|O1|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
129532|NCT01840072|O2|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
129533|NCT01840072|O1|Outcome|Usual Care|Discontinue all home BP medications.
129534|NCT01840072|O2|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
129535|NCT01840072|O1|Outcome|Usual Care|Discontinue all home BP medications.
129536|NCT01840072|E2|Reported Event|Usual Care|Discontinue all home BP medications.
129556|NCT01839708|O1|Outcome|Lifestyle Counseling|"Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129537|NCT01840072|E1|Reported Event|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
129538|NCT01839708|B3|Baseline|Total|Total of all reporting groups
129539|NCT01839708|B2|Baseline|No Lifestyle Counseling|"Comparison group: usual WIC care; read printed materials at home~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129540|NCT01839708|B1|Baseline|Lifestyle Counseling|"Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129541|NCT01839708|P2|Participant Flow|No Lifestyle Counseling|"Comparison group: usual WIC care; read printed materials at home~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129542|NCT01839708|P1|Participant Flow|Lifestyle Counseling|"Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129543|NCT01839708|O2|Outcome|No Lifestyle Counseling|"Comparison group: usual WIC care; read printed materials at home~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129544|NCT01839708|O1|Outcome|Lifestyle Counseling|"Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129545|NCT01839708|O2|Outcome|No Lifestyle Counseling|"Comparison group: usual WIC care; read printed materials at home~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129546|NCT01839708|O1|Outcome|Lifestyle Counseling|"Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129547|NCT01839708|O2|Outcome|No Lifestyle Counseling|"Comparison group: usual WIC care; read printed materials at home~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129548|NCT01839708|O1|Outcome|Lifestyle Counseling|"Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129549|NCT01839708|O2|Outcome|No Lifestyle Counseling|"Comparison group: usual WIC care; read printed materials at home~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129550|NCT01839708|O1|Outcome|Lifestyle Counseling|"Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129551|NCT01839708|O2|Outcome|No Lifestyle Counseling|"Comparison group: usual WIC care; read printed materials at home~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129552|NCT01839708|O1|Outcome|Lifestyle Counseling|"Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129553|NCT01839708|O2|Outcome|No Lifestyle Counseling|"Comparison group: usual WIC care; read printed materials at home~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129554|NCT01839708|O1|Outcome|Lifestyle Counseling|"Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129581|NCT01839604|B3|Baseline|2 mg/kg|given intravenously Part A
129582|NCT01839604|B2|Baseline|1.5 mg/kg|given intravenously. Part A
129557|NCT01839708|O2|Outcome|No Lifestyle Counseling|"Comparison group: usual WIC care; read printed materials at home~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129558|NCT01839708|O1|Outcome|Lifestyle Counseling|"Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129559|NCT01839708|O2|Outcome|No Lifestyle Counseling|"Comparison group: usual WIC care; read printed materials at home~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129560|NCT01839708|O1|Outcome|Lifestyle Counseling|"Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129561|NCT01839708|O2|Outcome|No Lifestyle Counseling|"Comparison group: usual WIC care; read printed materials at home~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129562|NCT01839708|O1|Outcome|Lifestyle Counseling|"Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129563|NCT01839708|O2|Outcome|No Lifestyle Counseling|"Comparison group: usual WIC care; read printed materials at home~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129564|NCT01839708|O1|Outcome|Lifestyle Counseling|"Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129565|NCT01839708|O2|Outcome|No Lifestyle Counseling|"Comparison group: usual WIC care; read printed materials at home~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129566|NCT01839708|O1|Outcome|Lifestyle Counseling|"Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129567|NCT01839708|O2|Outcome|No Lifestyle Counseling|"Comparison group: usual WIC care; read printed materials at home~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129568|NCT01839708|O1|Outcome|Lifestyle Counseling|"Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129569|NCT01839708|O2|Outcome|No Lifestyle Counseling|"Comparison group: usual WIC care; read printed materials at home~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129570|NCT01839708|O1|Outcome|Lifestyle Counseling|"Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129571|NCT01839708|E2|Reported Event|No Lifestyle Counseling|"Comparison group: usual WIC care; read printed materials at home~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129572|NCT01839708|E1|Reported Event|Lifestyle Counseling|"Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.~Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention."
129573|NCT01839695|B1|Baseline|Valiant Mona LSA Stent Graft System|"TEVAR procedure using Medtronic Stent Graft >~> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device"
129574|NCT01839695|P1|Participant Flow|Valiant Mona LSA Stent Graft System|"TEVAR procedure using Medtronic Stent Graft >~> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device"
129575|NCT01839695|O1|Outcome|Valiant Mona LSA Stent Graft System|"TEVAR procedure using Medtronic Stent Graft >~> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device"
129576|NCT01839695|O1|Outcome|Valiant Mona LSA Stent Graft System|"TEVAR procedure using Medtronic Stent Graft >~> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device"
129583|NCT01839604|B1|Baseline|AZD9150 1mg/kg|Intravenous. Part A.
157750|NCT01717989|O4|Outcome|September 2011|
129585|NCT01839604|P4|Participant Flow|AZD9150 2.5mg/kg|Intravenous dosing Part A
129586|NCT01839604|P3|Participant Flow|AZD9150 2mg/kg|Intravenous dosing Part A
129587|NCT01839604|P2|Participant Flow|AZD9150 1.5 mg/kg|Intravenous dosing Part A
129588|NCT01839604|P1|Participant Flow|AZD9150 1mg/kg|Intravenous. Part A.
129589|NCT01839604|O5|Outcome|3 mg/kg|given intravenously (Part A & B pooled)
129590|NCT01839604|O4|Outcome|2.5 mg/kg|given intravenously Part A
129591|NCT01839604|O3|Outcome|2 mg/kg|given intravenously Part A
129592|NCT01839604|O2|Outcome|1.5 mg/kg|given intravenously. Part A
129593|NCT01839604|O1|Outcome|AZD9150 1mg/kg|Intravenous. Part A.
129594|NCT01839604|O5|Outcome|3 mg/kg|given intravenously (Part A & B pooled)
129595|NCT01839604|O4|Outcome|2.5 mg/kg|given intravenously Part A
129596|NCT01839604|O3|Outcome|2 mg/kg|given intravenously Part A
129597|NCT01839604|O2|Outcome|1.5 mg/kg|given intravenously. Part A
129598|NCT01839604|O1|Outcome|AZD9150 1mg/kg|Intravenous. Part A.
129599|NCT01839604|O5|Outcome|3 mg/kg|given intravenously (Part A & B pooled)
129600|NCT01839604|O4|Outcome|2.5 mg/kg|given intravenously Part A
129601|NCT01839604|O3|Outcome|2 mg/kg|given intravenously Part A
129602|NCT01839604|O2|Outcome|1.5 mg/kg|given intravenously. Part A
129603|NCT01839604|O1|Outcome|AZD9150 1mg/kg|Intravenous. Part A.
129604|NCT01839604|O5|Outcome|3 mg/kg|given intravenously (Part A & B pooled)
129605|NCT01839604|O4|Outcome|2.5 mg/kg|given intravenously Part A
129606|NCT01839604|O3|Outcome|2 mg/kg|given intravenously Part A
129607|NCT01839604|O2|Outcome|1.5 mg/kg|given intravenously. Part A
129608|NCT01839604|O1|Outcome|AZD9150 1mg/kg|Intravenous. Part A.
129609|NCT01839604|E5|Reported Event|3 mg/kg|given intravenously (Part A & B pooled)
129610|NCT01839604|E4|Reported Event|2.5 mg/kg|given intravenously Part A
129611|NCT01839604|E3|Reported Event|2 mg/kg|given intravenously Part A
129612|NCT01839604|E2|Reported Event|1.5 mg/kg|given intravenously. Part A
129613|NCT01839604|E1|Reported Event|AZD9150 1mg/kg|Intravenous. Part A.
129614|NCT01839318|B1|Baseline|Overall|Nelfilcon A contact lenses, etafilcon A contact lenses, and omafilcon A contact lenses worn in a cross-over assignment.
129615|NCT01839318|P6|Participant Flow|Sequence 6|Etafilcon A contact lenses worn first, followed by nelfilcon A contact lenses worn second, then omafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
129616|NCT01839318|P5|Participant Flow|Sequence 5|Etafilcon A contact lenses worn first, followed by omafilcon A contact lenses worn second, then nelfilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
129617|NCT01839318|P4|Participant Flow|Sequence 4|Nelfilcon A contact lenses worn first, followed by omafilcon A contact lenses worn second, then etafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
129618|NCT01839318|P3|Participant Flow|Sequence 3|Nelfilcon A contact lenses worn first, followed by etafilcon A contact lenses worn second, then omafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
129619|NCT01839318|P2|Participant Flow|Sequence 2|Omafilcon A contact lenses worn first, followed by etafilcon A contact lenses worn second, then nelfilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
129620|NCT01839318|P1|Participant Flow|Sequence 1|Omafilcon A contact lenses worn first, followed by nelfilcon A contact lenses worn second, then etafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
129621|NCT01839318|O3|Outcome|Proclear 1 Day|Omafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
129622|NCT01839318|O2|Outcome|1-DAY ACUVUE MOIST|Etafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
129623|NCT01839318|O1|Outcome|DAILIES AquaComfort Plus|Nelfilcon A contact lenses worn in a randomized order for 1 day, 12 hours
129624|NCT01839318|O3|Outcome|Proclear 1 Day|Omafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
129625|NCT01839318|O2|Outcome|1-DAY ACUVUE MOIST|Etafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
129626|NCT01839318|O1|Outcome|DAILIES AquaComfort Plus|Nelfilcon A contact lenses worn in a randomized order for 1 day, 12 hours
129627|NCT01839318|E3|Reported Event|Proclear 1 Day|Omafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
129628|NCT01839318|E2|Reported Event|1-DAY ACUVUE MOIST|Etafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
129629|NCT01839318|E1|Reported Event|DAILIES AquaComfort Plus|Nelfilcon A contact lenses worn in a randomized order for 1 day, 12 hours
129630|NCT01839279|B4|Baseline|Total|Total of all reporting groups
129631|NCT01839279|B3|Baseline|Initial Moxifloxacin and Crossover to Placebo|Dosing of moxifloxacin will only be analyzed for cause (if the effect of moxifloxacin is not as expected).
129632|NCT01839279|B2|Baseline|Initial Placebo and Crossover to Moxifloxacin|Dosing of moxifloxacin will only be analyzed for cause (if the effect of moxifloxacin is not as expected).
129633|NCT01839279|B1|Baseline|Tizanidine|
129634|NCT01839279|P3|Participant Flow|Initial Moxifloxacin and Crossover to Placebo|Dosing of moxifloxacin will only be analyzed for cause (if the effect of moxifloxacin is not as expected).
129635|NCT01839279|P2|Participant Flow|Initial Placebo and Crossover to Moxifloxacin|Dosing of moxifloxacin will only be analyzed for cause (if the effect of moxifloxacin is not as expected).
129636|NCT01839279|P1|Participant Flow|Tizanidine|
129637|NCT01839279|O2|Outcome|Day 14 (Tizanidine 24 mg)|
129638|NCT01839279|O1|Outcome|Day 5 (Tizanidine 8 mg)|
129639|NCT01839279|O2|Outcome|Day 14 (Tizanidine 24 mg)|
129640|NCT01839279|O1|Outcome|Day 5 (Tizanidine 8 mg)|
129641|NCT01839279|O2|Outcome|Day 14 (Tizanidine 24 mg)|
129642|NCT01839279|O1|Outcome|Day 5 (Tizanidine 8 mg)|
129643|NCT01839279|O1|Outcome|Tizanidine|
129644|NCT01839279|O3|Outcome|Tizanidine 8 mg Placebo-corrected|70 subjects Tizanidine 8 mg single dose, 63 subjects placebo used for analysis.
129645|NCT01839279|O2|Outcome|Tizanidine Placebo 8 mg|63 subjects placebo used for analysis.
129646|NCT01839279|O1|Outcome|Tizanidine 8 mg|70 subjects Tizanidine 8 mg single dose.
157751|NCT01717989|O3|Outcome|June 2011|
129647|NCT01839279|O3|Outcome|Tizanidine 24 mg Placebo-corrected|60 subjects Tizanidine 24 mg single dose, 61 subjects placebo used for the analysis.
129648|NCT01839279|O2|Outcome|Tizanidine Placebo 24 mg|61 subjects placebo used for the analysis.
129649|NCT01839279|O1|Outcome|Tizanidine 24 mg|60 subjects Tizanidine 24 mg single dose
129650|NCT01839279|E4|Reported Event|Placebo and Moxifloxacin Groups Combined|
129651|NCT01839279|E3|Reported Event|Initial Moxifloxacin and Crossover to Placebo|
129652|NCT01839279|E2|Reported Event|Initial Placebo and Crossover to Moxifloxacin|
129653|NCT01839279|E1|Reported Event|Tizanidine|
129654|NCT01839058|B3|Baseline|Total|Total of all reporting groups
129655|NCT01839058|B2|Baseline|Healthy Controls|"Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing.~Esophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus."
129656|NCT01839058|B1|Baseline|Non Cardiac Chest Pain Patients|"Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing.~Esophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus."
129657|NCT01839058|P2|Participant Flow|Healthy Controls|"Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing.~Esophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus."
129658|NCT01839058|P1|Participant Flow|Non Cardiac Chest Pain Patients|"Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing.~Esophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus."
129659|NCT01839058|O2|Outcome|Healthy Controls|"Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing.~Esophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus."
129660|NCT01839058|O1|Outcome|Non Cardiac Chest Pain Patients|"Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing.~Esophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus."
129661|NCT01839058|E2|Reported Event|Healthy Controls|"Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing.~Esophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus."
129662|NCT01839058|E1|Reported Event|Non Cardiac Chest Pain Patients|"Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing.~Esophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus."
129663|NCT01838980|B1|Baseline|Colonoscopy|Motus GI Clean-Up Device
129664|NCT01838980|P1|Participant Flow|Colonoscopy|Motus GI Clean-Up Device
129665|NCT01838980|O1|Outcome|Colonoscopy|Motus GI Clean-Up Device
129666|NCT01838980|E1|Reported Event|Colonoscopy|Motus GI Clean-Up Device
129667|NCT01838941|B1|Baseline|Betaine|"Betaine will be given orally to all participants and dose will be adjusted to body weight.~Betaine: Betaine given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube:~6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)~12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time)."
129668|NCT01838941|P1|Participant Flow|Betaine|"Betaine will be given orally to all participants and dose will be adjusted to body weight.~Betaine: Betaine will be given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube as follows:~6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)~12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time)."
129669|NCT01838941|O1|Outcome|Betaine|"Betaine will be given orally to all participants and dose will be adjusted to body weight.~Betaine: Betaine will be given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube as follows:~6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)~12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time)."
129670|NCT01838941|O1|Outcome|Betaine|"Betaine will be given orally to all participants and dose will be adjusted to body weight.~Betaine will be given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube as follows:~6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)~12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time)."
129671|NCT01838941|E1|Reported Event|Betaine|"Betaine will be given orally to all participants and dose will be adjusted to body weight.~Betaine: Betaine will be given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube as follows:~6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)~12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time)."
129672|NCT01838785|B1|Baseline|18F-DTBZ AV-133|"18F-DTBZ AV-133 imaging~18F-DTBZ AV-133"
129673|NCT01838785|P1|Participant Flow|18F-DTBZ AV-133|"18F-DTBZ AV-133 imaging~18F-DTBZ AV-133"
129674|NCT01838785|O1|Outcome|18F-DTBZ AV-133|"18F-DTBZ AV-133 imaging~18F-DTBZ AV-133"
129675|NCT01838785|O1|Outcome|18F-DTBZ AV-133|"18F-DTBZ AV-133 imaging~18F-DTBZ AV-133"
129676|NCT01838785|E1|Reported Event|18F-DTBZ AV-133|"18F-DTBZ AV-133 imaging~18F-DTBZ AV-133"
129677|NCT01838694|B3|Baseline|Total|Total of all reporting groups
129678|NCT01838694|B2|Baseline|Ala-Cpn10|"Recombinant minimally modified Chaperonin10 (Cpn10) Multiple doses in the range of 10mg twice weekly to 100mg twice weekly administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
129679|NCT01838694|B1|Baseline|Placebo|"Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.~Placebo"
129680|NCT01838694|P2|Participant Flow|Ala-Cpn10|"Recombinant minimally modified Chaperonin10 (Cpn10) Multiple doses in the range of 10mg twice weekly to 100mg twice weekly administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
129681|NCT01838694|P1|Participant Flow|Placebo|"Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.~Placebo"
129682|NCT01838694|O5|Outcome|Ala-Cpn10 - 30mgs in Moderate SLE|"Recombinant minimally modified Chaperonin10 (Cpn10) 30mg twice weekly administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
129683|NCT01838694|O4|Outcome|Ala-Cpn10 - 100mgs in Mild SLE|"Recombinant minimally modified Chaperonin10 (Cpn10) 100mg twice weekly administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
129684|NCT01838694|O3|Outcome|Ala-Cpn10 - 30mgs in Mild SLE|"Recombinant minimally modified Chaperonin10 (Cpn10) 30mg twice weekly administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
129685|NCT01838694|O2|Outcome|Ala-Cpn10 - 10mgs in Mild SLE|"Recombinant minimally modified Chaperonin10 (Cpn10) 10mg twice weekly administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
129686|NCT01838694|O1|Outcome|Placebo|"Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.~Placebo"
129687|NCT01838694|E2|Reported Event|Ala-Cpn10|"Recombinant minimally modified Chaperonin10 (Cpn10) Multiple doses in the range (0.16mg/kg [10mg twice weekly] to 5mg/kg [300mg twice weekly]) administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
129688|NCT01838694|E1|Reported Event|Placebo|"Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.~Placebo"
129689|NCT01838681|B1|Baseline|All Enrolled Patients|Period A
129690|NCT01838681|P4|Participant Flow|Period A+ Placebo and ADT (Non-randomised Patients)|"Placebo adjunct to open-label treatment with ADT (same ADT as in Period A)~Placebo: Once daily, tablets, orally"
129691|NCT01838681|P3|Participant Flow|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with ADT (same ADT as in Period A)~Brexpiprazole: flexible dose; 1, 2, or 3 mg/day, once daily, tablets, orally"
129692|NCT01838681|P2|Participant Flow|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with ADT (same ADT as in Period A)~Placebo: Once daily, tablets, orally"
129693|NCT01838681|P1|Participant Flow|Period A Placebo and ADT (8 Weeks)|"Placebo adjunct to open-label treatment with ADT~Placebo: Once daily, tablets, orally"
129694|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
129695|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT~Placebo: Once daily, tablets, orally"
129696|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
129697|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT~Placebo: Once daily, tablets, orally"
129698|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
129699|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT~Placebo: Once daily, tablets, orally"
129700|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
129701|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT~Placebo: Once daily, tablets, orally"
129702|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
129703|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT~Placebo: Once daily, tablets, orally"
129704|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
129705|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT~Placebo: Once daily, tablets, orally"
129706|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
129707|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT~Placebo: Once daily, tablets, orally"
129708|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
129709|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT~Placebo: Once daily, tablets, orally"
129710|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
129711|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT~Placebo: Once daily, tablets, orally"
129712|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
129713|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT~Placebo: Once daily, tablets, orally"
129714|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
129715|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT~Placebo: Once daily, tablets, orally"
129716|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
129717|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT~Placebo: Once daily, tablets, orally"
129718|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
129719|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT~Placebo: Once daily, tablets, orally"
129720|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
129721|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT~Placebo: Once daily, tablets, orally"
129722|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
129723|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT~Placebo: Once daily, tablets, orally"
129724|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
129725|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT~Placebo: Once daily, tablets, orally"
129726|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
129727|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT~Placebo: Once daily, tablets, orally"
129728|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
129729|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT~Placebo: Once daily, tablets, orally"
129730|NCT01838681|E2|Reported Event|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1, 2, 3, mg/day, once daily, tablets, orally"
129731|NCT01838681|E1|Reported Event|Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
129732|NCT01838655|B1|Baseline|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129733|NCT01838655|P1|Participant Flow|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129734|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129735|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129736|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129737|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129738|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129739|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129740|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129741|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129742|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129743|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129744|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129745|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129746|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129747|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129748|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129749|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
130318|NCT01836458|E4|Reported Event|Dose 4: 15mg|Single dose of KAE609 15 mg
129750|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129751|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129752|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129753|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129754|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129755|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129756|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129757|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129758|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129759|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129760|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129761|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129762|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129763|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129764|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129765|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129766|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129767|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129768|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129769|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129770|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129771|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129772|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129773|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129774|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129775|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129776|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129777|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129778|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129779|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129780|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129781|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129782|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129783|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129784|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129785|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129786|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129787|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129788|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129789|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129790|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129791|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129792|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129793|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129794|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129795|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129796|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129797|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129798|NCT01838655|O1|Outcome|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129799|NCT01838655|E1|Reported Event|Nitisinone|"Oral administration of nitisinone~Nitisinone: Oral dose of 2mg daily for 12 months."
129902|NCT01838590|O4|Outcome|SOF+RBV 24 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
130319|NCT01836458|E3|Reported Event|Dose 3: 10mg|Single dose of KAE609 10 mg
129800|NCT01838642|B1|Baseline|RET Mutation Positive Participants|"Rearranged during transfection (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
129801|NCT01838642|P1|Participant Flow|RET Mutation Positive Participants.|"Rearranged during transfection (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
129802|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
129803|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
129804|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
129805|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
129806|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
129807|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
129808|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
129809|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
129810|NCT01838642|E1|Reported Event|RET Mutation Positive Participants|"Rearranged during transfection) (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
129811|NCT01838616|B3|Baseline|Total|Total of all reporting groups
129812|NCT01838616|B2|Baseline|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129813|NCT01838616|B1|Baseline|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129814|NCT01838616|P2|Participant Flow|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129815|NCT01838616|P1|Participant Flow|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129816|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129817|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
157752|NCT01717989|O2|Outcome|March 2011|
129818|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129819|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129820|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129821|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129822|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129823|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129824|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129825|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129826|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129827|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129828|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129829|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129830|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129831|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129903|NCT01838590|O3|Outcome|SOF+RBV 24 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
130320|NCT01836458|E2|Reported Event|Dose 2: 20mg|Single dose of KAE609 20 mg
129832|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129833|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129834|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129835|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129836|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129837|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129838|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129839|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129840|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129841|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129842|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129843|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129844|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129845|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129904|NCT01838590|O2|Outcome|SOF+RBV 12 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
130321|NCT01836458|E1|Reported Event|Dose 1: 30mg|Single dose of KAE609 30 mg
129846|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129847|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129848|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129849|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129850|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129851|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129852|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129853|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129854|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129855|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129856|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129857|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129858|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129859|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129905|NCT01838590|O1|Outcome|SOF+RBV 12 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
130550|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
129860|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129861|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129862|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129863|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129864|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129865|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129866|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129867|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129868|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129869|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129870|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129871|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129872|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129873|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129906|NCT01838590|E2|Reported Event|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
130554|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
129874|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129875|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129876|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily a day (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129877|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks
129878|NCT01838616|E3|Reported Event|Tapentadol (PR) After Oxycodone/Naloxone (PR) Treatment|Participants in the oxycodone/naloxone PR treatment arm that did not reach the minimum target of titration or experiencing intolerable side effects at the end of the Titration Period could be switched to the Pick-up Arm. They could also enter the Pick-up Arm at any time during the Titration Period or Continuation Period, via an unscheduled visit, due to lack of tolerability or lack of efficacy under treatment with oxycodone/naloxone PR. Participants were directly switched from oxycodone/naloxone PR to tapentadol PR using an equianalgesic ratio of 1:5 (oxycodone : tapentadol), together with a down-titration step under tapentadol PR (except for participants on oxycodone/naloxone PR 10 mg/5 mg twice daily).
129879|NCT01838616|E2|Reported Event|Oxycodone/Naloxone Prolonged Release (PR)|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily a day (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129880|NCT01838616|E1|Reported Event|Tapentadol Prolonged Release (PR)|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
129881|NCT01838590|B5|Baseline|Total|Total of all reporting groups
129882|NCT01838590|B4|Baseline|SOF+RBV 24 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
129883|NCT01838590|B3|Baseline|SOF+RBV 24 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
129884|NCT01838590|B2|Baseline|SOF+RBV 12 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced (TE))
129885|NCT01838590|B1|Baseline|SOF+RBV 12 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive (TN))
129886|NCT01838590|P2|Participant Flow|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
129887|NCT01838590|P1|Participant Flow|SOF+RBV 12 Weeks|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks
129888|NCT01838590|O4|Outcome|SOF+RBV 24 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
129889|NCT01838590|O3|Outcome|SOF+RBV 24 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
129890|NCT01838590|O2|Outcome|SOF+RBV 12 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
129891|NCT01838590|O1|Outcome|SOF+RBV 12 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
129892|NCT01838590|O4|Outcome|SOF+RBV 24 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
129893|NCT01838590|O3|Outcome|SOF+RBV 24 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
129894|NCT01838590|O2|Outcome|SOF+RBV 12 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
129895|NCT01838590|O1|Outcome|SOF+RBV 12 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
129896|NCT01838590|O4|Outcome|SOF+RBV 24 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
129897|NCT01838590|O3|Outcome|SOF+RBV 24 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
129898|NCT01838590|O2|Outcome|SOF+RBV 12 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
129899|NCT01838590|O1|Outcome|SOF+RBV 12 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
129900|NCT01838590|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
129901|NCT01838590|O1|Outcome|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
129907|NCT01838590|E1|Reported Event|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
129908|NCT01838499|B3|Baseline|Total|Total of all reporting groups
129909|NCT01838499|B2|Baseline|Saline|SC injection
129910|NCT01838499|B1|Baseline|MEDI8968|SC injection
129911|NCT01838499|P2|Participant Flow|Saline|SC injection
129912|NCT01838499|P1|Participant Flow|MEDI8968|SC injection
129913|NCT01838499|O2|Outcome|Saline|SC injection
129914|NCT01838499|O1|Outcome|MEDI8968|SC injection
129915|NCT01838499|O2|Outcome|Saline|SC injection
129916|NCT01838499|O1|Outcome|MEDI8968|SC injection
129917|NCT01838499|O2|Outcome|Saline|SC injection
129918|NCT01838499|O1|Outcome|MEDI8968|SC injection
129919|NCT01838499|E2|Reported Event|Saline|SC injection
129920|NCT01838499|E1|Reported Event|MEDI8968|SC injection
129921|NCT01838304|B3|Baseline|Total|Total of all reporting groups
129922|NCT01838304|B2|Baseline|Probability Ramp Control|"Propofol titrated to deep sedation using PRC software.~Probability ramp control: Decision support software that calculates propofol doses appropriate for age and weight of the patient"
129923|NCT01838304|B1|Baseline|Monitoring|"Standard of care sedation by CRNA using proposal with manual recording of drug dosing~Monitoring: Manual recording of drug doses determined by CRNA"
129924|NCT01838304|P2|Participant Flow|Probability Ramp Control|"Propofol titrated to deep sedation using PRC software.~Probability ramp control: Decision support software that calculates propofol doses appropriate for age and weight of the patient"
129925|NCT01838304|P1|Participant Flow|Monitoring|"Standard of care sedation by CRNA using proposal with manual recording of drug dosing~Monitoring: Manual recording of drug doses determined by CRNA"
129926|NCT01838304|O2|Outcome|Probability Ramp Control|"Propofol titrated to deep sedation using PRC software.~Probability ramp control: Decision support software that calculates propofol doses appropriate for age and weight of the patient"
129927|NCT01838304|O1|Outcome|Monitoring|"Standard of care sedation by CRNA using proposal with manual recording of drug dosing~Monitoring: Manual recording of drug doses determined by CRNA"
129928|NCT01838304|O2|Outcome|Probability Ramp Control|"Propofol titrated to deep sedation using PRC software.~Probability ramp control: Decision support software that calculates propofol doses appropriate for age and weight of the patient"
129929|NCT01838304|O1|Outcome|Monitoring|"Standard of care sedation by CRNA using proposal with manual recording of drug dosing~Monitoring: Manual recording of drug doses determined by CRNA"
129930|NCT01838304|O2|Outcome|Probability Ramp Control|"Propofol titrated to deep sedation using PRC software.~Probability ramp control: Decision support software that calculates propofol doses appropriate for age and weight of the patient"
129931|NCT01838304|O1|Outcome|Monitoring|"Standard of care sedation by CRNA using proposal with manual recording of drug dosing~Monitoring: Manual recording of drug doses determined by CRNA"
129932|NCT01838304|O2|Outcome|Probability Ramp Control|"Propofol titrated to deep sedation using PRC software.~Probability ramp control: Decision support software that calculates propofol doses appropriate for age and weight of the patient"
129933|NCT01838304|O1|Outcome|Monitoring|"Standard of care sedation by CRNA using proposal with manual recording of drug dosing~Monitoring: Manual recording of drug doses determined by CRNA"
129934|NCT01838304|E2|Reported Event|Probability Ramp Control|"Propofol titrated to deep sedation using PRC software.~Probability ramp control: Decision support software that calculates propofol doses appropriate for age and weight of the patient"
129935|NCT01838304|E1|Reported Event|Monitoring|"Standard of care sedation by CRNA using proposal with manual recording of drug dosing~Monitoring: Manual recording of drug doses determined by CRNA"
129936|NCT01838213|B3|Baseline|Total|Total of all reporting groups
129937|NCT01838213|B2|Baseline|Patients With UTI Caused by Non-ESBL-producing E. Coli|Patients with UTI caused by non-ESBL-producing E. coli
129938|NCT01838213|B1|Baseline|Patients With UTI Caused by Extended-spectrum β-lactamase-prod|Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli
129939|NCT01838213|P2|Participant Flow|Patients With UTI Caused by Non-ESBL-producing E. Coli|Patients with UTI caused by non-ESBL-producing E. coli
129940|NCT01838213|P1|Participant Flow|Patients With UTI Caused by Extended-spectrum β-lactamase-prod|Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli
129941|NCT01838213|O2|Outcome|Patients With UTI Caused by Non-ESBL-producing E. Coli|Patients with UTI caused by non-ESBL-producing E. coli
129942|NCT01838213|O1|Outcome|Patients With UTI Caused by Extended-spectrum β-lactamase-prod|Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli
129943|NCT01838213|E2|Reported Event|Patients With UTI Caused by Non-ESBL-producing E. Coli|Patients with UTI caused by non-ESBL-producing E. coli
129944|NCT01838213|E1|Reported Event|Patients With UTI Caused by Extended-spectrum β-lactamase-prod|Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli
129945|NCT01838044|B3|Baseline|Total|Total of all reporting groups
129946|NCT01838044|B2|Baseline|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
130010|NCT01837823|O1|Outcome|Baseline|Prior to rosuvastatin therapy
130011|NCT01837823|O2|Outcome|8-12 Weeks|After 8-12 weeks of rosuvastatin
130012|NCT01837823|O1|Outcome|Baseline|Prior to rosuvastatin therapy
130013|NCT01837823|O1|Outcome|Rosuvastatin|All subjects will receive rosuvastatin 40mg/day 8-12 weeks
130014|NCT01837823|O1|Outcome|Rosuvastatin|All subjects will receive rosuvastatin 40mg/day 8-12 weeks
130015|NCT01837823|E1|Reported Event|Rosuvastatin|All subjects will receive rosuvastatin 40mg/day 8-12 weeks
130016|NCT01837797|B4|Baseline|Total|Total of all reporting groups
129947|NCT01838044|B1|Baseline|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129948|NCT01838044|P2|Participant Flow|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129949|NCT01838044|P1|Participant Flow|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129950|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129951|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129952|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129953|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129954|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129955|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
130017|NCT01837797|B3|Baseline|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 3 mg once daily, tablets, orally"
130018|NCT01837797|B2|Baseline|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1 mg once daily, tablets, orally"
130555|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
129956|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129957|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129958|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129959|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129960|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129961|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129962|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129963|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129964|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
130019|NCT01837797|B1|Baseline|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
130020|NCT01837797|P5|Participant Flow|Period 3 Placebo and ADT|"Placebo adjunct to open-label treatment with commercially available antidepressant treatment (ADT)~Placebo: Once daily, tablets, orally"
130551|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
129965|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129966|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129967|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129968|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129969|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129970|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129971|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129972|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129973|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
130021|NCT01837797|P4|Participant Flow|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
130022|NCT01837797|P3|Participant Flow|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
130495|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
129974|NCT01838044|O1|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129975|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129976|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129977|NCT01838044|E2|Reported Event|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129978|NCT01838044|E1|Reported Event|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
129979|NCT01837966|B3|Baseline|Total|Total of all reporting groups
129980|NCT01837966|B2|Baseline|Placebo|"Placebo - unscented oil aromatherapy~Placebo: 2 drops unscented mineral oil for aromatherapy"
129981|NCT01837966|B1|Baseline|Lavender Oil|"Lavender oil aromatherapy~Lavender oil: 2 drops for aromatherapy"
129982|NCT01837966|P2|Participant Flow|Placebo|"Placebo -- unscented oil aromatherapy~Placebo: 2 drops unscented mineral oil for aromatherapy"
129983|NCT01837966|P1|Participant Flow|Lavender Oil|"Lavender oil aromatherapy~Lavender oil: 2 drops for aromatherapy"
129984|NCT01837966|O2|Outcome|Placebo|"Placebo -- unscented oil aromatherapy~Placebo: 2 drops unscented mineral oil for aromatherapy~There were no adverse events for this arm."
129985|NCT01837966|O1|Outcome|Lavender Oil|"Lavender oil aromatherapy~Lavender oil: 2 drops for aromatherapy~There were no adverse events for this arm."
129986|NCT01837966|E2|Reported Event|Placebo|"Placebo -- unscented oil aromatherapy~Placebo: 2 drops unscented mineral oil for aromatherapy~There were no adverse events for this arm."
129987|NCT01837966|E1|Reported Event|Lavender Oil|"Lavender oil aromatherapy~Lavender oil: 2 drops for aromatherapy~There were no adverse events for this arm."
129988|NCT01837823|B1|Baseline|Rosuvastatin|All subjects will receive rosuvastatin 40mg/day 8-12 weeks
129989|NCT01837823|P1|Participant Flow|Rosuvastatin|All subjects will receive rosuvastatin 40mg/day 8-12 weeks
129990|NCT01837823|O1|Outcome|Rosuvastatin|All subjects will receive rosuvastatin 40mg/day 8-12 weeks
129991|NCT01837823|O1|Outcome|Rosuvastatin|All subjects will receive rosuvastatin 40mg/day 8-12 weeks
129992|NCT01837823|O1|Outcome|Rosuvastatin|All subjects will receive rosuvastatin 40mg/day 8-12 weeks
129993|NCT01837823|O2|Outcome|8-12 Weeks|After 8-12 weeks of rosuvastatin
129994|NCT01837823|O1|Outcome|Baseline|Prior to rosuvastatin therapy
129995|NCT01837823|O2|Outcome|Hp1-1/Hp 1-2|Hp1-1 or Hp 102 genotype
129996|NCT01837823|O1|Outcome|Hp2-2|Hp2-2 genotype
129997|NCT01837823|O1|Outcome|Rosuvastatin|All subjects will receive rosuvastatin 40mg/day 8-12 weeks
129998|NCT01837823|O1|Outcome|Rosuvastatin|All subjects will receive rosuvastatin 40mg/day 8-12 weeks
129999|NCT01837823|O2|Outcome|8-12 Weeks|After 8-12 weeks of rosuvastatin
130000|NCT01837823|O1|Outcome|Baseline|Prior to rosuvastatin therapy
130001|NCT01837823|O2|Outcome|8-12 Weeks|After 8-12 weeks of rosuvastatin
130002|NCT01837823|O1|Outcome|Baseline|Prior to rosuvastatin therapy
130003|NCT01837823|O2|Outcome|8-12 Weeks|After 8-12 weeks of rosuvastatin
130004|NCT01837823|O1|Outcome|Baseline|Prior to rosuvastatin therapy
130005|NCT01837823|O2|Outcome|8-12 Weeks|After 8-12 weeks of rosuvastatin
130006|NCT01837823|O1|Outcome|Baseline|Prior to rosuvastatin therapy
130007|NCT01837823|O2|Outcome|8-12 Weeks|After 8-12 weeks of rosuvastatin
130008|NCT01837823|O1|Outcome|Baseline|Prior to rosuvastatin therapy
130009|NCT01837823|O2|Outcome|8-12 Weeks|After 8-12 weeks of rosuvastatin
130023|NCT01837797|P2|Participant Flow|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
130024|NCT01837797|P1|Participant Flow|Period 1 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
130025|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
130026|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
130027|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
130028|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
130029|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
130030|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
130031|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
130032|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
130033|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
130034|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
130035|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
130036|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
130037|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
130038|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
130039|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
130040|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
130041|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
130042|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
130043|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
130044|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
130045|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
130046|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
130047|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
130048|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
130049|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
130050|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
130051|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
130052|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
130053|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
130054|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
130055|NCT01837797|E3|Reported Event|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 3 mg once daily, tablets, orally"
130056|NCT01837797|E2|Reported Event|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1 mg once daily, tablets, orally"
130057|NCT01837797|E1|Reported Event|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
130085|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
130058|NCT01837719|B1|Baseline|All Participants Who Received Treatment|All participants who received atazanavir with cobicistat in 1 of 8 treatment sequences (ABCDE, ABDCE, BACDE, BADCE, ABCD, ABDC, BACD, or BADC). Treatment A: Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8. Treatment B: Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8. Treatment C: Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22. Treatment D: Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day15 or 29. Treatment E: Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29.
130059|NCT01837719|P1|Participant Flow|All Participants Who Received Treatment|All participants who received atazanavir with cobicistat in 1 of 8 treatment sequences (ABCDE, ABDCE, BACDE, BADCE, ABCD, ABDC, BACD, or BADC). Treatment A: Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat, 150 mg as tablet, following a light meal on Day 1 or 8. Treatment B: Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8. Treatment C: Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day15 or 22. Treatment D: Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22. Treatment E: Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29.
130060|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
130061|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
130062|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
130063|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
130064|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
130065|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high fat meal on Day 29
130066|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day15 or 22
130067|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
130068|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
130069|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
130070|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high fat meal on Day 29
130071|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
130072|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
130073|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
130074|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
130075|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high fat meal on Day 29
130076|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day15 or22
130077|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
130078|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
130079|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
130080|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
130081|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
130082|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
130083|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
130084|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
130552|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
130086|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
130087|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
130088|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
130089|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
130090|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
130091|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day15 or 22
130092|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
130093|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
130094|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
130095|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
130096|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
130097|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
130098|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
130099|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
130100|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
130101|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
130102|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
130103|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
130104|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
130105|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
130106|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
130107|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
130108|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
130109|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
130110|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
130111|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
130112|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
130113|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
130114|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
130115|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
130116|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
130117|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
130118|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
130496|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130119|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
130120|NCT01837719|E5|Reported Event|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29.
130121|NCT01837719|E4|Reported Event|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22.
130122|NCT01837719|E3|Reported Event|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22.
130123|NCT01837719|E2|Reported Event|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8.
130124|NCT01837719|E1|Reported Event|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat, 150 mg as tablet, following a light meal on Day 1 or 8.
130125|NCT01837680|B3|Baseline|Total|Total of all reporting groups
130126|NCT01837680|B2|Baseline|Levemir|Insulin detemir (IDet)
130127|NCT01837680|B1|Baseline|Insulin NPH|Insulin neutral protamine Hagedorn
130128|NCT01837680|P2|Participant Flow|Levemir|Insulin detemir (IDet) - Current weight was obtained at the visit and initial daily total insulin dose was determined based on patient weight (in kilograms) and trimester. In the first trimester, patient weight was multiplied by 0.7, in the second trimester by 0.8, and in the third trimester by 0.9 for the total daily dose of insulin (in units). Of the total daily insulin dose, 60% was allotted to the morning total dose of insulin, while the remaining 40% allotted to the evening total dose.
130129|NCT01837680|P1|Participant Flow|Insulin NPH|Insulin neutral protamine Hagedorn (NPH) - Current weight was obtained at the visit and initial daily total insulin dose was determined based on patient weight (in kilograms) and trimester. In the first trimester, patient weight was multiplied by 0.7, in the second trimester by 0.8, and in the third trimester by 0.9 for the total daily dose of insulin (in units). Of the total daily insulin dose, 60% was allotted to the morning total dose of insulin, while the remaining 40% allotted to the evening total dose.
130130|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
130131|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
130132|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
130133|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
130134|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
130135|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
130136|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
130137|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
130138|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
130139|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
130140|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
130141|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
130142|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
130143|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
130144|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
130145|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
130146|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
130147|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
130148|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
130149|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
130150|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
130151|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
130152|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
130153|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
130154|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
130155|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
130156|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
130157|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
130158|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
130159|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
130160|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
130161|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
130162|NCT01837680|E2|Reported Event|Levemir|Insulin detemir (IDet)
130163|NCT01837680|E1|Reported Event|Insulin NPH|Insulin neutral protamine Hagedorn
130164|NCT01837550|B3|Baseline|Total|Total of all reporting groups
130165|NCT01837550|B2|Baseline|Control Group|"no professional support~Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
130166|NCT01837550|B1|Baseline|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
130167|NCT01837550|P2|Participant Flow|Control Group|"no professional support~Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
130203|NCT01836809|O3|Outcome|LVAD: Nesiritide|"Active arm of the LVAD group~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
130204|NCT01836809|O2|Outcome|Total Artificial Heart: Placebo|Control arm for subjects receiving the Total Artificial Heart and randomized to receive placebo
130168|NCT01837550|P1|Participant Flow|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
130169|NCT01837550|O2|Outcome|Control Group|"no professional support~Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
130170|NCT01837550|O1|Outcome|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
130171|NCT01837550|O2|Outcome|Control Group|"no professional support~Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
130172|NCT01837550|O1|Outcome|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
130173|NCT01837550|O2|Outcome|Control Group|"no professional support~Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
130174|NCT01837550|O1|Outcome|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
130175|NCT01837550|O2|Outcome|Control Group|"no professional support~Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
130176|NCT01837550|O1|Outcome|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
130177|NCT01837550|E2|Reported Event|Control Group|"no professional support~Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
130178|NCT01837550|E1|Reported Event|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
130179|NCT01837537|B1|Baseline|no Treatment|no treatment, prospective observational
130180|NCT01837537|P1|Participant Flow|no Treatment|no treatment, prospective observational
130181|NCT01837537|O1|Outcome|no Treatment|no treatment, prospective observational
130182|NCT01837537|O1|Outcome|no Treatment|no treatment, prospective observational
130183|NCT01837537|E1|Reported Event|no Treatment|no treatment, prospective observational
130184|NCT01837524|B3|Baseline|Total|Total of all reporting groups
130185|NCT01837524|B2|Baseline|Office-Based Visit Arm|"27 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted at one of our medical office buildings. These in-person visits were conducted monthly over a 3 month period. The information delivered in the visits will included how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.~In-Office Dietitian Visits: Participants will have 3, 1 hour in-office sessions with the dietitian during which targeted curriculum on nutritional knowledge, weight management, healthier eating, menu and label reading, will be delivered. These visits will take place monthly over a three month period."
130186|NCT01837524|B1|Baseline|Grocery-Store-Based Visit Arm|"28 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted during grocery shopping trips at a local supermarket. These in-person visits were to be conducted monthly over a 3 month period. The information delivered in the visits was similar in content to that delivered in an in-office visit, including how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.~KP Personal Shopper Visits: Testing co-shopping visits conducted in the grocery store (1:1 visits with dietitian while grocery shopping) versus in-office visits which are the current standard of care."
130205|NCT01836809|O1|Outcome|Total Artificial Heart|"Nesiritide~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
157753|NCT01717989|O1|Outcome|December 2010|
130187|NCT01837524|P2|Participant Flow|Office-Based Visit Arm|"27 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted at one of our medical office buildings. These in-person visits were conducted monthly over a 3 month period. The information delivered in the visits will included how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.~In-Office Dietitian Visits: Participants will have 3, 1 hour in-office sessions with the dietitian during which targeted curriculum on nutritional knowledge, weight management, healthier eating, menu and label reading, will be delivered. These visits will take place monthly over a three month period."
130188|NCT01837524|P1|Participant Flow|Grocery-Store-Based Visit Arm|"28 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted during grocery shopping trips at a local supermarket. These in-person visits were to be conducted monthly over a 3 month period. The information delivered in the visits was similar in content to that delivered in an in-office visit, including how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.~KP Personal Shopper Visits: Testing co-shopping visits conducted in the grocery store (1:1 visits with dietitian while grocery shopping) versus in-office visits which are the current standard of care."
130189|NCT01837524|O2|Outcome|Office-Based Visit Arm|"27 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted at one of our medical office buildings. These in-person visits were conducted monthly over a 3 month period. The information delivered in the visits will included how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.~In-Office Dietitian Visits: Participants will have 3, 1 hour in-office sessions with the dietitian during which targeted curriculum on nutritional knowledge, weight management, healthier eating, menu and label reading, will be delivered. These visits will take place monthly over a three month period."
130190|NCT01837524|O1|Outcome|Grocery-Store-Based Visit Arm|"28 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted during grocery shopping trips at a local supermarket. These in-person visits were to be conducted monthly over a 3 month period. The information delivered in the visits was similar in content to that delivered in an in-office visit, including how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.~KP Personal Shopper Visits: Testing co-shopping visits conducted in the grocery store (1:1 visits with dietitian while grocery shopping) versus in-office visits which are the current standard of care."
130191|NCT01837524|E2|Reported Event|Office-Based Visit Arm|"27 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted at one of our medical office buildings. These in-person visits were conducted monthly over a 3 month period. The information delivered in the visits will included how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.~In-Office Dietitian Visits: Participants will have 3, 1 hour in-office sessions with the dietitian during which targeted curriculum on nutritional knowledge, weight management, healthier eating, menu and label reading, will be delivered. These visits will take place monthly over a three month period."
130192|NCT01837524|E1|Reported Event|Grocery-Store-Based Visit Arm|"28 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted during grocery shopping trips at a local supermarket. These in-person visits were to be conducted monthly over a 3 month period. The information delivered in the visits was similar in content to that delivered in an in-office visit, including how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.~KP Personal Shopper Visits: Testing co-shopping visits conducted in the grocery store (1:1 visits with dietitian while grocery shopping) versus in-office visits which are the current standard of care."
130193|NCT01836809|B5|Baseline|Total|Total of all reporting groups
130194|NCT01836809|B4|Baseline|LVAD: Placebo|"Control arm of the LVAD group~randomized to placebo"
130195|NCT01836809|B3|Baseline|LVAD: Nesiritide|"Active arm of the LVAD group~randomized to nesiritide"
130196|NCT01836809|B2|Baseline|Total Artificial Heart: Placebo|"Total Artificial Heart group~randomized to placebo"
130197|NCT01836809|B1|Baseline|Total Artificial Heart|"Active arm of the Total Artificial Heart group~randomized to nesiritide"
130198|NCT01836809|P4|Participant Flow|LVAD: Placebo|This arm will consist of subjects who received an LVAD and will be randomized to placebo
130199|NCT01836809|P3|Participant Flow|LVAD: Nesiritide|"Active arm of the LVAD group~randomized to receive nesiritide at 0.005 mcg/kg/min without a bolus"
130200|NCT01836809|P2|Participant Flow|Total Artificial Heart: Placebo|This arm included subject who received a total artificial heart and will be randomized receive placebo
130201|NCT01836809|P1|Participant Flow|Total Artificial Heart|"Active arm of Total Artificial Heart group~randomized to receive nesiritide at 0.005 mcg/kg/min without a bolus"
130202|NCT01836809|O4|Outcome|LVAD: Placebo|Control arm for subjects receiving LVAD and randomized to placebo
130206|NCT01836809|O4|Outcome|LVAD: Placebo|Control arm for subjects receiving LVAD and randomized to placebo
130207|NCT01836809|O3|Outcome|LVAD: Nesiritide|"Active arm of the LVAD group~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
130208|NCT01836809|O2|Outcome|Total Artificial Heart: Placebo|Control arm for subjects receiving the Total Artificial Heart and randomized to receive placebo
130209|NCT01836809|O1|Outcome|Total Artificial Heart|"Nesiritide~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
130210|NCT01836809|O4|Outcome|LVAD: Placebo|Control arm for subjects receiving LVAD and randomized to placebo
130211|NCT01836809|O3|Outcome|LVAD: Nesiritide|"Active arm of the LVAD group~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
130212|NCT01836809|O2|Outcome|Total Artificial Heart: Placebo|Control arm for subjects receiving the Total Artificial Heart and randomized to receive placebo
130213|NCT01836809|O1|Outcome|Total Artificial Heart|"Nesiritide~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
130214|NCT01836809|O4|Outcome|LVAD: Placebo|Control arm for subjects receiving LVAD and randomized to placebo
130215|NCT01836809|O3|Outcome|LVAD: Nesiritide|"Active arm of the LVAD group~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
130216|NCT01836809|O2|Outcome|Total Artificial Heart: Placebo|Control arm for subjects receiving the Total Artificial Heart and randomized to receive placebo
130217|NCT01836809|O1|Outcome|Total Artificial Heart|"Nesiritide~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
130218|NCT01836809|O4|Outcome|LVAD: Placebo|Control arm for subjects receiving LVAD and randomized to placebo
130219|NCT01836809|O3|Outcome|LVAD: Nesiritide|"Active arm of the LVAD group~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
130220|NCT01836809|O2|Outcome|Total Artificial Heart: Placebo|Control arm for subjects receiving the Total Artificial Heart and randomized to receive placebo
130221|NCT01836809|O1|Outcome|Total Artificial Heart|"Nesiritide~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
130222|NCT01836809|O4|Outcome|LVAD: Placebo|"Active arm of the LVAD group~randomized to receive placebo"
130223|NCT01836809|O3|Outcome|LVAD: Nesiritide|"Active arm of the LVAD group~randomized to receive nesiritide"
130224|NCT01836809|O2|Outcome|Total Artificial Heart: Placebo|"Control arm of the Total Artificial Heart group~randomized to receive placebo"
130225|NCT01836809|O1|Outcome|Total Artificial Heart|"Active arm of the Total Artificial Heart group~randomized to receive nesiritide"
130226|NCT01836809|E4|Reported Event|LVAD: Placebo|"Control arm of the LVAD group~randomized to receive placebo"
130227|NCT01836809|E3|Reported Event|LVAD: Nesiritide|"Active arm of the LVAD group~randomized to receive nesiritide at 0.005 mcg/kg/min without a bolus"
130228|NCT01836809|E2|Reported Event|Total Artificial Heart: Placebo|"Control arm of the Total Artificial Heart group~randomized to receive placebo"
130229|NCT01836809|E1|Reported Event|Total Artificial Heart|"Active arm of the Total Artificial Heart group~randomized to receive nesiritide 0.005 mcg/kg/min without bolus"
130230|NCT01836523|B5|Baseline|Total|Total of all reporting groups
130231|NCT01836523|B4|Baseline|Placebo|Subjects received placebo (matched to liraglutide 0.6, 1.2 and 1.8 mg) OD subcutaneously as an add-on to their pre-trial insulin treatment. Placebo 0.1 mL (placebo matched to liraglutide 0.6 mg): Subjects received 0.1 mL liraglutide placebo for 52 weeks. Placebo 0.2 mL (placebo matched to liraglutide 1.2 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL up to week 52. Placebo 0.3 mL (placebo matched to liraglutide 1.8 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL for next 2 weeks and 0.3 mL up to week 52. All the 3 placebo doses were pooled for data analysis.
130232|NCT01836523|B3|Baseline|Liraglutide 1.8 mg|Liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously for 2 weeks (weeks 2-4) followed by 1.8 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
130233|NCT01836523|B2|Baseline|Liraglutide 1.2 mg|Subjects received liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
130234|NCT01836523|B1|Baseline|Liraglutide 0.6 mg|Subjects received liraglutide 0.6 mg once daily (OD) subcutaneously for 52 weeks in addition to their pre-trial insulin treatment.
130235|NCT01836523|P4|Participant Flow|Placebo|Subjects received placebo (matched to liraglutide 0.6, 1.2 and 1.8 mg) OD subcutaneously as an add-on to their pre-trial insulin treatment. Placebo 0.1 mL (placebo matched to liraglutide 0.6 mg): Subjects received 0.1 mL liraglutide placebo for 52 weeks. Placebo 0.2 mL (placebo matched to liraglutide 1.2 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL up to week 52. Placebo 0.3 mL (placebo matched to liraglutide 1.8 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL for next 2 weeks and 0.3 mL up to week 52. All the 3 placebo doses were pooled for data analysis.
130236|NCT01836523|P3|Participant Flow|Liraglutide 1.8 mg|Liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously for 2 weeks (weeks 2-4) followed by 1.8 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
130237|NCT01836523|P2|Participant Flow|Liraglutide 1.2 mg|Subjects received liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
130238|NCT01836523|P1|Participant Flow|Liraglutide 0.6 mg|Subjects received liraglutide 0.6 mg once daily (OD) subcutaneously for 52 weeks in addition to their pre-trial insulin treatment.
130263|NCT01836471|B2|Baseline|Placebo Non-atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
130264|NCT01836471|B1|Baseline|QAW039 450 mg qd Non-atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
157754|NCT01717989|O5|Outcome|December 2011|
130239|NCT01836523|O4|Outcome|Placebo|Subjects received placebo (matched to liraglutide 0.6, 1.2 and 1.8 mg) OD subcutaneously as an add-on to their pre-trial insulin treatment. Placebo 0.1 mL (placebo matched to liraglutide 0.6 mg): Subjects received 0.1 mL liraglutide placebo for 52 weeks. Placebo 0.2 mL (placebo matched to liraglutide 1.2 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL up to week 52. Placebo 0.3 mL (placebo matched to liraglutide 1.8 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL for next 2 weeks and 0.3 mL up to week 52. All the 3 placebo doses were pooled for data analysis.
130240|NCT01836523|O3|Outcome|Liraglutide 1.8 mg|Liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously for 2 weeks (weeks 2-4) followed by 1.8 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
130241|NCT01836523|O2|Outcome|Liraglutide 1.2 mg|Subjects received liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
130242|NCT01836523|O1|Outcome|Liraglutide 0.6 mg|Subjects received liraglutide 0.6 mg once daily (OD) subcutaneously for 52 weeks in addition to their pre-trial insulin treatment.
130243|NCT01836523|O4|Outcome|Placebo|Subjects received placebo (matched to liraglutide 0.6, 1.2 and 1.8 mg) OD subcutaneously as an add-on to their pre-trial insulin treatment. Placebo 0.1 mL (placebo matched to liraglutide 0.6 mg): Subjects received 0.1 mL liraglutide placebo for 52 weeks. Placebo 0.2 mL (placebo matched to liraglutide 1.2 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL up to week 52. Placebo 0.3 mL (placebo matched to liraglutide 1.8 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL for next 2 weeks and 0.3 mL up to week 52. All the 3 placebo doses were pooled for data analysis.
130244|NCT01836523|O3|Outcome|Liraglutide 1.8 mg|Liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously for 2 weeks (weeks 2-4) followed by 1.8 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
130245|NCT01836523|O2|Outcome|Liraglutide 1.2 mg|Subjects received liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
130246|NCT01836523|O1|Outcome|Liraglutide 0.6 mg|Subjects received liraglutide 0.6 mg once daily (OD) subcutaneously for 52 weeks in addition to their pre-trial insulin treatment.
130247|NCT01836523|O4|Outcome|Placebo|Subjects received placebo (matched to liraglutide 0.6, 1.2 and 1.8 mg) OD subcutaneously as an add-on to their pre-trial insulin treatment. Placebo 0.1 mL (placebo matched to liraglutide 0.6 mg): Subjects received 0.1 mL liraglutide placebo for 52 weeks. Placebo 0.2 mL (placebo matched to liraglutide 1.2 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL up to week 52. Placebo 0.3 mL (placebo matched to liraglutide 1.8 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL for next 2 weeks and 0.3 mL up to week 52. All the 3 placebo doses were pooled for data analysis.
130248|NCT01836523|O3|Outcome|Liraglutide 1.8 mg|Liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously for 2 weeks (weeks 2-4) followed by 1.8 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
130249|NCT01836523|O2|Outcome|Liraglutide 1.2 mg|Subjects received liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
130250|NCT01836523|O1|Outcome|Liraglutide 0.6 mg|Subjects received liraglutide 0.6 mg once daily (OD) subcutaneously for 52 weeks in addition to their pre-trial insulin treatment.
130251|NCT01836523|O4|Outcome|Placebo|Subjects received placebo (matched to liraglutide 0.6, 1.2 and 1.8 mg) OD subcutaneously as an add-on to their pre-trial insulin treatment. Placebo 0.1 mL (placebo matched to liraglutide 0.6 mg): Subjects received 0.1 mL liraglutide placebo for 52 weeks. Placebo 0.2 mL (placebo matched to liraglutide 1.2 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL up to week 52. Placebo 0.3 mL (placebo matched to liraglutide 1.8 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL for next 2 weeks and 0.3 mL up to week 52. All the 3 placebo doses were pooled for data analysis.
130252|NCT01836523|O3|Outcome|Liraglutide 1.8 mg|Liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously for 2 weeks (weeks 2-4) followed by 1.8 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
130253|NCT01836523|O2|Outcome|Liraglutide 1.2 mg|Subjects received liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
130254|NCT01836523|O1|Outcome|Liraglutide 0.6 mg|Subjects received liraglutide 0.6 mg once daily (OD) subcutaneously for 52 weeks in addition to their pre-trial insulin treatment.
130255|NCT01836523|E4|Reported Event|Placebo|Subjects received placebo (matched to liraglutide 0.6, 1.2 and 1.8 mg) OD subcutaneously as an add-on to their pre-trial insulin treatment. Placebo 0.1 mL (placebo matched to liraglutide 0.6 mg): Subjects received 0.1 mL liraglutide placebo for 52 weeks. Placebo 0.2 mL (placebo matched to liraglutide 1.2 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL up to week 52. Placebo 0.3 mL (placebo matched to liraglutide 1.8 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL for next 2 weeks and 0.3 mL up to week 52. All the 3 placebo doses were pooled for data analysis.
130256|NCT01836523|E3|Reported Event|Liraglutide 1.8 mg|Liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously for 2 weeks (weeks 2-4) followed by 1.8 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
130257|NCT01836523|E2|Reported Event|Liraglutide 1.2 mg|Subjects received liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
130258|NCT01836523|E1|Reported Event|Liraglutide 0.6 mg|Subjects received liraglutide 0.6 mg once daily (OD) subcutaneously for 52 weeks in addition to their pre-trial insulin treatment.
130259|NCT01836471|B6|Baseline|Total|Total of all reporting groups
130260|NCT01836471|B5|Baseline|Placebo Atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
130261|NCT01836471|B4|Baseline|Fluticasone 150 µg Bid Atopic|Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
130262|NCT01836471|B3|Baseline|QAW039 450 mg qd Atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
130309|NCT01836458|O1|Outcome|Dose 1: 30 mg|Single dose of KAE609 30 mg
130310|NCT01836458|O4|Outcome|Dose 4: 15 mg|Single dose of KAE609 15 mg
130265|NCT01836471|P5|Participant Flow|Placebo Atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
130266|NCT01836471|P4|Participant Flow|Fluticasone 150 µg Bid Atopic|Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
130267|NCT01836471|P3|Participant Flow|QAW039 450 mg qd Atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
130268|NCT01836471|P2|Participant Flow|Placebo Non-atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
130269|NCT01836471|P1|Participant Flow|QAW039 450 mg qd Non-atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
130270|NCT01836471|O5|Outcome|Placebo Atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
130271|NCT01836471|O4|Outcome|Fluticasone 150 µg Bid Atopic|Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
130272|NCT01836471|O3|Outcome|QAW039 450 mg qd Atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
130273|NCT01836471|O2|Outcome|Placebo Non-atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
130274|NCT01836471|O1|Outcome|QAW039 450 mg qd Non-atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
130275|NCT01836471|O5|Outcome|Placebo Atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
130276|NCT01836471|O4|Outcome|Fluticasone 150 µg Bid Atopic|Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
130277|NCT01836471|O3|Outcome|QAW039 450 mg qd Atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
130278|NCT01836471|O2|Outcome|Placebo Non-atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
130279|NCT01836471|O1|Outcome|QAW039 450 mg qd Non-atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
130280|NCT01836471|O5|Outcome|Placebo Atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
130281|NCT01836471|O4|Outcome|Fluticasone 150 µg Bid Atopic|Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
130282|NCT01836471|O3|Outcome|QAW039 450 mg qd Atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
130283|NCT01836471|O2|Outcome|Placebo Non-atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
130284|NCT01836471|O1|Outcome|QAW039 450 mg qd Non-atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
130285|NCT01836471|O3|Outcome|Placebo Atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
130286|NCT01836471|O2|Outcome|Fluticasone 150 µg Bid Atopic|Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
130287|NCT01836471|O1|Outcome|QAW039 450 mg qd Atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
130288|NCT01836471|O2|Outcome|Placebo Non-atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
130289|NCT01836471|O1|Outcome|QAW039 450 mg qd Non-atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
130290|NCT01836471|E3|Reported Event|Placebo|Placebo
130291|NCT01836471|E2|Reported Event|Fluticasone 150 mcg Bid|Fluticasone 150 mcg bid
130292|NCT01836471|E1|Reported Event|QAW039 450 mg qd|QAW039 450 mg qd
130293|NCT01836458|B5|Baseline|Total|Total of all reporting groups
130294|NCT01836458|B4|Baseline|Dose 4: 15 mg|Single dose of KAE609 15 mg
130295|NCT01836458|B3|Baseline|Dose 3: 10 mg|Single dose of KAE609 10 mg
130296|NCT01836458|B2|Baseline|Dose 2: 20 mg|Single dose of KAE609 20 mg
130297|NCT01836458|B1|Baseline|Dose 1: 30 mg|Single dose of KAE609 30 mg
130298|NCT01836458|P4|Participant Flow|Dose 4: 15 mg|Single dose of KAE609 15 mg
130299|NCT01836458|P3|Participant Flow|Dose 3: 10 mg|Single dose of KAE609 10 mg
130300|NCT01836458|P2|Participant Flow|Dose 2: 20 mg|Single dose of KAE609 20 mg
130301|NCT01836458|P1|Participant Flow|Dose 1: 30 mg|Single dose of KAE609 30 mg
130302|NCT01836458|O4|Outcome|Dose 4: 15 mg|Single dose of KAE609 15 mg
130303|NCT01836458|O3|Outcome|Dose 3: 10 mg|Single dose of KAE609 10 mg
130304|NCT01836458|O2|Outcome|Dose 2: 20 mg|Single dose of KAE609 20 mg
130305|NCT01836458|O1|Outcome|Dose 1: 30 mg|Single dose of KAE609 30 mg
130306|NCT01836458|O4|Outcome|Dose 4: 15 mg|Single dose of KAE609 15 mg
130307|NCT01836458|O3|Outcome|Dose 3: 10 mg|Single dose of KAE609 10 mg
130308|NCT01836458|O2|Outcome|Dose 2: 20 mg|Single dose of KAE609 20 mg
130322|NCT01836133|B1|Baseline|Erlotinib 150 mg|Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
130323|NCT01836133|P1|Participant Flow|Erlotinib 150 mg|Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
130324|NCT01836133|O1|Outcome|Erlotinib 150 mg|Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
130325|NCT01836133|O1|Outcome|Erlotinib 150 mg|Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
130326|NCT01836133|O1|Outcome|Erlotinib 150 mg|Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
130327|NCT01836133|E1|Reported Event|Erlotinib 150 mg|Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
130328|NCT01836042|B4|Baseline|Total|Total of all reporting groups
130329|NCT01836042|B3|Baseline|Non-randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group
130330|NCT01836042|B2|Baseline|Randomized Cataract Surgery|Cataract surgery alone, patients randomized to group
130331|NCT01836042|B1|Baseline|Randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients randomized to group
130332|NCT01836042|P3|Participant Flow|Non-randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group
130333|NCT01836042|P2|Participant Flow|Randomized Cataract Surgery|Cataract surgery alone, patients randomized to group
130334|NCT01836042|P1|Participant Flow|Randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients randomized to group
130335|NCT01836042|O3|Outcome|Non-randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group
130336|NCT01836042|O2|Outcome|Randomized Cataract Surgery|Cataract surgery alone, patients randomized to group
130337|NCT01836042|O1|Outcome|Randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients randomized to group
130338|NCT01836042|E3|Reported Event|Non-randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group
130339|NCT01836042|E2|Reported Event|Randomized Cataract Surgery|Cataract surgery alone, patients randomized to group
130340|NCT01836042|E1|Reported Event|Randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients randomized to group
130341|NCT01835912|B1|Baseline|All Study Participants|"Acute: dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)~Acute Placebo: 500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)~Chronic: 3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)~Chronic Placebo: 3 days of 500 milliliters flavoured water and the 4th day 500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)"
130342|NCT01835912|P1|Participant Flow|All Study Participants|"Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic) and their corresponding placebos.~4 arms: Acute, Acute Placebo, Chronic, Chronic Placebo~Acute: 0.5 g/kg of body mass of sodium citrate in 500 millilitres of flavoured water~Acute Placebo: 500 milliliters of flavoured water~Chronic: 3 days of 0.1 g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 millilitres of flavoured water~Chronic Placebo: 3 days of 500 millilitres of flavoured water and 4th day 500 millilitres of flavoured water"
130343|NCT01835912|O4|Outcome|Sodium Citrate Dihydrate Chronic|"3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
130344|NCT01835912|O3|Outcome|Flavoured Water Placebo for Chronic Dosing|500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)
130345|NCT01835912|O2|Outcome|Sodium Citrate Dihydrate Acute|"dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
130346|NCT01835912|O1|Outcome|Flavoured Water Placebo for Acute Dosing|500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)
130347|NCT01835912|O4|Outcome|Sodium Citrate Dihydrate Chronic|"3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
130348|NCT01835912|O3|Outcome|Flavoured Water Placebo for Chronic Dosing|500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)
130349|NCT01835912|O2|Outcome|Sodium Citrate Dihydrate Acute|"dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
130350|NCT01835912|O1|Outcome|Flavoured Water Placebo for Acute Dosing|500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)
130351|NCT01835912|O4|Outcome|Sodium Citrate Dihydrate Chronic|"3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
130352|NCT01835912|O3|Outcome|Flavoured Water Placebo for Chronic Dosing|500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)
130353|NCT01835912|O2|Outcome|Sodium Citrate Dihydrate Acute|"dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
130354|NCT01835912|O1|Outcome|Flavoured Water Placebo for Acute Dosing|500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)
130497|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130355|NCT01835912|E4|Reported Event|Sodium Citrate Dihydrate Chronic|"3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
130356|NCT01835912|E3|Reported Event|Flavoured Water Placebo for Chronic Dosing|500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)
130357|NCT01835912|E2|Reported Event|Sodium Citrate Dihydrate Acute|"dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
130358|NCT01835912|E1|Reported Event|Flavoured Water Placebo for Acute Dosing|500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)
130359|NCT01835899|B4|Baseline|Total|Total of all reporting groups
130360|NCT01835899|B3|Baseline|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
130361|NCT01835899|B2|Baseline|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
130362|NCT01835899|B1|Baseline|Placebo to BI 1015550|Subjects were orally administered twice daily with matching Placebo to BI 1015550 Powder for oral solution (PFOS), to have Volume identical to the active drug of the respective dose group.
130363|NCT01835899|P3|Participant Flow|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
130364|NCT01835899|P2|Participant Flow|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
130365|NCT01835899|P1|Participant Flow|Placebo to BI 1015550|Subjects were orally administered twice daily with matching Placebo to BI 1015550 Powder for oral solution (PFOS), to have Volume identical to the active drug of the respective dose group.
130366|NCT01835899|O2|Outcome|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
130367|NCT01835899|O1|Outcome|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
130368|NCT01835899|O2|Outcome|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
130369|NCT01835899|O1|Outcome|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
130370|NCT01835899|O2|Outcome|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
130371|NCT01835899|O1|Outcome|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
130372|NCT01835899|O2|Outcome|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
130373|NCT01835899|O1|Outcome|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
130374|NCT01835899|O2|Outcome|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
130375|NCT01835899|O1|Outcome|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
130376|NCT01835899|O3|Outcome|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
130377|NCT01835899|O2|Outcome|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
130378|NCT01835899|O1|Outcome|Placebo to BI 1015550|Subjects were orally administered twice daily with matching Placebo to BI 1015550 Powder for oral solution (PFOS), to have Volume identical to the active drug of the respective dose group.
130379|NCT01835899|E3|Reported Event|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
130380|NCT01835899|E2|Reported Event|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
130381|NCT01835899|E1|Reported Event|Placebo to BI 1015550|Subjects were orally administered twice daily with matching Placebo to BI 1015550 Powder for oral solution (PFOS), to have Volume identical to the active drug of the respective dose group.
130382|NCT01835756|B3|Baseline|Total|Total of all reporting groups
130383|NCT01835756|B2|Baseline|Placebo Laser|The Placebo Laser has the same appearance and treatment application as the Erchonia MLS but does not emit any therapeutic light.
130384|NCT01835756|B1|Baseline|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light. The Erchonia MLS is applied to the lower back and hips area for 15 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
130385|NCT01835756|P2|Participant Flow|Placebo Laser|The Placebo Laser has the same appearance as the Erchonia MLS but does not emit any therapeutic light.
130386|NCT01835756|P1|Participant Flow|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light. It is applied to the lower back and hips area for 30 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
130387|NCT01835756|O2|Outcome|Placebo Laser|The Placebo Laser has the same appearance and administration application as the Erchonia MLS but does not emit any therapeutic light.
130388|NCT01835756|O1|Outcome|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light. The Erchonia MLS is applied to the lower back and hips area for 15 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
130389|NCT01835756|O2|Outcome|Placebo Laser|The Placebo Laser has the same appearance and administration application as the Erchonia MLS but does not emit any therapeutic light.
130390|NCT01835756|O1|Outcome|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light. The Erchonia MLS is applied to the lower back and hips area for 15 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
130391|NCT01835756|O2|Outcome|Placebo Laser|The Placebo Laser has the same appearance and administration application as the active Erchonia MLS but does not emit any therapeutic light.
130392|NCT01835756|O1|Outcome|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light, applied to the lower back and hips area for 15 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
130393|NCT01835756|E2|Reported Event|Placebo Laser|The Placebo Laser has the same appearance and administration application as the Erchonia MLS but does not emit any therapeutic light.
130394|NCT01835756|E1|Reported Event|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light applied to the lower back and hips area for 30 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
130395|NCT01835743|B3|Baseline|Total|Total of all reporting groups
130396|NCT01835743|B2|Baseline|Placebo Laser|"The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
130397|NCT01835743|B1|Baseline|Erchonia HPS Laser|"The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
130398|NCT01835743|P2|Participant Flow|Placebo Laser|"The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
130399|NCT01835743|P1|Participant Flow|Erchonia HPS Laser|"The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
130400|NCT01835743|O2|Outcome|Placebo Laser|"The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
130401|NCT01835743|O1|Outcome|Erchonia HPS Laser|"The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
130402|NCT01835743|O2|Outcome|Placebo Laser|"The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
130403|NCT01835743|O1|Outcome|Erchonia HPS Laser|"The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
130404|NCT01835743|E2|Reported Event|Placebo Laser|"The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
130405|NCT01835743|E1|Reported Event|Erchonia HPS Laser|"The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
130406|NCT01835548|B3|Baseline|Total|Total of all reporting groups
130407|NCT01835548|B2|Baseline|Placebo|After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period.
130408|NCT01835548|B1|Baseline|NT0102|After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as oral disintegrating tablet (ODT) once daily for one week during the double-blind treatment period.
130409|NCT01835548|P3|Participant Flow|All Participants|All participants in the study went through the screening/washout period, then received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants stayed on that dose for 1 week during the dose stabilization period before randomization into the double-blind treatment period.
130410|NCT01835548|P2|Participant Flow|Placebo|After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period.
130553|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
130411|NCT01835548|P1|Participant Flow|NT0102|After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as oral disintegrating tablet (ODT) once daily for one week during the double-blind treatment period.
130412|NCT01835548|O3|Outcome|Double-Blind Phase: NT0102|At the end of the stabilization period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as ODT once daily for one week during the double-blind treatment period.
130413|NCT01835548|O2|Outcome|Double-Blind Phase: Placebo|At the end of the stabilization period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period.
130414|NCT01835548|O1|Outcome|Dose Optimization/Stabilization Phase|All participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period).
130415|NCT01835548|O2|Outcome|NT0102|After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as ODT once daily for one week during the double-blind treatment period.
130416|NCT01835548|O1|Outcome|Placebo|After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period.
130417|NCT01835548|O2|Outcome|NT0102|After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as ODT once daily for one week during the double-blind treatment period.
130418|NCT01835548|O1|Outcome|Placebo|After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period.
130419|NCT01835548|O2|Outcome|NT0102|After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as ODT once daily for one week during the double-blind treatment period.
130420|NCT01835548|O1|Outcome|Placebo|After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period.
130421|NCT01835548|O2|Outcome|NT0102|After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as ODT once daily for one week during the double-blind treatment period.
130422|NCT01835548|O1|Outcome|Placebo|After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period.
130423|NCT01835548|O1|Outcome|All Participants|Includes all participants from experimental and placebo comparator arms.
130424|NCT01835548|O1|Outcome|All Participants|Includes all participants from experimental and placebo comparator arms.
130425|NCT01835548|O2|Outcome|NT0102|After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as oral disintegrating tablet (ODT) once daily for one week during the double-blind treatment period.
130426|NCT01835548|O1|Outcome|Placebo|After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period.
130498|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
157755|NCT01717989|O4|Outcome|September 2011|
130427|NCT01835548|E3|Reported Event|Double-Blind Phase: NT0102|At the end of the stabilization period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as ODT once daily for one week during the double-blind treatment period.
130428|NCT01835548|E2|Reported Event|Double-Blind Phase: Placebo|At the end of the stabilization period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period.
130429|NCT01835548|E1|Reported Event|Dose Optimization/Stabilization Phase|All participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period).
130430|NCT01835496|B1|Baseline|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
130431|NCT01835496|P1|Participant Flow|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
130432|NCT01835496|O1|Outcome|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
130433|NCT01835496|O1|Outcome|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
130434|NCT01835496|O1|Outcome|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
130435|NCT01835496|O1|Outcome|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
130436|NCT01835496|O1|Outcome|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
130437|NCT01835496|O1|Outcome|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
130438|NCT01835496|E1|Reported Event|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
130439|NCT01835470|B1|Baseline|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
130440|NCT01835470|P1|Participant Flow|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
130441|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
130442|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
130443|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
130444|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study.
130445|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
130446|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
130447|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
130448|NCT01835470|E1|Reported Event|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study.
130449|NCT01835431|B3|Baseline|Total|Total of all reporting groups
130450|NCT01835431|B2|Baseline|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
130451|NCT01835431|B1|Baseline|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
130452|NCT01835431|P2|Participant Flow|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
130453|NCT01835431|P1|Participant Flow|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
130454|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
130455|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
157756|NCT01717989|O3|Outcome|June 2011|
130456|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
130457|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
130458|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
130459|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
130460|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
130461|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
130462|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
130463|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
130464|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
130465|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
130466|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
130467|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
130468|NCT01835431|E2|Reported Event|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
130469|NCT01835431|E1|Reported Event|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
130470|NCT01835379|B3|Baseline|Total|Total of all reporting groups
130471|NCT01835379|B2|Baseline|Standard|"Standard Care~Standard Care as chosen by the Investigator"
130472|NCT01835379|B1|Baseline|Oasis|"Oasis~Oasis Ultra applied once per week for up to 12 weeks."
130473|NCT01835379|P2|Participant Flow|Standard|"Standard Care~Standard Care as chosen by the Investigator"
130474|NCT01835379|P1|Participant Flow|Oasis|"Oasis~Oasis Ultra applied once per week for up to 12 weeks."
130475|NCT01835379|O2|Outcome|Standard|"Standard Care~Standard Care as chosen by the Investigator"
130476|NCT01835379|O1|Outcome|Oasis|"Oasis~Oasis Ultra applied once per week for up to 12 weeks."
130477|NCT01835379|O2|Outcome|Standard|"Standard Care~Standard Care as chosen by the Investigator"
130478|NCT01835379|O1|Outcome|Oasis|"Oasis~Oasis Ultra applied once per week for up to 12 weeks."
130479|NCT01835379|E2|Reported Event|Standard|"Standard Care~Standard Care as chosen by the Investigator"
130480|NCT01835379|E1|Reported Event|Oasis|"Oasis~Oasis Ultra applied once per week for up to 12 weeks."
130481|NCT01835262|B3|Baseline|Total|Total of all reporting groups
130482|NCT01835262|B2|Baseline|Ketamine Group|"Ketamine Group - - Receiving ketamine at 0.3 mg/given as IVP~Ketamine: Ketamine:0.3 mg/given as IVP"
130483|NCT01835262|B1|Baseline|Morphine|"Morphine Group -- Receiving morphine at 0.1 mg /kg given as IVP~Morphine: Morphine: 0.1 mg /kg given as IVP"
130484|NCT01835262|P2|Participant Flow|Ketamine Group|"Ketamine Group - - Receiving ketamine at 0.3 mg/given as IVP~Ketamine: Ketamine:0.3 mg/given as IVP"
130485|NCT01835262|P1|Participant Flow|Morphine|"Morphine Group -- Receiving morphine at 0.1 mg /kg given as IVP~Morphine: Morphine: 0.1 mg /kg given as IVP"
130486|NCT01835262|O2|Outcome|Ketamine Group|"Ketamine Group - - Receiving ketamine at 0.3 mg/given as IVP~Ketamine: Ketamine:0.3 mg/given as IVP"
130487|NCT01835262|O1|Outcome|Morphine|"Morphine Group -- Receiving morphine at 0.1 mg /kg given as IVP~Morphine: Morphine: 0.1 mg /kg given as IVP"
130488|NCT01835262|E2|Reported Event|Ketamine Group|"Ketamine Group - - Receiving ketamine at 0.3 mg/given as IVP~Ketamine: Ketamine:0.3 mg/given as IVP"
130489|NCT01835262|E1|Reported Event|Morphine|"Morphine Group -- Receiving morphine at 0.1 mg /kg given as IVP~Morphine: Morphine: 0.1 mg /kg given as IVP"
130490|NCT01835132|B1|Baseline|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130491|NCT01835132|P1|Participant Flow|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130492|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130493|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130494|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130499|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130500|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130501|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130502|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130503|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130504|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130505|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130506|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130507|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130508|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130509|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130510|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130511|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130512|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130513|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130514|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130515|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130516|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130517|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130518|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130519|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130520|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130521|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130522|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130523|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130524|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130525|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130526|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130527|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130528|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130529|NCT01835132|E1|Reported Event|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
130530|NCT01835015|B6|Baseline|Total|Total of all reporting groups
130531|NCT01835015|B5|Baseline|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
130532|NCT01835015|B4|Baseline|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
130533|NCT01835015|B3|Baseline|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
130534|NCT01835015|B2|Baseline|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
130535|NCT01835015|B1|Baseline|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
130536|NCT01835015|P5|Participant Flow|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
130537|NCT01835015|P4|Participant Flow|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
130538|NCT01835015|P3|Participant Flow|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
130539|NCT01835015|P2|Participant Flow|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
130540|NCT01835015|P1|Participant Flow|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
130541|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
130542|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
130543|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
130544|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
130545|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
130546|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
130547|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
130548|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
130549|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
157757|NCT01717989|O2|Outcome|March 2011|
130556|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
130557|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
130558|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
130559|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
130560|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
130561|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
130562|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
130563|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
130564|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
130565|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
130566|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
130567|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
130568|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
130569|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
130570|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
130571|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
130572|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
130573|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
130574|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
130575|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
130576|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
130577|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
130578|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
130579|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
130580|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
130581|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
130582|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
130583|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
130584|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
130585|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
130586|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
130587|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
130588|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
130589|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
130590|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
130591|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
130592|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
130593|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
130594|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
130595|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
130596|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
130597|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
130598|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
130599|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
130600|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
130601|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
130602|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
130603|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
130604|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
130605|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
130606|NCT01835015|E6|Reported Event|Pretreatment|Reported prior to the initiation of study treatment
130607|NCT01835015|E5|Reported Event|CLG561, Level E|Reported subsequent to the initiation of treatment
130608|NCT01835015|E4|Reported Event|CLG561, Level D|Reported subsequent to the initiation of treatment
130609|NCT01835015|E3|Reported Event|CLG561, Level C|Reported subsequent to the initiation of treatment
130610|NCT01835015|E2|Reported Event|CLG561, Level B|Reported subsequent to the initiation of treatment
130611|NCT01835015|E1|Reported Event|CLG561, Level A|Reported subsequent to the initiation of treatment
130612|NCT01834651|B1|Baseline|Treatment (Cabozantinib)|"Cabozantinib 60mg orally daily until disease progression~Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression."
130613|NCT01834651|P1|Participant Flow|Treatment (Cabozantinib)|"Cabozantinib 60mg orally daily until disease progression~Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression."
130614|NCT01834651|O1|Outcome|Treatment (Cabozantinib)|"Cabozantinib 60mg orally daily until disease progression~Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression."
130615|NCT01834651|O1|Outcome|Treatment (Cabozantinib)|"Cabozantinib 60mg orally daily until disease progression~Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression."
130616|NCT01834651|O2|Outcome|Treatment (Cabozantinib) VEGF Levels|Carbozantinib 60mg
130617|NCT01834651|O1|Outcome|Treatment (Cabozantinib) HGF Levels|"Cabozantinib 60mg orally daily until disease progression~Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression."
130618|NCT01834651|O1|Outcome|Treatment (Cabozantinib)|"Cabozantinib 60mg orally daily until disease progression~Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression."
130619|NCT01834651|O1|Outcome|Treatment (Cabozantinib)|"Cabozantinib 60mg orally daily until disease progression~Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression."
130620|NCT01834651|O1|Outcome|Treatment (Cabozantinib)|"Cabozantinib 60mg orally daily until disease progression~Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression."
130621|NCT01834651|E1|Reported Event|Treatment (Cabozantinib)|"Cabozantinib 60mg orally daily until disease progression~Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression."
130622|NCT01834586|B1|Baseline|Anesthetic Topical Adhesive Synera|"Anesthetic Topical Adhesive Synera. For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.~For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week.~Anesthetic Topical Adhesive Synera: For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.~For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week"
130623|NCT01834586|P1|Participant Flow|Anesthetic Topical Adhesive Synera|"Anesthetic Topical Adhesive Synera. For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.~For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week.~Anesthetic Topical Adhesive Synera: For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.~For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week"
130624|NCT01834586|O1|Outcome|Anesthetic Topical Adhesive Synera|"Anesthetic Topical Adhesive Synera. For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.~For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week.~Anesthetic Topical Adhesive Synera: For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.~For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week"
130625|NCT01834586|O1|Outcome|Anesthetic Topical Adhesive Synera|"Anesthetic Topical Adhesive Synera. For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.~For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week.~Anesthetic Topical Adhesive Synera: For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.~For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week"
130626|NCT01834586|E1|Reported Event|Anesthetic Topical Adhesive Synera|"Anesthetic Topical Adhesive Synera. For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.~For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week.~Anesthetic Topical Adhesive Synera: For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.~For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week"
130627|NCT01834404|B3|Baseline|Total|Total of all reporting groups
130628|NCT01834404|B2|Baseline|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
130629|NCT01834404|B1|Baseline|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
130630|NCT01834404|P2|Participant Flow|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
130631|NCT01834404|P1|Participant Flow|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
130632|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
130633|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
130634|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
130635|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
130636|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
130637|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
130638|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
130639|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
130640|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
130641|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
130642|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
130643|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
130644|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
130645|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
130646|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
130647|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
130648|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
130649|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
130650|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
130651|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
130652|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
130653|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
130654|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
130655|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
130656|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
130657|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
130725|NCT01833988|O2|Outcome|Usual Care|"Usual Care~Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
130658|NCT01834404|E2|Reported Event|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
130659|NCT01834404|E1|Reported Event|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
130660|NCT01834274|B3|Baseline|Total|Total of all reporting groups
130661|NCT01834274|B2|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
130662|NCT01834274|B1|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
130663|NCT01834274|P2|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
130664|NCT01834274|P1|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
130665|NCT01834274|O2|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
130666|NCT01834274|O1|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
130667|NCT01834274|O2|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
130668|NCT01834274|O1|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
130669|NCT01834274|O2|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
130670|NCT01834274|O1|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
130671|NCT01834274|E2|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
130672|NCT01834274|E1|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
130673|NCT01834261|B3|Baseline|Total|Total of all reporting groups
130674|NCT01834261|B2|Baseline|Placebo, Then Oxytocin|"Healthy adult subjects received several puffs of Syntocinon Placebo Formulation, 40IU, once, prior to MRI and/or MEG scanning.~This group contains subjects who received placebo prior to first scan and oxytocin prior to second scan."
130675|NCT01834261|B1|Baseline|Oxytocin, Then Placebo|"Healthy adult subjects received several puffs of Syntocinon Nasal Spray, 40IU, once, prior to MRI and/or MEG scanning.~This group contains subjects who received oxytocin prior to first scan and placebo prior to second scan."
130676|NCT01834261|P2|Participant Flow|Placebo, Then Oxytocin|Healthy adult subjects who received placebo before their first scan, and oxytocin before their second scan.
130677|NCT01834261|P1|Participant Flow|Oxytocin, Then Placebo|Healthy adult subjects who received oxytocin before their first scan, and placebo before their second scan.
130678|NCT01834261|O2|Outcome|Placebo|Subjects received placebo prior to the scan.
130679|NCT01834261|O1|Outcome|Oxytocin|Subjects received oxytocin prior to the scan.
130680|NCT01834261|O2|Outcome|Placebo|Subjects received placebo prior to the scan.
130681|NCT01834261|O1|Outcome|Oxytocin|Subjects received oxytocin prior to the scan.
130682|NCT01834261|O2|Outcome|Placebo|Subjects received placebo prior to the scan.
130683|NCT01834261|O1|Outcome|Oxytocin|Subjects received oxytocin prior to the scan.
130684|NCT01834261|E2|Reported Event|Placebo, Then Oxytocin|Subjects who received placebo before their first scan, and oxytocin before their second scan.
130685|NCT01834261|E1|Reported Event|Oxytocin, Then Placebo|Subjects who received oxytocin before their first scan, and placebo before their second scan.
130686|NCT01834222|B1|Baseline|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
130687|NCT01834222|P1|Participant Flow|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 milliliter (mL) intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
130688|NCT01834222|O1|Outcome|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
130689|NCT01834222|O1|Outcome|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
130690|NCT01834222|O1|Outcome|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
130691|NCT01834222|O1|Outcome|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
130692|NCT01834222|O1|Outcome|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
130693|NCT01834222|O1|Outcome|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
130694|NCT01834222|E1|Reported Event|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
130695|NCT01834027|B3|Baseline|Total|Total of all reporting groups
130696|NCT01834027|B2|Baseline|No Music|"The patients in this group will have noise-cancelling headphones but no music will be played.~No music: In this group, noise-cancelling headphones will be worn, but no music will be played in PACU"
130697|NCT01834027|B1|Baseline|Jazz Music|"Jazz music will be played through noise-cancelling headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.~Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
130698|NCT01834027|P2|Participant Flow|No Music|"The patients in this group with have headphones but no music will be played.~No music: In this group nu music will be played in PACU"
130699|NCT01834027|P1|Participant Flow|Jazz Music|"Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.~Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
130700|NCT01834027|O2|Outcome|No Music|"The patients in this group with have headphones but no music will be played.~No music: In this group nu music will be played in PACU"
130701|NCT01834027|O1|Outcome|Jazz Music|"Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.~Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
130702|NCT01834027|O2|Outcome|No Music|"The patients in this group with have headphones but no music will be played.~No music: In this group nu music will be played in PACU"
130703|NCT01834027|O1|Outcome|Jazz Music|"Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.~Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
130704|NCT01834027|O2|Outcome|No Music|"The patients in this group with have headphones but no music will be played.~No music: In this group nu music will be played in PACU"
130705|NCT01834027|O1|Outcome|Jazz Music|"Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.~Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
130706|NCT01834027|E2|Reported Event|No Music|"The patients in this group with have headphones but no music will be played.~No music: In this group nu music will be played in PACU"
130707|NCT01834027|E1|Reported Event|Jazz Music|"Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.~Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
130708|NCT01833988|B1|Baseline|All Study Participants|The bionic pancreas (closed loop) will be compared to usual care (subject's own insulin pump) in a crossover design in which each volunteer will serve as his or her own control. Each volunteer will be under closed-loop glucose control for five days and usual camp level of diabetes care for five days in random order with a two day washout period in between.
130709|NCT01833988|P2|Participant Flow|Usual Care Then Bionic Pancreas|"Subjects were campers or counselors between the ages of 12 and 21 years who had at least a 1-year history of type 1 diabetes mellitus and were receiving insulin pump therapy.~In a random cross over design, subjects were assigned to either intervention (5 days on bionic pancreas) or standard care (5 days on insulin pump) with a 2 day washout period in between."
130710|NCT01833988|P1|Participant Flow|Bionic Pancreas Then Usual Care|"Subjects were campers or counselors between the ages of 12 and 21 years who had at least a 1-year history of type 1 diabetes mellitus and were receiving insulin pump therapy.~In a random cross over design, subjects were assigned to either intervention (5 days on bionic pancreas) or standard care (5 days on insulin pump) with a 2 day washout period in between."
130711|NCT01833988|O2|Outcome|Control|
130712|NCT01833988|O1|Outcome|Bionic Pancreas|
130713|NCT01833988|O2|Outcome|Control|
130714|NCT01833988|O1|Outcome|Bionic Pancreas|
130715|NCT01833988|O2|Outcome|Control|
130716|NCT01833988|O1|Outcome|Bionic Pancreas|
130717|NCT01833988|O1|Outcome|All Study Participants|The bionic pancreas (closed loop) will be compared to usual care (subject's own insulin pump) in a crossover design in which each volunteer will serve as his or her own control. Each volunteer will be under closed-loop glucose control for five days and usual camp level of diabetes care for five days in random order with a two day washout period in between.
130718|NCT01833988|O1|Outcome|All Study Participants|The bionic pancreas (closed loop) will be compared to usual care (subject's own insulin pump) in a crossover design in which each volunteer will serve as his or her own control. Each volunteer will be under closed-loop glucose control for five days and usual camp level of diabetes care for five days in random order with a two day washout period in between.
130719|NCT01833988|O2|Outcome|Control|
130720|NCT01833988|O1|Outcome|Bionic Pancreas|
130721|NCT01833988|O2|Outcome|Control|
130722|NCT01833988|O1|Outcome|Bionic Pancreas|
130723|NCT01833988|O2|Outcome|Usual Care|"Usual Care~Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
130724|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas~Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
131107|NCT01831817|P3|Participant Flow|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
130726|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas~Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
130727|NCT01833988|O2|Outcome|Usual Care|"Usual Care~Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
130728|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas~Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
130729|NCT01833988|O2|Outcome|Usual Care|"Usual Care~Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
130730|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas~Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
130731|NCT01833988|O2|Outcome|Usual Care|"Usual Care~Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
130732|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas~Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
130733|NCT01833988|O2|Outcome|Usual Care|"Usual Care~Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
130734|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas~Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
130735|NCT01833988|O1|Outcome|All Study Participants|The bionic pancreas (closed loop) will be compared to usual care (subject's own insulin pump) in a crossover design in which each volunteer will serve as his or her own control. Each volunteer will be under closed-loop glucose control for five days and usual camp level of diabetes care for five days in random order with a two day washout period in between.
130736|NCT01833988|O2|Outcome|Usual Care|"Usual Care~Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
130737|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas~Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
130738|NCT01833988|O1|Outcome|All Study Participants|The bionic pancreas (closed loop) will be compared to usual care (subject's own insulin pump) in a crossover design in which each volunteer will serve as his or her own control. Each volunteer will be under closed-loop glucose control for five days and usual camp level of diabetes care for five days in random order with a two day washout period in between.
130739|NCT01833988|O1|Outcome|All Study Participants|The bionic pancreas (closed loop) will be compared to usual care (subject's own insulin pump) in a crossover design in which each volunteer will serve as his or her own control. Each volunteer will be under closed-loop glucose control for five days and usual camp level of diabetes care for five days in random order with a two day washout period in between.
130740|NCT01833988|O2|Outcome|Control|
130741|NCT01833988|O1|Outcome|Bionic Pancreas|
130742|NCT01833988|O2|Outcome|Usual Care|"Usual Care~Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
130743|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas~Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
130744|NCT01833988|O2|Outcome|Usual Care|"Usual Care~Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
130745|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas~Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
130746|NCT01833988|O2|Outcome|Usual Care|"Usual Care~Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
130747|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas~Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
130748|NCT01833988|O2|Outcome|Usual Care|"Usual Care~Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
130749|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas~Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
130750|NCT01833988|O2|Outcome|Usual Care|"Usual Care~Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
130751|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas~Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
130752|NCT01833988|O2|Outcome|Usual Care|"Usual Care~Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
130753|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas~Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
130754|NCT01833988|O2|Outcome|Usual Care|"Usual Care~Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
130755|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas~Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
130756|NCT01833988|O1|Outcome|Bionic Pancreas|"Subjects were campers or counselors between the ages of 12 and 21 years who had at least a 1-year history of type 1 diabetes mellitus and were receiving insulin pump therapy.~In a random cross over design, subjects were assigned to either intervention (5 days on bionic pancreas) or standard care (5 days on insulin pump) with a 1 day washout period in between."
130757|NCT01833988|O2|Outcome|Standard Care (Insulin Pump)|
130758|NCT01833988|O1|Outcome|Bionic Pancreas|
130759|NCT01833988|O2|Outcome|Control|
130760|NCT01833988|O1|Outcome|Bionic Pancreas|
130761|NCT01833988|E2|Reported Event|Control|
130762|NCT01833988|E1|Reported Event|Bionic Pancreas|
130763|NCT01833936|B3|Baseline|Total|Total of all reporting groups
130774|NCT01833897|O1|Outcome|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
130764|NCT01833936|B2|Baseline|Group 2 -(Inactive) Muscle Stimulator|"Group 2 will receive a placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day.~(inactive) muscle stimulator: A placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day."
130765|NCT01833936|B1|Baseline|Group 1- Compex® Muscle Stimulator|"Group 1 will receive an active muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will use the stimulator for three 20 minute sessions per day.~Compex® muscle stimulator: The Compex® muscle stimulator is a commercially available muscle stimulator that is approved by the Food and Drug Administration (FDA), a governmental body. It is not investigational. The investigational part of this study aims to evaluate if the use of muscle simulation after Achilles tendon surgery will reduce calf atrophy."
130766|NCT01833936|P2|Participant Flow|Group 2 -(Inactive) Muscle Stimulator|"Group 2 will receive a placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day.~(inactive) muscle stimulator: A placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day."
130767|NCT01833936|P1|Participant Flow|Group 1- Compex® Muscle Stimulator|"Group 1 will receive an active muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will use the stimulator for three 20 minute sessions per day.~Compex® muscle stimulator: The Compex® muscle stimulator is a commercially available muscle stimulator that is approved by the Food and Drug Administration (FDA), a governmental body. It is not investigational. The investigational part of this study aims to evaluate if the use of muscle simulation after Achilles tendon surgery will reduce calf atrophy."
130768|NCT01833936|O2|Outcome|Group 2 -(Inactive) Muscle Stimulator|"Group 2 will receive a placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day.~(inactive) muscle stimulator: A placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day."
130769|NCT01833936|O1|Outcome|Group 1- Compex® Muscle Stimulator|"Group 1 will receive an active muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will use the stimulator for three 20 minute sessions per day.~Compex® muscle stimulator: The Compex® muscle stimulator is a commercially available muscle stimulator that is approved by the Food and Drug Administration (FDA), a governmental body. It is not investigational. The investigational part of this study aims to evaluate if the use of muscle simulation after Achilles tendon surgery will reduce calf atrophy."
130770|NCT01833936|E2|Reported Event|Group 2 -(Inactive) Muscle Stimulator|"Group 2 will receive a placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day.~(inactive) muscle stimulator: A placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day."
130771|NCT01833936|E1|Reported Event|Group 1- Compex® Muscle Stimulator|"Group 1 will receive an active muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will use the stimulator for three 20 minute sessions per day.~Compex® muscle stimulator: The Compex® muscle stimulator is a commercially available muscle stimulator that is approved by the Food and Drug Administration (FDA), a governmental body. It is not investigational. The investigational part of this study aims to evaluate if the use of muscle simulation after Achilles tendon surgery will reduce calf atrophy."
130772|NCT01833897|B1|Baseline|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
130773|NCT01833897|P1|Participant Flow|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
130800|NCT01833533|P2|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
130775|NCT01833897|O1|Outcome|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
130776|NCT01833897|O1|Outcome|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
130777|NCT01833897|O1|Outcome|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
130778|NCT01833897|O1|Outcome|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
130779|NCT01833897|E1|Reported Event|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
130780|NCT01833845|B1|Baseline|Ribavirin+HCQ|"Administration of RBV monotherapy for a period of 8 weeks following administration of up to 16 weeks combination therapy with ribavirin(RBV) plus Hydroxychloroquine(HCQ).~Ribavirin: weight-based doses (1000 mg/day administered BID [twice daily] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects > 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.~Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)"
130781|NCT01833845|P1|Participant Flow|Ribavirin+HCQ|"Administration of RBV monotherapy for a period of 8 weeks following administration of up to 16 weeks combination therapy with ribavirin(RBV) plus Hydroxychloroquine(HCQ).~Ribavirin: weight-based doses (1000 mg/day administered BID [twice daily] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects > 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.~Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)"
130782|NCT01833845|O1|Outcome|Ribavirin+HCQ|"Administration of RBV monotherapy for a period of 8 weeks following administration of up to 16 weeks combination therapy with ribavirin(RBV) plus Hydroxychloroquine(HCQ).~Ribavirin: weight-based doses (1000 mg/day administered BID [twice daily] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects > 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.~Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)"
130783|NCT01833845|E1|Reported Event|Ribavirin+HCQ|"Administration of RBV monotherapy for a period of 8 weeks following administration of up to 16 weeks combination therapy with ribavirin(RBV) plus Hydroxychloroquine(HCQ).~Ribavirin: weight-based doses (1000 mg/day administered BID [twice daily] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects > 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.~Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)"
130784|NCT01833741|B1|Baseline|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
130785|NCT01833741|P1|Participant Flow|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
130786|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
130787|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
130788|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
130789|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
130790|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
130791|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
130792|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
130793|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
130794|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
130795|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
130796|NCT01833741|E1|Reported Event|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
130797|NCT01833533|B3|Baseline|Total|Total of all reporting groups
130798|NCT01833533|B2|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
130799|NCT01833533|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
131355|NCT01831258|B1|Baseline|All Study Participants|Participants who were randomized to receive either SensAwake On or SensAwake Off
130801|NCT01833533|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
130802|NCT01833533|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
130803|NCT01833533|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
130804|NCT01833533|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
130805|NCT01833533|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
130806|NCT01833533|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
130807|NCT01833533|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
130808|NCT01833533|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
130809|NCT01833533|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
130810|NCT01833533|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
130811|NCT01833533|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
130812|NCT01833533|E2|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
130813|NCT01833533|E1|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
130814|NCT01833481|B4|Baseline|Total|Total of all reporting groups
130815|NCT01833481|B3|Baseline|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
130816|NCT01833481|B2|Baseline|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
130817|NCT01833481|B1|Baseline|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
130818|NCT01833481|P3|Participant Flow|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
130819|NCT01833481|P2|Participant Flow|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
130820|NCT01833481|P1|Participant Flow|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
130821|NCT01833481|O3|Outcome|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
130822|NCT01833481|O2|Outcome|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
130823|NCT01833481|O1|Outcome|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
130824|NCT01833481|O3|Outcome|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
130825|NCT01833481|O2|Outcome|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
130826|NCT01833481|O1|Outcome|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
130827|NCT01833481|O3|Outcome|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
130828|NCT01833481|O2|Outcome|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
130829|NCT01833481|O1|Outcome|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
130830|NCT01833481|E3|Reported Event|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
130831|NCT01833481|E2|Reported Event|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
130832|NCT01833481|E1|Reported Event|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
130833|NCT01833403|B1|Baseline|Hyperinsulinemic-euglycemic Clamp|"hyperinsulinemic-euglycemic clamp~Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery~Glucose"
130834|NCT01833403|P1|Participant Flow|Hyperinsulinemic-euglycemic Clamp|"hyperinsulinemic-euglycemic clamp~Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery~Glucose"
130835|NCT01833403|O1|Outcome|Measurement of Insulin Sensitivity|"All participants will undergo a hyperinsulinemic-euglycemic clamp to measure insulin sensitivity~Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery"
130836|NCT01833403|O1|Outcome|Hyperinsulinemic-euglycemic Clamp|"hyperinsulinemic-euglycemic clamp~Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery~Glucose"
130837|NCT01833403|E1|Reported Event|Hyperinsulinemic-euglycemic Clamp|"hyperinsulinemic-euglycemic clamp~Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery~Glucose"
130838|NCT01833247|B1|Baseline|Epilepsy Inpatients|Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.
130839|NCT01833247|P1|Participant Flow|Epilepsy Inpatients|Patients who have blood or salivary (or both) levels recorded after a seizure.
130840|NCT01833247|O1|Outcome|Epilepsy Inpatients|Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.
130841|NCT01833247|O1|Outcome|Epilepsy Inpatients|Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.
130842|NCT01833247|O1|Outcome|Epilepsy Inpatients|Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.
130843|NCT01833247|E1|Reported Event|Epilepsy Inpatients|Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.
130844|NCT01833169|B1|Baseline|BKM120|BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
130845|NCT01833169|P1|Participant Flow|BKM120|BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
130846|NCT01833169|O1|Outcome|BKM120|BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
130847|NCT01833169|O1|Outcome|BKM120|BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
130848|NCT01833169|O1|Outcome|BKM120|BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
130849|NCT01833169|O1|Outcome|BKM120|BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
130850|NCT01833169|O1|Outcome|BKM120|BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
130851|NCT01833169|O1|Outcome|BKM120|BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
130852|NCT01833169|O1|Outcome|BKM120|BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
130853|NCT01833169|O1|Outcome|BKM120|BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
130854|NCT01833169|E1|Reported Event|BKM120|BKM120
130855|NCT01833130|B3|Baseline|Total|Total of all reporting groups
130856|NCT01833130|B2|Baseline|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130857|NCT01833130|B1|Baseline|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130858|NCT01833130|P2|Participant Flow|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130859|NCT01833130|P1|Participant Flow|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130860|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130861|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130862|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130863|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130864|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130865|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130866|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130867|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130868|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130869|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130870|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130871|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130872|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130873|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130874|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130875|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130876|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130877|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130878|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130879|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130880|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130881|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130882|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130883|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130884|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130885|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130886|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130887|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130888|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130889|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130890|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130891|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130892|NCT01833130|E2|Reported Event|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130893|NCT01833130|E1|Reported Event|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
130894|NCT01833117|B3|Baseline|Total|Total of all reporting groups
130895|NCT01833117|B2|Baseline|Blink|Blink® Tears, 1 drop instilled in the study eye, single dose
130896|NCT01833117|B1|Baseline|FID 119515A|FID 119515A, 1 drop instilled in the study eye, single dose
130897|NCT01833117|P2|Participant Flow|Blink|Blink® Tears, 1 drop instilled in the study eye, single dose
130898|NCT01833117|P1|Participant Flow|FID 119515A|FID 119515A, 1 drop instilled in the study eye, single dose
130899|NCT01833117|O2|Outcome|Blink|Blink® Tears, 1 drop instilled in the study eye, single dose
130900|NCT01833117|O1|Outcome|FID 119515A|FID 119515A, 1 drop instilled in the study eye, single dose
130901|NCT01833117|O2|Outcome|Blink|Blink® Tears, 1 drop instilled in the study eye, single dose
130902|NCT01833117|O1|Outcome|FID 119515A|FID 119515A, 1 drop instilled in the study eye, single dose
130903|NCT01833117|E2|Reported Event|Blink|Blink® Tears, 1 drop instilled in the study eye, single dose
130904|NCT01833117|E1|Reported Event|FID 119515A|FID 119515A, 1 drop instilled in the study eye, single dose
130905|NCT01833078|B1|Baseline|Ghrelin|ghrelin: ghrelin administration subcutaneously for 7 days
130906|NCT01833078|P1|Participant Flow|Ghrelin|All participants received 7.5 mcg/kg of ghrelin as a once daily subcutaneous dose for seven consecutive days. Days 1, 2 and 7 will be in the research center. Days 3,4,5,and 6 will be self administered at home.
130907|NCT01833078|O1|Outcome|Ghrelin|ghrelin: ghrelin administration subcutaneously for 7 days
130908|NCT01833078|O1|Outcome|Ghrelin|ghrelin: ghrelin administration subcutaneously for 7 days
130909|NCT01833078|E1|Reported Event|Ghrelin|ghrelin: ghrelin administration subcutaneously for 7 days
130910|NCT01833065|B4|Baseline|Total|Total of all reporting groups
130911|NCT01833065|B3|Baseline|PLCBO|Placebo was administered orally in a tablet form.
130912|NCT01833065|B2|Baseline|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form.
130913|NCT01833065|B1|Baseline|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form.
130914|NCT01833065|P5|Participant Flow|PLCBO/EBX 10|Patients in this arm received placebo during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and received Elobixibat 10 mg/day during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
130915|NCT01833065|P4|Participant Flow|EBX 5/PLCBO|Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and received placebo during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
130916|NCT01833065|P3|Participant Flow|EBX 5/EBX 5|Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and also received Elobixibat 5 mg/day during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
130917|NCT01833065|P2|Participant Flow|EBX 10/PLCBO|Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and received placebo during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
130918|NCT01833065|P1|Participant Flow|EBX 10/EBX 10|Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and also received Elobixibat 10 mg/day during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
130919|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
130920|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
130921|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
130922|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
130923|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
130924|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
130925|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
130926|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
130927|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
130928|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
130929|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
130930|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
130931|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
130932|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
130933|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
130934|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
130935|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
130936|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
130937|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
130938|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
130939|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
130940|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
130941|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
130942|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
130943|NCT01833065|E5|Reported Event|PLCBO/EBX 10|Patients in this arm received placebo during the 12-week Treatment Period and received Elobixibat 10 mg/day during the 4-week Withdrawal Period.
130944|NCT01833065|E4|Reported Event|EBX 5/PLCBO|Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period and received placebo during the 4-week Withdrawal Period.
130945|NCT01833065|E3|Reported Event|EBX 5/EBX 5|Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period and also received Elobixibat 5 mg/day during the 4-week Withdrawal Period.
130946|NCT01833065|E2|Reported Event|EBX 10/PLCBO|Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period and received placebo during the 4-week Withdrawal Period.
130947|NCT01833065|E1|Reported Event|EBX 10/EBX 10|Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period and also received Elobixibat 10 mg/day during the 4-week Withdrawal Period.
130948|NCT01832766|B1|Baseline|Entire Study Population|includes groups randomized to receive placebo first or dronabinol 10 mg first
130949|NCT01832766|P2|Participant Flow|Placebo First Then 10 mg Dronabinol|identical capsule given orally once in first intervention period then 1 week washout period then dronabinol 10 mg given orally once in second intervention period
130950|NCT01832766|P1|Participant Flow|Dronabinol 10 mg First Then Placebo|dronabinol 10 mg given oral one dose in first intervention period then 1 week washout period and then placebo given oral in one dose in second intervention period
130951|NCT01832766|O2|Outcome|Placebo|identical capsule given once
130952|NCT01832766|O1|Outcome|Dronabinol|dronabinol 10 mg given oral one dose
130953|NCT01832766|O2|Outcome|Placebo|identical capsule given once
130954|NCT01832766|O1|Outcome|Dronabinol|dronabinol 10 mg given oral one dose
130955|NCT01832766|O2|Outcome|Placebo|identical capsule given once
130956|NCT01832766|O1|Outcome|Dronabinol|dronabinol 10 mg given oral one dose
130957|NCT01832766|E2|Reported Event|Placebo|identical capsule given once
130958|NCT01832766|E1|Reported Event|Dronabinol|dronabinol 10 mg given oral one dose
130959|NCT01832506|B4|Baseline|Total|Total of all reporting groups
130960|NCT01832506|B3|Baseline|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130961|NCT01832506|B2|Baseline|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130962|NCT01832506|B1|Baseline|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130963|NCT01832506|P3|Participant Flow|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130964|NCT01832506|P2|Participant Flow|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130965|NCT01832506|P1|Participant Flow|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 milligram (mg) orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130966|NCT01832506|O1|Outcome|MSC2156119J Combined|All subjects who were administered with MSC2156119J 215 mg, 300mg or 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130967|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130968|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130969|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130970|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130971|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130972|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130973|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130974|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130975|NCT01832506|O1|Outcome|MSC2156119J 200 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130976|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130977|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130978|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130979|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130980|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130981|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130982|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130983|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130984|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130985|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130986|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130987|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130988|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130989|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130990|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130991|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130992|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130993|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130994|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130995|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130996|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130997|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130998|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
130999|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
131000|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
131001|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
131002|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
131003|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
131004|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
131005|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
131006|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
131007|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
131008|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
131009|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
131010|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
131011|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
131012|NCT01832506|E3|Reported Event|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
131013|NCT01832506|E2|Reported Event|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
131014|NCT01832506|E1|Reported Event|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
131015|NCT01832493|B1|Baseline|Cardiac Resynchronization Therapy Patients|All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
131016|NCT01832493|P1|Participant Flow|Cardiac Resynchronization Therapy Patients|All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
131017|NCT01832493|O1|Outcome|Cardiac Resynchronization Therapy|"Patients implanted with a cardiac resynchronization therapy device~Cardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods."
131018|NCT01832493|O1|Outcome|Cardiac Resynchronization Therapy|"Patients implanted with a cardiac resynchronization therapy device~Cardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods."
131019|NCT01832493|O1|Outcome|Cardiac Resynchronization Therapy|"Patients implanted with a cardiac resynchronization therapy device~Cardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods."
131020|NCT01832493|O1|Outcome|Cardiac Resynchronization Therapy|"Patients implanted with a cardiac resynchronization therapy device~Cardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods."
131021|NCT01832493|E1|Reported Event|All Enrolled Patients|Adverse events were collected and are reported for all 50 enrolled patients
131022|NCT01832155|B3|Baseline|Total|Total of all reporting groups
131023|NCT01832155|B2|Baseline|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
131024|NCT01832155|B1|Baseline|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
131025|NCT01832155|P2|Participant Flow|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
131026|NCT01832155|P1|Participant Flow|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
131027|NCT01832155|O1|Outcome|All Participants|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
131028|NCT01832155|O2|Outcome|Yoga Intervention Group|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
131029|NCT01832155|O1|Outcome|Wait-list Control Group|Participants in the control group received the same Hatha yoga program at the end of 8 weeks when the intervention group completed their intervention classes.
131030|NCT01832155|O1|Outcome|Both Groups During Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
131104|NCT01831817|B2|Baseline|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
131031|NCT01832155|O1|Outcome|About the Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
131032|NCT01832155|O1|Outcome|All Participants|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
131033|NCT01832155|O1|Outcome|Class Rentention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
131034|NCT01832155|O2|Outcome|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
131035|NCT01832155|O1|Outcome|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
131036|NCT01832155|O2|Outcome|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
131037|NCT01832155|O1|Outcome|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
131038|NCT01832155|O2|Outcome|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
131039|NCT01832155|O1|Outcome|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
131040|NCT01832155|O2|Outcome|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
131041|NCT01832155|O1|Outcome|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
131042|NCT01832155|O2|Outcome|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
131043|NCT01832155|O1|Outcome|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
131044|NCT01832155|E2|Reported Event|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
131045|NCT01832155|E1|Reported Event|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
131046|NCT01832090|B3|Baseline|Total|Total of all reporting groups
131047|NCT01832090|B2|Baseline|Delayed Treatment|"Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
131048|NCT01832090|B1|Baseline|Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
131105|NCT01831817|B1|Baseline|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
131049|NCT01832090|P2|Participant Flow|Delayed Treatment|"Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
131050|NCT01832090|P1|Participant Flow|Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
131051|NCT01832090|O6|Outcome|6 Months Post-retreatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131052|NCT01832090|O5|Outcome|3 Months Post-retreatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131053|NCT01832090|O4|Outcome|12 Months Post-treatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131054|NCT01832090|O3|Outcome|9 Months Post-treatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131055|NCT01832090|O2|Outcome|6 Months Post-treatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131056|NCT01832090|O1|Outcome|3 Months Post-treatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131057|NCT01832090|O4|Outcome|12 Months Post-treatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131058|NCT01832090|O3|Outcome|9 Months Post-treatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131059|NCT01832090|O2|Outcome|6 Months Post-retreatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131060|NCT01832090|O1|Outcome|3 Months Post-retreatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131061|NCT01832090|O4|Outcome|12 Months Post-treatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131062|NCT01832090|O3|Outcome|9 Months Post-treatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131063|NCT01832090|O2|Outcome|6 Months Post-retreatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131064|NCT01832090|O1|Outcome|3 Months Post-retreatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131065|NCT01832090|O5|Outcome|6 Months Post-retreatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131066|NCT01832090|O4|Outcome|3 Months Post-retreatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131067|NCT01832090|O3|Outcome|6 Months Post-treatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131068|NCT01832090|O2|Outcome|3 Months Post-treatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131069|NCT01832090|O1|Outcome|Baseline: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131070|NCT01832090|O5|Outcome|12 Months Post-treatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131071|NCT01832090|O4|Outcome|9 Months Post-treatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131072|NCT01832090|O3|Outcome|6 Months Post-treatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131073|NCT01832090|O2|Outcome|3 Months Post-treatment: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131074|NCT01832090|O1|Outcome|Baseline: Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131075|NCT01832090|O1|Outcome|Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131076|NCT01832090|O1|Outcome|Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131077|NCT01832090|O2|Outcome|Delayed Treatment|"Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131078|NCT01832090|O1|Outcome|Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131079|NCT01832090|O2|Outcome|Delayed Treatment|"Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131080|NCT01832090|O1|Outcome|Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131081|NCT01832090|O4|Outcome|Age ≥ 60 and Delayed Treatment|"Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131082|NCT01832090|O3|Outcome|Age ≥ 60 and Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131083|NCT01832090|O2|Outcome|Age < 60 and Delayed Treatment|"Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131084|NCT01832090|O1|Outcome|Age < 60 and Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131085|NCT01832090|O2|Outcome|Delayed Treatment|"Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
131086|NCT01832090|O1|Outcome|Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
131087|NCT01832090|O2|Outcome|Delayed Treatment|"Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
131088|NCT01832090|O1|Outcome|Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
131089|NCT01832090|O2|Outcome|Delayed Treatment|"Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131090|NCT01832090|O1|Outcome|Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier."
131091|NCT01832090|E1|Reported Event|Radiesse® Injectable Dermal Filler|"Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)~Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier"
131092|NCT01831934|B3|Baseline|Total|Total of all reporting groups
131093|NCT01831934|B2|Baseline|Control Group|"Fluzone®~Fluzone®"
131094|NCT01831934|B1|Baseline|MELAS Group|"Fluzone®~Fluzone®"
131095|NCT01831934|P2|Participant Flow|Control Group: 18-65 Years of Age|"Fluzone® 2011-2012 Formula~Fluzone® 2011-2012 Formula: Quadrivalent inactivated influenza vaccine given given intramuscularly in 0.5ml doses."
131096|NCT01831934|P1|Participant Flow|MELAS Group:13-60 Years of Age.|"Fluzone® 2011-2012 Formula~Fluzone® 2011-2012 Formula: Quadrivalent inactivated influenza vaccine given given intramuscularly in 0.5ml doses."
131097|NCT01831934|O2|Outcome|Control Group|"Fluzone® 2011-2012 Formula~Fluzone® 2011-2012 Formula: This vaccine is given intramuscularly"
131098|NCT01831934|O1|Outcome|MELAS Group|"Fluzone® 2011-2012 Formula~Fluzone® 2011-2012 Formula: This vaccine is given intramuscularly"
131099|NCT01831934|E2|Reported Event|Control Group|"Fluzone®~Fluzone®"
131100|NCT01831934|E1|Reported Event|MELAS Group|"Fluzone®~Fluzone®"
131101|NCT01831817|B5|Baseline|Total|Total of all reporting groups
131102|NCT01831817|B4|Baseline|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
131103|NCT01831817|B3|Baseline|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
131106|NCT01831817|P4|Participant Flow|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
131108|NCT01831817|P2|Participant Flow|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
131109|NCT01831817|P1|Participant Flow|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
131110|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
131111|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
131112|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
131113|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
131114|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
131115|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
131116|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
131117|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
131118|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
131119|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
131120|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
131121|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
131122|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
131123|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
131124|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
131125|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
131126|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
131127|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
131128|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
131129|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
131130|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
131131|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
131132|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
131133|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
131134|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
131135|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
131136|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
131137|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
131138|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
131139|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
131140|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
131141|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
131142|NCT01831817|E4|Reported Event|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
131143|NCT01831817|E3|Reported Event|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
131144|NCT01831817|E2|Reported Event|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
131145|NCT01831817|E1|Reported Event|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|DDentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
131146|NCT01831791|B1|Baseline|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
131147|NCT01831791|P1|Participant Flow|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
131148|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
131149|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
132283|NCT01827319|P1|Participant Flow|Received TMR and Enrolled in ANGINA RELIEF Registry|
131150|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
131151|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
131152|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
131153|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
131154|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
131155|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
131156|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
131157|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
131158|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
131159|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
131160|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
131161|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
131162|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
131163|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
131164|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
131165|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
131166|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
131167|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
131168|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
131169|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
131170|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
131171|NCT01831791|E1|Reported Event|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
131172|NCT01831765|B4|Baseline|Total|Total of all reporting groups
131173|NCT01831765|B3|Baseline|NovoRapid (Meal)|The subjects in this arm were administered mealtime NovoRapid®/NovoLog®, 100 U/mL in combination with once or twice daily insulin detemir (100 U/mL) in a basal-bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime NovoRapid®/NovoLog® was administered subcutaneously (s.c., under the skin) 0−2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131174|NCT01831765|B2|Baseline|Faster Aspart (Post)|The subjects in this arm were administered postmeal faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal−bolus regimen for an initial 26 weeks treatment period. Postmeal faster aspart was administered subcutaneously (s.c., under the skin) 20 minutes after the start of the meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131175|NCT01831765|B1|Baseline|Faster Aspart (Meal)|The subjects in this arm were administered mealtime faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal−bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime faster aspart was administered subcutaneously (s.c., under the skin) 0−2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131176|NCT01831765|P3|Participant Flow|NovoRapid (Meal)|The subjects in this arm were administered mealtime NovoRapid®/NovoLog®, 100 U/mL in combination with once or twice daily insulin detemir (100 U/mL) in a basal-bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime NovoRapid®/NovoLog® was administered subcutaneously (s.c., under the skin) 0−2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131234|NCT01831466|P1|Participant Flow|Mild/Moderate: Tofacitinib 20 mg/Gram (mg/g) Twice Daily (BID)|Participants with a baseline Calculated Physician’s Global Assessment (PGA-C) score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
131177|NCT01831765|P2|Participant Flow|Faster Aspart (Post)|The subjects in this arm were administered postmeal faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal−bolus regimen for an initial 26 weeks treatment period. Postmeal faster aspart was administered subcutaneously (s.c., under the skin) 20 minutes after the start of the meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131178|NCT01831765|P1|Participant Flow|Faster Aspart (Meal)|The subjects in this arm were administered mealtime faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal−bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime faster aspart was administered subcutaneously (s.c., under the skin) 0−2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131179|NCT01831765|O2|Outcome|NovoRapid (Meal)|The subjects in this arm were administered mealtime NovoRapid®/NovoLog®, 100 U/mL in combination with once or twice daily insulin detemir (100 U/mL) in a basal-bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime NovoRapid®/NovoLog® was administered subcutaneously (s.c., under the skin) 0−2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131180|NCT01831765|O1|Outcome|Faster Aspart (Meal)|The subjects in this arm were administered mealtime faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal−bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime faster aspart was administered subcutaneously (s.c., under the skin) 0−2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131181|NCT01831765|O2|Outcome|NovoRapid (Meal)|The subjects in this arm were administered mealtime NovoRapid®/NovoLog®, 100 U/mL in combination with once or twice daily insulin detemir (100 U/mL) in a basal-bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime NovoRapid®/NovoLog® was administered subcutaneously (s.c., under the skin) 0−2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131182|NCT01831765|O1|Outcome|Faster Aspart (Meal)|The subjects in this arm were administered mealtime faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal−bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime faster aspart was administered subcutaneously (s.c., under the skin) 0−2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131183|NCT01831765|O3|Outcome|NovoRapid (Meal)|The subjects in this arm were administered mealtime NovoRapid®/NovoLog®, 100 U/mL in combination with once or twice daily insulin detemir (100 U/mL) in a basal-bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime NovoRapid®/NovoLog® was administered subcutaneously (s.c., under the skin) 0−2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131184|NCT01831765|O2|Outcome|Faster Aspart (Post)|The subjects in this arm were administered postmeal faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal−bolus regimen for an initial 26 weeks treatment period. Postmeal faster aspart was administered subcutaneously (s.c., under the skin) 20 minutes after the start of the meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131235|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
131236|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
131237|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
131185|NCT01831765|O1|Outcome|Faster Aspart (Meal)|The subjects in this arm were administered mealtime faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal−bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime faster aspart was administered subcutaneously (s.c., under the skin) 0−2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131186|NCT01831765|O3|Outcome|NovoRapid (Meal)|The subjects in this arm were administered mealtime NovoRapid®/NovoLog®, 100 U/mL in combination with once or twice daily insulin detemir (100 U/mL) in a basal-bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime NovoRapid®/NovoLog® was administered subcutaneously (s.c., under the skin) 0−2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131187|NCT01831765|O2|Outcome|Faster Aspart (Post)|The subjects in this arm were administered postmeal faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal−bolus regimen for an initial 26 weeks treatment period. Postmeal faster aspart was administered subcutaneously (s.c., under the skin) 20 minutes after the start of the meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131188|NCT01831765|O1|Outcome|Faster Aspart (Meal)|The subjects in this arm were administered mealtime faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal−bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime faster aspart was administered subcutaneously (s.c., under the skin) 0−2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131189|NCT01831765|O3|Outcome|NovoRapid (Meal)|The subjects in this arm were administered mealtime NovoRapid®/NovoLog®, 100 U/mL in combination with once or twice daily insulin detemir (100 U/mL) in a basal-bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime NovoRapid®/NovoLog® was administered subcutaneously (s.c., under the skin) 0−2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131190|NCT01831765|O2|Outcome|Faster Aspart (Post)|The subjects in this arm were administered postmeal faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal−bolus regimen for an initial 26 weeks treatment period. Postmeal faster aspart was administered subcutaneously (s.c., under the skin) 20 minutes after the start of the meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131191|NCT01831765|O1|Outcome|Faster Aspart (Meal)|The subjects in this arm were administered mealtime faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal−bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime faster aspart was administered subcutaneously (s.c., under the skin) 0−2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131192|NCT01831765|O2|Outcome|NovoRapid (Meal)|The subjects in this arm were administered mealtime NovoRapid®/NovoLog®, 100 U/mL in combination with once or twice daily insulin detemir (100 U/mL) in a basal-bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime NovoRapid®/NovoLog® was administered subcutaneously (s.c., under the skin) 0−2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131238|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
131239|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
131240|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
157758|NCT01717989|O1|Outcome|December 2010|
131193|NCT01831765|O1|Outcome|Faster Aspart (Post)|The subjects in this arm were administered postmeal faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal−bolus regimen for an initial 26 weeks treatment period. Postmeal faster aspart was administered subcutaneously (s.c., under the skin) 20 minutes after the start of the meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131194|NCT01831765|O3|Outcome|NovoRapid (Meal)|The subjects in this arm were administered mealtime NovoRapid®/NovoLog®, 100 U/mL in combination with once or twice daily insulin detemir (100 U/mL) in a basal-bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime NovoRapid®/NovoLog® was administered subcutaneously (s.c., under the skin) 0−2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131195|NCT01831765|O2|Outcome|Faster Aspart (Post)|The subjects in this arm were administered postmeal faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal−bolus regimen for an initial 26 weeks treatment period. Postmeal faster aspart was administered subcutaneously (s.c., under the skin) 20 minutes after the start of the meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131196|NCT01831765|O1|Outcome|Faster Aspart (Meal)|The subjects in this arm were administered mealtime faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal−bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime faster aspart was administered subcutaneously (s.c., under the skin) 0−2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131197|NCT01831765|O3|Outcome|NovoRapid (Meal)|The subjects in this arm were administered mealtime NovoRapid®/NovoLog®, 100 U/mL in combination with once or twice daily insulin detemir (100 U/mL) in a basal-bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime NovoRapid®/NovoLog® was administered subcutaneously (s.c., under the skin) 0−2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131198|NCT01831765|O2|Outcome|Faster Aspart (Post)|The subjects in this arm were administered postmeal faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal−bolus regimen for an initial 26 weeks treatment period. Postmeal faster aspart was administered subcutaneously (s.c., under the skin) 20 minutes after the start of the meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131199|NCT01831765|O1|Outcome|Faster Aspart (Meal)|The subjects in this arm were administered mealtime faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal−bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime faster aspart was administered subcutaneously (s.c., under the skin) 0−2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131200|NCT01831765|E3|Reported Event|NovoRapid (Meal)|The subjects in this arm were administered mealtime NovoRapid®/NovoLog®, 100 U/mL in combination with once or twice daily insulin detemir (100 U/mL) in a basal-bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime NovoRapid®/NovoLog® was administered subcutaneously (s.c., under the skin) 0−2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131241|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
131242|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
131243|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
132284|NCT01827319|O1|Outcome|Received TMR and Enrolled in ANGINA RELIEF Registry|
131201|NCT01831765|E2|Reported Event|Faster Aspart (Post)|The subjects in this arm were administered postmeal faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal−bolus regimen for an initial 26 weeks treatment period. Postmeal faster aspart was administered subcutaneously (s.c., under the skin) 20 minutes after the start of the meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131202|NCT01831765|E1|Reported Event|Faster Aspart (Meal)|The subjects in this arm were administered mealtime faster aspart (100 U/mL) in combination with once or twice daily insulin detemir (100 U/mL) in a basal−bolus regimen for an initial 26 weeks treatment period + a 26-week additional treatment period. Mealtime faster aspart was administered subcutaneously (s.c., under the skin) 0−2 minutes before each main meal. Subjects who, prior to screening, had used the principles of flexible dosing based on the meal carbohydrate content, and who were assessed by the investigator to be adequately trained in this method, were to continue using this method for bolus adjustment during the treatment period. All other subjects were to use a predefined bolus dosing algorithm to adjust the bolus dose during the treatment period. Additional bolus dosing was allowed at the investigator’s recommendation.
131203|NCT01831726|B1|Baseline|TKI258|Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
131204|NCT01831726|P1|Participant Flow|TKI258|Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
131205|NCT01831726|O1|Outcome|TKI258|Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
131206|NCT01831726|O1|Outcome|TKI258|Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
131207|NCT01831726|O1|Outcome|TKI258|Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
131208|NCT01831726|O1|Outcome|TKI258|Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
131209|NCT01831726|E1|Reported Event|TKI258|Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
131210|NCT01831466|B13|Baseline|Total|Total of all reporting groups
131211|NCT01831466|B12|Baseline|Severe: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.
131212|NCT01831466|B11|Baseline|Severe: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
131213|NCT01831466|B10|Baseline|Severe: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
131214|NCT01831466|B9|Baseline|Severe: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks.
131215|NCT01831466|B8|Baseline|Severe: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
131216|NCT01831466|B7|Baseline|Severe: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
131217|NCT01831466|B6|Baseline|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
131218|NCT01831466|B5|Baseline|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
131219|NCT01831466|B4|Baseline|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
131220|NCT01831466|B3|Baseline|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
131221|NCT01831466|B2|Baseline|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
131222|NCT01831466|B1|Baseline|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
131223|NCT01831466|P12|Participant Flow|Severe: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.
131224|NCT01831466|P11|Participant Flow|Severe: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
131225|NCT01831466|P10|Participant Flow|Severe: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
131226|NCT01831466|P9|Participant Flow|Severe: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks.
131227|NCT01831466|P8|Participant Flow|Severe: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
131228|NCT01831466|P7|Participant Flow|Severe: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
131229|NCT01831466|P6|Participant Flow|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
131230|NCT01831466|P5|Participant Flow|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
131231|NCT01831466|P4|Participant Flow|Mild/Moderate: Tofacitinib 20 mg/g Once Daily (QD)|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
131232|NCT01831466|P3|Participant Flow|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
131233|NCT01831466|P2|Participant Flow|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
157759|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
131244|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
131245|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
131246|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
131247|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
131248|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
131249|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
131250|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
131251|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
131252|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
131253|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
131254|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
131255|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
131256|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
131257|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
131258|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
131259|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
131260|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
131261|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
131262|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
131263|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
131264|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
131265|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
131266|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
131267|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
131268|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
131269|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
131270|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
131271|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
131272|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
131273|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
131274|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
131275|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
131276|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
131277|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
131278|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
131279|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
131280|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
131281|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
131282|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
131283|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
131284|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
131285|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
131286|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
131287|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
131288|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
131289|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
131290|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
131291|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
131292|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
131293|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
131294|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
131295|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
131296|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
131297|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
131298|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
131299|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
131300|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
131301|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
131302|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
131303|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
131304|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
131305|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
131306|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
131307|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
131308|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
131309|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
131310|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
131311|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
131312|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
131313|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
131314|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
131315|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
131316|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
131317|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
131318|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
131319|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
131320|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
131321|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
131322|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
131323|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
131324|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
131325|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
131326|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
131327|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
131328|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
131329|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
131330|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
131331|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
131332|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
131333|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
131334|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
131335|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
131336|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
131337|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
131338|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
131339|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
131340|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
131341|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
131342|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
131343|NCT01831466|E12|Reported Event|Severe: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.
131344|NCT01831466|E11|Reported Event|Severe: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
131345|NCT01831466|E10|Reported Event|Severe: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
131346|NCT01831466|E9|Reported Event|Severe: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks.
131347|NCT01831466|E8|Reported Event|Severe: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
131348|NCT01831466|E7|Reported Event|Severe: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
131349|NCT01831466|E6|Reported Event|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
131350|NCT01831466|E5|Reported Event|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
131351|NCT01831466|E4|Reported Event|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
131352|NCT01831466|E3|Reported Event|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
131353|NCT01831466|E2|Reported Event|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
131354|NCT01831466|E1|Reported Event|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
131356|NCT01831258|P2|Participant Flow|SensAwake Off, Then Followed by SensAwake On|The comfort feature 'SensAwake' will be turned off, then followed by on.
131357|NCT01831258|P1|Participant Flow|SensAwake On, Then Followed by SensAwake Off|The comfort feature 'SensAwake' will be turned on, followed by it off.
131358|NCT01831258|O2|Outcome|SensAwake Off|The comfort feature 'SensAwake' will be turned off
131359|NCT01831258|O1|Outcome|SensAwake On|The comfort feature 'SensAwake' will be turned on
131360|NCT01831258|O2|Outcome|SensAwake Off|The comfort feature 'SensAwake' will be turned off
131361|NCT01831258|O1|Outcome|SensAwake On|The comfort feature 'SensAwake' will be turned on
131362|NCT01831258|O2|Outcome|SensAwake Off|The comfort feature 'SensAwake' will be turned off
131363|NCT01831258|O1|Outcome|SensAwake On|The comfort feature 'SensAwake' will be turned on
131364|NCT01831258|O2|Outcome|SensAwake Off|The comfort feature 'SensAwake' will be turned off
131365|NCT01831258|O1|Outcome|SensAwake On|The comfort feature 'SensAwake' will be turned on
131366|NCT01831258|O2|Outcome|SensAwake Off|"The comfort feature 'SensAwake' will be turned off~SensAwake Off"
131367|NCT01831258|O1|Outcome|SensAwake On|"The comfort feature 'SensAwake' will be turned on~SensAwake On"
131368|NCT01831258|O2|Outcome|SensAwake Off|The comfort feature 'SensAwake' will be turned off
131369|NCT01831258|O1|Outcome|SensAwake On|The comfort feature 'SensAwake' will be turned on
131370|NCT01831258|O2|Outcome|SensAwake Off|The comfort feature 'SensAwake' will be turned off
131371|NCT01831258|O1|Outcome|SensAwake On|The comfort feature 'SensAwake' will be turned on
131372|NCT01831258|O2|Outcome|SensAwake Off|The comfort feature 'SensAwake' will be turned off
131373|NCT01831258|O1|Outcome|SensAwake On|The comfort feature 'SensAwake' will be turned on
131374|NCT01831258|O2|Outcome|SensAwake Off|The comfort feature 'SensAwake' will be turned off
131375|NCT01831258|O1|Outcome|SensAwake On|The comfort feature 'SensAwake' will be turned on
131376|NCT01831258|O2|Outcome|SensAwake Off|The comfort feature 'SensAwake' will be turned off
131377|NCT01831258|O1|Outcome|SensAwake On|The comfort feature 'SensAwake' will be turned on
131378|NCT01831258|O2|Outcome|SensAwake Off|The comfort feature 'SensAwake' will be turned off
131379|NCT01831258|O1|Outcome|SensAwake On|The comfort feature 'SensAwake' will be turned on
131380|NCT01831258|E2|Reported Event|SensAwake Off|The comfort feature 'SensAwake' will be turned off
131381|NCT01831258|E1|Reported Event|SensAwake On|The comfort feature 'SensAwake' will be turned on
131382|NCT01831232|B1|Baseline|Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)|"Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~pravastatin sodium: Given PO~idarubicin: Given IV~cytarabine: Given IV~laboratory biomarker analysis: Correlative studies"
131383|NCT01831232|P1|Participant Flow|Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)|"Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~pravastatin sodium: Given PO~idarubicin: Given IV~cytarabine: Given IV~laboratory biomarker analysis: Correlative studies"
131384|NCT01831232|O1|Outcome|Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)|"Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~pravastatin sodium: Given PO~idarubicin: Given IV~cytarabine: Given IV~laboratory biomarker analysis: Correlative studies"
131385|NCT01831232|O1|Outcome|Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)|"Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~pravastatin sodium: Given PO~idarubicin: Given IV~cytarabine: Given IV~laboratory biomarker analysis: Correlative studies"
131386|NCT01831232|O1|Outcome|Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)|"Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~pravastatin sodium: Given PO~idarubicin: Given IV~cytarabine: Given IV~laboratory biomarker analysis: Correlative studies"
131387|NCT01831232|O1|Outcome|Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)|"Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~pravastatin sodium: Given PO~idarubicin: Given IV~cytarabine: Given IV~laboratory biomarker analysis: Correlative studies"
131388|NCT01831232|O1|Outcome|Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)|"Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~pravastatin sodium: Given PO~idarubicin: Given IV~cytarabine: Given IV~laboratory biomarker analysis: Correlative studies"
131389|NCT01831232|O1|Outcome|Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)|"Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~pravastatin sodium: Given PO~idarubicin: Given IV~cytarabine: Given IV~laboratory biomarker analysis: Correlative studies"
131390|NCT01831232|E1|Reported Event|Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)|"Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~pravastatin sodium: Given PO~idarubicin: Given IV~cytarabine: Given IV~laboratory biomarker analysis: Correlative studies"
131391|NCT01831219|B3|Baseline|Total|Total of all reporting groups
157760|NCT01717989|O4|Outcome|Q3 2011|Third quarter (Q3) 2011
131392|NCT01831219|B2|Baseline|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
131393|NCT01831219|B1|Baseline|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
131394|NCT01831219|P2|Participant Flow|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
131395|NCT01831219|P1|Participant Flow|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
131396|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
131397|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
131398|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
131399|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
131400|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
131401|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
131402|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
131403|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
131404|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
131405|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
131406|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
131407|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
131408|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
131409|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
131410|NCT01831219|E2|Reported Event|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
131411|NCT01831219|E1|Reported Event|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical sys...
131412|NCT01831154|B4|Baseline|Total|Total of all reporting groups
131413|NCT01831154|B3|Baseline|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
131414|NCT01831154|B2|Baseline|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
131415|NCT01831154|B1|Baseline|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.~Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
131442|NCT01830972|B1|Baseline|Crossover Participants|"Participants completing the 48-week study (UX001-CL201) were enrolled into Part I of the study:~Part I: participants continued on 6 g/day SA-ER for approximately 6 months~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment 4 times per day [QID]) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
131607|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
157761|NCT01717989|O3|Outcome|Q2 2011|Second quarter (Q2), 2011
131416|NCT01831154|P3|Participant Flow|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
131417|NCT01831154|P2|Participant Flow|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
131418|NCT01831154|P1|Participant Flow|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.~Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
131419|NCT01831154|O3|Outcome|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
131420|NCT01831154|O2|Outcome|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
131421|NCT01831154|O1|Outcome|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.~Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
131422|NCT01831154|O3|Outcome|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
131423|NCT01831154|O2|Outcome|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
131443|NCT01830972|P2|Participant Flow|Naïve Participants|"Treatment naïve participants with GNE myopathy were enrolled into Part II of the study:~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment QID) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
131444|NCT01830972|P1|Participant Flow|Crossover Participants|"Participants completing the 48-week study (UX001-CL201) were enrolled into Part I of the study:~Part I: participants continued on 6 g/day SA-ER for approximately 6 months~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment 4 times per day [QID]) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
131424|NCT01831154|O1|Outcome|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.~Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
131425|NCT01831154|O3|Outcome|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
131426|NCT01831154|O2|Outcome|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
131427|NCT01831154|O1|Outcome|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.~Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
131428|NCT01831154|O3|Outcome|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
131429|NCT01831154|O2|Outcome|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
131430|NCT01831154|O1|Outcome|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.~Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
131431|NCT01831154|O3|Outcome|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
131445|NCT01830972|O2|Outcome|Naïve Participants|"Treatment naïve participants with GNE myopathy were enrolled into Part II of the study:~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment QID) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
131446|NCT01830972|O1|Outcome|Crossover Participants|"Participants completing the 48-week study (UX001-CL201) were enrolled into Part I of the study:~Part I: participants continued on 6 g/day SA-ER for approximately 6 months~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment 4 times per day [QID]) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
157762|NCT01717989|O2|Outcome|Q1 2011|First quarter (Q1), 2011
131432|NCT01831154|O2|Outcome|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
131433|NCT01831154|O1|Outcome|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.~Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
131434|NCT01831154|O3|Outcome|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
131435|NCT01831154|O2|Outcome|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
131436|NCT01831154|O1|Outcome|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.~Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
131437|NCT01831154|E3|Reported Event|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
131438|NCT01831154|E2|Reported Event|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
131439|NCT01831154|E1|Reported Event|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.~Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
131440|NCT01830972|B3|Baseline|Total|Total of all reporting groups
131441|NCT01830972|B2|Baseline|Naïve Participants|"Treatment naïve participants with GNE myopathy were enrolled into Part II of the study:~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment QID) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
131604|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131447|NCT01830972|O2|Outcome|Naïve Participants|"Treatment naïve participants with GNE myopathy were enrolled into Part II of the study:~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment QID) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
131448|NCT01830972|O1|Outcome|Crossover Participants|"Participants completing the 48-week study (UX001-CL201) were enrolled into Part I of the study:~Part I: participants continued on 6 g/day SA-ER for approximately 6 months~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment 4 times per day [QID]) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
131449|NCT01830972|O2|Outcome|Naïve Participants|"Treatment naïve participants with GNE myopathy were enrolled into Part II of the study:~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment QID) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
131450|NCT01830972|O1|Outcome|Crossover Participants|"Participants completing the 48-week study (UX001-CL201) were enrolled into Part I of the study:~Part I: participants continued on 6 g/day SA-ER for approximately 6 months~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment 4 times per day [QID]) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
131451|NCT01830972|O2|Outcome|Naïve Participants|"Treatment naïve participants with GNE myopathy were enrolled into Part II of the study:~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment QID) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
131452|NCT01830972|O1|Outcome|Crossover Participants|"Participants completing the 48-week study (UX001-CL201) were enrolled into Part I of the study:~Part I: participants continued on 6 g/day SA-ER for approximately 6 months~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment 4 times per day [QID]) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
131453|NCT01830972|O2|Outcome|Naïve Participants|"Treatment naïve participants with GNE myopathy were enrolled into Part II of the study:~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment QID) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
131454|NCT01830972|O1|Outcome|Crossover Participants|"Participants completing the 48-week study (UX001-CL201) were enrolled into Part I of the study:~Part I: participants continued on 6 g/day SA-ER for approximately 6 months~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment 4 times per day [QID]) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
131455|NCT01830972|O6|Outcome|Overall: Any Dose|"Participants completing the 48-week study (UX001-CL201) were enrolled into Part I of the study and treatment naïve participants with GNE myopathy were enrolled into Part II of the study:~Part I: participants continued on 6 g/day SA-ER for approximately 6 months~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment 4 times per day [QID]) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
131456|NCT01830972|O5|Outcome|Naïve Participants: 12 g/Day|"Treatment naïve participants with GNE myopathy were enrolled into Part II of the study:~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment QID) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
131457|NCT01830972|O4|Outcome|Naïve Participants: 6 g/Day|"Treatment naïve participants with GNE myopathy were enrolled into Part II of the study:~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment QID) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
131458|NCT01830972|O3|Outcome|Crossover Participants: Any Dose|"Participants completing the 48-week study (UX001-CL201) were enrolled into Part I of the study:~Part I: participants continued on 6 g/day SA-ER for approximately 6 months~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment 4 times per day [QID]) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
131459|NCT01830972|O2|Outcome|Crossover Participants: 12 g/Day|"Participants completing the 48-week study (UX001-CL201) were enrolled into Part I of the study:~Part I: participants continued on 6 g/day SA-ER for approximately 6 months~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment 4 times per day [QID]) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
131460|NCT01830972|O1|Outcome|Crossover Participants; 6 g/Day|"Participants completing the 48-week study (UX001-CL201) were enrolled into Part I of the study:~Part I: participants continued on 6 g/day SA-ER for approximately 6 months~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment 4 times per day [QID]) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
131461|NCT01830972|E6|Reported Event|Overall: Any Dose|"Participants completing the 48-week study (UX001-CL201) were enrolled into Part I of the study and treatment naïve participants with GNE myopathy were enrolled into Part II of the study:~Part I: participants continued on 6 g/day SA-ER for approximately 6 months~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment QID) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
131462|NCT01830972|E5|Reported Event|Naïve Participants: 12 g/Day|"Treatment naïve participants with GNE myopathy were enrolled into Part II of the study:~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment QID) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
131463|NCT01830972|E4|Reported Event|Naïve Participants: 6 g/Day|"Treatment naïve participants with GNE myopathy were enrolled into Part II of the study:~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment QID) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
131464|NCT01830972|E3|Reported Event|Crossover Participants: Any Dose|"Participants completing the 48-week study (UX001-CL201) were enrolled into Part I of the study:~Part I: participants continued on 6 g/day SA-ER for approximately 6 months~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment QID) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
131465|NCT01830972|E2|Reported Event|Crossover Participants: 12 g/Day|"Participants completing the 48-week study (UX001-CL201) were enrolled into Part I of the study:~Part I: participants continued on 6 g/day SA-ER for approximately 6 months~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment QID) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
131466|NCT01830972|E1|Reported Event|Crossover Participants; 6 g/Day|"Participants completing the 48-week study (UX001-CL201) were enrolled into Part I of the study:~Part I: participants continued on 6 g/day SA-ER for approximately 6 months~Part II: 12 g/day SA (1.5 g of SA-ER and 1.5 g of SA-IR treatment QID) for 36 months~Part III: 6 g/day or 12 g/day SA (both SA-ER and SA-IR)~Part IV: 6 g/day or 12 g/day SA (SA-ER only)"
131467|NCT01830933|B3|Baseline|Total|Total of all reporting groups
131468|NCT01830933|B2|Baseline|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.~Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.~BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
131469|NCT01830933|B1|Baseline|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
131470|NCT01830933|P2|Participant Flow|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.~Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.~BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
131471|NCT01830933|P1|Participant Flow|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
131472|NCT01830933|O2|Outcome|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.~Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.~BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
131473|NCT01830933|O1|Outcome|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
131474|NCT01830933|O2|Outcome|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.~Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.~BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
131475|NCT01830933|O1|Outcome|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
131476|NCT01830933|O2|Outcome|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.~Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.~BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
131477|NCT01830933|O1|Outcome|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
131478|NCT01830933|O2|Outcome|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.~Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.~BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
131479|NCT01830933|O1|Outcome|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
131480|NCT01830933|E2|Reported Event|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.~Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.~BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
131481|NCT01830933|E1|Reported Event|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
131482|NCT01830920|B6|Baseline|Total|Total of all reporting groups
131483|NCT01830920|B5|Baseline|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131484|NCT01830920|B4|Baseline|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131485|NCT01830920|B3|Baseline|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131486|NCT01830920|B2|Baseline|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131487|NCT01830920|B1|Baseline|Placebo|"An identical appearing placebo will be administered.~Placebo: A normal saline solution identical in appearance to the active drug solution"
131488|NCT01830920|P5|Participant Flow|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131489|NCT01830920|P4|Participant Flow|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131490|NCT01830920|P3|Participant Flow|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131491|NCT01830920|P2|Participant Flow|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131492|NCT01830920|P1|Participant Flow|Placebo|"An identical appearing placebo will be administered.~Placebo: A normal saline solution identical in appearance to the active drug solution"
131493|NCT01830920|O5|Outcome|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131494|NCT01830920|O4|Outcome|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131495|NCT01830920|O3|Outcome|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131496|NCT01830920|O2|Outcome|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131497|NCT01830920|O1|Outcome|Placebo|"An identical appearing placebo will be administered.~Placebo: A normal saline solution identical in appearance to the active drug solution"
131498|NCT01830920|O5|Outcome|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131499|NCT01830920|O4|Outcome|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131500|NCT01830920|O3|Outcome|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131501|NCT01830920|O2|Outcome|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131502|NCT01830920|O1|Outcome|Placebo|"An identical appearing placebo will be administered.~Placebo: A normal saline solution identical in appearance to the active drug solution"
131503|NCT01830920|O5|Outcome|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131504|NCT01830920|O4|Outcome|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131505|NCT01830920|O3|Outcome|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131506|NCT01830920|O2|Outcome|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131507|NCT01830920|O1|Outcome|Placebo|"An identical appearing placebo will be administered.~Placebo: A normal saline solution identical in appearance to the active drug solution"
131508|NCT01830920|O5|Outcome|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131509|NCT01830920|O4|Outcome|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131510|NCT01830920|O3|Outcome|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131511|NCT01830920|O2|Outcome|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131512|NCT01830920|O1|Outcome|Placebo|"An identical appearing placebo will be administered.~Placebo: A normal saline solution identical in appearance to the active drug solution"
131513|NCT01830920|O5|Outcome|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131514|NCT01830920|O4|Outcome|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131515|NCT01830920|O3|Outcome|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131516|NCT01830920|O2|Outcome|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131517|NCT01830920|O1|Outcome|Placebo|"An identical appearing placebo will be administered.~Placebo: A normal saline solution identical in appearance to the active drug solution"
131518|NCT01830920|O5|Outcome|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131519|NCT01830920|O4|Outcome|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131520|NCT01830920|O3|Outcome|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131521|NCT01830920|O2|Outcome|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131522|NCT01830920|O1|Outcome|Placebo|"An identical appearing placebo will be administered.~Placebo: A normal saline solution identical in appearance to the active drug solution"
131523|NCT01830920|E5|Reported Event|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131524|NCT01830920|E4|Reported Event|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131525|NCT01830920|E3|Reported Event|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131526|NCT01830920|E2|Reported Event|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
131527|NCT01830920|E1|Reported Event|Placebo|"An identical appearing placebo will be administered.~Placebo: A normal saline solution identical in appearance to the active drug solution"
131528|NCT01830881|B3|Baseline|Total|Total of all reporting groups
131529|NCT01830881|B2|Baseline|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131530|NCT01830881|B1|Baseline|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131531|NCT01830881|P2|Participant Flow|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131532|NCT01830881|P1|Participant Flow|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131533|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131534|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131535|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131536|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131537|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131538|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131539|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131540|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131541|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131542|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131543|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131605|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131606|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131544|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131545|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131546|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131547|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131548|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131549|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131550|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131551|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131552|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131553|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131554|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131555|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131556|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131557|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131558|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131559|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131560|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131561|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131562|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131563|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131564|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131565|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131566|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131567|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131568|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131569|NCT01830881|E2|Reported Event|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131570|NCT01830881|E1|Reported Event|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
131571|NCT01830855|B5|Baseline|Total|Total of all reporting groups
131572|NCT01830855|B4|Baseline|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131573|NCT01830855|B3|Baseline|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
131574|NCT01830855|B2|Baseline|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
131575|NCT01830855|B1|Baseline|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
131576|NCT01830855|P4|Participant Flow|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131577|NCT01830855|P3|Participant Flow|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
131578|NCT01830855|P2|Participant Flow|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
131579|NCT01830855|P1|Participant Flow|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
131580|NCT01830855|O3|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
131581|NCT01830855|O2|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
131582|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
131583|NCT01830855|O3|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
131584|NCT01830855|O2|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
131585|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
131586|NCT01830855|O3|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
131587|NCT01830855|O2|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
131588|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
131589|NCT01830855|O3|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule.
131590|NCT01830855|O2|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule.
131591|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
131592|NCT01830855|O3|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
131593|NCT01830855|O2|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
131594|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
131595|NCT01830855|O2|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
131596|NCT01830855|O1|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
131597|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
131598|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
131599|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
131600|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
131601|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
131602|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131603|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131608|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131609|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131610|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131611|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131612|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131613|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131614|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131615|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131616|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131617|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131618|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131619|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131620|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131621|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131622|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131623|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131624|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131625|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131626|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131627|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131628|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131629|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131630|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131631|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131632|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131633|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131634|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131635|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131636|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131637|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131638|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131639|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131640|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131641|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131642|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131643|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131644|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131645|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131646|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131647|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131648|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131649|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131650|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131651|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131652|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131653|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131654|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131655|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131656|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131657|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131658|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131659|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131660|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
157763|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter (Q4) 2010
131661|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131662|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131663|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131664|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131665|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131666|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131667|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131668|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131669|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131670|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131671|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131672|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131673|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
131674|NCT01830855|O3|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
131675|NCT01830855|O2|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
131676|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
131677|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
131678|NCT01830855|E4|Reported Event|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
131679|NCT01830855|E3|Reported Event|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
131680|NCT01830855|E2|Reported Event|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
131681|NCT01830855|E1|Reported Event|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
131682|NCT01830842|B3|Baseline|Total|Total of all reporting groups
131683|NCT01830842|B2|Baseline|Nicotine Withdrawal or Satiety|"Smokers will be measured in a normal satiated condition and following 24-hours of smoking abstinence~satiety: smokers will be measured in a smoking satiated condition~abstinence: smokers will be measured following 24-hours of smoking abstinence"
131684|NCT01830842|B1|Baseline|Nicotine, Placebo|"Nonsmokers will be measured following a nicotine polacrilex lozenge (2mg) on one occasion and placebo on another occasion.~Nicotine polacrilex: nonsmokers will be measured following nicotine administration~Placebo: nonsmokers will be measured following placebo administration"
131685|NCT01830842|P2|Participant Flow|Nicotine Withdrawal or Satiety|"Smokers will be measured in a normal satiated condition and following 24-hours of smoking abstinence~satiety: smokers will be measured in a smoking satiated condition~abstinence: smokers will be measured following 24-hours of smoking abstinence"
131686|NCT01830842|P1|Participant Flow|Nicotine, Placebo|"Nonsmokers will be measured following a nicotine polacrilex lozenge (2mg) on one occasion and placebo on another occasion.~Nicotine polacrilex: nonsmokers will be measured following nicotine administration~Placebo: nonsmokers will be measured following placebo administration"
131687|NCT01830842|O2|Outcome|Smokers|"Smokers will be measured in a normal satiated condition and following 24-hours of smoking abstinence~satiety: smokers will be measured in a smoking satiated condition~abstinence: smokers will be measured following 24-hours of smoking abstinence"
131688|NCT01830842|O1|Outcome|Nonsmokers|"Nonsmokers will be measured following a nicotine polacrilex lozenge (2mg) on one occasion and placebo on another occasion.~Nicotine polacrilex: nonsmokers will be measured following nicotine administration~Placebo: nonsmokers will be measured following placebo administration"
131689|NCT01830842|E2|Reported Event|Nicotine Withdrawal or Satiety|"Smokers will be measured in a normal satiated condition and following 24-hours of smoking abstinence~satiety: smokers will be measured in a smoking satiated condition~abstinence: smokers will be measured following 24-hours of smoking abstinence"
131690|NCT01830842|E1|Reported Event|Nicotine, Placebo|"Nonsmokers will be measured following a nicotine polacrilex lozenge (2mg) on one occasion and placebo on another occasion.~Nicotine polacrilex: nonsmokers will be measured following nicotine administration~Placebo: nonsmokers will be measured following placebo administration"
131691|NCT01830790|B3|Baseline|Total|Total of all reporting groups
131692|NCT01830790|B2|Baseline|AMD Patients|"Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
131693|NCT01830790|B1|Baseline|Healthy Controls|"Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
131694|NCT01830790|P2|Participant Flow|AMD Patients|"Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
131695|NCT01830790|P1|Participant Flow|Healthy Controls|"Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
131696|NCT01830790|O2|Outcome|AMD Patients|"Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
131697|NCT01830790|O1|Outcome|Healthy Controls|"Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
132285|NCT01827319|O1|Outcome|Received TMR and Enrolled in ANGINA RELIEF Registry|
131698|NCT01830790|O2|Outcome|AMD Patients|"Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
131699|NCT01830790|O1|Outcome|Healthy Controls|"Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
131700|NCT01830790|E2|Reported Event|AMD Patients|"Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
131701|NCT01830790|E1|Reported Event|Healthy Controls|"Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
131702|NCT01830699|B3|Baseline|Total|Total of all reporting groups
131703|NCT01830699|B2|Baseline|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.~Rilonacept: 160 mg intra-bursal once"
131704|NCT01830699|B1|Baseline|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.~Corticosteroid (Triamcinolone (Kenalog) )"
131705|NCT01830699|P2|Participant Flow|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.~Rilonacept: 160 mg intra-bursal once"
131706|NCT01830699|P1|Participant Flow|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.~Corticosteroid (Triamcinolone (Kenalog) )"
131707|NCT01830699|O2|Outcome|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.~Rilonacept: 160 mg intra-bursal once"
131708|NCT01830699|O1|Outcome|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.~Corticosteroid (Triamcinolone (Kenalog) )"
131709|NCT01830699|O2|Outcome|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.~Rilonacept: 160 mg intra-bursal once"
131710|NCT01830699|O1|Outcome|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.~Corticosteroid (Triamcinolone (Kenalog) )"
131711|NCT01830699|O2|Outcome|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.~Rilonacept: 160 mg intra-bursal once"
131712|NCT01830699|O1|Outcome|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.~Corticosteroid (Triamcinolone (Kenalog) )"
131713|NCT01830699|E2|Reported Event|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.~Rilonacept: 160 mg intra-bursal once"
131714|NCT01830699|E1|Reported Event|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.~Corticosteroid (Triamcinolone (Kenalog) )"
131715|NCT01830543|B4|Baseline|Total|Total of all reporting groups
131716|NCT01830543|B3|Baseline|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
131717|NCT01830543|B2|Baseline|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
131718|NCT01830543|B1|Baseline|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
131719|NCT01830543|P3|Participant Flow|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
131720|NCT01830543|P2|Participant Flow|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
131796|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131721|NCT01830543|P1|Participant Flow|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
131722|NCT01830543|O3|Outcome|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
131723|NCT01830543|O2|Outcome|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
131724|NCT01830543|O1|Outcome|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
131725|NCT01830543|O3|Outcome|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
131726|NCT01830543|O2|Outcome|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
131727|NCT01830543|O1|Outcome|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
131728|NCT01830543|O3|Outcome|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
131729|NCT01830543|O2|Outcome|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
131730|NCT01830543|O1|Outcome|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
131731|NCT01830543|O3|Outcome|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
131732|NCT01830543|O2|Outcome|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
131733|NCT01830543|O1|Outcome|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
131734|NCT01830543|O3|Outcome|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
131735|NCT01830543|O2|Outcome|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
131736|NCT01830543|O1|Outcome|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
131737|NCT01830543|O3|Outcome|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
131738|NCT01830543|O2|Outcome|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
131739|NCT01830543|O1|Outcome|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
131740|NCT01830543|O3|Outcome|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
131741|NCT01830543|O2|Outcome|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
131742|NCT01830543|O1|Outcome|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
131743|NCT01830543|O3|Outcome|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
131744|NCT01830543|O2|Outcome|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
131745|NCT01830543|O1|Outcome|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
131797|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
132286|NCT01827319|O1|Outcome|Received TMR and Enrolled in ANGINA RELIEF Registry|
131746|NCT01830543|O3|Outcome|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
131747|NCT01830543|O2|Outcome|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
131748|NCT01830543|O1|Outcome|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
131749|NCT01830543|E3|Reported Event|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
131750|NCT01830543|E2|Reported Event|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
131751|NCT01830543|E1|Reported Event|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
131752|NCT01830205|B5|Baseline|Total|Total of all reporting groups
131753|NCT01830205|B4|Baseline|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131754|NCT01830205|B3|Baseline|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
131755|NCT01830205|B2|Baseline|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
131756|NCT01830205|B1|Baseline|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
131757|NCT01830205|P4|Participant Flow|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131758|NCT01830205|P3|Participant Flow|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
131759|NCT01830205|P2|Participant Flow|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
131849|NCT01830140|E1|Reported Event|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
131760|NCT01830205|P1|Participant Flow|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had estimated glomerular filtration rate (eGFR) 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
131761|NCT01830205|O4|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131762|NCT01830205|O3|Outcome|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
131763|NCT01830205|O2|Outcome|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
131764|NCT01830205|O1|Outcome|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
131765|NCT01830205|O4|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131766|NCT01830205|O3|Outcome|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
131767|NCT01830205|O2|Outcome|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
131768|NCT01830205|O1|Outcome|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
131769|NCT01830205|O4|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131770|NCT01830205|O3|Outcome|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
131771|NCT01830205|O2|Outcome|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
131772|NCT01830205|O1|Outcome|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
131773|NCT01830205|O4|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131774|NCT01830205|O3|Outcome|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
131775|NCT01830205|O2|Outcome|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
131776|NCT01830205|O1|Outcome|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
131777|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131778|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131779|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1
131780|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were re-randomized from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131781|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131782|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131783|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131784|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131785|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131786|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131787|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131788|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131789|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131790|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131791|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131792|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131793|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131794|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131795|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131798|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131799|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131800|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131801|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131802|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131803|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131804|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131805|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131806|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131807|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131808|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131809|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131810|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131811|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131812|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131813|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131814|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131815|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131816|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131817|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131818|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1
131819|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131820|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131821|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131822|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131850|NCT01830127|B3|Baseline|Total|Total of all reporting groups
131823|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131824|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1
131825|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131826|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1
131827|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131828|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1
131829|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131830|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131831|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131832|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) < 15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131833|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131834|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131835|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131836|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131837|NCT01830205|E4|Reported Event|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
131838|NCT01830205|E3|Reported Event|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
131839|NCT01830205|E2|Reported Event|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
131840|NCT01830205|E1|Reported Event|Group-A|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
131841|NCT01830140|B3|Baseline|Total|Total of all reporting groups
131842|NCT01830140|B2|Baseline|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
131843|NCT01830140|B1|Baseline|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
131844|NCT01830140|P2|Participant Flow|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
131845|NCT01830140|P1|Participant Flow|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
131846|NCT01830140|O2|Outcome|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
131847|NCT01830140|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
131848|NCT01830140|E2|Reported Event|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
157764|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
131851|NCT01830127|B2|Baseline|Arm2: Child-Pugh B|Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
131852|NCT01830127|B1|Baseline|Arm1: Child-Pugh A|Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
131853|NCT01830127|P2|Participant Flow|Arm2: Child-Pugh B|Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
131854|NCT01830127|P1|Participant Flow|Arm1: Child-Pugh A|Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
131855|NCT01830127|O2|Outcome|Arm2: Child-Pugh B|Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
131856|NCT01830127|O1|Outcome|Arm1: Child-Pugh A|Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
131857|NCT01830127|O2|Outcome|Arm2: Child-Pugh B|Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
131858|NCT01830127|O1|Outcome|Arm1: Child-Pugh A|Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
131859|NCT01830127|E2|Reported Event|Arm2: Child-Pugh B|Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
131860|NCT01830127|E1|Reported Event|Arm1: Child-Pugh A|Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
131861|NCT01829919|B1|Baseline|Brisdelle (Paroxetine Mesylate) Capsules|"Brisdelle (paroxetine mesylate) Capsules~All subjects will receive Brisdelle (paroxetine mesylate) capsules, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
131862|NCT01829919|P1|Participant Flow|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
131863|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
131864|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
131865|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
131866|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
131867|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
131868|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
131869|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
131870|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
131871|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
131872|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
131873|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
131874|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
131875|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
131876|NCT01829919|E1|Reported Event|Brisdelle (Paroxetine Mesylate) Capsules|"Brisdelle (paroxetine mesylate) Capsules~All subjects will receive Brisdelle (paroxetine mesylate) capsules, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
131908|NCT01829477|O1|Outcome|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
131877|NCT01829516|B1|Baseline|All Study Participants|This is a crossover study of 39 moderate to heavy social alcohol users who will receive a single dose 40 IU of intranasal oxytocin followed by 40 IU of placebo or vice versa.
131878|NCT01829516|P2|Participant Flow|Placebo First Then Oxytocin|"14 moderate to heavy social alcohol users received a single dose 40 IU of intranasal placebo followed by a single dose 40 IU of intranasal oxytocin.~NOTE: This is a cross-over design and subjects will participate in both arms."
131879|NCT01829516|P1|Participant Flow|Oxytocin First, Then Placebo|"18 moderate to heavy social alcohol users received a single dose 40 IU of intranasal oxytocin followed by a single dose 40 IU of intranasal placebo.~NOTE: This is a cross-over design and subjects will participate in both arms."
131880|NCT01829516|O2|Outcome|Placebo|In this crossover study, 18 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin followed by a single dose of 40 IU of intranasal placebo and 14 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal placebo followed by 40 IU of intranasal oxytocin, for a total of 32 completed participants.
131881|NCT01829516|O1|Outcome|Oxytocin|In this crossover study, 18 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin followed by a single dose of 40 IU of intranasal placebo and 14 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal placebo followed by 40 IU of intranasal oxytocin, for a total of 32 completed participants.
131882|NCT01829516|O2|Outcome|Placebo|14 moderate to heavy social alcohol users received 40 IU of intranasal placebo followed by 40 IU of intranasal oxytocin and 18 received 40 IU of intranasal oxytocin first followed by 40 IU of intranasal placebo, for a total of 32 participants analyzed.
131883|NCT01829516|O1|Outcome|Oxytocin|18 moderate to heavy social alcohol users received 40 IU of intranasal oxytocin followed by 40 IU of intranasal placebo and 14 received 40 IU of intranasal placebo first followed by 40 IU of intranasal oxytocin, for a total of 32 participants analyzed.
131884|NCT01829516|E2|Reported Event|Placebo|"50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal placebo.~NOTE: This is a cross-over design and subjects will participate in both arms.~Placebo"
131885|NCT01829516|E1|Reported Event|Oxytocin|"50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin.~Oxytocin"
131886|NCT01829503|B1|Baseline|Decitabine + Cytarabine|Participants received decitabine 20mg/m^2 intravenously (IV) for five days followed by cytarabine 100mg/m^2 continuous IV infusion over 24 hours for five days.
131887|NCT01829503|P1|Participant Flow|Decitabine + Cytarabine|Participants received decitabine 20mg/m^2 intravenously (IV) for five days followed by cytarabine 100mg/m^2 continuous IV infusion over 24 hours for five days.
131888|NCT01829503|O1|Outcome|Decitabine + Cytarabine + Maintenance Therapy|Participants received decitabine 20mg/m^2 intravenously (IV) for five days followed by cytarabine 100mg/m^2 continuous IV infusion over 24 hours for five days. Participants also received decitabine 20mg/m^2 IV daily for 5 days to be given as an outpatient (maintenance therapy) until disease progression (at least one cycle).
131889|NCT01829503|O1|Outcome|Decitabine + Cytarabine|Participants received decitabine 20mg/m^2 intravenously (IV) for five days followed by cytarabine 100mg/m^2 continuous IV infusion over 24 hours for five days
131890|NCT01829503|O1|Outcome|Decitabine + Cytarabine|Participants received decitabine 20mg/m^2 intravenously (IV) for five days followed by cytarabine 100mg/m^2 continuous IV infusion over 24 hours for five days.
131891|NCT01829503|O1|Outcome|Decitabine + Cytarabine|Participants received decitabine 20mg/m^2 intravenously (IV) for five days followed by cytarabine 100mg/m^2 continuous IV infusion over 24 hours for five days
131892|NCT01829503|O1|Outcome|Decitabine + Cytarabine|Participants received decitabine 20mg/m^2 intravenously (IV) for five days followed by cytarabine 100mg/m^2 continuous IV infusion over 24 hours for five days.
131893|NCT01829503|O1|Outcome|Decitabine + Cytarabine|Participants received decitabine 20mg/m^2 intravenously (IV) for five days followed by cytarabine 100mg/m^2 continuous IV infusion over 24 hours for five days.
131894|NCT01829503|O1|Outcome|Decitabine + Cytarabine|Participants received decitabine 20mg/m^2 intravenously (IV) for five days followed by cytarabine 100mg/m^2 continuous IV infusion over 24 hours for five days.
131895|NCT01829503|O1|Outcome|Decitabine + Cytarabine|Participants received decitabine 20mg/m^2 intravenously (IV) for five days followed by cytarabine 100mg/m^2 continuous IV infusion over 24 hours for five days.
131896|NCT01829503|O1|Outcome|Decitabine + Cytarabine|Participants received decitabine 20mg/m^2 intravenously (IV) for five days followed by cytarabine 100mg/m^2 continuous IV infusion over 24 hours for five days.
131897|NCT01829503|O1|Outcome|Decitabine + Cytarabine|Participants received decitabine 20mg/m^2 intravenously (IV) for five days followed by cytarabine 100mg/m^2 continuous IV infusion over 24 hours for five days
131898|NCT01829503|O1|Outcome|Decitabine + Cytarabine|Participants received decitabine 20mg/m^2 intravenously (IV) for five days followed by cytarabine 100mg/m^2 continuous IV infusion over 24 hours for five days.
131899|NCT01829503|E1|Reported Event|Decitabine + Cytarabine|Participants received decitabine 20mg/m^2 intravenously (IV) for five days followed by cytarabine 100mg/m^2 continuous IV infusion over 24 hours for five days
131900|NCT01829477|B3|Baseline|Total|Total of all reporting groups
131901|NCT01829477|B2|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
131902|NCT01829477|B1|Baseline|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
131903|NCT01829477|P2|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
131904|NCT01829477|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
131905|NCT01829477|O2|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
131906|NCT01829477|O1|Outcome|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
131907|NCT01829477|O2|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
131909|NCT01829477|O2|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
131910|NCT01829477|O1|Outcome|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
131911|NCT01829477|E2|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
131912|NCT01829477|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
131913|NCT01829464|B4|Baseline|Total|Total of all reporting groups
131914|NCT01829464|B3|Baseline|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
131915|NCT01829464|B2|Baseline|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
131916|NCT01829464|B1|Baseline|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
131917|NCT01829464|P3|Participant Flow|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
131918|NCT01829464|P2|Participant Flow|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
131919|NCT01829464|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
131920|NCT01829464|O3|Outcome|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
131921|NCT01829464|O2|Outcome|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
131922|NCT01829464|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
131923|NCT01829464|O3|Outcome|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
131924|NCT01829464|O2|Outcome|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
131925|NCT01829464|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
131926|NCT01829464|O3|Outcome|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
131927|NCT01829464|O2|Outcome|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
131928|NCT01829464|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
131929|NCT01829464|E3|Reported Event|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
131930|NCT01829464|E2|Reported Event|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
131931|NCT01829464|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
131932|NCT01829399|B3|Baseline|Total|Total of all reporting groups
131933|NCT01829399|B2|Baseline|Saline Ring 1st Visit, Bupivacaine Ring 2nd Visit|On the first visit, a subcutaneous axillary ring of 10 to 15 mL of normal saline was injected 15 minutes prior to tourniquet inflation. On the second visit, a subcutaneous axillary ring of 10 to 15 ml of 0.25% Bupivacaine with epinephrine 1:200,000 was injected 15 minutes prior to tourniquet inflation.
131934|NCT01829399|B1|Baseline|Bupivacaine Ring 1st Visit, Saline Ring 2nd Visit|On the first visit, subcutaneous axillary ring of 10 to 15 ml of 0.25% Bupivacaine with epinephrine 1:200,000 was injected 15 minutes prior to tourniquet inflation. On the second visit, a subcutaneous axillary ring of 10 to 15 ml of saline was injected 15 minutes prior to tourniquet inflation.
131935|NCT01829399|P2|Participant Flow|Saline Ring 1st Visit, Bupivacaine Ring 2nd Visit|Participants received a subcutaneous axillary ring injection with normal saline on the first visit and a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000 on the second visit.
131936|NCT01829399|P1|Participant Flow|Bupivacaine Ring 1st Visit, Saline Ring 2nd Visit|Participants received a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000 on the first visit and a subcutaneous axillary ring injection with saline on the second visit.
131937|NCT01829399|O2|Outcome|Saline Axillary Ring on 1st Visit (Control Group)|On the first visit, a subcutaneous axillary ring of 10 to 15 mL of normal saline was injected 15 minutes prior to tourniquet inflation.
131938|NCT01829399|O1|Outcome|Bupivacaine Ring 1st Visit|On the first visit, a subcutaneous axillary ring of 10 to 15 mL of 0.25% Bupivacaine with epinephrine 1:200,000 was injected 15 minutes prior to tourniquet inflation.
131939|NCT01829399|O2|Outcome|Saline Axillary Ring on 1st Visit (Control Group)|Participants received a subcutaneous axillary ring injection with normal saline.
131940|NCT01829399|O1|Outcome|Bupivacaine Axillary Ring on 1st Visit|Participants received a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000.
131941|NCT01829399|E2|Reported Event|Saline Axillary Ring (Control Group)|Participants received a subcutaneous axillary ring injection with normal saline
131942|NCT01829399|E1|Reported Event|Bupivacaine Axillary Ring|Participants received a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000
131943|NCT01829243|B1|Baseline|Subjects Who Completed the Study|
131944|NCT01829243|P2|Participant Flow|Placebo First, Then Milnacipran|Patients randomized to receive placebo first
131945|NCT01829243|P1|Participant Flow|Milnacipran First, Then Placebo|Patients randomized to receiving milnacipran first.
131946|NCT01829243|O2|Outcome|Placebo|Data is summarize for all patients while they were taking the placebo.
131947|NCT01829243|O1|Outcome|Milnacipran|Data is summarize for all patients while they were taking the Milnacipran.
131948|NCT01829243|O2|Outcome|Placebo|Data is summarize for all patients while they were taking the placebo.
131949|NCT01829243|O1|Outcome|Milnacipran|Data is summarize for all patients while they were taking Milnacipran
131950|NCT01829243|O2|Outcome|Placebo|Data is summarize for all patients while they were taking the placebo.
131951|NCT01829243|O1|Outcome|Milnacipran|Data is summarize for all patients while they were taking Milnacipran.
131952|NCT01829243|O2|Outcome|Placebo|Data is summarize for all patients while they were taking the placebo.
131953|NCT01829243|O1|Outcome|Milnacipran|Data is summarize for all patients while they were taking Milnacipran.
131954|NCT01829243|E2|Reported Event|Placebo|Adverse events in this group occurred while subjects were taking Placebo.
131955|NCT01829243|E1|Reported Event|Milnacipran|Adverse events in this group occurred while subjects were taking Milnacipran.
131956|NCT01829230|B3|Baseline|Total|Total of all reporting groups
131957|NCT01829230|B2|Baseline|Test Lens A|Test lens A from previous study
131958|NCT01829230|B1|Baseline|Test Lens C|Test lens C from previous study
131959|NCT01829230|P2|Participant Flow|Test Lens A|Test lens A from previous study
131960|NCT01829230|P1|Participant Flow|Test Lens C|Test lens C from previous study
131961|NCT01829230|O2|Outcome|Test Lens A|Test lens A from the previous study
131962|NCT01829230|O1|Outcome|Test Lens C|Test lens C from the previous study
131963|NCT01829230|O2|Outcome|Test Lens A|Test lens A from the previous study
131964|NCT01829230|O1|Outcome|Test Lens C|Test lens C from the previous study
131965|NCT01829230|E2|Reported Event|Test Lens A|Test lens A from previous study
131966|NCT01829230|E1|Reported Event|Test Lens C|Test lens C from previous study
131967|NCT01829191|B3|Baseline|Total|Total of all reporting groups
131968|NCT01829191|B2|Baseline|Test Lens C|Test lens will be worn in a daily wear modality
131969|NCT01829191|B1|Baseline|Test Lens A|Test lenses will be worn in a daily wear modality
131970|NCT01829191|P2|Participant Flow|Test Lens C|Test lens will be worn in a daily wear modality
131971|NCT01829191|P1|Participant Flow|Test Lens A|Test lenses will be worn in a daily wear modality
131972|NCT01829191|O2|Outcome|Test Lens C|Test lenses will be worn in a daily wear modality
131973|NCT01829191|O1|Outcome|Test Lens A|Test lenses will be worn in a daily wear modality
131974|NCT01829191|O2|Outcome|Test Lens C|Test lenses will be worn in a daily wear modality
131975|NCT01829191|O1|Outcome|Test Lens A|Test lenses will be worn in a daily wear modality
131976|NCT01829191|E1|Reported Event|All Subjects|All subjects who eligible to participate in the study whether or not randomized to the study arm.
131977|NCT01829165|B3|Baseline|Total|Total of all reporting groups
131978|NCT01829165|B2|Baseline|Sham Treatment|"Sham rTMS was to be delivered for 20 sessions over 4 weeks. Placebo 10Hz rTMS was delivered through sham stimulation electrodes. The rTMS coil was positioned using neuro-navigation based on participants' own fMRI images, mimicking active rTMS treatment. Daily treatment regiments were to 36.5minutes and sham rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sham sessions for adverse events and/or side effects.~Upon completing the sham 20 sessions participants are unblinded and offered 20 further treatments of guaranteed open-label treatment. The open-label treatment would follow the active rTMS treatment protocol.~rTMS Treatment: MRI-compatible TMS stimulator"
131979|NCT01829165|B1|Baseline|rTMS Treatment|"rTMS was to be delivered for 20 sessions over 4 weeks. Active 10 Hz rTMS was delivered using neuro-navigation based on participants' own fMRI images. Daily treatment regiments were to last 36.5 minutes and rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sessions for adverse events and/or side effects.~rTMS Treatment: MRI-compatible TMS stimulator"
131980|NCT01829165|P2|Participant Flow|Sham Treatment|"Sham rTMS was to be delivered for 20 sessions over 4 weeks. Placebo 10Hz rTMS was delivered through sham stimulation electrodes. The rTMS coil was positioned using neuro-navigation based on participants' own fMRI images, mimicking active rTMS treatment. Daily treatment regiments were to 36.5minutes and sham rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sham sessions for adverse events and/or side effects.~Upon completing the sham 20 sessions participants are unblinded and offered 20 further treatments of guaranteed open-label treatment. The open-label treatment would follow the active rTMS treatment protocol.~rTMS Treatment: MRI-compatible TMS stimulator"
131981|NCT01829165|P1|Participant Flow|rTMS Treatment|"Rapid transcranial magnetic stimulation (rTMS) was to be delivered for 20 sessions over 4 weeks. Active 10 Hz rTMS was delivered using neuro-navigation based on participants' own functional magnetic resonance imaging (fMRI) images. Daily treatment regiments were to last 36.5 minutes and rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sessions for adverse events and/or side effects.~rTMS Treatment: MRI-compatible TMS stimulator"
132100|NCT01827839|B1|Baseline|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
157765|NCT01717989|O4|Outcome|Q3 2011|Third quarter (Q3) 2011
131982|NCT01829165|O2|Outcome|Sham Treatment|"Sham rTMS was to be delivered for 20 sessions over 4 weeks. Placebo 10Hz rTMS was delivered through sham stimulation electrodes. The rTMS coil was positioned using neuro-navigation based on participants' own fMRI images, mimicking active rTMS treatment. Daily treatment regiments were to 36.5minutes and sham rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sham sessions for adverse events and/or side effects.~Upon completing the sham 20 sessions participants are unblinded and offered 20 further treatments of guaranteed open-label treatment. The open-label treatment would follow the active rTMS treatment protocol.~rTMS Treatment: MRI-compatible TMS stimulator"
131983|NCT01829165|O1|Outcome|rTMS Treatment|"rTMS was to be delivered for 20 sessions over 4 weeks. Active 10 Hz rTMS was delivered using neuro-navigation based on participants' own fMRI images. Daily treatment regiments were to last 36.5 minutes and rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sessions for adverse events and/or side effects.~rTMS Treatment: MRI-compatible TMS stimulator"
131984|NCT01829165|E2|Reported Event|Sham Treatment|"Sham rTMS was to be delivered for 20 sessions over 4 weeks. Placebo 10Hz rTMS was delivered through sham stimulation electrodes. The rTMS coil was positioned using neuro-navigation based on participants' own fMRI images, mimicking active rTMS treatment. Daily treatment regiments were to 36.5minutes and sham rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sham sessions for adverse events and/or side effects.~Upon completing the sham 20 sessions participants are unblinded and offered 20 further treatments of guaranteed open-label treatment. The open-label treatment would follow the active rTMS treatment protocol.~rTMS Treatment: MRI-compatible TMS stimulator"
131985|NCT01829165|E1|Reported Event|rTMS Treatment|"rTMS was to be delivered for 20 sessions over 4 weeks. Active 10 Hz rTMS was delivered using neuro-navigation based on participants' own fMRI images. Daily treatment regiments were to last 36.5 minutes and rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sessions for adverse events and/or side effects.~rTMS Treatment: MRI-compatible TMS stimulator"
131986|NCT01828983|B3|Baseline|Total|Total of all reporting groups
131987|NCT01828983|B2|Baseline|Education Webinars|Education Webinar session topics are the same that are covered in the intervention arm without telephone interaction/support and skills building components. Each session is 30-minutes. Each participant receives a Spouse Workbook with information and activities.
131988|NCT01828983|B1|Baseline|Telephone Support Groups|Telephone support groups, each with participants and a trained group leader. Each hour-long telephone group will meet bi-monthly for six months for a total of 12 meetings. Groups are structured with education, skills building, and support. Participants will receive and use a Spouse Workbook with information and activities.
131989|NCT01828983|P2|Participant Flow|Education Webinars|Education Webinar session topics are the same that are covered in the intervention arm without telephone interaction/support and skills building components. Each session is 30-minutes. Each participant receives a Spouse Workbook with information and activities.
131990|NCT01828983|P1|Participant Flow|Telephone Support Groups|Telephone support groups, each with participants and a trained group leader. Each hour-long telephone group will meet bi-monthly for six months for a total of 12 meetings. Groups are structured with education, skills building, and support. Participants will receive and use a Spouse Workbook with information and activities.
131991|NCT01828983|O2|Outcome|Education Webinars|Education Webinar session topics are the same that are covered in the intervention arm without telephone interaction/support and skills building components. Each session is 30-minutes. Each participant receives a Spouse Workbook with information and activities.
131992|NCT01828983|O1|Outcome|Telephone Support Groups|Telephone support groups, each with participants and a trained group leader. Each hour-long telephone group will meet bi-monthly for six months for a total of 12 meetings. Groups are structured with education, skills building, and support. Participants will receive and use a Spouse Workbook with information and activities.
131993|NCT01828983|O2|Outcome|Education Webinars|Education Webinar session topics are the same that are covered in the intervention arm without telephone interaction/support and skills building components. Each session is 30-minutes. Each participant receives a Spouse Workbook with information and activities.
131994|NCT01828983|O1|Outcome|Telephone Support Groups|Telephone support groups, each with participants and a trained group leader. Each hour-long telephone group will meet bi-monthly for six months for a total of 12 meetings. Groups are structured with education, skills building, and support. Participants will receive and use a Spouse Workbook with information and activities.
131995|NCT01828983|O2|Outcome|Education Webinars|Education Webinar session topics are the same that are covered in the intervention arm without telephone interaction/support and skills building components. Each session is 30-minutes. Each participant receives a Spouse Workbook with information and activities.
131996|NCT01828983|O1|Outcome|Telephone Support Groups|Telephone support groups, each with participants and a trained group leader. Each hour-long telephone group will meet bi-monthly for six months for a total of 12 meetings. Groups are structured with education, skills building, and support. Participants will receive and use a Spouse Workbook with information and activities.
131997|NCT01828983|E2|Reported Event|Education Webinars|Education Webinar session topics are the same that are covered in the intervention arm without telephone interaction/support and skills building components. Each session is 30-minutes. Each participant receives a Spouse Workbook with information and activities.
131998|NCT01828983|E1|Reported Event|Telephone Support Groups|Telephone support groups, each with participants and a trained group leader. Each hour-long telephone group will meet bi-monthly for six months for a total of 12 meetings. Groups are structured with education, skills building, and support. Participants will receive and use a Spouse Workbook with information and activities.
131999|NCT01828593|B4|Baseline|Total|Total of all reporting groups
132000|NCT01828593|B3|Baseline|SBI 5.0g|"Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
132157|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
132001|NCT01828593|B2|Baseline|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
132002|NCT01828593|B1|Baseline|Placebo|Matching Placebo
132003|NCT01828593|P3|Participant Flow|SBI 5.0g|"Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
132004|NCT01828593|P2|Participant Flow|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
132005|NCT01828593|P1|Participant Flow|Placebo|"Matching Placebo~Following 4 weeks in placebo-controlled phase were randomized to either SBI 2.5 g or SBI 5.0 g"
132006|NCT01828593|O2|Outcome|CD8 + T Cell Counts|
132007|NCT01828593|O1|Outcome|CD4 + T Cell Counts|
132008|NCT01828593|O3|Outcome|SBI 5.0 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 5.0 grams~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
132009|NCT01828593|O2|Outcome|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 grams~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
132010|NCT01828593|O1|Outcome|Placebo|Matching Placebo
132011|NCT01828593|O3|Outcome|SBI 5.0 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 5.0 grams~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
132012|NCT01828593|O2|Outcome|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 grams~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
132013|NCT01828593|O1|Outcome|Placebo|Matching Placebo
132014|NCT01828593|O3|Outcome|SBI 5.0 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 5.0 grams~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
132015|NCT01828593|O2|Outcome|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 grams~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
132016|NCT01828593|O1|Outcome|Placebo|Matching Placebo
132017|NCT01828593|O3|Outcome|SBI 5.0 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 5.0 grams~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
132018|NCT01828593|O2|Outcome|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 grams~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
132019|NCT01828593|O1|Outcome|Placebo|Matching Placebo
132020|NCT01828593|O3|Outcome|SBI 5.0g|"Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
132021|NCT01828593|O2|Outcome|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
132022|NCT01828593|O1|Outcome|Placebo|Matching Placebo
132023|NCT01828593|E2|Reported Event|SBI 5.0g|"Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g - Subjects on 5.0 g in the placebo controlled phase and placebo free phase and subjects who went from placebo in the placebo controlled phase to 5.0 g in the placebo free phase~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
132024|NCT01828593|E1|Reported Event|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g - Subjects on 2.5 g in the placebo controlled phase and placebo free phase and subjects who went from placebo in the placebo controlled phase to 2.5 g in the placebo free phase~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
132025|NCT01828476|B3|Baseline|Total|Total of all reporting groups
132026|NCT01828476|B2|Baseline|ARM B - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily, ABT-263 150 mg po daily, Hydroxychloroquine 200 mg po BID daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily*, Hydroxychloroquine 400 mg po BID daily Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 325 mg po daily*, Hydroxychloroquine 400 mg po BID daily~* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3."
132027|NCT01828476|B1|Baseline|ARM A - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily and ABT-263 150 mg po daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily* Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 350 mg po daily*~* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3.~NOTE: The dose escalation for ABT-263 combined with abiraterone was completed first prior to dose escalation with ABT-263 combined with hydroxychloroquine and abiraterone. Following both dose escalation portions of the trial, patients will then, and only then, be assigned to Arm A or Arm B of the phase II portion of the trial on a rotating basis of every other patient."
132028|NCT01828476|P2|Participant Flow|ARM B - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily, ABT-263 150 mg po daily, Hydroxychloroquine 200 mg po BID daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily*, Hydroxychloroquine 400 mg po BID daily Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 325 mg po daily*, Hydroxychloroquine 400 mg po BID daily~* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3."
132029|NCT01828476|P1|Participant Flow|ARM A - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily and ABT-263 150 mg po daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily* Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 350 mg po daily*~* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3.~NOTE: The dose escalation for ABT-263 combined with abiraterone was completed first prior to dose escalation with ABT-263 combined with hydroxychloroquine and abiraterone. Following both dose escalation portions of the trial, patients will then, and only then, be assigned to Arm A or Arm B of the phase II portion of the trial on a rotating basis of every other patient."
132030|NCT01828476|O2|Outcome|ARM B|"Abiraterone with both ABT-263 and Hydroxychloroquine~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B~Hydroxychloroquine: ARM B"
132031|NCT01828476|O1|Outcome|ARM A|"Abiraterone with ABT-263~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B"
132032|NCT01828476|O2|Outcome|ARM B|"Abiraterone with both ABT-263 and Hydroxychloroquine~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B~Hydroxychloroquine: ARM B"
132033|NCT01828476|O1|Outcome|ARM A|"Abiraterone with ABT-263~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B"
132034|NCT01828476|O2|Outcome|ARM B|"Abiraterone with both ABT-263 and Hydroxychloroquine~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B~Hydroxychloroquine: ARM B"
132035|NCT01828476|O1|Outcome|ARM A|"Abiraterone with ABT-263~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B"
132036|NCT01828476|O2|Outcome|ARM B|"Abiraterone with both ABT-263 and Hydroxychloroquine~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B~Hydroxychloroquine: ARM B"
132037|NCT01828476|O1|Outcome|ARM A|"Abiraterone with ABT-263~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B"
132038|NCT01828476|O2|Outcome|ARM B|"Abiraterone with both ABT-263 and Hydroxychloroquine~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B~Hydroxychloroquine: ARM B"
132039|NCT01828476|O1|Outcome|ARM A|"Abiraterone with ABT-263~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B"
132040|NCT01828476|O2|Outcome|ARM B - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily, ABT-263 150 mg po daily, Hydroxychloroquine 200 mg po BID daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily*, Hydroxychloroquine 400 mg po BID daily Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 325 mg po daily*, Hydroxychloroquine 400 mg po BID daily~* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3."
132158|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
132041|NCT01828476|O1|Outcome|ARM A - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily and ABT-263 150 mg po daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily* Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 350 mg po daily*~* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3.~NOTE: The dose escalation for ABT-263 combined with abiraterone was completed first prior to dose escalation with ABT-263 combined with hydroxychloroquine and abiraterone. Following both dose escalation portions of the trial, patients will then, and only then, be assigned to Arm A or Arm B of the phase II portion of the trial on a rotating basis of every other patient."
132042|NCT01828476|O2|Outcome|ARM B|"Abiraterone with both ABT-263 and Hydroxychloroquine~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B~Hydroxychloroquine: ARM B"
132043|NCT01828476|O1|Outcome|ARM A|"Abiraterone with ABT-263~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B"
132044|NCT01828476|O2|Outcome|ARM B|"Abiraterone with both ABT-263 and Hydroxychloroquine~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B~Hydroxychloroquine: ARM B"
132045|NCT01828476|O1|Outcome|ARM A|"Abiraterone with ABT-263~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B"
132046|NCT01828476|E2|Reported Event|ARM B - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily, ABT-263 150 mg po daily, Hydroxychloroquine 200 mg po BID daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily*, Hydroxychloroquine 400 mg po BID daily Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 325 mg po daily*, Hydroxychloroquine 400 mg po BID daily~* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3."
132047|NCT01828476|E1|Reported Event|ARM A - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily and ABT-263 150 mg po daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily* Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 350 mg po daily*~* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3.~NOTE: The dose escalation for ABT-263 combined with abiraterone was completed first prior to dose escalation with ABT-263 combined with hydroxychloroquine and abiraterone. Following both dose escalation portions of the trial, patients will then, and only then, be assigned to Arm A or Arm B of the phase II portion of the trial on a rotating basis of every other patient."
132048|NCT01828281|B3|Baseline|Total|Total of all reporting groups
132049|NCT01828281|B2|Baseline|Control|subtherapeutic CPAP using 4 cm water
132050|NCT01828281|B1|Baseline|Therapeutic CPAP|The CPAP level for each patient in the arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
132051|NCT01828281|P2|Participant Flow|Control|subtherapeutic CPAP using 4 cm water
132052|NCT01828281|P1|Participant Flow|Therapeutic CPAP|The continuous positive airway pressure (CPAP) level for each patient in the arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
132053|NCT01828281|O2|Outcome|Control|subtherapeutic CPAP using 4 cm water
132054|NCT01828281|O1|Outcome|Therapeutic CPAP|The CPAP level for each patient in the arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
132055|NCT01828281|O2|Outcome|Control|subtherapeutic CPAP using 4 cm water
132056|NCT01828281|O1|Outcome|Therapeutic CPAP|The CPAP level for each patient in the arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
132057|NCT01828281|O2|Outcome|Control|"subtherapeutic CPAP using 4 cm water~CPAP: All subjects will undergo ultrasound examination of the abdomen the day after overnight PSG and then at 3 months after completion of therapeutic or subtherapeutic CPAP treatment of 4 cm water."
132058|NCT01828281|O1|Outcome|Therapeutic CPAP|The CPAP level for each patient in the arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
132059|NCT01828281|E2|Reported Event|Control|subtherapeutic CPAP using 4 cm water
132060|NCT01828281|E1|Reported Event|Therapeutic CPAP|The CPAP level for each patient in the therapeutic CPAP arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
132061|NCT01828216|B3|Baseline|Total|Total of all reporting groups
132062|NCT01828216|B2|Baseline|Ambulatory Sleep Study|home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events.
132063|NCT01828216|B1|Baseline|In-hospital Sleep Study|Conventional polysomnography will be performed as in-patient at Prince of Wales Hospital for every subject in this group, recording electroencephalogram, electro-oculogram, submental electromyogram, bilateral anterior tibial electromyogram, electrocardiogram, chest & abdominal wall movement by inductance plethysmography, airflow measured by a nasal pressure transducer & supplemented by oronasal airflow thermistor, & finger pulse oximetry.
132064|NCT01828216|P2|Participant Flow|Ambulatory Sleep Study|The home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events.
132101|NCT01827839|P1|Participant Flow|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
132102|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
132065|NCT01828216|P1|Participant Flow|In-hospital Sleep Study|Conventional polysomnography will be performed as in-patient at Prince of Wales Hospital for every subject in this group, recording electroencephalogram, electro-oculogram, submental electromyogram, bilateral anterior tibial electromyogram, electrocardiogram, chest & abdominal wall movement by inductance plethysmography, airflow measured by a nasal pressure transducer & supplemented by oronasal airflow thermistor, & finger pulse oximetry.
132066|NCT01828216|O2|Outcome|Ambulatory Sleep Study|Home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events.
132067|NCT01828216|O1|Outcome|In-hospital Sleep Study|Conventional polysomnography will be performed as in-patient at Prince of Wales Hospital for every subject in this group, recording electroencephalogram, electro-oculogram, submental electromyogram, bilateral anterior tibial electromyogram, electrocardiogram, chest & abdominal wall movement by inductance plethysmography, airflow measured by a nasal pressure transducer & supplemented by oronasal airflow thermistor, & finger pulse oximetry.
132068|NCT01828216|O2|Outcome|Ambulatory CPAP Titration|Following detection of apnea-hypopnea index (AHI) of 15 events per hour or more by home sleep study or polysomnography, patients received CPAP therapy for 3 months after an overnight autoCPAP titration at in-hospital or ambulatory home setting.
132069|NCT01828216|O1|Outcome|In-hospital CPAP Titration|Following detection of apnea-hypopnea index (AHI) of 15 events per hour or more by home sleep study or polysomnography, patients received CPAP therapy for 3 months after an overnight autoCPAP titration at in-hospital or ambulatory home setting.
132070|NCT01828216|E2|Reported Event|Ambulatory Sleep Study|home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events.
132071|NCT01828216|E1|Reported Event|In-hospital Sleep Study|Conventional polysomnography will be performed as in-patient at Prince of Wales Hospital for every subject in this group, recording electroencephalogram, electro-oculogram, submental electromyogram, bilateral anterior tibial electromyogram, electrocardiogram, chest & abdominal wall movement by inductance plethysmography, airflow measured by a nasal pressure transducer & supplemented by oronasal airflow thermistor, & finger pulse oximetry.
132072|NCT01828164|B1|Baseline|All Study Participants|As per split mouth design, one side of the mouth received treatment while the other side of the mouth served as the control. In this design, each subject was both treated and served as control.
132073|NCT01828164|P1|Participant Flow|All Study Participants|As per split mouth design, one side of the mouth received treatment while the other side of the mouth served as the control. In this design, each subject was both treated and served as control.
132074|NCT01828164|O2|Outcome|Control Arm|The side of the mouth that was the control. As per split mouth design, one side of the mouth received treatment while the other side of the mouth served as the control. In this design, each subject was both treated and served as control.
132075|NCT01828164|O1|Outcome|Treatment Arm|The side of the mouth that received treatment. As per split mouth design, one side of the mouth received treatment while the other side of the mouth served as the control. In this design, each subject was both treated and served as control.
132076|NCT01828164|O2|Outcome|Control Arm|The side of the mouth that was the control. As per split mouth design, one side received treatment while the other side served as the control. In this design, each subject was both treated and served as control.
132077|NCT01828164|O1|Outcome|Treatment Arm|The side of the mouth that received treatment. As per split mouth design, one side received treatment while the other side served as the control. In this design, each subject was both treated and served as control.
132078|NCT01828164|O2|Outcome|Control Arm|The side of the mouth that was the control. As per split mouth design, one side received treatment while the other side served as the control. In this design, each subject was both treated and served as control.
132079|NCT01828164|O1|Outcome|Treatment Arm|The side of the mouth that received treatment. As per split mouth design, one side received treatment while the other side served as the control. In this design, each subject was both treated and served as control.
132080|NCT01828164|E2|Reported Event|Control Arm|The side of the mouth that was the control. As per split mouth design, one side received treatment while the other side served as the control. In this design, each subject was both treated and served as control.
132081|NCT01828164|E1|Reported Event|Treatment Arm|The side of the mouth that received treatment. As per split mouth design, one side received treatment while the other side served as the control. In this design, each subject was both treated and served as control.
132082|NCT01828112|B3|Baseline|Total|Total of all reporting groups
132083|NCT01828112|B2|Baseline|Chemotherapy|Chemotherapy as determined by BIRC.
132084|NCT01828112|B1|Baseline|Ceritinib|Ceritinib 750 mg
132085|NCT01828112|P2|Participant Flow|Chemotherapy|Chemotherapy as determined by BIRC.
132086|NCT01828112|P1|Participant Flow|Ceritinib|Ceritinib 750 mg
132087|NCT01828112|O2|Outcome|Chemotherapy|Chemotherapy as determined by BIRC.
132088|NCT01828112|O1|Outcome|Ceritinib|Ceritinib 750 mg
132089|NCT01828112|E2|Reported Event|Chemotherapy|Chemotherapy as determined by BIRC.
132090|NCT01828112|E1|Reported Event|Ceritinib|Ceritinib 750 mg
132091|NCT01828099|B3|Baseline|Total|Total of all reporting groups
132092|NCT01828099|B2|Baseline|Chemotherapy|Chemotherapy patients (Induction per Investigator’s choice)
132093|NCT01828099|B1|Baseline|Ceritinib|Ceritinib 750 mg
132094|NCT01828099|P2|Participant Flow|Chemotherapy|Chemotherapy patients (Induction per Investigator’s choice)
132095|NCT01828099|P1|Participant Flow|Ceritinib|Ceritinib 750 mg
132096|NCT01828099|O2|Outcome|Chemotherapy|Chemotherapy patients (Induction per Investigator’s choice)
132097|NCT01828099|O1|Outcome|Ceritinib|Ceritinib 750 mg
132098|NCT01828099|E2|Reported Event|Chemotherapy|Chemotherapy patients (Induction per Investigator’s choice)
132099|NCT01828099|E1|Reported Event|Ceritinib|Ceritinib 750 mg
157766|NCT01717989|O3|Outcome|Q2 2011|Second quarter (Q2), 2011
132103|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
132104|NCT01827839|O3|Outcome|GSK1437173A Group >=70 YOA|Subgroup of subjects of or above 70 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
132105|NCT01827839|O2|Outcome|GSK1437173A Group 60-69 YOA|Subgroup of subjects between 60 and 69 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
132106|NCT01827839|O1|Outcome|GSK1437173A Group 50-59 YOA|Subgroup of subjects between 50 and 59 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
132107|NCT01827839|O3|Outcome|GSK1437173A Group >=70 YOA|Subgroup of subjects of or above 70 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
132108|NCT01827839|O2|Outcome|GSK1437173A Group 60-69 YOA|Subgroup of subjects between 60 and 69 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
132109|NCT01827839|O1|Outcome|GSK1437173A Group 50-59 YOA|Subgroup of subjects between 50 and 59 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
132110|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
132111|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
132112|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
132113|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
132114|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
132115|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
132116|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
132117|NCT01827839|O4|Outcome|GSK1437173A Group >=70 YOA|Subgroup of subjects of or above 70 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
132118|NCT01827839|O3|Outcome|GSK1437173A Group 60-69 YOA|Subgroup of subjects between 60 and 69 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
132119|NCT01827839|O2|Outcome|GSK1437173A Group 50-59 YOA|Subgroup of subjects between 50 and 59 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
132120|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
132121|NCT01827839|E1|Reported Event|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
132122|NCT01827670|B3|Baseline|Total|Total of all reporting groups
132123|NCT01827670|B2|Baseline|Test Dentifrice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
132124|NCT01827670|B1|Baseline|Control Dentifrice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
132125|NCT01827670|P2|Participant Flow|Test Dentifrice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds
132126|NCT01827670|P1|Participant Flow|Control Dentifrice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds .
132127|NCT01827670|O2|Outcome|Test Dentrifice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454% w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds
132128|NCT01827670|O1|Outcome|Control Dentrifice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
132156|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
132129|NCT01827670|O2|Outcome|Test Dentrifice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454% w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
132130|NCT01827670|O1|Outcome|Control Dentrifice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
132131|NCT01827670|O2|Outcome|Test Dentrifice (0.454% Stannous Fluoride Dentifrice)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454% w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds
132132|NCT01827670|O1|Outcome|Control Dentrifice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 mililiter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds
132133|NCT01827670|O2|Outcome|Test Dentrifice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
132134|NCT01827670|O1|Outcome|Control Dentrifice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
132135|NCT01827670|O2|Outcome|Test Dentrifice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds
132136|NCT01827670|O1|Outcome|Control Dentrifice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
132137|NCT01827670|O2|Outcome|Test Dentrifice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
132138|NCT01827670|O1|Outcome|Control Dentrifice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
132139|NCT01827670|E2|Reported Event|Test Dentifrice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
132140|NCT01827670|E1|Reported Event|Control Dentifrice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds
132141|NCT01827592|B4|Baseline|Total|Total of all reporting groups
132142|NCT01827592|B3|Baseline|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
132143|NCT01827592|B2|Baseline|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
132144|NCT01827592|B1|Baseline|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
132145|NCT01827592|P3|Participant Flow|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
132146|NCT01827592|P2|Participant Flow|EBX 5|Elobixibat 5 mg/day as administered orally in a tablet form starting from Baseline visit till EoT visit.
132147|NCT01827592|P1|Participant Flow|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till End of the Treatment (EoT) visit.
132148|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
132149|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
132150|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
132151|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
132152|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
132153|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
132154|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
132155|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
132159|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
132160|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
132161|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
132162|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
132163|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
132164|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
132165|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
132166|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
132167|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
132168|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
132169|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
132170|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
132171|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
132172|NCT01827592|E3|Reported Event|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
132173|NCT01827592|E2|Reported Event|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
132174|NCT01827592|E1|Reported Event|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
132175|NCT01827475|B4|Baseline|Total|Total of all reporting groups
132176|NCT01827475|B3|Baseline|Ibuprofen-acetaminophen Combination|Ibuprofen 800 mg plus acetaminophen 1 gm
132177|NCT01827475|B2|Baseline|Acetaminophen|Acetaminophen 1 gm
132178|NCT01827475|B1|Baseline|Ibuprofen|Ibuprofen 800 mg
132179|NCT01827475|P3|Participant Flow|Ibuprofen-acetaminophen Combination|Ibuprofen 800 mg plus acetaminophen 1 gm
132180|NCT01827475|P2|Participant Flow|Acetaminophen|Acetaminophen 1 gm
132181|NCT01827475|P1|Participant Flow|Ibuprofen|Ibuprofen 800 mg
132182|NCT01827475|O3|Outcome|Ibuprofen-acetaminophen Combination|Ibuprofen 800 mg plus acetaminophen 1 gm
132183|NCT01827475|O2|Outcome|Acetaminophen|Acetaminophen 1 gm
132184|NCT01827475|O1|Outcome|Ibuprofen|Ibuprofen 800 mg
132185|NCT01827475|O3|Outcome|Ibuprofen-acetaminophen Combination|Ibuprofen 800 mg plus acetaminophen 1 gm
132186|NCT01827475|O2|Outcome|Acetaminophen|Acetaminophen 1 gm
132187|NCT01827475|O1|Outcome|Ibuprofen|Ibuprofen 800 mg
132188|NCT01827475|E3|Reported Event|Ibuprofen-acetaminophen Combination|Ibuprofen 800 mg plus acetaminophen 1 gm
132189|NCT01827475|E2|Reported Event|Acetaminophen|Acetaminophen 1 gm
132190|NCT01827475|E1|Reported Event|Ibuprofen|Ibuprofen 800 mg
132191|NCT01827462|B4|Baseline|Total|Total of all reporting groups
132192|NCT01827462|B3|Baseline|80-100 Years Old at Enrollment|"Participants receive the licensed annual vaccine, Fluzone® or High Dose Fluzone®~This vaccine is given intramuscularly"
132193|NCT01827462|B2|Baseline|60-79 Years Old at Enrollment|"Participants receive the licensed annual vaccine, Fluzone®~This vaccine is given intramuscularly"
132194|NCT01827462|B1|Baseline|18-30 Years Old at Enrollment|"Participants receive the licensed annual, Fluzone®~This vaccine is given intramuscularly"
132195|NCT01827462|P3|Participant Flow|80-100 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone®~This vaccine is given intramuscularly"
132196|NCT01827462|P2|Participant Flow|60-79 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone®~This vaccine is given intramuscularly"
132197|NCT01827462|P1|Participant Flow|18-30 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone®~This vaccine is given intramuscularly"
132198|NCT01827462|O3|Outcome|80-100 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season. For the following seasons, they received Fluzone High-Dose.~This vaccine is given intramuscularly"
132199|NCT01827462|O2|Outcome|60-79 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season. For the following seasons, they received Fluzone High-Dose.~This vaccine is given intramuscularly"
132200|NCT01827462|O1|Outcome|18-30 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone® through 2013-2014 then received licensed annual quadrivalent Fluzone.~This vaccine is given intramuscularly"
132201|NCT01827462|O3|Outcome|80-100 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone®~This vaccine is given intramuscularly"
132202|NCT01827462|O2|Outcome|60-79 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone®~This vaccine is given intramuscularly"
132203|NCT01827462|O1|Outcome|18-30 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone®~This vaccine is given intramuscularly"
132204|NCT01827462|E3|Reported Event|80-100 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season then they received licensed High-Dose trivalent inactivated vaccine, Fluzone High-Dose, starting with the 2014-2015 season.~This vaccine is given intramuscularly"
132205|NCT01827462|E2|Reported Event|60-79 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season then they received licensed High-Dose trivalent inactivated vaccine, Fluzone High-Dose, starting with the 2014-2015 season.~This vaccine is given intramuscularly"
132281|NCT01827332|E1|Reported Event|Oxytocin|"intranasal administration~Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET."
157767|NCT01717989|O2|Outcome|Q1 2011|First quarter (Q1), 2011
132206|NCT01827462|E1|Reported Event|18-30 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season then they received licensed quadrivalent vaccine, Fluzone starting with the 2014-2015 season.~This vaccine is given intramuscularly"
132207|NCT01827371|B5|Baseline|Total|Total of all reporting groups
132208|NCT01827371|B4|Baseline|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
132209|NCT01827371|B3|Baseline|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
132210|NCT01827371|B2|Baseline|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
132211|NCT01827371|B1|Baseline|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
132212|NCT01827371|P4|Participant Flow|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
132213|NCT01827371|P3|Participant Flow|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
132214|NCT01827371|P2|Participant Flow|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
132215|NCT01827371|P1|Participant Flow|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
132216|NCT01827371|O4|Outcome|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
132217|NCT01827371|O3|Outcome|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
132218|NCT01827371|O2|Outcome|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
132219|NCT01827371|O1|Outcome|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
132220|NCT01827371|O4|Outcome|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
132221|NCT01827371|O3|Outcome|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
132222|NCT01827371|O2|Outcome|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
132223|NCT01827371|O1|Outcome|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
132224|NCT01827371|O4|Outcome|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
132225|NCT01827371|O3|Outcome|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
132226|NCT01827371|O2|Outcome|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
132227|NCT01827371|O1|Outcome|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
132228|NCT01827371|O4|Outcome|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
132229|NCT01827371|O3|Outcome|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
132230|NCT01827371|O2|Outcome|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
132231|NCT01827371|O1|Outcome|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
132232|NCT01827371|E4|Reported Event|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
132233|NCT01827371|E3|Reported Event|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
132234|NCT01827371|E2|Reported Event|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
132235|NCT01827371|E1|Reported Event|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
132236|NCT01827358|B3|Baseline|Total|Total of all reporting groups
132237|NCT01827358|B2|Baseline|No Mupirocin (Control)|Participants received no treatment or placebo
132238|NCT01827358|B1|Baseline|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses
132239|NCT01827358|P2|Participant Flow|No Mupirocin (Control)|Participants received no treatment or placebo
132240|NCT01827358|P1|Participant Flow|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses
132241|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
132242|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
132243|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
132244|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
132245|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
132282|NCT01827319|B1|Baseline|Received TMR and Enrolled in ANGINA RELIEF Registry|
132246|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
132247|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
132248|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
132249|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
132250|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
132251|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
132252|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
132253|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
132254|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
132255|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
132256|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
132257|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
132258|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
132259|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
132260|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
132261|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
132262|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
132263|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
132264|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
132265|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
132266|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
132267|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
132268|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
132269|NCT01827358|E2|Reported Event|No Mupirocin (Control)|Participants received no treatment and no placebo.
132270|NCT01827358|E1|Reported Event|Mupirocin (Treatment)|Participants receive a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses
132271|NCT01827332|B3|Baseline|Total|Total of all reporting groups
132272|NCT01827332|B2|Baseline|Saline|"intranasal administration~Saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo prior to two individual sessions of MET."
132273|NCT01827332|B1|Baseline|Oxytocin|"intranasal administration~Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo prior to two individual sessions of MET."
132274|NCT01827332|P2|Participant Flow|Saline|"intranasal administration~Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET."
132275|NCT01827332|P1|Participant Flow|Oxytocin|"intranasal administration~Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET."
132276|NCT01827332|O2|Outcome|Saline|"intranasal administration~Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET."
132277|NCT01827332|O1|Outcome|Oxytocin|"intranasal administration~Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET."
132278|NCT01827332|O2|Outcome|Saline|"intranasal administration~Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET."
132279|NCT01827332|O1|Outcome|Oxytocin|"intranasal administration~Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET."
132280|NCT01827332|E2|Reported Event|Saline|"intranasal administration~Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET."
132287|NCT01827319|E1|Reported Event|Received TMR and Enrolled in ANGINA RELIEF Registry|
132288|NCT01827306|B3|Baseline|Total|Total of all reporting groups
132289|NCT01827306|B2|Baseline|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
132290|NCT01827306|B1|Baseline|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.~Biofreeze"
132291|NCT01827306|P2|Participant Flow|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
132292|NCT01827306|P1|Participant Flow|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.~Biofreeze"
132293|NCT01827306|O2|Outcome|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
132294|NCT01827306|O1|Outcome|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.~Biofreeze"
132295|NCT01827306|O2|Outcome|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
132296|NCT01827306|O1|Outcome|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.~Biofreeze"
132297|NCT01827306|O2|Outcome|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
132298|NCT01827306|O1|Outcome|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.~Biofreeze"
132299|NCT01827306|O2|Outcome|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
132300|NCT01827306|O1|Outcome|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.~Biofreeze"
132301|NCT01827306|E2|Reported Event|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
132302|NCT01827306|E1|Reported Event|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.~Biofreeze"
132303|NCT01827267|B3|Baseline|Total|Total of all reporting groups
132304|NCT01827267|B2|Baseline|Neratinib+Temsirolimus|Neratinib 240 mg + Temsirolimus 15 mg.
132305|NCT01827267|B1|Baseline|Neratinib|Neratinib 240 mg
132306|NCT01827267|P2|Participant Flow|Neratinib+Temsirolimus|Neratinib 240 mg + Temsirolimus 15 mg.
132307|NCT01827267|P1|Participant Flow|Neratinib|Neratinib 240 mg
132308|NCT01827267|O2|Outcome|Neratinib+Temsirolimus|Neratinib 240 mg + Temsirolimus 15 mg.
132309|NCT01827267|O1|Outcome|Neratinib|Neratinib 240 mg
132310|NCT01827267|O2|Outcome|Neratinib+Temsirolimus|Neratinib 240 mg + Temsirolimus 15 mg.
132311|NCT01827267|O1|Outcome|Neratinib|Neratinib 240 mg
132312|NCT01827267|O2|Outcome|Neratinib+Temsirolimus|Neratinib 240 mg + Temsirolimus 15 mg.
132313|NCT01827267|O1|Outcome|Neratinib|Neratinib 240 mg
132314|NCT01827267|O2|Outcome|Neratinib+Temsirolimus|Neratinib 240 mg + Temsirolimus 15 mg.
132315|NCT01827267|O1|Outcome|Neratinib|Neratinib 240 mg
132316|NCT01827267|O2|Outcome|Neratinib+Temsirolimus|Neratinib 240 mg + Temsirolimus 15 mg.
132317|NCT01827267|O1|Outcome|Neratinib|Neratinib 240 mg
132318|NCT01827267|E3|Reported Event|Ner+Tem Post Crossover|Neratinib 240 mg + Temsirolimus 15 mg for subjects who crossed over from Neratinb 240 mg arm
132319|NCT01827267|E2|Reported Event|Neratinib+Temsirolimus|Neratinib 240 mg + Temsirolimus 15 mg.
132320|NCT01827267|E1|Reported Event|Neratinib|Neratinib 240 mg
132321|NCT01827254|B1|Baseline|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon, bevacizumab without interferon, sorafenib, axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-interventional study.
132322|NCT01827254|P1|Participant Flow|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon, bevacizumab without interferon, sorafenib, axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-interventional study.
132323|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first­line sunitinib, followed by third line treatment with bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib, temsirolimus or everolimus as per standard local practice.
132324|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first­line sunitinib, followed by second line treatment with bevacizumab (with interferon),bevacizumab (without interferon), sorafenib, axitinib, temsirolimus or everolimus as per standard local practice.
132325|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first­line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon,bevacizumab without interferon, sorafenib,axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non­interventional study.
132326|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first­line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon,bevacizumab without interferon, sorafenib,axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non­-interventional study.
132353|NCT01826981|P9|Participant Flow|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and Child Pugh-Turcotte (CPT) B cirrhosis
132327|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first­line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon,bevacizumab without interferon, sorafenib,axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non­-interventional study.
132328|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first­line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon,bevacizumab without interferon, sorafenib,axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-­interventional study.
132329|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with metastatic renal cell carcinoma (MRCC) who met the selection criteria and received sunitinib as first-line therapy as per standard local practice.
132330|NCT01827254|E1|Reported Event|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon, bevacizumab without interferon, sorafenib, axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-interventional study.
132331|NCT01826981|B16|Baseline|Total|Total of all reporting groups
132332|NCT01826981|B15|Baseline|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
132333|NCT01826981|B14|Baseline|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
132334|NCT01826981|B13|Baseline|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132335|NCT01826981|B12|Baseline|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132336|NCT01826981|B11|Baseline|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132337|NCT01826981|B10|Baseline|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132338|NCT01826981|B9|Baseline|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
132339|NCT01826981|B8|Baseline|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
132340|NCT01826981|B7|Baseline|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
132341|NCT01826981|B6|Baseline|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
132342|NCT01826981|B5|Baseline|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
132343|NCT01826981|B4|Baseline|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
132344|NCT01826981|B3|Baseline|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
132345|NCT01826981|B2|Baseline|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
132346|NCT01826981|B1|Baseline|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
132347|NCT01826981|P15|Participant Flow|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
132348|NCT01826981|P14|Participant Flow|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
132349|NCT01826981|P13|Participant Flow|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132350|NCT01826981|P12|Participant Flow|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132351|NCT01826981|P11|Participant Flow|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132352|NCT01826981|P10|Participant Flow|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|Sofosbuvir (SOF) 400 mg once daily+Velpatasvir (VEL) 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132354|NCT01826981|P8|Participant Flow|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
132355|NCT01826981|P7|Participant Flow|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
132356|NCT01826981|P6|Participant Flow|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
132357|NCT01826981|P5|Participant Flow|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
132358|NCT01826981|P4|Participant Flow|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
132359|NCT01826981|P3|Participant Flow|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
132360|NCT01826981|P2|Participant Flow|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
132361|NCT01826981|P1|Participant Flow|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
132362|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
132363|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
132364|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132365|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132366|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132367|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132368|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
132369|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
132370|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
132371|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
132372|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
132373|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
132374|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
132375|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
132376|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
132377|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
132378|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
132379|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132380|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132779|NCT01824602|P1|Participant Flow|Group 4: Placebo|"Placebo pills~Placebo : Placebo sugar pills"
132381|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132382|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132383|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
132384|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
132385|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
132386|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
132387|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
132388|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
132389|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
132390|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
132391|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
132392|NCT01826981|O1|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
132393|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
132394|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
132395|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132396|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132397|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132398|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132399|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
132400|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
132401|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
132402|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
132403|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
132404|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
132405|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
132406|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
132407|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
132408|NCT01826981|O1|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
132409|NCT01826981|O11|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
132410|NCT01826981|O10|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
132411|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
132412|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
132413|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
132414|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
132415|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
132416|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
132417|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
132418|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
132419|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
132420|NCT01826981|O11|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
132421|NCT01826981|O10|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
132422|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
132423|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
132424|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
132425|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
132426|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
132427|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
132428|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
132429|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
132430|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
132431|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
132432|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
132433|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132434|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132435|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132648|NCT01826201|O1|Outcome|0% and 10% MOL4239 Ointment|10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
132436|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132437|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
132438|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
132439|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
132440|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
132441|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
132442|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
132443|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
132444|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
132445|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
132446|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
132447|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
132448|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132449|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132450|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132451|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132452|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
132453|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
132454|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
132455|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
132456|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
132457|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
132458|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
132459|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
132460|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
132461|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
132462|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
132463|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132464|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132465|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132466|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132467|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
132468|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
132469|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
132470|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
132471|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
132472|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
132473|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
132474|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
132475|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
132476|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
132477|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
132478|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132479|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132480|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132481|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132482|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
132483|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
132484|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
132485|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
132486|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
132487|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
132488|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
132489|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
132490|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
132491|NCT01826981|E15|Reported Event|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132492|NCT01826981|E14|Reported Event|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132493|NCT01826981|E13|Reported Event|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132494|NCT01826981|E12|Reported Event|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
132495|NCT01826981|E11|Reported Event|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
132496|NCT01826981|E10|Reported Event|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
132497|NCT01826981|E9|Reported Event|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
132498|NCT01826981|E8|Reported Event|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
132499|NCT01826981|E7|Reported Event|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
132500|NCT01826981|E6|Reported Event|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
132501|NCT01826981|E5|Reported Event|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
132502|NCT01826981|E4|Reported Event|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
132503|NCT01826981|E3|Reported Event|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
132504|NCT01826981|E2|Reported Event|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
132505|NCT01826981|E1|Reported Event|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
132506|NCT01826812|B3|Baseline|Total|Total of all reporting groups
132507|NCT01826812|B2|Baseline|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
132508|NCT01826812|B1|Baseline|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
132509|NCT01826812|P2|Participant Flow|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
132510|NCT01826812|P1|Participant Flow|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
132511|NCT01826812|O2|Outcome|Controls|Participants without dry eye.
132512|NCT01826812|O1|Outcome|Dry Eye|Patients with Sjogren Syndrome related or non-Sjogren Syndrome related dry eye.
132513|NCT01826812|O2|Outcome|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
132514|NCT01826812|O1|Outcome|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
132515|NCT01826812|O2|Outcome|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
132516|NCT01826812|O1|Outcome|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
132517|NCT01826812|O2|Outcome|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
132518|NCT01826812|O1|Outcome|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
132519|NCT01826812|O2|Outcome|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
132520|NCT01826812|O1|Outcome|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
132521|NCT01826812|E2|Reported Event|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
132522|NCT01826812|E1|Reported Event|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
132523|NCT01826604|B3|Baseline|Total|Total of all reporting groups
132524|NCT01826604|B2|Baseline|Control|Other retractor used during C-section
132525|NCT01826604|B1|Baseline|Alexis O C-section Retractor|Alexis O retractor used during C-section
132526|NCT01826604|P2|Participant Flow|Control|"Conventional hand-held surgical retractors used for C-sections will be used, including the bladder blade (Doyen retractor) and the Richardson retractor.~Control- Conventional hand-held retractors: Conventional hand-held retractors will be used. A self-retaining barrier retractor will not be used."
132527|NCT01826604|P1|Participant Flow|Alexis O C-section Retractor|"The Alexis O C-section retractor will be used. Other hand-held retractors will be used as deemed necessary by the surgeon.~Alexis O C-Section Retractor: The Alexis O C-section retractor will be used. Other hand-held retractors that are deemed necessary to the surgery by the physician will also be used."
132528|NCT01826604|O2|Outcome|Control|Outcomes at each time period are additive so that patients who experienced the outcome at each time point are included in the next time point. Patients may have experienced more than one type of outcome and are reported for each outcome experienced. The outcome of SSI or wound disruption includes cumulative of all patients who experienced either type of outcome.
132780|NCT01824602|O4|Outcome|ESL 1800 mg|(ITT Population
132529|NCT01826604|O1|Outcome|Alexis Retractor|Outcomes at each time period are additive so that patients who experienced the outcome at each time point are included in the next time point. Patients may have experienced more than one type of outcome and are reported for each outcome experienced. The outcome of SSI or wound disruption includes cumulative of all patients who experienced either type of outcome.
132530|NCT01826604|O2|Outcome|Control|Outcomes at each time period are additive so that patients who experienced the outcome at each time point are included in the next time point. Patients may have experienced more than one type of outcome and are reported for each outcome experienced. The outcome of SSI or wound disruption includes cumulative of all patients who experienced either type of outcome.
132531|NCT01826604|O1|Outcome|Alexis Retractor|Outcomes at each time period are additive so that patients who experienced the outcome at each time point are included in the next time point. Patients may have experienced more than one type of outcome and are reported for each outcome experienced. The outcome of SSI or wound disruption includes cumulative of all patients who experienced either type of outcome.
132532|NCT01826604|E2|Reported Event|Control|No adverse events
132533|NCT01826604|E1|Reported Event|Alexis Retractor|No adverse events
132534|NCT01826513|B4|Baseline|Total|Total of all reporting groups
132535|NCT01826513|B3|Baseline|Modified AutoSet Then Standard AutoSet|Participants first received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) for one night, and then received therapy with the standard AutoSet algorithm the following night
132536|NCT01826513|B2|Baseline|Standard AutoSet Algorithm|Participants first received therapy with the Standard AutoSet algorithm for one night, and then received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) the following night.
132537|NCT01826513|B1|Baseline|Unblinded Investigational Arm|Participants participated in an unblinded investigational phase of the trial prior to, and separate from, the single-blind cross-over phase of the trial. Data was collected from the his phase to aid the final development of the algorithm before proceeding to algorithm validation (ie. cross-over phase).
132538|NCT01826513|P3|Participant Flow|Modified AutoSet Then Standard AutoSet|Participants first received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) for one night, and then received therapy with the standard AutoSet algorithm the following night.
132539|NCT01826513|P2|Participant Flow|Standard AutoSet Algorithm|Participants first received therapy with the Standard AutoSet algorithm for one night, and then received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) the following night.
132540|NCT01826513|P1|Participant Flow|Unblinded Investigational Arm|Participants participated in an unblinded investigational phase of the trial prior to, and separate from, the single-blind cross-over phase of the trial. Data was collected from the his phase to aid the final development of the algorithm before proceeding to algorithm validation (ie. cross-over phase).
132541|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
132542|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
132543|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
132544|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
132545|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
132546|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
132547|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
132548|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
132549|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
132550|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
132551|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
132552|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
132553|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
132554|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
132555|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
132556|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
132557|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
132558|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
132559|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
132560|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
132561|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
132562|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
132563|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
132564|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
132781|NCT01824602|O3|Outcome|ESL 1200 mg|ITT Population
132565|NCT01826513|E3|Reported Event|Modified AutoSet Then Standard AutoSet|Participants first received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) for one night, and then received therapy with the standard AutoSet algorithm the following night.
132566|NCT01826513|E2|Reported Event|Standard AutoSet Algorithm|Participants first received therapy with the Standard AutoSet algorithm for one night, and then received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) the following night.
132567|NCT01826513|E1|Reported Event|Unblinded Investigational Arm|Participants participated in an unblinded investigational phase of the trial prior to, and separate from, the single-blind cross-over phase of the trial. Data was collected from the his phase to aid the final development of the algorithm before proceeding to algorithm validation (ie. cross-over phase).
132568|NCT01826422|B3|Baseline|Total|Total of all reporting groups
132569|NCT01826422|B2|Baseline|Sunflower Oil|Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
132570|NCT01826422|B1|Baseline|EPA and DHA|Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
132571|NCT01826422|P2|Participant Flow|Sunflower Oil|Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
132572|NCT01826422|P1|Participant Flow|EPA and DHA|Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
132573|NCT01826422|O2|Outcome|Sunflower Oil|Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
132574|NCT01826422|O1|Outcome|EPA and DHA|Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
132575|NCT01826422|O2|Outcome|Sunflower Oil|Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
132576|NCT01826422|O1|Outcome|EPA and DHA|Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
132577|NCT01826422|O2|Outcome|Sunflower Oil|Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
132578|NCT01826422|O1|Outcome|EPA and DHA|Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
132579|NCT01826422|O2|Outcome|Sunflower Oil|Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
132580|NCT01826422|O1|Outcome|EPA and DHA|Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
132581|NCT01826422|O2|Outcome|Sunflower Oil|Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
132582|NCT01826422|O1|Outcome|EPA and DHA|Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
132583|NCT01826422|O2|Outcome|Sunflower Oil|Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
132584|NCT01826422|O1|Outcome|EPA and DHA|Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
132585|NCT01826422|O2|Outcome|Sunflower Oil|Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
132782|NCT01824602|O2|Outcome|ESL 600 mg|ITT Population
132586|NCT01826422|O1|Outcome|EPA and DHA|Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
132587|NCT01826422|O2|Outcome|Sunflower Oil|Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
132588|NCT01826422|O1|Outcome|EPA and DHA|Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
132589|NCT01826422|O2|Outcome|Sunflower Oil|Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
132590|NCT01826422|O1|Outcome|EPA and DHA|Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
132591|NCT01826422|O2|Outcome|Sunflower Oil|Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
132592|NCT01826422|O1|Outcome|EPA and DHA|Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
132593|NCT01826422|O2|Outcome|Sunflower Oil|Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
132594|NCT01826422|O1|Outcome|EPA and DHA|Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
132595|NCT01826422|O2|Outcome|Sunflower Oil|Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
132596|NCT01826422|O1|Outcome|EPA and DHA|Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
132597|NCT01826422|O2|Outcome|Sunflower Oil|Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
132598|NCT01826422|O1|Outcome|EPA and DHA|Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
132599|NCT01826422|O2|Outcome|Sunflower Oil|Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
132600|NCT01826422|O1|Outcome|EPA and DHA|Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
132601|NCT01826422|O2|Outcome|Sunflower Oil|Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
132602|NCT01826422|O1|Outcome|EPA and DHA|Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
132603|NCT01826422|O2|Outcome|Sunflower Oil|Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
132604|NCT01826422|O1|Outcome|EPA and DHA|Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
132605|NCT01826422|O2|Outcome|Sunflower Oil|Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
132649|NCT01826201|O2|Outcome|Placebo Ointment|10% MOL4239 to one target lesion and placebo to contralateral target lesion
132783|NCT01824602|O1|Outcome|Placebo|ITT Population
132606|NCT01826422|O1|Outcome|EPA and DHA|Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
132607|NCT01826422|O2|Outcome|Sunflower Oil|Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
132608|NCT01826422|O1|Outcome|EPA and DHA|Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
132609|NCT01826422|O2|Outcome|Sunflower Oil|Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
132610|NCT01826422|O1|Outcome|EPA and DHA|Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
132611|NCT01826422|O2|Outcome|Sunflower Oil|Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
132612|NCT01826422|O1|Outcome|EPA and DHA|Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
132613|NCT01826422|E2|Reported Event|Sunflower Oil|"Supplementation of placebo with sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The capsules sizes are specially for children to improved the feeding process. This placebo is sunflower oil and so will not expected to produce anti-inflammatory or insulin sensitivity effects.~Placebo Comparator: Sunflower oil; the placebo capsules will also contain sunflower oil. Each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg."
132614|NCT01826422|E1|Reported Event|EPA and DHA|"Supplementation of 2.9 g / d of EPA and DHA will be provided in 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The capsules sizes are specially for children to improved the feeding process and its presentation is in gelatin capsules. The supplement is purified fish oil with pharmaceutical grade.~EPA and DHA: Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U."
132615|NCT01826370|B1|Baseline|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
132616|NCT01826370|P1|Participant Flow|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
132617|NCT01826370|O1|Outcome|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
132618|NCT01826370|O1|Outcome|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
132619|NCT01826370|O1|Outcome|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
132620|NCT01826370|E1|Reported Event|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
132621|NCT01826227|B1|Baseline|Positron Emission Tomography|"This is a pilot study to determine the ability of intraoperative PET probe to detect and localize recurrent disease. Patients with evidence for a first recurrence of ovarian, fallopian tube or primary peritoneal carcinoma, with evidence of 18F-FDG avid disease on 18F-FDG PET/CT and who are able to undergo secondary CRS are eligible. 20 patients will be studied. All patients will undergo secondary cytoreduction guided by intraoperative PET probe survey. Intraoperative count levels as well as exvivo counts of the resected specimens will be done. Specimens detected with probe only will be labeled so and will be submitted to pathology for histopathologic confirmation.~Positron Emission Tomography~18F-Fluoro-2-deoxy-D-lucose~Cytoreductive surgery"
132622|NCT01826227|P1|Participant Flow|Positron Emission Tomography|"This is a pilot study to determine the ability of intraoperative PET probe to detect and localize recurrent disease. Patients with evidence for a first recurrence of ovarian, fallopian tube or primary peritoneal carcinoma, with evidence of 18F-FDG avid disease on 18F-FDG PET/CT and who are able to undergo secondary CRS are eligible. 20 patients will be studied. All patients will undergo secondary cytoreduction guided by intraoperative PET probe survey. Intraoperative count levels as well as exvivo counts of the resected specimens will be done. Specimens detected with probe only will be labeled so and will be submitted to pathology for histopathologic confirmation.~Positron Emission Tomography~18F-Fluoro-2-deoxy-D-lucose~Cytoreductive surgery"
132623|NCT01826227|O1|Outcome|Positron Emission Tomography|"This is a pilot study to determine the ability of intraoperative PET probe to detect and localize recurrent disease. Patients with evidence for a first recurrence of ovarian, fallopian tube or primary peritoneal carcinoma, with evidence of 18F-FDG avid disease on 18F-FDG PET/CT and who are able to undergo secondary CRS are eligible. 20 patients will be studied. All patients will undergo secondary cytoreduction guided by intraoperative PET probe survey. Intraoperative count levels as well as exvivo counts of the resected specimens will be done. Specimens detected with probe only will be labeled so and will be submitted to pathology for histopathologic confirmation.~Positron Emission Tomography~18F-Fluoro-2-deoxy-D-lucose~Cytoreductive surgery"
132650|NCT01826201|O1|Outcome|10% MOL4239 Ointment|10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
132651|NCT01826201|E1|Reported Event|0% and 10% MOL4239 Ointment|10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
132652|NCT01825837|B5|Baseline|Total|Total of all reporting groups
132653|NCT01825837|B4|Baseline|ESL (Part I - Not Randomised Patients)|This group corresponds to the 17 patients who did not complete part I and therefore where not randomised to any traeatment group.
132624|NCT01826227|E1|Reported Event|Positron Emission Tomography|"This is a pilot study to determine the ability of intraoperative PET probe to detect and localize recurrent disease. Patients with evidence for a first recurrence of ovarian, fallopian tube or primary peritoneal carcinoma, with evidence of 18F-FDG avid disease on 18F-FDG PET/CT and who are able to undergo secondary CRS are eligible. 20 patients will be studied. All patients will undergo secondary cytoreduction guided by intraoperative PET probe survey. Intraoperative count levels as well as exvivo counts of the resected specimens will be done. Specimens detected with probe only will be labeled so and will be submitted to pathology for histopathologic confirmation.~Positron Emission Tomography~18F-Fluoro-2-deoxy-D-lucose~Cytoreductive surgery"
132625|NCT01826214|B3|Baseline|Total|Total of all reporting groups
132626|NCT01826214|B2|Baseline|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
132627|NCT01826214|B1|Baseline|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
132628|NCT01826214|P2|Participant Flow|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
132629|NCT01826214|P1|Participant Flow|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
132630|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
132631|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
132632|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
132633|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
132634|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
132635|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
132636|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
132637|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
132638|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
132639|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
132640|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
132641|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
132642|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
132643|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
132644|NCT01826214|E2|Reported Event|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
132645|NCT01826214|E1|Reported Event|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
132646|NCT01826201|B1|Baseline|10% MOL4239 Ointment & Placebo Ointment|10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
132647|NCT01826201|P1|Participant Flow|0% and 10% MOL4239 Ointment|10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
132784|NCT01824602|E4|Reported Event|ESL 1800 mg|Safety Population
132654|NCT01825837|B3|Baseline|Group 1 [(Part II) 1800 mg]|BIA 2-093 1800 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
132655|NCT01825837|B2|Baseline|Group 2 [(Part II) 900 mg]|BIA 2-093 900 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
132656|NCT01825837|B1|Baseline|Group 3 [(Part II) 300 mg]|BIA 2-093 300 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
132657|NCT01825837|P4|Participant Flow|ESL (Part I)|In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks. The participants that completed part I were randomised in Part II.
132658|NCT01825837|P3|Participant Flow|Group 1 [(Part II) 1800 mg]|BIA 2-093 1800 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
132659|NCT01825837|P2|Participant Flow|Group 2 [(Part II) 900 mg]|BIA 2-093 900 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
132660|NCT01825837|P1|Participant Flow|Group 3 [(Part II) 300 mg]|BIA 2-093 300 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
132661|NCT01825837|O3|Outcome|BIA 2-093 1800 mg|PART II - Intent-to-Treat Population
132662|NCT01825837|O2|Outcome|BIA 2-093 900 mg|PART II - Intent-to-Treat Population
132663|NCT01825837|O1|Outcome|BIA 2-093 300 mg|PART II - Intent-to-Treat Population
132664|NCT01825837|E3|Reported Event|Group 1 [(Part II) 1800 mg]|BIA 2-093 1800 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
132665|NCT01825837|E2|Reported Event|Group 2 [(Part II) 900 mg]|BIA 2-093 900 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
132666|NCT01825837|E1|Reported Event|Group 3 [(Part II) 300 mg]|BIA 2-093 300 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
132667|NCT01825798|B3|Baseline|Total|Total of all reporting groups
132668|NCT01825798|B2|Baseline|Metformin|Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
132669|NCT01825798|B1|Baseline|Placebo Hydrochloride Oral Solution|Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
132670|NCT01825798|P2|Participant Flow|Metformin|Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
132671|NCT01825798|P1|Participant Flow|Placebo Hydrochloride Oral Solution|Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
132672|NCT01825798|O2|Outcome|Metformin|Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
132673|NCT01825798|O1|Outcome|Placebo Hydrochloride Oral Solution|Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
132674|NCT01825798|O2|Outcome|Metformin|Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
132675|NCT01825798|O1|Outcome|Placebo Hydrochloride Oral Solution|Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
132676|NCT01825798|O2|Outcome|Metformin|Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
132677|NCT01825798|O1|Outcome|Placebo Hydrochloride Oral Solution|Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
132678|NCT01825798|O2|Outcome|Metformin|Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
132679|NCT01825798|O1|Outcome|Placebo Hydrochloride Oral Solution|Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
132680|NCT01825798|O2|Outcome|Metformin|Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
132681|NCT01825798|O1|Outcome|Placebo Hydrochloride Oral Solution|Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
132730|NCT01825200|O1|Outcome|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
132682|NCT01825798|O2|Outcome|Metformin|Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
132683|NCT01825798|O1|Outcome|Placebo Hydrochloride Oral Solution|Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
132684|NCT01825798|O2|Outcome|Metformin|Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
132685|NCT01825798|O1|Outcome|Placebo Hydrochloride Oral Solution|Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
132686|NCT01825798|O2|Outcome|Metformin|Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
132687|NCT01825798|O1|Outcome|Placebo Hydrochloride Oral Solution|Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
132688|NCT01825798|O2|Outcome|Metformin|Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
132689|NCT01825798|O1|Outcome|Placebo Hydrochloride Oral Solution|Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
132690|NCT01825798|O2|Outcome|Metformin|Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
132731|NCT01825200|O2|Outcome|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
132785|NCT01824602|E3|Reported Event|ESL 1200 mg|Safety Population
132691|NCT01825798|O1|Outcome|Placebo Hydrochloride Oral Solution|Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
132692|NCT01825798|O2|Outcome|Metformin|Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
132693|NCT01825798|O1|Outcome|Placebo Hydrochloride Oral Solution|Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
132694|NCT01825798|O2|Outcome|Metformin|Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
132695|NCT01825798|O1|Outcome|Placebo Hydrochloride Oral Solution|Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
132696|NCT01825798|E2|Reported Event|Metformin|Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
132697|NCT01825798|E1|Reported Event|Placebo Hydrochloride Oral Solution|Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
132698|NCT01825577|B1|Baseline|Single Arm|"Age 65yrs and above~Ability to ambulate (may use walking aid)~Male or Female~Clinical diagnosis of probable Alzheimer's Disease~AES score >40~Identified as fall risk by nursing staff"
132699|NCT01825577|P1|Participant Flow|Single Arm Transdermal Methylphenidate|"Age 65 yrs and above~Ability to ambulate (may use walking aid)~Male or Female~Clinical diagnosis of probable Alzheimer's Disease~AES score >40~Identified as fall risk by nursing staff"
132700|NCT01825577|O1|Outcome|Transdermal Methylphenidate|"2 Weeks of once daily 10mg Transdermal Methylphenidate followed by 2 weeks of once daily 15mg Transdermal Methylphenidate. Patch will be worn for approximately 7-10hrs each day.~Transdermal Methylphenidate: 2 Weeks of once daily 10mg Transdermal Methylphenidate followed by 2 weeks of once daily 15mg Transdermal Methylphenidate. Patch will be worn for approximately 7-10hrs each day."
132701|NCT01825577|O1|Outcome|Transdermal Methylphenidate|"2 Weeks of once daily 10mg Transdermal Methylphenidate followed by 2 weeks of once daily 15mg Transdermal Methylphenidate. Patch will be worn for approximately 7-10hrs each day.~Transdermal Methylphenidate: 2 Weeks of once daily 10mg Transdermal Methylphenidate followed by 2 weeks of once daily 15mg Transdermal Methylphenidate. Patch will be worn for approximately 7-10hrs each day."
132702|NCT01825577|E1|Reported Event|Single Arm Transdermal Methylphenidate|There were no adverse events reported.
132703|NCT01825408|B5|Baseline|Total|Total of all reporting groups
132776|NCT01824602|P4|Participant Flow|Group 1: Eslicarbazepine Acetate 1800 mg|"Eslicarbazepine acetate 1800 mg~Eslicarbazepine acetate 1800 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
132786|NCT01824602|E2|Reported Event|ESL 600 mg|Safety Population
132787|NCT01824602|E1|Reported Event|Placebo|Safety Population
132704|NCT01825408|B4|Baseline|Azithromycin, 6 Weeks|"Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration.~Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
132705|NCT01825408|B3|Baseline|Azithromycin, 3 Weeks|"Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration.~Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
132706|NCT01825408|B2|Baseline|Doxycycline, 6 Weeks|"Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 6 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.~Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
132707|NCT01825408|B1|Baseline|Doxycycline, 3 Weeks|"Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.~Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
132708|NCT01825408|P4|Participant Flow|Azithromycin, 6 Weeks|"Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration.~Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
132709|NCT01825408|P3|Participant Flow|Azithromycin, 3 Weeks|"Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration.~Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
132710|NCT01825408|P2|Participant Flow|Doxycycline, 6 Weeks|"Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 6 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.~Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
132711|NCT01825408|P1|Participant Flow|Doxycycline, 3 Weeks|"Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.~Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
132712|NCT01825408|O2|Outcome|Azithromycin, 6 Weeks|"Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration.~Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
132713|NCT01825408|O1|Outcome|Doxycycline, 6 Weeks|"Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 6 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.~Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
132714|NCT01825408|O2|Outcome|Azithromycin, 3 Weeks|"Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration.~Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
132777|NCT01824602|P3|Participant Flow|Group 2: Eslicarbazepine Acetate 1200 mg|"Eslicarbazepine acetate 1200 mg~Eslicarbazepine acetate 1200 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
132788|NCT01824589|B5|Baseline|Total|Total of all reporting groups
132715|NCT01825408|O1|Outcome|Doxycycline, 3 Weeks|"Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.~Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
132716|NCT01825408|E4|Reported Event|Azithromycin, 6 Weeks|"Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration.~Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
132717|NCT01825408|E3|Reported Event|Azithromycin, 3 Weeks|"Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration.~Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
132718|NCT01825408|E2|Reported Event|Doxycycline, 6 Weeks|"Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 6 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.~Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
132719|NCT01825408|E1|Reported Event|Doxycycline, 3 Weeks|"Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.~Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
132720|NCT01825200|B3|Baseline|Total|Total of all reporting groups
132721|NCT01825200|B2|Baseline|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
132722|NCT01825200|B1|Baseline|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
132723|NCT01825200|P2|Participant Flow|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
132724|NCT01825200|P1|Participant Flow|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
132725|NCT01825200|O2|Outcome|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
132726|NCT01825200|O1|Outcome|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
132727|NCT01825200|O2|Outcome|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
132728|NCT01825200|O1|Outcome|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
132729|NCT01825200|O2|Outcome|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
132778|NCT01824602|P2|Participant Flow|Group 3: Eslicarbazepine Acetate 600 mg|"Eslicarbazepine acetate 600 mg~Eslicarbazepine acetate 600 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
132732|NCT01825200|O1|Outcome|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
132733|NCT01825200|E2|Reported Event|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
132734|NCT01825200|E1|Reported Event|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
132735|NCT01825122|B3|Baseline|Total|Total of all reporting groups
132736|NCT01825122|B2|Baseline|Active, Nadolol|"Active~Nadolol"
132737|NCT01825122|B1|Baseline|Placebo|"placebo~Placebo"
132738|NCT01825122|P2|Participant Flow|Active, Nadolol|"Active~Nadolol"
132739|NCT01825122|P1|Participant Flow|Placebo|"placebo~Placebo"
132740|NCT01825122|O2|Outcome|Active, Nadolol|"Active~Nadolol"
132741|NCT01825122|O1|Outcome|Placebo|"placebo~Placebo"
132742|NCT01825122|E2|Reported Event|Active, Nadolol|"Active~Nadolol"
132743|NCT01825122|E1|Reported Event|Placebo|"placebo~Placebo"
132744|NCT01824979|B3|Baseline|Total|Total of all reporting groups
132745|NCT01824979|B2|Baseline|Other CPAP Mask|"Other CPAP mask during CPAP titration~Other CPAP mask"
132746|NCT01824979|B1|Baseline|Pilairo|"Pilairo nasal pillows mask during CPAP titration~CPAP mask ( Pilairo)"
132747|NCT01824979|P2|Participant Flow|Other CPAP Mask|"Other CPAP mask during CPAP titration~Other CPAP mask"
132748|NCT01824979|P1|Participant Flow|Pilairo|"Pilairo nasal pillows mask during CPAP titration~CPAP mask ( Pilairo)"
132749|NCT01824979|O2|Outcome|Other CPAP Mask|"Other CPAP mask during CPAP titration~Other CPAP mask"
132750|NCT01824979|O1|Outcome|Pilairo|"Pilairo nasal pillows mask during CPAP titration~CPAP mask ( Pilairo)"
132751|NCT01824979|O2|Outcome|Other CPAP Mask|"Other CPAP mask during CPAP titration~Other CPAP mask"
132752|NCT01824979|O1|Outcome|Pilairo|"Pilairo nasal pillows mask during CPAP titration~CPAP mask ( Pilairo)"
132753|NCT01824979|E2|Reported Event|Other CPAP Mask|"Other CPAP mask during CPAP titration~Other CPAP mask"
132754|NCT01824979|E1|Reported Event|Pilairo|"Pilairo nasal pillows mask during CPAP titration~CPAP mask ( Pilairo)"
132755|NCT01824901|B1|Baseline|Phase I|Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 2-15 of course 1 and days 1-14 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
132756|NCT01824901|P4|Participant Flow|Phase II Step II|"Patients receive FGFR inhibitor AZD4547 PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~AZD4547: Given PO"
132757|NCT01824901|P3|Participant Flow|Arm II (Docetaxel and AZD4547; Phase II Step I)|"Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 1-14. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~AZD4547: Given PO"
132758|NCT01824901|P2|Participant Flow|Arm I (Docetaxel; Phase II Step I)|"Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who experience progressive disease may then register to step II treatment and receive FGFR inhibitor AZD4547 PO BID on days 1-14.~docetaxel: Given IV"
132759|NCT01824901|P1|Participant Flow|Phase I|"Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 2-15 of course 1 and days 1-14 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~AZD4547: Given PO"
132760|NCT01824901|O1|Outcome|Phase I|Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 2-15 of course 1 and days 1-14 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
132761|NCT01824901|E1|Reported Event|Phase I|Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 2-15 of course 1 and days 1-14 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
132762|NCT01824823|B3|Baseline|Total|Total of all reporting groups
132763|NCT01824823|B2|Baseline|Arm B (Placebo)|Patients receive placebo PO QD on days 1-28.
132764|NCT01824823|B1|Baseline|Arm A (Afatinib)|Patients receive afatinib PO QD on days 1-28.
132765|NCT01824823|P2|Participant Flow|Arm B (Placebo)|Patients receive placebo PO QD on days 1-28.
132766|NCT01824823|P1|Participant Flow|Arm A (Afatinib)|Patients receive afatinib PO QD on days 1-28.
132767|NCT01824823|O2|Outcome|Arm B (Placebo)|Patients receive placebo PO QD on days 1-28.
132768|NCT01824823|O1|Outcome|Arm A (Afatinib)|Patients receive afatinib PO QD on days 1-28.
132769|NCT01824823|E2|Reported Event|Arm B (Placebo)|Patients receive placebo PO QD on days 1-28.
132770|NCT01824823|E1|Reported Event|Arm A (Afatinib)|Patients receive afatinib PO QD on days 1-28.
132771|NCT01824602|B5|Baseline|Total|Total of all reporting groups
132772|NCT01824602|B4|Baseline|Group 1: Eslicarbazepine Acetate 1800 mg|"Eslicarbazepine acetate 1800 mg~Eslicarbazepine acetate 1800 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
132773|NCT01824602|B3|Baseline|Group 2: Eslicarbazepine Acetate 1200 mg|"Eslicarbazepine acetate 1200 mg~Eslicarbazepine acetate 1200 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
132774|NCT01824602|B2|Baseline|Group 3: Eslicarbazepine Acetate 600 mg|"Eslicarbazepine acetate 600 mg~Eslicarbazepine acetate 600 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
132775|NCT01824602|B1|Baseline|Group 4: Placebo|"Placebo pills~Placebo : Placebo sugar pills"
132789|NCT01824589|B4|Baseline|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
132790|NCT01824589|B3|Baseline|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
132791|NCT01824589|B2|Baseline|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
132792|NCT01824589|B1|Baseline|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
132793|NCT01824589|P4|Participant Flow|Group D|"no device (washout) with tidal volume setting of 8ml/kg for 20 minutes, then 8ml/kg with the -12cm H2O ITPR as first device for 15 minutes, then tidal volume decreased to 6ml/kg with the -12cm H2O ITPR for 15 minutes, then no device with 6ml/kg for 20 minutes, then 6ml/kg with -7cm H2O ITPR for 15 minutes, then 8ml/kg with -7cm H2O ITPR for 15 minutes, then no device with 8ml/kg.~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
132794|NCT01824589|P3|Participant Flow|Group C|"no device (washout) with tidal volume setting of 6ml/kg for 20 minutes, then 6ml/kg with the -12cm H2O ITPR as first device for 15 minutes, then tidal volume increased to 8ml/kg with the -12cm H2O ITPR for 15 minutes, then no device with 8ml/kg for 20 minutes, then 8ml/kg with -7cm H2O ITPR for 15 minutes, then 6ml/kg with -7cm H2O ITPR for 15 minutes, then no device with 6ml/kg.~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
132795|NCT01824589|P2|Participant Flow|Group B|"no device (washout) with tidal volume setting of 8ml/kg for 20 minutes, then 8ml/kg with the -7cm H2O ITPR as first device for 15 minutes, then tidal volume decreased to 6ml/kg with the -7cm H2O ITPR for 15 minutes, then no device with 6ml/kg for 20 minutes, then 6ml/kg with -12cm H2O ITPR for 15 minutes, then 8ml/kg with -12cm H2O ITPR for 15 minutes, then no device with 8ml/kg.~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
132796|NCT01824589|P1|Participant Flow|Group A|"no device (washout) with tidal volume setting of 6ml/kg for 20 minutes, then 6ml/kg with the -7cm H2O ITPR as first device for 15 minutes, then tidal volume increased to 8ml/kg with the -7cm H2O ITPR for 15 minutes, then no device with 8ml/kg for 20 minutes, then 8ml/kg with -12cm H2O ITPR for 15 minutes, then 6ml/kg with -12cm H2O ITPR for 15 minutes, then no device with 6ml/kg.~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
132797|NCT01824589|O4|Outcome|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
132798|NCT01824589|O3|Outcome|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
132799|NCT01824589|O2|Outcome|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
132800|NCT01824589|O1|Outcome|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
132801|NCT01824589|O4|Outcome|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
132802|NCT01824589|O3|Outcome|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
132862|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
132863|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
157768|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter (Q4) 2010
132803|NCT01824589|O2|Outcome|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
132804|NCT01824589|O1|Outcome|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
132805|NCT01824589|O4|Outcome|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
132806|NCT01824589|O3|Outcome|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
132807|NCT01824589|O2|Outcome|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
132808|NCT01824589|O1|Outcome|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
132809|NCT01824589|O4|Outcome|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
132810|NCT01824589|O3|Outcome|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
132811|NCT01824589|O2|Outcome|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
132812|NCT01824589|O1|Outcome|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
132813|NCT01824589|E4|Reported Event|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
132814|NCT01824589|E3|Reported Event|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
132815|NCT01824589|E2|Reported Event|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
132816|NCT01824589|E1|Reported Event|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
132817|NCT01824576|B1|Baseline|ITPR|"Use of the ITPR for 120 minutes.~ITPR: Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations."
132818|NCT01824576|P1|Participant Flow|ITPR|"Use of the ITPR for 120 minutes.~ITPR: Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations."
132819|NCT01824576|O1|Outcome|ITPR|"Use of the ITPR for 120 minutes.~ITPR: Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations."
132820|NCT01824576|O1|Outcome|ITPR|"Use of the ITPR for 120 minutes.~ITPR: Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations."
132821|NCT01824576|O1|Outcome|ITPR|"Use of the ITPR for 120 minutes.~ITPR: Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations."
132822|NCT01824576|O1|Outcome|ITPR|"Use of the ITPR for 120 minutes.~ITPR: Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations."
132823|NCT01824576|O1|Outcome|ITPR|"Use of the ITPR for 120 minutes.~ITPR: Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations."
132824|NCT01824576|O1|Outcome|ITPR|"Use of the ITPR for 120 minutes.~ITPR: Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations."
132825|NCT01824576|O1|Outcome|ITPR|"Use of the ITPR for 120 minutes.~ITPR: Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations."
132826|NCT01824576|O1|Outcome|ITPR|"Use of the ITPR for 120 minutes.~ITPR: Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations."
132827|NCT01824576|O1|Outcome|ITPR|"Use of the ITPR for 120 minutes.~ITPR: Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations."
132828|NCT01824576|E1|Reported Event|ITPR|"Use of the ITPR for 120 minutes.~ITPR: Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations."
132829|NCT01824498|B7|Baseline|Total|Total of all reporting groups
132830|NCT01824498|B6|Baseline|Low Fat High Omega 3, Low Fat, High Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
132831|NCT01824498|B5|Baseline|Low Fat High Omega 3, High Fat, Low Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
132832|NCT01824498|B4|Baseline|High Fat, Low Fat High Omega 3, Low Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
132833|NCT01824498|B3|Baseline|High Fat, Low Fat, Low Fat High Omega 3|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
132834|NCT01824498|B2|Baseline|Low Fat, Low Fat High Omega 3, High Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
132835|NCT01824498|B1|Baseline|Low Fat, High Fat, Low Fat High Omega 3|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
132836|NCT01824498|P6|Participant Flow|Low Fat High Omega 3, Low Fat, High Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
132837|NCT01824498|P5|Participant Flow|Low Fat High Omega 3, High Fat, Low Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
132838|NCT01824498|P4|Participant Flow|High Fat, Low Fat High Omega 3, Low Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
132839|NCT01824498|P3|Participant Flow|High Fat, Low Fat, Low Fat High Omega 3|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
132840|NCT01824498|P2|Participant Flow|Low Fat, Low Fat High Omega 3, High Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
132841|NCT01824498|P1|Participant Flow|Low Fat, High Fat, Low Fat High Omega 3|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
132842|NCT01824498|O3|Outcome|Low Fat, High n3 Diet|Low fat, n3 diet = 20% fat + 3% n3
132843|NCT01824498|O2|Outcome|Low Fat Diet|Low fat diet = 20% fat
132844|NCT01824498|O1|Outcome|High Fat Diet|Hig fat diet = 40% fat
132845|NCT01824498|E3|Reported Event|Low Fat, High n3 Diet|Low fat, high n3 diet = 20% fat + 3% n3
132846|NCT01824498|E2|Reported Event|Low Fat Diet|Low fat diet = 20% fat
132847|NCT01824498|E1|Reported Event|High Fat Diet|High fat diet = 40% fat
132848|NCT01824446|B1|Baseline|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
132849|NCT01824446|P1|Participant Flow|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
132850|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
132851|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
132852|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
132853|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
132854|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
132855|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
132856|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
132857|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
132858|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
132859|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
132860|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
132861|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
157769|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
132864|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
132865|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
132866|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
132867|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
132868|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
132869|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
132870|NCT01824446|E1|Reported Event|[14C]SSP-004184|
132871|NCT01824355|B1|Baseline|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
132872|NCT01824355|P1|Participant Flow|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System. General enrollment criteria for the 'Intended Users' population:~At least 60% of subjects were younger than 65 years of age.~At least 20% had type 1 diabetes.~At least 50% with type 2 diabetes were insulin users.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
132873|NCT01824355|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
132874|NCT01824355|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
132875|NCT01824355|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
132876|NCT01824355|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
132877|NCT01824355|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
132878|NCT01824355|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
132879|NCT01824355|E1|Reported Event|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System. General enrollment criteria for the 'Intended Users' population:~At least 60% of subjects were younger than 65 years of age.~At least 20% had type 1 diabetes.~At least 50% with type 2 diabetes were insulin users.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
132880|NCT01824342|B3|Baseline|Total|Total of all reporting groups
132881|NCT01824342|B2|Baseline|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
132882|NCT01824342|B1|Baseline|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
132883|NCT01824342|P2|Participant Flow|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
132884|NCT01824342|P1|Participant Flow|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
132885|NCT01824342|O2|Outcome|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
132886|NCT01824342|O1|Outcome|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
132887|NCT01824342|O2|Outcome|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
157770|NCT01717989|O4|Outcome|Q3 2011|Third quarter (Q3) 2011
132888|NCT01824342|O1|Outcome|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
132889|NCT01824342|O2|Outcome|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
132890|NCT01824342|O1|Outcome|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
132891|NCT01824342|O2|Outcome|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
132892|NCT01824342|O1|Outcome|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
132893|NCT01824342|E2|Reported Event|Denosumab/ Denosumab 120 mg Q4W|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
132894|NCT01824342|E1|Reported Event|Placebo/ Denosumab 120 mg Q4W|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
132895|NCT01824303|B3|Baseline|Total|Total of all reporting groups
132896|NCT01824303|B2|Baseline|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
132897|NCT01824303|B1|Baseline|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
132898|NCT01824303|P2|Participant Flow|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
132899|NCT01824303|P1|Participant Flow|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
132900|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
132901|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
132902|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
132903|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
132904|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
132905|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
132906|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
132907|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
132908|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
132909|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
132910|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
132911|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
132912|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
132913|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
132914|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
132915|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
132916|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
132917|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
132918|NCT01824303|E4|Reported Event|LiRIS Placebo/LiRIS 400 mg _Open Label Extension|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days in the randomized study then LiRIS 400 mg in the Open Label Extension.
132919|NCT01824303|E3|Reported Event|LiRIS 400 mg_Open Label Extension|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days in the randomized study then LiRIS 400 mg in the Open Label Extension.
132920|NCT01824303|E2|Reported Event|LiRIS Placebo_Randomized Study|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days in the randomized study.
132921|NCT01824303|E1|Reported Event|LiRIS 400 mg_Randomized Study|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days in the randomized study.
132922|NCT01824160|B1|Baseline|Repair of RV-PA Conduit Disruption|"Covered stenting of RV-PA conduit injury~Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption"
132923|NCT01824160|P1|Participant Flow|Repair of RV-PA Conduit Disruption|"Covered stenting of RV-PA conduit injury~Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption"
133226|NCT01822665|O2|Outcome|Ibuprofen Tablet (400 mg)|Two ibuprofen capsules (400 mg/tablet), were administered TID, orally with water.
132924|NCT01824160|O1|Outcome|Repair of RV-PA Conduit Disruption|"Covered stenting of RV-PA conduit injury~Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption"
132925|NCT01824160|E1|Reported Event|Repair of RV-PA Conduit Disruption|"Covered stenting of RV-PA conduit injury~Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption"
132926|NCT01823679|B1|Baseline|Capecitabine 1000 mg/m²|Participants are to receive 500 mg/m² of capecitabine orally (PO) twice daily (BID) on days 1 to 14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.
132927|NCT01823679|P1|Participant Flow|Capecitabine 1000 mg/m²|Participants are to receive 500 mg/m² of capecitabine orally (PO) twice daily (BID) on days 1 to 14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.
132928|NCT01823679|O1|Outcome|Capecitabine 1000 mg/m2|"Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m2 doses on days 1 to 14.~Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given orally (PO)"
132929|NCT01823679|O1|Outcome|Capecitabine 1000 mg/m2|"Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m2 doses on days 1 to 14.~Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given orally (PO)"
132930|NCT01823679|O1|Outcome|Capecitabine 1000 mg/m2|"Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m2 doses on days 1 to 14.~Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given orally (PO)"
132931|NCT01823679|O1|Outcome|Capecitabine 1000 mg/m2|"Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m2 doses on days 1 to 14.~Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given orally (PO)"
132932|NCT01823679|O1|Outcome|Capecitabine 1000 mg/m²|"Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m2 doses on days 1 to 14.~Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given orally (PO)"
132933|NCT01823679|E1|Reported Event|Capecitabine 1000 mg/m²|Participants are to receive 500 mg/m² of capecitabine orally (PO) twice daily (BID) on days 1 to 14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.
132934|NCT01823653|B1|Baseline|Treated Thigh|Subjects randomly received treatment of either the left or right thigh with the Liposonix System (Model 2)
132935|NCT01823653|P1|Participant Flow|Treated Thigh|Randomly chosen left or right thigh treated with the Liposonix System (Model 2)
132936|NCT01823653|O1|Outcome|Treated Thigh|Subjects randomly received treatment of either the left or right thigh with the Liposonix System (Model 2)
132937|NCT01823653|O1|Outcome|Treated Thigh|Randomly chosen left or right thigh treated with the Liposonix System (Model 2)
132938|NCT01823653|O1|Outcome|Treated Thigh|Subjects randomly received treatment of either the left or right thigh with the Liposonix System (Model 2)
132939|NCT01823653|O2|Outcome|Control Thigh|Each subject's own thigh untreated during study
132940|NCT01823653|O1|Outcome|Treated Thigh|Randomly assigned left or right thigh that received treatment with Liposonix System (Model 2)
132941|NCT01823653|E1|Reported Event|Treated Thigh|Randomly chosen left or right thigh treated with the Liposonix System (Model 2)
132942|NCT01823614|B7|Baseline|Total|Total of all reporting groups
132943|NCT01823614|B6|Baseline|ARVT >3 Years|The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
132944|NCT01823614|B5|Baseline|ARVT From 6 Months to 3 Years|The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years
132945|NCT01823614|B4|Baseline|ARVT <6 Months|The group contains patients who have ARVT experience and obtain ART treatment less than 6 months
132946|NCT01823614|B3|Baseline|Naïve Patients, <350|The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3
132947|NCT01823614|B2|Baseline|Naïve Patients, 350-500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3
132948|NCT01823614|B1|Baseline|Naïve Patients, >500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3
132949|NCT01823614|P6|Participant Flow|ARVT >3 Years|The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
132950|NCT01823614|P5|Participant Flow|ARVT From 6 Months to 3 Years|The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years
132951|NCT01823614|P4|Participant Flow|ARVT <6 Months|The group contains patients who have ARVT experience and obtain ART treatment less than 6 months
132952|NCT01823614|P3|Participant Flow|Naïve Patients, <350|The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3
132953|NCT01823614|P2|Participant Flow|Naïve Patients, 350-500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3
132954|NCT01823614|P1|Participant Flow|Naïve Patients, >500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3
132955|NCT01823614|O3|Outcome|CD4 Cell Count < 350|Group which contains naive patients with CD4 nadir less than 350 cell/mkl at the moment of enrollment
132956|NCT01823614|O2|Outcome|CD4 Cell Count 350-500|Group which contains naive patients with CD4 nadir between 350 and 500 cell/mkl at the moment of enrollment
132957|NCT01823614|O1|Outcome|CD4 Cell Count > 500|Group which contains naive patients with CD4 nadir more than 500 cell/mkl at the moment of enrollment
132958|NCT01823614|O3|Outcome|CD4 Cell Count < 350|Group which contains patients with CD4 nadir less than 350 cell/mkl at the moment of enrollment
132959|NCT01823614|O2|Outcome|CD4 Cell Count 350-500|Group which contains patients with CD4 nadir between 350 and 500 cell/mkl at the moment of enrollment
132960|NCT01823614|O1|Outcome|CD4 Cell Count > 500|Group which contains patients with CD4 nadir more than 500 cell/mkl at the moment of enrollment
132961|NCT01823614|O6|Outcome|ARVT >3 Years|The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
132962|NCT01823614|O5|Outcome|ARVT From 6 Months to 3 Years|The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years
132963|NCT01823614|O4|Outcome|ARVT <6 Months|The group contains patients who have ARVT experience and obtain ART treatment less than 6 months
132964|NCT01823614|O3|Outcome|Naïve Patients, <350|The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3
132965|NCT01823614|O2|Outcome|Naïve Patients, 350-500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3
132966|NCT01823614|O1|Outcome|Naïve Patients, >500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3
132967|NCT01823614|E6|Reported Event|ARVT >3 Years|The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
132968|NCT01823614|E5|Reported Event|ARVT From 6 Months to 3 Years|The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years
132969|NCT01823614|E4|Reported Event|ARVT <6 Months|The group contains patients who have ARVT experience and obtain ART treatment less than 6 months
132970|NCT01823614|E3|Reported Event|Naïve Patients, <350|The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3
132971|NCT01823614|E2|Reported Event|Naïve Patients, 350-500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3
132972|NCT01823614|E1|Reported Event|Naïve Patients, >500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3
132973|NCT01823536|B7|Baseline|Total|Total of all reporting groups
132974|NCT01823536|B6|Baseline|Not Assigned|Two subjects 2-5 years of age were randomized to receive another meningococcal ACWY vaccine (not the investigational product in the extension study) in the parent study and therefore not eligible for enrolment into the extension study. These subjects were inadvertently enrolled and completed the extension study. During analysis, these two subjects were included in a separate “not assigned” group in the FAS and excluded from the PPS. However, one of these subjects actually received the investigational vaccine (due to a randomization error) in the parent study and was included in the safety analyses under MenACWY-CRM_1 (≥7–≤10 Years) group in the extension study.
132975|NCT01823536|B5|Baseline|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
132976|NCT01823536|B4|Baseline|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
132977|NCT01823536|B3|Baseline|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
132978|NCT01823536|B2|Baseline|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
132979|NCT01823536|B1|Baseline|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
132980|NCT01823536|P6|Participant Flow|Not Assigned|"Two subjects 2-5 years of age were randomized to receive another meningococcal ACWY vaccine (not the investigational product in the extension study) in the parent study and therefore not eligible for enrolment into the extension study. These subjects were inadvertently enrolled and completed the extension study. During analysis, these two subjects were included in a separate not assigned group in the Full Analysis Set and excluded from the Per Protocol Set. However, one of these subjects actually received the investigational vaccine (due to a randomization error) in the parent study and was included in the safety analyses under MenACWY-CRM_1 (≥7–≤10 Years) group in the extension study."
132981|NCT01823536|P5|Participant Flow|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
132982|NCT01823536|P4|Participant Flow|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
132983|NCT01823536|P3|Participant Flow|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
132984|NCT01823536|P2|Participant Flow|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
132985|NCT01823536|P1|Participant Flow|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
132986|NCT01823536|O5|Outcome|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
132987|NCT01823536|O4|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
132988|NCT01823536|O3|Outcome|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
132989|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
132990|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
132991|NCT01823536|O5|Outcome|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
132992|NCT01823536|O4|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
133286|NCT01822535|O2|Outcome|Able-bodied (AB)|Age- and gender-matched to individuals with tetraplegia.
132993|NCT01823536|O3|Outcome|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
132994|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
132995|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
132996|NCT01823536|O5|Outcome|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
132997|NCT01823536|O4|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
132998|NCT01823536|O3|Outcome|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
132999|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
133000|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
133001|NCT01823536|O5|Outcome|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
133002|NCT01823536|O4|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
133003|NCT01823536|O3|Outcome|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
133004|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
133005|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
133006|NCT01823536|O5|Outcome|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
133007|NCT01823536|O4|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
133008|NCT01823536|O3|Outcome|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
133009|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
133010|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
133011|NCT01823536|O3|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
133012|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
133013|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
133014|NCT01823536|O3|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
133015|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
133016|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
133017|NCT01823536|E5|Reported Event|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
133018|NCT01823536|E4|Reported Event|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
133019|NCT01823536|E3|Reported Event|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
133020|NCT01823536|E2|Reported Event|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
133021|NCT01823536|E1|Reported Event|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
133022|NCT01823510|B1|Baseline|Type 2 Diabetic Patients|"All participants receive both Ticagrelor and Clopidogrel (each with aspirin) in a cross-over design. Treatment sequence (Tica-Clop OR Clop-Tica) was randomly assigned and with a 2-week washout period in between (i.e., Tica/Clop (5-7 days), Washout (14 days), and Clop/Tica (5-7 days))."
133023|NCT01823510|P2|Participant Flow|Clop-Tica|Participants received Clopidogrel plus ASA (loading-dose plus daily-dose for 5-7 days), followed by Washout (14 days), and then Ticagrelor plus ASA (loading-dose plus daily-dose for 5-7 days).
133227|NCT01822665|O1|Outcome|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/tablet), were administered TID, orally with water.
133024|NCT01823510|P1|Participant Flow|Tica-Clop|Participants received Ticagrelor plus ASA (loading-dose plus daily-dose for 5-7 days), followed by Washout (14 days), and then Clopidogrel plus ASA (loading-dose plus daily-dose for 5-7 days).
133025|NCT01823510|O2|Outcome|Clopidogrel + Aspirin|Single loading doses of Clopidogrel (600 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (clopidogrel 75 mg + ASA 81 mg once daily).
133026|NCT01823510|O1|Outcome|Ticagrelor + Aspirin|Single loading doses of Ticagrelor (180 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (ticagrelor 90 mg twice daily + ASA 81 mg once daily).
133027|NCT01823510|O2|Outcome|Clopidogrel + Aspirin|Single loading doses of Clopidogrel (600 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (clopidogrel 75 mg + ASA 81 mg once daily).
133028|NCT01823510|O1|Outcome|Ticagrelor + Aspirin|Single loading doses of Ticagrelor (180 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (ticagrelor 90 mg twice daily + ASA 81 mg once daily).
133029|NCT01823510|O2|Outcome|Clopidogrel + Aspirin|Single loading doses of Clopidogrel (600 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (clopidogrel 75 mg + ASA 81 mg once daily).
133030|NCT01823510|O1|Outcome|Ticagrelor + Aspirin|Single loading doses of Ticagrelor (180 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (ticagrelor 90 mg twice daily + ASA 81 mg once daily).
133031|NCT01823510|O2|Outcome|Clopidogrel + Aspirin|Single loading doses of Clopidogrel (600 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (clopidogrel 75 mg + ASA 81 mg once daily).
133032|NCT01823510|O1|Outcome|Ticagrelor + Aspirin|Single loading doses of Ticagrelor (180 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (ticagrelor 90 mg twice daily + ASA 81 mg once daily).
133033|NCT01823510|E2|Reported Event|Clopidrogel + Aspirin|Single loading doses of Clopidogrel (600 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (clopidogrel 75 mg + ASA 81 mg once daily).
133034|NCT01823510|E1|Reported Event|Ticagrelor + Aspirin|Single loading doses of Ticagrelor (180 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (ticagrelor 90 mg twice daily + ASA 81 mg once daily).
133035|NCT01823341|B1|Baseline|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
133036|NCT01823341|P1|Participant Flow|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
133037|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
133038|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
133039|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
133040|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
133041|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
133042|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
133043|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
133044|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
133045|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
133046|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
133047|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
133089|NCT01823224|O2|Outcome|Group 2|This group consisted of 22 subjects that received the oral acetaminophen and IV placebo. Of the 22 there was 1 male and 21 female.
133090|NCT01823224|O1|Outcome|Group 1|This group consisted of 28 subjects' data that was analyzed. Of the 28 there were 7 males 21 females.
133048|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
133049|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
133050|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
133051|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
133052|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
133053|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
133054|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
133055|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
133056|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
133057|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
133058|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
133059|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
133060|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
133061|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
133062|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
133063|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
133064|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
133065|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
133066|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
133067|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
133068|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
133069|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
133070|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
133071|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
133072|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
133073|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
133074|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
133075|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
133076|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
133077|NCT01823341|E1|Reported Event|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
133078|NCT01823289|B1|Baseline|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
133079|NCT01823289|P1|Participant Flow|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
133080|NCT01823289|O1|Outcome|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
133081|NCT01823289|O1|Outcome|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
133082|NCT01823289|O1|Outcome|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
133083|NCT01823289|E1|Reported Event|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
133084|NCT01823224|B3|Baseline|Total|Total of all reporting groups
133085|NCT01823224|B2|Baseline|Group 2|"Group 2 will receive an IV salt water infusion plus 2 capsules of oral acetaminophen 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses totaling or equaling 2000mg.~2 capsules Oral Tylenol 2000 mg and IV salt water: The participants randomized to receive the '2 capsules Oral Acetaminophenl 500 mg and IV salt water repeated 4 hours after that dose to equal 2000mg. A pre-op pain score was obtained and pain scores every 15 min x 1 hour then per recovery routine and they did a 24 hour home diary to record pain scores for 24 hours post surgery. Their opioid morphine equivalent was recorded intraoperatively, recovery and at home. This was compared to the other group receiving IV acetaminophen.and the pain scores and morphine equivalents were collected the same as in the comparative group. Each group received a placebo version oral or iv accordingly."
133086|NCT01823224|B1|Baseline|Group 1|"Group 1 will receive IV acetaminophen 1000mg plus 2 oral capsules sugar pills 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses of acetaminophen totaling or equaling 2000mg~IV tylenol 1000mg and 2 oral capsule sugar pills: IV acetaminophen 1000mg and 2 oral capsule sugar pills were given to participants that were randomized to receive the IV acetaminophen. The same collection of pain scores and morphine equivalents was completed the same as the other group."
133087|NCT01823224|P2|Participant Flow|"Oral Acetaminophen 2 Capsules + IV Salt Water"|"Group 2 will receive an IV salt water infusion plus 2 capsules of oral acetaminophen 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses totaling or equaling 2000mg.~2 capsules Oral Tylenol 2000 mg and IV salt water: The participants randomized to receive the '2 capsules Oral Acetaminophenl 500 mg and IV salt water repeated 4 hours after that dose to equal 2000mg. A pre-op pain score was obtained and pain scores every 15 min x 1 hour then per recovery routine and they did a 24 hour home diary to record pain scores for 24 hours post surgery. Their opioid morphine equivalent was recorded intraoperatively, recovery and at home. This was compared to the other group receiving IV acetaminophen.and the pain scores and morphine equivalents were collected the same as in the comparative group. Each group received a placebo version oral or iv accordingly."
133088|NCT01823224|P1|Participant Flow|"IV Acetaminophen 1000mg + 2 Oral Sugar Pills"|"Group 1 will receive IV acetaminophen 1000mg plus 2 oral capsules sugar pills 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses of acetaminophen totaling or equaling 2000mg~IV tylenol 1000mg and 2 oral capsule sugar pills: IV acetaminophen 1000mg and 2 oral capsule sugar pills were given to participants that were randomized to receive the IV acetaminophen. The same collection of pain scores and morphine equivalents was completed the same as the other group."
133228|NCT01822665|O4|Outcome|Placebo Tablet|Two placebo tablets were administered QID, orally with water.
133091|NCT01823224|O2|Outcome|Group 2|A Repeated Analyses of Variance was conducted to determine if there were significant differences between the IV and PO groups relative to pain over seven times. There were no significant differences between the groups over time, Wilks’ Lambda (P = 0.875). (Table 4 and Figure 1)
133092|NCT01823224|O1|Outcome|Group 1|A Repeated Analyses of Variance was conducted to determine if there were significant differences between the IV and PO groups relative to pain over seven times.
133093|NCT01823224|E2|Reported Event|Group 2|No adverse events
133094|NCT01823224|E1|Reported Event|Group 1|.Found to have gangreouns gallbladder and stayed greater 24 hours; upon investigation found not related to the acetaminophen
133095|NCT01823146|B3|Baseline|Total|Total of all reporting groups
133096|NCT01823146|B2|Baseline|Placebo Spray|single dose of 24 IU saline, self-administered intranasally (IN)
133097|NCT01823146|B1|Baseline|Oxytocin Spray|single dose of 24 IU oxytocin, self-administered intranasally (IN)
133098|NCT01823146|P2|Participant Flow|Placebo Spray|single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
133099|NCT01823146|P1|Participant Flow|Oxytocin Spray|single dose of 24 IU oxytocin, self-administered intranasally (IN)
133100|NCT01823146|O2|Outcome|Placebo Spray|single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
133101|NCT01823146|O1|Outcome|Oxytocin Spray|single dose of 24 IU oxytocin, self-administered intranasally (IN)
133102|NCT01823146|O2|Outcome|Placebo Spray|single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
133103|NCT01823146|O1|Outcome|Oxytocin Spray|single dose of 24 IU oxytocin, self-administered intranasally (IN)
133104|NCT01823146|O2|Outcome|Placebo Spray|single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
133105|NCT01823146|O1|Outcome|Oxytocin Spray|single dose of 24 IU oxytocin, self-administered intranasally (IN)
133106|NCT01823146|E2|Reported Event|Placebo Spray|"single dose of 24 IU saline, self-administered intranasally (IN)~Placebo spray: single dose of 24 IU saline, self-administered intranasally (IN)"
133107|NCT01823146|E1|Reported Event|Oxytocin Spray|"single dose of 24 IU oxytocin, self-administered intranasally (IN)~Oxytocin spray: single dose of 24 IU oxytocin, self-administered intranasally (IN)"
133108|NCT01822899|B3|Baseline|Total|Total of all reporting groups
133109|NCT01822899|B2|Baseline|FSC 500/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
133110|NCT01822899|B1|Baseline|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks.
133111|NCT01822899|P2|Participant Flow|FSC 500/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
133112|NCT01822899|P1|Participant Flow|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks.
133113|NCT01822899|O2|Outcome|FSC 500/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
133114|NCT01822899|O1|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks.
133115|NCT01822899|O2|Outcome|FSC 500/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
133116|NCT01822899|O1|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks.
133117|NCT01822899|E2|Reported Event|FSC 500/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
133118|NCT01822899|E1|Reported Event|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks.
133119|NCT01822821|B3|Baseline|Total|Total of all reporting groups
133120|NCT01822821|B2|Baseline|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
133121|NCT01822821|B1|Baseline|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
133122|NCT01822821|P2|Participant Flow|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
133123|NCT01822821|P1|Participant Flow|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
133192|NCT01822756|E5|Reported Event|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
133124|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
133125|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
133126|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
133127|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
133128|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
133129|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
133130|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
133131|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
133132|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
133133|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
133134|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
133135|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
133136|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
133137|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
133138|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
133139|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
133140|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
133141|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
133142|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
133143|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
133144|NCT01822821|E2|Reported Event|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
133193|NCT01822756|E4|Reported Event|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
133194|NCT01822756|E3|Reported Event|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
133145|NCT01822821|E1|Reported Event|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
133146|NCT01822756|B6|Baseline|Total|Total of all reporting groups
133147|NCT01822756|B5|Baseline|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
133148|NCT01822756|B4|Baseline|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
133149|NCT01822756|B3|Baseline|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
133150|NCT01822756|B2|Baseline|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
133151|NCT01822756|B1|Baseline|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
133152|NCT01822756|P5|Participant Flow|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
133153|NCT01822756|P4|Participant Flow|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
133154|NCT01822756|P3|Participant Flow|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
133155|NCT01822756|P2|Participant Flow|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
133156|NCT01822756|P1|Participant Flow|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
133157|NCT01822756|O5|Outcome|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
133158|NCT01822756|O4|Outcome|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
133159|NCT01822756|O3|Outcome|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
133160|NCT01822756|O2|Outcome|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
133161|NCT01822756|O1|Outcome|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
133162|NCT01822756|O5|Outcome|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
133163|NCT01822756|O4|Outcome|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
133164|NCT01822756|O3|Outcome|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
133165|NCT01822756|O2|Outcome|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
133166|NCT01822756|O1|Outcome|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
133167|NCT01822756|O5|Outcome|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
133168|NCT01822756|O4|Outcome|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
133169|NCT01822756|O3|Outcome|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
133170|NCT01822756|O2|Outcome|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
133171|NCT01822756|O1|Outcome|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
133172|NCT01822756|O5|Outcome|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
133173|NCT01822756|O4|Outcome|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
133174|NCT01822756|O3|Outcome|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
133175|NCT01822756|O2|Outcome|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
133176|NCT01822756|O1|Outcome|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
133177|NCT01822756|O5|Outcome|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
133178|NCT01822756|O4|Outcome|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
133179|NCT01822756|O3|Outcome|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
133180|NCT01822756|O2|Outcome|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
133181|NCT01822756|O1|Outcome|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
133182|NCT01822756|O5|Outcome|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
133183|NCT01822756|O4|Outcome|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
133184|NCT01822756|O3|Outcome|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
133185|NCT01822756|O2|Outcome|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
133186|NCT01822756|O1|Outcome|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
133187|NCT01822756|O5|Outcome|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
133188|NCT01822756|O4|Outcome|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
133189|NCT01822756|O3|Outcome|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
133190|NCT01822756|O2|Outcome|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
133191|NCT01822756|O1|Outcome|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
133195|NCT01822756|E2|Reported Event|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
133196|NCT01822756|E1|Reported Event|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
133197|NCT01822691|B1|Baseline|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
133198|NCT01822691|P1|Participant Flow|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
133199|NCT01822691|O1|Outcome|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
133200|NCT01822691|O1|Outcome|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
133201|NCT01822691|O1|Outcome|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
133202|NCT01822691|O1|Outcome|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
133203|NCT01822691|O1|Outcome|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
133204|NCT01822691|E1|Reported Event|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
133205|NCT01822678|B4|Baseline|Total|Total of all reporting groups
133206|NCT01822678|B3|Baseline|Placebo|"Group 3: Placebo (change in daily number of tablets administered, according to clinical response).~Placebo : Placebo, sugar pill"
133207|NCT01822678|B2|Baseline|BIA 2-093 - 1800 mg (Maximum Dose)|"Group 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response."
133208|NCT01822678|B1|Baseline|BIA 2-093 - 2400 mg (Maximum Dose)|"Group 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response."
133209|NCT01822678|P3|Participant Flow|Placebo|"Group 3: Placebo (change in daily number of tablets administered, according to clinical response).~Placebo : Placebo, sugar pill"
133210|NCT01822678|P2|Participant Flow|ESL 600 mg|"Group 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response."
133211|NCT01822678|P1|Participant Flow|ESL 800 mg|"Group 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response."
133212|NCT01822678|O3|Outcome|Placebo|"Group 3: Placebo (change in daily number of tablets administered, according to clinical response).~Placebo : Placebo, sugar pill"
133213|NCT01822678|O2|Outcome|BIA 2-093 - 1800 mg (Maximum Dose)|"Group 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response."
133214|NCT01822678|O1|Outcome|BIA 2-093 - 2400 mg (Maximum Dose)|"Group 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response."
133215|NCT01822678|E3|Reported Event|Placebo|"Group 3: Placebo (change in daily number of tablets administered, according to clinical response).~Placebo : Placebo, sugar pill"
133216|NCT01822678|E2|Reported Event|BIA 2-093 - 1800 mg (Maximum Dose)|"Group 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response."
133217|NCT01822678|E1|Reported Event|BIA 2-093 - 2400 mg (Maximum Dose)|"Group 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response."
133218|NCT01822665|B1|Baseline|All Randomized Participants|All randomized participants in the study who took at least one treatment dose.
133219|NCT01822665|P1|Participant Flow|Overall Study|This was a randomized, 4-way crossover study. Participants received two fast dissolving paracetamol tablets (500 milligrams [mg]/tablet) four times daily (QID); two liquid-filled gelatin capsules containing ibuprofen (200 mg/capsule), three times daily (TID); two ibuprofen tablets (200 mg/tablet), TID; and, two fast dissolving placebo tablets QID. All the treatments were administered orally with water. There was a washout period of 7 days following every treatment session.
133220|NCT01822665|O4|Outcome|Placebo Tablet|Two placebo tablets were administered QID, orally with water.
133221|NCT01822665|O3|Outcome|Ibuprofen Tablet (400 mg)|Two ibuprofen tablet (400 mg/tablet), were administered TID, orally with water.
133222|NCT01822665|O2|Outcome|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/capsule), were administered TID, orally with water.
133223|NCT01822665|O1|Outcome|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) were administered QID, orally with water.
133224|NCT01822665|O4|Outcome|Placebo Tablet|Two placebo tablets were administered QID, orally with water.
133225|NCT01822665|O3|Outcome|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) were administered QID, orally with water.
133229|NCT01822665|O3|Outcome|Ibuprofen Tablet (400 mg)|Two ibuprofen tablets (400 mg/tablet), were administered TID, orally with water.
133230|NCT01822665|O2|Outcome|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/tablet), were administered TID, orally with water.
133231|NCT01822665|O1|Outcome|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) were administered QID, orally with water.
133232|NCT01822665|O4|Outcome|Placebo Tablet|Two placebo tablets were administered QID, orally with water.
133233|NCT01822665|O3|Outcome|Ibuprofen Tablet (400 mg)|Two ibuprofen capsules (400 mg/tablet), were administered TID, orally with water.
133234|NCT01822665|O2|Outcome|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/tablet), were administered TID, orally with water.
133235|NCT01822665|O1|Outcome|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) were administered QID, orally with water.
133236|NCT01822665|O2|Outcome|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/tablet), was administered TID, orally with water.
133237|NCT01822665|O1|Outcome|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) was administered QID, orally with water.
133238|NCT01822665|E4|Reported Event|Placebo Tablet|Two placebo tablets were administered QID, orally with water.
133239|NCT01822665|E3|Reported Event|Ibuprofen Tablet (400 mg)|Two ibuprofen tablets (400 mg/tablet), were administered TID, orally with water.
133240|NCT01822665|E2|Reported Event|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/capsule), were administered TID, orally with water.
133241|NCT01822665|E1|Reported Event|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) were administered QID, orally with water.
133242|NCT01822574|B4|Baseline|Total|Total of all reporting groups
133243|NCT01822574|B3|Baseline|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
133244|NCT01822574|B2|Baseline|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
133245|NCT01822574|B1|Baseline|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
133246|NCT01822574|P3|Participant Flow|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
133247|NCT01822574|P2|Participant Flow|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
133248|NCT01822574|P1|Participant Flow|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
133249|NCT01822574|O3|Outcome|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
133250|NCT01822574|O2|Outcome|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
133251|NCT01822574|O1|Outcome|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
133252|NCT01822574|O3|Outcome|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
133253|NCT01822574|O2|Outcome|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
133284|NCT01822535|P1|Participant Flow|Tetraplegia|Lesion level C3-T1, American Spinal Injury Association (ASIA) impairment levels A and B, ages 18-68 years
133285|NCT01822535|O1|Outcome|Tetraplegia|Lesion level C3-T1, ASIA levels A and B, ages 18-68 years
133254|NCT01822574|O1|Outcome|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
133255|NCT01822574|O3|Outcome|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
133256|NCT01822574|O2|Outcome|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
133257|NCT01822574|O1|Outcome|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
133258|NCT01822574|E3|Reported Event|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
133259|NCT01822574|E2|Reported Event|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
133260|NCT01822574|E1|Reported Event|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
133261|NCT01822561|B1|Baseline|CSCR Patients Who Received Eplerenone|All patients were diagnosed with central serous chorioretinopathy. All patients received 50mg oral eplerenone daily for 4 weeks.
133262|NCT01822561|P1|Participant Flow|Eplerenone Group|"All patients in this study received Eplerenone 50mg once daily for 4 weeks.~Eplerenone 50mg: All patients received the same dose of eplerenone."
133263|NCT01822561|O1|Outcome|Patients That Received Eplerenone|Patients took oral Eplerenone 50mg once daily for 4 weeks.
133264|NCT01822561|O1|Outcome|Patients That Received Eplerenone|Patients received oral Eplerenone 50mg once daily for 4 weeks.
133265|NCT01822561|O1|Outcome|Patients That Took Eplerenone|Patients received oral Eplerenone 50mg once daily for 4 weeks.
133266|NCT01822561|O1|Outcome|Patients That Received Eplerenone|Patients took 50mg oral eplerenone daily for 1 month
133267|NCT01822561|O1|Outcome|Patients That Took Eplerenone|Patients received 50mg oral eplerenone daily for 1 month
133268|NCT01822561|E1|Reported Event|Eplerenone Group|All patients had central serous chorioretinopathy and were treated with 50mg oral eplerenone once daily
133269|NCT01822548|B3|Baseline|Total|Total of all reporting groups
133270|NCT01822548|B2|Baseline|Glibenclamide & Metformin|"Glibenclamide maximum dose of 10 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration~Glibenclamide: 2.5 mg (total daily), progressively increased up to a maximum dose of 5 mg x 2/ day."
133271|NCT01822548|B1|Baseline|Vildagliptin & Metformin|"Vildagliptin 100 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration~Vildagliptin: 100 mg daily"
133272|NCT01822548|P2|Participant Flow|Glibenclamide & Metformin|"Glibenclamide maximum dose of 10 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration~Glibenclamide: 2.5 mg (total daily), progressively increased up to a maximum dose of 5 mg x 2/ day."
133273|NCT01822548|P1|Participant Flow|Vildagliptin & Metformin|"Vildagliptin 100 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration~Vildagliptin: 100 mg daily"
133274|NCT01822548|O2|Outcome|Glibenclamide & Metformin|"Glibenclamide maximum dose of 10 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration~Glibenclamide: 2.5 mg (total daily), progressively increased up to a maximum dose of 5 mg x 2/ day."
133275|NCT01822548|O1|Outcome|Vildagliptin & Metformin|"Vildagliptin 100 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration~Vildagliptin: 100 mg daily"
133276|NCT01822548|O2|Outcome|Glibenclamide & Metformin|"Glibenclamide maximum dose of 10 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration~Glibenclamide: 2.5 mg (total daily), progressively increased up to a maximum dose of 5 mg x 2/ day."
133277|NCT01822548|O1|Outcome|Vildagliptin & Metformin|"Vildagliptin 100 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration~Vildagliptin: 100 mg daily"
133278|NCT01822548|E2|Reported Event|Glibenclamide & Metformin|"Glibenclamide maximum dose of 10 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration~Glibenclamide: 2.5 mg (total daily), progressively increased up to a maximum dose of 5 mg x 2/ day."
133279|NCT01822548|E1|Reported Event|Vildagliptin & Metformin|"Vildagliptin 100 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration~Vildagliptin: 100 mg daily"
133280|NCT01822535|B3|Baseline|Total|Total of all reporting groups
133281|NCT01822535|B2|Baseline|Able-bodied|Age- and gender-matched to individuals with tetraplegia.
133282|NCT01822535|B1|Baseline|Tetraplegia|Lesion level T1 and above, ASIA levels A and B, ages 18-68 years
133283|NCT01822535|P2|Participant Flow|Able-bodied (AB)|Age- and gender-matched to individuals with tetraplegia.
157771|NCT01717989|O3|Outcome|Q2 2011|Second quarter (Q2), 2011
133287|NCT01822535|O1|Outcome|Tetraplegia|Lesion level C3-T1, ASIA levels A and B, ages 18-68 years
133288|NCT01822535|O2|Outcome|Able-bodied|Age- and gender-matched to individuals with tetraplegia.
133289|NCT01822535|O1|Outcome|Tetraplegia|Lesion level C3-T1, ASIA levels A and B, ages 18-68 years
133290|NCT01822535|O2|Outcome|Able-bodied|Age- and gender-matched to individuals with tetraplegia.
133291|NCT01822535|O1|Outcome|Tetraplegia|Lesion level T1 and above, ASIA levels A and B, ages 18-68 years
133292|NCT01822535|E3|Reported Event|Drug: Tetraplegia|Those individuals with tetraplegia who completed visit 1 of testing (i.e. no drug)
133293|NCT01822535|E2|Reported Event|No Drug: Able-bodied|Age- and gender-matched to individuals with tetraplegia.
133294|NCT01822535|E1|Reported Event|No Drug: Tetraplegia|Lesion level C3-T1, ASIA levels A and B, ages 18-68 years
133295|NCT01822301|B1|Baseline|Repeat Facial Fat Grafting|Repeat Fat grafting: Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years. We treat 5 subjects from protocol (IRB # PRO09060101) with an additional fat graft treatment to assess whether this will increase fat graft retention over time. .
133296|NCT01822301|P1|Participant Flow|Repeat Facial Fat Grafting|Repeat Fat grafting: treat 5 subjects from protocol IRB # PRO09060101 with an additional fat graft treatment to assess whether this will increase fat graft retention over time.
133297|NCT01822301|O3|Outcome|CT Imaging at 9 Months PO|CT imaging at 9 months post-operation
133298|NCT01822301|O2|Outcome|CT Imaging at 3 Months PO|CT imaging at 3 months post-operation
133299|NCT01822301|O1|Outcome|CT Imaging at 7-21 Days PO|CT imaging at 7-21 days post-operation
133300|NCT01822301|O4|Outcome|Facial Volume Score at 9 Months PO|facial volume score at 3 months post-operation
133301|NCT01822301|O3|Outcome|Facial Volume Score at 3 Month PO|facial volume score at 3 months post-operation
133302|NCT01822301|O2|Outcome|Facial Volume Score at 7-21 Day PO|facial volume score at 7-21 days post-operation
133303|NCT01822301|O1|Outcome|Facial Volume Score at Baseline|facial volume score at baseline, pre-op
133304|NCT01822301|E1|Reported Event|Repeat Facial Fat Grafting|Repeat Fat grafting: treat 5 subjects from protocol IRB # PRO09060101 with an additional fat graft treatment to assess whether this will increase fat graft retention over time.
133305|NCT01822223|B3|Baseline|Total|Total of all reporting groups
133306|NCT01822223|B2|Baseline|Smooth Implant-abutments|"Smooth dental implant-abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
133307|NCT01822223|B1|Baseline|Laser-ablated Dental Implant-abutments|"Laser-ablated dental implant abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
133308|NCT01822223|P2|Participant Flow|Smooth Implant-abutments|Smooth dental implant-abutments will be attached to surgically placed dental implants.
133309|NCT01822223|P1|Participant Flow|Laser-ablated Dental Implant-abutments|Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
133310|NCT01822223|O2|Outcome|Smooth Implant-abutments|Smooth dental implant-abutments will be attached to surgically placed dental implants.
133311|NCT01822223|O1|Outcome|Laser-ablated Dental Implant-abutments|Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
133312|NCT01822223|O2|Outcome|Smooth Implant-abutments|Smooth dental implant-abutments will be attached to surgically placed dental implants.
133313|NCT01822223|O1|Outcome|Laser-ablated Dental Implant-abutments|Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
133314|NCT01822223|O2|Outcome|Smooth Implant-abutments|Smooth dental implant-abutments will be attached to surgically placed dental implants.
133315|NCT01822223|O1|Outcome|Laser-ablated Dental Implant-abutments|Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
133316|NCT01822223|O2|Outcome|Smooth Implant-abutments|"Smooth dental implant-abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
133317|NCT01822223|O1|Outcome|Laser-ablated Dental Implant-abutments|"Laser-ablated dental implant abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
133318|NCT01822223|O2|Outcome|Smooth Implant-abutments|"Smooth dental implant-abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
133319|NCT01822223|O1|Outcome|Laser-ablated Dental Implant-abutments|"Laser-ablated dental implant abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
133320|NCT01822223|O2|Outcome|Smooth Implant-abutments|"Smooth dental implant-abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
133321|NCT01822223|O1|Outcome|Laser-ablated Dental Implant-abutments|"Laser-ablated dental implant abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
133322|NCT01822223|E2|Reported Event|Smooth Implant-abutments|"Smooth dental implant-abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
133323|NCT01822223|E1|Reported Event|Laser-ablated Dental Implant-abutments|"Laser-ablated dental implant abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
133324|NCT01822197|B1|Baseline|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)~Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
133325|NCT01822197|P1|Participant Flow|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)~Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
133326|NCT01822197|O1|Outcome|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)~Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
133327|NCT01822197|O1|Outcome|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)~Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
133328|NCT01822197|O1|Outcome|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)~Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
133329|NCT01822197|E1|Reported Event|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)~Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
133330|NCT01822119|B1|Baseline|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
133331|NCT01822119|P1|Participant Flow|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
133332|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
133333|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
133334|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
133335|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
133336|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
133337|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
133338|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
133339|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
133340|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
133341|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
133342|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
133343|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
133344|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
133345|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
133346|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
133347|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
133348|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
133349|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
133350|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
133351|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
133352|NCT01822119|E1|Reported Event|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
133353|NCT01821963|B1|Baseline|Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir|Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care Pegylated Interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for Ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for Telaprevir 750 mg taken orally 3 times a day.
133354|NCT01821963|P1|Participant Flow|Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir|Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care Pegylated Interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for Ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for Telaprevir 750 mg taken orally 3 times a day.
133394|NCT01821534|P1|Participant Flow|All Participants|Healthy volunteers. No treatment (intervention) was administered.
157772|NCT01717989|O2|Outcome|Q1 2011|First quarter (Q1), 2011
133355|NCT01821963|O1|Outcome|Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir|Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care Pegylated Interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for Ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for Telaprevir 750 mg taken orally 3 times a day.
133356|NCT01821963|E1|Reported Event|Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir|Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care Pegylated Interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for Ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for Telaprevir 750 mg taken orally 3 times a day.
133357|NCT01821937|B3|Baseline|Total|Total of all reporting groups
133358|NCT01821937|B2|Baseline|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
133359|NCT01821937|B1|Baseline|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
133360|NCT01821937|P2|Participant Flow|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
133361|NCT01821937|P1|Participant Flow|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
133362|NCT01821937|O2|Outcome|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
133363|NCT01821937|O1|Outcome|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
133364|NCT01821937|O2|Outcome|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
133365|NCT01821937|O1|Outcome|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
133366|NCT01821937|O2|Outcome|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
133367|NCT01821937|O1|Outcome|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
133368|NCT01821937|O2|Outcome|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
133369|NCT01821937|O1|Outcome|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
133370|NCT01821937|O2|Outcome|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
133395|NCT01821534|O1|Outcome|All Participants|Healthy volunteers. No treatment (intervention) was administered.
157773|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter (Q4) 2010
133371|NCT01821937|O1|Outcome|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
133372|NCT01821937|O2|Outcome|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
133373|NCT01821937|O1|Outcome|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
133374|NCT01821937|E4|Reported Event|Faldaprevir 240 mg Multiple Dose|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
133375|NCT01821937|E3|Reported Event|Faldaprevir 240 mg Single Dose|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1."
133376|NCT01821937|E2|Reported Event|Faldaprevir 120 mg Multiple Dose|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
133377|NCT01821937|E1|Reported Event|Faldaprevir 120 mg Single Dose|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1."
133378|NCT01821859|B1|Baseline|Abraxane/Bevacizumab|"Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion.~Bevacizumab : Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane : Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion."
133379|NCT01821859|P1|Participant Flow|Abraxane/Bevacizumab|"Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion.~Bevacizumab : Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane : Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion."
133380|NCT01821859|O1|Outcome|Abraxane/Bevacizumab|"Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion.~Bevacizumab : Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane : Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion."
133381|NCT01821859|E1|Reported Event|Abraxane/Bevacizumab|"Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion.~Bevacizumab : Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane : Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion."
133382|NCT01821807|B3|Baseline|Total|Total of all reporting groups
133383|NCT01821807|B2|Baseline|26 Gauge Atraucan|Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
133384|NCT01821807|B1|Baseline|26 Gauge Quincke|Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
133385|NCT01821807|P2|Participant Flow|26 Gauge Atraucan|Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
133386|NCT01821807|P1|Participant Flow|26 Gauge Quincke|Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
133387|NCT01821807|O2|Outcome|26 Gauge Atraucan|Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
133388|NCT01821807|O1|Outcome|26 Gauge Quincke|Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
133389|NCT01821807|O2|Outcome|26 Gauge Atraucan|Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
133390|NCT01821807|O1|Outcome|26 Gauge Quincke|Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
133391|NCT01821807|E2|Reported Event|26 Gauge Atraucan|Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
133392|NCT01821807|E1|Reported Event|26 Gauge Quincke|Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
133393|NCT01821534|B1|Baseline|All Participants|Healthy volunteers. No treatment (intervention) was administered.
133396|NCT01821534|O1|Outcome|All Participants|Healthy volunteers. No treatment (intervention) was administered.
133397|NCT01821534|O1|Outcome|All Participants|Healthy volunteers. No treatment (intervention) was administered.
133398|NCT01821534|O1|Outcome|All Participants|Healthy volunteers. No treatment (intervention) was administered.
133399|NCT01821534|E1|Reported Event|All Participants|Healthy volunteers. No treatment (intervention) was administered.
133400|NCT01821417|B3|Baseline|Total|Total of all reporting groups
133401|NCT01821417|B2|Baseline|Dental Implant|"Randomized dental implant treatment with machined-collar implants~Dental implant treatment: Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
133402|NCT01821417|B1|Baseline|Microtextured Dental Implant|"Randomized for microtextured dental implant treatment~Microtextured dental implant treatment: Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
133403|NCT01821417|P2|Participant Flow|Dental Implant|"Randomized dental implant treatment with machined-collar implants~Dental implant treatment: Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
133404|NCT01821417|P1|Participant Flow|Microtextured Dental Implant|"Randomized for microtextured dental implant treatment~Microtextured dental implant treatment: Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
133405|NCT01821417|O2|Outcome|Dental Implant|"Randomized dental implant treatment with machined-collar implants~Dental implant treatment: Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
133406|NCT01821417|O1|Outcome|Microtextured Dental Implant|"Randomized for microtextured dental implant treatment~Microtextured dental implant treatment: Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
133407|NCT01821417|O2|Outcome|Dental Implant|"Randomized dental implant treatment with machined-collar implants~Dental implant treatment: Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
133408|NCT01821417|O1|Outcome|Microtextured Dental Implant|"Randomized for microtextured dental implant treatment~Microtextured dental implant treatment: Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
133409|NCT01821417|O2|Outcome|Dental Implant|"Randomized dental implant treatment with machined-collar implants~Dental implant treatment: Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
133410|NCT01821417|O1|Outcome|Microtextured Dental Implant|"Randomized for microtextured dental implant treatment~Microtextured dental implant treatment: Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
133411|NCT01821417|E2|Reported Event|Dental Implant|"Serious adverse events are defined as life threatening events that occur during the course of the study treatment that may or may not be related to study protocols and procedures.~Other adverse events are defined as non-life threatening events that are unexpected after the routine performance of the study protocols and procedures. These may or may not be related to the study protocols and procedures."
133412|NCT01821417|E1|Reported Event|Microtextured Dental Implant|"Serious adverse events are defined as life threatening events that occur during the course of the study treatment that may or may not be related to study protocols and procedures.~Other adverse events are defined as non-life threatening events that are unexpected after the routine performance of the study protocols and procedures. These may or may not be related to the study protocols and procedures."
133413|NCT01821378|B4|Baseline|Total|Total of all reporting groups
133414|NCT01821378|B3|Baseline|Placebo|Placebo: Once Daily
133415|NCT01821378|B2|Baseline|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
133416|NCT01821378|B1|Baseline|Lurasidone 20 mg|"Lurasidone 20 mg once daily~Lurasidone: Lurasidone 20 mg once daily"
133417|NCT01821378|P3|Participant Flow|Placebo|"Placebo Comparator 20 or 80 mg once daily~Lurasidone: Lurasidone 20 mg once daily~Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2: Lurasidone 80 mg once daily~Placebo: Once Daily"
133418|NCT01821378|P2|Participant Flow|Lurasidone 80 mg - 160 mg|"Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2~Lurasidone: Lurasidone 20 mg once daily~Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2: Lurasidone 80 mg once daily~Placebo: Once Daily"
133419|NCT01821378|P1|Participant Flow|Lurasidone 20 mg|"Lurasidone 20 mg once daily~Lurasidone: Lurasidone 20 mg once daily~Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2: Lurasidone 80 mg once daily~Placebo: Once Daily"
133420|NCT01821378|O3|Outcome|Placebo|Randomized to Placebo group at baseline
133421|NCT01821378|O2|Outcome|ENR Lurasidone 160 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 160 mg/day at week 2.
133422|NCT01821378|O1|Outcome|ENR Lurasidone 80 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 80 mg/day at week 2.
133423|NCT01821378|O3|Outcome|Placebo|Randomized to Placebo group at baseline
133424|NCT01821378|O2|Outcome|ENR Lurasidone 160 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 160 mg/day at week 2.
133425|NCT01821378|O1|Outcome|ENR Lurasidone 80 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 80 mg/day at week 2.
133426|NCT01821378|O3|Outcome|Placebo|Placebo: Once Daily
133427|NCT01821378|O2|Outcome|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
133428|NCT01821378|O1|Outcome|Lurasidone 20 mg|Lurasidone: Lurasidone 20 mg once daily
133429|NCT01821378|O2|Outcome|ENR Lurasidone 160 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 160 mg/day at week 2.
133430|NCT01821378|O1|Outcome|ENR Lurasidone 80 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 80 mg/day at week 2.
133431|NCT01821378|O3|Outcome|Placebo|Placebo: Once Daily
133432|NCT01821378|O2|Outcome|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
133433|NCT01821378|O1|Outcome|Lurasidone 20 mg|Lurasidone: Lurasidone 20 mg once daily
133434|NCT01821378|O3|Outcome|Placebo|Randomized to Placebo group at baseline
133435|NCT01821378|O2|Outcome|ENR Lurasidone 160 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 160 mg/day at week 2.
133436|NCT01821378|O1|Outcome|ENR Lurasidone 80 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 80 mg/day at week 2.
133437|NCT01821378|O2|Outcome|ENR Lurasidone 160 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 160 mg/day at week 2.
133438|NCT01821378|O1|Outcome|ENR Lurasidone 80 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 80 mg/day at week 2.
133439|NCT01821378|O3|Outcome|Placebo|Placebo: Once Daily
133440|NCT01821378|O2|Outcome|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
133441|NCT01821378|O1|Outcome|Lurasidone 20 mg|Lurasidone 20 mg once daily
133442|NCT01821378|O3|Outcome|Placebo|Placebo: Once Daily
133443|NCT01821378|O2|Outcome|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
133444|NCT01821378|O1|Outcome|Lurasidone 20 mg|Lurasidone: Lurasidone 20 mg once daily
133445|NCT01821378|O3|Outcome|Placebo|Placebo: Once Daily
133446|NCT01821378|O2|Outcome|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
133447|NCT01821378|O1|Outcome|Lurasidone 20 mg|Lurasidone 20 mg once daily
133448|NCT01821378|O3|Outcome|Placebo|Placebo: Once Daily
133449|NCT01821378|O2|Outcome|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
133450|NCT01821378|O1|Outcome|Lurasidone 20 mg|"Lurasidone 20 mg once daily~Lurasidone: Lurasidone 20 mg once daily"
133451|NCT01821378|E3|Reported Event|Placebo|Placebo: Once Daily
133452|NCT01821378|E2|Reported Event|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2 (one subject who was randomized was not treated with study drug, therefore, excluded from the safety population).
133453|NCT01821378|E1|Reported Event|Lurasidone 20 mg|Lurasidone: Lurasidone 20 mg once daily
133454|NCT01821352|B3|Baseline|Total|Total of all reporting groups
133455|NCT01821352|B2|Baseline|Placebo Laser|Placebo Laser device emitting sham green light that has no therapeutic effect.
133456|NCT01821352|B1|Baseline|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
133457|NCT01821352|P2|Participant Flow|Placebo Laser|Placebo Laser device emits sham green light that has no therapeutic effect.
133458|NCT01821352|P1|Participant Flow|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW) 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
133459|NCT01821352|O2|Outcome|Placebo Laser|Placebo Laser device emitting sham green light that has no therapeutic effect.
133460|NCT01821352|O1|Outcome|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
133461|NCT01821352|O2|Outcome|Placebo Laser|Placebo Laser device emitting sham green light that has no therapeutic effect.
133462|NCT01821352|O1|Outcome|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
133463|NCT01821352|O2|Outcome|Placebo Laser|Placebo Laser device emitting sham green light that has no therapeutic effect.
133464|NCT01821352|O1|Outcome|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
133465|NCT01821352|E2|Reported Event|Placebo Laser|Placebo Laser device emitting sham green light that has no therapeutic effect.
133466|NCT01821352|E1|Reported Event|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
133467|NCT01821326|B1|Baseline|Patients With Obscure Gastrointestinal Bleeding|
133468|NCT01821326|P1|Participant Flow|Patients With Obscure Gastrointestinal Bleeding|
133469|NCT01821326|O1|Outcome|Patients With Obscure Gastrointestinal Bleeding|
133470|NCT01821326|E1|Reported Event|Patients With Obscure Gastrointestinal Bleeding|
133471|NCT01821118|B3|Baseline|Total|Total of all reporting groups
133472|NCT01821118|B2|Baseline|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
133473|NCT01821118|B1|Baseline|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
134352|NCT01815099|O2|Outcome|Post rTMS Treatment|Assessment After Completing rTMS
133474|NCT01821118|P2|Participant Flow|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
133475|NCT01821118|P1|Participant Flow|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
133476|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
133477|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
133478|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
133479|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
133480|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
133481|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
133482|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
133483|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
133484|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
133485|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
133486|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
133487|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
133488|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
133489|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
133490|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
133491|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
133492|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
133493|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
133494|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
133495|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
133496|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
133497|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
133856|NCT01818414|B2|Baseline|Folic Acid|"Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S~Folic Acid"
133498|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
133499|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
133500|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
133501|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
133502|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
133503|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
133504|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
133505|NCT01821118|E2|Reported Event|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
133506|NCT01821118|E1|Reported Event|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
133507|NCT01821105|B1|Baseline|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.~PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).~CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.~fludeoxyglucose F 18: Given IV~computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
133508|NCT01821105|P1|Participant Flow|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.~PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).~CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.~fludeoxyglucose F 18: Given IV~computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
133509|NCT01821105|O1|Outcome|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.~PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).~CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.~fludeoxyglucose F 18: Given IV~computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
133510|NCT01821105|O1|Outcome|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.~PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).~CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.~fludeoxyglucose F 18: Given IV~computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
133511|NCT01821105|O1|Outcome|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.~PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).~CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.~fludeoxyglucose F 18: Given IV~computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
133512|NCT01821105|E1|Reported Event|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.~PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).~CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.~fludeoxyglucose F 18: Given IV~computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
133513|NCT01820754|B1|Baseline|Ipilimumab|"Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses~Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes~Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)~Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses~Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)~Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin"
133528|NCT01820585|P2|Participant Flow|ESL 400 mg|Eslicarbazepine acetate (ESL) 400 mg : ESL was supplied in 400-mg tablets and was administered QD by oral route.
133514|NCT01820754|P1|Participant Flow|Ipilimumab|"Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses~Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes~Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)~Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses~Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin Area Under Curve (AUC) 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)~Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin"
133515|NCT01820754|O1|Outcome|Ipilimumab|"Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses~Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes~Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)~Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses~Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)~Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin"
133516|NCT01820754|O1|Outcome|Ipilimumab|"Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses~Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes~Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)~Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses~Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)~Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin"
133517|NCT01820754|O1|Outcome|Ipilimumab|"Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses~Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes~Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)~Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses~Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)~Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin"
133518|NCT01820754|O1|Outcome|Ipilimumab|"Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses~Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes~Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)~Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses~Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)~Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin"
133519|NCT01820754|O1|Outcome|Ipilimumab|"Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses~Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes~Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)~Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses~Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)~Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin"
133520|NCT01820754|E1|Reported Event|Ipilimumab|"Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses~Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes~Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)~Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses~Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)~Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin"
133521|NCT01820585|B5|Baseline|Total|Total of all reporting groups
133522|NCT01820585|B4|Baseline|ESL 1200 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 1200 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
133523|NCT01820585|B3|Baseline|ESL 800 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 800 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
133524|NCT01820585|B2|Baseline|ESL 400 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 400 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
133525|NCT01820585|B1|Baseline|Placebo|"Tablets~Placebo : Tablets"
133526|NCT01820585|P4|Participant Flow|ESL 1200 mg|ESL was supplied in 400-mg and 600-mg tablets and was administered QD by oral route.
133527|NCT01820585|P3|Participant Flow|ESL 800 mg|ESL 800 mg : ESL was supplied in 400-mg tablets and was administered QD by oral route
133953|NCT01817855|O3|Outcome|AZD7624 COPD Cohort 6|COPD patients on Cohort 6 with 966 µg delivered dose of AZD7624, once daily
133529|NCT01820585|P1|Participant Flow|Placebo|Placebo tablets matching the 400-mg and 600-mg tablets were administered Once daily (QD) by oral route.
133530|NCT01820585|O4|Outcome|ESL 1200 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 1200 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
133531|NCT01820585|O3|Outcome|ESL 800 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 800 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
133532|NCT01820585|O2|Outcome|ESL 400 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 400 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
133533|NCT01820585|O1|Outcome|Placebo|"Tablets~Placebo : Tablets"
133534|NCT01820585|E4|Reported Event|ESL 1200 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 1200 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
133535|NCT01820585|E3|Reported Event|ESL 800 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 800 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
133536|NCT01820585|E2|Reported Event|ESL 400 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 400 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
133537|NCT01820585|E1|Reported Event|Placebo|"Tablets~Placebo : Tablets"
133538|NCT01820559|B4|Baseline|Total|Total of all reporting groups
133539|NCT01820559|B3|Baseline|ESL 1200 mg|"eslicarbazepine acetate 1200 mg~ESL 1200 mg :"
133540|NCT01820559|B2|Baseline|ESL 800 mg|"eslicarbazepine acetate 800 mg~ESL 800 mg :"
133541|NCT01820559|B1|Baseline|Placebo|"Placebo tablets~Placebo : Tablets"
133542|NCT01820559|P3|Participant Flow|ESL 1200 mg|"eslicarbazepine acetate 1200 mg~ESL 1200 mg :"
133543|NCT01820559|P2|Participant Flow|ESL 800 mg|"eslicarbazepine acetate 800 mg~ESL 800 mg :"
133544|NCT01820559|P1|Participant Flow|Placebo|"Placebo tablets~Placebo : Tablets"
133545|NCT01820559|O3|Outcome|ESL 1200 mg|"eslicarbazepine acetate 1200 mg~ESL 1200 mg :"
133546|NCT01820559|O2|Outcome|ESL 800 mg|"eslicarbazepine acetate 800 mg~ESL 800 mg :"
133547|NCT01820559|O1|Outcome|Placebo|"Placebo tablets~Placebo : Tablets"
133548|NCT01820559|E3|Reported Event|ESL 1200 mg|"eslicarbazepine acetate 1200 mg~ESL 1200 mg :"
133549|NCT01820559|E2|Reported Event|ESL 800 mg|"eslicarbazepine acetate 800 mg~ESL 800 mg :"
133550|NCT01820559|E1|Reported Event|Placebo|"Placebo tablets~Placebo : Tablets"
133551|NCT01820416|B4|Baseline|Total|Total of all reporting groups
133552|NCT01820416|B3|Baseline|Control|Visit laboratory using same schedule as experiment and placebo. No Low-level laser or any treatment applied. Used to assess normal test-retest variability.
133553|NCT01820416|B2|Baseline|Disabled Laser|Low-level laser device with laser diodes disabled. Also applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.
133554|NCT01820416|B1|Baseline|Low-Level Laser Therapy|"Low-level laser applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.~Low-level Laser Therapy: Portable unit containing two laser diodes producing 532 and 635 nm wavelengths. Both diodes produced energy levels of 7.5 mw (class IIIb). Beams from both diodes were dispersed through lenses to create parallel line-generated beams, rather than spots. The 532 nm light was constant, and the 635 nm light was pulsed, with frequencies of 15 and 33 Hz. The pulsing alternated between frequencies every 30 seconds."
133555|NCT01820416|P3|Participant Flow|Control|Visit laboratory using same schedule as experiment and placebo. No Low-level laser or any treatment applied. Used to assess normal test-retest variability.
133556|NCT01820416|P2|Participant Flow|Disabled Laser|"Low-level laser device with laser diodes disabled. Also applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.~Placebo Comparator: Disabled Laser: Portable unit containing two DISABLED laser diodes. Same protocol was followed as for the Experimental (radiation) group, except that the disabled diodes produced no radiation."
133557|NCT01820416|P1|Participant Flow|Low-Level Laser Therapy|"Low-level laser applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.~Low-level Laser Therapy: Portable unit containing two laser diodes producing 532 and 635 nm wavelengths. Both diodes produced energy levels of 7.5 mw (class IIIb). Beams from both diodes were dispersed through lenses to create parallel line-generated beams, rather than spots. The 532 nm light was constant, and the 635 nm light was pulsed, with frequencies of 15 and 33 Hz. The pulsing alternated between frequencies every 30 seconds."
133558|NCT01820416|O3|Outcome|Control|Visit laboratory using same schedule as experiment and placebo. No Low-level laser or any treatment applied. Used to assess normal test-retest variability.
133559|NCT01820416|O2|Outcome|Disabled Laser|"Low-level laser device with laser diodes disabled. Also applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.~Placebo Comparator: Disabled Laser: Portable unit containing two DISABLED laser diodes. Same protocol was followed as for the Experimental (radiation) group, except that the disabled diodes produced no radiation."
133560|NCT01820416|O1|Outcome|Low-Level Laser Therapy|"Low-level laser applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.~Low-level Laser Therapy: Portable unit containing two laser diodes producing 532 and 635 nm wavelengths. Both diodes produced energy levels of 7.5 mw (class IIIb). Beams from both diodes were dispersed through lenses to create parallel line-generated beams, rather than spots. The 532 nm light was constant, and the 635 nm light was pulsed, with frequencies of 15 and 33 Hz. The pulsing alternated between frequencies every 30 seconds."
133561|NCT01820416|E3|Reported Event|Control|Visit laboratory using same schedule as experiment and placebo. No Low-level laser or any treatment applied. Used to assess normal test-retest variability.
133562|NCT01820416|E2|Reported Event|Disabled Laser|Low-level laser device with laser diodes disabled. Also applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.
133563|NCT01820416|E1|Reported Event|Low-Level Laser Therapy|"Low-level laser applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.~Low-level Laser Therapy: Portable unit containing two laser diodes producing 532 and 635 nm wavelengths. Both diodes produced energy levels of 7.5 mw (class IIIb). Beams from both diodes were dispersed through lenses to create parallel line-generated beams, rather than spots. The 532 nm light was constant, and the 635 nm light was pulsed, with frequencies of 15 and 33 Hz. The pulsing alternated between frequencies every 30 seconds."
133564|NCT01820364|B1|Baseline|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
133565|NCT01820364|P2|Participant Flow|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
133566|NCT01820364|P1|Participant Flow|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
133567|NCT01820364|O2|Outcome|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
133568|NCT01820364|O1|Outcome|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
133569|NCT01820364|O1|Outcome|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
133570|NCT01820364|O1|Outcome|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
133571|NCT01820364|O2|Outcome|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
133572|NCT01820364|O1|Outcome|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
133573|NCT01820364|O1|Outcome|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
133574|NCT01820364|O2|Outcome|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
133575|NCT01820364|O1|Outcome|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
133576|NCT01820364|E1|Reported Event|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
133577|NCT01819935|B3|Baseline|Total|Total of all reporting groups
133578|NCT01819935|B2|Baseline|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
133579|NCT01819935|B1|Baseline|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
133580|NCT01819935|P2|Participant Flow|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
133581|NCT01819935|P1|Participant Flow|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
133582|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
133583|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
133584|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
133585|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
133586|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
133587|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
133588|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
133589|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
133590|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
133591|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
133592|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
133593|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
133594|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
133595|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
133596|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
133597|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
133598|NCT01819935|E2|Reported Event|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
133599|NCT01819935|E1|Reported Event|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
133600|NCT01819922|B1|Baseline|Overall Participants|All randomized participants who received single dose of PF-05175157 600 mg capsule or single dose of placebo matched to PF-05175157 600 mg capsule in either first or second intervention period.
133601|NCT01819922|P2|Participant Flow|Placebo Then PF-05175157|Participants who met the pre-defined CPET criteria, received single dose of placebo matched to PF-05175157, 600 mg capsule orally in first intervention period then single dose of PF-05175157 600 mg capsule orally in second intervention period. A washout period at least of 7-10 days was maintained between each intervention period.
133602|NCT01819922|P1|Participant Flow|PF-05175157 Then Placebo|Participants who met the pre-defined cardiopulmonary exercise test (CPET) criteria, received single dose of PF-05175157 600 milligram (mg) capsule orally in first intervention period then single dose of placebo matched to PF-05175157 capsule, 600 mg orally in second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133603|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133604|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133605|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133606|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133607|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133608|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133609|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133610|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133611|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133612|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133613|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133614|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133615|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133616|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133617|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133618|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133619|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133620|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133621|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133622|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133623|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133624|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133625|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133626|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133627|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133628|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133629|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133630|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133631|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133632|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133633|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133634|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133705|NCT01819415|P2|Participant Flow|Group 2 - Anti-VEGF Plus AREDS-1 Supplementation.|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
133635|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133636|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133637|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133638|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133639|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133640|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133641|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133642|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133643|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133644|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133645|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133646|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133647|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133648|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133649|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133650|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133651|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133652|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133653|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133654|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133655|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133656|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133657|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133658|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133706|NCT01819415|P1|Participant Flow|Group 3 - Naive|Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.
133659|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133660|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133661|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133662|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133663|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133664|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133665|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133666|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133667|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133668|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133669|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133670|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133671|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133672|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133673|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133674|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133675|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133676|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133677|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133678|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133679|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133680|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133681|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133682|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133707|NCT01819415|O4|Outcome|Group 4 - Control|Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.
133683|NCT01819922|E2|Reported Event|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133684|NCT01819922|E1|Reported Event|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
133685|NCT01819844|B1|Baseline|Closed-loop Blood Glucose Control|
133686|NCT01819844|P1|Participant Flow|Closed-loop Blood Glucose Control|"Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg.~Closed-loop blood glucose control: The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose > 2 u/kg)."
133687|NCT01819844|O1|Outcome|Closed-loop Blood Glucose Control|"Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg.~Closed-loop blood glucose control: The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose > 2 u/kg)."
133688|NCT01819844|O1|Outcome|Closed-loop Blood Glucose Control|"Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg.~Closed-loop blood glucose control: The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose > 2 u/kg)."
133689|NCT01819844|O1|Outcome|Closed-loop Blood Glucose Control|"Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg.~Closed-loop blood glucose control: The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose > 2 u/kg)."
133690|NCT01819844|O1|Outcome|Closed-loop Blood Glucose Control|"Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg.~Closed-loop blood glucose control: The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose > 2 u/kg)."
133691|NCT01819844|O1|Outcome|Closed-loop Blood Glucose Control|"Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg.~Closed-loop blood glucose control: The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose > 2 u/kg)."
133692|NCT01819844|O1|Outcome|Closed-loop Blood Glucose Control|"Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg.~Closed-loop blood glucose control: The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose > 2 u/kg)."
133693|NCT01819844|O1|Outcome|Closed-loop Blood Glucose Control|
133694|NCT01819844|O1|Outcome|Closed-loop Blood Glucose Control|
133695|NCT01819844|O1|Outcome|Closed-loop Blood Glucose Control|"Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg.~Closed-loop blood glucose control: The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose > 2 u/kg)."
133696|NCT01819844|O1|Outcome|Closed-loop Blood Glucose Control|
133697|NCT01819844|E1|Reported Event|Closed-loop Blood Glucose Control|
133698|NCT01819415|B5|Baseline|Total|Total of all reporting groups
133699|NCT01819415|B4|Baseline|Group 4 - Control|Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.
133700|NCT01819415|B3|Baseline|Group 1 - Anti-VEGF Plus AREDS-2|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).
133701|NCT01819415|B2|Baseline|Group 2 - Anti-VEGF Plus AREDS-1 Supplementation.|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
133702|NCT01819415|B1|Baseline|Group 3 - Naive|Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.
133703|NCT01819415|P4|Participant Flow|Group 4 - Control|Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.
133704|NCT01819415|P3|Participant Flow|Group 1 - Anti-VEGF Plus AREDS-2|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).
133708|NCT01819415|O3|Outcome|Group 1 - Anti-VEGF Plus AREDS-2|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).
133709|NCT01819415|O2|Outcome|Group 2 - Anti-VEGF Plus AREDS-1 Supplementation.|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
133710|NCT01819415|O1|Outcome|Group 3 - Naive|Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.
133711|NCT01819415|E4|Reported Event|Group 4 - Control|Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.
133712|NCT01819415|E3|Reported Event|Group 1 - Anti-VEGF Plus AREDS-2|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).
133713|NCT01819415|E2|Reported Event|Group 2 - Anti-VEGF Plus AREDS-1 Supplementation.|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
133714|NCT01819415|E1|Reported Event|Group 3 - Naive|Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.
133715|NCT01819311|B3|Baseline|Total|Total of all reporting groups
133716|NCT01819311|B2|Baseline|Placebo Attention Task|"The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.~Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability."
133717|NCT01819311|B1|Baseline|Attention Bias Modification|"Attention Bias Modification is a computer-based attention training program~Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders."
133718|NCT01819311|P2|Participant Flow|Placebo Attention Task|"The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.~Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability."
133719|NCT01819311|P1|Participant Flow|Attention Bias Modification|"Attention Bias Modification is a computer-based attention training program~Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders."
133720|NCT01819311|O2|Outcome|Placebo Attention Task|"The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.~Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability."
133721|NCT01819311|O1|Outcome|Attention Bias Modification|"Attention Bias Modification is a computer-based attention training program~Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders."
133722|NCT01819311|O2|Outcome|Placebo Attention Task|"The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.~Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability."
133723|NCT01819311|O1|Outcome|Attention Bias Modification|"Attention Bias Modification is a computer-based attention training program~Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders."
133724|NCT01819311|O2|Outcome|Placebo Attention Task|"The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.~Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability."
133747|NCT01819272|O6|Outcome|2000 mg XR|"2000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
133748|NCT01819272|O5|Outcome|1000 mg XR|"1000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
133749|NCT01819272|O4|Outcome|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
134353|NCT01815099|O1|Outcome|Pre rTMS Treatment|Assessment before beginning rTMS treatment
133725|NCT01819311|O1|Outcome|Attention Bias Modification|"Attention Bias Modification is a computer-based attention training program~Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders."
133726|NCT01819311|O2|Outcome|Placebo Attention Task|"The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.~Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability."
133727|NCT01819311|O1|Outcome|Attention Bias Modification|"Attention Bias Modification is a computer-based attention training program~Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders."
133728|NCT01819311|O2|Outcome|Placebo Attention Task|"The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.~Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability."
133729|NCT01819311|O1|Outcome|Attention Bias Modification|"Attention Bias Modification is a computer-based attention training program~Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders."
133730|NCT01819311|O2|Outcome|Placebo Attention Task|"The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.~Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability."
133731|NCT01819311|O1|Outcome|Attention Bias Modification|"Attention Bias Modification is a computer-based attention training program~Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders."
133732|NCT01819311|E2|Reported Event|Placebo Attention Task|"The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.~Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability."
133733|NCT01819311|E1|Reported Event|Attention Bias Modification|"Attention Bias Modification is a computer-based attention training program~Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders."
133734|NCT01819272|B7|Baseline|Total|Total of all reporting groups
133735|NCT01819272|B6|Baseline|2000 mg XR|"2000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
133736|NCT01819272|B5|Baseline|1000 mg XR|"1000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
133737|NCT01819272|B4|Baseline|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
133738|NCT01819272|B3|Baseline|800 mg DR|"800 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
133739|NCT01819272|B2|Baseline|600 mg DR|"600 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
133740|NCT01819272|B1|Baseline|Placebo|Placebo once daily in the morning
133741|NCT01819272|P6|Participant Flow|2000 mg XR|"2000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
133742|NCT01819272|P5|Participant Flow|1000 mg XR|"1000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
133743|NCT01819272|P4|Participant Flow|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
133744|NCT01819272|P3|Participant Flow|800 mg DR|"800 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
133745|NCT01819272|P2|Participant Flow|600 mg DR|"600 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
133746|NCT01819272|P1|Participant Flow|Placebo|Placebo once daily in the morning
135301|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
133750|NCT01819272|O3|Outcome|800 mg DR|"800 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
133751|NCT01819272|O2|Outcome|600 mg DR|"600 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
133752|NCT01819272|O1|Outcome|Placebo|Placebo once daily in the morning
133753|NCT01819272|O6|Outcome|2000 mg XR|"2000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
133754|NCT01819272|O5|Outcome|1000 mg XR|"1000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
133755|NCT01819272|O4|Outcome|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
133756|NCT01819272|O3|Outcome|800 mg DR|"800 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
133757|NCT01819272|O2|Outcome|600 mg DR|"600 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
133758|NCT01819272|O1|Outcome|Placebo|Placebo once daily in the morning
133759|NCT01819272|O6|Outcome|2000 mg XR|"2000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
133760|NCT01819272|O5|Outcome|1000 mg XR|"1000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
133761|NCT01819272|O4|Outcome|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
133762|NCT01819272|O3|Outcome|800 mg DR|"800 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
133763|NCT01819272|O2|Outcome|600 mg DR|"600 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
133764|NCT01819272|O1|Outcome|Placebo|Placebo once daily in the morning
133765|NCT01819272|E6|Reported Event|2000 mg XR|"2000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
133766|NCT01819272|E5|Reported Event|1000 mg XR|"1000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
133767|NCT01819272|E4|Reported Event|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
133768|NCT01819272|E3|Reported Event|800 mg DR|"800 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
133769|NCT01819272|E2|Reported Event|600 mg DR|"600 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
133770|NCT01819272|E1|Reported Event|Placebo|Placebo once daily in the morning
133771|NCT01819194|B1|Baseline|Dispensed Subjects|All subjects that were dispensed the study lens.
133772|NCT01819194|P1|Participant Flow|Overall|Subjects only wore one lens: senofilcon A, 38% water. Subjects, were enrolled and screened per inclusion/exclusion criteria.
133773|NCT01819194|O1|Outcome|Senofilcon A, 38% Water|Senofilcon A, 38% water
133774|NCT01819194|O1|Outcome|Senofilcon A, 38% Water|Senofilcon A, 38% water
133775|NCT01819194|E1|Reported Event|Senofilcon A, 38% Water|Senofilcon A, 38% water
133776|NCT01819129|B3|Baseline|Total|Total of all reporting groups
133777|NCT01819129|B2|Baseline|NovoRapid|At randomization, all subjects started on 4 units of mealtime NovoRapid®/NovoLog® (insulin aspart; bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regimen. NovoRapid®/ NovoLog® was administered (sc) 0-2 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
133778|NCT01819129|B1|Baseline|Faster Aspart|At randomization, all subjects started on 4 units of mealtime faster aspart (bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regiment. Faster aspart was administered (sc) 0-2 minutes before each main meal and dose was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
133779|NCT01819129|P2|Participant Flow|NovoRapid|At randomization, all subjects started on 4 units of mealtime NovoRapid®/NovoLog® (insulin aspart; bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regimen. NovoRapid®/ NovoLog® was administered (sc) 0-2 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
133780|NCT01819129|P1|Participant Flow|Faster Aspart|At randomization, all subjects started on 4 units of mealtime faster aspart (bolus insulin) in combination with once-daily subcutaneous (sc) injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regiment. Faster aspart was administered (sc) 0-2 minutes before each main meal and dose was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime self-measured plasma glucose (SMPG) on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
133852|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
134075|NCT01816893|E1|Reported Event|Euglycemic Clamp|Participant undergoes a euglycemic hyperinsulinemic clamp
133781|NCT01819129|O2|Outcome|NovoRapid|At randomization, all subjects started on 4 units of mealtime NovoRapid®/NovoLog® (insulin aspart; bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regimen. NovoRapid®/ NovoLog® was administered (sc) 0-2 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
133782|NCT01819129|O1|Outcome|Faster Aspart|At randomization, all subjects started on 4 units of mealtime faster aspart (bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regiment. Faster aspart was administered (sc) 0-2 minutes before each main meal and dose was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
133783|NCT01819129|O2|Outcome|NovoRapid|At randomization, all subjects started on 4 units of mealtime NovoRapid®/NovoLog® (insulin aspart; bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regimen. NovoRapid®/ NovoLog® was administered (sc) 0-2 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
133784|NCT01819129|O1|Outcome|Faster Aspart|At randomization, all subjects started on 4 units of mealtime faster aspart (bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regiment. Faster aspart was administered (sc) 0-2 minutes before each main meal and dose was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
133785|NCT01819129|O2|Outcome|NovoRapid|At randomization, all subjects started on 4 units of mealtime NovoRapid®/NovoLog® (insulin aspart; bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regimen. NovoRapid®/ NovoLog® was administered (sc) 0-2 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
133786|NCT01819129|O1|Outcome|Faster Aspart|At randomization, all subjects started on 4 units of mealtime faster aspart (bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regiment. Faster aspart was administered (sc) 0-2 minutes before each main meal and dose was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
133787|NCT01819129|O2|Outcome|NovoRapid|At randomization, all subjects started on 4 units of mealtime NovoRapid®/NovoLog® (insulin aspart; bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regimen. NovoRapid®/ NovoLog® was administered (sc) 0-2 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
133788|NCT01819129|O1|Outcome|Faster Aspart|At randomization, all subjects started on 4 units of mealtime faster aspart (bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regiment. Faster aspart was administered (sc) 0-2 minutes before each main meal and dose was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
133789|NCT01819129|E2|Reported Event|NovoRapid|At randomization, all subjects started on 4 units of mealtime NovoRapid®/NovoLog® (insulin aspart; bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regimen. NovoRapid®/ NovoLog® was administered (sc) 0-2 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
134076|NCT01816776|B3|Baseline|Total|Total of all reporting groups
133790|NCT01819129|E1|Reported Event|Faster Aspart|At randomization, all subjects started on 4 units of mealtime faster aspart (bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regiment. Faster aspart was administered (sc) 0-2 minutes before each main meal and dose was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
133791|NCT01818752|B3|Baseline|Total|Total of all reporting groups
133792|NCT01818752|B2|Baseline|Carfilzomib, Melphalan, Prednisone|Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
133793|NCT01818752|B1|Baseline|Bortezomib, Melphalan, Prednisone|Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
133794|NCT01818752|P2|Participant Flow|Carfilzomib, Melphalan, Prednisone|Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
133795|NCT01818752|P1|Participant Flow|Bortezomib, Melphalan, Prednisone|Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
133796|NCT01818752|O2|Outcome|Carfilzomib, Melphalan, Prednisone|Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
133797|NCT01818752|O1|Outcome|Bortezomib, Melphalan, Prednisone|Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
133798|NCT01818752|O2|Outcome|Carfilzomib, Melphalan, Prednisone|Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
133799|NCT01818752|O1|Outcome|Bortezomib, Melphalan, Prednisone|Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
133800|NCT01818752|O2|Outcome|Carfilzomib, Melphalan, Prednisone|Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
133801|NCT01818752|O1|Outcome|Bortezomib, Melphalan, Prednisone|Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
133802|NCT01818752|O2|Outcome|Carfilzomib, Melphalan, Prednisone|Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
133803|NCT01818752|O1|Outcome|Bortezomib, Melphalan, Prednisone|Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
133804|NCT01818752|O2|Outcome|Carfilzomib, Melphalan, Prednisone|Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
133853|NCT01818596|E2|Reported Event|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in antiretroviral treatment (ART)-naive participants
157774|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
133805|NCT01818752|O1|Outcome|Bortezomib, Melphalan, Prednisone|Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
133806|NCT01818752|O2|Outcome|Carfilzomib, Melphalan, Prednisone|Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
133807|NCT01818752|O1|Outcome|Bortezomib, Melphalan, Prednisone|Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
133808|NCT01818752|O2|Outcome|Carfilzomib, Melphalan, Prednisone|Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
133809|NCT01818752|O1|Outcome|Bortezomib, Melphalan, Prednisone|Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
133810|NCT01818752|E2|Reported Event|Carfilzomib, Melphalan, Prednisone|Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
133811|NCT01818752|E1|Reported Event|Bortezomib, Melphalan, Prednisone|Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
133812|NCT01818700|B1|Baseline|Norspan Patch (Buprenorphine)|"Trade name is Norspan. Buprenorphine 5μg/h, 10 μg/h, 20 μg/h patches will be used (4 patches a box). Patch will be administered every 7th day.~Buprenorphine: 8weeks treatment with Norspan®(Buprenorphine)"
133813|NCT01818700|P1|Participant Flow|Single Arm - Norspan Patch (Buprenorphine)|This study is single arm for Norspan(buprenorphine) patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
133814|NCT01818700|O1|Outcome|Single Arm - Norspan Patch (Buprenorphine)|This study is single arm for Norspan(buprenorphine) patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
133815|NCT01818700|O1|Outcome|Single Arm - Norspan Patch (Buprenorphine)|This study is single arm for Norspan(buprenorphine) patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
133816|NCT01818700|O1|Outcome|Single Arm - Norspan Patch (Buprenorphine)|This study is single arm for Norspan(buprenorphine) patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
133817|NCT01818700|O1|Outcome|Single Arm - Norspan Patch (Buprenorphine)|This study is single arm for Norspan(buprenorphine) patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
133854|NCT01818596|E1|Reported Event|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in antiretroviral treatment (ART)-experienced participants
133818|NCT01818700|O1|Outcome|Single Arm-Norspan Patch (Buprenorphine)|"This trial is single arm with Norspan patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).~Buprenorphine: 8weeks treatment with Norspan®(Buprenorphine)"
133819|NCT01818700|O1|Outcome|Single Arm-Norspan Patch (Buprenorphine)|This study is single study with buprenorphine. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
133820|NCT01818700|E1|Reported Event|Norspan Patch (Buprenorphine)|"Trade name is Norspan. Buprenorphine 5μg/h, 10 μg/h, 20 μg/h patches will be used (4 patches a box). Patch will be administered every 7th day.~Buprenorphine: 8weeks treatment with Norspan®(Buprenorphine)"
133821|NCT01818596|B3|Baseline|Total|Total of all reporting groups
133822|NCT01818596|B2|Baseline|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
133823|NCT01818596|B1|Baseline|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
133824|NCT01818596|P2|Participant Flow|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
133825|NCT01818596|P1|Participant Flow|Cohort 1 (Treatment-experienced)|Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet administered orally once daily with food for 144 weeks in antiretroviral treatment (ART)-experienced participants
133826|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
133827|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
133828|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
133829|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
133830|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
133831|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
133832|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
133833|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
133834|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
133835|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
133836|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
133837|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
133838|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
133839|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
133840|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
133841|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
133842|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
133843|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
133844|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
133845|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
133846|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
133847|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
133848|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
133849|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
133850|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
133851|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
133857|NCT01818414|B1|Baseline|Misoprostol|"Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.~Misoprostol"
133858|NCT01818414|P2|Participant Flow|Folic Acid|"Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S~Folic Acid"
133859|NCT01818414|P1|Participant Flow|Misoprostol|"Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.~Misoprostol"
133860|NCT01818414|O2|Outcome|Folic Acid|"Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S~Folic Acid"
133861|NCT01818414|O1|Outcome|Misoprostol|"Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.~Misoprostol"
133862|NCT01818414|O2|Outcome|Folic Acid|Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S
133863|NCT01818414|O1|Outcome|Misoprostol|Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.
133864|NCT01818414|O2|Outcome|Folic Acid|"Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S~Folic Acid"
133865|NCT01818414|O1|Outcome|Misoprostol|"Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.~Misoprostol"
133866|NCT01818414|O2|Outcome|Folic Acid|Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S
133867|NCT01818414|O1|Outcome|Misoprostol|Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.
133868|NCT01818414|O2|Outcome|Folic Acid|"Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S~Folic Acid"
133869|NCT01818414|O1|Outcome|Misoprostol|"Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.~Misoprostol"
133870|NCT01818414|E2|Reported Event|Placebo Comparator: Folic Acid|Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S
133871|NCT01818414|E1|Reported Event|Misoprostol|Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S
133872|NCT01818336|B1|Baseline|Safety Population|All subjects who had skin testing performed (i.e., administered any component of the Penicillin Skin Test Kit).
133873|NCT01818336|P2|Participant Flow|Subjects in Retest Population|All subjects who initially tested positive to any of the initial skin tests with penicillin reagents and subsequently returned after 4 weeks for retesting.
133874|NCT01818336|P1|Participant Flow|Intent-to-Treat Population|All subjects who had valid skin testing performed (i.e., administered all components of the Penicillin Skin Test Kit and the histamine and control results were valid) and who received the oral amoxicillin challenge.
133875|NCT01818336|O1|Outcome|Intent-to-Treat Population|All subjects who had valid skin testing performed (i.e., administered all components of the Penicillin Skin Test Kit and the histamine control results are valid) and who receive the oral amoxicillin challenge.
133876|NCT01818336|E3|Reported Event|Subjects With AE Related to Oral Amox Challenge|"Intervention: Penicillin skin test kit~The skin test procedure first involved puncture testing. Subjects who had negative skin puncture test results to any of the drug antigens contained within the Penicillin Skin Test Kit then underwent intradermal testing in duplicate. Subjects who had any positive skin test to drug antigens in the Penicillin Skin Test Kit were asked to return in 4 weeks to confirm the positive test(s). Subjects who had negative puncture and intradermal test results were given the oral amoxicillin challenge, which was comprised of a single, age-dependent, full oral dose of amoxicillin. The purpose of the oral amoxicillin challenge was to confirm absence of allergy and confirm the NPV of skin testing. Subjects were monitored at the study site for 1 hour following oral amoxicillin challenge and then sent home. The study site followed up by telephone with all subjects ≥72 hours after administration of the oral amoxicillin challenge."
133877|NCT01818336|E2|Reported Event|Subjects With AE Related to Skin Testing|"Intervention: Penicillin skin test kit~The skin test procedure first involved puncture testing. Subjects who had negative skin puncture test results to any of the drug antigens contained within the Penicillin Skin Test Kit then underwent intradermal testing in duplicate. Subjects who had any positive skin test to drug antigens in the Penicillin Skin Test Kit were asked to return in 4 weeks to confirm the positive test(s)."
133878|NCT01818336|E1|Reported Event|Safety Population-All Study-Emergent Adverse Events|"Intervention: Penicillin skin test kit~The skin test procedure first involved puncture testing. Subjects who had negative skin puncture test results to any of the drug antigens contained within the Penicillin Skin Test Kit then underwent intradermal testing in duplicate. Subjects who had any positive skin test to drug antigens in the Penicillin Skin Test Kit were asked to return in 4 weeks to confirm the positive test(s). Subjects who had negative puncture and intradermal test results were given the oral amoxicillin challenge, which was comprised of a single, age-dependent, full oral dose of amoxicillin. The purpose of the oral amoxicillin challenge was to confirm absence of allergy and confirm the NPV of skin testing. Subjects were monitored at the study site for 1 hour following oral amoxicillin challenge and then sent home. The study site followed up by telephone with all subjects ≥72 hours after administration of the oral amoxicillin challenge."
133879|NCT01818297|B3|Baseline|Total|Total of all reporting groups
133880|NCT01818297|B2|Baseline|Control|"Control settings of Medtronic PrimeAdvanced® neurostimulator system implant~PrimeAdvanced® neurostimulator system: Neurostimulator and associated components"
133881|NCT01818297|B1|Baseline|Treatment|"Treatment settings of Medtronic PrimeAdvanced® neurostimulator system implant~PrimeAdvanced® neurostimulator system: Neurostimulator and associated components"
133882|NCT01818297|P2|Participant Flow|Control|"Control settings of Medtronic PrimeAdvanced® neurostimulator system implant~PrimeAdvanced® neurostimulator system: Neurostimulator and associated components"
133883|NCT01818297|P1|Participant Flow|Treatment|"Treatment settings of Medtronic PrimeAdvanced® neurostimulator system implant~PrimeAdvanced® neurostimulator system: Neurostimulator and associated components"
133884|NCT01818297|O2|Outcome|Control|"Control settings of Medtronic PrimeAdvanced® neurostimulator system implant~PrimeAdvanced® neurostimulator system: Neurostimulator and associated components"
133885|NCT01818297|O1|Outcome|Treatment|"Treatment settings of Medtronic PrimeAdvanced® neurostimulator system implant~PrimeAdvanced® neurostimulator system: Neurostimulator and associated components"
133886|NCT01818297|O2|Outcome|Control|"Control settings of Medtronic PrimeAdvanced® neurostimulator system implant~PrimeAdvanced® neurostimulator system: Neurostimulator and associated components"
133952|NCT01817855|O4|Outcome|AZD7624 Healthy Volunteers Cohort 1|Healthy volunteers on Cohort 1 with 261 µg delivered dose of AZD7624, twice daily
133887|NCT01818297|O1|Outcome|Treatment|"Treatment settings of Medtronic PrimeAdvanced® neurostimulator system implant~PrimeAdvanced® neurostimulator system: Neurostimulator and associated components"
133888|NCT01818297|O2|Outcome|Control|"Control settings of Medtronic PrimeAdvanced® neurostimulator system implant~PrimeAdvanced® neurostimulator system: Neurostimulator and associated components"
133889|NCT01818297|O1|Outcome|Treatment|"Treatment settings of Medtronic PrimeAdvanced® neurostimulator system implant~PrimeAdvanced® neurostimulator system: Neurostimulator and associated components"
133890|NCT01818297|O2|Outcome|Control|"Control settings of Medtronic PrimeAdvanced® neurostimulator system implant~PrimeAdvanced® neurostimulator system: Neurostimulator and associated components"
133891|NCT01818297|O1|Outcome|Treatment|"Treatment settings of Medtronic PrimeAdvanced® neurostimulator system implant~PrimeAdvanced® neurostimulator system: Neurostimulator and associated components"
133892|NCT01818297|O2|Outcome|Control|"Control settings of Medtronic PrimeAdvanced® neurostimulator system implant~PrimeAdvanced® neurostimulator system: Neurostimulator and associated components"
133893|NCT01818297|O1|Outcome|Treatment|"Treatment settings of Medtronic PrimeAdvanced® neurostimulator system implant~PrimeAdvanced® neurostimulator system: Neurostimulator and associated components"
133894|NCT01818297|O2|Outcome|Control|"Control settings of Medtronic PrimeAdvanced® neurostimulator system implant~PrimeAdvanced® neurostimulator system: Neurostimulator and associated components"
133895|NCT01818297|O1|Outcome|Treatment|"Treatment settings of Medtronic PrimeAdvanced® neurostimulator system implant~PrimeAdvanced® neurostimulator system: Neurostimulator and associated components"
133896|NCT01818297|E2|Reported Event|Control|"Control settings of Medtronic PrimeAdvanced® neurostimulator system implant~PrimeAdvanced® neurostimulator system: Neurostimulator and associated components"
133897|NCT01818297|E1|Reported Event|Treatment|"Treatment settings of Medtronic PrimeAdvanced® neurostimulator system implant~PrimeAdvanced® neurostimulator system: Neurostimulator and associated components"
133898|NCT01818141|B3|Baseline|Total|Total of all reporting groups
133899|NCT01818141|B2|Baseline|Vancomycin|"Vancomycin 125mg by mouth every 6 hours for 10 days~Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days"
133900|NCT01818141|B1|Baseline|Fidaxomicin|"Fidaxomicin 200mg by mouth every 12 hours for 10 days~Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days"
133901|NCT01818141|P2|Participant Flow|Vancomycin|"Vancomycin 125mg by mouth every 6 hours for 10 days~Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days"
133902|NCT01818141|P1|Participant Flow|Fidaxomicin|"Fidaxomicin 200mg by mouth every 12 hours for 10 days~Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days"
133903|NCT01818141|O2|Outcome|Vancomycin|"Vancomycin 125mg by mouth every 6 hours for 10 days~Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days"
133904|NCT01818141|O1|Outcome|Fidaxomicin|"Fidaxomicin 200mg by mouth every 12 hours for 10 days~Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days"
133905|NCT01818141|O2|Outcome|Vancomycin|"Vancomycin 125mg by mouth every 6 hours for 10 days~Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days"
133906|NCT01818141|O1|Outcome|Fidaxomicin|"Fidaxomicin 200mg by mouth every 12 hours for 10 days~Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days"
133907|NCT01818141|E2|Reported Event|Vancomycin|"Vancomycin 125mg by mouth every 6 hours for 10 days~Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days"
133908|NCT01818141|E1|Reported Event|Fidaxomicin|"Fidaxomicin 200mg by mouth every 12 hours for 10 days~Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days"
133909|NCT01818063|B3|Baseline|Total|Total of all reporting groups
133910|NCT01818063|B2|Baseline|Arm 2 (Veliparib, Paclitaxel, Carboplatin)|"Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Carboplatin: Given IV~Doxorubicin: Given IV~Cyclophosphamide: Given IV~Veliparib: Given PO"
133911|NCT01818063|B1|Baseline|Arm 1 (Paclitaxel, Carboplatin)|"Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Carboplatin: Given IV~Doxorubicin: Given IV~Cyclophosphamide: Given IV"
133912|NCT01818063|P2|Participant Flow|Arm 2 (Veliparib, Paclitaxel, Carboplatin)|"Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Carboplatin: Given IV~Doxorubicin: Given IV~Cyclophosphamide: Given IV~Veliparib: Given PO"
133913|NCT01818063|P1|Participant Flow|Arm 1 (Paclitaxel, Carboplatin)|"Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Carboplatin: Given IV~Doxorubicin: Given IV~Cyclophosphamide: Given IV"
133914|NCT01818063|O2|Outcome|Arm 2 (Veliparib, Paclitaxel, Carboplatin)|"Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Carboplatin: Given IV~Doxorubicin: Given IV~Cyclophosphamide: Given IV~Veliparib: Given PO"
133915|NCT01818063|O1|Outcome|Arm 1 (Paclitaxel, Carboplatin)|"Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Carboplatin: Given IV~Doxorubicin: Given IV~Cyclophosphamide: Given IV"
133916|NCT01818063|E2|Reported Event|Arm 2 (Veliparib, Paclitaxel, Carboplatin)|"Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Carboplatin: Given IV~Doxorubicin: Given IV~Cyclophosphamide: Given IV~Veliparib: Given PO"
133917|NCT01818063|E1|Reported Event|Arm 1 (Paclitaxel, Carboplatin)|"Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Carboplatin: Given IV~Doxorubicin: Given IV~Cyclophosphamide: Given IV"
133918|NCT01817907|B3|Baseline|Total|Total of all reporting groups
133919|NCT01817907|B2|Baseline|Trazodone First|"Subjects will receive trazodone during their treatment night sleep study~Trazodone: Subjects will receive trazodone during one of their treatment arm studies"
133920|NCT01817907|B1|Baseline|Placebo First|"Subjects will receive a sugar pill during their placebo night sleep study.~Placebo pill: Subjects will receive a sugar pill during the placebo arm"
133921|NCT01817907|P2|Participant Flow|Trazodone First|Subjects will receive a pill of trazodone (100 mg) during their first sleep study night and will receive a sugar pill (placebo) during their second sleep study night.
133922|NCT01817907|P1|Participant Flow|Placebo First|Subjects will receive a sugar pill (placebo) during their first sleep study night and will receive a pill of trazodone (100 mg) during their second sleep study night.
133923|NCT01817907|O2|Outcome|Trazodone|"Subjects will receive trazodone during their treatment night sleep study~Trazodone: Subjects will receive trazodone during one of their treatment arm studies"
133924|NCT01817907|O1|Outcome|Placebo|"Subjects will receive a sugar pill during their placebo night sleep study.~Placebo pill: Subjects will receive a sugar pill during the placebo arm"
133925|NCT01817907|O2|Outcome|Trazodone|"Subjects will receive trazodone during their treatment night sleep study~Trazodone: Subjects will receive trazodone during one of their treatment arm studies"
133926|NCT01817907|O1|Outcome|Placebo|"Subjects will receive a sugar pill during their placebo night sleep study.~Placebo pill: Subjects will receive a sugar pill during the placebo arm"
133927|NCT01817907|E2|Reported Event|Trazodone|"Subjects will receive trazodone during their treatment night sleep study~Trazodone: Subjects will receive trazodone during one of their treatment arm studies"
133928|NCT01817907|E1|Reported Event|Placebo|"Subjects will receive a sugar pill during their placebo night sleep study.~Placebo pill: Subjects will receive a sugar pill during the placebo arm"
133929|NCT01817855|B5|Baseline|Total|Total of all reporting groups
133930|NCT01817855|B4|Baseline|Placebo COPD|COPD Patients with Placebo, once daily
133931|NCT01817855|B3|Baseline|AZD7624 COPD|COPD patients with 966 µg or 1932 µg delivered dose of AZD7624, once daily
133932|NCT01817855|B2|Baseline|Placebo Healthy Volunteers|Healthy Volunteers with Placebo, once daily or twice daily
133933|NCT01817855|B1|Baseline|AZD7624 Healthy Volunteers|Healthy Volunteers with 261 µg to 2053 µg delivered dose of AZD7624, once daily or twice daily
133934|NCT01817855|P4|Participant Flow|Placebo COPD|COPD Patients with Placebo, once daily
133935|NCT01817855|P3|Participant Flow|AZD7624 COPD|COPD patients with 966 µg or 1932 µg delivered dose of AZD7624, once daily
133936|NCT01817855|P2|Participant Flow|Placebo Healthy Volunteers|Healthy Volunteers with Placebo, once daily or twice daily
133937|NCT01817855|P1|Participant Flow|AZD7624 Healthy Volunteers|Healthy Volunteers with 261 µg to 2053 µg delivered dose of AZD7624, once daily or twice daily
133938|NCT01817855|O6|Outcome|AZD7624 Healthy Volunteers Cohort 3|Healthy volunteers on Cohort 3 with 1027 µg delivered dose of AZD7624, twice daily
133939|NCT01817855|O5|Outcome|AZD7624 Healthy Volunteers Cohort 2|Healthy volunteers on Cohort 2 with 522 µg delivered dose of AZD7624, twice daily
133940|NCT01817855|O4|Outcome|AZD7624 Healthy Volunteers Cohort 1|Healthy volunteers on Cohort 1 with 261 µg delivered dose of AZD7624, twice daily
133941|NCT01817855|O3|Outcome|AZD7624 COPD Cohort 6|COPD patients on Cohort 6 with 966 µg delivered dose of AZD7624, once daily
133942|NCT01817855|O2|Outcome|AZD7624 Healthy Volunteers Cohort 5|Healthy volunteers on Cohort 5 with 2053 µg delivered dose of AZD7624 , once daily
133943|NCT01817855|O1|Outcome|AZD7624 COPD Cohort 4|COPD patients on Cohort 4 with 1932 µg delivered dose of AZD7624 , once daily
133944|NCT01817855|O6|Outcome|AZD7624 Healthy Volunteers Cohort 3|Healthy volunteers on Cohort 3 with 1027 µg delivered dose of AZD7624, twice daily
133945|NCT01817855|O5|Outcome|AZD7624 Healthy Volunteers Cohort 2|Healthy volunteers on Cohort 2 with 522 µg delivered dose of AZD7624, twice daily
133946|NCT01817855|O4|Outcome|AZD7624 Healthy Volunteers Cohort 1|Healthy volunteers on Cohort 1 with 261 µg delivered dose of AZD7624, twice daily
133947|NCT01817855|O3|Outcome|AZD7624 COPD Cohort 6|COPD patients on Cohort 6 with 966 µg delivered dose of AZD7624, once daily
133948|NCT01817855|O2|Outcome|AZD7624 Healthy Volunteers Cohort 5|Healthy volunteers on Cohort 5 with 2053 µg delivered dose of AZD7624 , once daily
133949|NCT01817855|O1|Outcome|AZD7624 COPD Cohort 4|COPD patients on Cohort 4 with 1932 µg delivered dose of AZD7624 , once daily
133950|NCT01817855|O6|Outcome|AZD7624 Healthy Volunteers Cohort 3|Healthy volunteers on Cohort 3 with 1027 µg delivered dose of AZD7624, twice daily
133951|NCT01817855|O5|Outcome|AZD7624 Healthy Volunteers Cohort 2|Healthy volunteers on Cohort 2 with 522 µg delivered dose of AZD7624, twice daily
133954|NCT01817855|O2|Outcome|AZD7624 Healthy Volunteers Cohort 5|Healthy volunteers on Cohort 5 with 2053 µg delivered dose of AZD7624 , once daily
133955|NCT01817855|O1|Outcome|AZD7624 COPD Cohort 4|COPD patients on Cohort 4 with 1932 µg delivered dose of AZD7624 , once daily
133956|NCT01817855|O4|Outcome|Placebo COPD|COPD Patients with Placebo, once daily
133957|NCT01817855|O3|Outcome|AZD7624 COPD|COPD patients with 966 µg or 1932 µg delivered dose of AZD7624, once daily
133958|NCT01817855|O2|Outcome|Placebo Healthy Volunteers|Healthy Volunteers with Placebo, once daily or twice daily
133959|NCT01817855|O1|Outcome|AZD7624 Healthy Volunteers|Healthy Volunteers with 261 µg to 2053 µg delivered dose of AZD7624, once daily or twice daily
133960|NCT01817855|E4|Reported Event|Placebo COPD|COPD Patients with Placebo, once daily
133961|NCT01817855|E3|Reported Event|AZD7624 COPD|COPD patients with 966 µg or 1932 µg delivered dose of AZD7624, once daily
133962|NCT01817855|E2|Reported Event|Placebo Healthy Volunteers|Healthy Volunteers with Placebo, once daily or twice daily
133963|NCT01817855|E1|Reported Event|AZD7624 Healthy Volunteers|Healthy Volunteers with 261 µg to 2053 µg delivered dose of AZD7624, once daily or twice daily
133964|NCT01817790|B3|Baseline|Total|Total of all reporting groups
133965|NCT01817790|B2|Baseline|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
133966|NCT01817790|B1|Baseline|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
133967|NCT01817790|P2|Participant Flow|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
133968|NCT01817790|P1|Participant Flow|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
133969|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
133970|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
133971|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
133972|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
133973|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
133974|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
133975|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
133976|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
133977|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
133978|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
133979|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
133980|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
133981|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
133982|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
133983|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
133984|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
133985|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
133986|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
133987|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
133988|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
133989|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
133990|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
133991|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
133992|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
133993|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
133994|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
133995|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning
133996|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
133997|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning
133998|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
133999|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
157775|NCT01717989|O4|Outcome|Q3 2011|Third quarter (Q3) 2011
134000|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
134001|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
134002|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
134003|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
134004|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
134005|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
134006|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning.
134007|NCT01817790|E2|Reported Event|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
134008|NCT01817790|E1|Reported Event|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
134009|NCT01817777|B3|Baseline|Total|Total of all reporting groups
134010|NCT01817777|B2|Baseline|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
134011|NCT01817777|B1|Baseline|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
134012|NCT01817777|P3|Participant Flow|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
134013|NCT01817777|P2|Participant Flow|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
134014|NCT01817777|P1|Participant Flow|Routine Metformin|Participants were followed during an 8-week Observational Phase. During this phase, participants visited the pharmacy and purchased metformin (MTF) as per their usual routines.
134015|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
134016|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
134017|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
134018|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
134019|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
134020|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
134021|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
134022|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
134023|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
134024|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
134025|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
134354|NCT01815099|E1|Reported Event|rTMS Treatment|rTMS Treatment: will entail twice weekly rTMS sessions for 5 weeks.
134026|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
134027|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
134028|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
134029|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
134030|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
134031|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
134032|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
134033|NCT01817777|E2|Reported Event|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
134034|NCT01817777|E1|Reported Event|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
134035|NCT01817764|B3|Baseline|Total|Total of all reporting groups
134036|NCT01817764|B2|Baseline|FSC 250/50 µg BID|Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
134037|NCT01817764|B1|Baseline|UMEC/VI 62.5/25 µg QD|Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.
134038|NCT01817764|P2|Participant Flow|FSC 250/50 µg BID|Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
134039|NCT01817764|P1|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.
134040|NCT01817764|O2|Outcome|FSC 250/50 µg BID|Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
134041|NCT01817764|O1|Outcome|UMEC/VI 62.5/25 µg QD|Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.
134042|NCT01817764|O2|Outcome|FSC 250/50 µg BID|Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
134043|NCT01817764|O1|Outcome|UMEC/VI 62.5/25 µg QD|Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.
134044|NCT01817764|E2|Reported Event|FSC 250/50 µg BID|Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
134045|NCT01817764|E1|Reported Event|UMEC/VI 62.5/25 µg QD|Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.
134046|NCT01817725|B1|Baseline|Engerix-B|"Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for >20 years old and 20μg for < or =20 years old~HBV vaccine (Engerix B): Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage will be 20μg in those <= 20 years old and 40μg in those > 20 years old."
134047|NCT01817725|P1|Participant Flow|Engerix-B|"Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for >20 years old and 20μg for < or =20 years old~HBV vaccine (Engerix B): Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage is 20μg in those <= 20 years old and 40μg in those > 20 years old."
134077|NCT01816776|B2|Baseline|Control Group|Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
134078|NCT01816776|B1|Baseline|Treatment Group|Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
134048|NCT01817725|O1|Outcome|Engerix-B|"Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for >20 years old and 20μg for < or =20 years old~HBV vaccine (Engerix B): Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage is 20μg in those <= 20 years old and 40μg in those > 20 years old."
134049|NCT01817725|O1|Outcome|Engerix-B|"Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for >20 years old and 20μg for < or =20 years old~HBV vaccine (Engerix B): Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage is 20μg in those <= 20 years old and 40μg in those > 20 years old."
134050|NCT01817725|E1|Reported Event|Engerix-B|"Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for >20 years old and 20μg for < or =20 years old~HBV vaccine (Engerix B): Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage is 20μg in those <= 20 years old and 40μg in those > 20 years old."
134051|NCT01817374|B1|Baseline|Evaluation of VCEUS to Determine Response to Chemotherapy|"Patients with breast cancer receiving neoadjuvant chemotherapy will undergo quantitative VCEUS imaging and 2D grayscale imaging as follows:~prior to initiation of treatment (baseline);~at 14 (± 4 days) after initiation of neoadjuvant chemotherapy (early treatment);~at 28 days (± 4 days) after initiation of neoadjuvant chemotherapy (inter-regimen);~at completion of therapy prior to definitive surgery (usually 2-3 months after initiation of treatment). Each patient will undergo a total of four VCEUS examinations.~Definity (Perflutren Lipid Microspheres): This is a pilot study to evaluate quantitative VCEUS imaging for determining early breast cancer response to neoadjuvant chemotherapy, comparing results with volume change on grayscale US and planar CEUS, and correlating imaging findings with pathological response on surgical specimens."
134052|NCT01817374|P1|Participant Flow|Evaluation of VCEUS to Determine Response to Chemotherapy|"Patients with breast cancer receiving neoadjuvant chemotherapy will undergo 2D grayscale imaging followed by the quantitative VCEUS imaging as follows:~prior to initiation of treatment (baseline);~at 14 (± 4 days) after initiation of neoadjuvant chemotherapy (early treatment);~at 28 days (± 4 days) after initiation of neoadjuvant chemotherapy (inter-regimen);~at completion of therapy prior to definitive surgery (usually 2-3 months after initiation of treatment). Each patient will undergo a total of four VCEUS examinations.~Definity (Perflutren Lipid Microspheres): This is a pilot study to evaluate quantitative VCEUS imaging for determining early breast cancer response to neoadjuvant chemotherapy, comparing results with volume change on grayscale US and planar CEUS, and correlating imaging findings with pathological response on surgical specimens."
134053|NCT01817374|O1|Outcome|Pathology Residual|Pathology residual tumor measured in millimeters
134054|NCT01817374|O1|Outcome|VCEUS Perfusion Time to Peak|Time from contrast injection to peak intensity
134055|NCT01817374|O1|Outcome|VCEUS Perfusion Time to Peak|Time from contrast injection to peak intensity
134056|NCT01817374|O1|Outcome|VCEUS Perfusion Time to Peak|Time from contrast injection to peak intensity
134057|NCT01817374|O1|Outcome|Grayscale Ultrasound|Patients with breast cancer receiving neoadjuvant chemotherapy will undergo a 2D grayscale imaging prior to initiation of treatment (baseline);
134058|NCT01817374|O1|Outcome|Grayscale Ultrasound|Patients with breast cancer receiving neoadjuvant chemotherapy will undergo a 2D grayscale imaging prior to initiation of treatment (baseline);
134059|NCT01817374|O1|Outcome|Grayscale Ultrasound|Patients with breast cancer receiving neoadjuvant chemotherapy will undergo a 2D grayscale imaging prior to initiation of treatment (baseline);
134060|NCT01817374|O1|Outcome|VCEUS Perfusion Time to Peak|Time from contrast injection to peak intensity
134061|NCT01817374|O1|Outcome|Grayscale Ultrasound|Patients with breast cancer receiving neoadjuvant chemotherapy will undergo a 2D grayscale imaging prior to initiation of treatment (baseline);
134062|NCT01817374|E1|Reported Event|Definity VCEUS|"Patients with breast cancer receiving neoadjuvant chemotherapy will undergo quantitative VCEUS imaging and 2D grayscale imaging as follows:~prior to initiation of treatment (baseline);~at 14 (± 4 days) after initiation of neoadjuvant chemotherapy (early treatment);~at 28 days (± 4 days) after initiation of neoadjuvant chemotherapy (inter-regimen);~at completion of therapy prior to definitive surgery (usually 2-3 months after initiation of treatment). Each patient will undergo a total of four VCEUS examinations.~Definity (Perflutren Lipid Microspheres): This is a pilot study to evaluate quantitative VCEUS imaging for determining early breast cancer response to neoadjuvant chemotherapy, comparing results with volume change on grayscale US and planar CEUS, and correlating imaging findings with pathological response on surgical specimens."
134063|NCT01816893|B3|Baseline|Total|Total of all reporting groups
134064|NCT01816893|B2|Baseline|Hypoglycemic Clamp/ Washout Period/ Euglycemic Clamp|"Participant undergoes a hypoglycemic hyperinsulinemic clamp~Participant undergoes a 1-3 month washout period~Participant undergoes a euglycemic hyperinsulinemic clamp"
134065|NCT01816893|B1|Baseline|Euglycemic Clamp/ Washout Period/ Hypoglycemic Clamp|"Participant undergoes a euglycemic hyperinsulinemic clamp~Participant undergoes a 1-3 month washout period~Participant undergoes a hypoglycemic hyperinsulinemic clamp"
134066|NCT01816893|P2|Participant Flow|Hypoglycemic Clamp/ Washout Period/ Euglycemic Clamp|"Participant undergoes a hypoglycemic hyperinsulinemic clamp~Participant undergoes a 1-3 month washout period~Participant undergoes a euglycemic hyperinsulinemic clamp"
134067|NCT01816893|P1|Participant Flow|Euglycemic Clamp/ Washout Period/ Hypoglycemic Clamp|"Participant undergoes a euglycemic hyperinsulinemic clamp~Participant undergoes a 1-3 month washout period~Participant undergoes a hypoglycemic hyperinsulinemic clamp"
134068|NCT01816893|O2|Outcome|Hypoglycemic Clamp|"participant undergoes a hypoglycemic hyperinsulinemic clamp~Hypoglycemia"
134069|NCT01816893|O1|Outcome|Euglycemic Clamp|"participant undergoes a euglycemic hyperinsulinemic clamp~Euglycemia"
134070|NCT01816893|O2|Outcome|Hypoglycemic Clamp|"participant undergoes a hypoglycemic hyperinsulinemic clamp~Hypoglycemia"
134071|NCT01816893|O1|Outcome|Euglycemic Clamp|"participant undergoes a euglycemic hyperinsulinemic clamp~Euglycemia"
134072|NCT01816893|O2|Outcome|Hypoglycemic Clamp|"participant undergoes a hypoglycemic hyperinsulinemic clamp~Hypoglycemia"
134073|NCT01816893|O1|Outcome|Euglycemic Clamp|"participant undergoes a euglycemic hyperinsulinemic clamp~Euglycemia"
134074|NCT01816893|E2|Reported Event|Hypoglycemic Clamp|Participant undergoes a hypoglycemic hyperinsulinemic clamp
134079|NCT01816776|P2|Participant Flow|Control Group|Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
134080|NCT01816776|P1|Participant Flow|Treatment Group|Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
134081|NCT01816776|O2|Outcome|Control Group|Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
134082|NCT01816776|O1|Outcome|Treatment Group|Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
134083|NCT01816776|O2|Outcome|Control Group|Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
134084|NCT01816776|O1|Outcome|Treatment Group|Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
134085|NCT01816776|O2|Outcome|Control Group|Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
134086|NCT01816776|O1|Outcome|Treatment Group|Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
134087|NCT01816776|O2|Outcome|Control Group|Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
134088|NCT01816776|O1|Outcome|Treatment Group|Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
134089|NCT01816776|O2|Outcome|Control Group|Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
134090|NCT01816776|O1|Outcome|Treatment Group|Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
134091|NCT01816776|O2|Outcome|Control Group|Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
134092|NCT01816776|O1|Outcome|Treatment Group|Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
134093|NCT01816776|O2|Outcome|Control Group|Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
134094|NCT01816776|O1|Outcome|Treatment Group|Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
134095|NCT01816776|O1|Outcome|Pooled Group|All randomized participants pooled. All subjects were implanted with the remedē System device and received optimal medical therapy. The Treatment group had received 12 months active therapy and Control had received 6 months active therapy.
134096|NCT01816776|O2|Outcome|Control Group|Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
134097|NCT01816776|O1|Outcome|Treatment Group|Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
134098|NCT01816776|E1|Reported Event|Pooled Group|The study protocol pre-specified that randomized groups be combined to assess safety. All subjects were implanted with the remedē System device and received optimal medical therapy. The Treatment group had received 12 months active therapy and Control had received 6 months active therapy.
134099|NCT01816685|B3|Baseline|Total|Total of all reporting groups
134100|NCT01816685|B2|Baseline|Routine Care|Routine care will be provided to the participant.
134101|NCT01816685|B1|Baseline|CPAP|Patients in the continuous positive airway pressure (CPAP) group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.
134102|NCT01816685|P2|Participant Flow|Routine Care|Routine care will be provided to the participant.
134103|NCT01816685|P1|Participant Flow|CPAP|Patients in the continuous positive airway pressure (CPAP) group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.
134104|NCT01816685|O2|Outcome|Routine Care|Routine care will be provided to the participant.
134105|NCT01816685|O1|Outcome|CPAP|Patients in the continuous positive airway pressure (CPAP) group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.
134106|NCT01816685|O2|Outcome|Routine Care|Routine care will be provided to the participant.
134107|NCT01816685|O1|Outcome|CPAP|Patients in the continuous positive airway pressure (CPAP) group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.
134108|NCT01816685|E2|Reported Event|Routine Care|Routine care will be provided to the participant.
134109|NCT01816685|E1|Reported Event|CPAP|"Patients in the CPAP group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.~CPAP"
134110|NCT01816477|B3|Baseline|Total|Total of all reporting groups
134111|NCT01816477|B2|Baseline|ON-Q Soaker Catheter System|ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5” catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia.
134112|NCT01816477|B1|Baseline|Thoracic Epidural|Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
134113|NCT01816477|P2|Participant Flow|ON-Q Soaker Catheter System|ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5” catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia.
134114|NCT01816477|P1|Participant Flow|Thoracic Epidural|Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
134635|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
134115|NCT01816477|O2|Outcome|ON-Q Soaker Catheter System|ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5” catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia.
134116|NCT01816477|O1|Outcome|Thoracic Epidural|Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
134117|NCT01816477|O2|Outcome|ON-Q Soaker Catheter System|ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5” catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia.
134118|NCT01816477|O1|Outcome|Thoracic Epidural|Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
134119|NCT01816477|O2|Outcome|ON-Q Soaker Catheter System|ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5” catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia.
134120|NCT01816477|O1|Outcome|Thoracic Epidural|Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
134121|NCT01816477|E2|Reported Event|ON-Q Soaker Catheter System|ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5” catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia.
134122|NCT01816477|E1|Reported Event|Thoracic Epidural|Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
134123|NCT01816451|B4|Baseline|Total|Total of all reporting groups
134124|NCT01816451|B3|Baseline|Control|The control group did not do the running training program. Control did their normal physical activities.
134125|NCT01816451|B2|Baseline|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
134126|NCT01816451|B1|Baseline|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax-maximal heart rate (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
134127|NCT01816451|P3|Participant Flow|Control|The control group did not do the running training program. Control did their normal physical activities.
134128|NCT01816451|P2|Participant Flow|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
134129|NCT01816451|P1|Participant Flow|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
134130|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
134131|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
134132|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
134133|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
134134|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
134135|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
135302|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
134136|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
134137|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
134138|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
134139|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
134140|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
134141|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
134142|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
134143|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
134144|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
134145|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
134146|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
134147|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
134148|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
134149|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
134150|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
134151|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
134152|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
134153|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
134154|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
134155|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
134156|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
134157|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
134158|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
134159|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
134160|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine.The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
134161|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax-maximal heart rate (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
134162|NCT01816451|E3|Reported Event|Control|The control group did not do the running training program. Control did their normal physical activities.
134163|NCT01816451|E2|Reported Event|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
134164|NCT01816451|E1|Reported Event|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
134165|NCT01816295|B3|Baseline|Total|Total of all reporting groups
134166|NCT01816295|B2|Baseline|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
134167|NCT01816295|B1|Baseline|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
134168|NCT01816295|P2|Participant Flow|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
134169|NCT01816295|P1|Participant Flow|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
134170|NCT01816295|O2|Outcome|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
134171|NCT01816295|O1|Outcome|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
134172|NCT01816295|O2|Outcome|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
134173|NCT01816295|O1|Outcome|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
134174|NCT01816295|O2|Outcome|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
134175|NCT01816295|O1|Outcome|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
134176|NCT01816295|O2|Outcome|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
134177|NCT01816295|O1|Outcome|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
134178|NCT01816295|O2|Outcome|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
134179|NCT01816295|O1|Outcome|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
134180|NCT01816295|E3|Reported Event|Testosterone Solution - OLE|Sixty mg testosterone solution applied topically to axillae once daily at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks in optional OLE period.
134181|NCT01816295|E2|Reported Event|Testosterone Solution - Double Blind|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period.
134182|NCT01816295|E1|Reported Event|Placebo Solution - Double Blind|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period.
134183|NCT01816243|B1|Baseline|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
134184|NCT01816243|P1|Participant Flow|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
134185|NCT01816243|O1|Outcome|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
134186|NCT01816243|O1|Outcome|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
134187|NCT01816243|O1|Outcome|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
134188|NCT01816243|O1|Outcome|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
134189|NCT01816243|E1|Reported Event|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
134190|NCT01816074|B5|Baseline|Total|Total of all reporting groups
134191|NCT01816074|B4|Baseline|BPT Then Maternal Medication|"The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
134231|NCT01816048|O1|Outcome|TAK-700|"TAK-700 will be administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.~TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles~Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan at screen, week 4-8 and week 12"
134192|NCT01816074|B3|Baseline|Maternal Medication Then BPT|"The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training).~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
134193|NCT01816074|B2|Baseline|BPT Then Continued Beh tx|"The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
134194|NCT01816074|B1|Baseline|Maternal Medication Then Meds|"The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to enhanced medication~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother."
134195|NCT01816074|P4|Participant Flow|BPT Then Maternal Medication|"The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
134196|NCT01816074|P3|Participant Flow|Maternal Medication Then BPT|"The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training).~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
134197|NCT01816074|P2|Participant Flow|Maternal Behavioral Parent Training (BPT) Then Additional BPT|"The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
134198|NCT01816074|P1|Participant Flow|Maternal Medication Then Additional Maternal Medication|"The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to enhanced medication~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother."
134199|NCT01816074|O12|Outcome|Behavior Parent Training Then Additional BPT - Week 16|"The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
134200|NCT01816074|O11|Outcome|Behavior Parent Training Then Additional BPT - Week 8|"The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
134201|NCT01816074|O10|Outcome|Behavior Parent Training Then Additional BPT - Baseline|"The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
134202|NCT01816074|O9|Outcome|Behavior Parent Training Then Maternal Medication - Week 16|"The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
134203|NCT01816074|O8|Outcome|Behavior Parent Training Then Maternal Medication - Week 8|"The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
134204|NCT01816074|O7|Outcome|Behavior Parent Training Then Maternal Medication - Baseline|"The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
134205|NCT01816074|O6|Outcome|Maternal Medication Then Behavior Parent Training - Week 16|"The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training).~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
134206|NCT01816074|O5|Outcome|Maternal Medication Then Behavior Parent Training - Week 8|"The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training).~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
134207|NCT01816074|O4|Outcome|Maternal Medication Then Behavior Parent Training - Baseline|"The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training).~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
134208|NCT01816074|O3|Outcome|Maternal Medication Then Additional Maternal Med - Week 16|"The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to enhanced medication~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother."
134209|NCT01816074|O2|Outcome|Maternal Medication Then Additional Maternal Med - Week 8|"The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to enhanced medication~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother."
136141|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
134210|NCT01816074|O1|Outcome|Maternal Medication Then Additional Maternal Med - Baseline|"The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to enhanced medication~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother."
134211|NCT01816074|O4|Outcome|BPT Then Maternal Medication|"The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
134212|NCT01816074|O3|Outcome|Maternal Medication Then BPT|"The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training).~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
134213|NCT01816074|O2|Outcome|Maternal Behavioral Parent Training (BPT) Then Additional BPT|"The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
134214|NCT01816074|O1|Outcome|Maternal Medication Then Additional Maternal Medication|"The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to enhanced medication~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother."
134215|NCT01816074|O4|Outcome|BPT Then Maternal Medication|"The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
134216|NCT01816074|O3|Outcome|Maternal Medication Then BPT|"The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training).~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
134217|NCT01816074|O2|Outcome|Maternal Behavioral Parent Training (BPT) Then Additional BPT|"The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.~Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training"
134218|NCT01816074|O1|Outcome|Maternal Medication Then Additional Maternal Medication|"The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to enhanced medication~Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother."
134219|NCT01816074|E6|Reported Event|Vyvanse 70mg|Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. For the mothers that were randomized to medication arm, 70mg was offered to the mother if 60mg was not a strong enough dose.
134220|NCT01816074|E5|Reported Event|Vyvanse 60 mg|Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. For the mothers that were randomized to medication arm, 60mg was offered to the mother if 50mg was not a strong enough dose.
134221|NCT01816074|E4|Reported Event|Vyvanse 50 mg|Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. For the mothers that were randomized to medication arm, 50mg was offered to the mother if 40mg was not a strong enough dose.
134222|NCT01816074|E3|Reported Event|Vyvanse 40mg|Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. For the mothers that were randomized to medication arm, 40mg was offered to the mother if 30mg was not a strong enough dose.
134223|NCT01816074|E2|Reported Event|Vyvanse 30 mg|Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. For the mothers that were randomized to medication arm, 30mg was offered to the mother if 20mg was not a strong enough dose.
134224|NCT01816074|E1|Reported Event|Vyvanse 20 mg|Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. For the mothers that were randomized to medication arm, 20mg was the first dose they received.
134225|NCT01816048|B1|Baseline|TAK-700|"TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.~TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles~Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan~Positron Emission Tomography: Undergo 18F NaF PET/CT scan~Computed Tomography: Undergo 18F NaF PET/CT scan"
134226|NCT01816048|P1|Participant Flow|TAK-700|"TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.~TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles~Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan~Positron Emission Tomography: Undergo 18F NaF PET/CT scan~Computed Tomography: Undergo 18F NaF PET/CT scan"
134227|NCT01816048|O1|Outcome|TAK-700|"TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.~TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles~Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan~Positron Emission Tomography: Undergo 18F NaF PET/CT scan~Computed Tomography: Undergo 18F NaF PET/CT scan"
134228|NCT01816048|O1|Outcome|TAK-700|"TAK-700 will be administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.~TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles~Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan at screen, week 4-8 and week 12"
134229|NCT01816048|O1|Outcome|TAK-700|"TAK-700 will be administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.~TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles~Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan at screen, week 4-8 and week 12"
134230|NCT01816048|O1|Outcome|TAK-700|"TAK-700 will be administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.~TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles~Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan at screen, week 4-8 and week 12"
134351|NCT01815099|P1|Participant Flow|rTMS Treatment|This was an open trial. All participants received active rTMS
134232|NCT01816048|O1|Outcome|TAK-700|"TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.~TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles~Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan~Positron Emission Tomography: Undergo 18F NaF PET/CT scan~Computed Tomography: Undergo 18F NaF PET/CT scan"
134233|NCT01816048|O1|Outcome|TAK-700|"TAK-700 will be administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.~TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles~Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan at screen, week 4-8 and week 12"
134234|NCT01816048|O1|Outcome|TAK-700|"TAK-700 will be administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.~TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles~Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan at screen, week 4-8 and week 12"
134235|NCT01816048|O1|Outcome|TAK-700|"TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.~TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles~Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan~Positron Emission Tomography: Undergo 18F NaF PET/CT scan~Computed Tomography: Undergo 18F NaF PET/CT scan"
134236|NCT01816048|O1|Outcome|TAK-700|"TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.~TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles~Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan~Positron Emission Tomography: Undergo 18F NaF PET/CT scan~Computed Tomography: Undergo 18F NaF PET/CT scan"
134237|NCT01816048|E1|Reported Event|TAK-700|"TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.~TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles~Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan~Positron Emission Tomography: Undergo 18F NaF PET/CT scan~Computed Tomography: Undergo 18F NaF PET/CT scan"
134238|NCT01815918|B3|Baseline|Total|Total of all reporting groups
134239|NCT01815918|B2|Baseline|Treatment|"Patients receive 3 100 mg of hydrocortisone: prior to surgery, 8 hours after the first dose and 16 hours after the first dose.~Hydrocortisone: Patients randomized to treatment arm will three doses of 100 mg of hydrocortisone at the following times: prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
134240|NCT01815918|B1|Baseline|Placebo|"Patients receive a saline placebo before surgery, 8 hours after the first dose and 16 hours after the first dose.~Placebo: Patients receive placebo prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
134241|NCT01815918|P2|Participant Flow|Treatment|"Patients receive 3 100 mg of hydrocortisone: prior to surgery, 8 hours after the first dose and 16 hours after the first dose.~Hydrocortisone: Patients randomized to treatment arm will three doses of 100 mg of hydrocortisone at the following times: prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
134242|NCT01815918|P1|Participant Flow|Placebo|"Patients receive a saline placebo before surgery, 8 hours after the first dose and 16 hours after the first dose.~Placebo: Patients receive placebo prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
134243|NCT01815918|O2|Outcome|Treatment|
134244|NCT01815918|O1|Outcome|Placebo|
134245|NCT01815918|O2|Outcome|Treatment|
134246|NCT01815918|O1|Outcome|Placebo|
134247|NCT01815918|O2|Outcome|Treatment|Data was not collected
134248|NCT01815918|O1|Outcome|Placebo|Data was not collected
134249|NCT01815918|O2|Outcome|Treatment|
134250|NCT01815918|O1|Outcome|Placebo|
134251|NCT01815918|O2|Outcome|Treatment|"Patients receive 3 100 mg of hydrocortisone: prior to surgery, 8 hours after the first dose and 16 hours after the first dose.~Hydrocortisone: Patients randomized to treatment arm will three doses of 100 mg of hydrocortisone at the following times: prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
134252|NCT01815918|O1|Outcome|Placebo|"Patients receive a saline placebo before surgery, 8 hours after the first dose and 16 hours after the first dose.~Placebo: Patients receive placebo prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
134253|NCT01815918|E2|Reported Event|Treatment|"Patients receive 3 100 mg of hydrocortisone: prior to surgery, 8 hours after the first dose and 16 hours after the first dose.~Hydrocortisone: Patients randomized to treatment arm will three doses of 100 mg of hydrocortisone at the following times: prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
134254|NCT01815918|E1|Reported Event|Placebo|"Patients receive a saline placebo before surgery, 8 hours after the first dose and 16 hours after the first dose.~Placebo: Patients receive placebo prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
134255|NCT01815840|B3|Baseline|Total|Total of all reporting groups
134256|NCT01815840|B2|Baseline|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134257|NCT01815840|B1|Baseline|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134258|NCT01815840|P2|Participant Flow|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134259|NCT01815840|P1|Participant Flow|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134260|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134261|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134262|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134263|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134264|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134265|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134266|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134267|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134268|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134269|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134270|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134271|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134272|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134273|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134274|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134275|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134276|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134277|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134278|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134279|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134280|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134281|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134282|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134283|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134284|NCT01815840|E2|Reported Event|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134285|NCT01815840|E1|Reported Event|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
134286|NCT01815736|B3|Baseline|Total|Total of all reporting groups
134287|NCT01815736|B2|Baseline|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
134288|NCT01815736|B1|Baseline|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
134289|NCT01815736|P2|Participant Flow|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen E/C/F/TDF (Stribild®); efavirenz (EFV)/FTC/TDF (Atripla®); ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
134290|NCT01815736|P1|Participant Flow|E/C/F/TAF|Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
134291|NCT01815736|O2|Outcome|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
134292|NCT01815736|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
134293|NCT01815736|O2|Outcome|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
134294|NCT01815736|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
134295|NCT01815736|O2|Outcome|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
134296|NCT01815736|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
134297|NCT01815736|O2|Outcome|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
134298|NCT01815736|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
134299|NCT01815736|O2|Outcome|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
134300|NCT01815736|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
134301|NCT01815736|E2|Reported Event|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
134302|NCT01815736|E1|Reported Event|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
134303|NCT01815671|B3|Baseline|Total|Total of all reporting groups
134304|NCT01815671|B2|Baseline|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
134305|NCT01815671|B1|Baseline|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
134306|NCT01815671|P2|Participant Flow|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
134307|NCT01815671|P1|Participant Flow|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
134308|NCT01815671|O2|Outcome|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
134309|NCT01815671|O1|Outcome|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
134310|NCT01815671|O2|Outcome|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
134311|NCT01815671|O1|Outcome|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
134312|NCT01815671|O2|Outcome|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
134313|NCT01815671|O1|Outcome|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
134314|NCT01815671|E2|Reported Event|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
134315|NCT01815671|E1|Reported Event|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
134316|NCT01815645|B3|Baseline|Total|Total of all reporting groups
134317|NCT01815645|B2|Baseline|Standard Treatment Plus Contingency Management|Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
134318|NCT01815645|B1|Baseline|Standard Treatment|standard treatment: 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
134319|NCT01815645|P2|Participant Flow|Standard Treatment Plus Contingency Management|33 participants received Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
134320|NCT01815645|P1|Participant Flow|Standard Treatment|standard treatment: 32 participants received 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
134321|NCT01815645|O2|Outcome|Standard Treatment Plus Contingency Management|33 participants received Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
134322|NCT01815645|O1|Outcome|Standard Treatment|standard treatment: 32 participants received 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
157776|NCT01717989|O3|Outcome|Q2 2011|Second quarter (Q2), 2011
134323|NCT01815645|O2|Outcome|Standard Treatment Plus Contingency Management|33 participants received Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
134324|NCT01815645|O1|Outcome|Standard Treatment|standard treatment: 32 participants received 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
134325|NCT01815645|O2|Outcome|Standard Treatment Plus Contingency Management|Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
134326|NCT01815645|O1|Outcome|Standard Treatment|standard treatment: 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
134327|NCT01815645|O2|Outcome|Standard Treatment Plus Contingency Management|Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
134328|NCT01815645|O1|Outcome|Standard Treatment|standard treatment: 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
134329|NCT01815645|O2|Outcome|Standard Treatment Plus Contingency Management|33 participants received Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
134330|NCT01815645|O1|Outcome|Standard Treatment|standard treatment: 32 participants received 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
134331|NCT01815645|O2|Outcome|Standard Treatment Plus Contingency Management|Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
134332|NCT01815645|O1|Outcome|Standard Treatment|standard treatment: 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
134333|NCT01815645|E2|Reported Event|Standard Treatment Plus Contingency Management|Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
134334|NCT01815645|E1|Reported Event|Standard Treatment|standard treatment: 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
134335|NCT01815138|B3|Baseline|Total|Total of all reporting groups
134336|NCT01815138|B2|Baseline|hCG Given 35 Hours After GnRHa Trigger|"Placebo administered at the time of GnRH agonist trigger~Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger.~hCG: Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger"
134337|NCT01815138|B1|Baseline|hCG Given at Time of GnRHa Trigger|"Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger.~Placebo administered 35 hours after GnRH agonist trigger~hCG: Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger"
134338|NCT01815138|P2|Participant Flow|hCG Given 35 Hours After GnRHa Trigger|"Placebo administered at the time of GnRH agonist trigger~Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger.~hCG: Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger"
134339|NCT01815138|P1|Participant Flow|hCG Given at Time of GnRHa Trigger|"Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger.~Placebo administered 35 hours after GnRH agonist trigger~hCG: Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger"
134340|NCT01815138|O2|Outcome|hCG Given 35 Hours After GnRHa Trigger|"Placebo administered at the time of GnRH agonist trigger~Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger.~hCG: Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger"
134341|NCT01815138|O1|Outcome|hCG Given at Time of GnRHa Trigger|"Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger.~Placebo administered 35 hours after GnRH agonist trigger~hCG: Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger"
134342|NCT01815138|O2|Outcome|hCG Given 35 Hours After GnRHa Trigger|"Placebo administered at the time of GnRH agonist trigger~Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger.~hCG: Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger"
134343|NCT01815138|O1|Outcome|hCG Given at Time of GnRHa Trigger|"Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger.~Placebo administered 35 hours after GnRH agonist trigger~hCG: Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger"
134344|NCT01815138|O2|Outcome|hCG Given 35 Hours After GnRHa Trigger|"Placebo administered at the time of GnRH agonist trigger~Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger.~hCG: Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger"
134345|NCT01815138|O1|Outcome|hCG Given at Time of GnRHa Trigger|"Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger.~Placebo administered 35 hours after GnRH agonist trigger~hCG: Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger"
134346|NCT01815138|O2|Outcome|hCG Given 35 Hours After GnRHa Trigger|"Placebo administered at the time of GnRH agonist trigger~Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger.~hCG: Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger"
134347|NCT01815138|O1|Outcome|hCG Given at Time of GnRHa Trigger|"Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger.~Placebo administered 35 hours after GnRH agonist trigger~hCG: Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger"
134348|NCT01815138|E2|Reported Event|hCG Given 35 Hours After GnRHa Trigger|"Placebo administered at the time of GnRH agonist trigger~Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger.~hCG: Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger"
134349|NCT01815138|E1|Reported Event|hCG Given at Time of GnRHa Trigger|"Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger.~Placebo administered 35 hours after GnRH agonist trigger~hCG: Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger"
134350|NCT01815099|B1|Baseline|rTMS Treatment|rTMS Treatment: will entail twice weekly rTMS sessions for 5 weeks.
134355|NCT01815008|B1|Baseline|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Aspirin: Aspirin 81 mg daily"
134356|NCT01815008|P1|Participant Flow|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Aspirin: Aspirin 81 mg daily"
134357|NCT01815008|O1|Outcome|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Aspirin: Aspirin 81 mg daily~Note: The 2nd week of the study was not performed as we could not find low risk population in our cohort who could be given both anti-platelets without increased estimated risk of bleeding."
134358|NCT01815008|O1|Outcome|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Aspirin: Aspirin 81 mg daily"
134359|NCT01815008|O1|Outcome|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Note: The 2nd week of the study was not performed as we could not find low risk population in our cohort who could be given both anti-platelets without increased estimated risk of bleeding."
134360|NCT01815008|O1|Outcome|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Aspirin: Aspirin 81 mg daily"
134361|NCT01815008|E1|Reported Event|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Aspirin: Aspirin 81 mg daily"
134362|NCT01814878|B3|Baseline|Total|Total of all reporting groups
134363|NCT01814878|B2|Baseline|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
134364|NCT01814878|B1|Baseline|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
134365|NCT01814878|P2|Participant Flow|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
134366|NCT01814878|P1|Participant Flow|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
134367|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
134368|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
134369|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
134370|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
134371|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
134372|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
134373|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
134374|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
134375|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
134376|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
134377|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
134378|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
134379|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
134380|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
134381|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
134382|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
134383|NCT01814878|E2|Reported Event|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
134384|NCT01814878|E1|Reported Event|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
134385|NCT01814800|B1|Baseline|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134386|NCT01814800|P1|Participant Flow|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg IV infusion Frequency: Every 3 or 4 weeks~Initial dose selection based on prior IGIV regimen, doses adjusted during study to maintain trough Immunoglobulin G (IgG) concentration of 500 mg/dL or greater according to investigator decision."
134387|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134388|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134389|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134390|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134391|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134392|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134393|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134394|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134395|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134396|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134397|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134398|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134399|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134400|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134401|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134402|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134403|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134404|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134405|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134406|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134407|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134408|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134409|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134410|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134411|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134412|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134413|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134414|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134415|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134416|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134417|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134418|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134419|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134420|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134421|NCT01814800|E1|Reported Event|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
134422|NCT01814787|B3|Baseline|Total|Total of all reporting groups
134438|NCT01814774|O1|Outcome|BOTOX®|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
136524|NCT01806857|E2|Reported Event|Matching Placebo|Includes all subjects that took matching placebo
134423|NCT01814787|B2|Baseline|Usual Care|Those patients who are assigned to the control group will have the CHICA system but will NOT be cared for using the CHICA Type 2 Diabetes Module. The CHICA system will notify the physician of the child’s BMI percentile on the physician worksheet. However, the CHICA system will not ask for any additional information related to risk factors for type 2 diabetes on the pre-screening form, no advice will be provided to the physician on the physician worksheet, nor will just-in-time documents or automated reminder calls be made available. Identification of patients at risk for type 2 diabetes and care of those patients will occur through routine practices for that clinic.
134424|NCT01814787|B1|Baseline|CHICA Type 2 Diabetes Module|"Children treated at the two intervention clinic sites will have be treated using the CHICA system AND will be provided access to the newly developed CHICA Type 2 Diabetes Module. The CHICA Type 2 Diabetes Module will assist pediatricians in identification of those children 10 years of age or older who are at increased risk for type 2 diabetes, it will provide pediatric physicians guidelines to screen for type 2 diabetes, and it will coordinate the diagnosis and long-term management of the condition.~CHICA Type 2 Diabetes Module: Information with regard to family history of type 2 diabetes, race/ethnicity, and maternal history of gestational diabetes will be gathered for every patient. This data will then be utilized by the CHICA system when a child is age 10 or older and presents to the clinic. Data regarding the child's BMI at that time will be analyzed by the CHICA system."
134425|NCT01814787|P2|Participant Flow|Usual Care|Those patients who are assigned to the control group will have the CHICA system but will NOT be cared for using the CHICA Type 2 Diabetes Module. The CHICA system will notify the physician of the child’s BMI percentile on the physician worksheet. However, the CHICA system will not ask for any additional information related to risk factors for type 2 diabetes on the pre-screening form, no advice will be provided to the physician on the physician worksheet, nor will just-in-time documents or automated reminder calls be made available. Identification of patients at risk for type 2 diabetes and care of those patients will occur through routine practices for that clinic.
134426|NCT01814787|P1|Participant Flow|CHICA Type 2 Diabetes Module|"Children treated at the two intervention clinic sites will have be treated using the CHICA system AND will be provided access to the newly developed CHICA Type 2 Diabetes Module. The CHICA Type 2 Diabetes Module will assist pediatricians in identification of those children 10 years of age or older who are at increased risk for type 2 diabetes, it will provide pediatric physicians guidelines to screen for type 2 diabetes, and it will coordinate the diagnosis and long-term management of the condition.~CHICA Type 2 Diabetes Module: Information with regard to family history of type 2 diabetes, race/ethnicity, and maternal history of gestational diabetes will be gathered for every patient. This data will then be utilized by the CHICA system when a child is age 10 or older and presents to the clinic. Data regarding the child's BMI at that time will be analyzed by the CHICA system. If the child's BMI > 85th percentile, a prompt will appear on the provider worksheet asking the clinician"
134427|NCT01814787|O2|Outcome|Usual Care|Those patients who are assigned to the control group will have the CHICA system but will NOT be cared for using the CHICA Type 2 Diabetes Module. The CHICA system will notify the physician of the child’s BMI percentile on the physician worksheet. However, the CHICA system will not ask for any additional information related to risk factors for type 2 diabetes on the pre-screening form, no advice will be provided to the physician on the physician worksheet, nor will just-in-time documents or automated reminder calls be made available. Identification of patients at risk for type 2 diabetes and care of those patients will occur through routine practices for that clinic.
134428|NCT01814787|O1|Outcome|CHICA Type 2 Diabetes Module|Children treated at the two intervention clinic sites will have be treated using the CHICA system AND will be provided access to the newly developed CHICA Type 2 Diabetes Module. The CHICA Type 2 Diabetes Module will assist pediatricians in identification of those children 10 years of age or older who are at increased risk for type 2 diabetes, it will provide pediatric physicians guidelines to screen for type 2 diabetes, and it will coordinate the diagnosis and long-term management of the condition.
134429|NCT01814787|E2|Reported Event|Usual Care|Those patients who are assigned to the control group will have the CHICA system but will NOT be cared for using the CHICA Type 2 Diabetes Module. The CHICA system will notify the physician of the child’s BMI percentile on the physician worksheet. However, the CHICA system will not ask for any additional information related to risk factors for type 2 diabetes on the pre-screening form, no advice will be provided to the physician on the physician worksheet, nor will just-in-time documents or automated reminder calls be made available. Identification of patients at risk for type 2 diabetes and care of those patients will occur through routine practices for that clinic.
134430|NCT01814787|E1|Reported Event|CHICA Type 2 Diabetes Module|Children treated at the two intervention clinic sites will have be treated using the CHICA system AND will be provided access to the newly developed CHICA Type 2 Diabetes Module. The CHICA Type 2 Diabetes Module will assist pediatricians in identification of those children 10 years of age or older who are at increased risk for type 2 diabetes, it will provide pediatric physicians guidelines to screen for type 2 diabetes, and it will coordinate the diagnosis and long-term management of the condition.
134431|NCT01814774|B1|Baseline|All Participants|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
134432|NCT01814774|P1|Participant Flow|All Participants|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
134433|NCT01814774|O2|Outcome|Xeomin®|Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
134434|NCT01814774|O1|Outcome|BOTOX®|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
134435|NCT01814774|O2|Outcome|Xeomin®|Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
134436|NCT01814774|O1|Outcome|BOTOX®|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
134437|NCT01814774|O2|Outcome|Xeomin®|Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
138936|NCT01791725|E1|Reported Event|ELND005 BID|"ELND005 250 mg BID~ELND005"
134439|NCT01814774|O2|Outcome|Xeomin®|Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
134440|NCT01814774|O1|Outcome|BOTOX®|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
134441|NCT01814774|E2|Reported Event|Xeomin®|Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
134442|NCT01814774|E1|Reported Event|BOTOX®|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
134443|NCT01814761|B3|Baseline|Total|Total of all reporting groups
134444|NCT01814761|B2|Baseline|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
134445|NCT01814761|B1|Baseline|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
134446|NCT01814761|P2|Participant Flow|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
134447|NCT01814761|P1|Participant Flow|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
134448|NCT01814761|O2|Outcome|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
134449|NCT01814761|O1|Outcome|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
134450|NCT01814761|O2|Outcome|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
134451|NCT01814761|O1|Outcome|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
134452|NCT01814761|O2|Outcome|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
134453|NCT01814761|O1|Outcome|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
134454|NCT01814761|O2|Outcome|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
134455|NCT01814761|O1|Outcome|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
134456|NCT01814761|E2|Reported Event|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
134457|NCT01814761|E1|Reported Event|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
134458|NCT01814748|B3|Baseline|Total|Total of all reporting groups
134459|NCT01814748|B2|Baseline|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
134460|NCT01814748|B1|Baseline|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
134461|NCT01814748|P2|Participant Flow|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
134462|NCT01814748|P1|Participant Flow|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
134463|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
134464|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
134465|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
134466|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
134467|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
134468|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
134469|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
138937|NCT01791517|B4|Baseline|Total|Total of all reporting groups
134470|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
134471|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
134472|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
134473|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
134474|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
134475|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
134476|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
134477|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
134478|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
134479|NCT01814748|E2|Reported Event|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
134480|NCT01814748|E1|Reported Event|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
134481|NCT01814722|B4|Baseline|Total|Total of all reporting groups
134482|NCT01814722|B3|Baseline|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
134483|NCT01814722|B2|Baseline|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
134484|NCT01814722|B1|Baseline|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
134485|NCT01814722|P3|Participant Flow|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
134486|NCT01814722|P2|Participant Flow|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
134487|NCT01814722|P1|Participant Flow|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
134488|NCT01814722|O3|Outcome|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
134489|NCT01814722|O2|Outcome|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
134490|NCT01814722|O1|Outcome|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
134491|NCT01814722|O3|Outcome|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
134492|NCT01814722|O2|Outcome|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
134493|NCT01814722|O1|Outcome|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
134494|NCT01814722|O3|Outcome|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
134495|NCT01814722|O2|Outcome|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
134496|NCT01814722|O1|Outcome|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
134497|NCT01814722|O3|Outcome|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
134498|NCT01814722|O2|Outcome|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
134499|NCT01814722|O1|Outcome|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
134500|NCT01814722|E3|Reported Event|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
134501|NCT01814722|E2|Reported Event|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
134502|NCT01814722|E1|Reported Event|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
134503|NCT01814696|B3|Baseline|Total|Total of all reporting groups
134504|NCT01814696|B2|Baseline|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
134505|NCT01814696|B1|Baseline|Control|Subjects will continue to receive usual medical care from their doctor(s).
134506|NCT01814696|P2|Participant Flow|Intervention|"Subjects will continue to receive usual medical care from their doctor(s).~Intervention: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
134507|NCT01814696|P1|Participant Flow|Control|"Subjects will continue to receive usual medical care from their doctor(s).~Subjects will follow their normal medication management routine."
134636|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
139704|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
134508|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
134509|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
134510|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
134511|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
134512|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
134513|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
134514|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
134515|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
134516|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
134517|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
134518|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
134519|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
134520|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
134521|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
134522|NCT01814696|E2|Reported Event|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
134523|NCT01814696|E1|Reported Event|Control|Subjects will continue to receive usual medical care from their doctor(s).
134524|NCT01814670|B1|Baseline|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
134525|NCT01814670|P1|Participant Flow|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
134526|NCT01814670|O1|Outcome|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
134527|NCT01814670|O1|Outcome|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
134528|NCT01814670|O1|Outcome|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
134529|NCT01814670|O1|Outcome|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
134530|NCT01814670|O1|Outcome|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
134531|NCT01814670|E1|Reported Event|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
134532|NCT01814553|B3|Baseline|Total|Total of all reporting groups
134533|NCT01814553|B2|Baseline|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
134534|NCT01814553|B1|Baseline|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
134535|NCT01814553|P2|Participant Flow|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
134536|NCT01814553|P1|Participant Flow|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
134537|NCT01814553|O2|Outcome|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
134538|NCT01814553|O1|Outcome|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
134539|NCT01814553|O2|Outcome|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
134540|NCT01814553|O1|Outcome|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
134541|NCT01814553|O2|Outcome|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
134542|NCT01814553|O1|Outcome|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
134543|NCT01814553|O2|Outcome|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
134544|NCT01814553|O1|Outcome|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
134545|NCT01814553|O2|Outcome|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
134546|NCT01814553|O1|Outcome|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
134547|NCT01814553|E2|Reported Event|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
134637|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
157777|NCT01717989|O2|Outcome|Q1 2011|First quarter (Q1), 2011
134548|NCT01814553|E1|Reported Event|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
134549|NCT01814397|B1|Baseline|Women Starting Aromatase Inhibitor (AI) Therapy|There is only a single cohort. Postmenopausal women with estrogen receptor positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
134550|NCT01814397|P1|Participant Flow|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with hormone receptor positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
134551|NCT01814397|O1|Outcome|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with ER positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
134552|NCT01814397|O1|Outcome|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with ER positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
134553|NCT01814397|O1|Outcome|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with ER positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
134554|NCT01814397|O1|Outcome|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with ER positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
134555|NCT01814397|E1|Reported Event|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with ER positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
134556|NCT01814332|B3|Baseline|Total|Total of all reporting groups
134557|NCT01814332|B2|Baseline|Placebo|"Placebo compound treatment for comparison with IP~Placebo: Placebo compound treatment for comparison with IP"
134558|NCT01814332|B1|Baseline|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration~GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
134559|NCT01814332|P2|Participant Flow|Placebo|"Placebo compound treatment for comparison with IP~Placebo: Placebo compound treatment for comparison with IP"
134560|NCT01814332|P1|Participant Flow|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration~GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
134561|NCT01814332|O2|Outcome|Placebo|"Placebo compound treatment for comparison with IP~Placebo: Placebo compound treatment for comparison with IP"
134562|NCT01814332|O1|Outcome|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration~GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
134563|NCT01814332|O2|Outcome|Placebo|"Placebo compound treatment for comparison with IP~Placebo: Placebo compound treatment for comparison with IP"
134564|NCT01814332|O1|Outcome|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration~GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
134565|NCT01814332|O2|Outcome|Placebo|"Placebo compound treatment for comparison with IP~Placebo: Placebo compound treatment for comparison with IP"
134566|NCT01814332|O1|Outcome|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration~GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
134567|NCT01814332|O2|Outcome|Placebo|"Placebo compound treatment for comparison with IP~Placebo: Placebo compound treatment for comparison with IP"
134568|NCT01814332|O1|Outcome|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration~GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
134569|NCT01814332|E2|Reported Event|Placebo|"Placebo compound treatment for comparison with IP~Placebo: Placebo compound treatment for comparison with IP"
134570|NCT01814332|E1|Reported Event|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration~GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
134571|NCT01814241|B1|Baseline|Open Label Peanut OIT|Open label orally ingested peanut flour with maintenance dose of 1450mg
134572|NCT01814241|P1|Participant Flow|Open Label Peanut OIT|Open label orally ingested peanut flour with maintenance dose of 1450mg
134573|NCT01814241|O1|Outcome|Open Label Peanut OIT|Subject cohort receiving open label orally ingested peanut flour with maintenance dose of 1450mg
134574|NCT01814241|O1|Outcome|Open Label Peanut OIT|Subject cohort receiving open label orally ingested peanut flour with maintenance dose of 1450mg
134575|NCT01814241|O1|Outcome|Open Label Peanut OIT|Open label orally ingested peanut flour with maintenance dose of 1450mg
134576|NCT01814241|O1|Outcome|Open Label Peanut OIT|Open label orally ingested peanut flour with maintenance dose of 1450mg
134577|NCT01814241|O1|Outcome|Open Label Peanut OIT|Open label orally ingested peanut flour with maintenance dose of 1450mg
134578|NCT01814241|E1|Reported Event|Open Label Peanut OIT|Open label orally ingested peanut flour with maintenance dose of 1450mg
134579|NCT01814137|B3|Baseline|Total|Total of all reporting groups
134604|NCT01814046|O2|Outcome|Cells and no High Dose Aldesleukin|"Patients receiving cells and no high dose aldesleukin~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Young TIL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
139705|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
134580|NCT01814137|B2|Baseline|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
134581|NCT01814137|B1|Baseline|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
134582|NCT01814137|P2|Participant Flow|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
134583|NCT01814137|P1|Participant Flow|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
134584|NCT01814137|O2|Outcome|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
134585|NCT01814137|O1|Outcome|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
134586|NCT01814137|O2|Outcome|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
134629|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
134630|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
134631|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
134587|NCT01814137|O1|Outcome|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
134588|NCT01814137|O2|Outcome|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
134589|NCT01814137|O1|Outcome|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
134590|NCT01814137|O2|Outcome|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
134591|NCT01814137|O1|Outcome|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
134592|NCT01814137|O2|Outcome|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
134593|NCT01814137|O1|Outcome|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
134632|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
134633|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
134634|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
157778|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter (Q4) 2010
134594|NCT01814137|E2|Reported Event|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
134595|NCT01814137|E1|Reported Event|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
134596|NCT01814046|B3|Baseline|Total|Total of all reporting groups
134597|NCT01814046|B2|Baseline|Cells and no High Dose Aldesleukin|"Patients receiving cells and no high dose aldesleukin~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Young TIL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
134598|NCT01814046|B1|Baseline|Cells + High Dose Aldesleukin|"Patients receiving cells + high dose aldesleukin~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses) (only for cohort A).~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Young tumor infiltrating lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
134599|NCT01814046|P3|Participant Flow|Cells + High-Dose Aldesleukin Retreatment|Patients experiencing a sustained stable disease, partial or complete response may receive a second treatment when progression by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria is documented after evaluation by the principal investigator. Retreatment will consist of the same regimen that they had been given safely previously.
134600|NCT01814046|P2|Participant Flow|Cells and no High Dose Aldesleukin|"Patients receiving cells and no high dose aldesleukin~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Young TIL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
134601|NCT01814046|P1|Participant Flow|Cells + High Dose Aldesleukin|"Patients receiving cells + high dose aldesleukin~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses) (only for cohort A).~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Young tumor infiltrating lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
134602|NCT01814046|O2|Outcome|Cells and no High Dose Aldesleukin|"Patients receiving cells and no high dose aldesleukin~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Young TIL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
134603|NCT01814046|O1|Outcome|Cells + High Dose Aldesleukin|"Patients receiving cells + high dose aldesleukin~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses) (only for cohort A).~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Young tumor infiltrating lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
134605|NCT01814046|O1|Outcome|Cells + High Dose Aldesleukin|"Patients receiving cells + high dose aldesleukin~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses) (only for cohort A).~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Young tumor infiltrating lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
134606|NCT01814046|O2|Outcome|Cells and no High Dose Aldesleukin|"Patients receiving cells and no high dose aldesleukin~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Young TIL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
134607|NCT01814046|O1|Outcome|Cells + High Dose Aldesleukin|"Patients receiving cells + high dose aldesleukin~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses) (only for cohort A).~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Young tumor infiltrating lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
134608|NCT01814046|E3|Reported Event|Cells + High-Dose Aldesleukin Retreatment|Patients experiencing a sustained stable disease, partial or complete response may receive a second treatment when progression by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria is documented after evaluation by the principal investigator. Retreatment will consist of the same regimen that they had been given safely previously.
134609|NCT01814046|E2|Reported Event|Cells and No High-Dose Aldesleukin|"Patients receiving cells and no high dose aldesleukin~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Young TIL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
134610|NCT01814046|E1|Reported Event|Cells + High-Dose Aldesleukin|"Patients receiving cells + high dose aldesleukin~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses) (only for cohort A).~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Young tumor infiltrating lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
134611|NCT01813890|B4|Baseline|Total|Total of all reporting groups
134612|NCT01813890|B3|Baseline|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
134613|NCT01813890|B2|Baseline|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
134614|NCT01813890|B1|Baseline|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
134615|NCT01813890|P3|Participant Flow|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
134616|NCT01813890|P2|Participant Flow|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
134617|NCT01813890|P1|Participant Flow|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
134618|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
134619|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
134620|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
134621|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
134622|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
134623|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
134624|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
134625|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
134626|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
134627|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
134628|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
134638|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
134639|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
134640|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
134641|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
134642|NCT01813890|E3|Reported Event|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
134643|NCT01813890|E2|Reported Event|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
134644|NCT01813890|E1|Reported Event|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
134645|NCT01813721|B1|Baseline|Primary Analysis Set|
134646|NCT01813721|P1|Participant Flow|All Enrolled Patients|Participants with cancer who were planning to receive standard dose chemotherapy regimens with a documented intermediate risk (10% to 20%) of febrile neutropenia (FN).
134647|NCT01813721|O1|Outcome|At or Above Investigator Threshold|
134648|NCT01813721|O4|Outcome|Small Cell Lung Cancer|
134649|NCT01813721|O3|Outcome|Non-Hodgkin's Lymphoma|
134650|NCT01813721|O2|Outcome|Non-small Cell Lung Cancer|
134651|NCT01813721|O1|Outcome|Breast Cancer|
134652|NCT01813721|O4|Outcome|Comprehensive Cancer Center|
134653|NCT01813721|O3|Outcome|Private Center|
134654|NCT01813721|O2|Outcome|General Hospital|
134655|NCT01813721|O1|Outcome|University Hospital|
134656|NCT01813721|O2|Outcome|> 10 Years|
134657|NCT01813721|O1|Outcome|≤ 10 Years|
134658|NCT01813721|O2|Outcome|Hematologist|
134659|NCT01813721|O1|Outcome|Medical Oncologist|
134660|NCT01813721|O4|Outcome|France|
134661|NCT01813721|O3|Outcome|Romania|
134662|NCT01813721|O2|Outcome|Greece|
134663|NCT01813721|O1|Outcome|Poland|
134664|NCT01813721|O2|Outcome|General Hospital|
134665|NCT01813721|O1|Outcome|University Hospital|
134666|NCT01813721|O2|Outcome|> 10 Years|
134667|NCT01813721|O1|Outcome|≤ 10 Years|
134668|NCT01813721|O1|Outcome|Medical Oncologist|
134669|NCT01813721|O4|Outcome|Small Cell Lung Cancer|
134670|NCT01813721|O3|Outcome|Non-Hodgkin's Lymphoma|
134671|NCT01813721|O2|Outcome|Non-small Cell Lung Cancer|
134672|NCT01813721|O1|Outcome|Breast Cancer|
134673|NCT01813721|O4|Outcome|Comprehensive Cancer Center|
134674|NCT01813721|O3|Outcome|Private Center|
134675|NCT01813721|O2|Outcome|General Hospital|
134676|NCT01813721|O1|Outcome|University Hospital|
134677|NCT01813721|O2|Outcome|> 10 Years|
134678|NCT01813721|O1|Outcome|≤ 10 Years|
134679|NCT01813721|O2|Outcome|Hematologist|
134680|NCT01813721|O1|Outcome|Medical Oncologist|
134681|NCT01813721|O4|Outcome|France|
134682|NCT01813721|O3|Outcome|Romania|
134683|NCT01813721|O2|Outcome|Greece|
134684|NCT01813721|O1|Outcome|Poland|
134685|NCT01813721|O1|Outcome|Primary Analysis Set|
134686|NCT01813721|O2|Outcome|General Hospital|
134687|NCT01813721|O1|Outcome|University Hospital|
134688|NCT01813721|O2|Outcome|> 10 Years|
134689|NCT01813721|O1|Outcome|≤ 10 Years|
134690|NCT01813721|O1|Outcome|Medical Oncologist|
134691|NCT01813721|O1|Outcome|Primary Analysis Set - Investigators|
134692|NCT01813721|O1|Outcome|Primary Analysis Set|
134693|NCT01813721|O1|Outcome|Primary Analysis Set|
134694|NCT01813721|O1|Outcome|Primary Analysis Set - Investigators|
134695|NCT01813721|O1|Outcome|Primary Analysis Set - Investigators|
134696|NCT01813721|E1|Reported Event|All Enrolled Patients|Participants with cancer who were planning to receive standard dose chemotherapy regimens with a documented intermediate risk (10% to 20%) of febrile neutropenia (FN).
134697|NCT01813474|B4|Baseline|Total|Total of all reporting groups
134698|NCT01813474|B3|Baseline|300 mg Bid, Expansion Part|Olaparib tablet 300 mg bid, 600 mg/day, expansion part
134699|NCT01813474|B2|Baseline|300 mg Bid, Dose Escalation Part|Olaparib table 300 mg bid, 600 mg/day, dose escalation part
134700|NCT01813474|B1|Baseline|200 mg Bid, Dose Escalation Part|Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
134701|NCT01813474|P3|Participant Flow|300 mg Bid, Expansion Part|Olaparib tablet 300 mg bid, 600 mg/day, expansion part
134702|NCT01813474|P2|Participant Flow|300 mg Bid, Dose Escalation Part|Olaparib table 300 mg bid, 600 mg/day, dose escalation part
134703|NCT01813474|P1|Participant Flow|200 mg Bid, Dose Escalation Part|Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
134704|NCT01813474|O2|Outcome|300 mg Bid, Dose Escalation Part|Olaparib table 300 mg bid, 600 mg/day, dose escalation part
134705|NCT01813474|O1|Outcome|200 mg Bid, Dose Escalation Part|Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
134706|NCT01813474|O2|Outcome|300 mg Bid, Dose Escalation Part|Olaparib table 300 mg bid, 600 mg/day, dose escalation part
134707|NCT01813474|O1|Outcome|200 mg Bid, Dose Escalation Part|Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
134708|NCT01813474|O2|Outcome|300 mg Bid, Dose Escalation Part|Olaparib table 300 mg bid, 600 mg/day, dose escalation part
134709|NCT01813474|O1|Outcome|200 mg Bid, Dose Escalation Part|Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
134710|NCT01813474|O2|Outcome|300 mg Bid, Dose Escalation Part|Olaparib table 300 mg bid, 600 mg/day, dose escalation part
134711|NCT01813474|O1|Outcome|200 mg Bid, Dose Escalation Part|Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
134712|NCT01813474|O2|Outcome|300 mg Bid, Dose Escalation Part|Olaparib table 300 mg bid, 600 mg/day, dose escalation part
134713|NCT01813474|O1|Outcome|200 mg Bid, Dose Escalation Part|Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
134714|NCT01813474|O2|Outcome|300 mg Bid, Dose Escalation Part|Olaparib table 300 mg bid, 600 mg/day, dose escalation part
134715|NCT01813474|O1|Outcome|200 mg Bid, Dose Escalation Part|Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
134716|NCT01813474|O2|Outcome|300 mg Bid, Dose Escalation Part|Olaparib tablet 300 mg bid, 600 mg/day, dose escalation part
134717|NCT01813474|O1|Outcome|200 mg Bid, Dose Escalation Part|Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
134718|NCT01813474|O3|Outcome|300 mg Bid, Expansion Part|Olaparib tablet 300 mg bid, 600 mg/day, expansion part
134719|NCT01813474|O2|Outcome|300 mg Bid, Dose Escalation Part|Olaparib table 300 mg bid, 600 mg/day, dose escalation part
134720|NCT01813474|O1|Outcome|200 mg Bid, Dose Escalation Part|Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
134721|NCT01813474|E3|Reported Event|300 mg Bid, Expansion Part|Olaparib tablet 300 mg bid, 600 mg/day, expansion part
134722|NCT01813474|E2|Reported Event|300 mg Bid, Dose Escalation Part|Olaparib table 300 mg bid, 600 mg/day, dose escalation part
134723|NCT01813474|E1|Reported Event|200 mg Bid, Dose Escalation Part|Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
134724|NCT01813422|B3|Baseline|Total|Total of all reporting groups
134725|NCT01813422|B2|Baseline|Evolocumab|Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.
134726|NCT01813422|B1|Baseline|Placebo|Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
134727|NCT01813422|P2|Participant Flow|Evolocumab|Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.
134728|NCT01813422|P1|Participant Flow|Placebo|Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
134729|NCT01813422|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.
134730|NCT01813422|O1|Outcome|Placebo|Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
134731|NCT01813422|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.
134732|NCT01813422|O1|Outcome|Placebo|Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
134733|NCT01813422|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.
134734|NCT01813422|O1|Outcome|Placebo|Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
134735|NCT01813422|O2|Outcome|Evolocumab|Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.
134736|NCT01813422|O1|Outcome|Placebo|Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
134737|NCT01813422|E2|Reported Event|Evolocumab|Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.
134738|NCT01813422|E1|Reported Event|Placebo|Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
134739|NCT01813110|B1|Baseline|Baseline|Baseline (prior to placebo or omega-3 supplementation)
134740|NCT01813110|P2|Participant Flow|Omega-3 Fatty Acids (8 Weeks), Then Placebo (8 Weeks)|8 weeks of omega-3 fatty acid supplementation (4 g prescription omega-3 fatty acid concentrate) followed by 8 weeks of placebo (olive oil) supplementation
134741|NCT01813110|P1|Participant Flow|Placebo (8 Weeks), Then Omega-3 Fatty Acids (8 Weeks)|8 weeks of placebo (olive oil) supplementation followed by 8 weeks of omega-3 fatty acid supplementation (4 g prescription omega-3 fatty acid concentrate)
134742|NCT01813110|O2|Outcome|Omega-3 Fatty Acids (8 Weeks)|8 weeks of omega-3 fatty acid supplementation (4 g prescription omega-3 fatty acid concentrate) prior to low-dose endotoxin challenge
134743|NCT01813110|O1|Outcome|Placebo (8 Weeks)|8 weeks of placebo (olive oil) supplementation prior to low-dose endotoxin challenge
134744|NCT01813110|O2|Outcome|Omega-3 Fatty Acids (8 Weeks)|8 weeks of omega-3 fatty acid supplementation (4 g prescription omega-3 fatty acid concentrate) prior to low-dose endotoxin challenge
134745|NCT01813110|O1|Outcome|Placebo (8 Weeks)|8 weeks of placebo (olive oil) supplementation prior to low-dose endotoxin challenge
134746|NCT01813110|O2|Outcome|Omega-3 Fatty Acids (8 Weeks)|8 weeks of omega-3 fatty acid supplementation (4 g prescription omega-3 fatty acid concentrate) prior to low-dose endotoxin challenge
134747|NCT01813110|O1|Outcome|Placebo (8 Weeks)|8 weeks of placebo (olive oil) supplementation prior to low-dose endotoxin challenge
134748|NCT01813110|E2|Reported Event|Omega-3, Placebo|8 weeks of omega-3 fatty acid supplementation (4 g prescription omega-3 fatty acid concentrate) followed by 8 weeks of placebo (olive oil) supplementation
134749|NCT01813110|E1|Reported Event|Placebo, Omega-3|8 weeks of placebo (olive oil) supplementation followed by 8 weeks of omega-3 fatty acid supplementation (4 g prescription omega-3 fatty acid concentrate
134750|NCT01813019|B3|Baseline|Total|Total of all reporting groups
134751|NCT01813019|B2|Baseline|AFQ056|AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
134752|NCT01813019|B1|Baseline|Placebo|Matching Placebo b.i.d. dosing
134753|NCT01813019|P2|Participant Flow|AFQ056|AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
134754|NCT01813019|P1|Participant Flow|Placebo|Matching Placebo b.i.d. dosing
134755|NCT01813019|O2|Outcome|AFQ056|AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
134756|NCT01813019|O1|Outcome|Placebo|Matching Placebo b.i.d. dosing
134757|NCT01813019|O2|Outcome|AFQ056|AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
134758|NCT01813019|O1|Outcome|Placebo|Matching Placebo b.i.d. dosing
134867|NCT01812057|O2|Outcome|Placebo|Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. ...
134759|NCT01813019|E2|Reported Event|AFQ056|AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
134760|NCT01813019|E1|Reported Event|Placebo|Matching Placebo b.i.d. dosing
134761|NCT01812837|B4|Baseline|Total|Total of all reporting groups
134762|NCT01812837|B3|Baseline|60 Minute Microneedle Pretreatment Incubation|"60 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
134763|NCT01812837|B2|Baseline|40 Minute Microneedle Pretreatment Incubation|"40 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
134764|NCT01812837|B1|Baseline|20 Minute Microneedle Pretreatment Incubation|"20 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
134765|NCT01812837|P3|Participant Flow|60 Minute Microneedle Pretreatment Incubation|"60 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
134766|NCT01812837|P2|Participant Flow|40 Minute Microneedle Pretreatment Incubation|"40 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
134767|NCT01812837|P1|Participant Flow|20 Minute Microneedle Pretreatment Incubation|"20 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
134768|NCT01812837|O3|Outcome|60 Minute Microneedle Pretreatment Incubation|"60 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
134769|NCT01812837|O2|Outcome|40 Minute Microneedle Pretreatment Incubation|"40 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
134770|NCT01812837|O1|Outcome|20 Minute Microneedle Pretreatment Incubation|"20 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
134771|NCT01812837|E3|Reported Event|60 Minute Microneedle Pretreatment Incubation|"60 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
134772|NCT01812837|E2|Reported Event|40 Minute Microneedle Pretreatment Incubation|"40 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
134773|NCT01812837|E1|Reported Event|20 Minute Microneedle Pretreatment Incubation|"20 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
134774|NCT01812707|B5|Baseline|Total|Total of all reporting groups
134775|NCT01812707|B4|Baseline|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134776|NCT01812707|B3|Baseline|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134777|NCT01812707|B2|Baseline|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134778|NCT01812707|B1|Baseline|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
134779|NCT01812707|P4|Participant Flow|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134780|NCT01812707|P3|Participant Flow|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134781|NCT01812707|P2|Participant Flow|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134782|NCT01812707|P1|Participant Flow|Placebo|Placebo (for alirocumab) every 2 weeks (Q2W) for 12-weeks in combination with atorvastatin stable dose.
134783|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134784|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134785|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134786|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12 weeks in combination with atorvastatin stable dose.
134787|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134788|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134789|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134790|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
134791|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134792|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134793|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134794|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
134795|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134796|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134797|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134798|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
134799|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134800|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134801|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134802|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
134803|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134804|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134805|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134806|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
134807|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134808|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134809|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134810|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
134811|NCT01812707|E4|Reported Event|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134812|NCT01812707|E3|Reported Event|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134813|NCT01812707|E2|Reported Event|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
134814|NCT01812707|E1|Reported Event|Placebo|Placebo Q2W for 12 weeks in combination with atorvastatin stable dose.
134815|NCT01812681|B3|Baseline|Total|Total of all reporting groups
134816|NCT01812681|B2|Baseline|Normal Vitamin D|The premature infants with normal vitamin D level
134817|NCT01812681|B1|Baseline|Low Vitamin D Level|The premature infants with low cord blood vitamin D level
134818|NCT01812681|P2|Participant Flow|Normal Vitamin D|The premature infants with normal vitamin D level
134819|NCT01812681|P1|Participant Flow|Low Vitamin D Level|The premature infants with low cord blood vitamin D level
134820|NCT01812681|O2|Outcome|Normal Vitamin D|The premature infants with normal vitamin D level
134821|NCT01812681|O1|Outcome|Low Vitamin D Level|The premature infants with low cord blood vitamin D level
134822|NCT01812681|O2|Outcome|Normal Vitamin D|The premature infants with normal vitamin D level
134823|NCT01812681|O1|Outcome|Low Vitamin D Level|The premature infants with low cord blood vitamin D level
134824|NCT01812681|E2|Reported Event|Normal Vitamin D|The premature infants with normal vitamin D level
134825|NCT01812681|E1|Reported Event|Low Vitamin D Level|The premature infants with low cord blood vitamin D level
134826|NCT01812655|B4|Baseline|Total|Total of all reporting groups
134827|NCT01812655|B3|Baseline|Standard Care Provided by the Nurses|
134828|NCT01812655|B2|Baseline|Passive Distraction|watching a movie
134829|NCT01812655|B1|Baseline|Virtual Reality|Virtual reality using a software program designed for burn patients during burn wound care
134830|NCT01812655|P3|Participant Flow|SC Provided by the Nurses|Nurses provided their usual, standard care throughout the entire burn wound care, such as talking with the patients. Mean time for the intervention use was 49.0 minutes.
134831|NCT01812655|P2|Participant Flow|Passive Distraction|Patients watched a movie, Cloudy with a Chance of Meatballs, throughout their burn wound care to offer passive distraction from wound care pain. Mean time for the intervention use was 31.6 minutes.
134868|NCT01812057|O1|Outcome|Dexamethasone|Dexamethasone 8 mg IV given intraoperatively as a one-time dose. ...
134869|NCT01812057|O2|Outcome|Placebo|Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. ...
134832|NCT01812655|P1|Participant Flow|Virtual Reality|Patients were distracted from their burn wound care pain throughout their entire burn wound care procedure using an interactive virtual reality program designed for burn patients. Mean time for the intervention was 31.6 minutes.
134833|NCT01812655|O3|Outcome|SC Provided by the Nurses|Nurses provided their usual, standard care throughout the entire burn wound care, such as talking with the patients. Mean time for the intervention use was 49.0 minutes.
134834|NCT01812655|O2|Outcome|Passive Distraction|Patients watched a movie, Cloudy with a Chance of Meatballs, throughout their burn wound care to offer passive distraction from wound care pain. Mean time for the intervention use was 31.6 minutes.
134835|NCT01812655|O1|Outcome|Virtual Reality|Patients were distracted from their burn wound care pain throughout their entire burn wound care procedure using an interactive virtual reality program designed for burn patients. Mean time for the intervention was 31.6 minutes.
134836|NCT01812655|O3|Outcome|SC Provided by the Nurses|Nurses provided their usual, standard care throughout the entire burn wound care, such as talking with the patients. Mean time for the intervention use was 49.0 minutes.
134837|NCT01812655|O2|Outcome|Passive Distraction|Patients watched a movie, Cloudy with a Chance of Meatballs, throughout their burn wound care to offer passive distraction from wound care pain. Mean time for the intervention use was 31.6 minutes.
134838|NCT01812655|O1|Outcome|Virtual Reality|Patients were distracted from their burn wound care pain throughout their entire burn wound care procedure using an interactive virtual reality program designed for burn patients. Mean time for the intervention was 31.6 minutes.
134839|NCT01812655|O3|Outcome|Standard Care Provided by the Nurses|
134840|NCT01812655|O2|Outcome|Passive Distraction|watching a movie
134841|NCT01812655|O1|Outcome|Virtual Reality|Virtual reality using a software program designed for burn patients during burn wound care
134842|NCT01812655|E3|Reported Event|UC Provided by the Nurses|
134843|NCT01812655|E2|Reported Event|Passive Distraction|watching a movie
134844|NCT01812655|E1|Reported Event|Virtual Reality|Virtual reality using a software program designed for burn patients during burn wound care
134845|NCT01812473|B3|Baseline|Total|Total of all reporting groups
134846|NCT01812473|B2|Baseline|Patients Admitted to the ICU Treated With Voriconazole|Patients admitted to the Intensive Care Unit, treated with voriconazole are included in this study. Voriconazole protein binding will be determined and the correlation with albumin plasma concentrations will be evaluated.
134847|NCT01812473|B1|Baseline|Patients Admitted Tot the ICU Not Treated With Voriconazole|"Patients admitted to the intensive Care Unit, with varying levels of plasma albumin concentrations during admission.~Plasma from this patients will be spiked in vitro with different voriconazole concentrations to investigate the influence of low albumine concentrations in plasma on voriconazole protein binding characteristics."
134848|NCT01812473|P2|Participant Flow|Patients Admitted to the ICU Treated With Voriconazole|Patients admitted to the Intensive Care Unit, treated with voriconazole are included in this study. Voriconazole protein binding will be determined and the correlation with albumin plasma concentrations will be evaluated.
134849|NCT01812473|P1|Participant Flow|Patients Admitted to the ICU Not Treated With Voriconazole|"Patients admitted to the intensive Care Unit, with varying levels of plasma albumin concentrations during admission.~Plasma from this patients will be spiked in vitro with different voriconazole concentrations to investigate the influence of low albumine concentrations in plasma on voriconazole protein binding characteristics."
134850|NCT01812473|O2|Outcome|Patients Admitted to the ICU Treated With Voriconazole|Patients admitted to the Intensive Care Unit, treated with voriconazole are included in this study. Voriconazole protein binding will be determined and the correlation with albumin plasma concentrations will be evaluated.
134851|NCT01812473|O1|Outcome|Patients Admitted Tot the ICU Not Treated With Voriconazole|"Patients admitted to the intensive Care Unit, with varying levels of plasma albumin concentrations during admission.~Plasma from this patients will be spiked in vitro with different voriconazole concentrations to investigate the influence of low albumine concentrations in plasma on voriconazole protein binding characteristics."
134852|NCT01812473|E2|Reported Event|Patients Admitted to the ICU Treated With Voriconazole|Patients admitted to the Intensive Care Unit, treated with voriconazole are included in this study. Voriconazole protein binding will be determined and the correlation with albumin plasma concentrations will be evaluated.
134853|NCT01812473|E1|Reported Event|Patients Admitted Tot the ICU Not Treated With Voriconazole|"Patients admitted to the intensive Care Unit, with varying levels of plasma albumin concentrations during admission.~Plasma from this patients will be spiked in vitro with different voriconazole concentrations to investigate the influence of low albumine concentrations in plasma on voriconazole protein binding characteristics."
134854|NCT01812057|B3|Baseline|Total|Total of all reporting groups
134855|NCT01812057|B2|Baseline|Placebo|"Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.~Placebo: Sodium Chloride 0.9% -5 ml"
134856|NCT01812057|B1|Baseline|Dexamethasone|"Dexamethasone 8 mg IV given intraoperatively as a one-time dose.~Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)"
134857|NCT01812057|P2|Participant Flow|Placebo|"Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.~Placebo: Sodium Chloride 0.9% -5 ml"
134858|NCT01812057|P1|Participant Flow|Dexamethasone|"Dexamethasone 8 mg IV given intraoperatively as a one-time dose.~Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)"
134859|NCT01812057|O2|Outcome|Placebo|"Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.~Placebo: Sodium Chloride 0.9% -5 ml"
134860|NCT01812057|O1|Outcome|Dexamethasone|"Dexamethasone 8 mg IV given intraoperatively as a one-time dose.~Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)"
134861|NCT01812057|O2|Outcome|Placebo|Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. ...
134862|NCT01812057|O1|Outcome|Dexamethasone|Dexamethasone 8 mg IV given intraoperatively as a one-time dose. ...
134863|NCT01812057|O2|Outcome|Placebo|Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. ...
134864|NCT01812057|O1|Outcome|Dexamethasone|Dexamethasone 8 mg IV given intraoperatively as a one-time dose. ...
134865|NCT01812057|O2|Outcome|Placebo|Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. ...
134866|NCT01812057|O1|Outcome|Dexamethasone|Dexamethasone 8 mg IV given intraoperatively as a one-time dose. ...
134870|NCT01812057|O1|Outcome|Dexamethasone|Dexamethasone 8 mg IV given intraoperatively as a one-time dose. ...
134871|NCT01812057|O2|Outcome|Placebo|Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. ...
134872|NCT01812057|O1|Outcome|Dexamethasone|Dexamethasone 8 mg IV given intraoperatively as a one-time dose. ...
134873|NCT01812057|O2|Outcome|Negative MTS Score|Negative MTS score is defines as change of less than or equal to 1 in MTS scores between 1st tap and 11th tap.
134874|NCT01812057|O1|Outcome|Positive MTS Score|Positive MTS score is defined as change of >1 in MTS score between 1st tap and 11th tap of 180 gram von Frey filament.
134875|NCT01812057|O2|Outcome|Placebo|Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. ...
134876|NCT01812057|O1|Outcome|Dexamethasone|Dexamethasone 8 mg IV given intraoperatively as a one-time dose. ...
134877|NCT01812057|O2|Outcome|Placebo|Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. ...
134878|NCT01812057|O1|Outcome|Dexamethasone|Dexamethasone 8 mg IV given intraoperatively as a one-time dose. ...
134879|NCT01812057|O2|Outcome|Negative MTS Score|Negative MTS score is defines as change of less than or equal to 1 in MTS scores between 1st tap and 11th tap.
134880|NCT01812057|O1|Outcome|Positive MTS Score|Positive MTS score is defined as change of >1 in MTS score between 1st tap and 11th tap of 180 gram von Frey filament.
134881|NCT01812057|O2|Outcome|Placebo|"Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.~Placebo: Sodium Chloride 0.9% -5 ml"
134882|NCT01812057|O1|Outcome|Dexamethasone|"Dexamethasone 8 mg IV given intraoperatively as a one-time dose.~Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)"
134883|NCT01812057|O2|Outcome|Placebo|"Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.~Placebo: Sodium Chloride 0.9% -5 ml"
134884|NCT01812057|O1|Outcome|Dexamethasone|"Dexamethasone 8 mg IV given intraoperatively as a one-time dose.~Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)"
134885|NCT01812057|O2|Outcome|Placebo|"Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.~Placebo: Sodium Chloride 0.9% -5 ml"
134886|NCT01812057|O1|Outcome|Dexamethasone|"Dexamethasone 8 mg IV given intraoperatively as a one-time dose.~Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)"
134887|NCT01812057|O2|Outcome|Placebo|"Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.~Placebo: Sodium Chloride 0.9% -5 ml"
134888|NCT01812057|O1|Outcome|Dexamethasone|"Dexamethasone 8 mg IV given intraoperatively as a one-time dose.~Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)"
134889|NCT01812057|O2|Outcome|Placebo|"Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.~Placebo: Sodium Chloride 0.9% -5 ml"
134890|NCT01812057|O1|Outcome|Dexamethasone|"Dexamethasone 8 mg IV given intraoperatively as a one-time dose.~Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)"
134891|NCT01812057|O2|Outcome|Placebo|"Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.~Placebo: Sodium Chloride 0.9% -5 ml"
134892|NCT01812057|O1|Outcome|Dexamethasone|"Dexamethasone 8 mg IV given intraoperatively as a one-time dose.~Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)"
134893|NCT01812057|E2|Reported Event|Placebo|"Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.~Placebo: Sodium Chloride 0.9% -5 ml"
134894|NCT01812057|E1|Reported Event|Dexamethasone|"Dexamethasone 8 mg IV given intraoperatively as a one-time dose.~Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)"
134895|NCT01812044|B4|Baseline|Total|Total of all reporting groups
134896|NCT01812044|B3|Baseline|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
134897|NCT01812044|B2|Baseline|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
134898|NCT01812044|B1|Baseline|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
134899|NCT01812044|P3|Participant Flow|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
134900|NCT01812044|P2|Participant Flow|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
134901|NCT01812044|P1|Participant Flow|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
134902|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
134920|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
134903|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
134904|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
134905|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
134906|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
134907|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
134908|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
134909|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
134910|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
134911|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
134912|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
134913|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
134914|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
134915|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
134916|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
134917|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
134918|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
134919|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
134975|NCT01811953|O3|Outcome|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
134921|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
134922|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
134923|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
134924|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
134925|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
134926|NCT01812044|E3|Reported Event|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
134927|NCT01812044|E2|Reported Event|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
134928|NCT01812044|E1|Reported Event|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
134929|NCT01811953|B7|Baseline|Total|Total of all reporting groups
134930|NCT01811953|B6|Baseline|Low Dose Emp: Emp+Met / Emp/Met|"free dose combination tablets under fed conditions first; then fixed-dose-combination tablet under fed conditions~Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
134931|NCT01811953|B5|Baseline|Low Dose Emp: Emp/Met / Emp+Met|"fixed-dose-combination tablet under fed conditions first; then free dose combination tablets under fed conditions~Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
134932|NCT01811953|B4|Baseline|Emp+Met Fed / Emp/Met Fed / Emp+Met Fasted / Emp/Met Fasted|"free dose combination tablets under fed conditions first; then FDC tablet under fed conditions; then free dose combination tablets under fasted conditions; then fixed-dose-combination (FDC) tablet under fasted conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
134933|NCT01811953|B3|Baseline|Emp+Met Fasted / Emp/Met Fasted / Emp+Met Fed / Emp/Met Fed|"free dose combination tablets under fasted conditions first; then fixed-dose-combination (FDC) tablet under fasted conditions; then free dose combination tablets under fed conditions; then FDC tablet under fed conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
134934|NCT01811953|B2|Baseline|Emp/Met Fed / Emp+Met Fed / Emp/Met Fasted / Emp+Met Fasted|"fixed-dose-combination (FDC) tablet under fed conditions first; then free dose combination tablets under fed conditions; then FDC tablet under fasted conditions; then free dose combination tablets under fasted conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
134935|NCT01811953|B1|Baseline|Emp/Met Fasted / Emp+Met Fasted / Emp/Met Fed / Emp+Met Fed|"fixed-dose-combination (FDC) tablet under fasted conditions first; then free dose combination tablets under fasted conditions; then FDC tablet under fed conditions; then free dose combination tablets under fed conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
134936|NCT01811953|P6|Participant Flow|Low Dose Emp: Emp+Met / Emp/Met|"free dose combination tablets under fed conditions first; then fixed-dose-combination tablet under fed conditions~Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
134937|NCT01811953|P5|Participant Flow|Low Dose Emp: Emp/Met / Emp+Met|"fixed-dose-combination tablet under fed conditions first; then free dose combination tablets under fed conditions~Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
134938|NCT01811953|P4|Participant Flow|Emp+Met Fed / Emp/Met Fed / Emp+Met Fasted / Emp/Met Fasted|"free dose combination tablets under fed conditions first; then FDC tablet under fed conditions; then free dose combination tablets under fasted conditions; then fixed-dose-combination (FDC) tablet under fasted conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
134939|NCT01811953|P3|Participant Flow|Emp+Met Fasted / Emp/Met Fasted / Emp+Met Fed / Emp/Met Fed|"free dose combination tablets under fasted conditions first; then fixed-dose-combination (FDC) tablet under fasted conditions; then free dose combination tablets under fed conditions; then FDC tablet under fed conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
134940|NCT01811953|P2|Participant Flow|Emp/Met Fed / Emp+Met Fed / Emp/Met Fasted / Emp+Met Fasted|"fixed-dose-combination (FDC) tablet under fed conditions first; then free dose combination tablets under fed conditions; then FDC tablet under fasted conditions; then free dose combination tablets under fasted conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
135064|NCT01811472|B4|Baseline|Total|Total of all reporting groups
139817|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
134941|NCT01811953|P1|Participant Flow|Emp/Met Fasted / Emp+Met Fasted / Emp/Met Fed / Emp+Met Fed|"fixed-dose-combination (FDC) tablet under fasted conditions first; then free dose combination tablets under fasted conditions; then FDC tablet under fed conditions; then free dose combination tablets under fed conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
134942|NCT01811953|O6|Outcome|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: low dose of Empagliflozin oral administration~Metformin: oral administration"
134943|NCT01811953|O5|Outcome|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: low dose of Empagliflozin"
134944|NCT01811953|O4|Outcome|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
134945|NCT01811953|O3|Outcome|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
134946|NCT01811953|O2|Outcome|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
134947|NCT01811953|O1|Outcome|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
134948|NCT01811953|O6|Outcome|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: low dose of Empagliflozin oral administration~Metformin: oral administration"
134949|NCT01811953|O5|Outcome|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: low dose of Empagliflozin"
134950|NCT01811953|O4|Outcome|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
134951|NCT01811953|O3|Outcome|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
134952|NCT01811953|O2|Outcome|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
134953|NCT01811953|O1|Outcome|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
134954|NCT01811953|O6|Outcome|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: low dose of Empagliflozin oral administration~Metformin: oral administration"
134955|NCT01811953|O5|Outcome|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: low dose of Empagliflozin"
134956|NCT01811953|O4|Outcome|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
134957|NCT01811953|O3|Outcome|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
134958|NCT01811953|O2|Outcome|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
134959|NCT01811953|O1|Outcome|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
134960|NCT01811953|O6|Outcome|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: low dose of Empagliflozin oral administration~Metformin: oral administration"
134961|NCT01811953|O5|Outcome|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: low dose of Empagliflozin"
134962|NCT01811953|O4|Outcome|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
134963|NCT01811953|O3|Outcome|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
134964|NCT01811953|O2|Outcome|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
134965|NCT01811953|O1|Outcome|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
134966|NCT01811953|O6|Outcome|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: low dose of Empagliflozin oral administration~Metformin: oral administration"
134967|NCT01811953|O5|Outcome|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: low dose of Empagliflozin"
134968|NCT01811953|O4|Outcome|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
134969|NCT01811953|O3|Outcome|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
134970|NCT01811953|O2|Outcome|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
134971|NCT01811953|O1|Outcome|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
134972|NCT01811953|O6|Outcome|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: low dose of Empagliflozin oral administration~Metformin: oral administration"
134973|NCT01811953|O5|Outcome|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: low dose of Empagliflozin"
134974|NCT01811953|O4|Outcome|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
157779|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
134976|NCT01811953|O2|Outcome|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
134977|NCT01811953|O1|Outcome|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
134978|NCT01811953|E6|Reported Event|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: low dose of Empagliflozin oral administration~Metformin: oral administration"
134979|NCT01811953|E5|Reported Event|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: low dose of Empagliflozin"
134980|NCT01811953|E4|Reported Event|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
134981|NCT01811953|E3|Reported Event|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
134982|NCT01811953|E2|Reported Event|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
134983|NCT01811953|E1|Reported Event|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
134984|NCT01811732|B3|Baseline|Total|Total of all reporting groups
134985|NCT01811732|B2|Baseline|Vancomycin Plus Aztreonam + Placebo|"Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses~Vancomycin: Vancomycin~Aztreonam: Aztreonam~Placebo: Placebo"
134986|NCT01811732|B1|Baseline|Delafloxacin + Placebo|"300mg iv every 12 hours for a minimum of 10 and up to a maximum of 28 doses~Delafloxacin: Delafloxacin~Placebo: Placebo"
134987|NCT01811732|P2|Participant Flow|Vancomycin Plus Aztreonam + Placebo|"Vancomycin 15 mg/kg IV plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses~Vancomycin: Vancomycin~Aztreonam: Aztreonam~Placebo: Placebo"
134988|NCT01811732|P1|Participant Flow|Delafloxacin Plus Placebo|"300 mg IV every 12 hours, for a minimum of 10 and up to a maximum of 28 doses~Delafloxacin: Delafloxacin~Placebo: Placebo"
134989|NCT01811732|O2|Outcome|Vancomycin Plus Aztreonam + Placebo|"Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses~Vancomycin: Vancomycin~Aztreonam: Aztreonam~Placebo: Placebo"
134990|NCT01811732|O1|Outcome|Delafloxacin Plus Placebo|"300mg iv every 12 hours for a minimum of 10 and up to a maximum of 28 doses~Delafloxacin: Delafloxacin~Placebo: Placebo"
134991|NCT01811732|O2|Outcome|Vancomycin Plus Aztreonam + Placebo|"Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses~Vancomycin: Vancomycin~Aztreonam: Aztreonam~Placebo: Placebo"
134992|NCT01811732|O1|Outcome|Delafloxacin Plus Placebo|"300mg iv every 12 hours, for a minimum of 10 and up to a maximum of 28 doses~Delafloxacin: Delafloxacin~Placebo: Placebo"
134993|NCT01811732|O2|Outcome|Vancomycin Plus Aztreonam + Placebo|"Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses~Vancomycin: Vancomycin~Aztreonam: Aztreonam~Placebo: Placebo"
134994|NCT01811732|O1|Outcome|Delafloxacin Plus Placebo|"300mg iv every 12 hours for a minimum of 10 and up to a maximum of 28 doses~Delafloxacin: Delafloxacin~Placebo: Placebo"
134995|NCT01811732|E2|Reported Event|Vancomycin Plus Aztreonam + Placebo|"Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses~Vancomycin: Vancomycin~Aztreonam: Aztreonam~Placebo: Placebo"
134996|NCT01811732|E1|Reported Event|Delafloxacin Plus Placebo|"300mg iv every 12 hours, for a minimum of 10 and up to a maximum of 28 doses~Delafloxacin: Delafloxacin~Placebo: Placebo"
134997|NCT01811706|B1|Baseline|All Study Participants|
134998|NCT01811706|P2|Participant Flow|Placebo, Then Dalfampridine|"Participant first receive Placebo tablet orally every 12 hours, for a 4 weeks period. After a washout period of 2 weeks, they then receive Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks.~Dalfampridine: Dalfampridine will be provided at an oral dose of 10mg every 12 hours, for 4 weeks period~Placebo: Placebo will be administered orally every 12 hours, for a 4 week period."
134999|NCT01811706|P1|Participant Flow|Dalfampridine and Then Placebo|"Participant first receive Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks. After a washout period of 2 weeks, they then receive Placebo tablet orally every 12 hours, for a 4 weeks period.~Dalfampridine: Dalfampridine will be provided at an oral dose of 10mg every 12 hours, for 4 weeks period~Placebo: Placebo will be administered orally every 12 hours, for a 4 week period."
135000|NCT01811706|O2|Outcome|Placebo|Participant who received Placebo orally every 12 hours for a 4 week period.
135001|NCT01811706|O1|Outcome|Dalfampridine|Participant who received Dalfampridine at an oral dose of 10mg every 12 hours for 4 weeks period.
135002|NCT01811706|O2|Outcome|Placebo|Participant received Placebo orally every 12 hours for a 4 week period.
135003|NCT01811706|O1|Outcome|Dalfampridine|Participant received Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks period.
135004|NCT01811706|O2|Outcome|Placebo|Participant who received Placebo orally every 12 hours for a 4 week period.
135005|NCT01811706|O1|Outcome|Dalfampridine|Participant who received Dalfampridine at an oral dose of 10mg every 12 hours for 4 weeks period.
135006|NCT01811706|E2|Reported Event|Placebo|Participant received Placebo orally every 12 hours for a 4 week period.
135007|NCT01811706|E1|Reported Event|Dalfampridine|Participant received Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks period.
135008|NCT01811680|B1|Baseline|Supervised Treadmill Training|"Supervised treadmill training on variable sensing treadmill.~Variable Speed and Sensing Treadmill: open label study on variable speed and sending treadmill training for hemiplegic gait training."
135009|NCT01811680|P1|Participant Flow|Supervised Treadmill Training|"Supervised treadmill training on variable sensing treadmill.~Variable Speed and Sensing Treadmill: open label study on variable speed and sending treadmill training for hemiplegic gait training."
135010|NCT01811680|O1|Outcome|Supervised Treadmill Training|Supervised treadmill training on variable sensing treadmill.
135117|NCT01811355|O2|Outcome|Placebo First|"Placebo, capsule, PO BID, 14 days~Placebo: Placebo"
135011|NCT01811680|O1|Outcome|Supervised Treadmill Training|"Supervised treadmill training on variable sensing treadmill.~Variable Speed and Sensing Treadmill: open label study on variable speed and sending treadmill training for hemiplegic gait training."
135012|NCT01811680|E1|Reported Event|Supervised Treadmill Training|Research Intervention: Supervised treadmill training on variable sensing treadmill.
135013|NCT01811563|B3|Baseline|Total|Total of all reporting groups
135014|NCT01811563|B2|Baseline|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
135015|NCT01811563|B1|Baseline|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
135016|NCT01811563|P2|Participant Flow|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
135017|NCT01811563|P1|Participant Flow|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
135018|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
135019|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
135020|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
135021|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
135022|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
135023|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
135024|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
135025|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
135026|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
135027|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
135028|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
135029|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
135030|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
135031|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
135032|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
135033|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
135034|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
135035|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
135036|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
135037|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
135038|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
135039|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
135040|NCT01811563|E2|Reported Event|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
135041|NCT01811563|E1|Reported Event|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
135042|NCT01811485|B4|Baseline|Total|Total of all reporting groups
135043|NCT01811485|B3|Baseline|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
135044|NCT01811485|B2|Baseline|LMF237 50/500 mg|Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
135045|NCT01811485|B1|Baseline|LMF237 50/250 mg|Patients took LMF237 50/250 mg twice daily for 14 weeks
135046|NCT01811485|P3|Participant Flow|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
135047|NCT01811485|P2|Participant Flow|LMF237 50/500 mg|Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
135048|NCT01811485|P1|Participant Flow|LMF237 50/250 mg|Patients took LMF237 50/250 mg twice daily for 14 weeks
135049|NCT01811485|O3|Outcome|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
135050|NCT01811485|O2|Outcome|LMF237 50/500 mg|Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
135051|NCT01811485|O1|Outcome|LMF237 50/250 mg|Patients took LMF237 50/250 mg twice daily for 14 weeks
135052|NCT01811485|O2|Outcome|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
135053|NCT01811485|O1|Outcome|Pooled LMF237|All patients who took LMF237 50/250 mg or LMF237 50/500 mg twice daily for 14 weeks were pooled together as reporting group.
135054|NCT01811485|O2|Outcome|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
135055|NCT01811485|O1|Outcome|Pooled LMF237|All patients who took LMF237 50/250 mg or LMF237 50/500 mg twice daily for 14 weeks were pooled together as reporting group.
135056|NCT01811485|O2|Outcome|LMF237 50/500 mg|Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
135057|NCT01811485|O1|Outcome|LMF237 50/250 mg|Patients took LMF237 50/250 mg twice daily for 14 weeks
135058|NCT01811485|O2|Outcome|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
135059|NCT01811485|O1|Outcome|Pooled LMF237|All patients who took LMF237 50/250 mg or LMF237 50/500 mg twice daily for 14 weeks were pooled together as reporting group.
135060|NCT01811485|E4|Reported Event|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
135061|NCT01811485|E3|Reported Event|LMF237 50/500mg|Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
135062|NCT01811485|E2|Reported Event|LMF237 50/250mg|Patients took LMF237 50/250 mg twice daily for 14 weeks
135063|NCT01811485|E1|Reported Event|POOLED LMF237|All patients who has received LMF237
135065|NCT01811472|B3|Baseline|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135066|NCT01811472|B2|Baseline|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135067|NCT01811472|B1|Baseline|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135068|NCT01811472|P3|Participant Flow|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135069|NCT01811472|P2|Participant Flow|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135070|NCT01811472|P1|Participant Flow|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135071|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135072|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135073|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135074|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135075|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135076|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135077|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135078|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135079|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135080|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135118|NCT01811355|O1|Outcome|Mexiletine First|"Mexiletine, capsule, 150mg, PO BID, 14 days~Mexiletine: Sodium channel blocker"
135119|NCT01811355|O2|Outcome|Placebo First/Mexiletine Second|"Placebo, capsule, PO BID, 14 days~Mexiletine, capsule, 150mg, PO BID, 14 days"
157780|NCT01717989|O4|Outcome|Q3 2011|Third quarter, 2011
135081|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135082|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135083|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135084|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135085|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135086|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135087|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135088|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135089|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135090|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135091|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135092|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135093|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135094|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135095|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135096|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135097|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135098|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135099|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135100|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135101|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135102|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135103|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135104|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135105|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135106|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135107|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135108|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135109|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135110|NCT01811472|E4|Reported Event|Pooled Pradigastat (LCQ908)|This arm included all patients randomized to pradigastat (LCQ908) 5mg/10 mg and pradigastat (LCQ908)10mg/20 mg
135111|NCT01811472|E3|Reported Event|Pradigastat (LCQ908) 10mg/20 mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135112|NCT01811472|E2|Reported Event|Pradigastat (LCQ908) 5mg /10 mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135113|NCT01811472|E1|Reported Event|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
135114|NCT01811355|B1|Baseline|Total Subjects Enrolled|A total of 23 subjects were enrolled. 11 were randomized to receive study drug first, followed by placebo. 12 subjects received placebo first and study drug second. Overall participant characteristics are displayed in the baseline table.
135115|NCT01811355|P2|Participant Flow|Placebo First/Mexiletine Second|"Placebo, capsule, PO BID, 14 days~Mexiletine, capsule, 150mg, PO BID, 14 days"
135116|NCT01811355|P1|Participant Flow|Mexiletine First/Placebo Second|"Mexiletine, capsule, 150mg, PO BID, 14 days~Placebo, capsule, PO BID, 14 days"
135120|NCT01811355|O1|Outcome|Mexiletine First/Placebo Second|"Mexiletine, capsule, 150mg, PO BID, 14 days~Placebo, capsule, PO BID, 14 days"
135121|NCT01811355|E2|Reported Event|Placebo|"Placebo, capsule, PO BID, 14 days~Placebo: Placebo"
135122|NCT01811355|E1|Reported Event|Mexiletine|"Mexiletine, capsule, 150mg, PO BID, 14 days~Mexiletine: Sodium channel blocker"
135123|NCT01811316|B4|Baseline|Total|Total of all reporting groups
135124|NCT01811316|B3|Baseline|Placebo Lozenge (Once a Day)|Subjects take their lozenge once a day, one lozenge at night after brushing.
135125|NCT01811316|B2|Baseline|Probiotics Lozenge (Once a Day)|Subjects take their lozenge once a day, one lozenge at night after brushing.
135126|NCT01811316|B1|Baseline|Probiotics Lozenge (Twice a Day)|Subjects take their lozenge twice a day, one lozenge in the morning after brushing and one lozenge in the evening after brushing.
135127|NCT01811316|P3|Participant Flow|Placebo Lozenge (Once a Day)|Subjects take their lozenge once a day, one lozenge at night after brushing.
135128|NCT01811316|P2|Participant Flow|Probiotics Lozenge (Once a Day)|Subjects take their lozenge once a day, one lozenge at night after brushing.
135129|NCT01811316|P1|Participant Flow|Probiotics Lozenge (Twice a Day)|Subjects take their lozenge twice a day, one lozenge in the morning after brushing and one lozenge in the evening after brushing.
135130|NCT01811316|O3|Outcome|Placebo Lozenge (Once a Day)|Subjects take their lozenge once a day, one lozenge at night after brushing.
135131|NCT01811316|O2|Outcome|Probiotics Lozenge (Once a Day)|Subjects take their lozenge once a day, one lozenge at night after brushing.
135132|NCT01811316|O1|Outcome|Probiotics Lozenge (Twice a Day)|Subjects take their lozenge twice a day, one lozenge in the morning after brushing and one lozenge in the evening after brushing.
135133|NCT01811316|O3|Outcome|Placebo Lozenge (Once a Day)|Subjects take their lozenge once a day, one lozenge at night after brushing.
135134|NCT01811316|O2|Outcome|Probiotics Lozenge (Once a Day)|Subjects take their lozenge once a day, one lozenge at night after brushing.
135135|NCT01811316|O1|Outcome|Probiotics Lozenge (Twice a Day)|Subjects take their lozenge twice a day, one lozenge in the morning after brushing and one lozenge in the evening after brushing.
135136|NCT01811316|O3|Outcome|Placebo Lozenge (Once a Day)|Subjects take their lozenge once a day, one lozenge at night after brushing.
135137|NCT01811316|O2|Outcome|Probiotics Lozenge (Once a Day)|Subjects take their lozenge once a day, one lozenge at night after brushing.
135138|NCT01811316|O1|Outcome|Probiotics Lozenge (Twice a Day)|Subjects take their lozenge twice a day, one lozenge in the morning after brushing and one lozenge in the evening after brushing.
135139|NCT01811316|O3|Outcome|Placebo Lozenge (Once a Day)|Subjects take their lozenge once a day, one lozenge at night after brushing.
135140|NCT01811316|O2|Outcome|Probiotics Lozenge (Once a Day)|Subjects take their lozenge once a day, one lozenge at night after brushing.
135141|NCT01811316|O1|Outcome|Probiotics Lozenge (Twice a Day)|Subjects take their lozenge twice a day, one lozenge in the morning after brushing and one lozenge in the evening after brushing.
135142|NCT01811316|E3|Reported Event|Placebo Lozenge (Once a Day)|Subjects take their lozenge once a day, one lozenge at night after brushing.
135143|NCT01811316|E2|Reported Event|Probiotics Lozenge (Once a Day)|Subjects take their lozenge once a day, one lozenge at night after brushing.
135144|NCT01811316|E1|Reported Event|Probiotics Lozenge (Twice a Day)|Subjects take their lozenge twice a day, one lozenge in the morning after brushing and one lozenge in the evening after brushing.
135145|NCT01811303|B1|Baseline|D-fagomine (All Study Participants)|Measure the changes produced on the postprandial Glycaemic response to 50 g of sucrose containing 40 mg D-fagomine, in 200 ml water vs placebo.
135146|NCT01811303|P4|Participant Flow|Treatment, Placebo, Treatment, Placebo|The subjects receive placebo or treatment in each intervention alternatively, starting with treatment.
135147|NCT01811303|P3|Participant Flow|Placebo, Treatment, Placebo, Treatment|The subjects receive placebo or treatment in each intervention alternatively, starting with placebo.
135148|NCT01811303|P2|Participant Flow|Treatment, Treatment, Placebo, Placebo|The subjects receive treatment in the first two interventions
135149|NCT01811303|P1|Participant Flow|Placebo, Placebo, Treatment, Treatment|The subjects receive placebo in the first two interventions.
135150|NCT01811303|O2|Outcome|Control|Determination of glucose Cmax over the Baseline of the control: sucrose 50 g + 200 ml water. Blood glucose concentration expressed in mmol/l.
135151|NCT01811303|O1|Outcome|D-fagomine|Determination of glucose Cmax over the Baseline of the treatment: sucrose 50 g + 200 ml water + 40 mg D-fagomine. Blood glucose concentration expressed in mmol/l.
135152|NCT01811303|O2|Outcome|Change D-fagomine/Control AUC at 120 Min|Determine the relative change in the Glycaemic response between sucrose with D-fagomine and sucrose without D-fagomine in the first 120 minutes (postprandial). Calculated on incremental Area Under the Curve (AUC) from the individual glucose measurements in capillary blood, and evaluated by repeated measures ANOVA.
135153|NCT01811303|O1|Outcome|Change D-fagomine/Control AUC at 60 Min|Determine the relative change in the Glycaemic response between sucrose with D-fagomine and sucrose without D-fagomine in the first 60 minutes (postprandial). Calculated on incremental Area Under the Curve (AUC) from the individual glucose measurements in capillary blood, and evaluated by repeated measures ANOVA.
135154|NCT01811303|E2|Reported Event|Placebo - Control (All Study Participants)|Measure the changes produced on the postprandial Glycaemic response to 50 g sucrose in 200 ml water (without d-fagomine)
135155|NCT01811303|E1|Reported Event|D-fagomine (All Study Participants)|Measure the changes produced on the postprandial Glycaemic response to 50 g of sucrose containing 40 mg D-fagomine, in 200 ml water.
135156|NCT01811238|B1|Baseline|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
135157|NCT01811238|P1|Participant Flow|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
135158|NCT01811238|O1|Outcome|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
135159|NCT01811238|O1|Outcome|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
135160|NCT01811238|O1|Outcome|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
135298|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
135161|NCT01811238|O1|Outcome|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
135162|NCT01811238|O1|Outcome|Oxycodone/Naloxone|"Single-arm study~Oxycodone/naloxone: Targin 5mg, 10mg, 20mg up to 40mg b.i.d"
135163|NCT01811238|O1|Outcome|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
135164|NCT01811238|E1|Reported Event|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
135165|NCT01811212|B1|Baseline|Treatment (Cabozantinib-s-malate)|Patients receive Cabozantinib 60mg PO QD with dose escalation to 80mg QD or dose reduction to 40mg daily or 20mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
135166|NCT01811212|P1|Participant Flow|Treatment (Cabozantinib-s-malate)|Patients receive Cabozantinib 60mg PO QD with dose escalation to 80mg QD or dose reduction to 40mg daily or 20mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
135167|NCT01811212|O1|Outcome|Treatment (Cabozantinib-s-malate)|Patients receive Cabozantinib 60mg PO QD with dose escalation to 80mg QD or dose reduction to 40mg daily or 20mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
135168|NCT01811212|O1|Outcome|Treatment (Cabozantinib-s-malate)|Patients receive Cabozantinib 60mg PO QD with dose escalation to 80mg QD or dose reduction to 40mg daily or 20mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
135169|NCT01811212|O1|Outcome|Treatment (Cabozantinib-s-malate)|Patients receive Cabozantinib 60mg PO QD with dose escalation to 80mg QD or dose reduction to 40mg daily or 20mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
135170|NCT01811212|O1|Outcome|Treatment (Cabozantinib-s-malate)|Patients receive Cabozantinib 60mg PO QD with dose escalation to 80mg QD or dose reduction to 40mg daily or 20mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
135171|NCT01811212|O1|Outcome|Treatment (Cabozantinib-s-malate)|Patients receive Cabozantinib 60mg PO QD with dose escalation to 80mg QD or dose reduction to 40mg daily or 20mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
135172|NCT01811212|O1|Outcome|Treatment (Cabozantinib-s-malate)|Patients receive Cabozantinib 60mg PO QD with dose escalation to 80mg QD or dose reduction to 40mg daily or 20mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
135173|NCT01811212|O1|Outcome|Treatment (Cabozantinib-s-malate)|Patients receive Cabozantinib 60mg PO QD with dose escalation to 80mg QD or dose reduction to 40mg daily or 20mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
135174|NCT01811212|O1|Outcome|Treatment (Cabozantinib-s-malate)|Patients receive Cabozantinib 60mg PO QD with dose escalation to 80mg QD or dose reduction to 40mg daily or 20mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
135175|NCT01811212|O1|Outcome|Treatment (Cabozantinib-s-malate)|Patients receive Cabozantinib 60mg PO QD with dose escalation to 80mg QD or dose reduction to 40mg daily or 20mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
135176|NCT01811212|O1|Outcome|Treatment (Cabozantinib-s-malate)|Patients receive Cabozantinib 60mg PO QD with dose escalation to 80mg QD or dose reduction to 40mg daily or 20mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
135177|NCT01811212|E1|Reported Event|Treatment (Cabozantinib-s-malate)|"Patients receive cabozantinib-s-malate PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cabozantinib S-malate: Given PO~Laboratory Biomarker Analysis: Correlative studies"
135178|NCT01811186|B3|Baseline|Total|Total of all reporting groups
135179|NCT01811186|B2|Baseline|Start Oxycodone/Naloxone 5/2.5mg b.i.d|Start oxycodone/naloxone 5/2.5mg b.i.d titration-> 10/5mg b.i.d.->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
135180|NCT01811186|B1|Baseline|Start Oxycodone/Naloxone 10/5mg b.i.d|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
135181|NCT01811186|P2|Participant Flow|Start Oxycodone/Naloxone 5/2.5mg b.i.d|Start oxycodone/naloxone 5/2.5mg b.i.d->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
135182|NCT01811186|P1|Participant Flow|Start Oxycodone/Naloxone 10/5mg b.i.d.|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
135183|NCT01811186|O2|Outcome|Start Oxycodone/Naloxone 5/2.5mg b.i.d.|Start oxycodone/naloxone 5/2.5mg b.i.d titration-> 10/5mg b.i.d.->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
135184|NCT01811186|O1|Outcome|Start Oxycodone/Naloxone 10/5mg b.i.d.|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
135185|NCT01811186|O2|Outcome|Start Oxycodone/Naloxone 5/2.5mg b.i.d|Start oxycodone/naloxone 5/2.5mg b.i.d->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
135186|NCT01811186|O1|Outcome|Start Oxycodone/Naloxone 10/5mg b.i.d|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d
135187|NCT01811186|O2|Outcome|Start Oxycodone/Naloxone 5/2.5mg b.i.d.|Start oxycodone/naloxone 5/2.5mg b.i.d->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
135188|NCT01811186|O1|Outcome|Start Oxycodone/Naloxone 10/5mg b.i.d.|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d
135189|NCT01811186|O2|Outcome|Start Oxycodone/Naloxone 5/2.5mg b.i.d.|Start oxycodone/naloxone 5/2.5mg b.i.d->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
135190|NCT01811186|O1|Outcome|Start Oxycodone/Naloxone 10/5mg b.i.d.|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d
135191|NCT01811186|O2|Outcome|Start Oxycodone/Naloxone 5/2.5mg b.i.d.|Start oxycodone/naloxone 5/2.5mg b.i.d->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
135192|NCT01811186|O1|Outcome|Start Oxycodone/Naloxone 10/5mg b.i.d.|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d
135193|NCT01811186|O2|Outcome|Start Oxycodone/Naloxone 5/2.5mg b.i.d.|Start oxycodone/naloxone 5/2.5mg b.i.d->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
135194|NCT01811186|O1|Outcome|Start Oxycodone/Naloxone 10/5mg b.i.d.|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d
157781|NCT01717989|O3|Outcome|Q2 2011|Second quarter, 2011
135195|NCT01811186|E2|Reported Event|Start Oxycodone/Naloxone 5/2.5mg b.i.d|Start oxycodone/naloxone 5/2.5mg b.i.d titration-> 10/5mg b.i.d.->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
135196|NCT01811186|E1|Reported Event|Start Oxycodone/Naloxone 10/5mg b.i.d|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
135197|NCT01810952|B3|Baseline|Total|Total of all reporting groups
135198|NCT01810952|B2|Baseline|Glargine/Lispro/NPH Insulin Arm|"The basal and prandial doses of glargine and lispro insulin were similar to those in the Glargine/Lispro Arm. A coverage dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. The maximum starting coverage dose was 0.4 units/kg per day."
135199|NCT01810952|B1|Baseline|Glargine/Lispro Insulin Arm|"The Glargine/Lispro Arm included 0.2 unit/kg/day as insulin glargine daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A coverage dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting coverage dose was 0.4 units/kg per day.~Glargine/Lispro insulin: In both protocols glargine dose was increased by 10% if the fasting glucose value was 141-200 mg/dL and by 20% if the fasting glucose value was more than 200 mg/dL, and decreased by 10% if the fasting FSG was 70-89 mg/dL and by 20% if the fasting FSG was less than 70 mg/dL."
135200|NCT01810952|P2|Participant Flow|Glargine/Lispro/NPH Insulin|"The basal and prandial doses of glargine and lispro insulin were similar to those in the Glargine/Lispro Arm. A coverage dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. The maximum starting coverage dose was 0.4 units/kg per day."
135201|NCT01810952|P1|Participant Flow|Glargine/Lispro Insulin|"The Glargine/Lispro Arm included 0.2 unit/kg/day as insulin glargine daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A coverage dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting coverage dose was 0.4 units/kg per day.~Glargine/Lispro insulin: In both protocols glargine dose was increased by 10% if the fasting glucose value was 141-200 mg/dL and by 20% if the fasting glucose value was more than 200 mg/dL, and decreased by 10% if the fasting FSG was 70-89 mg/dL and by 20% if the fasting FSG was less than 70 mg/dL."
135202|NCT01810952|O2|Outcome|Glargine/Lispro/NPH Insulin Arm|
135203|NCT01810952|O1|Outcome|Glargine/Lispro Insulin Arm|
135204|NCT01810952|O2|Outcome|Glargine/Lispro/NPH Insulin Arm|
135205|NCT01810952|O1|Outcome|Glargine/Lispro Insulin Arm|
135206|NCT01810952|O2|Outcome|Glargine/Lispro/NPH Insulin Arm|Insulin (units)/kg body weight
135207|NCT01810952|O1|Outcome|Glargine/Lispro Insulin Arm|Insulin (units)/kg body weight
135208|NCT01810952|O2|Outcome|Glargine/Lispro/NPH Insulin Arm|Last Full Day of Protocol
135209|NCT01810952|O1|Outcome|Glargine/Lispro Insulin Arm|Last Full Day of Protocol
135210|NCT01810952|O2|Outcome|Glargine/Lispro/NPH Insulin Arm|"Basal and meal coverage for G/L/N Arm is similar to that in the GL Arm. A coverage dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent will be given twice daily with the administration of the glucocorticoid. The maximum starting coverage dose will be 0.4 units/kg per day.~Glargine/Lispro/NPH insulin: The G/L/N Protocol will include 0.2 unit/kg/day as insulin glargine daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all the insulin-naïve patients. A coverage dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent will be given twice daily with the administration of the glucocorticoid. The maximum starting coverage dose will be 0.4 units/kg per day."
135211|NCT01810952|O1|Outcome|Glargine/Lispro Insulin Arm|"The G/L Arm will include 0.2 unit/kg/day as insulin glargine daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A coverage dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent will be divided between 3 meals. The maximum starting coverage dose will be 0.4 units/kg per day.~Glargine/Lispro insulin: In both protocols glargine dose will be increased by 10% if the fasting glucose value is 141-200 mg/dL and by 20% if the fasting glucose value is more than 200 mg/dL, and decreased by 10% if the fasting FSG is 70-89 mg/dL and by 20% if the fasting FSG is less than 70 mg/dL."
135212|NCT01810952|E2|Reported Event|Glargine/Lispro/NPH Insulin Arm|"The basal and prandial doses of glargine and lispro were similar to those in the G/L/N Protocol. A coverage dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. The maximum starting coverage dose was 0.4 units/kg per day."
135213|NCT01810952|E1|Reported Event|Glargine/Lispro Insulin Arm|"The G/L Arm received 0.2 unit/kg/day as insulin glargine daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A coverage dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting coverage dose was 0.4 units/kg per day.~Glargine/Lispro insulin: In both protocols glargine dose was increased by 10% if the fasting glucose value was 141-200 mg/dL and by 20% if the fasting glucose value was more than 200 mg/dL, and decreased by 10% if the fasting FSG was 70-89 mg/dL and by 20% if the fasting FSG was less than 70 mg/dL."
135214|NCT01810939|B1|Baseline|Part A Patiromer|Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks.
135215|NCT01810939|P3|Participant Flow|Part B Placebo|Participants were administered placebo orally twice a day for 8 weeks.
135216|NCT01810939|P2|Participant Flow|Part B Patiromer|Participants continued on the same daily patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks.
135217|NCT01810939|P1|Participant Flow|Part A Patiromer|Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks.
135218|NCT01810939|O2|Outcome|Part B Patiromer|Participants continued on the same daily patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks.
135219|NCT01810939|O1|Outcome|Part B Placebo|Participants were administered placebo orally twice a day for 8 weeks.
157782|NCT01717989|O2|Outcome|Q1 2011|First quarter 2011
135220|NCT01810939|O1|Outcome|Part A Patiromer|Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks. The dose of patiromer could be titrated based on participant's serum potassium response.
135221|NCT01810939|O2|Outcome|Part B Patiromer|Participants continued on the same daily patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks.
135222|NCT01810939|O1|Outcome|Part B Placebo|Participants were administered placebo orally twice a day for 8 weeks.
135223|NCT01810939|O2|Outcome|Part B Patiromer|Participants continued on the same daily patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks.
135224|NCT01810939|O1|Outcome|Part B Placebo|Participants were administered placebo orally twice a day for 8 weeks.
135225|NCT01810939|O1|Outcome|Part A Patiromer|Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks.
135226|NCT01810939|E3|Reported Event|Part B Placebo|Participants were administered placebo orally twice a day for 8 weeks.
135227|NCT01810939|E2|Reported Event|Part B Patiromer|Participants continued on the same daily patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks.
135228|NCT01810939|E1|Reported Event|Part A Patiromer|Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks.
135229|NCT01810783|B1|Baseline|Brexpiprazole|Brexpiprazole: 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).
135230|NCT01810783|P1|Participant Flow|Brexpiprazole|Brexpiprazole: 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).
135231|NCT01810783|O1|Outcome|Brexpiprazole|Brexpiprazole: 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).
135232|NCT01810783|E1|Reported Event|Brexpiprazole|210 were enrolled, only 209 patients were treated with brexpiprazole
135233|NCT01810692|B3|Baseline|Total|Total of all reporting groups
135234|NCT01810692|B2|Baseline|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
135235|NCT01810692|B1|Baseline|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
135236|NCT01810692|P2|Participant Flow|Hirobriz/Onbrez/Oslif Breezhaler|Patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
135237|NCT01810692|P1|Participant Flow|Spiriva Respimat|Patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
135238|NCT01810692|O2|Outcome|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
135239|NCT01810692|O1|Outcome|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
135240|NCT01810692|O2|Outcome|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
135241|NCT01810692|O1|Outcome|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
135242|NCT01810692|O2|Outcome|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
135243|NCT01810692|O1|Outcome|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
135244|NCT01810692|O2|Outcome|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
135245|NCT01810692|O1|Outcome|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
135246|NCT01810692|E2|Reported Event|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
135247|NCT01810692|E1|Reported Event|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
135248|NCT01810666|B1|Baseline|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
135249|NCT01810666|P1|Participant Flow|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
135299|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
135300|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
135250|NCT01810666|O1|Outcome|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
135251|NCT01810666|O1|Outcome|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
135252|NCT01810666|O1|Outcome|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
135253|NCT01810666|E1|Reported Event|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
135254|NCT01810380|B4|Baseline|Total|Total of all reporting groups
135255|NCT01810380|B3|Baseline|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
135256|NCT01810380|B2|Baseline|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
135257|NCT01810380|B1|Baseline|Placebo|Placebo: Once daily as tablets and capsules, orally
135258|NCT01810380|P3|Participant Flow|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
135259|NCT01810380|P2|Participant Flow|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
135260|NCT01810380|P1|Participant Flow|Placebo|Placebo: Once daily as tablets and capsules, orally
135261|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
135262|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
135263|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
135264|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
135265|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
135266|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
135267|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
135268|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
135269|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
135270|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
135271|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
135272|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
135273|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
135274|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
135275|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
135276|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
135277|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
135278|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
135279|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
135280|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
135281|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
135282|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
135283|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
135284|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
135285|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
135286|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
135287|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
135288|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
135289|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
135290|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
135291|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
135292|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
135293|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
135294|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
135295|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
135296|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
135297|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
135303|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
135304|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
135305|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
135306|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
135307|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
135308|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
135309|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
135310|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
135311|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
135312|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
135313|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
135314|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
135315|NCT01810380|E3|Reported Event|Quetiapine|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
135316|NCT01810380|E2|Reported Event|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
135317|NCT01810380|E1|Reported Event|Placebo|Placebo: Once daily as tablets and capsules, orally
135318|NCT01810302|B3|Baseline|Total|Total of all reporting groups
135319|NCT01810302|B2|Baseline|Preservative-free Normal Saline|"Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.~Preservative-free normal saline: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10."
135320|NCT01810302|B1|Baseline|Nicardipine Hydrochloride|"Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.~Nicardipine hydrochloride: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10."
135321|NCT01810302|P2|Participant Flow|Preservative-free Normal Saline|"Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.~Preservative-free normal saline: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10."
135322|NCT01810302|P1|Participant Flow|Nicardipine Hydrochloride|"Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.~Nicardipine hydrochloride: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10."
135323|NCT01810302|O2|Outcome|Preservative-free Normal Saline|"Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.~Preservative-free normal saline: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10."
135324|NCT01810302|O1|Outcome|Nicardipine Hydrochloride|"Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.~Nicardipine hydrochloride: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10."
135325|NCT01810302|O2|Outcome|Preservative-free Normal Saline|"Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.~Preservative-free normal saline: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10."
135326|NCT01810302|O1|Outcome|Nicardipine Hydrochloride|"Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.~Nicardipine hydrochloride: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10."
135327|NCT01810302|E2|Reported Event|Preservative-free Normal Saline|"Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.~Preservative-free normal saline: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10."
135328|NCT01810302|E1|Reported Event|Nicardipine Hydrochloride|"Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.~Nicardipine hydrochloride: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10."
135329|NCT01810289|B3|Baseline|Total|Total of all reporting groups
135330|NCT01810289|B2|Baseline|Post-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
135331|NCT01810289|B1|Baseline|Pre-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
135332|NCT01810289|P2|Participant Flow|Post-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
135333|NCT01810289|P1|Participant Flow|Pre-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
135334|NCT01810289|O2|Outcome|Post-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
135335|NCT01810289|O1|Outcome|Pre-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
135336|NCT01810289|E2|Reported Event|Post-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
135379|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
135337|NCT01810289|E1|Reported Event|Pre-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
135338|NCT01810263|B3|Baseline|Total|Total of all reporting groups
135339|NCT01810263|B2|Baseline|Control|no intervention
135340|NCT01810263|B1|Baseline|High Protein Supplement|high protein supplement given
135341|NCT01810263|P2|Participant Flow|Control|Patients in the both groups keep on routine diet in the hospital. No additional calories are provided.
135342|NCT01810263|P1|Participant Flow|High Protein Supplement|"Patients in the both groups keep on routine diet in the hospital All the patients in the High Protein Supplement group were provided additional calories of Nucare(High protein fluid diet, 200kcal/200ml/1 can. Dasang, Seoul, Korea) three times a day.~(As a result, additional calories are 600kcal a day)"
135343|NCT01810263|O2|Outcome|Control|no intervention
135344|NCT01810263|O1|Outcome|High Protein Supplement|high protein supplement given
135345|NCT01810263|E2|Reported Event|Control|no intervention
135346|NCT01810263|E1|Reported Event|High Protein Supplement|high protein supplement given
135347|NCT01810042|B1|Baseline|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.~intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
135348|NCT01810042|P1|Participant Flow|Ranibizumab|"Ranibizumab is injected monthly 3 times then pro re nata (PRN) to 6 months.~intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
135349|NCT01810042|O1|Outcome|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.~intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
135350|NCT01810042|O1|Outcome|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.~intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
135351|NCT01810042|O1|Outcome|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.~intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
135352|NCT01810042|O1|Outcome|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.~intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
135353|NCT01810042|E1|Reported Event|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.~intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
135354|NCT01809938|B1|Baseline|Entire Study Population|Includes all participants in this crossover trial
135355|NCT01809938|P2|Participant Flow|Tea With Milk First Then Black Tea|Effects on gastric emptying of Tea with Milk (250mls of tea with 50mls of full fat millk) were assessed then after a period of not less than 24 hours the effects of Black tea (300ml of tea without milk) were assessed.
135356|NCT01809938|P1|Participant Flow|Black Tea First, Then Tea With Milk|Effects on gastric emptying of Black tea (300ml of tea without milk) were assessed then after a period of not less than 24 hours the effects of Tea with Milk (250mls of tea with 50mls of full fat millk) were assessed
135357|NCT01809938|O2|Outcome|Tea With Milk|Tea with milk : 250ml of black tea with 50ml of full fat milk
135358|NCT01809938|O1|Outcome|Black Tea|Black tea : 300ml of tea without milk
135359|NCT01809938|O2|Outcome|Tea With Milk|Tea with milk : 250ml of black tea with 50ml of full fat milk
135360|NCT01809938|O1|Outcome|Black Tea|Black tea : 300ml of tea without milk
135361|NCT01809938|E1|Reported Event|Entire Study Population|Includes all participants in this crossover trial
135362|NCT01809899|B3|Baseline|Total|Total of all reporting groups
135363|NCT01809899|B2|Baseline|Consent as Usual Procedure|Participants in this group will receive a normal consent procedure to the study
135364|NCT01809899|B1|Baseline|Enhanced Consent Procedure|"Participants in this group will receive an enhanced consent that will be an hour longer than usual.~Consent procedure: Enhanced consent entails a more detailed consent procedure than is routine."
135365|NCT01809899|P2|Participant Flow|Consent as Usual|Consent as Usual, with no Enhanced Consent features
135366|NCT01809899|P1|Participant Flow|Enhanced Consent Procedure|Enhanced consent includes use of teach back methods, video clips illustrating various study methods, and repeated confirmation of consent.
135367|NCT01809899|O2|Outcome|Consent as Usual|Consent as Usual, involving no Enhanced Consent features
135368|NCT01809899|O1|Outcome|Enhanced Consent Procedure|Enhanced Consent Procedure involved enhanced IRB consent procedures.
135369|NCT01809899|O2|Outcome|Consent as Usual|Consent as Usual, involving no Enhanced Consent features
135370|NCT01809899|O1|Outcome|Enhanced Consent Procedure|Enhanced Consent Procedure involved enhanced Institutional Review Board (IRB) consent procedures.
135371|NCT01809899|E2|Reported Event|Consent as Usual Procedure|"Participants in this group will receive a normal consent procedure to the study~Consent procedure: Enhanced consent entails a more detailed consent procedure"
135372|NCT01809899|E1|Reported Event|Enhanced Consent Procedure|"Participants in this group will receive an enhanced consent that will be an hour longer than usual.~Consent procedure: Enhanced consent entails a more detailed consent procedure"
135373|NCT01809834|B1|Baseline|All Participants|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
135374|NCT01809834|P1|Participant Flow|All Participants|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simulataneously~Etafilcon A~Stenfilcon A"
135375|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
135376|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
135377|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
135378|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
135380|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
135381|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
135382|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
135383|NCT01809834|O1|Outcome|All Participants|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
135384|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
135385|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
135386|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
135387|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
135388|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
135389|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
135390|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
135391|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
135392|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
135393|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
135394|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
135395|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
135396|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
135397|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
135398|NCT01809834|E1|Reported Event|All Participants|"Each participant was randomized to wear the test lens in one eye and the control lens in the other~Etafilcon A~Stenfilcon A"
135399|NCT01809639|B3|Baseline|Total|Total of all reporting groups
135400|NCT01809639|B2|Baseline|Placebo|Placebo: Standard placebo for 5 days
135401|NCT01809639|B1|Baseline|Progesterone|"400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five~Progesterone"
135402|NCT01809639|P2|Participant Flow|Placebo|Placebo: Standard placebo for 5 days
135403|NCT01809639|P1|Participant Flow|Progesterone|"400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five~Progesterone"
135404|NCT01809639|O2|Outcome|Placebo|Placebo: Standard placebo for 5 days
135405|NCT01809639|O1|Outcome|Progesterone|"400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five~Progesterone"
135406|NCT01809639|E2|Reported Event|Placebo|Placebo: Standard placebo for 5 days
135407|NCT01809639|E1|Reported Event|Progesterone|"400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five~Progesterone"
135408|NCT01809327|B6|Baseline|Total|Total of all reporting groups
135409|NCT01809327|B5|Baseline|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
135410|NCT01809327|B4|Baseline|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
135411|NCT01809327|B3|Baseline|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
135412|NCT01809327|B2|Baseline|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
135413|NCT01809327|B1|Baseline|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
135414|NCT01809327|P5|Participant Flow|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
135415|NCT01809327|P4|Participant Flow|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
135487|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
157783|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter, 2010
135416|NCT01809327|P3|Participant Flow|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
135417|NCT01809327|P2|Participant Flow|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
135418|NCT01809327|P1|Participant Flow|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
135419|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
135420|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
135421|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
135422|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
135423|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
135424|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
135425|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
135426|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
135427|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
135428|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
135429|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
135430|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
135431|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
135432|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
135433|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
135434|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
135435|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
135436|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
135437|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
135488|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
135489|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
135438|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
135439|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
135440|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
135441|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
135442|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
135443|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
135444|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
135445|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
135446|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
135447|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
135448|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
135449|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
135450|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
135451|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
135452|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
135453|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
135454|NCT01809327|E5|Reported Event|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
135455|NCT01809327|E4|Reported Event|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
135456|NCT01809327|E3|Reported Event|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
135457|NCT01809327|E2|Reported Event|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
135458|NCT01809327|E1|Reported Event|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
135459|NCT01809314|B1|Baseline|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
135490|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
135460|NCT01809314|P1|Participant Flow|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
135461|NCT01809314|O1|Outcome|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
135462|NCT01809314|O1|Outcome|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
135463|NCT01809314|O1|Outcome|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
135464|NCT01809314|E1|Reported Event|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
135465|NCT01809262|B1|Baseline|Study Total|Total number of patients treated in the study. This was a double-blind, 5-period crossover trial. Each of the 36 patients received placebo and 4 single doses of Olodaterol (Olo) (2 microgram (mcg), 5 mcg, 10 mcg, 20mcg) separated by a wash-out period of at least 14 days.
135466|NCT01809262|P10|Participant Flow|Olo 20mcg / Olo 10mcg / Placebo / Olo 5mcg / Olo 2mcg|Patients were administered Olodaterol 20 mcg qd in the first period, Olodaterol 10 mcg qd in the second period, matching Placebo in the third period, Olodaterol 5 mcg qd in the fourth period and Olodaterol 2 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
135467|NCT01809262|P9|Participant Flow|Olo 20mcg / Placebo / Olo 10mcg / Olo 2mcg / Olo 5mcg|Patients were administered Olodaterol 20 mcg qd in the first period, matching Placebo in the second period, Olodaterol 10 mcg qd in the third period, Olodaterol 2 mcg qd in the fourth period and Olodaterol 5 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
135468|NCT01809262|P8|Participant Flow|Olo 10mcg / Olo 5mcg / Olo 20mcg / Olo 2mcg / Placebo|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 20 mcg qd in the third period, Olodaterol 2 mcg qd in the fourth period and matching Placebo in the fifth period. Olodaterol was administered via the Respimat inhaler.
135469|NCT01809262|P7|Participant Flow|Olo 10mcg / Olo 20mcg / Olo 5mcg / Placebo / Olo 2mcg|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 20 mcg qd in the second period, Olodaterol 5 mcg qd in the third period, matching Placebo in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
135470|NCT01809262|P6|Participant Flow|Olo 5mcg / Olo 10mcg / Olo 2mcg / Olo 20mcg / Placebo|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 2 mcg qd in the third period, Olodaterol 20 mcg qd in the fourth period and matching Placebo in the fifth period. Olodaterol was administered via the Respimat inhaler.
135471|NCT01809262|P5|Participant Flow|Olo 5mcg / Olo 2mcg / Olo 10mcg / Placebo / Olo 20mcg|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 2 mcg qd in the second period, Olodaterol 10 mcg qd in the third period, matching Placebo in the fourth period and Olodaterol 20 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
135472|NCT01809262|P4|Participant Flow|Olo 2mcg / Placebo / Olo 5mcg / Olo 20mcg / Olo 10mcg|Patients were administered Olodaterol 2 mcg qd in the first period, matching Placebo in the second period, Olodaterol 5 mcg qd in the third period, Olodaterol 20 mcg qd in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
135473|NCT01809262|P3|Participant Flow|Olo 2mcg / Olo 5mcg / Placebo / Olo 10mcg / Olo 20mcg|Patients were administered Olodaterol 2 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, matching Placebo in the third period, Olodaterol 10 mcg qd in the fourth period and Olodaterol 20 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
135474|NCT01809262|P2|Participant Flow|Placebo / Olo 20mcg / Olo 2mcg / Olo 10mcg / Olo 5mcg|Patients were administered matching Placebo in the first period, Olodaterol 20 mcg qd in the second period, Olodaterol 2 mcg qd in the third period, Olodaterol 10 mcg qd in the fourth period and Olodaterol 5 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
135475|NCT01809262|P1|Participant Flow|Placebo / Olo 2mcg / Olo 20mcg / Olo 5mcg / Olo 10mcg|Patients were administered matching Placebo in the first period, Olodaterol 2 mcg qd in the second period, Olodaterol 20 mcg qd in the third period, Olodaterol 5 mcg qd in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
135476|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
135477|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
135478|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
135479|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
135480|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
135481|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
135482|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
135483|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
135484|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
135485|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
135486|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
135491|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
135492|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
135493|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
135494|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
135495|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
135496|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
135497|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
135498|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
135499|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
135500|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
135501|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
135502|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
135503|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
135504|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
135505|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
135506|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
135507|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
135508|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
135509|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
135510|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
135511|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
135512|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
135513|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
135514|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
135515|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
135516|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
135517|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
135518|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
135519|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
135520|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
135521|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
135522|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
135523|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
135524|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
135525|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
135526|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
135527|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
135528|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
135529|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
135530|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
135531|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
135532|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
135533|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
135534|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
135535|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
135536|NCT01809262|E5|Reported Event|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
135537|NCT01809262|E4|Reported Event|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
135538|NCT01809262|E3|Reported Event|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
135539|NCT01809262|E2|Reported Event|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
135540|NCT01809262|E1|Reported Event|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
135541|NCT01809210|B8|Baseline|Total|Total of all reporting groups
135542|NCT01809210|B7|Baseline|Cohort 7 sel100, Pem, Carb|selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135543|NCT01809210|B6|Baseline|Cohort 6 sel75, Pem, Cis|selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
135544|NCT01809210|B5|Baseline|Cohort 5 sel75, Pem, Carb|selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135545|NCT01809210|B4|Baseline|Cohort 4 sel150, Pem, Carb|selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135546|NCT01809210|B3|Baseline|Cohort 3 sel75, Gem, Cis|selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
135547|NCT01809210|B2|Baseline|Cohort 2 sel50, Gem, Carb|selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
135548|NCT01809210|B1|Baseline|Cohort 1 sel50, Gem, Cis|selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
135549|NCT01809210|P7|Participant Flow|Cohort 7 sel100, Pem, Carb|selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135550|NCT01809210|P6|Participant Flow|Cohort 6 sel75, Pem, Cis|selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
135551|NCT01809210|P5|Participant Flow|Cohort 5 sel75, Pem, Carb|selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135552|NCT01809210|P4|Participant Flow|Cohort 4 sel150, Pem, Carb|selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135553|NCT01809210|P3|Participant Flow|Cohort 3 sel75, Gem, Cis|selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
135554|NCT01809210|P2|Participant Flow|Cohort 2 sel50, Gem, Carb|selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
135555|NCT01809210|P1|Participant Flow|Cohort 1 sel50, Gem, Cis|selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
135556|NCT01809210|O7|Outcome|Cohort 7 sel100, Pem, Carb|selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135557|NCT01809210|O6|Outcome|Cohort 6 sel75, Pem, Cis|selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
135558|NCT01809210|O5|Outcome|Cohort 5 sel75, Pem, Carb|selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135559|NCT01809210|O4|Outcome|Cohort 4 sel150, Pem, Carb|selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135560|NCT01809210|O3|Outcome|Cohort 3 sel75, Gem, Cis|selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
135561|NCT01809210|O2|Outcome|Cohort 2 sel50, Gem, Carb|selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
135562|NCT01809210|O1|Outcome|Cohort 1 sel50, Gem, Cis|selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
135563|NCT01809210|O7|Outcome|Cohort 7 sel100, Pem, Carb|selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135564|NCT01809210|O6|Outcome|Cohort 6 sel75, Pem, Cis|selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
135565|NCT01809210|O5|Outcome|Cohort 5 sel75, Pem, Carb|selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135566|NCT01809210|O4|Outcome|Cohort 4 sel150, Pem, Carb|selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135567|NCT01809210|O3|Outcome|Cohort 3 sel75, Gem, Cis|selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
135568|NCT01809210|O2|Outcome|Cohort 2 sel50, Gem, Carb|selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
135569|NCT01809210|O1|Outcome|Cohort 1 sel50, Gem, Cis|selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
135570|NCT01809210|O7|Outcome|Cohort 7 sel100, Pem, Carb|selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135571|NCT01809210|O6|Outcome|Cohort 6 sel75, Pem, Cis|selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
135572|NCT01809210|O5|Outcome|Cohort 5 sel75, Pem, Carb|selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135573|NCT01809210|O4|Outcome|Cohort 4 sel150, Pem, Carb|selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135574|NCT01809210|O3|Outcome|Cohort 3 sel75, Gem, Cis|selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
135575|NCT01809210|O2|Outcome|Cohort 2 sel50, Gem, Carb|selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
135576|NCT01809210|O1|Outcome|Cohort 1 sel50, Gem, Cis|selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
135577|NCT01809210|O7|Outcome|Cohort 7 sel100, Pem, Carb|selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135578|NCT01809210|O6|Outcome|Cohort 6 sel75, Pem, Cis|selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
135579|NCT01809210|O5|Outcome|Cohort 5 sel75, Pem, Carb|selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135580|NCT01809210|O4|Outcome|Cohort 4 sel150, Pem, Carb|selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135581|NCT01809210|O3|Outcome|Cohort 3 sel75, Gem, Cis|selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
135582|NCT01809210|O2|Outcome|Cohort 2 sel50, Gem, Carb|selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
135583|NCT01809210|O1|Outcome|Cohort 1 sel50, Gem, Cis|selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
135584|NCT01809210|O7|Outcome|Cohort 7 sel100, Pem, Carb|selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135585|NCT01809210|O6|Outcome|Cohort 6 sel75, Pem, Cis|selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
135586|NCT01809210|O5|Outcome|Cohort 5 sel75, Pem, Carb|selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135587|NCT01809210|O4|Outcome|Cohort 4 sel150, Pem, Carb|selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135588|NCT01809210|O3|Outcome|Cohort 3 sel75, Gem, Cis|selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
135589|NCT01809210|O2|Outcome|Cohort 2 sel50, Gem, Carb|selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
135590|NCT01809210|O1|Outcome|Cohort 1 sel50, Gem, Cis|selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
135591|NCT01809210|O7|Outcome|Cohort 7 sel100, Pem, Carb|selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135592|NCT01809210|O6|Outcome|Cohort 6 sel75, Pem, Cis|selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
135593|NCT01809210|O5|Outcome|Cohort 5 sel75, Pem, Carb|selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135594|NCT01809210|O4|Outcome|Cohort 4 sel150, Pem, Carb|selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135595|NCT01809210|O3|Outcome|Cohort 3 sel75, Gem, Cis|selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
135596|NCT01809210|O2|Outcome|Cohort 2 sel50, Gem, Carb|selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
135597|NCT01809210|O1|Outcome|Cohort 1 sel50, Gem, Cis|selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
135598|NCT01809210|O7|Outcome|Cohort 7 sel100, Pem, Carb|selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135599|NCT01809210|O6|Outcome|Cohort 6 sel75, Pem, Cis|selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
135600|NCT01809210|O5|Outcome|Cohort 5 sel75, Pem, Carb|selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135601|NCT01809210|O4|Outcome|Cohort 4 sel150, Pem, Carb|selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135602|NCT01809210|O3|Outcome|Cohort 3 sel75, Gem, Cis|selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
135603|NCT01809210|O2|Outcome|Cohort 2 sel50, Gem, Carb|selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
135768|NCT01808560|B4|Baseline|Total|Total of all reporting groups
135604|NCT01809210|O1|Outcome|Cohort 1 sel50, Gem, Cis|selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
135605|NCT01809210|O7|Outcome|Cohort 7 sel100, Pem, Carb|selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135606|NCT01809210|O6|Outcome|Cohort 6 sel75, Pem, Cis|selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
135607|NCT01809210|O5|Outcome|Cohort 5 sel75, Pem, Carb|selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135608|NCT01809210|O4|Outcome|Cohort 4 sel150, Pem, Carb|selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135609|NCT01809210|O3|Outcome|Cohort 3 sel75, Gem, Cis|selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
135610|NCT01809210|O2|Outcome|Cohort 2 sel50, Gem, Carb|selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
135611|NCT01809210|O1|Outcome|Cohort 1 sel50, Gem, Cis|selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
135612|NCT01809210|O7|Outcome|Cohort 7 sel100, Pem, Carb|selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135613|NCT01809210|O6|Outcome|Cohort 6 sel75, Pem, Cis|selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
135614|NCT01809210|O5|Outcome|Cohort 5 sel75, Pem, Carb|selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135615|NCT01809210|O4|Outcome|Cohort 4 sel150, Pem, Carb|selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135616|NCT01809210|O3|Outcome|Cohort 3 sel75, Gem, Cis|selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
135617|NCT01809210|O2|Outcome|Cohort 2 sel50, Gem, Carb|selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
135618|NCT01809210|O1|Outcome|Cohort 1 sel50, Gem, Cis|selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
135619|NCT01809210|E7|Reported Event|Cohort 7 sel100, Pem, Carb|selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135620|NCT01809210|E6|Reported Event|Cohort 6 sel75, Pem, Cis|selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
135621|NCT01809210|E5|Reported Event|Cohort 5 sel75, Pem, Carb|selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135622|NCT01809210|E4|Reported Event|Cohort 4 sel150, Pem, Carb|selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
135623|NCT01809210|E3|Reported Event|Cohort 3 sel75, Gem, Cis|selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
135624|NCT01809210|E2|Reported Event|Cohort 2 sel50, Gem, Carb|selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
135625|NCT01809210|E1|Reported Event|Cohort 1 sel50, Gem, Cis|selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
135626|NCT01809197|B3|Baseline|Total|Total of all reporting groups
135627|NCT01809197|B2|Baseline|Acuvue Oasys/Habitual MPS|Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
135628|NCT01809197|B1|Baseline|Air Optix/OFPM|Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
135629|NCT01809197|P2|Participant Flow|Acuvue Oasys/Habitual MPS|Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
135630|NCT01809197|P1|Participant Flow|Air Optix/OFPM|Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
135631|NCT01809197|O2|Outcome|Acuvue Oasys/Habitual MPS|Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
135632|NCT01809197|O1|Outcome|Air Optix/OFPM|Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
135633|NCT01809197|E2|Reported Event|Acuvue Oasys/Habitual MPS|Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
135634|NCT01809197|E1|Reported Event|Air Optix/OFPM|Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
135635|NCT01809106|B5|Baseline|Total|Total of all reporting groups
135636|NCT01809106|B4|Baseline|Fentanyl|Fentanyl: 25 microg/h
135637|NCT01809106|B3|Baseline|Buprenorphine|Buprenorphine: 35 microg/h
135638|NCT01809106|B2|Baseline|Oxycodone|Oxycodone: 40 mg /24 ore
135639|NCT01809106|B1|Baseline|Morphine|Morphine: 60 mg /24 ore
135640|NCT01809106|P4|Participant Flow|Fentanyl|Fentanyl: 25 microg/h
135641|NCT01809106|P3|Participant Flow|Buprenorphine|Buprenorphine: 35 microg/h
135642|NCT01809106|P2|Participant Flow|Oxycodone|Oxycodone: 40 mg /24 ore
135643|NCT01809106|P1|Participant Flow|Morphine|Morphine: 60 mg /24 ore
135644|NCT01809106|O4|Outcome|Fentanyl|Fentanyl: 25 microg/h
135645|NCT01809106|O3|Outcome|Buprenorphine|Buprenorphine: 35 microg/h
135646|NCT01809106|O2|Outcome|Oxycodone|Oxycodone: 40 mg /24 ore
135647|NCT01809106|O1|Outcome|Morphine|Morphine: 60 mg /24 ore
135648|NCT01809106|O4|Outcome|Fentanyl|Fentanyl: 25 microg/h
135649|NCT01809106|O3|Outcome|Buprenorphine|Buprenorphine: 35 microg/h
135650|NCT01809106|O2|Outcome|Oxycodone|Oxycodone: 40 mg /24 ore
135651|NCT01809106|O1|Outcome|Morphine|Morphine: 60 mg /24 ore
135652|NCT01809106|O4|Outcome|Fentanyl|Fentanyl: 25 microg/h
135653|NCT01809106|O3|Outcome|Buprenorphine|Buprenorphine: 35 microg/h
135654|NCT01809106|O2|Outcome|Oxycodone|Oxycodone: 40 mg /24 ore
135655|NCT01809106|O1|Outcome|Morphine|Morphine: 60 mg /24 ore
135656|NCT01809106|E4|Reported Event|Fentanyl|Fentanyl: 25 microg/h
135657|NCT01809106|E3|Reported Event|Buprenorphine|Buprenorphine: 35 microg/h
135658|NCT01809106|E2|Reported Event|Oxycodone|Oxycodone: 40 mg /24 ore
135659|NCT01809106|E1|Reported Event|Morphine|Morphine: 60 mg /24 ore
135660|NCT01809054|B3|Baseline|Total|Total of all reporting groups
135661|NCT01809054|B2|Baseline|Pneumatic Compression Stockings Arm|"Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.~Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)~Aspirin"
135662|NCT01809054|B1|Baseline|Arixtra Arm|"Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks~Arixtra~Aspirin"
135663|NCT01809054|P2|Participant Flow|Pneumatic Compression Stockings Arm|"Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.~Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)~Aspirin"
135664|NCT01809054|P1|Participant Flow|Arixtra Arm|"Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks~Arixtra~Aspirin"
135665|NCT01809054|O2|Outcome|Pneumatic Compression Stockings Arm|"Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.~Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)~Aspirin"
135666|NCT01809054|O1|Outcome|Arixtra Arm|"Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks~Arixtra~Aspirin"
135667|NCT01809054|O2|Outcome|Pneumatic Compression Stockings Arm|"Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.~Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)~Aspirin"
135668|NCT01809054|O1|Outcome|Arixtra Arm|"Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks~Arixtra~Aspirin"
135669|NCT01809054|E2|Reported Event|Pneumatic Compression Stockings Arm|"Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.~Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)~Aspirin"
135670|NCT01809054|E1|Reported Event|Arixtra Arm|"Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks~Arixtra~Aspirin"
135671|NCT01808963|B1|Baseline|Study Group|Respiratory Heat Loss Measured in Joules Per Minute
135672|NCT01808963|P1|Participant Flow|Study Group|Patients undergoing elective surgery requiring endotracheal intubation for anesthesia.
135673|NCT01808963|O1|Outcome|Study Group|Joules per minute
135674|NCT01808963|E1|Reported Event|Study Group|Respiratory Heat Loss Measured in Joules Per Minute
135675|NCT01808950|B4|Baseline|Total|Total of all reporting groups
135676|NCT01808950|B3|Baseline|0.06% Resiquimod Gel - C|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed~0.06% Resiquimod Gel - C"
135677|NCT01808950|B2|Baseline|0.06% Resiquimod Gel - B|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - B"
135678|NCT01808950|B1|Baseline|0.06% Resiquimod Gel - A|"60 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - A"
135679|NCT01808950|P3|Participant Flow|0.06% Resiquimod Gel - C|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed~0.06% Resiquimod Gel - C"
135680|NCT01808950|P2|Participant Flow|0.06% Resiquimod Gel - B|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - B"
135681|NCT01808950|P1|Participant Flow|0.06% Resiquimod Gel - A|"60 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - A"
135682|NCT01808950|O3|Outcome|0.06% Resiquimod Gel - C|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed~0.06% Resiquimod Gel - C: shave biopsy of BCC followed by single 100mg dose"
135683|NCT01808950|O2|Outcome|0.06% Resiquimod Gel - B|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation"
135684|NCT01808950|O1|Outcome|0.06% Resiquimod Gel - A|"60 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation"
135685|NCT01808950|O3|Outcome|0.06% Resiquimod Gel - C|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed~0.06% Resiquimod Gel - C"
135686|NCT01808950|O2|Outcome|0.06% Resiquimod Gel - B|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - B"
135687|NCT01808950|O1|Outcome|0.06% Resiquimod Gel - A|"60 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - A"
135688|NCT01808950|E3|Reported Event|0.06% Resiquimod Gel - C|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed~0.06% Resiquimod Gel - C"
135689|NCT01808950|E2|Reported Event|0.06% Resiquimod Gel - B|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - B"
136142|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
135690|NCT01808950|E1|Reported Event|0.06% Resiquimod Gel - A|"60 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - A"
135691|NCT01808755|B1|Baseline|All Study Participamts|D Mannose 1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks then Antibiotic : trimethoprim/sulfamethoxazole 160/800 mg; length of treatment: 5-7 days
135692|NCT01808755|P2|Participant Flow|Trimethoprim/Sulfamethoxazole First, Then D Mannose|Antibiotic : trimethoprim/sulfametoxazole 80 mg + 400 mg twice a day; length of treatment: 5-7 days then D Mannose 1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks
135693|NCT01808755|P1|Participant Flow|D Mannose First, Then Trimethoprim/Sulfamethoxazole|D Mannose 1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks then Antibiotic : trimethoprim/sulfametoxazole 80 mg + 400 mg twice a day; length of treatment: 5-7 days
135694|NCT01808755|O2|Outcome|Trimethoprim /Sulfamethoxazole First, Then D Mannose|trimethoprim/sulfametossazole 160/800 mg for 5-7 days then D Mannose 1 gr. every 8 hours for 2 weeks
135695|NCT01808755|O1|Outcome|D Mannose First, Then Trimethoprim /Sulfamethoxazole|1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks then Antibiotic : trimethoprim/sulfamethoxazole 160/800 mg; length of treatment: 5-7 days
135696|NCT01808755|E1|Reported Event|D Mannose Versus Antibiotic|"1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks~D Mannose : D Mannose versus oral antibiotic~Antibiotic : length of treatment: 5-7 days"
135697|NCT01808651|B4|Baseline|Total|Total of all reporting groups
135698|NCT01808651|B3|Baseline|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135699|NCT01808651|B2|Baseline|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135700|NCT01808651|B1|Baseline|PLA/FLX (Placebo/Fluoxetine)|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135701|NCT01808651|P3|Participant Flow|FLX40/FLX|"Period 1: Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine 20 to 40 mg capsules administered orally, once daily, for 52 weeks in Study B1Y-JE-HCLW.~Period 2: 2-week observation phase following discontinuation of fluoxetine."
135702|NCT01808651|P2|Participant Flow|FLX20/FLX|"Period 1: Participants randomized to fluoxetine 20 mg /day in Study B1Y-JE-HCLV and continued on fluoxetine 20 to 40 mg capsules administered orally, once daily, for 52 weeks in Study B1Y-JE-HCLW.~Period 2: 2-week observation phase following discontinuation of fluoxetine."
135703|NCT01808651|P1|Participant Flow|PLA/FLX|"Period 1: Participants (Pts) randomized to placebo in Study B1Y-JE-HCLV transitioned to fluoxetine 20 to 40 mg capsules administered orally, once daily, for 52 weeks in Study B1Y-JE-HCLW.~Period 2: 2-week observation phase following discontinuation (DC'd) of fluoxetine."
135704|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135705|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135706|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135707|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135708|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135709|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135710|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135711|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135712|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135713|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135714|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135715|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135716|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135717|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135718|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135719|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135720|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135721|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135722|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135723|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135724|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
136143|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
135725|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135726|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135727|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135728|NCT01808651|E6|Reported Event|Study Period 2 Discontinued From FLX40/FLX|Participants in the FLX40/FLX group in Study Period 1, and discontinuing from fluoxetine in Study Period 2.
135729|NCT01808651|E5|Reported Event|Study Period 2 Discontinued From FLX20/FLX|Participants in the FLX20/FLX group in Study Period 1, and discontinuing from fluoxetine in Study Period 2.
135730|NCT01808651|E4|Reported Event|Study Period 2 Discontinued From PLA/FLX|Participants in the PLA/FLX group in Study Period 1, and discontinuing from fluoxetine in Study Period 2,
135731|NCT01808651|E3|Reported Event|Study Period 1 FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135732|NCT01808651|E2|Reported Event|Study Period 1 FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135733|NCT01808651|E1|Reported Event|Study Period 1 PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
135734|NCT01808612|B4|Baseline|Total|Total of all reporting groups
135735|NCT01808612|B3|Baseline|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
135736|NCT01808612|B2|Baseline|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
135737|NCT01808612|B1|Baseline|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
135738|NCT01808612|P3|Participant Flow|Placebo|"Treatment Period: placebo (capsules) administered orally, once daily, for 6 weeks~Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks"
135739|NCT01808612|P2|Participant Flow|40 mg Fluoxetine|"Treatment Period: 40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks~Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks"
135740|NCT01808612|P1|Participant Flow|20 mg Fluoxetine|"Treatment Period: 20 milligrams (mg) fluoxetine (capsules) administered orally, once daily, for 6 weeks~Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks"
135741|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
135742|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
135743|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
135744|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
135745|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
135746|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
135747|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
135748|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
135749|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
135750|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
135751|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
135752|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
135753|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
135754|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
135755|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
135756|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
135757|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
135758|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
135759|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
135760|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
135761|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
135762|NCT01808612|E6|Reported Event|Placebo (Discontinuation From 40 mg Fluoxetine)|AEs which occurred during the Discontinuation Period for participants who received 40 mg fluoxetine during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period
135763|NCT01808612|E5|Reported Event|Placebo (Discontinuation From 20 mg Fluoxetine)|AEs which occurred during the Discontinuation Period for participants who received 20 mg fluoxetine during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period
135764|NCT01808612|E4|Reported Event|Placebo (Discontinuation From Placebo)|AEs which occurred during the Discontinuation Period for participants who received placebo during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period
135765|NCT01808612|E3|Reported Event|40 mg Fluoxetine (Treatment Period)|AEs which occurred during the Treatment Period for participants who received 40 mg fluoxetine administered orally, once daily, for 6 weeks during the Treatment Period
135766|NCT01808612|E2|Reported Event|20 mg Fluoxetine (Treatment Period)|AEs which occurred during the Treatment Period for participants who received 20 mg fluoxetine administered orally, once daily, for 6 weeks during the Treatment Period
135767|NCT01808612|E1|Reported Event|Placebo (Treatment Period)|Adverse events (AEs) which occurred during the Treatment Period for participants who received placebo administered orally, once daily, for 6 weeks during the Treatment Period
135769|NCT01808560|B3|Baseline|LipiFlow Post-treatment|"Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery.~LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
135770|NCT01808560|B2|Baseline|Untreated Control|Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.
135771|NCT01808560|B1|Baseline|LipiFlow Pre-treatment|"Subjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery.~LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
135772|NCT01808560|P3|Participant Flow|LipiFlow Post-treatment|"Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery.~LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
135773|NCT01808560|P2|Participant Flow|Untreated Control|Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.
135774|NCT01808560|P1|Participant Flow|LipiFlow Pre-treatment|"Subjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery.~LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
135775|NCT01808560|O3|Outcome|LipiFlow Post-treatment|"Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery.~LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
135776|NCT01808560|O2|Outcome|Untreated Control|Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.
135777|NCT01808560|O1|Outcome|LipiFlow Pre-treatment|"Subjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery.~LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
135778|NCT01808560|O3|Outcome|LipiFlow Post-treatment|"Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery.~LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
135779|NCT01808560|O2|Outcome|Untreated Control|Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.
135780|NCT01808560|O1|Outcome|LipiFlow Pre-treatment|"Subjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery.~LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
135781|NCT01808560|O3|Outcome|LipiFlow Post-treatment|"Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery.~LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
135782|NCT01808560|O2|Outcome|Untreated Control|Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.
135783|NCT01808560|O1|Outcome|LipiFlow Pre-treatment|"Subjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery.~LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
135784|NCT01808560|O3|Outcome|LipiFlow Post-treatment|"Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery.~LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
135785|NCT01808560|O2|Outcome|Untreated Control|Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.
135786|NCT01808560|O1|Outcome|LipiFlow Pre-treatment|"Subjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery.~LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
135817|NCT01808508|P3|Participant Flow|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
136049|NCT01808118|O2|Outcome|Double-blind Adalimumab (Period 2)|Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.
135787|NCT01808560|O3|Outcome|LipiFlow Post-treatment|"Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery.~LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
135788|NCT01808560|O2|Outcome|Untreated Control|Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.
135789|NCT01808560|O1|Outcome|LipiFlow Pre-treatment|"Subjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery.~LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
135790|NCT01808560|O3|Outcome|LipiFlow Post-treatment|"Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery.~LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
135791|NCT01808560|O2|Outcome|Untreated Control|Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.
135792|NCT01808560|O1|Outcome|LipiFlow Pre-treatment|"Subjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery.~LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
135793|NCT01808560|E3|Reported Event|LipiFlow Post-treatment|"Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery.~LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
135794|NCT01808560|E2|Reported Event|Untreated Control|Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.
135795|NCT01808560|E1|Reported Event|LipiFlow Pre-treatment|"Subjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery.~LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."
135796|NCT01808547|B3|Baseline|Total|Total of all reporting groups
135797|NCT01808547|B2|Baseline|Vehicle|DuraSite vehicle dosed BID
135798|NCT01808547|B1|Baseline|ISV-303|0.075% bromfenac in DuraSite dosed BID
135799|NCT01808547|P2|Participant Flow|Vehicle|DuraSite vehicle dosed BID
135800|NCT01808547|P1|Participant Flow|ISV-303|0.075% bromfenac in DuraSite dosed BID
135801|NCT01808547|O2|Outcome|Vehicle|DuraSite vehicle dosed BID
135802|NCT01808547|O1|Outcome|ISV-303|0.075% bromfenac in DuraSite dosed BID
135803|NCT01808547|E2|Reported Event|Vehicle|DuraSite vehicle dosed BID
135804|NCT01808547|E1|Reported Event|ISV-303|0.075% bromfenac in DuraSite dosed BID
135805|NCT01808534|B1|Baseline|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
135806|NCT01808534|P1|Participant Flow|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
135807|NCT01808534|O1|Outcome|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
135808|NCT01808534|O1|Outcome|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
135809|NCT01808534|O1|Outcome|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
135810|NCT01808534|O1|Outcome|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
135811|NCT01808534|O1|Outcome|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
135812|NCT01808534|E1|Reported Event|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
135813|NCT01808508|B4|Baseline|Total|Total of all reporting groups
135814|NCT01808508|B3|Baseline|Group 3 - No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group
135815|NCT01808508|B2|Baseline|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.~Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.~This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
135816|NCT01808508|B1|Baseline|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.~Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
135818|NCT01808508|P2|Participant Flow|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.~Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.~This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
135819|NCT01808508|P1|Participant Flow|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.~Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
135820|NCT01808508|O3|Outcome|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
135821|NCT01808508|O2|Outcome|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.~Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.~This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
135822|NCT01808508|O1|Outcome|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.~Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
135823|NCT01808508|O3|Outcome|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
135824|NCT01808508|O2|Outcome|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.~Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.~This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
135825|NCT01808508|O1|Outcome|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.~Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
135826|NCT01808508|O3|Outcome|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
135827|NCT01808508|O2|Outcome|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.~Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.~This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
135828|NCT01808508|O1|Outcome|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.~Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
135829|NCT01808508|O3|Outcome|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
135830|NCT01808508|O2|Outcome|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.~Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.~This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
135831|NCT01808508|O1|Outcome|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.~Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
135832|NCT01808508|E3|Reported Event|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
135833|NCT01808508|E2|Reported Event|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.~Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.~This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
135834|NCT01808508|E1|Reported Event|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.~Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
135835|NCT01808339|B1|Baseline|FF 100 µg AM/FF 100 µg PM/Placebo|Participants received 3 treatments (A, B, and C) in either of the six sequences: ABC , ACB, BAC, BCA, CAB, or CBA. During treatment A participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI), during treatment B: participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI during treatment C: participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135836|NCT01808339|P6|Participant Flow|Placebo/FF 100 µg PM /FF 100 µg AM|Participants received 3 treatments (A, B, and C) in sequence CBA. During treatment A participants received FF 100 µg in the AM at approximately 09:00 and received placebo in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI. During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135854|NCT01808339|E3|Reported Event|Placebo|Participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135837|NCT01808339|P5|Participant Flow|Placebo/FF 100 µg AM/FF 100 µg PM|Participants received 3 treatments (A, B, and C) in sequence CAB. During treatment A participants received FF 100 µg in the AM at approximately 09:00 and received placebo in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI. During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135838|NCT01808339|P4|Participant Flow|FF 100 µg PM /Placebo/FF 100 µg AM|Participants received 3 treatments (A, B, and C) in sequence BCA. During treatment A participants received FF 100 µg in the AM at approximately 09:00 and received placebo in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI. During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135839|NCT01808339|P3|Participant Flow|FF 100 µg PM /FF 100 µg AM/Placebo|Participants received 3 treatments (A, B, and C) in sequence BAC. During treatment A participants received FF 100 µg in the AM at approximately 09:00 and received placebo in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI. During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135840|NCT01808339|P2|Participant Flow|FF 100 µg AM/Placebo/FF 100 µg PM|Participants received 3 treatments (A, B, and C) in sequence ACB. During treatment A participants received FF 100 µg in the AM at approximately 09:00 and received placebo in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI. During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135841|NCT01808339|P1|Participant Flow|FF 100 µg AM /FF 100 µg PM/Placebo|Participants received 3 treatments (A, B, and C) in sequence ABC. During treatment A participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI). During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135842|NCT01808339|O3|Outcome|Placebo|Participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135843|NCT01808339|O2|Outcome|FF 100 µg PM|Participants received placebo in the AM at approximately 09:00 and FF 100 µg in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135844|NCT01808339|O1|Outcome|FF 100 µg AM|Participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI) in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135845|NCT01808339|O3|Outcome|Placebo|Participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135846|NCT01808339|O2|Outcome|FF 100 µg PM|Participants received placebo in the AM at approximately 09:00 and FF 100 µg in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135847|NCT01808339|O1|Outcome|FF 100 µg AM|Participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI) in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135848|NCT01808339|O3|Outcome|Placebo|Participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135849|NCT01808339|O2|Outcome|FF 100 µg PM|Participants received placebo in the AM at approximately 09:00 and FF 100 µg in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135850|NCT01808339|O1|Outcome|FF 100 µg AM|Participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI) in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135851|NCT01808339|O3|Outcome|Placebo|Participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135852|NCT01808339|O2|Outcome|FF 100 µg PM|Participants received placebo in the AM at approximately 09:00 and FF 100 µg in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135853|NCT01808339|O1|Outcome|FF 100 µg AM|Participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI) in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
157784|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
135855|NCT01808339|E2|Reported Event|FF 100 µg PM|Participants received placebo in the AM at approximately 09:00 and FF 100 µg in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135856|NCT01808339|E1|Reported Event|FF 100 µg AM|Participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI) in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135857|NCT01808326|B1|Baseline|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135858|NCT01808326|P1|Participant Flow|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135859|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135860|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135861|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135862|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135885|NCT01808313|P1|Participant Flow|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
135886|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
157785|NCT01717989|O4|Outcome|Q3 2011|Third quarter, 2011
135863|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135864|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135865|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135866|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135867|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135868|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135869|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135887|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
136050|NCT01808118|O1|Outcome|Placebo (Period 2)|Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.
135870|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135871|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135872|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135873|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135874|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135875|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135876|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135888|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
136136|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
135877|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135878|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135879|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135880|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135881|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135882|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135883|NCT01808326|E1|Reported Event|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
135884|NCT01808313|B1|Baseline|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
136137|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
157786|NCT01717989|O3|Outcome|Q2 2011|Second quarter, 2011
135889|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
135890|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
135891|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
135892|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
135893|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
135894|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
135895|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
135896|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
135897|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
135898|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
135899|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
135900|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
135901|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
135902|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
135903|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
135904|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
135905|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
135906|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
135907|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
135908|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
135909|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
135910|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
135911|NCT01808313|E1|Reported Event|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
135912|NCT01808261|B3|Baseline|Total|Total of all reporting groups
136138|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
135913|NCT01808261|B2|Baseline|GSK249320 15 mg/kg|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
135914|NCT01808261|B1|Baseline|Placebo|Participants were administered placebo as two IV infusions, the first on Study Day 1 which was 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL, IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
135915|NCT01808261|P2|Participant Flow|GSK249320 15 mg/kg|Participants received GSK249320 15 milligrams (mg)/kilogram (kg) administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
135916|NCT01808261|P1|Participant Flow|Placebo|Participants received placebo administered as two intravenous (IV) infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 milliliters (mL) IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
135917|NCT01808261|O2|Outcome|GSK249320 15 mg/kg - Safety|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135918|NCT01808261|O1|Outcome|Placebo - Safety|Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135919|NCT01808261|O1|Outcome|GSK249320 15 mg/kg - PK|Participants received GSK249320 15 mg/kg, administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). PK population consisted of all participants in the Safety population who have at least one PK sample with a concentration above the non-quantifiable limit.
135920|NCT01808261|O1|Outcome|GSK249320 15 mg/kg - PK|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). PK population consisted of all participants in the Safety population who have at least one PK sample with a concentration above the non-quantifiable limit.
135921|NCT01808261|O1|Outcome|GSK249320 15 mg/kg – PK|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). PK population consisted of all participants in the Safety population who have at least one PK sample with a concentration above the non-quantifiable limit.
135922|NCT01808261|O1|Outcome|GSK249320 15 mg/kg - PK|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
135923|NCT01808261|O1|Outcome|GSK249320 15 mg/kg - PK|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). PK population consisted of all participants in the Safety population who have at least one PK sample with a concentration above the non-quantifiable limit.
135924|NCT01808261|O1|Outcome|GSK249320 15 mg/kg - PK|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). PK population consisted of all participants in the Safety population who have at least one PK sample with a concentration above the non-quantifiable limit.
135925|NCT01808261|O2|Outcome|GSK249320 15 mg/kg - Safety|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135926|NCT01808261|O1|Outcome|Placebo - Safety|Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135927|NCT01808261|O2|Outcome|GSK249320 15 mg/kg - Safety|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135928|NCT01808261|O1|Outcome|Placebo - Safety|Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135985|NCT01808209|B1|Baseline|Stenfilcon A Then Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
135929|NCT01808261|O2|Outcome|GSK249320 15 mg/kg - Safety|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135930|NCT01808261|O1|Outcome|Placebo - Safety|Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product
135931|NCT01808261|O2|Outcome|GSK249320 15 mg/kg - Safety|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135932|NCT01808261|O1|Outcome|Placebo - Safety|Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135933|NCT01808261|O2|Outcome|GSK249320 15 mg/kg - Safety|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135934|NCT01808261|O1|Outcome|Placebo - Safety|Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135935|NCT01808261|O2|Outcome|GSK249320 15 mg/kg - Safety|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135936|NCT01808261|O1|Outcome|Placebo - Safety|Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135937|NCT01808261|O2|Outcome|GSK249320 15 mg/kg - Safety|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135938|NCT01808261|O1|Outcome|Placebo - Safety|Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135939|NCT01808261|O2|Outcome|GSK249320 15 mg/kg - Safety|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135940|NCT01808261|O1|Outcome|Placebo - Safety|Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135941|NCT01808261|O2|Outcome|GSK249320 15 mg/kg - Safety|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135942|NCT01808261|O1|Outcome|Placebo - Safety|Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135943|NCT01808261|O2|Outcome|GSK249320 15 mg/kg - Safety|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135944|NCT01808261|O1|Outcome|Placebo - Safety|Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
136139|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
135945|NCT01808261|O2|Outcome|GSK249320 15 mg/kg - Safety|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135946|NCT01808261|O1|Outcome|Placebo - Safety|Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135947|NCT01808261|O2|Outcome|GSK249320 15 mg/kg - Safety|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135948|NCT01808261|O1|Outcome|Placebo - Safety|Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135949|NCT01808261|O2|Outcome|GSK249320 15 mg/kg - Safety|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135950|NCT01808261|O1|Outcome|Placebo - Safety|Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135951|NCT01808261|O2|Outcome|GSK249320 15/mg|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
135952|NCT01808261|O1|Outcome|Placebo|Participants were administered placebo as two IV infusions, the first on Study Day 1 which was 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL, IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
135953|NCT01808261|O2|Outcome|GSK249320 15/mg|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
135954|NCT01808261|O1|Outcome|Placebo|Participants were administered placebo as two IV infusions, the first on Study Day 1 which was 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL, IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
135955|NCT01808261|O2|Outcome|GSK249320 15 mg/kg - Safety|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135956|NCT01808261|O1|Outcome|Placebo - Safety|Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135957|NCT01808261|O2|Outcome|GSK249320 15 mg/kg - Safety|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135958|NCT01808261|O1|Outcome|Placebo - Safety|Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
135959|NCT01808261|O2|Outcome|GSK249320 15 mg/kg - PP|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The GSK249320 15 mg/kg - PP Population consisted of all participants who were included in the ITT population and did not violate protocol with regards to inclusion/exclusion criteria, unblinding, investigational product administration and gait velocity assessments.
135960|NCT01808261|O1|Outcome|Placebo - PP|Participants were administered placebo as two IV infusions, the first on Study Day 1 which was 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL, IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). Placebo PP Population consisted of all participants who were included in the ITT population and did not violate protocol with regards to inclusion/exclusion criteria, unblinding, investigational product administration and gait velocity assessments.
136011|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
135961|NCT01808261|O2|Outcome|GSK249320 15 mg/kg - PP|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The GSK249320 15 mg/kg - PP Population consisted of all participants who were included in the ITT population and did not violate protocol with regards to inclusion/exclusion criteria, unblinding, investigational product administration and gait velocity assessments.
135962|NCT01808261|O1|Outcome|Placebo - PP|Participants were administered placebo as two IV infusions, the first on Study Day 1 which was 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL, IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). Placebo - Per Protocol (PP) Population consisted of all participants who were included in the ITT population and did not violate protocol with regards to inclusion/exclusion criteria, unblinding, investigational product administration and gait velocity assessments.
135963|NCT01808261|O2|Outcome|GSK249320 15 mg/kg|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
135964|NCT01808261|O1|Outcome|Placebo|Participants were administered placebo as two IV infusions, the first on Study Day 1 which was 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL, IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
135965|NCT01808261|O2|Outcome|GSK249320 15 mg/kg|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
135966|NCT01808261|O1|Outcome|Placebo|Participants were administered placebo as two IV infusions, the first on Study Day 1 which was 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL, IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
135967|NCT01808261|E2|Reported Event|GSK249320 15 mg/kg|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
135968|NCT01808261|E1|Reported Event|Placebo|Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL, IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
135969|NCT01808248|B3|Baseline|Total|Total of all reporting groups
135970|NCT01808248|B2|Baseline|Genotype 3|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
135971|NCT01808248|B1|Baseline|Genotype 2|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 hepatitis C virus (HCV) infection.
135972|NCT01808248|P1|Participant Flow|SOF+PEG+RBV|Sofosbuvir (SOF) 400 mg tablet once daily + peginterferon alfa 2a (PEG) 180 μg subcutaneous injection once weekly + weight-based ribavirin (RBV; 1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
135973|NCT01808248|O2|Outcome|Genotype 3|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
135974|NCT01808248|O1|Outcome|Genotype 2|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
135975|NCT01808248|O2|Outcome|Genotype 3|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
135976|NCT01808248|O1|Outcome|Genotype 2|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
135977|NCT01808248|O2|Outcome|Genotype 3|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
135978|NCT01808248|O1|Outcome|Genotype 2|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
135979|NCT01808248|O1|Outcome|SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
135980|NCT01808248|O2|Outcome|Genotype 3|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
135981|NCT01808248|O1|Outcome|Genotype 2|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
135982|NCT01808248|E1|Reported Event|SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
135983|NCT01808209|B3|Baseline|Total|Total of all reporting groups
135984|NCT01808209|B2|Baseline|Filcon II 3 Then Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
136048|NCT01808118|O1|Outcome|Placebo (Period 2)|Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.
157787|NCT01717989|O2|Outcome|Q1 2011|First quarter 2011
135986|NCT01808209|P2|Participant Flow|Filcon II 3 Then Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair worn one week.
135987|NCT01808209|P1|Participant Flow|Stenfilcon A Then Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
135988|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
135989|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
135990|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair worn one week.
135991|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
135992|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair worn one week.
135993|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
135994|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses.
135995|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair worn one week.
135996|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
135997|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses.
135998|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair worn one week.
135999|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
136000|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
136001|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
136002|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
136003|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
136004|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses..
136005|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
136006|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
136007|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses..
136008|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
136009|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
136010|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses.
136012|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
136013|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses.
136014|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
136015|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
136016|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses.
136017|NCT01808209|O1|Outcome|Habitual Lens|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair was worn one week.
136018|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
136019|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
136020|NCT01808209|O1|Outcome|Habitual Lens|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair was worn one week.
136021|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
136022|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
136023|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
136024|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
136025|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses.
136026|NCT01808209|E2|Reported Event|Filcon II 3|All participants completing the study wore both sets of study lenses.Participants were randomized to wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
136027|NCT01808209|E1|Reported Event|Stenfilcon A|All participants completing the study wore both sets of study lenses.Participants were randomized to wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
136028|NCT01808144|B3|Baseline|Total|Total of all reporting groups
136029|NCT01808144|B2|Baseline|Lesinurad 200 mg + Febuxostat 80 mg|
136030|NCT01808144|B1|Baseline|Lesinurad 400 mg + Febuxostat 80 mg|
136031|NCT01808144|P2|Participant Flow|Lesinurad 400 mg + Febuxostat 80 mg|
136032|NCT01808144|P1|Participant Flow|Lesinurad 200 mg + Febuxostat 80 mg|
136033|NCT01808144|O2|Outcome|Lesinurad 200 mg + Febuxostat 80 mg|
136034|NCT01808144|O1|Outcome|Lesinurad 400 mg + Febuxostat 80 mg|
136035|NCT01808144|O2|Outcome|Lesinurad 200 mg + Febuxostat 80 mg|
136036|NCT01808144|O1|Outcome|Lesinurad 400 mg + Febuxostat 80 mg|
136037|NCT01808144|E2|Reported Event|Lesinurad 400 mg + Febuxostat 80 mg|
136038|NCT01808144|E1|Reported Event|Lesinurad 200 mg + Febuxostat 80 mg|
136039|NCT01808118|B1|Baseline|Open-label (OL) Adalimumab (Period 1)|40 mg every other week (eow), Weeks 0-28.
136040|NCT01808118|P3|Participant Flow|Double-blind Adalimumab (Period 2)|Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.
136041|NCT01808118|P2|Participant Flow|Placebo (Period 2)|Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.
136042|NCT01808118|P1|Participant Flow|Open-label (OL) Adalimumab (Period 1)|40 mg every other week (eow), Weeks 0-28.
136043|NCT01808118|O2|Outcome|Double-blind Adalimumab (Period 2)|Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.
136044|NCT01808118|O1|Outcome|Placebo (Period 2)|Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.
136045|NCT01808118|O2|Outcome|Double-blind Adalimumab (Period 2)|Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.
136046|NCT01808118|O1|Outcome|Placebo (Period 2)|Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.
136047|NCT01808118|O2|Outcome|Double-blind Adalimumab (Period 2)|Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.
136525|NCT01806857|E1|Reported Event|Active Drug (Neudexta)|Includes all subjects that took the active drug (Neudexta)
136051|NCT01808118|O3|Outcome|Double-blind Adalimumab (Period 2)|Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.
136052|NCT01808118|O2|Outcome|Placebo (Period 2)|Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.
136053|NCT01808118|O1|Outcome|Open-label (OL) Adalimumab (Period 1)|40 mg every other week (eow), Weeks 0-28.
136054|NCT01808118|O3|Outcome|Double-blind Adalimumab (Period 2)|Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.
136055|NCT01808118|O2|Outcome|Placebo (Period 2)|Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.
136056|NCT01808118|O1|Outcome|Open-label (OL) Adalimumab (Period 1)|40 mg every other week (eow), Weeks 0-28.
136057|NCT01808118|O3|Outcome|Double-blind Adalimumab (Period 2)|Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.
136058|NCT01808118|O2|Outcome|Placebo (Period 2)|Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.
136059|NCT01808118|O1|Outcome|Open-label (OL) Adalimumab (Period 1)|40 mg every other week (eow), Weeks 0-28.
136060|NCT01808118|O3|Outcome|Double-blind Adalimumab (Period 2)|Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.
136061|NCT01808118|O2|Outcome|Placebo (Period 2)|Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.
136062|NCT01808118|O1|Outcome|Open-label (OL) Adalimumab (Period 1)|40 mg every other week (eow), Weeks 0-28.
136063|NCT01808118|O3|Outcome|Double-blind Adalimumab (Period 2)|Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.
136064|NCT01808118|O2|Outcome|Placebo (Period 2)|Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.
136065|NCT01808118|O1|Outcome|Open-label (OL) Adalimumab (Period 1)|40 mg every other week (eow), Weeks 0-28.
136066|NCT01808118|O3|Outcome|Double-blind Adalimumab (Period 2)|Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.
136067|NCT01808118|O2|Outcome|Placebo (Period 2)|Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.
136068|NCT01808118|O1|Outcome|Open-label (OL) Adalimumab (Period 1)|40 mg every other week (eow), Weeks 0-28.
136069|NCT01808118|O3|Outcome|Double-blind Adalimumab (Period 2)|Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.
136070|NCT01808118|O2|Outcome|Placebo (Period 2)|Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.
136071|NCT01808118|O1|Outcome|Open-label (OL) Adalimumab (Period 1)|40 mg every other week (eow), Weeks 0-28.
136072|NCT01808118|O3|Outcome|Double-blind Adalimumab (Period 2)|Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.
136073|NCT01808118|O2|Outcome|Placebo (Period 2)|Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.
136074|NCT01808118|O1|Outcome|Open-label (OL) Adalimumab (Period 1)|40 mg every other week (eow), Weeks 0-28.
136075|NCT01808118|O3|Outcome|Double-blind Adalimumab (Period 2)|Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.
136076|NCT01808118|O2|Outcome|Placebo (Period 2)|Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.
136077|NCT01808118|O1|Outcome|Open-label (OL) Adalimumab (Period 1)|40 mg every other week (eow), Weeks 0-28.
136078|NCT01808118|O2|Outcome|Double-blind Adalimumab (Period 2)|Double-blind adalimumab participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.
136079|NCT01808118|O1|Outcome|Placebo (Period 2)|Placebo participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.
136080|NCT01808118|O2|Outcome|Double-blind Adalimumab (Period 2)|Placebo participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.
136081|NCT01808118|O1|Outcome|Placebo (Period 2)|Placebo participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.
136082|NCT01808118|O2|Outcome|Double-blind Adalimumab (Period 2)|Double-blind adalimumab participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.
136083|NCT01808118|O1|Outcome|Placebo (Period 2)|Placebo participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.
136084|NCT01808118|O2|Outcome|Double-blind Adalimumab (Period 2)|Double-blind adalimumab participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.
136085|NCT01808118|O1|Outcome|Placebo (Period 2)|Placebo participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.
136086|NCT01808118|O2|Outcome|Double-blind Adalimumab (Period 2)|Double-blind adalimumab participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.
136087|NCT01808118|O1|Outcome|Placebo (Period 2)|Placebo participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.
136088|NCT01808118|O2|Outcome|Double-blind Adalimumab (Period 2)|Double-blind adalimumab participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.
136089|NCT01808118|O1|Outcome|Placebo (Period 2)|Placebo participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.
136140|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136090|NCT01808118|O2|Outcome|Double-blind Adalimumab (Period 2)|Double-blind adalimumab participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.
136091|NCT01808118|O1|Outcome|Placebo (Period 2)|Placebo participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.
136092|NCT01808118|O2|Outcome|Double-blind Adalimumab (Period 2)|Double-blind adalimumab participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.
136093|NCT01808118|O1|Outcome|Placebo (Period 2)|Placebo participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.
136094|NCT01808118|O2|Outcome|Double-blind Adalimumab (Period 2)|Double-blind adalimumab participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.
136095|NCT01808118|O1|Outcome|Placebo (Period 2)|Placebo participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.
136096|NCT01808118|O2|Outcome|Double-blind Adalimumab (Period 2)|Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.
136097|NCT01808118|O1|Outcome|Placebo (Period 2)|Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.
136098|NCT01808118|E4|Reported Event|Any Adalimumab Population|The Any Adalimumab Population consisted of all participants who received at least 1 dose of adalimumab any time during the study (including the open-label period, double-blind period and rescue period).
136099|NCT01808118|E3|Reported Event|Double-blind Adalimumab (Period 2)|Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.
136100|NCT01808118|E2|Reported Event|Placebo (Period 2)|Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.
136101|NCT01808118|E1|Reported Event|Open-label (OL) Adalimumab (Period 1), Full Analysis Set|40 mg every other week (eow), Weeks 0-28. The Full Analysis Set included all participants who enrolled in the open-label period (Period 1) and received at least 1 dose of adalimumab.
136102|NCT01808092|B3|Baseline|Total|Total of all reporting groups
136103|NCT01808092|B2|Baseline|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136104|NCT01808092|B1|Baseline|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136105|NCT01808092|P2|Participant Flow|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136106|NCT01808092|P1|Participant Flow|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136107|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136108|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136109|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136110|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136111|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136112|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136113|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136114|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136115|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136116|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136117|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136118|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136119|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136120|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136121|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136122|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136123|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136124|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136125|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136126|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136127|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136128|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136129|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136130|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136131|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136132|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136133|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136134|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136135|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136144|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136145|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136146|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136147|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136148|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136149|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136150|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136151|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136152|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136153|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136154|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136155|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136156|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136157|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136158|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136159|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136160|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136161|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136162|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136163|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136164|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136165|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136166|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136167|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136168|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136169|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136170|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136171|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136172|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136173|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136174|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136175|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136176|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136177|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136178|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136179|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136180|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136181|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136182|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136183|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136184|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136185|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136186|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136187|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136188|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136189|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136190|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136191|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136192|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136193|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136194|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136195|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136196|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136197|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136198|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136199|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136200|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136201|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136202|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136203|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136204|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136205|NCT01808092|E2|Reported Event|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
136206|NCT01808092|E1|Reported Event|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
136207|NCT01808066|B1|Baseline|Play Groundskeeper|"This study will employ design-based research models (Laurel, 2003) to the executive-functioning training game GroundsKeeper by CogCubed; we will assess the quality of digital designs for learning (Barab & Squire, 2004) using established qualitative data collection to analyze game play and player reaction over a three week period of time.~Groundskeeper: Groundskeeper is a product developed for helping players develop skills to increase focus and attention. The game is played on small Sifteo Cubes that have sensors that react to you and each other. There are new games that might help children with ADHD and Autism learn to better focus and keep attention on a task."
136208|NCT01808066|P1|Participant Flow|Treatment Group|21 participants with ADHD who underwent the intervention for 3 weeks, played for 20 minutes at a time at school.
136209|NCT01808066|O1|Outcome|Play Groundskeeper|"This study will employ design-based research models (Laurel, 2003) to the executive-functioning training game GroundsKeeper by CogCubed; we will assess the quality of digital designs for learning (Barab & Squire, 2004) using established qualitative data collection to analyze game play and player reaction over a three week period of time.~Groundskeeper: Groundskeeper is a product developed for helping players develop skills to increase focus and attention. The game is played on small Sifteo Cubes that have sensors that react to you and each other. There are new games that might help children with ADHD and Autism learn to better focus and keep attention on a task."
136210|NCT01808066|E1|Reported Event|Treatment Group|21 participants with ADHD who underwent the intervention for 3 weeks, played for 20 minutes at a time at school.
136211|NCT01807949|B4|Baseline|Total|Total of all reporting groups
136212|NCT01807949|B3|Baseline|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136213|NCT01807949|B2|Baseline|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136214|NCT01807949|B1|Baseline|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136215|NCT01807949|P3|Participant Flow|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136216|NCT01807949|P2|Participant Flow|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 milligram (mg) plus IVA 250 mg fixed-dose combination (FDC) tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136217|NCT01807949|P1|Participant Flow|Placebo|Placebo matched to lumacaftor (LUM, VX-809) and ivacaftor (IVA, VX-770) tablet every 12 hours (q12h), up to Week 24.
136218|NCT01807949|O2|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136219|NCT01807949|O1|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136220|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136221|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136222|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136223|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136224|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136225|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136226|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136227|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136228|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136229|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136230|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136231|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136232|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136233|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136234|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136235|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136526|NCT01806779|B3|Baseline|Total|Total of all reporting groups
136236|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136237|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136238|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136239|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136240|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136241|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136242|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136243|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136244|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136245|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136246|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136247|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136248|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136249|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136250|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136251|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136252|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136253|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136254|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136255|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136256|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136257|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136258|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136259|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136260|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136261|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136262|NCT01807949|E3|Reported Event|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136263|NCT01807949|E2|Reported Event|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136264|NCT01807949|E1|Reported Event|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136265|NCT01807923|B4|Baseline|Total|Total of all reporting groups
136266|NCT01807923|B3|Baseline|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136267|NCT01807923|B2|Baseline|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136268|NCT01807923|B1|Baseline|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136269|NCT01807923|P3|Participant Flow|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136270|NCT01807923|P2|Participant Flow|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 milligram (mg) plus IVA 250 mg fixed-dose combination (FDC) tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136271|NCT01807923|P1|Participant Flow|Placebo|Placebo matched to lumacaftor (LUM, VX-809) and ivacaftor (IVA, VX-770) tablet every 12 hours (q12h), up to Week 24.
136272|NCT01807923|O2|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136273|NCT01807923|O1|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136274|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136275|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136276|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136277|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136278|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136279|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136280|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136281|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136282|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136283|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136284|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136285|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136286|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136287|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136288|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136289|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136290|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136291|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136292|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136293|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136294|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136295|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136296|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136297|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136298|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136299|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136300|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136301|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136302|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136303|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136304|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136305|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136306|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136307|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136308|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136309|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136310|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136311|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136312|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136313|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136314|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136315|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136316|NCT01807923|E3|Reported Event|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
136317|NCT01807923|E2|Reported Event|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
136318|NCT01807923|E1|Reported Event|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
136319|NCT01807871|B3|Baseline|Total|Total of all reporting groups
136320|NCT01807871|B2|Baseline|Nicotine Patch, Labeled Use|"Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.~nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling."
136321|NCT01807871|B1|Baseline|Nicotine Patch, Experimental Use|"Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.~nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch."
136322|NCT01807871|P2|Participant Flow|Nicotine Patch, Labeled Use|"Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.~nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling."
136323|NCT01807871|P1|Participant Flow|Nicotine Patch, Experimental Use|"Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.~nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch."
136324|NCT01807871|O2|Outcome|Nicotine Patch, Labeled Use|"Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.~nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling."
136325|NCT01807871|O1|Outcome|Nicotine Patch, Experimental Use|"Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.~nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch."
136326|NCT01807871|O2|Outcome|Nicotine Patch, Labeled Use|"Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.~nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling."
136327|NCT01807871|O1|Outcome|Nicotine Patch, Experimental Use|"Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.~nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch."
136328|NCT01807871|O2|Outcome|Nicotine Patch, Labeled Use|"Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.~nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling."
136329|NCT01807871|O1|Outcome|Nicotine Patch, Experimental Use|"Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.~nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch."
136330|NCT01807871|E2|Reported Event|Nicotine Patch, Labeled Use|"Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.~nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling."
136331|NCT01807871|E1|Reported Event|Nicotine Patch, Experimental Use|"Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.~nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch."
136332|NCT01807624|B1|Baseline|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
136333|NCT01807624|P1|Participant Flow|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
136334|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
136335|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
136336|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
136337|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
136338|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
136339|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
136340|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
136341|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
136342|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
136343|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
136463|NCT01806896|O2|Outcome|Placebo Twice a Day|Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
136344|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
136345|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
136346|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
136347|NCT01807624|E1|Reported Event|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
136348|NCT01807520|B4|Baseline|Total|Total of all reporting groups
136349|NCT01807520|B3|Baseline|Placebo|Participants who received placebo during treatment period 1
136350|NCT01807520|B2|Baseline|AIN457 300 mg|Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
136351|NCT01807520|B1|Baseline|AIN457 150 mg|Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
136352|NCT01807520|P7|Participant Flow|Any AIN457 300 mg|Participants who received AIN457 300 mg during treatment period 1 and/or treatment period 2
136353|NCT01807520|P6|Participant Flow|Any AIN457 150 mg|Participants who received AIN457 150 mg during treatment period 1 and/or treatment period 2
136354|NCT01807520|P5|Participant Flow|Placebo - AIN457 300 mg|Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 300 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.
136355|NCT01807520|P4|Participant Flow|Placebo - AIN457 150 mg|Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 150 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.
136356|NCT01807520|P3|Participant Flow|Placebo|Participants who received placebo during treatment period 1
136357|NCT01807520|P2|Participant Flow|AIN457 300 mg|Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
136358|NCT01807520|P1|Participant Flow|AIN457 150 mg|Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
136359|NCT01807520|O4|Outcome|Placebo - AIN457 300 mg|Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 300 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.
136360|NCT01807520|O3|Outcome|Placebo - AIN457 150 mg|Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 150 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.
136361|NCT01807520|O2|Outcome|AIN457 300 mg|Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
136362|NCT01807520|O1|Outcome|AIN457 150 mg|Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
136363|NCT01807520|O2|Outcome|AIN457 300 mg|Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
136364|NCT01807520|O1|Outcome|AIN457 150 mg|Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
136365|NCT01807520|O4|Outcome|Placebo - AIN457 300 mg|Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 300 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.
136366|NCT01807520|O3|Outcome|Placebo - AIN457 150 mg|Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 150 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.
136402|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo~Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136367|NCT01807520|O2|Outcome|AIN457 300 mg|Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
136368|NCT01807520|O1|Outcome|AIN457 150 mg|Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
136369|NCT01807520|O3|Outcome|Placebo|Participants who received placebo during treatment period 1
136370|NCT01807520|O2|Outcome|AIN457 300 mg|Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
136371|NCT01807520|O1|Outcome|AIN457 150 mg|Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
136372|NCT01807520|E4|Reported Event|Any AIN457 Dose|Participants who received AIN457 150 mg or AIN457 300 mg
136373|NCT01807520|E3|Reported Event|Placebo|Participants who received placebo during treatment period 1
136374|NCT01807520|E2|Reported Event|Any AIN457 300 mg|Participants who received AIN457 300 mg during treatment period 1 and/or treatment period 2
136375|NCT01807520|E1|Reported Event|Any AIN457 150 mg|Participants who received AIN457 150 mg during treatment period 1 and/or treatment period 2
136376|NCT01807455|B1|Baseline|Restylane Vital Lidocaine|Restylane Vital Lidocaine
136377|NCT01807455|P1|Participant Flow|Restylane Vital Lidocaine|Restylane Vital Lidocaine
136378|NCT01807455|O1|Outcome|Restylane Vital Lidocaine|Restylane Vital Lidocaine
136379|NCT01807455|O1|Outcome|Restylane Vital Lidocaine|Restylane Vital Lidocaine
136380|NCT01807455|O1|Outcome|Restylane Vital Lidocaine|Restylane Vital Lidocaine
136381|NCT01807455|O1|Outcome|Restylane Vital Lidocaine|Restylane Vital Lidocaine
136382|NCT01807455|O1|Outcome|Restylane Vital Lidocaine|Restylane Vital Lidocaine
136383|NCT01807455|E1|Reported Event|Restylane Vital Lidocaine|Restylane Vital Lidocaine
136384|NCT01807234|B7|Baseline|Total|Total of all reporting groups
136385|NCT01807234|B6|Baseline|Placebo Then Sumatriptan Then Ketorolac|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.~Attack 2: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.~Attack 3: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril."
136386|NCT01807234|B5|Baseline|Placebo Then Ketorolac Then Sumatriptan|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.~Attack 2: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.~Attack 3: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril."
136387|NCT01807234|B4|Baseline|Sumatriptan Then Placebo Then Ketorolac|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.~Attack 2: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.~Attack 3: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril."
136388|NCT01807234|B3|Baseline|Sumatriptan Then Ketorolac Then Placebo|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.~Attack 2: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.~Attack 3: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril."
136389|NCT01807234|B2|Baseline|Ketorolac Then Placebo Then Sumatriptan|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.~Attack 2: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.~Attack 3: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril."
136403|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136390|NCT01807234|B1|Baseline|Ketorolac Then Sumatriptan Then Placebo|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.~Attack 2: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.~Attack 3: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril."
136391|NCT01807234|P6|Participant Flow|Placebo Then Sumatriptan Then Ketorolac|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.~Attack 2: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.~Attack 3: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril."
136392|NCT01807234|P5|Participant Flow|Placebo Then Ketorolac Then Sumatriptan|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.~Attack 2: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.~Attack 3: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril."
136393|NCT01807234|P4|Participant Flow|Sumatriptan Then Placebo Then Ketorolac|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.~Attack 2: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.~Attack 3: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril."
136394|NCT01807234|P3|Participant Flow|Sumatriptan Then Ketorolac Then Placebo|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.~Attack 2: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.~Attack 3: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril."
136395|NCT01807234|P2|Participant Flow|Kerorolac Then Placebo Then Sumatriptan|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.~Attack 2: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.~Attack 3: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril."
136396|NCT01807234|P1|Participant Flow|Ketorolac Then Sumatriptan Then Placebo|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.~Attack 2: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.~Attack 3: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril."
136397|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136398|NCT01807234|O2|Outcome|Sumatriptan/ Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo~Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136399|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo~Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136400|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136401|NCT01807234|O2|Outcome|Sumatriptan/ Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo~Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136492|NCT01806857|O2|Outcome|Matching Placebo|
136493|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
136404|NCT01807234|O2|Outcome|Sumatriptan/ Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo~Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136405|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo~Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136406|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136407|NCT01807234|O2|Outcome|Sumatriptan/ Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo~Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136408|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo~Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136409|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136410|NCT01807234|O2|Outcome|Sumatriptan/ Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo~Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136411|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo~Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136412|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136413|NCT01807234|O2|Outcome|Sumatriptan/ Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo~Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136414|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo~Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136415|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136416|NCT01807234|O2|Outcome|Sumatriptan/Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo~Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136417|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo~Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136418|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136419|NCT01807234|O2|Outcome|Sumatriptan/ Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo~Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136420|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo~Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136421|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136422|NCT01807234|O2|Outcome|Sumatriptan/Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo~Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136423|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo~Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136424|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136425|NCT01807234|O2|Outcome|Sumatriptan/ Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo~Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.~Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136426|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo~Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
136427|NCT01807234|E3|Reported Event|SRIX Placebo/Sumatriptan Placebo|"single dose SPRIX placebo, single dose Sumatriptan placebo~Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.~The most common adverse event for placebo were unusual taste (mild in 4%, moderate in 2%), nausea (4%), rash (4%), fatigue (4%), burning of the nose (2%), dizziness (2%)."
136428|NCT01807234|E2|Reported Event|Sumatriptan/Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo~Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.~Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.~For those treated with sumatriptan NS the most common adverse events were unusual taste (mild in 24.5%, moderate in 12.2%, severe 4.1%), burning of the nose (mild in 6.1%, moderate in 2%), nausea (8%), burning of the throat (6%), nasal discomfort (6%), dizziness (4%), fatigue (4%) and rash (2%)."
136429|NCT01807234|E1|Reported Event|Sprix/Placebo|"Sprix 31.5 mg single dose nasal spray and Placebo~SPRIX: Single dose of Sprix nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.~Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.~The most common adverse events reported by participants treated with ketorolac NS were burning of nose, (mild in 25.5%, moderate in 19.6% and severe in 3.9%), unusual taste (mild in 2%, moderate in 5.9%, severe 2%), nasal discomfort (8%), burning of throat (6%), fatigue (4%), dizziness (4%), nausea (2%), rash (2%)."
136430|NCT01807156|B1|Baseline|Tivozanib|"Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.~Tivozanib: Oral medication given daily. No placebo."
136431|NCT01807156|P1|Participant Flow|Tivozanib|"Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.~Tivozanib: Oral medication given daily. No placebo."
136432|NCT01807156|O1|Outcome|Tivozanib|"Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.~Tivozanib: Oral medication given daily. No placebo."
136433|NCT01807156|O1|Outcome|Tivozanib|"Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.~Tivozanib: Oral medication given daily. No placebo."
136434|NCT01807156|E1|Reported Event|Tivozanib|"Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.~Tivozanib: Oral medication given daily. No placebo."
136435|NCT01807000|B1|Baseline|[14C] PRUCALOPRIDE SUCCINATE|
136436|NCT01807000|P1|Participant Flow|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
136437|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
136438|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
136439|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
136440|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
136441|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
136442|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
136443|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
136444|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
136445|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
136446|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
136447|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
136448|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
136449|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
136450|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
136451|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
136452|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
136453|NCT01807000|E1|Reported Event|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
136454|NCT01806961|B1|Baseline|Clearance at End of Trial SP848-AK-1101|no trial medication during this follow-up trial
136455|NCT01806961|P1|Participant Flow|SP848-AK-1101|Patients from SP848-AK-1101 trial
136456|NCT01806961|O1|Outcome|Group 1|Patients from SP848-AK-1101 trial
136457|NCT01806961|E1|Reported Event|Group 1|Patients from SP848-AK-1101 trial
136458|NCT01806896|B3|Baseline|Total|Total of all reporting groups
136459|NCT01806896|B2|Baseline|Placebo Twice a Day|Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
136460|NCT01806896|B1|Baseline|PF-02545920 20 mg Twice a Day|Participants received PF-02545920 orally every 12 hours according to a titration dosing scheme: 5 mg twice daily (BID) on Days 1-2, 10 mg BID on Days 3-4, 15 mg BID on Days 5-6, and 20 mg BID on Days 7-28; followed by a 7 to 10 day safety evaluation period.
136461|NCT01806896|P2|Participant Flow|Placebo Twice a Day|Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
136462|NCT01806896|P1|Participant Flow|PF-02545920 20 mg Twice a Day|Participants received PF-02545920 orally every 12 hours according to a titration dosing scheme: 5 mg twice daily (BID) on Days 1-2, 10 mg BID on Days 3-4, 15 mg BID on Days 5-6, and 20 mg BID on Days 7-28; followed by a 7 to 10 day safety evaluation period.
136464|NCT01806896|O1|Outcome|PF-02545920 20 mg Twice a Day|Participants received PF-02545920 orally every 12 hours according to a titration dosing scheme: 5 mg twice daily (BID) on Days 1-2, 10 mg BID on Days 3-4, 15 mg BID on Days 5-6, and 20 mg BID on Days 7-28; followed by a 7 to 10 day safety evaluation period.
136465|NCT01806896|O2|Outcome|Placebo Twice a Day|Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
136466|NCT01806896|O1|Outcome|PF-02545920 20 mg Twice a Day|Participants received PF-02545920 orally every 12 hours according to a titration dosing scheme: 5 mg twice daily (BID) on Days 1-2, 10 mg BID on Days 3-4, 15 mg BID on Days 5-6, and 20 mg BID on Days 7-28; followed by a 7 to 10 day safety evaluation period.
136467|NCT01806896|O2|Outcome|Placebo Twice a Day|Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
136468|NCT01806896|O1|Outcome|PF-02545920 20 mg Twice a Day|Participants received PF-02545920 orally every 12 hours according to a titration dosing scheme: 5 mg twice daily (BID) on Days 1-2, 10 mg BID on Days 3-4, 15 mg BID on Days 5-6, and 20 mg BID on Days 7-28; followed by a 7 to 10 day safety evaluation period.
136469|NCT01806896|O2|Outcome|Placebo Twice a Day|Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
136470|NCT01806896|O1|Outcome|PF-02545920 20 mg Twice a Day|Participants received PF-02545920 orally every 12 hours according to a titration dosing scheme: 5 mg twice daily (BID) on Days 1-2, 10 mg BID on Days 3-4, 15 mg BID on Days 5-6, and 20 mg BID on Days 7-28; followed by a 7 to 10 day safety evaluation period.
136471|NCT01806896|O2|Outcome|Placebo Twice a Day|Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
136472|NCT01806896|O1|Outcome|PF-02545920 20 mg Twice a Day|Participants received PF-02545920 orally every 12 hours according to a titration dosing scheme: 5 mg twice daily (BID) on Days 1-2, 10 mg BID on Days 3-4, 15 mg BID on Days 5-6, and 20 mg BID on Days 7-28; followed by a 7 to 10 day safety evaluation period.
136473|NCT01806896|O2|Outcome|Placebo Twice a Day|Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
136474|NCT01806896|O1|Outcome|PF-02545920 20 mg Twice a Day|Participants received PF-02545920 orally every 12 hours according to a titration dosing scheme: 5 mg twice daily (BID) on Days 1-2, 10 mg BID on Days 3-4, 15 mg BID on Days 5-6, and 20 mg BID on Days 7-28; followed by a 7 to 10 day safety evaluation period.
136475|NCT01806896|O2|Outcome|Placebo Twice a Day|Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
136476|NCT01806896|O1|Outcome|PF-02545920 20 mg Twice a Day|Participants received PF-02545920 orally every 12 hours according to a titration dosing scheme: 5 mg twice daily (BID) on Days 1-2, 10 mg BID on Days 3-4, 15 mg BID on Days 5-6, and 20 mg BID on Days 7-28; followed by a 7 to 10 day safety evaluation period.
136477|NCT01806896|O2|Outcome|Placebo Twice a Day|Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
136478|NCT01806896|O1|Outcome|PF-02545920 20 mg Twice a Day|Participants received PF-02545920 orally every 12 hours according to a titration dosing scheme: 5 mg twice daily (BID) on Days 1-2, 10 mg BID on Days 3-4, 15 mg BID on Days 5-6, and 20 mg BID on Days 7-28; followed by a 7 to 10 day safety evaluation period.
136479|NCT01806896|O2|Outcome|Placebo Twice a Day|Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
136480|NCT01806896|O1|Outcome|PF-02545920 20 mg Twice a Day|Participants received PF-02545920 orally every 12 hours according to a titration dosing scheme: 5 mg twice daily (BID) on Days 1-2, 10 mg BID on Days 3-4, 15 mg BID on Days 5-6, and 20 mg BID on Days 7-28; followed by a 7 to 10 day safety evaluation period.
136481|NCT01806896|O2|Outcome|Placebo Twice a Day|Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
136482|NCT01806896|O1|Outcome|PF-02545920 20 mg Twice a Day|Participants received PF-02545920 orally every 12 hours according to a titration dosing scheme: 5 mg twice daily (BID) on Days 1-2, 10 mg BID on Days 3-4, 15 mg BID on Days 5-6, and 20 mg BID on Days 7-28; followed by a 7 to 10 day safety evaluation period.
136483|NCT01806896|O2|Outcome|Placebo Twice a Day|Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
136484|NCT01806896|O1|Outcome|PF-02545920 20 mg Twice a Day|Participants received PF-02545920 orally every 12 hours according to a titration dosing scheme: 5 mg twice daily (BID) on Days 1-2, 10 mg BID on Days 3-4, 15 mg BID on Days 5-6, and 20 mg BID on Days 7-28; followed by a 7 to 10 day safety evaluation period.
136485|NCT01806896|O2|Outcome|Placebo Twice a Day|Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
136486|NCT01806896|O1|Outcome|PF-02545920 20 mg Twice a Day|Participants received PF-02545920 orally every 12 hours according to a titration dosing scheme: 5 mg twice daily (BID) on Days 1-2, 10 mg BID on Days 3-4, 15 mg BID on Days 5-6, and 20 mg BID on Days 7-28; followed by a 7 to 10 day safety evaluation period.
136487|NCT01806896|E2|Reported Event|Placebo Twice a Day|Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
136488|NCT01806896|E1|Reported Event|PF-02545920 20 mg Twice a Day|Participants received PF-02545920 orally every 12 hours according to a titration dosing scheme: 5 mg twice daily (BID) on Days 1-2, 10 mg BID on Days 3-4, 15 mg BID on Days 5-6, and 20 mg BID on Days 7-28; followed by a 7 to 10 day safety evaluation period.
136489|NCT01806857|B1|Baseline|All Study Participants|
136490|NCT01806857|P2|Participant Flow|Matching Placebo Then Nuedexta|"Subjects in this arm will receive treatment with matching placebo first for 28 days (±3 days) and then crossed over to receive treatment with Nuedexta for 28 days (±3 days).~Nuedexta: Nuedexta PO (by mouth) for 28 ± 3 days~Matching Placebo: matching placebo PO (by mouth) for 28 ± 3 days"
136491|NCT01806857|P1|Participant Flow|Nuedexta Then Matching Placebo|"Subjects in this arm will receive treatment with Nuedexta first for 28 days (±3 days) and then crossed over to receive treatment with matching placebo for 28 days (±3 days).~Nuedexta: Nuedexta PO (by mouth) for 28 ± 3 days~Matching Placebo: matching placebo PO (by mouth) for 28 ± 3 days"
136527|NCT01806779|B2|Baseline|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.~Chantix~Zyban~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
136528|NCT01806779|B1|Baseline|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.~Chantix~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
136529|NCT01806779|P3|Participant Flow|Nicotine Patches Only|These subjects received nicotine patches at the first study visit but dropped out before randomization. 176 subjects attended the second study visit and provided side effects (SE) data. Two of these subjects dropped out during that visit (after providing SE data but prior to randomization). So, out of the initial 197 subjects receiving nicotine patches, 174 went on to receive Chantix or Chantix+Zyban; 23 subjects only received nicotine patches before dropping out.
136530|NCT01806779|P2|Participant Flow|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.~Chantix~Zyban~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
136531|NCT01806779|P1|Participant Flow|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.~Chantix~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
136532|NCT01806779|O2|Outcome|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.~Chantix~Zyban~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
136533|NCT01806779|O1|Outcome|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.~Chantix~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
136534|NCT01806779|O2|Outcome|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.~Chantix~Zyban~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
136535|NCT01806779|O1|Outcome|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.~Chantix~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
136536|NCT01806779|O2|Outcome|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.~Chantix~Zyban~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
136537|NCT01806779|O1|Outcome|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.~Chantix~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
136558|NCT01806662|P1|Participant Flow|Treatment Arm (Ustekinumab First, Then Palcebo)|"Since there is a crossover design, each patient will be in the treatment arm for 32 weeks (16 weeks on Ustekinumab, then 16 weeks on Placebo) of the study.~Ustekinumab: Injection of monoclonal antibody against the p40 subunit of IL-12/23"
136559|NCT01806662|O2|Outcome|Placebo Arm (Placebo First, Then Ustekinumab)|"Since there is a crossover design, each patient will be in the placebo arm for 16 weeks of the study. If a patient begins in the placebo arm, they will switch over to the treatment arm at week 16.~Placebo: Injection of placebo"
136538|NCT01806779|O2|Outcome|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.~Chantix~Zyban~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
136539|NCT01806779|O1|Outcome|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.~Chantix~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
136540|NCT01806779|E3|Reported Event|Nicotine Patch|All participants will receive Nicotine Replacement Therapy (NRT) in the form of 21 mg/24 h dose nicotine patches for 1 week prior to randomization to treatment with Chantix alone or Chantix + Zyban.
136541|NCT01806779|E2|Reported Event|Chantix + Zyban|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.~Chantix~Zyban~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
136542|NCT01806779|E1|Reported Event|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.~Chantix~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
136543|NCT01806714|B3|Baseline|Total|Total of all reporting groups
136544|NCT01806714|B2|Baseline|Control Arm|"Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)~Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)"
136545|NCT01806714|B1|Baseline|Text-based Reminder for HPV Vaccine/WCC|"Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit~Text-based reminder for recommended HPV vaccine or well care visit"
136546|NCT01806714|P2|Participant Flow|Control Arm|"Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)~Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)"
136547|NCT01806714|P1|Participant Flow|Text-based Reminder for HPV Vaccine/WCC|"Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit~Text-based reminder for recommended HPV vaccine or well care visit"
136548|NCT01806714|O2|Outcome|Control Arm|"Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)~Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)"
136549|NCT01806714|O1|Outcome|Text-based Reminder for HPV Vaccine/WCC|"Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit~Text-based reminder for recommended HPV vaccine or well care visit"
136550|NCT01806714|O2|Outcome|Control Arm|"Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)~Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)"
136551|NCT01806714|O1|Outcome|Text-based Reminder for HPV Vaccine/WCC|"Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit~Text-based reminder for recommended HPV vaccine or well care visit"
136552|NCT01806714|O2|Outcome|Control Arm|"Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)~Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)"
136553|NCT01806714|O1|Outcome|Text-based Reminder for HPV Vaccine/WCC|"Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit~Text-based reminder for recommended HPV vaccine or well care visit"
136554|NCT01806714|E2|Reported Event|Control Arm|"Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)~Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)"
136555|NCT01806714|E1|Reported Event|Text-based Reminder for HPV Vaccine/WCC|"Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit~Text-based reminder for recommended HPV vaccine or well care visit"
136556|NCT01806662|B1|Baseline|All Study Participants|"Since there is a crossover design, each participant will be in the Treatment Arm (Ustekinumab first, Then Placebo) or Placebo Arm (Placebo first, Then Ustekinumab) for 16 weeks of the study. They will crossover to the other treatment at week 16 for 16 weeks (32 weeks total).~Placebo: Injection of placebo Ustekinumab: Injection of monoclonal antibody against the p40 subunit of IL-12/23"
136557|NCT01806662|P2|Participant Flow|Placebo Arm (Placebo First, Then Ustekinumab)|"Since there is a crossover design, each patient will be in the placebo arm for 16 weeks of the study. If a patient begins in the placebo arm, they will switch over to the treatment arm at week 16 (for 16 weeks).~Placebo: Injection of placebo"
136560|NCT01806662|O1|Outcome|Treatment Arm (Ustekinumab First, Then Palcebo)|"Since there is a crossover design, each patient will be in the treatment arm for 16 weeks of the study.~Ustekinumab: Injection of monoclonal antibody against the p40 subunit of IL-12/23"
136561|NCT01806662|E2|Reported Event|Placebo|"Participants who received Placebo injection for 16 weeks.~Placebo: Injection of placebo"
136562|NCT01806662|E1|Reported Event|Ustekinumab|"Participants who received Ustekinumab injection for 16 weeks.~Ustekinumab: Injection of monoclonal antibody against the p40 subunit of IL-12/23"
136563|NCT01806623|B1|Baseline|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
136564|NCT01806623|P1|Participant Flow|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
136565|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
136566|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
136567|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
136568|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
136569|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
136570|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
136571|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
136572|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
136573|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
136574|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
136575|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
136576|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
136577|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
136578|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
136579|NCT01806623|E1|Reported Event|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
136580|NCT01806597|B4|Baseline|Total|Total of all reporting groups
136581|NCT01806597|B3|Baseline|Placebo|placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks.
136582|NCT01806597|B2|Baseline|AIN457 300 mg|AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks
136583|NCT01806597|B1|Baseline|AIN457 150mg|AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks
136584|NCT01806597|P6|Participant Flow|Any AIN457 Dose|All patients who were injected with AIN457
136585|NCT01806597|P5|Participant Flow|Placebo|placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks.
136586|NCT01806597|P4|Participant Flow|Placebo - AIN457 300mg|all placebo patients who were re-randomized to AIN457 300 mg at re-randomization
136587|NCT01806597|P3|Participant Flow|Placebo - AIN457 150 mg|all placebo patients who were re-randomized to secukinumab 150 mg at re-randomization
136588|NCT01806597|P2|Participant Flow|AIN457 300 mg|AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks
136589|NCT01806597|P1|Participant Flow|AIN457 150mg|AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks
136590|NCT01806597|O4|Outcome|Placebo - AIN457 300mg|all placebo patients who were re-randomized to AIN457 300 mg at re-randomization
136591|NCT01806597|O3|Outcome|Placebo - AIN 150mg|all placebo patients who were re-randomized to AIN457 150 mg at re-randomization
136592|NCT01806597|O2|Outcome|AIN457 300 mg|AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks
136593|NCT01806597|O1|Outcome|AIN457 150mg|AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks
136594|NCT01806597|O5|Outcome|Placebo|Placebo AIN457 (2sc injections) once weekly for 5 weeks followed by dosing every 4 weeks
136595|NCT01806597|O4|Outcome|Placebo - AIN457 300 mg|all placebo patients who were re-randomized to secukinumab 300 mg at re-randomization.
136596|NCT01806597|O3|Outcome|Placebo - AIN457 150 mg|all placebo patients who were re-randomized to secukinumab 150 mg at re-randomization.
136597|NCT01806597|O2|Outcome|AIN457 300 mg|AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks
136598|NCT01806597|O1|Outcome|AIN457 150mg|AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks
136599|NCT01806597|O3|Outcome|Placebo|placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks.
136600|NCT01806597|O2|Outcome|AIN457 300 mg|AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks
136601|NCT01806597|O1|Outcome|AIN457 150mg|AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks
136602|NCT01806597|O5|Outcome|Placebo|Placebo AIN457 (2sc injections) once weekly for 5 weeks followed by dosing every 4 weeks
136603|NCT01806597|O4|Outcome|Placebo - AIN457 300 mg|all placebo patients who were re-randomized to secukinumab 300 mg at re-randomization.
136604|NCT01806597|O3|Outcome|Placebo - AIN457 150 mg|all placebo patients who were re-randomized to secukinumab 150 mg at re-randomization.
136605|NCT01806597|O2|Outcome|AIN457 300 mg|AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks
157788|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter, 2010
136606|NCT01806597|O1|Outcome|AIN457 150mg|AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks
136607|NCT01806597|O5|Outcome|Placebo|Placebo AIN457 (2sc injections) once weekly for 5 weeks followed by dosing every 4 weeks
136608|NCT01806597|O4|Outcome|Placebo - AIN457 300 mg|all placebo patients who were re-randomized to secukinumab 300 mg at re-randomization.
136609|NCT01806597|O3|Outcome|Placebo - AIN457 150 mg|all placebo patients who were re-randomized to secukinumab 150 mg at re-randomization.
136610|NCT01806597|O2|Outcome|AIN457 300 mg|AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks
136611|NCT01806597|O1|Outcome|AIN457 150mg|AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks
136612|NCT01806597|O3|Outcome|Placebo|placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks.
136613|NCT01806597|O2|Outcome|AIN457 300 mg|AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks
136614|NCT01806597|O1|Outcome|AIN457 150mg|AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks
136615|NCT01806597|O3|Outcome|Placebo|placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks.
136616|NCT01806597|O2|Outcome|AIN457 300 mg|AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks
136617|NCT01806597|O1|Outcome|AIN457 150mg|AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks
136618|NCT01806597|E4|Reported Event|Any AIN457 Dose|All patients who were injected with AIN457
136619|NCT01806597|E3|Reported Event|Placebo|placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks.
136620|NCT01806597|E2|Reported Event|Any AIN457 300 mg|AIN457 300mg subcutaneous ((2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks
136621|NCT01806597|E1|Reported Event|Any AIN457 150 mg|AIN457 150mg subcutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks
136622|NCT01806584|B3|Baseline|Total|Total of all reporting groups
136623|NCT01806584|B2|Baseline|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.~After surgery, subjects were to undergo assessments during the 78-week follow-up period."
136624|NCT01806584|B1|Baseline|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
136625|NCT01806584|P2|Participant Flow|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.~After surgery, subjects were to undergo assessments during the 78-week follow-up period."
136626|NCT01806584|P1|Participant Flow|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
136627|NCT01806584|O2|Outcome|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.~After surgery, subjects were to undergo assessments during the 78-week follow-up period."
136628|NCT01806584|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
136629|NCT01806584|O2|Outcome|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.~After surgery, subjects were to undergo assessments during the 78-week follow-up period."
136630|NCT01806584|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
136631|NCT01806584|O2|Outcome|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.~After surgery, subjects were to undergo assessments during the 78-week follow-up period."
136632|NCT01806584|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
136633|NCT01806584|O2|Outcome|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.~After surgery, subjects were to undergo assessments during the 78-week follow-up period."
136634|NCT01806584|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
136635|NCT01806584|E2|Reported Event|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.~After surgery, subjects were to undergo assessments during the 78-week follow-up period."
136636|NCT01806584|E1|Reported Event|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
136637|NCT01806545|B3|Baseline|Total|Total of all reporting groups
136638|NCT01806545|B2|Baseline|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
136639|NCT01806545|B1|Baseline|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
136640|NCT01806545|P2|Participant Flow|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
136641|NCT01806545|P1|Participant Flow|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
136642|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
136643|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
136644|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
136645|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
136646|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
136647|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
136648|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
136649|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
136650|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
136651|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
136675|NCT01806389|E1|Reported Event|Buprenorphine|Buprenorphine maintained women at delivery of their infant
136676|NCT01806298|B1|Baseline|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
136831|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
136652|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
136653|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
136654|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
136655|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
136656|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
136657|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
136658|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
136659|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
136660|NCT01806545|E2|Reported Event|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
136661|NCT01806545|E1|Reported Event|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
136662|NCT01806389|B1|Baseline|Buprenorphine Maintained Lactating Women|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria
136663|NCT01806389|P1|Participant Flow|Buprenorphine Maintained Lactating Women|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria
136664|NCT01806389|O1|Outcome|INFANT PLASMA Buprenorphine Maintained Lactating Women Day 14|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing INFANT PLASMA for analysis on day 14
136665|NCT01806389|O5|Outcome|BREAST MILK Buprenorphine Maintained Lactating Women Day 30|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing BREAST MILK for analysis on day 30
136666|NCT01806389|O4|Outcome|BREAST MILK Buprenorphine Maintained Lactating Women Day 14|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing BREAST MILK for analysis on day 14
136667|NCT01806389|O3|Outcome|BREAST MILK Buprenorphine Maintained Lactating Women Day 4|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing BREAST MILK for analysis on day 4
136668|NCT01806389|O2|Outcome|BREAST MILK Buprenorphine Maintained Lactating Women Day 3|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing BREAST MILK for analysis on day 3
136669|NCT01806389|O1|Outcome|BREAST MILK Buprenorphine Maintained Lactating Women Day 2|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing breast milk for analysis on day 2
136670|NCT01806389|O5|Outcome|PLASMA Buprenorphine Maintained Lactating Women Day 30|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 30
136671|NCT01806389|O4|Outcome|PLASMA Buprenorphine Maintained Lactating Women Day 14|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 14
136672|NCT01806389|O3|Outcome|PLASMA Buprenorphine Maintained Lactating Women Day 4|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 4
136673|NCT01806389|O2|Outcome|PLASMA Buprenorphine Maintained Lactating Women Day 3|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 3
136674|NCT01806389|O1|Outcome|PLASMA Buprenorphine Maintained Lactating Women Day 2|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 2
136677|NCT01806298|P1|Participant Flow|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
136678|NCT01806298|O1|Outcome|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
136679|NCT01806298|O1|Outcome|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
136680|NCT01806298|O1|Outcome|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
136681|NCT01806298|O1|Outcome|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
136682|NCT01806298|O1|Outcome|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
136683|NCT01806298|O1|Outcome|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
136684|NCT01806298|O1|Outcome|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
136685|NCT01806298|E1|Reported Event|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
136686|NCT01806051|B1|Baseline|All Participants|
136687|NCT01806051|P1|Participant Flow|All Participants|Participants signed the consent forms and withdrew because they found the study procedures to be too cumbersome.
136688|NCT01806051|O2|Outcome|Control Group (Arm 2)|"Subjects allocated into this group will be healthy, non-PKU individuals that may be a relative (ex: sibling) of a PKU participant, but they don't have to be a blood relation.~These subjects will undergo a 24-Hour Blood Assessment (at Study Visit #2)."
136689|NCT01806051|O1|Outcome|PKU Participants (Arm 1)|"Subjects will be administered Kuvan once daily.~They will undergo several blood draws, including a 24-Hour Blood Assessment (at Study Visit #2 before the commencement of Kuvan), plasma Phe/Tyr draws (at Study Visits #3, 4, and 5), and another 24-Hour Blood Assessment (at Study Visit #6).~Kuvan: Only PKU participants (Arm 1) will be administered Kuvan once daily either at a dose of 20 mg/kg/day (if the PKU participant is not currently taking Kuvan) or at the subject's regular dose (if the PKU participant is currently taking Kuvan). They will remain on Kuvan for 4 weeks."
136690|NCT01806051|E2|Reported Event|Control Group (Arm 2)|"Subjects allocated into this group will be healthy, non-PKU individuals that may be a relative (ex: sibling) of a PKU participant, but they don't have to be a blood relation.~These subjects will undergo a 24-Hour Blood Assessment (at Study Visit #2)."
136691|NCT01806051|E1|Reported Event|PKU Participants (Arm 1)|"Subjects will be administered Kuvan once daily.~They will undergo several blood draws, including a 24-Hour Blood Assessment (at Study Visit #2 before the commencement of Kuvan), plasma Phe/Tyr draws (at Study Visits #3, 4, and 5), and another 24-Hour Blood Assessment (at Study Visit #6).~Kuvan: Only PKU participants (Arm 1) will be administered Kuvan once daily either at a dose of 20 mg/kg/day (if the PKU participant is not currently taking Kuvan) or at the subject's regular dose (if the PKU participant is currently taking Kuvan). They will remain on Kuvan for 4 weeks."
136692|NCT01805895|B3|Baseline|Total|Total of all reporting groups
136693|NCT01805895|B2|Baseline|Control|This arm will not receive any minocycline. This arm will receive standard of care treatment.
136694|NCT01805895|B1|Baseline|Minocycline|"This intervention arm will receive a total of 5 doses of Minocycline. Dose 1 of Minocycline will be 400mg IV within 12-hours of onset of symptoms. Dose 2 of Minocycline will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart.~Minocycline: This arm will receive a total of 5 doses of minocycline. Dose 1 will be 400mg IV within 12-hours of onset of symptoms. Dose 2 will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart."
136695|NCT01805895|P2|Participant Flow|Control|This arm will not receive any minocycline. This arm will receive standard of care treatment.
136696|NCT01805895|P1|Participant Flow|Minocycline|"This intervention arm will receive a total of 5 doses of Minocycline. Dose 1 of Minocycline will be 400mg IV within 12-hours of onset of symptoms. Dose 2 of Minocycline will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart.~Minocycline: This arm will receive a total of 5 doses of minocycline. Dose 1 will be 400mg IV within 12-hours of onset of symptoms. Dose 2 will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart."
136697|NCT01805895|O2|Outcome|Control|This arm will not receive any minocycline. This arm will receive standard of care treatment.
136698|NCT01805895|O1|Outcome|Minocycline|"This intervention arm will receive a total of 5 doses of Minocycline. Dose 1 of Minocycline will be 400mg IV within 12-hours of onset of symptoms. Dose 2 of Minocycline will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart.~Minocycline: This arm will receive a total of 5 doses of minocycline. Dose 1 will be 400mg IV within 12-hours of onset of symptoms. Dose 2 will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart."
136699|NCT01805895|O2|Outcome|Control|This arm will not receive any minocycline. This arm will receive standard of care treatment.
136700|NCT01805895|O1|Outcome|Minocycline|"This intervention arm will receive a total of 5 doses of Minocycline. Dose 1 of Minocycline will be 400mg IV within 12-hours of onset of symptoms. Dose 2 of Minocycline will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart.~Minocycline: This arm will receive a total of 5 doses of minocycline. Dose 1 will be 400mg IV within 12-hours of onset of symptoms. Dose 2 will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart."
136701|NCT01805895|E2|Reported Event|Control|This arm will not receive any minocycline. This arm will receive standard of care treatment.
136728|NCT01805882|O3|Outcome|C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
136870|NCT01804842|O3|Outcome|1000 mg Met DR qPM|"One dose of 1000 mg metformin delayed-release in the evening~Met DR: metformin delayed-release tablets"
136702|NCT01805895|E1|Reported Event|Minocycline|"This intervention arm will receive a total of 5 doses of Minocycline. Dose 1 of Minocycline will be 400mg IV within 12-hours of onset of symptoms. Dose 2 of Minocycline will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart.~Minocycline: This arm will receive a total of 5 doses of minocycline. Dose 1 will be 400mg IV within 12-hours of onset of symptoms. Dose 2 will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart."
136703|NCT01805882|B10|Baseline|Total|Total of all reporting groups
136704|NCT01805882|B9|Baseline|H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
136705|NCT01805882|B8|Baseline|G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
136706|NCT01805882|B7|Baseline|F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease
136707|NCT01805882|B6|Baseline|E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects
136708|NCT01805882|B5|Baseline|D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin
136709|NCT01805882|B4|Baseline|D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H
136710|NCT01805882|B3|Baseline|C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
136711|NCT01805882|B2|Baseline|B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
136712|NCT01805882|B1|Baseline|A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients
136713|NCT01805882|P9|Participant Flow|H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
136714|NCT01805882|P8|Participant Flow|G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
136715|NCT01805882|P7|Participant Flow|F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease
136716|NCT01805882|P6|Participant Flow|E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects
136717|NCT01805882|P5|Participant Flow|D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin
136718|NCT01805882|P4|Participant Flow|D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H
136719|NCT01805882|P3|Participant Flow|C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
136720|NCT01805882|P2|Participant Flow|B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
136721|NCT01805882|P1|Participant Flow|A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients
136722|NCT01805882|O9|Outcome|H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
136723|NCT01805882|O8|Outcome|G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
136724|NCT01805882|O7|Outcome|F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease
136725|NCT01805882|O6|Outcome|E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects
136726|NCT01805882|O5|Outcome|D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin
136727|NCT01805882|O4|Outcome|D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H
136729|NCT01805882|O2|Outcome|B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
136730|NCT01805882|O1|Outcome|A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients
136731|NCT01805882|E9|Reported Event|H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
136732|NCT01805882|E8|Reported Event|G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
136733|NCT01805882|E7|Reported Event|F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease
136734|NCT01805882|E6|Reported Event|E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects
136735|NCT01805882|E5|Reported Event|D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin
136736|NCT01805882|E4|Reported Event|D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H
136737|NCT01805882|E3|Reported Event|C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
136738|NCT01805882|E2|Reported Event|B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
136739|NCT01805882|E1|Reported Event|A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients
136740|NCT01805687|B1|Baseline|Zileuton Extended Release|Zileuton extended release
136741|NCT01805687|P1|Participant Flow|Zileuton Extended Release|Zileuton extended release 1200 mg (2 x 600 mg tablets)
136742|NCT01805687|O1|Outcome|Zileuton Extended Release|Zileuton extended release
136743|NCT01805687|E1|Reported Event|Zileuton Extended Release|Zileuton extended release
136744|NCT01805440|B4|Baseline|Total|Total of all reporting groups
136745|NCT01805440|B3|Baseline|Healthy Comparison|Subjects seen for screening and baseline scan. No randomization or treatment intervention for subjects enrolled as a Healthy Comparison.
136746|NCT01805440|B2|Baseline|Placebo|"Subjects randomized to this arm of the study will receive placebo 500 mg twice daily by mouth for 6 weeks.~Placebo: Pill placebo is the inactive treatment comparator in this clinical trial."
136747|NCT01805440|B1|Baseline|Uridine|"Subjects randomized to this study arm will receive uridine 500 mg twice daily by mouth for 6 weeks.~Uridine: Uridine is the active treatment in this clinical trial."
136748|NCT01805440|P3|Participant Flow|Healthy Comparison|Subjects seen for screening and baseline scan. No randomization or treatment intervention for subjects enrolled as a Healthy Comparison.
136749|NCT01805440|P2|Participant Flow|Placebo|"Subjects randomized to this arm of the study will receive placebo 500 mg twice daily by mouth for 6 weeks.~Placebo: Pill placebo is the inactive treatment comparator in this clinical trial."
136750|NCT01805440|P1|Participant Flow|Uridine|"Subjects randomized to this study arm will receive uridine 500 mg twice daily by mouth for 6 weeks.~Uridine: Uridine is the active treatment in this clinical trial."
136751|NCT01805440|O3|Outcome|Healthy Comparison|Subjects did not receive study medication. Subjects were only seen for baseline visit.
136752|NCT01805440|O2|Outcome|Placebo|"Subjects randomized to this arm of the study will receive placebo 500 mg twice daily by mouth for 6 weeks.~Placebo: Pill placebo is the inactive treatment comparator in this clinical trial."
136753|NCT01805440|O1|Outcome|Uridine|"Subjects randomized to this study arm will receive uridine 500 mg twice daily by mouth for 6 weeks.~Uridine: Uridine is the active treatment in this clinical trial."
136754|NCT01805440|O3|Outcome|Healthy Comparison|Subjects did not receive study medication. Subjects were only seen for baseline visit.
136755|NCT01805440|O2|Outcome|Placebo|"Subjects randomized to this arm of the study will receive placebo 500 mg twice daily by mouth for 6 weeks.~Placebo: Pill placebo is the inactive treatment comparator in this clinical trial."
136756|NCT01805440|O1|Outcome|Uridine|"Subjects randomized to this study arm will receive uridine 500 mg twice daily by mouth for 6 weeks.~Uridine: Uridine is the active treatment in this clinical trial."
136757|NCT01805440|O3|Outcome|Healthy Comparison|Subjects did not receive study medication. Subjects were only seen for baseline visit.
136758|NCT01805440|O2|Outcome|Placebo|"Subjects randomized to this arm of the study will receive placebo 500 mg twice daily by mouth for 6 weeks.~Placebo: Pill placebo is the inactive treatment comparator in this clinical trial."
136759|NCT01805440|O1|Outcome|Uridine|"Subjects randomized to this study arm will receive uridine 500 mg twice daily by mouth for 6 weeks.~Uridine: Uridine is the active treatment in this clinical trial."
136760|NCT01805440|E2|Reported Event|Placebo|"Subjects randomized to this arm of the study will receive placebo 500 mg twice daily by mouth for 6 weeks.~Placebo: Pill placebo is the inactive treatment comparator in this clinical trial."
136761|NCT01805440|E1|Reported Event|Uridine|"Subjects randomized to this study arm will receive uridine 500 mg twice daily by mouth for 6 weeks.~Uridine: Uridine is the active treatment in this clinical trial."
136762|NCT01805323|B1|Baseline|All Participants|Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
136763|NCT01805323|P1|Participant Flow|All Participants|Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
136764|NCT01805323|O1|Outcome|All Participants|Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
136765|NCT01805323|O1|Outcome|All Participants|Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
136766|NCT01805323|E1|Reported Event|All Participants|Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
136767|NCT01805297|B3|Baseline|Total|Total of all reporting groups
136768|NCT01805297|B2|Baseline|Standard Vitrectomy|"Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.~Standard Vitrectomy: Surgical intervention"
136769|NCT01805297|B1|Baseline|Vitrectomy With Aflibercept Injection|"Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.~Intravitreal Aflibercept Injection: One time 2.0mg aflibercept injection, immediately following pars plana vitrectomy."
136770|NCT01805297|P2|Participant Flow|Standard Vitrectomy|"Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.~Standard Vitrectomy: Surgical intervention"
136771|NCT01805297|P1|Participant Flow|Vitrectomy With Aflibercept Injection|"Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.~Intravitreal Aflibercept Injection: One time 2.0mg aflibercept injection, following pars plana vitrectomy."
136772|NCT01805297|O2|Outcome|Standard Vitrectomy|"Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.~Standard Vitrectomy: Surgical intervention"
136773|NCT01805297|O1|Outcome|Vitrectomy With Aflibercept Injection|"Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.~Intravitreal Aflibercept Injection: One time 2.0mg aflibercept injection, following pars plana vitrectomy."
136774|NCT01805297|O2|Outcome|Standard Vitrectomy|"Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.~Standard Vitrectomy: Surgical intervention"
136775|NCT01805297|O1|Outcome|Vitrectomy With Aflibercept Injection|"Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.~Intravitreal Aflibercept Injection: One time 2.0mg aflibercept injection, following pars plana vitrectomy."
136776|NCT01805297|O2|Outcome|Standard Vitrectomy|"Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.~Standard Vitrectomy: Surgical intervention"
136777|NCT01805297|O1|Outcome|Vitrectomy With Aflibercept Injection|"Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.~Intravitreal Aflibercept Injection: One time 2.0mg aflibercept injection, immediately following pars plana vitrectomy."
136778|NCT01805297|O2|Outcome|Standard Vitrectomy|"Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.~Standard Vitrectomy: Surgical intervention"
136779|NCT01805297|O1|Outcome|Vitrectomy With Aflibercept Injection|"Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.~Intravitreal Aflibercept Injection: One time 2.0mg aflibercept injection, following pars plana vitrectomy."
136780|NCT01805297|E2|Reported Event|Standard Vitrectomy|"Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.~Standard Vitrectomy: Surgical intervention"
136781|NCT01805297|E1|Reported Event|Vitrectomy With Aflibercept Injection|"Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.~Intravitreal Aflibercept Injection: One time 2.0mg aflibercept injection, following pars plana vitrectomy."
136782|NCT01805180|B3|Baseline|Total|Total of all reporting groups
136783|NCT01805180|B2|Baseline|Arm 2|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
136784|NCT01805180|B1|Baseline|Arm 1|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
136785|NCT01805180|P3|Participant Flow|Arm 2 - COBE Spectra Followed by Spectra Optia PMN|Healthy donors who were consented to participate in the pivotal trial and were randomized to receive the PMN collection procedure on the COBE Spectra first, followed by the Spectra Optia.
136786|NCT01805180|P2|Participant Flow|Arm 1 - Spectra Optia Followed by COBE Spectra PMN|Healthy donors who were consented to participate in the pivotal trial and were randomized to receive the PMN collection procedure on the Spectra Optia first, followed by the COBE Spectra.
136787|NCT01805180|P1|Participant Flow|Lead-in Donor|Subjects screened and enrolled for the purpose of training on the investigational procedure only. Included in safety analysis only.
136788|NCT01805180|O1|Outcome|Spectra Optia vs COBE Spectra|All 32 subjects received both the Spectra Optia and the COBE Spectra. RBC contamination results via hematocrit in collected product not reported by randomization treatment arms.
136789|NCT01805180|O1|Outcome|Spectra Optia vs COBE Spectra|All 32 subjects received both the Spectra Optia and the COBE Spectra. Device deficiency was not reported by randomization treatment arms.
136790|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
136791|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
136792|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
136793|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
136794|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
139818|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
136795|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
136796|NCT01805180|O1|Outcome|Spectra Optia vs COBE Spectra|All 32 subjects received both the Spectra Optia and the COBE Spectra. RBC contamination results via hematocrit in collected product not reported by randomization treatment arms.
136797|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
136798|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
136799|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
136800|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
136801|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
136802|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
136803|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
136804|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
136805|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
136806|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
136807|NCT01805180|E2|Reported Event|COBE Spectra|A total of n=42 subjects were randomized to receive a procedure. Randomized subjects are included in safety regardless if they withdrew or did not complete a procedure. Lead-in subjects are never exposed to COBE Spectra per protocol and not included. COBE Spectra events are AEs during the study period when the subject received the COBE Spectra.
136808|NCT01805180|E1|Reported Event|Spectra Optia|A total of n=48 subjects were either randomized to receive a procedure (n=42) or were assigned the Spectra Optia as a lead-in subject (lead-in n=6). Lead-in donors were not randomized and received the Spectra Optia only for training purposes and are included for Spectra Optia safety only. Randomized subjects are included in safety regardless if they withdrew or did not complete a procedure. Spectra Optia events are AEs during the study period when the subject received the Spectra Optia.
136809|NCT01805089|B3|Baseline|Total|Total of all reporting groups
136810|NCT01805089|B2|Baseline|Placebo|"Taken orally, once per day, at/around 9:00pm~Placebo"
136811|NCT01805089|B1|Baseline|Melatonin|"Taken orally, once per day, at/around 9:00pm~Melatonin"
136812|NCT01805089|P2|Participant Flow|Placebo|"Taken orally, once per day, at/around 9:00pm~Placebo"
136813|NCT01805089|P1|Participant Flow|Melatonin 3mg|"Taken orally, once per day, at/around 9:00pm~Melatonin"
136814|NCT01805089|O2|Outcome|Placebo|"Taken orally, once per day, at/around 9:00pm~Placebo"
136815|NCT01805089|O1|Outcome|Melatonin|"Taken orally, once per day, at/around 9:00pm~Melatonin"
136816|NCT01805089|O2|Outcome|Placebo|"Taken orally, once per day, at/around 9:00pm~Placebo"
136817|NCT01805089|O1|Outcome|Melatonin|"Taken orally, once per day, at/around 9:00pm~Melatonin"
136818|NCT01805089|O2|Outcome|Placebo|"Taken orally, once per day, at/around 9:00pm~Placebo"
136819|NCT01805089|O1|Outcome|Melatonin|"Taken orally, once per day, at/around 9:00pm~Melatonin"
136820|NCT01805089|E2|Reported Event|Placebo|"Taken orally, once per day, at/around 9:00pm~Placebo"
136821|NCT01805089|E1|Reported Event|Melatonin|"Taken orally, once per day, at/around 9:00pm~Melatonin"
136822|NCT01804946|B3|Baseline|Total|Total of all reporting groups
136823|NCT01804946|B2|Baseline|Oseltamivir Group (OG)|Oseltamivir(Tamiflu): Safety and Efficiency in treatment of Influenza
136824|NCT01804946|B1|Baseline|Ergoferon Group (EG)|"1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet TID.~Ergoferon: Safety and Efficiency of Ergoferon in treatment of Influenza"
136825|NCT01804946|P2|Participant Flow|Oseltamivir Group (OG)|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
136826|NCT01804946|P1|Participant Flow|Ergoferon Group (EG)|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
136827|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
136828|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
136829|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
136830|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
136832|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
136833|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
136834|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
136835|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
136836|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
136837|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
136838|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
136839|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
136840|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
136841|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
136842|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
136843|NCT01804946|O2|Outcome|Oseltamivir Goup (OG)|Oseltamivir(Tamiflu): Safety and Efficiency in treatment of Influenza
136844|NCT01804946|O1|Outcome|Ergoferon Group (EG)|"1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet TID.~Ergoferon: Safety and Efficiency of Ergoferon in treatment of Influenza"
136845|NCT01804946|E2|Reported Event|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
136846|NCT01804946|E1|Reported Event|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
136847|NCT01804881|B3|Baseline|Total|Total of all reporting groups
136848|NCT01804881|B2|Baseline|Wait List Control|wait list, offered program based on craving change(tm) material at end of study
136849|NCT01804881|B1|Baseline|Lifestyle Counseling|"Craving change group intervention for dietary counseling, 6 group sessions~Lifestyle counseling: Six week program to address problematic eating"
136850|NCT01804881|P2|Participant Flow|Wait List Control|wait list, offered program based on craving change(tm) material at end of study
136851|NCT01804881|P1|Participant Flow|Lifestyle Counseling|"Craving change group intervention for dietary counseling, 6 group sessions~Lifestyle counseling: Six week program to address problematic eating"
136852|NCT01804881|O2|Outcome|Wait List Control|wait list, offered group program at end of study
136853|NCT01804881|O1|Outcome|Lifestyle Counseling|"Group intervention for dietary counseling, 6 group sessions~Lifestyle counseling: Six week program to address problematic eating"
136854|NCT01804881|O2|Outcome|Wait List Control|wait list, offered group program at end of study
136855|NCT01804881|O1|Outcome|Lifestyle Counseling|"Group intervention for dietary counseling, 6 group sessions~Lifestyle counseling: Six week program to address problematic eating"
136856|NCT01804881|O2|Outcome|Wait List Control|wait list, offered craving change program at end of study
136857|NCT01804881|O1|Outcome|Lifestyle Counseling|"Craving change group intervention for dietary counseling, 6 group sessions~Lifestyle counseling: Six week program to address problematic eating"
136858|NCT01804881|E2|Reported Event|Wait List Control|wait list, offered craving change program at end of study
136859|NCT01804881|E1|Reported Event|Lifestyle Counseling|"Craving change group intervention for dietary counseling, 6 group sessions~Lifestyle counseling: Six week program to address problematic eating"
136860|NCT01804842|B4|Baseline|Total|Total of all reporting groups
136861|NCT01804842|B3|Baseline|Sequence 3: CAB|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
136862|NCT01804842|B2|Baseline|Sequence 2: BCA|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
136863|NCT01804842|B1|Baseline|Sequence 1: ABC|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
136864|NCT01804842|P3|Participant Flow|Sequence 3: CAB|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
136865|NCT01804842|P2|Participant Flow|Sequence 2: BCA|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
136866|NCT01804842|P1|Participant Flow|Sequence 1: ABC|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
136867|NCT01804842|O3|Outcome|1000 mg Met DR qPM|"One dose of 1000 mg metformin delayed-release in the evening~Met DR: metformin delayed-release tablets"
136868|NCT01804842|O2|Outcome|1000 mg Met DR qAM|"One dose of 1000 mg metformin delayed-release in the morning~Met DR: metformin delayed-release tablets"
136869|NCT01804842|O1|Outcome|500 mg Met DR BID|"Two doses of 500 mg metformin delayed-release~Met DR: metformin delayed-release tablets"
159502|NCT01712516|O4|Outcome|Placebo|b.i.d.
136871|NCT01804842|O2|Outcome|1000 mg Met DR qAM|"One dose of 1000 mg metformin delayed-release in the morning~Met DR: metformin delayed-release tablets"
136872|NCT01804842|O1|Outcome|500 mg Met DR BID|"Two doses of 500 mg metformin delayed-release~Met DR: metformin delayed-release tablets"
136873|NCT01804842|O3|Outcome|1000 mg Met DR qPM|"One dose of 1000 mg metformin delayed-release in the evening~Met DR: metformin delayed-release tablets"
136874|NCT01804842|O2|Outcome|1000 mg Met DR qAM|"One dose of 1000 mg metformin delayed-release in the morning~Met DR: metformin delayed-release tablets"
136875|NCT01804842|O1|Outcome|500 mg Met DR BID|"Two doses of 500 mg metformin delayed-release~Met DR: metformin delayed-release tablets"
136876|NCT01804842|O3|Outcome|1000 mg Met DR qPM|"One dose of 1000 mg metformin delayed-release in the evening~Met DR: metformin delayed-release tablets"
136877|NCT01804842|O2|Outcome|1000 mg Met DR qAM|"One dose of 1000 mg metformin delayed-release in the morning~Met DR: metformin delayed-release tablets"
136878|NCT01804842|O1|Outcome|500 mg Met DR BID|"Two doses of 500 mg metformin delayed-release~Met DR: metformin delayed-release tablets"
136879|NCT01804842|E3|Reported Event|500 mg Met DR BID|"Two doses of 500 mg metformin delayed-release~Met DR: metformin delayed-release tablets"
136880|NCT01804842|E2|Reported Event|1000 mg Met DR qPM|"One dose of 1000 mg metformin delayed-release in the evening~Met DR: metformin delayed-release tablets"
136881|NCT01804842|E1|Reported Event|1000 mg Met DR qAM|"One dose of 1000 mg metformin delayed-release in the morning~Met DR: metformin delayed-release tablets"
136882|NCT01804673|B1|Baseline|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
136883|NCT01804673|P1|Participant Flow|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
136884|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
136885|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
136886|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
136887|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
136888|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
136889|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
136890|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
136891|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
136892|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
136893|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
136894|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
136895|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
136896|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
136897|NCT01804673|E1|Reported Event|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
136898|NCT01804257|B1|Baseline|Digital Health Feedback System (DHFS)|"Ingestion Sensor, Wearable Sensor~Digital Health Feedback System: The digital health offering passively collects and records medication-taking behavior and other habits of daily living"
137108|NCT01802632|O1|Outcome|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) population. Dose groups were expanded to include more patients.
136899|NCT01804257|P1|Participant Flow|Digital Health Feedback System (DHFS)|"Ingestion Sensor, Wearable Sensor~Digital Health Feedback System: The digital health offering passively collects and records medication-taking behavior and other habits of daily living"
136900|NCT01804257|O1|Outcome|Digital Health Feedback System (DHFS)|Ingestion Sensor,...
136901|NCT01804257|E1|Reported Event|Digital Health Feedback System (DHFS)|DHFS
136902|NCT01804140|B1|Baseline|Participants With Confirmed Solid Tumors or Multiple Myeloma|Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
136903|NCT01804140|P1|Participant Flow|Participants With Confirmed Solid Tumors or Multiple Myeloma|Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
136904|NCT01804140|O1|Outcome|Participants With Confirmed Solid Tumors or Multiple Myeloma|Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
136905|NCT01804140|O1|Outcome|Participants With Confirmed Solid Tumors or Multiple Myeloma|Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
136906|NCT01804140|E1|Reported Event|Participants With Confirmed Solid Tumors or Multiple Myeloma|Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
136907|NCT01804101|B3|Baseline|Total|Total of all reporting groups
136908|NCT01804101|B2|Baseline|Arm II (Closed to Accrual Effective 4/21/14)|"INDUCTION/RE-INDUCTION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.~CONSOLIDATION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Liposomal Cytarabine-Daunorubicin CPX-351: Given IV"
136909|NCT01804101|B1|Baseline|Arm I (Lower-dose Liposomal Cytarabine-daunorubicin CPX-351)|"INDUCTION/RE-INDUCTION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.~CONSOLIDATION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Liposomal Cytarabine-Daunorubicin CPX-351: Given IV"
136910|NCT01804101|P2|Participant Flow|Arm II (Higher Dose COX-351)|"INDUCTION/RE-INDUCTION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.~CONSOLIDATION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Liposomal Cytarabine-Daunorubicin CPX-351: Given IV"
136911|NCT01804101|P1|Participant Flow|Arm I (Lower-dose CPX-351)|"INDUCTION/RE-INDUCTION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.~CONSOLIDATION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Liposomal Cytarabine-Daunorubicin CPX-351: Given IV"
136912|NCT01804101|O2|Outcome|Arm II (Higher Dose COX-351)|"INDUCTION/RE-INDUCTION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.~CONSOLIDATION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Liposomal Cytarabine-Daunorubicin CPX-351: Given IV"
136913|NCT01804101|O1|Outcome|Arm I (Lower-dose CPX-351)|"INDUCTION/RE-INDUCTION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.~CONSOLIDATION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Liposomal Cytarabine-Daunorubicin CPX-351: Given IV"
136936|NCT01804036|B1|Baseline|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem: Week 1: 10 mg Zolpidem daily for 1 week, Week 2: 10 mg Zolpidem daily for one week, taken as needed, Week 3: 5 mg Zolpidem daily for 1 week, taken as needed."
136937|NCT01804036|P2|Participant Flow|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
137526|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
136914|NCT01804101|O2|Outcome|Arm II (Closed to Accrual Effective 4/21/14)|"INDUCTION/RE-INDUCTION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.~CONSOLIDATION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Liposomal Cytarabine-Daunorubicin CPX-351: Given IV"
136915|NCT01804101|O1|Outcome|Arm I (Lower-dose Liposomal Cytarabine-daunorubicin CPX-351)|"INDUCTION/RE-INDUCTION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.~CONSOLIDATION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Liposomal Cytarabine-Daunorubicin CPX-351: Given IV"
136916|NCT01804101|E2|Reported Event|Arm II (Closed to Accrual Effective 4/21/14)|"INDUCTION/RE-INDUCTION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.~CONSOLIDATION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Liposomal Cytarabine-Daunorubicin CPX-351: Given IV"
136917|NCT01804101|E1|Reported Event|Arm I (Lower-dose Liposomal Cytarabine-daunorubicin CPX-351)|"INDUCTION/RE-INDUCTION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.~CONSOLIDATION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Liposomal Cytarabine-Daunorubicin CPX-351: Given IV"
136918|NCT01804075|B3|Baseline|Total|Total of all reporting groups
136919|NCT01804075|B2|Baseline|Methadone Treated|infants randomized to receive methadone as their primary treatment for withdrawal
136920|NCT01804075|B1|Baseline|Morphine Treated|infants randomized to receive morphine as their primary treatment for withdrawal
136921|NCT01804075|P2|Participant Flow|Morphine|"Morphine (1 mg/mL) administered orally every 4 hours. The following is a dosing guide:~NAS Score Morphine 8-12 0.05 mg/kg/dose >=13 0.1 mg/kg/dose~Maximum dose of morphine will be 0.2 mg/kg/dose. (NeoFax)~Additional doses, 0.05 mg/kg, may be given every 4 hours as needed and added to the next 24 hour's doses divided every 6 hours, until NAS scores are consistently <8 for 48 hours.~If the maximum dose of morphine is reached and if withdrawal is not controlled, the infant will be started on clonazepam (0.005 mg/kg/dose q 12h) per current treatment.~Methadone, Morphine: To compare the duration of opiate medication treatment for babies on methadone versus those on morphine."
136922|NCT01804075|P1|Participant Flow|Methadone|"Methadone (1 mg/mL) administered orally every 4 hours. The following is a dosing guide:~NAS Score Methadone 8-12 0.05 mg/kg/dose >=13 0.1 mg/kg/dose~Maximum dose of methadone will be 0.2 mg/kg/dose. (NeoFax)~Additional doses, 0.05 mg/kg, may be given every 4 hours as needed and added to the next 24 hour's doses divided every 4 hours, until NAS scores are consistently <8 for 48 hours.~If the maximum dose of methadone is reached and if withdrawal is not controlled, the infant will be started on clonazepam (0.005 mg/kg/dose q 12h) per current treatment.~Methadone, Morphine: To compare the duration of opiate medication treatment for babies on methadone versus those on morphine."
136923|NCT01804075|O2|Outcome|Morphine Treated|infants randomized to receive morphine as their primary treatment for withdrawal
136924|NCT01804075|O1|Outcome|Methadone Treated|infants randomized to receive methadone as their primary treatment for withdrawal
136925|NCT01804075|O2|Outcome|Morphine-treated|Group randomized to receive morphine treatment for their withdrawal
136926|NCT01804075|O1|Outcome|Methadone-treated|group of infants randomized to receive methadone treatment for their withdrawal
136927|NCT01804075|E2|Reported Event|Morphine|"Morphine (1 mg/mL) administered orally every 4 hours. The following is a dosing guide:~NAS Score Morphine 8-12 0.05 mg/kg/dose >=13 0.1 mg/kg/dose~Maximum dose of morphine will be 0.2 mg/kg/dose. (NeoFax)~Additional doses, 0.05 mg/kg, may be given every 4 hours as needed and added to the next 24 hour's doses divided every 6 hours, until NAS scores are consistently <8 for 48 hours.~If the maximum dose of morphine is reached and if withdrawal is not controlled, the infant will be started on clonazepam (0.005 mg/kg/dose q 12h) per current treatment.~Methadone, Morphine: To compare the duration of opiate medication treatment for babies on methadone versus those on morphine."
136928|NCT01804075|E1|Reported Event|Methadone|"Methadone (1 mg/mL) administered orally every 4 hours. The following is a dosing guide:~NAS Score Methadone 8-12 0.05 mg/kg/dose >=13 0.1 mg/kg/dose~Maximum dose of methadone will be 0.2 mg/kg/dose. (NeoFax)~Additional doses, 0.05 mg/kg, may be given every 4 hours as needed and added to the next 24 hour's doses divided every 4 hours, until NAS scores are consistently <8 for 48 hours.~If the maximum dose of methadone is reached and if withdrawal is not controlled, the infant will be started on clonazepam (0.005 mg/kg/dose q 12h) per current treatment.~Methadone, Morphine: To compare the duration of opiate medication treatment for babies on methadone versus those on morphine."
136929|NCT01804062|B1|Baseline|no Treatment|no treatment, prospective observational
136930|NCT01804062|P1|Participant Flow|no Treatment|no treatment, prospective observational
136931|NCT01804062|O1|Outcome|no Treatment|no treatment, prospective observational
136932|NCT01804062|O1|Outcome|no Treatment|no treatment, prospective observational
136933|NCT01804062|E1|Reported Event|no Treatment|no treatment, prospective observational
136934|NCT01804036|B3|Baseline|Total|Total of all reporting groups
136935|NCT01804036|B2|Baseline|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
139819|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
136938|NCT01804036|P1|Participant Flow|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem:~Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
136939|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
136940|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem: Week 1: 10 mg Zolpidem daily for 1 week, Week 2: 10 mg Zolpidem daily for one week, taken as needed, Week 3: 5 mg Zolpidem daily for 1 week, taken as needed."
136941|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
136942|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem: Week 1: 10 mg Zolpidem daily for 1 week, Week 2: 10 mg Zolpidem daily for one week, taken as needed, Week 3: 5 mg Zolpidem daily for 1 week, taken as needed."
136943|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
136944|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem: Week 1: 10 mg Zolpidem daily for 1 week, Week 2: 10 mg Zolpidem daily for one week, taken as needed, Week 3: 5 mg Zolpidem daily for 1 week, taken as needed."
136945|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
136946|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem:~Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
136947|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
136948|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem:~Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
136949|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
136950|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem:~Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
136951|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
136952|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem:~Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
136953|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
136954|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem:~Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
136955|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
136956|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem:~Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
136957|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
136958|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem:~Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
136959|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
136960|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem: Week 1: 10 mg Zolpidem daily for 1 week, Week 2: 10 mg Zolpidem daily for one week, taken as needed, Week 3: 5 mg Zolpidem daily for 1 week, taken as needed."
136961|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
136962|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem: Week 1: 10 mg Zolpidem daily for 1 week, Week 2: 10 mg Zolpidem daily for one week, taken as needed, Week 3: 5 mg Zolpidem daily for 1 week, taken as needed."
136963|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
139820|NCT01788163|O9|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
136964|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem:~Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
136965|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
136966|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem:~Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
136967|NCT01804036|E2|Reported Event|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
136968|NCT01804036|E1|Reported Event|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem:~Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
136969|NCT01803737|B3|Baseline|Total|Total of all reporting groups
136970|NCT01803737|B2|Baseline|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
136971|NCT01803737|B1|Baseline|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
136972|NCT01803737|P2|Participant Flow|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
136973|NCT01803737|P1|Participant Flow|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
136974|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
136975|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
136976|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
136977|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
136978|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
136979|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
136980|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
136981|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
136982|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
136983|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
136984|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
136985|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
136986|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
136987|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
136988|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
136989|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
136990|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
136991|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
136992|NCT01803737|E2|Reported Event|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
136993|NCT01803737|E1|Reported Event|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
136994|NCT01803711|B3|Baseline|Total|Total of all reporting groups
136995|NCT01803711|B2|Baseline|Desvenlafaxine + Placebo (for Omega 3 FA Supplement)|"Desvenlafaxine 50mg/day & Placebo (for Omega 3 FA supplement) over a 12 week period~Desvenlafaxine~Placebo (for Omega 3 fatty acid supplement) Age range: 53 to 66 years ] Gender: 1 male and 2 females"
136996|NCT01803711|B1|Baseline|Desvenlafaxine + Omega 3 FA Supplement|"Desvenlafaxine 50mg/day & Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period~Desvenlafaxine~Omega 3 Fatty acids~Age range: 53 to 66 years Gender: 1 male and 1 female"
136997|NCT01803711|P2|Participant Flow|Desvenlafaxine + Placebo (for Omega 3 FA Supplement)|"Desvenlafaxine 50mg/day & Placebo (for Omega 3 FA supplement) over a 12 week period~Desvenlafaxine~Placebo (for Omega 3 fatty acid supplement)~3 subjects were randomized to this group"
136998|NCT01803711|P1|Participant Flow|Desvenlafaxine + Omega 3 FA Supplement|"Desvenlafaxine 50mg/day & Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period~Desvenlafaxine~Omega 3 Fatty acids~2 subjects were randomized to this group"
136999|NCT01803711|O2|Outcome|Desvenlafaxine + Placebo (for Omega 3 FA Supplement)|"Desvenlafaxine 50mg/day & Placebo (for Omega 3 FA supplement) over a 12 week period~Desvenlafaxine~Placebo (for Omega 3 fatty acid supplement)~3 subjects were randomized to this group"
137000|NCT01803711|O1|Outcome|Desvenlafaxine + Omega 3 FA Supplement|"Desvenlafaxine 50mg/day & Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period~Desvenlafaxine~Omega 3 Fatty acids~2 subjects were randomized to this group"
137001|NCT01803711|O2|Outcome|Desvenlafaxine + Placebo (for Omega 3 FA Supplement)|"Desvenlafaxine 50mg/day & Placebo (for Omega 3 FA supplement) over a 12 week period~Desvenlafaxine~Placebo (for Omega 3 fatty acid supplement)~3 subjects were randomized to this group"
137002|NCT01803711|O1|Outcome|Desvenlafaxine + Omega 3 FA Supplement|"Desvenlafaxine 50mg/day & Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period~Desvenlafaxine~Omega 3 Fatty acids~2 subjects were randomized to this group"
137003|NCT01803711|O2|Outcome|Desvenlafaxine + Placebo (for Omega 3 FA Supplement)|"Desvenlafaxine 50mg/day & Placebo (for Omega 3 FA supplement) over a 12 week period~Desvenlafaxine~Placebo (for Omega 3 fatty acid supplement)~3 subjects were randomized to this group"
137004|NCT01803711|O1|Outcome|Desvenlafaxine + Omega 3 FA Supplement|"Desvenlafaxine 50mg/day & Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period~Desvenlafaxine~Omega 3 Fatty acids~2 subjects were randomized to this group"
137005|NCT01803711|O2|Outcome|Desvenlafaxine + Placebo (for Omega 3 FA Supplement)|"Desvenlafaxine 50mg/day & Placebo (for Omega 3 FA supplement) over a 12 week period~Desvenlafaxine~Placebo (for Omega 3 fatty acid supplement)~3 subjects were randomized to this group"
137006|NCT01803711|O1|Outcome|Desvenlafaxine + Omega 3 FA Supplement|"Desvenlafaxine 50mg/day & Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period~Desvenlafaxine~Omega 3 Fatty acids~2 subjects were randomized to this group"
137007|NCT01803711|O2|Outcome|Desvenlafaxine + Placebo (for Omega 3 FA Supplement)|"Desvenlafaxine 50mg/day & Placebo (for Omega 3 FA supplement) over a 12 week period~Desvenlafaxine~Placebo (for Omega 3 fatty acid supplement)~3 subjects were randomized to this group"
137008|NCT01803711|O1|Outcome|Desvenlafaxine + Omega 3 FA Supplement|"Desvenlafaxine 50mg/day & Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period~Desvenlafaxine~Omega 3 Fatty acids~2 subjects were randomized to this group"
137009|NCT01803711|O2|Outcome|Desvenlafaxine + Placebo (for Omega 3 FA Supplement)|"Desvenlafaxine 50mg/day & Placebo (for Omega 3 FA supplement) over a 12 week period~Desvenlafaxine~Placebo (for Omega 3 fatty acid supplement)"
137010|NCT01803711|O1|Outcome|Desvenlafaxine + Omega 3 FA Supplement|"Desvenlafaxine 50mg/day & Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period~Desvenlafaxine~Omega 3 Fatty acids"
137105|NCT01802632|P1|Participant Flow|AZD9291 80mg Extension|Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
137011|NCT01803711|E2|Reported Event|Desvenlafaxine + Placebo (for Omega 3 FA Supplement)|"Desvenlafaxine 50mg/day & Placebo (for Omega 3 FA supplement) over a 12 week period~Desvenlafaxine~Placebo (for Omega 3 fatty acid supplement)~3 subjects were randomized to this group"
137012|NCT01803711|E1|Reported Event|Desvenlafaxine + Omega 3 FA Supplement|"Desvenlafaxine 50mg/day & Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period~Desvenlafaxine~Omega 3 Fatty acids~2 subjects were randomized to this group"
137013|NCT01803646|B3|Baseline|Total|Total of all reporting groups
137014|NCT01803646|B2|Baseline|Placebo Gel|Three intratympanic administration of placebo gel within 5 days (D0-D4).
137015|NCT01803646|B1|Baseline|AM-101 0.87 mg/mL Gel|Three intratympanic administration of AM-101 0.87 mg/mL gel within 5 days (D0-D4)
137016|NCT01803646|P2|Participant Flow|Placebo Gel|Three intratympanic administration of placebo gel within 5 days (D0-D4).
137017|NCT01803646|P1|Participant Flow|AM-101 0.87 mg/mL Gel|Three intratympanic administration of AM-101 0.87 mg/mL gel within 5 days (D0-D4)
137018|NCT01803646|O2|Outcome|Placebo Gel|Three intratympanic administration of placebo gel within 5 days (D0-D4).
137019|NCT01803646|O1|Outcome|AM-101 0.87 mg/mL Gel|Three intratympanic administration of AM-101 0.87 mg/mL gel within 5 days (D0-D4)
137020|NCT01803646|O2|Outcome|Placebo Gel|Three intratympanic administration of placebo gel within 5 days (D0-D4).
137021|NCT01803646|O1|Outcome|AM-101 0.87 mg/mL Gel|Three intratympanic administration of AM-101 0.87 mg/mL gel within 5 days (D0-D4)
137022|NCT01803646|O2|Outcome|Placebo Gel|Three intratympanic administration of placebo gel within 5 days (D0-D4).
137023|NCT01803646|O1|Outcome|AM-101 0.87 mg/mL Gel|Three intratympanic administration of AM-101 0.87 mg/mL gel within 5 days (D0-D4)
137024|NCT01803646|E2|Reported Event|Placebo Gel|Three intratympanic administration of placebo gel within 5 days (D0-D4).
137025|NCT01803646|E1|Reported Event|AM-101 0.87 mg/mL Gel|Three intratympanic administration of AM-101 0.87 mg/mL gel within 5 days (D0-D4)
137026|NCT01803607|B3|Baseline|Total|Total of all reporting groups
137027|NCT01803607|B2|Baseline|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
137028|NCT01803607|B1|Baseline|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
137029|NCT01803607|P2|Participant Flow|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
137030|NCT01803607|P1|Participant Flow|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
137031|NCT01803607|O2|Outcome|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
137032|NCT01803607|O1|Outcome|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
137033|NCT01803607|O2|Outcome|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
137034|NCT01803607|O1|Outcome|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
137035|NCT01803607|O2|Outcome|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
137036|NCT01803607|O1|Outcome|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
137037|NCT01803607|O2|Outcome|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
137038|NCT01803607|O1|Outcome|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
137106|NCT01802632|O1|Outcome|80mg AZD9291 Extension|Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
159503|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
137039|NCT01803607|O2|Outcome|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
137040|NCT01803607|O1|Outcome|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
137041|NCT01803607|O2|Outcome|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
137042|NCT01803607|O1|Outcome|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
137043|NCT01803607|O2|Outcome|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
137044|NCT01803607|O1|Outcome|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
137045|NCT01803607|O2|Outcome|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
137046|NCT01803607|O1|Outcome|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
137047|NCT01803607|E2|Reported Event|Placebo OW|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium. One participant who was randomized to odanacatib 50 mg OW received placebo during the entire treatment period and was therefore included in the Placebo OW group for safety analyses.
137048|NCT01803607|E1|Reported Event|ODN 50 mg OW|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
137049|NCT01803464|B5|Baseline|Total|Total of all reporting groups
137050|NCT01803464|B4|Baseline|Typically Developing Control|Typically developing children without cerebral palsy will serve as controls.
137051|NCT01803464|B3|Baseline|Cerebral Palsy Control|Children with cerebral palsy who are recommended for but decline Botox treatment will serve as controls.
137052|NCT01803464|B2|Baseline|Botox|"Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to serve as a Botox-only group.~Botox: Children will not receive vibration treatment. Children in the Botox-only group will be offered vibration treatment at the end of the study."
137053|NCT01803464|B1|Baseline|Botox Plus Low-magnitude Vibration|"Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to also receive vibration treatment. Children will be asked to stand on a vibration plate 10 minutes per day for 6 months.~Botox plus low-magnitude vibration: Half of the children who receive Botox treatment will be randomly assigned to receive a high-frequency, low magnitude vibration treatment. The other half of the children who receive Botox treatment and are randomly assigned to the Botox-only group will be offered the vibration treatment at the end of the study."
137054|NCT01803464|P4|Participant Flow|Typically Developing Control|Typically developing children without cerebral palsy will serve as controls.
137055|NCT01803464|P3|Participant Flow|Cerebral Palsy Control|Children with cerebral palsy who are recommended for but decline Botox treatment will serve as controls.
137056|NCT01803464|P2|Participant Flow|Botox|"Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to serve as a Botox-only group.~Botox: Children will not receive vibration treatment. Children in the Botox-only group will be offered vibration treatment at the end of the study."
137057|NCT01803464|P1|Participant Flow|Botox Plus Low-magnitude Vibration|"Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to also receive vibration treatment. Children will be asked to stand on a vibration plate 10 minutes per day for 6 months.~Botox plus low-magnitude vibration: Half of the children who receive Botox treatment will be randomly assigned to receive a high-frequency, low magnitude vibration treatment. The other half of the children who receive Botox treatment and are randomly assigned to the Botox-only group will be offered the vibration treatment at the end of the study."
137058|NCT01803464|O4|Outcome|Typically Developing Control|Typically developing children without cerebral palsy will serve as controls
137059|NCT01803464|O3|Outcome|Cerebral Palsy Control|Cerebral palsy without treatment
137060|NCT01803464|O2|Outcome|Botox|"Cerebral palsy and Botox~Botox: Children who are candidates to receive Botox as part of their standard of care."
137107|NCT01802632|O1|Outcome|80mg AZD9291 Extension|Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
137061|NCT01803464|O1|Outcome|Botox Plus Low-magnitude Vibration|"Cerebral palsy and Botox plus vibration~Low-magnitude vibration: Children will receive a daily low-magnitude vibration treatment.~Botox: Children who are candidates to receive Botox as part of their standard of care."
137062|NCT01803464|O4|Outcome|Typically Developing Control|Typically developing children without cerebral palsy will serve as controls
137063|NCT01803464|O3|Outcome|Cerebral Palsy Control|Cerebral palsy without treatment
137064|NCT01803464|O2|Outcome|Botox|"Cerebral palsy and Botox~Botox: Children who are candidates to receive Botox as part of their standard of care."
137065|NCT01803464|O1|Outcome|Botox Plus Low-magnitude Vibration|"Cerebral palsy and Botox plus vibration~Low-magnitude vibration: Children will receive a daily low-magnitude vibration treatment.~Botox: Children who are candidates to receive Botox as part of their standard of care."
137066|NCT01803464|O4|Outcome|Typically Developing Control|Typically developing children without cerebral palsy will serve as controls.
137067|NCT01803464|O3|Outcome|Cerebral Palsy Control|Children with cerebral palsy who are recommended for but decline Botox treatment will serve as controls.
137068|NCT01803464|O2|Outcome|Botox|"Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to serve as a Botox-only group.~Botox: Children will not receive vibration treatment. Children in the Botox-only group will be offered vibration treatment at the end of the study."
137069|NCT01803464|O1|Outcome|Botox Plus Low-magnitude Vibration|"Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to also receive vibration treatment. Children will be asked to stand on a vibration plate 10 minutes per day for 6 months.~Botox plus low-magnitude vibration: Half of the children who receive Botox treatment will be randomly assigned to receive a high-frequency, low magnitude vibration treatment. The other half of the children who receive Botox treatment and are randomly assigned to the Botox-only group will be offered the vibration treatment at the end of the study."
137070|NCT01803464|E4|Reported Event|Typically Developing Control|Typically developing children without cerebral palsy will serve as controls.
137071|NCT01803464|E3|Reported Event|Cerebral Palsy Control|Children with cerebral palsy who are recommended for but decline Botox treatment will serve as controls.
137072|NCT01803464|E2|Reported Event|Botox|"Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to serve as a Botox-only group.~Botox: Children will not receive vibration treatment. Children in the Botox-only group will be offered vibration treatment at the end of the study."
137073|NCT01803464|E1|Reported Event|Botox Plus Low-magnitude Vibration|"Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to also receive vibration treatment. Children will be asked to stand on a vibration plate 10 minutes per day for 6 months.~Botox plus low-magnitude vibration: Half of the children who receive Botox treatment will be randomly assigned to receive a high-frequency, low magnitude vibration treatment. The other half of the children who receive Botox treatment and are randomly assigned to the Botox-only group will be offered the vibration treatment at the end of the study."
137074|NCT01802775|B3|Baseline|Total|Total of all reporting groups
137075|NCT01802775|B2|Baseline|Edoxaban|Open-label edoxaban with aspirin
137076|NCT01802775|B1|Baseline|Clopidogrel|Open-label clopidogrel with aspirin
137077|NCT01802775|P2|Participant Flow|Edoxaban|Open-label edoxaban with aspirin
137078|NCT01802775|P1|Participant Flow|Clopidogrel|Open-label clopidogrel with aspirin
137079|NCT01802775|O2|Outcome|Edoxaban|Open-label edoxaban with aspirin
137080|NCT01802775|O1|Outcome|Clopidogrel|Open-label clopidogrel with aspirin
137081|NCT01802775|O2|Outcome|Edoxaban|Open-label edoxaban with aspirin
137082|NCT01802775|O1|Outcome|Clopidogrel|Open-label clopidogrel with aspirin
137083|NCT01802775|O2|Outcome|Edoxaban|Open-label edoxaban with aspirin
137084|NCT01802775|O1|Outcome|Clopidogrel|Open-label clopidogrel with aspirin
137085|NCT01802775|O2|Outcome|Edoxaban|Open-label edoxaban with aspirin
137086|NCT01802775|O1|Outcome|Clopidogrel|Open-label clopidogrel with aspirin
137087|NCT01802775|O2|Outcome|Edoxaban|Open-label edoxaban with aspirin
137088|NCT01802775|O1|Outcome|Clopidogrel|Open-label clopidogrel with aspirin
137089|NCT01802775|O2|Outcome|Edoxaban|Open-label edoxaban with aspirin
137090|NCT01802775|O1|Outcome|Clopidogrel|Open-label clopidogrel with aspirin
137091|NCT01802775|E2|Reported Event|Edoxaban|Open-label edoxaban with aspirin
137092|NCT01802775|E1|Reported Event|Clopidogrel|Open-label clopidogrel with aspirin
137093|NCT01802632|B7|Baseline|Total|Total of all reporting groups
137094|NCT01802632|B6|Baseline|Japan Cytology|Japan-only cohort of patients (EGFR T790M mutation status determined from cytology samples) receiving AZD9291 80 mg tablet.
137095|NCT01802632|B5|Baseline|80mg Tablet|US-only cohort of pre-treated EGFR patients receiving the tablet formulation of AZD9291 (80 mg).
137096|NCT01802632|B4|Baseline|First Line|Cohort of patients receiving first-line treatment for EGFRm advanced NSCLC, in 80mg and 160mg AZD9291 capsule.
137097|NCT01802632|B3|Baseline|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
137098|NCT01802632|B2|Baseline|Dose Escalation|Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
137099|NCT01802632|B1|Baseline|AZD9291 80mg Extension|Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
137100|NCT01802632|P6|Participant Flow|Japan Cytology|Japan-only cohort of patients (EGFR T790M mutation status determined from cytology samples) receiving AZD9291 80 mg tablet.
137101|NCT01802632|P5|Participant Flow|80mg Tablet|US-only cohort of pre-treated EGFR patients receiving the tablet formulation of AZD9291 (80 mg).
137102|NCT01802632|P4|Participant Flow|First Line|Cohort of patients receiving first-line treatment for EGFRm advanced NSCLC, in 80mg and 160mg AZD9291 capsule.
137103|NCT01802632|P3|Participant Flow|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
137104|NCT01802632|P2|Participant Flow|Dose Escalation|Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
159504|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
137109|NCT01802632|O1|Outcome|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) population. Dose groups were expanded to include more patients.
137110|NCT01802632|O1|Outcome|Dose Escalation|Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
137111|NCT01802632|O1|Outcome|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
137112|NCT01802632|E6|Reported Event|Japan Cytology|Japan-only cohort of patients (EGFR T790M mutation status determined from cytology samples) receiving AZD9291 80 mg tablet.
137113|NCT01802632|E5|Reported Event|80mg Tablet|US-only cohort of pre-treated EGFR patients receiving the tablet formulation of AZD9291 (80 mg).
137114|NCT01802632|E4|Reported Event|First Line|Cohort of patients receiving first-line treatment for EGFRm advanced NSCLC, in 80mg and 160mg AZD9291 capsule.
137115|NCT01802632|E3|Reported Event|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
137116|NCT01802632|E2|Reported Event|Dose Escalation|Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
137117|NCT01802632|E1|Reported Event|AZD9291 80mg Extension|Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
137118|NCT01802554|B3|Baseline|Total|Total of all reporting groups
137119|NCT01802554|B2|Baseline|Information Support (IS)|Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers' needs. When requested by the caregiver, supportive psychotherapy was also provided.
137120|NCT01802554|B1|Baseline|Pleasant Events Program (PEP)|The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.
137121|NCT01802554|P2|Participant Flow|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.~Pleasant Events Program (PEP) : Behavioral Activation Therapy"
137122|NCT01802554|P1|Participant Flow|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers' needs. When requested by the caregiver, supportive psychotherapy was also provided.~Information Support (IS) : Supportive Psychotherapy and informational brochures"
137123|NCT01802554|O2|Outcome|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers’ needs. When requested by the caregiver, supportive psychotherapy was also provided.~Information Support (IS): Supportive Psychotherapy and informational brochures"
137124|NCT01802554|O1|Outcome|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.~Pleasant Events Program (PEP): Behavioral Activation Therapy"
137125|NCT01802554|O2|Outcome|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers’ needs. When requested by the caregiver, supportive psychotherapy was also provided.~Information Support (IS): Supportive Psychotherapy and informational brochures"
137126|NCT01802554|O1|Outcome|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.~Pleasant Events Program (PEP): Behavioral Activation Therapy"
137141|NCT01802515|P1|Participant Flow|Atomoxetine, Low Dose|"1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.~Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose."
162175|NCT01704404|O6|Outcome|Dose 6 TD-4208|"700 µg~TD-4208"
137127|NCT01802554|O2|Outcome|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers’ needs. When requested by the caregiver, supportive psychotherapy was also provided.~Information Support (IS): Supportive Psychotherapy and informational brochures"
137128|NCT01802554|O1|Outcome|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.~Pleasant Events Program (PEP): Behavioral Activation Therapy"
137129|NCT01802554|O2|Outcome|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers’ needs. When requested by the caregiver, supportive psychotherapy was also provided.~Information Support (IS): Supportive Psychotherapy and informational brochures"
137130|NCT01802554|O1|Outcome|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.~Pleasant Events Program (PEP): Behavioral Activation Therapy"
137131|NCT01802554|O2|Outcome|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers’ needs. When requested by the caregiver, supportive psychotherapy was also provided.~Information Support (IS): Supportive Psychotherapy and informational brochures"
137132|NCT01802554|O1|Outcome|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.~Pleasant Events Program (PEP): Behavioral Activation Therapy"
137133|NCT01802554|E2|Reported Event|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers’ needs. When requested by the caregiver, supportive psychotherapy was also provided.~Information Support (IS): Supportive Psychotherapy and informational brochures"
137134|NCT01802554|E1|Reported Event|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.~Pleasant Events Program (PEP): Behavioral Activation Therapy"
137135|NCT01802515|B4|Baseline|Total|Total of all reporting groups
137136|NCT01802515|B3|Baseline|Placebo (Sugar Pill)|"1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.~Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose."
137137|NCT01802515|B2|Baseline|Atomoxetine, High Dose|"One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules~Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose."
137138|NCT01802515|B1|Baseline|Atomoxetine, Low Dose|"1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.~Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose."
137139|NCT01802515|P3|Participant Flow|Placebo (Sugar Pill)|"1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.~Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose."
137140|NCT01802515|P2|Participant Flow|Atomoxetine, High Dose|"One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules~Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose."
137170|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137142|NCT01802515|O3|Outcome|Placebo (Sugar Pill)|"1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.~Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose."
137143|NCT01802515|O2|Outcome|Atomoxetine, High Dose|"One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules~Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose."
137144|NCT01802515|O1|Outcome|Atomoxetine, Low Dose|"1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.~Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose."
137145|NCT01802515|O3|Outcome|Placebo (Sugar Pill)|"1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.~Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose."
137146|NCT01802515|O2|Outcome|Atomoxetine, High Dose|"One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules~Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose."
137147|NCT01802515|O1|Outcome|Atomoxetine, Low Dose|"1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.~Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose."
137148|NCT01802515|E3|Reported Event|Placebo (Sugar Pill)|"1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.~Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose."
137149|NCT01802515|E2|Reported Event|Atomoxetine, High Dose|"One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules~Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose."
137150|NCT01802515|E1|Reported Event|Atomoxetine, Low Dose|"1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.~Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose."
137151|NCT01802320|B1|Baseline|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 orally on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
137152|NCT01802320|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 orally on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
137153|NCT01802320|O1|Outcome|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 orally on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
137154|NCT01802320|O1|Outcome|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 orally on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
137155|NCT01802320|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 orally on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
137156|NCT01802151|B5|Baseline|Total|Total of all reporting groups
137157|NCT01802151|B4|Baseline|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137158|NCT01802151|B3|Baseline|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137159|NCT01802151|B2|Baseline|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137160|NCT01802151|B1|Baseline|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
137161|NCT01802151|P4|Participant Flow|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137162|NCT01802151|P3|Participant Flow|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137163|NCT01802151|P2|Participant Flow|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137164|NCT01802151|P1|Participant Flow|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
137165|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137166|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137167|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137168|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
137169|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
162176|NCT01704404|O5|Outcome|Dose 5 TD-4208|"350 µg~TD-4208"
137171|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137172|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
137173|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137174|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137175|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137176|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
137177|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137178|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137179|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137180|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
137181|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137182|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137183|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137184|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
137185|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137186|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137187|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137188|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
137189|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137190|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137191|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137192|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
137193|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137194|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137195|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137196|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
137197|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137198|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137199|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137200|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
137201|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137202|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137203|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137204|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
137205|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137206|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137207|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137208|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
137209|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137210|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137211|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137212|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
137213|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137214|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137215|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137216|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
137217|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137218|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137219|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137220|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
137221|NCT01802151|E4|Reported Event|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137222|NCT01802151|E3|Reported Event|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137223|NCT01802151|E2|Reported Event|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
137224|NCT01802151|E1|Reported Event|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
137225|NCT01801982|B1|Baseline|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
137226|NCT01801982|P1|Participant Flow|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
137227|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
137228|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
137229|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
137230|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
137231|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
137232|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
137233|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
137524|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
137234|NCT01801982|E1|Reported Event|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
137235|NCT01801917|B5|Baseline|Total|Total of all reporting groups
137236|NCT01801917|B4|Baseline|Placebo/BAF312 10 mg|Patients on placebo in Period 1 switch to active 10 mg BAF312 in Period 2
137237|NCT01801917|B3|Baseline|Placebo/BAF312 2 mg|Patients on placebo in Period 1 switch to active 2 mg BAF312 in Period 2
137238|NCT01801917|B2|Baseline|BAF312 10 mg/BAF312 10 mg|Patients in Period 1 continue on same 10 mg dose of BAF312 in Period 2
137239|NCT01801917|B1|Baseline|BAF312 2mg/BAF312 2mg|Patients in Period 1 continue on same 2 mg dose of BAF312 in Period 2
137240|NCT01801917|P4|Participant Flow|Placebo/BAF312 10 mg|Patients on placebo in Period 1 switch to active 10 mg BAF312 in Period 2
137241|NCT01801917|P3|Participant Flow|Placebo/BAF312 2 mg|Patients on placebo in Period 1 switch to active 2 mg BAF312 in Period 2
137242|NCT01801917|P2|Participant Flow|BAF312 10 mg/BAF312 10 mg|Patients in Period 1 continue on same 10 mg dose of BAF312 in Period 2
137243|NCT01801917|P1|Participant Flow|BAF312 2mg/BAF312 2mg|Patients in Period 1 continue on same 2 mg dose of BAF312 in Period 2
137244|NCT01801917|O2|Outcome|BAF312 10 mg|5 tablets of BAF312 2 mg daily during Period 1
137245|NCT01801917|O1|Outcome|BAF312 2mg|1 tablet of BAF312 2 mg + 4 tablets of Placebo daily during Period 1
137246|NCT01801917|O2|Outcome|Placebo/BAF312 2 mg|Patients on placebo in Period 1 switch to active 2 mg BAF312 in Period 2
137247|NCT01801917|O1|Outcome|BAF312 2mg|1 tablet of BAF312 2 mg + 4 tablets of Placebo daily during Period 1
137248|NCT01801917|O3|Outcome|Placebo|matching placebo
137249|NCT01801917|O2|Outcome|BAF312 10 mg|5 tablets of BAF312 2 mg daily during Period 1
137250|NCT01801917|O1|Outcome|BAF312 2mg|1 tablet of BAF312 2 mg + 4 tablets of Placebo daily during Period 1
137251|NCT01801917|O3|Outcome|Placebo|matching placebo
137252|NCT01801917|O2|Outcome|BAF312 10 mg|5 tablets of BAF312 2 mg daily during Period 1
137253|NCT01801917|O1|Outcome|BAF312 2mg|1 tablet of BAF312 2 mg + 4 tablets of Placebo daily during Period 1
137254|NCT01801917|O3|Outcome|Placebo|matching placebo
137255|NCT01801917|O2|Outcome|BAF312 10 mg|5 tablets of BAF312 2 mg daily during Period 1
137256|NCT01801917|O1|Outcome|BAF312 2mg|1 tablet of BAF312 2 mg + 4 tablets of Placebo daily during Period 1
137257|NCT01801917|E5|Reported Event|Period 2 Placebo/ BAF312 2mg|Period 2 Placebo/ BAF312 2mg
137258|NCT01801917|E4|Reported Event|Period 2 BAF312 2mg/ BAF312 2mg|Period 2 BAF312 2mg/ BAF312 2mg
137259|NCT01801917|E3|Reported Event|Period 1 Placebo|Period 1 Placebo
137260|NCT01801917|E2|Reported Event|Period 1 BAF312 10mg|Period 1 BAF312 10mg
137261|NCT01801917|E1|Reported Event|Period 1 BAF312 2mg|Period 1 BAF312 2mg
137262|NCT01801735|B1|Baseline|Meloxicam 10 mg|Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
137263|NCT01801735|P1|Participant Flow|Meloxicam 10 mg|Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
137264|NCT01801735|O1|Outcome|Meloxicam 10 mg|Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
137265|NCT01801735|E1|Reported Event|Meloxicam 10 mg|Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
137266|NCT01801475|B4|Baseline|Total|Total of all reporting groups
137267|NCT01801475|B3|Baseline|Neonates|"Babies of the pregnant women enrolled in the study; no ondansetron is given to babies in this Aim 1 of the study. Babies of pregnant women are not given Ondansetron but are in the study for 24-48 hours."
137268|NCT01801475|B2|Baseline|Non-pregnant Women|"Non-pregnant women scheduled for surgery at Stanford who will be given Ondansetron prior to their surgery as standard-of-care.~Ondansetron: non-pregnant women will receive either 4mg or 8mg of Ondansetron (IV) once prior to surgical procedure (open-label). Women are in the study for 8 hours."
137269|NCT01801475|B1|Baseline|Pregnant Women|"Full term pregnant women scheduled for Cesarean section and will be given Ondansetron as standard-of-care prior to surgery.~Ondansetron: Pregnant women will receive either 4mg or 8mg of Ondansetron (IV) once prior to surgical procedure (open-label). Women are in the study for 8 hours."
137270|NCT01801475|P5|Participant Flow|Neonates|The neonates became part of the subject population after birth. They were subsequently sampled for pharmacokinetic samples.
137271|NCT01801475|P4|Participant Flow|Non-pregnant Women - 4 mg Ondansetron|As a comparison for pharmacokinetics, a non-pregnant group was enrolled and received ondansetron. 4 mg ondansetron
137272|NCT01801475|P3|Participant Flow|Non-pregnant Women - 8 mg Ondansetron|As a comparison for pharmacokinetics, a non-pregnant group was enrolled and received ondansetron. 8 mg ondansetron
137273|NCT01801475|P2|Participant Flow|Ondansetron 8 mg IV - Pregnant|Ondansetron 8 mg was given intravenously prior to delivery of the infant.
137274|NCT01801475|P1|Participant Flow|Ondansetron 4 mg IV - Pregnant|Ondansetron 4 mg was given intravenously prior to delivery of the infant.
137275|NCT01801475|O2|Outcome|Neonates|The neonates became part of the subject population after birth. They were subsequently sampled for pharmacokinetic samples.
137276|NCT01801475|O1|Outcome|Women - Pregnant/Non-pregnant|Ondansetron 4 mg or 8mg was given intravenously prior to delivery of her baby in pregnant women and was given to age similar women in the non-pregnant group.
137277|NCT01801475|O2|Outcome|Neonates|The neonates became part of the subject population after birth. They were subsequently sampled for pharmacokinetic samples.
137278|NCT01801475|O1|Outcome|Women - Pregnant/Non-pregnant|Ondansetron 4 mg or 8mg was given intravenously prior to delivery of her baby in pregnant women and was given to age similar women in the non-pregnant group.
137279|NCT01801475|E5|Reported Event|Neonates|The neonates became part of the subject population after birth. They were subsequently sampled for pharmacokinetic samples.
137280|NCT01801475|E4|Reported Event|Non-pregnant Women - 4 mg Ondansetron|As a comparison for pharmacokinetics, a non-pregnant group was enrolled and received ondansetron. 4 mg ondansetron
137281|NCT01801475|E3|Reported Event|Non-pregnant Women - 8 mg Ondansetron|As a comparison for pharmacokinetics, a non-pregnant group was enrolled and received ondansetron. 8 mg ondansetron
137282|NCT01801475|E2|Reported Event|Ondansetron 8 mg IV - Pregnant|Ondansetron 8 mg was given intravenously prior to delivery of the infant.
137283|NCT01801475|E1|Reported Event|Ondansetron 4 mg IV - Pregnant|Ondansetron 4 mg was given intravenously prior to delivery of the infant.
137284|NCT01801449|B1|Baseline|Rilonacept Treatment|Rilonacept loading dose of 4.4 mg/kg/week followed by maintenace dose of 2.2 mg/kg/week. Total duration of the study 24 months.
137285|NCT01801449|P1|Participant Flow|Rilonacept Treatment|Rilonacept loading dose of 4.4 mg/kg/week followed by maintenace dose of 2.2 mg/kg/week.Total duration of the study 24 months.
137286|NCT01801449|O1|Outcome|Rilonacept Treatment|Rilonacept loading dose of 4.4 mg/kg/week followed by maintenace dose of 2.2 mg/kg/week.Total duration of the study 24 months.
137287|NCT01801449|O1|Outcome|Rilonacept Treatment|Rilonacept loading dose of 4.4 mg/kg/week followed by maintenace dose of 2.2 mg/kg/week. Total duration of the study 24 months.
137288|NCT01801449|O1|Outcome|Rilonacept Treatment|Rilonacept loading dose of 4.4 mg/kg/week followed by maintenace dose of 2.2 mg/kg/week. Total duration of the study 24 months.
137289|NCT01801449|O1|Outcome|Rilonacept Treatment|Rilonacept loading dose of 4.4 mg/kg/week followed by maintenace dose of 2.2 mg/kg/week. Total duration of the study 24 months.
137290|NCT01801449|O1|Outcome|Rilonacept Treatment|Rilonacept loading dose of 4.4 mg/kg/week followed by maintenace dose of 2.2 mg/kg/week. Total duration of the study 24 months.
137291|NCT01801449|O1|Outcome|Rilonacept Treatment|Rilonacept loading dose of 4.4 mg/kg/week followed by maintenace dose of 2.2 mg/kg/week. Total duration of the study 24 months.
137292|NCT01801449|O1|Outcome|Rilonacept Treatment|Rilonacept loading dose of 4.4 mg/kg/week followed by maintenace dose of 2.2 mg/kg/week. Total duration of the study 24 months.
137293|NCT01801449|O1|Outcome|Rilonacept Treatment|Rilonacept loading dose of 4.4 mg/kg/week followed by maintenace dose of 2.2 mg/kg/week. Total duration of the study 24 months.
137294|NCT01801449|O1|Outcome|Rilonacept Treatment|Rilonacept loading dose of 4.4 mg/kg/week followed by maintenace dose of 2.2 mg/kg/week. Total duration of the study 24 months.
137295|NCT01801449|O1|Outcome|Rilonacept Treatment|Rilonacept loading dose of 4.4 mg/kg/week followed by maintenace dose of 2.2 mg/kg/week. Total duration of the study 24 months.
137296|NCT01801449|O1|Outcome|Rilonacept Treatment|Rilonacept loading dose of 4.4 mg/kg/week followed by maintenace dose of 2.2 mg/kg/week. Total duration of the study 24 months.
137297|NCT01801449|E1|Reported Event|Rilonacept Treatment|Rilonacept loading dose of 4.4 mg/kg/week followed by maintenace dose of 2.2 mg/kg/week. Total duration of the study 24 months.
137298|NCT01801436|B1|Baseline|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137299|NCT01801436|P1|Participant Flow|Bortezomib|Participants received 1.3 milligram per meter square (mg per m^2) of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137300|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137301|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137302|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137303|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137304|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137305|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137306|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137307|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137308|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137309|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137310|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137311|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137312|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137313|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137314|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137315|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137316|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137317|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137318|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137319|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137320|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137321|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137322|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137323|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
162177|NCT01704404|O4|Outcome|Dose 4 TD-4208|"175 µg~TD-4208"
137324|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137325|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137326|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137327|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137328|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137329|NCT01801436|E1|Reported Event|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
137330|NCT01801358|B7|Baseline|Total|Total of all reporting groups
137331|NCT01801358|B6|Baseline|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137332|NCT01801358|B5|Baseline|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137333|NCT01801358|B4|Baseline|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137334|NCT01801358|B3|Baseline|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137335|NCT01801358|B2|Baseline|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137336|NCT01801358|B1|Baseline|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137337|NCT01801358|P6|Participant Flow|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137338|NCT01801358|P5|Participant Flow|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137339|NCT01801358|P4|Participant Flow|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137340|NCT01801358|P3|Participant Flow|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137341|NCT01801358|P2|Participant Flow|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137342|NCT01801358|P1|Participant Flow|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137343|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137344|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137345|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137346|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137347|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137348|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137349|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137350|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137351|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137352|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137353|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137354|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137355|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137356|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137357|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137358|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137359|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137360|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137361|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137362|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137363|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137364|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137365|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137366|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137367|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137368|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137369|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137370|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137371|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137372|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137373|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137374|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137375|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137376|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137377|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137378|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137379|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137380|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137381|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137382|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137383|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137384|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137385|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137386|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137387|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137388|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137389|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137390|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137391|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137392|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137393|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137394|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137395|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137525|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
137396|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137397|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137398|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137399|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137400|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137401|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137402|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137403|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137404|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137405|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137406|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137407|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137408|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137409|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137410|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137411|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137412|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137413|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137414|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137415|NCT01801358|O1|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
137416|NCT01801358|O1|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
137417|NCT01801358|O1|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
137418|NCT01801358|O1|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
137419|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137420|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137421|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137422|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137423|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137424|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137425|NCT01801358|O1|Outcome|Phase Ib (Dose Escalation)|"For Phase Ib, a minimum of three patients will be entered into each cohort and evaluated for safety (DLTs and any other medically significant event) at the end of Cycle 1.~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137426|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137427|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
162178|NCT01704404|O3|Outcome|Dose 3 TD-4208|"88 µg~TD-4208"
137428|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137429|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137430|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137431|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137432|NCT01801358|O7|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
137433|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137434|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137435|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137436|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137437|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137438|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137439|NCT01801358|O7|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
137440|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137441|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137442|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137443|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137444|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137445|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137446|NCT01801358|O1|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
137447|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (DDS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137448|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (DDS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137449|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (DDS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137450|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (DDS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137451|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (DDS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137452|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (DDS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137453|NCT01801358|E6|Reported Event|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137454|NCT01801358|E5|Reported Event|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137455|NCT01801358|E4|Reported Event|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137456|NCT01801358|E3|Reported Event|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137457|NCT01801358|E2|Reported Event|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137458|NCT01801358|E1|Reported Event|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
137459|NCT01801280|B5|Baseline|Total|Total of all reporting groups
137460|NCT01801280|B4|Baseline|Sequence D|"st period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~nd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.~rd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.~th period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d."
137461|NCT01801280|B3|Baseline|Sequence C|"st period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~nd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~rd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.~th period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d."
137462|NCT01801280|B2|Baseline|Sequence B|"st period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.~nd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~rd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~th period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d."
137463|NCT01801280|B1|Baseline|Sequence A|"st period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.~nd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.~rd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~th period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d."
137464|NCT01801280|P4|Participant Flow|Sequence D|"st period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~nd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.~rd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.~th period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d."
137465|NCT01801280|P3|Participant Flow|Sequence C|"st period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~nd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~rd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.~th period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d."
137466|NCT01801280|P2|Participant Flow|Sequence B|"st period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.~nd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~rd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~th period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d."
137467|NCT01801280|P1|Participant Flow|Sequence A|"st period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.~nd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.~rd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~th period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d."
137468|NCT01801280|O4|Outcome|EC-MPS + PAN|"Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks.~Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg.~Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate sodium.~Pantoprazole tablet (PAN) once a day in the morning for two weeks."
137469|NCT01801280|O3|Outcome|EC-MPS|"Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks.~Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg."
137470|NCT01801280|O2|Outcome|MMF+PAN|"Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks.~Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg.~Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate mofetil.~Pantoprazole tablet (PAN) once a day in the morning for two weeks."
137471|NCT01801280|O1|Outcome|Mycophenolate Mofetil (MMF)|"Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks.~Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg."
137472|NCT01801280|E4|Reported Event|EC-MPS + PAN|"Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks.~Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg.~Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate sodium.~Pantoprazole tablet (PAN) once a day in the morning for two weeks."
137473|NCT01801280|E3|Reported Event|EC-MPS|"Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks.~Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg."
137474|NCT01801280|E2|Reported Event|MMF + PAN|"Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks.~Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg.~Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate mofetil.~Pantoprazole tablet (PAN) once a day in the morning for two weeks."
137475|NCT01801280|E1|Reported Event|Mycophenolate Mofetil (MMF)|"Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks.~Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg."
137476|NCT01801124|B1|Baseline|EXPAREL|undiluted EXPAREL 266 mg
137477|NCT01801124|P1|Participant Flow|EXPAREL|undiluted EXPAREL 266 mg
137478|NCT01801124|O1|Outcome|EXPAREL|Subjects receiving 266 mg EXPAREL to infiltrate into the bilateral TAPs.
137479|NCT01801124|O1|Outcome|EXPAREL|Subjects receiving 266 mg EXPAREL to infiltrate into the bilateral TAPs.
137480|NCT01801124|E1|Reported Event|EXPAREL|Subjects receiving 266 mg EXPAREL to infiltrate into the bilateral TAPs.
137481|NCT01801111|B1|Baseline|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
137482|NCT01801111|P1|Participant Flow|Alectinib|Participants received alectinib 600 milligrams (mg), capsule, orally, twice daily (BID), continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
137483|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
137484|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
137485|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
137486|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
137487|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
137488|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
137489|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
137490|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
137491|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
137492|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
137493|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
137494|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
137495|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
137496|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
137497|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
137498|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
137499|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
137500|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
137501|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
137502|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
137503|NCT01801111|E1|Reported Event|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
137504|NCT01800968|B3|Baseline|Total|Total of all reporting groups
137505|NCT01800968|B2|Baseline|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
137506|NCT01800968|B1|Baseline|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
137507|NCT01800968|P2|Participant Flow|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
137508|NCT01800968|P1|Participant Flow|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
137509|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
137510|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
137511|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
137512|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
137513|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
137514|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
137515|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
137516|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
137517|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
137518|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
137519|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
137520|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
137521|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
137522|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
137523|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
139821|NCT01788163|O8|Outcome|Indonesia|Subjects in Indonesia that meet I/E and population criteria
137527|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
137528|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
137529|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
137530|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
137531|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
137532|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
137533|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
137534|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
137535|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
137536|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
137537|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
137538|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
137539|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
137540|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
137541|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
137542|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
137543|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
137544|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
137545|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
137546|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
137547|NCT01800968|E2|Reported Event|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous (SQ) daily.~Placebo: Placebo"
137548|NCT01800968|E1|Reported Event|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous (SQ) daily.~Liraglutide: Active Drug"
137549|NCT01800916|B1|Baseline|Overall Study Population|
137550|NCT01800916|P9|Participant Flow|SenSura/Test C/Test B|The subjects first tested SenSura then Coloplast test product C and finally Coloplast test product B
137551|NCT01800916|P8|Participant Flow|SenSura/Test A/Test C|The subjects first tested SenSura then Coloplast test product A and finally Coloplast test product C
137552|NCT01800916|P7|Participant Flow|SenSura/Test A/Test B|The subjects first tested SenSura then Coloplast test product A and finally Coloplast test product B
137553|NCT01800916|P6|Participant Flow|Test C/SenSura/Test A|The subjects first tested Coloplast test product C then SenSura and finally Coloplast test product A
137554|NCT01800916|P5|Participant Flow|Test C/Test B/SenSura|The subjects first tested Coloplast test product C then Coloplast test product A and finally the comparator SenSura
137555|NCT01800916|P4|Participant Flow|Test B/SenSura/Test C|The subjects first tested Coloplast test product A then SenSura and finally Coloplast test product B
137556|NCT01800916|P3|Participant Flow|Test B/SenSura/Test A|The subjects first tested Coloplast test product B then SenSura and finally Coloplast test product A
137557|NCT01800916|P2|Participant Flow|Test A/Test C/SenSura|The subjects first tested Coloplast test product A then Coloplast test product C and finally the comparator SenSura
137558|NCT01800916|P1|Participant Flow|Test A/Test B/SenSura|The subjects first tested Coloplast test product A then Coloplast test product B and finally the comparator SenSura
137559|NCT01800916|O4|Outcome|SenSura|
137560|NCT01800916|O3|Outcome|Test C|
137561|NCT01800916|O2|Outcome|Test B|
137562|NCT01800916|O1|Outcome|Test A|
137563|NCT01800916|E4|Reported Event|SenSura|
137564|NCT01800916|E3|Reported Event|Test C|
137565|NCT01800916|E2|Reported Event|Test B|
137566|NCT01800916|E1|Reported Event|Test A|
137567|NCT01800903|B1|Baseline|All Participants|The intention to treat population consists of 36 healthy male subjects
137568|NCT01800903|P6|Participant Flow|ZN-C Catheter Then ZN-D Catheter Then SpeediCath Catheter|First ZN-C catheter then ZN-D catheter then SpeediCath catheter
137569|NCT01800903|P5|Participant Flow|ZN-C Catheter Then SpeediCath Catheter Then ZN-D Catheter|First ZN-C catheter then SpeediCath catheter then ZN-D catheter
137570|NCT01800903|P4|Participant Flow|ZN-D Catheter Then ZN-C Catheter Then SpeediCath Catheter|First ZN-D catheter then ZN-C catheter then SpeediCath catheter
137571|NCT01800903|P3|Participant Flow|ZN-D Catheter Then SpeediCath Catheter Then ZN-C Catheter|First ZN-D catheter then SpeediCath catheter then ZN-C catheter
137572|NCT01800903|P2|Participant Flow|SpeediCath Catheter Then ZN-C Catheter Then ZN-D Catheter|First SpeediCath catheter then ZN-C catheter then ZN-D catheter
137573|NCT01800903|P1|Participant Flow|SpeediCath Catheter Then ZN-D Catheter Then ZN-C Catheter|First SpeediCath catheter then ZN-D catheter then ZN-C catheter
137574|NCT01800903|O3|Outcome|SpeediCath|Subjects who tested the Speedicath catheter
137575|NCT01800903|O2|Outcome|ZN-C Catheter|Subjects who tested the ZN-C catheter
137576|NCT01800903|O1|Outcome|ZN-D Catheter|Subjects who tested the ZN-D catheter
137577|NCT01800903|E1|Reported Event|All Participants|"Data from subjects in the safety population. Definition of safety population: subjects that have given informed consent and have been exposed to at least one product.~However for 4 of these subjects no endpoint data was obtained and they were not included in the ITT population; they therefore do not appear in the participant flow module."
137578|NCT01800890|B1|Baseline|Overall Study Population|baseline data is given for subjects in the ITT population
139822|NCT01788163|O7|Outcome|Malaysia|Subjects in Malaysia that meet I/E and population criteria
137579|NCT01800890|P9|Participant Flow|SenSura/Test C/Test B|The subjects first tested the comparator product SenSura then Coloplast test product C and finally Cololpast test product B
137580|NCT01800890|P8|Participant Flow|SenSura/Test A/Test C|The subjects first tested the comparator product SenSura then Coloplast test product A and finally Cololpast test product C
137581|NCT01800890|P7|Participant Flow|SenSura/Test A/Test B|The subjects first tested the comparator product SenSura then Coloplast test product A and finally Cololpast test product B
137582|NCT01800890|P6|Participant Flow|Test C/ SenSura/ Test A|The subjects first tested Coloplast test product C then the comparator SenSura and finally Cololpast test product A
137583|NCT01800890|P5|Participant Flow|Test C/ Test B/ SenSura|The subjects first tested Coloplast test product C then Cololpast test product B and finally the comparator SenSura
137584|NCT01800890|P4|Participant Flow|Test B/ SenSura/ Test C|The subjects first tested Coloplast test product B then the comparator SenSura and finally Cololpast test product C
137585|NCT01800890|P3|Participant Flow|Test B/ SenSura/ Test A|The subjects first tested Coloplast test product B then the comparator SenSura and finally Cololpast test product A
137586|NCT01800890|P2|Participant Flow|Test A/ Test C/ SenSura|The subjects first tested Coloplast test product A then Cololpast test product C and finally the comparator SenSura
137587|NCT01800890|P1|Participant Flow|Test A/ Test B/ SenSura|The subjects first tested Coloplast test product A then Cololpast test product B and finally the comparator SenSura
137588|NCT01800890|O4|Outcome|SenSura|The comparator
137589|NCT01800890|O3|Outcome|Coloplast Test Product C|new test product
137590|NCT01800890|O2|Outcome|Coloplast Test Product B|new test product
137591|NCT01800890|O1|Outcome|Coloplast Test Product A|new test product
137592|NCT01800890|E4|Reported Event|SenSura|The comparator was the CE-marked product SenSura Click
137593|NCT01800890|E3|Reported Event|Coloplast Test Product C|Coloplast Test product C is a new test product
137594|NCT01800890|E2|Reported Event|Coloplast Test Product B|Coloplast Test product B is a new test product
137595|NCT01800890|E1|Reported Event|Coloplast Test Product A|Coloplast Test product A is a new test product
137596|NCT01800786|B3|Baseline|Total|Total of all reporting groups
137597|NCT01800786|B2|Baseline|OSA -no CPAP|newly diagnosed OSA patient will not wear CPAP for 3 months
137598|NCT01800786|B1|Baseline|OSA-CPAP Group|"OSA patient will use CPAP for 3 months~CPAP= continuous positive airway pressure therapy~OSA= obstructive sleep apnea"
137599|NCT01800786|P2|Participant Flow|OSA -no CPAP|newly diagnosed OSA patient will not wear CPAP for 3 months
137600|NCT01800786|P1|Participant Flow|OSA-CPAP Group|"OSA patient will use CPAP for 3 months~CPAP= continuous positive airway pressure therapy~OSA= obstructive sleep apnea"
137601|NCT01800786|O2|Outcome|OSA -no CPAP|newly diagnosed OSA patient will not wear CPAP for 3 months
137602|NCT01800786|O1|Outcome|OSA-CPAP Group|"OSA patient will use CPAP for 3 months~CPAP= continuous positive airway pressure therapy~OSA= obstructive sleep apnea"
137603|NCT01800786|E2|Reported Event|OSA -no CPAP|newly diagnosed OSA patient will not wear CPAP for 3 months
137604|NCT01800786|E1|Reported Event|OSA-CPAP Group|"OSA patient will use CPAP for 3 months~CPAP= continuous positive airway pressure therapy~OSA= obstructive sleep apnea"
137605|NCT01800318|B5|Baseline|Total|Total of all reporting groups
137606|NCT01800318|B4|Baseline|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
137607|NCT01800318|B3|Baseline|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
137608|NCT01800318|B2|Baseline|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed in treatment groups on the baby's legs. at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
137672|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137673|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137609|NCT01800318|B1|Baseline|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
137610|NCT01800318|P4|Participant Flow|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
137611|NCT01800318|P3|Participant Flow|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed on the baby's legs at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
137612|NCT01800318|P2|Participant Flow|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed in treatment groups on the baby's legs at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water:1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
137613|NCT01800318|P1|Participant Flow|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
137614|NCT01800318|O4|Outcome|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
137615|NCT01800318|O3|Outcome|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. ."
137616|NCT01800318|O2|Outcome|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. .(b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. .~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
139823|NCT01788163|O6|Outcome|Singapore|Subjects in Singapore that meet I/E and population criteria
137617|NCT01800318|O1|Outcome|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
137618|NCT01800318|O4|Outcome|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
137619|NCT01800318|O3|Outcome|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. ."
137620|NCT01800318|O2|Outcome|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. .(b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. .~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
137621|NCT01800318|O1|Outcome|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
137622|NCT01800318|O4|Outcome|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
137623|NCT01800318|O3|Outcome|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
137624|NCT01800318|O2|Outcome|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
138248|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
137625|NCT01800318|O1|Outcome|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
137626|NCT01800318|O4|Outcome|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
137627|NCT01800318|O3|Outcome|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
137628|NCT01800318|O2|Outcome|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
137629|NCT01800318|O1|Outcome|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
137630|NCT01800318|O4|Outcome|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
137631|NCT01800318|O3|Outcome|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed on the baby's legs at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
137632|NCT01800318|O2|Outcome|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed in treatment groups on the baby's legs at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water:1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
139824|NCT01788163|O5|Outcome|Thailand|Subjects in Thailand that meet I/E and population criteria
137633|NCT01800318|O1|Outcome|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
137634|NCT01800318|E4|Reported Event|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
137635|NCT01800318|E3|Reported Event|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
137636|NCT01800318|E2|Reported Event|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
137637|NCT01800318|E1|Reported Event|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
137638|NCT01800162|B4|Baseline|Total|Total of all reporting groups
137639|NCT01800162|B3|Baseline|Expectant Management|"Subjects will have their PPUL expectantly managed using serum hCG monitoring.~Expectant Management: Pregnancy will be expectantly managed using serum hcg monitoring."
137640|NCT01800162|B2|Baseline|Empiric Treatment With MTX for All|"Subjects will be treated with methotrexate, receiving one dose on day 0 and a subsequent dose on day 4. Additional doses will be administered as needed based on hCG levels.~Methotrexate: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels."
137641|NCT01800162|B1|Baseline|Uterine Evacuation, Then MTX for Some|"Subjects will undergo a uterine evacuation. If hCG levels do not sufficiently decrease after the uterine evacuation, the subject will be treated with methotrexate. If hCG levels do sufficiently decrease after the uterine evacuation, no further treatment is required.~Methotrexate: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels.~Uterine Evacuation: Uterine evacuation or dilation and curettage. At the clinician's discretion, this can be performed using local anesthesia, sedation or general anesthesia and can use a manual or electrical evacuation."
137642|NCT01800162|P3|Participant Flow|Expectant Management|"Subjects will have their PPUL expectantly managed using serum hCG monitoring.~Expectant Management: Pregnancy will be expectantly managed using serum hcg monitoring."
137643|NCT01800162|P2|Participant Flow|Empiric Treatment With MTX for All|"Subjects will be treated with methotrexate, receiving one dose on day 0 and a subsequent dose on day 4. Additional doses will be administered as needed based on hCG levels.~Methotrexate: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels."
137674|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137845|NCT01798992|E3|Reported Event|Carvedilol|"Idiopathic dilated cardiomyopathy patients who were randomized to receive carvedilol titrated to a goal of 25 mg by mouth twice daily for 18 months~Carvedilol"
137644|NCT01800162|P1|Participant Flow|Uterine Evacuation, Then MTX for Some|"Subjects will undergo a uterine evacuation. If hCG levels do not sufficiently decrease after the uterine evacuation, the subject will be treated with methotrexate. If hCG levels do sufficiently decrease after the uterine evacuation, no further treatment is required.~Methotrexate: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels.~Uterine Evacuation: Uterine evacuation or dilation and curettage. At the clinician's discretion, this can be performed using local anesthesia, sedation or general anesthesia and can use a manual or electrical evacuation."
137645|NCT01800162|O2|Outcome|Expectant Management|"Subjects will have their PPUL expectantly managed using serum hCG monitoring.~Expectant Management: Pregnancy will be expectantly managed using serum hcg monitoring."
137646|NCT01800162|O1|Outcome|Uterine Evacuation, Then MTX for Some|"Subjects will undergo a uterine evacuation. If hCG levels do not sufficiently decrease after the uterine evacuation, the subject will be treated with methotrexate. If hCG levels do sufficiently decrease after the uterine evacuation, no further treatment is required.~Methotrexate: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels.~Uterine Evacuation: Uterine evacuation or dilation and curettage. At the clinician's discretion, this can be performed using local anesthesia, sedation or general anesthesia and can use a manual or electrical evacuation."
137647|NCT01800162|O2|Outcome|Expectant Management|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
137648|NCT01800162|O1|Outcome|Uterine Evacuation|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
137649|NCT01800162|O2|Outcome|Expectant Management|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
137650|NCT01800162|O1|Outcome|Uterine Evacuation|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
137651|NCT01800162|O2|Outcome|Expectant Management|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
137652|NCT01800162|O1|Outcome|Uterine Evacuation|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
137653|NCT01800162|O2|Outcome|Expectant Management|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
137654|NCT01800162|O1|Outcome|Uterine Evacuation|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
137655|NCT01800162|O2|Outcome|Expectant Management|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
137656|NCT01800162|O1|Outcome|Uterine Evacuation|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
137657|NCT01800162|O2|Outcome|Expectant Management|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
137658|NCT01800162|O1|Outcome|Uterine Evacuation|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
137659|NCT01800162|O2|Outcome|Expectant Management|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
137660|NCT01800162|O1|Outcome|Uterine Evacuation|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
137661|NCT01800162|O2|Outcome|Expectant Management|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
137662|NCT01800162|O1|Outcome|Uterine Evacuation|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
137663|NCT01800162|O2|Outcome|Expectant Management|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
137664|NCT01800162|O1|Outcome|Uterine Evacuation|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
137665|NCT01800162|E2|Reported Event|Expectant Management|No AE to Report
137666|NCT01800162|E1|Reported Event|Uterine Evacuation|No AE to Report
137667|NCT01799941|B1|Baseline|Dextromethorphan Hydrobromide 20 mg + Quinidine Sulfate 10 mg|Participants who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137668|NCT01799941|P1|Participant Flow|Dextromethorphan Hydrobromide 20 mg + Quinidine Sulfate 10 mg|Participants who received fixed-dose combination of 20 milligram (mg) dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137669|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137670|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137671|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137675|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137676|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137677|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137678|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137679|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137680|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137681|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137682|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137683|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137684|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137685|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137686|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137687|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137688|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137689|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137690|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137691|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137692|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137693|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137694|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137695|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137696|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137759|NCT01799720|E2|Reported Event|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
137697|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137698|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137699|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137700|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137701|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137702|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137703|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137704|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137705|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137706|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137707|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137708|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137709|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137710|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137711|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137712|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137713|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137714|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137715|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137716|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137717|NCT01799941|E4|Reported Event|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137718|NCT01799941|E3|Reported Event|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137760|NCT01799720|E1|Reported Event|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
137719|NCT01799941|E2|Reported Event|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137720|NCT01799941|E1|Reported Event|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
137721|NCT01799720|B4|Baseline|Total|Total of all reporting groups
137722|NCT01799720|B3|Baseline|Only Diet|Participants from group 3 only received the diet. Follow-up 30 days.
137723|NCT01799720|B2|Baseline|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the most oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
137724|NCT01799720|B1|Baseline|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
137725|NCT01799720|P3|Participant Flow|Diet|Participants from group 3 took only diet, Follow-up 30 days
137726|NCT01799720|P2|Participant Flow|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules a day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet, Follow-up 30 days
137727|NCT01799720|P1|Participant Flow|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules a day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet, Follow-up 30 days
137728|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
137729|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
137730|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
137731|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
137732|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
137733|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
137734|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
137735|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
137736|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
137737|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
137738|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
137739|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
137740|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
137741|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
137742|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
137743|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
137744|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
137745|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
137746|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
137747|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
137748|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
137749|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
137750|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
137751|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
137752|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
137753|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
137754|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
137755|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
137756|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
137757|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
137758|NCT01799720|E3|Reported Event|Diet|Participants from group 3 only took diet. Follow-up 30 days.
137761|NCT01799590|B4|Baseline|Total|Total of all reporting groups
162179|NCT01704404|O2|Outcome|Dose 2 TD-4208|"44 µg~TD-4208"
137762|NCT01799590|B3|Baseline|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137763|NCT01799590|B2|Baseline|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137764|NCT01799590|B1|Baseline|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137765|NCT01799590|P3|Participant Flow|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137766|NCT01799590|P2|Participant Flow|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137767|NCT01799590|P1|Participant Flow|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137768|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137769|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137770|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137771|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137772|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137773|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137774|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137775|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137776|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137777|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137778|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137779|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137883|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
137780|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137781|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137782|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137783|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137784|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137785|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137786|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137787|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137788|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137789|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137790|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137791|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137792|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137793|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137794|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137795|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137796|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137797|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
138249|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
137798|NCT01799590|E3|Reported Event|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137799|NCT01799590|E2|Reported Event|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137800|NCT01799590|E1|Reported Event|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
137801|NCT01799278|B1|Baseline|All Patients|This is a single-arm, open-label Phase 2 trial evaluating MLN8237 in patients with histologically confirmed or clinically suspected metastatic neuroendocrine prostate cancer. Subjects will be treated with MLN8237 at 50 mg twice daily for 7 days repeated every 21 days. Individual dose reductions will be made on the basis of the AEs observed. Therapy will continue until disease progression, unacceptable toxicity as a result of MLN8237, or withdrawal of patient consent
137802|NCT01799278|P1|Participant Flow|All Patients|MLN8237 at 50 mg twice daily for 7 days repeated every 21 days.
137803|NCT01799278|O1|Outcome|All Patients|This is a single-arm, open-label Phase 2 trial evaluating MLN8237 in patients with histologically confirmed or clinically suspected metastatic neuroendocrine prostate cancer. Subjects will be treated with MLN8237 at 50 mg twice daily for 7 days repeated every 21 days. Individual dose reductions will be made on the basis of the AEs observed. Therapy will continue until disease progression, unacceptable toxicity as a result of MLN8237, or withdrawal of patient consent
137804|NCT01799278|O1|Outcome|All Patients|MLN8237 at 50 mg twice daily for 7 days repeated every 21 days.
137805|NCT01799278|O1|Outcome|All Patients|"MLN8237 at 50 mg twice daily for 7 days repeated every 21 days. Therapy will continue until disease progression, unacceptable toxicity as a result of MLN8237, or withdrawal of patient consent.~MLN8237: MLN8237 will be administered orally. The study drug will be administered on an empty stomach with the patient remaining nothing by mouth (NPO), except for water and prescribed medications, for 2 hours before and 1 hour after each dose. Patients will be instructed to take each oral dose of MLN8237 with 8 ounces (1 cup, 240 mL) of water."
137806|NCT01799278|O1|Outcome|ALL SUBJECTS|A single-arm, open-label Phase 2 trial evaluating MLN8237 in patients with histologically confirmed or clinically suspected metastatic neuroendocrine prostate cancer. Subjects will be treated with MLN8237 at 50 mg twice daily for 7 days repeated every 21 days.
137807|NCT01799278|O1|Outcome|All Patients|MLN8237 at 50 mg twice daily for 7 days repeated every 21 days. Therapy will continue until disease progression, unacceptable toxicity as a result of MLN8237, or withdrawal of patient consent. MLN8237: MLN8237 will be administered orally. The study drug will be administered on an empty stomach with the patient remaining nothing by mouth (NPO), except for water and prescribed medications, for 2 hours before and 1 hour after each dose. Patients will be instructed to take each oral dose of MLN8237 with 8 ounces (1 cup, 240 mL) of water.
137808|NCT01799278|E1|Reported Event|All Patients|"MLN8237 at 50 mg twice daily for 7 days repeated every 21 days. Therapy will continue until disease progression, unacceptable toxicity as a result of MLN8237, or withdrawal of patient consent.~MLN8237: MLN8237 will be administered orally. The study drug will be administered on an empty stomach with the patient remaining nothing by mouth (NPO), except for water and prescribed medications, for 2 hours before and 1 hour after each dose. Patients will be instructed to take each oral dose of MLN8237 with 8 ounces (1 cup, 240 mL) of water."
137809|NCT01799239|B1|Baseline|Overall Study|Describing baseline data for all subjects in the ITT population
137810|NCT01799239|P2|Participant Flow|First SenSura, Then Test Product|The subjects tested two products: In the first period the subjects tested the comparator SenSura. In the second period the subjects tested the newly developed ostomy bag called Test product
137811|NCT01799239|P1|Participant Flow|First Test Product; Then SenSura|The subjects tested two products: In the first period the subjects tested the newly developed ostomy bag called Test product. In the second period the subjects tested the comparator SenSura
137812|NCT01799239|O2|Outcome|SenSura|CE marked and launched SenSura used in this investigation is a 1-piece open appliance with the intended use being to collect output from an ileostomy.
137813|NCT01799239|O1|Outcome|Test Product|The new test product is a 1-piece open ostomy product with the intended use being collecting output from an ileostomy.
137814|NCT01799239|E2|Reported Event|SenSura|CE marked and launched SenSura used in this investigation is a 1-piece open appliance with the intended use being to collect output from an ileostomy.
137815|NCT01799239|E1|Reported Event|Test Product|The new test product is a 1-piece open ostomy product with the intended use being collecting output from an ileostomy.
137816|NCT01799226|B3|Baseline|Total|Total of all reporting groups
137817|NCT01799226|B2|Baseline|Test Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
137818|NCT01799226|B1|Baseline|Control Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
137819|NCT01799226|P2|Participant Flow|Test Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
137820|NCT01799226|P1|Participant Flow|Control Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
137821|NCT01799226|O2|Outcome|Test Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
137822|NCT01799226|O1|Outcome|Control Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
137823|NCT01799226|O2|Outcome|Test Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
137824|NCT01799226|O1|Outcome|Control Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
137825|NCT01799226|E2|Reported Event|Test Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
137826|NCT01799226|E1|Reported Event|Control Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
137827|NCT01798992|B5|Baseline|Total|Total of all reporting groups
137828|NCT01798992|B4|Baseline|Carvedilol|"Idiopathic dilated cardiomyopathy patients who were randomized to receive carvedilol titrated to a goal of 25 mg by mouth twice daily for 18 months~Carvedilol"
137829|NCT01798992|B3|Baseline|Metoprolol Succinate + Doxazosin|"Idiopathic dilated cardiomyopathy patients who were randomized to receive metoprolol succinate and doxazosin mesylate titrated to goals of 200 mg (metoprolol succinate) and 8 mg (doxazosin mesylate) by mouth daily for 18 months~Metoprolol succinate + doxazosin"
137830|NCT01798992|B2|Baseline|Metoprolol Succinate|"Idiopathic dilated cardiomyopathy patients randomized to metoprolol succinate titrated to a goal of 200 mg by mouth daily for 18 months~Metoprolol succinate"
137831|NCT01798992|B1|Baseline|Non-failing Control|Patients with normal ejection fraction who underwent a single myocardial biopsy and received no β-blocker therapy
137832|NCT01798992|P4|Participant Flow|Carvedilol|"Idiopathic dilated cardiomyopathy patients who were randomized to receive carvedilol titrated to a goal of 25 mg by mouth twice daily for 18 months~Carvedilol"
137833|NCT01798992|P3|Participant Flow|Metoprolol Succinate + Doxazosin|"Idiopathic dilated cardiomyopathy patients who were randomized to receive metoprolol succinate and doxazosin mesylate titrated to goals of 200 mg (metoprolol succinate) and 8 mg (doxazosin mesylate) by mouth daily for 18 months~Metoprolol succinate + doxazosin"
137834|NCT01798992|P2|Participant Flow|Metoprolol Succinate|"Idiopathic dilated cardiomyopathy patients randomized to metoprolol succinate titrated to a goal of 200 mg by mouth daily for 18 months~Metoprolol succinate"
137835|NCT01798992|P1|Participant Flow|Non-failing Control|Patients with normal ejection fraction who underwent a single myocardial biopsy and received no β-blocker therapy
137836|NCT01798992|O3|Outcome|Carvedilol|"Idiopathic dilated cardiomyopathy patients who were randomized to receive carvedilol titrated to a goal of 25 mg by mouth twice daily for 18 months~Carvedilol"
137837|NCT01798992|O2|Outcome|Metoprolol Succinate + Doxazosin|"Idiopathic dilated cardiomyopathy patients who were randomized to receive metoprolol succinate and doxazosin mesylate titrated to goals of 200 mg (metoprolol succinate) and 8 mg (doxazosin mesylate) by mouth daily for 18 months~Metoprolol succinate + doxazosin"
137838|NCT01798992|O1|Outcome|Metoprolol Succinate|"Idiopathic dilated cardiomyopathy patients randomized to metoprolol succinate titrated to a goal of 200 mg by mouth daily for 18 months~Metoprolol succinate"
137839|NCT01798992|O3|Outcome|Carvedilol|"Idiopathic dilated cardiomyopathy patients who were randomized to receive carvedilol titrated to a goal of 25 mg by mouth twice daily for 18 months~Carvedilol"
137840|NCT01798992|O2|Outcome|Metoprolol Succinate + Doxazosin|"Idiopathic dilated cardiomyopathy patients who were randomized to receive metoprolol succinate and doxazosin titrated to a goal of 200 mg and 8 mg by mouth daily for 18 months~Metoprolol succinate + doxazosin"
137841|NCT01798992|O1|Outcome|Metoprolol Succinate|"Idiopathic dilated cardiomyopathy patients randomized to metoprolol succinate titrated to a goal of 200 mg by mouth daily for 18 months~Metoprolol succinate"
137842|NCT01798992|O3|Outcome|Carvedilol|"Idiopathic dilated cardiomyopathy patients who were randomized to receive carvedilol titrated to a goal of 25 mg by mouth twice daily for 18 months~Carvedilol"
137843|NCT01798992|O2|Outcome|Metoprolol Succinate + Doxazosin|"Idiopathic dilated cardiomyopathy patients who were randomized to receive metoprolol succinate and doxazosin titrated to a goal of 200 mg and 8 mg by mouth daily for 18 months~Metoprolol succinate + doxazosin"
137844|NCT01798992|O1|Outcome|Metoprolol Succinate|"Idiopathic dilated cardiomyopathy patients randomized to metoprolol succinate titrated to a goal of 200 mg by mouth daily for 18 months~Metoprolol succinate"
137846|NCT01798992|E2|Reported Event|Metoprolol Succinate + Doxazosin|"Idiopathic dilated cardiomyopathy patients who were randomized to receive metoprolol succinate and doxazosin titrated to a goal of 200 mg and 8 mg by mouth daily for 18 months~Metoprolol succinate + doxazosin"
137847|NCT01798992|E1|Reported Event|Metoprolol Succinate|"Idiopathic dilated cardiomyopathy patients randomized to metoprolol succinate titrated to a goal of 200 mg by mouth daily for 18 months~Metoprolol succinate"
137848|NCT01798966|B1|Baseline|SENSIMED Triggerfish|All patients included in the device group
137849|NCT01798966|P1|Participant Flow|SENSIMED Triggerfish|All patients included in the device group
137850|NCT01798966|O1|Outcome|SENSIMED Triggerfish|SENSIMED Triggerfish worn for 24h
137851|NCT01798966|O1|Outcome|SENSIMED Triggerfish|All patients included in the device group
137852|NCT01798966|O1|Outcome|SENSIMED Triggerfish|SENSIMED Triggerfish worn for 24h
137853|NCT01798966|E1|Reported Event|SENSIMED Triggerfish|All patients included in the device group
137854|NCT01798927|B1|Baseline|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.~Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
137855|NCT01798927|P1|Participant Flow|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.~Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
137856|NCT01798927|O1|Outcome|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.~Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
137857|NCT01798927|O1|Outcome|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.~Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
137858|NCT01798927|O1|Outcome|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.~Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
137859|NCT01798927|E1|Reported Event|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.~Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
137860|NCT01798706|B3|Baseline|Total|Total of all reporting groups
137861|NCT01798706|B2|Baseline|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
137862|NCT01798706|B1|Baseline|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
137863|NCT01798706|P2|Participant Flow|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
137864|NCT01798706|P1|Participant Flow|Lixisenatide|Lixisenatide 10 mcg subcutaneously once daily (QD) for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
137865|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
137866|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
137867|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
137868|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
137869|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
137870|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
137871|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
137872|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
137873|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
137874|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
137875|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
137876|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
137877|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
137878|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
137879|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
137880|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
137881|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
137882|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
137884|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
137885|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
137886|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
137887|NCT01798706|E2|Reported Event|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks. (Median exposure: 169 days)
137888|NCT01798706|E1|Reported Event|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.(Median exposure: 169 days)
137889|NCT01798550|B3|Baseline|Total|Total of all reporting groups
137890|NCT01798550|B2|Baseline|Standard Dose (1 mg/kg)|"Enoxaparin 1 mg/kg (using total body weight) twice daily~Enoxaparin: Twice daily dosing"
137891|NCT01798550|B1|Baseline|Reduced Dose (0.8 mg/kg)|"Enoxaparin 0.8 mg/kg (using total body weight) twice daily~Enoxaparin: Twice daily dosing"
137892|NCT01798550|P2|Participant Flow|Standard Dose (1 mg/kg)|"Enoxaparin 1 mg/kg (using total body weight) twice daily~Enoxaparin: Twice daily dosing"
137893|NCT01798550|P1|Participant Flow|Reduced Dose (0.8 mg/kg)|"Enoxaparin 0.8 mg/kg (using total body weight) twice daily~Enoxaparin: Twice daily dosing"
137894|NCT01798550|O2|Outcome|Standard Dose (1 mg/kg)|"Enoxaparin 1 mg/kg (using total body weight) twice daily~Enoxaparin: Twice daily dosing"
137895|NCT01798550|O1|Outcome|Reduced Dose (0.8 mg/kg)|"Enoxaparin 0.8 mg/kg (using total body weight) twice daily~Enoxaparin: Twice daily dosing"
137896|NCT01798550|O2|Outcome|Standard Dose (1 mg/kg)|"Enoxaparin 1 mg/kg (using total body weight) twice daily~Enoxaparin: Twice daily dosing"
137897|NCT01798550|O1|Outcome|Reduced Dose (0.8 mg/kg)|"Enoxaparin 0.8 mg/kg (using total body weight) twice daily~Enoxaparin: Twice daily dosing"
137898|NCT01798550|O2|Outcome|Standard Dose (1 mg/kg)|"Enoxaparin 1 mg/kg (using total body weight) twice daily~Enoxaparin: Twice daily dosing"
137899|NCT01798550|O1|Outcome|Reduced Dose (0.8 mg/kg)|"Enoxaparin 0.8 mg/kg (using total body weight) twice daily~Enoxaparin: Twice daily dosing"
137900|NCT01798550|O2|Outcome|Standard Dose (1 mg/kg)|"Enoxaparin 1 mg/kg (using total body weight) twice daily~Enoxaparin: Twice daily dosing"
137901|NCT01798550|O1|Outcome|Reduced Dose (0.8 mg/kg)|"Enoxaparin 0.8 mg/kg (using total body weight) twice daily~Enoxaparin: Twice daily dosing"
137902|NCT01798550|O2|Outcome|Standard Dose (1 mg/kg)|"Enoxaparin 1 mg/kg (using total body weight) twice daily~Enoxaparin: Twice daily dosing"
137903|NCT01798550|O1|Outcome|Reduced Dose (0.8 mg/kg)|"Enoxaparin 0.8 mg/kg (using total body weight) twice daily~Enoxaparin: Twice daily dosing"
137904|NCT01798550|E2|Reported Event|Standard Dose (1 mg/kg)|"Enoxaparin 1 mg/kg (using total body weight) twice daily~Enoxaparin: Twice daily dosing"
137905|NCT01798550|E1|Reported Event|Reduced Dose (0.8 mg/kg)|"Enoxaparin 0.8 mg/kg (using total body weight) twice daily~Enoxaparin: Twice daily dosing"
137906|NCT01798485|B3|Baseline|Total|Total of all reporting groups
137907|NCT01798485|B2|Baseline|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
137908|NCT01798485|B1|Baseline|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
137909|NCT01798485|P2|Participant Flow|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
137910|NCT01798485|P1|Participant Flow|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
137911|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
137912|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
137913|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
137914|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
137915|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
137916|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
137917|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
137918|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
137919|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
137920|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
137921|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
139825|NCT01788163|O4|Outcome|Australia|Subjects in Australia that meet I/E and population criteria
137922|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
137923|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
137924|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
137925|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
137926|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
137927|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
137928|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
137929|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
137930|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
137931|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
137932|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
137933|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
137934|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
137935|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
137936|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
137937|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
137938|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
137939|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
137940|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
137941|NCT01798485|E2|Reported Event|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
137942|NCT01798485|E1|Reported Event|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
137943|NCT01798394|B3|Baseline|Total|Total of all reporting groups
137944|NCT01798394|B2|Baseline|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
137945|NCT01798394|B1|Baseline|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
137946|NCT01798394|P2|Participant Flow|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
137947|NCT01798394|P1|Participant Flow|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
137948|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
137949|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
137950|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
137951|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
137952|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
137953|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
137954|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
137955|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
137956|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
137957|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
137958|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
137959|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
137960|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
137961|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
137962|NCT01798394|E2|Reported Event|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
137963|NCT01798394|E1|Reported Event|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
137964|NCT01798316|B3|Baseline|Total|Total of all reporting groups
137965|NCT01798316|B2|Baseline|Standard of Care|"Standard of care pain management regimen including opioids~Standard of Care: No IV acetaminophen"
137966|NCT01798316|B1|Baseline|IV Acetaminophen|"IV Acetaminophen administered before PACU admission~IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes"
137967|NCT01798316|P2|Participant Flow|Standard of Care|"Standard of care pain management regimen including opioids~Standard of Care: without IV acetaminophen"
137968|NCT01798316|P1|Participant Flow|IV Acetaminophen|"IV Acetaminophen administered before PACU admission~IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes"
137969|NCT01798316|O2|Outcome|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU~No IV Acetaminophen"
137970|NCT01798316|O1|Outcome|IV Acetaminophen|"IV Acetaminophen administered on admission to PACU~IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
137971|NCT01798316|O2|Outcome|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU~No IV Acetaminophen"
137972|NCT01798316|O1|Outcome|IV Acetaminophen|"IV Acetaminophen administered on admission to PACU~IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
137973|NCT01798316|O2|Outcome|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU~No IV acetaminophen"
137974|NCT01798316|O1|Outcome|IV Acetaminophen|"IV Acetaminophen administered before PACU admission~IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
137975|NCT01798316|O2|Outcome|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU~No IV Acetaminophen"
137976|NCT01798316|O1|Outcome|IV Acetaminophen|"IV Acetaminophen administered on admission to PACU~IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
137977|NCT01798316|O2|Outcome|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU~No IV acetaminophen"
137978|NCT01798316|O1|Outcome|IV Acetaminophen|"IV Acetaminophen administered before PACU admission~IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
137979|NCT01798316|O2|Outcome|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU~No IV acetaminophen"
137980|NCT01798316|O1|Outcome|IV Acetaminophen|"IV Acetaminophen administered on admission to PACU~IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
137981|NCT01798316|O2|Outcome|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU~No IV Acetaminophen"
162180|NCT01704404|O1|Outcome|Dose 1 TD-4208|"22 µg~TD-4208"
137982|NCT01798316|O1|Outcome|IV Acetaminophen|"IV Acetaminophen administered on admission to PACU~IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
137983|NCT01798316|E2|Reported Event|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU~No IV acetaminophen"
137984|NCT01798316|E1|Reported Event|IV Acetaminophen|"IV Acetaminophen administered on admission to PACU~IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
137985|NCT01798264|B5|Baseline|Total|Total of all reporting groups
137986|NCT01798264|B4|Baseline|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
137987|NCT01798264|B3|Baseline|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
137988|NCT01798264|B2|Baseline|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
137989|NCT01798264|B1|Baseline|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
137990|NCT01798264|P4|Participant Flow|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
137991|NCT01798264|P3|Participant Flow|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
137992|NCT01798264|P2|Participant Flow|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
137993|NCT01798264|P1|Participant Flow|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
137994|NCT01798264|O4|Outcome|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
137995|NCT01798264|O3|Outcome|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
137996|NCT01798264|O2|Outcome|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
137997|NCT01798264|O1|Outcome|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
137998|NCT01798264|O4|Outcome|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
137999|NCT01798264|O3|Outcome|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
138000|NCT01798264|O2|Outcome|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
138001|NCT01798264|O1|Outcome|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
138002|NCT01798264|O4|Outcome|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
138003|NCT01798264|O3|Outcome|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
138004|NCT01798264|O2|Outcome|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
138005|NCT01798264|O1|Outcome|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
138006|NCT01798264|O4|Outcome|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
138007|NCT01798264|O3|Outcome|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
138008|NCT01798264|O2|Outcome|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
138009|NCT01798264|O1|Outcome|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
138010|NCT01798264|E4|Reported Event|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
138011|NCT01798264|E3|Reported Event|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
138012|NCT01798264|E2|Reported Event|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
138013|NCT01798264|E1|Reported Event|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
138014|NCT01798186|B5|Baseline|Total|Total of all reporting groups
138015|NCT01798186|B4|Baseline|Smokers|cannabis smokers
138016|NCT01798186|B3|Baseline|Cannabis 11% THC, Vent|passive exposure to 11% THC cannabis smoke, ventilated room
138017|NCT01798186|B2|Baseline|Cannabis 11% THC, no Vent|passive exposure to 11% THC cannabis smoke, unventilated room
138018|NCT01798186|B1|Baseline|Cannabis 5% THC, no Vent|passive exposure to 5% THC cannabis smoke, unventilated room
138019|NCT01798186|P4|Participant Flow|Active Smokers|Participants that smoked cannabis
138020|NCT01798186|P3|Participant Flow|Cannabis 11% THC, Ventilated|passive exposure to 11% THC cannabis smoke in a room with active air ventilation
138021|NCT01798186|P2|Participant Flow|Cannabis 11% THC, no Ventilation|passive exposure to 11% THC cannabis smoke in an unventilated room
138022|NCT01798186|P1|Participant Flow|Cannabis 5% THC, no Ventilation|passive exposure to 5% THC in an unventilated room
138023|NCT01798186|O3|Outcome|11% THC Cannabis, Ventilated|passive exposure to 11% THC cannabis smoke in ventilated room
138024|NCT01798186|O2|Outcome|11% THC Cannabis Smoke, no Vent|passive exposure to 11% THC cannabis smoke in unventilated room
138025|NCT01798186|O1|Outcome|5%THC, no Vent|passive 5% THC cannabis smoke, no room ventilation
138026|NCT01798186|O3|Outcome|11% THC Cannabis, no Ventilation|passive exposure to 5% THC cannabis smoke, with active room ventilation
138027|NCT01798186|O2|Outcome|11%THC Cannabis, no Ventilation|passive exposure to 11% THC cannabis smoke, no room ventilation
138028|NCT01798186|O1|Outcome|5%THC Cannabis, no Ventilation|passive exposure to 5% THC cannabis smoke, no room ventilation
138029|NCT01798186|O3|Outcome|11% THC Cannabis, Vent|passive exposure to 11% THC cannabis smoke in ventilated room
138030|NCT01798186|O2|Outcome|11% THC Cannabis Smoke, no Vent|passive exposure to 11% THC cannabis smoke in unventilated room
138031|NCT01798186|O1|Outcome|5% THC Cannabis, no Vent|passive exposure to 5%THC cannabis smoke in unventilated room
138032|NCT01798186|E3|Reported Event|11% THC Cannabis Smoke, Ventilation|passive exposure to 11%THC cannabis smoke in ventilated room
138033|NCT01798186|E2|Reported Event|11% THC Cannabis Smoke, no Ventilation|passive exposure to 11%THC cannabis smoke in unventilated room
138034|NCT01798186|E1|Reported Event|5% THC Cannabis Smoke, no Ventilation|passive exposure to 5%THC cannabis smoke in unventilated room
138035|NCT01798134|B1|Baseline|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)~Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin~TANDEM™"
138036|NCT01798134|P1|Participant Flow|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)~Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin~TANDEM™"
138037|NCT01798134|O1|Outcome|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)~Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin~TANDEM™"
138038|NCT01798134|O1|Outcome|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)~Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin~TANDEM™"
138039|NCT01798134|O1|Outcome|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)~Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin~TANDEM™"
138040|NCT01798134|O1|Outcome|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)~Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin~TANDEM™"
138041|NCT01798134|E1|Reported Event|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)~Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin~TANDEM™"
138042|NCT01798004|B1|Baseline|All Patients|Induction with multi-agent chemotherapy followed by Consolidation with BuMel chemotherapy + ASCT + XRT
138043|NCT01798004|P1|Participant Flow|All Patients|Induction with multi-agent chemotherapy followed by Consolidation with BuMel chemotherapy + ASCT + XRT
138044|NCT01798004|O1|Outcome|All Patients|Induction with multi-agent chemotherapy followed by Consolidation with BuMel Chemotherapy+ASCT+XRT
138045|NCT01798004|E1|Reported Event|All Patients|Induction with multi-agent chemotherapy followed by Consolidation with BuMel chemotherapy + ASCT + XRT
138046|NCT01797783|B3|Baseline|Total|Total of all reporting groups
138047|NCT01797783|B2|Baseline|Focus® DAILIES® Progressives|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
138048|NCT01797783|B1|Baseline|DAILIES® AquaComfort Plus® Multifocal|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
138049|NCT01797783|P2|Participant Flow|Focus® DAILIES® Progressives|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
138050|NCT01797783|P1|Participant Flow|DAILIES® AquaComfort Plus® Multifocal|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
138051|NCT01797783|O8|Outcome|FDP @ Day 30|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
138052|NCT01797783|O7|Outcome|FDP @ Day 14|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
138053|NCT01797783|O6|Outcome|FDP @ Day 3|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
138054|NCT01797783|O5|Outcome|FDP @ Dispense|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
138055|NCT01797783|O4|Outcome|DACP MF @ Day 30|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
138056|NCT01797783|O3|Outcome|DACP MF @ Day 14|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
138057|NCT01797783|O2|Outcome|DACP MF @ Day 3|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
138058|NCT01797783|O1|Outcome|DACP MF @ Dispense|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
138059|NCT01797783|O8|Outcome|FDP @ Day 30|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
138060|NCT01797783|O7|Outcome|FDP @ Day 14|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
138061|NCT01797783|O6|Outcome|FDP @ Day 3|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
138062|NCT01797783|O5|Outcome|FDP @ Dispense|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
138063|NCT01797783|O4|Outcome|DACP MF @ Day 30|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
138064|NCT01797783|O3|Outcome|DACP MF @ Day 14|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
138065|NCT01797783|O2|Outcome|DACP MF @ Day 3|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
138066|NCT01797783|O1|Outcome|DACP MF @ Dispense|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
138067|NCT01797783|O2|Outcome|Focus® DAILIES® Progressives|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
138068|NCT01797783|O1|Outcome|DAILIES® AquaComfort Plus® Multifocal|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
138069|NCT01797783|E2|Reported Event|Focus® DAILIES® Progressives|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
138070|NCT01797783|E1|Reported Event|DAILIES® AquaComfort Plus® Multifocal|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
138071|NCT01797731|B3|Baseline|Total|Total of all reporting groups
138072|NCT01797731|B2|Baseline|KneeAlign System|"Digital hand-held surgical navigation system for tibial component placement used by surgeon during surgery.~Digital hand-held surgical navigation system: Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty"
138073|NCT01797731|B1|Baseline|Conventional System|"Conventional tibial extramedullary alignment system used by surgeon during surgery.~Conventional tibial extramedullary alignment system: This is the standard of care for total knee arthroplasty."
138074|NCT01797731|P2|Participant Flow|KneeAlign System|"Digital hand-held surgical navigation system for tibial component placement used by surgeon during surgery.~Digital hand-held surgical navigation system: Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty"
138075|NCT01797731|P1|Participant Flow|Conventional System|"Conventional tibial extramedullary alignment system used by surgeon during surgery.~Conventional tibial extramedullary alignment system: This is the standard of care for total knee arthroplasty."
138076|NCT01797731|O2|Outcome|KneeAlign System|"Digital hand-held surgical navigation system for tibial component placement used by surgeon during surgery.~Digital hand-held surgical navigation system: Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty"
138077|NCT01797731|O1|Outcome|Conventional System|"Conventional tibial extramedullary alignment system used by surgeon during surgery.~Conventional tibial extramedullary alignment system: This is the standard of care for total knee arthroplasty."
138078|NCT01797731|O2|Outcome|KneeAlign System|"Digital hand-held surgical navigation system for tibial component placement used by surgeon during surgery.~Digital hand-held surgical navigation system: Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty"
138079|NCT01797731|O1|Outcome|Conventional System|"Conventional tibial extramedullary alignment system used by surgeon during surgery.~Conventional tibial extramedullary alignment system: This is the standard of care for total knee arthroplasty."
162181|NCT01704404|E7|Reported Event|Placebo|"Placebo~Placebo"
138080|NCT01797731|E2|Reported Event|KneeAlign System|"Digital hand-held surgical navigation system for tibial component placement used by surgeon during surgery.~Digital hand-held surgical navigation system: Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty"
138081|NCT01797731|E1|Reported Event|Conventional System|"Conventional tibial extramedullary alignment system used by surgeon during surgery.~Conventional tibial extramedullary alignment system: This is the standard of care for total knee arthroplasty."
138082|NCT01797705|B1|Baseline|All Evaluable Subjects|All subjects completing the one-night sleep study with evaluable results.
138083|NCT01797705|P1|Participant Flow|All Subjects|All enrolled subjects
138084|NCT01797705|O1|Outcome|All Evaluable Subjects|All subjects completing the one-night sleep study with evaluable results.
138085|NCT01797705|E1|Reported Event|Evaluable Subjects|All subjects completing the one-night sleep study with evaluable results.
138086|NCT01797575|B5|Baseline|Total|Total of all reporting groups
138087|NCT01797575|B4|Baseline|Sugar Pill|"research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Sugar Pill: research subject will be taking placebo in addition to his/her antidepressant and/or mood stabilizer medicine"
138088|NCT01797575|B3|Baseline|Aspirin and NAC|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.~Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
138089|NCT01797575|B2|Baseline|N-acetyl-cysteine|"research subject will be taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~N-acetyl-cysteine (NAC): taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
138090|NCT01797575|B1|Baseline|Aspirin|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine"
138091|NCT01797575|P4|Participant Flow|Sugar Pill|"research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Sugar Pill: research subject will be taking placebo in addition to his/her antidepressant and/or mood stabilizer medicine"
138092|NCT01797575|P3|Participant Flow|Aspirin and NAC|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.~Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
138093|NCT01797575|P2|Participant Flow|N-acetyl-cysteine|"research subject will be taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~N-acetyl-cysteine (NAC): taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
138094|NCT01797575|P1|Participant Flow|Aspirin|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine"
138095|NCT01797575|O4|Outcome|Sugar Pill|"research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Sugar Pill: research subject will be taking placebo in addition to his/her antidepressant and/or mood stabilizer medicine"
138096|NCT01797575|O3|Outcome|Aspirin and NAC|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.~Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
138097|NCT01797575|O2|Outcome|N-acetyl-cysteine|"research subject will be taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~N-acetyl-cysteine (NAC): taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
138098|NCT01797575|O1|Outcome|Aspirin|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine"
138099|NCT01797575|O4|Outcome|Sugar Pill|"research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Sugar Pill: research subject will be taking placebo in addition to his/her antidepressant and/or mood stabilizer medicine"
138100|NCT01797575|O3|Outcome|Aspirin and NAC|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.~Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
138161|NCT01797536|O3|Outcome|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
138101|NCT01797575|O2|Outcome|N-acetyl-cysteine|"research subject will be taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~N-acetyl-cysteine (NAC): taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
138102|NCT01797575|O1|Outcome|Aspirin|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine"
138103|NCT01797575|O4|Outcome|Sugar Pill|"research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Sugar Pill: research subject will be taking placebo in addition to his/her antidepressant and/or mood stabilizer medicine"
138104|NCT01797575|O3|Outcome|Aspirin and NAC|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.~Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
138105|NCT01797575|O2|Outcome|N-acetyl-cysteine|"research subject will be taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~N-acetyl-cysteine (NAC): taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
138106|NCT01797575|O1|Outcome|Aspirin|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine"
138107|NCT01797575|O4|Outcome|Sugar Pill|"research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Sugar Pill: research subject will be taking placebo in addition to his/her antidepressant and/or mood stabilizer medicine"
138108|NCT01797575|O3|Outcome|Aspirin and NAC|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.~Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
138109|NCT01797575|O2|Outcome|N-acetyl-cysteine|"research subject will be taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~N-acetyl-cysteine (NAC): taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
138110|NCT01797575|O1|Outcome|Aspirin|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine"
138111|NCT01797575|O4|Outcome|Sugar Pill|"research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Sugar Pill: research subject will be taking placebo in addition to his/her antidepressant and/or mood stabilizer medicine"
138112|NCT01797575|O3|Outcome|Aspirin and NAC|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.~Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
138113|NCT01797575|O2|Outcome|N-acetyl-cysteine|"research subject will be taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~N-acetyl-cysteine (NAC): taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
138114|NCT01797575|O1|Outcome|Aspirin|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine"
138115|NCT01797575|O4|Outcome|Sugar Pill|"research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Sugar Pill: research subject will be taking placebo in addition to his/her antidepressant and/or mood stabilizer medicine"
138116|NCT01797575|O3|Outcome|Aspirin and NAC|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.~Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
138117|NCT01797575|O2|Outcome|N-acetyl-cysteine|"research subject will be taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~N-acetyl-cysteine (NAC): taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
138162|NCT01797536|O2|Outcome|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
138118|NCT01797575|O1|Outcome|Aspirin|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine"
138119|NCT01797575|O4|Outcome|Sugar Pill|"research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Sugar Pill: research subject will be taking placebo in addition to his/her antidepressant and/or mood stabilizer medicine"
138120|NCT01797575|O3|Outcome|Aspirin and NAC|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.~Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
138121|NCT01797575|O2|Outcome|N-acetyl-cysteine|"research subject will be taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~N-acetyl-cysteine (NAC): taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
138122|NCT01797575|O1|Outcome|Aspirin|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine"
138123|NCT01797575|O4|Outcome|Placebo|research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
138124|NCT01797575|O3|Outcome|N-Acetyl Cysteine (NAC)|Examine efficacy of NAC in treating depression in bipolar patients in a double-blind placebo-controlled add-on design. Proportion of patients demonstrating > 50% decrease in depression scores on the MADRS, as a Function of Treatment (on NAC treatment only). (We completed follow-up analyses with a 30% MADRS improvement criterion due to our limited sample size compared to original goals, as we fell short on patient recruitment goals and ended up with a somewhat underpowered study.)
138125|NCT01797575|O2|Outcome|Aspirin|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine"
138126|NCT01797575|O1|Outcome|Aspirin and NAC|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.~Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
138127|NCT01797575|O4|Outcome|Placebo|research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
138128|NCT01797575|O3|Outcome|N-Acetyl Cysteine (NAC)|Examine efficacy of NAC in treating depression in bipolar patients in a double-blind placebo-controlled add-on design. Proportion of patients demonstrating > 50% decrease in depression scores on the MADRS, as a Function of Treatment (on NAC treatment only). (We completed follow-up analyses with a 30% MADRS improvement criterion due to our limited sample size compared to original goals, as we fell short on patient recruitment goals and ended up with a somewhat underpowered study.)
138129|NCT01797575|O2|Outcome|Aspirin|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine"
138130|NCT01797575|O1|Outcome|Aspirin and NAC|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.~Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
138131|NCT01797575|O4|Outcome|Placebo|research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
138132|NCT01797575|O3|Outcome|N-Acetyl Cysteine (NAC)|Examine efficacy of NAC in treating depression in bipolar patients in a double-blind placebo-controlled add-on design. Proportion of patients demonstrating > 50% decrease in depression scores on the MADRS, as a Function of Treatment (on NAC treatment only). (We completed follow-up analyses with a 30% MADRS improvement criterion due to our limited sample size compared to original goals, as we fell short on patient recruitment goals and ended up with a somewhat underpowered study.)
138133|NCT01797575|O2|Outcome|Aspirin|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine"
138134|NCT01797575|O1|Outcome|Aspirin and NAC|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.~Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
138135|NCT01797575|O4|Outcome|Placebo|research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
138136|NCT01797575|O3|Outcome|N-Acetyl Cysteine (NAC)|Examine efficacy of NAC in treating depression in bipolar patients in a double-blind placebo-controlled add-on design. Proportion of patients demonstrating > 50% decrease in depression scores on the MADRS, as a Function of Treatment (on NAC treatment only). (We completed follow-up analyses with a 30% MADRS improvement criterion due to our limited sample size compared to original goals, as we fell short on patient recruitment goals and ended up with a somewhat underpowered study.)
138137|NCT01797575|O2|Outcome|Aspirin|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine"
138138|NCT01797575|O1|Outcome|Aspirin and NAC|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.~Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
138139|NCT01797575|E4|Reported Event|Sugar Pill|"research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Sugar Pill: research subject will be taking placebo in addition to his/her antidepressant and/or mood stabilizer medicine"
138140|NCT01797575|E3|Reported Event|Aspirin and NAC|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.~Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
138141|NCT01797575|E2|Reported Event|N-acetyl-cysteine|"research subject will be taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~N-acetyl-cysteine (NAC): taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine"
138142|NCT01797575|E1|Reported Event|Aspirin|"research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations~Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine"
138143|NCT01797536|B5|Baseline|Total|Total of all reporting groups
138144|NCT01797536|B4|Baseline|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
138145|NCT01797536|B3|Baseline|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
138146|NCT01797536|B2|Baseline|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
138147|NCT01797536|B1|Baseline|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
138148|NCT01797536|P4|Participant Flow|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
138149|NCT01797536|P3|Participant Flow|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
138150|NCT01797536|P2|Participant Flow|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
138151|NCT01797536|P1|Participant Flow|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
138152|NCT01797536|O4|Outcome|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
138153|NCT01797536|O3|Outcome|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
138154|NCT01797536|O2|Outcome|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
138155|NCT01797536|O1|Outcome|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
138156|NCT01797536|O4|Outcome|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
138157|NCT01797536|O3|Outcome|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
138158|NCT01797536|O2|Outcome|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
138159|NCT01797536|O1|Outcome|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
138160|NCT01797536|O4|Outcome|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
138245|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
138163|NCT01797536|O1|Outcome|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
138164|NCT01797536|O4|Outcome|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
138165|NCT01797536|O3|Outcome|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
138166|NCT01797536|O2|Outcome|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
138167|NCT01797536|O1|Outcome|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
138168|NCT01797536|O4|Outcome|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
138169|NCT01797536|O3|Outcome|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
138170|NCT01797536|O2|Outcome|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
138171|NCT01797536|O1|Outcome|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
138172|NCT01797536|O4|Outcome|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
138173|NCT01797536|O3|Outcome|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
138174|NCT01797536|O2|Outcome|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
138175|NCT01797536|O1|Outcome|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
138176|NCT01797536|E4|Reported Event|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
138177|NCT01797536|E3|Reported Event|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
138178|NCT01797536|E2|Reported Event|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
138179|NCT01797536|E1|Reported Event|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
138180|NCT01797484|B3|Baseline|Total|Total of all reporting groups
138181|NCT01797484|B2|Baseline|No Additional Medication|No additional medication - control group
138182|NCT01797484|B1|Baseline|Ranolazine|"Ranolazine 500mg bid orally 7 days Ranolazine 750mg bid orally 35 days~Ranolazine: Improvement of myocardial microcirculation"
138183|NCT01797484|P2|Participant Flow|No Additional Medication|No additional medication - control group
138184|NCT01797484|P1|Participant Flow|Ranolazine|"Ranolazine 500mg bid orally 7 days Ranolazine 750mg bid orally 35 days~Ranolazine: Improvement of myocardial microcirculation"
138185|NCT01797484|O2|Outcome|No Additional Medication|No additional medication - control group
138186|NCT01797484|O1|Outcome|Ranolazine|"Ranolazine 500mg bid orally 7 days Ranolazine 750mg bid orally 35 days~Ranolazine: Improvement of myocardial microcirculation"
138187|NCT01797484|E2|Reported Event|No Additional Medication|No additional medication - control group
138188|NCT01797484|E1|Reported Event|Ranolazine|"Ranolazine 500mg bid orally 7 days Ranolazine 750mg bid orally 35 days~Ranolazine: Improvement of myocardial microcirculation"
138189|NCT01797471|B1|Baseline|LEAD RT|"Lattice Extreme Ablative Dose Radiation Therapy (RT) on Day 1 at dose of 18 Gy followed by;~Conventionally fractionated radiation therapy beginning on day 2 at 2 Gy per fraction for 30 fractions for a total dose of 60 Gy;~Conventional Platinum Chemotherapy Doublet at discretion of treating physician beginning on day 2.~Lattice Extreme Ablative Dose Radiation Therapy: A single fraction of LEAD RT, dose of 18 Gy will be delivered to subjects on day 1"
138190|NCT01797471|P1|Participant Flow|LEAD RT|"Lattice Extreme Ablative Dose Radiation Therapy (RT) on Day 1 at dose of 18 Gy followed by;~Conventionally fractionated radiation therapy beginning on day 2 at 2 Gy per fraction for 30 fractions for a total dose of 60 Gy;~Conventional Platinum Chemotherapy Doublet at discretion of treating physician beginning on day 2.~Lattice Extreme Ablative Dose Radiation Therapy: A single fraction of LEAD RT, dose of 18 Gy will be delivered to subjects on day 1"
138191|NCT01797471|O1|Outcome|LEAD RT|"Lattice Extreme Ablative Dose Radiation Therapy (RT) on Day 1 at dose of 18 Gy followed by;~Conventionally fractionated radiation therapy beginning on day 2 at 2 Gy per fraction for 30 fractions for a total dose of 60 Gy;~Conventional Platinum Chemotherapy Doublet at discretion of treating physician beginning on day 2.~Lattice Extreme Ablative Dose Radiation Therapy: A single fraction of LEAD RT, dose of 18 Gy will be delivered to subjects on day 1"
138192|NCT01797471|O1|Outcome|LEAD RT|"Lattice Extreme Ablative Dose Radiation Therapy (RT) on Day 1 at dose of 18 Gy followed by;~Conventionally fractionated radiation therapy beginning on day 2 at 2 Gy per fraction for 30 fractions for a total dose of 60 Gy;~Conventional Platinum Chemotherapy Doublet at discretion of treating physician beginning on day 2.~Lattice Extreme Ablative Dose Radiation Therapy: A single fraction of LEAD RT, dose of 18 Gy will be delivered to subjects on day 1"
138246|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
138193|NCT01797471|O1|Outcome|LEAD RT|"Lattice Extreme Ablative Dose Radiation Therapy (RT) on Day 1 at dose of 18 Gy followed by;~Conventionally fractionated radiation therapy beginning on day 2 at 2 Gy per fraction for 30 fractions for a total dose of 60 Gy;~Conventional Platinum Chemotherapy Doublet at discretion of treating physician beginning on day 2.~Lattice Extreme Ablative Dose Radiation Therapy: A single fraction of LEAD RT, dose of 18 Gy will be delivered to subjects on day 1"
138194|NCT01797471|O1|Outcome|LEAD RT|"Lattice Extreme Ablative Dose Radiation Therapy (RT) on Day 1 at dose of 18 Gy followed by;~Conventionally fractionated radiation therapy beginning on day 2 at 2 Gy per fraction for 30 fractions for a total dose of 60 Gy;~Conventional Platinum Chemotherapy Doublet at discretion of treating physician beginning on day 2.~Lattice Extreme Ablative Dose Radiation Therapy: A single fraction of LEAD RT, dose of 18 Gy will be delivered to subjects on day 1"
138195|NCT01797471|O1|Outcome|LEAD RT|"Lattice Extreme Ablative Dose Radiation Therapy (RT) on Day 1 at dose of 18 Gy followed by;~Conventionally fractionated radiation therapy beginning on day 2 at 2 Gy per fraction for 30 fractions for a total dose of 60 Gy;~Conventional Platinum Chemotherapy Doublet at discretion of treating physician beginning on day 2.~Lattice Extreme Ablative Dose Radiation Therapy: A single fraction of LEAD RT, dose of 18 Gy will be delivered to subjects on day 1"
138196|NCT01797471|O1|Outcome|LEAD RT|"Lattice Extreme Ablative Dose Radiation Therapy (RT) on Day 1 at dose of 18 Gy followed by;~Conventionally fractionated radiation therapy beginning on day 2 at 2 Gy per fraction for 30 fractions for a total dose of 60 Gy;~Conventional Platinum Chemotherapy Doublet at discretion of treating physician beginning on day 2.~Lattice Extreme Ablative Dose Radiation Therapy: A single fraction of LEAD RT, dose of 18 Gy will be delivered to subjects on day 1"
138197|NCT01797471|E1|Reported Event|LEAD RT|"Lattice Extreme Ablative Dose Radiation Therapy (RT) on Day 1 at dose of 18 Gy followed by;~Conventionally fractionated radiation therapy beginning on day 2 at 2 Gy per fraction for 30 fractions for a total dose of 60 Gy;~Conventional Platinum Chemotherapy Doublet at discretion of treating physician beginning on day 2.~Lattice Extreme Ablative Dose Radiation Therapy: A single fraction of LEAD RT, dose of 18 Gy will be delivered to subjects on day 1"
138198|NCT01797458|B4|Baseline|Total|Total of all reporting groups
138199|NCT01797458|B3|Baseline|Conventional Restoration|"Conventional Restoration: Technique:~Local anesthesia should be used when needed~Complete caries removal and cavity preparation~Use a matrix band and a wedge to tightly hold the band against the tooth~Place the material (Composite) under cotton wool roll isolation and continuous aspiration.~Check contacts and occlusion, and polish the restoration."
138200|NCT01797458|B2|Baseline|Non-Restorative Caries Treatment|"This is a less operative approach, here carious lesions are opened removing the overhanging enamel and making the cavity accessible for biofilm removal. No carious dentine was removed from the pulpal wall and no local anaesthesia was placed. Fluoride varnish (Duraphat, GABA, Lörrach, Germany) was applied to the cavity. Parents/children were trained to clean the cavity by brushing using a buccolingual technique.~Recall interval for these participants was every 3 months."
138201|NCT01797458|B1|Baseline|Hall Technique|"This technique uses preformed Stainless Steel Crowns (SSCs) to restore carious primary molars. Local anaesthesia, caries removal or tooth preparation are not required.~Hall Technique: Technique:~Removal of dental plaque and rest of aliments from the cavity~Selection of the SSC~If the contact points are very tight, orthodontic separator elastics could be placed through the mesial and distal contacts and the SSC has to be fitted at a subsequent appointment~Dry the crown and fill with glass-ionomer luting cement~Place the crown over the tooth~Removal of cement excesses from the crown margins~The child should be asked to keep biting on the crown until the cement has set"
138202|NCT01797458|P3|Participant Flow|Conventional Restoration|"Technique:~Local anaesthesia was used when needed~Complete caries removal and cavity preparation~Use a matrix band and a wedge to tightly hold the band against the tooth~Place the material (Compomer)~Check contacts and occlusion, and polish the restoration"
138203|NCT01797458|P2|Participant Flow|Non-Restorative Caries Treatment|"Carious lesions are opened removing the overhanging enamel and making the cavity accessible for biofilm removal. No carious dentine was removed from the pulpal wall and no local anaesthesia was placed. Fluoride varnish (Duraphat ®) was applied to the cavity. Parents/children were trained to clean the cavity by brushing using a buccolingual technique.~Recall intervals were every 3 months."
138204|NCT01797458|P1|Participant Flow|Hall Technique|"This technique uses preformed Stainless Steel Crowns (SSCs) to restore carious primary molars. Local anaesthesia, caries removal or tooth preparation are not required.~Technique:~Removal of dental plaque and rest of aliments from the cavity~Selection of the SSC~If the contact points are very tight, orthodontic separator elastics could be placed through the mesial and distal contacts and the SSC has to be fitted at a subsequent appointment~Dry the crown and fill with glass-ionomer luting cement~Place the crown over the tooth~Removal of cement excesses from the crown margins~The child should be asked to keep biting on the crown until the cement has set"
138205|NCT01797458|O3|Outcome|Conventional Restoration|A single assessment of participant´s pain perception during the conventional restoration was performed by the dentist using the Visual Analog Scale of Pain.
138206|NCT01797458|O2|Outcome|Non-Restorative Caries Treatment|A single assessment of participant´s pain perception during the Non-Restorative Caries Treatment was performed by the dentist using the Visual Analog Scale of Pain.
138207|NCT01797458|O1|Outcome|Hall Technique|A single assessment of participant´s pain perception during the Hall Technique was performed by the dentist using the Visual Analog Scale of Pain.
138208|NCT01797458|O3|Outcome|Conventional Restoration|A single assessment of participant´s behaviour during the conventional restoration was performed by the dentist using the Frankl Behavior Rating Scale.
138209|NCT01797458|O2|Outcome|Non-Restorative Caries Treatment|A single assessment of participant´s behaviour during the Non-Restorative Caries Treatment procedure was performed by the dentist using the Frankl Behavior Rating Scale.
138210|NCT01797458|O1|Outcome|Hall Technique|A single assessment of participant´s behaviour during the Hall Technique procedure was performed by the dentist using the Frankl Behavior Rating Scale.
138211|NCT01797458|O3|Outcome|Conventional Restoration|"Signs or symptoms of reversible pulpitis (no spontaneous pain) requiring pulpotomy. Signs or symptoms of irreversible pulpitis (history of spontaneous pain or precipitated pain caused by thermal or other stimuli) or dental abscess.~Restoration loss and tooth is unrestorable."
138247|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
138212|NCT01797458|O2|Outcome|Hall Technique|Irreversible pulpitis (history of spontaneous pain or precipitated pain caused by thermal or other stimuli) or dental abscess requiring pulpotomy or extraction Crown loss and tooth is unrestorable.
138213|NCT01797458|O1|Outcome|Non-Restorative Caries Treatment|Irreversible pulpitis (history of spontaneous pain or precipitated pain caused by thermal or other stimuli) or dental abscess requiring pulpotomy or extraction.
138214|NCT01797458|O3|Outcome|Conventional Restoration|"Conventional restorations (dental fillings) with complete caries removal will be performed. Local anaesthesia will be placed when needed. All cavities will be restored with Compomer (Dyract, Dentsply, Konstanz, Germany) under cotton wool roll isolation and continuous aspiration.~Technique:~Local anesthesia should be used when needed~Complete caries removal and cavity preparation~Use a matrix band and a wedge to tightly hold the band against the tooth~Place the material (Composer)~Check contacts and occlusion, and polish the restoration"
138215|NCT01797458|O2|Outcome|Non-Restorative Caries Treatment|"This is a less operative approach, here carious lesions are opened removing the overhanging enamel and making the cavity accessible for biofilm removal. No carious dentine will be removed from the pulpal wall and no local anaesthesia will be placed. Fluoride varnish (Duraphat, GABA, Lörrach, Germany) will be applied to the cavity. Parents/children will be trained to clean the cavity by brushing using a buccolingual technique.~Non-Restorative Caries Treatment: Technique:~Use high-speed bur to remove the undermined enamel and make the cavity accessible for plaque removal. Do not remove the contact area~Clean, dry the cavity and apply Duraphat® varnish fluoride (50/mg/ml)~Show the cavity to patient/parents and give them tooth-brushing instructions~Tell to parents that good plaque control is the key for this treatment~The recall interval for these patients is every 3 months."
138216|NCT01797458|O1|Outcome|Hall Technique|"This technique uses preformed Stainless Steel Crowns (SSCs) to restore carious primary molars. Local anaesthesia, caries removal or tooth preparation are not required.~Hall Technique: Technique:~Removal of dental plaque and rest of aliments from the cavity~Selection of the SSC~If the contact points are very tight, orthodontic separator elastics could be placed through the mesial and distal contacts and the SSC has to be fitted at a subsequent appointment~Dry the crown and fill with glass-ionomer luting cement~Place the crown over the tooth~Removal of cement excesses from the crown margins~The child should be asked to keep biting on the crown until the cement has set"
138217|NCT01797458|E3|Reported Event|Conventional Restoration|No observed/reported
138218|NCT01797458|E2|Reported Event|Non-Restorative Caries Treatment|No observed/reported
138219|NCT01797458|E1|Reported Event|Hall Technique|No observed/reported
138220|NCT01797445|B3|Baseline|Total|Total of all reporting groups
138221|NCT01797445|B2|Baseline|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
138222|NCT01797445|B1|Baseline|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
138223|NCT01797445|P2|Participant Flow|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
138224|NCT01797445|P1|Participant Flow|E/C/F/TAF|Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) placebo tablet administered orally once daily for 144 weeks
138225|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
138226|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
138227|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
138228|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
138229|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
138230|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
138231|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
138232|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
138233|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
138234|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
138235|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
138236|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
138237|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
138238|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
138239|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
138240|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
138241|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
138242|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
138243|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
138244|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
139826|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
138250|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
138251|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
138252|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
138253|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
138254|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
138255|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
138256|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
138257|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
138258|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
138259|NCT01797445|E2|Reported Event|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
138260|NCT01797445|E1|Reported Event|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
138261|NCT01797380|B3|Baseline|Total|Total of all reporting groups
138262|NCT01797380|B2|Baseline|Active Drug|Escitalopram tablet, 10mg, daily, 9 weeks.
138263|NCT01797380|B1|Baseline|Sugar Pill|Placebo
138264|NCT01797380|P2|Participant Flow|Active Drug|Escitalopram tablet, 10mg, daily, 9 weeks.
138265|NCT01797380|P1|Participant Flow|Sugar Pill|Placebo
138266|NCT01797380|O2|Outcome|Active Drug|Escitalopram tablet, 10mg, daily, 9 weeks.
138267|NCT01797380|O1|Outcome|Sugar Pill|Placebo
138268|NCT01797380|E2|Reported Event|Active Drug|Escitalopram tablet, 10mg, daily, 9 weeks.
138269|NCT01797380|E1|Reported Event|Sugar Pill|Placebo
138270|NCT01797328|B3|Baseline|Total|Total of all reporting groups
138271|NCT01797328|B2|Baseline|to Avoid Feeling Cold|"warm arm~warm arm: To the best of ability avoid feeling cold during 6 weeks"
138272|NCT01797328|B1|Baseline|Cold Provocation|"cold arm~cold arm: 1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering"
138273|NCT01797328|P2|Participant Flow|to Avoid Feeling Cold|"warm arm~warm arm: To the best of ability avoid feeling cold during 6 weeks"
138274|NCT01797328|P1|Participant Flow|Cold Provocation|"cold arm~cold arm: 1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering"
138275|NCT01797328|O2|Outcome|to Avoid Feeling Cold|"warm arm~warm arm: To the best of ability avoid feeling cold during 6 weeks"
138276|NCT01797328|O1|Outcome|Cold Provocation|"cold arm~cold arm: 1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering"
138277|NCT01797328|E2|Reported Event|to Avoid Feeling Cold|"warm arm~warm arm: To the best of ability avoid feeling cold during 6 weeks"
138278|NCT01797328|E1|Reported Event|Cold Provocation|"cold arm~cold arm: 1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering~no reported adverse events"
138279|NCT01797120|B3|Baseline|Total|Total of all reporting groups
138280|NCT01797120|B2|Baseline|Fulvestrant & Placebo|"Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus placebo daily x 12 cycles.~Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.~Placebo: Placebo for Everolimus (2 tablets) daily x 12 cycles. Placebo manufactured to mimic everolimus tablet."
138281|NCT01797120|B1|Baseline|Fulvestrant & Everolimus|"Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus everolimus daily x 12 cycles.~Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.~Everolimus: Everolimus 10 mg (2 tablets) daily x 12 cycles.~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity."
138282|NCT01797120|P2|Participant Flow|Fulvestrant & Placebo|"Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus placebo daily x 12 cycles.~Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.~Placebo: Placebo for Everolimus (2 tablets) daily x 12 cycles. Placebo manufactured to mimic everolimus tablet."
138283|NCT01797120|P1|Participant Flow|Fulvestrant & Everolimus|"Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus everolimus daily x 12 cycles.~Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.~Everolimus: Everolimus 10 mg (2 tablets) daily x 12 cycles.~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity."
138284|NCT01797120|O2|Outcome|Fulvestrant & Placebo|"Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus placebo daily x 12 cycles.~Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.~Placebo: Placebo for Everolimus (2 tablets) daily x 12 cycles. Placebo manufactured to mimic everolimus tablet."
138324|NCT01797081|O3|Outcome|Placebo|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
138285|NCT01797120|O1|Outcome|Fulvestrant & Everolimus|"Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus everolimus daily x 12 cycles.~Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.~Everolimus: Everolimus 10 mg (2 tablets) daily x 12 cycles.~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity."
138286|NCT01797120|O2|Outcome|Fulvestrant & Placebo|"Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus placebo daily x 12 cycles.~Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.~Placebo: Placebo for Everolimus (2 tablets) daily x 12 cycles. Placebo manufactured to mimic everolimus tablet."
138287|NCT01797120|O1|Outcome|Fulvestrant & Everolimus|"Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus everolimus daily x 12 cycles.~Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.~Everolimus: Everolimus 10 mg (2 tablets) daily x 12 cycles.~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity."
138288|NCT01797120|O2|Outcome|Fulvestrant & Placebo|"Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus placebo daily x 12 cycles.~Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.~Placebo: Placebo for Everolimus (2 tablets) daily x 12 cycles. Placebo manufactured to mimic everolimus tablet."
138289|NCT01797120|O1|Outcome|Fulvestrant & Everolimus|"Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus everolimus daily x 12 cycles.~Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.~Everolimus: Everolimus 10 mg (2 tablets) daily x 12 cycles.~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity."
138290|NCT01797120|O2|Outcome|Fulvestrant & Placebo|"Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus placebo daily x 12 cycles.~Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.~Placebo: Placebo for Everolimus (2 tablets) daily x 12 cycles. Placebo manufactured to mimic everolimus tablet."
138291|NCT01797120|O1|Outcome|Fulvestrant & Everolimus|"Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus everolimus daily x 12 cycles.~Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.~Everolimus: Everolimus 10 mg (2 tablets) daily x 12 cycles.~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity."
138292|NCT01797120|E2|Reported Event|Fulvestrant & Placebo|"Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus placebo daily x 12 cycles.~Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.~Placebo: Placebo for Everolimus (2 tablets) daily x 12 cycles. Placebo manufactured to mimic everolimus tablet."
138293|NCT01797120|E1|Reported Event|Fulvestrant & Everolimus|"Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus everolimus daily x 12 cycles.~Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.~Everolimus: Everolimus 10 mg (2 tablets) daily x 12 cycles.~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity."
138294|NCT01797094|B3|Baseline|Total|Total of all reporting groups
138295|NCT01797094|B2|Baseline|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138296|NCT01797094|B1|Baseline|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138297|NCT01797094|P2|Participant Flow|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138298|NCT01797094|P1|Participant Flow|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138299|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138300|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138301|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138302|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138303|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138304|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138305|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138306|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138307|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138308|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138309|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138310|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138311|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138312|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138313|NCT01797094|E2|Reported Event|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138314|NCT01797094|E1|Reported Event|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138315|NCT01797081|B5|Baseline|Total|Total of all reporting groups
138316|NCT01797081|B4|Baseline|Placebo/Botulinum Toxin Type A (12 U)|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (12 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
138317|NCT01797081|B3|Baseline|Placebo/Botulinum Toxin Type A (24 U)|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (24 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
138318|NCT01797081|B2|Baseline|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138319|NCT01797081|B1|Baseline|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138320|NCT01797081|P4|Participant Flow|Placebo/Botulinum Toxin Type A (12 U)|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (12 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
138321|NCT01797081|P3|Participant Flow|Placebo/Botulinum Toxin Type A (24 U)|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (24 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
138322|NCT01797081|P2|Participant Flow|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138323|NCT01797081|P1|Participant Flow|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138423|NCT01795937|B4|Baseline|Total|Total of all reporting groups
138325|NCT01797081|O2|Outcome|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138326|NCT01797081|O1|Outcome|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138327|NCT01797081|O3|Outcome|Placebo|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
138328|NCT01797081|O2|Outcome|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138329|NCT01797081|O1|Outcome|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138330|NCT01797081|O3|Outcome|Placebo|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
138331|NCT01797081|O2|Outcome|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138332|NCT01797081|O1|Outcome|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138333|NCT01797081|O3|Outcome|Placebo|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
138334|NCT01797081|O2|Outcome|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138335|NCT01797081|O1|Outcome|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138336|NCT01797081|E3|Reported Event|Placebo|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
138337|NCT01797081|E2|Reported Event|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138338|NCT01797081|E1|Reported Event|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
138339|NCT01797029|B3|Baseline|Total|Total of all reporting groups
138340|NCT01797029|B2|Baseline|Placebo|Inactive placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
138341|NCT01797029|B1|Baseline|Vaccine|A single dose of SIIL Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
138342|NCT01797029|P2|Participant Flow|Placebo|Inactive placebo will be identical to reconstituted Serum Institute of India, Ltd. (SIIL) LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
138343|NCT01797029|P1|Participant Flow|Vaccine|A single dose of Serum Institute of India, Ltd. (SIIL) Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
138344|NCT01797029|O2|Outcome|Placebo|Inactive placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
138345|NCT01797029|O1|Outcome|Vaccine|A single dose of SIIL Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
138346|NCT01797029|O2|Outcome|Placebo|Inactive placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
138347|NCT01797029|O1|Outcome|Vaccine|A single dose of SIIL Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
138348|NCT01797029|E2|Reported Event|Placebo|Inactive placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
138349|NCT01797029|E1|Reported Event|Vaccine|A single dose of SIIL Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
138350|NCT01796977|B1|Baseline|OxyGenesys Dissolved Oxygen Dressing and Gauze Dressing|"OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.~Standard Gauze Dressing: A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.~Each study participant was supposed to act as her own control (one breast to be treated with the test article, the other breast with the control article)."
138351|NCT01796977|P1|Participant Flow|OxyGenesys Dissolved Oxygen Dressing and Gauze Dressing|"OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.~Standard Gauze Dressing: A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.~Each study participant acted as her own control (one breast of each participant was treated with OxyGenesys, while the other breast was treated with the standard dressing (control))."
138352|NCT01796977|O2|Outcome|Standard Gauze Dressing|A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.
138353|NCT01796977|O1|Outcome|OxyGenesys Dissolved Oxygen Dressing|OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.
138354|NCT01796977|O1|Outcome|All Available Study Participants|Each study participant was treated with OxyGenesys Dissolved Oxygen Dressing on one breast and standard gauze dressing on the opposite breast.
138355|NCT01796977|O2|Outcome|Standard Gauze Dressing|A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.
138356|NCT01796977|O1|Outcome|OxyGenesys Dissolved Oxygen Dressing|OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.
138357|NCT01796977|O2|Outcome|Standard Gauze Dressing|"A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.~Standard Gauze Dressing"
138358|NCT01796977|O1|Outcome|OxyGenesys Dissolved Oxygen Dressing|"OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.~OxyGenesys Dissolved Oxygen Dressing"
138359|NCT01796977|E2|Reported Event|Standard Gauze Dressing|"A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.~Standard Gauze Dressing"
138360|NCT01796977|E1|Reported Event|OxyGenesys Dissolved Oxygen Dressing|"OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.~OxyGenesys Dissolved Oxygen Dressing"
138361|NCT01796964|B3|Baseline|Total|Total of all reporting groups
138362|NCT01796964|B2|Baseline|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
138363|NCT01796964|B1|Baseline|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
138364|NCT01796964|P2|Participant Flow|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
138365|NCT01796964|P1|Participant Flow|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
138366|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
138367|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
138368|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
138369|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
138370|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
138371|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
138372|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
138373|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
138374|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
138375|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
138376|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
138377|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
138378|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
138379|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
138380|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
138381|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
138382|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
138383|NCT01796964|E3|Reported Event|EYLEA|All subjects who were randomized and received at least 1 IVT injection of Aflibercept
138384|NCT01796964|E2|Reported Event|ESBA 1008|All subjects who were randomized and received at least 1 IVT injection of ESBA1008 solution
138385|NCT01796964|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study
138386|NCT01796860|B1|Baseline|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).~AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
138387|NCT01796860|P1|Participant Flow|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).~AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
138388|NCT01796860|O1|Outcome|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).~AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
138389|NCT01796860|O1|Outcome|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).~AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
138447|NCT01795937|O1|Outcome|Faldaprevir|"Faldaprevir 120 mg once daily from Day -4 to Day 1 with a 120 mg twice daily loading dose on Day -5 (6 days in total).~Treatment A."
138448|NCT01795937|O2|Outcome|Faldaprevir+Itraconazole|"Faldaprevir 120 mg once daily from Day -3 to Day 1 + itraconazole 200 mg twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).~Treatment B."
138390|NCT01796860|O1|Outcome|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).~AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
138391|NCT01796860|E1|Reported Event|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).~AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
138392|NCT01796548|B1|Baseline|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment. 'Number of participants analyzed for the baseline characteristic was intent-to-treat (ITT) population which included all randomly assigned participants who received at least 1 dose of study medication and fulfilled all eligibility criteria.'
138393|NCT01796548|P1|Participant Flow|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
138394|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
138395|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
138396|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
138397|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
138398|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
138399|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
138400|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
138401|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
138402|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
138403|NCT01796548|E1|Reported Event|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
138404|NCT01796236|B3|Baseline|Total|Total of all reporting groups
138405|NCT01796236|B2|Baseline|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
139706|NCT01788163|O2|Outcome|EGFR Mutation Negative|Participants who were EGFR Mutation Negative for the analysis population.
138406|NCT01796236|B1|Baseline|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
138407|NCT01796236|P2|Participant Flow|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
138408|NCT01796236|P1|Participant Flow|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
138409|NCT01796236|O2|Outcome|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
138410|NCT01796236|O1|Outcome|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
138411|NCT01796236|O2|Outcome|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
138412|NCT01796236|O1|Outcome|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
138413|NCT01796236|O2|Outcome|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
138414|NCT01796236|O1|Outcome|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
138415|NCT01796236|O2|Outcome|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
138416|NCT01796236|O1|Outcome|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
138417|NCT01796236|O2|Outcome|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
138418|NCT01796236|O1|Outcome|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
138419|NCT01796236|O2|Outcome|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
138420|NCT01796236|O1|Outcome|Minimally Invasive Surgery and BA400|"This arm involves no softtissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments)."
138421|NCT01796236|E2|Reported Event|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
138422|NCT01796236|E1|Reported Event|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
138424|NCT01795937|B3|Baseline|Treatment Sequence E_F (Statins Part)|"The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part.~Treatment E: Rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment F: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment E preceded treatment F.~Oral administration with 240 mL water."
138425|NCT01795937|B2|Baseline|Treatment Sequence C_D (Statins Part)|"The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part.~Treatment C: Atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment D: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment C preceded treatment D.~Oral administration with 240 mL water."
138426|NCT01795937|B1|Baseline|Treatment Sequence A_B (Itraconazole Part)|"The itraconazole part (interaction of steady state faldaprevir with itraconazole) of this trial was done open-label with a fixed-sequence, 2-period design; performed independently from the statins part.~Treatment A: Faldaprevir (120 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 1 (6 days in total).~Treatment B: Faldaprevir (120 mg) was given once daily from Day -3 to Day 1 (4 days). In addition, itraconazole (200 mg) was given twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).~Treatment A directly preceded treatment B, without an intermittent washout period.~Oral administration with 240 mL water."
138427|NCT01795937|P3|Participant Flow|Treatment Sequence E_F (Statins Part)|"The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part.~Treatment E: Rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment F: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment E preceded treatment F.~Oral administration with 240 mL water."
138428|NCT01795937|P2|Participant Flow|Treatment Sequence C_D (Statins Part)|"The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part.~Treatment C: Atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment D: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment C preceded treatment D.~Oral administration with 240 mL water."
138429|NCT01795937|P1|Participant Flow|Treatment Sequence A_B (Itraconazole Part)|"The itraconazole part (interaction of steady state faldaprevir with itraconazole) of this trial was done open-label with a fixed-sequence, 2-period design; performed independently from the statins part.~Treatment A: Faldaprevir (120 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 1 (6 days in total).~Treatment B: Faldaprevir (120 mg) was given once daily from Day -3 to Day 1 (4 days). In addition, itraconazole (200 mg) was given twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).~Treatment A directly preceded treatment B, without an intermittent washout period.~Oral administration with 240 mL water."
138430|NCT01795937|O2|Outcome|Rosuvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment F."
138431|NCT01795937|O1|Outcome|Rosuvastatin|"Rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment E."
138432|NCT01795937|O2|Outcome|Rosuvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment F."
138433|NCT01795937|O1|Outcome|Rosuvastatin|"Rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment E."
138434|NCT01795937|O2|Outcome|Rosuvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment F."
138435|NCT01795937|O1|Outcome|Rosuvastatin|"Rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment E."
138436|NCT01795937|O2|Outcome|Atorvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment D."
138437|NCT01795937|O1|Outcome|Atorvastatin|"Atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment C."
138438|NCT01795937|O2|Outcome|Rosuvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment F."
138439|NCT01795937|O1|Outcome|Atorvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment D."
138440|NCT01795937|O2|Outcome|Rosuvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment F."
138441|NCT01795937|O1|Outcome|Atorvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment D."
138442|NCT01795937|O2|Outcome|Atorvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment D."
138443|NCT01795937|O1|Outcome|Atorvastatin|"Atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment C."
138444|NCT01795937|O2|Outcome|Atorvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment D."
138445|NCT01795937|O1|Outcome|Atorvastatin|"Atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment C."
138446|NCT01795937|O2|Outcome|Faldaprevir+Itraconazole|"Faldaprevir 120 mg once daily from Day -3 to Day 1 + itraconazole 200 mg twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).~Treatment B."
139827|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
138449|NCT01795937|O1|Outcome|Faldaprevir|"Faldaprevir 120 mg once daily from Day -4 to Day 1 with a 120 mg twice daily loading dose on Day -5 (6 days in total).~Treatment A."
138450|NCT01795937|E7|Reported Event|Faldaprevir + Rosuvastatin (Statins Part)|"Faldaprevir: 240 mg was given twice daily on Day -5 and once daily from Day -4 to Day 2. Rosuvastatin: 10 mg was given as a single dose on Day 1.~Treatment F.~From the time of the combined administration of faldaprevir with rosuvastatin in treatment F until 1 day after the trial completion date."
138451|NCT01795937|E6|Reported Event|Faldaprevir + Atorvastatin (Statins Part)|"Faldaprevir: 240 mg was given twice daily on Day -5 and once daily from Day -4 to Day 2. Atorvastatin: 10 mg was given as a single dose on Day 1.~Treatment D.~From the time of the combined administration of faldaprevir with atorvastatin in treatment D until 1 day after the trial completion date."
138452|NCT01795937|E5|Reported Event|Faldaprevir (Statins Part)|From the time of the first faldaprevir administration in treatment D or F until the combined administration of faldaprevir with atorvastatin or rosuvastatin in treatment D or F, respectively, or until 1 day after the trial completion date.
138453|NCT01795937|E4|Reported Event|Rosuvastatin (Statins Part)|"Rosuvastatin: 10 mg was given as a single dose on Day 1.~Treatment E.~From the time of the single dose rosuvastatin administration in treatment E until the time of the first faldaprevir administration in treatment F or until 1 day after the trial completion date."
138454|NCT01795937|E3|Reported Event|Atorvastatin (Statins Part)|"Atorvastatin: 10 mg was given as a single dose on Day 1.~Treatment C.~From the time of the single dose atorvastatin administration in treatment C until the time of the first faldaprevir administration in treatment D or until 1 day after the trial completion date of the respective subject."
138455|NCT01795937|E2|Reported Event|Faldaprevir+Itraconazole (Itraconazole Part)|"Faldaprevir: 120 mg once daily. Itraconazole: 200 mg once daily with a 200 mg twice daily loading dose on Day -3.~Treatment B."
138456|NCT01795937|E1|Reported Event|Faldaprevir (Itraconazole Part)|"Faldaprevir: 120 mg once daily with a 120 mg twice daily loading dose on Day -5.~Treatment A."
138457|NCT01795898|B1|Baseline|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
138458|NCT01795898|P1|Participant Flow|Fentanyl|Fentanyl transdermal (through the skin) patches releasing 12.5 microgram (mcg) of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
138459|NCT01795898|O1|Outcome|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
138460|NCT01795898|O1|Outcome|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
138461|NCT01795898|O1|Outcome|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
138462|NCT01795898|O1|Outcome|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
138463|NCT01795898|O1|Outcome|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
138464|NCT01795898|E1|Reported Event|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
138465|NCT01795859|B3|Baseline|Total|Total of all reporting groups
138466|NCT01795859|B2|Baseline|SD-809 Placebo|Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
138467|NCT01795859|B1|Baseline|SD-809 Tablets|SD-809: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).
138468|NCT01795859|P2|Participant Flow|SD-809 Placebo|Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
138469|NCT01795859|P1|Participant Flow|SD-809 Tablets|SD-809: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).
138470|NCT01795859|O2|Outcome|SD-809 Placebo|Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
138471|NCT01795859|O1|Outcome|SD-809 Tablets|SD-809: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).
138472|NCT01795859|O2|Outcome|SD-809 Placebo|Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
138473|NCT01795859|O1|Outcome|SD-809 Tablets|SD-809: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).
138474|NCT01795859|O2|Outcome|SD-809 Placebo|Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
138475|NCT01795859|O1|Outcome|SD-809 Tablets|SD-809: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).
138476|NCT01795859|O2|Outcome|SD-809 Placebo|Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
138477|NCT01795859|O1|Outcome|SD-809 Tablets|SD-809: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).
138478|NCT01795859|O2|Outcome|SD-809 Placebo|Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
138479|NCT01795859|O1|Outcome|SD-809 Tablets|SD-809: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).
138480|NCT01795859|E2|Reported Event|SD-809|SD-809
138481|NCT01795859|E1|Reported Event|Placebo|Placebo
138482|NCT01795716|B3|Baseline|Total|Total of all reporting groups
138506|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
139828|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
138483|NCT01795716|B2|Baseline|Glivec First, Then Mesylate Imatinib Capsule|Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Glivec during the first study period. In the first phase of the multiple-dose administration, the groups were given Glivec 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Mesylate Imatinib Capsule was administered under the same protocol .
138484|NCT01795716|B1|Baseline|Mesylate Imatinib Capsule First, Then Glivec|Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule during the first study period. In the first phase of the multiple-dose administration, the groups were given Mesylate Imatinib Capsule 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Glivec was administered under the same protocol .
138485|NCT01795716|P2|Participant Flow|Glivec First, Then Mesylate Imatinib Capsule|Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Glivec during the first study period. In the first phase of the multiple-dose administration, the groups were given Glivec 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Mesylate Imatinib Capsule was administered under the same protocol .
138486|NCT01795716|P1|Participant Flow|Mesylate Imatinib Capsule First, Then Glivec|Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule during the first study period.In the first phase of the multiple-dose administration, the groups were given Mesylate Imatinib Capsule 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Glivec was administered under the same protocol .
138487|NCT01795716|O2|Outcome|Glivec|Eligible subjects were assigned to receive a single and multiple 400 mg oral dose Glivec
138488|NCT01795716|O1|Outcome|Mesylate Imatinib Capsule|Eligible subjects were assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule
138489|NCT01795716|E2|Reported Event|Glivec|Subjects were assigned to receive a single and multiple 400 mg oral dose Glivec
138490|NCT01795716|E1|Reported Event|Mesylate Imatinib Capsule|Subjects were assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule
138491|NCT01795547|B3|Baseline|Total|Total of all reporting groups
138492|NCT01795547|B2|Baseline|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
138493|NCT01795547|B1|Baseline|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
138494|NCT01795547|P2|Participant Flow|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
138495|NCT01795547|P1|Participant Flow|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
138496|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
138497|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
138498|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
138499|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
138500|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
138501|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
138502|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
138503|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
138504|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
138505|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
139707|NCT01788163|O1|Outcome|EGFR Mutation Positive|Participants who were EGFR Mutation Positive for the analysis population.
138507|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
138508|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
138509|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
138510|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
138511|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
138512|NCT01795547|O2|Outcome|Paliperidone|Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by 2 paliperidone palmitate IM injections at Weeks 3 and 4, respectively. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.
138513|NCT01795547|O1|Outcome|Aripiprazole|Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection at the end of Week 4. Oral tablets were taken for 2 more weeks after the 1st injection. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.
138514|NCT01795547|E2|Reported Event|PALIPERIDONE|Safety data is based on all patients who received study medicine.
138515|NCT01795547|E1|Reported Event|ARIPIPRAZOLE|Safety data is based on all patients who received study medicine.
138516|NCT01795534|B1|Baseline|All Participants|Includes groups randomized to receive beetroot shot first and placebo first.
138517|NCT01795534|P2|Participant Flow|Placebo Shot Then Beetroot Shot|"Intervention: participants will first consume a Nitrate-depleted beetroot shot: 1x70ml nitrate-depleted beetroot Placebo shot (~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK)~Following a four day wash out, participants will then consume a Beetroot shot: 1x70ml concentrated NO-3 shot of rich Beetroot juice (~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK)."
138518|NCT01795534|P1|Participant Flow|Beetroot Shot Then Placebo Shot|"Intervention: Participants will first consume a Beetroot shot: 1x70ml concentrated NO-3 shot of rich Beetroot juice (~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK).~Following a four day wash out, participants will then consume a Nitrate-depleted beetroot shot: 1x70ml nitrate-depleted beetroot Placebo shot (~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK)"
138519|NCT01795534|O2|Outcome|Placebo Shot|"Includes groups randomized to receive beetroot first and placebo first.~Data is for all participants following consumption of 1x70ml nitrate-depleted beetroot shot (~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK)."
138520|NCT01795534|O1|Outcome|Beetroot Shot|"Includes groups randomized to receive beetroot first and placebo first.~Data is for all participants following consumption of 1x70ml concentrated NO-3 shot of rich beetroot juice (~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK)."
138521|NCT01795534|E2|Reported Event|Placebo Shot|Data is for all participants following consumption of 1x70ml nitrate-depleted beetroot shot (~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK).
138522|NCT01795534|E1|Reported Event|Beetroot Shot|Data is for all participants following consumption of 1x70ml concentrated NO-3 shot of rich beetroot juice (~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK).
138523|NCT01795495|B4|Baseline|Total|Total of all reporting groups
138524|NCT01795495|B3|Baseline|Remifentanil Plus Magnesium|"This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.~Magnesium Sulfate: This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour)."
138525|NCT01795495|B2|Baseline|Remifentanil Plus Methadone|"This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.~Methadone hydrochloride: This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia"
138526|NCT01795495|B1|Baseline|Remifentanil|"This arm will receive remifentanil alone as is the current practice.~Remifentanil"
138527|NCT01795495|P3|Participant Flow|Remifentanil Plus Magnesium|"This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.~Magnesium Sulfate: This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour)."
138528|NCT01795495|P2|Participant Flow|Remifentanil Plus Methadone|"This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.~Methadone hydrochloride: This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia"
138529|NCT01795495|P1|Participant Flow|Remifentanil|"This arm will receive remifentanil alone as is the current practice.~Remifentanil"
138530|NCT01795495|O3|Outcome|Remifentanil Plus Magnesium|"This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.~Magnesium Sulfate: This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour)."
138531|NCT01795495|O2|Outcome|Remifentanil Plus Methadone|"This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.~Methadone hydrochloride: This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia"
138532|NCT01795495|O1|Outcome|Remifentanil|"This arm will receive remifentanil alone as is the current practice.~Remifentanil"
138533|NCT01795495|O3|Outcome|Remifentanil Plus Magnesium|"This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.~Magnesium Sulfate: This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour)."
138534|NCT01795495|O2|Outcome|Remifentanil Plus Methadone|"This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.~Methadone hydrochloride: This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia"
138535|NCT01795495|O1|Outcome|Remifentanil|"This arm will receive remifentanil alone as is the current practice.~Remifentanil"
138536|NCT01795495|E3|Reported Event|Remifentanil Plus Magnesium|"This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.~Magnesium Sulfate: This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour)."
138537|NCT01795495|E2|Reported Event|Remifentanil Plus Methadone|"This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.~Methadone hydrochloride: This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia"
138538|NCT01795495|E1|Reported Event|Remifentanil|"This arm will receive remifentanil alone as is the current practice.~Remifentanil"
138539|NCT01794949|B3|Baseline|Total|Total of all reporting groups
138540|NCT01794949|B2|Baseline|NIDDM Patients Receiving the Resolute Stent|Non–insulin-dependent diabetes mellitus (NIDDM) patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
138541|NCT01794949|B1|Baseline|Non-diabetic Patients Receiving the Resolute Stent|Non-diabetic patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
138542|NCT01794949|P2|Participant Flow|NIDDM Patients Receiving the Resolute Stent|Non–insulin-dependent diabetes mellitus (NIDDM) patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
138543|NCT01794949|P1|Participant Flow|Non-diabetic Patients Receiving the Resolute Stent|Non-diabetic patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
138544|NCT01794949|O2|Outcome|NIDDM Patients Receiving the Resolute Stent|Non–insulin-dependent diabetes mellitus (NIDDM) patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
138545|NCT01794949|O1|Outcome|Non-diabetic Patients Receiving the Resolute Stent|Non-diabetic patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
138546|NCT01794949|E2|Reported Event|NIDDM Patients Receiving the Resolute Stent|Non–insulin-dependent diabetes mellitus (NIDDM) patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
138547|NCT01794949|E1|Reported Event|Non-diabetic Patients Receiving the Resolute Stent|Non-diabetic patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
138548|NCT01794936|B1|Baseline|VTI Probe or Non-Probe|Data per arm is not available. Columbia will never have access to this data.
138549|NCT01794936|P1|Participant Flow|VTI Probe or Non-Probe|Data per arm is not available. Columbia will never have access to this data.
138550|NCT01794936|O1|Outcome|VTI Probe or Non-Probe|Data per arm is not available. Columbia will never have access to this data.
138551|NCT01794936|O1|Outcome|VTI Probe or Non-Probe|Data per arm is not available. Columbia will never have access to this data.
138552|NCT01794936|E1|Reported Event|VTI Probe or Non-Probe|Data per arm is not available. Columbia will never have access to this data.
138553|NCT01794845|B1|Baseline|Erbitux, Taxotere, LD Fractionated RT|"Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):~Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.~Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.~Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy."
138554|NCT01794845|P1|Participant Flow|Erbitux, Taxotere, LD Fractionated RT|"Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):~Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.~Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.~Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy."
138555|NCT01794845|O1|Outcome|Erbitux, Taxotere, LD Fractionated RT|"Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):~Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.~Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.~Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy."
138556|NCT01794845|O1|Outcome|Erbitux, Taxotere, LD Fractionated RT|"Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):~Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.~Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.~Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy."
138590|NCT01794455|O1|Outcome|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
138591|NCT01794455|O2|Outcome|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
138557|NCT01794845|O1|Outcome|Erbitux, Taxotere, LD Fractionated RT|"Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):~Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.~Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.~Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy."
138558|NCT01794845|O1|Outcome|Erbitux, Taxotere, LD Fractionated RT|"Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):~Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.~Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.~Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy."
138559|NCT01794845|E1|Reported Event|Erbitux, Taxotere, LD Fractionated RT|"Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):~Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.~Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.~Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy."
138560|NCT01794806|B3|Baseline|Total|Total of all reporting groups
138561|NCT01794806|B2|Baseline|Tooth Extraction|"Tooth extraction~Tooth extraction: Minimally traumatic single-rooted tooth extraction"
138562|NCT01794806|B1|Baseline|Tooth Extraction and Grafting|"Tooth extraction and grafting with allograft~Tooth extraction and grafting with allograft: Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane"
138563|NCT01794806|P2|Participant Flow|Tooth Extraction|"Tooth extraction~Tooth extraction: Minimally traumatic single-rooted tooth extraction"
138564|NCT01794806|P1|Participant Flow|Tooth Extraction and Grafting|"Tooth extraction and grafting with allograft~Tooth extraction and grafting with allograft: Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane"
138565|NCT01794806|O2|Outcome|Tooth Extraction|"Tooth extraction~Tooth extraction: Minimally traumatic single-rooted tooth extraction"
138566|NCT01794806|O1|Outcome|Tooth Extraction and Grafting|"Tooth extraction and grafting with allograft~Tooth extraction and grafting with allograft: Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane"
138567|NCT01794806|O2|Outcome|Tooth Extraction|"Tooth extraction~Tooth extraction: Minimally traumatic single-rooted tooth extraction"
138568|NCT01794806|O1|Outcome|Tooth Extraction and Grafting|"Tooth extraction and grafting with allograft~Tooth extraction and grafting with allograft: Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane"
138569|NCT01794806|O2|Outcome|Tooth Extraction|"Tooth extraction~Tooth extraction: Minimally traumatic single-rooted tooth extraction"
138570|NCT01794806|O1|Outcome|Tooth Extraction and Grafting|"Tooth extraction and grafting with allograft~Tooth extraction and grafting with allograft: Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane"
138571|NCT01794806|E2|Reported Event|Tooth Extraction|"Tooth extraction~Tooth extraction: Minimally traumatic single-rooted tooth extraction"
138572|NCT01794806|E1|Reported Event|Tooth Extraction and Grafting|"Tooth extraction and grafting with allograft~Tooth extraction and grafting with allograft: Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane"
138573|NCT01794741|B3|Baseline|Total|Total of all reporting groups
138574|NCT01794741|B2|Baseline|Fluticasone Propionate Nasal Spray|"fluticasone propionate nasal spray 50mcg per spray per nostril twice a day~Fluticasone propionate nasal spray"
138575|NCT01794741|B1|Baseline|Dymista Nasal Spray|"azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months~Dymista Nasal Spray"
138576|NCT01794741|P2|Participant Flow|Fluticasone Propionate Nasal Spray|"fluticasone propionate nasal spray 50mcg per spray per nostril twice a day~Fluticasone propionate nasal spray"
138577|NCT01794741|P1|Participant Flow|Dymista Nasal Spray|"azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months~Dymista Nasal Spray"
138578|NCT01794741|O2|Outcome|Fluticasone Nasal Spray|
138579|NCT01794741|O1|Outcome|Dymista Nasal Spray|
138580|NCT01794741|E2|Reported Event|Fluticasone Propionate Nasal Spray|"fluticasone propionate nasal spray 50mcg per spray per nostril twice a day~Fluticasone propionate nasal spray"
138581|NCT01794741|E1|Reported Event|Dymista Nasal Spray|"azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months~Dymista Nasal Spray"
138582|NCT01794455|B3|Baseline|Total|Total of all reporting groups
138583|NCT01794455|B2|Baseline|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
138584|NCT01794455|B1|Baseline|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
138585|NCT01794455|P2|Participant Flow|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
138586|NCT01794455|P1|Participant Flow|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
138587|NCT01794455|O2|Outcome|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
138588|NCT01794455|O1|Outcome|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
138589|NCT01794455|O2|Outcome|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
162182|NCT01704404|E6|Reported Event|Dose 6 TD-4208|"700 µg~TD-4208"
138592|NCT01794455|O1|Outcome|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
138593|NCT01794455|O2|Outcome|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
138594|NCT01794455|O1|Outcome|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
138595|NCT01794455|O2|Outcome|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
138596|NCT01794455|O1|Outcome|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
138597|NCT01794455|O2|Outcome|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
138598|NCT01794455|O1|Outcome|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
138599|NCT01794455|E2|Reported Event|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
138600|NCT01794455|E1|Reported Event|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
138601|NCT01794000|B3|Baseline|Total|Total of all reporting groups
138602|NCT01794000|B2|Baseline|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
138603|NCT01794000|B1|Baseline|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
138604|NCT01794000|P2|Participant Flow|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
138605|NCT01794000|P1|Participant Flow|Prasugrel|Participants (Pts.) will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
138606|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
138607|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
138608|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
138609|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
138610|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
138611|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
138612|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
138613|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
138614|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
138615|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
138616|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
138617|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
162183|NCT01704404|E5|Reported Event|Dose 5 TD-4208|"350 µg~TD-4208"
138618|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
138619|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
138620|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
138621|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
138622|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
138623|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
138624|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
138625|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
138626|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
138627|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
138628|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
138629|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
138630|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
138631|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
138632|NCT01794000|E3|Reported Event|Prasugrel - Open Label Phase|Participants who continued to meet eligibility criteria, who were not permanently discontinued from study drug, and who concluded their participation in 24 months of double blind treatment were to be considered eligible to enter the open label phase.
138633|NCT01794000|E2|Reported Event|Placebo - Double Blind Phase|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
138634|NCT01794000|E1|Reported Event|Prasugrel - Double Blind Phase|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
138635|NCT01793935|B3|Baseline|Total|Total of all reporting groups
138636|NCT01793935|B2|Baseline|Placebo|"Placebo~Placebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules."
138637|NCT01793935|B1|Baseline|Sensoril®|"Sensoril® is a proprietary extract of Withania Somnifera~Sensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera"
138638|NCT01793935|P2|Participant Flow|Placebo|"Placebo~Placebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules."
138639|NCT01793935|P1|Participant Flow|Sensoril®|"Sensoril® is a proprietary extract of Withania Somnifera~Sensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera"
138640|NCT01793935|O2|Outcome|Placebo|"Placebo~Placebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules."
138641|NCT01793935|O1|Outcome|Sensoril®|"Sensoril® is a proprietary extract of Withania Somnifera~Sensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera"
138642|NCT01793935|O2|Outcome|Placebo|"Placebo~Placebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules."
138643|NCT01793935|O1|Outcome|Sensoril®|"Sensoril® is a proprietary extract of Withania Somnifera~Sensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera"
138644|NCT01793935|O2|Outcome|Placebo|"Placebo~Placebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules."
138645|NCT01793935|O1|Outcome|Sensoril®|"Sensoril® is a proprietary extract of Withania Somnifera~Sensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera"
138646|NCT01793935|O2|Outcome|Placebo|"Placebo~Placebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules."
138647|NCT01793935|O1|Outcome|Sensoril®|"Sensoril® is a proprietary extract of Withania Somnifera~Sensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera"
138648|NCT01793935|O2|Outcome|Placebo|"Placebo~Placebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules."
138649|NCT01793935|O1|Outcome|Sensoril®|"Sensoril® is a proprietary extract of Withania Somnifera~Sensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera"
138650|NCT01793935|O2|Outcome|Placebo|"Placebo~Placebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules."
138651|NCT01793935|O1|Outcome|Sensoril®|"Sensoril® is a proprietary extract of Withania Somnifera~Sensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera"
138652|NCT01793935|O2|Outcome|Placebo|"Placebo~Placebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules."
138653|NCT01793935|O1|Outcome|Sensoril®|"Sensoril® is a proprietary extract of Withania Somnifera~Sensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera"
138654|NCT01793935|O2|Outcome|Placebo|"Placebo~Placebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules."
138655|NCT01793935|O1|Outcome|Sensoril®|"Sensoril® is a proprietary extract of Withania Somnifera~Sensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera"
138656|NCT01793935|O2|Outcome|Placebo|"Placebo~Placebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules."
138657|NCT01793935|O1|Outcome|Sensoril®|"Sensoril® is a proprietary extract of Withania Somnifera~Sensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera"
138658|NCT01793935|O2|Outcome|Placebo|"Placebo~Placebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules."
138659|NCT01793935|O1|Outcome|Sensoril®|"Sensoril® is a proprietary extract of Withania Somnifera~Sensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera"
138660|NCT01793935|O2|Outcome|Placebo|"Placebo~Placebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules."
138661|NCT01793935|O1|Outcome|Sensoril®|"Sensoril® is a proprietary extract of Withania Somnifera~Sensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera"
138662|NCT01793935|O2|Outcome|Placebo|"Placebo~Placebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules."
138663|NCT01793935|O1|Outcome|Sensoril®|"Sensoril® is a proprietary extract of Withania Somnifera~Sensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera"
138664|NCT01793935|O2|Outcome|Placebo|"Placebo~Placebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules."
138665|NCT01793935|O1|Outcome|Sensoril®|"Sensoril® is a proprietary extract of Withania Somnifera~Sensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera"
138666|NCT01793935|O2|Outcome|Placebo|"Placebo~Placebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules."
138667|NCT01793935|O1|Outcome|Sensoril®|"Sensoril® is a proprietary extract of Withania Somnifera~Sensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera"
138668|NCT01793935|O2|Outcome|Placebo|"Placebo~Placebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules."
138669|NCT01793935|O1|Outcome|Sensoril®|"Sensoril® is a proprietary extract of Withania Somnifera~Sensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera"
138670|NCT01793935|E2|Reported Event|Placebo|"Placebo~Placebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules."
138671|NCT01793935|E1|Reported Event|Sensoril®|"Sensoril® is a proprietary extract of Withania Somnifera~Sensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera"
138672|NCT01793883|B4|Baseline|Total|Total of all reporting groups
138673|NCT01793883|B3|Baseline|Placebo|"Matching Placebo~Placebo"
138674|NCT01793883|B2|Baseline|80 mg Laninamivir Octanoate DPI|"80 mg Laninamivir~80 mg Laninamivir Octanoate"
138675|NCT01793883|B1|Baseline|40 mg Laninamivir Octanoate DPI|"40 mg Laninamivir Octanoate and matching placebo~40 mg Laninamivir Octanoate~Placebo"
138676|NCT01793883|P3|Participant Flow|Placebo|"Matching Placebo~Placebo"
138677|NCT01793883|P2|Participant Flow|80 mg Laninamivir Octanoate DPI|"80 mg Laninamivir~80 mg Laninamivir Octanoate"
138678|NCT01793883|P1|Participant Flow|40 mg Laninamivir Octanoate DPI|"40 mg Laninamivir Octanoate and matching placebo~40 mg Laninamivir Octanoate~Placebo"
138679|NCT01793883|O3|Outcome|Placebo|"Matching Placebo~Placebo"
138680|NCT01793883|O2|Outcome|80 mg Laninamivir Octanoate DPI|"80 mg Laninamivir~80 mg Laninamivir Octanoate"
138681|NCT01793883|O1|Outcome|40 mg Laninamivir Octanoate DPI|"40 mg Laninamivir Octanoate and matching placebo~40 mg Laninamivir Octanoate~Placebo"
138682|NCT01793883|E3|Reported Event|Placebo|"Matching Placebo~Placebo"
138683|NCT01793883|E2|Reported Event|80 mg Laninamivir Octanoate DPI|"80 mg Laninamivir Octanoate~80 mg Laninamivir Octanoate"
138684|NCT01793883|E1|Reported Event|40 mg Laninamivir Octanoate DPI|"40 mg Laninamivir Octanoate and matching placebo~40 mg Laninamivir Octanoate~Placebo"
138685|NCT01793688|B1|Baseline|Sulbactam Sodium/Ampicillin Sodium|The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily).
138686|NCT01793688|P1|Participant Flow|Sulbactam Sodium/Ampicillin Sodium|The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily).
138687|NCT01793688|O1|Outcome|Sulbactam Sodium/Ampicillin Sodium|The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily).
138815|NCT01792518|O1|Outcome|Placebo|Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
138688|NCT01793688|O1|Outcome|Sulbactam Sodium/Ampicillin Sodium|The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily).
138689|NCT01793688|O1|Outcome|Sulbactam Sodium/Ampicillin Sodium|The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily).
138690|NCT01793688|O1|Outcome|Sulbactam Sodium/Ampicillin Sodium|The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily).
138691|NCT01793688|E1|Reported Event|Sulbactam Sodium/Ampicillin Sodium|The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily).
138692|NCT01793285|B1|Baseline|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
138693|NCT01793285|P1|Participant Flow|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 milligram (mg) weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
138694|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
138695|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
138696|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
138697|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
138698|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
138699|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
138700|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
138701|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
138702|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
138703|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
138704|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
138705|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
138706|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
138707|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
138708|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
138709|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
138930|NCT01791725|O1|Outcome|ELND005 BID|"ELND005 250 mg BID~ELND005"
138710|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
138711|NCT01793285|E1|Reported Event|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
138712|NCT01792986|B1|Baseline|Water-only 24-hour Fasting Once Per Week for 6 Weeks|
138713|NCT01792986|P1|Participant Flow|Water-only 24-hour Fasting Once Per Week for 6 Weeks|water-only 24-hour fasting once per week for 6 weeks
138714|NCT01792986|O1|Outcome|Water-only 24-hour Fasting Once Per Week for 6 Weeks|
138715|NCT01792986|O1|Outcome|Water-only 24-hour Fasting Once Per Week for 6 Weeks|
138716|NCT01792986|O1|Outcome|Water-only 24-hour Fasting Once Per Week for 6 Weeks|
138717|NCT01792986|O1|Outcome|Water-only 24-hour Fasting Once Per Week for 6 Weeks|
138718|NCT01792986|O1|Outcome|Water-only 24-hour Fasting Once Per Week for 6 Weeks|
138719|NCT01792986|E1|Reported Event|Water-only 24-hour Fasting Once Per Week for 6 Weeks|
138720|NCT01792830|B8|Baseline|Total|Total of all reporting groups
138721|NCT01792830|B7|Baseline|Diabetic/ Glargine and Glulisine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c >9% requiring subcutaneous insulin, will be discharged on basal bolus regimen at the same inpatient total daily insulin dose and glulisine before meals.
138722|NCT01792830|B6|Baseline|Diabetic/ Metformin and 80-Glargine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C >9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 80% of the total daily hospital dose or with a basal bolus regimen at the same inpatient total daily dose.
138723|NCT01792830|B5|Baseline|Diabetic/ Metformin and 50-Glargine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C between 7% and 9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 50% of the total daily hospital dose.
138724|NCT01792830|B4|Baseline|Diabetic/ Antidiabetic Regimen|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C <7% will be discharged on their same outpatient antidiabetic regimen.
138725|NCT01792830|B3|Baseline|No Diabetes/ Insulin|Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1C <7% and persistent hyperglycemia requiring subcutaneous insulin.
138726|NCT01792830|B2|Baseline|No Diabetes/ Metformin Only|Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1C <7% and persistent hyperglycemia requiring subcutaneous insulin, will be discharged on oral metformin.
138727|NCT01792830|B1|Baseline|Control|Subjects not requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1C level <7% not requiring subcutaneous insulin, will be discharged from the hospital without any antidiabetic therapy.
138728|NCT01792830|P7|Participant Flow|Diabetic/Glargine and Glulisine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c >9% requiring subcutaneous insulin, will be discharged on basal bolus regimen at the same inpatient total daily insulin dose and glulisine before meals.
138729|NCT01792830|P6|Participant Flow|Diabetic/ Metformin and 80-Glargine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c >9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 80% of the total daily hospital dose or with a basal bolus regimen at the same inpatient total daily dose.
138730|NCT01792830|P5|Participant Flow|Diabetic/ Metformin and 50-Glargine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c between 7% and 9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 50% of the total daily hospital dose.
138731|NCT01792830|P4|Participant Flow|Diabetic/ Antidiabetic Regimen|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c <7% will be discharged on their same outpatient antidiabetic regimen.
138732|NCT01792830|P3|Participant Flow|No Diabetes Insulin Group|Patients with an HbA1c < 7% and persistent hyperglycemia will be given subcutaneous (SC) insulin therapy in the hospital will be discharged on oral metformin.
138733|NCT01792830|P2|Participant Flow|No Diabetes/ Metformin Only|Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1c <7% and persistent hyperglycemia requiring subcutaneous insulin, will be discharged on oral metformin.
138734|NCT01792830|P1|Participant Flow|Control|Subjects not requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1c level <7% not requiring subcutaneous insulin, were discharged from the hospital without any antidiabetic therapy.
138735|NCT01792830|O10|Outcome|Diabetic HbA1C >9% Glulisine|Subjects requiring coronary artery bypass graft surgery with a history of diabetes with HbA1C between 7% and 9% requiring in hospital subcutaneous insulin will be discharged on glulisine, a rapid-acting insulin to be taken before meals.
138736|NCT01792830|O9|Outcome|Diabetic HbA1C >9% Metformin + IInsulin|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C > 9% will be discharged on oral metformin and glargine insulin to be taken daily at the same time of day; or, basal bolus insulin regimen.
138737|NCT01792830|O8|Outcome|Diabetic HbA1C 7%-9% Glargine|Patients with HbA1C between 7% and 9% requiring subcutaneous insulin therapy will be discharged on oral metformin and a single dose of glargine insulin at 50% of total daily hospital dose given once a day at the same time every day.
138738|NCT01792830|O7|Outcome|Diabetic HbA1C 7%-9% Metformin + Glargine|Patients treated with combination of oral antidiabetic agents and basal insulin (NPH, glargine, detemir) prior to admission will be discharged on pre-admission oral antidiabetic therapy plus a single dose of glargine insulin or with basal bolus insulin regimen at 50% of total daily hospital dose.
138739|NCT01792830|O6|Outcome|Diabetic HbA1C 7%- 9% Metformin|Subjects requiring coronary artery bypass graft surgery with a history of diabetes with HbA1C between 7% and 9% requiring in hospital subcutaneous insulin will be discharged on oral metformin and a single dose of glargine at 50% of total daily hospital dose. Metformin is given in divided doses with meals.
138740|NCT01792830|O5|Outcome|Diabetic HbA1C <7% Glargine|"Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C <7% will be discharged on their same outpatient antidiabetic regimen (diet, oral antidiabetic agents and/or insulin).~Metformin: Metformin is an oral antidiabetic agent used to control high blood glucose levels and is given in divided doses with meals. During treatment initiation and dose titration, the patient's blood glucose levels will be used to determine the therapeutic response to metformin and identify the minimum effective dose for the patient. Treatment naïve patients with an HbA1C between 7% and 9% prior to admission will be discharged on metformin monotherapy or a combination of metformin and a single dose of subcutaneous insulin."
138741|NCT01792830|O4|Outcome|Diabetic HbA1C <7% Metformin|"Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C <7% will be discharged on their same outpatient antidiabetic regimen (diet, oral antidiabetic agents and/or insulin).~Metformin: Metformin is an oral antidiabetic agent used to control high blood glucose levels and is given in divided doses with meals. During treatment initiation and dose titration, the patient's blood glucose levels will be used to determine the therapeutic response to metformin and identify the minimum effective dose for the patient.~Patients without a history of diabetes and admission HbA1C < 7% requiring SC insulin therapy in the hospital will be discharged on metformin monotherapy.~Treatment naïve patients with an HbA1C between 7% and 9% prior to admission will be discharged on metformin monotherapy or a combination of metformin and a single dose of subcutaneous insulin."
138742|NCT01792830|O3|Outcome|No Diabetes Insulin Group|Patients with an A1C < 7% and persistent hyperglycemia requiring SC insulin therapy in the hospital were discharged on oral metformin.
138743|NCT01792830|O2|Outcome|No Diabetes, Metformin Only|Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1C <7% and persistent hyperglycemia requiring subcutaneous insulin, will be discharged on oral metformin.
138744|NCT01792830|O1|Outcome|Control HbA1C < 7%|Subjects not requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1C <7% not requiring subcutaneous insulin in the hospital will be discharged on no antidiabetic therapy.
138745|NCT01792830|O10|Outcome|Diabetic HbA1C >9% Glulisine|Subjects requiring coronary artery bypass graft surgery with a history of diabetes with HbA1C between 7% and 9% requiring in hospital subcutaneous insulin were discharged on glulisine, a rapid-acting insulin taken before meals.
138746|NCT01792830|O9|Outcome|Diabetic HbA1C >9% Metformin + Insulin|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C > 9% were discharged on oral metformin and glargine insulin taken daily at the same time of day; or, basal bolus insulin regimen.
138747|NCT01792830|O8|Outcome|Diabetic HbA1C 7%-9% Glargine|Patients with HbA1C between 7% and 9% requiring subcutaneous insulin therapy were discharged on oral metformin and a single dose of glargine insulin at 50% of total daily hospital dose given once a day at the same time every day.
138748|NCT01792830|O7|Outcome|Diabetic HbA1C 7%-9% Metformin + Glargine|Patients treated with combination of oral antidiabetic agents and basal insulin (NPH, glargine, detemir) prior to admission were discharged on pre-admission oral antidiabetic therapy plus a single dose of glargine insulin or with basal bolus insulin regimen at 50% of total daily hospital dose.
138749|NCT01792830|O6|Outcome|Diabetic HbA1C 7%- 9% Metformin|Subjects requiring coronary artery bypass graft surgery with a history of diabetes with HbA1C between 7% and 9% requiring in hospital subcutaneous insulin were discharged on oral metformin and a single dose of glargine at 50% of total daily hospital dose. Metformin was given in divided doses with meals.
138750|NCT01792830|O5|Outcome|Diabetic HbA1C <7% Glargine|"Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C <7% were discharged on their same outpatient antidiabetic regimen (diet, oral antidiabetic agents and/or insulin).~During treatment initiation and dose titration, the patient's blood glucose levels were used to determine the therapeutic response to glargine and identify the minimum effective dose for the patient. Glargine is a long-acting basal insulin analogue, given once daily to help control the blood sugar levels."
138751|NCT01792830|O4|Outcome|Diabetic HbA1C <7% Metformin|"Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C <7% were discharged on their same outpatient antidiabetic regimen (diet, oral antidiabetic agents and/or insulin).~Metformin is an oral antidiabetic agent used to control high blood glucose levels and is given in divided doses with meals. During treatment initiation and dose titration, the patient's blood glucose levels were used to determine the therapeutic response to metformin and identify the minimum effective dose for the patient."
138752|NCT01792830|O3|Outcome|No Diabetes Insulin Group|Patients with an A1C < 7% and persistent hyperglycemia requiring SC insulin therapy in the hospital were discharged on oral metformin.
138753|NCT01792830|O2|Outcome|No Diabetes, Metformin Only|Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1C <7% were discharged on oral metformin.
138754|NCT01792830|O1|Outcome|Control HbA1C < 7%|Subjects not requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1C <7% not requiring subcutaneous insulin in the hospital were discharged on no antidiabetic therapy.
138755|NCT01792830|E6|Reported Event|Diabetic/ Glargine and Glulisine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c >9% requiring subcutaneous insulin, will be discharged on basal bolus regimen at the same inpatient total daily insulin dose and glulisine before meals.
138756|NCT01792830|E5|Reported Event|Diabetic/ Metformin and 80-Glargine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c >9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 80% of the total daily hospital dose or with a basal bolus regimen at the same inpatient total daily dose.
138757|NCT01792830|E4|Reported Event|Diabetic/ Metformin and 50-Glargine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c between 7% and 9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 50% of the total daily hospital dose.
138758|NCT01792830|E3|Reported Event|Diabetic/ Antidiabetic Regimen|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c <7% will be discharged on their same outpatient antidiabetic regimen.
138759|NCT01792830|E2|Reported Event|No Diabetes/ Metformin Only|Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1c <7% and persistent hyperglycemia requiring subcutaneous insulin, will be discharged on oral metformin.
138760|NCT01792830|E1|Reported Event|Control|Subjects not requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1c level <7% not requiring subcutaneous insulin, will be discharged from the hospital without any antidiabetic therapy.
138761|NCT01792817|B3|Baseline|Total|Total of all reporting groups
138762|NCT01792817|B2|Baseline|GammaCore Device|"Non-Invasive Vagus Nerve Stimulator~GammaCore: Treatment with active gammacore vagus nerve stimulator"
138763|NCT01792817|B1|Baseline|Sham GammaCore Device|"The Sham GammaCore device looks and operates like the Active GammaCore device, but does not deliver a therapeutic stimulation treatment.~Sham GammaCore device: Treatment with sham stimulator"
138764|NCT01792817|P3|Participant Flow|GammaCore Open Label|"Non-Invasive Vagus Nerve Stimulator~GammaCore: Treatment with active gammacore vagus nerve stimulator"
138765|NCT01792817|P2|Participant Flow|GammaCore Device|"Non-Invasive Vagus Nerve Stimulator~GammaCore: Treatment with active gammacore vagus nerve stimulator"
138766|NCT01792817|P1|Participant Flow|Sham GammaCore Device|"The Sham GammaCore device looks and operates like the Active GammaCore device, but does not deliver a therapeutic stimulation treatment.~Sham GammaCore device: Treatment with sham stimulator"
138767|NCT01792817|O2|Outcome|GammaCore Device|"Non-Invasive Vagus Nerve Stimulator~GammaCore: Treatment with active gammacore vagus nerve stimulator"
138768|NCT01792817|O1|Outcome|Sham GammaCore Device|"The Sham GammaCore device looks and operates like the Active GammaCore device, but does not deliver a therapeutic stimulation treatment.~Sham GammaCore device: Treatment with sham stimulator"
138769|NCT01792817|O2|Outcome|GammaCore Device|"Non-Invasive Vagus Nerve Stimulator~GammaCore: Treatment with active gammacore vagus nerve stimulator"
138770|NCT01792817|O1|Outcome|Sham GammaCore Device|"The Sham GammaCore device looks and operates like the Active GammaCore device, but does not deliver a therapeutic stimulation treatment.~Sham GammaCore device: Treatment with sham stimulator"
138771|NCT01792817|O2|Outcome|GammaCore Device|"Non-Invasive Vagus Nerve Stimulator~GammaCore: Treatment with active gammacore vagus nerve stimulator"
138772|NCT01792817|O1|Outcome|Sham GammaCore Device|"The Sham GammaCore device looks and operates like the Active GammaCore device, but does not deliver a therapeutic stimulation treatment.~Sham GammaCore device: Treatment with sham stimulator"
138773|NCT01792817|O2|Outcome|GammaCore Device|"Non-Invasive Vagus Nerve Stimulator~GammaCore: Treatment with active gammacore vagus nerve stimulator"
138774|NCT01792817|O1|Outcome|Sham GammaCore Device|"The Sham GammaCore device looks and operates like the Active GammaCore device, but does not deliver a therapeutic stimulation treatment.~Sham GammaCore device: Treatment with sham stimulator"
138775|NCT01792817|E3|Reported Event|GammaCore Device (Open Label Period)|"Non-Invasive Vagus Nerve Stimulator~GammaCore: Treatment with active gammacore vagus nerve stimulator"
138776|NCT01792817|E2|Reported Event|GammaCore Device (Randomized Period)|"Non-Invasive Vagus Nerve Stimulator~GammaCore: Treatment with active gammacore vagus nerve stimulator"
138777|NCT01792817|E1|Reported Event|Sham GammaCore Device (Randomized Period)|"The Sham GammaCore device looks and operates like the Active GammaCore device, but does not deliver a therapeutic stimulation treatment.~Sham GammaCore device: Treatment with sham stimulator"
138778|NCT01792635|B4|Baseline|Total|Total of all reporting groups
138779|NCT01792635|B3|Baseline|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
138780|NCT01792635|B2|Baseline|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
138781|NCT01792635|B1|Baseline|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
138782|NCT01792635|P3|Participant Flow|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
138783|NCT01792635|P2|Participant Flow|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
138784|NCT01792635|P1|Participant Flow|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
138785|NCT01792635|O1|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
138786|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
138787|NCT01792635|O1|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
138788|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
138789|NCT01792635|O1|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
138790|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
138791|NCT01792635|O2|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
138792|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
138793|NCT01792635|O2|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
138794|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
138795|NCT01792635|O2|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
138796|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
138797|NCT01792635|O2|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
138798|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
138799|NCT01792635|O1|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
138800|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
138801|NCT01792635|O1|Outcome|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
138802|NCT01792635|O1|Outcome|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
138803|NCT01792635|O1|Outcome|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
138804|NCT01792635|O1|Outcome|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
138805|NCT01792635|O1|Outcome|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
138806|NCT01792635|E3|Reported Event|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
138807|NCT01792635|E2|Reported Event|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
138808|NCT01792635|E1|Reported Event|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
138809|NCT01792518|B3|Baseline|Total|Total of all reporting groups
138810|NCT01792518|B2|Baseline|Linagliptin 5 mg|Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
138811|NCT01792518|B1|Baseline|Placebo|Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
138812|NCT01792518|P2|Participant Flow|Linagliptin 5 mg|Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
138813|NCT01792518|P1|Participant Flow|Placebo|Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
138814|NCT01792518|O2|Outcome|Linagliptin 5 mg|Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
138816|NCT01792518|O2|Outcome|Linagliptin 5 mg|Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
138817|NCT01792518|O1|Outcome|Placebo|Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
138818|NCT01792518|O2|Outcome|Linagliptin 5 mg|Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
138819|NCT01792518|O1|Outcome|Placebo|Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
138820|NCT01792518|E2|Reported Event|Linagliptin 5 mg|Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
138821|NCT01792518|E1|Reported Event|Placebo|Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
138822|NCT01792284|B1|Baseline|All Enrolled Participants|"Participants entered a 12-week Lead-in Period where they received fixed time of dose of LY2605541 with bolus insulin lispro. Participants were then randomized to either a fixed time of dose or a variable time of dose regimen for 12 weeks administered with bolus insulin lispro; after 12 weeks, they crossed over to the alternate regimen. LY2605541 dose was adjusted using a dosing algorithm based on the participant’s BG values and documented hypoglycemia during the previous week. Insulin dose were determined by insulin algorithms based on SMBG.~Fixed time of dose: Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks administered with bolus insulin lispro.~Variable time of dose: Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks administered with bolus insulin lispro."
138823|NCT01792284|P3|Participant Flow|LY2605541 Variable Time Dosing, LY2605541 Fixed Time Dosing|"Randomization Period 1: Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Participants were dosed in the morning on Monday, Wednesday, and Friday and in the evening on Tuesday, Thursday, Saturday, and Sunday. Dosing schedules were to remain approximately the same throughout the 12 weeks. Participant-specific dose of insulin lispro SQ when >20% of calories were consumed (pre-meal).~Randomization Period 2: Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks. Participant-specific dose of insulin lispro SQ when >20% of calories were consumed (pre-meal).~Insulin dose and adjustments to insulin dose were determined by insulin algorithms based on SMBG. Target glucose values were as follows:~Preprandial and bedtime BG between 71 and 130 mg/dL Insulin adjustment and glucose correction between 71 and 100 mg/dL."
138824|NCT01792284|P2|Participant Flow|LY2605541 Fixed Time Dosing, LY2605541 Variable Time Dosing|"Randomization Period 1: Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks. Participant-specific dose of insulin lispro SQ when >20% of calories were consumed (pre-meal).~Randomization Period 2: Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Participants were dosed in the morning on Monday, Wednesday, and Friday and in the evening on Tuesday, Thursday, Saturday, and Sunday. Dosing schedules were to remain approximately the same throughout the 12 weeks. Participant-specific dose of insulin lispro SQ when >20% of calories were consumed (pre-meal).~Insulin dose and adjustments to insulin dose were determined by insulin algorithms based on SMBG. Target glucose values were as follows:~Preprandial and bedtime BG between 71 and 130 mg/dL Insulin adjustment and glucose correction between 71 and 100 mg/dL."
138825|NCT01792284|P1|Participant Flow|LY2605541 Fixed Time Dosing (All Participants)|"Lead-in Period: Participant-specific dose of LY2605541 administered subcutaneously (SQ) at approximately the same time every evening for 12 weeks. Participant-specific dose of insulin lispro SQ when >20% of calories were consumed (pre-meal).~Insulin dose and adjustments to insulin dose were determined by insulin algorithms based on self-monitored blood glucose (SMBG).~Target glucose values were as follows:~Preprandial and bedtime BG between 71 and 130 milligrams/deciliter (mg/dL) Insulin adjustment and glucose correction between 71 and 100 mg/dL."
138826|NCT01792284|O2|Outcome|LY2605541 Variable Time Dosing|Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
138827|NCT01792284|O1|Outcome|LY2605541 Fixed Time Dosing|Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
138828|NCT01792284|O1|Outcome|All Participants|"All enrolled participants entered a 12-week lead-in period where they received fixed time dosing of LY2605541. Participants were then randomized to a fixed evening dose regimen or a variable time dose regimen for 12 weeks; after 12 weeks, they crossed over to the alternate regimen.~Fixed-time dose regimen: Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.~Variable-time dose regimen: Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks."
138829|NCT01792284|O2|Outcome|LY2605541 Variable Time Dosing|Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
138830|NCT01792284|O1|Outcome|LY2605541 Fixed Time Dosing|Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
138831|NCT01792284|O2|Outcome|LY2605541 Variable Time Dosing|Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
138832|NCT01792284|O1|Outcome|LY2605541 Fixed Time Dosing|Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
138833|NCT01792284|O2|Outcome|LY2605541 Variable Time Dosing|Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
138834|NCT01792284|O1|Outcome|LY2605541 Fixed Time Dosing|Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
138931|NCT01791725|O3|Outcome|Placebo|"Placebo BID~Placebo"
138835|NCT01792284|O1|Outcome|All Participants|"All enrolled participants entered a 12-week lead-in period where they received fixed time dosing of LY2605541. Participants were then randomized to a fixed evening dose regimen or a variable time dose regimen for 12 weeks; after 12 weeks, they crossed over to the alternate regimen.~Fixed-time dose regimen: Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.~Variable-time dose regimen: Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks."
138836|NCT01792284|O2|Outcome|LY2605541 Variable Time Dosing|Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
138837|NCT01792284|O1|Outcome|LY2605541 Fixed Time Dosing|Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
138838|NCT01792284|O1|Outcome|All Participants|"All enrolled participants entered a 12-week lead-in period where they received fixed time dosing of LY2605541. Participants were then randomized to a fixed evening dose regimen or a variable time dose regimen for 12 weeks; after 12 weeks, they crossed over to the alternate regimen.~Fixed-time dose regimen: Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.~Variable-time dose regimen: Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks."
138839|NCT01792284|O2|Outcome|LY2605541 Variable Time Dosing|Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
138840|NCT01792284|O1|Outcome|LY2605541 Fixed Time Dosing|Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
138841|NCT01792284|O2|Outcome|LY2605541 Variable Time Dosing|Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
138842|NCT01792284|O1|Outcome|LY2605541 Fixed Time Dosing|Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
138843|NCT01792284|O2|Outcome|LY2605541 Variable Time Dosing|Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
138844|NCT01792284|O1|Outcome|LY2605541 Fixed Time Dosing|Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
138845|NCT01792284|O2|Outcome|LY2605541 Variable Time Dosing|Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
138846|NCT01792284|O1|Outcome|LY2605541 Fixed Time Dosing|Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
138847|NCT01792284|O2|Outcome|LY2605541 Variable Time Dosing|Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
138848|NCT01792284|O1|Outcome|LY2605541 Fixed Time Dosing|Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
138849|NCT01792284|O2|Outcome|LY2605541 Variable Time Dosing|Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
138850|NCT01792284|O1|Outcome|LY2605541 Fixed Time Dosing|Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
138851|NCT01792284|O2|Outcome|LY2605541 Variable Time Dosing|Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
138852|NCT01792284|O1|Outcome|LY2605541 Fixed Time Dosing|Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
138853|NCT01792284|O2|Outcome|LY2605541 Variable Time Dosing|Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
138854|NCT01792284|O1|Outcome|LY2605541 Fixed Time Dosing|Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
138855|NCT01792284|O2|Outcome|LY2605541 Variable Time Dosing|Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
138856|NCT01792284|O1|Outcome|LY2605541 Fixed Time Dosing|Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
138857|NCT01792284|O2|Outcome|LY2605541 Variable Time Dosing|Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
138858|NCT01792284|O1|Outcome|LY2605541 Fixed Time Dosing|Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
138859|NCT01792284|E3|Reported Event|LY2605541 Variable Time Dosing, LY2605541 Fixed Time Dosing|"Randomization Period 1: Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Participants were dosed in the morning on Monday, Wednesday, and Friday and in the evening on Tuesday, Thursday, Saturday, and Sunday. Dosing schedules were to remain approximately the same throughout the 12 weeks. Participant-specific dose of insulin lispro SQ when >20% of calories were consumed (pre-meal).~Randomization Period 2: Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks. Participant-specific dose of insulin lispro SQ when >20% of calories were consumed (pre-meal).~Insulin dose and adjustments to insulin dose were determined by insulin algorithms based on SMBG. Target glucose values were as follows:~Preprandial and bedtime BG between 71 and 130 mg/dL Insulin adjustment and glucose correction between 71 and 100 mg/dL."
138860|NCT01792284|E2|Reported Event|LY2605541 Fixed Time Dosing, LY2605541 Variable Time Dosing|"Randomization Period 1: Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks. Participant-specific dose of insulin lispro SQ when >20% of calories were consumed (pre-meal).~Randomization Period 2: Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Participants were dosed in the morning on Monday, Wednesday, and Friday and in the evening on Tuesday, Thursday, Saturday, and Sunday. Dosing schedules were to remain approximately the same throughout the 12 weeks. Participant-specific dose of insulin lispro SQ when >20% of calories were consumed (pre-meal).~Insulin dose and adjustments to insulin dose were determined by insulin algorithms based on SMBG. Target glucose values were as follows:~Preprandial and bedtime BG between 71 and 130 mg/dL Insulin adjustment and glucose correction between 71 and 100 mg/dL."
138861|NCT01792284|E1|Reported Event|LY2605541 (All Participants)|All participants who received at least 1 dose of LY2605541 during the Lead-In Period, Randomization Period 1, and Randomization Period 2.
138862|NCT01792024|B1|Baseline|Treatment (LITT)|"Patients undergo MR-guided laser ablation of prostate cancer~Visualase Thermal Therapy: MR guided laser ablation of prostate cancer~magnetic resonance imaging: Undergo MR-guided LITT"
138863|NCT01792024|P1|Participant Flow|Treatment (LITT)|"Patients undergo MR-guided laser ablation of prostate cancer~Visualase Thermal Therapy: MR guided laser ablation of prostate cancer~magnetic resonance imaging: Undergo MR-guided LITT"
138864|NCT01792024|O1|Outcome|Treatment (LITT)|"Patients undergo MR-guided laser ablation of prostate cancer~Visualase Thermal Therapy: MR guided laser ablation of prostate cancer~magnetic resonance imaging: Undergo MR-guided LITT"
138865|NCT01792024|O1|Outcome|Treatment (LITT)|"Patients undergo MR-guided laser ablation of prostate cancer~Visualase Thermal Therapy: MR guided laser ablation of prostate cancer~magnetic resonance imaging: Undergo MR-guided LITT"
138866|NCT01792024|O1|Outcome|Treatment (LITT)|"Patients undergo MR-guided laser ablation of prostate cancer~Visualase Thermal Therapy: MR guided laser ablation of prostate cancer~magnetic resonance imaging: Undergo MR-guided LITT"
138867|NCT01792024|O1|Outcome|Treatment (LITT)|"Patients undergo MR-guided laser ablation of prostate cancer~Visualase Thermal Therapy: MR guided laser ablation of prostate cancer~magnetic resonance imaging: Undergo MR-guided LITT"
138868|NCT01792024|O1|Outcome|Treatment (LITT)|"Patients undergo MR-guided laser ablation of prostate cancer~Visualase Thermal Therapy: MR guided laser ablation of prostate cancer~magnetic resonance imaging: Undergo MR-guided LITT"
138869|NCT01792024|E1|Reported Event|Treatment (LITT)|"Patients undergo MR-guided laser ablation of prostate cancer~Visualase Thermal Therapy: MR guided laser ablation of prostate cancer~magnetic resonance imaging: Undergo MR-guided LITT"
138870|NCT01791972|B3|Baseline|Total|Total of all reporting groups
138871|NCT01791972|B2|Baseline|Placebo Spiromax / Albuterol Spiromax|Placebo Spiromax, (2 inhalations), single dose on Day 1. Albuterol Spiromax 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on approximately Day 7.
138872|NCT01791972|B1|Baseline|Albuterol Spiromax / Placebo Spiromax|Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on Day 1. Placebo Spiromax (2 inhalations), single dose on approximately Day 7.
138873|NCT01791972|P2|Participant Flow|Placebo Spiromax / Albuterol Spiromax|Placebo Spiromax, (2 inhalations), single dose on Day 1. Albuterol Spiromax 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on approximately Day 7.
138874|NCT01791972|P1|Participant Flow|Albuterol Spiromax / Placebo Spiromax|Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on Day 1. Placebo Spiromax (2 inhalations), single dose on approximately Day 7.
138875|NCT01791972|O2|Outcome|Placebo Spiromax|Single dose of Placebo Spiromax (2 inhalations)
138876|NCT01791972|O1|Outcome|Albuterol Spiromax 180 mcg|Single dose of Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation)
138877|NCT01791972|O2|Outcome|Placebo Spiromax|Single dose of Placebo Spiromax (2 inhalations)
138878|NCT01791972|O1|Outcome|Albuterol Spiromax 180 mcg|Single dose of Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation)
138879|NCT01791972|O2|Outcome|Placebo Spiromax|Single dose of Placebo Spiromax (2 inhalations)
138880|NCT01791972|O1|Outcome|Albuterol Spiromax 180 mcg|Single dose of Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation)
138881|NCT01791972|E2|Reported Event|Placebo Spiromax|Single dose of Placebo Spiromax (2 inhalations)
138882|NCT01791972|E1|Reported Event|Albuterol Spiromax 180 mcg|Single dose of Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation)
138883|NCT01791894|B1|Baseline|Treatment (Arsenic Trioxide)|arsenic trioxide IV over 2 hours on days 1-5. Courses repeat every 28 days
138884|NCT01791894|P1|Participant Flow|IV ATO|5 subjects will be treated with arsenic trioxide at 0.3 mg/kg daily via a 2 hour intravenous infusion for 5 days every 28 days (+/- 5 days) for a total of 3 cycles.
138885|NCT01791894|O1|Outcome|IV ATO|5 subjects will be treated with arsenic trioxide at 0.3 mg/kg daily via a 2 hour intravenous infusion for 5 days every 28 days (+/- 5 days) for a total of 3 cycles.
138886|NCT01791894|O1|Outcome|IV ATO|5 subjects will be treated with arsenic trioxide at 0.3 mg/kg daily via a 2 hour intravenous infusion for 5 days every 28 days (+/- 5 days) for a total of 3 cycles.
138887|NCT01791894|O1|Outcome|Treatment (Arsenic Trioxide)|"Patients receive arsenic trioxide IV over 2 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~arsenic trioxide: Given IV~laboratory biomarker analysis: Correlative studies"
138888|NCT01791894|O1|Outcome|Treatment (Arsenic Trioxide)|"Patients receive arsenic trioxide IV over 2 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~arsenic trioxide: Given IV~laboratory biomarker analysis: Correlative studies"
138889|NCT01791894|E1|Reported Event|Treatment (Arsenic Trioxide)|"Patients receive arsenic trioxide IV over 2 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~arsenic trioxide: Given IV"
138890|NCT01791803|B5|Baseline|Total|Total of all reporting groups
138891|NCT01791803|B4|Baseline|Self-Quit Group|Patients were given brief counseling during hospitalization and were not contacted until 26 weeks after hospitalization. They received no telephone contact and or counseling after discharge.
138932|NCT01791725|O2|Outcome|ELND005 QD|"ELND005 250 mg QD~ELND005"
138933|NCT01791725|O1|Outcome|ELND005 BID|"ELND005 250 mg BID~ELND005"
138892|NCT01791803|B3|Baseline|Hypnotherapy and Nicotine Replacement|patients recieved both a similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nictotine replacement supplies for a month after discharge.
138893|NCT01791803|B2|Baseline|Nicotine Replacement Therapy|Patients received a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays, self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization.
138894|NCT01791803|B1|Baseline|Hypnotherapy|Patients received a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use . They also received counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge.
138895|NCT01791803|P4|Participant Flow|Self-Quit Group|patients will be given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization.
138896|NCT01791803|P3|Participant Flow|Hypnotherapy and Nicotine Replacement|"The group will recieve similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nictotine replacement supplies for a month after discharge.~hypnotherapy: One 90 minute session within 2 weeks of hospital discharge~Nicotine: free one month supply after hospital discharge"
138897|NCT01791803|P2|Participant Flow|Nicotine Replacement Therapy|"Patients will recieve a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays. Patients will receive self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization.~Nicotine: free one month supply after hospital discharge"
138898|NCT01791803|P1|Participant Flow|Hypnotherapy|"Patients admitted with a cardiopulmonary illness will receive a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use after the session. They will also recieve self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge.~hypnotherapy: One 90 minute session within 2 weeks of hospital discharge"
138899|NCT01791803|O1|Outcome|Smoking Abstinence Rates at 12 and 26 Weeks|Smoking status at follow-up time at 12 and 26 weeks by diagnosis status (cardiac vs. pulmonary)
138900|NCT01791803|O4|Outcome|Self-Quit Group|patients were given brief counseling during hospitalization and were not be contacted until 26 weeks after hospitalization.
138901|NCT01791803|O3|Outcome|Hypnotherapy and Nicotine Replacement|"The group received similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nicotine replacement supplies for a month after discharge.~hypnotherapy: One 90 minute session within 2 weeks of hospital discharge~Nicotine: free one month supply after hospital discharge"
138902|NCT01791803|O2|Outcome|Nicotine Replacement Therapy|"Patients received a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays. Patients also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization.~Nicotine: free one month supply after hospital discharge"
138903|NCT01791803|O1|Outcome|Hypnotherapy|"Patients admitted with a cardiopulmonary illness received a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use after the session. They will also recieve self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge.~hypnotherapy: One 90 minute session within 2 weeks of hospital discharge"
138904|NCT01791803|O4|Outcome|Self-Quit Group|patients were given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization.
138905|NCT01791803|O3|Outcome|Hypnotherapy and Nicotine Replacement|"The group received similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nicotine replacement supplies for a month after discharge.~hypnotherapy: One 90 minute session within 2 weeks of hospital discharge~Nicotine: free one month supply after hospital discharge"
138906|NCT01791803|O2|Outcome|Nicotine Replacement Therapy|"Patients received a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays. Patients also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization.~Nicotine: free one month supply after hospital discharge"
138907|NCT01791803|O1|Outcome|Hypnotherapy|"Patients admitted with a cardiopulmonary illness received a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use after the session. They also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge.~hypnotherapy: One 90 minute session within 2 weeks of hospital discharge"
138908|NCT01791803|E4|Reported Event|Self-Quit Group|patient who decided to quit on their own
138909|NCT01791803|E3|Reported Event|Hypnotherapy and Nicotine Replacement|Patients receiving hypnotherapy and nicotine supply
138910|NCT01791803|E2|Reported Event|Nicotine Replacement Therapy|Patients receiving a free months supply of nicotine
138911|NCT01791803|E1|Reported Event|Hypnotherapy|patients receiving a free intensive session of hypnotherapy within 2 weeks of hospitalization
138912|NCT01791725|B4|Baseline|Total|Total of all reporting groups
138913|NCT01791725|B3|Baseline|Placebo|"Placebo BID~Placebo"
138914|NCT01791725|B2|Baseline|ELND005 QD|"ELND005 250 mg QD~ELND005"
138915|NCT01791725|B1|Baseline|ELND005 BID|"ELND005 250 mg BID~ELND005"
138916|NCT01791725|P3|Participant Flow|Placebo|"Placebo BID~Placebo"
138917|NCT01791725|P2|Participant Flow|ELND005 QD|"ELND005 250 mg QD~ELND005"
138918|NCT01791725|P1|Participant Flow|ELND005 BID|"ELND005 250 mg BID~ELND005"
138919|NCT01791725|O3|Outcome|Placebo|"Placebo BID~Placebo"
138920|NCT01791725|O2|Outcome|ELND005 QD|"ELND005 250 mg QD~ELND005"
138921|NCT01791725|O1|Outcome|ELND005 BID|"ELND005 250 mg BID~ELND005"
138922|NCT01791725|O3|Outcome|Placebo|"Placebo BID~Placebo"
138923|NCT01791725|O2|Outcome|ELND005 QD|"ELND005 250 mg QD~ELND005"
138924|NCT01791725|O1|Outcome|ELND005 BID|"ELND005 250 mg BID~ELND005"
138925|NCT01791725|O3|Outcome|Placebo|"Placebo BID~Placebo"
138926|NCT01791725|O2|Outcome|ELND005 QD|"ELND005 250 mg QD~ELND005"
138927|NCT01791725|O1|Outcome|ELND005 BID|"ELND005 250 mg BID~ELND005"
138928|NCT01791725|O3|Outcome|Placebo|"Placebo BID~Placebo"
138929|NCT01791725|O2|Outcome|ELND005 QD|"ELND005 250 mg QD~ELND005"
138938|NCT01791517|B3|Baseline|Senofilcon A|All subjects that were randomized to the study lens senofilcon A and 1 of 12 possible solution sequences.
138939|NCT01791517|B2|Baseline|Galyfilcon A|All subjects that were randomized to the study lens galyfilcon A and 1 of 12 possible solution sequences.
138940|NCT01791517|B1|Baseline|Etafilcon A|All subjects that were randomized to the study lens etafilcon A and 1 of 12 possible solution sequences.
138941|NCT01791517|P12|Participant Flow|Clear Care/RevitaLens/PureMoist/Biotrue|Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
138942|NCT01791517|P11|Participant Flow|Clear Care/PureMoist/Biotrue/RevitaLens|Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
138943|NCT01791517|P10|Participant Flow|Clear Care/Biotrue/RevitaLens/PureMoist|Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
138944|NCT01791517|P9|Participant Flow|RevitaLens/Clear Care/Biotrue/PureMoist|Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
138945|NCT01791517|P8|Participant Flow|RevitaLens/PureMoist/Clear Care/Biotrue|Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
138946|NCT01791517|P7|Participant Flow|RevitaLens/Biotrue/PureMoist/Clear Care|Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
138947|NCT01791517|P6|Participant Flow|PureMoist/Clear Care/RevitaLens/Biotrue|Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
138948|NCT01791517|P5|Participant Flow|PureMoist/RevitaLens/Biotrue/Clear Care|Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
138949|NCT01791517|P4|Participant Flow|PureMoist/Biotrue/Clear Care/RevitaLens|Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
138950|NCT01791517|P3|Participant Flow|Biotrue/Clear Care/PureMoist/RevitaLens|Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
138951|NCT01791517|P2|Participant Flow|Biotrue/RevitaLens/Clear Care/PureMoist|Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
138952|NCT01791517|P1|Participant Flow|Biotrue/PureMoist/Revitalens/Clear Care|Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
138953|NCT01791517|O4|Outcome|Solution 4(Clear Care)|Subjects that received solution 4 during any of the 4 study periods.
138954|NCT01791517|O3|Outcome|Solution 3(Biotrue)|Subjects that received solution 3 during any of the 4 study periods.
138955|NCT01791517|O2|Outcome|Solution 2(PureMoist)|Subjects that received solution 2 during any of the 4 study periods.
138956|NCT01791517|O1|Outcome|Solution 1(RevitaLens)|Subjects that received solution 1 during any of the 4 study periods.
138957|NCT01791517|O4|Outcome|Solution 4(Clear Care)|Subjects that received solution 4 during any of the 4 study periods.
138958|NCT01791517|O3|Outcome|Solution 3(Biotrue)|Subjects that received solution 3 during any of the 4 study periods.
138959|NCT01791517|O2|Outcome|Solution 2(PureMoist)|Subjects that received solution 2 during any of the 4 study periods.
138960|NCT01791517|O1|Outcome|Solution 1(RevitaLens)|Subjects that received solution 1 during any of the 4 study periods.
138961|NCT01791517|O4|Outcome|Solution 4(Clear Care)|Subjects that received solution 4 during any of the 4 study periods.
138962|NCT01791517|O3|Outcome|Solution 3(Biotrue)|Subjects that received solution 3 during any of the 4 study periods.
138963|NCT01791517|O2|Outcome|Solution 2(PureMoist)|Subjects that received solution 2 during any of the 4 study periods.
138964|NCT01791517|O1|Outcome|Solution 1(RevitaLens)|Subjects that received solution 1 during any of the 4 study periods.
138965|NCT01791517|E12|Reported Event|Solution 4(Clear Care): Etafilcon A|Subjects that were randomized to the etafilcon A lens and received solution 4 during any of the 4 study periods.
138966|NCT01791517|E11|Reported Event|Solution 4(Clear Care): Galyfilcon A|Subjects that were randomized to the galyfilcon A lens and received solution 4 during any of the 4 study periods.
138967|NCT01791517|E10|Reported Event|Solution 4(Clear Care): Senofilcon A|Subjects that were randomized to the senofilcon A lens and received solution 4 during any of the 4 study periods.
138968|NCT01791517|E9|Reported Event|Solution 3(Biotrue): Etafilcon A|Subjects that were randomized to the etafilcon A lens and received solution 3 during any of the 4 study periods.
138969|NCT01791517|E8|Reported Event|Solution 3(Biotrue): Galyfilcon A|Subjects that were randomized to the galyfilcon A lens and received solution 3 during any of the 4 study periods.
138970|NCT01791517|E7|Reported Event|Solution 3(Biotrue): Senofilcon A|Subjects that were randomized to the senofilcon A lens and received solution 3 during any of the 4 study periods.
138971|NCT01791517|E6|Reported Event|Solution 2(PureMoist): Etafilcon A|Subjects were randomized to the etafilcon A lens and that received solution 2 during any of the 4 study periods.
138972|NCT01791517|E5|Reported Event|Solution 2(PureMoist): Galyfilcon A|Subjects were randomized to the galyfilcon A lens and that received solution 2 during any of the 4 study periods.
138973|NCT01791517|E4|Reported Event|Solution 2(PureMoist):Senofilcon A|Subjects were randomized to the senofilcon A lens and that received solution 2 during any of the 4 study periods.
138974|NCT01791517|E3|Reported Event|Solution 1(RevitaLens): Etafilcon A|Subjects that were randomized to the etafilcon A lens and received solution 1 during any of the 4 study periods.
138975|NCT01791517|E2|Reported Event|Solution 1 (RevitaLens): Galyfilcon A|Subjects that were randomized to the galyfilcon A lens and received solution 1 during any of the 4 study periods.
139708|NCT01788163|O2|Outcome|EGFR Mutation Negative|Participants who were EGFR Mutation Negative for the analysis population.
138976|NCT01791517|E1|Reported Event|Solution 1(RevitaLens): Senofilcon A|Subjects that were randomized to the senofilcon A lens and received solution 1 during any of the 4 study periods.
138977|NCT01791491|B1|Baseline|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
138978|NCT01791491|P1|Participant Flow|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
138979|NCT01791491|O1|Outcome|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
138980|NCT01791491|O1|Outcome|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
138981|NCT01791491|O1|Outcome|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
138982|NCT01791491|O1|Outcome|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
138983|NCT01791491|O1|Outcome|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
138984|NCT01791491|O1|Outcome|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
138985|NCT01791491|O1|Outcome|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
138986|NCT01791491|O1|Outcome|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
138987|NCT01791491|O1|Outcome|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
138988|NCT01791491|E1|Reported Event|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
138989|NCT01791465|B1|Baseline|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide
138990|NCT01791465|P1|Participant Flow|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
138991|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
138992|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
138993|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
138994|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
138995|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
138996|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
138997|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
138998|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
138999|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
139000|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
139001|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
139002|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
139003|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
139004|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
139005|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
139006|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
139007|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
139008|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
139009|NCT01791465|O1|Outcome|Bydureon Treatment|"Treatment for 16 weeks with extended-release Exenatide (Bydureon)~extended-release exenatide: Single arm study - 2mg Bydureon every 7 days x 16 weeks"
139010|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
139011|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
139012|NCT01791465|E1|Reported Event|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
139013|NCT01791413|B3|Baseline|Total|Total of all reporting groups
139014|NCT01791413|B2|Baseline|Depot Medroxyprogesterone Acetate|depot medroxyprogesterone acetate : DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)
139015|NCT01791413|B1|Baseline|No Depot Medroxyprogesterone Acetate|
139016|NCT01791413|P2|Participant Flow|Depot Medroxyprogesterone Acetate|depot medroxyprogesterone acetate : DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)
139017|NCT01791413|P1|Participant Flow|No Depot Medroxyprogesterone Acetate|
139018|NCT01791413|O4|Outcome|3 mo. Post op: Depot Medroxyprogesterone Acetate|Percentage changes of serum Anti-Mullerian hormone (AMH) at 3-month post operation
139815|NCT01788163|O5|Outcome|Thailand|Subjects in Thailand that meet I/E and population criteria
139019|NCT01791413|O3|Outcome|3 mo. Post op: No Depot Medroxyprogesterone Acetate|Percentage changes of serum Anti-Mullerian hormone (AMH) at 3-month post operation
139020|NCT01791413|O2|Outcome|2 wk Post op:Depot Medroxyprogesterone Acetate|depot medroxyprogesterone acetate : DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)Percentage changes of serum Anti-Mullerian hormone (AMH) at 2-week post operation
139021|NCT01791413|O1|Outcome|2 wk Post op : No Depot Medroxyprogesterone Acetate|Percentage changes of serum Anti-Mullerian hormone (AMH) at 2-week post operation
139022|NCT01791413|E1|Reported Event|DMPA|
139023|NCT01791244|B3|Baseline|Total|Total of all reporting groups
139024|NCT01791244|B2|Baseline|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
139025|NCT01791244|B1|Baseline|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
139026|NCT01791244|P2|Participant Flow|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
139027|NCT01791244|P1|Participant Flow|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 microgram (mcg) subcutaneously (SC) 3 times a week in accordance to the summary of product characteristics (SPC) along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
139028|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
139029|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
139030|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
139031|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
139032|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
139033|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
139034|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
139035|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
139036|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
139037|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
139038|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
139039|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
139040|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
139041|NCT01791244|O1|Outcome|Patient Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
139042|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
139043|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 microgram (mcg) subcutaneously (SC) 3 times a week in accordance to the summary of product characteristics (SPC) along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
139044|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
139045|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
139046|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
139047|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
139048|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
139049|NCT01791244|O1|Outcome|Patient Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
139050|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
139051|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
139052|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
139053|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
139054|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
139055|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
139056|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
139057|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
139058|NCT01791244|E2|Reported Event|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
139059|NCT01791244|E1|Reported Event|Patient Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
139060|NCT01791205|B3|Baseline|Total|Total of all reporting groups
139061|NCT01791205|B2|Baseline|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
139062|NCT01791205|B1|Baseline|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139063|NCT01791205|P2|Participant Flow|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
139160|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
139816|NCT01788163|O4|Outcome|Australia|Subjects in Australia that meet I/E and population criteria
139064|NCT01791205|P1|Participant Flow|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received tocilizumab (TCZ) as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139065|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139066|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139067|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139068|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139069|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139070|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139071|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139072|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139073|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139074|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139075|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139076|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139077|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139078|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139079|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139228|NCT01790828|E1|Reported Event|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
139080|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139081|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139082|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139083|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139084|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139085|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
139086|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139087|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
139088|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139089|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
139090|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139091|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
139092|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139093|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
139094|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139095|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
139096|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139097|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
139098|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139099|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
139695|NCT01788163|O2|Outcome|China-Mutation Status Negative|Subjects in China that meet I/E and population criteria, who had a Negative Mutation Status.
162184|NCT01704404|E4|Reported Event|Dose 4 TD-4208|"175 µg~TD-4208"
139100|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139101|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
139102|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139103|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
139104|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139105|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139106|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
139107|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139108|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
139109|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139110|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
139111|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139112|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
139113|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139114|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139115|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139116|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139117|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
139118|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139119|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
139229|NCT01790750|B1|Baseline|PES First, Then FFES|A 5-minute Pocket echocardiography system scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
139120|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139121|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139122|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
139123|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139124|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
139125|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139126|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
139127|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139128|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
139129|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139130|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
139131|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139132|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
139133|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139134|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
139135|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139136|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
139137|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139138|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
139139|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139140|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
139141|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139142|NCT01791205|E1|Reported Event|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
139143|NCT01791153|B5|Baseline|Total|Total of all reporting groups
139144|NCT01791153|B4|Baseline|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
139145|NCT01791153|B3|Baseline|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139146|NCT01791153|B2|Baseline|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139147|NCT01791153|B1|Baseline|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139148|NCT01791153|P4|Participant Flow|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
139149|NCT01791153|P3|Participant Flow|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139150|NCT01791153|P2|Participant Flow|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection every 2 weeks (q2w) (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139151|NCT01791153|P1|Participant Flow|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 milligrams (mg) as subcutaneous (SC) injection every week (qw) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139152|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
139153|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139154|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139155|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139156|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
139157|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139158|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139159|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139380|NCT01790490|O3|Outcome|Lorazepam Infusion 2 mg/kg Over 52 Minutes (LZP) Following K1|Infusions are separated by 48 hours. This allows for within-subject comparison of the post-K1 additive effects of K2 and LZP.
139161|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139162|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139163|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139164|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
139165|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139166|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139167|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139168|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
139169|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139170|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139171|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139172|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139173|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139174|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139175|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139176|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139177|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139178|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139381|NCT01790490|O2|Outcome|Lorazepam Infusion 2 mg/kg Over 52 Minutes (LZP)|LZP followed by K1 and then K2. Infusions are separated by 48 hours. This order allows for comparison between LZP and K1.
139179|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139180|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
139181|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139182|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139183|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139184|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
139185|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139186|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139187|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139188|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
139189|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139190|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139191|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139192|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
139193|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139194|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139195|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139196|NCT01791153|O3|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
139197|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139696|NCT01788163|O1|Outcome|China-Mutation Status Positive|Subjects in China that meet I/E and population criteria, who had a Positive Mutation Status.
139198|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139199|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139200|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139201|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139202|NCT01791153|E4|Reported Event|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
139203|NCT01791153|E3|Reported Event|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139204|NCT01791153|E2|Reported Event|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139205|NCT01791153|E1|Reported Event|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
139206|NCT01790828|B1|Baseline|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
139207|NCT01790828|P1|Participant Flow|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
139208|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
139209|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
139210|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
139211|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
139212|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
139213|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
139214|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
139215|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
139216|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
139217|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
139218|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
139219|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
139220|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
139221|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
139222|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
139223|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
139224|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
139225|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
139226|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
139227|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
139230|NCT01790750|P1|Participant Flow|PES First, Then FFES|A 5-minute Pocket echocardiography system scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
139231|NCT01790750|O1|Outcome|PES First, Then FFES|A 5-minute Pocket Echocardiography System Scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
139232|NCT01790750|O1|Outcome|PES First, Then FFES|A 5-minutePocket Echocardiography System Scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
139233|NCT01790750|E1|Reported Event|PES First, Then FFES|A 5-minute Pocket Echocardiography System Scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
139234|NCT01790685|B3|Baseline|Total|Total of all reporting groups
139235|NCT01790685|B2|Baseline|BRVO|"Branch Retinal Vein Occlusion~dexamethasone implant"
139236|NCT01790685|B1|Baseline|CRVO|"Central Retinal Vein Occlusion~dexamethasone implant"
139237|NCT01790685|P2|Participant Flow|BRVO|"Branch Retinal Vein Occlusion~dexamethasone implant"
139238|NCT01790685|P1|Participant Flow|CRVO|"Central Retinal Vein Occlusion~dexamethasone implant"
139239|NCT01790685|O2|Outcome|BRVO|"Branch Retinal Vein Occlusion~dexamethasone implant"
139240|NCT01790685|O1|Outcome|CRVO|"Central Retinal Vein Occlusion~dexamethasone implant"
139241|NCT01790685|E2|Reported Event|BRVO|"Branch Retinal Vein Occlusion~dexamethasone implant"
139242|NCT01790685|E1|Reported Event|CRVO|"Central Retinal Vein Occlusion~dexamethasone implant"
139243|NCT01790659|B3|Baseline|Total|Total of all reporting groups
139244|NCT01790659|B2|Baseline|Paromomycin|"Paromomycin alone~Paromomycin: Paromomycin alone"
139245|NCT01790659|B1|Baseline|WR 279,396|"(Paromomycin and Gentamicin Topical Cream)~WR 279,396: WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%"
139246|NCT01790659|P2|Participant Flow|Paromomycin|"Paromomycin alone~Paromomycin: Paromomycin alone"
139247|NCT01790659|P1|Participant Flow|WR 279,396|"(Paromomycin and Gentamicin Topical Cream)~WR 279,396: WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%"
139248|NCT01790659|O2|Outcome|Paromomycin|"Paromomycin alone~Paromomycin: Paromomycin alone"
139249|NCT01790659|O1|Outcome|WR 279,396|"(Paromomycin and Gentamicin Topical Cream)~WR 279,396: WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%"
139250|NCT01790659|O2|Outcome|Paromomycin|"Paromomycin alone~Paromomycin: Paromomycin alone"
139251|NCT01790659|O1|Outcome|WR 279,396|"(Paromomycin and Gentamicin Topical Cream)~WR 279,396: WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%"
139252|NCT01790659|O2|Outcome|Paromomycin|"Paromomycin alone~Paromomycin: Paromomycin alone"
139253|NCT01790659|O1|Outcome|WR 279,396|"(Paromomycin and Gentamicin Topical Cream)~WR 279,396: WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%"
139254|NCT01790659|O2|Outcome|Paromomycin|"Paromomycin alone~Paromomycin: Paromomycin alone"
139255|NCT01790659|O1|Outcome|WR 279,396|"(Paromomycin and Gentamicin Topical Cream)~WR 279,396: WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%"
139256|NCT01790659|O2|Outcome|Paromomycin|"Paromomycin alone~Paromomycin: Paromomycin alone"
139257|NCT01790659|O1|Outcome|WR 279,396|"(Paromomycin and Gentamicin Topical Cream)~WR 279,396: WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%"
139258|NCT01790659|O2|Outcome|Paromomycin|"Paromomycin alone~Paromomycin: Paromomycin alone"
139259|NCT01790659|O1|Outcome|WR 279,396|"(Paromomycin and Gentamicin Topical Cream)~WR 279,396: WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%"
139260|NCT01790659|E2|Reported Event|Paromomycin|"Paromomycin alone~Paromomycin: Paromomycin alone"
139261|NCT01790659|E1|Reported Event|WR 279,396|"(Paromomycin and Gentamicin Topical Cream)~WR 279,396: WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%"
139262|NCT01790633|B3|Baseline|Total|Total of all reporting groups
139263|NCT01790633|B2|Baseline|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test~Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
139264|NCT01790633|B1|Baseline|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).~ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
139265|NCT01790633|P2|Participant Flow|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test~Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
139266|NCT01790633|P1|Participant Flow|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).~ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
139267|NCT01790633|O2|Outcome|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test~Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
139268|NCT01790633|O1|Outcome|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).~ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
139269|NCT01790633|O1|Outcome|Screened for Eligibility|Individuals who were screened for eligibility, prior to being considered for randomization.
139697|NCT01788163|O9|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
139270|NCT01790633|O2|Outcome|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test~Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
139271|NCT01790633|O1|Outcome|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).~ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
139272|NCT01790633|O2|Outcome|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test~Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
139273|NCT01790633|O1|Outcome|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).~ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
139274|NCT01790633|E2|Reported Event|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test~Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
139275|NCT01790633|E1|Reported Event|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).~ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
139276|NCT01790594|B3|Baseline|Total|Total of all reporting groups
139277|NCT01790594|B2|Baseline|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139278|NCT01790594|B1|Baseline|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139279|NCT01790594|P3|Participant Flow|Enrolled, Not Randomized|Subjects who signed informed consent and were thus enrolled, but were not randomized to study treatment.
139280|NCT01790594|P2|Participant Flow|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139281|NCT01790594|P1|Participant Flow|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139282|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139283|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139284|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139285|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139286|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139287|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139288|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139289|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139290|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139291|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139292|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139382|NCT01790490|O1|Outcome|Ketamine Infusion 0.41 mg/kg Over 52 Minutes (K1)|Ketamine 0.41 (K1) followed by lorazepam (LZP) and then ketamine 0.71. Infusions are separated by 48 hours. This ordering allows for comparison between K1 and LZP, and between the post-K1 additive effects of LZP and K2.
139293|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139294|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139295|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139296|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139297|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139298|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139299|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139300|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139301|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139302|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139303|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139304|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139305|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139306|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139307|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139308|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139309|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139310|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139383|NCT01790490|O3|Outcome|Lorazepam Infusion 2 mg/kg Over 52 Minutes (LZP)|"Lorazepam 2 mg infused over 52 minutes (LZP)~Lorazepam 2 mg: 52 minute infusion of lorazepam 2 mg. This serves as an active control."
162185|NCT01704404|E3|Reported Event|Dose 3 TD-4208|"88 µg~TD-4208"
139311|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139312|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139313|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139314|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139315|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139316|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139317|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139318|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139319|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139320|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139321|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139322|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139323|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139324|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139325|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139326|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139327|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139328|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139384|NCT01790490|O2|Outcome|Ketamine Infusion 0.71 mg/kg Over 52 Minutes (K2)|"Ketamine 0.71 mg/kg infused over 52 min (K2)~Ketamine 0.71 mg/kg: 52 minute iv infusion of ketamine 0.71 mg/kg. This dose follows K1 in all 3 orderings."
139329|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139330|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139331|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139332|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139333|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139334|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139335|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139336|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139337|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139338|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139339|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139340|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139341|NCT01790594|O2|Outcome|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139342|NCT01790594|O1|Outcome|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139343|NCT01790594|E3|Reported Event|Enrolled, Not Randomized|Subjects who signed informed consent and were thus enrolled, but were not randomized to study treatment.
139344|NCT01790594|E2|Reported Event|Control|Induction: 500 mg of MEDROL was administered on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139345|NCT01790594|E1|Reported Event|Investigational|Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
139346|NCT01790581|B3|Baseline|Total|Total of all reporting groups
139347|NCT01790581|B2|Baseline|Balance Training w/ STARS|"Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. Exercises and reps that will be performed per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).~STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization."
139385|NCT01790490|O1|Outcome|Ketamine Infusion 0.41 mg/kg Over 52 Minutes (K1)|"Ketamine 0.41 mg/kg infused over 52 min (K1)~Ketamine 0.41 mg/kg: 52 minute iv infusion of ketamine 0.41 mg/kg"
139386|NCT01790490|E3|Reported Event|Ketamine 0.71 (K2)|Ketamine 0.71 mg/kg over 52 minutes (K2)
162186|NCT01704404|E2|Reported Event|Dose 2 TD-4208|"44 µg~TD-4208"
139348|NCT01790581|B1|Baseline|Balance Training|Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
139349|NCT01790581|P2|Participant Flow|Balance Training w/ STARS|"Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised sessions. Exercises and repetitions per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).~STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all treatment sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization."
139350|NCT01790581|P1|Participant Flow|Balance Training|Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
139351|NCT01790581|O2|Outcome|Balance Training w/ STARS|"Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. Exercises and reps that will be performed per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).~STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization."
139352|NCT01790581|O1|Outcome|Balance Training|Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
139353|NCT01790581|O2|Outcome|Balance Training w/ STARS|"Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. Exercises and reps that will be performed per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).~STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization."
139354|NCT01790581|O1|Outcome|Balance Training|Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
139355|NCT01790581|E2|Reported Event|Balance Training w/ STARS|"Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. Exercises and reps that will be performed per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).~STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization."
139387|NCT01790490|E2|Reported Event|Lorazepam 2 mg (LZP)|Lorazepam 2 mg (LZP) over 52 minutes
139388|NCT01790490|E1|Reported Event|Ketamine 0.41 (K1)|Ketamine 0.41 (K1) over 52 minutes
139389|NCT01790438|B3|Baseline|Total|Total of all reporting groups
139698|NCT01788163|O8|Outcome|Indonesia|Subjects in Indonesia that meet I/E and population criteria
139356|NCT01790581|E1|Reported Event|Balance Training|Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
139357|NCT01790568|B1|Baseline|Vorinostat|"Vorinostat, in combination with standard of care medications tacrolimus and methotrexate, for GVHD prophylaxis after unrelated donor stem cell transplant.~Vorinostat: administered at a dose of 100 mg orally, twice daily starting on day -10 in order to achieve steady-state prior to beginning the conditioning chemotherapy, and continued after transplant (day 0) until day +100."
139358|NCT01790568|P2|Participant Flow|Vorinostat Expansion|"Expansion of the NCI sponsored pilot trial of Vorinostat, in combination with standard of care medications tacrolimus and methotrexate, for GVHD prophylaxis after unrelated donor stem cell transplant.~Vorinostat: administered at a dose of 100 mg orally, twice daily starting on day -10 in order to achieve steady-state prior to beginning the conditioning chemotherapy, and continued after transplant (day 0) until day +100."
139359|NCT01790568|P1|Participant Flow|Vorinostat|"NCI sponsored pilot trial of Vorinostat, in combination with standard of care medications tacrolimus and methotrexate, for GVHD prophylaxis after unrelated donor stem cell transplant.~Vorinostat: administered at a dose of 100 mg orally, twice daily starting on day -10 in order to achieve steady-state prior to beginning the conditioning chemotherapy, and continued after transplant (day 0) until day +100."
139360|NCT01790568|O1|Outcome|Vorinostat|"Vorinostat, in combination with standard of care medications tacrolimus and methotrexate, for GVHD prophylaxis after unrelated donor stem cell transplant.~Vorinostat: administered at a dose of 100 mg orally, twice daily starting on day -10 in order to achieve steady-state prior to beginning the conditioning chemotherapy, and continued after transplant (day 0) until day +100."
139361|NCT01790568|O1|Outcome|Vorinostat|"Vorinostat, in combination with standard of care medications tacrolimus and methotrexate, for GVHD prophylaxis after unrelated donor stem cell transplant.~Vorinostat: administered at a dose of 100 mg orally, twice daily starting on day -10 in order to achieve steady-state prior to beginning the conditioning chemotherapy, and continued after transplant (day 0) until day +100."
139362|NCT01790568|O1|Outcome|Vorinostat|"Vorinostat, in combination with standard of care medications tacrolimus and methotrexate, for GVHD prophylaxis after unrelated donor stem cell transplant.~Vorinostat: administered at a dose of 100 mg orally, twice daily starting on day -10 in order to achieve steady-state prior to beginning the conditioning chemotherapy, and continued after transplant (day 0) until day +100."
139363|NCT01790568|E1|Reported Event|Vorinostat|"Vorinostat, in combination with standard of care medications tacrolimus and methotrexate, for GVHD prophylaxis after unrelated donor stem cell transplant.~Vorinostat: administered at a dose of 100 mg orally, twice daily starting on day -10 in order to achieve steady-state prior to beginning the conditioning chemotherapy, and continued after transplant (day 0) until day +100."
139364|NCT01790516|B3|Baseline|Total|Total of all reporting groups
139365|NCT01790516|B2|Baseline|Cetuximab|"Intensity modulated radiation therapy with concurrent cetuximab~cetuximab plus radiation therapy: Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation."
139366|NCT01790516|B1|Baseline|Cisplatin|"Intensity modulated radiation with concurrent cisplatin~platinum plus radiation: Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy"
139367|NCT01790516|P2|Participant Flow|Cetuximab|"Intensity modulated radiation therapy with concurrent cetuximab~cetuximab plus radiation therapy: Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation."
139368|NCT01790516|P1|Participant Flow|Cisplatin|"Intensity modulated radiation with concurrent cisplatin~platinum plus radiation: Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy"
139369|NCT01790516|O2|Outcome|Cetuximab|"Intensity modulated radiation therapy with concurrent cetuximab~cetuximab plus radiation therapy: Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation."
139370|NCT01790516|O1|Outcome|Cisplatin|"Intensity modulated radiation with concurrent cisplatin~platinum plus radiation: Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy"
139371|NCT01790516|E2|Reported Event|Cetuximab|"Intensity modulated radiation therapy with concurrent cetuximab~cetuximab plus radiation therapy: Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation."
139372|NCT01790516|E1|Reported Event|Cisplatin|"Intensity modulated radiation with concurrent cisplatin~platinum plus radiation: Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy"
139373|NCT01790490|B4|Baseline|Total|Total of all reporting groups
139374|NCT01790490|B3|Baseline|K1, K2, and LZP|K1 followed by K2 and then LZP. Infusions are separated by 48 hours. This allows for within-subject comparison of the post-K1 additive effects of K2 and LZP.
139375|NCT01790490|B2|Baseline|LZP, K1, and K2|LZP followed by K1 and then K2. Infusions are separated by 48 hours. This order allows for comparison between LZP and K1.
139376|NCT01790490|B1|Baseline|K1, LZP, and K2|Ketamine 0.41 (K1) followed by lorazepam (LZP) and then ketamine 0.71. Infusions are separated by 48 hours. This ordering allows for comparison between K1 and LZP, and between the post-K1 additive effects of LZP and K2.
139377|NCT01790490|P3|Participant Flow|K1, K2, and LZP|K1 followed by K2 and then LZP. Infusions are separated by 48 hours. This allows for within-subject comparison of the post-K1 additive effects of K2 and LZP.
139378|NCT01790490|P2|Participant Flow|LZP, K1, and K2|LZP followed by K1 and then K2. Infusions are separated by 48 hours. This order allows for comparison between LZP and K1.
139379|NCT01790490|P1|Participant Flow|K1, LZP, and K2|Ketamine 0.41 (K1) followed by lorazepam (LZP) and then ketamine 0.71. Infusions are separated by 48 hours. This ordering allows for comparison between K1 and LZP, and between the post-K1 additive effects of LZP and K2.
139699|NCT01788163|O7|Outcome|Malaysia|Subjects in Malaysia that meet I/E and population criteria
139390|NCT01790438|B2|Baseline|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
139391|NCT01790438|B1|Baseline|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
139392|NCT01790438|P2|Participant Flow|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin isophane suspension (NPH) was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
139393|NCT01790438|P1|Participant Flow|LY2605541|Administered by subcutaneous (SC) injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on Fasting Blood Glucose (FBG). LY2605541 was given alone or in combination with up to 3 pre-study oral antihyperglycemic medications [OAM(s)] whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
139394|NCT01790438|O2|Outcome|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
139395|NCT01790438|O1|Outcome|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
139396|NCT01790438|O2|Outcome|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
139397|NCT01790438|O1|Outcome|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
139398|NCT01790438|O2|Outcome|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
139399|NCT01790438|O1|Outcome|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
139400|NCT01790438|O2|Outcome|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose is 10 units and is adjusted weekly based on FBG. Human insulin NPH will be used alone or in combination with up to 3 pre-study OAM(s) whose use is not excluded in combination with insulin. Treatment may last up to 26 weeks. Some participants who are unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may be asked to add a second injection prior to the morning meal.
139401|NCT01790438|O1|Outcome|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose is 10 units and is adjusted weekly based on FBG. LY2605541 will be given alone or in combination with up to 3 pre-study OAM(s) whose use is not excluded in combination with insulin. Treatment may last up to 26 weeks.
139402|NCT01790438|O2|Outcome|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
139403|NCT01790438|O1|Outcome|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
139404|NCT01790438|O2|Outcome|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
139405|NCT01790438|O1|Outcome|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
139465|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
139406|NCT01790438|O2|Outcome|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
139407|NCT01790438|O1|Outcome|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
139408|NCT01790438|O2|Outcome|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
139409|NCT01790438|O1|Outcome|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
139410|NCT01790438|O2|Outcome|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
139411|NCT01790438|O1|Outcome|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
139412|NCT01790438|O2|Outcome|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
139413|NCT01790438|O1|Outcome|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
139414|NCT01790438|O2|Outcome|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
139415|NCT01790438|O1|Outcome|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
139416|NCT01790438|O2|Outcome|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
139417|NCT01790438|O1|Outcome|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
139418|NCT01790438|O2|Outcome|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
139419|NCT01790438|O1|Outcome|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
139420|NCT01790438|O2|Outcome|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
139421|NCT01790438|O1|Outcome|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
139484|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
139700|NCT01788163|O6|Outcome|Singapore|Subjects in Singapore that meet I/E and population criteria
139422|NCT01790438|O2|Outcome|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
139423|NCT01790438|O1|Outcome|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
139424|NCT01790438|O2|Outcome|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
139425|NCT01790438|O1|Outcome|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
139426|NCT01790438|O2|Outcome|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
139427|NCT01790438|O1|Outcome|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
139428|NCT01790438|O2|Outcome|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
139429|NCT01790438|O1|Outcome|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
139430|NCT01790438|O2|Outcome|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
139431|NCT01790438|O1|Outcome|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
139432|NCT01790438|O2|Outcome|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
139433|NCT01790438|O1|Outcome|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
139434|NCT01790438|O2|Outcome|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
139435|NCT01790438|O1|Outcome|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
139436|NCT01790438|O2|Outcome|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
139437|NCT01790438|O1|Outcome|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
139514|NCT01789606|B2|Baseline|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
139701|NCT01788163|O5|Outcome|Thailand|Subjects in Thailand that meet I/E and population criteria
139438|NCT01790438|O2|Outcome|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
139439|NCT01790438|O1|Outcome|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
139440|NCT01790438|E2|Reported Event|Human Insulin NPH|Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
139441|NCT01790438|E1|Reported Event|LY2605541|Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
139442|NCT01790178|B3|Baseline|Total|Total of all reporting groups
139443|NCT01790178|B2|Baseline|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
139444|NCT01790178|B1|Baseline|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
139445|NCT01790178|P2|Participant Flow|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
139446|NCT01790178|P1|Participant Flow|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
139447|NCT01790178|O2|Outcome|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
139448|NCT01790178|O1|Outcome|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
139449|NCT01790178|O2|Outcome|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
139450|NCT01790178|O1|Outcome|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
139451|NCT01790178|O2|Outcome|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
139452|NCT01790178|O1|Outcome|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
139453|NCT01790178|O2|Outcome|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
139454|NCT01790178|O1|Outcome|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
139455|NCT01790178|O2|Outcome|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
139456|NCT01790178|O1|Outcome|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
139457|NCT01790178|E2|Reported Event|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
139458|NCT01790178|E1|Reported Event|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
139459|NCT01789970|B3|Baseline|Total|Total of all reporting groups
139460|NCT01789970|B2|Baseline|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered extended-release hydrocodone tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
139461|NCT01789970|B1|Baseline|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
139462|NCT01789970|P3|Participant Flow|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
139463|NCT01789970|P2|Participant Flow|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
139464|NCT01789970|P1|Participant Flow|Hydrocodone ER (Open-Label Titration Period)|All participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours to identify a dosage deemed successful for managing their pain.
139466|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
139467|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
139468|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
139469|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
139470|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
139471|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
139472|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
139473|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
139474|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
139475|NCT01789970|O3|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
139476|NCT01789970|O2|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
139477|NCT01789970|O1|Outcome|Hydrocodone ER (Safety Analysis Set)|All enrolled participants who were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours. Includes days on hydrocodone ER during both the titration and treatment periods.
139478|NCT01789970|O4|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
139479|NCT01789970|O3|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
139480|NCT01789970|O2|Outcome|Opioid-Experienced (Open-Label Titration Period)|"Opioid-experienced participants were defined as those who were taking 10 mg or more per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening.~For opioid-experienced participants, the starting dose of hydrocodone ER tablets was to be approximately equivalent to 50% of the dose of opioid analgesic that they were receiving at screening and administered every 12 hours.~All participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours to identify a dosage deemed successful for managing their pain."
139481|NCT01789970|O1|Outcome|Opioid-Naive (Open-Label Titration Period)|"Opioid-naïve participants were defined as those who were taking tramadol or less than 10 mg per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening.~Opioid-naïve participants started at a 15-mg dose of hydrocodone ER tablets every 12 hours.~All participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours to identify a dosage deemed successful for managing their pain."
139482|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
139483|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
162187|NCT01704404|E1|Reported Event|Dose 1 TD-4208|"22 µg~TD-4208"
139485|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
139486|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
139487|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
139488|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
139489|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
139490|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
139491|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
139492|NCT01789970|E3|Reported Event|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
139493|NCT01789970|E2|Reported Event|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
139494|NCT01789970|E1|Reported Event|Hydrocodone ER (Open-Label Titration Period)|All participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours to identify a dosage deemed successful for managing their pain.
139495|NCT01789814|B3|Baseline|Total|Total of all reporting groups
139496|NCT01789814|B2|Baseline|Clopidogrel|"Clopidogrel oral loading dose of 600 mg administered preceding cardiac intervention~Clopidogrel: Clopidogrel 600 mg as a loading dose immediately prior to the start of procedure and 75 mg daily thereafter"
139497|NCT01789814|B1|Baseline|Prasugrel|"Prasugrel oral loading dose of 60 mg administered preceding cardiac intervention~Prasugrel: Patients will be randomized to prasugrel or clopidogrel to assess the effect of these drugs on inhibition of platelet aggregation following the cessation of bivalirudin therapy."
139498|NCT01789814|P2|Participant Flow|Clopidogrel|"Clopidogrel oral loading dose of 600 mg administered preceding cardiac intervention~Clopidogrel: Clopidogrel 600 mg as a loading dose immediately prior to the start of procedure and 75 mg daily thereafter"
139499|NCT01789814|P1|Participant Flow|Prasugrel|"Prasugrel oral loading dose of 60 mg administered preceding cardiac intervention~Prasugrel: Patients will be randomized to prasugrel or clopidogrel to assess the effect of these drugs on inhibition of platelet aggregation following the cessation of bivalirudin therapy."
139500|NCT01789814|O2|Outcome|Clopidogrel|"Clopidogrel oral loading dose of 600 mg administered preceding cardiac intervention~Clopidogrel: Clopidogrel 600 mg as a loading dose immediately prior to the start of procedure and 75 mg daily thereafter"
139501|NCT01789814|O1|Outcome|Prasugrel|"Prasugrel oral loading dose of 60 mg administered preceding cardiac intervention~Prasugrel: Patients will be randomized to prasugrel or clopidogrel to assess the effect of these drugs on inhibition of platelet aggregation following the cessation of bivalirudin therapy."
139502|NCT01789814|E2|Reported Event|Clopidogrel|"Clopidogrel oral loading dose of 600 mg administered preceding cardiac intervention~Clopidogrel: Clopidogrel 600 mg as a loading dose immediately prior to the start of procedure and 75 mg daily thereafter"
139503|NCT01789814|E1|Reported Event|Prasugrel|"Prasugrel oral loading dose of 60 mg administered preceding cardiac intervention~Prasugrel: Patients will be randomized to prasugrel or clopidogrel to assess the effect of these drugs on inhibition of platelet aggregation following the cessation of bivalirudin therapy."
139504|NCT01789775|B3|Baseline|Total|Total of all reporting groups
139505|NCT01789775|B2|Baseline|CD07805/47 Gel|"Intervention: Drug: CD07805/47 gel~CD07805/47 gel Placebo"
139506|NCT01789775|B1|Baseline|CD07805/47 Gel Placebo|"Placebo~Drug: CD07805/47 gel"
139507|NCT01789775|P2|Participant Flow|CD07805/47 Gel|"Intervention: Drug: CD07805/47 gel~CD07805/47 gel Placebo"
139508|NCT01789775|P1|Participant Flow|CD07805/47 Gel Placebo|"Placebo~Drug: CD07805/47 gel"
139509|NCT01789775|O2|Outcome|CD07805/47 Gel|"Intervention: Drug: CD07805/47 gel~CD07805/47 gel Placebo"
139510|NCT01789775|O1|Outcome|CD07805/47 Gel Placebo|"Placebo~Drug: CD07805/47 gel"
139511|NCT01789775|E2|Reported Event|CD07805/47 Gel|"Intervention: Drug: CD07805/47 gel~CD07805/47 gel Placebo"
139512|NCT01789775|E1|Reported Event|CD07805/47 Gel Placebo|"Placebo~Drug: CD07805/47 gel"
139513|NCT01789606|B3|Baseline|Total|Total of all reporting groups
139702|NCT01788163|O4|Outcome|Australia|Subjects in Australia that meet I/E and population criteria
139515|NCT01789606|B1|Baseline|Self-Selection Arm|Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
139516|NCT01789606|P2|Participant Flow|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
139517|NCT01789606|P1|Participant Flow|Self-Selection Arm|Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
139518|NCT01789606|O1|Outcome|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
139519|NCT01789606|O1|Outcome|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
139520|NCT01789606|O1|Outcome|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
139521|NCT01789606|O1|Outcome|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
139522|NCT01789606|O1|Outcome|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
139523|NCT01789606|O1|Outcome|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
139524|NCT01789606|O1|Outcome|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
139525|NCT01789606|O1|Outcome|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
139526|NCT01789606|O1|Outcome|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
139527|NCT01789606|O1|Outcome|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
139528|NCT01789606|O1|Outcome|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
139529|NCT01789606|O1|Outcome|Self-Selection Arm|Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
139530|NCT01789606|O1|Outcome|Self-Selection Arm|Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
139531|NCT01789606|O1|Outcome|Self-Selection Arm|Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
139532|NCT01789606|O1|Outcome|Self-Selection Arm|Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
139533|NCT01789606|E1|Reported Event|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
139534|NCT01789476|B3|Baseline|Total|Total of all reporting groups
139535|NCT01789476|B2|Baseline|Placebo|Matched placebo
139536|NCT01789476|B1|Baseline|CR845|CR845 (0.005 mg/kg) IV
139537|NCT01789476|P2|Participant Flow|Placebo|Matched placebo
139538|NCT01789476|P1|Participant Flow|CR845|CR845 (0.005 mg/kg) IV
139539|NCT01789476|O2|Outcome|CR845|CR845 (0.005 mg/kg) IV
139540|NCT01789476|O1|Outcome|Placebo|Matched placebo
139541|NCT01789476|O2|Outcome|CR845|CR845 (0.005 mg/kg) IV
139542|NCT01789476|O1|Outcome|Placebo|Matched placebo
139543|NCT01789476|O2|Outcome|CR845|CR845 (0.005 mg/kg) IV
139544|NCT01789476|O1|Outcome|Placebo|Matched placebo
139545|NCT01789476|E2|Reported Event|Placebo|Matched placebo
139546|NCT01789476|E1|Reported Event|CR845|CR845 (0.005 mg/kg) IV
139547|NCT01789255|B1|Baseline|Supportive Care (Vorinostat, Tacrolimus, Methotrexate)|Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
139548|NCT01789255|P1|Participant Flow|Supportive Care (Vorinostat, Tacrolimus, Methotrexate)|Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
139549|NCT01789255|O1|Outcome|Supportive Care (Vorinostat, Tacrolimus, Methotrexate)|Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
139550|NCT01789255|O1|Outcome|Supportive Care (Vorinostat, Tacrolimus, Methotrexate)|Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
139551|NCT01789255|E1|Reported Event|Supportive Care (Vorinostat, Tacrolimus, Methotrexate)|Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
139552|NCT01789138|B3|Baseline|Total|Total of all reporting groups
139553|NCT01789138|B2|Baseline|Adherence Counseling, Standard of Care|Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
139554|NCT01789138|B1|Baseline|Situated Optimal Adherence Intervention|"Situated Optimal Adherence Intervention: see 'Interventions' for more details.~Situated Optimal Adherence Intervention: Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts."
139555|NCT01789138|P2|Participant Flow|Adherence Counseling, Standard of Care|Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
139556|NCT01789138|P1|Participant Flow|Situated Optimal Adherence Intervention|"Situated Optimal Adherence Intervention: see 'Interventions' for more details.~Situated Optimal Adherence Intervention: Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts."
139557|NCT01789138|O2|Outcome|Adherence Counseling, Standard of Care|Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
139558|NCT01789138|O1|Outcome|Situated Optimal Adherence Intervention|"Situated Optimal Adherence Intervention: see 'Interventions' for more details.~Situated Optimal Adherence Intervention: Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts."
139559|NCT01789138|O2|Outcome|Adherence Counseling, Standard of Care|Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
139560|NCT01789138|O1|Outcome|Situated Optimal Adherence Intervention|"Situated Optimal Adherence Intervention: see 'Interventions' for more details.~Situated Optimal Adherence Intervention: Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts."
139561|NCT01789138|E2|Reported Event|Adherence Counseling, Standard of Care|Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
139583|NCT01788631|O2|Outcome|Placebo Arm|"Placebo infused over 48 hours~Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy."
139628|NCT01788228|O1|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
139562|NCT01789138|E1|Reported Event|Situated Optimal Adherence Intervention|"Situated Optimal Adherence Intervention: see 'Interventions' for more details.~Situated Optimal Adherence Intervention: Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts."
139563|NCT01788943|B3|Baseline|Total|Total of all reporting groups
139564|NCT01788943|B2|Baseline|Slow Nicotine Metabolizers|Nicotine Metabolite Radio of < 0.26.
139565|NCT01788943|B1|Baseline|Normal Nicotine Metabolizers|Nicotine Metabolite Radio of > or = 0.26
139566|NCT01788943|P2|Participant Flow|Normal Metabolizers|Participants with an NMR >= 0.26 will be considered normal metabolizers.
139567|NCT01788943|P1|Participant Flow|Slow Metabolizers.|Participants with an NMR < 0.26 will be considered slow metabolizers.
139568|NCT01788943|O2|Outcome|Normal Metabolizers|Subjects with an NMR of > or = 0.26.
139569|NCT01788943|O1|Outcome|Slow Metabolizers.|Subjects with an NMR < 0.26.
139570|NCT01788943|O2|Outcome|Normal Metabolizers|Subjects with an NMR of > or = 0.26.
139571|NCT01788943|O1|Outcome|Slow Metabolizers.|Subjects with an NMR < 0.26.
139572|NCT01788943|E2|Reported Event|Normal Metabolizers (NMR > or + 0.26)|No serious adverse events were observed.
139573|NCT01788943|E1|Reported Event|Slow Metabolizers (NMR < 0.26)|No serious adverse events were observed.
139574|NCT01788631|B3|Baseline|Total|Total of all reporting groups
139575|NCT01788631|B2|Baseline|Placebo Arm|"Placebo infused over 48 hours~Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy."
139576|NCT01788631|B1|Baseline|Regadenoson Arm|"1.44 mcg/kg/hour infused over 48 hours~Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes."
139577|NCT01788631|P2|Participant Flow|Placebo Arm|"Placebo infused over 48 hours~Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy."
139578|NCT01788631|P1|Participant Flow|Regadenoson Arm|"1.44 mcg/kg/hour infused over 48 hours~Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes."
139579|NCT01788631|O2|Outcome|Placebo Arm|"Placebo infused over 48 hours~Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy."
139580|NCT01788631|O1|Outcome|Regadenoson Arm|"1.44 mcg/kg/hour infused over 48 hours~Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes."
139581|NCT01788631|O2|Outcome|Placebo Arm|"Placebo infused over 48 hours~Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy."
139582|NCT01788631|O1|Outcome|Regadenoson Arm|"1.44 mcg/kg/hour infused over 48 hours~Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes."
162188|NCT01704287|B4|Baseline|Total|Total of all reporting groups
139584|NCT01788631|O1|Outcome|Regadenoson Arm|"1.44 mcg/kg/hour infused over 48 hours~Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes."
139585|NCT01788631|O2|Outcome|Placebo Arm|"Placebo infused over 48 hours~Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy."
139586|NCT01788631|O1|Outcome|Regadenoson Arm|"1.44 mcg/kg/hour infused over 48 hours~Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes."
139587|NCT01788631|O2|Outcome|Placebo Arm|"Placebo infused over 48 hours~Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy."
139588|NCT01788631|O1|Outcome|Regadenoson Arm|"1.44 mcg/kg/hour infused over 48 hours~Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes."
139589|NCT01788631|O2|Outcome|Placebo Arm|"Placebo infused over 48 hours~Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy."
139590|NCT01788631|O1|Outcome|Regadenoson Arm|"1.44 mcg/kg/hour infused over 48 hours~Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes."
139591|NCT01788631|O2|Outcome|Placebo Arm|"Placebo infused over 48 hours~Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy."
139592|NCT01788631|O1|Outcome|Regadenoson Arm|"1.44 mcg/kg/hour infused over 48 hours~Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes."
139593|NCT01788631|E2|Reported Event|Placebo Arm|"Placebo infused over 48 hours~Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy."
139594|NCT01788631|E1|Reported Event|Regadenoson Arm|"1.44 mcg/kg/hour infused over 48 hours~Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes."
139652|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
139595|NCT01788566|B1|Baseline|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
139596|NCT01788566|P1|Participant Flow|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
139597|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
139598|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
139599|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
139600|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
139601|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
139602|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
139603|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
139604|NCT01788566|E1|Reported Event|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
139605|NCT01788358|B1|Baseline|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
139606|NCT01788358|P1|Participant Flow|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
139607|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
139608|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
139609|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
139627|NCT01788228|O2|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
139703|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
139610|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
139611|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
139612|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
139613|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
139614|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
139615|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
139616|NCT01788358|E1|Reported Event|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
139617|NCT01788228|B3|Baseline|Total|Total of all reporting groups
139618|NCT01788228|B2|Baseline|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
139619|NCT01788228|B1|Baseline|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
139620|NCT01788228|P2|Participant Flow|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
139621|NCT01788228|P1|Participant Flow|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
139622|NCT01788228|O2|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
139623|NCT01788228|O1|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
139624|NCT01788228|O2|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
139625|NCT01788228|O1|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
139626|NCT01788228|O3|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine Group|Subjects received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
139629|NCT01788228|O3|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine Group|Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
139630|NCT01788228|O2|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
139631|NCT01788228|O1|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
139632|NCT01788228|O3|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine Group|Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
139633|NCT01788228|O2|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
139634|NCT01788228|O1|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
139635|NCT01788228|E2|Reported Event|Influenza A (H5N1)Virus Monovalent Vaccine ˃64 Years Group|Subjects ˃64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
139636|NCT01788228|E1|Reported Event|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
139637|NCT01788215|B3|Baseline|Total|Total of all reporting groups
139638|NCT01788215|B2|Baseline|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
139639|NCT01788215|B1|Baseline|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
139640|NCT01788215|P2|Participant Flow|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
139641|NCT01788215|P1|Participant Flow|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
139642|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
139643|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
139644|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
139645|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
139646|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
139647|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
139648|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
139649|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
139650|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
139651|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
139653|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
139654|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
139655|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
139656|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
139657|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
139658|NCT01788215|E2|Reported Event|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
139659|NCT01788215|E1|Reported Event|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
139660|NCT01788163|B10|Baseline|Total|Total of all reporting groups
139661|NCT01788163|B9|Baseline|Russia|Subjects in Russia that meet I/E and population criteria
139662|NCT01788163|B8|Baseline|Indonesia|Subjects in Indonesia that meet I/E and population criteria
139663|NCT01788163|B7|Baseline|Malaysia|Subjects in Malaysia that meet I/E and population criteria
139664|NCT01788163|B6|Baseline|Singapore|Subjects in Singapore that meet I/E and population criteria
139665|NCT01788163|B5|Baseline|Thailand|Subjects in Thailand that meet I/E and population criteria
139666|NCT01788163|B4|Baseline|Australia|Subjects in Australia that meet I/E and population criteria
139667|NCT01788163|B3|Baseline|South Korea|Subjects in South Korea that meet I/E and population criteria
139668|NCT01788163|B2|Baseline|Taiwan|Subjects in Taiwan that meet I/E and population criteria
139669|NCT01788163|B1|Baseline|China|Subjects in China that meet I/E and population criteria.
139670|NCT01788163|P9|Participant Flow|Russia|Subjects in Russia that meet I/E and population criteria
139671|NCT01788163|P8|Participant Flow|Indonesia|Subjects in Indonesia that meet I/E and population criteria
139672|NCT01788163|P7|Participant Flow|Malaysia|Subjects in Malaysia that meet I/E and population criteria
139673|NCT01788163|P6|Participant Flow|Singapore|Subjects in Singapore that meet I/E and population criteria
139674|NCT01788163|P5|Participant Flow|Thailand|Subjects in Thailand that meet I/E and population criteria
139675|NCT01788163|P4|Participant Flow|Australia|Subjects in Australia that meet I/E and population criteria
139676|NCT01788163|P3|Participant Flow|South Korea|Subjects in South Korea that meet I/E and population criteria
139677|NCT01788163|P2|Participant Flow|Taiwan|Subjects in Taiwan that meet I/E and population criteria
139678|NCT01788163|P1|Participant Flow|China|Subjects in China that meet Inclusion/Exclusion (I/E) and population criteria.
139679|NCT01788163|O18|Outcome|Russia-Mutation Status Negative|Subjects in Russia that meet I/E and population criteria, who had a Negative Mutation Status.
139680|NCT01788163|O17|Outcome|Russia-Mutation Status Positive|Subjects in Russia that meet I/E and population criteria, who had a Positive Mutation Status.
139681|NCT01788163|O16|Outcome|Indonesia-Mutation Status Negative|Subjects in Indonesia that meet I/E and population criteria, who had a Negative Mutation Status.
139682|NCT01788163|O15|Outcome|Indonesia-Mutation Status Positive|Subjects in Indonesia that meet I/E and population criteria, who had a Positive Mutation Status.
139683|NCT01788163|O14|Outcome|Malaysia-Mutation Status Negative|Subjects in Malaysia that meet I/E and population criteria, who had a Negative Mutation Status.
139684|NCT01788163|O13|Outcome|Malaysia-Mutation Status Positive|Subjects in Malaysia that meet I/E and population criteria, who had a Positive Mutation Status.
139685|NCT01788163|O12|Outcome|Singapore-Mutation Status Negative|Subjects in Singapore that meet I/E and population criteria, who had a Negative Mutation Status.
139686|NCT01788163|O11|Outcome|Singapore-Mutation Status Positive|Subjects in Singapore that meet I/E and population criteria, who had a Positive Mutation Status.
139687|NCT01788163|O10|Outcome|Thailand-Mutation Status Negative|Subjects in Thailand that meet I/E and population criteria, who had a Negative Mutation Status.
139688|NCT01788163|O9|Outcome|Thailand-Mutation Status Positive|Subjects in Thailand that meet I/E and population criteria, who had a Positive Mutation Status.
139689|NCT01788163|O8|Outcome|Australia-Mutation Status Negative|Subjects in Australia that meet I/E and population criteria, who had a Negative Mutation Status.
139690|NCT01788163|O7|Outcome|Australia-Mutation Status Positive|Subjects in Australia that meet I/E and population criteria, who had a Positive Mutation Status.
139691|NCT01788163|O6|Outcome|South Korea-Mutation Status Negative|Subjects in South Korea that meet I/E and population criteria, who had a Negative Mutation Status.
139692|NCT01788163|O5|Outcome|South Korea-Mutation Status Positive|Subjects in South Korea that meet I/E and population criteria, who had a Positive Mutation Status.
139693|NCT01788163|O4|Outcome|Taiwan-Mutation Status Negative|Subjects in Taiwan that meet I/E and population criteria, who had a Negative Mutation Status.
139694|NCT01788163|O3|Outcome|Taiwan-Mutation Status Positive|Subjects in Taiwan that meet I/E and population criteria, who had a Positive Mutation Status.
139709|NCT01788163|O1|Outcome|EGFR Mutation Positive|Participants who were EGFR Mutation Positive for the analysis population.
139710|NCT01788163|O2|Outcome|EGFR Mutation Negative|Participants who were EGFR Mutation Negative for the analysis population.
139711|NCT01788163|O1|Outcome|EGFR Mutation Positive|Participants who were EGFR Mutation Positive for the analysis population.
139712|NCT01788163|O2|Outcome|EGFR Mutation Negative|Participants who were EGFR Mutation Negative for the analysis population.
139713|NCT01788163|O1|Outcome|EGFR Mutation Positive|Participants who were EGFR Mutation Positive for the analysis population.
139714|NCT01788163|O2|Outcome|EGFR Mutation Negative|Participants who were EGFR Mutation Negative for the analysis population.
139715|NCT01788163|O1|Outcome|EGFR Mutation Positive|Participants who were EGFR Mutation Positive for the analysis population.
139716|NCT01788163|O2|Outcome|EGFR Mutation Negative|Participants who were EGFR Mutation Negative for the analysis population.
139717|NCT01788163|O1|Outcome|EGFR Mutation Positive|Participants who were EGFR Mutation Positive for the analysis population.
139718|NCT01788163|O4|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
139719|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
139720|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
139721|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria
139722|NCT01788163|O4|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
139723|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
139724|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
139725|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
139726|NCT01788163|O4|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
139727|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
139728|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
139729|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
139730|NCT01788163|O9|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
139731|NCT01788163|O8|Outcome|Indonesia|Subjects in Indonesia that meet I/E and population criteria
139732|NCT01788163|O7|Outcome|Malaysia|Subjects in Malaysia that meet I/E and population criteria
139733|NCT01788163|O6|Outcome|Singapore|Subjects in Singapore that meet I/E and population criteria
139734|NCT01788163|O5|Outcome|Thailand|Subjects in Thailand that meet I/E and population criteria
139735|NCT01788163|O4|Outcome|Australia|Subjects in Australia that meet I/E and population criteria
139736|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
139737|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
139738|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
139739|NCT01788163|O9|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
139740|NCT01788163|O8|Outcome|Indonesia|Subjects in Indonesia that meet I/E and population criteria
139741|NCT01788163|O7|Outcome|Malaysia|Subjects in Malaysia that meet I/E and population criteria
139742|NCT01788163|O6|Outcome|Singapore|Subjects in Singapore that meet I/E and population criteria
139743|NCT01788163|O5|Outcome|Thailand|Subjects in Thailand that meet I/E and population criteria
139744|NCT01788163|O4|Outcome|Australia|Subjects in Australia that meet I/E and population criteria
139745|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
139746|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
139747|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
139748|NCT01788163|O9|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
139749|NCT01788163|O8|Outcome|Indonesia|Subjects in Indonesia that meet I/E and population criteria
139750|NCT01788163|O7|Outcome|Malaysia|Subjects in Malaysia that meet I/E and population criteria
139751|NCT01788163|O6|Outcome|Singapore|Subjects in Singapore that meet I/E and population criteria
139752|NCT01788163|O5|Outcome|Thailand|Subjects in Thailand that meet I/E and population criteria
139753|NCT01788163|O4|Outcome|Australia|Subjects in Australia that meet I/E and population criteria
139754|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
139755|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
139756|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
139757|NCT01788163|O8|Outcome|Russia - Negative Predictive Value|Subjects in Russia that meet I/E and population criteria, who had a Negative Predictive test performed.
139758|NCT01788163|O7|Outcome|Russia - Positive Predictive Value|Subjects in Russia that meet I/E and population criteria, who had a Positive Predictive test performed.
139759|NCT01788163|O6|Outcome|South Korea - Negative Predictive Value|Subjects in South Korea that meet I/E and population criteria, who had a Negative Predictive test performed.
139760|NCT01788163|O5|Outcome|South Korea - Positive Predictive Value|Subjects in South Korea that meet I/E and population criteria, who had a Positive Predictive test performed.
139761|NCT01788163|O4|Outcome|Taiwan - Negative Predictive Value|Subjects in Taiwan that meet I/E and population criteria, who had a Negative Predictive test performed.
139762|NCT01788163|O3|Outcome|Taiwan - Positive Predictive Value|Subjects in Taiwan that meet I/E and population criteria, who had a Positive Predictive test performed.
139763|NCT01788163|O2|Outcome|China - Negative Predictive Value|Subjects in China that meet I/E and population criteria, who had a Negative Predictive test performed.
139764|NCT01788163|O1|Outcome|China - Positive Predictive Value|Subjects in China that meet I/E and population criteria, who had a Positive Predictive test performed.
139765|NCT01788163|O8|Outcome|Russia - Specificity|Subjects in Russia that meet I/E and population criteria, who had a specificity test performed.
139766|NCT01788163|O7|Outcome|Russia - Sensitivity|Subjects in Russia that meet I/E and population criteria, who had a sensitivity test performed.
139767|NCT01788163|O6|Outcome|South Korea - Specificity|Subjects in South Korea that meet I/E and population criteria, who had a specificity test performed.
139768|NCT01788163|O5|Outcome|South Korea - Sensitivity|Subjects in South Korea that meet I/E and population criteria, who had a sensitivity test performed.
139769|NCT01788163|O4|Outcome|Taiwan - Specificity|Subjects in Taiwan that meet I/E and population criteria, who had a specificity test performed.
139770|NCT01788163|O3|Outcome|Taiwan - Sensitivity|Subjects in Taiwan that meet I/E and population criteria, who had a sensitivity test performed.
139771|NCT01788163|O2|Outcome|China - Specificty|Subjects in China that meet I/E and population criteria, who had a specificity test performed.
139772|NCT01788163|O1|Outcome|China - Sensitivity|Subjects in China that meet I/E and population criteria, who had a sensitivity test performed.
139773|NCT01788163|O4|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
139774|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
139775|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
139776|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
139777|NCT01788163|O8|Outcome|Russia-Non-adenocarcinoma|Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
139778|NCT01788163|O7|Outcome|Russia-Adenocarcinoma|Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
139779|NCT01788163|O6|Outcome|South Korea-Non-adenocarcinoma|Subjects in South Korea that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
139780|NCT01788163|O5|Outcome|South Korea-Adenocarcinoma|Subjects in South Korea that meet I/E and population criteria with a histological type of Adenocarcinoma.
139781|NCT01788163|O4|Outcome|Taiwan-Non-adenocarcinoma|Subjects in Taiwan that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
139782|NCT01788163|O3|Outcome|Taiwan-Adenocarcinoma|Subjects in Taiwan that meet I/E and population criteria with a histological type of Adenocarcinoma.
139783|NCT01788163|O2|Outcome|China-Non-Adenocarcinoma|Subjects in China that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
139784|NCT01788163|O1|Outcome|China-Adenocarcinoma|Subjects in China that meet I/E and population criteria with a histological type of Adenocarcinoma.
139785|NCT01788163|O4|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
139786|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
139787|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
139788|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
139789|NCT01788163|O4|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
139790|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
139791|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
139792|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
139793|NCT01788163|O18|Outcome|Russia-Non-adenocarcinoma|Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
139794|NCT01788163|O17|Outcome|Russia-Adenocarcinoma|Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
139795|NCT01788163|O16|Outcome|Indonesia-Non-adenocarcinoma|Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
139796|NCT01788163|O15|Outcome|Indonesia-Adenocarcinoma|Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
139797|NCT01788163|O14|Outcome|Malaysia-Non-adenocarcinoma|Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
139798|NCT01788163|O13|Outcome|Malaysia-Adenocarcinoma|Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
139799|NCT01788163|O12|Outcome|Singapore-Non-adenocarcinoma|Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
139800|NCT01788163|O11|Outcome|Singapore-Adenocarcinoma|Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
139801|NCT01788163|O10|Outcome|Thailand-Non-adenocarcinoma|Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
139802|NCT01788163|O9|Outcome|Thailand-Adenocarcinoma|Subjects in Thailand that meet I/E and population criteria with a histological type of Adenocarcinoma.
139803|NCT01788163|O8|Outcome|Australia-Non-adenocarcinoma|Subjects in Australia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
139804|NCT01788163|O7|Outcome|Australia-Adenocarcinoma|Subjects in Australia that meet I/E and population criteria with a histological type of Adenocarcinoma.
139805|NCT01788163|O6|Outcome|South Korea-Non-adenocarcinoma|Subjects in South Korea that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
139806|NCT01788163|O5|Outcome|South Korea-Adenocarcinoma|Subjects in South Korea that meet I/E and population criteria with a histological type of Adenocarcinoma.
139807|NCT01788163|O4|Outcome|Taiwan-Non-adenocarcinoma|Subjects in Taiwan that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
139808|NCT01788163|O3|Outcome|Taiwan-Adenocarcinoma|Subjects in Taiwan that meet I/E and population criteria with a histological type of Adenocarcinoma.
139809|NCT01788163|O2|Outcome|China-Non-adenocarcinoma|Subjects in China that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
139810|NCT01788163|O1|Outcome|China-Adenocarcinoma|Subjects in China that meet I/E and population criteria with a histological type of Adenocarcinoma.
139811|NCT01788163|O9|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
139812|NCT01788163|O8|Outcome|Indonesia|Subjects in Indonesia that meet I/E and population criteria
139813|NCT01788163|O7|Outcome|Malaysia|Subjects in Malaysia that meet I/E and population criteria
139814|NCT01788163|O6|Outcome|Singapore|Subjects in Singapore that meet I/E and population criteria
139829|NCT01788163|E9|Reported Event|Russia|Subjects in Russia that meet I/E and population criteria
139830|NCT01788163|E8|Reported Event|Indonesia|Subjects in Indonesia that meet I/E and population criteria
139831|NCT01788163|E7|Reported Event|Malaysia|Subjects in Malaysia that meet I/E and population criteria
139832|NCT01788163|E6|Reported Event|Singapore|Subjects in Singapore that meet I/E and population criteria
139833|NCT01788163|E5|Reported Event|Thailand|Subjects in Thailand that meet I/E and population criteria
139834|NCT01788163|E4|Reported Event|Australia|Subjects in Australia that meet I/E and population criteria
139835|NCT01788163|E3|Reported Event|South Korea|Subjects in South Korea that meet I/E and population criteria
139836|NCT01788163|E2|Reported Event|Taiwan|Subjects in Taiwan that meet I/E and population criteria
139837|NCT01788163|E1|Reported Event|China|Subjects in China that meet I/E and population criteria.
139838|NCT01788046|B3|Baseline|Total|Total of all reporting groups
139839|NCT01788046|B2|Baseline|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
139840|NCT01788046|B1|Baseline|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
139841|NCT01788046|P2|Participant Flow|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
139842|NCT01788046|P1|Participant Flow|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
139843|NCT01788046|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
139844|NCT01788046|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
139845|NCT01788046|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
139846|NCT01788046|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
139847|NCT01788046|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
139848|NCT01788046|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
139849|NCT01788046|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
139850|NCT01788046|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
139851|NCT01788046|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
139852|NCT01788046|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
139853|NCT01788046|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
139854|NCT01788046|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
139855|NCT01788046|E2|Reported Event|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
139856|NCT01788046|E1|Reported Event|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
139857|NCT01787916|B1|Baseline|All Study Participants|Patients beginning with liraglutide will be switched to Placebo and vice versa
139858|NCT01787916|P2|Participant Flow|Placebo First, the Liraglutide|subjects were submitted to placebo and liraglutide in a randomly manner
139859|NCT01787916|P1|Participant Flow|Liraglutide First, Then Placebo|"Liraglutide, s.c., 1.8 mg, die, 24 weeks~First Intervention (24 weeks), Washout (4 weeks), and Second Intervention (24 weeks"
139860|NCT01787916|O2|Outcome|Placebo|"Placebo visually identical to study drug will be given~Liraglutide: Liraglutide will be compared to placebo for 24 weeks in a cross-over design"
139861|NCT01787916|O1|Outcome|Liraglutide|"Liraglutide, s.c., 1.8 mg, die, 24 weeks~Liraglutide: Liraglutide will be compared to placebo for 24 weeks in a cross-over design"
139862|NCT01787916|E2|Reported Event|Placebo|"Placebo visually identical to study drug will be given~Liraglutide: Liraglutide will be compared to placebo for 24 weeks in a cross-over design"
139863|NCT01787916|E1|Reported Event|Liraglutide|"Liraglutide, s.c., 1.8 mg, die, 24 weeks~Liraglutide: Liraglutide will be compared to placebo for 24 weeks in a cross-over design"
139864|NCT01787838|B1|Baseline|Health Education, Audit and Feedback|"Prospective single group intervention with retrospective control group with no intervention.~Focused Health Education: A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education.~The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about it."
139865|NCT01787838|P1|Participant Flow|Health Education, Audit and Feedback|"Prospective single group intervention with retrospective control group with no intervention.~Focused Health Education: A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education.~The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about it."
139866|NCT01787838|O1|Outcome|Health Education, Audit and Feedback|"Prospective single group intervention Focused Health Education: A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education.~The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about immunizations."
139867|NCT01787838|E1|Reported Event|Health Education, Audit and Feedback|"Prospective single group intervention with retrospective control group with no intervention.~Focused Health Education: A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education.~The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about it."
139868|NCT01787825|B1|Baseline|All Study Participants|"PillCam SB2 capsule and CapsoCam SV-1 capsule in random order, PillCam SB2 capsule: Capsule Endoscopy system, CapsoCam SV-1: Capsule endoscopy~The analysis population consisted of subjects that swallowed the capsules."
139869|NCT01787825|P2|Participant Flow|PillCam SB2 Then CapsoCam SV-1|Participants first received PillCam SB2 then 30-60 minutes later receive CapsoCam SV-1
139870|NCT01787825|P1|Participant Flow|CapsoCam SV-1 Then PillCam SB2|Participants first received CapsoCam SV-1 then 30-60 minutes later received Pillcam SB2
139871|NCT01787825|O2|Outcome|PillCam SB2|Subject preference for PillCam SB2
139872|NCT01787825|O1|Outcome|CapsoCam SV-1 Preference|Subject preference for CapsoCam SV-1
139873|NCT01787825|O2|Outcome|PillCam SB2|Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
139874|NCT01787825|O1|Outcome|CapsoCam SV-1|Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
139875|NCT01787825|O2|Outcome|PillCam SB2|Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
139876|NCT01787825|O1|Outcome|CapsoCam SV-1|Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
139877|NCT01787825|O2|Outcome|PillCam SB2|Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
139878|NCT01787825|O1|Outcome|CapsoCam SV-1|Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
139879|NCT01787825|E1|Reported Event|All Study Participants|PillCam SB Capsule and CapsoCam SV-1
139880|NCT01787799|B1|Baseline|SYNERGY Stent System|"SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)~SYNERGY: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating."
139881|NCT01787799|P1|Participant Flow|SYNERGY Stent System|"SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)~SYNERGY: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating."
139882|NCT01787799|O1|Outcome|SYNERGY Stent System|"SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)~SYNERGY: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating."
139883|NCT01787799|E1|Reported Event|SYNERGY Stent System|"SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)~SYNERGY: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating."
139884|NCT01787760|B4|Baseline|Total|Total of all reporting groups
139885|NCT01787760|B3|Baseline|Spectacle Lenses|Control spectacle lenses worn daily.
139886|NCT01787760|B2|Baseline|Test Soft Contact Lens C|Lenses will be worn in a daily disposable modality
139887|NCT01787760|B1|Baseline|Test Soft Contact Lens B|Lenses will be worn in a daily disposable modality
139888|NCT01787760|P3|Participant Flow|Spectacle Lenses|Control spectacle lenses worn daily.
139889|NCT01787760|P2|Participant Flow|Test Soft Contact Lens C|Lenses will be worn in a daily disposable modality
139890|NCT01787760|P1|Participant Flow|Test Soft Contact Lens B|Lenses will be worn in a daily disposable modality
139891|NCT01787760|O3|Outcome|Test Soft Contact Lens C|Lenses will be worn in a daily disposable modality.
139892|NCT01787760|O2|Outcome|Test Soft Contact Lens B|Lenses will be worn in a daily disposable modality.
139893|NCT01787760|O1|Outcome|Spectacle Lenses|Control spectacle lenses worn daily.
139894|NCT01787760|O3|Outcome|Test Soft Contact Lens C|Lenses will be worn in a daily disposable modality.
139895|NCT01787760|O2|Outcome|Test Soft Contact Lens B|Lenses will be worn in a daily disposable modality.
139896|NCT01787760|O1|Outcome|Spectacle Lenses|Control spectacle lenses worn daily.
139897|NCT01787760|E4|Reported Event|Not Randomized|Subjects who met the all study eligible criteria but did not randomize to the study arm.
139898|NCT01787760|E3|Reported Event|Test Soft Contact Lens C|Lenses will be worn in a daily disposable modality.
139899|NCT01787760|E2|Reported Event|Test Soft Contact Lens B|Lenses will be worn in a daily disposable modality.
139900|NCT01787760|E1|Reported Event|Spectacle Lenses|Control spectacle lenses worn daily.
139901|NCT01787591|B3|Baseline|Total|Total of all reporting groups
139902|NCT01787591|B2|Baseline|Metabolic Syndrome Participants|As a randomized crossover study design, participants were stratified by health status (healthy versus metabolic syndrome) and received fat-free milk, low-fat milk, full-fat milk, and soy milk in a randomized order.
140040|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
140041|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
139903|NCT01787591|B1|Baseline|Healthy Participants|As a randomized crossover study design, participants were stratified by health status (healthy versus metabolic syndrome) and received fat-free milk, low-fat milk, full-fat milk, and soy milk in a randomized order.
139904|NCT01787591|P4|Participant Flow|Acute Soy Milk Ingestion First|"Participants ingested soy milk first and then the remaining three milks in a randomized order: low-fat milk, full-fat milk, and fat-free milk.~Participants will ingest 1 cup of soy milk with 15 mg deuterium-labeled alpha-tocopherol.~Soy Milk: Soy milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
139905|NCT01787591|P3|Participant Flow|Acute Full-Fat Milk Ingestion First|"Participants ingested full-free milk first and then the remaining three milks in a randomized order: low-fat milk, low-fat milk, and soy milk.~Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
139906|NCT01787591|P2|Participant Flow|Acute Low-Fat Milk Ingestion First|"Participants ingested low-free milk first and then the remaining three milks in a randomized order: fat-fat milk, full-fat milk, and soy milk.~Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
139907|NCT01787591|P1|Participant Flow|Acute Fat-Free Milk Ingestion First|"Participants ingested fat-free milk first and then the remaining three milks in a randomized order: low-fat milk, full-fat milk, and soy milk.~Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.~Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
139908|NCT01787591|O4|Outcome|Acute Soy Milk Ingestion|Participants ingested 1 cup of soy milk with deuterium labeled alpha-tocopherol
139909|NCT01787591|O3|Outcome|Acute Full-Fat Milk Ingestion|"Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
139910|NCT01787591|O2|Outcome|Acute Low-Fat Milk Ingestion|"Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
139911|NCT01787591|O1|Outcome|Acute Fat-Free Milk Ingestion|"Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.~Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
139912|NCT01787591|O4|Outcome|Acute Soy Milk Ingestion|Participants ingested 1 cup of soy milk with deuterium labeled alpha-tocopherol
139913|NCT01787591|O3|Outcome|Acute Full-Fat Milk Ingestion|"Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
139914|NCT01787591|O2|Outcome|Acute Low-Fat Milk Ingestion|"Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
139915|NCT01787591|O1|Outcome|Acute Fat-Free Milk Ingestion|"Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.~Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
139916|NCT01787591|O4|Outcome|Acute Soy Milk Ingestion|Participants ingested 1 cup of soy milk with deuterium labeled alpha-tocopherol
139917|NCT01787591|O3|Outcome|Acute Full-Fat Milk Ingestion|"Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
139918|NCT01787591|O2|Outcome|Acute Low-Fat Milk Ingestion|"Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
139919|NCT01787591|O1|Outcome|Acute Fat-Free Milk Ingestion|"Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.~Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
139920|NCT01787591|O4|Outcome|Acute Soy Milk Ingestion|Participants ingested 1 cup of soy milk with deuterium labeled alpha-tocopherol
139921|NCT01787591|O3|Outcome|Acute Full-Fat Milk Ingestion|"Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
139922|NCT01787591|O2|Outcome|Acute Low-Fat Milk Ingestion|"Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
139923|NCT01787591|O1|Outcome|Acute Fat-Free Milk Ingestion|"Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.~Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
139924|NCT01787591|O4|Outcome|Acute Soy Milk Ingestion|Participants received 1 cup of soy milk with deuterium labeled alpha-tocopherol
139925|NCT01787591|O3|Outcome|Acute Full-Fat Milk Ingestion|"Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
139926|NCT01787591|O2|Outcome|Acute Low-Fat Milk Ingestion|"Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
139927|NCT01787591|O1|Outcome|Acute Fat-Free Milk Ingestion|"Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.~Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
139928|NCT01787591|E4|Reported Event|Acute Soy Milk Ingestion|"Participants will ingest 1 cup of soy milk with 15 mg deuterium-labeled alpha-tocopherol.~Soy Milk: Soy milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
139929|NCT01787591|E3|Reported Event|Acute Full-Fat Milk Ingestion|"Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
139930|NCT01787591|E2|Reported Event|Acute Low-Fat Milk Ingestion|"Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
139931|NCT01787591|E1|Reported Event|Acute Fat-Free Milk Ingestion|"Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.~Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
139932|NCT01787461|B3|Baseline|Total|Total of all reporting groups
139933|NCT01787461|B2|Baseline|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
139934|NCT01787461|B1|Baseline|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
139935|NCT01787461|P2|Participant Flow|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
139936|NCT01787461|P1|Participant Flow|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
139937|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
139938|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
139939|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
139940|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
139941|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
139942|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
139943|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
139944|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
139945|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
139946|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
139947|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
139948|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
139949|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
139950|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
139951|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
139952|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
139953|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
139954|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
139955|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
139956|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
139957|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
139958|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
139959|NCT01787461|E2|Reported Event|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
139960|NCT01787461|E1|Reported Event|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
139961|NCT01787383|B3|Baseline|Total|Total of all reporting groups
139962|NCT01787383|B2|Baseline|Ingenol Mebutate Gel Sequential Treatment|"Ingenol mebutate gel 0.05 %: Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities applied sequentially~Ingenol mebutate gel 0.015 %: Ingenol mebutate gel 0.015 % (Picato®) on face/scalp applied sequentially"
139963|NCT01787383|B1|Baseline|Ingenol Mebutate Gel Simultaneous Treatment|"Ingenol mebutate gel 0.05 %: Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities applied simultaneously~Ingenol mebutate gel 0.015 %: Ingenol mebutate gel 0.015 % (Picato®) on face/scalp applied simultaneously"
139964|NCT01787383|P2|Participant Flow|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
139965|NCT01787383|P1|Participant Flow|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
139966|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Convenience TSQM compliance was lower than the number of randomised subjects.
139967|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Convenience TSQM compliance was lower than the number of randomised subjects.
140042|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
140043|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
139968|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Global Satisfaction TSQM compliance was lower than the number of randomised subjects.
139969|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Global Satisfaction TSQM compliance was lower than the number of randomised subjects.
139970|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Side Effects TSQM compliance was lower than the number of randomised subjects.
139971|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Side EffectsTSQM compliance was lower than the number of randomised subjects.
139972|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Effectiveness TSQM compliance was lower than the number of randomised subjects.
139973|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Effectiveness TSQM compliance was lower than the number of randomised subjects.
139974|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
139975|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
139976|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
139977|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
139978|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
139979|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
139980|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
139981|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
139982|NCT01787383|E2|Reported Event|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015% and 0.05%) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
139983|NCT01787383|E1|Reported Event|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015% and 0.05%) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
139984|NCT01787279|B1|Baseline|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
139985|NCT01787279|P1|Participant Flow|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered peg interferon alpha-2a (PEGASYS), 40 kilodalton (kD), 180 micrograms (mcg), subcutaneously, once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
139986|NCT01787279|O1|Outcome|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
140044|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
140045|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
139987|NCT01787279|O1|Outcome|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
139988|NCT01787279|O1|Outcome|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
139989|NCT01787279|O1|Outcome|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
139990|NCT01787279|O1|Outcome|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
139991|NCT01787279|O1|Outcome|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
139992|NCT01787279|E1|Reported Event|Peginterferon Alpha-2a, 180 mcg/ 48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
139993|NCT01787240|B3|Baseline|Total|Total of all reporting groups
139994|NCT01787240|B2|Baseline|Escitalopram 10mg|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Escitalopram 10mg"
139995|NCT01787240|B1|Baseline|Placebo|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Placebo"
139996|NCT01787240|P2|Participant Flow|Escitalopram 10mg|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Escitalopram 10mg"
139997|NCT01787240|P1|Participant Flow|Placebo|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Placebo"
139998|NCT01787240|O2|Outcome|Escitalopram 10mg|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Escitalopram 10mg"
139999|NCT01787240|O1|Outcome|Placebo|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Placebo"
140000|NCT01787240|O2|Outcome|Escitalopram 10mg|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Escitalopram 10mg"
140001|NCT01787240|O1|Outcome|Placebo|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Placebo"
140002|NCT01787240|O2|Outcome|Phase 2 Active|Participants assigned to take active drug who did not respond by the end of phase 1 (Week 5 of study treatment) continued onto phase 2.
140003|NCT01787240|O1|Outcome|Phase 2 Placebo|Participants assigned to take placebo who did not respond by the end of phase 1 (Week 5 of study treatment) continued onto phase 2.
140004|NCT01787240|O1|Outcome|Eligible Patients|Number of patients who were screened and were determined to be eligible for the study.
140005|NCT01787240|E2|Reported Event|Escitalopram 10mg|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Escitalopram 10mg"
140006|NCT01787240|E1|Reported Event|Placebo|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Placebo"
140007|NCT01787188|B4|Baseline|Total|Total of all reporting groups
140008|NCT01787188|B3|Baseline|Placebo|Placebo: Capsule
140009|NCT01787188|B2|Baseline|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
140010|NCT01787188|B1|Baseline|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
140011|NCT01787188|P3|Participant Flow|Placebo|Placebo: Capsule
140012|NCT01787188|P2|Participant Flow|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
140013|NCT01787188|P1|Participant Flow|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
140014|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
140015|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
140016|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
140017|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
140018|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
140019|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
140020|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
140021|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
140022|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
140023|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
140024|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
140025|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
140026|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
140027|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
140028|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
140029|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
140030|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
140031|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
140032|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
140033|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
140034|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
140035|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
140036|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
140037|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
140038|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
140039|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
140046|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
140047|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
140048|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
140049|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
140050|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
140051|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
140052|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
140053|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
140054|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
140055|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
140056|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
140057|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
140058|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
140059|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
140060|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
140061|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
140062|NCT01787188|E3|Reported Event|Placebo|Placebo: Capsule
140063|NCT01787188|E2|Reported Event|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
140064|NCT01787188|E1|Reported Event|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
140065|NCT01787175|B3|Baseline|Total|Total of all reporting groups
140066|NCT01787175|B2|Baseline|Standard EHR|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
140067|NCT01787175|B1|Baseline|Integration Medication Manager|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
140068|NCT01787175|P2|Participant Flow|Standard EHR|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
140069|NCT01787175|P1|Participant Flow|Integrated Medication Manager|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
140070|NCT01787175|O2|Outcome|Standard EHR|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
140071|NCT01787175|O1|Outcome|Integrated Medication Manager|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
140072|NCT01787175|O2|Outcome|Standard EHR|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
140073|NCT01787175|O1|Outcome|Integrated Medication Manager|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
140074|NCT01787175|O2|Outcome|Standard EHR|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
140075|NCT01787175|O1|Outcome|Integrated Medication Manager|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
140076|NCT01787175|E2|Reported Event|Standard EHR|"Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.~Integrated Medication Manager: A theory based electronic health record. Half of the provider participants were assigned the IMM to use. The other half were assigned the VA's CPRS EHR to use for the simulation. Providers were randomly assigned to a EHR to use."
140077|NCT01787175|E1|Reported Event|Integrated Medication Manager|"Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.~Integrated Medication Manager: A theory based electronic health record. Half of the provider participants were assigned the IMM to use. The other half were assigned the VA's CPRS EHR to use for the simulation. Providers were randomly assigned to a EHR to use."
140078|NCT01787032|B7|Baseline|Total|Total of all reporting groups
140079|NCT01787032|B6|Baseline|BI 113608 + Voriconazole/ BI 113608 + Ketoconazole/ BI 113608|"The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
140080|NCT01787032|B5|Baseline|BI 113608 + Voriconazole/ BI 113608/ BI 113608 + Ketoconazole|"The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
140081|NCT01787032|B4|Baseline|BI 113608 + Ketoconazole/ BI 113608 + Voriconazole/ BI 113608|"The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
140082|NCT01787032|B3|Baseline|BI 113608 + Ketoconazole/ BI 113608/ BI 113608 + Voriconazole|"The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
140083|NCT01787032|B2|Baseline|BI 113608/BI 113608 + Voriconazole/ BI 113608 + Ketoconazole|"The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
140084|NCT01787032|B1|Baseline|BI 113608/BI 113608 + Ketoconazole/BI 113608 + Voriconazole|"The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
140085|NCT01787032|P6|Participant Flow|BI 113608 + Voriconazole/ BI 113608 + Ketoconazole/ BI 113608|"The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
140086|NCT01787032|P5|Participant Flow|BI 113608 + Voriconazole/ BI 113608/ BI 113608 + Ketoconazole|"The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
140087|NCT01787032|P4|Participant Flow|BI 113608 + Ketoconazole/ BI 113608 + Voriconazole/ BI 113608|"The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
140088|NCT01787032|P3|Participant Flow|BI 113608 + Ketoconazole/ BI 113608/ BI 113608 + Voriconazole|"The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
140112|NCT01786993|B2|Baseline|Biventricular Arm|Subjects were programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.
140155|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
140089|NCT01787032|P2|Participant Flow|BI 113608/BI 113608 + Voriconazole/ BI 113608 + Ketoconazole|"The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
140090|NCT01787032|P1|Participant Flow|BI 113608/BI 113608 + Ketoconazole/BI 113608 + Voriconazole|"The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
140091|NCT01787032|O3|Outcome|BI 113608 + Voriconazole|The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
140092|NCT01787032|O2|Outcome|BI 113608 + Ketoconazole|The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
140093|NCT01787032|O1|Outcome|BI 113608|The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.
140094|NCT01787032|O3|Outcome|BI 113608 + Voriconazole|The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
140095|NCT01787032|O2|Outcome|BI 113608 + Ketoconazole|The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
140096|NCT01787032|O1|Outcome|BI 113608|The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.
140097|NCT01787032|O3|Outcome|BI 113608 + Voriconazole|The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
140098|NCT01787032|O2|Outcome|BI 113608 + Ketoconazole|The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
140099|NCT01787032|O1|Outcome|BI 113608|The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.
140100|NCT01787032|O3|Outcome|BI 113608 + Voriconazole|The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
140101|NCT01787032|O2|Outcome|BI 113608 + Ketoconazole|The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
140102|NCT01787032|O1|Outcome|BI 113608|The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.
140103|NCT01787032|O3|Outcome|BI 113608 + Voriconazole|The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
140104|NCT01787032|O2|Outcome|BI 113608 + Ketoconazole|The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
140105|NCT01787032|O1|Outcome|BI 113608|The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.
140106|NCT01787032|E5|Reported Event|Voriconazole|The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) orally with 240 mL of water after an overnight fast of at least 10 hours.
140107|NCT01787032|E4|Reported Event|Ketoconazole|The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) orally with 240 mL of water after an overnight fast of at least 10 hours.
140108|NCT01787032|E3|Reported Event|BI 113608 + Voriconazole|The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
140109|NCT01787032|E2|Reported Event|BI 113608 + Ketoconazole|The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
140110|NCT01787032|E1|Reported Event|BI 113608|The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.
140111|NCT01786993|B3|Baseline|Total|Total of all reporting groups
140113|NCT01786993|B1|Baseline|MultiPoint Pacing Arm|Subjects were programmed to MPP between 3 and 9 months. MPP programming was stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.
140114|NCT01786993|P2|Participant Flow|Biventricular Arm|Subjects were programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.
140115|NCT01786993|P1|Participant Flow|Multi-point Pacing Arm|Subjects were programmed to MPP between 3 and 9 months. MPP programming was stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.
140116|NCT01786993|O2|Outcome|Biventricular Arm|"Traditional Biventricular Pacing~Traditional Biventricular Pacing: Subjects are programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available."
140117|NCT01786993|O1|Outcome|MultiPoint Pacing Arm|"MultiPoint Pacing~MultiPoint Pacing: Subjects are programmed to MPP between 3 and 9 months. MPP programming is stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study."
140118|NCT01786993|O1|Outcome|BiV/MPP Patients|Of 469 subjects who underwent an attempted implant, 31 subjects experienced a system-related complication between implant and 9 months (13 were LV lead-related, 16 were RA/RV lead-related and 3 were Quadripolar CRT-D pulse generator related. One subject experienced more than one category of complication).
140119|NCT01786993|E2|Reported Event|Biventricular Arm|Subjects were programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.
140120|NCT01786993|E1|Reported Event|MultiPoint Pacing Arm|Subjects were programmed to MPP between 3 and 9 months. MPP programming was stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.
140121|NCT01786954|B1|Baseline|Icare, Goldmann, Tonopen|"Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation.~Icare rebound tonometry~Tonopen applanation~Goldmann applanation"
140122|NCT01786954|P2|Participant Flow|Sequence 2: Icare Then Tonopen Then Goldmann|"Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry then Tonopen applanation then Goldmann applanation.~Icare rebound tonometry~Tonopen applanation~Goldmann applanation"
140123|NCT01786954|P1|Participant Flow|Sequence 1: Icare Then Goldmann Then Tonopen|"Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry then Goldmann applanation then Tonopen applanation.~Icare rebound tonometry~Goldmann applanation~Tonopen applanation"
140124|NCT01786954|O3|Outcome|Goldmann|
140125|NCT01786954|O2|Outcome|Tonopen|
140126|NCT01786954|O1|Outcome|Icare|
140127|NCT01786954|O3|Outcome|Goldmann|Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation.
140128|NCT01786954|O2|Outcome|Tonopen|Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation.
140129|NCT01786954|O1|Outcome|Icare|"Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation.~Icare rebound tonometry"
140130|NCT01786954|E2|Reported Event|Sequence 2: Icare, Tonopen, Goldmann|Sequence 2: Icare, then Tonopen, then Goldmann
140131|NCT01786954|E1|Reported Event|Sequence 1: Icare, Goldmann, Tonopen|Sequence 1: Icare, then Goldmann, then Tonopen
140132|NCT01786902|B3|Baseline|Total|Total of all reporting groups
140133|NCT01786902|B2|Baseline|Non-treatment Control Group|Height be measured with no treatment
140134|NCT01786902|B1|Baseline|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)~DA-3002"
140135|NCT01786902|P2|Participant Flow|Non-treatment Control Group|Height be measured with no treatment
140136|NCT01786902|P1|Participant Flow|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)~DA-3002"
140137|NCT01786902|O2|Outcome|Non-treatment Control Group|Height be measured with no treatment
140138|NCT01786902|O1|Outcome|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)~DA-3002"
140139|NCT01786902|O2|Outcome|Non-treatment Control Group|Height be measured with no treatment
140140|NCT01786902|O1|Outcome|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)~DA-3002"
140141|NCT01786902|O2|Outcome|Non-treatment Control Group|Height be measured with no treatment
140142|NCT01786902|O1|Outcome|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)~DA-3002"
140143|NCT01786902|E2|Reported Event|Non-treatment Control Group|Height be measured with no treatment
140144|NCT01786902|E1|Reported Event|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)~DA-3002"
140145|NCT01786876|B1|Baseline|Radiolabelled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
140146|NCT01786876|P1|Participant Flow|Radiolabelled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
140147|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
140148|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
140149|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
140150|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
140151|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
140152|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
140153|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
140154|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
140156|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
140157|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
140158|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
140159|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
140160|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
140161|NCT01786876|E1|Reported Event|Radiolabelled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
140162|NCT01786707|B3|Baseline|Total|Total of all reporting groups
140163|NCT01786707|B2|Baseline|Control Group|Patients in a control group will continue with standard medical treatment (SMT)
140164|NCT01786707|B1|Baseline|Autologous SC and HOT|"Autologous stem cells and hyperbaric oxygen therapy~Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT."
140165|NCT01786707|P2|Participant Flow|Control Group|Patients in a control group will continue with standard medical treatment (SMT)
140166|NCT01786707|P1|Participant Flow|Autologous Stem Cell and HOT|"Autologous stem cells (SC) and hyperbaric oxygen therapy~Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT."
140167|NCT01786707|O2|Outcome|Control Group|Patients in a control group will continue with standard medical treatment (SMT)
140168|NCT01786707|O1|Outcome|Autologous SC and HOT|"Autologous stem cells and hyperbaric oxygen therapy~Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT."
140169|NCT01786707|O2|Outcome|Control Group|Patients in a control group will continue with standard medical treatment (SMT)
140170|NCT01786707|O1|Outcome|Autologous SC and HOT|"Autologous stem cells and hyperbaric oxygen therapy~Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT."
140171|NCT01786707|E2|Reported Event|Control Group|Patients in a control group will continue with standard medical treatment (SMT)
140172|NCT01786707|E1|Reported Event|Autologous SC and HOT|"Autologous stem cells and hyperbaric oxygen therapy~Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT."
140173|NCT01786668|B5|Baseline|Total|Total of all reporting groups
140174|NCT01786668|B4|Baseline|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140175|NCT01786668|B3|Baseline|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140176|NCT01786668|B2|Baseline|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140177|NCT01786668|B1|Baseline|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140178|NCT01786668|P4|Participant Flow|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140179|NCT01786668|P3|Participant Flow|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140180|NCT01786668|P2|Participant Flow|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140181|NCT01786668|P1|Participant Flow|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the morning [AM] and afternoon [PM]) for a total of 12 weeks.
140182|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140183|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140184|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140185|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140186|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140187|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140188|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140189|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140190|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140191|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140192|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140193|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140194|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140195|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140196|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140197|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140198|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140199|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140200|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140201|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140202|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140203|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140204|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140205|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140206|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140207|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140208|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140209|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140210|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140211|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140212|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140213|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140214|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140215|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140216|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140217|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140218|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140219|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140363|NCT01786109|B3|Baseline|Placebo|One dose of placebo will be taken orally with water.
163899|NCT01698528|B3|Baseline|Total|Total of all reporting groups
140220|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140221|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140222|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140223|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140224|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140225|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140226|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140227|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140228|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140229|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140230|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140231|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140232|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140233|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140234|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140235|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140236|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140237|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140238|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140239|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140240|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140241|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140242|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140243|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140244|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140245|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140246|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140247|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140248|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140249|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140250|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140364|NCT01786109|B2|Baseline|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
140251|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140252|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140253|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140254|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140255|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140256|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140257|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140258|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140259|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140260|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140261|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140262|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140263|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140264|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140265|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140266|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140267|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140268|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140269|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140270|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140271|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140272|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140273|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140274|NCT01786668|E4|Reported Event|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140275|NCT01786668|E3|Reported Event|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
140276|NCT01786668|E2|Reported Event|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140277|NCT01786668|E1|Reported Event|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
140278|NCT01786629|B3|Baseline|Total|Total of all reporting groups
140279|NCT01786629|B2|Baseline|FDA Approved Bowel Preparation|"FDA approved bowel preparation containing electrolytes~FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy"
140280|NCT01786629|B1|Baseline|SUPREP Bowel Prep Kit|"SUPREP Bowel Prep Kit~SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy"
140281|NCT01786629|P2|Participant Flow|FDA Approved Bowel Preparation|"FDA approved bowel preparation containing electrolytes~FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy"
140282|NCT01786629|P1|Participant Flow|SUPREP Bowel Prep Kit|"SUPREP Bowel Prep Kit~SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy"
140365|NCT01786109|B1|Baseline|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
140283|NCT01786629|O2|Outcome|FDA Approved Bowel Preparation|"FDA approved bowel preparation containing electrolytes~FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy"
140284|NCT01786629|O1|Outcome|SUPREP Bowel Prep Kit|"SUPREP Bowel Prep Kit~SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy"
140285|NCT01786629|E2|Reported Event|FDA Approved Bowel Preparation|"FDA approved bowel preparation containing electrolytes~FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy"
140286|NCT01786629|E1|Reported Event|SUPREP Bowel Prep Kit|"SUPREP Bowel Prep Kit~SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy"
140287|NCT01786551|B1|Baseline|Eplerenone|Eplerenone 50 mg daily for 14 days
140288|NCT01786551|P1|Participant Flow|Eplerenone|Eplerenone 50 mg daily for 14 days
140289|NCT01786551|O1|Outcome|Eplerenone|Eplerenone 50 mg daily for 14 days
140290|NCT01786551|O1|Outcome|Eplerenone|Eplerenone 50 mg daily for 14 days
140291|NCT01786551|O1|Outcome|Eplerenone|Eplerenone 50 mg daily for 14 days
140292|NCT01786551|E1|Reported Event|Eplerenone|Eplerenone 50 mg daily for 14 days
140293|NCT01786330|B3|Baseline|Total|Total of all reporting groups
140294|NCT01786330|B2|Baseline|Control|"Group receives standard of care~Standard of Care"
140295|NCT01786330|B1|Baseline|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.~Procare abdominal binder"
140296|NCT01786330|P2|Participant Flow|Control|"Group receives standard of care~Standard of Care"
140297|NCT01786330|P1|Participant Flow|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.~Procare abdominal binder"
140298|NCT01786330|O2|Outcome|Control|"Group receives standard of care~Standard of Care"
140299|NCT01786330|O1|Outcome|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.~Procare abdominal binder"
140300|NCT01786330|O2|Outcome|Control|"Group receives standard of care~Standard of Care"
140301|NCT01786330|O1|Outcome|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.~Procare abdominal binder"
140302|NCT01786330|O2|Outcome|Control|"Group receives standard of care~Standard of Care"
140303|NCT01786330|O1|Outcome|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.~Procare abdominal binder"
140304|NCT01786330|O2|Outcome|Control|"Group receives standard of care~Standard of Care"
140305|NCT01786330|O1|Outcome|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.~Procare abdominal binder"
140306|NCT01786330|E2|Reported Event|Control|"Group receives standard of care~Standard of Care"
140307|NCT01786330|E1|Reported Event|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.~Procare abdominal binder"
140308|NCT01786252|B3|Baseline|Total|Total of all reporting groups
140309|NCT01786252|B2|Baseline|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.~Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
140310|NCT01786252|B1|Baseline|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.~human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
140311|NCT01786252|P2|Participant Flow|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.~Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
140312|NCT01786252|P1|Participant Flow|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.~human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
140313|NCT01786252|O2|Outcome|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.~Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
140328|NCT01786239|O2|Outcome|Placebo & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Placebo: The total daily dose for subjects assigned to placebo will be 2000 mg. This dose will start on day 1 and stay the same dose until study completion."
140314|NCT01786252|O1|Outcome|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.~human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
140315|NCT01786252|O2|Outcome|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.~Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
140316|NCT01786252|O1|Outcome|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.~human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
140317|NCT01786252|O2|Outcome|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.~Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
140318|NCT01786252|O1|Outcome|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.~human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
140319|NCT01786252|O2|Outcome|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.~Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
140320|NCT01786252|O1|Outcome|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.~human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
140321|NCT01786252|E2|Reported Event|Drug: Human Chorionic Gonadotropin (hCG)|Received hCG infusion on Day 3 Post-Ovulation Induction
140322|NCT01786252|E1|Reported Event|"IVF Media (Global-Trademark)"|Received IVF media infusion on Day 3 Post-Ovulation Induction
140323|NCT01786239|B3|Baseline|Total|Total of all reporting groups
140324|NCT01786239|B2|Baseline|Placebo & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Placebo: The total daily dose for subjects assigned to placebo will be 2000 mg. This dose will start on day 1 and stay the same dose until study completion."
140325|NCT01786239|B1|Baseline|Omega-3 Capsules & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Omega-3 capsules: The total daily dose for omega-3 subjects will be 740 mg of eicosapentanoic acid (EPA)and 400 mg of docosahexaenoic acid(DHA). This dose will start on day 1 and stay the same dose until study completion."
140326|NCT01786239|P2|Participant Flow|Amber50/50 Soybean Corn Placebo & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Amber 50/50 Soybean/Corn Placebo: The total daily dose for subjects assigned to placebo will be 2000 mg. This dose will start on day 1 and stay the same dose until study completion."
140327|NCT01786239|P1|Participant Flow|Omega-3 Capsules & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Omega-3 capsules: The total daily dose for omega-3 subjects will be 740 mg of eicosapentanoic acid (EPA)and 400 mg of docosahexaenoic acid(DHA). This dose will start on day 1 and stay the same dose until study completion."
140360|NCT01786161|E2|Reported Event|Intermittent Infusion|"infusion rate 1000mg/hr~Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr"
140361|NCT01786161|E1|Reported Event|Vancomycin Continous Infusion|"continuous 24 hours intravenous infusion~Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion"
140329|NCT01786239|O1|Outcome|Omega-3 Capsules & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Omega-3 capsules: The total daily dose for omega-3 subjects will be 740 mg of eicosapentanoic acid (EPA)and 400 mg of docosahexaenoic acid(DHA). This dose will start on day 1 and stay the same dose until study completion."
140330|NCT01786239|E2|Reported Event|Placebo & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Placebo: The total daily dose for subjects assigned to placebo will be 2000 mg. This dose will start on day 1 and stay the same dose until study completion."
140331|NCT01786239|E1|Reported Event|Omega-3 Capsules & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Omega-3 capsules: The total daily dose for omega-3 subjects will be 740 mg of eicosapentanoic acid (EPA)and 400 mg of docosahexaenoic acid(DHA). This dose will start on day 1 and stay the same dose until study completion."
140332|NCT01786174|B3|Baseline|Total|Total of all reporting groups
140333|NCT01786174|B2|Baseline|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
140334|NCT01786174|B1|Baseline|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
140335|NCT01786174|P2|Participant Flow|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
140336|NCT01786174|P1|Participant Flow|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
140337|NCT01786174|O2|Outcome|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
140338|NCT01786174|O1|Outcome|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
140339|NCT01786174|O2|Outcome|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
140340|NCT01786174|O1|Outcome|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
140341|NCT01786174|O2|Outcome|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
140342|NCT01786174|O1|Outcome|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
140343|NCT01786174|O2|Outcome|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
140344|NCT01786174|O1|Outcome|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
140345|NCT01786174|O2|Outcome|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
140346|NCT01786174|O1|Outcome|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
140347|NCT01786174|E2|Reported Event|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
140348|NCT01786174|E1|Reported Event|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
140349|NCT01786161|B3|Baseline|Total|Total of all reporting groups
140350|NCT01786161|B2|Baseline|Intermittent Infusion|"infusion rate 1000mg/hr~Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr"
140351|NCT01786161|B1|Baseline|Vancomycin Continous Infusion|Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion infusion rate 1000mg/hr
140352|NCT01786161|P2|Participant Flow|Vancomycin With Intermittent Dose Interval|"infusion rate 1000mg/hr~Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr"
140353|NCT01786161|P1|Participant Flow|Vancomycin With Continuous Infusion|"continuous 24 hours intravenous infusion~Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion"
140354|NCT01786161|O2|Outcome|Intermittent Infusion|"infusion rate 1000mg/hr~Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr"
140355|NCT01786161|O1|Outcome|Vancomycin Continous Infusion|"continuous 24 hours intravenous infusion~Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion"
140356|NCT01786161|O2|Outcome|Intermittent Infusion|"infusion rate 1000mg/hr~Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr"
140357|NCT01786161|O1|Outcome|Vancomycin Continous Infusion|"continuous 24 hours intravenous infusion~Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion"
140358|NCT01786161|O2|Outcome|Vancomycin With Intermittent Dose Interval|"infusion rate 1000mg/hr~Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr"
140359|NCT01786161|O1|Outcome|Vancomycin With Continuous Infusion|"continuous 24 hours intravenous infusion~Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion"
140362|NCT01786109|B4|Baseline|Total|Total of all reporting groups
140366|NCT01786109|P3|Participant Flow|Placebo|One dose of placebo will be taken orally with water.
140367|NCT01786109|P2|Participant Flow|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
140368|NCT01786109|P1|Participant Flow|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
140369|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
140370|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
140371|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
140372|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
140373|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
140374|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
140375|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
140376|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
140377|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
140378|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
140379|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
140380|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
140381|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
140382|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
140383|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
140384|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
140385|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
140386|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
140387|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
140388|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
140389|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
140390|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
140391|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
140392|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
140393|NCT01786109|E3|Reported Event|Placebo|One dose of placebo will be taken orally with water.
140394|NCT01786109|E2|Reported Event|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
140395|NCT01786109|E1|Reported Event|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
140396|NCT01785875|B1|Baseline|Etelcalcetide|All participants received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks during the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140397|NCT01785875|P3|Participant Flow|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140398|NCT01785875|P2|Participant Flow|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140399|NCT01785875|P1|Participant Flow|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140400|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140401|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140402|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140403|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140404|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140405|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140406|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140407|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140408|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140409|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140410|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140411|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140412|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140413|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140414|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140415|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140416|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140417|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140418|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140419|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140420|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140421|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140422|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140423|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140424|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140498|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
140425|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140426|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140427|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140428|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140429|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140430|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140431|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140432|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140433|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140434|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140435|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140436|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140437|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140438|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140439|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140440|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140441|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140442|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140443|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
144025|NCT01772550|E3|Reported Event|20 GA BD Nexiva Diffusics - Nonrandomized|
140444|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140445|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140446|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140447|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140448|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140449|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140450|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140451|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140452|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140453|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140454|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140455|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140456|NCT01785875|O1|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140457|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140458|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140459|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140460|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140461|NCT01785875|E4|Reported Event|Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140462|NCT01785875|E3|Reported Event|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140499|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
140500|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
140463|NCT01785875|E2|Reported Event|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140464|NCT01785875|E1|Reported Event|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
140465|NCT01785849|B3|Baseline|Total|Total of all reporting groups
140466|NCT01785849|B2|Baseline|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
140467|NCT01785849|B1|Baseline|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
140468|NCT01785849|P2|Participant Flow|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
140469|NCT01785849|P1|Participant Flow|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
140470|NCT01785849|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
140471|NCT01785849|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
140472|NCT01785849|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
140473|NCT01785849|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
140474|NCT01785849|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
140475|NCT01785849|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
140476|NCT01785849|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
140477|NCT01785849|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
140478|NCT01785849|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
140479|NCT01785849|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
140480|NCT01785849|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
140481|NCT01785849|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
140482|NCT01785849|E2|Reported Event|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
140483|NCT01785849|E1|Reported Event|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
140484|NCT01785628|B3|Baseline|Total|Total of all reporting groups
140485|NCT01785628|B2|Baseline|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
140486|NCT01785628|B1|Baseline|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
140487|NCT01785628|P2|Participant Flow|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
140488|NCT01785628|P1|Participant Flow|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
140489|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
140490|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
140491|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
140492|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
140493|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
140494|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
140495|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
140496|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
140497|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
140501|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
140502|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
140503|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
140504|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
140505|NCT01785628|E2|Reported Event|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
140506|NCT01785628|E1|Reported Event|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
140507|NCT01785615|B4|Baseline|Total|Total of all reporting groups
140508|NCT01785615|B3|Baseline|Healthy Participants|
140509|NCT01785615|B2|Baseline|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
140510|NCT01785615|B1|Baseline|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
140511|NCT01785615|P4|Participant Flow|Metabolic Syndrome Women|These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
140512|NCT01785615|P3|Participant Flow|Healthy Women|Women without metabolic syndrome
140513|NCT01785615|P2|Participant Flow|Sugar Pill|"44 women with metabolic syndrome randomized to placebo for 6 weeks~Placebo : 80mg"
140514|NCT01785615|P1|Participant Flow|Atorvastatin|"44 women with metabolic syndrome randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
140515|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
140516|NCT01785615|O1|Outcome|Healthy Women|
140517|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
140518|NCT01785615|O1|Outcome|Healthy Women|
140519|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
140520|NCT01785615|O1|Outcome|Healthy Women|
140521|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
140522|NCT01785615|O1|Outcome|Healthy Women|
140523|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
140524|NCT01785615|O1|Outcome|Healthy Women|
140525|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
140526|NCT01785615|O1|Outcome|Healthy Women|
140527|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
140528|NCT01785615|O1|Outcome|Healthy Women|
140529|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
140530|NCT01785615|O1|Outcome|Healthy Women|
140531|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
140532|NCT01785615|O1|Outcome|Healthy Women|
140533|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
140534|NCT01785615|O1|Outcome|Healthy Women|
140535|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
140536|NCT01785615|O1|Outcome|Healthy Women|
140537|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
140538|NCT01785615|O1|Outcome|Healthy Women|
140539|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
140540|NCT01785615|O1|Outcome|Healthy Women|
140541|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
140542|NCT01785615|O1|Outcome|Healthy Women|
140543|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
140544|NCT01785615|O1|Outcome|Healthy Women|
140545|NCT01785615|O2|Outcome|Metabolic Syndrome Women|These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
140546|NCT01785615|O1|Outcome|Healthy Women|Women without metabolic syndrome
140547|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
140548|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
140549|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
140550|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
140551|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
140552|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
140553|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
140554|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
140555|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
140556|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
140557|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
163963|NCT01697956|B3|Baseline|Total|Total of all reporting groups
140558|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
140559|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
140560|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
140561|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
140562|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
140563|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
140564|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
140565|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
140566|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
140567|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
140568|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
140569|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo: 80mg"
140570|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin: 80mg"
140571|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
140572|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
140573|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
140574|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
140575|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
140576|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
140577|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
140578|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
140579|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
140580|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
140581|NCT01785615|E2|Reported Event|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
140582|NCT01785615|E1|Reported Event|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
140583|NCT01785602|B3|Baseline|Total|Total of all reporting groups
140584|NCT01785602|B2|Baseline|Placebo|Participants received matching placebo to QAW039.
140585|NCT01785602|B1|Baseline|QAW039|Participants received QAW039 450 mg daily by mouth.
140586|NCT01785602|P2|Participant Flow|Placebo|Participants received matching placebo to QAW039.
140587|NCT01785602|P1|Participant Flow|QAW039|Participants received QAW039 450 mg daily by mouth.
140588|NCT01785602|O2|Outcome|Placebo|Participants received matching placebo to QAW039.
140589|NCT01785602|O1|Outcome|QAW039|Participants received QAW039 450 mg daily by mouth.
140590|NCT01785602|O2|Outcome|Placebo|Participants received matching placebo to QAW039.
140591|NCT01785602|O1|Outcome|QAW039|Participants received QAW039 450 mg daily by mouth.
140592|NCT01785602|E2|Reported Event|Placebo|Participants received matching placebo to QAW039.
140593|NCT01785602|E1|Reported Event|QAW039|Participants received QAW039 450 mg daily by mouth.
140594|NCT01785524|B3|Baseline|Total|Total of all reporting groups
140595|NCT01785524|B2|Baseline|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
140596|NCT01785524|B1|Baseline|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
140597|NCT01785524|P2|Participant Flow|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
140646|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
164014|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
140598|NCT01785524|P1|Participant Flow|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
140599|NCT01785524|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
140600|NCT01785524|O1|Outcome|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
140601|NCT01785524|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
140602|NCT01785524|O1|Outcome|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
140603|NCT01785524|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
140604|NCT01785524|O1|Outcome|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
140605|NCT01785524|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
140647|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
140606|NCT01785524|O1|Outcome|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
140607|NCT01785524|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
140608|NCT01785524|O1|Outcome|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
140609|NCT01785524|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
140610|NCT01785524|O1|Outcome|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
140611|NCT01785524|E2|Reported Event|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
140612|NCT01785524|E1|Reported Event|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
140613|NCT01785472|B4|Baseline|Total|Total of all reporting groups
140614|NCT01785472|B3|Baseline|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
140615|NCT01785472|B2|Baseline|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
140616|NCT01785472|B1|Baseline|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
140617|NCT01785472|P3|Participant Flow|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
164015|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
140618|NCT01785472|P2|Participant Flow|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
140619|NCT01785472|P1|Participant Flow|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
140620|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
140621|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
140622|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
140623|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
140624|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
140625|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
140626|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
140627|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
140628|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
140629|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
140630|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
140631|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
140632|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
140633|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
140634|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
140635|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
140636|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
140637|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
140638|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
140639|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
140640|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
140641|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
140642|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
140643|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
140644|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
140645|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
140648|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
140649|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
140650|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
140651|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
140652|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
140653|NCT01785472|O2|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
140654|NCT01785472|O1|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
140655|NCT01785472|O2|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
140656|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
140657|NCT01785472|E3|Reported Event|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily
140658|NCT01785472|E2|Reported Event|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
140659|NCT01785472|E1|Reported Event|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily
140660|NCT01785186|B6|Baseline|Total|Total of all reporting groups
140661|NCT01785186|B5|Baseline|HRZE|"HRZE: Isoniazid, rifampicin standard, pyrazinamide, ethambutol~Rifampicin: Rifampicin 10 to 35 mg/kg~Moxifloxacin: Moxifloxacin 400mg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~ethambutol: ethambutol 275 mg~pyridoxine: pyridoxine 25 mg"
140662|NCT01785186|B4|Baseline|HR20ZM|"Arm 4 (R20M): HR20ZM isoniazid, rifampicin 20 mg/kg, pyrazinamide, moxifloxacin 400 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
140663|NCT01785186|B3|Baseline|HR20ZQ|"Arm 3 (R20Q): HR20ZQ isoniazid, rifampicin 20 mg/kg, pyrazinamide, SQ109 300 mg~SQ109: SQ109 300 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
140664|NCT01785186|B2|Baseline|Arm 1 (R35)|"Arm 1 (R35): HR35ZE isoniazid, rifampicin 35 mg/kg, pyrazinamide, ethambutol~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~ethambutol: ethambutol 275 mg~pyridoxine: pyridoxine 25 mg"
140665|NCT01785186|B1|Baseline|HRZQ|"Arm 2 (Q): HRZQ isoniazid, rifampicin standard, pyrazinamide, SQ109 300 mg~SQ109: SQ109 300 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
140666|NCT01785186|P5|Participant Flow|HRZE|"HRZE: Isoniazid, rifampicin standard, pyrazinamide, ethambutol~Rifampicin: Rifampicin 10 to 35 mg/kg~Moxifloxacin: Moxifloxacin 400mg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~ethambutol: ethambutol 275 mg~pyridoxine: pyridoxine 25 mg"
140667|NCT01785186|P4|Participant Flow|HR20ZM|"Arm 4 (R20M): HR20ZM isoniazid, rifampicin 20 mg/kg, pyrazinamide, moxifloxacin 400 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
140668|NCT01785186|P3|Participant Flow|HR20ZQ|"Arm 3 (R20Q): HR20ZQ isoniazid, rifampicin 20 mg/kg, pyrazinamide, SQ109 300 mg~SQ109: SQ109 300 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
140669|NCT01785186|P2|Participant Flow|Arm 1 (R35)|"Arm 1 (R35): HR35ZE isoniazid, rifampicin 35 mg/kg, pyrazinamide, ethambutol~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~ethambutol: ethambutol 275 mg~pyridoxine: pyridoxine 25 mg"
140670|NCT01785186|P1|Participant Flow|HRZQ|"Arm 2 (Q): HRZQ isoniazid, rifampicin standard, pyrazinamide, SQ109 300 mg~SQ109: SQ109 300 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
140671|NCT01785186|O5|Outcome|HRZE|"HRZE: Isoniazid, rifampicin standard, pyrazinamide, ethambutol~Rifampicin: Rifampicin 10 to 35 mg/kg~Moxifloxacin: Moxifloxacin 400mg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~ethambutol: ethambutol 275 mg~pyridoxine: pyridoxine 25 mg"
140672|NCT01785186|O4|Outcome|HR20ZM|"Arm 4 (R20M): HR20ZM isoniazid, rifampicin 20 mg/kg, pyrazinamide, moxifloxacin 400 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
140673|NCT01785186|O3|Outcome|HR20ZQ|"Arm 3 (R20Q): HR20ZQ isoniazid, rifampicin 20 mg/kg, pyrazinamide, SQ109 300 mg~SQ109: SQ109 300 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
140674|NCT01785186|O2|Outcome|Arm 1 (R35)|"Arm 1 (R35): HR35ZE isoniazid, rifampicin 35 mg/kg, pyrazinamide, ethambutol~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~ethambutol: ethambutol 275 mg~pyridoxine: pyridoxine 25 mg"
140675|NCT01785186|O1|Outcome|HRZQ|"Arm 2 (Q): HRZQ isoniazid, rifampicin standard, pyrazinamide, SQ109 300 mg~SQ109: SQ109 300 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
140676|NCT01785186|O5|Outcome|HRZE|"HRZE: Isoniazid, rifampicin standard, pyrazinamide, ethambutol~Rifampicin: Rifampicin 10 to 35 mg/kg~Moxifloxacin: Moxifloxacin 400mg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~ethambutol: ethambutol 275 mg~pyridoxine: pyridoxine 25 mg"
140677|NCT01785186|O4|Outcome|HR20ZM|"Arm 4 (R20M): HR20ZM isoniazid, rifampicin 20 mg/kg, pyrazinamide, moxifloxacin 400 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
140678|NCT01785186|O3|Outcome|HR20ZQ|"Arm 3 (R20Q): HR20ZQ isoniazid, rifampicin 20 mg/kg, pyrazinamide, SQ109 300 mg~SQ109: SQ109 300 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
140679|NCT01785186|O2|Outcome|HRZQ|"Arm 2 (Q): HRZQ isoniazid, rifampicin standard, pyrazinamide, SQ109 300 mg~SQ109: SQ109 300 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
140680|NCT01785186|O1|Outcome|Arm 1 (R35)|"Arm 1 (R35): HR35ZE isoniazid, rifampicin 35 mg/kg, pyrazinamide, ethambutol~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~ethambutol: ethambutol 275 mg~pyridoxine: pyridoxine 25 mg"
140681|NCT01785186|O5|Outcome|HRZE|"HRZE: Isoniazid, rifampicin standard, pyrazinamide, ethambutol~Rifampicin: Rifampicin 10 to 35 mg/kg~Moxifloxacin: Moxifloxacin 400mg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~ethambutol: ethambutol 275 mg~pyridoxine: pyridoxine 25 mg"
140682|NCT01785186|O4|Outcome|HR20ZM|"Arm 4 (R20M): HR20ZM isoniazid, rifampicin 20 mg/kg, pyrazinamide, moxifloxacin 400 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
140683|NCT01785186|O3|Outcome|HR20ZQ|"Arm 3 (R20Q): HR20ZQ isoniazid, rifampicin 20 mg/kg, pyrazinamide, SQ109 300 mg~SQ109: SQ109 300 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
140684|NCT01785186|O2|Outcome|HRZQ|"Arm 2 (Q): HRZQ isoniazid, rifampicin standard, pyrazinamide, SQ109 300 mg~SQ109: SQ109 300 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
140685|NCT01785186|O1|Outcome|Arm 1 (R35)|"Arm 1 (R35): HR35ZE isoniazid, rifampicin 35 mg/kg, pyrazinamide, ethambutol~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~ethambutol: ethambutol 275 mg~pyridoxine: pyridoxine 25 mg"
140686|NCT01785186|E5|Reported Event|HRZE|"HRZE: Isoniazid, rifampicin standard, pyrazinamide, ethambutol~Rifampicin: Rifampicin 10 to 35 mg/kg~Moxifloxacin: Moxifloxacin 400mg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~ethambutol: ethambutol 275 mg~pyridoxine: pyridoxine 25 mg"
140687|NCT01785186|E4|Reported Event|HR20ZM|"Arm 4 (R20M): HR20ZM isoniazid, rifampicin 20 mg/kg, pyrazinamide, moxifloxacin 400 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
140688|NCT01785186|E3|Reported Event|HR20ZQ|"Arm 3 (R20Q): HR20ZQ isoniazid, rifampicin 20 mg/kg, pyrazinamide, SQ109 300 mg~SQ109: SQ109 300 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
140689|NCT01785186|E2|Reported Event|Arm 1 (R35)|"Arm 1 (R35): HR35ZE isoniazid, rifampicin 35 mg/kg, pyrazinamide, ethambutol~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~ethambutol: ethambutol 275 mg~pyridoxine: pyridoxine 25 mg"
140690|NCT01785186|E1|Reported Event|HRZQ|"Arm 2 (Q): HRZQ isoniazid, rifampicin standard, pyrazinamide, SQ109 300 mg~SQ109: SQ109 300 mg~Rifampicin: Rifampicin 10 to 35 mg/kg~isoniazid: isoniazid 75 mg~pyrazinamide: pyrazinamide 400 mg~pyridoxine: pyridoxine 25 mg"
140691|NCT01785160|B1|Baseline|Overall Study|Total number of patients randomised and treated in the study.This was a open label trial with two periods in a fixed sequence. All subjects were to receive the following 2 treatments, A]Raltegravir B]Raltegravir+Faldaprevir The two treatments were separated by washout period of at least 7 days.
140692|NCT01785160|P1|Participant Flow|Overall Study|Total number of patients randomised and treated in the study.This was a open label trial with two periods in a fixed sequence. All subjects were to receive the following 2 treatments, A]Raltegravir B]Raltegravir+Faldaprevir. The two treatments were separated by washout period of at least 7 days.
140693|NCT01785160|O2|Outcome|Raltegravir + Faldaprevir|"Raltegravir coated tablets and Faldaprevir soft gelatin capsules~Oral with 240 mL of water Day 1: 400 mg raltegravir twice daily and 240 mg faldaprevir twice daily (loading dose) Days 2 to 5: 400 mg raltegravir twice daily and 240 mg faldaprevir once daily Day 6: 400 mg raltegravir once daily and 240 mg faldaprevir once daily"
140694|NCT01785160|O1|Outcome|Raltegravir|"Raltegravir coated tablets~Oral with 240 mL of water Days 1 to 3: 400 mg raltegravir twice daily Day 4: 400 mg raltegravir once daily"
140695|NCT01785160|O2|Outcome|Raltegravir + Faldaprevir|"Raltegravir coated tablets and Faldaprevir soft gelatin capsules~Oral with 240 mL of water Day 1: 400 mg raltegravir twice daily and 240 mg faldaprevir twice daily (loading dose) Days 2 to 5: 400 mg raltegravir twice daily and 240 mg faldaprevir once daily Day 6: 400 mg raltegravir once daily and 240 mg faldaprevir once daily"
140696|NCT01785160|O1|Outcome|Raltegravir|"Raltegravir coated tablets~Oral with 240 mL of water Days 1 to 3: 400 mg raltegravir twice daily Day 4: 400 mg raltegravir once daily"
140697|NCT01785160|E2|Reported Event|Raltegravir + Faldaprevir|"coated tablets and soft gelatine capsule, oral administration with 240 ml water~Raltegravir: low dose oral administration~Faldaprevir: medium dose oral administration"
140698|NCT01785160|E1|Reported Event|Raltegravir|"coated tablets, oral administration with 240 ml water~Raltegravir: low dose oral administration"
140699|NCT01785134|B3|Baseline|Total|Total of all reporting groups
140700|NCT01785134|B2|Baseline|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
140701|NCT01785134|B1|Baseline|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
140702|NCT01785134|P2|Participant Flow|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
140703|NCT01785134|P1|Participant Flow|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
140704|NCT01785134|O2|Outcome|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
140705|NCT01785134|O1|Outcome|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
140706|NCT01785134|O2|Outcome|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
140707|NCT01785134|O1|Outcome|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
140708|NCT01785134|O2|Outcome|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
140709|NCT01785134|O1|Outcome|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
140710|NCT01785134|O2|Outcome|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
140711|NCT01785134|O1|Outcome|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
140712|NCT01785134|O2|Outcome|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
140713|NCT01785134|O1|Outcome|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
140714|NCT01785134|E2|Reported Event|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
140715|NCT01785134|E1|Reported Event|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
140716|NCT01785095|B1|Baseline|Follicle Stimulating Hormone|
140717|NCT01785095|P1|Participant Flow|Follicle Stimulation Hormone|"FSH (Follicle stimulation hormone, 75 IU/vial) will be administered to women according to their need and response assessed by the Investigator.~FSH (Follicle Stimulating Hormone)"
140718|NCT01785095|O2|Outcome|Second Cycle|Second treatment cycle after 1 month of wash out.
140719|NCT01785095|O1|Outcome|First Cycle|First treatment cycle.
140720|NCT01785095|O2|Outcome|Second Cycle|Second treatment cycle performed after 1 month of wash out.
140721|NCT01785095|O1|Outcome|First Cycle|First treatment cycle.
140722|NCT01785095|O1|Outcome|Follicle Stimulationg Hormone|
140723|NCT01785095|E1|Reported Event|Follicle Stimulating Hormone|
140724|NCT01784965|B3|Baseline|Total|Total of all reporting groups
140725|NCT01784965|B2|Baseline|Liraglutide|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~liraglutide: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg."
140726|NCT01784965|B1|Baseline|Placebo|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~Placebo: Double blinded will receive study pen with same dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three."
140727|NCT01784965|P2|Participant Flow|Liraglutide|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~Liraglutide: Double Blinded study. Participants will receive a study pen with dosing instructions: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg."
140728|NCT01784965|P1|Participant Flow|Placebo|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~Placebo: Double blinded study. Participants will receive study pen with dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three."
140729|NCT01784965|O2|Outcome|Liraglutide|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~Liraglutide: Double Blinded study. Participants will receive a study pen with dosing instructions: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg."
140730|NCT01784965|O1|Outcome|Placebo|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~Placebo: Double blinded study. Participants will receive study pen with dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three."
140731|NCT01784965|O2|Outcome|Liraglutide|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~Liraglutide: Double Blinded study. Participants will receive a study pen with dosing instructions: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg."
140732|NCT01784965|O1|Outcome|Placebo|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~Placebo: Double blinded study. Participants will receive study pen with dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three."
140733|NCT01784965|O2|Outcome|Liraglutide|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~liraglutide: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg."
140734|NCT01784965|O1|Outcome|Placebo|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~Placebo: Double blinded will receive study pen with same dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three."
140735|NCT01784965|E2|Reported Event|Placebo|0/33 0/33 0/33 0/33 0/33
140736|NCT01784965|E1|Reported Event|Liraglutide|Intolerable gastrointestinal side effects 3/35 injection site reaction 2/35 pneumonia 1/35 gallstone 1/35 fall 1/35
140737|NCT01784770|B1|Baseline|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
140738|NCT01784770|P1|Participant Flow|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
140739|NCT01784770|O1|Outcome|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
140740|NCT01784770|O1|Outcome|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
140741|NCT01784770|E1|Reported Event|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
140742|NCT01784666|B4|Baseline|Total|Total of all reporting groups
140743|NCT01784666|B3|Baseline|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the subsequent 4 weeks~Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
140744|NCT01784666|B2|Baseline|Placebo -> Isradipine|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the next 4 weeks~Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.~Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
140745|NCT01784666|B1|Baseline|Isradipine-Isradipine|"Subjects will receive isradipine in phase 1 (4 weeks) and phase 2 (4 weeks)~Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
140746|NCT01784666|P3|Participant Flow|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the subsequent 4 weeks~Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
140747|NCT01784666|P2|Participant Flow|Placebo -> Isradipine|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the next 4 weeks~Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.~Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
140748|NCT01784666|P1|Participant Flow|Isradipine-Isradipine|"Subjects will receive isradipine in phase 1 (4 weeks) and phase 2 (4 weeks)~Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
140749|NCT01784666|O3|Outcome|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the subsequent 4 weeks~Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
140750|NCT01784666|O2|Outcome|Placebo -> Isradipine|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the next 4 weeks~Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.~Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
140751|NCT01784666|O1|Outcome|Isradipine-Isradipine|"Subjects will receive isradipine in phase 1 (4 weeks) and phase 2 (4 weeks)~Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
140752|NCT01784666|E3|Reported Event|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the subsequent 4 weeks~Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
140774|NCT01784614|O3|Outcome|3.0 mg LY2624803|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
140775|NCT01784614|O2|Outcome|1.0 mg LY2624803|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
144026|NCT01772550|E2|Reported Event|18 GA Conventional Catheter - Randomized|
140753|NCT01784666|E2|Reported Event|Placebo -> Isradipine|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the next 4 weeks~Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.~Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
140754|NCT01784666|E1|Reported Event|Isradipine-Isradipine|"Subjects will receive isradipine in phase 1 (4 weeks) and phase 2 (4 weeks)~Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
140755|NCT01784614|B1|Baseline|Overall|"Single dose of 0.1 mg LY2624803 oral solution plus 1 placebo capsule, one 1.0, 3.0 or 6.0 mg LY2624803 capsule plus placebo solution administered orally in up to 2 of 4 periods or 1 placebo capsule plus placebo solution administered orally in up to 1 of 4 periods.~There was at least 7 days washout between each period."
140756|NCT01784614|P8|Participant Flow|Cohort 8|"Period 1: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.~Period 2: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 3: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 4: Single dose of 1.0 mg LY2624803 solution plus 1 placebo capsule administered orally.~There was at least 7 days washout between each period."
140757|NCT01784614|P7|Participant Flow|Cohort 7|"Period 1: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 2: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.~Period 3: Single dose of 1 placebo capsule plus placebo solution administered orally.~Period 4: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.~There was at least 7 days washout between each period."
140758|NCT01784614|P6|Participant Flow|Cohort 6|"Period 1: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 2: Single dose of 1 placebo capsule plus placebo solution administered orally.~Period 3: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.~Period 4: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.~There was at least 7 days washout between each period."
140759|NCT01784614|P5|Participant Flow|Cohort 5|"Period 1: Single dose of 1 placebo capsule plus placebo solution administered orally.~Period 2: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 3: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 4: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~There was at least 7 days washout between each period."
140760|NCT01784614|P4|Participant Flow|Cohort 4|"Period 1: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 2: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 3: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 4: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.~There was at least 7 days washout between each period."
140761|NCT01784614|P3|Participant Flow|Cohort 3|"Period 1: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 2: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 3: Single dose of 1 placebo capsule plus placebo solution administered orally.~Period 4: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.~There was at least 7 days washout between each period."
140762|NCT01784614|P2|Participant Flow|Cohort 2|"Period 1: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 2: Single dose of 1 placebo capsule plus placebo solution administered orally.~Period 3: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 4: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.~There was at least 7 days washout between each period."
140763|NCT01784614|P1|Participant Flow|Cohort 1|"Period 1: Single dose of 1 placebo capsule plus placebo solution administered orally.~Period 2: Single dose of one 1.0 milligram (mg) LY2624803 capsule plus placebo solution administered orally.~Period 3: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 4: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~There was at least 7 days washout between each period."
140764|NCT01784614|O4|Outcome|6.0 mg LY2624803|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
140765|NCT01784614|O3|Outcome|3.0 mg LY2624803|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
140766|NCT01784614|O2|Outcome|1.0 mg LY2624803|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
140767|NCT01784614|O1|Outcome|0.1 mg LY2624803|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Period 4
140768|NCT01784614|O4|Outcome|6.0 mg LY2624803|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
140769|NCT01784614|O3|Outcome|3.0 mg LY2624803|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
140770|NCT01784614|O2|Outcome|1.0 mg LY2624803|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
140771|NCT01784614|O1|Outcome|0.1 mg LY2624803|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Period 4
140772|NCT01784614|O5|Outcome|Placebo|Single dose of 1 placebo capsule plus placebo solution administered orally in Periods 1, 2 and 3.
140773|NCT01784614|O4|Outcome|6.0 mg LY2624803|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
140931|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
140776|NCT01784614|O1|Outcome|0.1 mg LY2624803|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Periods 1, 2 and 3.
140777|NCT01784614|O5|Outcome|Placebo|Single dose of 1 placebo capsule plus placebo solution administered orally in Periods 1, 2 and 3.
140778|NCT01784614|O4|Outcome|6.0 mg LY2624803|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
140779|NCT01784614|O3|Outcome|3.0 mg LY2624803|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
140780|NCT01784614|O2|Outcome|1.0 mg LY2624803|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
140781|NCT01784614|O1|Outcome|0.1 mg LY2624803|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Periods 1, 2 and 3.
140782|NCT01784614|O5|Outcome|Placebo|Single dose of 1 placebo capsule plus placebo solution administered orally in Periods 1, 2 and 3.
140783|NCT01784614|O4|Outcome|6.0 mg LY2624803|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
140784|NCT01784614|O3|Outcome|3.0 mg LY2624803|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
140785|NCT01784614|O2|Outcome|1.0 mg LY2624803|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
140786|NCT01784614|O1|Outcome|0.1 mg LY2624803|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Periods 1, 2 and 3.
140787|NCT01784614|E9|Reported Event|6 mg LY2624803 - Period 4|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4.
140788|NCT01784614|E8|Reported Event|3.0 mg LY2624803 - Period 4|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4.
140789|NCT01784614|E7|Reported Event|1.0 mg LY2624803 - Period 4|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4.
140790|NCT01784614|E6|Reported Event|0.1 mg LY2624803 - Period 4|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Period 4.
140791|NCT01784614|E5|Reported Event|Placebo - Periods 1-3|Single dose of 1 placebo capsule plus placebo solution administered orally in Periods 1, 2 and 3.
140792|NCT01784614|E4|Reported Event|6.0 mg LY2624803 - Periods 1-3|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
140793|NCT01784614|E3|Reported Event|3.0 mg LY2624803 - Periods 1-3|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
140794|NCT01784614|E2|Reported Event|1.0 mg LY2624803 - Periods 1-3|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
140795|NCT01784614|E1|Reported Event|0.1 mg LY2624803 - Periods 1-3|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Periods 1, 2 and 3.
140796|NCT01784055|B1|Baseline|Overall|All subjects
140797|NCT01784055|P1|Participant Flow|Overall|All Subjects
140798|NCT01784055|O1|Outcome|Overall|All patients
140799|NCT01784055|E1|Reported Event|Overall|All patients
140800|NCT01783938|B3|Baseline|Total|Total of all reporting groups
140801|NCT01783938|B2|Baseline|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
140802|NCT01783938|B1|Baseline|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
140803|NCT01783938|P2|Participant Flow|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
140832|NCT01783886|P3|Participant Flow|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
140833|NCT01783886|P2|Participant Flow|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
140872|NCT01783860|O2|Outcome|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
140804|NCT01783938|P1|Participant Flow|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
140805|NCT01783938|O2|Outcome|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
140806|NCT01783938|O1|Outcome|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
140807|NCT01783938|O2|Outcome|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
140808|NCT01783938|O1|Outcome|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
140809|NCT01783938|O2|Outcome|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
140810|NCT01783938|O1|Outcome|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
140834|NCT01783886|P1|Participant Flow|Intravitreal Aflibercept Injection 2Q4|Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
140835|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
140873|NCT01783860|O1|Outcome|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
140811|NCT01783938|O2|Outcome|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
140812|NCT01783938|O1|Outcome|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
140813|NCT01783938|E2|Reported Event|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
140814|NCT01783938|E1|Reported Event|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
140815|NCT01783912|B4|Baseline|Total|Total of all reporting groups
140816|NCT01783912|B3|Baseline|Motivated Smokers Comparison Group|"This arm of the project will address the following question:~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~Participants will not receive any intervention but will be consented and enrolled into this group and assessed for utilization of the tobacco quit line services."
140817|NCT01783912|B2|Baseline|Attention Control Group|"This arm of the project will address the following question:~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group?~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?~Attention Control Individual Sessions: Attention control subjects will receive four placebo individual sessions (25-30 minutes each). The session content will reemphasize group discussion of the personal health risks from smoking."
140818|NCT01783912|B1|Baseline|Cognitive/Motivational Intervention Group|"This arm of the project will address the following questions:~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Cognitive / Motivational Individual Sessions: Cognitive Motivational subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).~Nicotine Patch: Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks."
140819|NCT01783912|P3|Participant Flow|Motivated Smokers Comparison Group|"This arm of the project will address the following question:~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~Participants will not receive any intervention but will be consented and enrolled into this group and assessed for utilization of the tobacco quit line services."
140836|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
140927|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
140820|NCT01783912|P2|Participant Flow|Attention Control Group|"This arm of the project will address the following question:~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group?~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?~Attention Control Individual Sessions: Attention control subjects will receive four placebo individual sessions (25-30 minutes each). The session content will reemphasize group discussion of the personal health risks from smoking."
140821|NCT01783912|P1|Participant Flow|Cognitive/Motivational Intervention Group|"This arm of the project will address the following questions:~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Cognitive / Motivational Individual Sessions: Cognitive Motivational subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).~Nicotine Patch: Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks."
140822|NCT01783912|O3|Outcome|Motivated Smokers Comparison Group|"This arm of the project will address the following question:~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~Participants will not receive any intervention but will be consented and enrolled into this group and assessed for utilization of the tobacco quit line services."
140823|NCT01783912|O2|Outcome|Attention Control Group|"This arm of the project will address the following question:~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group?~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?~Attention Control Individual Sessions: Attention control subjects will receive four placebo individual sessions (25-30 minutes each). The session content will reemphasize group discussion of the personal health risks from smoking."
140824|NCT01783912|O1|Outcome|Cognitive/Motivational Intervention Group|"This arm of the project will address the following questions:~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Cognitive / Motivational Individual Sessions: Cognitive Motivational subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).~Nicotine Patch: Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks."
140825|NCT01783912|E3|Reported Event|Motivated Smokers Comparison Group|"This arm of the project will address the following question:~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~Participants will not receive any intervention but will be consented and enrolled into this group and assessed for utilization of the tobacco quit line services."
140826|NCT01783912|E2|Reported Event|Attention Control Group|"This arm of the project will address the following question:~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group?~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?~Attention Control Individual Sessions: Attention control subjects will receive four placebo individual sessions (25-30 minutes each). The session content will reemphasize group discussion of the personal health risks from smoking."
140827|NCT01783912|E1|Reported Event|Cognitive/Motivational Intervention Group|"This arm of the project will address the following questions:~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Cognitive / Motivational Individual Sessions: Cognitive Motivational subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).~Nicotine Patch: Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks."
140828|NCT01783886|B4|Baseline|Total|Total of all reporting groups
140829|NCT01783886|B3|Baseline|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
140830|NCT01783886|B2|Baseline|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
140831|NCT01783886|B1|Baseline|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) 2Q4 over 48 weeks.
140871|NCT01783860|O1|Outcome|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
140837|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
140838|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
140839|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
140840|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
140841|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
140842|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
140843|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
140844|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
140845|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
140846|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
140847|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
140848|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
140849|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
140850|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
140851|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
140852|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
140853|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
140854|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
140855|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
140856|NCT01783886|E3|Reported Event|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
140857|NCT01783886|E2|Reported Event|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
140858|NCT01783886|E1|Reported Event|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
140859|NCT01783860|B3|Baseline|Total|Total of all reporting groups
140860|NCT01783860|B2|Baseline|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
140861|NCT01783860|B1|Baseline|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
140862|NCT01783860|P2|Participant Flow|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
140863|NCT01783860|P1|Participant Flow|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
140864|NCT01783860|O2|Outcome|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
140865|NCT01783860|O1|Outcome|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
140866|NCT01783860|O2|Outcome|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
140867|NCT01783860|O1|Outcome|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
140868|NCT01783860|O2|Outcome|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
140869|NCT01783860|O1|Outcome|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
140870|NCT01783860|O2|Outcome|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
140874|NCT01783860|O2|Outcome|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
140875|NCT01783860|O1|Outcome|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
140876|NCT01783860|E2|Reported Event|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
140877|NCT01783860|E1|Reported Event|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
140878|NCT01783821|B3|Baseline|Total|Total of all reporting groups
140879|NCT01783821|B2|Baseline|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
140880|NCT01783821|B1|Baseline|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
140881|NCT01783821|P2|Participant Flow|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
140882|NCT01783821|P1|Participant Flow|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
140883|NCT01783821|O2|Outcome|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
140884|NCT01783821|O1|Outcome|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
140885|NCT01783821|O2|Outcome|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
140886|NCT01783821|O1|Outcome|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
140887|NCT01783821|O2|Outcome|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
140888|NCT01783821|O1|Outcome|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
140889|NCT01783821|O2|Outcome|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
140890|NCT01783821|O1|Outcome|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
140891|NCT01783821|O2|Outcome|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
140892|NCT01783821|O1|Outcome|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
140893|NCT01783821|O2|Outcome|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
140894|NCT01783821|O1|Outcome|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
140895|NCT01783821|E2|Reported Event|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
140896|NCT01783821|E1|Reported Event|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
140897|NCT01783743|B3|Baseline|Total|Total of all reporting groups
140898|NCT01783743|B2|Baseline|Intervention (Novel TT Screening Tool)|"Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing, plus a modest additional TT Training Program and Recognition Card.~TT Training Program and Recognition Card: The intervention is an additional training program on trichiasis recognition and a TT recognition card to assist community treatment assistants in recognizing TT cases and referring them to surgery."
140899|NCT01783743|B1|Baseline|Control (Usual Assessment)|Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.
140928|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
140929|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
140930|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
140900|NCT01783743|P2|Participant Flow|Intervention (Novel TT Screening Tool)|"Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing, plus a modest additional TT Training Program and Recognition Card.~TT Training Program and Recognition Card: The intervention is an additional training program on trichiasis recognition and a TT recognition card to assist community treatment assistants in recognizing TT cases and referring them to surgery."
140901|NCT01783743|P1|Participant Flow|Control (Usual Assessment)|Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.
140902|NCT01783743|O2|Outcome|Intervention (Novel TT Screening Tool)|"Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing, plus a modest additional TT Training Program and Recognition Card.~TT Training Program and Recognition Card: The intervention is an additional training program on trichiasis recognition and a TT recognition card to assist community treatment assistants in recognizing TT cases and referring them to surgery."
140903|NCT01783743|O1|Outcome|Control (Usual Assessment)|Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.
140904|NCT01783743|O2|Outcome|Intervention (Novel TT Screening Tool)|"Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing, plus a modest additional TT Training Program and Recognition Card.~TT Training Program and Recognition Card: The intervention is an additional training program on trichiasis recognition and a TT recognition card to assist community treatment assistants in recognizing TT cases and referring them to surgery."
140905|NCT01783743|O1|Outcome|Control (Usual Assessment)|Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.
140906|NCT01783743|O2|Outcome|Intervention (Novel TT Screening Tool)|"Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing, plus a modest additional TT Training Program and Recognition Card.~TT Training Program and Recognition Card: The intervention is an additional training program on trichiasis recognition and a TT recognition card to assist community treatment assistants in recognizing TT cases and referring them to surgery."
140907|NCT01783743|O1|Outcome|Control (Usual Assessment)|Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.
140908|NCT01783743|O2|Outcome|Intervention (Novel TT Screening Tool)|"Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing, plus a modest additional TT Training Program and Recognition Card.~TT Training Program and Recognition Card: The intervention is an additional training program on trichiasis recognition and a TT recognition card to assist community treatment assistants in recognizing TT cases and referring them to surgery."
140909|NCT01783743|O1|Outcome|Control (Usual Assessment)|Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.
140910|NCT01783743|O2|Outcome|Intervention (Novel TT Screening Tool)|"Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing, plus a modest additional TT Training Program and Recognition Card.~TT Training Program and Recognition Card: The intervention is an additional training program on trichiasis recognition and a TT recognition card to assist community treatment assistants in recognizing TT cases and referring them to surgery."
140911|NCT01783743|O1|Outcome|Control (Usual Assessment)|Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.
140912|NCT01783743|E2|Reported Event|Intervention (Novel TT Screening Tool)|"Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing, plus a modest additional TT Training Program and Recognition Card.~TT Training Program and Recognition Card: The intervention is an additional training program on trichiasis recognition and a TT recognition card to assist community treatment assistants in recognizing TT cases and referring them to surgery."
140913|NCT01783743|E1|Reported Event|Control (Usual Assessment)|Community treatment assistants will receive usual training, including basic background of trachoma/trichiasis recognition, drug administration and azithromycin dosing.
140914|NCT01783730|B1|Baseline|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
140915|NCT01783730|P1|Participant Flow|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
140916|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
140917|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
140918|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
140919|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
140920|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
140921|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
140922|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
140923|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
140924|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
140925|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
140926|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
164016|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
140932|NCT01783730|E1|Reported Event|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
140933|NCT01783678|B7|Baseline|Total|Total of all reporting groups
140934|NCT01783678|B6|Baseline|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
140935|NCT01783678|B5|Baseline|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
140936|NCT01783678|B4|Baseline|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
140937|NCT01783678|B3|Baseline|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
140938|NCT01783678|B2|Baseline|Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
140939|NCT01783678|B1|Baseline|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
140940|NCT01783678|P6|Participant Flow|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
140941|NCT01783678|P5|Participant Flow|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
140942|NCT01783678|P4|Participant Flow|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
140943|NCT01783678|P3|Participant Flow|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
140944|NCT01783678|P2|Participant Flow|Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
140945|NCT01783678|P1|Participant Flow|Genotype 2 Treatment-naive|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
140946|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
140947|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
140948|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
140949|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
140950|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
140951|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
140952|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
140953|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
140954|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
140955|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
140956|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
140957|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
140958|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
140959|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
140960|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
140961|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
140962|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
140963|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
140964|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
140965|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
140966|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
140967|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
140968|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
140969|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
140970|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
140971|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
140972|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
140973|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
140974|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
140975|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
140976|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
140977|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
140978|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
140979|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
140980|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
140981|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
140982|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
140983|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
140984|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
140985|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
140986|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
140987|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
140988|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
140989|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
140990|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
140991|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
164017|NCT01697696|E2|Reported Event|QAB149|75 μg once-daily
140992|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
140993|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
140994|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
140995|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
140996|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
140997|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
140998|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
140999|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
141000|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
141001|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
141002|NCT01783678|O3|Outcome|Genotype 1/3/4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1, 3, or 4 HCV coinfection
141003|NCT01783678|O2|Outcome|Genotype 2/3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 or 3 HCV coinfection
141004|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
141005|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
141006|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
141007|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
141008|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
141009|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
141010|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
141011|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
141012|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
141013|NCT01783678|E3|Reported Event|Genotype 1/3/4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1, 3, or 4 HCV coinfection
141014|NCT01783678|E2|Reported Event|Genotype 2/3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 or 3 HCV coinfection
141015|NCT01783678|E1|Reported Event|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
141016|NCT01783639|B1|Baseline|Arm 1|"Device: WIRION™ Embolic Protection System~Interventions: Carotid Artery Stent~Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices"
141017|NCT01783639|P1|Participant Flow|WIRION|"Device: WIRION™ Embolic Protection System~Interventions: Carotid Artery Stent~Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices"
141018|NCT01783639|O1|Outcome|Arm 1|"Device: WIRION™ Embolic Protection System~Interventions: Carotid Artery Stent~Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices"
141019|NCT01783639|E1|Reported Event|WIRION|"Device: WIRION™ Embolic Protection System~Interventions: Carotid Artery Stent~Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices"
141020|NCT01783574|B3|Baseline|Total|Total of all reporting groups
141075|NCT01783496|O3|Outcome|Pattern Tip Group 2|Treatment with the Thermage CPT Pattern tip
141021|NCT01783574|B2|Baseline|Placebo|"Placebo cream will appear identical to the testosterone cream and will be applied to skin for 8 weeks.~Placebo"
141022|NCT01783574|B1|Baseline|Testosterone|"Testosterone cream will be applied to skin for 8 weeks. Starting dose is 10 mg daily and will be titrated based on blood levels.~Testosterone"
141023|NCT01783574|P2|Participant Flow|Placebo|"Placebo cream will appear identical to the testosterone cream and will be applied to skin for 8 weeks.~Placebo"
141024|NCT01783574|P1|Participant Flow|Testosterone|"Testosterone cream will be applied to skin for 8 weeks. Starting dose is 10 mg daily and will be titrated based on blood levels.~Testosterone"
141025|NCT01783574|O2|Outcome|Placebo|"Placebo cream will appear identical to the testosterone cream and will be applied to skin for 8 weeks.~Placebo"
141026|NCT01783574|O1|Outcome|Testosterone|"Testosterone cream will be applied to skin for 8 weeks. Starting dose is 10 mg daily and will be titrated based on blood levels.~Testosterone"
141027|NCT01783574|O2|Outcome|Placebo|"Placebo cream will appear identical to the testosterone cream and will be applied to skin for 8 weeks.~Placebo"
141028|NCT01783574|O1|Outcome|Testosterone|"Testosterone cream will be applied to skin for 8 weeks. Starting dose is 10 mg daily and will be titrated based on blood levels.~Testosterone"
141029|NCT01783574|O2|Outcome|Placebo|"Placebo cream will appear identical to the testosterone cream and will be applied to skin for 8 weeks.~Placebo"
141030|NCT01783574|O1|Outcome|Testosterone|"Testosterone cream will be applied to skin for 8 weeks. Starting dose is 10 mg daily and will be titrated based on blood levels.~Testosterone"
141031|NCT01783574|E2|Reported Event|Placebo|"Placebo cream will appear identical to the testosterone cream and will be applied to skin for 8 weeks.~Placebo"
141032|NCT01783574|E1|Reported Event|Testosterone|"Testosterone cream will be applied to skin for 8 weeks. Starting dose is 10 mg daily and will be titrated based on blood levels.~Testosterone"
141033|NCT01783561|B3|Baseline|Total|Total of all reporting groups
141034|NCT01783561|B2|Baseline|Routine Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. If the infant is in the routine caffeine group, the blinded drug will be placebo in the DR and IV caffeine citrate 20mg/kg at 12 hours of life.~Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
141035|NCT01783561|B1|Baseline|Early Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 15 minutes within the first 2 hours of life. If the infant is in the early caffeine group, the blinded drug will be IV caffeine citrate 20mg/kg in the first 2 hours and placebo at 12 hours of life.~Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
141036|NCT01783561|P2|Participant Flow|Routine Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. If the infant is in the routine caffeine group, the blinded drug will be placebo in the DR and IV caffeine citrate 20mg/kg at 12 hours of life.~Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
141037|NCT01783561|P1|Participant Flow|Early Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 15 minutes within the first 2 hours of life. If the infant is in the early caffeine group, the blinded drug will be IV caffeine citrate 20mg/kg in the first 2 hours and placebo at 12 hours of life.~Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
141038|NCT01783561|O2|Outcome|Routine Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. If the infant is in the routine caffeine group, the blinded drug will be placebo in the DR and IV caffeine citrate 20mg/kg at 12 hours of life.~Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
141039|NCT01783561|O1|Outcome|Early Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 15 minutes within the first 2 hours of life. If the infant is in the early caffeine group, the blinded drug will be IV caffeine citrate 20mg/kg in the first 2 hours and placebo at 12 hours of life.~Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
141040|NCT01783561|O2|Outcome|Routine Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. If the infant is in the routine caffeine group, the blinded drug will be placebo in the DR and IV caffeine citrate 20mg/kg at 12 hours of life.~Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
141076|NCT01783496|O2|Outcome|Pattern Tip|Treatment with the Thermage CPT Pattern Tip
141077|NCT01783496|O1|Outcome|Framed Tip|Treatment with Thermage CPT Framed Tip
144027|NCT01772550|E1|Reported Event|20 GA BD Nexiva Diffusics - Randomized|
141041|NCT01783561|O1|Outcome|Early Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 15 minutes within the first 2 hours of life. If the infant is in the early caffeine group, the blinded drug will be IV caffeine citrate 20mg/kg in the first 2 hours and placebo at 12 hours of life.~Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
141042|NCT01783561|E2|Reported Event|Routine Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. If the infant is in the routine caffeine group, the blinded drug will be placebo in the DR and IV caffeine citrate 20mg/kg at 12 hours of life.~Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
141043|NCT01783561|E1|Reported Event|Early Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 15 minutes within the first 2 hours of life. If the infant is in the early caffeine group, the blinded drug will be IV caffeine citrate 20mg/kg in the first 2 hours and placebo at 12 hours of life.~Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
141044|NCT01783548|B3|Baseline|Total|Total of all reporting groups
141045|NCT01783548|B2|Baseline|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
141046|NCT01783548|B1|Baseline|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
141047|NCT01783548|P2|Participant Flow|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
141048|NCT01783548|P1|Participant Flow|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
141049|NCT01783548|O2|Outcome|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
141050|NCT01783548|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
141051|NCT01783548|O2|Outcome|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
141052|NCT01783548|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
141053|NCT01783548|O2|Outcome|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
141054|NCT01783548|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
141055|NCT01783548|O2|Outcome|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
141056|NCT01783548|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
141057|NCT01783548|E2|Reported Event|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
141058|NCT01783548|E1|Reported Event|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
141059|NCT01783496|B7|Baseline|Total|Total of all reporting groups
141060|NCT01783496|B6|Baseline|Total and Patterned Tip|Split face treatment with the Thermage CPT Total and Patterned tips
141061|NCT01783496|B5|Baseline|Framed and Patterned Tip|Split face treatment with the Thermage CPT Framed and Patterned tips
141062|NCT01783496|B4|Baseline|Total Tip|Treatment with the Thermage CPT Total tip
141063|NCT01783496|B3|Baseline|Pattern Tip Group 2|Treatment with the Thermage CPT Pattern tip
141064|NCT01783496|B2|Baseline|Pattern Tip|Treatment with the Thermage CPT Pattern Tip
141065|NCT01783496|B1|Baseline|Framed Tip|Treatment with Thermage CPT Framed Tip
141066|NCT01783496|P6|Participant Flow|Total and Patterned Tip|Split face treatment with the Thermage CPT Total and Patterned tips
141067|NCT01783496|P5|Participant Flow|Framed and Patterned Tip|Split face treatment with the Thermage CPT Framed and Patterned tips
141068|NCT01783496|P4|Participant Flow|Total Tip|Treatment with the Thermage CPT Total tip
141069|NCT01783496|P3|Participant Flow|Pattern Tip Group 2|Treatment with the Thermage CPT Pattern tip Using Staggered-Pass Technique
141070|NCT01783496|P2|Participant Flow|Pattern Tip|Treatment with the Thermage CPT Pattern Tip Using Super-Pass Technique
141071|NCT01783496|P1|Participant Flow|Framed Tip|Treatment with Thermage CPT Framed Tip
141072|NCT01783496|O6|Outcome|Total and Patterned Tip|Split face treatment with the Thermage CPT Total and Patterned tips
141073|NCT01783496|O5|Outcome|Framed and Patterned Tip|Split face treatment with the Thermage CPT Framed and Patterned tips
141074|NCT01783496|O4|Outcome|Total Tip|Treatment with the Thermage CPT Total tip
141078|NCT01783496|O6|Outcome|Total and Patterned Tip|Split face treatment with the Thermage CPT Total and Patterned tips
141079|NCT01783496|O5|Outcome|Framed and Patterned Tip|Split face treatment with the Thermage CPT Framed and Patterned tips
141080|NCT01783496|O4|Outcome|Total Tip|Treatment with the Thermage CPT Total tip
141081|NCT01783496|O3|Outcome|Pattern Tip Group 2|Treatment with the Thermage CPT Pattern tip
141082|NCT01783496|O2|Outcome|Pattern Tip|Treatment with the Thermage CPT Pattern Tip
141083|NCT01783496|O1|Outcome|Framed Tip|Treatment with Thermage CPT Framed Tip
141084|NCT01783496|O6|Outcome|Total and Patterned Tip|Split face treatment with the Thermage CPT Total and Patterned tips
141085|NCT01783496|O5|Outcome|Framed and Patterned Tip|Split face treatment with the Thermage CPT Framed and Patterned tips
141086|NCT01783496|O4|Outcome|Total Tip|Treatment with the Thermage CPT Total tip
141087|NCT01783496|O3|Outcome|Pattern Tip Group 2|Treatment with the Thermage CPT Pattern tip
141088|NCT01783496|O2|Outcome|Pattern Tip|Treatment with the Thermage CPT Pattern Tip
141089|NCT01783496|O1|Outcome|Framed Tip|Treatment with Thermage CPT Framed Tip
141090|NCT01783496|E6|Reported Event|Total and Patterned Tip|"Split face treatment with the Thermage CPT Total and Patterned tips~Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
141091|NCT01783496|E5|Reported Event|Framed and Patterned Tip|"Split face treatment with the Thermage CPT Framed and Patterned tips~Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
141092|NCT01783496|E4|Reported Event|Total Tip|"Treatment with the Thermage CPT Total tip~Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
141093|NCT01783496|E3|Reported Event|Pattern Tip Group 2|"Treatment with the Thermage CPT Pattern tip~Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
141094|NCT01783496|E2|Reported Event|Pattern Tip|"Treatment with the Thermage CPT Pattern Tip~Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
141095|NCT01783496|E1|Reported Event|Framed Tip|"Treatment with Thermage CPT Framed Tip~Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
141096|NCT01783483|B3|Baseline|Total|Total of all reporting groups
141097|NCT01783483|B2|Baseline|SternaLock Blu Sternal Closure System|"Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 X plates on the sternal body and 1 L plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body.~SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based"
141098|NCT01783483|B1|Baseline|Suture Wire|"The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.).~Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy."
141099|NCT01783483|P2|Participant Flow|SternaLock Blu Closure System|"Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 X plates on the sternal body and 1 L plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body.~SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based"
141100|NCT01783483|P1|Participant Flow|Suture Wire|"The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.).~Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy."
141101|NCT01783483|O2|Outcome|SternaLock Blu Closure System|"Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 X plates on the sternal body and 1 L plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body.~SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based"
141102|NCT01783483|O1|Outcome|Suture Wire|"The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.).~Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy."
141103|NCT01783483|O2|Outcome|SternaLock Blu Closure System|"Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 X plates on the sternal body and 1 L plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body.~SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based"
141104|NCT01783483|O1|Outcome|Suture Wire|"The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.).~Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy."
141105|NCT01783483|O2|Outcome|SternaLock Blu Closure System|"Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 X plates on the sternal body and 1 L plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body.~SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based"
141106|NCT01783483|O1|Outcome|Suture Wire|"The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.).~Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy."
141107|NCT01783483|O2|Outcome|SternaLock Blu Closure System|"Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 X plates on the sternal body and 1 L plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body.~SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based"
141108|NCT01783483|O1|Outcome|Suture Wire|"The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.).~Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy."
141109|NCT01783483|O2|Outcome|SternaLock Blu Closure System|"Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 X plates on the sternal body and 1 L plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body.~SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based"
141110|NCT01783483|O1|Outcome|Suture Wire|"The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.).~Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy."
141111|NCT01783483|O2|Outcome|SternaLock Blu Closure System|"Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 X plates on the sternal body and 1 L plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body.~SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based"
141112|NCT01783483|O1|Outcome|Suture Wire|"The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.).~Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy."
141113|NCT01783483|O2|Outcome|SternaLock Blu Closure System|"Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 X plates on the sternal body and 1 L plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body.~SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based"
141114|NCT01783483|O1|Outcome|Suture Wire|"The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.).~Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy."
141115|NCT01783483|O2|Outcome|SternaLock Blu Closure System|"Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 X plates on the sternal body and 1 L plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body.~SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based"
141116|NCT01783483|O1|Outcome|Suture Wire|"The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.).~Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy."
141136|NCT01783418|B2|Baseline|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
141137|NCT01783418|B1|Baseline|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
141117|NCT01783483|O2|Outcome|SternaLock Blu Closure System|"Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 X plates on the sternal body and 1 L plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body.~SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based"
141118|NCT01783483|O1|Outcome|Suture Wire|"The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.).~Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy."
141119|NCT01783483|O2|Outcome|SternaLock Blu Closure System|"Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 X plates on the sternal body and 1 L plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body.~SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based"
141120|NCT01783483|O1|Outcome|Suture Wire|"The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.).~Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy."
141121|NCT01783483|O2|Outcome|SternaLock Blu Closure System|"Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 X plates on the sternal body and 1 L plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body.~SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based"
141122|NCT01783483|O1|Outcome|Suture Wire|"The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.).~Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy."
141123|NCT01783483|O2|Outcome|SternaLock Blu Closure System|"Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 X plates on the sternal body and 1 L plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body.~SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based"
141124|NCT01783483|O1|Outcome|Suture Wire|"The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.).~Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy."
141125|NCT01783483|E2|Reported Event|SternaLock Blu Closure System|"Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 X plates on the sternal body and 1 L plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body.~SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based"
141126|NCT01783483|E1|Reported Event|Suture Wire|"The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.).~Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy."
141127|NCT01783470|B1|Baseline|All Participants|All participants randomized to placebo or drug first then received the other treatment second.
141128|NCT01783470|P2|Participant Flow|beta3-adrenergic Receptor (AR) Agonist Then Placebo|Participants administered an oral beta3-AR agonist followed by administration of the PET tracer FDG and then PET/CT scanning. On a subsequent day that was at least 48 hours later (for washout purposes) these subjects then received placebo.
141129|NCT01783470|P1|Participant Flow|Placebo Then beta3-adrenergic Receptor (AR) Agonist|Participants administered a lactose-based oral placebo followed by administration of the PET tracer FDG and then PET/CT scanning. On a subsequent day that was at least 48 hours later (for washout purposes) these subjects then received drug.
141130|NCT01783470|O2|Outcome|beta3-adrenergic Receptor (AR)|
141131|NCT01783470|O1|Outcome|Placebo|"lactose~Placebo"
141132|NCT01783470|E3|Reported Event|Mild Cold Exposure|2 hours while wearing a cooling vest with water set to 14-16 C. This arm was before randomization and had 15 participants.
141133|NCT01783470|E2|Reported Event|beta3-adrenergic Receptor Agonist|"single dose~beta3-adrenergic receptor agonist: single dose"
141134|NCT01783470|E1|Reported Event|Placebo|"lactose~Placebo"
141135|NCT01783418|B3|Baseline|Total|Total of all reporting groups
141138|NCT01783418|P2|Participant Flow|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
141139|NCT01783418|P1|Participant Flow|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
141140|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
141141|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
141142|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
141143|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
141144|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
141145|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
141146|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
141147|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
141148|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
141149|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
141150|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
141151|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
141152|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
141153|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
141154|NCT01783418|E2|Reported Event|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
141155|NCT01783418|E1|Reported Event|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
141156|NCT01783236|B3|Baseline|Total|Total of all reporting groups
141157|NCT01783236|B2|Baseline|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.~IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
141158|NCT01783236|B1|Baseline|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.~Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
141159|NCT01783236|P2|Participant Flow|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.~IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
141160|NCT01783236|P1|Participant Flow|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.~Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
141161|NCT01783236|O2|Outcome|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.~IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
141162|NCT01783236|O1|Outcome|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.~Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
141163|NCT01783236|O2|Outcome|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.~IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
141164|NCT01783236|O1|Outcome|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.~Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
141165|NCT01783236|O2|Outcome|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.~IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
141166|NCT01783236|O1|Outcome|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.~Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
141167|NCT01783236|O2|Outcome|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.~IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
141168|NCT01783236|O1|Outcome|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.~Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
141169|NCT01783236|O2|Outcome|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.~IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
141170|NCT01783236|O1|Outcome|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.~Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
141171|NCT01783236|E2|Reported Event|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.~IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
141172|NCT01783236|E1|Reported Event|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.~Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
144028|NCT01772537|B4|Baseline|Total|Total of all reporting groups
141173|NCT01783080|B1|Baseline|Behavioral Activation for Return to Work|"BA is a manualized psychotherapy with comparable efficacy to cognitive behavioral treatment and antidepressant medication for acute treatment of depression. BA has two primary foci: 1) functional analyses of cognitive and behavioral processes that involve avoidance and 2) using avoided activities to guide activity scheduling. In this study, BA's focus was shifted to target work dysfunction by activating the patient into employment-related goals. BA-W consisted of 12 50-minute weekly sessions. Conceptualizing work dysfunction as a product of avoidance patterns and low levels of positive reinforcement, the treatment addressed maladaptive coping strategies such as avoidance as maintaining work dysfunction beyond remission of symptoms. Rather than broadly activating patients, activity scheduling focused on tasks such as sending out resumes, calling for job interviews, and networking to meet potential employers.~Behavioral Activation for return to work: See Arm Description"
141174|NCT01783080|P1|Participant Flow|Behavioral Activation for Return to Work|"BA is a manualized psychotherapy with comparable efficacy to cognitive behavioral treatment and antidepressant medication for acute treatment of depression. BA has two primary foci: 1) functional analyses of cognitive and behavioral processes that involve avoidance and 2) using avoided activities to guide activity scheduling. In this study, BA's focus was shifted to target work dysfunction by activating the patient into employment-related goals. BA-W consisted of 12 50-minute weekly sessions. Conceptualizing work dysfunction as a product of avoidance patterns and low levels of positive reinforcement, the treatment addressed maladaptive coping strategies such as avoidance as maintaining work dysfunction beyond remission of symptoms. Rather than broadly activating patients, activity scheduling focused on tasks such as sending out resumes, calling for job interviews, and networking to meet potential employers.~Behavioral Activation for return to work: See Arm Description"
141175|NCT01783080|O1|Outcome|Behavioral Activation for Return to Work|"BA is a manualized psychotherapy with comparable efficacy to cognitive behavioral treatment and antidepressant medication for acute treatment of depression. BA has two primary foci: 1) functional analyses of cognitive and behavioral processes that involve avoidance and 2) using avoided activities to guide activity scheduling. In this study, BA's focus was shifted to target work dysfunction by activating the patient into employment-related goals. BA-W consisted of 12 50-minute weekly sessions. Conceptualizing work dysfunction as a product of avoidance patterns and low levels of positive reinforcement, the treatment addressed maladaptive coping strategies such as avoidance as maintaining work dysfunction beyond remission of symptoms. Rather than broadly activating patients, activity scheduling focused on tasks such as sending out resumes, calling for job interviews, and networking to meet potential employers.~Behavioral Activation for return to work: See Arm Description"
141176|NCT01783080|O1|Outcome|Behavioral Activation for Return to Work|"BA is a manualized psychotherapy with comparable efficacy to cognitive behavioral treatment and antidepressant medication for acute treatment of depression. BA has two primary foci: 1) functional analyses of cognitive and behavioral processes that involve avoidance and 2) using avoided activities to guide activity scheduling. In this study, BA's focus was shifted to target work dysfunction by activating the patient into employment-related goals. BA-W consisted of 12 50-minute weekly sessions. Conceptualizing work dysfunction as a product of avoidance patterns and low levels of positive reinforcement, the treatment addressed maladaptive coping strategies such as avoidance as maintaining work dysfunction beyond remission of symptoms. Rather than broadly activating patients, activity scheduling focused on tasks such as sending out resumes, calling for job interviews, and networking to meet potential employers.~Behavioral Activation for return to work: See Arm Description"
141177|NCT01783080|O1|Outcome|Behavioral Activation for Return to Work|"BA is a manualized psychotherapy with comparable efficacy to cognitive behavioral treatment and antidepressant medication for acute treatment of depression. BA has two primary foci: 1) functional analyses of cognitive and behavioral processes that involve avoidance and 2) using avoided activities to guide activity scheduling. In this study, BA's focus was shifted to target work dysfunction by activating the patient into employment-related goals. BA-W consisted of 12 50-minute weekly sessions. Conceptualizing work dysfunction as a product of avoidance patterns and low levels of positive reinforcement, the treatment addressed maladaptive coping strategies such as avoidance as maintaining work dysfunction beyond remission of symptoms. Rather than broadly activating patients, activity scheduling focused on tasks such as sending out resumes, calling for job interviews, and networking to meet potential employers.~Behavioral Activation for return to work: See Arm Description"
141178|NCT01783080|O1|Outcome|Behavioral Activation for Return to Work|"BA is a manualized psychotherapy with comparable efficacy to cognitive behavioral treatment and antidepressant medication for acute treatment of depression. BA has two primary foci: 1) functional analyses of cognitive and behavioral processes that involve avoidance and 2) using avoided activities to guide activity scheduling. In this study, BA's focus was shifted to target work dysfunction by activating the patient into employment-related goals. BA-W consisted of 12 50-minute weekly sessions. Conceptualizing work dysfunction as a product of avoidance patterns and low levels of positive reinforcement, the treatment addressed maladaptive coping strategies such as avoidance as maintaining work dysfunction beyond remission of symptoms. Rather than broadly activating patients, activity scheduling focused on tasks such as sending out resumes, calling for job interviews, and networking to meet potential employers.~Behavioral Activation for return to work: See Arm Description"
141179|NCT01783080|E1|Reported Event|Behavioral Activation for Return to Work|"BA is a manualized psychotherapy with comparable efficacy to cognitive behavioral treatment and antidepressant medication for acute treatment of depression. BA has two primary foci: 1) functional analyses of cognitive and behavioral processes that involve avoidance and 2) using avoided activities to guide activity scheduling. In this study, BA's focus was shifted to target work dysfunction by activating the patient into employment-related goals. BA-W consisted of 12 50-minute weekly sessions. Conceptualizing work dysfunction as a product of avoidance patterns and low levels of positive reinforcement, the treatment addressed maladaptive coping strategies such as avoidance as maintaining work dysfunction beyond remission of symptoms. Rather than broadly activating patients, activity scheduling focused on tasks such as sending out resumes, calling for job interviews, and networking to meet potential employers.~Behavioral Activation for return to work: See Arm Description"
141180|NCT01783054|B1|Baseline|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
141217|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141181|NCT01783054|P1|Participant Flow|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
141182|NCT01783054|O1|Outcome|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
141183|NCT01783054|O1|Outcome|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
141184|NCT01783054|O1|Outcome|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
141185|NCT01783054|O1|Outcome|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
141186|NCT01783054|O1|Outcome|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
141187|NCT01783054|O1|Outcome|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
141188|NCT01783054|E1|Reported Event|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
141189|NCT01783015|B3|Baseline|Total|Total of all reporting groups
141190|NCT01783015|B2|Baseline|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141191|NCT01783015|B1|Baseline|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141192|NCT01783015|P3|Participant Flow|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141193|NCT01783015|P2|Participant Flow|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141194|NCT01783015|P1|Participant Flow|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141195|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141196|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141197|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141198|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141199|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141200|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141201|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141202|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141203|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141204|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141205|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141206|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141207|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141208|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141209|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141210|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141211|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141212|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141213|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141214|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141215|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141216|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141318|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
141218|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141219|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141220|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141221|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141222|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141223|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141224|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141225|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141226|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141227|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141228|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141229|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141230|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141231|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141232|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141233|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141234|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141235|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141236|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141237|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141238|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141239|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141240|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141241|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141242|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141243|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141244|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141245|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141246|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141247|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141248|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141249|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141250|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141251|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141252|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141253|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141254|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141255|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141256|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141257|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141258|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141259|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
144029|NCT01772537|B3|Baseline|Open Repair|These patients received no intervention, just standard of care.
141260|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141261|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141262|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141263|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141264|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141265|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141266|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141267|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141268|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141269|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141270|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141271|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141272|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141273|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141274|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141275|NCT01783015|E3|Reported Event|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
141276|NCT01783015|E2|Reported Event|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
141277|NCT01783015|E1|Reported Event|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
141278|NCT01782963|B1|Baseline|Treatment Arm|"Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)~Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15~Lenalidomide~Bortezomib~Dexamethasone"
141279|NCT01782963|P1|Participant Flow|Treatment Arm|"Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)~Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15~Lenalidomide~Bortezomib~Dexamethasone"
141280|NCT01782963|O2|Outcome|Subcutaneous|"Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)~Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15~Lenalidomide"
141281|NCT01782963|O1|Outcome|Intravenous|"Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)~Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15~Lenalidomide~Bortezomib~Dexamethasone"
141282|NCT01782963|O1|Outcome|Treatment Arm|"Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)~Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15~Lenalidomide~Bortezomib~Dexamethasone"
141283|NCT01782963|O1|Outcome|Treatment Arm|"Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)~Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15~Lenalidomide~Bortezomib~Dexamethasone"
141284|NCT01782963|O1|Outcome|Treatment Arm|"Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)~Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15~Lenalidomide~Bortezomib~Dexamethasone"
141285|NCT01782963|O1|Outcome|Treatment Arm|"Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)~Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15~Lenalidomide~Bortezomib~Dexamethasone"
141286|NCT01782963|E1|Reported Event|Treatment Arm|"Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)~Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15~Lenalidomide~Bortezomib~Dexamethasone"
141287|NCT01782898|B3|Baseline|Total|Total of all reporting groups
141319|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
141288|NCT01782898|B2|Baseline|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,~Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
141289|NCT01782898|B1|Baseline|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min~Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
141290|NCT01782898|P2|Participant Flow|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,~Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
141291|NCT01782898|P1|Participant Flow|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min~Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
141292|NCT01782898|O2|Outcome|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,~Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
141293|NCT01782898|O1|Outcome|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min~Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
141294|NCT01782898|O2|Outcome|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,~Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
141295|NCT01782898|O1|Outcome|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min~Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
141296|NCT01782898|O2|Outcome|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,~Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
141297|NCT01782898|O1|Outcome|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min~Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
141298|NCT01782898|E2|Reported Event|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,~Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
141299|NCT01782898|E1|Reported Event|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min~Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
141300|NCT01782885|B3|Baseline|Total|Total of all reporting groups
141301|NCT01782885|B2|Baseline|Intra-articular Injection of PRP|Intra-articular injection of PRP: Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks treatment).
141302|NCT01782885|B1|Baseline|Acetaminophen|Patients from this arm will receive a dosis of acetaminophen (500 mg/8 hours) during 6 weeks.
141303|NCT01782885|P2|Participant Flow|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
141304|NCT01782885|P1|Participant Flow|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
141305|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
141306|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
141307|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
141308|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
141309|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
141310|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
141311|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
141312|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
141313|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
141314|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
141315|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
141316|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
141317|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
141320|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
141321|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
141322|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
141323|NCT01782885|E2|Reported Event|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
141324|NCT01782885|E1|Reported Event|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
141325|NCT01782872|B5|Baseline|Total|Total of all reporting groups
141326|NCT01782872|B4|Baseline|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
141327|NCT01782872|B3|Baseline|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
141328|NCT01782872|B2|Baseline|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
141329|NCT01782872|B1|Baseline|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
141330|NCT01782872|P4|Participant Flow|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
141331|NCT01782872|P3|Participant Flow|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
141332|NCT01782872|P2|Participant Flow|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
141333|NCT01782872|P1|Participant Flow|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
141334|NCT01782872|O4|Outcome|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
141335|NCT01782872|O3|Outcome|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
141336|NCT01782872|O2|Outcome|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
141337|NCT01782872|O1|Outcome|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
141338|NCT01782872|O4|Outcome|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
141339|NCT01782872|O3|Outcome|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
141340|NCT01782872|O2|Outcome|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
141341|NCT01782872|O1|Outcome|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
141342|NCT01782872|O4|Outcome|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
141343|NCT01782872|O3|Outcome|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
141344|NCT01782872|O2|Outcome|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
141345|NCT01782872|O1|Outcome|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
141346|NCT01782872|O4|Outcome|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
141347|NCT01782872|O3|Outcome|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
141348|NCT01782872|O2|Outcome|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
141349|NCT01782872|O1|Outcome|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
141350|NCT01782872|E4|Reported Event|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
141351|NCT01782872|E3|Reported Event|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
141352|NCT01782872|E2|Reported Event|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
141353|NCT01782872|E1|Reported Event|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
141354|NCT01782859|B3|Baseline|Total|Total of all reporting groups
141355|NCT01782859|B2|Baseline|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
141356|NCT01782859|B1|Baseline|Placebo|"Control group~Placebo (for Prednisone)"
141357|NCT01782859|P2|Participant Flow|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
141358|NCT01782859|P1|Participant Flow|Placebo|"Control group~Placebo (for Prednisone)"
141359|NCT01782859|O2|Outcome|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV~Prednisone~Hydrocortisone"
141360|NCT01782859|O1|Outcome|Placebo|"Control group~Placebo (for Prednisone)"
141361|NCT01782859|O2|Outcome|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
141362|NCT01782859|O1|Outcome|Placebo|"Control group~Placebo (for Prednisone)"
141363|NCT01782859|O2|Outcome|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
141364|NCT01782859|O1|Outcome|Placebo|"Control group~Placebo (for Prednisone)"
141365|NCT01782859|O2|Outcome|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
141366|NCT01782859|O1|Outcome|Placebo|"Control group~Placebo (for Prednisone)"
141367|NCT01782859|O2|Outcome|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
141368|NCT01782859|O1|Outcome|Placebo|"Control group~Placebo (for Prednisone)"
141369|NCT01782859|E2|Reported Event|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
141370|NCT01782859|E1|Reported Event|Placebo|"Control group~Placebo (for Prednisone)"
141371|NCT01782742|B3|Baseline|Total|Total of all reporting groups
141372|NCT01782742|B2|Baseline|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
141373|NCT01782742|B1|Baseline|Bexarotene Treatment Arm|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
141374|NCT01782742|P2|Participant Flow|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
141375|NCT01782742|P1|Participant Flow|Bexarotene Treatment Arm|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
141376|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
141377|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
141378|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
141379|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
141380|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
141381|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
141382|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
141383|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
141384|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
141385|NCT01782742|O2|Outcome|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
141386|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
141387|NCT01782742|O2|Outcome|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
141388|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
141389|NCT01782742|O2|Outcome|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
141390|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
141391|NCT01782742|O2|Outcome|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
141392|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
141393|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
141394|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
141395|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
141396|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
141397|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
141398|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
141399|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
141400|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
141401|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
141402|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
141403|NCT01782742|O2|Outcome|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
141404|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
141405|NCT01782742|E2|Reported Event|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
141406|NCT01782742|E1|Reported Event|Bexarotene Treatment Arm|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
141407|NCT01782664|B7|Baseline|Total|Total of all reporting groups
141408|NCT01782664|B6|Baseline|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141409|NCT01782664|B5|Baseline|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141410|NCT01782664|B4|Baseline|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141411|NCT01782664|B3|Baseline|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141412|NCT01782664|B2|Baseline|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141413|NCT01782664|B1|Baseline|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
141414|NCT01782664|P6|Participant Flow|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141415|NCT01782664|P5|Participant Flow|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141416|NCT01782664|P4|Participant Flow|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141417|NCT01782664|P3|Participant Flow|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141418|NCT01782664|P2|Participant Flow|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141419|NCT01782664|P1|Participant Flow|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
141420|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141421|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141422|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141423|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141424|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141425|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
141426|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141427|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141428|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141429|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141430|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141431|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
141432|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141433|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141434|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141435|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141436|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141437|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
141438|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141439|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141440|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141441|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141442|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141443|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
141444|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141445|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141446|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141447|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141448|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141449|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
141450|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141451|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141452|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141453|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141454|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141455|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
141456|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141457|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141458|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141459|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141460|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141461|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
144914|NCT01768117|O1|Outcome|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
141462|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141463|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141464|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141465|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141466|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141467|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
141468|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141469|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141470|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141471|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141472|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141473|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
141474|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141475|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141476|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141477|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141478|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141479|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
141480|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141481|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141482|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141483|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141484|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141485|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
141486|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141487|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141488|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141489|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141490|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141491|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
141492|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141493|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141494|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141495|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141496|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141497|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
141498|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141499|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141500|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141501|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141502|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141503|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
144915|NCT01768117|E1|Reported Event|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
141504|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141505|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141506|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141507|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141508|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141509|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
141510|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141511|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141512|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141513|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141514|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141515|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
141516|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141517|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141518|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141519|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141520|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141521|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
141522|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141523|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141524|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141525|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141526|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141527|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
141528|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141529|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141530|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141531|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141532|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141533|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
141534|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141535|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141536|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141537|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141538|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141539|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
141540|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141541|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141542|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141543|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141544|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141545|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
145318|NCT01766713|E1|Reported Event|Ezetimibe|"10 mg/day of Ezetimibe~Ezetimibe"
141546|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141547|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141548|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141549|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141550|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141551|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
141552|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141553|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141554|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141555|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141556|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141557|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
141558|NCT01782664|E6|Reported Event|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141559|NCT01782664|E5|Reported Event|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141560|NCT01782664|E4|Reported Event|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141561|NCT01782664|E3|Reported Event|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141562|NCT01782664|E2|Reported Event|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
141563|NCT01782664|E1|Reported Event|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
141564|NCT01782495|B12|Baseline|Total|Total of all reporting groups
141565|NCT01782495|B11|Baseline|Arm K|Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141566|NCT01782495|B10|Baseline|Arm J|Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141567|NCT01782495|B9|Baseline|Arm I|Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
141568|NCT01782495|B8|Baseline|Arm H|Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141569|NCT01782495|B7|Baseline|Arm G|Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
141570|NCT01782495|B6|Baseline|Arm F|Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141571|NCT01782495|B5|Baseline|Arm E|Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141572|NCT01782495|B4|Baseline|Arm D|Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141573|NCT01782495|B3|Baseline|Arm C|Liver transplant receipts with HCV genotype 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks.
141574|NCT01782495|B2|Baseline|Arm B|Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141575|NCT01782495|B1|Baseline|Arm A|Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141576|NCT01782495|P11|Participant Flow|Arm K|Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141577|NCT01782495|P10|Participant Flow|Arm J|Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141653|NCT01782469|B1|Baseline|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
141578|NCT01782495|P9|Participant Flow|Arm I|Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
141579|NCT01782495|P8|Participant Flow|Arm H|Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141580|NCT01782495|P7|Participant Flow|Arm G|Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
141581|NCT01782495|P6|Participant Flow|Arm F|Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141582|NCT01782495|P5|Participant Flow|Arm E|Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141583|NCT01782495|P4|Participant Flow|Arm D|Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141584|NCT01782495|P3|Participant Flow|Arm C|Liver transplant receipts with HCV 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks.
141585|NCT01782495|P2|Participant Flow|Arm B|Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141586|NCT01782495|P1|Participant Flow|Arm A|Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141587|NCT01782495|O11|Outcome|Arm K|Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141588|NCT01782495|O10|Outcome|Arm J|Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141589|NCT01782495|O9|Outcome|Arm I|Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
141590|NCT01782495|O8|Outcome|Arm H|Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141591|NCT01782495|O7|Outcome|Arm G|Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
141592|NCT01782495|O6|Outcome|Arm F|Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141593|NCT01782495|O5|Outcome|Arm E|Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141594|NCT01782495|O4|Outcome|Arm D|Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141595|NCT01782495|O3|Outcome|Arm C|Liver transplant receipts with HCV genotype 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks.
141596|NCT01782495|O2|Outcome|Arm B|Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141597|NCT01782495|O1|Outcome|Arm A|Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141598|NCT01782495|O11|Outcome|Arm K|Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141599|NCT01782495|O10|Outcome|Arm J|Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141600|NCT01782495|O9|Outcome|Arm I|Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
141601|NCT01782495|O8|Outcome|Arm H|Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141602|NCT01782495|O7|Outcome|Arm G|Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
141603|NCT01782495|O6|Outcome|Arm F|Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141604|NCT01782495|O5|Outcome|Arm E|Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141605|NCT01782495|O4|Outcome|Arm D|Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141606|NCT01782495|O3|Outcome|Arm C|Liver transplant receipts with HCV genotype 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks.
141607|NCT01782495|O2|Outcome|Arm B|Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141608|NCT01782495|O1|Outcome|Arm A|Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141609|NCT01782495|O11|Outcome|Arm K|Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141610|NCT01782495|O10|Outcome|Arm J|Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141611|NCT01782495|O9|Outcome|Arm I|Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
141612|NCT01782495|O8|Outcome|Arm H|Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141613|NCT01782495|O7|Outcome|Arm G|Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
141614|NCT01782495|O6|Outcome|Arm F|Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141615|NCT01782495|O5|Outcome|Arm E|Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141616|NCT01782495|O4|Outcome|Arm D|Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141617|NCT01782495|O3|Outcome|Arm C|Liver transplant receipts with HCV genotype 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks.
141618|NCT01782495|O2|Outcome|Arm B|Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141619|NCT01782495|O1|Outcome|Arm A|Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141620|NCT01782495|O11|Outcome|Arm K|Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141621|NCT01782495|O10|Outcome|Arm J|Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141622|NCT01782495|O9|Outcome|Arm I|Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
141623|NCT01782495|O8|Outcome|Arm H|Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141624|NCT01782495|O7|Outcome|Arm G|Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
141625|NCT01782495|O6|Outcome|Arm F|Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
145319|NCT01766466|B3|Baseline|Total|Total of all reporting groups
141626|NCT01782495|O5|Outcome|Arm E|Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141627|NCT01782495|O4|Outcome|Arm D|Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141628|NCT01782495|O3|Outcome|Arm C|Liver transplant receipts with HCV genotype 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks.
141629|NCT01782495|O2|Outcome|Arm B|Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141630|NCT01782495|O1|Outcome|Arm A|Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141631|NCT01782495|E11|Reported Event|ARM K|Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141632|NCT01782495|E10|Reported Event|ARM J|Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141633|NCT01782495|E9|Reported Event|ARM I|Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
141634|NCT01782495|E8|Reported Event|ARM H|Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141635|NCT01782495|E7|Reported Event|ARM G|Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
141636|NCT01782495|E6|Reported Event|ARM F|Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141637|NCT01782495|E5|Reported Event|ARM E|Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
141638|NCT01782495|E4|Reported Event|ARM D|Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141639|NCT01782495|E3|Reported Event|ARM C|Liver transplant receipts with HCV genotype 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks.
141640|NCT01782495|E2|Reported Event|ARM B|Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141641|NCT01782495|E1|Reported Event|ARM A|Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
141642|NCT01782482|B3|Baseline|Total|Total of all reporting groups
141643|NCT01782482|B2|Baseline|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
141644|NCT01782482|B1|Baseline|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
141645|NCT01782482|P2|Participant Flow|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
141646|NCT01782482|P1|Participant Flow|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
141647|NCT01782482|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
141648|NCT01782482|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
141649|NCT01782482|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
141650|NCT01782482|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
141651|NCT01782482|E2|Reported Event|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
141652|NCT01782482|E1|Reported Event|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
141654|NCT01782469|P1|Participant Flow|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
141655|NCT01782469|O1|Outcome|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
141656|NCT01782469|O1|Outcome|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
141657|NCT01782469|O1|Outcome|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
141658|NCT01782469|O1|Outcome|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
141659|NCT01782469|O1|Outcome|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
141660|NCT01782469|E1|Reported Event|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
141661|NCT01782326|B3|Baseline|Total|Total of all reporting groups
141662|NCT01782326|B2|Baseline|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141663|NCT01782326|B1|Baseline|QVA149|QVA149 (110/50 μg) once daily
141664|NCT01782326|P2|Participant Flow|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141665|NCT01782326|P1|Participant Flow|QVA149|QVA149 (110/50 μg) once daily
141666|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141667|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141668|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141669|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141670|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141671|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141672|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141673|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141674|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141675|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141676|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141677|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141678|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141679|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141680|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141681|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141682|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141683|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141684|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141685|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141686|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141687|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141688|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141689|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141690|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141691|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141692|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141693|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141694|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141695|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141696|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141697|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141698|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141699|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141700|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141701|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141702|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141703|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141704|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141705|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141706|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141707|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141708|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141709|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141710|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141711|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141712|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141713|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141714|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141715|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141716|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141717|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141718|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141719|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141720|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141721|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
141722|NCT01782326|E2|Reported Event|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
141723|NCT01782326|E1|Reported Event|QVA149|QVA149 (110/50 μg) once daily
141724|NCT01782222|B4|Baseline|Total|Total of all reporting groups
141725|NCT01782222|B3|Baseline|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
141726|NCT01782222|B2|Baseline|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
141727|NCT01782222|B1|Baseline|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
141728|NCT01782222|P3|Participant Flow|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
141729|NCT01782222|P2|Participant Flow|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
141730|NCT01782222|P1|Participant Flow|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
141731|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
141732|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
141733|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
141734|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
141735|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
141736|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
141815|NCT01781481|O2|Outcome|Subjects With MASC Scores in the Non-clinical Range|Children whose scores on the Multidimensional Anxiety Scale for Children fell below the clinical range.
141816|NCT01781481|O1|Outcome|Subjects With MASC Scores in the Clinical Range.|Children whose scores on the Multidimensional Anxiety Scale for Children fell within the clinical range.
141817|NCT01781481|O3|Outcome|Pediatric INTERMED Caregiver/Family Domain Score|Sum of Pediatric INTERMED Caregiver/Family Domain item scores
141737|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
141738|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
141739|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
141740|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
141741|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
141742|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
141743|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
141744|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
141745|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
141746|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
141747|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
141748|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
141749|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
141750|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
141751|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
141752|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
141818|NCT01781481|O2|Outcome|Pediatric INTERMED Social Domain Score|Sum of Pediatric INTERMED Social Domain items scores
147454|NCT01762345|B1|Baseline|Pessary Device|pessary (disposable intra-vaginal device)
141753|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
141754|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
141755|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
141756|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
141757|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
141758|NCT01782222|E3|Reported Event|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~Optimal dosage:~The maximum Rotigotine dose allowed was 8 mg / 24 hours or 16 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours or 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
141759|NCT01782222|E2|Reported Event|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~Optimal dosage:~The maximum Rotigotine dose allowed was 8 mg / 24 hours or 16 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours or 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
141760|NCT01782222|E1|Reported Event|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
141761|NCT01781962|B1|Baseline|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
141762|NCT01781962|P1|Participant Flow|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
141763|NCT01781962|O1|Outcome|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
141764|NCT01781962|O1|Outcome|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
141765|NCT01781962|O1|Outcome|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
141766|NCT01781962|E1|Reported Event|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
141767|NCT01781832|B1|Baseline|(ARFI)-Derived Shear Wave Velocities|"This is an new ultrasound-based technique using Acoustic Radiation Force Impulse (ARFI)-Derived Shear Wave Velocity Imaging. ARFI can be used to aid in detecting wall thickness and fibrosis in the urinary bladder of pediatric patients.~ARFI-Derived Shear Wave Velocities: This technology uses ultrasound scanning with acoustic radiation force impulse-derived (called ARFI). This technique measures shear wave velocities to obtain and analyze images of the urinary bladder. The research ultrasound scan takes 10-15 minutes to complete."
141768|NCT01781832|P1|Participant Flow|Subjects Having Urinary Testing|"Subjects were pediatric patients scheduled to have a test on their bladder called CMG (cystometrogram). CMG is an invasive test that requires insertion of a catheter (tube) into the bladder.~The patients agreed to have a research ultrasound (US) of their bladder. The US included a technique called elastography, which uses sound waves to measure the stiffness of tissue."
141769|NCT01781832|O1|Outcome|(ARFI)-Derived Shear Wave Velocities|"This is an ultrasound-based new technique using Acoustic Radiation Force Impulse (ARFI)-Derived Shear Wave Velocity Imaging. This will aid in detecting bladder wall thickness and fibrosis in the urinary bladder of pediatric patients.~ARFI-Derived Shear Wave Velocities: An ultrasound scan using acoustic radiation force impulse-derived shear wave velocities to obtain images of the urinary bladder. The research ultrasound scan l takes 15 minutes to complete. The shear wave velocity is a measure of the stiffness of the bladder wall."
141770|NCT01781832|O1|Outcome|(ARFI)-Derived Shear Wave Velocities|"This is an ultrasound-based new technique using Acoustic Radiation Force Impulse (ARFI)-Derived Shear Wave Velocity Imaging. This will aid in detecting bladder wall thickness and fibrosis in the urinary bladder of pediatric patients.~ARFI-Derived Shear Wave Velocities: An ultrasound scan using acoustic radiation force impulse-derived shear wave velocities to obtain images of the urinary bladder. The research ultrasound scan l takes 15 minutes to complete. The shear wave velocity is a measure of the stiffness of the bladder wall."
141771|NCT01781832|E1|Reported Event|(ARFI)-Derived Shear Wave Velocities|"This is an ultrasound-based new technique using Acoustic Radiation Force Impulse (ARFI)-Derived Shear Wave Velocity Imaging. This will aid in detecting bladder wall thickness and fibrosis in the urinary bladder of pediatric patients.~ARFI-Derived Shear Wave Velocities: An ultrasound based scan using acoustic radiation force impulse-derived shear wave velocities to obtain images of the urinary bladder. The research ultrasound scan will take approximately 10 to 15 minutes to complete."
141772|NCT01781806|B3|Baseline|Total|Total of all reporting groups
141819|NCT01781481|O1|Outcome|Pediatric INTERMED Psychological Domain Score|Sum of Pediatric INTERMED Psychological Domain item scores
141892|NCT01781169|P2|Participant Flow|Normal-weight Group|Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.
141773|NCT01781806|B2|Baseline|Cohort LM (PEP)|"Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.~emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued."
141774|NCT01781806|B1|Baseline|Cohort H (PrEP)|"Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).~High Risk Cohort Criteria (one or more of the following has to be met):~No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.~STI diagnosis during the last 12 months.~Previous PEP use during the last 12 months (* see exclusion criteria)~Has at least one HIV infected sexual partner for ≥4 weeks.~emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued."
141775|NCT01781806|P2|Participant Flow|Cohort LM (PEP)|"Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.~emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued."
141776|NCT01781806|P1|Participant Flow|Cohort H (PrEP)|"Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).~High Risk Cohort Criteria (one or more of the following has to be met):~No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.~STI diagnosis during the last 12 months.~Previous PEP use during the last 12 months (* see exclusion criteria)~Has at least one HIV infected sexual partner for ≥4 weeks.~emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued."
141777|NCT01781806|O2|Outcome|Cohort LM (PEP)|"Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.~emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued."
141778|NCT01781806|O1|Outcome|Cohort H (PrEP)|"Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).~High Risk Cohort Criteria (one or more of the following has to be met):~No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.~STI diagnosis during the last 12 months.~Previous PEP use during the last 12 months (* see exclusion criteria)~Has at least one HIV infected sexual partner for ≥4 weeks.~emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued."
141779|NCT01781806|O1|Outcome|Cohort H (PrEP) and Cohort LM (PEP)|Participants enrolled in Cohort H (PrEP) and Cohort LM (PEP)
141780|NCT01781806|O1|Outcome|Cohort H (PrEP)|"Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).~High Risk Cohort Criteria (one or more of the following has to be met):~No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.~STI diagnosis during the last 12 months.~Previous PEP use during the last 12 months (* see exclusion criteria)~Has at least one HIV infected sexual partner for ≥4 weeks.~emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued."
141781|NCT01781806|O2|Outcome|Cohort LM (PEP)|"Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.~emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued."
141820|NCT01781481|O7|Outcome|Vulnerability Biological Item: Complications and Life Threat|This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
141782|NCT01781806|O1|Outcome|Cohort H (PrEP)|"Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).~High Risk Cohort Criteria (one or more of the following has to be met):~No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.~STI diagnosis during the last 12 months.~Previous PEP use during the last 12 months (* see exclusion criteria)~Has at least one HIV infected sexual partner for ≥4 weeks.~emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued."
141783|NCT01781806|E2|Reported Event|Cohort LM (PEP)|"Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.~emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued."
141784|NCT01781806|E1|Reported Event|Cohort H (PrEP)|"Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).~High Risk Cohort Criteria (one or more of the following has to be met):~No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.~STI diagnosis during the last 12 months.~Previous PEP use during the last 12 months (* see exclusion criteria)~Has at least one HIV infected sexual partner for ≥4 weeks.~emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued."
141785|NCT01781637|B3|Baseline|Total|Total of all reporting groups
141786|NCT01781637|B2|Baseline|Placebo|"Patients will receive placebo.~placebo: subcutaneous injection"
141787|NCT01781637|B1|Baseline|Omalizumab Group|"Patients will receive omalizumab.~Omalizumab: subcutaneous injection"
141788|NCT01781637|P2|Participant Flow|Placebo|"Patients will receive placebo.~placebo: subcutaneous injection"
141789|NCT01781637|P1|Participant Flow|Omalizumab Group|"Patients will receive omalizumab.~Omalizumab: subcutaneous injection"
141790|NCT01781637|O2|Outcome|Placebo|"Patients will receive placebo.~placebo: subcutaneous injection"
141791|NCT01781637|O1|Outcome|Omalizumab Group|"Patients will receive omalizumab.~Omalizumab: subcutaneous injection"
141792|NCT01781637|O2|Outcome|Placebo|"Patients will receive placebo.~placebo: subcutaneous injection"
141793|NCT01781637|O1|Outcome|Omalizumab Group|"Patients will receive omalizumab.~Omalizumab: subcutaneous injection"
141794|NCT01781637|E2|Reported Event|Placebo|"Patients will receive placebo.~placebo: subcutaneous injection"
141795|NCT01781637|E1|Reported Event|Omalizumab Group|"Patients will receive omalizumab.~Omalizumab: subcutaneous injection"
141796|NCT01781481|B1|Baseline|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
141797|NCT01781481|P1|Participant Flow|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of Inflammatory Bowel Disease (IBD).
141798|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
141799|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
141800|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
141801|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
141802|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
141803|NCT01781481|O6|Outcome|Vulnerability Health System Item: Health System Impediments|This item anticipates the problems that the child/youth may encounter in the next 3-6 months in receiving the services he/she requires.
141804|NCT01781481|O5|Outcome|Current Health System Item: Coordination of Care|This item describes the extent to which the different health care providers working with the child are in contact with each other.
141805|NCT01781481|O4|Outcome|Current Health System Item: Organization of Care|This item describes the nature and organization of the health care services that the child is current receiving.
141806|NCT01781481|O3|Outcome|Historical Health System Item: Treatment Experience|This item describes the degree to which the child and family's prior health care experiences have been positive in terms of good outcomes and relationships with health care providers.
141807|NCT01781481|O2|Outcome|Historical Health System Item: Access to Health Care|This item refers to anything in the past that served as an obstacle, hindering the patient's access to healthcare.
141808|NCT01781481|O1|Outcome|Pediatric Intermed: Health System Domain Score|Sum of Pediatric INTERMED health system item scores.
141809|NCT01781481|O2|Outcome|CBCL Externalizing Score in the Non-clinical Range|Children whose scores on the CBCL Externalizing Scale fell below the clinical range.
141810|NCT01781481|O1|Outcome|CBCL Externalizing Score in the Clinical Range.|Children whose scores on the CBCL Externalizing scale fell within the clinical range.
141811|NCT01781481|O2|Outcome|CBCL Internalizing Score in the Non-clinical Range|Children's whose scores on the CBCL Internalizing Scale fell below the clinical range.
141812|NCT01781481|O1|Outcome|CBCL Internalizing Score in the Clinical Range.|Children whose scores on the CBCL Internalizing Scale fell within the clinical range.
141813|NCT01781481|O2|Outcome|Subjects With CDI Scores in the Non-clinical Range|Children whose scores on the Children's Depression Inventory fell below the clinical range.
141814|NCT01781481|O1|Outcome|Subjects With CDI Scores in the Clinical Range.|Children whose scores on the Children's Depression Inventory fell within the clinical range.
141821|NCT01781481|O6|Outcome|Current Biological Item: Therapeutic Complexity|This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.
141822|NCT01781481|O5|Outcome|Current Biological Item: Diagnostic/Therapeutic Challenge|This item refers to the presence of physical symptoms that result in current diagnostic questions or therapeutic challenges.
141823|NCT01781481|O4|Outcome|Current Biological Item: Symptom Severity|This item taps the severity/acuity of the child's current physical symptoms, and the extent to which they impact on current functioning.
141824|NCT01781481|O3|Outcome|Historical Biological Item: Diagnostic Dilemma|This item taps whether or not the child/youth has been seeking care for physical complaints across a substantial portion of their life and whether or not these complaints have been resolved.
141825|NCT01781481|O2|Outcome|Historical Biological Item: Chronicity|This item taps the extent and chronicity of child's physical health issues.
141826|NCT01781481|O1|Outcome|Pediatric INTERMED Biological Domain Score|Sum of all Pediatric INTERMED Biological domain item scores.
141827|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
141828|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
141829|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
141830|NCT01781481|O1|Outcome|Children/Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
141831|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
141832|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
141833|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
141834|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
141835|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
141836|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
141837|NCT01781481|O4|Outcome|Greater Than 5 Years|Greater than 5 years since initial IBD diagnosis.
141838|NCT01781481|O3|Outcome|1 Year-5 Years|1 - 5 years since initial IBD diagnosis.
141839|NCT01781481|O2|Outcome|6 Months-1 Year|6 months to 1 year since initial IBD diagnosis.
141840|NCT01781481|O1|Outcome|Less Than 6 Months|Less than 6 months since initial IBD diagnosis.
141841|NCT01781481|O4|Outcome|Disease Severity: Severe|Disease Severity classified as severe
141842|NCT01781481|O3|Outcome|Disease Severity: Moderate|Disease Severity classified as moderate
141843|NCT01781481|O2|Outcome|Disease Severity: Mild|Disease Severity classified as mild
141844|NCT01781481|O1|Outcome|Disease Severity: Remission/Inactive|Disease Severity classified as in remission/inactive
141845|NCT01781481|O3|Outcome|Score of 2 or 3|Rating of 2 (Moderate Vulnerability/Need for Action or Development of an Intervention Plan) on the Pediatric INTERMED item or Rating of 3 (Severe Vulnerability/Need for Immediate Action of Intensive Action/Plans).
141846|NCT01781481|O2|Outcome|Score of 1|Rating of 1 (Mild Vulnerability/Need for watchful waiting or preventive intervention) on Pediatric INTERMED item.
141847|NCT01781481|O1|Outcome|Score of 0|Rating of 0 (No Vulnerability/Need for Action) on Pediatric INTERMED Item
141848|NCT01781481|O5|Outcome|Health Service|Sum of Health Service Domain Item Scores
141849|NCT01781481|O4|Outcome|Family/Caregiver|Sum of Family/Caregiver Domain Item Scores
141850|NCT01781481|O3|Outcome|Social|Sum of Social Domain Item Scores
141851|NCT01781481|O2|Outcome|Psychological|Sum of Psychological Domain Item Scores
141852|NCT01781481|O1|Outcome|Biological|Sum of Biological Domain Item Scores
141853|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
141854|NCT01781481|E1|Reported Event|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
141855|NCT01781403|B1|Baseline|Capecitabine, Temozolomide, Radiotherapy|"The total dose of radiotherapy will be 50.4 Gy, with a daily dose of 1.8 Gy administered on 5 days of each week, comprising a total of 45 Gy to the whole pelvis, followed by a 5.4 Gy boost to the primary tumor.~The doses and schedules for capecitabine will be fixed, with only temozolomide being prescribed using a dose-escalation schedule. Capecitabine and temozolomide will be administered during radiotherapy with drug holidays (weekend break).~Temozolomide: Preoperative chemoradiotherapy with fixed dose of capecitabine and temozolomide, the dose of temozolomide will be escalated for finding MTD and RD."
141856|NCT01781403|P3|Participant Flow|Capecitabine 825mg/m^2, Temozolomide 75mg/m^2, Radiotherapy|"The total dose of radiotherapy will be 50.4 Gy, with a daily dose of 1.8 Gy administered on 5 days of each week, comprising a total of 45 Gy to the whole pelvis, followed by a 5.4 Gy boost to the primary tumor.~The doses and schedules for capecitabine will be fixed, with only temozolomide being prescribed using a dose-escalation schedule. Capecitabine and temozolomide will be administered during radiotherapy with drug holidays (weekend break).~Temozolomide: Preoperative chemoradiotherapy with fixed dose of capecitabine and temozolomide, the dose of temozolomide will be escalated for finding MTD and RD."
141857|NCT01781403|P2|Participant Flow|Capecitabine 825mg/m^2, Temozolomide 60mg/m^2, Radiotherapy|"The total dose of radiotherapy will be 50.4 Gy, with a daily dose of 1.8 Gy administered on 5 days of each week, comprising a total of 45 Gy to the whole pelvis, followed by a 5.4 Gy boost to the primary tumor.~The doses and schedules for capecitabine will be fixed, with only temozolomide being prescribed using a dose-escalation schedule. Capecitabine and temozolomide will be administered during radiotherapy with drug holidays (weekend break).~Temozolomide: Preoperative chemoradiotherapy with fixed dose of capecitabine and temozolomide, the dose of temozolomide will be escalated for finding MTD and RD."
141887|NCT01781208|O1|Outcome|Children Undergoing Diagnostic ARFI/VTQ and Fibrosis Scoring|We measured correlation between liver shear wave speed as determined by ARFI (VTQ) and liver histologic fibrosis score.
141888|NCT01781208|E1|Reported Event|All Participants|No serious or non-serious adverse events were observed during the study.
141889|NCT01781169|B3|Baseline|Total|Total of all reporting groups
141890|NCT01781169|B2|Baseline|Obese Group|
141858|NCT01781403|P1|Participant Flow|Capecitabine 825mg/m^2, Temozolomide 45mg/m^2, Radiotherapy|"The total dose of radiotherapy will be 50.4 Gy, with a daily dose of 1.8 Gy administered on 5 days of each week, comprising a total of 45 Gy to the whole pelvis, followed by a 5.4 Gy boost to the primary tumor.~The doses and schedules for capecitabine will be fixed, with only temozolomide being prescribed using a dose-escalation schedule. Capecitabine and temozolomide will be administered during radiotherapy with drug holidays (weekend break).~Temozolomide: Preoperative chemoradiotherapy with fixed dose of capecitabine and temozolomide, the dose of temozolomide will be escalated for finding MTD and RD."
141859|NCT01781403|O3|Outcome|Dose Level 3/Recommended Dose|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 75 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
141860|NCT01781403|O2|Outcome|Dose Level 2|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 60 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
141861|NCT01781403|O1|Outcome|Dose Level 1|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 45 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
141862|NCT01781403|O2|Outcome|Hypermethylated MGMT|MGMT methylation specific PCR: hypermethylated
141863|NCT01781403|O1|Outcome|Unmethylated MGMT|MGMT methylation specific PCR: unmethlyated
141864|NCT01781403|O3|Outcome|Dose Level 3/Recommended Dose|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 75 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
141865|NCT01781403|O2|Outcome|Dose Level 2|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 60 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
141866|NCT01781403|O1|Outcome|Dose Level 1|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 45 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
141867|NCT01781403|O3|Outcome|Dose Level 3/Recommended Dose|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 75 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
141868|NCT01781403|O2|Outcome|Dose Level 2|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 60 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
141869|NCT01781403|O1|Outcome|Dose Level 1|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 45 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
141870|NCT01781403|E3|Reported Event|Dose Level 3/Recommended Dose|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 75 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
141871|NCT01781403|E2|Reported Event|Dose Level 2|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 60 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
141872|NCT01781403|E1|Reported Event|Dose Level 1|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 45 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
141873|NCT01781299|B3|Baseline|Total|Total of all reporting groups
141874|NCT01781299|B2|Baseline|SurgiMend PRS|"Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.~SurgiMend PRS"
141875|NCT01781299|B1|Baseline|AlloDerm RTU|"Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.~AlloDerm RTU"
141876|NCT01781299|P2|Participant Flow|SurgiMend PRS|"Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.~SurgiMend PRS"
141877|NCT01781299|P1|Participant Flow|AlloDerm RTU|"Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.~AlloDerm RTU"
141878|NCT01781299|O2|Outcome|SurgiMend PRS|"Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.~SurgiMend PRS"
141879|NCT01781299|O1|Outcome|AlloDerm RTU|"Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.~AlloDerm RTU"
141880|NCT01781299|O2|Outcome|SurgiMend PRS|"Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.~SurgiMend PRS"
141881|NCT01781299|O1|Outcome|AlloDerm RTU|"Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.~AlloDerm RTU"
141882|NCT01781299|E2|Reported Event|SurgiMend PRS|"Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.~SurgiMend PRS"
141883|NCT01781299|E1|Reported Event|AlloDerm RTU|"Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.~AlloDerm RTU"
141884|NCT01781208|B1|Baseline|Ultrasound-based Acoustic Radiation Force Impulse (ARFI)|62 children undergoing clinically ordered ultrasound-directed percutaneous core needle liver biopsy for known or suspected (non-neoplastic) liver disease were included in this study. Subjects were between 0-18 years of age.
141885|NCT01781208|P1|Participant Flow|Ultrasound-based Acoustic Radiation Force Impulse (ARFI)|"62 children undergoing clinically ordered ultrasound-directed percutaneous core needle liver biopsy were included. Biopsy was performed for known or suspected (non-neoplastic) liver disease. (One child did not undergo a liver biopsy, so was ineligible and not included in the above total.)~The patients received an additional ultrasound for research purposes that utilized a technique known as ARFI. ARFI, or Acoustic Radiation Force Impulse, uses a transducer which directs sound waves again the liver to measure the stiffness of the tissues."
141886|NCT01781208|O2|Outcome|Children Undergoing Diagnostic ARFI/VTIQ and Fibrosis Scoring|We measured correlation between liver shear wave speed as determined by ARFI/VTIQ and liver histologic fibrosis score.
141891|NCT01781169|B1|Baseline|Normal-weight Group|
141893|NCT01781169|P1|Participant Flow|Obese Group|Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.
141894|NCT01781169|O2|Outcome|Normal-weight Group|Oral supplementation of vitamin D.
141895|NCT01781169|O1|Outcome|Obese Group|Oral supplementation of vitamin D.
141896|NCT01781169|E2|Reported Event|Obese Group|
141897|NCT01781169|E1|Reported Event|Normal-weight Group|
141898|NCT01781078|B3|Baseline|Total|Total of all reporting groups
141899|NCT01781078|B2|Baseline|Control Group|"Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups.~ImageReady System implant: Pacemaker and lead(s) implant"
141900|NCT01781078|B1|Baseline|MRI Group|"Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.~MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment~ImageReady System implant: Pacemaker and lead(s) implant"
141901|NCT01781078|P3|Participant Flow|Patients Withdrawn Prior to Randomization|Patients who consented to the study but were withdrawn prior to the randomization.
141902|NCT01781078|P2|Participant Flow|Control Group|"Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups.~ImageReady System implant: Pacemaker and lead(s) implant"
141903|NCT01781078|P1|Participant Flow|MRI Group|"Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.~MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment~ImageReady System implant: Pacemaker and lead(s) implant"
141904|NCT01781078|O1|Outcome|All Subjects Who Underwent an Implant Procedure|All subjects who underwent an implant procedure and reached 91 days of follow-up.
141905|NCT01781078|O2|Outcome|MRI Group|"Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.~MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment~ImageReady System implant: Pacemaker and lead(s) implant"
141906|NCT01781078|O1|Outcome|Control Group|"Those subjects randomized to the Control Group will not undergo study-specific MRI scan. All follow-up time requirements are the same for the two groups.~ImageReady System implant: Pacemaker and lead(s) implant"
141907|NCT01781078|O2|Outcome|Control Group|"Those subjects randomized to the Control Group will not undergo study-specific MRI scan. All follow-up time requirements are the same for the two groups.~ImageReady System implant: Pacemaker and lead(s) implant"
141908|NCT01781078|O1|Outcome|MRI Group|"Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.~MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment~ImageReady System implant: Pacemaker and lead(s) implant"
141909|NCT01781078|O1|Outcome|MRI Group|"Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.~MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment~ImageReady System implant: Pacemaker and lead(s) implant"
141910|NCT01781078|E2|Reported Event|Control Group|"Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups.~ImageReady System implant: Pacemaker and lead(s) implant"
141911|NCT01781078|E1|Reported Event|MRI Group|"Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.~MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment~ImageReady System implant: Pacemaker and lead(s) implant"
141912|NCT01781026|B1|Baseline|Vemurafenib Administration|Vemurafenib 960 mg orally, twice a day
141913|NCT01781026|P1|Participant Flow|Vemurafenib Administration|Vemurafenib 960 mg orally, twice a day
141914|NCT01781026|O1|Outcome|Vemurafenib Administration|Vemurafenib 960 mg orally, twice a day
141915|NCT01781026|E1|Reported Event|Vemurafenib Administration|Vemurafenib 960 mg orally, twice a day
141916|NCT01780987|B3|Baseline|Total|Total of all reporting groups
141917|NCT01780987|B2|Baseline|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
141918|NCT01780987|B1|Baseline|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
141919|NCT01780987|P2|Participant Flow|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
141920|NCT01780987|P1|Participant Flow|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
141921|NCT01780987|O2|Outcome|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
141922|NCT01780987|O1|Outcome|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
141992|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
141923|NCT01780987|O2|Outcome|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
141924|NCT01780987|O1|Outcome|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
141925|NCT01780987|O2|Outcome|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
141926|NCT01780987|O1|Outcome|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
141927|NCT01780987|O2|Outcome|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
141928|NCT01780987|O1|Outcome|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
141929|NCT01780987|O2|Outcome|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
141930|NCT01780987|O1|Outcome|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
141931|NCT01780987|O2|Outcome|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
141932|NCT01780987|O1|Outcome|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
141933|NCT01780987|E2|Reported Event|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
141934|NCT01780987|E1|Reported Event|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
141935|NCT01780974|B3|Baseline|Total|Total of all reporting groups
141936|NCT01780974|B2|Baseline|Lipoic Acid Plus Omega-3 Fatty Acids|Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
141937|NCT01780974|B1|Baseline|Placebo|Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
141938|NCT01780974|P2|Participant Flow|Lipoic Acid Plus Omega-3 Fatty Acids|Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
141939|NCT01780974|P1|Participant Flow|Placebo|Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
141940|NCT01780974|O2|Outcome|Lipoic Acid Plus Omega-3 Fatty Acids|"Three 1-gram fish oil concentrate capsules per day (2 caps morning, 1 cap evening) containing a daily dose of 675 mg DHA and 975 mg EPA plus 2 lipoic acid capsules per day with a daily dose of 600 mg. Capsules will be taken with food or a meal.~Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate"
141941|NCT01780974|O1|Outcome|Placebo|"Three placebo oil capsules per day (2 caps morning, 1 cap evening) + 2 placebo lipoic acid capsules per day. Capsules will be taken with food or a meal.~Placebo: placebo capsules"
141942|NCT01780974|O2|Outcome|Lipoic Acid Plus Omega-3 Fatty Acids|"Three 1-gram fish oil concentrate capsules per day (2 caps morning, 1 cap evening) containing a daily dose of 675 mg DHA and 975 mg EPA plus 2 lipoic acid capsules per day with a daily dose of 600 mg. Capsules will be taken with food or a meal.~Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate"
141943|NCT01780974|O1|Outcome|Placebo|"Three placebo oil capsules per day (2 caps morning, 1 cap evening) + 2 placebo lipoic acid capsules per day. Capsules will be taken with food or a meal.~Placebo: placebo capsules"
141944|NCT01780974|E2|Reported Event|Lipoic Acid Plus Omega-3 Fatty Acids|Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
141945|NCT01780974|E1|Reported Event|Placebo|placebo capsules
141946|NCT01780935|B3|Baseline|Total|Total of all reporting groups
141947|NCT01780935|B2|Baseline|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
141948|NCT01780935|B1|Baseline|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
141949|NCT01780935|P2|Participant Flow|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
141950|NCT01780935|P1|Participant Flow|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
141951|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
141952|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
141953|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
141954|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
141955|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
141956|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
141957|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
141958|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
141959|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
141960|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
141961|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
141962|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
141963|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
141964|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
141965|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
141966|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
141967|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
141968|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
141969|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
141970|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
142045|NCT01780870|O1|Outcome|Control Group|Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy
147455|NCT01762345|P1|Participant Flow|Pessary Device|pessary (disposable intra-vaginal device)
141971|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
141972|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
141973|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
141974|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
141975|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
141976|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
141977|NCT01780935|E2|Reported Event|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
141978|NCT01780935|E1|Reported Event|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
141979|NCT01780922|B1|Baseline|All Study Participants|All study participants: all participants received all interventions
141980|NCT01780922|P6|Participant Flow|Placebo First, Then CLEB, Then LCJC|First Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
141981|NCT01780922|P5|Participant Flow|Placebo First, Then LCJC, Then CLEB|First Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
141982|NCT01780922|P4|Participant Flow|CLEB First, Then Placebo, Then LCJC|First Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
141983|NCT01780922|P3|Participant Flow|CLEB First, Then LCJC, Then Placebo|First Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes
141984|NCT01780922|P2|Participant Flow|LCJC First, Then Placebo, Then CLEB|First Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
141985|NCT01780922|P1|Participant Flow|LCJC First, Then CLEB, Then Placebo|First Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes
141986|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
141987|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
141988|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
141989|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
141990|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
141991|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
141993|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
141994|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
141995|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
141996|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
141997|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
141998|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
141999|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142000|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142001|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142002|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142003|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142004|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142005|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142006|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142007|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142008|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142009|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142010|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142011|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142012|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142013|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142014|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142015|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142016|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142017|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142018|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142019|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142072|NCT01780584|E3|Reported Event|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
142020|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142021|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142022|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142023|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142024|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142025|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142026|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142027|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142028|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142029|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142030|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142031|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142032|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142033|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142034|NCT01780922|E3|Reported Event|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142035|NCT01780922|E2|Reported Event|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142036|NCT01780922|E1|Reported Event|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
142037|NCT01780870|B3|Baseline|Total|Total of all reporting groups
142038|NCT01780870|B2|Baseline|Weight Loss Group|"Full Meal replacement Protocol~Weight loss group (Full meal replacement products): In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase"
142039|NCT01780870|B1|Baseline|Control Group|Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy
142040|NCT01780870|P2|Participant Flow|Weight Loss Group|"Full Meal replacement Protocol~Weight loss group (Full meal replacement products): In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase"
142041|NCT01780870|P1|Participant Flow|Control Group|Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy
142042|NCT01780870|O2|Outcome|Weight Loss Group|"Full Meal replacement Protocol~Weight loss group (Full meal replacement products): In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase"
142043|NCT01780870|O1|Outcome|Control Group|Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy
142044|NCT01780870|O2|Outcome|Weight Loss Group|"Full Meal replacement Protocol~Weight loss group (Full meal replacement products): In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase"
142164|NCT01780324|B3|Baseline|Total|Total of all reporting groups
142046|NCT01780870|O2|Outcome|Weight Loss Group|"Full Meal replacement Protocol~Weight loss group (Full meal replacement products): In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase"
142047|NCT01780870|O1|Outcome|Control Group|Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy
142048|NCT01780870|E2|Reported Event|Weight Loss Group|"Full Meal replacement Protocol~Weight loss group (Full meal replacement products): In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase"
142049|NCT01780870|E1|Reported Event|Control Group|Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy
142050|NCT01780584|B4|Baseline|Total|Total of all reporting groups
142051|NCT01780584|B3|Baseline|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
142052|NCT01780584|B2|Baseline|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
142053|NCT01780584|B1|Baseline|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
142054|NCT01780584|P3|Participant Flow|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
142055|NCT01780584|P2|Participant Flow|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
142056|NCT01780584|P1|Participant Flow|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
142057|NCT01780584|O3|Outcome|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
142058|NCT01780584|O2|Outcome|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
142059|NCT01780584|O1|Outcome|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
142060|NCT01780584|O3|Outcome|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
142061|NCT01780584|O2|Outcome|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
142062|NCT01780584|O1|Outcome|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
142063|NCT01780584|O3|Outcome|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
142064|NCT01780584|O2|Outcome|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
142065|NCT01780584|O1|Outcome|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
142066|NCT01780584|O3|Outcome|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
142067|NCT01780584|O2|Outcome|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
142068|NCT01780584|O1|Outcome|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
142069|NCT01780584|O3|Outcome|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
142070|NCT01780584|O2|Outcome|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
142071|NCT01780584|O1|Outcome|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
164018|NCT01697696|E1|Reported Event|NVA237|12.5 μg twice-daily
142073|NCT01780584|E2|Reported Event|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
142074|NCT01780584|E1|Reported Event|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
142075|NCT01780545|B3|Baseline|Total|Total of all reporting groups
142076|NCT01780545|B2|Baseline|Control Arm: Arm B|"Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles.~Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.~For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles."
142077|NCT01780545|B1|Baseline|Experimental Arm: Arm A|"Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.~Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity.~Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.~For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles."
142078|NCT01780545|P2|Participant Flow|Control Arm: Arm B|"Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles.~Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.~For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles."
142079|NCT01780545|P1|Participant Flow|Experimental Arm: Arm A|"Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.~Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity.~Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.~For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles."
142080|NCT01780545|O2|Outcome|Control Arm: Arm B|"Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles.~Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.~For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles."
142081|NCT01780545|O1|Outcome|Experimental Arm: Arm A|"Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle.~OGX-427: Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.~Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Participants without documented disease progression who have discontinued from study treatment not due to toxicity related to OGX-427 can also continue to receive OGX-427 maintenance as long as they have completed disease"
142082|NCT01780545|O2|Outcome|Control Arm: Arm B|"Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles.~Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.~For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles."
142083|NCT01780545|O1|Outcome|Experimental Arm: Arm A|"Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle.~OGX-427: Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.~Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Participants without documented disease progression who have discontinued from study treatment not due to toxicity related to OGX-427 can also continue to receive OGX-427 maintenance as long as they have completed disease"
142084|NCT01780545|O2|Outcome|Hsp27 >=5.7ng/mL|Subjects with a baseline Hsp27 level >=5.7 ng/mL
142085|NCT01780545|O1|Outcome|Hsp27 <5.7ng/mL|Subjects with a baseline Hsp27 level <5.7 ng/mL
142086|NCT01780545|O2|Outcome|Control Arm: Arm B|"Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles.~Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.~For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles."
142087|NCT01780545|O1|Outcome|Experimental Arm: Arm A|"Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.~Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity.~Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.~For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles."
142088|NCT01780545|O2|Outcome|Control Arm: Arm B|"Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles.~Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.~For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles."
142089|NCT01780545|O1|Outcome|Experimental Arm: Arm A|"Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.~Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity.~Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.~For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles."
142090|NCT01780545|O2|Outcome|Control Arm: Arm B|"Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles.~Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.~For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles."
142091|NCT01780545|O1|Outcome|Experimental Arm: Arm A|"Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.~Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity.~Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.~For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles."
142092|NCT01780545|E2|Reported Event|Control Arm: Arm B|"Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles.~Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.~For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles."
142093|NCT01780545|E1|Reported Event|Experimental Arm: Arm A|"Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.~Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity.~Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.~For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles."
142094|NCT01780506|B3|Baseline|Total|Total of all reporting groups
142095|NCT01780506|B2|Baseline|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
142096|NCT01780506|B1|Baseline|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
142097|NCT01780506|P2|Participant Flow|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
142098|NCT01780506|P1|Participant Flow|E/C/F/TAF|Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) placebo tablet administered orally once daily for 144 weeks
142099|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
142100|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
142101|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
142102|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
142103|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
142104|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
142105|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
142106|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
142107|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
142108|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
142109|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
142110|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
142111|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
142112|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
142166|NCT01780324|B1|Baseline|No Lidocaine|This group will have urinary catheterization without lidocaine (per standard procedure)
142113|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
142114|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
142115|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
142116|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
142117|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
142118|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
142119|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
142120|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
142121|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
142122|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
142123|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
142124|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
142125|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
142126|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
142127|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
142128|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
142129|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
142130|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
142131|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
142132|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
142133|NCT01780506|E2|Reported Event|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
142134|NCT01780506|E1|Reported Event|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
142135|NCT01780389|B1|Baseline|Milnacipran|Open-label flexibly dosed milnacipran
142136|NCT01780389|P1|Participant Flow|Milnacipran|Open-label flexibly dosed milnacipran
142137|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
142138|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
142139|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
142140|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
142141|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
142142|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
142143|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
142144|NCT01780389|O1|Outcome|Milnacipran-Open Label|"Open-label flexibly dosed milnacipran for 12 weeks. Twice-daily dosing will be used and the typical titration schedule will be as follows:~Day 1 - 12.5 mg every morning Day 2-3 - 12.5 mg twice a day Day 4-7 - 25 mg twice a day Day 8-84 - 50 mg twice a day~Taper:~Day 85-88 - 25 mg twice a day Day 89-92 - 12.5 twice a day Day 93-96 - 12.5 mg every morning"
142145|NCT01780389|E1|Reported Event|Milnacipran|Open-label flexibly dosed milnacipran
142146|NCT01780350|B1|Baseline|ResQGARD ITD|"Subjects receive a ResQGARD ITD.~ResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel."
142147|NCT01780350|P1|Participant Flow|ResQGARD ITD|"Subjects receive a ResQGARD ITD.~ResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel."
142148|NCT01780350|O1|Outcome|ResQGARD ITD|"Subjects receive a ResQGARD ITD.~ResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel."
142149|NCT01780350|O1|Outcome|ResQGARD ITD|"Subjects receive a ResQGARD ITD.~ResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel."
142150|NCT01780350|E1|Reported Event|ResQGARD ITD|"Subjects receive a ResQGARD ITD.~ResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel."
142151|NCT01780337|B3|Baseline|Total|Total of all reporting groups
142165|NCT01780324|B2|Baseline|Lidocaine|"This group will receive intraurethral lidocaine 5 minutes prior to urethral catheterization.~Lidocaine gel"
164019|NCT01697592|B11|Baseline|Total|Total of all reporting groups
142152|NCT01780337|B2|Baseline|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Saline: Intranasal dose of saline"
142153|NCT01780337|B1|Baseline|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Oxytocin: Intranasal dose of 20 IU oxytocin"
142154|NCT01780337|P2|Participant Flow|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Saline: Intranasal dose of saline"
142155|NCT01780337|P1|Participant Flow|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Oxytocin: Intranasal dose of 20 IU oxytocin"
142156|NCT01780337|O2|Outcome|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Saline: Intranasal dose of saline"
142157|NCT01780337|O1|Outcome|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Oxytocin: Intranasal dose of 20 IU oxytocin"
142158|NCT01780337|O2|Outcome|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Saline: Intranasal dose of saline"
142159|NCT01780337|O1|Outcome|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Oxytocin: Intranasal dose of 20 IU oxytocin"
142160|NCT01780337|O2|Outcome|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Saline: Intranasal dose of saline"
142161|NCT01780337|O1|Outcome|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Oxytocin: Intranasal dose of 20 IU oxytocin"
142162|NCT01780337|E2|Reported Event|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Saline: Intranasal dose of saline"
142163|NCT01780337|E1|Reported Event|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Oxytocin: Intranasal dose of 20 IU oxytocin"
142167|NCT01780324|P2|Participant Flow|Lidocaine|"This group will receive intraurethral lidocaine 5 minutes prior to urethral catheterization.~Lidocaine gel"
142168|NCT01780324|P1|Participant Flow|No Lidocaine|This group will have urinary catheterization without lidocaine (per standard procedure)
142169|NCT01780324|O2|Outcome|Lidocaine|"This group will receive intraurethral lidocaine 5 minutes prior to urethral catheterization.~Lidocaine gel"
142170|NCT01780324|O1|Outcome|No Lidocaine|This group will have urinary catheterization without lidocaine (per standard procedure)
142171|NCT01780324|E2|Reported Event|Lidocaine|"This group will receive intraurethral lidocaine 5 minutes prior to urethral catheterization.~Lidocaine gel"
142172|NCT01780324|E1|Reported Event|No Lidocaine|This group will have urinary catheterization without lidocaine (per standard procedure)
142173|NCT01779648|B3|Baseline|Total|Total of all reporting groups
142174|NCT01779648|B2|Baseline|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
142175|NCT01779648|B1|Baseline|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
142176|NCT01779648|P2|Participant Flow|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~Alternate compression+Adjusted refill time"
142177|NCT01779648|P1|Participant Flow|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~Simultaneous compression +Fixed refill time:"
142178|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
142179|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
142180|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
142181|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
142182|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
142183|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
142184|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
142185|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
142186|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
142187|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
142188|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
142189|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
142190|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
142191|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
142192|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
142193|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
142194|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
142195|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
142196|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
142197|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
142198|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
142199|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
142200|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
142201|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
142202|NCT01779648|E2|Reported Event|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
142203|NCT01779648|E1|Reported Event|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
142204|NCT01779219|B3|Baseline|Total|Total of all reporting groups
142254|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
147456|NCT01762345|O1|Outcome|Pessary Device|pessary (disposable intra-vaginal device)
142205|NCT01779219|B2|Baseline|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).~Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
142206|NCT01779219|B1|Baseline|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.~Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with was used in all procedures."
142207|NCT01779219|P2|Participant Flow|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).~Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
142208|NCT01779219|P1|Participant Flow|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.~Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) was used in all cases."
142209|NCT01779219|O2|Outcome|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).~Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
142210|NCT01779219|O1|Outcome|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.~Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a was used in all procedures."
142211|NCT01779219|O2|Outcome|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).~Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
142212|NCT01779219|O1|Outcome|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.~Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a was used in all procedures."
142255|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
142256|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
164256|NCT01697501|O1|Outcome|"CC"|at IL28B genotype rs12979860
142213|NCT01779219|O2|Outcome|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).~Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
142214|NCT01779219|O1|Outcome|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.~Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a was used in all procedures."
142215|NCT01779219|O2|Outcome|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).~Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
142216|NCT01779219|O1|Outcome|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.~Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a was used in all procedures."
142217|NCT01779219|E2|Reported Event|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).~Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
142218|NCT01779219|E1|Reported Event|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.~Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a was used in all procedures."
142219|NCT01779167|B1|Baseline|All Patients|"Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM~Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 & 27)~Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 & 28). Lenalidomide will be initiated at a starting dose of 5 mg.~Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc)."
142220|NCT01779167|P1|Participant Flow|All Patients|"Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM~Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 & 27)~Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 & 28). Lenalidomide will be initiated at a starting dose of 5 mg.~Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc)."
142221|NCT01779167|O1|Outcome|All Patients|"Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM~Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 & 27)~Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 & 28). Lenalidomide will be initiated at a starting dose of 5 mg.~Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc)."
142257|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
142258|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
142222|NCT01779167|O1|Outcome|All Patients|"Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM~Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 & 27)~Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 & 28). Lenalidomide will be initiated at a starting dose of 5 mg.~Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc)."
142223|NCT01779167|E1|Reported Event|All Patients|"Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM~Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 & 27)~Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 & 28). Lenalidomide will be initiated at a starting dose of 5 mg.~Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc)."
142224|NCT01778985|B3|Baseline|Total|Total of all reporting groups
142225|NCT01778985|B2|Baseline|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
142226|NCT01778985|B1|Baseline|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
142227|NCT01778985|P2|Participant Flow|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
142228|NCT01778985|P1|Participant Flow|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
142229|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
142230|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
142231|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
142232|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
142233|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
142234|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
142235|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
142236|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
142237|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
142238|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
142239|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
142240|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
142241|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
142242|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
142243|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
142244|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
142245|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
142246|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
142247|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
142248|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
142249|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
142250|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
142251|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
142252|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
142253|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
147457|NCT01762345|O1|Outcome|Pessary Device|pessary (disposable intra-vaginal device)
142259|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
142260|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
142261|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
142262|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
142263|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
142264|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
142265|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
142266|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
142267|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
142268|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
142269|NCT01778985|E2|Reported Event|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
142270|NCT01778985|E1|Reported Event|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
142271|NCT01778855|B3|Baseline|Total|Total of all reporting groups
142272|NCT01778855|B2|Baseline|Hypothermia|IV t-PA and hypothermia
142273|NCT01778855|B1|Baseline|Normothermia|IV t-PA and normothermia
142274|NCT01778855|P2|Participant Flow|Hypothermia|IV t-PA and hypothermia
142275|NCT01778855|P1|Participant Flow|Normothermia|IV t-PA and normothermia
142276|NCT01778855|O2|Outcome|Hypothermia|IV t-PA and hypothermia
142277|NCT01778855|O1|Outcome|Normothermia|IV t-PA and normothermia
142278|NCT01778855|E2|Reported Event|Hypothermia|IV t-PA and hypothermia
142279|NCT01778855|E1|Reported Event|Normothermia|IV t-PA and normothermia
142280|NCT01778751|B3|Baseline|Total|Total of all reporting groups
142281|NCT01778751|B2|Baseline|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.~Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
142282|NCT01778751|B1|Baseline|Control|Veterans will receive diabetes educational materials and management per their primary provider
142283|NCT01778751|P2|Participant Flow|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.~Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
142284|NCT01778751|P1|Participant Flow|Control|Veterans will receive diabetes educational materials and management per their primary provider
142285|NCT01778751|O2|Outcome|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.~Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
142286|NCT01778751|O1|Outcome|Control|Veterans will receive diabetes educational materials and management per their primary provider
142287|NCT01778751|O2|Outcome|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.~Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
142288|NCT01778751|O1|Outcome|Control|Veterans will receive diabetes educational materials and management per their primary provider
142289|NCT01778751|O2|Outcome|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.~Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
142290|NCT01778751|O1|Outcome|Control|Veterans will receive diabetes educational materials and management per their primary provider
142291|NCT01778751|O2|Outcome|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.~Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
142292|NCT01778751|O1|Outcome|Control|Veterans will receive diabetes educational materials and management per their primary provider
142293|NCT01778751|E2|Reported Event|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.~Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
142294|NCT01778751|E1|Reported Event|Control|Veterans will receive diabetes educational materials and management per their primary provider
142295|NCT01778634|B3|Baseline|Total|Total of all reporting groups
142296|NCT01778634|B2|Baseline|Azithromycin|"Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days~Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days"
142297|NCT01778634|B1|Baseline|Placebo (5% Dextrose)|"Placebo~Placebo: D5W 10 ml/kg every 24 h x 3 days"
142298|NCT01778634|P2|Participant Flow|Azithromycin|"Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days~Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days"
142299|NCT01778634|P1|Participant Flow|Placebo (5% Dextrose)|"Placebo~Placebo: D5W 10 ml/kg every 24 h x 3 days"
142300|NCT01778634|O2|Outcome|Azithromycin|"Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days~Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days"
142301|NCT01778634|O1|Outcome|Placebo (5% Dextrose)|"Placebo~Placebo: D5W"
142302|NCT01778634|O2|Outcome|Azithromycin|"Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days~Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days"
142303|NCT01778634|O1|Outcome|Placebo (5% Dextrose)|"Placebo~Placebo: D5W 10 ml/kg every 24 h x 3 days"
142304|NCT01778634|O2|Outcome|Azithromycin|"Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days~Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days"
142305|NCT01778634|O1|Outcome|Placebo (5% Dextrose)|"Placebo~Placebo: D5W 10 ml/kg every 24 h x 3 days"
142306|NCT01778634|O2|Outcome|Azithromycin|"Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days~Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days"
142307|NCT01778634|O1|Outcome|Placebo (5% Dextrose)|"Placebo~Placebo: D5W 10 ml/kg every 24 h x 3 days"
142308|NCT01778634|O2|Outcome|Azithromycin|"Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days~Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days"
142309|NCT01778634|O1|Outcome|Placebo (5% Dextrose)|"Placebo~Placebo: D5W 10 ml/kg every 24 h x 3 days"
142310|NCT01778634|O2|Outcome|Azithromycin|"Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days~Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days"
142311|NCT01778634|O1|Outcome|Placebo (5% Dextrose)|"Placebo~Placebo: D5W 10 ml/kg every 24 h x 3 days"
142312|NCT01778634|O2|Outcome|Azithromycin|"Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days~Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days"
142313|NCT01778634|O1|Outcome|Placebo (5% Dextrose)|"Placebo~Placebo: D5W 10 ml/kg every 24 h x 3 days"
142314|NCT01778634|O2|Outcome|Azithromycin|"Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days~Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days"
142315|NCT01778634|O1|Outcome|Placebo (5% Dextrose)|"Placebo~Placebo: D5W 10 ml/kg every 24 h x 3 days"
142316|NCT01778634|O2|Outcome|Azithromycin|"Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days~Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days"
142317|NCT01778634|O1|Outcome|Placebo (5% Dextrose)|"Placebo~Placebo: D5W 10 ml/kg every 24 h x 3 days"
142318|NCT01778634|O2|Outcome|Azithromycin|"Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days~Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days"
142319|NCT01778634|O1|Outcome|Placebo (5% Dextrose)|"Placebo~Placebo: D5W 10 ml/kg every 24 h x 3 days"
142320|NCT01778634|O2|Outcome|Azithromycin|"Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days~Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days"
142321|NCT01778634|O1|Outcome|Placebo (5% Dextrose)|"Placebo~Placebo: D5W 10 ml/kg every 24 h x 3 days"
164257|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs8099917
142322|NCT01778634|O2|Outcome|Azithromycin|"Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days~Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days"
142323|NCT01778634|O1|Outcome|Placebo (5% Dextrose)|"Placebo~Placebo: D5W 10 ml/kg every 24 h x 3 days"
142324|NCT01778634|O2|Outcome|Azithromycin|"Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days~Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days"
142325|NCT01778634|O1|Outcome|Placebo (5% Dextrose)|"Placebo~Placebo: D5W 10 ml/kg every 24 h x 3 days"
142326|NCT01778634|O2|Outcome|Azithromycin|"Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days~Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days"
142327|NCT01778634|O1|Outcome|Placebo (5% Dextrose)|"Placebo~Placebo: D5W 10 ml/kg every 24 h x 3 days"
142328|NCT01778634|O2|Outcome|Azithromycin|"Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days~Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days"
142329|NCT01778634|O1|Outcome|Placebo (5% Dextrose)|"Placebo~Placebo: D5W 10 ml/kg every 24 h x 3 days"
142330|NCT01778634|O2|Outcome|Azithromycin|"Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days~Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days"
142331|NCT01778634|O1|Outcome|Placebo (5% Dextrose)|"Placebo~Placebo: D5W 10 ml/kg every 24 h x 3 days"
142332|NCT01778634|E2|Reported Event|Azithromycin|"Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days~Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days"
142333|NCT01778634|E1|Reported Event|Placebo (5% Dextrose)|"Placebo~Placebo: D5W 10 ml/kg every 24 h x 3 days"
142334|NCT01778530|B1|Baseline|TRC105 for Recurrent Glioblastoma|TRC105: Intravenous infusion.
142335|NCT01778530|P1|Participant Flow|TRC105 for Recurrent Glioblastoma|TRC105: Intravenous infusion.
142336|NCT01778530|O1|Outcome|TRC105 for Recurrent Glioblastoma|TRC105: Intravenous infusion.
142337|NCT01778530|O1|Outcome|TRC105 for Recurrent Glioblastoma|TRC105: Intravenous infusion.
142338|NCT01778530|E1|Reported Event|TRC105 for Recurrent Glioblastoma|TRC105: Intravenous infusion.
142339|NCT01778296|B1|Baseline|Surgical Flap|The neurocutaneous island flap is based on the dorsal branch of the digital nerve
142340|NCT01778296|P1|Participant Flow|Surgical Flap|The neurocutaneous island flap is based on the dorsal branch of the digital nerve
142341|NCT01778296|O1|Outcome|Surgical Flap|The neurocutaneous island flap is based on the dorsal branch of the digital nerve
142342|NCT01778296|E1|Reported Event|Surgical Flap|The neurocutaneous island flap is based on the dorsal branch of the digital nerve
142343|NCT01778127|B4|Baseline|Total|Total of all reporting groups
142344|NCT01778127|B3|Baseline|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142345|NCT01778127|B2|Baseline|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142346|NCT01778127|B1|Baseline|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142347|NCT01778127|P3|Participant Flow|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142348|NCT01778127|P2|Participant Flow|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142416|NCT01778049|O1|Outcome|Lina5 (E10)|Subjects were orally administered FDC empa 10 mg/lina 5 mg and placebo matching to empa 10 mg for 24 wk during the double-blind treatment period.
142417|NCT01778049|O4|Outcome|Plc (E25)|Subjects were orally administered empa 25 mg and matching placebo to FDC empa 25 mg/lina 5 mg for 24 wk during the double-blind treatment period.
142418|NCT01778049|O3|Outcome|Lina5 (E25)|Subjects were orally administered FDC empa 25 mg/lina 5 mg and placebo matching to empa 25 mg for 24 wk during the double-blind treatment period.
142349|NCT01778127|P1|Participant Flow|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142350|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142351|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142352|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142353|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142354|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142355|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142356|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142357|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142419|NCT01778049|O2|Outcome|Plc (E10)|Subjects were orally administered empa 10 mg and matching placebo to FDC empa 10 mg/lina 5 mg for 24 wk during the double-blind treatment period.
142420|NCT01778049|O1|Outcome|Lina5 (E10)|Subjects were orally administered FDC empa 10 mg/lina 5 mg and placebo matching to empa 10 mg for 24 wk during the double-blind treatment period.
142421|NCT01778049|E6|Reported Event|Plc (E25)|Subjects were orally administered empa 25 mg and matching placebo to FDC empa 25 mg/lina 5 mg for 24 wk during the double-blind treatment period.
142358|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142359|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142360|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142361|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142362|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142363|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142364|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142365|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142366|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142422|NCT01778049|E5|Reported Event|Lina5 (E25)|Subjects were orally administered FDC empa 25 mg/lina 5 mg and placebo matching to empa 25 mg for 24 wk during the double-blind treatment period.
142423|NCT01778049|E4|Reported Event|Plc (E10)|Subjects were orally administered empa 10 mg and matching placebo to FDC empa 10 mg/lina 5 mg for 24 wk during the double-blind treatment period.
142424|NCT01778049|E3|Reported Event|Lina5 (E10)|Subjects were orally administered FDC empa 10 mg/lina 5 mg and placebo matching to empa 10 mg for 24 wk during the double-blind treatment period.
142367|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142368|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142369|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142370|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142371|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142372|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142373|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142374|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142375|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142425|NCT01778049|E2|Reported Event|Empa 25 mg OL|Subjects were orally administered once daily empa 25 mg film-coated tablet for 16 week during OL treatment period, thereafter patients received once daily FDC Plc tablet matching to FDC empa 25 mg/lina 5 mg in addition to empa 25 mg for 1 wk during open label placebo add-on treatment period.
142606|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
142376|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142377|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142378|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142379|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142380|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142381|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142382|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142383|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142384|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142426|NCT01778049|E1|Reported Event|Empa 10 mg OL|Subjects were orally administered once daily empa 10 mg film-coated tablet for 16 wk during OL treatment period, thereafter patients received once daily fixed dose combination (FDC) placebo tablet matching to FDC empa 10 mg/lina 5 mg in addition to empa 10 mg for 1 week during open label placebo add-on treatment period.
142427|NCT01778023|B3|Baseline|Total|Total of all reporting groups
142607|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
142385|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142386|NCT01778127|E3|Reported Event|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142387|NCT01778127|E2|Reported Event|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142388|NCT01778127|E1|Reported Event|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
142389|NCT01778062|B3|Baseline|Total|Total of all reporting groups
142390|NCT01778062|B2|Baseline|Placebo|Placebo once daily
142391|NCT01778062|B1|Baseline|Indacaterol|Indacaterol 150 µg once daily
142392|NCT01778062|P2|Participant Flow|Placebo|Placebo once daily
142393|NCT01778062|P1|Participant Flow|Indacaterol|Indacaterol 150 µg once daily
142394|NCT01778062|O2|Outcome|Placebo|Placebo once daily
142395|NCT01778062|O1|Outcome|Indacaterol|Indacaterol 150 µg once daily
142396|NCT01778062|O2|Outcome|Placebo|Placebo once daily
142397|NCT01778062|O1|Outcome|Indacaterol|Indacaterol 150 µg once daily
142398|NCT01778062|O2|Outcome|Placebo|Placebo once daily
142399|NCT01778062|O1|Outcome|Indacaterol|Indacaterol 150 µg once daily
142400|NCT01778062|O2|Outcome|Placebo|Placebo once daily
142401|NCT01778062|O1|Outcome|Indacaterol|Indacaterol 150 µg once daily
142402|NCT01778062|E2|Reported Event|Placebo|Placebo
142403|NCT01778062|E1|Reported Event|Indacaterol|Indacaterol
142404|NCT01778049|B3|Baseline|Total|Total of all reporting groups
142405|NCT01778049|B2|Baseline|Empa 25 mg OL|Subjects were orally administered once daily empa 25 mg film-coated tablet for 16 week during OL treatment period, thereafter patients received once daily FDC Plc tablet matching to FDC empa 25 mg/lina 5 mg in addition to empa 25 mg for 1 wk during open label placebo add-on treatment period.
142406|NCT01778049|B1|Baseline|Empa 10 mg OL|Subjects were orally administered once daily empa 10 mg film-coated tablet for 16 wk during OL treatment period, thereafter patients received once daily fixed dose combination (FDC) placebo tablet matching to FDC empa 10 mg/lina 5 mg in addition to empa 10 mg for 1 week during open label placebo add-on treatment period.
142407|NCT01778049|P6|Participant Flow|Plc (E25)|Subjects were orally administered empa 25 mg and matching placebo to FDC empa 25 mg/lina 5 mg for 24 wk during the double-blind treatment period.
142408|NCT01778049|P5|Participant Flow|Lina5 (E25)|Subjects were orally administered FDC empa 25 mg/lina 5 mg and placebo matching to empa 25 mg for 24 wk during the double-blind treatment period.
142409|NCT01778049|P4|Participant Flow|Plc (E10)|Subjects were orally administered empa 10 mg and matching placebo to FDC empa 10 mg/lina 5 mg for 24 wk during the double-blind treatment period.
142410|NCT01778049|P3|Participant Flow|Lina5 (E10)|Subjects were orally administered FDC empa 10 mg/lina 5 mg and placebo matching to empa 10 mg for 24 wk during the double-blind treatment period.
142411|NCT01778049|P2|Participant Flow|Empa 25 mg OL|Subjects were orally administered once daily empa 25 mg film-coated tablet for 16 week during OL treatment period, thereafter patients received once daily FDC Plc tablet matching to FDC empa 25 mg/lina 5 mg in addition to empa 25 mg for 1 wk during open label placebo add-on treatment period.
142412|NCT01778049|P1|Participant Flow|Empa 10 mg OL|Subjects were orally administered once daily empa 10 mg film-coated tablet for 16 wk during OL treatment period, thereafter patients received once daily fixed dose combination (FDC) placebo tablet matching to FDC empa 10 mg/lina 5 mg in addition to empa 10 mg for 1 week during open label placebo add-on treatment period.
142413|NCT01778049|O4|Outcome|Plc (E25)|Subjects were orally administered empa 25 mg and matching placebo to FDC empa 25 mg/lina 5 mg for 24 wk during the double-blind treatment period.
142414|NCT01778049|O3|Outcome|Lina5 (E25)|Subjects were orally administered FDC empa 25 mg/lina 5 mg and placebo matching to empa 25 mg for 24 wk during the double-blind treatment period.
142415|NCT01778049|O2|Outcome|Plc (E10)|Subjects were orally administered empa 10 mg and matching placebo to FDC empa 10 mg/lina 5 mg for 24 wk during the double-blind treatment period.
147458|NCT01762345|O1|Outcome|Pessary Device|pessary (disposable intra-vaginal device)
142428|NCT01778023|B2|Baseline|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
142429|NCT01778023|B1|Baseline|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
142430|NCT01778023|P2|Participant Flow|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
142431|NCT01778023|P1|Participant Flow|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
142432|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
142433|NCT01778023|O2|Outcome|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
142434|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
142435|NCT01778023|O2|Outcome|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
142436|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
142437|NCT01778023|O2|Outcome|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
142438|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
142439|NCT01778023|O2|Outcome|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
142440|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
142441|NCT01778023|O2|Outcome|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
142442|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
142443|NCT01778023|O2|Outcome|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
142444|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
142445|NCT01778023|E2|Reported Event|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
142446|NCT01778023|E1|Reported Event|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
142447|NCT01778010|B1|Baseline|Modafinil + Cocaine|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142448|NCT01778010|P1|Participant Flow|Modafinil + Cocaine|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and underwent a dose response of smoked cocaine (0, 12, 25, and 50mg).
142449|NCT01778010|O12|Outcome|Modafinil 400mg + Cocaine 50mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142560|NCT01777776|O2|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
142450|NCT01778010|O11|Outcome|Modafinil 200mg + Cocaine 50mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142451|NCT01778010|O10|Outcome|Modafinil 0mg + Cocaine 50mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142452|NCT01778010|O9|Outcome|Modafinil 400mg + Cocaine 25mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142453|NCT01778010|O8|Outcome|Modafinil 200mg + Cocaine 25mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142454|NCT01778010|O7|Outcome|Modafinil 0mg + Cocaine 25mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142455|NCT01778010|O6|Outcome|Modafinil 400mg + Cocaine 12mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142456|NCT01778010|O5|Outcome|Modafinil 200mg + Cocaine 12mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142457|NCT01778010|O4|Outcome|Modafinil 0mg + Cocaine 12mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142458|NCT01778010|O3|Outcome|Modafinil 400mg + Cocaine 0mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142459|NCT01778010|O2|Outcome|Modafinil 200mg + Cocaine 0mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142460|NCT01778010|O1|Outcome|Modafinil 0mg + Cocaine 0mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142461|NCT01778010|O12|Outcome|Modafinil 400mg + Cocaine 50mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142462|NCT01778010|O11|Outcome|Modafinil 200mg + Cocaine 50mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142463|NCT01778010|O10|Outcome|Modafinil 0mg + Cocaine 50mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142464|NCT01778010|O9|Outcome|Modafinil 400mg + Cocaine 25mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142465|NCT01778010|O8|Outcome|Modafinil 200mg + Cocaine 25mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142466|NCT01778010|O7|Outcome|Modafinil 0mg + Cocaine 25mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142467|NCT01778010|O6|Outcome|Modafinil 400mg + Cocaine 12mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142468|NCT01778010|O5|Outcome|Modafinil 200mg + Cocaine 12mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142469|NCT01778010|O4|Outcome|Modafinil 0mg + Cocaine 12mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142470|NCT01778010|O3|Outcome|Modafinil 400mg + Cocaine 0mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142471|NCT01778010|O2|Outcome|Modafinil 200mg + Cocaine 0mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142472|NCT01778010|O1|Outcome|Modafinil 0mg + Cocaine 0mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142473|NCT01778010|O12|Outcome|Modafinil 400mg + Cocaine 50mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142474|NCT01778010|O11|Outcome|Modafinil 200mg + Cocaine 50mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142475|NCT01778010|O10|Outcome|Modafinil 0mg + Cocaine 50mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142476|NCT01778010|O9|Outcome|Modafinil 400mg + Cocaine 25mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
164258|NCT01697501|O4|Outcome|"GT+GG"|at IL28B genotype rs8099917
142477|NCT01778010|O8|Outcome|Modafinil 200mg + Cocaine 25mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142478|NCT01778010|O7|Outcome|Modafinil 0mg + Cocaine 25mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142479|NCT01778010|O6|Outcome|Modafinil 400mg + Cocaine 12mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142480|NCT01778010|O5|Outcome|Modafinil 200mg + Cocaine 12mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142481|NCT01778010|O4|Outcome|Modafinil 0mg + Cocaine 12mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142482|NCT01778010|O3|Outcome|Modafinil 400mg + Cocaine 0mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142483|NCT01778010|O2|Outcome|Modafinil 200mg + Cocaine 0mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142484|NCT01778010|O1|Outcome|Modafinil 0mg + Cocaine 0mg|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
142485|NCT01778010|E3|Reported Event|Modafinil 400 mg + Cocaine (0, 12, 25, and 50mg)|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (400 mg/day) and a dose response of four doses of smoked cocaine (0, 12, 25, and 50mg).
142486|NCT01778010|E2|Reported Event|Modafinil 200 mg + Cocaine (0, 12, 25, and 50mg)|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (200 mg/day) and a dose response of four doses of smoked cocaine (0, 12, 25, and 50mg).
142487|NCT01778010|E1|Reported Event|Modafinil 0 mg + Cocaine (0, 12, 25, and 50mg)|During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (0 mg/day) and a dose response of four doses of smoked cocaine (0, 12, 25, and 50mg).
142488|NCT01777997|B1|Baseline|FTC/RPV/TDF|"Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.~Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment."
142489|NCT01777997|P1|Participant Flow|FTC/RPV/TDF|"Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily. Participants in the primary outcome analysis were on ART for at least 24 weeks and up to 48 weeks.~Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment. Participants in exploratory analyses were on ART for at least 72 weeks and up to 96 weeks."
142490|NCT01777997|O1|Outcome|FTC/RPV/TDF|"Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.~Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment."
142491|NCT01777997|O1|Outcome|FTC/RPV/TDF|"Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.~Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment."
142492|NCT01777997|O1|Outcome|FTC/RPV/TDF|"Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.~Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment."
142493|NCT01777997|O1|Outcome|FTC/RPV/TDF|"Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.~Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment."
142494|NCT01777997|O1|Outcome|FTC/RPV/TDF|"Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.~Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment."
142495|NCT01777997|O1|Outcome|FTC/RPV/TDF|"Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.~Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment."
142496|NCT01777997|O1|Outcome|FTC/RPV/TDF|"Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.~Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment."
142497|NCT01777997|O1|Outcome|FTC/RPV/TDF|"Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.~Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment."
142498|NCT01777997|O1|Outcome|FTC/RPV/TDF|"Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.~Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment."
142499|NCT01777997|E1|Reported Event|FTC/RPV/TDF|"Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.~Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment."
142500|NCT01777945|B1|Baseline|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
142501|NCT01777945|P1|Participant Flow|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
142502|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
142503|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
142504|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
142505|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
142506|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
142507|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
142508|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
142509|NCT01777945|E1|Reported Event|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
142510|NCT01777932|B1|Baseline|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
142511|NCT01777932|P1|Participant Flow|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
142512|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
142513|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
142514|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
142515|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
142516|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
142517|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
142518|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
142519|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
142520|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
142760|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
142521|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
142522|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
142523|NCT01777932|E1|Reported Event|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
142524|NCT01777776|B5|Baseline|Total|Total of all reporting groups
142525|NCT01777776|B4|Baseline|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
142526|NCT01777776|B3|Baseline|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
142527|NCT01777776|B2|Baseline|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
142528|NCT01777776|B1|Baseline|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
142529|NCT01777776|P4|Participant Flow|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
142530|NCT01777776|P3|Participant Flow|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
142531|NCT01777776|P2|Participant Flow|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
142532|NCT01777776|P1|Participant Flow|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
142533|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
142534|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142535|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142536|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142537|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
142538|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142539|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142540|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142541|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
142542|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142543|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142544|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142545|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
142546|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142547|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142548|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142549|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
142550|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142551|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142552|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142553|NCT01777776|O3|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
142554|NCT01777776|O2|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142555|NCT01777776|O1|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142556|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
142557|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142558|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142559|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142561|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142562|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142563|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142564|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142565|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
142566|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142567|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142568|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142569|NCT01777776|O4|Outcome|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
142570|NCT01777776|O3|Outcome|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
142571|NCT01777776|O2|Outcome|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
142572|NCT01777776|O1|Outcome|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
142573|NCT01777776|O4|Outcome|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
142574|NCT01777776|O3|Outcome|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
142575|NCT01777776|O2|Outcome|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
142576|NCT01777776|O1|Outcome|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
142577|NCT01777776|O1|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
142578|NCT01777776|O2|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142761|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
142579|NCT01777776|O1|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
142580|NCT01777776|O4|Outcome|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
142581|NCT01777776|O3|Outcome|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
142582|NCT01777776|O2|Outcome|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
142583|NCT01777776|O1|Outcome|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
142584|NCT01777776|E4|Reported Event|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
142585|NCT01777776|E3|Reported Event|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
142586|NCT01777776|E2|Reported Event|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
142587|NCT01777776|E1|Reported Event|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
142588|NCT01777763|B3|Baseline|Total|Total of all reporting groups
142589|NCT01777763|B2|Baseline|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days.
142590|NCT01777763|B1|Baseline|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days.
142591|NCT01777763|P2|Participant Flow|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
142592|NCT01777763|P1|Participant Flow|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
142593|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
142594|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
142595|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
142596|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
142597|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
142598|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
142599|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
142600|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
142601|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
142602|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
142603|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
142604|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
142605|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
142762|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
142608|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
142609|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
142610|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
142611|NCT01777763|E2|Reported Event|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
142612|NCT01777763|E1|Reported Event|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
142613|NCT01777620|B3|Baseline|Total|Total of all reporting groups
142614|NCT01777620|B2|Baseline|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
142615|NCT01777620|B1|Baseline|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
142616|NCT01777620|P2|Participant Flow|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
142617|NCT01777620|P1|Participant Flow|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
142618|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
142619|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
142620|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
142621|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
142622|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
142623|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
142624|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
142625|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
142626|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
142627|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
142628|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
142629|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
142630|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
142631|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
142632|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
142633|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
142634|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
142635|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
142636|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
142637|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
142638|NCT01777620|E2|Reported Event|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
142639|NCT01777620|E1|Reported Event|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
142640|NCT01777581|B3|Baseline|Total|Total of all reporting groups
142641|NCT01777581|B2|Baseline|Sugar Pill (Placebo)|Placebo
142642|NCT01777581|B1|Baseline|Milnacipran|Milnacipran, flexibly dosed 100-200 mg/day dosed twice a day
142643|NCT01777581|P2|Participant Flow|Sugar Pill (Placebo)|Placebo
142644|NCT01777581|P1|Participant Flow|Milnacipran|Milnacipran, flexibly dosed
142645|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
142646|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
142647|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
142648|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
142649|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
142650|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
142651|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
142652|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
142653|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
142654|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
142655|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
142656|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
142657|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
142658|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
142659|NCT01777581|E2|Reported Event|Sugar Pill (Placebo)|Placebo
142660|NCT01777581|E1|Reported Event|Milnacipran|Milnacipran, flexibly dosed
142661|NCT01777542|B1|Baseline|All Participants|All 30 subjects enrolled and randomized in the study
142662|NCT01777542|P2|Participant Flow|rhIGF-1 First, Then Placebo|One half of subjects will be randomly assigned to receive Recombinant Human Insulin Growth Factor 1 (rhIGF-1) during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of IGF-1.
142663|NCT01777542|P1|Participant Flow|Placebo First, Then rhIGF-1|One half of subjects will be randomly assigned to receive placebo during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of a saline solution (placebo).
142664|NCT01777542|O2|Outcome|rhIGF-1 First, Then Placebo|One half of subjects will be randomly assigned to receive Recombinant Human Insulin Growth Factor 1 (rhIGF-1) during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of IGF-1.
142665|NCT01777542|O1|Outcome|Placebo First, Then rhIGF-1|One half of subjects will be randomly assigned to receive placebo during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of a saline solution (placebo).
142666|NCT01777542|O2|Outcome|rhIGF-1 First, Then Placebo|One half of subjects will be randomly assigned to receive Recombinant Human Insulin Growth Factor 1 (rhIGF-1) during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of IGF-1.
142667|NCT01777542|O1|Outcome|Placebo First, Then rhIGF-1|One half of subjects will be randomly assigned to receive placebo during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of a saline solution (placebo).
142668|NCT01777542|O2|Outcome|rhIGF-1 First, Then Placebo|One half of subjects will be randomly assigned to receive Recombinant Human Insulin Growth Factor 1 (rhIGF-1) during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of IGF-1.
142669|NCT01777542|O1|Outcome|Placebo First, Then rhIGF-1|One half of subjects will be randomly assigned to receive placebo during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of a saline solution (placebo).
142670|NCT01777542|O2|Outcome|rhIGF-1 First, Then Placebo|One half of subjects will be randomly assigned to receive Recombinant Human Insulin Growth Factor 1 (rhIGF-1) during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of IGF-1.
142671|NCT01777542|O1|Outcome|Placebo First, Then rhIGF-1|One half of subjects will be randomly assigned to receive placebo during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of a saline solution (placebo).
142672|NCT01777542|O2|Outcome|rhIGF-1 First, Then Placebo|One half of subjects will be randomly assigned to receive Recombinant Human Insulin Growth Factor 1 (rhIGF-1) during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of IGF-1.
142673|NCT01777542|O1|Outcome|Placebo First, Then rhIGF-1|One half of subjects will be randomly assigned to receive placebo during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of a saline solution (placebo).
142674|NCT01777542|O2|Outcome|rhIGF-1 First, Then Placebo|One half of subjects will be randomly assigned to receive Recombinant Human Insulin Growth Factor 1 (rhIGF-1) during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of IGF-1.
142675|NCT01777542|O1|Outcome|Placebo First, Then rhIGF-1|One half of subjects will be randomly assigned to receive placebo during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of a saline solution (placebo).
142676|NCT01777542|O2|Outcome|rhIGF-1 First, Then Placebo|One half of subjects will be randomly assigned to receive Recombinant Human Insulin Growth Factor 1 (rhIGF-1) during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of IGF-1.
142677|NCT01777542|O1|Outcome|Placebo First, Then rhIGF-1|One half of subjects will be randomly assigned to receive placebo during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of a saline solution (placebo).
142678|NCT01777542|O2|Outcome|rhIGF-1 First, Then Placebo|One half of subjects will be randomly assigned to receive Recombinant Human Insulin Growth Factor 1 (rhIGF-1) during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of IGF-1.
142679|NCT01777542|O1|Outcome|Placebo First, Then rhIGF-1|One half of subjects will be randomly assigned to receive placebo during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of a saline solution (placebo).
142680|NCT01777542|O2|Outcome|rhIGF-1 First, Then Placebo|One half of subjects will be randomly assigned to receive Recombinant Human Insulin Growth Factor 1 (rhIGF-1) during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of IGF-1.
142681|NCT01777542|O1|Outcome|Placebo First, Then rhIGF-1|One half of subjects will be randomly assigned to receive placebo during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of a saline solution (placebo).
142682|NCT01777542|O2|Outcome|rhIGF-1 First, Then Placebo|One half of subjects will be randomly assigned to receive Recombinant Human Insulin Growth Factor 1 (rhIGF-1) during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of IGF-1.
142683|NCT01777542|O1|Outcome|Placebo First, Then rhIGF-1|One half of subjects will be randomly assigned to receive placebo during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of a saline solution (placebo).
142684|NCT01777542|O2|Outcome|rhIGF-1 First, Then Placebo|One half of subjects will be randomly assigned to receive Recombinant Human Insulin Growth Factor 1 (rhIGF-1) during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of IGF-1.
142685|NCT01777542|O1|Outcome|Placebo First, Then rhIGF-1|One half of subjects will be randomly assigned to receive placebo during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of a saline solution (placebo).
142686|NCT01777542|O2|Outcome|rhIGF-1 First, Then Placebo|One half of subjects will be randomly assigned to receive Recombinant Human Insulin Growth Factor 1 (rhIGF-1) during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of IGF-1.
142719|NCT01777425|O1|Outcome|Rhinosinusitis Patients|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
142687|NCT01777542|O1|Outcome|Placebo First, Then rhIGF-1|One half of subjects will be randomly assigned to receive placebo during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of a saline solution (placebo).
142688|NCT01777542|O2|Outcome|rhIGF-1 First, Then Placebo|One half of subjects will be randomly assigned to receive Recombinant Human Insulin Growth Factor 1 (rhIGF-1) during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of IGF-1.
142689|NCT01777542|O1|Outcome|Placebo First, Then rhIGF-1|One half of subjects will be randomly assigned to receive placebo during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of a saline solution (placebo).
142690|NCT01777542|O2|Outcome|rhIGF-1 First, Then Placebo|One half of subjects will be randomly assigned to receive Recombinant Human Insulin Growth Factor 1 (rhIGF-1) during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of IGF-1.
142691|NCT01777542|O1|Outcome|Placebo First, Then rhIGF-1|One half of subjects will be randomly assigned to receive placebo during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of a saline solution (placebo).
142692|NCT01777542|O2|Outcome|rhIGF-1 First, Then Placebo|One half of subjects will be randomly assigned to receive Recombinant Human Insulin Growth Factor 1 (rhIGF-1) during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of IGF-1.
142693|NCT01777542|O1|Outcome|Placebo First, Then rhIGF-1|One half of subjects will be randomly assigned to receive placebo during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of a saline solution (placebo).
142694|NCT01777542|O2|Outcome|rhIGF-1 First, Then Placebo|One half of subjects will be randomly assigned to receive Recombinant Human Insulin Growth Factor 1 (rhIGF-1) during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of IGF-1.
142695|NCT01777542|O1|Outcome|Placebo First, Then rhIGF-1|One half of subjects will be randomly assigned to receive placebo during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of a saline solution (placebo).
142696|NCT01777542|O2|Outcome|rhIGF-1 First, Then Placebo|One half of subjects will be randomly assigned to receive Recombinant Human Insulin Growth Factor 1 (rhIGF-1) during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of IGF-1.
142697|NCT01777542|O1|Outcome|Placebo First, Then rhIGF-1|One half of subjects will be randomly assigned to receive placebo during the first arm of the study. Subjects assigned to this group will receive twice daily subcutaneous injections of a saline solution (placebo).
142698|NCT01777542|E3|Reported Event|Off Treatment|This group includes subjects who had a reported Adverse Event (AE) while they were not receiving any treatment. This includes the period between Screening and Baseline, the 20-week washout period between study arms, and the 12-week follow up period after study completion.
142699|NCT01777542|E2|Reported Event|rhIGF-1|This group includes subjects who had a reported Adverse Event (AE) while they were receiving rhIGF-1 treatment.
142700|NCT01777542|E1|Reported Event|Placebo|This group includes subjects who had a reported Adverse Event (AE) while they were receiving placebo treatment.
142701|NCT01777438|B3|Baseline|Total|Total of all reporting groups
142702|NCT01777438|B2|Baseline|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
142703|NCT01777438|B1|Baseline|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
142704|NCT01777438|P2|Participant Flow|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
142705|NCT01777438|P1|Participant Flow|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
142706|NCT01777438|O2|Outcome|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
142707|NCT01777438|O1|Outcome|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
142708|NCT01777438|O2|Outcome|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
142709|NCT01777438|O1|Outcome|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
142710|NCT01777438|O2|Outcome|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
142711|NCT01777438|O1|Outcome|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
142712|NCT01777438|O2|Outcome|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
142713|NCT01777438|O1|Outcome|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
142714|NCT01777438|E2|Reported Event|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
142715|NCT01777438|E1|Reported Event|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
142716|NCT01777425|B1|Baseline|Rhinosinusitis Patients|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
142717|NCT01777425|P1|Participant Flow|Rhinosinusitis Patients|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
142718|NCT01777425|O1|Outcome|Rhinosinusitis Patients|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
142759|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
142720|NCT01777425|O1|Outcome|Rhinosinusitis Patients and Status|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
142721|NCT01777425|E1|Reported Event|Rhinosinusitis Patients|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
142722|NCT01777412|B1|Baseline|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
142723|NCT01777412|P1|Participant Flow|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
142724|NCT01777412|O1|Outcome|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
142725|NCT01777412|O1|Outcome|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
142726|NCT01777412|O1|Outcome|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
142727|NCT01777412|E1|Reported Event|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
142728|NCT01777334|B3|Baseline|Total|Total of all reporting groups
142729|NCT01777334|B2|Baseline|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD each morning via a DPI and placebo QD each morning via a DPI for 24 weeks.
142730|NCT01777334|B1|Baseline|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once daily (QD) each morning via a dry powder inhaler (DPI) and placebo QD each morning via a DPI for 24 weeks.
142731|NCT01777334|P2|Participant Flow|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD each morning via a DPI and placebo QD each morning via a DPI for 24 weeks.
142732|NCT01777334|P1|Participant Flow|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once daily (QD) each morning via a dry powder inhaler (DPI) and placebo QD each morning via a DPI for 24 weeks.
142733|NCT01777334|O2|Outcome|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD each morning via a DPI and placebo QD each morning via a DPI for 24 weeks.
142734|NCT01777334|O1|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once daily (QD) each morning via a dry powder inhaler (DPI) and placebo QD each morning via a DPI for 24 weeks.
142735|NCT01777334|O2|Outcome|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD each morning via a DPI and placebo QD each morning via a DPI for 24 weeks.
142736|NCT01777334|O1|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once daily (QD) each morning via a dry powder inhaler (DPI) and placebo QD each morning via a DPI for 24 weeks.
142737|NCT01777334|E2|Reported Event|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD each morning via a DPI and placebo QD each morning via a DPI for 24 weeks.
142738|NCT01777334|E1|Reported Event|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once daily (QD) each morning via a dry powder inhaler (DPI) and placebo QD each morning via a DPI for 24 weeks.
142739|NCT01777321|B3|Baseline|Total|Total of all reporting groups
142740|NCT01777321|B2|Baseline|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
142741|NCT01777321|B1|Baseline|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
142742|NCT01777321|P2|Participant Flow|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered intramuscularly (IM) on a 0,2-month schedule.
142743|NCT01777321|P1|Participant Flow|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered subcutaneously (SC) on a 0,2-month schedule.
142744|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
142745|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
142746|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
142747|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
142748|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
142749|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
142750|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
142751|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
142752|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
142753|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
142754|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
142755|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
142756|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
142757|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
142758|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
142763|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
142764|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
142765|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
142766|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
142767|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
142768|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
142769|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
142770|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
142771|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
142772|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
142773|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
142774|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
142775|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
142776|NCT01777321|E2|Reported Event|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
142777|NCT01777321|E1|Reported Event|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
142778|NCT01777282|B6|Baseline|Total|Total of all reporting groups
142779|NCT01777282|B5|Baseline|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142780|NCT01777282|B4|Baseline|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142781|NCT01777282|B3|Baseline|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142782|NCT01777282|B2|Baseline|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142783|NCT01777282|B1|Baseline|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142784|NCT01777282|P5|Participant Flow|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142785|NCT01777282|P4|Participant Flow|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142786|NCT01777282|P3|Participant Flow|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142787|NCT01777282|P2|Participant Flow|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142788|NCT01777282|P1|Participant Flow|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142789|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142790|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142791|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142792|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142793|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142794|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142861|NCT01777217|P2|Participant Flow|Placebo|"Drug: Placebo oral~Placebo"
142862|NCT01777217|P1|Participant Flow|Solifenacin Succinate|"Solifenacin succinate, 5mg or 10 mg once daily~Solifenacin succinate"
142795|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142796|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142797|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142798|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142799|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142800|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142801|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142802|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142803|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142804|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142805|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142806|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142807|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142808|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142809|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142810|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142811|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142812|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142813|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142814|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142815|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142816|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142817|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142818|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142819|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142820|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142821|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142822|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142823|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142824|NCT01777282|E5|Reported Event|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142825|NCT01777282|E4|Reported Event|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142826|NCT01777282|E3|Reported Event|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142827|NCT01777282|E2|Reported Event|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142828|NCT01777282|E1|Reported Event|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
142829|NCT01777269|B3|Baseline|Total|Total of all reporting groups
142830|NCT01777269|B2|Baseline|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
142831|NCT01777269|B1|Baseline|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
142832|NCT01777269|P2|Participant Flow|Duodart|Participants received a combination of dutasteride 0.5 milligrams (mg) and tamsulosin 0.4 mg plus lifestyle advice for 12 months
142833|NCT01777269|P1|Participant Flow|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
142834|NCT01777269|O2|Outcome|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
142835|NCT01777269|O1|Outcome|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
142836|NCT01777269|O2|Outcome|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
142837|NCT01777269|O1|Outcome|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
142838|NCT01777269|O2|Outcome|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
142839|NCT01777269|O1|Outcome|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
142840|NCT01777269|O2|Outcome|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
142841|NCT01777269|O1|Outcome|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
142842|NCT01777269|O2|Outcome|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
142843|NCT01777269|O1|Outcome|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
142844|NCT01777269|O2|Outcome|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
142845|NCT01777269|O1|Outcome|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
142846|NCT01777269|O2|Outcome|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
142847|NCT01777269|O1|Outcome|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
142848|NCT01777269|O2|Outcome|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
142849|NCT01777269|O1|Outcome|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
142850|NCT01777269|O2|Outcome|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
142851|NCT01777269|O1|Outcome|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
142852|NCT01777269|O2|Outcome|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
142853|NCT01777269|O1|Outcome|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
142854|NCT01777269|O2|Outcome|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
142855|NCT01777269|O1|Outcome|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
142856|NCT01777269|E2|Reported Event|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
142857|NCT01777269|E1|Reported Event|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
142858|NCT01777217|B3|Baseline|Total|Total of all reporting groups
142859|NCT01777217|B2|Baseline|Placebo|"Drug: Placebo oral~Placebo"
142860|NCT01777217|B1|Baseline|Solifenacin Succinate|"Solifenacin succinate, 5mg or 10 mg once daily~Solifenacin succinate"
142864|NCT01777217|O1|Outcome|Solifenacin Succinate|"Solifenacin succinate, 5mg or 10 mg once daily~Solifenacin succinate"
142865|NCT01777217|E2|Reported Event|Placebo|"Drug: Placebo oral~Placebo"
142866|NCT01777217|E1|Reported Event|Solifenacin Succinate|"Solifenacin succinate, 5mg or 10 mg once daily~Solifenacin succinate"
142867|NCT01777191|B3|Baseline|Total|Total of all reporting groups
142868|NCT01777191|B2|Baseline|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
142869|NCT01777191|B1|Baseline|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
142870|NCT01777191|P2|Participant Flow|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
142871|NCT01777191|P1|Participant Flow|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 milligrams (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection every two weeks (Q2W) at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose every 4 weeks (Q4W).
142872|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
142873|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
142874|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
142875|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
142876|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
142877|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
142878|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
142879|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
142880|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
142881|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
142882|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
142883|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
142884|NCT01777191|O1|Outcome|80 mg Ixekizumab|Ixekizumab administered via prefilled syringe and auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
142885|NCT01777191|O1|Outcome|80 mg Ixekizumab|Ixekizumab administered via prefilled syringe and auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
142886|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
142887|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
147505|NCT01761565|O1|Outcome|Single Dose of SUF NT 15 mcg|Arm 1/Period 1: Single dose of SUF NT 15 mcg
142888|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
142889|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
142890|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
142891|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
142892|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
142893|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
142894|NCT01777191|E4|Reported Event|Follow Up Period|All participants who received at least 1 dose of Ixekizumab entered the follow-up period.
142895|NCT01777191|E3|Reported Event|80 mg Ixe Prefilled Syringe Optional Safety Extension|One 80 mg Ixekizumab administered as an SC injection Q4W.
142896|NCT01777191|E2|Reported Event|80 mg Ixekizumab Auto-Injector Treatment Period|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
142897|NCT01777191|E1|Reported Event|80 mg Ixekizumab Prefilled Syringe Treatment Period|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
142898|NCT01777126|B3|Baseline|Total|Total of all reporting groups
142899|NCT01777126|B2|Baseline|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
142900|NCT01777126|B1|Baseline|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
142901|NCT01777126|P2|Participant Flow|Oral Nutrition Protocol (ONP) Group|In this group, oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
142902|NCT01777126|P1|Participant Flow|Control Group|In the control group, PN was part of the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
142919|NCT01777126|O1|Outcome|Control Group|For subjects enrolled in this arm, PN was part of the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
142903|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
142904|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
142905|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
142906|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
142907|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
142908|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
142909|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
142910|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
142956|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142957|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142911|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
142912|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
142913|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
142914|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
142915|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
142916|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
142917|NCT01777126|O1|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
142918|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
142958|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
147506|NCT01761565|O1|Outcome|40 Consecutive Doses of SUF NT 15 mcg|
142920|NCT01777126|E2|Reported Event|Enhanced Recovery Oral Nutrition Protocol (ERONP) Group|Subjects enrolled in this arm will undergo the ERONP protocol. An enhanced oral nutrition protocol (ERONP) with restrictive instructions for parenteral nutrition is implemented. Oral intake is increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used are Fortimel Juicy® (Nutricia) 200 ml containing 300 kcal. This provides supplementary energy and essential nutrients. Supplementary fluid, approximately up to two liter, is given intravenously. If the patient is unable to produce stools on the third day post-surgery, neostigmine (Prostigmin® 0.5 mg subcutaneous, maximum 4 times a day), an acetylcholinesterase inhibitor promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel, can be administered. Only if oral intake is still insufficient after five days, PN (Oliclinomel N7) can be initiated.
142921|NCT01777126|E1|Reported Event|Control Group|Subjects enrolled in this arm will undergo usual medical and pharmaceutical care. In this group, parenteral nutrition (Oliclinomel N7) is part of the routine postoperative care program.
142922|NCT01776645|B3|Baseline|Total|Total of all reporting groups
142923|NCT01776645|B2|Baseline|Significant Others Group|Significant Others of Participants with Chronic Pain
142924|NCT01776645|B1|Baseline|Compassion Cultivation Training - Participants With Chronic Pa|Compassion Cultivation Training Course - Participants with Chronic Pain
142925|NCT01776645|P2|Participant Flow|Significant Others Group|Significant others of the individuals with chronic pain undergoing the compassion cultivation training course
142926|NCT01776645|P1|Participant Flow|Compassion Cultivation Training|Compassion Cultivation Training Course - Participants with Chronic Pain
142927|NCT01776645|O1|Outcome|Compassion Cultivation Training|Compassion Cultivation Training Course - Participants with Chronic Pain
142928|NCT01776645|O1|Outcome|Compassion Cultivation Training|Compassion Cultivation Training Course - Participants with Chronic Pain
142929|NCT01776645|E2|Reported Event|Significant Others Group|Significant others of the individuals with chronic pain undergoing the compassion cultivation training course
142930|NCT01776645|E1|Reported Event|Compassion Cultivation Training|Compassion Cultivation Training Course - Participants with Chronic Pain
142931|NCT01776554|B3|Baseline|Total|Total of all reporting groups
142932|NCT01776554|B2|Baseline|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142933|NCT01776554|B1|Baseline|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142934|NCT01776554|P2|Participant Flow|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142935|NCT01776554|P1|Participant Flow|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142936|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142937|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142938|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142939|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142940|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142941|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142942|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142943|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142944|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142945|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142946|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142947|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142948|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142949|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142950|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142951|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142952|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142953|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142954|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142955|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142959|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142960|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142961|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142962|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142963|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142964|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142965|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142966|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142967|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142968|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142969|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142970|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142971|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142972|NCT01776554|E3|Reported Event|Total|Total of subjects in both high dose and low dose groups.
142973|NCT01776554|E2|Reported Event|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142974|NCT01776554|E1|Reported Event|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142975|NCT01776541|B3|Baseline|Total|Total of all reporting groups
142976|NCT01776541|B2|Baseline|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
142977|NCT01776541|B1|Baseline|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
142978|NCT01776541|P2|Participant Flow|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142979|NCT01776541|P1|Participant Flow|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142980|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
142981|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
142982|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
142983|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
142984|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
142985|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
142986|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
142987|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
142988|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
142989|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
142990|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
142991|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
142992|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
142993|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
142994|NCT01776541|E3|Reported Event|Total|Total of high dose and low dose groups.
142995|NCT01776541|E2|Reported Event|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142996|NCT01776541|E1|Reported Event|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
142997|NCT01776268|B3|Baseline|Total|Total of all reporting groups
142998|NCT01776268|B2|Baseline|no Oral Priming|No oral priming: no intervention
142999|NCT01776268|B1|Baseline|Oral Priming|Intervention:Mother's own colostrum is administered (0.1 mL to each cheek every 6 hours for 5 days) as soon as it is available from the mother regardless of when enteral feedings are initiated.
143001|NCT01776268|P1|Participant Flow|Colostrum Priming|Intervention:Mother's own colostrum is administered (0.1 mL to each cheek every 6 hours for 5 days) as soon as it is available from the mother regardless of when enteral feedings are initiated.
143002|NCT01776268|O2|Outcome|No Oral Priming|No oral priming
143003|NCT01776268|O1|Outcome|Oral Priming|Intervention:Mother's own colostrum is administered (0.1 mL to each cheek every 6 hours for 5 days) as soon as it is available from the mother regardless of when enteral feedings are initiated.
143004|NCT01776268|O2|Outcome|No Oral Priming|
143005|NCT01776268|O1|Outcome|Oral Priming|Intervention:Mother's own colostrum is administered (0.1 mL to each cheek every 6 hours for 5 days) as soon as it is available from the mother regardless of when enteral feedings are initiated.
143006|NCT01776268|E2|Reported Event|no Oral Priming|No oral priming: no intervention
143007|NCT01776268|E1|Reported Event|Oral Priming|Intervention:Mother's own colostrum is administered (0.1 mL to each cheek every 6 hours for 5 days) as soon as it is available from the mother regardless of when enteral feedings are initiated.
143008|NCT01776008|B1|Baseline|Treatment (MK2206, Anastrozole, Goserelin Acetate)|Patients receive 150 mg Akt inhibitor MK-2206 PO on days 2, 9, 16, and 23; 1 mg anastrozole PO daily on days 1-28; and 3.6 mg goserelin acetate SC on day 1 (premenopausal patients only). Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
143009|NCT01776008|P1|Participant Flow|Treatment (MK2206, Anastrozole, Goserelin Acetate)|Patients receive 150 mg Akt inhibitor MK-2206 PO on days 2, 9, 16, and 23; 1 mg anastrozole PO daily on days 1-28; and 3.6 mg goserelin acetate SC on day 1 (premenopausal patients only). Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
143010|NCT01776008|O1|Outcome|Treatment (MK2206, Anastrozole, Goserelin Acetate)|Patients receive 150 mg Akt inhibitor MK-2206 PO on days 2, 9, 16, and 23; 1 mg anastrozole PO daily on days 1-28; and 3.6 mg goserelin acetate SC on day 1 (premenopausal patients only). Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
143011|NCT01776008|O1|Outcome|Treatment (MK2206, Anastrozole, Goserelin Acetate)|Patients receive 150 mg Akt inhibitor MK-2206 PO on days 2, 9, 16, and 23; 1 mg anastrozole PO daily on days 1-28; and 3.6 mg goserelin acetate SC on day 1 (premenopausal patients only). Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
143012|NCT01776008|O1|Outcome|Treatment (MK2206, Anastrozole, Goserelin Acetate)|Patients receive 150 mg Akt inhibitor MK-2206 PO on days 2, 9, 16, and 23; 1 mg anastrozole PO daily on days 1-28; and 3.6 mg goserelin acetate SC on day 1 (premenopausal patients only). Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
143013|NCT01776008|O1|Outcome|Treatment (MK2206, Anastrozole, Goserelin Acetate)|Patients receive 150 mg Akt inhibitor MK-2206 PO on days 2, 9, 16, and 23; 1 mg anastrozole PO daily on days 1-28; and 3.6 mg goserelin acetate SC on day 1 (premenopausal patients only). Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
143014|NCT01776008|O1|Outcome|Treatment (MK2206, Anastrozole, Goserelin Acetate)|Patients receive 150 mg Akt inhibitor MK-2206 PO on days 2, 9, 16, and 23; 1 mg anastrozole PO daily on days 1-28; and 3.6 mg goserelin acetate SC on day 1 (premenopausal patients only). Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
143015|NCT01776008|O1|Outcome|Treatment (MK2206, Anastrozole, Goserelin Acetate)|Patients receive 150 mg Akt inhibitor MK-2206 PO on days 2, 9, 16, and 23; 1 mg anastrozole PO daily on days 1-28; and 3.6 mg goserelin acetate SC on day 1 (premenopausal patients only). Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
143016|NCT01776008|O1|Outcome|Treatment (MK2206, Anastrozole, Goserelin Acetate)|Patients receive 150 mg Akt inhibitor MK-2206 PO on days 2, 9, 16, and 23; 1 mg anastrozole PO daily on days 1-28; and 3.6 mg goserelin acetate SC on day 1 (premenopausal patients only). Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
143017|NCT01776008|O1|Outcome|Treatment (MK2206, Anastrozole, Goserelin Acetate)|Patients receive 150 mg Akt inhibitor MK-2206 PO on days 2, 9, 16, and 23; 1 mg anastrozole PO daily on days 1-28; and 3.6 mg goserelin acetate SC on day 1 (premenopausal patients only). Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
143018|NCT01776008|O1|Outcome|Treatment (MK2206, Anastrozole, Goserelin Acetate)|Patients receive 150 mg Akt inhibitor MK-2206 PO on days 2, 9, 16, and 23; 1 mg anastrozole PO daily on days 1-28; and 3.6 mg goserelin acetate SC on day 1 (premenopausal patients only). Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
143019|NCT01776008|E1|Reported Event|Treatment (MK2206, Anastrozole, Goserelin Acetate)|Patients receive 150 mg Akt inhibitor MK-2206 PO on days 2, 9, 16, and 23; 1 mg anastrozole PO daily on days 1-28; and 3.6 mg goserelin acetate SC on day 1 (premenopausal patients only). Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
143020|NCT01775995|B3|Baseline|Total|Total of all reporting groups
143021|NCT01775995|B2|Baseline|Wait-list Control|Standard of Care Therapy only
143022|NCT01775995|B1|Baseline|Experimental: Meditation-CBT|"Mindfulness-CBT + Standard of Care Therapy~Mindfulness Based Intervention with Cognitive Behavioral Therapy (CBT) components: All study subjects receive standard of care therapy. In addition, experimental subjects receive the mindfulness-CBT. The intervention consists of an 8-week meditation-CBT course (2 hour weekly group sessions) and daily, at-home practice (30 mins/day, 6 days/week of formal practice). Controls will be offered meditation intervention after completing the study."
143023|NCT01775995|P2|Participant Flow|Wait-list Control|"Usual Care~Participants receiving usual care for CLBP and opioid therapy management."
143024|NCT01775995|P1|Participant Flow|Meditation-CBT|"Meditation-CBT + Usual Care~Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management."
143025|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143026|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143027|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143028|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143029|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143030|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143031|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143032|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143033|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143034|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143035|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143036|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143037|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143038|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143039|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143040|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143041|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143042|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143043|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143044|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143045|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143046|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143047|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143048|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143049|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143050|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143051|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143052|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143053|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143054|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143055|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143056|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143057|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143058|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143059|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143060|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143061|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143062|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143063|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143064|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143065|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143066|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143067|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143068|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
147507|NCT01761565|O2|Outcome|40 Consecutive Doses of SUF NT 15 mcg|
143069|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143070|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143071|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143072|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143073|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143074|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143075|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143076|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143077|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143078|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143079|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
143080|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
143081|NCT01775995|E2|Reported Event|Wait-list Control|Standard of Care Therapy only
143082|NCT01775995|E1|Reported Event|Experimental: Meditation-CBT|"Mindfulness-CBT + Standard of Care Therapy~Mindfulness Based Intervention with Cognitive Behavioral Therapy (CBT) components: All study subjects receive standard of care therapy. In addition, experimental subjects receive the mindfulness-CBT. The intervention consists of an 8-week meditation-CBT course (2 hour weekly group sessions) and daily, at-home practice (30 mins/day, 6 days/week of formal practice). Controls will be offered meditation intervention after completing the study."
143083|NCT01775865|B4|Baseline|Total|Total of all reporting groups
143084|NCT01775865|B3|Baseline|Young Control|No intervention, not randomized; Baseline measurements only
143085|NCT01775865|B2|Baseline|Placebo|Placebo capsule twice per day by mouth for 4 weeks
143086|NCT01775865|B1|Baseline|Salsalate|Salsalate capusule 1.5 g twice per day by mouth for 4 weeks
143087|NCT01775865|P3|Participant Flow|Young Control|No intervention; Baseline measurements only, participants not randomized
143088|NCT01775865|P2|Participant Flow|Placebo|"Placebo capsule twice per day by mouth for 4 weeks~Placebo (for salsalate)"
143089|NCT01775865|P1|Participant Flow|Salsalate|"Salsalate capsule 1.5 g twice per day by mouth for 4 weeks~Salsalate"
143090|NCT01775865|O3|Outcome|Young Control Group|No intervention; Baseline measurements only, participants not randomized
143091|NCT01775865|O2|Outcome|Placebo|Placebo capsules twice per day by mouth for 4 weeks
143092|NCT01775865|O1|Outcome|Salsalate|Salsalate capsule 1.5 g twice per day by mouth for 4 weeks
143093|NCT01775865|O3|Outcome|Young Control Group|No intervention; Baseline measurements only; participants not randomized
143094|NCT01775865|O2|Outcome|Placebo|Placebo capsule twice per day by mouth for 4 weeks
143095|NCT01775865|O1|Outcome|Salsalate|Salsalate capsule 1.5 g twice per day by mouth for 4 weeks
143096|NCT01775865|O3|Outcome|Young Control Group|No Intervention; Baseline measurements only, participants not randomized
143097|NCT01775865|O2|Outcome|Placebo|Received 4 weeks of placebo
143098|NCT01775865|O1|Outcome|Salsalate|Received 4 weeks of daily oral salsalate
143099|NCT01775865|E3|Reported Event|Young Control Group|No intervention; Baseline measurements only; Participants not randomized
143100|NCT01775865|E2|Reported Event|Placebo|Placebo capusule twice per day by mouth for 4 weeks
143101|NCT01775865|E1|Reported Event|Salsalate|Salsalate 1.5 g twice per day by mouth for 4 weeks
143102|NCT01775852|B3|Baseline|Total|Total of all reporting groups
143103|NCT01775852|B2|Baseline|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
143104|NCT01775852|B1|Baseline|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.~ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
143105|NCT01775852|P2|Participant Flow|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
143106|NCT01775852|P1|Participant Flow|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.~ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
143189|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
143107|NCT01775852|O2|Outcome|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
143108|NCT01775852|O1|Outcome|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.~ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
143109|NCT01775852|O2|Outcome|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
143110|NCT01775852|O1|Outcome|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.~ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
143111|NCT01775852|O2|Outcome|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
143112|NCT01775852|O1|Outcome|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.~ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
143113|NCT01775852|O2|Outcome|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
143114|NCT01775852|O1|Outcome|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.~ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
143115|NCT01775852|E2|Reported Event|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
143116|NCT01775852|E1|Reported Event|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.~ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
143117|NCT01775787|B1|Baseline|Nicotine With Tobacco Flavor and With Tobacco & Menthol Flavor|Smokers were assigned to electronic cigarettes containing 18mg/mL of nicotine in either a tobacco flavor solution or a tobacco and menthol flavor solution and then switched to other flavor for an additional 7 to 10 days. Monitoring sessions occurred on the last day of trial period of each flavor.
143118|NCT01775787|P2|Participant Flow|Tobacco & Menthol Flavor/Tobacco Flavor|"Subjects randomized to Tobacco and Menthol Flavor for 7-10 days,then crossed over to Tobacco Flavor for 7-10 days.~Nicotine with Tobacco Flavor or Tobacco & Menthol Flavor (18mg/mL nicotine)"
143119|NCT01775787|P1|Participant Flow|Tobacco Flavor/ Tobacco & Menthol Flavor|"Subjects randomized to Tobacco Flavor group 7-10 days, then crossed over to Tobacco and Menthol Flavor for 7-10 days.~Nicotine with Tobacco Flavor or Tobacco & Menthol Flavor (18mg/mL nicotine"
143120|NCT01775787|O2|Outcome|Tobacco & Menthol Flavor|Subjects received tobacco & menthol flavored nicotine for 7-10 days
143121|NCT01775787|O1|Outcome|Tobacco Flavor|Subjects received tobacco flavored nicotine for 7-10 days
143122|NCT01775787|E4|Reported Event|Tobacco & Menthol Flavor & Tobacco Flavor (TOB Flavor)|"AE occurred in intervention Tobacco Flavor Session 2 7-10 days~Subjects randomized to Tobacco & Menthol Flavor group 7-10 days, then crossed over to Tobacco Flavor for 7-10 days.~Nicotine with Tobacco Flavor or Tobacco & Menthol Flavor (18mg/mL nicotine)"
143123|NCT01775787|E3|Reported Event|Tobacco & Menthol Flavor & Tobacco Flavor (TOB/MENTH Flavor)|"AE occurred in intervention Tobacco & Menthol Flavor Session 17-10 days~Subjects randomized to Tobacco & Menthol Flavor group 7-10 days, then crossed over to Tobacco Flavor for 7-10 days.~Nicotine with Tobacco Flavor or Tobacco & Menthol Flavor (18mg/mL nicotine)"
143235|NCT01775189|O2|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143124|NCT01775787|E2|Reported Event|Tobacco Flavor & Tobacco & Menthol Flavor (TOB/MENTH Flavor)|"AE occurred in intervention Tobacco Flavor Session 27-10 days~Subjects randomized to Tobacco Flavor group 7-10 days, then crossed over to Tobacco and Menthol Flavor for 7-10 days.~Nicotine with Tobacco Flavor or Tobacco & Menthol Flavor (18mg/mL nicotine)"
143125|NCT01775787|E1|Reported Event|Tobacco Flavor & Tobacco & Menthol Flavor (TOB Flavor)|"AE occurred in intervention Tobacco Flavor Session 17-10 days~Subjects randomized to Tobacco Flavor group 7-10 days, then crossed over to Tobacco and Menthol Flavor for 7-10 days.~Nicotine with Tobacco Flavor or Tobacco & Menthol Flavor (18mg/mL nicotine)"
143126|NCT01775774|B4|Baseline|Total|Total of all reporting groups
143127|NCT01775774|B3|Baseline|Mesenchymal Stem Cells 10 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143128|NCT01775774|B2|Baseline|Mesenchymal Stem Cells 5 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143129|NCT01775774|B1|Baseline|Human Mesenchymal Stem Cells 1 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143130|NCT01775774|P3|Participant Flow|Human Mesenchymal Stem Cells 10 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143131|NCT01775774|P2|Participant Flow|Human Mesenchymal Stem Cells 5 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143132|NCT01775774|P1|Participant Flow|Human Mesenchymal Stem Cells 1 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143133|NCT01775774|O3|Outcome|Human Mesenchymal Stem Cells: 10 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143134|NCT01775774|O2|Outcome|Human Mesenchymal Stem Cells: 5 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143135|NCT01775774|O1|Outcome|Human Mesenchymal Stem Cells: 1 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143136|NCT01775774|O3|Outcome|Human Mesenchymal Stem Cells: 10 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143137|NCT01775774|O2|Outcome|Human Mesenchymal Stem Cells: 5 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143138|NCT01775774|O1|Outcome|Human Mesenchymal Stem Cells: 1 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143139|NCT01775774|O3|Outcome|Human Mesenchymal Stem Cells: 10 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143140|NCT01775774|O2|Outcome|Human Mesenchymal Stem Cells: 5 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143141|NCT01775774|O1|Outcome|Human Mesenchymal Stem Cells: 1 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143142|NCT01775774|O3|Outcome|Human Mesenchymal Stem Cells: 10 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143143|NCT01775774|O2|Outcome|Human Mesenchymal Stem Cells: 5 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143144|NCT01775774|O1|Outcome|Human Mesenchymal Stem Cells: 1 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143145|NCT01775774|O3|Outcome|Human Mesenchymal Stem Cells: 10 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143146|NCT01775774|O2|Outcome|Human Mesenchymal Stem Cells: 5 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143147|NCT01775774|O1|Outcome|Human Mesenchymal Stem Cells: 1 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143148|NCT01775774|O3|Outcome|Human Mesenchymal Stem Cells: 10 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143149|NCT01775774|O2|Outcome|Human Mesenchymal Stem Cells: 5 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143150|NCT01775774|O1|Outcome|Human Mesenchymal Stem Cells: 1 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143151|NCT01775774|O3|Outcome|Human Mesenchymal Stem Cells: 10 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143152|NCT01775774|O2|Outcome|Human Mesenchymal Stem Cells: 5 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143153|NCT01775774|O1|Outcome|Human Mesenchymal Stem Cells: 1 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
143154|NCT01775774|E3|Reported Event|Human Mesenchymal Stem Cells: 10 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously.
143155|NCT01775774|E2|Reported Event|Human Mesenchymal Stem Cells: 5 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously.
143156|NCT01775774|E1|Reported Event|Human Mesenchymal Stem Cells: 1 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously.
143236|NCT01775189|O1|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143157|NCT01775722|B1|Baseline|Combined Radio Frequency and Pulsed Dye Laser Treatment|There are two test sites on each Port Wine Stain, one test site was treated with Pulsed dye laser only, and another test site was treated with combined radio frequency and pulsed dye laser. Two test sites were placed side by side randomly on each subject’s port wine stain area.
143158|NCT01775722|P1|Participant Flow|Combined Radio Frequency and Pulsed Dye Laser Treatment|This is a within-participant design due to the response of port wine stain to laser therapy varies greatly from patient to patient. Pulsed dye laser only test site and combined radio frequency and pulsed dye laser test site were placed side by side on each subject’s port wine stain area. Thus the differences among subjects will be explicitly accounted for and removed from the error component when assessing treatment effects.
143159|NCT01775722|O2|Outcome|Combined Radio Frequency and Pulsed Dye Laser Treatment|Measurement on test sites treated with combined Radio Frequency and Pulsed Dye Laser.
143160|NCT01775722|O1|Outcome|Pulsed Dye Laser Only Treatment|Measurement on the test site treated with Pulsed Dye Laser only.
143161|NCT01775722|E2|Reported Event|Combined Radio Frequency and Pulsed Dye Laser Treatment|Adverse event on test sites treated with combined Radio Frequency and Pulsed Dye Laser.
143162|NCT01775722|E1|Reported Event|Pulsed Dye Laser Only Treatment|Adverse event on the test site treated with Pulsed Dye Laser only.
143163|NCT01775670|B3|Baseline|Total|Total of all reporting groups
143164|NCT01775670|B2|Baseline|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
143165|NCT01775670|B1|Baseline|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
143166|NCT01775670|P2|Participant Flow|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the Massachusetts General Hospital (MGH) Occupational Therapists.~Occupational Therapy (OT) Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
143167|NCT01775670|P1|Participant Flow|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for trapeziometacarpal (TMC) arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
143168|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
143169|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
143170|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
143171|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
143172|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
143173|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
143174|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
143175|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
143176|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
143177|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
143178|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
143179|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
143180|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
143181|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
143182|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
143183|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
143184|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
143185|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
143186|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
143187|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
143188|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
143800|NCT01773291|O1|Outcome|Acupuncture|"acupuncture on GV26 and 12 Well points~acupuncture: acupuncture on GV26 and 12 Well points"
143190|NCT01775670|E2|Reported Event|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
143191|NCT01775670|E1|Reported Event|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
143192|NCT01775553|B1|Baseline|Carfilzomib|"All patients will receive Carfilzomib~Carfilzomib: During Cycle 1, patients will receive either 20 mg/m2 on days 1,2 (if the subject has not received carfilzomib as part another clinical trial within the last 4 weeks) or 56 mg/m2 (if the subject is enrolling in the present study after progression of disease on carfilzomib within the last month - for example subjects enrolled in CMAP compassionate use carfilzomib). Thereafter, all subjects will receive 56 mg/m2 for the remaining doses given Cycle 1 Day 8 onwards. Each cycle is 28 days."
143193|NCT01775553|P1|Participant Flow|Carfilzomib|"All patients will receive Carfilzomib~Carfilzomib: During Cycle 1, patients will receive either 20 mg/m2 on days 1,2 (if the subject has not received carfilzomib as part another clinical trial within the last 4 weeks) or 56 mg/m2 (if the subject is enrolling in the present study after progression of disease on carfilzomib within the last month - for example subjects enrolled in CMAP compassionate use carfilzomib). Thereafter, all subjects will receive 56 mg/m2 for the remaining doses given Cycle 1 Day 8 onwards. Each cycle is 28 days."
143194|NCT01775553|O1|Outcome|Carfilzomib|"All patients will receive Carfilzomib~Carfilzomib: During Cycle 1, patients will receive either 20 mg/m2 on days 1,2 (if the subject has not received carfilzomib as part another clinical trial within the last 4 weeks) or 56 mg/m2 (if the subject is enrolling in the present study after progression of disease on carfilzomib within the last month - for example subjects enrolled in CMAP compassionate use carfilzomib). Thereafter, all subjects will receive 56 mg/m2 for the remaining doses given Cycle 1 Day 8 onwards. Each cycle is 28 days."
143195|NCT01775553|O1|Outcome|Carfilzomib|"All patients will receive Carfilzomib~Carfilzomib: During Cycle 1, patients will receive either 20 mg/m2 on days 1,2 (if the subject has not received carfilzomib as part another clinical trial within the last 4 weeks) or 56 mg/m2 (if the subject is enrolling in the present study after progression of disease on carfilzomib within the last month - for example subjects enrolled in CMAP compassionate use carfilzomib). Thereafter, all subjects will receive 56 mg/m2 for the remaining doses given Cycle 1 Day 8 onwards. Each cycle is 28 days."
143196|NCT01775553|O1|Outcome|Carfilzomib|"All patients will receive Carfilzomib~Carfilzomib: During Cycle 1, patients will receive either 20 mg/m2 on days 1,2 (if the subject has not received carfilzomib as part another clinical trial within the last 4 weeks) or 56 mg/m2 (if the subject is enrolling in the present study after progression of disease on carfilzomib within the last month - for example subjects enrolled in CMAP compassionate use carfilzomib). Thereafter, all subjects will receive 56 mg/m2 for the remaining doses given Cycle 1 Day 8 onwards. Each cycle is 28 days."
143197|NCT01775553|O1|Outcome|Carfilzomib|"All patients will receive Carfilzomib~Carfilzomib: During Cycle 1, patients will receive either 20 mg/m2 on days 1,2 (if the subject has not received carfilzomib as part another clinical trial within the last 4 weeks) or 56 mg/m2 (if the subject is enrolling in the present study after progression of disease on carfilzomib within the last month - for example subjects enrolled in CMAP compassionate use carfilzomib). Thereafter, all subjects will receive 56 mg/m2 for the remaining doses given Cycle 1 Day 8 onwards. Each cycle is 28 days."
143198|NCT01775553|O1|Outcome|Carfilzomib|"All patients will receive Carfilzomib~Carfilzomib: During Cycle 1, patients will receive either 20 mg/m2 on days 1,2 (if the subject has not received carfilzomib as part another clinical trial within the last 4 weeks) or 56 mg/m2 (if the subject is enrolling in the present study after progression of disease on carfilzomib within the last month - for example subjects enrolled in CMAP compassionate use carfilzomib). Thereafter, all subjects will receive 56 mg/m2 for the remaining doses given Cycle 1 Day 8 onwards. Each cycle is 28 days."
143199|NCT01775553|E1|Reported Event|Carfilzomib|"All patients will receive Carfilzomib~Carfilzomib: During Cycle 1, patients will receive either 20 mg/m2 on days 1,2 (if the subject has not received carfilzomib as part another clinical trial within the last 4 weeks) or 56 mg/m2 (if the subject is enrolling in the present study after progression of disease on carfilzomib within the last month - for example subjects enrolled in CMAP compassionate use carfilzomib). Thereafter, all subjects will receive 56 mg/m2 for the remaining doses given Cycle 1 Day 8 onwards. Each cycle is 28 days."
143200|NCT01775189|B1|Baseline|Entire Study Population|Included all participants enrolled in the study.
143201|NCT01775189|P7|Participant Flow|PBO SS, ALO-02 30 mg, OXY 30 mg, PBO Lac|Single dose of placebo matched to ALO-02 (PBO SS) 30 mg/3.6 mg crushed capsule intranasally in first intervention period; followed by single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in second intervention period; then single dose of oxycodone HCl 30 mg (OXY 30 mg) crushed tablet intranasally in third intervention period; then single dose of placebo matched to oxycodone (PBO Lac) 30 mg crushed tablet intranasally in fourth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
143202|NCT01775189|P6|Participant Flow|OXY 30 mg, PBO SS, PBO Lac, ALO-02 30 mg|Single dose of oxycodone HCl 30 mg (OXY 30 mg) crushed tablet intranasally in first intervention period; followed by single dose of placebo matched to ALO-02 (PBO SS) 30 mg/3.6 mg crushed capsule intranasally in second intervention period; then single dose of placebo matched to oxycodone (PBO Lac) 30 mg crushed tablet intranasally in third intervention period; then single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in fourth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
143203|NCT01775189|P5|Participant Flow|ALO-02 30 mg, PBO Lac, PBO SS, OXY 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in first intervention period; followed by single dose of placebo matched to oxycodone (PBO Lac) 30 mg crushed tablet intranasally in second intervention period; then single dose of placebo matched to ALO-02 (PBO SS) 30 mg/3.6 mg crushed capsule intranasally in third intervention period; then single dose of oxycodone HCl 30 mg (OXY 30 mg) crushed tablet intranasally in fourth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
143237|NCT01775189|O2|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143238|NCT01775189|O1|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143239|NCT01775189|O2|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143204|NCT01775189|P4|Participant Flow|PBO Lac, OXY 30 mg, ALO-02 30 mg, PBO SS|Single dose of placebo matched to oxycodone (PBO Lac) 30 mg crushed tablet intranasally in first intervention period; followed by single dose of oxycodone HCl 30 mg (OXY 30 mg) crushed tablet intranasally in second intervention period; then single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in third intervention period; then single dose of placebo matched to ALO-02 (PBO SS) 30 mg/3.6 mg capsule intranasally in fourth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
143205|NCT01775189|P3|Participant Flow|Placebo Then Oxycodone HCl 30 mg|Single dose of placebo matched to oxycodone HCl 30 mg crushed tablet intranasally on Day 1 followed by single dose of oxycodone HCl 30 mg crushed tablet intranasally on Day 2. Participants were assigned to receive ALO-02 30 mg/3.6 mg crushed capsule, placebo matched to ALO-02 30 mg/3.6 mg crushed capsule (PBO SS), oxycodone 30 mg crushed tablet (OXY 30 mg), placebo matched to oxycodone 30 mg crushed tablet (PBO Lac), intranasally, in any of the 4 sequences in the treatment phase of the study.
143206|NCT01775189|P2|Participant Flow|Oxycodone HCl 30 mg Then Placebo|Single dose of oxycodone HCl 30 mg crushed tablet intranasally on Day 1 followed by single dose of placebo matched to oxycodone HCl 30 mg crushed tablet intranasally on Day 2. Participants were assigned to receive oxycodone HCl 30 mg and naltrexone HCl 3.6 mg extended-release (ALO-02) 30 mg/3.6 mg crushed capsule, placebo matched to ALO-02 30 mg/3.6 mg crushed capsule (placebo sugar spheres, PBO SS), oxycodone 30 mg crushed tablet (OXY 30 mg), placebo matched to oxycodone 30 mg crushed tablet (placebo lactose tablet, PBO Lac), intranasally, in any of the 4 sequences in the treatment phase of the study.
143207|NCT01775189|P1|Participant Flow|Naloxone|Naloxone hydrochloride (HCl) 0.2 milligram (mg) intravenously followed by additional 0.6 mg naloxone hydrochloride intravenously on Day 0, each dose followed by an assessment for signs and symptoms of opioid withdrawal. Participants who did not display signs and symptoms of opioid withdrawal, were assigned to either oxycodone HCl 30 mg then placebo or placebo then oxycodone HCl 30 mg group in the drug discrimination phase of the study.
143208|NCT01775189|O6|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143209|NCT01775189|O5|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143210|NCT01775189|O4|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143211|NCT01775189|O3|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143212|NCT01775189|O2|Outcome|Placebo Oxycodone HCl|Single dose of placebo matched to oxycodone HCl 30 mg crushed tablet intranasally on either of 2 days in drug discrimination phase.
143213|NCT01775189|O1|Outcome|Oxycodone HCl 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally on either of 2 days in drug discrimination phase.
143214|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143215|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143216|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143217|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143218|NCT01775189|O7|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143219|NCT01775189|O6|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143220|NCT01775189|O5|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143221|NCT01775189|O4|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143222|NCT01775189|O3|Outcome|Placebo Oxycodone HCl|Single dose of placebo matched to oxycodone HCl 30 mg crushed tablet intranasally on either of 2 days in drug discrimination phase.
143223|NCT01775189|O2|Outcome|Oxycodone HCl 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally on either of 2 days in drug discrimination phase.
143224|NCT01775189|O1|Outcome|Naloxone|Naloxone HCl 0.2 mg intravenously followed by additional 0.6 mg naloxone HCl intravenously, each dose followed by an assessment for signs and symptoms of opioid withdrawal in naloxone challenge phase.
143225|NCT01775189|O7|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143226|NCT01775189|O6|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143227|NCT01775189|O5|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143228|NCT01775189|O4|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143229|NCT01775189|O3|Outcome|Placebo Oxycodone HCl|Single dose of placebo matched to oxycodone HCl 30 mg crushed tablet intranasally on either of 2 days in drug discrimination phase.
143230|NCT01775189|O2|Outcome|Oxycodone HCl 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally on either of 2 days in drug discrimination phase.
143231|NCT01775189|O1|Outcome|Naloxone|Naloxone HCl 0.2 mg intravenously followed by additional 0.6 mg naloxone HCl intravenously, each dose followed by an assessment for signs and symptoms of opioid withdrawal in naloxone challenge phase.
143232|NCT01775189|O1|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143233|NCT01775189|O1|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143234|NCT01775189|O1|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143240|NCT01775189|O1|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143241|NCT01775189|O1|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143242|NCT01775189|O2|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143243|NCT01775189|O1|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143244|NCT01775189|O1|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143245|NCT01775189|O2|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143246|NCT01775189|O1|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143247|NCT01775189|O1|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143248|NCT01775189|O2|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143249|NCT01775189|O1|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143250|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143251|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143252|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143253|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143254|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143255|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143256|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143257|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143258|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143259|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143260|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143261|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143262|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143263|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143264|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143265|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143266|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143267|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143268|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143269|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143270|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143271|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143272|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143273|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143274|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143275|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143276|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143277|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143278|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143279|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143280|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143281|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143282|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143283|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143284|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143285|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143286|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143287|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143288|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143289|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143290|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143291|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143292|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143293|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143294|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143295|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143296|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143297|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143298|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143299|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143300|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143301|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143302|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143303|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143304|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143305|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143306|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143307|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143308|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143309|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143310|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143311|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143312|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143313|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143314|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143315|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143316|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143317|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143318|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143319|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143320|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143321|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143322|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143480|NCT01774981|B9|Baseline|Total|Total of all reporting groups
143323|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143324|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143325|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143326|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143327|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143328|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143329|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143330|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143331|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143332|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143333|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143334|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143335|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143336|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143337|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143338|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143339|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143340|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143341|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143342|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143343|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143344|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143345|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143346|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143347|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143348|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143349|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143350|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143351|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143352|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143353|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143354|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143355|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143356|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143357|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143358|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143359|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143360|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143361|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143362|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143363|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143822|NCT01773122|B5|Baseline|Total|Total of all reporting groups
143364|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143365|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143366|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143367|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143368|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143369|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143370|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143371|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143372|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143373|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143374|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143375|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143376|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143377|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143378|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143379|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143380|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143381|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143382|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143383|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143384|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143385|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143386|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143387|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143388|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143389|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143390|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143391|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143392|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143393|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143394|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143395|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143396|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143397|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143398|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143399|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143400|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143401|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143402|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143403|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143404|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
147508|NCT01761565|O1|Outcome|Single Dose of SUF NT 15 mcg|
143405|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143406|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143407|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143408|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143409|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143410|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143411|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143412|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143413|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143414|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143415|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
143416|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143417|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
143418|NCT01775189|E7|Reported Event|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143419|NCT01775189|E6|Reported Event|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
143420|NCT01775189|E5|Reported Event|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143421|NCT01775189|E4|Reported Event|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
143422|NCT01775189|E3|Reported Event|Placebo Oxycodone HCl|Single dose of placebo matched to oxycodone HCl 30 mg crushed tablet intranasally on either of 2 days in drug discrimination phase.
143423|NCT01775189|E2|Reported Event|Oxycodone HCl 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally on either of 2 days in drug discrimination phase.
143424|NCT01775189|E1|Reported Event|Naloxone|Naloxone HCl 0.2 mg intravenously followed by additional 0.6 mg naloxone HCl intravenously, each dose followed by an assessment for signs and symptoms of opioid withdrawal in naloxone challenge phase.
143425|NCT01775137|B1|Baseline|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
143426|NCT01775137|P1|Participant Flow|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) twice daily (bid) via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
143427|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
143428|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
143429|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
143430|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
143431|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
143481|NCT01774981|B8|Baseline|750 mg LY3016859 (Part B)|Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
164259|NCT01697501|O3|Outcome|"GG"|at IL28B genotype rs8099917
143432|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
143433|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
143434|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
143435|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
143436|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
143437|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
143438|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
143439|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
143440|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
143441|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
143442|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
143443|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
143444|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) twice daily (bid) via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
143445|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
143446|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
143447|NCT01775137|E3|Reported Event|Overall|All participants who inhaled tobramycin inhalation powder during both core and extension study.
143448|NCT01775137|E2|Reported Event|Extension|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T-326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid). The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
143449|NCT01775137|E1|Reported Event|Core|Eligible participants were assigned to four capsules of TIP at 28 mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose = 224 mg tobramycin (112 mg b.i.d.). These 56 days represented 1 cycle of therapy during core study.
143450|NCT01775124|B3|Baseline|Total|Total of all reporting groups
143451|NCT01775124|B2|Baseline|Ranibizumab 0.5 mg PRN|PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
143452|NCT01775124|B1|Baseline|Ranibizumab 0.5 mg Monthly|Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
143453|NCT01775124|P2|Participant Flow|Ranibizumab 0.5 mg PRN|PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
143454|NCT01775124|P1|Participant Flow|Ranibizumab 0.5 mg Monthly|Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
143455|NCT01775124|O2|Outcome|Ranibizumab 0.5 mg PRN|PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
143456|NCT01775124|O1|Outcome|Ranibizumab 0.5 mg Monthly|Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
143457|NCT01775124|O2|Outcome|Ranibizumab 0.5 mg PRN|PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
143458|NCT01775124|O1|Outcome|Ranibizumab 0.5 mg Monthly|Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
143459|NCT01775124|O1|Outcome|Ranibizumab 0.5 mg PRN|PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
143460|NCT01775124|O2|Outcome|Ranibizumab 0.5 mg PRN|PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
143461|NCT01775124|O1|Outcome|Ranibizumab 0.5 mg Monthly|Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
143462|NCT01775124|O2|Outcome|Ranibizumab 0.5 mg PRN|PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
143463|NCT01775124|O1|Outcome|Ranibizumab 0.5 mg Monthly|Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
143464|NCT01775124|O2|Outcome|Ranibizumab 0.5 mg PRN|PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
143465|NCT01775124|O1|Outcome|Ranibizumab 0.5 mg Monthly|Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
143466|NCT01775124|O2|Outcome|Ranibizumab 0.5 mg PRN|PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
143467|NCT01775124|O1|Outcome|Ranibizumab 0.5 mg Monthly|Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
143468|NCT01775124|O2|Outcome|Ranibizumab 0.5 mg PRN|PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
143469|NCT01775124|O1|Outcome|Ranibizumab 0.5 mg Monthly|Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
143470|NCT01775124|O2|Outcome|Ranibizumab 0.5 mg PRN|PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
143471|NCT01775124|O1|Outcome|Ranibizumab 0.5 mg Monthly|Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
143472|NCT01775124|O2|Outcome|Ranibizumab 0.5 mg PRN|PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
143473|NCT01775124|O1|Outcome|Ranibizumab 0.5 mg Monthly|Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
143474|NCT01775124|O2|Outcome|Ranibizumab 0.5 mg PRN|PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
143475|NCT01775124|O1|Outcome|Ranibizumab 0.5 mg Monthly|Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
143476|NCT01775124|O2|Outcome|Ranibizumab 0.5 mg PRN|PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
143477|NCT01775124|O1|Outcome|Ranibizumab 0.5 mg Monthly|Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
143478|NCT01775124|E2|Reported Event|Ranibizumab 0.5 mg PRN|PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
143479|NCT01775124|E1|Reported Event|Ranibizumab 0.5 mg Monthly|Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
143482|NCT01774981|B7|Baseline|250 mg LY3016859 (Part B)|Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143483|NCT01774981|B6|Baseline|50 mg LY3016859 (Part B)|Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143484|NCT01774981|B5|Baseline|Placebo (Part B)|Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143485|NCT01774981|B4|Baseline|750 mg LY3016859 (Part A)|Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
143486|NCT01774981|B3|Baseline|100 mg LY3016859 (Part A)|Part A:100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
143487|NCT01774981|B2|Baseline|10 mg LY3016859 (Part A)|Part A: 10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
143488|NCT01774981|B1|Baseline|Placebo (Part A)|Part A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4.
143489|NCT01774981|P8|Participant Flow|750 mg LY3016859 (Part B)|Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143490|NCT01774981|P7|Participant Flow|250 mg LY3016859 (Part B)|Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143491|NCT01774981|P6|Participant Flow|50 mg LY3016859 (Part B)|Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143492|NCT01774981|P5|Participant Flow|Placebo (Part B)|Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143493|NCT01774981|P4|Participant Flow|750 mg LY3016859 (Part A)|Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
143494|NCT01774981|P3|Participant Flow|100 mg LY3016859 (Part A)|Part A: 100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
143495|NCT01774981|P2|Participant Flow|10 mg LY3016859 (Part A)|Part A: 10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
143496|NCT01774981|P1|Participant Flow|Placebo (Part A)|Part A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4.
143497|NCT01774981|O4|Outcome|750 mg LY3016859 (Part B)|Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143498|NCT01774981|O3|Outcome|250 mg LY3016859 (Part B)|Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143499|NCT01774981|O2|Outcome|50 mg LY3016859 (Part B)|Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143500|NCT01774981|O1|Outcome|Placebo (Part B)|Part B:Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143501|NCT01774981|O4|Outcome|750 mg LY3016859 (Part B)|Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143502|NCT01774981|O3|Outcome|250 mg LY3016859 (Part B)|Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143503|NCT01774981|O2|Outcome|50 mg LY3016859 (Part B)|Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143504|NCT01774981|O1|Outcome|Placebo (Part B)|Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143505|NCT01774981|O8|Outcome|750 mg LY3016859 (Part B)|Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143506|NCT01774981|O7|Outcome|250 mg LY3016859 (Part B)|Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143507|NCT01774981|O6|Outcome|50 mg LY3016859 (Part B)|Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143508|NCT01774981|O5|Outcome|Placebo (Part B)|Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143509|NCT01774981|O4|Outcome|750 mg LY3016859 (Part A)|Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
143510|NCT01774981|O3|Outcome|100 mg LY3016859 (Part A)|Part A: 100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
143511|NCT01774981|O2|Outcome|10 mg LY3016859 (Part A)|Part A:10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
143512|NCT01774981|O1|Outcome|Placebo (Part A)|Part A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4.
143513|NCT01774981|O4|Outcome|750 mg LY3016859 (Part B)|Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143514|NCT01774981|O3|Outcome|250 mg LY3016859 (Part B)|Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143515|NCT01774981|O2|Outcome|50 mg LY3016859 (Part B)|Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143516|NCT01774981|O1|Outcome|Placebo (Part B)|Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143517|NCT01774981|E8|Reported Event|750 mg LY3016859 (Part B)|Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143518|NCT01774981|E7|Reported Event|250 mg LY3016859 (Part B)|Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143519|NCT01774981|E6|Reported Event|50 mg LY3016859 (Part B)|Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143520|NCT01774981|E5|Reported Event|Placebo (Part B)|Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
143521|NCT01774981|E4|Reported Event|750 mg LY3016859 (Part A)|Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
143522|NCT01774981|E3|Reported Event|100 mg LY3016859 (Part A)|Part A: 100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
143523|NCT01774981|E2|Reported Event|10 mg LY3016859 (Part A)|Part A:10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
143524|NCT01774981|E1|Reported Event|Placebo (Part A)|Part A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4.
143525|NCT01774968|B3|Baseline|Total|Total of all reporting groups
143526|NCT01774968|B2|Baseline|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
143527|NCT01774968|B1|Baseline|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
143528|NCT01774968|P2|Participant Flow|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, two times a day (BID) for 24 weeks.
143529|NCT01774968|P1|Participant Flow|Human Regular U-500 Insulin TID|Human Regular U-500 Insulin (U-500R) titrated based on blood glucose readings, administered subcutaneously (SC), three times a day (TID) for 24 weeks.
143530|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
143531|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
143532|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
143533|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
143534|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
143535|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
143536|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
143537|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
143538|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
143539|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
143540|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
143541|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
143542|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
143543|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
143544|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
143545|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
143546|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
143547|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
143548|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
143549|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
143550|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
143551|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
143552|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
143553|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
143554|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
143555|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
143556|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
143557|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
143558|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
143559|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
143560|NCT01774968|E2|Reported Event|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
143561|NCT01774968|E1|Reported Event|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
143562|NCT01774929|B1|Baseline|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
143563|NCT01774929|P1|Participant Flow|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
143564|NCT01774929|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
143565|NCT01774929|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
143566|NCT01774929|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
143567|NCT01774929|E1|Reported Event|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
143568|NCT01774903|B1|Baseline|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
143569|NCT01774903|P1|Participant Flow|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
147509|NCT01761565|E2|Reported Event|40 Consecutive Doses of SUF NT 15 mcg|
143570|NCT01774903|O1|Outcome|TTS-fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
143571|NCT01774903|O1|Outcome|TTS-fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
143572|NCT01774903|O1|Outcome|TTS-fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
143573|NCT01774903|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
143574|NCT01774903|E1|Reported Event|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
143575|NCT01774851|B3|Baseline|Total|Total of all reporting groups
143576|NCT01774851|B2|Baseline|Experimental Group|MM-111 + trastuzumab + paclitaxel
143577|NCT01774851|B1|Baseline|Control Group|Trastuzumab + paclitaxel
143578|NCT01774851|P2|Participant Flow|Experimental Group|MM-111 + trastuzumab + paclitaxel
143579|NCT01774851|P1|Participant Flow|Control Group|Paclitaxel + Trastuzumab
143580|NCT01774851|O2|Outcome|Experimental Group|MM-111 + trastuzumab + paclitaxel
143581|NCT01774851|O1|Outcome|Control Group|trastuzumab + paclitaxel
143582|NCT01774851|E2|Reported Event|Experimental Group|MM-111 + trastuzumab + paclitaxel
143583|NCT01774851|E1|Reported Event|Control Group|trastuzumab + paclitaxel
143584|NCT01774786|B3|Baseline|Total|Total of all reporting groups
143585|NCT01774786|B2|Baseline|Placebo + Trastuzumab + Chemotherapy|Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143586|NCT01774786|B1|Baseline|Pertuzumab + Trastuzumab + Chemotherapy|Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143587|NCT01774786|P2|Participant Flow|Placebo + Trastuzumab + Chemotherapy|Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143588|NCT01774786|P1|Participant Flow|Pertuzumab + Trastuzumab + Chemotherapy|Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143589|NCT01774786|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143590|NCT01774786|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143591|NCT01774786|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143592|NCT01774786|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143593|NCT01774786|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143594|NCT01774786|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143595|NCT01774786|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143655|NCT01774344|O1|Outcome|Placebo|Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
143799|NCT01773291|O2|Outcome|Laser Acupuncture|"laser acupuncture on GV26 and 12 Well points~laser acupuncture: laser acupuncture on GV26 and 12 Well points"
143596|NCT01774786|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143597|NCT01774786|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143598|NCT01774786|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143599|NCT01774786|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143600|NCT01774786|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143601|NCT01774786|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143602|NCT01774786|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143603|NCT01774786|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143604|NCT01774786|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143605|NCT01774786|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143606|NCT01774786|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143607|NCT01774786|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143608|NCT01774786|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143609|NCT01774786|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143610|NCT01774786|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143611|NCT01774786|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143720|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
143612|NCT01774786|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143613|NCT01774786|E2|Reported Event|Placebo + Trastuzumab + Chemotherapy|Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143614|NCT01774786|E1|Reported Event|Pertuzumab + Trastuzumab + Chemotherapy|Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
143615|NCT01774604|B3|Baseline|Total|Total of all reporting groups
143616|NCT01774604|B2|Baseline|Placebo|"Placebo suppositories (#2)~Placebo"
143617|NCT01774604|B1|Baseline|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
143618|NCT01774604|P2|Participant Flow|Placebo|"Placebo suppositories (#2)~Placebo"
143619|NCT01774604|P1|Participant Flow|Indomethacin|"Indomethacin 100 mg Per Rectum (PR) x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
143620|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)~Placebo"
143621|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
143622|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)~Placebo"
143623|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
143624|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)~Placebo"
143625|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
143626|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)~Placebo"
143627|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
143628|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)~Placebo"
143629|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
143630|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)~Placebo"
143631|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
143632|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)~Placebo"
143633|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
143634|NCT01774604|E2|Reported Event|Placebo|"Placebo suppositories (#2)~Placebo"
143635|NCT01774604|E1|Reported Event|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
143636|NCT01774591|B3|Baseline|Total|Total of all reporting groups
143637|NCT01774591|B2|Baseline|Placebo|Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months.
143638|NCT01774591|B1|Baseline|Azilsartan Medoximil.|Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day and followed for six months.
143639|NCT01774591|P2|Participant Flow|Placebo|Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months.
143640|NCT01774591|P1|Participant Flow|Azilsartan Medoximil.|Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day and followed for six months.
143641|NCT01774591|O2|Outcome|Placebo|Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months.
143642|NCT01774591|O1|Outcome|Azilsartan Medoximil.|Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day and followed for six months.
143643|NCT01774591|O2|Outcome|Placebo|Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months.
143644|NCT01774591|O1|Outcome|Azilsartan Medoximil.|Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day and followed for six months.
143645|NCT01774591|O2|Outcome|Placebo|Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months.
143646|NCT01774591|O1|Outcome|Azilsartan Medoximil.|Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day and followed for six months.
143647|NCT01774591|E2|Reported Event|Placebo|Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months.
143648|NCT01774591|E1|Reported Event|Azilsartan Medoximil.|Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day and followed for six months.
143649|NCT01774344|B3|Baseline|Total|Total of all reporting groups
143650|NCT01774344|B2|Baseline|Regorafenib 160 mg (BAY73-4506)|Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
143651|NCT01774344|B1|Baseline|Placebo|Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
143652|NCT01774344|P2|Participant Flow|Regorafenib 160 mg (BAY73-4506)|Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
143653|NCT01774344|P1|Participant Flow|Placebo|Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
143654|NCT01774344|O2|Outcome|Regorafenib 160 mg (BAY73-4506)|Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
143656|NCT01774344|O2|Outcome|Regorafenib 160 mg (BAY73-4506)|Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
143657|NCT01774344|O1|Outcome|Placebo|Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
143658|NCT01774344|O2|Outcome|Regorafenib 160 mg (BAY73-4506)|Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
143659|NCT01774344|O1|Outcome|Placebo|Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
143660|NCT01774344|O2|Outcome|Regorafenib 160 mg (BAY73-4506)|Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
143661|NCT01774344|O1|Outcome|Placebo|Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
143662|NCT01774344|O2|Outcome|Regorafenib 160 mg (BAY73-4506)|Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
143663|NCT01774344|O1|Outcome|Placebo|Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
143664|NCT01774344|E2|Reported Event|Regorafenib 160mg (BAY73-4506)|Subjects received regorafenib 160 mg (4 *40 mg tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
143665|NCT01774344|E1|Reported Event|Placebo|Subjects received placebo matched to regorafenib tablets orally every day for 3 weeks followed by 1 week off treatment plus BSC.
143666|NCT01774305|B3|Baseline|Total|Total of all reporting groups
143667|NCT01774305|B2|Baseline|Saline|We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
143668|NCT01774305|B1|Baseline|Dexmedetomidine|We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
143669|NCT01774305|P2|Participant Flow|Saline|We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
143670|NCT01774305|P1|Participant Flow|Dexmedetomidine|We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
143671|NCT01774305|O2|Outcome|Saline|We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
143672|NCT01774305|O1|Outcome|Dexmedetomidine|We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
143673|NCT01774305|O2|Outcome|Saline|We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
143674|NCT01774305|O1|Outcome|Dexmedetomidine|We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
143675|NCT01774305|E2|Reported Event|Saline|We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
143676|NCT01774305|E1|Reported Event|Dexmedetomidine|We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
143677|NCT01774253|B1|Baseline|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
143678|NCT01774253|P1|Participant Flow|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
143679|NCT01774253|O1|Outcome|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
143680|NCT01774253|O1|Outcome|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
143681|NCT01774253|O1|Outcome|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
143682|NCT01774253|O1|Outcome|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
143683|NCT01774253|O1|Outcome|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
143684|NCT01774253|E1|Reported Event|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
143685|NCT01774149|B3|Baseline|Total|Total of all reporting groups
143686|NCT01774149|B2|Baseline|Diastat|"Few Touch Application with Diastat module turned on in week 4 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
143687|NCT01774149|B1|Baseline|Delayed Diastat|"Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
143688|NCT01774149|P2|Participant Flow|Diastat|"Few Touch Application with Diastat module turned on in week 4 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
143797|NCT01773291|P1|Participant Flow|Acupuncture|"acupuncture on Shuigou (GV26) and 12 Well points~acupuncture: acupuncture on GV26 and 12 Well points"
143689|NCT01774149|P1|Participant Flow|Delayed Diastat|"Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
143690|NCT01774149|O2|Outcome|Diastat|"Few Touch Application with Diastat module turned on in week 4 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
143691|NCT01774149|O1|Outcome|Delayed Diastat|"Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
143692|NCT01774149|O2|Outcome|Diastat|"Few Touch Application with Diastat module turned on in week 4 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
143693|NCT01774149|O1|Outcome|Delayed Diastat|"Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
143694|NCT01774149|E2|Reported Event|Diastat|"Few Touch Application with Diastat module turned on in week 4 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
143695|NCT01774149|E1|Reported Event|Delayed Diastat|"Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
143696|NCT01774110|B1|Baseline|Early Standardized Task Training|"Persons in the experimental group will receive ESTT (early standardized task specific training) for gait treatment after stroke.~Early standardized task training: Early standardized task training is a treatment approach using treadmill training applied very early after stroke onset."
143697|NCT01774110|P1|Participant Flow|Early Standardized Task Training|"Persons in the experimental group will receive ESTT (early standardized task specific training) for gait treatment after stroke.~Early standardized task training: Early standardized task training is a treatment approach using treadmill training applied very early after stroke onset."
143698|NCT01774110|O1|Outcome|Early Standardized Treadmill Training|
143699|NCT01774110|O1|Outcome|Early Standardized Treadmill Training|
143700|NCT01774110|O1|Outcome|ESTT|
143701|NCT01774110|E1|Reported Event|ESTT|early standardized treadmill training
143702|NCT01774097|B3|Baseline|Total|Total of all reporting groups
143703|NCT01774097|B2|Baseline|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
143704|NCT01774097|B1|Baseline|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
143705|NCT01774097|P2|Participant Flow|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
143706|NCT01774097|P1|Participant Flow|ALDHbr|"Participants will receive ALDHbr via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr in the index calf and posterior, lower thigh"
143707|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
143708|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
143709|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
143710|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
143711|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
143712|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
143713|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
143714|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
143715|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
143716|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
143717|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
143718|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
143719|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
143798|NCT01773291|O3|Outcome|Control Group|"laser acupuncture without laser output in control group.~control: sham laser acupuncture"
143721|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
143722|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
143723|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
143724|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
143725|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
143726|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr in the index calf and posterior, lower thigh"
143727|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
143728|NCT01774097|O1|Outcome|ALDHbr|Participants will receive ALDHbr cells via intramuscular injection ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh
143729|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
143730|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
143731|NCT01774097|E2|Reported Event|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
143732|NCT01774097|E1|Reported Event|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
143733|NCT01774084|B3|Baseline|Total|Total of all reporting groups
143734|NCT01774084|B2|Baseline|Water|Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
143735|NCT01774084|B1|Baseline|PreOp, NutriciaNordica AB|PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
143736|NCT01774084|P2|Participant Flow|Water|Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
143737|NCT01774084|P1|Participant Flow|PreOp, NutriciaNordica AB|PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
143738|NCT01774084|O2|Outcome|Water|Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
143739|NCT01774084|O1|Outcome|PreOp, NutriciaNordica AB|PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
143740|NCT01774084|O2|Outcome|Water|Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
143741|NCT01774084|O1|Outcome|PreOp, NutriciaNordica AB|PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
143742|NCT01774084|E2|Reported Event|Water|Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
143743|NCT01774084|E1|Reported Event|PreOp, NutriciaNordica AB|PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
143744|NCT01774045|B3|Baseline|Total|Total of all reporting groups
143745|NCT01774045|B2|Baseline|Placebo Control|"Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.~Placebo"
143746|NCT01774045|B1|Baseline|PDC-1421|"Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.~PDC-1421"
143747|NCT01774045|P2|Participant Flow|Placebo Control|"Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.~Placebo"
143748|NCT01774045|P1|Participant Flow|PDC-1421|"Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.~PDC-1421"
143749|NCT01774045|O2|Outcome|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours.
143750|NCT01774045|O1|Outcome|PDC-1421|Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
143751|NCT01774045|O2|Outcome|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and and observation from baseline to the following 72 hours
143752|NCT01774045|O1|Outcome|PDC-1421|Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
147510|NCT01761565|E1|Reported Event|Single Dose of SUF NT 15 mcg|
143753|NCT01774045|O2|Outcome|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and and observation from baseline to the following 72 hours
143754|NCT01774045|O1|Outcome|PDC-1421|Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
143755|NCT01774045|O2|Outcome|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and and observation from baseline to the following 72 hours
143756|NCT01774045|O1|Outcome|PDC-1421|Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
143757|NCT01774045|O2|Outcome|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours.
143758|NCT01774045|O1|Outcome|PDC-1421|Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
143759|NCT01774045|E2|Reported Event|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
143760|NCT01774045|E1|Reported Event|PDC-1421|Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
143761|NCT01773954|B1|Baseline|Intravitreal Aflibercept|Intravitreal aflibercept on treat and extend schedule
143762|NCT01773954|P1|Participant Flow|Intravitreal Aflibercept|Intravitreal aflibercept on treat and extend schedule
143763|NCT01773954|O1|Outcome|Intravitreal Aflibercept|Intravitreal aflibercept on treat and extend schedule
143764|NCT01773954|O1|Outcome|Intravitreal Aflibercept|Intravitreal aflibercept on treat and extend schedule
143765|NCT01773954|E1|Reported Event|Intravitreal Aflibercept|Intravitreal aflibercept on treat and extend schedule
143766|NCT01773889|B1|Baseline|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a :
143767|NCT01773889|P1|Participant Flow|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a :
143768|NCT01773889|O1|Outcome|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a :
143769|NCT01773889|E1|Reported Event|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a :
143770|NCT01773473|B3|Baseline|Total|Total of all reporting groups
143771|NCT01773473|B2|Baseline|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
143772|NCT01773473|B1|Baseline|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
143773|NCT01773473|P2|Participant Flow|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
143774|NCT01773473|P1|Participant Flow|Insulin Lispro Mix25|Insulin Lispro Mix25 administered subcutaneously (SC) using prefilled pen twice daily for 26 weeks.
143775|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
143776|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
143777|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
143778|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
143779|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
143780|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
143781|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
143782|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
143783|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
143784|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
143785|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
143786|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
143787|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
143788|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
143789|NCT01773473|E2|Reported Event|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
143790|NCT01773473|E1|Reported Event|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
143791|NCT01773291|B4|Baseline|Total|Total of all reporting groups
143792|NCT01773291|B3|Baseline|Control Group|"laser acupuncture without laser output in control group.~control: sham laser acupuncture"
143793|NCT01773291|B2|Baseline|Laser Acupuncture|"laser acupuncture on GV26 and 12 Well points~laser acupuncture: laser acupuncture on GV26 and 12 Well points"
143794|NCT01773291|B1|Baseline|Acupuncture|"acupuncture on GV26 and 12 Well points~acupuncture: acupuncture on GV26 and 12 Well points"
143795|NCT01773291|P3|Participant Flow|Control Group|"laser acupuncture without laser output in control group.~control: sham laser acupuncture on GV26 and 12 Well points"
143796|NCT01773291|P2|Participant Flow|Laser Acupuncture|"laser acupuncture on GV26 and 12 Well points~laser acupuncture: laser acupuncture on GV26 and 12 Well points"
143801|NCT01773291|O3|Outcome|Control Group|"laser acupuncture without laser output in control group.~control: sham laser acupuncture on GV26 and 12 Well points"
143802|NCT01773291|O2|Outcome|Laser Acupuncture|"laser acupuncture on GV26 and 12 Well points~laser acupuncture: laser acupuncture on GV26 and 12 Well points"
143803|NCT01773291|O1|Outcome|Acupuncture|"acupuncture on GV26 and 12 Well points~acupuncture: acupuncture on GV26 and 12 Well points"
143804|NCT01773291|E3|Reported Event|Control Group|"laser acupuncture without laser output in control group.~control: sham laser acupuncture on GV26 and 12 Well points"
143805|NCT01773291|E2|Reported Event|Laser Acupuncture|"laser acupuncture on GV26 and 12 Well points~laser acupuncture: laser acupuncture on GV26 and 12 Well points"
143806|NCT01773291|E1|Reported Event|Acupuncture|"acupuncture on GV26 and 12 Well points~acupuncture: acupuncture on GV26 and 12 Well points"
143807|NCT01773226|B1|Baseline|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
143808|NCT01773226|P1|Participant Flow|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
143809|NCT01773226|O1|Outcome|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
143810|NCT01773226|O1|Outcome|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
143811|NCT01773226|O1|Outcome|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
143812|NCT01773226|O1|Outcome|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
143813|NCT01773226|O1|Outcome|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
143814|NCT01773226|E1|Reported Event|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
143815|NCT01773135|B3|Baseline|Total|Total of all reporting groups
143816|NCT01773135|B2|Baseline|Full Term Group|"pregnant healthy female aged from 17 to 35 who suffered from symptoms of threatened preterm labor.~investigators obtained a blood sample from all patient to measure the serum level of ACTH.~all patients with threatened preterm labor received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 60 - 160 mg/day (1-2 tablets 3 times daily) of slowly releasing nifedipine (epilat retard 20 mg tablet). The patients will also receive 6 mg dexamethasone every 12 hours for 4 doses. All women followed up till delivery.~this group delivered full term (after 37 weeks of gestation)"
143817|NCT01773135|B1|Baseline|Preterm Group|"pregnant healthy female aged from 17 to 35 who suffered from symptoms of threatened preterm labor.~investigators obtained a blood sample from all patient to measure the serum level of ACTH.~all patients with threatened preterm labor received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 60 - 160 mg/day (1-2 tablets 3 times daily) of slowly releasing nifedipine (epilat retard 20 mg tablet). The patients will also receive 6 mg dexamethasone every 12 hours for 4 doses. All women followed up till delivery.~this group delivered preterm (before 37 weeks of gestation)"
143818|NCT01773135|P1|Participant Flow|Pregnant Women With Threatened Preterm Labor|"pregnant healthy women aged from 17 to 35 who suffered from symptoms of threatened PTL in the form of Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation > 1 and < 4 cm, and/or Cervical effacement ≥ 80%.~then, collection of blood sample and tocolysis adminstration will be done~investigators obtained a blood sample from all patient to measure the serum level of ACTH.~all patients with threatened preterm labor will received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 1-2 tablets 4 times daily of slowly releasing nifedipine (epilat retard 20 mg tablet). All women will be followed up till delivery.~After delivery, investigators devide the pateints into 2 groups (full term delivery & preterm delivery) and investigators compare between these 2 groups by level of hormone."
143819|NCT01773135|O2|Outcome|Full Term Group|group of patients who delivered after 37 weeks of gestation
143820|NCT01773135|O1|Outcome|Preterm Group|group of patients who delivered before 37 weeks of gestation
143821|NCT01773135|E1|Reported Event|Pregnant Women With Threatened Preterm Labor|"pregnant healthy women aged from 17 to 35 who suffered from symptoms of threatened PTL in the form of Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation > 1 and < 4 cm, and/or Cervical effacement ≥ 80%.~then, collection of blood sample and tocolysis adminstration will be done~investigators obtained a blood sample from all patient to measure the serum level of ACTH.~all patients with threatened preterm labor will received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 1-2 tablets 4 times daily of slowly releasing nifedipine (epilat retard 20 mg tablet). All women will be followed up till delivery.~After delivery, investigators devide the pateints into 2 groups (full term delivery & preterm delivery) and investigators compare between these 2 groups by level of hormone."
143823|NCT01773122|B4|Baseline|Dapsone 5% Gel|Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
143824|NCT01773122|B3|Baseline|Dapsone Formulation C|Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
143825|NCT01773122|B2|Baseline|Dapsone Formulation B|Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
143826|NCT01773122|B1|Baseline|Dapsone Formulation A|Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
143827|NCT01773122|P4|Participant Flow|Dapsone 5% Gel|Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
143828|NCT01773122|P3|Participant Flow|Dapsone Formulation C|Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
143829|NCT01773122|P2|Participant Flow|Dapsone Formulation B|Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
143830|NCT01773122|P1|Participant Flow|Dapsone Formulation A|Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
143831|NCT01773122|O4|Outcome|Dapsone 5% Gel|Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
143832|NCT01773122|O3|Outcome|Dapsone Formulation C|Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
143833|NCT01773122|O2|Outcome|Dapsone Formulation B|Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
143834|NCT01773122|O1|Outcome|Dapsone Formulation A|Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
143835|NCT01773122|O4|Outcome|Dapsone 5% Gel|Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
143836|NCT01773122|O3|Outcome|Dapsone Formulation C|Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
143837|NCT01773122|O2|Outcome|Dapsone Formulation B|Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
143838|NCT01773122|O1|Outcome|Dapsone Formulation A|Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
143839|NCT01773122|E4|Reported Event|Dapsone 5% Gel|Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
143840|NCT01773122|E3|Reported Event|Dapsone Formulation C|Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
143841|NCT01773122|E2|Reported Event|Dapsone Formulation B|Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
143842|NCT01773122|E1|Reported Event|Dapsone Formulation A|Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
143843|NCT01773070|B1|Baseline|All Participants|Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
143844|NCT01773070|P1|Participant Flow|All Participants|Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic hepatitis C virus (HCV), followed for up to 3 years post-treatment.
143845|NCT01773070|O1|Outcome|All Participants|Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
143846|NCT01773070|O1|Outcome|All Participants|Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
143847|NCT01773070|O1|Outcome|All Participants|Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
143848|NCT01773070|O1|Outcome|All Participants|Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
143849|NCT01773070|O1|Outcome|All Participants|Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
143850|NCT01773070|E1|Reported Event|All Participants|Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
143851|NCT01772823|B3|Baseline|Total|Total of all reporting groups
143852|NCT01772823|B2|Baseline|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143853|NCT01772823|B1|Baseline|3MV Behavioral Intervention Group|3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143854|NCT01772823|P2|Participant Flow|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
144030|NCT01772537|B2|Baseline|Stent Graft Repair Isoflurane|"standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.~isoflurane"
144353|NCT01770509|O1|Outcome|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
143855|NCT01772823|P1|Participant Flow|3MV Behavioral Intervention Group|3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143856|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis"
143857|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|"3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks."
143858|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis"
143859|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|"3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks."
143860|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis"
143861|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|"3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks."
143862|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis"
143863|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|"3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks."
143864|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis"
143865|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|"3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks."
147519|NCT01761279|O2|Outcome|i-Scan|High definition white light endoscopy with i-Scan image enhancement
143866|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis"
143867|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|"3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks."
143868|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis"
143869|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|"3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks."
143870|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis"
143871|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|"3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks."
143872|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis"
143873|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|"3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks."
143874|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis"
143875|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|"3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks."
143876|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis"
147520|NCT01761279|O1|Outcome|HDWL|High Definition White Light Endoscopy
143877|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|"3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks."
143878|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis"
143879|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|"3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks."
143880|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis"
143881|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|"3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP~3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks."
143882|NCT01772823|O1|Outcome|All Study Participants|Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
143883|NCT01772823|O1|Outcome|All Study Participants|Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
143884|NCT01772823|O2|Outcome|Off Prep|Prematurely discontinued from the study agent
143885|NCT01772823|O1|Outcome|On Prep|Remained on study agent
143886|NCT01772823|O2|Outcome|Off Prep|Prematurely discontinued from the study agent
143887|NCT01772823|O1|Outcome|On Prep|Remained on study agent
143888|NCT01772823|O2|Outcome|Off Prep|Prematurely discontinued from the study agent
143889|NCT01772823|O1|Outcome|On Prep|Remained on study agent
143890|NCT01772823|O2|Outcome|Off Prep|Prematurely discontinued from the study agent
143891|NCT01772823|O1|Outcome|On Prep|Remained on study agent
143892|NCT01772823|O2|Outcome|Off Prep|Prematurely discontinued from the study agent
143893|NCT01772823|O1|Outcome|On Prep|Remained on study agent
143894|NCT01772823|O2|Outcome|Off Prep|Prematurely discontinued from the study agent
143895|NCT01772823|O1|Outcome|On Prep|Remained on study agent
143896|NCT01772823|O1|Outcome|All Study Participants|Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
143897|NCT01772823|O2|Outcome|Off Prep|Prematurely discontinued from the study agent
143898|NCT01772823|O1|Outcome|On Prep|Remained on study agent
143899|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143900|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143901|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143902|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143903|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143904|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143905|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143906|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143907|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143908|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143909|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143910|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143911|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143912|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143913|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143914|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143915|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143916|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143917|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
145362|NCT01766310|O2|Outcome|Folic Acid|"Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study~Folic Acid"
143918|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143919|NCT01772823|O1|Outcome|All Study Participants|Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
143920|NCT01772823|O1|Outcome|All Study Participants|Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
143921|NCT01772823|O1|Outcome|All Study Participants|Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
143922|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143923|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143924|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143925|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143926|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143927|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143928|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143929|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143930|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143931|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143932|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143933|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143934|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143935|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143936|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143937|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143938|NCT01772823|O2|Outcome|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143939|NCT01772823|O1|Outcome|3MV Behavioral Intervention Group|3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143940|NCT01772823|O1|Outcome|All Study Participants|Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
143941|NCT01772823|O1|Outcome|All Study Participants|Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
143942|NCT01772823|O1|Outcome|All Study Participants|Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
143943|NCT01772823|O1|Outcome|All Study Participants|Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
143944|NCT01772823|O1|Outcome|All Study Participants|Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
143945|NCT01772823|O1|Outcome|All Study Participants|Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
143946|NCT01772823|O1|Outcome|All Study Participants|Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
143947|NCT01772823|O1|Outcome|All Study Participants|Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
143948|NCT01772823|E2|Reported Event|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143949|NCT01772823|E1|Reported Event|3MV Behavioral Intervention Group|3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
143950|NCT01772758|B5|Baseline|Total|Total of all reporting groups
143951|NCT01772758|B4|Baseline|Healthy Controls|baseline measurements were done with no intervention
143952|NCT01772758|B3|Baseline|Protocol 2: BH4 (20mg)|"measurements at baseline and 3 hours following the single dose of 20mg/kg Kuvan® or sapropterin dihydrochloride which is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4).BH4 has been shown in past studies to increase NO bioavailability.~BH4: Kuvan® or sapropterin dihydrochloride is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Subjects will receive an oral dose of 20 mg/kg of Kuvan® (Biomarin Pharmaceuticals Inc.)"
143953|NCT01772758|B2|Baseline|Protocol 2: BH4 (5mg)|"measurements at baseline and 3 hours following the single dose of 5mg/kg Kuvan® or sapropterin dihydrochloride which is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4).BH4 has been shown in past studies to increase NO bioavailability.~BH4: Kuvan® or sapropterin dihydrochloride is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Subjects will receive an oral dose of 20 mg/kg of Kuvan® (Biomarin Pharmaceuticals Inc.)"
143954|NCT01772758|B1|Baseline|Protocol 1: AOC|"measurements at baseline and 2 hours following the antioxidant cocktail that is comprised of over the counter vitamins (vitamin C 1000mg, vitamin E 600 IU, and alpha lipoic acid 600 mg) that will be given in two doses, 30 minutes apart.~Vitamin C, 1000mg: Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID~Vitamin E, 600IU: Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID~Alpha Lipoic Acid, 600mg: Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID"
143955|NCT01772758|P4|Participant Flow|Healthy Controls|measurements were done with no intervention
143971|NCT01772654|P1|Participant Flow|Left Temporal Lobe Epilepsy Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
143956|NCT01772758|P3|Participant Flow|Protocol 2: BH4 (20mg)|"measurements at baseline and 3 hours following the single dose of 20mg/kg Kuvan® or sapropterin dihydrochloride which is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4).BH4 has been shown in past studies to increase NO bioavailability.~BH4: Kuvan® or sapropterin dihydrochloride is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Subjects will receive an oral dose of 20 mg/kg of Kuvan® (Biomarin Pharmaceuticals Inc.)"
143957|NCT01772758|P2|Participant Flow|Protocol 2: BH4 (5mg)|"measurements at baseline and 3 hours following the single dose of 5mg/kg Kuvan® or sapropterin dihydrochloride which is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4).BH4 has been shown in past studies to increase NO bioavailability.~BH4: Kuvan® or sapropterin dihydrochloride is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Subjects will receive an oral dose of 20 mg/kg of Kuvan® (Biomarin Pharmaceuticals Inc.)"
143958|NCT01772758|P1|Participant Flow|Protocol 1: AOC|"measurements at baseline and 2 hours following the antioxidant cocktail that is comprised of over the counter vitamins (vitamin C 1000mg, vitamin E 600 IU, and alpha lipoic acid 600 mg) that will be given in two doses, 30 minutes apart.~Vitamin C, 1000mg: Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID~Vitamin E, 600IU: Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID~Alpha Lipoic Acid, 600mg: Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID"
143959|NCT01772758|O4|Outcome|Healthy Controls|measurements were done with no intervention
143960|NCT01772758|O3|Outcome|Protocol 2: BH4 (20mg)|"measurements at baseline and 3 hours following the single dose of 20mg/kg Kuvan® or sapropterin dihydrochloride which is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4).BH4 has been shown in past studies to increase NO bioavailability.~BH4: Kuvan® or sapropterin dihydrochloride is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Subjects will receive an oral dose of 20 mg/kg of Kuvan® (Biomarin Pharmaceuticals Inc.)"
143961|NCT01772758|O2|Outcome|Protocol 2: BH4 (5mg)|"measurements at baseline and 3 hours following the single dose of 5mg/kg Kuvan® or sapropterin dihydrochloride which is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4).BH4 has been shown in past studies to increase NO bioavailability.~BH4: Kuvan® or sapropterin dihydrochloride is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Subjects will receive an oral dose of 20 mg/kg of Kuvan® (Biomarin Pharmaceuticals Inc.)"
143962|NCT01772758|O1|Outcome|Protocol 1: AOC|"measurements at baseline and 2 hours following the antioxidant cocktail that is comprised of over the counter vitamins (vitamin C 1000mg, vitamin E 600 IU, and alpha lipoic acid 600 mg) that will be given in two doses, 30 minutes apart.~Vitamin C, 1000mg: Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID~Vitamin E, 600IU: Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID~Alpha Lipoic Acid, 600mg: Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID"
143963|NCT01772758|E4|Reported Event|Tetrahydrobiopterin (BH4): 20mg|"measurements at baseline and 3 hours following the single dose of 20mg/kg Kuvan® or sapropterin dihydrochloride which is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4).BH4 has been shown in past studies to increase NO bioavailability.~BH4: Kuvan® or sapropterin dihydrochloride is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Subjects will receive an oral dose of 20 mg/kg of Kuvan® (Biomarin Pharmaceuticals Inc.)"
143964|NCT01772758|E3|Reported Event|Tetrahydrobiopterin (BH4): 5mg|"measurements at baseline and 3 hours following the single dose of 5mg/kg Kuvan® or sapropterin dihydrochloride which is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4).BH4 has been shown in past studies to increase NO bioavailability.~BH4: Kuvan® or sapropterin dihydrochloride is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Subjects will receive an oral dose of 20 mg/kg of Kuvan® (Biomarin Pharmaceuticals Inc.)"
143965|NCT01772758|E2|Reported Event|Antioxidant Cocktail: Healthy Controls|"measurements at baseline and 2 hours following the antioxidant cocktail that is comprised of over the counter vitamins (vitamin C 1000mg, vitamin E 600 IU, and alpha lipoic acid 600 mg) that will be given in two doses, 30 minutes apart.~Vitamin C, 1000mg: Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID"
143966|NCT01772758|E1|Reported Event|Antioxidant Cocktail: CF Patients|"measurements at baseline and 2 hours following the antioxidant cocktail that is comprised of over the counter vitamins (vitamin C 1000mg, vitamin E 600 IU, and alpha lipoic acid 600 mg) that will be given in two doses, 30 minutes apart.~Vitamin C, 1000mg: Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID~Vitamin E, 600IU: Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID~Alpha Lipoic Acid, 600mg: Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID"
143967|NCT01772654|B3|Baseline|Total|Total of all reporting groups
143968|NCT01772654|B2|Baseline|Control Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
143969|NCT01772654|B1|Baseline|Left Temporal Lobe Epilepsy Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
143970|NCT01772654|P2|Participant Flow|Control Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
144006|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
144007|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
144008|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
143972|NCT01772654|O2|Outcome|Control Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood. This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
143973|NCT01772654|O1|Outcome|Left Temporal Lobe Epilepsy Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
143974|NCT01772654|E2|Reported Event|Control Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
143975|NCT01772654|E1|Reported Event|Left Temporal Lobe Epilepsy Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
143976|NCT01772576|B1|Baseline|Reliance 4-Front|"Single arm, all patients will be implanted with the Reliance 4-Front lead~Reliance 4-Front lead implantation: The patients selected for participation should be from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
143977|NCT01772576|P1|Participant Flow|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead~Reliance 4-Front lead implantation: The patients selected for participation were from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
143978|NCT01772576|O1|Outcome|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead~Reliance 4-Front lead implantation: The patients selected for participation were from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
143979|NCT01772576|O1|Outcome|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead~Reliance 4-Front lead implantation: The patients selected for participation were from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
143980|NCT01772576|O1|Outcome|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead~Reliance 4-Front lead implantation: The patients selected for participation were from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
143981|NCT01772576|O1|Outcome|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead~Reliance 4-Front lead implantation: The patients selected for participation were from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
143982|NCT01772576|O1|Outcome|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead~Reliance 4-Front lead implantation: The patients selected for participation were from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
143983|NCT01772576|O1|Outcome|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead~Reliance 4-Front lead implantation: The patients selected for participation were from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
143984|NCT01772576|E1|Reported Event|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead~Reliance 4-Front lead implantation: The patients selected for participation were from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
143985|NCT01772550|B4|Baseline|Total|Total of all reporting groups
143986|NCT01772550|B3|Baseline|20 GA BD Nexiva Diffusics - Nonrandomized|
143987|NCT01772550|B2|Baseline|18 GA Conventional Catheter - Randomized|
143988|NCT01772550|B1|Baseline|20 GA BD Nexiva Diffusics - Randomized|
143989|NCT01772550|P3|Participant Flow|20 GA BD Nexiva Diffusics - Nonrandomized|Subjects whose veins are not suitable for an 18GA IV catheter will be assigned to this non-randomized arm. During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the 20GA fenestrated BD Nexiva Diffusics single port IV catheter
143990|NCT01772550|P2|Participant Flow|18 GA Conventional Catheter - Randomized|During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the non-fenestrated 18GA x 1.25 inch Smiths Medical Jelco IV catheter
143991|NCT01772550|P1|Participant Flow|20 GA BD Nexiva Diffusics - Randomized|During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the 20 GA fenestrated BD Nexiva Diffusics single port IV catheter
143992|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
143993|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
143994|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
143995|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
143996|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
143997|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
143998|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
143999|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
144000|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
144001|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
144002|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
144003|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
144004|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
144005|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
144031|NCT01772537|B1|Baseline|Stent Graft Repair Propofol|"Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.~Propofol: Intravenous anesthetic"
144032|NCT01772537|P3|Participant Flow|Open Repair|These patient will receive no intervention, just standard of care.
144033|NCT01772537|P2|Participant Flow|Stent Graft Repair Isoflurane|"standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.~isoflurane"
144034|NCT01772537|P1|Participant Flow|Stent Graft Repair Propofol|"Patients have a stent graft repair receiving intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.~Propofol: Intravenous anesthetic"
144035|NCT01772537|O2|Outcome|Isoflurane|"standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.~isoflurane"
144036|NCT01772537|O1|Outcome|Propofol|"Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.~Propofol: Intravenous anesthetic"
144037|NCT01772537|O3|Outcome|Stent Graft Aneurysm Repair Isoflurane|These are participants that received stenting of thoracoabdominal aneurysms instead of an open repair and received Isoflurane as their primary anesthetic.
144038|NCT01772537|O2|Outcome|Delerium Staus Post Stenting of Aneuryms Propofol|These are participants that received stenting of thoracoabdominal aneurysms instead of an open repair and received Propofol as their primary anesthetic.
144039|NCT01772537|O1|Outcome|Delirum Status Post Open Thoracoabdominal Aneurysm Repair|These are participants that received open thoracoabdominal aneurysm repair instead of aneurysm stenting.
144040|NCT01772537|O2|Outcome|Isoflurane|"standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.~isoflurane"
144041|NCT01772537|O1|Outcome|Propofol|"Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.~Propofol: Intravenous anesthetic"
144042|NCT01772537|O2|Outcome|Isoflurane|"standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.~isoflurane"
144043|NCT01772537|O1|Outcome|Propofol|"Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.~Propofol: Intravenous anesthetic"
144044|NCT01772537|E3|Reported Event|Open Thoracoabdominal Aneurysm Repair|These are patients that received open thoracabdominal aneurysm repair instead of aneurysm stenting.
144045|NCT01772537|E2|Reported Event|Stent Graft Repair Isoflurane|"standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.~isoflurane"
144046|NCT01772537|E1|Reported Event|Stent Graft Repair Propofol|"Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.~Propofol: Intravenous anesthetic"
144047|NCT01772368|B1|Baseline|All Participants|All subjects, regardless of the order of treatments to which they were randomized in this cross-over study.
144048|NCT01772368|P1|Participant Flow|All Participants|All subjects, regardless of the order of treatments to which they were randomized in this cross-over study.
144049|NCT01772368|O7|Outcome|Fp MDPI 50 mcg X 2 BID|Patients used 2 inhalations of Fp MDPI 50 mcg (100 mcg total dose) twice daily during the 'washout' between treatment periods, so adverse events during this treatment were assigned to Fp MDPI 50 mcg.
144050|NCT01772368|O6|Outcome|Advair Diskus 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.
144051|NCT01772368|O5|Outcome|FS MDPI 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.
144052|NCT01772368|O4|Outcome|FS MDPI 100/25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.
144053|NCT01772368|O3|Outcome|FS MDPI 100/12.5mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.
144054|NCT01772368|O2|Outcome|FS MDPI 100/6.25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.
144055|NCT01772368|O1|Outcome|Fp MDPI 100 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate.
144056|NCT01772368|O6|Outcome|Advair Diskus 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.
144057|NCT01772368|O5|Outcome|FS MDPI 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.
144058|NCT01772368|O4|Outcome|FS MDPI 100/25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.
144059|NCT01772368|O3|Outcome|FS MDPI 100/12.5mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.
144060|NCT01772368|O2|Outcome|FS MDPI 100/6.25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.
144061|NCT01772368|O1|Outcome|Fp MDPI 100 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate.
144062|NCT01772368|O6|Outcome|Advair Diskus 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.
144063|NCT01772368|O5|Outcome|FS MDPI 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.
144064|NCT01772368|O4|Outcome|FS MDPI 100/25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.
144065|NCT01772368|O3|Outcome|FS MDPI 100/12.5mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.
144066|NCT01772368|O2|Outcome|FS MDPI 100/6.25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.
144067|NCT01772368|O1|Outcome|Fp MDPI 100 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate.
144127|NCT01772147|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144068|NCT01772368|O6|Outcome|Advair Diskus 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.
144069|NCT01772368|O5|Outcome|FS MDPI 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.
144070|NCT01772368|O4|Outcome|FS MDPI 100/25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.
144071|NCT01772368|O3|Outcome|FS MDPI 100/12.5mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.
144072|NCT01772368|O2|Outcome|FS MDPI 100/6.25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.
144073|NCT01772368|O1|Outcome|Fp MDPI 100 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate.
144074|NCT01772368|O6|Outcome|Advair Diskus 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.
144075|NCT01772368|O5|Outcome|FS MDPI 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.
144076|NCT01772368|O4|Outcome|FS MDPI 100/25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.
144077|NCT01772368|O3|Outcome|FS MDPI 100/12.5mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.
144078|NCT01772368|O2|Outcome|FS MDPI 100/6.25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.
144079|NCT01772368|O1|Outcome|Fp MDPI 100 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate.
144080|NCT01772368|O6|Outcome|Advair Diskus 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.
144081|NCT01772368|O5|Outcome|FS MDPI 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.
144082|NCT01772368|O4|Outcome|FS MDPI 100/25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.
144083|NCT01772368|O3|Outcome|FS MDPI 100/12.5mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.
144084|NCT01772368|O2|Outcome|FS MDPI 100/6.25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.
144085|NCT01772368|O1|Outcome|Fp MDPI 100 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate.
144086|NCT01772368|E7|Reported Event|Fp MDPI 50 mcg X 2 BID|Patients used 2 inhalations of Fp MDPI 50 mcg (100 mcg total dose) twice daily during the 'washout' between treatment periods, so adverse events during this treatment were assigned to Fp MDPI 50 mcg.
144087|NCT01772368|E6|Reported Event|Advair Diskus 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.
144088|NCT01772368|E5|Reported Event|FS MDPI 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.
144089|NCT01772368|E4|Reported Event|FS MDPI 100/25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.
144090|NCT01772368|E3|Reported Event|FS MDPI 100/12.5mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.
144091|NCT01772368|E2|Reported Event|FS MDPI 100/6.25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.
144092|NCT01772368|E1|Reported Event|Fp MDPI 100 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate.
144093|NCT01772316|B1|Baseline|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
144094|NCT01772316|P1|Participant Flow|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 milligram (mg) given as 0.9 milliliter (mL) of a 180 milligram per milliliter (mg/mL) solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by subcutaneous (SC) injection and as a single fixed dose irrespective of body weight.
144095|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
144096|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
144097|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
144098|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
144099|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
144100|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
144101|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
144102|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
144103|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
144104|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
144105|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
144106|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
144107|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
144108|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
144109|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
144110|NCT01772316|E1|Reported Event|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
144111|NCT01772147|B4|Baseline|Total|Total of all reporting groups
144112|NCT01772147|B3|Baseline|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144113|NCT01772147|B2|Baseline|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144114|NCT01772147|B1|Baseline|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144115|NCT01772147|P3|Participant Flow|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144116|NCT01772147|P2|Participant Flow|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received umeclidinium bromide (UMEC) 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144117|NCT01772147|P1|Participant Flow|Placebo QD + FSC 250/50 µg BID|Participants received placebo once daily (QD) each morning via a dry powder inhaler (DPI) and FSC 250/50 µg twice daily (BID) (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144118|NCT01772147|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144119|NCT01772147|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144120|NCT01772147|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144121|NCT01772147|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144122|NCT01772147|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144123|NCT01772147|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144124|NCT01772147|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144125|NCT01772147|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144126|NCT01772147|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144128|NCT01772147|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144129|NCT01772147|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144130|NCT01772147|E3|Reported Event|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144131|NCT01772147|E2|Reported Event|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144132|NCT01772147|E1|Reported Event|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144133|NCT01772134|B4|Baseline|Total|Total of all reporting groups
144134|NCT01772134|B3|Baseline|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144135|NCT01772134|B2|Baseline|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144136|NCT01772134|B1|Baseline|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144137|NCT01772134|P3|Participant Flow|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144138|NCT01772134|P2|Participant Flow|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received umeclidinium bromide (UMEC) 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144139|NCT01772134|P1|Participant Flow|Placebo QD + FSC 250/50 µg BID|Participants received placebo once daily (QD) each morning via a dry powder inhaler (DPI) and fluticasone propionate and salmeterol (FSC) 250/50 micrograms (µg) twice daily (BID) (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144140|NCT01772134|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144141|NCT01772134|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144142|NCT01772134|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144143|NCT01772134|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144144|NCT01772134|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144145|NCT01772134|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144146|NCT01772134|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144147|NCT01772134|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144148|NCT01772134|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144149|NCT01772134|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144150|NCT01772134|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144151|NCT01772134|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144152|NCT01772134|E3|Reported Event|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144153|NCT01772134|E2|Reported Event|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144154|NCT01772134|E1|Reported Event|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
144155|NCT01771991|B3|Baseline|Total|Total of all reporting groups
144156|NCT01771991|B2|Baseline|Placebo Group|"Cetaphil cream~Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area."
144157|NCT01771991|B1|Baseline|Topical Sodermix Dismutase|"Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)~Topical Sodermix Dismutase in the form of Sodermix (SOD): Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area."
147521|NCT01761279|O2|Outcome|i-Scan|High definition white light endoscopy with i-Scan image enhancement
144158|NCT01771991|P2|Participant Flow|Placebo Group|"Cetaphil cream~Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area."
144159|NCT01771991|P1|Participant Flow|Topical Sodermix Dismutase|"Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)~Topical Sodermix Dismutase in the form of Sodermix (SOD): Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area."
144160|NCT01771991|O2|Outcome|Placebo Group|"Cetaphil cream~Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area."
144161|NCT01771991|O1|Outcome|Topical Sodermix Dismutase|"Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)~Topical Sodermix Dismutase in the form of Sodermix (SOD): Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area."
144162|NCT01771991|E2|Reported Event|Placebo Group|"Cetaphil cream~Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area."
144163|NCT01771991|E1|Reported Event|Topical Sodermix Dismutase|"Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)~Topical Sodermix Dismutase in the form of Sodermix (SOD): Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area."
144164|NCT01771965|B3|Baseline|Total|Total of all reporting groups
144165|NCT01771965|B2|Baseline|CB Intervention|"Cognitive Behavioral one-on-one single session administered by phone~CB Intervention: The Cognitive Behavioral (CB) intervention is a brief, manualized, tailored one-on-one single session lasting 45-60 minutes and administered by phone. An individual format was chosen to reduce the potential discomfort of stigma of individual concerns in the presence of others. The intervention targets a change in the beliefs that influence whether or not someone enters mental health or substance use treatment. During the session, participants will be given a brief introduction to CBT and informed that CBT is based on the theory that cognitions (i.e., thoughts/beliefs), feelings and behaviors all interact with each other;101, 102 therefore, thoughts about certain situations or things influence behavior. Since thoughts are modifiable, changing thoughts about situations may change behavior."
144166|NCT01771965|B1|Baseline|Usual Care|No intervention.
144167|NCT01771965|P2|Participant Flow|CB Intervention|"Cognitive Behavioral one-on-one single session administered by phone~CB Intervention: The Cognitive Behavioral (CB) intervention is a brief, manualized, tailored one-on-one single session lasting 45-60 minutes and administered by phone. An individual format was chosen to reduce the potential discomfort of stigma of individual concerns in the presence of others. The intervention targets a change in the beliefs that influence whether or not someone enters mental health or substance use treatment. During the session, participants will be given a brief introduction to CBT and informed that CBT is based on the theory that cognitions (i.e., thoughts/beliefs), feelings and behaviors all interact with each other;101, 102 therefore, thoughts about certain situations or things influence behavior. Since thoughts are modifiable, changing thoughts about situations may change behavior."
144168|NCT01771965|P1|Participant Flow|Usual Care|No intervention.
144169|NCT01771965|O2|Outcome|CB Intervention|"Cognitive Behavioral one-on-one single session administered by phone~CB Intervention: The Cognitive Behavioral (CB) intervention is a brief, manualized, tailored one-on-one single session lasting 45-60 minutes and administered by phone. An individual format was chosen to reduce the potential discomfort of stigma of individual concerns in the presence of others. The intervention targets a change in the beliefs that influence whether or not someone enters mental health or substance use treatment. During the session, participants will be given a brief introduction to CBT and informed that CBT is based on the theory that cognitions (i.e., thoughts/beliefs), feelings and behaviors all interact with each other;101, 102 therefore, thoughts about certain situations or things influence behavior. Since thoughts are modifiable, changing thoughts about situations may change behavior."
144170|NCT01771965|O1|Outcome|Usual Care|No intervention.
144171|NCT01771965|E2|Reported Event|CB Intervention|"Cognitive Behavioral one-on-one single session administered by phone~CB Intervention: The Cognitive Behavioral (CB) intervention is a brief, manualized, tailored one-on-one single session lasting 45-60 minutes and administered by phone. An individual format was chosen to reduce the potential discomfort of stigma of individual concerns in the presence of others. The intervention targets a change in the beliefs that influence whether or not someone enters mental health or substance use treatment. During the session, participants will be given a brief introduction to CBT and informed that CBT is based on the theory that cognitions (i.e., thoughts/beliefs), feelings and behaviors all interact with each other;101, 102 therefore, thoughts about certain situations or things influence behavior. Since thoughts are modifiable, changing thoughts about situations may change behavior."
144172|NCT01771965|E1|Reported Event|Usual Care|No intervention.
144173|NCT01771913|B3|Baseline|Total|Total of all reporting groups
144174|NCT01771913|B2|Baseline|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement~ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
144175|NCT01771913|B1|Baseline|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.~centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
144176|NCT01771913|P2|Participant Flow|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement~ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
144177|NCT01771913|P1|Participant Flow|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.~centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
144178|NCT01771913|O2|Outcome|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement~ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
144179|NCT01771913|O1|Outcome|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.~centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
144180|NCT01771913|O2|Outcome|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement~ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
144181|NCT01771913|O1|Outcome|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.~centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
144182|NCT01771913|O2|Outcome|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement~ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
144183|NCT01771913|O1|Outcome|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.~centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
144184|NCT01771913|E2|Reported Event|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement~ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
144185|NCT01771913|E1|Reported Event|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.~centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
144186|NCT01771666|B1|Baseline|ISB and IC-Green Dye|The dose of Isosulfan blue (ISB) dye is 3 to 5 mL and Indocyanine green solution will be started at 1 mg/mL. If fluorescence is not detected with this dose, then it will be increased by 50%. A gamma probe [Neoprobe 2010] will be used to localize the sentinel lymph nodes in the axilla.
144187|NCT01771666|P1|Participant Flow|ISB and IC-Green Dye|The dose of Isosulfan blue (ISB) dye is 3 to 5 mL and Indocyanine green solution will be started at 1 mg/mL. If fluorescence is not detected with this dose, then it will be increased by 50%. A gamma probe [Neoprobe 2010] will be used to localize the sentinel lymph nodes in the axilla.
144188|NCT01771666|O1|Outcome|ISB and IC-Green Dye|The dose of Isosulfan blue (ISB) dye is 3 to 5 mL and Indocyanine green solution will be started at 1 mg/mL. If fluorescence is not detected with this dose, then it will be increased by 50%. A gamma probe [Neoprobe 2010] will be used to localize the sentinel lymph nodes in the axilla.
144189|NCT01771666|O1|Outcome|ISB and IC-Green Dye|The dose of Isosulfan blue (ISB) dye is 3 to 5 mL and Indocyanine green solution will be started at 1 mg/mL. If fluorescence is not detected with this dose, then it will be increased by 50%. A gamma probe [Neoprobe 2010] will be used to localize the sentinel lymph nodes in the axilla.
144190|NCT01771666|E1|Reported Event|ISB and IC-Green Dye|The dose of Isosulfan blue (ISB) dye is 3 to 5 mL and Indocyanine green solution will be started at 1 mg/mL. If fluorescence is not detected with this dose, then it will be increased by 50%. A gamma probe [Neoprobe 2010] will be used to localize the sentinel lymph nodes in the axilla.
144191|NCT01771172|B1|Baseline|Acute Defibrillation Testing|
144192|NCT01771172|P1|Participant Flow|Acute Defibrillation Testing|
144193|NCT01771172|O1|Outcome|Acute Defibrillation Testing|
144194|NCT01771172|E1|Reported Event|Acute Defibrillation Testing|
144195|NCT01770860|B1|Baseline|4 Commercially-available Bandage and 1 Control|Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.
144252|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144196|NCT01770860|P1|Participant Flow|4 Commercially-available Bandage and 1 Control|Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.
144197|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
144198|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
144199|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
144200|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
144201|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
144202|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
144203|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
144204|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
144205|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
144206|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
144207|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
144208|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
144209|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
144210|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
144211|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
144212|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
144213|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
144214|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
144215|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
144216|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
144217|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
144218|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
144219|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
144220|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
144221|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
144222|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
144223|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
144224|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
144225|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
144226|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
144227|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
144228|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
144229|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
144230|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
144231|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
144232|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
144233|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
144234|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
144235|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
144236|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
144237|NCT01770860|E1|Reported Event|4 Commercially-available Bandage and 1 Control|Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.
144238|NCT01770743|B6|Baseline|Total|Total of all reporting groups
144239|NCT01770743|B5|Baseline|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
144240|NCT01770743|B4|Baseline|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144241|NCT01770743|B3|Baseline|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144242|NCT01770743|B2|Baseline|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144243|NCT01770743|B1|Baseline|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144244|NCT01770743|P5|Participant Flow|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
144245|NCT01770743|P4|Participant Flow|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144246|NCT01770743|P3|Participant Flow|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144247|NCT01770743|P2|Participant Flow|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144248|NCT01770743|P1|Participant Flow|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144249|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
144250|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144251|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
145763|NCT01765465|B2|Baseline|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months~Placebo"
144253|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144254|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
144255|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144256|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144257|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144258|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144259|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
144260|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144261|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144262|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144263|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144264|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
144265|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144266|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144267|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144268|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144269|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
144270|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144271|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144272|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144273|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144274|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
144275|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144276|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144277|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144278|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144279|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
144280|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144281|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144282|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144283|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144284|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
144285|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144286|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144287|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144288|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144289|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
144290|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144291|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144292|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144293|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144294|NCT01770743|E5|Reported Event|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
144295|NCT01770743|E4|Reported Event|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144296|NCT01770743|E3|Reported Event|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144297|NCT01770743|E2|Reported Event|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144298|NCT01770743|E1|Reported Event|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
144299|NCT01770691|B1|Baseline|TIPI Vaginal Pessary|"Each subject will use different SMD'S (Slightly modified designs) of the TIPI vaginal pessary.~TIPI vaginal pessary: TIPI vaginal pessary G3 model, and TIPI SMD's"
144300|NCT01770691|P1|Participant Flow|TIPI Vaginal Pessary|"Each subject will use different SMD'S (Slightly modified designs) of the TIPI vaginal pessary. Not all subjects will use all SMD'S~TIPI vaginal pessary: TIPI vaginal pessary G3 model, and TIPI SMD's"
144301|NCT01770691|O4|Outcome|Cleared TIPI Device (G3)|7 subjects used the cleared TIPI G3 for up to 8 hours
144302|NCT01770691|O3|Outcome|SMD 9|7 subjects used SMD 9 for up to 8 hours
144303|NCT01770691|O2|Outcome|SMD 12 2009|6 subjects used SMD 12 for up to 8 hours during 2009
144304|NCT01770691|O1|Outcome|SMD 12 2008|5 subjects used SMD 12 for up to 8 hours during 2008
144305|NCT01770691|E1|Reported Event|TIPI Vaginal Pessary|"Each subject will use different SMD'S (Slightly modified designs) of the TIPI vaginal pessary.~TIPI vaginal pessary: TIPI vaginal pessary G3 model, and TIPI SMD's"
144306|NCT01770652|B5|Baseline|Total|Total of all reporting groups
144307|NCT01770652|B4|Baseline|Severe Renal Impairment|"Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
144308|NCT01770652|B3|Baseline|Moderate Renal Impairment|"Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
144309|NCT01770652|B2|Baseline|Mild Renal Impairment|"Mild renal impairment defined as eGFR 60-89 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
144310|NCT01770652|B1|Baseline|Normal Hepatic Function (Healthy Volunteers)|"Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
144311|NCT01770652|P4|Participant Flow|Severe Renal Impairment|"Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
144312|NCT01770652|P3|Participant Flow|Moderate Renal Impairment|"Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
144313|NCT01770652|P2|Participant Flow|Mild Renal Impairment|"Mild renal impairment defined as eGFR 60-89 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
144314|NCT01770652|P1|Participant Flow|Normal Hepatic Function (Healthy Volunteers)|"Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
144315|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
144316|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
144317|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
144318|NCT01770652|O1|Outcome|Normal Renal Function|"Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
144319|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
144320|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
144321|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
144322|NCT01770652|O1|Outcome|Normal Renal Function|"Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
144323|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
144324|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
144325|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
144326|NCT01770652|O1|Outcome|Normal Renal Function|"Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
144327|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
144328|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
144329|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
144330|NCT01770652|O1|Outcome|Normal Renal Function|"Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
144331|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
144332|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
144333|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
144334|NCT01770652|O1|Outcome|Normal Renal Function|"Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
144335|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
144336|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
144337|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
144338|NCT01770652|O1|Outcome|Normal Renal Function|"Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
144339|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
144340|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
144341|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild renal impairment defined as eGFR 60-89 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
144342|NCT01770652|O1|Outcome|Normal Renal Function (Healthy Volunteers)|"Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
144343|NCT01770652|E4|Reported Event|Severe Renal Impairment|"Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
144344|NCT01770652|E3|Reported Event|Moderate Renal Impairment|"Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
144345|NCT01770652|E2|Reported Event|Mild Renal Impairment|"Mild renal impairment defined as eGFR 60-89 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
144346|NCT01770652|E1|Reported Event|Normal Hepatic Function (Healthy Volunteers)|"Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
144347|NCT01770509|B3|Baseline|Total|Total of all reporting groups
144348|NCT01770509|B2|Baseline|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
144349|NCT01770509|B1|Baseline|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
144350|NCT01770509|P2|Participant Flow|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
144351|NCT01770509|P1|Participant Flow|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
144352|NCT01770509|O2|Outcome|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
144354|NCT01770509|O2|Outcome|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
144355|NCT01770509|O1|Outcome|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
144356|NCT01770509|O2|Outcome|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
144357|NCT01770509|O1|Outcome|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
144358|NCT01770509|O2|Outcome|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
144359|NCT01770509|O1|Outcome|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
144360|NCT01770509|O2|Outcome|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
144361|NCT01770509|O1|Outcome|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
144362|NCT01770509|E2|Reported Event|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
144363|NCT01770509|E1|Reported Event|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
144364|NCT01770483|B3|Baseline|Total|Total of all reporting groups
144365|NCT01770483|B2|Baseline|Study Group|"Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~nitazoxanide : nitazoxanide 500mg twice daily~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
144366|NCT01770483|B1|Baseline|Control Group|"Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
144367|NCT01770483|P2|Participant Flow|Study Group|"Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~nitazoxanide : nitazoxanide 500mg twice daily~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
144368|NCT01770483|P1|Participant Flow|Control Group|"Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
144369|NCT01770483|O2|Outcome|Study Group|"Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~nitazoxanide : nitazoxanide 500mg twice daily~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
144370|NCT01770483|O1|Outcome|Control Group|"Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
144371|NCT01770483|O2|Outcome|Study Group|"Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~nitazoxanide : nitazoxanide 500mg twice daily~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
144372|NCT01770483|O1|Outcome|Control Group|"Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
144373|NCT01770483|E2|Reported Event|Study Group|"Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~nitazoxanide : nitazoxanide 500mg twice daily~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
144374|NCT01770483|E1|Reported Event|Control Group|"Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
144375|NCT01770431|B3|Baseline|Total|Total of all reporting groups
144376|NCT01770431|B2|Baseline|Bank-control Group|"Blank-control group, not taking Huaier Granule, other anticancer drugs, or immunomodulatory agents.~During the study, patients who need antiviral therapy, in both the test group and control group, can be treated according to the therapeutic principles.~Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po."
144377|NCT01770431|B1|Baseline|Huaier Granule Group|"Huaier Granule group; specifications: 20g / bag; manufacturer: Qidong Gaitianli Medicines Co., Ltd..~Administration: the Huaier Granule Electuary should be orally taken from the 15th day after surgery. Usage: Huaier Granule Electuary is continuously taken three times per day, 20g per time, until 96 weeks after surgery or until study termination. The subjects should not take any other anticancer drugs or immunomodulatory agents, except for Huaier Granule.~Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po."
144378|NCT01770431|P2|Participant Flow|Bank-control Group|"Blank-control group, not taking Huaier Granule, other anticancer drugs, or immunomodulatory agents.~During the study, patients who need antiviral therapy, in both the test group and control group, can be treated according to the therapeutic principles.~Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po."
144379|NCT01770431|P1|Participant Flow|Huaier Granule Group|"Huaier Granule group; specifications: 20g / bag; manufacturer: Qidong Gaitianli Medicines Co., Ltd..~Administration: the Huaier Granule Electuary should be orally taken from the 15th day after surgery. Usage: Huaier Granule Electuary is continuously taken three times per day, 20g per time, until 96 weeks after surgery or until study termination. The subjects should not take any other anticancer drugs or immunomodulatory agents, except for Huaier Granule.~Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po."
144380|NCT01770431|O2|Outcome|Bank-control Group|"Blank-control group, not taking Huaier Granule, other anticancer drugs, or immunomodulatory agents.~During the study, patients who need antiviral therapy, in both the test group and control group, can be treated according to the therapeutic principles."
144381|NCT01770431|O1|Outcome|Huaier Granule Group|"Huaier Granule group; specifications: 20g / bag; manufacturer: Qidong Gaitianli Medicines Co., Ltd..~Administration: the Huaier Granule Electuary should be orally taken from the 15th day after surgery. Usage: Huaier Granule Electuary is continuously taken three times per day, 20g per time, until 96 weeks after surgery or until study termination. The subjects should not take any other anticancer drugs or immunomodulatory agents, except for Huaier Granule.~Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po."
144382|NCT01770431|O2|Outcome|Bank-control Group|"Blank-control group, not taking Huaier Granule, other anticancer drugs, or immunomodulatory agents.~During the study, patients who need antiviral therapy, in both the test group and control group, can be treated according to the therapeutic principles.~Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po."
144383|NCT01770431|O1|Outcome|Huaier Granule Group|"Huaier Granule group; specifications: 20g / bag; manufacturer: Qidong Gaitianli Medicines Co., Ltd..~Administration: the Huaier Granule Electuary should be orally taken from the 15th day after surgery. Usage: Huaier Granule Electuary is continuously taken three times per day, 20g per time, until 96 weeks after surgery or until study termination. The subjects should not take any other anticancer drugs or immunomodulatory agents, except for Huaier Granule.~Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po."
144384|NCT01770431|E2|Reported Event|Bank-control Group|"Blank-control group, not taking Huaier Granule, other anticancer drugs, or immunomodulatory agents.~During the study, patients who need antiviral therapy, in both the test group and control group, can be treated according to the therapeutic principles.~Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po."
144385|NCT01770431|E1|Reported Event|Huaier Granule Group|"Huaier Granule group; specifications: 20g / bag; manufacturer: Qidong Gaitianli Medicines Co., Ltd..~Administration: the Huaier Granule Electuary should be orally taken from the 15th day after surgery. Usage: Huaier Granule Electuary is continuously taken three times per day, 20g per time, until 96 weeks after surgery or until study termination. The subjects should not take any other anticancer drugs or immunomodulatory agents, except for Huaier Granule.~Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po."
144386|NCT01770392|B1|Baseline|Overall Study|This was an open-label, two-period, fixed-sequence trial. During the first period 150 mg of nintedanib was administered orally in form of a soft gelatine capsule. In the second period, a single dose of 600 mg of rifampicin was administered orally via film-coated tablet every day for a week, then a single dose of nintedanib was administered. The administrations of nintedanib were separated by a washout period of at least 14 days.
144387|NCT01770392|P1|Participant Flow|Overall Study|This was an open-label, two-period, fixed-sequence trial. During the first period 150 mg of nintedanib was administered orally in form of a soft gelatine capsule. In the second period, a single dose of 600 mg of rifampicin was administered orally via film-coated tablet every day for a week, then a single dose of nintedanib was administered. The administrations of nintedanib were separated by a washout period of at least 14 days.
144388|NCT01770392|O2|Outcome|Nintedanib + Rifampicin|600 mg rifampicin was given every evening from Day -7 to Day -1, followed by a single dose of 150 mg nintedanib in the morning of Day 1.
144389|NCT01770392|O1|Outcome|Nintedanib|150 mg of nintedanib was given as a single dose on Day 1.
144390|NCT01770392|O2|Outcome|Nintedanib + Rifampicin|600 mg Rifampicin was given every evening from Day -7 to Day -1, followed by a single dose of 150 mg nintedanib in the morning of Day 1.
144391|NCT01770392|O1|Outcome|Nintedanib|150 mg of Nintedanib was given as a single dose on Day 1.
144392|NCT01770392|O2|Outcome|Nintedanib + Rifampicin|600 mg rifampicin was given every evening from Day -7 to Day -1, followed by a single dose of 150 mg nintedanib in the morning of Day 1.
144393|NCT01770392|O1|Outcome|Nintedanib|150 mg of nintedanib was given as a single dose on Day 1.
144394|NCT01770392|E4|Reported Event|Nintedanib + Rifampicin|600 mg rifampicin was given every evening from Day -7 to Day -1, followed by a single dose of 150 mg nintedanib in the morning of Day 1.
144395|NCT01770392|E3|Reported Event|Rifampicin|600 mg rifampicin was given every evening from Day -7 to Day -1
144396|NCT01770392|E2|Reported Event|Washout Period|washout period of at least 14 days between the administrations of nintedanib. During this period no trial drug was administered
144397|NCT01770392|E1|Reported Event|Nintedanib|150 mg of nintedanib was given as a single dose on Day 1.
144398|NCT01770379|B4|Baseline|Total|Total of all reporting groups
144399|NCT01770379|B3|Baseline|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
144400|NCT01770379|B2|Baseline|AIN457 150mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
144401|NCT01770379|B1|Baseline|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
144402|NCT01770379|P3|Participant Flow|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
144403|NCT01770379|P2|Participant Flow|AIN457 150mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
144404|NCT01770379|P1|Participant Flow|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
144405|NCT01770379|O3|Outcome|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
144406|NCT01770379|O2|Outcome|AIN457 150mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
144407|NCT01770379|O1|Outcome|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
144408|NCT01770379|O3|Outcome|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
144409|NCT01770379|O2|Outcome|AIN457 150 mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
144410|NCT01770379|O1|Outcome|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status
144411|NCT01770379|O3|Outcome|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
144412|NCT01770379|O2|Outcome|AIN457 150mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
144413|NCT01770379|O1|Outcome|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
144414|NCT01770379|O3|Outcome|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
144415|NCT01770379|O2|Outcome|AIN457 150mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
144416|NCT01770379|O1|Outcome|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
144417|NCT01770379|E3|Reported Event|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
144418|NCT01770379|E2|Reported Event|Any AIN457 150 mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
144419|NCT01770379|E1|Reported Event|Any AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
144420|NCT01770366|B3|Baseline|Total|Total of all reporting groups
144421|NCT01770366|B2|Baseline|Intervention Condition|"Intervention participants will receive the Weight and Exercise Lifestyle Support (WELS) intervention, which involves use of a wireless activity monitor and weight scale, as well as access to a patient portal website displaying data from these devices.~Weight and Exercise Lifestyle Support (WELS): Intervention patients will receive a suite of devices manufactured by the FitLinxx company, including their Pebble activity monitor, ActiScale weight scale, and access to their ActiHealth.com patient portal website. Intervention participations will be able to use the features of this website, including widgets displaying their device data as well as challenge invitations to interact with other participants, as desired."
144422|NCT01770366|B1|Baseline|Usual Care|"Patients will receive usual care from the post-surgical clinic team.~Usual Care"
144423|NCT01770366|P2|Participant Flow|Intervention Condition|"Intervention participants will receive the Weight and Exercise Lifestyle Support (WELS) intervention, which involves use of a wireless activity monitor and weight scale, as well as access to a patient portal website displaying data from these devices.~Weight and Exercise Lifestyle Support (WELS): Intervention patients will receive a suite of devices manufactured by the FitLinxx company, including their Pebble activity monitor, ActiScale weight scale, and access to their ActiHealth.com patient portal website. Intervention participations will be able to use the features of this website, including widgets displaying their device data as well as challenge invitations to interact with other participants, as desired."
144424|NCT01770366|P1|Participant Flow|Usual Care|"Patients will receive usual care from the post-surgical clinic team.~Usual Care"
144425|NCT01770366|O2|Outcome|Intervention Condition|"Intervention participants will receive the Weight and Exercise Lifestyle Support (WELS) intervention, which involves use of a wireless activity monitor and weight scale, as well as access to a patient portal website displaying data from these devices.~Weight and Exercise Lifestyle Support (WELS): Intervention patients will receive a suite of devices manufactured by the FitLinxx company, including their Pebble activity monitor, ActiScale weight scale, and access to their ActiHealth.com patient portal website. Intervention participations will be able to use the features of this website, including widgets displaying their device data as well as challenge invitations to interact with other participants, as desired."
144426|NCT01770366|O1|Outcome|Usual Care|"Patients will receive usual care from the post-surgical clinic team.~Usual Care"
144427|NCT01770366|E2|Reported Event|Intervention Condition|"Intervention participants will receive the Weight and Exercise Lifestyle Support (WELS) intervention, which involves use of a wireless activity monitor and weight scale, as well as access to a patient portal website displaying data from these devices.~Weight and Exercise Lifestyle Support (WELS): Intervention patients will receive a suite of devices manufactured by the FitLinxx company, including their Pebble activity monitor, ActiScale weight scale, and access to their ActiHealth.com patient portal website. Intervention participations will be able to use the features of this website, including widgets displaying their device data as well as challenge invitations to interact with other participants, as desired."
144428|NCT01770366|E1|Reported Event|Usual Care|"Patients will receive usual care from the post-surgical clinic team.~Usual Care"
144429|NCT01770314|B3|Baseline|Total|Total of all reporting groups
144430|NCT01770314|B2|Baseline|Control|The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.
144431|NCT01770314|B1|Baseline|Experimental|Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
144432|NCT01770314|P2|Participant Flow|Experimental|Participants were given instructions via email to review eleven online lessons about opioid medication safety. Instructions suggested that participants view one lesson per day for eleven consecutive days. Each educational lesson focused on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
144433|NCT01770314|P1|Participant Flow|Control|The control group was a waitlist control. Participants were given access to the experimental intervention program after the intervention period and follow up assessments were completed.
144434|NCT01770314|O2|Outcome|Control|The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.
144435|NCT01770314|O1|Outcome|Experimental|Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
144436|NCT01770314|O2|Outcome|Control|The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.
144437|NCT01770314|O1|Outcome|Experimental|Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
144438|NCT01770314|E2|Reported Event|Control|The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.
144439|NCT01770314|E1|Reported Event|Experimental|Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
144440|NCT01770145|B1|Baseline|APOKYN|"Subjects will complete an L-Dopa Baseline Period in which they record daily time to on following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatment Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record time to on following the APOKYN injection."
144441|NCT01770145|P1|Participant Flow|APOKYN|"Subjects will complete an L-Dopa Baseline Period in which they record daily time to on following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatment Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record time to on following the APOKYN injection."
144442|NCT01770145|O1|Outcome|APOKYN|"In the study, subjects will complete an L-Dopa Baseline Period in which they record daily time to on following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatment Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record time to on following the APOKYN injection."
144443|NCT01770145|O1|Outcome|APOKYN|"In the study, subjects will complete an L-Dopa Baseline Period in which they record daily time to on following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatment Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record time to on following the APOKYN injection."
144444|NCT01770145|E1|Reported Event|APOKYN|"In the study, subjects will complete an L-Dopa Baseline Period in which they record daily time to on following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatment Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record time to on following the APOKYN injection."
144445|NCT01769612|B1|Baseline|CL Detect Rapid Test and Microsopy Samples|"Samples taken to be evaluated in the CL Detect and Microscopy assays~No Intervention"
144446|NCT01769612|P1|Participant Flow|CL Detect Rapid Test and Microsopy Samples|"Samples taken to be evaluated in the CL Detect and Microscopy assays~No Intervention"
144447|NCT01769612|O3|Outcome|Culture|Data for Culture results
144448|NCT01769612|O2|Outcome|Microscopy|Data for Micrscopy
144449|NCT01769612|O1|Outcome|CL Detect Rapid Test|Data for CL Detect Rapid Test
144450|NCT01769612|E1|Reported Event|CL Detect Rapid Test and Microsopy Samples|"Samples taken to be evaluated in the CL Detect and Microscopy assays~No Intervention"
144451|NCT01769586|B3|Baseline|Total|Total of all reporting groups
144452|NCT01769586|B2|Baseline|Midazolam|"1.5 mg increments up to 3 times (maximum 4.5 mg)~Midazolam"
144453|NCT01769586|B1|Baseline|Diphenhydramine|"Increments of 25 mcg to maximum of 3 times (total 75 mcg)~Diphenhydramine"
144454|NCT01769586|P2|Participant Flow|Midazolam|"1.5 mg increments up to 3 times (maximum 4.5 mg)~Midazolam"
144455|NCT01769586|P1|Participant Flow|Diphenhydramine|"Increments of 25 mcg to maximum of 3 times (total 75 mcg)~Diphenhydramine"
144456|NCT01769586|O2|Outcome|Midazolam|"1.5 mg increments up to 3 times (maximum 4.5 mg)~Midazolam"
144457|NCT01769586|O1|Outcome|Diphenhydramine|"Increments of 25 mcg to maximum of 3 times (total 75 mcg)~Diphenhydramine"
144458|NCT01769586|E2|Reported Event|Midazolam|"1.5 mg increments up to 3 times (maximum 4.5 mg)~Midazolam"
144459|NCT01769586|E1|Reported Event|Diphenhydramine|"Increments of 25 mcg to maximum of 3 times (total 75 mcg)~Diphenhydramine"
144460|NCT01769508|B1|Baseline|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
144461|NCT01769508|P1|Participant Flow|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
144462|NCT01769508|O1|Outcome|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
144463|NCT01769508|O1|Outcome|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
144464|NCT01769508|O1|Outcome|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
144465|NCT01769508|O1|Outcome|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
144466|NCT01769508|O1|Outcome|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
144467|NCT01769508|O1|Outcome|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
144468|NCT01769508|E1|Reported Event|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
144469|NCT01769456|B1|Baseline|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
144470|NCT01769456|P1|Participant Flow|PCC Behavioral Intervention Group|PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
144471|NCT01769456|O1|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP)."
144472|NCT01769456|O1|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP)."
144570|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144473|NCT01769456|O1|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP)."
144474|NCT01769456|O1|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"
144475|NCT01769456|O1|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"
144476|NCT01769456|O1|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP)."
144477|NCT01769456|O1|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"
144478|NCT01769456|O1|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"
144479|NCT01769456|O1|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"
144480|NCT01769456|O1|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"
144481|NCT01769456|O1|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"
144482|NCT01769456|O1|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"
144483|NCT01769456|O1|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"
144484|NCT01769456|O1|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"
144485|NCT01769456|O1|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"
144486|NCT01769456|O1|Outcome|PCC Behavioral Intervention Group|"PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"
144487|NCT01769456|E1|Reported Event|PCC Behavioral Intervention Group|"PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP~PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.~Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"
144488|NCT01769443|B3|Baseline|Total|Total of all reporting groups
144489|NCT01769443|B2|Baseline|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
144490|NCT01769443|B1|Baseline|No Desensitization|No desensitization therapy pre-transplantation
144491|NCT01769443|P2|Participant Flow|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
144492|NCT01769443|P1|Participant Flow|No Desensitization|No desensitization therapy pre-transplantation
144493|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
144494|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
144495|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
144496|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
144497|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
144498|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
144499|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
144500|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
144501|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
144502|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
144537|NCT01769391|P1|Participant Flow|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 mg per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
147522|NCT01761279|O1|Outcome|HDWL|High Definition White Light Endoscopy
144503|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
144504|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
144505|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
144506|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
144507|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
144508|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
144509|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
144510|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
144511|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
144512|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
144513|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
144514|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
144515|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
144516|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
144517|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
144518|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
145764|NCT01765465|B1|Baseline|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months~Rowachol"
144519|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
144520|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
144521|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
144522|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
144523|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
144524|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
144525|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
144526|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
144527|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
144528|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
144529|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
144530|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
144531|NCT01769443|E2|Reported Event|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
144532|NCT01769443|E1|Reported Event|No Desensitization|No desensitization therapy pre-transplantation
144533|NCT01769391|B3|Baseline|Total|Total of all reporting groups
144534|NCT01769391|B2|Baseline|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
144535|NCT01769391|B1|Baseline|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m^2) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
144536|NCT01769391|P2|Participant Flow|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
144538|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
144539|NCT01769391|O2|Outcome|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.
144540|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 mg per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
144541|NCT01769391|O2|Outcome|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.
144542|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
144543|NCT01769391|O2|Outcome|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.
144544|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
144545|NCT01769391|O1|Outcome|Necitumumab + Paclitaxel+ Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
144546|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles."
144547|NCT01769391|O2|Outcome|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC=6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
144548|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle."
144549|NCT01769391|O2|Outcome|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
144550|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle."
144551|NCT01769391|E2|Reported Event|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
144552|NCT01769391|E1|Reported Event|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles."
144553|NCT01769378|B3|Baseline|Total|Total of all reporting groups
144554|NCT01769378|B2|Baseline|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144555|NCT01769378|B1|Baseline|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144556|NCT01769378|P2|Participant Flow|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144557|NCT01769378|P1|Participant Flow|Dulaglutide|Dulaglutide 1.5 milligram (mg) administered subcutaneously (SQ) once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144558|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144559|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144560|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144561|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144562|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144563|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144564|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144565|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144566|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144567|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144568|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144569|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144571|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144572|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144573|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144574|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144575|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144576|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144577|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144578|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144579|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144580|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144581|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144582|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144583|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144584|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144585|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144586|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144587|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144588|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144589|NCT01769378|E2|Reported Event|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144590|NCT01769378|E1|Reported Event|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
144591|NCT01769365|B4|Baseline|Total|Total of all reporting groups
144592|NCT01769365|B3|Baseline|7-day Standard Triple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days~7-day standard triple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days"
144593|NCT01769365|B2|Baseline|10-day Sequential Therapy|"pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days~10-day sequential therapy: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days"
144594|NCT01769365|B1|Baseline|7-day Quadruple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days~7-day quadruple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days"
144595|NCT01769365|P3|Participant Flow|7-day Standard Triple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days~7-day standard triple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days"
144596|NCT01769365|P2|Participant Flow|10-day Sequential Therapy|"pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days~10-day sequential therapy: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days"
144597|NCT01769365|P1|Participant Flow|7-day Quadruple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days~7-day quadruple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days"
144598|NCT01769365|O3|Outcome|7-day Standard Triple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days~7-day standard triple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days"
144599|NCT01769365|O2|Outcome|10-day Sequential Therapy|"pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days~10-day sequential therapy: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days"
144600|NCT01769365|O1|Outcome|7-day Quadruple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days~7-day quadruple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days"
144601|NCT01769365|E3|Reported Event|7-day Standard Triple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days~7-day standard triple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days"
144808|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
144602|NCT01769365|E2|Reported Event|10-day Sequential Therapy|"pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days~10-day sequential therapy: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days"
144603|NCT01769365|E1|Reported Event|7-day Quadruple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days~7-day quadruple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days"
144604|NCT01769352|B5|Baseline|Total|Total of all reporting groups
144605|NCT01769352|B4|Baseline|Post-Other Surgery Macular Edema- Group 2|Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hr (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
144606|NCT01769352|B3|Baseline|Post-Other Surgery Macular Edema- Group 1|Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
144607|NCT01769352|B2|Baseline|Post-Cataract Surgery Macular Edema- Group 2|Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hr (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
144608|NCT01769352|B1|Baseline|Post-Cataract Surgery Macular Edema- Group 1|Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
144609|NCT01769352|P4|Participant Flow|Post-Other Surgery CME (PredA Qid + Kelac Qid) - Group 2|"Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution four times a day (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)~PredA + Kelac: At week 12, patients will be determined to be resolved, improving/stabilized or treatment failures. Patients who have complete resolution of edema will begin treatment withdrawal. Improving/stabilizing patients will maintain current therapy. Treatment failure Group 2 patients will move to Group 3 to receive PredA q1h WA + Kelac qid starting at week 12."
144610|NCT01769352|P3|Participant Flow|Post-Other Surgery CME (PredA q1h + Kelac Qid) - Group 1|"Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)~PredA + Kelac: At week 12, patients will be determined to be resolved, improving/stabilized or treatment failures. Patients who have complete resolution of edema will begin treatment withdrawal. Improving/stabilizing patients will maintain current therapy. Treatment failure Group 1 patients will be exited from the trial so that alternative therapy can be given."
144611|NCT01769352|P2|Participant Flow|Post-Cataract Surgery CME (PredA Qid + Kelac Qid) - Group 2|"Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution four times a day (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)~PredA + Kelac: At week 12, patients will be determined to be resolved, improving/stabilized or treatment failures. Patients who have complete resolution of edema will begin treatment withdrawal. Improving/stabilizing patients will maintain current therapy. Treatment failure Group 2 patients will move to Group 3 to receive PredA q1h WA + Kelac qid starting at week 12."
144612|NCT01769352|P1|Participant Flow|Post-Cataract Surgery CME (PredAq1h+ Kelac Qid) - Group 1|"Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)~PredA + Kelac: At week 12, patients will be determined to be resolved, improving/stabilized or treatment failures. Patients who have complete resolution of edema will begin treatment withdrawal. Improving/stabilizing patients will maintain current therapy. Treatment failure Group 1 patients will be exited from the trial so that alternative therapy can be given."
144613|NCT01769352|O3|Outcome|Prednisolone Acetate Switched From Every 1 Hour to 4 Hours|Patients who switched from Prednisolone Acetate (PredA) 1% ophthalmic solution from every 1 hours while awake to every 4 hours at week 12.
144614|NCT01769352|O2|Outcome|Prednisolone Acetate Continued Every 1 Hour|Patients who continued on Prednisolone Acetate (PredA) 1% ophthalmic solution continued every 1 hour while awake at week 12.
144615|NCT01769352|O1|Outcome|Prednisolone Acetate Switched From 4 Hours to Every 1 Hour|Patients who switched from Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hours to every 1 hour while awake at week 12.
144616|NCT01769352|O3|Outcome|Prednisolone Acetate Switched From Every 1 Hour to 4 Hours|Patients who switched from Prednisolone Acetate (PredA) 1% ophthalmic solution from every 1 hours while awake to every 4 hours at week 12.
144617|NCT01769352|O2|Outcome|Prednisolone Acetate Continued Every 1 Hour|Patients who continued on Prednisolone Acetate (PredA) 1% ophthalmic solution continued every 1 hour while awake at week 12.
144618|NCT01769352|O1|Outcome|Prednisolone Acetate Switched From 4 Hours to Every 1 Hour|Patients who switched from Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hours to every 1 hour while awake at week 12.
144619|NCT01769352|O3|Outcome|Prednisolone Acetate Switched From Every 1 Hour to 4 Hours|Patients who switched from Prednisolone Acetate (PredA) 1% ophthalmic solution from every 1 hours while awake to every 4 hours at week 12.
144620|NCT01769352|O2|Outcome|Prednisolone Acetate Continued Every 1 Hour|Patients who continued on Prednisolone Acetate (PredA) 1% ophthalmic solution continued every 1 hour while awake at week 12.
144621|NCT01769352|O1|Outcome|Prednisolone Acetate Switched From 4 Hours to Every 1 Hour|Patients who switched from Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hours to every 1 hour while awake at week 12.
144622|NCT01769352|O4|Outcome|Post-Other Surgery Macular Edema- Group 2|Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hr (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
144809|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
144623|NCT01769352|O3|Outcome|Post-Other Surgery Macular Edema- Group 1|Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
144624|NCT01769352|O2|Outcome|Post-Cataract Surgery Macular Edema- Group 2|Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hr (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
144625|NCT01769352|O1|Outcome|Post-Cataract Surgery Macular Edema- Group 1|Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
144626|NCT01769352|O4|Outcome|Post-Other Surgery Macular Edema- Group 2|Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hr (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
144627|NCT01769352|O3|Outcome|Post-Other Surgery Macular Edema- Group 1|Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
144628|NCT01769352|O2|Outcome|Post-Cataract Surgery Macular Edema- Group 2|Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hr (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
144629|NCT01769352|O1|Outcome|Post-Cataract Surgery Macular Edema- Group 1|Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
144630|NCT01769352|O4|Outcome|Post-Other Surgery Macular Edema- Group 2|Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hr (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
144631|NCT01769352|O3|Outcome|Post-Other Surgery Macular Edema- Group 1|Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
144632|NCT01769352|O2|Outcome|Post-Cataract Surgery Macular Edema- Group 2|Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hr (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
144633|NCT01769352|O1|Outcome|Post-Cataract Surgery Macular Edema- Group 1|Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
144634|NCT01769352|E2|Reported Event|Prednisolone Acetate Four Times a Day (Group 2)|"Patients who were given Prednisolone Acetate (PredA) 1% ophthalmic solution four times a day~Adverse events are dose dependent and they don't depend on the type of surgery patient underwent previously. Therefore both, post-cataract surgery macular edema and post-other surgery macular edema adverse events were clumped together for patients who received PredA four times a day (qid) - Group 2."
144635|NCT01769352|E1|Reported Event|Prednisolone Acetate Every 1 Hour While Awake (Group 1)|"Patients who were given Prednisolone Acetate (PredA) 1% ophthalmic solution every 1 hour while awake.~Adverse events are dose dependent and they don't depend on the type of surgery patient underwent previously. Therefore both, post-cataract surgery macular edema and post-other surgery macular edema adverse events were clumped together for patients who received PredA every 1 hour (q1h) - Group 1."
144636|NCT01769339|B1|Baseline|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
144637|NCT01769339|P1|Participant Flow|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically (applied to skin) to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis (yeast infection of the vulva) were not cured clinically on Day 14.
144638|NCT01769339|O1|Outcome|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
144639|NCT01769339|O1|Outcome|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
144640|NCT01769339|O1|Outcome|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
144641|NCT01769339|O1|Outcome|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
144642|NCT01769339|E1|Reported Event|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
144643|NCT01769326|B5|Baseline|Total|Total of all reporting groups
144644|NCT01769326|B4|Baseline|Control Group for RAE|"Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.~Conventional Arm Exercise: Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises"
144645|NCT01769326|B3|Baseline|Resonating Arm Exerciser (RAE)|"Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program~Resonating Arm Exerciser: The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm."
144861|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
144646|NCT01769326|B2|Baseline|Control Group for Music Glove|"Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.~Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers"
144647|NCT01769326|B1|Baseline|MusicGlove Group|"Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program~MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips."
144648|NCT01769326|P4|Participant Flow|Control Group for RAE|"Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.~Conventional Arm Exercise: Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises"
144649|NCT01769326|P3|Participant Flow|Resonating Arm Exerciser (RAE)|"Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program~Resonating Arm Exerciser: The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm."
144650|NCT01769326|P2|Participant Flow|Control Group for Music Glove|"Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.~Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers"
144651|NCT01769326|P1|Participant Flow|MusicGlove Group|"Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program~MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips."
144652|NCT01769326|O2|Outcome|Control Group for RAE|"Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.~Conventional Arm Exercise: Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises"
144653|NCT01769326|O1|Outcome|Resonating Arm Exerciser (RAE)|"Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program~Resonating Arm Exerciser: The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm."
144654|NCT01769326|O2|Outcome|Control Group for Music Glove|"Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.~Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers"
144655|NCT01769326|O1|Outcome|MusicGlove Group|"Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program~MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips."
144656|NCT01769326|E4|Reported Event|Control Group for RAE|"Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.~Conventional Arm Exercise: Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises"
144657|NCT01769326|E3|Reported Event|Resonating Arm Exerciser (RAE)|"Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program~Resonating Arm Exerciser: The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm."
144658|NCT01769326|E2|Reported Event|Control Group for Music Glove|"Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.~Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers"
144659|NCT01769326|E1|Reported Event|MusicGlove Group|"Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program~MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips."
144660|NCT01769248|B3|Baseline|Total|Total of all reporting groups
144661|NCT01769248|B2|Baseline|Fine Needle Biopsy|"Fine needle biopsy~Fine needle biopsy: FNB"
144662|NCT01769248|B1|Baseline|Fine Needle Aspiration|"fine needle aspiration~Fine needle aspiration: Fine needle aspiration"
144663|NCT01769248|P2|Participant Flow|Fine Needle Biopsy (FNB)|"Fine Needle biopsy~Fine Needle biopsy: FNB, test arm for core biopsies, endoscopic ultrasound-FNB"
144664|NCT01769248|P1|Participant Flow|Fine Needle Aspiration (FNA)|"fine needle aspiration~Fine needle aspiration: Fine needle aspiration using endoscopic ultrasound-FNA needles. This was the standard of care arm"
144665|NCT01769248|O2|Outcome|Fine Needle Biopsy to Fine Needle Aspiration|"Fine needle biopsy to fine needle aspiration~EUS-FNB to EUS-FNA"
144666|NCT01769248|O1|Outcome|Fine Needle Aspiration to Fine Needle Biopsy|"fine needle aspiration to fine needle biopsy~EUS-FNA to EUS-FNB"
144667|NCT01769248|O2|Outcome|Fine Needle Biopsy|"Fine needle biopsy~Fine needle biopsy: FNB"
144668|NCT01769248|O1|Outcome|Fine Needle Aspiration|"fine needle aspiration~Fine needle aspiration: Fine needle aspiration"
144669|NCT01769248|O2|Outcome|Fine Needle Biopsy|"Fine needle biopsy~Fine needle biopsy: FNB"
144670|NCT01769248|O1|Outcome|Fine Needle Aspiration|"fine needle aspiration~Fine needle aspiration: Fine needle aspiration"
144671|NCT01769248|E2|Reported Event|Fine Needle Biopsy|"Fine needle biopsy~Fine needle biopsy: FNB"
144672|NCT01769248|E1|Reported Event|Fine Needle Aspiration|Fine needle aspiration: Fine needle aspiration
144673|NCT01769222|B3|Baseline|Total|Total of all reporting groups
144674|NCT01769222|B2|Baseline|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions~Ipilimumab: Given intratumorally~Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
144675|NCT01769222|B1|Baseline|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1~Ipilimumab: Given intratumorally"
164260|NCT01697501|O2|Outcome|"GT"|at IL28B genotype rs8099917
144676|NCT01769222|P2|Participant Flow|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions~Ipilimumab: Given intratumorally~Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
144677|NCT01769222|P1|Participant Flow|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1~Ipilimumab: Given intratumorally"
144678|NCT01769222|O2|Outcome|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions~Ipilimumab: Given intratumorally~Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
144679|NCT01769222|O1|Outcome|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1~Ipilimumab: Given intratumorally"
144680|NCT01769222|O2|Outcome|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions~Ipilimumab: Given intratumorally~Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
144681|NCT01769222|O1|Outcome|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1~Ipilimumab: Given intratumorally"
144682|NCT01769222|O2|Outcome|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions~Ipilimumab: Given intratumorally~Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
144683|NCT01769222|O1|Outcome|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1~Ipilimumab: Given intratumorally"
144684|NCT01769222|O2|Outcome|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions~Ipilimumab: Given intratumorally~Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
144685|NCT01769222|O1|Outcome|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1~Ipilimumab: Given intratumorally"
144686|NCT01769222|O2|Outcome|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions~Ipilimumab: Given intratumorally~Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
144687|NCT01769222|O1|Outcome|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1~Ipilimumab: Given intratumorally"
144688|NCT01769222|E2|Reported Event|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions~Ipilimumab: Given intratumorally~Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
144689|NCT01769222|E1|Reported Event|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1~Ipilimumab: Given intratumorally"
144690|NCT01769196|B3|Baseline|Total|Total of all reporting groups
144691|NCT01769196|B2|Baseline|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
144692|NCT01769196|B1|Baseline|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
144693|NCT01769196|P2|Participant Flow|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
144694|NCT01769196|P1|Participant Flow|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
144695|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
144696|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
144697|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
144698|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
144699|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
144700|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
144701|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
144702|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
144703|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
144704|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
144705|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
144706|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
144707|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
144708|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
144709|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
144710|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
144711|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
144712|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
144713|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
144714|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
144715|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
144716|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
144717|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
144718|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
144719|NCT01769196|E2|Reported Event|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
144720|NCT01769196|E1|Reported Event|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
144721|NCT01769105|B3|Baseline|Total|Total of all reporting groups
144722|NCT01769105|B2|Baseline|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
144723|NCT01769105|B1|Baseline|Standard Lid Hygiene Regime First, Then Lipiflow|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily, then Lipiflow~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily, then a single Lipiflow-treatment"
144724|NCT01769105|P2|Participant Flow|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
144725|NCT01769105|P1|Participant Flow|Standard Lid Hygiene Regime First, Then Lipiflow|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily, then Lipiflow~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily and after 3 month a single Lipiflow treatment"
144726|NCT01769105|O3|Outcome|Cross-over Lipiflow|Patients receive Lipiflow after performing Lid hygiene for 3 month
144727|NCT01769105|O2|Outcome|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
144728|NCT01769105|O1|Outcome|Standard Lid Hygiene Regime|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily"
144729|NCT01769105|O3|Outcome|Cross-over Lipiflow|Patients receive Lipiflow after performing Lid hygiene for 3 month
144730|NCT01769105|O2|Outcome|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
144731|NCT01769105|O1|Outcome|Standard Lid Hygiene Regime|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily"
144732|NCT01769105|O3|Outcome|Cross-over Lipiflow|Patients receive Lipiflow after performing Lid hygiene for 3 month
144733|NCT01769105|O2|Outcome|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
144734|NCT01769105|O1|Outcome|Standard Lid Hygiene Regime|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily"
144735|NCT01769105|O3|Outcome|Cross-over Lipiflow|Patients receive Lipiflow after performing Lid hygiene for 3 month
144736|NCT01769105|O2|Outcome|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
144737|NCT01769105|O1|Outcome|Standard Lid Hygiene Regime|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily"
144738|NCT01769105|O3|Outcome|Cross-over Lipiflow|patients received a single Lipiflow treatment after performing lid hygiene for 3 month
144739|NCT01769105|O2|Outcome|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
144740|NCT01769105|O1|Outcome|Standard Lid Hygiene Regime|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily"
144741|NCT01769105|E2|Reported Event|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
144742|NCT01769105|E1|Reported Event|Standard Lid Hygiene Regime First, Then Lipiflow|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily first and then Lipiflow~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily and after 3 month a single Lipiflow-treatment"
144743|NCT01768676|B3|Baseline|Total|Total of all reporting groups
144744|NCT01768676|B2|Baseline|Placebo|placebo taken once daily in the evening
144745|NCT01768676|B1|Baseline|Avanafil|100 mg once daily in the evening
144746|NCT01768676|P2|Participant Flow|Placebo|placebo taken once daily in the evening
144747|NCT01768676|P1|Participant Flow|Avanafil|100 mg once daily in the evening
144748|NCT01768676|O2|Outcome|Placebo|placebo taken once daily in the evening
144749|NCT01768676|O1|Outcome|Avanafil|100 mg once daily in the evening
144750|NCT01768676|O2|Outcome|Placebo|placebo taken once daily in the evening
144751|NCT01768676|O1|Outcome|Avanafil|100 mg once daily in the evening
144752|NCT01768676|O2|Outcome|Placebo|placebo taken once daily in the evening
144753|NCT01768676|O1|Outcome|Avanafil|100 mg once daily in the evening
144754|NCT01768676|O2|Outcome|Placebo|placebo taken once daily in the evening
144755|NCT01768676|O1|Outcome|Avanafil|100 mg once daily in the evening
144756|NCT01768676|O2|Outcome|Placebo|placebo taken once daily in the evening
144757|NCT01768676|O1|Outcome|Avanafil|100 mg once daily in the evening
144758|NCT01768676|E2|Reported Event|Placebo|placebo taken once daily in the evening
144759|NCT01768676|E1|Reported Event|Avanafil|100 mg once daily in the evening
144760|NCT01768572|B4|Baseline|Total|Total of all reporting groups
144761|NCT01768572|B3|Baseline|Tocilizumab q4w|Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Dose for tocilizumab could be up-titrated to 8 mg/kg or down-titrated to 4 mg/kg based on clinical response as per Investigator’s discretion.
144762|NCT01768572|B2|Baseline|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
144763|NCT01768572|B1|Baseline|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
144764|NCT01768572|P3|Participant Flow|Tocilizumab q4w|Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Dose for tocilizumab could be up-titrated to 8 mg/kg or down-titrated to 4 mg/kg based on clinical response as per Investigator’s discretion.
144765|NCT01768572|P2|Participant Flow|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
144766|NCT01768572|P1|Participant Flow|Sarilumab 150 mg q2w|Sarilumab 150 mg subcutaneous (SC) injection once every 2 weeks (q2w) and placebo intravenous (IV) infusion once every 4 weeks (q4w) was added to one or a combination of the nonbiologic disease modifying antirheumatic drug (DMARD) for 24 weeks.
144767|NCT01768572|O3|Outcome|Tocilizumab q4w|Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Dose for tocilizumab could be up-titrated to 8 mg/kg or down-titrated to 4 mg/kg based on clinical response as per Investigator’s discretion.
144768|NCT01768572|O2|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
144769|NCT01768572|O1|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
144770|NCT01768572|E3|Reported Event|Tocilizumab q4w|Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Dose for tocilizumab could be up-titrated to 8 mg/kg or down-titrated to 4 mg/kg based on clinical response as per Investigator’s discretion.
144771|NCT01768572|E2|Reported Event|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
144772|NCT01768572|E1|Reported Event|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
144773|NCT01768559|B4|Baseline|Total|Total of all reporting groups
144774|NCT01768559|B3|Baseline|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of insulin glargine with or without metformin.
144775|NCT01768559|B2|Baseline|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of insulin glargine with or without metformin.
144776|NCT01768559|B1|Baseline|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
144777|NCT01768559|P3|Participant Flow|Insulin Glulisine TID|Insulin glulisine thrice daily (TID) SC up to Week 26 on top of insulin glargine with or without metformin.
144778|NCT01768559|P2|Participant Flow|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of insulin glargine with or without metformin.
144779|NCT01768559|P1|Participant Flow|Lixisenatide|Lixisenatide 10 mcg once daily (QD) subcutaneously (SC) for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
144780|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of insulin glargine with or without metformin.
144781|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of insulin glargine with or without metformin.
144782|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
144783|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
144784|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
144785|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
144786|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
144787|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
144788|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
144789|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
144790|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
144791|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
144792|NCT01768559|O2|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
144793|NCT01768559|O1|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
144794|NCT01768559|O2|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
144795|NCT01768559|O1|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
144796|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
144797|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
144798|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
144799|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
144800|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
144801|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
144802|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
144803|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
144804|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
144805|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
144806|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
144807|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
144810|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
144811|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
144812|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
144813|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
144814|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
144815|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
144816|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
144817|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
144818|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
144819|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
144820|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
144821|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
144822|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
144823|NCT01768559|E3|Reported Event|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin (Median exposure of 182 days).
144824|NCT01768559|E2|Reported Event|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin (Median exposure of 182 days).
144825|NCT01768559|E1|Reported Event|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin (Median exposure of 182 days).
144826|NCT01768325|B3|Baseline|Total|Total of all reporting groups
144827|NCT01768325|B2|Baseline|ProCore Needle|
144828|NCT01768325|B1|Baseline|QuickCore Needle|
144829|NCT01768325|P2|Participant Flow|ProCore Needle|
144830|NCT01768325|P1|Participant Flow|Quick Core Needle|
144831|NCT01768325|O2|Outcome|ProCore Needle|
144832|NCT01768325|O1|Outcome|Quick Core Needle|
144833|NCT01768325|O2|Outcome|ProCore Needle|
144834|NCT01768325|O1|Outcome|Quick Core Needle|
144835|NCT01768325|O2|Outcome|ProCore Needle|"Core biopsy needle comparison to obtain diagnostic yield.~Cook Medical core biopsy needle: Obtaining a larger specimen."
144836|NCT01768325|O1|Outcome|Quick Core Needle|"Comparison of ProCore core biopsy needle to QuickCore core biopsy needle.Cook Medical core biopsy needle~Cook Medical core biopsy needle: Obtaining a larger specimen."
144837|NCT01768325|E2|Reported Event|ProCore Needle|
144838|NCT01768325|E1|Reported Event|Quick Core Needle|
144839|NCT01768286|B5|Baseline|Total|Total of all reporting groups
144840|NCT01768286|B4|Baseline|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
144841|NCT01768286|B3|Baseline|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
144842|NCT01768286|B2|Baseline|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
144843|NCT01768286|B1|Baseline|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
144844|NCT01768286|P4|Participant Flow|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
144845|NCT01768286|P3|Participant Flow|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
144846|NCT01768286|P2|Participant Flow|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks
144847|NCT01768286|P1|Participant Flow|LDV/SOF 12 Weeks|Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet once daily for 12 weeks
144848|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
144849|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
144850|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
144851|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
144852|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
144853|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
144854|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
144855|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
144856|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
144857|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
144858|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
144859|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
144860|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
164261|NCT01697501|O1|Outcome|"TT"|at IL28B genotype rs8099917
144862|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
144863|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
144864|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
144865|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
144866|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
144867|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
144868|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
144869|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
144870|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
144871|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
144872|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
144873|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
144874|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
144875|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
144876|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
144877|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
144878|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
144879|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
144880|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
144881|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
144882|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
144883|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
144884|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
144885|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
144886|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
144887|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
144888|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
144889|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
144890|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
144891|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
144892|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
144893|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
144894|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
144895|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
144896|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
144897|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
144898|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
144899|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
144900|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
144901|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
144902|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
144903|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
144904|NCT01768286|E4|Reported Event|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
144905|NCT01768286|E3|Reported Event|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
144906|NCT01768286|E2|Reported Event|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
144907|NCT01768286|E1|Reported Event|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
144908|NCT01768117|B1|Baseline|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
144909|NCT01768117|P1|Participant Flow|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
144910|NCT01768117|O1|Outcome|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
144911|NCT01768117|O1|Outcome|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
144912|NCT01768117|O1|Outcome|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
144913|NCT01768117|O1|Outcome|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
144916|NCT01768013|B1|Baseline|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144917|NCT01768013|P1|Participant Flow|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144918|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144919|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144920|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144921|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144922|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144923|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144924|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144925|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144926|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144927|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144928|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144929|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144930|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144931|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144932|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144980|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
164262|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs12979860
144933|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144934|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144935|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144936|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144937|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144938|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144939|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144940|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144941|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144942|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144943|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144944|NCT01768013|E1|Reported Event|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
144945|NCT01768000|B5|Baseline|Total|Total of all reporting groups
144946|NCT01768000|B4|Baseline|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
144947|NCT01768000|B3|Baseline|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
144948|NCT01768000|B2|Baseline|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualized intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
144981|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
144982|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
144983|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
144984|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
145765|NCT01765465|P2|Participant Flow|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months~Placebo"
144949|NCT01768000|B1|Baseline|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualized intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
144950|NCT01768000|P4|Participant Flow|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
144951|NCT01768000|P3|Participant Flow|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
144952|NCT01768000|P2|Participant Flow|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
144953|NCT01768000|P1|Participant Flow|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
144954|NCT01768000|O2|Outcome|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
144955|NCT01768000|O1|Outcome|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
144956|NCT01768000|O2|Outcome|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
144957|NCT01768000|O1|Outcome|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
144958|NCT01768000|O4|Outcome|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
144959|NCT01768000|O3|Outcome|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
144960|NCT01768000|O2|Outcome|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
144985|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
145766|NCT01765465|P1|Participant Flow|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months~Rowachol"
144961|NCT01768000|O1|Outcome|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
144962|NCT01768000|O4|Outcome|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
144963|NCT01768000|O3|Outcome|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
144964|NCT01768000|O2|Outcome|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
144965|NCT01768000|O1|Outcome|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
144966|NCT01768000|E4|Reported Event|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
144967|NCT01768000|E3|Reported Event|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
144968|NCT01768000|E2|Reported Event|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
144969|NCT01768000|E1|Reported Event|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
144970|NCT01767987|B3|Baseline|Total|Total of all reporting groups
144971|NCT01767987|B2|Baseline|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
144972|NCT01767987|B1|Baseline|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
144973|NCT01767987|P2|Participant Flow|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
144974|NCT01767987|P1|Participant Flow|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
144975|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
144976|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
144977|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
144978|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
144979|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
144986|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
144987|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
144988|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
144989|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
144990|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
144991|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
144992|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
144993|NCT01767987|E2|Reported Event|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
144994|NCT01767987|E1|Reported Event|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
144995|NCT01767935|B1|Baseline|Treatment (Cryosurgery and Radiation Therapy)|"Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~cryosurgery: Undergo cryosurgery~radiation therapy: Undergo radiation therapy~quality-of-life assessment: Ancillary studies"
144996|NCT01767935|P1|Participant Flow|Treatment (Cryosurgery and Radiation Therapy)|"Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~cryosurgery: Undergo cryosurgery~radiation therapy: Undergo radiation therapy~quality-of-life assessment: Ancillary studies"
144997|NCT01767935|O1|Outcome|Treatment (Cryosurgery and Radiation Therapy)|"Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~cryosurgery: Undergo cryosurgery~radiation therapy: Undergo radiation therapy~quality-of-life assessment: Ancillary studies"
144998|NCT01767935|O1|Outcome|Treatment (Cryosurgery and Radiation Therapy)|"Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~cryosurgery: Undergo cryosurgery~radiation therapy: Undergo radiation therapy~quality-of-life assessment: Ancillary studies"
144999|NCT01767935|O1|Outcome|Treatment (Cryosurgery and Radiation Therapy)|"Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~cryosurgery: Undergo cryosurgery~radiation therapy: Undergo radiation therapy~quality-of-life assessment: Ancillary studies"
145000|NCT01767935|O1|Outcome|Treatment (Cryosurgery and Radiation Therapy)|"Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~cryosurgery: Undergo cryosurgery~radiation therapy: Undergo radiation therapy~quality-of-life assessment: Ancillary studies"
145001|NCT01767935|O1|Outcome|Treatment (Cryosurgery and Radiation Therapy)|"Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~cryosurgery: Undergo cryosurgery~radiation therapy: Undergo radiation therapy~quality-of-life assessment: Ancillary studies"
145002|NCT01767935|E1|Reported Event|Treatment (Cryosurgery and Radiation Therapy)|"Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~cryosurgery: Undergo cryosurgery~radiation therapy: Undergo radiation therapy~quality-of-life assessment: Ancillary studies"
145003|NCT01767701|B1|Baseline|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.~Raltegravir: 400mg twice daily for 3 months"
145004|NCT01767701|P1|Participant Flow|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.~Raltegravir: 400mg twice daily for 3 months"
145005|NCT01767701|O1|Outcome|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.~Raltegravir: 400mg twice daily for 3 months"
145006|NCT01767701|O1|Outcome|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.~Raltegravir: 400mg twice daily for 3 months"
145007|NCT01767701|O1|Outcome|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.~Raltegravir: 400mg twice daily for 3 months"
145008|NCT01767701|O1|Outcome|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.~Raltegravir: 400mg twice daily for 3 months"
145009|NCT01767701|O1|Outcome|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily. The EDSS score is determined by the mean score over three months after treatment minus the mean score of the three months before treatment~Raltegravir: 400mg twice daily for 3 months"
145010|NCT01767701|O1|Outcome|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.~Raltegravir: 400mg twice daily for 3 months"
145011|NCT01767701|O1|Outcome|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.~Raltegravir: 400mg twice daily for 3 months"
145012|NCT01767701|O1|Outcome|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.~Raltegravir: 400mg twice daily for 3 months"
145013|NCT01767701|E1|Reported Event|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.~Raltegravir: 400mg twice daily for 3 months"
145014|NCT01767688|B3|Baseline|Total|Total of all reporting groups
145015|NCT01767688|B2|Baseline|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
145016|NCT01767688|B1|Baseline|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
145017|NCT01767688|P2|Participant Flow|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
145018|NCT01767688|P1|Participant Flow|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
145019|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
145020|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
145021|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
145022|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
145023|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
145024|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
145025|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
145026|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
145027|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
145028|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
145029|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
145030|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
145031|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
145032|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
145033|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
145034|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
145035|NCT01767688|E2|Reported Event|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
145036|NCT01767688|E1|Reported Event|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
145037|NCT01767597|B3|Baseline|Total|Total of all reporting groups
145038|NCT01767597|B2|Baseline|Rapid Testing|"HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).~Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day."
164263|NCT01697501|O4|Outcome|"TC+TT"|at IL28B genotype rs12979860
145039|NCT01767597|B1|Baseline|ELISA Testing|"HBV infection status determined by enzyme-linked immuno-assay (ELISA)~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days)."
145040|NCT01767597|P2|Participant Flow|Rapid Testing|"HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).~Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day."
145041|NCT01767597|P1|Participant Flow|ELISA Testing|"HBV infection status determined by enzyme-linked immuno-assay (ELISA)~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days)."
145042|NCT01767597|O2|Outcome|Rapid Testing|"HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).~Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day."
145043|NCT01767597|O1|Outcome|ELISA Testing|"HBV infection status determined by enzyme-linked immuno-assay (ELISA)~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days)."
145044|NCT01767597|E2|Reported Event|Rapid Testing|"HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).~Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day."
145045|NCT01767597|E1|Reported Event|ELISA Testing|"HBV infection status determined by enzyme-linked immuno-assay (ELISA)~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days)."
145046|NCT01767519|B4|Baseline|Total|Total of all reporting groups
145047|NCT01767519|B3|Baseline|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
145048|NCT01767519|B2|Baseline|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
145049|NCT01767519|B1|Baseline|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
145050|NCT01767519|P3|Participant Flow|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
145051|NCT01767519|P2|Participant Flow|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
145052|NCT01767519|P1|Participant Flow|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
145053|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
145054|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
145055|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
145056|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
145057|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
145058|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
145059|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
145060|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
145061|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
145062|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
145063|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
145064|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
145065|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
145066|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
145067|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
145068|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
145069|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
145070|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
145071|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
145072|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
145073|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
145074|NCT01767519|E3|Reported Event|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
145075|NCT01767519|E2|Reported Event|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
145076|NCT01767519|E1|Reported Event|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
145077|NCT01767506|B3|Baseline|Total|Total of all reporting groups
145078|NCT01767506|B2|Baseline|Usual Care|"Communities will receive usual care, including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more.~Usual care: Scheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more."
145079|NCT01767506|B1|Baseline|Intervention|"Communities will receive usual care,including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more. In addition, surveillance and treatment with azithromycin of newcomer and traveler families within 2 weeks of arrival to or return to the community.~Surveillance and treatment with azithromycin of newcomer and traveler families: The intervention is a surveillance for newcomers and travelers in communities, and provision of azithromycin to them at the time of arrival, in advance of scheduled mass drug administration~Usual care: Scheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-e"
145080|NCT01767506|P2|Participant Flow|Usual Care|"Communities will receive usual care, including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more.~Usual care: Scheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more."
145081|NCT01767506|P1|Participant Flow|Intervention|"Communities will receive usual care,including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or Follicular Trachoma (TF) is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more. In addition, surveillance and treatment with azithromycin of newcomer and traveler families within 2 weeks of arrival to or return to the community.~Surveillance and treatment with azithromycin of newcomer and traveler families: The intervention is a surveillance for newcomers and travelers in communities, and provision of azithromycin to them at the time of arrival, in advance of scheduled mass drug administration~Usual care: Scheduled MDA of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-e"
145082|NCT01767506|O2|Outcome|Usual Care|"Communities will receive usual care, including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more.~Usual care: Scheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more."
145083|NCT01767506|O1|Outcome|Intervention|"Communities will receive usual care,including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more. In addition, surveillance and treatment with azithromycin of newcomer and traveler families within 2 weeks of arrival to or return to the community.~Surveillance and treatment with azithromycin of newcomer and traveler families: The intervention is a surveillance for newcomers and travelers in communities, and provision of azithromycin to them at the time of arrival, in advance of scheduled mass drug administration~Usual care: Scheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-e"
145084|NCT01767506|O2|Outcome|Usual Care|"Communities will receive usual care, including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more.~Usual care: Scheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more."
145085|NCT01767506|O1|Outcome|Intervention|"Communities will receive usual care,including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more. In addition, surveillance and treatment with azithromycin of newcomer and traveler families within 2 weeks of arrival to or return to the community.~Surveillance and treatment with azithromycin of newcomer and traveler families: The intervention is a surveillance for newcomers and travelers in communities, and provision of azithromycin to them at the time of arrival, in advance of scheduled mass drug administration~Usual care: Scheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-e"
145086|NCT01767506|O2|Outcome|Usual Care|"Communities will receive usual care, including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more.~Usual care: Scheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more."
145087|NCT01767506|O1|Outcome|Intervention|"Communities will receive usual care,including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more. In addition, surveillance and treatment with azithromycin of newcomer and traveler families within 2 weeks of arrival to or return to the community.~Surveillance and treatment with azithromycin of newcomer and traveler families: The intervention is a surveillance for newcomers and travelers in communities, and provision of azithromycin to them at the time of arrival, in advance of scheduled mass drug administration~Usual care: Scheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-e"
145088|NCT01767506|E2|Reported Event|Usual Care|"Communities will receive usual care, including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more.~Usual care: Scheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more."
145089|NCT01767506|E1|Reported Event|Intervention|"Communities will receive usual care,including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more. In addition, surveillance and treatment with azithromycin of newcomer and traveler families within 2 weeks of arrival to or return to the community.~Surveillance and treatment with azithromycin of newcomer and traveler families: The intervention is a surveillance for newcomers and travelers in communities, and provision of azithromycin to them at the time of arrival, in advance of scheduled mass drug administration~Usual care: Scheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-e"
145090|NCT01767467|B3|Baseline|Total|Total of all reporting groups
145091|NCT01767467|B2|Baseline|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
145092|NCT01767467|B1|Baseline|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
145093|NCT01767467|P2|Participant Flow|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
145094|NCT01767467|P1|Participant Flow|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
164264|NCT01697501|O3|Outcome|"TT"|at IL28B genotype rs12979860
145095|NCT01767467|O4|Outcome|Placebo Non-HZ Cases Sub-Group|Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
145096|NCT01767467|O3|Outcome|Placebo HZ Cases Sub-Group|Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).
145097|NCT01767467|O2|Outcome|GSK1437173A Non-HZ Cases Sub-Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
145098|NCT01767467|O1|Outcome|GSK1437173A HZ Cases Sub-Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).
145099|NCT01767467|O4|Outcome|Placebo Non-HZ Cases Sub-Group|Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
145100|NCT01767467|O3|Outcome|Placebo HZ Cases Sub-Group|Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).
145101|NCT01767467|O2|Outcome|GSK1437173A Non-HZ Cases Sub-Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
145102|NCT01767467|O1|Outcome|GSK1437173A HZ Cases Sub-Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).
145103|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
145104|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
145105|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
145106|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
145107|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
145108|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
145109|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
145110|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
145111|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
145112|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
145113|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
145114|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
145115|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
145116|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
145117|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
145118|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
145119|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
145120|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
145121|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
145122|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
145123|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
145124|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
145125|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
145539|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145126|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
145127|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose)
145128|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose)
145129|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).
145130|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
145131|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).
145132|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
145133|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).
145134|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
145135|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).
145136|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
145137|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).
145138|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
145139|NCT01767467|E2|Reported Event|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
145140|NCT01767467|E1|Reported Event|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
145141|NCT01767376|B4|Baseline|Total|Total of all reporting groups
145142|NCT01767376|B3|Baseline|Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145143|NCT01767376|B2|Baseline|Nimenrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145144|NCT01767376|B1|Baseline|Nimenrix+ Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.
145145|NCT01767376|P3|Participant Flow|Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145146|NCT01767376|P2|Participant Flow|Nimenrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145147|NCT01767376|P1|Participant Flow|Nimenrix+ Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.
145148|NCT01767376|O3|Outcome|Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145149|NCT01767376|O2|Outcome|Nimenrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145150|NCT01767376|O1|Outcome|Nimenrix + Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.
145151|NCT01767376|O3|Outcome|Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145152|NCT01767376|O2|Outcome|Nimenrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145153|NCT01767376|O1|Outcome|Nimenrix + Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.
145227|NCT01767116|E2|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
145154|NCT01767376|O3|Outcome|Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145155|NCT01767376|O2|Outcome|Nimenrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145156|NCT01767376|O1|Outcome|Nimenrix + Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.
145157|NCT01767376|O3|Outcome|Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145158|NCT01767376|O2|Outcome|Nimenrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145159|NCT01767376|O1|Outcome|Nimenrix + Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.
145160|NCT01767376|O3|Outcome|Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145161|NCT01767376|O2|Outcome|Nimenrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145162|NCT01767376|O1|Outcome|Nimenrix + Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.
145163|NCT01767376|O3|Outcome|Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145164|NCT01767376|O2|Outcome|Nimenrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145165|NCT01767376|O1|Outcome|Nimenrix + Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.
145166|NCT01767376|O3|Outcome|Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145167|NCT01767376|O2|Outcome|Nimenrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145168|NCT01767376|O1|Outcome|Nimenri+ Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.
145169|NCT01767376|O3|Outcome|Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145170|NCT01767376|O2|Outcome|Nimenrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145171|NCT01767376|O1|Outcome|Nimenrix + Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.
145172|NCT01767376|O3|Outcome|Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145173|NCT01767376|O2|Outcome|Nimenrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145174|NCT01767376|O1|Outcome|Nimenrix + Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.
145175|NCT01767376|O3|Outcome|Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145176|NCT01767376|O2|Outcome|Nimenrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145177|NCT01767376|O1|Outcome|Nimenrix + Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.
145178|NCT01767376|O3|Outcome|Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145179|NCT01767376|O2|Outcome|Nimenrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145180|NCT01767376|O1|Outcome|Nimenrix + Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.
145181|NCT01767376|O2|Outcome|Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145182|NCT01767376|O1|Outcome|Nimenrix + Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.
145183|NCT01767376|O2|Outcome|Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145184|NCT01767376|O1|Outcome|Nimenrix + Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.
145185|NCT01767376|O3|Outcome|Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145186|NCT01767376|O2|Outcome|Nimenrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145187|NCT01767376|O1|Outcome|Nimenrix + Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.
145188|NCT01767376|E3|Reported Event|Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145189|NCT01767376|E2|Reported Event|Nimenrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
145190|NCT01767376|E1|Reported Event|Nimenrix+ Boostrix Group|Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.
145191|NCT01767285|B3|Baseline|Total|Total of all reporting groups
145192|NCT01767285|B2|Baseline|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
145193|NCT01767285|B1|Baseline|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
145194|NCT01767285|P2|Participant Flow|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
145195|NCT01767285|P1|Participant Flow|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
145196|NCT01767285|O2|Outcome|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
145197|NCT01767285|O1|Outcome|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
145198|NCT01767285|O2|Outcome|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
145199|NCT01767285|O1|Outcome|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
145200|NCT01767285|O2|Outcome|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
145201|NCT01767285|O1|Outcome|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
145202|NCT01767285|O2|Outcome|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
145203|NCT01767285|O1|Outcome|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
145204|NCT01767285|O2|Outcome|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
145205|NCT01767285|O1|Outcome|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
145206|NCT01767285|O2|Outcome|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
145207|NCT01767285|O1|Outcome|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
145208|NCT01767285|E2|Reported Event|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
145209|NCT01767285|E1|Reported Event|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
145210|NCT01767116|B3|Baseline|Total|Total of all reporting groups
145211|NCT01767116|B2|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
145212|NCT01767116|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
145213|NCT01767116|P2|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
145214|NCT01767116|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
145215|NCT01767116|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
145216|NCT01767116|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
145217|NCT01767116|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
145218|NCT01767116|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
145219|NCT01767116|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
145220|NCT01767116|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
145221|NCT01767116|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
145222|NCT01767116|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
145223|NCT01767116|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
145224|NCT01767116|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
145225|NCT01767116|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
145226|NCT01767116|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
145271|NCT01766921|B1|Baseline|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
145228|NCT01767116|E1|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
145229|NCT01767103|B4|Baseline|Total|Total of all reporting groups
145230|NCT01767103|B3|Baseline|Moderate Hepatic Failure|Moderate hepatic failure as defined by Child-Pugh Class B: 7-9 points
145231|NCT01767103|B2|Baseline|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
145232|NCT01767103|B1|Baseline|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
145233|NCT01767103|P3|Participant Flow|Moderate Hepatic Failure|Moderate hepatic impairment as defined by Child-Pugh Class : 7-9 points. All subjects received a single 33 mg/kg oral dose of deferiprone.
145234|NCT01767103|P2|Participant Flow|Mild Hepatic Failure|Mild hepatic impairment as defined by Child-Pugh Class C: 5-6 points. All subjects received a single 33 mg/kg oral dose of deferiprone.
145235|NCT01767103|P1|Participant Flow|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function. All subjects received a single 33 mg/kg oral dose of deferiprone.
145236|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
145237|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
145238|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
145239|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
145240|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
145241|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
145242|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
145243|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
145244|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
145245|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
145246|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
145247|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
145248|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by Child-Pugh Class B: 7-9 points
145249|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
145250|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
145251|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
145252|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
145253|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
145254|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
145255|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
145256|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
145257|NCT01767103|E3|Reported Event|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
145258|NCT01767103|E2|Reported Event|Mild Hepatic Failure|Mild hepatic failure as defined by the Child-Pugh Class C: 5-6 points
145259|NCT01767103|E1|Reported Event|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
145260|NCT01767064|B3|Baseline|Total|Total of all reporting groups
145261|NCT01767064|B2|Baseline|Control|Usual care with no posted letters.
145262|NCT01767064|B1|Baseline|Posted Commitment Letter|"The poster-sized (18x24 inches) commitment letter, written at the 8th grade reading-level and displayed in English and Spanish, emphasize clinician commitment to guidelines for appropriate antibiotic prescribing and explain why antibiotics are not appropriate in many cases. These letters, featuring clinician photographs and signatures, are displayed in clinician exam rooms for a 16-week period.~Posted commitment letter"
145263|NCT01767064|P2|Participant Flow|Control|Usual care with no posted letters.
145264|NCT01767064|P1|Participant Flow|Posted Commitment Letter|"The poster-sized (18x24 inches) commitment letter, written at the 8th grade reading-level and displayed in English and Spanish, emphasize clinician commitment to guidelines for appropriate antibiotic prescribing and explain why antibiotics are not appropriate in many cases. These letters, featuring clinician photographs and signatures, are displayed in clinician exam rooms for a 16-week period.~Posted commitment letter"
145265|NCT01767064|O2|Outcome|Control|Usual care with no posted letters.
145266|NCT01767064|O1|Outcome|Posted Commitment Letter|"The poster-sized (18x24 inches) commitment letter, written at the 8th grade reading-level and displayed in English and Spanish, emphasize clinician commitment to guidelines for appropriate antibiotic prescribing and explain why antibiotics are not appropriate in many cases. These letters, featuring clinician photographs and signatures, are displayed in clinician exam rooms for a 16-week period.~Posted commitment letter"
145267|NCT01767064|E2|Reported Event|Control|Usual care with no posted letters.
145268|NCT01767064|E1|Reported Event|Posted Commitment Letter|"The poster-sized (18x24 inches) commitment letter, written at the 8th grade reading-level and displayed in English and Spanish, emphasize clinician commitment to guidelines for appropriate antibiotic prescribing and explain why antibiotics are not appropriate in many cases. These letters, featuring clinician photographs and signatures, are displayed in clinician exam rooms for a 16-week period.~Posted commitment letter"
145269|NCT01766921|B3|Baseline|Total|Total of all reporting groups
145270|NCT01766921|B2|Baseline|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
164265|NCT01697501|O2|Outcome|"TC"|at IL28B genotype rs12979860
145272|NCT01766921|P2|Participant Flow|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
145273|NCT01766921|P1|Participant Flow|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
145274|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
145275|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
145276|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
145277|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
145278|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
145279|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
145280|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
145281|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
145282|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
145283|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
145284|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
145285|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
145286|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
145287|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
145288|NCT01766921|E3|Reported Event|Total|Total of subjects in both high and low dose groups.
145289|NCT01766921|E2|Reported Event|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 three weeks apart.
145290|NCT01766921|E1|Reported Event|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
145291|NCT01766778|B3|Baseline|Total|Total of all reporting groups
145292|NCT01766778|B2|Baseline|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
145293|NCT01766778|B1|Baseline|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
145294|NCT01766778|P2|Participant Flow|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
145295|NCT01766778|P1|Participant Flow|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
145296|NCT01766778|O2|Outcome|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
145297|NCT01766778|O1|Outcome|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
145298|NCT01766778|O2|Outcome|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
145299|NCT01766778|O1|Outcome|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
145300|NCT01766778|O2|Outcome|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
145301|NCT01766778|O1|Outcome|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
145302|NCT01766778|O2|Outcome|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
145303|NCT01766778|O1|Outcome|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
145304|NCT01766778|O2|Outcome|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
145305|NCT01766778|O1|Outcome|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
145306|NCT01766778|O2|Outcome|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
145307|NCT01766778|O1|Outcome|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
145308|NCT01766778|E2|Reported Event|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
145309|NCT01766778|E1|Reported Event|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
145310|NCT01766713|B3|Baseline|Total|Total of all reporting groups
145311|NCT01766713|B2|Baseline|Placebo|Placebo only
145312|NCT01766713|B1|Baseline|Ezetimibe|"10 mg/day of Ezetimibe~Ezetimibe"
145313|NCT01766713|P2|Participant Flow|Placebo|Placebo
145314|NCT01766713|P1|Participant Flow|Ezetimibe|"10 mg/day of Ezetimibe~Ezetimibe"
145315|NCT01766713|O2|Outcome|Placebo|Placebo
145316|NCT01766713|O1|Outcome|Ezetimibe|"10 mg/day of Ezetimibe~Ezetimibe"
145317|NCT01766713|E2|Reported Event|Placebo|
145320|NCT01766466|B2|Baseline|ITT Population - Ticagrelor 7 Doses|"On Day 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. Ticagrelor (180 mg) was administered at 0.5 h or 1.5 h after the initiation of cangrelor infusion. Patients were discharged and instructed to take 90 mg ticagrelor every 12 hours for 7 doses.~On Day 5: Cangrelor was administered after ticagrelor (90 mg)was discontinued 12 hours prior."
145321|NCT01766466|B1|Baseline|ITT Population - Ticagrelor 6 Doses|"On Day 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. Ticagrelor (180 mg) was administered at 0.5 h or 1.5 h after the initiation of cangrelor infusion. Patients were discharged and instructed to take 90 mg ticagrelor every 12 hours for 6 doses.~On Day 5: Cangrelor was administered after ticagrelor (90 mg)was discontinued 24 hours prior."
145322|NCT01766466|P4|Participant Flow|Day 5 - Ticagrelor (90mg) Dosing (7 Doses)|Ticagrelor (90mg) discontinued 12h prior to the initiation of a 2h cangrelor infusion.
145323|NCT01766466|P3|Participant Flow|Day 1 - Cangrelor + Ticagrelor (180mg) at 1.5h|Cangrelor IV (2h) + oral ticagrelor (180mg) administered at 1.5h after the initiation of the cangrelor infusion.
145324|NCT01766466|P2|Participant Flow|Day 5 - Ticagrelor (90 mg) Dosing (6 Doses)|Ticagrelor (90mg) discontinued 24h prior to the initiation of a 2h cangrelor infusion.
145325|NCT01766466|P1|Participant Flow|Day 1 - Cangrelor + Ticagrelor (180mg) at 0.5h|Cangrelor IV (2h) + oral ticagrelor (180mg) administered at 0.5h after the initiation of the cangrelor infusion.
145326|NCT01766466|O3|Outcome|Cangrelor + Ticagrelor 180mg at 0.5 h of Cangrelor Infusion|Cangrelor was administered as IV infusion for 2 hours.
145327|NCT01766466|O2|Outcome|Cangrelor + Ticagrelor 180mg at 1.25 h of Cangrelor Infusion|Cangrelor was administered as IV infusion for 2 hours.
145328|NCT01766466|O1|Outcome|All Patients|
145329|NCT01766466|O3|Outcome|Ticagrelor Discontinued 12 h Prior to Cangrelor Infusion|
145330|NCT01766466|O2|Outcome|Ticagrelor Discontinued 24 h Prior to Cangrelor Infusion|
145331|NCT01766466|O1|Outcome|All Patients|
145332|NCT01766466|O3|Outcome|Cangrelor + Ticagrelor 180mg at 0.5 h of Cangrelor Infusion|Cangrelor was administered as IV infusion for 2 hours.
145333|NCT01766466|O2|Outcome|Cangrelor + Ticagrelor 180mg at 1.25 h of Cangrelor Infusion|Cangrelor was administered as IV infusion for 2 hours.
145334|NCT01766466|O1|Outcome|All Patients|
145335|NCT01766466|E2|Reported Event|Cangrelor + Ticagrelor 90mg (7 Doses)|Ticagrelor discontinued 12 h prior to cangrelor infusion
145336|NCT01766466|E1|Reported Event|Cangrelor + Ticagrelor 90mg (6 Doses)|Ticagrelor was discontinued 24 h prior to cangrelor infusion
145337|NCT01766440|B1|Baseline|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days~Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
145338|NCT01766440|P1|Participant Flow|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days~Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
145339|NCT01766440|O1|Outcome|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days~Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
145340|NCT01766440|O1|Outcome|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days~Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
145341|NCT01766440|O1|Outcome|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days~Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
145342|NCT01766440|O1|Outcome|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days~Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
145343|NCT01766440|O1|Outcome|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days~Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
145344|NCT01766440|O1|Outcome|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days~Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
145345|NCT01766440|E1|Reported Event|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days~Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
145346|NCT01766336|B3|Baseline|Total|Total of all reporting groups
145347|NCT01766336|B2|Baseline|Placebo/ELND005|Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
145348|NCT01766336|B1|Baseline|ELND005/ELND005|Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251
145349|NCT01766336|P2|Participant Flow|Placebo/ELND005|Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
145350|NCT01766336|P1|Participant Flow|ELND005/ELND005|Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251
145351|NCT01766336|O2|Outcome|Placebo/ELND005|Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
145352|NCT01766336|O1|Outcome|ELND005/ELND005|Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251
145353|NCT01766336|E2|Reported Event|Placebo/ELND005|Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
145354|NCT01766336|E1|Reported Event|ELND005/ELND005|Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251
145355|NCT01766310|B3|Baseline|Total|Total of all reporting groups
145356|NCT01766310|B2|Baseline|Folic Acid|"Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study~Folic Acid"
145357|NCT01766310|B1|Baseline|Placebo|"placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study~placebo: sugar tablet manufactured to mimic folic acid tablet"
145358|NCT01766310|P2|Participant Flow|Folic Acid|"Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study~Folic Acid"
145359|NCT01766310|P1|Participant Flow|Placebo|"placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study~placebo: sugar tablet manufactured to mimic folic acid tablet"
145360|NCT01766310|O2|Outcome|Folic Acid|"Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study~Folic Acid"
145361|NCT01766310|O1|Outcome|Placebo|"placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study~placebo: sugar tablet manufactured to mimic folic acid tablet"
164266|NCT01697501|O1|Outcome|"CC"|at IL28B genotype rs12979860
145363|NCT01766310|O1|Outcome|Placebo|"placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study~placebo: sugar tablet manufactured to mimic folic acid tablet"
145364|NCT01766310|E2|Reported Event|Folic Acid|"Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study~Folic Acid"
145365|NCT01766310|E1|Reported Event|Placebo|"placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study~placebo: sugar tablet manufactured to mimic folic acid tablet"
145366|NCT01766102|B3|Baseline|Total|Total of all reporting groups
145367|NCT01766102|B2|Baseline|Standard Mammography|"Standard Specimen Mammography~Standard Mammography: There is not an added device associated with this arm."
145368|NCT01766102|B1|Baseline|Intra-operative Mammography|"Intra-operative Specimen Mammography~Intra-operative Mammography: The patient's breast specimen will be imagine in the operating room in an intra-operative imaging device - Biovision SN #30042"
145369|NCT01766102|P2|Participant Flow|Standard Mammography|"Standard Specimen Mammography~Standard Mammography: There is not an added device associated with this arm."
145370|NCT01766102|P1|Participant Flow|Intra-operative Mammography|"Intra-operative Specimen Mammography~Intra-operative Mammography: The patient's breast specimen will be imagine in the operating room in an intra-operative imaging device - Biovision SN #30042"
145371|NCT01766102|O2|Outcome|Standard Mammography|"Standard Specimen Mammography~Standard Mammography: There is not an added device associated with this arm."
145372|NCT01766102|O1|Outcome|Intra-operative Mammography|"Intra-operative Specimen Mammography~Intra-operative Mammography: The patient's breast specimen will be imagine in the operating room in an intra-operative imaging device - Biovision SN #30042"
145373|NCT01766102|O2|Outcome|Standard Mammography|"Standard Specimen Mammography~Standard Mammography: There is not an added device associated with this arm."
145374|NCT01766102|O1|Outcome|Intra-operative Mammography|"Intra-operative Specimen Mammography~Intra-operative Mammography: The patient's breast specimen will be imagine in the operating room in an intra-operative imaging device - Biovision SN #30042"
145375|NCT01766102|E2|Reported Event|Standard Mammography|"Standard Specimen Mammography~Standard Mammography: There is not an added device associated with this arm."
145376|NCT01766102|E1|Reported Event|Intra-operative Mammography|"Intra-operative Specimen Mammography~Intra-operative Mammography: The patient's breast specimen will be imagine in the operating room in an intra-operative imaging device - Biovision SN #30042"
145377|NCT01766076|B3|Baseline|Total|Total of all reporting groups
145378|NCT01766076|B2|Baseline|Placebo First, Then Atorvastatin|"Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC will be collected for immune activation assays using flowcytometry~Placebo: PBMC were collected for immune activation assays using flowcytometry"
145379|NCT01766076|B1|Baseline|Atorvastatin First, Then Placebo|"Intervention is atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.~PBMC will be collected for immune activation assays using flowcytometry~'atorvastatin, Lipitor®': PBMC were collected for immune activation assays using flowcytometry"
145380|NCT01766076|P2|Participant Flow|Placebo First, Then Atorvastatin|"Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC were collected for immune activation assays using flowcytometry~Placebo: PBMC were collected for immune activation assays using flowcytometry"
145381|NCT01766076|P1|Participant Flow|Atorvastatin First, Then Placebo|"Intervention is atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.~PBMC were collected for immune activation assays using flowcytometry~'atorvastatin, Lipitor®': PBMC collected for immune activation assays using flowcytometry"
145382|NCT01766076|O2|Outcome|Placebo|"Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC will be collected for immune activation assays using flowcytometry~Placebo: PBMC were collected for immune activation assays using flowcytometry"
145383|NCT01766076|O1|Outcome|Atorvastatin|"Intervention is be atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.~PBMC were collected for immune activation assays using flowcytometry~'atorvastatin, Lipitor®': PBMC were collected for immune activation assays using flowcytometry"
145384|NCT01766076|E2|Reported Event|Placebo First, Then Atorvastatin|"Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC wiere collected for immune activation assays using flowcytometry~Placebo: PBMC were collected for immune activation assays using flowcytometry"
145385|NCT01766076|E1|Reported Event|Atorvastatin First, Then Placebo|"Intervention is atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.~PBMC were collected for immune activation assays using flowcytometry~'atorvastatin, Lipitor®': PBMCwere collected for immune activation assays using flowcytometry"
145386|NCT01766050|B1|Baseline|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
145387|NCT01766050|P1|Participant Flow|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
145388|NCT01766050|O1|Outcome|Post Treatment|Days 12 through 46 (Day of Discharge from Study). No study drug was administered during this time.
145389|NCT01766050|O1|Outcome|Post Treatment|Days 12 through 46 (Day of Discharge from Study). No study drug was administered during this time.
145390|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145391|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145571|NCT01765972|P4|Participant Flow|Spectacle/ Test 2/ Test 1/ Test 3|Subjects received spectacle and then received Test 2 (etafilcon A with print) and then received Test 1 (etafilcon A with Laceron) and then received Test 3 (etafilcon A with print) .
145392|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
145393|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
145394|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145395|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145396|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
145397|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
145398|NCT01766050|O1|Outcome|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
145399|NCT01766050|O1|Outcome|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
145400|NCT01766050|O1|Outcome|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
145401|NCT01766050|O5|Outcome|All Participants|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
145402|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145403|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145404|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
145405|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
145406|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145407|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145408|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
145409|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
145410|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145411|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145412|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
145413|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
145605|NCT01765764|O2|Outcome|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
145414|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145415|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145416|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
145417|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
145418|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145419|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145420|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered on Day 4.
145421|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day1.
145422|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145423|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145424|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
145425|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
145426|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day11.
145427|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145428|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
145429|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Days 1.
145430|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145431|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145432|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
145433|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
145434|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145435|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145436|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
145437|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
164928|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
145438|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1, 4, 7 and 11.
145439|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145440|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
145441|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
145442|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145443|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145444|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
145445|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
145446|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145447|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145448|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
145449|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
145450|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145451|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145452|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
145453|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
145454|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145455|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145456|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
145457|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
145458|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145459|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145460|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
145461|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
164929|NCT01694108|O2|Outcome|Control Children|No intervention
145462|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145463|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145464|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
145465|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
145466|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145467|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145468|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
145469|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
145470|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145471|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145472|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
145473|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
145474|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145475|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145476|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
145477|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
145478|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145479|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145480|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
145481|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
145482|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145483|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145484|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Days 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
145485|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
164930|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
145486|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145487|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145488|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
145489|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
145490|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145491|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145492|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Days 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
145493|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
145494|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145495|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145496|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
145497|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
145498|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145499|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145500|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Days 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
145501|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
145502|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145503|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145504|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
145505|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
145506|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145507|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145508|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
145509|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
145510|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145511|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145512|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
145513|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
145514|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
145515|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
145516|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
145517|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
145518|NCT01766050|E1|Reported Event|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
145519|NCT01766037|B3|Baseline|Total|Total of all reporting groups
145520|NCT01766037|B2|Baseline|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145521|NCT01766037|B1|Baseline|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145522|NCT01766037|P2|Participant Flow|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145523|NCT01766037|P1|Participant Flow|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145524|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145525|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145526|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145527|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145528|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145529|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145530|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145531|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145532|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145533|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145534|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145535|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145536|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145537|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145538|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145540|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145541|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145542|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145543|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145544|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145545|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145546|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145547|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145548|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145549|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145550|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145551|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145552|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145553|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145554|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145555|NCT01766037|E2|Reported Event|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145556|NCT01766037|E1|Reported Event|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
145557|NCT01766024|B3|Baseline|Total|Total of all reporting groups
145558|NCT01766024|B2|Baseline|Rebif → BCD-033|"Volunteers in this group initially will receive a single sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg.~Interferon beta-1a: Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days."
145559|NCT01766024|B1|Baseline|BCD-033 → Rebif|"Volunteers in this group initially will receive a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the reference drug Rebif® (interferon beta-1a) at a dose of 44 µg.~Interferon beta-1a: Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days."
145560|NCT01766024|P2|Participant Flow|Rebif → BCD-033|"Volunteers in this group initially will receive a single sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg.~Interferon beta-1a: Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days."
145561|NCT01766024|P1|Participant Flow|BCD-033 → Rebif|"Volunteers in this group initially will receive a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the reference drug Rebif® (interferon beta-1a) at a dose of 44 µg.~Interferon beta-1a: Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days."
145562|NCT01766024|O2|Outcome|Rebif|the endpoint was assessed in all the volunteer who received Rebif
145563|NCT01766024|O1|Outcome|BCD-033|the endpoint was assessed in all the volunteer who received BCD-033
145564|NCT01766024|O2|Outcome|Rebif|the endpoint was assessed in all the volunteer who received Rebif (interferon beta-1a) a
145565|NCT01766024|O1|Outcome|BCD-033|the endpoint was assessed in all the volunteer who received BCD-033 (interferon beta-1a)
145566|NCT01766024|O2|Outcome|Rebif|the endpoint was assessed in all the volunteer who received Rebif
145567|NCT01766024|O1|Outcome|BCD-033|the endpoint was assessed in all the volunteer who received BCD-033
145568|NCT01766024|E2|Reported Event|Rebif|the endpoint was assessed in all the volunteer who received Rebif
145569|NCT01766024|E1|Reported Event|BCD-033|the endpoint was assessed in all the volunteer who received BCD-033
145570|NCT01765972|B1|Baseline|Overall|All subjects that were dispensed a study lens.
145572|NCT01765972|P3|Participant Flow|Test 3/ Test 1/ Test 2/ Spectacle|Subjects received Test 3 (etafilcon A with print) and then received Test 1 (etafilcon A with Laceron) and then received Test 2 (etafilcon A with print) and then received spectacle.
145573|NCT01765972|P2|Participant Flow|Test 2/ Test 3/ Spectacle/ Test 1|Subjects received Test 2 (etafilcon A with print) and then received Test 3 (etafilcon A with print) and then received spectacle and then received Test 1 (etafilcon A with Laceron).
145574|NCT01765972|P1|Participant Flow|Test 1/Spectacle/Test 2/ Test 3|Subjects received Test 1 (etafilcon A with Laceron) and then received spectacle and then received Test 2 (etafilcon A with print) and then received Test 3 (etafilcon A with print).
145575|NCT01765972|O4|Outcome|Spectacle|Subjects that wore spectacles in any of the 4 periods of this study.
145576|NCT01765972|O3|Outcome|Test 3 (Etafilcon A With Print)|Subjects that received Test 3 (etafilcon A with print) lens in any of the 4 periods of this study.
145577|NCT01765972|O2|Outcome|Test 2 (Etafilcon A With Lacreon With Print)|Subjects that received Test 2 (etafilcon A with Lacreon with print) lens in any of the 4 periods of this study.
145578|NCT01765972|O1|Outcome|Test 1 (Etafilcon A With Lacreon)|Subjects that received Test 1 (etafilcon A with Lacreon) lens in any of the 4 periods of this study.
145579|NCT01765972|E4|Reported Event|Test 3 (Etafilcon A With Print)|Subjects received Test 3 (etafilcon A with print) in any of the 4 periods of this study.
145580|NCT01765972|E3|Reported Event|Test 2 (Etafilcon A With Lacreon With Print)|Subjects received Test 2 (etafilcon A with Lacreon with print) in any of the 4 periods of this study.
145581|NCT01765972|E2|Reported Event|Test 1 (Etafilcon A With Lacreon)|Subjects received Test 1 (etafilcon A with Lacreon) in any of the 4 periods of this study.
145582|NCT01765972|E1|Reported Event|Spectacle|Subjects wore spectacles in any of the 4 periods of this study.
145583|NCT01765803|B1|Baseline|Mellaril (Thioridazine)|"A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study~Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment."
145584|NCT01765803|P1|Participant Flow|Mellaril (Thioridazine)|"A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study~Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment."
145585|NCT01765803|O1|Outcome|Mellaril (Thioridazine)|"A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study~Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment."
145586|NCT01765803|O1|Outcome|Mellaril (Thioridazine)|"A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study~Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment."
145587|NCT01765803|E1|Reported Event|Mellaril (Thioridazine)|"A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study~Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment."
145588|NCT01765764|B4|Baseline|Total|Total of all reporting groups
145589|NCT01765764|B3|Baseline|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
145590|NCT01765764|B2|Baseline|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
145591|NCT01765764|B1|Baseline|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
145592|NCT01765764|P3|Participant Flow|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
145593|NCT01765764|P2|Participant Flow|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
145594|NCT01765764|P1|Participant Flow|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
145595|NCT01765764|O3|Outcome|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
145596|NCT01765764|O2|Outcome|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
145597|NCT01765764|O1|Outcome|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
145598|NCT01765764|O3|Outcome|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
145599|NCT01765764|O2|Outcome|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
145600|NCT01765764|O1|Outcome|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
145601|NCT01765764|O3|Outcome|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
145602|NCT01765764|O2|Outcome|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
145603|NCT01765764|O1|Outcome|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
145604|NCT01765764|O3|Outcome|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
164931|NCT01694108|O2|Outcome|Control Children|No intervention
145606|NCT01765764|O1|Outcome|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
145607|NCT01765764|E3|Reported Event|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
145608|NCT01765764|E2|Reported Event|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
145609|NCT01765764|E1|Reported Event|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
145610|NCT01765751|B4|Baseline|Total|Total of all reporting groups
145611|NCT01765751|B3|Baseline|Manual Cervical Distraction High Force|Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145612|NCT01765751|B2|Baseline|Manual Cervical Distraction Medium Force|Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145613|NCT01765751|B1|Baseline|Manual Cervical Distraction Low Force|Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145614|NCT01765751|P3|Participant Flow|Manual Cervical Distraction High Force|Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145615|NCT01765751|P2|Participant Flow|Manual Cervical Distraction Medium Force|Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145616|NCT01765751|P1|Participant Flow|Manual Cervical Distraction Low Force|Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145617|NCT01765751|O3|Outcome|Manual Cervical Distraction High Force|Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145618|NCT01765751|O2|Outcome|Manual Cervical Distraction Medium Force|Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145619|NCT01765751|O1|Outcome|Manual Cervical Distraction Low Force|Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145620|NCT01765751|O3|Outcome|Manual Cervical Distraction High Force|Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145621|NCT01765751|O2|Outcome|Manual Cervical Distraction Medium Force|Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145622|NCT01765751|O1|Outcome|Manual Cervical Distraction Low Force|Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145623|NCT01765751|O3|Outcome|Manual Cervical Distraction High Force|Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145624|NCT01765751|O2|Outcome|Manual Cervical Distraction Medium Force|Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145625|NCT01765751|O1|Outcome|Manual Cervical Distraction Low Force|Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145626|NCT01765751|O3|Outcome|Manual Cervical Distraction High Force|Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145627|NCT01765751|O2|Outcome|Manual Cervical Distraction Medium Force|Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145767|NCT01765465|O2|Outcome|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1-day to 3-month~Placebo"
145628|NCT01765751|O1|Outcome|Manual Cervical Distraction Low Force|Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145629|NCT01765751|O3|Outcome|Manual Cervical Distraction High Force|Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145630|NCT01765751|O2|Outcome|Manual Cervical Distraction Medium Force|Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145631|NCT01765751|O1|Outcome|Manual Cervical Distraction Low Force|Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145632|NCT01765751|O3|Outcome|MCD High Force|Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145633|NCT01765751|O2|Outcome|MCD Medium Force|Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145634|NCT01765751|O1|Outcome|MCD Low Force|Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145635|NCT01765751|O3|Outcome|Manual Cervical Distraction High Force|Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145636|NCT01765751|O2|Outcome|Manual Cervical Distraction Medium Force|Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145637|NCT01765751|O1|Outcome|Manual Cervical Distraction Low Force|Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145638|NCT01765751|O3|Outcome|Manual Cervical Distraction High Force|Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145639|NCT01765751|O2|Outcome|Manual Cervical Distraction Medium Force|Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145640|NCT01765751|O1|Outcome|Manual Cervical Distraction Low Force|Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145641|NCT01765751|O3|Outcome|MCD High Force|Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145642|NCT01765751|O2|Outcome|MCD Medium Force|Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145643|NCT01765751|O1|Outcome|MCD Low Force|Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145644|NCT01765751|E3|Reported Event|Manual Cervical Distraction High Force*|Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145645|NCT01765751|E2|Reported Event|Manual Cervical Distraction Medium Force*|Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145646|NCT01765751|E1|Reported Event|Manual Cervical Distraction Low Force|Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
145726|NCT01765569|E3|Reported Event|Period C|Single oral dose of digoxin 0.25 mg on Day 29, and vemurafenib 960 mg orally BID from Day 29 to Day 35.
145727|NCT01765569|E2|Reported Event|Period B|Vemurafenib 960 mg orally BID from Day 8 to Day 28.
145728|NCT01765569|E1|Reported Event|Period A|Single oral dose of digoxin 0.25 mg tablet on Day 1.
145647|NCT01765673|B1|Baseline|Vibrotactile Stimulation in Dysphagia|"A Vibrotactile stimulation device will be evaluated in patients with chronic moderate to severe dysphagia for more than 6 months post onset due to stroke or following radiation treatment for head and neck cancer to assess which frequency, mode, pressure characteristics are most helpful in increasing the rate of swallowing, increasing the urge to swallow, assisting with the initiation of swallowing and not affecting discomfort~Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions."
145648|NCT01765673|P1|Participant Flow|Vibrotactile Stimulation in Dysphagia|"A Vibrotactile stimulation device will be evaluated in patients with chronic moderate to severe dysphagia for more than 6 months post onset due to stroke or following radiation treatment for head and neck cancer to assess which frequency, mode, pressure characteristics are most helpful in increasing the rate of swallowing, increasing the urge to swallow, assisting with the initiation of swallowing and not affecting discomfort~Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions."
145649|NCT01765673|O1|Outcome|Vibrotactile Stimulation in Dysphagia|Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow and discomfort. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and swallow initiation time during vibration with no vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
145650|NCT01765673|O1|Outcome|Vibrotactile Stimulation in Dysphagia|Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow and discomfort. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
145651|NCT01765673|O1|Outcome|Vibrotactile Stimulation in Dysphagia|Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow and discomfort. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
145652|NCT01765673|O1|Outcome|Vibrotactile Stimulation in Dysphagia|Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow and discomfort. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
145653|NCT01765673|O1|Outcome|Vibrotactile Stimulation in Dysphagia|Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow and discomfort. Will also compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of swallow initiation. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
145654|NCT01765673|O1|Outcome|Vibrotactile Stimulation in Dysphagia|Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow and discomfort. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
145655|NCT01765673|O1|Outcome|Vibrotactile Stimulation in Dysphagia|Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow and discomfort. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
145656|NCT01765673|O1|Outcome|Vibrotactile Stimulation in Dysphagia|Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow and discomfort. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
145657|NCT01765673|O1|Outcome|Vibrotactile Stimulation in Dysphagia|Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow and discomfort. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
145658|NCT01765673|O1|Outcome|Vibrotactile Stimulation in Dysphagia|Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow and discomfort. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
145758|NCT01765530|O2|Outcome|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
145759|NCT01765530|O1|Outcome|ETT Cleaning Manuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
145659|NCT01765673|O1|Outcome|Vibrotactile Stimulation in Dysphagia|Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
145660|NCT01765673|O1|Outcome|Vibrotactile Stimulation in Dysphagia|Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
145661|NCT01765673|O1|Outcome|Vibrotactile Stimulation in Dysphagia|Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
145662|NCT01765673|O1|Outcome|Vibrotactile Stimulation in Dysphagia|Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
145663|NCT01765673|O1|Outcome|Vibrotactile Stimulation in Dysphagia|Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
145664|NCT01765673|O1|Outcome|Vibrotactile Stimulation in Dysphagia|Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
145665|NCT01765673|O1|Outcome|Vibrotactile Stimulation in Dysphagia|Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
145666|NCT01765673|O1|Outcome|Vibrotactile Stimulation in Dysphagia|Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
145667|NCT01765673|O1|Outcome|Vibrotactile Stimulation in Dysphagia|Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
145668|NCT01765673|O1|Outcome|Vibrotactile Stimulation in Dysphagia|Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
145669|NCT01765673|E1|Reported Event|Vibrotactile Stimulation in Dysphagia|Vibrotactile stimulation: Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
145670|NCT01765582|B4|Baseline|Total|Total of all reporting groups
145671|NCT01765582|B3|Baseline|Arm C: FOLFOX + Bevacizumab|Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145672|NCT01765582|B2|Baseline|Arm B: Sequential FOLFOXIRI + Bevacizumab|Participants received alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145760|NCT01765530|E2|Reported Event|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
145761|NCT01765530|E1|Reported Event|ETT Cleaning Manuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
145673|NCT01765582|B1|Baseline|Arm A: Concurrent FOLFOXIRI + Bevacizumab|Participants received concurrent FOLFOXIRI along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4 month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-fluorouracil (5-FU) with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145674|NCT01765582|P3|Participant Flow|Arm C: FOLFOX + Bevacizumab|Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145675|NCT01765582|P2|Participant Flow|Arm B: Sequential FOLFOXIRI + Bevacizumab|Participants received alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145676|NCT01765582|P1|Participant Flow|Arm A: Concurrent FOLFOXIRI + Bevacizumab|Participants received concurrent FOLFOXIRI along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4 month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-fluorouracil (5-FU) with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145677|NCT01765582|O4|Outcome|Arms A + B: Pooled FOLFOXIRI + Bevacizumab|This analysis set combines Arms A and B and represents participants who received either concurrent or sequential FOLFOXIRI with 5 mg/kg of bevacizumab during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145678|NCT01765582|O3|Outcome|Arm C: FOLFOX + Bevacizumab|Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145679|NCT01765582|O2|Outcome|Arm B: Sequential FOLFOXIRI + Bevacizumab|Participants received alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145680|NCT01765582|O1|Outcome|Arm A: Concurrent FOLFOXIRI + Bevacizumab|Participants received concurrent FOLFOXIRI along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4 month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-fluorouracil (5-FU) with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145681|NCT01765582|O4|Outcome|Arms A + B: Pooled FOLFOXIRI + Bevacizumab|This analysis set combines Arms A and B and represents participants who received either concurrent or sequential FOLFOXIRI with 5 mg/kg of bevacizumab during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145682|NCT01765582|O3|Outcome|Arm C: FOLFOX + Bevacizumab|Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145729|NCT01765543|B1|Baseline|Vemurafenib + Rifampin (All Periods)|There were 3 intervention periods in the study: Period A (Days 1 to 7), Period B (Days 8 to 16), and Period C (Days 17 to 24). Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally alone on Day 1 (Period A); with rifampin (at a dose of 600 mg as capsules orally) on Day 17 (Period C); and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 8 through 16 (Period B) and from Days 18 through 23 (Period C).
145683|NCT01765582|O2|Outcome|Arm B: Sequential FOLFOXIRI + Bevacizumab|Participants received alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145684|NCT01765582|O1|Outcome|Arm A: Concurrent FOLFOXIRI + Bevacizumab|Participants received concurrent FOLFOXIRI along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4 month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-fluorouracil (5-FU) with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145685|NCT01765582|O4|Outcome|Arms A + B: Pooled FOLFOXIRI + Bevacizumab|This analysis set combines Arms A and B and represents participants who received either concurrent or sequential FOLFOXIRI with 5 mg/kg of bevacizumab during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145686|NCT01765582|O3|Outcome|Arm C: FOLFOX + Bevacizumab|Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145687|NCT01765582|O2|Outcome|Arm B: Sequential FOLFOXIRI + Bevacizumab|Participants received alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145688|NCT01765582|O1|Outcome|Arm A: Concurrent FOLFOXIRI + Bevacizumab|Participants received concurrent FOLFOXIRI along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4 month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-fluorouracil (5-FU) with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145689|NCT01765582|O4|Outcome|Arms A + B: Pooled FOLFOXIRI + Bevacizumab|This analysis set combines Arms A and B and represents participants who received either concurrent or sequential FOLFOXIRI with 5 mg/kg of bevacizumab during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145690|NCT01765582|O3|Outcome|Arm C: FOLFOX + Bevacizumab|Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145691|NCT01765582|O2|Outcome|Arm B: Sequential FOLFOXIRI + Bevacizumab|Participants received alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145692|NCT01765582|O1|Outcome|Arm A: Concurrent FOLFOXIRI + Bevacizumab|Participants received concurrent FOLFOXIRI along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4 month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-fluorouracil (5-FU) with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145754|NCT01765530|P2|Participant Flow|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
145755|NCT01765530|P1|Participant Flow|ETT Cleaning Manuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
145693|NCT01765582|O4|Outcome|Arms A + B: Pooled FOLFOXIRI + Bevacizumab|This analysis set combines Arms A and B and represents participants who received either concurrent or sequential FOLFOXIRI with 5 mg/kg of bevacizumab during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145694|NCT01765582|O3|Outcome|Arm C: FOLFOX + Bevacizumab|Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145695|NCT01765582|O2|Outcome|Arm B: Sequential FOLFOXIRI + Bevacizumab|Participants received alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145696|NCT01765582|O1|Outcome|Arm A: Concurrent FOLFOXIRI + Bevacizumab|Participants received concurrent FOLFOXIRI along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4 month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-fluorouracil (5-FU) with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145697|NCT01765582|O4|Outcome|Arms A + B: Pooled FOLFOXIRI + Bevacizumab|This analysis set combines Arms A and B and represents participants who received either concurrent or sequential FOLFOXIRI with 5 mg/kg of bevacizumab during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145698|NCT01765582|O3|Outcome|Arm C: FOLFOX + Bevacizumab|Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145699|NCT01765582|O2|Outcome|Arm B: Sequential FOLFOXIRI + Bevacizumab|Participants received alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145700|NCT01765582|O1|Outcome|Arm A: Concurrent FOLFOXIRI + Bevacizumab|Participants received concurrent FOLFOXIRI along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4 month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-fluorouracil (5-FU) with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145701|NCT01765582|O4|Outcome|Arms A + B: Pooled FOLFOXIRI + Bevacizumab|This analysis set combines Arms A and B and represents participants who received either concurrent or sequential FOLFOXIRI with 5 mg/kg of bevacizumab during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145702|NCT01765582|O3|Outcome|Arm C: FOLFOX + Bevacizumab|Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145756|NCT01765530|O2|Outcome|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
145757|NCT01765530|O1|Outcome|ETT Cleaning Manuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
145762|NCT01765465|B3|Baseline|Total|Total of all reporting groups
145703|NCT01765582|O2|Outcome|Arm B: Sequential FOLFOXIRI + Bevacizumab|Participants received alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145704|NCT01765582|O1|Outcome|Arm A: Concurrent FOLFOXIRI + Bevacizumab|Participants received concurrent FOLFOXIRI along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4 month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-fluorouracil (5-FU) with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145705|NCT01765582|E3|Reported Event|Arm C: FOLFOX + Bevacizumab|Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145706|NCT01765582|E2|Reported Event|Arm B: Sequential FOLFOXIRI + Bevacizumab|Participants received alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145707|NCT01765582|E1|Reported Event|Arm A: Concurrent FOLFOXIRI + Bevacizumab|Participants received concurrent FOLFOXIRI along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4 month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-fluorouracil (5-FU) with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
145708|NCT01765569|B1|Baseline|Vemurafenib + Digoxin|"Single oral dose of digoxin 0.25 mg tablet on Day 1 in Period A, followed by vemurafenib 960 mg orally BID from Day 8 to Day 28 in Period B, and then single oral dose of digoxin 0.25 mg on Day 29, and vemurafenib 960 mg orally BID from Day 29 to Day 35 in Period C.~Digoxin: Participants received single oral dose of digoxin 0.25 mg tablet on Day 1 and Day 29.~Vemurafenib: Participants received vemurafenib 960 mg tablet orally BID from Day 8 to Day 35."
145709|NCT01765569|P1|Participant Flow|Vemurafenib + Digoxin|"Single oral dose of digoxin 0.25 mg tablet on Day 1 in Period A, followed by vemurafenib 960 mg orally BID from Day 8 to Day 28 in Period B, and then single oral dose of digoxin 0.25 mg on Day 29, and vemurafenib 960 mg orally BID from Day 29 to Day 35 in Period C.~Digoxin: Participants received single oral dose of digoxin 0.25 mg tablet on Day 1 and Day 29.~Vemurafenib: Participants received vemurafenib 960 mg tablet orally BID from Day 8 to Day 35."
145710|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
145711|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
145712|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
145713|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
145714|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
145715|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
145716|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
145717|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
145718|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
145719|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
145720|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
145721|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
145722|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
145723|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
145724|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
145725|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
145992|NCT01764997|B6|Baseline|Total|Total of all reporting groups
145730|NCT01765543|P1|Participant Flow|Vemurafenib + Rifampin (All Periods)|There were 3 intervention periods in the study: Period A (Days 1 to 7), Period B (Days 8 to 16), and Period C (Days 17 to 24). Participants, after an overnight fast of at least 10 hours, received vemurafenib (Zelboraf) at a dose of 960 milligrams (mg) as film-coated tablets orally alone on Day 1 (Period A); with rifampin (at a dose of 600 mg as capsules orally) on Day 17 (Period C); and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 8 through 16 (Period B) and from Days 18 through 23 (Period C).
145731|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
145732|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
145733|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
145734|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
145735|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
145736|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
145737|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
145738|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
145739|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
145740|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
145741|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
145742|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
145743|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
145744|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
145745|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
145746|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
145747|NCT01765543|E4|Reported Event|Vemurafenib + Rifampin (All Periods)|There were 3 intervention periods in the study: Period A (Days 1 to 7), Period B (Days 8 to 16), and Period C (Days 17 to 24). Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally alone on Day 1 (Period A); with rifampin (at a dose of 600 mg as capsules orally) on Day 17 (Period C); and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 8 through 16 (Period B) and from Days 18 through 23 (Period C).
145748|NCT01765543|E3|Reported Event|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
145749|NCT01765543|E2|Reported Event|Rifampin (Intervention Period B)|Participants received rifampin alone at a dose of 600 mg as capsules orally once daily from Days 8 through 16.
145750|NCT01765543|E1|Reported Event|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
145751|NCT01765530|B3|Baseline|Total|Total of all reporting groups
145752|NCT01765530|B2|Baseline|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
145753|NCT01765530|B1|Baseline|ETT Cleaning Manuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
145768|NCT01765465|O1|Outcome|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1-day to 3-month~Rowachol"
145769|NCT01765465|O2|Outcome|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1-day to 3-month~Placebo"
145770|NCT01765465|O1|Outcome|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1-day to 3-month~Rowachol"
145771|NCT01765465|O2|Outcome|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1-day to 3-month~Placebo"
145772|NCT01765465|O1|Outcome|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1-day to 3-month~Rowachol"
145773|NCT01765465|O2|Outcome|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months~Placebo"
145774|NCT01765465|O1|Outcome|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months~Rowachol"
145775|NCT01765465|E2|Reported Event|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months~Placebo"
145776|NCT01765465|E1|Reported Event|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months~Rowachol"
145777|NCT01765426|B5|Baseline|Total|Total of all reporting groups
145778|NCT01765426|B4|Baseline|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145779|NCT01765426|B3|Baseline|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
145780|NCT01765426|B2|Baseline|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145781|NCT01765426|B1|Baseline|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145782|NCT01765426|P4|Participant Flow|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145783|NCT01765426|P3|Participant Flow|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
145784|NCT01765426|P2|Participant Flow|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145785|NCT01765426|P1|Participant Flow|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145786|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145787|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
145788|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145789|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145790|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145791|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
145792|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145793|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145794|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145795|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
145796|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145797|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145798|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145799|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
145800|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145801|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145802|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145803|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
145804|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145805|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145806|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145807|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
145808|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145809|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145810|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145811|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
145812|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145813|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145814|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145815|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
145816|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145817|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145818|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145819|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
145820|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145821|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
147599|NCT01760889|P3|Participant Flow|Placebo|Placebo: One capsule a day for 26 weeks
145822|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145823|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
145824|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145825|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145826|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145827|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
145828|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145829|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145830|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145831|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
145832|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145833|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145834|NCT01765426|E4|Reported Event|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145835|NCT01765426|E3|Reported Event|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
145836|NCT01765426|E2|Reported Event|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145837|NCT01765426|E1|Reported Event|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
145838|NCT01765270|B3|Baseline|Total|Total of all reporting groups
145839|NCT01765270|B2|Baseline|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
145840|NCT01765270|B1|Baseline|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
145841|NCT01765270|P2|Participant Flow|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before coronary artery bypass graft (CABG) surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
145842|NCT01765270|P1|Participant Flow|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before coronary artery bypass graft (CABG) surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
145843|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
145844|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
145845|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
145846|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.daily
151886|NCT01739335|O1|Outcome|Mifepristone (600 mg/Day)|600 mg/day mifepristone for one week
145847|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
145848|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
145849|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
145850|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
145851|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
145852|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
145853|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
145854|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
145855|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
145856|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
145857|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
145858|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
145859|NCT01765270|E2|Reported Event|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
145860|NCT01765270|E1|Reported Event|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
145861|NCT01765192|B3|Baseline|Total|Total of all reporting groups
145862|NCT01765192|B2|Baseline|Placebo Plus Montelukast, Then Roflumilast Plus Montelukast|Participants in sequence 2 received placebo plus montelukast 10 mg orally once daily for 4 weeks followed by a 4-week washout period and then received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
145863|NCT01765192|B1|Baseline|Roflumilast Plus Montelukast, Then Placebo Plus Montelukast|Participants in sequence 1 received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks followed by a 4-week washout period and then received placebo plus montelukast 10 mg orally once daily for 4 weeks.
145864|NCT01765192|P2|Participant Flow|Placebo Plus Montelukast, Then Roflumilast Plus Montelukast|Participants in sequence 2 received placebo plus montelukast 10 mg orally once daily for 4 weeks followed by a 4-week washout period and then received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
145865|NCT01765192|P1|Participant Flow|Roflumilast Plus Montelukast, Then Placebo Plus Montelukast|Participants in sequence 1 received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks followed by a 4-week washout period and then received placebo plus montelukast 10 mg orally once daily for 4 weeks.
145866|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
145867|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
145868|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
145869|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
145870|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
145871|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
145872|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
145873|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
145874|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
145875|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
145876|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
145877|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
145878|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
145879|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
145880|NCT01765192|E2|Reported Event|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
145881|NCT01765192|E1|Reported Event|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
145882|NCT01765179|B1|Baseline|Oral Testosterone Undecanoate|Oral testosterone undecanoate: Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.
145883|NCT01765179|P1|Participant Flow|Oral Testosterone Undecanoate|Oral testosterone undecanoate: Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.
145884|NCT01765179|O1|Outcome|Oral Testosterone Undecanoate|Oral testosterone undecanoate: Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.
145885|NCT01765179|O1|Outcome|Oral Testosterone Undecanoate|Oral testosterone undecanoate: Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.
145886|NCT01765179|E1|Reported Event|Oral Testosterone Undecanoate|Oral testosterone undecanoate: Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.
145887|NCT01765153|B3|Baseline|Total|Total of all reporting groups
145888|NCT01765153|B2|Baseline|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training was 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145889|NCT01765153|B1|Baseline|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for training in the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145890|NCT01765153|P2|Participant Flow|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training, which is followed by another 2-month rest.
145891|NCT01765153|P1|Participant Flow|Endurance First|Participants start with Endurance Training. Participants trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for Precision Training 5x/wk for 2 months. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145892|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145893|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145894|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145895|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145993|NCT01764997|B5|Baseline|Sarilumab 150 mg + MTX Open Label Sub-study|Sarilumab 150 mg SC injection Q2W for 52 weeks added to stable dose of MTX.
145994|NCT01764997|B4|Baseline|Sarilumab 200 mg + MTX (Randomized)|Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
145896|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145897|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145898|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145899|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145900|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
145901|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145902|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145903|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145904|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
145905|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145906|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight can be used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
145907|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for training in the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145908|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145909|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145910|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145911|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145912|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145913|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145914|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145915|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145916|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145917|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145918|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145919|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
151887|NCT01739335|O2|Outcome|Sugar Pill|Placebo (sugar pill) for one week
145920|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145921|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145922|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145923|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145924|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145925|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145926|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145927|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145928|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145929|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145930|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145931|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
164932|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
145932|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145933|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145934|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145935|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145936|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145937|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145938|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145939|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145940|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145941|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145942|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145943|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
164933|NCT01694108|O2|Outcome|Control Children|No intervention
145944|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145945|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145946|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145947|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145948|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145949|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145950|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145951|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145952|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145953|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145954|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145955|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
164934|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
145956|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145957|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145958|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145959|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145960|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145961|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145962|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145963|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145964|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145965|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145966|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145967|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
164935|NCT01694108|O2|Outcome|Control Children|No intervention
145968|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
145969|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145970|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145971|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145972|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145973|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145974|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145975|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145976|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
145977|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145978|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
145979|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145980|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
145981|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145982|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
145983|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145984|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
145985|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for training in the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145986|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145987|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Trainingis 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for training in the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145988|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145989|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145990|NCT01765153|E2|Reported Event|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
145991|NCT01765153|E1|Reported Event|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
145995|NCT01764997|B3|Baseline|Sarilumab 150 mg + MTX (Randomized)|Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
145996|NCT01764997|B2|Baseline|Etanercept + MTX (Randomized)|Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX.
145997|NCT01764997|B1|Baseline|Adalimumab Open Label run-in Treatment Only|Adalimumab 40 mg SC injection Q2W for 16 weeks added to stable dose of MTX during run-in period. Participants who were not randomized in the main study or did not enter the sub-study were included in this arm for safety assessment.
145998|NCT01764997|P5|Participant Flow|Sarilumab 150 mg + MTX Open Label Sub-study|Sarilumab 150 mg SC injection Q2W for 52 weeks added to stable dose of MTX.
145999|NCT01764997|P4|Participant Flow|Sarilumab 200 mg + MTX (Randomized)|Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
146000|NCT01764997|P3|Participant Flow|Sarilumab 150 mg + MTX (Randomized)|Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
146001|NCT01764997|P2|Participant Flow|Etanercept + MTX (Randomized)|Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX.
146002|NCT01764997|P1|Participant Flow|Adalimumab Open Label run-in|Adalimumab 40 mg subcutaneous (SC) injection every 2 weeks (Q2W) for 16 weeks added to stable dose of methotrexate (MTX).
146003|NCT01764997|O3|Outcome|Sarilumab 200 mg + MTX (Randomized)|Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
146004|NCT01764997|O2|Outcome|Sarilumab 150 mg + MTX (Randomized)|Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
146005|NCT01764997|O1|Outcome|Etanercept + MTX (Randomized)|Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX.
146006|NCT01764997|O3|Outcome|Sarilumab 200 mg + MTX (Randomized)|Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
146007|NCT01764997|O2|Outcome|Sarilumab 150 mg + MTX (Randomized)|Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
146008|NCT01764997|O1|Outcome|Etanercept + MTX (Randomized)|Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX.
146009|NCT01764997|O3|Outcome|Sarilumab 200 mg + MTX (Randomized)|Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
146010|NCT01764997|O2|Outcome|Sarilumab 150 mg + MTX (Randomized)|Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
146011|NCT01764997|O1|Outcome|Etanercept + MTX (Randomized)|Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX.
146012|NCT01764997|O3|Outcome|Sarilumab 200 mg + MTX (Randomized)|Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
146013|NCT01764997|O2|Outcome|Sarilumab 150 mg + MTX (Randomized)|Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
146014|NCT01764997|O1|Outcome|Etanercept + MTX (Randomized)|Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX.
146015|NCT01764997|E5|Reported Event|Sarilumab 150 mg + MTX Open Label Sub-study|Sarilumab 150 mg SC injection Q2W for 52 weeks added to stable dose of MTX. AEs in this group were those collected from enrollment in the sub-study up to the final visit (Week 58).
146016|NCT01764997|E4|Reported Event|Sarilumab 200 mg + MTX (Randomized)|Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX. AEs in this group were those collected post randomization up to the final visit (Week 30).
146017|NCT01764997|E3|Reported Event|Sarilumab 150 mg + MTX (Randomized)|Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX. AEs in this group were those collected post randomization up to the final visit (Week 30).
146018|NCT01764997|E2|Reported Event|Etanercept + MTX (Randomized)|Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX. AEs in this group were those collected post randomization up to the final visit (Week 30).
146019|NCT01764997|E1|Reported Event|Adalimumab Open Label run-in|Adalimumab 40 mg SC injection Q2W for 16 weeks added to stable dose of MTX. AEs in this group were those collected from signature of the informed consent form up to the end of Adalimumab treatment (Week 16).
146020|NCT01764945|B9|Baseline|Total|Total of all reporting groups
146021|NCT01764945|B8|Baseline|120mg Faldaprevir: Sequence Group HGEF|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is HGEF with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
146080|NCT01764841|B2|Baseline|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
164936|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
146022|NCT01764945|B7|Baseline|120mg Faldaprevir: Sequence Group GFHE|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is GFHE with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
146023|NCT01764945|B6|Baseline|120mg Faldaprevir: Sequence Group FEGH|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is FEGH with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
146024|NCT01764945|B5|Baseline|120mg Faldaprevir: Sequence Group EHFG|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is EHFG with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
146025|NCT01764945|B4|Baseline|40mg Faldaprevir: Sequence Group DCAB|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is DCAB with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
146026|NCT01764945|B3|Baseline|40mg Faldaprevir: Sequence Group CBDA|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is CBDA with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
146027|NCT01764945|B2|Baseline|40mg Faldaprevir: Sequence Group BACD|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is BACD with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
146028|NCT01764945|B1|Baseline|40mg Faldaprevir: Sequence Group ADBC|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is ADBC with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
146029|NCT01764945|P8|Participant Flow|120mg Faldaprevir: Sequence Group HGEF|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is HGEF with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
146030|NCT01764945|P7|Participant Flow|120mg Faldaprevir: Sequence Group GFHE|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is GFHE with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
146031|NCT01764945|P6|Participant Flow|120mg Faldaprevir: Sequence Group FEGH|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is FEGH with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
146032|NCT01764945|P5|Participant Flow|120mg Faldaprevir: Sequence Group EHFG|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is EHFG with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
146033|NCT01764945|P4|Participant Flow|40mg Faldaprevir: Sequence Group DCAB|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is DCAB with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
146034|NCT01764945|P3|Participant Flow|40mg Faldaprevir: Sequence Group CBDA|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is CBDA with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
146035|NCT01764945|P2|Participant Flow|40mg Faldaprevir: Sequence Group BACD|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is BACD with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
146134|NCT01764633|O2|Outcome|Evolocumab|Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
146036|NCT01764945|P1|Participant Flow|40mg Faldaprevir: Sequence Group ADBC|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is ADBC with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
146037|NCT01764945|O8|Outcome|120mg Faldaprevir: Treatment H|120 mg faldaprevir oral solution 3
146038|NCT01764945|O7|Outcome|120mg Faldaprevir: Treatment G|120 mg faldaprevir oral solution 2
146039|NCT01764945|O6|Outcome|120mg Faldaprevir: Treatment F|120 mg faldaprevir oral solution 1
146040|NCT01764945|O5|Outcome|120mg Faldaprevir: Treatment E|120 mg faldaprevir soft gelatine capsule (reference).
146041|NCT01764945|O4|Outcome|40mg Faldaprevir: Treatment D|40 mg faldaprevir oral solution 3
146042|NCT01764945|O3|Outcome|40mg Faldaprevir: Treatment C|40 mg faldaprevir oral solution 2
146043|NCT01764945|O2|Outcome|40mg Faldaprevir: Treatment B|40 mg faldaprevir oral solution 1
146044|NCT01764945|O1|Outcome|40mg Faldaprevir: Treatment A|40 mg faldaprevir soft gelatine capsule (reference).
146045|NCT01764945|O8|Outcome|120mg Faldaprevir: Treatment H|120 mg faldaprevir oral solution 3
146046|NCT01764945|O7|Outcome|120mg Faldaprevir: Treatment G|120 mg faldaprevir oral solution 2
146047|NCT01764945|O6|Outcome|120mg Faldaprevir: Treatment F|120 mg faldaprevir oral solution 1
146048|NCT01764945|O5|Outcome|120mg Faldaprevir: Treatment E|120 mg faldaprevir soft gelatine capsule (reference).
146049|NCT01764945|O4|Outcome|40mg Faldaprevir: Treatment D|40 mg faldaprevir oral solution 3
146050|NCT01764945|O3|Outcome|40mg Faldaprevir: Treatment C|40 mg faldaprevir oral solution 2
146051|NCT01764945|O2|Outcome|40mg Faldaprevir: Treatment B|40 mg faldaprevir oral solution 1
146052|NCT01764945|O1|Outcome|40mg Faldaprevir: Treatment A|40 mg faldaprevir soft gelatine capsule (reference).
146053|NCT01764945|O8|Outcome|120mg Faldaprevir: Treatment H|120 mg faldaprevir oral solution 3
146054|NCT01764945|O7|Outcome|120mg Faldaprevir: Treatment G|120 mg faldaprevir oral solution 2
146055|NCT01764945|O6|Outcome|120mg Faldaprevir: Treatment F|120 mg faldaprevir oral solution 1
146056|NCT01764945|O5|Outcome|120mg Faldaprevir: Treatment E|120 mg faldaprevir soft gelatine capsule (reference).
146057|NCT01764945|O4|Outcome|40mg Faldaprevir: Treatment D|40 mg faldaprevir oral solution 3
146058|NCT01764945|O3|Outcome|40mg Faldaprevir: Treatment C|40 mg faldaprevir oral solution 2
146059|NCT01764945|O2|Outcome|40mg Faldaprevir: Treatment B|40 mg faldaprevir oral solution 1
146060|NCT01764945|O1|Outcome|40mg Faldaprevir: Treatment A|40 mg faldaprevir soft gelatine capsule (reference).
146061|NCT01764945|E8|Reported Event|120mg Faldaprevir: Treatment H|120 mg faldaprevir oral solution 3.
146062|NCT01764945|E7|Reported Event|120mg Faldaprevir: Treatment G|120 mg faldaprevir oral solution 2.
146063|NCT01764945|E6|Reported Event|120mg Faldaprevir: Treatment F|120 mg faldaprevir oral solution 1.
146064|NCT01764945|E5|Reported Event|120mg Faldaprevir: Treatment E|120 mg faldaprevir soft gelatine capsule (reference).
146065|NCT01764945|E4|Reported Event|40mg Faldaprevir: Treatment D|40 mg faldaprevir oral solution 3.
146066|NCT01764945|E3|Reported Event|40mg Faldaprevir: Treatment C|40 mg faldaprevir oral solution 2.
146067|NCT01764945|E2|Reported Event|40mg Faldaprevir: Treatment B|40 mg faldaprevir oral solution 1.
146068|NCT01764945|E1|Reported Event|40mg Faldaprevir: Treatment A|40 mg faldaprevir soft gelatine capsule (reference).
146069|NCT01764919|B1|Baseline|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
146070|NCT01764919|P1|Participant Flow|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
146071|NCT01764919|O1|Outcome|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
146072|NCT01764919|O1|Outcome|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
146073|NCT01764919|O1|Outcome|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
146074|NCT01764919|O1|Outcome|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
146075|NCT01764919|O1|Outcome|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
146076|NCT01764919|E1|Reported Event|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
146077|NCT01764841|B5|Baseline|Total|Total of all reporting groups
146078|NCT01764841|B4|Baseline|Placebo 14 Days on/Off (Placebo 14)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
146079|NCT01764841|B3|Baseline|Placebo 28 Days on/Off (Placebo 28)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
146252|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
146081|NCT01764841|B1|Baseline|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
146082|NCT01764841|P4|Participant Flow|Placebo 14 Days on/Off (Placebo 14)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
146083|NCT01764841|P3|Participant Flow|Placebo 28 Days on/Off (Placebo 28)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
146084|NCT01764841|P2|Participant Flow|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
146085|NCT01764841|P1|Participant Flow|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
146086|NCT01764841|O4|Outcome|Placebo 14 Days on/Off (Placebo 14)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
146087|NCT01764841|O3|Outcome|Placebo 28 Days on/Off (Placebo 28)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
146088|NCT01764841|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
146089|NCT01764841|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
146090|NCT01764841|O4|Outcome|Placebo 14 Days on/Off (Placebo 14)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
146091|NCT01764841|O3|Outcome|Placebo 28 Days on/Off (Placebo 28)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
146092|NCT01764841|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
146093|NCT01764841|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
146094|NCT01764841|O3|Outcome|Pooled Placebo|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day or 14-day on-treatment phase followed by a 28-day or 14-day off-treatment phase (48 weeks treatment phase = 6 or 12 cycles).
146095|NCT01764841|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
146096|NCT01764841|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
146097|NCT01764841|O4|Outcome|Placebo 14 Days on/Off (Placebo 14)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
146098|NCT01764841|O3|Outcome|Placebo 28 Days on/Off (Placebo 28)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
146099|NCT01764841|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
146100|NCT01764841|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
146101|NCT01764841|O3|Outcome|Pooled Placebo|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day or 14-day on-treatment phase followed by a 28-day or 14-day off-treatment phase (48 weeks treatment phase = 6 or 12 cycles).
164937|NCT01694108|O2|Outcome|Control Children|No intervention
146102|NCT01764841|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
146103|NCT01764841|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
146104|NCT01764841|O3|Outcome|Pooled Placebo|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day or 14-day on-treatment phase followed by a 28-day or 14-day off-treatment phase (48 weeks treatment phase = 6 or 12 cycles).
146105|NCT01764841|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
146106|NCT01764841|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
146107|NCT01764841|O3|Outcome|Pooled Placebo|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day or 14-day on-treatment phase followed by a 28-day or 14-day off-treatment phase (48 weeks treatment phase = 6 or 12 cycles).
146108|NCT01764841|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
146109|NCT01764841|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
146110|NCT01764841|O3|Outcome|Pooled Placebo|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day or 14-day on-treatment phase followed by a 28-day or 14-day off-treatment phase (48 weeks treatment phase = 6 or 12 cycles).
146111|NCT01764841|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
146112|NCT01764841|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
146113|NCT01764841|E3|Reported Event|Pooled Placebo|Participants received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).
146114|NCT01764841|E2|Reported Event|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
146115|NCT01764841|E1|Reported Event|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
146116|NCT01764685|B3|Baseline|Total|Total of all reporting groups
146117|NCT01764685|B2|Baseline|Placebo Pill + Medical Management|"Sugar pill with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
146118|NCT01764685|B1|Baseline|Topiramate + Medical Management|"Topiramate titrated up to 150 mg/day over 5 wks then maintained for 6 wks + Medical Management sessions for 15-25 mins per study visit~Topiramate: Max therapeutic dose of 150mg/day~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 mins) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
146135|NCT01764633|O1|Outcome|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
146136|NCT01764633|O2|Outcome|Evolocumab|Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
146119|NCT01764685|P2|Participant Flow|Placebo Pill + Medical Management|"Sugar pill with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
146120|NCT01764685|P1|Participant Flow|Topiramate + Medical Management|"Topiramate titrated up to 150 mg/day over 5 weeks then maintained for 6 weeks + Medical Management sessions for 15-25 minutes per study visit~Topiramate: Max therapeutic dose of 150 mg/day~Medical Management: (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
146121|NCT01764685|O2|Outcome|Placebo Pill + Medical Management|"Sugar pill with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
146122|NCT01764685|O1|Outcome|Topiramate + Medical Management|"Topiramate titrated up to 150 mg/day over 5 wks then maintained for 6 wks + Medical Management sessions for 15-25 mins per study visit~Topiramate: Max therapeutic dose of 150mg/day~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/wk."
146123|NCT01764685|E2|Reported Event|Placebo Pill + Medical Management|"Sugar pill with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
146124|NCT01764685|E1|Reported Event|Topiramate + Medical Management|"Topiramate titrated up to 150 mg/day over 5 wks then maintained for 6 weeks + Medical Management sessions for 15-25 minutes per study visit~Topiramate: Max therapeutic dose of 150mg/day~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drink"
146125|NCT01764633|B3|Baseline|Total|Total of all reporting groups
146126|NCT01764633|B2|Baseline|Evolocumab|Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
146127|NCT01764633|B1|Baseline|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
146128|NCT01764633|P2|Participant Flow|Evolocumab|Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
146129|NCT01764633|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
146130|NCT01764633|O2|Outcome|Evolocumab|Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
146131|NCT01764633|O1|Outcome|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
146132|NCT01764633|O2|Outcome|Evolocumab|Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
146133|NCT01764633|O1|Outcome|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
164938|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
146137|NCT01764633|O1|Outcome|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
146138|NCT01764633|O2|Outcome|Evolocumab|Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
146139|NCT01764633|O1|Outcome|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
146140|NCT01764633|O2|Outcome|Evolocumab|Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
146141|NCT01764633|O1|Outcome|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
146142|NCT01764633|O2|Outcome|Evolocumab|Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
146143|NCT01764633|O1|Outcome|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
146144|NCT01764633|O2|Outcome|Evolocumab|Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
146145|NCT01764633|O1|Outcome|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
146146|NCT01764633|O2|Outcome|Evolocumab|Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
146147|NCT01764633|O1|Outcome|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
146148|NCT01764633|E2|Reported Event|Evolocumab|Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
146149|NCT01764633|E1|Reported Event|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
146150|NCT01764607|B1|Baseline|Sirolimus Treatment|"Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.~Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy."
146151|NCT01764607|P1|Participant Flow|Sirolimus Treatment|"Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.~Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy."
146152|NCT01764607|O1|Outcome|Sirolimus Treatment|"Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.~Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy."
146153|NCT01764607|O1|Outcome|Sirolimus Treatment|"Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.~Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy."
146154|NCT01764607|E1|Reported Event|Sirolimus Treatment|"Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.~Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy."
146155|NCT01764386|B3|Baseline|Total|Total of all reporting groups
146156|NCT01764386|B2|Baseline|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
146157|NCT01764386|B1|Baseline|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
146158|NCT01764386|P2|Participant Flow|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff.~The Controlled Treatment Period was from Day 1 to Week 26. The Uncontrolled Treatment Period was from Week 26 to Week 78. At the end of the Controlled Treatment Period (Week 26), subjects assigned to Usual Care were switched to NB+CLI for the duration of the study (Week 78)."
146159|NCT01764386|P1|Participant Flow|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools.~The Controlled Treatment Period was from Day 1 to Week 26. The Uncontrolled Treatment Period was from Week 26 to Week 78. At the end of the Controlled Treatment Period (Week 26), subjects assigned to NB+CLI continued with NB+CLI for the duration of the study (Week 78)."
146160|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
146161|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
146162|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
146163|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
146164|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
146165|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
146166|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
146167|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
146168|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
146169|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
146170|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
146171|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
146172|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
146173|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
146174|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
146175|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
146176|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
146177|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
146178|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
146179|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
146180|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
146181|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
146182|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
146183|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
151888|NCT01739335|O1|Outcome|Mifepristone (600 mg/Day)|600 mg/day mifepristone for one week
146184|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
146185|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
146186|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
146187|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
146188|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
146189|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
146190|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
146191|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
146192|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
146193|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
146194|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
146195|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
146196|NCT01764386|E3|Reported Event|All Subjects (Entire Study)|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools.~All Subjects (Entire Study) consisted of all subjects in both the Controlled and Uncontrolled Treatment Periods. At the end of the Controlled Treatment Period (Week 26), subjects assigned to NB+CLI continued with NB+CLI for the duration of the study and subjects assigned to Usual Care were switched to NB+CLI for the duration of the study."
146197|NCT01764386|E2|Reported Event|Usual Care (Controlled Treatment Period)|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff.~The Controlled Treatment Period was from Day 1 to Week 26."
146198|NCT01764386|E1|Reported Event|NB + CLI (Controlled Treatment Period)|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools.~The Controlled Treatment Period was from Day 1 to Week 26."
146199|NCT01764022|B3|Baseline|Total|Total of all reporting groups
146200|NCT01764022|B2|Baseline|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146201|NCT01764022|B1|Baseline|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146202|NCT01764022|P2|Participant Flow|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146203|NCT01764022|P1|Participant Flow|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146204|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146205|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146206|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146207|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146208|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146209|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146210|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146211|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146212|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146213|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146214|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146215|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146216|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146217|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146218|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146219|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146220|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146221|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146222|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146223|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146224|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146225|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146226|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146227|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146228|NCT01764022|E2|Reported Event|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146229|NCT01764022|E1|Reported Event|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
146230|NCT01763996|B1|Baseline|All Participants|All participants who were randomized and received study drug (febuxostat 80 mg and placebo) during the study.
146231|NCT01763996|P2|Participant Flow|Sequence 2: Placebo + Febuxostat 80 mg|Febuxostat placebo-matching capsules, orally, once daily for 6 weeks in Period 1, followed by febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 2.
146232|NCT01763996|P1|Participant Flow|Sequence 1: Febuxostat 80 mg + Placebo|Febuxostat 80 mg, capsules, orally, once daily for 6 weeks in Period 1, followed by febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 2.
146233|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
146234|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
146235|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
146236|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
146237|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
146238|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
146239|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
146240|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
146241|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
146242|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
146243|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
146244|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
146245|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
146246|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
146247|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
146248|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
146249|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
146250|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
146251|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
146253|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
146254|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
146255|NCT01763996|E2|Reported Event|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
146256|NCT01763996|E1|Reported Event|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
146257|NCT01763918|B5|Baseline|Total|Total of all reporting groups
146258|NCT01763918|B4|Baseline|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146259|NCT01763918|B3|Baseline|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146260|NCT01763918|B2|Baseline|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
146261|NCT01763918|B1|Baseline|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
146262|NCT01763918|P4|Participant Flow|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146263|NCT01763918|P3|Participant Flow|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146264|NCT01763918|P2|Participant Flow|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
146265|NCT01763918|P1|Participant Flow|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
146266|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146267|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146268|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
146269|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
146270|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146271|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146272|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
146273|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
146274|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146275|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146276|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
146277|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
146278|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146279|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146280|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
146281|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
146282|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146283|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146284|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
146285|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
146286|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146287|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146288|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
146289|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
146290|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146291|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146292|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
146293|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
146294|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146295|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146296|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
146297|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
146298|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146299|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146300|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
146301|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
146302|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146303|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146304|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
146305|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
146306|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146307|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146308|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
146309|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
146310|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146311|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146312|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
146313|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
146314|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146315|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146316|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
146317|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
146318|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146319|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146320|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
146321|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
146322|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146323|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146324|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
146325|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
146326|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146327|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146328|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
146329|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
146330|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146331|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146332|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
146333|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
146334|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146335|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146336|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
146337|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
146338|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146339|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146340|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
146341|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
146342|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146343|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146344|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
146345|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
146346|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146347|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146348|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
146349|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
146350|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146351|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146352|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
146353|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
146354|NCT01763918|E4|Reported Event|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146355|NCT01763918|E3|Reported Event|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146356|NCT01763918|E2|Reported Event|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
146357|NCT01763918|E1|Reported Event|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
146358|NCT01763905|B5|Baseline|Total|Total of all reporting groups
146359|NCT01763905|B4|Baseline|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
146360|NCT01763905|B3|Baseline|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
146361|NCT01763905|B2|Baseline|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
146362|NCT01763905|B1|Baseline|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
146363|NCT01763905|P4|Participant Flow|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
146364|NCT01763905|P3|Participant Flow|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
146365|NCT01763905|P2|Participant Flow|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
146366|NCT01763905|P1|Participant Flow|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
146367|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
146368|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
146369|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
146370|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
146371|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
146372|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
146373|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
146374|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
146375|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
146376|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
146377|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
146378|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
146379|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
146380|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
146381|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
146382|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
146383|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
146384|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
146385|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
146386|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
146387|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
146388|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
146389|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
146390|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
146391|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
146392|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
146393|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
146394|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
146395|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
146396|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
146397|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
146398|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
146399|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
146400|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
146401|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
146402|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
146403|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
146404|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
146405|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
146406|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
146407|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
146408|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
146409|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
146410|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
146411|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
146412|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
146413|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
146414|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
146415|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
146416|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
146417|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
146418|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
146419|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
146420|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
146421|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
146422|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
146423|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
146424|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
146425|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
146426|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
146427|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
146428|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
146429|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
146430|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
146431|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
146432|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
146433|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
146434|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
146435|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
146436|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
146437|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
146438|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
146439|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
146440|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
146441|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
146442|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
146443|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
146444|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
146445|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
146446|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
146447|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
146448|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
146449|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
146450|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
146451|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
146452|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
146453|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
146454|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
146455|NCT01763905|E4|Reported Event|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
146456|NCT01763905|E3|Reported Event|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
146457|NCT01763905|E2|Reported Event|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
146458|NCT01763905|E1|Reported Event|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
146459|NCT01763866|B25|Baseline|Total|Total of all reporting groups
146460|NCT01763866|B24|Baseline|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146461|NCT01763866|B23|Baseline|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146462|NCT01763866|B22|Baseline|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146463|NCT01763866|B21|Baseline|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146464|NCT01763866|B20|Baseline|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
147086|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
146465|NCT01763866|B19|Baseline|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146466|NCT01763866|B18|Baseline|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146467|NCT01763866|B17|Baseline|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146468|NCT01763866|B16|Baseline|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146469|NCT01763866|B15|Baseline|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146470|NCT01763866|B14|Baseline|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146471|NCT01763866|B13|Baseline|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146472|NCT01763866|B12|Baseline|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146473|NCT01763866|B11|Baseline|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146474|NCT01763866|B10|Baseline|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146475|NCT01763866|B9|Baseline|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
146476|NCT01763866|B8|Baseline|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146477|NCT01763866|B7|Baseline|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146478|NCT01763866|B6|Baseline|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146479|NCT01763866|B5|Baseline|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146480|NCT01763866|B4|Baseline|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146481|NCT01763866|B3|Baseline|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
146482|NCT01763866|B2|Baseline|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
146483|NCT01763866|B1|Baseline|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
146484|NCT01763866|P24|Participant Flow|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146485|NCT01763866|P23|Participant Flow|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146486|NCT01763866|P22|Participant Flow|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146487|NCT01763866|P21|Participant Flow|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146488|NCT01763866|P20|Participant Flow|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146489|NCT01763866|P19|Participant Flow|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146490|NCT01763866|P18|Participant Flow|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146491|NCT01763866|P17|Participant Flow|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146492|NCT01763866|P16|Participant Flow|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146493|NCT01763866|P15|Participant Flow|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146494|NCT01763866|P14|Participant Flow|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146495|NCT01763866|P13|Participant Flow|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146496|NCT01763866|P12|Participant Flow|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146497|NCT01763866|P11|Participant Flow|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146498|NCT01763866|P10|Participant Flow|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146499|NCT01763866|P9|Participant Flow|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
146500|NCT01763866|P8|Participant Flow|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146501|NCT01763866|P7|Participant Flow|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146502|NCT01763866|P6|Participant Flow|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146503|NCT01763866|P5|Participant Flow|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146504|NCT01763866|P4|Participant Flow|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146505|NCT01763866|P3|Participant Flow|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
146506|NCT01763866|P2|Participant Flow|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
146507|NCT01763866|P1|Participant Flow|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
146508|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146509|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146510|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146511|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146512|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146513|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146514|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146515|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146516|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146517|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146518|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146519|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146602|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
146520|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146521|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146522|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146523|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
146524|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146525|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146526|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146527|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146528|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146529|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
146530|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
146531|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
146532|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146533|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146534|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146535|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146536|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146537|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146538|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146539|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146540|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146541|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146542|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146543|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146544|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146545|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146546|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146631|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146547|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
146548|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146549|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146550|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146551|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146552|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146553|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
146554|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
146555|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
146556|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146557|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146558|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146559|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146560|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146561|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146562|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146563|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146564|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146565|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146566|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146567|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146568|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146569|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146570|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146571|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
146572|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146573|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146574|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146575|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146576|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146577|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
146578|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
146579|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
146580|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146581|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146582|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146583|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146584|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146585|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146586|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146587|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146588|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146589|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146590|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146591|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146592|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146593|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146594|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146595|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
146596|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146597|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146598|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146599|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146600|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146601|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
147087|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
146603|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
146604|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146605|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146606|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146607|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146608|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146609|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146610|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146611|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146612|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146613|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146614|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146615|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146616|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146617|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146618|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146619|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
146620|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146621|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146622|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146623|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146624|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146625|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
146626|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
146627|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
146628|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146629|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146630|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146632|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146633|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146634|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146635|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146636|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146637|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146638|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146639|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146640|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146641|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146642|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146643|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
146644|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146645|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146646|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146647|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146648|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146649|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
146650|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
146651|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
146652|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146653|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146654|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146655|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146656|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146657|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146658|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146659|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
151889|NCT01739335|O2|Outcome|Sugar Pill|Placebo (sugar pill) for one week
146660|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146661|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146662|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146663|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146664|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146665|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146666|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146667|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
146668|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146669|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146670|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146671|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146672|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146673|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
146674|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
146675|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
146676|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146677|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146678|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146679|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146680|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146681|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146682|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146683|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146684|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146685|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146686|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146687|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
151890|NCT01739335|O1|Outcome|Mifepristone (600 mg/Day)|600 mg/day mifepristone for one week
146688|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146689|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146690|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146691|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
146692|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146693|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146694|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146695|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146696|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146697|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
146698|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
146699|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
146700|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146701|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146702|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146703|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146704|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146705|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146706|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146707|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146708|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146709|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146710|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146711|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146712|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146713|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146714|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146770|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
146715|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
146716|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146717|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146718|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146719|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146720|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146721|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
146722|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
146723|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
146724|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146725|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146726|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146727|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146728|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146729|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146730|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146731|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146732|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146733|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146734|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146735|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146736|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146737|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146738|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146739|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
146740|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146741|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146742|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146743|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146744|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146745|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
146746|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
146747|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
146748|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146749|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146750|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146751|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146752|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146753|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146754|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146755|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146756|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146757|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146758|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146759|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146760|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146761|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146762|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146763|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
146764|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146765|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146766|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146767|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146768|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146769|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
146966|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146771|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
146772|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146773|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146774|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146775|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146776|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146777|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146778|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146779|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146780|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146781|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146782|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146783|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146784|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146785|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146786|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146787|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
146788|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146789|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146790|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146791|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146792|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146793|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
146794|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
146795|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
146796|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146797|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146798|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146799|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146800|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146801|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146802|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146803|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146804|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146805|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146806|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146807|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146808|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146809|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146810|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146811|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
146812|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146813|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146814|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146815|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146816|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146817|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
146818|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
146819|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
146820|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146821|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146822|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146823|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146824|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146825|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146826|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
151891|NCT01739335|O2|Outcome|Sugar Pill|Placebo (sugar pill) for one week
146827|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146828|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146829|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146830|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146831|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146832|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146833|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146834|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146835|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
146836|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146837|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146838|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146839|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146840|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146841|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
146842|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
146843|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
146844|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146845|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146846|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146847|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146848|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146849|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146850|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146851|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146852|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146853|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146854|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
151892|NCT01739335|O1|Outcome|Mifepristone (600 mg/Day)|600 mg/day mifepristone for one week
146855|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146856|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146857|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146858|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146859|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
146860|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146861|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146862|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146863|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146864|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146865|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
146866|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
146867|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
146868|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146869|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146870|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146871|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146872|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146873|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146874|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146875|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146876|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146877|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146878|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146879|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146880|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146881|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146882|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146883|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
146884|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146885|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146886|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146887|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146888|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146889|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
146890|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
146891|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
146892|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146893|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146894|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146895|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146896|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146897|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146898|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146899|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146900|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146901|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146902|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146903|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146904|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146905|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146906|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146907|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
146908|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146909|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146910|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146911|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146912|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146913|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
146914|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
146915|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
146916|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146917|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146918|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146919|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146920|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146921|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146922|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146923|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146924|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146925|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146926|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146927|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146928|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146929|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146930|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146931|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
146932|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146933|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146934|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146935|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146936|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146937|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
147084|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
146938|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
146939|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
146940|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146941|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146942|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146943|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146944|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146945|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146946|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146947|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146948|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146949|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146950|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146951|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146952|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146953|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146954|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146955|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
146956|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146957|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146958|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146959|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146960|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146961|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
146962|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
146963|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
146964|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146965|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146967|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146968|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146969|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146970|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146971|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146972|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146973|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146974|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146975|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146976|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146977|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146978|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146979|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
146980|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146981|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146982|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
146983|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
146984|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
146985|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
146986|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
146987|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
146988|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146989|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146990|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146991|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146992|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146993|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146994|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
151893|NCT01739335|O2|Outcome|Sugar Pill|Placebo (sugar pill) for one week
146995|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
146996|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
146997|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
146998|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
146999|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
147000|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
147001|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
147002|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
147003|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
147004|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
147005|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
147006|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
147007|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
147008|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
147009|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
147010|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
147011|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
147012|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
147013|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
147014|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
147015|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
147016|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
147017|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
147018|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
147019|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
147020|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
147021|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
147022|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
151894|NCT01739335|O1|Outcome|Mifepristone (600 mg/Day)|600 mg/day mifepristone for one week
147023|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
147024|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
147025|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
147026|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
147027|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
147028|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
147029|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
147030|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
147031|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
147032|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
147033|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
147034|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
147035|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
147036|NCT01763866|E24|Reported Event|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
147037|NCT01763866|E23|Reported Event|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
147038|NCT01763866|E22|Reported Event|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
147039|NCT01763866|E21|Reported Event|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
147040|NCT01763866|E20|Reported Event|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
147041|NCT01763866|E19|Reported Event|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
147042|NCT01763866|E18|Reported Event|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
147043|NCT01763866|E17|Reported Event|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
147044|NCT01763866|E16|Reported Event|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
147045|NCT01763866|E15|Reported Event|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
147046|NCT01763866|E14|Reported Event|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
147047|NCT01763866|E13|Reported Event|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
147048|NCT01763866|E12|Reported Event|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
147049|NCT01763866|E11|Reported Event|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
147085|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
147050|NCT01763866|E10|Reported Event|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
147051|NCT01763866|E9|Reported Event|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
147052|NCT01763866|E8|Reported Event|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
147053|NCT01763866|E7|Reported Event|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
147054|NCT01763866|E6|Reported Event|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
147055|NCT01763866|E5|Reported Event|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
147056|NCT01763866|E4|Reported Event|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
147057|NCT01763866|E3|Reported Event|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
147058|NCT01763866|E2|Reported Event|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
147059|NCT01763866|E1|Reported Event|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
147060|NCT01763827|B7|Baseline|Total|Total of all reporting groups
147061|NCT01763827|B6|Baseline|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
147062|NCT01763827|B5|Baseline|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
147063|NCT01763827|B4|Baseline|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
147064|NCT01763827|B3|Baseline|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
147065|NCT01763827|B2|Baseline|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
147066|NCT01763827|B1|Baseline|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
147067|NCT01763827|P6|Participant Flow|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
147068|NCT01763827|P5|Participant Flow|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
147069|NCT01763827|P4|Participant Flow|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
147070|NCT01763827|P3|Participant Flow|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
147071|NCT01763827|P2|Participant Flow|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
147072|NCT01763827|P1|Participant Flow|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
147073|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
147074|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
147075|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
147076|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
147077|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
147078|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
147079|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
147080|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
147081|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
147082|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
147083|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
147511|NCT01761279|B1|Baseline|HDWL + I-Scan|High Definition White Light Endoscopy and i-Scan assessment performed of all polyps
147088|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
147089|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
147090|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
147091|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
147092|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
147093|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
147094|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
147095|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
147096|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
147097|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
147098|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
147099|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
147100|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
147101|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
147102|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
147103|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
147104|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
147105|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
147106|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
147107|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
147108|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
147109|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
147110|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
147111|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
147112|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
147113|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
147114|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
147115|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
147116|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
147117|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
147118|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
147119|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
147120|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
147121|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
147122|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
147123|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
147124|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
147125|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
147126|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
147512|NCT01761279|P1|Participant Flow|HDWL and i-Scan Assessment|High Definition White Light Endoscopy.
147127|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
147128|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
147129|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
147130|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
147131|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
147132|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
147133|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
147134|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
147135|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
147136|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
147137|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
147138|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
147139|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
147140|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
147141|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
147142|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
147143|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
147144|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
147145|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
147146|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
147147|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
147148|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
147149|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
147150|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
147151|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
147152|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
147153|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
147154|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
147155|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
147156|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
147157|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
147158|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
147159|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
147160|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
147161|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
147162|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
147163|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
147164|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
147165|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
147513|NCT01761279|O2|Outcome|i-Scan|High definition white light endoscopy with i-Scan image enhancement
147166|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
147167|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
147168|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
147169|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
147170|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
147171|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
147172|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
147173|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
147174|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
147175|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
147176|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
147177|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
147178|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
147179|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
147180|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
147181|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
147182|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
147183|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
147184|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
147185|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
147186|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
147187|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
147188|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
147189|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
147190|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
147191|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
147192|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
147193|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
147194|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
147195|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
147196|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
147197|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
147198|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
147199|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
147200|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
147201|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
147202|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
147203|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
147204|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
147514|NCT01761279|O1|Outcome|HDWL|High Definition White Light Endoscopy
147205|NCT01763827|E6|Reported Event|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
147206|NCT01763827|E5|Reported Event|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
147207|NCT01763827|E4|Reported Event|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
147208|NCT01763827|E3|Reported Event|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
147209|NCT01763827|E2|Reported Event|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
147210|NCT01763827|E1|Reported Event|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
147211|NCT01763645|B3|Baseline|Total|Total of all reporting groups
147212|NCT01763645|B2|Baseline|Avastin (F. Hoffmann-La Roche Ltd)|"In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel.~Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1.~Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1."
147213|NCT01763645|B1|Baseline|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
147214|NCT01763645|P2|Participant Flow|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
147215|NCT01763645|P1|Participant Flow|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
147216|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
147217|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
147218|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
147219|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
147220|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
147221|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
147222|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
147223|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
147251|NCT01763047|O2|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B during either the first or second period of the study. Subjects were then stratified by sphere power as either Hyperopes or Myopes.
147224|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
147225|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
147226|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
147227|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
147228|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|"In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel.~Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1.~Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1."
147229|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
147230|NCT01763645|E2|Reported Event|Avastin (F. Hoffmann-La Roche Ltd)|"In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1.~Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.~Data on adverse events was collected from date of signing informed consent up to 18 weeks after first injection of study drug."
147231|NCT01763645|E1|Reported Event|BCD-021 (CISC BIOCAD)|"In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.~Data on adverse events was collected from date of signing informed consent up to 18 weeks after first injection of study drug."
147232|NCT01763567|B1|Baseline|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
147233|NCT01763567|P1|Participant Flow|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
147234|NCT01763567|O1|Outcome|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
147235|NCT01763567|O1|Outcome|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
147236|NCT01763567|O1|Outcome|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
147237|NCT01763567|O1|Outcome|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
147238|NCT01763567|O1|Outcome|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
147239|NCT01763567|E1|Reported Event|Observation Arm|To assess safety and device performance for the Hospital Glucose Managment system
147240|NCT01763047|B3|Baseline|Total|Total of all reporting groups
147241|NCT01763047|B2|Baseline|Lotrafilcon B/ Etafilcon A|Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the lotrafilcon B and then received the etafilcon A.
147242|NCT01763047|B1|Baseline|Etafilcon A/ Lotrafilcon B|Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the etafilcon A and then received the lotrafilcon B.
147243|NCT01763047|P2|Participant Flow|Lotrafilcon B/ Etafilcon A|Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the lotrafilcon B lens and then received the etafilcon A lens.
147244|NCT01763047|P1|Participant Flow|Etafilcon A/ Lotrafilcon B|Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the etafilcon A lens and then received the lotrafilcon B lens.
147245|NCT01763047|O2|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
147246|NCT01763047|O1|Outcome|Etafilcon A|Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
147247|NCT01763047|O2|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
147248|NCT01763047|O1|Outcome|Etafilcon A|Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
147249|NCT01763047|O2|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
147250|NCT01763047|O1|Outcome|Etafilcon A|Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
147515|NCT01761279|O2|Outcome|i-Scan|High definition white light endoscopy with i-Scan image enhancement
147252|NCT01763047|O1|Outcome|Etafilcon A|Subjects that were dispensed the etafilcon A during either the first or second period of the study. Subjects were then stratified by sphere power as either Hyperopes or Myopes.
147253|NCT01763047|O2|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B during either the first or second period of the study.
147254|NCT01763047|O1|Outcome|Etafilcon A|Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
147255|NCT01763047|O2|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
147256|NCT01763047|O1|Outcome|Etafilcon A|Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
147257|NCT01763047|E2|Reported Event|Control (Lotrafilcon B)|Subjects that were dispensed the Control lens (lotrafilcon B) during either the first or second period of the study.
147258|NCT01763047|E1|Reported Event|Test (Etafilcon A)|Subjects that were dispensed the Test lens (etafilcon A) during either the first or second period of the study.
147259|NCT01762982|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline parameters.
147260|NCT01762982|P1|Participant Flow|Overall|This was a 4-way split-plot clinical study. Four Finn chambers which contained the test product (Benzalkonium chloride solution; 0.03 milliliters (mL) of 0.13% Benazalkonium chloride solution), one positive control [Sodium lauryl sulphate (SLS); 0.03 mL of 0.3% weight by weight (w/w) SLS solution] and 2 negative controls including one chamber for normal saline (0.03 mL of 0.9% weight by volume (w/v) normal saline) and an empty Finn chamber were applied on the left upper back of each subject for 24 hours under occlusive dressing. The sequence of the patch assembly (Finn chambers) was randomized. During this 24 hour patch applications, subjects had direct and ongoing skin contact with the investigational products and the positive and negative controls.
147261|NCT01762982|O2|Outcome|Normal Saline Water|0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
147262|NCT01762982|O1|Outcome|Benzalkonium Chloride Solution|0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
147263|NCT01762982|O2|Outcome|Normal Saline Water|0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
147264|NCT01762982|O1|Outcome|Benzalkonium Chloride Solution|0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
147265|NCT01762982|O4|Outcome|Empty Finn Chamber|Empty Finn Chamber (a patch test device) was applied to upper back of participants for 24 hours.
147266|NCT01762982|O3|Outcome|Normal Saline Water|0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
147267|NCT01762982|O2|Outcome|SLS Solution|0.03 mL of 0.3% w/w SLS solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
147268|NCT01762982|O1|Outcome|Benzalkonium Chloride Solution|0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
147269|NCT01762982|O4|Outcome|Empty Finn Chamber|Empty Finn Chamber (a patch test device) was applied to upper back of participants for 24 hours.
147270|NCT01762982|O3|Outcome|Normal Saline Water|0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
147271|NCT01762982|O2|Outcome|SLS Solution|0.03 mL of 0.3% w/w SLS solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
147272|NCT01762982|O1|Outcome|Benzalkonium Chloride Solution|0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
147273|NCT01762982|O2|Outcome|Normal Saline Water|0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
147274|NCT01762982|O1|Outcome|Benzalkonium Chloride Solution|0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
147275|NCT01762982|O4|Outcome|Empty Finn Chamber|Empty Finn Chamber (a patch test device) was applied to upper back of participants for 24 hours.
147276|NCT01762982|O3|Outcome|Normal Saline Water|0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
147277|NCT01762982|O2|Outcome|SLS Solution|0.03 mL of 0.3% w/w SLS solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
147278|NCT01762982|O1|Outcome|Benzalkonium Chloride Solution|0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
147279|NCT01762982|E1|Reported Event|Overall Study|"This was a 4-way split-plot study. Four Finn chambers which contained the test product (Benzalkonium chloride solution; 0.03 mL of 0.13% Benazalkonium chloride solution), one positive control [SLS; 0.03 mL of 0.3% w/w SLS solution] and 2 negative controls including one chamber for normal saline (0.03 mL of 0.9% w/v normal saline) and an empty Finn chamber were applied on the left upper back of each subject for 24 hours under occlusive dressing. The sequence of the patch assembly (Finn chambers) was randomized. During this 24 hour patch applications, subjects had direct and ongoing skin contact with the investigational products and the positive and negative controls.~All randomized participants exposed to at least one of the study treatments were evaluated for safety."
147280|NCT01762943|B3|Baseline|Total|Total of all reporting groups
147281|NCT01762943|B2|Baseline|Women Without Any Psychiatric History (Control)|"4 monthly IM injections of leuprolide acetate (Lupron) 3.75 mg; micronized estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day; progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day. Participants will also receive placebo.~Leuprolide Acetate: All subjects will receive one IM injection (3.75 mg) each month for four months.~Micronized estradiol: All participants will receive micronized estradiol daily for eight weeks. Estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day.~Progesterone: All subjects will receive micronized progesterone daily for eight weeks. Progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day."
147406|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147282|NCT01762943|B1|Baseline|Women With Postpartum Depression (PPD)|"4 monthly IM injections of leuprolide acetate (Lupron) 3.75 mg; micronized estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day; progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day. Participants will also receive placebo.~Leuprolide Acetate: All subjects will receive one IM injection (3.75 mg) each month for four months.~Micronized estradiol: All participants will receive micronized estradiol daily for eight weeks. Estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day.~Progesterone: All subjects will receive micronized progesterone daily for eight weeks. Progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day."
147283|NCT01762943|P2|Participant Flow|Women Without Any Psychiatric History (Control)|"4 monthly IM injections of leuprolide acetate (Lupron) 3.75 mg; micronized estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day; progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day. Participants will also receive placebo.~Leuprolide Acetate: All subjects will receive one IM injection (3.75 mg) each month for four months.~Micronized estradiol: All participants will receive micronized estradiol daily for eight weeks. Estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day.~Progesterone: All subjects will receive micronized progesterone daily for eight weeks. Progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day."
147284|NCT01762943|P1|Participant Flow|Women With Postpartum Depression (PPD)|"4 monthly intramuscular (IM) injections of leuprolide acetate (Lupron) 3.75 mg; micronized estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day; progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day. Participants will also receive placebo.~Leuprolide Acetate: All subjects will receive one IM injection (3.75 mg) each month for four months.~Micronized estradiol: All participants will receive micronized estradiol daily for eight weeks. Estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day.~Progesterone: All subjects will receive micronized progesterone daily for eight weeks. Progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day."
147285|NCT01762943|O2|Outcome|Women Without Any Psychiatric History (Control)|"4 monthly IM injections of leuprolide acetate (Lupron) 3.75 mg; micronized estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day; progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day. Participants will also receive placebo.~Leuprolide Acetate: All subjects will receive one IM injection (3.75 mg) each month for four months.~Micronized estradiol: All participants will receive micronized estradiol daily for eight weeks. Estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day.~Progesterone: All subjects will receive micronized progesterone daily for eight weeks. Progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day."
147286|NCT01762943|O1|Outcome|Women With a History of Postpartum Depression (PPD)|"4 monthly IM injections of leuprolide acetate (Lupron) 3.75 mg; micronized estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day; progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day. Participants will also receive placebo.~Leuprolide Acetate: All subjects will receive one IM injection (3.75 mg) each month for four months.~Micronized estradiol: All participants will receive micronized estradiol daily for eight weeks. Estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day.~Progesterone: All subjects will receive micronized progesterone daily for eight weeks. Progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day."
147287|NCT01762943|O2|Outcome|Women Without Any Psychiatric History (Control)|"4 monthly IM injections of leuprolide acetate (Lupron) 3.75 mg; micronized estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day; progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day. Participants will also receive placebo.~Leuprolide Acetate: All subjects will receive one IM injection (3.75 mg) each month for four months.~Micronized estradiol: All participants will receive micronized estradiol daily for eight weeks. Estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day.~Progesterone: All subjects will receive micronized progesterone daily for eight weeks. Progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day."
147288|NCT01762943|O1|Outcome|Women With a History of Postpartum Depression (PPD)|"4 monthly IM injections of leuprolide acetate (Lupron) 3.75 mg; micronized estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day; progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day. Participants will also receive placebo.~Leuprolide Acetate: All subjects will receive one IM injection (3.75 mg) each month for four months.~Micronized estradiol: All participants will receive micronized estradiol daily for eight weeks. Estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day.~Progesterone: All subjects will receive micronized progesterone daily for eight weeks. Progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day."
147289|NCT01762943|E2|Reported Event|Women Without Any Psychiatric History (Control)|"4 monthly IM injections of leuprolide acetate (Lupron) 3.75 mg; micronized estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day; progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day. Participants will also receive placebo.~Leuprolide Acetate: All subjects will receive one IM injection (3.75 mg) each month for four months.~Micronized estradiol: All participants will receive micronized estradiol daily for eight weeks. Estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day.~Progesterone: All subjects will receive micronized progesterone daily for eight weeks. Progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day."
147290|NCT01762943|E1|Reported Event|Women With Postpartum Depression (PPD)|"4 monthly IM injections of leuprolide acetate (Lupron) 3.75 mg; micronized estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day; progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day. Participants will also receive placebo.~Leuprolide Acetate: All subjects will receive one IM injection (3.75 mg) each month for four months.~Micronized estradiol: All participants will receive micronized estradiol daily for eight weeks. Estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day.~Progesterone: All subjects will receive micronized progesterone daily for eight weeks. Progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day."
147452|NCT01762501|E2|Reported Event|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
147291|NCT01762904|B1|Baseline|Whole Group of 135 Units of Measurement|"The arm is composed of 135 units of measurement, it means, 540 determinations to test 2% chlorhexidine gluconate in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol and two controls.~The principal unit of measurement it will be four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites, and determination as to each separately sampling for each area for each antiseptic forearm. The same subject may be assessed up to three separate occasions provided only after a minimum period of two weeks between each determination.~Interventions:~Biological: Bacterial culture of the prepared skin's areas with two antiseptics and two controls~Other: Preparing skin's areas to be tested with two antiseptics and two controls"
147292|NCT01762904|P1|Participant Flow|Whole Group of 135 Units of Measurement|"The arm is composed of 135 units of measurement, it means, 540 determinations to test 2% chlorhexidine gluconate in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol and two controls.~The principal unit of measurement it will be four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites, and determination as to each separately sampling for each area for each antiseptic forearm. The same subject may be assessed up to three separate occasions provided only after a minimum period of two weeks between each determination.~Interventions:~Biological: Bacterial culture of the prepared skin's areas with two antiseptics and two controls~Other: Preparing skin's areas to be tested with two antiseptics and two controls"
147293|NCT01762904|O1|Outcome|Whole Group of 135 Units of Measurement|"135 units of measurement to test two antiseptics and two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol, Deionized water redistilled and Scrub the skin without prior application of any substance was tested. Were prepared four skin's areas of 25 cm2, two in each forearm. The solution remained on the skin for 60s, 3h and 24h.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."
147294|NCT01762904|O1|Outcome|Whole Group of 135 Units of Measurement|"135 determinations to test two controls: Deionized water redistilled and Scrub the skin without prior application of any substance was tested.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. Deionized water redistilled and Scrub the skin without prior application of any substance was tested.~Were prepared two skin's areas of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."
147295|NCT01762904|O1|Outcome|Whole Group of 135 Units of Measurement|"135 determinations to test 1% triclosan in 70% isopropyl alcohol.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 1% triclosan in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."
147296|NCT01762904|O1|Outcome|Whole Group of 135 Units of Measurement|"135 determinations to test 2% chlorhexidine in 70% isopropyl alcohol.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."
147297|NCT01762904|E1|Reported Event|Whole Group of 135 Units of Measurement|"135 units of measurement to test two antiseptics and two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol, Deionized water redistilled and Scrub the skin without prior application of any substance was tested. Were prepared four skin's areas of 25 cm2, two in each forearm. The solution remained on the skin for 60s, 3h and 24h.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."
147298|NCT01762800|B3|Baseline|Total|Total of all reporting groups
147299|NCT01762800|B2|Baseline|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
147300|NCT01762800|B1|Baseline|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
147301|NCT01762800|P2|Participant Flow|SAL/FLU 50/250 µg BID|Participants received 50/250 µg salmeterol xinafoate (SAL)/fluticasone propionate (FLU) BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
147407|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147302|NCT01762800|P1|Participant Flow|TIO 18 µg QD|Participants received 18 micrograms (µg) tiotropium bromide (TIO) once daily (QD) via HandiHaler inhaler and placebo twice daily (BID) via dry powder inhaler (DPI), during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
147303|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
147304|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
147305|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
147306|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
147307|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
147308|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
147309|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
147310|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
147311|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
147312|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
147313|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
147314|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
147315|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
147316|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
147317|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
147318|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
147408|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147516|NCT01761279|O1|Outcome|HDWL|High Definition White Light Endoscopy
147319|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
147320|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
147321|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
147322|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
147323|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
147324|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
147325|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
147326|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
147327|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
147328|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
147329|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
147330|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
147331|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
147332|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
147333|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
147334|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
151895|NCT01739335|O2|Outcome|Sugar Pill|Placebo (sugar pill) for one week
147335|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
147336|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
147337|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
147338|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
147339|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
147340|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
147341|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
147342|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
147343|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
147344|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
147345|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
147346|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
147347|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
147348|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
147349|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
147350|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
147409|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147351|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
147352|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
147353|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
147354|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
147355|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
147356|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
147357|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
147358|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
147359|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
147360|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
147361|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
147362|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
147363|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
147364|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
147365|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
147366|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
147367|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
147368|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
147410|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147517|NCT01761279|O2|Outcome|i-Scan|High definition white light endoscopy with i-Scan image enhancement
147369|NCT01762800|E4|Reported Event|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
147370|NCT01762800|E3|Reported Event|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
147371|NCT01762800|E2|Reported Event|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
147372|NCT01762800|E1|Reported Event|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
147373|NCT01762761|B3|Baseline|Total|Total of all reporting groups
147374|NCT01762761|B2|Baseline|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147375|NCT01762761|B1|Baseline|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147376|NCT01762761|P2|Participant Flow|Eltrombopag|Participants initially received eltrombopag 25 milligrams (mg) QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147377|NCT01762761|P1|Participant Flow|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147378|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
147379|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
147380|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
147381|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
147382|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
147383|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
147411|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147453|NCT01762501|E1|Reported Event|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
147384|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
147385|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
147386|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
147387|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
147388|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147389|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147390|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147391|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147392|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147393|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147394|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147395|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147396|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147397|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147398|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147399|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147400|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147401|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147402|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147403|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147404|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147405|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147451|NCT01762501|O1|Outcome|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
147412|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147413|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147414|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147415|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147416|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147417|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147418|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147419|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147420|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147421|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147422|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147423|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147424|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147425|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147426|NCT01762761|E2|Reported Event|Eltrombopag|Participants initially received eltrombopag 25 milligrams (mg) QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147427|NCT01762761|E1|Reported Event|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
147428|NCT01762722|B3|Baseline|Total|Total of all reporting groups
147429|NCT01762722|B2|Baseline|Validation|Group of subjects in whom the final algorithm is tested.
147430|NCT01762722|B1|Baseline|Calibration|Initial group of subjects on whom the test algorithm is developed.
147431|NCT01762722|P2|Participant Flow|Validation|Group of subjects in whom the final algorithm is tested.
147432|NCT01762722|P1|Participant Flow|Calibration|Initial group of subjects on whom the test algorithm is developed.
147433|NCT01762722|O2|Outcome|Validation|Group of subjects in whom the final algorithm is tested.
147434|NCT01762722|O1|Outcome|Calibration|Initial group of subjects on whom the test algorithm is developed.
147435|NCT01762722|E2|Reported Event|Validation|Group of subjects in whom the final algorithm is tested.
147436|NCT01762722|E1|Reported Event|Calibration|Initial group of subjects on whom the test algorithm is developed.
147437|NCT01762501|B3|Baseline|Total|Total of all reporting groups
147438|NCT01762501|B2|Baseline|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
147439|NCT01762501|B1|Baseline|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
147440|NCT01762501|P2|Participant Flow|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
147441|NCT01762501|P1|Participant Flow|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
147442|NCT01762501|O2|Outcome|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
147443|NCT01762501|O1|Outcome|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
147444|NCT01762501|O2|Outcome|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
147445|NCT01762501|O1|Outcome|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
147446|NCT01762501|O2|Outcome|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
147447|NCT01762501|O1|Outcome|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
147448|NCT01762501|O2|Outcome|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
147449|NCT01762501|O1|Outcome|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
147450|NCT01762501|O2|Outcome|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
147459|NCT01762345|O1|Outcome|Pessary Device|"pessary (disposable intra-vaginal device)~pessary (disposable intra-vaginal device): pessary device(disposable intra-vaginal device)manufactured by Procter & Gamble"
147460|NCT01762345|O1|Outcome|Pessary Device|pessary (disposable intra-vaginal device)
147461|NCT01762345|O1|Outcome|Pessary Device|pessary (disposable intra-vaginal device)
147462|NCT01762345|O1|Outcome|Pessary Device|pessary (disposable intra-vaginal device)
147463|NCT01762345|E1|Reported Event|Pessary Device|pessary (disposable intra-vaginal device)
147464|NCT01762059|B1|Baseline|All Participants|
147465|NCT01762059|P1|Participant Flow|All Participants: Bi-hormonal Bionic Pancreas and Usual Care|"Closed-loop blood glucose control with a bi-hormonal bionic endocrine pancreas designed by Edward Damiano and Firas El-Khatib of Boston University. The device will deliver insulin lispro (Humalog) and glucagon based on blood glucose levels estimated by a continuous glucose monitoring device (Dexcom G4 Platinum) and a proprietary dosing algorithm. Blood glucose control will be automated for 5 days during which volunteers will sleep in a hotel and roam freely in downtown Boston during the day. There will be no restrictions on diet or exercise.~After the first experimental period, there was a two-day washout period followed by the second experimental period.~Usual care for 5 days (insulin pump therapy according to usual practice), volunteers will sleep at home and maintain their usual schedule during the day, there will be no restrictions on diet or exercise, they will wear a blinded CGM~Usual care"
147466|NCT01762059|O2|Outcome|Usual Care|
147467|NCT01762059|O1|Outcome|Bionic Pancreas|
147468|NCT01762059|O2|Outcome|Usual Care|
147469|NCT01762059|O1|Outcome|Bionic Pancreas|
147470|NCT01762059|O1|Outcome|All Participants|
147471|NCT01762059|O2|Outcome|Usual Care|
147472|NCT01762059|O1|Outcome|Bionic Pancreas|
147473|NCT01762059|O1|Outcome|All Participants|
147474|NCT01762059|O1|Outcome|All Participants|
147475|NCT01762059|O1|Outcome|All Participants|
147476|NCT01762059|O1|Outcome|All Participants|
147477|NCT01762059|O1|Outcome|All Participants|
147478|NCT01762059|O1|Outcome|Bionic Pancreas|Closed loop blood glucose control using a bihormonal bionic endocrine pancreas delivering insulin and glucagon using continuous glucose monitor readings, with doses calculated by a computer algorithm every 5 minutes .
147479|NCT01762059|O1|Outcome|All Participants|
147480|NCT01762059|O1|Outcome|All Participants|
147481|NCT01762059|O1|Outcome|All Participants|
147482|NCT01762059|O1|Outcome|All Participants|
147483|NCT01762059|O1|Outcome|Bionic Pancreas|
147484|NCT01762059|O1|Outcome|All Participants|
147485|NCT01762059|O1|Outcome|All Participants|
147486|NCT01762059|O1|Outcome|All Participants: Bi-hormonal Bionic Pancreas and Usual Care|"Closed-loop blood glucose control with a bi-hormonal bionic endocrine pancreas designed by Edward Damiano and Firas El-Khatib of Boston University. The device will deliver insulin lispro (Humalog) and glucagon based on blood glucose levels estimated by a continuous glucose monitoring device (Dexcom G4 Platinum) and a proprietary dosing algorithm. Blood glucose control will be automated for 5 days during which volunteers will sleep in a hotel and roam freely in downtown Boston during the day. There will be no restrictions on diet or exercise.~After the first experimental period, there was a two-day washout period followed by the second experimental period.~Usual care for 5 days (insulin pump therapy according to usual practice), volunteers will sleep at home and maintain their usual schedule during the day, there will be no restrictions on diet or exercise, they will wear a blinded CGM~Usual care"
147487|NCT01762059|O1|Outcome|Bi-homonal Bionic Pancreas|"Closed-loop blood glucose control with a bi-hormonal bionic endocrine pancreas designed by Edward Damiano and Firas El-Khatib of Boston University. The device will deliver insulin lispro (Humalog) and glucagon based on blood glucose levels estimated by a continuous glucose monitoring device (Dexcom G4 Platinum) and a proprietary dosing algorithm. Blood glucose control will be automated for 5 days during which volunteers will sleep in a hotel and roam freely in downtown Boston during the day. There will be no restrictions on diet or exercise.~Bi-homonal Bionic Pancreas: A computer algorithm will automatically deliver insulin lispro and glucagon based on the signal from a minimally invasive continuous glucose monitor."
147488|NCT01762059|O1|Outcome|Bionic Pancreas|
147489|NCT01762059|O1|Outcome|Bionic Pancreas|Closed loop blood glucose control using a bihormonal bionic endocrine pancreas delivering insulin and glucagon using continuous glucose monitor readings, with doses calculated by a computer algorithm every 5 minutes .
147490|NCT01762059|E1|Reported Event|Bionic Pancreas (Closed Loop)|
147491|NCT01761747|B1|Baseline|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
147492|NCT01761747|P1|Participant Flow|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
147493|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
147494|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
147495|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
147496|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
147497|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
147498|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
147499|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
147500|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
147501|NCT01761747|E1|Reported Event|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
147502|NCT01761565|B1|Baseline|One Dose of SUF NT 15 mcg Then 40 Doses of SUF NT 15 mcg|"Arm 1/Period 1: Single dose of SUF NT 15 mcg~Single dose of SUF NT 15 mcg~Arm 2/Period 2: 40 consecutive doses of SUF NT 15 mcg~40 consecutive doses of SUF NT 15 mcg"
147503|NCT01761565|P1|Participant Flow|Single Dose of SUF NT 15 mcg Then 40 Doses of SUF NT 15mcg|"Arm 1/Period 1: Single dose of SUF NT 15 mcg~Subjects received oral naltrexone 50 mg approximately 14 and 2 hours before and 10 hours after the SUF NT dosing~Arm 2/Period 2: 40 consecutive doses of SUF NT 15 mcg~Subjects received oral naltrexone 50 mg approximately 2 hours before and 10, 22, and 34 hours after the first dose of SUF NT in Period 2."
147504|NCT01761565|O2|Outcome|40 Consecutive Doses of SUF NT 15 mcg|
147523|NCT01761279|E1|Reported Event|HDWL + I-Scan|High Definition White Light Endoscopy and i-Scan assessment performed of all polyps
147524|NCT01761175|B3|Baseline|Total|Total of all reporting groups
147525|NCT01761175|B2|Baseline|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block~Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
147526|NCT01761175|B1|Baseline|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block~Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery."
147527|NCT01761175|P2|Participant Flow|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block~Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
147528|NCT01761175|P1|Participant Flow|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block~Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery."
147529|NCT01761175|O2|Outcome|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block~Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
147530|NCT01761175|O1|Outcome|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block~Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected looking for a crescent shape distribution around the artery."
147531|NCT01761175|O2|Outcome|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block~Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
147532|NCT01761175|O1|Outcome|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block~Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected looking for a crescent shape distribution around the artery."
147533|NCT01761175|O2|Outcome|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block~Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
147534|NCT01761175|O1|Outcome|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block~Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected looking for a crescent shape distribution around the artery."
147535|NCT01761175|O2|Outcome|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block~Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
147536|NCT01761175|O1|Outcome|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block~Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery."
147537|NCT01761175|O2|Outcome|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block~Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
147538|NCT01761175|O1|Outcome|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block~Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery."
147539|NCT01761175|O2|Outcome|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block~Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
147540|NCT01761175|O1|Outcome|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block~Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery."
147541|NCT01761175|O2|Outcome|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block~Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
147542|NCT01761175|O1|Outcome|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block~Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery."
147543|NCT01761175|O2|Outcome|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block~Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
147544|NCT01761175|O1|Outcome|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block~Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery."
147545|NCT01761175|O2|Outcome|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block~Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
147546|NCT01761175|O1|Outcome|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block~Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery."
147547|NCT01761175|O2|Outcome|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block~Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
147548|NCT01761175|O1|Outcome|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block~Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery."
147549|NCT01761175|O2|Outcome|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block~Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
147550|NCT01761175|O1|Outcome|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block~Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected looking for a crescent shape distribution around the artery."
147551|NCT01761175|O2|Outcome|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block~Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
147552|NCT01761175|O1|Outcome|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block~Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery."
147553|NCT01761175|E2|Reported Event|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block~Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
147554|NCT01761175|E1|Reported Event|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block~Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery."
147555|NCT01761162|B1|Baseline|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
147556|NCT01761162|P1|Participant Flow|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
147557|NCT01761162|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
147558|NCT01761162|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
147559|NCT01761162|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
147560|NCT01761162|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
147561|NCT01761162|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
147562|NCT01761162|E1|Reported Event|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
147563|NCT01761019|B1|Baseline|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
147564|NCT01761019|P1|Participant Flow|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
147565|NCT01761019|O1|Outcome|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
147566|NCT01761019|O1|Outcome|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
147567|NCT01761019|O1|Outcome|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
147568|NCT01761019|O1|Outcome|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
147569|NCT01761019|O1|Outcome|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
147570|NCT01761019|E1|Reported Event|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
147571|NCT01760993|B1|Baseline|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
147572|NCT01760993|P1|Participant Flow|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
147573|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
147574|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
147575|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
147576|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
147577|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
147578|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
147579|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
147580|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
147581|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
147582|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
147583|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
147584|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
147585|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
147586|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
147587|NCT01760993|E1|Reported Event|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
147588|NCT01760941|B1|Baseline|Radiotherapy|"Single fraction radiotherapy~Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.~planning."
147589|NCT01760941|P1|Participant Flow|Radiotherapy|"Single fraction radiotherapy~Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.~planning."
147590|NCT01760941|O1|Outcome|Radiotherapy|"Single fraction radiotherapy~Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.~planning."
147591|NCT01760941|O1|Outcome|Radiotherapy|"Single fraction radiotherapy~Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.~planning."
147592|NCT01760941|O1|Outcome|Radiotherapy|"Single fraction radiotherapy~Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.~planning."
147593|NCT01760941|O1|Outcome|Radiotherapy|"Single fraction radiotherapy~Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.~planning."
147594|NCT01760941|E1|Reported Event|Radiotherapy|"Single fraction radiotherapy~Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.~planning."
147595|NCT01760889|B4|Baseline|Total|Total of all reporting groups
147596|NCT01760889|B3|Baseline|Placebo|Placebo: One capsule a day for 26 weeks
147597|NCT01760889|B2|Baseline|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
147598|NCT01760889|B1|Baseline|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
147600|NCT01760889|P2|Participant Flow|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
147601|NCT01760889|P1|Participant Flow|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
147602|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
147603|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
147604|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
147605|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
147606|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
147607|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
147608|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
147609|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
147610|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
147611|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
147612|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
147613|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
147614|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
147615|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
147616|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
147617|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
147618|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
147674|NCT01760473|O6|Outcome|Bup/Nal 16/4|"Intranasal challenge drug: 16 mg of Buprenorphine administered intranasally with 4 mg of Naloxone.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
164939|NCT01694108|O2|Outcome|Control Children|No intervention
147619|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
147620|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
147621|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
147622|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
147623|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
147624|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
147625|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
147626|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
147627|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
147628|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
147629|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
147630|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
147631|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
147632|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
147633|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
147634|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
147635|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
147636|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
147637|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
147638|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
147675|NCT01760473|O5|Outcome|Bup/Nal 8/16|"Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 16 mg of Naloxone.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
151896|NCT01739335|O1|Outcome|Mifepristone (600 mg/Day)|600 mg/day mifepristone for one week
147639|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
147640|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
147641|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
147642|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
147643|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
147644|NCT01760889|E3|Reported Event|Placebo|Placebo: One capsule a day for 26 weeks
147645|NCT01760889|E2|Reported Event|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
147646|NCT01760889|E1|Reported Event|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
147647|NCT01760876|B1|Baseline|Biofreedom Stent|Coronary intervention: The BioFreedom drug coated study stent (DCS) is a polymer-free abluminally coated Biolimus A9 coated drug stent. 100 patients needed to complete 3 OCT assessments over 9 months:- (1) at baseline (n = 100) for best stent optimization, (2) at 5 monthly groups (randomly assigned in 1 to 5 months n= 20:20:20:20:20) for early healing profile, and (3) at 9 months (n = 100) for neointima metrics.
147648|NCT01760876|P1|Participant Flow|Biofreedom Stent|Coronary intervention: The BioFreedom drug coated study stent (DCS) is a polymer-free biolimus A9 coated drug stent. 100 patients needed to complete 3 OCT assessments over 9 months:- (1) at baseline (n = 100) for best stent optimization, (2) at 5 monthly groups (randomly assigned in 1 to 5 months n= 20:20:20:20:20) for early healing profile, and (3) at 9 months (n = 100) for neointima metrics.
147649|NCT01760876|O1|Outcome|Biofreedom Stent|The healing profile (curve) in terms of percentage strut coverage of the BioFreedom Stent increased from a median of 85.77%, 86.95%, 88.56%, 96.79%, and 97.14% in the first 5 months, to 99.55% at 9 months.
147650|NCT01760876|E1|Reported Event|Biofreedom Stent|The BioFreedom drug coated study stent (DCS) is a polymer-free abluminally coated Biolimus A9 coated drug stent. 100 patients needed to complete 3 OCT assessments over 9 months:- (1) at baseline (n = 100) for best stent optimization, (2) at 5 monthly groups (randomly assigned in 1 to 5 months n= 20:20:20:20:20) for early healing profile, and (3) at 9 months (n = 100) for neointima metrics.
147651|NCT01760785|B3|Baseline|Total|Total of all reporting groups
147652|NCT01760785|B2|Baseline|Sugar Pill|Placebo: Doses will be titrated over the first four days of study in the same manner as the active study drug. After titration, the research pharmacy may increase the dose by 1 tablet per day, in the same fashion that the active drug may be adjusted, so that the participant and clinical team remain blinded to the drug assignment. The research pharmacy may also reduce the daily dosage back down by one tablet per day for the same reason.
147653|NCT01760785|B1|Baseline|Divalproex Sodium|Divalproex sodium: Doses will be given in 250mg increments and titrated over the first four days of study until a starting dose of 750 mg is reached. The Study Oversight Team, who is not involved in any clinical visits, will be un-blinded to study drug assignment and will have plasma concentration results and adverse event reports available to them. If a subject has no adverse events and is not at therapeutic level as indicated by the blood levels, the Study Oversight Team may inform the research pharmacy to increase the dose by 1 tablet of 250 mg to 1000 mg per day. The Study Oversight Team may also inform the research pharmacy to reduce the daily dosage back down to 750 mg per day if plasma concentrations or adverse events become intolerable. The maximum dose for the purpose of this study will be 1250 mg daily and the minimum dose will be 750 mg daily. Subjects who cannot tolerate the minimum dose will be excluded from any further study participation.
147654|NCT01760785|P2|Participant Flow|Sugar Pill|Placebo: Doses will be titrated over the first four days of study in the same manner as the active study drug. After titration, the research pharmacy may increase the dose by 1 tablet per day, in the same fashion that the active drug may be adjusted, so that the participant and clinical team remain blinded to the drug assignment. The research pharmacy may also reduce the daily dosage back down by one tablet per day for the same reason.
147676|NCT01760473|O4|Outcome|Bup/Nal 8/8|"Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 8 mg of Naloxone.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
147677|NCT01760473|O3|Outcome|Bup/Nal 8/2|"Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 2 mg of Naloxone.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
151897|NCT01739335|O2|Outcome|Sugar Pill|Placebo (sugar pill) for one week
147655|NCT01760785|P1|Participant Flow|Divalproex Sodium|Divalproex sodium: Doses will be given in 250mg increments and titrated over the first four days of study until a starting dose of 750 mg is reached. The Study Oversight Team, who is not involved in any clinical visits, will be un-blinded to study drug assignment and will have plasma concentration results and adverse event reports available to them. If a subject has no adverse events and is not at therapeutic level as indicated by the blood levels, the Study Oversight Team may inform the research pharmacy to increase the dose by 1 tablet of 250 mg to 1000 mg per day. The Study Oversight Team may also inform the research pharmacy to reduce the daily dosage back down to 750 mg per day if plasma concentrations or adverse events become intolerable. The maximum dose for the purpose of this study will be 1250 mg daily and the minimum dose will be 750 mg daily. Subjects who cannot tolerate the minimum dose will be excluded from any further study participation.
147656|NCT01760785|O2|Outcome|Sugar Pill|Placebo: Doses will be titrated over the first four days of study in the same manner as the active study drug. After titration, the research pharmacy may increase the dose by 1 tablet per day, in the same fashion that the active drug may be adjusted, so that the participant and clinical team remain blinded to the drug assignment. The research pharmacy may also reduce the daily dosage back down by one tablet per day for the same reason.
147657|NCT01760785|O1|Outcome|Divalproex Sodium|Divalproex sodium: Doses will be given in 250mg increments and titrated over the first four days of study until a starting dose of 750 mg is reached. The Study Oversight Team, who is not involved in any clinical visits, will be un-blinded to study drug assignment and will have plasma concentration results and adverse event reports available to them. If a subject has no adverse events and is not at therapeutic level as indicated by the blood levels, the Study Oversight Team may inform the research pharmacy to increase the dose by 1 tablet of 250 mg to 1000 mg per day. The Study Oversight Team may also inform the research pharmacy to reduce the daily dosage back down to 750 mg per day if plasma concentrations or adverse events become intolerable. The maximum dose for the purpose of this study will be 1250 mg daily and the minimum dose will be 750 mg daily. Subjects who cannot tolerate the minimum dose will be excluded from any further study participation.
147658|NCT01760785|E2|Reported Event|Sugar Pill|Placebo: Doses will be titrated over the first four days of study in the same manner as the active study drug. After titration, the research pharmacy may increase the dose by 1 tablet per day, in the same fashion that the active drug may be adjusted, so that the participant and clinical team remain blinded to the drug assignment. The research pharmacy may also reduce the daily dosage back down by one tablet per day for the same reason.
147659|NCT01760785|E1|Reported Event|Divalproex Sodium|Divalproex sodium: Doses will be given in 250mg increments and titrated over the first four days of study until a starting dose of 750 mg is reached. The Study Oversight Team, who is not involved in any clinical visits, will be un-blinded to study drug assignment and will have plasma concentration results and adverse event reports available to them. If a subject has no adverse events and is not at therapeutic level as indicated by the blood levels, the Study Oversight Team may inform the research pharmacy to increase the dose by 1 tablet of 250 mg to 1000 mg per day. The Study Oversight Team may also inform the research pharmacy to reduce the daily dosage back down to 750 mg per day if plasma concentrations or adverse events become intolerable. The maximum dose for the purpose of this study will be 1250 mg daily and the minimum dose will be 750 mg daily. Subjects who cannot tolerate the minimum dose will be excluded from any further study participation.
147660|NCT01760473|B1|Baseline|Intranasal Challege Drug|Each of the 9 experimental challenge drugs were administered intranasally to all participants in random order.
147661|NCT01760473|P1|Participant Flow|Intranasal Challege Drug|Each of the 9 experimental challenge drugs were administered intranasally to all participants in random order. This study employed a Latin-square randomization procedure, therefore, the testing order of the 9 IN doses was unique for each participant.
147662|NCT01760473|O9|Outcome|Naloxone 4 mg|"Intranasal challenge drug: Intranasal Naloxone 4mg.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
147663|NCT01760473|O8|Outcome|Placebo|"Intranasal challenge drug: Intranasal lactose powder.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
147664|NCT01760473|O7|Outcome|Heroin|"Intranasal challenge drug: 24 mg of heroin administered intranasally.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
147665|NCT01760473|O6|Outcome|Bup/Nal 16/4|"Intranasal challenge drug: 16 mg of Buprenorphine administered intranasally with 4 mg of Naloxone.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
147666|NCT01760473|O5|Outcome|Bup/Nal 8/16|"Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 16 mg of Naloxone.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
147667|NCT01760473|O4|Outcome|Bup/Nal 8/8|"Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 8 mg of Naloxone.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
147668|NCT01760473|O3|Outcome|Bup/Nal 8/2|"Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 2 mg of Naloxone.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
147669|NCT01760473|O2|Outcome|Bup 16|"Intranasal challenge drug: 16 mg of Buprenorphine administered intranasally.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
147670|NCT01760473|O1|Outcome|Bup 8|"Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
147671|NCT01760473|O9|Outcome|Naloxone 4 mg|"Intranasal challenge drug: Intranasal Naloxone 4mg.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
147672|NCT01760473|O8|Outcome|Placebo|"Intranasal challenge drug: Intranasal lactose powder.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
147673|NCT01760473|O7|Outcome|Heroin|"Intranasal challenge drug: 24 mg of heroin administered intranasally.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
147678|NCT01760473|O2|Outcome|Bup 16|"Intranasal challenge drug: 16 mg of Buprenorphine administered intranasally.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
147679|NCT01760473|O1|Outcome|Bup 8|"Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally.~Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order."
147680|NCT01760473|E1|Reported Event|Intranasal Challege Drug|Each of the 9 experimental challenge drugs were administered intranasally to all participants in a randomized order. Therefore, the testing sequence for each of the participants was unique. Although we assessed for some averse events on a daily basis, other measures of health (e.g., blood chemistry) were assessed on a weekly basis. As multiple doses were tested during the week, therefore, in some cases we cannot causally connect some AEs to any individual drug/testing condition.
147681|NCT01760304|B3|Baseline|Total|Total of all reporting groups
147682|NCT01760304|B2|Baseline|Placebo First, Then Budesonide/Formoterol|"Subjects received in a blinded fashion placebo 2 inhalation then Budesonide/Formoterol (Symbicort ® )2 inhalations (160/4.5)~Subject will have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs Placebo on visit 1 then Budesonide/formoterol (B/F) 160/4.5 msg per activation on visit 2 (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
147683|NCT01760304|B1|Baseline|Budesonide / Formoterol First , Then Placebo|"Subjects received in a blinded fashion Budesonide/Formoterol (Symbicort ® )2 inhalations (160/4.5) then placebo 2 inhalations Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.~Subject will have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
147684|NCT01760304|P2|Participant Flow|Placebo Then Budesonide/Formoterol|"Every patient in this arm received in a blinded fashion placebo first then Budesonide/Formoterol (Symbicort ® )~Placebo: Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
147685|NCT01760304|P1|Participant Flow|Budesonide / Formoterol , Then Placebo|"This is a crossover study, where every patient signed to this arm received in a blinded fashion Budesonide/Formoterol (Symbicort ® ) 160/4.5 mcg (2 inhalations) then placebo~Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.~Subject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
147686|NCT01760304|O2|Outcome|Placebo|"This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo~Placebo: Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
147687|NCT01760304|O1|Outcome|Budesonide / Formoterol|"This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo~Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.~Subject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of either Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
147688|NCT01760304|O2|Outcome|Placebo|"In this arm patients will received in a blinded fashion placebo first then Budesonide/Formoterol (Symbicort ® ) on subsequent visit (cross-over study)~Placebo: Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
147689|NCT01760304|O1|Outcome|Budesonide / Formoterol|"In this arm patients received in a blinded fashion Budesonide/Formoterol (Symbicort ® ) first then placebo on subsequent visit (cross-over study)~Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.~Subject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of either Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
147690|NCT01760304|O2|Outcome|Placebo|"In this arm patients received in a blinded fashion placebo first then Budesonide/Formoterol (Symbicort ® ) on subsequent visit (cross-over study).~Placebo: On visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
147691|NCT01760304|O1|Outcome|Budesonide / Formoterol|"In this arm patients received in a blinded fashion Budesonide/Formoterol (Symbicort ® ) first then placebo on subsequent visit (cross-over study)~Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.~Subject who met inclusion criteria will have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
147692|NCT01760304|E2|Reported Event|Placebo|"This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo~Placebo: Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
147693|NCT01760304|E1|Reported Event|Budesonide / Formoterol|"This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo~Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.~Subject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of either Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
164940|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
147694|NCT01759602|B1|Baseline|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
147695|NCT01759602|P1|Participant Flow|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
147696|NCT01759602|O1|Outcome|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
147697|NCT01759602|O1|Outcome|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
147698|NCT01759602|O1|Outcome|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
147699|NCT01759602|O1|Outcome|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
147700|NCT01759602|O1|Outcome|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
147701|NCT01759602|E1|Reported Event|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
147702|NCT01759511|B1|Baseline|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
147703|NCT01759511|P1|Participant Flow|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
147704|NCT01759511|O1|Outcome|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
147705|NCT01759511|O1|Outcome|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
147706|NCT01759511|O1|Outcome|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
147707|NCT01759511|O1|Outcome|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
147708|NCT01759511|O1|Outcome|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
147709|NCT01759511|E1|Reported Event|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
147710|NCT01759420|B1|Baseline|IV Ondansetron|"Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.~Ondansetron: 4mg of intravenous ondansetron"
147711|NCT01759420|P1|Participant Flow|IV Ondansetron|"Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.~Ondansetron: 4mg of intravenous ondansetron"
147712|NCT01759420|O1|Outcome|IV Ondansetron|"Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.~Ondansetron: 4mg of intravenous ondansetron"
147713|NCT01759420|O1|Outcome|IV Ondansetron|"Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.~Ondansetron: 4mg of intravenous ondansetron"
147714|NCT01759420|E1|Reported Event|IV Ondansetron|"Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.~Ondansetron: 4mg of intravenous ondansetron"
147715|NCT01759407|B3|Baseline|Total|Total of all reporting groups
147716|NCT01759407|B2|Baseline|Standard Anesthetic Management|
147717|NCT01759407|B1|Baseline|Femoral Nerve Block|"Ropivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg~Ropivicaine"
147718|NCT01759407|P2|Participant Flow|Standard Anesthetic Management|
164941|NCT01694108|O2|Outcome|Control Children|No intervention
147719|NCT01759407|P1|Participant Flow|Femoral Nerve Block|"Ropivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg~Ropivicaine"
147720|NCT01759407|O2|Outcome|Standard Anesthetic Management|
147721|NCT01759407|O1|Outcome|Femoral Nerve Block|"Ropivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg~Ropivicaine"
147722|NCT01759407|O2|Outcome|Standard Anesthetic Management|
147723|NCT01759407|O1|Outcome|Femoral Nerve Block|"Ropivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg~Ropivicaine"
147724|NCT01759407|O2|Outcome|Standard Anesthetic Management|
147725|NCT01759407|O1|Outcome|Femoral Nerve Block|"Ropivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg~Ropivicaine"
147726|NCT01759407|E2|Reported Event|Standard Anesthetic Management|
147727|NCT01759407|E1|Reported Event|Femoral Nerve Block|"Ropivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg~Ropivicaine"
147728|NCT01759381|B3|Baseline|Total|Total of all reporting groups
147729|NCT01759381|B2|Baseline|NPWT Arm Therapy|"This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.~Negative pressure wound therapy (NPWT)"
147730|NCT01759381|B1|Baseline|No Negative Pressure Wound Therapy Device|This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.
147731|NCT01759381|P2|Participant Flow|NPWT Arm Therapy|"This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.~Negative pressure wound therapy (NPWT)"
147732|NCT01759381|P1|Participant Flow|No Negative Pressure Wound Therapy Device|This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.
147733|NCT01759381|O2|Outcome|NPWT Arm Therapy|"This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.~Negative pressure wound therapy (NPWT)"
147734|NCT01759381|O1|Outcome|No Negative Pressure Wound Therapy Device|This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.
147735|NCT01759381|E2|Reported Event|NPWT Arm Therapy|"This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.~Negative pressure wound therapy (NPWT)"
147736|NCT01759381|E1|Reported Event|No Negative Pressure Wound Therapy Device|This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.
147737|NCT01759368|B3|Baseline|Total|Total of all reporting groups
147738|NCT01759368|B2|Baseline|Control Group|Control group received usual care that includes multidisciplinary care approach in which patients receive guidance and support for self-care. In the care of HF patients, the cardiac team plays a central role in monitoring and interpreting patient symptoms, optimizing medication and providing education. The cardiac team consists of two physicians, one specialized heart failure nurse and a physiotherapist who helps after a hospitalization period. As part of the care process, patients capable of carrying out self-care are identified and they are encouraged to regularly measure their blood pressure, heart rate and weight at home. So far, the information exchange between heart failure patients and care personnel has taken place during patients' visits to the clinic and by telephone. Systematic collection and exploitation of the self-measurement data has been difficult, since it depends on the patient's own activity.
147739|NCT01759368|B1|Baseline|Telemonitoring-assisted Self-care|Telemonitoring group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. The measurements taken at home to be uploaded were: diastolic and systolic blood pressure, pulse, body weight and an assessment of symptoms. The symptom assessment concerned the patient's feelings of dizziness, dyspnea, palpitation, weakness and, oedema. Patients were also asked to evaluate their overall condition- whether their condition had deteriorated, improved or remained unchanged. The patients were advised to carry out and report the measurements together with the self-assessment once a week. The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not mak
147740|NCT01759368|P2|Participant Flow|Control Group|Control group received multidisciplinary care that was standard.
147741|NCT01759368|P1|Participant Flow|Telemonitoring Assisted Self-care|Telemonitoring group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. The measurements taken at home to be uploaded were: diastolic and systolic blood pressure, pulse, body weight and an assessment of symptoms. The symptom assessment concerned the patient's feelings of dizziness, dyspnea, palpitation, weakness and, oedema. Patients were also asked to evaluate their overall condition- whether their condition had deteriorated, improved or remained unchanged. The patients were advised to carry out and report the measurements together with the self-assessment once a week. The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring.
147742|NCT01759368|O2|Outcome|Control Group|Control group received usual care
147804|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147805|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147806|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147807|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147808|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147743|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.~Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
147744|NCT01759368|O2|Outcome|Control Group|Control group received usual care that includes multidisciplinary care approach in which patients receive guidance and support for self-care. In the care of HF patients, the cardiac team plays a central role in monitoring and interpreting patient symptoms, optimizing medication and providing education. The cardiac team consists of two physicians, one specialized heart failure nurse and a physiotherapist who helps after a hospitalization period. As part of the care process, patients capable of carrying out self-care are identified and they are encouraged to regularly measure their blood pressure, heart rate and weight at home. So far, the information exchange between heart failure patients and care personnel has taken place during patients’ visits to the clinic and by telephone. Systematic collection and exploitation of the self-measurement data has been difficult, since it depends on the patient’s own activity
147745|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|Telemonitoring group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. The measurements taken at home to be uploaded were: diastolic and systolic blood pressure, pulse, body weight and an assessment of symptoms. The symptom assessment concerned the patient's feelings of dizziness, dyspnea, palpitation, weakness and, oedema. Patients were also asked to evaluate their overall condition- whether their condition had deteriorated, improved or remained unchanged. The patients were advised to carry out and report the measurements together with the self-assessment once a week. The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring.
147746|NCT01759368|O2|Outcome|Control Group|Control group received usual care
147747|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.~Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
147748|NCT01759368|O2|Outcome|Control Group|Control group received usual care
147749|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.~Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
147750|NCT01759368|O2|Outcome|Control Group|Control group received usual care
147751|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.~Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
147752|NCT01759368|O2|Outcome|Control Group|Control group received usual care
147753|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.~Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
147754|NCT01759368|O2|Outcome|Control Group|Control group received usual care
147755|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.~Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
147756|NCT01759368|E2|Reported Event|Control Group|Control group received usual care
147809|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147757|NCT01759368|E1|Reported Event|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.~Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
147758|NCT01759290|B1|Baseline|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147759|NCT01759290|P1|Participant Flow|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147760|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147761|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147762|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147763|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147764|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147765|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147766|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147767|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147768|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147769|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147770|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147771|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147772|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147773|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147774|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147775|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147776|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147777|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147778|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147779|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147780|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147781|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147782|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147783|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147784|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147785|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147786|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147787|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147788|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147789|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147790|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147791|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147792|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147793|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147794|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147795|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147796|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147797|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147798|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147799|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147800|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147801|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147802|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147803|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147810|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147811|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147812|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147813|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147814|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147815|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147816|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147817|NCT01759290|E1|Reported Event|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
147818|NCT01759264|B1|Baseline|Moderate-to-severe Crohn's Disease|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
147819|NCT01759264|P1|Participant Flow|Moderate-to-severe Crohn's Disease|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
147820|NCT01759264|O2|Outcome|Moderate-to-severe Crohn's Disease (PP Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
147821|NCT01759264|O1|Outcome|Moderate-to-severe Crohn's Disease (ITT Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
147822|NCT01759264|O2|Outcome|Moderate-to-severe Crohn's Disease (PP Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
147823|NCT01759264|O1|Outcome|Moderate-to-severe Crohn's Disease (ITT Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
147824|NCT01759264|O2|Outcome|Moderate-to-severe Crohn's Disease (PP Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
147825|NCT01759264|O1|Outcome|Moderate-to-severe Crohn's Disease (ITT Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
147826|NCT01759264|O2|Outcome|Moderate-to-severe Crohn's Disease (PP Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
147827|NCT01759264|O1|Outcome|Moderate-to-severe Crohn's Disease (ITT Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
147828|NCT01759264|O2|Outcome|Moderate-to-severe Crohn's Disease (PP Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
147829|NCT01759264|O1|Outcome|Moderate-to-severe Crohn's Disease (ITT Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
147830|NCT01759264|E1|Reported Event|Moderate-to-severe Crohn's Disease|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
147831|NCT01759251|B1|Baseline|Vestibular Vertigo|Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe betahistine dihydrochloride at dose 48 mg/day in accordance with locally approved label
147832|NCT01759251|P1|Participant Flow|Vestibular Vertigo|Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe betahistine dihydrochloride at dose 48 mg/day in accordance with locally approved label
147833|NCT01759251|O1|Outcome|Vestibular Vertigo|Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe betahistine dihydrochloride at dose 48 mg/day in accordance with locally approved label
147834|NCT01759251|E1|Reported Event|Vestibular Vertigo|Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe betahistine dihydrochloride at dose 48 mg/day in accordance with locally approved label
147835|NCT01759160|B3|Baseline|Total|Total of all reporting groups
147836|NCT01759160|B2|Baseline|Schnider|Plasma TCI in Schnider Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
147837|NCT01759160|B1|Baseline|Marsh|Plasma TCI in Marsh Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
147838|NCT01759160|P2|Participant Flow|Schnider|Plasma TCI in Schnider Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
147839|NCT01759160|P1|Participant Flow|Marsh|Plasma TCI in Marsh Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
147840|NCT01759160|O2|Outcome|Schnider|Plasma TCI in Schnider Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
147841|NCT01759160|O1|Outcome|Marsh|Plasma TCI in Marsh Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
147842|NCT01759160|E2|Reported Event|Schnider|Plasma TCI in Schnider Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
147843|NCT01759160|E1|Reported Event|Marsh|Plasma TCI in Marsh Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
147844|NCT01758900|B3|Baseline|Total|Total of all reporting groups
147845|NCT01758900|B2|Baseline|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
147846|NCT01758900|B1|Baseline|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
147847|NCT01758900|P2|Participant Flow|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
147848|NCT01758900|P1|Participant Flow|CO2(Carbon Dioxide) Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE(single-balloon enteroscopy)."
164942|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
147849|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
147850|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
147851|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
147852|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
147853|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
147854|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
147855|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
147856|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
147857|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
147858|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
147859|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
147860|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
147861|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
147862|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
147863|NCT01758900|E2|Reported Event|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
147864|NCT01758900|E1|Reported Event|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
147865|NCT01758289|B1|Baseline|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
147866|NCT01758289|P1|Participant Flow|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol intravenous (IV) per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
147867|NCT01758289|O2|Outcome|Paricalcitol IV: Week 24|Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
147868|NCT01758289|O1|Outcome|Paricalcitol IV: Baseline|Baseline Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
147869|NCT01758289|O3|Outcome|Paricalcitol IV: Week 24|Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
147870|NCT01758289|O2|Outcome|Paricalcitol IV: Week 12|Week 12 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
147943|NCT01757691|O1|Outcome|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
147871|NCT01758289|O1|Outcome|Paricalcitol IV: Baseline|Baseline Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
147872|NCT01758289|O3|Outcome|Paricalcitol IV: Week 24|Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
147873|NCT01758289|O2|Outcome|Paricalcitol IV: Week 12|Week 12 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
147874|NCT01758289|O1|Outcome|Paricalcitol IV: Baseline|Baseline Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
147875|NCT01758289|O1|Outcome|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
147876|NCT01758289|O1|Outcome|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
147877|NCT01758289|O3|Outcome|Paricalcitol IV: Week 24|Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
147878|NCT01758289|O2|Outcome|Paricalcitol IV: Week 12|Week 12 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
147879|NCT01758289|O1|Outcome|Paricalcitol IV: Baseline|Baseline Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
147880|NCT01758289|O1|Outcome|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
147881|NCT01758289|E1|Reported Event|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
147882|NCT01757964|B3|Baseline|Total|Total of all reporting groups
147883|NCT01757964|B2|Baseline|Bacteriotherapy: Ulcerative Colitis|Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit.
147884|NCT01757964|B1|Baseline|Bacteriotherapy: Crohn's Disease|Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit.
147885|NCT01757964|P2|Participant Flow|Bacteriotherapy: Ulcerative Colitis|Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit.
147886|NCT01757964|P1|Participant Flow|Bacteriotherapy: Crohn's Disease|Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit.
147887|NCT01757964|O1|Outcome|Bacteriotherapy|"Study stool recipient's will receive approximately 30 grams of processed donor stool through a tube into their stomach for the transplant.~Bacteriotherapy"
147944|NCT01757691|O2|Outcome|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
147945|NCT01757691|O1|Outcome|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
147946|NCT01757691|E2|Reported Event|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
147888|NCT01757964|E1|Reported Event|Bacteriotherapy|Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit.
147889|NCT01757847|B3|Baseline|Total|Total of all reporting groups
147890|NCT01757847|B2|Baseline|Acceptance and Commitment Therapy (ACT)|The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
147891|NCT01757847|B1|Baseline|Brief MOVE-II Active Control Group Intervention|The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy
147892|NCT01757847|P2|Participant Flow|Acceptance and Commitment Therapy (ACT)|The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
147893|NCT01757847|P1|Participant Flow|Brief MOVE-II Active Control Group Intervention|The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy.
147894|NCT01757847|O2|Outcome|Acceptance and Commitment Therapy (ACT)|The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
147895|NCT01757847|O1|Outcome|Brief MOVE-II Active Control Group Intervention|The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy.
147896|NCT01757847|O2|Outcome|Acceptance and Commitment Therapy (ACT)|The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
147897|NCT01757847|O1|Outcome|Brief MOVE-II Active Control Group Intervention|The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy.
147898|NCT01757847|E2|Reported Event|Acceptance and Commitment Therapy (ACT)|The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
147947|NCT01757691|E1|Reported Event|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
147948|NCT01757678|B1|Baseline|Standard of Care: FFR and ICA|"Single arm~Measured FFR (Fractional Flow Reserve) and ICA (Invasive Coronary Angiography)"
147949|NCT01757678|P1|Participant Flow|Standard of Care: FFR and ICA|"Single arm~Measured FFR: Fractional Flow Reserve"
147899|NCT01757847|E1|Reported Event|Brief MOVE-II Active Control Group Intervention|The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy.
147900|NCT01757821|B1|Baseline|Real 6-Hz Priming Sham 6-Hz Priming Real 1-Hz rTMS Only|"real 6-Hz primed low-frequency rTMS~real 6-Hz primed low-frequency rTMS:~Sham 6-Hz Primed low-frequency rTMS~real 1-Hz rTMS only"
147901|NCT01757821|P1|Participant Flow|6-Hz Priming|"real 6-Hz primed low-frequency rTMS~real 6-Hz primed low-frequency rTMS: 10 minutes of 6-Hz stimulation (real priming) followed by 10 minutes of 1-Hz low-frequency stimulation delivered to the nonstroke primary motor region~Sham 6-Hz Primed low-frequency rTMS~real 1-Hz rTMS only~real 1-Hz rTMS only: 20 minutes of low-frequency rTMS delivered to the nonstroke primary motor region~Sham 6-Hz Primed low-frequency rTMS: 10 minutes of sham priming stimulation followed by 10 minutes of 1-Hz low-frequency stimulation delivered to the nonstroke primary motor region"
147902|NCT01757821|O3|Outcome|Real 1-Hz rTMS Only|"real 1-Hz rTMS only~real 1-Hz rTMS only: 20 minutes of low-frequency rTMS delivered to the nonstroke primary motor region"
147903|NCT01757821|O2|Outcome|Sham 6-Hz Priming|"Sham 6-Hz Primed low-frequency rTMS~Sham 6-Hz Primed low-frequency rTMS: 10 minutes of sham priming stimulation followed by 10 minutes of 1-Hz low-frequency stimulation delivered to the nonstroke primary motor region"
147904|NCT01757821|O1|Outcome|Real 6-Hz Priming|"real 6-Hz primed low-frequency rTMS~real 6-Hz primed low-frequency rTMS: 10 minutes of 6-Hz stimulation (real priming) followed by 10 minutes of 1-Hz low-frequency stimulation delivered to the nonstroke primary motor region"
147905|NCT01757821|E3|Reported Event|Real 1-Hz rTMS Only|"real 1-Hz rTMS only~real 1-Hz rTMS only: 20 minutes of low-frequency rTMS delivered to the nonstroke primary motor region"
147906|NCT01757821|E2|Reported Event|Sham 6-Hz Priming|"Sham 6-Hz Primed low-frequency rTMS~Sham 6-Hz Primed low-frequency rTMS: 10 minutes of sham priming stimulation followed by 10 minutes of 1-Hz low-frequency stimulation delivered to the nonstroke primary motor region"
147907|NCT01757821|E1|Reported Event|Real 6-Hz Priming|"real 6-Hz primed low-frequency rTMS~real 6-Hz primed low-frequency rTMS: 10 minutes of 6-Hz stimulation (real priming) followed by 10 minutes of 1-Hz low-frequency stimulation delivered to the nonstroke primary motor region"
147908|NCT01757717|B1|Baseline|Ir-192 High Dose Rate (HDR)|"This pilot study is an investigation into the use of Ir-192 high dose rate (HDR) afterloader-based brachytherapy with catheter placement using image-guided surgical navigation techniques for patients with painful/symptomatic metastatic or recurrent lesions in the spine and/or pelvis that have been maximally treated with external beam radiation therapy.~Ir-192 high dose rate (HDR): Patients will be followed at 2 months (+/- 2 weeks) post-treatment and then approximately every 3 months (+/- 2 weeks) until approximately 11 months of follow up. They will be evaluated for pain referable to the treated site, clinical and radiographic evidence of local progression, and treatment related toxicity. Thereafter, patients will be followed as clinically indicated."
147909|NCT01757717|P1|Participant Flow|Ir-192 High Dose Rate (HDR)|"This pilot study is an investigation into the use of Ir-192 high dose rate (HDR) afterloader-based brachytherapy with catheter placement using image-guided surgical navigation techniques for patients with painful/symptomatic metastatic or recurrent lesions in the spine and/or pelvis that have been maximally treated with external beam radiation therapy.~Ir-192 high dose rate (HDR): Patients will be followed at 2 months (+/- 2 weeks) post-treatment and then approximately every 3 months (+/- 2 weeks) until approximately 11 months of follow up. They will be evaluated for pain referable to the treated site, clinical and radiographic evidence of local progression, and treatment related toxicity. Thereafter, patients will be followed as clinically indicated."
147910|NCT01757717|O1|Outcome|Ir-192 High Dose Rate (HDR)|"This pilot study is an investigation into the use of Ir-192 high dose rate (HDR) afterloader-based brachytherapy with catheter placement using image-guided surgical navigation techniques for patients with painful/symptomatic metastatic or recurrent lesions in the spine and/or pelvis that have been maximally treated with external beam radiation therapy.~Ir-192 high dose rate (HDR): Patients will be followed at 2 months (+/- 2 weeks) post-treatment and then approximately every 3 months (+/- 2 weeks) until approximately 11 months of follow up. They will be evaluated for pain referable to the treated site, clinical and radiographic evidence of local progression, and treatment related toxicity. Thereafter, patients will be followed as clinically indicated."
147911|NCT01757717|O1|Outcome|Ir-192 High Dose Rate (HDR)|"This pilot study is an investigation into the use of Ir-192 high dose rate (HDR) afterloader-based brachytherapy with catheter placement using image-guided surgical navigation techniques for patients with painful/symptomatic metastatic or recurrent lesions in the spine and/or pelvis that have been maximally treated with external beam radiation therapy.~Ir-192 high dose rate (HDR): Patients will be followed at 2 months (+/- 2 weeks) post-treatment and then approximately every 3 months (+/- 2 weeks) until approximately 11 months of follow up. They will be evaluated for pain referable to the treated site, clinical and radiographic evidence of local progression, and treatment related toxicity. Thereafter, patients will be followed as clinically indicated."
147912|NCT01757717|E1|Reported Event|Ir-192 High Dose Rate (HDR)|"This pilot study is an investigation into the use of Ir-192 high dose rate (HDR) afterloader-based brachytherapy with catheter placement using image-guided surgical navigation techniques for patients with painful/symptomatic metastatic or recurrent lesions in the spine and/or pelvis that have been maximally treated with external beam radiation therapy.~Ir-192 high dose rate (HDR): Patients will be followed at 2 months (+/- 2 weeks) post-treatment and then approximately every 3 months (+/- 2 weeks) until approximately 11 months of follow up. They will be evaluated for pain referable to the treated site, clinical and radiographic evidence of local progression, and treatment related toxicity. Thereafter, patients will be followed as clinically indicated."
147913|NCT01757704|B3|Baseline|Total|Total of all reporting groups
147950|NCT01757678|O1|Outcome|Standard of Care: FFR and ICA|(ICA) Invasive coronary angiography with (FFR) fractional flow reserve measurement in standard of care environment.
148397|NCT01754922|O1|Outcome|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
147914|NCT01757704|B2|Baseline|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
147915|NCT01757704|B1|Baseline|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
147916|NCT01757704|P2|Participant Flow|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
147917|NCT01757704|P1|Participant Flow|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
147918|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
147919|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
147920|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
147951|NCT01757678|O1|Outcome|Standard of Care: FFR and ICA|(ICA) Invasive coronary angiography with (FFR) fractional flow reserve measurement in standard of care environment.
147952|NCT01757678|O1|Outcome|Standard of Care: FFR and ICA|(ICA) Invasive coronary angiography with (FFR) fractional flow reserve measurement in standard of care environment.
147921|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
147922|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
147923|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
147924|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
147925|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
147926|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
147927|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
147953|NCT01757678|O2|Outcome|cCTA vs. FFR|
147954|NCT01757678|O1|Outcome|FFRct vs. FFR|
147955|NCT01757678|O2|Outcome|cCTA vs. FFR|
147956|NCT01757678|O1|Outcome|FFRct vs. FFR|
148398|NCT01754922|O2|Outcome|Control|OEF/OIF/OND Veterans deployed to regions other than Southwest Asia
147928|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
147929|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
147930|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
147931|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
147932|NCT01757704|E2|Reported Event|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
147933|NCT01757704|E1|Reported Event|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
147934|NCT01757691|B1|Baseline|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
147935|NCT01757691|P2|Participant Flow|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
147936|NCT01757691|P1|Participant Flow|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
147937|NCT01757691|O1|Outcome|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
147938|NCT01757691|O2|Outcome|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
147939|NCT01757691|O1|Outcome|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
147940|NCT01757691|O2|Outcome|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
147941|NCT01757691|O1|Outcome|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
147942|NCT01757691|O2|Outcome|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
164943|NCT01694108|O2|Outcome|Control Children|No intervention
147957|NCT01757678|E3|Reported Event|Standard of Care: FFR (Fractional Flow Reserve)|(FFR) Fractional flow reserve in standard of care environment.
147958|NCT01757678|E2|Reported Event|Standard of Care: cCTA (Coronary Computed Tomography Angio)|(cCTA) Coronary computed tomography angiography in standard of care environment.
147959|NCT01757678|E1|Reported Event|Standard of Care: ICA (Invasive Coronary Angiography)|(ICA) Invasive coronary angiography in standard of care environment.
147960|NCT01757561|B5|Baseline|Total|Total of all reporting groups
147961|NCT01757561|B4|Baseline|Sevoflurane-Normal|"patients with preoperative SjvO2≥55%~sevoflurane: use inhalation anesthesia with sevoflurane"
147962|NCT01757561|B3|Baseline|Sevoflurane-Abnormal|"patients with preoperative SjvO2<55%~sevoflurane: use inhalation anesthesia with sevoflurane"
147963|NCT01757561|B2|Baseline|Propofol-Normal|"patients with preoperative SjvO2≥55%~propofol: use total intravenous anesthesia with propofol"
147964|NCT01757561|B1|Baseline|Propofol-Abnormal|"patients with preoperative SjvO2<55%~propofol: use total intravenous anesthesia with propofol"
147965|NCT01757561|P4|Participant Flow|Sevoflurane-Normal|"patients with preoperative SjvO2≥55%~sevoflurane: use inhalation anesthesia with sevoflurane"
147966|NCT01757561|P3|Participant Flow|Sevoflurane-Abnormal|"patients with preoperative SjvO2<55%~sevoflurane: use inhalation anesthesia with sevoflurane"
147967|NCT01757561|P2|Participant Flow|Propofol-Normal|"patients with preoperative SjvO2≥55%~propofol: use total intravenous anesthesia with propofol"
147968|NCT01757561|P1|Participant Flow|Propofol-Abnormal|"patients with preoperative SjvO2<55%~propofol: use total intravenous anesthesia with propofol"
147969|NCT01757561|O4|Outcome|Sevoflurane-Normal|"patients with preoperative SjvO2≥55%~sevoflurane: use inhalation anesthesia with sevoflurane"
147970|NCT01757561|O3|Outcome|Sevoflurane-Abnormal|"patients with preoperative SjvO2<55%~sevoflurane: use inhalation anesthesia with sevoflurane"
147971|NCT01757561|O2|Outcome|Propofol-Normal|"patients with preoperative SjvO2≥55%~propofol: use total intravenous anesthesia with propofol"
147972|NCT01757561|O1|Outcome|Propofol-Abnormal|"patients with preoperative SjvO2<55%~propofol: use total intravenous anesthesia with propofol"
147973|NCT01757561|O4|Outcome|Sevoflurane-Normal|"patients with preoperative SjvO2≥55%~sevoflurane: use inhalation anesthesia with sevoflurane"
147974|NCT01757561|O3|Outcome|Sevoflurane-Abnormal|"patients with preoperative SjvO2<55%~sevoflurane: use inhalation anesthesia with sevoflurane"
147975|NCT01757561|O2|Outcome|Propofol-Normal|"patients with preoperative SjvO2≥55%~propofol: use total intravenous anesthesia with propofol"
147976|NCT01757561|O1|Outcome|Propofol-Abnormal|"patients with preoperative SjvO2<55%~propofol: use total intravenous anesthesia with propofol"
147977|NCT01757561|E4|Reported Event|Sevoflurane-Normal|"patients with preoperative SjvO2≥55%~sevoflurane: use inhalation anesthesia with sevoflurane"
147978|NCT01757561|E3|Reported Event|Sevoflurane-Abnormal|"patients with preoperative SjvO2<55%~sevoflurane: use inhalation anesthesia with sevoflurane"
147979|NCT01757561|E2|Reported Event|Propofol-Normal|"patients with preoperative SjvO2≥55%~propofol: use total intravenous anesthesia with propofol"
147980|NCT01757561|E1|Reported Event|Propofol-Abnormal|"patients with preoperative SjvO2<55%~propofol: use total intravenous anesthesia with propofol"
147981|NCT01757405|B3|Baseline|Total|Total of all reporting groups
147982|NCT01757405|B2|Baseline|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
147983|NCT01757405|B1|Baseline|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
147984|NCT01757405|P2|Participant Flow|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
147985|NCT01757405|P1|Participant Flow|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
147986|NCT01757405|O2|Outcome|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
147987|NCT01757405|O1|Outcome|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
147988|NCT01757405|O2|Outcome|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
147989|NCT01757405|O1|Outcome|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
147990|NCT01757405|O2|Outcome|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
147991|NCT01757405|O1|Outcome|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
147992|NCT01757405|O2|Outcome|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
147993|NCT01757405|O1|Outcome|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
147994|NCT01757405|O2|Outcome|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
147995|NCT01757405|O1|Outcome|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
148395|NCT01754922|P1|Participant Flow|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
147996|NCT01757405|O2|Outcome|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
147997|NCT01757405|O1|Outcome|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
147998|NCT01757405|E2|Reported Event|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
147999|NCT01757405|E1|Reported Event|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) every 3 hours as on-demand intravenous bolus infusions.
148000|NCT01757275|B3|Baseline|Total|Total of all reporting groups
148001|NCT01757275|B2|Baseline|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
148002|NCT01757275|B1|Baseline|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
148003|NCT01757275|P2|Participant Flow|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
148004|NCT01757275|P1|Participant Flow|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
148005|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
148006|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
148007|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
148008|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
148009|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
148010|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
148011|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
148012|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
148013|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
148014|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
148015|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
148016|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
148017|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
148018|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
148019|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
148020|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
148021|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
148022|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
148023|NCT01757275|E2|Reported Event|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
148024|NCT01757275|E1|Reported Event|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
148025|NCT01757197|B1|Baseline|All Patients|"Toclizumab will be administered on Day 0. The administration of tocilizumab will be every 2 weeks for a total of 8 doses.~Toclizumab: 8 mg/kg IV, once every 1-2 weeks. The maximum dose per infusion should not exceed 800 mg."
148026|NCT01757197|P1|Participant Flow|All Patients|"Toclizumab will be administered on Day 0. The administration of tocilizumab will be every 2 weeks for a total of 8 doses.~Toclizumab: 8 mg/kg IV, once every 1-2 weeks. The maximum dose per infusion should not exceed 800 mg."
148027|NCT01757197|O1|Outcome|All Patients|"Toclizumab will be administered on Day 0. The administration of tocilizumab will be every 2 weeks for a total of 8 doses.~Toclizumab: 8 mg/kg IV, once every 1-2 weeks. The maximum dose per infusion should not exceed 800 mg."
148028|NCT01757197|O1|Outcome|All Patients|"Toclizumab will be administered on Day 0. The administration of tocilizumab will be every 2 weeks for a total of 8 doses.~Toclizumab: 8 mg/kg IV, once every 1-2 weeks. The maximum dose per infusion should not exceed 800 mg."
148068|NCT01757171|E2|Reported Event|Arm B (Prior Taxane Therapy)|"Subject previously treated with taxane. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks~Cabazitaxel: 20mg IV over 1 hour every 3 weeks"
148029|NCT01757197|E1|Reported Event|All Patients|"Toclizumab will be administered on Day 0. The administration of tocilizumab will be every 2 weeks for a total of 8 doses.~Toclizumab: 8 mg/kg IV, once every 1-2 weeks. The maximum dose per infusion should not exceed 800 mg."
148030|NCT01757184|B3|Baseline|Total|Total of all reporting groups
148031|NCT01757184|B2|Baseline|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
148032|NCT01757184|B1|Baseline|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
148033|NCT01757184|P2|Participant Flow|Double-Blind Placebo Followed by Open-Label SA|Double-blind Period: IV infusions of placebo administered once every other week (qow); Open-Label Period: IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered qow. In the event of disease progression (based on protocol-defined criteria), subjects could be considered for a dose increase to 3 mg/kg qow during the open-label period.
148034|NCT01757184|P1|Participant Flow|Double-blind SA, Followed by Open-Label SA|Double-blind Period: IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow); Open-Label Period: IV infusions of SA at a dose of 1 mg/kg administered qow. In the event of disease progression (based on protocol-defined criteria), subjects could be considered for a dose increase to 3 mg/kg qow during the open-label period.
148035|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
148036|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
148037|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
148038|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
148039|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
148040|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
148041|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
148042|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
148043|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
148044|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
148045|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
148046|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
148047|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
148048|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
148049|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
148050|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
148051|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
148052|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
148053|NCT01757184|E2|Reported Event|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
148054|NCT01757184|E1|Reported Event|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
148055|NCT01757171|B3|Baseline|Total|Total of all reporting groups
148056|NCT01757171|B2|Baseline|Arm B (Prior Taxane Therapy)|"Subject previously treated with taxane. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks~Cabazitaxel: 20mg IV over 1 hour every 3 weeks"
148057|NCT01757171|B1|Baseline|Arm A (Taxane naïve)|"No prior Taxane treatment. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks~Cabazitaxel: 20mg IV over 1 hour every 3 weeks"
148058|NCT01757171|P2|Participant Flow|Arm B (Prior Taxane Therapy)|Arm B - Subject previously treated with taxane. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks Cabazitaxel: 20mg IV over 1 hour every 3 weeks
148059|NCT01757171|P1|Participant Flow|Arm A (Taxane naïve)|Arm A - No prior Taxane treatment. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks Cabazitaxel: 20mg IV over 1 hour every 3 weeks
148060|NCT01757171|O2|Outcome|Arm B (Prior Taxane Therapy)|"Subject previously treated with taxane. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks~Cabazitaxel: 20mg IV over 1 hour every 3 weeks"
148061|NCT01757171|O1|Outcome|Arm A (Taxane naïve)|"No prior Taxane treatment. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks~Cabazitaxel: 20mg IV over 1 hour every 3 weeks"
148062|NCT01757171|O2|Outcome|Arm B (Prior Taxane Therapy)|"Subject previously treated with taxane. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks~Cabazitaxel: 20mg IV over 1 hour every 3 weeks"
148063|NCT01757171|O1|Outcome|Arm A (Taxane naïve)|"No prior Taxane treatment. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks~Cabazitaxel: 20mg IV over 1 hour every 3 weeks"
148064|NCT01757171|O2|Outcome|Arm B (Prior Taxane Therapy)|"Subject previously treated with taxane. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks~Cabazitaxel: 20mg IV over 1 hour every 3 weeks"
148065|NCT01757171|O1|Outcome|Arm A (Taxane naïve)|"No prior Taxane treatment. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks~Cabazitaxel: 20mg IV over 1 hour every 3 weeks"
148066|NCT01757171|O2|Outcome|Arm B (Prior Taxane Therapy)|"Subject previously treated with taxane. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks~Cabazitaxel: 20mg IV over 1 hour every 3 weeks"
148067|NCT01757171|O1|Outcome|Arm A (Taxane naïve)|"No prior Taxane treatment. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks~Cabazitaxel: 20mg IV over 1 hour every 3 weeks"
164944|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
148069|NCT01757171|E1|Reported Event|Arm A (Taxane naïve)|"No prior Taxane treatment. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks~Cabazitaxel: 20mg IV over 1 hour every 3 weeks"
148070|NCT01756976|B3|Baseline|Total|Total of all reporting groups
148071|NCT01756976|B2|Baseline|Control Group|The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention.
148072|NCT01756976|B1|Baseline|Investigational Device|The 510k cleared OrthoPAT Advance will be used in this standard of care arm.
148073|NCT01756976|P2|Participant Flow|Control Group|The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention.
148074|NCT01756976|P1|Participant Flow|Investigational Device|The 510k cleared OrthoPAT Advance will be used in this standard of care arm.
148075|NCT01756976|O2|Outcome|Control Group|The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention.
148076|NCT01756976|O1|Outcome|Investigational Device|The 510k cleared OrthoPAT Advance will be used in this standard of care arm.
148077|NCT01756976|E2|Reported Event|Control Group|The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention.
148078|NCT01756976|E1|Reported Event|Investigational Device|The 510k cleared OrthoPAT Advance will be used in this standard of care arm.
148079|NCT01756586|B3|Baseline|Total|Total of all reporting groups
148080|NCT01756586|B2|Baseline|Experimental|"Bupivacaine with Dexamethasone~Dexamethasone~Bupivacaine: Control"
148081|NCT01756586|B1|Baseline|Control|"Plain bupivacaine~Bupivacaine: Control"
148082|NCT01756586|P2|Participant Flow|Experimental|"Bupivacaine with Dexamethasone~Dexamethasone~Bupivacaine: Control"
148083|NCT01756586|P1|Participant Flow|Control|"Plain bupivacaine~Bupivacaine: Control"
148084|NCT01756586|O2|Outcome|Experimental|"Bupivacaine with Dexamethasone~Dexamethasone~Bupivacaine: Control"
148085|NCT01756586|O1|Outcome|Control|"Plain bupivacaine~Bupivacaine: Control"
148086|NCT01756586|E2|Reported Event|Experimental|"Bupivacaine with Dexamethasone~Dexamethasone~Bupivacaine: Control"
148087|NCT01756586|E1|Reported Event|Control|"Plain bupivacaine~Bupivacaine: Control"
148088|NCT01756391|B1|Baseline|Observational Cohort|students with asthma grades K-8 after the spring screening attending schools where permission for sampling obtained
148089|NCT01756391|P1|Participant Flow|Observational Cohort|students with asthma grades K-8 after the spring screening attending schools where permission for sampling obtained
148090|NCT01756391|O1|Outcome|Observational Cohort|students with asthma grades K-8 after the spring screening attending schools where permission for sampling obtained
148091|NCT01756391|E1|Reported Event|Observational Cohort|students with asthma grades K-8 after the spring screening attending schools where permission for sampling obtained
148092|NCT01756300|B1|Baseline|Renal Sympathetic Denervation|Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.
148093|NCT01756300|P1|Participant Flow|Renal Sympathetic Denervation|Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with severe resistant hypertension.
148094|NCT01756300|O4|Outcome|AT Twelve Month|Subjects achieved at least 10 mmHg systolic blood pressure reduction from Baseline at Twelve month post-procedure
148095|NCT01756300|O3|Outcome|At Six Month|Subjects achieved at least 10 mmHg systolic blood pressure reduction from Baseline at six month post-procedure
148096|NCT01756300|O2|Outcome|At Three Month|Subjects achieved at least 10 mmHg systolic blood pressure reduction from Baseline at three month post-procedure
148097|NCT01756300|O1|Outcome|At One Month|Subjects achieved at least 10 mmHg systolic blood pressure reduction from Baseline at one month post-procedure
148098|NCT01756300|O4|Outcome|At Twelve Month|Subjects achieved target systolic blood pressure, i.e., less than 140 mmHg, at twelve month post-procedure
148099|NCT01756300|O3|Outcome|At Six Month|Subjects achieved target systolic blood pressure, i.e., less than 140 mmHg, at six month post-procedure
148100|NCT01756300|O2|Outcome|At Three Month|Subjects achieved target systolic blood pressure, i.e., less than 140 mmHg, at three month post-procedure
148101|NCT01756300|O1|Outcome|At One Month|Subjects achieved target systolic blood pressure, i.e., less than 140 mmHg, at one month post-procedure
148102|NCT01756300|O4|Outcome|Blood Pressures at 12-Month Follow Up|ABPM blood pressures measured at 12-month post procedure
148103|NCT01756300|O3|Outcome|Blood Pressures at 6-Month Follow Up|ABPM blood pressures measured at 6-month post procedure
148104|NCT01756300|O2|Outcome|Blood Pressures at 3-Month Follow Up|ABPM blood pressures measured at 3-month post procedure
148105|NCT01756300|O1|Outcome|Blood Pressures at Baseline|ABPM blood pressures measured at Baseline
148106|NCT01756300|O5|Outcome|Blood Pressures at 12-Month Follow Up|Office blood pressures measured at 12-month post procedure
148107|NCT01756300|O4|Outcome|Blood Pressures at 6-Month Follow Up|Office blood pressures measured at 6-month post procedure
148108|NCT01756300|O3|Outcome|Blood Pressures at 3-Month Follow Up|Office blood pressures measured at 3-month post procedure
148109|NCT01756300|O2|Outcome|Blood Pressures at 1-Month Follow Up|Office blood pressures measured at one month post-procedure
148110|NCT01756300|O1|Outcome|Blood Pressures at Baseline|Office blood pressures measured at Baseline
148111|NCT01756300|O1|Outcome|Renal Sympathetic Denervation|Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.
148112|NCT01756300|O1|Outcome|Renal Sympathetic Denervation|Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.
148396|NCT01754922|O2|Outcome|Control|OEF/OIF/OND Veterans deployed to regions other than Southwest Asia
148113|NCT01756300|E1|Reported Event|Renal Sympathetic Denervation|Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.
148114|NCT01756274|B1|Baseline|Neonates 'Left-over' Blood Samples|Blood samples used in this study are 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS. Each subject could contribute up to 2 blood samples. Baseline Characteristics for Participant Flow based on number of blood samples, not number of subjects.
148115|NCT01756274|P1|Participant Flow|Neonates 'Left-over' Blood Samples|Blood samples used in this study are 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS.
148116|NCT01756274|O1|Outcome|Neonates 'Left-over' Blood Samples|Blood samples used in this study were 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS. Each subject could contribute up to 2 blood samples.
148117|NCT01756274|O1|Outcome|Neonates 'Left-over' Blood Samples|Blood samples used in this study were'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS. Each subject could contribute up to 2 blood samples.
148118|NCT01756274|O1|Outcome|Neonates 'Left-over' Blood Samples|Blood samples used in this study were'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS. Each subject could contribute up to 2 blood samples.
148119|NCT01756274|O1|Outcome|Neonates 'Left-over' Blood Samples|Blood samples used in this study were 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS. Each subject could contribute up to 2 blood samples.
148120|NCT01756274|E1|Reported Event|Neonates 'Left-over' Blood Samples|Blood samples used in this study are 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory.
148121|NCT01756235|B1|Baseline|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
148122|NCT01756235|P1|Participant Flow|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice
148123|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
148124|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
148125|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
148126|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
148127|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
148128|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
148129|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
148130|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
148131|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
148132|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
148133|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
148134|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
148135|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
148136|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
148137|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
148138|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
148139|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
148140|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
148141|NCT01756235|E1|Reported Event|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
148142|NCT01756157|B1|Baseline|Entire Study Population|Included participants who received 1000 U CINRYZE with 24,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks (Treatment A) first and 2000 U CINRYZE with 48,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks (Treatment B) first.
148191|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
148192|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
148143|NCT01756157|P2|Participant Flow|Treatment Sequence B/A|"Participants received Treatment B in Period 1 and Treatment A in Period 2; for 8 weeks each as a single 20 mL SC injection per dose. A washout period of at least 7 days and no more than 30 days was maintained between the last dose in Period 1 and the first dose in Period 2.~Treatment B: 2000 U CINRYZE with 48,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks.~Treatment A: 1000 U CINRYZE with 24,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks."
148144|NCT01756157|P1|Participant Flow|Treatment Sequence A/B|"Participants received Treatment A in Period 1 and Treatment B in Period 2; for 8 weeks each as a single 20 milliliter (mL) subcutaneous (SC) injection per dose. A washout period of at least 7 days and no more than 30 days was maintained between the last dose in Period 1 and the first dose in Period 2.~Treatment A: 1000 U CINRYZE with 24,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks.~Treatment B: 2000 U CINRYZE with 48,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks."
148145|NCT01756157|O2|Outcome|Treatment B (2000 U CINRYZE + 48000 U rHuPH20)|Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
148146|NCT01756157|O1|Outcome|Treatment A (1000 U CINRYZE + 24000 U rHuPH20)|Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
148147|NCT01756157|O2|Outcome|Treatment B (2000 U CINRYZE + 48000 U rHuPH20)|Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
148148|NCT01756157|O1|Outcome|Treatment A (1000 U CINRYZE + 24000 U rHuPH20)|Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
148149|NCT01756157|O2|Outcome|Treatment B (2000 U CINRYZE + 48000 U rHuPH20)|Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
148150|NCT01756157|O1|Outcome|Treatment A (1000 U CINRYZE + 24000 U rHuPH20)|Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
148151|NCT01756157|O2|Outcome|Treatment B (2000 U CINRYZE + 48000 U rHuPH20)|Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
148152|NCT01756157|O1|Outcome|Treatment A (1000 U CINRYZE + 24000 U rHuPH20)|Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
148153|NCT01756157|O2|Outcome|Treatment B (2000 U CINRYZE + 48000 U rHuPH20)|Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
148154|NCT01756157|O1|Outcome|Treatment A (1000 U CINRYZE + 24000 U rHuPH20)|Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
148155|NCT01756157|E2|Reported Event|Treatment B (2000 U CINRYZE + 48000 U rHuPH20)|Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
148156|NCT01756157|E1|Reported Event|Treatment A (1000 U CINRYZE + 24000 U rHuPH20)|Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
148157|NCT01756079|B1|Baseline|Overall Participants|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
148158|NCT01756079|P1|Participant Flow|Overall Participants|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
148159|NCT01756079|O1|Outcome|Overall Participants|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day).
148160|NCT01756079|O1|Outcome|Overall Participants|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day).
148161|NCT01756079|O1|Outcome|Overall Participants|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
148193|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
151898|NCT01739335|O1|Outcome|Mifepristone (600 mg/Day)|600 mg/day mifepristone for one week
148162|NCT01756079|E1|Reported Event|Overall Participants: Lead-in, Treatment and Follow-up|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
148163|NCT01756053|B1|Baseline|All Study Subjects|Subjects who were randomized and received their Period 1 study medication (ABT-089 or matching placebo).
148164|NCT01756053|P2|Participant Flow|Placebo, Then ABT-089|"Those randomized to placebo (matching ABT-089 10 mg capsules) during study medication period 1 will take four capsules daily during a 10-day medication period. After a washout period of ~21 days, these subjects will then take four 10 mg capsules (40 mg) daily of ABT-089 for a second 10-day study medication period.~Placebo: Matching placebo capsules supplied by study drug supplier."
148165|NCT01756053|P1|Participant Flow|ABT-089, Then Placebo|"Those randomized to active ABT-089 during study medication period 1 will take four 10mg capsules daily (40mg daily) during a 10-day medication period. After a washout period of ~21 days, these subjects will then take four capsules of matching placebo daily for a second 10-day medication period.~ABT-089: Selective neuronal nicotinic receptor agonist."
148166|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
148167|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
148168|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
148169|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
148170|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
148171|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
148172|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
148173|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
148174|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
148175|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
148176|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
148177|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
148178|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
148179|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
148180|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
148181|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
148182|NCT01756053|E2|Reported Event|Placebo|"Subjects were assigned to take four placebo capsules (matching ABT-089 10 mg) daily during a 10-day medication period.~Placebo: Matched placebo capsules supplied by study drug supplier."
148183|NCT01756053|E1|Reported Event|ABT-089|"Subjects were assigned to take four 10 mg capsules daily (40 mg daily) during a 10-day medication period.~ABT-089: Selective neuronal nicotinic receptor agonist."
148184|NCT01755702|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline measures.
148185|NCT01755702|P1|Participant Flow|Overall|"In this cross-over study, participants were randomly-assigned to a blinded treatment sequence. Each participant was expected to complete 1, 2, or 3 periods depending on number of headache episodes.~The following treatments were administered during the study.~1000/130mg paracetamol/caffeine (two 500/65mg caplets) plus placebo ibuprofen (two caplets) for a total of four caplets taken orally with approximately (approx.) 250 ml of water.~1000mg paracetamol (two 500mg caplets) plus placebo paracetamol/caffeine (two caplets) taken orally with approx. 250 ml of water.~400mg ibuprofen (two 200mg caplets) plus placebo paracetamol/caffeine (two caplets) for a total of four caplets taken orally with approx. 250 ml of water.~placebo paracetamol/caffeine (two caplets) plus placebo ibuprofen (two caplets) for a total of four caplets taken orally with approx. 250 ml of water."
148186|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
148187|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
148188|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
148189|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
148190|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
148194|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
148195|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
148196|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
148197|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
148198|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
148199|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
148200|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
148201|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
148202|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
148203|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
148204|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
148205|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
148206|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
148207|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
148208|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
148209|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
148210|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
148211|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
148212|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
148213|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
148214|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
148215|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
148216|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
148217|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
148218|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
148219|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
148220|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
148221|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
148222|NCT01755702|E4|Reported Event|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
148223|NCT01755702|E3|Reported Event|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
148224|NCT01755702|E2|Reported Event|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
148225|NCT01755702|E1|Reported Event|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
148226|NCT01755637|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline measures
148391|NCT01754922|B3|Baseline|Total|Total of all reporting groups
148392|NCT01754922|B2|Baseline|Control|Veterans deployed to regions other than Iraq or Afghanistan or non-deployed
148227|NCT01755637|P2|Participant Flow|Albendazole (Alcohol) First, Then Albendazole (Aqua)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment followed by 400 mg aqua based albendazole tablets. A wash-out period of 7 days was maintained between treatment periods.
148228|NCT01755637|P1|Participant Flow|Albendazole (Aqua) First, Then Albendazole (Alcohol)|Participants were orally administered with 400 milligram (mg) Albendazole tablets manufactured under aqua based solvent condition as single dose treatment, followed by single dose treatment of 400 mg albendazole tablets manufactured under ethanol based solvent conditions. A wash-out period of 7 days was maintained between treatment periods.
148229|NCT01755637|O2|Outcome|Reference: Albendazole Sulphoxide Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole Sulphoxide tablets manufactured under ethanol based solvent condition as single dose treatment.
148230|NCT01755637|O1|Outcome|Experimental: Albendazole Sulphoxide Tablet (Aqua Based)|Participants were orally administered with 400 milligram (mg) Albendazole Sulphoxide tablets manufactured under aqua based solvent condition as single dose treatment.
148231|NCT01755637|O2|Outcome|Reference: Albendazole Sulphoxide Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole sulphoxide tablets manufactured under ethanol based solvent condition as single dose treatment.
148232|NCT01755637|O1|Outcome|Experimental: Albendazole Sulphoxide Tablet (Aqua Based)|Participants were orally administered with 400 mg Albendazole sulphoxide tablets manufactured under aqua based solvent condition as single dose treatment.
148233|NCT01755637|O2|Outcome|Reference: Albendazole Sulphoxide Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole sulphoxide tablets manufactured under ethanol based solvent condition as single dose treatment.
148234|NCT01755637|O1|Outcome|Experimental: Albendazole Sulphoxide Tablet (Aqua Based)|Participants were orally administered with 400 milligram (mg) Albendazole sulphoxide tablets manufactured under aqua based solvent condition as single dose treatment.
148235|NCT01755637|O2|Outcome|Reference: Albendazole Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
148236|NCT01755637|O1|Outcome|Experimental: Albendazole Tablet (Aqua Based)|Participants were orally administered with 400 milligram (mg) Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.
148237|NCT01755637|O2|Outcome|Reference: Albendazole Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
148238|NCT01755637|O1|Outcome|Experimental: Albendazole Tablet (Aqua Based)|Participants were orally administered with 400 milligram (mg) Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.
148239|NCT01755637|O2|Outcome|Reference: Albendazole Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
148240|NCT01755637|O1|Outcome|Experimental: Albendazole Tablet (Aqua Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.
148241|NCT01755637|O2|Outcome|Reference: Albendazole Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
148242|NCT01755637|O1|Outcome|Experimental: Albendazole Tablet (Aqua Based)|Participants were orally administered with 400 milligram (mg) Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.
148243|NCT01755637|E2|Reported Event|Albendazole Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
148244|NCT01755637|E1|Reported Event|Albendazole Tablet (Aqua Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.
148245|NCT01755455|B1|Baseline|All Study Participants|Includes those who started the study with First Intervention and those who started the study with Second Intervention
148246|NCT01755455|P2|Participant Flow|Ferrous Sulfate, Then Placebo|Ferrous Sulfate 325 mg administered daily for 6 weeks followed by 4-week washout, then Placebo administered daily for 6 weeks.
148247|NCT01755455|P1|Participant Flow|Placebo, Then Ferrous Sulfate|Placebo administered daily for 6 week followed by 4-week washout, then Ferrous Sulfate 325 mg administered daily for 6 weeks.
148248|NCT01755455|O2|Outcome|Ferrous Sulfate|Outcome measure in all participants who received ferrous sulfate.
148249|NCT01755455|O1|Outcome|Placebo|Outcome measure in all participants who received placebo.
148250|NCT01755455|O2|Outcome|Ferrous Sulfate|Outcome measure in all participants who received ferrous sulfate.
148251|NCT01755455|O1|Outcome|Placebo|Outcome measure in all participants who received placebo.
148252|NCT01755455|O2|Outcome|Ferrous Sulfate|Outcome measure in all participants who received ferrous sulfate.
148253|NCT01755455|O1|Outcome|Placebo|Outcome measure in all participants who received placebo.
148254|NCT01755455|O2|Outcome|Ferrous Sulfate|Outcome measure in all participants who received ferrous sulfate.
148255|NCT01755455|O1|Outcome|Placebo|Outcome measure in all participants who received placebo.
148256|NCT01755455|E2|Reported Event|Ferrous Sulfate|Events observed among all participants while they were receiving ferrous sulfate.
148257|NCT01755455|E1|Reported Event|Placebo|Events observed among all participants while they were receiving placebo.
148258|NCT01755234|B3|Baseline|Total|Total of all reporting groups
148259|NCT01755234|B2|Baseline|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60~Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
148260|NCT01755234|B1|Baseline|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)~Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
148393|NCT01754922|B1|Baseline|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
148261|NCT01755234|P2|Participant Flow|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60~Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
148262|NCT01755234|P1|Participant Flow|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)~Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
148263|NCT01755234|O2|Outcome|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60~Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
148264|NCT01755234|O1|Outcome|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)~Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
148265|NCT01755234|O2|Outcome|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60~Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
148266|NCT01755234|O1|Outcome|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)~Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
148267|NCT01755234|O2|Outcome|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60~Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
148268|NCT01755234|O1|Outcome|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)~Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
148269|NCT01755234|O2|Outcome|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60~Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
148270|NCT01755234|O1|Outcome|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)~Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
148271|NCT01755234|E2|Reported Event|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60~Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
148272|NCT01755234|E1|Reported Event|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)~Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
148273|NCT01755169|B5|Baseline|Total|Total of all reporting groups
148274|NCT01755169|B4|Baseline|Placebo|Placebo
148275|NCT01755169|B3|Baseline|Ketamine 1 mg/kg/Dose|"A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
148276|NCT01755169|B2|Baseline|Ketamine 0.5 mg/kg/Dose|"A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
148277|NCT01755169|B1|Baseline|Ketamine 0.25 mg/kg/Dose|"A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
148278|NCT01755169|P4|Participant Flow|Placebo|Placebo
148279|NCT01755169|P3|Participant Flow|Ketamine 1 mg/kg/Dose|"A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
148280|NCT01755169|P2|Participant Flow|Ketamine 0.5 mg/kg/Dose|"A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
148281|NCT01755169|P1|Participant Flow|Ketamine 0.25 mg/kg/Dose|"A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
148282|NCT01755169|O4|Outcome|Placebo|Placebo
148283|NCT01755169|O3|Outcome|Ketamine 1 mg/kg/Dose|"A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
148284|NCT01755169|O2|Outcome|Ketamine 0.5 mg/kg/Dose|"A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
148285|NCT01755169|O1|Outcome|Ketamine 0.25 mg/kg/Dose|"A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
148286|NCT01755169|E4|Reported Event|Placebo|Placebo
148287|NCT01755169|E3|Reported Event|Ketamine 1 mg/kg/Dose|"A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
148288|NCT01755169|E2|Reported Event|Ketamine 0.5 mg/kg/Dose|"A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
148394|NCT01754922|P2|Participant Flow|Control|OEF/OIF/OND Veterans deployed to regions other than Southwest Asia
151899|NCT01739335|O2|Outcome|Sugar Pill|Placebo (sugar pill) for one week
148289|NCT01755169|E1|Reported Event|Ketamine 0.25 mg/kg/Dose|"A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
148290|NCT01755156|B3|Baseline|Total|Total of all reporting groups
148291|NCT01755156|B2|Baseline|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
148292|NCT01755156|B1|Baseline|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
148293|NCT01755156|P2|Participant Flow|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
148294|NCT01755156|P1|Participant Flow|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
148295|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
148296|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
148297|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
148298|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
148299|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
148300|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
148301|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
148302|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
148303|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
148304|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
148305|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
148306|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
148307|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
148308|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
148309|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
148310|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
148311|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
148312|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
148313|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
148314|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
148315|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
148316|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
148317|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
148318|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
148319|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
148320|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
148321|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
148322|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
148323|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
148324|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
148325|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
148326|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
148327|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
148328|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
148329|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
148330|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
148331|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
148332|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
148333|NCT01755156|E4|Reported Event|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
148334|NCT01755156|E3|Reported Event|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
148335|NCT01755156|E2|Reported Event|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks.
148336|NCT01755156|E1|Reported Event|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
148337|NCT01755143|B3|Baseline|Total|Total of all reporting groups
148338|NCT01755143|B2|Baseline|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.~Pacemaker System"
148339|NCT01755143|B1|Baseline|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
148340|NCT01755143|P2|Participant Flow|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.~Pacemaker System"
148341|NCT01755143|P1|Participant Flow|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
148342|NCT01755143|O2|Outcome|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.~Pacemaker System"
148343|NCT01755143|O1|Outcome|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
148344|NCT01755143|O1|Outcome|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
148345|NCT01755143|O2|Outcome|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.~Pacemaker System"
148346|NCT01755143|O1|Outcome|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
148347|NCT01755143|O2|Outcome|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.~Pacemaker System"
148348|NCT01755143|O1|Outcome|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
148349|NCT01755143|O2|Outcome|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.~Pacemaker System"
148350|NCT01755143|O1|Outcome|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
148351|NCT01755143|O1|Outcome|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
148352|NCT01755143|E2|Reported Event|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.~Pacemaker System"
148353|NCT01755143|E1|Reported Event|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
148354|NCT01755091|B4|Baseline|Total|Total of all reporting groups
148355|NCT01755091|B3|Baseline|10 mg/Day|"Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation~Dronabinol"
148356|NCT01755091|B2|Baseline|2.5 mg/Day|"Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in~Dronabinol"
148357|NCT01755091|B1|Baseline|Sugar Pill|"Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in~Placebo (for Dronabinol)"
148358|NCT01755091|P3|Participant Flow|10 mg/Day|"Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation~Dronabinol"
148359|NCT01755091|P2|Participant Flow|2.5 mg/Day|"Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in~Dronabinol"
148360|NCT01755091|P1|Participant Flow|Sugar Pill|"Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in~Placebo (for Dronabinol)"
148361|NCT01755091|O3|Outcome|10 mg/Day|"Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation~Dronabinol"
148362|NCT01755091|O2|Outcome|2.5 mg/Day|"Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in~Dronabinol"
148363|NCT01755091|O1|Outcome|Sugar Pill|"Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in~Placebo (for Dronabinol)"
148364|NCT01755091|O3|Outcome|10 mg/Day|"Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation~Dronabinol"
148365|NCT01755091|O2|Outcome|2.5 mg/Day|"Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in~Dronabinol"
148366|NCT01755091|O1|Outcome|Sugar Pill|"Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in~Placebo (for Dronabinol)"
148367|NCT01755091|O3|Outcome|10 mg/Day|"Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation~Dronabinol"
148368|NCT01755091|O2|Outcome|2.5 mg/Day|"Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in~Dronabinol"
148369|NCT01755091|O1|Outcome|Sugar Pill|"Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in~Placebo (for Dronabinol)"
148370|NCT01755091|O3|Outcome|10 mg/Day|"Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation~Dronabinol"
148371|NCT01755091|O2|Outcome|2.5 mg/Day|"Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in~Dronabinol"
148372|NCT01755091|O1|Outcome|Sugar Pill|"Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in~Placebo (for Dronabinol)"
148373|NCT01755091|O3|Outcome|10 mg/Day|"Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation~Dronabinol"
148374|NCT01755091|O2|Outcome|2.5 mg/Day|"Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in~Dronabinol"
148375|NCT01755091|O1|Outcome|Sugar Pill|"Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in~Placebo (for Dronabinol)"
148376|NCT01755091|O3|Outcome|10 mg/Day|"Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation~Dronabinol"
148377|NCT01755091|O2|Outcome|2.5 mg/Day|"Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in~Dronabinol"
148378|NCT01755091|O1|Outcome|Sugar Pill|"Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in~Placebo (for Dronabinol)"
148379|NCT01755091|E3|Reported Event|10 mg/Day|"Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation~Dronabinol"
148380|NCT01755091|E2|Reported Event|2.5 mg/Day|"Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in~Dronabinol"
148381|NCT01755091|E1|Reported Event|Sugar Pill|"Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in~Placebo (for Dronabinol)"
148382|NCT01755026|B3|Baseline|Total|Total of all reporting groups
148383|NCT01755026|B2|Baseline|2 Gram Dose of Cefazolin|2 gram dose of pre-operative cefazolin
148384|NCT01755026|B1|Baseline|4 Gram Dose|4 gram dose of pre-operative prophylaxis
148385|NCT01755026|P2|Participant Flow|2 Gram Dose of Cefazolin|2 gram dose of pre-operative cefazolin
148386|NCT01755026|P1|Participant Flow|4 Gram Dose|4 gram dose of pre-operative prophylaxis
148387|NCT01755026|O2|Outcome|4 Gram Dose|4 gram dose of pre-operative prophylaxis
148388|NCT01755026|O1|Outcome|2 Gram Dose of Cefazolin|2 gram dose of pre-operative cefazolin
148389|NCT01755026|E2|Reported Event|2 Gram Dose of Cefazolin|2 gram dose of pre-operative cefazolin
148390|NCT01755026|E1|Reported Event|4 Gram Dose|4 gram dose of pre-operative prophylaxis
148399|NCT01754922|O1|Outcome|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
148400|NCT01754922|O2|Outcome|Control|Veterans deployed to regions other than Iraq and Afghanistan or non-deployed
148401|NCT01754922|O1|Outcome|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
148402|NCT01754922|E2|Reported Event|Control|OEF/OIF/OND Veterans deployed to regions other than Southwest Asia or non-deployed
148403|NCT01754922|E1|Reported Event|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
148404|NCT01754766|B4|Baseline|Total|Total of all reporting groups
148405|NCT01754766|B3|Baseline|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
148406|NCT01754766|B2|Baseline|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
148407|NCT01754766|B1|Baseline|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
148408|NCT01754766|P3|Participant Flow|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
148409|NCT01754766|P2|Participant Flow|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
148410|NCT01754766|P1|Participant Flow|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
148411|NCT01754766|O3|Outcome|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
148412|NCT01754766|O2|Outcome|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
148413|NCT01754766|O1|Outcome|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
148414|NCT01754766|O3|Outcome|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
148415|NCT01754766|O2|Outcome|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
148416|NCT01754766|O1|Outcome|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
148417|NCT01754766|O3|Outcome|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
148418|NCT01754766|O2|Outcome|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
148419|NCT01754766|O1|Outcome|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
148420|NCT01754766|E3|Reported Event|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
148421|NCT01754766|E2|Reported Event|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
148422|NCT01754766|E1|Reported Event|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
148423|NCT01754727|B1|Baseline|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
148424|NCT01754727|P1|Participant Flow|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
148425|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
148426|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
148427|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
148428|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
148429|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
148430|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
148431|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
148432|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
148433|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
148434|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
148435|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
148436|NCT01754727|E1|Reported Event|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
148437|NCT01754714|B5|Baseline|Total|Total of all reporting groups
148438|NCT01754714|B4|Baseline|No Treatment|no study drug was administered
148439|NCT01754714|B3|Baseline|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
148440|NCT01754714|B2|Baseline|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
148441|NCT01754714|B1|Baseline|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
148442|NCT01754714|P4|Participant Flow|No Treatment|No study drug was administered
148443|NCT01754714|P3|Participant Flow|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
148444|NCT01754714|P2|Participant Flow|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
148445|NCT01754714|P1|Participant Flow|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
148446|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
148447|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
164945|NCT01694108|O2|Outcome|Control Children|No intervention
148448|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
148449|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
148450|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
148451|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
148452|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
148453|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
148454|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
148455|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
148456|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
148457|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
148458|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
148459|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
148460|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
148461|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
148462|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
148463|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
148464|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
148465|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
148466|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
148467|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
148468|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
148469|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
148470|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
148471|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
148472|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
148473|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
148474|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
148475|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
148476|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
148477|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
148478|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
148479|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
148480|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
148481|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
148482|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
148483|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
148484|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
148485|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
148486|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
148487|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
148488|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
148489|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
148490|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
148491|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
148492|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
148493|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
148494|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
164946|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
148495|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
148496|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
148497|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
148498|NCT01754714|O4|Outcome|No Treatment|
148499|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
148500|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
148501|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
148502|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
148503|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
148504|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
148505|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
148506|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
148507|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
148508|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
148509|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
148510|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
148511|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
148512|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
148513|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
148514|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
148515|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
148516|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
148517|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
148518|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
148519|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
148520|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
148521|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
148522|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
148523|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
148524|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
148525|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
148526|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
148527|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
148528|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
148529|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
148530|NCT01754714|E4|Reported Event|No Treatment|No study drug was administered
148531|NCT01754714|E3|Reported Event|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
148532|NCT01754714|E2|Reported Event|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
148533|NCT01754714|E1|Reported Event|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
148534|NCT01754623|B1|Baseline|Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
148535|NCT01754623|P1|Participant Flow|Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
148577|NCT01754467|O1|Outcome|NEAT!|"Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.~NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period."
148536|NCT01754623|O2|Outcome|Resection Group -Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
148537|NCT01754623|O1|Outcome|All Participants -Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
148538|NCT01754623|O1|Outcome|Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
148539|NCT01754623|O1|Outcome|Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
148540|NCT01754623|E1|Reported Event|Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
148541|NCT01754519|B1|Baseline|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.~Therapeutic Conventional Surgery: Undergo wide local excision breast surgery~Radiation Therapy: Undergo SFRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
148542|NCT01754519|P1|Participant Flow|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.~Therapeutic Conventional Surgery: Undergo wide local excision breast surgery~Radiation Therapy: Undergo SFRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
148543|NCT01754519|O1|Outcome|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.~Therapeutic Conventional Surgery: Undergo wide local excision breast surgery~Radiation Therapy: Undergo SFRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
148544|NCT01754519|O1|Outcome|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.~Therapeutic Conventional Surgery: Undergo wide local excision breast surgery~Radiation Therapy: Undergo SFRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
148545|NCT01754519|O1|Outcome|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.~Therapeutic Conventional Surgery: Undergo wide local excision breast surgery~Radiation Therapy: Undergo SFRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
148546|NCT01754519|O1|Outcome|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.~Therapeutic Conventional Surgery: Undergo wide local excision breast surgery~Radiation Therapy: Undergo SFRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
148547|NCT01754519|O1|Outcome|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.~Therapeutic Conventional Surgery: Undergo wide local excision breast surgery~Radiation Therapy: Undergo SFRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
148548|NCT01754519|O1|Outcome|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.~Therapeutic Conventional Surgery: Undergo wide local excision breast surgery~Radiation Therapy: Undergo SFRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
148549|NCT01754519|E1|Reported Event|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.~Therapeutic Conventional Surgery: Undergo wide local excision breast surgery~Radiation Therapy: Undergo SFRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
148550|NCT01754493|B1|Baseline|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) symptoms and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
148551|NCT01754493|P1|Participant Flow|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
148552|NCT01754493|O1|Outcome|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
148553|NCT01754493|O1|Outcome|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
148554|NCT01754493|O1|Outcome|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
148555|NCT01754493|O1|Outcome|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
148556|NCT01754493|O1|Outcome|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
148557|NCT01754493|E1|Reported Event|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
148558|NCT01754480|B3|Baseline|Total|Total of all reporting groups
148559|NCT01754480|B2|Baseline|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
148560|NCT01754480|B1|Baseline|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
148561|NCT01754480|P2|Participant Flow|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
148562|NCT01754480|P1|Participant Flow|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
148563|NCT01754480|O2|Outcome|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
148564|NCT01754480|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
148565|NCT01754480|O2|Outcome|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
148566|NCT01754480|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
148567|NCT01754480|O2|Outcome|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
148568|NCT01754480|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
148569|NCT01754480|O2|Outcome|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
148570|NCT01754480|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
148571|NCT01754480|O2|Outcome|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
148572|NCT01754480|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
148573|NCT01754480|E2|Reported Event|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
148574|NCT01754480|E1|Reported Event|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
148575|NCT01754467|B1|Baseline|NEAT!|"Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.~NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period."
148576|NCT01754467|P1|Participant Flow|NEAT!|"Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.~NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period."
148741|NCT01753557|O2|Outcome|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
148578|NCT01754467|O1|Outcome|NEAT!|"Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.~NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period."
148579|NCT01754467|O1|Outcome|NEAT!|"Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.~NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period."
148580|NCT01754467|O1|Outcome|NEAT!|"Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.~NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period."
148581|NCT01754467|E1|Reported Event|NEAT!|"Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.~NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period."
148582|NCT01754402|B4|Baseline|Total|Total of all reporting groups
148583|NCT01754402|B3|Baseline|Expansion: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered at the Maximum Tolerated Dose."
148584|NCT01754402|B2|Baseline|Cohort 2: 120mg Bendamustine + 4mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort."
148585|NCT01754402|B1|Baseline|Cohort 1: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort."
148586|NCT01754402|P3|Participant Flow|Expansion: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered at the Maximum Tolerated Dose."
148587|NCT01754402|P2|Participant Flow|Cohort 2: 120mg Bendamustine + 4mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort."
148588|NCT01754402|P1|Participant Flow|Cohort 1: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort."
148589|NCT01754402|O3|Outcome|Expansion: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered at the Maximum Tolerated Dose."
148590|NCT01754402|O2|Outcome|Cohort 2: 120mg Bendamustine + 4mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort."
148591|NCT01754402|O1|Outcome|Cohort 1: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort."
148592|NCT01754402|O1|Outcome|Cohorts 1 and 2|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort. (Dose escalation)~Bendamustine: Bendamustine 120mg/m2 (cohort 1, 2) or 150 mg/m2 (cohort 3), or 180mg/m2 (cohort 4) will be administered intravenously on day 1, every 28 days for 12 cycles.~Pomalidomide: Pomalidomide 3mg (cohort 1) or 4mg (cohort 2, 3, 4) will be administered once daily orally (PO) on days 1-21, every 28 days until disease progression or death.~Dexamethasone: Dexamethasone will be administered weekly orally or intravenously on days 1, 8,"
149446|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with an attempted Attain Performa LV Lead Model 4398 implant
148593|NCT01754402|E3|Reported Event|Expansion: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days"
148594|NCT01754402|E2|Reported Event|Cohort 2: 120mg Bendamustine + 4mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days"
148595|NCT01754402|E1|Reported Event|Cohort 1: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days"
148596|NCT01754389|B4|Baseline|Total|Total of all reporting groups
148597|NCT01754389|B3|Baseline|Arm C (Experimental)|"Drug: Bortezomib, Sirolimus, Tacrolimus Other Names: Velcade~Bortezomib intravenously 1,4 and 7 days post-transplant Sirolimus, intravenously and orally, Day -3 through 3-6 months post-transplant Tacrolimus, intravenously and orally, Day -3 through 3-6 months post-transplant~Sirolimus"
148598|NCT01754389|B2|Baseline|Arm B (Experimental)|"Drug: Bortezomib, Tacrolimus, Methotrexate Other Names: Velcade~Bortezomib intravenously 1, 4 and 7 days post-transplant Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously 1,3,6 and 11 days post-transplant~Bortezomib"
148599|NCT01754389|B1|Baseline|Arm A (Standard of Care)|"Drug: Tacrolimus, Methotrexate~Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously on days 1, 3, 6 and 11 post-transplant"
148600|NCT01754389|P3|Participant Flow|Arm C (Experimental)|"Drug: Bortezomib, Sirolimus, Tacrolimus Other Names: Velcade~Bortezomib intravenously 1,4 and 7 days post-transplant Sirolimus, intravenously and orally, Day -3 through 3-6 months post-transplant Tacrolimus, intravenously and orally, Day -3 through 3-6 months post-transplant"
148601|NCT01754389|P2|Participant Flow|Arm B (Experimental)|"Drug: Bortezomib, Tacrolimus, Methotrexate Other Names: Velcade~Bortezomib intravenously 1, 4 and 7 days post-transplant Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously 1,3,6 and 11 days post-transplant"
148602|NCT01754389|P1|Participant Flow|Arm A (Standard of Care)|"Drug: Tacrolimus, Methotrexate~Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously on days 1, 3, 6 and 11 post-transplant"
148603|NCT01754389|O3|Outcome|Arm C (Experimental)|"Drug: Bortezomib, Sirolimus, Tacrolimus Other Names: Velcade~Bortezomib intravenously 1,4 and 7 days post-transplant Sirolimus, intravenously and orally, Day -3 through 3-6 months post-transplant Tacrolimus, intravenously and orally, Day -3 through 3-6 months post-transplant"
148604|NCT01754389|O2|Outcome|Arm B (Experimental)|"Drug: Bortezomib, Tacrolimus, Methotrexate Other Names: Velcade~Bortezomib intravenously 1, 4 and 7 days post-transplant Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously 1,3,6 and 11 days post-transplant"
148605|NCT01754389|O1|Outcome|Arm A (Standard of Care)|"Drug: Tacrolimus, Methotrexate~Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously on days 1, 3, 6 and 11 post-transplant"
148606|NCT01754389|O3|Outcome|Arm C (Experimental)|"Drug: Bortezomib, Sirolimus, Tacrolimus Other Names: Velcade~Bortezomib intravenously 1,4 and 7 days post-transplant Sirolimus, intravenously and orally, Day -3 through 3-6 months post-transplant Tacrolimus, intravenously and orally, Day -3 through 3-6 months post-transplant"
148607|NCT01754389|O2|Outcome|Arm B (Experimental)|"Drug: Bortezomib, Tacrolimus, Methotrexate Other Names: Velcade~Bortezomib intravenously 1, 4 and 7 days post-transplant Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously 1,3,6 and 11 days post-transplant"
148608|NCT01754389|O1|Outcome|Arm A (Standard of Care)|"Drug: Tacrolimus, Methotrexate~Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously on days 1, 3, 6 and 11 post-transplant"
148609|NCT01754389|O3|Outcome|Arm C (Experimental)|"Drug: Bortezomib, Sirolimus, Tacrolimus Other Names: Velcade~Bortezomib intravenously 1,4 and 7 days post-transplant Sirolimus, intravenously and orally, Day -3 through 3-6 months post-transplant Tacrolimus, intravenously and orally, Day -3 through 3-6 months post-transplant"
148610|NCT01754389|O2|Outcome|Arm B (Experimental)|"Drug: Bortezomib, Tacrolimus, Methotrexate Other Names: Velcade~Bortezomib intravenously 1, 4 and 7 days post-transplant Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously 1,3,6 and 11 days post-transplant"
148611|NCT01754389|O1|Outcome|Arm A (Standard of Care)|"Drug: Tacrolimus, Methotrexate~Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously on days 1, 3, 6 and 11 post-transplant"
148612|NCT01754389|O3|Outcome|Arm C (Experimental)|"Drug: Bortezomib, Sirolimus, Tacrolimus Other Names: Velcade~Bortezomib intravenously 1,4 and 7 days post-transplant Sirolimus, intravenously and orally, Day -3 through 3-6 months post-transplant Tacrolimus, intravenously and orally, Day -3 through 3-6 months post-transplant"
148613|NCT01754389|O2|Outcome|Arm B (Experimental)|"Drug: Bortezomib, Tacrolimus, Methotrexate Other Names: Velcade~Bortezomib intravenously 1, 4 and 7 days post-transplant Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously 1,3,6 and 11 days post-transplant"
148614|NCT01754389|O1|Outcome|Arm A (Standard of Care)|"Drug: Tacrolimus, Methotrexate~Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously on days 1, 3, 6 and 11 post-transplant"
148615|NCT01754389|O3|Outcome|Arm C (Experimental)|"Drug: Bortezomib, Sirolimus, Tacrolimus Other Names: Velcade~Bortezomib intravenously 1,4 and 7 days post-transplant Sirolimus, intravenously and orally, Day -3 through 3-6 months post-transplant Tacrolimus, intravenously and orally, Day -3 through 3-6 months post-transplant"
148616|NCT01754389|O2|Outcome|Arm B (Experimental)|"Drug: Bortezomib, Tacrolimus, Methotrexate Other Names: Velcade~Bortezomib intravenously 1, 4 and 7 days post-transplant Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously 1,3,6 and 11 days post-transplant"
148617|NCT01754389|O1|Outcome|Arm A (Standard of Care)|"Drug: Tacrolimus, Methotrexate~Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously on days 1, 3, 6 and 11 post-transplant"
148739|NCT01753557|P2|Participant Flow|Treatment-Relapsed|Drug: MP-424 (generic name:Telaprevir) 750mg every 8 hours(q8h) for 12 weeks Drug: RBV (Ribavirin) 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
148618|NCT01754389|E3|Reported Event|Arm C (Experimental)|"Drug: Bortezomib, Sirolimus, Tacrolimus Other Names: Velcade~Bortezomib intravenously 1,4 and 7 days post-transplant Sirolimus, intravenously and orally, Day -3 through 3-6 months post-transplant Tacrolimus, intravenously and orally, Day -3 through 3-6 months post-transplant"
148619|NCT01754389|E2|Reported Event|Arm B (Experimental)|"Drug: Bortezomib, Tacrolimus, Methotrexate Other Names: Velcade~Bortezomib intravenously 1, 4 and 7 days post-transplant Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously 1,3,6 and 11 days post-transplant"
148620|NCT01754389|E1|Reported Event|Arm A (Standard of Care)|"Drug: Tacrolimus, Methotrexate~Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously on days 1, 3, 6 and 11 post-transplant"
148621|NCT01754376|B1|Baseline|Treatment Arm|"Oral vemurafenib twice a day IV infusion of aldesleukin~Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.~Vemurafenib: Tablets given twice daily."
148622|NCT01754376|P1|Participant Flow|Treatment Arm|"Oral vemurafenib twice a day IV infusion of aldesleukin~Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.~Vemurafenib: Tablets given twice daily."
148623|NCT01754376|O1|Outcome|Treatment Arm|"Oral vemurafenib 960 milligrams twice a day plus intravenous aldesleukin 600,000 IU/kg every eight hours to tolerance (maximum 14 doses) over five days on days 15-19 of cycle 1 and on days 1-5 of cycle 2. (A cycle is 28 days)~The first course of treatment will consist of three 28-day cycles (12 weeks): 2 weeks of lead-in vemurafenib plus 3 weeks on IL-2 plus 7 weeks wait.~A second course may be given at the discretion of the investigator, if there is evidence of tumor stability or regression.~Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.~Vemurafenib: Tablets given twice daily."
148624|NCT01754376|O1|Outcome|Treatment Arm|"Oral vemurafenib 960 milligrams twice a day plus intravenous aldesleukin 600,000 IU/kg every eight hours to tolerance (maximum 14 doses) over five days on days 15-19 of cycle 1 and on days 1-5 of cycle 2. (A cycle is 28 days)~The first course of treatment will consist of three 28-day cycles (12 weeks): 2 weeks of lead-in vemurafenib plus 3 weeks on IL-2 plus 7 weeks wait.~A second course may be given at the discretion of the investigator, if there is evidence of tumor stability or regression.~Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.~Vemurafenib: Tablets given twice daily."
148625|NCT01754376|O1|Outcome|Treatment Arm|"Oral vemurafenib 960 milligrams twice a day plus intravenous aldesleukin 600,000 IU/kg every eight hours to tolerance (maximum 14 doses) over five days on days 15-19 of cycle 1 and on days 1-5 of cycle 2. (A cycle is 28 days)~The first course of treatment will consist of three 28-day cycles (12 weeks): 2 weeks of lead-in vemurafenib plus 3 weeks on IL-2 plus 7 weeks wait.~A second course may be given at the discretion of the investigator, if there is evidence of tumor stability or regression.~Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.~Vemurafenib: Tablets given twice daily."
148626|NCT01754376|O1|Outcome|Treatment Arm|"Oral vemurafenib 960 milligrams twice a day plus intravenous aldesleukin 600,000 IU/kg every eight hours to tolerance (maximum 14 doses) over five days on days 15-19 of cycle 1 and on days 1-5 of cycle 2. (A cycle is 28 days)~The first course of treatment will consist of three 28-day cycles (12 weeks): 2 weeks of lead-in vemurafenib plus 3 weeks on IL-2 plus 7 weeks wait.~A second course may be given at the discretion of the investigator, if there is evidence of tumor stability or regression.~Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.~Vemurafenib: Tablets given twice daily."
148627|NCT01754376|O1|Outcome|Treatment Arm|"Oral vemurafenib 960 milligrams twice a day plus intravenous aldesleukin 600,000 IU/kg every eight hours to tolerance (maximum 14 doses) over five days on days 15-19 of cycle 1 and on days 1-5 of cycle 2. (A cycle is 28 days)~The first course of treatment will consist of three 28-day cycles (12 weeks): 2 weeks of lead-in vemurafenib plus 3 weeks on IL-2 plus 7 weeks wait.~A second course may be given at the discretion of the investigator, if there is evidence of tumor stability or regression.~Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.~Vemurafenib: Tablets given twice daily."
148628|NCT01754376|O1|Outcome|Treatment Arm|"Oral vemurafenib twice a day IV infusion of aldesleukin~Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.~Vemurafenib: Tablets given twice daily."
148629|NCT01754376|E1|Reported Event|Treatment Arm|"Oral vemurafenib twice a day IV infusion of aldesleukin~Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.~Vemurafenib: Tablets given twice daily."
148630|NCT01754259|B3|Baseline|Total|Total of all reporting groups
148631|NCT01754259|B2|Baseline|Placebo|"Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.~Placebo Pill: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
148632|NCT01754259|B1|Baseline|Ranolazine|"subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.~Ranolazine: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
148633|NCT01754259|P2|Participant Flow|Placebo|"Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.~Placebo Pill: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
148634|NCT01754259|P1|Participant Flow|Ranolazine|"subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.~Ranolazine: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
148635|NCT01754259|O2|Outcome|Placebo|"Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.~Placebo Pill: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
148636|NCT01754259|O1|Outcome|Ranolazine|"subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.~Ranolazine: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
148637|NCT01754259|O2|Outcome|Placebo|"Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.~Placebo Pill: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
151900|NCT01739335|O1|Outcome|Mifepristone 600 mg/Day|600 mg/day mifepristone for one week
148638|NCT01754259|O1|Outcome|Ranolazine|"subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.~Ranolazine: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
148639|NCT01754259|E2|Reported Event|Placebo|"Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.~Placebo Pill: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
148640|NCT01754259|E1|Reported Event|Ranolazine|"subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.~Ranolazine: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
148641|NCT01754194|B3|Baseline|Total|Total of all reporting groups
148642|NCT01754194|B2|Baseline|Procedure Type 2|"Roux-en-Y Gastric Bypass~Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass"
148643|NCT01754194|B1|Baseline|Procedure Type 1|"Gastric Sleeve Resection~Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection"
148644|NCT01754194|P2|Participant Flow|Procedure Type 2|"Roux-en-Y Gastric Bypass~Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass"
148645|NCT01754194|P1|Participant Flow|Procedure Type 1|"Gastric Sleeve Resection~Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection"
148646|NCT01754194|O2|Outcome|Procedure Type 2|"Roux-en-Y Gastric Bypass~Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass"
148647|NCT01754194|O1|Outcome|Procedure Type 1|"Gastric Sleeve Resection~Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection"
148648|NCT01754194|O2|Outcome|Procedure Type 2|"Roux-en-Y Gastric Bypass~Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass"
148649|NCT01754194|O1|Outcome|Procedure Type 1|"Gastric Sleeve Resection~Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection"
148650|NCT01754194|O2|Outcome|Procedure Type 2|"Roux-en-Y Gastric Bypass~Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass"
148651|NCT01754194|O1|Outcome|Procedure Type 1|"Gastric Sleeve Resection~Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection"
148652|NCT01754194|O2|Outcome|Procedure Type 2|"Roux-en-Y Gastric Bypass~Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass"
148653|NCT01754194|O1|Outcome|Procedure Type 1|"Gastric Sleeve Resection~Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection"
148654|NCT01754194|O2|Outcome|Procedure Type 2|"Roux-en-Y Gastric Bypass~Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass"
148655|NCT01754194|O1|Outcome|Procedure Type 1|"Gastric Sleeve Resection~Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection"
148656|NCT01754194|O2|Outcome|Procedure Type 2|"Roux-en-Y Gastric Bypass~Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass"
148657|NCT01754194|O1|Outcome|Procedure Type 1|"Gastric Sleeve Resection~Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection"
148658|NCT01754194|O2|Outcome|Procedure Type 2|"Roux-en-Y Gastric Bypass~Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass"
148659|NCT01754194|O1|Outcome|Procedure Type 1|"Gastric Sleeve Resection~Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection"
148660|NCT01754194|O2|Outcome|Procedure Type II|Roux-en-Y Gastric Bypass
148661|NCT01754194|O1|Outcome|Procedure Type I|Gastric Sleeve Resection
148662|NCT01754194|E2|Reported Event|Procedure Type II|Roux-en-Y Gastric Bypass
148663|NCT01754194|E1|Reported Event|Procedure Type I|Gastric Sleeve Resection
148664|NCT01753856|B3|Baseline|Total|Total of all reporting groups
148665|NCT01753856|B2|Baseline|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148666|NCT01753856|B1|Baseline|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148667|NCT01753856|P2|Participant Flow|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148668|NCT01753856|P1|Participant Flow|Teriparatide|"Teriparatide: 20-microgram (µg) subcutaneous (SC) injection once daily for 6 months.~DEM: 150-milligram (mg) tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 milligrams per day (mg/day) administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 International Units per day (IU/day) administered orally for 6 months."
148732|NCT01753713|O2|Outcome|Anti-angiogenic Therapy Patients|"Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~dovitinib: Given PO~laboratory biomarker analysis: Correlative studies"
148740|NCT01753557|P1|Participant Flow|Treatment-Naive|Drug: MP-424 (generic name:Telaprevir) 750mg every 8 hours(q8h) for 12 weeks Drug: RBV (Ribavirin) 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
148669|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148670|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148671|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148672|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148673|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148674|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148675|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148676|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148677|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148678|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148679|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148733|NCT01753713|O1|Outcome|Anti-angiogenic Therapy Naive Patients|"Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~dovitinib: Given PO~laboratory biomarker analysis: Correlative studies"
149447|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with an attempted Attain Performa LV Lead Model 4298 implant
148680|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148681|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148682|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148683|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148684|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148685|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148686|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148687|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148688|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148689|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148690|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148734|NCT01753713|E2|Reported Event|Anti-angiogenic Therapy Patients|"Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~dovitinib: Given PO~laboratory biomarker analysis: Correlative studies"
149448|NCT01751022|O3|Outcome|Model 4598|Patients with an implant attempt for the Attain Performa Lead Model 4598
148691|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148692|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148693|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148694|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148695|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148696|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148697|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148698|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148699|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148700|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148701|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148735|NCT01753713|E1|Reported Event|Anti-angiogenic Therapy Naive Patients|"Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~dovitinib: Given PO~laboratory biomarker analysis: Correlative studies"
148736|NCT01753557|B3|Baseline|Total|Total of all reporting groups
148702|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148703|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148704|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148705|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148706|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148707|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148708|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148709|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148710|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148711|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148712|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148737|NCT01753557|B2|Baseline|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
148738|NCT01753557|B1|Baseline|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
151901|NCT01739335|O2|Outcome|Sugar Pill|Placebo (sugar pill) for one week
148713|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148714|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148715|NCT01753856|E2|Reported Event|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148716|NCT01753856|E1|Reported Event|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
148717|NCT01753713|B3|Baseline|Total|Total of all reporting groups
148718|NCT01753713|B2|Baseline|Anti-angiogenic Therapy Patients|"Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~dovitinib: Given PO~laboratory biomarker analysis: Correlative studies"
148719|NCT01753713|B1|Baseline|Anti-angiogenic Therapy Naive Patients|"Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~dovitinib: Given PO~laboratory biomarker analysis: Correlative studies"
148720|NCT01753713|P2|Participant Flow|Anti-angiogenic Therapy Naive Patients|"Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~dovitinib: Given PO~laboratory biomarker analysis: Correlative studies"
148721|NCT01753713|P1|Participant Flow|Anti-angiogenic Therapy Patients|"Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~dovitinib: Given PO~laboratory biomarker analysis: Correlative studies"
148722|NCT01753713|O2|Outcome|Anti-angiogenic Therapy Patients|"Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~dovitinib: Given PO~laboratory biomarker analysis: Correlative studies"
148723|NCT01753713|O1|Outcome|Anti-angiogenic Therapy Naive Patients|"Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~dovitinib: Given PO~laboratory biomarker analysis: Correlative studies"
148724|NCT01753713|O2|Outcome|Anti-angiogenic Therapy Patients|"Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~dovitinib: Given PO~laboratory biomarker analysis: Correlative studies"
148725|NCT01753713|O1|Outcome|Anti-angiogenic Therapy Naive Patients|"Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~dovitinib: Given PO~laboratory biomarker analysis: Correlative studies"
148726|NCT01753713|O2|Outcome|Anti-angiogenic Therapy Patients|"Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~dovitinib: Given PO~laboratory biomarker analysis: Correlative studies"
148727|NCT01753713|O1|Outcome|Anti-angiogenic Therapy Naive Patients|"Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~dovitinib: Given PO~laboratory biomarker analysis: Correlative studies"
148728|NCT01753713|O2|Outcome|Anti-angiogenic Therapy Patients|"Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~dovitinib: Given PO~laboratory biomarker analysis: Correlative studies"
148729|NCT01753713|O1|Outcome|Anti-angiogenic Therapy Naive Patients|"Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~dovitinib: Given PO~laboratory biomarker analysis: Correlative studies"
148730|NCT01753713|O2|Outcome|Anti-angiogenic Therapy Patients|"Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~dovitinib: Given PO~laboratory biomarker analysis: Correlative studies"
148731|NCT01753713|O1|Outcome|Anti-angiogenic Therapy Naive Patients|"Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~dovitinib: Given PO~laboratory biomarker analysis: Correlative studies"
148742|NCT01753557|O1|Outcome|Treatment-Naïve|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
148743|NCT01753557|O2|Outcome|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
148744|NCT01753557|O1|Outcome|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
148745|NCT01753557|O2|Outcome|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
148746|NCT01753557|O1|Outcome|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
148747|NCT01753557|O2|Outcome|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
148748|NCT01753557|O1|Outcome|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
148749|NCT01753557|O2|Outcome|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
148750|NCT01753557|O1|Outcome|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
148751|NCT01753557|O2|Outcome|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
148752|NCT01753557|O1|Outcome|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
148753|NCT01753557|E2|Reported Event|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
148754|NCT01753557|E1|Reported Event|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
148755|NCT01753518|B3|Baseline|Total|Total of all reporting groups
148756|NCT01753518|B2|Baseline|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
148757|NCT01753518|B1|Baseline|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
148758|NCT01753518|P2|Participant Flow|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
148759|NCT01753518|P1|Participant Flow|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
148760|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
148761|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
148762|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
148763|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
148764|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
148765|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
148766|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
148767|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
148768|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
148769|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
148770|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
148771|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
148772|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
148773|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
148774|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
148775|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
148776|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
148777|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
148778|NCT01753518|E2|Reported Event|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
148779|NCT01753518|E1|Reported Event|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
148825|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
148826|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
148827|NCT01753323|E3|Reported Event|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
157643|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
148780|NCT01753336|B1|Baseline|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
148781|NCT01753336|P1|Participant Flow|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 Units (U)/vial, 2 millilitre (mL) dilution on Day 1 of up to 3 treatment cycles. Subjects who were botulinum neurotoxin (BoNT) treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum toxin type A haemagglutinin complex (abobotulinumtoxinA).
148782|NCT01753336|O1|Outcome|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
148783|NCT01753336|O1|Outcome|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
148784|NCT01753336|O1|Outcome|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
148785|NCT01753336|O1|Outcome|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
148786|NCT01753336|O1|Outcome|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
148787|NCT01753336|O1|Outcome|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
148828|NCT01753323|E2|Reported Event|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
148829|NCT01753323|E1|Reported Event|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
148830|NCT01753310|B3|Baseline|Total Title|
148883|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
164947|NCT01694108|O2|Outcome|Control Children|No intervention
148788|NCT01753336|E1|Reported Event|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
148789|NCT01753323|B4|Baseline|Total|Total of all reporting groups
148790|NCT01753323|B3|Baseline|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
148791|NCT01753323|B2|Baseline|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
148792|NCT01753323|B1|Baseline|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
148793|NCT01753323|P3|Participant Flow|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
148794|NCT01753323|P2|Participant Flow|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
148795|NCT01753323|P1|Participant Flow|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
148796|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
148797|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
148798|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
148799|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
148800|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
148801|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
148802|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
148803|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
148804|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
148805|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
148806|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
148807|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
148808|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
148809|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
148810|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
148811|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
148812|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
148813|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
148814|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
148815|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
148816|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
148817|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
148818|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
148819|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
148820|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
148821|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
148822|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
148823|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
148824|NCT01753323|O3|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
148831|NCT01753310|B2|Baseline|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
148832|NCT01753310|B1|Baseline|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
148833|NCT01753310|P2|Participant Flow|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
148834|NCT01753310|P1|Participant Flow|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
148835|NCT01753310|O2|Outcome|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
148836|NCT01753310|O1|Outcome|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
148837|NCT01753310|O2|Outcome|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
148838|NCT01753310|O1|Outcome|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
148839|NCT01753310|O2|Outcome|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
148840|NCT01753310|O1|Outcome|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
148841|NCT01753310|O2|Outcome|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
148842|NCT01753310|O1|Outcome|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
148843|NCT01753310|O2|Outcome|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
148844|NCT01753310|O1|Outcome|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
148845|NCT01753310|O2|Outcome|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
148846|NCT01753310|O1|Outcome|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
148847|NCT01753310|O2|Outcome|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
148848|NCT01753310|O1|Outcome|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
157644|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
148849|NCT01753310|O2|Outcome|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
148850|NCT01753310|O1|Outcome|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
148851|NCT01753310|E2|Reported Event|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
148852|NCT01753310|E1|Reported Event|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
148853|NCT01753115|B4|Baseline|Total|Total of all reporting groups
148854|NCT01753115|B3|Baseline|BioThrax Only|BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
148855|NCT01753115|B2|Baseline|BioThrax + Ciprofloxacin no PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
148856|NCT01753115|B1|Baseline|BioThrax + Ciprofloxacin PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
148857|NCT01753115|P3|Participant Flow|BioThrax Only|BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
148858|NCT01753115|P2|Participant Flow|BioThrax + Ciprofloxacin no PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
148859|NCT01753115|P1|Participant Flow|BioThrax + Ciprofloxacin PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
148860|NCT01753115|O2|Outcome|BioThrax Only (Arm 3)|BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
148861|NCT01753115|O1|Outcome|BioThrax + Ciprofloxacin (Arms 1 + 2)|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
148862|NCT01753115|O1|Outcome|Arm 1 = BioThrax (0.5 mL) + Ciprofloxacin (500 mg Bid) + PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
148863|NCT01753115|E3|Reported Event|BioThrax Only|BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
148864|NCT01753115|E2|Reported Event|BioThrax + Ciprofloxacin no PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
148865|NCT01753115|E1|Reported Event|BioThrax + Ciprofloxacin PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
148866|NCT01753076|B3|Baseline|Total|Total of all reporting groups
148867|NCT01753076|B2|Baseline|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46.
148868|NCT01753076|B1|Baseline|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46.
148869|NCT01753076|P2|Participant Flow|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46.
148870|NCT01753076|P1|Participant Flow|Placebo|Participants (par) received placebo once every 2 weeks by intravenous infusion up to Week 46.
148871|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
148872|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
148873|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
148874|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
148875|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
148876|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
148877|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 mg/kg once every 2 weeks by intravenous infusion up to Week 46. Outcome assessments conducted at Week 48 and Week 60.
148878|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Outcome assessments conducted at Week 48 and Week 60.
148879|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
148880|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
148881|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
148882|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
164948|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
148884|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
148885|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
148886|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
148887|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
148888|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
148889|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
148890|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
148891|NCT01753076|E2|Reported Event|Ozanezumab IV|Participants received ozanezumab 15 mg/kg once every 2 weeks by intravenous infusion up to Week 46.
148892|NCT01753076|E1|Reported Event|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46.
148893|NCT01752907|B3|Baseline|Total|Total of all reporting groups
148894|NCT01752907|B2|Baseline|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
148895|NCT01752907|B1|Baseline|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
148896|NCT01752907|P2|Participant Flow|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
148897|NCT01752907|P1|Participant Flow|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
148898|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
148899|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
148900|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
148901|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
148902|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
148903|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
148904|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
148905|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
148906|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
148907|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
148908|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
148909|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
148910|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
148911|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
148912|NCT01752907|E2|Reported Event|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
148913|NCT01752907|E1|Reported Event|General Chemotherapy Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
148914|NCT01752855|B3|Baseline|Total|Total of all reporting groups
148915|NCT01752855|B2|Baseline|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
148916|NCT01752855|B1|Baseline|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
148917|NCT01752855|P2|Participant Flow|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
148918|NCT01752855|P1|Participant Flow|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
148919|NCT01752855|O2|Outcome|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
148920|NCT01752855|O1|Outcome|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
148921|NCT01752855|O2|Outcome|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
148922|NCT01752855|O1|Outcome|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
148923|NCT01752855|O2|Outcome|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
148924|NCT01752855|O1|Outcome|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
148925|NCT01752855|O2|Outcome|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
148926|NCT01752855|O1|Outcome|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
148927|NCT01752855|O2|Outcome|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
148928|NCT01752855|O1|Outcome|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
148929|NCT01752855|E2|Reported Event|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
148930|NCT01752855|E1|Reported Event|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week.
148931|NCT01752712|B3|Baseline|Total|Total of all reporting groups
148932|NCT01752712|B2|Baseline|CBSST + Placebo|"Cognitive Behavioral Social Skills Training with placebo nasal spray. The placebo nasal spray bottles will be matched in appearance to the oxytocin nasal spray bottles and similarly administered intranasally in two doses (morning and evening).~CBSST + Placebo: Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group."
148975|NCT01752023|O1|Outcome|Cisplatin + Gemcitabine With SUBATM-itraconazole|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.~Arm A: Experimental Arm"
148976|NCT01752023|O2|Outcome|Arm B|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.~Arm B: Active Comparator"
148933|NCT01752712|B1|Baseline|CBSST + Oxytocin|"Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment. Participants will receive 80 IU/day of oxytocin administered intranasally in two doses (40 IU morning and evening).~CBSST + Oxytocin: The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group."
148934|NCT01752712|P2|Participant Flow|CBSST + Placebo|"Cognitive Behavioral Social Skills Training with placebo nasal spray. The placebo nasal spray bottles will be matched in appearance to the oxytocin nasal spray bottles and similarly administered intranasally in two doses (morning and evening).~CBSST + Placebo: Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group."
148935|NCT01752712|P1|Participant Flow|CBSST + Oxytocin|"Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment. Participants will receive 80 IU/day of oxytocin administered intranasally in two doses (40 IU morning and evening).~CBSST + Oxytocin: The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group."
148936|NCT01752712|O2|Outcome|CBSST + Placebo|"Cognitive Behavioral Social Skills Training with placebo nasal spray. The placebo nasal spray bottles will be matched in appearance to the oxytocin nasal spray bottles and similarly administered intranasally in two doses (morning and evening).~CBSST + Placebo: Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group."
148937|NCT01752712|O1|Outcome|CBSST + Oxytocin|"Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment. Participants will receive 80 IU/day of oxytocin administered intranasally in two doses (40 IU morning and evening).~CBSST + Oxytocin: The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group."
148938|NCT01752712|O2|Outcome|CBSST + Placebo|"Cognitive Behavioral Social Skills Training with placebo nasal spray. The placebo nasal spray bottles will be matched in appearance to the oxytocin nasal spray bottles and similarly administered intranasally in two doses (morning and evening).~CBSST + Placebo: Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group."
148939|NCT01752712|O1|Outcome|CBSST + Oxytocin|"Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment. Participants will receive 80 IU/day of oxytocin administered intranasally in two doses (40 IU morning and evening).~CBSST + Oxytocin: The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group."
148940|NCT01752712|O2|Outcome|CBSST + Placebo|"Cognitive Behavioral Social Skills Training with placebo nasal spray. The placebo nasal spray bottles will be matched in appearance to the oxytocin nasal spray bottles and similarly administered intranasally in two doses (morning and evening).~CBSST + Placebo: Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group."
148941|NCT01752712|O1|Outcome|CBSST + Oxytocin|"Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment. Participants will receive 80 IU/day of oxytocin administered intranasally in two doses (40 IU morning and evening).~CBSST + Oxytocin: The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group."
148942|NCT01752712|O2|Outcome|CBSST + Placebo|"Cognitive Behavioral Social Skills Training with placebo nasal spray. The placebo nasal spray bottles will be matched in appearance to the oxytocin nasal spray bottles and similarly administered intranasally in two doses (morning and evening).~CBSST + Placebo: Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group."
148943|NCT01752712|O1|Outcome|CBSST + Oxytocin|"Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment. Participants will receive 80 IU/day of oxytocin administered intranasally in two doses (40 IU morning and evening).~CBSST + Oxytocin: The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group."
148944|NCT01752712|O2|Outcome|CBSST + Placebo|"Cognitive Behavioral Social Skills Training with placebo nasal spray. The placebo nasal spray bottles will be matched in appearance to the oxytocin nasal spray bottles and similarly administered intranasally in two doses (morning and evening).~CBSST + Placebo: Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group."
148945|NCT01752712|O1|Outcome|CBSST + Oxytocin|"Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment. Participants will receive 80 IU/day of oxytocin administered intranasally in two doses (40 IU morning and evening).~CBSST + Oxytocin: The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group."
164949|NCT01694108|O2|Outcome|Control Children|No intervention
148946|NCT01752712|O2|Outcome|CBSST + Placebo|"Cognitive Behavioral Social Skills Training with placebo nasal spray. The placebo nasal spray bottles will be matched in appearance to the oxytocin nasal spray bottles and similarly administered intranasally in two doses (morning and evening).~CBSST + Placebo: Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group."
148947|NCT01752712|O1|Outcome|CBSST + Oxytocin|"Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment. Participants will receive 80 IU/day of oxytocin administered intranasally in two doses (40 IU morning and evening).~CBSST + Oxytocin: The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group."
148948|NCT01752712|E2|Reported Event|CBSST + Placebo|"Cognitive Behavioral Social Skills Training with placebo nasal spray. The placebo nasal spray bottles will be matched in appearance to the oxytocin nasal spray bottles and similarly administered intranasally in two doses (morning and evening).~CBSST + Placebo: Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group."
148949|NCT01752712|E1|Reported Event|CBSST + Oxytocin|"Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment. Participants will receive 80 IU/day of oxytocin administered intranasally in two doses (40 IU morning and evening).~CBSST + Oxytocin: The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group."
148950|NCT01752400|B1|Baseline|AUY922|"Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes~AUY922"
148951|NCT01752400|P1|Participant Flow|AUY922|"Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes~AUY922"
148952|NCT01752400|O1|Outcome|AUY922|Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes
148953|NCT01752400|O1|Outcome|AUY922|Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes
148954|NCT01752400|O1|Outcome|AUY922|Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes
148955|NCT01752400|O1|Outcome|AUY922|Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes
148956|NCT01752400|O1|Outcome|AUY922|Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes
148957|NCT01752400|O1|Outcome|AUY922|Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes
148958|NCT01752400|O1|Outcome|AUY922|Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes
148959|NCT01752400|O1|Outcome|AUY922|Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes
148960|NCT01752400|E1|Reported Event|AUY922|Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes
148961|NCT01752023|B3|Baseline|Total|Total of all reporting groups
148962|NCT01752023|B2|Baseline|Arm B|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.~Arm B: Active Comparator"
148963|NCT01752023|B1|Baseline|Arm A|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.~Arm A: Experimental Arm"
148964|NCT01752023|P2|Participant Flow|Cisplatin + Gemcitabine|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.~Arm B: Active Comparator"
148965|NCT01752023|P1|Participant Flow|Cisplatin + Gemcitabine With SUBATM-itraconazole|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.~Arm A: Experimental Arm"
148966|NCT01752023|O2|Outcome|Cisplatin + Gemcitabine|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.~Arm B: Active Comparator"
148967|NCT01752023|O1|Outcome|Cisplatin + Gemcitabine With SUBATM-itraconazole|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.~Arm A: Experimental Arm"
148968|NCT01752023|O2|Outcome|Cisplatin + Gemcitabine|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.~Arm B: Active Comparator"
148969|NCT01752023|O1|Outcome|Cisplatin + Gemcitabine With SUBATM-itraconazole|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.~Arm A: Experimental Arm"
148970|NCT01752023|O2|Outcome|Cisplatin + Gemcitabine|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.~Arm B: Active Comparator"
148971|NCT01752023|O1|Outcome|Cisplatin + Gemcitabine With SUBATM-itraconazole|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.~Arm A: Experimental Arm"
148972|NCT01752023|O2|Outcome|Cisplatin + Gemcitabine|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.~Cisplatin + Gemcitabine: Active Comparator"
148973|NCT01752023|O1|Outcome|Cisplatin + Gemcitabine With SUBATM-itraconazole|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.~Cisplatin + Gemcitabine with SUBATM-itraconazole: Experimental Arm"
148974|NCT01752023|O2|Outcome|Cisplatin + Gemcitabine|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.~Arm B: Active Comparator"
149449|NCT01751022|O2|Outcome|Model 4398|Patients with an implant attempt for the Attain Performa Lead Model 4398
148977|NCT01752023|O1|Outcome|Arm A|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.~Arm A: Experimental Arm"
148978|NCT01752023|E2|Reported Event|Arm B|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.~Arm B: Active Comparator"
148979|NCT01752023|E1|Reported Event|Arm A|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.~Arm A: Experimental Arm"
148980|NCT01751971|B3|Baseline|Total|Total of all reporting groups
148981|NCT01751971|B2|Baseline|Air First|"Participants participate in the air night (sham) first, then the oxygen night second.~Sham: Medical air with 21% oxygen e.g. via Pink venturi mask"
148982|NCT01751971|B1|Baseline|Oxygen First|"Participants participate in inspired oxygen arm (40% oxygen) first, then the air night (21% oxygen) second~Inspired oxygen (40%): Supplemental oxygen at approximately 40% e.g. via Pink venturi mask"
148983|NCT01751971|P2|Participant Flow|Air First|"Participants participate in the air night (sham) first, then the oxygen night second.~Sham: Medical air with 21% oxygen e.g. via Pink venturi mask"
148984|NCT01751971|P1|Participant Flow|Oxygen First|"Participants participate in inspired oxygen arm (40% oxygen) first, then the air night (21% oxygen) second~Inspired oxygen (40%): Supplemental oxygen at approximately 40% e.g. via Pink venturi mask"
148985|NCT01751971|O2|Outcome|Sham|Sham: Medical air with 21% oxygen e.g. via Pink venturi mask
148986|NCT01751971|O1|Outcome|Inspired Oxygen|Inspired oxygen (40%) via Pink venturi mask
148987|NCT01751971|O1|Outcome|All Participants|Data are presented as a single arm because results are inherently a comparison between arms. Participants were asked to rate whether their sleep quality was better/same/worse on study night 2 versus study night 1. Data are presented in terms of better/same/worse on oxygen compared to sham.
148988|NCT01751971|O2|Outcome|Sham|"Sham: Medical air with 21% oxygen e.g. via Pink venturi mask Arm here is defined as the Sham Intervention. 18 participants participated in inspired oxygen arm (40% oxygen) first, then the air night (21% oxygen) second. 18 participants participated in the other order."
148989|NCT01751971|O1|Outcome|Inspired Oxygen|"Inspired oxygen (40%) for 1 night via venturi mask. Arm here is defined as the Oxygen Intervention. 18 participants participated in inspired oxygen arm (40% oxygen) first, then the air night (21% oxygen) second. 18 participants participated in the other order."
148990|NCT01751971|O2|Outcome|Sham|Sham: Medical air with 21% oxygen e.g. via Pink venturi mask
148991|NCT01751971|O1|Outcome|Inspired Oxygen|Inspired oxygen (40%): Supplemental oxygen at approximately 40% e.g. via Pink venturi mask
148992|NCT01751971|O2|Outcome|Sham|Sham: Medical air with 21% oxygen e.g. via Pink venturi mask
148993|NCT01751971|O1|Outcome|Inspired Oxygen|Inspired oxygen (40%): Supplemental oxygen at approximately 40% e.g. via Pink venturi mask
148994|NCT01751971|O2|Outcome|Sham|Sham: Medical air with 21% oxygen via venturi mask
148995|NCT01751971|O1|Outcome|Inspired Oxygen|Inspired oxygen (40%) for 1 night via venturi mask.
148996|NCT01751971|E2|Reported Event|Sham|Sham, room air
148997|NCT01751971|E1|Reported Event|Inspired Oxygen|Inspired Oxygen 40%
148998|NCT01751906|B3|Baseline|Total|Total of all reporting groups
148999|NCT01751906|B2|Baseline|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149000|NCT01751906|B1|Baseline|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149001|NCT01751906|P2|Participant Flow|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149002|NCT01751906|P1|Participant Flow|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149243|NCT01751308|P1|Participant Flow|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression (DP) or discontinuation due to adverse events (AE) or death (from any cause).
149450|NCT01751022|O1|Outcome|Model 4298|Patients with an implant attempt for the Attain Performa Lead Model 4298
149003|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149004|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149005|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149006|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149007|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149008|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149009|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149010|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149011|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149244|NCT01751308|O1|Outcome|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149012|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149013|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149014|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149015|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149016|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149017|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149018|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149019|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149020|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149265|NCT01751308|O1|Outcome|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149021|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149022|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149023|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149024|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149025|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149026|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149027|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149028|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149029|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149245|NCT01751308|O1|Outcome|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149030|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149031|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149032|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149033|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149034|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149035|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149036|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149037|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149038|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149246|NCT01751308|O4|Outcome|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149039|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149040|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149041|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149042|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149043|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149044|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149045|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149046|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149047|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149247|NCT01751308|O3|Outcome|Phase 1 and 2: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle (at the MTD dose determined in Phase 1) in Phase 1 and Phase 2 until DP or discontinuation due to AE or death (from any cause).
149048|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149049|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149050|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149051|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149052|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149053|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149054|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149055|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149056|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149248|NCT01751308|O2|Outcome|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149057|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149058|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149059|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149060|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149061|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149062|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149063|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149064|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149065|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149249|NCT01751308|O1|Outcome|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149066|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149067|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149068|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149069|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149070|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149071|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149072|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149073|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149074|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149250|NCT01751308|O4|Outcome|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149075|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149076|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149077|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149078|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149079|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149080|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149081|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149082|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149083|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149251|NCT01751308|O3|Outcome|Phase 1 and 2: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle (at the MTD dose determined in Phase 1) in Phase 1 and Phase 2 until DP or discontinuation due to AE or death (from any cause).
149084|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149085|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149086|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149087|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149088|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149089|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149090|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149091|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149092|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149252|NCT01751308|O2|Outcome|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AEor death (from any cause).
149093|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149094|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149095|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149096|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149097|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149098|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149099|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149100|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149101|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149253|NCT01751308|O1|Outcome|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149102|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149103|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149104|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149105|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149106|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149107|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149108|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149109|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149110|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149254|NCT01751308|O4|Outcome|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149111|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149112|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149113|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149114|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149115|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149116|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149117|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149118|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149119|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149255|NCT01751308|O3|Outcome|Phase 1 and 2: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle (at the MTD dose determined in Phase 1) in Phase 1 and Phase 2 until DP or discontinuation due to AE or death (from any cause).
149120|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149121|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149122|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149123|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149124|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149125|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149126|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149127|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149128|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149256|NCT01751308|O2|Outcome|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149129|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149130|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149131|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149132|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149133|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149134|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149135|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149136|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149137|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149257|NCT01751308|O1|Outcome|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149138|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149139|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149140|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149141|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149142|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149143|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149144|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149145|NCT01751906|O2|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149146|NCT01751906|O1|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149258|NCT01751308|O4|Outcome|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149147|NCT01751906|E2|Reported Event|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149148|NCT01751906|E1|Reported Event|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
149149|NCT01751867|B3|Baseline|Total|Total of all reporting groups
149150|NCT01751867|B2|Baseline|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
149151|NCT01751867|B1|Baseline|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
149152|NCT01751867|P2|Participant Flow|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
149153|NCT01751867|P1|Participant Flow|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
149154|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
149155|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
149156|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
149157|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
149158|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
149159|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
149160|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
149161|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
149162|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
149163|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
149164|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
149165|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
149166|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
149167|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
149168|NCT01751867|E2|Reported Event|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
149169|NCT01751867|E1|Reported Event|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
149170|NCT01751802|B3|Baseline|Total|Total of all reporting groups
149171|NCT01751802|B2|Baseline|Placebo Then Ecopipam Then Placebo|Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
149172|NCT01751802|B1|Baseline|Ecopipam Then Placebo Then Ecopipam|Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
149259|NCT01751308|O3|Outcome|Phase 1 and 2: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle (at the MTD dose determined in Phase 1) in Phase 1 and Phase 2 until DP or discontinuation due to AE or death (from any cause).
164950|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
149173|NCT01751802|P2|Participant Flow|Placebo Then Ecopipam Then Placebo|Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
149174|NCT01751802|P1|Participant Flow|Ecopipam Then Placebo Then Ecopipam|Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
149175|NCT01751802|O2|Outcome|Placebo|"Inactive substance being tested, orally once a day at bedtime for 6 weeks~Placebo: Placebo for Ecopipam"
149176|NCT01751802|O1|Outcome|Ecopipam|"Active substance being tested, orally once a day at bedtime for 6 weeks~Ecopipam: Antagonist of the dopamine D1 receptor"
149177|NCT01751802|O2|Outcome|Placebo|"Inactive substance being tested, orally once a day at bedtime~Placebo: Placebo for Ecopipam"
149178|NCT01751802|O1|Outcome|Ecopipam|"Active substance being tested, orally once a day at bedtime~Ecopipam: Antagonist of the dopamine D1 receptor"
149179|NCT01751802|O4|Outcome|Subject #4: Placebo Then Ecopipam Then Placebo|Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
149180|NCT01751802|O3|Outcome|Subject #3: Placebo Then Ecopipam Then Placebo|Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
149181|NCT01751802|O2|Outcome|Subject #2: Ecopipam Then Placebo Then Ecopipam|Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
149182|NCT01751802|O1|Outcome|Subject #1: Ecopipam Then Placebo Then Ecopipam|Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
149183|NCT01751802|E2|Reported Event|Placebo|"Inactive substance being tested, orally once a day at bedtime~Placebo: Placebo for Ecopipam"
149184|NCT01751802|E1|Reported Event|Ecopipam|"Active substance being tested, orally once a day at bedtime~Ecopipam: Antagonist of the dopamine D1 receptor"
149185|NCT01751724|B3|Baseline|Total|Total of all reporting groups
149186|NCT01751724|B2|Baseline|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).~Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149187|NCT01751724|B1|Baseline|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.~Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149188|NCT01751724|P2|Participant Flow|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).~Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149189|NCT01751724|P1|Participant Flow|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.~Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149190|NCT01751724|O2|Outcome|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).~Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149560|NCT01750281|B1|Baseline|Placebo + Docetaxel 75 mg/m^2|Oral placebo BD and intravenous docetaxel on day 1 of every 21 day cycle
149191|NCT01751724|O1|Outcome|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.~Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149192|NCT01751724|O2|Outcome|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).~Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149193|NCT01751724|O1|Outcome|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.~Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149194|NCT01751724|O2|Outcome|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).~Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149195|NCT01751724|O1|Outcome|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.~Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149196|NCT01751724|O2|Outcome|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).~Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149197|NCT01751724|O1|Outcome|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.~Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149198|NCT01751724|O2|Outcome|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).~Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149199|NCT01751724|O1|Outcome|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.~Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149200|NCT01751724|O2|Outcome|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).~Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149260|NCT01751308|O2|Outcome|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149261|NCT01751308|O1|Outcome|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149201|NCT01751724|O1|Outcome|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.~Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149202|NCT01751724|O2|Outcome|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).~Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149203|NCT01751724|O1|Outcome|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.~Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149204|NCT01751724|O2|Outcome|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).~Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149205|NCT01751724|O1|Outcome|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.~Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149206|NCT01751724|O2|Outcome|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).~Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149207|NCT01751724|O1|Outcome|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.~Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149208|NCT01751724|O2|Outcome|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).~Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149209|NCT01751724|O1|Outcome|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.~Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149210|NCT01751724|O2|Outcome|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).~Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149262|NCT01751308|O4|Outcome|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149263|NCT01751308|O3|Outcome|Phase 1: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149211|NCT01751724|O1|Outcome|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.~Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149212|NCT01751724|E2|Reported Event|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).~Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149213|NCT01751724|E1|Reported Event|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.~Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
149214|NCT01751412|B1|Baseline|Proton Radiation|Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
149215|NCT01751412|P1|Participant Flow|Proton Radiation|Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
149216|NCT01751412|O1|Outcome|Proton Radiation|Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
149217|NCT01751412|O1|Outcome|Proton Radiation|Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
149218|NCT01751412|O1|Outcome|Proton Radiation|Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
149219|NCT01751412|O1|Outcome|Proton Radiation|Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
149220|NCT01751412|O1|Outcome|Proton Radiation|Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
149221|NCT01751412|O1|Outcome|Proton Radiation|Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
149222|NCT01751412|O1|Outcome|Proton Radiation|Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
149223|NCT01751412|E1|Reported Event|Proton Radiation|Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
149224|NCT01751386|B3|Baseline|Total|Total of all reporting groups
149225|NCT01751386|B2|Baseline|Placebo|Placebo capsules, similar to baclofen in appearance, texture, taste, and odor
149226|NCT01751386|B1|Baseline|Baclofen|Baclofen capsules: 15 mg/day (5 mg t.i.d.; titration phase) for 3 days, followed by 30 mg/day (10 mg t.i.d.; target dose) until the alcohol laboratory session; then, 15 mg/day (5 mg t.i.d.; taper down) for three additional days.
149227|NCT01751386|P2|Participant Flow|Placebo|Placebo capsules, similar to baclofen in appearance, texture, taste, and odor
149228|NCT01751386|P1|Participant Flow|Baclofen|Baclofen capsules: 15 mg/day (5 mg t.i.d.; titration phase) for 3 days, followed by 30 mg/day (10 mg t.i.d.; target dose) until the alcohol laboratory session; then, 15 mg/day (5 mg t.i.d.; taper down) for three additional days.
149229|NCT01751386|O2|Outcome|Placebo|Placebo capsules, similar to baclofen in appearance, texture, taste, and odor
149230|NCT01751386|O1|Outcome|Baclofen|Baclofen capsules: 15 mg/day (5 mg t.i.d.; titration phase) for 3 days, followed by 30 mg/day (10 mg t.i.d.; target dose) until the alcohol laboratory session; then, 15 mg/day (5 mg t.i.d.; taper down) for three additional days.
149231|NCT01751386|E2|Reported Event|Placebo|Placebo capsules, similar to baclofen in appearance, texture, taste, and odor
149232|NCT01751386|E1|Reported Event|Baclofen|Baclofen capsules: 15 mg/day (5 mg t.i.d.; titration phase) for 3 days, followed by 30 mg/day (10 mg t.i.d.; target dose) until the alcohol laboratory session; then, 15 mg/day (5 mg t.i.d.; taper down) for three additional days.
149233|NCT01751308|B6|Baseline|Total|Total of all reporting groups
149234|NCT01751308|B5|Baseline|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the maximum tolerated dose (MTD) as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149235|NCT01751308|B4|Baseline|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149236|NCT01751308|B3|Baseline|Phase 1: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149237|NCT01751308|B2|Baseline|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149238|NCT01751308|B1|Baseline|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149239|NCT01751308|P5|Participant Flow|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149240|NCT01751308|P4|Participant Flow|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149241|NCT01751308|P3|Participant Flow|Phase 1: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149242|NCT01751308|P2|Participant Flow|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149264|NCT01751308|O2|Outcome|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149266|NCT01751308|O5|Outcome|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the maximum tolerated dose (MTD) as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149267|NCT01751308|O4|Outcome|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149268|NCT01751308|O3|Outcome|Phase 1: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149269|NCT01751308|O2|Outcome|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149270|NCT01751308|O1|Outcome|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149271|NCT01751308|O1|Outcome|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149272|NCT01751308|O1|Outcome|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149273|NCT01751308|O1|Outcome|Phase 1: Overall Population|Cabazitaxel 20 mg/m^2, 25 mg/m^2, 30 mg/m^2 or 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149274|NCT01751308|E5|Reported Event|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149275|NCT01751308|E4|Reported Event|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149276|NCT01751308|E3|Reported Event|Phase 1: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149277|NCT01751308|E2|Reported Event|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149278|NCT01751308|E1|Reported Event|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
149279|NCT01751178|B4|Baseline|Total|Total of all reporting groups
149280|NCT01751178|B3|Baseline|Reference|Brushing alone with the standard toothpaste for 1 timed minute twice daily for 6 weeks.
149281|NCT01751178|B2|Baseline|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
149282|NCT01751178|B1|Baseline|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
149283|NCT01751178|P3|Participant Flow|Reference|Brushing alone with the standard toothpaste for one timed minute twice daily for 6 weeks.
149284|NCT01751178|P2|Participant Flow|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
149285|NCT01751178|P1|Participant Flow|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
149286|NCT01751178|O3|Outcome|Reference|Brushing alone with the standard toothpaste for one timed minute twice daily for 6 weeks.
149287|NCT01751178|O2|Outcome|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
149288|NCT01751178|O1|Outcome|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
149289|NCT01751178|O3|Outcome|Reference|Brusing alone with the standard toothpaste for one timed minute twice daily for 6 weeks.
149290|NCT01751178|O2|Outcome|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
149291|NCT01751178|O1|Outcome|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
149292|NCT01751178|O3|Outcome|Reference|Brushing alone with the standard toothpaste for 1 timed minute twice daily for 6 weeks
149293|NCT01751178|O2|Outcome|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
149294|NCT01751178|O1|Outcome|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
149295|NCT01751178|O3|Outcome|Reference|Brushing alone with the standard toothpaste for 1 timed minute twice daily for 6 weeks.
149296|NCT01751178|O2|Outcome|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
149297|NCT01751178|O1|Outcome|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
149298|NCT01751178|E3|Reported Event|Reference|Brushing alone with the standard toothpaste for one timed minute twice daily for 6 weeks.
149299|NCT01751178|E2|Reported Event|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
149300|NCT01751178|E1|Reported Event|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
149301|NCT01751165|B4|Baseline|Total|Total of all reporting groups
149302|NCT01751165|B3|Baseline|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
149303|NCT01751165|B2|Baseline|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
149304|NCT01751165|B1|Baseline|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
149305|NCT01751165|P3|Participant Flow|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
149306|NCT01751165|P2|Participant Flow|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
149307|NCT01751165|P1|Participant Flow|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
149308|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
149309|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
149310|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
149311|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
149312|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
149313|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
149314|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
149315|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
149316|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
149317|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
149318|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
149319|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
149320|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
149321|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
149322|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
149323|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
149324|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
149325|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
149326|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
149327|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
149328|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
149329|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
149330|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
149331|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
149332|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
149333|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
149334|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
149335|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
149336|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
149337|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
149338|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
149339|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
149340|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
149341|NCT01751165|O2|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
149342|NCT01751165|O1|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
149343|NCT01751165|E3|Reported Event|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
149344|NCT01751165|E2|Reported Event|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
149345|NCT01751165|E1|Reported Event|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
149346|NCT01751113|B1|Baseline|Ado 50/250 µg+Tio 18 µg, Ado 50/250 µg, Tio 18 µg|All participants received one of the following 3 treatments in one of three 4-week treatment periods separated by a 2-week washout period:Ado 50/250 µg BID (morning and evening) + Tio 18 µg QD (morning), Ado 50/250 µg BID (morning and evening) + Tio matching placebo QD (morning), and Tio 18 µg QD (morning) + Ado matching placebo BID (morning and evening). Participants were randomized to one of the 6 following treatment sequences: (1) Ado 50/250 µg+Tio 18 µg, Tio 18 µg, Ado 50/250 µg (2) Tio 18 µg, Ado 50/250 µg, Ado 50/250 µg+Tio 18 µg (3) Ado 50/250 µg, Ado 50/250 µg+Tio 18 µg, Tio 18 µg (4) Ado 50/250 µg, Tio 18 µg, Ado 50/250 µg+Tio 18 µg (5) Ado 50/250 µg+Tio 18 µg, Ado 50/250 µg, Tio 18 µg (6) Tio 18 µg, Ado 50/250 µg+Tio 18 µg, Ado 50/250 µg. Ado 50/250 µg and its matching placebo were administered via DISKUS inhaler and Tio 18 µg and its matching placebo were administered via HandiHaler inhaler. Participants used salbutamol inhaler as relief medication throughout the study.
149347|NCT01751113|P6|Participant Flow|Sequence 6: Tio 18 µg, Ado 50/250 µg+Tio 18 µg, Ado 50/250 µg|Participants received Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening), Ado 50/250 µg BID plus Tio 18 µg QD (morning), and Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning) in Treatment Period 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via a HandiHaler inhaler. Participants were provided with salbutamol inhaler to be used as relief medication throughout the study.
149348|NCT01751113|P5|Participant Flow|Sequence 5: Ado 50/250 µg+Tio 18 µg, Ado 50/250 µg, Tio 18 µg|Participants received Ado 50/250 µg BID plus Tio 18 µg QD (morning), Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning) and Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening) in Treatment Period 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via a HandiHaler inhaler. Participants were provided with salbutamol inhaler to be used as relief medication throughout the study.
149349|NCT01751113|P4|Participant Flow|Sequence 4: Ado 50/250 µg, Tio 18 µg, Ado 50/250 µg+Tio 18 µg|Participants received Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning), Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening), and Ado 50/250 µg BID plus Tio 18 µg QD (morning) in Treatment Period 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via a HandiHaler inhaler. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149350|NCT01751113|P3|Participant Flow|Sequence 3: Ado 50/250 µg, Ado 50/250 µg+Tio 18 µg, Tio 18 µg|Participants received Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning), Ado 50/250 µg BID plus Tio 18 µg QD (morning), and Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening) in Treatment Period 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via HandiHaler inhaler. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149351|NCT01751113|P2|Participant Flow|Sequence 2: Tio 18 µg, Ado 50/250 µg, Ado 50/250 µg+Tio 18 µg|Participants received Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening), Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning), and Ado 50/250 µg BID plus Tio 18 µg QD (morning) in Treatment Periods 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via a HandiHaler inhaler. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149352|NCT01751113|P1|Participant Flow|Sequence 1: Ado 50/250 µg+Tio 18 µg, Tio 18 µg, Ado 50/250 µg|Participants received salmeterol xinafoate/fluticasone propionate (Ado) 50/250 micrograms (µg) twice daily (BID) (morning and evening) plus tiotropium bromide (Tio) 18 µg once daily (QD) (morning), Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening), and Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning) in Treatment Periods 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via a HandiHaler inhaler. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149353|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149354|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149355|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149356|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149357|NCT01751113|O2|Outcome|Tio 18 µg BID|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149358|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149359|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149360|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149361|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149362|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149363|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149364|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149365|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149366|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149367|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149368|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149369|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149370|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149371|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149443|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted and valid pacing thresholds measured at the 6 month follow-up.
149372|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149373|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149374|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149375|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149376|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149377|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149378|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149379|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149380|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149381|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149382|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149383|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149384|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149385|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149386|NCT01751113|E3|Reported Event|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149387|NCT01751113|E2|Reported Event|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149388|NCT01751113|E1|Reported Event|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
149389|NCT01751087|B4|Baseline|Total|Total of all reporting groups
157645|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
149390|NCT01751087|B3|Baseline|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
149391|NCT01751087|B2|Baseline|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
149392|NCT01751087|B1|Baseline|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
149393|NCT01751087|P3|Participant Flow|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
149394|NCT01751087|P2|Participant Flow|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
149395|NCT01751087|P1|Participant Flow|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
149396|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
149397|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
149398|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
149399|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
149400|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
149401|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
149402|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
149403|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
149404|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
149405|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
149406|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
149407|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
149408|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
149409|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
149410|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
149411|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
149444|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
149412|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
149413|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
149414|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
149415|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
149416|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
149417|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
149418|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
149419|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
149420|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
149421|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
149422|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
149423|NCT01751087|E3|Reported Event|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
149424|NCT01751087|E2|Reported Event|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
149425|NCT01751087|E1|Reported Event|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
149426|NCT01751022|B4|Baseline|Total|Total of all reporting groups
149427|NCT01751022|B3|Baseline|Attain Performa LV Lead Model 4598|Subjects with an attempted Attain Performa LV Lead Model 4598 implant
149428|NCT01751022|B2|Baseline|Attain Performa LV Lead Model 4398|Subjects with an attempted Attain Performa LV Lead Model 4398 implant
149429|NCT01751022|B1|Baseline|Attain Performa LV Lead Model 4298|Subjects with an attempted Attain Performa LV Lead Model 4298 implant
149430|NCT01751022|P3|Participant Flow|Model 4598|Patients with an implant attempt for the Attain Performa Lead Model 4598
149431|NCT01751022|P2|Participant Flow|Model 4398|Patients with an implant attempt for the Attain Performa Lead Model 4398
149432|NCT01751022|P1|Participant Flow|Model 4298|Patients with an implant attempt for the Attain Performa Lead Model 4298
149433|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted successfully.
149434|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted successfully.
149435|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted successfully.
149436|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit.
149437|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit.
149438|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit.
149439|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted successfully.
149440|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted successfully.
149441|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted successfully.
149442|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
149445|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with an attempted Attain Performa LV Lead Model 4598 implant
149451|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted and at least one valid pacing threshold at any LV lead pacing polarity measured at the 6 month.
149452|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted and at least one valid pacing threshold at any LV lead pacing polarity measured at the 6 month follow-up visit.
149453|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted and at least one valid pacing threshold at any LV lead pacing polarity measured at the 6 month follow-up visit.
149454|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
149455|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
149456|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
149457|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with an attempted Attain Performa LV Lead Model 4598 implant.
149458|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with an attempted Attain Performa LV Lead Model 4398 implant.
149459|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with an attempted Attain Performa LV Lead Model 4298 implant.
149460|NCT01751022|E3|Reported Event|Attain Performa LV Lead Model 4598|Subjects with an attempted Attain Performa LV Lead Model 4598 implant. Results as showed in the Model 4598 PMA-S Clinical Report Version 1, 29AUG2014.
149461|NCT01751022|E2|Reported Event|Attain Performa LV Lead Model 4398|Subjects with an attempted Attain Performa LV Lead Model 4398 implant. Results as showed in the Model 4398 PMA-S Clinical Report Version 3, 03SEP2014.
149462|NCT01751022|E1|Reported Event|Attain Performa LV Lead Model 4298|Subjects with an attempted Attain Performa LV Lead Model 4298 implant. Results as showed in the Model 4298 PMA-S Clinical Report Version 1, 27MAR2014.
149463|NCT01750931|B1|Baseline|GSK-meloxicam 15 mg + Mobic-meloxicam 15 mg|In each period of the study, participants received a single oral dose of test (GSK-meloxicam 15 mg tablet) or reference (Mobic-meloxicam 15 mg tablet) product as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period. A washout period of 14 days was maintained between the dosing of each period.
149464|NCT01750931|P2|Participant Flow|Mobic-meloxicam Then GSK-meloxicam|In this period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) followed by test (GSK-meloxicam 15 mg tablet) product as per the randomization schedule with 240 milliliters (mL) of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 ante meridiem (am) to 08:56 am in each study period. A washout period of 14 days was maintained between the dosing of each period.
149465|NCT01750931|P1|Participant Flow|GSK-meloxicam Then Mobic-meloxicam|In this period of the study, participants received a single oral dose of test (GSK-meloxicam 15 mg tablet) followed by reference (Mobic-meloxicam 15 mg tablet) product as per the randomization schedule with 240 milliliters (mL) of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 ante meridiem (am) to 08:56 am in each study period. A washout period of 14 days was maintained between the dosing of each period.
149466|NCT01750931|O2|Outcome|Mobic-meloxicam 15 mg|In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
149467|NCT01750931|O1|Outcome|GSK-meloxicam 15 mg|In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
149468|NCT01750931|O2|Outcome|Mobic-meloxicam 15 mg|In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
149469|NCT01750931|O1|Outcome|GSK-meloxicam 15 mg|In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
149470|NCT01750931|O2|Outcome|Mobic-meloxicam 15 mg|In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
149471|NCT01750931|O1|Outcome|GSK-meloxicam 15 mg|In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
149472|NCT01750931|O2|Outcome|Mobic-meloxicam 15 mg|In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
149561|NCT01750281|P3|Participant Flow|Selumetinib 75 mg BD + Docetaxel 75 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
149473|NCT01750931|O1|Outcome|GSK-meloxicam 15 mg|In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
149474|NCT01750931|O2|Outcome|Mobic-meloxicam 15 mg|In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
149475|NCT01750931|O1|Outcome|GSK-meloxicam 15 mg|In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
149476|NCT01750931|O2|Outcome|Mobic-meloxicam 15 mg|In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
149477|NCT01750931|O1|Outcome|GSK-meloxicam 15 mg|In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
149478|NCT01750931|O2|Outcome|Mobic-meloxicam 15 mg|In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
149479|NCT01750931|O1|Outcome|GSK-meloxicam 15 mg|In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
149480|NCT01750931|E2|Reported Event|Mobic-meloxicam 15 mg|In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
149481|NCT01750931|E1|Reported Event|GSK-meloxicam 15 mg|In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
149482|NCT01750840|B1|Baseline|Stimulation Group|All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems.
149483|NCT01750840|P1|Participant Flow|Stimulation Group|All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems.
149484|NCT01750840|O1|Outcome|Stimulation Group|"All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems.~Biomet EBI Bone Healing System: A pulsed electromagnetic fields electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 3-10 hours per day with a recommended use of 10 hours per day.~Biomet Orthopak Non-Invasive Bone Growth Stimulator: A capacitive coupling electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 24 hours per day.~Biomet SpinalPak Non-Invasive Spine Fusion Stimulator System: A capacitive coupling electrical stimulation device used as an adjunctive treatment to lumbar spinal fusion. Designed to be used for 24 hours per day."
149485|NCT01750840|O1|Outcome|Stimulation Group|All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems.
149486|NCT01750840|E1|Reported Event|Stimulation Group|All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems.
149487|NCT01750684|B3|Baseline|Total|Total of all reporting groups
149488|NCT01750684|B2|Baseline|AC105|"Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~AC105"
149489|NCT01750684|B1|Baseline|Placebo|"Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~Placebo"
149490|NCT01750684|P2|Participant Flow|AC105|"Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~AC105"
149491|NCT01750684|P1|Participant Flow|Placebo|"Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~Placebo"
149492|NCT01750684|O2|Outcome|AC105|"Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~AC105"
149493|NCT01750684|O1|Outcome|Placebo|"Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~Placebo"
149494|NCT01750684|E2|Reported Event|AC105|"Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~AC105"
149495|NCT01750684|E1|Reported Event|Placebo|"Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~Placebo"
149496|NCT01750502|B3|Baseline|Total|Total of all reporting groups
149497|NCT01750502|B2|Baseline|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
149498|NCT01750502|B1|Baseline|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
149499|NCT01750502|P2|Participant Flow|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
149500|NCT01750502|P1|Participant Flow|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
149501|NCT01750502|O2|Outcome|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
149502|NCT01750502|O1|Outcome|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
149503|NCT01750502|O2|Outcome|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
149504|NCT01750502|O1|Outcome|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
149505|NCT01750502|O3|Outcome|5 Minutes After the Opening of the Balloon|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
149506|NCT01750502|O2|Outcome|After Surgery 5 Minutes|Participants, who are diagnosed as coronary-artery-disease with acute coronary syndromes or stable ischemic heart disease,they Were undergoing PCI.
149507|NCT01750502|O1|Outcome|Before Surgery 5 Minutes|Participants, who are diagnosed as coronary-artery-disease with acute coronary syndromes or stable ischemic heart disease,they Were undergoing PCI.
149508|NCT01750502|O2|Outcome|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
149509|NCT01750502|O1|Outcome|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
149510|NCT01750502|E2|Reported Event|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
149511|NCT01750502|E1|Reported Event|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
149512|NCT01750398|B1|Baseline|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
149513|NCT01750398|P1|Participant Flow|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
149562|NCT01750281|P2|Participant Flow|Selumetinib 75 mg BD + Docetaxel 60 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
149563|NCT01750281|P1|Participant Flow|Placebo + Docetaxel 75 mg/m^2|Oral placebo BD and intravenous docetaxel on day 1 of every 21 day cycle
149564|NCT01750281|O3|Outcome|Selumetinib 75 mg BD + Docetaxel 75 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
149565|NCT01750281|O2|Outcome|Selumetinib 75 mg BD + Docetaxel 60 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
149566|NCT01750281|O1|Outcome|Placebo + Docetaxel 75 mg/m^2|Oral placebo BD and intravenous docetaxel on day 1 of every 21 day cycle
149514|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
149515|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
149516|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
149517|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
149518|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
149519|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
149520|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
149567|NCT01750281|O3|Outcome|Selumetinib 75 mg BD + Docetaxel 75 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
149568|NCT01750281|O2|Outcome|Selumetinib 75 mg BD + Docetaxel 60 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
149569|NCT01750281|O1|Outcome|Placebo + Docetaxel 75 mg/m^2|Oral placebo BD and intravenous docetaxel on day 1 of every 21 day cycle
149639|NCT01749982|E2|Reported Event|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily~Choline bitartrate"
149521|NCT01750398|E1|Reported Event|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
149522|NCT01750346|B4|Baseline|Total|Total of all reporting groups
149523|NCT01750346|B3|Baseline|Placebo|Participants in the Placebo arm received the placebo.
149524|NCT01750346|B2|Baseline|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
149525|NCT01750346|B1|Baseline|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
149526|NCT01750346|P3|Participant Flow|Placebo|Participants in the Placebo arm received the placebo.
149527|NCT01750346|P2|Participant Flow|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
149528|NCT01750346|P1|Participant Flow|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
149529|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
149530|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
149531|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
149532|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
149533|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
149534|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
149535|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
149536|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
149537|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
149538|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
149539|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
149540|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
149541|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
149542|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
149543|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
149544|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
149545|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
149546|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
149547|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
149548|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
149549|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
149550|NCT01750346|E3|Reported Event|Placebo|"Participants in the Placebo arm received the placebo.~Topical acetyl hexapeptide-8"
149551|NCT01750346|E2|Reported Event|0.025% AH-8|"Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.~Topical acetyl hexapeptide-8"
149552|NCT01750346|E1|Reported Event|0.05% AH-8|"Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.~Topical acetyl hexapeptide-8"
149553|NCT01750294|B1|Baseline|Chlorthalidone|Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)
149554|NCT01750294|P1|Participant Flow|Chlorthalidone|Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)
149555|NCT01750294|O1|Outcome|Chlorthalidone|Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)
149556|NCT01750294|E1|Reported Event|Chlorthalidone|Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)
149557|NCT01750281|B4|Baseline|Total|Total of all reporting groups
149558|NCT01750281|B3|Baseline|Selumetinib 75 mg BD + Docetaxel 75 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
149559|NCT01750281|B2|Baseline|Selumetinib 75 mg BD + Docetaxel 60 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
149570|NCT01750281|E3|Reported Event|Selumetinib 75 mg BD + Docetaxel 75 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
149571|NCT01750281|E2|Reported Event|Selumetinib 75 mg BD + Docetaxel 60 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
149572|NCT01750281|E1|Reported Event|Placebo + Docetaxel 75 mg/m^2|Oral placebo BD and intravenous docetaxel on day 1 of every 21 day cycle
149573|NCT01750255|B3|Baseline|Total|Total of all reporting groups
149574|NCT01750255|B2|Baseline|Pharmaceutical Care|Patients and families will be provided with verbal and written information and education about mental health and bipolar disorder. Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment. Pharmaceutical Care: Patients and their families will be provided with verbal and written information and education about mental health and bipolar disorder.
149575|NCT01750255|B1|Baseline|Control|"There is no placebo treatment, and after randomization, patients were informed of their group assignments. The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.~Education: The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families."
149576|NCT01750255|P2|Participant Flow|Intervention Group: the Dader Method for Pharmaceutical Care|The Dader Method for pharmaceutical care is a systematic process developed by the Research Group of Pharmaceutical Care at the University of Granada, Spain [16]. The intervention is based on the use of pharmacotherapy records, evaluation of an assessment form that includes BD-I and the drugs used to treat this medical problem, and their assessment on a specific date. This assessment is used to identify: (1) any potential or actual patient health outcomes that are not consistent with the objectives of pharmacotherapy and are associated with the use of medicines (negative outcomes associated with medication (NOM)); and (2) situations in which the use of medicines caused or may cause the appearance of a NOM (drug-related problems (DRP)) [14]. Once the relevant problems are identified, the necessary interventions to patients or to physicians are carried out to solve the identified NOM and are followed by a subsequent assessment of the achieved outcomes.
149577|NCT01750255|P1|Participant Flow|Control: Usual Care (Routine Dispensing), Verbal and Written|Because there is no blinding, there is no ‘placebo’ treatment. Patients who meet the inclusion criteria will be informed about the study and they will be registered after their signed authorization. The control group (patients and their families) will receive usual care as well as verbal and written information provided by the pharmacist (routine dispensing, including oral counseling regarding drugs). The written material is about mental health (MH) and BD, with information focusing on the importance of adhering to pharmacological and non-pharmacological interventions to achieve treatment goals. Randomization will take place during week zero (baseline) and patients will meet again with the pharmacist every three months (3, 6, 9, and 12 months). At each appointment, variables related to the primary (number of hospitalizations, emergency service consultations, unscheduled outpatient visits) and secondary outcomes (effectiveness, safety, adherence, and quality of life) will be assessed.
149578|NCT01750255|O2|Outcome|Intervention|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
149579|NCT01750255|O1|Outcome|Control|The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
149580|NCT01750255|O2|Outcome|Intervention|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
149581|NCT01750255|O1|Outcome|Control|The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
149636|NCT01749982|O1|Outcome|Placebo|"Placebo tablets~Placebo"
149640|NCT01749982|E1|Reported Event|Placebo|"Placebo tablets~Placebo"
149582|NCT01750255|O2|Outcome|Pharmaceutical Care|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
149583|NCT01750255|O1|Outcome|Control|The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
149584|NCT01750255|O2|Outcome|Intervention|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
149585|NCT01750255|O1|Outcome|Control|The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
149586|NCT01750255|O2|Outcome|Intervention|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
149587|NCT01750255|O1|Outcome|Control|The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
149588|NCT01750255|O2|Outcome|Pharmaceutical Care|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
149589|NCT01750255|O1|Outcome|Control|The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
149590|NCT01750255|E2|Reported Event|Pharmaceutical Care|Patients and families will be provided with verbal and written information and education about mental health and bipolar disorder. Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
149591|NCT01750255|E1|Reported Event|Control|"The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.~Education: The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure d"
149637|NCT01749982|E4|Reported Event|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily~Choline bitartrate + Betaine"
149638|NCT01749982|E3|Reported Event|Betaine|"Betaine 1000 mg by mouth daily~Betaine"
149592|NCT01750242|B1|Baseline|Subjects With Advanced Parkinson's Disease|Subjects with advanced Parkinson's Disease implanted with Medtronic DBS system and with documented improvement of at least 35% on UPDRS III from baseline preoperative off medication to post-DBS implant stimulation on/medication off.
149593|NCT01750242|P1|Participant Flow|PD Patients Implanted With DBS System|Subjects implanted with Medtronic DBS system for the treatment of Parkinson's disease with leads in the subthalamic nucleus who consented for the study.
149594|NCT01750242|O1|Outcome|Subjects With Advanced Parkinson's Disease|Subjects with advanced Parkinson's Disease implanted with Medtronic DBS system and with documented improvement of at least 35% on UPDRS III from baseline preoperative off medication to post-DBS implant stimulation on/medication off.
149595|NCT01750242|O1|Outcome|PD Patients Implanted With DBS System|Subjects implanted with Medtronic DBS system for the treatment of Parkinson's disease with leads in the subthalamic nucleus and with readable images.
149596|NCT01750242|E1|Reported Event|Subjects With Advanced Parkinson's Disease|The study protocol did not require safety data to be collected for the study.
149597|NCT01750229|B1|Baseline|Randomized Phase Subjects|Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
149598|NCT01750229|P1|Participant Flow|All Randomized Subjects|Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
149599|NCT01750229|O4|Outcome|5882 Hz|Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
149600|NCT01750229|O3|Outcome|3030 Hz|Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
149601|NCT01750229|O2|Outcome|1200 Hz|Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
149602|NCT01750229|O1|Outcome|Sham|Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
149603|NCT01750229|E4|Reported Event|5882 Hz|Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
149604|NCT01750229|E3|Reported Event|3030 Hz|Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
149605|NCT01750229|E2|Reported Event|1200 Hz|Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
149606|NCT01750229|E1|Reported Event|Sham|Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
149607|NCT01750086|B3|Baseline|Total|Total of all reporting groups
149608|NCT01750086|B2|Baseline|Alendronate 70mg Weekly x 8 Weeks|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
149609|NCT01750086|B1|Baseline|Denosumab 60mg Subcutaneous Injection|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
149610|NCT01750086|P2|Participant Flow|Alendronate 70mg Weekly x 8 Weeks|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
149611|NCT01750086|P1|Participant Flow|Denosumab 60mg Subcutaneous Injection|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
149612|NCT01750086|O2|Outcome|Alendronate 70mg Weekly x 8 Weeks|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
149613|NCT01750086|O1|Outcome|Denosumab 60mg Subcutaneous Injection|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
149614|NCT01750086|E2|Reported Event|Alendronate 70mg Weekly x 8 Weeks|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
149615|NCT01750086|E1|Reported Event|Denosumab 60mg Subcutaneous Injection|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
149616|NCT01749982|B5|Baseline|Total|Total of all reporting groups
149617|NCT01749982|B4|Baseline|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily~Choline bitartrate + Betaine"
149618|NCT01749982|B3|Baseline|Betaine|"Betaine 1000 mg by mouth daily~Betaine"
149619|NCT01749982|B2|Baseline|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily~Choline bitartrate"
149620|NCT01749982|B1|Baseline|Placebo|"Placebo tablets~Placebo"
149621|NCT01749982|P4|Participant Flow|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily~Choline bitartrate + Betaine"
149622|NCT01749982|P3|Participant Flow|Betaine|"Betaine 1000 mg by mouth daily~Betaine"
149623|NCT01749982|P2|Participant Flow|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily~Choline bitartrate"
149624|NCT01749982|P1|Participant Flow|Placebo|"Placebo tablets~Placebo"
149625|NCT01749982|O4|Outcome|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily~Choline bitartrate + Betaine"
149626|NCT01749982|O3|Outcome|Betaine|"Betaine 1000 mg by mouth daily~Betaine"
149627|NCT01749982|O2|Outcome|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily~Choline bitartrate"
149628|NCT01749982|O1|Outcome|Placebo|"Placebo tablets~Placebo"
149629|NCT01749982|O4|Outcome|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily~Choline bitartrate + Betaine"
149630|NCT01749982|O3|Outcome|Betaine|"Betaine 1000 mg by mouth daily~Betaine"
149631|NCT01749982|O2|Outcome|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily~Choline bitartrate"
149632|NCT01749982|O1|Outcome|Placebo|"Placebo tablets~Placebo"
149633|NCT01749982|O4|Outcome|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily~Choline bitartrate + Betaine"
149634|NCT01749982|O3|Outcome|Betaine|"Betaine 1000 mg by mouth daily~Betaine"
149635|NCT01749982|O2|Outcome|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily~Choline bitartrate"
149641|NCT01749956|B1|Baseline|FOLFOX6/Aflibercept/Radation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
149642|NCT01749956|P1|Participant Flow|FOLFOX6/Aflibercept/Radation/Surgery|"Preoperative Chemoradiation (6 weeks): 5-FU: 225 mg/m2 per day by intravenous continuous infusion (IV), Days 1-42; Radiation: 50.4 Gy (1.8 Gy/day) Mon-Fri, Weeks 1 thru 6; Aflibercept: 4 mg/ kg, via IV infusion, Days 1 and 15.~Surgery (6 weeks from last dose of aflibercep): abdominoperineal or low anterior resection with total mesorectal excision, per standard treatment guidelines.~Postoperative Chemotherapy and Aflibercept: Aflibercept (administered first): 4 mg/kg IV for approximately 1 hour; Days 1 and 15 of each 28-day cycle; Modified FOLFOX6: Leucovorin: 400 mg/m2 as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle; Oxaliplatin: 85 mg/m2 IV as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle; 5-FU: 400-mg/m2 bolus for 2 to 4 minutes followed by 2400 mg/m2 for 46 hours on Days 1 and 15 of each cycle."
149643|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radiation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
149644|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radiation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
149645|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
149646|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
149647|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radiation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
149648|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radiation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
149649|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radiation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
149650|NCT01749956|E1|Reported Event|FOLFOX6/Aflibercept/Radiation/Surgery|"Preoperative Chemoradiation: 5-FU: 225 mg/m2 per day by intravenous continuous infusion (IVCI), Days 1 thru 42; Radiation: 50.4 Gy (1.8 Gy/day or 28 fractions) Mon thru Fri, Weeks 1 thru 6; Aflibercept: 4 mg/ kg, via IV infusion, Days 1 and 15.~Surgery: Patients will undergo abdominoperineal or low anterior resection with total mesorectal excision, per standard treatment guidelines.~Postoperative Chemotherapy and Aflibercept Treatments:~Aflibercept (administered first): 4 mg/kg IV for approximately 1 hour (no more than 2 hours) on Days 1 and 15 of each cycle.~Modified FOLFOX6:~Leucovorin: 400 mg/m2 as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle.~Oxaliplatin: 85 mg/m2 IV as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle.~5-FU: 400-mg/m2 bolus for 2 to 4 minutes followed by 2400 mg/m2 for 46 hours on Days 1 and 15 of each cycle.~Radiation~Aflibercept~Surgery: Abdominoperineal or low anterior resectio"
149651|NCT01749800|B4|Baseline|Total|Total of all reporting groups
149652|NCT01749800|B3|Baseline|Armeo Spring + Sham GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with sham GVS. Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. Sham stimulation is delivered by connecting the subject to a device by A-M Systems, but the device is not active.~Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.~Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
149653|NCT01749800|B2|Baseline|Armeo Spring +GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with galvanic vestibular stimulation (GVS). Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. GVS is delivered using a device by A-M Systems.~GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.~Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
149654|NCT01749800|B1|Baseline|Cognitive Test With/Without GVS|"Subjects with attention span deficits and no significant motor impairments undergo solely a cognitive test. The test is carried out in multiple trials. For some of the trials (randomly selected), subjects receive galvanic vestibular stimulation (GVS). For other trials, subjects received sham GVS. GVS is delivered using a device by A-M Systems.~GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.~Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active."
149655|NCT01749800|P3|Participant Flow|Armeo Spring + Sham GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with sham GVS. Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. Sham stimulation is delivered by connecting the subject to a device by A-M Systems, but the device is not active.~Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.~Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
149656|NCT01749800|P2|Participant Flow|Armeo Spring +GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with galvanic vestibular stimulation (GVS). Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. GVS is delivered using a device by A-M Systems.~GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.~Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
149657|NCT01749800|P1|Participant Flow|Cognitive Test With/Without GVS|"Subjects with attention span deficits and no significant motor impairments undergo solely a cognitive test. The test is carried out in multiple trials. For some of the trials (randomly selected), subjects receive galvanic vestibular stimulation (GVS). For other trials, subjects received sham GVS. GVS is delivered using a device by A-M Systems.~GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.~Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active."
149658|NCT01749800|O3|Outcome|Armeo Spring + Sham GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with sham GVS. Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. Sham stimulation is delivered by connecting the subject to a device by A-M Systems, but the device is not active.~Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.~Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
149659|NCT01749800|O2|Outcome|Armeo Spring +GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with galvanic vestibular stimulation (GVS). Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. GVS is delivered using a device by A-M Systems.~GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.~Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
149660|NCT01749800|O1|Outcome|Cognitive Test With/Without GVS|"Subjects with attention span deficits and no significant motor impairments undergo solely a cognitive test. The test is carried out in multiple trials. For some of the trials (randomly selected), subjects receive galvanic vestibular stimulation (GVS). For other trials, subjects received sham GVS. GVS is delivered using a device by A-M Systems.~GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.~Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active."
149661|NCT01749800|E3|Reported Event|Armeo Spring + Sham GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with sham GVS. Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. Sham stimulation is delivered by connecting the subject to a device by A-M Systems, but the device is not active.~Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.~Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
149662|NCT01749800|E2|Reported Event|Armeo Spring +GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with galvanic vestibular stimulation (GVS). Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. GVS is delivered using a device by A-M Systems.~GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.~Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
149663|NCT01749800|E1|Reported Event|Cognitive Test With/Without GVS|"Subjects with attention span deficits and no significant motor impairments undergo solely a cognitive test. The test is carried out in multiple trials. For some of the trials (randomly selected), subjects receive galvanic vestibular stimulation (GVS). For other trials, subjects received sham GVS. GVS is delivered using a device by A-M Systems.~GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.~Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active."
149664|NCT01749735|B3|Baseline|Total|Total of all reporting groups
149665|NCT01749735|B2|Baseline|Armeo Training With Sham tDCS|"Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
149666|NCT01749735|B1|Baseline|Armeo Training With Continuous tDCS|"Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
149667|NCT01749735|P2|Participant Flow|Armeo Training With Sham tDCS|"Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
149668|NCT01749735|P1|Participant Flow|Armeo Training With Continuous tDCS|"Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
149669|NCT01749735|O2|Outcome|Armeo Training With Sham tDCS|"Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
149670|NCT01749735|O1|Outcome|Armeo Training With Continuous tDCS|"Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
149671|NCT01749735|O2|Outcome|Armeo Training With Sham tDCS|"Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
149707|NCT01749410|O1|Outcome|All Participants|Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
149708|NCT01749410|E1|Reported Event|All Participants|Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
149672|NCT01749735|O1|Outcome|Armeo Training With Continuous tDCS|"Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
149673|NCT01749735|E2|Reported Event|Armeo Training With Sham tDCS|"Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
149674|NCT01749735|E1|Reported Event|Armeo Training With Continuous tDCS|"Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
149675|NCT01749631|B1|Baseline|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
149676|NCT01749631|P1|Participant Flow|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
149677|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
149678|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
149679|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
149680|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
149681|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
149682|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
149683|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
149684|NCT01749631|E1|Reported Event|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
149685|NCT01749605|B3|Baseline|Total|Total of all reporting groups
149686|NCT01749605|B2|Baseline|Ciprofloxacin 250 mg|ciprofloxacin 250 mg BID x 3 days
149687|NCT01749605|B1|Baseline|Nitrofurantoin 100 mg|Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days
149688|NCT01749605|P2|Participant Flow|Ciprofloxacin 250 mg|ciprofloxacin 250 mg BID x 3 days
149689|NCT01749605|P1|Participant Flow|Nitrofurantoin 100 mg|Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days
149690|NCT01749605|O2|Outcome|Ciprofloxacin 250 mg|ciprofloxacin 250 mg BID x 3 days
149691|NCT01749605|O1|Outcome|Nitrofurantoin 100 mg|Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days
149692|NCT01749605|E2|Reported Event|Ciprofloxacin 250 mg|ciprofloxacin 250 mg BID x 3 days
149693|NCT01749605|E1|Reported Event|Nitrofurantoin 100 mg|Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days
149694|NCT01749501|B3|Baseline|Total|Total of all reporting groups
149695|NCT01749501|B2|Baseline|Placebo|Placebo: Normal saline same amt as 0.6mg/kg of study drug
149696|NCT01749501|B1|Baseline|Rocuronium|"0.6 mg/kg once~Rocuronium: 0.6 mg/Kg once"
149697|NCT01749501|P2|Participant Flow|Placebo|Placebo: Normal saline same amt as 0.6mg/kg of study drug
149698|NCT01749501|P1|Participant Flow|Rocuronium|"0.6 mg/kg once~Rocuronium: 0.6 mg/Kg once"
149699|NCT01749501|O2|Outcome|Placebo|Placebo: Normal saline same amt as 0.6mg/kg of study drug
149700|NCT01749501|O1|Outcome|Rocuronium|"0.6 mg/kg once~Rocuronium: 0.6 mg/Kg once"
149701|NCT01749501|O2|Outcome|Placebo|Placebo: Normal saline same amt as 0.6mg/kg of study drug
149702|NCT01749501|O1|Outcome|Rocuronium|"0.6 mg/kg once~Rocuronium: 0.6 mg/Kg once"
149703|NCT01749501|E2|Reported Event|Placebo|Placebo: Normal saline same amt as 0.6mg/kg of study drug
149704|NCT01749501|E1|Reported Event|Rocuronium|"0.6 mg/kg once~Rocuronium: 0.6 mg/Kg once"
149705|NCT01749410|B1|Baseline|All Participants|Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
149706|NCT01749410|P1|Participant Flow|All Participants|Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
149710|NCT01748955|B2|Baseline|Paroxetine CR|"Participants will receive Paroxetine CR for 8 weeks.~Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment."
149711|NCT01748955|B1|Baseline|Bupropion|"Participants will receive bupropion XL for 8 weeks.~Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment."
149712|NCT01748955|P2|Participant Flow|Paroxetine CR|"Participants will receive Paroxetine CR for 8 weeks.~Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment."
149713|NCT01748955|P1|Participant Flow|Bupropion|"Participants will receive bupropion XL for 8 weeks.~Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment."
149714|NCT01748955|O2|Outcome|Paroxetine CR|"Participants will receive Paroxetine CR for 8 weeks.~Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment."
149715|NCT01748955|O1|Outcome|Bupropion|"Participants will receive bupropion XL for 8 weeks.~Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment."
149716|NCT01748955|O2|Outcome|Paroxetine CR|"Participants will receive Paroxetine CR for 8 weeks.~Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment."
149717|NCT01748955|O1|Outcome|Bupropion|"Participants will receive bupropion XL for 8 weeks.~Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment."
149718|NCT01748955|E2|Reported Event|Paroxetine CR|"Participants will receive Paroxetine CR for 8 weeks.~Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment."
149719|NCT01748955|E1|Reported Event|Bupropion|"Participants will receive bupropion XL for 8 weeks.~Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment."
149720|NCT01748942|B3|Baseline|Total|Total of all reporting groups
149721|NCT01748942|B2|Baseline|Arm II (Control)|"Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
149722|NCT01748942|B1|Baseline|Arm I (Treatment)|"Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
149723|NCT01748942|P2|Participant Flow|Arm II (Control)|"Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
149724|NCT01748942|P1|Participant Flow|Arm I (Treatment)|"Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
149725|NCT01748942|O2|Outcome|Arm II (Control)|"Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
149726|NCT01748942|O1|Outcome|Arm I (Treatment)|"Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
149727|NCT01748942|O2|Outcome|Arm II (Control)|"Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
149728|NCT01748942|O1|Outcome|Arm I (Treatment)|"Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
149729|NCT01748942|O2|Outcome|Arm II (Control)|"Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
149730|NCT01748942|O1|Outcome|Arm I (Treatment)|"Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
149731|NCT01748942|O2|Outcome|Arm II (Control)|"Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
149732|NCT01748942|O1|Outcome|Arm I (Treatment)|"Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
149797|NCT01748799|O4|Outcome|Sequence 4|Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex
149733|NCT01748942|O2|Outcome|Arm II (Control)|"Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
149734|NCT01748942|O1|Outcome|Arm I (Treatment)|"Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
149735|NCT01748942|O2|Outcome|Arm II (Control)|"Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
149736|NCT01748942|O1|Outcome|Arm I (Treatment)|"Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
149737|NCT01748942|O2|Outcome|Arm II (Control)|"Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
149738|NCT01748942|O1|Outcome|Arm I (Treatment)|"Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
149739|NCT01748942|O2|Outcome|Arm II (Control)|"Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
149740|NCT01748942|O1|Outcome|Arm I (Treatment)|"Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
149741|NCT01748942|E2|Reported Event|Arm II (Control)|"Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
149742|NCT01748942|E1|Reported Event|Arm I (Treatment)|"Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.~Dexamethasone: Given IV~Dexamethasone: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Transoral Robotic Surgery: Undergo TORS"
149743|NCT01748916|B1|Baseline|All Groups (Average)|All study participants
149744|NCT01748916|P6|Participant Flow|Carrot-Tomato-Papaya|"Test meals were consumed in the following order: 1. Carrot 2. Tomato 3. Papaya~Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
149745|NCT01748916|P5|Participant Flow|Carrot-Papaya-Tomato|"Test meals were consumed in the following order: 1. Carrot 2. Papaya 3. Tomato~Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
149746|NCT01748916|P4|Participant Flow|Tomato-Carrot-Papaya|"Test meals were consumed in the following order: 1. Tomato 2. Carrot 3. Papaya~Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
149747|NCT01748916|P3|Participant Flow|Tomato-Papaya-Carrot|"Test meals were consumed in the following order: 1. Tomato 2. Papaya 3. Carrot~Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
149748|NCT01748916|P2|Participant Flow|Papaya-Tomato-Carrot|"Test meals were consumed in the following order: 1. Papaya 2. Tomato 3. Carrot~Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
149749|NCT01748916|P1|Participant Flow|Papaya-Carrot-Tomato|"Test meals were consumed in the following order: 1. Papaya 2. Carrot 3. Tomato.~Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
149750|NCT01748916|O5|Outcome|Lycopene Absorption From Tomato|
149751|NCT01748916|O4|Outcome|Lycopene Absorption From Papaya|
149752|NCT01748916|O3|Outcome|Beta-Carotene Absorption From Carrot|
149753|NCT01748916|O2|Outcome|Beta-Carotene Absorption From Tomato|
149754|NCT01748916|O1|Outcome|Beta-Carotene Absorption From Papaya|
149755|NCT01748916|E1|Reported Event|All Groups|All groups in study
149756|NCT01748890|B1|Baseline|Sonoelastography|"Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.~Sonoelastography: Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness."
149757|NCT01748890|P1|Participant Flow|Sonoelastography|"Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.~Sonoelastography: Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness."
149758|NCT01748890|O1|Outcome|Sonoelastography|"Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.~Sonoelastography: Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness."
149759|NCT01748890|E1|Reported Event|Sonoelastography|"Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.~Sonoelastography: Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness."
149760|NCT01748799|B9|Baseline|Total|Total of all reporting groups
149761|NCT01748799|B8|Baseline|Sequence 8|Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
149762|NCT01748799|B7|Baseline|Sequence 7|Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex
149763|NCT01748799|B6|Baseline|Sequence 6|Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex
149764|NCT01748799|B5|Baseline|Sequence 5|Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo
149765|NCT01748799|B4|Baseline|Sequence 4|Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex
149766|NCT01748799|B3|Baseline|Sequence 3|Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex
149767|NCT01748799|B2|Baseline|Sequence 2|Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo
149768|NCT01748799|B1|Baseline|Sequence 1|Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo
149769|NCT01748799|P8|Participant Flow|Sequence 8|Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
149770|NCT01748799|P7|Participant Flow|Sequence 7|Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex
149771|NCT01748799|P6|Participant Flow|Sequence 6|Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex
149772|NCT01748799|P5|Participant Flow|Sequence 5|Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo
149773|NCT01748799|P4|Participant Flow|Sequence 4|Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex
149774|NCT01748799|P3|Participant Flow|Sequence 3|Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex
149775|NCT01748799|P2|Participant Flow|Sequence 2|Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo
149776|NCT01748799|P1|Participant Flow|Sequence 1|Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo
149777|NCT01748799|O8|Outcome|Smoke as Usual StP|Smoke as usual condition corresponding to Self-titrated Placebo
149778|NCT01748799|O7|Outcome|Self-titrated Placebo|Participants were requested to abstain from using cannabis and self-titrate dosages of placebo (up to 40 sprays per day) during this condition. Each abstinence condition was followed by a smoke as usual condition (SAU).
149779|NCT01748799|O6|Outcome|Smoke as Usual FP|Smoke as usual condition corresponding to Fixed Placebo
149780|NCT01748799|O5|Outcome|Fixed Dose Placebo|Participants were requested to abstain from using cannabis and administer a fixed dose of placebo daily (40 sprays per day). Each abstinence condition was followed by a smoke as usual condition (SAU).
149781|NCT01748799|O4|Outcome|Smoke as Usual StS|Smoke as usual condition corresponding to Self-titrated Sativex
149782|NCT01748799|O3|Outcome|Self-titrated Sativex|Participants were requested to abstain from using cannabis and self-titrate dosages of Sativex (up to 40 sprays per day) during this condition. Each abstinence condition was followed by a smoke as usual condition (SAU).
149783|NCT01748799|O2|Outcome|Smoke as Usual FS|Smoke as usual condition corresponding to Fixed Sativex
149784|NCT01748799|O1|Outcome|Fixed Dose Sativex|Participants were requested to abstain from using cannabis and take a fixed dose of Sativex during this condition (40 sprays per day). Each abstinence condition was followed by a smoke as usual condition (SAU).
149785|NCT01748799|O8|Outcome|Sequence 8|Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
149786|NCT01748799|O7|Outcome|Sequence 7|Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex
149787|NCT01748799|O6|Outcome|Sequence 6|Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex
149788|NCT01748799|O5|Outcome|Sequence 5|Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo
149789|NCT01748799|O4|Outcome|Sequence 4|Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex
149790|NCT01748799|O3|Outcome|Sequence 3|Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex
149791|NCT01748799|O2|Outcome|Sequence 2|Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo
149792|NCT01748799|O1|Outcome|Sequence 1|Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo
149793|NCT01748799|O8|Outcome|Sequence 8|Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
149794|NCT01748799|O7|Outcome|Sequence 7|Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex
149795|NCT01748799|O6|Outcome|Sequence 6|Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex
149796|NCT01748799|O5|Outcome|Sequence 5|Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo
149798|NCT01748799|O3|Outcome|Sequence 3|Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex
149799|NCT01748799|O2|Outcome|Sequence 2|Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo
149800|NCT01748799|O1|Outcome|Sequence 1|Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo
149801|NCT01748799|E8|Reported Event|Smoke as Usual StP|Smoke as usual condition corresponding to Self-titrated placebo
149802|NCT01748799|E7|Reported Event|Self-titrated Placebo|Participants were requested to abstain from using cannabis and self-titrate dosages of placebo (up to 40 sprays per day) during this condition. Each abstinence condition was followed by a smoke as usual condition (SAU).
149803|NCT01748799|E6|Reported Event|Smoke as Usual FP|Smoke as usual condition corresponding to Fixed placebo
149804|NCT01748799|E5|Reported Event|Fixed Dose Placebo|Participants were requested to abstain from using cannabis and take a fixed dose of placebo during this condition (40 sprays per day). Each abstinence condition was followed by a smoke as usual condition (SAU).
149805|NCT01748799|E4|Reported Event|Smoke as Usual StS|Smoke as usual condition corresponding to Self-titrated Sativex
149806|NCT01748799|E3|Reported Event|Self-titrated Sativex|Participants were requested to abstain from using cannabis and self-titrate dosages of Sativex (up to 40 sprays per day) during this condition. Each abstinence condition was followed by a smoke as usual condition (SAU).
149807|NCT01748799|E2|Reported Event|Smoke as Usual FS|Smoke as usual condition corresponding to Fixed Sativex
149808|NCT01748799|E1|Reported Event|Fixed Dose Sativex|Participants were requested to abstain from using cannabis and take a fixed dose of Sativex during this condition (40 sprays per day). Each abstinence condition was followed by a smoke as usual condition (SAU).
149809|NCT01748760|B3|Baseline|Total|Total of all reporting groups
149810|NCT01748760|B2|Baseline|Treatment as Usual|"Adolescent participants and parents will not receive study intervention~Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning."
149811|NCT01748760|B1|Baseline|CLASP-A Intervention|"Adolescent participants and parents will receive adjunctive psychosocial intervention.~CLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan."
149812|NCT01748760|P2|Participant Flow|Treatment as Usual|"Adolescent participants and parents will not receive study intervention~Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning."
149813|NCT01748760|P1|Participant Flow|CLASP-A Intervention|"Adolescent participants and parents will receive adjunctive psychosocial intervention.~CLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan."
149814|NCT01748760|O2|Outcome|Treatment as Usual|"Adolescent participants and parents will not receive study intervention~Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning."
149815|NCT01748760|O1|Outcome|CLASP-A Intervention|"Adolescent participants and parents will receive adjunctive psychosocial intervention.~CLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan."
149816|NCT01748760|E2|Reported Event|Treatment as Usual|"Adolescent participants and parents will not receive study intervention~Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning."
149817|NCT01748760|E1|Reported Event|CLASP-A Intervention|"Adolescent participants and parents will receive adjunctive psychosocial intervention.~CLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan."
149818|NCT01748695|B1|Baseline|V158866 and Placebo|Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks or vice versa
149819|NCT01748695|P2|Participant Flow|V158866 Followed by Placebo|V158866 450mg once per day for 4 weeks followed by placebo once per day for 4 weeks
149820|NCT01748695|P1|Participant Flow|Placebo Followed by V158866|Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks
149821|NCT01748695|O2|Outcome|V158866|V158866 450mg once per day for 4 weeks
149822|NCT01748695|O1|Outcome|Placebo|Placebo once per day for 4 weeks
149823|NCT01748695|O2|Outcome|V158866|V158866 450mg once per day for 4 weeks
149824|NCT01748695|O1|Outcome|Placebo|Placebo once per day for 4 weeks
149825|NCT01748695|E2|Reported Event|V158866|V158866 450mg once per day for 4 Weeks
149826|NCT01748695|E1|Reported Event|Placebo|Placebo once per day for 4 weeks
149827|NCT01748643|B3|Baseline|Total|Total of all reporting groups
149828|NCT01748643|B2|Baseline|Normal Neuromuscular Blockade, Reversal With Neostigmine|"After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.~normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9."
149829|NCT01748643|B1|Baseline|Deep Neuromuscular Blockade, Reversal With Sugammadex|"a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.~deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9."
149830|NCT01748643|P2|Participant Flow|Normal Neuromuscular Blockade, Reversal With Neostigmine|"After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.~normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9."
149831|NCT01748643|P1|Participant Flow|Deep Neuromuscular Blockade, Reversal With Sugammadex|"a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.~deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9."
149832|NCT01748643|O2|Outcome|Normal Neuromuscular Blockade, Reversal With Neostigmine|"After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.~normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9."
149833|NCT01748643|O1|Outcome|Deep Neuromuscular Blockade, Reversal With Sugammadex|"a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.~deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9."
149834|NCT01748643|O2|Outcome|Normal Neuromuscular Blockade, Reversal With Neostigmine|"After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.~normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9."
149835|NCT01748643|O1|Outcome|Deep Neuromuscular Blockade, Reversal With Sugammadex|"a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.~deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9."
149836|NCT01748643|O2|Outcome|Normal Neuromuscular Blockade, Reversal With Neostigmine|"After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.~normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9."
149837|NCT01748643|O1|Outcome|Deep Neuromuscular Blockade, Reversal With Sugammadex|"a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.~deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9."
149838|NCT01748643|O2|Outcome|Normal Neuromuscular Blockade, Reversal With Neostigmine|"After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.~normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9."
149839|NCT01748643|O1|Outcome|Deep Neuromuscular Blockade, Reversal With Sugammadex|"a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.~deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9."
149878|NCT01748162|O2|Outcome|Oral Control|Short term oral prednisolone. Offered at 1mg/kg daily dosing for symptomatic treatment on as needed basis for three days, but may be modified per managing physician's discretion.
149840|NCT01748643|O2|Outcome|Normal Neuromuscular Blockade, Reversal With Neostigmine|"After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.~normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9."
149841|NCT01748643|O1|Outcome|Deep Neuromuscular Blockade, Reversal With Sugammadex|"a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.~deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9."
149842|NCT01748643|O2|Outcome|Normal Neuromuscular Blockade, Reversal With Neostigmine|"After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.~normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9."
149843|NCT01748643|O1|Outcome|Deep Neuromuscular Blockade, Reversal With Sugammadex|"a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.~deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9."
149844|NCT01748643|E2|Reported Event|Normal Neuromuscular Blockade, Reversal With Neostigmine|"After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.~normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9."
149845|NCT01748643|E1|Reported Event|Deep Neuromuscular Blockade, Reversal With Sugammadex|"a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.~deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9."
149846|NCT01748292|B3|Baseline|Total|Total of all reporting groups
149847|NCT01748292|B2|Baseline|Treat and Extend IVT Ranibizumab|"0.5 mg intravitreal injections (IVT) ranibizumab for 3 consecutive months followed by a treat and extend protocol in which follow-up intervals are increased when there is no clinical and SD-OCT evidence of disease activity by 2-week intervals and patients are treated at every visit. (Comparator arm)~0.5 mg ranibizumab: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit."
149848|NCT01748292|B1|Baseline|Monthly IVT Ranibizumab|"Monthly intravitreal injections (IVT) ranibizumab for 24 months, not less than 21 days apart to not more than 35 days apart~0.5 mg ranibizumab: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit."
149849|NCT01748292|P2|Participant Flow|Treat and Extend IVT Ranibizumab|"0.5 mg intravitreal injections (IVT) ranibizumab for 3 consecutive months followed by a treat and extend protocol in which follow-up intervals are increased when there is no clinical and SD-OCT evidence of disease activity by 2-week intervals and patients are treated at every visit. (Comparator arm)~0.5 mg ranibizumab: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit."
149850|NCT01748292|P1|Participant Flow|Monthly IVT Ranibizumab|"Monthly intravitreal injections (IVT) ranibizumab for 24 months, not less than 21 days apart to not more than 35 days apart~0.5 mg ranibizumab: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit."
149851|NCT01748292|O2|Outcome|Treat and Extend IVT Ranibizumab|"0.5 mg intravitreal injections (IVT) ranibizumab for 3 consecutive months followed by a treat and extend protocol in which follow-up intervals are increased when there is no clinical and SD-OCT evidence of disease activity by 2-week intervals and patients are treated at every visit. (Comparator arm)~0.5 mg ranibizumab: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit."
149852|NCT01748292|O1|Outcome|Monthly IVT Ranibizumab|"Monthly intravitreal injections (IVT) ranibizumab for 24 months, not less than 21 days apart to not more than 35 days apart~0.5 mg ranibizumab: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit."
149853|NCT01748292|O2|Outcome|Treat and Extend IVT Ranibizumab|"0.5 mg intravitreal injections (IVT) ranibizumab for 3 consecutive months followed by a treat and extend protocol in which follow-up intervals are increased when there is no clinical and SD-OCT evidence of disease activity by 2-week intervals and patients are treated at every visit. (Comparator arm)~0.5 mg ranibizumab: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit."
149854|NCT01748292|O1|Outcome|Monthly IVT Ranibizumab|"Monthly intravitreal injections (IVT) ranibizumab for 24 months, not less than 21 days apart to not more than 35 days apart~0.5 mg ranibizumab: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit."
149855|NCT01748292|O2|Outcome|Treat and Extend IVT Ranibizumab|"0.5 mg intravitreal injections (IVT) ranibizumab for 3 consecutive months followed by a treat and extend protocol in which follow-up intervals are increased when there is no clinical and SD-OCT evidence of disease activity by 2-week intervals and patients are treated at every visit. (Comparator arm)~0.5 mg ranibizumab: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit."
149856|NCT01748292|O1|Outcome|Monthly IVT Ranibizumab|"Monthly intravitreal injections (IVT) ranibizumab for 24 months, not less than 21 days apart to not more than 35 days apart~0.5 mg ranibizumab: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit."
149857|NCT01748292|O2|Outcome|Treat and Extend IVT Ranibizumab|"0.5 mg intravitreal injections (IVT) ranibizumab for 3 consecutive months followed by a treat and extend protocol in which follow-up intervals are increased when there is no clinical and SD-OCT evidence of disease activity by 2-week intervals and patients are treated at every visit. (Comparator arm)~0.5 mg ranibizumab: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit."
149858|NCT01748292|O1|Outcome|Monthly IVT Ranibizumab|"Monthly intravitreal injections (IVT) ranibizumab for 24 months, not less than 21 days apart to not more than 35 days apart~0.5 mg ranibizumab: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit."
149859|NCT01748292|O2|Outcome|Treat and Extend IVT Ranibizumab|"0.5 mg intravitreal injections (IVT) ranibizumab for 3 consecutive months followed by a treat and extend protocol in which follow-up intervals are increased when there is no clinical and SD-OCT evidence of disease activity by 2-week intervals and patients are treated at every visit. (Comparator arm)~0.5 mg ranibizumab: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit."
149860|NCT01748292|O1|Outcome|Monthly IVT Ranibizumab|"Monthly intravitreal injections (IVT) ranibizumab for 24 months, not less than 21 days apart to not more than 35 days apart~0.5 mg ranibizumab: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit."
149861|NCT01748292|O2|Outcome|Treat and Extend IVT Ranibizumab|"0.5 mg intravitreal injections (IVT) ranibizumab for 3 consecutive months followed by a treat and extend protocol in which follow-up intervals are increased when there is no clinical and SD-OCT evidence of disease activity by 2-week intervals and patients are treated at every visit. (Comparator arm)~0.5 mg ranibizumab: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit."
149862|NCT01748292|O1|Outcome|Monthly IVT Ranibizumab|"Monthly intravitreal injections (IVT) ranibizumab for 24 months, not less than 21 days apart to not more than 35 days apart~0.5 mg ranibizumab: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit."
149863|NCT01748292|E2|Reported Event|Treat and Extend IVT Ranibizumab|"0.5 mg intravitreal injections (IVT) ranibizumab for 3 consecutive months followed by a treat and extend protocol in which follow-up intervals are increased when there is no clinical and SD-OCT evidence of disease activity by 2-week intervals and patients are treated at every visit. (Comparator arm)~0.5 mg ranibizumab: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit."
149864|NCT01748292|E1|Reported Event|Monthly IVT Ranibizumab|"Monthly intravitreal injections (IVT) ranibizumab for 24 months, not less than 21 days apart to not more than 35 days apart~0.5 mg ranibizumab: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit."
149865|NCT01748227|B1|Baseline|Pain Self-Management|"Training of (veteran) peers to deliver pain self-management materials to veterans with chronic pain~Pain Self-Management: Training of veteran peers to deliver pain self-management material to veterans with chronic pain. Veteran peers will then be assigned 2 patients with chronic pain to work with over the next 4 months on pain self-management."
149866|NCT01748227|P1|Participant Flow|Pain Self-Management|"Training of (veteran) peers to deliver pain self-management materials to veterans with chronic pain~Pain Self-Management: Training of veteran peers to deliver pain self-management material to veterans with chronic pain. Veteran peers will then be assigned 2 patients with chronic pain to work with over the next 4 months on pain self-management."
149867|NCT01748227|O1|Outcome|Pain Self-Management|"Peer delivery of pain self-management to veterans~Trained peers were each assigned 2 veterans to meet with regularly for 4 months and discuss pain self-management and coping strategies."
149868|NCT01748227|O1|Outcome|Pain Self-Management|"Peer delivery of pain self-management to veterans~Trained peers were each assigned 2 veterans to meet with regularly for 4 months and discuss pain self-management and coping strategies."
149869|NCT01748227|O1|Outcome|Pain Self-Management|"Peer delivery of pain self-management to veterans~Trained peers were each assigned 2 veterans to meet with regularly for 4 months and discuss pain self-management and coping strategies."
149870|NCT01748227|O1|Outcome|Pain Self-Management|"Training of (veteran) peers to deliver pain self-management materials to veterans with chronic pain~Pain Self-Management: Training of veteran peers to deliver pain self-management material to veterans with chronic pain. Veteran peers will then be assigned 2 patients with chronic pain to work with over the next 4 months on pain self-management."
149871|NCT01748227|O1|Outcome|Pain Self-Management|"Peer delivery of pain self-management to veterans~Trained peers were each assigned 2 veterans to meet with regularly for 4 months and discuss pain self-management and coping strategies."
149872|NCT01748227|E1|Reported Event|Pain Self-Management|"Training of (veteran) peers to deliver pain self-management materials to veterans with chronic pain~Pain Self-Management: Training of veteran peers to deliver pain self-management material to veterans with chronic pain. Veteran peers will then be assigned 2 patients with chronic pain to work with over the next 4 months on pain self-management."
149873|NCT01748162|B3|Baseline|Total|Total of all reporting groups
149874|NCT01748162|B2|Baseline|Oral Control|Short term oral prednisolone. Offered at 1mg/kg daily dosing for symptomatic treatment on as needed basis for three days, but may be modified per managing physician's discretion.
149875|NCT01748162|B1|Baseline|Inhaled Steroids|"Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.~Fluticasone: Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months."
149876|NCT01748162|P2|Participant Flow|Oral Control|Short term oral prednisolone. Offered at 1mg/kg daily dosing for symptomatic treatment on as needed basis for three days, but may be modified per managing physician's discretion.
149877|NCT01748162|P1|Participant Flow|Inhaled Steroids|"Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.~Fluticasone: Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months."
149879|NCT01748162|O1|Outcome|Inhaled Steroids|"Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.~Fluticasone: Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months."
149880|NCT01748162|O2|Outcome|Oral Control|Short term oral prednisolone. Offered at 1mg/kg daily dosing for symptomatic treatment on as needed basis for three days, but may be modified per managing physician's discretion.
149881|NCT01748162|O1|Outcome|Inhaled Steroids|"Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.~Fluticasone: Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months."
149882|NCT01748162|E2|Reported Event|Oral Control|Short term oral prednisolone. Offered at 1mg/kg daily dosing for symptomatic treatment on as needed basis for three days, but may be modified per managing physician's discretion.
149883|NCT01748162|E1|Reported Event|Inhaled Steroids|"Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.~Fluticasone: Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months."
149884|NCT01748071|B4|Baseline|Total|Total of all reporting groups
149885|NCT01748071|B3|Baseline|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
149886|NCT01748071|B2|Baseline|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
149887|NCT01748071|B1|Baseline|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
149888|NCT01748071|P3|Participant Flow|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
149889|NCT01748071|P2|Participant Flow|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
149890|NCT01748071|P1|Participant Flow|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
149891|NCT01748071|O3|Outcome|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
149892|NCT01748071|O2|Outcome|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
149893|NCT01748071|O1|Outcome|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
149894|NCT01748071|O3|Outcome|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
149895|NCT01748071|O2|Outcome|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
149896|NCT01748071|O1|Outcome|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
149897|NCT01748071|O3|Outcome|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
149898|NCT01748071|O2|Outcome|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
149899|NCT01748071|O1|Outcome|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
149900|NCT01748071|O3|Outcome|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
149901|NCT01748071|O2|Outcome|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
149902|NCT01748071|O1|Outcome|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
149903|NCT01748071|O3|Outcome|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
149904|NCT01748071|O2|Outcome|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
149905|NCT01748071|O1|Outcome|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
149906|NCT01748071|E3|Reported Event|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
149907|NCT01748071|E2|Reported Event|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
149908|NCT01748071|E1|Reported Event|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
149909|NCT01748045|B3|Baseline|Total|Total of all reporting groups
149910|NCT01748045|B2|Baseline|Nitrogen Gas|"Placebo gas will be adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose will then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~Placebo Comparator - nitrogen gas"
149911|NCT01748045|B1|Baseline|Inhaled Nitric Oxide|"iNO to start at 20ppm for the first three days of life. The dose will then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~inhaled nitric oxide"
149912|NCT01748045|P2|Participant Flow|Nitrogen Gas|"Number of participants who have started on placebo gas that was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~Placebo Comparator - nitrogen gas"
149913|NCT01748045|P1|Participant Flow|Inhaled Nitric Oxide (iNO)|"Number of participants who have started on iNO at 20 parts per million (ppm) for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~inhaled nitric oxide"
149914|NCT01748045|O2|Outcome|Nitrogen Gas|"Number of participants who have started on placebo gas that was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~Placebo Comparator - nitrogen gas"
149915|NCT01748045|O1|Outcome|Inhaled Nitric Oxide|"Number of participants who have started on iNO at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~inhaled nitric oxide"
149916|NCT01748045|O2|Outcome|Nitrogen Gas|"Number of participants who have started on placebo gas was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~Placebo Comparator - nitrogen gas"
151057|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
149917|NCT01748045|O1|Outcome|Inhaled Nitric Oxide|"Number of participants who have started on iNO at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~inhaled nitric oxide"
149918|NCT01748045|O2|Outcome|Nitrogen Gas|"Number of participants who have started on placebo gas was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~Placebo Comparator - nitrogen gas"
149919|NCT01748045|O1|Outcome|Inhaled Nitric Oxide|"Number of participants who have started on iNO at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~inhaled nitric oxide"
149920|NCT01748045|O2|Outcome|Nitrogen Gas|"Number of participants who have started on placebo gas will be adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose were then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~Placebo Comparator - nitrogen gas"
149921|NCT01748045|O1|Outcome|Inhaled Nitric Oxide|"Number of participants who have started on iNO at 20ppm for the first three days of life. The dose were then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~inhaled nitric oxide"
149922|NCT01748045|O2|Outcome|Nitrogen Gas|"Number of participants who have started on placebo gas which was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~Placebo Comparator - nitrogen gas"
149923|NCT01748045|O1|Outcome|Inhaled Nitric Oxide|"Number of participants who have started on iNO at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~inhaled nitric oxide"
149924|NCT01748045|O2|Outcome|Nitrogen Gas|"Number of participants who have started on placebo gas that was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~Placebo Comparator - nitrogen gas"
149925|NCT01748045|O1|Outcome|Inhaled Nitric Oxide|"Number of participants who have started on iNO at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~inhaled nitric oxide"
149926|NCT01748045|O2|Outcome|Nitrogen Gas|"Number of participants who were started on placebo gas that was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~Placebo Comparator - nitrogen gas"
149927|NCT01748045|O1|Outcome|Inhaled Nitric Oxide|"Number of participants who were started on inhaled Nitric Oxide (iNO) at 20 parts per million (ppm) for the first three days of life. The dose was then decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~inhaled nitric oxide"
149928|NCT01748045|E2|Reported Event|Nitrogen Gas|"Number of participants who have started on placebo gas that was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~Placebo Comparator - nitrogen gas"
149929|NCT01748045|E1|Reported Event|Inhaled Nitric Oxide|"Number of participants who have started on iNO at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.~inhaled nitric oxide"
149930|NCT01747928|B9|Baseline|Total|Total of all reporting groups
149931|NCT01747928|B8|Baseline|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149932|NCT01747928|B7|Baseline|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149933|NCT01747928|B6|Baseline|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149934|NCT01747928|B5|Baseline|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149935|NCT01747928|B4|Baseline|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149936|NCT01747928|B3|Baseline|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149937|NCT01747928|B2|Baseline|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149938|NCT01747928|B1|Baseline|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149939|NCT01747928|P8|Participant Flow|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149940|NCT01747928|P7|Participant Flow|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149941|NCT01747928|P6|Participant Flow|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149942|NCT01747928|P5|Participant Flow|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149943|NCT01747928|P4|Participant Flow|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149944|NCT01747928|P3|Participant Flow|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149945|NCT01747928|P2|Participant Flow|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149946|NCT01747928|P1|Participant Flow|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149947|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149948|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149949|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149950|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149951|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149952|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149953|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149954|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149955|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149956|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149957|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149958|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149959|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149960|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149961|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149962|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149963|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149964|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149965|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149966|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149967|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149968|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149969|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149970|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149971|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149972|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149973|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149974|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149975|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149976|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149977|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149978|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149979|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149980|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149981|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149982|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149983|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149984|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149985|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149986|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149987|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149988|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149989|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149990|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149991|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149992|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
164951|NCT01694108|O2|Outcome|Control Children|No intervention
149993|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149994|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149995|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149996|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149997|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149998|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
149999|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150000|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150001|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150002|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150003|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150004|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150005|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150006|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150007|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150008|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150009|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150010|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150011|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150012|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150013|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150014|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150015|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150016|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150017|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150018|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150019|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150020|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150021|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150022|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150023|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150024|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150025|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150026|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150027|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150028|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150029|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150030|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150031|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150032|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150033|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150034|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150035|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150036|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150037|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150038|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150039|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150040|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150041|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150042|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150043|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150044|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
164952|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
150045|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150046|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150047|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150048|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150049|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150050|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150051|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150052|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150053|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150054|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150055|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150056|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150057|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150058|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150059|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150060|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150061|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150062|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150063|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150064|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150065|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150066|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150067|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150068|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150069|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150070|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
164953|NCT01694108|O2|Outcome|Control Children|No intervention
150071|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150072|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150073|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150074|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150075|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150076|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150077|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150078|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150079|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150080|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150081|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150082|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150083|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150084|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150085|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150086|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150087|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150088|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150089|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150090|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150091|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150092|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150093|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150094|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150095|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150096|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
164954|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
150097|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150098|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150099|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150100|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150101|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150102|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150103|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150104|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150105|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150106|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150107|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150108|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150109|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150110|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150111|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150112|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150113|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150114|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150115|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150116|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150117|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150118|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150119|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150120|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150121|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150122|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150123|NCT01747928|O9|Outcome|All Participants|All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
150124|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150125|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150126|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150127|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150128|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150129|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150130|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150131|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150132|NCT01747928|O9|Outcome|All Participants|All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
150133|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150134|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150135|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150136|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150137|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150138|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150139|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150140|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150141|NCT01747928|E8|Reported Event|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150142|NCT01747928|E7|Reported Event|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150143|NCT01747928|E6|Reported Event|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150144|NCT01747928|E5|Reported Event|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150145|NCT01747928|E4|Reported Event|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150146|NCT01747928|E3|Reported Event|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150147|NCT01747928|E2|Reported Event|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
151532|NCT01740440|E1|Reported Event|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks~BMR Face"
150148|NCT01747928|E1|Reported Event|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
150149|NCT01747850|B4|Baseline|Total|Total of all reporting groups
150150|NCT01747850|B3|Baseline|Pilot Study|"The first five subjects will be treatment-seekers that fit our inclusion/exclusion criteria and that will be treated open-label. These first subjects will allow us to determine if our schedule for dosing is appropriate for the subsequent phase of the study.~All participants will receive a combination of pharmacotherapy (Sativex) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy.~Sativex: Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The medication treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Spray that will be decreased by 50% to avoid abrupt withdrawal)."
150151|NCT01747850|B2|Baseline|Placebo Spray|"Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy~Placebo spray: Study subjects will gradually increase the maximal allowed dose of Placebo starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The Placebo treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Placebo Spray that will be decreased by 50%)."
150152|NCT01747850|B1|Baseline|Sativex|"Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). There will be a gradual increase of the maximal allowed dose starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays per day at the end of week 2. There will be a total of 12 weeks of drug exposure associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy.~Sativex: Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The medication treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Spray that will be decreased by 50% to avoid abrupt withdrawal)."
150153|NCT01747850|P3|Participant Flow|Placebo Spray|"Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy~Placebo spray: Study subjects will gradually increase the maximal allowed dose of Placebo starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The Placebo treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Placebo Spray that will be decreased by 50%). Then exposure to Placebo will be stopped (so there will be a total of 12 weeks Placebo treatment exposure)."
150154|NCT01747850|P2|Participant Flow|Sativex|Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). Study subjects will be randomized in blocks of ten to one of the two groups (Sativex vs. placebo) in a double blind manner. There will be a gradual increase of the maximal allowed dose starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays per day at the end of week 2. There will be a total of 12 weeks of drug exposure (the last week will be a reduction phase with the use of Spray that will be decreased by 50% to avoid abrupt withdrawal). All participants will receive a combination of pharmacotherapy (Sativex or Placebo) associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy.
150155|NCT01747850|P1|Participant Flow|Pilot Study|"The first five subjects will be treatment-seekers that will be treated open-label. These first subjects will allow us to determine if our schedule for dosing is appropriate for the subsequent phase of the study.~Motivational Enhancement/Cognitive Behavioral Therapy: All participants will receive a combination of pharmacotherapy (Sativex) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy.~Sativex: Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The medication treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Spray that will be decreased by 50% to avoid abrupt withdrawal)."
150156|NCT01747850|O3|Outcome|Pilot Cannabis Use (g)|The first five subjects will be treatment-seekers that fit our inclusion/exclusion criteria and that will be treated open-label.
150157|NCT01747850|O2|Outcome|Placebo Cannabis Use (g)|Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy
150158|NCT01747850|O1|Outcome|Sativex Cannabis Use (g)|Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). There will be a total of 12 weeks of drug exposure. All participants will receive a combination of pharmacotherapy (Sativex associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy.
150159|NCT01747850|O3|Outcome|Pilot Craving|The first five subjects will be treatment-seekers that fit our inclusion/exclusion criteria and that will be treated open-label.
150160|NCT01747850|O2|Outcome|Placebo Craving|Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy
150161|NCT01747850|O1|Outcome|Sativex Craving|Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). There will be a total of 12 weeks of drug exposure. All participants will receive a combination of pharmacotherapy (Sativex associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy.
150162|NCT01747850|O3|Outcome|Pilot Withdrawal|The first five subjects will be treatment-seekers that fit our inclusion/exclusion criteria and that will be treated open-label.
150163|NCT01747850|O2|Outcome|Placebo Withdrawal|Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy
151058|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
150164|NCT01747850|O1|Outcome|Sativex Withdrawal|Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). There will be a total of 12 weeks of drug exposure. All participants will receive a combination of pharmacotherapy (Sativex associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy.
150165|NCT01747850|O3|Outcome|Pilot % Days Use of Cannabis|The first five subjects will be treatment-seekers that fit our inclusion/exclusion criteria and that will be treated open-label.
150166|NCT01747850|O2|Outcome|Placebo % Days Use of Cannabis|Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy
150167|NCT01747850|O1|Outcome|Sativex % Days Use of Cannabis|Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). There will be a total of 12 weeks of drug exposure. All participants will receive a combination of pharmacotherapy (Sativex associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy.
150168|NCT01747850|O3|Outcome|Pilot Study # of Participants That Withdrew Due SAE|"The first five subjects will be treatment-seekers that fit our inclusion/exclusion criteria and that will be treated open-label. These subjects will be instructed to use the Sativex Spray according to the induction schedule provided above. These first subjects will allow us to determine if our schedule for dosing is appropriate for the subsequent phase of the study.~Motivational Enhancement/Cognitive Behavioral Therapy: All participants will receive a combination of pharmacotherapy (Sativex or Placebo) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy.~Sativex: Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The target quit date will be set at Day 21 (but subjects will be allowed to stop using cannabis before if"
150169|NCT01747850|O2|Outcome|Placebo # of Participants That Withdrew Due SAE|Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy
150170|NCT01747850|O1|Outcome|Sativex # of Participants That Withdrew Due SAE|Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). There will be a total of 12 weeks of drug exposure. All participants will receive a combination of pharmacotherapy (Sativex associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy.
150171|NCT01747850|E3|Reported Event|Pilot Study|"The first five subjects will be treatment-seekers that will be treated open-label.~Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). There will be a total of 12 weeks medication treatment exposure).~Motivational Enhancement/Cognitive Behavioral Therapy: All participants will receive a combination of pharmacotherapy (Sativex) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy."
150172|NCT01747850|E2|Reported Event|Placebo Spray|"Placebo spray: Study subjects will gradually increase the maximal allowed dose of Placebo starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). There will be a total of 12 weeks Placebo treatment exposure.~Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy"
150173|NCT01747850|E1|Reported Event|Sativex|"Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). There will be a gradual increase of the maximal allowed dose starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays per day at the end of week 2. There will be a total of 12 weeks of drug exposure.~All participants will receive a combination of pharmacotherapy (Sativex ) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy."
150174|NCT01747811|B3|Baseline|Total|Total of all reporting groups
150175|NCT01747811|B2|Baseline|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
150176|NCT01747811|B1|Baseline|Wavelength-1 Bright Light|"30 minutes daily light exposure for 6 weeks~wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
150177|NCT01747811|P2|Participant Flow|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
150178|NCT01747811|P1|Participant Flow|Wavelength-1 Bright Light|30 minutes daily light exposure for 6 weeks
150179|NCT01747811|O2|Outcome|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
150180|NCT01747811|O1|Outcome|Wavelength-1 Bright Light|30 minutes daily light exposure for 6 weeks
150181|NCT01747811|O2|Outcome|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
150182|NCT01747811|O1|Outcome|Wavelength-1 Bright Light|"30 minutes daily light exposure for 6 weeks~wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
150183|NCT01747811|O2|Outcome|Wavelength-2 Bright Light|"30 minutes daily light exposure for 6 weeks~wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
150184|NCT01747811|O1|Outcome|Wavelength-1 Bright Light|"30 minutes daily light exposure for 6 weeks~wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
150185|NCT01747811|O2|Outcome|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
150186|NCT01747811|O1|Outcome|Wavelength-1 Bright Light|30 minutes daily light exposure for 6 weeks
150187|NCT01747811|O2|Outcome|Wavelength-2 Bright Light|"30 minutes daily light exposure for 6 weeks~wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
150188|NCT01747811|O1|Outcome|Wavelength-1 Bright Light|"30 minutes daily light exposure for 6 weeks~wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
150189|NCT01747811|O2|Outcome|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
150190|NCT01747811|O1|Outcome|Wavelength-1 Bright Light|"30 minutes daily light exposure for 6 weeks~wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
150191|NCT01747811|E2|Reported Event|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
150192|NCT01747811|E1|Reported Event|Wavelength-1 Bright Light|30 minutes daily light exposure for 6 weeks
150193|NCT01747772|B1|Baseline|Shear Wave Sonoelastography for Fibrosis Assessment|Shear Wave sonoelastography (SWE) was performed in patients who were scheduled for a non-focal liver biopsy.
150194|NCT01747772|P1|Participant Flow|Shear Wave Sonoelastography for Fibrosis Assessment|Shear Wave sonoelastography (SWE) was performed in patients who were scheduled for a non-focal liver biopsy.
150195|NCT01747772|O5|Outcome|Fibrosis 4|Participants with cirrhosis on liver biopsy evaluation.
150196|NCT01747772|O4|Outcome|Fibrosis 3|Participants with numerous septa without cirrhosis on liver biopsy evaluation.
150197|NCT01747772|O3|Outcome|Fibrosis 2|Participants with portal fibrosis with few septa on liver biopsy evaluation.
150198|NCT01747772|O2|Outcome|Fibrosis 1|Participants with portal fibrosis without septa on liver biopsy evaluation.
150199|NCT01747772|O1|Outcome|Fibrosis 0|Participants with no fibrosis on liver biopsy evaluation.
150200|NCT01747772|E1|Reported Event|Shear Wave Sonoelastography for Fibrosis Assessment|Shear Wave sonoelastography (SWE) was performed in patients who were scheduled for a non-focal liver biopsy.
150201|NCT01747655|B1|Baseline|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
150202|NCT01747655|P2|Participant Flow|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
150203|NCT01747655|P1|Participant Flow|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
150204|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
150205|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
150206|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
150207|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
150208|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
150209|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
150210|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
150211|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
150212|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
150213|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
150214|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
150215|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
150216|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
150217|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
150218|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
150219|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
150220|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
150221|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
150222|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
150223|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
150224|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
150225|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications.
150226|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
150227|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
150228|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
150229|NCT01747655|E1|Reported Event|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy
150230|NCT01747629|B3|Baseline|Total|Total of all reporting groups
151533|NCT01740427|B3|Baseline|Total|Total of all reporting groups
150231|NCT01747629|B2|Baseline|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
150232|NCT01747629|B1|Baseline|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
150233|NCT01747629|P2|Participant Flow|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
150234|NCT01747629|P1|Participant Flow|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
150235|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
150236|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
150237|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
150238|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
150239|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
150240|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
150241|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
150242|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
150243|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
150244|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
150245|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
150246|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
150247|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
150248|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
150249|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
150250|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
150251|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
150252|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
150253|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
150254|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
150255|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
150256|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
150257|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
150258|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
150259|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
150260|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
150261|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
150262|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
150263|NCT01747629|E2|Reported Event|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
150264|NCT01747629|E1|Reported Event|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
150265|NCT01747551|B3|Baseline|Total|Total of all reporting groups
150266|NCT01747551|B2|Baseline|mFOLFOX6 + Placebo|Patients received mFOLFOX6 and placebo every 2 weeks. Placebo was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death.
150282|NCT01747343|O1|Outcome|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
150267|NCT01747551|B1|Baseline|mFOLFOX6 + Ziv-aflibercept|Patients received mFOLFOX6 and ziv-aflibercept every 2 weeks. Ziv-aflibercept 4mg/kg was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death.
150268|NCT01747551|P2|Participant Flow|mFOLFOX6 + Placebo|Patients received mFOLFOX6 and placebo every 2 weeks. Placebo was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death.
150269|NCT01747551|P1|Participant Flow|mFOLFOX6 + Ziv-aflibercept|Patients received mFOLFOX6 and ziv-aflibercept every 2 weeks. Ziv-aflibercept 4mg/kg was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death.
150270|NCT01747551|O2|Outcome|mFOLFOX6 + Placebo|Patients received mFOLFOX6 and placebo every 2 weeks. Placebo was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death.
150271|NCT01747551|O1|Outcome|mFOLFOX6 + Ziv-aflibercept|Patients received mFOLFOX6 and ziv-aflibercept every 2 weeks. Ziv-aflibercept 4mg/kg was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death.
150272|NCT01747551|O2|Outcome|mFOLFOX6 + Placebo|Patients received mFOLFOX6 and placebo every 2 weeks. Placebo was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death.
150273|NCT01747551|O1|Outcome|mFOLFOX6 + Ziv-aflibercept|Patients received mFOLFOX6 and ziv-aflibercept every 2 weeks. Ziv-aflibercept 4mg/kg was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death.
150274|NCT01747551|O2|Outcome|mFOLFOX6 + Placebo|Patients received mFOLFOX6 and placebo every 2 weeks. Placebo was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death.
150275|NCT01747551|O1|Outcome|mFOLFOX6 + Ziv-aflibercept|Patients received mFOLFOX6 and ziv-aflibercept every 2 weeks. Ziv-aflibercept 4mg/kg was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death.
150276|NCT01747551|O2|Outcome|mFOLFOX6 + Placebo|Patients received mFOLFOX6 and placebo every 2 weeks. Placebo was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death.
150277|NCT01747551|O1|Outcome|mFOLFOX6 + Ziv-aflibercept|Patients received mFOLFOX6 and ziv-aflibercept every 2 weeks. Ziv-aflibercept 4mg/kg was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death.
150278|NCT01747551|E2|Reported Event|mFOLFOX6 + Placebo|Patients received mFOLFOX6 and placebo every 2 weeks. Placebo was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death.
150279|NCT01747551|E1|Reported Event|mFOLFOX6 + Ziv-aflibercept|Patients received mFOLFOX6 and ziv-aflibercept every 2 weeks. Ziv-aflibercept 4mg/kg was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death.
150280|NCT01747343|B1|Baseline|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
150281|NCT01747343|P1|Participant Flow|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
150283|NCT01747343|O1|Outcome|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
150284|NCT01747343|O1|Outcome|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
150285|NCT01747343|E1|Reported Event|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
150286|NCT01747330|B1|Baseline|Creon Micro, Minimicrospheres|Pancreatin: Doses of pancreatin <2500 lipase u/kg/feed or <4000 lipase u/g fat/intake or <10000 lipase u/kg/day given orally are used
150287|NCT01747330|P1|Participant Flow|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
150288|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
150289|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
150290|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
150291|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
150292|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
150293|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
150294|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
150295|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
150296|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
150297|NCT01747330|E1|Reported Event|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
150298|NCT01746979|B3|Baseline|Total|Total of all reporting groups
150299|NCT01746979|B2|Baseline|Gemcitabine Plus Placebo|"Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Placebo (5 percent dextrose - D5W): TH-302 placebo (5 percent dextrose - D5W) will be administered as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal."
150300|NCT01746979|B1|Baseline|Gemcitabine Plus TH-302|"TH-302: TH-302 will be administered at a dose of 340 milligrams per square meter (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal."
150301|NCT01746979|P2|Participant Flow|Gemcitabine Plus Placebo|"Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Placebo (5 percent dextrose - D5W): TH-302 placebo (5 percent dextrose - D5W) will be administered as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal."
150302|NCT01746979|P1|Participant Flow|Gemcitabine Plus TH-302|"TH-302: TH-302 will be administered at a dose of 340 milligrams per square meter (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal."
150303|NCT01746979|O2|Outcome|Gemcitabine Plus Placebo|"Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Placebo (5 percent dextrose - D5W): TH-302 placebo (5 percent dextrose - D5W) will be administered as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal."
150304|NCT01746979|O1|Outcome|Gemcitabine Plus TH-302|"TH-302: TH-302 will be administered at a dose of 340 milligrams per square meter (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal."
150305|NCT01746979|O2|Outcome|Gemcitabine Plus Placebo|"Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Placebo (5 percent dextrose - D5W): TH-302 placebo (5 percent dextrose - D5W) will be administered as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal."
150376|NCT01746784|E2|Reported Event|5 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
150306|NCT01746979|O1|Outcome|Gemcitabine Plus TH-302|"TH-302: TH-302 will be administered at a dose of 340 milligrams per square meter (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal."
150307|NCT01746979|E2|Reported Event|Placebo|"Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Placebo (5 percent dextrose - D5W): TH-302 placebo (5 percent dextrose - D5W) will be administered as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal."
150308|NCT01746979|E1|Reported Event|TH-302|"TH-302: TH-302 will be administered at a dose of 340 milligrams per square meter (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.~Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal."
150309|NCT01746940|B5|Baseline|Total|Total of all reporting groups
150310|NCT01746940|B4|Baseline|Not Randomized|Enrolled subjects who are not randomized to treatment due to early withdrawal from the study
150311|NCT01746940|B3|Baseline|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
150312|NCT01746940|B2|Baseline|Cocaine HCl 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
150313|NCT01746940|B1|Baseline|Cocaine HCl 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
150314|NCT01746940|P4|Participant Flow|Not Randomized|Enrolled subjects who are not randomized to treatment due to early withdrawal from the study
150315|NCT01746940|P3|Participant Flow|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
150316|NCT01746940|P2|Participant Flow|Cocaine HCl 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
150317|NCT01746940|P1|Participant Flow|Cocaine HCl 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
150318|NCT01746940|O3|Outcome|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
150319|NCT01746940|O2|Outcome|Cocaine HCl 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
150320|NCT01746940|O1|Outcome|Cocaine HCl 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
150321|NCT01746940|E3|Reported Event|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
150322|NCT01746940|E2|Reported Event|Cocaine HCl 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
150323|NCT01746940|E1|Reported Event|Cocaine HCl 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
150324|NCT01746862|B3|Baseline|Total|Total of all reporting groups
150325|NCT01746862|B2|Baseline|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
150326|NCT01746862|B1|Baseline|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
150327|NCT01746862|P2|Participant Flow|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
150328|NCT01746862|P1|Participant Flow|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
150329|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
150330|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
150331|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
150332|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
150333|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
150334|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
150335|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
150336|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
150377|NCT01746784|E1|Reported Event|Placebo/Saline|0.9% (weight/volume) NaCl was administered intravenously using the same volume as the active drug group.
150337|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
150338|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
150339|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
150340|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
150341|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
150342|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
150343|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
150344|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
150345|NCT01746862|E2|Reported Event|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
150346|NCT01746862|E1|Reported Event|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
150347|NCT01746784|B6|Baseline|Total|Total of all reporting groups
150348|NCT01746784|B5|Baseline|40mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
150349|NCT01746784|B4|Baseline|20mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
150350|NCT01746784|B3|Baseline|10mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
150351|NCT01746784|B2|Baseline|5mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
150352|NCT01746784|B1|Baseline|Normal Saline|Normal saline: IV solution of 0.9% (weight/volume) NaCl administered by infusion pump over 1-8 minutes
150353|NCT01746784|P5|Participant Flow|40 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
150354|NCT01746784|P4|Participant Flow|20mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
150355|NCT01746784|P3|Participant Flow|10 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
150356|NCT01746784|P2|Participant Flow|5 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
150357|NCT01746784|P1|Participant Flow|Placebo/Saline|0.9% (weight/volume) NaCl was administered intravenously using the same volume as the active drug group.
150358|NCT01746784|O5|Outcome|40mg/N6022|"N6022 by IV infusion once per day for 7 days~N6022 in normal saline administered by infusion pump over 1-8 minutes"
150359|NCT01746784|O4|Outcome|20mg/N6022|"N6022 by IV infusion once per day for 7 days~N6022: Intravenous solution of N6022 in normal saline"
150360|NCT01746784|O3|Outcome|10mg/N6022|"N6022 by IV infusion once per day for 7 days~N6022: Intravenous solution of N6022 in normal saline"
150361|NCT01746784|O2|Outcome|5mg/N6022|"N6022 by IV infusion once per day for 7 days~N6022: Intravenous solution of N6022 in normal saline"
150362|NCT01746784|O1|Outcome|Normal Saline|Placebo will receive IV normal saline Normal saline: Intravenous solution of 0.9% (weight/volume) NaCl
150363|NCT01746784|O5|Outcome|40mg/N6022|Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
150364|NCT01746784|O4|Outcome|20mg/N6022|Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
150365|NCT01746784|O3|Outcome|10mg/N6022|Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
150366|NCT01746784|O2|Outcome|5mg/N6022|Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
150367|NCT01746784|O1|Outcome|Normal Saline|Normal saline: Intravenous solution of 0.9% (weight/volume) NaCl administered by infusion pump over 1-8 minutes
150368|NCT01746784|O5|Outcome|40mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
150369|NCT01746784|O4|Outcome|20mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
150370|NCT01746784|O3|Outcome|10mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
150371|NCT01746784|O2|Outcome|5mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
150372|NCT01746784|O1|Outcome|Normal Saline|Normal saline: Intravenous solution of 0.9% (weight/volume) NaCl administered by infusion pump over 1-8 minutes
150373|NCT01746784|E5|Reported Event|40 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
150374|NCT01746784|E4|Reported Event|20mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
150375|NCT01746784|E3|Reported Event|10 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
150379|NCT01746511|B2|Baseline|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
150380|NCT01746511|B1|Baseline|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams. All infants in this study arm will receive our"
150381|NCT01746511|P2|Participant Flow|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
150382|NCT01746511|P1|Participant Flow|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams."
150383|NCT01746511|O2|Outcome|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
150384|NCT01746511|O1|Outcome|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams."
150385|NCT01746511|O2|Outcome|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
150386|NCT01746511|O1|Outcome|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams."
150397|NCT01746368|B1|Baseline|Nurse-Supported Advance Care Planning Intervention|The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.
150519|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
150387|NCT01746511|O2|Outcome|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
150388|NCT01746511|O1|Outcome|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams."
150389|NCT01746511|O2|Outcome|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
150390|NCT01746511|O1|Outcome|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams."
150391|NCT01746511|O2|Outcome|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
150392|NCT01746511|O1|Outcome|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams."
150393|NCT01746511|E2|Reported Event|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
150394|NCT01746511|E1|Reported Event|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams. All infants in this study arm will receive our"
150395|NCT01746368|B3|Baseline|Total|Total of all reporting groups
150396|NCT01746368|B2|Baseline|Care-as-Usual|The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
150398|NCT01746368|P2|Participant Flow|Care-as-Usual|The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
150399|NCT01746368|P1|Participant Flow|Nurse-Supported Advance Care Planning Intervention|The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.
150400|NCT01746368|O2|Outcome|Care-as-Usual|The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
150401|NCT01746368|O1|Outcome|Nurse-Supported Advance Care Planning Intervention|The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.
150402|NCT01746368|O2|Outcome|Care-as-Usual|The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
150403|NCT01746368|O1|Outcome|Nurse-Supported Advance Care Planning Intervention|The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.
150404|NCT01746368|E2|Reported Event|Care-as-Usual|The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
150405|NCT01746368|E1|Reported Event|Nurse-Supported Advance Care Planning Intervention|The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.
150406|NCT01746264|B1|Baseline|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
150407|NCT01746264|P1|Participant Flow|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
150408|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
150409|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
150410|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
150411|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
150412|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
150413|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
150414|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
150415|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
150416|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
150417|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
150418|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
150419|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
150420|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
150421|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
150422|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
150423|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
150424|NCT01746264|E1|Reported Event|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
150425|NCT01746173|B1|Baseline|CHOEP + High Dose Therapy + Auto SCT|Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
150520|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
150426|NCT01746173|P1|Participant Flow|CHOEP + High Dose Therapy + Auto SCT|Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
150427|NCT01746173|O1|Outcome|CHOEP + High Dose Therapy + Auto SCT|Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
150428|NCT01746173|O1|Outcome|CHOEP + High Dose Therapy + Auto SCT|Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
150429|NCT01746173|E1|Reported Event|CHOEP + High Dose Therapy + Auto SCT|Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
150430|NCT01746108|B4|Baseline|Total|Total of all reporting groups
150431|NCT01746108|B3|Baseline|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
150432|NCT01746108|B2|Baseline|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
150433|NCT01746108|B1|Baseline|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
150434|NCT01746108|P3|Participant Flow|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
150435|NCT01746108|P2|Participant Flow|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
150436|NCT01746108|P1|Participant Flow|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
150437|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
150438|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
150439|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
150440|NCT01746108|O3|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
150441|NCT01746108|O2|Outcome|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
150442|NCT01746108|O1|Outcome|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
150443|NCT01746108|O3|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
150444|NCT01746108|O2|Outcome|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
150445|NCT01746108|O1|Outcome|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
150446|NCT01746108|O1|Outcome|Synflorix AR- UN-5-17Y Group|Subset of the AR- UN-5-17Y Group including subjects aged between 5 and 17 years.
150447|NCT01746108|O2|Outcome|Synflorix AR- UN-5-17Y Group|Subset of the AR- UN-5-17Y Group including subjects aged between 5 and 17 years.
150448|NCT01746108|O1|Outcome|Synflorix AR-PR-5-17Y Group|Subset of the AR-PR-2-17Y Group including subjects aged between 5 and 17 years.
150449|NCT01746108|O2|Outcome|Synflorix AR-Un-2-4Y Group|Subset of the AR-UN-2-17Y Group including subjects aged between 24 and 59 months.
150450|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
150451|NCT01746108|O3|Outcome|Synflorix AR-Un-2-4Y Group|Subset of the AR-UN-2-17Y Group including subjects aged between 24 and 59 months.
150452|NCT01746108|O2|Outcome|Synflorix AR-PR-2-4Y Group|Subset of the AR-PR-2-17Y Group including subjects aged between 24 and 59 months.
150453|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
150454|NCT01746108|O1|Outcome|Synflorix AR- UN-5-17Y Group|Subset of the AR- UN-5-17Y Group including subjects aged between 5 and 17 years.
150455|NCT01746108|O2|Outcome|Synflorix AR- UN-5-17Y Group|Subset of the AR- UN-5-17Y Group including subjects aged between 5 and 17 years.
150456|NCT01746108|O1|Outcome|Synflorix AR-PR-5-17Y Group|Subset of the AR-PR-2-17Y Group including subjects aged between 5 and 17 years.
150457|NCT01746108|O2|Outcome|Synflorix AR-Un-2-4Y Group|Subset of the AR-UN-2-17Y Group including subjects aged between 24 and 59 months.
150458|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
150459|NCT01746108|O3|Outcome|Synflorix AR-Un-2-4Y Group|Subset of the AR-UN-2-17Y Group including subjects aged between 24 and 59 months.
150460|NCT01746108|O2|Outcome|Synflorix AR-PR-2-4Y Group|Subset of the AR-PR-2-17Y Group including subjects aged between 24 and 59 months.
150461|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
150483|NCT01745952|O1|Outcome|Figure-of-eight Active rTMS Coil|"rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
150484|NCT01745952|O1|Outcome|Any Difference Between the Four Conditions|effect of baseline/ figure-of-eight/ round/ sham treatment period on the seizure frequency of the patients
150552|NCT01745133|B4|Baseline|Total|Total of all reporting groups
157646|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
150462|NCT01746108|O1|Outcome|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
150463|NCT01746108|O1|Outcome|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
150464|NCT01746108|O1|Outcome|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
150465|NCT01746108|O1|Outcome|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
150466|NCT01746108|O1|Outcome|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
150467|NCT01746108|O1|Outcome|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
150468|NCT01746108|E3|Reported Event|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
150469|NCT01746108|E2|Reported Event|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
150516|NCT01745380|P2|Participant Flow|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
157647|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
150470|NCT01746108|E1|Reported Event|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
150471|NCT01745952|B1|Baseline|All Participants|description of the patients at the onset of the study
150472|NCT01745952|P3|Participant Flow|Sham Coil; Then Figure-of-eight Active Coil; Then Round Active|"rTMS using the sham coil over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
150473|NCT01745952|P2|Participant Flow|Round Active Coil; Then Sham; Then Figure-of-eight Active Coil|"rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
150474|NCT01745952|P1|Participant Flow|Figure-of-eight Active Coil; Then Round Active Coil; Then Sham|"rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
150475|NCT01745952|O3|Outcome|Sham rTMS Coil (Figure-of-eight)|"rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
150476|NCT01745952|O2|Outcome|Round Active rTMS Coil|"rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
150477|NCT01745952|O1|Outcome|Figure-of-eight Active rTMS Coil|"rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
150478|NCT01745952|O3|Outcome|Sham Coil; Then Figure-of-eight Active Coil; Then Round Active|"rTMS using the sham coil over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
150479|NCT01745952|O2|Outcome|Round Active Coil; Then Sham; Then Figure-of-eight Active Coil|"rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
150480|NCT01745952|O1|Outcome|Figure-of-eight Active Coil; Then Round Active Coil; Then Sham|"rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
150481|NCT01745952|O3|Outcome|Sham rTMS Coil (Figure-of-eight)|"rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
150482|NCT01745952|O2|Outcome|Round Active rTMS Coil|"rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
164955|NCT01694108|O2|Outcome|Control Children|No intervention
150485|NCT01745952|O3|Outcome|Sham rTMS Coil (Figure-of-eight)|"rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
150486|NCT01745952|O2|Outcome|Round Active rTMS Coil|"rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
150487|NCT01745952|O1|Outcome|Figure-of-eight Active rTMS Coil|"rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
150488|NCT01745952|O3|Outcome|Sham rTMS Coil (Figure-of-eight)|"rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered"
150489|NCT01745952|O2|Outcome|Round Active rTMS Coil|"rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered"
150490|NCT01745952|O1|Outcome|Figure-of-eight Active rTMS Coil|"rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
150491|NCT01745952|O3|Outcome|Sham Coil; Then Figure-of-eight Active Coil; Then Round Active|"rTMS using the sham coil over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
150492|NCT01745952|O2|Outcome|Round Active Coil; Then Sham; Then Figure-of-eight Active Coil|"rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
150493|NCT01745952|O1|Outcome|Figure-of-eight Active Coil; Then Round Active Coil; Then Sham|"rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
150494|NCT01745952|E3|Reported Event|Sham rTMS Coil (Figure-of-eight)|"rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, at 0.5 Hertz with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~sham rTMS coil (figure-of-eight): placebo coil that provides slight sensory stimulation and discharge noise without stimulating cortical tissue"
150495|NCT01745952|E2|Reported Event|Round Active rTMS Coil|"rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, at 0.5 Hertz with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~round active rTMS coil: navigated rTMS over epileptogenic focus using round active rTMS coil"
150496|NCT01745952|E1|Reported Event|Figure-of-eight Active rTMS Coil|"rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, at 0.5 Hertz with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~figure-of-eight active rTMS coil: navigated rTMS over epileptogenic focus using figure-of-eight active rTMS coil"
150497|NCT01745913|B3|Baseline|Total|Total of all reporting groups
150498|NCT01745913|B2|Baseline|UCB SCT|For the standard arm, UCB units will be selected using the Minnesota strategy and the strategy followed in a recent CTN study.17;19Each unit must supply a minimum of 1.5 x107/kg pre-cryopreserved nucleated cell dose. Subjects must have two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and –B and at high resolution for –DRB1.
150499|NCT01745913|B1|Baseline|Haplo-Cord SCT|The UCB unit must supply a minimum of 1.0 x107/kg pre-cryopreserved nucleated cell dose. The unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and –B and at high resolution for –DRB1.
150517|NCT01745380|P1|Participant Flow|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
150518|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
150500|NCT01745913|P2|Participant Flow|UCB SCT|For the standard arm, UCB units will be selected using the Minnesota strategy and the strategy followed in a recent CTN study.17;19Each unit must supply a minimum of 1.5 x107/kg pre-cryopreserved nucleated cell dose. Subjects must have two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1 Fludarabine: Fludarabine: 30 mg/m2 /day intravenously x 5 days total dose 150 mg/m2. Fludarabine will be dosed according to actual body weight Melphalan: Melphalan: 70mg/m2/day intravenously x 2 days. Melphalan will be dosed according to actual body weight.
150501|NCT01745913|P1|Participant Flow|Haplo-Cord SCT|"The UCB unit must supply a minimum of 1.0 x107/kg pre-cryopreserved nucleated cell dose. The unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1~CliniMACS® CD34 Reagent System: If a subject is randomized to the haplo-cord transplant group, their family member will undergo a stem cell collection. The stem cells from the haplo-identical donor will be purified by a procedure called CD34 selection before they are given to the subject. A special device called the CliniMACS® CD34 Reagent System, which is not FDA approved, will be used for this purpose."
150502|NCT01745913|O2|Outcome|UCB SCT|"For the standard arm, UCB units will be selected using the Minnesota strategy and the strategy followed in a recent CTN study.17;19Each unit must supply a minimum of 1.5 x107/kg pre-cryopreserved nucleated cell dose. Subjects must have two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1~Fludarabine: Fludarabine: 30 mg/m2 /day intravenously x 5 days total dose 150 mg/m2. Fludarabine will be dosed according to actual body weight~Melphalan: Melphalan: 70mg/m2/day intravenously x 2 days. Melphalan will be dosed according to actual body weight. Cryotherapy with ice chips will be administered to prevent mucosit"
150503|NCT01745913|O1|Outcome|Haplo-Cord SCT|"The UCB unit must supply a minimum of 1.0 x107/kg pre-cryopreserved nucleated cell dose. The unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1~CliniMACS® CD34 Reagent System: If a subject is randomized to the haplo-cord transplant group, their family member will undergo a stem cell collection. The stem cells from the haplo-identical donor will be purified by a procedure called CD34 selection before they are given to the subject. A special device called the CliniMACS® CD34 Reagent System, which is not FDA approved, will be used for this purpose. The manufacturer of the device, Miltenyi Biotec, is providing the researchers access to the device for"
150504|NCT01745913|O2|Outcome|UCB SCT|For the standard arm, UCB units will be selected using the Minnesota strategy and the strategy followed in a recent CTN study.17;19Each unit must supply a minimum of 1.5 x107/kg pre-cryopreserved nucleated cell dose. Subjects must have two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and –B and at high resolution for –DRB1.
150505|NCT01745913|O1|Outcome|Haplo-Cord SCT|The UCB unit must supply a minimum of 1.0 x107/kg pre-cryopreserved nucleated cell dose. The unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and –B and at high resolution for –DRB1.
150506|NCT01745913|E2|Reported Event|UCB SCT|For the standard arm, UCB units will be selected using the Minnesota strategy and the strategy followed in a recent CTN study.17;19Each unit must supply a minimum of 1.5 x107/kg pre-cryopreserved nucleated cell dose. Subjects must have two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and –B and at high resolution for –DRB1.
150507|NCT01745913|E1|Reported Event|Haplo-Cord SCT|The UCB unit must supply a minimum of 1.0 x107/kg pre-cryopreserved nucleated cell dose. The unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and –B and at high resolution for –DRB1.
150508|NCT01745848|B1|Baseline|Roflumilast|Roflumilast 500 μcg, once daily, for 30 days
150509|NCT01745848|P1|Participant Flow|Roflumilast|"Roflumilast 500 μcg, once daily, for 30 days~Roflumilast"
150510|NCT01745848|O1|Outcome|Roflumilast|Roflumilast 500 μcg, once daily, for 30 days
150511|NCT01745848|O1|Outcome|Roflumilast|Roflumilast 500 μcg, once daily, for 30 days
150512|NCT01745848|E1|Reported Event|Roflumilast|Roflumilast 500 μcg, once daily, for 30 days
150513|NCT01745380|B3|Baseline|Total|Total of all reporting groups
150514|NCT01745380|B2|Baseline|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
150515|NCT01745380|B1|Baseline|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
151926|NCT01738971|B2|Baseline|Rapid Access|"rapid access to family planning service~rapid access to contraceptive service"
150521|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
150522|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
150523|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
150524|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
150525|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
150526|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
150527|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
150528|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
150529|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
150530|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
150531|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
150532|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
150533|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
150534|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
150535|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
150536|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
150537|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
150538|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
150539|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
150540|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
150541|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
150542|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
150543|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
150544|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
150545|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
150546|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
150547|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
150548|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
150549|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
150550|NCT01745380|E2|Reported Event|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
150551|NCT01745380|E1|Reported Event|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
150553|NCT01745133|B3|Baseline|Calcipotriene + Clobetasol Propionate 20|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks~calcipotriene + clobetasol propionate: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks"
150554|NCT01745133|B2|Baseline|Calcipotriene 20|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x~calcipotriene: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks"
150555|NCT01745133|B1|Baseline|Vehicle 19|"clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks~vehicle foam: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks"
150556|NCT01745133|P3|Participant Flow|Calcipotriene + Clobetasol Propionate 20|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks~calcipotriene + clobetasol propionate: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks"
150557|NCT01745133|P2|Participant Flow|Calcipotriene 20|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x~calcipotriene: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks"
150558|NCT01745133|P1|Participant Flow|Vehicle 19|"clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks~vehicle foam: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks"
150559|NCT01745133|O3|Outcome|Calcipotriene + Clobetasol Propionate 79%|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks~calcipotriene + clobetasol propionate: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks"
150560|NCT01745133|O2|Outcome|Calcipotriene 80%|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x~calcipotriene: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks"
150561|NCT01745133|O1|Outcome|Vehicle 68%|"clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks~vehicle foam: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks"
150562|NCT01745133|E3|Reported Event|Calcipotriene + Clobetasol Propionate 79%|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks~calcipotriene + clobetasol propionate: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks"
150563|NCT01745133|E2|Reported Event|Calcipotriene 80%|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x~calcipotriene: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks"
150564|NCT01745133|E1|Reported Event|Vehicle|"clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks~vehicle foam: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks"
150565|NCT01745094|B5|Baseline|Total|Total of all reporting groups
150566|NCT01745094|B4|Baseline|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
150567|NCT01745094|B3|Baseline|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150568|NCT01745094|B2|Baseline|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.
150569|NCT01745094|B1|Baseline|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150570|NCT01745094|P4|Participant Flow|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
150571|NCT01745094|P3|Participant Flow|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150572|NCT01745094|P2|Participant Flow|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.
150573|NCT01745094|P1|Participant Flow|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150574|NCT01745094|O4|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|"Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg."
150575|NCT01745094|O3|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150576|NCT01745094|O2|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.
150577|NCT01745094|O1|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
157648|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
150578|NCT01745094|O4|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
150579|NCT01745094|O3|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Patients received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150580|NCT01745094|O2|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.
150581|NCT01745094|O1|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Patients received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150582|NCT01745094|O4|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
150583|NCT01745094|O3|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150584|NCT01745094|O2|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.
150585|NCT01745094|O1|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150586|NCT01745094|O4|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
150587|NCT01745094|O3|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150588|NCT01745094|O2|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.
150589|NCT01745094|O1|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150590|NCT01745094|O4|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
150591|NCT01745094|O3|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150592|NCT01745094|O2|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.
150593|NCT01745094|O1|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150594|NCT01745094|O4|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
150595|NCT01745094|O3|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150596|NCT01745094|O2|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.
150597|NCT01745094|O1|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150598|NCT01745094|O4|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
150599|NCT01745094|O3|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150600|NCT01745094|O2|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.
150601|NCT01745094|O1|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150602|NCT01745094|O4|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
150603|NCT01745094|O3|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150604|NCT01745094|O2|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.
150605|NCT01745094|O1|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150606|NCT01745094|O4|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
150607|NCT01745094|O3|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150608|NCT01745094|O2|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.
150609|NCT01745094|O1|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150610|NCT01745094|O4|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
150611|NCT01745094|O3|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150612|NCT01745094|O2|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.
150613|NCT01745094|O1|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150614|NCT01745094|O4|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
150615|NCT01745094|O3|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150616|NCT01745094|O2|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.
150617|NCT01745094|O1|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150618|NCT01745094|O4|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
150619|NCT01745094|O3|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150620|NCT01745094|O2|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.
150621|NCT01745094|O1|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150622|NCT01745094|O4|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
150623|NCT01745094|O3|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150624|NCT01745094|O2|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.
150625|NCT01745094|O1|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150626|NCT01745094|O4|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
150627|NCT01745094|O3|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150628|NCT01745094|O2|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.
150629|NCT01745094|O1|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150630|NCT01745094|O4|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
150631|NCT01745094|O3|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150632|NCT01745094|O2|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.
150633|NCT01745094|O1|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150634|NCT01745094|E4|Reported Event|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
150635|NCT01745094|E3|Reported Event|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150636|NCT01745094|E2|Reported Event|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.
150637|NCT01745094|E1|Reported Event|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
150638|NCT01745055|B1|Baseline|Methotrexate + CP-690,550|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice); followed by CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6; followed by single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
150639|NCT01745055|P1|Participant Flow|Methotrexate + CP-690,550|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice); followed by CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6; followed by single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
150640|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
150641|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice).
150642|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
150643|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of MTX on Day 1 (15-25 milligram [mg], as per local prescribing practice).
150644|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
150645|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
150646|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
150647|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
150648|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
150649|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice).
150650|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
150651|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of MTX on Day 1 (15-25 milligram [mg], as per local prescribing practice).
150652|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
150653|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice).
150654|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
150655|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
150656|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
150657|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
150658|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
150659|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
150660|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
150661|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice).
150662|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
150663|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of MTX on Day 1 (15-25 milligram [mg], as per local prescribing practice).
150664|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
150665|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
150666|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
150667|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
150668|NCT01745055|E3|Reported Event|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
150669|NCT01745055|E2|Reported Event|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
150670|NCT01745055|E1|Reported Event|Methotrexate|Single oral dose of MTX on Day 1 (15-25 mg), as per local prescribing practice.
150671|NCT01744977|B3|Baseline|Total|Total of all reporting groups
150672|NCT01744977|B2|Baseline|Education Only Group|Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed.
150673|NCT01744977|B1|Baseline|Adherence Packaging Intervention Group|"[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.~packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles"
151059|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
150674|NCT01744977|P2|Participant Flow|Education Only Group|Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed.
150675|NCT01744977|P1|Participant Flow|Adherence Packaging Intervention Group|"[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA (Research Assistant) on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.~packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles"
150676|NCT01744977|O2|Outcome|Education Only Group|Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed.
150677|NCT01744977|O1|Outcome|Adherence Packaging Intervention Group|"[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.~packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles"
150678|NCT01744977|O2|Outcome|Education Only Group|Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed.
150679|NCT01744977|O1|Outcome|Adherence Packaging Intervention Group|"[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.~packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles"
150680|NCT01744977|E2|Reported Event|Education Only Group|Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed.
150681|NCT01744977|E1|Reported Event|Adherence Packaging Intervention Group|"[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.~packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles"
150682|NCT01744860|B1|Baseline|Melanoma Tumor Sample With BRAF V600 Mutation|BRAF V600 mutations were analysed in melanoma tumor samples using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods and Cobas 4800 mutation test
150683|NCT01744860|P1|Participant Flow|Melanoma Tumor Sample With BRAF V600 Mutation|BRAF V600 mutations were analysed in melanoma tumor samples using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods and Cobas 4800 mutation test
150684|NCT01744860|O1|Outcome|Final Result- Discordant Samples|This included 28 samples out of 420 samples, whose BRAF V600 mutation results, by INCa “in House” Methods and cobas 4800 BRAF V600 mutation test did not show similar outcome.
150685|NCT01744860|O1|Outcome|Discordant Group|This included 28 samples out of 420 samples, whose BRAF V600 mutation results, by INCa “in House” Methods and cobas 4800 BRAF V600 mutation test did not show similar outcome.
150686|NCT01744860|O1|Outcome|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
150687|NCT01744860|O1|Outcome|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
150688|NCT01744860|O1|Outcome|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
150689|NCT01744860|O1|Outcome|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
150690|NCT01744860|O1|Outcome|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
150691|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
150692|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
150693|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
150694|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
150695|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
150696|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
150697|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “in House” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
150698|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
150699|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
150700|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
150701|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
150702|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
150703|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
150704|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
150705|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
150706|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
150707|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
150708|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
150709|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
150710|NCT01744860|O1|Outcome|Overall Tumour Samples|A total of 420 melanoma samples (surgical specimens or biopsies of primary tumours or metastases) were included in analysis. The samples were collected either from External pathology laboratories or Internal pathology laboratories
150711|NCT01744860|O1|Outcome|Overall Tumour Samples|A total of 420 melanoma samples (surgical specimens or biopsies of primary tumours or metastases) were included in analysis. The samples were collected either from External pathology laboratories or Internal pathology laboratories
150712|NCT01744860|O2|Outcome|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
150713|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “in House” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
150714|NCT01744860|E2|Reported Event|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
150715|NCT01744860|E1|Reported Event|INCa Molecular Genetics Laboratory “in House” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using in-house methods
150716|NCT01744821|B5|Baseline|Total|Total of all reporting groups
150717|NCT01744821|B4|Baseline|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
150718|NCT01744821|B3|Baseline|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
150719|NCT01744821|B2|Baseline|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
150720|NCT01744821|B1|Baseline|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
150721|NCT01744821|P4|Participant Flow|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
150722|NCT01744821|P3|Participant Flow|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
150723|NCT01744821|P2|Participant Flow|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
150724|NCT01744821|P1|Participant Flow|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
150725|NCT01744821|O4|Outcome|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
150726|NCT01744821|O3|Outcome|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
150727|NCT01744821|O2|Outcome|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
150728|NCT01744821|O1|Outcome|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
150729|NCT01744821|O4|Outcome|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
150730|NCT01744821|O3|Outcome|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
150731|NCT01744821|O2|Outcome|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
150732|NCT01744821|O1|Outcome|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
150733|NCT01744821|O4|Outcome|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
150734|NCT01744821|O3|Outcome|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
150735|NCT01744821|O2|Outcome|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
150736|NCT01744821|O1|Outcome|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
150737|NCT01744821|O4|Outcome|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
150738|NCT01744821|O3|Outcome|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
150739|NCT01744821|O2|Outcome|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
150740|NCT01744821|O1|Outcome|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
150741|NCT01744821|E4|Reported Event|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
150742|NCT01744821|E3|Reported Event|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
150743|NCT01744821|E2|Reported Event|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
150744|NCT01744821|E1|Reported Event|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
150745|NCT01744782|B1|Baseline|RP103|From Day 1 and throughout the duration of participation, RP103 (Cysteamine Bitartrate Delayed-release Capsules) was administered every 12 hours (Q12H), supplied as 75 mg and 25 mg capsules.
150746|NCT01744782|P1|Participant Flow|RP103|From Day 1 and throughout the duration of participation, RP103 (Cysteamine Bitartrate Delayed-release Capsules) was administered every 12 hours (Q12H), supplied as 75 mg and 25 mg capsules.
150747|NCT01744782|O1|Outcome|RP103|From Day 1 and throughout the duration of participation, RP103 (Cysteamine Bitartrate Delayed-release Capsules) was administered every 12 hours (Q12H), supplied as 75 mg and 25 mg capsules.
150748|NCT01744782|O1|Outcome|RP103|From Day 1 and throughout the duration of participation, RP103 (Cysteamine Bitartrate Delayed-release Capsules) was administered every 12 hours (Q12H), supplied as 75 mg and 25 mg capsules.
150749|NCT01744782|O1|Outcome|RP103|From Day 1 and throughout the duration of participation, RP103 (Cysteamine Bitartrate Delayed-release Capsules) was administered every 12 hours (Q12H), supplied as 75 mg and 25 mg capsules.
150750|NCT01744782|O1|Outcome|RP103|From Day 1 and throughout the duration of participation, RP103 (Cysteamine Bitartrate Delayed-release Capsules) was administered every 12 hours (Q12H), supplied as 75 mg and 25 mg capsules.
150751|NCT01744782|O1|Outcome|RP103|From Day 1 and throughout the duration of participation, RP103 (Cysteamine Bitartrate Delayed-release Capsules) was administered every 12 hours (Q12H), supplied as 75 mg and 25 mg capsules.
150752|NCT01744782|E1|Reported Event|RP103|From Day 1 and throughout the duration of participation, RP103 (Cysteamine Bitartrate Delayed-release Capsules) was administered every 12 hours (Q12H), supplied as 75 mg and 25 mg capsules.
150753|NCT01744730|B6|Baseline|Total|Total of all reporting groups
150754|NCT01744730|B5|Baseline|Patients Less Than 21 Years of Age (NCT01431326)|Standard of care clindamycin administration
150755|NCT01744730|B4|Baseline|Clindamycin IV-ages 12 to 17 (BMI Greater Than 95th)|Clindamycin IV: Children ages 12 to 17 years old with BMI greater than 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
150756|NCT01744730|B3|Baseline|Clinidamycin IV-ages 12 to 17 (BMI 85-95th Percentile)|Clindamycin IV: Children ages 12 to 17 years old with BMI 85th to 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
150757|NCT01744730|B2|Baseline|Clindamycin IV-ages 2 to 11 Years Old (BMI Greater Than 95th)|Clindamycin IV: Children ages 2 to 11 years old with BMI greater than 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
150758|NCT01744730|B1|Baseline|Clindamycin IV-ages 2 to 11 Years Old (BMI 85-95th Percentile)|Clindamycin IV: Children ages 2 to 11 years old with BMI 85th to 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
150759|NCT01744730|P5|Participant Flow|Patients Less Than 21 Years of Age (NCT01431326)|Standard of care clindamycin administration.
151060|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
150760|NCT01744730|P4|Participant Flow|Clindamycin IV-ages 12 to 17 (BMI Greater Than 95th)|Clindamycin IV: Children ages 12 to 17 years old with BMI greater than 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
150761|NCT01744730|P3|Participant Flow|Clinidamycin IV-ages 12 to 17 (BMI 85-95th Percentile)|Clindamycin IV: Children ages 12 to 17 years old with BMI 85th to 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
150762|NCT01744730|P2|Participant Flow|Clindamycin IV-ages 2 to 11 Years Old (BMI Greater Than 95th)|Clindamycin IV: Children ages 2 to 11 years old with BMI greater than 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
150763|NCT01744730|P1|Participant Flow|Clindamycin IV-ages 2 to 11 Years Old (BMI 85-95th Percentile)|Clindamycin IV: Children ages 2 to 11 years old with BMI 85th to 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
150764|NCT01744730|O6|Outcome|Clindamycin- Age >12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
150765|NCT01744730|O5|Outcome|Clindamycin- Age >12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
150766|NCT01744730|O4|Outcome|Clindamycin- Ages >6 to 12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
150767|NCT01744730|O3|Outcome|Clindamycin- Ages >6 to 12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
150768|NCT01744730|O2|Outcome|Clindamycin- Ages >2 to 6 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
150769|NCT01744730|O1|Outcome|Clindamycin- Ages >2 to 6 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
150770|NCT01744730|O6|Outcome|Clindamycin- Age >12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
150771|NCT01744730|O5|Outcome|Clindamycin- Age >12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
150772|NCT01744730|O4|Outcome|Clindamycin- Ages >6 to 12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
150773|NCT01744730|O3|Outcome|Clindamycin- Ages >6 to 12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
150774|NCT01744730|O2|Outcome|Clindamycin- Ages >2 to 6 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
150775|NCT01744730|O1|Outcome|Clindamycin- Ages >2 to 6 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
150776|NCT01744730|O6|Outcome|Clindamycin- Age >12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
150777|NCT01744730|O5|Outcome|Clindamycin- Age >12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
150778|NCT01744730|O4|Outcome|Clindamycin- Ages >6 to 12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
150779|NCT01744730|O3|Outcome|Clindamycin- Ages >6 to 12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
150780|NCT01744730|O2|Outcome|Clindamycin- Ages >2 to 6 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
150781|NCT01744730|O1|Outcome|Clindamycin- Ages >2 to 6 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
150782|NCT01744730|O6|Outcome|Clindamycin- Age >12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
150783|NCT01744730|O5|Outcome|Clindamycin- Age >12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
150784|NCT01744730|O4|Outcome|Clindamycin- Ages >6 to 12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
150785|NCT01744730|O3|Outcome|Clindamycin- Ages >6 to 12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
150786|NCT01744730|O2|Outcome|Clindamycin- Ages >2 to 6 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
150787|NCT01744730|O1|Outcome|Clindamycin- Ages >2 to 6 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
150788|NCT01744730|O6|Outcome|Clindamycin- Age >12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
150789|NCT01744730|O5|Outcome|Clindamycin- Age >12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
150790|NCT01744730|O4|Outcome|Clindamycin- Ages >6 to 12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
150791|NCT01744730|O3|Outcome|Clindamycin- Ages >6 to 12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
150792|NCT01744730|O2|Outcome|Clindamycin- Ages >2 to 6 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
150793|NCT01744730|O1|Outcome|Clindamycin- Ages >2 to 6 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
150794|NCT01744730|O6|Outcome|Clindamycin- Age >12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
150795|NCT01744730|O5|Outcome|Clindamycin- Age >12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
150796|NCT01744730|O4|Outcome|Clindamycin- Ages >6 to 12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
150797|NCT01744730|O3|Outcome|Clindamycin- Ages >6 to 12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
150798|NCT01744730|O2|Outcome|Clindamycin- Ages >2 to 6 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
150799|NCT01744730|O1|Outcome|Clindamycin- Ages >2 to 6 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
150800|NCT01744730|E5|Reported Event|Patients Less Than 21 Years of Age (NCT01431326)|Standard of care clindamycin administration
150801|NCT01744730|E4|Reported Event|Clindamycin IV-ages 12 to 17 (BMI Greater Than or Equal 95th)|"Clindamycin IV: Children ages 12 to 17 years old with BMI greater than or equal 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.~Clindamycin PO: Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 g/day. Dosing greater than 2.7 g/day was allowed for children receiving clindamycin as part of clinical care."
150802|NCT01744730|E3|Reported Event|Clinidamycin IV-ages 12 to 17 (BMI 85- <95th Percentile)|"Clindamycin IV: Children ages 12 to 17 years old with BMI 85th to <95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.~Clindamycin PO: Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 g/day. Dosing greater than 2.7 g/day was allowed for children receiving clindamycin as part of clinical care."
150803|NCT01744730|E2|Reported Event|Clindamycin IV-ages 2 to 11 (BMI Greater Than or Equal 95th)|"Clindamycin IV: Children ages 2 to 11 years old with BMI greater than or equal 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.~Clindamycin PO: Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 g/day. Dosing greater than 2.7 g/day was allowed for children receiving clindamycin as part of clinical care."
150804|NCT01744730|E1|Reported Event|Clindamycin IV-ages 2 to 11 (BMI 85- <95th Percentile)|"Clindamycin IV: Children ages 2 to 11 years old with BMI 85th to <95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.~Clindamycin PO: Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 g/day. Dosing greater than 2.7 g/day was allowed for children receiving clindamycin as part of clinical care."
150805|NCT01744691|B1|Baseline|PCI-32765|"All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.~PCI-32765: All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily."
150806|NCT01744691|P1|Participant Flow|Ibrutinib|"All subjects received ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.~Ibrutinib: All subjects received ibrutinib 420 mg (3 x 140-mg capsules) orally once daily."
150807|NCT01744691|O1|Outcome|PCI-32765|"All subjects will receive PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.~PCI-32765: All subjects will receive PCI-32765 420 mg (3 x 140-mg capsules) orally once daily."
150808|NCT01744691|O1|Outcome|Ibrutinib|"All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.~ibrutinib: All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily."
150809|NCT01744691|E1|Reported Event|PCI-32765|"All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.~PCI-32765: All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily."
150810|NCT01744496|B3|Baseline|Total|Total of all reporting groups
150811|NCT01744496|B2|Baseline|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
150812|NCT01744496|B1|Baseline|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
150813|NCT01744496|P2|Participant Flow|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
150814|NCT01744496|P1|Participant Flow|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo will be decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
150868|NCT01744353|O2|Outcome|Experimental: Dose Level 2/ MTD|"Drug: Dose level 2/MTD Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
150869|NCT01744353|O1|Outcome|Experimental: Dose Level 1|"Drug: Dose level 1 Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
157649|NCT01718509|E2|Reported Event|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
150815|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
150816|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
150817|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
150818|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
150819|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
150820|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
150821|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
150822|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
150823|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
150824|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
150825|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
150826|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
150827|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
150828|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
150829|NCT01744496|E2|Reported Event|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
150830|NCT01744496|E1|Reported Event|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
150831|NCT01744483|B4|Baseline|Total|Total of all reporting groups
150832|NCT01744483|B3|Baseline|PUC-CASS ETT|"Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube~PUC-CASS ETT: Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation."
150833|NCT01744483|B2|Baseline|PUC ETT|"Polyurethane cuff endotracheal tube~PUC ETT: Placement of a PUC-cuffed ETT in the setting of emergent intubation."
150834|NCT01744483|B1|Baseline|PVC ETT|"Polyvinylchloride cuff endotracheal tube~PVC ETT: Placement of a PVC-cuffed ETT in the setting of emergent intubation."
150835|NCT01744483|P3|Participant Flow|PUC-CASS ETT|"Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube~PUC-CASS ETT: Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation."
150836|NCT01744483|P2|Participant Flow|PUC ETT|"Polyurethane cuff endotracheal tube~PUC ETT: Placement of a PUC-cuffed ETT in the setting of emergent intubation."
150837|NCT01744483|P1|Participant Flow|PVC ETT|"Polyvinylchloride cuff endotracheal tube~PVC ETT: Placement of a PVC-cuffed ETT in the setting of emergent intubation."
150838|NCT01744483|O3|Outcome|PUC-CASS ETT|"Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube~PUC-CASS ETT: Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation."
150839|NCT01744483|O2|Outcome|PUC ETT|"Polyurethane cuff endotracheal tube~PUC ETT: Placement of a PUC-cuffed ETT in the setting of emergent intubation."
150840|NCT01744483|O1|Outcome|PVC ETT|"Polyvinylchloride cuff endotracheal tube~PVC ETT: Placement of a PVC-cuffed ETT in the setting of emergent intubation."
150841|NCT01744483|E3|Reported Event|PUC-CASS ETT|"Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube~PUC-CASS ETT: Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation."
150842|NCT01744483|E2|Reported Event|PUC ETT|"Polyurethane cuff endotracheal tube~PUC ETT: Placement of a PUC-cuffed ETT in the setting of emergent intubation."
150843|NCT01744483|E1|Reported Event|PVC ETT|"Polyvinylchloride cuff endotracheal tube~PVC ETT: Placement of a PVC-cuffed ETT in the setting of emergent intubation."
151061|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
150844|NCT01744392|B1|Baseline|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
150845|NCT01744392|P1|Participant Flow|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
150846|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
150847|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
150848|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
150849|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
150850|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
150851|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
150852|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
150853|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
150854|NCT01744392|O1|Outcome|Education Intervention|The intervention provides a personalized Meducation calendar to all patients enrolled in the study. The Meducation Calendar includes medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication. Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study. The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development.
150855|NCT01744392|O1|Outcome|Education Intervention|The intervention provides a personalized Meducation calendar to all patients enrolled in the study. The Meducation Calendar includes medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication. Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study. The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development.
150856|NCT01744392|E1|Reported Event|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
150857|NCT01744353|B4|Baseline|Total|Total of all reporting groups
150858|NCT01744353|B3|Baseline|Experimental: Dose Level 3|"Drug: Dose level 3 Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
150859|NCT01744353|B2|Baseline|Experimental: Dose Level 2/ MTD|"Drug: Dose level 2/MTD Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
150860|NCT01744353|B1|Baseline|Experimental: Dose Level 1|"Drug: Dose level 1 Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
150861|NCT01744353|P3|Participant Flow|Experimental: Dose Level 3|Abraxane 175 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion
150862|NCT01744353|P2|Participant Flow|Experimental: Dose Level 2/ MTD|Abraxane 150 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion
150863|NCT01744353|P1|Participant Flow|Experimental: Dose Level 1|Abraxane 125 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion
150864|NCT01744353|O3|Outcome|Experimental: Dose Level 3|"Drug: Dose level 3 Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxan"
150865|NCT01744353|O2|Outcome|Experimental: Dose Level 2/ MTD|"Drug: Dose level 2/MTD Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
150866|NCT01744353|O1|Outcome|Experimental: Dose Level 1|"Drug: Dose level 1 Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
150867|NCT01744353|O3|Outcome|Experimental: Dose Level 3|"Drug: Dose level 3 Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxan"
151062|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
150870|NCT01744353|E1|Reported Event|FOLFOX- A|"FOLFOX-A Dose levels -1, 1, 2, 3: Three patients will be accrued to level 1. If no dose limiting toxicities (defined in section 5.2) are observed after two cycles of treatment, then accrual to level 2 will proceed. This procedure will continue until level 3 provided that the MTD has not been reached. If a DLT is observed in one of the first 3 patients in a dose level, then accrual for that level will be expanded to 6 patients. Two or more instances of DLT in a cohort of 6 patients will result in the preceding dose level being defined as the MTD. If dose level 1 is not tolerable then dose level -1 will be investigated. Once the MTD is found, the Principal Investigator will determine which dose should be assessed futher and an additional 10 patients will be treated.~FOLFOX-A: Three patients will be accrued to level 1. If no dose limiting toxicities (defined in section 5.2) are observed after two cycles of treatment, then accrual to level 2 will proceed. This procedure will continue un"
150871|NCT01744340|B3|Baseline|Total|Total of all reporting groups
150872|NCT01744340|B2|Baseline|Colon- Closed as of May 2014|"Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle~Colon- Closed as of May 2014: Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
150873|NCT01744340|B1|Baseline|Head and Neck|"Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2~Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter~Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
150874|NCT01744340|P2|Participant Flow|Colon- Closed as of May 2014|"Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle~Colon- Closed as of May 2014: Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
150875|NCT01744340|P1|Participant Flow|Head and Neck|"Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2~Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter~Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
150876|NCT01744340|O2|Outcome|Colon- Closed as of May 2014|"Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle~Colon- Closed as of May 2014: Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
150877|NCT01744340|O1|Outcome|Head and Neck|"Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2~Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter~Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
150878|NCT01744340|O2|Outcome|Colon- Closed as of May 2014|"Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle~Colon- Closed as of May 2014: Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
150879|NCT01744340|O1|Outcome|Head and Neck|"Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2~Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter~Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
150880|NCT01744340|E2|Reported Event|Colon- Closed as of May 2014|"Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle~Colon- Closed as of May 2014: Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
150881|NCT01744340|E1|Reported Event|Head and Neck|"Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2~Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter~Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
150882|NCT01744197|B3|Baseline|Total|Total of all reporting groups
150883|NCT01744197|B2|Baseline|Placebo First, Then Synera|Synera (lidocaine 70mg/tetracaine 70mg): All subjects received 2 patch applications, one Synera and one placebo. These 2 patch applications were done on separate days. Subjects in this arm received placebo patch for the first application (day 1), and then Synera for the second (day 2 or after).
150884|NCT01744197|B1|Baseline|Synera First, Then Placebo|Synera (lidocaine 70mg/tetracaine 70mg): All subjects received 2 patch applications, one Synera and one placebo. These 2 patch applications were done on separate days. Subjects in this arm received Synera patch for the first application (day 1), and then placebo for the second (day 2 or after).
150885|NCT01744197|P2|Participant Flow|Placebo First, Then Synera|Synera (lidocaine 70mg/tetracaine 70mg): All subjects received 2 patch applications, one Synera and one placebo. These 2 patch applications were done on separate days. Subjects in this arm received placebo patch for the first application (day 1), and then Synera for the second (day 2 or after).
150886|NCT01744197|P1|Participant Flow|Synera First, Then Placebo|Synera (lidocaine 70mg/tetracaine 70mg): All subjects received 2 patch applications, one Synera and one placebo. These 2 patch applications were done on separate days. Subjects in this arm received Synera patch for the first application (day 1), and then placebo for the second (day 2 or after).
150887|NCT01744197|O2|Outcome|Placebo|Treated with Placebo.
150888|NCT01744197|O1|Outcome|Synera|Treated with Synera.
150889|NCT01744197|O2|Outcome|Placebo|Treated with Placebo.
150890|NCT01744197|O1|Outcome|Synera|Treated with Synera.
150891|NCT01744197|O2|Outcome|Placebo|Treated with Placebo.
150892|NCT01744197|O1|Outcome|Synera|Treated with Synera.
150893|NCT01744197|E2|Reported Event|Placebo|Treated with Placebo
150894|NCT01744197|E1|Reported Event|Synera|Treated with Synera.
150895|NCT01743963|B3|Baseline|Total|Total of all reporting groups
150896|NCT01743963|B2|Baseline|Usual Care|"Clinicians' typical approach for GID monitoring~Usual Care: clinicians typical apporach for GID monitering"
151927|NCT01738971|B1|Baseline|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
150897|NCT01743963|B1|Baseline|Decision Support Intervention|"Clinical pharmacists mediated computerized decision support~Decision support: Clinical pharmacists mediated computerized decision support"
150898|NCT01743963|P2|Participant Flow|Usual Care|"Clinicians' typical approach for GID monitoring~Usual Care: clinicians typical apporach for GID monitering"
150899|NCT01743963|P1|Participant Flow|Decision Support Intervention|"Clinical pharmacists mediated computerized decision support~Decision support: Clinical pharmacists mediated computerized decision support"
150900|NCT01743963|O2|Outcome|Usual Care|"Clinicians' typical approach for GID monitoring~Usual Care: clinicians typical apporach for GID monitering"
150901|NCT01743963|O1|Outcome|Decision Support Intervention|"Clinical pharmacists mediated computerized decision support~Decision support: Clinical pharmacists mediated computerized decision support"
150902|NCT01743963|E2|Reported Event|Usual Care|"Clinicians' typical approach for GID monitoring~Usual Care: clinicians typical apporach for GID monitering"
150903|NCT01743963|E1|Reported Event|Decision Support Intervention|"Clinical pharmacists mediated computerized decision support~Decision support: Clinical pharmacists mediated computerized decision support"
150904|NCT01743729|B3|Baseline|Total|Total of all reporting groups
150905|NCT01743729|B2|Baseline|Placebo|
150906|NCT01743729|B1|Baseline|Lifitegrast|
150907|NCT01743729|P2|Participant Flow|Placebo|
150908|NCT01743729|P1|Participant Flow|Lifitegrast|
150909|NCT01743729|O2|Outcome|Placebo|
150910|NCT01743729|O1|Outcome|Lifitegrast|
150911|NCT01743729|O2|Outcome|Placebo|
150912|NCT01743729|O1|Outcome|Lifitegrast|
150913|NCT01743729|E2|Reported Event|Placebo|
150914|NCT01743729|E1|Reported Event|Lifitegrast|
150915|NCT01743521|B5|Baseline|Total|Total of all reporting groups
150916|NCT01743521|B4|Baseline|No Group Allocated|Early treatment discontinuation or non-responder
150917|NCT01743521|B3|Baseline|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150918|NCT01743521|B2|Baseline|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150919|NCT01743521|B1|Baseline|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150920|NCT01743521|P4|Participant Flow|No Group Allocated|Early treatment discontinuation or non-responder (participants in whom therapy was terminated at week 4 due to HCV RNA >1000 IU/mL or week 8 due to detectable HCV RNA)
150921|NCT01743521|P3|Participant Flow|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150922|NCT01743521|P2|Participant Flow|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150923|NCT01743521|P1|Participant Flow|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150924|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150988|NCT01743469|O1|Outcome|Hepatocellular Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
150925|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150926|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150927|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150928|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150929|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150930|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150931|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150932|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150933|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150934|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150935|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150989|NCT01743469|O4|Outcome|Gastric Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
164956|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
150936|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150937|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150938|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150939|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150940|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150941|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150942|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150943|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150944|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150945|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150946|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150990|NCT01743469|O3|Outcome|Renal Cell Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
150947|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150948|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150949|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150950|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150951|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150952|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150953|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150954|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150955|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150956|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150957|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150991|NCT01743469|O2|Outcome|Ovarian Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
150958|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150959|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150960|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150961|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150962|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150963|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150964|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150965|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150966|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150967|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150968|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150992|NCT01743469|O1|Outcome|Hepatocellular Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
164957|NCT01694108|O2|Outcome|Control Children|No intervention
150969|NCT01743521|E3|Reported Event|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150970|NCT01743521|E2|Reported Event|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150971|NCT01743521|E1|Reported Event|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
150972|NCT01743469|B5|Baseline|Total|Total of all reporting groups
150973|NCT01743469|B4|Baseline|Gastric Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
150974|NCT01743469|B3|Baseline|Renal Cell Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
150975|NCT01743469|B2|Baseline|Ovarian Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
150976|NCT01743469|B1|Baseline|Hepatocellular Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
150977|NCT01743469|P4|Participant Flow|Gastric Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
150978|NCT01743469|P3|Participant Flow|Renal Cell Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
150979|NCT01743469|P2|Participant Flow|Ovarian Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
150980|NCT01743469|P1|Participant Flow|Hepatocellular Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
150981|NCT01743469|O4|Outcome|Gastric Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
150982|NCT01743469|O3|Outcome|Renal Cell Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
150983|NCT01743469|O2|Outcome|Ovarian Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
150984|NCT01743469|O1|Outcome|Hepatocellular Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
150985|NCT01743469|O4|Outcome|Gastric Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
150986|NCT01743469|O3|Outcome|Renal Cell Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
150987|NCT01743469|O2|Outcome|Ovarian Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
151056|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
157650|NCT01718509|E1|Reported Event|PLACEBO|Administered once-daily, orally, for up to 12 weeks
150993|NCT01743469|O1|Outcome|Hepatocellular Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
150994|NCT01743469|O4|Outcome|Gastric Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
150995|NCT01743469|O3|Outcome|Renal Cell Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
150996|NCT01743469|O2|Outcome|Ovarian Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
150997|NCT01743469|O1|Outcome|Hepatocellular Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
150998|NCT01743469|O1|Outcome|Hepatocellular Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
150999|NCT01743469|O4|Outcome|Gastric Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
151000|NCT01743469|O3|Outcome|Renal Cell Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
151001|NCT01743469|O2|Outcome|Ovarian Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
151002|NCT01743469|O1|Outcome|Hepatocellular Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
151003|NCT01743469|O1|Outcome|Hepatocellular Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
151004|NCT01743469|O4|Outcome|Gastric Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
151005|NCT01743469|O3|Outcome|Renal Cell Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
151006|NCT01743469|O2|Outcome|Ovarian Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
151007|NCT01743469|O1|Outcome|Hepatocellular Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
151008|NCT01743469|O1|Outcome|Hepatocellular Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
151009|NCT01743469|O4|Outcome|Gastric Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
151010|NCT01743469|O3|Outcome|Renal Cell Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
151011|NCT01743469|O2|Outcome|Ovarian Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
151012|NCT01743469|O1|Outcome|Hepatocellular Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
151013|NCT01743469|E4|Reported Event|Gastric Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
151014|NCT01743469|E3|Reported Event|Renal Cell Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
151015|NCT01743469|E2|Reported Event|Ovarian Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
151016|NCT01743469|E1|Reported Event|Hepatocellular Carcinoma Cohort|"1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.~1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks."
151017|NCT01743092|B3|Baseline|Total|Total of all reporting groups
151018|NCT01743092|B2|Baseline|Tutorial Workbook Group Plus Webinar|"Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.~Webinar: Some clients will receive a webinar as part of their treatment.~Tutuorial workbook: A work book about their addiciton"
151019|NCT01743092|B1|Baseline|Tutorial Workbook|"Tutorial Workbook Group only receives a Tutorial Workbook Group~Tutuorial workbook: A work book about their addiciton"
151020|NCT01743092|P2|Participant Flow|Tutorial Workbook Group Plus Webinar|"Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.~Webinar: Some clients will receive a webinar as part of their treatment.~Tutuorial workbook: A work book about their addiciton"
151021|NCT01743092|P1|Participant Flow|Tutorial Workbook|"Tutorial Workbook Group only receives a Tutorial Workbook Group~Tutuorial workbook: A work book about their addiciton"
151022|NCT01743092|O2|Outcome|Tutorial Workbook Group Plus Webinar|"Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.~Webinar: Some clients will receive a webinar as part of their treatment.~Tutuorial workbook: A work book about their addiciton"
151023|NCT01743092|O1|Outcome|Tutorial Workbook|"Tutorial Workbook Group only receives a Tutorial Workbook Group~Tutuorial workbook: A work book about their addiciton"
151024|NCT01743092|O2|Outcome|Tutorial Workbook Group Plus Webinar|"Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.~Webinar: Some clients will receive a webinar as part of their treatment.~Tutuorial workbook: A work book about their addiciton"
151025|NCT01743092|O1|Outcome|Tutorial Workbook|"Tutorial Workbook Group only receives a Tutorial Workbook Group~Tutuorial workbook: A work book about their addiciton"
151026|NCT01743092|E2|Reported Event|Tutorial Workbook Group Plus Webinar|"Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.~Webinar: Some clients will receive a webinar as part of their treatment.~Tutuorial workbook: A work book about their addiciton"
151027|NCT01743092|E1|Reported Event|Tutorial Workbook|"Tutorial Workbook Group only receives a Tutorial Workbook Group~Tutuorial workbook: A work book about their addiciton"
151028|NCT01743027|B5|Baseline|Total|Total of all reporting groups
151029|NCT01743027|B4|Baseline|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151030|NCT01743027|B3|Baseline|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151031|NCT01743027|B2|Baseline|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151032|NCT01743027|B1|Baseline|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151033|NCT01743027|P4|Participant Flow|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151034|NCT01743027|P3|Participant Flow|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151035|NCT01743027|P2|Participant Flow|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151036|NCT01743027|P1|Participant Flow|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151037|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151038|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151039|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151040|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151041|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151042|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151043|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151044|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151045|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151046|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151047|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151048|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151049|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151050|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151051|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151052|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151053|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151054|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151055|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151063|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151064|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151065|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151066|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151067|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151068|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151069|NCT01743027|E4|Reported Event|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151070|NCT01743027|E3|Reported Event|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151071|NCT01743027|E2|Reported Event|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151072|NCT01743027|E1|Reported Event|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
151073|NCT01743001|B3|Baseline|Total|Total of all reporting groups
151074|NCT01743001|B2|Baseline|Placebo|Subjects receive macitentan-matching placebo, oral tablet, to be taken once daily
151075|NCT01743001|B1|Baseline|Macitentan|Subjects receive macitentan 10 mg, oral tablet, to be taken once daily
151076|NCT01743001|P2|Participant Flow|Placebo|Subjects receive macitentan-matching placebo, oral tablet, to be taken once daily
151077|NCT01743001|P1|Participant Flow|Macitentan|Subjects receive macitentan 10 mg, oral tablet, to be taken once daily
151078|NCT01743001|O2|Outcome|Placebo|Subjects receive macitentan-matching placebo, oral tablet, to be taken once daily
151079|NCT01743001|O1|Outcome|Macitentan|Subjects receive macitentan 10 mg, oral tablet, to be taken once daily
151080|NCT01743001|O2|Outcome|Placebo|Subjects receive macitentan-matching placebo, oral tablet, to be taken once daily
151081|NCT01743001|O1|Outcome|Macitentan|Subjects receive macitentan 10 mg, oral tablet, to be taken once daily
151082|NCT01743001|O2|Outcome|Placebo|Subjects receive macitentan-matching placebo, oral tablet, to be taken once daily
151083|NCT01743001|O1|Outcome|Macitentan|Subjects receive macitentan 10 mg, oral tablet, to be taken once daily
151084|NCT01743001|O2|Outcome|Placebo|Subjects receive macitentan-matching placebo, oral tablet, to be taken once daily
151085|NCT01743001|O1|Outcome|Macitentan|Subjects receive macitentan 10 mg, oral tablet, to be taken once daily
151086|NCT01743001|E2|Reported Event|Placebo|Subjects receive macitentan-matching placebo orally to be taken once daily. 112 subjects were exposed to placebo for 15.96 weeks on average.
151087|NCT01743001|E1|Reported Event|Macitentan|Subjects receive macitentan 10 mg orally to be taken once daily. 114 subjects were exposed to Macitentan 10 mg for 15.93 weeks on average.
151088|NCT01742936|B3|Baseline|Total|Total of all reporting groups
151089|NCT01742936|B2|Baseline|Cardiac Bypass|"Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.~CoaguChek: Hand held coagulation monitor.~Hospital Laboratory: Coagulation testing done by hospital laboratory."
151090|NCT01742936|B1|Baseline|Spinal Fusion|"Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.~CoaguChek: Hand held coagulation monitor.~Hospital Laboratory: Coagulation testing done by hospital laboratory."
151091|NCT01742936|P2|Participant Flow|Cardiac Bypass|Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
151092|NCT01742936|P1|Participant Flow|Spinal Fusion|"Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.~CoaguChek~Hospital Laboratory"
151093|NCT01742936|O2|Outcome|Cardiac Bypass|Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
151094|NCT01742936|O1|Outcome|Spinal Fusion|"Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.~CoaguChek~Hospital Laboratory"
151095|NCT01742936|O2|Outcome|Cardiac Bypass|Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
151096|NCT01742936|O1|Outcome|Spinal Fusion|"Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.~CoaguChek~Hospital Laboratory"
151097|NCT01742936|E2|Reported Event|Cardiac Bypass|Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
151098|NCT01742936|E1|Reported Event|Spinal Fusion|"Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.~CoaguChek~Hospital Laboratory"
151099|NCT01742897|B1|Baseline|TTS-Fentanyl|Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
151100|NCT01742897|P1|Participant Flow|TTS-Fentanyl|Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
151101|NCT01742897|O1|Outcome|TTS-Fentanyl|Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
151102|NCT01742897|E1|Reported Event|TTS-Fentanyl|Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
151103|NCT01742832|B3|Baseline|Total|Total of all reporting groups
151135|NCT01742364|O2|Outcome|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
151136|NCT01742364|O1|Outcome|Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
157651|NCT01718483|B3|Baseline|Total|Total of all reporting groups
151104|NCT01742832|B2|Baseline|Citalopram|"For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.~Citalopram: For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day."
151105|NCT01742832|B1|Baseline|Vilazodone|"A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.~Vilazodone: A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day."
151106|NCT01742832|P2|Participant Flow|Citalopram|"For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.~Citalopram: For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day."
151107|NCT01742832|P1|Participant Flow|Vilazodone|"A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.~Vilazodone: A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day."
151108|NCT01742832|O2|Outcome|Citalopram|"For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.~Citalopram: For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day."
151109|NCT01742832|O1|Outcome|Vilazodone|"A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.~Vilazodone: A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day."
151110|NCT01742832|E2|Reported Event|Citalopram|"For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.~Citalopram: For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day."
151111|NCT01742832|E1|Reported Event|Vilazodone|"A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.~Vilazodone: A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day."
151112|NCT01742364|B5|Baseline|Total|Total of all reporting groups
151113|NCT01742364|B4|Baseline|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
151114|NCT01742364|B3|Baseline|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
151115|NCT01742364|B2|Baseline|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
151116|NCT01742364|B1|Baseline|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
151117|NCT01742364|P4|Participant Flow|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
151118|NCT01742364|P3|Participant Flow|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
151119|NCT01742364|P2|Participant Flow|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
151120|NCT01742364|P1|Participant Flow|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
151121|NCT01742364|O4|Outcome|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
151122|NCT01742364|O3|Outcome|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
151123|NCT01742364|O2|Outcome|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
151124|NCT01742364|O1|Outcome|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
151125|NCT01742364|O4|Outcome|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
151126|NCT01742364|O3|Outcome|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
151127|NCT01742364|O2|Outcome|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
151128|NCT01742364|O1|Outcome|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
151129|NCT01742364|O2|Outcome|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
151130|NCT01742364|O1|Outcome|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
151131|NCT01742364|O2|Outcome|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
151132|NCT01742364|O1|Outcome|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
151133|NCT01742364|O4|Outcome|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
151134|NCT01742364|O3|Outcome|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
151137|NCT01742364|O4|Outcome|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
151138|NCT01742364|O3|Outcome|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
151139|NCT01742364|O2|Outcome|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
151140|NCT01742364|O1|Outcome|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
151141|NCT01742364|E4|Reported Event|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
151142|NCT01742364|E3|Reported Event|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
151143|NCT01742364|E2|Reported Event|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
151144|NCT01742364|E1|Reported Event|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
151145|NCT01741792|B4|Baseline|Total|Total of all reporting groups
151146|NCT01741792|B3|Baseline|Cohort 3: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151147|NCT01741792|B2|Baseline|Cohort 2: Blinatumomab 112 µg/d|Participants received blinatumomab administered CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151148|NCT01741792|B1|Baseline|Cohort 1: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151149|NCT01741792|P3|Participant Flow|Cohort 3: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151150|NCT01741792|P2|Participant Flow|Cohort 2: Blinatumomab 112 µg/d|Participants received blinatumomab administered CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151151|NCT01741792|P1|Participant Flow|Cohort 1: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151152|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151153|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151154|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151155|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151156|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151157|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151158|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151159|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151160|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151161|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151162|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151163|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151164|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151165|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151166|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151167|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151168|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151169|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151170|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151171|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151172|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151173|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151174|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151175|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151176|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151177|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151178|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151179|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151180|NCT01741792|O3|Outcome|Blinatumomab 112 μg/d|Participants received blinatumomab administered CIV 112 µg/day.
151181|NCT01741792|O2|Outcome|Blinatumomab 28 μg/d|Participants received blinatumomab CIV 28 µg/day.
151182|NCT01741792|O1|Outcome|Blinatumomab 9 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day.
151183|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151184|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151185|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151186|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151187|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151188|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151189|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151190|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151191|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151192|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151193|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151194|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151928|NCT01738971|P3|Participant Flow|Progestogen Only Pill|"one month progestogen only pill~one month progestogen only pill"
151195|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151196|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151197|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151198|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151199|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151200|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151201|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151202|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151203|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151204|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151205|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151206|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151207|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151208|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151209|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151210|NCT01741792|E5|Reported Event|Blinatumomab Overall|All participants who received blinatumomab by continuous intravenous infusion during the core study.
151472|NCT01740817|E1|Reported Event|Saline|Intralipid infusion 20%, at 30 ml/h for 48 h, then washout 4-6 weeks, then saline 30 ml/h for 48 h
151473|NCT01740726|B3|Baseline|Total|Total of all reporting groups
151211|NCT01741792|E4|Reported Event|Cohort 1+3: Blinatumomab 9/28/112µg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151212|NCT01741792|E3|Reported Event|Cohort 3: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151213|NCT01741792|E2|Reported Event|Cohort 2: Blinatumomab 112 µg/d|Participants received blinatumomab administered CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151214|NCT01741792|E1|Reported Event|Cohort 1: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
151215|NCT01741701|B3|Baseline|Total|Total of all reporting groups
151216|NCT01741701|B2|Baseline|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
151217|NCT01741701|B1|Baseline|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
151218|NCT01741701|P2|Participant Flow|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
151219|NCT01741701|P1|Participant Flow|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
151220|NCT01741701|O2|Outcome|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
151221|NCT01741701|O1|Outcome|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
151222|NCT01741701|O2|Outcome|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
151223|NCT01741701|O1|Outcome|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
151224|NCT01741701|O2|Outcome|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
151225|NCT01741701|O1|Outcome|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
151226|NCT01741701|O2|Outcome|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
151227|NCT01741701|O1|Outcome|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
151228|NCT01741701|O2|Outcome|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
151229|NCT01741701|O1|Outcome|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
151230|NCT01741701|O2|Outcome|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
151231|NCT01741701|O1|Outcome|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
151232|NCT01741701|E2|Reported Event|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
151233|NCT01741701|E1|Reported Event|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
151234|NCT01741688|B1|Baseline|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
151235|NCT01741688|P1|Participant Flow|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
151236|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
151237|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
151238|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
151239|NCT01741688|O1|Outcome|Cohort|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
151240|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
158731|NCT01716221|O1|Outcome|Baseline - Unblinded on Buproprion and Citalopram|
151241|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
151242|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
151243|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
151244|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
151245|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
151246|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
151247|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
151248|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
151249|NCT01741688|O1|Outcome|Cohort|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
151250|NCT01741688|E1|Reported Event|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
151251|NCT01741350|B3|Baseline|Total|Total of all reporting groups
151252|NCT01741350|B2|Baseline|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151253|NCT01741350|B1|Baseline|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151254|NCT01741350|P2|Participant Flow|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151401|NCT01741272|O2|Outcome|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
151402|NCT01741272|O1|Outcome|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
151403|NCT01741272|E2|Reported Event|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
164958|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
151255|NCT01741350|P1|Participant Flow|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151256|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151257|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151258|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151259|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151260|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151261|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151262|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151404|NCT01741272|E1|Reported Event|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
151405|NCT01741259|B3|Baseline|Total|Total of all reporting groups
151406|NCT01741259|B2|Baseline|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151407|NCT01741259|B1|Baseline|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
158732|NCT01716221|O5|Outcome|Baseline|unblinded 100mg Bupropion & 20mg Citalopram
151263|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151264|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151265|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151266|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151267|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151268|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151269|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151270|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151408|NCT01741259|P2|Participant Flow|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151409|NCT01741259|P1|Participant Flow|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
151410|NCT01741259|O2|Outcome|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151411|NCT01741259|O1|Outcome|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
164959|NCT01694108|O2|Outcome|Control Children|No intervention
151271|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151272|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151273|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151274|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151275|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151276|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151277|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151278|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151412|NCT01741259|O2|Outcome|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151413|NCT01741259|O1|Outcome|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
151414|NCT01741259|O2|Outcome|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151415|NCT01741259|O1|Outcome|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
158797|NCT01716013|O1|Outcome|BondEase|"Topical Skin Adhesive~BondEase: topical skin adhesive"
151279|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151280|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151281|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151282|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151283|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151284|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151285|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151286|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151416|NCT01741259|O2|Outcome|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151417|NCT01741259|O1|Outcome|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
151418|NCT01741259|O2|Outcome|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151419|NCT01741259|O1|Outcome|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
158911|NCT01715415|B3|Baseline|Total|Total of all reporting groups
151287|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151288|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151289|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151290|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151291|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151292|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151293|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151294|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151420|NCT01741259|O2|Outcome|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151421|NCT01741259|O1|Outcome|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
151422|NCT01741259|O2|Outcome|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151423|NCT01741259|O1|Outcome|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
158912|NCT01715415|B2|Baseline|Placebo|Double-blind placebo for 12 weeks
151295|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151296|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151297|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151298|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151299|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151300|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151301|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151302|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151424|NCT01741259|O2|Outcome|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151425|NCT01741259|O1|Outcome|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
151426|NCT01741259|O2|Outcome|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151427|NCT01741259|O1|Outcome|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
159245|NCT01713621|O2|Outcome|OZ439 500mg|Single dose of 500mg of OZ439 administered as an oral suspension
151303|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151304|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151305|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151306|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151307|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151308|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151309|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151310|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151428|NCT01741259|O2|Outcome|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151429|NCT01741259|O1|Outcome|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
151430|NCT01741259|O2|Outcome|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151431|NCT01741259|O1|Outcome|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
159246|NCT01713621|O1|Outcome|OZ439 100mg|Single dose of 100mg of OZ439 administered as an oral suspension
151311|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151312|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151313|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151314|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151315|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151316|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151317|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151318|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151432|NCT01741259|O2|Outcome|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151433|NCT01741259|O1|Outcome|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
151434|NCT01741259|O2|Outcome|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151435|NCT01741259|O1|Outcome|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
162007|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
151319|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151320|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151321|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151322|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151323|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151324|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151325|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151326|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151436|NCT01741259|O2|Outcome|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151437|NCT01741259|O1|Outcome|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
151438|NCT01741259|O2|Outcome|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151439|NCT01741259|O1|Outcome|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
162008|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
151327|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151328|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151329|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151330|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151331|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151332|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151333|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151334|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151440|NCT01741259|O2|Outcome|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151441|NCT01741259|O1|Outcome|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
151442|NCT01741259|O2|Outcome|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151443|NCT01741259|O1|Outcome|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
162009|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
151335|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151336|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151337|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151338|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151339|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151340|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151341|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151342|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151444|NCT01741259|O2|Outcome|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151445|NCT01741259|O1|Outcome|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
151446|NCT01741259|O2|Outcome|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151447|NCT01741259|O1|Outcome|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
162010|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
151343|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151344|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151345|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151346|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151347|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151348|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151349|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151350|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151448|NCT01741259|O2|Outcome|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151449|NCT01741259|O1|Outcome|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
151450|NCT01741259|O2|Outcome|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151451|NCT01741259|O1|Outcome|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
162011|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
151351|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151352|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151353|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151354|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151355|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151356|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151357|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151358|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151452|NCT01741259|O2|Outcome|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151453|NCT01741259|O1|Outcome|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
151454|NCT01741259|O2|Outcome|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151455|NCT01741259|O1|Outcome|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
162012|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
151359|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151360|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151361|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151362|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151363|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151364|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151365|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151366|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151456|NCT01741259|O2|Outcome|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151457|NCT01741259|O1|Outcome|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
151458|NCT01741259|O2|Outcome|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151459|NCT01741259|O1|Outcome|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
162013|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
151367|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151368|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151369|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151370|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151371|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151372|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151373|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151374|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151460|NCT01741259|E2|Reported Event|Meperidine PCEA With Basal|"Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg~Meperidine"
151461|NCT01741259|E1|Reported Event|Meperidine PCEA|"Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.~Meperidine"
151462|NCT01740817|B1|Baseline|All Study Participants|Participants who were randomized to receive either lipid or saline
151463|NCT01740817|P2|Participant Flow|Saline Then Lipid|Saline infusion 30 ml/h for 48 h, then lipid 30 ml/h for 48 h
151464|NCT01740817|P1|Participant Flow|Lipid Then Saline|Intralipid 20% 30 ml/h for 48 h, then saline 30 ml/h for 48 h
151375|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151376|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151377|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151378|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151379|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151380|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151381|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151382|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151465|NCT01740817|O2|Outcome|Intralipid|liposyn infusion at 30 ml/h for 48 hrs
151466|NCT01740817|O1|Outcome|Saline|Saline infusion at 30 ml/h for 48 h
151467|NCT01740817|O2|Outcome|Intralipid|liposyn infusion at 30 ml/h for 48 hrs
151468|NCT01740817|O1|Outcome|Saline|Saline infusion at 30 ml/h for 48 h
151469|NCT01740817|O2|Outcome|Intralipid|liposyn infusion at 30 ml/h for 48 hrs
151470|NCT01740817|O1|Outcome|Saline|Saline infusion at 30 ml/h for 48 h
151471|NCT01740817|E2|Reported Event|Intralipid|Saline infusion 20%, at 30 ml/h for 48 h, then washout 4-6 weeks, then Intralipid 30 ml/h for 48 h
151383|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151384|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151385|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151386|NCT01741350|E2|Reported Event|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition: Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
151387|NCT01741350|E1|Reported Event|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program: Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
151388|NCT01741272|B3|Baseline|Total|Total of all reporting groups
151389|NCT01741272|B2|Baseline|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
151390|NCT01741272|B1|Baseline|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
151391|NCT01741272|P2|Participant Flow|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
151392|NCT01741272|P1|Participant Flow|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
151393|NCT01741272|O2|Outcome|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
151394|NCT01741272|O1|Outcome|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
151395|NCT01741272|O2|Outcome|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
151396|NCT01741272|O1|Outcome|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
151397|NCT01741272|O2|Outcome|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
151398|NCT01741272|O1|Outcome|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
151399|NCT01741272|O2|Outcome|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
151400|NCT01741272|O1|Outcome|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
162014|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
151474|NCT01740726|B2|Baseline|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
151475|NCT01740726|B1|Baseline|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
151476|NCT01740726|P2|Participant Flow|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
151477|NCT01740726|P1|Participant Flow|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
151478|NCT01740726|O2|Outcome|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
151479|NCT01740726|O1|Outcome|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
151480|NCT01740726|O2|Outcome|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
151481|NCT01740726|O1|Outcome|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
151482|NCT01740726|O2|Outcome|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
151483|NCT01740726|O1|Outcome|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
151484|NCT01740726|O2|Outcome|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
151485|NCT01740726|O1|Outcome|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
151486|NCT01740726|O2|Outcome|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
151487|NCT01740726|O1|Outcome|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
151488|NCT01740726|O2|Outcome|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
151489|NCT01740726|O1|Outcome|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
151490|NCT01740726|O2|Outcome|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
151491|NCT01740726|O1|Outcome|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
151492|NCT01740726|O2|Outcome|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
151530|NCT01740440|O1|Outcome|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks~BMR Face: BMR Face used in accordance with manufacturer IFU"
151531|NCT01740440|O1|Outcome|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks~BMR Face"
151493|NCT01740726|O1|Outcome|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
151494|NCT01740726|O2|Outcome|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
151495|NCT01740726|O1|Outcome|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
151496|NCT01740726|E2|Reported Event|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
151497|NCT01740726|E1|Reported Event|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
151498|NCT01740713|B4|Baseline|Total|Total of all reporting groups
151499|NCT01740713|B3|Baseline|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
151500|NCT01740713|B2|Baseline|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
151501|NCT01740713|B1|Baseline|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
151502|NCT01740713|P3|Participant Flow|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
151503|NCT01740713|P2|Participant Flow|Deferiprone 50 mg/kg/da|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
151504|NCT01740713|P1|Participant Flow|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
151505|NCT01740713|O1|Outcome|Safety Population|patients who may experience adverse events occurred before or after treatment
151506|NCT01740713|O3|Outcome|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
151507|NCT01740713|O2|Outcome|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
151508|NCT01740713|O1|Outcome|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
151509|NCT01740713|O3|Outcome|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
151510|NCT01740713|O2|Outcome|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
151511|NCT01740713|O1|Outcome|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
151512|NCT01740713|O3|Outcome|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
151513|NCT01740713|O2|Outcome|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
151514|NCT01740713|O1|Outcome|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
151515|NCT01740713|O1|Outcome|PK Population|Deferiprone liquid oral solution (80 mg/ml) has been administered at 25/50/100 mg/kg/day
151516|NCT01740713|O3|Outcome|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
151517|NCT01740713|O2|Outcome|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
151518|NCT01740713|O1|Outcome|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
151519|NCT01740713|O1|Outcome|PK Population|Deferiprone liquid oral solution (80 mg/ml) has been administered at 25/50/100 mg/kg/day
151520|NCT01740713|O3|Outcome|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
151521|NCT01740713|O2|Outcome|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
151522|NCT01740713|O1|Outcome|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
151523|NCT01740713|O1|Outcome|PK Population|Deferiprone liquid oral solution (80 mg/ml) has been administered at 25/50/100 mg/kg/day
151524|NCT01740713|E3|Reported Event|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
151525|NCT01740713|E2|Reported Event|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
151526|NCT01740713|E1|Reported Event|Deferiprone 25mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
151527|NCT01740440|B1|Baseline|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks~BMR Face"
151528|NCT01740440|P1|Participant Flow|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks~BMR Face"
151529|NCT01740440|O1|Outcome|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks~BMR Face"
151534|NCT01740427|B2|Baseline|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151535|NCT01740427|B1|Baseline|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151536|NCT01740427|P2|Participant Flow|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151537|NCT01740427|P1|Participant Flow|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151538|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151539|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151540|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151541|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151542|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151543|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151544|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151545|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151546|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151547|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151548|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151549|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151550|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151551|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151552|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151553|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151554|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151555|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151556|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151557|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151558|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151559|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151560|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151561|NCT01740427|E2|Reported Event|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151562|NCT01740427|E1|Reported Event|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
151563|NCT01740414|B3|Baseline|Total|Total of all reporting groups
151564|NCT01740414|B2|Baseline|Placebo|Patient began maintenance on placebo medication prior to maintenance active medication (MN-166, formerly AV411). The subjective and analgesic effects of Oxycodone (0 mg, 15 mg and 30 mg) were tested under each of the two maintenance conditions (Placebo, then MN-166). Data are only from participants who completed both phases of the study.
151615|NCT01740362|B4|Baseline|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
151929|NCT01738971|P2|Participant Flow|Rapid Access|"rapid access to family planning service~rapid access to contraceptive service"
151565|NCT01740414|B1|Baseline|MN-166 (Formerly AV411)|Patient began maintenance on active medication first (MN-166, formerly AV411) prior to maintenance on placebo. The subjective and analgesic effects of Oxycodone (0 mg, 15 mg and 30 mg) were tested under each of the two maintenance conditions (MN-166, then placebo). Data are only from participants who completed both phases of the study.
151566|NCT01740414|P2|Participant Flow|Placebo First|Patient began maintenance on placebo medication prior to switching to the active medication condition(MN-166). The subjective and analgesic effects of Oxycodone (0 mg, 15 mg and 30 mg) were tested under each of the two maintenance conditions (Placebo then MN-166).
151567|NCT01740414|P1|Participant Flow|MN-166 First|Patient began maintenance on active medication first (MN-166, formerly AV411) prior to maintenance on placebo.The subjective and analgesic effects of Oxycodone (0 mg, 15 mg and 30 mg) were tested under each of the two maintenance conditions (MN-166, then Placebo).
151568|NCT01740414|O6|Outcome|Placebo + Oxy 30 mg|The Effects of 30 mg of oxycodone while under placebo maintenance.
151569|NCT01740414|O5|Outcome|Placebo + Oxy 15 mg|The Effects of 15 mg of oxycodone while under placebo maintenance.
151570|NCT01740414|O4|Outcome|Placebo Oxy 0 mg|The Effects of 0 mg of oxycodone while under placebo maintenance.
151571|NCT01740414|O3|Outcome|MN-166 + Oxy 30 mg|The Effects of 30 mg of oxycodone while under MN-166 maintenance.
151572|NCT01740414|O2|Outcome|MN-166 + Oxy 15 mg|The Effects of 15 mg of oxycodone while under MN-166 maintenance.
151573|NCT01740414|O1|Outcome|MN-166 + Oxy 0 mg|The Effects of 0 mg of oxycodone while under MN-166 maintenance.
151574|NCT01740414|O6|Outcome|Placebo + Oxy 30 mg|The Effects of 30 mg of oxycodone while under placebo maintenance.
151575|NCT01740414|O5|Outcome|Placebo + Oxy 15 mg|The Effects of 15 mg of oxycodone while under placebo maintenance.
151576|NCT01740414|O4|Outcome|Placebo + Oxy 0 mg|The Effects of 0 mg of oxycodone while under placebo maintenance.
151577|NCT01740414|O3|Outcome|MN-166 + Oxy 30 mg|The Effects of 30 mg of oxycodone while under MN-166 maintenance.
151578|NCT01740414|O2|Outcome|MN-166 + Oxy 15 mg|The Effects of 15 mg of oxycodone while under MN-166 maintenance.
151579|NCT01740414|O1|Outcome|MN-166 + Oxy 0 mg|The Effects of 0 mg of oxycodone while under MN-166 maintenance.
151580|NCT01740414|O6|Outcome|Placebo + Oxy 30 mg|The Effects of 30 mg of oxycodone while under placebo maintenance.
151581|NCT01740414|O5|Outcome|Placebo + Oxy 15 mg|The Effects of 15 mg of oxycodone while under placebo maintenance.
151582|NCT01740414|O4|Outcome|Placebo + Oxy 0 mg|The Effects of 0 mg of oxycodone while under placebo maintenance.
151583|NCT01740414|O3|Outcome|MN-166 + Oxy 30 mg|The Effects of 30 mg of oxycodone while under MN-166 maintenance.
151584|NCT01740414|O2|Outcome|MN-166 + Oxy 15 mg|The Effects of 15 mg of oxycodone while under MN-166 maintenance.
151585|NCT01740414|O1|Outcome|MN-166 + Oxy 0 mg|The Effects of 0 mg of oxycodone while under MN-166 maintenance.
151586|NCT01740414|E2|Reported Event|Placebo|"Patient is receiving placebo first.~placebo: In the placebo arm, the patients receive placebo for 20 days"
151587|NCT01740414|E1|Reported Event|MN-166 (Formerly AV411)|"Patient is receiving study drug (MN-166) first~MN-166 (formerly AV411): in one study arm, 50mg MN-166 BID are administered daily for 20 days"
151588|NCT01740401|B1|Baseline|Cyclophosphamide, Ipilimumab|"Treatment:~Cyclophosphamide 300 mg/m^2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)~Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv~Cyclophosphamide, Ipilimumab: This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimumab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study"
151589|NCT01740401|P1|Participant Flow|Cyclophosphamide, Ipilimumab|"Treatment:~Cyclophosphamide 300 mg/m^2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)~Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv~Cyclophosphamide, Ipilimumab: This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimumab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study"
151590|NCT01740401|O1|Outcome|Cyclophosphamide, Ipilimumab|"Treatment:~Cyclophosphamide 300 mg/m^2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)~Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv~Cyclophosphamide, Ipilimumab: This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimumab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study"
151591|NCT01740401|O1|Outcome|Cyclophosphamide, Ipilimumab|"Treatment:~Cyclophosphamide 300 mg/m^2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)~Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv~Cyclophosphamide, Ipilimumab: This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimumab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study"
151592|NCT01740401|O1|Outcome|Cyclophosphamide, Ipilimumab|"Treatment:~Cyclophosphamide 300 mg/m^2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)~Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv~Cyclophosphamide, Ipilimumab: This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimumab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study"
164960|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
151593|NCT01740401|O1|Outcome|Cyclophosphamide, Ipilimumab|"Treatment:~Cyclophosphamide 300 mg/m^2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)~Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv~Cyclophosphamide, Ipilimumab: This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimumab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study"
151594|NCT01740401|E1|Reported Event|Cyclophosphamide, Ipilimumab|"Treatment:~Cyclophosphamide 300 mg/m^2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)~Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv~Cyclophosphamide, Ipilimumab: This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimuab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study"
151595|NCT01740388|B3|Baseline|Total|Total of all reporting groups
151596|NCT01740388|B2|Baseline|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
151597|NCT01740388|B1|Baseline|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
151598|NCT01740388|P2|Participant Flow|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
151599|NCT01740388|P1|Participant Flow|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
151600|NCT01740388|O2|Outcome|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
151601|NCT01740388|O1|Outcome|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
151602|NCT01740388|O2|Outcome|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
151603|NCT01740388|O1|Outcome|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
151604|NCT01740388|O2|Outcome|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
151605|NCT01740388|O1|Outcome|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
151606|NCT01740388|O2|Outcome|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
151607|NCT01740388|O1|Outcome|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
151608|NCT01740388|O2|Outcome|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
151609|NCT01740388|O1|Outcome|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
151610|NCT01740388|O2|Outcome|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
151611|NCT01740388|O1|Outcome|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
151612|NCT01740388|E2|Reported Event|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
151613|NCT01740388|E1|Reported Event|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
151614|NCT01740362|B5|Baseline|Total|Total of all reporting groups
151616|NCT01740362|B3|Baseline|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
151617|NCT01740362|B2|Baseline|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
151618|NCT01740362|B1|Baseline|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
151619|NCT01740362|P4|Participant Flow|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
151620|NCT01740362|P3|Participant Flow|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
151621|NCT01740362|P2|Participant Flow|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
151622|NCT01740362|P1|Participant Flow|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
151623|NCT01740362|O4|Outcome|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
151624|NCT01740362|O3|Outcome|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
151625|NCT01740362|O2|Outcome|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
151626|NCT01740362|O1|Outcome|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
151627|NCT01740362|O4|Outcome|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
151628|NCT01740362|O3|Outcome|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
151629|NCT01740362|O2|Outcome|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
151630|NCT01740362|O1|Outcome|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
151631|NCT01740362|O4|Outcome|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
151632|NCT01740362|O3|Outcome|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
151633|NCT01740362|O2|Outcome|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
151634|NCT01740362|O1|Outcome|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
151635|NCT01740362|O4|Outcome|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
151636|NCT01740362|O3|Outcome|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
151637|NCT01740362|O2|Outcome|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
151638|NCT01740362|O1|Outcome|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
151639|NCT01740362|O4|Outcome|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
151640|NCT01740362|O3|Outcome|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
151641|NCT01740362|O2|Outcome|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
151642|NCT01740362|O1|Outcome|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
151643|NCT01740362|E4|Reported Event|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
151644|NCT01740362|E3|Reported Event|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
151645|NCT01740362|E2|Reported Event|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
151646|NCT01740362|E1|Reported Event|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
151647|NCT01740297|B4|Baseline|Total|Total of all reporting groups
151648|NCT01740297|B3|Baseline|Phase 2: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ PFU/mL injected into 1 or more skin, nodal, or subcutaneous tumors with a maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until CR, all injectable tumors had disappeared, confirmed disease progression per the modified irRC, or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
151649|NCT01740297|B2|Baseline|Phase 2: Ipilimumab|Participants received ipilimumab 3 mg/kg intravenously every 3 weeks for a total of 4 infusions starting at week 1.
151650|NCT01740297|B1|Baseline|Phase 1b: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque-forming units (PFU)/mL injected into 1 or more skin, nodal, or subcutaneous tumors with maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until complete response (CR), all injectable tumors had disappeared, confirmed disease progression per the modified immune-related response criteria (irRC), or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab administered intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
151651|NCT01740297|P3|Participant Flow|Phase 2: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ PFU/mL injected into 1 or more skin, nodal, or subcutaneous tumors with a maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until CR, all injectable tumors had disappeared, confirmed disease progression per the modified irRC, or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
151652|NCT01740297|P2|Participant Flow|Phase 2: Ipilimumab|Participants received ipilimumab 3 mg/kg intravenously every 3 weeks for a total of 4 infusions starting at week 1.
151653|NCT01740297|P1|Participant Flow|Phase 1b: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque-forming units (PFU)/mL injected into 1 or more skin, nodal, or subcutaneous tumors with maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until complete response (CR), all injectable tumors had disappeared, confirmed disease progression per the modified immune-related response criteria (irRC), or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab administered intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
151654|NCT01740297|O3|Outcome|Phase 2: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ PFU/mL injected into 1 or more skin, nodal, or subcutaneous tumors with a maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until CR, all injectable tumors had disappeared, confirmed disease progression per the modified irRC, or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
151655|NCT01740297|O2|Outcome|Phase 2: Ipilimumab|Participants received ipilimumab 3 mg/kg intravenously every 3 weeks for a total of 4 infusions starting at week 1.
151656|NCT01740297|O1|Outcome|Phase 1b: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque-forming units (PFU)/mL injected into 1 or more skin, nodal, or subcutaneous tumors with maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until complete response (CR), all injectable tumors had disappeared, confirmed disease progression per the modified immune-related response criteria (irRC), or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab administered intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
151657|NCT01740297|O2|Outcome|Phase 2: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ PFU/mL injected into 1 or more skin, nodal, or subcutaneous tumors with a maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until CR, all injectable tumors had disappeared, confirmed disease progression per the modified irRC, or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
151658|NCT01740297|O1|Outcome|Phase 2: Ipilimumab|Participants received ipilimumab 3 mg/kg intravenously every 3 weeks for a total of 4 infusions starting at week 1.
151659|NCT01740297|O2|Outcome|Phase 2: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ PFU/mL injected into 1 or more skin, nodal, or subcutaneous tumors with a maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until CR, all injectable tumors had disappeared, confirmed disease progression per the modified irRC, or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
151930|NCT01738971|P1|Participant Flow|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
151660|NCT01740297|O1|Outcome|Phase 2: Ipilimumab|Participants received ipilimumab 3 mg/kg intravenously every 3 weeks for a total of 4 infusions starting at week 1.
151661|NCT01740297|O2|Outcome|Phase 2: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ PFU/mL injected into 1 or more skin, nodal, or subcutaneous tumors with a maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until CR, all injectable tumors had disappeared, confirmed disease progression per the modified irRC, or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
151662|NCT01740297|O1|Outcome|Phase 2: Ipilimumab|Participants received ipilimumab 3 mg/kg intravenously every 3 weeks for a total of 4 infusions starting at week 1.
151663|NCT01740297|O2|Outcome|Phase 2: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ PFU/mL injected into 1 or more skin, nodal, or subcutaneous tumors with a maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until CR, all injectable tumors had disappeared, confirmed disease progression per the modified irRC, or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
151664|NCT01740297|O1|Outcome|Phase 2: Ipilimumab|Participants received ipilimumab 3 mg/kg intravenously every 3 weeks for a total of 4 infusions starting at week 1.
151665|NCT01740297|O2|Outcome|Phase 2: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ PFU/mL injected into 1 or more skin, nodal, or subcutaneous tumors with a maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until CR, all injectable tumors had disappeared, confirmed disease progression per the modified irRC, or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
151666|NCT01740297|O1|Outcome|Phase 2: Ipilimumab|Participants received ipilimumab 3 mg/kg intravenously every 3 weeks for a total of 4 infusions starting at week 1.
151667|NCT01740297|O2|Outcome|Phase 2: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ PFU/mL injected into 1 or more skin, nodal, or subcutaneous tumors with a maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until CR, all injectable tumors had disappeared, confirmed disease progression per the modified irRC, or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
151668|NCT01740297|O1|Outcome|Phase 2: Ipilimumab|Participants received ipilimumab 3 mg/kg intravenously every 3 weeks for a total of 4 infusions starting at week 1.
151669|NCT01740297|O2|Outcome|Phase 2: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ PFU/mL injected into 1 or more skin, nodal, or subcutaneous tumors with a maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until CR, all injectable tumors had disappeared, confirmed disease progression per the modified irRC, or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
151670|NCT01740297|O1|Outcome|Phase 2: Ipilimumab|Participants received ipilimumab 3 mg/kg intravenously every 3 weeks for a total of 4 infusions starting at week 1.
151671|NCT01740297|O2|Outcome|Phase 2: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ PFU/mL injected into 1 or more skin, nodal, or subcutaneous tumors with a maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until CR, all injectable tumors had disappeared, confirmed disease progression per the modified irRC, or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
151672|NCT01740297|O1|Outcome|Phase 2: Ipilimumab|Participants received ipilimumab 3 mg/kg intravenously every 3 weeks for a total of 4 infusions starting at week 1.
151673|NCT01740297|O2|Outcome|Phase 2: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ PFU/mL injected into 1 or more skin, nodal, or subcutaneous tumors with a maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until CR, all injectable tumors had disappeared, confirmed disease progression per the modified irRC, or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
151674|NCT01740297|O1|Outcome|Phase 2: Ipilimumab|Participants received ipilimumab 3 mg/kg intravenously every 3 weeks for a total of 4 infusions starting at week 1.
151675|NCT01740297|O1|Outcome|Phase 1b: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque-forming units (PFU)/mL injected into 1 or more skin, nodal, or subcutaneous tumors with maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until complete response (CR), all injectable tumors had disappeared, confirmed disease progression per the modified immune-related response criteria (irRC), or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab administered intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
151789|NCT01739361|P2|Participant Flow|Placebo|"Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.~placebo"
151676|NCT01740297|O2|Outcome|Phase 2: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ PFU/mL injected into 1 or more skin, nodal, or subcutaneous tumors with a maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until CR, all injectable tumors had disappeared, confirmed disease progression per the modified irRC, or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
151677|NCT01740297|O1|Outcome|Phase 2: Ipilimumab|Participants received ipilimumab 3 mg/kg intravenously every 3 weeks for a total of 4 infusions starting at week 1.
151678|NCT01740297|O1|Outcome|Phase 1b: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque-forming units (PFU)/mL injected into 1 or more skin, nodal, or subcutaneous tumors with maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until complete response (CR), all injectable tumors had disappeared, confirmed disease progression per the modified immune-related response criteria (irRC), or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab administered intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
151679|NCT01740297|E3|Reported Event|Phase 2: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ PFU/mL injected into 1 or more skin, nodal, or subcutaneous tumors with a maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until CR, all injectable tumors had disappeared, confirmed disease progression per the modified irRC, or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
151680|NCT01740297|E2|Reported Event|Phase 2: Ipilimumab|Participants received ipilimumab 3 mg/kg intravenously every 3 weeks for a total of 4 infusions starting at week 1.
151681|NCT01740297|E1|Reported Event|Phase 1b: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque-forming units (PFU)/mL injected into 1 or more skin, nodal, or subcutaneous tumors with maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until complete response (CR), all injectable tumors had disappeared, confirmed disease progression per the modified immune-related response criteria (irRC), or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab administered intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
151682|NCT01740206|B3|Baseline|Total|Total of all reporting groups
151683|NCT01740206|B2|Baseline|Patients Not Taking ADHD Medication|Patients who held their stimulant medication the day of surgery.
151684|NCT01740206|B1|Baseline|Patients Taking ADHD Medication|Patients who took their amphetamine and/or methylphenidate the morning of surgery.
151685|NCT01740206|P2|Participant Flow|Patients Not Taking ADHD Medication|Patients who held their stimulant medication the day of surgery.
151686|NCT01740206|P1|Participant Flow|Patients Taking ADHD Medication|Patients who took their amphetamine and/or methylphenidate the morning of surgery.
151687|NCT01740206|O2|Outcome|Patients Not Taking ADHD Medication|Patients who held their stimulant medication the day of surgery.
151688|NCT01740206|O1|Outcome|Patients Taking ADHD Medication|Patients who took their amphetamine and/or methylphenidate the morning of surgery.
151689|NCT01740206|O2|Outcome|Patients Not Taking ADHD Medication|Patients who held their stimulant medication the day of surgery.
151690|NCT01740206|O1|Outcome|Patients Taking ADHD Medication|Patients who took their amphetamine and/or methylphenidate the morning of surgery.
151691|NCT01740206|O2|Outcome|Patients Not Taking ADHD Medication|Patients who held their stimulant medication the day of surgery.
151692|NCT01740206|O1|Outcome|Patients Taking ADHD Medication|Patients who took their amphetamine and/or methylphenidate the morning of surgery.
151693|NCT01740206|O2|Outcome|Patients Not Taking ADHD Medication|Patients who held their stimulant medication the day of surgery.
151694|NCT01740206|O1|Outcome|Patients Taking ADHD Medication|Patients who took their amphetamine and/or methylphenidate the morning of surgery.
151695|NCT01740206|O2|Outcome|Patients Not Taking ADHD Medication|Patients who held their stimulant medication the day of surgery.
151696|NCT01740206|O1|Outcome|Patients Taking ADHD Medication|Patients who took their amphetamine and/or methylphenidate the morning of surgery.
151697|NCT01740206|O2|Outcome|Patients Not Taking ADHD Medication|Patients who held their stimulant medication the day of surgery.
151698|NCT01740206|O1|Outcome|Patients Taking ADHD Medication|Patients who took their amphetamine and/or methylphenidate the morning of surgery.
151699|NCT01740206|E2|Reported Event|Patients Not Taking ADHD Medication|Patients who held their stimulant medication the day of surgery.
151700|NCT01740206|E1|Reported Event|Patients Taking ADHD Medication|Patients who took their amphetamine and/or methylphenidate the morning of surgery.
151701|NCT01740128|B3|Baseline|Total|Total of all reporting groups
151702|NCT01740128|B2|Baseline|Treadmill Then Multimodal Training|"Robotic body weight supported treadmill training will be applied using the Lokomat apparatus. Following a washout period of at least 6 weeks, Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.~Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.~Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151725|NCT01740128|O1|Outcome|Multimodal Training|"Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.~Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151790|NCT01739361|P1|Participant Flow|Acetaminophen|"Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.~Acetaminophen"
151703|NCT01740128|B1|Baseline|Multimodal Then Treadmill Training|"Participants will undergo harness-supported multimodal balance training exercises while simultaneously performing skilled hand exercises. Following a washout period of at least 6 weeks, Participants will undergo body weight supported treadmill training using the Lokomat apparatus.~Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.~Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151704|NCT01740128|P2|Participant Flow|Treadmill Then Multimodal Training|"Participants will undergo body weight supported treadmill training using the Lokomat apparatus. Following a washout period of at least 6 weeks, Participants will undergo harness-supported multimodal balance training exercises while simultaneously performing skilled hand exercises.~Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151705|NCT01740128|P1|Participant Flow|Multimodal Then Treadmill Training|"Participants will undergo harness-supported multimodal balance training exercises while simultaneously performing skilled hand exercises. Following a washout period of at least 6 weeks, Participants will undergo body weight supported treadmill training using the Lokomat apparatus.~Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151706|NCT01740128|O2|Outcome|Treadmill Training|"Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.~Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151707|NCT01740128|O1|Outcome|Multimodal Training|"Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.~Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151708|NCT01740128|O2|Outcome|Treadmill Training|"Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.~Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151709|NCT01740128|O1|Outcome|Multimodal Training|"Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.~Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151710|NCT01740128|O2|Outcome|Treadmill Training|"Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.~Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151711|NCT01740128|O1|Outcome|Multimodal Training|"Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.~Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151712|NCT01740128|O2|Outcome|Treadmill Training|"Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.~Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151713|NCT01740128|O1|Outcome|Multimodal Training|"Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.~Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151714|NCT01740128|O2|Outcome|Treadmill Training|"Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.~Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151715|NCT01740128|O1|Outcome|Multimodal Training|"Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.~Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151716|NCT01740128|O2|Outcome|Treadmill Training|"Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.~Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151717|NCT01740128|O1|Outcome|Multimodal Training|"Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.~Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151718|NCT01740128|O2|Outcome|Treadmill Training|"Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.~Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151719|NCT01740128|O1|Outcome|Multimodal Training|"Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.~Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151720|NCT01740128|O2|Outcome|Treadmill Training|"Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.~Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151721|NCT01740128|O1|Outcome|Multimodal Training|"Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.~Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151722|NCT01740128|O2|Outcome|Treadmill Training|"Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.~Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151723|NCT01740128|O1|Outcome|Multimodal Training|"Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.~Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151724|NCT01740128|O2|Outcome|Treadmill Training|"Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.~Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151884|NCT01739335|O1|Outcome|Mifepristone (600 mg/Day)|600 mg/day mifepristone for one week
151726|NCT01740128|O2|Outcome|Treadmill Training|"Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.~Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151727|NCT01740128|O1|Outcome|Multimodal Training|"Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.~Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151728|NCT01740128|E2|Reported Event|Treadmill Training|"Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.~Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151729|NCT01740128|E1|Reported Event|Multimodal Training|"Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.~Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks."
151730|NCT01740089|B4|Baseline|Total|Total of all reporting groups
151731|NCT01740089|B3|Baseline|PegIntron|"PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin"
151732|NCT01740089|B2|Baseline|Algeron 2.0 μg/kg|"Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
151733|NCT01740089|B1|Baseline|Algeron 1.5 μg/kg|"Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
151734|NCT01740089|P3|Participant Flow|PegIntron|"PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin"
151735|NCT01740089|P2|Participant Flow|Algeron 2.0 μg/kg|"Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
151736|NCT01740089|P1|Participant Flow|Algeron 1.5 μg/kg|"Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
151737|NCT01740089|O2|Outcome|PegIntron (n=50)|
151738|NCT01740089|O1|Outcome|Algeron (n=100)|the comparative inter-group analysis of efficacy was performed for patients of groups 1 and 2 received Algeron (n=100), because after 12 weeks of therapy and analysis of data, all patients of the first and second groups continued receive Algeron in a chosen therapeutic dose 1.5 µg/kg.
151739|NCT01740089|O2|Outcome|PegIntron (n=50)|
151740|NCT01740089|O1|Outcome|Algeron (n=100)|the comparative inter-group analysis of efficacy was performed for patients of groups 1 and 2 received Algeron (n=100), because after 12 weeks of therapy and analysis of data, all patients of the first and second groups continued receive Algeron in a chosen therapeutic dose 1.5 µg/kg.
151741|NCT01740089|O2|Outcome|PegIntron (n=50)|
151742|NCT01740089|O1|Outcome|Algeron (n=100)|the comparative inter-group analysis of efficacy was performed for patients of groups 1 and 2 received Algeron (n=100), because after 12 weeks of therapy and analysis of data, all patients of the first and second groups continued receive Algeron in a chosen therapeutic dose 1.5 µg/kg.
151743|NCT01740089|O3|Outcome|PegIntron|"PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin"
151744|NCT01740089|O2|Outcome|Algeron 2.0 μg/kg|"Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
151745|NCT01740089|O1|Outcome|Algeron 1.5 μg/kg|"Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
151746|NCT01740089|O3|Outcome|PegIntron|"PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin"
151747|NCT01740089|O2|Outcome|Algeron 2.0 μg/kg|"Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
151748|NCT01740089|O1|Outcome|Algeron 1.5 μg/kg|"Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
151749|NCT01740089|E2|Reported Event|PegIntron (n=50)|
151750|NCT01740089|E1|Reported Event|Algeron (n=101)|The safety analysis included 101 patients received at least 1 dose of Algeron (taking into account one patient withdrawn at early stages of the study due to a protocol violation [severe depression by the Beck's scale before the first injection], who was withdrawn from the mITT-analysis)
151751|NCT01739803|B3|Baseline|Total|Total of all reporting groups
151752|NCT01739803|B2|Baseline|Control Group|No intervention
151753|NCT01739803|B1|Baseline|Intervention Group|Behavioral contract intervention
151754|NCT01739803|P2|Participant Flow|Control Group|"No intervention.~The control group received standard specialty pharmacy care, which included mail or telephone reminders of monthly medication refills and an adherence packet consisting of adherence-focused educational pamphlets and a pillbox"
151755|NCT01739803|P1|Participant Flow|Intervention Group|"Behavioral contract intervention.~Each participant in the intervention group met with the study pharmacist to negotiate and sign an immunosuppressant therapy (IST) adherence contract at baseline. Each intervention participant met with the study pharmacist at 3-, 6-, and 9-months post-enrollment to review his or her contract, discuss progress toward reaching the contract's goal of achieving the highest possible IST adherence, update terms of the contract if needed, and re-sign the contract for the next three-month period. At the 12-month post-enrollment meeting, the contract was terminated.~The contract included: (a) motivation(s) for achieving adherence; (b) barriers that may interfere with achieving adherence and possible solutions to overcome barriers; (c) social support available such as a significant other who may assist in following the dosing schedule; (d) tools/strategies to follow the dosing schedule; and (e) possible consequences of nonadherence"
151756|NCT01739803|O2|Outcome|Control Group|No intervention
151757|NCT01739803|O1|Outcome|Intervention Group|Behavioral contract intervention
151758|NCT01739803|O2|Outcome|Control Group|No intervention
151759|NCT01739803|O1|Outcome|Intervention Group|Behavioral contract intervention
151760|NCT01739803|O2|Outcome|Control Group|No intervention
151761|NCT01739803|O1|Outcome|Intervention Group|Behavioral contract intervention
151762|NCT01739803|E2|Reported Event|Control Group|No intervention
151763|NCT01739803|E1|Reported Event|Intervention Group|Behavioral contract intervention
151764|NCT01739790|B3|Baseline|Total|Total of all reporting groups
151765|NCT01739790|B2|Baseline|N-Acetylcysteine|"1800 mg twice daily for 8 weeks~N-Acetylcysteine: 1800 mg twice daily for 8 weeks"
151766|NCT01739790|B1|Baseline|Sugar Pill|"Identical placebo pills twice daily for 8 weeks Placebo pills manufactured to mimic appearance of intervention drug n-acetylcysteine and prescribed with identical frequency and duration.~Placebo: Identical placebo manufactured to mimic appearance of intervention drug with identical frequency and duration."
151767|NCT01739790|P2|Participant Flow|N-Acetylcysteine|1800 mg twice daily for 8 weeks
151768|NCT01739790|P1|Participant Flow|Placebo|Identical placebo manufactured to mimic appearance of intervention drug with identical frequency and duration.
151769|NCT01739790|O2|Outcome|N-Acetylcysteine|1800 mg twice daily for 8 weeks
151770|NCT01739790|O1|Outcome|Placebo|Identical placebo manufactured to mimic appearance of intervention drug with identical frequency and duration.
151771|NCT01739790|E2|Reported Event|N-Acetylcysteine|1800 mg twice daily for 8 weeks
151772|NCT01739790|E1|Reported Event|Placebo|Identical placebo manufactured to mimic appearance of intervention drug with identical frequency and duration.
151773|NCT01739595|B4|Baseline|Total|Total of all reporting groups
151774|NCT01739595|B3|Baseline|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
151775|NCT01739595|B2|Baseline|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
151776|NCT01739595|B1|Baseline|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
151777|NCT01739595|P3|Participant Flow|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
151778|NCT01739595|P2|Participant Flow|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
151779|NCT01739595|P1|Participant Flow|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
151780|NCT01739595|O2|Outcome|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
151781|NCT01739595|O1|Outcome|Androxal Subjects Pooled|"Androxal (enclomiphene citrate), 12.5 mg or 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
151782|NCT01739595|O1|Outcome|Androxal Subjects Pooled|"Androxal (enclomiphene citrate), 12.5 mg or 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
151783|NCT01739595|E3|Reported Event|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
151784|NCT01739595|E2|Reported Event|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
151785|NCT01739595|E1|Reported Event|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
151786|NCT01739361|B3|Baseline|Total|Total of all reporting groups
151787|NCT01739361|B2|Baseline|Placebo|"Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.~placebo"
151788|NCT01739361|B1|Baseline|Acetaminophen|"Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.~Acetaminophen"
151885|NCT01739335|O2|Outcome|Sugar Pill|Placebo (sugar pill) for one week
151791|NCT01739361|O2|Outcome|Placebo|"Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.~placebo"
151792|NCT01739361|O1|Outcome|Acetaminophen|"Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.~Acetaminophen"
151793|NCT01739361|O2|Outcome|Placebo|"Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.~placebo"
151794|NCT01739361|O1|Outcome|Acetaminophen|"Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.~Acetaminophen"
151795|NCT01739361|O2|Outcome|Placebo|"Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.~placebo"
151796|NCT01739361|O1|Outcome|Acetaminophen|"Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.~Acetaminophen"
151797|NCT01739361|E2|Reported Event|Placebo|"Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.~placebo"
151798|NCT01739361|E1|Reported Event|Acetaminophen|"Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.~Acetaminophen"
151799|NCT01739348|B5|Baseline|Total|Total of all reporting groups
151800|NCT01739348|B4|Baseline|Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]|[Part I] Placebo once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151801|NCT01739348|B3|Baseline|Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151802|NCT01739348|B2|Baseline|Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151803|NCT01739348|B1|Baseline|Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]|[Part I] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
151804|NCT01739348|P4|Participant Flow|Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]|[Part I] Placebo once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151805|NCT01739348|P3|Participant Flow|Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151806|NCT01739348|P2|Participant Flow|Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151807|NCT01739348|P1|Participant Flow|Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]|[Part I] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
151808|NCT01739348|O4|Outcome|Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]|[Part I] Placebo once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151809|NCT01739348|O3|Outcome|Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151810|NCT01739348|O2|Outcome|Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151811|NCT01739348|O1|Outcome|Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]|[Part I] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
151812|NCT01739348|O4|Outcome|Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]|[Part I] Placebo once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151813|NCT01739348|O3|Outcome|Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151814|NCT01739348|O2|Outcome|Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151815|NCT01739348|O1|Outcome|Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]|[Part I] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
151816|NCT01739348|O4|Outcome|Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]|[Part I] Placebo once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151817|NCT01739348|O3|Outcome|Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151818|NCT01739348|O2|Outcome|Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151819|NCT01739348|O1|Outcome|Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]|[Part I] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
151820|NCT01739348|O4|Outcome|Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]|[Part I] Placebo once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151821|NCT01739348|O3|Outcome|Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151822|NCT01739348|O2|Outcome|Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151823|NCT01739348|O1|Outcome|Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]|[Part I] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
151824|NCT01739348|O4|Outcome|Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]|[Part I] Placebo once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151825|NCT01739348|O3|Outcome|Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151826|NCT01739348|O2|Outcome|Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151827|NCT01739348|O1|Outcome|Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]|[Part I] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
151828|NCT01739348|O4|Outcome|Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]|[Part I] Placebo once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151829|NCT01739348|O3|Outcome|Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151830|NCT01739348|O2|Outcome|Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151831|NCT01739348|O1|Outcome|Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]|[Part I] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
151832|NCT01739348|O4|Outcome|Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]|[Part I] Placebo once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151833|NCT01739348|O3|Outcome|Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151834|NCT01739348|O2|Outcome|Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151835|NCT01739348|O1|Outcome|Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]|[Part I] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
164961|NCT01694108|O2|Outcome|Control Children (no Intervention)|
151836|NCT01739348|O4|Outcome|Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]|[Part I] Placebo once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151837|NCT01739348|O3|Outcome|Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151838|NCT01739348|O2|Outcome|Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151839|NCT01739348|O1|Outcome|Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]|[Part I] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
151840|NCT01739348|O4|Outcome|Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]|[Part I] Placebo once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151841|NCT01739348|O3|Outcome|Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151842|NCT01739348|O2|Outcome|Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151843|NCT01739348|O1|Outcome|Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]|[Part I] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
151844|NCT01739348|O4|Outcome|Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]|[Part I] Placebo once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151845|NCT01739348|O3|Outcome|Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151846|NCT01739348|O2|Outcome|Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151847|NCT01739348|O1|Outcome|Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]|[Part I] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
151848|NCT01739348|O4|Outcome|Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]|[Part I] Placebo once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151849|NCT01739348|O3|Outcome|Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151850|NCT01739348|O2|Outcome|Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151851|NCT01739348|O1|Outcome|Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]|[Part I] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
151852|NCT01739348|O4|Outcome|Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]|[Part I] Placebo once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151853|NCT01739348|O3|Outcome|Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151854|NCT01739348|O2|Outcome|Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151855|NCT01739348|O1|Outcome|Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]|[Part I] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
164962|NCT01694108|O1|Outcome|BCG-vaccine|
151856|NCT01739348|O4|Outcome|Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]|[Part I] Placebo once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151857|NCT01739348|O3|Outcome|Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151858|NCT01739348|O2|Outcome|Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151859|NCT01739348|O1|Outcome|Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]|[Part I] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
151860|NCT01739348|O4|Outcome|Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]|[Part I] Placebo once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151861|NCT01739348|O3|Outcome|Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151862|NCT01739348|O2|Outcome|Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151863|NCT01739348|O1|Outcome|Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]|[Part I] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
151864|NCT01739348|O4|Outcome|Arm D. Placebo [Part I]; Verubecestat 40 mg [Part II]|[Part I] Placebo once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151865|NCT01739348|O3|Outcome|Arm C. Verubecestat 60mg/40mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151866|NCT01739348|O2|Outcome|Arm B. Verubecestat 40 mg [Part I]; 40 mg [Part II]|[Part I] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151867|NCT01739348|O1|Outcome|Arm A. Verubecestat 12 mg [Part I]; 12 mg [Part II]|[Part I] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study). [Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
151868|NCT01739348|E8|Reported Event|Arm D. Verubecestat 40 mg [Part II]|[Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151869|NCT01739348|E7|Reported Event|Arm C. Verubecestat 40 mg [Part II]|[Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151870|NCT01739348|E6|Reported Event|Arm B. Verubecestat 40 mg [Part II]|[Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 40 mg once daily for an additional 260 weeks.
151871|NCT01739348|E5|Reported Event|Arm A. Verubecestat 12 mg [Part II]|[Part II] Participants completing Study Part I and continuing to Study Part II (Extension Study) receive Verubecestat 12 mg once daily for an additional 260 weeks.
151872|NCT01739348|E4|Reported Event|Arm D. Placebo [Part I]|[Part I] Placebo once daily for 78 weeks in Study Part I (Base Study).
151873|NCT01739348|E3|Reported Event|Arm C. Verubecestat 60mg/40mg [Part I]|[Part I] Verubecestat 60 mg once daily until the first IA in Study Part I (Base Study). Following IA, participants in this group were switched to Verubecestat 40 mg once daily, for the remainder of Study Part I (total dosing period: 78 weeks).
151874|NCT01739348|E2|Reported Event|Arm B. Verubecestat 40 mg [Part I]|[Part I] Verubecestat 40 mg once daily for 78 weeks in Study Part I (Base Study).
151875|NCT01739348|E1|Reported Event|Arm A. Verubecestat 12 mg [Part I]|[Part I] Verubecestat 12 mg once daily for 78 weeks in Study Part I (Base Study).
151876|NCT01739335|B3|Baseline|Total|Total of all reporting groups
151877|NCT01739335|B2|Baseline|Sugar Pill|"Placebo (sugar pill) for one week~Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week"
151878|NCT01739335|B1|Baseline|Mifepristone (600 mg/Day)|"600 mg/day mifepristone for one week~Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week"
151879|NCT01739335|P2|Participant Flow|Sugar Pill|"Placebo (sugar pill) for one week~Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week"
151880|NCT01739335|P1|Participant Flow|Mifepristone (600 mg/Day)|"600 mg/day mifepristone for one week~Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week"
151881|NCT01739335|O2|Outcome|Sugar Pill|Placebo (sugar pill) for one week
151882|NCT01739335|O1|Outcome|Mifepristone (600 mg/Day)|600 mg/day mifepristone for one week
151883|NCT01739335|O2|Outcome|Sugar Pill|Placebo (sugar pill) for one week
151902|NCT01739335|O1|Outcome|Mifepristone (600 mg/Day)|600 mg/day mifepristone for one week Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo
151903|NCT01739335|O2|Outcome|Sugar Pill|"Placebo (sugar pill) for one week~Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week"
151904|NCT01739335|O1|Outcome|Mifepristone (600 mg/Day)|"600 mg/day mifepristone for one week~Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week"
151905|NCT01739335|O2|Outcome|Sugar Pill|"Placebo (sugar pill) for one week~Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week"
151906|NCT01739335|O1|Outcome|Mifepristone (600 mg/Day)|"600 mg/day mifepristone for one week~Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week"
151907|NCT01739335|O2|Outcome|Sugar Pill|"Placebo (sugar pill) for one week~Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week"
151908|NCT01739335|O1|Outcome|Mifepristone (600 mg/Day)|"600 mg/day mifepristone for one week~Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week"
151909|NCT01739335|E2|Reported Event|Sugar Pill|"Placebo (sugar pill) for one week~Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week"
151910|NCT01739335|E1|Reported Event|Mifepristone (600 mg/Day)|"600 mg/day mifepristone for one week~Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week"
151911|NCT01738984|B3|Baseline|Total|Total of all reporting groups
151912|NCT01738984|B2|Baseline|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.~Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
151913|NCT01738984|B1|Baseline|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.~MomZing Web Program: Online web platform that is accessed via a television connected to internet"
151914|NCT01738984|P2|Participant Flow|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.~Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
151915|NCT01738984|P1|Participant Flow|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.~MomZing Web Program: Online web platform that is accessed via a television connected to internet"
151916|NCT01738984|O2|Outcome|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.~Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
151917|NCT01738984|O1|Outcome|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.~MomZing Web Program: Online web platform that is accessed via a television connected to internet"
151918|NCT01738984|O2|Outcome|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.~Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
151919|NCT01738984|O1|Outcome|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.~MomZing Web Program: Online web platform that is accessed via a television connected to internet"
151920|NCT01738984|O2|Outcome|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.~Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
151921|NCT01738984|O1|Outcome|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.~MomZing Web Program: Online web platform that is accessed via a television connected to internet"
151922|NCT01738984|E2|Reported Event|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.~Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
151923|NCT01738984|E1|Reported Event|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.~MomZing Web Program: Online web platform that is accessed via a television connected to internet"
151924|NCT01738971|B4|Baseline|Total|Total of all reporting groups
151925|NCT01738971|B3|Baseline|Progestogen Only Pill|"one month progestogen only pill~one month progestogen only pill"
151931|NCT01738971|O3|Outcome|Progestogen Only Pill|"one month progestogen only pill~one month progestogen only pill"
151932|NCT01738971|O2|Outcome|Rapid Access|"rapid access to family planning service~rapid access to contraceptive service"
151933|NCT01738971|O1|Outcome|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
151934|NCT01738971|O3|Outcome|Progestogen Only Pill|"one month progestogen only pill~one month progestogen only pill"
151935|NCT01738971|O2|Outcome|Rapid Access|"rapid access to family planning service~rapid access to contraceptive service"
151936|NCT01738971|O1|Outcome|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
151937|NCT01738971|O3|Outcome|Progestogen Only Pill|"one month progestogen only pill~one month progestogen only pill"
151938|NCT01738971|O2|Outcome|Rapid Access|"rapid access to family planning service~rapid access to contraceptive service"
151939|NCT01738971|O1|Outcome|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
151940|NCT01738971|E3|Reported Event|Progestogen Only Pill|"one month progestogen only pill~one month progestogen only pill"
151941|NCT01738971|E2|Reported Event|Rapid Access|"rapid access to family planning service~rapid access to contraceptive service"
151942|NCT01738971|E1|Reported Event|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
151943|NCT01738919|B3|Baseline|Total|Total of all reporting groups
151944|NCT01738919|B2|Baseline|Non-subluxated - Operation|"Operative treatment with extension block technique~Operative treatment with extension block technique: Surgery with extension block technique. 6 weeks."
151945|NCT01738919|B1|Baseline|Non-subluxated - Splinting|"Conservative treatment with splinting for 6 weeks.~Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used."
151946|NCT01738919|P2|Participant Flow|Non-subluxated - Operation|"Operative treatment with extension block technique~Operative treatment with extension block technique"
151947|NCT01738919|P1|Participant Flow|Non-subluxated - Splinting|"Conservative treatment with splinting for 6 weeks.~Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used."
151948|NCT01738919|O2|Outcome|Non-subluxated - Operation|Operative treatment with extension block technique
151949|NCT01738919|O1|Outcome|Non-subluxated - Splinting|Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.
151950|NCT01738919|O2|Outcome|Non-subluxated - Operation|Operative treatment with extension block technique
151951|NCT01738919|O1|Outcome|Non-subluxated - Splinting|Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.
151952|NCT01738919|O2|Outcome|Non-subluxated - Operation|Operative treatment with extension block technique
151953|NCT01738919|O1|Outcome|Non-subluxated - Splinting|Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.
151954|NCT01738919|O2|Outcome|Non-subluxated - Operation|Operative treatment with extension block technique
151955|NCT01738919|O1|Outcome|Non-subluxated - Splinting|Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.
151956|NCT01738919|O2|Outcome|Non-subluxated - Operation|Operative treatment with extension block technique
151957|NCT01738919|O1|Outcome|Non-subluxated - Splinting|Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.
151958|NCT01738919|O2|Outcome|Non-subluxated - Operation|"Operative treatment with extension block technique~Operative treatment with extension block technique: Surgery with extension block technique. 6 weeks."
151959|NCT01738919|O1|Outcome|Non-subluxated - Splinting|"Conservative treatment with splinting for 6 weeks.~Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used."
151960|NCT01738919|E2|Reported Event|Non-subluxated - Operation|"Operative treatment with extension block technique~Operative treatment with extension block technique"
151961|NCT01738919|E1|Reported Event|Non-subluxated - Splinting|"Conservative treatment with splinting for 6 weeks.~Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used."
151962|NCT01738750|B3|Baseline|Total|Total of all reporting groups
151963|NCT01738750|B2|Baseline|No Cost Information Included|Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure.
151964|NCT01738750|B1|Baseline|Cost Information Included|"Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure.~Cost Information Included"
151965|NCT01738750|P2|Participant Flow|No Cost Information Included|Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure.
151966|NCT01738750|P1|Participant Flow|Cost Information Included|"Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure.~Cost Information Included"
151967|NCT01738750|O2|Outcome|No Dollar Information Included|Group of patients that will not receive dollar information for the laparoscopic and open surgical procedures prior to choice of procedure.
151968|NCT01738750|O1|Outcome|Dollar Information Included|"Group of patients that will receive dollars information for both the laparoscopic and open surgical procedures prior to choice of procedure.~Dollars Information Included"
151969|NCT01738750|O2|Outcome|No Cost Information Included|Percentage of Participants who Choose Open Appendectomy or Laparoscopic Appendectomy
151970|NCT01738750|O1|Outcome|Cost Information Included|Percentage of Participants who Choose Open Appendectomy or Laparoscopic Appendectomy
151971|NCT01738750|E2|Reported Event|No Cost Information Included|Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure.
151972|NCT01738750|E1|Reported Event|Cost Information Included|"Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure.~Cost Information Included"
151973|NCT01738737|B6|Baseline|Total|Total of all reporting groups
151974|NCT01738737|B5|Baseline|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
151975|NCT01738737|B4|Baseline|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
151976|NCT01738737|B3|Baseline|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
151977|NCT01738737|B2|Baseline|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
151978|NCT01738737|B1|Baseline|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
151979|NCT01738737|P5|Participant Flow|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
151980|NCT01738737|P4|Participant Flow|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 9 points of application of active laser per knee (frontal faces, lateral and medial)"
151981|NCT01738737|P3|Participant Flow|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 9 points of application of active laser per knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
151982|NCT01738737|P2|Participant Flow|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 9 points of application of placebo laser per knee (frontal faces, lateral and medial)"
151983|NCT01738737|P1|Participant Flow|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
151984|NCT01738737|O5|Outcome|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
151985|NCT01738737|O4|Outcome|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
151986|NCT01738737|O3|Outcome|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
151987|NCT01738737|O2|Outcome|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
151988|NCT01738737|O1|Outcome|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
151989|NCT01738737|O5|Outcome|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
151990|NCT01738737|O4|Outcome|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
151991|NCT01738737|O3|Outcome|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
151992|NCT01738737|O2|Outcome|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
151993|NCT01738737|O1|Outcome|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
151994|NCT01738737|O5|Outcome|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
151995|NCT01738737|O4|Outcome|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
151996|NCT01738737|O3|Outcome|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
151997|NCT01738737|O2|Outcome|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
151998|NCT01738737|O1|Outcome|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
151999|NCT01738737|O5|Outcome|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
152000|NCT01738737|O4|Outcome|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
152001|NCT01738737|O3|Outcome|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
152002|NCT01738737|O2|Outcome|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
152049|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
164963|NCT01694108|E2|Reported Event|Control Children (no Intervention)|
152003|NCT01738737|O1|Outcome|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
152004|NCT01738737|O5|Outcome|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
152005|NCT01738737|O4|Outcome|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
152006|NCT01738737|O3|Outcome|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
152007|NCT01738737|O2|Outcome|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
152008|NCT01738737|O1|Outcome|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
152009|NCT01738737|E5|Reported Event|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
152010|NCT01738737|E4|Reported Event|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
152011|NCT01738737|E3|Reported Event|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
152012|NCT01738737|E2|Reported Event|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
152013|NCT01738737|E1|Reported Event|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
152014|NCT01738698|B5|Baseline|Total|Total of all reporting groups
152015|NCT01738698|B4|Baseline|Placebo|Placebo: Oral administration once-daily for 12 weeks
152016|NCT01738698|B3|Baseline|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
152017|NCT01738698|B2|Baseline|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
152018|NCT01738698|B1|Baseline|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
152019|NCT01738698|P4|Participant Flow|Placebo|Placebo: Oral administration once-daily for 12 weeks
152020|NCT01738698|P3|Participant Flow|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
152021|NCT01738698|P2|Participant Flow|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
152022|NCT01738698|P1|Participant Flow|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
152023|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
152024|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
152025|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
152026|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
152027|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
152028|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
152029|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
152030|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
152031|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
152032|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
152033|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
152034|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
152035|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
152036|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
152037|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
152038|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
152039|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
152040|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
152041|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
152042|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
152043|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
152044|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
152045|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
152046|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
152047|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
152048|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
152050|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
152051|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
152052|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
152053|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
152054|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
152055|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
152056|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
152057|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
152058|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
152059|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
152060|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
152061|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
152062|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
152063|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
152064|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
152065|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
152066|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
152067|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
152068|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
152069|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
152070|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
152071|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
152072|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
152073|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
152074|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
152075|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
152076|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
152077|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
152078|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
152079|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
152080|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
152081|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
152082|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
152083|NCT01738698|E4|Reported Event|Placebo|Placebo: Oral administration once-daily for 12 weeks
152084|NCT01738698|E3|Reported Event|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
152085|NCT01738698|E2|Reported Event|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
152086|NCT01738698|E1|Reported Event|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
152087|NCT01738672|B1|Baseline|Nitrous Oxide|"Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.~Inhaled nitrous oxide: Administration of nitrous oxide for labor analgesia"
152088|NCT01738672|P1|Participant Flow|Nitrous Oxide|"Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.~Inhaled nitrous oxide: Administration of nitrous oxide for labor analgesia"
152089|NCT01738672|O1|Outcome|Nitrous Oxide|"Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.~Inhaled nitrous oxide: Administration of nitrous oxide for labor analgesia"
152090|NCT01738672|O1|Outcome|Nitrous Oxide|"Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.~Inhaled nitrous oxide: Administration of nitrous oxide for labor analgesia"
152091|NCT01738672|O1|Outcome|Nitrous Oxide|"Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.~Inhaled nitrous oxide: Administration of nitrous oxide for labor analgesia"
152092|NCT01738672|O1|Outcome|Nitrous Oxide|"Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.~Inhaled nitrous oxide: Administration of nitrous oxide for labor analgesia"
152093|NCT01738672|O1|Outcome|Nitrous Oxide|"Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.~Inhaled nitrous oxide: Administration of nitrous oxide for labor analgesia"
152094|NCT01738672|O1|Outcome|Nitrous Oxide|"Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.~Inhaled nitrous oxide: Administration of nitrous oxide for labor analgesia"
152095|NCT01738672|E1|Reported Event|Nitrous Oxide|"Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.~Inhaled nitrous oxide: Administration of nitrous oxide for labor analgesia"
152096|NCT01738646|B1|Baseline|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
152097|NCT01738646|P1|Participant Flow|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
152098|NCT01738646|O1|Outcome|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
152099|NCT01738646|O1|Outcome|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
152100|NCT01738646|O1|Outcome|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
152101|NCT01738646|O1|Outcome|Vorinostat & Bevacizumab|"Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.~Vorinostat~Bevacizumab"
152102|NCT01738646|O1|Outcome|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
152103|NCT01738646|E1|Reported Event|Vorinostat & Bevacizumab|Patients will be evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
152104|NCT01738581|B3|Baseline|Total|Total of all reporting groups
152105|NCT01738581|B2|Baseline|rTMS + CTL, rTMS + Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation (rTMS) with control therapy (CTL). CTL therapy was non-specific therapy that includes stretching, massage, range of motion for the first phase, then rTMS with sensorimotor retraining.~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
152106|NCT01738581|B1|Baseline|rTMS + Sensorimotor Retraining, rTMS + CTL|"Repetitive transcranial magnetic (rTMS) stimulation and sensorimotor retraining for the first phase, then rTMS with control therapy (CTL). CTL therapy was non-specific therapy that includes stretching, massage, range of motion.~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
152107|NCT01738581|P2|Participant Flow|rTMS + CTL, Then rTMS + SMR|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
152108|NCT01738581|P1|Participant Flow|rTMS + SMR, Then rTMS + CTL|"Repetitive transcranial magnetic stimulation and sensorimotor retraining~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
152109|NCT01738581|O2|Outcome|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
152110|NCT01738581|O1|Outcome|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
152111|NCT01738581|O2|Outcome|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
152112|NCT01738581|O1|Outcome|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
152113|NCT01738581|O2|Outcome|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
152114|NCT01738581|O1|Outcome|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
152115|NCT01738581|O2|Outcome|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
152116|NCT01738581|O1|Outcome|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
152117|NCT01738581|O2|Outcome|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
152118|NCT01738581|O1|Outcome|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
152119|NCT01738581|O2|Outcome|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
152120|NCT01738581|O1|Outcome|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
152121|NCT01738581|O2|Outcome|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
152122|NCT01738581|O1|Outcome|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
152123|NCT01738581|E2|Reported Event|rTMS With CTL, Then rTMS With Sensorimotor Retrain|"Repetitive transcranial magnetic stimulation (rTMS) with control (CTL) non-specific therapy that includes stretching, massage, range of motion for first phase, then rTMS with sensorimotor retraining for second phase.~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
152124|NCT01738581|E1|Reported Event|rTMS With Sensorimotor Retraining, Then rTMS With CTL|"Repetitive transcranial magnetic stimulation (rTMS) and sensorimotor retraining for first phase, then rTMS with control (CTL) therapy.~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
152125|NCT01738503|B7|Baseline|Total|Total of all reporting groups
152126|NCT01738503|B6|Baseline|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152127|NCT01738503|B5|Baseline|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152128|NCT01738503|B4|Baseline|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152129|NCT01738503|B3|Baseline|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152130|NCT01738503|B2|Baseline|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152131|NCT01738503|B1|Baseline|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152132|NCT01738503|P7|Participant Flow|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152133|NCT01738503|P6|Participant Flow|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152134|NCT01738503|P5|Participant Flow|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152135|NCT01738503|P4|Participant Flow|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152136|NCT01738503|P3|Participant Flow|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152137|NCT01738503|P2|Participant Flow|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152138|NCT01738503|P1|Participant Flow|SUBUTEX|Participants who entered the Induction/Stabalization period, were treated with SUBUTEX SL. Those who did not complete this period, did not continue into the Treatment period.
152139|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152140|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152141|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152142|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152143|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152144|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152145|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152146|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152147|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152148|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152149|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152150|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152151|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152152|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152153|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152154|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
164964|NCT01694108|E1|Reported Event|BCG-vaccine|
152155|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152156|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152157|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152158|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152159|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152160|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152161|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152162|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152163|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152164|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152165|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152166|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152167|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152168|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152169|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152170|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152171|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152221|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152172|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152173|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152174|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152175|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152176|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152177|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152178|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152179|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152180|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152181|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152182|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152183|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152184|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152185|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152186|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152187|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152222|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152240|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152188|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152189|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152190|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152191|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152192|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152193|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152194|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152195|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152196|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152197|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152198|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152199|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152200|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152201|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152202|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152203|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152204|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152239|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152205|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152206|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152207|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152208|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152209|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152210|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152211|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152212|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152213|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152214|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152215|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152216|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152217|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152218|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152219|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152220|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
164965|NCT01693900|B3|Baseline|Total|Total of all reporting groups
152223|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152224|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152225|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152226|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152227|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152228|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152229|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152230|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152231|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152232|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152233|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152234|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152235|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152236|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152237|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152238|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
166314|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
152241|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152242|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152243|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152244|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152245|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152246|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152247|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152248|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152249|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152250|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152251|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152252|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152253|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152254|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152255|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152256|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
173016|NCT01665170|O1|Outcome|Placebo|Placebo arm
152257|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152258|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152259|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152260|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152261|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152262|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152263|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152264|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152265|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152266|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152267|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152268|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152269|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152270|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152271|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152272|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152273|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152323|NCT01738503|O3|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152274|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152275|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152276|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152277|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152278|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152279|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152280|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152281|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152282|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152283|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152284|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152285|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152286|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152287|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152288|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152289|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152324|NCT01738503|O2|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152325|NCT01738503|O1|Outcome|SUBUTEX Only|Participants who entered the Induction/Stabalization period, were treated with SUBUTEX SL and did not continue into the Treatment period.
152290|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152291|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152292|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152293|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152294|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152295|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152296|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152297|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152298|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152299|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152300|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152301|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152302|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152303|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152304|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152305|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152306|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152408|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
152307|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152308|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152309|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152310|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152311|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152312|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152313|NCT01738503|O6|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152314|NCT01738503|O5|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152315|NCT01738503|O4|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152316|NCT01738503|O3|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152317|NCT01738503|O2|Outcome|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152318|NCT01738503|O1|Outcome|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152319|NCT01738503|O7|Outcome|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152320|NCT01738503|O6|Outcome|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152321|NCT01738503|O5|Outcome|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152322|NCT01738503|O4|Outcome|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
173017|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
152326|NCT01738503|E7|Reported Event|Group 6 (8-24 mg) RBP-6000: 300 mg|"Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.~Participants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152327|NCT01738503|E6|Reported Event|Group 5 (14 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 112 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152328|NCT01738503|E5|Reported Event|Group 4 (8 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.
152329|NCT01738503|E4|Reported Event|Group 3 (24 mg) RBP-6000: 200 mg|"Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.~Participants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection."
152330|NCT01738503|E3|Reported Event|Group 2 (12 mg) RBP-6000: 100 mg|Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals
152331|NCT01738503|E2|Reported Event|Group 1 (8 mg) RBP-6000: 50 mg|Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.
152332|NCT01738503|E1|Reported Event|SUBUTEX Only|Participants who entered the Induction/Stabalization period, were treated with SUBUTEX SL and did not continue into the Treatment period.
152333|NCT01738477|B3|Baseline|Total|Total of all reporting groups
152334|NCT01738477|B2|Baseline|Boostrix Group 2|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
152335|NCT01738477|B1|Baseline|Boostrix Group 1|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
152336|NCT01738477|P2|Participant Flow|Boostrix Group 2|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
152337|NCT01738477|P1|Participant Flow|Boostrix Group 1|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
152338|NCT01738477|O2|Outcome|Boostrix Group 2|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix™ in this study.
152339|NCT01738477|O1|Outcome|Boostrix Group 1|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix™ in this study.
152340|NCT01738477|O2|Outcome|Boostrix Group 2|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix™ in this study.
152341|NCT01738477|O1|Outcome|Boostrix Group 1|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix™ in this study.
152342|NCT01738477|O2|Outcome|Boostrix Group 2|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix™ in this study.
152343|NCT01738477|O1|Outcome|Boostrix Group 1|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix™ in this study.
152344|NCT01738477|O2|Outcome|Boostrix Group 2|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix™ in this study.
152345|NCT01738477|O1|Outcome|Boostrix Group 1|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix™ in this study.
152346|NCT01738477|O2|Outcome|Boostrix Group 2|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
152347|NCT01738477|O1|Outcome|Boostrix Group 1|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
152348|NCT01738477|O2|Outcome|Boostrix Group 2|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
152349|NCT01738477|O1|Outcome|Boostrix Group 1|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
152350|NCT01738477|O2|Outcome|Boostrix Group 2|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
152351|NCT01738477|O1|Outcome|Boostrix Group 1|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
152352|NCT01738477|O2|Outcome|Boostrix Group 2|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
152353|NCT01738477|O1|Outcome|Boostrix Group 1|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
152354|NCT01738477|O2|Outcome|Boostrix Group 2|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
152355|NCT01738477|O1|Outcome|Boostrix Group 1|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
152356|NCT01738477|O2|Outcome|Boostrix Group 2|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
152357|NCT01738477|O1|Outcome|Boostrix Group 1|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
152358|NCT01738477|O2|Outcome|Boostrix Group 2|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
152359|NCT01738477|O1|Outcome|Boostrix Group 1|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
152360|NCT01738477|O2|Outcome|Boostrix Group 2|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
152361|NCT01738477|O1|Outcome|Boostrix Group 1|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
152362|NCT01738477|E2|Reported Event|Boostrix Group 2|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
152363|NCT01738477|E1|Reported Event|Boostrix Group 1|Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
152364|NCT01738438|B1|Baseline|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
152365|NCT01738438|P1|Participant Flow|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
152366|NCT01738438|O1|Outcome|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
152367|NCT01738438|O1|Outcome|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
152368|NCT01738438|O1|Outcome|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
152369|NCT01738438|E1|Reported Event|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
152370|NCT01738321|B3|Baseline|Total|Total of all reporting groups
152371|NCT01738321|B2|Baseline|Non-cardiac Patients|"Patients undergoing any surgery other than cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
152372|NCT01738321|B1|Baseline|Cardiac Patients|"Patients undergoing cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
152373|NCT01738321|P2|Participant Flow|Non-cardiac Patients|"Patients undergoing any surgery other than cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
152374|NCT01738321|P1|Participant Flow|Cardiac Patients|"Patients undergoing cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
152375|NCT01738321|O2|Outcome|Non-cardiac Patients|"Patients undergoing any surgery other than cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
152376|NCT01738321|O1|Outcome|Cardiac Patients|"Patients undergoing cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
152377|NCT01738321|E2|Reported Event|Non-cardiac Patients|"Patients undergoing any surgery other than cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
152378|NCT01738321|E1|Reported Event|Cardiac Patients|"Patients undergoing cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
152379|NCT01737996|B4|Baseline|Total|Total of all reporting groups
173018|NCT01665170|O1|Outcome|Placebo|Placebo arm
152380|NCT01737996|B3|Baseline|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
152381|NCT01737996|B2|Baseline|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
152382|NCT01737996|B1|Baseline|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
152383|NCT01737996|P3|Participant Flow|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
152384|NCT01737996|P2|Participant Flow|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose (MRD) part.
152385|NCT01737996|P1|Participant Flow|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose (MRD) part.
152386|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
152387|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
152388|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
152389|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
152390|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
152391|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
152392|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
152393|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
152394|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
152395|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
152396|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
152397|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
152398|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
152399|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
152400|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
152401|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
152402|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
152403|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
152404|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
152405|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
152406|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
152407|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
152450|NCT01737931|O3|Outcome|No-treatment|No treatment to the application sites after the patch removal
152409|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
152410|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
152411|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
152412|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
152413|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
152414|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
152415|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
152416|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
152417|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
152418|NCT01737996|E3|Reported Event|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
152419|NCT01737996|E2|Reported Event|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
152420|NCT01737996|E1|Reported Event|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
152421|NCT01737944|B5|Baseline|Total|Total of all reporting groups
152422|NCT01737944|B4|Baseline|25mg MTX Group|[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C]
152423|NCT01737944|B3|Baseline|20mg MTX Group|[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C]
152424|NCT01737944|B2|Baseline|15mg MTX Group|[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C]
152425|NCT01737944|B1|Baseline|10mg MTX Group|[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C]
152426|NCT01737944|P4|Participant Flow|25mg MTX Group|[administered via randomized sequence and crossover of Treatment Arm A -SC injection with Vibex MTX device, Treatment Arm B -SC injection without device and Treatment Arm C -IM Injection]
152427|NCT01737944|P3|Participant Flow|20mg MTX Group|[administered via randomized sequence and crossover of Treatment Arm A -SC injection with Vibex MTX device, Treatment Arm B -SC injection without device and Treatment Arm C -IM Injection]
152428|NCT01737944|P2|Participant Flow|15mg MTX Group|[administered via randomized sequence and crossover of Treatment Arm A -SC injection with Vibex MTX device, Treatment Arm B -SC injection without device and Treatment Arm C -IM Injection]
152429|NCT01737944|P1|Participant Flow|10mg MTX Group|[administered via randomized sequence and crossover of Treatment Arm A -SC injection with Vibex MTX device, Treatment Arm B -SC injection without device and Treatment Arm C -IM Injection]
152430|NCT01737944|O3|Outcome|Treatment Arm C|Intramuscular (IM) injection of MTX
152431|NCT01737944|O2|Outcome|Treatment Arm B|SC injection of MTX without the device
152432|NCT01737944|O1|Outcome|Treatment Arm A|Subcutaneous (SC) injection with the Vibex MTX device
152433|NCT01737944|O3|Outcome|Treatment Arm C|Intramuscular (IM) injection of MTX
152434|NCT01737944|O2|Outcome|Treatment Arm B|SC injection of MTX without the device
152435|NCT01737944|O1|Outcome|Treatment Arm A|Subcutaneous (SC) injection with the Vibex MTX device
152436|NCT01737944|O3|Outcome|Treatment Arm C|Intramuscular (IM) injection of MTX
152437|NCT01737944|O2|Outcome|Treatment Arm B|SC injection of MTX without the device
152438|NCT01737944|O1|Outcome|Treatment Arm A|Subcutaneous (SC) injection with the Vibex MTX device
152439|NCT01737944|E4|Reported Event|25mg MTX|[Administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C]
152440|NCT01737944|E3|Reported Event|20mg MTX|[Administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C]
152441|NCT01737944|E2|Reported Event|15mg MTX|[Administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C]
152442|NCT01737944|E1|Reported Event|10mg MTX|[Administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C]
152443|NCT01737931|B4|Baseline|Total|Total of all reporting groups
152444|NCT01737931|B3|Baseline|No-treatment|No treatment to the application sites after the patch removal
152445|NCT01737931|B2|Baseline|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
152446|NCT01737931|B1|Baseline|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
152447|NCT01737931|P3|Participant Flow|No-treatment|No treatment to the application sites after the patch removal
152448|NCT01737931|P2|Participant Flow|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
152449|NCT01737931|P1|Participant Flow|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
152451|NCT01737931|O2|Outcome|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
152452|NCT01737931|O1|Outcome|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
152453|NCT01737931|O3|Outcome|No-treatment|No treatment to the application sites after the patch removal
152454|NCT01737931|O2|Outcome|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
152455|NCT01737931|O1|Outcome|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
152456|NCT01737931|O3|Outcome|No-treatment|No treatment to the application sites after the patch removal
152457|NCT01737931|O2|Outcome|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
152458|NCT01737931|O1|Outcome|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
152459|NCT01737931|O3|Outcome|No-treatment|No treatment to the application sites after the patch removal
152460|NCT01737931|O2|Outcome|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
152461|NCT01737931|O1|Outcome|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
152462|NCT01737931|E1|Reported Event|Over-all|"In this study, all the subjects were received SPM962 with the same dose and regimen during the acceleration and dose-escalation periods and then they were randomized into one of the three groups after removal of SPM962 to evaluate recovery of skin reaction caused by SPM962 using either steroids, antihistamine or no treatment.~Since AEs mainly occurred in the acceleration and dose-escalation periods when SPM962 were used, AEs are shown in one group."
152463|NCT01737879|B1|Baseline|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
152464|NCT01737879|P1|Participant Flow|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
152465|NCT01737879|O1|Outcome|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
152466|NCT01737879|O1|Outcome|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
152467|NCT01737879|O1|Outcome|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
152468|NCT01737879|O1|Outcome|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
152469|NCT01737879|E1|Reported Event|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
152470|NCT01737840|B3|Baseline|Total|Total of all reporting groups
152471|NCT01737840|B2|Baseline|Ranitidine|"Intravenous ranitidine 50 mg~Ranitidine: 33 patients"
152472|NCT01737840|B1|Baseline|Pantoprazole|"Intravenous pantoprazole 40 mg flacon~Pantoprazole: 33 patients"
152473|NCT01737840|P2|Participant Flow|Ranitidine|"Intravenous ranitidine 50 mg~Ranitidine: 33 patients"
152474|NCT01737840|P1|Participant Flow|Pantoprazole|"Intravenous pantoprazole 40 mg flacon~Pantoprazole: 33 patients"
152475|NCT01737840|O2|Outcome|Ranitidine|"Intravenous ranitidine 50 mg~Ranitidine: 33 patients"
152476|NCT01737840|O1|Outcome|Pantoprazole|"Intravenous pantoprazole 40 mg flacon~Pantoprazole: 33 patients"
152477|NCT01737840|O2|Outcome|Ranitidine|Intravenous ranitidine 50 mg
152478|NCT01737840|O1|Outcome|Pantoprazole|Intravenous pantoprazole 40 mg
152479|NCT01737840|E2|Reported Event|Ranitidine|"Intravenous ranitidine 50 mg~Ranitidine: 33 patients"
152480|NCT01737840|E1|Reported Event|Pantoprazole|"Intravenous pantoprazole 40 mg flacon~Pantoprazole: 33 patients"
152481|NCT01737762|B3|Baseline|Total|Total of all reporting groups
152482|NCT01737762|B2|Baseline|Vehicle|Vehicle Control(fibrinogen solution & thrombin solution without cells)
152483|NCT01737762|B1|Baseline|HP802-247|HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 solution) containing 0.5 x 106 cells per mL every 14 days.
152484|NCT01737762|P2|Participant Flow|Vehicle|Vehicle Control(fibrinogen solution & thrombin solution without cells)
152485|NCT01737762|P1|Participant Flow|HP802-247|HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 solution) containing 0.5 x 106 cells per mL every 14 days.
152486|NCT01737762|O2|Outcome|Vehicle|Vehicle Control(fibrinogen solution & thrombin solution without cells)
152487|NCT01737762|O1|Outcome|HP802-247|HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 solution) containing 0.5 x 106 cells per mL every 14 days.
152488|NCT01737762|O2|Outcome|Vehicle|Vehicle Control(fibrinogen solution & thrombin solution without cells)
152489|NCT01737762|O1|Outcome|HP802-247|HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 solution) containing 0.5 x 106 cells per mL every 14 days.
152490|NCT01737762|E2|Reported Event|Vehicle|"Vehicle Control(fibrinogen solution & thrombin solution without cells)~Vehicle"
152491|NCT01737762|E1|Reported Event|HP802-247|HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 solution) containing 0.5 x 106 cells per mL every 14 days.
152492|NCT01737710|B6|Baseline|Total|Total of all reporting groups
152605|NCT01737021|B2|Baseline|Treatment as Usual|There is no existing standard follow up for parents of children discharged from PICU.
152493|NCT01737710|B5|Baseline|Mild AD, Intradermal|Mild atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152494|NCT01737710|B4|Baseline|Non-AD, Intramuscular|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials
152495|NCT01737710|B3|Baseline|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
152496|NCT01737710|B2|Baseline|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152497|NCT01737710|B1|Baseline|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152498|NCT01737710|P5|Participant Flow|Mild AD, Intradermal|Mild atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152499|NCT01737710|P4|Participant Flow|Non-AD, Intramuscular|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials
152500|NCT01737710|P3|Participant Flow|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
152501|NCT01737710|P2|Participant Flow|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152502|NCT01737710|P1|Participant Flow|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152503|NCT01737710|O2|Outcome|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
152504|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152505|NCT01737710|O2|Outcome|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
152506|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152507|NCT01737710|O2|Outcome|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
152508|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152509|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152510|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152511|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152512|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152513|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152514|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152515|NCT01737710|O2|Outcome|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
152516|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152517|NCT01737710|O2|Outcome|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
152518|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152519|NCT01737710|O2|Outcome|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
152520|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152606|NCT01737021|B1|Baseline|Psycho-educational Intervention|Received psycho-educational intervention.
152521|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152522|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152523|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152524|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152525|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152526|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152527|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152528|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152529|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152530|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152531|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152532|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152533|NCT01737710|E5|Reported Event|Mild AD, Intradermal|Mild atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152534|NCT01737710|E4|Reported Event|Non-AD, Intramuscular|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials
152535|NCT01737710|E3|Reported Event|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
152536|NCT01737710|E2|Reported Event|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152537|NCT01737710|E1|Reported Event|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
152538|NCT01737684|B3|Baseline|Total|Total of all reporting groups
152539|NCT01737684|B2|Baseline|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
152540|NCT01737684|B1|Baseline|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
152541|NCT01737684|P3|Participant Flow|Participants With Mild Hepatic Insufficiencey|Participants with mild hepatic insufficiency were to receive a single oral dose of vibegron 100 mg.
152542|NCT01737684|P2|Participant Flow|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
152543|NCT01737684|P1|Participant Flow|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
152544|NCT01737684|O2|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
152545|NCT01737684|O1|Outcome|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
152546|NCT01737684|O2|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
152547|NCT01737684|O1|Outcome|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
152548|NCT01737684|O2|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
152549|NCT01737684|O1|Outcome|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
152550|NCT01737684|O2|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
152551|NCT01737684|O1|Outcome|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
152552|NCT01737684|O2|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
152553|NCT01737684|O1|Outcome|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
152554|NCT01737684|O2|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
152555|NCT01737684|O1|Outcome|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
152556|NCT01737684|E2|Reported Event|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
152557|NCT01737684|E1|Reported Event|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
152558|NCT01737593|B4|Baseline|Total|Total of all reporting groups
152559|NCT01737593|B3|Baseline|Acetaminophen PO-high Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
152560|NCT01737593|B2|Baseline|Acetaminophen PO-low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
152561|NCT01737593|B1|Baseline|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
152562|NCT01737593|P3|Participant Flow|Acetaminophen PO-high Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
152563|NCT01737593|P2|Participant Flow|Acetaminophen PO-low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
152564|NCT01737593|P1|Participant Flow|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
152565|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
152566|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
152567|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
152568|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
152569|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
152570|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
152571|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
152572|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
152573|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
152574|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
152575|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
152576|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
152577|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
152578|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
152579|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
152580|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
152581|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
152582|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
152583|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
152584|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
152585|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
152586|NCT01737593|O3|Outcome|Acetaminophen by Mouth (PO) - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
152587|NCT01737593|O2|Outcome|Acetaminophen by Mouth (PO) - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
152588|NCT01737593|O1|Outcome|Acetaminophen by Rectum (PR)|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
152589|NCT01737593|E3|Reported Event|Acetaminophen PO-high Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
152590|NCT01737593|E2|Reported Event|Acetaminophen PO-low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
152591|NCT01737593|E1|Reported Event|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
152607|NCT01737021|P2|Participant Flow|Treatment as Usual|There is no existing standard follow up for parents of children discharged from PICU.
152631|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
152671|NCT01736696|P4|Participant Flow|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
173019|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
152592|NCT01737268|B1|Baseline|FK949E Elderly Participants|After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator’s discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.
152593|NCT01737268|P1|Participant Flow|FK949E Elderly Participants|After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator’s discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.
152594|NCT01737268|O1|Outcome|FK949E Elderly Participants|After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator’s discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.
152595|NCT01737268|O1|Outcome|FK949E Elderly Participants|After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator’s discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.
152596|NCT01737268|O1|Outcome|FK949E Elderly Participant|After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator’s discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period
152597|NCT01737268|O1|Outcome|FK949E Elderly Participants|After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator’s discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.
152598|NCT01737268|O1|Outcome|FK949E Elderly Participants|After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator’s discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.
152599|NCT01737268|O1|Outcome|FK949E Elderly Participants|After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator’s discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.
152600|NCT01737268|O1|Outcome|FK949E Elderly Participants|After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator’s discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.
152601|NCT01737268|O1|Outcome|FK949E Elderly Participants|After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator’s discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.
152602|NCT01737268|O1|Outcome|FK949E Elderly Participants|After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator’s discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.
152603|NCT01737268|E1|Reported Event|FK949E Elderly Participants|After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator’s discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.
152604|NCT01737021|B3|Baseline|Total|Total of all reporting groups
153072|NCT01736553|O1|Outcome|Correlation With TIMPSI|
152608|NCT01737021|P1|Participant Flow|Psycho-educational Intervention|"Psycho-education~Psycho-education: The information given to parents will cover expected reactions that follow a PICU admission; how parents can help their child cope with these reactions; how to recognise warning signs; and sign-posting of appropriate follow-up services (if relevant). There will also be a follow-up telephone call to reinforce the information and to support parents in putting it in to practice, if appropriate."
152609|NCT01737021|O2|Outcome|Study Design|There were also six feasibility criteria related to the study design, covering recruitment/ participation rate, acceptability of procedures, loss to follow-up rate, and the time-scale of data collection.
152610|NCT01737021|O1|Outcome|Intervention|There were six feasibility criteria related to the intervention, covering aspects of the timing of the intervention, compliance, and evaluation.
152611|NCT01737021|E2|Reported Event|Treatment as Usual|There is no existing standard follow up for parents of children discharged from PICU.
152612|NCT01737021|E1|Reported Event|Psycho-educational Intervention|Received psycho-educational intervention.
152613|NCT01736930|B1|Baseline|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
152614|NCT01736930|P1|Participant Flow|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
152615|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
152616|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
152617|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
152618|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
152619|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
152620|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
152621|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
152622|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
152623|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
152624|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
152625|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
152626|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
152627|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
152628|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
152629|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
152630|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
152632|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
152633|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
152634|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
152635|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
152636|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
152637|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
152638|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
152639|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
152640|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
152641|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
152642|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
152643|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
152644|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
152645|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
152646|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
152647|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
152648|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
152649|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
152650|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
152651|NCT01736930|E2|Reported Event|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
152652|NCT01736930|E1|Reported Event|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
152653|NCT01736917|B1|Baseline|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m^2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8~PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods~Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
152654|NCT01736917|P1|Participant Flow|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m^2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8~PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods~Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
152655|NCT01736917|O1|Outcome|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8~PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods~Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
152656|NCT01736917|O1|Outcome|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8~PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods~Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
152657|NCT01736917|O1|Outcome|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8~PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
152658|NCT01736917|O1|Outcome|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8 PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
152659|NCT01736917|E1|Reported Event|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8~PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods~Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
152660|NCT01736696|B8|Baseline|Total|Total of all reporting groups
152661|NCT01736696|B7|Baseline|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152662|NCT01736696|B6|Baseline|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152663|NCT01736696|B5|Baseline|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152664|NCT01736696|B4|Baseline|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152665|NCT01736696|B3|Baseline|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152666|NCT01736696|B2|Baseline|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152667|NCT01736696|B1|Baseline|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152668|NCT01736696|P7|Participant Flow|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152669|NCT01736696|P6|Participant Flow|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152670|NCT01736696|P5|Participant Flow|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152672|NCT01736696|P3|Participant Flow|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152673|NCT01736696|P2|Participant Flow|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152674|NCT01736696|P1|Participant Flow|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152675|NCT01736696|O3|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152676|NCT01736696|O2|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152677|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152678|NCT01736696|O4|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152679|NCT01736696|O3|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152680|NCT01736696|O2|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152681|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152682|NCT01736696|O4|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152683|NCT01736696|O3|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152684|NCT01736696|O2|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152685|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152686|NCT01736696|O4|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152687|NCT01736696|O3|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152688|NCT01736696|O2|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152689|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152690|NCT01736696|O3|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152691|NCT01736696|O2|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152692|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152693|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152694|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152695|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152696|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152697|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152698|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152699|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152700|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152701|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152702|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152703|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152704|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152705|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152706|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152707|NCT01736696|O1|Outcome|All CP-690,550 Treated Participants|Included all participants who received either CP-690,550 OPC or CP-690,550 tablets for 14 days.
152708|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152709|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152710|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152711|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152712|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152713|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152714|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152715|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152716|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152717|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152718|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152719|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152720|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152721|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152722|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152723|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152724|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152725|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152726|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152727|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152728|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152729|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152730|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152731|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152732|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152733|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152734|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152735|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152736|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152737|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152738|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152739|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152740|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152741|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152742|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152743|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152744|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152745|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152746|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152747|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152748|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152749|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152750|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152751|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152752|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152753|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152754|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152755|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152756|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152757|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152758|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152759|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152760|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152761|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152762|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152763|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152764|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152765|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152766|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152767|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152768|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152769|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
153073|NCT01736553|O2|Outcome|Healthy Controls|Healthy control infants
152770|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152771|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152772|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152773|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152774|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152775|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152776|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152777|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152778|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152779|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152780|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152781|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152782|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152783|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152784|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152785|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152786|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152787|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152788|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152789|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152790|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152791|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152792|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152793|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152794|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152795|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152796|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152797|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152798|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152799|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152800|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152801|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152802|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152803|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152804|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152805|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152806|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152807|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152808|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152809|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152810|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152811|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152812|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152813|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152814|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152815|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152816|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152817|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152818|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
153126|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
152819|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152820|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152821|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152822|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152823|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152824|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152825|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152826|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152827|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152828|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152829|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152830|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152831|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152832|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152833|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152834|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152835|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152836|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152837|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152838|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152839|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152840|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152841|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152842|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152843|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152844|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152845|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152846|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152847|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152848|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152849|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152850|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152851|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152852|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152853|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152854|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152855|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152856|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152857|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152858|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152859|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152860|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152861|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152862|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152863|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152864|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152865|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152866|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152867|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152868|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152869|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152870|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152871|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152872|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152873|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152874|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152875|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152876|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152877|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152878|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152879|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152880|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152881|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152882|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152883|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152884|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152885|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152886|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152887|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152888|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152889|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152890|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152891|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152892|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152893|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152894|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152895|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152896|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152897|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152898|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152899|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152900|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152901|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152902|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152903|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152904|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152905|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152906|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152907|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152908|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152909|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152910|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152911|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152912|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152913|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152914|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152915|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152916|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152917|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152918|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152919|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152920|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152921|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152922|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152923|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152924|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152925|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152926|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152927|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152928|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152929|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152930|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152931|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152932|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152933|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152934|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152935|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152936|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152937|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152938|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152939|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152940|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152941|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152942|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152943|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152944|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152945|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152946|NCT01736696|O2|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152947|NCT01736696|O1|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152948|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152949|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152950|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152951|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152952|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152953|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152954|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152955|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152956|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152957|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152958|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152959|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152960|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152961|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152962|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152963|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152964|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152965|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152966|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152967|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152968|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152969|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152970|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152971|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152972|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152973|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152974|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152975|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152976|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152977|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152978|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152979|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152980|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152981|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152982|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152983|NCT01736696|E7|Reported Event|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
152984|NCT01736696|E6|Reported Event|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
152985|NCT01736696|E5|Reported Event|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
152986|NCT01736696|E4|Reported Event|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
152987|NCT01736696|E3|Reported Event|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
152988|NCT01736696|E2|Reported Event|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
152989|NCT01736696|E1|Reported Event|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
152990|NCT01736657|B1|Baseline|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
152991|NCT01736657|P1|Participant Flow|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
152992|NCT01736657|O1|Outcome|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
152993|NCT01736657|O1|Outcome|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
152994|NCT01736657|O1|Outcome|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
152995|NCT01736657|O1|Outcome|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
152996|NCT01736657|E1|Reported Event|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
152997|NCT01736579|B3|Baseline|Total|Total of all reporting groups
152998|NCT01736579|B2|Baseline|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
152999|NCT01736579|B1|Baseline|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
153000|NCT01736579|P2|Participant Flow|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
153001|NCT01736579|P1|Participant Flow|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
153002|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
153003|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
153004|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
153005|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
153006|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
153007|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
153008|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
153009|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
153010|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
153011|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
153012|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
153013|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
153014|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
153015|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
153016|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
153017|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
153018|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
153019|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
153020|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
153021|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
153022|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
153023|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
153024|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
153025|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
153026|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
153027|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
153028|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
153029|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
153030|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
153031|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
153032|NCT01736579|E2|Reported Event|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks.
153033|NCT01736579|E1|Reported Event|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks.
153034|NCT01736553|B3|Baseline|Total|Total of all reporting groups
153035|NCT01736553|B2|Baseline|Healthy Controls|Healthy control infants
153036|NCT01736553|B1|Baseline|Infants With Spinal Muscular Atrophy|Infants diagnosed Spinal Muscular Atrophy
153037|NCT01736553|P2|Participant Flow|Healthy Controls|Healthy control infants
153038|NCT01736553|P1|Participant Flow|Infants With Spinal Muscular Atrophy|Infants diagnosed Spinal Muscular Atrophy
153039|NCT01736553|O2|Outcome|Correlation With CHOP-INTEND|Infants diagnosed with SMA (SMN=2)
153040|NCT01736553|O1|Outcome|Correlation With TIMPSI|Infants diagnosed with SMA (SMN=2)
153041|NCT01736553|O2|Outcome|Correlation With CHOP-INTEND|Infants diagnosed with SMA (SMN=2)
153042|NCT01736553|O1|Outcome|Correlation With TIMPSI|Infants diagnosed with SMA (SMN=2)
153043|NCT01736553|O2|Outcome|Correlation With CHOP-INTEND|Infants diagnosed Spinal Muscular Atrophy (SMN=2)
153044|NCT01736553|O1|Outcome|Correlation With TIMPSI|Infants diagnosed Spinal Muscular Atrophy (SMN=2)
153045|NCT01736553|O2|Outcome|Correlation With CHOP-INTEND|Infants Diagnosed with SMN=2
153046|NCT01736553|O1|Outcome|Correlation With TIMPSI|Infants Diagnosed with SMN=2
153047|NCT01736553|O2|Outcome|Healthy Controls|Healthy control infants
153048|NCT01736553|O1|Outcome|Infants With Spinal Muscular Atrophy (SMN=2)|Infants diagnosed Spinal Muscular Atrophy (SMN=2)
153049|NCT01736553|O2|Outcome|Healthy Controls|Healthy control infants
153050|NCT01736553|O1|Outcome|Infants With Spinal Muscular Atrophy (SMN=2)|Infants diagnosed Spinal Muscular Atrophy (SMN=2)
153051|NCT01736553|O2|Outcome|Healthy Controls|Healthy control infants
153052|NCT01736553|O1|Outcome|Infants With Spinal Muscular Atrophy (SMN=2)|Infants diagnosed Spinal Muscular Atrophy (SMN=2)
153053|NCT01736553|O2|Outcome|Healthy Controls|Healthy control infants
153054|NCT01736553|O1|Outcome|Infants With Spinal Muscular Atrophy (SMN=2)|Infants diagnosed Spinal Muscular Atrophy (SMN=2)
153055|NCT01736553|O1|Outcome|Infants With Spinal Muscular Atrophy (SMN=2)|Infants diagnosed Spinal Muscular Atrophy (SMN=2)
153056|NCT01736553|O2|Outcome|Healthy Controls|Healthy control infants
153057|NCT01736553|O1|Outcome|Infants With Spinal Muscular Atrophy (SMN=2)|Infants diagnosed Spinal Muscular Atrophy (SMN=2)
153058|NCT01736553|O1|Outcome|Estimated Hazard Ratio|Proportional hazards regression models used to determine if motor function scores, mRNA, and protein levels predict death in SMA subjects
153059|NCT01736553|O2|Outcome|Correlation With AIMS|Healthy Control Subjects Motor Test- AIMS correlated with weight
153060|NCT01736553|O1|Outcome|Correlation With TIMPSI|Healthy Control Subjects Motor Test- TIMPSI correlated with weight
153061|NCT01736553|O2|Outcome|Correlation With AIMS|Healthy Control Subjects Motor Test- AIMS correlated with the mRNA
153062|NCT01736553|O1|Outcome|Correlation With TIMPSI|Healthy Control Subjects Motor Test- TIMPSI correlated with the mRNA
153063|NCT01736553|O2|Outcome|Correlation With AIMS|Healthy Control Subjects Motor Test- AIMS correlated with the CMAP exam
153064|NCT01736553|O1|Outcome|Correlation With TIMPSI|Healthy Control Subjects Motor Test- TIMPSI correlated with the CMAP exam
153065|NCT01736553|O2|Outcome|Correlation With CHOP-INTEND|
153066|NCT01736553|O1|Outcome|Correlation With TIMPSI|
153067|NCT01736553|O2|Outcome|Correlation With TIMPSI|
153068|NCT01736553|O1|Outcome|Correlation With CHOP-INTEND|
153069|NCT01736553|O2|Outcome|Correlation With CHOP-INTEND|
153070|NCT01736553|O1|Outcome|Correlation With TIMPSI|
153071|NCT01736553|O2|Outcome|Correlation With CHOP-INTEND|
153074|NCT01736553|O1|Outcome|Infants With Spinal Muscular Atrophy|Infants diagnosed Spinal Muscular Atrophy
153075|NCT01736553|O2|Outcome|Healthy Controls|Healthy control infants
153076|NCT01736553|O1|Outcome|Infants With Spinal Muscular Atrophy|Infants diagnosed Spinal Muscular Atrophy
153077|NCT01736553|O2|Outcome|Healthy Controls|Healthy control infants
153078|NCT01736553|O1|Outcome|Infants With Spinal Muscular Atrophy|Infants diagnosed Spinal Muscular Atrophy
153079|NCT01736553|O2|Outcome|Healthy Controls|Healthy control infants
153080|NCT01736553|O1|Outcome|Infants With Spinal Muscular Atrophy|Infants diagnosed Spinal Muscular Atrophy
153081|NCT01736553|O2|Outcome|Healthy Controls|Healthy control infants
153082|NCT01736553|O1|Outcome|Infants With Spinal Muscular Atrophy|Infants diagnosed Spinal Muscular Atrophy
153083|NCT01736553|O1|Outcome|Infants With Spinal Muscular Atrophy|Infants diagnosed Spinal Muscular Atrophy
153084|NCT01736553|O2|Outcome|Healthy Controls|Healthy control infants
153085|NCT01736553|O1|Outcome|Infants With Spinal Muscular Atrophy|Infants diagnosed Spinal Muscular Atrophy
153086|NCT01736553|E2|Reported Event|Healthy Controls|Healthy control infants
153087|NCT01736553|E1|Reported Event|Infants With Spinal Muscular Atrophy|Infants diagnosed Spinal Muscular Atrophy
153088|NCT01736540|B1|Baseline|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
153089|NCT01736540|P1|Participant Flow|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
153090|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
153091|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
153092|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
153093|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
153094|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
153095|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
153096|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
153097|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
153098|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
153099|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
153100|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
153101|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
153102|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
153103|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
153104|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
153105|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
153106|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
153107|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
153108|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
153109|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
153110|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
153111|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
153112|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
153113|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
153114|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
153115|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
153116|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
153117|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
153118|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
153119|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
153120|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
153121|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
153122|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
153123|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
153124|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
153125|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
173020|NCT01665170|O1|Outcome|Placebo|Placebo arm
153127|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
153128|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
153129|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
153130|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
153131|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
153132|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
153133|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
153134|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
153135|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
153136|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
153137|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
153138|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
153139|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
153140|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
153141|NCT01736540|E4|Reported Event|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
153142|NCT01736540|E3|Reported Event|Other Anaemia|Subset of overall participants with other types of anaemias
153143|NCT01736540|E2|Reported Event|Myelodysplastic Syndrome (MDS)|Subset of overall participants with MDS
153144|NCT01736540|E1|Reported Event|Thalassaemia Major|Subset of overall participants with thalassemia major
153145|NCT01736527|B1|Baseline|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.~LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
153146|NCT01736527|P1|Participant Flow|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.~LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
153147|NCT01736527|O1|Outcome|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.~LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
153148|NCT01736527|O1|Outcome|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.~LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
153149|NCT01736527|O1|Outcome|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.~LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
153150|NCT01736527|O1|Outcome|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.~LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
153151|NCT01736527|E1|Reported Event|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.~LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
153152|NCT01736475|B3|Baseline|Total|Total of all reporting groups
153153|NCT01736475|B2|Baseline|On-demand|
153154|NCT01736475|B1|Baseline|Prophylaxis|
153155|NCT01736475|P2|Participant Flow|On-demand|10 to 60 ± 5 IU/kg
153156|NCT01736475|P1|Participant Flow|Prophylaxis|Twice weekly at a dose of 45 ± 5 IU/kg
153157|NCT01736475|O2|Outcome|On-demand|
153158|NCT01736475|O1|Outcome|Prophylaxis|
153159|NCT01736475|O2|Outcome|On-demand|
153160|NCT01736475|O1|Outcome|Prophylaxis|
153161|NCT01736475|O2|Outcome|On-demand|
153162|NCT01736475|O1|Outcome|Prophylaxis|
153163|NCT01736475|O2|Outcome|On-demand|
153164|NCT01736475|O1|Outcome|Prophylaxis|
153165|NCT01736475|O2|Outcome|On-demand|
153166|NCT01736475|O1|Outcome|Prophylaxis|
153167|NCT01736475|O2|Outcome|On-demand|
153168|NCT01736475|O1|Outcome|Prophylaxis|
153169|NCT01736475|O2|Outcome|On-demand|
153170|NCT01736475|O1|Outcome|Prophylaxis|
153171|NCT01736475|O2|Outcome|On-demand|
153172|NCT01736475|O1|Outcome|Prophylaxis|
153173|NCT01736475|O2|Outcome|On-demand|
153174|NCT01736475|O1|Outcome|Prophylaxis|
153175|NCT01736475|O2|Outcome|On-demand|
153176|NCT01736475|O1|Outcome|Prophylaxis|
153177|NCT01736475|O2|Outcome|On-deamand|
153178|NCT01736475|O1|Outcome|Prophylaxis|
153179|NCT01736475|O2|Outcome|On-demand|
153180|NCT01736475|O1|Outcome|Prophylaxis|
153181|NCT01736475|O2|Outcome|On-demand|
153182|NCT01736475|O1|Outcome|Prophylaxis|
153183|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
153184|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
153185|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
153186|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
153187|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
153188|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
153189|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
153190|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
153191|NCT01736475|O2|Outcome|On-demand|Participants with both baseline and study completion SF-36 Scores
153192|NCT01736475|O1|Outcome|Prophylaxis|Participants with both baseline and study completion SF-36 Scores
153193|NCT01736475|O2|Outcome|On-demand|Participants with both baseline and study completion HAEMO-SYM scores
153194|NCT01736475|O1|Outcome|Prophylaxis|Participants with both baseline and study completion HAEMO-SYM scores
153195|NCT01736475|O2|Outcome|On-demand|10 to 60 ± 5 IU/kg
153196|NCT01736475|O1|Outcome|Prophylaxis|Twice weekly at a dose of 45 ± 5 IU/kg
153197|NCT01736475|O1|Outcome|All Study Participants|All Study Participants who received at least one infusion of BAX855.
153198|NCT01736475|O1|Outcome|All Study Participants|All Study Participants who received at least one infusion of BAX855.
153199|NCT01736475|O1|Outcome|All Study Participants|
153200|NCT01736475|O2|Outcome|On-demand|
153201|NCT01736475|O1|Outcome|Prophylaxis|
153202|NCT01736475|O2|Outcome|On-demand|
153203|NCT01736475|O1|Outcome|Prophylaxis|Break-through bleeds during prophylaxis
153204|NCT01736475|O1|Outcome|Participants With a Bleeding Episode|All bleeding episodes treated with BAX 855 in participants on on-demand and prophylaxis treatment regimens.
153205|NCT01736475|O2|Outcome|On-demand|
153206|NCT01736475|O1|Outcome|Prophylaxis|
153207|NCT01736475|E1|Reported Event|All Study Participants|All study participants were analyzed in a single arm/group.
153208|NCT01736397|B3|Baseline|Total|Total of all reporting groups
153209|NCT01736397|B2|Baseline|Placebo|"Placebo will be taken with or within one hour of meals or snacks. The number of placebo pills will depend on the patient's serum phosphorus results at each treatment visit.~Placebo"
153210|NCT01736397|B1|Baseline|Ferric Citrate|"Ferric citrate will be taken with or within one hour of meals or snacks. The dose of ferric citrate will depend on the patient's serum phosphorus results at each treatment visit.~Ferric Citrate: Dose depends on serum phosphorus levels collected at each study visit."
153211|NCT01736397|P2|Participant Flow|Placebo|"Placebo will be taken with or within one hour of meals or snacks. The number of placebo pills will depend on the patient's serum phosphorus results at each treatment visit.~Placebo"
153212|NCT01736397|P1|Participant Flow|Ferric Citrate|"Ferric citrate will be taken with or within one hour of meals or snacks. The dose of ferric citrate will depend on the patient's serum phosphorus results at each treatment visit.~Ferric Citrate: Dose depends on serum phosphorus levels collected at each study visit."
153213|NCT01736397|O2|Outcome|Placebo|"Placebo will be taken with or within one hour of meals or snacks. The number of placebo pills will depend on the patient's serum phosphorus results at each treatment visit.~Placebo"
153214|NCT01736397|O1|Outcome|Ferric Citrate|"Ferric citrate will be taken with or within one hour of meals or snacks. The dose of ferric citrate will depend on the patient's serum phosphorus results at each treatment visit.~Ferric Citrate: Dose depends on serum phosphorus levels collected at each study visit."
153215|NCT01736397|O2|Outcome|Placebo|"Placebo will be taken with or within one hour of meals or snacks. The number of placebo pills will depend on the patient's serum phosphorus results at each treatment visit.~Placebo"
153216|NCT01736397|O1|Outcome|Ferric Citrate|"Ferric citrate will be taken with or within one hour of meals or snacks. The dose of ferric citrate will depend on the patient's serum phosphorus results at each treatment visit.~Ferric Citrate: Dose depends on serum phosphorus levels collected at each study visit."
153217|NCT01736397|O2|Outcome|Placebo|"Placebo will be taken with or within one hour of meals or snacks. The number of placebo pills will depend on the patient's serum phosphorus results at each treatment visit.~Placebo"
153218|NCT01736397|O1|Outcome|Ferric Citrate|"Ferric citrate will be taken with or within one hour of meals or snacks. The dose of ferric citrate will depend on the patient's serum phosphorus results at each treatment visit.~Ferric Citrate: Dose depends on serum phosphorus levels collected at each study visit."
153219|NCT01736397|O2|Outcome|Placebo|"Placebo will be taken with or within one hour of meals or snacks. The number of placebo pills will depend on the patient's serum phosphorus results at each treatment visit.~Placebo"
153220|NCT01736397|O1|Outcome|Ferric Citrate|"Ferric citrate will be taken with or within one hour of meals or snacks. The dose of ferric citrate will depend on the patient's serum phosphorus results at each treatment visit.~Ferric Citrate: Dose depends on serum phosphorus levels collected at each study visit."
153221|NCT01736397|E2|Reported Event|Placebo|"Placebo will be taken with or within one hour of meals or snacks. The number of placebo pills will depend on the patient's serum phosphorus results at each treatment visit.~Placebo"
153222|NCT01736397|E1|Reported Event|Ferric Citrate|"Ferric citrate will be taken with or within one hour of meals or snacks. The dose of ferric citrate will depend on the patient's serum phosphorus results at each treatment visit.~Ferric Citrate: Dose depends on serum phosphorus levels collected at each study visit."
153223|NCT01736215|B1|Baseline|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
153224|NCT01736215|P1|Participant Flow|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
153225|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
153226|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
153227|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
153228|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
153229|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
153230|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
153231|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
153232|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
153233|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
153234|NCT01736215|E1|Reported Event|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
153235|NCT01736176|B1|Baseline|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153236|NCT01736176|P1|Participant Flow|Levodopa-Carbidopa Intestinal Gel (LCIG)|Participants had a percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually. The starting total daily dose of LCIG was based solely on the daily dose of the oral levodopa taken immediately prior to Day 1 and was adjusted to obtain the optimal clinical response for the individual participant. Participants received treatment for up to 60 weeks; participants who completed their Week 60 visit before LCIG was commercially available had the option to extend their LCIG therapy, if in the opinion of the investigator, the participant would benefit from continued LCIG treatment.
153237|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153238|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153239|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153240|NCT01736176|O2|Outcome|Week 60|
153241|NCT01736176|O1|Outcome|Week 12|
153242|NCT01736176|O2|Outcome|Week 60|
153243|NCT01736176|O1|Outcome|Week 12|
153244|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153245|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153246|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153247|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153248|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153249|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153290|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
173021|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
153250|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153251|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153252|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153253|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153254|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153255|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153256|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153257|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153258|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153259|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153260|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153261|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153262|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153263|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153264|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153265|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153266|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153398|NCT01735201|O6|Outcome|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
153267|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153268|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153269|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153270|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153271|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153272|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153273|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153274|NCT01736176|O2|Outcome|Overall|Any adverse events that began or worsened in severity on or after the date of the first PEG-J placement procedure and no more than 30 days after the end of the LCIG Treatment Period.
153275|NCT01736176|O1|Outcome|Week 1-4|Any adverse events that began or worsened in severity on or after the date of the first PEG-J placement procedure through week 4.
153276|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153277|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153278|NCT01736176|E1|Reported Event|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
153279|NCT01735916|B4|Baseline|Total|Total of all reporting groups
153280|NCT01735916|B3|Baseline|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
153281|NCT01735916|B2|Baseline|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
153282|NCT01735916|B1|Baseline|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P device and were not randomized.
153283|NCT01735916|P3|Participant Flow|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
153284|NCT01735916|P2|Participant Flow|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
153285|NCT01735916|P1|Participant Flow|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P device and were not randomized.
153286|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
153287|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
153288|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
153289|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
153291|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
153292|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
153293|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
153294|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
153295|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
153296|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
153297|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
153298|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
153299|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
153300|NCT01735916|E3|Reported Event|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
153301|NCT01735916|E2|Reported Event|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
153302|NCT01735916|E1|Reported Event|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P device and were not randomized.
153303|NCT01735877|B3|Baseline|Total|Total of all reporting groups
153304|NCT01735877|B2|Baseline|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
153305|NCT01735877|B1|Baseline|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
153306|NCT01735877|P2|Participant Flow|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
153307|NCT01735877|P1|Participant Flow|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
153308|NCT01735877|O2|Outcome|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
153309|NCT01735877|O1|Outcome|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
153310|NCT01735877|O2|Outcome|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
153399|NCT01735201|O5|Outcome|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
153400|NCT01735201|O4|Outcome|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
153311|NCT01735877|O1|Outcome|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
153312|NCT01735877|O2|Outcome|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
153313|NCT01735877|O1|Outcome|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
153314|NCT01735877|O2|Outcome|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
153315|NCT01735877|O1|Outcome|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
153316|NCT01735877|O2|Outcome|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
153317|NCT01735877|O1|Outcome|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
153318|NCT01735877|E2|Reported Event|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
153319|NCT01735877|E1|Reported Event|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
153320|NCT01735630|B3|Baseline|Total|Total of all reporting groups
153321|NCT01735630|B2|Baseline|Placebo|"Matched placebo BID for 12 weeks~Placebo"
153322|NCT01735630|B1|Baseline|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
153323|NCT01735630|P2|Participant Flow|Placebo|"Matched placebo BID for 12 weeks~Placebo"
153324|NCT01735630|P1|Participant Flow|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
153325|NCT01735630|O2|Outcome|Placebo|"Matched placebo BID for 12 weeks~Placebo"
153326|NCT01735630|O1|Outcome|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
153327|NCT01735630|O2|Outcome|Placebo|"Matched placebo BID for 12 weeks~Placebo"
153328|NCT01735630|O1|Outcome|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
153329|NCT01735630|O2|Outcome|Placebo|"Matched placebo BID for 12 weeks~Placebo"
153330|NCT01735630|O1|Outcome|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
153331|NCT01735630|O2|Outcome|Placebo|"Matched placebo BID for 12 weeks~Placebo"
153332|NCT01735630|O1|Outcome|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
153333|NCT01735630|O2|Outcome|Placebo|"Matched placebo BID for 12 weeks~Placebo"
153334|NCT01735630|O1|Outcome|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
153335|NCT01735630|E2|Reported Event|Placebo|"Matched placebo BID for 12 weeks~Placebo"
153336|NCT01735630|E1|Reported Event|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
153337|NCT01735617|B1|Baseline|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response~Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
153401|NCT01735201|O3|Outcome|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
153338|NCT01735617|P1|Participant Flow|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response~Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
153339|NCT01735617|O1|Outcome|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response~Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
153340|NCT01735617|O1|Outcome|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response~Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
153341|NCT01735617|O1|Outcome|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response~Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
153342|NCT01735617|O1|Outcome|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response~Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
153343|NCT01735617|O1|Outcome|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response~Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
153344|NCT01735617|O1|Outcome|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response~Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
153345|NCT01735617|O1|Outcome|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response~Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
153346|NCT01735617|O1|Outcome|Chronocort|Chronocort Modified Release Capsules 10mg twice-daily
153347|NCT01735617|O1|Outcome|Chroncort|Chronocort Modified Release Capsules 10mg twice-daily
153348|NCT01735617|O1|Outcome|Chronocort|Chronocort Modified Release Capsules 10 mg twice-daily.
153349|NCT01735617|E1|Reported Event|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response~Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
153350|NCT01735396|B1|Baseline|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
153351|NCT01735396|P1|Participant Flow|Abiraterone Acetate|"Abiraterone acetate 1000mg orally daily until the time of disease progression, in the absence of prohibitive toxicities.~Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily"
153352|NCT01735396|O1|Outcome|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
153353|NCT01735396|O1|Outcome|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
153354|NCT01735396|O1|Outcome|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
153355|NCT01735396|O1|Outcome|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
153356|NCT01735396|O1|Outcome|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
153357|NCT01735396|O1|Outcome|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
153358|NCT01735396|E1|Reported Event|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
153359|NCT01735214|B1|Baseline|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
153360|NCT01735214|P1|Participant Flow|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
153361|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
153362|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
153363|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
153364|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
153365|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
153366|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
153367|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
153368|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
153369|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
153370|NCT01735214|E1|Reported Event|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
153371|NCT01735201|B9|Baseline|Total|Total of all reporting groups
153372|NCT01735201|B8|Baseline|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
153373|NCT01735201|B7|Baseline|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
153374|NCT01735201|B6|Baseline|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
153375|NCT01735201|B5|Baseline|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
153376|NCT01735201|B4|Baseline|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
153377|NCT01735201|B3|Baseline|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
153378|NCT01735201|B2|Baseline|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
153379|NCT01735201|B1|Baseline|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
153380|NCT01735201|P8|Participant Flow|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
153381|NCT01735201|P7|Participant Flow|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
153382|NCT01735201|P6|Participant Flow|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
153383|NCT01735201|P5|Participant Flow|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
153384|NCT01735201|P4|Participant Flow|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
153385|NCT01735201|P3|Participant Flow|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
153386|NCT01735201|P2|Participant Flow|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
153387|NCT01735201|P1|Participant Flow|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
153388|NCT01735201|O8|Outcome|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
153389|NCT01735201|O7|Outcome|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
153390|NCT01735201|O6|Outcome|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
153391|NCT01735201|O5|Outcome|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
153392|NCT01735201|O4|Outcome|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
153393|NCT01735201|O3|Outcome|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
153394|NCT01735201|O2|Outcome|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
153395|NCT01735201|O1|Outcome|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
153396|NCT01735201|O8|Outcome|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
153397|NCT01735201|O7|Outcome|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
153402|NCT01735201|O2|Outcome|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
153403|NCT01735201|O1|Outcome|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
153404|NCT01735201|O8|Outcome|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
153405|NCT01735201|O7|Outcome|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
153406|NCT01735201|O6|Outcome|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
153407|NCT01735201|O5|Outcome|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
153408|NCT01735201|O4|Outcome|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
153409|NCT01735201|O3|Outcome|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
153410|NCT01735201|O2|Outcome|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
153411|NCT01735201|O1|Outcome|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
153412|NCT01735201|E8|Reported Event|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
153413|NCT01735201|E7|Reported Event|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
153414|NCT01735201|E6|Reported Event|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
153415|NCT01735201|E5|Reported Event|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
153416|NCT01735201|E4|Reported Event|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
153417|NCT01735201|E3|Reported Event|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
153418|NCT01735201|E2|Reported Event|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
153419|NCT01735201|E1|Reported Event|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
153420|NCT01735175|B3|Baseline|Total|Total of all reporting groups
153421|NCT01735175|B2|Baseline|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
153422|NCT01735175|B1|Baseline|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
153423|NCT01735175|P2|Participant Flow|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
153424|NCT01735175|P1|Participant Flow|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
153425|NCT01735175|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
153426|NCT01735175|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
153427|NCT01735175|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
153428|NCT01735175|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
153429|NCT01735175|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
153430|NCT01735175|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
153431|NCT01735175|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
153432|NCT01735175|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
153433|NCT01735175|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
153434|NCT01735175|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
173022|NCT01665170|O1|Outcome|Placebo|Placebo arm
153435|NCT01735175|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
153436|NCT01735175|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
153437|NCT01735175|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
153438|NCT01735175|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
153439|NCT01735175|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
153440|NCT01735175|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
153441|NCT01735175|E2|Reported Event|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
153442|NCT01735175|E1|Reported Event|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
153443|NCT01734993|B1|Baseline|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
153444|NCT01734993|P1|Participant Flow|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 long term extension (LTE) study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of greater than [>] 1.2 points) were administered tocilizumab (TCZ) in this long-term extension study, at a dose of 162 milligrams (mg) as subcutaneous (SC) injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
153445|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
153446|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
153447|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
153448|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
153449|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
153450|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
153451|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
153559|NCT01734239|O2|Outcome|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
162015|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
153452|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
153453|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
153454|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
153455|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
153456|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
153457|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
153458|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
153459|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
153460|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
153461|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
153462|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
153463|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
153464|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
153465|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
153466|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
154066|NCT01732588|E1|Reported Event|Regimen A - 120mg OZ439 PIB|Single oral dose of 120 mg OZ439 as powder in bottle (PIB) formulation.
153467|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
153468|NCT01734993|E1|Reported Event|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
153469|NCT01734889|B1|Baseline|Orfadin Suspension|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
153470|NCT01734889|P1|Participant Flow|Orfadin Suspension|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
153471|NCT01734889|O1|Outcome|Age 5-<18 Years|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
153472|NCT01734889|O1|Outcome|Age 5-<18 Years|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
153473|NCT01734889|O1|Outcome|Age 5-<18 Years|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
153474|NCT01734889|O1|Outcome|Age <5 Years|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
153475|NCT01734889|O1|Outcome|Age 5-<18 Years|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
153476|NCT01734889|E1|Reported Event|Orfadin Suspension|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
153477|NCT01734785|B4|Baseline|Total|Total of all reporting groups
153478|NCT01734785|B3|Baseline|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
153479|NCT01734785|B2|Baseline|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
153480|NCT01734785|B1|Baseline|Empagliflozin 25 mg|Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
153481|NCT01734785|P4|Participant Flow|Linagliptin 5 mg|Patients received 5mg dose of Linagliptin (lina 5), administered orally, once daily for 16 weeks during the OL treatment period, thereafter patients received 1 matching placebo tablet to FDC empa 25/lina 5, and 1 matching placebo tablet to FDC empa 10/lina 5 per day in addition to lina 5 OL, for 1 week during the open-label placebo add-on treatment period.
153482|NCT01734785|P3|Participant Flow|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
153483|NCT01734785|P2|Participant Flow|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
153484|NCT01734785|P1|Participant Flow|Empagliflozin 25 mg|Patients received 1 fixed dose combination (FDC) Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
153485|NCT01734785|O3|Outcome|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
153486|NCT01734785|O2|Outcome|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
153487|NCT01734785|O1|Outcome|Empagliflozin 25 mg|Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
153488|NCT01734785|O3|Outcome|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
153489|NCT01734785|O2|Outcome|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
153490|NCT01734785|O1|Outcome|Empagliflozin 25 mg|Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
153491|NCT01734785|O3|Outcome|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
153492|NCT01734785|O2|Outcome|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
153493|NCT01734785|O1|Outcome|Empagliflozin 25 mg|Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
153494|NCT01734785|E4|Reported Event|Linagliptin 5 mg|Patients received 5mg dose of Linagliptin (lina 5), administered orally, once daily for 16 weeks during the OL treatment period, thereafter patients received 1 matching placebo tablet to FDC empa 25/lina 5, and 1 matching placebo tablet to FDC empa 10/lina 5 per day in addition to lina 5 OL, for 1 week during the open-label placebo add-on treatment period.
153495|NCT01734785|E3|Reported Event|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
153496|NCT01734785|E2|Reported Event|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
153497|NCT01734785|E1|Reported Event|Empagliflozin 25 mg|Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
153498|NCT01734772|B3|Baseline|Total|Total of all reporting groups
153499|NCT01734772|B2|Baseline|Part 2|In part 2, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, 180 mg ticagrelor were given 2 hours after the morning dose of 110 mg dabigatran etexilate and dabigatran PK profile were taken on this day 1 of the test treatment.
153500|NCT01734772|B1|Baseline|Part 1|In part 1, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, ticagrelor treatment was added starting with the concomitant administration of a 180 mg ticagrelor loading dose followed by 90 mg ticagrelor twice daily. Dabigatran PK profiles were taken on day 1 of the test treatment and day 4 of the test treatment.
153501|NCT01734772|P2|Participant Flow|Part 2|In part 2, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, 180 mg ticagrelor were given 2 hours after the morning dose of 110 mg dabigatran etexilate and dabigatran PK profile were taken on this day 1 of the test treatment.
153502|NCT01734772|P1|Participant Flow|Part 1|In part 1, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, ticagrelor treatment was added starting with the concomitant administration of a 180 mg ticagrelor loading dose followed by 90 mg ticagrelor twice daily. Dabigatran PK profiles were taken on day 1 of the test treatment and day 4 of the test treatment.
153503|NCT01734772|O5|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 2|Dabigatran Etexilate 110mg morning dose followed by 180mg Ticagrelor 2 hours later.
153504|NCT01734772|O4|Outcome|Dabigratan Etexilate 110mg Bid Alone - Part 2|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
153505|NCT01734772|O3|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 90mg Bid - Part 1|Multiple dosing of 90 mg bid on days 2 and 3 and 90mg on day 4 together with Dabigatran Etexilate 110mg bid on days 2 and 3 and 110mg in the morning on day 4.
153506|NCT01734772|O2|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 1|Single loading dose of Ticagrelor 180 mg on day 1 together with Dabigatran Etexilate 110mg bid.
153507|NCT01734772|O1|Outcome|Dabigratan Etexilate 110mg Bid Alone - Part 1|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
153508|NCT01734772|O5|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 2|Dabigatran Etexilate 110mg morning dose followed by 180mg Ticagrelor 2 hours later.
153509|NCT01734772|O4|Outcome|Dabigratan Etexilate 110mg Bid Alone - Part 2|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
153510|NCT01734772|O3|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 90mg Bid - Part 1|Multiple dosing of 90 mg bid on days 2 and 3 and 90mg on day 4 together with Dabigatran Etexilate 110mg bid on days 2 and 3 and 110mg in the morning on day 4.
153511|NCT01734772|O2|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 1|Single loading dose of Ticagrelor 180 mg on day 1 together with Dabigatran Etexilate 110mg bid.
153512|NCT01734772|O1|Outcome|Dabigratan Etexilate 110mg Bid Alone - Part 1|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
153513|NCT01734772|E5|Reported Event|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 2|Dabigatran Etexilate 110mg morning dose followed by 180mg Ticagrelor 2 hours later.
153514|NCT01734772|E4|Reported Event|Dabigratan Etexilate 110mg Bid Alone - Part 2|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
153515|NCT01734772|E3|Reported Event|Dabigatran Etexilate 110mg Bid + Ticagrelor 90mg Bid - Part 1|Multiple dosing of 90 mg bid on days 2 and 3 and 90mg on day 4 together with Dabigatran Etexilate 110mg bid on days 2 and 3 and 110mg once on day 4.
153516|NCT01734772|E2|Reported Event|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 1|Single loading dose of Ticagrelor 180 mg on day 1 together with Dabigatran Etexilate 110mg bid.
153517|NCT01734772|E1|Reported Event|Dabigratan Etexilate 110mg Bid Alone - Part 1|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
153518|NCT01734655|B1|Baseline|All Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.
153560|NCT01734239|O1|Outcome|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
153561|NCT01734239|O2|Outcome|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
153562|NCT01734239|O1|Outcome|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
153519|NCT01734655|P1|Participant Flow|Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices in either a focus group format (the first 11 participants) or cognitive interview format (the last 29 participants).
153520|NCT01734655|O1|Outcome|Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.
153521|NCT01734655|O1|Outcome|Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.
153522|NCT01734655|O1|Outcome|Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.
153523|NCT01734655|O1|Outcome|All Participants|all participants
153524|NCT01734655|O1|Outcome|All Participants|All Participants
153525|NCT01734655|O1|Outcome|All Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.
153526|NCT01734655|E1|Reported Event|All Participants|Pregnant women who were overweight or obese and 18-40 yrs of age.
153527|NCT01734551|B3|Baseline|Total|Total of all reporting groups
153528|NCT01734551|B2|Baseline|Clonidine|"Dose is started at 5 mcg/kg/day, given PO with feeds, divided every 3-4 hours. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.~Clonidine: Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing."
153529|NCT01734551|B1|Baseline|Morphine|"Initial dose is 0.4mg/kg/day, divided every 3-4 hours, given PO with feeds. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.~Morphine: Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day.~Once stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is <0.1mg/kg/day, may discontinue."
153530|NCT01734551|P2|Participant Flow|Clonidine|"Dose is started at 5 mcg/kg/day, given PO with feeds, divided every 3-4 hours. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.~Clonidine: Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing."
153531|NCT01734551|P1|Participant Flow|Morphine|"Initial dose is 0.4mg/kg/day, divided every 3-4 hours, given PO with feeds. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.~Morphine: Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day.~Once stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is <0.1mg/kg/day, may discontinue."
153532|NCT01734551|O2|Outcome|Clonidine|"Dose is started at 5 mcg/kg/day, given PO with feeds, divided every 3-4 hours. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.~Clonidine: Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing."
153533|NCT01734551|O1|Outcome|Morphine|"Initial dose is 0.4mg/kg/day, divided every 3-4 hours, given PO with feeds. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.~Morphine: Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day.~Once stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is <0.1mg/kg/day, may discontinue."
153563|NCT01734239|O2|Outcome|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
153564|NCT01734239|O1|Outcome|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
154067|NCT01732549|B3|Baseline|Total|Total of all reporting groups
153534|NCT01734551|O2|Outcome|Clonidine|"Dose is started at 5 mcg/kg/day, given PO with feeds, divided every 3-4 hours. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.~Clonidine: Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing."
153535|NCT01734551|O1|Outcome|Morphine|"Initial dose is 0.4mg/kg/day, divided every 3-4 hours, given PO with feeds. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.~Morphine: Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day.~Once stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is <0.1mg/kg/day, may discontinue."
153536|NCT01734551|O2|Outcome|Clonidine|"Dose is started at 5 mcg/kg/day, given PO with feeds, divided every 3-4 hours. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.~Clonidine: Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing."
153537|NCT01734551|O1|Outcome|Morphine|"Initial dose is 0.4mg/kg/day, divided every 3-4 hours, given PO with feeds. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.~Morphine: Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day.~Once stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is <0.1mg/kg/day, may discontinue."
153538|NCT01734551|O2|Outcome|Clonidine|"Dose is started at 5 mcg/kg/day, given PO with feeds, divided every 3-4 hours. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.~Clonidine: Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing."
153539|NCT01734551|O1|Outcome|Morphine|"Initial dose is 0.4mg/kg/day, divided every 3-4 hours, given PO with feeds. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.~Morphine: Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day.~Once stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is <0.1mg/kg/day, may discontinue."
153540|NCT01734551|E2|Reported Event|Clonidine|"Dose is started at 5 mcg/kg/day, given PO with feeds, divided every 3-4 hours. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.~Clonidine: Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing."
153541|NCT01734551|E1|Reported Event|Morphine|"Initial dose is 0.4mg/kg/day, divided every 3-4 hours, given PO with feeds. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.~Morphine: Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day.~Once stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is <0.1mg/kg/day, may discontinue."
153542|NCT01734395|B1|Baseline|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
153543|NCT01734395|P1|Participant Flow|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
153544|NCT01734395|O1|Outcome|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
153545|NCT01734395|O1|Outcome|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
153546|NCT01734395|O1|Outcome|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
153547|NCT01734395|E1|Reported Event|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
153548|NCT01734317|B1|Baseline|Mepilex Transfer Ag|
153549|NCT01734317|P1|Participant Flow|Dressing|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: A soft silicone wound contact layer."
153550|NCT01734317|O1|Outcome|Dressing|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: A soft silicone wound contact layer."
153551|NCT01734317|E1|Reported Event|Dressing|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: A soft silicone wound contact layer."
153552|NCT01734239|B3|Baseline|Total|Total of all reporting groups
153553|NCT01734239|B2|Baseline|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
153554|NCT01734239|B1|Baseline|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
153555|NCT01734239|P2|Participant Flow|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
153556|NCT01734239|P1|Participant Flow|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
153557|NCT01734239|O2|Outcome|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
153558|NCT01734239|O1|Outcome|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
153565|NCT01734239|O2|Outcome|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
153566|NCT01734239|O1|Outcome|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
153567|NCT01734239|E1|Reported Event|Pneumovax™ 23|Participants received a single 0.5 mL intramuscular injection on Day 1
153568|NCT01734161|B3|Baseline|Total|Total of all reporting groups
153569|NCT01734161|B2|Baseline|Placebo|"One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.~Placebo: Subjects randomized to placebo receive 50cc normal saline"
153570|NCT01734161|B1|Baseline|Dexamethasone|"One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.~Dexamethasone: 8mg IV dexamethesone given"
153571|NCT01734161|P2|Participant Flow|Placebo|"One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.~Placebo: Subjects randomized to placebo receive 50cc normal saline"
153572|NCT01734161|P1|Participant Flow|Dexamethasone|"One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.~Dexamethasone: 8mg IV dexamethesone given"
153573|NCT01734161|O2|Outcome|Placebo|"One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.~Placebo: Subjects randomized to placebo receive 50cc normal saline"
153574|NCT01734161|O1|Outcome|Dexamethasone|"One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.~Dexamethasone: 8mg IV dexamethesone given"
153575|NCT01734161|E2|Reported Event|Placebo|"One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.~Placebo: Subjects randomized to placebo receive 50cc normal saline"
153576|NCT01734161|E1|Reported Event|Dexamethasone|"One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.~Dexamethasone: 8mg IV dexamethesone given"
153577|NCT01733953|B3|Baseline|Total|Total of all reporting groups
153578|NCT01733953|B2|Baseline|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
153579|NCT01733953|B1|Baseline|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
153580|NCT01733953|P2|Participant Flow|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
153581|NCT01733953|P1|Participant Flow|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
153582|NCT01733953|O2|Outcome|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
153583|NCT01733953|O1|Outcome|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
153584|NCT01733953|O2|Outcome|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
153585|NCT01733953|O1|Outcome|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
153586|NCT01733953|O2|Outcome|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
153587|NCT01733953|O1|Outcome|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
153588|NCT01733953|O2|Outcome|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
153589|NCT01733953|O1|Outcome|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
153590|NCT01733953|O2|Outcome|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
153591|NCT01733953|O1|Outcome|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
153592|NCT01733953|O2|Outcome|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
153593|NCT01733953|O1|Outcome|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
153594|NCT01733953|E2|Reported Event|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
153595|NCT01733953|E1|Reported Event|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
153596|NCT01733758|B5|Baseline|Total|Total of all reporting groups
153597|NCT01733758|B4|Baseline|Open Label Liraglutide 0.9 mg Daily|Participants received open label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
153598|NCT01733758|B3|Baseline|Albiglutide 50 mg Weekly|Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
153599|NCT01733758|B2|Baseline|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153600|NCT01733758|B1|Baseline|Placebo|Participants received double blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153601|NCT01733758|P4|Participant Flow|Open Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
153602|NCT01733758|P3|Participant Flow|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
173023|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
153603|NCT01733758|P2|Participant Flow|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153604|NCT01733758|P1|Participant Flow|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly to Week 52.
153605|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
153606|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
153607|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153608|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153609|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
153610|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
153611|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153612|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153613|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
153614|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
153615|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153616|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153617|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
153618|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
153619|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153620|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153621|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
153622|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
153623|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153624|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153625|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
153626|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
153627|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153628|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153629|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
153630|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
153631|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153711|NCT01733368|E1|Reported Event|Quadripolar Left Ventricular Lead (Quartet Lead)|Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead
153632|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153633|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
153634|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
153635|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153636|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153637|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
153638|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
153639|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153640|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153641|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
153642|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
153643|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153644|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153645|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
153646|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
153647|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153648|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153649|NCT01733758|E5|Reported Event|Open Label Liraglutide 0.9 mg Daily|Participants received open label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
153650|NCT01733758|E4|Reported Event|Albiglutide 50 mg Weekly|Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
153651|NCT01733758|E3|Reported Event|Albiglutide 30 mg Weekly|Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153652|NCT01733758|E2|Reported Event|Placebo - After Switch|(After Switch to 30 mg algiblutide) After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
153653|NCT01733758|E1|Reported Event|Placebo - Before Switch|(Before Switch to 30 mg albiglutide) Participants received double blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24.
153654|NCT01733745|B3|Baseline|Total|Total of all reporting groups
153655|NCT01733745|B2|Baseline|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
153656|NCT01733745|B1|Baseline|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
153657|NCT01733745|P2|Participant Flow|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
153658|NCT01733745|P1|Participant Flow|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
153659|NCT01733745|O2|Outcome|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
153660|NCT01733745|O1|Outcome|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
153661|NCT01733745|O2|Outcome|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
153662|NCT01733745|O1|Outcome|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
153663|NCT01733745|O2|Outcome|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
153664|NCT01733745|O1|Outcome|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
153665|NCT01733745|E2|Reported Event|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
153666|NCT01733745|E1|Reported Event|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
153667|NCT01733732|B3|Baseline|Total|Total of all reporting groups
153668|NCT01733732|B2|Baseline|Systane Gel|One drop in each eye 4 times a day for 30 days
153669|NCT01733732|B1|Baseline|Systane Balance|One drop in each eye 4 times a day for 30 days
153670|NCT01733732|P2|Participant Flow|Systane Gel|One drop in each eye 4 times a day for 30 days
153671|NCT01733732|P1|Participant Flow|Systane Balance|One drop in each eye 4 times a day for 30 days
153672|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
153673|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
153674|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
153675|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
153676|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
153677|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
153678|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
153679|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
153680|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
153681|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
153682|NCT01733732|O4|Outcome|Systane Gel, Change From Baseline at Day 30|One drop in each eye 4 times a day for 30 days
153683|NCT01733732|O3|Outcome|Systane Gel, Change From Baseline at Day 14|One drop in each eye 4 times a day for 30 days
153684|NCT01733732|O2|Outcome|Systane Balance, Change From Baseline at Day 30|One drop in each eye 4 times a day for 30 days
153685|NCT01733732|O1|Outcome|Systane Balance, Change From Baseline at Day 14|One drop in each eye 4 times a day for 30 days
153686|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
153687|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
153688|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
153689|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
153690|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
153691|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
153692|NCT01733732|O6|Outcome|Systane Gel, Day 30|One drop in each eye 4 times a day for 30 days
153693|NCT01733732|O5|Outcome|Systane Gel, Day 14|One drop in each eye 4 times a day for 30 days
153694|NCT01733732|O4|Outcome|Systane Gel, Day 0|One drop in each eye 4 times a day for 30 days
153695|NCT01733732|O3|Outcome|Systane Balance, Day 30|One drop in each eye 4 times a day for 30 days
153696|NCT01733732|O2|Outcome|Systane Balance, Day 14|One drop in each eye 4 times a day for 30 days
153697|NCT01733732|O1|Outcome|Systane Balance, Day 0|One drop in each eye 4 times a day for 30 days
153698|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
153699|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
153700|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
153701|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
153702|NCT01733732|E2|Reported Event|Systane Gel|One drop in each eye 4 times a day for 30 days
153703|NCT01733732|E1|Reported Event|Systane Balance|One drop in each eye 4 times a day for 30 days
153704|NCT01733368|B1|Baseline|Quadripolar Left Ventricular Lead (Quartet Lead)|Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead
153705|NCT01733368|P1|Participant Flow|Quadripolar Left Ventricular Lead (Quartet Lead)|Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead
153706|NCT01733368|O1|Outcome|Quadripolar Left Ventricular Lead (Quartet Lead)|Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead
153707|NCT01733368|O1|Outcome|Quadripolar Left Ventricular Lead (Quartet Lead)|Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead
153708|NCT01733368|O2|Outcome|6-Month CRT Non-Responder|Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead and classified as a non-responder at 6 months of follow-up.
153709|NCT01733368|O1|Outcome|6-Month CRT Responder|Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead and classified as a responder at 6 months of follow-up.
153710|NCT01733368|O1|Outcome|Quadripolar Left Ventricular Lead (Quartet Lead)|Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead
153712|NCT01733329|B3|Baseline|Total|Total of all reporting groups
173024|NCT01665170|O1|Outcome|Placebo|Placebo arm
153713|NCT01733329|B2|Baseline|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery assigned randomly to 10 mg Folic acid (2 tablets) (n=60) placed in buccal space after umbilical cord clamping by anesthesiologist . The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Placebo"
153714|NCT01733329|B1|Baseline|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery assigned randomly to 400 mcg misoprostol (2 tablets) (n=60) placed in buccal space after umbilical cord clamping by anesthesiologist. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Misoprostol"
153715|NCT01733329|P2|Participant Flow|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Placebo"
153716|NCT01733329|P1|Participant Flow|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=62) or placebo (n=61) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Misoprostol"
153717|NCT01733329|O2|Outcome|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Placebo"
153718|NCT01733329|O1|Outcome|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Misoprostol"
153719|NCT01733329|O2|Outcome|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Placebo"
153720|NCT01733329|O1|Outcome|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Misoprostol"
153721|NCT01733329|O2|Outcome|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Placebo"
153722|NCT01733329|O1|Outcome|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Misoprostol"
153723|NCT01733329|O2|Outcome|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Placebo"
153724|NCT01733329|O1|Outcome|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Misoprostol"
153725|NCT01733329|E2|Reported Event|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Placebo"
153726|NCT01733329|E1|Reported Event|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Misoprostol"
153727|NCT01733316|B1|Baseline|All Participants|"From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.~During Months 3.5, 4, 5, 6, 7 and for the remainder of study: participants received RP103 Q12H."
153728|NCT01733316|P1|Participant Flow|All Participants|"From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® every 6 hours (Q6H).~During Months 3.5, 4, 5, 6, 7 and for the remainder of study: participants received RP103 every 12 hours (Q12H)."
153729|NCT01733316|O3|Outcome|Long-Term Phase|From Month 7 and for the remainder of study: participants received RP103 Q12H.
153730|NCT01733316|O2|Outcome|RP103 Phase|During Months 3.5, 4, 5, 6, 7: participants received RP103 Q12H.
153731|NCT01733316|O1|Outcome|Cystagon® Phase|From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.
153732|NCT01733316|O3|Outcome|Long-Term Phase|From Month 7 and for the remainder of study: participants received RP103 Q12H.
153733|NCT01733316|O2|Outcome|RP103 Phase|During Months 3.5, 4, 5, 6, 7: participants received RP103 Q12H.
153734|NCT01733316|O1|Outcome|Cystagon® Phase|From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.
153735|NCT01733316|O3|Outcome|Long-Term Phase|From Month 7 and for the remainder of study: participants received RP103 Q12H.
153736|NCT01733316|O2|Outcome|RP103 Phase|During Months 3.5, 4, 5, 6, 7: participants received RP103 Q12H.
153737|NCT01733316|O1|Outcome|Cystagon® Phase|From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.
153738|NCT01733316|O3|Outcome|Long-Term Phase|From Month 7 and for the remainder of study: participants received RP103 Q12H.
153739|NCT01733316|O2|Outcome|RP103 Phase|During Months 3.5, 4, 5, 6, 7: participants received RP103 Q12H.
155555|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
153740|NCT01733316|O1|Outcome|Cystagon® Phase|From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.
153741|NCT01733316|O3|Outcome|Long-Term Phase|From Month 7 and for the remainder of study: participants received RP103 Q12H.
153742|NCT01733316|O2|Outcome|RP103 Phase|During Months 3.5, 4, 5, 6, 7: participants received RP103 Q12H.
153743|NCT01733316|O1|Outcome|Cystagon® Phase|From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.
153744|NCT01733316|O2|Outcome|RP103 Phase|During Months 3.5, 4, 5, 6, 7: participants received RP103 Q12H.
153745|NCT01733316|O1|Outcome|Cystagon® Phase|From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.
153746|NCT01733316|E3|Reported Event|Long-Term Phase|From Month 7 and for the remainder of study: participants received RP103 Q12H.
153747|NCT01733316|E2|Reported Event|RP103 Phase|During Months 3.5, 4, 5, 6, 7: participants received RP103 Q12H.
153748|NCT01733316|E1|Reported Event|Cystagon® Phase|From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.
153749|NCT01733277|B3|Baseline|Total|Total of all reporting groups
153750|NCT01733277|B2|Baseline|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)~MRI"
153751|NCT01733277|B1|Baseline|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)~MRI"
153752|NCT01733277|P2|Participant Flow|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)~MRI"
153753|NCT01733277|P1|Participant Flow|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)~MRI"
153754|NCT01733277|O2|Outcome|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)~MRI"
153755|NCT01733277|O1|Outcome|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)~MRI"
153756|NCT01733277|O2|Outcome|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)~MRI"
153757|NCT01733277|O1|Outcome|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)~MRI"
153758|NCT01733277|O2|Outcome|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)~MRI"
153759|NCT01733277|O1|Outcome|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)~MRI"
153760|NCT01733277|E2|Reported Event|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)~MRI"
153761|NCT01733277|E1|Reported Event|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)~MRI"
153762|NCT01733212|B3|Baseline|Total|Total of all reporting groups
153763|NCT01733212|B2|Baseline|Placebo|2 gm of placebo pill (A capsule)
153764|NCT01733212|B1|Baseline|Ginger|2 gm powder of ginger filled in a capsule
153765|NCT01733212|P2|Participant Flow|Placebo|2 gm of placebo pill (A capsule)
153766|NCT01733212|P1|Participant Flow|Ginger|2 gm powder of ginger filled in a capsule
153767|NCT01733212|O2|Outcome|Placebo|2 gm of placebo pill (A capsule)
153768|NCT01733212|O1|Outcome|Ginger|2 gm powder of ginger filled in a capsule
153769|NCT01733212|E2|Reported Event|Placebo|2 gm of placebo capsule
153770|NCT01733212|E1|Reported Event|Ginger|2 gm powder of ginger filled in a capsule
153771|NCT01733121|B3|Baseline|Total|Total of all reporting groups
153772|NCT01733121|B2|Baseline|Valbenazine|Participants received valbenazine 25mg once daily for 2 weeks, then 50mg once daily for 2 weeks, then 75mg once daily for 2 weeks (a total of 6 weeks).
153773|NCT01733121|B1|Baseline|Placebo|Participants received Placebo capsule (matching valbenazine capsules) daily for 6 weeks.
153774|NCT01733121|P2|Participant Flow|Valbenazine|Participants could receive valbenazine 25mg once daily for 2 weeks, then 50mg once daily for 2 weeks, then 75mg once daily for 2 weeks (a total of 6 weeks); flexible dose escalation.
153775|NCT01733121|P1|Participant Flow|Placebo|Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.
153776|NCT01733121|O2|Outcome|Valbenazine|Participants first received valbenazine 25mg once daily for 2 weeks, then 50mg once daily for 2 weeks, then 75mg once daily for 2 weeks (a total of 6 weeks).
153777|NCT01733121|O1|Outcome|Placebo|Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.
153778|NCT01733121|O2|Outcome|NBI-98854|Participants first received NBI-98854 25mg once daily for 2 weeks, then 50mg once daily for 2 weeks, then 75mg once daily for 2 weeks (a total of 6 weeks).
153779|NCT01733121|O1|Outcome|Placebo|Participants received Placebo capsule (matching NBI-98854 capsules) once daily for 6 weeks.
153780|NCT01733121|O2|Outcome|Valbenazine|Participants first received valbenazine 25mg once daily for 2 weeks, then 50mg once daily for 2 weeks, then 75mg once daily for 2 weeks (a total of 6 weeks).
153781|NCT01733121|O1|Outcome|Placebo|Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.
153782|NCT01733121|O2|Outcome|Valbenazine|Participants first received valbenazine 25mg once daily for 2 weeks, then 50mg once daily for 2 weeks, then 75mg once daily for 2 weeks (a total of 6 weeks).
153783|NCT01733121|O1|Outcome|Placebo|Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.
153784|NCT01733121|E2|Reported Event|Valbenazine|Participants first received valbenazine 5mg once daily for 2 weeks, then 50mg once daily for 2 weeks, then 75mg once daily for 2 weeks (a total of 6 weeks) followed by 2 weeks posttreatment period.
153785|NCT01733121|E1|Reported Event|Placebo|Participants received Placebo capsule (matching valbenazine capsules) daily for 6 weeks followed by 2 weeks posttreatment period.
153786|NCT01733069|B3|Baseline|Total|Total of all reporting groups
153811|NCT01733056|E3|Reported Event|Azathioprine Pre-vaccination|Patients with skin disease treated with azathioprine who had blood drawn prior to vaccination with influenza vaccine
153812|NCT01733056|E2|Reported Event|Healthy Volunteer Post-vaccination|Healthy volunteers who had blood drawn after vaccination with influenza vaccine
155556|NCT01727141|O4|Outcome|Placebo|b.i.d
153787|NCT01733069|B2|Baseline|Negative Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses
153788|NCT01733069|B1|Baseline|Positive Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses
153789|NCT01733069|P2|Participant Flow|Negative Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses
153790|NCT01733069|P1|Participant Flow|Positive Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses.
153791|NCT01733069|O2|Outcome|Negative Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses
153792|NCT01733069|O1|Outcome|Positive Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses
153793|NCT01733069|E2|Reported Event|Negative Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorized as infected or non-infected were excluded from the performance analyses
153794|NCT01733069|E1|Reported Event|Positive Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorized as infected or non-infected were excluded from the performance analyses
153795|NCT01733056|B4|Baseline|Total|Total of all reporting groups
153796|NCT01733056|B3|Baseline|TNF Alpha Blocker|Patients with skin diseases taking TNF alpha blockers
153797|NCT01733056|B2|Baseline|Azathioprine|Patients with skin diseases taking azathioprine
153798|NCT01733056|B1|Baseline|Healthy Volunteer|Healthy volunteers without skin disease prior to influenza vaccination
153799|NCT01733056|P3|Participant Flow|TNF Alpha Blockers|
153800|NCT01733056|P2|Participant Flow|Azathioprine|
153801|NCT01733056|P1|Participant Flow|Healthy Volunteer|
153802|NCT01733056|O3|Outcome|TNF Alpha Blockers|Patients with skin diseases taking TNF alpha blockers
153803|NCT01733056|O2|Outcome|Azathioprine|Patients with skin diseases taking azathioprine
153804|NCT01733056|O1|Outcome|Healthy Volunteer|Healthy volunteers without skin disease prior to influenza vaccination
153805|NCT01733056|O3|Outcome|TNF Alpha Blockers|Patients with skin diseases taking TNF alpha blockers
153806|NCT01733056|O2|Outcome|Azathioprine|Patients with skin diseases taking azathioprine
153807|NCT01733056|O1|Outcome|Healthy Volunteer|Healthy volunteers without skin disease prior to influenza vaccination
153808|NCT01733056|E6|Reported Event|TNF Alpha Blocker Post-vaccination|Patients with skin disease treated with TNF blockers who had blood drawn after vaccination with influenza vaccine
153809|NCT01733056|E5|Reported Event|TNF Alpha Blocker Pre-vaccination|Patients with skin disease treated with TNF blockers who had blood drawn prior to vaccination with influenza vaccine
153810|NCT01733056|E4|Reported Event|Azathioprine Post-vaccination|Patients with skin disease treated with azathioprine who had blood drawn after vaccination with influenza vaccine
153813|NCT01733056|E1|Reported Event|Healthy Volunteer Pre-vaccination|Healthy volunteers who had blood drawn prior to vaccination with influenza vaccine
153814|NCT01732926|B3|Baseline|Total|Total of all reporting groups
153815|NCT01732926|B2|Baseline|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
153816|NCT01732926|B1|Baseline|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
153817|NCT01732926|P2|Participant Flow|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
153818|NCT01732926|P1|Participant Flow|Idelalisib + Bendamustine + Rituximab|"Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions)~+ rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)"
153819|NCT01732926|O2|Outcome|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
153820|NCT01732926|O1|Outcome|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
153821|NCT01732926|O2|Outcome|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
153822|NCT01732926|O1|Outcome|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
153823|NCT01732926|O2|Outcome|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
153824|NCT01732926|O1|Outcome|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
153825|NCT01732926|O2|Outcome|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
153826|NCT01732926|O1|Outcome|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
153827|NCT01732926|O2|Outcome|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
153828|NCT01732926|O1|Outcome|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
153829|NCT01732926|E2|Reported Event|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
153830|NCT01732926|E1|Reported Event|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
153831|NCT01732913|B3|Baseline|Total|Total of all reporting groups
153832|NCT01732913|B2|Baseline|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
153833|NCT01732913|B1|Baseline|Idelalisib + Rituximab|Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
153834|NCT01732913|P2|Participant Flow|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
153835|NCT01732913|P1|Participant Flow|Idelalisib + Rituximab|Idelalisib (Zydelig®) 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
153836|NCT01732913|O2|Outcome|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
153837|NCT01732913|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
153838|NCT01732913|O2|Outcome|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
153839|NCT01732913|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
153840|NCT01732913|O2|Outcome|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
153841|NCT01732913|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
153842|NCT01732913|O2|Outcome|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
153843|NCT01732913|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
153844|NCT01732913|O2|Outcome|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
153845|NCT01732913|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
153846|NCT01732913|E2|Reported Event|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
153847|NCT01732913|E1|Reported Event|Idelalisib + Rituximab|Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
153848|NCT01732835|B1|Baseline|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153849|NCT01732835|P1|Participant Flow|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153850|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153851|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153852|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153853|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153854|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153855|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153856|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153857|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153858|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153859|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153860|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153861|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153862|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153863|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153864|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153865|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153866|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153867|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153868|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153869|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153870|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153871|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153872|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153873|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153874|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153875|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153876|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
154030|NCT01732757|E1|Reported Event|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
153877|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153878|NCT01732835|E1|Reported Event|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
153879|NCT01732822|B3|Baseline|Total|Total of all reporting groups
153880|NCT01732822|B2|Baseline|Clopidogrel 75mg od|
153881|NCT01732822|B1|Baseline|Ticagrelor 90mg bd|
153882|NCT01732822|P2|Participant Flow|Clopidogrel 75 mg od|
153883|NCT01732822|P1|Participant Flow|Ticagrelor 90 mg bd|
153884|NCT01732822|O2|Outcome|Clopidogrel 75 mg od|
153885|NCT01732822|O1|Outcome|Ticagrelor 90 mg bd|
153886|NCT01732822|O2|Outcome|Clopidogrel 75 mg od|
153887|NCT01732822|O1|Outcome|Ticagrelor 90 mg bd|
153888|NCT01732822|O2|Outcome|Clopidogrel 75 mg od|
153889|NCT01732822|O1|Outcome|Ticagrelor 90 mg bd|
153890|NCT01732822|O2|Outcome|Clopidogrel 75 mg od|
153891|NCT01732822|O1|Outcome|Ticagrelor 90 mg bd|
153892|NCT01732822|O2|Outcome|Clopidogrel 75 mg od|
153893|NCT01732822|O1|Outcome|Ticagrelor 90 mg bd|
153894|NCT01732822|O2|Outcome|Clopidogrel 75 mg od|
153895|NCT01732822|O1|Outcome|Ticagrelor 90 mg bd|
153896|NCT01732822|O2|Outcome|Clopidogrel 75 mg od|
153897|NCT01732822|O1|Outcome|Ticagrelor 90 mg bd|
153898|NCT01732822|O2|Outcome|Clopidogrel 75 mg od|
153899|NCT01732822|O1|Outcome|Ticagrelor 90 mg bd|
153900|NCT01732822|O12|Outcome|Clopidogrel - Cat 6|Baseline Rutherford category 6
153901|NCT01732822|O11|Outcome|Clopidogrel - Cat 5|Baseline Rutherford category 5
153902|NCT01732822|O10|Outcome|Clopidogrel - Cat 4|Baseline Rutherford category 4
153903|NCT01732822|O9|Outcome|Clopidogrel - Cat 3|Baseline Rutherford category 3
153904|NCT01732822|O8|Outcome|Clopidogrel - Cat 1/2|Baseline Rutherford category 1/2
153905|NCT01732822|O7|Outcome|Clopidogrel - Cat 0|Baseline Rutherford category 0
153906|NCT01732822|O6|Outcome|Ticagrelor - Cat 6|Baseline Rutherford category 6
153907|NCT01732822|O5|Outcome|Ticagrelor - Cat 5|Baseline Rutherford category 5
153908|NCT01732822|O4|Outcome|Ticagrelor - Cat 4|Baseline Rutherford category 4
153909|NCT01732822|O3|Outcome|Ticagrelor - Cat 3|Baseline Rutherford category 3
153910|NCT01732822|O2|Outcome|Ticagrelor - Stage II|Baseline Rutherford category 1/2
153911|NCT01732822|O1|Outcome|Ticagrelor - Cat 0|Baseline Rutherford category 0
153912|NCT01732822|O10|Outcome|Clopidogrel - Stage IV|Baseline Fontaine stage IV
153913|NCT01732822|O9|Outcome|Clopidogrel - Stage III|Baseline Fontaine stage III
153914|NCT01732822|O8|Outcome|Clopidogrel - Stage IIb|Baseline Fontaine stage IIb
153915|NCT01732822|O7|Outcome|Clopidogrel - Stage IIa|Baseline Fontaine stage IIa
153916|NCT01732822|O6|Outcome|Clopidogrel - Stage I|Baseline Fontaine stage I
153917|NCT01732822|O5|Outcome|Ticagrelor - Stage IV|Baseline Fontaine stage IV
153918|NCT01732822|O4|Outcome|Ticagrelor - Stage III|Baseline Fontaine stage III
153919|NCT01732822|O3|Outcome|Ticagrelor - Stage IIb|Baseline Fontaine stage IIb
153920|NCT01732822|O2|Outcome|Ticagrelor - Stage IIa|Baseline Fontaine stage IIa
153921|NCT01732822|O1|Outcome|Ticagrelor - Stage I|Baseline Fontaine stage I
153922|NCT01732822|O2|Outcome|Clopidogrel 75 mg od|
153923|NCT01732822|O1|Outcome|Ticagrelor 90 mg bd|
153924|NCT01732822|O2|Outcome|Clopidogrel 75 mg od|
153925|NCT01732822|O1|Outcome|Ticagrelor 90 mg bd|
153926|NCT01732822|O2|Outcome|Clopidogrel 75 mg od|
153927|NCT01732822|O1|Outcome|Ticagrelor 90 mg bd|
153928|NCT01732822|O2|Outcome|Clopidogrel 75 mg od|
153929|NCT01732822|O1|Outcome|Ticagrelor 90 mg bd|
153930|NCT01732822|O2|Outcome|Clopidogrel 75 mg od|
153931|NCT01732822|O1|Outcome|Ticagrelor 90 mg bd|
153932|NCT01732822|O2|Outcome|Clopidogrel 75 mg od|
153933|NCT01732822|O1|Outcome|Ticagrelor 90 mg bd|
153934|NCT01732822|O2|Outcome|Clopidogrel 75 mg od|
153935|NCT01732822|O1|Outcome|Ticagrelor 90 mg bd|
153936|NCT01732822|O2|Outcome|Clopidogrel 75 mg od|
153937|NCT01732822|O1|Outcome|Ticagrelor 90 mg bd|
153938|NCT01732822|O2|Outcome|Clopidogrel 75 mg od|
153939|NCT01732822|O1|Outcome|Ticagrelor 90 mg bd|
153940|NCT01732822|O2|Outcome|Clopidogrel 75 mg od|
153941|NCT01732822|O1|Outcome|Ticagrelor 90 mg bd|
153942|NCT01732822|O2|Outcome|Clopidogrel 75 mg od|
153943|NCT01732822|O1|Outcome|Ticagrelor 90 mg bd|
153944|NCT01732822|O2|Outcome|Clopidogrel 75 mg od|
153945|NCT01732822|O1|Outcome|Ticagrelor 90 mg bd|
153946|NCT01732822|O2|Outcome|Clopidogrel 75 mg od|
153947|NCT01732822|O1|Outcome|Ticagrelor 90 mg bd|
153948|NCT01732822|O2|Outcome|Clopidogrel 75 mg od|
153949|NCT01732822|O1|Outcome|Ticagrelor 90 mg bd|
153950|NCT01732822|E2|Reported Event|Ticagrelor 90mg bd|
153951|NCT01732822|E1|Reported Event|Clopidogrel 75mg od|
153952|NCT01732796|B4|Baseline|Total|Total of all reporting groups
153953|NCT01732796|B3|Baseline|24 wk CR FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
153954|NCT01732796|B2|Baseline|24 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
153955|NCT01732796|B1|Baseline|16 wk NC FDV+DBV+RBV|"600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally).~This group included non-cirrhotic patients (NC)."
154031|NCT01732692|B3|Baseline|Total|Total of all reporting groups
153956|NCT01732796|P3|Participant Flow|24 wk CR FDV+DBV+RBV|600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin (RBV) BID for 24 weeks (wk). All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
153957|NCT01732796|P2|Participant Flow|24 wk NC FDV+DBV+RBV|"600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin (RBV) BID for 24 weeks (wk). All were administered per os (orally).~This group included non-cirrhotic patients (NC)."
153958|NCT01732796|P1|Participant Flow|16 wk NC FDV+DBV+RBV|"600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin BID (RBV) for 16 weeks (wk) followed by DBV placebo, FDV placebo and RBV placebo for 8 weeks. All were administered per os (orally).~This group included non-cirrhotic patients (NC)."
153959|NCT01732796|O3|Outcome|24 wk CR FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
153960|NCT01732796|O2|Outcome|24 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
153961|NCT01732796|O1|Outcome|16 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
153962|NCT01732796|O3|Outcome|24 wk CR FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
153963|NCT01732796|O2|Outcome|24 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
153964|NCT01732796|O1|Outcome|16 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
153965|NCT01732796|O3|Outcome|24 wk CR FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
153966|NCT01732796|O2|Outcome|24 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
153967|NCT01732796|O1|Outcome|16 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
153968|NCT01732796|O2|Outcome|16 wk FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID), orally. This is the combination of non-cirrhotic patients in the 16 week treatment group and cirrhosis patients in the 24-week treatment group.
153969|NCT01732796|O1|Outcome|24 wk FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk (orally) in cirrhotic and non-cirrhotic patients.
153970|NCT01732796|E3|Reported Event|24 wk CR FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
153971|NCT01732796|E2|Reported Event|24 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
153972|NCT01732796|E1|Reported Event|16 wk NC FDV+DBV+RBV|"600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally).~This group included non-cirrhotic patients (NC)."
153973|NCT01732770|B3|Baseline|Total|Total of all reporting groups
153974|NCT01732770|B2|Baseline|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
153975|NCT01732770|B1|Baseline|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
153976|NCT01732770|P2|Participant Flow|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
153977|NCT01732770|P1|Participant Flow|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
153978|NCT01732770|O2|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
153979|NCT01732770|O1|Outcome|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
153980|NCT01732770|O2|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
153981|NCT01732770|O1|Outcome|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
153982|NCT01732770|O2|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
153983|NCT01732770|O1|Outcome|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
153984|NCT01732770|O2|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
155557|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
153985|NCT01732770|O1|Outcome|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
153986|NCT01732770|E2|Reported Event|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
153987|NCT01732770|E1|Reported Event|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
153988|NCT01732757|B4|Baseline|Total|Total of all reporting groups
153989|NCT01732757|B3|Baseline|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
153990|NCT01732757|B2|Baseline|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
153991|NCT01732757|B1|Baseline|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
153992|NCT01732757|P3|Participant Flow|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
153993|NCT01732757|P2|Participant Flow|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
153994|NCT01732757|P1|Participant Flow|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
153995|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
153996|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
153997|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
153998|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
153999|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
154000|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
154001|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
154002|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
154003|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
154004|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
154005|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
154006|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
154007|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
154008|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
154009|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
154010|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
154011|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
154012|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
154013|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
154014|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
154015|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
154016|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
154017|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
154018|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
154019|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
154020|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
154021|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
154022|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
154023|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
154024|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
154025|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
154026|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
154027|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
154028|NCT01732757|E3|Reported Event|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
154029|NCT01732757|E2|Reported Event|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
154032|NCT01732692|B2|Baseline|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
154033|NCT01732692|B1|Baseline|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
154034|NCT01732692|P2|Participant Flow|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
154035|NCT01732692|P1|Participant Flow|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
154036|NCT01732692|O2|Outcome|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
154037|NCT01732692|O1|Outcome|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
154038|NCT01732692|O2|Outcome|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
154039|NCT01732692|O1|Outcome|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
154040|NCT01732692|O2|Outcome|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
154041|NCT01732692|O1|Outcome|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
154042|NCT01732692|O2|Outcome|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
154043|NCT01732692|O1|Outcome|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
154044|NCT01732692|O2|Outcome|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
154045|NCT01732692|O1|Outcome|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
154046|NCT01732692|E2|Reported Event|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
154047|NCT01732692|E1|Reported Event|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
154048|NCT01732588|B4|Baseline|Total|Total of all reporting groups
154049|NCT01732588|B3|Baseline|Sequence 3|Subjects received a single dose of 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C); then 120 mg OZ439 PIB oral suspension (Regimen A); then 120 mg OZ439 IR caplet (Regimen B).
154050|NCT01732588|B2|Baseline|Sequence 2|Subjects received a single dose of 120 mg OZ439 IR caplet (Regimen B); then 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C); then 120 mg OZ439 PIB oral suspension (Regimen A)
154051|NCT01732588|B1|Baseline|Sequence 1|Subjects received a single dose of 120 mg OZ439 PIB oral suspension (Regimen A), then 120 mg OZ439 IR caplet (Regimen B); then 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C)
154052|NCT01732588|P3|Participant Flow|Sequence 3|Subjects received a single dose of 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C); then 120 mg OZ439 PIB oral suspension (Regimen A); then 120 mg OZ439 IR caplet (Regimen B).
154053|NCT01732588|P2|Participant Flow|Sequence 2|Subjects received a single dose of 120 mg OZ439 IR caplet (Regimen B); then 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C); then 120 mg OZ439 PIB oral suspension (Regimen A).
154054|NCT01732588|P1|Participant Flow|Sequence 1|Subjects received a single dose of 120 mg OZ439 PIB oral suspension (Regimen A), then 120 mg OZ439 IR caplet (Regimen B); then 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C)
154055|NCT01732588|O3|Outcome|Regimen C - 120 mg OZ439 Caplet Via Enterion Capsule|Single dose of 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule
154056|NCT01732588|O2|Outcome|Regimen B - 120 mg OZ439 IR Caplet|Single dose of 120 mg OZ439 Immediate release (IR) caplet formulation containing nanoparticulate
154057|NCT01732588|O1|Outcome|Regimen A - OZ439 120mg PIB|Single dose of 120 mg OZ439 powder in bottle (PIB) oral suspension
154058|NCT01732588|O3|Outcome|Regimen C - 120 mg OZ439 Caplet Via Enterion Capsule|Single dose of 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule
154059|NCT01732588|O2|Outcome|Regimen B - 120 mg OZ439 IR Caplet|Single dose of 120 mg OZ439 Immediate release (IR) caplet formulation containing nanoparticulate
154060|NCT01732588|O1|Outcome|Regimen A - OZ439 120mg PIB|Single dose of 120 mg OZ439 powder in bottle (PIB) oral suspension
154061|NCT01732588|O3|Outcome|Regimen C - 120 mg OZ439 Caplet Via Enterion Capsule|Single dose of 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule
154062|NCT01732588|O2|Outcome|Regimen B - 120 mg OZ439 IR Caplet|Single dose of 120 mg OZ439 Immediate release (IR) caplet formulation containing nanoparticulate
154063|NCT01732588|O1|Outcome|Regimen A - OZ439 120mg PIB|Single dose of 120 mg OZ439 powder in bottle (PIB) oral suspension
154064|NCT01732588|E3|Reported Event|Regimen C - 120 mg OZ439 Caplet Via Enterion Capsule|Single dose of 120 mg OZ439 caplet formulation containing nanoparticulate administered orally via the Enterion capsule
154065|NCT01732588|E2|Reported Event|Regimen B - 120 mg OZ439 IR Caplet|Single oral dose of 120 mg OZ439 Immediate release (IR) caplet formulation containing nanoparticulate
154068|NCT01732549|B2|Baseline|Placebo|"1 capsule daily, taken orally with water and food until disease progression~Placebo: Patients received Placebo capsules (identical to tasquinimod capsules) to be taken orally once a day with water and food"
154069|NCT01732549|B1|Baseline|Tasquinimod|"1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.~Tasquinimod: Patients received initially an oral dose of 0.25 mg/day of tasquinimod, starting on Day 1, for at least 2 weeks. Once tolerability of the 0.25 mg/day dose was established, patients received a dose increase to 0.5 mg/day for at least 2 weeks, and then increased to 1 mg/day of study treatment. Patients showing poor tolerability for the escalated doses of tasquinimod were allowed to continue study treatment at the highest individually tolerated dose"
154070|NCT01732549|P2|Participant Flow|Placebo|"1 capsule daily, taken orally with water and food until disease progression~Placebo: Patients received Placebo capsules (identical to tasquinimod capsules) to be taken orally once a day with water and food"
154071|NCT01732549|P1|Participant Flow|Tasquinimod|"1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.~Tasquinimod: Patients received initially an oral dose of 0.25 mg/day of tasquinimod, starting on Day 1, for at least 2 weeks. Once tolerability of the 0.25 mg/day dose was established, patients received a dose increase to 0.5 mg/day for at least 2 weeks, and then increased to 1 mg/day of study treatment. Patients showing poor tolerability for the escalated doses of tasquinimod were allowed to continue study treatment at the highest individually tolerated dose"
154072|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
154073|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
154074|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
154075|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
154076|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
154077|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
154078|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
154079|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
154080|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
154081|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
154082|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
154083|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression
154084|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
154085|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression
154086|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
154087|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
154088|NCT01732549|E2|Reported Event|Placebo|"1 capsule daily, taken orally with water and food until disease progression~Placebo: Patients received Placebo capsules (identical to tasquinimod capsules) to be taken orally once a day with water and food"
154089|NCT01732549|E1|Reported Event|Tasquinimod|"1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.~Tasquinimod: Patients received initially an oral dose of 0.25 mg/day of tasquinimod, starting on Day 1, for at least 2 weeks. Once tolerability of the 0.25 mg/day dose was established, patients received a dose increase to 0.5 mg/day for at least 2 weeks, and then increased to 1 mg/day of study treatment. Patients showing poor tolerability for the escalated doses of tasquinimod were allowed to continue study treatment at the highest individually tolerated dose"
154090|NCT01732510|B8|Baseline|Total|Total of all reporting groups
154091|NCT01732510|B7|Baseline|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
154092|NCT01732510|B6|Baseline|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154093|NCT01732510|B5|Baseline|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
154094|NCT01732510|B4|Baseline|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154095|NCT01732510|B3|Baseline|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154096|NCT01732510|B2|Baseline|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154097|NCT01732510|B1|Baseline|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
154098|NCT01732510|P7|Participant Flow|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
154099|NCT01732510|P6|Participant Flow|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154100|NCT01732510|P5|Participant Flow|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
154101|NCT01732510|P4|Participant Flow|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154102|NCT01732510|P3|Participant Flow|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
155558|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
154103|NCT01732510|P2|Participant Flow|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154104|NCT01732510|P1|Participant Flow|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
154105|NCT01732510|O7|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
154106|NCT01732510|O6|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154107|NCT01732510|O5|Outcome|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks. No participant met criteria for inclusion in the evaluable population.
154108|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154109|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154110|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154111|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
154112|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
154113|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154114|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
154115|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154116|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
154117|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154118|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
154119|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154120|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
154121|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154122|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
154123|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154124|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
154125|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154126|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
154127|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154128|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154129|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154130|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154131|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
154132|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154133|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154134|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154135|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
154136|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154137|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154138|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154139|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
154140|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154141|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154142|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154143|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
154144|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154145|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154146|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154147|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
154148|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154149|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154150|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154151|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
154152|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
154153|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154154|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
154155|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154156|NCT01732510|O5|Outcome|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
154157|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154158|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154159|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154160|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
154161|NCT01732510|O7|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
154162|NCT01732510|O6|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154163|NCT01732510|O5|Outcome|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
154164|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154165|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154166|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154167|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
154168|NCT01732510|O7|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
154169|NCT01732510|O6|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154170|NCT01732510|O5|Outcome|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
154171|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154172|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154173|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154174|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
154175|NCT01732510|E7|Reported Event|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
154176|NCT01732510|E6|Reported Event|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154177|NCT01732510|E5|Reported Event|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
154178|NCT01732510|E4|Reported Event|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154179|NCT01732510|E3|Reported Event|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154180|NCT01732510|E2|Reported Event|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154181|NCT01732510|E1|Reported Event|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
154182|NCT01732484|B1|Baseline|Cataract Surgery|eyes with implantation of iMics1 NY-60 IOL or Acrysof SN60WF IOL
154183|NCT01732484|P1|Participant Flow|Patients Included|
154184|NCT01732484|O2|Outcome|AcrySof SN60WF|eyes with implantation of AcrySof SN60WF IOL
154185|NCT01732484|O1|Outcome|iMics1 NY-60|eyes with implantation of iMics1 NY-60 IOL
154186|NCT01732484|O2|Outcome|AcrySof SN60WF|eyes with implantation of AcrySof SN60WF IOL
154187|NCT01732484|O1|Outcome|iMics1 NY-60|eyes with implantation of iMics1 NY-60 IOL
154188|NCT01732484|E2|Reported Event|AcrySof SN60WF|eyes with implantation of AcrySof SN60WF IOL
154189|NCT01732484|E1|Reported Event|iMics1 NY-60|eyes with implantation of iMics1 NY-60 IOL
154190|NCT01732471|B1|Baseline|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
154191|NCT01732471|P1|Participant Flow|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 milligram per kilogram per day (mg/kg/day) once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
154192|NCT01732471|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
154193|NCT01732471|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
154194|NCT01732471|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
155097|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
154195|NCT01732471|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
154196|NCT01732471|E1|Reported Event|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
154197|NCT01732458|B5|Baseline|Total|Total of all reporting groups
154198|NCT01732458|B4|Baseline|Ondansetron|Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.
154199|NCT01732458|B3|Baseline|Aprepitant Dose 3: Equivalent to 10 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
154200|NCT01732458|B2|Baseline|Aprepitant Dose 2: Equivalent to 40 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
154201|NCT01732458|B1|Baseline|Aprepitant Dose 1: Equivalent to 125 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered intravenously (IV) immediately prior to anesthesia.
154202|NCT01732458|P4|Participant Flow|Ondansetron|Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.
154203|NCT01732458|P3|Participant Flow|Aprepitant Dose 3: Equivalent to 10 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
154204|NCT01732458|P2|Participant Flow|Aprepitant Dose 2: Equivalent to 40 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
154205|NCT01732458|P1|Participant Flow|Aprepitant Dose 1: Equivalent to 125 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered intravenously (IV) immediately prior to anesthesia.
154206|NCT01732458|O4|Outcome|Ondansetron|Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
154207|NCT01732458|O3|Outcome|Aprepitant Dose 3: Equivalent to 10 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
154208|NCT01732458|O2|Outcome|Aprepitant Dose 2: Equivalent to 40 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
154209|NCT01732458|O1|Outcome|Aprepitant Dose 1: Equivalent to 125 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
154210|NCT01732458|O4|Outcome|Ondansetron|Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
154211|NCT01732458|O3|Outcome|Aprepitant Dose 3: Equivalent to 10 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
154212|NCT01732458|O2|Outcome|Aprepitant Dose 2: Equivalent to 40 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
154213|NCT01732458|O1|Outcome|Aprepitant Dose 1: Equivalent to 125 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
154214|NCT01732458|O4|Outcome|Ondansetron|Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
154215|NCT01732458|O3|Outcome|Aprepitant Dose 3: Equivalent to 10 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
154216|NCT01732458|O2|Outcome|Aprepitant Dose 2: Equivalent to 40 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
154217|NCT01732458|O1|Outcome|Aprepitant Dose 1: Equivalent to 125 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
162016|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
154218|NCT01732458|O4|Outcome|Ondansetron|Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
154219|NCT01732458|O3|Outcome|Aprepitant Dose 3: Equivalent to 10 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
154220|NCT01732458|O2|Outcome|Aprepitant Dose 2: Equivalent to 40 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
154221|NCT01732458|O1|Outcome|Aprepitant Dose 1: Equivalent to 125 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
154222|NCT01732458|O4|Outcome|Ondansetron|Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
154223|NCT01732458|O3|Outcome|Aprepitant Dose 3: Equivalent to 10 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
154224|NCT01732458|O2|Outcome|Aprepitant Dose 2: Equivalent to 40 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
154225|NCT01732458|O1|Outcome|Aprepitant Dose 1: Equivalent to 125 mg in Adults|Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
154226|NCT01732458|O1|Outcome|Aprepitant Dose 3: Equivalent to 10 mg in Adults; Birth to <2|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to <2 years old.
154227|NCT01732458|O1|Outcome|Aprepitant Dose 3: Equivalent to 10 mg in Adults; Birth to <2|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to <2 years old.
154228|NCT01732458|O1|Outcome|Aprepitant Dose 3: Equivalent to 10 mg in Adults; Birth to <2|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to <2 years old.
154229|NCT01732458|O1|Outcome|Aprepitant Dose 3: Equivalent to 10 mg in Adults; 2 to <6|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to <6 years old.
154230|NCT01732458|O1|Outcome|Aprepitant Dose 3: Equivalent to 10 mg in Adults; 2 to <6|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to <6 years old.
154231|NCT01732458|O1|Outcome|Aprepitant Dose 3: Equivalent to 10 mg in Adults; 2 to <6|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to <6 years old.
154232|NCT01732458|O1|Outcome|Aprepitant Dose 3: Equivalent to 10 mg in Adults; 6 to <12|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to <12 years old.
154233|NCT01732458|O1|Outcome|Aprepitant Dose 3: Equivalent to 10 mg in Adults; 6 to <12|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to <12 years old.
154234|NCT01732458|O1|Outcome|Aprepitant Dose 3: Equivalent to 10 mg in Adults; 6 to <12|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to <12 years old.
154235|NCT01732458|O1|Outcome|Aprepitant Dose 3: Equivalent to 10 mg in Adults; 12 to 17|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.
154236|NCT01732458|O1|Outcome|Aprepitant Dose 3: Equivalent to 10 mg in Adults; 12 to 17|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.
154237|NCT01732458|O1|Outcome|Aprepitant Dose 3: Equivalent to 10 mg in Adults; 12 to 17|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.
154238|NCT01732458|O1|Outcome|Aprepitant Dose 2: Equivalent to 40 mg in Adults; Birth to <2|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to <2 years old.
154239|NCT01732458|O1|Outcome|Aprepitant Dose 2: Equivalent to 40 mg in Adults; Birth to <2|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to <2 years old.
154240|NCT01732458|O1|Outcome|Aprepitant Dose 2: Equivalent to 40 mg in Adults; Birth to <2|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to <2 years old.
154241|NCT01732458|O1|Outcome|Aprepitant Dose 2: Equivalent to 40 mg in Adults; 2 to <6|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to <6 years old.
154242|NCT01732458|O1|Outcome|Aprepitant Dose 2: Equivalent to 40 mg in Adults; 2 to <6|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to <6 years old.
154243|NCT01732458|O1|Outcome|Aprepitant Dose 2: Equivalent to 40 mg in Adults; 2 to <6|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to <6 years old.
154244|NCT01732458|O1|Outcome|Aprepitant Dose 2: Equivalent to 40 mg in Adults; 6 to <12|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to <12 years old.
154245|NCT01732458|O1|Outcome|Aprepitant Dose 2: Equivalent to 40 mg in Adults; 6 to <12|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to <12 years old.
154246|NCT01732458|O1|Outcome|Aprepitant Dose 2: Equivalent to 40 mg in Adults; 6 to <12|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to <12 years old.
154247|NCT01732458|O1|Outcome|Aprepitant Dose 2: Equivalent to 40 mg in Adults; 12 to 17|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.
154248|NCT01732458|O1|Outcome|Aprepitant Dose 2: Equivalent to 40 mg in Adults; 12 to 17|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.
154249|NCT01732458|O1|Outcome|Aprepitant Dose 2: Equivalent to 40 mg in Adults; 12 to 17|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.
154250|NCT01732458|O1|Outcome|Aprepitant Dose 1: Equivalent to 125 mg in Adults; Birth to <2|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to <2 years old.
154251|NCT01732458|O1|Outcome|Aprepitant Dose 1: Equivalent to 125 mg in Adults; Birth to <2|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to <2 years old.
154252|NCT01732458|O1|Outcome|Aprepitant Dose 1: Equivalent to 125 mg in Adults; Birth to <2|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to <2 years old.
154253|NCT01732458|O1|Outcome|Aprepitant Dose 1: Equivalent to 125 mg in Adults; 2 to <6|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to <6 years old.
154254|NCT01732458|O1|Outcome|Aprepitant Dose 1: Equivalent to 125 mg in Adults; 2 to <6|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to <6 years old.
154255|NCT01732458|O1|Outcome|Aprepitant Dose 1: Equivalent to 125 mg in Adults; 2 to <6|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to <6 years old.
154256|NCT01732458|O1|Outcome|Aprepitant Dose 1: Equivalent to 125 mg in Adults; 6 to <12|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to <12 years old.
154257|NCT01732458|O1|Outcome|Aprepitant Dose 1: Equivalent to 125 mg in Adults; 6 to <12|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to <12 years old.
154258|NCT01732458|O1|Outcome|Aprepitant Dose 1: Equivalent to 125 mg in Adults; 6 to <12|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to <12 years old.
154259|NCT01732458|O1|Outcome|Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.
154260|NCT01732458|O1|Outcome|Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.
154261|NCT01732458|O1|Outcome|Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17|Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.
154262|NCT01732458|E4|Reported Event|Ondansetron|Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.
154263|NCT01732458|E3|Reported Event|Aprepitant 10 mg Adult Equivalent (Dose 3)|Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
154264|NCT01732458|E2|Reported Event|Aprepitant 40 mg Adult Equivalent (Dose 2)|Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
154265|NCT01732458|E1|Reported Event|Aprepitant 125 mg Adult Equivalent (Dose 1)|Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.
154266|NCT01732445|B1|Baseline|Supportive Care (Ruxolitinib Phosphate and Danazol)|Patients receive ruxolitinib phosphate PO 10 mg BID and danazol PO 200 mg TID on days 1-56. Treatment repeats every 56 days for 6 courses in the absence of disease progression or unacceptable toxicity. At the treating physician’s discretion, patients may continue treatment past 6 courses if they are without disease progression.
154267|NCT01732445|P1|Participant Flow|Supportive Care (Ruxolitinib Phosphate and Danazol)|Patients receive ruxolitinib phosphate PO 10 mg BID and danazol PO 200 mg TID on days 1-56. Treatment repeats every 56 days for 6 courses in the absence of disease progression or unacceptable toxicity. At the treating physician’s discretion, patients may continue treatment past 6 courses if they are without disease progression.
154268|NCT01732445|O1|Outcome|Supportive Care (Ruxolitinib Phosphate and Danazol)|Patients receive ruxolitinib phosphate PO 10 mg BID and danazol PO 200 mg TID on days 1-56. Treatment repeats every 56 days for 6 courses in the absence of disease progression or unacceptable toxicity. At the treating physician’s discretion, patients may continue treatment past 6 courses if they are without disease progression.
154269|NCT01732445|O1|Outcome|Supportive Care (Ruxolitinib Phosphate and Danazol)|Patients receive ruxolitinib phosphate PO 10 mg BID and danazol PO 200 mg TID on days 1-56. Treatment repeats every 56 days for 6 courses in the absence of disease progression or unacceptable toxicity. At the treating physician’s discretion, patients may continue treatment past 6 courses if they are without disease progression.
154270|NCT01732445|O1|Outcome|Supportive Care (Ruxolitinib Phosphate and Danazol)|Patients receive ruxolitinib phosphate PO 10 mg BID and danazol PO 200 mg TID on days 1-56. Treatment repeats every 56 days for 6 courses in the absence of disease progression or unacceptable toxicity. At the treating physician’s discretion, patients may continue treatment past 6 courses if they are without disease progression.
154271|NCT01732445|O1|Outcome|Supportive Care (Ruxolitinib Phosphate and Danazol)|Patients receive ruxolitinib phosphate PO 10 mg BID and danazol PO 200 mg TID on days 1-56. Treatment repeats every 56 days for 6 courses in the absence of disease progression or unacceptable toxicity. At the treating physician’s discretion, patients may continue treatment past 6 courses if they are without disease progression.
154272|NCT01732445|E1|Reported Event|Supportive Care (Ruxolitinib Phosphate and Danazol)|Patients receive ruxolitinib phosphate PO 10 mg BID and danazol PO 200 mg TID on days 1-56. Treatment repeats every 56 days for 6 courses in the absence of disease progression or unacceptable toxicity. At the treating physician’s discretion, patients may continue treatment past 6 courses if they are without disease progression.
154273|NCT01732263|B3|Baseline|Total|Total of all reporting groups
154274|NCT01732263|B2|Baseline|Matched Healthy Subjects|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
154275|NCT01732263|B1|Baseline|Hepatic Impairment|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
154276|NCT01732263|P2|Participant Flow|Matched Healthy Subjects|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
154277|NCT01732263|P1|Participant Flow|Hepatic Impairment|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
154278|NCT01732263|O6|Outcome|SSP-004184 (Matched Healthy Subjects) 50 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
154279|NCT01732263|O5|Outcome|SSP-004184 (Matched Healthy Subjects) 45 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
154280|NCT01732263|O4|Outcome|SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
154281|NCT01732263|O3|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
154282|NCT01732263|O2|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
154342|NCT01731938|O2|Outcome|Surgicel®|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.~Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
154389|NCT01730846|B3|Baseline|8mg/Day|"doxazosin 8mg/day~Doxazosin: 8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study."
154283|NCT01732263|O1|Outcome|SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
154284|NCT01732263|O6|Outcome|SSP-004184 (Matched Healthy Subjects) 50 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
154285|NCT01732263|O5|Outcome|SSP-004184 (Matched Healthy Subjects) 45 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
154286|NCT01732263|O4|Outcome|SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
154287|NCT01732263|O3|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
154288|NCT01732263|O2|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
154289|NCT01732263|O1|Outcome|SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
154290|NCT01732263|O6|Outcome|SSP-004184 (Matched Healthy Subjects) 50 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
154291|NCT01732263|O5|Outcome|SSP-004184 (Matched Healthy Subjects) 45 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
154292|NCT01732263|O4|Outcome|SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
154293|NCT01732263|O3|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
154294|NCT01732263|O2|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
154295|NCT01732263|O1|Outcome|SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
154296|NCT01732263|O6|Outcome|SSP-004184 (Matched Healthy Subjects) 50 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
154297|NCT01732263|O5|Outcome|SSP-004184 (Matched Healthy Subjects) 45 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
154383|NCT01731002|O2|Outcome|AR-13324 Ophthalmic Solution 0.02%|1 drop to study eye once daily (QD) in the evening (PM)
162017|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
154298|NCT01732263|O4|Outcome|SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
154299|NCT01732263|O3|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
154300|NCT01732263|O2|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
154301|NCT01732263|O1|Outcome|SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
154302|NCT01732263|O6|Outcome|SSP-004184 (Matched Healthy Subjects) 50 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
154303|NCT01732263|O5|Outcome|SSP-004184 (Matched Healthy Subjects) 45 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
154304|NCT01732263|O4|Outcome|SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
154305|NCT01732263|O3|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
154306|NCT01732263|O2|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
154307|NCT01732263|O1|Outcome|SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
154308|NCT01732263|O6|Outcome|SSP-004184 (Matched Healthy Subjects) 50 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
154309|NCT01732263|O5|Outcome|SSP-004184 (Matched Healthy Subjects) 45 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
154310|NCT01732263|O4|Outcome|SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
154311|NCT01732263|O3|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
154312|NCT01732263|O2|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
154313|NCT01732263|O1|Outcome|SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
154314|NCT01732263|E2|Reported Event|Matched Healthy Subjects|
154315|NCT01732263|E1|Reported Event|Hepatic Impairment|
154316|NCT01731990|B3|Baseline|Total|Total of all reporting groups
154317|NCT01731990|B2|Baseline|Placebo|Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months
154318|NCT01731990|B1|Baseline|Canakinumab (ACZ885)|Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months
154319|NCT01731990|P2|Participant Flow|Placebo|Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months
154320|NCT01731990|P1|Participant Flow|Canakinumab (ACZ885)|Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months
154321|NCT01731990|O2|Outcome|Placebo|Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months
154322|NCT01731990|O1|Outcome|Canakinumab (ACZ885)|Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months
154323|NCT01731990|O2|Outcome|Placebo|Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months
154324|NCT01731990|O1|Outcome|Canakinumab (ACZ885)|Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months
154325|NCT01731990|O2|Outcome|Placebo|Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months
154326|NCT01731990|O1|Outcome|Canakinumab (ACZ885)|Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months
154327|NCT01731990|O2|Outcome|Placebo|Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months
154328|NCT01731990|O1|Outcome|Canakinumab (ACZ885)|Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months
154329|NCT01731990|E2|Reported Event|Placebo|Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months
154330|NCT01731990|E1|Reported Event|Canakinumab (ACZ885)|Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months
154331|NCT01731938|B5|Baseline|Total|Total of all reporting groups
154332|NCT01731938|B4|Baseline|Surgicel® Part II|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.~Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
154333|NCT01731938|B3|Baseline|Fibrin Sealant (FS) Grifols Part II|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).~Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
154334|NCT01731938|B2|Baseline|Surgicel® Part I|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.~Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
154335|NCT01731938|B1|Baseline|Fibrin Sealant (FS) Grifols Part I|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).~Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
154336|NCT01731938|P2|Participant Flow|Surgicel®|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.~Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
154337|NCT01731938|P1|Participant Flow|Fibrin Sealant (FS) Grifols|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).~Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
154338|NCT01731938|O2|Outcome|Surgicel®|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.~Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
154339|NCT01731938|O1|Outcome|Fibrin Sealant (FS) Grifols|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).~Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
154340|NCT01731938|O2|Outcome|Surgicel®|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.~Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
154341|NCT01731938|O1|Outcome|Fibrin Sealant (FS) Grifols|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).~Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
154384|NCT01731002|O1|Outcome|AR-13324 Ophthalmic Solution 0.01%|1 drop to study eye once daily (QD) in the evening (PM)
154343|NCT01731938|O1|Outcome|Fibrin Sealant (FS) Grifols|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).~Fibrin Sealant (FS) Grifols: Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
154344|NCT01731938|O2|Outcome|Surgicel®|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.~Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
154345|NCT01731938|O1|Outcome|Fibrin Sealant (FS) Grifols|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).~Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
154346|NCT01731938|E2|Reported Event|Surgicel®|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.~Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
154347|NCT01731938|E1|Reported Event|Fibrin Sealant (FS) Grifols|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).~Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
154348|NCT01731470|B1|Baseline|Liposomes|"Liposomes~Liposomes: Intravesical instillation of liposomes."
154349|NCT01731470|P1|Participant Flow|Liposomes|"Liposomes~Liposomes: Intravesical instillation of liposomes."
154350|NCT01731470|O1|Outcome|Liposomes|"Liposomes~Liposomes: Intravesical instillation of liposomes."
154351|NCT01731470|O1|Outcome|Liposomes|"Liposomes~Liposomes: Intravesical instillation of liposomes."
154352|NCT01731470|E1|Reported Event|Liposomes|"Liposomes~Liposomes: Intravesical instillation of liposomes."
154353|NCT01731119|B1|Baseline|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.~Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
154354|NCT01731119|P1|Participant Flow|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.~Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
154355|NCT01731119|O1|Outcome|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.~Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
154356|NCT01731119|O1|Outcome|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.~Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
154357|NCT01731119|O1|Outcome|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.~Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
154358|NCT01731119|O1|Outcome|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.~Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
154359|NCT01731119|O1|Outcome|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.~Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
154385|NCT01731002|E3|Reported Event|Latanoprost Ophthalmic Solution 0.005%|1 drop to study eye once daily (QD) in the evening (PM)
154386|NCT01731002|E2|Reported Event|AR-13324 Ophthalmic Solution 0.02%|1 drop to study eye once daily (QD) in the evening (PM)
154387|NCT01731002|E1|Reported Event|AR-13324 Ophthalmic Solution 0.01%|1 drop to study eye once daily (QD) in the evening (PM)
154388|NCT01730846|B4|Baseline|Total|Total of all reporting groups
154360|NCT01731119|E1|Reported Event|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.~Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
154361|NCT01731041|B3|Baseline|Total|Total of all reporting groups
154362|NCT01731041|B2|Baseline|Ticagrelor 90mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
154363|NCT01731041|B1|Baseline|Ticagrelor 180mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
154364|NCT01731041|P2|Participant Flow|Ticagrelor 90mg|A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).
154365|NCT01731041|P1|Participant Flow|Ticagrelor 180mg|A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).
154366|NCT01731041|O2|Outcome|Ticagrelor 90mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
154367|NCT01731041|O1|Outcome|Ticagrelor 180mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
154368|NCT01731041|O2|Outcome|Ticagrelor 90mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
154369|NCT01731041|O1|Outcome|Ticagrelor 180mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
154370|NCT01731041|E2|Reported Event|Ticagrelor 90mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
154371|NCT01731041|E1|Reported Event|Ticagrelor 180mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
154372|NCT01731002|B4|Baseline|Total|Total of all reporting groups
154373|NCT01731002|B3|Baseline|Latanoprost Ophthalmic Solution 0.005%|1 drop to study eye once daily (QD) in the evening (PM)
154374|NCT01731002|B2|Baseline|AR-13324 Ophthalmic Solution 0.02%|1 drop to study eye once daily (QD) in the evening (PM)
154375|NCT01731002|B1|Baseline|AR-13324 Ophthalmic Solution 0.01%|1 drop to study eye once daily (QD) in the evening (PM)
154376|NCT01731002|P3|Participant Flow|Latanoprost Ophthalmic Solution 0.005%|1 drop to study eye once daily (QD) in the evening (PM)
154377|NCT01731002|P2|Participant Flow|AR-13324 Ophthalmic Solution 0.02%|1 drop to study eye once daily (QD) in the evening (PM)
154378|NCT01731002|P1|Participant Flow|AR-13324 Ophthalmic Solution 0.01%|1 drop to study eye once daily (QD) in the evening (PM)
154379|NCT01731002|O3|Outcome|Latanoprost Ophthalmic Solution 0.005%|1 drop to study eye once daily (QD) in the evening (PM)
154380|NCT01731002|O2|Outcome|AR-13324 Ophthalmic Solution 0.02%|1 drop to study eye once daily (QD) in the evening (PM)
154381|NCT01731002|O1|Outcome|AR-13324 Ophthalmic Solution 0.01%|1 drop to study eye once daily (QD) in the evening (PM)
154382|NCT01731002|O3|Outcome|Latanoprost Ophthalmic Solution 0.005%|1 drop to study eye once daily (QD) in the evening (PM)
154390|NCT01730846|B2|Baseline|4mg/Day|"doxazosin 4mg/day~Doxazosin: 4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study."
154391|NCT01730846|B1|Baseline|Placebo|"Placebo~Placebo controlled"
154392|NCT01730846|P3|Participant Flow|8mg/Day|"doxazosin 8mg/day~Doxazosin: 8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study."
154393|NCT01730846|P2|Participant Flow|4mg/Day|"doxazosin 4mg/day~Doxazosin: 4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study."
154394|NCT01730846|P1|Participant Flow|Placebo|"Placebo~Placebo controlled"
154395|NCT01730846|O3|Outcome|8mg/Day|"doxazosin 8mg/day~Doxazosin: 8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study."
154396|NCT01730846|O2|Outcome|4mg/Day|"doxazosin 4mg/day~Doxazosin: 4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study."
154397|NCT01730846|O1|Outcome|Placebo|"Placebo~Placebo controlled"
154398|NCT01730846|O3|Outcome|8mg/Day|"doxazosin 8mg/day~Doxazosin: 8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study."
154399|NCT01730846|O2|Outcome|4mg/Day|"doxazosin 4mg/day~Doxazosin: 4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study."
154400|NCT01730846|O1|Outcome|Placebo|"Placebo~Placebo controlled"
154401|NCT01730846|E3|Reported Event|8mg/Day|"doxazosin 8mg/day~Doxazosin: 8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study."
154402|NCT01730846|E2|Reported Event|4mg/Day|"doxazosin 4mg/day~Doxazosin: 4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study."
154403|NCT01730846|E1|Reported Event|Placebo|"Placebo~Placebo controlled"
154404|NCT01730378|B3|Baseline|Total|Total of all reporting groups
154405|NCT01730378|B2|Baseline|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
154406|NCT01730378|B1|Baseline|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
154407|NCT01730378|P2|Participant Flow|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
154408|NCT01730378|P1|Participant Flow|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
154409|NCT01730378|O2|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
154410|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
154411|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
154412|NCT01730378|O2|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
154413|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
154414|NCT01730378|O2|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
154415|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
154416|NCT01730378|O2|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
154417|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
154418|NCT01730378|O2|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
154419|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
154420|NCT01730378|O2|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
154421|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
154422|NCT01730378|O1|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
154423|NCT01730378|O1|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
154424|NCT01730378|O1|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
155098|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
154425|NCT01730378|O1|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
154426|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
154427|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
154428|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
154429|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
154430|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
154431|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
154432|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
154433|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
154434|NCT01730378|E2|Reported Event|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
154435|NCT01730378|E1|Reported Event|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
154436|NCT01730339|B3|Baseline|Total|Total of all reporting groups
154437|NCT01730339|B2|Baseline|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
154438|NCT01730339|B1|Baseline|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
154439|NCT01730339|P2|Participant Flow|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 milligrams per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
154440|NCT01730339|P1|Participant Flow|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
154441|NCT01730339|O2|Outcome|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
154442|NCT01730339|O1|Outcome|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
154443|NCT01730339|O2|Outcome|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
154444|NCT01730339|O1|Outcome|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
154445|NCT01730339|O2|Outcome|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
154446|NCT01730339|O1|Outcome|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
154447|NCT01730339|O2|Outcome|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
154448|NCT01730339|O1|Outcome|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
162018|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
154449|NCT01730339|O2|Outcome|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
154450|NCT01730339|O1|Outcome|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm, (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
154451|NCT01730339|O4|Outcome|Group 2: Placebo 3* 5 mg/cm|Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
154452|NCT01730339|O3|Outcome|Group 2: PF-06473871: (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
154453|NCT01730339|O2|Outcome|Group 1: Placebo 4* 5 mg/cm|Participants who received 4 intradermal injections of PF-06473871 on one breast, and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
154454|NCT01730339|O1|Outcome|Group 1: PF-06473871: (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
154455|NCT01730339|O4|Outcome|Group 2: Placebo 3* 5 mg/cm|Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
154456|NCT01730339|O3|Outcome|Group 2: PF-06473871: (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
154457|NCT01730339|O2|Outcome|Group 1: Placebo 4* 5 mg/cm|Participants who received 4 intradermal injections of PF-06473871 on one breast, and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
154458|NCT01730339|O1|Outcome|Group 1: PF-06473871: (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
154459|NCT01730339|O4|Outcome|Group 2: Placebo 3* 5 mg/cm|Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
154460|NCT01730339|O3|Outcome|Group 2: PF-06473871: (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
154461|NCT01730339|O2|Outcome|Group 1: Placebo 4* 5 mg/cm|Participants who received 4 intradermal injections of PF-06473871 on one breast, and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
154462|NCT01730339|O1|Outcome|Group 1: PF-06473871: (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
154463|NCT01730339|O4|Outcome|Group 2: Placebo 3* 5 mg/cm|Participants who received 3 intradermal injections of PF-06473871 on one breast, also received 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
154464|NCT01730339|O3|Outcome|Group 2: PF-06473871: (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
154465|NCT01730339|O2|Outcome|Group 1: Placebo 4* 5 mg/cm|Participants who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast
154466|NCT01730339|O1|Outcome|Group 1: PF-06473871: (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
154467|NCT01730339|O4|Outcome|Group 2: Placebo 3* 5 mg/cm|Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
154468|NCT01730339|O3|Outcome|Group 2: PF¬06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
154469|NCT01730339|O2|Outcome|Group 1: Placebo 4* 5 mg/cm|Participants who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
154470|NCT01730339|O1|Outcome|Group 1: PF-06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
154471|NCT01730339|E2|Reported Event|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
154472|NCT01730339|E1|Reported Event|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
154473|NCT01730053|B7|Baseline|Total|Total of all reporting groups
154474|NCT01730053|B6|Baseline|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
155559|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
154475|NCT01730053|B5|Baseline|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
154476|NCT01730053|B4|Baseline|Rosuvastatin 40 mg|.Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
154477|NCT01730053|B3|Baseline|Alirocumab 75/up to 150 + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154478|NCT01730053|B2|Baseline|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154479|NCT01730053|B1|Baseline|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablet orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154480|NCT01730053|P6|Participant Flow|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154481|NCT01730053|P5|Participant Flow|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
154482|NCT01730053|P4|Participant Flow|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
154483|NCT01730053|P3|Participant Flow|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154484|NCT01730053|P2|Participant Flow|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154485|NCT01730053|P1|Participant Flow|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablet orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154486|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154487|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
154488|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
154489|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154490|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154491|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
154841|NCT01729871|O2|Outcome|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
155560|NCT01727141|O4|Outcome|Placebo|b.i.d
154492|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154493|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
154494|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
154495|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154496|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154497|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
154498|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154499|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
154500|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
154501|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154502|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154503|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
154504|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154505|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
154506|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
154507|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154508|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154842|NCT01729871|O1|Outcome|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
155561|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
154509|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
154510|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154511|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
154512|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
154513|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154514|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154515|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
154516|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154517|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
154518|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
154519|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154520|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.
154521|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
154522|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154523|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
154524|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
154525|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154526|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154527|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
154528|NCT01730053|O6|Outcome|Alirocumab 75 mg/ up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154529|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
154530|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
154531|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154532|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154533|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
154534|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154535|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
154536|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
154537|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154538|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154539|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
154540|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154541|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.
154542|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
154543|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154544|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154545|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
154546|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154547|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
154548|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
154549|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154550|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154551|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
154552|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154553|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
154554|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
154555|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154556|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154557|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
154558|NCT01730053|O6|Outcome|Alirocumab 75 mg/ up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154559|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
154560|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
154561|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154843|NCT01729871|O2|Outcome|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
154562|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154563|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
154564|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154565|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
154566|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
154567|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154568|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154569|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
154570|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154571|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154572|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
154573|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154574|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154575|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
154576|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154577|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
154578|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
154596|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
154579|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154580|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154581|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
154582|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154583|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
154584|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
154585|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154586|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154587|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
154588|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154589|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
154590|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
154591|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154592|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154593|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
154594|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154595|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
154632|NCT01730053|E4|Reported Event|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.
154597|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154598|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154599|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
154600|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154601|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
154602|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
154603|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154604|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154605|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
154606|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154607|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
154608|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
154609|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154610|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154611|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
154612|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154613|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
154844|NCT01729871|O1|Outcome|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
155562|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
154614|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
154615|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154616|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154617|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
154618|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154619|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
154620|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
154621|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154622|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154623|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
154624|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154625|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
154626|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
154627|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154628|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154629|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
154630|NCT01730053|E6|Reported Event|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154631|NCT01730053|E5|Reported Event|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.
173025|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
154633|NCT01730053|E3|Reported Event|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154634|NCT01730053|E2|Reported Event|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.
154635|NCT01730053|E1|Reported Event|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.
154636|NCT01730040|B8|Baseline|Total|Total of all reporting groups
154637|NCT01730040|B7|Baseline|Alirocumab 75 mg/ up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154638|NCT01730040|B6|Baseline|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154639|NCT01730040|B5|Baseline|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154640|NCT01730040|B4|Baseline|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154641|NCT01730040|B3|Baseline|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154642|NCT01730040|B2|Baseline|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154643|NCT01730040|B1|Baseline|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154644|NCT01730040|P7|Participant Flow|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154645|NCT01730040|P6|Participant Flow|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154646|NCT01730040|P5|Participant Flow|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154647|NCT01730040|P4|Participant Flow|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154648|NCT01730040|P3|Participant Flow|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154649|NCT01730040|P2|Participant Flow|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154650|NCT01730040|P1|Participant Flow|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154668|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
162019|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
154651|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154652|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154653|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154654|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154655|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154656|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154657|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154658|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154659|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154660|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154661|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154662|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154663|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154664|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154665|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154666|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154667|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154845|NCT01729871|O2|Outcome|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
173026|NCT01665170|O1|Outcome|Placebo|Placebo arm
154669|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154670|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154671|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154672|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154673|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154674|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154675|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154676|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154677|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154678|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154679|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154680|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154681|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154682|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154683|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154684|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154685|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154846|NCT01729871|O1|Outcome|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
154686|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154687|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154688|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154689|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154690|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154691|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154692|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154693|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154694|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154695|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154696|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154697|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154698|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154699|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154700|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154701|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154702|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154847|NCT01729871|O2|Outcome|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
173027|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
154703|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154704|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154705|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154706|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154707|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154708|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154709|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154710|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154711|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154712|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154713|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154714|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154715|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154716|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154717|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154718|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154719|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154848|NCT01729871|O1|Outcome|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
162020|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
154720|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154721|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154722|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154723|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154724|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154725|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154726|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154727|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154728|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154729|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154730|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154731|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154732|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154733|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154734|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154735|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154736|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154849|NCT01729871|O2|Outcome|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
154737|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154738|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154739|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154740|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154741|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154742|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154743|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154744|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154745|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154746|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154747|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154748|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154749|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154750|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154751|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154752|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154753|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154850|NCT01729871|O1|Outcome|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
162021|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
154754|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154755|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154756|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154757|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154758|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154759|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154760|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154761|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154762|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154763|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154764|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154765|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154766|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154767|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154768|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154769|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154770|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154851|NCT01729871|O2|Outcome|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
154771|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154772|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154773|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154774|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154775|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154776|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154777|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154778|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154779|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154780|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154781|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154782|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154783|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154784|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154785|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154786|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154787|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154822|NCT01730040|E4|Reported Event|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
155099|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
154788|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154789|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154790|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154791|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154792|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154793|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154794|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154795|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154796|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154797|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154798|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154799|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154800|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154801|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154802|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154803|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154804|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154839|NCT01729871|P2|Participant Flow|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
154805|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154806|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154807|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154808|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154809|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154810|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154811|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154812|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154813|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154814|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154815|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154816|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154817|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154818|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154819|NCT01730040|E7|Reported Event|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154820|NCT01730040|E6|Reported Event|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection.Q2W added to stable LMT for 24 weeks.
154821|NCT01730040|E5|Reported Event|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
154840|NCT01729871|P1|Participant Flow|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
155256|NCT01728324|B4|Baseline|Total|Total of all reporting groups
154823|NCT01730040|E3|Reported Event|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up¬-titrated to 150 mg Q2W from Week 12 when LDL-¬C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
154824|NCT01730040|E2|Reported Event|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
154825|NCT01730040|E1|Reported Event|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
154826|NCT01729923|B1|Baseline|Treatment (Capecitabine, Celecoxib, Radiation Therapy)|"Patients proceed to surgery, radiation therapy with ADAPT therapy followed by maintenance ADAPT therapy, or ADAPT therapy. Eligible patients undergo surgical resection at baseline or upon achievement of resectable disease after radiation therapy.~RADIATION + ADAPT: Patients undergo radiation therapy 5 days per week and receive capecitabine PO BID and celecoxib PO BID 5 days per week during radiation.~ADAPT: Patients receive capecitabine PO BID on days 1-14 and celecoxib PO BID on days 1-21. Courses repeat every 21 days for up to 3 years in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Celecoxib: Given PO~Intensity-Modulated Radiation Therapy: Undergo IMRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Radiation Therapy: Undergo radiation therapy~Stereotactic Radiosurgery: Undergo stereotactic radiosurgery~Therapeutic Conventional Surgery: Undergo surgical resection"
154827|NCT01729923|P1|Participant Flow|Treatment (Capecitabine, Celecoxib, Radiation Therapy)|"Patients proceed to surgery, radiation therapy with ADAPT therapy followed by maintenance ADAPT therapy, or ADAPT therapy. Eligible patients undergo surgical resection at baseline or upon achievement of resectable disease after radiation therapy.~RADIATION + ADAPT: Patients undergo radiation therapy 5 days per week and receive capecitabine PO BID and celecoxib PO BID 5 days per week during radiation.~ADAPT: Patients receive capecitabine PO BID on days 1-14 and celecoxib PO BID on days 1-21. Courses repeat every 21 days for up to 3 years in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Celecoxib: Given PO~Intensity-Modulated Radiation Therapy: Undergo IMRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Radiation Therapy: Undergo radiation therapy~Stereotactic Radiosurgery: Undergo stereotactic radiosurgery~Therapeutic Conventional Surgery: Undergo surgical resection"
154828|NCT01729923|O1|Outcome|Capecitabine and Celecoxib|Patients are treated with oral capecitabine and celecoxib twice daily 7 days per week. Radiation therapy may be used for selected patients. During radiation, treatment with oral capecitabine and celecoxib will be given twice daily 5 days per week. Surgery may also be used for selected patients.
154829|NCT01729923|O1|Outcome|Capecitabine and Celecoxib|Patients are treated with oral capecitabine and celecoxib twice daily 7 days per week. Radiation therapy may be used for selected patients. During radiation, treatment with oral capecitabine and celecoxib will be given twice daily 5 days per week. Surgery may also be used for selected patients.
154830|NCT01729923|O1|Outcome|Capecitabine and Celecoxib|Patients are treated with oral capecitabine and celecoxib twice daily 7 days per week. Radiation therapy may be used for selected patients. During radiation, treatment with oral capecitabine and celecoxib will be given twice daily 5 days per week. Surgery may also be used for selected patients.
154831|NCT01729923|O1|Outcome|Capecitabine and Celecoxib|Patients are treated with oral capecitabine and celecoxib twice daily 7 days per week. Radiation therapy may be used for selected patients. During radiation, treatment with oral capecitabine and celecoxib will be given twice daily 5 days per week. Surgery may also be used for selected patients.
154832|NCT01729923|O1|Outcome|Capecitabine and Celecoxib|Patients are treated with oral capecitabine and celecoxib twice daily 7 days per week. Radiation therapy may be used for selected patients. During radiation, treatment with oral capecitabine and celecoxib will be given twice daily 5 days per week. Surgery may also be used for selected patients.
154833|NCT01729923|O1|Outcome|Capecitabine and Celecoxib|Patients are treated with oral capecitabine and celecoxib twice daily 7 days per week. Radiation therapy may be used for selected patients. During radiation, treatment with oral capecitabine and celecoxib will be given twice daily 5 days per week. Surgery may also be used for selected patients.
154834|NCT01729923|O1|Outcome|Capecitabine and Celecoxib|Patients are treated with oral capecitabine and celecoxib twice daily 7 days per week. Radiation therapy may be used for selected patients. During radiation, treatment with oral capecitabine and celecoxib will be given twice daily 5 days per week. Surgery may also be used for selected patients.
154835|NCT01729923|E1|Reported Event|Treatment (Capecitabine, Celecoxib, Radiation Therapy)|"Patients proceed to surgery, radiation therapy with ADAPT therapy followed by maintenance ADAPT therapy, or ADAPT therapy. Eligible patients undergo surgical resection at baseline or upon achievement of resectable disease after radiation therapy.~RADIATION + ADAPT: Patients undergo radiation therapy 5 days per week and receive capecitabine PO BID and celecoxib PO BID 5 days per week during radiation.~ADAPT: Patients receive capecitabine PO BID on days 1-14 and celecoxib PO BID on days 1-21. Courses repeat every 21 days for up to 3 years in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Celecoxib: Given PO~Intensity-Modulated Radiation Therapy: Undergo IMRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Radiation Therapy: Undergo radiation therapy~Stereotactic Radiosurgery: Undergo stereotactic radiosurgery~Therapeutic Conventional Surgery: Undergo surgical resection"
154836|NCT01729871|B3|Baseline|Total|Total of all reporting groups
154837|NCT01729871|B2|Baseline|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
154838|NCT01729871|B1|Baseline|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
155563|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
154852|NCT01729871|O1|Outcome|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
154853|NCT01729871|E2|Reported Event|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
154854|NCT01729871|E1|Reported Event|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
154855|NCT01729845|B4|Baseline|Total|Total of all reporting groups
154856|NCT01729845|B3|Baseline|Dose Level 3: 10-Days of Decitabine-MEC|"Patients receive decitabine IV days -14 to -5 (dose level 3).~INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV~Decitabine: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
154857|NCT01729845|B2|Baseline|Dose Level 2: 7-Days of Decitabine-MEC|"Patients receive decitabine IV days -11 to -5 (dose level 2).~INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV~Decitabine: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
154858|NCT01729845|B1|Baseline|Dose Level 1: 5-Days of Decitabine-MEC|"Patients receive decitabine IV days -9 to -5 (dose level 1).~INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV~Decitabine: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mitoxantrone Hydrochloride: Given IV"
154859|NCT01729845|P3|Participant Flow|Dose Level 3: 10-days of Decitabine-MEC|"Patients receive decitabine IV days -14 to -5 (dose level 3).~INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Mitoxantrone Hydrochloride: Given IV"
154860|NCT01729845|P2|Participant Flow|Dose Level 2: 7-Days of Decitabine-MEC|"Patients receive decitabine IV days -11 to -5 (dose level 2).~INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV~Decitabine: Given IV~Etoposide: Given IV~Mitoxantrone Hydrochloride: Given IV"
154861|NCT01729845|P1|Participant Flow|Dose Level 1: 5-Days of Decitabine-MEC|"Patients receive decitabine IV days -9 to -5 (dose level 1).~INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV~Decitabine: Given IV~Etoposide: Given IV~Mitoxantrone Hydrochloride: Given IV"
154862|NCT01729845|O1|Outcome|Dose Level 2: 7-Days of Decitabine-MEC|"Patients receive decitabine IV days -11 to -5 (dose level 2). INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies Mitoxantrone Hydrochloride: Given IV"
154863|NCT01729845|O1|Outcome|Dose Level 2: 7-Days of Decitabine-MEC|"Patients receive decitabine IV on days -11 to -5 (dose level 2)~INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV~Decitabine: Given IV~Etoposide: Given IV~Mitoxantrone Hydrochloride: Given IV"
154864|NCT01729845|O1|Outcome|Dose Level 2: 7-Days of Decitabine-MEC|"Patients receive decitabine IV days -11 to -5 (dose level 2). INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies Mitoxantrone Hydrochloride: Given IV"
154865|NCT01729845|O3|Outcome|Dose Level 3: 10-Days of Decitabine-MEC|"Patients receive decitabine IV days -14 to -5 (dose level 1).~INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies Mitoxantrone Hydrochloride: Given IV"
154866|NCT01729845|O2|Outcome|Dose Level 2: 7-Days of Decitabine-MEC|"Patients receive decitabine IV days -11 to -5 (dose level 2). INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies Mitoxantrone Hydrochloride: Given IV"
154867|NCT01729845|O1|Outcome|Dose Level 1: 5-Days of Decitabine-MEC|"Patients receive decitabine IV days -9 to -5 (dose level 1). INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies Mitoxantrone Hydrochloride: Given IV~Decitabine: Given IV~Etoposide: Given IV~Mitoxantrone Hydrochloride: Given IV"
154899|NCT01729728|O3|Outcome|ALT Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154900|NCT01729728|O2|Outcome|ALT Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154868|NCT01729845|E3|Reported Event|Dose Level 3: 10-days of Decitabine-MEC|"Patients receive decitabine IV days -14 to -5 (dose level 3).~INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Mitoxantrone Hydrochloride: Given IV"
154869|NCT01729845|E2|Reported Event|Dose Level 2: 7-Days of Decitabine-MEC|"Patients receive decitabine IV days -11 to -5 (dose level 2).~INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Mitoxantrone Hydrochloride: Given IV"
154870|NCT01729845|E1|Reported Event|Dose Level 1: 5-Days of Decitabine-MEC|"Patients receive decitabine IV days -9 to -5 (dose level 1).~INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.~Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Mitoxantrone Hydrochloride: Given IV"
154871|NCT01729728|B4|Baseline|Total|Total of all reporting groups
154872|NCT01729728|B3|Baseline|Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154873|NCT01729728|B2|Baseline|Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154874|NCT01729728|B1|Baseline|Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154875|NCT01729728|P3|Participant Flow|Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight)
154876|NCT01729728|P2|Participant Flow|Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight)
154877|NCT01729728|P1|Participant Flow|Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight)
154878|NCT01729728|O3|Outcome|TL Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154879|NCT01729728|O2|Outcome|TL Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154880|NCT01729728|O1|Outcome|TL Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154881|NCT01729728|O3|Outcome|ALP Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154882|NCT01729728|O2|Outcome|ALP Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154883|NCT01729728|O1|Outcome|ALP Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154884|NCT01729728|O3|Outcome|CK Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154885|NCT01729728|O2|Outcome|CK Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154886|NCT01729728|O1|Outcome|CK Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154887|NCT01729728|O3|Outcome|Protein Concentration: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154888|NCT01729728|O2|Outcome|Protein Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154889|NCT01729728|O1|Outcome|Protein Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154890|NCT01729728|O3|Outcome|LDH Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154891|NCT01729728|O2|Outcome|LDH Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154892|NCT01729728|O1|Outcome|LDH Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154893|NCT01729728|O3|Outcome|Bilirubin Concentration: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154894|NCT01729728|O2|Outcome|Bilirubin Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154895|NCT01729728|O1|Outcome|Bilirubin Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154896|NCT01729728|O3|Outcome|GGT Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154897|NCT01729728|O2|Outcome|GGT Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154898|NCT01729728|O1|Outcome|GGT Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154901|NCT01729728|O1|Outcome|ALT Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154902|NCT01729728|O3|Outcome|Urine pH: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154903|NCT01729728|O2|Outcome|Urine pH: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154904|NCT01729728|O1|Outcome|Urine pH: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154905|NCT01729728|O3|Outcome|Specific Gravity Urine: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154906|NCT01729728|O2|Outcome|Specific Gravity Urine: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154907|NCT01729728|O1|Outcome|Specific Gravity Urine: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154908|NCT01729728|O3|Outcome|Glomerular Filtration Rate: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154909|NCT01729728|O2|Outcome|Glomerular Filtration Rate: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154910|NCT01729728|O1|Outcome|Glomerular Filtration Rate: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154911|NCT01729728|O3|Outcome|Urate: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154912|NCT01729728|O2|Outcome|Urate: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154913|NCT01729728|O1|Outcome|Urate: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154914|NCT01729728|O3|Outcome|Albumin Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154915|NCT01729728|O2|Outcome|Albumin Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154916|NCT01729728|O1|Outcome|Albumin Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154917|NCT01729728|O3|Outcome|Triglycerides Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154918|NCT01729728|O2|Outcome|Triglycerides Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154919|NCT01729728|O1|Outcome|Triglycerides Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154920|NCT01729728|O3|Outcome|AST Activity: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154921|NCT01729728|O2|Outcome|AST Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154922|NCT01729728|O1|Outcome|AST Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154923|NCT01729728|O3|Outcome|Creatinine Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154924|NCT01729728|O2|Outcome|Creatinine Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154925|NCT01729728|O1|Outcome|Creatinine Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154926|NCT01729728|O3|Outcome|BUN Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154927|NCT01729728|O2|Outcome|BUN Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154928|NCT01729728|O1|Outcome|BUN Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154929|NCT01729728|O3|Outcome|Blood Phosphate Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154930|NCT01729728|O2|Outcome|Blood Phosphate Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154931|NCT01729728|O1|Outcome|Blood Phosphate Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154932|NCT01729728|O3|Outcome|Blood Chloride Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154933|NCT01729728|O2|Outcome|Blood Chloride Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
155564|NCT01727141|O4|Outcome|Placebo|b.i.d
154934|NCT01729728|O1|Outcome|Blood Chloride Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154935|NCT01729728|O3|Outcome|Blood Calcium Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154936|NCT01729728|O2|Outcome|Blood Calcium Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154937|NCT01729728|O1|Outcome|Blood Calcium Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154938|NCT01729728|O3|Outcome|Blood Potassium Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154939|NCT01729728|O2|Outcome|Blood Potassium Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154940|NCT01729728|O1|Outcome|Blood Potassium Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154941|NCT01729728|O3|Outcome|Blood Sodium Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154942|NCT01729728|O2|Outcome|Blood Sodium Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154943|NCT01729728|O1|Outcome|Blood Sodium Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154944|NCT01729728|O3|Outcome|Blood Glucose Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154945|NCT01729728|O2|Outcome|Blood Glucose Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154946|NCT01729728|O1|Outcome|Blood Glucose Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154947|NCT01729728|O3|Outcome|Leukocyte Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154948|NCT01729728|O2|Outcome|Leukocyte Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154949|NCT01729728|O1|Outcome|Leukocyte Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154950|NCT01729728|O3|Outcome|Platelet Count: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154951|NCT01729728|O2|Outcome|Platelet Count: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154952|NCT01729728|O1|Outcome|Platelet Count: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154953|NCT01729728|O3|Outcome|Mean Corpuscular Volume: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154954|NCT01729728|O2|Outcome|Mean Corpuscular Volume: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154955|NCT01729728|O1|Outcome|Mean Corpuscular Volume: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154956|NCT01729728|O3|Outcome|Hematocrit: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154957|NCT01729728|O2|Outcome|Hematocrit: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154958|NCT01729728|O1|Outcome|Hematocrit: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154959|NCT01729728|O3|Outcome|Hemoglobin Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154960|NCT01729728|O2|Outcome|Hemoglobin Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154961|NCT01729728|O1|Outcome|Hemoglobin Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154962|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Non-Compartmental PK Parameter: Tmax|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154963|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Non-Compartmental PK Parameter: Cmax|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154964|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Non-Compartmental PK Parameter: AUC|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154965|NCT01729728|O1|Outcome|Tapentadol Non-Compartmental PK Parameter: Tmax|Tapentadol oral solution single dose (1mg/kg body weight) of participants aged 12 years to less than 18 years old.
155565|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
155566|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
154966|NCT01729728|O3|Outcome|Young and Very Young Children With Supplementary Analgesic|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154967|NCT01729728|O2|Outcome|Older Children With Supplementary Analgesic|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154968|NCT01729728|O1|Outcome|Adolescents With Supplementary Analgesic|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154969|NCT01729728|O3|Outcome|Number of TEAEs: Young and Very Young Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 2 years and less than 6 years of age.
154970|NCT01729728|O2|Outcome|Number of TEAEs: Older Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 6 years and less than 12 years of age.
154971|NCT01729728|O1|Outcome|Number of TEAEs: Adolescents|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 12 years and less than 18 years of age.
154972|NCT01729728|O1|Outcome|Tapentadol Non-Compartmental PK Parameter: Cmax|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154973|NCT01729728|O3|Outcome|ECG Heart Rate Change: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154974|NCT01729728|O2|Outcome|ECG Heart Rate Change: Older Children|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154975|NCT01729728|O1|Outcome|ECG Heart Rate Change: Adolescents|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154976|NCT01729728|O3|Outcome|ECG Changes: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154977|NCT01729728|O2|Outcome|ECG Changes: Older Children|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154978|NCT01729728|O1|Outcome|ECG Changes: Adolescents|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154979|NCT01729728|O3|Outcome|Blood Pressure: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154980|NCT01729728|O2|Outcome|Blood Pressure: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154981|NCT01729728|O1|Outcome|Blood Pressure: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154982|NCT01729728|O3|Outcome|Oxygen Saturation: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154983|NCT01729728|O2|Outcome|Oxygen Saturation: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154984|NCT01729728|O1|Outcome|Oxygen Saturation: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154985|NCT01729728|O3|Outcome|Respiratory Rates: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154986|NCT01729728|O2|Outcome|Respiratory Rates: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154987|NCT01729728|O1|Outcome|Respiratory Rates: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154988|NCT01729728|O1|Outcome|Tapentadol Non-Compartmental PK Parameter: AUC|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
154989|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Concentrations: Very Young Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 2 years and less than 3 years of age.
154990|NCT01729728|O1|Outcome|Tapentadol Serum Concentrations: Very Young Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 2 years and less than 3 years of age.
154991|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Serum Concentrations Younger Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 3 years and less than 6 years of age.
154992|NCT01729728|O1|Outcome|Tapentadol Serum Concentrations: Younger Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 3 years and less than 6 years of age.
154993|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Serum Concentrations: Older Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 6 years and less than 12 years of age.
154994|NCT01729728|O1|Outcome|Tapentadol Serum Concentrations: Older Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 6 years and less than 12 years of age.
154995|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Serum Concentrations: Adolescents|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 12 years and less than 18 years of age.
154996|NCT01729728|O1|Outcome|Sum of Pain Intensity Differences|"The sum of pain intensity difference over 4 hours (SPID4) were calculated as the weighted sum of the scheduled pain intensity difference collected up to 4 hours after tapentadol oral solution administration.~The time elapsed (in hours) since the previous measurement is multiplied with the pain intensity difference (PID) at the respective time, and defines the weight in the calculation of the weighted sum of pain intensity differences."
154997|NCT01729728|O1|Outcome|Face, Legs, Activity, Cry, Consolability Scale|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
155567|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
154998|NCT01729728|O2|Outcome|Faces Pain Scale: Young Children|Single Dose of Tapentadol Oral Solution in Children Age 3 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight). The children aged 2 were assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) Scale and not the 6-point Faces Pain Scale - Revised.
154999|NCT01729728|O1|Outcome|Faces Pain Scale: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight)
155000|NCT01729728|O2|Outcome|McGrath Color Analog Scale: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
155001|NCT01729728|O1|Outcome|McGrath Color Analog Scale: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
155002|NCT01729728|O1|Outcome|Visual Analog Scale: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
155003|NCT01729728|O1|Outcome|Tapentadol Serum Concentrations: Adolescents|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 12 years and less than 18 years of age.
155004|NCT01729728|E3|Reported Event|Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
155005|NCT01729728|E2|Reported Event|Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
155006|NCT01729728|E1|Reported Event|Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
155007|NCT01729559|B3|Baseline|Total|Total of all reporting groups
155008|NCT01729559|B2|Baseline|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
155009|NCT01729559|B1|Baseline|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
155010|NCT01729559|P2|Participant Flow|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
155011|NCT01729559|P1|Participant Flow|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
155012|NCT01729559|O2|Outcome|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
155013|NCT01729559|O1|Outcome|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
155014|NCT01729559|O2|Outcome|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
155015|NCT01729559|O1|Outcome|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
155016|NCT01729559|O2|Outcome|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
155017|NCT01729559|O1|Outcome|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
155018|NCT01729559|O2|Outcome|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
155019|NCT01729559|O1|Outcome|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
155020|NCT01729559|E2|Reported Event|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
155021|NCT01729559|E1|Reported Event|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
155090|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
155568|NCT01727141|E4|Reported Event|Placebo|b.i.d
155022|NCT01729338|B1|Baseline|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
155023|NCT01729338|P1|Participant Flow|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
155024|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
155025|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
155026|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
155027|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
155028|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
155091|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
155092|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
155093|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
155029|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
155030|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
155031|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
155032|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
155033|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
155034|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
155035|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
155094|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
155095|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
155096|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
155036|NCT01729338|E1|Reported Event|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
155037|NCT01729247|B1|Baseline|FeNO|Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
155038|NCT01729247|P1|Participant Flow|FeNO|Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
155039|NCT01729247|O1|Outcome|FeNO|Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
155040|NCT01729247|O3|Outcome|High Airway Inflammation|As categorized by physician assessment
155041|NCT01729247|O2|Outcome|Intermediate Airway Inflammation|As categorized by physician assessment
155042|NCT01729247|O1|Outcome|Low Airway Inflammation|As categorized by physician assessment
155043|NCT01729247|O3|Outcome|High Airway Inflammation|As categorized by physician assessment
155044|NCT01729247|O2|Outcome|Intermediate Airway Inflammation|As categorized by physician assessment
155045|NCT01729247|O1|Outcome|Low Airway Inflammation|As categorized by physician assessment
155046|NCT01729247|O2|Outcome|No ICS Use|Participants that did not use inhaled corticosteroids (ICS) or ICS/long-acting beta-agonist (LABA)
155047|NCT01729247|O1|Outcome|ICS Use|Participants that used inhaled corticosteroids (ICS) or ICS/long-acting beta-agonist (LABA)
155048|NCT01729247|O2|Outcome|High ACT Score|Participants who had an asthma control test (ACT) score of >19, which indicates well-controlled asthma
155049|NCT01729247|O1|Outcome|Low ACT Score|Participants who had an asthma control test (ACT) score of <=19, which indicates less well-controlled asthma
155050|NCT01729247|E1|Reported Event|FeNO|Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
155051|NCT01729026|B3|Baseline|Total|Total of all reporting groups
155052|NCT01729026|B2|Baseline|Wait-list, Then Adoption After 3 Months|"After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
155053|NCT01729026|B1|Baseline|Shelter Dog Adoption|"Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
155054|NCT01729026|P2|Participant Flow|Wait-list, Then Adoption After 3 Months|"After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
155055|NCT01729026|P1|Participant Flow|Shelter Dog Adoption|"Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
155056|NCT01729026|O2|Outcome|Wait-list, Then Adoption After 3 Months|"After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
155569|NCT01727141|E3|Reported Event|NVA237|12.5 ug b.i.d.
155057|NCT01729026|O1|Outcome|Shelter Dog Adoption|"Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
155058|NCT01729026|E2|Reported Event|Wait-list, Then Adoption After 3 Months|"After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
155059|NCT01729026|E1|Reported Event|Shelter Dog Adoption|"Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
155060|NCT01728792|B6|Baseline|Total|Total of all reporting groups
155061|NCT01728792|B5|Baseline|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
155062|NCT01728792|B4|Baseline|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
155063|NCT01728792|B3|Baseline|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
155064|NCT01728792|B2|Baseline|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
155065|NCT01728792|B1|Baseline|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
155066|NCT01728792|P5|Participant Flow|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
155067|NCT01728792|P4|Participant Flow|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
155068|NCT01728792|P3|Participant Flow|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
155069|NCT01728792|P2|Participant Flow|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
155070|NCT01728792|P1|Participant Flow|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
155071|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
155072|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
155073|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
155074|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
155075|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
155076|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
155077|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
155078|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
155079|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
155080|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
155081|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
155082|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
155083|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
155084|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
155085|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
155086|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
155087|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
155088|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
155089|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
155570|NCT01727141|E2|Reported Event|QAB149|27.5 ug b.i.d.
155100|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
155101|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
155102|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
155103|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
155104|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
155105|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
155106|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
155107|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
155108|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
155109|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
155110|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
155111|NCT01728792|E5|Reported Event|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
155112|NCT01728792|E4|Reported Event|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
155113|NCT01728792|E3|Reported Event|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
155114|NCT01728792|E2|Reported Event|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
155115|NCT01728792|E1|Reported Event|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
155116|NCT01728584|B5|Baseline|Total|Total of all reporting groups
155117|NCT01728584|B4|Baseline|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
155118|NCT01728584|B3|Baseline|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
155119|NCT01728584|B2|Baseline|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
155120|NCT01728584|B1|Baseline|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
155121|NCT01728584|P4|Participant Flow|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
155122|NCT01728584|P3|Participant Flow|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 Post Tetanic Counts [PTCs])/Standard insufflation pressure (starting pressure of 12 mmHg).
155123|NCT01728584|P2|Participant Flow|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
155124|NCT01728584|P1|Participant Flow|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard (Std) NMB (depth of blockade at a targeted Train of Four [TOF] ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
155125|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
155126|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
155127|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
155128|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
155129|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
155130|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
155131|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
155132|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
155133|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
155134|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
155135|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
155136|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
155137|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
155138|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
155139|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
155140|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
155141|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
155142|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
155143|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
155144|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
155145|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
155146|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
155147|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
155148|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
155149|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
155150|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
155151|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
155152|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
155153|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
155154|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
155155|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
155156|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
155157|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
155158|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
155159|NCT01728584|O4|Outcome|Low Insufflation Pressure|Treatment condition for this reporting group is Low insufflation pressure (starting pressure of 8 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Low insufflation pressure and Deep NMB/Low insufflation pressure.
155160|NCT01728584|O3|Outcome|Standard Insufflation Pressure|Treatment condition for this reporting group is Standard insufflation pressure (starting pressure of 12 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Deep NMB/Standard insufflation pressure.
155161|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
155162|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
155163|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
155164|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
155165|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
155166|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
155167|NCT01728584|O4|Outcome|Low Insufflation Pressure|Treatment condition for this reporting group is Low insufflation pressure (starting pressure of 8 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Low insufflation pressure and Deep NMB/Low insufflation pressure.
155168|NCT01728584|O3|Outcome|Standard Insufflation Pressure|Treatment condition for this reporting group is Standard insufflation pressure (starting pressure of 12 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Deep NMB/Standard insufflation pressure.
155169|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
155170|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
155171|NCT01728584|E4|Reported Event|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
155172|NCT01728584|E3|Reported Event|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
155173|NCT01728584|E2|Reported Event|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
155174|NCT01728584|E1|Reported Event|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
155175|NCT01728376|B7|Baseline|Total|Total of all reporting groups
155176|NCT01728376|B6|Baseline|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155177|NCT01728376|B5|Baseline|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155178|NCT01728376|B4|Baseline|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155179|NCT01728376|B3|Baseline|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155180|NCT01728376|B2|Baseline|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155181|NCT01728376|B1|Baseline|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155182|NCT01728376|P6|Participant Flow|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155257|NCT01728324|B3|Baseline|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
162022|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
155183|NCT01728376|P5|Participant Flow|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155184|NCT01728376|P4|Participant Flow|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155185|NCT01728376|P3|Participant Flow|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155186|NCT01728376|P2|Participant Flow|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155187|NCT01728376|P1|Participant Flow|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155188|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155189|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155190|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155191|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155192|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155193|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155194|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155195|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155196|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155197|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155198|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155199|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
173028|NCT01665170|O1|Outcome|Placebo|Placebo arm
155200|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155201|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155202|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155203|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155204|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155205|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155206|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155207|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155208|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155209|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155210|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155211|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155212|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155213|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155214|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155215|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155216|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
173029|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
155217|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155218|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155219|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155220|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155221|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155222|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155223|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155224|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155225|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155226|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155227|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155228|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155229|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155230|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155231|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155232|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155233|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155571|NCT01727141|E1|Reported Event|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
155234|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155235|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155236|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155237|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155238|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155239|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155240|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155241|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155242|NCT01728376|E6|Reported Event|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155243|NCT01728376|E5|Reported Event|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155244|NCT01728376|E4|Reported Event|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155245|NCT01728376|E3|Reported Event|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155246|NCT01728376|E2|Reported Event|Comparator - 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
155247|NCT01728376|E1|Reported Event|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
155248|NCT01728337|B1|Baseline|Xeomin and Dysport|Xeomin® was injected on the one side of the forehead and Dysport® was injected on the other side of the forehead.
155249|NCT01728337|P1|Participant Flow|Dysport and Xeomin|Dysport® was injected on the one side of the forehead and Xeomin® was injected on the other side of the forehead.
155250|NCT01728337|O2|Outcome|Xeomin|Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead.
155251|NCT01728337|O1|Outcome|Dysport|Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.
155252|NCT01728337|O2|Outcome|Xeomin|Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead.
155253|NCT01728337|O1|Outcome|Dysport|Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.
155254|NCT01728337|E2|Reported Event|Xeomin|Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead.
155255|NCT01728337|E1|Reported Event|Dysport|Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.
155258|NCT01728324|B2|Baseline|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
155259|NCT01728324|B1|Baseline|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
155260|NCT01728324|P3|Participant Flow|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
155261|NCT01728324|P2|Participant Flow|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
155262|NCT01728324|P1|Participant Flow|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
155263|NCT01728324|O3|Outcome|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
155264|NCT01728324|O2|Outcome|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
155265|NCT01728324|O1|Outcome|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
155266|NCT01728324|O3|Outcome|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
155267|NCT01728324|O2|Outcome|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
155268|NCT01728324|O1|Outcome|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
155269|NCT01728324|O3|Outcome|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
155270|NCT01728324|O2|Outcome|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
155271|NCT01728324|O1|Outcome|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
155272|NCT01728324|O3|Outcome|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
155273|NCT01728324|O2|Outcome|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
155274|NCT01728324|O1|Outcome|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
155275|NCT01728324|O2|Outcome|16-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group|This is the combination of 16 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients and for 24 weeks in cirrhotic patients
155276|NCT01728324|O1|Outcome|24-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic and cirrhotic patients.
155277|NCT01728324|E3|Reported Event|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
155278|NCT01728324|E2|Reported Event|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
155279|NCT01728324|E1|Reported Event|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
155280|NCT01728246|B3|Baseline|Total|Total of all reporting groups
155281|NCT01728246|B2|Baseline|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
155282|NCT01728246|B1|Baseline|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
155283|NCT01728246|P2|Participant Flow|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
155284|NCT01728246|P1|Participant Flow|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
155285|NCT01728246|O2|Outcome|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
155286|NCT01728246|O1|Outcome|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
155287|NCT01728246|O2|Outcome|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
155288|NCT01728246|O1|Outcome|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
155289|NCT01728246|O2|Outcome|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
155290|NCT01728246|O1|Outcome|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
155291|NCT01728246|O2|Outcome|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
155292|NCT01728246|O1|Outcome|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
155293|NCT01728246|O2|Outcome|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
155294|NCT01728246|O1|Outcome|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
155295|NCT01728246|O2|Outcome|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
155296|NCT01728246|O1|Outcome|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
155297|NCT01728246|E2|Reported Event|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
155298|NCT01728246|E1|Reported Event|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
155299|NCT01728116|B3|Baseline|Total|Total of all reporting groups
155300|NCT01728116|B2|Baseline|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
155301|NCT01728116|B1|Baseline|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
155302|NCT01728116|P2|Participant Flow|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.Medical Nutritional Therapy (MNT) counseling (as defined by the 2012 American Diabetes Association guidelines) was to be conducted at Baseline then Weeks 13, 26, 39, and 52.
155303|NCT01728116|P1|Participant Flow|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device. Medical Nutritional Therapy (MNT) counseling (as defined by the 2012 American Diabetes Association guidelines) was to be conducted at Baseline then Weeks 13, 26, 39, and 52 for both groups, and additionally at Week 65 for the EndoBarrier group.
155304|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
155305|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
155306|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
155307|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
155308|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
155309|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
155310|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
155311|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
155312|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
155313|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
155314|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
155315|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
155316|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
155317|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
155318|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
155319|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
173030|NCT01665170|O1|Outcome|Placebo|Placebo arm
155320|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
155321|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
155322|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
155323|NCT01728116|E2|Reported Event|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
155324|NCT01728116|E1|Reported Event|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
155325|NCT01728077|B3|Baseline|Total Title|
155326|NCT01728077|B2|Baseline|Brivaracetam Generalized Epilepsy|This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day.
155327|NCT01728077|B1|Baseline|Brivaracetam Focal Epilepsy|This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day.
155328|NCT01728077|P2|Participant Flow|Brivaracetam Generalized Epilepsy|This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day.
155329|NCT01728077|P1|Participant Flow|Brivaracetam Focal Epilepsy|This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day.
155330|NCT01728077|O1|Outcome|Brivaracetam Focal Epilepsy (EAS)|This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Efficacy Analysis Set (EAS).
155331|NCT01728077|O1|Outcome|Brivaracetam Focal Epilepsy (EAS)|This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Efficacy Analysis Set (EAS).
155332|NCT01728077|O1|Outcome|Brivaracetam Focal Epilepsy (EAS)|This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Efficacy Analysis Set (EAS).
155333|NCT01728077|O2|Outcome|Brivaracetam Generalized Epilepsy (SS)|This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
155334|NCT01728077|O1|Outcome|Brivaracetam Focal Epilepsy (SS)|This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
155335|NCT01728077|O2|Outcome|Brivaracetam Generalized Epilepsy (SS)|This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
155336|NCT01728077|O1|Outcome|Brivaracetam Focal Epilepsy (SS)|This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
155369|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
173031|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
155337|NCT01728077|O2|Outcome|Brivaracetam Generalized Epilepsy (SS)|This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
155338|NCT01728077|O1|Outcome|Brivaracetam Focal Epilepsy (SS)|This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
155339|NCT01728077|E2|Reported Event|Brivaracetam Generalized Epilepsy (SS)|This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
155340|NCT01728077|E1|Reported Event|Brivaracetam Focal Epilepsy (SS)|This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
155341|NCT01727895|B3|Baseline|Total|Total of all reporting groups
155342|NCT01727895|B2|Baseline|Control Group|No intervention
155343|NCT01727895|B1|Baseline|Beta-glucan|"Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days.~Beta-glucan (Glucan #300®)"
155344|NCT01727895|P2|Participant Flow|Control Group|No intervention
155345|NCT01727895|P1|Participant Flow|Beta-glucan|"Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days.~Beta-glucan (Glucan #300®)"
155346|NCT01727895|O2|Outcome|Control Group|No intervention
155347|NCT01727895|O1|Outcome|Beta-glucan|"Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days.~Beta-glucan (Glucan #300®)"
155348|NCT01727895|E2|Reported Event|Control Group|No intervention
155349|NCT01727895|E1|Reported Event|Beta-glucan|"Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days.~Beta-glucan (Glucan #300®)"
155350|NCT01727791|B1|Baseline|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155351|NCT01727791|P1|Participant Flow|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155352|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155353|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155354|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155355|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155356|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155357|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155358|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155359|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155360|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155361|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155362|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155363|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155364|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155365|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155366|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155367|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155368|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155497|NCT01727258|E3|Reported Event|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033).
155370|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155371|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155372|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155373|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155374|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155375|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155376|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155377|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155378|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155379|NCT01727791|E1|Reported Event|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
155380|NCT01727713|B1|Baseline|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
155381|NCT01727713|P1|Participant Flow|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
155382|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
155383|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
155384|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
155385|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
155386|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
155387|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
155388|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
155389|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
155390|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
155391|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
155392|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
155393|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
155394|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
155395|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
155396|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
155397|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
155398|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
155498|NCT01727258|E2|Reported Event|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046).
155399|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
155400|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
155401|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
155402|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
155403|NCT01727713|E1|Reported Event|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
155404|NCT01727700|B4|Baseline|Total|Total of all reporting groups
155405|NCT01727700|B3|Baseline|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
155406|NCT01727700|B2|Baseline|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
155407|NCT01727700|B1|Baseline|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
155408|NCT01727700|P3|Participant Flow|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
155409|NCT01727700|P2|Participant Flow|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
155410|NCT01727700|P1|Participant Flow|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
155411|NCT01727700|O3|Outcome|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
155412|NCT01727700|O2|Outcome|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
155413|NCT01727700|O1|Outcome|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
155414|NCT01727700|O3|Outcome|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
155415|NCT01727700|O2|Outcome|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
155416|NCT01727700|O1|Outcome|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
155417|NCT01727700|O3|Outcome|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
155418|NCT01727700|O2|Outcome|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
155419|NCT01727700|O1|Outcome|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
155420|NCT01727700|O3|Outcome|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
155499|NCT01727258|E1|Reported Event|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007).
173032|NCT01665170|O1|Outcome|Placebo|Placebo arm
155421|NCT01727700|O2|Outcome|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
155422|NCT01727700|O1|Outcome|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
155423|NCT01727700|O3|Outcome|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
155424|NCT01727700|O2|Outcome|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
155425|NCT01727700|O1|Outcome|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
155426|NCT01727700|O3|Outcome|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
155427|NCT01727700|O2|Outcome|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
155428|NCT01727700|O1|Outcome|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
155429|NCT01727700|E3|Reported Event|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
155430|NCT01727700|E2|Reported Event|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
155431|NCT01727700|E1|Reported Event|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
155432|NCT01727505|B1|Baseline|Study Population|"This is a crossover study. Infants were randomly assigned to one of two sequences.~Sequence A consisted of 24 hours of Conventional Mechanical Ventilation followed by 24 hours of Volume Guarantee Ventilation.~Sequence B consisted of 24 hours of Volume Guarantee Ventilation followed by 24 hours of Conventional Mechanical Ventilation."
155433|NCT01727505|P2|Participant Flow|Sequence B: Volume Guarantee-Conventional|"This is a crossover study. Each patient is randomly assigned to one of two sequences.~Sequence B consisted of a 24-hour period during which the infant received volume guarantee ventilation followed by a 24 hour period during which the infant received conventional mechanical ventilation."
155434|NCT01727505|P1|Participant Flow|Sequence A: Conventional-Volume Guarantee|"This is a crossover study. Each patient is randomly assigned to one of two sequences.~Sequence A consisted of a 24-hour period during which the infant received conventional mechanical ventilation followed by a 24 hour period during which the infant received volume guarantee ventilation."
155435|NCT01727505|O2|Outcome|Volume Guarantee Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~The sequence of conventional and volume guarantee ventilation were assigned at random."
155436|NCT01727505|O1|Outcome|Conventional Mechanical Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~The sequence of conventional and volume guarantee ventilation were assigned at random."
155437|NCT01727505|O2|Outcome|Volume Guarantee Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~The sequence of conventional and volume guarantee ventilation were assigned at random."
155438|NCT01727505|O1|Outcome|Conventional Mechanical Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~The sequence of conventional and volume guarantee ventilation were assigned at random."
155439|NCT01727505|O2|Outcome|Volume Guarantee Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~The sequence of conventional and volume guarantee ventilation were assigned at random."
162023|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
155440|NCT01727505|O1|Outcome|Conventional Mechanical Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~The sequence of conventional and volume guarantee ventilation were assigned at random."
155441|NCT01727505|O2|Outcome|Volume Guarantee Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~The sequence of conventional and volume guarantee ventilation were assigned at random."
155442|NCT01727505|O1|Outcome|Conventional Mechanical Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~The sequence of conventional and volume guarantee ventilation were assigned at random."
155443|NCT01727505|O2|Outcome|Volume Guarantee Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~The sequence of conventional and volume guarantee ventilation were assigned at random."
155444|NCT01727505|O1|Outcome|Conventional Mechanical Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~The sequence of conventional and volume guarantee ventilation were assigned at random."
155445|NCT01727505|O2|Outcome|Volume Guarantee Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~The sequence of conventional and volume guarantee ventilation were assigned at random."
155446|NCT01727505|O1|Outcome|Conventional Mechanical Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~The sequence of conventional and volume guarantee ventilation were assigned at random."
155447|NCT01727505|E2|Reported Event|Volume Guarantee Ventilation Period|"This is a crossover study. Infants were randomly assigned to one of two sequences that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~These data represent the 24 hours of Volume Guarantee Ventilation."
155448|NCT01727505|E1|Reported Event|Conventional Mechanical Ventilation Period|"This is a crossover study. Infants were randomly assigned to one of two sequences that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~These data represent the 24 hours of Conventional Mechanical Ventilation."
155449|NCT01727414|B3|Baseline|Total|Total of all reporting groups
155450|NCT01727414|B2|Baseline|Combined Type|
155451|NCT01727414|B1|Baseline|Inattentive Type|
155452|NCT01727414|P2|Participant Flow|Combined Type|"Every participant receives low dose MPH, medium dose MPH, high dose MPH, and placebo for one week each in a triple-blinded fashion.~OROS-Methylphenidate: capsule; dosages - 18mg, 27mg, 36mg, 54 mg; frequency - each AM; duration - one week for each dose, with each child receiving 3 doses [children < 25 kg receive 18mg, 27mg, 36mg; children > or = to 25kg get 18mg, 36mg, 54mg]"
155453|NCT01727414|P1|Participant Flow|Inattentive Type|"Every participant receives low dose MPH, medium dose MPH, high dose MPH, and placebo for one week each in a triple-blinded fashion.~Placebo: capsule, frequency - each AM, duration - 1 week"
155454|NCT01727414|O2|Outcome|Combined Type|"Every participant receives low dose MPH, medium dose MPH, high dose MPH, and placebo for one week each in a triple-blinded fashion.~OROS-Methylphenidate: capsule; dosages - 18mg, 27mg, 36mg, 54 mg; frequency - each AM; duration - one week for each dose, with each child receiving 3 doses [children < 25 kg receive 18mg, 27mg, 36mg; children > or = to 25kg get 18mg, 36mg, 54mg]"
155455|NCT01727414|O1|Outcome|Inattentive Type|"Every participant receives low dose MPH, medium dose MPH, high dose MPH, and placebo for one week each in a triple-blinded fashion.~OROS-Methylphenidate: capsule; dosages - 18mg, 27mg, 36mg, 54 mg; frequency - each AM; duration - one week for each dose, with each child receiving 3 doses [children < 25 kg receive 18mg, 27mg, 36mg; children > or = to 25kg get 18mg, 36mg, 54mg]"
155456|NCT01727414|E2|Reported Event|Combined Type|Children meeting DSM-IV criteria for ADHD-combined type.
155457|NCT01727414|E1|Reported Event|Inattentive Type|Children meeting DSM-IV criteria for ADHD-inattentive type.
155458|NCT01727297|B1|Baseline|Reveal Implantable Cardiac Monitor Implant Attempted|Enrolled subjects who had a Reveal Implantable Cardiac Monitor implant attempt (i.e. underwent the procedure to have a Reveal device implanted)
155459|NCT01727297|P2|Participant Flow|No Reveal Implantable Cardiac Monitor Implant Attempt|Enrolled subjects who exited the study prior to undergoing a procedure to implant a Reveal Implantable Cardiac Monitor
155460|NCT01727297|P1|Participant Flow|Reveal Implantable Cardiac Monitor Implant Attempted|Enrolled subjects who had a Reveal Implantable Cardiac Monitor implant attempt (i.e. underwent the procedure to have a Reveal device implanted)
155461|NCT01727297|O6|Outcome|Sixth Visit With AF Detected|"Enrolled subjects implanted with a Reveal Implantable Cardiac Monitor who:~Did not have diagnosed AF prior to implant,~met the CHADS2 score inclusion criterion (a CHADS2 score of at least 3 or a CHADS2 score of 2 with at least one of the following: coronary artery disease, sleep apnea, renal impairment, or chronic obstructive pulmonary disease),~was not taking an anti-arrhythmic drug at enrollment, and~Had a 6th follow-up visit in which new AF episodes were diagnosed"
155462|NCT01727297|O5|Outcome|Fifth Visit With AF Detected|"Enrolled subjects implanted with a Reveal Implantable Cardiac Monitor who:~Did not have diagnosed AF prior to implant,~met the CHADS2 score inclusion criterion (a CHADS2 score of at least 3 or a CHADS2 score of 2 with at least one of the following: coronary artery disease, sleep apnea, renal impairment, or chronic obstructive pulmonary disease),~was not taking an anti-arrhythmic drug at enrollment, and~Had a 5th follow-up visit in which new AF episodes were diagnosed"
155500|NCT01727180|B1|Baseline|Chronic Kidney Disease|Questionnaire based on the McGill Pain Questionnaire: Interview questionnaire based on the short form of the McGill Pain Questionnaire
155463|NCT01727297|O4|Outcome|Fourth Visit With AF Detected|"Enrolled subjects implanted with a Reveal Implantable Cardiac Monitor who:~Did not have diagnosed AF prior to implant,~met the CHADS2 score inclusion criterion (a CHADS2 score of at least 3 or a CHADS2 score of 2 with at least one of the following: coronary artery disease, sleep apnea, renal impairment, or chronic obstructive pulmonary disease),~was not taking an anti-arrhythmic drug at enrollment, and~Had a 4th follow-up visit in which new AF episodes were diagnosed"
155464|NCT01727297|O3|Outcome|Third Visit With AF Detected|"Enrolled subjects implanted with a Reveal Implantable Cardiac Monitor who:~Did not have diagnosed AF prior to implant,~met the CHADS2 score inclusion criterion (a CHADS2 score of at least 3 or a CHADS2 score of 2 with at least one of the following: coronary artery disease, sleep apnea, renal impairment, or chronic obstructive pulmonary disease),~was not taking an anti-arrhythmic drug at enrollment, and~Had a 3rd follow-up visit in which new AF episodes were diagnosed"
155465|NCT01727297|O2|Outcome|Second Visit With AF Detected|"Enrolled subjects implanted with a Reveal Implantable Cardiac Monitor who:~Did not have diagnosed AF prior to implant,~met the CHADS2 score inclusion criterion (a CHADS2 score of at least 3 or a CHADS2 score of 2 with at least one of the following: coronary artery disease, sleep apnea, renal impairment, or chronic obstructive pulmonary disease),~was not taking an anti-arrhythmic drug at enrollment, and~Had a 2nd follow-up visit in which new AF episodes were diagnosed"
155466|NCT01727297|O1|Outcome|First Visit With AF Detected|"Enrolled subjects implanted with a Reveal Implantable Cardiac Monitor who:~Did not have diagnosed AF prior to implant,~met the CHADS2 score inclusion criterion (a CHADS2 score of at least 3 or a CHADS2 score of 2 with at least one of the following: coronary artery disease, sleep apnea, renal impairment, or chronic obstructive pulmonary disease),~was not taking an anti-arrhythmic drug at enrollment, and~Had a follow-up visit in which new AF episodes were diagnosed"
155467|NCT01727297|O2|Outcome|AF Predictors Analysis Cohort: No AF Episodes|Subjects successfully implanted with a Reveal Implantable Cardiac Monitor (ICM), and who (1) have post-implant ICM device data to evaluate, (2) were not on anti-arrhythmic medication at enrollment, (3) did not have AF prior to Reveal implant, and (4) did not experience an AF episode lasting at least 6 minutes during follow-up.
155468|NCT01727297|O1|Outcome|AF Predictors Analysis Cohort: AF Episodes|Subjects successfully implanted with a Reveal Implantable Cardiac Monitor (ICM), and who (1) have post-implant ICM device data to evaluate, (2) were not on anti-arrhythmic medication at enrollment, (3) did not have AF prior to Reveal implant, and (4) experienced an AF episode lasting at least 6 minutes during follow-up.
155469|NCT01727297|O1|Outcome|Primary Objective Analysis Cohort|Subjects successfully implanted with a Reveal Implantable Cardiac Monitor (ICM), who also (1) have post-implant device data to evaluate, (2) were not on anti-arrhythmic medication at enrollment, (3) did not have AF prior to Reveal ICM implant, and (4) satisfy the Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, prior Stroke or transient ischemic attack (TIA) or thromboembolism (doubled) (CHADS2) inclusion criteria for the study (CHADS2 score of 3 or higher, or a CHADS2 score of 2 along with chronic obstructive pulmonary disease, sleep apnea, renal impairment, or coronary artery disease)
155470|NCT01727297|E2|Reported Event|No Reveal Implantable Cardiac Monitor Implant Attempt|Enrolled subjects who exited the study prior to undergoing a procedure to implant a Reveal Implantable Cardiac Monitor
155471|NCT01727297|E1|Reported Event|Reveal Implantable Cardiac Monitor Implant Attempted|Enrolled subjects who had a Reveal Implantable Cardiac Monitor implant attempt (i.e. underwent the procedure to have a Reveal device implanted)
155472|NCT01727258|B4|Baseline|Total|Total of all reporting groups
155473|NCT01727258|B3|Baseline|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033).
155474|NCT01727258|B2|Baseline|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046).
155475|NCT01727258|B1|Baseline|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007).
155476|NCT01727258|P3|Participant Flow|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033).
155477|NCT01727258|P2|Participant Flow|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046).
155478|NCT01727258|P1|Participant Flow|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007).
155479|NCT01727258|O3|Outcome|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033)
155480|NCT01727258|O2|Outcome|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
155481|NCT01727258|O1|Outcome|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
155482|NCT01727258|O3|Outcome|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033)
155483|NCT01727258|O2|Outcome|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
155484|NCT01727258|O1|Outcome|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
155485|NCT01727258|O3|Outcome|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033)
155486|NCT01727258|O2|Outcome|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
155487|NCT01727258|O1|Outcome|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
155488|NCT01727258|O3|Outcome|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033)
155489|NCT01727258|O2|Outcome|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
155490|NCT01727258|O1|Outcome|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
155491|NCT01727258|O3|Outcome|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033)
155492|NCT01727258|O2|Outcome|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
155493|NCT01727258|O1|Outcome|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
155494|NCT01727258|O3|Outcome|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033)
155495|NCT01727258|O2|Outcome|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
155496|NCT01727258|O1|Outcome|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
162024|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
155501|NCT01727180|P1|Participant Flow|Chronic Kidney Disease|Questionnaire based on the McGill Pain Questionnaire: Interview questionnaire based on the short form of the McGill Pain Questionnaire
155502|NCT01727180|O1|Outcome|Chronic Kidney Disease|Questionnaire based on the McGill Pain Questionnaire: Interview questionnaire based on the short form of the McGill Pain Questionnaire
155503|NCT01727180|E1|Reported Event|Chronic Kidney Disease|Questionnaire based on the McGill Pain Questionnaire: Interview questionnaire based on the short form of the McGill Pain Questionnaire
155504|NCT01727167|B3|Baseline|Total|Total of all reporting groups
155505|NCT01727167|B2|Baseline|CO Group|"This group will breath 200 ppm of CO for one hour per day over the course of the three days immediately prior to surgery.~200ppm CO for one hour: This is the study intervention. The treatment group will breath 200 ppm of CO for one hour over the three days immediately prior to surgery."
155506|NCT01727167|B1|Baseline|Control Group|"This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.~Control: This group will breath room air for one hour per day over the course of the three days immediately prior to surgery."
155507|NCT01727167|P2|Participant Flow|CO Group|"This group will breath 200 ppm of CO for one hour per day over the course of the three days immediately prior to surgery.~200ppm CO for one hour: This is the study intervention. The treatment group will breath 200 ppm of CO for one hour over the three days immediately prior to surgery."
155508|NCT01727167|P1|Participant Flow|Control Group|"This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.~Control: This group will breath room air for one hour per day over the course of the three days immediately prior to surgery."
155509|NCT01727167|O2|Outcome|CO Group|"This group will breath 200 ppm of CO for one hour per day over the course of the three days immediately prior to surgery.~200ppm CO for one hour: This is the study intervention. The treatment group will breath 200 ppm of CO for one hour over the three days immediately prior to surgery."
155510|NCT01727167|O1|Outcome|Control Group|"This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.~Control: This group will breath room air for one hour per day over the course of the three days immediately prior to surgery."
155511|NCT01727167|O2|Outcome|CO Group|"This group will breath 200 ppm of CO for one hour per day over the course of the three days immediately prior to surgery.~200ppm CO for one hour: This is the study intervention. The treatment group will breath 200 ppm of CO for one hour over the three days immediately prior to surgery."
155512|NCT01727167|O1|Outcome|Control Group|"This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.~Control: This group will breath room air for one hour per day over the course of the three days immediately prior to surgery."
155513|NCT01727167|E2|Reported Event|CO Group|"This group will breath 200 ppm of CO for one hour per day over the course of the three days immediately prior to surgery.~200ppm CO for one hour: This is the study intervention. The treatment group will breath 200 ppm of CO for one hour over the three days immediately prior to surgery."
155514|NCT01727167|E1|Reported Event|Control Group|"This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.~Control: This group will breath room air for one hour per day over the course of the three days immediately prior to surgery."
155515|NCT01727141|B5|Baseline|Total|Total of all reporting groups
155516|NCT01727141|B4|Baseline|Placebo|b.i.d
155517|NCT01727141|B3|Baseline|NVA237|12.5 ug b.i.d.
155518|NCT01727141|B2|Baseline|QAB149|27.5 ug b.i.d.
155519|NCT01727141|B1|Baseline|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
155520|NCT01727141|P4|Participant Flow|Placebo|b.i.d
155521|NCT01727141|P3|Participant Flow|NVA237|12.5 ug b.i.d.
155522|NCT01727141|P2|Participant Flow|QAB149|27.5 ug b.i.d.
155523|NCT01727141|P1|Participant Flow|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
155524|NCT01727141|O4|Outcome|Placebo|b.i.d
155525|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
155526|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
155527|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
155528|NCT01727141|O4|Outcome|Placebo|b.i.d
155529|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
155530|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
155531|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
155532|NCT01727141|O4|Outcome|Placebo|b.i.d
155533|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
155534|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
155535|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
155536|NCT01727141|O4|Outcome|Placebo|b.i.d
155537|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
155538|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
155539|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
155540|NCT01727141|O4|Outcome|Placebo|b.i.d
155541|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
155542|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
155543|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
155544|NCT01727141|O4|Outcome|Placebo|b.i.d
155545|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
155546|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
155547|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
155548|NCT01727141|O4|Outcome|Placebo|b.i.d
155549|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
155550|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
155551|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
155552|NCT01727141|O4|Outcome|Placebo|b.i.d
155553|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
155554|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
162025|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
155572|NCT01727024|B1|Baseline|All Randomized Participants|All participants who were randomized either to sequence 1 or sequence 2
155573|NCT01727024|P2|Participant Flow|Tiotropium Respimat® First, Then Indacaterol Breezhaler®|In period 1, participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days, followed by a 7-day washout. In period 2, participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
155574|NCT01727024|P1|Participant Flow|Indacaterol Breezhaler® First, Then Tiotropium Respimat®|In period 1, participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days, followed by a 7-day washout. In period 2, participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
155575|NCT01727024|O2|Outcome|Tiotropium Respimat®|Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
155576|NCT01727024|O1|Outcome|Indacaterol (QAB149) Breezhaler®|Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
155577|NCT01727024|O1|Outcome|Indacaterol (QAB149) Breezhaler®|Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
155578|NCT01727024|O2|Outcome|Tiotropium Respimat®|Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
155579|NCT01727024|O1|Outcome|Indacaterol (QAB149) Breezhaler®|Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
155580|NCT01727024|O2|Outcome|Tiotropium Respimat®|Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
155581|NCT01727024|O1|Outcome|Indacaterol (QAB149) Breezhaler®|Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
155582|NCT01727024|O2|Outcome|Tiotropium Respimat®|Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
155583|NCT01727024|O1|Outcome|Indacaterol (QAB149) Breezhaler®|Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
155584|NCT01727024|E2|Reported Event|Tiotropium Respimat®|Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
155585|NCT01727024|E1|Reported Event|Indacaterol (QAB149) Breezhaler®|Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
155586|NCT01726621|B1|Baseline|Insulin Depedent Diabetics|Subject is current insulin pump user and has CGM experience as determined by the investigator.
155587|NCT01726621|P1|Participant Flow|Insulin Dependent Diabetics|Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 620G and 640G insulin pumps and Guardian Link transmitter
155588|NCT01726621|O1|Outcome|Insulin Depedent Diabetics|Subject is current insulin pump user and has CGM experience as determined by the investigator.
155589|NCT01726621|E1|Reported Event|Insulin Dependent Diabetics|"Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 620G and 640G insulin pumps and Guardian Link transmitter~Medtronic MiniMed 620G or 640G Insulin Pump: Subjects to use the Medtronic MiniMed 620G or 640G Insulin Pump and Guardian Link transmitter to manage their diabetes for 4 - 6 weeks."
155590|NCT01726517|B6|Baseline|Total|Total of all reporting groups
155591|NCT01726517|B5|Baseline|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
155592|NCT01726517|B4|Baseline|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
155593|NCT01726517|B3|Baseline|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
155594|NCT01726517|B2|Baseline|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
155595|NCT01726517|B1|Baseline|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
155596|NCT01726517|P5|Participant Flow|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
155597|NCT01726517|P4|Participant Flow|LDV/SOF 12 Weeks (TE)|Treatment-experienced (TE) participants (had virologic failure following prior therapy with a protease-inhibitor [PI]+pegylated interferon [PEG]+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
155598|NCT01726517|P3|Participant Flow|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
155599|NCT01726517|P2|Participant Flow|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based ribavirin (RBV) (1000-1200 mg) for 8 weeks.
155600|NCT01726517|P1|Participant Flow|LDV/SOF 8 Weeks (TN)|Treatment-naive (TN) participants were randomized to receive ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg for 8 weeks.
155601|NCT01726517|O5|Outcome|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
155602|NCT01726517|O4|Outcome|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
155603|NCT01726517|O3|Outcome|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
155604|NCT01726517|O2|Outcome|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
155605|NCT01726517|O1|Outcome|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
155606|NCT01726517|O5|Outcome|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
155607|NCT01726517|O4|Outcome|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
155608|NCT01726517|O3|Outcome|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
155609|NCT01726517|O2|Outcome|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
155610|NCT01726517|O1|Outcome|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
155611|NCT01726517|O5|Outcome|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
155612|NCT01726517|O4|Outcome|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
155613|NCT01726517|O3|Outcome|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
155614|NCT01726517|O2|Outcome|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
155615|NCT01726517|O1|Outcome|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
155616|NCT01726517|O5|Outcome|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
155617|NCT01726517|O4|Outcome|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
155618|NCT01726517|O3|Outcome|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
155619|NCT01726517|O2|Outcome|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
155620|NCT01726517|O1|Outcome|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
155621|NCT01726517|E5|Reported Event|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
155622|NCT01726517|E4|Reported Event|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
155623|NCT01726517|E3|Reported Event|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
155624|NCT01726517|E2|Reported Event|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
155625|NCT01726517|E1|Reported Event|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
155626|NCT01726504|B3|Baseline|Total|Total of all reporting groups
155627|NCT01726504|B2|Baseline|Sham Electro-acupuncture|The acupuncture points are sham ST25, SP14, ST37. Sham location points are: about 2cm away from ST25,in the middle of the spleen and stomach channel; about 3 cm from SP14, in the middle of the spleen and stomach channel; one point beside ST37, in the middle of the stomach and gallbladder channel. The needle is inserted after sterilizing the skin by 1 to 1.5 cm, until the needle can be vertically fixed on the skin. No twirling lifting and thrusting manipulation is used. The sham electric stimulator (sham SDZ-V EA apparatus; Huatuo) is applied to the bilateral sham ST25 and sham SP14 with a dilatational wave of 10/50 Hz and electric current of 0.5 mA. The metal wire has been cut off inside to give the appearance of the real electric stimulator, with no current output. Length of treatment and the treatment sessions are the same as the treatment group sessions are the same as the treatment group.
155628|NCT01726504|B1|Baseline|Electro-acupuncture|"The acupuncture points are ST25, SP14,ST37. After sterilizing the skin, filiform needles are inserted 3 to 8 cm into bilateral ST25 and SP14 vertically and slowly without any manipulation until arrive the abdominal muscle layer(patients feel painful and acupuncturists feel touching hard). An electric stimulator (SDZ-V EA apparatus; Huatuo, China) is applied to bilateral ST25 and SP14 with a dilatational wave of 10/50 Hz and electric current between 0.1 and 1.0 mA with abdominal muscle twitching mildly indicating the appropriate dose.~The bilateral ST37 is inserted 3cm - twirling, lifting and thrusting three times. A local sour and heavy feeling indicates the appropriate dose.~Every session lasts for 30min/day. The participants are treated continuously for 8 weeks. During 8-week treatment the first 2 weeks,5 sessions per week, and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total."
155629|NCT01726504|P2|Participant Flow|Sham Electro-acupuncture|The acupuncture points are sham ST25, SP14, ST37. Sham location points are: about 2cm away from ST25,in the middle of the spleen and stomach channel; about 3 cm from SP14, in the middle of the spleen and stomach channel; one point beside ST37, in the middle of the stomach and gallbladder channel. The needle is inserted after sterilizing the skin by 1 to 1.5 cm, until the needle can be vertically fixed on the skin. No twirling lifting and thrusting manipulation is used. The sham electric stimulator (sham SDZ-V EA apparatus; Huatuo) is applied to the bilateral sham ST25 and sham SP14 with a dilatational wave of 10/50 Hz and electric current of 0.5 mA. The metal wire has been cut off inside to give the appearance of the real electric stimulator, with no current output. Length of treatment and the treatment sessions are the same as the treatment group sessions are the same as the treatment group.
155630|NCT01726504|P1|Participant Flow|Electro-acupuncture|"The acupuncture points are ST25, SP14,ST37. After sterilizing the skin, filiform needles are inserted 3 to 8 cm into bilateral ST25 and SP14 vertically and slowly without any manipulation until arrive the abdominal muscle layer(patients feel painful and acupuncturists feel touching hard). An electric stimulator (SDZ-V EA apparatus; Huatuo, China) is applied to bilateral ST25 and SP14 with a dilatational wave of 10/50 Hz and electric current between 0.1 and 1.0 mA with abdominal muscle twitching mildly indicating the appropriate dose.~The bilateral ST37 is inserted 3cm - twirling, lifting and thrusting three times. A local sour and heavy feeling indicates the appropriate dose.~Every session lasts for 30min/day. The participants are treated continuously for 8 weeks. During 8-week treatment the first 2 weeks,5 sessions per week, and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total."
162026|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
155631|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
155632|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
155633|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
155634|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
155635|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
155636|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
155637|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
155665|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
155666|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
155638|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
155639|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
155640|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
155641|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
155642|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
155643|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
155644|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
155667|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
155668|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
155645|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
155646|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
155647|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
155648|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
155649|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
155650|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
155651|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
155669|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
155670|NCT01726335|E1|Reported Event|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
155652|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
155653|NCT01726504|E2|Reported Event|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
155654|NCT01726504|E1|Reported Event|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
155655|NCT01726335|B1|Baseline|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
155656|NCT01726335|P1|Participant Flow|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
155657|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
155658|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
155659|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
155660|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
155661|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
155662|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
155663|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
155664|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
155671|NCT01726049|B3|Baseline|Total|Total of all reporting groups
155672|NCT01726049|B2|Baseline|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
162027|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
155673|NCT01726049|B1|Baseline|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
155674|NCT01726049|P2|Participant Flow|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
155675|NCT01726049|P1|Participant Flow|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
155676|NCT01726049|O2|Outcome|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
155677|NCT01726049|O1|Outcome|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
155678|NCT01726049|O2|Outcome|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
155679|NCT01726049|O1|Outcome|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
155680|NCT01726049|O2|Outcome|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
155681|NCT01726049|O1|Outcome|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
155682|NCT01726049|O2|Outcome|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
155683|NCT01726049|O1|Outcome|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
155684|NCT01726049|E2|Reported Event|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
155685|NCT01726049|E1|Reported Event|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
155686|NCT01726023|B3|Baseline|Total|Total of all reporting groups
155687|NCT01726023|B2|Baseline|Meropenem|Meropenem powder for solution for infusion 1000mg
155688|NCT01726023|B1|Baseline|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155689|NCT01726023|P2|Participant Flow|Meropenem|Meropenem powder for solution for infusion 1000mg
155690|NCT01726023|P1|Participant Flow|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155691|NCT01726023|O6|Outcome|Avibactam(3)|300-360 minutes after
155692|NCT01726023|O5|Outcome|Ceftazidime(3)|300-360 minutes after
155693|NCT01726023|O4|Outcome|Avibactam(2)|30-90 minutes after
155694|NCT01726023|O3|Outcome|Ceftazidime(2)|30-90 minutes after
155695|NCT01726023|O2|Outcome|Avibactam(1)|15 minutes before or after
155696|NCT01726023|O1|Outcome|Ceftazidime(1)|15 minutes before or after
155697|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155698|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155699|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155700|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155701|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155702|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155703|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155704|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155705|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155706|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155707|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155708|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155709|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155710|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155711|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155712|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155713|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155714|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155715|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155716|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155717|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155718|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
155719|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155763|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155720|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
155721|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155722|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
155723|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155724|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
155725|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155726|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
155727|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155728|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
155729|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155730|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
155731|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155732|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
155733|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155734|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
155735|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155736|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155737|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155738|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155739|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155740|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155741|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155742|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155743|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155744|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155745|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155746|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155747|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155748|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155749|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155750|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155751|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155752|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155753|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155754|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155755|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155756|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155757|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155758|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155759|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155760|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155761|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155762|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155764|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155765|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155766|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155767|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155768|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155769|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155770|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155771|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155772|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155773|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155774|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155775|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
155776|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
155777|NCT01726023|E2|Reported Event|Meropenem|Meropenem powder for solution for infusion 1000mg
155778|NCT01726023|E1|Reported Event|CAZ-AVI Plus Metronidazole|
155779|NCT01725984|B3|Baseline|Total|Total of all reporting groups
155780|NCT01725984|B2|Baseline|AdVance XP|Subjects previously implanted with the AdVance XP male sling
155781|NCT01725984|B1|Baseline|AdVance|Subjects previously implanted with the AdVance Male Sling
155782|NCT01725984|P2|Participant Flow|AdVance XP|Subjects previously implanted with the AdVance XP male sling
155783|NCT01725984|P1|Participant Flow|AdVance|Subjects previously implanted with the AdVance Male Sling
155784|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
155785|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
155786|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
155787|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
155788|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
155789|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
155790|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
155791|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
155792|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
155793|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
155794|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
155795|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
155796|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
155797|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
155798|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
155799|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
155800|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
155801|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
155802|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
155803|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
155804|NCT01725984|E2|Reported Event|AdVance XP|Subjects implanted with the AdVance XP Male Sling
155805|NCT01725984|E1|Reported Event|AdVance|Subjects implanted with the AdVance Male Sling
155806|NCT01725529|B4|Baseline|Total|Total of all reporting groups
155807|NCT01725529|B3|Baseline|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
155808|NCT01725529|B2|Baseline|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
155809|NCT01725529|B1|Baseline|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
155810|NCT01725529|P3|Participant Flow|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
155849|NCT01725451|O5|Outcome|Testosterone Shaved|No deodorant or antiperspirant. A single 30-mg dose of testosterone 2% solution applied topically to each shaved axilla.
156737|NCT01721486|O1|Outcome|Study Group|IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion after IV placement in OR in study group only.
155811|NCT01725529|P2|Participant Flow|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
155812|NCT01725529|P1|Participant Flow|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
155813|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
155814|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
155815|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
155816|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
155817|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
155818|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
155819|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
155820|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
155821|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
155822|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
155823|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
155824|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
155825|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
155826|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
155827|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
155828|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
155829|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
155830|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
155831|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
173033|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
155832|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
155833|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
155834|NCT01725529|E3|Reported Event|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
155835|NCT01725529|E2|Reported Event|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
155836|NCT01725529|E1|Reported Event|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
155837|NCT01725451|B1|Baseline|Testosterone 2% Solution|Participants randomized to 1 of 4 treatment sequences involving 6 treatments in each sequence. Each sequence involved 4 single-dose treatments of testosterone 2% solution to unshaved axillae with or without the use of deodorant or antiperspirant products followed by 2 single-dose treatments of testosterone 2% solution to shaved axillae with or without the use of deodorant or antiperspirant products. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
155838|NCT01725451|P4|Participant Flow|Sequence 4|30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
155839|NCT01725451|P3|Participant Flow|Sequence 3|30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
155840|NCT01725451|P2|Participant Flow|Sequence 2|30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 5, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
155841|NCT01725451|P1|Participant Flow|Sequence 1|30-milligram (mg) testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
155842|NCT01725451|O6|Outcome|Testosterone Shaved + Deodorant Antiperspirant Spray|Deodorant/antiperspirant combination spray applied to each shaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
155843|NCT01725451|O5|Outcome|Testosterone Shaved|No deodorant or antiperspirant. A single 30-mg dose of testosterone 2% solution applied topically to each shaved axilla.
155844|NCT01725451|O4|Outcome|Testosterone Unshaved + Deodorant Antiperspirant Stick|Deodorant/antiperspirant combination stick applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
155845|NCT01725451|O3|Outcome|Testosterone Unshaved + Deodorant Antiperspirant Spray|Deodorant antiperspirant combination spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution .
155846|NCT01725451|O2|Outcome|Testosterone Unshaved + Deodorant Spray|Deodorant spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
155847|NCT01725451|O1|Outcome|Testosterone Unshaved|No deodorant or antiperspirant. A single 30-milligram (mg) dose of testosterone 2% solution applied topically to each unshaved axilla.
155848|NCT01725451|O6|Outcome|Testosterone Shaved + Deodorant Antiperspirant Spray|Deodorant/antiperspirant combination spray applied to each shaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
155850|NCT01725451|O4|Outcome|Testosterone Unshaved + Deodorant Antiperspirant Stick|Deodorant/antiperspirant combination stick applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
155851|NCT01725451|O3|Outcome|Testosterone Unshaved + Deodorant Antiperspirant Spray|Deodorant antiperspirant combination spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
155852|NCT01725451|O2|Outcome|Testosterone Unshaved + Deodorant Spray|Deodorant spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
155853|NCT01725451|O1|Outcome|Testosterone Unshaved|No deodorant or antiperspirant. A single 30-milligram (mg) dose of testosterone 2% solution applied topically to each unshaved axilla.
155854|NCT01725451|E6|Reported Event|Testosterone Shaved + Deodorant Antiperspirant Spray|Deodorant/antiperspirant combination spray applied to each shaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
155855|NCT01725451|E5|Reported Event|Testosterone Shaved|No deodorant or antiperspirant. A single 30-mg dose of testosterone 2% solution applied topically to each shaved axilla.
155856|NCT01725451|E4|Reported Event|Testosterone Unshaved + Deodorant Antiperspirant Stick|Deodorant/antiperspirant combination stick applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
155857|NCT01725451|E3|Reported Event|Testosterone Unshaved + Deodorant Antiperspirant Spray|Deodorant antiperspirant combination spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
155858|NCT01725451|E2|Reported Event|Testosterone Unshaved + Deodorant Spray|Deodorant spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
155859|NCT01725451|E1|Reported Event|Testosterone Unshaved|No deodorant or antiperspirant. A single 30-milligram (mg) dose of testosterone 2% solution applied topically to each unshaved axilla.
155860|NCT01725386|B3|Baseline|Total|Total of all reporting groups
155861|NCT01725386|B2|Baseline|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
155862|NCT01725386|B1|Baseline|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
155863|NCT01725386|P2|Participant Flow|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
155864|NCT01725386|P1|Participant Flow|Monotherapy|Capecitabine (XELODA®) as monotherapy according to prescribing information and normal clinical practice.
155865|NCT01725386|O2|Outcome|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
155866|NCT01725386|O1|Outcome|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
155867|NCT01725386|O2|Outcome|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
155868|NCT01725386|O1|Outcome|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
155869|NCT01725386|O2|Outcome|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
155870|NCT01725386|O1|Outcome|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
155871|NCT01725386|O2|Outcome|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
155872|NCT01725386|O1|Outcome|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
155873|NCT01725386|O2|Outcome|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
155874|NCT01725386|O1|Outcome|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
155875|NCT01725386|O2|Outcome|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
155876|NCT01725386|O1|Outcome|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
155877|NCT01725386|E2|Reported Event|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
155878|NCT01725386|E1|Reported Event|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
155879|NCT01725308|B4|Baseline|Total|Total of all reporting groups
155880|NCT01725308|B3|Baseline|FK949E 300 mg|After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155881|NCT01725308|B2|Baseline|FK949E 150 mg|After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155882|NCT01725308|B1|Baseline|Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155883|NCT01725308|P3|Participant Flow|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155884|NCT01725308|P2|Participant Flow|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155885|NCT01725308|P1|Participant Flow|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155886|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155887|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155888|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155889|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155890|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155891|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155892|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155893|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155894|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
156833|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
155895|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155896|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155897|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155898|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155899|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155900|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155901|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155902|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155903|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155904|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155905|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
156906|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
155906|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155907|NCT01725308|O3|Outcome|FK949E 300 mg|After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155908|NCT01725308|O2|Outcome|FK949E 150 mg|After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155909|NCT01725308|O1|Outcome|Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155910|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155911|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155912|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155913|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155914|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155915|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155916|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155917|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
156907|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
155918|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155919|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155920|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155921|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155922|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155923|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155924|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155925|NCT01725308|O3|Outcome|FK949E 300 mg|After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155926|NCT01725308|O2|Outcome|FK949E 150 mg|After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155927|NCT01725308|O1|Outcome|Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155928|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155929|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
156908|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
155930|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155931|NCT01725308|O3|Outcome|FK949E 300 mg|After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155932|NCT01725308|O2|Outcome|FK949E 150 mg|After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155933|NCT01725308|O1|Outcome|Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155934|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155935|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155936|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155937|NCT01725308|O3|Outcome|FK949E 300 mg|After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155938|NCT01725308|O2|Outcome|FK949E 150 mg|After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155939|NCT01725308|O1|Outcome|Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155940|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155941|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155942|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
157388|NCT01720251|P1|Participant Flow|Placebo|"SC injections of placebo~placebo: SC injections of placebo on days 1, 7, 14, 28 and 56"
155943|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155944|NCT01725308|O2|Outcome|FK949E 150 mg|After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155945|NCT01725308|O1|Outcome|Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155946|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155947|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155948|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155949|NCT01725308|O3|Outcome|FK949E 300 mg|After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155950|NCT01725308|O2|Outcome|FK949E 150 mg|After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155951|NCT01725308|O1|Outcome|Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155952|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155953|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155954|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155955|NCT01725308|O3|Outcome|FK949E 300 mg|After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
156052|NCT01725282|O4|Outcome|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
155956|NCT01725308|O2|Outcome|FK949E 150 mg|After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155957|NCT01725308|O1|Outcome|Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155958|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155959|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155960|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155961|NCT01725308|O3|Outcome|FK949E 300 mg|After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155962|NCT01725308|O2|Outcome|FK949E 150 mg|After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155963|NCT01725308|O1|Outcome|Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155964|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155965|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155966|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155967|NCT01725308|O3|Outcome|FK949E 300 mg|After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155968|NCT01725308|O2|Outcome|FK949E 150 mg|After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
156053|NCT01725282|O3|Outcome|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
155969|NCT01725308|O1|Outcome|Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155970|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155971|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155972|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155973|NCT01725308|O3|Outcome|FK949E 300 mg|After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155974|NCT01725308|O2|Outcome|FK949E 150 mg|After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155975|NCT01725308|O1|Outcome|Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155976|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155977|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155978|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155979|NCT01725308|O3|Outcome|FK949E 300 mg|After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155980|NCT01725308|O2|Outcome|FK949E 150 mg|After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155981|NCT01725308|O1|Outcome|Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
156054|NCT01725282|O2|Outcome|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
156055|NCT01725282|O1|Outcome|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
155982|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155983|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155984|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155985|NCT01725308|O3|Outcome|FK949E 300 mg|After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155986|NCT01725308|O2|Outcome|FK949E 150 mg|After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155987|NCT01725308|O1|Outcome|Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155988|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155989|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155990|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155991|NCT01725308|O3|Outcome|FK949E 300 mg|After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155992|NCT01725308|O2|Outcome|FK949E 150 mg|After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155993|NCT01725308|O1|Outcome|Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155994|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
157496|NCT01719003|O6|Outcome|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
155995|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155996|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
155997|NCT01725308|O3|Outcome|FK949E 300 mg|After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155998|NCT01725308|O2|Outcome|FK949E 150 mg|After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
155999|NCT01725308|O1|Outcome|Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
156000|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
156001|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
156002|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
156003|NCT01725308|O3|Outcome|FK949E 300 mg|After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
156004|NCT01725308|O2|Outcome|FK949E 150 mg|After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
156005|NCT01725308|O1|Outcome|Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
156006|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
156007|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
162028|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
156008|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
156009|NCT01725308|O3|Outcome|FK949E 300 mg|After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
156010|NCT01725308|O2|Outcome|FK949E 150 mg|After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
156011|NCT01725308|O1|Outcome|Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
156012|NCT01725308|O3|Outcome|FK949E 300 mg / FK949E|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
156013|NCT01725308|O2|Outcome|FK949E 150 mg / FK949E|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
156014|NCT01725308|O1|Outcome|Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
156015|NCT01725308|O3|Outcome|FK949E 300 mg|After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
156016|NCT01725308|O2|Outcome|FK949E 150 mg|After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
156017|NCT01725308|O1|Outcome|Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
156018|NCT01725308|O3|Outcome|FK949E 300 mg|After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
156019|NCT01725308|O2|Outcome|FK949E 150 mg|After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
156020|NCT01725308|O1|Outcome|Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
156021|NCT01725308|E6|Reported Event|Treatment Period I + II: FK949E 300 mg / FK949E|Participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
162029|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
156022|NCT01725308|E5|Reported Event|Treatment Period I + II: FK949E 150 mg / FK949E|Participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
156023|NCT01725308|E4|Reported Event|Treatment Period I + II: Placebo / FK949E|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
156024|NCT01725308|E3|Reported Event|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
156025|NCT01725308|E2|Reported Event|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
156026|NCT01725308|E1|Reported Event|Treatment Period I: Placebo|Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
156027|NCT01725282|B5|Baseline|Total|Total of all reporting groups
156028|NCT01725282|B4|Baseline|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
156029|NCT01725282|B3|Baseline|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
156030|NCT01725282|B2|Baseline|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
156031|NCT01725282|B1|Baseline|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
156032|NCT01725282|P4|Participant Flow|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
156033|NCT01725282|P3|Participant Flow|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
156034|NCT01725282|P2|Participant Flow|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
156035|NCT01725282|P1|Participant Flow|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
156036|NCT01725282|O4|Outcome|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
156037|NCT01725282|O3|Outcome|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
156038|NCT01725282|O2|Outcome|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
156039|NCT01725282|O1|Outcome|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
156040|NCT01725282|O4|Outcome|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
156041|NCT01725282|O3|Outcome|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
156042|NCT01725282|O2|Outcome|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
156043|NCT01725282|O1|Outcome|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
156044|NCT01725282|O4|Outcome|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
156045|NCT01725282|O3|Outcome|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
156046|NCT01725282|O2|Outcome|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
156047|NCT01725282|O1|Outcome|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
156048|NCT01725282|O4|Outcome|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
156049|NCT01725282|O3|Outcome|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
156050|NCT01725282|O2|Outcome|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
156051|NCT01725282|O1|Outcome|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
156909|NCT01721161|E2|Reported Event|BIIB033 100 mg/kg|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
156056|NCT01725282|O4|Outcome|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
156057|NCT01725282|O3|Outcome|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
156058|NCT01725282|O2|Outcome|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
156059|NCT01725282|O1|Outcome|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
156060|NCT01725282|E4|Reported Event|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
156061|NCT01725282|E3|Reported Event|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
156062|NCT01725282|E2|Reported Event|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
156063|NCT01725282|E1|Reported Event|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
156064|NCT01725217|B4|Baseline|Total|Total of all reporting groups
156065|NCT01725217|B3|Baseline|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
156066|NCT01725217|B2|Baseline|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
156067|NCT01725217|B1|Baseline|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
156068|NCT01725217|P3|Participant Flow|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
156069|NCT01725217|P2|Participant Flow|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
156070|NCT01725217|P1|Participant Flow|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
156071|NCT01725217|O4|Outcome|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
156072|NCT01725217|O3|Outcome|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
156073|NCT01725217|O2|Outcome|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
156074|NCT01725217|O1|Outcome|Overall (≥2 Years)|All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
156075|NCT01725217|O4|Outcome|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
156076|NCT01725217|O3|Outcome|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
156077|NCT01725217|O2|Outcome|≥6 to ≤10 Years|Subjects ≥6 to ≤10 years of age who received one vaccination of MenACWY-CRM
156078|NCT01725217|O1|Outcome|Overall (≥6 Years)|All subjects ≥6 years of age who received one vaccination of MenACWY-CRM
156079|NCT01725217|O2|Outcome|≥2 to ≤3 Years|Subjects ≥2 to ≤3 years of age who received one vaccination of MenACWY-CRM
156080|NCT01725217|O1|Outcome|≥2 to ≤5 Years|Subjects ≥2 to ≤5 years of age who received one vaccination of MenACWY-CRM
156081|NCT01725217|O4|Outcome|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
156082|NCT01725217|O3|Outcome|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
156083|NCT01725217|O2|Outcome|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
156084|NCT01725217|O1|Outcome|Overall (≥2 Years)|All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
156085|NCT01725217|O4|Outcome|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
156086|NCT01725217|O3|Outcome|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
156087|NCT01725217|O2|Outcome|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
156088|NCT01725217|O1|Outcome|Overall (≥2 Years)|All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
156089|NCT01725217|O3|Outcome|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
156090|NCT01725217|O2|Outcome|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
156091|NCT01725217|O1|Outcome|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
156092|NCT01725217|O1|Outcome|Overall (≥2 Years)|All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
156093|NCT01725217|E4|Reported Event|Overall (≥2 Years)|All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
156094|NCT01725217|E3|Reported Event|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
156095|NCT01725217|E2|Reported Event|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
156096|NCT01725217|E1|Reported Event|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
156097|NCT01725126|B7|Baseline|Total|Total of all reporting groups
156098|NCT01725126|B6|Baseline|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156312|NCT01724528|O1|Outcome|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
156910|NCT01721161|E1|Reported Event|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
156099|NCT01725126|B5|Baseline|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156100|NCT01725126|B4|Baseline|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156101|NCT01725126|B3|Baseline|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 milligram (mg) once daily by subcutaneous injection during the Treatment period along with placebo.
156102|NCT01725126|B2|Baseline|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
156103|NCT01725126|B1|Baseline|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
156104|NCT01725126|P6|Participant Flow|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156105|NCT01725126|P5|Participant Flow|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156106|NCT01725126|P4|Participant Flow|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156107|NCT01725126|P3|Participant Flow|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 milligram (mg) once daily by subcutaneous injection during the Treatment period along with placebo.
156313|NCT01724528|O2|Outcome|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
156108|NCT01725126|P2|Participant Flow|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
156109|NCT01725126|P1|Participant Flow|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 gram (g) kit twice daily (BID) for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 milliliter (mL) of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) prior to breakfast (morning) and 10 g (2 unit) prior to dinner (evening). On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 milligram (mg) immediate release (IR) tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
156110|NCT01725126|O2|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156111|NCT01725126|O1|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156112|NCT01725126|O2|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156113|NCT01725126|O1|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156114|NCT01725126|O2|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156115|NCT01725126|O1|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156116|NCT01725126|O2|Outcome|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
157497|NCT01719003|O5|Outcome|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
156117|NCT01725126|O1|Outcome|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) prior to breakfast (morning) and 10 g (2 unit) prior to dinner (evening). On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
156118|NCT01725126|O2|Outcome|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
156119|NCT01725126|O1|Outcome|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) prior to breakfast (morning) and 10 g (2 unit) prior to dinner (evening). On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
156120|NCT01725126|O2|Outcome|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
156121|NCT01725126|O1|Outcome|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) prior to breakfast (morning) and 10 g (2 unit) prior to dinner (evening). On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
156122|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156123|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156124|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156125|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
157498|NCT01719003|O4|Outcome|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
156126|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156127|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156128|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156129|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156130|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156131|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156132|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156133|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156134|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156314|NCT01724528|O1|Outcome|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
156645|NCT01722045|O1|Outcome|Open Label IAI|2 mg IAI (Intravitreal Aflibercept Injection) at 4-week intervals (2Q4) up to week 8 for a total of 3 injections, and 2 mg at 8-week intervals (2Q8) thereafter until week 96
156135|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156136|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156137|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156138|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156139|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156140|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156141|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156142|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156143|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156315|NCT01724528|O2|Outcome|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
157505|NCT01719003|O5|Outcome|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
156144|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156145|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156146|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156147|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156148|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156149|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156150|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156151|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156152|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156316|NCT01724528|O1|Outcome|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
157111|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
156153|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156154|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156155|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156156|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156157|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156158|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156159|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156160|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156161|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156317|NCT01724528|O2|Outcome|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
157556|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
156162|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156163|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156164|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156165|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156166|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156167|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156168|NCT01725126|O2|Outcome|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
156169|NCT01725126|O1|Outcome|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
156170|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156318|NCT01724528|O1|Outcome|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
157628|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
156171|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156172|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156173|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156174|NCT01725126|O2|Outcome|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
156175|NCT01725126|O1|Outcome|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
156176|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156177|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156178|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156179|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156319|NCT01724528|E2|Reported Event|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
156180|NCT01725126|O2|Outcome|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
156181|NCT01725126|O1|Outcome|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
156182|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156183|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156184|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156185|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156186|NCT01725126|O2|Outcome|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
156187|NCT01725126|O1|Outcome|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
156188|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 1 5g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156320|NCT01724528|E1|Reported Event|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
156189|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156190|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156191|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156192|NCT01725126|O2|Outcome|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
156193|NCT01725126|O1|Outcome|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
156194|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156195|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156196|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156197|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156321|NCT01724359|B1|Baseline|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
173034|NCT01665170|O1|Outcome|Placebo|Placebo arm
156198|NCT01725126|O2|Outcome|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
156199|NCT01725126|O1|Outcome|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
156200|NCT01725126|O2|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156201|NCT01725126|O1|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156202|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156203|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156204|NCT01725126|O2|Outcome|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
156205|NCT01725126|O1|Outcome|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) prior to breakfast (morning) and 10 g (2 unit) prior to dinner (evening). On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg immediate release (IR) tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
156206|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156646|NCT01722045|E1|Reported Event|Open Label IAI|2 mg IAI (Intravitreal Aflibercept Injection) at 4-week intervals (2Q4) up to week 8 for a total of 3 injections, and 2 mg at 8-week intervals (2Q8) thereafter until week 96
156207|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156208|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156209|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156210|NCT01725126|O2|Outcome|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
156211|NCT01725126|O1|Outcome|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
156212|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156213|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156214|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156215|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156322|NCT01724359|P1|Participant Flow|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
156216|NCT01725126|O2|Outcome|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
156217|NCT01725126|O1|Outcome|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
156218|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156219|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156220|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156221|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156222|NCT01725126|O2|Outcome|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
156223|NCT01725126|O1|Outcome|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
156224|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156323|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
156225|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156226|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156227|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156228|NCT01725126|O2|Outcome|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
156229|NCT01725126|O1|Outcome|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
156230|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156231|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156232|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156233|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156324|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
156647|NCT01721967|B1|Baseline|Ranolazine|Ranolazine, 500 mg for 60 days
156234|NCT01725126|O2|Outcome|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
156235|NCT01725126|O1|Outcome|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
156236|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156237|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156238|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156239|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156240|NCT01725126|O2|Outcome|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
156241|NCT01725126|O1|Outcome|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
156242|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156325|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
156243|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156244|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156245|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156246|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156247|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156248|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156249|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156250|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156251|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156326|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
156648|NCT01721967|P1|Participant Flow|Ranolazine|Ranolazine, 500 mg for 60 days
156252|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156253|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156254|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156255|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156256|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156257|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156258|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156259|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156260|NCT01725126|O2|Outcome|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
156327|NCT01724359|O2|Outcome|Patients at Week 26: Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
156649|NCT01721967|O1|Outcome|Ranolazine|Ranolazine, 500 mg for 60 days
156261|NCT01725126|O1|Outcome|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
156262|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156263|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156264|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156265|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156266|NCT01725126|O2|Outcome|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
156267|NCT01725126|O1|Outcome|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
156268|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156269|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo as once daily or BID.
156328|NCT01724359|O1|Outcome|Patients at Baseline: Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
156270|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156271|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156272|NCT01725126|O2|Outcome|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
156273|NCT01725126|O1|Outcome|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
156274|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156275|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156276|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156277|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156278|NCT01725126|O2|Outcome|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
156329|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
156650|NCT01721967|O1|Outcome|Ranolazine|Ranolazine, 500 mg for 60 days
156279|NCT01725126|O1|Outcome|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
156280|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156281|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156282|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156283|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156284|NCT01725126|O2|Outcome|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
156285|NCT01725126|O1|Outcome|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
156286|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15g to 40g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156287|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156330|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
156288|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156289|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156290|NCT01725126|O2|Outcome|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
156291|NCT01725126|O1|Outcome|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
156292|NCT01725126|O4|Outcome|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156293|NCT01725126|O3|Outcome|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156294|NCT01725126|O2|Outcome|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156295|NCT01725126|O1|Outcome|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 milligram (mg) once daily by subcutaneous injection during the Treatment period along with placebo.
156296|NCT01725126|O2|Outcome|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
156331|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
156297|NCT01725126|O1|Outcome|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
156298|NCT01725126|E6|Reported Event|Part C-GSK2890457+Metformin|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
156299|NCT01725126|E5|Reported Event|Part C-Placebo+Metformin|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
156300|NCT01725126|E4|Reported Event|Part B-GSK2890457+Liraglutide|Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
156301|NCT01725126|E3|Reported Event|Part B-Placebo+Liraglutide|Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with placebo.
156302|NCT01725126|E2|Reported Event|Part A-GSK2890457|Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
156303|NCT01725126|E1|Reported Event|Part A-Placebo|Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID or 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) prior to breakfast (morning) and 10 g (2 unit) prior to dinner (evening). On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
156304|NCT01724528|B3|Baseline|Total|Total of all reporting groups
156305|NCT01724528|B2|Baseline|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
156306|NCT01724528|B1|Baseline|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
156307|NCT01724528|P2|Participant Flow|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
156308|NCT01724528|P1|Participant Flow|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
156309|NCT01724528|O2|Outcome|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
156310|NCT01724528|O1|Outcome|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
156311|NCT01724528|O2|Outcome|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
156332|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
156333|NCT01724359|E1|Reported Event|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
156334|NCT01724216|B1|Baseline|Single Arm|Magnetic Resonance Image Collection Using Innovative Pulse Sequences
156335|NCT01724216|P1|Participant Flow|Single Arm|Magnetic Resonance Images Collected Using Innovative Pulse Sequences :
156336|NCT01724216|O1|Outcome|Single Arm|Magnetic Resonance Imaging Using Innovative Pulse Sequences :
156337|NCT01724216|E1|Reported Event|Single Arm|Magnetic Resonance Imaging Using Innovative Pulse Sequences :
156338|NCT01724177|B1|Baseline|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity.
156339|NCT01724177|P1|Participant Flow|Lenalidomide|Lenalidomide 25 mg administered by mouth (PO) once daily (QD) until progressive disease or unacceptable toxicity
156340|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
156341|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
156342|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
156343|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered by mouth (PO) once daily (QD) until progressive disease or unacceptable toxicity
156344|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
156345|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
156346|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
156347|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
156348|NCT01724177|E1|Reported Event|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
156349|NCT01724021|B3|Baseline|Total|Total of all reporting groups
156350|NCT01724021|B2|Baseline|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156351|NCT01724021|B1|Baseline|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156352|NCT01724021|P2|Participant Flow|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156353|NCT01724021|P1|Participant Flow|Arm A|Participants in Arm A received one cycle of rituximab 375 milligram per metre square (mg/m^2) intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156354|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156355|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156356|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156370|NCT01724021|O2|Outcome|Rituximab Subcutaneous (SC)|Each treatment cycle consisted of a single SC injection of rituximab administered at a fixed dose of 1400 mg. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156651|NCT01721967|O1|Outcome|Ranolazine|Ranolazine, 500 mg for 60 days
156652|NCT01721967|O1|Outcome|Ranolazine|Ranolazine, 500 mg for 60 days
156357|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156358|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156359|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156360|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156361|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156362|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156363|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156364|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156365|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156366|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156367|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156368|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156369|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156653|NCT01721967|O1|Outcome|Ranolazine|Ranolazine, 500 mg for 60 days
156371|NCT01724021|O1|Outcome|Rituximab Intravenous (IV)|Rituximab was administered at a dose of 375 mg/m2 body surface area (BSA) as a single IV infusion, followed by administration of chemotherapy. At Cycle 1, Day 1, the first rituximab dose for both Arms A and B was always administered as a slow IV infusion, according to local standard practice. Faster infusion rates were permitted after Cycle 1, according to local practice. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156372|NCT01724021|O2|Outcome|Rituximab Subcutaneous (SC)|Each treatment cycle consisted of a single SC injection of rituximab administered at a fixed dose of 1400 mg. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156373|NCT01724021|O1|Outcome|Rituximab Intravenous (IV)|Rituximab was administered at a dose of 375 mg/m2 body surface area (BSA) as a single IV infusion, followed by administration of chemotherapy. At Cycle 1, Day 1, the first rituximab dose for both Arms A and B was always administered as a slow IV infusion, according to local standard practice. Faster infusion rates were permitted after Cycle 1, according to local practice. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156374|NCT01724021|O2|Outcome|Rituximab Subcutaneous (SC)|Each treatment cycle consisted of a single SC injection of rituximab administered at a fixed dose of 1400 mg. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156375|NCT01724021|O1|Outcome|Rituximab Intravenous (IV)|Rituximab was administered at a dose of 375 mg/m2 body surface area (BSA) as a single IV infusion, followed by administration of chemotherapy. At Cycle 1, Day 1, the first rituximab dose for both Arms A and B was always administered as a slow IV infusion, according to local standard practice. Faster infusion rates were permitted after Cycle 1, according to local practice. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156376|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156377|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156378|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156379|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156380|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156381|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156382|NCT01724021|E2|Reported Event|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156383|NCT01724021|E1|Reported Event|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
156397|NCT01723722|P2|Participant Flow|Deodorized Tincture Opium After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started dilute deordorized tincture of opium
156654|NCT01721967|O1|Outcome|Ranolazine|Ranolazine, 500 mg for 60 days
156655|NCT01721967|E1|Reported Event|Ranolazine|Ranolazine, 500 mg for 60 days
156384|NCT01723904|B1|Baseline|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
156385|NCT01723904|P1|Participant Flow|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
156386|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
156387|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
156388|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
156389|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
156390|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
156391|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
156392|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
156393|NCT01723904|E1|Reported Event|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
156394|NCT01723722|B3|Baseline|Total|Total of all reporting groups
156395|NCT01723722|B2|Baseline|DTO After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started dilute deordorized tincture of opium
156396|NCT01723722|B1|Baseline|Methadone After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started methadone
157629|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
156398|NCT01723722|P1|Participant Flow|Methadone After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started methadone
156399|NCT01723722|O2|Outcome|Methadone After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started methadone
156400|NCT01723722|O1|Outcome|Deodorized Tincture Opium After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started dilute deordorized tincture of opium
156401|NCT01723722|E2|Reported Event|DTO After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started dilute deordorized tincture of opium
156402|NCT01723722|E1|Reported Event|Methadone After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started methadone
156403|NCT01723397|B3|Baseline|Total|Total of all reporting groups
156404|NCT01723397|B2|Baseline|Placebo Spray, Then Nasaleze Spray|"This group first received placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge"
156405|NCT01723397|B1|Baseline|Nasaleze Spray, Then Placebo Spray|"This group first received Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge"
156406|NCT01723397|P2|Participant Flow|Placebo Spray, Then Nasaleze Spray|"This group first received Placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen (grass or ragweed) challenge, followed by a 1 week washout and then received Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge"
156407|NCT01723397|P1|Participant Flow|Nasaleze Spray, Then Placebo Spray|"This group first received Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge"
156408|NCT01723397|O2|Outcome|Placebo Spray|"Placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge~Placebo spray: Subjects are treated with placebo nasal spray then challenged with allergen~Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo"
156409|NCT01723397|O1|Outcome|Nasaleze Spray|"Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge~Nasaleze Spray: Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen~Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo"
156410|NCT01723397|E2|Reported Event|Placebo Spray|"Placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge~Placebo spray: Subjects are treated with placebo nasal spray then challenged with allergen~Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo"
156411|NCT01723397|E1|Reported Event|Nasaleze Spray|"Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge~Nasaleze Spray: Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen~Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo"
156412|NCT01723254|B9|Baseline|Total|Total of all reporting groups
156413|NCT01723254|B8|Baseline|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
156414|NCT01723254|B7|Baseline|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
156415|NCT01723254|B6|Baseline|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
156416|NCT01723254|B5|Baseline|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
156417|NCT01723254|B4|Baseline|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
156418|NCT01723254|B3|Baseline|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
156419|NCT01723254|B2|Baseline|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
156420|NCT01723254|B1|Baseline|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
156421|NCT01723254|P8|Participant Flow|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
156422|NCT01723254|P7|Participant Flow|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
156423|NCT01723254|P6|Participant Flow|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
156424|NCT01723254|P5|Participant Flow|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
156425|NCT01723254|P4|Participant Flow|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
156426|NCT01723254|P3|Participant Flow|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
156427|NCT01723254|P2|Participant Flow|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
156428|NCT01723254|P1|Participant Flow|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
156429|NCT01723254|O8|Outcome|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
156430|NCT01723254|O7|Outcome|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156431|NCT01723254|O6|Outcome|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156432|NCT01723254|O5|Outcome|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156433|NCT01723254|O4|Outcome|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156495|NCT01723228|E1|Reported Event|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
156434|NCT01723254|O3|Outcome|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156435|NCT01723254|O2|Outcome|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156436|NCT01723254|O1|Outcome|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156437|NCT01723254|O8|Outcome|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
156438|NCT01723254|O7|Outcome|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156439|NCT01723254|O6|Outcome|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156440|NCT01723254|O5|Outcome|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156441|NCT01723254|O4|Outcome|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156442|NCT01723254|O3|Outcome|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156443|NCT01723254|O2|Outcome|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156444|NCT01723254|O1|Outcome|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156445|NCT01723254|O8|Outcome|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
156446|NCT01723254|O7|Outcome|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156447|NCT01723254|O6|Outcome|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156448|NCT01723254|O5|Outcome|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156449|NCT01723254|O4|Outcome|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156450|NCT01723254|O3|Outcome|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156451|NCT01723254|O2|Outcome|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156452|NCT01723254|O1|Outcome|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156453|NCT01723254|O8|Outcome|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
156454|NCT01723254|O7|Outcome|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156455|NCT01723254|O6|Outcome|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156456|NCT01723254|O5|Outcome|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156457|NCT01723254|O4|Outcome|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156458|NCT01723254|O3|Outcome|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156459|NCT01723254|O2|Outcome|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156460|NCT01723254|O1|Outcome|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156461|NCT01723254|O8|Outcome|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
156462|NCT01723254|O7|Outcome|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156463|NCT01723254|O6|Outcome|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156464|NCT01723254|O5|Outcome|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156465|NCT01723254|O4|Outcome|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156466|NCT01723254|O3|Outcome|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156467|NCT01723254|O2|Outcome|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156468|NCT01723254|O1|Outcome|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
156469|NCT01723254|E8|Reported Event|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
156470|NCT01723254|E7|Reported Event|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
156471|NCT01723254|E6|Reported Event|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
156472|NCT01723254|E5|Reported Event|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
156473|NCT01723254|E4|Reported Event|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
156474|NCT01723254|E3|Reported Event|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
156475|NCT01723254|E2|Reported Event|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
156476|NCT01723254|E1|Reported Event|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
156477|NCT01723228|B3|Baseline|Total|Total of all reporting groups
156478|NCT01723228|B2|Baseline|Placebo|Placebo oral tablets once daily for 24 weeks
156479|NCT01723228|B1|Baseline|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
156480|NCT01723228|P2|Participant Flow|Placebo|Placebo oral tablets once daily for 24 weeks
156481|NCT01723228|P1|Participant Flow|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
156482|NCT01723228|O2|Outcome|Placebo|Placebo oral tablets once daily for 24 weeks
156483|NCT01723228|O1|Outcome|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
156484|NCT01723228|O2|Outcome|Placebo|Placebo oral tablets once daily for 24 weeks
156485|NCT01723228|O1|Outcome|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
156486|NCT01723228|O2|Outcome|Placebo|Placebo oral tablets once daily for 24 weeks
156487|NCT01723228|O1|Outcome|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
156488|NCT01723228|O2|Outcome|Placebo|Placebo oral tablets once daily for 24 weeks
156489|NCT01723228|O1|Outcome|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
156490|NCT01723228|O2|Outcome|Placebo|Placebo oral tablets once daily for 24 weeks
156491|NCT01723228|O1|Outcome|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
156492|NCT01723228|O2|Outcome|Placebo|Placebo oral tablets once daily for 24 weeks
156493|NCT01723228|O1|Outcome|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
156494|NCT01723228|E2|Reported Event|Placebo|Placebo oral tablets once daily for 24 weeks
156497|NCT01722994|B2|Baseline|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
156498|NCT01722994|B1|Baseline|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
156499|NCT01722994|P2|Participant Flow|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
156500|NCT01722994|P1|Participant Flow|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
156501|NCT01722994|O2|Outcome|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
156502|NCT01722994|O1|Outcome|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
156503|NCT01722994|O2|Outcome|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
156504|NCT01722994|O1|Outcome|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
156505|NCT01722994|O2|Outcome|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
156506|NCT01722994|O1|Outcome|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
156507|NCT01722994|O2|Outcome|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
156508|NCT01722994|O1|Outcome|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
156509|NCT01722994|O2|Outcome|Group 2 Punch Biopsy Wound|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
156510|NCT01722994|O1|Outcome|Group 1 Punch Biopsy Wound|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
156511|NCT01722994|E2|Reported Event|Group 2 Punch Biopsy Wound|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
156512|NCT01722994|E1|Reported Event|Group 1 Punch Biopsy Wound|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
156513|NCT01722929|B1|Baseline|Surgery Side and Non-surgery Side|All study participants had the skin sensor placed near the site of their surgery wound, and also on a site without any surgery wound.
156514|NCT01722929|P1|Participant Flow|Surgery Side and Non-surgery Side|"This is a split-body, parallel-designed study. All study participants had the skin sensor (the same intervention) placed near the site of their surgery wound, and also on a site without any surgery wound.~Since this is split-body design with one intervention, participant flow will be limited to all study participants as one group to not double-count the number of participants."
156515|NCT01722929|O2|Outcome|Skin Sensor on Non-surgery Side|"Skin sensor will be placed on the contralateral side from surgery site.~Sensor on non-surgery side~This is a split-body study. All participants will have the skin senor on both the surgery side and a non-surgery side."
156516|NCT01722929|O1|Outcome|Skin Sensor on Surgery Side|"Skin sensor will be placed on the side that had surgery.~Sensor on surgery side.~This is a split-body study. All participants will have the skin senor on both the surgery side and a non-surgery side."
156517|NCT01722929|E1|Reported Event|Surgery Side and Non-surgery Side|"The skin sensor intervention was placed on both a surgery site and a non-surgery site in the same participant. This reflects all participants that received the intervention. The Arms/Groups Surgery Side and Non-surgery Side are combined because they both received the same intervention (skin sensor)."
156518|NCT01722877|B1|Baseline|JetStream Atherectomy|Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery. Patients were eligible for the study only if they had a more or equal 50% in-stent restenotic lesion in the superficial femoral or popliteal arteries (estimated diameter ≥5 mm), Rutherford category 1-5 ischemia, and at least one patent infrapopliteal runoff vessel. Patients were excluded if they were not able to give informed consent, had a creatinine level >2.5 mg/dL, were unable to take antiplatelet drugs, or had a planned surgical or endovascular procedure within 15 days of the index procedure.The JetStream was used as a first modality of treatment, no other debulking devices, cutting/scoring balloons, or cryogenic balloons were allowed.
156519|NCT01722877|P1|Participant Flow|JetStream Atherectomy|Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.
156520|NCT01722877|O1|Outcome|JetStream Atherectomy|Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.
156521|NCT01722877|O1|Outcome|JetStream Atherectomy|Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.
173035|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
156522|NCT01722877|O1|Outcome|JetStream Atherectomy|Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.
156523|NCT01722877|O1|Outcome|JetStream Atherectomy|"Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature.~JetStream Navitus: Study to use Jetstream device for use of in-stent restenosis in femoral popliteal artery."
156524|NCT01722877|E1|Reported Event|JetStream Atherectomy|Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.
156525|NCT01722734|B4|Baseline|Total|Total of all reporting groups
156526|NCT01722734|B3|Baseline|Long Message|Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.
156527|NCT01722734|B2|Baseline|Short Message|Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
156528|NCT01722734|B1|Baseline|Control|Patients in this group received only a generic malaria information message (use bed nets) at the end of the study.
156529|NCT01722734|P3|Participant Flow|Long Message|Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.
156530|NCT01722734|P2|Participant Flow|Short Message|Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
156531|NCT01722734|P1|Participant Flow|Control|Control group participants received only a message after five days informing them about the importance of using bed nets for malaria. No reminders to take ACTs were sent.
156532|NCT01722734|O3|Outcome|Long Message|Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.
156533|NCT01722734|O2|Outcome|Short Message|Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
156534|NCT01722734|O1|Outcome|Control|Subjects in this group received only one generic malaria message (use bed nets) at the end of the study.
156535|NCT01722734|E3|Reported Event|Long Message|Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.
156536|NCT01722734|E2|Reported Event|Short Message|Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
156537|NCT01722734|E1|Reported Event|Control|Patients in this group received only a generic malaria message at the end of the study.
156538|NCT01722552|B1|Baseline|Adherence Feedback|"Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.~adherence feedback"
156539|NCT01722552|P1|Participant Flow|Adherence Feedback|"Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.~adherence feedback"
156540|NCT01722552|O2|Outcome|Control|Control subjects will use the electronic monitoring devices just like the intervention arm, but will receive standard of care. They will not receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time, and they will not have access to the summaries of their previous month's behavior for use in interactive counseling sessions, though they will be encouraged to engage in counseling.
156541|NCT01722552|O1|Outcome|Adherence Feedback|"Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.~adherence feedback"
156542|NCT01722552|O2|Outcome|Control|Control subjects will use the electronic monitoring devices just like the intervention arm, but will receive standard of care. They will not receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time, and they will not have access to the summaries of their previous month's behavior for use in interactive counseling sessions, though they will be encouraged to engage in counseling.
156543|NCT01722552|O1|Outcome|Adherence Feedback|"Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.~adherence feedback"
156544|NCT01722552|E2|Reported Event|Control|Control subjects will use the electronic monitoring devices just like the intervention arm, but will receive standard of care. They will not receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time, and they will not have access to the summaries of their previous month's behavior for use in interactive counseling sessions, though they will be encouraged to engage in counseling.
156656|NCT01721837|B1|Baseline|All Patients|All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (PPS).
157630|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
156545|NCT01722552|E1|Reported Event|Adherence Feedback|"Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.~adherence feedback"
156546|NCT01722487|B3|Baseline|Total|Total of all reporting groups
156547|NCT01722487|B2|Baseline|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
156548|NCT01722487|B1|Baseline|Ibrutinib|Ibrutinib 420 mg daily.
156549|NCT01722487|P2|Participant Flow|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
156550|NCT01722487|P1|Participant Flow|Ibrutinib|Ibrutinib 420 mg daily.
156551|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
156552|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
156553|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
156554|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
156555|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
156556|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
156557|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
156558|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
156559|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
156560|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
156561|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
156562|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
156563|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles.
156564|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
156565|NCT01722487|E2|Reported Event|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
156566|NCT01722487|E1|Reported Event|PCI-32765|Ibrutinib 420 mg daily.
156567|NCT01722435|B1|Baseline|OST Completers|"The main objective of this prospective study was the description of the process of termination of opiate substitution treatment (OST). Patients in primary care setting (GPs) or specialized clinics likely to complete OST during the next 12 months were asked to fill out questionnaires every 3 months over a 12-months period and were followed up another 6 months later. Accordingly, the doctors documented their patients’ state of health and provided an evaluation of their living situation every 3 months and at the end of treatment (or – if patients stayed in treatment – at the end of the 18-months study period).~At the beginning of the study overall 1367 OST patients were treated in the 7 participating clinics and practices. 972 of them were treated with methadone or levomethadone. In line with the inclusion criteria, 97 patients were eligible for the study, 78 of them consented to participate in the study (8.0% of all patients treated with methadone or levomethadone)."
156568|NCT01722435|P1|Participant Flow|OST Completers|"Patients who are likely to complete OST during the next 12 or 18 months~Opiate Substitution Treatment"
156569|NCT01722435|O1|Outcome|Still in OST Completers|Patients still in OST during the whole study period.
156570|NCT01722435|O1|Outcome|OST Drop-outs|Patients dropped out of OST during 12 or 18 months.
156571|NCT01722435|O1|Outcome|OST Completers|Patients completed OST during 12 or 18 months.
156572|NCT01722435|O1|Outcome|OST Completers|Patients who are likely to complete OST during the next 12 or 18 months.
156573|NCT01722435|O1|Outcome|OST Completers|Patients who are likely to complete OST during the next 12 or 18 months Opiate Substitution Treatment
156574|NCT01722435|E1|Reported Event|OST Completers|Patients who are likely to complete OST during the next 12 or 18 months Opiate Substitution Treatment
156575|NCT01722266|B5|Baseline|Total|Total of all reporting groups
156576|NCT01722266|B4|Baseline|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
156577|NCT01722266|B3|Baseline|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
156578|NCT01722266|B2|Baseline|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
156579|NCT01722266|B1|Baseline|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
156580|NCT01722266|P4|Participant Flow|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
157631|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
156581|NCT01722266|P3|Participant Flow|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
156582|NCT01722266|P2|Participant Flow|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
156583|NCT01722266|P1|Participant Flow|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
156584|NCT01722266|O4|Outcome|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
156585|NCT01722266|O3|Outcome|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
156586|NCT01722266|O2|Outcome|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
156587|NCT01722266|O1|Outcome|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
156588|NCT01722266|O4|Outcome|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
156589|NCT01722266|O3|Outcome|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
156590|NCT01722266|O2|Outcome|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
156591|NCT01722266|O1|Outcome|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
156592|NCT01722266|O4|Outcome|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
156593|NCT01722266|O3|Outcome|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
156594|NCT01722266|O2|Outcome|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
156595|NCT01722266|O1|Outcome|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
156596|NCT01722266|O4|Outcome|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
156657|NCT01721837|P1|Participant Flow|All Patients|All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (Per Protocol Set, PPS).
156597|NCT01722266|O3|Outcome|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
156598|NCT01722266|O2|Outcome|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
156599|NCT01722266|O1|Outcome|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
156600|NCT01722266|O4|Outcome|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
156601|NCT01722266|O3|Outcome|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
156602|NCT01722266|O2|Outcome|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
156603|NCT01722266|O1|Outcome|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
156604|NCT01722266|E4|Reported Event|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
156605|NCT01722266|E3|Reported Event|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
156606|NCT01722266|E2|Reported Event|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
156607|NCT01722266|E1|Reported Event|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
156608|NCT01722162|B3|Baseline|Total|Total of all reporting groups
156609|NCT01722162|B2|Baseline|Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2."
156610|NCT01722162|B1|Baseline|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
156611|NCT01722162|P2|Participant Flow|Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2."
156612|NCT01722162|P1|Participant Flow|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
156613|NCT01722162|O1|Outcome|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
156614|NCT01722162|O2|Outcome|Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2."
156658|NCT01721837|O1|Outcome|All Patients|All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (PPS).
156615|NCT01722162|O1|Outcome|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
156616|NCT01722162|O1|Outcome|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
156617|NCT01722162|E2|Reported Event|Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2."
156618|NCT01722162|E1|Reported Event|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
156619|NCT01722097|B3|Baseline|Total|Total of all reporting groups
156620|NCT01722097|B2|Baseline|Moderate Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron~placebo"
156621|NCT01722097|B1|Baseline|Deep Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron~Rocuronium"
156622|NCT01722097|P2|Participant Flow|Moderate Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron~placebo"
156623|NCT01722097|P1|Participant Flow|Deep Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron~Rocuronium"
156624|NCT01722097|O2|Outcome|Moderate Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron~placebo"
156625|NCT01722097|O1|Outcome|Deep Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron~Rocuronium"
156626|NCT01722097|O2|Outcome|Moderate Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron~placebo"
156627|NCT01722097|O1|Outcome|Deep Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron~Rocuronium"
156628|NCT01722097|E2|Reported Event|Moderate Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron~placebo"
156629|NCT01722097|E1|Reported Event|Deep Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron~Rocuronium"
156630|NCT01722071|B1|Baseline|Participants|Each participant will complete baseline assessments prior to being studied using fMRI
156631|NCT01722071|P2|Participant Flow|Oxytocin Then Placebo|"These participants were first studied using fMRI following self-administration of oxytocin (followed by another scanning session with placebo).~Oxytocin: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session."
156632|NCT01722071|P1|Participant Flow|Placebo Then Oxytocin|"These participants were first studied using fMRI following self-administration of placebo (followed by another scanning session with oxytocin).~Placebo: Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session."
156633|NCT01722071|O2|Outcome|Oxytocin Then Placebo|"Each participant will be studied using fMRI following self-administration of oxytocin.~Oxytocin: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session."
156634|NCT01722071|O1|Outcome|Placebo Then Oxytocin|"Each participant will be studied using fMRI following self-administration of placebo.~Placebo: Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session."
156635|NCT01722071|E2|Reported Event|Oxytocin Then Placebo|"Each participant will be studied using fMRI following self-administration of oxytocin.~Oxytocin: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session."
156636|NCT01722071|E1|Reported Event|Placebo Then Oxytocin|"Each participant will be studied using fMRI following self-administration of placebo.~Placebo: Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session."
156637|NCT01722045|B1|Baseline|Open Label IAI|Intravitreal Aflibercept Injection (IAI)
156638|NCT01722045|P1|Participant Flow|Open Label IAI|2 mg IAI (Intravitreal Aflibercept Injection) at 4-week intervals (2Q4) up to week 8 for a total of 3 injections, and 2 mg at 8-week intervals (2Q8) thereafter until week 96
156639|NCT01722045|O1|Outcome|Open Label IAI|2 mg IAI (Intravitreal Aflibercept Injection) at 4-week intervals (2Q4) up to week 8 for a total of 3 injections, and 2 mg at 8-week intervals (2Q8) thereafter until week 96
156640|NCT01722045|O1|Outcome|Open Label IAI|2 mg IAI (Intravitreal Aflibercept Injection) at 4-week intervals (2Q4) up to week 8 for a total of 3 injections, and 2 mg at 8-week intervals (2Q8) thereafter until week 96
156641|NCT01722045|O1|Outcome|Open Label IAI|2 mg IAI (Intravitreal Aflibercept Injection) at 4-week intervals (2Q4) up to week 8 for a total of 3 injections, and 2 mg at 8-week intervals (2Q8) thereafter until week 96
156642|NCT01722045|O1|Outcome|Open Label IAI|2 mg IAI (Intravitreal Aflibercept Injection) at 4-week intervals (2Q4) up to week 8 for a total of 3 injections, and 2 mg at 8-week intervals (2Q8) thereafter until week 96
156643|NCT01722045|O1|Outcome|Open Label IAI|2 mg IAI (Intravitreal Aflibercept Injection) at 4-week intervals (2Q4) up to week 8 for a total of 3 injections, and 2 mg at 8-week intervals (2Q8) thereafter until week 96
156644|NCT01722045|O1|Outcome|Open Label IAI|2 mg IAI (Intravitreal Aflibercept Injection) at 4-week intervals (2Q4) up to week 8 for a total of 3 injections, and 2 mg at 8-week intervals (2Q8) thereafter until week 96
156659|NCT01721837|E1|Reported Event|All Patients|All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (PPS).
156661|NCT01721772|B2|Baseline|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
156662|NCT01721772|B1|Baseline|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
156663|NCT01721772|P2|Participant Flow|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
156664|NCT01721772|P1|Participant Flow|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
156665|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
156666|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
156667|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
156668|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
156669|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
156670|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
156671|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
156672|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
156673|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
156674|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
156675|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
156676|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
156677|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
156678|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
156679|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
156680|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
156681|NCT01721772|E2|Reported Event|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
156682|NCT01721772|E1|Reported Event|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
156683|NCT01721759|B1|Baseline|Nivolumab, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
156684|NCT01721759|P1|Participant Flow|Nivolumab, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
156685|NCT01721759|O1|Outcome|Nivolumab, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
156686|NCT01721759|O1|Outcome|Nivolumab, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
156687|NCT01721759|O1|Outcome|Nivolumab, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
156688|NCT01721759|E1|Reported Event|NivolumAB, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
156689|NCT01721746|B3|Baseline|Total|Total of all reporting groups
156690|NCT01721746|B2|Baseline|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|"Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
156691|NCT01721746|B1|Baseline|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
156692|NCT01721746|P3|Participant Flow|Investigator's Choice (Carboplatin+Paclitaxel)|"Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
156693|NCT01721746|P2|Participant Flow|Investigator's Choice (Dacarbazine)|Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
156694|NCT01721746|P1|Participant Flow|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
156695|NCT01721746|O2|Outcome|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|"Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
156696|NCT01721746|O1|Outcome|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
156697|NCT01721746|O2|Outcome|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|"Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
156698|NCT01721746|O1|Outcome|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
156699|NCT01721746|O2|Outcome|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|"Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
156700|NCT01721746|O1|Outcome|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
156738|NCT01721486|O2|Outcome|Control Group|PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
156739|NCT01721486|O1|Outcome|Study Group|IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion after IV placement in OR in study group only.
173036|NCT01665170|O1|Outcome|Placebo|Placebo arm
156701|NCT01721746|O2|Outcome|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|"Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
156702|NCT01721746|O1|Outcome|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
156703|NCT01721746|O2|Outcome|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|"Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
156704|NCT01721746|O1|Outcome|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
156705|NCT01721746|O2|Outcome|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|"Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
156706|NCT01721746|O1|Outcome|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
156707|NCT01721746|E2|Reported Event|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|"Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
156708|NCT01721746|E1|Reported Event|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
156709|NCT01721681|B1|Baseline|Human Coagulation FACTOR X|"At the Baseline Visit, eligible children received a bolus dose of 50 IU/kg FACTOR X. After the Baseline Visit, children were treated with FACTOR X prophylactically for a period of 6 months (26 weeks).~A dosing regimen of 40-50 IU/kg twice a week was recommended, but was not mandatory. Each dose of FACTOR X was not to not exceed 60 IU/kg."
156710|NCT01721681|P1|Participant Flow|Overall Study|"At the Baseline Visit, eligible children received a bolus dose of 50 IU/kg FACTOR X. After the Baseline Visit, children were treated with FACTOR X prophylactically for a period of 6 months (26 weeks).~A dosing regimen of 40-50 IU/kg twice a week was recommended, but was not mandatory. Each dose of FACTOR X was not to not exceed 60 IU/kg."
156711|NCT01721681|O1|Outcome|Overall Study|"At the Baseline Visit, eligible children received a bolus dose of 50 IU/kg FACTOR X. After the Baseline Visit, children were treated with FACTOR X prophylactically for a period of 6 months (26 weeks).~A dosing regimen of 40-50 IU/kg twice a week was recommended, but was not mandatory. Each dose of FACTOR X was not to not exceed 60 IU/kg."
156712|NCT01721681|O1|Outcome|Overall Study|"At the Baseline Visit, eligible children received a bolus dose of 50 IU/kg FACTOR X. After the Baseline Visit, children were treated with FACTOR X prophylactically for a period of 6 months (26 weeks).~A dosing regimen of 40-50 IU/kg twice a week was recommended, but was not mandatory. Each dose of FACTOR X was not to not exceed 60 IU/kg."
156713|NCT01721681|O1|Outcome|Overall Study|"At the Baseline Visit, eligible children received a bolus dose of 50 IU/kg FACTOR X. After the Baseline Visit, children were treated with FACTOR X prophylactically for a period of 6 months (26 weeks).~A dosing regimen of 40-50 IU/kg twice a week was recommended, but was not mandatory. Each dose of FACTOR X was not to not exceed 60 IU/kg."
156714|NCT01721681|E1|Reported Event|Human Coagulation FACTOR X|"At the Baseline Visit, eligible children received a bolus dose of 50 IU/kg FACTOR X. After the Baseline Visit, children were treated with FACTOR X prophylactically for a period of 6 months (26 weeks).~A dosing regimen of 40-50 IU/kg twice a week was recommended, but was not mandatory. Each dose of FACTOR X was not to not exceed 60 IU/kg."
156715|NCT01721603|B1|Baseline|Dabrafenib Given in Combination With Gamma Knife Radiosurgery|"All patients will receive continuous, oral dosing of dabrafenib at a starting dose of 150 mg twice daily until progression of disease, withdrawal of consent, or the development of intolerable treatment associated toxicity~Dabrafenib: 150mg capsule by mouth twice daily~Gamma Knife Radiosurgery: This will be delivered using Gamma Knife technology. Patients will be fitted with a stereotactic head-frame for stereotactic localization of brain metastases."
156716|NCT01721603|P1|Participant Flow|Dabrafenib + Trametinib + Gamma Knife Radiosurgery|"1 cycle = 28 days~Dabrafenib: 150mg capsule by mouth (PO), twice daily, continuous~Trametinib: 2 mg PO, once daily from beginning of cycle 3 Day 1,until progression of disease, withdrawal of consent, or the development of intolerable treatment associated toxicity.~For patients with stable disease or partial tumor responses in the brain, Gamma Knife radiosurgery will be performed on treatment cycle 2, day 1 (+/- 3 days) using a stereotactic head frame and MRI imaging in accordance with FDA-approved procedures."
156740|NCT01721486|O2|Outcome|Control Group|PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
156741|NCT01721486|O1|Outcome|Study Group|IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion after IV placement in OR in study group only.
156717|NCT01721603|O1|Outcome|Dabrafenib + Trametinib + Gamma Knife Radiosurgery|"1 cycle = 28 days~Dabrafenib: 150mg capsule by mouth (PO), twice daily, continuous~Trametinib: 2 mg PO, once daily from beginning of cycle 3 Day 1,until progression of disease, withdrawal of consent, or the development of intolerable treatment associated toxicity.~For patients with stable disease or partial tumor responses in the brain, Gamma Knife radiosurgery will be performed on treatment cycle 2, day 1 (+/- 3 days) using a stereotactic head frame and MRI imaging in accordance with FDA-approved procedures."
156718|NCT01721603|O1|Outcome|Dabrafenib + Trametinib + Gamma Knife Radiosurgery|"1 cycle = 28 days~Dabrafenib: 150mg capsule by mouth (PO), twice daily, continuous~Trametinib: 2 mg PO, once daily from beginning of cycle 3 Day 1,until progression of disease, withdrawal of consent, or the development of intolerable treatment associated toxicity.~For patients with stable disease or partial tumor responses in the brain, Gamma Knife radiosurgery will be performed on treatment cycle 2, day 1 (+/- 3 days) using a stereotactic head frame and MRI imaging in accordance with FDA-approved procedures."
156719|NCT01721603|O1|Outcome|Dabrafenib + Trametinib + Gamma Knife Radiosurgery|"1 cycle = 28 days~Dabrafenib: 150mg capsule by mouth (PO), twice daily, continuous~Trametinib: 2 mg PO, once daily from beginning of cycle 3 Day 1,until progression of disease, withdrawal of consent, or the development of intolerable treatment associated toxicity.~For patients with stable disease or partial tumor responses in the brain, Gamma Knife radiosurgery will be performed on treatment cycle 2, day 1 (+/- 3 days) using a stereotactic head frame and MRI imaging in accordance with FDA-approved procedures."
156720|NCT01721603|O1|Outcome|Dabrafenib + Trametinib + Gamma Knife Radiosurgery|"1 cycle = 28 days~Dabrafenib: 150mg capsule by mouth (PO), twice daily, continuous~Trametinib: 2 mg PO, once daily from beginning of cycle 3 Day 1,until progression of disease, withdrawal of consent, or the development of intolerable treatment associated toxicity.~For patients with stable disease or partial tumor responses in the brain, Gamma Knife radiosurgery will be performed on treatment cycle 2, day 1 (+/- 3 days) using a stereotactic head frame and MRI imaging in accordance with FDA-approved procedures."
156721|NCT01721603|O1|Outcome|Dabrafenib + Trametinib + Gamma Knife Radiosurgery|"1 cycle = 28 days~Dabrafenib: 150mg capsule by mouth (PO), twice daily, continuous~Trametinib: 2 mg PO, once daily from beginning of cycle 3 Day 1,until progression of disease, withdrawal of consent, or the development of intolerable treatment associated toxicity.~For patients with stable disease or partial tumor responses in the brain, Gamma Knife radiosurgery will be performed on treatment cycle 2, day 1 (+/- 3 days) using a stereotactic head frame and MRI imaging in accordance with FDA-approved procedures."
156722|NCT01721603|O1|Outcome|Dabrafenib + Trametinib + Gamma Knife Radiosurgery|"1 cycle = 28 days~Dabrafenib: 150mg capsule by mouth (PO), twice daily, continuous~Trametinib: 2 mg PO, once daily from beginning of cycle 3 Day 1,until progression of disease, withdrawal of consent, or the development of intolerable treatment associated toxicity.~For patients with stable disease or partial tumor responses in the brain, Gamma Knife radiosurgery will be performed on treatment cycle 2, day 1 (+/- 3 days) using a stereotactic head frame and MRI imaging in accordance with FDA-approved procedures."
156723|NCT01721603|O1|Outcome|Dabrafenib + Trametinib + Gamma Knife Radiosurgery|"1 cycle = 28 days~Dabrafenib: 150mg capsule by mouth (PO), twice daily, continuous~Trametinib: 2 mg PO, once daily from beginning of cycle 3 Day 1,until progression of disease, withdrawal of consent, or the development of intolerable treatment associated toxicity.~For patients with stable disease or partial tumor responses in the brain, Gamma Knife radiosurgery will be performed on treatment cycle 2, day 1 (+/- 3 days) using a stereotactic head frame and MRI imaging in accordance with FDA-approved procedures."
156724|NCT01721603|O1|Outcome|Dabrafenib + Trametinib + Gamma Knife Radiosurgery|"1 cycle = 28 days~Dabrafenib: 150mg capsule by mouth (PO), twice daily, continuous~Trametinib: 2 mg PO, once daily from beginning of cycle 3 Day 1,until progression of disease, withdrawal of consent, or the development of intolerable treatment associated toxicity.~For patients with stable disease or partial tumor responses in the brain, Gamma Knife radiosurgery will be performed on treatment cycle 2, day 1 (+/- 3 days) using a stereotactic head frame and MRI imaging in accordance with FDA-approved procedures."
156725|NCT01721603|E1|Reported Event|Dabrafenib With Gamma Knife Radiosurgery|"Dabrafenib: 150mg capsule by mouth twice daily until progression of disease, withdrawal of consent, or the development of intolerable treatment associated toxicity~Gamma Knife Radiosurgery: This will be delivered using Gamma Knife technology. Patients will be fitted with a stereotactic head-frame for stereotactic localization of brain metastases."
156726|NCT01721564|B1|Baseline|Bosentan|62.5 mg Bosentan b.i.d. for 1 month 125 mg Bosentan b.i.d. for 5 months
156727|NCT01721564|P1|Participant Flow|Bosentan|62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
156728|NCT01721564|O1|Outcome|Bosentan|62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
156729|NCT01721564|O1|Outcome|Bosentan|62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
156730|NCT01721564|E1|Reported Event|Bosentan|62.5 mg Bosentan b.i.d. for 1 month 125 mg Bosentan b.i.d. for 5 months
156731|NCT01721486|B3|Baseline|Total|Total of all reporting groups
156732|NCT01721486|B2|Baseline|Control Group|"PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.~PO acetaminophen: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area."
156733|NCT01721486|B1|Baseline|Study Group|"IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.~IV acetaminophen: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR in study group only."
156734|NCT01721486|P2|Participant Flow|Control Group|"PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.~PO acetaminophen: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area."
156735|NCT01721486|P1|Participant Flow|Study Group|"IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.~IV acetaminophen: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR in study group only."
156736|NCT01721486|O2|Outcome|Control Group|PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
157632|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
156742|NCT01721486|O2|Outcome|Control Group|PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
156743|NCT01721486|O1|Outcome|Study Group|IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion after IV placement in OR in study group only.
156744|NCT01721486|E2|Reported Event|Control Group|"PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.~PO acetaminophen: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area."
156745|NCT01721486|E1|Reported Event|Study Group|"IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.~IV acetaminophen: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR in study group only."
156746|NCT01721460|B1|Baseline|Dexmedetomidine During MER|"Administration of dexmedetomidine during the Microelectrode recording part of STN electrode implantation surgery.~Dexmedetomidine: Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved."
156747|NCT01721460|P1|Participant Flow|Dexmedetomidine During MER|"Administration of dexmedetomidine during the Microelectrode recording (MER) part of subthalamic nucleus (STN) electrode implantation surgery.~Dexmedetomidine: Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved."
156748|NCT01721460|O1|Outcome|Dexmedetomidine During MER|Administration of dexmedetomidine during the Microelectrode recording (MER) part of subthalamic nucleus (STN) electrode implantation surgery.
156749|NCT01721460|O1|Outcome|Dexmedetomidine During MER|Administration of dexmedetomidine during the Microelectrode recording (MER) part of subthalamic nucleus (STN) electrode implantation surgery.
156750|NCT01721460|O1|Outcome|Dexmedetomidine During MER|"Administration of dexmedetomidine during the Microelectrode recording (MER) part of subthalamic nucleus (STN) electrode implantation surgery.~Dexmedetomidine: Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved."
156751|NCT01721460|O1|Outcome|Dexmedetomidine Modulation of MER|Change in RMS value between baseline (awake) and maximal sedation during dexmedetomidine administration.
156752|NCT01721460|E1|Reported Event|Treatment|"Administration of dexmedetomidine during the Microelectrode recording part of STN electrode implantation surgery.~Dexmedetomidine: Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved."
156753|NCT01721408|B3|Baseline|Total|Total of all reporting groups
156754|NCT01721408|B2|Baseline|Imipenem/Cilastatin|Participants were administered with imipenem/cilastatin (approximately 100-mL IV infusion) intravenously approximately every 6 hours. IV placebo (100 mL of normal saline) was required to be dosed immediately After the first dose of imipenem/cilastatin.
156755|NCT01721408|B1|Baseline|Tigecycline 50mg|Participants were administered with tigecycline every 12 hours (an initial intravenous [IV] dose of 100 mg followed by 50 mg twice a day [BID] approximately every 12 hours) and placebo (100-mL of normal saline) IV doses every 12 hours beginning 6 hours after the initial IV dose of tigecycline.
156756|NCT01721408|P2|Participant Flow|Imipenem/Cilastatin|Participants were administered with imipenem/cilastatin (approximately 100-mL IV infusion) intravenously approximately every 6 hours. IV placebo (100 mL of normal saline) was required to be dosed immediately After the first dose of imipenem/cilastatin.
156757|NCT01721408|P1|Participant Flow|Tigecycline 50mg|Participants were administered with tigecycline every 12 hours (an initial intravenous [IV] dose of 100 mg followed by 50 mg twice a day [BID] approximately every 12 hours) and placebo (100-mL of normal saline) IV doses every 12 hours beginning 6 hours after the initial IV dose of tigecycline.
156758|NCT01721408|O2|Outcome|Imipenem/Cilastatin|Participants were administered with imipenem/cilastatin (approximately 100-mL IV infusion) intravenously approximately every 6 hours. IV placebo (100 mL of normal saline) was required to be dosed immediately After the first dose of imipenem/cilastatin.
156759|NCT01721408|O1|Outcome|Tigecycline 50mg|Participants were administered with tigecycline every 12 hours (an initial intravenous [IV] dose of 100 mg followed by 50 mg twice a day [BID] approximately every 12 hours) and placebo (100-mL of normal saline) IV doses every 12 hours beginning 6 hours after the initial IV dose of tigecycline.
156760|NCT01721408|O2|Outcome|Imipenem/Cilastatin|Participants were administered with imipenem/cilastatin (approximately 100-mL IV infusion) intravenously approximately every 6 hours. IV placebo (100 mL of normal saline) was required to be dosed immediately After the first dose of imipenem/cilastatin.
156761|NCT01721408|O1|Outcome|Tigecycline 50mg|Participants were administered with tigecycline every 12 hours (an initial intravenous [IV] dose of 100 mg followed by 50 mg twice a day [BID] approximately every 12 hours) and placebo (100-mL of normal saline) IV doses every 12 hours beginning 6 hours after the initial IV dose of tigecycline.
156762|NCT01721408|O2|Outcome|Imipenem/Cilastatin|Participants were administered with imipenem/cilastatin (approximately 100-mL IV infusion) intravenously approximately every 6 hours. IV placebo (100 mL of normal saline) was required to be dosed immediately After the first dose of imipenem/cilastatin.
156763|NCT01721408|O1|Outcome|Tigecycline 50mg|Participants were administered with tigecycline every 12 hours (an initial intravenous [IV] dose of 100 mg followed by 50 mg twice a day [BID] approximately every 12 hours) and placebo (100-mL of normal saline) IV doses every 12 hours beginning 6 hours after the initial IV dose of tigecycline.
156764|NCT01721408|O2|Outcome|Imipenem/Cilastatin|Participants were administered with imipenem/cilastatin (approximately 100-mL IV infusion) intravenously approximately every 6 hours. IV placebo (100 mL of normal saline) was required to be dosed immediately After the first dose of imipenem/cilastatin.
156765|NCT01721408|O1|Outcome|Tigecycline 50mg|Participants were administered with tigecycline every 12 hours (an initial intravenous [IV] dose of 100 mg followed by 50 mg twice a day [BID] approximately every 12 hours) and placebo (100-mL of normal saline) IV doses every 12 hours beginning 6 hours after the initial IV dose of tigecycline.
156799|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156766|NCT01721408|O2|Outcome|Imipenem/Cilastatin|Participants were administered with imipenem/cilastatin (approximately 100-mL IV infusion) intravenously approximately every 6 hours. IV placebo (100 mL of normal saline) was required to be dosed immediately After the first dose of imipenem/cilastatin.
156767|NCT01721408|O1|Outcome|Tigecycline 50mg|Participants were administered with tigecycline every 12 hours (an initial intravenous [IV] dose of 100 mg followed by 50 mg twice a day [BID] approximately every 12 hours) and placebo (100-mL of normal saline) IV doses every 12 hours beginning 6 hours after the initial IV dose of tigecycline.
156768|NCT01721408|E2|Reported Event|Imipenem/Cilastatin|Participants were administered with imipenem/cilastatin (approximately 100-mL IV infusion) intravenously approximately every 6 hours. IV placebo (100 mL of normal saline) was required to be dosed immediately After the first dose of imipenem/cilastatin.
156769|NCT01721408|E1|Reported Event|Tigecycline 50mg|Participants were administered with tigecycline every 12 hours (an initial intravenous [IV] dose of 100 mg followed by 50 mg twice a day [BID] approximately every 12 hours) and placebo (100-mL of normal saline) IV doses every 12 hours beginning 6 hours after the initial IV dose of tigecycline.
156770|NCT01721330|B3|Baseline|Total|Total of all reporting groups
156771|NCT01721330|B2|Baseline|Placebo|"Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.~Placebo: Placebo twice a day for 6 weeks"
156772|NCT01721330|B1|Baseline|Naltrexone|"Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.~Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks"
156773|NCT01721330|P2|Participant Flow|Placebo|"Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.~Placebo: Placebo twice a day for 6 weeks"
156774|NCT01721330|P1|Participant Flow|Naltrexone|"Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.~Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks"
156775|NCT01721330|O2|Outcome|Placebo|"Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.~Placebo: Placebo twice a day for 6 weeks"
156776|NCT01721330|O1|Outcome|Naltrexone|"Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.~Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks"
156777|NCT01721330|E2|Reported Event|Placebo|"Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.~Placebo: Placebo twice a day for 6 weeks"
156778|NCT01721330|E1|Reported Event|Naltrexone|"Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.~Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks"
156779|NCT01721317|B3|Baseline|Total|Total of all reporting groups
156780|NCT01721317|B2|Baseline|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156781|NCT01721317|B1|Baseline|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156782|NCT01721317|P2|Participant Flow|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 milligrams (mg)/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156783|NCT01721317|P1|Participant Flow|Placebo|Participants received matching ezogabine/retigabine IR placebo orally three times a day (TID) in equally or unequally divided doses.
156784|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156785|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156786|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156787|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156788|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156789|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156790|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156791|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156792|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156793|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156794|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156795|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156796|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156797|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156798|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156800|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156801|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156802|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156803|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156804|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156805|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156806|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156807|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156808|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156809|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156810|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156811|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156812|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156813|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156814|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156815|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156816|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156817|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156818|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156819|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156820|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156821|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156822|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156823|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156824|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156825|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156826|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156827|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156828|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156829|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156830|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156831|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156832|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156834|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156835|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156836|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156837|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156838|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156839|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156840|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156841|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156842|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156843|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156844|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156845|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156846|NCT01721317|E2|Reported Event|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
156847|NCT01721317|E1|Reported Event|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
156848|NCT01721226|B3|Baseline|Total|Total of all reporting groups
156849|NCT01721226|B2|Baseline|CARE Tool and Cell Phone/Text Messaging|The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
156850|NCT01721226|B1|Baseline|Control Arm|Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
156851|NCT01721226|P2|Participant Flow|CARE Tool and Cell Phone/Text Messaging|The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
156852|NCT01721226|P1|Participant Flow|Control Arm|Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
156853|NCT01721226|O2|Outcome|CARE Tool and Cell Phone/Text Messaging|The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
156854|NCT01721226|O1|Outcome|Control Arm|Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
156855|NCT01721226|O2|Outcome|CARE Tool and Cell Phone/Text Messaging|The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
156856|NCT01721226|O1|Outcome|Control Arm|Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
156911|NCT01721109|B1|Baseline|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
157112|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
156857|NCT01721226|E2|Reported Event|CARE Tool and Cell Phone/Text Messaging|The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
156858|NCT01721226|E1|Reported Event|Control Arm|Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
156859|NCT01721200|B3|Baseline|Total|Total of all reporting groups
156860|NCT01721200|B2|Baseline|Usual Care|"Usual Care Group will receive their biologic drug teaching from their rheumatologist.~Usual Care: Subjects randomized to the Usual Care Group will receive their biologic drug teaching from the rheumatologist as part of their routine care."
156861|NCT01721200|B1|Baseline|Decision Support Tool|"This study will examine the efficacy of a web-based educational decision support tool.~Decision Support Tool: Educational decision support tool for patients with rheumatoid arthritis"
156862|NCT01721200|P2|Participant Flow|Usual Care|"Usual Care Group will receive their biologic drug teaching from their rheumatologist.~Usual Care: Subjects randomized to the Usual Care Group will receive their biologic drug teaching from the rheumatologist as part of their routine care."
156863|NCT01721200|P1|Participant Flow|Decision Support Tool|"This study will examine the efficacy of a web-based educational decision support tool.~Decision Support Tool: Educational decision support tool for patients with rheumatoid arthritis"
156864|NCT01721200|O2|Outcome|Control|
156865|NCT01721200|O1|Outcome|Intervention Group|
156866|NCT01721200|O2|Outcome|Control|Usual Care
156867|NCT01721200|O1|Outcome|Intervention Group|Randomized to view the decision support tool.
156868|NCT01721200|O2|Outcome|Control|
156869|NCT01721200|O1|Outcome|1 Intervention|
156870|NCT01721200|O2|Outcome|Decision Support Tool|"This study will examine the efficacy of a web-based educational decision support tool.~Decision Support Tool: Educational decision support tool for patients with rheumatoid arthritis"
156871|NCT01721200|O1|Outcome|Usual Care|"Usual Care Group will receive their biologic drug teaching from their rheumatologist.~Usual Care: Subjects randomized to the Usual Care Group will receive their biologic drug teaching from the rheumatologist as part of their routine care."
156872|NCT01721200|O1|Outcome|Intervention Group|
156873|NCT01721200|O2|Outcome|Control|Usual Care
156874|NCT01721200|O1|Outcome|Intervention Group|Randomized to view the decision support tool.
156875|NCT01721200|O2|Outcome|Control|Usual Care
156876|NCT01721200|O1|Outcome|Intervention Group|Randomized to view the decision support tool.
156877|NCT01721200|O2|Outcome|Control|
156878|NCT01721200|O1|Outcome|1 Intervention|
156879|NCT01721200|O2|Outcome|Control|
156880|NCT01721200|O1|Outcome|1 Intervention|
156881|NCT01721200|O2|Outcome|Control|Usual Care
156882|NCT01721200|O1|Outcome|Intervention Group|Randomized to view the decision support tool.
156883|NCT01721200|E2|Reported Event|Decision Support Tool|"This study will examine the efficacy of a web-based educational decision support tool.~Decision Support Tool: Educational decision support tool for patients with rheumatoid arthritis"
156884|NCT01721200|E1|Reported Event|Usual Care|"Usual Care Group will receive their biologic drug teaching from their rheumatologist.~Usual Care: Subjects randomized to the Usual Care Group will receive their biologic drug teaching from the rheumatologist as part of their routine care."
156885|NCT01721161|B3|Baseline|Total|Total of all reporting groups
156886|NCT01721161|B2|Baseline|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
156887|NCT01721161|B1|Baseline|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
156888|NCT01721161|P2|Participant Flow|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
156889|NCT01721161|P1|Participant Flow|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
156890|NCT01721161|O1|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
156891|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
156892|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
156893|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
156894|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
156895|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
156896|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
156897|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
156898|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
156899|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
156900|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
156901|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
156902|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
156903|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
156904|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
156905|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
173037|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
156912|NCT01721109|P1|Participant Flow|EVG/COBI/FTC/TDF|Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; EVG/COBI/FTC/TDF) (150/150/200/300 mg) single-tablet regiment (STR) administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase.
156913|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
156914|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
156915|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
156916|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
156917|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
156918|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
156919|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
156920|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
156921|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
156922|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
156923|NCT01721109|E1|Reported Event|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
156924|NCT01721096|B3|Baseline|Total|Total of all reporting groups
156925|NCT01721096|B2|Baseline|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156926|NCT01721096|B1|Baseline|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156927|NCT01721096|P2|Participant Flow|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156928|NCT01721096|P1|Participant Flow|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156929|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156930|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156931|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156932|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156933|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157109|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through week 24.~Participants will continue to take background cDMARD therapy throughout study."
173038|NCT01665170|O1|Outcome|Placebo|Placebo arm
156934|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156935|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156936|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156937|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156938|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156939|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156940|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156941|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156942|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156943|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156944|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156945|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156946|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156947|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156948|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156949|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157633|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
156950|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156951|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156952|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156953|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156954|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156955|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156956|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156957|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156958|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156959|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156960|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156961|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156962|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156963|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156964|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156965|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157634|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
156966|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156967|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156968|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156969|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156970|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156971|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156972|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156973|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156974|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156975|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156976|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156977|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156978|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156979|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156980|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156981|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157635|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
156982|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156983|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156984|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156985|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156986|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156987|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156988|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156989|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156990|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156991|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156992|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156993|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156994|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156995|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156996|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156997|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157636|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
156998|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
156999|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157000|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157001|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157002|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157003|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157004|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157005|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157006|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157007|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157008|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157009|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157010|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157011|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157012|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157013|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157637|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
157014|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157015|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157016|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157017|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157018|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157019|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157020|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157021|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157022|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157023|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157024|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157025|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157026|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157027|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157028|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157029|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157638|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
157030|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157031|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157032|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157033|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157034|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157035|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157036|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157037|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157038|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157039|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157040|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157041|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157042|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157043|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157044|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157045|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157639|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
157046|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157047|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157048|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157049|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157050|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157051|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157052|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157053|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157054|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157055|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157056|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157057|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157058|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157059|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157060|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157061|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157640|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
157062|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157063|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157064|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157065|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157066|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157067|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157068|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157069|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157070|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157071|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157072|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157073|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157074|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157075|NCT01721096|E1|Reported Event|XIENCE PRIME - Long Length (LL) and Core Size (CS)|The study has 2 arms depending upon the size of stent used for the treatment: Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length), whereas Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
157076|NCT01721070|B1|Baseline|SUF NT 15 mcg Then 3 Days of Ketoconazole and SUF NT 15 mcg|"Period 1: SUF NT 15 mcg administered once sublingually. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil.~Period 2: Ketoconazole 400 mg given daily for three days. One SUF NT 15 mcg was also co-administered sublingually with the third (last) ketoconazole dose.~Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil."
157110|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally (PO) once daily (QD) through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
157077|NCT01721070|P1|Participant Flow|SUF NT 15 mcg Followed by Ketoconazole 400 mg + SUF NT 15 mcg|"Period 1: One SUF NT 15 mcg administered sublingually followed by Period 2.~Period 2: Ketoconazole 400 mg given daily for three days; One SUF NT 15 mcg was also co-administered sublingually with the third (last) ketoconazole dose.~Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT 15 mcg dosing to block the opioid effects of the sufentanil."
157078|NCT01721070|O2|Outcome|Ketoconazole 400 mg and SUF NT 15 mcg|"Ketoconazole 400 mg given daily for three days. One SUF NT15 mcg is also co-administered sublingually with the third (last) ketoconazole dose.~Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil."
157079|NCT01721070|O1|Outcome|SUF NT 15 mcg|One SUF NT 15 mcg administered sublingually. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil.
157080|NCT01721070|O2|Outcome|Ketoconazole 400 mg and SUF NT 15 mcg|"Ketoconazole 400 mg given orally daily for three days. One SUF NT 15 mcg is also co-administered sublingually with the third (last) ketoconazole dose.~Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil."
157081|NCT01721070|O1|Outcome|SUF NT 15 mcg|One SUF NT 15 mcg administered sublingually. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil.
157082|NCT01721070|E2|Reported Event|Ketoconazole 400 mg + SUF NT 15 mcg|"Ketoconazole 400 mg given daily for three days. One SUF NT 15 mcg was also co-administered sublingually with the third (last) ketoconazole dose.~Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil."
157083|NCT01721070|E1|Reported Event|SUF NT 15 mcg|"One SUF NT 15 mcg administered sublingually.~Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil."
157084|NCT01721057|B4|Baseline|Total|Total of all reporting groups
157085|NCT01721057|B3|Baseline|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through week 24.~Participants continued to take background cDMARD therapy throughout study."
157086|NCT01721057|B2|Baseline|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through week 24.~Participants continued to take background cDMARD therapy throughout study."
157087|NCT01721057|B1|Baseline|Placebo|"Placebo administered orally (PO) once daily (QD) through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157088|NCT01721057|P7|Participant Flow|Baricitinib 4 mg- Follow Up|"No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.~Includes participants who were rescued to Baricitinib 4 mg."
157089|NCT01721057|P6|Participant Flow|Baricitinib 2 mg- Follow Up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
157090|NCT01721057|P5|Participant Flow|Placebo-Follow Up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
157091|NCT01721057|P4|Participant Flow|Rescue|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157092|NCT01721057|P3|Participant Flow|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157093|NCT01721057|P2|Participant Flow|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157094|NCT01721057|P1|Participant Flow|Placebo|"Placebo administered orally (PO) once daily (QD)through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
157095|NCT01721057|O2|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through week 24.~Participants will continue to take background cDMARD therapy throughout study."
157096|NCT01721057|O1|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through week 24.~Participants will continue to take background cDMARD therapy throughout study."
157097|NCT01721057|O2|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through week 24.~Participants will continue to take background cDMARD therapy throughout study."
157098|NCT01721057|O1|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through week 24.~Participants will continue to take background cDMARD therapy throughout study."
157099|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157100|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157101|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
157102|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants will continue to take background cDMARD therapy throughout study."
157103|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157104|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
157105|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157106|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157107|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
157108|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through week 24.~Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally daily through Week 24.~Participants will continue to take background cDMARD therapy throughout study."
173039|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
157113|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
157114|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157115|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157116|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
157117|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157118|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157119|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
157120|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants will continue to take background cDMARD therapy throughout study."
157121|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157122|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
157123|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157124|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157125|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
157126|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157127|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157128|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
157129|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157130|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157131|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants will continue to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
157132|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through week 24.~Participants will continue to take background cDMARD therapy throughout study."
157133|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through week 24.~Participants will continue to take background cDMARD therapy throughout study."
157134|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally (PO) once daily (QD) through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
157135|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157136|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157137|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
157138|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157139|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157140|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
157141|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157142|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157143|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
157144|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through week 24.~Participants continued to take background cDMARD therapy throughout study."
157145|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through week 24.~Participants will continued to take background cDMARD therapy throughout study."
157146|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally (PO) once daily (QD) through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
157147|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157347|NCT01720316|O2|Outcome|Subject 2:Brain Glycine/CR Ratio at Baseline/Week 6 of Glycine|Brain glycine/CR ratio at baseline and week 6 of glycine for one participant
157148|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157149|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
157150|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157151|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157152|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
157153|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157154|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157155|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally (PO) once daily (QD)through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
157156|NCT01721057|E7|Reported Event|Baricitinib 4 mg- Follow Up|"No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.~Includes participants who were rescued to Baricitinib 4 mg."
157157|NCT01721057|E6|Reported Event|Baricitinib 2 mg- Follow Up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
157158|NCT01721057|E5|Reported Event|Placebo-Follow Up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
157159|NCT01721057|E4|Reported Event|Rescue|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157160|NCT01721057|E3|Reported Event|Baricitinib 4 Mg-Treatment Period|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157161|NCT01721057|E2|Reported Event|Baricitinib 2 Mg-Treatment Period|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
157162|NCT01721057|E1|Reported Event|Placebo-Treatment Period|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
157163|NCT01721044|B4|Baseline|Total|Total of all reporting groups
157164|NCT01721044|B3|Baseline|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157165|NCT01721044|B2|Baseline|Baricitinib 2 mg|Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157166|NCT01721044|B1|Baseline|Placebo|Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157167|NCT01721044|P3|Participant Flow|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157168|NCT01721044|P2|Participant Flow|Baricitinib 2 mg|Baricitinib 2 milligram (mg) administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157169|NCT01721044|P1|Participant Flow|Placebo|Placebo administered orally (PO) once daily (QD) through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
157170|NCT01721044|O2|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered PO QD through Week 24 (n=177). Participants rescued to 4mg (N=33) are included in the PK baricitinib 4 mg arm.~Participants continued to take background cDMARD therapy throughout study."
157171|NCT01721044|O1|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered PO QD through Week 24 (N=185). Participants who were randomized to 4mg (N=11) but actually received 2 mg due to moderate renal impairment were included in the 2-mg group.~Participants continued to take background cDMARD therapy throughout study."
157172|NCT01721044|O2|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered PO QD through Week 24 (n=177). Participants rescued to 4mg (N=33) are included in the PK baricitinib 4 mg arm.~Participants continued to take background cDMARD therapy throughout study."
157173|NCT01721044|O1|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered PO QD through Week 24 (N=185). Participants who were randomized to 4mg (N=11) but actually received 2 mg due to moderate renal impairment were included in the 2-mg group.~Participants continued to take background cDMARD therapy throughout study."
157174|NCT01721044|O3|Outcome|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157175|NCT01721044|O2|Outcome|Baricitinib 2 mg|Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157176|NCT01721044|O1|Outcome|Placebo|Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157177|NCT01721044|O3|Outcome|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157178|NCT01721044|O2|Outcome|Baricitinib 2 mg|Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157179|NCT01721044|O1|Outcome|Placebo|Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157180|NCT01721044|O3|Outcome|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157181|NCT01721044|O2|Outcome|Baricitinib 2 mg|Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157182|NCT01721044|O1|Outcome|Placebo|Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157183|NCT01721044|O3|Outcome|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157184|NCT01721044|O2|Outcome|Baricitinib 2 mg|Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157185|NCT01721044|O1|Outcome|Placebo|Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157186|NCT01721044|O3|Outcome|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157187|NCT01721044|O2|Outcome|Baricitinib 2 mg|Baricitinib 2 mg administered PO QD through Week 24. Participants will continue to take background cDMARD therapy throughout study.
157188|NCT01721044|O1|Outcome|Placebo|Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157189|NCT01721044|O3|Outcome|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157190|NCT01721044|O2|Outcome|Baricitinib 2 mg|Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157191|NCT01721044|O1|Outcome|Placebo|Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157192|NCT01721044|O3|Outcome|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157193|NCT01721044|O2|Outcome|Baricitinib 2 mg|Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157194|NCT01721044|O1|Outcome|Placebo|Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157195|NCT01721044|O3|Outcome|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157196|NCT01721044|O2|Outcome|Baricitinib 2 mg|Baricitinib 2 mg administered PO QD through Week 24. Participants will continue to take background cDMARD therapy throughout study.
157197|NCT01721044|O1|Outcome|Placebo|Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157198|NCT01721044|O3|Outcome|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157199|NCT01721044|O2|Outcome|Baricitinib 2 mg|Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157200|NCT01721044|O1|Outcome|Placebo|Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157201|NCT01721044|O3|Outcome|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157202|NCT01721044|O2|Outcome|Baricitinib 2 mg|Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157203|NCT01721044|O1|Outcome|Placebo|Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157204|NCT01721044|O3|Outcome|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD through Week 24. Participants will continue to take background cDMARD therapy throughout study.
157205|NCT01721044|O2|Outcome|Baricitinib 2 mg|baricitinib 2 mg administered PO QD through Week 24. Participants will continue to take background cDMARD therapy throughout study.
157206|NCT01721044|O1|Outcome|Placebo|Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157207|NCT01721044|O3|Outcome|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD through Week 24. Participants will continue to take background cDMARD therapy throughout study.
157208|NCT01721044|O2|Outcome|Baricitinib 2 mg|Baricitinib 2 mg administered PO QD through Week 24. Participants will continue to take background cDMARD therapy throughout study.
157209|NCT01721044|O1|Outcome|Placebo|Placebo administered PO QD through Week 24. Participants will continue to take background cDMARD therapy throughout study.
157210|NCT01721044|O3|Outcome|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157211|NCT01721044|O2|Outcome|Baricitinib 2 mg|Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157212|NCT01721044|O1|Outcome|Placebo|Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157213|NCT01721044|O3|Outcome|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157214|NCT01721044|O2|Outcome|Baricitinib 2 mg|Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157215|NCT01721044|O1|Outcome|Placebo|Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157216|NCT01721044|O2|Outcome|Baricitinib 2 mg|Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157217|NCT01721044|O1|Outcome|Placebo|Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157218|NCT01721044|O2|Outcome|Baricitinib 2 mg|Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157219|NCT01721044|O1|Outcome|Placebo|Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157220|NCT01721044|O2|Outcome|Baricitinib 2 mg|Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157221|NCT01721044|O1|Outcome|Placebo|Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157222|NCT01721044|O2|Outcome|Baricitinib 2 mg|Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157223|NCT01721044|O1|Outcome|Placebo|Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157499|NCT01719003|O3|Outcome|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
157224|NCT01721044|O2|Outcome|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157225|NCT01721044|O1|Outcome|Placebo|Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157226|NCT01721044|O2|Outcome|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157227|NCT01721044|O1|Outcome|Placebo|Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157228|NCT01721044|O2|Outcome|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157229|NCT01721044|O1|Outcome|Placebo|Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157230|NCT01721044|O2|Outcome|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157231|NCT01721044|O1|Outcome|Placebo|Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157232|NCT01721044|E7|Reported Event|Baricitinib 4 mg - Follow Up Period|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
157233|NCT01721044|E6|Reported Event|Baricitinib 2 mg - Follow Up Period|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
157234|NCT01721044|E5|Reported Event|Placebo - Follow Up Period|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
157235|NCT01721044|E4|Reported Event|Rescue Period|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157236|NCT01721044|E3|Reported Event|Baricitinib 4 mg - Treatment Period|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157237|NCT01721044|E2|Reported Event|Baricitinib 2 mg - Treatment Period|Baricitinib 2mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157238|NCT01721044|E1|Reported Event|Placebo -Treatment Period|Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
157239|NCT01720797|B3|Baseline|Total|Total of all reporting groups
157240|NCT01720797|B2|Baseline|Non Micro-osteoperforation|Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.
157241|NCT01720797|B1|Baseline|Micro-osteoperforation|Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.
157242|NCT01720797|P2|Participant Flow|Non Micro-osteoperforation|Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.
157243|NCT01720797|P1|Participant Flow|Micro-osteoperforation|"Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.~Micro-osteoperforation: Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement.~Anesthestic: Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice.~Chlorhexidine: Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice. Following procedure Chlorhexidine rinses are to begin twice a day for a week."
157244|NCT01720797|O2|Outcome|Non Micro-osteoperforation|Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.
157245|NCT01720797|O1|Outcome|Micro-osteoperforation|Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.
157246|NCT01720797|E2|Reported Event|Non Micro-osteoperforation|"Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.~Chlorhexidine: Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice. Following procedure Chlorhexidine rinses are to begin twice a day for a week."
157247|NCT01720797|E1|Reported Event|Micro-osteoperforation|Minimally invasive micro-osteoperforation (PROPEL™) procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.
157248|NCT01720602|B1|Baseline|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.~vorinostat: Given PO~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~positron emission tomography: Correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~fludeoxyglucose F 18: Correlative studies~laboratory biomarker analysis: Correlative studies"
157249|NCT01720602|P1|Participant Flow|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.~vorinostat: Given PO~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~positron emission tomography: Correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~fludeoxyglucose F 18: Correlative studies~laboratory biomarker analysis: Correlative studies"
173040|NCT01665170|O1|Outcome|Placebo|Placebo arm
157250|NCT01720602|O1|Outcome|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.~vorinostat: Given PO~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~positron emission tomography: Correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~fludeoxyglucose F 18: Correlative studies~laboratory biomarker analysis: Correlative studies"
157251|NCT01720602|O1|Outcome|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.~vorinostat: Given PO~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~positron emission tomography: Correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~fludeoxyglucose F 18: Correlative studies~laboratory biomarker analysis: Correlative studies"
157252|NCT01720602|O1|Outcome|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.~vorinostat: Given PO~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~positron emission tomography: Correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~fludeoxyglucose F 18: Correlative studies~laboratory biomarker analysis: Correlative studies"
157253|NCT01720602|E1|Reported Event|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.~vorinostat: Given PO~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~positron emission tomography: Correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~fludeoxyglucose F 18: Correlative studies~laboratory biomarker analysis: Correlative studies"
157254|NCT01720446|B5|Baseline|Total|Total of all reporting groups
157255|NCT01720446|B4|Baseline|Placebo 1.0 mg|Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157256|NCT01720446|B3|Baseline|Placebo 0.5 mg|Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157257|NCT01720446|B2|Baseline|Semaglutide 1.0 mg|Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157258|NCT01720446|B1|Baseline|Semaglutide 0.5 mg|Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157259|NCT01720446|P4|Participant Flow|Placebo 1.0 mg|Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157260|NCT01720446|P3|Participant Flow|Placebo 0.5 mg|Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157261|NCT01720446|P2|Participant Flow|Semaglutide 1.0 mg|Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157262|NCT01720446|P1|Participant Flow|Semaglutide 0.5 mg|Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157263|NCT01720446|O4|Outcome|Placebo 1.0 mg|Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157264|NCT01720446|O3|Outcome|Placebo 0.5 mg|Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157265|NCT01720446|O2|Outcome|Semaglutide 1.0 mg|Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157266|NCT01720446|O1|Outcome|Semaglutide 0.5 mg|Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157267|NCT01720446|O4|Outcome|Placebo 1.0 mg|Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157268|NCT01720446|O3|Outcome|Placebo 0.5 mg|Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157269|NCT01720446|O2|Outcome|Semaglutide 1.0 mg|Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157270|NCT01720446|O1|Outcome|Semaglutide 0.5 mg|Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157271|NCT01720446|O4|Outcome|Placebo 1.0 mg|Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157272|NCT01720446|O3|Outcome|Placebo 0.5 mg|Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157273|NCT01720446|O2|Outcome|Semaglutide 1.0 mg|Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157274|NCT01720446|O1|Outcome|Semaglutide 0.5 mg|Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157275|NCT01720446|O2|Outcome|Semaglutide 1.0 mg|Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157276|NCT01720446|O1|Outcome|Semaglutide 0.5 mg|Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157348|NCT01720316|O1|Outcome|Subject1: Brain Glycine/CR Ratio at Baseline/Week 6 of Glycine|Brain glycine/CR ratio at baseline and week 6 of glycine for one participant: Subject 1
157641|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
157277|NCT01720446|O4|Outcome|Placebo 1.0 mg|Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157278|NCT01720446|O3|Outcome|Placebo 0.5 mg|Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157279|NCT01720446|O2|Outcome|Semaglutide 1.0 mg|Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157280|NCT01720446|O1|Outcome|Semaglutide 0.5 mg|Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157281|NCT01720446|O4|Outcome|Placebo 1.0 mg|Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157282|NCT01720446|O3|Outcome|Placebo 0.5 mg|Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157283|NCT01720446|O2|Outcome|Semaglutide 1.0 mg|Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157284|NCT01720446|O1|Outcome|Semaglutide 0.5 mg|Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157285|NCT01720446|O4|Outcome|Placebo 1.0 mg|Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157286|NCT01720446|O3|Outcome|Placebo 0.5 mg|Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157287|NCT01720446|O2|Outcome|Semaglutide 1.0 mg|Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157288|NCT01720446|O1|Outcome|Semaglutide 0.5 mg|Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157289|NCT01720446|O4|Outcome|Placebo 1.0 mg|Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157349|NCT01720316|O2|Outcome|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
157642|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
157290|NCT01720446|O3|Outcome|Placebo 0.5 mg|Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157291|NCT01720446|O2|Outcome|Semaglutide 1.0 mg|Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157292|NCT01720446|O1|Outcome|Semaglutide 0.5 mg|Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157293|NCT01720446|O4|Outcome|Placebo 1.0 mg|Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157294|NCT01720446|O3|Outcome|Placebo 0.5 mg|Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157295|NCT01720446|O2|Outcome|Semaglutide 1.0 mg|Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157296|NCT01720446|O1|Outcome|Semaglutide 0.5 mg|Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157297|NCT01720446|O3|Outcome|Placebo|Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157298|NCT01720446|O2|Outcome|Semaglutide 1.0 mg|Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157299|NCT01720446|O1|Outcome|Semaglutide 0.5 mg|Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157300|NCT01720446|O4|Outcome|Placebo 1.0 mg|Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157301|NCT01720446|O3|Outcome|Placebo 0.5 mg|Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157302|NCT01720446|O2|Outcome|Semaglutide 1.0 mg|Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157350|NCT01720316|O1|Outcome|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
157303|NCT01720446|O1|Outcome|Semaglutide 0.5 mg|Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157304|NCT01720446|O4|Outcome|Placebo 1.0 mg|Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157305|NCT01720446|O3|Outcome|Placebo 0.5 mg|Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157306|NCT01720446|O2|Outcome|Semaglutide 1.0 mg|Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157307|NCT01720446|O1|Outcome|Semaglutide 0.5 mg|Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157308|NCT01720446|O2|Outcome|Placebo|Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157309|NCT01720446|O1|Outcome|Semaglutide|Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157310|NCT01720446|O2|Outcome|Placebo|Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157311|NCT01720446|O1|Outcome|Semaglutide|Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157312|NCT01720446|O2|Outcome|Placebo|Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157313|NCT01720446|O1|Outcome|Semaglutide|Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157314|NCT01720446|O2|Outcome|Placebo|Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157351|NCT01720316|O2|Outcome|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
157387|NCT01720251|P2|Participant Flow|AllerT Low Dose|"SC injections of AllerT 25 or 50 micrograms~AllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56"
157315|NCT01720446|O1|Outcome|Semaglutide|Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157316|NCT01720446|E4|Reported Event|Placebo 1.0 mg|Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157317|NCT01720446|E3|Reported Event|Placebo 0.5 mg|Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157318|NCT01720446|E2|Reported Event|Semaglutide 1.0 mg|Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
157319|NCT01720446|E1|Reported Event|Semaglutide 0.5 mg|Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
157320|NCT01720316|B3|Baseline|Total|Total of all reporting groups
157321|NCT01720316|B2|Baseline|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
157322|NCT01720316|B1|Baseline|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
157323|NCT01720316|P2|Participant Flow|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then the participant received open-label glycine for 6 weeks.
157324|NCT01720316|P1|Participant Flow|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then the participant received open-label glycine for 6 weeks.
157325|NCT01720316|O4|Outcome|Auditory ERPs Amplitude (Deg) 6 Weeks of Glycine: Subject 2|Subject2: Auditory ERPs (amplitude) week 6 of glycine
157326|NCT01720316|O3|Outcome|Auditory ERPs Amplitude (Deg) Baseline: Subject 2|Subject2: Auditory ERPs (amplitude) baseline
157327|NCT01720316|O2|Outcome|Auditory ERPs Amplitude (Deg) 6 Weeks of Glycine: Subject 1|Subject1: Auditory ERPs (amplitude) week 6 of glycine
157328|NCT01720316|O1|Outcome|Auditory ERPs Amplitude (Deg) Baseline: Subject 1|Subject1: Auditory ERPs (amplitude) baseline
157329|NCT01720316|O4|Outcome|Auditory ERPs Gamma 6 Weeks of Glycine: Subject 2|Subject2: Auditory ERPs (gamma phase locking) week 6 of glycine
157330|NCT01720316|O3|Outcome|Auditory ERPs Gamma Baseline: Subject 2|Subject2: Auditory ERPs (gamma phase locking) baseline
157331|NCT01720316|O2|Outcome|Auditory ERPs Gamma 6 Weeks of Glycine: Subject 1|Subject1: Auditory ERPs (gamma phase locking) week 6 of glycine
157332|NCT01720316|O1|Outcome|Auditory ERPs Gamma Baseline: Subject 1|Subject1: Auditory ERPs (gamma phase locking) baseline
157333|NCT01720316|O4|Outcome|Auditory ERPs Amplitude (Deg) 6 Weeks of Glycine: Subject 2|Subject2: Auditory ERPs (amplitude) week 6 of glycine
157334|NCT01720316|O3|Outcome|Auditory ERPs Amplitude (Deg) Baseline: Subject 2|Subject2: Auditory ERPs (amplitude) baseline
157335|NCT01720316|O2|Outcome|Auditory ERPs Amplitude (Deg) 6 Weeks of Glycine: Subject 1|Subject1: Auditory ERPs (amplitude) week 6 of glycine
157336|NCT01720316|O1|Outcome|Auditory ERPs Amplitude (Deg) Baseline: Subject 1|Subject1: Auditory ERPs (amplitude) baseline
157337|NCT01720316|O2|Outcome|Placebo|"placebo, TID dosing, 6 weeks~placebo"
157338|NCT01720316|O1|Outcome|Glycine|"Glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks~glycine powder: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine"
157339|NCT01720316|O4|Outcome|Auditory ERPs Latency (ms) 6 Weeks of Glycine: Subject 2|Subject2: Auditory ERPs (latency) week 6 of glycine
157340|NCT01720316|O3|Outcome|Auditory ERPs Latency (ms) Baseline: Subject 2|Subject2: Auditory ERPs (latency) baseline
157341|NCT01720316|O2|Outcome|Auditory ERPs Latency (ms) 6 Weeks of Glycine: Subject 1|Subject1: Auditory ERPs (latency) week 6 of glycine
157342|NCT01720316|O1|Outcome|Auditory ERPs Latency (ms) Baseline: Subject 1|Subject1: Auditory ERPs (latency) baseline
157343|NCT01720316|O2|Outcome|Subject2: Brain GABA/CR Ratio- Baseline/Week 6 of Glycine|Brain GABA/CR ratio at baseline and week 6 of glycine for one participant: Subject 2
157344|NCT01720316|O1|Outcome|Subject1: Brain GABA/CR Ratio- Baseline/Week 6 of Glycine|Brain GABA/CR ratio at baseline and week 6 of glycine for one participant: Subject 1
157345|NCT01720316|O2|Outcome|Subject2: Brain Glutamate/CR Ratio- Baseline/Week 6 of Glycine|Brain glutamate/CR ratio at baseline and week 6 of glycine for one participant: Subject 2
157346|NCT01720316|O1|Outcome|Subject1: Brain Glutamate/CR Ratio- Baseline/Week 6 of Glycine|Brain glutamate/CR ratio at baseline and week 6 of glycine for one participant: Subject 1
157352|NCT01720316|O1|Outcome|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
157353|NCT01720316|O2|Outcome|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
157354|NCT01720316|O1|Outcome|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
157355|NCT01720316|O2|Outcome|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
157356|NCT01720316|O1|Outcome|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
157357|NCT01720316|O2|Outcome|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
157358|NCT01720316|O1|Outcome|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
157359|NCT01720316|O2|Outcome|Placebo Then Glycine|"placebo, TID dosing, 6 weeks Double-blind~placebo"
157360|NCT01720316|O1|Outcome|Glycine Then Placebo|"Glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks Double-blind~Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine"
157361|NCT01720316|O4|Outcome|Composite Score on Glycine, Open-label|"glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks~Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine"
157362|NCT01720316|O3|Outcome|Composite Score on Placebo|"placebo, TID dosing, 6 weeks Double-blind~placebo"
157363|NCT01720316|O2|Outcome|Composite Score on Glycine, Double-blind|"Glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks Double-blind~Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine"
157364|NCT01720316|O1|Outcome|Baseline|Composite Score at Baseline
157365|NCT01720316|O2|Outcome|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
157366|NCT01720316|O1|Outcome|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
157367|NCT01720316|E2|Reported Event|Placebo|"placebo, TID dosing, 6 weeks~placebo"
157368|NCT01720316|E1|Reported Event|Glycine|"Glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks~glycine powder: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine"
157369|NCT01720277|B3|Baseline|Total|Total of all reporting groups
157370|NCT01720277|B2|Baseline|Standard-dose for Residents|NH facilities randomized to receive free standard-dose trivalent influenza vaccine (Fluzone) for nursing home residents.
157371|NCT01720277|B1|Baseline|High-Dose Vaccine for Residents|NH facilities randomized to receive high dose trivalent influenza vaccine (High-dose Fluzone) for the residents.
157372|NCT01720277|P2|Participant Flow|Standard-dose for Residents|NH facilities randomized to receive free standard-dose trivalent influenza vaccine (Fluzone) for nursing home residents.
157373|NCT01720277|P1|Participant Flow|High-Dose Vaccine for Residents|NH facilities randomized to receive high dose trivalent influenza vaccine (High-dose Fluzone) for the residents.
157374|NCT01720277|O2|Outcome|SD Fluzone Vaccine|"NH facilities randomized to standard dose trivalent influenza vaccine (SD Fluzone) for the residents.~SD Fluzone Vaccine: Nursing home residents are allocated to receive standard trivalent vaccine (TIV)."
157375|NCT01720277|O1|Outcome|HD Fluzone Vaccine|"NH facilities randomized to receive high dose trivalent influenza vaccine (HD Fluzone) for the residents.~HD Fluzone Vaccine: Nursing home residents over 65 years are allocated to receive high dose trivalent vaccine. Residents under 65 years are provided standard dose trivalent vaccine (TIV)."
157376|NCT01720277|O2|Outcome|SD Fluzone Vaccine|"NH facilities randomized to standard dose trivalent influenza vaccine (SD Fluzone) for the residents.~SD Fluzone Vaccine: Nursing home residents are allocated to receive standard trivalent vaccine (TIV)."
157377|NCT01720277|O1|Outcome|HD Fluzone Vaccine|"NH facilities randomized to receive high dose trivalent influenza vaccine (HD Fluzone) for the residents.~HD Fluzone Vaccine: Nursing home residents over 65 years are allocated to receive high dose trivalent vaccine. Residents under 65 years are provided standard dose trivalent vaccine (TIV)."
157378|NCT01720277|O2|Outcome|Standard-dose for Residents|NH facilities randomized to receive free standard-dose trivalent influenza vaccine (Fluzone) for nursing home residents.
157379|NCT01720277|O1|Outcome|High-Dose Vaccine for Residents|NH facilities randomized to receive high dose trivalent influenza vaccine (High-dose Fluzone) for the residents.
157380|NCT01720277|E2|Reported Event|Standard-dose for Residents|NH facilities randomized to receive free standard-dose trivalent influenza vaccine (Fluzone) for nursing home residents.
157381|NCT01720277|E1|Reported Event|High-Dose Vaccine for Residents|NH facilities randomized to receive high dose trivalent influenza vaccine (High-dose Fluzone) for the residents.
157382|NCT01720251|B4|Baseline|Total|Total of all reporting groups
157383|NCT01720251|B3|Baseline|AllerT Full Dose|"SC injections of AllerT 50-100 micrograms~AllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56"
157384|NCT01720251|B2|Baseline|AllerT Low Dose|"SC injections of AllerT 25 or 50 micrograms~AllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56"
157385|NCT01720251|B1|Baseline|Placebo|"SC injections of placebo~placebo: SC injections of placebo on days 1, 7, 14, 28 and 56"
157386|NCT01720251|P3|Participant Flow|AllerT Full Dose|"SC injections of AllerT 50-100 micrograms~AllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56"
157389|NCT01720251|O3|Outcome|AllerT Full Dose|"SC injections of AllerT 50-100 micrograms~AllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56"
157390|NCT01720251|O2|Outcome|AllerT Low Dose|"SC injections of AllerT 25 or 50 micrograms~AllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56"
157391|NCT01720251|O1|Outcome|Placebo|"SC injections of placebo~placebo: SC injections of placebo on days 1, 7, 14, 28 and 56"
157392|NCT01720251|E3|Reported Event|AllerT 100 µg|All patients having received at least one injection of Allert 100 µg (Safety Set)
157393|NCT01720251|E2|Reported Event|Allert 50 µg|All patients having received at least one injection of Allert 50 µg (Safety Set)
157394|NCT01720251|E1|Reported Event|Placebo|All patients having received at least one injection of Placebo (Safety Set)
157395|NCT01720173|B1|Baseline|Dalantercept|"Dalantercept administered subcutaneously at a dose of 1.2mg/kg (maximum starting dose of 120 mg*) once every three weeks until disease progression or adverse effects prohibit further therapy. One cycle is 3 weeks.~*Patients weighing more than 100kg will start treatment at 120mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight."
157396|NCT01720173|P1|Participant Flow|Dalantercept|"Dalantercept administered subcutaneously at a dose of 1.2mg/kg (maximum starting dose of 120 mg*) once every three weeks until disease progression or adverse effects prohibit further therapy. One cycle is 3 weeks.~*Patients weighing more than 100kg will start treatment at 120mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight."
157397|NCT01720173|O1|Outcome|Dalantercept|"Dalantercept administered subcutaneously at a dose of 1.2mg/kg (maximum starting dose of 120 mg*) once every three weeks until disease progression or adverse effects prohibit further therapy. One cycle is 3 weeks.~*Patients weighing more than 100kg will start treatment at 120mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight."
157398|NCT01720173|O1|Outcome|Dalantercept|"Dalantercept administered subcutaneously at a dose of 1.2mg/kg (maximum starting dose of 120 mg*) once every three weeks until disease progression or adverse effects prohibit further therapy. One cycle is 3 weeks.~*Patients weighing more than 100kg will start treatment at 120mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight."
157399|NCT01720173|O1|Outcome|Dalantercept|"Dalantercept administered subcutaneously at a dose of 1.2mg/kg (maximum starting dose of 120 mg*) once every three weeks until disease progression or adverse effects prohibit further therapy. One cycle is 3 weeks.~*Patients weighing more than 100kg will start treatment at 120mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight."
157400|NCT01720173|O1|Outcome|Dalantercept|"Dalantercept administered subcutaneously at a dose of 1.2mg/kg (maximum starting dose of 120 mg*) once every three weeks until disease progression or adverse effects prohibit further therapy. One cycle is 3 weeks.~*Patients weighing more than 100kg will start treatment at 120mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight."
157401|NCT01720173|O1|Outcome|Dalantercept|"Dalantercept administered subcutaneously at a dose of 1.2mg/kg (maximum starting dose of 120 mg*) once every three weeks until disease progression or adverse effects prohibit further therapy. One cycle is 3 weeks.~*Patients weighing more than 100kg will start treatment at 120mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight."
157402|NCT01720173|E1|Reported Event|Dalantercept|"Dalantercept administered subcutaneously at a dose of 1.2mg/kg (maximum starting dose of 120 mg*) once every three weeks until disease progression or adverse effects prohibit further therapy. One cycle is 3 weeks.~*Patients weighing more than 100kg will start treatment at 120mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight."
157403|NCT01720043|B1|Baseline|All Participants|"All participants enrolled~Velcade: Single dose of Velcade (1.0-1.3 mg/m2 dose)"
157404|NCT01720043|P1|Participant Flow|All Participants|Velcade: Single dose of Velcade (1.0-1.3 mg/m2 dose)
157405|NCT01720043|O1|Outcome|All Participants|"All participants enrolled~Velcade: Single dose of Velcade (1.0-1.3 mg/m2 dose)"
157406|NCT01720043|E1|Reported Event|All Participants|"All participants enrolled~Velcade: Single dose of Velcade (1.0-1.3 mg/m2 dose)"
157407|NCT01719861|B1|Baseline|Desipramine HCl|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
157408|NCT01719861|P1|Participant Flow|Desipramine HCl 25 mg|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
157409|NCT01719861|O1|Outcome|Desipramine HCl|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
157410|NCT01719861|O1|Outcome|Desipramine HCl|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
157411|NCT01719861|O1|Outcome|Desipramine HCl|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
157500|NCT01719003|O2|Outcome|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
173041|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
157412|NCT01719861|O1|Outcome|Desipramine HCl|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
157413|NCT01719861|O1|Outcome|Desipramine HCl 25 mg|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
157414|NCT01719861|E1|Reported Event|Desipramine HCl 25 mg|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
157415|NCT01719757|B1|Baseline|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day~Oxycodone/Naloxone: Twice daily"
157416|NCT01719757|P1|Participant Flow|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day~Oxycodone/Naloxone: Twice daily"
157417|NCT01719757|O2|Outcome|Subject|For overall satisfaction assessement of oxycodone/naloxone by subject
157418|NCT01719757|O1|Outcome|Investigator|For overall satisfaction assessement of oxycodone/naloxone by investigator
157419|NCT01719757|O1|Outcome|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day~Oxycodone/Naloxone: Twice daily"
157420|NCT01719757|O1|Outcome|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day~Oxycodone/Naloxone: Twice daily"
157421|NCT01719757|O1|Outcome|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day~Oxycodone/Naloxone: Twice daily"
157422|NCT01719757|E1|Reported Event|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day~Oxycodone/Naloxone: Twice daily"
157423|NCT01719744|B1|Baseline|ENMD-2076|"ENMD-2076 capsules, 275 mg once daily, by mouth.~ENMD-2076"
157424|NCT01719744|P1|Participant Flow|ENMD-2076|"ENMD-2076 capsules, 275 mg once daily, by mouth.~ENMD-2076"
157425|NCT01719744|O1|Outcome|ENMD-2076|"ENMD-2076 capsules, 275 mg once daily, by mouth.~ENMD-2076"
157426|NCT01719744|O1|Outcome|ENMD-2076|"ENMD-2076 capsules, 275 mg once daily, by mouth.~ENMD-2076"
157427|NCT01719744|O1|Outcome|ENMD-2076|"ENMD-2076 capsules, 275 mg once daily, by mouth.~ENMD-2076"
157428|NCT01719744|E1|Reported Event|ENMD-2076|"ENMD-2076 capsules, 275 mg once daily, by mouth.~ENMD-2076"
157429|NCT01719653|B6|Baseline|Total|Total of all reporting groups
157430|NCT01719653|B5|Baseline|SUPREP (Split-Dose)|"SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.~SUPREP: SUPREP consumed as described in each arm."
157431|NCT01719653|B4|Baseline|MoviPrep (Split-Dose)|"MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.~MoviPrep: MoviPrep consumed as described in each arm."
157432|NCT01719653|B3|Baseline|MiraLAX 306 g (Split-Dose)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
157433|NCT01719653|B2|Baseline|MiraLAX 357 g (Day-Prior)|"MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
157434|NCT01719653|B1|Baseline|MiraLAX 306 g (Day-Prior)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
157435|NCT01719653|P5|Participant Flow|SUPREP (Split-Dose)|"SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.~SUPREP: SUPREP consumed as described in each arm."
157436|NCT01719653|P4|Participant Flow|MoviPrep (Split-Dose)|"MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.~MoviPrep: MoviPrep consumed as described in each arm."
157437|NCT01719653|P3|Participant Flow|MiraLAX 306 g (Split-Dose)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
157438|NCT01719653|P2|Participant Flow|MiraLAX 357 g (Day-Prior)|"MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
157501|NCT01719003|O1|Outcome|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
173042|NCT01665170|O1|Outcome|Placebo|Placebo arm
157439|NCT01719653|P1|Participant Flow|MiraLAX 306 g (Day-Prior)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
157440|NCT01719653|O5|Outcome|SUPREP (Split-Dose)|"SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.~SUPREP: SUPREP consumed as described in each arm."
157441|NCT01719653|O4|Outcome|MoviPrep (Split-Dose)|"MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.~MoviPrep: MoviPrep consumed as described in each arm."
157442|NCT01719653|O3|Outcome|MiraLAX 306 g (Split-Dose)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
157443|NCT01719653|O2|Outcome|MiraLAX 357 g (Day-Prior)|"MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
157444|NCT01719653|O1|Outcome|MiraLAX 306 g (Day-Prior)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
157445|NCT01719653|O5|Outcome|SUPREP (Split-Dose)|"SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.~SUPREP: SUPREP consumed as described in each arm."
157446|NCT01719653|O4|Outcome|MoviPrep (Split-Dose)|"MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.~MoviPrep: MoviPrep consumed as described in each arm."
157447|NCT01719653|O3|Outcome|MiraLAX 306 g (Split-Dose)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
157448|NCT01719653|O2|Outcome|MiraLAX 357 g (Day-Prior)|"MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
157449|NCT01719653|O1|Outcome|MiraLAX 306 g (Day-Prior)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
157450|NCT01719653|O5|Outcome|SUPREP (Split-Dose)|"SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.~SUPREP: SUPREP consumed as described in each arm."
157451|NCT01719653|O4|Outcome|MoviPrep (Split-Dose)|"MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.~MoviPrep: MoviPrep consumed as described in each arm."
157452|NCT01719653|O3|Outcome|MiraLAX 306 g (Split-Dose)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
157453|NCT01719653|O2|Outcome|MiraLAX 357 g (Day-Prior)|"MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
157454|NCT01719653|O1|Outcome|MiraLAX 306 g (Day-Prior)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
157455|NCT01719653|E5|Reported Event|SUPREP (Split-Dose)|"SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.~SUPREP: SUPREP consumed as described in each arm."
157456|NCT01719653|E4|Reported Event|MoviPrep (Split-Dose)|"MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.~MoviPrep: MoviPrep consumed as described in each arm."
157457|NCT01719653|E3|Reported Event|MiraLAX 306 g (Split-Dose)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
157502|NCT01719003|O8|Outcome|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
157503|NCT01719003|O7|Outcome|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
157504|NCT01719003|O6|Outcome|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
157458|NCT01719653|E2|Reported Event|MiraLAX 357 g (Day-Prior)|"MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
157459|NCT01719653|E1|Reported Event|MiraLAX 306 g (Day-Prior)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
157460|NCT01719224|B1|Baseline|Total Study Population (N=55)|Fifty-five patients were enrolled within 48 hours after delivery from two newborn family units at MGH hospital.
157461|NCT01719224|P2|Participant Flow|Experimental: Non-Elevated Position, Then Elevated Position|In the beginning of the study night, participants were placed in a non-elevated sleeping position. After 3.5h, a study member changed the patients bed to a 45 degrees upper body position. We collected data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen during the study night.
157462|NCT01719224|P1|Participant Flow|Experimental: Elevated Position, Then Non-Elevated Position|In the beginning of the study night, participants were placed in a sleeping position at 45 degrees upper body elevation. After 3.5h, a study member changed the patients bed to a non-elevated position. We collected data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen during the study night.
157463|NCT01719224|O3|Outcome|45 Degree Elevation|Fifty-five patients were enrolled within 48 hours after delivery, and all of them successfully completed acoustic pharyngometry during wakefulness. Each patient had the pharyngemtry measurements in a non-elevated (supine) position.
157464|NCT01719224|O2|Outcome|Non-elevated Position|Fifty-five patients were enrolled within 48 hours after delivery, and all of them successfully completed acoustic pharyngometry during wakefulness. Each patient had the pharyngemtry measurements in a non-elevated (supine) position.
157465|NCT01719224|O1|Outcome|Sitting Position|Fifty-five patients were enrolled within 48 hours after delivery, and all of them successfully completed acoustic pharyngometry during wakefulness. Each patient had the pharyngemtry measurements in a sitting position
157466|NCT01719224|O2|Outcome|Non-elevated Upper Body Position|"We collected data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen, by comparing supine to 45 degrees elevated body position.~Supine body position: non-elevated upper body position"
157467|NCT01719224|O1|Outcome|Elevated Upper Body Position|"We collect data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen, by comparing supine to 45 degrees elevated body position.~elevated body position: 45 degrees elevated upper body position"
157468|NCT01719224|E2|Reported Event|Supine Body Position|"We collect data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen, by comparing supine to 45 degrees elevated body position.~supine body position: non-elevated upper body position"
157469|NCT01719224|E1|Reported Event|Elevated Body Position|"We collect data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen, by comparing supine to 45 degrees elevated body position.~elevated body position: 45 degrees elevated upper body position"
157470|NCT01719172|B1|Baseline|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
157471|NCT01719172|P1|Participant Flow|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
157472|NCT01719172|O1|Outcome|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
157473|NCT01719172|O1|Outcome|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
157474|NCT01719172|O1|Outcome|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
157475|NCT01719172|E1|Reported Event|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
157476|NCT01719003|B9|Baseline|Total|Total of all reporting groups
157477|NCT01719003|B8|Baseline|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
157478|NCT01719003|B7|Baseline|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
157479|NCT01719003|B6|Baseline|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
157480|NCT01719003|B5|Baseline|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
157481|NCT01719003|B4|Baseline|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
157482|NCT01719003|B3|Baseline|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
157483|NCT01719003|B2|Baseline|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
157484|NCT01719003|B1|Baseline|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
157485|NCT01719003|P9|Participant Flow|Empagliflozin 12.5 mg Bid + Metformin 1000 mg Bid OL|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg bid in an open label (OL)
157486|NCT01719003|P8|Participant Flow|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
157487|NCT01719003|P7|Participant Flow|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
157488|NCT01719003|P6|Participant Flow|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
157489|NCT01719003|P5|Participant Flow|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
157490|NCT01719003|P4|Participant Flow|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
157491|NCT01719003|P3|Participant Flow|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
157492|NCT01719003|P2|Participant Flow|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
157493|NCT01719003|P1|Participant Flow|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
157494|NCT01719003|O8|Outcome|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
157495|NCT01719003|O7|Outcome|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
157506|NCT01719003|O4|Outcome|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
157507|NCT01719003|O3|Outcome|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
157508|NCT01719003|O2|Outcome|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
157509|NCT01719003|O1|Outcome|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
157510|NCT01719003|O8|Outcome|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
157511|NCT01719003|O7|Outcome|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
157512|NCT01719003|O6|Outcome|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
157513|NCT01719003|O5|Outcome|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
157514|NCT01719003|O4|Outcome|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
157515|NCT01719003|O3|Outcome|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
157516|NCT01719003|O2|Outcome|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
157517|NCT01719003|O1|Outcome|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
157518|NCT01719003|E9|Reported Event|Empagliflozin 12.5 mg Bid + Metformin 1000 mg Bid OL|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg bid in an open label (OL)
157519|NCT01719003|E8|Reported Event|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
157520|NCT01719003|E7|Reported Event|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
157521|NCT01719003|E6|Reported Event|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
157522|NCT01719003|E5|Reported Event|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
157523|NCT01719003|E4|Reported Event|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
157524|NCT01719003|E3|Reported Event|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
157525|NCT01719003|E2|Reported Event|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
157526|NCT01719003|E1|Reported Event|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
157527|NCT01718691|B3|Baseline|Total|Total of all reporting groups
157528|NCT01718691|B2|Baseline|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
157529|NCT01718691|B1|Baseline|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
157530|NCT01718691|P2|Participant Flow|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma.
157531|NCT01718691|P1|Participant Flow|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma.
157532|NCT01718691|O1|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
157533|NCT01718691|O1|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm.
157534|NCT01718691|O1|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
157535|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
157536|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
157537|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
157538|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
157539|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
157540|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
157541|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
157542|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
157543|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
157544|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
157545|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
157546|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
157547|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
157548|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
157549|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
157550|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
157551|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
157552|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
157553|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm.
157554|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma.
157555|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma.
157557|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
157558|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
157559|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
157560|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
157561|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
157562|NCT01718691|E1|Reported Event|SyB L-0501＋Rituximab|"Drug: SyB L-0501~A dose of 90 mg/m^2/day of SyB L-0501 is administered on Day 1 and Day 2 as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times.~Drug: rituximab~A dose of 375 mg/m^2 of rituximab is administered on Day 1 (Day 0 in Cycle 1 only) as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times. From Cycle 2, rituximab will be coadministered with SyB L-0501 on Day 1. However, if the investigator or sub-investigator judges that the coadministration is difficult, rituximab may be administered on Day 0."
157563|NCT01718535|B11|Baseline|Total|Total of all reporting groups
157564|NCT01718535|B10|Baseline|*3/*17 CYP2C19 Genotype|
157565|NCT01718535|B9|Baseline|*2/*17 CYP2C19 Genotype|
157566|NCT01718535|B8|Baseline|*2/*3 CYP2C19 Genotype|
157567|NCT01718535|B7|Baseline|*17/*17 CYP2C19 Genotype|
157568|NCT01718535|B6|Baseline|*1/*17 CYP2C19 Genotype|
157569|NCT01718535|B5|Baseline|*3/*3 CYP2C19 Genotype|
157570|NCT01718535|B4|Baseline|*1/*3 CYP2C19 Genotype|
157571|NCT01718535|B3|Baseline|*2/*2 CYP2C19 Genotype|
157572|NCT01718535|B2|Baseline|*1/*2 CYP2C19 Genotype|
157573|NCT01718535|B1|Baseline|*1/*1 CYP2C19 Genotype|
157574|NCT01718535|P10|Participant Flow|*3/*17 CYP2C19 Genotype|
157575|NCT01718535|P9|Participant Flow|*2/*17 CYP2C19 Genotype|
157576|NCT01718535|P8|Participant Flow|*2/*3 CYP2C19 Genotype|
157577|NCT01718535|P7|Participant Flow|*17/*17 CYP2C19 Genotype|
157578|NCT01718535|P6|Participant Flow|*1/*17 CYP2C19 Genotype|
157579|NCT01718535|P5|Participant Flow|*3/*3 CYP2C19 Genotype|
157580|NCT01718535|P4|Participant Flow|*1/*3 CYP2C19 Genotype|
157581|NCT01718535|P3|Participant Flow|*2/*2 CYP2C19 Genotype|
157582|NCT01718535|P2|Participant Flow|*1/*2 CYP2C19 Genotype|
157583|NCT01718535|P1|Participant Flow|*1/*1 CYP2C19 Genotype|
157584|NCT01718535|O10|Outcome|*3/*17 CYP2C19 Genotype|
157585|NCT01718535|O9|Outcome|*2/*17 CYP2C19 Genotype|
157586|NCT01718535|O8|Outcome|*2/*3 CYP2C19 Genotype|
157587|NCT01718535|O7|Outcome|*17/*17 CYP2C19 Genotype|
157588|NCT01718535|O6|Outcome|*1/*17 CYP2C19 Genotype|
157589|NCT01718535|O5|Outcome|*3/*3 CYP2C19 Genotype|
157590|NCT01718535|O4|Outcome|*1/*3 CYP2C19 Genotype|
157591|NCT01718535|O3|Outcome|*2/*2 CYP2C19 Genotype|
157592|NCT01718535|O2|Outcome|*1/*2 CYP2C19 Genotype|
157593|NCT01718535|O1|Outcome|*1/*1 CYP2C19 Genotype|
157594|NCT01718535|E10|Reported Event|*3/*17 CYP2C19 Genotype|
157595|NCT01718535|E9|Reported Event|*2/*17 CYP2C19 Genotype|
157596|NCT01718535|E8|Reported Event|*2/*3 CYP2C19 Genotype|
157597|NCT01718535|E7|Reported Event|*17/*17 CYP2C19 Genotype|
157598|NCT01718535|E6|Reported Event|*1/*17 CYP2C19 Genotype|
157599|NCT01718535|E5|Reported Event|*3/*3 CYP2C19 Genotype|
157600|NCT01718535|E4|Reported Event|*1/*3 CYP2C19 Genotype|
157601|NCT01718535|E3|Reported Event|*2/*2 CYP2C19 Genotype|
157602|NCT01718535|E2|Reported Event|*1/*2 CYP2C19 Genotype|
157603|NCT01718535|E1|Reported Event|*1/*1 CYP2C19 Genotype|
157604|NCT01718509|B3|Baseline|Total|Total of all reporting groups
157605|NCT01718509|B2|Baseline|SPD489|
157606|NCT01718509|B1|Baseline|PLACEBO|
157607|NCT01718509|P2|Participant Flow|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
157608|NCT01718509|P1|Participant Flow|PLACEBO|Administered once-daily, orally, for up to 12 weeks
157609|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
157610|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
157611|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
157612|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
157613|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
157614|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
157615|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
157616|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
157617|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
157618|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
157619|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
157620|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
157621|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
157622|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
157623|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
157624|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
157625|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
157626|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
157627|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
157652|NCT01718483|B2|Baseline|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
157653|NCT01718483|B1|Baseline|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
157654|NCT01718483|P2|Participant Flow|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 milligram (mg) administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
157655|NCT01718483|P1|Participant Flow|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily, for up to 12 weeks.
157656|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
157657|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
157658|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
157659|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
157660|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
157661|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
157662|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
157663|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
157664|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
157665|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
157666|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
157667|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
157668|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
157669|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
157670|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
157671|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
157672|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
157673|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
157674|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
157675|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
157676|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
157677|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
157678|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
157679|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
157680|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
157681|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
157682|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
157683|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
157684|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
157685|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
157686|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
157687|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
157688|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
157689|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
157690|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
157691|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
157692|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
157693|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
157694|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
157695|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
157731|NCT01718028|E1|Reported Event|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
157696|NCT01718483|E2|Reported Event|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
157697|NCT01718483|E1|Reported Event|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
157698|NCT01718353|B3|Baseline|Total|Total of all reporting groups
157699|NCT01718353|B2|Baseline|Cabazitaxel + Prednisone (Treatment B)|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of Cycle 1 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily. Participants with <30% PSA reduction from baseline at the end of Cycle 4 switched to Docetaxel 75mg/m^2 IV infusion on Day 1 of Cycle 5 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, death, unacceptable toxicity or participant’s refusal of further study treatment. Participants with ≥30% PSA reduction from baseline at the end of Cycle 4, continued on the same treatment which they received before switching until DP, death, unacceptable toxicity or participant’s refusal of further study treatment.
157700|NCT01718353|B1|Baseline|Docetaxel + Prednisone (Treatment A)|Docetaxel 75 mg/m^2 IV infusion on Day 1 of Cycle 1 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily. Participants with <30% PSA reduction from baseline at the end of Cycle 4 switched to Cabazitaxel 25mg/m^2 IV infusion on Day 1 of Cycle 5 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, death, unacceptable toxicity or participant’s refusal of further study treatment. Participants with ≥30% PSA reduction from baseline at the end of Cycle 4, continued on the same treatment which they received before switching until DP, death, unacceptable toxicity or participant’s refusal of further study treatment.
157701|NCT01718353|P2|Participant Flow|Cabazitaxel + Prednisone (Treatment B)|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of Cycle 1 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily. Participants with <30% PSA reduction from baseline at the end of Cycle 4 switched to Docetaxel 75mg/m^2 IV infusion on Day 1 of Cycle 5 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, death, unacceptable toxicity or participant’s refusal of further study treatment. Participants with ≥30% PSA reduction from baseline at the end of Cycle 4, continued on the same treatment which they received before switching until DP, death, unacceptable toxicity or participant’s refusal of further study treatment.
157702|NCT01718353|P1|Participant Flow|Docetaxel + Prednisone (Treatment A)|Docetaxel 75 mg/m^2 intravenous (IV) infusion on Day 1 of Cycle 1 and every 3 weeks (q3w) thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily. Participants with <30% prostate-specific antigen (PSA) reduction from baseline at the end of Cycle 4 switched to Cabazitaxel 25mg/m^2 IV infusion on Day 1 of Cycle 5 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily until disease progression (DP), death, unacceptable toxicity or participant’s refusal of further study treatment. Participants with ≥30% PSA reduction from baseline at the end of Cycle 4, continued on the same treatment which they received before switching until DP, death, unacceptable toxicity or participant’s refusal of further study treatment.
157703|NCT01718353|O1|Outcome|Overall Population (Treatment A or Treatment B)|Docetaxel 75 mg/m^2 or Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of Cycle 1 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily. Participants with <30% PSA reduction from baseline at the end of Cycle 4, switched to Cabazitaxel 25 mg/m^2 IV or Docetaxel 75mg/m^2 IV infusion respectively on Day 1 of Cycle 5 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, death, unacceptable toxicity or participant’s refusal of further study treatment. Participants with ≥30% PSA reduction from baseline at the end of Cycle 4, continued on the same treatment which they received before switching until DP, death, unacceptable toxicity or participant’s refusal of further study treatment.
157704|NCT01718353|O2|Outcome|Overall Population (Non AR-target Agent Treated)|Participants not having prior treatment experience with a high potency AR targeted agent (AR signaling inhibitor or CYP 17 inhibitor) before this study.
157705|NCT01718353|O1|Outcome|Overall Population (AR-target Agent Treated)|Participants having prior treatment experience with a high potency AR targeted agent (AR signaling inhibitor or CYP 17) before this study.
157706|NCT01718353|O1|Outcome|Overall Population (Treatment A or Treatment B)|Docetaxel 75 mg/m^2 or Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of Cycle 1 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily. Participants with <30% PSA reduction from baseline at the end of Cycle 4, switched to Cabazitaxel 25 mg/m^2 IV or Docetaxel 75mg/m^2 IV infusion respectively on Day 1 of Cycle 5 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, death, unacceptable toxicity or participant’s refusal of further study treatment. Participants with ≥30% PSA reduction from baseline at the end of Cycle 4, continued on the same treatment which they received before switching until DP, death, unacceptable toxicity or participant’s refusal of further study treatment.
157707|NCT01718353|O1|Outcome|Overall Population (Treatment A or Treatment B)|Docetaxel 75 mg/m^2 or Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of Cycle 1 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily. Participants with <30% PSA reduction from baseline at the end of Cycle 4, switched to Cabazitaxel 25 mg/m^2 IV or Docetaxel 75mg/m^2 IV infusion respectively on Day 1 of Cycle 5 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, death, unacceptable toxicity or participant’s refusal of further study treatment. Participants with ≥30% PSA reduction from baseline at the end of Cycle 4, continued on the same treatment which they received before switching until DP, death, unacceptable toxicity or participant’s refusal of further study treatment.
157708|NCT01718353|O1|Outcome|Overall Population (Treatment A or Treatment B)|Docetaxel 75 mg/m^2 or Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of Cycle 1 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily. Participants with <30% PSA reduction from baseline at the end of Cycle 4, switched to Cabazitaxel 25 mg/m^2 IV or Docetaxel 75mg/m^2 IV infusion respectively on Day 1 of Cycle 5 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, death, unacceptable toxicity or participant’s refusal of further study treatment. Participants with ≥30% PSA reduction from baseline at the end of Cycle 4, continued on the same treatment which they received before switching until DP, death, unacceptable toxicity or participant’s refusal of further study treatment.
157732|NCT01717989|B1|Baseline|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
157733|NCT01717989|P1|Participant Flow|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
157709|NCT01718353|O1|Outcome|Overall Population (Treatment A or Treatment B)|Docetaxel 75 mg/m^2 or Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of Cycle 1 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily. Participants with <30% PSA reduction from baseline at the end of Cycle 4, switched to Cabazitaxel 25 mg/m^2 IV or Docetaxel 75mg/m^2 IV infusion respectively on Day 1 of Cycle 5 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, death, unacceptable toxicity or participant’s refusal of further study treatment. Participants with ≥30% PSA reduction from baseline at the end of Cycle 4, continued on the same treatment which they received before switching until DP, death, unacceptable toxicity or participant’s refusal of further study treatment.
157710|NCT01718353|O1|Outcome|Overall Population (Treatment A or Treatment B)|Docetaxel 75 mg/m^2 or Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of Cycle 1 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily. Participants with <30% PSA reduction from baseline at the end of Cycle 4, switched to Cabazitaxel 25 mg/m^2 IV or Docetaxel 75mg/m^2 IV infusion respectively on Day 1 of Cycle 5 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, death, unacceptable toxicity or participant’s refusal of further study treatment. Participants with ≥30% PSA reduction from baseline at the end of Cycle 4, continued on the same treatment which they received before switching until DP, death, unacceptable toxicity or participant’s refusal of further study treatment.
157711|NCT01718353|O1|Outcome|Overall Population (Treatment A or Treatment B)|Docetaxel 75 mg/m^2 or Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of Cycle 1 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily. Participants with <30% PSA reduction from baseline at the end of Cycle 4, switched to Cabazitaxel 25 mg/m^2 IV or Docetaxel 75mg/m^2 IV infusion respectively on Day 1 of Cycle 5 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, death, unacceptable toxicity or participant’s refusal of further study treatment. Participants with ≥30% PSA reduction from baseline at the end of Cycle 4, continued on the same treatment which they received before switching until DP, death, unacceptable toxicity or participant’s refusal of further study treatment.
157712|NCT01718353|O1|Outcome|Overall Population (Treatment A or Treatment B)|Docetaxel 75 mg/m^2 or Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of Cycle 1 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily. Participants with <30% PSA reduction from baseline at the end of Cycle 4, switched to Cabazitaxel 25 mg/m^2 IV or Docetaxel 75mg/m^2 IV infusion respectively on Day 1 of Cycle 5 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, death, unacceptable toxicity or participant’s refusal of further study treatment. Participants with ≥30% PSA reduction from baseline at the end of Cycle 4, continued on the same treatment which they received before switching until DP, death, unacceptable toxicity or participant’s refusal of further study treatment.
157713|NCT01718353|O1|Outcome|Overall Population (Treatment A or Treatment B)|Docetaxel 75 mg/m^2 or Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of Cycle 1 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily. Participants with <30% PSA reduction from baseline at the end of Cycle 4, switched to Cabazitaxel 25 mg/m^2 IV or Docetaxel 75mg/m^2 IV infusion respectively on Day 1 of Cycle 5 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, death, unacceptable toxicity or participant’s refusal of further study treatment. Participants with ≥30% PSA reduction from baseline at the end of Cycle 4, continued on the same treatment which they received before switching until DP, death, unacceptable toxicity or participant’s refusal of further study treatment.
157714|NCT01718353|E3|Reported Event|Switched Population (Treatment A to B or Treatment B to A)|Docetaxel 75 mg/m^2 or Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of Cycle 1 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily. Participants with <30% PSA reduction from baseline at the end of Cycle 4 switched to Cabazitaxel 25 mg/m^2 IV or Docetaxel 75mg/m^2 IV infusion respectively on Day 1 of Cycle 5 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, death, unacceptable toxicity or participant’s refusal of further study treatment.
157715|NCT01718353|E2|Reported Event|Cabazitaxel + Prednisone (Treatment B) - Throughout|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of Cycle 1 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily. Participants with ≥30% PSA reduction from baseline at the end of Cycle 4, continued on the same treatment throughout until DP, death, unacceptable toxicity or participant’s refusal of further study treatment.
157716|NCT01718353|E1|Reported Event|Docetaxel + Prednisone (Treatment A) - Throughout|Docetaxel 75 mg/m^2 IV infusion on Day 1 of Cycle 1 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily. Participants with ≥30% PSA reduction from baseline at the end of Cycle 4, continued on the same treatment throughout until DP, death, unacceptable toxicity or participant’s refusal of further study treatment.
157717|NCT01718028|B3|Baseline|Total|Total of all reporting groups
157718|NCT01718028|B2|Baseline|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
157719|NCT01718028|B1|Baseline|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
157720|NCT01718028|P2|Participant Flow|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
157721|NCT01718028|P1|Participant Flow|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
157722|NCT01718028|O2|Outcome|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
157723|NCT01718028|O1|Outcome|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
157724|NCT01718028|O2|Outcome|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
157725|NCT01718028|O1|Outcome|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
157726|NCT01718028|O2|Outcome|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
157727|NCT01718028|O1|Outcome|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
157728|NCT01718028|O2|Outcome|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
157729|NCT01718028|O1|Outcome|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
157730|NCT01718028|E2|Reported Event|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
157789|NCT01717989|O1|Outcome|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
157790|NCT01717989|O1|Outcome|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
157791|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
157792|NCT01717989|O4|Outcome|Q3 2011|Third quarter (Q3) 2011
157793|NCT01717989|O3|Outcome|Q2 2011|Second quarter (Q2), 2011
157794|NCT01717989|O2|Outcome|Q1 2011|First quarter (Q1), 2011
157795|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter (Q4) 2010
157796|NCT01717989|O1|Outcome|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
157797|NCT01717989|E1|Reported Event|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
157798|NCT01717976|B3|Baseline|Total|Total of all reporting groups
157799|NCT01717976|B2|Baseline|Control|usual care
157800|NCT01717976|B1|Baseline|Intervention|"primary care based nurse telephone support~DISPO ED: primary care based nurse telephone support"
157801|NCT01717976|P2|Participant Flow|Control|usual care
157802|NCT01717976|P1|Participant Flow|Intervention|"primary care based nurse telephone support~DISPO ED: primary care based nurse telephone support"
157803|NCT01717976|O2|Outcome|Control|usual care
157804|NCT01717976|O1|Outcome|Intervention|"primary care based nurse telephone support~DISPO ED: primary care based nurse telephone support"
157805|NCT01717976|O2|Outcome|Control|usual care
157806|NCT01717976|O1|Outcome|Intervention|"primary care based nurse telephone support~DISPO ED: primary care based nurse telephone support"
157807|NCT01717976|O2|Outcome|Control|usual care
157808|NCT01717976|O1|Outcome|Intervention|"primary care based nurse telephone support~DISPO ED: primary care based nurse telephone support"
157809|NCT01717976|O2|Outcome|Control|usual care
157810|NCT01717976|O1|Outcome|Intervention|"primary care based nurse telephone support~DISPO ED: primary care based nurse telephone support"
157811|NCT01717976|O2|Outcome|Control|usual care
157812|NCT01717976|O1|Outcome|Intervention|"primary care based nurse telephone support~DISPO ED: primary care based nurse telephone support"
157813|NCT01717976|E2|Reported Event|Control|usual care
157814|NCT01717976|E1|Reported Event|Intervention|"primary care based nurse telephone support~DISPO ED: primary care based nurse telephone support"
157815|NCT01717898|B1|Baseline|Abiraterone/Prednisone + BEZ235|"In Phase I, a dose escalation of BEZ235 will be performed using a standard 3 + 3 design to determine the maximum tolerated dose (MTD) of BEZ235 given in combination with continuous fixed doses of Abiraterone Acetate and prednisone. This BEZ235 dose will be used in the phase II portion of the study.~BEZ235: BEZ235 - 200 mg, 300 mg, or 400 mg; po, BID. BEZ235 will be supplied in 200 mg, 300 mg, and 400 mg sachets packaged in boxes.~Prednisone: 10/mg po daily. Prednisone can be modified at the investigator’s discretion, but should not be discontinued.~Abiraterone acetate: 1000 mg, po. Abiraterone Acetate is supplied in 250 mg white tablets, four tablets are to be taken with a full glass of water on an empty stomach once daily."
157816|NCT01717898|P4|Participant Flow|Phase II|"Phase II:~BEZ235 at MTD~Prednisone 5 mg twice daily~Abiraterone 1,000 mg daily"
157817|NCT01717898|P3|Participant Flow|Phase I: BEZ235 400 mg|"Dose level 3:~400 mg BEZ235 orally (PO) twice a day (BID)~Prednisone: 10/mg po daily. Prednisone can be modified at the investigator’s discretion, but should not be discontinued.~Abiraterone acetate: 1000 mg, po."
157818|NCT01717898|P2|Participant Flow|Phase I: BEZ235 300 mg|"Dose level 2:~300 mg BEZ235 orally (PO) twice a day (BID)~Prednisone: 10/mg PO daily.~Abiraterone acetate: 1000 mg, PO daily"
157819|NCT01717898|P1|Participant Flow|Phase I: BEZ235 200 mg|"Dose level 1:~200 mg BEZ235 orally (PO) twice a day (BID)~Prednisone: 10/mg PO daily~Abiraterone acetate: 1000 mg, PO daily"
157820|NCT01717898|O1|Outcome|Phase II|"Phase II:~BEZ235 at MTD~Prednisone 5 mg twice daily~Abiraterone 1,000 mg daily"
157821|NCT01717898|O1|Outcome|Phase II|"Phase II:~BEZ235 at MTD~Prednisone 5 mg twice daily~Abiraterone 1,000 mg daily"
157822|NCT01717898|O1|Outcome|Phase II|"Phase II:~BEZ235 at MTD~Prednisone 5 mg twice daily~Abiraterone 1,000 mg daily"
157823|NCT01717898|O1|Outcome|Phase II|"Phase II:~BEZ235 at MTD~Prednisone 5 mg twice daily~Abiraterone 1,000 mg daily"
157824|NCT01717898|O2|Outcome|Abiraterone Acetate|Trough concentration of Abiraterone acetate when used in combination with BEZ235 plus Prednisone.
157825|NCT01717898|O1|Outcome|BEZ235|Trough concentration of BEZ235 when used in combination with Abiraterone plus Prednisone.
157826|NCT01717898|O4|Outcome|Phase II|"Phase II:~BEZ235 at MTD~Prednisone 5 mg twice daily~Abiraterone 1,000 mg daily"
157827|NCT01717898|O3|Outcome|Phase I: BEZ235 400 mg|"Dose level 3:~400 mg BEZ235 orally (PO) twice a day (BID)~Prednisone: 10/mg po daily. Prednisone can be modified at the investigator’s discretion, but should not be discontinued.~Abiraterone acetate: 1000 mg, po."
157828|NCT01717898|O2|Outcome|Phase I: BEZ235 300 mg|"Dose level 2:~300 mg BEZ235 orally (PO) twice a day (BID)~Prednisone: 10/mg PO daily. Prednisone can be modified at the investigator's discretion, but should not be discontinued.~Abiraterone acetate: 1000 mg, PO daily"
157829|NCT01717898|O1|Outcome|Phase I: BEZ235 200 mg|"Dose level 1:~200 mg BEZ235 orally (PO) twice a day (BID)~Prednisone: 10/mg PO daily Prednisone can be modified at the investigator's discretion, but should not be discontinued.~Abiraterone acetate: 1000 mg, PO daily"
157830|NCT01717898|O4|Outcome|Phase II|"Phase II:~BEZ235 at MTD~Prednisone 5 mg twice daily~Abiraterone 1,000 mg daily"
157831|NCT01717898|O3|Outcome|Phase I: BEZ235 400 mg|"Dose level 3:~400 mg BEZ235 orally (PO) twice a day (BID)~Prednisone: 10/mg po daily. Prednisone can be modified at the investigator’s discretion, but should not be discontinued.~Abiraterone acetate: 1000 mg, po."
157832|NCT01717898|O2|Outcome|Phase I: BEZ235 300 mg|"Dose level 2:~300 mg BEZ235 orally (PO) twice a day (BID)~Prednisone: 10/mg PO daily. Prednisone can be modified at the investigator's discretion, but should not be discontinued.~Abiraterone acetate: 1000 mg, PO daily"
157833|NCT01717898|O1|Outcome|Phase I: BEZ235 200 mg|"Dose level 1:~200 mg BEZ235 orally (PO) twice a day (BID)~Prednisone: 10/mg PO daily Prednisone can be modified at the investigator's discretion, but should not be discontinued.~Abiraterone acetate: 1000 mg, PO daily"
157834|NCT01717898|O4|Outcome|Phase II|"Phase II:~BEZ235 at MTD~Prednisone 5 mg twice daily~Abiraterone 1,000 mg daily"
173043|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
157835|NCT01717898|O3|Outcome|Phase I: BEZ235 400 mg|"Dose level 3:~400 mg BEZ235 orally (PO) twice a day (BID)~Prednisone: 10/mg po daily. Prednisone can be modified at the investigator’s discretion, but should not be discontinued.~Abiraterone acetate: 1000 mg, po."
157836|NCT01717898|O2|Outcome|Phase I: BEZ235 300 mg|"Dose level 2:~300 mg BEZ235 orally (PO) twice a day (BID)~Prednisone: 10/mg PO daily. Prednisone can be modified at the investigator's discretion, but should not be discontinued.~Abiraterone acetate: 1000 mg, PO daily"
157837|NCT01717898|O1|Outcome|Phase I: BEZ235 200 mg|"Dose level 1:~200 mg BEZ235 orally (PO) twice a day (BID)~Prednisone: 10/mg PO daily Prednisone can be modified at the investigator's discretion, but should not be discontinued.~Abiraterone acetate: 1000 mg, PO daily"
157838|NCT01717898|O4|Outcome|Phase II|"Phase II:~BEZ235 at MTD~Prednisone 5 mg twice daily~Abiraterone 1,000 mg daily"
157839|NCT01717898|O3|Outcome|Phase I: BEZ235 400 mg|"Dose level 3:~400 mg BEZ235 orally (PO) twice a day (BID)~Prednisone: 10/mg po daily. Prednisone can be modified at the investigator’s discretion, but should not be discontinued.~Abiraterone acetate: 1000 mg, po."
157840|NCT01717898|O2|Outcome|Phase I: BEZ235 300 mg|"Dose level 2:~300 mg BEZ235 orally (PO) twice a day (BID)~Prednisone: 10/mg PO daily. Prednisone can be modified at the investigator's discretion, but should not be discontinued.~Abiraterone acetate: 1000 mg, PO daily"
157841|NCT01717898|O1|Outcome|Phase I: BEZ235 200 mg|"Dose level 1:~200 mg BEZ235 orally (PO) twice a day (BID)~Prednisone: 10/mg PO daily Prednisone can be modified at the investigator's discretion, but should not be discontinued.~Abiraterone acetate: 1000 mg, PO daily"
157842|NCT01717898|E1|Reported Event|Phase I: Abiraterone/Prednisone + BEZ235 200 mg|Study was terminated during Phase I, Dose level 1 due to toxicity.
157843|NCT01717872|B3|Baseline|Total|Total of all reporting groups
157844|NCT01717872|B2|Baseline|Miller Laryngoscope Blade|"A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
157845|NCT01717872|B1|Baseline|Macintosh Laryngoscope Blade|"A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
157846|NCT01717872|P2|Participant Flow|Miller Laryngoscope Blade|"A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
157847|NCT01717872|P1|Participant Flow|Macintosh Laryngoscope Blade|"A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
157848|NCT01717872|O2|Outcome|MAC Blade Lifting the Epiglottis|The MAC blade was inserted under the epiglottis and lift to view the percent glottic opening
157849|NCT01717872|O1|Outcome|MAC Blade Lifting the Tongue|The MAC blade was inserted under the tongue and lifted to view the percent glottic opening
157850|NCT01717872|O2|Outcome|Miller Blade Lifting the Tongue|Miller blade was inserted under the tongue (above the epiglottis) to view the glottic opening
157851|NCT01717872|O1|Outcome|Miller Blade Lifting the Epiglottis|Miller blade was inserted under the epiglottis to lift it to view the glottic opening
157852|NCT01717872|O2|Outcome|Miller Laryngoscope Blade|"A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
157853|NCT01717872|O1|Outcome|Macintosh Laryngoscope Blade|"A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The percent of glottic opening (POGO) score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
157854|NCT01717872|E2|Reported Event|Miller Laryngoscope Blade|"A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
157855|NCT01717872|E1|Reported Event|Macintosh Laryngoscope Blade|"A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
157856|NCT01717768|B11|Baseline|Total|Total of all reporting groups
157857|NCT01717768|B10|Baseline|Part 4 Cohort 4: 120 mg BID|"Oral TSX-002 120 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157858|NCT01717768|B9|Baseline|Part 4 Cohort 3: 180 mg QD|"Oral TSX-002 180 mg once daily (QD) for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157859|NCT01717768|B8|Baseline|Part 4 Cohort 2: 90 mg BID/ 90 mg TID|"Oral TSX-002 90 mg BID for 15 days then 90 mg TID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157860|NCT01717768|B7|Baseline|Part 4 Cohort 1: 60 mg BID/ 60 mg TID|"Oral TSX-002 60 mg BID for 15 days then 60 mg TID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157878|NCT01717768|P1|Participant Flow|Part 1: 120 mg BID|"Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
158177|NCT01717326|B6|Baseline|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
157861|NCT01717768|B6|Baseline|Part 3: C-A-B 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157862|NCT01717768|B5|Baseline|Part 3: B-C-A 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157863|NCT01717768|B4|Baseline|Part 3: A-B-C 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157864|NCT01717768|B3|Baseline|Part 2: 120 mg BID|"Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157865|NCT01717768|B2|Baseline|Part 1: 240 mg BID|"Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157866|NCT01717768|B1|Baseline|Part 1: 120 mg BID|"Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157867|NCT01717768|P12|Participant Flow|Part 4 Cohort 4: 120 mg BID|"Oral TSX-002 120 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157868|NCT01717768|P11|Participant Flow|Part 4 Cohort 3: 180 mg QD|"Oral TSX-002 180 mg once daily (QD) for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157869|NCT01717768|P10|Participant Flow|Part 4 Cohort 2: 90 mg TID|Oral TSX-002 90 mg TID for 15 days
157870|NCT01717768|P9|Participant Flow|Part 4 Cohort 2: 90 mg BID|"Oral TSX-002 90 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157871|NCT01717768|P8|Participant Flow|Part 4 Cohort 1: 60 mg TID|"Oral TSX-002 60 mg TID for 15 days~TSX-002 are capsules with testosterone as the active ingredient."
157872|NCT01717768|P7|Participant Flow|Part 4 Cohort 1: 60 mg BID|"Oral TSX-002 60 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157873|NCT01717768|P6|Participant Flow|Part 3: C-A-B 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing."
157874|NCT01717768|P5|Participant Flow|Part 3: B-C-A 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing."
157875|NCT01717768|P4|Participant Flow|Part 3: A-B-C 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157876|NCT01717768|P3|Participant Flow|Part 2: 120 mg BID|"Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157877|NCT01717768|P2|Participant Flow|Part 1: 240 mg BID|"Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
158514|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
157879|NCT01717768|O3|Outcome|Part 3:120 mg QD Treatment C|Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
157880|NCT01717768|O2|Outcome|Part 3:120 mg QD Treatment B|Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
157881|NCT01717768|O1|Outcome|Part 3:120 mg QD Treatment A|Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
157882|NCT01717768|O3|Outcome|Part 3:120 mg QD Treatment C|Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
157883|NCT01717768|O2|Outcome|Part 3:120 mg QD Treatment B|Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
157884|NCT01717768|O1|Outcome|Part 3:120 mg QD Treatment A|Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
157885|NCT01717768|O9|Outcome|Part 4 Cohort 4: 120 mg BID|"Oral TSX-002 120 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157886|NCT01717768|O8|Outcome|Part 4 Cohort 3: 180 mg QD|"Oral TSX-002 180 mg once daily (QD) for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157887|NCT01717768|O7|Outcome|Part 4 Cohort 2: 90 mg TID|"Oral TSX-002 90 mg TID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157888|NCT01717768|O6|Outcome|Part 4 Cohort 2: 90 mg BID|"Oral TSX-002 90 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157889|NCT01717768|O5|Outcome|Part 4 Cohort 1: 60 mg TID|Oral TSX-002 60 mg three times daily (TID) for 15 days
157890|NCT01717768|O4|Outcome|Part 4 Cohort 1: 60 mg BID|"Oral TSX-002 60 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157891|NCT01717768|O3|Outcome|Part 2: 120 mg BID|"Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157892|NCT01717768|O2|Outcome|Part 1: 240 mg BID|"Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157893|NCT01717768|O1|Outcome|Part 1: 120 mg BID|"Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157894|NCT01717768|O9|Outcome|Part 4 Cohort 4: 120 mg BID|"Oral TSX-002 120 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157895|NCT01717768|O8|Outcome|Part 4 Cohort 3: 180 mg QD|"Oral TSX-002 180 mg once daily (QD) for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157896|NCT01717768|O7|Outcome|Part 4 Cohort 2: 90 mg TID|"Oral TSX-002 90 mg TID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157897|NCT01717768|O6|Outcome|Part 4 Cohort 2: 90 mg BID|"Oral TSX-002 90 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157898|NCT01717768|O5|Outcome|Part 4 Cohort 1: 60 mg TID|Oral TSX-002 60 mg three times daily (TID) for 15 days
157899|NCT01717768|O4|Outcome|Part 4 Cohort 1: 60 mg BID|"Oral TSX-002 60 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157900|NCT01717768|O3|Outcome|Part 2: 120 mg BID|"Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157901|NCT01717768|O2|Outcome|Part 1: 240 mg BID|"Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157902|NCT01717768|O1|Outcome|Part 1: 120 mg BID|"Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157903|NCT01717768|E12|Reported Event|Part 4 Cohort 4: 120 mg BID|"Oral TSX-002 120 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157904|NCT01717768|E11|Reported Event|Part 4 Cohort 3: 180 mg QD|"Oral TSX-002 180 mg once daily (QD) for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157905|NCT01717768|E10|Reported Event|Part 4 Cohort 2: 90 mg TID|"Oral TSX-002 90 mg TID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157906|NCT01717768|E9|Reported Event|Part 4 Cohort 2: 90 mg BID|"Oral TSX-002 90 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157907|NCT01717768|E8|Reported Event|Part 4 Cohort 1: 60 mg TID|"Oral TSX-002 60 mg TID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157908|NCT01717768|E7|Reported Event|Part 4 Cohort 1: 60 mg BID|"Oral TSX-002 60 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157909|NCT01717768|E6|Reported Event|Part 3: C-A-B 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157957|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157910|NCT01717768|E5|Reported Event|Part 3: B-C-A 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157911|NCT01717768|E4|Reported Event|Part 3: A-B-C 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157912|NCT01717768|E3|Reported Event|Part 2: 120 mg BID|"Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157913|NCT01717768|E2|Reported Event|Part 1: 240 mg BID|"Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157914|NCT01717768|E1|Reported Event|Part 1: 120 mg BID|"Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
157915|NCT01717638|B14|Baseline|Total|Total of all reporting groups
157916|NCT01717638|B13|Baseline|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
157917|NCT01717638|B12|Baseline|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157918|NCT01717638|B11|Baseline|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157919|NCT01717638|B10|Baseline|B12 14_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157920|NCT01717638|B9|Baseline|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157921|NCT01717638|B8|Baseline|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157922|NCT01717638|B7|Baseline|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157923|NCT01717638|B6|Baseline|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157924|NCT01717638|B5|Baseline|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157925|NCT01717638|B4|Baseline|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157926|NCT01717638|B3|Baseline|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157927|NCT01717638|B2|Baseline|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157928|NCT01717638|B1|Baseline|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157929|NCT01717638|P13|Participant Flow|B48_50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
157930|NCT01717638|P12|Participant Flow|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157931|NCT01717638|P11|Participant Flow|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157932|NCT01717638|P10|Participant Flow|B12 14_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158082|NCT01717456|B3|Baseline|Total|Total of all reporting groups
157933|NCT01717638|P9|Participant Flow|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157934|NCT01717638|P8|Participant Flow|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157935|NCT01717638|P7|Participant Flow|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157936|NCT01717638|P6|Participant Flow|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157937|NCT01717638|P5|Participant Flow|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157938|NCT01717638|P4|Participant Flow|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157939|NCT01717638|P3|Participant Flow|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157940|NCT01717638|P2|Participant Flow|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157941|NCT01717638|P1|Participant Flow|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157942|NCT01717638|O1|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
157943|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157944|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157945|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157946|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157947|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157948|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157949|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157950|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157951|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157952|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157953|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157954|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157955|NCT01717638|O2|Outcome|B48 50 (After 2nd Dose)|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
157956|NCT01717638|O1|Outcome|B48 50 (After 1st Dose)|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
173044|NCT01665170|O1|Outcome|Placebo|Placebo arm
157958|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157959|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157960|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157961|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157962|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157963|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157964|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157965|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157966|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157967|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157968|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157969|NCT01717638|O1|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
157970|NCT01717638|O1|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
157971|NCT01717638|O1|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
157972|NCT01717638|O1|Outcome|B48_50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
157973|NCT01717638|O4|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
157974|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157975|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157976|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157977|NCT01717638|O4|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
157978|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157979|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157980|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157981|NCT01717638|O4|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
157982|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157983|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157984|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157985|NCT01717638|O4|Outcome|B48_50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
173045|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
157986|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157987|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157988|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157989|NCT01717638|O10|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
157990|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157991|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157992|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157993|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157994|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157995|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157996|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157997|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157998|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
157999|NCT01717638|O10|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
158000|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158001|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158002|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158003|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158004|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158005|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158006|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158007|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158008|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158009|NCT01717638|O10|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
158083|NCT01717456|B2|Baseline|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158010|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158011|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158012|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158013|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158014|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158015|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158016|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158017|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158018|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158019|NCT01717638|O10|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
158020|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158021|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158022|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158023|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158024|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158025|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158026|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158027|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158028|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158029|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158030|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158031|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158032|NCT01717638|O4|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
158033|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
162030|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
158034|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158035|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158036|NCT01717638|O4|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
158037|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158038|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158039|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158040|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158041|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158042|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158043|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158044|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158045|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158046|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158047|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158048|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158049|NCT01717638|O10|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
158050|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158051|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158052|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158053|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158054|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158055|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158056|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158057|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158649|NCT01716455|P1|Participant Flow|SSP-004184 (Mild Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
158058|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158059|NCT01717638|O10|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
158060|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158061|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158062|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158063|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158064|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158065|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158066|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158067|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158068|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158069|NCT01717638|E13|Reported Event|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
158070|NCT01717638|E12|Reported Event|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158071|NCT01717638|E11|Reported Event|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158072|NCT01717638|E10|Reported Event|B12 14_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158073|NCT01717638|E9|Reported Event|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158074|NCT01717638|E8|Reported Event|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158075|NCT01717638|E7|Reported Event|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158076|NCT01717638|E6|Reported Event|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158077|NCT01717638|E5|Reported Event|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158078|NCT01717638|E4|Reported Event|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158079|NCT01717638|E3|Reported Event|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158080|NCT01717638|E2|Reported Event|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158081|NCT01717638|E1|Reported Event|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
158084|NCT01717456|B1|Baseline|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158085|NCT01717456|P2|Participant Flow|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158086|NCT01717456|P1|Participant Flow|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [Miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
158087|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158088|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158089|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158090|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158091|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158092|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158093|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158094|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158095|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158096|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158097|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158098|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158099|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158100|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158101|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158102|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158103|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158104|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158105|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158174|NCT01717326|B9|Baseline|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158106|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158107|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158108|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158109|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158110|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158111|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158112|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158113|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158114|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158115|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158116|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158117|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158118|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158119|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158120|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158121|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158122|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158123|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158124|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158125|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158126|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158127|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158175|NCT01717326|B8|Baseline|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158650|NCT01716455|O6|Outcome|SSP-004184 (Healthy Elderly Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
158128|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158129|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158130|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158131|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158132|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158133|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158134|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158135|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158136|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
158137|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158138|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
158139|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158140|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158141|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158142|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158143|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158144|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158145|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158146|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158147|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158148|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158149|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158176|NCT01717326|B7|Baseline|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158150|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
158151|NCT01717456|E2|Reported Event|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
158152|NCT01717456|E1|Reported Event|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [Mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
158153|NCT01717391|B1|Baseline|FLT PET/CT|"FLT PET/CT imaging ordered pre-radiation therapy, during weeks 1 and 2 of radiation therapy, and then at 1 month and 12 months after radiation therapy. The FLT PET/CT imaging ordered pre-radiation therapy is used for bone marrow sparing IMRT radiation therapy.~Fluorothymidine F 18: A patient-specific bone marrow map will be designed from the pre-therapy FLT PET/CT imaging. A highly conformal radiation plan will be designed to spare active bone marrow."
158154|NCT01717391|P1|Participant Flow|FLT PET/CT|"FLT PET/CT imaging ordered pre-radiation therapy, during weeks 1 and 2 of radiation therapy, and then at 1 month and 12 months after radiation therapy. The FLT PET/CT imaging ordered pre-radiation therapy is used for bone marrow sparing IMRT radiation therapy.~Fluorothymidine F 18: A patient-specific bone marrow map will be designed from the pre-therapy FLT PET/CT imaging. A highly conformal radiation plan will be designed to spare active bone marrow."
158155|NCT01717391|O1|Outcome|Bone-marrow Sparing Radiation Therapy (IMRT)|Participants who have undergone the FLT PET/CT imaging ordered pre-radiation therapy to create a patient-specific bone marrow map to spare active bone marrow.
158156|NCT01717391|O1|Outcome|Bone-marrow Sparing Radiation Therapy (IMRT)|Participants who have undergone the FLT PET/CT imaging ordered pre-radiation therapy to create a patient-specific bone marrow map to spare active bone marrow.
158157|NCT01717391|O1|Outcome|Bone-marrow Sparing Radiation Therapy (IMRT)|Participants who have undergone the FLT PET/CT imaging ordered pre-radiation therapy to create a patient-specific bone marrow map to spare active bone marrow.
158158|NCT01717391|O1|Outcome|Bone-marrow Sparing Radiation Therapy (IMRT)|Participants who have undergone the FLT PET/CT imaging ordered pre-radiation therapy to create a patient-specific bone marrow map to spare active bone marrow.
158159|NCT01717391|O1|Outcome|FLT PET/CT|"FLT PET/CT imaging ordered pre-radiation therapy, during weeks 1 and 2 of radiation therapy, and then at 1 month and 12 months after radiation therapy. The FLT PET/CT imaging ordered pre-radiation therapy is used for bone marrow sparing IMRT radiation therapy.~Fluorothymidine F 18: A patient-specific bone marrow map will be designed from the pre-therapy FLT PET/CT imaging. A highly conformal radiation plan will be designed to spare active bone marrow."
158160|NCT01717391|O1|Outcome|Basline FLT PET/CT (All Subjects)|FLT PET/CT imaging ordered pre-radiation therapy to create a patient-specific bone marrow map to spare active bone marrow.
158161|NCT01717391|E1|Reported Event|FLT PET/CT|"FLT PET/CT imaging ordered pre-radiation therapy, during weeks 1 and 2 of radiation therapy, and then at 1 month and 12 months after radiation therapy. The FLT PET/CT imaging ordered pre-radiation therapy is used for bone marrow sparing IMRT radiation therapy.~Fluorothymidine F 18: A patient-specific bone marrow map will be designed from the pre-therapy FLT PET/CT imaging. A highly conformal radiation plan will be designed to spare active bone marrow."
158162|NCT01717326|B21|Baseline|Total|Total of all reporting groups
158163|NCT01717326|B20|Baseline|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158164|NCT01717326|B19|Baseline|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158165|NCT01717326|B18|Baseline|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
158166|NCT01717326|B17|Baseline|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158167|NCT01717326|B16|Baseline|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158168|NCT01717326|B15|Baseline|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158169|NCT01717326|B14|Baseline|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158170|NCT01717326|B13|Baseline|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158171|NCT01717326|B12|Baseline|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158172|NCT01717326|B11|Baseline|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158173|NCT01717326|B10|Baseline|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158178|NCT01717326|B5|Baseline|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158179|NCT01717326|B4|Baseline|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158180|NCT01717326|B3|Baseline|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158181|NCT01717326|B2|Baseline|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158182|NCT01717326|B1|Baseline|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158183|NCT01717326|P20|Participant Flow|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158184|NCT01717326|P19|Participant Flow|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158185|NCT01717326|P18|Participant Flow|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
158186|NCT01717326|P17|Participant Flow|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158187|NCT01717326|P16|Participant Flow|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158188|NCT01717326|P15|Participant Flow|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158189|NCT01717326|P14|Participant Flow|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158190|NCT01717326|P13|Participant Flow|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158191|NCT01717326|P12|Participant Flow|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158192|NCT01717326|P11|Participant Flow|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158193|NCT01717326|P10|Participant Flow|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158194|NCT01717326|P9|Participant Flow|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158195|NCT01717326|P8|Participant Flow|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158196|NCT01717326|P7|Participant Flow|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158197|NCT01717326|P6|Participant Flow|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158198|NCT01717326|P5|Participant Flow|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158199|NCT01717326|P4|Participant Flow|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158200|NCT01717326|P3|Participant Flow|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158201|NCT01717326|P2|Participant Flow|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158227|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158202|NCT01717326|P1|Participant Flow|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158203|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158204|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158205|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
158206|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158207|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158208|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158209|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158210|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158211|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158212|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158213|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158214|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158215|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158216|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158217|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158218|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158219|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158220|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158221|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158222|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158223|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158224|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158225|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
158226|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
173046|NCT01665170|O1|Outcome|Placebo|Placebo arm
158228|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158229|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158230|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158231|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158232|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158233|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158234|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158235|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158236|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158237|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158238|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158239|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158240|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158241|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158242|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158243|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158244|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158245|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
158246|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158247|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158248|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158249|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158250|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158251|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158252|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158253|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158254|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158255|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158256|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158257|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158258|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158259|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158260|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158261|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158262|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158263|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158264|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158265|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
158266|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158267|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158268|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158269|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158270|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158271|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158272|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158273|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158274|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158275|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158276|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158277|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158278|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158457|NCT01717326|E6|Reported Event|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158279|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158280|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158281|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158282|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158283|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158284|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158285|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
158286|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158287|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158288|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158289|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158290|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158291|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158292|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158293|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158294|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158295|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158296|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158297|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158298|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158299|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158300|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158301|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158302|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158303|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158304|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158305|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
158306|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158307|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158308|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158309|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158310|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158311|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158312|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158313|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158314|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158315|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158316|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158317|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158318|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158319|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158320|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158321|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158322|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158323|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158324|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158325|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
158326|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158327|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158328|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158329|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158330|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158331|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158332|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158333|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158334|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158335|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158336|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158337|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158338|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158339|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158340|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158341|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158342|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158343|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158344|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158345|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
158346|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158347|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158348|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158349|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158350|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158351|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158352|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158353|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158354|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158355|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158356|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158357|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158358|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158359|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158360|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158361|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158362|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158363|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158364|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158365|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
158366|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158367|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158368|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158369|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158370|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158371|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158372|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158373|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158374|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158375|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158376|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158377|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158378|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158379|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158380|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158512|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
158381|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158382|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158383|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158384|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158385|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
158386|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158387|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158388|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158389|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158390|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158391|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158392|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158393|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158394|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158395|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158396|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158397|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158398|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158399|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158400|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158401|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158402|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158403|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158404|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158405|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
158406|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158407|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158408|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158409|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158410|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158411|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158412|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158413|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158414|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158415|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158416|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158417|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158418|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158419|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158420|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158421|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158422|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158423|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158424|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158425|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
158426|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158427|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158428|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158429|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158430|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158431|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158432|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158433|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158434|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158435|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158436|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158437|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158438|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158439|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158440|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158441|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158442|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158443|NCT01717326|E20|Reported Event|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158444|NCT01717326|E19|Reported Event|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158445|NCT01717326|E18|Reported Event|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
158446|NCT01717326|E17|Reported Event|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158447|NCT01717326|E16|Reported Event|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158448|NCT01717326|E15|Reported Event|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158449|NCT01717326|E14|Reported Event|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158450|NCT01717326|E13|Reported Event|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158451|NCT01717326|E12|Reported Event|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158452|NCT01717326|E11|Reported Event|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158453|NCT01717326|E10|Reported Event|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
158454|NCT01717326|E9|Reported Event|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158455|NCT01717326|E8|Reported Event|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158456|NCT01717326|E7|Reported Event|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158651|NCT01716455|O5|Outcome|SSP-004184 (Matched Healthy Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
158458|NCT01717326|E5|Reported Event|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158459|NCT01717326|E4|Reported Event|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158460|NCT01717326|E3|Reported Event|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
158461|NCT01717326|E2|Reported Event|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158462|NCT01717326|E1|Reported Event|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
158463|NCT01717313|B3|Baseline|Total|Total of all reporting groups
158464|NCT01717313|B2|Baseline|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158465|NCT01717313|B1|Baseline|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158466|NCT01717313|P2|Participant Flow|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158467|NCT01717313|P1|Participant Flow|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158468|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158469|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158470|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158471|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158472|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158473|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158474|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158475|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158476|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158477|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158478|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158479|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158480|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158481|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158482|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158483|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158484|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158485|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158486|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158487|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158488|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158489|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158490|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158513|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
173047|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
158491|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158492|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158493|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158494|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158495|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158496|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158497|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158498|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158499|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158500|NCT01717313|E2|Reported Event|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158501|NCT01717313|E1|Reported Event|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
158502|NCT01717287|B3|Baseline|Total|Total of all reporting groups
158503|NCT01717287|B2|Baseline|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
158504|NCT01717287|B1|Baseline|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks.
158505|NCT01717287|P2|Participant Flow|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
158506|NCT01717287|P1|Participant Flow|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks.
158507|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
158508|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
158509|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
158510|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
158511|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
158652|NCT01716455|O4|Outcome|SSP-004184 (End Stage Renal Disease)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
158515|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
158516|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
158517|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
158518|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
158519|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
158520|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
158521|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
158522|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
158523|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
158524|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
158525|NCT01717287|E2|Reported Event|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
158526|NCT01717287|E1|Reported Event|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks.
158527|NCT01717209|B1|Baseline|Combined Nitric Oxide and Prostacyclin|iNO (20 ppm continuously) and iPGI2 (0.05 micrograms/kg/min continuously)
158528|NCT01717209|P1|Participant Flow|Combined Nitric Oxide and Prostacyclin|Inhaled nitric oxide (iNO; 20 ppm continuously) and inhaled prostacyclin (iPGI2; 0.05 micrograms/kg/min continuously)
158529|NCT01717209|O1|Outcome|Combined Nitric Oxide and Prostacyclin|iNO (20 ppm continuously) and iPGI2 (0.05 micrograms/kg/min continuously)
158530|NCT01717209|O1|Outcome|Combined Nitric Oxide and Prostacyclin|iNO (20 ppm continuously) and iPGI2 (0.05 micrograms/kg/min continuously)
158531|NCT01717209|O1|Outcome|Combined Nitric Oxide and Prostacyclin|iNO (20 ppm continuously) and iPGI2 (0.05 micrograms/kg/min continuously)
158532|NCT01717209|O1|Outcome|Combined Nitric Oxide and Prostacyclin|iNO (20 ppm continuously) and iPGI2 (0.05 micrograms/kg/min continuously)
158533|NCT01717209|O1|Outcome|Combined Nitric Oxide and Prostacyclin|iNO (20 ppm continuously) and iPGI2 (0.05 micrograms/kg/min continuously)
158534|NCT01717209|O1|Outcome|Combined Nitric Oxide and Prostacyclin|iNO (20 ppm continuously) and iPGI2 (0.05 micrograms/kg/min continuously)
158535|NCT01717209|E1|Reported Event|Combined Nitric Oxide and Prostacyclin|iNO (20 ppm continuously) and iPGI2 (0.05 micrograms/kg/min continuously)
158536|NCT01717040|B3|Baseline|Total|Total of all reporting groups
158537|NCT01717040|B2|Baseline|Placebo|Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
158538|NCT01717040|B1|Baseline|Pioglitazone|Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
158539|NCT01717040|P2|Participant Flow|Placebo|Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
158540|NCT01717040|P1|Participant Flow|Pioglitazone|Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
158541|NCT01717040|O2|Outcome|Placebo|Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
158542|NCT01717040|O1|Outcome|Pioglitazone|Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
158543|NCT01717040|E2|Reported Event|Placebo|Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
158544|NCT01717040|E1|Reported Event|Pioglitazone|Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
158545|NCT01717014|B1|Baseline|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
158546|NCT01717014|P1|Participant Flow|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
158547|NCT01717014|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
158548|NCT01717014|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
158549|NCT01717014|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
158550|NCT01717014|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
158551|NCT01717014|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
158552|NCT01717014|E1|Reported Event|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
158553|NCT01716754|B5|Baseline|Total|Total of all reporting groups
158554|NCT01716754|B4|Baseline|Placebo Total|Participants received matching placebo to QGE031 or Omalizumab.
158555|NCT01716754|B3|Baseline|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
158556|NCT01716754|B2|Baseline|QGE031 Low Dose|Participants received QGE031 36 mg q2w or 18 mg q2w.
158557|NCT01716754|B1|Baseline|QGE031 High Dose|Participants received QGE031 240 mg q2w, 240 mg q4w, 180 mg q2w or 120 mg q2w.
158558|NCT01716754|P4|Participant Flow|Placebo Total|Participants received matching placebo to QGE031 or Omalizumab.
158559|NCT01716754|P3|Participant Flow|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
158560|NCT01716754|P2|Participant Flow|QGE031 Low Dose|Participants received QGE031 36 mg q2w or 18 mg q2w.
158561|NCT01716754|P1|Participant Flow|QGE031 High Dose|Participants received QGE031 240 mg q2w, 240 mg q4w, 180 mg q2w or 120 mg q2w.
158562|NCT01716754|O3|Outcome|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
158563|NCT01716754|O2|Outcome|Placebo to QGE031 240 mg q2w|Participants received placebo to QGE031 240 mg q2w
158564|NCT01716754|O1|Outcome|QGE031 240 mg q2w|Participants received QGE031 240 mg q2w.
158565|NCT01716754|O3|Outcome|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
158566|NCT01716754|O2|Outcome|Placebo to QGE031 240 mg q2w|Participants received placebo to QGE031 240 mg q2w
158567|NCT01716754|O1|Outcome|QGE031 240 mg q2w|Participants received QGE031 240 mg q2w.
158568|NCT01716754|O3|Outcome|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
158569|NCT01716754|O2|Outcome|Placebo to QGE031 240 mg q2w|Participants received placebo to QGE031 240 mg q2w
158570|NCT01716754|O1|Outcome|QGE031 240 mg q2w|Participants received QGE031 240 mg q2w.
158571|NCT01716754|O3|Outcome|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
158572|NCT01716754|O2|Outcome|Placebo to QGE031 240 mg q2w|Participants received placebo to QGE031 240 mg q2w
158573|NCT01716754|O1|Outcome|QGE031 240 mg q2w|Participants received QGE031 240 mg q2w.
158574|NCT01716754|O3|Outcome|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
158575|NCT01716754|O2|Outcome|Placebo to QGE031 240 mg q2w|Participants received placebo to QGE031 240 mg q2w
158576|NCT01716754|O1|Outcome|QGE031 240 mg q2w|Participants received QGE031 240 mg q2w.
158577|NCT01716754|E4|Reported Event|Placebo Total|Participants received matching placebo to QGE031 or Omalizumab
158578|NCT01716754|E3|Reported Event|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
158579|NCT01716754|E2|Reported Event|QGE031 Low Dose|Participants received QGE031 36 mg q2w or 18 mg q2w.
158580|NCT01716754|E1|Reported Event|QGE031 High Dose|Participants received QGE031 240 mg q2w, 240 mg q4w, 180 mg q2w or 120 mg q2w.
158581|NCT01716663|B1|Baseline|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
158582|NCT01716663|P1|Participant Flow|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
158583|NCT01716663|O1|Outcome|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
158584|NCT01716663|O1|Outcome|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
158585|NCT01716663|O1|Outcome|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
158586|NCT01716663|O1|Outcome|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
158587|NCT01716663|O1|Outcome|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
158616|NCT01716520|P3|Participant Flow|Sequence 3: UMEC/VI 62.5/25 µg, UMEC 62.5 µg, VI 25 µg|Participants received UMEC/VI 62.5/25 µg, UMEC 62.5 µg, and VI 25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
158588|NCT01716663|E1|Reported Event|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
158589|NCT01716585|B3|Baseline|Total|Total of all reporting groups
158590|NCT01716585|B2|Baseline|Placebo|Double-blind placebo for 12 weeks
158591|NCT01716585|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
158592|NCT01716585|P2|Participant Flow|Placebo Followed by ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind placebo for 12 weeks followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
158593|NCT01716585|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
158594|NCT01716585|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
158595|NCT01716585|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
158596|NCT01716585|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
158597|NCT01716585|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
158598|NCT01716585|O2|Outcome|Placebo|Double-blind placebo for 12 weeks
158599|NCT01716585|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
158600|NCT01716585|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
158601|NCT01716585|E3|Reported Event|Open Label ABT-450/r/ABT-267 and ABT-333, Plus RBV|Open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
158602|NCT01716585|E2|Reported Event|Double Blind Placebo|Double-blind placebo for 12 weeks
158603|NCT01716585|E1|Reported Event|Double Blind ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
158604|NCT01716559|B1|Baseline|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
158605|NCT01716559|P1|Participant Flow|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta (NeoRecormon) subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
158606|NCT01716559|O1|Outcome|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
158607|NCT01716559|O1|Outcome|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
158608|NCT01716559|O1|Outcome|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
158609|NCT01716559|O1|Outcome|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
158610|NCT01716559|O1|Outcome|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
158611|NCT01716559|E1|Reported Event|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
158612|NCT01716520|B1|Baseline|UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg|All participants received one of the following three treatments in one of three treatment periods QD from the DPI for 14 days: UMEC 62.5 µg inhalation powder; VI 25 µg inhalation powder; and UMEC/VI 62.5/25 µg inhalation powder. Participants were randomized to receive treatment in one of the six following sequences: (1) UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg; (2) VI 25 µg, UMEC/VI 62.5/25 µg, UMEC 62.5 µg; (3) UMEC/VI 62.5/25 µg, UMEC 62.5 µg, VI 25 µg; (4) UMEC 62.5 µg, UMEC/VI 62.5/25 µg, VI 25 µg; (5) VI 25 µg, UMEC 62.5 µg, UMEC/VI 62.5/25 µg; (6) UMEC/VI 62.5/25 µg, VI 25 µg, UMEC 62.5 µg. The three treatment periods were separated by a washout period of 10 to 14 days.
158613|NCT01716520|P6|Participant Flow|Sequence 6: UMEC/VI 62.5/25 µg, VI 25 µg, UMEC 62.5 µg|Participants received UMEC/VI 62.5/25 µg, VI 25 µg, and UMEC 62.5 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
158614|NCT01716520|P5|Participant Flow|Sequence 5: VI 25 µg, UMEC 62.5 µg, UMEC/VI 62.5/25 µg|Participants received VI 25 µg, UMEC 62.5 µg, and UMEC/VI 62.5/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
158615|NCT01716520|P4|Participant Flow|Sequence 4: UMEC 62.5 µg, UMEC/VI 62.5/25 µg, VI 25 µg|Participants received UMEC 62.5 µg, UMEC/VI 62.5/25 µg, and VI 25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
158617|NCT01716520|P2|Participant Flow|Sequence 2: VI 25 µg, UMEC/VI 62.5/25 µg, UMEC 62.5 µg|Participants received VI 25 µg, UMEC/VI 62.5/25 µg, and UMEC 62.5 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
158618|NCT01716520|P1|Participant Flow|Sequence 1: UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg|Participants received umeclidinium (UMEC) 62.5 micrograms (µg), vilanterol (VI) 25 µg, and UMEC/VI 62.5/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day (QD) for 14 days from a Dry Powder Inhaler (DPI). The three treatment periods were separated by a washout period of 10 to 14 days.
158619|NCT01716520|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
158620|NCT01716520|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
158621|NCT01716520|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
158622|NCT01716520|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
158623|NCT01716520|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
158624|NCT01716520|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
158625|NCT01716520|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
158626|NCT01716520|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
158627|NCT01716520|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
158628|NCT01716520|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
158629|NCT01716520|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
158630|NCT01716520|E3|Reported Event|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
158631|NCT01716520|E2|Reported Event|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
158632|NCT01716520|E1|Reported Event|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
158633|NCT01716468|B1|Baseline|Advanced or Metastatic Cancer|Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).
158634|NCT01716468|P1|Participant Flow|Advanced or Metastatic Cancer|Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).
158635|NCT01716468|O1|Outcome|Advanced or Metastatic Cancer|Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).
158636|NCT01716468|E1|Reported Event|Advanced or Metastatic Cancer|Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).
158637|NCT01716455|B7|Baseline|Total|Total of all reporting groups
158638|NCT01716455|B6|Baseline|SSP-004184 (Healthy Elderly Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
158639|NCT01716455|B5|Baseline|SSP-004184 (Matched Healthy Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
158640|NCT01716455|B4|Baseline|SSP-004184 (End Stage Renal Disease)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
158641|NCT01716455|B3|Baseline|SSP-004184 (Severe Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
158642|NCT01716455|B2|Baseline|SSP-004184 (Moderate Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
158643|NCT01716455|B1|Baseline|SSP-004184 (Mild Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
158644|NCT01716455|P6|Participant Flow|SSP-004184 (Healthy Elderly Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
158645|NCT01716455|P5|Participant Flow|SSP-004184 (Matched Healthy Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
158646|NCT01716455|P4|Participant Flow|SSP-004184 (End Stage Renal Disease)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
158647|NCT01716455|P3|Participant Flow|SSP-004184 (Severe Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
158648|NCT01716455|P2|Participant Flow|SSP-004184 (Moderate Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
173048|NCT01665170|O1|Outcome|Placebo|Placebo arm
158653|NCT01716455|O3|Outcome|SSP-004184 (Severe Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
158654|NCT01716455|O2|Outcome|SSP-004184 (Moderate Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
158655|NCT01716455|O1|Outcome|SSP-004184 (Mild Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
158656|NCT01716455|O6|Outcome|SSP-004184 (Healthy Elderly Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
158657|NCT01716455|O5|Outcome|SSP-004184 (Matched Healthy Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
158658|NCT01716455|O4|Outcome|SSP-004184 (End Stage Renal Disease)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
158659|NCT01716455|O3|Outcome|SSP-004184 (Severe Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
158660|NCT01716455|O2|Outcome|SSP-004184 (Moderate Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
158661|NCT01716455|O1|Outcome|SSP-004184 (Mild Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
158662|NCT01716455|E3|Reported Event|Healthy Elderly Subjects|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
158663|NCT01716455|E2|Reported Event|Matched Healthy Subjects|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
158664|NCT01716455|E1|Reported Event|Impaired Renal Function|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
158665|NCT01716234|B8|Baseline|Total|Total of all reporting groups
158666|NCT01716234|B7|Baseline|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
158667|NCT01716234|B6|Baseline|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
158668|NCT01716234|B5|Baseline|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
158669|NCT01716234|B4|Baseline|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158670|NCT01716234|B3|Baseline|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158671|NCT01716234|B2|Baseline|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158672|NCT01716234|B1|Baseline|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158673|NCT01716234|P7|Participant Flow|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
158674|NCT01716234|P6|Participant Flow|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
158675|NCT01716234|P5|Participant Flow|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
158676|NCT01716234|P4|Participant Flow|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158677|NCT01716234|P3|Participant Flow|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158678|NCT01716234|P2|Participant Flow|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158679|NCT01716234|P1|Participant Flow|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158680|NCT01716234|O7|Outcome|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
158681|NCT01716234|O6|Outcome|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
158682|NCT01716234|O5|Outcome|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
158683|NCT01716234|O4|Outcome|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158684|NCT01716234|O3|Outcome|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158685|NCT01716234|O2|Outcome|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158686|NCT01716234|O1|Outcome|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158687|NCT01716234|O7|Outcome|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
158688|NCT01716234|O6|Outcome|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
158729|NCT01716221|O3|Outcome|OFF - Bupropion Placebo + Citalopram Placebo (Week 10)|
158730|NCT01716221|O2|Outcome|Citalopram (Week 5)|
158689|NCT01716234|O5|Outcome|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
158690|NCT01716234|O4|Outcome|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158691|NCT01716234|O3|Outcome|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158692|NCT01716234|O2|Outcome|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158693|NCT01716234|O1|Outcome|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158694|NCT01716234|O7|Outcome|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
158695|NCT01716234|O6|Outcome|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
158696|NCT01716234|O5|Outcome|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
158697|NCT01716234|O4|Outcome|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158698|NCT01716234|O3|Outcome|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158699|NCT01716234|O2|Outcome|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158700|NCT01716234|O1|Outcome|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158701|NCT01716234|O7|Outcome|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
158702|NCT01716234|O6|Outcome|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
158703|NCT01716234|O5|Outcome|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
158704|NCT01716234|O4|Outcome|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158705|NCT01716234|O3|Outcome|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158706|NCT01716234|O2|Outcome|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158707|NCT01716234|O1|Outcome|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158708|NCT01716234|E7|Reported Event|POS 12 TID 3 Months to <2 Yrs|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
158709|NCT01716234|E6|Reported Event|POS 18 TID 7 to <18 Yrs|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
158710|NCT01716234|E5|Reported Event|POS 18 TID 2 to <7 Yrs|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
158711|NCT01716234|E4|Reported Event|POS 18 BID 7 to <18 Yrs|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158712|NCT01716234|E3|Reported Event|POS 18 BID 2 to <7 Yrs|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158713|NCT01716234|E2|Reported Event|POS 12 BID 7 to <18 Yrs|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158714|NCT01716234|E1|Reported Event|POS 12 BID 2 to <7 Yrs|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
158715|NCT01716221|B1|Baseline|Study Participant|the participant received all intervention combinations in the following order: bupropion & Citalopram, then Bupropion & Placebo, then Placebo & Citalopram, then Placebo & Placebo
158716|NCT01716221|P1|Participant Flow|Study Participant|the participant received all intervention combinations in the following order: bupropion & Citalopram, then Bupropion & Placebo, then Placebo & Citalopram, then Placebo & Placebo
158717|NCT01716221|O5|Outcome|Bupropion + Citalopram (Week 20)|
158718|NCT01716221|O4|Outcome|Bupropion Only (Week 15)|
158719|NCT01716221|O3|Outcome|OFF - Bupropion Placebo + Citalopram Placebo (Week 10)|
158720|NCT01716221|O2|Outcome|Citalopram (Week 5)|
158721|NCT01716221|O1|Outcome|Baseline - Unblinded on Buproprion and Citalopram|
158722|NCT01716221|O5|Outcome|Bupropion + Citalopram (Week 20)|
158723|NCT01716221|O4|Outcome|Bupropion Only (Week 15)|
158724|NCT01716221|O3|Outcome|OFF - Bupropion Placebo + Citalopram Placebo (Week 10)|
158725|NCT01716221|O2|Outcome|Citalopram (Week 5)|
158726|NCT01716221|O1|Outcome|Baseline - Unblinded on Buproprion and Citalopram|
158727|NCT01716221|O5|Outcome|Bupropion + Citalopram (Week 20)|
158728|NCT01716221|O4|Outcome|Bupropion Only (Week 15)|
158733|NCT01716221|O4|Outcome|Placebo & Placebo|"Placebo & Placebo taken orally one time per day~Placebo & Placebo"
158734|NCT01716221|O3|Outcome|Placebo & Citalopram|"Placebo & 20mg Citalopram taken orally one time per day or Placebo & 10mg Citalopram taken orally one time per day~Placebo & Citalopram"
158735|NCT01716221|O2|Outcome|Bupropion & Placebo|"100mg Bupropion & Placebo taken orally one time per day or 50mg Bupropion & Placebo taken orally one time per day~Bupropion & Placebo"
158736|NCT01716221|O1|Outcome|Bupropion & Citalopram|"100mg Bupropion & 20mg Citalopram taken orally one time per day or 100mg Bupropion & 10mg Citalopram taken orally one time per day or 50mg Bupropion & 20mg Citalopram taken orally one time per day or 50mg Bupropion & 10mg Citalopram taken orally one time per day~bupropion & Citalopram"
158737|NCT01716221|E4|Reported Event|Placebo & Placebo|"Placebo & Placebo taken orally one time per day~Placebo & Placebo"
158738|NCT01716221|E3|Reported Event|Placebo & Citalopram|"Placebo & 20mg Citalopram taken orally one time per day or Placebo & 10mg Citalopram taken orally one time per day~Placebo & Citalopram"
158739|NCT01716221|E2|Reported Event|Bupropion & Placebo|"100mg Bupropion & Placebo taken orally one time per day or 50mg Bupropion & Placebo taken orally one time per day~Bupropion & Placebo"
158740|NCT01716221|E1|Reported Event|Bupropion & Citalopram|"100mg Bupropion & 20mg Citalopram taken orally one time per day or 100mg Bupropion & 10mg Citalopram taken orally one time per day or 50mg Bupropion & 20mg Citalopram taken orally one time per day 0r 50mg Bupropion & 10mg Citalopram taken orally one time per day~bupropion & Citalopram"
158741|NCT01716169|B1|Baseline|Helicoll - Chronic Wound|"Helicoll will be applied to one chronic wound (approximately 6 months or more duration)~Helicoll: Helicoll Collagen I Wound Dressing"
158742|NCT01716169|P1|Participant Flow|Helicoll - Chronic Wound|"Helicoll will be applied to one chronic wound (approximately 6 months or more duration)~Helicoll: Helicoll Collagen I Wound Dressing"
158743|NCT01716169|O2|Outcome|Standard of Care Dressing - Chronic Wound|Standard of Care dressings will be applied to one chronic wound
158744|NCT01716169|O1|Outcome|Helicoll - Chronic Wound|"Helicoll will be applied to one chronic wound (approximately 6 months or more duration)~Helicoll: Helicoll Collagen I Wound Dressing"
158745|NCT01716169|E2|Reported Event|Standard of Care - Chronic Wound|Standard of Care wound dressings (e.g. Vaseline gauze) will be applied to one chronic wound (of approximately 6 months duration) if the subject has more than one chronic wound of approximately the same size and duration as Helicoll chronic wound.
158746|NCT01716169|E1|Reported Event|Helicoll - Chronic Wound|"Helicoll will be applied to one chronic wound (approximately 6 months or more duration)~Helicoll: Helicoll Collagen I Wound Dressing"
158747|NCT01716156|B4|Baseline|Total|Total of all reporting groups
158748|NCT01716156|B3|Baseline|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
158749|NCT01716156|B2|Baseline|Grazoprevir 100 mg + RBV 12 Weeks Plus Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
158750|NCT01716156|B1|Baseline|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
158751|NCT01716156|P3|Participant Flow|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
158752|NCT01716156|P2|Participant Flow|Grazoprevir 100 mg + RBV 12 Weeks Plus Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
158753|NCT01716156|P1|Participant Flow|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
158754|NCT01716156|O3|Outcome|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
158755|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV 12 Weeks Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
158756|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
158757|NCT01716156|O3|Outcome|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
158758|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV 12 Weeks Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
158759|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
158956|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158760|NCT01716156|O3|Outcome|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
158761|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV 12 Weeks Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
158762|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
158763|NCT01716156|O3|Outcome|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
158764|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV 12 Weeks Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
158765|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
158766|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV HCV GT1non-a|This group consisted of all participants with HCV GT1non-a infection, pooled across treatment arms.
158767|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV HCV GT1a|This group consisted of all participants with HCV GT1a infection pooled across treatment arms.
158768|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV: Beyond 12 Weeks|The beyond 12 weeks group consists of participants in the APaT population who received 24 total weeks of treatment, regardless of original treatment regimen assignment.
158769|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV: up to 12 Weeks|The up to 12 weeks group consists of participants in the APaT population who only received 12 weeks of treatment and not those originally assigned to 12 weeks that went on to receive 24 total weeks of treatment.
158770|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV: Beyond 12 Weeks|The beyond 12 weeks group consists of participants in the APaT population who received 24 total weeks of treatment, regardless of original treatment regimen assignment.
158771|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV: up to 12 Weeks|The up to 12 weeks group consists of participants in the APaT population who only received 12 weeks of treatment and not those originally assigned to 12 weeks that went on to receive 24 total weeks of treatment.
158772|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
158773|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
158774|NCT01716156|E2|Reported Event|Grazoprevir 100 mg + RBV: up to 12 Weeks|The up to 12 weeks group consists of participants in the APaT population who only received 12 weeks of treatment and not those originally assigned to 12 weeks that went on to receive 24 total weeks of treatment.
158775|NCT01716156|E1|Reported Event|Grazoprevir 100 mg + RBV: Beyond 12 Weeks|The beyond 12 weeks group consists of participants in the APaT population who received 24 total weeks of treatment, regardless of original treatment regimen assignment.
158776|NCT01716052|B3|Baseline|Total|Total of all reporting groups
158777|NCT01716052|B2|Baseline|Placebo|"Lactulose~placebo: Lactulose"
158778|NCT01716052|B1|Baseline|Ibuprofen|"Pfizer 200 mg caplets (Advil)~Ibuprofen"
158779|NCT01716052|P2|Participant Flow|Placebo|"Lactulose~placebo: Lactulose"
158780|NCT01716052|P1|Participant Flow|Ibuprofen|"Pfizer 200 mg caplets (Advil)~Ibuprofen"
158781|NCT01716052|O2|Outcome|Placebo|"Lactulose~placebo: Lactulose"
158782|NCT01716052|O1|Outcome|Ibuprofen|"Pfizer 200 mg caplets (Advil)~Ibuprofen"
158783|NCT01716052|E2|Reported Event|Placebo|"Lactulose~placebo: Lactulose"
158784|NCT01716052|E1|Reported Event|Ibuprofen|"Pfizer 200 mg caplets (Advil)~Ibuprofen"
158785|NCT01716013|B3|Baseline|Total|Total of all reporting groups
158786|NCT01716013|B2|Baseline|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips~CWCD: traditional closure methods of sutures, staples or adhesive strips"
158787|NCT01716013|B1|Baseline|BondEase|"Topical Skin Adhesive~BondEase: topical skin adhesive"
158788|NCT01716013|P2|Participant Flow|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips~CWCD: traditional closure methods of sutures, staples or adhesive strips"
158789|NCT01716013|P1|Participant Flow|BondEase|"Topical Skin Adhesive~BondEase: topical skin adhesive"
158790|NCT01716013|O2|Outcome|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips~CWCD: traditional closure methods of sutures, staples or adhesive strips"
158791|NCT01716013|O1|Outcome|BondEase|"Topical Skin Adhesive~BondEase: topical skin adhesive"
158792|NCT01716013|O2|Outcome|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips~CWCD: traditional closure methods of sutures, staples or adhesive strips"
158793|NCT01716013|O1|Outcome|BondEase|"Topical Skin Adhesive~BondEase: topical skin adhesive"
158794|NCT01716013|O2|Outcome|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips~CWCD: traditional closure methods of sutures, staples or adhesive strips"
158795|NCT01716013|O1|Outcome|BondEase|"Topical Skin Adhesive~BondEase: topical skin adhesive"
158796|NCT01716013|O2|Outcome|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips~CWCD: traditional closure methods of sutures, staples or adhesive strips"
158798|NCT01716013|E2|Reported Event|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips~CWCD: traditional closure methods of sutures, staples or adhesive strips"
158799|NCT01716013|E1|Reported Event|BondEase|"Topical Skin Adhesive~BondEase: topical skin adhesive"
158800|NCT01715948|B1|Baseline|A Comparison Between Wireless CROS and BAHD for SSD|"Participants who have been implanted with a BAHD over the past three years will be given a two-week trial period with a CROS hearing aid. The CROS uses two hearing aids that fit behind each ear. The hearing aid fitted on the side of the poor ear houses a microphone and a transmitter. The hearing aid fitted on the normal ear side houses a receiver that is connected to an open ear tip. Sounds on the side of the poor ear are picked up by the microphone and transmitted to the opposite normal ear, overcoming the head shadow effect that presents with unilateral deafness.~CROS hearing aid: BAHD users will be fitted with the CROS hearing aid for a two-week trial period. Their hearing abilities with the CROS hearing aid will be compared to their hearing abilities with their BAHD over a two-week period."
158801|NCT01715948|P1|Participant Flow|Contralateral Routing of Signals (CROS) Hearing Aid|"Participants who have been implanted with a bone-anchored hearing device (BAHD) over the past three years will be given a two-week trial period with a Contralateral Routing of Signals (CROS) hearing aid. The CROS uses two hearing aids that fit behind each ear. The hearing aid fitted on the side of the poor ear houses a microphone and a transmitter. The hearing aid fitted on the normal ear side houses a receiver that is connected to an open ear tip. Sounds on the side of the poor ear are picked up by the microphone and transmitted to the opposite normal ear, overcoming the head shadow effect that presents with unilateral deafness.~Both devices were compared on head shadow effect reduction, speech perception measures in quiet and in noise, self-assessment questionnaires, and daily diaries."
158802|NCT01715948|O6|Outcome|SSQ Subscale - Qualities (CROS)|Participants rated the effectiveness of the CROS for listening situations included in the Qualities subscale of the SSQ on a 10-point scale.
158803|NCT01715948|O5|Outcome|SSQ Subscale - Qualities (BAHD)|Participants rated the effectiveness of the BAHD for listening situations included in the Qualities subscale of the SSQ on a 10-point scale.
158804|NCT01715948|O4|Outcome|SSQ Subscale - Spatial (CROS)|Participants rated the effectiveness of the CROS for listening situations included in the Spatial subscale of the SSQ on a 10-point scale.
158805|NCT01715948|O3|Outcome|SSQ Subscale - Spatial (BAHD)|Participants rated the effectiveness of the BAHD for listening situations included in the Spatial subscale of the SSQ on a 10-point scale.
158806|NCT01715948|O2|Outcome|SSQ Subscale - Speech (CROS)|Participants rated the effectiveness of the CROS for listening situations included in the Speech subscale of the SSQ on a 10-point scale.
158807|NCT01715948|O1|Outcome|SSQ Subscale - Speech (BAHD)|Participants rated the effectiveness of the BAHD for listening situations included in the Speech subscale of the SSQ on a 10-point scale.
158808|NCT01715948|O3|Outcome|WRS in Quiet to Poorer Ear|Word recognition was tested with no noise (quiet) with words presented at 90 degrees azimuth to the poorer ear. This occurred across three randomized listening conditions: unaided, BAHD and CROS.
158809|NCT01715948|O2|Outcome|WRS Noise to Poorer Ear|Word recognition was tested with words presented from the front and multitalker noise (at 45 dB HL) at 90 degrees azimuth to the poorer ear. This occurred across three randomized listening conditions: unaided, BAHD and CROS.
158810|NCT01715948|O1|Outcome|WRS Noise to Better Ear|Word recognition was tested with words presented from the front and multitalker noise (at 45 dB HL) at 90 degrees azimuth to the better ear. This occurred across three randomized listening conditions: unaided, BAHD and CROS.
158811|NCT01715948|O6|Outcome|QuickSIN Noise to Poorer Ear With CROS|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing the CROS.
158812|NCT01715948|O5|Outcome|QuickSIN Noise to Poorer Ear With BAHD|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing the BAHD.
158813|NCT01715948|O4|Outcome|QuickSIN Noise to Poorer Ear Unaided|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing no device.
158814|NCT01715948|O3|Outcome|QuickSIN Noise to Better Ear With CROS|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing the CROS.
158815|NCT01715948|O2|Outcome|QuickSIN Noise to Better Ear With BAHD|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing the BAHD.
158816|NCT01715948|O1|Outcome|QuickSIN Noise to Better Ear Unaided|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing no device. The multitalker noise increases with each sentence presentation such that the signal-to-noise ratio decreases from 25 to 0 dB, in 5-dB steps, over the six sentences.
158817|NCT01715948|E2|Reported Event|CROS Aid|The intervention during which the CROS aid was trialed as part of the cross-over design
158818|NCT01715948|E1|Reported Event|BAHD|The intervention during which the BAHD was trialed as part of the cross-over design
158819|NCT01715896|B3|Baseline|Total|Total of all reporting groups
158820|NCT01715896|B2|Baseline|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158821|NCT01715896|B1|Baseline|Golimumab 50 Milligram (mg) Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158822|NCT01715896|P2|Participant Flow|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158823|NCT01715896|P1|Participant Flow|Golimumab 50 Milligram (mg) Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158824|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158825|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158826|NCT01715896|O1|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158827|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158828|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158829|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158830|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158831|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158832|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158833|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158834|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158835|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158836|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158837|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158838|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158839|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158840|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158841|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158842|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158843|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158844|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158845|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158846|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158847|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158848|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158849|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158850|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158851|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158852|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158853|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158854|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158855|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158856|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158857|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158858|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158859|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158860|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158861|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158862|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158863|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158864|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158865|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158866|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158867|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158868|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158869|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158870|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158871|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158872|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158873|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158874|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158875|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158876|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158877|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158878|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158879|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158880|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158881|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158882|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158883|NCT01715896|E2|Reported Event|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158884|NCT01715896|E1|Reported Event|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
158885|NCT01715857|B1|Baseline|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
158886|NCT01715857|P1|Participant Flow|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
158887|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
158888|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
158889|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
158890|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
158891|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
158892|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
159002|NCT01714817|B3|Baseline|Total|Total of all reporting groups
158893|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
158894|NCT01715857|E1|Reported Event|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
158895|NCT01715831|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
158896|NCT01715831|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received disease-modifying anti-rheumatic drugs (DMARDs) in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
158897|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
158898|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
158899|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
158900|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
158901|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
158902|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
158903|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
158904|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
158905|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
158906|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
158907|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
158908|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
158909|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
158910|NCT01715831|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
158913|NCT01715415|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
158914|NCT01715415|P2|Participant Flow|Placebo Followed by ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
158915|NCT01715415|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
158916|NCT01715415|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
158917|NCT01715415|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
158918|NCT01715415|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
158919|NCT01715415|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
158920|NCT01715415|O2|Outcome|Placebo|Double-blind placebo for 12 weeks
158921|NCT01715415|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
158922|NCT01715415|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
158923|NCT01715415|E3|Reported Event|Open Label ABT-450/r/ABT-267 and ABT-333, Plus RBV|Open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
158924|NCT01715415|E2|Reported Event|Double Blind Placebo|Double-blind placebo for 12 weeks
158925|NCT01715415|E1|Reported Event|Double Blind ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
158926|NCT01715298|B3|Baseline|Total|Total of all reporting groups
158927|NCT01715298|B2|Baseline|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158928|NCT01715298|B1|Baseline|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158929|NCT01715298|P2|Participant Flow|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158930|NCT01715298|P1|Participant Flow|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158931|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158932|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158933|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158934|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158935|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158936|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158937|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158938|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158939|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158940|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158941|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158942|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158943|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158944|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158945|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158946|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158947|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158948|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158949|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158950|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158951|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158952|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158953|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158954|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158955|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158957|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158958|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158959|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158960|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158961|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158962|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158963|NCT01715298|E2|Reported Event|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158964|NCT01715298|E1|Reported Event|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
158965|NCT01715207|B3|Baseline|Total|Total of all reporting groups
158966|NCT01715207|B2|Baseline|Atenolol|"Atenolol tablet(Negative controls, Open-label)~Atenolol"
158967|NCT01715207|B1|Baseline|Atenolol & Aliskiren|"Atenolol tablet and Aliskiren 150mg or 300mg tablet by mouth per day for 6month~Aliskiren~Atenolol"
158968|NCT01715207|P2|Participant Flow|Atenolol|"Atenolol tablet(Negative controls, Open-label)~Atenolol"
158969|NCT01715207|P1|Participant Flow|Atenolol & Aliskiren|"Atenolol tablet and Aliskiren 150mg or 300mg tablet by mouth per day for 6month~Aliskiren~Atenolol"
158970|NCT01715207|O2|Outcome|Atenolol|"Atenolol tablet(Negative controls, Open-label)~Control group baseline 24 Weeks Central PWV (m/s)(26) by MRI regional PWV A (level 1-2) 3.8 (1.7) 3.6 (1.23) PWV-total (level 1-4) 5.0 (1.03) 4.9 (1.24)"
158971|NCT01715207|O1|Outcome|Atenolol and Aliskiren|Aliskiren (Norvatis) 300mg oral tablet
158972|NCT01715207|O2|Outcome|Atenolol|"Atenolol tablet(Negative controls, Open-label)~Atenolol"
158973|NCT01715207|O1|Outcome|Atenolol & Aliskiren|"Atenolol tablet and Aliskiren 150mg or 300mg tablet by mouth per day for 6month~Aliskiren~Atenolol"
158974|NCT01715207|E2|Reported Event|Atenolol|"Atenolol tablet(Negative controls, Open-label)~Control (n=14) Overall rate of adverse events 10 (71.4%) moderate to severe cases 2 (14.3%) generalized symptoms 4 (28.6%) gastrointestinal symptoms 3 (21.4%) lung problems 1 (7.1%) cardiovascular symptoms 0 central nervous system symptoms 1 (7.1%) Eye, nose, throat symptoms 1 (7.1%) gynecologic problems 1 (7.1%) problems of extremities 2 (14.3%)"
158975|NCT01715207|E1|Reported Event|Atenolol & Aliskiren|"Atenolol tablet and Aliskiren 150mg or 300mg tablet by mouth per day for 6month~Treatment (n=14) Overall rate of adverse events 12 (85.7%) moderate to severe cases 0 generalized symptoms 8 (57.1%) gastrointestinal symptoms 4 (28.6%) lung problems 0 cardiovascular symptoms 3 (21.4%) central nervous system symptoms 5 (35.7%) Eye, nose, throat symptoms 4 (28.6%) gynecologic problems 1 (7.1%) problems of extremities 1 (7.1%)"
158976|NCT01715129|B1|Baseline|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
158977|NCT01715129|P1|Participant Flow|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
158978|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
158979|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
158980|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
158981|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
158982|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
158983|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
158984|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
158985|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
158986|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
158987|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
158988|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
158989|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
158990|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
158991|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
158992|NCT01715129|E1|Reported Event|Triptorelin Pamoate 11.25 mg|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
158993|NCT01715064|B3|Baseline|Total|Total of all reporting groups
158994|NCT01715064|B2|Baseline|Exercise|1 hour of moderate intensity exercise.
158995|NCT01715064|B1|Baseline|Control|non-exercise control consisting of movie watching.
158996|NCT01715064|P2|Participant Flow|Exercise (1hr of Mixed-modality Exercise)|1 hour of moderate intensity exercise. The session included 5- min warm-up, 25-min of resistance training, 25-min of aerobic training, and 5-min cool-down. Each session was led by a personal trainer and supervised by an exercise physiologist.
158997|NCT01715064|P1|Participant Flow|Control (1hr of Viewing Emotionally Neutral Movie)|non-exercise control consisting of movie watching for 60 mins. the videos were short cartoon films considered to be emotionally neutral.
158998|NCT01715064|O2|Outcome|Exercise|1 hour of moderate intensity exercise.
158999|NCT01715064|O1|Outcome|Control|non-exercise control consisting of movie watching.
159000|NCT01715064|E2|Reported Event|Exercise|1 hour of moderate intensity exercise.
159001|NCT01715064|E1|Reported Event|Control|non-exercise control consisting of movie watching.
159003|NCT01714817|B2|Baseline|Placebo IV|Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks
159004|NCT01714817|B1|Baseline|Abatacept IV|Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks
159005|NCT01714817|P2|Participant Flow|Placebo IV|Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks
159006|NCT01714817|P1|Participant Flow|Abatacept IV|Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks
159007|NCT01714817|O1|Outcome|All Treated|all nephrotic and non-nephrotic participants who received at least 1 Abatacept Infusion and have at least 1 Cmin value during year 1 of the double-blind period
159008|NCT01714817|O1|Outcome|All Treated|all nephrotic and non-nephrotic participants who received at least 1 Abatacept Infusion and have at least 1 Cmin value during year 1 of the double-blind period
159009|NCT01714817|O1|Outcome|All Treated|all nephrotic and non-nephrotic participants who received at least 1 Abatacept Infusion and have at least 1 Cmin value during year 1 of the double-blind period
159010|NCT01714817|O2|Outcome|Placebo IV|Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks
159011|NCT01714817|O1|Outcome|Abatacept IV|Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks
159012|NCT01714817|O2|Outcome|Placebo IV|Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks
159013|NCT01714817|O1|Outcome|Abatacept IV|Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks
159014|NCT01714817|O2|Outcome|Placebo IV|Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks
159015|NCT01714817|O1|Outcome|Abatacept IV|Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks
159016|NCT01714817|O2|Outcome|Placebo IV|Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks
159017|NCT01714817|O1|Outcome|Abatacept IV|Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks
159018|NCT01714817|O2|Outcome|Placebo IV|Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks
159019|NCT01714817|O1|Outcome|Abatacept IV|Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks
159020|NCT01714817|O2|Outcome|Placebo IV|Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks
159021|NCT01714817|O1|Outcome|Abatacept IV|Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks
159022|NCT01714817|E2|Reported Event|Placebo IV|Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks
159023|NCT01714817|E1|Reported Event|Abatacept IV|Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks
159024|NCT01714804|B3|Baseline|Total|Total of all reporting groups
159025|NCT01714804|B2|Baseline|Retrospective|"Infuse~rh-BMP2 retrospective study arm"
159026|NCT01714804|B1|Baseline|Prospective|"Accell Evo3~Accell Evo3 prospective study arm"
159027|NCT01714804|P2|Participant Flow|Infuse|Retrospective patients who were treated with posterolateral fusion at one to three levels between L3 and S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Infuse (rh-BMP2) was used with autogenous cancellous bone in the posterolateral space. Subjects in this treatment arm were historical controls and were not enrolled in this study.
159028|NCT01714804|P1|Participant Flow|Accell Evo3|Prospectively enrolled patients who required posterolateral fusion at one to three levels between L3 and S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Accell Evo3 was used with autogenous cancellous bone in the posterolateral space.
159114|NCT01714310|P3|Participant Flow|Open Lisdexamfetamine|All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing to the end of study week 4.
159247|NCT01713621|E2|Reported Event|OZ439 500mg|Single dose of 500mg of OZ439 administered as an oral suspension
159029|NCT01714804|O2|Outcome|Infuse|Retrospective patients who were treated with posterolateral fusion at one to three levels between L3 and S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Infuse (rh-BMP2) was used with autogenous cancellous bone in the posterolateral space. Subjects in this treatment arm were historical controls and were not enrolled in this study.
159030|NCT01714804|O1|Outcome|Accell Evo3|Prospectively enrolled patients who required posterolateral fusion at one to three levels between L3 and S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Accell Evo3 was used with autogenous cancellous bone in the posterolateral space.
159031|NCT01714804|O2|Outcome|Infuse|Retrospective patients who were treated with posterolateral fusion at one to three levels between L3 to S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Infuse (rh-BMP2) was used with autogenous cancellous bone in the posterolateral space.
159032|NCT01714804|O1|Outcome|Accell Evo3|Prospectively enrolled patients who required posterolateral fusion at one to three levels between L3 to S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Accell Evo3 was used with autogenous cancellous bone in the posterolateral space.
159033|NCT01714804|E2|Reported Event|Infuse|Retrospective patients who were treated with posterolateral fusion at one to three levels between L3 and S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Infuse (rh-BMP2) was used with autogenous cancellous bone in the posterolateral space.
159034|NCT01714804|E1|Reported Event|Accell Evo3|Prospectively enrolled patients who required posterolateral fusion at one to three levels between L3 and S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Accell Evo3 was used with autogenous cancellous bone in the posterolateral space.
159035|NCT01714635|B4|Baseline|Total|Total of all reporting groups
159036|NCT01714635|B3|Baseline|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)~Monofocal Intraocular Lens"
159037|NCT01714635|B2|Baseline|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
159038|NCT01714635|B1|Baseline|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
159039|NCT01714635|P3|Participant Flow|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)~Monofocal Intraocular Lens"
159040|NCT01714635|P2|Participant Flow|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
159041|NCT01714635|P1|Participant Flow|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
159042|NCT01714635|O3|Outcome|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)~Monofocal Intraocular Lens"
159043|NCT01714635|O2|Outcome|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
159044|NCT01714635|O1|Outcome|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
159045|NCT01714635|O3|Outcome|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)~Monofocal Intraocular Lens"
159046|NCT01714635|O2|Outcome|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
159047|NCT01714635|O1|Outcome|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
159048|NCT01714635|O3|Outcome|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)~Monofocal Intraocular Lens"
159049|NCT01714635|O2|Outcome|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
159050|NCT01714635|O1|Outcome|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
159051|NCT01714635|E3|Reported Event|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)~Monofocal Intraocular Lens"
159052|NCT01714635|E2|Reported Event|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
159053|NCT01714635|E1|Reported Event|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
159054|NCT01714609|B3|Baseline|Total|Total of all reporting groups
159055|NCT01714609|B2|Baseline|Sorafenib|"Subjects randomized to Sorafenib will take Sorafenib 400 mg by mouth twice daily.~Sorafenib: Sorafenib, 400 mg twice daily"
159056|NCT01714609|B1|Baseline|Placebo|"Subjects randomized to placebo will take two tablets of placebo by mouth twice daily.~Placebo: Placebo Comparator: Placebo"
159057|NCT01714609|P2|Participant Flow|Sorafenib|"Subjects randomized to Sorafenib will take Sorafenib 400 mg by mouth twice daily.~Sorafenib: Sorafenib, 400 mg twice daily"
159058|NCT01714609|P1|Participant Flow|Placebo|"Subjects randomized to placebo will take two tablets of placebo by mouth twice daily.~Placebo: Placebo Comparator: Placebo"
159059|NCT01714609|O2|Outcome|Sorafenib|"Subjects randomized to Sorafenib will take Sorafenib 400 mg by mouth twice daily.~Sorafenib: Sorafenib, 400 mg twice daily"
159060|NCT01714609|O1|Outcome|Placebo|"Subjects randomized to placebo will take two tablets of placebo by mouth twice daily.~Placebo: Placebo Comparator: Placebo"
159061|NCT01714609|E2|Reported Event|Sorafenib|"Subjects randomized to Sorafenib will take Sorafenib 400 mg by mouth twice daily.~Sorafenib: Sorafenib, 400 mg twice daily"
159062|NCT01714609|E1|Reported Event|Placebo|"Subjects randomized to placebo will take two tablets of placebo by mouth twice daily.~Placebo: Placebo Comparator: Placebo"
159063|NCT01714544|B1|Baseline|Cloderm Cream|"Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days~Cloderm Cream"
159064|NCT01714544|P1|Participant Flow|Cloderm Cream|"Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days~Cloderm Cream"
159065|NCT01714544|O1|Outcome|Cloderm Cream|"Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days~Cloderm Cream"
159066|NCT01714544|E1|Reported Event|Cloderm Cream|"Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days~Cloderm Cream"
159067|NCT01714505|B1|Baseline|Open and Closed Loop Control|"Closed-Loop: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia.~Open-Loop: Insulin delivery will be controlled by the DiAs system running in open-loop mode. The subject will interact with the system through its GUI. Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings."
159068|NCT01714505|P2|Participant Flow|Closed-Loop Then Open-Loop Control|"Closed-Loop: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia.~Open-Loop: Insulin delivery will be controlled by the DiAs system running in open-loop mode. The subject will interact with the system through its GUI. Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings."
159069|NCT01714505|P1|Participant Flow|Open-Loop Then Closed-Loop Control|"Open-Loop: Insulin delivery will be controlled by the DiAs system running in open-loop mode. The subject will interact with the system through its GUI. Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings.~Closed-Loop: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia."
159070|NCT01714505|O2|Outcome|Open-Loop CGM-Augmented Insulin Pump Therapy|Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. The subject will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values.
159071|NCT01714505|O1|Outcome|Closed-loop Control to Range|"Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system.~Diabetes Assistant (DiAs): A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night."
159072|NCT01714505|O2|Outcome|Open-Loop CGM-Augmented Insulin Pump Therapy|Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. The subject will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values.
159073|NCT01714505|O1|Outcome|Closed-loop Control to Range|"Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system.~Diabetes Assistant (DiAs): A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night."
159074|NCT01714505|O2|Outcome|Open-Loop CGM-Augmented Insulin Pump Therapy|Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. The subject will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values.
159075|NCT01714505|O1|Outcome|Closed-loop Control to Range|"Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system.~Diabetes Assistant (DiAs): A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night."
159115|NCT01714310|P2|Participant Flow|Placebo|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at study week 4 and continuing through study week 12.
159076|NCT01714505|E2|Reported Event|Open-Loop CGM-Augmented Insulin Pump Therapy|Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. The subject will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values.
159077|NCT01714505|E1|Reported Event|Closed-loop Control to Range|"Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system.~Diabetes Assistant (DiAs): A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night."
159078|NCT01714492|B1|Baseline|Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
159079|NCT01714492|P1|Participant Flow|Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
159080|NCT01714492|O1|Outcome|In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
159081|NCT01714492|O1|Outcome|In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
159082|NCT01714492|O1|Outcome|In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
159083|NCT01714492|O1|Outcome|In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
159084|NCT01714492|O1|Outcome|Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
159085|NCT01714492|O1|Outcome|In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
159086|NCT01714492|E1|Reported Event|Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
159087|NCT01714336|B3|Baseline|Total|Total of all reporting groups
159088|NCT01714336|B2|Baseline|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
159089|NCT01714336|B1|Baseline|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
159090|NCT01714336|P2|Participant Flow|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
159091|NCT01714336|P1|Participant Flow|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% sodium chloride (NaCL) will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
159092|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
159093|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
159094|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
159095|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
159096|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
159097|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
159098|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
159099|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
159100|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
159101|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
159102|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
159103|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
159104|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
159105|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
159106|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
159107|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
159108|NCT01714336|E2|Reported Event|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
159109|NCT01714336|E1|Reported Event|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
159110|NCT01714310|B4|Baseline|Total|Total of all reporting groups
159111|NCT01714310|B3|Baseline|Placebo|Randomized participants who competed open-label lisdexamfetamine titration from baseline through week 3, who continued to meet eligibility criteria, and then proceeded to adjunctive placebo from week 4 through week 12.
159112|NCT01714310|B2|Baseline|Fluoxetine|Randomized participants who competed open-label lisdexamfetamine titration from baseline through week 3, who continued to meet eligibility criteria, and then proceeded to adjunctive fluoxetine therapy from week 4 through week 12.
159113|NCT01714310|B1|Baseline|Open Lisdexamfetamine|All eligible participants initially titrated to optimal dose open lisdexamfetamine from baseline through week 3.
159116|NCT01714310|P1|Participant Flow|Fluoxetine|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at study week 4 and continuing to study week 12.
159117|NCT01714310|O3|Outcome|Open Lisdexamfetamine|All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.
159118|NCT01714310|O2|Outcome|Placebo|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
159119|NCT01714310|O1|Outcome|Fluoxetine|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
159120|NCT01714310|O3|Outcome|Open Lisdexamfetamine|All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.
159121|NCT01714310|O2|Outcome|Placebo|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
159122|NCT01714310|O1|Outcome|Fluoxetine|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
159123|NCT01714310|O3|Outcome|Open Lisdexamfetamine|All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.
159124|NCT01714310|O2|Outcome|Placebo|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
159125|NCT01714310|O1|Outcome|Fluoxetine|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
159126|NCT01714310|O3|Outcome|Open Lisdexamfetamine|All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.
159127|NCT01714310|O2|Outcome|Placebo|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
159128|NCT01714310|O1|Outcome|Fluoxetine|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
159129|NCT01714310|O3|Outcome|Open Lisdexamfetamine|All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.
159130|NCT01714310|O2|Outcome|Placebo|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
159131|NCT01714310|O1|Outcome|Fluoxetine|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
159132|NCT01714310|O3|Outcome|Open Lisdexamfetamine|All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.
159133|NCT01714310|O2|Outcome|Placebo|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at study week 4 and continuing through study week 12.
159134|NCT01714310|O1|Outcome|Fluoxetine|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at study week 4 and continuing to study week 12.
159135|NCT01714310|O3|Outcome|Open Lisdexamfetamine|All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.
159136|NCT01714310|O2|Outcome|Placebo|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
159137|NCT01714310|O1|Outcome|Fluoxetine|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
159138|NCT01714310|O3|Outcome|Open Lisdexamfetamine|All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.
159139|NCT01714310|O2|Outcome|Placebo|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
159140|NCT01714310|O1|Outcome|Fluoxetine|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
159141|NCT01714310|O3|Outcome|Open Lisdexamfetamine|All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.
159142|NCT01714310|O2|Outcome|Placebo|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
159143|NCT01714310|O1|Outcome|Fluoxetine|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
159144|NCT01714310|O3|Outcome|Open Lisdexamfetamine|All eligible participants initially titrated to optimal dose open lisdexamfetamine at study visits 2-6.
159145|NCT01714310|O2|Outcome|Placebo|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 though week 12.
159146|NCT01714310|O1|Outcome|Fluoxetine|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
159147|NCT01714310|O3|Outcome|Open Lisdexamfetamine|All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through week 4.
159148|NCT01714310|O2|Outcome|Placebo|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
159149|NCT01714310|O1|Outcome|Fluoxetine|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
159150|NCT01714310|O3|Outcome|Open Lisdexamfetamine|All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.
173049|NCT01665170|O2|Outcome|Placebo|Placebo arm
159151|NCT01714310|O2|Outcome|Placebo|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 and continuing through week 12.
159152|NCT01714310|O1|Outcome|Fluoxetine|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing tp week 12.
159153|NCT01714310|O3|Outcome|Open Lisdexamfetamine|All eligible participants initially titrated to optimal dose open lisdexamfetamine at study visits 2-6.
159154|NCT01714310|O2|Outcome|Placebo|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at end of study week 4 and continuing through week.
159155|NCT01714310|O1|Outcome|Fluoxetine|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at end of study week 4 6 continuing through week 12.
159156|NCT01714310|O3|Outcome|Open Lisdexamfetamine|All eligible participants initially titrated to optimal dose open lisdexamfetamine starting at baseline (week 0) and continuing through study week.
159157|NCT01714310|O2|Outcome|Placebo|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.
159158|NCT01714310|O1|Outcome|Fluoxetine|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.
159159|NCT01714310|E3|Reported Event|Open Lisdexamfetamine|All eligible participants initially titrated to optimal dose open lisdexamfetamine from baseline through week 4.
159160|NCT01714310|E2|Reported Event|Placebo|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at study week 4 and continuing through week 12.
159161|NCT01714310|E1|Reported Event|Fluoxetine|All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 and continuing though week 12.
159162|NCT01714232|B1|Baseline|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
159163|NCT01714232|P1|Participant Flow|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
159164|NCT01714232|O1|Outcome|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
159165|NCT01714232|O1|Outcome|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
159166|NCT01714232|O1|Outcome|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
159167|NCT01714232|E1|Reported Event|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
159168|NCT01714024|B4|Baseline|Total|Total of all reporting groups
159169|NCT01714024|B3|Baseline|Osteopenic Subjects|"Subjects must be diagnosed with osteoporosis or osteopenia and must be currently under the care of a physician and treatment with oral bisphosphonates~Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.~Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
159170|NCT01714024|B2|Baseline|Diabetic Subjects|"Subjects must have Type 2 diabetes mellitus as diagnosed by a physician or in medication history. The condition must be currently diagnosed and treated by medications and/or insulin.~Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.~Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
159171|NCT01714024|B1|Baseline|Healthy Volunteers|"Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.~Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.~Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
159238|NCT01713660|O1|Outcome|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
159239|NCT01713660|E1|Reported Event|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
159240|NCT01713621|B3|Baseline|Total|Total of all reporting groups
159241|NCT01713621|B2|Baseline|OZ439 500mg|Single dose of 500mg of OZ439 administered as an oral suspension
173050|NCT01665170|O1|Outcome|Verum|Verum arm - Pascoflair 425mg
159172|NCT01714024|P3|Participant Flow|Osteopenic Subjects|"Subjects must be diagnosed with osteoporosis or osteopenia and must be currently under the care of a physician and treatment with oral bisphosphonates~Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.~Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
159173|NCT01714024|P2|Participant Flow|Diabetic Subjects|"Subjects must have Type 2 diabetes mellitus as diagnosed by a physician or in medication history. The condition must be currently diagnosed and treated by medications and/or insulin.~Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.~Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
159174|NCT01714024|P1|Participant Flow|Healthy Volunteers|"Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.~Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.~Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
159175|NCT01714024|O6|Outcome|Osteoporosis Titanium|"Subjects must be diagnosed with osteoporosis or osteopenia and must be currently under the care of a physician and treatment with oral bisphosphonates~Zimmer Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
159176|NCT01714024|O5|Outcome|Osteoporosis Tantalum|"Subjects must be diagnosed with osteoporosis or osteopenia and must be currently under the care of a physician and treatment with oral bisphosphonates~Zimmer Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
159177|NCT01714024|O4|Outcome|Diabetic Titanium|"Subjects must have Type 2 diabetes mellitus as diagnosed by a physician or in medication history. The condition must be currently diagnosed and treated by medications and/or insulin.~Zimmer Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
159178|NCT01714024|O3|Outcome|Diabetic Tantalum|"Subjects must have Type 2 diabetes mellitus as diagnosed by a physician or in medication history. The condition must be currently diagnosed and treated by medications and/or insulin.~Zimmer Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks"
159179|NCT01714024|O2|Outcome|Heathy Titanium|"Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.~Zimmer Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
159180|NCT01714024|O1|Outcome|Healthy Tantalum|"Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.~Zimmer Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
159181|NCT01714024|O6|Outcome|Diabetic/Titanium|"Subjects who are diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis~For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks."
159182|NCT01714024|O5|Outcome|Diabetic/Tantalum|"Subjects who are diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis~For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks."
159183|NCT01714024|O4|Outcome|Osteopenic/Titanium|"Subjects must be diagnosed with osteoporosis or osteopenia, non-diabetic, with no history of smoking within the past two years~For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks."
159184|NCT01714024|O3|Outcome|Osteopenic/Tantalum|"Subjects must be diagnosed with osteoporosis or osteopenia, non-diabetic, with no history of smoking within the past two years~For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks."
159185|NCT01714024|O2|Outcome|Healthy/Titanium|"Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.~For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks."
159186|NCT01714024|O1|Outcome|Healthy/Tantalum|"Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.~For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks."
159187|NCT01714024|E3|Reported Event|Osteopenic Subjects|"Subjects must be diagnosed with osteoporosis or osteopenia and must be currently under the care of a physician and treatment with oral bisphosphonates~Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.~Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
159188|NCT01714024|E2|Reported Event|Diabetic Subjects|"Subjects must have Type 2 diabetes mellitus as diagnosed by a physician or in medication history. The condition must be currently diagnosed and treated by medications and/or insulin.~Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.~Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
159189|NCT01714024|E1|Reported Event|Healthy Volunteers|"Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.~Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.~Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
159190|NCT01713998|B4|Baseline|Total|Total of all reporting groups
159191|NCT01713998|B3|Baseline|Group C|Subjects received Ultherapy® treatment using standard (highest) energy settings on both sides of the lower face and neck. On the upper face (brow), the 4-4.5mm transducer used at the second highest energy setting on one side of the upper face and the 7-4.5mm transducer at the standard (highest) energy setting on the contralateral side of the upper face.
159192|NCT01713998|B2|Baseline|Group B|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.
159193|NCT01713998|B1|Baseline|Group A|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.
159194|NCT01713998|P3|Participant Flow|Group C|Subjects received an increased density guideline treatment over the full face. The upper face treatment was provided in a split-face treatment using the 4 MHz transducer at no higher than the second highest energy setting on one side of the upper face and the 7 MHz transducer at the highest energy setting on other side of the upper face.
159195|NCT01713998|P2|Participant Flow|Group B|Subjects received an increased density guideline treatment over the full face but with the energy reduced to the lowest level of four possible energy settings on one side of the face.
159196|NCT01713998|P1|Participant Flow|Group A|Subjects received an increased density guideline treatment over the full face but with the energy reduced to the second highest level of four possible energy settings on one side of the face.
159197|NCT01713998|O3|Outcome|Group C|Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4-4.5mm transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7-4.5mm transducer at the (standard) highest energy setting on the contralateral side of the upper face. For Group C, the standard energy side is defined as the upper face side treated with the 7-4.5mm transducer at the highest energy setting and the corresponding lower face side; the adjusted energy side is defined as the upper face side treated with 4-4.5mm transducer at the second highest energy setting and the corresponding lower face side.
159198|NCT01713998|O2|Outcome|Group B|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.
159199|NCT01713998|O1|Outcome|Group A|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.
159200|NCT01713998|O3|Outcome|Group C|Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4-4.5mm transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7-4.5mm transducer at the (standard) highest energy setting on the contralateral side of the upper face. For Group C, the standard energy side is defined as the upper face side treated with the 7-4.5mm transducer at the highest energy setting and the corresponding lower face side; the adjusted energy side is defined as the upper face side treated with 4-4.5mm transducer at the second highest energy setting and the corresponding lower face side.
159201|NCT01713998|O2|Outcome|Group B|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.
159202|NCT01713998|O1|Outcome|Group A|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.
159203|NCT01713998|O3|Outcome|Group C|Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4-4.5mm transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7-4.5mm transducer at the (standard) highest energy setting on the contralateral side of the upper face. For Group C, the standard energy side is defined as the upper face side treated with the 7-4.5mm transducer at the highest energy setting and the corresponding lower face side; the adjusted energy side is defined as the upper face side treated with 4-4.5mm transducer at the second highest energy setting and the corresponding lower face side.
159204|NCT01713998|O2|Outcome|Group B|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.
159205|NCT01713998|O1|Outcome|Group A|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.
159242|NCT01713621|B1|Baseline|OZ439 100mg|Single dose of 100mg of OZ439 administered as an oral suspension
159243|NCT01713621|P2|Participant Flow|OZ439 500mg|Single dose of 500mg of OZ439 administered as an oral suspension
159244|NCT01713621|P1|Participant Flow|OZ439 100mg|Single dose of 100mg of OZ439 administered as an oral suspension
159206|NCT01713998|O3|Outcome|Group C|Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4 MHz transducer was used at the (adjusted) second highest energy setting on one side of the upper face, and the 7 MHz transducer at the (standard) highest energy setting on the contralateral side of the upper face. For Group C, the standard energy side is defined as the upper face side treated with the 7 MHz transducer at the highest energy setting and the corresponding lower face side; the adjusted energy side is defined as the upper face side treated with 4 MHz transducer at the second highest energy setting and the corresponding lower face side.
159207|NCT01713998|O2|Outcome|Group B|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.
159208|NCT01713998|O1|Outcome|Group A|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.
159209|NCT01713998|O3|Outcome|Group C|Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4 MHz transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7 MHz transducer at the (standard) highest energy setting on the contralateral side of the upper face. For this outcome measure, only pain score data reported for the brow regions (using standard versus adjusted energy settings) were included.
159210|NCT01713998|O2|Outcome|Group B|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.
159211|NCT01713998|O1|Outcome|Group A|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.
159212|NCT01713998|E1|Reported Event|Study Population|Includes all subjects meeting entrance criteria, consented for participation, enrolled and randomized.
159213|NCT01713933|B1|Baseline|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
159214|NCT01713933|P1|Participant Flow|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
159215|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
159216|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
159217|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
159218|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
159219|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
159220|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
159221|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
159222|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
159223|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
159224|NCT01713933|E1|Reported Event|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
159225|NCT01713686|B1|Baseline|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
159226|NCT01713686|P1|Participant Flow|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
159227|NCT01713686|O1|Outcome|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
159228|NCT01713686|O1|Outcome|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
159229|NCT01713686|O1|Outcome|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
159230|NCT01713686|O1|Outcome|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
159231|NCT01713686|O1|Outcome|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
159232|NCT01713686|O1|Outcome|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
159233|NCT01713686|E1|Reported Event|Ulthera System Treatment|"A single triple depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
159234|NCT01713660|B1|Baseline|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
159235|NCT01713660|P1|Participant Flow|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
159236|NCT01713660|O1|Outcome|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
159237|NCT01713660|O1|Outcome|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
159248|NCT01713621|E1|Reported Event|OZ439 100mg|Single dose of 100mg of OZ439 administered as an oral suspension
159249|NCT01713608|B5|Baseline|Total|Total of all reporting groups
159250|NCT01713608|B4|Baseline|Placebo|Placebo to match OZ439 PIB for oral suspension
159251|NCT01713608|B3|Baseline|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
159252|NCT01713608|B2|Baseline|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
159253|NCT01713608|B1|Baseline|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
159254|NCT01713608|P4|Participant Flow|Placebo|Placebo to match OZ439 PIB for oral suspension
159255|NCT01713608|P3|Participant Flow|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
159256|NCT01713608|P2|Participant Flow|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
159257|NCT01713608|P1|Participant Flow|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
159258|NCT01713608|O3|Outcome|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
159259|NCT01713608|O2|Outcome|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
159260|NCT01713608|O1|Outcome|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
159261|NCT01713608|O3|Outcome|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
159262|NCT01713608|O2|Outcome|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
159263|NCT01713608|O1|Outcome|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
159264|NCT01713608|O3|Outcome|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
159265|NCT01713608|O2|Outcome|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
159266|NCT01713608|O1|Outcome|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
159267|NCT01713608|O3|Outcome|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
159268|NCT01713608|O2|Outcome|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
159269|NCT01713608|O1|Outcome|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
159270|NCT01713608|E4|Reported Event|Placebo|Placebo to match OZ439 PIB for oral suspension
159271|NCT01713608|E3|Reported Event|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
159272|NCT01713608|E2|Reported Event|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
159273|NCT01713608|E1|Reported Event|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
159274|NCT01713530|B3|Baseline|Total|Total of all reporting groups
159275|NCT01713530|B2|Baseline|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
159276|NCT01713530|B1|Baseline|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
159277|NCT01713530|P2|Participant Flow|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
159278|NCT01713530|P1|Participant Flow|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
159279|NCT01713530|O2|Outcome|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
159280|NCT01713530|O1|Outcome|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
173051|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
159281|NCT01713530|O2|Outcome|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
159282|NCT01713530|O1|Outcome|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
159283|NCT01713530|O2|Outcome|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
159284|NCT01713530|O1|Outcome|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
159285|NCT01713530|O2|Outcome|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
159286|NCT01713530|O1|Outcome|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
159287|NCT01713530|O2|Outcome|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
159288|NCT01713530|O1|Outcome|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
159289|NCT01713530|O2|Outcome|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
159290|NCT01713530|O1|Outcome|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
159291|NCT01713530|E2|Reported Event|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
159312|NCT01713348|P1|Participant Flow|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
173052|NCT01665170|O1|Outcome|Placebo|Placebo arm
159292|NCT01713530|E1|Reported Event|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
159293|NCT01713400|B3|Baseline|Total|Total of all reporting groups
159294|NCT01713400|B2|Baseline|Placebo|Placebo, Tacrolimus, and Sirolimus. Placebo: Identical volume to that of ustekinumab. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
159295|NCT01713400|B1|Baseline|Ustekinumab|Ustekinumab, Tacrolimus and Sirolimus. Ustekinumab: 45 mg for adults who weight 100 kg or less; 90 mg for adults who weight greater than 100 kg. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
159296|NCT01713400|P2|Participant Flow|Placebo|Placebo, Tacrolimus, and Sirolimus. Placebo: Identical volume to that of ustekinumab. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
159297|NCT01713400|P1|Participant Flow|Ustekinumab|Ustekinumab, Tacrolimus and Sirolimus. Ustekinumab: 45 mg for adults who weight 100 kg or less; 90 mg for adults who weight greater than 100 kg. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
159298|NCT01713400|O2|Outcome|Placebo|Placebo, Tacrolimus, and Sirolimus. Placebo: Identical volume to that of ustekinumab. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
159299|NCT01713400|O1|Outcome|Ustekinumab|Ustekinumab, Tacrolimus and Sirolimus. Ustekinumab: 45 mg for adults who weight 100 kg or less; 90 mg for adults who weight greater than 100 kg. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
159300|NCT01713400|O2|Outcome|Placebo|Placebo, Tacrolimus, and Sirolimus. Placebo: Identical volume to that of ustekinumab. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
159301|NCT01713400|O1|Outcome|Ustekinumab|Ustekinumab, Tacrolimus and Sirolimus. Ustekinumab: 45 mg for adults who weight 100 kg or less; 90 mg for adults who weight greater than 100 kg. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
159302|NCT01713400|E2|Reported Event|Placebo|Placebo, Tacrolimus, and Sirolimus. Placebo: Identical volume to that of ustekinumab. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
159303|NCT01713400|E1|Reported Event|Ustekinumab|Ustekinumab, Tacrolimus and Sirolimus. Ustekinumab: 45 mg for adults who weight 100 kg or less; 90 mg for adults who weight greater than 100 kg. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
159304|NCT01713348|B5|Baseline|Total|Total of all reporting groups
159305|NCT01713348|B4|Baseline|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
159306|NCT01713348|B3|Baseline|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
159307|NCT01713348|B2|Baseline|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
159308|NCT01713348|B1|Baseline|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
159309|NCT01713348|P4|Participant Flow|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
159310|NCT01713348|P3|Participant Flow|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
159311|NCT01713348|P2|Participant Flow|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
159495|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
159496|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
159313|NCT01713348|O4|Outcome|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
159314|NCT01713348|O3|Outcome|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
159315|NCT01713348|O2|Outcome|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
159316|NCT01713348|O1|Outcome|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
159317|NCT01713348|O4|Outcome|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
159318|NCT01713348|O3|Outcome|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
159319|NCT01713348|O2|Outcome|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
159320|NCT01713348|O1|Outcome|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
159321|NCT01713348|O4|Outcome|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
159322|NCT01713348|O3|Outcome|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
159323|NCT01713348|O2|Outcome|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
159324|NCT01713348|O1|Outcome|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
159325|NCT01713348|O4|Outcome|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
159326|NCT01713348|O3|Outcome|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
159327|NCT01713348|O2|Outcome|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
159328|NCT01713348|O1|Outcome|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
159329|NCT01713348|O4|Outcome|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
159330|NCT01713348|O3|Outcome|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
159331|NCT01713348|O2|Outcome|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
159332|NCT01713348|O1|Outcome|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
159333|NCT01713348|E4|Reported Event|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100."
159497|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
159498|NCT01712516|O4|Outcome|Placebo|b.i.d.
159334|NCT01713348|E3|Reported Event|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
159335|NCT01713348|E2|Reported Event|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100."
159336|NCT01713348|E1|Reported Event|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
159337|NCT01713283|B5|Baseline|Total|Total of all reporting groups
159338|NCT01713283|B4|Baseline|SOF+RBV 24 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
159339|NCT01713283|B3|Baseline|SOF+RBV 24 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
159340|NCT01713283|B2|Baseline|SOF+RBV 12 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced (TE))
159341|NCT01713283|B1|Baseline|SOF+RBV 12 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive (TN))
159342|NCT01713283|P2|Participant Flow|SOF+RBV 24 Wk|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
159343|NCT01713283|P1|Participant Flow|SOF+RBV 12 Wk|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks
159344|NCT01713283|O4|Outcome|SOF+RBV 24 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
159345|NCT01713283|O3|Outcome|SOF+RBV 24 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
159346|NCT01713283|O2|Outcome|SOF+RBV 12 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
159347|NCT01713283|O1|Outcome|SOF+RBV 12 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
159348|NCT01713283|O4|Outcome|SOF+RBV 24 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
159349|NCT01713283|O3|Outcome|SOF+RBV 24 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
159350|NCT01713283|O2|Outcome|SOF+RBV 12 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
159351|NCT01713283|O1|Outcome|SOF+RBV 12 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
159352|NCT01713283|O4|Outcome|SOF+RBV 24 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
159353|NCT01713283|O3|Outcome|SOF+RBV 24 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
159354|NCT01713283|O2|Outcome|SOF+RBV 12 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
159355|NCT01713283|O1|Outcome|SOF+RBV 12 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
159356|NCT01713283|O2|Outcome|SOF+RBV 24 Wk|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
159357|NCT01713283|O1|Outcome|SOF+RBV 12 Wk|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
159358|NCT01713283|O4|Outcome|SOF+RBV 24 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
159359|NCT01713283|O3|Outcome|SOF+RBV 24 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
159360|NCT01713283|O2|Outcome|SOF+RBV 12 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
159361|NCT01713283|O1|Outcome|SOF+RBV 12 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
159362|NCT01713283|E2|Reported Event|SOF+RBV 24 Wk|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
159363|NCT01713283|E1|Reported Event|SOF+RBV 12 Wk|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
159364|NCT01713036|B1|Baseline|Pimasertib|Part A: Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection. On Days 3-21 (except Day 8), subjects received unlabeled pimasertib capsules orally at a dose of 60 mg twice daily (BID). In the morning of Day 8, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally. In the evening of Day 8, subjects received the evening dose of 60 mg pimasertib as unlabeled pimasertib capsules orally. Part B: Subjects were administered with 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.
159365|NCT01713036|P1|Participant Flow|Pimasertib|Part A: Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 milligram (mg) on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kilobecquerel (kBq) [14C] pimasertib was administered as a bolus injection. On Days 3-21 (except Day 8), subjects received unlabeled pimasertib capsules orally at a dose of 60 mg twice daily (BID). In the morning of Day 8, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 megabecquerel (MBq) (70 microcuries [mcgCi]) of [14C] pimasertib orally. In the evening of Day 8, subjects received the evening dose of 60 mg pimasertib as unlabeled pimasertib capsules orally. Part B : Subjects were administered with 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.
159366|NCT01713036|O1|Outcome|Pimasertib|Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 milligram (mg) on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kilobecquerel (kBq) [14C] pimasertib was administered as a bolus injection. On Days 3-21 (except Day 8), subjects received unlabeled pimasertib capsules orally at a dose of 60 mg twice daily (BID). In the morning of Day 8, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 megabecquerel (MBq) (70 microcuries [μCi]) of [14C] pimasertib orally. In the evening of Day 8, subjects received the evening dose of 60 mg pimasertib as unlabeled pimasertib capsules orally. Part B : Subjects were administered with 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.
159367|NCT01713036|O1|Outcome|Pimasertib|Part B : Subjects received 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.
159368|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
159369|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
159370|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of metabolites, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
159371|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of metabolites, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
159372|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of metabolites, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
159373|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of metabolites, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
159374|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of metabolites, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
159375|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of metabolites, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
159376|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
159377|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
159378|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
159379|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
159380|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
159381|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
159382|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
159383|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
159384|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
159385|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
159386|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
159387|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
159388|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
159389|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
159390|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
159391|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
159392|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
159393|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
159499|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
159394|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of mass balance, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
159395|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
159396|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
159397|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
159398|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
159399|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
159400|NCT01713036|E1|Reported Event|Pimasertib|Part A: Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the IV tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection. On Days 3-21 (except Day 8), subjects received unlabeled pimasertib capsules orally at a dose of 60 mg twice daily (BID). In the morning of Day 8, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 μCi) of [14C] pimasertib orally. In the evening of Day 8, subjects received the evening dose of 60 mg pimasertib as unlabeled pimasertib capsules orally. Part B: Subjects were administered with 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.
159401|NCT01712984|B4|Baseline|Total|Total of all reporting groups
159402|NCT01712984|B3|Baseline|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
159403|NCT01712984|B2|Baseline|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
159404|NCT01712984|B1|Baseline|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
159405|NCT01712984|P3|Participant Flow|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
159406|NCT01712984|P2|Participant Flow|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
159407|NCT01712984|P1|Participant Flow|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
159408|NCT01712984|O3|Outcome|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
159409|NCT01712984|O2|Outcome|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
159410|NCT01712984|O1|Outcome|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
159411|NCT01712984|O3|Outcome|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
159412|NCT01712984|O2|Outcome|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
159413|NCT01712984|O1|Outcome|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
159414|NCT01712984|O3|Outcome|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
159415|NCT01712984|O2|Outcome|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
159416|NCT01712984|O1|Outcome|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
159417|NCT01712984|O3|Outcome|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
159418|NCT01712984|O2|Outcome|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
159419|NCT01712984|O1|Outcome|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
159420|NCT01712984|O3|Outcome|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
159421|NCT01712984|O2|Outcome|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
159422|NCT01712984|O1|Outcome|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
159423|NCT01712984|E3|Reported Event|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
159424|NCT01712984|E2|Reported Event|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
159425|NCT01712984|E1|Reported Event|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
159426|NCT01712854|B1|Baseline|Active Medication or Placebo|Data per arm is not available. Columbia will never have access to this data.
159427|NCT01712854|P1|Participant Flow|Active Medication or Placebo|Data per arm is not available. Columbia will never have access to this data.
159428|NCT01712854|O1|Outcome|Active Medication or Placebo|Data per arm is not available. Columbia will never have access to this data.
159429|NCT01712854|O1|Outcome|Active Medication or Placebo|Data per arm is not available. Columbia will never have access to this data.
159430|NCT01712854|E1|Reported Event|Active Medication or Placebo|Data per arm is not available. Columbia will never have access to this data.
159431|NCT01712776|B3|Baseline|Total|Total of all reporting groups
159432|NCT01712776|B2|Baseline|Nature's Tears|"Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.~Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin."
159433|NCT01712776|B1|Baseline|Vapocoolant (Pain Ease Medium Stream )|"Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.~Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin."
159434|NCT01712776|P2|Participant Flow|Vapocoolant (Pain Ease Medium Stream )|"Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.~Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin."
159435|NCT01712776|P1|Participant Flow|Placebo (Normal Saline, Nature&Apos;s Tears)|"Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.~Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin."
159436|NCT01712776|O2|Outcome|Nature's Tears|"Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.~Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin."
159437|NCT01712776|O1|Outcome|Vapocoolant (Pain Ease Medium Stream )|"Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.~Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin."
159438|NCT01712776|E2|Reported Event|Nature's Tears|"Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.~Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin."
159439|NCT01712776|E1|Reported Event|Vapocoolant (Pain Ease Medium Stream )|"Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.~Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin."
159440|NCT01712711|B3|Baseline|Total|Total of all reporting groups
159441|NCT01712711|B2|Baseline|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
159442|NCT01712711|B1|Baseline|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
159443|NCT01712711|P2|Participant Flow|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
159444|NCT01712711|P1|Participant Flow|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
159445|NCT01712711|O2|Outcome|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
159446|NCT01712711|O1|Outcome|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
159447|NCT01712711|E2|Reported Event|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
159448|NCT01712711|E1|Reported Event|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
159449|NCT01712685|B1|Baseline|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
159450|NCT01712685|P1|Participant Flow|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
159451|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
159452|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
159500|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
159501|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
159453|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
159454|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
159455|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
159456|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
159457|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
159458|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
159459|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
159460|NCT01712685|E1|Reported Event|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
159461|NCT01712516|B5|Baseline|Total|Total of all reporting groups
159462|NCT01712516|B4|Baseline|Placebo|b.i.d.
159463|NCT01712516|B3|Baseline|NVA237|12.5 ug b.i.d.
159464|NCT01712516|B2|Baseline|QAB149|27.5 ug b.i.d.
159465|NCT01712516|B1|Baseline|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
159466|NCT01712516|P4|Participant Flow|Placebo|b.i.d.
159467|NCT01712516|P3|Participant Flow|NVA237|12.5 ug b.i.d.
159468|NCT01712516|P2|Participant Flow|QAB149|27.5 ug b.i.d.
159469|NCT01712516|P1|Participant Flow|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
159470|NCT01712516|O4|Outcome|Placebo|b.i.d.
159471|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
159472|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
159473|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
159474|NCT01712516|O4|Outcome|Placebo|b.i.d.
159475|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
159476|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
159477|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
159478|NCT01712516|O4|Outcome|Placebo|b.i.d.
159479|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
159480|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
159481|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
159482|NCT01712516|O4|Outcome|Placebo|b.i.d.
159483|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
159484|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
159485|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
159486|NCT01712516|O4|Outcome|Placebo|b.i.d.
159487|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
159488|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
159489|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
159490|NCT01712516|O4|Outcome|Placebo|b.i.d.
159491|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
159492|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
159493|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
159494|NCT01712516|O4|Outcome|Placebo|b.i.d.
159505|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
159506|NCT01712516|O4|Outcome|Placebo|b.i.d.
159507|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
159508|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
159509|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
159510|NCT01712516|O4|Outcome|Placebo|b.i.d.
159511|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
159512|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
159513|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
159514|NCT01712516|E4|Reported Event|Placebo|b.i.d.
159515|NCT01712516|E3|Reported Event|NVA237|12.5 ug b.i.d.
159516|NCT01712516|E2|Reported Event|QAB149|27.5 ug b.i.d.
159517|NCT01712516|E1|Reported Event|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
159518|NCT01712399|B1|Baseline|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
159519|NCT01712399|P1|Participant Flow|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
159520|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
159521|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
159522|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
159523|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
159524|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
159525|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
159526|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
159527|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
159528|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
159529|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
159530|NCT01712399|E1|Reported Event|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
159531|NCT01712360|B5|Baseline|Total|Total of all reporting groups
159532|NCT01712360|B4|Baseline|NAFT600 (Adult)|"Topical once a day for two weeks~NAFT600 (adult): Applied to both feet"
159533|NCT01712360|B3|Baseline|NAFT500 (Adult)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
159534|NCT01712360|B2|Baseline|NAFT600 (Pediatric)|"Topical once a day for two weeks~NAFT600 (pediatric): Applied to both feet only"
159535|NCT01712360|B1|Baseline|NAFT500 (Pediatric)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
159536|NCT01712360|P4|Participant Flow|NAFT600 (Adult)|"Topical once a day for two weeks~NAFT600 (adult): Applied to both feet"
159537|NCT01712360|P3|Participant Flow|NAFT500 (Adult)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
159538|NCT01712360|P2|Participant Flow|NAFT600 (Pediatric)|"Topical once a day for two weeks~NAFT600 (pediatric): Applied to both feet only"
159539|NCT01712360|P1|Participant Flow|NAFT500 (Pediatric)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
159540|NCT01712360|O6|Outcome|NAFT600 (Adult)|"Topical once a day for two weeks~NAFT600 (adult): Applied to both feet"
159541|NCT01712360|O5|Outcome|NAFT600 (Pediatric)|"Topical once a day for two weeks~NAFT600 (pediatric): Applied to both feet only"
159542|NCT01712360|O4|Outcome|NAFT500 (Adult, Groin)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
159543|NCT01712360|O3|Outcome|NAFT500 (Pediatric, Groin)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
159544|NCT01712360|O2|Outcome|NAFT500 (Adult, Foot)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
159545|NCT01712360|O1|Outcome|NAFT500 (Pediatric, Foot)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
159546|NCT01712360|O4|Outcome|NAFT600 (Adult)|"Topical once a day for two weeks~NAFT600 (adult): Applied to both feet"
159547|NCT01712360|O3|Outcome|NAFT500 (Adult)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
159548|NCT01712360|O2|Outcome|NAFT600 (Pediatric)|"Topical once a day for two weeks~NAFT600 (pediatric): Applied to both feet only"
159549|NCT01712360|O1|Outcome|NAFT500 (Pediatric)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
159550|NCT01712360|O6|Outcome|NAFT600 (Adult)|"Topical once a day for two weeks~NAFT600 (adult): Applied to both feet"
159551|NCT01712360|O5|Outcome|NAFT600 (Pediatric)|"Topical once a day for two weeks~NAFT600 (pediatric): Applied to both feet only"
159552|NCT01712360|O4|Outcome|NAFT500 (Adult, Groin)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
159553|NCT01712360|O3|Outcome|NAFT500 (Pediatric, Groin)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
159554|NCT01712360|O2|Outcome|NAFT500 (Adult, Foot)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
159555|NCT01712360|O1|Outcome|NAFT500 (Pediatric, Foot)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
159556|NCT01712360|O4|Outcome|NAFT600 (Adult)|"Topical once a day for two weeks~NAFT600 (adult): Applied to both feet"
159557|NCT01712360|O3|Outcome|NAFT500 (Adult)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
159558|NCT01712360|O2|Outcome|NAFT600 (Pediatric)|"Topical once a day for two weeks~NAFT600 (pediatric): Applied to both feet only"
159559|NCT01712360|O1|Outcome|NAFT500 (Pediatric)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
159560|NCT01712360|E4|Reported Event|NAFT600 (Adult)|"Topical once a day for two weeks~NAFT600 (adult): Applied to both feet"
159561|NCT01712360|E3|Reported Event|NAFT500 (Adult)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
159562|NCT01712360|E2|Reported Event|NAFT600 (Pediatric)|"Topical once a day for two weeks~NAFT600 (pediatric): Applied to both feet only"
159563|NCT01712360|E1|Reported Event|NAFT500 (Pediatric)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
159564|NCT01712334|B1|Baseline|All Participants|All participants received dornase alfa (Pulmozyme) inhaled once daily by the Pari eRapid nebulizer or the Pari LC Plus jet nebulizer for 2 weeks in Treatment Period 1 then crossed over to use the other nebulizer in Treatment Period 2 for 2 weeks.
159565|NCT01712334|P2|Participant Flow|Jet Nebulizer Then eRapid Nebulizer|Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks in Treatment Period 1 then Pulmozyme® inhaled once daily by the Pari eRapid nebulizer for 2 weeks in Treatment Period 2.
159566|NCT01712334|P1|Participant Flow|eRapid Nebulizer Then Jet Nebulizer|Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks in Treatment Period 1 then Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks in Treatment Period 2.
159567|NCT01712334|O2|Outcome|Jet Nebulizer|Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks.
159568|NCT01712334|O1|Outcome|eRapid Nebulizer|Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks.
159569|NCT01712334|O2|Outcome|Jet Nebulizer|Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks.
159570|NCT01712334|O1|Outcome|eRapid Nebulizer|Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks.
159571|NCT01712334|E2|Reported Event|Jet Nebulizer|Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks.
159572|NCT01712334|E1|Reported Event|eRapid Nebulizer|Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks.
159573|NCT01712256|B1|Baseline|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.~Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
159574|NCT01712256|P1|Participant Flow|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.~Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
159575|NCT01712256|O1|Outcome|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.~Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
159576|NCT01712256|O1|Outcome|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.~Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
159577|NCT01712256|O1|Outcome|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.~Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
159578|NCT01712256|O1|Outcome|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.~Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
159579|NCT01712256|O1|Outcome|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.~Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
159580|NCT01712256|O1|Outcome|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.~Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
159581|NCT01712256|E1|Reported Event|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.~Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
159582|NCT01712204|B3|Baseline|Total|Total of all reporting groups
159583|NCT01712204|B2|Baseline|AC-201 50mg Capsule BID|AC-201 50mg Capsule BID for 16 Weeks
159584|NCT01712204|B1|Baseline|Placebo Capsule BID|Placebo Capsule BID for 16 Weeks
159585|NCT01712204|P2|Participant Flow|AC-201|AC-201 50mg Capsule BID for 16 Weeks
159586|NCT01712204|P1|Participant Flow|Placebo|Placebo Capsule BID for 16 Weeks
159587|NCT01712204|O2|Outcome|AC-201|"AC-201 50mg Capsule BID for 16 Weeks~Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)"
159588|NCT01712204|O1|Outcome|Placebo|"Placebo Capsule BID for 16 Weeks~Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)"
159589|NCT01712204|E2|Reported Event|AC-201|"AC-201 50mg Capsule BID for 16 Weeks~Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)"
159590|NCT01712204|E1|Reported Event|Placebo|"Placebo Capsule BID for 16 Weeks~Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)"
159591|NCT01712178|B3|Baseline|Total|Total of all reporting groups
159592|NCT01712178|B2|Baseline|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
159593|NCT01712178|B1|Baseline|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
159594|NCT01712178|P2|Participant Flow|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
159595|NCT01712178|P1|Participant Flow|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
159636|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing vital signs data during double blind period
159596|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
159597|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
159598|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
159599|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
159600|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
159601|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
159602|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
159603|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
159604|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
159605|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
159606|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
159607|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
159608|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
159609|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
159610|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
159611|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
159612|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
159613|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
159614|NCT01712178|E2|Reported Event|Current Formulation Adalimumab 40 mg Every Other Week|
159615|NCT01712178|E1|Reported Event|New Formulation of Adalimumab 40 mg Every Other Week|
159616|NCT01712074|B4|Baseline|Total|Total of all reporting groups
159617|NCT01712074|B3|Baseline|Placebo: Double Blind Period|All participants entered the double blind period and received placebo
159618|NCT01712074|B2|Baseline|PF-05212377 30 mg: Double Blind Period|All participants entered the double blind period and received PF-05212377 30 mg
159619|NCT01712074|B1|Baseline|Not Randomized|Participants who have been discontinued during the Placebo Run-In period
159620|NCT01712074|P3|Participant Flow|Placebo: Double Blind Period|All participants that received placebo during the 12-week double blind period
159621|NCT01712074|P2|Participant Flow|PF-05212377 30 mg: Double Blind Period|All participants that received PF-05212377 30 mg during the 12-week double blind period
159622|NCT01712074|P1|Participant Flow|Placebo Run-In|Participants that received placebo during the 4-week single blind placebo run-in period
159623|NCT01712074|O3|Outcome|Placebo|All participants received placebo during double blind period
159624|NCT01712074|O2|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
159625|NCT01712074|O1|Outcome|Placebo Run-in|All participants assigned to the placebo run-in period
159626|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo during double blind period
159627|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
159628|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing vital signs data during double blind period
159629|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
159630|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing vital signs data during double blind period
159631|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
159632|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing vital signs data during double blind period
159633|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
159634|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing vital signs data during double blind period
159635|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
162031|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
159637|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
159638|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing vital signs data during double blind period
159639|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
159640|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
159641|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
159642|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
159643|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
159644|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
159645|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
159646|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
159647|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
159648|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
159649|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
159650|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
159651|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
159652|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
159653|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
159654|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
159655|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
159656|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
159657|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
159658|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
159659|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
159660|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
159661|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
159662|NCT01712074|O2|Outcome|Placebo|All participants who received placebo with non-missing ECG data during the double blind period
159663|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
159664|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing clinical laboratory data during double blind period
159665|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
159666|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo during double blind period
159667|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
159668|NCT01712074|O2|Outcome|Placebo|All participants who received placebo contributing to the analysis during the double blind period
159669|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
159670|NCT01712074|O2|Outcome|Placebo|All participants who received placebo contributing to the analysis during the double blind period
159671|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
159672|NCT01712074|E3|Reported Event|Placebo|All participants receiving placebo during double blind period
159673|NCT01712074|E2|Reported Event|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
159674|NCT01712074|E1|Reported Event|Placebo Run-In|Participants received placebo during the single blind placebo run-in period
159675|NCT01712061|B3|Baseline|Total|Total of all reporting groups
159676|NCT01712061|B2|Baseline|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
159677|NCT01712061|B1|Baseline|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
159678|NCT01712061|P3|Participant Flow|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
159679|NCT01712061|P2|Participant Flow|PF-04634817 200 mg|Participants with eGFR values of 30 to 75 mL/min/1.73 m^2 were dosed orally at 200 mg QD for 12 weeks.
159680|NCT01712061|P1|Participant Flow|PF-04634817 150 mg|Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (<)30 milliliters/minute (mL/min)/1.73 square meter (m^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.
159681|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
159682|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
159683|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
159684|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
159685|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
159686|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
159687|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
159688|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
159689|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
159690|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
159691|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
159692|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
159693|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
159694|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
159695|NCT01712061|O2|Outcome|PF-04634817 200 mg|Participants with eGFR values of 30 to 75 mL/min/1.73 m^2 were dosed orally at 200 mg QD for 12 weeks.
159696|NCT01712061|O1|Outcome|PF-04634817 150 mg|Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (<)30 milliliters/minute (mL/min)/1.73 square meter (m^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.
159697|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
159698|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
159699|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
159700|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
159701|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
159702|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
159703|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
159704|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
159705|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
159706|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
159707|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
159708|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
159709|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
159710|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
159711|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
159712|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
159713|NCT01712061|E3|Reported Event|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
159714|NCT01712061|E2|Reported Event|PF-04634817 200 mg|Participants with eGFR values of 30 to 75 mL/min/1.73 m^2 were dosed orally at 200 mg QD for 12 weeks.
159715|NCT01712061|E1|Reported Event|PF-04634817 150 mg|Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (<)30 milliliters/minute (mL/min)/1.73 square meter (m^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.
159716|NCT01712009|B4|Baseline|Total|Total of all reporting groups
159717|NCT01712009|B3|Baseline|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
159718|NCT01712009|B2|Baseline|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
159719|NCT01712009|B1|Baseline|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
159720|NCT01712009|P3|Participant Flow|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
159721|NCT01712009|P2|Participant Flow|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
159722|NCT01712009|P1|Participant Flow|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
159723|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
159724|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
159725|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
159726|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
159727|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
159728|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
159729|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
159730|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
159731|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
159732|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
159733|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
159734|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
159735|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
159736|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
159737|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
159738|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
159739|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
159740|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
159741|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
159742|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
159743|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
159744|NCT01712009|E3|Reported Event|Loratadine 10mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
159745|NCT01712009|E2|Reported Event|Naproxen 500mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
159746|NCT01712009|E1|Reported Event|No Prophylactic Intervention|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
159747|NCT01711918|B1|Baseline|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
159748|NCT01711918|P1|Participant Flow|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
159749|NCT01711918|O1|Outcome|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
159750|NCT01711918|O1|Outcome|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
159751|NCT01711918|O1|Outcome|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
159752|NCT01711918|O1|Outcome|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
159753|NCT01711918|O1|Outcome|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
159754|NCT01711918|E1|Reported Event|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
159772|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159816|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159755|NCT01711866|B1|Baseline|Rotigotine|"First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.~Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.~Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.~Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks."
159756|NCT01711866|P1|Participant Flow|Rotigotine|"First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.~Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.~Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.~Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks."
159757|NCT01711866|O1|Outcome|Rotigotine|"First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.~Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.~Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.~Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks."
159758|NCT01711866|O1|Outcome|Rotigotine|"First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.~Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.~Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.~Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks."
159759|NCT01711866|E1|Reported Event|Rotigotine|"First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.~Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.~Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.~Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks."
159760|NCT01711853|B1|Baseline|Dabigatran 75 mg|Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
159761|NCT01711853|P1|Participant Flow|Dabigatran 75 mg|Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
159762|NCT01711853|O1|Outcome|Dabigatran 75 mg|Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
159763|NCT01711853|O1|Outcome|Dabigatran 75 mg|Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
159764|NCT01711853|E1|Reported Event|Dabigatran 75 mg|Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
159765|NCT01711736|B3|Baseline|Total|Total of all reporting groups
159766|NCT01711736|B2|Baseline|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159767|NCT01711736|B1|Baseline|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159768|NCT01711736|P2|Participant Flow|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159769|NCT01711736|P1|Participant Flow|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159770|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159771|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
160052|NCT01710657|O1|Outcome|Placebo|"Matching Placebo for 16 weeks.~Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
159773|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159774|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159775|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159776|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159777|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159778|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159779|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159780|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159781|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159782|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159783|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159784|NCT01711736|O1|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159785|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159786|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159787|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159788|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159789|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159790|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159815|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159791|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159792|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159793|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159794|NCT01711736|E2|Reported Event|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159795|NCT01711736|E1|Reported Event|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
159796|NCT01711645|B1|Baseline|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159797|NCT01711645|P1|Participant Flow|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159798|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159799|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159800|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159801|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159802|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159803|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159804|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159805|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159806|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159807|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159808|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159809|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159810|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159811|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159812|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159813|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159814|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
160018|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
159817|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159818|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159819|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159820|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159821|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159822|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159823|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159824|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159825|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159826|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159827|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159828|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159829|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159830|NCT01711645|E1|Reported Event|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
159831|NCT01711424|B1|Baseline|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
159832|NCT01711424|P1|Participant Flow|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
159833|NCT01711424|O1|Outcome|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
159834|NCT01711424|O1|Outcome|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
159835|NCT01711424|O1|Outcome|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
159836|NCT01711424|O1|Outcome|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
159837|NCT01711424|E1|Reported Event|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
159838|NCT01711359|B4|Baseline|Total|Total of all reporting groups
159839|NCT01711359|B3|Baseline|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159840|NCT01711359|B2|Baseline|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159841|NCT01711359|B1|Baseline|Methotrexate|Methotrexate (MTX) administered orally once weekly with dose ranging from 10 to 20 milligram (mg) per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159842|NCT01711359|P3|Participant Flow|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159843|NCT01711359|P2|Participant Flow|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159844|NCT01711359|P1|Participant Flow|Methotrexate|Methotrexate (MTX) administered orally once weekly with dose ranging from 10 to 20 milligram (mg) per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159845|NCT01711359|O1|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159846|NCT01711359|O1|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159847|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159848|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159849|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159850|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159851|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159852|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159853|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159854|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159855|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159856|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159857|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159858|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159859|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159860|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159861|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159862|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159863|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159864|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159865|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159866|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159867|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159868|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159869|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159870|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159871|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159872|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159873|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159874|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159875|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159876|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159877|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159878|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159879|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159880|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159881|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159882|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159883|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159884|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159885|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159886|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159887|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159888|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159889|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159890|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159891|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159892|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159893|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159894|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159895|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159896|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159897|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159898|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159899|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159900|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159901|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159902|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159903|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159904|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159905|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159906|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159907|NCT01711359|E7|Reported Event|Baricitinib + MTX - Follow-up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug. Includes participants who were rescued to Baricitinib + MTX.
159908|NCT01711359|E6|Reported Event|Baricitinib - Follow-up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
159909|NCT01711359|E5|Reported Event|Methotrexate - Follow-up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
159910|NCT01711359|E4|Reported Event|Rescue Period|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52.
159911|NCT01711359|E3|Reported Event|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159912|NCT01711359|E2|Reported Event|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
160019|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
159913|NCT01711359|E1|Reported Event|Methotrexate|Methotrexate (MTX) administered orally once weekly with dose ranging from 10 to 20 milligram (mg) per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
159914|NCT01711216|B1|Baseline|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
159915|NCT01711216|P1|Participant Flow|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
159916|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
159917|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
159918|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
159919|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
159920|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
159921|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
159922|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
159923|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
159924|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
159925|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
159926|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
159927|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
159928|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
159929|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
159930|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
159931|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
159932|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
159933|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
159934|NCT01711216|E1|Reported Event|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
159935|NCT01711177|B4|Baseline|Total|Total of all reporting groups
159936|NCT01711177|B3|Baseline|Newly Diagnosed Glaucoma|"Treated with Travoprost (0.04%)~travoprost: Travatan Z is administered to newly diagnosed glaucoma patient"
159937|NCT01711177|B2|Baseline|Glaucoma Suspect|"Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)~placebo: Placebo"
159938|NCT01711177|B1|Baseline|Normal Control|"Normal patient placebo~placebo: Placebo"
159939|NCT01711177|P3|Participant Flow|Newly Diagnosed Glaucoma|"Treated with Travoprost (0.04%)~travoprost: Travatan Z is administered to newly diagnosed glaucoma patient"
159940|NCT01711177|P2|Participant Flow|Glaucoma Suspect|"Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)~placebo: Placebo"
159941|NCT01711177|P1|Participant Flow|Normal Control|"Normal patient placebo~placebo: Placebo"
159942|NCT01711177|O3|Outcome|Newly Diagnosed Glaucoma|"Treated with Travoprost (0.04%)~travoprost: Travatan Z is administered to newly diagnosed glaucoma patient"
159943|NCT01711177|O2|Outcome|Glaucoma Suspect|"Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)~placebo: Placebo"
159944|NCT01711177|O1|Outcome|Normal Control|"Normal patient placebo~placebo: Placebo"
159945|NCT01711177|E3|Reported Event|Newly Diagnosed Glaucoma|"Treated with Travoprost (0.04%)~travoprost: Travatan Z is administered to newly diagnosed glaucoma patient"
159946|NCT01711177|E2|Reported Event|Glaucoma Suspect|"Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)~placebo: Placebo"
159947|NCT01711177|E1|Reported Event|Normal Control|"Normal patient placebo~placebo: Placebo"
159948|NCT01710839|B3|Baseline|Total|Total of all reporting groups
159949|NCT01710839|B2|Baseline|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.~0.5mg Ranibizumab: intravitreal injections"
162032|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
159950|NCT01710839|B1|Baseline|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.~0.5mg Ranibizumab: intravitreal injections~Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
159951|NCT01710839|P2|Participant Flow|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.~0.5mg Ranibizumab: intravitreal injections"
159952|NCT01710839|P1|Participant Flow|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.~0.5mg Ranibizumab: intravitreal injections~Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
159953|NCT01710839|O2|Outcome|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.~0.5mg Ranibizumab: intravitreal injections"
159954|NCT01710839|O1|Outcome|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.~0.5mg Ranibizumab: intravitreal injections~Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
159955|NCT01710839|O2|Outcome|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.~0.5mg Ranibizumab: intravitreal injections"
159956|NCT01710839|O1|Outcome|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.~0.5mg Ranibizumab: intravitreal injections~Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
159957|NCT01710839|O2|Outcome|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.~0.5mg Ranibizumab: intravitreal injections"
159958|NCT01710839|O1|Outcome|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.~0.5mg Ranibizumab: intravitreal injections~Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
159959|NCT01710839|O2|Outcome|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.~0.5mg Ranibizumab: intravitreal injections"
159960|NCT01710839|O1|Outcome|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.~0.5mg Ranibizumab: intravitreal injections~Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
159961|NCT01710839|O2|Outcome|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.~0.5mg Ranibizumab: intravitreal injections"
160224|NCT01710345|E1|Reported Event|Sufentanil NanoTab 20 mcg|Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
159962|NCT01710839|O1|Outcome|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.~0.5mg Ranibizumab: intravitreal injections~Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
159963|NCT01710839|O2|Outcome|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.~0.5mg Ranibizumab: intravitreal injections"
159964|NCT01710839|O1|Outcome|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.~0.5mg Ranibizumab: intravitreal injections~Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
159965|NCT01710839|O2|Outcome|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.~0.5mg Ranibizumab: intravitreal injections"
159966|NCT01710839|O1|Outcome|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.~0.5mg Ranibizumab: intravitreal injections~Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
159967|NCT01710839|O2|Outcome|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.~0.5mg Ranibizumab: intravitreal injections"
159968|NCT01710839|O1|Outcome|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.~0.5mg Ranibizumab: intravitreal injections~Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
159969|NCT01710839|O2|Outcome|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.~0.5mg Ranibizumab: intravitreal injections"
159970|NCT01710839|O1|Outcome|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.~0.5mg Ranibizumab: intravitreal injections~Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
159971|NCT01710839|E2|Reported Event|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.~0.5mg Ranibizumab: intravitreal injections"
159972|NCT01710839|E1|Reported Event|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.~0.5mg Ranibizumab: intravitreal injections~Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
159973|NCT01710800|B1|Baseline|All Study Participants|Patients will be randomized to receive either PPI or placebo (sequence 1) and then undergo a 24 hour pH study with impedance to measure the number of reflux episodes. Sequence 2 (placebo or PPI) will be administered followed by repeat 24 hour pH with impedance.
160020|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
159974|NCT01710800|P1|Participant Flow|First Intervention (7 Days), Second Intervention (7 Days)|Patients will be randomized to receive either PPI or placebo (sequence 1) for 7 days and then undergo a 24 hour pH study with impedance to measure the number of reflux episode. The second sequence of medications (that is either placebo or PPI or sequence 2) will be administered followed by repeat 24 hour pH with impedance 7 days later.
159975|NCT01710800|O2|Outcome|Esomeprazole|Patients were randomly assigned to receive 40 mg esomeprazole twice daily prior to undergoing a 24 hour pH study with impedance to measure the number of reflux episodes
159976|NCT01710800|O1|Outcome|Placebo Arm|Patients will be randomized to receive either PPI or placebo and then undergo a 24 hour pH study with impedance to measure the number of reflux episodes
159977|NCT01710800|E2|Reported Event|PPI Arm|
159978|NCT01710800|E1|Reported Event|Placebo Arm|
159979|NCT01710787|B4|Baseline|Total|Total of all reporting groups
159980|NCT01710787|B3|Baseline|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
159981|NCT01710787|B2|Baseline|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
159982|NCT01710787|B1|Baseline|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
159983|NCT01710787|P3|Participant Flow|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
159984|NCT01710787|P2|Participant Flow|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
159985|NCT01710787|P1|Participant Flow|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
159986|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
159987|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
159988|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
159989|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
159990|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
159991|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
159992|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
159993|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
159994|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
159995|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
159996|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
159997|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
159998|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
159999|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
160000|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
160001|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
160002|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
160003|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
160004|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
160005|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
160006|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
160007|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
160008|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
160009|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
160010|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
160011|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
160012|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
160013|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
160014|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
160015|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
160016|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
160017|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
160021|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
160022|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
160023|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
160024|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
160025|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
160026|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
160027|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
160028|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
160029|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
160030|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
160031|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
160032|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
160033|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
160034|NCT01710787|E3|Reported Event|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
160035|NCT01710787|E2|Reported Event|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
160036|NCT01710787|E1|Reported Event|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
160037|NCT01710657|B4|Baseline|Total|Total of all reporting groups
160038|NCT01710657|B3|Baseline|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
160039|NCT01710657|B2|Baseline|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
160040|NCT01710657|B1|Baseline|Placebo|"Matching Placebo for 16 weeks.~Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
160041|NCT01710657|P3|Participant Flow|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
160042|NCT01710657|P2|Participant Flow|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
160043|NCT01710657|P1|Participant Flow|Placebo|"Matching Placebo for 16 weeks.~Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
160044|NCT01710657|O3|Outcome|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
160045|NCT01710657|O2|Outcome|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
160046|NCT01710657|O1|Outcome|Placebo|"Matching Placebo for 16 weeks.~Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
160047|NCT01710657|O3|Outcome|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
160048|NCT01710657|O2|Outcome|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
160049|NCT01710657|O1|Outcome|Placebo|"Matching Placebo for 16 weeks.~Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
160050|NCT01710657|O3|Outcome|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
160051|NCT01710657|O2|Outcome|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
160053|NCT01710657|O3|Outcome|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
160054|NCT01710657|O2|Outcome|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
160055|NCT01710657|O1|Outcome|Placebo|"Matching Placebo for 16 weeks.~Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
160056|NCT01710657|E3|Reported Event|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
160057|NCT01710657|E2|Reported Event|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
160058|NCT01710657|E1|Reported Event|Placebo|"Matching Placebo for 16 weeks.~Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
160059|NCT01710527|B1|Baseline|Treatment T-Metformin 500 mg + Treatment R-Glucophage 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet) or treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
160060|NCT01710527|P2|Participant Flow|Treatment R-Glucophage 500mg, Then Treatment T-Metformin 500mg|Participants received one tablet of treatment R (Glucophage 500 mg tablet) given with 250 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing according to a plan of randomization. After a washout period of 7 days, participants then received one tablet of treatment T (Metformin 500 mg tablet) given with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period.
160061|NCT01710527|P1|Participant Flow|Treatment T-Metformin 500mg, Then Treatment R-Glucophage 500mg|Participants received one tablet of treatment T (Metformin 500 mg tablet) given with 250 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 minutes (min) for up to 4 hours after dosing according to a plan of randomization. After a washout period of 7 days, participants then received one tablet of treatment R (Glucophage 500 mg tablet) given with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 ante meridiem (am) and 8:30 am on Day 1 (dosing day) of each study period.
160062|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
160063|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
160064|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
160117|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160225|NCT01710332|B3|Baseline|Total|Total of all reporting groups
160065|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
160066|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
160067|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
160068|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
160069|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
160070|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
160071|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
160072|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
160073|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
160118|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160074|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
160075|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
160076|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
160077|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
160078|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
160079|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
160080|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
160081|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
160082|NCT01710527|E2|Reported Event|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 h after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 24 h post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
160119|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160083|NCT01710527|E1|Reported Event|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 h after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 24 h post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
160084|NCT01710514|B3|Baseline|Total|Total of all reporting groups
160085|NCT01710514|B2|Baseline|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
160086|NCT01710514|B1|Baseline|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
160087|NCT01710514|P2|Participant Flow|FE 999913 100 mg TID|"FE 999913 100 mg vaginal tablet TID~FE 999913 vaginal tablet"
160088|NCT01710514|P1|Participant Flow|FE 999913 100 mg BID|"FE 999913 100 mg vaginal tablet BID~FE 999913 vaginal tablet"
160089|NCT01710514|O3|Outcome|FE 999913 Total|Data pooled from BID and TID groups
160090|NCT01710514|O2|Outcome|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
160091|NCT01710514|O1|Outcome|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
160092|NCT01710514|O3|Outcome|FE 999913 Total|Data pooled from BID and TID groups
160093|NCT01710514|O2|Outcome|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
160094|NCT01710514|O1|Outcome|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
160095|NCT01710514|O3|Outcome|FE 999913 Total|Data pooled from BID and TID groups
160096|NCT01710514|O2|Outcome|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
160097|NCT01710514|O1|Outcome|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
160098|NCT01710514|O3|Outcome|FE 999913 Total|Data pooled from BID and TID groups
160099|NCT01710514|O2|Outcome|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
160100|NCT01710514|O1|Outcome|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
160101|NCT01710514|O1|Outcome|FE999913 000072 (BID/TID)|Data pooled from both BID and TID groups
160102|NCT01710514|E3|Reported Event|FE 999913 Total|Data pooled from BID and TID groups
160103|NCT01710514|E2|Reported Event|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
160104|NCT01710514|E1|Reported Event|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
160105|NCT01710501|B4|Baseline|Total|Total of all reporting groups
160106|NCT01710501|B3|Baseline|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160107|NCT01710501|B2|Baseline|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160108|NCT01710501|B1|Baseline|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160109|NCT01710501|P3|Participant Flow|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160110|NCT01710501|P2|Participant Flow|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160111|NCT01710501|P1|Participant Flow|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160112|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160113|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160114|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160115|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160116|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160222|NCT01710345|E3|Reported Event|Placebo NanoTab|Placebo NanoTab as needed every 60 minutes for 12 hours
160120|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160121|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160122|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160123|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160124|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160125|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160126|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160127|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160128|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160129|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160130|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160131|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160132|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160133|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160134|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160135|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160136|NCT01710501|E3|Reported Event|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160137|NCT01710501|E2|Reported Event|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160138|NCT01710501|E1|Reported Event|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
160139|NCT01710358|B4|Baseline|Total|Total of all reporting groups
160223|NCT01710345|E2|Reported Event|Sufentanil NanoTab 30 mcg|Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
160140|NCT01710358|B3|Baseline|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.~Participants continued to take background MTX) therapy throughout study."
160141|NCT01710358|B2|Baseline|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160142|NCT01710358|B1|Baseline|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50.~At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.~Participants continued to take background methotrexate (MTX) therapy throughout study."
160143|NCT01710358|P3|Participant Flow|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160144|NCT01710358|P2|Participant Flow|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160145|NCT01710358|P1|Participant Flow|Placebo|"Placebo administered orally (PO) once daily (QD) through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50.~At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.~Participants continued to take background methotrexate (MTX) therapy throughout study."
160146|NCT01710358|O1|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52
160147|NCT01710358|O1|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52
160148|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160149|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study.~Baricitinib: Administered orally"
160150|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.~At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160151|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160152|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study.~Baricitinib: Administered orally"
160153|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.~At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160154|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160155|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160156|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.~At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160157|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160158|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
173053|NCT01665170|E2|Reported Event|Verum|Verum arm - Pascoflair 425mg
160159|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.~At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160160|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160161|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160162|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.~At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160163|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160164|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160165|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.~At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160166|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160167|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160168|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.~At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160169|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160170|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160171|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.~At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160172|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160173|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160174|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.~At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160175|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160176|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160177|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.~At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160178|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160179|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study.~Baricitinib: Administered orally"
160180|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.~At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160181|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160182|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160183|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.~At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160184|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160185|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160186|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.~At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160187|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160188|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160189|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.~At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160190|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160191|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160192|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.~At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160193|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 52.~Participants will continue to take background MTX therapy throughout study."
160194|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib will continue to receive baricitinib 4 mg administered orally once daily through Week 52.~Participants will continue to take background MTX therapy throughout study."
160195|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.~At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160196|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who are were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.~Participants will continued to take background MTX therapy throughout study."
160197|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160198|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.~At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160199|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160200|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160201|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.~At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.~Participants continued to take background MTX therapy throughout study."
160202|NCT01710358|E10|Reported Event|Adalimumab Follow-up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
160203|NCT01710358|E9|Reported Event|Baricitinib Follow-up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug. Participants who were rescued or switched to Baricitinib 4 mg.
160204|NCT01710358|E8|Reported Event|Placebo Follow-up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
160205|NCT01710358|E7|Reported Event|Rescue|Baricitinib 4 mg administered PO QD through Week 52 (Week 16-52).
160206|NCT01710358|E6|Reported Event|Adalimumab Treatment B|"Adalimumab Treatment B (week 24-52).~Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52."
160207|NCT01710358|E5|Reported Event|BaricitinibTreatment B|"Baricitinib Treatment B (week 24-52).~Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52."
160208|NCT01710358|E4|Reported Event|Placebo Treatment B|"Placebo Treatment B (week 24-52).~Placebo administered orally (PO) once daily (QD) through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50.~At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52."
160209|NCT01710358|E3|Reported Event|Adalimumab Treatment A|"Adalimumab Treatment A (week 0-24).~Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52."
160210|NCT01710358|E2|Reported Event|Baricitinib Treatment A|"Baricitinib Treatment A (week 0-24).~Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.~Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52."
160211|NCT01710358|E1|Reported Event|Placebo Treatment A|"Placebo Treatment A (week 0-24).~Placebo administered orally (PO) once daily (QD) through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50.~At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52.~Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52."
160212|NCT01710345|B4|Baseline|Total|Total of all reporting groups
160213|NCT01710345|B3|Baseline|Placebo NanoTab|Placebo NanoTab as needed every 60 minutes for 12 hours
160214|NCT01710345|B2|Baseline|Sufentanil NanoTab 30 mcg|Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
160215|NCT01710345|B1|Baseline|Sufentanil NanoTab 20 mcg|Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
160216|NCT01710345|P3|Participant Flow|Placebo NanoTab|Placebo NanoTab as needed every 60 minutes for 12 hours
160217|NCT01710345|P2|Participant Flow|Sufentanil NanoTab 30 mcg|Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
160218|NCT01710345|P1|Participant Flow|Sufentanil NanoTab 20 mcg|Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
160219|NCT01710345|O3|Outcome|Placebo NanoTab|Placebo NanoTab as needed every 60 minutes for 12 hours
160220|NCT01710345|O2|Outcome|Sufentanil NanoTab 30 mcg|Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
160221|NCT01710345|O1|Outcome|Sufentanil NanoTab 20 mcg|Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
173054|NCT01665170|E1|Reported Event|Placebo|Placebo arm
160226|NCT01710332|B2|Baseline|Intravitreal Aflibercept Injection (x6)|"2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).~Intravitreal Aflibercept Injection: GROUP A – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).~GROUP B – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
160227|NCT01710332|B1|Baseline|Intravitreal Aflibercept Injection (x4)|"2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).~Intravitreal Aflibercept Injection: GROUP A – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).~GROUP B – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
160228|NCT01710332|P2|Participant Flow|Intravitreal Aflibercept Injection (x6)|"2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).~Intravitreal Aflibercept Injection: GROUP A – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).~GROUP B – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
160229|NCT01710332|P1|Participant Flow|Intravitreal Aflibercept Injection (x4)|"2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).~Intravitreal Aflibercept Injection: GROUP A – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).~GROUP B – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
160230|NCT01710332|O2|Outcome|Intravitreal Aflibercept Injection (x6)|"2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).~GROUP B – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
160231|NCT01710332|O1|Outcome|Intravitreal Aflibercept Injection (x4)|"2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).~Intravitreal Aflibercept Injection: GROUP A – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total)."
160232|NCT01710332|O2|Outcome|Intravitreal Aflibercept Injection (x6)|"2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).~GROUP B – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
160233|NCT01710332|O1|Outcome|Intravitreal Aflibercept Injection (x4)|"2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).~Intravitreal Aflibercept Injection: GROUP A – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total)."
160234|NCT01710332|E2|Reported Event|Intravitreal Aflibercept Injection (x6)|"2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).~GROUP B – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
160235|NCT01710332|E1|Reported Event|Intravitreal Aflibercept Injection (x4)|"2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).~Intravitreal Aflibercept Injection: GROUP A – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total)."
160236|NCT01710254|B1|Baseline|Regadenoson MRI|Participants with atrial fibrillation receiving regadenoson stress MRI
160237|NCT01710254|P1|Participant Flow|Regadenoson MRI|Participants with atrial fibrillation receiving regadenoson stress MRI
160238|NCT01710254|O1|Outcome|Regadenoson MRI|Participants with atrial fibrillation receiving regadenoson stress MRI
160239|NCT01710254|O1|Outcome|Regadenoson MRI|Participants with atrial fibrillation receiving regadenoson stress MRI
160240|NCT01710254|O1|Outcome|Regadenoson MRI|Participants with atrial fibrillation receiving regadenoson stress MRI
160241|NCT01710254|E1|Reported Event|Regadenoson MRI|Participants with atrial fibrillation receiving regadenoson stress MRI
160242|NCT01710046|B3|Baseline|Total|Total of all reporting groups
160243|NCT01710046|B2|Baseline|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
160244|NCT01710046|B1|Baseline|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
160245|NCT01710046|P2|Participant Flow|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
160246|NCT01710046|P1|Participant Flow|Tofacitinib 10 Milligrams (mg) Twice Daily (BID)|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
160247|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
160248|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
160249|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
160250|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
160251|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
160252|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
160253|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
160254|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
160255|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
160256|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
160257|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
160258|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
160259|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
160260|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
160261|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
160262|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
160263|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
160264|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
162033|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
160265|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
160266|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
160267|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
160268|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
160269|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
160270|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
160271|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
160272|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
160273|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
160274|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
160275|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
160276|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
160277|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
160278|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
160279|NCT01710046|E2|Reported Event|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
160280|NCT01710046|E1|Reported Event|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
160281|NCT01710033|B5|Baseline|Total|Total of all reporting groups
160282|NCT01710033|B4|Baseline|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
160283|NCT01710033|B3|Baseline|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160284|NCT01710033|B2|Baseline|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
160285|NCT01710033|B1|Baseline|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160286|NCT01710033|P5|Participant Flow|CP-690,550 30 mg, Stage 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 2.
160287|NCT01710033|P4|Participant Flow|CP-690,550 30 mg, Stage 1|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1.
160288|NCT01710033|P3|Participant Flow|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160289|NCT01710033|P2|Participant Flow|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
160290|NCT01710033|P1|Participant Flow|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (mycophenolate mofetil [MMF] with or without calcineurin inhibitor [cyclosporine {CsA} or tacrolimus {TAC}]) as per local clinical practice in Stage 1.
160291|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160292|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160293|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160294|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160295|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160296|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160403|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
160297|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160298|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160299|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160300|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160301|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160302|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
160303|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160304|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160305|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
160306|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160307|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160308|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
160309|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160310|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160311|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
160312|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160313|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160314|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
160315|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160316|NCT01710033|O4|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
160317|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160318|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
160404|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
160319|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160320|NCT01710033|O4|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
160321|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160322|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
160323|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160324|NCT01710033|O4|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
160325|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160326|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
160327|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160328|NCT01710033|O4|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
160329|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160330|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
160331|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160332|NCT01710033|O4|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
160333|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160334|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
160335|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160336|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
160337|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160338|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
160339|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
160340|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160341|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
160342|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
160343|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160344|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
160345|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
160346|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160347|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
160348|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
160349|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160350|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
160351|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
160352|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160353|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
160354|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
160355|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160356|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
160357|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
160358|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160359|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
160360|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
160361|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160362|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
160363|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
160364|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160482|NCT01709786|O1|Outcome|Radical-7 Hemoglobin|Radical-7 hemoglobin measurement
160365|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
160366|NCT01710033|E4|Reported Event|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
160367|NCT01710033|E3|Reported Event|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160368|NCT01710033|E2|Reported Event|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
160369|NCT01710033|E1|Reported Event|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
160370|NCT01710020|B1|Baseline|Entire Study Population|Includes all participants enrolled in the study.
160371|NCT01710020|P1|Participant Flow|CP-690,550 (10 mg OPC)|Single oral dose of CP-690,550 10 milligram (mg) oral powder for constitution (OPC) 1 to 2 hours (hrs) post-hemodialysis in Period 1 followed by single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2. A washout period of at least 14 days was maintained between each intervention period.
160372|NCT01710020|O1|Outcome|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
160373|NCT01710020|O1|Outcome|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
160374|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
160375|NCT01710020|O1|Outcome|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
160376|NCT01710020|O1|Outcome|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
160377|NCT01710020|O1|Outcome|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
160378|NCT01710020|O1|Outcome|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
160379|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
160380|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
160381|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
160382|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
160383|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
160384|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
160385|NCT01710020|E2|Reported Event|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
160386|NCT01710020|E1|Reported Event|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
160387|NCT01709903|B3|Baseline|Total|Total of all reporting groups
160388|NCT01709903|B2|Baseline|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
160389|NCT01709903|B1|Baseline|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
160390|NCT01709903|P2|Participant Flow|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
160391|NCT01709903|P1|Participant Flow|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
160392|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
160393|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
160394|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
160395|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
160396|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
160397|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
160398|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
160399|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
160400|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
160401|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
160402|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
160405|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
160406|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
160407|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
160408|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
160409|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
160410|NCT01709903|E2|Reported Event|Salmeterol/Fluticasone 50mcg/500mcg|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
160411|NCT01709903|E1|Reported Event|QVA149 110mcg/50mcg|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
160412|NCT01709864|B3|Baseline|Total|Total of all reporting groups
160413|NCT01709864|B2|Baseline|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
160414|NCT01709864|B1|Baseline|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
160415|NCT01709864|P2|Participant Flow|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
160416|NCT01709864|P1|Participant Flow|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
160417|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
160418|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
160419|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
160420|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
160421|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
160422|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
160423|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
160424|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
160425|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
160426|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
160427|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
160428|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
160429|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
160430|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
160431|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
160432|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
160433|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
160434|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
160435|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
160436|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
160437|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
160438|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
160439|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
160440|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
160441|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
160442|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
160443|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
160444|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
160445|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
160446|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
160447|NCT01709864|E2|Reported Event|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
160448|NCT01709864|E1|Reported Event|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
160449|NCT01709799|B4|Baseline|Total|Total of all reporting groups
160450|NCT01709799|B3|Baseline|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
160483|NCT01709786|E1|Reported Event|Radical-7 vs. CBC|All patients: Difference between Radical-Y hemoglobin measurement and CBC hemoglobin measurement
160484|NCT01709708|B3|Baseline|Total|Total of all reporting groups
160485|NCT01709708|B2|Baseline|Saline|Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
160451|NCT01709799|B2|Baseline|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Participants also received cognitive training every fourth week. See Cognitive Training arm for description."
160452|NCT01709799|B1|Baseline|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR.~Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Participants also received cognitive training every fourth week. See Cognitive Training arm for description."
160453|NCT01709799|P3|Participant Flow|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
160454|NCT01709799|P2|Participant Flow|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details."
160455|NCT01709799|P1|Participant Flow|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR.~Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details."
160456|NCT01709799|O3|Outcome|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
160457|NCT01709799|O2|Outcome|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
160458|NCT01709799|O1|Outcome|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
160459|NCT01709799|O3|Outcome|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
160486|NCT01709708|B1|Baseline|Marcaine|"Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)~Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
160487|NCT01709708|P2|Participant Flow|Saline|Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
160460|NCT01709799|O2|Outcome|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
160461|NCT01709799|O1|Outcome|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
160462|NCT01709799|O3|Outcome|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
160463|NCT01709799|O2|Outcome|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
160464|NCT01709799|O1|Outcome|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
160465|NCT01709799|O3|Outcome|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
160466|NCT01709799|O2|Outcome|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
160467|NCT01709799|O1|Outcome|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
160468|NCT01709799|O3|Outcome|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
160488|NCT01709708|P1|Participant Flow|Marcaine|"Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)~Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
162034|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
160469|NCT01709799|O2|Outcome|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
160470|NCT01709799|O1|Outcome|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
160471|NCT01709799|O3|Outcome|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
160472|NCT01709799|O2|Outcome|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
160473|NCT01709799|O1|Outcome|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
160474|NCT01709799|E3|Reported Event|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
160475|NCT01709799|E2|Reported Event|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details."
160476|NCT01709799|E1|Reported Event|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR.~Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details."
160477|NCT01709786|B1|Baseline|Patients With Suspected Hemorrhage|There is a single group of patients in this study -- those with suspected hemorrhage who satisfy the inclusion and exclusion criteria. The same set of measurements will be take from each patients and those measurements will be compared with one another to determine accuracy.
160478|NCT01709786|P1|Participant Flow|Patients With Suspected Hemorrhage|There is a single group of patients in this study -- those with suspected hemorrhage who satisfy the inclusion and exclusion criteria. The same set of measurements will be take from each patients and those measurements will be compared with one another to determine accuracy.
160479|NCT01709786|O2|Outcome|CBC Hemoglobin|CBC hemoglobin measurement
160480|NCT01709786|O1|Outcome|iSTAT Hemoglobin|iSTAT hemoglobin measurement
160481|NCT01709786|O2|Outcome|CBC Hemoglobin|CBC hemoglobin measurement
160489|NCT01709708|O2|Outcome|Saline|Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
160490|NCT01709708|O1|Outcome|Marcaine|"Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)~Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
160491|NCT01709708|O2|Outcome|Saline|Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
160492|NCT01709708|O1|Outcome|Marcaine|"Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)~Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
160493|NCT01709708|O2|Outcome|Saline|Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
160494|NCT01709708|O1|Outcome|Marcaine|"Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)~Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
160495|NCT01709708|O2|Outcome|Saline|Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
160496|NCT01709708|O1|Outcome|Marcaine|"Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)~Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
160497|NCT01709708|O2|Outcome|Saline|"Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.~Saline: Saline"
160498|NCT01709708|O1|Outcome|Marcaine|"Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)~Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
160499|NCT01709708|O2|Outcome|Saline|Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
160500|NCT01709708|O1|Outcome|Marcaine|"Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)~Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
160501|NCT01709708|O2|Outcome|Saline|"Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.~Saline: Saline"
160502|NCT01709708|O1|Outcome|Marcaine|"Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)~Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
160503|NCT01709708|O2|Outcome|Saline|"Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.~Saline: Saline"
160504|NCT01709708|O1|Outcome|Marcaine|"Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)~Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
160505|NCT01709708|O2|Outcome|Saline|Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
160506|NCT01709708|O1|Outcome|Marcaine|"Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)~Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
160507|NCT01709708|E2|Reported Event|Saline|Saline (Group B) will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
160508|NCT01709708|E1|Reported Event|Marcaine|"Marcaine (Group A) will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)~Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
160509|NCT01709695|B3|Baseline|Total|Total of all reporting groups
160510|NCT01709695|B2|Baseline|Placebo Group|Flexible dose titration of placebo
160511|NCT01709695|B1|Baseline|Guanfacine Hydrochloride XR|Flexible dose titration of guanfacine extended release - titrated in doses from 1 - 4 mg once daily
160512|NCT01709695|P2|Participant Flow|Placebo Group|Flexible dose titration of placebo
160513|NCT01709695|P1|Participant Flow|Guanfacine Hydrochloride XR|Flexible dose titration of guanfacine extended release - titrated in doses from 1 - 4 mg once daily
160514|NCT01709695|O2|Outcome|Placebo Group|Flexible dose titration of placebo
160515|NCT01709695|O1|Outcome|Guanfacine Hydrochloride XR|Flexible dose titration of guanfacine extended release - titrated in doses from 1 - 4 mg once daily
160516|NCT01709695|O2|Outcome|Placebo Group|Flexible dose titration of placebo
160517|NCT01709695|O1|Outcome|Guanfacine Hydrochloride XR|Flexible dose titration of guanfacine extended release - titrated in doses from 1 - 4 mg once daily
160518|NCT01709695|O2|Outcome|Placebo Group|Flexible dose titration of placebo
160519|NCT01709695|O1|Outcome|Guanfacine Hydrochloride XR|Flexible dose titration of guanfacine extended release - titrated in doses from 1 - 4 mg once daily
160520|NCT01709695|O2|Outcome|Placebo Group|Flexible dose titration of placebo
160521|NCT01709695|O1|Outcome|Guanfacine Hydrochloride XR|Flexible dose titration of guanfacine extended release - titrated in doses from 1 - 4 mg once daily
160522|NCT01709695|O2|Outcome|Placebo Group|Flexible dose titration of placebo
160738|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160523|NCT01709695|O1|Outcome|Guanfacine Hydrochloride XR|Flexible dose titration of guanfacine extended release - titrated in doses from 1 - 4 mg once daily
160524|NCT01709695|O2|Outcome|Placebo Group|Flexible dose titration of placebo
160525|NCT01709695|O1|Outcome|Guanfacine Hydrochloride XR|Flexible dose titration of guanfacine extended release - titrated in doses from 1 - 4 mg once daily
160526|NCT01709695|O2|Outcome|Placebo Group|Flexible dose titration of placebo
160527|NCT01709695|O1|Outcome|Guanfacine Hydrochloride XR|Flexible dose titration of guanfacine extended release - titrated in doses from 1 - 4 mg once daily
160528|NCT01709695|O2|Outcome|Placebo Group|Flexible dose titration of placebo
160529|NCT01709695|O1|Outcome|Guanfacine Hydrochloride XR|Flexible dose titration of guanfacine extended release - titrated in doses from 1 - 4 mg once daily
160530|NCT01709695|O2|Outcome|Placebo Group|Flexible dose titration of placebo
160531|NCT01709695|O1|Outcome|Guanfacine Hydrochloride XR|Flexible dose titration of guanfacine extended release - titrated in doses from 1 - 4 mg once daily
160532|NCT01709695|E2|Reported Event|Placebo Group|Flexible dose titration of placebo
160533|NCT01709695|E1|Reported Event|Guanfacine Hydrochloride XR|Flexible dose titration of guanfacine extended release - titrated in doses from 1 - 4 mg once daily
160534|NCT01709578|B4|Baseline|Total|Total of all reporting groups
160535|NCT01709578|B3|Baseline|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160536|NCT01709578|B2|Baseline|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160537|NCT01709578|B1|Baseline|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160538|NCT01709578|P3|Participant Flow|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160539|NCT01709578|P2|Participant Flow|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160540|NCT01709578|P1|Participant Flow|Placebo q2w|Placebo matched to sarilumab subcutaneous (SC) injection once every 2 weeks (q2w) was added to one or a combination of the nonbiologic disease modifying antirheumatic drug (DMARD) for 24 weeks.
160541|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160542|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160543|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160544|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160545|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160546|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160547|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160548|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160549|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160550|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160551|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160552|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160553|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160554|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160555|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160556|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160557|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160558|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160559|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160560|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160561|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160562|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160563|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160564|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160565|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160566|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160567|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160568|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160569|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160570|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160571|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160572|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160573|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160574|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160575|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160576|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160577|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160578|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160579|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160580|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160581|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160582|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160583|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160584|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160585|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160586|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160587|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160588|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160589|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160590|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160591|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160592|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160593|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160594|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160595|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160596|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160597|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160598|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160599|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160600|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160601|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160602|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160603|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160604|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160605|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160606|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160607|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160608|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160609|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160610|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160611|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160612|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160613|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160614|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160615|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160616|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160617|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160618|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160619|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160620|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160621|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160622|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160623|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160624|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160625|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160626|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160627|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160628|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160629|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160630|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160631|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160632|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160633|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160634|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160635|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160636|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160637|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160638|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160639|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160640|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160641|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160642|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160643|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160644|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160645|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160646|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160647|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160648|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160649|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160650|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160651|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160652|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160653|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160654|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160655|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160656|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160657|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160658|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160659|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160660|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160661|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160662|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160663|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160664|NCT01709578|E3|Reported Event|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160665|NCT01709578|E2|Reported Event|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160666|NCT01709578|E1|Reported Event|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
160667|NCT01709513|B4|Baseline|Total|Total of all reporting groups
160668|NCT01709513|B3|Baseline|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160669|NCT01709513|B2|Baseline|Ezetimibe (Active Comparator)|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160670|NCT01709513|B1|Baseline|Atorvastatin (Statin Rechallenge Arm)|Atorvastatin 20 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable lipid-modifying therapy (LMT).
160671|NCT01709513|P3|Participant Flow|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160672|NCT01709513|P2|Participant Flow|Ezetimibe (Active Comparator)|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160673|NCT01709513|P1|Participant Flow|Atorvastatin (Statin Rechallenge Arm)|Atorvastatin 20 mg over-encapsulated tablets orally once daily (QD) for 24 weeks and placebo (for alirocumab) subcutaneous (SC) injection every two weeks (Q2W) for 24 weeks added to stable LMT.
160674|NCT01709513|O3|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160675|NCT01709513|O2|Outcome|Ezetimibe (Active Comparator)|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160676|NCT01709513|O1|Outcome|Atorvastatin (Statin Rechallenge Arm)|Atorvastatin 20 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160677|NCT01709513|O3|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160678|NCT01709513|O2|Outcome|Ezetimibe (Active Comparator)|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160679|NCT01709513|O1|Outcome|Atorvastatin (Statin Rechallenge Arm)|Atorvastatin 20 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160680|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160681|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160682|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160683|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160684|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160776|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160685|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160686|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160687|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160688|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160689|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160690|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160691|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160692|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160693|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160694|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160695|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160696|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160697|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160698|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160699|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160700|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160701|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160702|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160703|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160704|NCT01709513|O2|Outcome|Alirocumab 75/ up to 150|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160705|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160706|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160707|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160708|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160709|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160810|NCT01709409|B3|Baseline|Total|Total of all reporting groups
161280|NCT01708057|E1|Reported Event|50ug AZD8683|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
160710|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160711|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160712|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160713|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160714|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160715|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160716|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160717|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160718|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160719|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160720|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160721|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160722|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160723|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160724|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160725|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160726|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160727|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
160728|NCT01709513|E3|Reported Event|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 22 weeks and placebo for atorvastatin/ezetimibe over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-­C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
160729|NCT01709513|E2|Reported Event|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo for alirocumab SC injection Q2W for 22 weeks added to stable LMT.
160730|NCT01709513|E1|Reported Event|Atorvastatin|Atorvastatin 20 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 22 weeks added to stable LMT.
160731|NCT01709500|B3|Baseline|Total|Total of all reporting groups
160732|NCT01709500|B2|Baseline|Placebo|Placebo matched to alirocumab SC injection for 78­-week treatment duration.
160733|NCT01709500|B1|Baseline|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160734|NCT01709500|P2|Participant Flow|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160735|NCT01709500|P1|Participant Flow|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection every two weeks (Q2W) added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160736|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160737|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160984|NCT01708967|B3|Baseline|Total|Total of all reporting groups
160739|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160740|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160741|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160742|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160743|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160744|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160745|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160746|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160747|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160748|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160749|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160750|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160751|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160752|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160753|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160754|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160755|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160756|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160757|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160758|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160759|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160760|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160761|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160762|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160763|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160764|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160765|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160766|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160767|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160768|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160769|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160770|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160771|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160772|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160773|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160774|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160775|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
161281|NCT01707667|B3|Baseline|Total|Total of all reporting groups
160777|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160778|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160779|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160780|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160781|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160782|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160783|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160784|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160785|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160786|NCT01709500|E2|Reported Event|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
160787|NCT01709500|E1|Reported Event|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection every two weeks (Q2W) added to stable dose of statin with or without LMT for 76 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
160788|NCT01709474|B3|Baseline|Total|Total of all reporting groups
160789|NCT01709474|B2|Baseline|Vitamin D3 400 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units [IU] daily).
160790|NCT01709474|B1|Baseline|Vitamin D3 6000 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units [IU] daily).
160791|NCT01709474|P2|Participant Flow|Vitamin D3 400 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units [IU] daily).
160792|NCT01709474|P1|Participant Flow|Vitamin D3 6000 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units [IU] daily).
160793|NCT01709474|O2|Outcome|Vitamin D3 400 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units [IU] daily).
160794|NCT01709474|O1|Outcome|Vitamin D3 6000 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units [IU] daily).
160795|NCT01709474|O2|Outcome|Vitamin D3 400 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units [IU] daily).
160796|NCT01709474|O1|Outcome|Vitamin D3 6000 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units [IU] daily).
160797|NCT01709474|E2|Reported Event|Vitamin D3 400 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units [IU] daily).
160798|NCT01709474|E1|Reported Event|Vitamin D3 6000 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units [IU] daily).
160799|NCT01709422|B3|Baseline|Total|Total of all reporting groups
160800|NCT01709422|B2|Baseline|Midazolam and Meperidine|The initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes
160801|NCT01709422|B1|Baseline|Propofol,Midazolam and Meperidine|The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second.the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg.
160802|NCT01709422|P2|Participant Flow|Conventional|The initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes
160803|NCT01709422|P1|Participant Flow|Propofol|The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second.the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg.
160804|NCT01709422|O2|Outcome|Midazolam and Meperidine|the initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3minutes to maintain the desired level of sedation (moderate to deep sedation ) without maximum limit.
160805|NCT01709422|O1|Outcome|Propofol,Midazolam and Meperidine|the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg. The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second to maintained the desired level of sedation (moderate to deep sedation ) without maximum limit
160806|NCT01709422|O2|Outcome|Midazolam and Meperidine|the initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes to maintain the desired level of sedation(moderate to deep sedation ) without maximum limit.
160807|NCT01709422|O1|Outcome|Propofol,Midazolam and Meperidine|the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg. The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second to maintained the desired level of sedation(moderate to deep sedation ) without maximum limit.
160808|NCT01709422|E2|Reported Event|Midazolam and Meperidine|The initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes
160809|NCT01709422|E1|Reported Event|Propofol,Midazolam and Meperidine|The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second.the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg.
160811|NCT01709409|B2|Baseline|BLES (Group 2)|"Surfactant(BLES in this arm) is given for treatment of RDS after the diagnosis has been made by the Neonatologist. For BLES the recommended dose is 5 ml/kg. given by endotracheal method. There is a maximum of 3 doses in the study.~BLES-group 2: Maximum of 3 doses are administered to infants with RDS"
160812|NCT01709409|B1|Baseline|Curosurf (Group 1)|"Surfactant(Curosurf in this arm) is given for treatment of RDS after the diagnosis has been made by the Neonatologist. The treatment dose for Curosurf® is 2.5 ml/kg (200mg/kg) for the first dose and 1.25 ml/kg (100mg/kg) for repeat doses, given by endotracheal method. There is a maximum of 3 doses in the study.~Curosurf-Group1: Maximum of 3 doses are administered to infants diagnosed with RDS."
160813|NCT01709409|P2|Participant Flow|BLES (Group 2)|Surfactant(BLES in this arm) was given for treatment of established RDS. The treatment dose for BLES was 5 ml/kg. given by endotracheal method. There was a maximum of 3 doses in the study.
160814|NCT01709409|P1|Participant Flow|Curosurf (Group 1)|Surfactant(Curosurf in this arm) was given for treatment of established RDS. The treatment dose for Curosurf® was 2.5 ml/kg (200mg/kg) for the first dose and 1.25 ml/kg (100mg/kg) for repeat doses, given by endotracheal method. There was a maximum of 3 doses in the study.
160815|NCT01709409|O2|Outcome|BLES (Group 2)|Surfactant(BLES in this arm) was given for treatment of established RDS. The treatment dose for BLES was 5 ml/kg. given by endotracheal method. There was a maximum of 3 doses in the study.
160816|NCT01709409|O1|Outcome|Curosurf (Group 1)|Surfactant(Curosurf in this arm) was given for treatment of established RDS. The treatment dose for Curosurf® was 2.5 ml/kg (200mg/kg) for the first dose and 1.25 ml/kg (100mg/kg) for repeat doses, given by endotracheal method. There was a maximum of 3 doses in the study.
160817|NCT01709409|E2|Reported Event|BLES (Group 2)|Surfactant(BLES in this arm) was given for treatment of established RDS. The treatment dose for BLES was 5 ml/kg. given by endotracheal method. There was a maximum of 3 doses in the study.
160818|NCT01709409|E1|Reported Event|Curosurf (Group 1)|Surfactant(Curosurf in this arm) was given for treatment of established RDS. The treatment dose for Curosurf® was 2.5 ml/kg (200mg/kg) for the first dose and 1.25 ml/kg (100mg/kg) for repeat doses, given by endotracheal method. There was a maximum of 3 doses in the study.
160819|NCT01709383|B3|Baseline|Total|Total of all reporting groups
160820|NCT01709383|B2|Baseline|Sham Stimulation|Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
160821|NCT01709383|B1|Baseline|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
160822|NCT01709383|P2|Participant Flow|Sham Stimulation|Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
160823|NCT01709383|P1|Participant Flow|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
160824|NCT01709383|O2|Outcome|Sham Stimulation|Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
160825|NCT01709383|O1|Outcome|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
160826|NCT01709383|O2|Outcome|Sham Stimulation|Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
160827|NCT01709383|O1|Outcome|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
160828|NCT01709383|O2|Outcome|Sham Stimulation|Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
160829|NCT01709383|O1|Outcome|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
160830|NCT01709383|O2|Outcome|Sham Stimulation|Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
160831|NCT01709383|O1|Outcome|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
160832|NCT01709383|O2|Outcome|Sham Stimulation|"Sham tDCS was applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.~Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period."
160833|NCT01709383|O1|Outcome|Transcranial Direct Current Stimulation|"TDCS was applied bilaterally, with the anodal electrode on the left temple and cathodal electrode on the right. TDCS was applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period~Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period."
160834|NCT01709383|O2|Outcome|Sham Stimulation|Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
160835|NCT01709383|O1|Outcome|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
160836|NCT01709383|O2|Outcome|Sham Stimulation|Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
160837|NCT01709383|O1|Outcome|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
160838|NCT01709383|E2|Reported Event|Sham Stimulation|Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
160839|NCT01709383|E1|Reported Event|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
160840|NCT01709331|B1|Baseline|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
160841|NCT01709331|P1|Participant Flow|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly subcutaneous (SC) injections of human chorionic gonadotropin (hCG) 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
160842|NCT01709331|O1|Outcome|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
160843|NCT01709331|O1|Outcome|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
160844|NCT01709331|O1|Outcome|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
160845|NCT01709331|E1|Reported Event|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
160846|NCT01709305|B1|Baseline|Overall Study|During Phase 1, participants received sitagliptin 100 mg + metformin (Week 0 through Week 20).
160847|NCT01709305|P5|Participant Flow|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combinatino therapy for 24 weeks (Week 20 through Week 44). There were 554 participants randomized to this arm in Phase 2.
160848|NCT01709305|P4|Participant Flow|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 556 participants randomized to this arm in Phase 2.
160849|NCT01709305|P3|Participant Flow|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 550 participants randomized to this arm in Phase 2.
160850|NCT01709305|P2|Participant Flow|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 552 participants randomized to this arm in Phase 2.
160851|NCT01709305|P1|Participant Flow|Phase 1: Sitagliptin + Metformin|During Phase 1, participants received sitagliptin 100 mg + metformin (Week 0 through Week 20). There were 5570 participants enrolled in Phase 1.
160852|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160853|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160854|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160855|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
161168|NCT01708213|O1|Outcome|Dermal Filler - Aline HA|"Non-Randomized~Aline HA: Implantable dermal filler"
160856|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160857|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160858|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160859|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160860|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160861|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160862|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160863|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160864|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160865|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160866|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160867|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160868|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160869|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160870|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160871|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160872|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 550 participants that contributed to the week 44 analysis.
160873|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 551 participants that contributed to the week 44 analysis.
160874|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 502 participants that contributed to the week 44 analysis.
160875|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 501 participants that contributed to the week 44 analysis.
160876|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160877|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160878|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160879|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160880|NCT01709305|E5|Reported Event|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160881|NCT01709305|E4|Reported Event|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160882|NCT01709305|E3|Reported Event|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160883|NCT01709305|E2|Reported Event|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
160884|NCT01709305|E1|Reported Event|Phase 1: Sitagliptin + Metformin|During Phase 1, participants received sitagliptin 100 mg + metformin for 20 weeks (Week 0 through Week 20).
160885|NCT01709227|B3|Baseline|Total|Total of all reporting groups
160886|NCT01709227|B2|Baseline|Peritoneal Dialysis|Patients randomized to receive peritoneal dialysis
160887|NCT01709227|B1|Baseline|Furosemide|Patients randomized to receive furosemide
160888|NCT01709227|P2|Participant Flow|Peritoneal Dialysis|"Patients within the PD arm will begin PD with a standardized dialysis plan of 10ml/kg of 1.5% Dianeal™ with 1 hours cycles (5 minute fill, 45 minute dwell and 10 minute drain). Further PD management will be directed by CICU attending and Nephrology service~Peritoneal Dialysis: Patients within the PD arm will begin PD with a standardized dialysis plan of 10ml/kg of 1.5% Dianeal™ with 1 hours cycles (5 minute fill, 45 minute dwell and 10 minute drain). Further PD management and discontinuation will be directed by CICU attending and Nephrology service.~One potential outcome during use of a peritoneal dialysis catheter is the development of a Pleural Peritoneal communication. In this event, dialysis fluid is instilled in the peritoneum and then leaks into the pleural space through a defect in the diaphragm. This fluid is then drained out of a surgical chest tube. This impairs the ability to perform peritoneal dialysis and thus is a reason to not complete the randomized arm."
160889|NCT01709227|P1|Participant Flow|Furosemide|"Patients randomized to the furosemide arm will be given 1 mg/kg intravenously every 6 hours for 2 doses and then as directed by CICU attending to augment urine output. Patients within this arm who have urine output <1 ml/kg/hr over 16 hours after the first dose of Lasix will be considered poor responders. These patients may be started on PD if clinically indicated. Those who show good response (urine output >1 ml/kg/hr over subsequent 16 hours) will continue furosemide as needed to augment urine output. If they subsequently develop oliguria or fluid overload unresponsive to diuretic therapy, these patients may later be started on PD at discretion of CICU attending with consultation of nephrology service.~Furosemide: Patients randomized to the furosemide arm are given 1 mg/kg intravenously every 6 hours for 2 doses and then as directed by CICU attending to augment urine output. Patients within this arm who have urine output <1 ml/kg/hr over 16 hours after the first dose of Lasix"
160890|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to PD
160891|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
160892|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
160893|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
160894|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
160895|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
160896|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
160897|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
160898|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
160899|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
160900|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
160901|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
160902|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
160903|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
160904|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to PD
160905|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
160906|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
160907|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
160908|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
160909|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
160910|NCT01709227|E2|Reported Event|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
160911|NCT01709227|E1|Reported Event|Furosemide|Patients randomized to furosemide
160912|NCT01709162|B3|Baseline|Total|Total of all reporting groups
160913|NCT01709162|B2|Baseline|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
160914|NCT01709162|B1|Baseline|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
160915|NCT01709162|P2|Participant Flow|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
160916|NCT01709162|P1|Participant Flow|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
160917|NCT01709162|O2|Outcome|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
160918|NCT01709162|O1|Outcome|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
160919|NCT01709162|O2|Outcome|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
160920|NCT01709162|O1|Outcome|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
160921|NCT01709162|O2|Outcome|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
160922|NCT01709162|O1|Outcome|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
160923|NCT01709162|O2|Outcome|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
160924|NCT01709162|O1|Outcome|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
160925|NCT01709162|E2|Reported Event|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
173055|NCT01665157|B4|Baseline|Total|Total of all reporting groups
160926|NCT01709162|E1|Reported Event|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, by intravenous infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
160927|NCT01709136|B1|Baseline|Sirolimus|Sirolimus: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC , and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab. This phase can either be performed immediately after the 12-hour iothalamate GFR evaluation, or a few days later at the convenience of the subject.
160928|NCT01709136|P1|Participant Flow|Sirolimus|Sirolimus: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the Children's Hospital of Pittsburgh Pediatric Clinical and Translational Research Center (PCTRC) - See more at: http://www.chp.edu/research/our-facilities/pctrc, and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab. This phase can either be performed immediately after the 12-hour iothalamate Glomerular Filtration Rate (GFR) evaluation, or a few days later at the convenience of the subject.
160929|NCT01709136|O1|Outcome|Sirolimus|Sirolimus: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC , and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab.
160930|NCT01709136|O1|Outcome|Sirolimus|Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC, and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab.
160931|NCT01709136|O1|Outcome|Sirolimus|Sirolimus: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC , and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab..
160932|NCT01709136|O1|Outcome|Sirolimus|Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC , and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab.
160933|NCT01709136|E1|Reported Event|Sirolimus|Sirolimus: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC , and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab. This phase can either be performed immediately after the 12-hour iothalamate GFR evaluation, or a few days later at the convenience of the subject.
160934|NCT01709110|B3|Baseline|Total|Total of all reporting groups
160935|NCT01709110|B2|Baseline|Risedronate|"Risedronate 35 milligram administered orally once weekly for 24 months.~Placebo given by SC injection once daily for 24 months."
160936|NCT01709110|B1|Baseline|Teriparatide|"Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.~Placebo given orally once weekly for 24 months."
160937|NCT01709110|P2|Participant Flow|Risedronate|"Risedronate 35 milligram (mg) administered orally once weekly for 24 months.~Placebo given by SC injection once daily for 24 months."
160938|NCT01709110|P1|Participant Flow|Teriparatide|"Teriparatide 20 microgram (µg) administered by subcutaneous (SC) injection once daily for 24 months.~Placebo given orally once weekly for 24 months."
160939|NCT01709110|O2|Outcome|Risedronate|"Risedronate 35 milligram administered orally once weekly for 24 months.~Placebo given by SC injection once daily for 24 months."
160940|NCT01709110|O1|Outcome|Teriparatide|"Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.~Placebo given orally once weekly for 24 months."
160941|NCT01709110|O2|Outcome|Risedronate|"Risedronate 35 milligram administered orally once weekly for 24 months.~Placebo given by SC injection once daily for 24 months."
160942|NCT01709110|O1|Outcome|Teriparatide|"Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.~Placebo given orally once weekly for 24 months."
160943|NCT01709110|O2|Outcome|Risedronate|"Risedronate 35 milligram administered orally once weekly for 24 months.~Placebo given by SC injection once daily for 24 months."
160944|NCT01709110|O1|Outcome|Teriparatide|"Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.~Placebo given orally once weekly for 24 months."
160945|NCT01709110|O2|Outcome|Risedronate|"Risedronate 35 milligram administered orally once weekly for 24 months.~Placebo given by SC injection once daily for 24 months."
160946|NCT01709110|O1|Outcome|Teriparatide|"Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.~Placebo given orally once weekly for 24 months."
160947|NCT01709110|O2|Outcome|Risedronate|"Risedronate 35 milligram administered orally once weekly for 24 months.~Placebo given by SC injection once daily for 24 months."
160948|NCT01709110|O1|Outcome|Teriparatide|"Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.~Placebo given orally once weekly for 24 months."
160949|NCT01709110|O2|Outcome|Risedronate|"Risedronate 35 milligram administered orally once weekly for 24 months.~Placebo given by SC injection once daily for 24 months."
160950|NCT01709110|O1|Outcome|Teriparatide|"Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.~Placebo given orally once weekly for 24 months."
160951|NCT01709110|O2|Outcome|Risedronate|"Risedronate 35 milligram administered orally once weekly for 24 months.~Placebo given by SC injection once daily for 24 months."
160952|NCT01709110|O1|Outcome|Teriparatide|"Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.~Placebo given orally once weekly for 24 months."
160953|NCT01709110|O2|Outcome|Risedronate|"Risedronate 35 milligram administered orally once weekly for 24 months.~Placebo given by SC injection once daily for 24 months."
160954|NCT01709110|O1|Outcome|Teriparatide|"Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.~Placebo given orally once weekly for 24 months."
160955|NCT01709110|O2|Outcome|Risedronate|"Risedronate 35 milligram administered orally once weekly for 24 months.~Placebo given by SC injection once daily for 24 months."
160956|NCT01709110|O1|Outcome|Teriparatide|"Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.~Placebo given orally once weekly for 24 months."
160957|NCT01709110|O2|Outcome|Risedronate|"Risedronate 35 milligram administered orally once weekly for 24 months.~Placebo given by SC injection once daily for 24 months."
160958|NCT01709110|O1|Outcome|Teriparatide|"Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.~Placebo given orally once weekly for 24 months."
160959|NCT01709110|O2|Outcome|Risedronate|"Risedronate 35 milligram administered orally once weekly for 24 months.~Placebo given by SC injection once daily for 24 months."
160960|NCT01709110|O1|Outcome|Teriparatide|"Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.~Placebo given orally once weekly for 24 months."
160961|NCT01709110|O2|Outcome|Risedronate|"Risedronate 35 milligram administered orally once weekly for 24 months.~Placebo given by SC injection once daily for 24 months."
160962|NCT01709110|O1|Outcome|Teriparatide|"Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.~Placebo given orally once weekly for 24 months."
160963|NCT01709110|E2|Reported Event|Risedronate|"Risedronate 35 milligram administered orally once weekly for 24 months.~Placebo given by SC injection once daily for 24 months."
160964|NCT01709110|E1|Reported Event|Teriparatide|"Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.~Placebo given orally once weekly for 24 months."
160965|NCT01709084|B3|Baseline|Total|Total of all reporting groups
160966|NCT01709084|B2|Baseline|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
160967|NCT01709084|B1|Baseline|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
160968|NCT01709084|P2|Participant Flow|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
160969|NCT01709084|P1|Participant Flow|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
160970|NCT01709084|O2|Outcome|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
160971|NCT01709084|O1|Outcome|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
160972|NCT01709084|O2|Outcome|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
160973|NCT01709084|O1|Outcome|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
160974|NCT01709084|O2|Outcome|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
160975|NCT01709084|O1|Outcome|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
160976|NCT01709084|O2|Outcome|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
160977|NCT01709084|O1|Outcome|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
160978|NCT01709084|O2|Outcome|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
160979|NCT01709084|O1|Outcome|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
160980|NCT01709084|O2|Outcome|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
160981|NCT01709084|O1|Outcome|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
160982|NCT01709084|E2|Reported Event|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
160983|NCT01709084|E1|Reported Event|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
160985|NCT01708967|B2|Baseline|Catheter-insertion Method|"We explored success rate, side effects, and vital signs in patients with spray+catheter method.~Intervention: use both spray and catheter"
160986|NCT01708967|B1|Baseline|Catheter-free Method|"We explored success rate, side effects, and vital signs in patients with one-time spray method.~Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)"
160987|NCT01708967|P2|Participant Flow|Catheter-insertion Method|"We explored success rate, side effects, and vital signs in patients with spray+catheter method.~Intervention: use both spray and catheter~pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.~spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
160988|NCT01708967|P1|Participant Flow|Catheter-free Method|"We explored success rate, side effects, and vital signs in patients with one-time spray method.~Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)~pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.~spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
160989|NCT01708967|O2|Outcome|Catheter-insertion Method|"We explored success rate, side effects, and vital signs in patients with spray+catheter method.~Intervention: use both spray and catheter~pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.~spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
160990|NCT01708967|O1|Outcome|Catheter-free Method|"We explored success rate, side effects, and vital signs in patients with one-time spray method.~Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)~pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.~spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
160991|NCT01708967|E2|Reported Event|Catheter-insertion Method|"We explored success rate, side effects, and vital signs in patients with spray+catheter method.~Intervention: use both spray and catheter~pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.~spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
160992|NCT01708967|E1|Reported Event|Catheter-free Method|"We explored success rate, side effects, and vital signs in patients with one-time spray method.~Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)~pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.~spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
160993|NCT01708954|B4|Baseline|Total|Total of all reporting groups
160994|NCT01708954|B3|Baseline|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
160995|NCT01708954|B2|Baseline|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
160996|NCT01708954|B1|Baseline|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
160997|NCT01708954|P3|Participant Flow|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
160998|NCT01708954|P2|Participant Flow|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
160999|NCT01708954|P1|Participant Flow|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
161000|NCT01708954|O3|Outcome|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
161001|NCT01708954|O2|Outcome|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
161002|NCT01708954|O1|Outcome|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
161169|NCT01708213|O1|Outcome|Dermal Filler - Aline HA|"Non-Randomized~Aline HA: Implantable dermal filler"
161003|NCT01708954|O3|Outcome|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
161004|NCT01708954|O2|Outcome|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
161005|NCT01708954|O1|Outcome|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
161006|NCT01708954|O3|Outcome|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
161007|NCT01708954|O2|Outcome|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
161008|NCT01708954|O1|Outcome|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
161009|NCT01708954|O3|Outcome|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
161010|NCT01708954|O2|Outcome|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
161011|NCT01708954|O1|Outcome|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
161012|NCT01708954|O3|Outcome|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
161013|NCT01708954|O2|Outcome|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
161014|NCT01708954|O1|Outcome|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
161015|NCT01708954|E4|Reported Event|Arm Z (Erlotinib+Cabozantinib; Step 2)|Patients achieving disease progression in Arm A or Arm B may receive erlotinib 150mg and cabozantinib 40mg as patients in Arm C. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
161016|NCT01708954|E3|Reported Event|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
161017|NCT01708954|E2|Reported Event|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
161018|NCT01708954|E1|Reported Event|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
161019|NCT01708915|B5|Baseline|Total|Total of all reporting groups
161020|NCT01708915|B4|Baseline|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
161021|NCT01708915|B3|Baseline|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
161022|NCT01708915|B2|Baseline|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
161023|NCT01708915|B1|Baseline|Placebo|Patients treated with placebo ointment
161024|NCT01708915|P4|Participant Flow|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
161025|NCT01708915|P3|Participant Flow|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
161026|NCT01708915|P2|Participant Flow|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
161027|NCT01708915|P1|Participant Flow|Placebo|Patients treated with placebo ointment
161028|NCT01708915|O4|Outcome|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
161029|NCT01708915|O3|Outcome|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
161030|NCT01708915|O2|Outcome|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
161031|NCT01708915|O1|Outcome|Placebo|Patients treated with placebo ointment
161032|NCT01708915|O4|Outcome|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
161033|NCT01708915|O3|Outcome|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
161034|NCT01708915|O2|Outcome|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
161035|NCT01708915|O1|Outcome|Placebo|Patients treated with placebo ointment
161036|NCT01708915|O4|Outcome|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
161037|NCT01708915|O3|Outcome|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
161038|NCT01708915|O2|Outcome|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
161039|NCT01708915|O1|Outcome|Placebo|Patients treated with placebo ointment
161040|NCT01708915|O4|Outcome|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
161041|NCT01708915|O3|Outcome|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
161042|NCT01708915|O2|Outcome|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
161043|NCT01708915|O1|Outcome|Placebo|Patients treated with placebo ointment
161044|NCT01708915|E4|Reported Event|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide alone
161045|NCT01708915|E3|Reported Event|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
161046|NCT01708915|E2|Reported Event|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
161047|NCT01708915|E1|Reported Event|Placebo|Patients treated with placebo ointment
161048|NCT01708902|B8|Baseline|Total|Total of all reporting groups
179117|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
161049|NCT01708902|B7|Baseline|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
161050|NCT01708902|B6|Baseline|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
161051|NCT01708902|B5|Baseline|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
161052|NCT01708902|B4|Baseline|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
161053|NCT01708902|B3|Baseline|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
161054|NCT01708902|B2|Baseline|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
161055|NCT01708902|B1|Baseline|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
161056|NCT01708902|P7|Participant Flow|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
161057|NCT01708902|P6|Participant Flow|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg once daily (QD), administered oral as tablet.~(Data up to week 12)"
161058|NCT01708902|P5|Participant Flow|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.
161059|NCT01708902|P4|Participant Flow|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.
161060|NCT01708902|P3|Participant Flow|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg twice daily (BID), administered oral as tablet.
161061|NCT01708902|P2|Participant Flow|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg twice daily (BID), administered oral as tablet.
161062|NCT01708902|P1|Participant Flow|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg once daily (QD), administered oral as tablet.
161063|NCT01708902|O2|Outcome|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
161064|NCT01708902|O1|Outcome|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
161065|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
161066|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
161067|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
161068|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
161069|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
161070|NCT01708902|O2|Outcome|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
161071|NCT01708902|O1|Outcome|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
161072|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
161073|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
161074|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
161075|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
161076|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
161077|NCT01708902|O2|Outcome|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
161078|NCT01708902|O1|Outcome|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
161079|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
161080|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
161081|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
161082|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
161083|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
161084|NCT01708902|O2|Outcome|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
161085|NCT01708902|O1|Outcome|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
161170|NCT01708213|O1|Outcome|Dermal Filler - Aline HA|"Non-Randomized~Aline HA: Implantable dermal filler"
161086|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
161087|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
161088|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
161089|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
161090|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
161091|NCT01708902|O2|Outcome|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
161092|NCT01708902|O1|Outcome|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
161093|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
161094|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
161095|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
161096|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
161097|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
161098|NCT01708902|O2|Outcome|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
161099|NCT01708902|O1|Outcome|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
161100|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
161101|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
161102|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
161103|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
161104|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
161105|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
161106|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
161107|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
161108|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
161109|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
161110|NCT01708902|E10|Reported Event|APG: Linagliptin 2.5mg / Metformin 1000mg After Week 12|"Additional parallel group (APG): Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~Data from week 12 to week 24."
161111|NCT01708902|E9|Reported Event|APG: Linagliptin 5mg - Linagliptin 2.5mg / Met After Week 12|Additional parallel group (APG): Patients who received linagliptin 5mg QD, administered oral as tablet during the first 12 weeks and switched to linagliptin 2.5mg and metformin 1000mg (met) BID, administered oral as fixed dose combination (FDC) tablet from week 12 to week 24. Data from week 12 to week 24.
161112|NCT01708902|E8|Reported Event|APG: Linagliptin 5mg After Week 12|Additional parallel group (APG): Patients once daily received linagliptin 5mg QD, administered oral as tablet. Data from week 12 to week 24
161113|NCT01708902|E7|Reported Event|APG: Linagliptin 2.5mg / Metformin 1000mg BID up to Week 12|"Additional parallel group (APG): Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
161114|NCT01708902|E6|Reported Event|APG: Linagliptin 5mg QD up to Week 12|"Additional parallel group (APG): Patients once daily received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
161115|NCT01708902|E5|Reported Event|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
161116|NCT01708902|E4|Reported Event|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients twice daily received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
161117|NCT01708902|E3|Reported Event|Main: Metformin 1000mg BID|Main Group: Patients twice daily received metformin 1000mg BID, administered oral as tablet.
161118|NCT01708902|E2|Reported Event|Main: Metformin 500mg BID|Main Group: Patients twice daily received metformin 500mg BID, administered oral as tablet.
161119|NCT01708902|E1|Reported Event|Main: Linagliptin 5mg QD|Main Group: Patients once daily received linagliptin 5mg QD, administered oral as tablet.
161120|NCT01708525|B1|Baseline|Ultherapy®-Treated Tissue|"Heavy water labeled tissue receiving an Ultherapy® Treatment~Ulthera System® Treatment: Focused ultrasound energy delivered below the surface of the skin"
161121|NCT01708525|P1|Participant Flow|Ultherapy®-Treated Tissue|"Heavy water labeled tissue receiving an Ultherapy® Treatment~Ulthera System® Treatment: Focused ultrasound energy delivered below the surface of the skin"
162035|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
161122|NCT01708525|O2|Outcome|Ultherapy®-Treated Tissue|"Heavy water labeled tissue receiving an Ultherapy® Treatment~Ulthera® System Treatment: Focused ultrasound energy delivered below the surface of the skin"
161123|NCT01708525|O1|Outcome|Untreated Tissue|Heavy water labeled tissue NOT receiving an Ultherapy® Treatment
161124|NCT01708525|E1|Reported Event|Ultherapy®-Treated Tissue|"Heavy water labeled tissue receiving an Ultherapy® Treatment~Ulthera System® Treatment: Focused ultrasound energy delivered below the surface of the skin"
161125|NCT01708317|B1|Baseline|ACASI|"The group of patients that agreed to participate in the study and answer questions on our Audio-enhanced Computer-Assisted Self-Interview (ACASI)~ACASI : Youth who participated in this study completed the ACASI -- they provided details about their sexual history, and the software program used their responses to create a recommendation for chlamydia/gonorrhea testing. The information obtained through the ACASI was integrated into the emergency department (ED) electronic medical record. ED physicians and nurses were able to review the information and order chlamydia/gonorrhea testing if needed.~We compared testing over 4 time periods: 2010 (baseline), Jan - April 17, 2011 (education only), April 18-2011 - Dec 20, 2011 (education + enrollment in ACASI), and Dec 21, 2011 - March 31, 2012 (education only, ACASI enrollment stopped."
161126|NCT01708317|P1|Participant Flow|ACASI|"The group of patients that agreed to participate in the study and answer questions on our Audio-enhanced Computer-Assisted Self-Interview (ACASI)~ACASI : Youth who participated in this study completed the ACASI -- they provided details about their sexual history, and the software program used their responses to create a recommendation for chlamydia/gonorrhea testing. The information obtained through the ACASI was integrated into the emergency department (ED) electronic medical record. ED physicians and nurses were able to review the information and order chlamydia/gonorrhea testing if needed.~We compared testing over 4 time periods: 2010 (baseline), Jan - April 17, 2011 (education only), April 18-2011 - Dec 20, 2011 (education + enrollment in ACASI), and Dec 21, 2011 - March 31, 2012 (education only, ACASI enrollment stopped."
161127|NCT01708317|O4|Outcome|Final Education Period|Participants seen in SLCH ED Dec 21, 2011 through March 2012 that met ACASI inclusion/exclusion criteria. During this period education continued and no ACASI enrollment was conducted.
161128|NCT01708317|O3|Outcome|ACASI + Education|Participants seen in SLCH ED April 18 - Dec 20 2011 that met ACASI inclusion/exclusion criteria. During this period education continued and ACASI enrollment was conducted.
161129|NCT01708317|O2|Outcome|Initial Education Period|Participants seen in SLCH ED Jan 1 - April 17 2011 during initial education period that met ACASI inclusion/exclusion criteria
161130|NCT01708317|O1|Outcome|Historical Control|Participants seen in SLCH ED in 2010 that met ACASI inclusion/exclusion criteria
161131|NCT01708317|E1|Reported Event|ACASI|"The group of patients that agreed to participate in the study and answer questions on our Audio-enhanced Computer-Assisted Self-Interview (ACASI)~ACASI : Youth who participated in this study completed the ACASI -- they provided details about their sexual history, and the software program used their responses to create a recommendation for chlamydia/gonorrhea testing. The information obtained through the ACASI was integrated into the emergency department (ED) electronic medical record. ED physicians and nurses were able to review the information and order chlamydia/gonorrhea testing if needed.~We compared testing over 4 time periods: 2010 (baseline), Jan - April 17, 2011 (education only), April 18-2011 - Dec 20, 2011 (education + enrollment in ACASI), and Dec 21, 2011 - March 31, 2012 (education only, ACASI enrollment stopped."
161132|NCT01708291|B3|Baseline|Total|Total of all reporting groups
161133|NCT01708291|B2|Baseline|No Mindfulness Based Stress Reduction|Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
161134|NCT01708291|B1|Baseline|Mindfulness Based Stress Reduction|Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.
161135|NCT01708291|P2|Participant Flow|No Mindfulness Based Stress Reduction|Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
161136|NCT01708291|P1|Participant Flow|Mindfulness Based Stress Reduction|Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.
161137|NCT01708291|O2|Outcome|No Mindfulness Based Stress Reduction|Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
161138|NCT01708291|O1|Outcome|Mindfulness Based Stress Reduction|Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.
161139|NCT01708291|E2|Reported Event|No Mindfulness Based Stress Reduction|Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
161140|NCT01708291|E1|Reported Event|Mindfulness Based Stress Reduction|Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.
161141|NCT01708278|B7|Baseline|Total|Total of all reporting groups
161142|NCT01708278|B6|Baseline|Sugar Chew-Cohort 3|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
161143|NCT01708278|B5|Baseline|Sugar Chew-Cohort 2|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
161144|NCT01708278|B4|Baseline|Quercetin 3-Cohort 3|"Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
161145|NCT01708278|B3|Baseline|Quercetin 2-Cohort 2|"Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
161146|NCT01708278|B2|Baseline|Quercetin 1-Cohort 1|"Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
161147|NCT01708278|B1|Baseline|Sugar Chew- Cohort 1|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
161148|NCT01708278|P6|Participant Flow|Sugar Chew-Cohort 3|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
161149|NCT01708278|P5|Participant Flow|Sugar Chew-Cohort 2|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
161150|NCT01708278|P4|Participant Flow|Quercetin 3-Cohort 3|"Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
161151|NCT01708278|P3|Participant Flow|Quercetin 2-Cohort 2|"Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
161152|NCT01708278|P2|Participant Flow|Quercetin 1-Cohort 1|"Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
161153|NCT01708278|P1|Participant Flow|Sugar Chew- Cohort 1|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
161154|NCT01708278|O6|Outcome|Sugar Chew-Cohort 3|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
161155|NCT01708278|O5|Outcome|Sugar Chew-Cohort 2|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
161156|NCT01708278|O4|Outcome|Quercetin 3-Cohort 3|"Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
161157|NCT01708278|O3|Outcome|Quercetin 2-Cohort 2|"Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
161158|NCT01708278|O2|Outcome|Quercetin 1-Cohort 1|"Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
161159|NCT01708278|O1|Outcome|Sugar Chew- Cohort 1|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
161160|NCT01708278|E6|Reported Event|Sugar Chew-Cohort 3|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
161161|NCT01708278|E5|Reported Event|Sugar Chew-Cohort 2|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
161162|NCT01708278|E4|Reported Event|Quercetin 3-Cohort 3|"Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
161163|NCT01708278|E3|Reported Event|Quercetin 2-Cohort 2|"Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
161164|NCT01708278|E2|Reported Event|Quercetin 1-Cohort 1|"Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
161165|NCT01708278|E1|Reported Event|Sugar Chew-Cohort 1|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
161166|NCT01708213|B1|Baseline|Dermal Filler - Aline HA|"Single armed study~Aline HA: Implantable dermal filler"
161167|NCT01708213|P1|Participant Flow|Dermal Filler - Aline HA|"Non-Randomized~Aline HA: Implantable dermal filler"
161171|NCT01708213|E1|Reported Event|Dermal Filler - Aline HA|To evaluate the safety and performance of Aline HA to treat mild to severe wrinkles in adult subjects
161172|NCT01708187|B3|Baseline|Total|Total of all reporting groups
161173|NCT01708187|B2|Baseline|Control Arm Without Clarix™1k Graft|Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.
161174|NCT01708187|B1|Baseline|Clarix™1k Graft|Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.
161175|NCT01708187|P2|Participant Flow|Control Arm Without Clarix™1k Graft|Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.
161176|NCT01708187|P1|Participant Flow|Clarix™1k Graft|Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.
161177|NCT01708187|O2|Outcome|Control Arm Without Clarix™1k Graft|Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.
161178|NCT01708187|O1|Outcome|Clarix™1k Graft|Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.
161179|NCT01708187|E2|Reported Event|Control Arm Without Clarix™1k Graft|Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.
161180|NCT01708187|E1|Reported Event|Clarix™1k Graft|Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.
161181|NCT01708174|B4|Baseline|Total|Total of all reporting groups
161182|NCT01708174|B3|Baseline|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
161183|NCT01708174|B2|Baseline|Sonidegib (LDE225) Adults|600 mg orally
161184|NCT01708174|B1|Baseline|Sonidegib (LDE225) Children|500 mg/m2 orally
161185|NCT01708174|P3|Participant Flow|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
161186|NCT01708174|P2|Participant Flow|Sonidegib (LDE225) Adults|600 mg orally
161187|NCT01708174|P1|Participant Flow|Sonidegib (LDE225) Children|500 mg/m2 orally
161188|NCT01708174|O2|Outcome|Sonidegib (LDE225) Adults|600 mg orally
161189|NCT01708174|O1|Outcome|Sonidegib (LDE225) Children|500 mg/m2 orally
161190|NCT01708174|O3|Outcome|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
161191|NCT01708174|O2|Outcome|Sonidegib (LDE225) Adults|600 mg orally
161192|NCT01708174|O1|Outcome|Sonidegib (LDE225) Children|500 mg/m2 orally
161193|NCT01708174|O3|Outcome|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
161194|NCT01708174|O2|Outcome|Sonidegib (LDE225) Adults|600 mg orally
161195|NCT01708174|O1|Outcome|Sonidegib (LDE225) Children|500 mg/m2 orally
161196|NCT01708174|O3|Outcome|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
161197|NCT01708174|O2|Outcome|Sonidegib (LDE225) Adults|600 mg orally
161198|NCT01708174|O1|Outcome|Sonidegib (LDE225) Children|500 mg/m2 orally
161199|NCT01708174|O3|Outcome|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
161200|NCT01708174|O2|Outcome|Sonidegib (LDE225) Adults|600 mg orally
161201|NCT01708174|O1|Outcome|Sonidegib (LDE225) Children|500 mg/m2 orally
161202|NCT01708174|O3|Outcome|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
161203|NCT01708174|O2|Outcome|Sonidegib (LDE225) Adults|600 mg orally
161204|NCT01708174|O1|Outcome|Sonidegib (LDE225) Children|500 mg/m2 orally
161205|NCT01708174|O3|Outcome|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
161206|NCT01708174|O2|Outcome|Sonidegib (LDE225) Adults|600 mg orally
161207|NCT01708174|O1|Outcome|Sonidegib (LDE225) Children|500 mg/m2 orally
161208|NCT01708174|E4|Reported Event|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
161209|NCT01708174|E3|Reported Event|Sonidegib (Total)|Sonidegib (Total)
161210|NCT01708174|E2|Reported Event|Sonidegib (LDE225) Adults|600 mg orally
161211|NCT01708174|E1|Reported Event|Sonidegib (LDE225) Children|500 mg/m2 orally
161212|NCT01708122|B3|Baseline|Total|Total of all reporting groups
161213|NCT01708122|B2|Baseline|Placebo|"Subjects will receive intranasal saline as placebo.~Saline: Sodium Chloride 0.9% intranasal spray"
161214|NCT01708122|B1|Baseline|Fentanyl|"Subjects will receive 50 to 100 mcg intranasal fentanyl~Fentanyl: 100 mcg in 1 mL intranasal spray"
161215|NCT01708122|P2|Participant Flow|Fentanyl|Subjects receiving either 50mcg or 100mcg
161216|NCT01708122|P1|Participant Flow|Placebo|"Subjects will receive 0.1 mL of intranasal saline as placebo.~saline: Sodium Chloride 0.9% intranasal spray"
161217|NCT01708122|O2|Outcome|Placebo|"Subjects will receive intranasal saline as placebo.~Saline: Sodium Chloride 0.9% intranasal spray"
161218|NCT01708122|O1|Outcome|Fentanyl|"Subjects will receive 50 to 100 mcg intranasal fentanyl~Fentanyl: 100 mcg in 1 mL intranasal spray"
161219|NCT01708122|O2|Outcome|Placebo|"Subjects will receive intranasal saline as placebo.~Saline: Sodium Chloride 0.9% intranasal spray"
161220|NCT01708122|O1|Outcome|Fentanyl|"Subjects will receive 50 to 100 mcg intranasal fentanyl~Fentanyl: 100 mcg in 1 mL intranasal spray"
161221|NCT01708122|E2|Reported Event|Placebo|"Subjects receiving either 0.5mL or 1 mL intranasal saline as placebo.~Saline: Sodium Chloride 0.9% intranasal spray"
161222|NCT01708122|E1|Reported Event|Fentanyl|"Subjects receiving either 0.5mL or 1 mL of intranasal fentanyl (50mcg or 100mcg)~Fentanyl: 100 mcg in 1 mL intranasal spray"
161223|NCT01708057|B1|Baseline|Total Baseline|All Patients population
161224|NCT01708057|P3|Participant Flow|DCEBFA|AZD8683 900 ug followed by AZD8683 300 ug followed by Spiriva® 18 ug followed by AZD8683 150 ug followed by Placebo followed by AZD8683 50 ug
161225|NCT01708057|P2|Participant Flow|FEADBC|Placebo followed by Spiriva® 18 ug followed by AZD8683 50 ug followed by AZD8683 900 ug followed by AZD8683 150 ug followed by AZD8683 300 ug
161226|NCT01708057|P1|Participant Flow|AFBECD|AZD8683 50 ug followed by Placebo followed by AZD8683 150 ug followed by Spiriva® 18 ug followed by AZD8683 300 ug followed by AZD8683 900 ug
161227|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
161228|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
161229|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
161230|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
161231|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
161232|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
161233|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
161234|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
161235|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
161236|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
161237|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
161238|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
161239|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
161240|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
161241|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
161242|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
161243|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
161244|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
161245|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
161246|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
161247|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
161248|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
161249|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
161250|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
161251|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
161252|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
161253|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
161254|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
161255|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
161256|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
161257|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
161258|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
161259|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
161260|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
161261|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
161262|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
161263|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
161264|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
161265|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
161266|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
161267|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
161268|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
161269|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
161270|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
161271|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
161272|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
161273|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
161274|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
161275|NCT01708057|E6|Reported Event|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
161276|NCT01708057|E5|Reported Event|18ug Spiriva|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
161277|NCT01708057|E4|Reported Event|900 ug AZD8683|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler;
161278|NCT01708057|E3|Reported Event|300 ug AZD8683|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
161279|NCT01708057|E2|Reported Event|150 ug AZD8683|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
162036|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
161282|NCT01707667|B2|Baseline|PEG-PRU|Two doses of PEG 3350 (13.8g) plus electrolytes in the first period followed by a single dose of prucalopride 2mg in the second period.
161283|NCT01707667|B1|Baseline|PRU-PEG|A single dose of prucalopride 2mg in the first period followed by 2 doses of polyethylene glycol (PEG) 3350 (13.8g) plus electrolytes in the second period.
161284|NCT01707667|P2|Participant Flow|PEG-PRU|Two doses of PEG 3350 (13.8g) plus electrolytes in the first period followed by a single dose of prucalopride 2mg in the second period.
161285|NCT01707667|P1|Participant Flow|PRU-PEG|A single dose of prucalopride 2mg in the first period followed by 2 doses of polyethylene glycol (PEG) 3350 (13.8g) plus electrolytes in the second period.
161286|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
161287|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
161288|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
161289|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
161290|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
161291|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
161292|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
161293|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
161294|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
161295|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
161296|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
161297|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
161298|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
161299|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
161300|NCT01707667|E2|Reported Event|Polyethylene Glycol|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
161301|NCT01707667|E1|Reported Event|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
161302|NCT01707654|B1|Baseline|Nerve Graft|Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.
161303|NCT01707654|P1|Participant Flow|Nerve Graft|Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.
161304|NCT01707654|O1|Outcome|Nerve Graft|Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.
161305|NCT01707654|E1|Reported Event|Nerve Graft|Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.
161306|NCT01707290|B3|Baseline|Total|Total of all reporting groups
161307|NCT01707290|B2|Baseline|Observational Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet q12h in the previous Study 110 (NCT01614457) or Study 111 (NCT01614470), were observed (did not receive study drug) in this Study 112 (NCT01707290) for up to 2 years.
161308|NCT01707290|B1|Baseline|Ivacaftor Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet, q12h in the previous study VX11-770-110 (Study 110; NCT01614457), VX12-770-111 (Study 111; NCT01614470) or VX12-770-113 (Study 113; NCT01685801); received Ivacaftor 150 mg tablet orally q12h in this VX12-770-112 (Study 112; NCT01707290) up to 104 weeks.
161309|NCT01707290|P2|Participant Flow|Observational Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet q12h in the previous Study 110 (NCT01614457) or Study 111 (NCT01614470), were observed (did not receive study drug) in this Study 112 (NCT01707290) for up to 2 years.
161310|NCT01707290|P1|Participant Flow|Ivacaftor Arm|Participants who received Ivacaftor 150 milligram (mg) tablet and/or Placebo matched to Ivacaftor tablet, every 12 hours (q12h) in the previous study VX11-770-110 (Study 110; NCT01614457), VX12-770-111 (Study 111; NCT01614470) or VX12-770-113 (Study 113; NCT01685801); received Ivacaftor 150 mg tablet orally q12h in this VX12-770-112 (Study 112; NCT01707290) up to 104 weeks.
161311|NCT01707290|O1|Outcome|Observational Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet, orally, q12h in the previous Study 110 (NCT01614457) or Study 111 (NCT01614470), were observed (did not receive study drug) in this Study 112 (NCT01707290) for up to 2 years.
161312|NCT01707290|O3|Outcome|Ivacaftor Arm: Study 113|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 113; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
161313|NCT01707290|O2|Outcome|Ivacaftor Arm: Study 111|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 111; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
183466|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
161314|NCT01707290|O1|Outcome|Ivacaftor Arm: Study 110|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 110; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
161315|NCT01707290|O3|Outcome|Ivacaftor Arm: Study 113|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 113; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
161316|NCT01707290|O2|Outcome|Ivacaftor Arm: Study 111|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 111; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
161317|NCT01707290|O1|Outcome|Ivacaftor Arm: Study 110|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 110; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
161318|NCT01707290|O3|Outcome|Ivacaftor Arm: Study 113|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 113; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
161319|NCT01707290|O2|Outcome|Ivacaftor Arm: Study 111|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 111; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
161320|NCT01707290|O1|Outcome|Ivacaftor Arm: Study 110|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 110; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
161321|NCT01707290|O3|Outcome|Ivacaftor Arm: Study 113|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 113; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
161322|NCT01707290|O2|Outcome|Ivacaftor Arm: Study 111|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 111; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
161323|NCT01707290|O1|Outcome|Ivacaftor Arm: Study 110|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 110; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
161324|NCT01707290|O3|Outcome|Ivacaftor Arm: Study 113|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 113; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
161325|NCT01707290|O2|Outcome|Ivacaftor Arm: Study 111|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 111; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
161326|NCT01707290|O1|Outcome|Ivacaftor Arm: Study 110|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 110; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
161327|NCT01707290|O1|Outcome|Ivacaftor Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet q12h in the previous study VX11-770-110 (Study 110; NCT01614457), VX12-770-111 (Study 111; NCT01614470) or VX12-770-113 (Study 113; NCT01685801); received Ivacaftor 150 mg tablet orally q12h in this VX12-770-112 (Study 112; NCT01707290) up to 104 weeks.
161328|NCT01707290|E2|Reported Event|Observational Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet q12h in the previous Study 110 (NCT01614457) or Study 111 (NCT01614470), were observed (did not receive study drug) in this Study 112 (NCT01707290) for up to 2 years.
161329|NCT01707290|E1|Reported Event|Ivacaftor Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet q12h in the previous study VX11-770-110 (Study 110; NCT01614457), VX12-770-111 (Study 111; NCT01614470) or VX12-770-113 (Study 113; NCT01685801); received Ivacaftor 150 mg tablet orally q12h in this VX12-770-112 (Study 112; NCT01707290) up to 104 weeks.
161330|NCT01707238|B3|Baseline|Total|Total of all reporting groups
161331|NCT01707238|B2|Baseline|Etafilcon A Then Stenfilcon A|All subjects assigned as overall study population wore both sets of lenses. Overall study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.
161332|NCT01707238|B1|Baseline|Stenfilcon A Then Etafilcon A|All subjects assigned as overall study population wore both sets of lenses. Overall study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.
161333|NCT01707238|P2|Participant Flow|Etafilcon A Then Stenfilcon A|All subjects assigned as overall study population wore both sets of lenses. Study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.
161334|NCT01707238|P1|Participant Flow|Stenfilcon A Then Etafilcon A|All subjects assigned as overall study population wore both sets of lenses. Overall study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.
161335|NCT01707238|O2|Outcome|Etafilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
161336|NCT01707238|O1|Outcome|Stenfilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
161337|NCT01707238|O2|Outcome|Etafilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
161338|NCT01707238|O1|Outcome|Stenfilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
161339|NCT01707238|O2|Outcome|Etafilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
161340|NCT01707238|O1|Outcome|Stenfilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
183467|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
161341|NCT01707238|O2|Outcome|Etafilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
161342|NCT01707238|O1|Outcome|Stenfilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.).
161343|NCT01707238|O2|Outcome|Etafilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
161344|NCT01707238|O1|Outcome|Stenfilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
161345|NCT01707238|O2|Outcome|Etafilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
161346|NCT01707238|O1|Outcome|Stenfilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
161347|NCT01707238|E2|Reported Event|Etafilcon A|Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
161348|NCT01707238|E1|Reported Event|Stenfilcon A|Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
161349|NCT01707225|B1|Baseline|Octreotide LAR Depot|"Once enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.~Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study."
161350|NCT01707225|P1|Participant Flow|Octreotide LAR Depot|"Once enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.~Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study."
161351|NCT01707225|O1|Outcome|Octreotide LAR Depot|"Once enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.~Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study."
161352|NCT01707225|O1|Outcome|Octreotide LAR Depot|"Once enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.~Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study."
161353|NCT01707225|E1|Reported Event|Octreotide LAR Depot|"Once enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.~Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study."
161354|NCT01707095|B3|Baseline|Total|Total of all reporting groups
161355|NCT01707095|B2|Baseline|Unbundling of Cords|"The active electrode and camera cords will be place off opposite sides of the table and will not run adjacent to or in parallel with one another~Unbundling of cords: The active electrode and camera cords will be place off opposite sides of the table and will not run adjacent to or in parallel with one another"
162037|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
161356|NCT01707095|B1|Baseline|Bundling of Cords|"The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy.~Bundling of cords: The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy."
161357|NCT01707095|P2|Participant Flow|Unbundled / Separated|Active electrode cord and camera cord separated
161358|NCT01707095|P1|Participant Flow|Bundled|Active electrode cord and camera cord parallel
161359|NCT01707095|O2|Outcome|Unbundled / Separated|Active electrode cord and camera cord separated
161360|NCT01707095|O1|Outcome|Bundled|Active electrode cord and camera cord parallel
161361|NCT01707095|O2|Outcome|Unbundled / Separated|Active electrode cord and camera cord separated
161362|NCT01707095|O1|Outcome|Bundled|Active electrode cord and camera cord parallel
161363|NCT01707095|E2|Reported Event|Unbundled / Separated|Active electrode cord and camera cord separated
161364|NCT01707095|E1|Reported Event|Bundled|Active electrode cord and camera cord parallel
161365|NCT01707043|B3|Baseline|Total|Total of all reporting groups
161366|NCT01707043|B2|Baseline|Taclonex Ointment First Then Taclonex Scalp Suspension|All subjects will use Taclonex Ointment to psoriasis twice daily for 3 days Subjects will then cross over to use Taclonex Scalp Suspension for 3 days.There is no washout between products.
161367|NCT01707043|B1|Baseline|Taclonex Scalp Suspension First, the Taclonex Ointment|All subjects will use Taclonex Scalp Suspension first to psoriasis twice daily for 3 days Subjects will then cross over to use Taclonex Ointment for 3 days.There is no washout between products.
161368|NCT01707043|P2|Participant Flow|Taclonex Ointment First, Then Taclonex Scalp Suspension|All subjects will use Taclonex Ointment to psoriasis twice daily for 3 days Subjects will then cross over to use Taclonex Scalp Suspension for 3 days.There is no washout between products.
161369|NCT01707043|P1|Participant Flow|Taclonex Scalp Suspension First, Then Taclonex Ointment|"All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas of psoriasis for three days.~Subjects will then cross over to use Taclonex ointment for 3 days. There is no washout between products."
161370|NCT01707043|O2|Outcome|Taclonex Ointment First, Then Taclonex Scalp Suspension|"All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment once daily to affected areas of psoriasis for three days.~Subjects will then cross over to use Taclonex Suspension for 3 days. There is no washout between products."
161371|NCT01707043|O1|Outcome|Taclonex Scalp Suspension First Then Taclonex Ointment|"All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas of psoriasis for three days.~Subjects will then cross over to use Taclonex ointment for 3 days. There is no washout between products."
161372|NCT01707043|O2|Outcome|Taclonex Ointment First, Then Taclonex Scalp Suspension|"All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment once daily to affected areas of psoriasis for three days.~Subjects will then cross over to use Taclonex Suspension for 3 days. There is no washout between products."
161373|NCT01707043|O1|Outcome|Taclonex Scalp Suspension First Then Taclonex Ointment|"All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas of psoriasis for three days.~Subjects will then cross over to use Taclonex ointment for 3 days. There is no washout between products."
161374|NCT01707043|E2|Reported Event|Taclonex Scalp Suspension|"All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas for three days.~In this arm, subjects will give a preference rating for the Suspension"
161375|NCT01707043|E1|Reported Event|Taclonex Ointment|All subjects will use Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment once daily for three days to affected areas In this arm, subject will give a preference rating for Taclonex Ointment
161376|NCT01706965|B3|Baseline|Total|Total of all reporting groups
161377|NCT01706965|B2|Baseline|Multivitamin|"Daily multivitamin tablet~Multivitamin: Multi-vitamin will be used as an active control in this study. Will be dosed daily"
161378|NCT01706965|B1|Baseline|Kuvan|"Kuvan once-daily dosing initiated with 10mg/kg for the first week followed by 20mg/kg for the remaining weeks of the study~Kuvan: 20mg/kg using a daily dosing schedule. To increase tolerability, treatment will be initiated at 10mg/kg for the first week of the study. Given the short length of the trial, no dose adjustments will be made for changes in weight"
161379|NCT01706965|P2|Participant Flow|Multivitamin|"Daily multivitamin tablet~Multivitamin: Multi-vitamin will be used as an active control in this study. Will be dosed daily"
161380|NCT01706965|P1|Participant Flow|Kuvan|"Kuvan once-daily dosing initiated with 10mg/kg for the first week followed by 20mg/kg for the remaining weeks of the study~Kuvan: 20mg/kg using a daily dosing schedule. To increase tolerability, treatment will be initiated at 10mg/kg for the first week of the study. Given the short length of the trial, no dose adjustments will be made for changes in weight"
161381|NCT01706965|O2|Outcome|Multivitamin|"Daily multivitamin tablet~Multivitamin: Multi-vitamin will be used as an active control in this study. Will be dosed daily"
161382|NCT01706965|O1|Outcome|Kuvan|"Kuvan once-daily dosing initiated with 10mg/kg for the first week followed by 20mg/kg for the remaining weeks of the study~Kuvan: 20mg/kg using a daily dosing schedule. To increase tolerability, treatment will be initiated at 10mg/kg for the first week of the study. Given the short length of the trial, no dose adjustments will be made for changes in weight"
161383|NCT01706965|O2|Outcome|Multivitamin|"Daily multivitamin tablet~Multivitamin: Multi-vitamin will be used as an active control in this study. Will be dosed daily"
161384|NCT01706965|O1|Outcome|Kuvan|"Kuvan once-daily dosing initiated with 10mg/kg for the first week followed by 20mg/kg for the remaining weeks of the study~Kuvan: 20mg/kg using a daily dosing schedule. To increase tolerability, treatment will be initiated at 10mg/kg for the first week of the study. Given the short length of the trial, no dose adjustments will be made for changes in weight"
161385|NCT01706965|E2|Reported Event|Multivitamin|"Daily multivitamin tablet~Multivitamin: Multi-vitamin will be used as an active control in this study. Will be dosed daily"
161424|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161386|NCT01706965|E1|Reported Event|Kuvan|"Kuvan once-daily dosing initiated with 10mg/kg for the first week followed by 20mg/kg for the remaining weeks of the study~Kuvan: 20mg/kg using a daily dosing schedule. To increase tolerability, treatment will be initiated at 10mg/kg for the first week of the study. Given the short length of the trial, no dose adjustments will be made for changes in weight"
161387|NCT01706952|B1|Baseline|Cocaine/Adrenaline|"Three cotton neuropatties will be placed in each nostril. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This intervention will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
161388|NCT01706952|P1|Participant Flow|Cocaine/Adrenaline|"Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side).~Three cotton neuropatties will be placed in each side of the nostril. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This intervention will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose."
161389|NCT01706952|O2|Outcome|Adrenaline SIDE|"Adrenaline 1/1.000 Three cotton neuropatties will be soaked with Adrenaline 1/1,000. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
161390|NCT01706952|O1|Outcome|Cocaine SIDE|"Cocaine 4%. Three cotton neuropatties will be soaked with 4% cocaine. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This intervention will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
161391|NCT01706952|O2|Outcome|Adrenaline SIDE|"Adrenaline 1/1.000 Three cotton neuropatties will be soaked with Adrenaline 1/1,000. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
161392|NCT01706952|O1|Outcome|Cocaine SIDE|"Cocaine 4%. Three cotton neuropatties will be soaked with 4% cocaine. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This intervention will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
161393|NCT01706952|O2|Outcome|Adrenaline SIDE|"Adrenaline 1/1.000 Three cotton neuropatties will be soaked with Adrenaline 1/1,000. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
161394|NCT01706952|O1|Outcome|Cocaine SIDE|"Cocaine 4%. Three cotton neuropatties will be soaked with 4% cocaine. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This intervention will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
161395|NCT01706952|O2|Outcome|Adrenaline SIDE|"Adrenaline 1/1.000 Three cotton neuropatties will be soaked with Adrenaline 1/1,000. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
161396|NCT01706952|O1|Outcome|Cocaine SIDE|"Cocaine 4%. Three cotton neuropatties will be soaked with 4% cocaine. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This intervention will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
161554|NCT01706588|B5|Baseline|Placebo 1 mL|One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
161397|NCT01706952|E2|Reported Event|Adrenaline|"Adrenaline 1/1.000 Three cotton neuropatties will be soaked with Adrenaline 1/1,000. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
161398|NCT01706952|E1|Reported Event|Cocaine|"Cocaine 4%. Three cotton neuropatties will be soaked with 4% cocaine. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This intervention will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
161399|NCT01706926|B5|Baseline|Total|Total of all reporting groups
161400|NCT01706926|B4|Baseline|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161401|NCT01706926|B3|Baseline|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161402|NCT01706926|B2|Baseline|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161403|NCT01706926|B1|Baseline|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161404|NCT01706926|P4|Participant Flow|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161405|NCT01706926|P3|Participant Flow|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161406|NCT01706926|P2|Participant Flow|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161407|NCT01706926|P1|Participant Flow|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161408|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161409|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161410|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161411|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161412|NCT01706926|O3|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161413|NCT01706926|O2|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161414|NCT01706926|O1|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161415|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161416|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161417|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161418|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161419|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161420|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161421|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161422|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161423|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161425|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161426|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161427|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161428|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161429|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161430|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161431|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161432|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161433|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161434|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161435|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161436|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161437|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161438|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161439|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161440|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161441|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161442|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161443|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161444|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161445|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161446|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161447|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161448|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161449|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161450|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161451|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161452|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161453|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161454|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161455|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161456|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161457|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161458|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161459|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161460|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161461|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161462|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161463|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161464|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161465|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161466|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161467|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161468|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161469|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161470|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161471|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161472|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161473|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161474|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161475|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161476|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161477|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161478|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161479|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161480|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161481|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161482|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161483|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161484|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161485|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161486|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161487|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161488|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161489|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161490|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161491|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161492|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161493|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161494|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161495|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161496|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161497|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161498|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161499|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161500|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161501|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161502|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161503|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161504|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161505|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161506|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161507|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161508|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161509|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161510|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161511|NCT01706926|E4|Reported Event|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161512|NCT01706926|E3|Reported Event|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161513|NCT01706926|E2|Reported Event|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
161555|NCT01706588|B4|Baseline|Diclofenac Sodium 50 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
161514|NCT01706926|E1|Reported Event|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
161515|NCT01706822|B1|Baseline|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy
161516|NCT01706822|P1|Participant Flow|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
161517|NCT01706822|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
161518|NCT01706822|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
161519|NCT01706822|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
161520|NCT01706822|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
161521|NCT01706822|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
161522|NCT01706822|E1|Reported Event|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy
161523|NCT01706770|B3|Baseline|Total|Total of all reporting groups
161524|NCT01706770|B2|Baseline|Galyfilcon A|The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
161525|NCT01706770|B1|Baseline|Enfilcon A|The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
161526|NCT01706770|P2|Participant Flow|Galyfilcon A|The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
161527|NCT01706770|P1|Participant Flow|Enfilcon A|The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
161528|NCT01706770|O2|Outcome|Galyfilcon A|The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
161529|NCT01706770|O1|Outcome|Enfilcon A|The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
161530|NCT01706770|O2|Outcome|Galyfilcon A|The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
161531|NCT01706770|O1|Outcome|Enfilcon A|The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
161532|NCT01706770|E2|Reported Event|Galyfilcon A|The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
161533|NCT01706770|E1|Reported Event|Enfilcon A|The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
161534|NCT01706666|B4|Baseline|Total|Total of all reporting groups
161535|NCT01706666|B3|Baseline|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
161536|NCT01706666|B2|Baseline|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
161537|NCT01706666|B1|Baseline|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
161538|NCT01706666|P3|Participant Flow|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
161539|NCT01706666|P2|Participant Flow|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
161540|NCT01706666|P1|Participant Flow|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
161541|NCT01706666|O3|Outcome|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
161542|NCT01706666|O2|Outcome|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
161543|NCT01706666|O1|Outcome|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
161544|NCT01706666|O3|Outcome|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
161545|NCT01706666|O2|Outcome|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
161546|NCT01706666|O1|Outcome|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
161547|NCT01706666|O3|Outcome|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
161548|NCT01706666|O2|Outcome|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
161549|NCT01706666|O1|Outcome|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
161550|NCT01706666|E3|Reported Event|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
161551|NCT01706666|E2|Reported Event|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
161552|NCT01706666|E1|Reported Event|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
161553|NCT01706588|B6|Baseline|Total|Total of all reporting groups
183468|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
161556|NCT01706588|B3|Baseline|Diclofenac Sodium 25 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
161557|NCT01706588|B2|Baseline|Diclofenac Sodium 12.5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
161558|NCT01706588|B1|Baseline|Diclofenac Sodium 5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
161559|NCT01706588|P5|Participant Flow|Placebo 1 mL|One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
161560|NCT01706588|P4|Participant Flow|Diclofenac Sodium 50 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
161561|NCT01706588|P3|Participant Flow|Diclofenac Sodium 25 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
161562|NCT01706588|P2|Participant Flow|Diclofenac Sodium 12.5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
161563|NCT01706588|P1|Participant Flow|Diclofenac Sodium 5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
161564|NCT01706588|O5|Outcome|Placebo 1 mL|One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
161565|NCT01706588|O4|Outcome|Diclofenac Sodium 50 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
161566|NCT01706588|O3|Outcome|Diclofenac Sodium 25 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
161567|NCT01706588|O2|Outcome|Diclofenac Sodium 12.5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
161568|NCT01706588|O1|Outcome|Diclofenac Sodium 5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
161569|NCT01706588|E5|Reported Event|Placebo 1 mL|One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
161570|NCT01706588|E4|Reported Event|Diclofenac Sodium 50 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
161571|NCT01706588|E3|Reported Event|Diclofenac Sodium 25 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
161572|NCT01706588|E2|Reported Event|Diclofenac Sodium 12.5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
161573|NCT01706588|E1|Reported Event|Diclofenac Sodium 5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
161574|NCT01706575|B1|Baseline|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
161575|NCT01706575|P1|Participant Flow|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
161576|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
161577|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
161578|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
161579|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
161580|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
161581|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
161582|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
161632|NCT01706536|O4|Outcome|EP-101 50 mcg|"EP-101 50 mcg AM + EP-101 50 mcg PM~EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM"
161633|NCT01706536|O3|Outcome|EP-101 25 mcg|"EP-101 25 mcg AM + EP-101 25 mcg PM~EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM"
161583|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
161584|NCT01706575|E1|Reported Event|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
161585|NCT01706549|B1|Baseline|Postoperative Pain|Observational study on posthysterectomy pain
161586|NCT01706549|P1|Participant Flow|Posthysterectomy Pain|Observational study on posthysterectomy pain. Participants recruited from previous studies. Recruitment completed.
161587|NCT01706549|O1|Outcome|Posthysterectomy Pain|Observational study on posthysterectomy pain. Participants recruited from previous studies. Recruitment completed.
161588|NCT01706549|O1|Outcome|Posthysterectomy Pain|Observational study on posthysterectomy pain. Participants recruited from previous studies. Recruitment completed.
161589|NCT01706549|E1|Reported Event|Posthysterectomy Pain|This was an observational study, thus no adverse events were collected.
161590|NCT01706536|B6|Baseline|Total|Total of all reporting groups
161591|NCT01706536|B5|Baseline|EP-101 100 mcg|"EP-101 100 mcg AM + EP-101 100 mcg PM~EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM"
161592|NCT01706536|B4|Baseline|EP-101 50 mcg|"EP-101 50 mcg AM + EP-101 50 mcg PM~EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM"
161593|NCT01706536|B3|Baseline|EP-101 25 mcg|"EP-101 25 mcg AM + EP-101 25 mcg PM~EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM"
161594|NCT01706536|B2|Baseline|EP 101 12.5 mcg|"EP-101 12.5 mcg AM + EP-101 12.5 mcg PM~EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM"
161595|NCT01706536|B1|Baseline|Placebo|"Placebo AM + Placebo PM~Placebo:AM +Placebo PM"
161596|NCT01706536|P5|Participant Flow|EP-101 100 mcg|"EP-101 100 mcg AM + EP-101 100 mcg PM~EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM"
161597|NCT01706536|P4|Participant Flow|EP-101 50 mcg|"EP-101 50 mcg AM + EP-101 50 mcg PM~EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM"
161598|NCT01706536|P3|Participant Flow|EP-101 25 mcg|"EP-101 25 mcg AM + EP-101 25 mcg PM~EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM"
161599|NCT01706536|P2|Participant Flow|EP 101 12.5 mcg|"EP-101 12.5 mcg AM + EP-101 12.5 mcg PM~EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM"
161600|NCT01706536|P1|Participant Flow|Placebo|"Placebo AM + Placebo PM~Placebo:AM +Placebo PM"
161601|NCT01706536|O5|Outcome|EP-101 100 mcg|"EP-101 100 mcg AM + EP-101 100 mcg PM~EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM"
161602|NCT01706536|O4|Outcome|EP-101 50 mcg|"EP-101 50 mcg AM + EP-101 50 mcg PM~EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM"
161603|NCT01706536|O3|Outcome|EP-101 25 mcg|"EP-101 25 mcg AM + EP-101 25 mcg PM~EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM"
161604|NCT01706536|O2|Outcome|EP 101 12.5 mcg|"EP-101 12.5 mcg AM + EP-101 12.5 mcg PM~EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM"
161605|NCT01706536|O1|Outcome|Placebo|"Placebo AM + Placebo PM~Placebo:AM +Placebo PM"
161606|NCT01706536|O5|Outcome|EP-101 100 mcg|"EP-101 100 mcg AM + EP-101 100 mcg PM~EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM"
161607|NCT01706536|O4|Outcome|EP-101 50 mcg|"EP-101 50 mcg AM + EP-101 50 mcg PM~EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM"
161608|NCT01706536|O3|Outcome|EP-101 25 mcg|"EP-101 25 mcg AM + EP-101 25 mcg PM~EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM"
161609|NCT01706536|O2|Outcome|EP 101 12.5 mcg|"EP-101 12.5 mcg AM + EP-101 12.5 mcg PM~EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM"
161610|NCT01706536|O1|Outcome|Placebo|"Placebo AM + Placebo PM~Placebo:AM +Placebo PM"
161611|NCT01706536|O5|Outcome|EP-101 100 mcg|"EP-101 100 mcg AM + EP-101 100 mcg PM~EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM"
161612|NCT01706536|O4|Outcome|EP-101 50 mcg|"EP-101 50 mcg AM + EP-101 50 mcg PM~EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM"
161613|NCT01706536|O3|Outcome|EP-101 25 mcg|"EP-101 25 mcg AM + EP-101 25 mcg PM~EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM"
161614|NCT01706536|O2|Outcome|EP 101 12.5 mcg|"EP-101 12.5 mcg AM + EP-101 12.5 mcg PM~EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM"
161615|NCT01706536|O1|Outcome|Placebo|"Placebo AM + Placebo PM~Placebo:AM +Placebo PM"
161616|NCT01706536|O5|Outcome|EP-101 100 mcg|"EP-101 100 mcg AM + EP-101 100 mcg PM~EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM"
161617|NCT01706536|O4|Outcome|EP-101 50 mcg|"EP-101 50 mcg AM + EP-101 50 mcg PM~EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM"
161618|NCT01706536|O3|Outcome|EP-101 25 mcg|"EP-101 25 mcg AM + EP-101 25 mcg PM~EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM"
161619|NCT01706536|O2|Outcome|EP 101 12.5 mcg|"EP-101 12.5 mcg AM + EP-101 12.5 mcg PM~EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM"
161620|NCT01706536|O1|Outcome|Placebo|"Placebo AM + Placebo PM~Placebo:AM +Placebo PM"
161621|NCT01706536|O5|Outcome|EP-101 100 mcg|"EP-101 100 mcg AM + EP-101 100 mcg PM~EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM"
161622|NCT01706536|O4|Outcome|EP-101 50 mcg|"EP-101 50 mcg AM + EP-101 50 mcg PM~EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM"
161623|NCT01706536|O3|Outcome|EP-101 25 mcg|"EP-101 25 mcg AM + EP-101 25 mcg PM~EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM"
161624|NCT01706536|O2|Outcome|EP 101 12.5 mcg|"EP-101 12.5 mcg AM + EP-101 12.5 mcg PM~EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM"
161625|NCT01706536|O1|Outcome|Placebo|"Placebo AM + Placebo PM~Placebo:AM +Placebo PM"
161626|NCT01706536|O5|Outcome|EP-101 100 mcg|"EP-101 100 mcg AM + EP-101 100 mcg PM~EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM"
161627|NCT01706536|O4|Outcome|EP-101 50 mcg|"EP-101 50 mcg AM + EP-101 50 mcg PM~EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM"
161628|NCT01706536|O3|Outcome|EP-101 25 mcg|"EP-101 25 mcg AM + EP-101 25 mcg PM~EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM"
161629|NCT01706536|O2|Outcome|EP 101 12.5 mcg|"EP-101 12.5 mcg AM + EP-101 12.5 mcg PM~EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM"
161630|NCT01706536|O1|Outcome|Placebo|"Placebo AM + Placebo PM~Placebo:AM +Placebo PM"
161631|NCT01706536|O5|Outcome|EP-101 100 mcg|"EP-101 100 mcg AM + EP-101 100 mcg PM~EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM"
161634|NCT01706536|O2|Outcome|EP 101 12.5 mcg|"EP-101 12.5 mcg AM + EP-101 12.5 mcg PM~EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM"
161635|NCT01706536|O1|Outcome|Placebo|"Placebo AM + Placebo PM~Placebo:AM +Placebo PM"
161636|NCT01706536|O5|Outcome|EP-101 100 mcg|"EP-101 100 mcg AM + EP-101 100 mcg PM~EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM"
161637|NCT01706536|O4|Outcome|EP-101 50 mcg|"EP-101 50 mcg AM + EP-101 50 mcg PM~EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM"
161638|NCT01706536|O3|Outcome|EP-101 25 mcg|"EP-101 25 mcg AM + EP-101 25 mcg PM~EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM"
161639|NCT01706536|O2|Outcome|EP 101 12.5 mcg|"EP-101 12.5 mcg AM + EP-101 12.5 mcg PM~EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM"
161640|NCT01706536|O1|Outcome|Placebo|"Placebo AM + Placebo PM~Placebo:AM +Placebo PM"
161641|NCT01706536|O5|Outcome|EP-101 100 mcg|"EP-101 100 mcg AM + EP-101 100 mcg PM~EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM"
161642|NCT01706536|O4|Outcome|EP-101 50 mcg|"EP-101 50 mcg AM + EP-101 50 mcg PM~EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM"
161643|NCT01706536|O3|Outcome|EP-101 25 mcg|"EP-101 25 mcg AM + EP-101 25 mcg PM~EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM"
161644|NCT01706536|O2|Outcome|EP 101 12.5 mcg|"EP-101 12.5 mcg AM + EP-101 12.5 mcg PM~EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM"
161645|NCT01706536|O1|Outcome|Placebo|"Placebo AM + Placebo PM~Placebo AM + Placebo PM"
161646|NCT01706536|O5|Outcome|EP-101 100 mcg|"EP-101 100 mcg AM + EP-101 100 mcg PM~EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM"
161647|NCT01706536|O4|Outcome|EP-101 50 mcg|"EP-101 50 mcg AM + EP-101 50 mcg PM~EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM"
161648|NCT01706536|O3|Outcome|EP-101 25 mcg|"EP-101 25 mcg AM + EP-101 25 mcg PM~EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM"
161649|NCT01706536|O2|Outcome|EP 101 12.5 mcg|"EP-101 12.5 mcg AM + EP-101 12.5 mcg PM~EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM"
161650|NCT01706536|O1|Outcome|Placebo|"Placebo AM + Placebo PM~Placebo:AM +Placebo PM"
161651|NCT01706536|E5|Reported Event|EP-101 100 mcg|"EP-101 100 mcg AM + EP-101 100 mcg PM~EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM"
161652|NCT01706536|E4|Reported Event|EP-101 50 mcg|"EP-101 50 mcg AM + EP-101 50 mcg PM~EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM"
161653|NCT01706536|E3|Reported Event|EP-101 25 mcg|"EP-101 25 mcg AM + EP-101 25 mcg PM~EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM"
161654|NCT01706536|E2|Reported Event|EP 101 12.5 mcg|"EP-101 12.5 mcg AM + EP-101 12.5 mcg PM~EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM"
161655|NCT01706536|E1|Reported Event|Placebo|"Placebo AM + Placebo PM~Placebo AM + Placebo PM"
161656|NCT01706328|B3|Baseline|Total|Total of all reporting groups
161657|NCT01706328|B2|Baseline|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
161658|NCT01706328|B1|Baseline|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
161659|NCT01706328|P3|Participant Flow|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
161660|NCT01706328|P2|Participant Flow|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
161661|NCT01706328|P1|Participant Flow|Placebo + Salbutamol|Participants were instructed to take single-blind placebo twice a day (one inhalation from a multi-dose powder inhaler [MPI] and one inhalation from a dry powder inhaler [DPI] in the morning; one inhalation from an MPI in the evening). In addition, all participants received supplemental albuterol (salbutamol) (via a metered dose inhaler [MDI] and/or nebules) to be used on an as-needed basis. Ipratropium bromide alone was permitted, provided that the participant was on a stable dose from Visit 1 (Screening) and remained on the stable dose throughout the study; however, ipratropium must have been withheld for 4 hours prior to and during each clinic visit.
161662|NCT01706328|O2|Outcome|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
161663|NCT01706328|O1|Outcome|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
161664|NCT01706328|O2|Outcome|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
161665|NCT01706328|O1|Outcome|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
161724|NCT01706159|E1|Reported Event|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
161666|NCT01706328|O2|Outcome|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
161667|NCT01706328|O1|Outcome|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
161668|NCT01706328|E2|Reported Event|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
161669|NCT01706328|E1|Reported Event|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
161670|NCT01706263|B1|Baseline|MAXCLARITY II|The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
161671|NCT01706263|P1|Participant Flow|MAXCLARITY II|The eligible participants applied a small amount of the MAXCLARITY II™ 2.5 percent (%) benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
161672|NCT01706263|O1|Outcome|MAXCLARITY II|The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
161673|NCT01706263|O1|Outcome|MAXCLARITY II|The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
161674|NCT01706263|O1|Outcome|MAXCLARITY II|The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule..
161675|NCT01706263|O1|Outcome|MAXCLARITY II|The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
161676|NCT01706263|O1|Outcome|MAXCLARITY II|The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
161725|NCT01706146|B1|Baseline|Non-Coumadin Oral Anticoagulant|"Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.~Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device."
161677|NCT01706263|O1|Outcome|MAXCLARITY II|The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
161678|NCT01706263|E1|Reported Event|MAXCLARITY II|The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
161679|NCT01706250|B1|Baseline|MAXCLARITY II + PROACTIV|This was a split face study, wherein the participants, each morning washed their face with MaxClarity II foam cleanser on 1 side of the face and Proactive renewing cleanser on the other side of the face. The face was patted dry the MaxClarity II foam treatment was applied to the MaxClarity II side of the face and on the proactive side, the participant applied the Revitalizing toner and then the Repairing lotion. The same was repeated in the evening, where the participants washed their face with MaxClarity II foam cleanser on 1 side and Proactiv renewing cleanser on the other side of the face. On the Proactiv side, the participant will apply the Revitalizing toner and then the Repairing lotion.
161680|NCT01706250|P1|Participant Flow|MAXCLARITY II + PROACTIV|This was a split face study, wherein the participants, each morning washed their face with MaxClarity II foam cleanser on 1 side of the face and Proactive renewing cleanser on the other side of the face. The face was patted dry the MaxClarity II foam treatment was applied to the MaxClarity II side of the face and on the proactive side, the participant applied the Revitalizing toner and then the Repairing lotion. The same was repeated in the evening, where the participants washed their face with MaxClarity II foam cleanser on 1 side and Proactiv renewing cleanser on the other side of the face. On the Proactiv side, the participant will apply the Revitalizing toner and then the Repairing lotion.
161681|NCT01706250|O2|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
161682|NCT01706250|O1|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
161683|NCT01706250|O2|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
161684|NCT01706250|O1|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
161685|NCT01706250|O2|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
161686|NCT01706250|O1|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
161687|NCT01706250|O2|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
161688|NCT01706250|O1|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
161689|NCT01706250|O2|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
161690|NCT01706250|O1|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
161691|NCT01706250|O2|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
161692|NCT01706250|O1|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
161693|NCT01706250|O2|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
161694|NCT01706250|O1|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
161695|NCT01706250|O2|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wk, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
161696|NCT01706250|O1|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-weeks (Wk). The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
161697|NCT01706250|O2|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
161698|NCT01706250|O1|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
161699|NCT01706250|O2|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
161700|NCT01706250|O1|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
161701|NCT01706250|O2|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
161750|NCT01705652|B1|Baseline|Nexrutine Surgery Group|Surgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery. Minimum of 30 days and maximum of 80 days before surgery. The final dose is taken the day before surgery.
161702|NCT01706250|O1|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
161703|NCT01706250|O2|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wk, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
161704|NCT01706250|O1|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wk. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
161705|NCT01706250|O2|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wk, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
161706|NCT01706250|O1|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% benzyl peroxide [BPO]) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (the side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
161707|NCT01706250|E1|Reported Event|MAXCLARITY II + PROACTIV|This was a split face study, wherein the participants, each morning washed their face with MaxClarity II foam cleanser on 1 side of the face and Proactive renewing cleanser on the other side of the face. The face was patted dry the MaxClarity II foam treatment was applied to the MaxClarity II side of the face and on the proactive side, the participant applied the Revitalizing toner and then the Repairing lotion. The same was repeated in the evening, where the participants washed their face with MaxClarity II foam cleanser on 1 side and Proactiv renewing cleanser on the other side of the face. On the Proactiv side, the participant will apply the Revitalizing toner and then the Repairing lotion.
161708|NCT01706159|B3|Baseline|Total|Total of all reporting groups
161709|NCT01706159|B2|Baseline|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
161710|NCT01706159|B1|Baseline|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
161711|NCT01706159|P2|Participant Flow|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
161712|NCT01706159|P1|Participant Flow|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
161713|NCT01706159|O2|Outcome|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
161714|NCT01706159|O1|Outcome|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
161715|NCT01706159|O2|Outcome|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
161716|NCT01706159|O1|Outcome|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
161717|NCT01706159|O2|Outcome|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
161718|NCT01706159|O1|Outcome|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
161719|NCT01706159|O2|Outcome|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
161720|NCT01706159|O1|Outcome|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
161721|NCT01706159|O2|Outcome|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
161722|NCT01706159|O1|Outcome|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
161723|NCT01706159|E2|Reported Event|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
162038|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
161726|NCT01706146|P1|Participant Flow|Non-Coumadin Oral Anticoagulant|"Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.~Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device."
161727|NCT01706146|O1|Outcome|Non-Coumadin Oral Anticoagulant|"Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.~Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device."
161728|NCT01706146|O1|Outcome|Non-Coumadin Oral Anticoagulant|"Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.~Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device."
161729|NCT01706146|E1|Reported Event|Non-Coumadin Oral Anticoagulant|"Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.~Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device."
161730|NCT01705717|B3|Baseline|Total|Total of all reporting groups
161731|NCT01705717|B2|Baseline|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
161732|NCT01705717|B1|Baseline|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
161733|NCT01705717|P2|Participant Flow|Hepatitis C Virus (HCV) – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
161734|NCT01705717|P1|Participant Flow|Non-Cirrhotic Chronic Hepatitis C (CHC) Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
161735|NCT01705717|O2|Outcome|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
161736|NCT01705717|O1|Outcome|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
161737|NCT01705717|O2|Outcome|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
161738|NCT01705717|O1|Outcome|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
161739|NCT01705717|O2|Outcome|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
161740|NCT01705717|O1|Outcome|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
161741|NCT01705717|O2|Outcome|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
161742|NCT01705717|O1|Outcome|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
161743|NCT01705717|O2|Outcome|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
161744|NCT01705717|O1|Outcome|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
161745|NCT01705717|O2|Outcome|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
161746|NCT01705717|O1|Outcome|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
161747|NCT01705717|E1|Reported Event|All Participants|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC or HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
161748|NCT01705652|B3|Baseline|Total|Total of all reporting groups
161749|NCT01705652|B2|Baseline|Nexrutine Radiation Group|Radiation Group: Nexrutine 500mg by mouth, three times per day, given prior to and during radiation treatment. Minimum of 30 days and maximum of 60 days prior to the start of radiation therapy and then during treatment. The final dose is taken the last day of radiation.
161751|NCT01705652|P2|Participant Flow|Nexrutine Radiation Group|Radiation Group: Nexrutine 500mg by mouth, three times per day, given prior to and during radiation treatment.
161752|NCT01705652|P1|Participant Flow|Nexrutine Surgery Group|Surgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery.
161753|NCT01705652|O2|Outcome|Surgery Group|Nexrutine by mouth three times per day prior to surgery for a minimum of 30 days and maximum of 80 days. The final dose is taken the day before surgery.
161754|NCT01705652|O1|Outcome|Radiation Group|Nexrutine by mouth three times per day for a minimum of 30 days and a maximum of 60 days prior to the start of radiation therapy and during treatment. The final dose will be taken the last day of radiation.
161755|NCT01705652|E2|Reported Event|Nexrutine Radiation Group|Radiation Group: Nexrutine 500mg by mouth, three times per day, given prior to and during radiation treatment.
161756|NCT01705652|E1|Reported Event|Nexrutine Surgery Group|Surgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery.
161757|NCT01705587|B3|Baseline|Total|Total of all reporting groups
161758|NCT01705587|B2|Baseline|Delayed Teriparatide|"Open label teriparatide given six months following surgical repair of fracture~teriparatide: 20 microgram once-daily subcutaneous injection"
161759|NCT01705587|B1|Baseline|Immediate Teriparatide|"Open label teriparatide given immediately following surgical repair of fracture~teriparatide: 20 microgram once-daily subcutaneous injection"
161760|NCT01705587|P2|Participant Flow|Delayed Teriparatide|"Open label teriparatide given six months following surgical repair of fracture~teriparatide: 20 microgram once-daily subcutaneous injection"
161761|NCT01705587|P1|Participant Flow|Immediate Teriparatide|"Open label teriparatide given immediately following surgical repair of fracture~teriparatide: 20 microgram once-daily subcutaneous injection"
161762|NCT01705587|O2|Outcome|Delayed Teriparatide|"Open label teriparatide given six months following surgical repair of fracture~teriparatide: 20 microgram once-daily subcutaneous injection"
161763|NCT01705587|O1|Outcome|Immediate Teriparatide|"Open label teriparatide given immediately following surgical repair of fracture~teriparatide: 20 microgram once-daily subcutaneous injection"
161764|NCT01705587|O2|Outcome|Delayed Teriparatide|"Open label teriparatide given six months following surgical repair of fracture~teriparatide: 20 microgram once-daily subcutaneous injection"
161765|NCT01705587|O1|Outcome|Immediate Teriparatide|"Open label teriparatide given immediately following surgical repair of fracture~teriparatide: 20 microgram once-daily subcutaneous injection"
161766|NCT01705587|O2|Outcome|Delayed Teriparatide|"Open label teriparatide given six months following surgical repair of fracture~teriparatide: 20 microgram once-daily subcutaneous injection"
161767|NCT01705587|O1|Outcome|Immediate Teriparatide|"Open label teriparatide given immediately following surgical repair of fracture~teriparatide: 20 microgram once-daily subcutaneous injection"
161768|NCT01705587|O2|Outcome|Delayed Teriparatide|"Open label teriparatide given six months following surgical repair of fracture~teriparatide: 20 microgram once-daily subcutaneous injection"
161769|NCT01705587|O1|Outcome|Immediate Teriparatide|"Open label teriparatide given immediately following surgical repair of fracture~teriparatide: 20 microgram once-daily subcutaneous injection"
161770|NCT01705587|O2|Outcome|Delayed Teriparatide|"Open label teriparatide given six months following surgical repair of fracture~teriparatide: 20 microgram once-daily subcutaneous injection"
161771|NCT01705587|O1|Outcome|Immediate Teriparatide|"Open label teriparatide given immediately following surgical repair of fracture~teriparatide: 20 microgram once-daily subcutaneous injection"
161772|NCT01705587|O2|Outcome|Delayed Teriparatide|"Open label teriparatide given six months following surgical repair of fracture~teriparatide: 20 microgram once-daily subcutaneous injection"
161773|NCT01705587|O1|Outcome|Immediate Teriparatide|"Open label teriparatide given immediately following surgical repair of fracture~teriparatide: 20 microgram once-daily subcutaneous injection"
161774|NCT01705587|E2|Reported Event|Delayed Teriparatide|"Open label teriparatide given six months following surgical repair of fracture~teriparatide: 20 microgram once-daily subcutaneous injection"
161775|NCT01705587|E1|Reported Event|Immediate Teriparatide|"Open label teriparatide given immediately following surgical repair of fracture~teriparatide: 20 microgram once-daily subcutaneous injection"
161776|NCT01705574|B3|Baseline|Total|Total of all reporting groups
161777|NCT01705574|B2|Baseline|ATV+RTV+FTC/TDF|Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + FTC/TDF (200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
161778|NCT01705574|B1|Baseline|E/C/F/TDF|Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC + ATV placebo + RTV placebo + FTC/TDF placebo once daily for 48 weeks
161779|NCT01705574|P2|Participant Flow|ATV+RTV+FTC/TDF|Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + FTC/TDF (Truvada®; 200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
161780|NCT01705574|P1|Participant Flow|E/C/F/TDF|Double-Blind Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) (150/150/200/300 mg) fixed-dose combination (FDC) + atazanavir (ATV) placebo + ritonavir (RTV) placebo + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo once daily for 48 weeks
161781|NCT01705574|O2|Outcome|ATV+RTV+FTC/TDF|Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + FTC/TDF (200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
161782|NCT01705574|O1|Outcome|E/C/F/TDF|Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC + ATV placebo + RTV placebo + FTC/TDF placebo once daily for 48 weeks
161783|NCT01705574|O2|Outcome|ATV+RTV+FTC/TDF|Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + FTC/TDF (200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
161784|NCT01705574|O1|Outcome|E/C/F/TDF|Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC + ATV placebo + RTV placebo + FTC/TDF placebo once daily for 48 weeks
161785|NCT01705574|E2|Reported Event|ATV+RTV+FTC/TDF|Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + FTC/TDF (200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
161786|NCT01705574|E1|Reported Event|E/C/F/TDF|Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC + ATV placebo + RTV placebo + FTC/TDF placebo once daily for 48 weeks
161787|NCT01705496|B1|Baseline|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
161788|NCT01705496|P1|Participant Flow|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
161789|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
161790|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
161791|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
161792|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
161793|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
161794|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
161795|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
161796|NCT01705496|E1|Reported Event|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
161797|NCT01705145|B1|Baseline|Ivacaftor|"Part A: Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.~Part B: Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants."
161798|NCT01705145|P1|Participant Flow|Ivacaftor|"Part A: Ivacaftor 50 milligram (mg) (for participants weighing less than [<] 14 kilograms [kg]) or 75 mg (for participants weighing greater than or equal to [>=] 14 kg) every 12 hours (q12h) from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.~Part B: Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants."
161799|NCT01705145|O3|Outcome|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
161800|NCT01705145|O2|Outcome|Part B: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
161801|NCT01705145|O1|Outcome|Part B: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
161802|NCT01705145|O1|Outcome|Part A: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
161803|NCT01705145|O3|Outcome|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
161804|NCT01705145|O2|Outcome|Part B: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
161805|NCT01705145|O1|Outcome|Part B: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
161806|NCT01705145|O3|Outcome|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
161807|NCT01705145|O2|Outcome|Part B: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
161808|NCT01705145|O1|Outcome|Part B: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
161809|NCT01705145|O3|Outcome|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
161810|NCT01705145|O2|Outcome|Part B: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
183469|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
161811|NCT01705145|O1|Outcome|Part B: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
161812|NCT01705145|O1|Outcome|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
161813|NCT01705145|O3|Outcome|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
161814|NCT01705145|O2|Outcome|Part B: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
161815|NCT01705145|O1|Outcome|Part B: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
161816|NCT01705145|O3|Outcome|Part A: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
161817|NCT01705145|O2|Outcome|Part A: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
161818|NCT01705145|O1|Outcome|Part A: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
161819|NCT01705145|E6|Reported Event|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
161820|NCT01705145|E5|Reported Event|Part B: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
161821|NCT01705145|E4|Reported Event|Part B: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
161822|NCT01705145|E3|Reported Event|Part A: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
161823|NCT01705145|E2|Reported Event|Part A: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
161824|NCT01705145|E1|Reported Event|Part A: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
161825|NCT01705106|B1|Baseline|Treatment (Capecitabine, Celecoxib)|"Patients receive celecoxib PO BID for 7 days (course 0) and then on days 1-21 of course 1 and all subsequent courses. Patients also receive capecitabine PO BID on days 1-14 beginning in course 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~capecitabine: Given PO~celecoxib: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~pharmacogenomic studies: Correlative studies"
161826|NCT01705106|P1|Participant Flow|Treatment (Capecitabine, Celecoxib)|"Patients receive celecoxib PO BID for 7 days (course 0) and then on days 1-21 of course 1 and all subsequent courses. Patients also receive capecitabine PO BID on days 1-14 beginning in course 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~capecitabine: Given PO~celecoxib: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~pharmacogenomic studies: Correlative studies"
161827|NCT01705106|O1|Outcome|Treatment (Capecitabine, Celecoxib)|"Patients receive celecoxib PO BID for 7 days (course 0) and then on days 1-21 of course 1 and all subsequent courses. Patients also receive capecitabine PO BID on days 1-14 beginning in course 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~capecitabine: Given PO~celecoxib: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~pharmacogenomic studies: Correlative studies"
161828|NCT01705106|O1|Outcome|Treatment (Capecitabine, Celecoxib)|"Patients receive celecoxib PO BID for 7 days (course 0) and then on days 1-21 of course 1 and all subsequent courses. Patients also receive capecitabine PO BID on days 1-14 beginning in course 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~capecitabine: Given PO~celecoxib: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~pharmacogenomic studies: Correlative studies"
161829|NCT01705106|O1|Outcome|Treatment (Capecitabine, Celecoxib)|"Patients receive celecoxib PO BID for 7 days (course 0) and then on days 1-21 of course 1 and all subsequent courses. Patients also receive capecitabine PO BID on days 1-14 beginning in course 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~capecitabine: Given PO~celecoxib: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~pharmacogenomic studies: Correlative studies"
161830|NCT01705106|O1|Outcome|Treatment (Capecitabine, Celecoxib)|"Patients receive celecoxib PO BID for 7 days (course 0) and then on days 1-21 of course 1 and all subsequent courses. Patients also receive capecitabine PO BID on days 1-14 beginning in course 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~capecitabine: Given PO~celecoxib: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~pharmacogenomic studies: Correlative studies"
161831|NCT01705106|O1|Outcome|Treatment (Capecitabine, Celecoxib)|"Patients receive celecoxib PO BID for 7 days (course 0) and then on days 1-21 of course 1 and all subsequent courses. Patients also receive capecitabine PO BID on days 1-14 beginning in course 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~capecitabine: Given PO~celecoxib: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~pharmacogenomic studies: Correlative studies"
161860|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
162039|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
161832|NCT01705106|E1|Reported Event|Treatment (Capecitabine, Celecoxib)|"Patients receive celecoxib PO BID for 7 days (course 0) and then on days 1-21 of course 1 and all subsequent courses. Patients also receive capecitabine PO BID on days 1-14 beginning in course 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~capecitabine: Given PO~celecoxib: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~pharmacogenomic studies: Correlative studies"
161833|NCT01704976|B3|Baseline|Total|Total of all reporting groups
161834|NCT01704976|B2|Baseline|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
161835|NCT01704976|B1|Baseline|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
161836|NCT01704976|P2|Participant Flow|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
161837|NCT01704976|P1|Participant Flow|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
161838|NCT01704976|O2|Outcome|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
161839|NCT01704976|O1|Outcome|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
161840|NCT01704976|O2|Outcome|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
161841|NCT01704976|O1|Outcome|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
161842|NCT01704976|O2|Outcome|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
161843|NCT01704976|O1|Outcome|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
161844|NCT01704976|O2|Outcome|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
161845|NCT01704976|O1|Outcome|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
161846|NCT01704976|O2|Outcome|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
161847|NCT01704976|O1|Outcome|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
161848|NCT01704976|E2|Reported Event|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
161849|NCT01704976|E1|Reported Event|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
161850|NCT01704846|B3|Baseline|Total|Total of all reporting groups
161851|NCT01704846|B2|Baseline|Treatment Sequence 2|"Treatment sequence: Reference - Test - Test - Reference~Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.~Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.~Treatments were separated by a washout period of at least 14 days."
161852|NCT01704846|B1|Baseline|Treatment Sequence 1|"Treatment sequence: Test - Reference - Reference - Test~Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.~Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.~Treatments were separated by a washout period of at least 14 days."
161853|NCT01704846|P2|Participant Flow|Treatment Sequence 2|"Treatment sequence: Reference - Test - Test - Reference~Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.~Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.~Treatments were separated by a washout period of at least 14 days."
161854|NCT01704846|P1|Participant Flow|Treatment Sequence 1|"Treatment sequence: Test - Reference - Reference - Test~Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.~Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.~Treatments were separated by a washout period of at least 14 days."
161855|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
161856|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
161857|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
161858|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
161859|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
161906|NCT01704755|B3|Baseline|Total|Total of all reporting groups
161861|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
161862|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
161863|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
161864|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
161865|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
161866|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
161867|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
161868|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
161869|NCT01704846|E2|Reported Event|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
161870|NCT01704846|E1|Reported Event|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
161871|NCT01704781|B6|Baseline|Total|Total of all reporting groups
161872|NCT01704781|B5|Baseline|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.~Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
161873|NCT01704781|B4|Baseline|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.~Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
161874|NCT01704781|B3|Baseline|Part A: Lenalidopmide 25 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg
161875|NCT01704781|B2|Baseline|Part A: Lenalidomide 10 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg
161876|NCT01704781|B1|Baseline|Part A: Lenalidomide 5 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg
161877|NCT01704781|P5|Participant Flow|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.~Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
161878|NCT01704781|P4|Participant Flow|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.~Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
161879|NCT01704781|P3|Participant Flow|Part A: Lenalidopmide 25 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg
161880|NCT01704781|P2|Participant Flow|Part A: Lenalidomide 10 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg
161881|NCT01704781|P1|Participant Flow|Part A: Lenalidomide 5 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg
161882|NCT01704781|O5|Outcome|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.~Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
161883|NCT01704781|O4|Outcome|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.~Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
161884|NCT01704781|O3|Outcome|Part A: Lenalidopmide 25 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg
161885|NCT01704781|O2|Outcome|Part A: Lenalidomide 10 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg
161886|NCT01704781|O1|Outcome|Part A: Lenalidomide 5 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg
162006|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
161887|NCT01704781|O2|Outcome|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.~Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
161888|NCT01704781|O1|Outcome|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.~Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
161889|NCT01704781|O2|Outcome|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.~Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
161890|NCT01704781|O1|Outcome|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.~Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
161891|NCT01704781|O2|Outcome|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.~Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
161892|NCT01704781|O1|Outcome|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.~Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
161893|NCT01704781|O2|Outcome|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.~Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
161894|NCT01704781|O1|Outcome|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.~Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
161895|NCT01704781|O3|Outcome|Part A: Lenalidopmide 25 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg
161896|NCT01704781|O2|Outcome|Part A: Lenalidomide 10 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg
161897|NCT01704781|O1|Outcome|Part A: Lenalidomide 5 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg
161898|NCT01704781|O3|Outcome|Part A: Lenalidopmide 25 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg
161899|NCT01704781|O2|Outcome|Part A: Lenalidomide 10 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg
161900|NCT01704781|O1|Outcome|Part A: Lenalidomide 5 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg
161901|NCT01704781|E5|Reported Event|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.~Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
161902|NCT01704781|E4|Reported Event|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.~Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
161903|NCT01704781|E3|Reported Event|Part A: Lenalidopmide 25 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg
161904|NCT01704781|E2|Reported Event|Part A: Lenalidomide 10 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg
161905|NCT01704781|E1|Reported Event|Part A: Lenalidomide 5 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg
161907|NCT01704755|B2|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
161908|NCT01704755|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
161909|NCT01704755|P2|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
161910|NCT01704755|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
161911|NCT01704755|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
161912|NCT01704755|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
161913|NCT01704755|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
161914|NCT01704755|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
161915|NCT01704755|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
161916|NCT01704755|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
161917|NCT01704755|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
161918|NCT01704755|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
161919|NCT01704755|E2|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
161920|NCT01704755|E1|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
161921|NCT01704651|B3|Baseline|Total|Total of all reporting groups
161922|NCT01704651|B2|Baseline|Placebo|Perioperative administration of placebo, at same dosing interval as study drug.
161923|NCT01704651|B1|Baseline|Alvimopan|Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
161924|NCT01704651|P2|Participant Flow|Placebo|Perioperative administration of placebo, at same dosing interval as study drug.
161925|NCT01704651|P1|Participant Flow|Alvimopan|Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
161926|NCT01704651|O2|Outcome|Placebo|Perioperative administration of placebo, at same dosing interval as study drug.
161927|NCT01704651|O1|Outcome|Alvimopan|Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
161928|NCT01704651|O2|Outcome|Placebo|Perioperative administration of placebo, at same dosing interval as study drug.
161929|NCT01704651|O1|Outcome|Alvimopan|Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
161930|NCT01704651|E2|Reported Event|Placebo|Perioperative administration of oral placebo, at same dosing interval as study drug, starting with one dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days..
161931|NCT01704651|E1|Reported Event|Alvimopan|Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
161932|NCT01704599|B1|Baseline|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins~The only arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks. At end of this therapy can stop or continue . Telephone call day 70 after formal end of in person study the investigators will assess general health of each subject.~Humira Then Humira plus 3 B vitamins: Humira alone for 16 weeks then Humira plus 100 mg daily pyridoxine, 5 mg daily folic acid and 1000 mcg daily cyanocobalamin"
161933|NCT01704599|P1|Participant Flow|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins~The one arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks. At end of this, therapy can stop or continue . Telephone call day 70 after formal end of in person study the investigators will assess general health of each subject.~Humira Then Humira plus 3 B vitamins: Humira alone for 16 weeks then Humira plus 100 mg daily pyridoxine, 5 mg daily folic acid and 1000 mcg daily cyanocobalamin"
162172|NCT01704404|O2|Outcome|Dose 2 TD-4208|"44 µg~TD-4208"
161934|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins~The one arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks (week 28)."
161935|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins~The one arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks. At end of this, therapy can stop or continue . Telephone call day 70 after formal end of in person study the investigators will assess general health of each subject."
161936|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins~The one arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks."
161937|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins~The only arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks. At end of this therapy can stop or continue. Telephone call day 70 after formal end of in person study the investigators will assess general health of each subject.~Humira Then Humira plus 3 B vitamins: Humira alone for 16 weeks then Humira plus 100 mg daily pyridoxine, 5 mg daily folic acid and 1000 mcg daily cyanocobalamin"
161938|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|8 adults ages 18-65 with moderate to severe plaque psoriasis with PASI measured week 0 on no systemic psoriasis medication, weeks 4 and 16 after 4 and 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab plus 12 weeks of adalimumab and 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12 ranked by calculated Body Mass Index (BMI) week 0.
161939|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 years with moderate to severe plaque psoriasis. Weight measurement were in pounds measured at Weeks 16 and 28.
161940|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|8 adults age 18-65 yearswith moderate to severe plaque psoriasis measured at week 0 of study on no systemic psoriasis medication.
161941|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Temperature measurements in adults ages 18-65 with moderate to severe plaque psoriasis at week16 on adalimuamb and week 28 temperatures on adalimumab and daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12.
161942|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Subjects were adults with moderate to severe plaque psoriasis with test to be measured week 0 on no systemic psoriasis medication, week 16 after 16 weeks adalimumab and week 28 after 16 weeks adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of vitamin B12.
161943|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|One adult psoriasis subject age 23 with moderate to severe plaque psoriasis with pregnanacy test on enrollment on no systemic psoriasis therapy.
161944|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|8 adults ages18-65 with moderate to severe plaque psoriasis tested at week 0 on no systemic psoriasis therapy; week 16 after 16 weeks of adalimumab and week 28 after 16 weeks adalimumab plus 5 mg folic acid, 100 mg B6 and 1000 mcg B12.
161945|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 with moderate to severe plaque psoriasis measured at 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab and daily 5 mg folic acid 100 mg vitamin B6 and 1000 mcg B12.
161946|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults 18-65 years with moderate to severe plaque psoriasis measured at week 16 after 16 weeks adalimumab and week 28 after 28 weeks adalimumab annd 12 weeks on adalimumab, folic acid 5 mg, 100 mg B6 and 1000 mcg B12.
161947|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 with moderate to severe plaque psoriasis.
161948|NCT01704599|O1|Outcome|Humira Plus 3 B Vitamins|adults 18-65 with plaque psoriasis (moderate to severe) measured at week 0 on no systemic psoriasis medication; week 16 after 16 weeks adalimumab and at 28 weeks after 16 weeks adalimumab plus 12 weeks folic acid, vitamin B6 and B12.
161949|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults 18-65 all with moderate to severe plaque psoriasis. Week 0 (on no systemic psoriasis medication), Week 16 ( 16 weeks adalimumab), Week 28 ( 16 weeks on adalimumab plus 12 weeks on adalimumab plus 5 mg folic acid, 100 mg B6 and 1000 mcg B12 daily.
161950|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|8 adult 18-65 year old moderate to severe plaque psoriasis patients with levels measured weeks 0,16 and 28 in 4 subjects; weeks 0 and 16 in one subject, weeks 16 and 28 in one subject and week 0 only in 2 subjects.
161951|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adult subjects ages 18-65 with moderate to severe plaque psoriasis measured at week 0 on no systemic psoriasis medication ,week 16 after 16 wqeeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab plus folic acid 5 mg. vitamin B6 100 mg and vitamin B12 1000 mcg daily assessing CBC with diferential for increase, decrease and no change.
161952|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 with moderate to severe plaque psoriasis with subject serum levels to be measured weeks 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab and then 12 weeks of adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of vitamin B12.
161953|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 years with moderate to severe plaque psoriasis measured at week 0 on no systemic psoriasis medication; week 16 on adalimumab for 16 weeks and then week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12.
161954|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adult 18-65 year old adults with moderate to severe plaque psoriasis with adverse event documented sometime during the 28 week study plus telephone call day 70 post week 28 visit either with knowledge of serious event of adverse event documented from data taken weeks 4 and 16 on adalimumab alone and week 28 after 16 weeks on adalimumab plus 12 weeks on adalimumab and daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12 and a telephone call day 70 post week 28 study visit and a telephone call day 70 post week 28 visit.
161955|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 with moderate to severe plaque psoriasis evaluated at after week 16 of study on or after of adalimumab then 12 weeks of adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and vitamin B12 or during the 10 weeks after that.
162173|NCT01704404|O1|Outcome|Dose 1 TD-4208|"22 µg~TD-4208"
161956|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 years with moderate to severe plaque psoriasis evaluated at week 0 on no systemic psoriasis medication; weeks 16 after 16 weeks adalimumab and 28 after 16 weeks adalimumab then 12 weeks adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12.
161957|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 with moderate to severe plaque psoriasis measured at week 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12.
161958|NCT01704599|E1|Reported Event|Humira Then Humira Plus 3 B Vitamins|Pneumonia while on adaimumab and before the adalimumab plus B vitamins were begun.prior to vitamins
161959|NCT01704521|B3|Baseline|Total|Total of all reporting groups
161960|NCT01704521|B2|Baseline|No Lead-in|No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegInterferon + Ribavirin.
161961|NCT01704521|B1|Baseline|Lead-In|Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin.
161962|NCT01704521|P2|Participant Flow|No Lead-in|No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegInterferon + Ribavirin
161963|NCT01704521|P1|Participant Flow|Lead-In|Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin
161964|NCT01704521|O2|Outcome|No Lead-in|No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration PegInterferon + Ribavirin
161965|NCT01704521|O1|Outcome|Lead-In|Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin
161966|NCT01704521|E2|Reported Event|No Lead-in|No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegInterferon + Ribavirin
161967|NCT01704521|E1|Reported Event|Lead-In|Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin
161968|NCT01704495|B5|Baseline|Total|Total of all reporting groups
161969|NCT01704495|B4|Baseline|Placebo|Placebo oral capsules self-administred twice daily
161970|NCT01704495|B3|Baseline|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
161971|NCT01704495|B2|Baseline|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
161972|NCT01704495|B1|Baseline|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
161973|NCT01704495|P4|Participant Flow|Placebo|Placebo oral capsules self-administred twice daily
161974|NCT01704495|P3|Participant Flow|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
161975|NCT01704495|P2|Participant Flow|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
161976|NCT01704495|P1|Participant Flow|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
161977|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
161978|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
161979|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
161980|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
161981|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
161982|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
161983|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
161984|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
161985|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
161986|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
161987|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
161988|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
161989|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
161990|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
161991|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
161992|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
161993|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
161994|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
161995|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
161996|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
161997|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
161998|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
161999|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162000|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162001|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162002|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162003|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162004|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162005|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162040|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162041|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162042|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162043|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162044|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162045|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162046|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162047|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162048|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162049|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162050|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162051|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162052|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162053|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162054|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162055|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162056|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162057|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162058|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162059|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162060|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162061|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162062|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162063|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162064|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162065|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162066|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162067|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162068|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162069|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162070|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162071|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162072|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162073|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162074|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162075|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162076|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162077|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162078|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162079|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162080|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162081|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162082|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162083|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162084|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162085|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162086|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162087|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162088|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162089|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162090|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162091|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162092|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162093|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162094|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162095|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162096|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162097|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162098|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162099|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162100|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162101|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162102|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162103|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162174|NCT01704404|O7|Outcome|Placebo|"Placebo~Placebo"
162104|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162105|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162106|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162107|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162108|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162109|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162110|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162111|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162112|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162113|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162114|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162115|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162116|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162117|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162118|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162119|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162120|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162121|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162122|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162123|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162124|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162125|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162126|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162127|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162128|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162129|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162130|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162131|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162132|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162133|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162134|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162135|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162136|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162137|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162138|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162139|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162140|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162141|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
162142|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162143|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162144|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162145|NCT01704495|E4|Reported Event|Placebo|Placebo oral capsules self-administered twice daily
162146|NCT01704495|E3|Reported Event|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
162147|NCT01704495|E2|Reported Event|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
162148|NCT01704495|E1|Reported Event|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
162149|NCT01704404|B1|Baseline|Entire Study Population|"All subjects received Placebo and 4 of 6 TD-4208 dose levels:~TD-4208 - 22 µg TD-4208 - 44 µg TD-4208 - 88 µg TD-4208 - 175 µg TD-4208 - 350 µg TD-4208 - 700 µg"
162150|NCT01704404|P6|Participant Flow|Treatment 6|Placebo, 44 µg, 88 µg, 175 µg, 350 µg
162151|NCT01704404|P5|Participant Flow|Treatment 5|22 µg, 44 µg, 175 µg, 350 µg
162152|NCT01704404|P4|Participant Flow|Treatment 4|22 µg, 44 µg, 175 µg, 700 µg
162153|NCT01704404|P3|Participant Flow|Treatment 3|Placebo, 22 µg, 88 µg, 175 µg, 700 µg
162154|NCT01704404|P2|Participant Flow|Treatment 2|Placebo, 22 µg, 88 µg, 350 µg, 700 µg
162155|NCT01704404|P1|Participant Flow|Treatment 1|Placebo, 44 µg, 88 µg, 350 µg, 700 µg
162156|NCT01704404|O6|Outcome|Dose 6 TD-4208|"700 µg~TD-4208"
162157|NCT01704404|O5|Outcome|Dose 5 TD-4208|"350 µg~TD-4208"
162158|NCT01704404|O4|Outcome|Dose 4 TD-4208|"175 µg~TD-4208"
162159|NCT01704404|O3|Outcome|Dose 3 TD-4208|"88 µg~TD-4208"
162160|NCT01704404|O2|Outcome|Dose 2 TD-4208|"44 µg~TD-4208"
162161|NCT01704404|O1|Outcome|Dose 1 TD-4208|"22 µg~TD-4208"
162162|NCT01704404|O6|Outcome|Dose 6 TD-4208|"700 µg~TD-4208"
162163|NCT01704404|O5|Outcome|Dose 5 TD-4208|"350 µg~TD-4208"
162164|NCT01704404|O4|Outcome|Dose 4 TD-4208|"175 µg~TD-4208"
162165|NCT01704404|O3|Outcome|Dose 3 TD-4208|"88 µg~TD-4208"
162166|NCT01704404|O2|Outcome|Dose 2 TD-4208|"44 µg~TD-4208"
162167|NCT01704404|O1|Outcome|Dose 1 TD-4208|"22 µg~TD-4208"
162168|NCT01704404|O6|Outcome|Dose 6 TD-4208|"700 µg~TD-4208"
162169|NCT01704404|O5|Outcome|Dose 5 TD-4208|"350 µg~TD-4208"
162170|NCT01704404|O4|Outcome|Dose 4 TD-4208|"175 µg~TD-4208"
162171|NCT01704404|O3|Outcome|Dose 3 TD-4208|"88 µg~TD-4208"
162189|NCT01704287|B3|Baseline|Investigator-Choice Chemotherapy (ICC)|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide).
162190|NCT01704287|B2|Baseline|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
162191|NCT01704287|B1|Baseline|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV Q3W.
162192|NCT01704287|P5|Participant Flow|ICC→Pembrolizumab 10 mg/kg|Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab, must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. Participants received pembrolizumab 10 mg/kg IV Q3W.
162193|NCT01704287|P4|Participant Flow|ICC→Pembrolizumab 2 mg/kg|Participants who were assigned to ICC, experienced confirmed progressive disease (PD) and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab, must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. Participants received pembrolizumab 2 mg/kg IV Q3W.
162194|NCT01704287|P3|Participant Flow|Investigator-Choice Chemotherapy (ICC)|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide).
162195|NCT01704287|P2|Participant Flow|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
162196|NCT01704287|P1|Participant Flow|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg intravenously (IV) every 3 weeks (Q3W).
162197|NCT01704287|O5|Outcome|ICC→Pembrolizumab 10 mg/kg|Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab, must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. Participants received pembrolizumab 10 mg/kg IV Q3W.
162198|NCT01704287|O4|Outcome|ICC→Pembrolizumab 2 mg/kg|Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab, must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. Participants received pembrolizumab 2 mg/kg IV Q3W.
162199|NCT01704287|O3|Outcome|ICC Only|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). This treatment group included the participants who remained on ICC through the database cutoff date.
162200|NCT01704287|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
162201|NCT01704287|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV Q3W.
162202|NCT01704287|O5|Outcome|ICC→Pembrolizumab 10 mg/kg|Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab, must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. Participants received pembrolizumab 10 mg/kg IV Q3W.
162203|NCT01704287|O4|Outcome|ICC→Pembrolizumab 2 mg/kg|Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab, must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. Participants received pembrolizumab 2 mg/kg IV Q3W.
162204|NCT01704287|O3|Outcome|ICC Only|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). This treatment group included the participants who remained on ICC through the database cutoff date.
162205|NCT01704287|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
162206|NCT01704287|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV Q3W.
162207|NCT01704287|O3|Outcome|Investigator-Choice Chemotherapy (ICC)|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide).
162208|NCT01704287|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
162209|NCT01704287|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV Q3W.
162210|NCT01704287|O2|Outcome|ICC→Pembrolizumab 10 mg/kg|Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab, must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. Participants received pembrolizumab 10 mg/kg IV Q3W.
162211|NCT01704287|O1|Outcome|ICC→Pembrolizumab 2 mg/kg|Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab, must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. Participants received pembrolizumab 2 mg/kg IV Q3W.
162212|NCT01704287|O3|Outcome|Investigator-Choice Chemotherapy (ICC)|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide).
162213|NCT01704287|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
162214|NCT01704287|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV Q3W.
162215|NCT01704287|O3|Outcome|Investigator-Choice Chemotherapy (ICC)|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide).
183470|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
162216|NCT01704287|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
162217|NCT01704287|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV Q3W.
162218|NCT01704287|O3|Outcome|Investigator-Choice Chemotherapy (ICC)|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide).
162219|NCT01704287|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
162220|NCT01704287|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV Q3W.
162221|NCT01704287|E7|Reported Event|ICC (After Switch to Pembrolizumab 10 mg/kg)|Participants initially received one of four possible chemotherapy regimens (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide), experienced confirmed PD, met all crossover criteria at study treatment Week 12, and switched to receive pembrolizumab 10 mg/kg. These events occurred while these participants were receiving pembrolizumab 10 mg/kg after switching from ICC.
162222|NCT01704287|E6|Reported Event|ICC (After Switch to Pembrolizumab 2 mg/kg)|Participants initially received one of four possible chemotherapy regimens (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide), experienced confirmed PD, met all crossover criteria at study treatment Week 12, and switched to receive pembrolizumab 2 mg/kg. These events occurred while these participants were receiving pembrolizumab 2 mg/kg after switching from ICC.
162223|NCT01704287|E5|Reported Event|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
162224|NCT01704287|E4|Reported Event|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV Q3W.
162225|NCT01704287|E3|Reported Event|ICC (Before Switch to Pembrolizumab 10 mg/kg)|Participants received one of four possible chemotherapy regimens (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 10 mg/kg. These events occurred while these participants were receiving ICC prior to switching.
162226|NCT01704287|E2|Reported Event|ICC (Before Switch to Pembrolizumab 2 mg/kg)|Participants received one of four possible chemotherapy regimens (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg. These events occurred while these participants were receiving ICC prior to switching.
162227|NCT01704287|E1|Reported Event|ICC Only|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). This treatment group included the participants who remained on ICC through the database cutoff date.
162228|NCT01704261|B3|Baseline|Total|Total of all reporting groups
162229|NCT01704261|B2|Baseline|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
162230|NCT01704261|B1|Baseline|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
162231|NCT01704261|P2|Participant Flow|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
162232|NCT01704261|P1|Participant Flow|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
162233|NCT01704261|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
162234|NCT01704261|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
162235|NCT01704261|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
162236|NCT01704261|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
162237|NCT01704261|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
162238|NCT01704261|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
162239|NCT01704261|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
162322|NCT01703858|O5|Outcome|E : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.
162240|NCT01704261|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
162241|NCT01704261|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
162242|NCT01704261|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
162243|NCT01704261|E2|Reported Event|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
162244|NCT01704261|E1|Reported Event|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
162245|NCT01704196|B3|Baseline|Total|Total of all reporting groups
162246|NCT01704196|B2|Baseline|Placebo|"Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.~Placebo"
162247|NCT01704196|B1|Baseline|Nepicastat|"Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks~Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks."
162248|NCT01704196|P2|Participant Flow|Placebo|"Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.~Placebo"
162249|NCT01704196|P1|Participant Flow|Nepicastat|"Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks~Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks."
162250|NCT01704196|O2|Outcome|Placebo|"Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.~Placebo"
162251|NCT01704196|O1|Outcome|Nepicastat|"Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks~Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks."
162252|NCT01704196|O2|Outcome|Placebo|"Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.~Placebo"
162253|NCT01704196|O1|Outcome|Nepicastat|"Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks~Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks."
162254|NCT01704196|E2|Reported Event|Placebo|"Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.~Placebo"
162255|NCT01704196|E1|Reported Event|Nepicastat|"Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks~Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks."
162256|NCT01704079|B3|Baseline|Total|Total of all reporting groups
162257|NCT01704079|B2|Baseline|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
162258|NCT01704079|B1|Baseline|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
162259|NCT01704079|P2|Participant Flow|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
162260|NCT01704079|P1|Participant Flow|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
162261|NCT01704079|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
162262|NCT01704079|O1|Outcome|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
162263|NCT01704079|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
162325|NCT01703858|O2|Outcome|B : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.
162264|NCT01704079|O1|Outcome|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
162265|NCT01704079|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
162266|NCT01704079|O1|Outcome|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
162267|NCT01704079|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
162268|NCT01704079|O1|Outcome|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
162269|NCT01704079|E2|Reported Event|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
162270|NCT01704079|E1|Reported Event|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
162271|NCT01703988|B5|Baseline|Total|Total of all reporting groups
162272|NCT01703988|B4|Baseline|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
162273|NCT01703988|B3|Baseline|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
162274|NCT01703988|B2|Baseline|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
162275|NCT01703988|B1|Baseline|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, IT injection
162276|NCT01703988|P4|Participant Flow|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
162277|NCT01703988|P3|Participant Flow|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
162278|NCT01703988|P2|Participant Flow|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
162279|NCT01703988|P1|Participant Flow|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, intrathecal (IT) injection
162280|NCT01703988|O1|Outcome|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
162281|NCT01703988|O4|Outcome|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
162282|NCT01703988|O3|Outcome|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
162283|NCT01703988|O2|Outcome|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
162284|NCT01703988|O1|Outcome|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, IT injection
162285|NCT01703988|O4|Outcome|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
162286|NCT01703988|O3|Outcome|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
162287|NCT01703988|O2|Outcome|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
162288|NCT01703988|O1|Outcome|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, IT injection
162289|NCT01703988|O4|Outcome|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
162290|NCT01703988|O3|Outcome|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
162291|NCT01703988|O2|Outcome|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
162292|NCT01703988|O1|Outcome|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, IT injection
162293|NCT01703988|O4|Outcome|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
162294|NCT01703988|O3|Outcome|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
162295|NCT01703988|O2|Outcome|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
162296|NCT01703988|O1|Outcome|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, IT injection
162297|NCT01703988|O4|Outcome|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
162298|NCT01703988|O3|Outcome|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
162299|NCT01703988|O2|Outcome|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
162300|NCT01703988|O1|Outcome|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, IT injection
162301|NCT01703988|E4|Reported Event|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
162302|NCT01703988|E3|Reported Event|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
162303|NCT01703988|E2|Reported Event|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
162304|NCT01703988|E1|Reported Event|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, IT injection
162305|NCT01703858|B4|Baseline|Total|Total of all reporting groups
162323|NCT01703858|O4|Outcome|D : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
162555|NCT01703221|O3|Outcome|Placebo (Phase A)|Placebo for 24 weeks (Phase A)
162306|NCT01703858|B3|Baseline|C - B - A - D - E|Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) and then the oral solution of BI-113608 (50 mg) under fasted conditions (A) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
162307|NCT01703858|B2|Baseline|B - A - C - D - E|Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B), then they received oral solution of BI-113608 (50 mg) under fasted conditions (A) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
162308|NCT01703858|B1|Baseline|A - C - B - D - E|Participants first received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions (A), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
162309|NCT01703858|P3|Participant Flow|C - B - A - D - E|Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) and then the oral solution of BI-113608 (50 mg) under fasted conditions (A) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
162310|NCT01703858|P2|Participant Flow|B - A - C - D - E|Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B), then they received oral solution of BI-113608 (50 mg) under fasted conditions (A) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
162311|NCT01703858|P1|Participant Flow|A - C - B - D - E|Participants first received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions (A), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
162312|NCT01703858|O5|Outcome|E : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.
162313|NCT01703858|O4|Outcome|D : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
162314|NCT01703858|O3|Outcome|C : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.
162315|NCT01703858|O2|Outcome|B : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.
162316|NCT01703858|O1|Outcome|A : BI-113608|Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.
162317|NCT01703858|O5|Outcome|E : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.
162318|NCT01703858|O4|Outcome|D : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
162319|NCT01703858|O3|Outcome|C : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.
162320|NCT01703858|O2|Outcome|B : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.
162321|NCT01703858|O1|Outcome|A : BI-113608|Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.
162324|NCT01703858|O3|Outcome|C : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.
162326|NCT01703858|O1|Outcome|A : BI-113608|Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.
162327|NCT01703858|E6|Reported Event|E : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.
162328|NCT01703858|E5|Reported Event|D : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
162329|NCT01703858|E4|Reported Event|Pantoprazole 40mg|Participants received single dose of Pantoprazole 40mg alone twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
162330|NCT01703858|E3|Reported Event|C : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.
162331|NCT01703858|E2|Reported Event|B : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.
162332|NCT01703858|E1|Reported Event|A : BI-113608|Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.
162333|NCT01703845|B3|Baseline|Total|Total of all reporting groups
162334|NCT01703845|B2|Baseline|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162335|NCT01703845|B1|Baseline|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162336|NCT01703845|P2|Participant Flow|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162337|NCT01703845|P1|Participant Flow|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162338|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC).The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162339|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC).The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162340|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC).The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162341|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162342|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162343|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162344|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162345|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162346|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC).The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162347|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162348|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162349|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162350|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162351|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162352|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162353|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC).The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162354|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC).The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162355|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162356|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162357|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162358|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162359|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162360|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162361|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162362|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162363|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162364|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162365|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162366|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162367|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162368|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162369|NCT01703845|E2|Reported Event|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162370|NCT01703845|E1|Reported Event|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
162371|NCT01703832|B3|Baseline|Total|Total of all reporting groups
162372|NCT01703832|B2|Baseline|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
162373|NCT01703832|B1|Baseline|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
162374|NCT01703832|P2|Participant Flow|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
162375|NCT01703832|P1|Participant Flow|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
162376|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
162377|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
162378|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
162554|NCT01703221|O1|Outcome|Omarigliptin (Phase A+B)|Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
162379|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
162380|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
162381|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
162382|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
162383|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
162384|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
162385|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
162386|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
162387|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
162388|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
162389|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
162390|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
162391|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
162392|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
162393|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
162394|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
162395|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
162396|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
162397|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
162398|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
162399|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
162400|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
162401|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
162402|NCT01703832|E2|Reported Event|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
162403|NCT01703832|E1|Reported Event|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
162404|NCT01703819|B3|Baseline|Total|Total of all reporting groups
162405|NCT01703819|B2|Baseline|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
162406|NCT01703819|B1|Baseline|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to~-30 minutes~Neurexan®"
162407|NCT01703819|P2|Participant Flow|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
162408|NCT01703819|P1|Participant Flow|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
162409|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
162410|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
162411|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
162412|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
162413|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
162414|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
162415|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
162416|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
162417|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
162418|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
162419|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
162420|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
162421|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
162422|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
162423|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
162424|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
162425|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
162426|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
162427|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
162428|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
162429|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
162430|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
162431|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
162432|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
162433|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
162434|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
162435|NCT01703819|E2|Reported Event|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
162436|NCT01703819|E1|Reported Event|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
162437|NCT01703741|B1|Baseline|Testosterone Gel (FE 999303)|Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.
162438|NCT01703741|P1|Participant Flow|Testosterone Gel (FE 999303)|Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.
162439|NCT01703741|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.
162440|NCT01703741|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.
162441|NCT01703741|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.
162442|NCT01703741|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.
162443|NCT01703741|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.
162444|NCT01703741|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.
162445|NCT01703741|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.
162446|NCT01703741|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.
162447|NCT01703741|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.
162448|NCT01703741|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.
162449|NCT01703741|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.
162450|NCT01703741|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.
162451|NCT01703741|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.
162452|NCT01703741|E1|Reported Event|Testosterone Gel (FE 999303)|Subjects received testosterone gel with initial dose as fixed on Day 56 during the 000023 study. The dose was further down titrated based on serum testosterone levels. Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
162453|NCT01703702|B3|Baseline|Total|Total of all reporting groups
162454|NCT01703702|B2|Baseline|Control|"Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months~florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration"
162455|NCT01703702|B1|Baseline|Intervention|"Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.~florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration"
162456|NCT01703702|P2|Participant Flow|Control|"Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months~florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration"
162457|NCT01703702|P1|Participant Flow|Intervention|"Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.~florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration"
162458|NCT01703702|O2|Outcome|Control|Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
162459|NCT01703702|O1|Outcome|Intervention|Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
162460|NCT01703702|O2|Outcome|Control|Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
162461|NCT01703702|O1|Outcome|Intervention|Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
162462|NCT01703702|O2|Outcome|Control|Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
162463|NCT01703702|O1|Outcome|Intervention|Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
162464|NCT01703702|O2|Outcome|Control Scan/Diagnosis Concordant|Control arm patients whose florbetapir F18 PET scan results were predicted by their initial diagnosis
162465|NCT01703702|O1|Outcome|Intervention Scan/Diagnosis Concordant|Intervention arm patients whose florbetapir F18 PET scan results were predicted by their initial diagnosis
162466|NCT01703702|O2|Outcome|Control Scan/Diagnosis Discordant|Intervention arm patients whose florbetapir F18 PET scan results were not predicted by their initial diagnosis
183471|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
162467|NCT01703702|O1|Outcome|Intervention Scan/Diagnosis Discordant|Intervention arm patients whose florbetapir F18 PET scan results were not predicted by their baseline clinical diagnosis.
162468|NCT01703702|O2|Outcome|Mild Impairment AB-|Patients diagnosed with a cognitive status of mild impairment and AB- scan result.
162469|NCT01703702|O1|Outcome|Mild Impairment AB+|Patients diagnosed with a cognitive status of mild impairment and AB+ scan result.
162470|NCT01703702|O2|Outcome|Control|Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
162471|NCT01703702|O1|Outcome|Intervention|Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
162472|NCT01703702|E1|Reported Event|Safety Population|620 patients received florbetapir (18F) and comprise the Safety Population.
162473|NCT01703663|B1|Baseline|All Participants|
162474|NCT01703663|P2|Participant Flow|Control Night First Night, EPAP Therapy Second Night|During the first night, the subject was assigned to no EPAP (control night). During the second night, the subject was assigned to wear EPAP. During both nights, sleep disordered breathing was monitored with the WatchPAT device.
162475|NCT01703663|P1|Participant Flow|EPAP Therapy First Night, Then Control Night|During the first night, the subject was assigned to wear EPAP. During the second night, the subject did not wear EPAP (control night). During both nights, sleep disordered breathing was monitored with the WatchPAT device.
162476|NCT01703663|O2|Outcome|Control Night|Raw data from control night (not taking into account period effect).
162477|NCT01703663|O1|Outcome|EPAP Night|Raw data from EPAP night (not taking into account period effect).
162478|NCT01703663|E2|Reported Event|Control Night|
162479|NCT01703663|E1|Reported Event|EPAP Night|
162480|NCT01703286|B1|Baseline|Total Participants|All study participants
162481|NCT01703286|P6|Participant Flow|L 5/ Pbo/ G1-4/|Linagliptin 1 tablet (5 mg) once daily for 28 days/ Placebo tablet once daily over 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
162482|NCT01703286|P5|Participant Flow|Pbo/ L 5/ G1-4|Placebo tablet once daily over 28 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
162483|NCT01703286|P4|Participant Flow|G1-4/ Pbo/ L 5|Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Placebo tablet once daily over 28 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days
162484|NCT01703286|P3|Participant Flow|G 1-4/ L 5/ Pbo|Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days/ Placebo tablet once daily over 28 days
162485|NCT01703286|P2|Participant Flow|L 5/ G 1-4/ Pbo|Linagliptin 1 tablet (5 mg) once daily for 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Placebo tablet once daily over 28 days
162486|NCT01703286|P1|Participant Flow|Pbo/ G1-4/ L 5|Placebo tablet once daily over 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days
162487|NCT01703286|O6|Outcome|Rep - Placebo|Residual effect period - Placebo
162488|NCT01703286|O5|Outcome|REP - Glimepiride 1-4 mg|Residual effect period - Glimepiride 1-4 mg
162489|NCT01703286|O4|Outcome|REP - Linagliptin 5 mg|Residual effect period - Linagliptin 5 mg
162490|NCT01703286|O3|Outcome|Placebo|Placebo: matching Linagliptin or Glimepiride tablet once daily over 28 days
162491|NCT01703286|O2|Outcome|Glimepiride 1-4 mg|Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
162492|NCT01703286|O1|Outcome|Linagliptin 5 mg|Linagliptin: 1 tablet (5 mg) once daily for 28 days
162493|NCT01703286|O3|Outcome|Placebo|Placebo: matching Linagliptin or Glimepiride tablet once daily over 28 days
162494|NCT01703286|O2|Outcome|Glimepiride 1-4 mg|Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
162495|NCT01703286|O1|Outcome|Linagliptin 5 mg|Linagliptin: 1 tablet (5 mg) once daily for 28 days
162496|NCT01703286|O3|Outcome|Placebo|Placebo: matching Linagliptin or Glimepiride tablet once daily over 28 days
162497|NCT01703286|O2|Outcome|Glimepiride 1-4 mg|Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
162498|NCT01703286|O1|Outcome|Linagliptin 5 mg|Linagliptin: 1 tablet (5 mg) once daily for 28 days
162499|NCT01703286|O3|Outcome|Placebo|Placebo: matching Linagliptin or Glimepiride tablet once daily over 28 days
162500|NCT01703286|O2|Outcome|Glimepiride 1-4 mg|Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
162501|NCT01703286|O1|Outcome|Linagliptin 5 mg|Linagliptin: 1 tablet (5 mg) once daily for 28 days
162502|NCT01703286|E3|Reported Event|Placebo|Placebo: matching Linagliptin or Glimepiride given once daily over 28 days
162503|NCT01703286|E2|Reported Event|Glimepiride 1-4 mg|Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
162504|NCT01703286|E1|Reported Event|Linagliptin 5 mg|Linagliptin: 1 tablet (5 mg) once daily for 28 days
162505|NCT01703260|B4|Baseline|Total|Total of all reporting groups
162506|NCT01703260|B3|Baseline|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
162507|NCT01703260|B2|Baseline|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
162508|NCT01703260|B1|Baseline|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
162509|NCT01703260|P3|Participant Flow|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
162510|NCT01703260|P2|Participant Flow|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
183472|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
162511|NCT01703260|P1|Participant Flow|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
162512|NCT01703260|O3|Outcome|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
162513|NCT01703260|O2|Outcome|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
162514|NCT01703260|O1|Outcome|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
162515|NCT01703260|O3|Outcome|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
162516|NCT01703260|O2|Outcome|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
162517|NCT01703260|O1|Outcome|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
162518|NCT01703260|O3|Outcome|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
162519|NCT01703260|O2|Outcome|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
162520|NCT01703260|O1|Outcome|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
162521|NCT01703260|O3|Outcome|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
162522|NCT01703260|O2|Outcome|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
162523|NCT01703260|O1|Outcome|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
162524|NCT01703260|O3|Outcome|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
162525|NCT01703260|O2|Outcome|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
162526|NCT01703260|O1|Outcome|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
162527|NCT01703260|O3|Outcome|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
162528|NCT01703260|O2|Outcome|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
162529|NCT01703260|O1|Outcome|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
162530|NCT01703260|E3|Reported Event|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
162531|NCT01703260|E2|Reported Event|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
162532|NCT01703260|E1|Reported Event|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
162533|NCT01703221|B4|Baseline|Total|Total of all reporting groups
162534|NCT01703221|B3|Baseline|Placebo (Phase A) Switching to Omarigliptin (Phase B)|Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
162535|NCT01703221|B2|Baseline|Sitagliptin (Phase A) Switching to Omarigliptin (Phase B)|Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
162536|NCT01703221|B1|Baseline|Omarigliptin (Phase A+B)|Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
162537|NCT01703221|P3|Participant Flow|Placebo (Phase A) Switching to Omarigliptin (Phase B)|Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
162538|NCT01703221|P2|Participant Flow|Sitagliptin (Phase A) Switching to Omarigliptin (Phase B)|Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
162539|NCT01703221|P1|Participant Flow|Omarigliptin (Phase A+B)|Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
162540|NCT01703221|O3|Outcome|Placebo (Phase A)|Placebo for 24 weeks (Phase A)
162541|NCT01703221|O2|Outcome|Sitagliptin (Phase A)|Sitagliptin 50 mg once daily for 24 weeks (Phase A)
162542|NCT01703221|O1|Outcome|Omarigliptin (Phase A)|Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
162543|NCT01703221|O3|Outcome|Placebo (Phase A)|Placebo for 24 weeks (Phase A)
162544|NCT01703221|O2|Outcome|Sitagliptin (Phase A)|Sitagliptin 50 mg once daily for 24 weeks (Phase A)
162545|NCT01703221|O1|Outcome|Omarigliptin (Phase A)|Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
162546|NCT01703221|O3|Outcome|Omarigliptin (Phase B)-P|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from placebo
162547|NCT01703221|O2|Outcome|Omarigliptin (Phase B)-S|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from sitagliptin
162548|NCT01703221|O1|Outcome|Omarigliptin (Phase A+B)|Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
162549|NCT01703221|O3|Outcome|Placebo (Phase A)|Placebo for 24 weeks (Phase A)
162550|NCT01703221|O2|Outcome|Sitagliptin (Phase A)|Sitagliptin 50 mg once daily for 24 weeks (Phase A)
162551|NCT01703221|O1|Outcome|Omarigliptin (Phase A)|Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
162552|NCT01703221|O3|Outcome|Omarigliptin (Phase B)-P|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from placebo
162553|NCT01703221|O2|Outcome|Omarigliptin (Phase B)-S|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from sitagliptin
162556|NCT01703221|O2|Outcome|Sitagliptin (Phase A)|Sitagliptin 50 mg once daily for 24 weeks (Phase A)
162557|NCT01703221|O1|Outcome|Omarigliptin (Phase A)|Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
162558|NCT01703221|O3|Outcome|Placebo (Phase A)|Placebo for 24 weeks (Phase A)
162559|NCT01703221|O2|Outcome|Sitagliptin (Phase A)|Sitagliptin 50 mg once daily for 24 weeks (Phase A)
162560|NCT01703221|O1|Outcome|Omarigliptin (Phase A)|Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
162561|NCT01703221|E6|Reported Event|Omarigliptin (Phase B)-P|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from placebo
162562|NCT01703221|E5|Reported Event|Omarigliptin (Phase B)-S|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from sitagliptin
162563|NCT01703221|E4|Reported Event|Omarigliptin (Phase A + B)|Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
162564|NCT01703221|E3|Reported Event|Placebo (Phase A)|Placebo for 24 weeks (Phase A)
162565|NCT01703221|E2|Reported Event|Sitagliptin (Phase A)|Sitagliptin 50 mg once daily for 24 weeks (Phase A)
162566|NCT01703221|E1|Reported Event|Omarigliptin (Phase A)|Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
162567|NCT01703208|B3|Baseline|Total|Total of all reporting groups
162568|NCT01703208|B2|Baseline|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162569|NCT01703208|B1|Baseline|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162570|NCT01703208|P2|Participant Flow|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162571|NCT01703208|P1|Participant Flow|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162572|NCT01703208|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162573|NCT01703208|O1|Outcome|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162574|NCT01703208|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162575|NCT01703208|O1|Outcome|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162576|NCT01703208|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162577|NCT01703208|O1|Outcome|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162578|NCT01703208|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162579|NCT01703208|O1|Outcome|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162580|NCT01703208|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162581|NCT01703208|O1|Outcome|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162582|NCT01703208|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162583|NCT01703208|O1|Outcome|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162584|NCT01703208|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162585|NCT01703208|O1|Outcome|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162586|NCT01703208|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162587|NCT01703208|O1|Outcome|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162588|NCT01703208|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162589|NCT01703208|O1|Outcome|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162590|NCT01703208|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162591|NCT01703208|O1|Outcome|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162592|NCT01703208|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162593|NCT01703208|O1|Outcome|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162594|NCT01703208|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162595|NCT01703208|O1|Outcome|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162596|NCT01703208|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162597|NCT01703208|O1|Outcome|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162598|NCT01703208|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162599|NCT01703208|O1|Outcome|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162600|NCT01703208|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162601|NCT01703208|O1|Outcome|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162602|NCT01703208|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162603|NCT01703208|O1|Outcome|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162604|NCT01703208|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162605|NCT01703208|O1|Outcome|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162606|NCT01703208|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162607|NCT01703208|O1|Outcome|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162608|NCT01703208|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162609|NCT01703208|O1|Outcome|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162610|NCT01703208|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162611|NCT01703208|O1|Outcome|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162612|NCT01703208|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162613|NCT01703208|O1|Outcome|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162614|NCT01703208|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162615|NCT01703208|O1|Outcome|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162616|NCT01703208|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162617|NCT01703208|O1|Outcome|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162618|NCT01703208|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162619|NCT01703208|O1|Outcome|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162620|NCT01703208|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162621|NCT01703208|O1|Outcome|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162622|NCT01703208|E2|Reported Event|Placebo|Matching placebo to omarigliptin capsule or tablet administered once weekly.
162623|NCT01703208|E1|Reported Event|Omarigliptin 25 mg|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
162624|NCT01703169|B1|Baseline|Eltrombopag|"Single arm study. Dose Escalation.~Eltrombopag: Oral eltrombopag 150mg/day by mouth starting on Day 1 with dose modification over 12 weeks to a maximum of 300mg/day determined by platelet count"
162625|NCT01703169|P1|Participant Flow|Eltrombopag|"Single arm study. Dose Escalation.~Eltrombopag: Oral eltrombopag 150mg/day by mouth starting on Day 1 with dose modification over 12 weeks to a maximum of 300mg/day determined by platelet count"
162626|NCT01703169|O1|Outcome|Eltrombopag|"Single arm study. Dose Escalation.~Eltrombopag: Oral eltrombopag 150mg/day by mouth starting on Day 1 with dose modification over 12 weeks to a maximum of 300mg/day determined by platelet count"
162627|NCT01703169|O1|Outcome|Eltrombopag|"Single arm study. Dose Escalation.~Eltrombopag: Oral eltrombopag 150mg/day by mouth starting on Day 1 with dose modification over 12 weeks to a maximum of 300mg/day determined by platelet count"
162628|NCT01703169|O1|Outcome|Eltrombopag|"Single arm study. Dose Escalation.~Eltrombopag: Oral eltrombopag 150mg/day by mouth starting on Day 1 with dose modification over 12 weeks to a maximum of 300mg/day determined by platelet count"
162629|NCT01703169|O1|Outcome|Eltrombopag|"Single arm study. Dose Escalation.~Eltrombopag: Oral eltrombopag 150mg/day by mouth starting on Day 1 with dose modification over 12 weeks to a maximum of 300mg/day determined by platelet count"
162630|NCT01703169|O1|Outcome|Eltrombopag|"Single arm study. Dose Escalation.~Eltrombopag: Oral eltrombopag 150mg/day by mouth starting on Day 1 with dose modification over 12 weeks to a maximum of 300mg/day determined by platelet count"
162631|NCT01703169|E1|Reported Event|Eltrombopag|"Single arm study. Dose Escalation.~Eltrombopag: Oral eltrombopag 150mg/day by mouth starting on Day 1 with dose modification over 12 weeks to a maximum of 300mg/day determined by platelet count"
162632|NCT01703091|B3|Baseline|Total|Total of all reporting groups
162633|NCT01703091|B2|Baseline|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
162634|NCT01703091|B1|Baseline|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
162635|NCT01703091|P2|Participant Flow|Placebo Plus Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
162636|NCT01703091|P1|Participant Flow|Ramucirumab Plus Docetaxel|Ramucirumab 10 milligrams/kilogram (mg/kg) administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 milligrams/square meter (mg/m2) administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
162637|NCT01703091|O2|Outcome|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
162638|NCT01703091|O1|Outcome|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
162639|NCT01703091|O2|Outcome|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
162640|NCT01703091|O1|Outcome|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
162641|NCT01703091|O2|Outcome|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
162642|NCT01703091|O1|Outcome|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
162643|NCT01703091|O2|Outcome|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
162644|NCT01703091|O1|Outcome|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
162645|NCT01703091|O2|Outcome|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
162646|NCT01703091|O1|Outcome|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
162647|NCT01703091|O2|Outcome|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
162648|NCT01703091|O1|Outcome|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
162649|NCT01703091|E2|Reported Event|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
162650|NCT01703091|E1|Reported Event|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
162651|NCT01703000|B1|Baseline|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162652|NCT01703000|P1|Participant Flow|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162653|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162654|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162655|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162656|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162657|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162658|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162659|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162660|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162661|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162662|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162663|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162664|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162665|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162666|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162667|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162668|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162669|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162670|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162671|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162672|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162673|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162674|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162703|NCT01702896|B1|Baseline|Number of Participants|Treated with Interleukin-2
162675|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162676|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162677|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162678|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162679|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162680|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162681|NCT01703000|E1|Reported Event|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
162682|NCT01702987|B3|Baseline|Total|Total of all reporting groups
162683|NCT01702987|B2|Baseline|Statin + Ubiquinol|"12 patients on statins and ubiquinol~ubiquinol: ubiquinol supplementation was given for 1 month to 12 patients~statin: statin was given for 1 month to 21 patients"
162684|NCT01702987|B1|Baseline|Statin + Placebo|"9 patients taking statin medications and placebo.~placebo: placebo (identical in appearance to ubiquinol) was given for 1 month to 9 patients~statin: statin was given for 1 month to 21 patients"
162685|NCT01702987|P2|Participant Flow|Statin + Ubiquinol|"12 patients on statins and ubiquinol~ubiquinol: ubiquinol supplementation was given for 1 month to 12 patients~statin: statin was given for 1 month to 21 patients"
162686|NCT01702987|P1|Participant Flow|Statin + Placebo|"9 patients taking statin medications and placebo.~placebo: placebo (identical in appearance to ubiquinol) was given for 1 month to 9 patients~statin: statin was given for 1 month to 21 patients"
162687|NCT01702987|O2|Outcome|Statin + Ubiquinol|"12 patients on statins and ubiquinol~ubiquinol: ubiquinol supplementation was given for 1 month to 12 patients~statin: statin was given for 1 month to 21 patients"
162688|NCT01702987|O1|Outcome|Statin + Placebo|"9 patients taking statin medications and placebo.~placebo: placebo (identical in appearance to ubiquinol) was given for 1 month to 9 patients~statin: statin was given for 1 month to 21 patients"
162689|NCT01702987|E2|Reported Event|Statin + Placebo|"9 patients taking statin medications and placebo.~placebo: placebo (identical in appearance to ubiquinol) was given for 1 month to 9 patients~statin: statin was given for 1 month to 21 patients"
162690|NCT01702987|E1|Reported Event|Statin + Ubiquinol|"12 patients on statins and ubiquinol~ubiquinol: ubiquinol supplementation was given for 1 month to 12 patients~statin: statin was given for 1 month to 21 patients"
162691|NCT01702961|B1|Baseline|Rituxan+BEAM: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells~BEAM Conditioning.~Melphalan: Given on Day -1~Melphalan is administered according to the current SOP.~Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2~VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2~BCNU: BCNU 300 mg/m2 IV given on Day -6~Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28~Stem Cells: Stem cells given on Day 0"
162692|NCT01702961|P1|Participant Flow|Rituxan+BEAM: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.~Melphalan: Given on Day -1~Melphalan is administered according to the current SOP.~Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2~VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2~BCNU: BCNU 300 mg/m2 IV given on Day -6~Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28~Stem Cells: Stem cells given on Day 0"
162693|NCT01702961|O1|Outcome|BEAM + R: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.~Melphalan: Given on Day -1~Melphalan is administered according to the current SOP.~Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2~VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2~BCNU: BCNU 300 mg/m2 IV given on Day -6~Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28~Stem Cells: Stem cells given on Day 0"
162694|NCT01702961|O1|Outcome|BEAM + R: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.~Melphalan: Given on Day -1~Melphalan is administered according to the current SOP.~Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2~VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2~BCNU: BCNU 300 mg/m2 IV given on Day -6~Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28~Stem Cells: Stem cells given on Day 0"
162695|NCT01702961|O1|Outcome|BEAM + R: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.~Melphalan: Given on Day -1~Melphalan is administered according to the current SOP.~Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2~VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2~BCNU: BCNU 300 mg/m2 IV given on Day -6~Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28~Stem Cells: Stem cells given on Day 0"
162696|NCT01702961|E1|Reported Event|Rituxan+BEAM: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.~BEAM Conditioning.~Melphalan: Given on Day -1~Melphalan is administered according to the current SOP.~Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2~VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2~BCNU: BCNU 300 mg/m2 IV given on Day -6~Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28~Stem Cells: Stem cells given on Day 0"
162697|NCT01702909|B1|Baseline|Number of Participants|Treated with Interleukin-2
162698|NCT01702909|P1|Participant Flow|Interleukin-2|Interleukin 2 (IL-2) is naturally produced by the body to help fight infection and prevent autoimmune diseases. In cancer treatment, IL-2 is designed to target adaptive immune cells, such as T-cells and B-cells, to respond to tumors. IL-2 may help the body produce antigen-fighting T-cells and stimulate B-cells to produce more antibodies.
162699|NCT01702909|O1|Outcome|Response Rate|Percentage of Patients Responding to Interleukin-2
162700|NCT01702909|O1|Outcome|Response Rate|Percentage of Patients Responding to Interleukin-2
162701|NCT01702909|O1|Outcome|Response Rate|Percentage of Patients Responding to Interleukin-2
162702|NCT01702909|E1|Reported Event|Adverse Events|Patients receiving Interleukin-2
162704|NCT01702896|P1|Participant Flow|Interleukin-2|All patients received Interleukin-2
162705|NCT01702896|O1|Outcome|Median Survival|Median survival was measured from date of entry on study until date of death
162706|NCT01702896|O1|Outcome|Interleukin-2|"Interleukin-2~Interleukin-2: Interleukin-2"
162707|NCT01702896|O1|Outcome|Response Rate|Percentage of patient who received IL-2 that had a positive response to treatment.
162708|NCT01702896|E1|Reported Event|Adverse Events|Patients receiving Interleukin-2
162709|NCT01702532|B3|Baseline|Total|Total of all reporting groups
162710|NCT01702532|B2|Baseline|Nicotine Lozenge 2 mg|Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 – 30 minutes).
162711|NCT01702532|B1|Baseline|Nicotine Mouth Film 2.5 mg|Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
162712|NCT01702532|P2|Participant Flow|Nicotine Lozenge 2 mg|Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 to 30 minutes).
162713|NCT01702532|P1|Participant Flow|Nicotine Mouth Film 2.5 mg|Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
162714|NCT01702532|O2|Outcome|Nicotine Lozenge 2 mg|Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 – 30 minutes).
162715|NCT01702532|O1|Outcome|Nicotine Mouth Film 2.5 mg|Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
162716|NCT01702532|O2|Outcome|Nicotine Lozenge 2 mg|Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 – 30 minutes)
162717|NCT01702532|O1|Outcome|Nicotine Mouth Film 2.5 mg|Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
162718|NCT01702532|E2|Reported Event|Nicotine Lozenge 2 mg|Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 to 30 minutes).
162719|NCT01702532|E1|Reported Event|Nicotine Mouth Film 2.5 mg|Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
162720|NCT01702519|B3|Baseline|Total|Total of all reporting groups
162721|NCT01702519|B2|Baseline|Reference Then Test Patch|Participants first applied the Reference nicotine patch (21 mg) containing test adhesive for 24 hours, and then entered a washout period of 48 hours. Post-washout, they applied the Test nicotine patch containing reference adhesive (21 mg) for additional 24 hours.
162722|NCT01702519|B1|Baseline|Test Then Reference Patch|Participants first applied a test nicotine patch (21 mg) containing test adhesive for 24 hours, and then entered a washout period of 48 hours. Post-washout, they applied reference nicotine patch containing Reference adhesive (21 mg) for additional 24 hours.
162723|NCT01702519|P2|Participant Flow|Reference Then Test Patch|Participants first applied the Reference nicotine patch (21 mg) containing test adhesive for 24 hours, and then entered a washout period of 48 hours. Post-washout, they applied the Test nicotine patch containing reference adhesive (21 mg) for additional 24 hours.
162724|NCT01702519|P1|Participant Flow|Test Then Reference Patch|Participants first applied a test nicotine patch (21 mg) containing test adhesive for 24 hours, and then entered a washout period of 48 hours. Post-washout, they applied reference nicotine patch containing Reference adhesive (21 mg) for additional 24 hours.
162725|NCT01702519|O2|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch with reference adhesive, for 24 hours.
162726|NCT01702519|O1|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch with test adhesive, for 24 hours.
162727|NCT01702519|O2|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch with reference adhesive, for 24 hours.
162728|NCT01702519|O1|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch with test adhesive, for 24 hours.
162729|NCT01702519|O2|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch with reference adhesive, for 24 hours.
162730|NCT01702519|O1|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch with test adhesive, for 24 hours.
162731|NCT01702519|O2|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with reference adhesive, for 24 hours
162732|NCT01702519|O1|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with test adhesive, for 24 hours
162733|NCT01702519|O2|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with the reference adhesive, for 24 hours.
162734|NCT01702519|O1|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with test adhesive, for 24 hours.
162735|NCT01702519|O2|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with the reference adhesive, for 24 hours.
162736|NCT01702519|O1|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with test adhesive, for 24 hours.
162737|NCT01702519|E2|Reported Event|Reference Patch|Participants were instructed to wear transdermal nicotine patch with reference adhesive, for 24 hours
162738|NCT01702519|E1|Reported Event|Test Patch|Participants were instructed to wear transdermal nicotine patch with test adhesive, for 24 hours.
162739|NCT01702454|B3|Baseline|Total|Total of all reporting groups
162740|NCT01702454|B2|Baseline|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162741|NCT01702454|B1|Baseline|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162742|NCT01702454|P2|Participant Flow|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162743|NCT01702454|P1|Participant Flow|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162744|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|SuSubjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162745|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162746|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162747|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162748|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162749|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162750|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162751|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162752|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162753|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162754|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162755|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162756|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162757|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162758|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162759|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162760|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162761|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162762|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162763|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm
162764|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162765|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162766|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162767|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162768|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162769|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162770|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162771|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162772|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162773|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162774|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162775|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm
162776|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162777|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162778|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162779|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm
162780|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162781|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162782|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162783|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162784|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162785|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162786|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162787|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162788|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162789|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162790|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162791|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162792|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162793|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162794|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162795|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162796|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162797|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162798|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162799|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162800|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162801|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162802|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162803|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162804|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162805|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162806|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162807|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NC T01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162808|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162809|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162810|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162811|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162812|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162813|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162814|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162815|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162816|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162817|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162818|NCT01702454|E2|Reported Event|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162819|NCT01702454|E1|Reported Event|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
162820|NCT01702363|B1|Baseline|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
162821|NCT01702363|P1|Participant Flow|UMEC 125 µg QD|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
162822|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
162823|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
162824|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
162825|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
162826|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
162827|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
162828|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
162829|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
162830|NCT01702363|O1|Outcome|MEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
162831|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
162832|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
162833|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
162834|NCT01702363|E1|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
162835|NCT01702311|B3|Baseline|Total|Total of all reporting groups
162836|NCT01702311|B2|Baseline|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
162837|NCT01702311|B1|Baseline|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
162892|NCT01702259|O2|Outcome|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
183473|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
162838|NCT01702311|P2|Participant Flow|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
162839|NCT01702311|P1|Participant Flow|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
162840|NCT01702311|O2|Outcome|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
162841|NCT01702311|O1|Outcome|no Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (at bedtime) and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
162842|NCT01702311|O2|Outcome|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
162843|NCT01702311|O1|Outcome|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
162844|NCT01702311|O2|Outcome|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
162845|NCT01702311|O1|Outcome|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
162846|NCT01702311|O2|Outcome|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
162847|NCT01702311|O1|Outcome|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
162848|NCT01702311|O2|Outcome|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
162849|NCT01702311|O1|Outcome|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
162850|NCT01702311|O2|Outcome|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
162851|NCT01702311|O1|Outcome|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
162852|NCT01702311|O2|Outcome|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
162853|NCT01702311|O1|Outcome|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
162854|NCT01702311|O2|Outcome|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
162855|NCT01702311|O1|Outcome|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
162856|NCT01702311|O2|Outcome|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
162857|NCT01702311|O1|Outcome|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
162858|NCT01702311|O2|Outcome|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
162859|NCT01702311|O1|Outcome|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
162860|NCT01702311|O2|Outcome|no Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (at bedtime) and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
162861|NCT01702311|O1|Outcome|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
162862|NCT01702311|O2|Outcome|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
162863|NCT01702311|O1|Outcome|no Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (at bedtime) and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
162864|NCT01702311|O2|Outcome|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
162865|NCT01702311|O1|Outcome|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
162866|NCT01702311|E2|Reported Event|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
162867|NCT01702311|E1|Reported Event|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
162868|NCT01702298|B1|Baseline|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
162869|NCT01702298|P1|Participant Flow|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
162870|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
162871|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
162872|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
162873|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
162874|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
162875|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
162876|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
162877|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
162878|NCT01702298|E1|Reported Event|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
162879|NCT01702259|B3|Baseline|Total|Total of all reporting groups
162880|NCT01702259|B2|Baseline|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
162881|NCT01702259|B1|Baseline|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
162882|NCT01702259|P2|Participant Flow|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
162883|NCT01702259|P1|Participant Flow|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light."
162884|NCT01702259|O2|Outcome|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
162885|NCT01702259|O1|Outcome|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
162886|NCT01702259|O2|Outcome|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
162887|NCT01702259|O1|Outcome|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
162888|NCT01702259|O2|Outcome|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
162889|NCT01702259|O1|Outcome|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
162890|NCT01702259|O2|Outcome|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
162891|NCT01702259|O1|Outcome|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
162893|NCT01702259|O1|Outcome|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
162894|NCT01702259|E2|Reported Event|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
162895|NCT01702259|E1|Reported Event|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
162896|NCT01702246|B1|Baseline|Simvastatin|"Simvastatin (Zocor), 40mg tablet, 40mg orally once daily, for 3 months~Simvastatin: 40 mg, orally, once daily for 3 months"
162897|NCT01702246|P1|Participant Flow|Simvastatin|"Simvastatin (Zocor), 40mg tablet, 40mg orally once daily, for 3 months~Simvastatin: 40 mg, orally, once daily for 3 months"
162898|NCT01702246|O2|Outcome|Simvastatin Treatment|after treatment with simvastatin: 40 mg, orally, once daily for 3 months
162899|NCT01702246|O1|Outcome|Baseline Cholesterol|mean cholesterol level (mmol/L) prior to treatment with simvastatin
162900|NCT01702246|O2|Outcome|Simvastatin|after treatment with simvastatin: 40 mg, orally, once daily for 3 months
162901|NCT01702246|O1|Outcome|Baseline|prior to treatment with simvastatin
162902|NCT01702246|O2|Outcome|Simvastatin|after treatment with simvastatin: 40 mg, orally, once daily for 3 months
162903|NCT01702246|O1|Outcome|Baseline|prior to treatment with simvastatin
162904|NCT01702246|E1|Reported Event|Simvastatin|"Simvastatin (Zocor), 40mg tablet, 40mg orally once daily, for 3 months~Simvastatin: 40 mg, orally, once daily for 3 months"
162905|NCT01702233|B4|Baseline|Total|Total of all reporting groups
162906|NCT01702233|B3|Baseline|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162907|NCT01702233|B2|Baseline|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
162908|NCT01702233|B1|Baseline|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162909|NCT01702233|P3|Participant Flow|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162910|NCT01702233|P2|Participant Flow|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
162911|NCT01702233|P1|Participant Flow|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162912|NCT01702233|O3|Outcome|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162913|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
162914|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162915|NCT01702233|O3|Outcome|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162916|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
162917|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162918|NCT01702233|O3|Outcome|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162919|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
162920|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162921|NCT01702233|O3|Outcome|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162922|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
162923|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162924|NCT01702233|O3|Outcome|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162925|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
162926|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162927|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
162928|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162929|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
162930|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162931|NCT01702233|O2|Outcome|Saline Inj|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162932|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162933|NCT01702233|O2|Outcome|Saline Inj|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162934|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162935|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
162936|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162937|NCT01702233|O2|Outcome|Saline Inj|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162938|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162939|NCT01702233|O2|Outcome|Saline Inj|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162940|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162941|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
162942|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162943|NCT01702233|E3|Reported Event|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162944|NCT01702233|E2|Reported Event|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
162945|NCT01702233|E1|Reported Event|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
162946|NCT01702025|B5|Baseline|Total|Total of all reporting groups
162947|NCT01702025|B4|Baseline|Aminophylline + Methazolamide|Single dose Aminophylline+Methazolamide Normoxia Minimum 7 day washout Single dose Aminophylline+Methazolamide: Hypoxia
162948|NCT01702025|B3|Baseline|Methazolamide|Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide: Hypoxia
162949|NCT01702025|B2|Baseline|Aminophylline|Single dose Aminophylline Normoxia Minimum 7 day washout Single dose Aminophylline Hypoxia
162950|NCT01702025|B1|Baseline|Placebo|Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo: Hypoxia
162951|NCT01702025|P4|Participant Flow|Aminophylline + Methazolamide|Single dose Aminophylline+Methazolamide Normoxia Minimum 7 day washout Single dose Aminophylline+Methazolamide: Hypoxia
162952|NCT01702025|P3|Participant Flow|Methazolamide|Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide: Hypoxia
162953|NCT01702025|P2|Participant Flow|Aminophylline|Single dose Aminophylline Normoxia Minimum 7 day washout Single dose Aminophylline Hypoxia
162954|NCT01702025|P1|Participant Flow|Placebo|Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo: Hypoxia
162955|NCT01702025|O8|Outcome|Hypoxia Methazolamide/Aminophylline|Methazolamide combined with Aminophylline: single dose hypoxia
162956|NCT01702025|O7|Outcome|Normoxia Methazolamide/Aminophylline|Methazolamide combined with Aminophylline: single dose normoxia
162957|NCT01702025|O6|Outcome|Hypoxia Methazolamide|Methazolamide: single dose hypoxia
162958|NCT01702025|O5|Outcome|Normoxia Methazolamide|Methazolamide single dose Normoxia
162959|NCT01702025|O4|Outcome|Hypoxia Aminophylline|Aminophylline:single dose hypoxia
162960|NCT01702025|O3|Outcome|Normoxia Aminophylline|Aminophylline:single dose Normoxia
162961|NCT01702025|O2|Outcome|Hypoxia Placebo|Placebo: single dose hypoxia
162962|NCT01702025|O1|Outcome|Normoxia Placebo|Placebo: single dose Normoxia
162963|NCT01702025|E4|Reported Event|Aminophylline + Methazolamide|Single dose Aminophylline+Methazolamide Normoxia Minimum 7 day washout Single dose Aminophylline+Methazolamide: Hypoxia
162964|NCT01702025|E3|Reported Event|Methazolamide|Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide Hypoxia
162965|NCT01702025|E2|Reported Event|Aminophylline|Single dose Aminophylline Normoxia Minimum 7 day washout Single dose Aminophylline Hypoxia
162966|NCT01702025|E1|Reported Event|Placebo|Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo Hypoxia
162967|NCT01701999|B3|Baseline|Total|Total of all reporting groups
162968|NCT01701999|B2|Baseline|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
162969|NCT01701999|B1|Baseline|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
162970|NCT01701999|P2|Participant Flow|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
162971|NCT01701999|P1|Participant Flow|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
162972|NCT01701999|O2|Outcome|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
162973|NCT01701999|O1|Outcome|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
162974|NCT01701999|O2|Outcome|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
162975|NCT01701999|O1|Outcome|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
162976|NCT01701999|O2|Outcome|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
162977|NCT01701999|O1|Outcome|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
162978|NCT01701999|O2|Outcome|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
162979|NCT01701999|O1|Outcome|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
162980|NCT01701999|E2|Reported Event|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
163721|NCT01699750|O1|Outcome|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
162981|NCT01701999|E1|Reported Event|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
162982|NCT01701973|B1|Baseline|Participants From All Groups|Data was collected as one group
162983|NCT01701973|P8|Participant Flow|Aim 2: Sitagliptin + Exendin 9-39, Then Sitagliptin + Placebo|In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either Exendin 9-39 versus placebo.
162984|NCT01701973|P7|Participant Flow|Aim 2: Sitagliptin + Placebo, Then Sitagliptin + Exendin 9-39|In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either Exendin 9-39 versus placebo.
162985|NCT01701973|P6|Participant Flow|Aim 2: Sitagliptin + Pegvisomant, Then Sitagliptin + Placebo|In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either pegvisomant versus placebo.
162986|NCT01701973|P5|Participant Flow|Aim 2: Sitagliptin + Placebo, Then Sitagliptin + Pegvisomant|In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either pegvisomant versus placebo.
162987|NCT01701973|P4|Participant Flow|Aim 2:Sitagliptin + LNMMA, Then Sitagliptin + Placebo|In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either L-NMMA (L-N-Monomethyl-arginine) versus placebo.
162988|NCT01701973|P3|Participant Flow|Aim 2: Sitagliptin + Placebo,Then Sitagliptin + LNMMA|In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either L-NMMA (L-N-Monomethyl-arginine) versus placebo.
162989|NCT01701973|P2|Participant Flow|Aim 1: Placebo, Then Sitagliptin|In Aim 1: Healthy Lean adults are randomized in a double-blinded cross over fashion to sitagliptin versus placebo.
162990|NCT01701973|P1|Participant Flow|Aim 1: Sitagliptin, Then Placebo|In Aim 1: Healthy Lean adults are randomized in a double-blinded cross over fashion to sitagliptin versus placebo.
162991|NCT01701973|O2|Outcome|Aim 2: Sitagliptin and Pegvisomant, Female Participants|Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion.
162992|NCT01701973|O1|Outcome|Aim 2: Sitagliptin and Placebo, Females in Pegvisomant Group|Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion.
162993|NCT01701973|O2|Outcome|Aim 2: Sitagliptin and Pegvisomant, Female Participants|Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion.
162994|NCT01701973|O1|Outcome|Aim 2: Sitagliptin and Placebo, Females in Pegvisomant Group|Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion.
162995|NCT01701973|O4|Outcome|Aim 1: Placebo, Male Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. tPA levels were assessed during a 3 hour period following arginine stimulation.
162996|NCT01701973|O3|Outcome|Aim 1: Sitagliptin, Male Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. tPA levels were assessed during a 3 hour period following arginine stimulation.
162997|NCT01701973|O2|Outcome|Aim 1: Placebo, Female Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. tPA levels were assessed during a 3 hour period following arginine stimulation.
162998|NCT01701973|O1|Outcome|Aim 1: Sitagliptin,Female Participants|Subjects undergo two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. tPA levels were assessed during a 3 hour period following arginine stimulation.
162999|NCT01701973|O10|Outcome|Aim 2: Sitagliptin and Placebo, Male in Exendin 9-39 Group|One of the men in Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
163000|NCT01701973|O9|Outcome|Aim 2: Sitagliptin and Exendin 9-39, Male Participant|One of the men in Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
163001|NCT01701973|O8|Outcome|Aim 2: Sitagliptin and Placebo, Females in Exendin 9-39 Group|Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
163002|NCT01701973|O7|Outcome|Aim 2: Sitagliptin and Exendin 9-39, Female Participants|Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
163003|NCT01701973|O6|Outcome|Aim 2: Sitagliptin & Placebo,Females in Pegvisomant Group|Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion. The protocol specified a priori not to study men further if the first seven men randomized to sitagliptin vs. placebo in Aim 1 showed no effect of sitagliptin in men.
163047|NCT01701622|E1|Reported Event|Febuxostat|Febuxostat group. The primary outcome of the study is the 24 hour ABPM differences while participants were taking allopurinol compared to taking febuxostat.
163048|NCT01701505|B7|Baseline|Total|Total of all reporting groups
163004|NCT01701973|O5|Outcome|Aim 2: Sitagliptin and Pegvisomant, Female Participants|Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion. The protocol specified a priori not to study men further if the first seven men randomized to sitagliptin vs. placebo in Aim 1 showed no effect of sitagliptin in men.
163005|NCT01701973|O4|Outcome|Aim 2: Sitagliptin and Placebo, Males in LNMMA Group|Two of the men in Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus L-N-monomethylarginine (LNMMA) and on another sitagliptin plus placebo, in a randomized cross-over fashion.
163006|NCT01701973|O3|Outcome|Aim 2: Sitagliptin and LNMMA, Male Participants|Two of the men in Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus L-N-monomethylarginine (LNMMA) and on another sitagliptin plus placebo, in a randomized cross-over fashion.
163007|NCT01701973|O2|Outcome|Aim 2: Sitagliptin and Placebo, Females in LNMMA Group|Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus LNMMA and on another sitagliptin plus placebo, in a randomized cross-over fashion.
163008|NCT01701973|O1|Outcome|Aim 2: Sitagliptin and LNMMA, Female Participants|Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus LNMMA and on another sitagliptin plus placebo, in a randomized cross-over fashion.
163009|NCT01701973|O10|Outcome|Aim 2: Sitagliptin and Placebo, Male in Exendin 9-39 Group|One of the men from Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
163010|NCT01701973|O9|Outcome|Aim 2: Sitagliptin and Exendin 9-39, Male Participant|One of the men from Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
163011|NCT01701973|O8|Outcome|Aim 2: Sitagliptin and Placebo, Females in Exendin 9-39 Group|Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
163012|NCT01701973|O7|Outcome|Aim 2: Sitagliptin and Exendin 9-39, Female Participants|Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
163013|NCT01701973|O6|Outcome|Aim 2: Sitagliptin & Placebo, Females in Pegvisomant Group|Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion. The protocol specified a priori not to study men further if the first seven men randomized to sitagliptin vs. placebo in Aim 1 showed no effect of sitagliptin in men.
163014|NCT01701973|O5|Outcome|Aim 2: Sitagliptin and Pegvisomant, Female Participants|Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion. The protocol specified a priori not to study men further if the first seven men randomized to sitagliptin vs. placebo in Aim 1 showed no effect of sitagliptin in men.
163015|NCT01701973|O4|Outcome|Aim 2: Sitagliptin and Placebo, Males in LNMMA Group|Two of the men in Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus L-N-monomethylarginine (LNMMA) and on another sitagliptin plus placebo, in a randomized cross-over fashion.
163016|NCT01701973|O3|Outcome|Aim 2: Sitagliptin and LNMMA, Male Participants|Two of the men in Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus L-N-monomethylarginine (LNMMA) and on another sitagliptin plus placebo, in a randomized cross-over fashion.
163017|NCT01701973|O2|Outcome|Aim 2: Sitagliptin and Placebo, Females in LNMMA Group|Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus L-N-monomethylarginine (LNMMA) and on another sitagliptin plus placebo, in a randomized cross-over fashion.
163018|NCT01701973|O1|Outcome|Aim 2: Sitagliptin and LNMMA, Female Participants|Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus L-N-monomethylarginine (LNMMA) and on another sitagliptin plus placebo, in a randomized cross-over fashion.
163019|NCT01701973|O4|Outcome|Aim 1: Placebo, Male Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Forearm blood flow was assessed during a 3 hour period following arginine stimulation.
163020|NCT01701973|O3|Outcome|Aim 1: Sitagliptin, Male Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Forearm blood flow was assessed during a 3 hour period following arginine stimulation.
163021|NCT01701973|O2|Outcome|Aim 1: Placebo, Female Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Forearm blood flow was assessed during a 3 hour period following arginine stimulation.
163022|NCT01701973|O1|Outcome|Aim 1: Sitagliptin,Female Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Forearm blood flow was assessed during a 3 hour period following arginine stimulation.
163023|NCT01701973|O4|Outcome|Aim 1: Placebo, Male Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Forearm vascular resistance (FVR) was assessed during a 3 hour period following arginine stimulation.
163024|NCT01701973|O3|Outcome|Aim 1: Sitagliptin, Male Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Forearm vascular resistance (FVR) was assessed during a 3 hour period following arginine stimulation.
163025|NCT01701973|O2|Outcome|Aim 1: Placebo, Female Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Forearm vascular resistance (FVR) was assessed during a 3 hour period following arginine stimulation.
163026|NCT01701973|O1|Outcome|Aim 1: Sitagliptin,Female Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Forearm vascular resistance (FVR) was assessed during a 3 hour period following arginine stimulation.
163027|NCT01701973|O4|Outcome|Aim 1: Placebo, Male Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
163028|NCT01701973|O3|Outcome|Aim 1: Sitagliptin, Male Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
163029|NCT01701973|O2|Outcome|Aim 1: Placebo, Female Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
163030|NCT01701973|O1|Outcome|Aim 1: Sitagliptin,Female Participants|Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
163031|NCT01701973|E5|Reported Event|Sitagliptin Plus Exendin 9-39|8 participants from Aim 1 returned for an additional two study days in which they were randomized to sitagliptin plus placebo vs. sitagliptin plus Exendin 9-39.
163032|NCT01701973|E4|Reported Event|Sitagliptin Plus LNMMA|9 participants from Aim 1 returned for an additional two study days in which they were randomized to sitagliptin plus placebo vs. sitagliptin plus L-N-mono-methylarginine (LNMMA).
163033|NCT01701973|E3|Reported Event|Sitagliptin Plus Pegvisomant|Five women from Aim 1 returned for an additional two study days in which they were randomized to sitagliptin plus placebo vs. sitagliptin plus pre-treatment with pegvisomant.
163034|NCT01701973|E2|Reported Event|Placebo|Healthy lean adults completed a double blinded cross over study in which they took sitagliptin vs. placebo separated by a wash-out.
163035|NCT01701973|E1|Reported Event|Sitagliptin|Healthy lean adults completed a double blinded cross over study in which they took sitagliptin vs. placebo separated by a wash-out.
163036|NCT01701674|B1|Baseline|Experimental: Combination Therapy|The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
163037|NCT01701674|P1|Participant Flow|Experimental: Combination Therapy|The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
163038|NCT01701674|O1|Outcome|Experimental: Combination Therapy|The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
163039|NCT01701674|O1|Outcome|Experimental: Combination Therapy|The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
163040|NCT01701674|O1|Outcome|Experimental: Combination Therapy|The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
163041|NCT01701674|O1|Outcome|Experimental: Combination Therapy|The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
163042|NCT01701674|E1|Reported Event|Experimental: Combination Therapy|The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
163043|NCT01701622|B1|Baseline|Allopurinol, Febuxostat|"Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.~febuxostat : If baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily.~If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily.~Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks."
163044|NCT01701622|P1|Participant Flow|Allopurinol, Febuxostat|"Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.~febuxostat : If baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily.~If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily.~Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks."
163045|NCT01701622|O1|Outcome|Allopurinol, Febuxostat|"Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.~febuxostat: If baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily.~If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily.~Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks.~as reported earlier (2013), no statistical analysis because of no study participate completion"
163046|NCT01701622|O1|Outcome|Allopurinol, Febuxostat|"Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.~febuxostat: If baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily.~If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily.~Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks."
163049|NCT01701505|B6|Baseline|Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
163050|NCT01701505|B5|Baseline|Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
163051|NCT01701505|B4|Baseline|Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
163052|NCT01701505|B3|Baseline|Cohort A: 12-17 High Dose (400uL Kovacaine Mist)|400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
163053|NCT01701505|B2|Baseline|Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
163054|NCT01701505|B1|Baseline|Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
163055|NCT01701505|P6|Participant Flow|Cohort C: 3-6 Years Low Dose|"120uL of Kovacaine Mist, as 2 sprays of 60uL~120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each"
163056|NCT01701505|P5|Participant Flow|Cohort B: 7-11 Years Med Dose|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
163057|NCT01701505|P4|Participant Flow|Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
163058|NCT01701505|P3|Participant Flow|Cohort A: 12-17 Years HighDose (400uL Kovacaine Mist)|400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each.
163059|NCT01701505|P2|Participant Flow|Cohort A: 12-17 Years Mid-Dose (200uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each.
163060|NCT01701505|P1|Participant Flow|Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each.
163061|NCT01701505|O3|Outcome|Kovacaine Mist Low Dose|"120uL of Kovacaine Mist, as 2 sprays of 60uL.~120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each."
163062|NCT01701505|O2|Outcome|Kovacaine Mist Mid Dose|"200uL of Kovacaine Mist, as 2 sprays of 100uL.~200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each."
163063|NCT01701505|O1|Outcome|Kovacaine Mist High Dose|"400uL of Kovacaine Mist, as 2 sprays of 200uL.~400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each."
163064|NCT01701505|O3|Outcome|Kovacaine Mist Low Dose|"120uL of Kovacaine Mist, as 2 sprays of 60uL.~120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each."
163065|NCT01701505|O2|Outcome|Kovacaine Mist Mid Dose|"200uL of Kovacaine Mist, as 2 sprays of 100uL.~200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each."
163066|NCT01701505|O1|Outcome|Kovacaine Mist High Dose|"400uL of Kovacaine Mist, as 2 sprays of 200uL.~400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each."
163067|NCT01701505|O6|Outcome|Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
163068|NCT01701505|O5|Outcome|Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
163069|NCT01701505|O4|Outcome|Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
163070|NCT01701505|O3|Outcome|Cohort A: 12-17 High Dose (400uL Kovacaine Mist)|400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
163071|NCT01701505|O2|Outcome|Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
163072|NCT01701505|O1|Outcome|Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
163073|NCT01701505|O6|Outcome|Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
163074|NCT01701505|O5|Outcome|Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
163075|NCT01701505|O4|Outcome|Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
163076|NCT01701505|O3|Outcome|Cohort A: 12-17 High Dose (400uL Kovacaine Mist)|400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
163077|NCT01701505|O2|Outcome|Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
163078|NCT01701505|O1|Outcome|Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
163079|NCT01701505|O6|Outcome|Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
163080|NCT01701505|O5|Outcome|Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
163081|NCT01701505|O4|Outcome|Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
163082|NCT01701505|O3|Outcome|Cohort A: 12-17 High Dose (400uL Kovacaine Mist)|400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
163083|NCT01701505|O2|Outcome|Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
163084|NCT01701505|O1|Outcome|Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
163085|NCT01701505|O6|Outcome|Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
163086|NCT01701505|O5|Outcome|Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
163087|NCT01701505|O4|Outcome|Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
163088|NCT01701505|O3|Outcome|Cohort A: 12-17 High Dose (400uL Kovacaine Mist)|400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
163089|NCT01701505|O2|Outcome|Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
163090|NCT01701505|O1|Outcome|Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
163091|NCT01701505|O6|Outcome|Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
163092|NCT01701505|O5|Outcome|Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
163093|NCT01701505|O4|Outcome|Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
163094|NCT01701505|O3|Outcome|Cohort A: 12-17 High Dose (400uL Kovacaine Mist)|400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
163095|NCT01701505|O2|Outcome|Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
163096|NCT01701505|O1|Outcome|Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
163097|NCT01701505|O6|Outcome|Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
163098|NCT01701505|O5|Outcome|Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
163099|NCT01701505|O4|Outcome|Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
163100|NCT01701505|O3|Outcome|Cohort A: 12-17 High Dose (400uL Kovacaine Mist)|400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
163101|NCT01701505|O2|Outcome|Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
163102|NCT01701505|O1|Outcome|Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
163103|NCT01701505|E6|Reported Event|Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
163104|NCT01701505|E5|Reported Event|Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
163105|NCT01701505|E4|Reported Event|Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
163106|NCT01701505|E3|Reported Event|Cohort A: 12-17 High Dose (400uL Kovacaine Mist)|400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
163107|NCT01701505|E2|Reported Event|Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
163108|NCT01701505|E1|Reported Event|Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
163109|NCT01701414|B3|Baseline|Total|Total of all reporting groups
163110|NCT01701414|B2|Baseline|Standard Care (SC)|"The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.~Placebo: 3cc of 0.9% Normal Saline : 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice"
163111|NCT01701414|B1|Baseline|Femoral Nerve Block (FNB)|"Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name 3-in-1 femoral block is often used), providing maximum analgesia to the hip.~Femoral nerve block: 25 mL of 0.5% bupivacaine : 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks."
163112|NCT01701414|P2|Participant Flow|Standard Care (SC)|"The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.~Placebo: 3cc of 0.9% Normal Saline : 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice"
163113|NCT01701414|P1|Participant Flow|Femoral Nerve Block (FNB)|"Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name 3-in-1 femoral block is often used), providing maximum analgesia to the hip.~Femoral nerve block: 25 mL of 0.5% bupivacaine : 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks."
163114|NCT01701414|O2|Outcome|Standard Care (SC)|"The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.~Placebo: 3cc of 0.9% Normal Saline : 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice"
163149|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
163150|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
163151|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
163152|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
183474|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
163115|NCT01701414|O1|Outcome|Femoral Nerve Block (FNB)|"Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name 3-in-1 femoral block is often used), providing maximum analgesia to the hip.~Femoral nerve block: 25 mL of 0.5% bupivacaine : 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks."
163116|NCT01701414|E2|Reported Event|Standard Care (SC)|"The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.~Placebo: 3cc of 0.9% Normal Saline : 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice"
163117|NCT01701414|E1|Reported Event|Femoral Nerve Block (FNB)|"Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name 3-in-1 femoral block is often used), providing maximum analgesia to the hip.~Femoral nerve block: 25 mL of 0.5% bupivacaine : 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks."
163118|NCT01701401|B5|Baseline|Total|Total of all reporting groups
163119|NCT01701401|B4|Baseline|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
163120|NCT01701401|B3|Baseline|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
163121|NCT01701401|B2|Baseline|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
163122|NCT01701401|B1|Baseline|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
163123|NCT01701401|P4|Participant Flow|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
163124|NCT01701401|P3|Participant Flow|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
163125|NCT01701401|P2|Participant Flow|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
163126|NCT01701401|P1|Participant Flow|LDV/SOF 12 Weeks|Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg FDC tablet once daily for 12 weeks
163127|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
163128|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
163129|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
163130|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
163131|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
163132|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
163133|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
163134|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
163135|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
163136|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
163137|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
163138|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
163139|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
163140|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
163141|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
163142|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
163143|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
163144|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
163145|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
163146|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
163147|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
163148|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
163153|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
163154|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
163155|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
163156|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
163157|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
163158|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
163159|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
163160|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
163161|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
163162|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
163163|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
163164|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
163165|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
163166|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
163167|NCT01701401|E4|Reported Event|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
163168|NCT01701401|E3|Reported Event|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
163169|NCT01701401|E2|Reported Event|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
163170|NCT01701401|E1|Reported Event|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
163171|NCT01701375|B1|Baseline|Arm 1|"PD 0332991 will be given orally days 1,2,3~Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6~Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose"
163172|NCT01701375|P1|Participant Flow|Arm 1|"PD 0332991 125 was given orally days 1,2,3~Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6~Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose"
163173|NCT01701375|O1|Outcome|Arm 1|"PD 0332991 will be given orally days 1,2,3~Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6~Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose"
163174|NCT01701375|E1|Reported Event|Arm 1|"PD 0332991 will be given orally days 1,2,3~Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6~Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose"
163175|NCT01701362|B3|Baseline|Total|Total of all reporting groups
163176|NCT01701362|B2|Baseline|Placebo|Participants randomized to receive placebo
163177|NCT01701362|B1|Baseline|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
163178|NCT01701362|P2|Participant Flow|Placebo|Participants randomized to receive placebo
163179|NCT01701362|P1|Participant Flow|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
163180|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
163181|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
163182|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
163183|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
163184|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
163185|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
163186|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
163187|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
163188|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
163189|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
163190|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
163191|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
163192|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
163193|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
163194|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
163195|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
163196|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
163197|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
163198|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
163199|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
163200|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
163201|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
163202|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
163203|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
163204|NCT01701362|E2|Reported Event|Placebo|Participants randomized to receive placebo
163205|NCT01701362|E1|Reported Event|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
163206|NCT01701271|B1|Baseline|Volunteers|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
163207|NCT01701271|P1|Participant Flow|Volunteers Evaluated|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
163208|NCT01701271|O1|Outcome|Volunteers|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
163209|NCT01701271|O1|Outcome|Volunteers Evaluated|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
163210|NCT01701271|O1|Outcome|Volunteers|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
163211|NCT01701271|E1|Reported Event|Volunteers|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
163212|NCT01701258|B5|Baseline|Total|Total of all reporting groups
163213|NCT01701258|B4|Baseline|CSA/MDD Group|Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge.
163214|NCT01701258|B3|Baseline|CSA/RES Group|Subjects with a history of CSA but no psychopathology (“resilient group”; CSA/RES).
163215|NCT01701258|B2|Baseline|MDD Group|Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge.
163216|NCT01701258|B1|Baseline|Control Group|Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.
163217|NCT01701258|P13|Participant Flow|CSA/MDD-placebo (fMRI Session)|"After the screening visit, eligible subjects with a current episode of major depression (MDD) with a history of child sexual abuse (CSA) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo. This arm is specific to those that competed the fMRI session.~Many eligible CSA/MDD baseline participants did not complete this session."
163218|NCT01701258|P12|Participant Flow|CSA/MDD-amisulpride (fMRI Session)|After the screening visit, eligible subjects with a current episode of major depression (MDD) with a history of child sexual abuse (CSA) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.This arm is specific to those that competed the fMRI session. Many eligible CSA/MDD baseline participants did not complete this session.
163219|NCT01701258|P11|Participant Flow|CSA/MDD Group|Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA).
163220|NCT01701258|P10|Participant Flow|CSA/RES-placebo (fMRI Session)|"After the screening visit, eligible subjects with a history of CSA but no psychopathology (resilient group; CSA/RES) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible CSA/RES baseline participants did not complete this session."
163221|NCT01701258|P9|Participant Flow|CSA/RES-amisulpride (fMRI Session)|"After the screening visit, eligible subjects with a history of CSA but no psychopathology (resilient group; CSA/RES) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.This arm is specific to those that competed the fMRI session. Many eligible CSA/RES baseline participants did not complete this session."
163222|NCT01701258|P8|Participant Flow|CSA/RES|Subjects with a history of CSA but no psychopathology (“resilient group”; CSA/RES).
163223|NCT01701258|P7|Participant Flow|MDD-placebo (fMRI Session)|After the screening visit, eligible subjects without a history of child sexual abuse that are currently experiencing a major depressive episode were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible MDD baseline participants did not complete this session.
164475|NCT01696643|O1|Outcome|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
163224|NCT01701258|P6|Participant Flow|MDD-amisulpride (fMRI Session)|After the screening visit, eligible subjects without a history of child sexual abuse that are currently experiencing a major depressive episode were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible MDD baseline participants did not complete this session.
163225|NCT01701258|P5|Participant Flow|MDD Group|Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode .
163226|NCT01701258|P4|Participant Flow|Control-placebo (fMRI Session)|After the screening visit, eligible control subjects without a history of child sexual abuse and without a current or past diagnosis of major depression were invited to participate in the fMRI session. Those that were interested were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible baseline control participants did not complete this session.
163227|NCT01701258|P3|Participant Flow|Control-amisulpride (fMRI Session)|After the screening visit, eligible control subjects without a history of child sexual abuse and without a current or past diagnosis of major depression were invited to participate in the fMRI session. Those that were interested were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible baseline control participants did not complete this session.
163228|NCT01701258|P2|Participant Flow|Control Group|Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.
163229|NCT01701258|P1|Participant Flow|All Participants|All participants that went through the assessment (session 1) regardless if they were eligible or ineligible.
163230|NCT01701258|O4|Outcome|CSA/MDD Group|Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge.
163231|NCT01701258|O3|Outcome|CSA/RES Group|Subjects with a history of CSA but no psychopathology (“resilient group”; CSA/RES).
163232|NCT01701258|O2|Outcome|MDD Group|Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge.
163233|NCT01701258|O1|Outcome|Control Group|Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.
163234|NCT01701258|O8|Outcome|Control-placebo|"Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a placebo during the fMRI session.~Placebo: single-dose placebo capsule during the fMRI session only"
163235|NCT01701258|O7|Outcome|Control-amisulpride|"Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.~Amisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only"
163236|NCT01701258|O6|Outcome|MDD-placebo|"Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a placebo during the fMRI session.~Placebo: single-dose placebo capsule during the fMRI session only"
163237|NCT01701258|O5|Outcome|MDD-amisulpride|"Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.~Amisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only"
163238|NCT01701258|O4|Outcome|CSA/RES-placebo|"Subjects with a history of child sexual abuse (CSA) without a current or past diagnosis of major depressive disorder (RES) are randomized to receive a placebo during the fMRI session.~Placebo: single-dose placebo capsule during the fMRI session only"
163239|NCT01701258|O3|Outcome|CSA/RES-amisulpride|"Subjects with a history of child sexual abuse (CSA) without a current or past diagnosis of major depressive disorder (RES) are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.~Amisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only"
163240|NCT01701258|O2|Outcome|CSA/MDD-placebo|"Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a placebo during the fMRI session.~Placebo: single-dose placebo capsule during the fMRI session only"
163241|NCT01701258|O1|Outcome|CSA/MDD-amisulpride|"Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.~Amisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only"
163242|NCT01701258|O8|Outcome|Control-placebo|"Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a placebo during the fMRI session.~Placebo: single-dose placebo capsule during the fMRI session only"
163243|NCT01701258|O7|Outcome|Control-amisulpride|"Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.~Amisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only"
163244|NCT01701258|O6|Outcome|MDD-placebo|"Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a placebo during the fMRI session.~Placebo: single-dose placebo capsule during the fMRI session only"
163245|NCT01701258|O5|Outcome|MDD-amisulpride|"Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.~Amisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only"
163246|NCT01701258|O4|Outcome|CSA/RES-placebo|"Subjects with a history of child sexual abuse (CSA) without a current or past diagnosis of major depressive disorder (RES) are randomized to receive a placebo during the fMRI session.~Placebo: single-dose placebo capsule during the fMRI session only"
163430|NCT01700907|E1|Reported Event|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
163247|NCT01701258|O3|Outcome|CSA/RES-amisulpride|"Subjects with a history of child sexual abuse (CSA) without a current or past diagnosis of major depressive disorder (RES) are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.~Amisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only"
163248|NCT01701258|O2|Outcome|CSA/MDD-placebo|"Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a placebo during the fMRI session.~Placebo: single-dose placebo capsule during the fMRI session only"
163249|NCT01701258|O1|Outcome|CSA/MDD-amisulpride|"Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.~Amisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only"
163250|NCT01701258|O4|Outcome|CSA/MDD Group|Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge.
163251|NCT01701258|O3|Outcome|CSA/RES Group|Subjects with a history of CSA but no psychopathology (“resilient group”; CSA/RES).
163252|NCT01701258|O2|Outcome|MDD Group|Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge.
163253|NCT01701258|O1|Outcome|Control Group|Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.
163254|NCT01701258|O4|Outcome|CSA/MDD Group|Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge.
163255|NCT01701258|O3|Outcome|CSA/RES Group|Subjects with a history of CSA but no psychopathology (“resilient group”; CSA/RES).
163256|NCT01701258|O2|Outcome|MDD Group|Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge.
163257|NCT01701258|O1|Outcome|Control Group|Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.
163258|NCT01701258|O4|Outcome|CSA/MDD Group|Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge.
163259|NCT01701258|O3|Outcome|CSA/RES Group|Subjects with a history of CSA but no psychopathology (“resilient group”; CSA/RES).
163260|NCT01701258|O2|Outcome|MDD Group|Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge.
163261|NCT01701258|O1|Outcome|Control Group|Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.
163262|NCT01701258|O4|Outcome|CSA/MDD Group|Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge.
163263|NCT01701258|O3|Outcome|CSA/RES Group|Subjects with a history of CSA but no psychopathology (“resilient group”; CSA/RES).
163264|NCT01701258|O2|Outcome|MDD Group|Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge.
163265|NCT01701258|O1|Outcome|Control Group|Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.
163266|NCT01701258|E14|Reported Event|CSA/MDD-placebo (fMRI Session)|"After the screening visit, eligible subjects with a current episode of major depression (MDD) with a history of child sexual abuse (CSA) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo. This arm is specific to those that competed the fMRI session.~Many eligible CSA/MDD baseline participants did not complete this session."
163267|NCT01701258|E13|Reported Event|CSA/MDD-amisulpride (fMRI Session)|After the screening visit, eligible subjects with a current episode of major depression (MDD) with a history of child sexual abuse (CSA) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.This arm is specific to those that competed the fMRI session. Many eligible CSA/MDD baseline participants did not complete this session.
163268|NCT01701258|E12|Reported Event|CSA/MDD Group|Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA). These participants were eligible after the screening session (session 1) and are accounted for regardless if they completed other study sessions.
163269|NCT01701258|E11|Reported Event|CSA/RES-placebo (fMRI Session)|"After the screening visit, eligible subjects with a history of CSA but no psychopathology (resilient group; CSA/RES) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible CSA/RES baseline participants did not complete this session."
163270|NCT01701258|E10|Reported Event|CSA/RES-amisulpride (fMRI Session)|"After the screening visit, eligible subjects with a history of CSA but no psychopathology (resilient group; CSA/RES) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.This arm is specific to those that competed the fMRI session. Many eligible CSA/RES baseline participants did not complete this session."
163271|NCT01701258|E9|Reported Event|CSA/RES|"Subjects with a history of CSA but no psychopathology (resilient group; CSA/RES). These participants were eligible after the screening session (session 1) and are accounted for regardless if they completed other study sessions."
163272|NCT01701258|E8|Reported Event|MDD-placebo (fMRI Session)|After the screening visit, eligible subjects without a history of child sexual abuse that are currently experiencing a major depressive episode were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible MDD baseline participants did not complete this session.
163431|NCT01700816|B3|Baseline|Total|Total of all reporting groups
163273|NCT01701258|E7|Reported Event|MDD-amisulpride (fMRI Session)|After the screening visit, eligible subjects without a history of child sexual abuse that are currently experiencing a major depressive episode were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible MDD baseline participants did not complete this session.
163274|NCT01701258|E6|Reported Event|MDD Group|Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode. These participants were eligible after the screening session (session 1) and are accounted for regardless if they completed other study sessions.
163275|NCT01701258|E5|Reported Event|Control-placebo (fMRI Session)|After the screening visit, eligible control subjects without a history of child sexual abuse and without a current or past diagnosis of major depression were invited to participate in the fMRI session. Those that were interested, were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible baseline control participants did not complete this session.
163276|NCT01701258|E4|Reported Event|Control-amisulpride (fMRI Session)|After the screening visit, eligible control subjects without a history of child sexual abuse and without a current or past diagnosis of major depression were invited to participate in the fMRI session. Those that were interested, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible baseline control participants did not complete this session.
163277|NCT01701258|E3|Reported Event|Control Group|Control subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode. These participants were eligible after the screening session (session 1) and are accounted for regardless if they completed other study sessions.
163278|NCT01701258|E2|Reported Event|All Baseline Participants|Participants that were eligible for the study after the screening visit (session 1). These participants were invited to participate in the other study sessions.
163279|NCT01701258|E1|Reported Event|All Participants|All participants that went through the assessment (session 1) regardless if they were eligible or ineligible.
163280|NCT01701245|B3|Baseline|Total|Total of all reporting groups
163281|NCT01701245|B2|Baseline|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.~GammaCore: vagal stimulation"
163282|NCT01701245|B1|Baseline|Standard of Care|No intervention, standard of care
163283|NCT01701245|P2|Participant Flow|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.~GammaCore: vagal stimulation"
163284|NCT01701245|P1|Participant Flow|Standard of Care|No intervention, standard of care
163285|NCT01701245|O2|Outcome|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.~GammaCore: vagal stimulation"
163286|NCT01701245|O1|Outcome|Standard of Care|No intervention, standard of care
163287|NCT01701245|O2|Outcome|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.~GammaCore: vagal stimulation"
163288|NCT01701245|O1|Outcome|Standard of Care|No intervention, standard of care
163289|NCT01701245|O2|Outcome|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.~GammaCore: vagal stimulation"
163290|NCT01701245|O1|Outcome|Standard of Care|No intervention, standard of care
163291|NCT01701245|O2|Outcome|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.~GammaCore: vagal stimulation"
163292|NCT01701245|O1|Outcome|Standard of Care|No intervention, standard of care
163293|NCT01701245|E2|Reported Event|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.~GammaCore: vagal stimulation"
163294|NCT01701245|E1|Reported Event|Standard of Care|No intervention, standard of care
163295|NCT01701115|B3|Baseline|Total|Total of all reporting groups
163296|NCT01701115|B2|Baseline|Control Dose (40 mL) Local Anesthetic|"Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine~Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:~Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL~Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)"
163297|NCT01701115|B1|Baseline|Low Dose (20 mL) Local Anesthetic|"Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine.~Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:~Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL~Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)"
163298|NCT01701115|P2|Participant Flow|Control Dose (40 mL) Local Anesthetic|"Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine~Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:~Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL~Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)"
163299|NCT01701115|P1|Participant Flow|Low Dose (20 mL) Local Anesthetic|"Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine.~Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:~Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL~Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)"
163300|NCT01701115|O2|Outcome|Control Dose (40 mL) Local Anesthetic|"Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine~Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:~Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL~Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)"
163301|NCT01701115|O1|Outcome|Low Dose (20 mL) Local Anesthetic|"Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine.~Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:~Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL~Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)"
163302|NCT01701115|O2|Outcome|Control Dose (40 mL) Local Anesthetic|"Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine~Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:~Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL~Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)"
163303|NCT01701115|O1|Outcome|Low Dose (20 mL) Local Anesthetic|"Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine.~Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:~Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL~Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)"
163304|NCT01701115|O2|Outcome|Control Dose (40 mL) Local Anesthetic|"Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine~Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:~Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL~Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)"
163305|NCT01701115|O1|Outcome|Low Dose (20 mL) Local Anesthetic|"Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine.~Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:~Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL~Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)"
163306|NCT01701115|O2|Outcome|Control Dose (40 mL) Local Anesthetic|"Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine~Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:~Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL~Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)"
163307|NCT01701115|O1|Outcome|Low Dose (20 mL) Local Anesthetic|"Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine.~Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:~Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL~Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)"
163308|NCT01701115|E2|Reported Event|Control Dose (40 mL) Local Anesthetic|"Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine~Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:~Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL~Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)"
163309|NCT01701115|E1|Reported Event|Low Dose (20 mL) Local Anesthetic|"Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine.~Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:~Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL~Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)"
163310|NCT01701102|B5|Baseline|Total|Total of all reporting groups
163311|NCT01701102|B4|Baseline|Mepivacaine 24 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
163312|NCT01701102|B3|Baseline|Mepivacaine 27 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
163313|NCT01701102|B2|Baseline|Mepivacaine 30 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
163314|NCT01701102|B1|Baseline|Mepivacaine 37.5 mg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
163315|NCT01701102|P4|Participant Flow|Mepivacaine 24 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 mg) and fentanyl (10 µg)
163316|NCT01701102|P3|Participant Flow|Mepivacaine 27 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (27 mg) and fentanyl (10 µg)
163317|NCT01701102|P2|Participant Flow|Mepivacaine 30 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (30 mg) and fentanyl (10 µg)
163318|NCT01701102|P1|Participant Flow|Mepivacaine 37.5 mg|Mepivacaine (37.5 mg)
163319|NCT01701102|O4|Outcome|Mepivacaine 24 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
163320|NCT01701102|O3|Outcome|Mepivacaine 27 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
163321|NCT01701102|O2|Outcome|Mepivacaine 30 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
163322|NCT01701102|O1|Outcome|Mepivacaine 37.5 mg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
163323|NCT01701102|E4|Reported Event|Mepivacaine 24 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
163324|NCT01701102|E3|Reported Event|Mepivacaine 27 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
163325|NCT01701102|E2|Reported Event|Mepivacaine 30 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
163326|NCT01701102|E1|Reported Event|Mepivacaine 37.5 mg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
163327|NCT01701063|B4|Baseline|Total|Total of all reporting groups
163328|NCT01701063|B3|Baseline|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163432|NCT01700816|B2|Baseline|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am~Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
163329|NCT01701063|B2|Baseline|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163330|NCT01701063|B1|Baseline|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163331|NCT01701063|P3|Participant Flow|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163332|NCT01701063|P2|Participant Flow|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163333|NCT01701063|P1|Participant Flow|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 milligram per kilogram [mg/kg] of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with pegylated interferon alfa 2b (Peg-IFN-alfa-2b) 60 microgram per meter square (mcg/m^2) subcutaneous injection weekly and ribavirin (RBV) 200 mg capsules or 40 milligram per milliliter (mg/mL) solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved extended rapid virologic response (eRVR) or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) levels at Week 4 and Week 12.
163334|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163335|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163336|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163337|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163338|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163339|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163380|NCT01701037|O1|Outcome|Dabrafenib and Trametinib|"Patients receive dabrafenib PO BID on days 1-28 adding trametinib on days 15-28 followed by surgery on days 28-30. Treatment continues in the absence of unacceptable toxicity.~dabrafenib: 150 mg given PO~trametinib: 2 mg given PO~laboratory biomarker analysis: Correlative studies"
163556|NCT01700192|O2|Outcome|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
163340|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163341|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163342|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163343|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163344|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163345|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163346|NCT01701063|O1|Outcome|Overall Participants|Participants aged 3 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 to 18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163347|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163348|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163349|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163350|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163351|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163557|NCT01700192|O1|Outcome|MK-8237|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
163352|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163353|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163354|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163355|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163356|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163357|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163358|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163359|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163360|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163361|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163362|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163363|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163722|NCT01699750|O2|Outcome|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
163364|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163365|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163366|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163367|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163368|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163369|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163370|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163371|NCT01701063|E3|Reported Event|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163372|NCT01701063|E2|Reported Event|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163373|NCT01701063|E1|Reported Event|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
163374|NCT01701037|B1|Baseline|Basic Science (Dabrafenib, Trametinib)|"Patients receive dabrafenib PO BID on days 1-28 adding trametinib on days 15-28 followed by surgery on days 28-30. Treatment continues in the absence of unacceptable toxicity.~dabrafenib: 150 mg given PO~trametinib: 2 mg given PO~laboratory biomarker analysis: Correlative studies"
163375|NCT01701037|P1|Participant Flow|Basic Science (Dabrafenib, Trametinib)|"Patients receive dabrafenib PO BID on days 1-28 adding trametinib on days 15-28 followed by surgery on days 28-30. Treatment continues in the absence of unacceptable toxicity.~dabrafenib: 150 mg given PO~trametinib: 2 mg given PO~laboratory biomarker analysis: Correlative studies"
163376|NCT01701037|O1|Outcome|Dabrafenib and Trametinib|
163377|NCT01701037|O1|Outcome|Dabrafenib and Trametinib|
163378|NCT01701037|O1|Outcome|Dabrafenib and Trametinib|"Patients receive dabrafenib PO BID on days 1-28 adding trametinib on days 15-28 followed by surgery on days 28-30. Treatment continues in the absence of unacceptable toxicity.~dabrafenib: 150 mg given PO~trametinib: 2 mg given PO~laboratory biomarker analysis: Correlative studies"
163379|NCT01701037|O1|Outcome|Dabrafenib and Trametinib|
163381|NCT01701037|O1|Outcome|Dabrafenib and Trametinib|"Patients receive dabrafenib PO BID on days 1-28 adding trametinib on days 15-28 followed by surgery on days 28-30. Treatment continues in the absence of unacceptable toxicity.~dabrafenib: 150 mg given PO~trametinib: 2 mg given PO~laboratory biomarker analysis: Correlative studies"
163382|NCT01701037|E1|Reported Event|Basic Science (Dabrafenib, Trametinib)|"Patients receive dabrafenib PO BID on days 1-28 adding trametinib on days 15-28 followed by surgery on days 28-30. Treatment continues in the absence of unacceptable toxicity.~dabrafenib: 150 mg given PO~trametinib: 2 mg given PO~laboratory biomarker analysis: Correlative studies"
163383|NCT01701024|B3|Baseline|Total|Total of all reporting groups
163384|NCT01701024|B2|Baseline|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
163385|NCT01701024|B1|Baseline|ACYC|ACYC active, topically applied to the face for 12 weeks
163386|NCT01701024|P2|Participant Flow|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
163387|NCT01701024|P1|Participant Flow|ACYC|ACYC active, topically applied to the face for 12 weeks
163388|NCT01701024|O2|Outcome|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
163389|NCT01701024|O1|Outcome|ACYC|ACYC active, topically applied to the face for 12 weeks
163390|NCT01701024|O2|Outcome|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
163391|NCT01701024|O1|Outcome|ACYC|ACYC active, topically applied to the face for 12 weeks
163392|NCT01701024|O2|Outcome|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
163393|NCT01701024|O1|Outcome|ACYC|ACYC active, topically applied to the face for 12 weeks
163394|NCT01701024|O2|Outcome|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
163395|NCT01701024|O1|Outcome|ACYC|ACYC active, topically applied to the face for 12 weeks
163396|NCT01701024|E2|Reported Event|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
163397|NCT01701024|E1|Reported Event|ACYC|ACYC active, topically applied to the face for 12 weeks
163398|NCT01701011|B4|Baseline|Total|Total of all reporting groups
163399|NCT01701011|B3|Baseline|Routine Care Control Group|"Questionnaires~Coping intervention, Daily Record Keeping, Questionnaires :"
163400|NCT01701011|B2|Baseline|Monitoring-control Group|"DRK and Questionnaires~Coping intervention, Daily Record Keeping, Questionnaires :"
163401|NCT01701011|B1|Baseline|PRCI-monitoring Group|"Coping intervention, Daily Record Keeping, Questionnaires~Coping intervention, Daily Record Keeping, Questionnaires :"
163402|NCT01701011|P3|Participant Flow|Routine Care Control Group|Patients receive only questionnaires
163403|NCT01701011|P2|Participant Flow|Monitoring-control Group|Daily Record Keeping and Questionnaires
163404|NCT01701011|P1|Participant Flow|PRCI-monitoring Group|Coping intervention, Daily Record Keeping, Questionnaires
163405|NCT01701011|O3|Outcome|Routine Care Control Group|Patients receive only questionnaires
163406|NCT01701011|O2|Outcome|Monitoring-control Group|Daily Record Keeping and Questionnaires
163407|NCT01701011|O1|Outcome|PRCI-monitoring Group|Coping intervention, Daily Record Keeping, Questionnaires
163408|NCT01701011|O3|Outcome|Routine Care Control Group|patients receive questionnaires
163409|NCT01701011|O2|Outcome|Monitoring-control Group|Daily Record Keeping and Questionnaires
163410|NCT01701011|O1|Outcome|PRCI-monitoring Group|Coping intervention, Daily Record Keeping, Questionnaires
163411|NCT01701011|E3|Reported Event|Routine Care Control Group|patients received questionnaires
163412|NCT01701011|E2|Reported Event|Monitoring-control Group|Daily Record Keeping and Questionnaires
163413|NCT01701011|E1|Reported Event|PRCI-monitoring Group|Coping intervention, Daily Record Keeping, Questionnaires
163414|NCT01700907|B3|Baseline|Total|Total of all reporting groups
163415|NCT01700907|B2|Baseline|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
163416|NCT01700907|B1|Baseline|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
163417|NCT01700907|P2|Participant Flow|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
163418|NCT01700907|P1|Participant Flow|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
163419|NCT01700907|O2|Outcome|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
163420|NCT01700907|O1|Outcome|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
163421|NCT01700907|O2|Outcome|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
163422|NCT01700907|O1|Outcome|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
163423|NCT01700907|O2|Outcome|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
163424|NCT01700907|O1|Outcome|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
163425|NCT01700907|O2|Outcome|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
163426|NCT01700907|O1|Outcome|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
163427|NCT01700907|O2|Outcome|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
163428|NCT01700907|O1|Outcome|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
163429|NCT01700907|E2|Reported Event|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
164476|NCT01696643|O2|Outcome|Placebo|Placebo, administered orally, BID for 52 weeks
163433|NCT01700816|B1|Baseline|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am~Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
163434|NCT01700816|P2|Participant Flow|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am~Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
163435|NCT01700816|P1|Participant Flow|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am~Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
163436|NCT01700816|O2|Outcome|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am~Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
163437|NCT01700816|O1|Outcome|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am~Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
163438|NCT01700816|O2|Outcome|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am~Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
163439|NCT01700816|O1|Outcome|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am~Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
163440|NCT01700816|O2|Outcome|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am~Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
163441|NCT01700816|O1|Outcome|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am~Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
163442|NCT01700816|O2|Outcome|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am~Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
163443|NCT01700816|O1|Outcome|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am~Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
163444|NCT01700816|O2|Outcome|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am~Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
163445|NCT01700816|O1|Outcome|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am~Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
163446|NCT01700816|O2|Outcome|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am~Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
163447|NCT01700816|O1|Outcome|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am~Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
163448|NCT01700816|O2|Outcome|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am~Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
163449|NCT01700816|O1|Outcome|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am~Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
163450|NCT01700816|O2|Outcome|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am~Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
163451|NCT01700816|O1|Outcome|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am~Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
163452|NCT01700816|O2|Outcome|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am~Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
163453|NCT01700816|O1|Outcome|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am~Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
163454|NCT01700816|O2|Outcome|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am~Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
163455|NCT01700816|O1|Outcome|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am~Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
163456|NCT01700816|O2|Outcome|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am~Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
163457|NCT01700816|O1|Outcome|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am~Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
163458|NCT01700816|E2|Reported Event|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am~Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
163459|NCT01700816|E1|Reported Event|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am~Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
163460|NCT01700530|B4|Baseline|Total|Total of all reporting groups
164477|NCT01696643|O1|Outcome|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
163461|NCT01700530|B3|Baseline|Statins + Exercise|"Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks~Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks"
163462|NCT01700530|B2|Baseline|Exercise Only|"12 weeks of exercise training (5 days a week for 45-50 min a session)~Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)"
163463|NCT01700530|B1|Baseline|Statin|"Statins (40mg/day)for an average of 12 weeks~Statin: Statins (40mg/day)for 12 weeks"
163464|NCT01700530|P3|Participant Flow|Statins + Exercise|"Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks~Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks"
163465|NCT01700530|P2|Participant Flow|Exercise Only|"12 weeks of exercise training (5 days a week for 45-50 min a session)~Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)"
163466|NCT01700530|P1|Participant Flow|Statin|"Statins (40mg/day)for an average of 12 weeks~Statin: Statins (40mg/day)for 12 weeks"
163467|NCT01700530|O3|Outcome|Statins + Exercise|"Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks~Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks"
163468|NCT01700530|O2|Outcome|Exercise Only|"12 weeks of exercise training (5 days a week for 45-50 min a session)~Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)"
163469|NCT01700530|O1|Outcome|Statin|"Statins (40mg/day)for an average of 12 weeks~Statin: Statins (40mg/day)for 12 weeks"
163470|NCT01700530|O3|Outcome|Statins + Exercise|"Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks~Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks"
163471|NCT01700530|O2|Outcome|Exercise Only|"12 weeks of exercise training (5 days a week for 45-50 min a session)~Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)"
163472|NCT01700530|O1|Outcome|Statin|"Statins (40mg/day)for an average of 12 weeks~Statin: Statins (40mg/day)for 12 weeks"
163473|NCT01700530|E3|Reported Event|Statins + Exercise|"Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks~Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks"
163474|NCT01700530|E2|Reported Event|Exercise Only|"12 weeks of exercise training (5 days a week for 45-50 min a session)~Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)"
163475|NCT01700530|E1|Reported Event|Statin|"Statins (40mg/day)for an average of 12 weeks~Statin: Statins (40mg/day)for 12 weeks"
163476|NCT01700517|B4|Baseline|Total|Total of all reporting groups
163477|NCT01700517|B3|Baseline|Sciatic Nerves Block|"In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine.~sciatic nerves block : sciatic nerves block~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block"
163478|NCT01700517|B2|Baseline|Control Group|"Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication.~Spinal anesthesia : spinal anesthesia"
163479|NCT01700517|B1|Baseline|Femoral Nerve Block|"In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine.~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block"
163480|NCT01700517|P3|Participant Flow|Sciatic Nerves Block|"In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine.~sciatic nerves block : sciatic nerves block~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block"
163481|NCT01700517|P2|Participant Flow|Control Group|"Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication.~Spinal anesthesia : spinal anesthesia"
163482|NCT01700517|P1|Participant Flow|Femoral Nerve Block|"In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine.~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block"
163483|NCT01700517|O3|Outcome|Sciatic Nerves Block|"In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine.~sciatic nerves block : sciatic nerves block~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block~To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed."
163558|NCT01700192|O2|Outcome|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
163559|NCT01700192|O1|Outcome|MK-8237|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
163560|NCT01700192|E2|Reported Event|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
164478|NCT01696643|O2|Outcome|Placebo|Placebo, administered orally, BID for 52 weeks
163484|NCT01700517|O2|Outcome|Control Group|"Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication.~Spinal anesthesia : spinal anesthesia~To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed."
163485|NCT01700517|O1|Outcome|Femoral Nerve Block|"In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine.~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block~To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed."
163486|NCT01700517|E3|Reported Event|Sciatic Nerves Block|"In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine.~sciatic nerves block : sciatic nerves block~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block"
163487|NCT01700517|E2|Reported Event|Control Group|"Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication.~Spinal anesthesia : spinal anesthesia"
163488|NCT01700517|E1|Reported Event|Femoral Nerve Block|"In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine.~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block"
163489|NCT01700439|B1|Baseline|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an Edwards INTUITY surgical aortic heart valve.
163490|NCT01700439|P1|Participant Flow|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an INTUITY study surgical aortic heart valve.
163491|NCT01700439|O1|Outcome|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an INTUITY study surgical aortic heart valve.
163492|NCT01700439|O1|Outcome|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an INTUITY study surgical aortic heart valve.
163493|NCT01700439|O1|Outcome|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an INTUITY study surgical aortic heart valve.
163494|NCT01700439|O1|Outcome|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an INTUITY study surgical aortic heart valve.
163495|NCT01700439|O1|Outcome|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an INTUITY study surgical aortic heart valve.
163496|NCT01700439|O1|Outcome|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an INTUITY study surgical aortic heart valve.
163497|NCT01700439|O1|Outcome|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an INTUITY study surgical aortic heart valve.
163498|NCT01700439|O1|Outcome|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an INTUITY study surgical aortic heart valve.
163499|NCT01700439|O1|Outcome|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an INTUITY study surgical aortic heart valve.
163500|NCT01700439|O1|Outcome|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an INTUITY study surgical aortic heart valve.
163501|NCT01700439|O1|Outcome|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an INTUITY study surgical aortic heart valve.
163502|NCT01700439|O1|Outcome|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an INTUITY study surgical aortic heart valve.
163503|NCT01700439|O1|Outcome|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an INTUITY study surgical aortic heart valve.
163504|NCT01700439|O1|Outcome|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an INTUITY study surgical aortic heart valve.
163505|NCT01700439|O1|Outcome|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an INTUITY study surgical aortic heart valve.
163506|NCT01700439|O1|Outcome|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an INTUITY study surgical aortic heart valve.
163507|NCT01700439|O1|Outcome|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an INTUITY study surgical aortic heart valve.
163508|NCT01700439|O1|Outcome|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an Edwards INTUITY surgical aortic heart valve.
163509|NCT01700439|O1|Outcome|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an Edwards INTUITY surgical aortic heart valve.
163510|NCT01700439|O1|Outcome|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an Edwards INTUITY surgical aortic heart valve.
163511|NCT01700439|E1|Reported Event|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an INTUITY study surgical aortic heart valve.
163512|NCT01700387|B3|Baseline|Total|Total of all reporting groups
163513|NCT01700387|B2|Baseline|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:~Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
163561|NCT01700192|E1|Reported Event|MK-8237 12 DU|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
183475|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
163514|NCT01700387|B1|Baseline|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:~Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
163515|NCT01700387|P2|Participant Flow|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:~Week 1: 1 tab qhs (every night at bedtime) Week 2: 1 tab bid (twice daily) Week 3: 1 tab q am (every day before noon) + 2 tabs qhs Week 4: 2 tabs bid~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
163516|NCT01700387|P1|Participant Flow|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:~Week 1: topiramate 25 mg qhs (every night at bedtime) Week 2: topiramate 25 mg bid (twice a day) Week 3: topiramate 25 mg q am (every day before noon) + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
163517|NCT01700387|O2|Outcome|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:~Week 1: 1 tab q hs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs q hs Week 4: 2 tabs bid~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
163518|NCT01700387|O1|Outcome|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:~Week 1: topiramate 25 mg q hs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50mg q hs Week 4: topiramate 50mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
163519|NCT01700387|O2|Outcome|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:~Week 1: 1 tab q hs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs q hs Week 4: 2 tabs bid~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
163520|NCT01700387|O1|Outcome|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:~Week 1: topiramate 25 mg q hs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50mg q hs Week 4: topiramate 50mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
163521|NCT01700387|O2|Outcome|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:~Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
163522|NCT01700387|O1|Outcome|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:~Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
163523|NCT01700387|E2|Reported Event|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:~Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
163562|NCT01700179|B1|Baseline|ACH-0143102 Plus Ribavirin|"ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. RBV (as per label) for Days 1-84.~ACH-0143102~Ribavirin"
183476|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
163524|NCT01700387|E1|Reported Event|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:~Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
163525|NCT01700348|B1|Baseline|All Randomized Subjects|The study was terminated early, data were not analyzed and the plaque samples were destroyed. Data cannot be provided for each arm separately, but only in aggregate.
163526|NCT01700348|P1|Participant Flow|All Enrolled Subjects|Airflosser & Manual Floss
163527|NCT01700348|O1|Outcome|All Randomized Subjects|"The study was terminated early, data were not analyzed and the plaque samples were destroyed."
163528|NCT01700348|E1|Reported Event|All Randomized Subjects|Summary of AEs for All Randomized Subjects
163529|NCT01700335|B1|Baseline|All Participants|All participants who received at least 1 dose of SyB L-1101 either at 1200 mg/day or 1800 mg/day intravenously.
163530|NCT01700335|P2|Participant Flow|SyB L-1101 1800 mg/Day Group|"Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
163531|NCT01700335|P1|Participant Flow|SyB L-1101 1200 mg/Day Group|"Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
163532|NCT01700335|O1|Outcome|All Participants|All participants who received at least 1 dose of SyB L-1101 either at 1200 mg/day or 1800 mg/day intravenously.
163533|NCT01700335|O2|Outcome|SyB L-1101 1800 mg/Day Group|"Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
163534|NCT01700335|O1|Outcome|SyB L-1101 1200 mg/Day Group|"Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
163535|NCT01700335|O2|Outcome|SyB L-1101 1800 mg/Day Group|"Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
163536|NCT01700335|O1|Outcome|SyB L-1101 1200 mg/Day Group|"Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
163537|NCT01700335|O2|Outcome|SyB L-1101 1800 mg/Day Group|"Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
163538|NCT01700335|O1|Outcome|SyB L-1101 1200 mg/Day Group|"Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
163539|NCT01700335|E2|Reported Event|SyB L-1101 1800 mg/Day Group|"Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
163540|NCT01700335|E1|Reported Event|SyB L-1101 1200 mg/Day Group|"Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
163541|NCT01700192|B3|Baseline|Total|Total of all reporting groups
163542|NCT01700192|B2|Baseline|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
163543|NCT01700192|B1|Baseline|MK-8237|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
163544|NCT01700192|P2|Participant Flow|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
163545|NCT01700192|P1|Participant Flow|MK-8237|Participants took MK-8237 12 development unit (DU) rapidly dissolving tablets administered sublingually once daily (q.d.) for up to one year.
163546|NCT01700192|O2|Outcome|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
163547|NCT01700192|O1|Outcome|MK-8237|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
163548|NCT01700192|O2|Outcome|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
163549|NCT01700192|O1|Outcome|MK-8237|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
163550|NCT01700192|O2|Outcome|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
163551|NCT01700192|O1|Outcome|MK-8237|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
163552|NCT01700192|O2|Outcome|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
163553|NCT01700192|O1|Outcome|MK-8237|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
163554|NCT01700192|O2|Outcome|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
163555|NCT01700192|O1|Outcome|MK-8237|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
183477|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
163563|NCT01700179|P1|Participant Flow|ACH-0143102 Plus Ribavirin|"ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. Weight-based RBV (as per the label) for Days 1-84.~ACH-0143102~Ribavirin"
163564|NCT01700179|O1|Outcome|ACH-0143102 Plus Ribavirin|"ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. Weight-based RBV (as per label) for Days 1-84.~ACH-0143102~Ribavirin"
163565|NCT01700179|E1|Reported Event|ACH-0143102 Plus Ribavirin|"ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. Weight-based RBV (as per label) for Days 1-84.~ACH-0143102~Ribavirin"
163566|NCT01700140|B4|Baseline|Total|Total of all reporting groups
163567|NCT01700140|B3|Baseline|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163568|NCT01700140|B2|Baseline|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163569|NCT01700140|B1|Baseline|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163570|NCT01700140|P3|Participant Flow|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163571|NCT01700140|P2|Participant Flow|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163572|NCT01700140|P1|Participant Flow|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163573|NCT01700140|O3|Outcome|SyB D-0701 25 cm2 Patch|SyB D-0701 25 cm2 patch (18.75 mg) was applied to subjects in low dose group and high dose group.
163574|NCT01700140|O2|Outcome|SyB D-0701 15 cm2 Patch|SyB D-0701 15 cm2 patch (11.25 mg) was applied to subjects in high dose group.
163575|NCT01700140|O1|Outcome|Placebo Patch|"Placebo 15 cm2 patch was applied to subjects in placebo group and low dose group.~Placebo 25 cm2 patch was applied to subjects in placebo group."
163576|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163577|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163578|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163579|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163580|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163581|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163582|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163583|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163584|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163585|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163586|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163587|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163588|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163589|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163590|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163591|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163592|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163593|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163594|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163595|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163596|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163597|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163598|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163599|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163600|NCT01700140|E3|Reported Event|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163601|NCT01700140|E2|Reported Event|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163602|NCT01700140|E1|Reported Event|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
163603|NCT01700036|B1|Baseline|Treatment Arm|"Alpha-1-Antitrypsin (AAT) for the treatment of Steroid Refractory Acute Graft vs Host Disease.~Alpha-1-Antitrypsin (AAT): AAT (Zemaira) will be administered at a dose of 60mg/kg (actual weight) on D1, 4, 8, 12, 16, 20, 24, and 28. A second course of treatment will not be given."
163604|NCT01700036|P1|Participant Flow|Treatment Arm|"Alpha-1-Antitrypsin (AAT) for the treatment of Steroid Refractory Acute Graft vs Host Disease.~Alpha-1-Antitrypsin (AAT): AAT (Zemaira) will be administered at a dose of 60mg/kg (actual weight) on D1, 4, 8, 12, 16, 20, 24, and 28. A second course of treatment will not be given."
163605|NCT01700036|O1|Outcome|Treatment Arm|Alpha-1-Antitrypsin (AAT): AAT (Zemaira) will be administered at a dose of 60mg/kg (actual weight) on D1, 4, 8, 12, 16, 20, 24, and 28.
164479|NCT01696643|O1|Outcome|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
163606|NCT01700036|O1|Outcome|Treatment Arm|Alpha-1-Antitrypsin (AAT): AAT (Zemaira) will be administered at a dose of 60mg/kg (actual weight) on D1, 4, 8, 12, 16, 20, 24, and 28.
163607|NCT01700036|O1|Outcome|Treatment Arm|Alpha-1-Antitrypsin (AAT): AAT (Zemaira) will be administered at a dose of 60mg/kg (actual weight) on D1, 4, 8, 12, 16, 20, 24, and 28.
163608|NCT01700036|O1|Outcome|Treatment Arm|Alpha-1-Antitrypsin (AAT): AAT (Zemaira) will be administered at a dose of 60mg/kg (actual weight) on D1, 4, 8, 12, 16, 20, 24, and 28.
163609|NCT01700036|O1|Outcome|Treatment Arm|Alpha-1-Antitrypsin (AAT): AAT (Zemaira) will be administered at a dose of 60mg/kg (actual weight) on D1, 4, 8, 12, 16, 20, 24, and 28.
163610|NCT01700036|O1|Outcome|Treatment Arm|Alpha-1-Antitrypsin (AAT): AAT (Zemaira) will be administered at a dose of 60mg/kg (actual weight) on D1, 4, 8, 12, 16, 20, 24, and 28.
163611|NCT01700036|E1|Reported Event|Treatment Arm|Alpha-1-Antitrypsin (AAT): AAT (Zemaira) will be administered at a dose of 60mg/kg (actual weight) on D1, 4, 8, 12, 16, 20, 24, and 28.
163612|NCT01699867|B1|Baseline|Optical Coherence Tomography (Single-arm)|Specimens from all patients were evaluated by optical coherence tomography.
163613|NCT01699867|P1|Participant Flow|Optical Coherence Tomography (Single-arm)|Specimens from all patients were evaluated by optical coherence tomography.
163614|NCT01699867|O1|Outcome|Optical Coherence Tomography (Single-arm)|Specimens from all patients were evaluated by optical coherence tomography.
163615|NCT01699867|O1|Outcome|Optical Coherence Tomography (Single-arm)|Specimens from all patients were evaluated by optical coherence tomography.
163616|NCT01699867|E1|Reported Event|All Patients (Single-arm)|All enrolled study patients.
163617|NCT01699815|B3|Baseline|Total|Total of all reporting groups
163618|NCT01699815|B2|Baseline|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.~Acetaminophen"
163619|NCT01699815|B1|Baseline|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.~Acetaminophen"
163620|NCT01699815|P2|Participant Flow|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.~Acetaminophen"
163621|NCT01699815|P1|Participant Flow|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.~Acetaminophen"
163622|NCT01699815|O2|Outcome|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.~Acetaminophen"
163623|NCT01699815|O1|Outcome|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.~Acetaminophen"
163624|NCT01699815|O2|Outcome|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.~Acetaminophen"
163625|NCT01699815|O1|Outcome|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.~Acetaminophen"
163626|NCT01699815|O2|Outcome|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.~Acetaminophen"
163627|NCT01699815|O1|Outcome|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.~Acetaminophen"
163628|NCT01699815|E2|Reported Event|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.~Acetaminophen"
163629|NCT01699815|E1|Reported Event|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended for OfirmevTM administration.~Acetaminophen"
163630|NCT01699789|B3|Baseline|Total|Total of all reporting groups
163631|NCT01699789|B2|Baseline|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163696|NCT01699763|P1|Participant Flow|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
163697|NCT01699763|O1|Outcome|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
163723|NCT01699750|O1|Outcome|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
163632|NCT01699789|B1|Baseline|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163633|NCT01699789|P2|Participant Flow|Community Engagement and Planning CEP|"The CEP arm supported 4 months of planning for the CEP Council consisting of representatives from all assigned programs in biweekly 2 hour meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites were provided with enrolled client lists.~QI Program: The QI program is an evidence-based toolkit from prior studies that supported team leadership, case and care management, medication management, and CBT for Depression. The Case management manual supported depression screening and monitoring/tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual.~CEP Council: The CEP Council was supported by a workbook de"
163634|NCT01699789|P1|Participant Flow|Resources for Services RS|"The RS condition offers time-limited technical assistance to individual agencies, coupled with outreach from a community engagement specialty, to participate in structured reviews of components of the Quality Improvement (QI) Program Intervention as implemented by the RS Expert Team.~QI Program: The quality improvement program is an evidence-based toolkit from prior studies that supported team leadership, case and care management, medication management, and CBT for Depression. The Case management manual supported depression screening and monitoring/tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual.~RS Expert Team: The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a quality improvement expert, and staff support. T"
163635|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163636|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163637|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163638|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163698|NCT01699763|O1|Outcome|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
163724|NCT01699750|E2|Reported Event|ACUVUE OASYS With HYDRACLEAR|Senofilcon A contact lenses worn for 60 days, replaced biweekly
163639|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163640|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163641|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163642|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163643|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163644|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163645|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163699|NCT01699763|O1|Outcome|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
183478|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
163646|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163647|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163648|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163649|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163650|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163651|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163652|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163700|NCT01699763|E1|Reported Event|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
163701|NCT01699750|B3|Baseline|Total|Total of all reporting groups
163653|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163654|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163655|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163656|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163657|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163658|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163659|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163702|NCT01699750|B2|Baseline|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
163703|NCT01699750|B1|Baseline|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
163704|NCT01699750|P2|Participant Flow|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
163862|NCT01698684|O1|Outcome|Placebo|Placebo: One dose 15 minutes before attempting intercourse
163660|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163661|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163662|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163663|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163664|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163665|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163666|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163705|NCT01699750|P1|Participant Flow|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
163706|NCT01699750|O2|Outcome|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
163707|NCT01699750|O1|Outcome|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
163708|NCT01699750|O2|Outcome|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
163667|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163668|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163669|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163670|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163671|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163672|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163673|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163709|NCT01699750|O1|Outcome|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
163710|NCT01699750|O4|Outcome|BIOTRUE With Acuvue Oasys|BIOTRUE with senofilcon A contact lenses for 30 days
163711|NCT01699750|O3|Outcome|BIOTRUE With Air Optix Aqua|BIOTRUE with lotrafilcon B contact lenses for 30 days
163712|NCT01699750|O2|Outcome|OFPM With Acuvue Oasys|OFPM with senofilcon A contact lenses for 30 days
163674|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163675|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163676|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163677|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163678|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163679|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163680|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163713|NCT01699750|O1|Outcome|OFPM With Air Optix Aqua|OFPM with lotrafilcon B contact lenses for 30 days
163714|NCT01699750|O4|Outcome|BIOTRUE With Acuvue Oasys|BIOTRUE with senofilcon A contact lenses for 30 days
163715|NCT01699750|O3|Outcome|BIOTRUE With Air Optix Aqua|BIOTRUE with lotrafilcon B contact lenses for 30 days
163716|NCT01699750|O2|Outcome|OFPM With Acuvue Oasys|OFPM with senofilcon A contact lenses for 30 days
163681|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163682|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163683|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163684|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163685|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163686|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163687|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163717|NCT01699750|O1|Outcome|OFPM With Air Optix Aqua|OFPM with lotrafilcon B contact lenses for 30 days
163718|NCT01699750|O2|Outcome|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
163719|NCT01699750|O1|Outcome|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
163720|NCT01699750|O2|Outcome|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
163688|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163689|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163690|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163691|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163692|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163693|NCT01699789|E2|Reported Event|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
163694|NCT01699789|E1|Reported Event|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
163695|NCT01699763|B1|Baseline|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
164480|NCT01696643|E2|Reported Event|Placebo|Placebo, administered orally, BID for 52 weeks
163725|NCT01699750|E1|Reported Event|AIR OPTIX AQUA|Lotrafilcon B contact lenses worn for 60 days, replaced monthly
163726|NCT01699698|B3|Baseline|Total|Total of all reporting groups
163727|NCT01699698|B2|Baseline|Control|Normal cohort
163728|NCT01699698|B1|Baseline|Test Subject|UICC Stage II pancreatic ductal adenocarcinoma cohort
163729|NCT01699698|P2|Participant Flow|Control|Normal cohort
163730|NCT01699698|P1|Participant Flow|Test Subject|UICC StageII pancreatic ductal adenocarcinoma cohort
163731|NCT01699698|O2|Outcome|Control|Normal cohort
163732|NCT01699698|O1|Outcome|Test Subject|UICC StageII pancreatic ductal adenocarcinoma cohort
163733|NCT01699698|O2|Outcome|Control|Normal cohort
163734|NCT01699698|O1|Outcome|Test Subject|UICC Stage II pancreatic ductal adenocarcinoma cohort
163735|NCT01699698|E2|Reported Event|Normal|Normal cohort
163736|NCT01699698|E1|Reported Event|Test Subject|UICC StageII pancreatic ductal adenocarcinoma cohort
163737|NCT01699685|B3|Baseline|Total|Total of all reporting groups
163738|NCT01699685|B2|Baseline|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
163739|NCT01699685|B1|Baseline|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
163740|NCT01699685|P2|Participant Flow|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
163741|NCT01699685|P1|Participant Flow|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
163742|NCT01699685|O2|Outcome|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
163743|NCT01699685|O1|Outcome|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
163744|NCT01699685|O2|Outcome|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
163745|NCT01699685|O1|Outcome|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
163746|NCT01699685|O2|Outcome|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
163747|NCT01699685|O1|Outcome|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
163748|NCT01699685|O2|Outcome|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
163749|NCT01699685|O1|Outcome|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
163750|NCT01699685|O2|Outcome|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
163751|NCT01699685|O1|Outcome|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
163752|NCT01699685|O2|Outcome|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
163753|NCT01699685|O1|Outcome|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
163754|NCT01699685|E2|Reported Event|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
163755|NCT01699685|E1|Reported Event|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
163756|NCT01699607|B3|Baseline|Total|Total of all reporting groups
163757|NCT01699607|B2|Baseline|Nonsmoker Subjects|Nonsmokers are subjects who smoked 40 cigarettes or less in their lifetime, and none within the past year.
163758|NCT01699607|B1|Baseline|Cigarette Smokers|Cigarette smokers are subjects who smoke 10 or more cigarettes per day in the past year.
163759|NCT01699607|P2|Participant Flow|Nonsmoking Subjects|Nonsmokers are subjects who have smoked less than 40 cigarettes in their lifetime, and none within the last year. All subjects will receive amphetamine at 0.5 kg/mg to induce elevated dopamine levels in the brain. This dosage of amphetamine is given by mouth about 150 minutes prior to the second PET scan.
163760|NCT01699607|P1|Participant Flow|Cigarette Smokers|Cigarette smokers are subjects who smoke 10 or more cigarettes per day for the past year. All subjects will receive amphetamine at 0.5 kg/mg to induce elevated dopamine levels in the brain. This dosage of amphetamine is given by mouth about 150 minutes prior to the second PET scan.
163761|NCT01699607|O2|Outcome|Nonsmoking Subjects|Nonsmokers. These are subjects who smoked less than 40 cigarettes in their lifetime and none in the last year. All subjects will receive amphetamine to induce elevated dopamine levels in the brain at a dose of 0.5mg/kg. They will all receive the amphetamine prior to the second PET scan
163762|NCT01699607|O1|Outcome|Smoking Subjects|Cigarette smokers. These are subjects who smoke at least 10 cigarettes per day for the last year. All subjects will receive amphetamine to induce elevated dopamine levels in the brain at a dose of 0.5mg/kg. They will all receive the amphetamine prior to the second PET scan.
163763|NCT01699607|E1|Reported Event|Amphetamine|"There is only one arm to the study. All subjects will receive amphetamine.~Amphetamine: All subjects will receive amphetamine to induce elevated dopamine levels in the brain."
163764|NCT01699373|B3|Baseline|Total|Total of all reporting groups
163765|NCT01699373|B2|Baseline|Manual Palpation|
163766|NCT01699373|B1|Baseline|Ultrasound-assisted|Pre-procedural ultrasound scan performed
163767|NCT01699373|P2|Participant Flow|Manual Palpation|
163768|NCT01699373|P1|Participant Flow|Ultrasound-assisted|Pre-procedural ultrasound scan performed
163769|NCT01699373|O2|Outcome|Manual Palpation|
163770|NCT01699373|O1|Outcome|Ultrasound-assisted|Pre-procedural ultrasound scan performed
163771|NCT01699373|E2|Reported Event|Manual Palpation|
163772|NCT01699373|E1|Reported Event|Ultrasound-assisted|Pre-procedural ultrasound scan performed
163773|NCT01699087|B1|Baseline|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
163774|NCT01699087|P1|Participant Flow|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
163775|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
163863|NCT01698684|E3|Reported Event|Avanafil 200 mg|Avanafil 200 mg: One dose 15 minutes before attempting intercourse
163776|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
163777|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
163778|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
163779|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
163780|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
163781|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
163782|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
163783|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
163784|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
163785|NCT01699087|E2|Reported Event|PRK ALLEGRETTO|All subjects who underwent PRK surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
163786|NCT01699087|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to the initiation of study treatment
163787|NCT01699022|B1|Baseline|Injection Cyclofem|"Injection of Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials.~Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection."
163788|NCT01699022|P1|Participant Flow|Injection Cyclofem|"Injection of Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials.~Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection."
163789|NCT01699022|O1|Outcome|Cyclofem|
163790|NCT01699022|O1|Outcome|Cyclofem|
163791|NCT01699022|O1|Outcome|Cyclofem|
163792|NCT01699022|O1|Outcome|Injection Cyclofem|"Injection of Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials.~Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection."
163793|NCT01699022|O1|Outcome|Cyclofem|
163794|NCT01699022|O1|Outcome|Cyclofem|
163795|NCT01699022|O1|Outcome|Cyclofem|
163796|NCT01699022|O1|Outcome|Cyclofem|
163797|NCT01699022|O1|Outcome|Cyclofem|
163798|NCT01699022|O1|Outcome|Injection Cyclofem|"Injection of Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials.~Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection."
163799|NCT01699022|E1|Reported Event|Injection Cyclofem|"Injection of Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials.~Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection."
163800|NCT01698814|B3|Baseline|Total|Total of all reporting groups
163801|NCT01698814|B2|Baseline|AL-4943A Vehicle|AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
163802|NCT01698814|B1|Baseline|AL-4943A|AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks
163803|NCT01698814|P2|Participant Flow|AL-4943A Vehicle|AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
163804|NCT01698814|P1|Participant Flow|AL-4943A|AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks
163805|NCT01698814|O2|Outcome|AL-4943A Vehicle|AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
163806|NCT01698814|O1|Outcome|AL-4943A|AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks
163807|NCT01698814|E2|Reported Event|AL-4943A Vehicle|AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
163808|NCT01698814|E1|Reported Event|AL-4943A|AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks
163809|NCT01698801|B1|Baseline|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
163810|NCT01698801|P1|Participant Flow|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
163811|NCT01698801|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
163812|NCT01698801|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
163813|NCT01698801|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
163814|NCT01698801|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
163815|NCT01698801|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
163816|NCT01698801|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason."
163817|NCT01698801|E1|Reported Event|Lenalidomide Plus Dexamethasone|"Lenalidomide: 25 mg oral lenalidomide once daily on Days 1 through 21 of each 28-day cycle~Dexamethasone: 40 mg oral dexamethasone once daily on Days 1, 8, 15 and 22 of each 28-day cycle"
163818|NCT01698775|B3|Baseline|Total|Total of all reporting groups
163819|NCT01698775|B2|Baseline|Placebo to Omarigliptin (Phase A)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
163820|NCT01698775|B1|Baseline|Omarigliptin (Phase A)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
163821|NCT01698775|P2|Participant Flow|Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
163822|NCT01698775|P1|Participant Flow|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
163823|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
163824|NCT01698775|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
163825|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
163826|NCT01698775|O1|Outcome|Omarigliptin (Phase A)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
163827|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
163828|NCT01698775|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
163829|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
163830|NCT01698775|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
163831|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
163832|NCT01698775|O1|Outcome|Omarigliptin (Phase A)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
163864|NCT01698684|E2|Reported Event|Avanafil 100 mg|Avanafil 100 mg: One dose 15 minutes before attempting intercourse
163865|NCT01698684|E1|Reported Event|Placebo|Placebo: One dose 15 minutes before attempting intercourse
163866|NCT01698554|B5|Baseline|Total|Total of all reporting groups
163833|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
163834|NCT01698775|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
163835|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
163836|NCT01698775|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
163837|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
163838|NCT01698775|O1|Outcome|Omarigliptin (Phase A)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
163839|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
163840|NCT01698775|O1|Outcome|Omarigliptin (Phase A)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
163841|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
163842|NCT01698775|O1|Outcome|Omarigliptin (Phase A)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
163843|NCT01698775|E4|Reported Event|Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
163844|NCT01698775|E3|Reported Event|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
163845|NCT01698775|E2|Reported Event|Placebo to Omarigliptin (Phase A)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
163846|NCT01698775|E1|Reported Event|Omarigliptin (Phase A)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
163847|NCT01698710|B1|Baseline|Albumin Bound Paclitaxel|"Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.~Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure."
163848|NCT01698710|P1|Participant Flow|Albumin Bound Paclitaxel|"Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.~Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure."
163849|NCT01698710|O1|Outcome|Albumin Bound Paclitaxel|"Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.~Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure."
163850|NCT01698710|O1|Outcome|Albumin Bound Paclitaxel|"Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.~Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure."
163851|NCT01698710|O1|Outcome|Albumin Bound Paclitaxel|"Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.~Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure."
163852|NCT01698710|E1|Reported Event|Albumin Bound Paclitaxel|"Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.~Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure."
163853|NCT01698684|B4|Baseline|Total|Total of all reporting groups
163854|NCT01698684|B3|Baseline|Avanafil 200 mg|Avanafil 200 mg: One dose 15 minutes before attempting intercourse
163855|NCT01698684|B2|Baseline|Avanafil 100 mg|Avanafil 100 mg: One dose 15 minutes before attempting intercourse
163856|NCT01698684|B1|Baseline|Placebo|Placebo: One dose 15 minutes before attempting intercourse
163857|NCT01698684|P3|Participant Flow|Avanafil 200 mg|Avanafil 200 mg: One dose 15 minutes before attempting intercourse
163858|NCT01698684|P2|Participant Flow|Avanafil 100 mg|Avanafil 100 mg: One dose 15 minutes before attempting intercourse
163859|NCT01698684|P1|Participant Flow|Placebo|Placebo: One dose 15 minutes before attempting intercourse
163860|NCT01698684|O3|Outcome|Avanafil 200 mg|Avanafil 200 mg: One dose 15 minutes before attempting intercourse
163861|NCT01698684|O2|Outcome|Avanafil 100 mg|Avanafil 100 mg: One dose 15 minutes before attempting intercourse
163867|NCT01698554|B4|Baseline|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163868|NCT01698554|B3|Baseline|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163869|NCT01698554|B2|Baseline|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163870|NCT01698554|B1|Baseline|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163871|NCT01698554|P4|Participant Flow|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163872|NCT01698554|P3|Participant Flow|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163873|NCT01698554|P2|Participant Flow|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163874|NCT01698554|P1|Participant Flow|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163875|NCT01698554|O4|Outcome|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163876|NCT01698554|O3|Outcome|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163877|NCT01698554|O2|Outcome|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163878|NCT01698554|O1|Outcome|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163879|NCT01698554|O4|Outcome|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163880|NCT01698554|O3|Outcome|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163881|NCT01698554|O2|Outcome|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163882|NCT01698554|O1|Outcome|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163883|NCT01698554|O4|Outcome|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163884|NCT01698554|O3|Outcome|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163885|NCT01698554|O2|Outcome|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163886|NCT01698554|O1|Outcome|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163887|NCT01698554|O4|Outcome|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163888|NCT01698554|O3|Outcome|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163889|NCT01698554|O2|Outcome|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163890|NCT01698554|O1|Outcome|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163891|NCT01698554|O4|Outcome|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163892|NCT01698554|O3|Outcome|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163893|NCT01698554|O2|Outcome|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163894|NCT01698554|O1|Outcome|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163895|NCT01698554|E4|Reported Event|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163896|NCT01698554|E3|Reported Event|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163897|NCT01698554|E2|Reported Event|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163898|NCT01698554|E1|Reported Event|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
163900|NCT01698528|B2|Baseline|Control Group|The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
163901|NCT01698528|B1|Baseline|Intervention Group|"The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.~Tablet Computer"
163902|NCT01698528|P2|Participant Flow|Control Group|The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
163903|NCT01698528|P1|Participant Flow|Intervention Group|"The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.~Tablet Computer"
163904|NCT01698528|O2|Outcome|Control Group|The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
163905|NCT01698528|O1|Outcome|Intervention Group|"The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.~Tablet Computer"
163906|NCT01698528|O2|Outcome|Control Group|The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
163907|NCT01698528|O1|Outcome|Intervention Group|"The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.~Tablet Computer"
163908|NCT01698528|O2|Outcome|Control Group|The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
163909|NCT01698528|O1|Outcome|Intervention Group|"The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.~Tablet Computer"
163910|NCT01698528|O2|Outcome|Control Group|The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
163911|NCT01698528|O1|Outcome|Intervention Group|"The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.~Tablet Computer"
163912|NCT01698528|O2|Outcome|Control Group|The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
163913|NCT01698528|O1|Outcome|Intervention Group|"The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.~Tablet Computer"
163914|NCT01698528|E2|Reported Event|Control Group|The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
163915|NCT01698528|E1|Reported Event|Intervention Group|"The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.~Tablet Computer"
163916|NCT01698502|B3|Baseline|Total|Total of all reporting groups
163917|NCT01698502|B2|Baseline|Untrained|Healthy, sedentary (Maximal oxygen uptake (VO2max), ml*min-1*kg-1<50), 20-30 year, BMI: 18,5-25kg/m2, males.
163918|NCT01698502|B1|Baseline|Trained|Healthy, Endurance trained (Maximal oxygen uptake (VO2max), ml*min-1*kg-1>60), 20-30 year, BMI: 18,5-25kg/m2, males.
163919|NCT01698502|P2|Participant Flow|Untrained|Healthy, sedentary (VO2max, ml*min-1*kg-1<50), 20-30 year, BMI: 18,5-25kg/m2, males.
163920|NCT01698502|P1|Participant Flow|Trained|Healthy, Endurance trained (VO2max, ml*min-1*kg-1>60), 20-30 year, BMI: 18,5-25kg/m2, males.
163921|NCT01698502|O2|Outcome|Untrained|Healthy, sedentary (VO2max, ml*min-1*kg-1<50), 20-30 year, BMI: 18,5-25kg/m2, males.
163922|NCT01698502|O1|Outcome|Trained|Healthy, Endurance trained (VO2max, ml*min-1*kg-1>60), 20-30 year, BMI: 18,5-25kg/m2, males.
163923|NCT01698502|O2|Outcome|Untrained|Healthy, sedentary (VO2max, ml*min-1*kg-1<50), 20-30 year, BMI: 18,5-25kg/m2, males.
163924|NCT01698502|O1|Outcome|Trained|Healthy, Endurance trained (VO2max, ml*min-1*kg-1>60), 20-30 year, BMI: 18,5-25kg/m2, males.
163925|NCT01698502|E2|Reported Event|Untrained|Healthy, sedentary (VO2max, ml*min-1*kg-1<50), 20-30 year, BMI: 18,5-25kg/m2, males.
163926|NCT01698502|E1|Reported Event|Trained|Healthy, Endurance trained (VO2max, ml*min-1*kg-1>60), 20-30 year, BMI: 18,5-25kg/m2, males.
163927|NCT01698320|B3|Baseline|Total|Total of all reporting groups
163928|NCT01698320|B2|Baseline|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
163929|NCT01698320|B1|Baseline|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
163930|NCT01698320|P3|Participant Flow|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
163931|NCT01698320|P2|Participant Flow|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
163932|NCT01698320|P1|Participant Flow|All Enrolled Subjects|Includes subjects who were enrolled in study and participated in the single-blind (subjects were blinded) run-in period in which subjects used the inhaler with placebo and maintained the diary for about one week prior to randomization and starting the 12-week double-blind period.
163933|NCT01698320|O2|Outcome|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
163934|NCT01698320|O1|Outcome|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
163935|NCT01698320|O2|Outcome|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
163936|NCT01698320|O1|Outcome|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
163937|NCT01698320|O2|Outcome|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
163938|NCT01698320|O1|Outcome|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
164267|NCT01697501|E1|Reported Event|Chronic Hepatitis B Patients|Interleukin 28B testing: Blood sampling for IL28B genotyping
163939|NCT01698320|O2|Outcome|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
163940|NCT01698320|O1|Outcome|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
163941|NCT01698320|O2|Outcome|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
163942|NCT01698320|O1|Outcome|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
163943|NCT01698320|O2|Outcome|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
163944|NCT01698320|O1|Outcome|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
163945|NCT01698320|E4|Reported Event|Albuterol MDPI (Formerly Albuterol) - Open Label Period|After completing 12 weeks of albuterol QID treatment, participants continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg/inhalation as required (PRN).
163946|NCT01698320|E3|Reported Event|Albuterol MDPI (Formerly Placebo) - Open Label Period|After completing 12 weeks of placebo QID treatment, participants continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg/inhalation as required (PRN).
163947|NCT01698320|E2|Reported Event|Placebo MDPI - Double-blind Period|Placebo delivered using a multi-dose dry powder inhaler (MDPI or Spiromax) as 2 inhalations four times a day for the 12 week double-blind period.
163948|NCT01698320|E1|Reported Event|Albuterol MDPI - Double-blind Period|Albuterol multi-dose dry powder inhaler (MDPI or Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period.
163949|NCT01698268|B3|Baseline|Total|Total of all reporting groups
163950|NCT01698268|B2|Baseline|Local Infiltration Group|"Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.~Local Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon."
163951|NCT01698268|B1|Baseline|TAP Group|"Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.~TAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist."
163952|NCT01698268|P2|Participant Flow|Local Infiltration Group|"Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.~Local Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon."
163953|NCT01698268|P1|Participant Flow|TAP Group|"Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.~TAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist."
163954|NCT01698268|O2|Outcome|Local Infiltration Group|"Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.~Local Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon."
163955|NCT01698268|O1|Outcome|TAP Group|"Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.~TAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist."
163956|NCT01698268|E2|Reported Event|Local Infiltration Group|"Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.~Local Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon."
163957|NCT01698268|E1|Reported Event|TAP Group|"Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.~TAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist."
163958|NCT01697969|B1|Baseline|Overall Study|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
163959|NCT01697969|P1|Participant Flow|Overall Study|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
163960|NCT01697969|O2|Outcome|Right Eye|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily for 14 days
163961|NCT01697969|O1|Outcome|Left Eye|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily for 14 days
163962|NCT01697969|E1|Reported Event|Overall Study|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
163964|NCT01697956|B2|Baseline|Placebo Nasal Aerosol|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
163965|NCT01697956|B1|Baseline|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
163966|NCT01697956|P2|Participant Flow|Placebo Nasal Aerosol|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
163967|NCT01697956|P1|Participant Flow|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
163968|NCT01697956|O4|Outcome|Placebo Nasal Aerosol - Shift to Low|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
163969|NCT01697956|O3|Outcome|Placebo Nasal Aerosol - Shift to High|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
163970|NCT01697956|O2|Outcome|BDP Nasal Aerosol 80 mcg/Day - Shift to Low|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
163971|NCT01697956|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day - Shift to High|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
163972|NCT01697956|O4|Outcome|Placebo Nasal Aerosol - Shift to Low|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
163973|NCT01697956|O3|Outcome|Placebo Nasal Aerosol - Shift to High|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
163974|NCT01697956|O2|Outcome|BDP Nasal Aerosol 80 mcg/Day - Shift to Low|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
163975|NCT01697956|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day - Shift to High|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
163976|NCT01697956|O2|Outcome|Placebo Nasal Aerosol|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
163977|NCT01697956|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
163978|NCT01697956|O2|Outcome|BDP Pharmacokinetic Parameters|PK values characterizing beclomethasone dipropionate (BDP)
163979|NCT01697956|O1|Outcome|17-BMP Pharmacokinetic Parameters|PK values characterizing the active metabolite for BDP
163980|NCT01697956|O2|Outcome|BDP Pharmacokinetic Parameters|PK values characterizing beclomethasone dipropionate (BDP)
163981|NCT01697956|O1|Outcome|17-BMP Pharmacokinetic Parameters|PK values characterizing the active metabolite for BDP
163982|NCT01697956|O2|Outcome|BDP Pharmacokinetic Parameters|PK values characterizing beclomethasone dipropionate (BDP)
163983|NCT01697956|O1|Outcome|17-BMP Pharmacokinetic Parameters|PK values characterizing the active metabolite for BDP
163984|NCT01697956|O2|Outcome|BDP Pharmacokinetic Parameters|PK values characterizing beclomethasone dipropionate (BDP)
163985|NCT01697956|O1|Outcome|17-BMP Pharmacokinetic Parameters|PK values characterizing the active metabolite for BDP
163986|NCT01697956|O2|Outcome|BDP Pharmacokinetic Parameters|PK values characterizing beclomethasone dipropionate (BDP)
163987|NCT01697956|O1|Outcome|17-BMP Pharmacokinetic Parameters|PK values characterizing the active metabolite for BDP
163988|NCT01697956|O2|Outcome|BDP Pharmacokinetic Parameters|PK values characterizing beclomethasone dipropionate (BDP)
163989|NCT01697956|O1|Outcome|17-BMP Pharmacokinetic Parameters|PK values characterizing the active metabolite for BDP
163990|NCT01697956|O2|Outcome|Placebo Nasal Aerosol|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
163991|NCT01697956|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
163992|NCT01697956|E2|Reported Event|Placebo Nasal Aerosol|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
163993|NCT01697956|E1|Reported Event|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
163994|NCT01697696|B3|Baseline|Total|Total of all reporting groups
163995|NCT01697696|B2|Baseline|QAB149|75 μg once-daily
163996|NCT01697696|B1|Baseline|NVA237|12.5 μg twice-daily
163997|NCT01697696|P2|Participant Flow|QAB149|75 μg once-daily
163998|NCT01697696|P1|Participant Flow|NVA237|12.5 μg twice-daily
163999|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
164000|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
164001|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
164002|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
164003|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
164004|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
164005|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
164006|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
164007|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
164008|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
164009|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
164010|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
164011|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
164012|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
164013|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
164020|NCT01697592|B10|Baseline|Placebo/α-GI (Phase A) Switching to Omari. 25 mg/α-GI (Ph. B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
164021|NCT01697592|B9|Baseline|Placebo/TZD (Phase A) Switching to Omari. 25 mg/TZD (Phase B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZD throughout the duration of the study.
164022|NCT01697592|B8|Baseline|Placebo/BG (Phase A) Switching to Omari. 25 mg/BG (Phase B)|Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BG throughout the duration of the study.
164023|NCT01697592|B7|Baseline|Placebo/Gln (Phase A) Switching to Omari. 25 mg/Gln (Ph. B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of Gln throughout the duration of the study.
164024|NCT01697592|B6|Baseline|Placebo/SU (Phase A) Switching to Omari. 25 mg/SU (Phase B)|Placebo to omarigliptin (omari.)administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SU throughout the duration of the study.
164025|NCT01697592|B5|Baseline|Omarigliptin 25 mg/α-GI (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.
164026|NCT01697592|B4|Baseline|Omarigliptin 25 mg/TZD (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
164027|NCT01697592|B3|Baseline|Omarigliptin 25 mg/BG (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
164028|NCT01697592|B2|Baseline|Omarigliptin 25 mg/Gln (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.
164029|NCT01697592|B1|Baseline|Omarigliptin 25 mg/SU (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
164030|NCT01697592|P10|Participant Flow|Placebo/α-GI (Phase A) Switching to Omari. 25 mg/α-GI (Ph. B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
164031|NCT01697592|P9|Participant Flow|Placebo/TZD (Phase A) Switching to Omari. 25 mg/TZ (Phase B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZD throughout the duration of the study.
164032|NCT01697592|P8|Participant Flow|Placebo/BG (Phase A) Switching to Omari. 25 mg/BG (Phase B)|Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BG. throughout the duration of the study.
164033|NCT01697592|P7|Participant Flow|Placebo/Gln. (Phase A) Switching to Omari. 25 mg/Gln (Phase B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of Gln throughout the duration of the study.
164034|NCT01697592|P6|Participant Flow|Placebo/SU (Phase A) Switching to Omari. 25 mg/SU (Phase B)|Placebo to omarigliptin (omari.)administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SU throughout the duration of the study.
164035|NCT01697592|P5|Participant Flow|Omarigliptin 25 mg/α-GI (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-glucosidase (α-GI) throughout the duration of the study.
164036|NCT01697592|P4|Participant Flow|Omarigliptin 25 mg/Thiazolidinediones (TZD) (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
164037|NCT01697592|P3|Participant Flow|Omarigliptin 25 mg/Biguanides (BG) (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
164038|NCT01697592|P2|Participant Flow|Omarigliptin 25 mg/Glinides (Gln) (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.
164039|NCT01697592|P1|Participant Flow|Omarigliptin 25 mg/Sulfonylureas (SU) (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
164040|NCT01697592|O10|Outcome|Placebo/α-GI (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
164041|NCT01697592|O9|Outcome|Placebo/TZD (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
164042|NCT01697592|O8|Outcome|Placebo/BG (Phase A)|Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
164468|NCT01696643|P1|Participant Flow|CB-5945|0.25 milligrams (mg) CB-5945, administered orally, twice daily (BID) for 52 weeks
164043|NCT01697592|O7|Outcome|Placebo/Gln. (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln. throughout the duration of the study.
164044|NCT01697592|O6|Outcome|Placebo/SU (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
164045|NCT01697592|O5|Outcome|Omarigliptin 25 mg/α-GI (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
164046|NCT01697592|O4|Outcome|Omarigliptin 25 mg/TZD (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
164047|NCT01697592|O3|Outcome|Omarigliptin 25 mg/BG (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
164048|NCT01697592|O2|Outcome|Omarigliptin 25 mg/Gln (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
164049|NCT01697592|O1|Outcome|Omarigliptin 25 mg/SU (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
164050|NCT01697592|O10|Outcome|Omarigliptin 25mg/α-GI (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
164051|NCT01697592|O9|Outcome|Omarigliptin 25mg/TZD (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of TZD throughout the duration of the study.
164052|NCT01697592|O8|Outcome|Omarigliptin 25mg/BG (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of BG. throughout the duration of the study.
164053|NCT01697592|O7|Outcome|Omarigliptin 25mg/Gln (Phase B)|"Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.~Participants continued pre-study basal medication of Gln throughout the duration of the study."
164054|NCT01697592|O6|Outcome|Omarigliptin 25mg/SU (Phase B)|"Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.~Participants continued prestudy basal medication of SU throughout the duration of the study."
164055|NCT01697592|O5|Outcome|Omarigliptin 25 mg/α-GI (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.
164056|NCT01697592|O4|Outcome|Omarigliptin 25 mg/TZD (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
164057|NCT01697592|O3|Outcome|Omarigliptin 25 mg/BG (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
164058|NCT01697592|O2|Outcome|Omarigliptin 25 mg/Gln (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
164059|NCT01697592|O1|Outcome|Omarigliptin 25 mg/SU (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
164060|NCT01697592|O10|Outcome|Placebo/α-GI (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
164061|NCT01697592|O9|Outcome|Placebo/TZD (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
164062|NCT01697592|O8|Outcome|Placebo/BG (Phase A)|Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
164063|NCT01697592|O7|Outcome|Placebo/Gln. (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
164064|NCT01697592|O6|Outcome|Placebo/SU (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
164065|NCT01697592|O5|Outcome|Omarigliptin 25 mg/α-GI (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
164066|NCT01697592|O4|Outcome|Omarigliptin 25 mg/TZD (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
164067|NCT01697592|O3|Outcome|Omarigliptin 25 mg/BG (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
164068|NCT01697592|O2|Outcome|Omarigliptin 25 mg/Gln (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
164069|NCT01697592|O1|Outcome|Omarigliptin 25 mg/SU (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
164070|NCT01697592|O10|Outcome|Omarigliptin 25mg/α-GI (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
164071|NCT01697592|O9|Outcome|Omarigliptin 25mg/TZD (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of TZD throughout the duration of the study.
164072|NCT01697592|O8|Outcome|Omarigliptin 25mg/BG (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of BG throughout the duration of the study.
164073|NCT01697592|O7|Outcome|Omarigliptin 25mg/Gln (Phase B)|"Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.~Participants continued pre-study basal medication of Gln throughout the duration of the study."
164074|NCT01697592|O6|Outcome|Omarigliptin 25mg/SU (Phase B)|"Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.~Participants continued prestudy basal medication of SU throughout the duration of the study."
164075|NCT01697592|O5|Outcome|Omarigliptin 25 mg/α-GI (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.
164076|NCT01697592|O4|Outcome|Omarigliptin 25 mg/TZD (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
164077|NCT01697592|O3|Outcome|Omarigliptin 25 mg/BG (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
164078|NCT01697592|O2|Outcome|Omarigliptin 25 mg/Gln (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.
164079|NCT01697592|O1|Outcome|Omarigliptin 25 mg/SU (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
164080|NCT01697592|O10|Outcome|Placebo/α-GI (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
164081|NCT01697592|O9|Outcome|Placebo/TZD (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
164082|NCT01697592|O8|Outcome|Placebo/BG (Phase A)|Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
164083|NCT01697592|O7|Outcome|Placebo/Gln. (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
164084|NCT01697592|O6|Outcome|Placebo/SU (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
164085|NCT01697592|O5|Outcome|Omarigliptin 25 mg/α-GI (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
164086|NCT01697592|O4|Outcome|Omarigliptin 25 mg/TZD (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
164087|NCT01697592|O3|Outcome|Omarigliptin 25 mg/BG (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
164088|NCT01697592|O2|Outcome|Omarigliptin 25 mg/Gln (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
164089|NCT01697592|O1|Outcome|Omarigliptin 25 mg/SU (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
164090|NCT01697592|E12|Reported Event|Omarigliptin 25mg/ABM (Phase B)|"Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.~Participants continued any prestudy basal medications throughout the duration of the study."
164091|NCT01697592|E11|Reported Event|Omarigliptin 25 mg/α-GI (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.
164092|NCT01697592|E10|Reported Event|Omarigliptin 25 mg/TZD (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
164093|NCT01697592|E9|Reported Event|Omarigliptin 25 mg/BG (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
164094|NCT01697592|E8|Reported Event|Omarigliptin 25 mg/Gln (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.
164095|NCT01697592|E7|Reported Event|Omarigliptin 25 mg/SU (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
164096|NCT01697592|E6|Reported Event|Placebo/ABM (Phase A)|Placebo to omargliptin administered orally once weekly for 24 weeks during Phase A. Participants continued any pre-study basal medication (ABM)throughout the duration of the study.
164097|NCT01697592|E5|Reported Event|Omarigliptin 25 mg/α-GI (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
164098|NCT01697592|E4|Reported Event|Omarigliptin 25 mg/TZD (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
164099|NCT01697592|E3|Reported Event|Omarigliptin 25 mg/BG (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
164100|NCT01697592|E2|Reported Event|Omarigliptin 25 mg/Gln (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
164101|NCT01697592|E1|Reported Event|Omarigliptin 25 mg/SU (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
164102|NCT01697579|B6|Baseline|Total|Total of all reporting groups
164103|NCT01697579|B5|Baseline|Placebo Control-Cycle 1|Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
164104|NCT01697579|B4|Baseline|Fosaprepitant 0.4 mg/Kg-Cycle 1|Participants 12 to 17 years old were administered 20 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 0.4 mg/kg (not to exceed 20 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
164105|NCT01697579|B3|Baseline|Fosaprepitant 1.2 mg/Kg-Cycle 1|Participants 12 to 17 years old were administered 60 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 1.2 mg/kg (not to exceed 60 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
164106|NCT01697579|B2|Baseline|Fosaprepitant 3 mg/Kg-Cycle 1|Participants 12 to 17 years old were administered 150 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 3 mg/kg (not to exceed 150 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
164107|NCT01697579|B1|Baseline|Fosaprepitant 5 mg/Kg-Cycle 1|Participants were administered intravenous (IV) fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
164108|NCT01697579|P7|Participant Flow|Fosaprepitant 3 mg/Kg-Cycles 2-6|For optional Cycles 2-6, participants from Cycle 1 fosaprepitant arms (3, 1.2, or 0.4 mg/kg) or Cycle 1 control arm were administered fosaprepitant 3 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5-HT3 antagonist with or without dexamethasone.
164109|NCT01697579|P6|Participant Flow|Fosaprepitant 5 mg/Kg-Cycles 2-6|For optional Cycles 2-6, participants from the 5 mg/kg fosaprepitant arm in Cycle 1 were administered fosaprepitant 5 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5- hydroxytryptamine 3 (5-HT3) antagonist with or without dexamethasone. Participants 1 year or less were required to receive ondansetron in all cycles as the 5-HT3 antagonist.
164110|NCT01697579|P5|Participant Flow|Placebo Control-Cycle 1|Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
164111|NCT01697579|P4|Participant Flow|Fosaprepitant 0.4 mg/Kg-Cycle 1|Participants 12 to 17 years old were administered 20 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 0.4 mg/kg (not to exceed 20 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
164112|NCT01697579|P3|Participant Flow|Fosaprepitant 1.2 mg/Kg-Cycle 1|Participants 12 to 17 years old were administered 60 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 1.2 mg/kg (not to exceed 60 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
164113|NCT01697579|P2|Participant Flow|Fosaprepitant 3 mg/Kg-Cycle 1|Participants 12 to 17 years old were administered 150 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 3 mg/kg (not to exceed 150 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
164114|NCT01697579|P1|Participant Flow|Fosaprepitant 5 mg/Kg-Cycle 1|Participants were administered intravenous (IV) fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
164115|NCT01697579|O2|Outcome|Fosaprepitant 3 mg/Kg-Cycles 2-6|For optional Cycles 2-6, participants from Cycle 1 fosaprepitant arms (3, 1.2, or 0.4 mg/kg) or Cycle 1 control arm were administered fosaprepitant 3 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5-HT3 antagonist with or without dexamethasone.
164116|NCT01697579|O1|Outcome|Fosaprepitant 5 mg/Kg-Cycles 2-6|For optional Cycles 2-6, participants from the 5 mg/kg fosaprepitant arm in Cycle 1 were administered fosaprepitant 5 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5- hydroxytryptamine 3 (5-HT3) antagonist with or without dexamethasone. Participants 1 year or less were required to receive ondansetron in all cycles as the 5-HT3 antagonist.
164117|NCT01697579|O5|Outcome|Placebo Control-Cycle 1|Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
164118|NCT01697579|O4|Outcome|Fosaprepitant 0.4 mg/Kg-Cycle 1|Participants 12 to 17 years old were administered 20 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 0.4 mg/kg (not to exceed 20 mg). Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
183479|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
164119|NCT01697579|O3|Outcome|Fosaprepitant 1.2 mg/Kg-Cycle 1|Participants 12 to 17 years old were administered 60 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 1.2 mg/kg (not to exceed 60 mg). Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
164120|NCT01697579|O2|Outcome|Fosaprepitant 3 mg/Kg-Cycle 1|Participants 12 to 17 years old were administered 150 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 3 mg/kg (not to exceed 150 mg). Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
164121|NCT01697579|O1|Outcome|Fosaprepitant 5 mg/Kg-Cycle 1|Participants were administered intravenous (IV) fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
164122|NCT01697579|O3|Outcome|Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 20 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164123|NCT01697579|O2|Outcome|Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 60 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164124|NCT01697579|O1|Outcome|Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 150 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164125|NCT01697579|O3|Outcome|Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 20 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164126|NCT01697579|O2|Outcome|Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 60 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164127|NCT01697579|O1|Outcome|Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 150 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164128|NCT01697579|O3|Outcome|Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 20 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164129|NCT01697579|O2|Outcome|Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 60 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164130|NCT01697579|O1|Outcome|Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 150 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164131|NCT01697579|O3|Outcome|Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 20 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164132|NCT01697579|O2|Outcome|Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 60 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164133|NCT01697579|O1|Outcome|Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 150 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164134|NCT01697579|O3|Outcome|Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 20 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164135|NCT01697579|O2|Outcome|Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 60 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164136|NCT01697579|O1|Outcome|Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 150 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164137|NCT01697579|O3|Outcome|Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 20 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164138|NCT01697579|O2|Outcome|Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 60 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164139|NCT01697579|O1|Outcome|Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 150 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164140|NCT01697579|O3|Outcome|Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 20 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164141|NCT01697579|O2|Outcome|Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 60 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164142|NCT01697579|O1|Outcome|Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 150 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164143|NCT01697579|O3|Outcome|Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 20 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164144|NCT01697579|O2|Outcome|Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 60 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164469|NCT01696643|O2|Outcome|Placebo|Placebo, administered orally, BID for 52 weeks
164470|NCT01696643|O1|Outcome|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
164145|NCT01697579|O1|Outcome|Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 1|Participants were administered 150 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164146|NCT01697579|O4|Outcome|Fosaprepitant 0.4 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164147|NCT01697579|O3|Outcome|Fosaprepitant 1.2 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164148|NCT01697579|O2|Outcome|Fosaprepitant 3 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164149|NCT01697579|O1|Outcome|Fosaprepitant 5 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164150|NCT01697579|O4|Outcome|Fosaprepitant 0.4 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164151|NCT01697579|O3|Outcome|Fosaprepitant 1.2 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164152|NCT01697579|O2|Outcome|Fosaprepitant 3 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164153|NCT01697579|O1|Outcome|Fosaprepitant 5 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164154|NCT01697579|O4|Outcome|Fosaprepitant 0.4 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164155|NCT01697579|O3|Outcome|Fosaprepitant 1.2 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164156|NCT01697579|O2|Outcome|Fosaprepitant 3 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164157|NCT01697579|O1|Outcome|Fosaprepitant 5 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164158|NCT01697579|O4|Outcome|Fosaprepitant 0.4 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164159|NCT01697579|O3|Outcome|Fosaprepitant 1.2 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164160|NCT01697579|O2|Outcome|Fosaprepitant 3 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164161|NCT01697579|O1|Outcome|Fosaprepitant 5 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164162|NCT01697579|O4|Outcome|Fosaprepitant 0.4 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164163|NCT01697579|O3|Outcome|Fosaprepitant 1.2 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164164|NCT01697579|O2|Outcome|Fosaprepitant 3 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164165|NCT01697579|O1|Outcome|Fosaprepitant 5 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164166|NCT01697579|O4|Outcome|Fosaprepitant 0.4 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164167|NCT01697579|O3|Outcome|Fosaprepitant 1.2 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164168|NCT01697579|O2|Outcome|Fosaprepitant 3 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164169|NCT01697579|O1|Outcome|Fosaprepitant 5 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
183480|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
164170|NCT01697579|O4|Outcome|Fosaprepitant 0.4 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164171|NCT01697579|O3|Outcome|Fosaprepitant 1.2 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164172|NCT01697579|O2|Outcome|Fosaprepitant 3 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164173|NCT01697579|O1|Outcome|Fosaprepitant 5 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164174|NCT01697579|O4|Outcome|Fosaprepitant 0.4 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164175|NCT01697579|O3|Outcome|Fosaprepitant 1.2 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164176|NCT01697579|O2|Outcome|Fosaprepitant 3 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164177|NCT01697579|O1|Outcome|Fosaprepitant 5 mg/kg: 6 to <12 Years-Cycle 1|Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164178|NCT01697579|O4|Outcome|Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164179|NCT01697579|O3|Outcome|Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164180|NCT01697579|O2|Outcome|Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164181|NCT01697579|O1|Outcome|Fosaprepitant 5 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164182|NCT01697579|O4|Outcome|Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164183|NCT01697579|O3|Outcome|Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164184|NCT01697579|O2|Outcome|Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164185|NCT01697579|O1|Outcome|Fosaprepitant 5 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164186|NCT01697579|O4|Outcome|Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164187|NCT01697579|O3|Outcome|Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164188|NCT01697579|O2|Outcome|Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164189|NCT01697579|O1|Outcome|Fosaprepitant 5 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164190|NCT01697579|O4|Outcome|Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164191|NCT01697579|O3|Outcome|Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164192|NCT01697579|O2|Outcome|Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164193|NCT01697579|O1|Outcome|Fosaprepitant 5 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164194|NCT01697579|O4|Outcome|Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164471|NCT01696643|O1|Outcome|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
164195|NCT01697579|O3|Outcome|Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164196|NCT01697579|O2|Outcome|Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164197|NCT01697579|O1|Outcome|Fosaprepitant 5 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164198|NCT01697579|O4|Outcome|Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164199|NCT01697579|O3|Outcome|Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164200|NCT01697579|O2|Outcome|Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164201|NCT01697579|O1|Outcome|Fosaprepitant 5 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164202|NCT01697579|O4|Outcome|Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164203|NCT01697579|O3|Outcome|Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164204|NCT01697579|O2|Outcome|Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164205|NCT01697579|O1|Outcome|Fosaprepitant 5 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164206|NCT01697579|O4|Outcome|Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164207|NCT01697579|O3|Outcome|Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164208|NCT01697579|O2|Outcome|Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164209|NCT01697579|O1|Outcome|Fosaprepitant 5 mg/kg: 2 to <6 Years-Cycle 1|Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
164210|NCT01697579|O1|Outcome|Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1|Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; and participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
164211|NCT01697579|O1|Outcome|Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1|Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; and participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
164212|NCT01697579|O1|Outcome|Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1|Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; and participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
164213|NCT01697579|O1|Outcome|Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1|Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; and participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
164214|NCT01697579|O1|Outcome|Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1|Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; and participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
164372|NCT01696981|O1|Outcome|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
164215|NCT01697579|O1|Outcome|Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1|Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; and participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
164216|NCT01697579|O1|Outcome|Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1|Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; and participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
164217|NCT01697579|O1|Outcome|Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1|Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; and participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
164218|NCT01697579|E7|Reported Event|Fosaprepitant 5 mg/Kg-Cycles 2-6|For optional Cycles 2-6, participants from the 5 mg/kg fosaprepitant arm in Cycle 1 were administered fosaprepitant 5 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5- hydroxytryptamine 3 (5-HT3) antagonist with or without dexamethasone. Participants 1 year or less were required to receive ondansetron in all cycles as the 5-HT3 antagonist.
164219|NCT01697579|E6|Reported Event|Fosaprepitant 3 mg/Kg-Cycles 2-6|For optional Cycles 2-6, participants from Cycle 1 fosaprepitant arms (3, 1.2, or 0.4 mg/kg) or Cycle 1 control arm were administered fosaprepitant 3 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5-HT3 antagonist with or without dexamethasone.
164220|NCT01697579|E5|Reported Event|Placebo Control-Cycle 1|Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
164221|NCT01697579|E4|Reported Event|Fosaprepitant 5 mg/Kg-Cycle 1|Participants were administered intravenous (IV) fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
164222|NCT01697579|E3|Reported Event|Fosaprepitant 3 mg/Kg-Cycle 1|Participants 12 to 17 years old were administered 150 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 3 mg/kg (not to exceed 150 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
164223|NCT01697579|E2|Reported Event|Fosaprepitant 1.2 mg/Kg-Cycle 1|Participants 12 to 17 years old were administered 60 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 1.2 mg/kg (not to exceed 60 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
164224|NCT01697579|E1|Reported Event|Fosaprepitant 0.4 mg/Kg-Cycle 1|Participants 12 to 17 years old were administered 20 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 0.4 mg/kg (not to exceed 20 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
164225|NCT01697501|B1|Baseline|Chronic Hepatitis B Patients|Interleukin 28B testing: Blood sampling for IL28B genotyping
164226|NCT01697501|P1|Participant Flow|Chronic Hepatitis B Patients|Interleukin 28B testing: Blood sampling for IL28B genotyping
164227|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs8099917
164228|NCT01697501|O4|Outcome|"GT+GG"|at IL28B genotype rs8099917
164229|NCT01697501|O3|Outcome|"GG"|at IL28B genotype rs8099917
164230|NCT01697501|O2|Outcome|"GT"|at IL28B genotype rs8099917
164231|NCT01697501|O1|Outcome|"TT"|at IL28B genotype rs8099917
164232|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs12979860
164233|NCT01697501|O4|Outcome|"TC+TT"|at IL28B genotype rs12979860
164234|NCT01697501|O3|Outcome|"TT"|at IL28B genotype rs12979860
164235|NCT01697501|O2|Outcome|"TC"|at IL28B genotype rs12979860
164236|NCT01697501|O1|Outcome|"CC"|at IL28B genotype rs12979860
164237|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs8099917
164238|NCT01697501|O4|Outcome|"GT+GG"|at IL28B genotype rs8099917
164239|NCT01697501|O3|Outcome|"GG"|at IL28B genotype rs8099917
164240|NCT01697501|O2|Outcome|"GT"|at IL28B genotype rs8099917
164241|NCT01697501|O1|Outcome|"TT"|at IL28B genotype rs8099917
164242|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs12979860
164243|NCT01697501|O4|Outcome|"TC+TT"|at IL28B genotype rs12979860
164244|NCT01697501|O3|Outcome|"TT"|at IL28B genotype rs12979860
164245|NCT01697501|O2|Outcome|"TC"|at IL28B genotype rs12979860
164246|NCT01697501|O1|Outcome|"CC"|at IL28B genotype rs12979860
164247|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs8099917
164248|NCT01697501|O4|Outcome|"GT+GG"|at IL28B genotype rs8099917
164249|NCT01697501|O3|Outcome|"GG"|at IL28B genotype rs8099917
164250|NCT01697501|O2|Outcome|"GT"|at IL28B genotype rs8099917
164251|NCT01697501|O1|Outcome|"TT"|at IL28B genotype rs8099917
164252|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs12979860
164253|NCT01697501|O4|Outcome|"TC+TT"|at IL28B genotype rs12979860
164254|NCT01697501|O3|Outcome|"TT"|at IL28B genotype rs12979860
164255|NCT01697501|O2|Outcome|"TC"|at IL28B genotype rs12979860
164268|NCT01697462|B1|Baseline|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
164269|NCT01697462|P1|Participant Flow|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of metastatic colorectal cancer (mCRC) were followed until progression of the disease (PD), unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
164270|NCT01697462|O1|Outcome|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
164271|NCT01697462|O1|Outcome|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
164272|NCT01697462|O1|Outcome|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
164273|NCT01697462|O1|Outcome|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
164274|NCT01697462|E1|Reported Event|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
164275|NCT01697449|B1|Baseline|CRC Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
164276|NCT01697449|P1|Participant Flow|Colorectal Cancer (CRC) Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
164277|NCT01697449|O1|Outcome|CRC Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
164278|NCT01697449|O1|Outcome|CRC Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
164279|NCT01697449|O1|Outcome|Unresectable|Participants with unresectable metastatic CRC at baseline received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent..
164280|NCT01697449|O2|Outcome|Unresectable CRC at Baseline|Participants with unresectable metastatic CRC at baseline received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent..
164281|NCT01697449|O1|Outcome|Resectable/Potentially Resectable CRC at Baseline|Participants with resectable metastatic CRC at baseline received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent..
164282|NCT01697449|O1|Outcome|CRC Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
164283|NCT01697449|E1|Reported Event|CRC Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
164284|NCT01697358|B3|Baseline|Total|Total of all reporting groups
164285|NCT01697358|B2|Baseline|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
164286|NCT01697358|B1|Baseline|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
164287|NCT01697358|P2|Participant Flow|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
164288|NCT01697358|P1|Participant Flow|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
164289|NCT01697358|O2|Outcome|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
164290|NCT01697358|O1|Outcome|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
164291|NCT01697358|O2|Outcome|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
164292|NCT01697358|O1|Outcome|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
164293|NCT01697358|O2|Outcome|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
164294|NCT01697358|O1|Outcome|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
164295|NCT01697358|O2|Outcome|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
164296|NCT01697358|O1|Outcome|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
164297|NCT01697358|O2|Outcome|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
164298|NCT01697358|O1|Outcome|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
164299|NCT01697358|O2|Outcome|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
164300|NCT01697358|O1|Outcome|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
164301|NCT01697358|E2|Reported Event|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
164302|NCT01697358|E1|Reported Event|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
164303|NCT01697345|B1|Baseline|Vaginal Testosterone|Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).
164304|NCT01697345|P1|Participant Flow|Vaginal Testosterone|Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).
164305|NCT01697345|O2|Outcome|Did Not Continue Vaginal Testosterone Therapy|Participants who chose not to continue vaginal testosterone upon completion of the study.
164306|NCT01697345|O1|Outcome|Continued Vaginal Testosterone Therapy|Participants who chose to continue vaginal testosterone therapy upon completion of the study.
164307|NCT01697345|O2|Outcome|FSFI Pain Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
164308|NCT01697345|O1|Outcome|FSFI Pain Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
164309|NCT01697345|O2|Outcome|FSFI Satisfaction Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
164310|NCT01697345|O1|Outcome|FSFI Satisfaction Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
164311|NCT01697345|O2|Outcome|FSFI Orgasm Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
164312|NCT01697345|O1|Outcome|FSFI Orgasm Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
164313|NCT01697345|O2|Outcome|FSFI Lubrication Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
164314|NCT01697345|O1|Outcome|FSFI Lubrication Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
164315|NCT01697345|O2|Outcome|FSFI Arousal Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
164316|NCT01697345|O1|Outcome|FSFI Arousal Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
164317|NCT01697345|O2|Outcome|FSFI Desire Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
164318|NCT01697345|O1|Outcome|FSFI Desire Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
164319|NCT01697345|O2|Outcome|FSFI Total Score (Postteset)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
164320|NCT01697345|O1|Outcome|FSFI Total Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
164397|NCT01696968|O2|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
164321|NCT01697345|E1|Reported Event|Vaginal Testosterone|Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).
164322|NCT01697332|B1|Baseline|Subjects With and Without COPD|"All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function.~Hyperpolarized 129Xe gas: 800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon."
164323|NCT01697332|P1|Participant Flow|Subjects With and Without COPD|"All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function.~Hyperpolarized 129Xe gas: 800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon."
164324|NCT01697332|O1|Outcome|Subjects With and Without COPD|"All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function.~Hyperpolarized 129Xe gas: 800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon."
164325|NCT01697332|O1|Outcome|Subjects With and Without COPD|"All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function.~Hyperpolarized 129Xe gas: 800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon."
164326|NCT01697332|O1|Outcome|Subjects With and Without COPD|"All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function.~Hyperpolarized 129Xe gas: 800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon."
164327|NCT01697332|E1|Reported Event|Subjects With and Without COPD|"All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function.~Hyperpolarized 129Xe gas: 800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon."
164328|NCT01697319|B1|Baseline|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
164329|NCT01697319|P1|Participant Flow|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
164330|NCT01697319|O1|Outcome|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
164331|NCT01697319|O1|Outcome|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
164332|NCT01697319|O1|Outcome|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
164333|NCT01697319|O1|Outcome|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
164334|NCT01697319|E1|Reported Event|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
164335|NCT01696994|B3|Baseline|Total|Total of all reporting groups
164336|NCT01696994|B2|Baseline|Ovarian Screening|Participants undergo blood sample collection for Cancer Antigen 125 (CA-125) analysis at baseline and annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
164337|NCT01696994|B1|Baseline|Control|Participants receive standard medical care. Participants complete a baseline questionnaire (BQ) at entry and a dietary history questionnaire (DHQ) during study years 0-6.
164338|NCT01696994|P2|Participant Flow|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
164339|NCT01696994|P1|Participant Flow|Control|Participants receive standard medical care.
164340|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
164341|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
164342|NCT01696994|O2|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
164343|NCT01696994|O1|Outcome|Control|Participants receive standard medical care.
164344|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
164345|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
164398|NCT01696968|O1|Outcome|Control|Participants receive standard medical care.
164346|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
164347|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
164348|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
164349|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
164350|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
164351|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
164352|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
164353|NCT01696994|O2|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
164354|NCT01696994|O1|Outcome|Control|Participants receive standard medical care.
164355|NCT01696994|O2|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
164356|NCT01696994|O1|Outcome|Control|Participants receive standard medical care.
164357|NCT01696994|O2|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
164358|NCT01696994|O1|Outcome|Control|Participants receive standard medical care.
164359|NCT01696994|O2|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
164360|NCT01696994|O1|Outcome|Control|Participants receive standard medical care.
164361|NCT01696994|O2|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
164362|NCT01696994|O1|Outcome|Control|Participants receive standard medical care.
164363|NCT01696994|E1|Reported Event|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
164364|NCT01696981|B3|Baseline|Total|Total of all reporting groups
164365|NCT01696981|B2|Baseline|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
164366|NCT01696981|B1|Baseline|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
164367|NCT01696981|P2|Participant Flow|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
164368|NCT01696981|P1|Participant Flow|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
164369|NCT01696981|O1|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
164370|NCT01696981|O1|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
164371|NCT01696981|O2|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
164472|NCT01696643|O2|Outcome|Placebo|Placebo, administered orally, BID for 52 weeks
164373|NCT01696981|O1|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
164374|NCT01696981|O2|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
164375|NCT01696981|O1|Outcome|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
164376|NCT01696981|O2|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
164377|NCT01696981|O1|Outcome|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
164378|NCT01696981|O2|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
164379|NCT01696981|O1|Outcome|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
164380|NCT01696981|O2|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
164381|NCT01696981|O1|Outcome|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
164382|NCT01696981|O2|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
164383|NCT01696981|O1|Outcome|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
164384|NCT01696981|E1|Reported Event|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
164385|NCT01696968|B3|Baseline|Total|Total of all reporting groups
164386|NCT01696968|B2|Baseline|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
164387|NCT01696968|B1|Baseline|Control|Participants receive standard medical care.
164388|NCT01696968|P2|Participant Flow|Lung Screening|"Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
164389|NCT01696968|P1|Participant Flow|Control|Participants receive standard medical care.
164390|NCT01696968|O1|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
164391|NCT01696968|O1|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
164392|NCT01696968|O2|Outcome|Lung Screening|"Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
164393|NCT01696968|O1|Outcome|Control|Participants receive standard medical care.
164394|NCT01696968|O1|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
164395|NCT01696968|O1|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
164396|NCT01696968|O1|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
164473|NCT01696643|O1|Outcome|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
164399|NCT01696968|O2|Outcome|Lung Screening|"Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
164400|NCT01696968|O1|Outcome|Control|Participants receive standard medical care.
164401|NCT01696968|O2|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
164402|NCT01696968|O1|Outcome|Control|Participants receive standard medical care.
164403|NCT01696968|O2|Outcome|Lung Screening|"Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
164404|NCT01696968|O1|Outcome|Control|Participants receive standard medical care.
164405|NCT01696968|O2|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
164406|NCT01696968|O1|Outcome|Control|Participants receive standard medical care.
164407|NCT01696968|E1|Reported Event|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
164408|NCT01696942|B3|Baseline|Total|Total of all reporting groups
164409|NCT01696942|B2|Baseline|Mesalamine Treatment Arm|"Beginning at 4 weeks after surgery, patients would be randomly assigned to receive mesalamine 800 mg orally three times daily for twelve months following enrollment.~Mesalamine: mesalamine 800 mg orally three times daily"
164410|NCT01696942|B1|Baseline|Cimzia Treatment Arm|"Beginning at 4 weeks after surgery, patients would be randomly assigned using a pulled card method to receive certolizumab at a dose of 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks thereafter up to 12 months after enrollment.~Cimzia: 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks"
164411|NCT01696942|P2|Participant Flow|Mesalamine Treatment Arm|"Beginning at 4 weeks after surgery, patients would be randomly assigned to receive mesalamine 800 mg orally three times daily for twelve months following enrollment.~Mesalamine: mesalamine 800 mg orally three times daily"
164412|NCT01696942|P1|Participant Flow|Cimzia Treatment Arm|"Beginning at 4 weeks after surgery, patients would be randomly assigned using a pulled card method to receive certolizumab at a dose of 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks thereafter up to 12 months after enrollment.~Cimzia: 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks"
164413|NCT01696942|O2|Outcome|Mesalamine Treatment Arm|"Beginning at 4 weeks after surgery, patients would be randomly assigned to receive mesalamine 800 mg orally three times daily for twelve months following enrollment.~Mesalamine: mesalamine 800 mg orally three times daily"
164414|NCT01696942|O1|Outcome|Cimzia Treatment Arm|"Beginning at 4 weeks after surgery, patients would be randomly assigned using a pulled card method to receive certolizumab at a dose of 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks thereafter up to 12 months after enrollment.~Cimzia: 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks"
164415|NCT01696942|O2|Outcome|Mesalamine Treatment Arm|"Beginning at 4 weeks after surgery, patients would be randomly assigned to receive mesalamine 800 mg orally three times daily for twelve months following enrollment.~Mesalamine: mesalamine 800 mg orally three times daily"
164416|NCT01696942|O1|Outcome|Cimzia Treatment Arm|"Beginning at 4 weeks after surgery, patients would be randomly assigned using a pulled card method to receive certolizumab at a dose of 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks thereafter up to 12 months after enrollment.~Cimzia: 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks"
164417|NCT01696942|E2|Reported Event|Mesalamine Treatment Arm|"Beginning at 4 weeks after surgery, patients would be randomly assigned to receive mesalamine 800 mg orally three times daily for twelve months following enrollment.~Mesalamine: mesalamine 800 mg orally three times daily"
164418|NCT01696942|E1|Reported Event|Cimzia Treatment Arm|"Beginning at 4 weeks after surgery, patients would be randomly assigned using a pulled card method to receive certolizumab at a dose of 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks thereafter up to 12 months after enrollment.~Cimzia: 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks"
164419|NCT01696929|B1|Baseline|Tocilizumab|"Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.~Tocilizumab: Therapeutic/Pharmacologic Class of Drug:~Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.~Type of Dosage Form:~Concentrate for solution for infusion.~Route of Administration:~Intravenous (i.v.) infusion."
164420|NCT01696929|P1|Participant Flow|Tocilizumab|"Following a screening evaluation, participants will receive two infusions of Tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of Tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.~Tocilizumab: Therapeutic/Pharmacological Class of Drug:~Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.~Type of Dosage Form:~Concentrate for solution for infusion.~Route of Administration:~Intravenous (i.v.) infusion."
164421|NCT01696929|O1|Outcome|Tocilizumab|"Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.~Tocilizumab: Therapeutic/Pharmacologic Class of Drug:~Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.~Type of Dosage Form:~Concentrate for solution for infusion.~Route of Administration:~Intravenous (i.v.) infusion."
164446|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
164474|NCT01696643|O2|Outcome|Placebo|Placebo, administered orally, BID for 52 weeks
164422|NCT01696929|O1|Outcome|Tocilizumab|"Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.~Tocilizumab: Therapeutic/Pharmacologic Class of Drug:~Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.~Type of Dosage Form:~Concentrate for solution for infusion.~Route of Administration:~Intravenous (i.v.) infusion."
164423|NCT01696929|E1|Reported Event|Tocilizumab|"Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.~Tocilizumab: Therapeutic/Pharmacologic Class of Drug:~Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.~Type of Dosage Form:~Concentrate for solution for infusion.~Route of Administration:~Intravenous (i.v.) infusion."
164424|NCT01696773|B3|Baseline|Total|Total of all reporting groups
164425|NCT01696773|B2|Baseline|Red Tomato Juice First, Then Tangerine Tomato Juice|Red tomato juice is consumed on day 14, then tangerine tomato juice on day 28
164426|NCT01696773|B1|Baseline|Tangerine Tomato Juice First, Then Red Tomato Juice|Tangerine tomato juice is consumed on day 14 then red tomato juice on day 28
164427|NCT01696773|P2|Participant Flow|Red Tomato Juice First, Then Tangerine Tomato Juice|Red tomato juice will be fed, followed by a 14 day washout, then tangerine tomato juice will be fed.
164428|NCT01696773|P1|Participant Flow|Tangerine Tomato Juice First, Then Red Tomato Juice|Tangerine tomato juice will be fed, followed by a 14 day washout, and then red tomato juice will be fed
164429|NCT01696773|O2|Outcome|Red Tomato Juice|"Red tomato juice will be fed~Red tomato juice: Post-prandial feeding study"
164430|NCT01696773|O1|Outcome|Tangerine Tomato Juice|"Tangerine tomato juice will be fed~Tangerine tomato juice: Post-prandial feeding study"
164431|NCT01696773|E2|Reported Event|Red Tomato Juice|"Red tomato juice will be fed~Red tomato juice: Post-prandial feeding study"
164432|NCT01696773|E1|Reported Event|Tangerine Tomato Juice|"Tangerine tomato juice will be fed~Tangerine tomato juice: Post-prandial feeding study"
164433|NCT01696760|B3|Baseline|Total|Total of all reporting groups
164434|NCT01696760|B2|Baseline|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
164435|NCT01696760|B1|Baseline|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
164436|NCT01696760|P2|Participant Flow|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
164437|NCT01696760|P1|Participant Flow|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
164438|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
164439|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
164440|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
164441|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
164442|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
164443|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
164444|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
164445|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
164467|NCT01696643|P2|Participant Flow|Placebo|Placebo, administered orally, BID for 52 weeks
164447|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
164448|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
164449|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
164450|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
164451|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
164452|NCT01696760|E2|Reported Event|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
164453|NCT01696760|E1|Reported Event|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
164454|NCT01696695|B1|Baseline|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
164455|NCT01696695|P1|Participant Flow|Metastatic Colorectal Carcinoma (mCRC) Participants|Newly diagnosed metastatic colorectal carcinoma (mCRC) participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
164456|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
164457|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
164458|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
164459|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
164460|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
164461|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
164462|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
164463|NCT01696695|E1|Reported Event|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
164464|NCT01696643|B3|Baseline|Total|Total of all reporting groups
164465|NCT01696643|B2|Baseline|Placebo|Placebo, administered orally, BID for 52 weeks
164466|NCT01696643|B1|Baseline|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
164481|NCT01696643|E1|Reported Event|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
164482|NCT01696357|B3|Baseline|Total|Total of all reporting groups
164483|NCT01696357|B2|Baseline|Adolescents Without Asthma|"Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
164484|NCT01696357|B1|Baseline|Adolescents With Asthma|"Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
164485|NCT01696357|P2|Participant Flow|Adolescents Without Asthma|"Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
164486|NCT01696357|P1|Participant Flow|Adolescents With Asthma|"Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
164487|NCT01696357|O2|Outcome|Adolescents Without Asthma|"Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
164488|NCT01696357|O1|Outcome|Adolescents With Asthma|"Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
164489|NCT01696357|E2|Reported Event|Adolescents Without Asthma|"Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
164490|NCT01696357|E1|Reported Event|Adolescents With Asthma|"Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
164491|NCT01696214|B5|Baseline|Total|Total of all reporting groups
164492|NCT01696214|B4|Baseline|Fluticasone 250 mg/Salmeterol 50mg|"Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, tiotroprium, and montelukast.~Fluticasone 250 mg/salmeterol 50 mg:~Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50"
164493|NCT01696214|B3|Baseline|Montelukast|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and tiotroprium.~Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks."
164494|NCT01696214|B2|Baseline|Theophylline|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 300 mg once a day for 24 weeks with placebo tiotroprium and montelukast.~Theophylline: Participants will be assigned to theophylline 300 mg once a day for 24 weeks"
164495|NCT01696214|B1|Baseline|Ipratropium|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and montelukast.~Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times"
164496|NCT01696214|P4|Participant Flow|Fluticasone 250 mg/Salmeterol 50mg|"Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, placebo ipratropium, and placebo montelukast.~Fluticasone 250 mg/salmeterol 50 mg:~Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50"
164497|NCT01696214|P3|Participant Flow|Montelukast|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and placebo ipratropium.~Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks."
164498|NCT01696214|P2|Participant Flow|Theophylline|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 400 mg once a day for 24 weeks with placebo ipratropium and placebo montelukast.~Theophylline: Participants will be assigned to theophylline 400 mg once a day for 24 weeks"
164499|NCT01696214|P1|Participant Flow|Ipratropium|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and placebo montelukast.~Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times"
164500|NCT01696214|O4|Outcome|Fluticasone 250 mg/Salmeterol 50mg|"Participants will be assigned to inhaled fluticasone 250/salmeterol 50 twice a day for 24 weeks with placebo theophylline, ipratropium, and montelukast.~Fluticasone 250 mg/salmeterol 50 mg: Drug: Fluticasone 250 mg/salmeterol 50 mg Participants will be assigned to a 24 week treatment with inhaled fluticasone/salmeterol or matching placebo"
164501|NCT01696214|O3|Outcome|Montelukast|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and ipratropium.~Montelukast 10mg: Participants will be assigned to Leukotriene receptor antagonist once a day for 24 weeks."
164502|NCT01696214|O2|Outcome|Theophylline|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 400 mg once a day for 24 weeks with placebo ipratropium and montelukast.~Theophylline 400 mg: Participants will be assigned to Theophylline once a day for 24 weeks"
164503|NCT01696214|O1|Outcome|Ipratropium|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 2.5 mL, 0.02% 3 times daily via mini nebulizer with placebo theophylline and montelukast.~ipratropium: Participants will be assigned to ipratropium 2.5 mL of 0.02% solution via mini nebulizer 3 times a day day for 24 weeks."
164504|NCT01696214|E4|Reported Event|Fluticasone 250 mg/Salmeterol 50mg|"Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, tiotroprium, and montelukast.~Fluticasone 250 mg/salmeterol 50 mg:~Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50"
164505|NCT01696214|E3|Reported Event|Montelukast|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and tiotroprium.~Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks."
164506|NCT01696214|E2|Reported Event|Theophylline|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 300 mg once a day for 24 weeks with placebo tiotroprium and montelukast.~Theophylline: Participants will be assigned to theophylline 300 mg once a day for 24 weeks"
164507|NCT01696214|E1|Reported Event|Ipratropium|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and montelukast.~Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times"
164508|NCT01696188|B3|Baseline|Total|Total of all reporting groups
164509|NCT01696188|B2|Baseline|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plan approach.~interscalene nerve catheter"
164510|NCT01696188|B1|Baseline|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.~interscalene nerve catheter"
164511|NCT01696188|P2|Participant Flow|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.~interscalene nerve catheter"
164512|NCT01696188|P1|Participant Flow|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.~interscalene nerve catheter"
164513|NCT01696188|O2|Outcome|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.~interscalene nerve catheter"
164514|NCT01696188|O1|Outcome|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.~interscalene nerve catheter"
164515|NCT01696188|O2|Outcome|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.~interscalene nerve catheter"
164516|NCT01696188|O1|Outcome|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.~interscalene nerve catheter"
164517|NCT01696188|O2|Outcome|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.~interscalene nerve catheter"
164518|NCT01696188|O1|Outcome|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.~interscalene nerve catheter"
164519|NCT01696188|O2|Outcome|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.~interscalene nerve catheter"
164520|NCT01696188|O1|Outcome|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.~interscalene nerve catheter"
164521|NCT01696188|E2|Reported Event|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.~interscalene nerve catheter"
164522|NCT01696188|E1|Reported Event|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.~interscalene nerve catheter"
164523|NCT01696084|B3|Baseline|Total|Total of all reporting groups
164524|NCT01696084|B2|Baseline|Arm B (7+3)|Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
164525|NCT01696084|B1|Baseline|Arm A (CPX-351)|Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
164548|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
164549|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
164526|NCT01696084|P2|Participant Flow|Arm B (7+3)|Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
164527|NCT01696084|P1|Participant Flow|Arm A (CPX-351)|Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
164528|NCT01696084|O2|Outcome|Arm B (7+3)|Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
164529|NCT01696084|O1|Outcome|Arm A (CPX-351)|Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
164530|NCT01696084|O2|Outcome|Arm B (7+3)|Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
164531|NCT01696084|O1|Outcome|Arm A (CPX-351)|Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
164532|NCT01696084|O2|Outcome|Arm B (7+3)|Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
164533|NCT01696084|O1|Outcome|Arm A (CPX-351)|Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
164534|NCT01696084|O2|Outcome|Arm B (7+3)|Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
164535|NCT01696084|O1|Outcome|Arm A (CPX-351)|Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
164536|NCT01696084|O2|Outcome|Arm B (7+3)|Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
164537|NCT01696084|O1|Outcome|Arm A (CPX-351)|Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
164538|NCT01696084|O2|Outcome|Arm B (7+3)|Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
164539|NCT01696084|O1|Outcome|Arm A (CPX-351)|Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
164540|NCT01696084|E2|Reported Event|Arm B (7+3)|Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
164541|NCT01696084|E1|Reported Event|Arm A (CPX-351)|Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
164542|NCT01696071|B1|Baseline|Baseline Total|Total number of patients randomised and treated in the study.
164543|NCT01696071|P2|Participant Flow|Tio R5 QD / Tio R2.5 BID|"Subjects were randomised to receive treatment with 2.5 μg tiotropium inhalation solution twice daily (i.e. in the morning and in the evening) and 5 μg tiotropium inhalation solution once daily in the evening via Respimat inhaler in a crossover manner using a predefined randomisation sequence.~Treatment 1: Tio 5 µg QD (once daily):Oral inhalation via the( Tiotropium–Respimat) inhaler of 5 µg once daily i.e 2 actuations of 2.5 µg tiotropium in the evening and 2 actuations of placebo in the morning (total daily dose of 5 μg) Treatment 2: Tio 2.5 µg BID (twice daily):Oral inhalation via the( Tiotropium–Respimat) inhaler of 2.5 µg twice daily i.e 2 actuations of 1.25 µg tiotropium in the morning and in the evening (total daily dose of 5 μg)"
164544|NCT01696071|P1|Participant Flow|Tio R2.5 Twice Daily (BID) / Tio R5 Once Daily (QD)|"Subjects were randomised to receive treatment with 2.5 μg tiotropium inhalation solution twice daily (i.e. in the morning and in the evening) and 5 μg tiotropium inhalation solution once daily in the evening via Respimat inhaler in a crossover manner using a predefined randomisation sequence.~Treatment 1: Tio 2.5 µg BID (twice daily):Oral inhalation via the( Tiotropium–Respimat) inhaler of 2.5 µg twice daily i.e 2 actuations of 1.25 µg tiotropium in the morning and in the evening (total daily dose of 5 μg) Treatment 2: Tio 5 µg QD (once daily):Oral inhalation via the( Tiotropium–Respimat) inhaler of 5 µg once daily i.e 2 actuations of 2.5 µg tiotropium in the evening and 2 actuations of placebo in the morning (total daily dose of 5 μg)"
164545|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
164546|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
164547|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
165495|NCT01691560|O2|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
164550|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
164551|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
164552|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
164553|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
164554|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
164555|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
164556|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
164557|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
164558|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
164559|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
164560|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
164561|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
164562|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
164563|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
164564|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
164565|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
164566|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with inhaled corticosteroid (iCS).
164567|NCT01696071|E2|Reported Event|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
164568|NCT01696071|E1|Reported Event|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
164569|NCT01696058|B3|Baseline|Total|Total of all reporting groups
164570|NCT01696058|B2|Baseline|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164571|NCT01696058|B1|Baseline|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose~Tiotropium: Marketed dose"
164572|NCT01696058|P2|Participant Flow|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164573|NCT01696058|P1|Participant Flow|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose~Tiotropium: Marketed dose"
164574|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164575|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
164576|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164577|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
164578|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164579|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
164580|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164608|NCT01696045|O1|Outcome|Ipilimumab 3mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
183481|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
164581|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
164582|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164583|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
164584|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164585|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
164586|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164587|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
164588|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164589|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
164590|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164591|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
164592|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164593|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
164594|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164595|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
164596|NCT01696058|E2|Reported Event|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164597|NCT01696058|E1|Reported Event|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
164598|NCT01696045|B3|Baseline|Total|Total of all reporting groups
164599|NCT01696045|B2|Baseline|Ipilimumab 10mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
164600|NCT01696045|B1|Baseline|Ipilimumab 3mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
164601|NCT01696045|P2|Participant Flow|Ipilimumab 10mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
164602|NCT01696045|P1|Participant Flow|Ipilimumab 3mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
164603|NCT01696045|O2|Outcome|Ipilimumab 10mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
164604|NCT01696045|O1|Outcome|Ipilimumab 3mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
164605|NCT01696045|O2|Outcome|Ipilimumab 10mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
164606|NCT01696045|O1|Outcome|Ipilimumab 3mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
164607|NCT01696045|O2|Outcome|Ipilimumab 10mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
183482|NCT01628848|E2|Reported Event|Placebo|Placebo transdermal patch
164609|NCT01696045|O2|Outcome|Ipilimumab 10mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
164610|NCT01696045|O1|Outcome|Ipilimumab 3mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
164611|NCT01696045|O2|Outcome|Ipilimumab 10mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
164612|NCT01696045|O1|Outcome|Ipilimumab 3mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
164613|NCT01696045|O2|Outcome|Ipilimumab 10mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
164614|NCT01696045|O1|Outcome|Ipilimumab 3mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
164615|NCT01696045|E2|Reported Event|IPILIMUMAB 10 MG/KG|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
164616|NCT01696045|E1|Reported Event|IPILIMUMAB 3 MG/KG|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
164617|NCT01695993|B4|Baseline|Total|Total of all reporting groups
164618|NCT01695993|B3|Baseline|Arm 3|"Handout with expectancy- enhancing component~Relaxation MP3 with expectancy- enhancing component~Acupressure bands"
164619|NCT01695993|B2|Baseline|Arm 2|"Handout without expectancy- enhancing component~Relaxation MP3 without expectancy-enhancing component~Acupressure bands"
164620|NCT01695993|B1|Baseline|Arm 1|Patients will receive only the handout without expectancy enhancing component
164621|NCT01695993|P3|Participant Flow|Arm 3|"Handout with expectancy- enhancing component~Relaxation MP3 with expectancy- enhancing component~Acupressure bands"
164622|NCT01695993|P2|Participant Flow|Arm 2|"Handout without expectancy- enhancing component~Relaxation MP3 without expectancy-enhancing component~Acupressure bands"
164623|NCT01695993|P1|Participant Flow|Arm 1|Patients will receive only the handout without the expectancy enhancing component
164624|NCT01695993|O3|Outcome|Expectancy-Enhancing Condition|"Handout with expectancy- enhancing component~Relaxation MP3 with expectancy- enhancing component~Acupressure bands"
164625|NCT01695993|O2|Outcome|Expectancy-Neutral Condition|"Handout without expectancy- enhancing component~Relaxation MP3 without expectancy-enhancing component~Acupressure bands"
164626|NCT01695993|O1|Outcome|Standard Care|Patients will receive only standard care onlyonent
164627|NCT01695993|E3|Reported Event|Arm 3|"Patients receive:~Handout with expectancy- enhancing component~Relaxation MP3 with expectancy-enhancing component~Acupressure bands"
164628|NCT01695993|E2|Reported Event|Arm 2|"Patients receive:~Handout without expectancy- enhancing component~Relaxation MP3 without expectancy-enhancing component~Acupressure bands"
164629|NCT01695993|E1|Reported Event|Arm 1|Patients will receive only standard care
164630|NCT01695772|B1|Baseline|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
164631|NCT01695772|P1|Participant Flow|Bevacizumab|Participants received standard 5-Flurouracil (5-FU) based chemotherapy plus bevacizumab 5 milligrams per kilograms (mg/kg) intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
164632|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
164633|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
164634|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
164635|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
164636|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
164637|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
164638|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
164639|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
164640|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
164641|NCT01695772|E1|Reported Event|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
164682|NCT01695304|O1|Outcome|Intervention Group|Intervention group who received ceramic water filters
164683|NCT01695304|O2|Outcome|Control Arm|Households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.
165729|NCT01691248|P2|Participant Flow|Placebo|Placebo tablet once daily for no longer than 40 days
164642|NCT01695746|B1|Baseline|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
164643|NCT01695746|P1|Participant Flow|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
164644|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
164645|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
164646|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
164647|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
164648|NCT01695746|O1|Outcome|C.E.R.A (Continuous Erythropoietin Receptor Activator)|Participants with chronic renal anemia Stage III-IV, not on dialysis, receiving therapy with C.E.R.A. according to routine clinical practice were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 μg/kg of C.E.R.A once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 μg either once monthly; or 60, 100, or 180 μg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
164649|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
164650|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
164651|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
164703|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164652|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
164653|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
164654|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
164655|NCT01695746|E1|Reported Event|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
164656|NCT01695668|B3|Baseline|Total|Total of all reporting groups
164657|NCT01695668|B2|Baseline|Restasis|Cyclosporine
164658|NCT01695668|B1|Baseline|Lotemax|Loteprednol Etabonate 0.5%
164659|NCT01695668|P2|Participant Flow|Restasis|Cyclosporine
164660|NCT01695668|P1|Participant Flow|Lotemax|Loteprednol Etabonate 0.5%
164661|NCT01695668|O2|Outcome|Restasis|Cyclosporine
164662|NCT01695668|O1|Outcome|Lotemax|Loteprednol Etabonate 0.5%
164663|NCT01695668|E2|Reported Event|Restasis|"Cyclosporine~Restasis"
164664|NCT01695668|E1|Reported Event|Lotemax|"Loteprednol Etabonate 0.5%~Lotemax"
164665|NCT01695369|B1|Baseline|Overall Study Participants|Senofilcon A and Comfilcon A
164666|NCT01695369|P1|Participant Flow|Overall Study Participants|Senofilcon A and Comfilcon A
164667|NCT01695369|O2|Outcome|Senofilcon A|Senofilcon A (Vistakon Acuvue® Oasys)
164668|NCT01695369|O1|Outcome|Comfilcon A|comfilcon A (CooperVision Biofinity®Sphere)
164669|NCT01695369|E2|Reported Event|Comfilcon A|Comfilcon A / CooperVision Biofinity Sphere
164670|NCT01695369|E1|Reported Event|Overall Study Participants|Senofilcon A and Comfilcon A
164671|NCT01695330|B1|Baseline|Subcutaneous Bortezomib|
164672|NCT01695330|P2|Participant Flow||This is one-arm study.
164673|NCT01695330|P1|Participant Flow|Subcutaneous Bortezomib|patients with MM who received treatment with a SC bortezomib-containing combination. The patients were required to have received a prior IV bortezomib containing combination regimen that differs from the SC bortezomib-containing treatment.
164674|NCT01695330|O1|Outcome|Subcutaneous Bortezomib|Patients with MM who received treatment with a SC bortezomib-containing combination
164675|NCT01695330|E1|Reported Event|Subcutaneous Bortezomib|Bortezomib was administered SC at a dose of 1.0 mg/m2. Doses were administered on days 1, 4, 8, and 11 of a 28-day cycle. When administered subcutaneously, sites for each injection (thigh or abdomen) were rotated and reported. All other drugs used in combination with the SC bortezomib were recorded in the Case Report Forms along with their corresponding doses and schedules.
164676|NCT01695304|B3|Baseline|Total|Total of all reporting groups
164677|NCT01695304|B2|Baseline|Control Arm|Households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.
164678|NCT01695304|B1|Baseline|Intervention Arm|"Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.~Ceramic water filter: In total, 120 households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water at initial entry into the study (intervention group), and 120 households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends."
164679|NCT01695304|P2|Participant Flow|Control Arm|Households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.
164680|NCT01695304|P1|Participant Flow|Intervention Arm|"Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.~Ceramic water filter: In total, 120 households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water at initial entry into the study (intervention group), and 120 households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends."
164681|NCT01695304|O2|Outcome|Control Group|Control Group who did not receive ceramic water filters (until after the trial ended)
164684|NCT01695304|O1|Outcome|Intervention Arm|"Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.~Ceramic water filter: In total, 120 households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water at initial entry into the study (intervention group), and 120 households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends."
164685|NCT01695304|E2|Reported Event|Control Arm|Households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.
164686|NCT01695304|E1|Reported Event|Intervention Arm|"Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.~Ceramic water filter: In total, 120 households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water at initial entry into the study (intervention group), and 120 households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends."
164687|NCT01695239|B5|Baseline|Total|Total of all reporting groups
164688|NCT01695239|B4|Baseline|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164689|NCT01695239|B3|Baseline|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164690|NCT01695239|B2|Baseline|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
164691|NCT01695239|B1|Baseline|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
164692|NCT01695239|P4|Participant Flow|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164693|NCT01695239|P3|Participant Flow|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab (ixe) Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164694|NCT01695239|P2|Participant Flow|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
164695|NCT01695239|P1|Participant Flow|Placebo|Participants received placebo for ixekizumab as 2 subcutaneous (SC) injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections every 2 weeks (Q2W) from Week 2 to Week 24.
164696|NCT01695239|O3|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164697|NCT01695239|O2|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164698|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
164699|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164700|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164701|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
164702|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
164786|NCT01695044|P1|Participant Flow|Arm 1: PSMA ADC|PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.
164704|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164705|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
164706|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
164707|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164708|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164709|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
164710|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
164711|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164712|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164713|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
164714|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
164715|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164716|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164717|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
164718|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
164719|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164720|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164721|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
164722|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
164723|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
183483|NCT01628848|E1|Reported Event|SPM 962|SPM 962 transdermal patch
164724|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164725|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
164726|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
164727|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164728|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164729|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
164730|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
164731|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164732|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164733|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
164734|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
164735|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164736|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164737|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
164738|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
164739|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164740|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164741|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
164742|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
164743|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
183484|NCT01628692|B7|Baseline|Total|Total of all reporting groups
164744|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164745|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
164746|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
164747|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164748|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164749|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
164750|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
164751|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164752|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164753|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
164754|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
164755|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164756|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164757|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
164758|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
164759|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164760|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164761|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
164762|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
164763|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
183843|NCT01627002|O1|Outcome|Part B 3.0 mg PA401|
164764|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164765|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
164766|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
164767|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164768|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164769|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
164770|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
164771|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164772|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164773|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
164774|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
164775|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164776|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164777|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
164778|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
164779|NCT01695239|E4|Reported Event|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164780|NCT01695239|E3|Reported Event|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
164781|NCT01695239|E2|Reported Event|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
164782|NCT01695239|E1|Reported Event|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
164783|NCT01695044|B3|Baseline|Total|Total of all reporting groups
164784|NCT01695044|B2|Baseline|Arm 2: PSMA ADC Chemotherapy-naive|PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles.
164785|NCT01695044|B1|Baseline|Arm 1: PSMA ADC Chemotherapy-experienced|PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.
183844|NCT01627002|O3|Outcome|Part B Placebo|
164787|NCT01695044|O2|Outcome|Chemotherapy-naive|"PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles.~The chemotherapy-naïve group was comprised of 35 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it."
164788|NCT01695044|O1|Outcome|PSMA ADC Chemotherapy-experienced|"PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles.~The chemotherapy-experienced group was comprised of 84 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation)."
164789|NCT01695044|O2|Outcome|Chemotherapy-naive|"PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles.~The chemotherapy-naïve group was comprised of 35 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it."
164790|NCT01695044|O1|Outcome|PSMA ADC Chemotherapy-experienced|"PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles.~The chemotherapy-experienced group was comprised of 84 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation)."
164791|NCT01695044|O2|Outcome|Chemotherapy-naive|"Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) administered IV at 2.3 mg/kg Q3W for 8 cycles.~The chemotherapy-naïve group was comprised of 35 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it."
164792|NCT01695044|O1|Outcome|PSMA ADC Chemotherapy-experienced|"Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) administered IV at 2.3 mg/kg Q3W for 8 cycles.~The chemotherapy-experienced group was comprised of 84 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation)."
164793|NCT01695044|E2|Reported Event|Chemotherapy-naive|PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles. The chemotherapy-naïve group was comprised of 35 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.
164794|NCT01695044|E1|Reported Event|PSMA ADC Chemotherapy-experienced|PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles. The chemotherapy-experienced group was comprised of 84 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).
164795|NCT01694966|B4|Baseline|Total|Total of all reporting groups
164796|NCT01694966|B3|Baseline|Placebo|"Oral dose, 8 Placebo tablets over a 4hr schedule~Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet."
164797|NCT01694966|B2|Baseline|Methylene Blue MMX® 100mg|"Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule~Methylene Blue MMX®~Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet."
164798|NCT01694966|B1|Baseline|Methylene Blue MMX® 200mg|"Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule~Methylene Blue MMX®"
164799|NCT01694966|P3|Participant Flow|Placebo|"Oral dose, 8 Placebo tablets over a 4hr schedule~Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet."
164800|NCT01694966|P2|Participant Flow|Methylene Blue MMX® 100mg|"Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule~Methylene Blue MMX®~Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet."
164801|NCT01694966|P1|Participant Flow|Methylene Blue MMX® 200mg|"Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule~Methylene Blue MMX®"
164802|NCT01694966|O3|Outcome|Placebo|"Oral dose, 8 Placebo tablets over a 4hr schedule~Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet."
164803|NCT01694966|O2|Outcome|Methylene Blue MMX® 100mg|"Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule~Methylene Blue MMX®~Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet."
164804|NCT01694966|O1|Outcome|Methylene Blue MMX® 200mg|"Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule~Methylene Blue MMX®"
164805|NCT01694966|E3|Reported Event|Placebo|"Oral dose, 8 Placebo tablets over a 4hr schedule~Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet."
164806|NCT01694966|E2|Reported Event|Methylene Blue MMX® 100mg|"Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule~Methylene Blue MMX®~Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet."
164807|NCT01694966|E1|Reported Event|Methylene Blue MMX® 200mg|"Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule~Methylene Blue MMX®"
164808|NCT01694771|B3|Baseline|Total|Total of all reporting groups
164809|NCT01694771|B2|Baseline|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164810|NCT01694771|B1|Baseline|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose~Tiotropium: Marketed dose"
164811|NCT01694771|P2|Participant Flow|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164812|NCT01694771|P1|Participant Flow|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose~Tiotropium: Marketed dose"
164813|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164814|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
164815|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164816|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
164817|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164818|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
164819|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164820|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
164821|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164822|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
164823|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164824|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
164825|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164826|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
164827|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164828|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
164829|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164830|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
164831|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164832|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
164833|NCT01694771|E2|Reported Event|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
164834|NCT01694771|E1|Reported Event|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
164882|NCT01694420|B1|Baseline|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
164883|NCT01694420|P1|Participant Flow|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
164835|NCT01694706|B1|Baseline|Entire Study Population|"All subjects received all tested treatments in a randomised, open label, 3-way cross over study. The treatments were:~Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)~Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less.~Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir.~Drug administrations were separated by a washout period of at least 14 days"
164836|NCT01694706|P3|Participant Flow|Faldaprevir+ OMP/ Faldaprevir Fed/ Faldaprevir|"Faldaprevir+ OMP: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir.~Faldaprevir fed: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less.~Faldaprevir: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration"
164837|NCT01694706|P2|Participant Flow|Faldaprevir Fed/ Faldaprevir/ Faldaprevir+ OMP|"Faldaprevir fed: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less.~Faldaprevir: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)~faldaprevir+ OMP: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir."
164838|NCT01694706|P1|Participant Flow|Faldaprevir/Faldaprevir+ OMP/Faldaprevir Fed|"Faldaprevir: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration.~Faldaprevir+ OMP: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir.~Faldaprevir fed: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less."
164839|NCT01694706|O3|Outcome|Faldaprevir and Omeprazole|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir
164840|NCT01694706|O2|Outcome|Faldaprevir After a High-fat Meal|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less
164841|NCT01694706|O1|Outcome|Faldaprevir in Fasting|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)
164842|NCT01694706|O3|Outcome|Faldaprevir and Omeprazole|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir
164843|NCT01694706|O2|Outcome|Faldaprevir After a High-fat Meal|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less
164844|NCT01694706|O1|Outcome|Faldaprevir in Fasting|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)
164845|NCT01694706|O3|Outcome|Faldaprevir and Omeprazole|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir
164846|NCT01694706|O2|Outcome|Faldaprevir After a High-fat Meal|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less
164847|NCT01694706|O1|Outcome|Faldaprevir in Fasting|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)
164848|NCT01694706|E4|Reported Event|Omeprazole|40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir
164849|NCT01694706|E3|Reported Event|Faldaprevir and Omeprazole|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast
164850|NCT01694706|E2|Reported Event|Faldaprevir After a High-fat Meal|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less
164851|NCT01694706|E1|Reported Event|Faldaprevir in Fasting|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)
164852|NCT01694667|B3|Baseline|Total|Total of all reporting groups
164853|NCT01694667|B2|Baseline|Placebo|Participants randomized to placebo
164854|NCT01694667|B1|Baseline|Omega-3|Participants randomized to omega-3
164855|NCT01694667|P2|Participant Flow|Placebo|"Placebo packets will have same orange-flavored pudding with an identical appearance and taste, but will include safflower oil instead of the fish oil.~Omega-3 Fatty Acids: Omega-3 fatty acids will be delivered in orange-flavored pudding packets (Coromega®, Vista, CA). Each packet contains 650 mg of omega-3 fatty acids, 350mg of eicosapentanoic acid (EPA), 230mg of docosahexanoic acid (DHA) and 2,000 mg of fish oil 18/12, and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA).~28 participants allocated to this group."
164856|NCT01694667|P1|Participant Flow|Omega-3 Fatty Acids|"Omega-3 fatty acids will be delivered in orange-flavored pudding packets and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA).~Omega-3 Fatty Acids: Omega-3 fatty acids will be delivered in orange-flavored pudding packets (Coromega®, Vista, CA). Each packet contains 650 mg of omega-3 fatty acids, 350mg of eicosapentanoic acid (EPA), 230mg of docosahexanoic acid (DHA) and 2,000 mg of fish oil 18/12, and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA).~29 participants allocated to this group."
164857|NCT01694667|O2|Outcome|Placebo|Participants randomized to placebo
164858|NCT01694667|O1|Outcome|Omega-3|Participants randomized to omega-3
164859|NCT01694667|O2|Outcome|Placebo|Participants randomized to placebo
164860|NCT01694667|O1|Outcome|Omega-3|Participants randomized to omega-3
164861|NCT01694667|O2|Outcome|Placebo|Participants randomized to placebo
164862|NCT01694667|O1|Outcome|Omega-3|Participants randomized to omega-3
164863|NCT01694667|O2|Outcome|Placebo|Participants randomized to placebo
164864|NCT01694667|O1|Outcome|Omega-3|Participants randomized to omega-3
164865|NCT01694667|O2|Outcome|Placebo|Participants randomized to placebo
164866|NCT01694667|O1|Outcome|Omega-3|Participants randomized to omega-3
164867|NCT01694667|O2|Outcome|Placebo|Participants randomized to placebo
164868|NCT01694667|O1|Outcome|Omega-3|Participants randomized to omega-3
164869|NCT01694667|E2|Reported Event|Placebo|Participants randomized to placebo
164870|NCT01694667|E1|Reported Event|Omega-3|Participants randomized to omega-3
164871|NCT01694641|B3|Baseline|Total|Total of all reporting groups
164872|NCT01694641|B2|Baseline|Standard Embryo Monitoring|Upon fertilization embryos are observed once on days 1-3-5 by the embryologist to check for development. The single embryo for transfer is selected based on actual morphology as seen under light microscope.
164873|NCT01694641|B1|Baseline|Time Lapse Embryo Observation|"Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos are placed in an incubator that is hooked up to a monitor that allows continuous embryo observation. A morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection.~time-lapse morphokinetic evaluation: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse"
164874|NCT01694641|P2|Participant Flow|Standard Embryo Monitoring|Upon fertilization embryos are observed once on days 1-3-5 by the embryologist to check for development. The single embryo for transfer is selected based on actual morphology as seen under light microscope.
164875|NCT01694641|P1|Participant Flow|Time Lapse Embryo Observation|"Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos are placed in an incubator that is hooked up to a monitor that allows continuous embryo observation. A morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection.~time-lapse morphokinetic evaluation: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse"
164876|NCT01694641|O2|Outcome|Standard Embryo Monitoring|Upon fertilization embryos are observed once on days 1-3-5 by the embryologist to check for development. The single embryo for transfer is selected based on actual morphology as seen under light microscope.
164877|NCT01694641|O1|Outcome|Time-lapse Morphokinetic Evaluation|"Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos in a petri dish that allows individual assessment (Primo Vision Dish) are placed onto an automated time-lapse equipment in an incubator. The time-lapse equipment performs imaging in 10 minutes intervals. The software is presenting the up-to-date images and allows the operator to assess the time-lapse movie of the developmental history of the embryos to perform annotations and apply evaluation/selection algorithm. This morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection, which actually describes the intervention.~time-lapse morphokinetic evaluation: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse"
164878|NCT01694641|O2|Outcome|Standard Embryo Monitoring|Upon fertilization embryos are observed once on days 1-3-5 by the embryologist to check for development. The single embryo for transfer is selected based on actual morphology as seen under light microscope.
164879|NCT01694641|O1|Outcome|Time Lapse Embryo Observation|"Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos are placed in an incubator that is hooked up to a monitor that allows continuous embryo observation. A morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection.~time-lapse morphokinetic evaluation: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse"
164880|NCT01694641|E2|Reported Event|Standard Embryo Monitoring|Upon fertilization embryos are observed once on days 1-3-5 by the embryologist to check for development. The single embryo for transfer is selected based on actual morphology as seen under light microscope.
164881|NCT01694641|E1|Reported Event|Time Lapse Embryo Observation|"Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos are placed in an incubator that is hooked up to a monitor that allows continuous embryo observation. A morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection.~time-lapse morphokinetic evaluation: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse"
164884|NCT01694420|O1|Outcome|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
164885|NCT01694420|O1|Outcome|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
164886|NCT01694420|O1|Outcome|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
164887|NCT01694420|O1|Outcome|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
164888|NCT01694420|O1|Outcome|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
164889|NCT01694420|O1|Outcome|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
164890|NCT01694420|E1|Reported Event|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
164891|NCT01694199|B3|Baseline|Total|Total of all reporting groups
164892|NCT01694199|B2|Baseline|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.~No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
164893|NCT01694199|B1|Baseline|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.~Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
164894|NCT01694199|P2|Participant Flow|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.~No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
164895|NCT01694199|P1|Participant Flow|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.~Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
164896|NCT01694199|O2|Outcome|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.~No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
164897|NCT01694199|O1|Outcome|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.~Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
164898|NCT01694199|O2|Outcome|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.~No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
164899|NCT01694199|O1|Outcome|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.~Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
164900|NCT01694199|O2|Outcome|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.~No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
164901|NCT01694199|O1|Outcome|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.~Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
164902|NCT01694199|O2|Outcome|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.~No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
164903|NCT01694199|O1|Outcome|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.~Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
164904|NCT01694199|O2|Outcome|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.~No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
164905|NCT01694199|O1|Outcome|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.~Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
164906|NCT01694199|E2|Reported Event|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.~No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
164907|NCT01694199|E1|Reported Event|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.~Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
164908|NCT01694108|B3|Baseline|Total|Total of all reporting groups
164909|NCT01694108|B2|Baseline|Control Children|No intervention
164910|NCT01694108|B1|Baseline|BCG-vaccine|SSI strain 1331 standard dose
164911|NCT01694108|P2|Participant Flow|Control Children (no Intervention)|
164912|NCT01694108|P1|Participant Flow|BCG-vaccine|
164913|NCT01694108|O2|Outcome|Face-to-face|Randomized to receive information about the study by standard face-to-face consultation.
164914|NCT01694108|O1|Outcome|Telephone|Randomized to receive information about the study by telephone
164915|NCT01694108|O2|Outcome|Declining Mothers|Mothers who decided not to let their child participate in the study
164916|NCT01694108|O1|Outcome|Participating Mothers|Mothers who decided to let their child participate in the study
164917|NCT01694108|O2|Outcome|Control Children|No intervention
164918|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
164919|NCT01694108|O2|Outcome|Control Children|No intervention
164920|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
164921|NCT01694108|O2|Outcome|Control Children|No intervention
164922|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
164923|NCT01694108|O2|Outcome|Control Children|No intervention
164924|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
164925|NCT01694108|O2|Outcome|Control Children|No intervention
164926|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
164927|NCT01694108|O2|Outcome|Control Children|No intervention
164966|NCT01693900|B2|Baseline|Intra-operative FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.~Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB."
164967|NCT01693900|B1|Baseline|Pre-operative Ultrasound FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.~Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area."
164968|NCT01693900|P2|Participant Flow|Intra-operative FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.~Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB."
164969|NCT01693900|P1|Participant Flow|Pre-operative Ultrasound FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.~Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area."
164970|NCT01693900|O2|Outcome|Intra-operative FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.~Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB."
164971|NCT01693900|O1|Outcome|Pre-operative Ultrasound FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.~Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area."
164972|NCT01693900|O2|Outcome|Intra-operative FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.~Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB."
164973|NCT01693900|O1|Outcome|Pre-operative Ultrasound FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.~Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area."
164974|NCT01693900|O2|Outcome|Intra-operative FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.~Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB."
164975|NCT01693900|O1|Outcome|Pre-operative Ultrasound FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.~Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area."
164976|NCT01693900|O2|Outcome|Intra-operative FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.~Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB."
164977|NCT01693900|O1|Outcome|Pre-operative Ultrasound FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.~Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area."
165013|NCT01693367|B1|Baseline|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
164978|NCT01693900|E2|Reported Event|Intra-operative FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.~Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB."
164979|NCT01693900|E1|Reported Event|Pre-operative Ultrasound FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.~Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area."
164980|NCT01693653|B3|Baseline|Total|Total of all reporting groups
164981|NCT01693653|B2|Baseline|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
164982|NCT01693653|B1|Baseline|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
164983|NCT01693653|P2|Participant Flow|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
164984|NCT01693653|P1|Participant Flow|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
164985|NCT01693653|O2|Outcome|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
164986|NCT01693653|O1|Outcome|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
164987|NCT01693653|O2|Outcome|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
164988|NCT01693653|O1|Outcome|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
164989|NCT01693653|O2|Outcome|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
164990|NCT01693653|O1|Outcome|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
164991|NCT01693653|O2|Outcome|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
164992|NCT01693653|O1|Outcome|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
164993|NCT01693653|O2|Outcome|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
164994|NCT01693653|O1|Outcome|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
164995|NCT01693653|O2|Outcome|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
164996|NCT01693653|O1|Outcome|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
164997|NCT01693653|O2|Outcome|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
164998|NCT01693653|O1|Outcome|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
164999|NCT01693653|O2|Outcome|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
165000|NCT01693653|O1|Outcome|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
165001|NCT01693653|O2|Outcome|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
165002|NCT01693653|O1|Outcome|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
165003|NCT01693653|O2|Outcome|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
165004|NCT01693653|O1|Outcome|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
165005|NCT01693653|E2|Reported Event|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
165006|NCT01693653|E1|Reported Event|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
165007|NCT01693484|B1|Baseline|Operative Calcaneus Fracture|Patients with indications for and electing to undergo operative repair of intra articular calcaneus fracture through extended lateral approach
165008|NCT01693484|P1|Participant Flow|Displaced Intra Articular Calcaneus Fracture|displaced intra articular calcaneus fracture with operative repair
165009|NCT01693484|O1|Outcome|ICG Administered|"The ICG dose (10 mg/4cc per image capture) will be administered in its entirety via push injection through IV access established for standard surgical procedure, followed by 10 cc Normal Saline bolus. This ICG dose will be administered twice, 1X prior to anesthesia, and 1X after the tourniquet on operative extremity has been removed for at least 15 minutes.~ICG (Indocyanine Green): Diagnostic drug used for visualisation of blood perfusion in various tissues.Administered intravenously, 2X: 1X prior to anesthesia, and 1X after tourniquet on operative extremity has been released for at least 15 minutes. When excited by laser light source, it subsequently emits at a near infrared frequency."
165010|NCT01693484|E1|Reported Event|Unanticipated Adverse Events Related to ICG|No adverse events related to administration ICG
165011|NCT01693367|B3|Baseline|Total|Total of all reporting groups
165012|NCT01693367|B2|Baseline|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
183845|NCT01627002|O2|Outcome|Part B 1.0 mg PA401|
165014|NCT01693367|P2|Participant Flow|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
165015|NCT01693367|P1|Participant Flow|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
165016|NCT01693367|O2|Outcome|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
165017|NCT01693367|O1|Outcome|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
165018|NCT01693367|O2|Outcome|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
165019|NCT01693367|O1|Outcome|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
165020|NCT01693367|O2|Outcome|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
165021|NCT01693367|O1|Outcome|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
165022|NCT01693367|O2|Outcome|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
165023|NCT01693367|O1|Outcome|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
165024|NCT01693367|O2|Outcome|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
165025|NCT01693367|O1|Outcome|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
165026|NCT01693367|O2|Outcome|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
165027|NCT01693367|O1|Outcome|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
165028|NCT01693367|E2|Reported Event|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
165029|NCT01693367|E1|Reported Event|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
165030|NCT01693185|B3|Baseline|Total|Total of all reporting groups
165031|NCT01693185|B2|Baseline|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
165032|NCT01693185|B1|Baseline|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
165033|NCT01693185|P2|Participant Flow|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
165034|NCT01693185|P1|Participant Flow|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
165035|NCT01693185|O2|Outcome|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
165036|NCT01693185|O1|Outcome|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
165037|NCT01693185|O2|Outcome|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
165038|NCT01693185|O1|Outcome|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
165039|NCT01693185|O2|Outcome|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
165068|NCT01693068|O3|Outcome|Pimasertib (Crossover)|Subjects who were randomized and received dacarbazine and were allowed to crossover to pimasertib treatment on progression of their disease.
165040|NCT01693185|O1|Outcome|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
165041|NCT01693185|O2|Outcome|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
165042|NCT01693185|O1|Outcome|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
165043|NCT01693185|O2|Outcome|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
165044|NCT01693185|O1|Outcome|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
165045|NCT01693185|O2|Outcome|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
165046|NCT01693185|O1|Outcome|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
165047|NCT01693185|E2|Reported Event|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
165048|NCT01693185|E1|Reported Event|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
165049|NCT01693120|B1|Baseline|Ablation|"Phased RF ablation~Medtronic Phased RF Ablation System: Phased RF ablation"
165050|NCT01693120|P1|Participant Flow|Ablation|"Phased RF ablation~Medtronic Phased RF Ablation System: Phased RF ablation"
165051|NCT01693120|O1|Outcome|Ablation|"Phased RF ablation~Medtronic Phased RF Ablation System: Phased RF ablation"
165052|NCT01693120|O1|Outcome|Ablation|"Phased RF ablation~Medtronic Phased RF Ablation System: Phased RF ablation"
165053|NCT01693120|O1|Outcome|Ablation|"Phased RF ablation~Medtronic Phased RF Ablation System: Phased RF ablation"
165054|NCT01693120|O1|Outcome|Ablation|"Phased RF ablation~Medtronic Phased RF Ablation System: Phased RF ablation"
165055|NCT01693120|E1|Reported Event|Ablation|"Phased RF ablation~Medtronic Phased RF Ablation System: Phased RF ablation"
165056|NCT01693068|B3|Baseline|Total|Total of all reporting groups
165057|NCT01693068|B2|Baseline|Pimasertib|Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
165058|NCT01693068|B1|Baseline|Dacarbazine|Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
165059|NCT01693068|P3|Participant Flow|Pimasertib (Crossover)|Subjects who were randomized and received dacarbazine and were allowed to crossover to pimasertib treatment on progression of their disease.
165060|NCT01693068|P2|Participant Flow|Pimasertib|Subjects received pimasertib orally as monotherapy at a dose of 60 milligram (mg) twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
165061|NCT01693068|P1|Participant Flow|Dacarbazine|Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
165062|NCT01693068|O3|Outcome|Pimasertib (Crossover)|Subjects who were randomized and received dacarbazine and were allowed to crossover to pimasertib treatment on progression of their disease.
165063|NCT01693068|O2|Outcome|Pimasertib|Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
165064|NCT01693068|O1|Outcome|Dacarbazine|Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
165065|NCT01693068|O3|Outcome|Pimasertib (Crossover)|Subjects who were randomized and received dacarbazine and were allowed to crossover to pimasertib treatment on progression of their disease.
165066|NCT01693068|O2|Outcome|Pimasertib|Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
165067|NCT01693068|O1|Outcome|Dacarbazine|Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
165069|NCT01693068|O2|Outcome|Pimasertib|Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
165070|NCT01693068|O1|Outcome|Dacarbazine|Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
165071|NCT01693068|O2|Outcome|Pimasertib|Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
165072|NCT01693068|O1|Outcome|Dacarbazine|Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
165073|NCT01693068|O2|Outcome|Pimasertib|Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
165074|NCT01693068|O1|Outcome|Dacarbazine|Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
165075|NCT01693068|O2|Outcome|Pimasertib|Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
165076|NCT01693068|O1|Outcome|Dacarbazine|Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
165077|NCT01693068|O2|Outcome|Pimasertib|Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
165078|NCT01693068|O1|Outcome|Dacarbazine|Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
165079|NCT01693068|O2|Outcome|Pimasertib|Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
165080|NCT01693068|O1|Outcome|Dacarbazine|Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
165081|NCT01693068|O2|Outcome|Pimasertib|Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
165082|NCT01693068|O1|Outcome|Dacarbazine|Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
165083|NCT01693068|O2|Outcome|Pimasertib|Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
165084|NCT01693068|O1|Outcome|Dacarbazine|Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
165085|NCT01693068|O2|Outcome|Pimasertib|Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
165086|NCT01693068|O1|Outcome|Dacarbazine|Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
165087|NCT01693068|E3|Reported Event|Pimasertib (Crossover)|Subjects who were randomized and received dacarbazine and were allowed to crossover to pimasertib treatment on progression of their disease.
165088|NCT01693068|E2|Reported Event|Pimasertib|Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
165144|NCT01692782|O2|Outcome|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
165089|NCT01693068|E1|Reported Event|Dacarbazine|Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
165090|NCT01693029|B3|Baseline|Total|Total of all reporting groups
165091|NCT01693029|B2|Baseline|US-licensed Epoetin Alfa|"US-licensed recombinant human epoetin alfa~US-licensed epoetin alfa: Solution for subcutaneous injection."
165092|NCT01693029|B1|Baseline|HX575 Epoetin Alfa|"HX575, recombinant human epoetin alfa~HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL."
165093|NCT01693029|P2|Participant Flow|US-licensed Epoetin Alfa|"US-licensed recombinant human epoetin alfa~US-licensed epoetin alfa: Solution for subcutaneous injection."
165094|NCT01693029|P1|Participant Flow|HX575 Epoetin Alfa|"HX575, recombinant human epoetin alfa~HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL."
165095|NCT01693029|O2|Outcome|US-licensed Epoetin Alfa|"US-licensed recombinant human epoetin alfa~US-licensed epoetin alfa: Solution for subcutaneous injection."
165096|NCT01693029|O1|Outcome|HX575 Epoetin Alfa|"HX575, recombinant human epoetin alfa~HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL."
165097|NCT01693029|O2|Outcome|US-licensed Epoetin Alfa|"US-licensed recombinant human epoetin alfa~US-licensed epoetin alfa: Solution for subcutaneous injection."
165098|NCT01693029|O1|Outcome|HX575 Epoetin Alfa|"HX575, recombinant human epoetin alfa~HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL."
165099|NCT01693029|O2|Outcome|US-licensed Epoetin Alfa|"US-licensed recombinant human epoetin alfa~US-licensed epoetin alfa: Solution for subcutaneous injection."
165100|NCT01693029|O1|Outcome|HX575 Epoetin Alfa|"HX575, recombinant human epoetin alfa~HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL."
165101|NCT01693029|O2|Outcome|US-licensed Epoetin Alfa|"US-licensed recombinant human epoetin alfa~US-licensed epoetin alfa: Solution for subcutaneous injection."
165102|NCT01693029|O1|Outcome|HX575 Epoetin Alfa|"HX575, recombinant human epoetin alfa~HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL."
165103|NCT01693029|E2|Reported Event|US-licensed Epoetin Alfa|"US-licensed recombinant human epoetin alfa~US-licensed epoetin alfa: Solution for subcutaneous injection."
165104|NCT01693029|E1|Reported Event|HX575 Epoetin Alfa|"HX575, recombinant human epoetin alfa~HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL."
165105|NCT01692951|B5|Baseline|Total|Total of all reporting groups
165106|NCT01692951|B4|Baseline|Control Matched to Squamous Cell|"Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
165107|NCT01692951|B3|Baseline|Lung Squamous Cell Carcinoma Patients|"Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung squamous cell carcinoma was based on pathologic analysis.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
165108|NCT01692951|B2|Baseline|Control Matched to Adenocarcinoma|"Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
165109|NCT01692951|B1|Baseline|Lung Adenocarcinoma Patients|"Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung adenocarcinoma was based on pathologic analysis.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
165110|NCT01692951|P4|Participant Flow|Control Matched to Squamous Cell|"Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
165111|NCT01692951|P3|Participant Flow|Lung Squamous Cell Carcinoma Patients|"Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung squamous cell carcinoma was based on pathologic analysis.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
165142|NCT01692782|O1|Outcome|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
165143|NCT01692782|O3|Outcome|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
183846|NCT01627002|O1|Outcome|Part B 3.0 mg PA401|
165112|NCT01692951|P2|Participant Flow|Control Matched to Adenocarcinoma|"Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
165113|NCT01692951|P1|Participant Flow|Lung Adenocarcinoma Patients|"Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung adenocarcinoma was based on pathologic analysis.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
165114|NCT01692951|O4|Outcome|Control Matched to Squamous Cell|"Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
165115|NCT01692951|O3|Outcome|Lung Squamous Cell Carcinoma Patients|"Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung squamous cell carcinoma was based on pathologic analysis.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
165116|NCT01692951|O2|Outcome|Control Matched to Adenocarcinoma|"Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
165117|NCT01692951|O1|Outcome|Lung Adenocarcinoma Patients|"Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung adenocarcinoma was based on pathologic analysis.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
165118|NCT01692951|E4|Reported Event|Control Matched to Squamous Cell|"Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
165119|NCT01692951|E3|Reported Event|Lung Squamous Cell Carcinoma Patients|"Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung squamous cell carcinoma was based on pathologic analysis.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
165120|NCT01692951|E2|Reported Event|Control Matched to Adenocarcinoma|"Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
165121|NCT01692951|E1|Reported Event|Lung Adenocarcinoma Patients|"Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung adenocarcinoma was based on pathologic analysis.~serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
165122|NCT01692938|B3|Baseline|Total|Total of all reporting groups
165123|NCT01692938|B2|Baseline|Retinal Disease|
165124|NCT01692938|B1|Baseline|No Retinal Disease|
165125|NCT01692938|P2|Participant Flow|Retinal Disease|
165126|NCT01692938|P1|Participant Flow|No Retinal Disease|
165127|NCT01692938|O2|Outcome|Retinal Disease|
165128|NCT01692938|O1|Outcome|No Retinal Disease|
165129|NCT01692938|O2|Outcome|Retinal Disease|
165130|NCT01692938|O1|Outcome|No Retinal Disease|
165131|NCT01692938|E2|Reported Event|Retinal Disease|
165132|NCT01692938|E1|Reported Event|No Retinal Disease|
165133|NCT01692782|B4|Baseline|Total|Total of all reporting groups
165134|NCT01692782|B3|Baseline|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
165135|NCT01692782|B2|Baseline|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 8mg once daily"
165136|NCT01692782|B1|Baseline|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily"
165137|NCT01692782|P3|Participant Flow|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
165138|NCT01692782|P2|Participant Flow|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
165139|NCT01692782|P1|Participant Flow|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
165140|NCT01692782|O3|Outcome|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
165141|NCT01692782|O2|Outcome|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
165730|NCT01691248|P1|Participant Flow|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
165145|NCT01692782|O1|Outcome|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
165146|NCT01692782|O3|Outcome|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
165147|NCT01692782|O2|Outcome|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
165148|NCT01692782|O1|Outcome|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
165149|NCT01692782|O3|Outcome|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
165150|NCT01692782|O2|Outcome|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
165151|NCT01692782|O1|Outcome|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
165152|NCT01692782|O3|Outcome|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
165153|NCT01692782|O2|Outcome|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
165154|NCT01692782|O1|Outcome|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
165155|NCT01692782|O3|Outcome|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
165156|NCT01692782|O2|Outcome|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
165157|NCT01692782|O1|Outcome|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
165158|NCT01692782|E3|Reported Event|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
165159|NCT01692782|E2|Reported Event|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
165160|NCT01692782|E1|Reported Event|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
165161|NCT01692730|B3|Baseline|Total|Total of all reporting groups
165162|NCT01692730|B2|Baseline|Basic Web Assisted Intervention.|"Basic Web Assisted Tobacco Intervention. A basic website for cessation comparable to those for general adult populations, including established evidence-based cessation information and features.~Basic Web Assisted Tobacco Intervention: Subjects at community college campuses will be directed to a cessation website with current Public Health Service Guideline information and effective smoking cessation strategies, and with minimal interactive web-based features."
165163|NCT01692730|B1|Baseline|Enhanced Web Assisted Intervention|"Enhanced Web Assisted Tobacco Intervention. An enhanced and highly interactive website for cessation.~Enhanced Web Assisted Tobacco Intervention: Subjects at community college campuses will be directed to a cessation website with current Public Health Service Guideline information and effective smoking cessation strategies, and some combination of novel interactive and social network features, including a variety of better-practice features recommended recent literature, and technologically advanced proactive features (e-mails, SMS texting, and social networking)."
165164|NCT01692730|P2|Participant Flow|Basic Web Assisted Intervention.|"Basic Web Assisted Tobacco Intervention. A basic website for cessation comparable to those for general adult populations, including established evidence-based cessation information and features.~Basic Web Assisted Tobacco Intervention: Subjects at community college campuses will be directed to a cessation website with current Public Health Service Guideline information and effective smoking cessation strategies, and with minimal interactive web-based features."
165165|NCT01692730|P1|Participant Flow|Enhanced Web Assisted Intervention|"Enhanced Web Assisted Tobacco Intervention. An enhanced and highly interactive website for cessation.~Enhanced Web Assisted Tobacco Intervention: Subjects at community college campuses will be directed to a cessation website with current Public Health Service Guideline information and effective smoking cessation strategies, and some combination of novel interactive and social network features, including a variety of better-practice features recommended recent literature, and technologically advanced proactive features (e-mails, SMS texting, and social networking)."
165166|NCT01692730|O2|Outcome|Basic Web Assisted Intervention.|"Basic Web Assisted Tobacco Intervention. A basic website for cessation comparable to those for general adult populations, including established evidence-based cessation information and features.~Basic Web Assisted Tobacco Intervention: Subjects at community college campuses will be directed to a cessation website with current Public Health Service Guideline information and effective smoking cessation strategies, and with minimal interactive web-based features."
165167|NCT01692730|O1|Outcome|Enhanced Web Assisted Intervention|"Enhanced Web Assisted Tobacco Intervention. An enhanced and highly interactive website for cessation.~Enhanced Web Assisted Tobacco Intervention: Subjects at community college campuses will be directed to a cessation website with current Public Health Service Guideline information and effective smoking cessation strategies, and some combination of novel interactive and social network features, including a variety of better-practice features recommended recent literature, and technologically advanced proactive features (e-mails, SMS texting, and social networking)."
165168|NCT01692730|O2|Outcome|Basic Web Assisted Intervention.|"Basic Web Assisted Tobacco Intervention. A basic website for cessation comparable to those for general adult populations, including established evidence-based cessation information and features.~Basic Web Assisted Tobacco Intervention: Subjects at community college campuses will be directed to a cessation website with current Public Health Service Guideline information and effective smoking cessation strategies, and with minimal interactive web-based features."
165192|NCT01692340|O2|Outcome|Isotopically Labeled Phytoene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
165169|NCT01692730|O1|Outcome|Enhanced Web Assisted Intervention|"Enhanced Web Assisted Tobacco Intervention. An enhanced and highly interactive website for cessation.~Enhanced Web Assisted Tobacco Intervention: Subjects at community college campuses will be directed to a cessation website with current Public Health Service Guideline information and effective smoking cessation strategies, and some combination of novel interactive and social network features, including a variety of better-practice features recommended recent literature, and technologically advanced proactive features (e-mails, SMS texting, and social networking)."
165170|NCT01692730|E2|Reported Event|Basic Web Assisted Intervention.|"Basic Web Assisted Tobacco Intervention. A basic website for cessation comparable to those for general adult populations, including established evidence-based cessation information and features.~Basic Web Assisted Tobacco Intervention: Subjects at community college campuses will be directed to a cessation website with current Public Health Service Guideline information and effective smoking cessation strategies, and with minimal interactive web-based features."
165171|NCT01692730|E1|Reported Event|Enhanced Web Assisted Intervention|"Enhanced Web Assisted Tobacco Intervention. An enhanced and highly interactive website for cessation.~Enhanced Web Assisted Tobacco Intervention: Subjects at community college campuses will be directed to a cessation website with current Public Health Service Guideline information and effective smoking cessation strategies, and some combination of novel interactive and social network features, including a variety of better-practice features recommended recent literature, and technologically advanced proactive features (e-mails, SMS texting, and social networking)."
165172|NCT01692691|B1|Baseline|Received Treatment|Dacarbazine Carmustine participants
165173|NCT01692691|P1|Participant Flow|Dacarbazine Carmustine|All patients received chemotherapy with Dacarbazine and Carmustine
165174|NCT01692691|O1|Outcome|Dacarbazine Carmustine|All patients received chemotherapy with Dacarbazine and Carmustine
165175|NCT01692691|O1|Outcome|Response Rate|Dacarbazine Carmustine
165176|NCT01692691|O1|Outcome|Participants 8 Week Survival.|Number of participants who received Dacarbazine + Carmustine Progression Free survival at 8 weeks
165177|NCT01692691|E1|Reported Event|Received Treatment|Number of Participants who received Dacarbazine Carmustine
165178|NCT01692626|B1|Baseline|Investigational Cream/Placebo Cream|"Patients will apply a thin layer of the investigational cream twice daily for four weeks (unless rash worsens sooner) to one half of face at the same time the are started on cetuximab. Patients will be provided with a placebo cream to apply to the other side of their face. The study coordinator will instruct the patient regarding which side of the face to apply the investigational cream. This will be randomly assigned by the study coordinator based on a randomization list generated by the biostatistics core and will only be known to the study coordinator.~Pimecrolimus: Pimecrolimus 1% topical cream twice daily for four weeks."
165179|NCT01692626|P2|Participant Flow|Right Side Investigational Cream / Placebo on Left Side|"Patients will apply a thin layer of the investigational cream twice daily for four weeks (unless rash worsens sooner) to one half of face at the same time the are started on cetuximab. Patients will be provided with a placebo cream to apply to the other side of their face. The study coordinator will instruct the patient regarding which side of the face to apply the investigational cream. This will be randomly assigned by the study coordinator based on a randomization list generated by the biostatistics core and will only be known to the study coordinator.~Pimecrolimus: Pimecrolimus 1% topical cream twice daily for four weeks."
165180|NCT01692626|P1|Participant Flow|Left Side Investigational Cream/Placebo Cream on Right Side|"Patients will apply a thin layer of the investigational cream twice daily for four weeks (unless rash worsens sooner) to one half of face at the same time the are started on cetuximab. Patients will be provided with a placebo cream to apply to the other side of their face. The study coordinator will instruct the patient regarding which side of the face to apply the investigational cream. This will be randomly assigned by the study coordinator based on a randomization list generated by the biostatistics core and will only be known to the study coordinator.~Pimecrolimus: Pimecrolimus 1% topical cream twice daily for four weeks."
165181|NCT01692626|O2|Outcome|The Right Side the Pimecrolimus Cream|The right side of the face that the pimecrolimus cream was applied.
165182|NCT01692626|O1|Outcome|Left sidePimecrolimus Cream|The left side of the face that the Pimecrolimus Cream was applied.
165183|NCT01692626|E1|Reported Event|Investigational Cream/Placebo Cream|"Patients will apply a thin layer of the investigational cream twice daily for four weeks (unless rash worsens sooner) to one half of face at the same time the are started on cetuximab. Patients will be provided with a placebo cream to apply to the other side of their face. The study coordinator will instruct the patient regarding which side of the face to apply the investigational cream. This will be randomly assigned by the study coordinator based on a randomization list generated by the biostatistics core and will only be known to the study coordinator.~Pimecrolimus: Pimecrolimus 1% topical cream twice daily for four weeks."
165184|NCT01692340|B4|Baseline|Total|Total of all reporting groups
165185|NCT01692340|B3|Baseline|Isotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
165186|NCT01692340|B2|Baseline|Isotopically Labeled Phytoene|"3.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
165187|NCT01692340|B1|Baseline|Isotopically Labeled Lycopene|"10.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
165188|NCT01692340|P3|Participant Flow|Istotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
165189|NCT01692340|P2|Participant Flow|Isotopically Labeled Phytoene|"3.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
165190|NCT01692340|P1|Participant Flow|Isotopically Labeled Lycopene|"10.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
165191|NCT01692340|O3|Outcome|Isotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
165731|NCT01691248|O2|Outcome|Placebo|Placebo tablet once daily for no longer than 40 days
165193|NCT01692340|O1|Outcome|Isotopically Labeled Lycopene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
165194|NCT01692340|O2|Outcome|Isotopically Labeled Phytoene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
165195|NCT01692340|O1|Outcome|Isotopically Labeled Lycopene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
165196|NCT01692340|O2|Outcome|Isotopically Labeled Phytoene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
165197|NCT01692340|O1|Outcome|Isotopically Labeled Lycopene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
165198|NCT01692340|O3|Outcome|Isotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
165199|NCT01692340|O2|Outcome|Isotopically Labeled Phytoene|"3.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
165200|NCT01692340|O1|Outcome|Isotopically Labeled Lycopene|"10.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
165201|NCT01692340|E3|Reported Event|Isotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
165202|NCT01692340|E2|Reported Event|Isotopically Labeled Phytoene|"3.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
165203|NCT01692340|E1|Reported Event|Isotopically Labeled Lycopene|"10.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
165204|NCT01692301|B3|Baseline|Total|Total of all reporting groups
165205|NCT01692301|B2|Baseline|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
165206|NCT01692301|B1|Baseline|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
165207|NCT01692301|P2|Participant Flow|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
165208|NCT01692301|P1|Participant Flow|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
165209|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
165210|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
165211|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
165212|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
165496|NCT01691560|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
165213|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
165214|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
165215|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
165216|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
165217|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
165218|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
165219|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
165220|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
165221|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
165222|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
165223|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
165224|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
165225|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
165497|NCT01691560|O4|Outcome|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
165226|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
165227|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
165228|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
165229|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
165230|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
165231|NCT01692301|E2|Reported Event|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
165232|NCT01692301|E1|Reported Event|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
165233|NCT01691898|B7|Baseline|Total|Total of all reporting groups
165234|NCT01691898|B6|Baseline|Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165235|NCT01691898|B5|Baseline|Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165236|NCT01691898|B4|Baseline|Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r FL and DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165237|NCT01691898|B3|Baseline|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
165238|NCT01691898|B2|Baseline|Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165498|NCT01691560|O3|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
165499|NCT01691560|O2|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
183847|NCT01627002|O4|Outcome|Part B PA401 3.0 mg|
165239|NCT01691898|B1|Baseline|Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with relapsed or refractory [r/r] FL and DLBCL received rituximab (RTX) at a dose of 375 milligrams per square meter (mg/m^2) administered via intravenous (IV) infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 milligrams per kilogram (mg/kg) administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed disease progression (PD) were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165240|NCT01691898|P6|Participant Flow|Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165241|NCT01691898|P5|Participant Flow|Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165242|NCT01691898|P4|Participant Flow|Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r FL and DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165243|NCT01691898|P3|Participant Flow|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
165244|NCT01691898|P2|Participant Flow|Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165245|NCT01691898|P1|Participant Flow|Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with relapsed or refractory (r/r) follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) received rituximab (RTX) at a dose of 375 milligrams per square meter (mg/m^2) administered via intravenous (IV) infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 milligrams per kilogram (mg/kg) administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed disease progression (PD) were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165246|NCT01691898|O2|Outcome|Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165247|NCT01691898|O1|Outcome|Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165248|NCT01691898|O2|Outcome|Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165249|NCT01691898|O1|Outcome|Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165732|NCT01691248|O1|Outcome|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
165250|NCT01691898|O2|Outcome|Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165251|NCT01691898|O1|Outcome|Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165252|NCT01691898|O2|Outcome|Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165253|NCT01691898|O1|Outcome|Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165254|NCT01691898|O2|Outcome|Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165255|NCT01691898|O1|Outcome|Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165256|NCT01691898|O2|Outcome|Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165257|NCT01691898|O1|Outcome|Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165258|NCT01691898|O2|Outcome|Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165259|NCT01691898|O1|Outcome|Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165260|NCT01691898|O1|Outcome|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
165261|NCT01691898|O1|Outcome|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
165262|NCT01691898|O1|Outcome|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
165733|NCT01691248|O2|Outcome|Placebo|Placebo tablet once daily for no longer than 40 days
165263|NCT01691898|O1|Outcome|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
165264|NCT01691898|O1|Outcome|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
165265|NCT01691898|O1|Outcome|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
165266|NCT01691898|O2|Outcome|Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165267|NCT01691898|O1|Outcome|Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165268|NCT01691898|O2|Outcome|Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165269|NCT01691898|O1|Outcome|Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165270|NCT01691898|O2|Outcome|Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165271|NCT01691898|O1|Outcome|Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165272|NCT01691898|O2|Outcome|Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165734|NCT01691248|O1|Outcome|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
165273|NCT01691898|O1|Outcome|Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165274|NCT01691898|O2|Outcome|Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165275|NCT01691898|O1|Outcome|Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165276|NCT01691898|O2|Outcome|Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165277|NCT01691898|O1|Outcome|Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165278|NCT01691898|O2|Outcome|Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165279|NCT01691898|O1|Outcome|Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165280|NCT01691898|O2|Outcome|Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165281|NCT01691898|O1|Outcome|Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165634|NCT01691430|O1|Outcome|2 Cranberry Capsules|"Experimental: 2 cranberry capsules~2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
165282|NCT01691898|O2|Outcome|Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165283|NCT01691898|O1|Outcome|Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165284|NCT01691898|O2|Outcome|Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165285|NCT01691898|O1|Outcome|Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165286|NCT01691898|O2|Outcome|Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165287|NCT01691898|O1|Outcome|Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165288|NCT01691898|O2|Outcome|Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165289|NCT01691898|O1|Outcome|Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165290|NCT01691898|O5|Outcome|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
165402|NCT01691859|O1|Outcome|Mepolizumab 100 mg|Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
183848|NCT01627002|O3|Outcome|Part B PA401 1.0 mg|
165291|NCT01691898|O4|Outcome|Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165292|NCT01691898|O3|Outcome|Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165293|NCT01691898|O2|Outcome|Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165294|NCT01691898|O1|Outcome|Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165295|NCT01691898|O5|Outcome|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
165296|NCT01691898|O4|Outcome|Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165297|NCT01691898|O3|Outcome|Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165298|NCT01691898|O2|Outcome|Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165299|NCT01691898|O1|Outcome|Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165403|NCT01691859|O1|Outcome|Mepolizumab 100 mg|Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
183849|NCT01627002|O2|Outcome|Part A PA401 3.0 mg|
165300|NCT01691898|O5|Outcome|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
165301|NCT01691898|O4|Outcome|Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165302|NCT01691898|O3|Outcome|Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165303|NCT01691898|O2|Outcome|Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165304|NCT01691898|O1|Outcome|Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165305|NCT01691898|O5|Outcome|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
165306|NCT01691898|O4|Outcome|Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165307|NCT01691898|O3|Outcome|Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165308|NCT01691898|O2|Outcome|Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165320|NCT01691898|O1|Outcome|Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165448|NCT01691690|B3|Baseline|Total|Total of all reporting groups
165309|NCT01691898|O1|Outcome|Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165310|NCT01691898|O5|Outcome|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
165311|NCT01691898|O4|Outcome|Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165312|NCT01691898|O3|Outcome|Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165313|NCT01691898|O2|Outcome|Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165314|NCT01691898|O1|Outcome|Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165315|NCT01691898|O4|Outcome|Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165316|NCT01691898|O3|Outcome|Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165317|NCT01691898|O2|Outcome|Cohort E (FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165318|NCT01691898|O1|Outcome|Cohort E (DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165319|NCT01691898|O2|Outcome|Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165487|NCT01691560|O2|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
165321|NCT01691898|O2|Outcome|Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165322|NCT01691898|O1|Outcome|Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165323|NCT01691898|O2|Outcome|Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165324|NCT01691898|O1|Outcome|Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165325|NCT01691898|O2|Outcome|Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165326|NCT01691898|O1|Outcome|Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165327|NCT01691898|O4|Outcome|Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165328|NCT01691898|O3|Outcome|Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165329|NCT01691898|O2|Outcome|Cohort E (FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165330|NCT01691898|O1|Outcome|Cohort E (DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165331|NCT01691898|O4|Outcome|Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165332|NCT01691898|O3|Outcome|Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165333|NCT01691898|O2|Outcome|Cohort E (FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165488|NCT01691560|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
165334|NCT01691898|O1|Outcome|Cohort E (DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165335|NCT01691898|O4|Outcome|Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165336|NCT01691898|O3|Outcome|Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165337|NCT01691898|O2|Outcome|Cohort E (FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165338|NCT01691898|O1|Outcome|Cohort E (DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165339|NCT01691898|O5|Outcome|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
165340|NCT01691898|O4|Outcome|Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165341|NCT01691898|O3|Outcome|Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165342|NCT01691898|O2|Outcome|Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165343|NCT01691898|O1|Outcome|Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165344|NCT01691898|O5|Outcome|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
165400|NCT01691859|O1|Outcome|Mepolizumab 100 mg|Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
165345|NCT01691898|O4|Outcome|Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165346|NCT01691898|O3|Outcome|Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165347|NCT01691898|O2|Outcome|Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165348|NCT01691898|O1|Outcome|Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165349|NCT01691898|O5|Outcome|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
165350|NCT01691898|O4|Outcome|Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165351|NCT01691898|O3|Outcome|Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165352|NCT01691898|O2|Outcome|Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165353|NCT01691898|O1|Outcome|Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165401|NCT01691859|O1|Outcome|Mepolizumab 100 mg|Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
183850|NCT01627002|O1|Outcome|Part A PA401 1.0 mg|
165354|NCT01691898|O5|Outcome|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
165355|NCT01691898|O4|Outcome|Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165356|NCT01691898|O3|Outcome|Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165357|NCT01691898|O2|Outcome|Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165358|NCT01691898|O1|Outcome|Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165359|NCT01691898|O3|Outcome|Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165360|NCT01691898|O2|Outcome|Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165361|NCT01691898|O1|Outcome|Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r FL and DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165362|NCT01691898|O6|Outcome|Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165363|NCT01691898|O5|Outcome|Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165364|NCT01691898|O4|Outcome|Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r FL and DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165489|NCT01691560|O4|Outcome|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
165365|NCT01691898|O3|Outcome|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
165366|NCT01691898|O2|Outcome|Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165367|NCT01691898|O1|Outcome|Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165368|NCT01691898|O2|Outcome|Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165369|NCT01691898|O1|Outcome|Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165370|NCT01691898|O4|Outcome|Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165371|NCT01691898|O3|Outcome|Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165372|NCT01691898|O2|Outcome|Cohort E (FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165373|NCT01691898|O1|Outcome|Cohort E (DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165374|NCT01691898|O5|Outcome|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
165375|NCT01691898|O4|Outcome|Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
183851|NCT01627002|O4|Outcome|Part B PA401 3.0 mg|
165376|NCT01691898|O3|Outcome|Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165377|NCT01691898|O2|Outcome|Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165378|NCT01691898|O1|Outcome|Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165379|NCT01691898|O5|Outcome|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
165380|NCT01691898|O4|Outcome|Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165381|NCT01691898|O3|Outcome|Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165382|NCT01691898|O2|Outcome|Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165383|NCT01691898|O1|Outcome|Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165384|NCT01691898|E6|Reported Event|Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165385|NCT01691898|E5|Reported Event|Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab|Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165490|NCT01691560|O3|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
165386|NCT01691898|E4|Reported Event|Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab|Participants with r/r FL and DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
165387|NCT01691898|E3|Reported Event|Cohort C (FL): RTX + Polatuzumab|Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
165388|NCT01691898|E2|Reported Event|Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab|Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165389|NCT01691898|E1|Reported Event|Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab|Participants with relapsed or refractory [r/r] FL and DLBCL received rituximab (RTX) at a dose of 375 milligrams per square meter (mg/m^2) administered via intravenous (IV) infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 milligrams per kilogram (mg/kg) administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed disease progression (PD) were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
165390|NCT01691885|B1|Baseline|Per Protocol Population|All participants received placebo or FF/VI 100/25 µg in either of the two treatment periods QD, each morning from a DPI. Treatment periods lasted 7 days up to a maximum of 14 days for each period. The two treatments were separated by a wash out period of 7 days, up to a maximum of 9 days.
165391|NCT01691885|P2|Participant Flow|FF/VI Then Placebo|Participants entering Treatment Period 1 received FF/VI 100/25 µg QD, each morning via a DPI for a period of 7 days, up to a maximum of 14 days. Following Treatment Period 1, participants entered a washout period for 7 days, up to a maximum of 9 days. Following the washout period, participants entered Treatment Period 2 and received matching placebo QD, each morning via a DPI for 7 days, up to a maximum of 14 days.
165392|NCT01691885|P1|Participant Flow|Placebo Then FF/VI|Participants entering Treatment Period 1 received matching placebo once daily (QD), each morning via a dry powder inhaler (DPI) for a period of 7 days, up to a maximum of 14 days. Following Treatment Period 1, participants entered a washout period for 7 days, up to a maximum of 9 days. Following the washout period participants entered Treatment Period 2 and received Fluticasone Furoate/Vilanerol (FF/VI) 100/25 micrograms (µg), QD, each morning via a DPI for 7 days, up to a maximum of 14 days.
165393|NCT01691885|O2|Outcome|FF/VI|Participants received FF/VI 100/25 μg QD, each morning via a DPI for a period of 7 days, up to a maximum of 14 days during one of the two Treatment Periods. Participants that received FF/VI 100/25 μg in Treatment Period 1, crossed over after the washout period to receive placebo during Treatment Period 2. Participants that received placebo during Treatment Period 1, crossed over after the washout period to receive FF/VI 100/25 μg during Treatment Period 2.
165394|NCT01691885|O1|Outcome|Placebo|Participants received matching placebo once daily (QD), each morning via a dry powder inhaler (DPI) for a period of 7 days, up to a maximum of 14 days during one of the two Treatment Periods. Participants that received placebo in Treatment Period 1, crossed over after the washout period to receive FF/VI 100/25 μg during Treatment Period 2. Participants that received FF/VI 100/25 μg during Treatment Period 1, crossed over after the washout period to receive placebo during Treatment Period 2.
165395|NCT01691885|E2|Reported Event|FF/VI|Participants received FF/VI 100/25 μg QD, each morning via a DPI for a period of 7 days, up to a maximum of 14 days during one of the two Treatment Periods. Participants that received FF/VI 100/25 μg in Treatment Period 1, crossed over after the washout period to receive placebo during Treatment Period 2. Participants that received placebo during Treatment Period 1, crossed over after the washout period to receive FF/VI 100/25 μg during Treatment Period 2.
165396|NCT01691885|E1|Reported Event|Placebo|Participants received matching placebo once daily (QD), each morning via a dry powder inhaler (DPI) for a period of 7 days, up to a maximum of 14 days during one of the two Treatment Periods. Participants that received placebo in Treatment Period 1, crossed over after the washout period to receive FF/VI 100/25 μg during Treatment Period 2. Participants that received FF/VI 100/25 μg during Treatment Period 1, crossed over after the washout period to receive placebo during Treatment Period 2.
165397|NCT01691859|B1|Baseline|Mepolizumab 100 mg|Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
165398|NCT01691859|P1|Participant Flow|Mepolizumab 100 mg|Participants received 100 milligram (mg) of mepolizumab injected subcutaneously (SC) once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
165399|NCT01691859|O1|Outcome|Mepolizumab 100 mg|Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
165404|NCT01691859|O1|Outcome|Mepolizumab 100 mg|Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
165405|NCT01691859|O1|Outcome|Mepolizumab 100 mg|Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
165406|NCT01691859|O1|Outcome|Mepolizumab 100 mg|Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
165407|NCT01691859|O1|Outcome|Mepolizumab 100 mg|Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
165408|NCT01691859|O1|Outcome|Mepolizumab 100 mg|Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
165409|NCT01691859|O1|Outcome|Mepolizumab 100 mg|Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
165410|NCT01691859|O1|Outcome|Mepolizumab 100 mg|Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
165411|NCT01691859|O1|Outcome|Mepolizumab 100 mg|Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
165412|NCT01691859|O1|Outcome|Mepolizumab 100 mg|Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
165413|NCT01691859|O1|Outcome|Mepolizumab 100 mg|Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
165414|NCT01691859|O1|Outcome|Mepolizumab 100 mg|Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
165415|NCT01691859|E1|Reported Event|Mepolizumab|Subjects will receive 100 mg of mepolizumab (in 1ml polypropylene syringe) injected subcutaneously (SC) approximately every 4 weeks.
165416|NCT01691794|B4|Baseline|Total|Total of all reporting groups
165417|NCT01691794|B3|Baseline|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
165418|NCT01691794|B2|Baseline|Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
165419|NCT01691794|B1|Baseline|Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir in capsule formation plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
165420|NCT01691794|P3|Participant Flow|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
165421|NCT01691794|P2|Participant Flow|Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
165422|NCT01691794|P1|Participant Flow|Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir in capsule formation plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
165491|NCT01691560|O2|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
165676|NCT01691339|O4|Outcome|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
165423|NCT01691794|O3|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
165424|NCT01691794|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
165425|NCT01691794|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir in capsule formation plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
165426|NCT01691794|O3|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
165427|NCT01691794|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
165428|NCT01691794|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir in capsule formation plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
165429|NCT01691794|O3|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
165430|NCT01691794|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
165431|NCT01691794|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir in capsule formation plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
165432|NCT01691794|E3|Reported Event|B/L Weight Greater Than and Equal 40 kg|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
165433|NCT01691794|E2|Reported Event|B/L Weight 20 to Less Than 40 kg|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
165434|NCT01691794|E1|Reported Event|B/L Weight 15 to Less Than 20 kg|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir in capsule formation plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years.
165435|NCT01691781|B3|Baseline|Total|Total of all reporting groups
165436|NCT01691781|B2|Baseline|Normals|Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
165437|NCT01691781|B1|Baseline|Primary Hyperparathyroidism|Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.
165438|NCT01691781|P2|Participant Flow|Normal|Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
165439|NCT01691781|P1|Participant Flow|Primary Hyperparathyroidism|Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.
165440|NCT01691781|O2|Outcome|Normal|Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
165441|NCT01691781|O1|Outcome|Primary Hyperparathyroidism|Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.
165442|NCT01691781|O2|Outcome|Normal|Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
165443|NCT01691781|O1|Outcome|Primary Hyperparathyroidism|Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.
165444|NCT01691781|O2|Outcome|Normal|Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
165445|NCT01691781|O1|Outcome|Primary Hyperparathyroidism|Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.
165446|NCT01691781|E2|Reported Event|Normal|Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
165447|NCT01691781|E1|Reported Event|Primary Hyperparathyroidism|Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.
165449|NCT01691690|B2|Baseline|Saline Placebo|"Patients will receive pre-medication with oral midazolam. Participants of this control arm will receive saline to establish a control model for evaluating opioid-sparing effect and pain score reduction compared to the intervention arm.~Sodium Chloride (saline): 0.9% Sodium Chloride Placebo will be infused intraoperatively over 15 minutes to establish a control model while evaluating the pain score differences in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
165450|NCT01691690|B1|Baseline|IV Acetaminophen|"Patients will receive pre-medication with oral midazolam. Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction.~Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg) will be infused intraoperatively over 15 minutes to evaluate the opioid-sparing effect and pain score reduction in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
165451|NCT01691690|P2|Participant Flow|Saline Placebo|"Patients will receive pre-medication with oral midazolam. Participants of this control arm will receive saline to establish a control model for evaluating opioid-sparing effect and pain score reduction compared to the intervention arm.~Sodium Chloride (saline): 0.9% Sodium Chloride Placebo will be infused intraoperatively over 15 minutes to establish a control model while evaluating the pain score differences in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
165452|NCT01691690|P1|Participant Flow|IV Acetaminophen|"Patients will receive pre-medication with oral midazolam. Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction.~Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg) will be infused intraoperatively over 15 minutes to evaluate the opioid-sparing effect and pain score reduction in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
165453|NCT01691690|O2|Outcome|Saline Placebo Infused Intraoperatively|"For this arm Morphine will be administered to manage pain.~Normal Saline Flush: Saline placebo will be infused intraoperatively.~Midazolam: Midazolam (0.5mg/kg to maximum dose of 20mg) given 15-20 minutes before induction.~Sevoflurane: Sevoflurane for anesthesia induction.~Nitrous Oxide/Oxygen: Combination of NO2 & O2 for anesthesia induction.~Propofol: Propofol 1-1.5 mg/kg to facilitate endotracheal intubation.~Morphine: Morphine 0.1 mg/kg given prior to intubation.~Ondansetron: Ondansetron (0.15 mg/kg, maximum dose of 4 mg) for postoperative nausea prophylaxis.~Dexamethasone: Dexamethasone (0.25 mg/kg, maximum dose of 20 mg) for postoperative nausea prophylaxis."
165454|NCT01691690|O1|Outcome|IV Acetaminophen|"Patients will receive pre-medication with oral midazolam Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction..~Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg).~Midazolam: Midazolam (0.5mg/kg to maximum dose of 20mg) given 15-20 minutes before induction.~Sevoflurane: Sevoflurane for anesthesia induction.~Nitrous Oxide/Oxygen: Combination of NO2 & O2 for anesthesia induction.~Propofol: Propofol 1-1.5 mg/kg to facilitate endotracheal intubation.~Morphine: Morphine 0.1 mg/kg given prior to intubation.~Ondansetron: Ondansetron (0.15 mg/kg, maximum dose of 4 mg) for postoperative nausea prophylaxis.~Dexamethasone: Dexamethasone (0.25 mg/kg, maximum dose of 20 mg) for postoperative nausea prophylaxis."
165455|NCT01691690|O2|Outcome|Saline Placebo Infused Intraoperatively|"Patients will receive pre-medication with oral midazolam. Participants of this control arm will receive saline to establish a control model for evaluating opioid-sparing effect and pain score reduction compared to the intervention arm.~Sodium Chloride (saline): 0.9% Sodium Chloride Placebo will be infused intraoperatively over 15 minutes to establish a control model while evaluating the pain score differences in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
165456|NCT01691690|O1|Outcome|IV Acetaminophen|"Patients will receive pre-medication with oral midazolam. Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction.~Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg) will be infused intraoperatively over 15 minutes to evaluate the opioid-sparing effect and pain score reduction in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
165457|NCT01691690|O2|Outcome|Saline Placebo|"Patients will receive pre-medication with oral midazolam. Participants of this control arm will receive saline to establish a control model for evaluating opioid-sparing effect and pain score reduction compared to the intervention arm.~Sodium Chloride (saline): 0.9% Sodium Chloride Placebo will be infused intraoperatively over 15 minutes to establish a control model while evaluating the pain score differences in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
165458|NCT01691690|O1|Outcome|IV Acetaminophen|"Patients will receive pre-medication with oral midazolam. Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction.~Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg) will be infused intraoperatively over 15 minutes to evaluate the opioid-sparing effect and pain score reduction in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
165459|NCT01691690|E2|Reported Event|Saline Placebo|"Patients will receive pre-medication with oral midazolam. Participants of this control arm will receive saline to establish a control model for evaluating opioid-sparing effect and pain score reduction compared to the intervention arm.~Sodium Chloride (saline): 0.9% Sodium Chloride Placebo will be infused intraoperatively over 15 minutes to establish a control model while evaluating the pain score differences in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
165492|NCT01691560|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
165493|NCT01691560|O4|Outcome|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
165494|NCT01691560|O3|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
165460|NCT01691690|E1|Reported Event|IV Acetaminophen|"Patients will receive pre-medication with oral midazolam. Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction.~Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg) will be infused intraoperatively over 15 minutes to evaluate the opioid-sparing effect and pain score reduction in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
165461|NCT01691612|B1|Baseline|D. Pteronyssinus Allergens|"Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments~installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later"
165462|NCT01691612|P1|Participant Flow|D. Pteronyssinus Allergens|"Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments~installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later"
165463|NCT01691612|O1|Outcome|D. Pteronyssinus Allergens|"Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments~installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later"
165464|NCT01691612|O1|Outcome|D. Pteronyssinus Allergens|"Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments~installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later"
165465|NCT01691612|O1|Outcome|D. Pteronyssinus Allergens|"Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments~installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later"
165466|NCT01691612|O1|Outcome|D. Pteronyssinus Allergens|"Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments~installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later"
165467|NCT01691612|E1|Reported Event|D. Pteronyssinus Allergens|"Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments~installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later"
165468|NCT01691560|B5|Baseline|Total|Total of all reporting groups
165469|NCT01691560|B4|Baseline|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
165470|NCT01691560|B3|Baseline|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
165471|NCT01691560|B2|Baseline|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
165472|NCT01691560|B1|Baseline|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
165473|NCT01691560|P4|Participant Flow|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
165474|NCT01691560|P3|Participant Flow|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
165475|NCT01691560|P2|Participant Flow|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
165476|NCT01691560|P1|Participant Flow|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 parts per million (ppm) fluoride as sodium monofluorophosphate
165477|NCT01691560|O4|Outcome|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
165478|NCT01691560|O3|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
165479|NCT01691560|O2|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
165480|NCT01691560|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
165481|NCT01691560|O4|Outcome|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
165482|NCT01691560|O3|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
165483|NCT01691560|O2|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
165484|NCT01691560|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
165485|NCT01691560|O4|Outcome|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
165486|NCT01691560|O3|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
165500|NCT01691560|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
165501|NCT01691560|E4|Reported Event|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
165502|NCT01691560|E3|Reported Event|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
165503|NCT01691560|E2|Reported Event|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
165504|NCT01691560|E1|Reported Event|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
165505|NCT01691534|B8|Baseline|Total|Total of all reporting groups
165506|NCT01691534|B7|Baseline|Rifafour|Rifafour on Days 1 to 14, dosed by weight
165507|NCT01691534|B6|Baseline|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
165508|NCT01691534|B5|Baseline|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
165509|NCT01691534|B4|Baseline|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165510|NCT01691534|B3|Baseline|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165511|NCT01691534|B2|Baseline|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
165512|NCT01691534|B1|Baseline|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165513|NCT01691534|P7|Participant Flow|Rifafour|Rifafour on Days 1 to 14, dosed by weight
165514|NCT01691534|P6|Participant Flow|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
165515|NCT01691534|P5|Participant Flow|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
165516|NCT01691534|P4|Participant Flow|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165517|NCT01691534|P3|Participant Flow|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165518|NCT01691534|P2|Participant Flow|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
165519|NCT01691534|P1|Participant Flow|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165520|NCT01691534|O7|Outcome|Rifafour|Rifafour on Days 1 to 14, dosed by weight
165521|NCT01691534|O6|Outcome|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
165522|NCT01691534|O5|Outcome|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
165523|NCT01691534|O4|Outcome|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165524|NCT01691534|O3|Outcome|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165525|NCT01691534|O2|Outcome|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
165526|NCT01691534|O1|Outcome|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165527|NCT01691534|O7|Outcome|Rifafour|Rifafour on Days 1 to 14, dosed by weight
165528|NCT01691534|O6|Outcome|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
165529|NCT01691534|O5|Outcome|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
165530|NCT01691534|O4|Outcome|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165531|NCT01691534|O3|Outcome|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165532|NCT01691534|O2|Outcome|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
165533|NCT01691534|O1|Outcome|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165534|NCT01691534|O7|Outcome|Rifafour|Rifafour on Days 1 to 14, dosed by weight
165535|NCT01691534|O6|Outcome|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-1414
165536|NCT01691534|O5|Outcome|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
165537|NCT01691534|O4|Outcome|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165538|NCT01691534|O3|Outcome|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165539|NCT01691534|O2|Outcome|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
165540|NCT01691534|O1|Outcome|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165541|NCT01691534|O7|Outcome|Rifafour|Rifafour on Days 1 to 14, dosed by weight
165542|NCT01691534|O6|Outcome|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
165543|NCT01691534|O5|Outcome|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
165544|NCT01691534|O4|Outcome|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165545|NCT01691534|O3|Outcome|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165546|NCT01691534|O2|Outcome|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
165547|NCT01691534|O1|Outcome|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165548|NCT01691534|O7|Outcome|Rifafour|Rifafour on Days 1 to 14, dosed by weight
165549|NCT01691534|O6|Outcome|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
165550|NCT01691534|O5|Outcome|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
165551|NCT01691534|O4|Outcome|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165552|NCT01691534|O3|Outcome|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165553|NCT01691534|O2|Outcome|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
165554|NCT01691534|O1|Outcome|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165555|NCT01691534|O7|Outcome|Rifafour|Rifafour on Days 1 to 14, dosed by weight
165556|NCT01691534|O6|Outcome|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
165557|NCT01691534|O5|Outcome|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
165558|NCT01691534|O4|Outcome|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165559|NCT01691534|O3|Outcome|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165560|NCT01691534|O2|Outcome|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
165561|NCT01691534|O1|Outcome|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165562|NCT01691534|E7|Reported Event|Rifafour|Rifafour on Days 1 to 14, dosed by weight
165563|NCT01691534|E6|Reported Event|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
165564|NCT01691534|E5|Reported Event|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
165565|NCT01691534|E4|Reported Event|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165566|NCT01691534|E3|Reported Event|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165567|NCT01691534|E2|Reported Event|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
165568|NCT01691534|E1|Reported Event|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
165569|NCT01691521|B4|Baseline|Total|Total of all reporting groups
165570|NCT01691521|B3|Baseline|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165571|NCT01691521|B2|Baseline|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165609|NCT01691508|E2|Reported Event|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165572|NCT01691521|B1|Baseline|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165573|NCT01691521|P3|Participant Flow|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165574|NCT01691521|P2|Participant Flow|Mepolizumab 75 mg IV|Participants received mepolizumab 75 milligrams (mg) IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165575|NCT01691521|P1|Participant Flow|Placebo|Participants received placebo intravenously (IV) plus placebo subcutaneously (SC) every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165576|NCT01691521|O3|Outcome|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study
165577|NCT01691521|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165578|NCT01691521|O1|Outcome|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165579|NCT01691521|O3|Outcome|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study
165580|NCT01691521|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165581|NCT01691521|O1|Outcome|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165582|NCT01691521|O3|Outcome|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study
165583|NCT01691521|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165584|NCT01691521|O1|Outcome|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165585|NCT01691521|O3|Outcome|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study
165586|NCT01691521|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165587|NCT01691521|O1|Outcome|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165588|NCT01691521|O3|Outcome|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165589|NCT01691521|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165590|NCT01691521|O1|Outcome|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165591|NCT01691521|E3|Reported Event|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study
165592|NCT01691521|E2|Reported Event|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165593|NCT01691521|E1|Reported Event|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165594|NCT01691508|B3|Baseline|Total|Total of all reporting groups
165595|NCT01691508|B2|Baseline|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165596|NCT01691508|B1|Baseline|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165597|NCT01691508|P2|Participant Flow|Mepolizumab 100mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165598|NCT01691508|P1|Participant Flow|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165599|NCT01691508|O2|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165600|NCT01691508|O1|Outcome|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165601|NCT01691508|O2|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165602|NCT01691508|O1|Outcome|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165603|NCT01691508|O2|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165604|NCT01691508|O1|Outcome|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165605|NCT01691508|O2|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165606|NCT01691508|O1|Outcome|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165607|NCT01691508|O2|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165608|NCT01691508|O1|Outcome|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165610|NCT01691508|E1|Reported Event|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
165611|NCT01691482|B1|Baseline|All Randomized Participants|All participants randomized to receive a sequence of either salbutamol (4 puffs; 100 µg per puff) via an MDI and albuterol (4 puffs; 90 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in TP1 and the same dose of each bronchodilator given in the opposite order in TP2, or ipratropium followed by albuterol/salbutamol in TP1 and the same dose of each bronchodilator given in the opposite order in TP2
165612|NCT01691482|P2|Participant Flow|Ipratropium Then A/S in TP1; A/S Then Ipratropium in TP2|Participants received Ipratropium (4 puffs; 20 µg per puff) followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) (A/S) via a MDI in TP1, then A/S followed by ipratropium at the same doses via an MDI in TP2.
165613|NCT01691482|P1|Participant Flow|A/S Then Ipratropium in TP1; Ipratropium Then A/S in TP2|Participants received albuterol (4 puffs; 90 micrograms [µg] per puff)/salbutamol (A/S) (4 puffs; 100 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via a metered-dose inhaler (MDI) during treatment period 1 (TP1) then, ipratropium followed by A/S at the same doses via an MDI in treatment period 2 (TP2).
165614|NCT01691482|O2|Outcome|Ipratropium Followed by Albuterol/Salbutamol|All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
165615|NCT01691482|O1|Outcome|Albuterol/Salbutamol Followed by Ipratropium|All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
165616|NCT01691482|O2|Outcome|Ipratropium Followed by Albuterol/Salbutamol|All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
165617|NCT01691482|O1|Outcome|Albuterol/Salbutamol Followed by Ipratropium|All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
165618|NCT01691482|O2|Outcome|Ipratropium Followed by Albuterol/Salbutamol|All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
165619|NCT01691482|O1|Outcome|Albuterol/Salbutamol Followed by Ipratropium|All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
165620|NCT01691482|O2|Outcome|Ipratropium Follwed by Albuterol/Salbutamol|All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
165621|NCT01691482|O1|Outcome|Albuterol/Salbutamol Followed by Ipratropium|All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
165622|NCT01691482|O2|Outcome|Ipratropium Follwed by Albuterol/Salbutamol|All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
165623|NCT01691482|O1|Outcome|Albuterol/Salbutamol Followed by Ipratropium|All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
165624|NCT01691482|O1|Outcome|All Randomized Participants|All participants randomized to receive a sequence of either salbutamol (4 puffs; 100 µg per puff) via an MDI and albuterol (4 puffs; 90 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in TP1 and the same dose of each bronchodilator given in the opposite order in TP2, or ipratropium followed by albuterol/salbutamol in TP1 and the same dose of each bronchodilator given in the opposite order in TP2
165625|NCT01691482|O2|Outcome|Ipratropium Followed by Albuterol/Salbutamol|All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
165626|NCT01691482|O1|Outcome|Albuterol/Salbutamol Followed by Ipratropium|All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
165627|NCT01691482|E1|Reported Event|All Randomized Participants|All participants randomized to receive a sequence of either salbutamol (4 puffs; 100 µg per puff) via an MDI and albuterol (4 puffs; 90 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in TP1 and the same dose of each bronchodilator given in the opposite order in TP2, or ipratropium followed by albuterol/salbutamol in TP1 and the same dose of each bronchodilator given in the opposite order in TP2
165628|NCT01691430|B3|Baseline|Total|Total of all reporting groups
165629|NCT01691430|B2|Baseline|2 Placebo Capsules|"Experimental: 2 placebo capsules qd~Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
165630|NCT01691430|B1|Baseline|2 Cranberry Capsules|"Experimental: 2 cranberry capsules~2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
165631|NCT01691430|P2|Participant Flow|2 Placebo Capsules|"Experimental: 2 placebo capsules qd~Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
165632|NCT01691430|P1|Participant Flow|2 Cranberry Capsules|"Experimental: 2 cranberry capsules~2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
165633|NCT01691430|O2|Outcome|2 Placebo Capsules|"Experimental: 2 placebo capsules qd~Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
165677|NCT01691339|O3|Outcome|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
165635|NCT01691430|O2|Outcome|2 Placebo Capsules|"Experimental: 2 placebo capsules qd~Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
165636|NCT01691430|O1|Outcome|2 Cranberry Capsules|"Experimental: 2 cranberry capsules~2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
165637|NCT01691430|O2|Outcome|2 Placebo Capsules|"Experimental: 2 placebo capsules qd~Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
165638|NCT01691430|O1|Outcome|2 Cranberry Capsules|"Experimental: 2 cranberry capsules~2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
165639|NCT01691430|O2|Outcome|2 Placebo Capsules|"Experimental: 2 placebo capsules qd~Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
165640|NCT01691430|O1|Outcome|2 Cranberry Capsules|"Experimental: 2 cranberry capsules~2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
165641|NCT01691430|O2|Outcome|2 Placebo Capsules|"Experimental: 2 placebo capsules qd~Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
165642|NCT01691430|O1|Outcome|2 Cranberry Capsules|"Experimental: 2 cranberry capsules~2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
165643|NCT01691430|O2|Outcome|2 Placebo Capsules|"Experimental: 2 placebo capsules qd~Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
165644|NCT01691430|O1|Outcome|2 Cranberry Capsules|"Experimental: 2 cranberry capsules~2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
165645|NCT01691430|O2|Outcome|2 Placebo Capsules|"Experimental: 2 placebo capsules qd~Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
165646|NCT01691430|O1|Outcome|2 Cranberry Capsules|"Experimental: 2 cranberry capsules~2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
165647|NCT01691430|O2|Outcome|2 Placebo Capsules|"Experimental: 2 placebo capsules qd~Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
165648|NCT01691430|O1|Outcome|2 Cranberry Capsules|"Experimental: 2 cranberry capsules~2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
165649|NCT01691430|O2|Outcome|2 Placebo Capsules|"Experimental: 2 placebo capsules qd~Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
165650|NCT01691430|O1|Outcome|2 Cranberry Capsules|"Experimental: 2 cranberry capsules~2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
165651|NCT01691430|O2|Outcome|2 Placebo Capsules|"Experimental: 2 placebo capsules qd~Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
165652|NCT01691430|O1|Outcome|2 Cranberry Capsules|"Experimental: 2 cranberry capsules~2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
165653|NCT01691430|E2|Reported Event|2 Placebo Capsules|"Experimental: 2 placebo capsules qd~Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
165654|NCT01691430|E1|Reported Event|2 Cranberry Capsules|"Experimental: 2 cranberry capsules~2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)"
165655|NCT01691339|B5|Baseline|Total|Total of all reporting groups
165656|NCT01691339|B4|Baseline|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
165657|NCT01691339|B3|Baseline|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
165658|NCT01691339|B2|Baseline|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
165659|NCT01691339|B1|Baseline|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
165660|NCT01691339|P4|Participant Flow|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
165661|NCT01691339|P3|Participant Flow|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
165662|NCT01691339|P2|Participant Flow|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
165663|NCT01691339|P1|Participant Flow|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
165664|NCT01691339|O4|Outcome|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
165665|NCT01691339|O3|Outcome|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
165666|NCT01691339|O2|Outcome|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
165667|NCT01691339|O1|Outcome|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
165668|NCT01691339|O4|Outcome|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
165669|NCT01691339|O3|Outcome|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
165670|NCT01691339|O2|Outcome|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
165671|NCT01691339|O1|Outcome|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
165672|NCT01691339|O4|Outcome|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
165673|NCT01691339|O3|Outcome|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
165674|NCT01691339|O2|Outcome|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
165675|NCT01691339|O1|Outcome|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
165678|NCT01691339|O2|Outcome|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
165679|NCT01691339|O1|Outcome|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
165680|NCT01691339|O4|Outcome|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
165681|NCT01691339|O3|Outcome|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
165682|NCT01691339|O2|Outcome|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
165683|NCT01691339|O1|Outcome|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
165684|NCT01691339|E4|Reported Event|Fluzone High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
165685|NCT01691339|E3|Reported Event|Fluzone Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
165686|NCT01691339|E2|Reported Event|Fluzone Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
165687|NCT01691339|E1|Reported Event|Fluzone Vaccine (Group 1)|'Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly'
165688|NCT01691326|B3|Baseline|Total|Total of all reporting groups
165689|NCT01691326|B2|Baseline|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
165690|NCT01691326|B1|Baseline|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
165691|NCT01691326|P2|Participant Flow|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses 0.5 mL of Fluzone vaccine
165692|NCT01691326|P1|Participant Flow|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
165693|NCT01691326|O2|Outcome|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
165694|NCT01691326|O1|Outcome|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
165695|NCT01691326|O2|Outcome|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
165696|NCT01691326|O1|Outcome|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
165697|NCT01691326|O2|Outcome|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
165698|NCT01691326|O1|Outcome|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
165699|NCT01691326|O2|Outcome|3 to < 9 Years Age Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
165700|NCT01691326|O1|Outcome|6 to < 36 Months Age Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
165701|NCT01691326|O2|Outcome|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
165702|NCT01691326|O1|Outcome|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
165703|NCT01691326|E2|Reported Event|3 to < 9 Years Age Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
165704|NCT01691326|E1|Reported Event|6 to < 36 Months Age Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
165705|NCT01691313|B5|Baseline|Total|Total of all reporting groups
165706|NCT01691313|B4|Baseline|Vanoxerine 400mg|"vanoxerine oral capsule, 400mg~Vanoxerine: single oral dose"
165707|NCT01691313|B3|Baseline|Vanoxerine 300mg|"vanoxerine oral capsule, 300mg~Vanoxerine: single oral dose"
165708|NCT01691313|B2|Baseline|Vanoxerine 200mg|"vanoxerine oral capsule, 200mg~Vanoxerine: single oral dose"
165709|NCT01691313|B1|Baseline|Placebo|"placebo to match vanoxerine oral capsule~Placebo: single oral dose"
165710|NCT01691313|P4|Participant Flow|Vanoxerine 400mg|vanoxerine 400 mg (4x100mg oral capsules) single oral dose
165711|NCT01691313|P3|Participant Flow|Vanoxerine 300mg|vanoxerine 300 mg (3x 100 mg oral capsules) single oral dose
165712|NCT01691313|P2|Participant Flow|Placebo|"placebo to match vanoxerine oral capsule~Placebo: single oral dose"
165713|NCT01691313|P1|Participant Flow|Vanoxerine 200mg|"vanoxerine 200 mg (2x 100mg oral capsules)~Vanoxerine: single oral dose"
165714|NCT01691313|O4|Outcome|Vanoxerine 400mg|"vanoxerine oral capsule, 400mg~Vanoxerine: single oral dose"
165715|NCT01691313|O3|Outcome|Vanoxerine 300mg|"vanoxerine oral capsule, 300mg~Vanoxerine: single oral dose"
165716|NCT01691313|O2|Outcome|Vanoxerine 200mg|"vanoxerine oral capsule, 200mg~Vanoxerine: single oral dose"
165717|NCT01691313|O1|Outcome|Placebo|"placebo to match vanoxerine oral capsule~Placebo: single oral dose"
165718|NCT01691313|O4|Outcome|Vanoxerine 400mg|"vanoxerine oral capsule, 400mg~Vanoxerine: single oral dose"
165719|NCT01691313|O3|Outcome|Vanoxerine 300mg|"vanoxerine oral capsule, 300mg~Vanoxerine: single oral dose"
165720|NCT01691313|O2|Outcome|Vanoxerine 200mg|"vanoxerine oral capsule, 200mg~Vanoxerine: single oral dose"
165721|NCT01691313|O1|Outcome|Placebo|"placebo to match vanoxerine oral capsule~Placebo: single oral dose"
165722|NCT01691313|E4|Reported Event|Vanoxerine 400mg|"vanoxerine oral capsule, 400mg~Vanoxerine: single oral dose"
165723|NCT01691313|E3|Reported Event|Vanoxerine 300mg|"vanoxerine oral capsule, 300mg~Vanoxerine: single oral dose"
165724|NCT01691313|E2|Reported Event|Vanoxerine 200mg|"vanoxerine oral capsule, 200mg~Vanoxerine: single oral dose"
165725|NCT01691313|E1|Reported Event|Placebo|"placebo to match vanoxerine oral capsule~Placebo: single oral dose"
165726|NCT01691248|B3|Baseline|Total|Total of all reporting groups
165727|NCT01691248|B2|Baseline|Placebo|Placebo tablet once daily for no longer than 40 days
165728|NCT01691248|B1|Baseline|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
165735|NCT01691248|O2|Outcome|Placebo|Placebo tablet once daily for no longer than 40 days
165736|NCT01691248|O1|Outcome|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
165737|NCT01691248|E2|Reported Event|Placebo|Placebo tablet once daily for no longer than 40 days
165738|NCT01691248|E1|Reported Event|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
165739|NCT01691092|B1|Baseline|Ketamine|"All subjects will receive ketamine~Ketamine: All subjects will receive ketamine to induce glutamate release in the brain"
165740|NCT01691092|P1|Participant Flow|Ketamine|"All subjects will receive ketamine~Ketamine: All subjects will receive ketamine to induce glutamate release in the brain"
165741|NCT01691092|O1|Outcome|Ketamine|"All subjects will receive ketamine~Ketamine: All subjects will receive ketamine to induce glutamate release in the brain"
165742|NCT01691092|E1|Reported Event|Ketamine|"All subjects will receive ketamine~Ketamine: All subjects will receive ketamine to induce glutamate release in the brain"
165743|NCT01691027|B1|Baseline|Crossover Design. All Subjects Undergo All Treatments.|Each participating subject will have three training modules on a tablet computer: scotoma awareness, line and curve tracing, and video games. The order of modules will be different for different groups of subjects. Training on a module will cease when the subject reaches a performance criterion. Retinal assessments will occur after each training module completion.
165744|NCT01691027|P1|Participant Flow|Visuo-motor Training for Low Vision|All participants undergo training on scotoma awareness, Line and Circle Tracing and Video games
165745|NCT01691027|O1|Outcome|SLO Measurements Pre and Post-training|"All subjects trained on two computer-based training modules. SLO assessment of changes in fine manual task performance and in retinal functional geography was done before training and after each training module~SLO measurements pre and post-training"
165746|NCT01691027|O1|Outcome|Visuo-motor Training|Participants undergo training on three modules, (1)scotoma awareness, (2) line and curve tracing, and (3) video games. SLO assessments of changes in fine manual task performance was measured by an improvement in mean maze tracing and printing score. Improvement in visuo-motor control was measured by stylus ellipse area and stylus-PRL distance before and after training.
165747|NCT01691027|E1|Reported Event|Subjects With Bilateral AMD, no Foveal Vision and 20/60 Vision|"Crossover design. All subjects undergo all treatments.~Practice tracing objects and printing with a stylus on a tablet computer: Subjects will have three training modules on a tablet computer: scotoma awareness, line and curve tracing, and video games. The order of modules will be different for different groups of subjects. Training on a module will cease when the subject reaches a performance criterion. Retinal assessments will occur after each training module completion."
165748|NCT01691014|B5|Baseline|Total|Total of all reporting groups
165749|NCT01691014|B4|Baseline|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165750|NCT01691014|B3|Baseline|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165751|NCT01691014|B2|Baseline|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165752|NCT01691014|B1|Baseline|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
165753|NCT01691014|P4|Participant Flow|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165754|NCT01691014|P3|Participant Flow|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165755|NCT01691014|P2|Participant Flow|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165756|NCT01691014|P1|Participant Flow|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
165757|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165758|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165759|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165760|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
165761|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165762|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165763|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165764|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
165765|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165766|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165767|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165768|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
165769|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165770|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165771|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165772|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
165773|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165774|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165775|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165776|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
165777|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165778|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165779|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165780|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
165781|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165782|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165783|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165784|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
165785|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165786|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165787|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165788|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
165789|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165790|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165791|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165792|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
165793|NCT01691014|E4|Reported Event|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165794|NCT01691014|E3|Reported Event|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165795|NCT01691014|E2|Reported Event|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
165796|NCT01691014|E1|Reported Event|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
165797|NCT01690988|B4|Baseline|Total|Total of all reporting groups
165798|NCT01690988|B3|Baseline|Ketamine (1 mg/kg)|"High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (1 mg/kg): High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
165799|NCT01690988|B2|Baseline|Normal Saline (Placebo)|"Intravenous normal saline~Normal Saline (placebo): Normal saline IV following induction of anesthesia or administration of sedative medications"
165800|NCT01690988|B1|Baseline|Ketamine (0.5 mg/kg)|"Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (0.5 mg/kg): Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
165801|NCT01690988|P3|Participant Flow|Ketamine (1 mg/kg)|"High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (1 mg/kg): High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
165802|NCT01690988|P2|Participant Flow|Normal Saline (Placebo)|"Intravenous normal saline~Normal Saline (placebo): Normal saline IV following induction of anesthesia or administration of sedative medications"
165803|NCT01690988|P1|Participant Flow|Ketamine (0.5 mg/kg)|"Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (0.5 mg/kg): Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
168112|NCT01683409|B4|Baseline|Baricitinib 1.5 mg/1 mg QD|Baricitinib 1.5 mg or 1 mg administered PO QD.
165804|NCT01690988|O3|Outcome|Ketamine (1 mg/kg)|"High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (1 mg/kg): High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
165805|NCT01690988|O2|Outcome|Normal Saline (Placebo)|"Intravenous normal saline~Normal Saline (placebo): Normal saline IV following induction of anesthesia or administration of sedative medications"
165806|NCT01690988|O1|Outcome|Ketamine (0.5 mg/kg)|"Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (0.5 mg/kg): Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
165807|NCT01690988|O3|Outcome|Ketamine (1 mg/kg)|"High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (1 mg/kg): High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
165808|NCT01690988|O2|Outcome|Normal Saline (Placebo)|"Intravenous normal saline~Normal Saline (placebo): Normal saline IV following induction of anesthesia or administration of sedative medications"
165809|NCT01690988|O1|Outcome|Ketamine (0.5 mg/kg)|"Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (0.5 mg/kg): Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
165810|NCT01690988|O3|Outcome|Ketamine (1 mg/kg)|"High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (1 mg/kg): High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
165811|NCT01690988|O2|Outcome|Normal Saline (Placebo)|"Intravenous normal saline~Normal Saline (placebo): Normal saline IV following induction of anesthesia or administration of sedative medications"
165812|NCT01690988|O1|Outcome|Ketamine (0.5 mg/kg)|"Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (0.5 mg/kg): Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
165813|NCT01690988|O3|Outcome|Ketamine (1 mg/kg)|"High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (1 mg/kg): High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
165814|NCT01690988|O2|Outcome|Normal Saline (Placebo)|"Intravenous normal saline~Normal Saline (placebo): Normal saline IV following induction of anesthesia or administration of sedative medications"
165815|NCT01690988|O1|Outcome|Ketamine (0.5 mg/kg)|"Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (0.5 mg/kg): Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
165816|NCT01690988|O3|Outcome|Ketamine (1 mg/kg)|"High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (1 mg/kg): High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
165817|NCT01690988|O2|Outcome|Normal Saline (Placebo)|"Intravenous normal saline~Normal Saline (placebo): Normal saline IV following induction of anesthesia or administration of sedative medications"
165818|NCT01690988|O1|Outcome|Ketamine (0.5 mg/kg)|"Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (0.5 mg/kg): Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
165819|NCT01690988|O3|Outcome|Ketamine (1 mg/kg)|"High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (1 mg/kg): High dose (sub-anesthetic) 1 mg/kg ketamine following induction anesthesia or administration of sedative medications."
165820|NCT01690988|O2|Outcome|Normal Saline (Placebo)|"Intravenous normal saline~Normal Saline (placebo): Normal saline IV following induction of anesthesia or administration of sedative medications"
165821|NCT01690988|O1|Outcome|Ketamine (0.5 mg/kg )|"Low dose ketamine (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (0.5 mg/kg): (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
165822|NCT01690988|O2|Outcome|Normal Saline (Placebo)|"Intravenous normal saline~Normal Saline (placebo): Normal saline IV following induction of anesthesia or administration of sedative medications"
165823|NCT01690988|O1|Outcome|Ketamine (0.5 mg/kg and 1 mg/kg)|"Both the 0.5 mg/kg and the 1mg/kg doses groups of Ketamine were combined for analysis)~Low dose Ketamine (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (1 mg/kg): (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
165824|NCT01690988|E3|Reported Event|Ketamine (1 mg/kg)|"High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (1 mg/kg): High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
165825|NCT01690988|E2|Reported Event|Normal Saline (Placebo)|"Intravenous normal saline~Normal Saline (placebo): Normal saline IV following induction of anesthesia or administration of sedative medications"
165826|NCT01690988|E1|Reported Event|Ketamine (0.5 mg/kg)|"Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications.~Ketamine (0.5 mg/kg): Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications."
165827|NCT01690923|B1|Baseline|Current CPAP Users|"Nasal mask; Pillows mask~Nasal mask : Nasal mask (Mirage Activa, Micro, FX)~Pillows mask : Nasal pillows mask (Swift FX)"
165828|NCT01690923|P2|Participant Flow|Pillows Mask First, Then Nasal Mask|"Sequence 2: Pillows mask first, then Nasal mask~[Nasal mask : Nasal mask (Mirage Activa, Micro, FX) Pillows mask : Nasal pillows mask (Swift FX)]"
165829|NCT01690923|P1|Participant Flow|Nasal Mask First, Then Pillows Mask|"Sequence 1: Nasal mask first, then Pillows mask~[Nasal mask : Nasal mask (Mirage Activa, Micro, FX) Pillows mask : Nasal pillows mask (Swift FX)]"
165830|NCT01690923|O1|Outcome|Current CPAP Users|"Nasal mask; Pillows mask~Nasal mask : Nasal mask (Mirage Activa, Micro, FX)~Pillows mask : Nasal pillows mask (Swift FX)"
183852|NCT01627002|O3|Outcome|Part B PA401 1.0 mg|
165831|NCT01690923|O1|Outcome|Current CPAP Users|"Nasal mask; Pillows mask~Nasal mask : Nasal mask (Mirage Activa, Micro, FX)~Pillows mask : Nasal pillows mask (Swift FX)"
165832|NCT01690923|E1|Reported Event|Current CPAP Users|"Nasal mask; Pillows mask~Nasal mask : Nasal mask (Mirage Activa, Micro, FX)~Pillows mask : Nasal pillows mask (Swift FX)"
165833|NCT01690663|B5|Baseline|Total|Total of all reporting groups
165834|NCT01690663|B4|Baseline|Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml|"Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml~Bupivacaine 0.25%~Dexamethasone"
165835|NCT01690663|B3|Baseline|Bupivacaine 0.25% Mixed With 2mg Dexamethasone|"Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
165836|NCT01690663|B2|Baseline|Bupivacaine 0.25% With 1mg Dexamethasone (1ml)|"Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
165837|NCT01690663|B1|Baseline|Bupivacaine 0.25% Mixed With 1ml Normal Saline|"Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)~Bupivacaine 0.25%~normal saline: placebo"
165838|NCT01690663|P4|Participant Flow|Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml|"Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml~Bupivacaine 0.25%~Dexamethasone"
165839|NCT01690663|P3|Participant Flow|Bupivacaine 0.25% Mixed With 2mg Dexamethasone|"Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
165840|NCT01690663|P2|Participant Flow|Bupivacaine 0.25% With 1mg Dexamethasone (1ml)|"Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
165841|NCT01690663|P1|Participant Flow|Bupivacaine 0.25% Mixed With 1ml Normal Saline|"Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)~Bupivacaine 0.25%~normal saline: placebo"
165842|NCT01690663|O4|Outcome|Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml|"Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml~Bupivacaine 0.25%~Dexamethasone"
165843|NCT01690663|O3|Outcome|Bupivacaine 0.25% Mixed With 2mg Dexamethasone|"Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
165844|NCT01690663|O2|Outcome|Bupivacaine 0.25% With 1mg Dexamethasone (1ml)|"Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
165845|NCT01690663|O1|Outcome|Bupivacaine 0.25% Mixed With 1ml Normal Saline|"Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)~Bupivacaine 0.25%~normal saline: placebo"
165846|NCT01690663|O4|Outcome|Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml|"Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml~Bupivacaine 0.25%~Dexamethasone"
165847|NCT01690663|O3|Outcome|Bupivacaine 0.25% Mixed With 2mg Dexamethasone|"Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
165848|NCT01690663|O2|Outcome|Bupivacaine 0.25% With 1mg Dexamethasone (1ml)|"Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
165849|NCT01690663|O1|Outcome|Bupivacaine 0.25% Mixed With 1ml Normal Saline|"Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)~Bupivacaine 0.25%~normal saline: placebo"
165850|NCT01690663|E4|Reported Event|Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml|"Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml~Bupivacaine 0.25%~Dexamethasone"
165851|NCT01690663|E3|Reported Event|Bupivacaine 0.25% Mixed With 2mg Dexamethasone|"Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
165852|NCT01690663|E2|Reported Event|Bupivacaine 0.25% With 1mg Dexamethasone (1ml)|"Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
165853|NCT01690663|E1|Reported Event|Bupivacaine 0.25% Mixed With 1ml Normal Saline|"Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)~Bupivacaine 0.25%~normal saline: placebo"
165854|NCT01690546|B1|Baseline|BUP/VLNXT to VIVITROL|
165855|NCT01690546|P1|Participant Flow|BUP/VLNXT to VIVITROL|
165856|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
165857|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
165858|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
165859|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
165860|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
165861|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
165862|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
165863|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
165864|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
165865|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
165866|NCT01690546|E1|Reported Event|BUP/VLNXT to VIVITROL|
165867|NCT01690299|B4|Baseline|Total|Total of all reporting groups
165868|NCT01690299|B3|Baseline|Etanercept Plus Placebo Tablet|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165869|NCT01690299|B2|Baseline|Apremilast Plus Placebo Injection|Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165870|NCT01690299|B1|Baseline|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165871|NCT01690299|P6|Participant Flow|Etanercept/Apremilast|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants discontinued etanercept and were switched to apremilast 30mg PO BID through week 104.
165872|NCT01690299|P5|Participant Flow|Apremilast/Apremilast|Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID only through week 104.
165873|NCT01690299|P4|Participant Flow|Placebo/Apremilast|Participants received identically matching placebo tablets by PO, BID and SC saline (placebo) injections (1mL x 2 injections SC) weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg apremilast PO BID and remained on this dose through week 104.
166050|NCT01689779|O2|Outcome|Sugar Pill|"40 patients will receive a sugar pill orally 3-7 days before surgery.~Placebo: sugar pill"
165874|NCT01690299|P3|Participant Flow|Etanercept Plus Placebo Tablet|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165875|NCT01690299|P2|Participant Flow|Apremilast Plus Placebo Injection|Participants received apremilast 30 mg PO BID plus 2-1ml placebo SC saline injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165876|NCT01690299|P1|Participant Flow|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165877|NCT01690299|O3|Outcome|Etanercept/Apremilast|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to apremilast 30mg PO BID through week 104.
165878|NCT01690299|O2|Outcome|Apremilast/Apremilast|Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID through week 104.
165879|NCT01690299|O1|Outcome|Placebo/Apremilast|Participants received identically matching placebo tablets by mouth (PO), twice a day (BID) and subcutaneous (SC) saline (placebo) injections (1mL x 2 injections SC) weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg Apremilast PO BID and remained on this dose through week 104.
165880|NCT01690299|O3|Outcome|Etanercept Plus Placebo Tablets|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165881|NCT01690299|O2|Outcome|Apremilast Plus Placebo Injection|Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165882|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165883|NCT01690299|O3|Outcome|Etanercept/Apremilast|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to apremilast 30mg PO BID through week 104.
165884|NCT01690299|O2|Outcome|Apremilast/Apremilast|Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID through week 104.
165885|NCT01690299|O1|Outcome|Placebo/Apremilast|Participants received identically matching placebo tablets PO BID and SC saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg Apremilast PO BID and remained on this dose through week 104.
165886|NCT01690299|O3|Outcome|Etanercept Plus Placebo Tablets|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165887|NCT01690299|O2|Outcome|Apremilast Plus Placebo Injection|Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165888|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165889|NCT01690299|O3|Outcome|Etanercept Plus Placebo Tablets|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165890|NCT01690299|O2|Outcome|Apremilast Plus Placebo Injection|Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165891|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165892|NCT01690299|O3|Outcome|Etanercept Plus Placebo Tablets|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165893|NCT01690299|O2|Outcome|Apremilast Plus Placebo Injection|Participants received Apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165894|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165895|NCT01690299|O3|Outcome|Etanercept 50mg Plus Placebo Tablet|Etanercept 50 mg by SC injection QW plus placebo tablets PO, BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165896|NCT01690299|O2|Outcome|Apremilast 30mg Plus Placebo Injection|Apremilast 30 mg PO BID plus 2-1ml placebo SC saline injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165897|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165898|NCT01690299|O3|Outcome|Etanercept Plus Placebo Tablet|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165899|NCT01690299|O2|Outcome|Apremilast Plus Placebo Injection|Participants received Apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165900|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165901|NCT01690299|O3|Outcome|Etanercept Plus Placebo Tablets|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
166315|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
165902|NCT01690299|O2|Outcome|Apremilast Plus Placebo Injection|Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165903|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165904|NCT01690299|O3|Outcome|Etanercept Plus Placebo Tablet|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase.
165905|NCT01690299|O2|Outcome|Apremilast Plus Placebo Injection|Participants received Apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165906|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165907|NCT01690299|O2|Outcome|Etanercept 50mg Plus Placebo Tablet|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase.
165908|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165909|NCT01690299|O2|Outcome|Apremilast Plus Placebo Injection|Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165910|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165911|NCT01690299|E6|Reported Event|Etanercept/APR 30mg (Apremilast Exposure Phase) Weeks 16-104|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to apremilast 30mg PO BID through week 104.
165912|NCT01690299|E5|Reported Event|APR/APR 30 mg (Apremilast Exposure Phase) Weeks 0-104|Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID through week 104.
165913|NCT01690299|E4|Reported Event|Placebo/APR 30mg (Apremilast Exposure Phase) Weeks 16-104|Participants received identically matching placebo tablets by mouth (PO), twice a day (BID) and subcutaneous (SC) saline (placebo) injections (1mL x 2 injections SC) weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg Apremilast PO BID and remained on this dose through week 104.
165914|NCT01690299|E3|Reported Event|Etanercept Plus Placebo Tablets (Week 0-16)|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165915|NCT01690299|E2|Reported Event|Apremilast Plus Placebo Injection (Week 0-16)|Participants received Apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165916|NCT01690299|E1|Reported Event|Placebo (Week 0-16)|Participants received placebo tablets PO BID and 2-1 milliliter (ml) SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
165917|NCT01690273|B4|Baseline|Total|Total of all reporting groups
165918|NCT01690273|B3|Baseline|Elastic Resistance Exercise in AS|"stretching and elastic resistance exercises~stretching and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour) for sixteen weeks."
165919|NCT01690273|B2|Baseline|Stretching in AS|"stretching exercises~stretching exercise: 30 minutes, twice a week for sixteen weeks."
165920|NCT01690273|B1|Baseline|Ankylosing Spondylitis Control|Following a randomization, patients from control group stays during sixteen weeks only with medical treatment.
165921|NCT01690273|P3|Participant Flow|Mobility and Elastic Resistance Exercise in AS|"mobility, plus elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
165922|NCT01690273|P2|Participant Flow|Mobility in Ankylosing Spondylitis|"mobility exercises~mobility exercise: 30 minutes, twice a week"
165923|NCT01690273|P1|Participant Flow|Ankylosing Spondylitis Control|control group, no intervention in ankylosing spondylitis patients
165924|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
165925|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
165926|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
165927|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
165928|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
165929|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
165930|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
165931|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
165932|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
165933|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
165934|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
165935|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
166051|NCT01689779|O1|Outcome|Cholecalciferol|"40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery.~100, 000 IU cholecalciferol"
165936|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
165937|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
165938|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
165939|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
165940|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
165941|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
165942|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
165943|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
165944|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
165945|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
165946|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
165947|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
165948|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
165949|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
165950|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
165951|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
165952|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
165953|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
165954|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
165955|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
165956|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
165957|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
165958|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
165959|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
165960|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour) for sixteen weeks."
165961|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week for sixteen weeks."
165962|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|Following a randomization, patients from control group stays during sixteen weeks only with medical treatment.
165963|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
165964|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
165965|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group with AS patients and no exercise
165966|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
165967|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
165968|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group with AS patients and no exercise
165969|NCT01690273|E3|Reported Event|Elastic Resistance Exercise in AS|"stretching and elastic resistance exercises~stretching and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour) for sixteen weeks."
165970|NCT01690273|E2|Reported Event|Stretching in AS|"stretching exercises~stretching exercise: 30 minutes, twice a week for sixteen weeks."
165971|NCT01690273|E1|Reported Event|Ankylosing Spondylitis Control|Following a randomization, patients from control group stays during sixteen weeks only with medical treatment.
165972|NCT01690117|B3|Baseline|Total|Total of all reporting groups
165973|NCT01690117|B2|Baseline|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
165974|NCT01690117|B1|Baseline|DeREACH-program|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
165975|NCT01690117|P2|Participant Flow|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
165976|NCT01690117|P1|Participant Flow|DeREACH-program|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
165977|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
166052|NCT01689779|O2|Outcome|Sugar Pill|"40 patients will receive a sugar pill orally 3-7 days before surgery.~Placebo: sugar pill"
183853|NCT01627002|O2|Outcome|Part A PA401 3.0 mg|
165978|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
165979|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
165980|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
165981|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
165982|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
165983|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
165984|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
165985|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
165986|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
165987|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
165988|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
165989|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
165990|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
165991|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
165992|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
165993|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
165994|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
165995|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
165996|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
165997|NCT01690117|O2|Outcome|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
165998|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
165999|NCT01690117|O2|Outcome|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
166000|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
166001|NCT01690117|O2|Outcome|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
166002|NCT01690117|O1|Outcome|DeREACH-program|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
166003|NCT01690117|O2|Outcome|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
166004|NCT01690117|O1|Outcome|DeREACH-program|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
166005|NCT01690117|O2|Outcome|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
166006|NCT01690117|O1|Outcome|DeREACH-program|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
166007|NCT01690117|O2|Outcome|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
166008|NCT01690117|O1|Outcome|DeREACH-program|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
166009|NCT01690117|E2|Reported Event|Control Group|Serious and Other [Not Including Serious] Adverse Events were not monitored/assessed.
166010|NCT01690117|E1|Reported Event|Intervention Group|Serious and Other [Not Including Serious] Adverse Events were not monitored/assessed.
166011|NCT01690052|B1|Baseline|All Participants|"Two interventions were assembled:~For the first intervention, the SEQUENCE was cevimeline (30mg three times a day) for 4 weeks and then Pilocarpine (5 mg three times a day) for 4 weeks, after the first sequence, the participants had a washout period for one week.~For the second intervention, the SEQUENCE was Pilocarpine (5mg three times a day) or 4 weeks and then Cevimeline (30 mg three times a day) for 4 weeks, after the first sequence, the participants had a washout period for one week."
166012|NCT01690052|P2|Participant Flow|Pilocarpine First, Then Cevimeline|Pilocarpine First then Cevimeline: Pilocarpine (5 mg three times a day) for 4 weeks (first intervention period) and then Cevimeline (30mg three times a day) for 4 weeks (second intervention period). In between first and second intervention period, participants had a washout period for one week.
166013|NCT01690052|P1|Participant Flow|Cevimeline First, Then Pilocarpine|Cevimeline First then Pilocarpine: Cevimeline (30mg three times a day) for 4 weeks (First intervention period) and then pilocarpine (5 mg three times a day) for 4 weeks (second intervention period). In between first and second intervention period, participants had a washout period for one week.
166014|NCT01690052|O2|Outcome|Pilocarpine|Pilocarpine 5 mg administered three times a day in either first intervention period or second intervention period
166015|NCT01690052|O1|Outcome|Cevimeline|Cevimeline 30mg administered three times a day in first intervention period or second intervention period for 4 weeks.
166016|NCT01690052|E2|Reported Event|Pilocarpine Then Cevimeline (Intervention 2)|Pilocarpine then cevimeline One week washout period
166017|NCT01690052|E1|Reported Event|Cevimeline Then Pilocarpine (Intervention 1)|Cevimeline then pilocarpine One week washout period
166018|NCT01690000|B3|Baseline|Total|Total of all reporting groups
166019|NCT01690000|B2|Baseline|Placebo|Identical placebo given nightly for 12 months
166020|NCT01690000|B1|Baseline|Melatonin1+3|Melatonin: 1 or 3 mg of melatonin PO each night for 12 months
166021|NCT01690000|P2|Participant Flow|Placebo|Identical placebo given nightly for 12 months
166022|NCT01690000|P1|Participant Flow|Melatonin1+3|Melatonin: 1 or 3 mg of melatonin PO each night for 12 months
166023|NCT01690000|O2|Outcome|Placebo|"Identical placebo given nightly~Melatonin: 1 or 3 mg of melatonin PO each night for 12 months"
166024|NCT01690000|O1|Outcome|Melatonin1+3|"1+3 mg melatonin nightly~Melatonin: 1 or 3 mg of melatonin PO each night for 12 months"
166025|NCT01690000|E2|Reported Event|Placebo|Identical placebo given nightly for 12 months
166026|NCT01690000|E1|Reported Event|Melatonin1+3|Melatonin: 1 or 3 mg of melatonin PO each night for 12 months
166027|NCT01689974|B3|Baseline|Total|Total of all reporting groups
166028|NCT01689974|B2|Baseline|Arm B: Ipilimumab and Radiation|"Radiation Therapy and Ipilimumab. Radiation treatment is administered for 5 fractions (sessions) over 1 week. On Day 4 treatment with Ipilimumab begins and continues on Days 25, 46, and 67.~Radiation Therapy and Ipilimumab: Radiation is given over one week interval On the fourth day of radiation (day 4)Ipilimumab is administered and repeated on Days 25, 46 and 67."
166029|NCT01689974|B1|Baseline|Arm A: Ipilimumab|"Ipilimumab administered alone Day 4, 25, 46, and 67~Ipilimumab: Ipilimumab will be administered alone on day 4, 25, 46 and 67."
166030|NCT01689974|P2|Participant Flow|Arm B: Ipilimumab and Radiation|"Radiation Therapy and Ipilimumab. Radiation treatment is administered for 5 fractions (sessions) over 1 week. On Day 4 treatment with Ipilimumab begins and continues on Days 25, 46, and 67.~Radiation Therapy and Ipilimumab: Radiation is given over one week interval On the fourth day of radiation (day 4)Ipilimumab is administered and repeated on Days 25, 46 and 67."
166031|NCT01689974|P1|Participant Flow|Arm A: Ipilimumab|"Ipilimumab administered alone Day 4, 25, 46, and 67~Ipilimumab: Ipilimumab will be administered alone on day 4, 25, 46 and 67."
166032|NCT01689974|O2|Outcome|Arm B: Ipilimumab and Radiation|"Radiation Therapy and Ipilimumab. Radiation treatment is administered for 5 fractions (sessions) over 1 week. On Day 4 treatment with Ipilimumab begins and continues on Days 25, 46, and 67.~Radiation Therapy and Ipilimumab: Radiation is given over one week interval On the fourth day of radiation (day 4)Ipilimumab is administered and repeated on Days 25, 46 and 67."
166033|NCT01689974|O1|Outcome|Arm A: Ipilimumab|"Ipilimumab administered alone Day 4, 25, 46, and 67~Ipilimumab: Ipilimumab will be administered alone on day 4, 25, 46 and 67."
166034|NCT01689974|E2|Reported Event|Arm B: Ipilimumab and Radiation|"Radiation Therapy and Ipilimumab. Radiation treatment is administered for 5 fractions (sessions) over 1 week. On Day 4 treatment with Ipilimumab begins and continues on Days 25, 46, and 67.~Radiation Therapy and Ipilimumab: Radiation is given over one week interval On the fourth day of radiation (day 4)Ipilimumab is administered and repeated on Days 25, 46 and 67."
166035|NCT01689974|E1|Reported Event|Arm A: Ipilimumab|"Ipilimumab administered alone Day 4, 25, 46, and 67~Ipilimumab: Ipilimumab will be administered alone on day 4, 25, 46 and 67."
166036|NCT01689857|B3|Baseline|Total|Total of all reporting groups
166037|NCT01689857|B2|Baseline|Scarclinic™ Normal|Scarclinic™ Normal applied on the surgical scar for 12weeks
166038|NCT01689857|B1|Baseline|Scarclinic™ Thin|Scarclinic™ Thin applied on the surgical scar for 12weeks
166039|NCT01689857|P2|Participant Flow|Scarclinic™ Normal|Scarclinic™ Normal applied on the surgical scar for 12weeks
166040|NCT01689857|P1|Participant Flow|Scarclinic™ Thin|Scarclinic™ Thin applied on the surgical scar for 12weeks
166041|NCT01689857|O2|Outcome|Scarclinic™ Normal|Scarclinic™ Normal applied on the surgical scar for 12weeks
166042|NCT01689857|O1|Outcome|Scarclinic™ Thin|Scarclinic™ Thin applied on the surgical scar for 12weeks
166043|NCT01689857|E2|Reported Event|Scarclinic™ Normal|Scarclinic™ Normal applied on the surgical scar for 12weeks
166044|NCT01689857|E1|Reported Event|Scarclinic™ Thin|Scarclinic™ Thin applied on the surgical scar for 12weeks
166045|NCT01689779|B3|Baseline|Total|Total of all reporting groups
166046|NCT01689779|B2|Baseline|Sugar Pill|"40 patients will receive a sugar pill orally 3-7 days before surgery.~Placebo: sugar pill"
166047|NCT01689779|B1|Baseline|Cholecalciferol|"40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery.~100, 000 IU cholecalciferol"
166048|NCT01689779|P2|Participant Flow|Sugar Pill|"40 patients will receive a sugar pill orally 3-7 days before surgery.~Placebo: sugar pill"
166049|NCT01689779|P1|Participant Flow|Cholecalciferol|"40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery.~100, 000 IU cholecalciferol"
166053|NCT01689779|O1|Outcome|Cholecalciferol|"40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery.~100, 000 IU cholecalciferol"
166054|NCT01689779|O2|Outcome|Sugar Pill|"40 patients will receive a sugar pill orally 3-7 days before surgery.~Placebo: sugar pill"
166055|NCT01689779|O1|Outcome|Cholecalciferol|"40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery.~100, 000 IU cholecalciferol"
166056|NCT01689779|O2|Outcome|Sugar Pill|"40 patients will receive a sugar pill orally 3-7 days before surgery.~Placebo: sugar pill"
166057|NCT01689779|O1|Outcome|Cholecalciferol|"40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery.~100, 000 IU cholecalciferol"
166058|NCT01689779|O2|Outcome|Sugar Pill|"40 patients will receive a sugar pill orally 3-7 days before surgery.~Placebo: sugar pill"
166059|NCT01689779|O1|Outcome|Cholecalciferol|"40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery.~100, 000 IU cholecalciferol"
166060|NCT01689779|O2|Outcome|Sugar Pill|"40 patients will receive a sugar pill orally 3-7 days before surgery.~Placebo: sugar pill"
166061|NCT01689779|O1|Outcome|Cholecalciferol|"40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery.~100, 000 IU cholecalciferol"
166062|NCT01689779|E2|Reported Event|Sugar Pill|"40 patients will receive a sugar pill orally 3-7 days before surgery.~Placebo: sugar pill"
166063|NCT01689779|E1|Reported Event|Cholecalciferol|"40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery.~100, 000 IU cholecalciferol"
166064|NCT01689649|B1|Baseline|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
166065|NCT01689649|P1|Participant Flow|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
166066|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
166067|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
166068|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
166069|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
166070|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
166071|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
166072|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
166073|NCT01689649|E1|Reported Event|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral (PO) in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
166074|NCT01689532|B3|Baseline|Total|Total of all reporting groups
166075|NCT01689532|B2|Baseline|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166076|NCT01689532|B1|Baseline|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166077|NCT01689532|P2|Participant Flow|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166078|NCT01689532|P1|Participant Flow|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166079|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166080|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166081|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166082|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166083|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166084|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166085|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166086|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166087|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166088|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166089|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166090|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166091|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166092|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166093|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166094|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166095|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166096|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166097|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166098|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166099|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166100|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166101|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166102|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166103|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166104|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166105|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166106|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166107|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166108|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166109|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166110|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166111|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166112|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166113|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166212|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
166114|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166115|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166116|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166117|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166118|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166119|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166120|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166121|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166122|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166123|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166124|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166125|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166126|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166127|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166128|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166129|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166130|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166131|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166132|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166133|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166134|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166135|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166136|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166137|NCT01689532|E2|Reported Event|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
166138|NCT01689532|E1|Reported Event|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
166139|NCT01689519|B3|Baseline|Total|Total of all reporting groups
166140|NCT01689519|B2|Baseline|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
166141|NCT01689519|B1|Baseline|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
166142|NCT01689519|P2|Participant Flow|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
166143|NCT01689519|P1|Participant Flow|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
166144|NCT01689519|O2|Outcome|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
166145|NCT01689519|O1|Outcome|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
166146|NCT01689519|O2|Outcome|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
166147|NCT01689519|O1|Outcome|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
166148|NCT01689519|O2|Outcome|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
166149|NCT01689519|O1|Outcome|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
166150|NCT01689519|O2|Outcome|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
166151|NCT01689519|O1|Outcome|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
166152|NCT01689519|O2|Outcome|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
166153|NCT01689519|O1|Outcome|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
166154|NCT01689519|E2|Reported Event|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
166155|NCT01689519|E1|Reported Event|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
166156|NCT01689441|B3|Baseline|Total|Total of all reporting groups
166157|NCT01689441|B2|Baseline|Placebo|"Normal saline 2cc IV x 1~Placebo"
166158|NCT01689441|B1|Baseline|Calcitriol|"Calcitriol 2mcg IV x 1~Calcitriol"
166159|NCT01689441|P2|Participant Flow|Placebo|"Normal saline 2cc IV x 1~Placebo"
166160|NCT01689441|P1|Participant Flow|Calcitriol|"Calcitriol 2mcg IV x 1~Calcitriol"
166161|NCT01689441|O2|Outcome|Placebo|"Normal saline 2cc IV x 1~Placebo"
166162|NCT01689441|O1|Outcome|Calcitriol|"Calcitriol 2mcg IV x 1~Calcitriol"
166163|NCT01689441|O2|Outcome|Placebo|"Normal saline 2cc IV x 1~Placebo"
166164|NCT01689441|O1|Outcome|Calcitriol|"Calcitriol 2mcg IV x 1~Calcitriol"
166165|NCT01689441|O2|Outcome|Placebo|"Normal saline 2cc IV x 1~Placebo"
166166|NCT01689441|O1|Outcome|Calcitriol|"Calcitriol 2mcg IV x 1~Calcitriol"
166167|NCT01689441|E2|Reported Event|Placebo|"Normal saline 2cc IV x 1~Placebo"
166168|NCT01689441|E1|Reported Event|Calcitriol|"Calcitriol 2mcg IV x 1~Calcitriol"
166169|NCT01689363|B1|Baseline|Total Study Population|Subjects received four intradermal injections of study drug (two injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL), one injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL), one injection of 0.02 mL saline) in a random order at four locations on the subjects’ forearms.
166170|NCT01689363|P8|Participant Flow|P, H, N, H|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the upper-left forearm; 2) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-left forearm; 3) 0.02 mL saline at the upper-right forearm; 4) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-right forearm
166171|NCT01689363|P7|Participant Flow|P, H, H, N|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the upper-left forearm; 2) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-left forearm; 3) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-right forearm; 4) 0.02 mL saline at the lower-right forearm
166172|NCT01689363|P6|Participant Flow|N, H, P, H|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL saline at the upper-left forearm; 2) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-left forearm; 3) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the upper-right forearm; 4) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-right forearm
166173|NCT01689363|P5|Participant Flow|N, H, H, P|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL saline at the upper-left forearm; 2) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-left forearm; 3) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-right forearm; 4) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the lower-right forearm
166213|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
166214|NCT01689363|O1|Outcome|Intent-to-Treat Population (ITT)|Subjects who have been randomized
183854|NCT01627002|O1|Outcome|Part A PA401 1.0 mg|
166174|NCT01689363|P4|Participant Flow|H, P, N, H|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-left forearm; 2) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the lower-left forearm; 3) 0.02 mL saline at the upper-right forearm; 4) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-right forearm
166175|NCT01689363|P3|Participant Flow|H, P, H, N|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-left forearm; 2) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the lower-left forearm; 3) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-right forearm; 4) 0.02 mL saline at the lower-right forearm
166176|NCT01689363|P2|Participant Flow|H, N, P, H|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-left forearm; 2) 0.02 mL saline at the lower-left forearm; 3) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the upper-right forearm; 4) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-right forearm
166177|NCT01689363|P1|Participant Flow|H, N, H, P|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-left forearm; 2) 0.02 mL saline at the lower-left forearm; 3) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-right forearm; 4) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the lower-right forearm
166178|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
166179|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
166180|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
166181|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
166182|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
166183|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
166184|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
166185|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
166186|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
166187|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
166188|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
166189|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
166190|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
166191|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
166192|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
166193|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
166194|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
166195|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
166196|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
166197|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
166198|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
166199|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
166200|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
166201|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
166202|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
166203|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
166204|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
166205|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
166206|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
166207|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
166208|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
166209|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
166210|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
166211|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
166215|NCT01689363|O1|Outcome|Per-Protocol Population (PPP)|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments
166216|NCT01689363|E4|Reported Event|All Arms|Cannot identify which study drug may be associated with the ADE because the subject received all four injections almost at the same time
166217|NCT01689363|E3|Reported Event|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
166218|NCT01689363|E2|Reported Event|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
166219|NCT01689363|E1|Reported Event|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
166220|NCT01689350|B3|Baseline|Total|Total of all reporting groups
166221|NCT01689350|B2|Baseline|Experimental Group|47 cases in experimental group were genotyped as extensive metaboliser (EM), intermediate metaboliser (IM) and poor metaboliser (PM）with initial dose of CPA as 0.2g, 0.4g and 0.6g per week by injection, respectively.
166222|NCT01689350|B1|Baseline|Control Group|45 cases in control group received traditional therapy that the initial dose of cyclophosphamide (CPA) was 0.2-0.6g/week injection according to clinical experience.
166223|NCT01689350|P2|Participant Flow|Control Group|Cyclophosphamide (CPA) medication was according to the traditional experiences.
166224|NCT01689350|P1|Participant Flow|Experimental Group|Cyclophosphamide (CPA) medication was according to the genotypes of SLE patients.
166225|NCT01689350|O2|Outcome|Control Group|CPA medication was according to the traditional experiences.
166226|NCT01689350|O1|Outcome|Experimental Group|CPA medication was according to the genotypes of SLE patients.
166227|NCT01689350|O2|Outcome|Control Group|CPA medication was according to the traditional experiences.
166228|NCT01689350|O1|Outcome|Experimental Group|CPA medication was according to the genotypes of SLE patients.
166229|NCT01689350|E2|Reported Event|Control Group|Cyclophosphamide (CPA) medication was according to the traditional experiences.
166230|NCT01689350|E1|Reported Event|Experimental Group|Cyclophosphamide (CPA) medication was according to the genotypes of SLE patients.
166231|NCT01689337|B1|Baseline|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery.
166232|NCT01689337|P1|Participant Flow|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery.
166233|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
166234|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
166235|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
166236|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
166237|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
166238|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
166239|NCT01689337|O1|Outcome|AS902330, 100 mcg|AS902330 was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
166240|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery.
166241|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
166242|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery.
166243|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
166244|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
166245|NCT01689337|E1|Reported Event|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery.
166246|NCT01689324|B1|Baseline|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
166247|NCT01689324|P1|Participant Flow|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
166248|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
166249|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
166250|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
166251|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
166252|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
166253|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
166254|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
166255|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
166256|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
166257|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
166258|NCT01689324|E1|Reported Event|Study Group|Participants received a single booster dose of Tdap vaccine on Day 0.
166259|NCT01689207|B12|Baseline|Total|Total of all reporting groups
166260|NCT01689207|B11|Baseline|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
166261|NCT01689207|B10|Baseline|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
166262|NCT01689207|B9|Baseline|Part C: Placebo|Placebo
166263|NCT01689207|B8|Baseline|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
166264|NCT01689207|B7|Baseline|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
166265|NCT01689207|B6|Baseline|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
166266|NCT01689207|B5|Baseline|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
166267|NCT01689207|B4|Baseline|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
166268|NCT01689207|B3|Baseline|Part B: Placebo|Placebo
166269|NCT01689207|B2|Baseline|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
166270|NCT01689207|B1|Baseline|Part A: Placebo|Placebo
166271|NCT01689207|P11|Participant Flow|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
166272|NCT01689207|P10|Participant Flow|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
166273|NCT01689207|P9|Participant Flow|Part C: Placebo|Placebo
166274|NCT01689207|P8|Participant Flow|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
166275|NCT01689207|P7|Participant Flow|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
166276|NCT01689207|P6|Participant Flow|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
166277|NCT01689207|P5|Participant Flow|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
166278|NCT01689207|P4|Participant Flow|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
166279|NCT01689207|P3|Participant Flow|Part B: Placebo|Placebo
166280|NCT01689207|P2|Participant Flow|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
166281|NCT01689207|P1|Participant Flow|Part A: Placebo|Placebo
166282|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
166283|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
166284|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
166285|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
166286|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
166287|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
166288|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
166289|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
166290|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
166291|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
166292|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
166293|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
166294|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
166295|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
166296|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
166297|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
166298|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
166299|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
166300|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
166301|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
166302|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
166303|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
166304|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
166305|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
166306|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
166307|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
166308|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
166309|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
166310|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
166311|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
166312|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
166313|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
166316|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
166317|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
166318|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
166319|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
166320|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
166321|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
166322|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
166323|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
166324|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
166325|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
166326|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
166327|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
166328|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
166329|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
166330|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
166331|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
166332|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
166333|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
166334|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
166335|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
166336|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
166337|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
166338|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
166339|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
166340|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
166341|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
166342|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
166343|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
166344|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
166345|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
166346|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
166347|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
166348|NCT01689207|O14|Outcome|Part A: ATM 2000mg + AVI 600mg|Crossover period ATM 2000mg + AVI 600mg
166349|NCT01689207|O13|Outcome|Part A: Avibactam (AVI) 600mg|Crossover period AVI 600mg
166350|NCT01689207|O12|Outcome|Part A: Aztreonam (ATM) 2000mg|Crossover period ATm 2000mg
166351|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
166352|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
166353|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
166354|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
166355|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
166356|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
166357|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
166358|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
166359|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
166360|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
166361|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
166362|NCT01689207|E14|Reported Event|Part A: ATM 2000mg + AVI 600mg|Crossover period ATM 2000mg + AVI 600mg
166363|NCT01689207|E13|Reported Event|Part A: Avibactam (AVI) 600mg|Crossover period AVI 600mg
166364|NCT01689207|E12|Reported Event|Part A: Aztreonam (ATM) 2000mg|Crossover period ATM 2000mg
166365|NCT01689207|E11|Reported Event|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
166366|NCT01689207|E10|Reported Event|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
166367|NCT01689207|E9|Reported Event|Part C: Placebo|Placebo
166368|NCT01689207|E8|Reported Event|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
166369|NCT01689207|E7|Reported Event|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
166370|NCT01689207|E6|Reported Event|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
166371|NCT01689207|E5|Reported Event|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
166372|NCT01689207|E4|Reported Event|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
166373|NCT01689207|E3|Reported Event|Part B: Placebo|Placebo
166374|NCT01689207|E2|Reported Event|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
166375|NCT01689207|E1|Reported Event|Part A: Placebo|Placebo
166376|NCT01689155|B1|Baseline|Menactra Vaccine Recipients|Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
166377|NCT01689155|P1|Participant Flow|Menactra Vaccine Recipients|Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
166378|NCT01689155|O2|Outcome|Control Group|There was no separate control group per se. For all analyses, rates of events in a risk window for participants were compared with rates of events in a control window for the same participants.
166446|NCT01688830|B14|Baseline|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
166379|NCT01689155|O1|Outcome|Menactra Vaccine Recipients|Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
166380|NCT01689155|O2|Outcome|Control Group|There was no separate control group per se. For all analyses, rates of events in a risk window for participants were compared with rates of events in a control window for the same participants.
166381|NCT01689155|O1|Outcome|Menactra Vaccine Recipients|Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
166382|NCT01689155|O2|Outcome|Control Group|There was no separate control group per se. For all analyses, rates of events in a risk window for participants were compared with rates of events in a control window for the same participants.
166383|NCT01689155|O1|Outcome|Menactra Vaccine Recipients|Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
166384|NCT01689155|E1|Reported Event|Menactra Vaccine Recipients|Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
166385|NCT01688921|B3|Baseline|Total|Total of all reporting groups
166386|NCT01688921|B2|Baseline|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
166387|NCT01688921|B1|Baseline|STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~STRATIS needle-free injection device"
166388|NCT01688921|P2|Participant Flow|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
166389|NCT01688921|P1|Participant Flow|STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~STRATIS needle-free injection device"
166390|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the PJ STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
166391|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
166392|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
166393|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
166394|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
166395|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
166396|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
166397|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
166398|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
166399|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
166400|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
166401|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
166402|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
166403|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
166404|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
166405|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
166406|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
166407|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
166408|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the PJ STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
166409|NCT01688921|E2|Reported Event|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
166410|NCT01688921|E1|Reported Event|STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~STRATIS needle-free injection device"
166411|NCT01688882|B3|Baseline|Total|Total of all reporting groups
166412|NCT01688882|B2|Baseline|Placebo|Placebo to Match Q2W s.c.
166413|NCT01688882|B1|Baseline|QGE031|QGE031 240 mg Q2W s.c.
166414|NCT01688882|P2|Participant Flow|Placebo|Placebo to Match Q2W s.c.
166415|NCT01688882|P1|Participant Flow|QGE031|QGE031 240 mg Q2W s.c.
166416|NCT01688882|O2|Outcome|Placebo|Placebo to Match Q2W s.c.
166417|NCT01688882|O1|Outcome|QGE031|QGE031 240 mg Q2W s.c.
166418|NCT01688882|O2|Outcome|Placebo|Placebo to Match Q2W s.c.
166419|NCT01688882|O1|Outcome|QGE031|QGE031 240 mg Q2W s.c.
166420|NCT01688882|O2|Outcome|Placebo|Placebo to Match Q2W s.c.
166421|NCT01688882|O1|Outcome|QGE031|QGE031 240 mg Q2W s.c.
166422|NCT01688882|E6|Reported Event|Follow-up Period: Open Label QGE031|Follow-up Period after completion of Part 1 Open Label QGE031 Q2W s.c.
166423|NCT01688882|E5|Reported Event|Follow-up Period: Placebo|Follow-up Period after completion of Part 1 Placebo to Match Q2W s.c.
166424|NCT01688882|E4|Reported Event|Follow-up Period: QGE031|Follow-up Period after completion of Part 1 QGE031 240 mg Q2W s.c.
166425|NCT01688882|E3|Reported Event|Open Label QGE031|Open Label QGE031 Q2W s.c.
166426|NCT01688882|E2|Reported Event|Placebo|Placebo to Match Q2W s.c.
166427|NCT01688882|E1|Reported Event|QGE031|QGE031 240 mg Q2W s.c
166428|NCT01688843|B1|Baseline|INGEVITY Lead|INGEVITY lead implant
166429|NCT01688843|P1|Participant Flow|INGEVITY Study Participants|Each participant was allowed to have up to 2 INGEVITY leads contribute to endpoint analyses -- one per chamber (right atrium and right ventricle). Final lead implanted or attempted during initial procedure per chamber was used for analysis.
166430|NCT01688843|O1|Outcome|INGEVITY Lead|INGEVITY lead implant
166431|NCT01688843|O1|Outcome|INGEVITY Lead|INGEVITY lead implant
166432|NCT01688843|O1|Outcome|INGEVITY Lead|INGEVITY lead implant
166433|NCT01688843|O1|Outcome|INGEVITY Lead|INGEVITY lead implant
166434|NCT01688843|O1|Outcome|INGEVITY Lead|Implanted/Attempted Leads
166435|NCT01688843|O1|Outcome|INGEVITY Lead|Implanted/Attempted Leads
166436|NCT01688843|O1|Outcome|INGEVITY Lead|Implanted/Attempted Leads
166437|NCT01688843|E1|Reported Event|INGEVITY Study Participants|
166438|NCT01688830|B22|Baseline|Total|Total of all reporting groups
166439|NCT01688830|B21|Baseline|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166440|NCT01688830|B20|Baseline|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166441|NCT01688830|B19|Baseline|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166442|NCT01688830|B18|Baseline|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166443|NCT01688830|B17|Baseline|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166444|NCT01688830|B16|Baseline|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166445|NCT01688830|B15|Baseline|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
168354|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
166447|NCT01688830|B13|Baseline|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum~This is administered during Part 1 of the study"
166448|NCT01688830|B12|Baseline|Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo~This is administered during Part 1 of the study"
166449|NCT01688830|B11|Baseline|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum~This is administered during Part 1 of the study"
166450|NCT01688830|B10|Baseline|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum~This is administered during Part 1 of the study"
166451|NCT01688830|B9|Baseline|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
166452|NCT01688830|B8|Baseline|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum~This is administered during Part 1 of the study"
166453|NCT01688830|B7|Baseline|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
166454|NCT01688830|B6|Baseline|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum~This is administered during Part 1 of the study"
166455|NCT01688830|B5|Baseline|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum~This is administered during Part 1 of the study"
166456|NCT01688830|B4|Baseline|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum~This is administered during Part 1 of the study"
166457|NCT01688830|B3|Baseline|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum~This is administered during Part 1 of the study"
166458|NCT01688830|B2|Baseline|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum~This is administered during Part 1 of the study"
166459|NCT01688830|B1|Baseline|Placebo 1 h|"One single intravenous long infusion (1 h) of Idarucizumab Placebo~This is administered during Part 1 of the study"
166460|NCT01688830|P21|Participant Flow|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166461|NCT01688830|P20|Participant Flow|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166462|NCT01688830|P19|Participant Flow|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166463|NCT01688830|P18|Participant Flow|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166464|NCT01688830|P17|Participant Flow|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166465|NCT01688830|P16|Participant Flow|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166466|NCT01688830|P15|Participant Flow|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
166467|NCT01688830|P14|Participant Flow|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
166468|NCT01688830|P13|Participant Flow|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum~This is administered during Part 1 of the study"
166469|NCT01688830|P12|Participant Flow|Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo~This is administered during Part 1 of the study"
166470|NCT01688830|P11|Participant Flow|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum~This is administered during Part 1 of the study"
166471|NCT01688830|P10|Participant Flow|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum~This is administered during Part 1 of the study"
166472|NCT01688830|P9|Participant Flow|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
166473|NCT01688830|P8|Participant Flow|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum~This is administered during Part 1 of the study"
166474|NCT01688830|P7|Participant Flow|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
166475|NCT01688830|P6|Participant Flow|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum~This is administered during Part 1 of the study"
166476|NCT01688830|P5|Participant Flow|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum~This is administered during Part 1 of the study"
166477|NCT01688830|P4|Participant Flow|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum~This is administered during Part 1 of the study"
166478|NCT01688830|P3|Participant Flow|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum~This is administered during Part 1 of the study"
166637|NCT01688726|E1|Reported Event|SYSTANE BALANCE|One drop 4 times a day for a continuous period of 1 month
166479|NCT01688830|P2|Participant Flow|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum~This is administered during Part 1 of the study"
166480|NCT01688830|P1|Participant Flow|Placebo 1 h|"One single intravenous long infusion (1 h) of Idarucizumab Placebo~This is administered during Part 1 of the study"
166481|NCT01688830|O2|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166482|NCT01688830|O1|Outcome|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166483|NCT01688830|O4|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166484|NCT01688830|O3|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166485|NCT01688830|O2|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166486|NCT01688830|O1|Outcome|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166487|NCT01688830|O8|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166488|NCT01688830|O7|Outcome|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166489|NCT01688830|O6|Outcome|DE (Dose Groups 17: Day 3)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 in dose group 17
166490|NCT01688830|O5|Outcome|DE+ 4 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166491|NCT01688830|O4|Outcome|DE+ 2 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166492|NCT01688830|O3|Outcome|DE+ 1 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166493|NCT01688830|O2|Outcome|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166494|NCT01688830|O1|Outcome|DE (Dose Groups 14−16: Day 3)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 in dose groups 14-16
166495|NCT01688830|O6|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166496|NCT01688830|O5|Outcome|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166497|NCT01688830|O4|Outcome|DE+ 4 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166498|NCT01688830|O3|Outcome|DE+ 2 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166499|NCT01688830|O2|Outcome|DE+ 1 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166500|NCT01688830|O1|Outcome|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166501|NCT01688830|O8|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166972|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
166502|NCT01688830|O7|Outcome|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166503|NCT01688830|O6|Outcome|DE (Dose Groups 17: Day 3)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 in dose group 17
166504|NCT01688830|O5|Outcome|DE+ 4 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166505|NCT01688830|O4|Outcome|DE+ 2 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166506|NCT01688830|O3|Outcome|DE+ 1 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166507|NCT01688830|O2|Outcome|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166508|NCT01688830|O1|Outcome|DE (Dose Groups 14−16: Day 3)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 in dose groups 14-16
166509|NCT01688830|O21|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166510|NCT01688830|O20|Outcome|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166511|NCT01688830|O19|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166512|NCT01688830|O18|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166513|NCT01688830|O17|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166514|NCT01688830|O16|Outcome|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166515|NCT01688830|O15|Outcome|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
166516|NCT01688830|O14|Outcome|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
166517|NCT01688830|O13|Outcome|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum~This is administered during Part 1 of the study"
166518|NCT01688830|O12|Outcome|Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo~This is administered during Part 1 of the study"
166519|NCT01688830|O11|Outcome|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum~This is administered during Part 1 of the study"
166520|NCT01688830|O10|Outcome|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum~This is administered during Part 1 of the study"
166521|NCT01688830|O9|Outcome|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
166522|NCT01688830|O8|Outcome|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum~This is administered during Part 1 of the study"
166523|NCT01688830|O7|Outcome|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
166524|NCT01688830|O6|Outcome|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum~This is administered during Part 1 of the study"
166525|NCT01688830|O5|Outcome|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum~This is administered during Part 1 of the study"
166526|NCT01688830|O4|Outcome|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum~This is administered during Part 1 of the study"
166527|NCT01688830|O3|Outcome|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum~This is administered during Part 1 of the study"
166528|NCT01688830|O2|Outcome|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum~This is administered during Part 1 of the study"
166529|NCT01688830|O1|Outcome|Placebo 1 h|"One single intravenous long infusion (1 h) of Idarucizumab Placebo~This is administered during Part 1 of the study"
166530|NCT01688830|O17|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166531|NCT01688830|O16|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166532|NCT01688830|O15|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166533|NCT01688830|O14|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166534|NCT01688830|O13|Outcome|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
166535|NCT01688830|O12|Outcome|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
166536|NCT01688830|O11|Outcome|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum~This is administered during Part 1 of the study"
166537|NCT01688830|O10|Outcome|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum~This is administered during Part 1 of the study"
166538|NCT01688830|O9|Outcome|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum~This is administered during Part 1 of the study"
166539|NCT01688830|O8|Outcome|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
166540|NCT01688830|O7|Outcome|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum~This is administered during Part 1 of the study"
166541|NCT01688830|O6|Outcome|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
166542|NCT01688830|O5|Outcome|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum~This is administered during Part 1 of the study"
166543|NCT01688830|O4|Outcome|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum~This is administered during Part 1 of the study"
166544|NCT01688830|O3|Outcome|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum~This is administered during Part 1 of the study"
166545|NCT01688830|O2|Outcome|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum~This is administered during Part 1 of the study"
166546|NCT01688830|O1|Outcome|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum~This is administered during Part 1 of the study"
166547|NCT01688830|O17|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166548|NCT01688830|O16|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166549|NCT01688830|O15|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166550|NCT01688830|O14|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166551|NCT01688830|O13|Outcome|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
166552|NCT01688830|O12|Outcome|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
166553|NCT01688830|O11|Outcome|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum~This is administered during Part 1 of the study"
166554|NCT01688830|O10|Outcome|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum~This is administered during Part 1 of the study"
166555|NCT01688830|O9|Outcome|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum~This is administered during Part 1 of the study"
166556|NCT01688830|O8|Outcome|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
166557|NCT01688830|O7|Outcome|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum~This is administered during Part 1 of the study"
166558|NCT01688830|O6|Outcome|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
166559|NCT01688830|O5|Outcome|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum~This is administered during Part 1 of the study"
166560|NCT01688830|O4|Outcome|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum~This is administered during Part 1 of the study"
166561|NCT01688830|O3|Outcome|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum~This is administered during Part 1 of the study"
166562|NCT01688830|O2|Outcome|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum~This is administered during Part 1 of the study"
166563|NCT01688830|O1|Outcome|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum~This is administered during Part 1 of the study"
166564|NCT01688830|O17|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166565|NCT01688830|O16|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166566|NCT01688830|O15|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166567|NCT01688830|O14|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166568|NCT01688830|O13|Outcome|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
166569|NCT01688830|O12|Outcome|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
166570|NCT01688830|O11|Outcome|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum~This is administered during Part 1 of the study"
166571|NCT01688830|O10|Outcome|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum~This is administered during Part 1 of the study"
166572|NCT01688830|O9|Outcome|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum~This is administered during Part 1 of the study"
166573|NCT01688830|O8|Outcome|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
166574|NCT01688830|O7|Outcome|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum~This is administered during Part 1 of the study"
166575|NCT01688830|O6|Outcome|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
166576|NCT01688830|O5|Outcome|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum~This is administered during Part 1 of the study"
166577|NCT01688830|O4|Outcome|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum~This is administered during Part 1 of the study"
166578|NCT01688830|O3|Outcome|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum~This is administered during Part 1 of the study"
166579|NCT01688830|O2|Outcome|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum~This is administered during Part 1 of the study"
166580|NCT01688830|O1|Outcome|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum~This is administered during Part 1 of the study"
166581|NCT01688830|O17|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166582|NCT01688830|O16|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166583|NCT01688830|O15|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166584|NCT01688830|O14|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166585|NCT01688830|O13|Outcome|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
166586|NCT01688830|O12|Outcome|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
166587|NCT01688830|O11|Outcome|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum~This is administered during Part 1 of the study"
166588|NCT01688830|O10|Outcome|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum~This is administered during Part 1 of the study"
166589|NCT01688830|O9|Outcome|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum~This is administered during Part 1 of the study"
166590|NCT01688830|O8|Outcome|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
166591|NCT01688830|O7|Outcome|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum~This is administered during Part 1 of the study"
166592|NCT01688830|O6|Outcome|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
166593|NCT01688830|O5|Outcome|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum~This is administered during Part 1 of the study"
168655|NCT01681576|O1|Outcome|LCZ696 - ALL|LCZ696 400mg
166594|NCT01688830|O4|Outcome|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum~This is administered during Part 1 of the study"
166595|NCT01688830|O3|Outcome|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum~This is administered during Part 1 of the study"
166596|NCT01688830|O2|Outcome|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum~This is administered during Part 1 of the study"
166597|NCT01688830|O1|Outcome|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum~This is administered during Part 1 of the study"
166598|NCT01688830|E25|Reported Event|DE+ 5 g + 2.5 g Idarucizumab|"Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166599|NCT01688830|E24|Reported Event|DE+ 5 g|"One single intravenous short infusion (5 min) of 5 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166600|NCT01688830|E23|Reported Event|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166601|NCT01688830|E22|Reported Event|DE+ Placebo|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166602|NCT01688830|E21|Reported Event|DE (Dose Groups 17)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 and in the morning of Day 4 in dose group 17
166603|NCT01688830|E20|Reported Event|DE+ 2 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166604|NCT01688830|E19|Reported Event|DE+ 4 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166605|NCT01688830|E18|Reported Event|DE+ 1 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 1g of Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166606|NCT01688830|E17|Reported Event|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
166607|NCT01688830|E16|Reported Event|DE (Dose Groups 14−16)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 and in the morning of Day 4 in dose groups 14-16
166608|NCT01688830|E15|Reported Event|4 g Idarucizumab 5min|One single intravenous short infusion (5 min) of 4 g Idarucizumab verum
166609|NCT01688830|E14|Reported Event|2 g Idarucizumab 5min|Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum
166610|NCT01688830|E13|Reported Event|1 g Idarucizumab 5min|One single intravenous short infusion (5 min) of 1 g Idarucizumab verum
166611|NCT01688830|E12|Reported Event|Placebo 5min|One single intravenous short infusion (5 min) of Idarucizumab Placebo
166612|NCT01688830|E11|Reported Event|8 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 8 g Idarucizumab verum
166613|NCT01688830|E10|Reported Event|6 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 6 g Idarucizumab verum
166614|NCT01688830|E9|Reported Event|4 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 4 g Idarucizumab verum
166615|NCT01688830|E8|Reported Event|3 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 3 g Idarucizumab verum
166616|NCT01688830|E7|Reported Event|2 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 2 g Idarucizumab verum
166617|NCT01688830|E6|Reported Event|1.2 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum
166618|NCT01688830|E5|Reported Event|600 mg Idarucizumab 1h|One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum
166619|NCT01688830|E4|Reported Event|200 mg Idarucizumab 1h|One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum
166620|NCT01688830|E3|Reported Event|60 mg Idarucizumab 1h|One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum
166621|NCT01688830|E2|Reported Event|20 mg Idarucizumab 1h|One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum
166622|NCT01688830|E1|Reported Event|Placebo 1 h|One single intravenous long infusion (1 h) of Idarucizumab Placebo
166623|NCT01688726|B3|Baseline|Total|Total of all reporting groups
166624|NCT01688726|B2|Baseline|Minims Saline|One drop 4 times a day for a continuous period of 1 month
166625|NCT01688726|B1|Baseline|SYSTANE BALANCE|One drop 4 times a day for a continuous period of 1 month
166626|NCT01688726|P2|Participant Flow|Minims Saline|One drop 4 times a day for a continuous period of 1 month
166627|NCT01688726|P1|Participant Flow|SYSTANE BALANCE|One drop 4 times a day for a continuous period of 1 month
166628|NCT01688726|O4|Outcome|Minims Saline/Left Eye|One drop 4 times a day for 1 month
166629|NCT01688726|O3|Outcome|Minims Saline/Right Eye|One drop 4 times a day for 1 month
166630|NCT01688726|O2|Outcome|SYSTANE BALANCE/Left Eye|One drop 4 times a day for 1 month
166631|NCT01688726|O1|Outcome|SYSTANE BALANCE/Right Eye|One drop 4 times a day for 1 month
166632|NCT01688726|O2|Outcome|Minims Saline|One drop 4 times a day for a continuous period of 1 month
166633|NCT01688726|O1|Outcome|SYSTANE BALANCE|One drop 4 times a day for a continuous period of 1 month
166634|NCT01688726|O2|Outcome|Minims Saline|One drop 4 times a day for a continuous period of 1 month
166635|NCT01688726|O1|Outcome|SYSTANE BALANCE|One drop 4 times a day for a continuous period of 1 month
166636|NCT01688726|E2|Reported Event|Minims Saline|One drop 4 times a day for a continuous period of 1 month
166638|NCT01688635|B1|Baseline|LY2963016 and US-approved Lantus|Single 0.5-units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study; Single 0.5-U/kg dose of US-approved Lantus administered subcutaneously twice during the study. There was at least a 7-day washout between treatment periods.
166639|NCT01688635|P2|Participant Flow|Lantus/LY/Lantus/LY|"A single 0.5-U/kg dose of US-approved Lantus administered subcutaneously during Periods 1 and 3.~A single 0.5-U/kg dose of LY2963016 administered subcutaneously during Periods 2 and 4.~There was at least a 7-day washout between treatment periods."
166640|NCT01688635|P1|Participant Flow|LY/Lantus/LY/Lantus|"A single 0.5-units/kilogram (U/kg) dose of LY2963016 (LY) administered subcutaneously during Periods 1 and 3.~A single 0.5-U/kg dose of US-approved Lantus (Lantus) administered subcutaneously during Periods 2 and 4.~There was at least a 7-day washout between treatment periods."
166641|NCT01688635|O2|Outcome|US-approved Lantus|"Single 0.5-U/kg dose of US-approved Lantus administered subcutaneously twice during the study.~There was at least a 7-day washout between treatment periods."
166642|NCT01688635|O1|Outcome|LY2963016|"Single 0.5-units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study.~There was at least a 7-day washout between treatment periods."
166643|NCT01688635|O2|Outcome|US-approved Lantus|"Single 0.5-U/kg dose of US-approved Lantus administered subcutaneously twice during the study.~There was at least a 7-day washout between treatment periods."
166644|NCT01688635|O1|Outcome|LY2963016|"Single 0.5-units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study.~There was at least a 7-day washout between treatment periods."
166645|NCT01688635|O2|Outcome|US-approved Lantus|"Single 0.5-U/kg dose of US-approved Lantus administered subcutaneously twice during the study.~There was at least a 7-day washout between treatment periods."
166646|NCT01688635|O1|Outcome|LY2963016|"Single 0.5-units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study.~There was at least a 7-day washout between treatment periods."
166647|NCT01688635|O2|Outcome|US-approved Lantus|"Single 0.5-U/kg dose of US-approved Lantus administered subcutaneously twice during the study.~There was at least a 7-day washout between treatment periods."
166648|NCT01688635|O1|Outcome|LY2963016|Single 0.5-units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study. There was at least a 7-day washout between treatment periods.
166649|NCT01688635|E2|Reported Event|US-approved Lantus|"Single 0.5 U/kg dose of US-approved Lantus administered subcutaneously twice during the study.~There was at least a 7-day washout between the treatment periods."
166650|NCT01688635|E1|Reported Event|LY2963016|"Single 0.5 units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study.~There was at least a 7-day washout between the treatment periods."
166651|NCT01688609|B1|Baseline|Treatment (Lapatinib, Trastuzumab, Paclitaxel, Surgery)|"Drug exposure: Patients receive lapatinib ditosylate PO QD and trastuzumab IV over 30-90 minutes once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.~Preoperative therapy: Patients receive lapatinib ditosylate PO QD, trastuzumab IV over 30 minutes once weekly, and paclitaxel IV over 90 minutes once weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo lumpectomy or mastectomy.~lapatinib ditosylate: Given PO~paclitaxel: Given IV~trastuzumab: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
166652|NCT01688609|P1|Participant Flow|Treatment (Lapatinib, Trastuzumab, Paclitaxel, Surgery)|"Drug exposure: Patients receive lapatinib ditosylate PO QD and trastuzumab IV over 30-90 minutes once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.~Preoperative therapy: Patients receive lapatinib ditosylate PO QD, trastuzumab IV over 30 minutes once weekly, and paclitaxel IV over 90 minutes once weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo lumpectomy or mastectomy.~lapatinib ditosylate: Given PO~paclitaxel: Given IV~trastuzumab: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
166653|NCT01688609|O1|Outcome|Treatment (Lapatinib, Trastuzumab, Paclitaxel, Surgery)|"Drug exposure: Patients receive lapatinib ditosylate PO QD and trastuzumab IV over 30-90 minutes once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.~Preoperative therapy: Patients receive lapatinib ditosylate PO QD, trastuzumab IV over 30 minutes once weekly, and paclitaxel IV over 90 minutes once weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo lumpectomy or mastectomy.~lapatinib ditosylate: Given PO~paclitaxel: Given IV~trastuzumab: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
166654|NCT01688609|O1|Outcome|Treatment (Lapatinib, Trastuzumab, Paclitaxel, Surgery)|"Drug exposure: Patients receive lapatinib ditosylate PO QD and trastuzumab IV over 30-90 minutes once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.~Preoperative therapy: Patients receive lapatinib ditosylate PO QD, trastuzumab IV over 30 minutes once weekly, and paclitaxel IV over 90 minutes once weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo lumpectomy or mastectomy.~lapatinib ditosylate: Given PO~paclitaxel: Given IV~trastuzumab: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
166655|NCT01688609|O1|Outcome|Treatment (Lapatinib, Trastuzumab, Paclitaxel, Surgery)|"Drug exposure: Patients receive lapatinib ditosylate PO QD and trastuzumab IV over 30-90 minutes once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.~Preoperative therapy: Patients receive lapatinib ditosylate PO QD, trastuzumab IV over 30 minutes once weekly, and paclitaxel IV over 90 minutes once weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo lumpectomy or mastectomy.~lapatinib ditosylate: Given PO~paclitaxel: Given IV~trastuzumab: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
166676|NCT01688336|O1|Outcome|FOLFIRINOX|"FOLFIRINOX given to all subjects~FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:~Oxaliplatin (85 mg/m2)~Leucovorin (400mg/ m2)~Irinotecan (180 mg/m2)~5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours"
166973|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
166656|NCT01688609|O1|Outcome|Treatment (Lapatinib, Trastuzumab, Paclitaxel, Surgery)|"Drug exposure: Patients receive lapatinib ditosylate PO QD and trastuzumab IV over 30-90 minutes once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.~Preoperative therapy: Patients receive lapatinib ditosylate PO QD, trastuzumab IV over 30 minutes once weekly, and paclitaxel IV over 90 minutes once weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo lumpectomy or mastectomy.~lapatinib ditosylate: Given PO~paclitaxel: Given IV~trastuzumab: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
166657|NCT01688609|O1|Outcome|Treatment (Lapatinib, Trastuzumab, Paclitaxel, Surgery)|"Drug exposure: Patients receive lapatinib ditosylate PO QD and trastuzumab IV over 30-90 minutes once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.~Preoperative therapy: Patients receive lapatinib ditosylate PO QD, trastuzumab IV over 30 minutes once weekly, and paclitaxel IV over 90 minutes once weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo lumpectomy or mastectomy.~lapatinib ditosylate: Given PO~paclitaxel: Given IV~trastuzumab: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
166658|NCT01688609|E1|Reported Event|Treatment (Lapatinib, Trastuzumab, Paclitaxel, Surgery)|"Drug exposure: Patients receive lapatinib ditosylate PO QD and trastuzumab IV over 30-90 minutes once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.~Preoperative therapy: Patients receive lapatinib ditosylate PO QD, trastuzumab IV over 30 minutes once weekly, and paclitaxel IV over 90 minutes once weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo lumpectomy or mastectomy.~lapatinib ditosylate: Given PO~paclitaxel: Given IV~trastuzumab: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
166659|NCT01688466|B3|Baseline|Total|Total of all reporting groups
166660|NCT01688466|B2|Baseline|0.5 mg/Day Without Dose Escalation|"0.5 mg/day without Dose Escalation~Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle"
166661|NCT01688466|B1|Baseline|0.5 mg/Day With Dose Escalation|"0.5 mg/day with Dose Escalation by 0.5 mg/day increments every 2 weeks to a maximum of 2.0 mg/day~Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle"
166662|NCT01688466|P2|Participant Flow|0.5 mg/Day Without Dose Escalation|"0.5 mg/day without Dose Escalation~Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle"
166663|NCT01688466|P1|Participant Flow|0.5 mg/Day With Dose Escalation|"0.5 mg/day with Dose Escalation by 0.5 mg/day increments every 2 weeks to a maximum of 2.0 mg/day~Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle"
166664|NCT01688466|O2|Outcome|0.5 mg/Day Without Dose Escalation|"0.5 mg/day without Dose Escalation~Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle"
166665|NCT01688466|O1|Outcome|0.5 mg/Day With Dose Escalation|"0.5 mg/day with Dose Escalation by 0.5 mg/day increments every 2 weeks to a maximum of 2.0 mg/day~Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle"
166666|NCT01688466|O2|Outcome|0.5 mg/Day Without Dose Escalation|"0.5 mg/day without Dose Escalation~Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle"
166667|NCT01688466|O1|Outcome|0.5 mg/Day With Dose Escalation|"0.5 mg/day with Dose Escalation by 0.5 mg/day increments every 2 weeks to a maximum of 2.0 mg/day~Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle"
166668|NCT01688466|E2|Reported Event|0.5 mg/Day Without Dose Escalation|"0.5 mg/day without Dose Escalation~Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle"
166669|NCT01688466|E1|Reported Event|0.5 mg/Day With Dose Escalation|"0.5 mg/day with Dose Escalation by 0.5 mg/day increments every 2 weeks to a maximum of 2.0 mg/day~Pomalidomide: 0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle"
166670|NCT01688336|B1|Baseline|FOLFIRINOX|"FOLFIRINOX given to all subjects~FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:~Oxaliplatin (85 mg/m2)~Leucovorin (400mg/ m2)~Irinotecan (180 mg/m2)~5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours"
166671|NCT01688336|P1|Participant Flow|FOLFIRINOX|"FOLFIRINOX given to all subjects~FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:~Oxaliplatin (85 mg/m2)~Leucovorin (400mg/ m2)~Irinotecan (180 mg/m2)~Fluorouracil (5FU) (400mg/m2)bolus then 2400 mg/m2 over 46 hours"
166672|NCT01688336|O1|Outcome|FOLFIRINOX|"FOLFIRINOX given to all subjects~FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:~Oxaliplatin (85 mg/m2)~Leucovorin (400mg/ m2)~Irinotecan (180 mg/m2)~Fluorouracil (5FU) (400mg/m2)bolus then 2400 mg/m2 over 46 hours"
166673|NCT01688336|O1|Outcome|FOLFIRINOX|"FOLFIRINOX given to all subjects~FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:~Oxaliplatin (85 mg/m2)~Leucovorin (400mg/ m2)~Irinotecan (180 mg/m2)~5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours"
166674|NCT01688336|O1|Outcome|FOLFIRINOX|"FOLFIRINOX given to all subjects~FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:~Oxaliplatin (85 mg/m2)~Leucovorin (400mg/ m2)~Irinotecan (180 mg/m2)~5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours"
166675|NCT01688336|O1|Outcome|FOLFIRINOX|"FOLFIRINOX given to all subjects~FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:~Oxaliplatin (85 mg/m2)~Leucovorin (400mg/ m2)~Irinotecan (180 mg/m2)~5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours"
166751|NCT01688037|O1|Outcome|Placebo|Participants received Placebo capsule (matching valbenazine capsule) once daily for 6 weeks.
166752|NCT01688037|E5|Reported Event|Follow-Up|Participants who completed the open-label period entered the 4-week follow-up period.
166677|NCT01688336|O1|Outcome|FOLFIRINOX|"FOLFIRINOX given to all subjects~FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:~Oxaliplatin (85 mg/m2)~Leucovorin (400mg/ m2)~Irinotecan (180 mg/m2)~5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours"
166678|NCT01688336|O1|Outcome|FOLFIRINOX|"FOLFIRINOX given to all subjects~FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:~Oxaliplatin (85 mg/m2)~Leucovorin (400mg/ m2)~Irinotecan (180 mg/m2)~5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours"
166679|NCT01688336|E1|Reported Event|FOLFIRINOX|"FOLFIRINOX given to all subjects~FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:~Oxaliplatin (85 mg/m2)~Leucovorin (400mg/ m2)~Irinotecan (180 mg/m2)~5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours"
166680|NCT01688310|B3|Baseline|Total|Total of all reporting groups
166681|NCT01688310|B2|Baseline|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
166682|NCT01688310|B1|Baseline|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
166683|NCT01688310|P2|Participant Flow|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
166684|NCT01688310|P1|Participant Flow|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
166685|NCT01688310|O2|Outcome|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
166686|NCT01688310|O1|Outcome|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
166687|NCT01688310|O2|Outcome|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
166688|NCT01688310|O1|Outcome|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
166689|NCT01688310|O2|Outcome|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
166690|NCT01688310|O1|Outcome|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
166691|NCT01688310|O2|Outcome|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
166692|NCT01688310|O1|Outcome|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
166693|NCT01688310|O2|Outcome|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
166694|NCT01688310|O1|Outcome|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
166695|NCT01688310|O2|Outcome|Junior Physicians|Physicians who had very limited prior experience performing open surgical circumcisions.
166696|NCT01688310|O1|Outcome|Senior Physicians|Physicians who had extensive prior experience performing open surgical circumcisions.
166697|NCT01688310|O2|Outcome|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
166698|NCT01688310|O1|Outcome|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
166699|NCT01688310|E2|Reported Event|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
166700|NCT01688310|E1|Reported Event|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
166701|NCT01688102|B3|Baseline|Total|Total of all reporting groups
166702|NCT01688102|B2|Baseline|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
166703|NCT01688102|B1|Baseline|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
166753|NCT01688037|E4|Reported Event|Open-Label 50mg|Open-Label Period: Participants who completed the double-blind period entered the open-label period to receive valbenazine 50mg capsule for an additional 6 weeks of treatment.
166704|NCT01688102|P2|Participant Flow|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
166705|NCT01688102|P1|Participant Flow|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
166706|NCT01688102|O2|Outcome|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
166707|NCT01688102|O1|Outcome|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
166708|NCT01688102|O2|Outcome|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
166709|NCT01688102|O1|Outcome|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
166710|NCT01688102|O2|Outcome|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
166711|NCT01688102|O1|Outcome|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
166712|NCT01688102|O2|Outcome|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
166713|NCT01688102|O1|Outcome|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
166714|NCT01688102|O2|Outcome|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
166715|NCT01688102|O1|Outcome|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
166716|NCT01688102|O2|Outcome|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
166717|NCT01688102|O1|Outcome|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
166718|NCT01688102|O2|Outcome|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
166719|NCT01688102|O1|Outcome|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
166720|NCT01688102|O2|Outcome|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
166721|NCT01688102|O1|Outcome|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
166722|NCT01688102|O2|Outcome|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
166723|NCT01688102|O1|Outcome|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
166724|NCT01688102|O2|Outcome|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
166725|NCT01688102|O1|Outcome|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
166726|NCT01688102|O2|Outcome|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
166727|NCT01688102|O1|Outcome|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
166728|NCT01688102|O2|Outcome|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
166729|NCT01688102|O1|Outcome|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
166730|NCT01688102|E2|Reported Event|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
166731|NCT01688102|E1|Reported Event|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
166732|NCT01688050|B1|Baseline|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft: Zenith® TX2® Low Profile Endovascular Graft
166733|NCT01688050|P1|Participant Flow|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft: Zenith® TX2® Low Profile Endovascular Graft
166734|NCT01688050|O1|Outcome|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft: Zenith® TX2® Low Profile Endovascular Graft
166735|NCT01688050|O1|Outcome|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft: Zenith® TX2® Low Profile Endovascular Graft
166736|NCT01688050|O1|Outcome|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft: Zenith® TX2® Low Profile Endovascular Graft
166737|NCT01688050|E1|Reported Event|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft: Zenith® TX2® Low Profile Endovascular Graft
166738|NCT01688037|B4|Baseline|Total|Total of all reporting groups
166739|NCT01688037|B3|Baseline|Double-Blind 100mg/50mg, Then Open-Label 50mg|"Double-Blind Period: Participants first received valbenazine 100mg capsule once daily for 2 weeks, then they received valbenazine 50mg capsule once daily for 4 weeks.~Open-Label Period: Participants received valbenazine 50mg capsule once daily for 6 weeks."
166740|NCT01688037|B2|Baseline|Double-Blind 50mg, Then Open-Label 50mg|"Double-Blind Period: Participants first received valbenazine 50mg capsule once daily for 6 weeks.~Open-Label Period: Participants received valbenazine 50mg capsule once daily for 6 weeks."
166741|NCT01688037|B1|Baseline|Double-Blind Placebo, Then Open-Label 50mg|"Double-Blind Period: Participants first received Placebo capsule (matching valbenazine capsule) once daily for 6 weeks.~Open-Label Period: Participants received valbenazine 50mg capsule once daily for 6 weeks."
166742|NCT01688037|P3|Participant Flow|Double-Blind 100mg/50mg, Then Open-Label 50mg|"Double-Blind Period: Participants first received valbenazine 100mg capsule once daily for 2 weeks, then they received valbenazine 50mg capsule once daily for 4 weeks.~Open-Label Period: Participants received valbenazine 50mg capsule once daily for 6 weeks."
166743|NCT01688037|P2|Participant Flow|Double-Blind 50mg, Then Open-Label 50mg|"Double-Blind Period: Participants first received valbenazine 50mg capsule once daily for 6 weeks.~Open-Label Period: Participants received valbenazine 50mg capsule once daily for 6 weeks."
166744|NCT01688037|P1|Participant Flow|Double-Blind Placebo, Then Open-Label 50mg|"Double-Blind Period: Participants first received Placebo capsule (matching valbenazine capsule) once daily for 6 weeks.~Open-Label Period: Participants received valbenazine 50mg capsule once daily for 6 weeks."
166745|NCT01688037|O3|Outcome|Valbenazine 100mg|Participants received valbenazine 100mg capsule once daily for 2 weeks.
166746|NCT01688037|O2|Outcome|Valbenazine 50mg|Participants received valbenazine 50mg capsule once daily for 2 weeks.
166747|NCT01688037|O1|Outcome|Placebo|Participants received Placebo capsule (matching valbenazine capsule) once daily for 6 weeks.
166748|NCT01688037|O2|Outcome|Valbenazine 50mg and Valbenazine 100mg Then 50mg|Includes participants who received valbenazine 50mg capsule once daily for 6 weeks and participants who received valbenazine 100mg capsule once daily for 2 weeks, then 50mg capsule once daily for 4 weeks (a total of 6 weeks).
166749|NCT01688037|O1|Outcome|Placebo|Participants received Placebo capsule (matching valbenazine capsule) once daily for 6 weeks.
166750|NCT01688037|O2|Outcome|All Valbenazine|Includes participants who received valbenazine 50mg capsule once daily for 6 weeks and participants who received valbenazine 100mg capsule once daily for 2 weeks, then 50mg capsule once daily for 4 weeks (a total of 6 weeks).
166754|NCT01688037|E3|Reported Event|Double-Blind Placebo|Double-Blind Period: Participants received Placebo capsule (matching valbenazine capsule) once daily for 6 weeks.
166755|NCT01688037|E2|Reported Event|Double-Blind 100mg/50mg|Double-Blind Period: Participants received valbenazine 100mg capsule once daily for 2 weeks, then they received valbenazine 50mg capsule once daily for 4 weeks.
166756|NCT01688037|E1|Reported Event|Double-Blind 50mg|Double-Blind Period: Participants received valbenazine 50mg capsule once daily for 6 weeks.
166757|NCT01687998|B3|Baseline|Total|Total of all reporting groups
166758|NCT01687998|B2|Baseline|Placebo|Placebo, tablet administered orally once daily for up to 4 years. Participants received standard of care for HRVD.
166759|NCT01687998|B1|Baseline|Evacetrapib|Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants received standard of care for HRVD.
166760|NCT01687998|P2|Participant Flow|Placebo|Placebo, tablet administered orally once daily for up to 4 years. Participants will also receive standard of care for HRVD.
166761|NCT01687998|P1|Participant Flow|Evacetrapib|Evacetrapib 130 milligram (mg) tablet, administered orally once daily for up to 4 years. Participants will also receive standard of care for high-risk vascular disease (HRVD).
166762|NCT01687998|O2|Outcome|Placebo|Placebo, tablet administered orally once daily for up to 4 years. Participants received standard of care for HRVD.
166763|NCT01687998|O1|Outcome|Evacetrapib|Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants received standard of care for HRVD.
166764|NCT01687998|O2|Outcome|Placebo|Placebo, tablet administered orally once daily for up to 4 years. Participants received standard of care for HRVD.
166765|NCT01687998|O1|Outcome|Evacetrapib|Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants received standard of care for HRVD.
166766|NCT01687998|O2|Outcome|Placebo|Placebo, tablet administered orally once daily for up to 4 years. Participants received standard of care for HRVD.
166767|NCT01687998|O1|Outcome|Evacetrapib|Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants received standard of care for HRVD.
166768|NCT01687998|O2|Outcome|Placebo|Placebo, tablet administered orally once daily for up to 4 years. Participants received standard of care for HRVD.
166769|NCT01687998|O1|Outcome|Evacetrapib|Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants received standard of care for HRVD.
166770|NCT01687998|O2|Outcome|Placebo|Placebo, tablet administered orally once daily for up to 4 years. Participants received standard of care for HRVD.
166771|NCT01687998|O1|Outcome|Evacetrapib|Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants received standard of care for HRVD.
166772|NCT01687998|O2|Outcome|Placebo|Placebo, tablet administered orally once daily for up to 4 years. Participants received standard of care for HRVD.
166773|NCT01687998|O1|Outcome|Evacetrapib|Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants received standard of care for HRVD.
166774|NCT01687998|E2|Reported Event|Placebo|Placebo, tablet administered orally once daily for up to 4 years. Participants received standard of care for HRVD.
166775|NCT01687998|E1|Reported Event|Evacetrapib|Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants received standard of care for HRVD.
166776|NCT01687972|B3|Baseline|Total|Total of all reporting groups
166777|NCT01687972|B2|Baseline|Insorb Staples|Insorb absorbable staples: Placement of Insorb absorbable staples at cesarean section
166778|NCT01687972|B1|Baseline|Sutures|Absorbable sutures: placement of absorbable sutures at cesarean section
166779|NCT01687972|P2|Participant Flow|Insorb Staples|Insorb absorbable staples: Placement of Insorb absorbable staples at cesarean section
166780|NCT01687972|P1|Participant Flow|Sutures|Absorbable sutures: placement of absorbable sutures at cesarean section
166781|NCT01687972|O2|Outcome|Insorb Staples|Insorb absorbable staples: Placement of Insorb absorbable staples at cesarean section
166782|NCT01687972|O1|Outcome|Sutures|Absorbable sutures: placement of absorbable sutures at cesarean section
166783|NCT01687972|O2|Outcome|Insorb Staples|Insorb absorbable staples: Placement of Insorb absorbable staples at cesarean section
166784|NCT01687972|O1|Outcome|Sutures|Absorbable sutures: placement of absorbable sutures at cesarean section
166785|NCT01687972|O2|Outcome|Insorb Staples|Insorb absorbable staples: Placement of Insorb absorbable staples at cesarean section
166786|NCT01687972|O1|Outcome|Sutures|Absorbable sutures: placement of absorbable sutures at cesarean section
166787|NCT01687972|E2|Reported Event|Insorb Staples|Insorb absorbable staples: Placement of Insorb absorbable staples at cesarean section
166788|NCT01687972|E1|Reported Event|Sutures|Absorbable sutures: placement of absorbable sutures at cesarean section
166789|NCT01687790|B1|Baseline|Molecular Breast Imaging|molecular breast imaging (Discovery)
166790|NCT01687790|P1|Participant Flow|Molecular Breast Imaging|molecular breast imaging (Discovery)
166791|NCT01687790|O1|Outcome|Molecular Breast Imaging|molecular breast imaging (Discovery)
166792|NCT01687790|O1|Outcome|Molecular Breast Imaging|Participants received molecular breast imaging before biopsy
166793|NCT01687790|E1|Reported Event|Molecular Breast Imaging|molecular breast imaging (Discovery)
166794|NCT01687712|B3|Baseline|Total|Total of all reporting groups
166795|NCT01687712|B2|Baseline|Gonal-f® RFF|One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166796|NCT01687712|B1|Baseline|AFOLIA|One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166797|NCT01687712|P2|Participant Flow|Gonal-f® RFF|One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166798|NCT01687712|P1|Participant Flow|AFOLIA|One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166799|NCT01687712|O2|Outcome|Gonal-f® RFF|One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166800|NCT01687712|O1|Outcome|AFOLIA|One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166801|NCT01687712|O2|Outcome|Gonal-f® RFF|One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166802|NCT01687712|O1|Outcome|AFOLIA|One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166803|NCT01687712|O2|Outcome|Gonal-f® RFF|One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166804|NCT01687712|O1|Outcome|AFOLIA|One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166805|NCT01687712|O2|Outcome|Gonal-f® RFF|One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166806|NCT01687712|O1|Outcome|AFOLIA|One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166807|NCT01687712|O2|Outcome|Gonal-f® RFF|One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166808|NCT01687712|O1|Outcome|AFOLIA|One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166809|NCT01687712|O2|Outcome|Gonal-f® RFF|One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166810|NCT01687712|O1|Outcome|AFOLIA|One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166811|NCT01687712|O2|Outcome|Gonal-f® RFF|One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166812|NCT01687712|O1|Outcome|AFOLIA|One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166813|NCT01687712|O2|Outcome|Gonal-f® RFF|One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166814|NCT01687712|O1|Outcome|AFOLIA|One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166815|NCT01687712|O2|Outcome|Gonal-f® RFF|One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166816|NCT01687712|O1|Outcome|AFOLIA|One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166817|NCT01687712|O2|Outcome|Gonal-f® RFF|One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166818|NCT01687712|O1|Outcome|AFOLIA|One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166819|NCT01687712|O2|Outcome|Gonal-f® RFF|One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166820|NCT01687712|O1|Outcome|AFOLIA|One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166821|NCT01687712|O2|Outcome|Gonal-f® RFF|One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166822|NCT01687712|O1|Outcome|AFOLIA|One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166823|NCT01687712|O2|Outcome|Gonal-f® RFF|One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166850|NCT01687478|O2|Outcome|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.~Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
166824|NCT01687712|O1|Outcome|AFOLIA|One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166825|NCT01687712|O2|Outcome|Gonal-f® RFF|One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166826|NCT01687712|O1|Outcome|AFOLIA|One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166827|NCT01687712|O2|Outcome|Gonal-f® RFF|One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166828|NCT01687712|O1|Outcome|AFOLIA|One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166829|NCT01687712|E6|Reported Event|Gonal-f® RFF - Cycle 3|Enrolled subjects in Cycle 3 were randomized to one subcutaneous injection of 225IU Gonal-f (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166830|NCT01687712|E5|Reported Event|AFOLIA - Cycle 3|Enrolled subjects in Cycle 3 were randomized to one subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166831|NCT01687712|E4|Reported Event|Gonal-f® RFF - Cycle 2|Enrolled subjects in Cycle 2 were randomized to one subcutaneous injection of 225IU Gonal-f (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166832|NCT01687712|E3|Reported Event|AFOLIA - Cycle 2|Enrolled subjects in Cycle 2 were randomized to one subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166833|NCT01687712|E2|Reported Event|Gonal-f® RFF - Cycle 1|Enrolled subjects in Cycle 1 were randomized to one subcutaneous injection of 225IU Gonal-f (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166834|NCT01687712|E1|Reported Event|AFOLIA - Cycle 1|Enrolled subjects in Cycle 1 were randomized to one subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
166835|NCT01687478|B3|Baseline|Total|Total of all reporting groups
166836|NCT01687478|B2|Baseline|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.~Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
166837|NCT01687478|B1|Baseline|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.~Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
166838|NCT01687478|P2|Participant Flow|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.~Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
166839|NCT01687478|P1|Participant Flow|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.~Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
166840|NCT01687478|O2|Outcome|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.~Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
166841|NCT01687478|O1|Outcome|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.~Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
166842|NCT01687478|O2|Outcome|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.~Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
166843|NCT01687478|O1|Outcome|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.~Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
166844|NCT01687478|O2|Outcome|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.~Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
166845|NCT01687478|O1|Outcome|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.~Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
166846|NCT01687478|O2|Outcome|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.~Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
166847|NCT01687478|O1|Outcome|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.~Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
166848|NCT01687478|O2|Outcome|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.~Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
166849|NCT01687478|O1|Outcome|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.~Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
168656|NCT01681576|O2|Outcome|Valsartan - ALL|Valsartan 320mg QD
166851|NCT01687478|O1|Outcome|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.~Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
166852|NCT01687478|O2|Outcome|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.~Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
166853|NCT01687478|O1|Outcome|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.~Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
166854|NCT01687478|O2|Outcome|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.~Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
166855|NCT01687478|O1|Outcome|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.~Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
166856|NCT01687478|O2|Outcome|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.~Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
166857|NCT01687478|O1|Outcome|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.~Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
166858|NCT01687478|E2|Reported Event|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.~Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
166859|NCT01687478|E1|Reported Event|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.~Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
166860|NCT01687296|B3|Baseline|Total|Total of all reporting groups
166861|NCT01687296|B2|Baseline|Prednisone|Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
166862|NCT01687296|B1|Baseline|Fluticasone Propionate|Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
166863|NCT01687296|P2|Participant Flow|Prednisone|Participants received oral prednisone tablets once daily at 2 mg per kilogram (kg) per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
166864|NCT01687296|P1|Participant Flow|Fluticasone Propionate|Participants received fluticasone propionate inhalation solution twice daily (BID) 2x0.5 milligrams (mg)/millilitres (mL) via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
166865|NCT01687296|O2|Outcome|Prednisone|Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
166866|NCT01687296|O1|Outcome|Fluticasone Propionate|Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
166867|NCT01687296|O2|Outcome|Prednisone|Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
166868|NCT01687296|O1|Outcome|Fluticasone Propionate|Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
166869|NCT01687296|O2|Outcome|Prednisone|Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
166870|NCT01687296|O1|Outcome|Fluticasone Propionate|Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
166871|NCT01687296|O2|Outcome|Prednisone|Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
166872|NCT01687296|O1|Outcome|Fluticasone Propionate|Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
166873|NCT01687296|O2|Outcome|Prednisone|Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
166874|NCT01687296|O1|Outcome|Fluticasone Propionate|Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
166875|NCT01687296|O2|Outcome|Prednisone|Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
166876|NCT01687296|O1|Outcome|Fluticasone Propionate|Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
166877|NCT01687296|O2|Outcome|Prednisone|Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
166878|NCT01687296|O1|Outcome|Fluticasone Propionate|Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
166879|NCT01687296|O2|Outcome|Prednisone|Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
166880|NCT01687296|O1|Outcome|Fluticasone Propionate|Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
166881|NCT01687296|E2|Reported Event|Prednisone|Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
166882|NCT01687296|E1|Reported Event|Fluticasone Propionate|Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.
166883|NCT01687283|B3|Baseline|Total|Total of all reporting groups
166884|NCT01687283|B2|Baseline|BUD 2 mg BID|Participants received BUD oral suspension for inhalation 2 mg BID via nebulizer for a treatment period of 12 weeks participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
166885|NCT01687283|B1|Baseline|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
166886|NCT01687283|P2|Participant Flow|BUD 2 mg BID|Participants received Budesonide (BUD) oral suspension for inhalation 2 mg BID via nebulizer for a treatment period of 12 weeks participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
166887|NCT01687283|P1|Participant Flow|FP 1 mg BID|Participants received Fluticasone propionate (FP) oral inhalation (inhal) solution (sol'n) 1 milligram (mg) twice daily (BID) via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
166888|NCT01687283|O1|Outcome|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
166889|NCT01687283|O1|Outcome|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
166890|NCT01687283|O1|Outcome|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
166891|NCT01687283|O2|Outcome|BUD 2 mg BID|Participants received BUD oral suspension for inhalation 2 mg BID via nebulizer for a treatment period of 12 weeks participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
166892|NCT01687283|O1|Outcome|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
166893|NCT01687283|O2|Outcome|BUD 2 mg BID|Participants received BUD oral suspension for inhalation 2 mg BID via nebulizer for a treatment period of 12 weeks participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
166894|NCT01687283|O1|Outcome|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
166970|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
166895|NCT01687283|O2|Outcome|BUD 2 mg BID|Participants received BUD oral suspension for inhalation 2 mg BID via nebulizer for a treatment period of 12 weeks participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
166896|NCT01687283|O1|Outcome|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
166897|NCT01687283|O2|Outcome|BUD 2 mg BID|Participants received BUD oral suspension for inhalation 2 mg BID via nebulizer for a treatment period of 12 weeks participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
166898|NCT01687283|O1|Outcome|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
166899|NCT01687283|O2|Outcome|BUD 2 mg BID|Participants received BUD oral suspension for inhalation 2 mg BID via nebulizer for a treatment period of 12 weeks participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
166900|NCT01687283|O1|Outcome|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
166901|NCT01687283|O2|Outcome|BUD 2 mg BID|Participants received BUD oral suspension for inhalation 2 mg BID via nebulizer for a treatment period of 12 weeks participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
166902|NCT01687283|O1|Outcome|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
166903|NCT01687283|O2|Outcome|BUD 2 mg BID|Participants received BUD oral suspension for inhalation 2 mg BID via nebulizer for a treatment period of 12 weeks participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
166904|NCT01687283|O1|Outcome|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
166905|NCT01687283|O2|Outcome|BUD 2 mg BID|Participants received BUD oral suspension for inhalation 2 mg BID via nebulizer for a treatment period of 12 weeks participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
166906|NCT01687283|O1|Outcome|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
166907|NCT01687283|E2|Reported Event|BUD 2 mg BID|Participants received BUD oral suspension for inhalation 2 mg BID via nebulizer for a treatment period of 12 weeks participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
166908|NCT01687283|E1|Reported Event|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
166909|NCT01687270|B1|Baseline|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
166910|NCT01687270|P1|Participant Flow|SOF+RBV|Sofosbuvir (SOF) 400 mg tablet once daily plus ribavirin (RBV) tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
166911|NCT01687270|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
166912|NCT01687270|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
166913|NCT01687270|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
166914|NCT01687270|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
166915|NCT01687270|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
166916|NCT01687270|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
166917|NCT01687270|E1|Reported Event|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
166918|NCT01687257|B3|Baseline|Total|Total of all reporting groups
166919|NCT01687257|B2|Baseline|SOF+RBV (Group 2; Received Treatment)|This reporting group includes participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks.
166920|NCT01687257|B1|Baseline|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
166921|NCT01687257|P3|Participant Flow|Observation/SOF+RBV (Group 2; Received Treatment)|This reporting group includes participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks.
166922|NCT01687257|P2|Participant Flow|Observation/SOF+RBV (Group 2; Not Treated)|This reporting group only includes participants who were randomized to the Observation/SOF+RBV group who discontinued study prior to receiving study drug.
166923|NCT01687257|P1|Participant Flow|SOF+RBV (Group 1)|Sofosbuvir (Sovaldi®; SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
166924|NCT01687257|O4|Outcome|All SOF+RBV (Groups 1 and 2)|Participants who received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks in both Groups 1 and 2
166925|NCT01687257|O3|Outcome|SOF+RBV (Group 2)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for up to 48 weeks
166926|NCT01687257|O2|Outcome|Observation Period (Group 2)|24 weeks of observation
166971|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
166927|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for up to 48 weeks
166928|NCT01687257|O4|Outcome|All SOF+RBV (Groups 1 and 2)|Participants who received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks in both Groups 1 and 2
166929|NCT01687257|O3|Outcome|SOF+RBV (Group 2)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for up to 48 weeks
166930|NCT01687257|O2|Outcome|Observation Period (Group 2)|24 weeks of observation
166931|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for up to 48 weeks
166932|NCT01687257|O4|Outcome|All SOF+RBV (Groups 1 and 2)|Participants who received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 48 weeks in both Groups 1 and 2
166933|NCT01687257|O3|Outcome|SOF+RBV (Group 2)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 48 weeks
166934|NCT01687257|O2|Outcome|Observation Period (Group 2)|24 weeks of observation
166935|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for up to 48 weeks
166936|NCT01687257|O2|Outcome|SOF+RBV (Group 2)|Participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
166937|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
166938|NCT01687257|O2|Outcome|SOF+RBV (Group 2)|Participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
166939|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
166940|NCT01687257|O2|Outcome|SOF+RBV (Group 2)|Participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
166941|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
166942|NCT01687257|O3|Outcome|SOF+RBV (Group 2)|Participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
166943|NCT01687257|O2|Outcome|Observation Period (Group 2)|24 weeks of observation
166944|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
166945|NCT01687257|E3|Reported Event|SOF+RBV Treatment Only (Group 2)|This reporting group includes participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks.
166946|NCT01687257|E2|Reported Event|Observation Period Only (Group 2)|This reporting group includes participants who were randomized to the Observation/SOF+RBV group and received up to 24 weeks of observation.
166947|NCT01687257|E1|Reported Event|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
166948|NCT01687244|B3|Baseline|Total|Total of all reporting groups
166949|NCT01687244|B2|Baseline|rAd-IFN Dose 3x10^11 Vps/ml|Patients were randomly assigned to the 3x10^11vps/ml of rAd-IFN/Syn3 arm.
166950|NCT01687244|B1|Baseline|rAd-IFN Dose 1x10^11vps/ml|Patients were randomly assigned to the 1x10^11vps/ml of rAd-IFN/Syn3 arm.
166951|NCT01687244|P2|Participant Flow|rAd-IFN Dose 3x10^11 Vps/ml|"Patients were randomized to the 3x10^11vps/ml rAd-IFN/Syn3 arm.~A 75 mL dose of rAd-IFN/Syn3 was given as a single, one-hour intravesical administration and, depending on clinical response, was repeated every 90 Days up to a maximum of 4 instilations."
166952|NCT01687244|P1|Participant Flow|rAd-IFN Dose 1x10^11vps/ml|"Patients were randomized to the 1x10^11vps/ml rAd-IFN/Syn3 arm.~A 75 mL dose of rAd-IFN/Syn3 was given as a single, one-hour intravesical administration and, depending on clinical response, was repeated every 90 Days up to a maximum of 4 instilations."
166953|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/mL|Patients were randomly assigned to the 3x10^11 vps/ml rAd-IFN/Syn3 arm.
166954|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11vps/ml|Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
166955|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
166956|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
166957|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
166958|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11vps/ml|Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
166959|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
166960|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomly assigned to the 1x10^11 vps/mI rAd-IFN/Syn3 arm.
166961|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
166962|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomly assigned to the 1x10^11 vps/mI rAd-IFN/Syn3 arm.
166963|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
166964|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11vps/ml|Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
166965|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Subjects were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
166966|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomly assigned to the 1x10^11 vps/mI rAd-IFN/Syn3 arm.
166967|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
166968|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11vps/ml|Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
166969|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
166974|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
166975|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11 Vps/ml|Patients were randomly assigned to the 3x10^11 vps/ml rAd-IFN/Syn3 arm.
166976|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11vps/ml|Patients were randomly assigned to the 1x10^11vps/ml rAd-IFN/Syn3 arm.
166977|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
166978|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Subjects were randomly assigned to the 1x10^11 vps/mI rAd-IFN/Syn3 arm.
166979|NCT01687244|E2|Reported Event|rAd-IFN Dose 3x10^11vps/ml|Patients were randomized the 3x10^11 vps/ml INSTILADRIN arm.
166980|NCT01687244|E1|Reported Event|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomized to the 1x10^11 vps/ml INSTILADRIN arm.
166981|NCT01687218|B7|Baseline|Total|Total of all reporting groups
166982|NCT01687218|B6|Baseline|Group 6|"Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks);followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
166983|NCT01687218|B5|Baseline|Group 5|"Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
166984|NCT01687218|B4|Baseline|Group 4|"Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
166985|NCT01687218|B3|Baseline|Group 3|"Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
166986|NCT01687218|B2|Baseline|Group 2|"Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
166987|NCT01687218|B1|Baseline|Group 1|"Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
166988|NCT01687218|P6|Participant Flow|Group 6|"Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks);followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
166989|NCT01687218|P5|Participant Flow|Group 5|"Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
166990|NCT01687218|P4|Participant Flow|Group 4|"Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
166991|NCT01687218|P3|Participant Flow|Group 3|"Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
166992|NCT01687218|P2|Participant Flow|Group 2|"Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
167100|NCT01686646|P4|Participant Flow|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
166993|NCT01687218|P1|Participant Flow|Group 1|"Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
166994|NCT01687218|O3|Outcome|Product 3|Rectal (RAI-associated TFV RG 1% gel)
166995|NCT01687218|O2|Outcome|Product 2|Rectal (Daily TFV RG 1% gel)
166996|NCT01687218|O1|Outcome|Product 1|Oral (Daily FTC/TDF)
166997|NCT01687218|O3|Outcome|Product 3|Rectal (RAI-associated TFV RG 1% gel)
166998|NCT01687218|O2|Outcome|Product 2|Rectal (Daily TFV RG 1% gel)
166999|NCT01687218|O1|Outcome|Product 1|Oral (Daily FTC/TDF)
167000|NCT01687218|O3|Outcome|Product 3|Rectal (RAI-associated TFV RG 1% gel)
167001|NCT01687218|O2|Outcome|Product 2|Rectal (Daily TFV RG 1% gel)
167002|NCT01687218|O1|Outcome|Product 1|Oral (Daily FTC/TDF)
167003|NCT01687218|O3|Outcome|Product 3|Rectal (RAI-associated TFV RG 1% gel)
167004|NCT01687218|O2|Outcome|Product 2|Rectal (Daily TFV RG 1% gel)
167005|NCT01687218|O1|Outcome|Product 1|Oral (Daily FTC/TDF)
167006|NCT01687218|O3|Outcome|Product 3|Rectal (RAI-associated TFV RG 1% gel)
167007|NCT01687218|O2|Outcome|Product 2|Rectal (Daily TFV RG 1% gel)
167008|NCT01687218|O1|Outcome|Product 1|Oral (Daily FTC/TDF)
167009|NCT01687218|E3|Reported Event|Product 3|Rectal (RAI-associated TFV RG 1% gel)
167010|NCT01687218|E2|Reported Event|Product 2|Rectal (Daily TFV RG 1% gel)
167011|NCT01687218|E1|Reported Event|Product 1|Oral (Daily FTC/TDF)
167012|NCT01687114|B1|Baseline|Cranberry Juice|"27% cranberry juice~cranberry juice: 27% cranberry juice"
167013|NCT01687114|P1|Participant Flow|Cranberry Juice|"27% cranberry juice~cranberry juice: 27% cranberry juice"
167014|NCT01687114|O1|Outcome|Cranberry Juice|"27% cranberry juice~cranberry juice: 27% cranberry juice"
167015|NCT01687114|E1|Reported Event|Cranberry Juice|"27% cranberry juice~cranberry juice: 27% cranberry juice"
167016|NCT01687101|B1|Baseline|STOPAIN Topical Gel|STOPAIN gel which is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.
167017|NCT01687101|P1|Participant Flow|STOPAIN Topical Gel|STOPAIN gel which is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.
167018|NCT01687101|O1|Outcome|STOPAIN Topical Gel|STOPAIN gel which is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.
167019|NCT01687101|E1|Reported Event|STOPAIN Topical Gel|STOPAIN gel which is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.
167020|NCT01687088|B3|Baseline|Total|Total of all reporting groups
167021|NCT01687088|B2|Baseline|Controls|No significant headache or disability as defined by migraine disability scale.
167022|NCT01687088|B1|Baseline|Chronic Migraineurs|At least 8 migraine days per week and headache at least 15 days per month.
167023|NCT01687088|P2|Participant Flow|Controls|No significant headache or disability as defined by migraine disability scale.
167024|NCT01687088|P1|Participant Flow|Chronic Migraineurs|At least 8 migraine days per week and headache at least 15 days per month.
167025|NCT01687088|O2|Outcome|Controls|No significant headache or disability as defined by migraine disability scale.
167026|NCT01687088|O1|Outcome|Chronic Migraineurs|At least 8 migraine days per week and headache at least 15 days per month.
167027|NCT01687088|E2|Reported Event|Controls|No significant headache or disability as defined by migraine disability scale.
167028|NCT01687088|E1|Reported Event|Chronic Migraineurs|At least 8 migraine days per week and headache at least 15 days per month.
167029|NCT01687036|B1|Baseline|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
167030|NCT01687036|P1|Participant Flow|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System (single treatment during visit 3)."
167031|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
167032|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
167033|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
167034|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
167035|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
167036|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
167037|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
167038|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
167039|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
167040|NCT01687036|E1|Reported Event|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
167041|NCT01686932|B3|Baseline|Total|Total of all reporting groups
167042|NCT01686932|B2|Baseline|Sitagliptin Followed by Vildagliptin|Period 1: sitagliptin 100mg QD for 8 weeks; followed by Washout then Period 2: vildagliptin 50mg BID for 8 weeks
167043|NCT01686932|B1|Baseline|Vildagliptin Followed by Sitagliptin|Period 1: vildagliptin 50mg BID for 8 weeks; followed by Washout then Period 2: sitagliptin 100mg QD for 8 weeks
167044|NCT01686932|P2|Participant Flow|Sitagliptin Followed by Vildagliptin|Period 1: sitagliptin 100mg QD for 8 weeks; followed by Washout then Period 2: vildagliptin 50mg BID for 8 weeks
167045|NCT01686932|P1|Participant Flow|Vildagliptin Followed by Sitagliptin|Period 1: vildagliptin 50mg BID for 8 weeks; followed by Washout then Period 2: sitagliptin 100mg QD for 8 weeks
167046|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
167047|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
167048|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
167049|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
167050|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
167051|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
167052|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
167053|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
167054|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
167055|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
167056|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
167057|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
167058|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
167059|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
167060|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
167061|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
167062|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
167063|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
167064|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
167065|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
167066|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
167067|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
167068|NCT01686932|E2|Reported Event|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
167069|NCT01686932|E1|Reported Event|Vildagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
167070|NCT01686828|B5|Baseline|Total|Total of all reporting groups
167071|NCT01686828|B4|Baseline|Acyline & Testosterone Gel & Letrozole|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone transdermal 1.62% gel (5g) daily + letrozole (5mg) aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Letrozole: Letrozole oral aromatase inhibitor 5mg daily for 4 weeks"
167072|NCT01686828|B3|Baseline|Acyline & Testosterone Gel 5g/d & Placebo Pill|"Acyline (300mcg/kg every 2 weeks, by injections) + Testosterone 1.62% gel (5g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
167073|NCT01686828|B2|Baseline|Acyline & Testosterone Gel 1.25g/d & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone 1.62% gel (1.25g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
167074|NCT01686828|B1|Baseline|Acyline & Placebo Gel & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + placebo transdermal gel + placebo aromatase inhibitor daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Placebo gel (for Testosterone 1.62% gel): placebo gel manufactured to mimic Testosterone 1.62% gel~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
167075|NCT01686828|P4|Participant Flow|Acyline & Testosterone Gel & Letrozole|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone transdermal 1.62% gel (5g) daily + letrozole (5mg) aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Letrozole: Letrozole oral aromatase inhibitor 5mg daily for 4 weeks"
167076|NCT01686828|P3|Participant Flow|Acyline & Testosterone Gel 5g/d & Placebo Pill|"Acyline (300mcg/kg every 2 weeks, by injections) + Testosterone 1.62% gel (5g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
167077|NCT01686828|P2|Participant Flow|Acyline & Testosterone Gel 1.25g/d & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone 1.62% gel (1.25g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
167078|NCT01686828|P1|Participant Flow|Acyline & Placebo Gel & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + placebo transdermal gel + placebo aromatase inhibitor daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Placebo gel (for Testosterone 1.62% gel): placebo gel manufactured to mimic Testosterone 1.62% gel~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
168657|NCT01681576|O1|Outcome|LCZ696 - ALL|LCZ696 400mg
167079|NCT01686828|O4|Outcome|Acyline + Testosterone Gel (5g/d) + Letrozole|Acyline (300 mcg/kg, subcutaneous injection at weeks 0, 2) + testosterone gel administered daily + daily letrozole (pills). This group was intended to have normal levels of serum testosterone with selective estrogen deficiency.
167080|NCT01686828|O3|Outcome|Acyline + Testosterone Gel (5g/d) + Placebo Pills|Acyline (300 mcg/kg, subcutaneous injection at weeks 0, 2) + testosterone gel administered daily + daily placebo pills. This group was intended to have normal, physiologic levels of serum testosterone and estradiol.
167081|NCT01686828|O2|Outcome|Acyline + Testosterone Gel (1.25g/d) + Placebo Pills|Acyline (300 mcg/kg, subcutaneous injection at weeks 0, 2) + testosterone gel administered daily + daily placebo pills. This group was intended to have low-normal levels of serum testosterone and estradiol.
167082|NCT01686828|O1|Outcome|Acyline + Placebo Gel + Placebo Pills|Acyline (300 mg/kg, subcutaneous injection at weeks 0, 2) + placebo gel + oral placebo pills daily. This treatment regimen resulted in medical castration.
167083|NCT01686828|O4|Outcome|Acyline & Testosterone Gel & Letrozole|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone transdermal 1.62% gel (5g) daily + letrozole (5mg) aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Letrozole: Letrozole oral aromatase inhibitor 5mg daily for 4 weeks"
167084|NCT01686828|O3|Outcome|Acyline & Testosterone Gel 5g/d & Placebo Pill|"Acyline (300mcg/kg every 2 weeks, by injections) + Testosterone 1.62% gel (5g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
167085|NCT01686828|O2|Outcome|Acyline & Testosterone Gel 1.25g/d & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone 1.62% gel (1.25g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
167086|NCT01686828|O1|Outcome|Acyline & Placebo Gel & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + placebo transdermal gel + placebo aromatase inhibitor daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Placebo gel (for Testosterone 1.62% gel): placebo gel manufactured to mimic Testosterone 1.62% gel~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
167087|NCT01686828|O4|Outcome|Acyline & Testosterone Gel & Letrozole|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone transdermal 1.62% gel (5g) daily + letrozole (5mg) aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Letrozole: Letrozole oral aromatase inhibitor 5mg daily for 4 weeks"
167088|NCT01686828|O3|Outcome|Acyline & Testosterone Gel 5g/d & Placebo Pill|"Acyline (300mcg/kg every 2 weeks, by injections) + Testosterone 1.62% gel (5g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
167089|NCT01686828|O2|Outcome|Acyline & Testosterone Gel 1.25g/d & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone 1.62% gel (1.25g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
167090|NCT01686828|O1|Outcome|Acyline & Placebo Gel & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + placebo transdermal gel + placebo aromatase inhibitor daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Placebo gel (for Testosterone 1.62% gel): placebo gel manufactured to mimic Testosterone 1.62% gel~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
167091|NCT01686828|E4|Reported Event|Acyline & Testosterone Gel & Letrozole|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone transdermal 1.62% gel (5g) daily + letrozole (5mg) aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Letrozole: Letrozole oral aromatase inhibitor 5mg daily for 4 weeks"
167092|NCT01686828|E3|Reported Event|Acyline & Testosterone Gel 5g/d & Placebo Pill|"Acyline (300mcg/kg every 2 weeks, by injections) + Testosterone 1.62% gel (5g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
167093|NCT01686828|E2|Reported Event|Acyline & Testosterone Gel 1.25g/d & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone 1.62% gel (1.25g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
167094|NCT01686828|E1|Reported Event|Acyline & Placebo Gel & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + placebo transdermal gel + placebo aromatase inhibitor daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Placebo gel (for Testosterone 1.62% gel): placebo gel manufactured to mimic Testosterone 1.62% gel~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
167095|NCT01686646|B5|Baseline|Total|Total of all reporting groups
167096|NCT01686646|B4|Baseline|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
167097|NCT01686646|B3|Baseline|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
167098|NCT01686646|B2|Baseline|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
167099|NCT01686646|B1|Baseline|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
167262|NCT01685996|E2|Reported Event|Placebo|"Participants will receive placebo capsules to take once a day~placebo"
167101|NCT01686646|P3|Participant Flow|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
167102|NCT01686646|P2|Participant Flow|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
167103|NCT01686646|P1|Participant Flow|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 milligrams [mg] ) and caffeine (65 mg) tablets were dissolved in 200 milliliter (mL) of water and administered orally.
167104|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
167105|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
167106|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
167107|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
167108|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
167109|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
167110|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
167111|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
167112|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
167113|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
167114|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
167115|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
167116|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
167117|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
167118|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
167119|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
167120|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
167121|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
167122|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
167123|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
167124|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
167125|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
167126|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
167127|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
167128|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
167129|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
167130|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
167131|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
167132|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
167133|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
167134|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
167135|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
167136|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
167137|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
167138|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
167139|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
167140|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
167141|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
167142|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
167143|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
167144|NCT01686646|E4|Reported Event|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
167145|NCT01686646|E3|Reported Event|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
167146|NCT01686646|E2|Reported Event|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
167147|NCT01686646|E1|Reported Event|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
167148|NCT01686633|B4|Baseline|Total|Total of all reporting groups
167149|NCT01686633|B3|Baseline|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167150|NCT01686633|B2|Baseline|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167151|NCT01686633|B1|Baseline|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167152|NCT01686633|P3|Participant Flow|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167153|NCT01686633|P2|Participant Flow|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167154|NCT01686633|P1|Participant Flow|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder once daily (OD) in the evening from a dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167155|NCT01686633|O3|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167156|NCT01686633|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167157|NCT01686633|O1|Outcome|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167158|NCT01686633|O3|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167159|NCT01686633|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167160|NCT01686633|O1|Outcome|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167161|NCT01686633|O3|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167162|NCT01686633|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167163|NCT01686633|O1|Outcome|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167164|NCT01686633|O3|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167165|NCT01686633|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167166|NCT01686633|O1|Outcome|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167167|NCT01686633|O3|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167168|NCT01686633|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167169|NCT01686633|O1|Outcome|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167170|NCT01686633|O3|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167326|NCT01685801|O3|Outcome|Open-label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 8 weeks during the open-label period after washout period 2.
167171|NCT01686633|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167172|NCT01686633|O1|Outcome|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167173|NCT01686633|E3|Reported Event|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167174|NCT01686633|E2|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167175|NCT01686633|E1|Reported Event|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
167176|NCT01686568|B3|Baseline|Total|Total of all reporting groups
167177|NCT01686568|B2|Baseline|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
167178|NCT01686568|B1|Baseline|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
167179|NCT01686568|P2|Participant Flow|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
167180|NCT01686568|P1|Participant Flow|Omega-3|Patients in this group will receive oral supplementation with EPA + Docosahexaenoic acid (DHA) (3.9grams/day) for 6 months.
167181|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
167182|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
167183|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
167184|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
167185|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
167186|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
167187|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
167188|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
167189|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
167190|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
167191|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
167192|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
167193|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
167194|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
167195|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
167196|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
167197|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
167198|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
167199|NCT01686568|E2|Reported Event|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
167200|NCT01686568|E1|Reported Event|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
167201|NCT01686503|B5|Baseline|Total|Total of all reporting groups
167202|NCT01686503|B4|Baseline|2/5 Dose Intramuscular IPV|"Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
167203|NCT01686503|B3|Baseline|Full Dose Intramuscular IPV|"Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
167204|NCT01686503|B2|Baseline|1/5 Dose Intadermal IPV|"Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
167205|NCT01686503|B1|Baseline|2/5 Dose Intradermal IPV|"Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
167206|NCT01686503|P4|Participant Flow|2/5 Dose Intramuscular IPV|"Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
167412|NCT01685372|O2|Outcome|Fluzone Standard Dose|Fluzone: A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
167207|NCT01686503|P3|Participant Flow|Full Dose Intramuscular IPV|"Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
167208|NCT01686503|P2|Participant Flow|1/5 Dose Intadermal IPV|"Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
167209|NCT01686503|P1|Participant Flow|2/5 Dose Intradermal IPV|"Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
167210|NCT01686503|O4|Outcome|2/5 Dose Intramuscular IPV|"Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
167211|NCT01686503|O3|Outcome|Full Dose Intramuscular IPV|"Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
167212|NCT01686503|O2|Outcome|1/5 Dose Intadermal IPV|"Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
167213|NCT01686503|O1|Outcome|2/5 Dose Intradermal IPV|"Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
167214|NCT01686503|O4|Outcome|2/5 Dose Intramuscular IPV|"Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
167215|NCT01686503|O3|Outcome|Full Dose Intramuscular IPV|"Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
167216|NCT01686503|O2|Outcome|1/5 Dose Intadermal IPV|"Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
167217|NCT01686503|O1|Outcome|2/5 Dose Intradermal IPV|"Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
167218|NCT01686503|E4|Reported Event|2/5 Dose Intramuscular IPV|"Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
167219|NCT01686503|E3|Reported Event|Full Dose Intramuscular IPV|"Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
167220|NCT01686503|E2|Reported Event|1/5 Dose Intadermal IPV|"Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
167221|NCT01686503|E1|Reported Event|2/5 Dose Intradermal IPV|"Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
167222|NCT01686451|B3|Baseline|Total|Total of all reporting groups
167223|NCT01686451|B2|Baseline|XueZhiKang|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
167224|NCT01686451|B1|Baseline|Simvastatin|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
167225|NCT01686451|P2|Participant Flow|XueZhiKang|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
167226|NCT01686451|P1|Participant Flow|Simvastatin|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
167227|NCT01686451|O4|Outcome|XueZhiKang/Week 4|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
167228|NCT01686451|O3|Outcome|XueZhiKang/Baseline|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
167229|NCT01686451|O2|Outcome|Simvastatin/Week 4|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
167230|NCT01686451|O1|Outcome|Simvastatin/Baseline|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
167231|NCT01686451|O4|Outcome|XueZhiKang/Week 4|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
167232|NCT01686451|O3|Outcome|XueZhiKang/Baseline|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
167233|NCT01686451|O2|Outcome|Simvastatin/Week 4|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
167234|NCT01686451|O1|Outcome|Simvastatin/Baseline|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
167235|NCT01686451|O4|Outcome|XueZhiKang/Week 4|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
167236|NCT01686451|O3|Outcome|XueZhiKang/Baseline|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
167237|NCT01686451|O2|Outcome|Simvastatin/Week 4|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
167238|NCT01686451|O1|Outcome|Simvastatin/Baseline|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
167239|NCT01686451|O4|Outcome|XueZhiKang/Week 4|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
167240|NCT01686451|O3|Outcome|XueZhiKang/Baseline|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
167241|NCT01686451|O2|Outcome|Simvastatin/Week 4|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
167242|NCT01686451|O1|Outcome|Simvastatin/Baseline|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
167243|NCT01686451|O4|Outcome|XueZhiKang/Week 4|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
167244|NCT01686451|O3|Outcome|XueZhiKang/Baseline|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
167245|NCT01686451|O2|Outcome|Simvastatin/Week 4|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
167246|NCT01686451|O1|Outcome|Simvastatin/Baseline|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
167247|NCT01686451|O4|Outcome|XueZhiKang/Week 4|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
167248|NCT01686451|O3|Outcome|XueZhiKang/Baseline|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
167249|NCT01686451|O2|Outcome|Simvastatin/Week 4|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
167250|NCT01686451|O1|Outcome|Simvastatin/Baseline|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
167251|NCT01686451|E2|Reported Event|XueZhiKang|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
167252|NCT01686451|E1|Reported Event|Simvastatin|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
167253|NCT01685996|B3|Baseline|Total|Total of all reporting groups
167254|NCT01685996|B2|Baseline|Placebo|Participants receive placebo + varenicline for smoking cessation
167255|NCT01685996|B1|Baseline|Zonisamide|Participants receive zonisamide + varenicline for smoking cessation
167256|NCT01685996|P2|Participant Flow|Placebo|"Participants will receive placebo capsules to take once a day~placebo"
167257|NCT01685996|P1|Participant Flow|Zonisamide|"participants will receive zonisamide capsules (up to 300 mg) to take once a day.~zonisamide: In addition to zonisamide vs placebo treatment, varenicline tablets will be dispensed with specific instructions to take at the recommended doses for smoking cessation Participants will receive brief smoking cessation counseling and referral to a quitline"
167258|NCT01685996|O2|Outcome|Placebo|"Participants will receive placebo capsules to take once a day~placebo"
167259|NCT01685996|O1|Outcome|Zonisamide|"participants will receive zonisamide capsules (up to 300 mg) to take once a day.~zonisamide: In addition to zonisamide vs placebo treatment, varenicline tablets will be dispensed with specific instructions to take at the recommended doses for smoking cessation Participants will receive brief smoking cessation counseling and referral to a quitline"
167260|NCT01685996|O2|Outcome|Placebo|"Participants will receive placebo capsules to take once a day~placebo"
167261|NCT01685996|O1|Outcome|Zonisamide|"participants will receive zonisamide capsules (up to 300 mg) to take once a day.~zonisamide: In addition to zonisamide vs placebo treatment, varenicline tablets will be dispensed with specific instructions to take at the recommended doses for smoking cessation Participants will receive brief smoking cessation counseling and referral to a quitline"
167263|NCT01685996|E1|Reported Event|Zonisamide|"participants will receive zonisamide capsules (up to 300 mg) to take once a day.~zonisamide: In addition to zonisamide vs placebo treatment, varenicline tablets will be dispensed with specific instructions to take at the recommended doses for smoking cessation Participants will receive brief smoking cessation counseling and referral to a quitline"
167264|NCT01685983|B1|Baseline|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
167265|NCT01685983|P1|Participant Flow|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
167266|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
167267|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
167268|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
167269|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
167270|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
167271|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
167272|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
167273|NCT01685983|E1|Reported Event|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
167274|NCT01685840|B3|Baseline|Total|Total of all reporting groups
167275|NCT01685840|B2|Baseline|Biomarker-Guided Care|"Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.~Biomarker-guided care NT-proBNP: Device: NT-proBNP"
167276|NCT01685840|B1|Baseline|Usual Care|"Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.~Usual Care: Usual Care"
167277|NCT01685840|P2|Participant Flow|Biomarker-Guided Care|"Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.~Biomarker-guided care NT-proBNP: Device: NT-proBNP"
167278|NCT01685840|P1|Participant Flow|Usual Care|"Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.~Usual Care: Usual Care"
167279|NCT01685840|O2|Outcome|Usual Care|"Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.~Usual Care: Usual Care"
167280|NCT01685840|O1|Outcome|Biomarker-Guided Care|"Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.~Biomarker-guided care NT-proBNP: Device: NT-proBNP"
167281|NCT01685840|O2|Outcome|Usual Care|"Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.~Usual Care: Usual Care"
167282|NCT01685840|O1|Outcome|Biomarker-Guided Care|"Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.~Biomarker-guided care NT-proBNP: Device: NT-proBNP"
167283|NCT01685840|O2|Outcome|Biomarker-Guided Care|"Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.~Biomarker-guided care NT-proBNP: Device: NT-proBNP"
167327|NCT01685801|O2|Outcome|Crossover Double-blind Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks either during the double blind period 1 or 2 of cycle 1 and cycle 2.
167457|NCT01685242|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167284|NCT01685840|O1|Outcome|Usual Care|"Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.~Usual Care: Usual Care"
167285|NCT01685840|O2|Outcome|Biomarker-Guided Care|"Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.~Biomarker-guided care NT-proBNP: Device: NT-proBNP"
167286|NCT01685840|O1|Outcome|Usual Care|"Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.~Usual Care: Usual Care"
167287|NCT01685840|O2|Outcome|Biomarker-Guided Care|"Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.~Biomarker-guided care NT-proBNP: Device: NT-proBNP"
167288|NCT01685840|O1|Outcome|Usual Care|"Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.~Usual Care: Usual Care"
167289|NCT01685840|O2|Outcome|Biomarker-Guided Care|"Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.~Biomarker-guided care NT-proBNP: Device: NT-proBNP"
167290|NCT01685840|O1|Outcome|Usual Care|"Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.~Usual Care: Usual Care"
167291|NCT01685840|O2|Outcome|Biomarker-Guided Care|"Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.~Biomarker-guided care NT-proBNP: Device: NT-proBNP"
167292|NCT01685840|O1|Outcome|Usual Care|"Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.~Usual Care: Usual Care"
167293|NCT01685840|O2|Outcome|Biomarker-Guided Care|"Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.~Biomarker-guided care NT-proBNP: Device: NT-proBNP"
167294|NCT01685840|O1|Outcome|Usual Care|"Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.~Usual Care: Usual Care"
167295|NCT01685840|O2|Outcome|Biomarker-Guided Care|"Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.~Biomarker-guided care NT-proBNP: Device: NT-proBNP"
167296|NCT01685840|O1|Outcome|Usual Care|"Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.~Usual Care: Usual Care"
167297|NCT01685840|O2|Outcome|Biomarker-Guided Care|"Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.~Biomarker-guided care NT-proBNP: Device: NT-proBNP"
167298|NCT01685840|O1|Outcome|Usual Care|"Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.~Usual Care: Usual Care"
167299|NCT01685840|O2|Outcome|Biomarker-Guided Care|"Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.~Biomarker-guided care NT-proBNP: Device: NT-proBNP"
167300|NCT01685840|O1|Outcome|Usual Care|"Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.~Usual Care: Usual Care"
167301|NCT01685840|O2|Outcome|Biomarker-Guided Care|"Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.~Biomarker-guided care NT-proBNP: Device: NT-proBNP"
167302|NCT01685840|O1|Outcome|Usual Care|"Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.~Usual Care: Usual Care"
167303|NCT01685840|O2|Outcome|Biomarker-Guided Care|"Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.~Biomarker-guided care NT-proBNP: Device: NT-proBNP"
167304|NCT01685840|O1|Outcome|Usual Care|"Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.~Usual Care: Usual Care"
167305|NCT01685840|O2|Outcome|Biomarker-Guided Care|"Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.~Biomarker-guided care NT-proBNP: Device: NT-proBNP"
167306|NCT01685840|O1|Outcome|Usual Care|"Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.~Usual Care: Usual Care"
167307|NCT01685840|O2|Outcome|Biomarker-Guided Care|"Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.~Biomarker-guided care NT-proBNP: Device: NT-proBNP"
167308|NCT01685840|O1|Outcome|Usual Care|"Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.~Usual Care: Usual Care"
167309|NCT01685840|O2|Outcome|Biomarker-Guided Care|"Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.~Biomarker-guided care NT-proBNP: Device: NT-proBNP"
167310|NCT01685840|O1|Outcome|Usual Care|"Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.~Usual Care: Usual Care"
167311|NCT01685840|O2|Outcome|Biomarker-Guided Care|"Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.~Biomarker-guided care NT-proBNP: Device: NT-proBNP"
167312|NCT01685840|O1|Outcome|Usual Care|"Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.~Usual Care: Usual Care"
167313|NCT01685840|O2|Outcome|Biomarker-Guided Care|"Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.~Biomarker-guided care NT-proBNP: Device: NT-proBNP"
167314|NCT01685840|O1|Outcome|Usual Care|"Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.~Usual Care: Usual Care"
167315|NCT01685840|E2|Reported Event|Biomarker-Guided Care|"Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.~Biomarker-guided care NT-proBNP: Device: NT-proBNP"
167316|NCT01685840|E1|Reported Event|Usual Care|"Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.~Usual Care: Usual Care"
167317|NCT01685801|B5|Baseline|Total|Total of all reporting groups
167318|NCT01685801|B4|Baseline|PIPI|Detailed reporting group description is provided in Participant Flow module.
167319|NCT01685801|B3|Baseline|PIIP|Detailed reporting group description is provided in Participant Flow module.
167320|NCT01685801|B2|Baseline|IPPI|Detailed reporting group description is provided in Participant Flow module.
167321|NCT01685801|B1|Baseline|IPIP|Detailed reporting group description is provided in Participant Flow module.
167322|NCT01685801|P4|Participant Flow|Placebo, Ivacaftor, Placebo, Ivacaftor (PIPI)|During the Crossover Period, study drug was administered in 2-week alternating cycles with a minimum of 4-week washout period between Cycle 1 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and Cycle 2 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and between Cycle 2 and the Open-label Period (Day 1 to 57). During the Open-label Period, all participants received ivacaftor.
167323|NCT01685801|P3|Participant Flow|Placebo, Ivacaftor, Ivacaftor, Placebo (PIIP)|During the Crossover Period, study drug was administered in 2-week alternating cycles with a minimum of 4-week washout period between Cycle 1 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and Cycle 2 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and between Cycle 2 and the Open-label Period (Day 1 to 57). During the Open-label Period, all participants received ivacaftor.
167324|NCT01685801|P2|Participant Flow|Ivacaftor, Placebo, Placebo, Ivacaftor (IPPI)|During the Crossover Period, study drug was administered in 2-week alternating cycles with a minimum of 4-week washout period between Cycle 1 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and Cycle 2 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and between Cycle 2 and the Open-label Period (Day 1 to 57). During the Open-label Period, all participants received ivacaftor.
167325|NCT01685801|P1|Participant Flow|Ivacaftor, Placebo, Ivacaftor, Placebo (IPIP)|During the Crossover Period, study drug was administered in 2-week alternating cycles with a minimum of 4-week washout period between Cycle 1 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and Cycle 2 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and between Cycle 2 and the Open-label Period (Day 1 to 57). During the Open-label Period, all participants received ivacaftor.
168658|NCT01681576|O2|Outcome|Valsartan - ALL|Valsartan 320mg QD
167328|NCT01685801|O1|Outcome|Crossover Double-blind Period: Placebo|Placebo matched to ivacaftor tablet orally every 12 hours for 2 weeks either during the double blind period 1 or 2 of cycle 1 and cycle 2.
167329|NCT01685801|O1|Outcome|Open-label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 8 weeks during the open-label period after washout period 2.
167330|NCT01685801|O1|Outcome|Open-label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 8 weeks during the open-label period after washout period 2.
167331|NCT01685801|O1|Outcome|Open-label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours in open-label period (8 weeks) after washout period 2.
167332|NCT01685801|O1|Outcome|Open-Label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 8 weeks during the open-label period after washout period 2.
167333|NCT01685801|O4|Outcome|Cycle 2: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of cycle 2.
167334|NCT01685801|O3|Outcome|Cycle 2: Placebo|Placebo-matched-to-ivacaftor tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 2.
167335|NCT01685801|O2|Outcome|Cycle 1: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of cycle 1.
167336|NCT01685801|O1|Outcome|Cycle 1: Placebo|Placebo-matched-to-ivacaftor tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 1.
167337|NCT01685801|O4|Outcome|Cycle 2: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 2.
167338|NCT01685801|O3|Outcome|Cycle 2: Placebo|Placebo-matched-to-ivacaftor tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 2.
167339|NCT01685801|O2|Outcome|Cycle 1: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 1.
167340|NCT01685801|O1|Outcome|Cycle 1: Placebo|Placebo-matched-to-ivacaftor tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 1.
167341|NCT01685801|E3|Reported Event|Open-label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 8 weeks during the open-label period after washout period 2.
167342|NCT01685801|E2|Reported Event|Crossover Double-blind Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks either during the double blind period 1 or 2 of cycle 1 and cycle 2.
167343|NCT01685801|E1|Reported Event|Crossover Double-blind Period: Placebo|Placebo matched to ivacaftor tablet orally every 12 hours for 2 weeks either during the double blind period 1 or 2 of cycle 1 and cycle 2.
167344|NCT01685684|B3|Baseline|Total|Total of all reporting groups
167345|NCT01685684|B2|Baseline|Placebo (Double-blind Maintenance Phase)|
167346|NCT01685684|B1|Baseline|Oxycodone DETERx (Double-blind Maintenance Phase)|
167347|NCT01685684|P3|Participant Flow|Placebo (Double-blind Maintenance Phase)|Placebo: Placebo, divided into 2 doses, q12h
167348|NCT01685684|P2|Participant Flow|Oxycodone DETERx (Double-blind Maintenance Phase)|Oxycodone DETERx: 40-160 mg total daily dose of oxycodone DETERx, divided into 2 doses, q12h
167349|NCT01685684|P1|Participant Flow|Oxycodone DETERx (Titration Phase)|Achieve a stable Oxycodone DETERx dose of 40-160 mg total daily dose.
167350|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
167351|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
167352|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
167353|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
167354|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
167355|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
167356|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
167357|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
167358|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
167359|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
167360|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
167361|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
167362|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
167363|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
167364|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
167365|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
167366|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
167367|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
167368|NCT01685684|E4|Reported Event|Placebo (Double-blind Maintenance Phase)|
167369|NCT01685684|E3|Reported Event|Oxycodone DETERx (Double-blind Maintenance Phase)|
167370|NCT01685684|E2|Reported Event|Oxycodone DETERx (Titration Phase)|
167371|NCT01685684|E1|Reported Event|Screening|Serious Adverse Event (SAE) collection started during screening.
167372|NCT01685606|B1|Baseline|Cellular Immunotherapy|"A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.~cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused."
167373|NCT01685606|P1|Participant Flow|Cellular Immunotherapy|"A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.~cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused."
167374|NCT01685606|O1|Outcome|Cellular Immunotherapy|"A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.~cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused."
167375|NCT01685606|O1|Outcome|Cellular Immunotherapy|"A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.~cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused."
168659|NCT01681576|O1|Outcome|LCZ696 - ALL|LCZ696 400mg
167376|NCT01685606|E1|Reported Event|Cellular Immunotherapy|"A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.~cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused."
167377|NCT01685567|B1|Baseline|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
167378|NCT01685567|P1|Participant Flow|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
167379|NCT01685567|O1|Outcome|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
167380|NCT01685567|O1|Outcome|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
167381|NCT01685567|O1|Outcome|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
167382|NCT01685567|O1|Outcome|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
167383|NCT01685567|O1|Outcome|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
167384|NCT01685567|E1|Reported Event|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
167385|NCT01685437|B1|Baseline|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
167386|NCT01685437|P1|Participant Flow|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
167387|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
167388|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
167389|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
167390|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
167391|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
167392|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
167393|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
167394|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
167395|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
167396|NCT01685437|E1|Reported Event|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
167397|NCT01685372|B3|Baseline|Total|Total of all reporting groups
167398|NCT01685372|B2|Baseline|Fluzone Standard Dose|"Fluzone 0.5mL IM given once~Fluzone: A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm"
167399|NCT01685372|B1|Baseline|Fluzone High Dose|"Fluzone High Dose 0.5 mL intramuscularly (IM) given once~Fluzone High Dose: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm"
167400|NCT01685372|P2|Participant Flow|Fluzone Standard Dose|A single-dose of standard-dose influenza vaccine was administered to subjects randomized to this arm at T1
167401|NCT01685372|P1|Participant Flow|Fluzone High Dose|A single-dose of high-dose influenza vaccine was administered to subjects randomized to this arm at T1
167402|NCT01685372|O2|Outcome|Fluzone Standard Dose|Fluzone: A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
167403|NCT01685372|O1|Outcome|Fluzone High Dose|Fluzone High Dose: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
167404|NCT01685372|O2|Outcome|Fluzone Standard Dose|Fluzone: A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
167405|NCT01685372|O1|Outcome|Fluzone High Dose|Fluzone High Dose: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
167406|NCT01685372|O2|Outcome|Fluzone Standard Dose|Fluzone: A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
167407|NCT01685372|O1|Outcome|Fluzone High Dose|Fluzone High Dose: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
167408|NCT01685372|O2|Outcome|Fluzone Standard Dose|Fluzone: A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
167409|NCT01685372|O1|Outcome|Fluzone High Dose|Fluzone High Dose: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
167410|NCT01685372|O2|Outcome|Fluzone Standard Dose|Fluzone: A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
167411|NCT01685372|O1|Outcome|Fluzone High Dose|Fluzone High Dose: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
168660|NCT01681576|O2|Outcome|Valsartan -ALL|Valsartan 320mg QD
167413|NCT01685372|O1|Outcome|Fluzone High Dose|Fluzone High Dose: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
167414|NCT01685372|O2|Outcome|Fluzone Standard Dose|Fluzone: A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
167415|NCT01685372|O1|Outcome|Fluzone High Dose|Fluzone High Dose: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
167416|NCT01685372|O2|Outcome|Fluzone Standard Dose|Fluzone: A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
167417|NCT01685372|O1|Outcome|Fluzone High Dose|Fluzone High Dose: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
167418|NCT01685372|E2|Reported Event|Fluzone Standard Dose|Fluzone: A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
167419|NCT01685372|E1|Reported Event|Fluzone High Dose|Fluzone High Dose: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
167420|NCT01685320|B3|Baseline|Total|Total of all reporting groups
167421|NCT01685320|B2|Baseline|Indirect Laryngoscope|Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
167422|NCT01685320|B1|Baseline|Direct Laryngoscope|Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
167423|NCT01685320|P2|Participant Flow|Indirect Laryngoscope|Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
167424|NCT01685320|P1|Participant Flow|Direct Laryngoscope|Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
167425|NCT01685320|O2|Outcome|Indirect Laryngoscope|Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
167426|NCT01685320|O1|Outcome|Direct Laryngoscope|Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
167427|NCT01685320|O2|Outcome|Indirect Laryngoscope|Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
167428|NCT01685320|O1|Outcome|Direct Laryngoscope|Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
167429|NCT01685320|E2|Reported Event|Indirect Laryngoscope|Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
167430|NCT01685320|E1|Reported Event|Direct Laryngoscope|Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
167431|NCT01685242|B3|Baseline|Total|Total of all reporting groups
167432|NCT01685242|B2|Baseline|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167433|NCT01685242|B1|Baseline|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167434|NCT01685242|P2|Participant Flow|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167435|NCT01685242|P1|Participant Flow|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167436|NCT01685242|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167437|NCT01685242|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167438|NCT01685242|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167439|NCT01685242|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167440|NCT01685242|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167441|NCT01685242|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167442|NCT01685242|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167443|NCT01685242|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167444|NCT01685242|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167445|NCT01685242|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167446|NCT01685242|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167447|NCT01685242|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167448|NCT01685242|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167449|NCT01685242|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167450|NCT01685242|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167451|NCT01685242|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167452|NCT01685242|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167453|NCT01685242|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167454|NCT01685242|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167455|NCT01685242|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167456|NCT01685242|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167458|NCT01685242|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167459|NCT01685242|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167460|NCT01685242|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167461|NCT01685242|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167462|NCT01685242|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167463|NCT01685242|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167464|NCT01685242|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167465|NCT01685242|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167466|NCT01685242|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167467|NCT01685242|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167468|NCT01685242|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167469|NCT01685242|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167470|NCT01685242|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167471|NCT01685242|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167472|NCT01685242|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167473|NCT01685242|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167474|NCT01685242|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167475|NCT01685242|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167476|NCT01685242|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167477|NCT01685242|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167478|NCT01685242|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167479|NCT01685242|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167480|NCT01685242|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167481|NCT01685242|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167482|NCT01685242|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167483|NCT01685242|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167484|NCT01685242|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167485|NCT01685242|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167486|NCT01685242|E2|Reported Event|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
167487|NCT01685242|E1|Reported Event|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
167488|NCT01685216|B1|Baseline|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
167489|NCT01685216|P1|Participant Flow|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
167490|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
167491|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
167492|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
167493|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
167494|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
167495|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
167496|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
167497|NCT01685216|E1|Reported Event|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
167498|NCT01685203|B8|Baseline|Total|Total of all reporting groups
167499|NCT01685203|B7|Baseline|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
167500|NCT01685203|B6|Baseline|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
167501|NCT01685203|B5|Baseline|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
167502|NCT01685203|B4|Baseline|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
167503|NCT01685203|B3|Baseline|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
167504|NCT01685203|B2|Baseline|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
167505|NCT01685203|B1|Baseline|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
167506|NCT01685203|P7|Participant Flow|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
167507|NCT01685203|P6|Participant Flow|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
167508|NCT01685203|P5|Participant Flow|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
167509|NCT01685203|P4|Participant Flow|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
167510|NCT01685203|P3|Participant Flow|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
167511|NCT01685203|P2|Participant Flow|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
167512|NCT01685203|P1|Participant Flow|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
167513|NCT01685203|O7|Outcome|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
167514|NCT01685203|O6|Outcome|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
167515|NCT01685203|O5|Outcome|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
167516|NCT01685203|O4|Outcome|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
167517|NCT01685203|O3|Outcome|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
167518|NCT01685203|O2|Outcome|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
167519|NCT01685203|O1|Outcome|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
167520|NCT01685203|O7|Outcome|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
167521|NCT01685203|O6|Outcome|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
167522|NCT01685203|O5|Outcome|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
167523|NCT01685203|O4|Outcome|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
167524|NCT01685203|O3|Outcome|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
167525|NCT01685203|O2|Outcome|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
167526|NCT01685203|O1|Outcome|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
167527|NCT01685203|O7|Outcome|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
167528|NCT01685203|O6|Outcome|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
167529|NCT01685203|O5|Outcome|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
167530|NCT01685203|O4|Outcome|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
167531|NCT01685203|O3|Outcome|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
167532|NCT01685203|O2|Outcome|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
167533|NCT01685203|O1|Outcome|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
167534|NCT01685203|O7|Outcome|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
167535|NCT01685203|O6|Outcome|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
167536|NCT01685203|O5|Outcome|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
167537|NCT01685203|O4|Outcome|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
167538|NCT01685203|O3|Outcome|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
167539|NCT01685203|O2|Outcome|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
167540|NCT01685203|O1|Outcome|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
167541|NCT01685203|O7|Outcome|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
167542|NCT01685203|O6|Outcome|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
167543|NCT01685203|O5|Outcome|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
167544|NCT01685203|O4|Outcome|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
167545|NCT01685203|O3|Outcome|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
167546|NCT01685203|O2|Outcome|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
167547|NCT01685203|O1|Outcome|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
167548|NCT01685203|E7|Reported Event|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/ RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
167549|NCT01685203|E6|Reported Event|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
167550|NCT01685203|E5|Reported Event|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/ RBV (pegIFN/RBV) treatment-experienced participants
167551|NCT01685203|E4|Reported Event|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
167552|NCT01685203|E3|Reported Event|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
167553|NCT01685203|E2|Reported Event|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
167554|NCT01685203|E1|Reported Event|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
167555|NCT01685060|B1|Baseline|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
167556|NCT01685060|P1|Participant Flow|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
167557|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
167558|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
167559|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
167560|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
167561|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
167562|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
167563|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
167564|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
167565|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
167566|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
167567|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
167568|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
167569|NCT01685060|E1|Reported Event|LDK378 750 mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
167570|NCT01685021|B1|Baseline|MOR00208 (Formerly Xmab5574)|"intravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody~MOR00208 (formerly Xmab5574)"
167571|NCT01685021|P1|Participant Flow|MOR00208 (Formerly Xmab5574)|"intravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody~MOR00208 (formerly Xmab5574)~Total Patients Screened: 30 Total patients Enrolled (at least one infusion with study treatment): 22"
167638|NCT01684826|E1|Reported Event|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
167572|NCT01685021|O1|Outcome|MOR00208 (Formerly Xmab5574)|"intravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody~MOR00208 (formerly Xmab5574)~Total Patients Screened: 30 Total patients Enrolled (at least one infusion with study treatment): 22"
167573|NCT01685021|O1|Outcome|MOR00208 (Formerly Xmab5574)|"intravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody~MOR00208 (formerly Xmab5574)~Total Patients Screened: 30 Total patients Enrolled (at least one infusion with study treatment): 22"
167574|NCT01685021|O1|Outcome|MOR00208 (Formerly Xmab5574)|"intravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody~MOR00208 (formerly Xmab5574)~Total Patients Screened: 30 Total patients Enrolled (at least one infusion with study treatment): 22"
167575|NCT01685021|O1|Outcome|MOR00208 (Formerly Xmab5574)|"intravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody~MOR00208 (formerly Xmab5574)~Total Patients Screened: 30 Total patients Enrolled (at least one infusion with study treatment): 22"
167576|NCT01685021|O1|Outcome|MOR00208 (Formerly Xmab5574)|"intravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody~MOR00208 (formerly Xmab5574)~Total Patients Screened: 30 Total patients Enrolled (at least one infusion with study treatment): 22"
167577|NCT01685021|O1|Outcome|MOR00208 (Formerly Xmab5574)|"intravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody~MOR00208 (formerly Xmab5574)~Total Patients Screened: 30 Total patients Enrolled (at least one infusion with study treatment): 22"
167578|NCT01685021|E1|Reported Event|MOR00208 (Formerly Xmab5574)|"intravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody~MOR00208 (formerly Xmab5574)~Total Patients Screened: 30 Total patients Enrolled (at least one infusion with study treatment): 22"
167579|NCT01684930|B3|Baseline|Total|Total of all reporting groups
167580|NCT01684930|B2|Baseline|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
167581|NCT01684930|B1|Baseline|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
167582|NCT01684930|P2|Participant Flow|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
167583|NCT01684930|P1|Participant Flow|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
167584|NCT01684930|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
167585|NCT01684930|O1|Outcome|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
167586|NCT01684930|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
167587|NCT01684930|O1|Outcome|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
167588|NCT01684930|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
167589|NCT01684930|O1|Outcome|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
167590|NCT01684930|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
167591|NCT01684930|O1|Outcome|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
167592|NCT01684930|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
167593|NCT01684930|O1|Outcome|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
167639|NCT01684748|B3|Baseline|Total|Total of all reporting groups
168661|NCT01681576|O1|Outcome|LCZ696 - ALL|LCZ696 400mg QD
167594|NCT01684930|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
167595|NCT01684930|O1|Outcome|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
167596|NCT01684930|E2|Reported Event|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
167597|NCT01684930|E1|Reported Event|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
167598|NCT01684878|B5|Baseline|Total|Total of all reporting groups
167599|NCT01684878|B4|Baseline|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
167600|NCT01684878|B3|Baseline|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
167601|NCT01684878|B2|Baseline|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
167602|NCT01684878|B1|Baseline|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
167603|NCT01684878|P4|Participant Flow|Part 2: Placebo+Chemotherapy|Participants received pertuzumab-matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
167604|NCT01684878|P3|Participant Flow|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
167605|NCT01684878|P2|Participant Flow|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.
167606|NCT01684878|P1|Participant Flow|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.
167607|NCT01684878|O2|Outcome|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
167608|NCT01684878|O1|Outcome|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
167609|NCT01684878|O2|Outcome|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
168113|NCT01683409|B3|Baseline|Baricitinib 0.75 mg/0.5 mg BID|Baricitinib 0.75 mg or 0.5 mg administered PO BID.
167610|NCT01684878|O1|Outcome|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
167611|NCT01684878|O2|Outcome|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
167612|NCT01684878|O1|Outcome|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
167613|NCT01684878|O2|Outcome|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
167614|NCT01684878|O1|Outcome|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
167615|NCT01684878|O2|Outcome|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
167616|NCT01684878|O1|Outcome|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
167617|NCT01684878|O2|Outcome|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
167618|NCT01684878|O1|Outcome|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
167619|NCT01684878|O2|Outcome|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
167620|NCT01684878|O1|Outcome|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
167621|NCT01684878|O2|Outcome|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
167622|NCT01684878|O1|Outcome|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
167623|NCT01684878|O2|Outcome|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
167624|NCT01684878|O1|Outcome|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
167625|NCT01684878|E4|Reported Event|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
167626|NCT01684878|E3|Reported Event|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
167627|NCT01684878|E2|Reported Event|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.
167628|NCT01684878|E1|Reported Event|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.
167629|NCT01684839|B1|Baseline|New Surgical Treatment|Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
167630|NCT01684839|P1|Participant Flow|New Surgical Treatment|Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
167631|NCT01684839|O1|Outcome|New Surgical Treatment|Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
167632|NCT01684839|E1|Reported Event|New Surgical Treatment|Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
167633|NCT01684826|B1|Baseline|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
167634|NCT01684826|P1|Participant Flow|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
167635|NCT01684826|O1|Outcome|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
167636|NCT01684826|O1|Outcome|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
167637|NCT01684826|O1|Outcome|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
167640|NCT01684748|B2|Baseline|No Drug First, Then Olmesartan Medoxomil|During the First Intervention (8 weeks), no drug will be administered to the subjects. Subjects will then proceed to the Washout period (2 weeks). During the Second Intervention (8 weeks), subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks. Subjects then receive daily doses of 40 mg olmesartan for the remainder of the study period (6 weeks). The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks. In addition, subjects will continue taking the drug during the 2-week follow-up testing period.
167641|NCT01684748|B1|Baseline|Olmesartan Medoxomil First, Then No Drug|"During the First Intervention (8 weeks), subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period (6 weeks). The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks. In addition, subjects will continue taking the drug during the 2-week follow-up testing period. Subjects will then proceed to the Washout period (2 weeks). During the Second Intervention (8 weeks), no drug will be administered to the subjects.~Olmesartan medoxomil"
167642|NCT01684748|P2|Participant Flow|No Drug First, Then Olmesartan Medoxomil|During the First Intervention (8 weeks), no drug will be administered to the subjects. Subjects will then proceed to the Washout period (2 weeks). During the Second Intervention (8 weeks), subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks. Subjects then receive daily doses of 40 mg olmesartan for the remainder of the study period (6 weeks). The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks. In addition, subjects will continue taking the drug during the 2-week follow-up testing period.
167643|NCT01684748|P1|Participant Flow|Olmesartan Medoxomil First, Then No Drug|"During the First Intervention (8 weeks), subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period (6 weeks). The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks. In addition, subjects will continue taking the drug during the 2-week follow-up testing period. Subjects will then proceed to the Washout period (2 weeks). During the Second Intervention (8 weeks), no drug will be administered to the subjects.~Olmesartan medoxomil"
167644|NCT01684748|O1|Outcome|Olmesartan Medoxomil|"Subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks during the 8-week intervention. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period. The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks, subjects will continue taking the drug during the 2-week follow-up period.~Olmesartan medoxomil"
167645|NCT01684748|O2|Outcome|No Drug Intervention|The no-drug intervention (i.e., no placebo is provided) is an 8-week no intervention comparison.
167646|NCT01684748|O1|Outcome|Olmesartan Medoxomil|"Subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks during the 8-week intervention. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period. The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks, subjects will continue taking the drug during the 2-week follow-up period.~Olmesartan medoxomil"
167647|NCT01684748|E2|Reported Event|No Drug Intervention|The no-drug intervention (i.e., no placebo is provided) is an 8-week no intervention comparison.
167648|NCT01684748|E1|Reported Event|Olmesartan Medoxomil|"Subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks during the 8-week intervention. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period. The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks, subjects will continue taking the drug during the 2-week follow-up period.~Olmesartan medoxomil"
167649|NCT01684592|B3|Baseline|Total|Total of all reporting groups
167650|NCT01684592|B2|Baseline|Standard Care Plus PPCC|"Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum~Phone-based postpartum continuing care: PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby’s birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week."
167651|NCT01684592|B1|Baseline|Standard Care|"Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)~Standard care: All women will receive the standard of care approach (5 A’s and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A’s brief intervention was modified by ACOG for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up."
167652|NCT01684592|P2|Participant Flow|Standard Care Plus PPCC|"Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum~Phone-based postpartum continuing care: PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby’s birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week."
167653|NCT01684592|P1|Participant Flow|Standard Care|"Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)~Standard care: All women will receive the standard of care approach (5 A’s and referral to a 24/7 quit line postpartum) from Maryland Women's Clinic (MWC) during pregnancy. The 5 A’s brief intervention was modified by the American College of Obstetricians and Gynecologists (ACOG) for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up."
183855|NCT01627002|O4|Outcome|Part B PA401 3.0 mg|
167654|NCT01684592|O2|Outcome|Standard Care Plus PPCC|"Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum~Phone-based postpartum continuing care: PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby’s birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week."
167655|NCT01684592|O1|Outcome|Standard Care|"Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)~Standard care: All women will receive the standard of care approach (5 A’s and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A’s brief intervention was modified by ACOG for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up."
167656|NCT01684592|O2|Outcome|Standard Care Plus PPCC|"Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum~Phone-based postpartum continuing care: PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby’s birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week."
167657|NCT01684592|O1|Outcome|Standard Care|"Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)~Standard care: All women will receive the standard of care approach (5 A’s and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A’s brief intervention was modified by ACOG for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up."
167658|NCT01684592|O2|Outcome|Standard Care Plus PPCC|"Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum~Phone-based postpartum continuing care: PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby’s birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week."
167659|NCT01684592|O1|Outcome|Standard Care|"Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)~Standard care: All women will receive the standard of care approach (5 A’s and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A’s brief intervention was modified by ACOG for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up."
167660|NCT01684592|O2|Outcome|Standard Care Plus PPCC|"Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum~Phone-based postpartum continuing care: PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby’s birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week."
167661|NCT01684592|O1|Outcome|Standard Care|"Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)~Standard care: All women will receive the standard of care approach (5 A’s and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A’s brief intervention was modified by ACOG for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up."
167662|NCT01684592|O2|Outcome|Standard Care Plus PPCC|"Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum~Phone-based postpartum continuing care: PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby’s birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week."
167678|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
167663|NCT01684592|O1|Outcome|Standard Care|"Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)~Standard care: All women will receive the standard of care approach (5 A’s and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A’s brief intervention was modified by ACOG for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up."
167664|NCT01684592|O2|Outcome|Standard Care Plus PPCC|"Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum~Phone-based postpartum continuing care: PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby’s birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week."
167665|NCT01684592|O1|Outcome|Standard Care|"Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)~Standard care: All women will receive the standard of care approach (5 A’s and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A’s brief intervention was modified by ACOG for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up."
167666|NCT01684592|O2|Outcome|Standard Care Plus PPCC|"Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum~Phone-based postpartum continuing care: PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby’s birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week."
167667|NCT01684592|O1|Outcome|Standard Care|"Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)~Standard care: All women will receive the standard of care approach (5 A’s and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A’s brief intervention was modified by ACOG for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up."
167668|NCT01684592|E2|Reported Event|Standard Care Plus PPCC|"Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum~Phone-based postpartum continuing care: PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby’s birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week."
167669|NCT01684592|E1|Reported Event|Standard Care|"Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)~Standard care: All women will receive the standard of care approach (5 A’s and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A’s brief intervention was modified by ACOG for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up."
167670|NCT01684566|B3|Baseline|Total|Total of all reporting groups
167671|NCT01684566|B2|Baseline|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
167672|NCT01684566|B1|Baseline|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
167673|NCT01684566|P2|Participant Flow|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
167674|NCT01684566|P1|Participant Flow|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
167675|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
167676|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
167677|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
167679|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
167680|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
167681|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
167682|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
167683|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
167684|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
167685|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
167686|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
167687|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
167688|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
167689|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
167690|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
167691|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
167692|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
167693|NCT01684566|E2|Reported Event|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
167694|NCT01684566|E1|Reported Event|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
167695|NCT01684436|B1|Baseline|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
167696|NCT01684436|P1|Participant Flow|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
167697|NCT01684436|O1|Outcome|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
167698|NCT01684436|O1|Outcome|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
167699|NCT01684436|O1|Outcome|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
167700|NCT01684436|O1|Outcome|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
167701|NCT01684436|O1|Outcome|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
167702|NCT01684436|O1|Outcome|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
167703|NCT01684436|E1|Reported Event|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
167704|NCT01684423|B6|Baseline|Total|Total of all reporting groups
167705|NCT01684423|B5|Baseline|Comparator, Age: 6 - < 12 Years|Subjects aged from 6 - < 12 years received comparator as per standard of care.
167706|NCT01684423|B4|Baseline|Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
168662|NCT01681576|E2|Reported Event|Valsartan 320 mg QD|Valsartan 320 mg QD
167707|NCT01684423|B3|Baseline|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
167708|NCT01684423|B2|Baseline|Comparator, Age: 12 - <18 Years|Subjects aged from 12 - <18 years received comparator as per standard of care.
167709|NCT01684423|B1|Baseline|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years|Subjects aged from 12 - <18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
167710|NCT01684423|P5|Participant Flow|Comparator, Age: 6 - < 12 Years|Subjects aged from 6 - < 12 years received comparator as per standard of care.
167711|NCT01684423|P4|Participant Flow|Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
167712|NCT01684423|P3|Participant Flow|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
167713|NCT01684423|P2|Participant Flow|Comparator, Age: 12 - <18 Years|Subjects aged from 12 - <18 years received comparator as per standard of care.
167714|NCT01684423|P1|Participant Flow|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years|Subjects aged from 12 - <18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
167715|NCT01684423|O3|Outcome|Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
167716|NCT01684423|O2|Outcome|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
167717|NCT01684423|O1|Outcome|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years|Subjects aged from 12 - <18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
167718|NCT01684423|O3|Outcome|Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
167719|NCT01684423|O2|Outcome|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
167720|NCT01684423|O1|Outcome|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years|Subjects aged from 12 - <18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
167721|NCT01684423|O3|Outcome|Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
167722|NCT01684423|O2|Outcome|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
167723|NCT01684423|O1|Outcome|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years|Subjects aged from 12 - <18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
167724|NCT01684423|O3|Outcome|Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
167725|NCT01684423|O2|Outcome|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
167750|NCT01684410|B1|Baseline|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
167726|NCT01684423|O1|Outcome|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years|Subjects aged from 12 - <18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
167727|NCT01684423|O5|Outcome|Comparator, Age: 6 - < 12 Years|Subjects aged from 6 - < 12 years received comparator as per standard of care.
167728|NCT01684423|O4|Outcome|Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
167729|NCT01684423|O3|Outcome|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
167730|NCT01684423|O2|Outcome|Comparator, Age: 12 - <18 Years|Subjects aged from 12 - <18 years received comparator as per standard of care.
167731|NCT01684423|O1|Outcome|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years|Subjects aged from 12 - <18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
167732|NCT01684423|O5|Outcome|Comparator, Age: 6 - < 12 Years|Subjects aged from 6 - < 12 years received comparator as per standard of care.
167733|NCT01684423|O4|Outcome|Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
167734|NCT01684423|O3|Outcome|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
167735|NCT01684423|O2|Outcome|Comparator, Age: 12 - <18 Years|Subjects aged from 12 - <18 years received comparator as per standard of care.
167736|NCT01684423|O1|Outcome|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years|Subjects aged from 12 - <18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
167737|NCT01684423|O5|Outcome|Comparator, Age: 6 - < 12 Years|Subjects aged from 6 - < 12 years received comparator as per standard of care.
167738|NCT01684423|O4|Outcome|Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
167739|NCT01684423|O3|Outcome|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
167740|NCT01684423|O2|Outcome|Comparator, Age: 12 - <18 Years|Subjects aged from 12 - <18 years received comparator as per standard of care.
167741|NCT01684423|O1|Outcome|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years|Subjects aged from 12 - <18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
167742|NCT01684423|E5|Reported Event|Comparator, Age: 6 - < 12 Years|Subjects aged from 6 - < 12 years received comparator as per standard of care.
167743|NCT01684423|E4|Reported Event|Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
167744|NCT01684423|E3|Reported Event|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years|Subjects aged from 6 - <12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
167745|NCT01684423|E2|Reported Event|Comparator, Age: 12 - <18 Years|Subjects aged from 12 - <18 years received comparator as per standard of care.
167746|NCT01684423|E1|Reported Event|Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years|Subjects aged from 12 - <18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram [mg] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
167747|NCT01684410|B4|Baseline|Total|Total of all reporting groups
167748|NCT01684410|B3|Baseline|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).~Placebo"
167749|NCT01684410|B2|Baseline|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
167751|NCT01684410|P3|Participant Flow|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).~Placebo"
167752|NCT01684410|P2|Participant Flow|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
167753|NCT01684410|P1|Participant Flow|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
167754|NCT01684410|O3|Outcome|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).~Placebo"
167755|NCT01684410|O2|Outcome|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
167756|NCT01684410|O1|Outcome|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
167757|NCT01684410|O3|Outcome|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).~Placebo"
167758|NCT01684410|O2|Outcome|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
167759|NCT01684410|O1|Outcome|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
167760|NCT01684410|O3|Outcome|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).~Placebo"
167761|NCT01684410|O2|Outcome|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
167762|NCT01684410|O1|Outcome|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
167763|NCT01684410|E3|Reported Event|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).~Placebo"
167764|NCT01684410|E2|Reported Event|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
167765|NCT01684410|E1|Reported Event|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
167766|NCT01684215|B5|Baseline|Total|Total of all reporting groups
167767|NCT01684215|B4|Baseline|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167768|NCT01684215|B3|Baseline|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167769|NCT01684215|B2|Baseline|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167770|NCT01684215|B1|Baseline|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167771|NCT01684215|P4|Participant Flow|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167772|NCT01684215|P3|Participant Flow|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167773|NCT01684215|P2|Participant Flow|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167774|NCT01684215|P1|Participant Flow|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167775|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167776|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167777|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167778|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167779|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167780|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167781|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167782|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167783|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167784|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167785|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167786|NCT01684215|O3|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167787|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167788|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167789|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167790|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167791|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167792|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167793|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167794|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167795|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167852|NCT01684046|E2|Reported Event|RevitaLens|RevitaLens MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
167853|NCT01684046|E1|Reported Event|PureMoist|Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
167796|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167797|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167798|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167799|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167800|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167801|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167802|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167803|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167804|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167805|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167806|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167807|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167808|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167809|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167810|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167811|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167812|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167854|NCT01684033|B1|Baseline|PureMoist / Biotrue|Opti-Free® PureMoist® MPDS and Biotrue™ MPS used during Period 1 and Period 2 in randomized order in crossover assignment.
168663|NCT01681576|E1|Reported Event|LCZ696 400 mg QD|LCZ696 400 mg QD
167813|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167814|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167815|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167816|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167817|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167818|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167819|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167820|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167821|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167822|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167823|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167824|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167825|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167826|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167827|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167828|NCT01684215|O4|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167829|NCT01684215|O3|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167830|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167831|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167832|NCT01684215|O3|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167833|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167834|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167835|NCT01684215|O3|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167836|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167837|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167838|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167839|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167840|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167841|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167842|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167843|NCT01684215|E4|Reported Event|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167844|NCT01684215|E3|Reported Event|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167845|NCT01684215|E2|Reported Event|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167846|NCT01684215|E1|Reported Event|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
167847|NCT01684046|B1|Baseline|PureMoist / RevitaLens|Opti-Free® PureMoist® MPDS and RevitaLens MPDS used during Period 1 and Period 2 in randomized order in crossover assignment.
167848|NCT01684046|P2|Participant Flow|RevitaLens - PureMoist|RevitaLens MPDS, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
167849|NCT01684046|P1|Participant Flow|PureMoist - RevitaLens|Opti-Free® PureMoist® MPDS, followed by RevitaLens MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
167850|NCT01684046|O2|Outcome|RevitaLens|RevitaLens MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
167851|NCT01684046|O1|Outcome|PureMoist|Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
168108|NCT01683526|E2|Reported Event|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
167855|NCT01684033|P2|Participant Flow|Biotrue - PureMoist|Biotrue™ MPS, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
167856|NCT01684033|P1|Participant Flow|PureMoist - Biotrue|Opti-Free® PureMoist® MPDS, followed by Biotrue™ MPS. Each product used as indicated for 30 days with participant's habitual contact lenses.
167857|NCT01684033|O2|Outcome|Biotrue|Biotrue™ MPS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
167858|NCT01684033|O1|Outcome|PureMoist|Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
167859|NCT01684033|O2|Outcome|Biotrue|Biotrue™ MPS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
167860|NCT01684033|O1|Outcome|PureMoist|Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
167861|NCT01684033|E2|Reported Event|Biotrue|Biotrue™ MPS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
167862|NCT01684033|E1|Reported Event|PureMoist|Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
167863|NCT01684007|B3|Baseline|Total|Total of all reporting groups
167864|NCT01684007|B2|Baseline|Contralateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
167865|NCT01684007|B1|Baseline|Bilateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
167866|NCT01684007|P2|Participant Flow|Contralateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
167867|NCT01684007|P1|Participant Flow|Bilateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
167868|NCT01684007|O2|Outcome|Contralateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
167869|NCT01684007|O1|Outcome|Bilateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
167870|NCT01684007|O2|Outcome|Contralateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
167871|NCT01684007|O1|Outcome|Bilateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
167872|NCT01684007|E2|Reported Event|Contralateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
167873|NCT01684007|E1|Reported Event|Bilateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
167874|NCT01683864|B4|Baseline|Total|Total of all reporting groups
167875|NCT01683864|B3|Baseline|Negative Cytology Without HIPEC|gastric cancer with negative cytology
167876|NCT01683864|B2|Baseline|Positive Cytology no HIPEC|gastric cancer cytology positive without HIPEC
167877|NCT01683864|B1|Baseline|Positive Cytology With HIPEC|gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative positive cytology with HIPEC: HIPEC with mytomycin and cisplatin
167878|NCT01683864|P3|Participant Flow|Negative Cytology Without HIPEC|gastric cancer with negative cytology
167879|NCT01683864|P2|Participant Flow|Positive Cytology Without HIPEC|gastric cancer cytology positive without HIPEC
167880|NCT01683864|P1|Participant Flow|Positive Cytology With HIPEC|gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative positive cytology with HIPEC: HIPEC with mytomycin and cisplatin
167881|NCT01683864|O3|Outcome|Negative Cytology Without HIPC|gastric cancer negative cytology without HIPC
167882|NCT01683864|O2|Outcome|Positive Cytology Witout HIPEC|gastric cancer positive cytology without HIPC
167883|NCT01683864|O1|Outcome|Positive Cytology With HIPEC|gastric Cancer cytology positive with HIPEC
167884|NCT01683864|E3|Reported Event|Negative Cytology Without HIPEC|gastric cancer with negative cytology Adverse Event : NA
167885|NCT01683864|E2|Reported Event|Positive Cytology no HIPEC|gastric cancer cytology positive without HIPEC Adverse Event : NA
167886|NCT01683864|E1|Reported Event|Positive Cytology With HIPEC|gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative positive cytology with HIPEC: HIPEC with mytomycin and cisplatin Adverse Event : NA
167887|NCT01683838|B3|Baseline|Total|Total of all reporting groups
167888|NCT01683838|B2|Baseline|Placebo|Placebo : Placebo
167889|NCT01683838|B1|Baseline|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
167890|NCT01683838|P2|Participant Flow|Placebo|Placebo : Placebo
167891|NCT01683838|P1|Participant Flow|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
167892|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
167893|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
167894|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
167895|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
167896|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
167897|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
167898|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
167899|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
167900|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
167901|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
167902|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
167903|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
167904|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
167905|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
167906|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
167907|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
167908|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
167909|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
167910|NCT01683838|E2|Reported Event|Placebo|Placebo : Placebo
167911|NCT01683838|E1|Reported Event|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
167912|NCT01683812|B1|Baseline|Cranial Cup Arm|"Single arm~Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day."
167913|NCT01683812|P1|Participant Flow|Cranial Cup Arm|"Single arm~Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day."
167914|NCT01683812|O1|Outcome|Cranial Cup Arm|"Single arm~Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day."
167915|NCT01683812|O1|Outcome|Cranial Cup Arm|"Single arm~Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day."
167916|NCT01683812|E1|Reported Event|Cranial Cup Arm|"Single arm~Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day."
167917|NCT01683630|B3|Baseline|Total|Total of all reporting groups
167918|NCT01683630|B2|Baseline|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
167919|NCT01683630|B1|Baseline|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
167920|NCT01683630|P2|Participant Flow|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
167921|NCT01683630|P1|Participant Flow|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
167922|NCT01683630|O2|Outcome|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
167923|NCT01683630|O1|Outcome|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
167924|NCT01683630|O2|Outcome|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
167925|NCT01683630|O1|Outcome|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
167926|NCT01683630|O2|Outcome|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
167927|NCT01683630|O1|Outcome|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
167928|NCT01683630|E2|Reported Event|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
167929|NCT01683630|E1|Reported Event|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
167930|NCT01683604|B1|Baseline|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167931|NCT01683604|P1|Participant Flow|Rheumatoid Arthritis (RA) Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167932|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167933|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167934|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
167935|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167936|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167937|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167938|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167939|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
167940|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167941|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167942|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167943|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167944|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
167945|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167946|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167947|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167948|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167949|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
167950|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167951|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167952|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167953|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167954|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
167955|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167956|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167957|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167958|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167959|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
167960|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167961|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167962|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167963|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167964|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
167965|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167966|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167967|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167968|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167969|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
167970|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167971|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167972|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167973|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167974|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
167975|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167976|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167977|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167978|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167979|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
167980|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167981|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167982|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167983|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167984|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
167985|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167986|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167987|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167988|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167989|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
167990|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167991|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167992|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167993|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167994|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
167995|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167996|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167997|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167998|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
167999|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
168000|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168001|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168002|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168003|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168004|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
168005|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168006|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168007|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168008|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168009|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
168010|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168011|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168012|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168013|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168014|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
168015|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168016|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168017|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168018|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168019|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
168020|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168021|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168022|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168023|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168024|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
168025|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168026|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168027|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168028|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168029|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
168030|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168031|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168032|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168033|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168034|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
168035|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168036|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168037|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168038|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168039|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
168040|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168041|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168042|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168043|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168044|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
168045|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168046|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168047|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168048|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168049|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
168050|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168051|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168052|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168053|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168054|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
168055|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168056|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168057|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168058|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168059|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
168060|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168061|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168062|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168063|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168064|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
168065|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168066|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168067|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168068|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168069|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
168070|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168109|NCT01683526|E1|Reported Event|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
168110|NCT01683409|B6|Baseline|Total|Total of all reporting groups
168071|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168072|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168073|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168074|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
168075|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168076|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168077|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168078|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168079|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
168080|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168081|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168082|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168083|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168084|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
168085|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168086|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168087|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168088|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168089|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
168090|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168091|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168092|NCT01683604|E1|Reported Event|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
168093|NCT01683526|B3|Baseline|Total|Total of all reporting groups
168094|NCT01683526|B2|Baseline|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
168095|NCT01683526|B1|Baseline|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
168096|NCT01683526|P2|Participant Flow|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
168097|NCT01683526|P1|Participant Flow|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
168098|NCT01683526|O2|Outcome|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
168099|NCT01683526|O1|Outcome|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
168100|NCT01683526|O2|Outcome|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
168101|NCT01683526|O1|Outcome|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
168102|NCT01683526|O2|Outcome|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
168103|NCT01683526|O1|Outcome|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
168104|NCT01683526|O2|Outcome|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
168105|NCT01683526|O1|Outcome|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
168106|NCT01683526|O2|Outcome|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
168107|NCT01683526|O1|Outcome|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
168111|NCT01683409|B5|Baseline|Baricitinib 4 mg/2.75 mg|Baricitinib 4 mg or 2.75 administered PO QD.
168114|NCT01683409|B2|Baseline|Baricitinib 0.75/0.5 mg QD|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
168115|NCT01683409|B1|Baseline|Placebo|Placebo administered PO QD.
168116|NCT01683409|P5|Participant Flow|Baricitinib 4 mg/2.75 mg|Baricitinib 4 milligram (mg) or 2.75 mg administered PO QD.
168117|NCT01683409|P4|Participant Flow|Baricitinib 1.5 mg/1 mg|Baricitinib 1.5 mg or 1 mg administered PO QD.
168118|NCT01683409|P3|Participant Flow|Baricitinib 0.75 mg/0.5 mg BID|Baricitinib 0.75 mg or 0.5 mg administered PO twice a day (BID).
168119|NCT01683409|P2|Participant Flow|Baricitinib 0.75 mg/0.5 mg QD|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
168120|NCT01683409|P1|Participant Flow|Placebo|Placebo administered orally (PO) once a day (QD).
168121|NCT01683409|O4|Outcome|Baricitinib 4 mg/2.75 mg|Baricitinib 4 mg or 2.75 mg administered PO QD.
168122|NCT01683409|O3|Outcome|Baricitinib 1.5 mg/1 mg|Baricitinib 1.5 mg or 1 mg administered PO QD.
168123|NCT01683409|O2|Outcome|Baricitinib 0.75 mg/0.5 mg BID|Baricitinib 0.75 mg or 0.5 mg administered PO BID.
168124|NCT01683409|O1|Outcome|Baricitinib 0.75 mg/0.5 mg QD|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
168125|NCT01683409|O5|Outcome|Baricitinib 4 mg/2.75 mg|Baricitinib 4 mg or 2.75 mg administered PO QD.
168126|NCT01683409|O4|Outcome|Baricitinib 1.5 mg/1 mg|Baricitinib 1.5 mg or 1 mg administered PO QD.
168127|NCT01683409|O3|Outcome|Baricitinib 0.75 mg/0.5 mg BID|Baricitinib 0.75 mg or 0.5 mg administered PO BID.
168128|NCT01683409|O2|Outcome|Baricitinib 0.75 mg/0.5 mg QD|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
168129|NCT01683409|O1|Outcome|Placebo|Placebo administered PO QD.
168130|NCT01683409|O5|Outcome|Baricitinib 4 mg/2.75 mg|Baricitinib 4 mg or 2.75 mg administered PO QD.
168131|NCT01683409|O4|Outcome|Baricitinib 1.5 mg/1 mg|Baricitinib 1.5 mg or 1 mg administered PO QD.
168132|NCT01683409|O3|Outcome|Baricitinib 0.75 mg/0.5 mg BID|Baricitinib 0.75 mg or 0.5 mg administered PO BID.
168133|NCT01683409|O2|Outcome|Baricitinib 0.75 mg/0.5 mg QD|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
168134|NCT01683409|O1|Outcome|Placebo|Placebo administered PO QD.
168135|NCT01683409|O5|Outcome|Baricitinib 4 mg/2.75 mg|Baricitinib 4 mg or 2.75 mg administered PO QD.
168136|NCT01683409|O4|Outcome|Baricitinib 1.5 mg/1 mg|Baricitinib 1.5 mg or 1 mg administered PO QD.
168137|NCT01683409|O3|Outcome|Baricitinib 0.75 mg/0.5 mg BID|Baricitinib 0.75 mg or 0.5 mg administered PO BID.
168138|NCT01683409|O2|Outcome|Baricitinib 0.75 mg/0.5 mg QD|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
168139|NCT01683409|O1|Outcome|Placebo|Placebo administered PO QD.
168140|NCT01683409|O5|Outcome|Baricitinib 4 mg/2.75 mg|Baricitinib 4 mg or 2.75 mg administered PO QD.
168141|NCT01683409|O4|Outcome|Baricitinib 1.5 mg/1 mg|Baricitinib 1.5 mg or 1 mg administered PO QD.
168142|NCT01683409|O3|Outcome|Baricitinib 0.75 mg/0.5 mg BID|Baricitinib 0.75 mg or 0.5 mg administered PO BID.
168143|NCT01683409|O2|Outcome|Baricitinib 0.75 mg/0.5 mg QD|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
168144|NCT01683409|O1|Outcome|Placebo|Placebo administered PO QD.
168145|NCT01683409|E15|Reported Event|Baricitinib 4 mg/2.75 mg - Washout 2|Baricitinib 4 mg or 2.75 mg administered PO QD.
168146|NCT01683409|E14|Reported Event|Baricitinib 1.5 mg/1 mg - Washout 2|Baricitinib 1.5 mg or 1 mg administered PO QD.
168147|NCT01683409|E13|Reported Event|Baricitinib 0.75 mg/0.5 mg BID - Washout 2|Baricitinib 0.75 mg or 0.5 mg administered PO BID.
168148|NCT01683409|E12|Reported Event|Baricitinib 0.75 mg/0.5 mg QD - Washout 2|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
168149|NCT01683409|E11|Reported Event|Placebo Washout 2|Placebo administered PO QD.
168150|NCT01683409|E10|Reported Event|Baricitinib 4 mg/2.75 mg - Washout 1|Baricitinib 4 mg or 2.75 mg administered PO QD.
168151|NCT01683409|E9|Reported Event|Baricitinib 1.5 mg/1 mg - Washout 1|Baricitinib 1.5 mg or 1 mg administered PO QD.
168152|NCT01683409|E8|Reported Event|Baricitinib 0.75 mg/0.5 mg BID - Washout 1|Baricitinib 0.75 mg or 0.5 mg administered PO BID.
168153|NCT01683409|E7|Reported Event|Baricitinib 0.75 mg/0.5 mg QD - Washout 1|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
168154|NCT01683409|E6|Reported Event|Placebo - Washout 1|Placebo administered PO QD.
168155|NCT01683409|E5|Reported Event|Baricitinib 4 mg/2.75 mg|Baricitinib 4 mg or 2.75 mg administered PO QD.
168156|NCT01683409|E4|Reported Event|Baricitinib 1.5 mg/1 mg|Baricitinib 1.5 mg or 1 mg administered PO QD.
168157|NCT01683409|E3|Reported Event|Baricitinib 0.75 mg/0.5 mg BID|Baricitinib 0.75 mg or 0.5 mg administered PO BID.
168158|NCT01683409|E2|Reported Event|Baricitinib 0.75 mg/0.5 mg QD|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
168159|NCT01683409|E1|Reported Event|Placebo|Placebo administered PO QD.
168160|NCT01683383|B3|Baseline|Total|Total of all reporting groups
168161|NCT01683383|B2|Baseline|Device (Servo-regulated Cooling)|Infants were placed on a servo-controlled cooling blanket after a rectal or esophageal probe was inserted. The temperature was servo-controlled using the Tecotherm Neo (Inspiration Medical LTD, Leicester, UK) (Appendix 1; online only) with the target temperature set to 33.5°C.
168162|NCT01683383|B1|Baseline|Control (Standard Cooling)|Infants were cooled as per the birth hospital practice either passively (turning the radiant warmer /incubator off) and/or actively (ice or gel packs).
168163|NCT01683383|P2|Participant Flow|Device (Servo-regulated Cooling)|Infants were placed on a servo-controlled cooling blanket after a rectal or esophageal probe was inserted. The temperature was servo-controlled using the Tecotherm Neo (Inspiration Medical LTD, Leicester, UK) (Appendix 1; online only) with the target temperature set to 33.5°C.
168164|NCT01683383|P1|Participant Flow|Control (Standard Cooling)|Infants were cooled as per the birth hospital practice either passively (turning the radiant warmer /incubator off) and/or actively (ice or gel packs).
168165|NCT01683383|O2|Outcome|Device (Servo-regulated Cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
168166|NCT01683383|O1|Outcome|Control (Standard Cooling)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
168167|NCT01683383|O2|Outcome|Device (Servo-regulated Cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
168168|NCT01683383|O1|Outcome|Control (Standard Cooling)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
168169|NCT01683383|O2|Outcome|Device (Servo-regulated Cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
168170|NCT01683383|O1|Outcome|Control (Standard Cooling)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
168171|NCT01683383|O2|Outcome|Device (Servo-regulated Cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
168172|NCT01683383|O1|Outcome|Control (Standard Cooling)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
168173|NCT01683383|O2|Outcome|Device (Servo-regulated Cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
168174|NCT01683383|O1|Outcome|Control (Standard Cooling)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
168175|NCT01683383|E2|Reported Event|Device (Servo-regulated Cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
168176|NCT01683383|E1|Reported Event|Control (Standard Cooling)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
168177|NCT01683266|B3|Baseline|Total|Total of all reporting groups
168178|NCT01683266|B2|Baseline|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168179|NCT01683266|B1|Baseline|HOE901­-U300|HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168180|NCT01683266|P2|Participant Flow|Lantus|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning or evening for 12 months on top of mealtime insulin analogue.
168181|NCT01683266|P1|Participant Flow|HOE901­-U300|HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily in morning or evening for 12 months on top of mealtime insulin analogue.
168182|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168183|NCT01683266|O1|Outcome|HOE901-­U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168184|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168185|NCT01683266|O1|Outcome|HOE901-­U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168186|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168187|NCT01683266|O1|Outcome|HOE901­-U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168188|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168189|NCT01683266|O1|Outcome|HOE901­-U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168190|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168191|NCT01683266|O1|Outcome|HOE901-­U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168192|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168193|NCT01683266|O1|Outcome|HOE901-­U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168194|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168195|NCT01683266|O1|Outcome|HOE901-­U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168196|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168197|NCT01683266|O1|Outcome|HOE901­-U300|HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168198|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168199|NCT01683266|O1|Outcome|HOE901­-U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168200|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168201|NCT01683266|O1|Outcome|HOE901-­U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168202|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168203|NCT01683266|O1|Outcome|HOE901­-U300|HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168204|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168205|NCT01683266|O1|Outcome|HOE901­-U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168206|NCT01683266|E2|Reported Event|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168207|NCT01683266|E1|Reported Event|HOE901-­U300|HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
168287|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
168208|NCT01683058|B1|Baseline|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168209|NCT01683058|P1|Participant Flow|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168210|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168211|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168212|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168213|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168214|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168215|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168216|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168217|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168218|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168219|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168220|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168221|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168222|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168223|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168224|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168225|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168226|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168227|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168228|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168229|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168230|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168231|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168232|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168233|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168234|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168235|NCT01683058|E1|Reported Event|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
168236|NCT01683019|B4|Baseline|Total|Total of all reporting groups
168237|NCT01683019|B3|Baseline|Inactive Sham Treatment|"Generate sound similar to active treatment, except that no magnetic field is generated.~Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated."
168238|NCT01683019|B2|Baseline|Active Random Frequency Magnetic Stimulation|"Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
168239|NCT01683019|B1|Baseline|Active Fixed Alpha Frequency Magnetic Stimulation|"Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
168240|NCT01683019|P3|Participant Flow|Inactive Sham Treatment|"Generate sound similar to active treatment, except that no magnetic field is generated.~Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated."
168241|NCT01683019|P2|Participant Flow|Active Random Frequency Magnetic Stimulation|"Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
168242|NCT01683019|P1|Participant Flow|Active Fixed Alpha Frequency Magnetic Stimulation|"Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
168288|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
168243|NCT01683019|O3|Outcome|Inactive Sham Treatment|"Generate sound similar to active treatment, except that no magnetic field is generated.~Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated."
168244|NCT01683019|O2|Outcome|Active Random Frequency Magnetic Stimulation|"Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
168245|NCT01683019|O1|Outcome|Active Fixed Alpha Frequency Magnetic Stimulation|"Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
168246|NCT01683019|E3|Reported Event|Inactive Sham Treatment|"Generate sound similar to active treatment, except that no magnetic field is generated.~Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated."
168247|NCT01683019|E2|Reported Event|Active Random Frequency Magnetic Stimulation|"Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
168248|NCT01683019|E1|Reported Event|Active Fixed Alpha Frequency Magnetic Stimulation|"Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
168249|NCT01682954|B3|Baseline|Total|Total of all reporting groups
168250|NCT01682954|B2|Baseline|Usual Care|Usual care from primary care physician
168251|NCT01682954|B1|Baseline|Lifestyle Counseling|"Diabetes Prevention Program lifestyle intervention~Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention"
168252|NCT01682954|P2|Participant Flow|Usual Care|Usual care from primary care physician
168253|NCT01682954|P1|Participant Flow|Lifestyle Counseling|"Diabetes Prevention Program lifestyle intervention~Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention"
168254|NCT01682954|O2|Outcome|Usual Care|Usual care from primary care physician
168255|NCT01682954|O1|Outcome|Lifestyle Counseling|"Diabetes Prevention Program lifestyle intervention~Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention"
168256|NCT01682954|O2|Outcome|Usual Care|Usual care from primary care physician
168257|NCT01682954|O1|Outcome|Lifestyle Counseling|"Diabetes Prevention Program lifestyle intervention~Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention"
168258|NCT01682954|E2|Reported Event|Usual Care|Usual care from primary care physician
168259|NCT01682954|E1|Reported Event|Lifestyle Counseling|"Diabetes Prevention Program lifestyle intervention~Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention"
168260|NCT01682876|B5|Baseline|Total|Total of all reporting groups
168261|NCT01682876|B4|Baseline|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
168262|NCT01682876|B3|Baseline|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
168263|NCT01682876|B2|Baseline|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
168264|NCT01682876|B1|Baseline|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
168265|NCT01682876|P4|Participant Flow|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
168266|NCT01682876|P3|Participant Flow|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
168267|NCT01682876|P2|Participant Flow|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
168268|NCT01682876|P1|Participant Flow|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
168269|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
168270|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
168271|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
168272|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
168273|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
168274|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
168275|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
168276|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
168277|NCT01682876|O2|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
168278|NCT01682876|O1|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
168279|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
168280|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
168281|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
168282|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
168283|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
168284|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
168285|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
168286|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
168289|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
168290|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
168291|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
168292|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
168293|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
168294|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
168295|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
168296|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
168297|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
168298|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
168299|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
168300|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
168301|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
168302|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
168303|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
168304|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
168305|NCT01682876|E5|Reported Event|Total|Total Population
168306|NCT01682876|E4|Reported Event|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
168307|NCT01682876|E3|Reported Event|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
168308|NCT01682876|E2|Reported Event|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
168309|NCT01682876|E1|Reported Event|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
168310|NCT01682863|B4|Baseline|Total|Total of all reporting groups
168311|NCT01682863|B3|Baseline|QAB149 75 ug od|
168312|NCT01682863|B2|Baseline|QVA149 27.5/25 ug Bid|
168313|NCT01682863|B1|Baseline|QVA149 27.5/12.5 ug Bid|
168314|NCT01682863|P3|Participant Flow|QAB149 75 ug od|
168315|NCT01682863|P2|Participant Flow|QVA149 27.5/25 ug Bid|
168316|NCT01682863|P1|Participant Flow|QVA149 27.5/12.5 ug Bid|
168317|NCT01682863|O3|Outcome|QAB149 75 ug od|
168318|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
168319|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
168320|NCT01682863|O3|Outcome|QAB149 75 ug od|
168321|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
168322|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
168323|NCT01682863|O3|Outcome|QAB149 75 ug od|
168324|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
168325|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
168326|NCT01682863|O3|Outcome|QAB149 75 ug od|
168327|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
168328|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
168329|NCT01682863|O3|Outcome|QAB149 75 ug od|
168330|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
168331|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
168332|NCT01682863|O3|Outcome|QAB149 75 ug od|
168333|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
168334|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
168335|NCT01682863|O3|Outcome|QAB149 75 ug od|
168336|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
168337|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
168338|NCT01682863|O3|Outcome|QAB149 75 ug od|
168339|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
168340|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
168341|NCT01682863|E3|Reported Event|QAB75|QVA149 27.5/25 μg capsules
168342|NCT01682863|E2|Reported Event|QVA149 27.5/25 ug Bid|
168343|NCT01682863|E1|Reported Event|QVA149 27.5/12.5 ug Bid|
168344|NCT01682837|B1|Baseline|All Study Participants|Participants received the following study drug in random order: Potassium Magnesium Citrate powder, Potassium Citrate powder, Potassium Chloride powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
168345|NCT01682837|P1|Participant Flow|All Study Participants|Participants received the following study drug in random order: Potassium Magnesium Citrate (KMgCit) powder, Potassium Citrate (KCit) powder, Potassium Chloride (KCl) powder and Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Individual study drug assignments per randomization is provided in the comments for each study period.
168346|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
168347|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
168348|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
168349|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
168350|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
168351|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
168352|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
168353|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
168355|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
168356|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
168357|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
168358|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
168359|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
168360|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
168361|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
168362|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
168363|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
168364|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
168365|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
168366|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
168367|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
168368|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
168369|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
168370|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
168371|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
168372|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
168373|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
168374|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
168375|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
168376|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
168377|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
168378|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
168379|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
168380|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
168381|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
168382|NCT01682837|E4|Reported Event|Placebo Phase|Participants undergoing the Placebo phase of the study.
168383|NCT01682837|E3|Reported Event|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
168384|NCT01682837|E2|Reported Event|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
168385|NCT01682837|E1|Reported Event|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
168386|NCT01682759|B3|Baseline|Total|Total of all reporting groups
168387|NCT01682759|B2|Baseline|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
168388|NCT01682759|B1|Baseline|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
168389|NCT01682759|P2|Participant Flow|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
168390|NCT01682759|P1|Participant Flow|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
168391|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
168392|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
168393|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
168394|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
168395|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
168396|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
168397|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
168398|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
168399|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
168400|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
168664|NCT01681511|B3|Baseline|Total|Total of all reporting groups
168401|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
168402|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
168403|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
168404|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
168405|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
168406|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
168407|NCT01682759|E2|Reported Event|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
168408|NCT01682759|E1|Reported Event|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
168409|NCT01682720|B5|Baseline|Total|Total of all reporting groups
168410|NCT01682720|B4|Baseline|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
168411|NCT01682720|B3|Baseline|SOF 12 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
168412|NCT01682720|B2|Baseline|SOF 12 Weeks (GT2)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
168413|NCT01682720|B1|Baseline|Placebo 12 Weeks (GT2/3)|Placebo to match SOF + placebo to match RBV for 12 weeks in participants with genotype 2 or 3 HCV infection.
168414|NCT01682720|P4|Participant Flow|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
168415|NCT01682720|P3|Participant Flow|SOF 12 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
168416|NCT01682720|P2|Participant Flow|SOF 12 Weeks (GT2)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
168417|NCT01682720|P1|Participant Flow|Placebo 12 Weeks (GT2/3)|Placebo to match sofosbuvir (SOF) + placebo to match ribavirin (RBV) for 12 weeks in participants with genotype (GT)2 or 3 HCV infection.
168418|NCT01682720|O3|Outcome|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
168419|NCT01682720|O2|Outcome|SOF 12 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
168420|NCT01682720|O1|Outcome|SOF 12 Weeks (GT2)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
168421|NCT01682720|O3|Outcome|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
168422|NCT01682720|O2|Outcome|SOF 12 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
168423|NCT01682720|O1|Outcome|SOF 12 Weeks (GT2)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
168424|NCT01682720|O3|Outcome|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
168425|NCT01682720|O2|Outcome|SOF 12 Weeks (GT2/3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
168426|NCT01682720|O1|Outcome|Placebo 12 Weeks (GT2/3)|Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
168427|NCT01682720|O3|Outcome|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
168428|NCT01682720|O2|Outcome|SOF 12 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
168429|NCT01682720|O1|Outcome|SOF 12 Weeks (GT2)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
168430|NCT01682720|E3|Reported Event|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
168431|NCT01682720|E2|Reported Event|SOF 12 Weeks (GT2/3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
168432|NCT01682720|E1|Reported Event|Placebo 12 Weeks (GT2/3)|Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
168433|NCT01682681|B1|Baseline|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
168434|NCT01682681|P1|Participant Flow|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
168435|NCT01682681|O1|Outcome|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
168689|NCT01681472|P1|Participant Flow|Levoleucovorin 200 mg/m2|Levoleucovorin: i.v. bolus injection
168436|NCT01682681|O1|Outcome|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
168437|NCT01682681|O1|Outcome|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
168438|NCT01682681|O1|Outcome|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
168439|NCT01682681|O1|Outcome|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
168440|NCT01682681|E1|Reported Event|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
168441|NCT01682642|B3|Baseline|Total|Total of all reporting groups
168442|NCT01682642|B2|Baseline|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
168443|NCT01682642|B1|Baseline|Zoladex|"After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.~Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment"
168444|NCT01682642|P2|Participant Flow|Vaporization Only|After surgical vaporization of the endometriosis , patients start immediately with IVF treatment (without additional treatment).
168445|NCT01682642|P1|Participant Flow|Zoladex|After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months immediately following the start of IVF treatment.
168446|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
168447|NCT01682642|O1|Outcome|Zoladex|After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following ivf treatment.
168448|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients immediately start IVF without additional treatment.
168449|NCT01682642|O1|Outcome|Zoladex|After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following start IVF treatment.
168450|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients immediately start IVF without additional treatment.
168451|NCT01682642|O1|Outcome|Zoladex|After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following start of IVFtreatment.
168452|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
168453|NCT01682642|O1|Outcome|Zoladex|
168454|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
168455|NCT01682642|O1|Outcome|Zoladex|After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following start of IVF treatment.
168456|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
168457|NCT01682642|O1|Outcome|Zoladex|"After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.~Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment"
168458|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
168459|NCT01682642|O1|Outcome|Zoladex|"After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.~Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment"
168460|NCT01682642|E2|Reported Event|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
168461|NCT01682642|E1|Reported Event|Zoladex|"After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.~Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment"
168462|NCT01682603|B1|Baseline|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
168463|NCT01682603|P1|Participant Flow|Botulinum Toxin A|Botulinum toxin A (BoNT-A) (BOTOX 300U)
168464|NCT01682603|O2|Outcome|Pre-Non Autonomic Dysreflexia|Baseline Non autonomic dysreflexia
168465|NCT01682603|O1|Outcome|Pre-Autonomic Dysreflexia|Baseline Autonomic dysreflexia
168466|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
168467|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
168468|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
168469|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
168470|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
168471|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
168472|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
168473|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
168474|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
168475|NCT01682603|E1|Reported Event|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
168476|NCT01682538|B1|Baseline|Overall Study|All treatment arms
168477|NCT01682538|P1|Participant Flow|All Treatment Groups|"All participants received all study treatments in a randomized fashion. Subjects were allocated to one of the following treatment sequences (2 subjects to each sequence):~A B C; B C A; C A B; C B A; A C B; B A C where A=Orfadin capsules, single dose, 30 mg; B=Orfadin suspension, single dose 30 mg, fasting; C=Orfadin suspension, single dose 30 mg, fed"
168478|NCT01682538|O3|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
168479|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
168480|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
168481|NCT01682538|O3|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
168482|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension, 4 mg/mL, single dose, 30 mg (7.5 mL)
168483|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
168484|NCT01682538|O3|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
168485|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
168486|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
168487|NCT01682538|O3|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
168488|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
168489|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
168490|NCT01682538|O3|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose, 30 mg (7,5 mL)
168491|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7,5 mL)
168492|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
168493|NCT01682538|O2|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
168494|NCT01682538|O1|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
168495|NCT01682538|O2|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
168496|NCT01682538|O1|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
168497|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7,5 mL)
168498|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
168499|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7,5 mL)
168500|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
168501|NCT01682538|E3|Reported Event|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
168502|NCT01682538|E2|Reported Event|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
168503|NCT01682538|E1|Reported Event|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
168504|NCT01682512|B4|Baseline|Total|Total of all reporting groups
168505|NCT01682512|B3|Baseline|MabThera®|Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168506|NCT01682512|B2|Baseline|Rituxan®|Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168507|NCT01682512|B1|Baseline|BI 695500|Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168508|NCT01682512|P3|Participant Flow|MabThera®|Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168509|NCT01682512|P2|Participant Flow|Rituxan®|Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168510|NCT01682512|P1|Participant Flow|BI 695500|Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168511|NCT01682512|O3|Outcome|MabThera®|Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168512|NCT01682512|O2|Outcome|Rituxan®|Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168513|NCT01682512|O1|Outcome|BI 695500|Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168514|NCT01682512|O3|Outcome|MabThera®|Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168515|NCT01682512|O2|Outcome|Rituxan®|Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168516|NCT01682512|O1|Outcome|BI 695500|Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168517|NCT01682512|O3|Outcome|MabThera®|Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168518|NCT01682512|O2|Outcome|Rituxan®|Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168519|NCT01682512|O1|Outcome|BI 695500|Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168520|NCT01682512|O3|Outcome|MabThera®|Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168690|NCT01681472|O4|Outcome|6R-MTHF 60 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
168521|NCT01682512|O2|Outcome|Rituxan®|Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168522|NCT01682512|O1|Outcome|BI 695500|Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168523|NCT01682512|O3|Outcome|MabThera®|Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168524|NCT01682512|O2|Outcome|Rituxan®|Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168525|NCT01682512|O1|Outcome|BI 695500|Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168526|NCT01682512|O3|Outcome|MabThera®|Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168527|NCT01682512|O2|Outcome|Rituxan®|Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168528|NCT01682512|O1|Outcome|BI 695500|Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168529|NCT01682512|O2|Outcome|Rituxan®|Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168530|NCT01682512|O1|Outcome|BI 695500|Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168531|NCT01682512|E3|Reported Event|MabThera®|Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168532|NCT01682512|E2|Reported Event|Rituxan®|Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168533|NCT01682512|E1|Reported Event|BI 695500|Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.
168534|NCT01682460|B1|Baseline|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
168535|NCT01682460|P1|Participant Flow|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
168536|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
168537|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
168538|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
168539|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
168540|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
168541|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
168542|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
168543|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
168544|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
168545|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
168546|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
168547|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
168548|NCT01682460|E1|Reported Event|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
168549|NCT01682135|B4|Baseline|Total|Total of all reporting groups
168550|NCT01682135|B3|Baseline|Cohort 3 - 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
168551|NCT01682135|B2|Baseline|Cohort 2 - 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle) followed by dose escalation to Cohort 3. When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
168691|NCT01681472|O3|Outcome|6R-MTHF 200 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
168692|NCT01681472|O2|Outcome|Levoleucovorin 60 mg/m2|Levoleucovorin: i.v. bolus injection
168552|NCT01682135|B1|Baseline|Cohort 1 - 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle) followed by dose escalation to Cohort 2. When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
168553|NCT01682135|P3|Participant Flow|Cohort 3 - 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). After Cycle 1 treatment, participants who had an objective response or stable disease were permitted to receive ramucirumab at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met.
168554|NCT01682135|P2|Participant Flow|Cohort 2 - 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3. After Cycle 1 treatment, participants who had an objective response or stable disease were permitted to receive ramucirumab at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met.
168555|NCT01682135|P1|Participant Flow|Cohort 1 - 6 mg/kg/2w Ramucirumab|6 milligram per kilogram (mg/kg) ramucirumab administered intravenously (IV) every 2 weeks (w) for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2. After Cycle 1 treatment, participants who had an objective response or stable disease were permitted to receive ramucirumab at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met.
168556|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
168557|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
168558|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
168559|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
168560|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
168561|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
168562|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
168563|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
168564|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
168565|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
168566|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
168567|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
168568|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
168569|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
168570|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
168571|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
168572|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
168573|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
168574|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
168575|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
168576|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
168577|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
168578|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
168579|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
168580|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
168581|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
168582|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered intravenously (IV) every 2 weeks (w) for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
168583|NCT01682135|E3|Reported Event|Cohort 3 - 8mg/kg/2w Ramucirumab|8mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
168584|NCT01682135|E2|Reported Event|Cohort 2 - 10mg/kg/3w Ramucirumab|10mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
168585|NCT01682135|E1|Reported Event|Cohort 1 - 6mg/kg/2w Ramucirumab|6mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
168586|NCT01682044|B1|Baseline|Treatment (Colony-stimulating Factor and Monoclonal Antibody)|"Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.~pegfilgrastim: Given SC~rituximab: Given IV~flow cytometry: Correlative studies~biopsy: Correlative studies~immunohistochemistry staining method: Correlative studies~western blotting: Correlative studies"
168587|NCT01682044|P1|Participant Flow|Treatment (Colony-stimulating Factor and Monoclonal Antibody)|"Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.~pegfilgrastim: Given SC~rituximab: Given IV~flow cytometry: Correlative studies~biopsy: Correlative studies~immunohistochemistry staining method: Correlative studies~western blotting: Correlative studies"
168588|NCT01682044|O1|Outcome|Treatment (Colony-stimulating Factor and Monoclonal Antibody)|"Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.~pegfilgrastim: Given SC~rituximab: Given IV~flow cytometry: Correlative studies~biopsy: Correlative studies~immunohistochemistry staining method: Correlative studies~western blotting: Correlative studies"
168589|NCT01682044|O1|Outcome|Treatment (Colony-stimulating Factor and Monoclonal Antibody)|"Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.~pegfilgrastim: Given SC~rituximab: Given IV~flow cytometry: Correlative studies~biopsy: Correlative studies~immunohistochemistry staining method: Correlative studies~western blotting: Correlative studies"
168590|NCT01682044|O1|Outcome|Treatment (Colony-stimulating Factor and Monoclonal Antibody)|"Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.~pegfilgrastim: Given SC~rituximab: Given IV~flow cytometry: Correlative studies~biopsy: Correlative studies~immunohistochemistry staining method: Correlative studies~western blotting: Correlative studies"
168591|NCT01682044|O1|Outcome|Treatment (Colony-stimulating Factor and Monoclonal Antibody)|"Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.~pegfilgrastim: Given SC~rituximab: Given IV~flow cytometry: Correlative studies~biopsy: Correlative studies~immunohistochemistry staining method: Correlative studies~western blotting: Correlative studies"
168592|NCT01682044|O1|Outcome|Treatment (Colony-stimulating Factor and Monoclonal Antibody)|"Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.~pegfilgrastim: Given SC~rituximab: Given IV~flow cytometry: Correlative studies~biopsy: Correlative studies~immunohistochemistry staining method: Correlative studies~western blotting: Correlative studies"
168593|NCT01682044|O1|Outcome|Treatment (Colony-stimulating Factor and Monoclonal Antibody)|"Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.~pegfilgrastim: Given SC~rituximab: Given IV~flow cytometry: Correlative studies~biopsy: Correlative studies~immunohistochemistry staining method: Correlative studies~western blotting: Correlative studies"
168594|NCT01682044|O1|Outcome|Treatment (Colony-stimulating Factor and Monoclonal Antibody)|"Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.~pegfilgrastim: Given SC~rituximab: Given IV~flow cytometry: Correlative studies~biopsy: Correlative studies~immunohistochemistry staining method: Correlative studies~western blotting: Correlative studies"
168595|NCT01682044|E1|Reported Event|Treatment (Colony-stimulating Factor and Monoclonal Antibody)|"Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.~pegfilgrastim: Given SC~rituximab: Given IV~flow cytometry: Correlative studies~biopsy: Correlative studies~immunohistochemistry staining method: Correlative studies~western blotting: Correlative studies"
168596|NCT01682031|B3|Baseline|Total|Total of all reporting groups
168597|NCT01682031|B2|Baseline|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
168598|NCT01682031|B1|Baseline|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
168599|NCT01682031|P2|Participant Flow|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
168600|NCT01682031|P1|Participant Flow|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
168601|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
168602|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
168603|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
168604|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
168605|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
168606|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
168607|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
168608|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
168609|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
168610|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
168611|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
168612|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
168613|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
168614|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
168615|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
168616|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
168617|NCT01682031|E2|Reported Event|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
168618|NCT01682031|E1|Reported Event|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
168619|NCT01681849|B4|Baseline|Total|Total of all reporting groups
168620|NCT01681849|B3|Baseline|PTSD Negative|"Women who have experienced early childhood abuse and do not have PTSD served as a control group and completed baseline assessments~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
168621|NCT01681849|B2|Baseline|Placebo Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months.~Placebo: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
168622|NCT01681849|B1|Baseline|Paroxetine Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months.~Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
168623|NCT01681849|P3|Participant Flow|PTSD Negative|"Women who have experienced early childhood abuse and do not have PTSD served as a control group and completed baseline assessments~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
168624|NCT01681849|P2|Participant Flow|Placebo Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months.~Placebo: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
168625|NCT01681849|P1|Participant Flow|Paroxetine Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months.~Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
168626|NCT01681849|O2|Outcome|Placebo Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months.~Placebo: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
168627|NCT01681849|O1|Outcome|Paroxetine Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months.~Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
168628|NCT01681849|O2|Outcome|Placebo Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months.~Placebo: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
168629|NCT01681849|O1|Outcome|Paroxetine Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months.~Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
168630|NCT01681849|E3|Reported Event|PTSD Negative|"Women who have experienced early childhood abuse and do not have PTSD will serve as a control group and complete baseline assessments~Positron Emission Tomography (PET) Imaging: Participants will undergo positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
168693|NCT01681472|O1|Outcome|Levoleucovorin 200 mg/m2|Levoleucovorin: i.v. bolus injection
168694|NCT01681472|E4|Reported Event|6R-MTHF 60 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
168631|NCT01681849|E2|Reported Event|Placebo Group|"Women who have experienced early childhood abuse and have PTSD will be randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months.~Placebo: Following a three month double blind phase, subjects will be treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Paroxetine: Following a three month double blind phase, subjects will be treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants will undergo positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
168632|NCT01681849|E1|Reported Event|Paroxetine Group|"Women who have experienced early childhood abuse and have PTSD will be randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months.~Paroxetine: Following a three month double blind phase, subjects will be treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants will undergo positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
168633|NCT01681628|B3|Baseline|Total|Total of all reporting groups
168634|NCT01681628|B2|Baseline|Wait List|"Delayed intervention.~No intervention prior to assessment after one week (pre-test 2). Then treated with Thought Field Therapy, and re-assessed after a further week (post-test).~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.~Both groups were invited to attend 19 mo the later."
168635|NCT01681628|B1|Baseline|Thought Field Therapy (TFT)|"Thought Field Therapy delivered by trained community leaders.~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.~Both groups were invited to attend 19 months later"
168636|NCT01681628|P2|Participant Flow|Wait List|"Delayed intervention.~No intervention prior to assessment after one week (pre-test 2). Then treated with Thought Field Therapy, and re-assessed after a further week (post-test).~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
168637|NCT01681628|P1|Participant Flow|Thought Field Therapy|"Thought Field Therapy delivered by trained community leaders.~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
168638|NCT01681628|O1|Outcome|Wait List Group|Those in the wait list, who had attended for their second immediate pre-treatment assessment and attended for assessment 19 months later.
168639|NCT01681628|O1|Outcome|Thought Field Therapy|"Thought Field Therapy delivered by trained community leaders.~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
168640|NCT01681628|O3|Outcome|Wait List: Thought Field Therapy|After two control assessments at times 1 and 2, the wait list group were treated and re-assessed one week later at time 3. Non-attenders at time 3 were excluded from analysis.
168641|NCT01681628|O2|Outcome|Wait List no Treatment|"No intervention prior to assessment after one week (pre-test 2).~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
168642|NCT01681628|O1|Outcome|Thought Field Therapy|"Thought Field Therapy delivered by trained community leaders.~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
168643|NCT01681628|O3|Outcome|Wait-list: Thought Field Therapy|"Received thought field therapy after second assessment (time 2) and re-assessed one week later (time 3).~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
168644|NCT01681628|O2|Outcome|Wait List: no Therapy|"No thought field therapy intervention prior to assessment after one week (pre-test 2).~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
168645|NCT01681628|O1|Outcome|Thought Field Therapy|"Thought Field Therapy delivered by trained community leaders.~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
168646|NCT01681628|E1|Reported Event|Thought Field Therapy|"Thought Field Therapy delivered by trained community leaders.~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.~Both groups were invited to attend 19 months later"
168647|NCT01681576|B3|Baseline|Total|Total of all reporting groups
168648|NCT01681576|B2|Baseline|Valsartan 320mg|Period 1: 4 weeks treatment with Valsartan 320mg QD, 1-2 weeks wash-out, followed by period 2, 4 weeks treatment with LCZ696 400mg QD
168649|NCT01681576|B1|Baseline|LCZ696 Followed by Valsartan|Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks
168650|NCT01681576|P2|Participant Flow|Valsartan Followed by LCZ696|Period 1: Valsartan 320mg QD for 4 weeks then washout followed by Period 2: LCZ696 400mg QD for 4 weeks
168651|NCT01681576|P1|Participant Flow|LCZ696 Followed by Valsartan|Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks
168652|NCT01681576|O2|Outcome|Valsartan - ALL|Valsartan 320mg QD
168653|NCT01681576|O1|Outcome|LCZ696 - ALL|LCZ696 400mg
168654|NCT01681576|O2|Outcome|Valsartan - ALL|Valsartan 320mg QD
168665|NCT01681511|B2|Baseline|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
168666|NCT01681511|B1|Baseline|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
168667|NCT01681511|P2|Participant Flow|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
168668|NCT01681511|P1|Participant Flow|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
168669|NCT01681511|O2|Outcome|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
168670|NCT01681511|O1|Outcome|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
168671|NCT01681511|O2|Outcome|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
168672|NCT01681511|O1|Outcome|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
168673|NCT01681511|O2|Outcome|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
168674|NCT01681511|O1|Outcome|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
168675|NCT01681511|O2|Outcome|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
168676|NCT01681511|O1|Outcome|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
168677|NCT01681511|O2|Outcome|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
168678|NCT01681511|O1|Outcome|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
168679|NCT01681511|E2|Reported Event|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
168680|NCT01681511|E1|Reported Event|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
168681|NCT01681472|B5|Baseline|Total|Total of all reporting groups
168682|NCT01681472|B4|Baseline|6R-MTHF 60 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
168683|NCT01681472|B3|Baseline|6R-MTHF 200 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
168684|NCT01681472|B2|Baseline|Levoleucovorin 60 mg/m2|Levoleucovorin: i.v. bolus injection
168685|NCT01681472|B1|Baseline|Levoleucovorin 200 mg/m2|Levoleucovorin: i.v. bolus injection
168686|NCT01681472|P4|Participant Flow|6R-MTHF 60 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
168687|NCT01681472|P3|Participant Flow|6R-MTHF 200 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
168688|NCT01681472|P2|Participant Flow|Levoleucovorin 60 mg/m2|Levoleucovorin: i.v. bolus injection
168854|NCT01681004|B3|Baseline|Total|Total of all reporting groups
168695|NCT01681472|E3|Reported Event|6R-MTHF 200 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
168696|NCT01681472|E2|Reported Event|Levoleucovorin 60 mg/m2|Levoleucovorin: i.v. bolus injection
168697|NCT01681472|E1|Reported Event|Levoleucovorin 200 mg/m2|Levoleucovorin: i.v. bolus injection
168698|NCT01681368|B1|Baseline|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
168699|NCT01681368|P1|Participant Flow|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
168700|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
168701|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
168702|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
168703|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
168704|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
168705|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
168706|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
168707|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
168708|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
168709|NCT01681368|E1|Reported Event|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
168710|NCT01681277|B6|Baseline|Total|Total of all reporting groups
168711|NCT01681277|B5|Baseline|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
168712|NCT01681277|B4|Baseline|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168713|NCT01681277|B3|Baseline|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168714|NCT01681277|B2|Baseline|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168715|NCT01681277|B1|Baseline|Placebo|Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
168716|NCT01681277|P5|Participant Flow|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
168717|NCT01681277|P4|Participant Flow|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168718|NCT01681277|P3|Participant Flow|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168719|NCT01681277|P2|Participant Flow|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168720|NCT01681277|P1|Participant Flow|Placebo|Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
168721|NCT01681277|O4|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
183856|NCT01627002|O3|Outcome|Part B PA401 1.0 mg|
168722|NCT01681277|O3|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168723|NCT01681277|O2|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168724|NCT01681277|O1|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168725|NCT01681277|O4|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
168726|NCT01681277|O3|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168727|NCT01681277|O2|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168728|NCT01681277|O1|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168729|NCT01681277|O4|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
168730|NCT01681277|O3|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168731|NCT01681277|O2|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168732|NCT01681277|O1|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168733|NCT01681277|O4|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
168734|NCT01681277|O3|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168735|NCT01681277|O2|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168736|NCT01681277|O1|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168737|NCT01681277|O4|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
168738|NCT01681277|O3|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168739|NCT01681277|O2|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
183857|NCT01627002|O2|Outcome|Part A PA401 3.0 mg|
168740|NCT01681277|O1|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168741|NCT01681277|O4|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
168742|NCT01681277|O3|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168743|NCT01681277|O2|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168744|NCT01681277|O1|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168745|NCT01681277|O5|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
168746|NCT01681277|O4|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168747|NCT01681277|O3|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168748|NCT01681277|O2|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168749|NCT01681277|O1|Outcome|Placebo|Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
168750|NCT01681277|O5|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
168751|NCT01681277|O4|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168752|NCT01681277|O3|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168753|NCT01681277|O2|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168754|NCT01681277|O1|Outcome|Placebo|Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
168755|NCT01681277|E5|Reported Event|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
168756|NCT01681277|E4|Reported Event|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168757|NCT01681277|E3|Reported Event|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168758|NCT01681277|E2|Reported Event|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
168759|NCT01681277|E1|Reported Event|Placebo|Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
168760|NCT01681212|B1|Baseline|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
168761|NCT01681212|P1|Participant Flow|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression, unacceptable toxicity, or withdrawal of consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
168762|NCT01681212|O1|Outcome|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
168763|NCT01681212|O1|Outcome|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
168764|NCT01681212|O1|Outcome|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
168765|NCT01681212|E1|Reported Event|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
168766|NCT01681121|B3|Baseline|Total|Total of all reporting groups
168767|NCT01681121|B2|Baseline|Placebo|"Placebo to match ADX-N05 to be taken once a day for 12 weeks~Placebo: One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks"
168768|NCT01681121|B1|Baseline|ADX-N05|"ADX-N05 to be taken once a day for 12 weeks~ADX-N05: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks"
168769|NCT01681121|P2|Participant Flow|Placebo|"Placebo to match ADX-N05 to be taken once a day for 12 weeks~Placebo: One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks"
168770|NCT01681121|P1|Participant Flow|ADX-N05|"ADX-N05 to be taken once a day for 12 weeks~ADX-N05: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks"
168771|NCT01681121|O2|Outcome|Placebo|"Placebo to match ADX-N05 to be taken once a day for 12 weeks~Placebo: One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks"
168772|NCT01681121|O1|Outcome|ADX-N05|"ADX-N05 to be taken once a day for 12 weeks~ADX-N05: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks"
168773|NCT01681121|E2|Reported Event|Placebo|"Placebo to match ADX-N05 to be taken once a day for 12 weeks~Placebo: One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks"
168774|NCT01681121|E1|Reported Event|ADX-N05|"ADX-N05 to be taken once a day for 12 weeks~ADX-N05: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks"
168775|NCT01681095|B3|Baseline|Total|Total of all reporting groups
168889|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
168776|NCT01681095|B2|Baseline|Custiodiol HTK|"55 participants were randomized to Custodiol HTK. Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
168777|NCT01681095|B1|Baseline|Standard Cold Blood Cardioplegia|"55 participants were randomized to Standard cold blood cardioplegia. Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
168778|NCT01681095|P2|Participant Flow|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
168779|NCT01681095|P1|Participant Flow|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
168780|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
168781|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
168782|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
168783|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
168784|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
168855|NCT01681004|B2|Baseline|Non-Surgical Management|"Medications, SI joint injection, physical therapy and RF ablation of SI joint~Non-surgical management: Medications for pain, physical therapy, SI joint injection and RF ablation~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
168856|NCT01681004|B1|Baseline|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
168890|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
168785|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
168786|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
168787|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
168788|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
168789|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
168790|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
168791|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
168792|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
168793|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
168794|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
183858|NCT01627002|O1|Outcome|Part A PA401 1.0 mg|
168795|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
168796|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
168797|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
168798|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
168799|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
168800|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
168801|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
168802|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
168803|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
168804|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
183859|NCT01627002|O4|Outcome|Part B PA401 3.0 mg|
168805|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
168806|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
168807|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
168808|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
168809|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
168810|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
168811|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
168812|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
168813|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
168814|NCT01681095|E2|Reported Event|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
183860|NCT01627002|O3|Outcome|Part B PA401 1.0 mg|
168815|NCT01681095|E1|Reported Event|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
168816|NCT01681069|B3|Baseline|Total|Total of all reporting groups
168817|NCT01681069|B2|Baseline|Placebo|"2 tablets twice a day~Placebo"
168818|NCT01681069|B1|Baseline|IQP-VV-102|"2 tablets twice a day~IQP-VV-102"
168819|NCT01681069|P2|Participant Flow|Placebo|"2 tablets twice a day~Placebo"
168820|NCT01681069|P1|Participant Flow|IQP-VV-102|"2 tablets twice a day~IQP-VV-102"
168821|NCT01681069|O2|Outcome|Placebo|"2 tablets twice a day~Placebo"
168822|NCT01681069|O1|Outcome|IQP-VV-102|"2 tablets twice a day~IQP-VV-102"
168823|NCT01681069|O2|Outcome|Placebo|"2 tablets twice a day~Placebo"
168824|NCT01681069|O1|Outcome|IQP-VV-102|"2 tablets twice a day~IQP-VV-102"
168825|NCT01681069|O2|Outcome|Placebo|"2 tablets twice a day~Placebo"
168826|NCT01681069|O1|Outcome|IQP-VV-102|"2 tablets twice a day~IQP-VV-102"
168827|NCT01681069|E2|Reported Event|Placebo|"2 tablets twice a day~Placebo"
168828|NCT01681069|E1|Reported Event|IQP-VV-102|"2 tablets twice a day~IQP-VV-102"
168829|NCT01681030|B4|Baseline|Total|Total of all reporting groups
168830|NCT01681030|B3|Baseline|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.
168831|NCT01681030|B2|Baseline|Topical Hemostat|Equine collagen sponge with Human Fibrinogen and Human Thrombin
168832|NCT01681030|B1|Baseline|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
168833|NCT01681030|P3|Participant Flow|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.
168834|NCT01681030|P2|Participant Flow|Topical Hemostat|Equine collagen sponge with Human Fibrinogen and Human Thrombin
168835|NCT01681030|P1|Participant Flow|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
168836|NCT01681030|O3|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.
168837|NCT01681030|O2|Outcome|Topical Hemostat|Equine collagen sponge with Human Fibrinogen and Human Thrombin
168838|NCT01681030|O1|Outcome|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
168839|NCT01681030|O3|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.
168840|NCT01681030|O2|Outcome|Topical Hemostat|Equine collagen sponge with Human Fibrinogen and Human Thrombin
168841|NCT01681030|O1|Outcome|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
168842|NCT01681030|O3|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.
168843|NCT01681030|O2|Outcome|Topical Hemostat|Equine collagen sponge with Human Fibrinogen and Human Thrombin
168844|NCT01681030|O1|Outcome|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
168845|NCT01681030|O3|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.
168846|NCT01681030|O2|Outcome|Topical Hemostat|Equine collagen sponge with Human Fibrinogen and Human Thrombin
168847|NCT01681030|O1|Outcome|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
168848|NCT01681030|O3|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.
168849|NCT01681030|O2|Outcome|Topical Hemostat|Equine collagen sponge with Human Fibrinogen and Human Thrombin
168850|NCT01681030|O1|Outcome|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
168851|NCT01681030|E3|Reported Event|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.
168852|NCT01681030|E2|Reported Event|Topical Hemostat|Equine collagen sponge with Human Fibrinogen and Human Thrombin
168853|NCT01681030|E1|Reported Event|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
168857|NCT01681004|P2|Participant Flow|Non-Surgical Management|"Medications, SI joint injection, physical therapy and RF ablation of SI joint~Non-surgical management: Medications for pain, physical therapy, SI joint injection and RF ablation.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
168858|NCT01681004|P1|Participant Flow|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
168859|NCT01681004|O2|Outcome|Non-Surgical Management|This arm includes all subjects randomized to NSM. Many of these subjects crossed over to treatment after 6 months of NSM.
168860|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
168861|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
168862|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
168863|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
168864|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
168865|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
168866|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
168867|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
168868|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
168869|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
168870|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
168871|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
168872|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
168873|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months..~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
168874|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
168875|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
168876|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
168877|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
168878|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
168879|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
168880|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
168881|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
168882|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
168883|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
168884|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
168885|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
168886|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
168887|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
168888|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
169006|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm
168891|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
168892|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
168893|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
168894|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
168895|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
168896|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
168897|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
168898|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
168899|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
168900|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
168901|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
168902|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
168903|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
168904|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
168905|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
168906|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
168907|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM with reporting to 6 months only.~Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
168908|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint~iFuse Implant System: Placement of iFuse implant system via surgery"
168909|NCT01681004|E2|Reported Event|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months~Non-surgical management: Medications for pain, physical therapy, SI joint injection and RF ablation."
168910|NCT01681004|E1|Reported Event|iFuse Implant System|Surgical placement of iFuse implants in the affected SI joint iFuse Implant System: Placement of iFuse implant system via surgery
168911|NCT01680991|B4|Baseline|Total|Total of all reporting groups
168912|NCT01680991|B3|Baseline|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168913|NCT01680991|B2|Baseline|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168914|NCT01680991|B1|Baseline|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
168915|NCT01680991|P3|Participant Flow|FL: 1000 mg Obinutuzumab|Participants with follicular lymphoma (FL) received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168916|NCT01680991|P2|Participant Flow|DLBCL: 1000 mg Obinutuzumab|Participants with diffuse large B-cell lymphoma (DLBCL) received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168917|NCT01680991|P1|Participant Flow|CLL: 1000 mg Obinutuzumab|Participants with chronic lymphocytic leukemia (CLL) received 1000 milligrams (mg) obinutuzumab as an intravenous (IV) infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
168918|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168919|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168920|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
183861|NCT01627002|O2|Outcome|Part A PA401 3.0 mg|
168921|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168922|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168923|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
168924|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168925|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168926|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
168927|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168928|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168929|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
168930|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168931|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168932|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
168933|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
168934|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
168935|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
168936|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
168937|NCT01680991|O2|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168938|NCT01680991|O1|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168939|NCT01680991|O2|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168940|NCT01680991|O1|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168941|NCT01680991|O2|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168942|NCT01680991|O1|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168943|NCT01680991|O2|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168944|NCT01680991|O1|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
169007|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm
169008|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm
168945|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168946|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168947|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
168948|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168949|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168950|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
168951|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168952|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168953|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
168954|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168955|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168956|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
168957|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168958|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168959|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
168960|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168961|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168962|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
168963|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168964|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168965|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
168966|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168967|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168968|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
169009|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm.
169010|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm.
168969|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168970|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168971|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
168972|NCT01680991|E3|Reported Event|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168973|NCT01680991|E2|Reported Event|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
168974|NCT01680991|E1|Reported Event|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
168975|NCT01680900|B3|Baseline|Total|Total of all reporting groups
168976|NCT01680900|B2|Baseline|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
168977|NCT01680900|B1|Baseline|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
168978|NCT01680900|P2|Participant Flow|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
168979|NCT01680900|P1|Participant Flow|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
168980|NCT01680900|O2|Outcome|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
168981|NCT01680900|O1|Outcome|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
168982|NCT01680900|O2|Outcome|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
168983|NCT01680900|O1|Outcome|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
168984|NCT01680900|O2|Outcome|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
168985|NCT01680900|O1|Outcome|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
168986|NCT01680900|O2|Outcome|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
168987|NCT01680900|O1|Outcome|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
168988|NCT01680900|O2|Outcome|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
168989|NCT01680900|O1|Outcome|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
168990|NCT01680900|O2|Outcome|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
168991|NCT01680900|O1|Outcome|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
168992|NCT01680900|E2|Reported Event|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
168993|NCT01680900|E1|Reported Event|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
168994|NCT01680861|B3|Baseline|Total|Total of all reporting groups
168995|NCT01680861|B2|Baseline|Tacrolimus/EC-MPS|our standard maintenance arm.
168996|NCT01680861|B1|Baseline|Tacrolimus/Everolimus|our experimental maintenance arm.
168997|NCT01680861|P2|Participant Flow|Tacrolimus/EC-MPS|our standard maintenance arm: Target 12-hr Tacrolimus trough level: 5-8 ng/mL Target EC-MPS dose: 720 mg PO BID (as tolerated).
168998|NCT01680861|P1|Participant Flow|Tacrolimus/Everolimus|our experimental maintenance arm: Target 12-hr Tacrolimus trough level: 5-8 ng/mL Target 12-hr Everolimus trough level: 3-8 ng/mL.
168999|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm
169000|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm
169001|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm
169002|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm
169003|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm
169004|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm
169005|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm
169011|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm.
169012|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm.
169013|NCT01680861|E2|Reported Event|Tacrolimus/EC-MPS|our standard maintenance arm
169014|NCT01680861|E1|Reported Event|Tacrolimus/Everolimus|our experimental maintenance arm
169015|NCT01680848|B1|Baseline|JDPBRN Dentists|"Dentists working in outpatient dental practice (n=282) who were affiliated with the JDPBRN and who indicated that they do at least some restorative dentistry.~The JDPBRN aims to allow dentists to investigate research questions and share experiences and expertise and recruited its members from the JDPBRN website."
169016|NCT01680848|P1|Participant Flow|JDPBRN Dentists|Dentists working in outpatient dental practice (n=282) who were affiliated with the JDPBRN and who indicated that they do at least some restorative dentistry.
169017|NCT01680848|O1|Outcome|High Caries Risk|The proportion of dentists who indicated surgical intervention into enamel was 74% (N = 138) in the high-caries-risk scenario.
169018|NCT01680848|E1|Reported Event|This is an Observational Study|This is an observational study. We don't have two arms.
169019|NCT01680783|B3|Baseline|Total|Total of all reporting groups
169020|NCT01680783|B2|Baseline|Non Invasive Ventilation Via Helmet|"Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure~Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.~If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay."
169021|NCT01680783|B1|Baseline|Usual Care|"Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.~Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask"
169022|NCT01680783|P2|Participant Flow|Non Invasive Ventilation Via Helmet|"Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure~Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.~If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay."
169023|NCT01680783|P1|Participant Flow|Usual Care|"Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.~Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask"
169024|NCT01680783|O2|Outcome|Non Invasive Ventilation Via Helmet|"Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure~Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.~If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay."
169025|NCT01680783|O1|Outcome|Usual Care|"Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.~Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask"
169026|NCT01680783|E2|Reported Event|Non Invasive Ventilation Via Helmet|"Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure~Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.~If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay."
169027|NCT01680783|E1|Reported Event|Usual Care|"Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.~Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask"
169028|NCT01680666|B3|Baseline|Total|Total of all reporting groups
169029|NCT01680666|B2|Baseline|Ultrasound Guided|In the ultrasound-guided group, the internal jugular vein on either side was accessed depending on surgeon’s preference. An ultrasound console with a linear 11 Hz probe was used. The patient was then put into Trendelenburg position. The head was positioned away from the insertion side. The ultrasound probe was placed at the apex of the triangle formed between the two heads of the sternocleidomastoid muscle and the clavicle. The internal jugular vein and common carotid artery were visualized, with the vein identified by its larger size, relative anatomic position, and compressibility. After a flashback of dark venous blood was noted in the syringe, the standard Seldinger technique was followed for the catheter insertion. After 3 failed attempts using the ultrasound at the specified site, the surgeon was free to further attempts using landmark or ultrasound approaches at any other site.
169030|NCT01680666|B1|Baseline|Landmark Guided|In the landmark technique, the subclavian vein or the internal jugular vein on either side was chosen for access depending on surgeon’s preference. An infraclavicular approach was used for the subclavian vein, and an anterior approach was used for the internal jugular vein. If venous flash could not be achieved after three attempts on the initial chosen site using the landmark technique, the study was terminated and the surgeon was free to use either ultrasound or landmark at any other site. A single pass of the needle was defined as a single episode of needle advancement and withdrawal. A second pass occurred if the needle was re-advanced or removed and reinserted. A failed attempt was recorded if aspiration resulted in no venous flash, arterial puncture (bright red blood, pulsatile flow), or air.
169116|NCT01680328|O5|Outcome|Injection Speed at 450 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
169178|NCT01680159|E10|Reported Event|TA-650（Entire Evaluation Period）Psoriatic Arthritis|Psoriatic Arthritis
169031|NCT01680666|P2|Participant Flow|Ultrasound Guided|In the ultrasound-guided group, the internal jugular vein on either side was accessed depending on surgeon’s preference. An ultrasound console with a linear 11 Hz probe was used. The patient was then put into Trendelenburg position. The head was positioned away from the insertion side. The ultrasound probe was placed at the apex of the triangle formed between the two heads of the sternocleidomastoid muscle and the clavicle. The internal jugular vein and common carotid artery were visualized, with the vein identified by its larger size, relative anatomic position, and compressibility. After a flashback of dark venous blood was noted in the syringe, the standard Seldinger technique was followed for the catheter insertion. After 3 failed attempts using the ultrasound at the specified site, the surgeon was free to further attempts using landmark or ultrasound approaches at any other site.
169032|NCT01680666|P1|Participant Flow|Landmark Guided|In the landmark technique, the subclavian vein or the internal jugular vein on either side was chosen for access depending on surgeon’s preference. An infraclavicular approach was used for the subclavian vein, and an anterior approach was used for the internal jugular vein. If venous flash could not be achieved after three attempts on the initial chosen site using the landmark technique, the study was terminated and the surgeon was free to use either ultrasound or landmark at any other site. A single pass of the needle was defined as a single episode of needle advancement and withdrawal. A second pass occurred if the needle was re-advanced or removed and reinserted. A failed attempt was recorded if aspiration resulted in no venous flash, arterial puncture (bright red blood, pulsatile flow), or air.
169033|NCT01680666|O2|Outcome|Ultrasound Guided|In the ultrasound-guided group, the internal jugular vein on either side was accessed depending on surgeon’s preference. An ultrasound console with a linear 11 Hz probe was used. The patient was then put into Trendelenburg position. The head was positioned away from the insertion side. The ultrasound probe was placed at the apex of the triangle formed between the two heads of the sternocleidomastoid muscle and the clavicle. The internal jugular vein and common carotid artery were visualized, with the vein identified by its larger size, relative anatomic position, and compressibility. After a flashback of dark venous blood was noted in the syringe, the standard Seldinger technique was followed for the catheter insertion. After 3 failed attempts using the ultrasound at the specified site, the surgeon was free to further attempts using landmark or ultrasound approaches at any other site.
169034|NCT01680666|O1|Outcome|Landmark Guided|In the landmark technique, the subclavian vein or the internal jugular vein on either side was chosen for access depending on surgeon’s preference. An infraclavicular approach was used for the subclavian vein, and an anterior approach was used for the internal jugular vein. If venous flash could not be achieved after three attempts on the initial chosen site using the landmark technique, the study was terminated and the surgeon was free to use either ultrasound or landmark at any other site. A single pass of the needle was defined as a single episode of needle advancement and withdrawal. A second pass occurred if the needle was re-advanced or removed and reinserted. A failed attempt was recorded if aspiration resulted in no venous flash, arterial puncture (bright red blood, pulsatile flow), or air.
169035|NCT01680666|O2|Outcome|Ultrasound Guided|In the ultrasound-guided group, the internal jugular vein on either side was accessed depending on surgeon’s preference. An ultrasound console with a linear 11 Hz probe was used. The patient was then put into Trendelenburg position. The head was positioned away from the insertion side. The ultrasound probe was placed at the apex of the triangle formed between the two heads of the sternocleidomastoid muscle and the clavicle. The internal jugular vein and common carotid artery were visualized, with the vein identified by its larger size, relative anatomic position, and compressibility. After a flashback of dark venous blood was noted in the syringe, the standard Seldinger technique was followed for the catheter insertion. After 3 failed attempts using the ultrasound at the specified site, the surgeon was free to further attempts using landmark or ultrasound approaches at any other site.
169036|NCT01680666|O1|Outcome|Landmark Guided|In the landmark technique, the subclavian vein or the internal jugular vein on either side was chosen for access depending on surgeon’s preference. An infraclavicular approach was used for the subclavian vein, and an anterior approach was used for the internal jugular vein. If venous flash could not be achieved after three attempts on the initial chosen site using the landmark technique, the study was terminated and the surgeon was free to use either ultrasound or landmark at any other site. A single pass of the needle was defined as a single episode of needle advancement and withdrawal. A second pass occurred if the needle was re-advanced or removed and reinserted. A failed attempt was recorded if aspiration resulted in no venous flash, arterial puncture (bright red blood, pulsatile flow), or air.
169037|NCT01680666|O2|Outcome|Ultrasound Guided|In the ultrasound-guided group, the internal jugular vein on either side was accessed depending on surgeon’s preference. An ultrasound console with a linear 11 Hz probe was used. The patient was then put into Trendelenburg position. The head was positioned away from the insertion side. The ultrasound probe was placed at the apex of the triangle formed between the two heads of the sternocleidomastoid muscle and the clavicle. The internal jugular vein and common carotid artery were visualized, with the vein identified by its larger size, relative anatomic position, and compressibility. After a flashback of dark venous blood was noted in the syringe, the standard Seldinger technique was followed for the catheter insertion. After 3 failed attempts using the ultrasound at the specified site, the surgeon was free to further attempts using landmark or ultrasound approaches at any other site.
169038|NCT01680666|O1|Outcome|Landmark Guided|In the landmark technique, the subclavian vein or the internal jugular vein on either side was chosen for access depending on surgeon’s preference. An infraclavicular approach was used for the subclavian vein, and an anterior approach was used for the internal jugular vein. If venous flash could not be achieved after three attempts on the initial chosen site using the landmark technique, the study was terminated and the surgeon was free to use either ultrasound or landmark at any other site. A single pass of the needle was defined as a single episode of needle advancement and withdrawal. A second pass occurred if the needle was re-advanced or removed and reinserted. A failed attempt was recorded if aspiration resulted in no venous flash, arterial puncture (bright red blood, pulsatile flow), or air.
169117|NCT01680328|O4|Outcome|Injection Volume 400 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
169179|NCT01680159|E9|Reported Event|TA-650（Entire Evaluation Period）Plaque Psoriasis|Plaque Psoriasis
169039|NCT01680666|O2|Outcome|Ultrasound Guided|In the ultrasound-guided group, the internal jugular vein on either side was accessed depending on surgeon’s preference. An ultrasound console with a linear 11 Hz probe was used. The patient was then put into Trendelenburg position. The head was positioned away from the insertion side. The ultrasound probe was placed at the apex of the triangle formed between the two heads of the sternocleidomastoid muscle and the clavicle. The internal jugular vein and common carotid artery were visualized, with the vein identified by its larger size, relative anatomic position, and compressibility. After a flashback of dark venous blood was noted in the syringe, the standard Seldinger technique was followed for the catheter insertion. After 3 failed attempts using the ultrasound at the specified site, the surgeon was free to further attempts using landmark or ultrasound approaches at any other site.
169040|NCT01680666|O1|Outcome|Landmark Guided|In the landmark technique, the subclavian vein or the internal jugular vein on either side was chosen for access depending on surgeon’s preference. An infraclavicular approach was used for the subclavian vein, and an anterior approach was used for the internal jugular vein. If venous flash could not be achieved after three attempts on the initial chosen site using the landmark technique, the study was terminated and the surgeon was free to use either ultrasound or landmark at any other site. A single pass of the needle was defined as a single episode of needle advancement and withdrawal. A second pass occurred if the needle was re-advanced or removed and reinserted. A failed attempt was recorded if aspiration resulted in no venous flash, arterial puncture (bright red blood, pulsatile flow), or air.
169041|NCT01680666|O2|Outcome|Ultrasound Guided|In the ultrasound-guided group, the internal jugular vein on either side was accessed depending on surgeon’s preference. An ultrasound console with a linear 11 Hz probe was used. The patient was then put into Trendelenburg position. The head was positioned away from the insertion side. The ultrasound probe was placed at the apex of the triangle formed between the two heads of the sternocleidomastoid muscle and the clavicle. The internal jugular vein and common carotid artery were visualized, with the vein identified by its larger size, relative anatomic position, and compressibility. After a flashback of dark venous blood was noted in the syringe, the standard Seldinger technique was followed for the catheter insertion. After 3 failed attempts using the ultrasound at the specified site, the surgeon was free to further attempts using landmark or ultrasound approaches at any other site.
169042|NCT01680666|O1|Outcome|Landmark Technique|In the landmark technique, the subclavian vein or the internal jugular vein on either side was chosen for access depending on surgeon’s preference. An infraclavicular approach was used for the subclavian vein, and an anterior approach was used for the internal jugular vein. If venous flash could not be achieved after three attempts on the initial chosen site using the landmark technique, the study was terminated and the surgeon was free to use either ultrasound or landmark at any other site. A single pass of the needle was defined as a single episode of needle advancement and withdrawal. A second pass occurred if the needle was re-advanced or removed and reinserted. A failed attempt was recorded if aspiration resulted in no venous flash, arterial puncture (bright red blood, pulsatile flow), or air.
169043|NCT01680666|E2|Reported Event|Ultrasound Guided|In the ultrasound-guided group, the internal jugular vein on either side was accessed depending on surgeon’s preference. An ultrasound console with a linear 11 Hz probe was used. The patient was then put into Trendelenburg position. The head was positioned away from the insertion side. The ultrasound probe was placed at the apex of the triangle formed between the two heads of the sternocleidomastoid muscle and the clavicle. The internal jugular vein and common carotid artery were visualized, with the vein identified by its larger size, relative anatomic position, and compressibility. After a flashback of dark venous blood was noted in the syringe, the standard Seldinger technique was followed for the catheter insertion. After 3 failed attempts using the ultrasound at the specified site, the surgeon was free to further attempts using landmark or ultrasound approaches at any other site.
169044|NCT01680666|E1|Reported Event|Landmark Guided|In the landmark technique, the subclavian vein or the internal jugular vein on either side was chosen for access depending on surgeon’s preference. An infraclavicular approach was used for the subclavian vein, and an anterior approach was used for the internal jugular vein. If venous flash could not be achieved after three attempts on the initial chosen site using the landmark technique, the study was terminated and the surgeon was free to use either ultrasound or landmark at any other site. A single pass of the needle was defined as a single episode of needle advancement and withdrawal. A second pass occurred if the needle was re-advanced or removed and reinserted. A failed attempt was recorded if aspiration resulted in no venous flash, arterial puncture (bright red blood, pulsatile flow), or air.
169045|NCT01680653|B1|Baseline|All Participants|The subjects were enrolled at three camps for diabetes; from each camp approximately 20 subjects were enrolled. There were two locations, one hosting two sessions. Each camp was approximately 5-6 days in length. Campers wore a continuous glucose sensor every day they were in the study. On alternate nights they had remote monitoring, this defined the primary treatment arms: remote monitoring or no remote monitoring. On alternating days of remote monitoring hypoglycemia was treated with either mini glucagon or carbohydrates, this was a secondary randomization.
169046|NCT01680653|P1|Participant Flow|All Participants|The subjects participated in three camps; each camp had approximately 20 subjects. There were two locations, one hosting two sessions. Each camp was approximately 5-6 days in length. Campers wore the device on alternating days, and hypoglycemia was treated with either mini glucagon or carbohydrates.
169047|NCT01680653|O2|Outcome|Control|Subjects who were not being remotely monitored (not on the device)
169048|NCT01680653|O1|Outcome|Remote Monitoring|Subjects who were on the device during the night (remotely monitored)
169049|NCT01680653|O2|Outcome|Control (no Remote Monitoring)|Subjects glucose data are remotely monitored at night using the University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform. Study staff intervenes with a fingerstick blood glucose measurement when sensor value falls below 70mg/dL. If fingerstick value is less than 70 mg/dL, hypoglycemic treatment is administered as below.
169050|NCT01680653|O1|Outcome|Remote Monitoring|"Subjects glucose data are remotely monitored at night using the University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform. Study staff intervenes with a fingerstick blood glucose measurement when sensor value falls below 70mg/dL. If fingerstick value is less than 70 mg/dL, hypoglycemic treatment is administered as below.~Remote monitoring: Provides real-time continuous glucose monitoring"
169177|NCT01680159|O1|Outcome|Overall|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
169051|NCT01680653|O2|Outcome|Control|"Subjects glucose data are remotely monitored at night using the University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform. Study staff intervenes with a fingerstick blood glucose measurement when sensor value falls below 70mg/dL. If fingerstick value is less than 70 mg/dL, hypoglycemic treatment is administered as below.~Administration of carbohydrate per camp protocol to treat nocturnal hypoglycemia. Expected treatment is 15-45g.~Remote monitoring: Provides real-time continuous glucose monitoring~Carbohydrates and remote monitoring: 16 grams of carbohydrate with remote monitoring"
169052|NCT01680653|O1|Outcome|Remote Monitoring|"Subjects glucose data are remotely monitored at night using the University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform. Study staff intervenes with a fingerstick blood glucose measurement when sensor value falls below 70mg/dL. If fingerstick value is less than 70 mg/dL, hypoglycemic treatment is administered as below.~Administer mini-glucagon as treatment for nocturnal hypoglycemia. Administer 0.01 cc per number of years in age via insulin syringe, subcutaneously. This amounts to 1 unit per age, for example: an 8 year old gets 8 units glucagon.~Mini-glucagon: Mini dose glucagon given for glucose <70 mg/dl at a dose of 1unit/year of age~Remote monitoring: Provides real-time continuous glucose monitoring"
169053|NCT01680653|E2|Reported Event|Control (no Remote Monitoring)|All participants; during the study, each subject was randomized to either the control or the remote monitoring group, and then alternated on subsequent nights.
169054|NCT01680653|E1|Reported Event|Remote Monitoring|All participants; during the study, each subject was randomized to either the control or the remote monitoring group, and then alternated on subsequent nights.
169055|NCT01680549|B3|Baseline|Total|Total of all reporting groups
169056|NCT01680549|B2|Baseline|Placebo|"Placebo 600 mg po preoperatively and continued postoperatively 300 mg po q8hours X 3 days~Gabapentin: Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days."
169057|NCT01680549|B1|Baseline|Gabapentin|"Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.~Gabapentin: Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days."
169058|NCT01680549|P2|Participant Flow|Placebo|Placebo 1 tab PO preoperatively and 1 tab PO continued postoperatively q8hours X 3 days
169059|NCT01680549|P1|Participant Flow|Gabapentin|Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
169060|NCT01680549|O2|Outcome|Gabapentin|Active pain control medicine
169061|NCT01680549|O1|Outcome|Placebo|Placebo comparator
169062|NCT01680549|O2|Outcome|Gabapentin|Active pain control Medicine
169063|NCT01680549|O1|Outcome|Placebo|Placebo- comparator
169064|NCT01680549|O2|Outcome|Placebo|Placebo 1 tab PO preoperatively and 1 tab PO continued postoperatively q8hours X 3 days
169065|NCT01680549|O1|Outcome|Gabapentin|Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
169066|NCT01680549|O2|Outcome|Gabapentin|Active pain medicine
169067|NCT01680549|O1|Outcome|Placebo|Placebo- Comparator
169068|NCT01680549|E2|Reported Event|Gabapentin|Active pain control medicine
169069|NCT01680549|E1|Reported Event|Placebo|placebo comparator
169070|NCT01680497|B1|Baseline|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
169071|NCT01680497|P1|Participant Flow|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
169072|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
169073|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
169074|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
169075|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
169076|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
169077|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
169078|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
169079|NCT01680497|E1|Reported Event|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
169080|NCT01680458|B1|Baseline|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
169081|NCT01680458|P1|Participant Flow|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
169082|NCT01680458|O1|Outcome|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
169083|NCT01680458|O1|Outcome|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
169084|NCT01680458|O1|Outcome|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
169085|NCT01680458|O1|Outcome|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
169086|NCT01680458|O1|Outcome|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
169087|NCT01680458|O1|Outcome|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
169088|NCT01680458|E1|Reported Event|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
169089|NCT01680341|B3|Baseline|Total|Total of all reporting groups
169090|NCT01680341|B2|Baseline|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
169091|NCT01680341|B1|Baseline|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
169092|NCT01680341|P2|Participant Flow|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
169093|NCT01680341|P1|Participant Flow|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
169094|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
169095|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
169096|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
169097|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
169098|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
169099|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
169100|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
169101|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
169102|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
169118|NCT01680328|O3|Outcome|Injection Volume 800 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
169103|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
169104|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
169105|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
169106|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
169107|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
169108|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
169109|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
169110|NCT01680341|E2|Reported Event|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
169111|NCT01680341|E1|Reported Event|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
169112|NCT01680328|B1|Baseline|All Participants|Subjects received 19 subcutaneous (s.c) injections. Of the 19 injections, 13 were in the abdomen and 6 in the thighs. Of the 13 injections in the abdomen, 1 was a needle insertion and 12 were combinations of the 4 different injection volumes (400, 800, 1200 and 1600 µL) and 3 injection speeds (150, 300 and 450 µL/s). Of the 6 injections in the thigh, 1 was a needle insertion and 5 were selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). Except for the 2 needle insertions, sodium chloride 0.9% solution was injected.
169113|NCT01680328|P1|Participant Flow|All Participants|Subjects received 19 subcutaneous (s.c) injections. Of the 19 injections, 13 were in the abdomen and 6 in the thighs. Of the 13 injections in the abdomen, 1 was a needle insertion and 12 were combinations of the 4 different injection volumes (400, 800, 1200 and 1600 µL) and 3 injection speeds (150, 300 and 450 µL/s). Of the 6 injections in the thigh, 1 was a needle insertion and 5 were selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). Except for the 2 needle insertions, sodium chloride 0.9% solution was injected.
169114|NCT01680328|O7|Outcome|Injection Speed at 150 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
169115|NCT01680328|O6|Outcome|Injection Speed at 300 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
169360|NCT01679002|O2|Outcome|BIA 2-093 450 mg Bid|ESL, Eslicarbazepine acetate BIA 2-093 450 mg bid
169119|NCT01680328|O2|Outcome|Injection Volume 1600 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
169120|NCT01680328|O1|Outcome|Thighs: Injection Region-5 s.c Injections+1 Needle Insertion|Backflow (uL) was assessed in each subject for the 5 s.c injections+1 needle insertion administered in the thighs.
169121|NCT01680328|O8|Outcome|Injection Speed at 150 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
169122|NCT01680328|O7|Outcome|Injection Speed at 300 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
169123|NCT01680328|O6|Outcome|Injection Speed at 450 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
169124|NCT01680328|O5|Outcome|Injection Volume 400 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
169125|NCT01680328|O4|Outcome|Injection Volume 800 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
169126|NCT01680328|O3|Outcome|Injection Volume 1200 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
169127|NCT01680328|O2|Outcome|Injection Volume 1600 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
169128|NCT01680328|O1|Outcome|Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion|Backflow (uL) was assessed in each subject for the 12 s.c injections+1 needle insertion administered in the abdomen.
169129|NCT01680328|O2|Outcome|Abdomen|Acceptance of pain was assessed in each subject for all injections in the abdomen.
169130|NCT01680328|O1|Outcome|Thighs|Acceptance of pain was assessed in each subject for all injections in the thighs.
169131|NCT01680328|O3|Outcome|Injection Speed at 150 μL/s|Acceptance of pain was assessed in each subject for all injections.
169132|NCT01680328|O2|Outcome|Injection Speed at 300 μL/s|Acceptance of pain was assessed in each subject for all injections.
169133|NCT01680328|O1|Outcome|Injection Speed at 450 μL/s|Acceptance of pain was assessed in each subject for all injections.
169134|NCT01680328|O4|Outcome|Injection Volume of 400 μL|Acceptance of pain was assessed in each subject for all injections.
169135|NCT01680328|O3|Outcome|Injection Volume of 800 μL|Acceptance of pain was assessed in each subject for all injections.
169136|NCT01680328|O2|Outcome|Injection Volume of 1200 μL|Acceptance of pain was assessed in each subject for all injections.
169137|NCT01680328|O1|Outcome|Injection Volume of 1600 μL|Acceptance of pain was assessed in each subject for all injections.
169138|NCT01680328|O9|Outcome|Injection Speed at 150 μL/s|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
169139|NCT01680328|O8|Outcome|Injection Speed at 300 μL/s|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
169140|NCT01680328|O7|Outcome|Injection Speed at 450 μL/s|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
169141|NCT01680328|O6|Outcome|Injection Volume 400 μL|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
169142|NCT01680328|O5|Outcome|Injection Volume 800 μL|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
169143|NCT01680328|O4|Outcome|Injection Volume 1200 μL|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
183862|NCT01627002|O1|Outcome|Part A PA401 1.0 mg|
169144|NCT01680328|O3|Outcome|Injection Volume 1600 μL|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
169145|NCT01680328|O2|Outcome|Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion|Pain (VAS) was assessed in each subject for the 12 s.c injections+1 needle insertion administered in the abdomen.
169146|NCT01680328|O1|Outcome|Thighs: Injection Region-5 s.c Injections+1 Needle Insertion|Pain (VAS) was assessed in each subject for the 5 s.c injections+1 needle insertion administered in the thighs.
169147|NCT01680328|E1|Reported Event|All Participants|Subjects received 19 subcutaneous (s.c) injections. Of the 19 injections, 13 were in the abdomen and 6 in the thighs. Of the 13 injections in the abdomen, 1 was a needle insertion and 12 were combinations of the 4 different injection volumes (400, 800, 1200 and 1600 µL) and 3 injection speeds (150, 300 and 450 µL/s). Of the 6 injections in the thigh, 1 was a needle insertion and 5 were selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). Except for the 2 needle insertions, sodium chloride 0.9% solution was injected.
169148|NCT01680172|B3|Baseline|Total|Total of all reporting groups
169149|NCT01680172|B2|Baseline|Placebo|"Single dose of placebo~Placebo: Single dose of placebo"
169150|NCT01680172|B1|Baseline|Ketamine|"Single dose of ketamine (0.5 mg/kg)~Ketamine: Single dose of ketamine (0.5 mg/kg)"
169151|NCT01680172|P2|Participant Flow|Placebo|"Single dose of placebo~Placebo: Single dose of placebo"
169152|NCT01680172|P1|Participant Flow|Ketamine|"Single dose of ketamine (0.5 mg/kg)~Ketamine: Single dose of ketamine (0.5 mg/kg)"
169153|NCT01680172|O2|Outcome|Placebo|"Single dose of placebo~Placebo: Single dose of placebo"
169154|NCT01680172|O1|Outcome|Ketamine|"Single dose of ketamine (0.5 mg/kg)~Ketamine: Single dose of ketamine (0.5 mg/kg)"
169155|NCT01680172|O2|Outcome|Placebo|"Single dose of placebo~Placebo: Single dose of placebo"
169156|NCT01680172|O1|Outcome|Ketamine|"Single dose of ketamine (0.5 mg/kg)~Ketamine: Single dose of ketamine (0.5 mg/kg)"
169157|NCT01680172|E2|Reported Event|Placebo|"Single dose of placebo~Placebo: Single dose of placebo"
169158|NCT01680172|E1|Reported Event|Ketamine|"Single dose of ketamine (0.5 mg/kg)~Ketamine: Single dose of ketamine (0.5 mg/kg)"
169159|NCT01680159|B5|Baseline|Total|Total of all reporting groups
169160|NCT01680159|B4|Baseline|Psoriatic Erythroderma|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
169161|NCT01680159|B3|Baseline|Pustular Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
169162|NCT01680159|B2|Baseline|Psoriatic Arthritis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
169163|NCT01680159|B1|Baseline|Plaque Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
169164|NCT01680159|P1|Participant Flow|TA-650|During the normal dose period, patients received doses of TA-650 5 mg per 1 kg body weight as a slow intravenous infusion over at least 2 hours on the treatment day at week 0, and at week 8 (if patients were not assessed as being either “efficacy attenuated” or “efficacy maintained” at week 8 of the normal dose period).
169165|NCT01680159|O1|Outcome|Pustular Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
169166|NCT01680159|O1|Outcome|Psoriatic Arthritis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
169167|NCT01680159|O1|Outcome|Plaque Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
169168|NCT01680159|O5|Outcome|Psoriatic Erythroderma|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
169169|NCT01680159|O4|Outcome|Pustular Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
169170|NCT01680159|O3|Outcome|Psoriatic Arthritis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
169171|NCT01680159|O2|Outcome|Plaque Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
169172|NCT01680159|O1|Outcome|Overall|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
169173|NCT01680159|O5|Outcome|Psoriatic Erythroderma|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
169174|NCT01680159|O4|Outcome|Pustular Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
169175|NCT01680159|O3|Outcome|Psoriatic Arthritis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
169176|NCT01680159|O2|Outcome|Plaque Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
169180|NCT01680159|E8|Reported Event|TA-650（Dose Escalation Period）Psoriatic Erythroderma|Psoriatic Erythroderma
169181|NCT01680159|E7|Reported Event|TA-650（Dose Escalation Period）Pustular Psoriasis|Pustular Psoriasis
169182|NCT01680159|E6|Reported Event|TA-650（Dose Escalation Period）Psoriatic Arthritis|Psoriatic Arthritis
169183|NCT01680159|E5|Reported Event|TA-650（Dose Escalation Period）Plaque Psoriasis|Plaque Psoriasis
169184|NCT01680159|E4|Reported Event|TA-650（Dose Escalation Period）Overall|Overall(Plaque Psoriasis・Psoriatic Arthritis・Pustular Psoriasis・Psoriatic Erythroderma)
169185|NCT01680159|E3|Reported Event|TA-650（Normal Dose Period）Psoriatic Arthritis|Psoriatic Arthritis
169186|NCT01680159|E2|Reported Event|TA-650（Normal Dose Period）Plaque Psoriasis|Plaque Psoriasis
169187|NCT01680159|E1|Reported Event|TA-650（Normal Dose Period）Overall|Overall(Plaque Psoriasis・Psoriatic Arthritis)
169188|NCT01680016|B3|Baseline|Total|Total of all reporting groups
169189|NCT01680016|B2|Baseline|Essen|Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169190|NCT01680016|B1|Baseline|Zagreb|Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
169191|NCT01680016|P4|Participant Flow|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169192|NCT01680016|P3|Participant Flow|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
169193|NCT01680016|P2|Participant Flow|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169194|NCT01680016|P1|Participant Flow|Zagreb(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
169195|NCT01680016|O2|Outcome|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169196|NCT01680016|O1|Outcome|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
169197|NCT01680016|O2|Outcome|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169198|NCT01680016|O1|Outcome|Zagreb(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
169199|NCT01680016|O6|Outcome|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169200|NCT01680016|O5|Outcome|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
169201|NCT01680016|O4|Outcome|Essen(≥61 Years)|≥61 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169202|NCT01680016|O3|Outcome|Zagreb(≥61 Years)|≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
169203|NCT01680016|O2|Outcome|Essen(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169204|NCT01680016|O1|Outcome|Zagreb(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
169205|NCT01680016|O6|Outcome|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169206|NCT01680016|O5|Outcome|Zagreb( ≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
169207|NCT01680016|O4|Outcome|Essen(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169208|NCT01680016|O3|Outcome|Zagreb(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
169209|NCT01680016|O2|Outcome|Essen(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169210|NCT01680016|O1|Outcome|Zagreb(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
169211|NCT01680016|O6|Outcome|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169212|NCT01680016|O5|Outcome|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
169213|NCT01680016|O4|Outcome|Essen(≥61 Years)|≥61 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169214|NCT01680016|O3|Outcome|Zagreb(≥61 Years)|≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
169215|NCT01680016|O2|Outcome|Essen(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169216|NCT01680016|O1|Outcome|Zagreb(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
169217|NCT01680016|O6|Outcome|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169218|NCT01680016|O5|Outcome|Zagreb( ≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
169219|NCT01680016|O4|Outcome|Essen(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169220|NCT01680016|O3|Outcome|Zagreb(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
169221|NCT01680016|O2|Outcome|Essen(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169222|NCT01680016|O1|Outcome|Zagreb(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
169361|NCT01679002|O1|Outcome|BIA 2-093 900 mg od|ESL, Eslicarbazepine acetate BIA 2-093 900 mg od
169223|NCT01680016|O6|Outcome|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169224|NCT01680016|O5|Outcome|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
169225|NCT01680016|O4|Outcome|Essen(≥61 Years)|≥61 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169226|NCT01680016|O3|Outcome|Zagreb(≥61 Years)|≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
169227|NCT01680016|O2|Outcome|Essen(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169228|NCT01680016|O1|Outcome|Zagreb(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
169229|NCT01680016|O6|Outcome|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169230|NCT01680016|O5|Outcome|Zagreb( ≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
169231|NCT01680016|O4|Outcome|Essen(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169232|NCT01680016|O3|Outcome|Zagreb(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
169233|NCT01680016|O2|Outcome|Essen(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169234|NCT01680016|O1|Outcome|Zagreb(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
169235|NCT01680016|O6|Outcome|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169236|NCT01680016|O5|Outcome|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
169237|NCT01680016|O4|Outcome|Essen(≥61 Years)|≥61 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169238|NCT01680016|O3|Outcome|Zagreb(≥61 Years)|≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
169239|NCT01680016|O2|Outcome|Essen(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169240|NCT01680016|O1|Outcome|Zagreb(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
169241|NCT01680016|O6|Outcome|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169242|NCT01680016|O5|Outcome|Zagreb( ≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
169243|NCT01680016|O4|Outcome|Essen(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169244|NCT01680016|O3|Outcome|Zagreb(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
169245|NCT01680016|O2|Outcome|Essen(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169246|NCT01680016|O1|Outcome|Zagreb(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
169247|NCT01680016|O2|Outcome|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169248|NCT01680016|O1|Outcome|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
169249|NCT01680016|O2|Outcome|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
169250|NCT01680016|O1|Outcome|Zagreb(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
169251|NCT01680016|E4|Reported Event|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 doses of Rabipur at days 1, 4, 8, 15 and 29
169252|NCT01680016|E3|Reported Event|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
169253|NCT01680016|E2|Reported Event|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 doses of Rabipur at days 1, 4, 8, 15 and 29
169254|NCT01680016|E1|Reported Event|Zagreb(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
169255|NCT01679613|B1|Baseline|Overall Study|This was a randomised, open-label trial in healthy male subjects with a 2-way cross-over Pilot part, followed by a 2-way cross-over Main part. Subjects participated either in the Pilot part with 2 treatments (A and B) given in 1 of the 2 treatment sequences (A_B and B_A) or in the Main part with also 2 treatments (C and D) given in 1 of the 2 treatment sequences (C_D and D_C). Nintedanib administrations of the 2 respective treatments (A and B or C and D) were to be separated by a wash-out period of at least 14 days. The Pilot part was separated from the Main part by at least 3 weeks to allow for interim analysis
169256|NCT01679613|P4|Participant Flow|Nintedanib+Ketoconazole (Main Part)/ Nintedanib (Main Part)|Ketoconazole 400mg was given once daily for 3 days followed by administration of nintedanib 50mg as a single dose 1h after administration of ketoconazole, based on the results from the Pilot part. Nintedanib administration was done under steady state ketoconazole (Treatment D). Following a wash out period of at least 14 days, nintedanib 50mg was given as a single dose, based on the results from the Pilot part (Treatment C).
169280|NCT01679314|B1|Baseline|Active AlphaCore Device|"AlphaCore active stimulation treatment~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
169281|NCT01679314|P2|Participant Flow|Sham AlphaCore Device|"AlphaCore sham device~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
169257|NCT01679613|P3|Participant Flow|Nintedanib (Main Part)/ Nintedanib+Ketoconazole (Main Part)|Based on the results from the Pilot part, nintedanib 50mg was given as a single dose (Treatment C). Following a wash out period of at least 14 days, ketoconazole 400mg was given once daily for 3 days followed by administration of nintedanib 50mg as a single dose 1h after administration of ketoconazole, based on the results from the Pilot part. Nintedanib administration was done under steady state ketoconazole (Treatment D)
169258|NCT01679613|P2|Participant Flow|Nintedanib+Ketoconazole (Pilot Part)/ Nintedanib (Pilot Part)|Ketoconazole 400mg was given once daily for three days and nintedanib 50 mg was given as a single dose 1 hour (h) after the ketoconazole administration with ketoconazole under steady-state conditions (Treatment B). Following a wash out period of at least 14 days, nintedanib 50mg was given as a single dose (Treatment A).
169259|NCT01679613|P1|Participant Flow|Nintedanib (Pilot Part)/ Nintedanib+Ketoconazole (Pilot Part)|Nintedanib 50mg was given as a single dose (Treatment A). Following a wash out period of at least 14 days, ketoconazole 400mg was given once daily for three days and nintedanib 50 mg was given as a single dose 1 hour (h) after the ketoconazole administration with ketoconazole under steady-state conditions (Treatment B)
169260|NCT01679613|O2|Outcome|Nintedanib + Ketoconazole|"In both parts (Pilot and Main) of the study 400 mg ketoconazole were given once daily for 3 days starting on Day -2 and 50 mg nintedanib were given as a single dose 1 h after the ketoconazole administration on Day 1, with ketoconazole under steady-state conditions.~In the Main part, alternatively, a single dose of 100mg could have been given 1 h after the ketoconazole administration or 4 h before the ketoconazole administration on Day 1. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
169261|NCT01679613|O1|Outcome|Nintedanib|"In both parts (Pilot and Main) 50 mg of nintedanib were given as a single dose on Day 1.~In the Main part, alternatively, a single dose of 100mg could have been given. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
169262|NCT01679613|O2|Outcome|Nintedanib + Ketoconazole|"In both parts (Pilot and Main) of the study 400 mg ketoconazole were given once daily for 3 days starting on Day -2 and 50 mg nintedanib were given as a single dose 1 h after the ketoconazole administration on Day 1, with ketoconazole under steady-state conditions.~In the Main part, alternatively, a single dose of 100mg could have been given 1 h after the ketoconazole administration or 4 h before the ketoconazole administration on Day 1. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
169263|NCT01679613|O1|Outcome|Nintedanib|"In both parts (Pilot and Main) 50 mg of nintedanib were given as a single dose on Day 1.~In the Main part, alternatively, a single dose of 100mg could have been given. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
169264|NCT01679613|O2|Outcome|Nintedanib + Ketoconazole|"In both parts (Pilot and Main) of the study 400 mg ketoconazole were given once daily for 3 days starting on Day -2 and 50 mg nintedanib were given as a single dose 1 h after the ketoconazole administration on Day 1, with ketoconazole under steady-state conditions.~In the Main part, alternatively, a single dose of 100mg could have been given 1 h after the ketoconazole administration or 4 h before the ketoconazole administration on Day 1. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
169265|NCT01679613|O1|Outcome|Nintedanib|"In both parts (Pilot and Main) 50 mg of nintedanib were given as a single dose on Day 1.~In the Main part, alternatively, a single dose of 100mg could have been given. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
169266|NCT01679613|E3|Reported Event|Nintedanib + Ketoconazole|"In both parts (Pilot and Main) of the study 400 mg ketoconazole were given once daily for 3 days starting on Day -2 and 50 mg nintedanib were given as a single dose 1 h after the ketoconazole administration on Day 1, with ketoconazole under steady-state conditions.~In the Main part, alternatively, a single dose of 100mg could have been given 1 h after the ketoconazole administration or 4 h before the ketoconazole administration on Day 1. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
169267|NCT01679613|E2|Reported Event|Nintedanib|"In both parts (Pilot and Main) 50 mg of nintedanib were given as a single dose on Day 1.~In the Main part, alternatively, a single dose of 100mg could have been given. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
169268|NCT01679613|E1|Reported Event|Ketoconazole|In both parts (Pilot and Main) of the study 400 mg ketoconazole were given once daily for 3 days starting on Day -2
169269|NCT01679600|B3|Baseline|Total|Total of all reporting groups
169270|NCT01679600|B2|Baseline|RATE|"Robotics-assisted treadmill exercise~Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise"
169271|NCT01679600|B1|Baseline|FC-RATE|"Feedback-controlled robotics-assisted treadmill exercise~Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate"
169272|NCT01679600|P2|Participant Flow|RATE|"Robotics-assisted treadmill exercise~Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise"
169273|NCT01679600|P1|Participant Flow|FC-RATE|"Feedback-controlled robotics-assisted treadmill exercise~Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate"
169274|NCT01679600|O2|Outcome|RATE|"Robotics-assisted treadmill exercise~Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise"
169275|NCT01679600|O1|Outcome|FC-RATE|"Feedback-controlled robotics-assisted treadmill exercise~Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate"
169276|NCT01679600|E2|Reported Event|RATE|"Robotics-assisted treadmill exercise~Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise"
169277|NCT01679600|E1|Reported Event|FC-RATE|"Feedback-controlled robotics-assisted treadmill exercise~Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate"
169278|NCT01679314|B3|Baseline|Total|Total of all reporting groups
169279|NCT01679314|B2|Baseline|Sham AlphaCore Device|"AlphaCore sham device~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
169282|NCT01679314|P1|Participant Flow|Active AlphaCore Device|"AlphaCore active stimulation treatment~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
169283|NCT01679314|O2|Outcome|Sham AlphaCore Device|Sham AlphaCore Device Each study group will go under the same treatment regimen and assessments.
169284|NCT01679314|O1|Outcome|Active AlphaCore Device|Active AlphaCore Device Each study group will go under the same treatment regimen and assessments.
169285|NCT01679314|O2|Outcome|Sham AlphaCore Device|"Sham AlphaCore Device~Each study group will go under the same treatment regimen and assessments."
169286|NCT01679314|O1|Outcome|Active AlphaCore Device|"Active AlphaCore Device~Each study group will go under the same treatment regimen and assessments."
169287|NCT01679314|O2|Outcome|Sham AlphaCore Device|Sham AlphaCore Device Each study group will go under the same treatment regimen and assessments.
169288|NCT01679314|O1|Outcome|Active AlphaCore Device|Active AlphaCore Device Each study group will go under the same treatment regimen and assessments.
169289|NCT01679314|O2|Outcome|Sham AlphaCore Device|Sham AlphaCore Device Each study group will go under the same treatment regimen and assessments.
169290|NCT01679314|O1|Outcome|Active AlphaCore Device|Active AlphaCore Device Each study group will go under the same treatment regimen and assessments.
169291|NCT01679314|O2|Outcome|Sham AlphaCore Device|Sham AlphaCore Device Each study group will go under the same treatment regimen and assessments.
169292|NCT01679314|O1|Outcome|Active AlphaCore Device|Active AlphaCore Device Each study group will go under the same treatment regimen and assessments.
169293|NCT01679314|O2|Outcome|Sham AlphaCore Device|Sham AlphaCore Device Each study group will go under the same treatment regimen and assessments.
169294|NCT01679314|O1|Outcome|Active AlphaCore Device|Active AlphaCore Device Each study group will go under the same treatment regimen and assessments.
169295|NCT01679314|O2|Outcome|Sham AlphaCore Device|"AlphaCore sham device~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
169296|NCT01679314|O1|Outcome|Active AlphaCore Device|"AlphaCore active stimulation treatment~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
169297|NCT01679314|E2|Reported Event|Sham AlphaCore Device|"AlphaCore sham device~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
169298|NCT01679314|E1|Reported Event|Active AlphaCore Device|"AlphaCore active stimulation treatment~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
169299|NCT01679236|B3|Baseline|Total|Total of all reporting groups
169300|NCT01679236|B2|Baseline|Interactive Learning for Smokers|"Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.~Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long)."
169301|NCT01679236|B1|Baseline|Mindfulness Training for Smokers|"Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.~Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long)."
169302|NCT01679236|P2|Participant Flow|Interactive Learning for Smokers|"Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.~Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long)."
169303|NCT01679236|P1|Participant Flow|Mindfulness Training for Smokers|"Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.~Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long)."
169304|NCT01679236|O2|Outcome|Interactive Learning for Smokers|"Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.~Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long)."
169355|NCT01679002|O1|Outcome|BIA 2-093 900 mg od|ESL, Eslicarbazepine acetate BIA 2-093 900 mg od
169356|NCT01679002|O3|Outcome|Oxcarbazepine 450 mg Bid|OXC, Oxcarbazepine 450 mg bid
169357|NCT01679002|O2|Outcome|BIA 2-093 450 mg Bid|ESL, Eslicarbazepine acetate BIA 2-093 450 mg bid
169358|NCT01679002|O1|Outcome|BIA 2-093 900 mg od|ESL, Eslicarbazepine acetate BIA 2-093 900 mg od
169359|NCT01679002|O3|Outcome|Oxcarbazepine 450 mg Bid|OXC, Oxcarbazepine 450 mg bid
169305|NCT01679236|O1|Outcome|Mindfulness Training for Smokers|"Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.~Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long)."
169306|NCT01679236|E2|Reported Event|Interactive Learning for Smokers|"Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.~Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long)."
169307|NCT01679236|E1|Reported Event|Mindfulness Training for Smokers|"Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.~Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long)."
169308|NCT01679197|B1|Baseline|Treatment|"Metreleptin~Metreleptin"
169309|NCT01679197|P1|Participant Flow|Treatment|"Metreleptin~Metreleptin"
169310|NCT01679197|O1|Outcome|Treatment|"Metreleptin~Metreleptin"
169311|NCT01679197|O1|Outcome|Treatment|"Metreleptin~Metreleptin"
169312|NCT01679197|O4|Outcome|LDL mg/dL|Lipid measurement
169313|NCT01679197|O3|Outcome|HDL Cholesterol mg/dL|Lipid measurement
169314|NCT01679197|O2|Outcome|Triglycerides mg/dL|Lipid measurement
169315|NCT01679197|O1|Outcome|Cholesterol, Total mg/dL|Lipid measurement
169316|NCT01679197|O2|Outcome|Liver Function ALT|
169317|NCT01679197|O1|Outcome|Liver Function AST|
169318|NCT01679197|O1|Outcome|Treatment|"Metreleptin~Metreleptin"
169319|NCT01679197|O1|Outcome|Treatment|"Metreleptin~Metreleptin"
169320|NCT01679197|E1|Reported Event|Treatment|"Metreleptin~Metreleptin"
169321|NCT01679028|B7|Baseline|Total|Total of all reporting groups
169322|NCT01679028|B6|Baseline|T89 Group C|T89 225mg bid for 14 days
169323|NCT01679028|B5|Baseline|Placebo Group C|Placebo 225mg bid for 14 days
169324|NCT01679028|B4|Baseline|T89 Group B|T89 300mg single dose
169325|NCT01679028|B3|Baseline|Placebo Group B|Placebo 300mg single dose
169326|NCT01679028|B2|Baseline|T89 Group A|T89 150mg single dose
169327|NCT01679028|B1|Baseline|Placebo Group A|Placebo 150mg single dose
169328|NCT01679028|P6|Participant Flow|T89 Group C|T89 225mg bid for 14 days
169329|NCT01679028|P5|Participant Flow|Placebo Group C|Placebo 225mg bid for 14 days
169330|NCT01679028|P4|Participant Flow|T89 Group B|T89 300mg single dose
169331|NCT01679028|P3|Participant Flow|Placebo Group B|Placebo 300mg single dose
169332|NCT01679028|P2|Participant Flow|T89 Group A|T89 150mg single dose
169333|NCT01679028|P1|Participant Flow|Placebo Group A|Placebo 150mg single dose
169334|NCT01679028|O6|Outcome|T89 Group C|T89 225mg bid for 10 days
169335|NCT01679028|O5|Outcome|Placebo Group C|225mg bid for 10 days
169336|NCT01679028|O4|Outcome|T89 Group B|300mg T89; single dose
169337|NCT01679028|O3|Outcome|Placebo Group B|300mg Placebo; single dose
169338|NCT01679028|O2|Outcome|T89 Group A|150mg T89; Single dose
169339|NCT01679028|O1|Outcome|Placebo Group A|150 mg placebo; single dose
169340|NCT01679028|E6|Reported Event|T89 Group C|T89 225mf bid for 14 days
169341|NCT01679028|E5|Reported Event|Placebo Group C|Placebo 225mg bid for 14 days
169342|NCT01679028|E4|Reported Event|T89 Group B|300mg T89 single dose
169343|NCT01679028|E3|Reported Event|Placebo Group B|300mg Placebo single dose
169344|NCT01679028|E2|Reported Event|T89 Group A|150mg T89 single dose
169345|NCT01679028|E1|Reported Event|Placebo Group A|150 mg Placebo Single dose
169346|NCT01679002|B4|Baseline|Total|Total of all reporting groups
169347|NCT01679002|B3|Baseline|Group C|oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 450 mg once-daily period followed by BIA 2-093 450 mg twice-daily period OXC 450 mg bid - BIA 2-093 450 mg od - BIA 2-093 450 mg bid
169348|NCT01679002|B2|Baseline|Group B|BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 450 mg once-daily period BIA 2-093 450 mg bid - OXC 450 mg bid - BIA 2-093 450 mg od
169349|NCT01679002|B1|Baseline|Group A|BIA 2-093 450 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period BIA 2-093 450 mg od - BIA 2-093 450 mg bid - OXC 450 mg bid
169350|NCT01679002|P3|Participant Flow|Group C|oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period OXC 450 mg bid - BIA 2-093 900 mg od - BIA 2-093 450 mg bid
169351|NCT01679002|P2|Participant Flow|Group B|"BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period~BIA 2-093 450 mg bid OXC 450 mg bid BIA 2-093 900 mg od"
169352|NCT01679002|P1|Participant Flow|Group A|"BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period.~BIA 2-093 900 mg od - BIA 2-093 450 mg bid - OXC 450 mg bid"
169353|NCT01679002|O3|Outcome|Oxcarbazepine 450 mg Bid|OXC, Oxcarbazepine 450 mg bid
169354|NCT01679002|O2|Outcome|BIA 2-093 450 mg Bid|ESL, Eslicarbazepine acetate BIA 2-093 450 mg bid
169362|NCT01679002|E3|Reported Event|Oxcarbazepine 450 mg Bid|OXC, Oxcarbazepine 450 mg bid
169363|NCT01679002|E2|Reported Event|BIA 2-093 450 mg Bid|ESL, Eslicarbazepine acetate BIA 2-093 450 mg bid
169364|NCT01679002|E1|Reported Event|BIA 2-093 900 mg|ESL, Eslicarbazepine acetate BIA 2-093 900 mg od
169365|NCT01678976|B3|Baseline|Total|Total of all reporting groups
169366|NCT01678976|B2|Baseline|Period 1 - Oxcarbazepine; Period 2 - BIA 2-093|Period 1 - Subjects recieved 900 mg of oxcarbazepine Period 2 - Subjects recieved 900 mg of BIA 2-093
169367|NCT01678976|B1|Baseline|Period 1 - BIA 2-093; Period 2 - Oxcarbazepine|Period 1 - Subjects recieved 900 mg of BIA 2-093 Period 2 - Subjects recieved 900 mg of oxcarbazepine
169368|NCT01678976|P2|Participant Flow|Period 1 - Oxcarbazepine; Period 2 - BIA 2-093|Period 1 - Subjects recieved 900 mg of oxcarbazepine Period 2 - Subjects recieved 900 mg of BIA 2-093
169369|NCT01678976|P1|Participant Flow|Period 1 - BIA 2-093; Period 2 - Oxcarbazepine|Period 1 - Subjects recieved 900 mg of BIA 2-093 Period 2 - Subjects recieved 900 mg of oxcarbazepine
169370|NCT01678976|O2|Outcome|Oxcarbazepine|Oxcarbazepine, Trileptal
169371|NCT01678976|O1|Outcome|BIA 2-093|BIA 2-093, ESL, Eslicarbazepine
169372|NCT01678976|O2|Outcome|Oxcarbazepine 900 mg od|Oxcarbazepine, Trileptal®
169373|NCT01678976|O1|Outcome|BIA 2-093 900 mg od|BIA 2-093, ESL, Eslicarbazepine acetate
169374|NCT01678976|O2|Outcome|Oxcarbazepine 900 mg od|Oxcarbazepine, Trileptal®
169375|NCT01678976|O1|Outcome|BIA 2-093 900 mg od|BIA 2-093, ESL Eslicarbazepine acetate
169376|NCT01678976|E2|Reported Event|Oxcarbazepine|Oxcarbazepine, Trileptal
169377|NCT01678976|E1|Reported Event|BIA 2-093|BIA 2-093, ESL, Eslicarbazepine
169378|NCT01678911|B1|Baseline|All Subjects|All randomized subjects
169379|NCT01678911|P2|Participant Flow|Gralise Then Placebo|"Gralise (a long acting gabapentinoid)~Gralise: Subjects will start at 600mg and titrate up by 600mg a week for two weeks (to 1800mg), then remain on 1800mg steady state dose of medication (or placebo pills) for 2 weeks. If intolerable side effects occur, the dose may be reduced to last tolerable dose at the discretion of the PI. A 2-week down-titration will be used. Subjects will have 1 week of “wash-out” before repeating the above procedure for the other arm of the study (placebo or medication)."
169380|NCT01678911|P1|Participant Flow|Placebo, Then Gralise|Subjects may receive a pill with no medicine.
169381|NCT01678911|O2|Outcome|Gralise Then Placebo|Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
169382|NCT01678911|O1|Outcome|Placebo Then Gralise|Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.
169383|NCT01678911|O2|Outcome|Gralise Then Placebo|Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
169384|NCT01678911|O1|Outcome|Placebo Then Gralise|Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.
169385|NCT01678911|O2|Outcome|Gralise Then Placebo|Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
169386|NCT01678911|O1|Outcome|Placebo Then Gralise|Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.
169387|NCT01678911|O2|Outcome|Gralise Then Placebo|Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
169388|NCT01678911|O1|Outcome|Placebo Then Gralise|Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.
169389|NCT01678911|O2|Outcome|Gralise Then Placebo|Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
169390|NCT01678911|O1|Outcome|Placebo Then Gralise|Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.
169391|NCT01678911|E2|Reported Event|Gralise|"Gralise (a long acting gabapentinoid)~Gralise: Subjects will start at 600mg and titrate up by 600mg a week for two weeks (to 1800mg), then remain on 1800mg steady state dose of medication (or placebo pills) for 2 weeks. If intolerable side effects occur, the dose may be reduced to last tolerable dose at the discretion of the PI. A 2-week down-titration will be used. Subjects will have 1 week of “wash-out” before repeating the above procedure for the other arm of the study (placebo or medication)."
169392|NCT01678911|E1|Reported Event|Sugar Pill|Subjects may receive a pill with no medicine.
169393|NCT01678885|B3|Baseline|Total|Total of all reporting groups
169394|NCT01678885|B2|Baseline|Sub-study 2|During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods. During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer.During the first week of the doubly labeled water period (day 0 to 7),participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.Participants who complete Phase I of the study will receive a partial supplement low-calorie diet (LCD) for 8 weeks. Participants will return to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data will be collected.
169395|NCT01678885|B1|Baseline|Sub-study 1|During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods. During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer.During the first week of the doubly labeled water period (day 0 to 7),participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.Participants who complete Phase I of the study will receive a partial supplement low-calorie diet (LCD) for 8 weeks. Participants will return to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data will be collected.
169477|NCT01678807|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days
169478|NCT01678807|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days
169396|NCT01678885|P5|Participant Flow|Phase 2- Low-Calorie Diet|"Participants from sub-study 1 and 2 had the chance to receive the low-calorie diet based on their eligibility; i.e., BMI level.~Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected."
169397|NCT01678885|P4|Participant Flow|Phase I Sub Study 2 - Sensewear First, Then Digital Photo|Phase 1- sensewear First, Then Digital Photography
169398|NCT01678885|P3|Participant Flow|Phase 1 Sub Study 2 - Dig Photo First, Then Sensewear|Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.
169399|NCT01678885|P2|Participant Flow|Phase 1 Sub-study 1 - IDEEA & Actical First, Then Dig Photo|Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.
169400|NCT01678885|P1|Participant Flow|Phase I Sub-study 1 - Dig Photo First, Then IDEEA & Actical|Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.
169401|NCT01678885|O1|Outcome|All Participants|All study participants were included in these analyses
169402|NCT01678885|O1|Outcome|All Participants|During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods. During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer.During the first week of the doubly labeled water period (day 0 to 7),participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.Participants who complete Phase I of the study will receive a partial supplement low-calorie diet (LCD) for 8 weeks. Participants will return to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data will be collected.
169403|NCT01678885|O1|Outcome|Phase II|Participants who complete Phase I of the study received a partial supplement low-calorie diet (LCD) for 8 weeks. This diet plan was a 1000-1150 kcal/day diet composed of Health One shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data was collected.
169404|NCT01678885|O1|Outcome|Phase 1|During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods (RFPM). During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer. Participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.
169405|NCT01678885|E2|Reported Event|Sub-study 2|Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.
169406|NCT01678885|E1|Reported Event|Sub-study 1|Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.
169407|NCT01678846|B3|Baseline|Total|Total of all reporting groups
169408|NCT01678846|B2|Baseline|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
169437|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169479|NCT01678807|O3|Outcome|Placebo|Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
169480|NCT01678807|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days
169409|NCT01678846|B1|Baseline|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.~Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
169410|NCT01678846|P2|Participant Flow|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
169411|NCT01678846|P1|Participant Flow|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.~Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
169412|NCT01678846|O2|Outcome|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
169413|NCT01678846|O1|Outcome|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.~Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
169414|NCT01678846|O2|Outcome|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
169415|NCT01678846|O1|Outcome|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.~Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
169416|NCT01678846|O2|Outcome|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
169417|NCT01678846|O1|Outcome|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.~Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
169418|NCT01678846|O2|Outcome|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
169419|NCT01678846|O1|Outcome|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.~Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
169420|NCT01678846|E2|Reported Event|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
169438|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
183863|NCT01627002|O9|Outcome|Part B Placebo|
169421|NCT01678846|E1|Reported Event|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.~Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
169422|NCT01678820|B4|Baseline|Total|Total of all reporting groups
169423|NCT01678820|B3|Baseline|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169424|NCT01678820|B2|Baseline|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169425|NCT01678820|B1|Baseline|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169426|NCT01678820|P3|Participant Flow|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169427|NCT01678820|P2|Participant Flow|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169428|NCT01678820|P1|Participant Flow|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169429|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169430|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169431|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169432|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169433|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169434|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169435|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169436|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
183864|NCT01627002|O8|Outcome|Part B PA401 3.0 mg|
169439|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169440|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169441|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169442|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169443|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169444|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169445|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169446|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169447|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169448|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169449|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169450|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169451|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169452|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169453|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169454|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169476|NCT01678807|O3|Outcome|Placebo|Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
171362|NCT01672242|O1|Outcome|HFNC|High flow nasal cannula oxygen 40 liters/min
169455|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169456|NCT01678820|O2|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169457|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169458|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169459|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169460|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169461|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169462|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169463|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169464|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169465|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169466|NCT01678820|E3|Reported Event|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169467|NCT01678820|E2|Reported Event|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169468|NCT01678820|E1|Reported Event|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
169469|NCT01678807|B4|Baseline|Total|Total of all reporting groups
169470|NCT01678807|B3|Baseline|Placebo|Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
169471|NCT01678807|B2|Baseline|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days
169472|NCT01678807|B1|Baseline|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days
169473|NCT01678807|P3|Participant Flow|Placebo|Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
169474|NCT01678807|P2|Participant Flow|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days
169475|NCT01678807|P1|Participant Flow|MK-8237 12 Development Units (DU)|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days
169481|NCT01678807|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days
169482|NCT01678807|E3|Reported Event|Placebo|Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
169483|NCT01678807|E2|Reported Event|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days
169484|NCT01678807|E1|Reported Event|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days
169485|NCT01678443|B1|Baseline|Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)|"Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.~indium In 111 anti-CD45 monoclonal antibody BC8: Given IV~yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV~peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant"
169486|NCT01678443|P1|Participant Flow|Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)|"Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.~indium In 111 anti-CD45 monoclonal antibody BC8: Given IV~yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV~peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant"
169487|NCT01678443|O1|Outcome|Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)|"Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.~indium In 111 anti-CD45 monoclonal antibody BC8: Given IV~yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV~peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant"
169488|NCT01678443|O1|Outcome|Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)|"Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.~indium In 111 anti-CD45 monoclonal antibody BC8: Given IV~yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV~peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant"
169489|NCT01678443|E1|Reported Event|Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)|"Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.~indium In 111 anti-CD45 monoclonal antibody BC8: Given IV~yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV~peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant"
169490|NCT01678313|B3|Baseline|Total|Total of all reporting groups
169491|NCT01678313|B2|Baseline|Control Group|Doxazosin 4 mg alone everyday, complete 3 month therapy N=58(82.9%)
169492|NCT01678313|B1|Baseline|Study Group|Doxazosin 4 mg daily plus celecoxib 200 mg daily, complete 3 month therapy N=64(91.4%)
169493|NCT01678313|P2|Participant Flow|Control Group|Doxazosin 4 mg every day (QD)
169494|NCT01678313|P1|Participant Flow|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
169495|NCT01678313|O2|Outcome|Control Group|Doxazosin 4 mg every day (QD)
169496|NCT01678313|O1|Outcome|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
169497|NCT01678313|O2|Outcome|Control Group|Doxazosin 4 mg every day (QD)
169498|NCT01678313|O1|Outcome|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
169499|NCT01678313|O2|Outcome|Control Group|Doxazosin 4 mg every day (QD)
169500|NCT01678313|O1|Outcome|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
169501|NCT01678313|O2|Outcome|Control Group|Doxazosin 4 mg every day (QD)
169502|NCT01678313|O1|Outcome|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
169503|NCT01678313|O2|Outcome|Control Group|Doxazosin 4 mg every day (QD)
169504|NCT01678313|O1|Outcome|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
169505|NCT01678313|O2|Outcome|Control Group|Doxazosin 4 mg every day (QD)
169506|NCT01678313|O1|Outcome|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
169507|NCT01678313|E2|Reported Event|Control Group|Doxazosin 4 mg every day (QD)
169508|NCT01678313|E1|Reported Event|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
169509|NCT01678196|B3|Baseline|Total|Total of all reporting groups
169510|NCT01678196|B2|Baseline|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention~Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
169511|NCT01678196|B1|Baseline|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period~VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
169512|NCT01678196|P2|Participant Flow|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention~Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
169513|NCT01678196|P1|Participant Flow|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period~VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
169514|NCT01678196|O2|Outcome|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention~Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
169730|NCT01677286|O1|Outcome|Amyloid Nephropathy: Proteinuria (g/Day)|Patients with predominant amyloid kidney involvement at enrollment.
169515|NCT01678196|O1|Outcome|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period~VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
169516|NCT01678196|O2|Outcome|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention~Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
169517|NCT01678196|O1|Outcome|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period~VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
169518|NCT01678196|O2|Outcome|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention~Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
169519|NCT01678196|O1|Outcome|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period~VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
169520|NCT01678196|O2|Outcome|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention~Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
169521|NCT01678196|O1|Outcome|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period~VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
169522|NCT01678196|E2|Reported Event|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention~Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
169523|NCT01678196|E1|Reported Event|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period~VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
169524|NCT01678131|B4|Baseline|Total|Total of all reporting groups
169525|NCT01678131|B3|Baseline|600 mg Vaniprevir + PegIFN/RBV|Participants received 600 mg vaniprevir from Days 1-7; Peg-IFN once weekly, RBV twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
169526|NCT01678131|B2|Baseline|300 mg Vaniprevir + PegIFN/RBV|Participants received 300 mg vaniprevir from Days 1-7; Pegylated Interferon (Peg-IFN) alpha-2b once weekly, Ribavirin (RBV) twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
169527|NCT01678131|B1|Baseline|600 mg Vaniprevir|Participants received 600 mg vaniprevir only from Days 1-7; and had postdose liver biopsy from Day 7 up to Day 10 done by Fine Needle Aspiration (FNA) and Core Needle Biopsy (CNB).
169528|NCT01678131|P3|Participant Flow|600 mg Vaniprevir + PegIFN/RBV|Participants received 600 mg vaniprevir from Days 1-7; Peg-IFN once weekly, RBV twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
169529|NCT01678131|P2|Participant Flow|300 mg Vaniprevir + PegIFN/RBV|Participants received 300 mg vaniprevir from Days 1-7; Pegylated Interferon (Peg-IFN) alpha-2b once weekly, Ribavirin (RBV) twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
169530|NCT01678131|P1|Participant Flow|600 mg Vaniprevir|Participants received 600 mg vaniprevir only from Days 1-7; and had postdose liver biopsy from Day 7 up to Day 10 done by Fine Needle Aspiration (FNA) and Core Needle Biopsy (CNB).
169531|NCT01678131|O3|Outcome|600 mg Vaniprevir + PegIFN/RBV|Participants received 600 mg vaniprevir from Days 1-7; Peg-IFN once weekly, RBV twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
169532|NCT01678131|O2|Outcome|300 mg Vaniprevir + PegIFN/RBV|Participants received 300 mg vaniprevir from Days 1-7; Pegylated Interferon (Peg-IFN) alpha-2b once weekly, Ribavirin (RBV) twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
169533|NCT01678131|O1|Outcome|600 mg Vaniprevir|Participants received 600 mg vaniprevir only from Days 1-7; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
169534|NCT01678131|E3|Reported Event|600 mg Vaniprevir + PegIFN/RBV|Participants received 600 mg vaniprevir from Days 1-7; Peg-IFN once weekly, RBV twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
169535|NCT01678131|E2|Reported Event|300 mg Vaniprevir + PegIFN/RBV|Participants received 300 mg vaniprevir from Days 1-7; Pegylated Interferon (Peg-IFN) alpha-2b once weekly, Ribavirin (RBV) twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
169536|NCT01678131|E1|Reported Event|600 mg Vaniprevir|Participants received 600 mg vaniprevir only from Days 1-7; and had postdose liver biopsy from Day 7 up to Day 10 done by Fine Needle Aspiration (FNA) and Core Needle Biopsy (CNB).
169537|NCT01677988|B1|Baseline|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
169538|NCT01677988|P1|Participant Flow|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
169539|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
169598|NCT01677858|O3|Outcome|Carfilzomib 88 mg/m²|Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
169540|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
169541|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
169542|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
169543|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
169544|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
169545|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
169546|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for -08 weeks, then surgical resection
169547|NCT01677988|E1|Reported Event|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
169548|NCT01677936|B3|Baseline|Total|Total of all reporting groups
169549|NCT01677936|B2|Baseline|Snack Group|"Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.~Snacks: 100 calorie snack packs will be administered to the subjects in the snack group"
169550|NCT01677936|B1|Baseline|Raisin|"Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.~Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm"
169551|NCT01677936|P2|Participant Flow|Snack Group|"Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.~Snacks: 100 calorie snack packs will be administered to the subjects in the snack group"
169552|NCT01677936|P1|Participant Flow|Raisin|"Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.~Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm"
169553|NCT01677936|O2|Outcome|Snack Group|"Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.~Snacks: 100 calorie snack packs will be administered to the subjects in the snack group"
169554|NCT01677936|O1|Outcome|Raisin|"Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.~Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm"
169555|NCT01677936|O2|Outcome|Snack Group|"Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.~Snacks: 100 calorie snack packs will be administered to the subjects in the snack group"
169556|NCT01677936|O1|Outcome|Raisin|"Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.~Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm"
169557|NCT01677936|E2|Reported Event|Snacks|Snack group
169558|NCT01677936|E1|Reported Event|Raisin|Raisin group
169559|NCT01677910|B4|Baseline|Total|Total of all reporting groups
169560|NCT01677910|B3|Baseline|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive, one telotristat etiprate 250 mg plus one placebo-matching telotristat etiprate tablet administered 3 times daily for 1 week, followed by two telotristat etiprate (250 mg) tablets administered three times daily for 11 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
169561|NCT01677910|B2|Baseline|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period on stable-dose somatostatin analog (SSA) therapy (octreotide or lanreotide) participants were randomized to receive one 250 mg telotristat etiprate tablet plus one placebo-matching telotristat etiprate tablet administered three times daily for 12 Weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
169562|NCT01677910|B1|Baseline|Placebo|Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
169563|NCT01677910|P4|Participant Flow|Telotristat Etiprate Open-Label Extension|Patients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks.
169731|NCT01677286|O1|Outcome|Amyloid Nephropathy|Patients with predominant amyloid kidney involvement at enrollment.
169564|NCT01677910|P3|Participant Flow|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive, one telotristat etiprate 250 mg plus one placebo-matching telotristat etiprate tablet administered 3 times daily for 1 week, followed by two telotristat etiprate (250 mg) tablets administered three times daily for 11 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
169565|NCT01677910|P2|Participant Flow|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period on stable-dose somatostatin analog (SSA) therapy (octreotide or lanreotide) participants were randomized to receive one 250 mg telotristat etiprate tablet plus one placebo-matching telotristat etiprate tablet administered three times daily for 12 Weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
169566|NCT01677910|P1|Participant Flow|Placebo|Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
169567|NCT01677910|O1|Outcome|Telotristat Etiprate Open-Label Extension|Patients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks.
169568|NCT01677910|O3|Outcome|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive, one telotristat etiprate 250 mg plus one placebo-matching telotristat etiprate tablet administered 3 times daily for 1 week, followed by two telotristat etiprate (250 mg) tablets administered three times daily for 11 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
169569|NCT01677910|O2|Outcome|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period on stable-dose somatostatin analog (SSA) therapy (octreotide or lanreotide) participants were randomized to receive one 250 mg telotristat etiprate tablet plus one placebo-matching telotristat etiprate tablet administered three times daily for 12 Weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
169570|NCT01677910|O1|Outcome|Placebo|Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
169571|NCT01677910|O3|Outcome|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive, one telotristat etiprate 250 mg plus one placebo-matching telotristat etiprate tablet administered 3 times daily for 1 week, followed by two telotristat etiprate (250 mg) tablets administered three times daily for 11 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
169572|NCT01677910|O2|Outcome|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period on stable-dose somatostatin analog (SSA) therapy (octreotide or lanreotide) participants were randomized to receive one 250 mg telotristat etiprate tablet plus one placebo-matching telotristat etiprate tablet administered three times daily for 12 Weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
169573|NCT01677910|O1|Outcome|Placebo|Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
169574|NCT01677910|O3|Outcome|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive, one telotristat etiprate 250 mg plus one placebo-matching telotristat etiprate tablet administered 3 times daily for 1 week, followed by two telotristat etiprate (250 mg) tablets administered three times daily for 11 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
169575|NCT01677910|O2|Outcome|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period on stable-dose somatostatin analog (SSA) therapy (octreotide or lanreotide) participants were randomized to receive one 250 mg telotristat etiprate tablet plus one placebo-matching telotristat etiprate tablet administered three times daily for 12 Weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
169576|NCT01677910|O1|Outcome|Placebo|Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
169577|NCT01677910|O3|Outcome|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive, one telotristat etiprate 250 mg plus one placebo-matching telotristat etiprate tablet administered 3 times daily for 1 week, followed by two telotristat etiprate (250 mg) tablets administered three times daily for 11 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
169578|NCT01677910|O2|Outcome|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period on stable-dose somatostatin analog (SSA) therapy (octreotide or lanreotide) participants were randomized to receive one 250 mg telotristat etiprate tablet plus one placebo-matching telotristat etiprate tablet administered three times daily for 12 Weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
169579|NCT01677910|O1|Outcome|Placebo|Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
169580|NCT01677910|O3|Outcome|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive, one telotristat etiprate 250 mg plus one placebo-matching telotristat etiprate tablet administered 3 times daily for 1 week, followed by two telotristat etiprate (250 mg) tablets administered three times daily for 11 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
183865|NCT01627002|O7|Outcome|Part B PA401 1.0 mg|
169581|NCT01677910|O2|Outcome|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period on stable-dose somatostatin analog (SSA) therapy (octreotide or lanreotide) participants were randomized to receive one 250 mg telotristat etiprate tablet plus one placebo-matching telotristat etiprate tablet administered three times daily for 12 Weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
169582|NCT01677910|O1|Outcome|Placebo|Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
169583|NCT01677910|E4|Reported Event|Telotristat Etiprate Open-Label Extension|Patients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks.
169584|NCT01677910|E3|Reported Event|500 mg Telotristat Etiprate|Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive, one 250 mg telotristat etiprate tablet plus one placebo-matching telotristat etiprate tablet administered 3 times daily for 1 week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the double-blind treatment period.
169585|NCT01677910|E2|Reported Event|250 mg Telotristat Etiprate|Following a 3 to 4-week run-in period on stable-dose somatostatin analog (SSA) therapy (octreotide or lanreotide) participants were randomized to receive one 250 mg telotristat etiprate tablet plus one placebo-matching telotristat etiprate tablet administered three times daily for 12 Weeks in the double-blind treatment period.
169586|NCT01677910|E1|Reported Event|Placebo|Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks in the double-blind treatment period.
169587|NCT01677858|B6|Baseline|Total|Total of all reporting groups
169588|NCT01677858|B5|Baseline|Phase 2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169589|NCT01677858|B4|Baseline|Phase 1: Carfilzomib 88 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169590|NCT01677858|B3|Baseline|Phase 1: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169591|NCT01677858|B2|Baseline|Phase 1: Carfilzomib 56 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169592|NCT01677858|B1|Baseline|Phase 1: Carfilzomib 45 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169593|NCT01677858|P5|Participant Flow|Phase 2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169594|NCT01677858|P4|Participant Flow|Phase 1: Carfilzomib 88 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169595|NCT01677858|P3|Participant Flow|Phase 1: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169596|NCT01677858|P2|Participant Flow|Phase 1: Carfilzomib 56 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169597|NCT01677858|P1|Participant Flow|Phase 1: Carfilzomib 45 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169732|NCT01677286|O1|Outcome|Cardiomyopathy|Patients with predominant amyloid involvement of the heart.
169599|NCT01677858|O2|Outcome|Carfilzomib 70 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
169600|NCT01677858|O1|Outcome|Carfilzomib 20 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
169601|NCT01677858|O3|Outcome|Carfilzomib 88 mg/m²|Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
169602|NCT01677858|O2|Outcome|Carfilzomib 70 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
169603|NCT01677858|O1|Outcome|Carfilzomib 20 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
169604|NCT01677858|O3|Outcome|Carfilzomib 88 mg/m²|Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
169605|NCT01677858|O2|Outcome|Carfilzomib 70 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
169606|NCT01677858|O1|Outcome|Carfilzomib 20 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
169607|NCT01677858|O3|Outcome|Carfilzomib 88 mg/m²|Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
169608|NCT01677858|O2|Outcome|Carfilzomib 70 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
169609|NCT01677858|O1|Outcome|Carfilzomib 20 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
169610|NCT01677858|O3|Outcome|Carfilzomib 88 mg/m²|Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
169611|NCT01677858|O2|Outcome|Carfilzomib 70 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
169612|NCT01677858|O1|Outcome|Carfilzomib 20 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
169613|NCT01677858|O3|Outcome|Carfilzomib 88 mg/m²|Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
169614|NCT01677858|O2|Outcome|Carfilzomib 70 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
169615|NCT01677858|O1|Outcome|Carfilzomib 20 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
169616|NCT01677858|O3|Outcome|Carfilzomib 88 mg/m²|Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
169617|NCT01677858|O2|Outcome|Carfilzomib 70 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
169618|NCT01677858|O1|Outcome|Carfilzomib 20 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
169619|NCT01677858|O3|Outcome|Carfilzomib 88 mg/m²|Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
169620|NCT01677858|O2|Outcome|Carfilzomib 70 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
169621|NCT01677858|O1|Outcome|Carfilzomib 20 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
169622|NCT01677858|O3|Outcome|Carfilzomib 88 mg/m²|Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
169623|NCT01677858|O2|Outcome|Carfilzomib 70 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
169624|NCT01677858|O1|Outcome|Carfilzomib 20 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
169625|NCT01677858|O5|Outcome|Phase 2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169626|NCT01677858|O4|Outcome|Phase 1: Carfilzomib 88 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169627|NCT01677858|O3|Outcome|Phase 1: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169628|NCT01677858|O2|Outcome|Phase 1: Carfilzomib 56 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169629|NCT01677858|O1|Outcome|Phase 1: Carfilzomib 45 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169733|NCT01677286|O1|Outcome|Cardiomyopathy|Patients with predominant amyloid involvement of the heart.
169630|NCT01677858|O6|Outcome|Phase 1+2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169631|NCT01677858|O5|Outcome|Phase 2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169632|NCT01677858|O4|Outcome|Phase 1: Carfilzomib 88 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169633|NCT01677858|O3|Outcome|Phase 1: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169634|NCT01677858|O2|Outcome|Phase 1: Carfilzomib 56 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169635|NCT01677858|O1|Outcome|Phase 1: Carfilzomib 45 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169636|NCT01677858|O6|Outcome|Phase 1+2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169637|NCT01677858|O5|Outcome|Phase 2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169638|NCT01677858|O4|Outcome|Phase 1: Carfilzomib 88 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169639|NCT01677858|O3|Outcome|Phase 1: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169640|NCT01677858|O2|Outcome|Phase 1: Carfilzomib 56 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169641|NCT01677858|O1|Outcome|Phase 1: Carfilzomib 45 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169642|NCT01677858|O6|Outcome|Phase 1+2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169643|NCT01677858|O5|Outcome|Phase 2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169644|NCT01677858|O4|Outcome|Phase 1: Carfilzomib 88 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169683|NCT01677624|B1|Baseline|Device E7040|An optimal dose and size (100 to 300 μm, 300 to 500 μm, 500 to 700 μm) of microsphere that best matches the pathology (i.e., vascular target, vessel size, and target lesion) and the extent of embolization were carefully selected.
183866|NCT01627002|O6|Outcome|Part A Placebo|
169645|NCT01677858|O3|Outcome|Phase 1: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169646|NCT01677858|O2|Outcome|Phase 1: Carfilzomib 56 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169647|NCT01677858|O1|Outcome|Phase 1: Carfilzomib 45 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169648|NCT01677858|O6|Outcome|Phase 1+2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169649|NCT01677858|O5|Outcome|Phase 2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169650|NCT01677858|O4|Outcome|Phase 1: Carfilzomib 88 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169651|NCT01677858|O3|Outcome|Phase 1: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169652|NCT01677858|O2|Outcome|Phase 1: Carfilzomib 56 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169653|NCT01677858|O1|Outcome|Phase 1: Carfilzomib 45 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169654|NCT01677858|O6|Outcome|Phase 1+2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169655|NCT01677858|O5|Outcome|Phase 2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169656|NCT01677858|O4|Outcome|Phase 1: Carfilzomib 88 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169657|NCT01677858|O3|Outcome|Phase 1: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169658|NCT01677858|O2|Outcome|Phase 1: Carfilzomib 56 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169659|NCT01677858|O1|Outcome|Phase 1: Carfilzomib 45 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169684|NCT01677624|P1|Participant Flow|Device E7040|An optimal dose and size (100 to 300 μm, 300 to 500 μm, 500 to 700 μm) of microsphere that best matches the pathology (i.e., vascular target, vessel size, and target lesion) and the extent of embolization were carefully selected.
183867|NCT01627002|O5|Outcome|Part A PA401 10 mg|
169660|NCT01677858|O4|Outcome|Phase 1: Carfilzomib 88 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169661|NCT01677858|O3|Outcome|Phase 1: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169662|NCT01677858|O2|Outcome|Phase 1: Carfilzomib 56 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169663|NCT01677858|O1|Outcome|Phase 1 Carfilzomib 45 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169664|NCT01677858|E5|Reported Event|Phase 2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169665|NCT01677858|E4|Reported Event|Phase 1: Carfilzomib 88 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169666|NCT01677858|E3|Reported Event|Phase 1: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169667|NCT01677858|E2|Reported Event|Phase 1: Carfilzomib 56 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169668|NCT01677858|E1|Reported Event|Phase 1: Carfilzomib 45 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
169669|NCT01677767|B1|Baseline|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
169670|NCT01677767|P1|Participant Flow|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
169671|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia who had been on other ESAs and had Hb greater than or equal to (≥)10 g/dL at baseline.
169672|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
169673|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
169674|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
169675|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
169676|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
169677|NCT01677767|O1|Outcome|C.E.R.A.|Participants with Hb less than (<) 10 g/dL at enrollment were evaluated for correction of anemia.
169678|NCT01677767|O1|Outcome|C.E.R.A.|Participants with Hb less than (<) 10 g/dL at enrollment were evaluated for correction of anemia.
169679|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
169680|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
169681|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
169682|NCT01677767|E1|Reported Event|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
169685|NCT01677624|O1|Outcome|Device E7040|An optimal dose and size (100 to 300 μm, 300 to 500 μm, 500 to 700 μm) of microsphere that best matches the pathology (i.e., vascular target, vessel size, and target lesion) and the extent of embolization were carefully selected.
169686|NCT01677624|O1|Outcome|Device E7040|An optimal dose and size (100 to 300 μm, 300 to 500 μm, 500 to 700 μm) of microsphere that best matches the pathology (i.e., vascular target, vessel size, and target lesion) and the extent of embolization were carefully selected.
169687|NCT01677624|E1|Reported Event|Device E7040|An optimal dose and size (100 to 300 μm, 300 to 500 μm, 500 to 700 μm) of microsphere that best matches the pathology (i.e., vascular target, vessel size, and target lesion) and the extent of embolization were carefully selected.
169688|NCT01677507|B1|Baseline|Baseline of Entire Population|Both arms are included because the study design was a cross over intent to treat with glaucoma medications. All participants were treated with both medications.
169689|NCT01677507|P2|Participant Flow|Latanoprost Followed by Timolol|"To compare the variation in response to latanoprost between individuals~Variation in eye pressure response to timolol and latanoprost treatment:~Arm 1 initial period is to test for variation in eye pressure response to latanoprost 0.005%, then washout.~Period 2 is to test for variation in eye pressure response to timolol 0.5%."
169690|NCT01677507|P1|Participant Flow|Timolol Followed by Latanoprost|"To compare the variation in response to timolol between individuals~Variation in eye pressure response to timolol and latanoprost treatment: Arm 1 initial period is to test for variation in eye pressure response to timolol 0.5%, then washout.~Period 2 is to test for variation in eye pressure response to latanoprost 0.005%."
169691|NCT01677507|O2|Outcome|Latanoprost|To characterize the response to latanoprost in all participants.
169692|NCT01677507|O1|Outcome|Timolol|To characterize the response to timolol in all participants.
169693|NCT01677507|O2|Outcome|Latanoprost|All participants while on latanoprost and during a post-latanoprost washout
169694|NCT01677507|O1|Outcome|Timolol|All participants while on timolol and during a post-timolol washout
169695|NCT01677507|O2|Outcome|Latanoprost|To characterize the response to latanoprost in all participants.
169696|NCT01677507|O1|Outcome|Timolol|To characterize the response to timolol in all participants.
169697|NCT01677507|E2|Reported Event|Latanoprost|All participants while on latanoprost and during a post-latanoprost washout
169698|NCT01677507|E1|Reported Event|Timolol|All participants while on timolol and during a post-timolol washout
169699|NCT01677299|B5|Baseline|Total|Total of all reporting groups
169700|NCT01677299|B4|Baseline|Sequence DACB|A = 1000 mg EFB0026 BID B = 1000 mg EFB0027 BID C = 500 mg EFB0027 BID D = 500 mg EFB0026 BID plus 1000 mg EFB0027 BID
169701|NCT01677299|B3|Baseline|Sequence CDBA|A = 1000 mg EFB0026 BID B = 1000 mg EFB0027 BID C = 500 mg EFB0027 BID D = 500 mg EFB0026 BID plus 1000 mg EFB0027 BID
169702|NCT01677299|B2|Baseline|Sequence ABDC|A = 1000 mg EFB0026 BID B = 1000 mg EFB0027 BID C = 500 mg EFB0027 BID D = 500 mg EFB0026 BID plus 1000 mg EFB0027 BID
169703|NCT01677299|B1|Baseline|Sequence BCAD|A = 1000 mg EFB0026 BID B = 1000 mg EFB0027 BID C = 500 mg EFB0027 BID D = 500 mg EFB0026 BID plus 1000 mg EFB0027 BID
169704|NCT01677299|P4|Participant Flow|Sequence 4: DACB|"BID~Treatment A = 1000 mg EFB0026 (Met IR) Treatment B = 1000 mg EFB0027 (Met DR) Treatment C = 500 mg EFB0027 (Met DR) Treatment D = 500 mg EFB0026 (Met IR) plus 1000 mg EFB0027 (Met DR)"
169705|NCT01677299|P3|Participant Flow|Sequence 3: CDBA|"BID~Treatment A = 1000 mg EFB0026 (Met IR) Treatment B = 1000 mg EFB0027 (Met DR) Treatment C = 500 mg EFB0027 (Met DR) Treatment D = 500 mg EFB0026 (Met IR) plus 1000 mg EFB0027 (Met DR)"
169706|NCT01677299|P2|Participant Flow|Sequence 2: ABDC|"BID~Treatment A = 1000 mg EFB0026 (Met IR) Treatment B = 1000 mg EFB0027 (Met DR) Treatment C = 500 mg EFB0027 (Met DR) Treatment D = 500 mg EFB0026 (Met IR) plus 1000 mg EFB0027 (Met DR)"
169707|NCT01677299|P1|Participant Flow|Sequence 1: BCAD|"BID~Treatment A = 1000 mg EFB0026 (Met IR) Treatment B = 1000 mg EFB0027 (Met DR) Treatment C = 500 mg EFB0027 (Met DR) Treatment D = 500 mg EFB0026 (Met IR) plus 1000 mg EFB0027 (Met DR)"
169708|NCT01677299|O4|Outcome|500 mg EFB0026 + 1000 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK~EFB0026: Active comparator"
169709|NCT01677299|O3|Outcome|500 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK"
169710|NCT01677299|O2|Outcome|1000 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK"
169711|NCT01677299|O1|Outcome|1000 mg EFB0026|"BID~EFB0026: Active comparator"
169712|NCT01677299|O4|Outcome|500 mg EFB0026 + 1000 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK~EFB0026: Active comparator"
169713|NCT01677299|O3|Outcome|500 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK"
169714|NCT01677299|O2|Outcome|1000 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK"
169715|NCT01677299|O1|Outcome|1000 mg EFB0026|"BID~EFB0026: Active comparator"
169716|NCT01677299|O4|Outcome|500 mg EFB0026 + 1000 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK~EFB0026: Active comparator"
169717|NCT01677299|O3|Outcome|500 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK"
169718|NCT01677299|O2|Outcome|1000 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK"
169719|NCT01677299|O1|Outcome|1000 mg EFB0026|"BID~EFB0026: Active comparator"
169720|NCT01677299|O4|Outcome|500 mg EFB0026 + 1000 mg EFB0027|BID
169721|NCT01677299|O3|Outcome|500 mg EFB0027|BID
169722|NCT01677299|O2|Outcome|1000 mg EFB0027|BID
169723|NCT01677299|O1|Outcome|1000 mg EFB0026|BID
169724|NCT01677299|E4|Reported Event|500 mg EFB0026 BID Plus 1000 mg EFB0027 BID|D: Metformin immediate plus Metformin delayed release
169725|NCT01677299|E3|Reported Event|500 mg EFB0027 BID|C: Metformin delayed release BID
169726|NCT01677299|E2|Reported Event|1000 mg EFB0027 BID|B: Metformin delayed release BID
169727|NCT01677299|E1|Reported Event|1000 mg EFB0026 BID|A: Metformin immediate release BID
169728|NCT01677286|B1|Baseline|Doxycycline 100 mg po Bid x 12 Months|Open-label doxycycline 100 mg twice daily by mouth will be administered to subjects for 12 months.
169729|NCT01677286|P1|Participant Flow|Doxycycline 100 mg po Bid x 12 Months|Open-label doxycycline 100 mg twice daily by mouth will be administered to subjects for 12 months.
169734|NCT01677286|E1|Reported Event|Doxycycline 100 mg po Bid x 12 Months|Open-label doxycycline 100 mg twice daily by mouth was administered to subjects for 12 months, if tolerated.
169735|NCT01677195|B4|Baseline|Total|Total of all reporting groups
169736|NCT01677195|B3|Baseline|Placebo|"Participants will receive placebo capsules shown not to absorb mycotoxins three times a day with meals.~Placebo: Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article."
169737|NCT01677195|B2|Baseline|ACCS100 Low Dose|"Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
169738|NCT01677195|B1|Baseline|ACCS100 High Dose|"Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
169739|NCT01677195|P3|Participant Flow|Placebo|"Participants will receive placebo capsules shown not to absorb mycotoxins three times a day with meals.~Placebo: Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article."
169740|NCT01677195|P2|Participant Flow|ACCS100 Low Dose|"Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
169741|NCT01677195|P1|Participant Flow|ACCS100 High Dose|"Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
169742|NCT01677195|O3|Outcome|Placebo|"Participants will receive placebo capsules shown not to absorb mycotoxins three times a day with meals.~Placebo: Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article."
169743|NCT01677195|O2|Outcome|ACCS100 Low Dose|"Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
169744|NCT01677195|O1|Outcome|ACCS100 High Dose|"Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
169745|NCT01677195|E3|Reported Event|Placebo|"Participants will receive placebo capsules shown not to absorb mycotoxins three times a day with meals.~Placebo: Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article."
169746|NCT01677195|E2|Reported Event|ACCS100 Low Dose|"Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
169747|NCT01677195|E1|Reported Event|ACCS100 High Dose|"Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
169748|NCT01677182|B4|Baseline|Total|Total of all reporting groups
169749|NCT01677182|B3|Baseline|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
169750|NCT01677182|B2|Baseline|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
169751|NCT01677182|B1|Baseline|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
169752|NCT01677182|P3|Participant Flow|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
169753|NCT01677182|P2|Participant Flow|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
169754|NCT01677182|P1|Participant Flow|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
169755|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
169756|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
169757|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
169758|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
169759|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
169760|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
169761|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
169762|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
169763|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
169764|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
169765|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
169766|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
169767|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
169768|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
169769|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
169770|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
169771|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
169772|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
169773|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
169774|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
169775|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
169776|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
169777|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
169778|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
169779|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
169780|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
169781|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
169782|NCT01677182|E3|Reported Event|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
169783|NCT01677182|E2|Reported Event|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
169784|NCT01677182|E1|Reported Event|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
169785|NCT01676961|B1|Baseline|Supportive Care (Romiplostim)|"Patients receive romiplostim SC once weekly for up to 6 weeks. Patients achieving a platelet count > 50 x 10^9 then receive romiplostim once weekly during 1 course of chemotherapy and may continue for as long as benefit is seen..~romiplostim: Given SC"
169786|NCT01676961|P1|Participant Flow|Supportive Care (Romiplostim)|"Patients receive romiplostim SC once weekly for up to 6 weeks. Patients achieving a platelet count > 50 x 10^9 then receive romiplostim once weekly during 1 course of chemotherapy and may continue for as long as benefit is seen..~romiplostim: Given SC"
169787|NCT01676961|O1|Outcome|Supportive Care (Romiplostim)|"Patients receive romiplostim SC once weekly for up to 6 weeks. Patients achieving a platelet count > 50 x 10^9 then receive romiplostim once weekly during 1 course of chemotherapy and may continue for as long as benefit is seen..~romiplostim: Given SC"
169788|NCT01676961|O1|Outcome|Supportive Care (Romiplostim)|"Patients receive romiplostim SC once weekly for up to 6 weeks. Patients achieving a platelet count > 50 x 10^9 then receive romiplostim once weekly during 1 course of chemotherapy and may continue for as long as benefit is seen..~romiplostim: Given SC"
169789|NCT01676961|E1|Reported Event|Supportive Care (Romiplostim)|"Patients receive romiplostim SC once weekly for up to 6 weeks. Patients achieving a platelet count > 50 x 10^9 then receive romiplostim once weekly during 1 course of chemotherapy and may continue for as long as benefit is seen..~romiplostim: Given SC"
169790|NCT01676896|B4|Baseline|Total|Total of all reporting groups
169791|NCT01676896|B3|Baseline|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169903|NCT01676701|O1|Outcome|Tabalumab Auto-Injector|Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
169792|NCT01676896|B2|Baseline|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169793|NCT01676896|B1|Baseline|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169794|NCT01676896|P3|Participant Flow|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169795|NCT01676896|P2|Participant Flow|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169796|NCT01676896|P1|Participant Flow|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169797|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169798|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169799|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169800|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169801|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169802|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169931|NCT01676532|O1|Outcome|Number of Students Attending SBHC With New Diagnoses|Porportion of students attending SBHC with new diagnoses
183868|NCT01627002|O4|Outcome|Part A PA401 3.0 mg|
169803|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169804|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169805|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169806|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169807|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169808|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169809|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169810|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169811|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169812|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169813|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169825|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169814|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169815|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169816|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169817|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169818|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169819|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169820|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169821|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169822|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169823|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169824|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169848|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
171363|NCT01672242|E2|Reported Event|CPAP|Continuous positive airway pressure
169826|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169827|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169828|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169829|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169830|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169831|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169832|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169833|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169834|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169835|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169836|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169860|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
171364|NCT01672242|E1|Reported Event|HFNC|High flow nasal cannula
169837|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169838|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169839|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169840|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169841|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169842|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169843|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169844|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169845|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169846|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169847|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169932|NCT01676532|O1|Outcome|Number of Students Attending SBHC With New Treatment Plans|The total number of students who attended SBHC that had new treatment plans proposed
183869|NCT01627002|O3|Outcome|Part A PA401 1.0 mg|
169849|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169850|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169851|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169852|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169853|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169854|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169855|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169856|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169857|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169858|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169859|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169933|NCT01676532|O1|Outcome|Students Attending SBHC|Students who were enrolled at the SBHC and then attended the SBHC
174277|NCT01661764|O4|Outcome|rs174535 (GT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
169861|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169862|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169863|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169864|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169865|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169866|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169867|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169868|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169869|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169870|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169871|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169934|NCT01676532|E1|Reported Event|Students Attending SBHC|Students who attend the SBHC from either Sprucecourt Public School or any other participating schools.
169935|NCT01676415|B3|Baseline|Total|Total of all reporting groups
169872|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169873|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169874|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169875|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169876|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169877|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169878|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169879|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169880|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169881|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169882|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169901|NCT01676701|P1|Participant Flow|Tabalumab Auto-Injector|Tabalumab: Using auto-injectors, participants received a 180 milligram (mg) loading dose at Week 0 as 2 subcutaneous (SC) injections (90 mg each). Participants also received a 90 mg SC injection every 2 weeks (Q2W) until early study termination (up to Week 6).
169902|NCT01676701|O2|Outcome|Tabalumab Prefilled Syringe|Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
169883|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169884|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169885|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169886|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169887|NCT01676896|E3|Reported Event|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
169888|NCT01676896|E2|Reported Event|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
169889|NCT01676896|E1|Reported Event|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
169890|NCT01676714|B1|Baseline|Dovitinib|"500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.~Dovitinib"
169891|NCT01676714|P1|Participant Flow|Dovitinib|500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
169892|NCT01676714|O1|Outcome|Dovitinib|500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
169893|NCT01676714|O1|Outcome|Dovitinib|500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
169894|NCT01676714|O1|Outcome|Dovitinib|500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
169895|NCT01676714|O1|Outcome|Dovitinib|500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days.
169896|NCT01676714|E1|Reported Event|Dovitinib|500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
169897|NCT01676701|B3|Baseline|Total|Total of all reporting groups
169898|NCT01676701|B2|Baseline|Tabalumab Prefilled Syringe|Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
169899|NCT01676701|B1|Baseline|Tabalumab Auto-Injector|Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
169900|NCT01676701|P2|Participant Flow|Tabalumab Prefilled Syringe|Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
169999|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
169904|NCT01676701|O2|Outcome|Tabalumab Prefilled Syringe|Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
169905|NCT01676701|O1|Outcome|Tabalumab Auto-Injector|Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
169906|NCT01676701|O2|Outcome|Tabalumab Prefilled Syringe|Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
169907|NCT01676701|O1|Outcome|Tabalumab Auto-Injector|Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
169908|NCT01676701|O2|Outcome|Tabalumab Prefilled Syringe|Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
169909|NCT01676701|O1|Outcome|Tabalumab Auto-Injector|Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
169910|NCT01676701|O2|Outcome|Tabalumab Prefilled Syringe|Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
169911|NCT01676701|O1|Outcome|Tabalumab Auto-Injector|Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
169912|NCT01676701|O2|Outcome|Tabalumab Prefilled Syringe|Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
169913|NCT01676701|O1|Outcome|Tabalumab Auto-Injector|Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
169914|NCT01676701|O2|Outcome|Tabalumab Prefilled Syringe|Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
169915|NCT01676701|O1|Outcome|Tabalumab Auto-Injector|Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
169916|NCT01676701|O2|Outcome|Tabalumab Prefilled Syringe|Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
169917|NCT01676701|O1|Outcome|Tabalumab Auto-Injector|Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
169918|NCT01676701|O2|Outcome|Tabalumab Prefilled Syringe|Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
169919|NCT01676701|O1|Outcome|Tabalumab Auto-Injector|Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
169920|NCT01676701|O2|Outcome|Tabalumab Prefilled Syringe|Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
169921|NCT01676701|O1|Outcome|Tabalumab Auto-Injector|Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
169922|NCT01676701|E4|Reported Event|Tabalumab Prefilled Syringe (Post Treatment Follow-Up Period)|No study drug was administered during the Post-Treatment Follow-Up Period for participants in the Tabalumab Prefilled Syringe treatment arm.
169923|NCT01676701|E3|Reported Event|Tabalumab Prefilled Syringe (Treatment Period)|Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
169924|NCT01676701|E2|Reported Event|Tabalumab Auto-Injector (Post Treatment Follow-Up Period)|No study drug was administered during the Post-Treatment Follow-Up Period for participants in the Tabalumab Auto-Injector treatment arm.
169925|NCT01676701|E1|Reported Event|Tabalumab Auto-Injector (Treatment Period)|Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
169926|NCT01676532|B1|Baseline|Students Attending SBHC|"Students who attend the SBHC from either Sprucecourt Public School or any other participating schools.~Students attending SBHC: School based health clinic. This is a cohort study as such there is only one group of children who used the SBHC"
169927|NCT01676532|P1|Participant Flow|Students Attending SBHC|Students who attend the SBHC from either Sprucecourt Public School or any other participating schools.
169928|NCT01676532|O1|Outcome|Sprucecourt Public School Vs Other Participating Schools|The number of students from the host school of the SBHC and other participating schools
169929|NCT01676532|O1|Outcome|Number of Students From Sprucecourt Who Enrolled in SBHC|From the total number of students who enrolled in the SBHC, the number of students from the host school (Sprucecourt) was calculated
169930|NCT01676532|O1|Outcome|Number of Referrals Made for Students Attending SBHC|Types and number of referrals made for students attending SBHC.
169936|NCT01676415|B2|Baseline|Topical Mometasone|"Topical steroid medication~Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study."
169937|NCT01676415|B1|Baseline|Prednisone|"Oral steroid medication~Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days~Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study"
169938|NCT01676415|P2|Participant Flow|Topical Mometasone|"Topical steroid medication~Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study."
169939|NCT01676415|P1|Participant Flow|Prednisone|"Oral steroid medication~Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days~Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study"
169940|NCT01676415|O2|Outcome|Topical Mometasone|"Topical steroid medication~Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study."
169941|NCT01676415|O1|Outcome|Prednisone|"Oral steroid medication~Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days~Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study"
169942|NCT01676415|O2|Outcome|Topical Mometasone|"Topical steroid medication~Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study."
169943|NCT01676415|O1|Outcome|Prednisone|"Oral steroid medication~Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days~Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study"
169944|NCT01676415|O2|Outcome|Topical Mometasone|"Topical steroid medication~Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study."
169945|NCT01676415|O1|Outcome|Prednisone|"Oral steroid medication~Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days~Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study"
169946|NCT01676415|O2|Outcome|Topical Mometasone|"Topical steroid medication~Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study."
169947|NCT01676415|O1|Outcome|Prednisone|"Oral steroid medication~Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days~Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study"
170000|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
174874|NCT01660022|O9|Outcome|Cohort 5 - OZ439 800mg|Cohort 5 - Sequence 1 OZ439 800mg
169948|NCT01676415|E2|Reported Event|Topical Mometasone|"Topical steroid medication~Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study."
169949|NCT01676415|E1|Reported Event|Prednisone|"Oral steroid medication~Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days~Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study"
169950|NCT01676298|B9|Baseline|Total|Total of all reporting groups
169951|NCT01676298|B8|Baseline|*2/*17 CYP2C19 Genotype|
169952|NCT01676298|B7|Baseline|*2/*3 CYP2C19 Genotype|
169953|NCT01676298|B6|Baseline|*17/*17 CYP2C19 Genotype|
169954|NCT01676298|B5|Baseline|*1/*17 CYP2C19 Genotype|
169955|NCT01676298|B4|Baseline|*3/*1 CYP2C19 Genotype|
169956|NCT01676298|B3|Baseline|*2/*2 CYP2C19 Genotype|
169957|NCT01676298|B2|Baseline|*1/*2 CYP2C19 Genotype|
169958|NCT01676298|B1|Baseline|*1/*1 CYP2C19 Genotype|
169959|NCT01676298|P8|Participant Flow|*2/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
169960|NCT01676298|P7|Participant Flow|*2/*3 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
169961|NCT01676298|P6|Participant Flow|*17/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
169962|NCT01676298|P5|Participant Flow|*1/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
169963|NCT01676298|P4|Participant Flow|*3/*1 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
169964|NCT01676298|P3|Participant Flow|*2/*2 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
169965|NCT01676298|P2|Participant Flow|*1/*2 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
169966|NCT01676298|P1|Participant Flow|*1/*1 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
169967|NCT01676298|O8|Outcome|*2/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
169968|NCT01676298|O7|Outcome|*2/*3 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
169969|NCT01676298|O6|Outcome|*17/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
169970|NCT01676298|O5|Outcome|*1/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
169971|NCT01676298|O4|Outcome|*3/*1 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
169972|NCT01676298|O3|Outcome|*2/*2 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
169973|NCT01676298|O2|Outcome|*1/*2 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
169974|NCT01676298|O1|Outcome|*1/*1 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
169975|NCT01676298|E8|Reported Event|*2/*17 CYP2C19 Genotype|
169976|NCT01676298|E7|Reported Event|*2/*3 CYP2C19 Genotype|
169977|NCT01676298|E6|Reported Event|*17/*17 CYP2C19 Genotype|
169978|NCT01676298|E5|Reported Event|*1/*17 CYP2C19 Genotype|
169979|NCT01676298|E4|Reported Event|*3/*1 CYP2C19 Genotype|
169980|NCT01676298|E3|Reported Event|*2/*2 CYP2C19 Genotype|
169981|NCT01676298|E2|Reported Event|*1/*2 CYP2C19 Genotype|
169982|NCT01676298|E1|Reported Event|*1/*1 CYP2C19 Genotype|
169983|NCT01676220|B3|Baseline|Total|Total of all reporting groups
169984|NCT01676220|B2|Baseline|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
169985|NCT01676220|B1|Baseline|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
169986|NCT01676220|P2|Participant Flow|Lantus (Insulin Glargine)|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with non-insulin antihyperglycemic drug(s).
169987|NCT01676220|P1|Participant Flow|HOE901-U300|HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months in combination with non-insulin antihyperglycemic drug(s).
169988|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
169989|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
169990|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
169991|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
169992|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
169993|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
169994|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
169995|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
169996|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of non-insulin antihyperglycemic drug(s).
169997|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of non-insulin antihyperglycemic drug(s).
169998|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
170001|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
170002|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
170003|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
170004|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
170005|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
170006|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
170007|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
170008|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
170009|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
170010|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
170011|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
170012|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
170013|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
170014|NCT01676220|E2|Reported Event|Lantus|Lantus SC injection once daily for 12 months in combination with non­insulin antihyperglycemic drug(s).
170015|NCT01676220|E1|Reported Event|HOE901-U300|HOE901­U300 SC injection once daily for 12 months in combination with non­insulin antihyperglycemic drug(s).
170016|NCT01676012|B1|Baseline|Five Types of Bronchoscopy|"Bronchoscopy will be performed in a standardized order using five different imaging modes.~Standard white light videobronchoscopy (WLB)~High Definition -Bronchoscopy~HD-bronchoscopy + surface enhancement (iScan-surface)~HD-bronchoscopy + tone enhancement (iScan-tone)~Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode"
170017|NCT01676012|P1|Participant Flow|Five Types of Bronchoscopy|"Standard white light videobronchoscopy (WLB)~High Definition -Bronchoscopy~HD-bronchoscopy + surface enhancement (iScan-surface)~HD-bronchoscopy + tone enhancement (iScan-tone)~Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode"
170018|NCT01676012|O1|Outcome|Five Types of Bronchoscopy|"Bronchoscopy will be performed in a standardized order using five different imaging modes.~Standard white light videobronchoscopy (WLB)~High Definition -Bronchoscopy~HD-bronchoscopy + surface enhancement (iScan-surface)~HD-bronchoscopy + tone enhancement (iScan-tone)~Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode"
170019|NCT01676012|E1|Reported Event|Five Types of Bronchoscopy|"Bronchoscopy will be performed in a standardized order using five different imaging modes.~Standard white light videobronchoscopy (WLB)~High Definition -Bronchoscopy~HD-bronchoscopy + surface enhancement (iScan-surface)~HD-bronchoscopy + tone enhancement (iScan-tone)~Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode"
170020|NCT01675830|B1|Baseline|Head Wrap Device|Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
170021|NCT01675830|P1|Participant Flow|Head Wrap Device|Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
170022|NCT01675830|O1|Outcome|Head Wrap Device|Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
170023|NCT01675830|O1|Outcome|Head Wrap Device|Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
170024|NCT01675830|E1|Reported Event|Head Wrap Device|Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
170025|NCT01675661|B3|Baseline|Total|Total of all reporting groups
170026|NCT01675661|B2|Baseline|Placebo Plus CM|"Placebo plus Contingency Management (CM)~Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
170027|NCT01675661|B1|Baseline|NAC Plus CM|"N-acetylcysteine (NAC) plus Contingency Management (CM)~N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
170028|NCT01675661|P2|Participant Flow|Placebo Plus CM|"Placebo plus Contingency Management (CM)~Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
170029|NCT01675661|P1|Participant Flow|NAC Plus CM|"N-acetylcysteine (NAC) plus Contingency Management (CM)~N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
170030|NCT01675661|O2|Outcome|Placebo Plus CM|"Placebo plus Contingency Management (CM)~Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
170031|NCT01675661|O1|Outcome|NAC Plus CM|"N-acetylcysteine (NAC) plus Contingency Management (CM)~N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
170032|NCT01675661|E2|Reported Event|Placebo Plus CM|"Placebo plus Contingency Management (CM)~Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
170070|NCT01675622|O2|Outcome|Morphine Tablets for Cancer Pain|Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
170033|NCT01675661|E1|Reported Event|NAC Plus CM|"N-acetylcysteine (NAC) plus Contingency Management (CM)~N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
170034|NCT01675635|B3|Baseline|Total|Total of all reporting groups
170035|NCT01675635|B2|Baseline|Morphine Tablet|"To determine the efficacy and safety of Morphine tablet.~Morphine tablet: dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours."
170036|NCT01675635|B1|Baseline|OxyNorm Capsules|"To determine the efficacy and safety of OxyNorm Capsules.~OxyNorm Capsules: dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours"
170037|NCT01675635|P2|Participant Flow|Morphine Tablet|"To determine the efficacy and safety of Morphine tablet.~Morphine tablet: dosage: 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours."
170038|NCT01675635|P1|Participant Flow|OxyNorm Capsules|"To determine the efficacy and safety of OxyNorm Capsules.~OxyNorm Capsules: dosage:l0mg dosage form:capsule frequency:every 6h, duration:24 hours"
170039|NCT01675635|O2|Outcome|Morphine Tablet|"To determine the efficacy and safety of Morphine tablet.~Morphine tablet: dosage: 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours."
170040|NCT01675635|O1|Outcome|OxyNorm Capsules|"To determine the efficacy and safety of OxyNorm Capsules.~OxyNorm Capsules: dosage: l0mg dosage form:capsule frequency:every 6h, duration:24 hours"
170041|NCT01675635|O2|Outcome|Morphine Tablet:|"To determine the efficacy and safety of Morphine tablet.~dosage: 20mg dosage form: tablet; frequency: every 6h; duration: 24 hours."
170042|NCT01675635|O1|Outcome|OxyNorm Capsules|"To determine the efficacy and safety of OxyNorm Capsules.~OxyNorm Capsules: dosage: l0mg dosage form:capsule frequency:every 6h, duration:24 hours"
170043|NCT01675635|O2|Outcome|Morphine Tablet|"To determine the efficacy and safety of Morphine tablet.~Morphine tablet: dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours."
170044|NCT01675635|O1|Outcome|OxyNorm Capsules|"To determine the efficacy and safety of OxyNorm Capsules.~OxyNorm Capsules: dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours"
170045|NCT01675635|O2|Outcome|Morphine Tablet|"To determine the efficacy and safety of Morphine tablet.~Morphine tablet: dosage: 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours."
170046|NCT01675635|O1|Outcome|OxyNorm Capsules|"To determine the efficacy and safety of OxyNorm Capsules.~OxyNorm Capsules: dosage:l0mg dosage form:capsule frequency:every 6h, duration:24 hours"
170047|NCT01675635|O2|Outcome|Morphine Tablet|"To determine the efficacy and safety of Morphine tablet.~Morphine tablet: dosage:20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours."
170048|NCT01675635|O1|Outcome|OxyNorm Capsules|"To determine the efficacy and safety of OxyNorm Capsules.~OxyNorm Capsules: dosage:l0mg dosage form:capsule frequency:every 6h, duration:24 hours"
170049|NCT01675635|O2|Outcome|Morphine Tablet|"To determine the efficacy and safety of Morphine tablet.~Morphine tablet: dosage: 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours."
170050|NCT01675635|O1|Outcome|OxyNorm Capsules|"To determine the efficacy and safety of OxyNorm Capsules.~OxyNorm Capsules: dosage:l0mg dosage form:capsule frequency:every 6h, duration:24 hours"
170051|NCT01675635|O2|Outcome|Morphine Tablet|"To determine the efficacy and safety of Morphine tablet.~Morphine tablet: dosage: 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours."
170052|NCT01675635|O1|Outcome|OxyNorm Capsules|"To determine the efficacy and safety of OxyNorm Capsules.~OxyNorm Capsules: dosage: l0mg dosage form:capsule frequency:every 6h, duration:24 hours"
170053|NCT01675635|E2|Reported Event|Morphine Tablet|"To determine the efficacy and safety of Morphine tablet.~Morphine tablet: dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours."
170054|NCT01675635|E1|Reported Event|OxyNorm Capsules|"To determine the efficacy and safety of OxyNorm Capsules.~OxyNorm Capsules: dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours"
170055|NCT01675622|B3|Baseline|Total|Total of all reporting groups
170056|NCT01675622|B2|Baseline|Morphine Tablets for Cancer Pain|Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
170057|NCT01675622|B1|Baseline|Oxycodone Capsules for Cancer Pain|Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
170058|NCT01675622|P2|Participant Flow|Morphine Tablets for Cancer Pain|"Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours. All patients completed the double-blind treatment entered into period 2.~period 2 is open treatment phase. Patients received two weeks treatment of oxycodone hydrochloride controlled-release tablets."
170059|NCT01675622|P1|Participant Flow|Oxycodone Capsules for Cancer Pain|"Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days. All patients completed the double-blind treatment entered into period 2.~period 2 is open treatment phase. Patients received two weeks treatment of oxycodone hydrochloride controlled-release tablets."
170060|NCT01675622|O2|Outcome|Morphine Tablets for Cancer Pain|Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
170061|NCT01675622|O1|Outcome|Oxycodone Capsules for Cancer Pain|Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
170062|NCT01675622|O2|Outcome|Morphine Tablets for Cancer Pain|Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
170063|NCT01675622|O1|Outcome|Oxycodone Capsules for Cancer Pain|Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
170064|NCT01675622|O2|Outcome|Morphine Tablets for Cancer Pain|Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
170065|NCT01675622|O1|Outcome|Oxycodone Capsules for Cancer Pain|Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
170066|NCT01675622|O2|Outcome|Morphine Tablets for Cancer Pain|Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
170067|NCT01675622|O1|Outcome|Oxycodone Capsules for Cancer Pain|Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
170068|NCT01675622|O2|Outcome|Morphine Tablets for Cancer Pain|Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
170069|NCT01675622|O1|Outcome|Oxycodone Capsules for Cancer Pain|Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
170071|NCT01675622|O1|Outcome|Oxycodone Capsules for Cancer Pain|Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
170072|NCT01675622|O2|Outcome|Morphine Tablets for Cancer Pain|Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
170073|NCT01675622|O1|Outcome|Oxycodone Capsules for Cancer Pain|Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
170074|NCT01675622|O2|Outcome|Morphine Tablets for Cancer Pain|Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
170075|NCT01675622|O1|Outcome|Oxycodone Capsules for Cancer Pain|Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
170076|NCT01675622|O2|Outcome|Morphine Tablets for Cancer Pain|Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
170077|NCT01675622|O1|Outcome|Oxycodone Capsules for Cancer Pain|Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
170078|NCT01675622|O2|Outcome|Morphine Tablets for Cancer Pain|Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
170079|NCT01675622|O1|Outcome|Oxycodone Capsules for Cancer Pain|Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
170080|NCT01675622|E2|Reported Event|Morphine Tablets for Cancer Pain|Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
170081|NCT01675622|E1|Reported Event|Oxycodone Capsules for Cancer Pain|Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
170082|NCT01675544|B1|Baseline|Heart Failure Admission|"Patients admitted for acute decompensated heart failure~Electrocardiogram: EKG voltage changes between admission and discharge~Six minute walk test"
170083|NCT01675544|P1|Participant Flow|Heart Failure Admission|"Patients admitted for acute decompensated heart failure~Electrocardiogram: EKG voltage changes between admission and discharge~Six minute walk test"
170084|NCT01675544|O1|Outcome|Heart Failure Admission|"Patients admitted for acute decompensated heart failure~Electrocardiogram: EKG voltage changes between admission and discharge~Six minute walk test"
170085|NCT01675544|O1|Outcome|Heart Failure Admission|"Patients admitted for acute decompensated heart failure~Electrocardiogram: EKG voltage changes between admission and discharge~Six minute walk test"
170086|NCT01675544|E1|Reported Event|Heart Failure Admission|"Patients admitted for acute decompensated heart failure~Electrocardiogram: EKG voltage changes between admission and discharge~Six minute walk test"
170087|NCT01675531|B1|Baseline|Oxycodone/Naloxone|"Targin~Targin: Single arm for Targin"
170088|NCT01675531|P1|Participant Flow|Oxycontin/Naloxone|"Targin(Oxycontin/Naloxone)~Targin: Single arm for Targin"
170089|NCT01675531|O1|Outcome|Oxycontin/Naloxone|"Targin(Oxycontin/Naloxone)~Targin: Single arm for Targin"
170090|NCT01675531|O1|Outcome|Oxycontin/Naloxone|"Targin(Oxycontin/Naloxone)~Targin: Single arm for Targin"
170091|NCT01675531|O1|Outcome|Oxycontin/Naloxone|"Targin(Oxycontin/Naloxone)~Targin: Single arm for Targin"
170092|NCT01675531|O1|Outcome|Oxycodone/Naloxone|"Targin~Targin: Single arm for Targin"
170093|NCT01675531|E1|Reported Event|Oxycodone/Naloxone|"Targin(Oxycodone/Naloxone)~Targin: Single arm for Targin"
170094|NCT01675492|B1|Baseline|Wave-front Guided LASIK|LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for mixed astigmatism refraction
170095|NCT01675492|P1|Participant Flow|Wave-front Guided LASIK|Vision correction for a mixed astigmatism refraction
170096|NCT01675492|O1|Outcome|Wave-front Guided LASIK|LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for mixed astigmatism refraction
170097|NCT01675492|O1|Outcome|Wave-front Guided LASIK|LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for a mixed astigmatism refraction
170098|NCT01675492|E1|Reported Event|Wave-front Guided LASIK|LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for mixed astigmatism refraction
170099|NCT01675479|B1|Baseline|Wavefront-Guided LASIK|LASIK : Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System for correction of hyperopic refractive errors
170100|NCT01675479|P1|Participant Flow|Wavefront-Guided LASIK|LASIK correction of hyperopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
170101|NCT01675479|O1|Outcome|Wavefront-Guided LASIK|LASIK : Surgeons performed wavefront-guided LASIK based upon measurement obtained with the iDesign System for correction of hyperopic refractive errors
170102|NCT01675479|O1|Outcome|Wavefront-Guided LASIK|LASIK : Surgeons performed wavefront-guided LASIK based upon measurement obtained with the iDesign System for correction of hyperopic refractive errors
170103|NCT01675479|E1|Reported Event|Wavefront-Guided LASIK|LASIK : Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System for correction of hyperopic refractive errors
170104|NCT01675453|B3|Baseline|Total|Total of all reporting groups
170105|NCT01675453|B2|Baseline|0.9% NaCl (Control Group)|"On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~0.9% NaCl"
170106|NCT01675453|B1|Baseline|7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group)|"On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~7.2% NaCl plus 6% hydroxyethyl starch 200/0.5"
170107|NCT01675453|P2|Participant Flow|0.9% NaCl (Control Group)|"On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~0.9% NaCl"
170108|NCT01675453|P1|Participant Flow|7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group)|"On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~7.2% NaCl plus 6% hydroxyethyl starch 200/0.5"
170109|NCT01675453|O2|Outcome|0.9% NaCl (Control Group)|"On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~0.9% NaCl"
170485|NCT01674725|B3|Baseline|Total|Total of all reporting groups
170110|NCT01675453|O1|Outcome|7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group)|"On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~7.2% NaCl plus 6% hydroxyethyl starch 200/0.5"
170111|NCT01675453|E2|Reported Event|0.9% NaCl (Control Group)|"On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~0.9% NaCl"
170112|NCT01675453|E1|Reported Event|7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group)|"On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~7.2% NaCl plus 6% hydroxyethyl starch 200/0.5"
170113|NCT01675427|B1|Baseline|Participants With CHC|Both treatment-naive and treatment-experienced participants with CHC were enrolled in this prospective, interventional Phase 4 study.
170114|NCT01675427|P1|Participant Flow|Participants With Chronic Hepatitis C (CHC)|Both treatment-naive and treatment-experienced participants with CHC were enrolled in this prospective, interventional Phase 4 study.
170115|NCT01675427|O3|Outcome|Experienced: ITPA rs7270101 AA|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
170116|NCT01675427|O2|Outcome|Experienced: ITPA rs7270101 AC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
170117|NCT01675427|O1|Outcome|Experienced: ITPA rs7270101 CC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
170118|NCT01675427|O3|Outcome|Experienced: ITPA rs1127354 CC|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
170119|NCT01675427|O2|Outcome|Experienced: ITPA rs1127354 CA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
170120|NCT01675427|O1|Outcome|Experienced: ITPA rs1127354 AA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
170121|NCT01675427|O3|Outcome|Experienced: ITPA rs7270101 AA|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
170122|NCT01675427|O2|Outcome|Experienced: ITPA rs7270101 AC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
170123|NCT01675427|O1|Outcome|Experienced: ITPA rs7270101 CC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
170124|NCT01675427|O3|Outcome|Experienced: ITPA rs1127354 CC|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
170125|NCT01675427|O2|Outcome|Experienced: ITPA rs1127354 CA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
170126|NCT01675427|O1|Outcome|Experienced: ITPA rs1127354 AA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
170127|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170128|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170129|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170130|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170131|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170132|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170133|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170134|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170135|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170136|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170137|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170138|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170139|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170140|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170141|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170142|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170143|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170144|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170145|NCT01675427|O3|Outcome|Experienced: ITPA rs7270101 AA|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
170146|NCT01675427|O2|Outcome|Experienced: ITPA rs7270101 AC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
183870|NCT01627002|O2|Outcome|Part A PA401 0.3 mg|
170147|NCT01675427|O1|Outcome|Experienced: ITPA rs7270101 CC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
170148|NCT01675427|O3|Outcome|Experienced: ITPA rs7270101 AA|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
170149|NCT01675427|O2|Outcome|Experienced: ITPA rs7270101 AC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
170150|NCT01675427|O1|Outcome|Experienced: ITPA rs7270101 CC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
170151|NCT01675427|O3|Outcome|Naive: ITPA rs7270101 AA|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
170152|NCT01675427|O2|Outcome|Naive: ITPA rs7270101 AC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
170153|NCT01675427|O1|Outcome|Naive: ITPA rs7270101 CC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
170154|NCT01675427|O3|Outcome|Naive: ITPA rs7270101 AA|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
170155|NCT01675427|O2|Outcome|Naive: ITPA rs7270101 AC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
170156|NCT01675427|O1|Outcome|Naive: ITPA rs7270101 CC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
170157|NCT01675427|O3|Outcome|Experienced: ITPA rs1127354 CC|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
170158|NCT01675427|O2|Outcome|Experienced: ITPA rs1127354 CA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
170159|NCT01675427|O1|Outcome|Experienced: ITPA rs1127354 AA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
170160|NCT01675427|O3|Outcome|Experienced: ITPA rs1127354 CC|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
170161|NCT01675427|O2|Outcome|Experienced: ITPA rs1127354 CA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
170162|NCT01675427|O1|Outcome|Experienced: ITPA rs1127354 AA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
170163|NCT01675427|O3|Outcome|Naive: ITPA rs1127354 CC|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
170164|NCT01675427|O2|Outcome|Naive: ITPA rs1127354 CA|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
170165|NCT01675427|O1|Outcome|Naive: ITPA rs1127354 AA|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
170166|NCT01675427|O3|Outcome|Naive: ITPA rs1127354 CC|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
170167|NCT01675427|O2|Outcome|Naive: ITPA rs1127354 CA|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
170168|NCT01675427|O1|Outcome|Naive: ITPA rs1127354 AA|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
170169|NCT01675427|O3|Outcome|Experienced: ITPA rs7270101 AA|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
170170|NCT01675427|O2|Outcome|Experienced: ITPA rs7270101 AC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
170171|NCT01675427|O1|Outcome|Experienced: ITPA rs7270101 CC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
170172|NCT01675427|O3|Outcome|Naive: ITPA rs7270101 AA|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
170173|NCT01675427|O2|Outcome|Naive: ITPA rs7270101 AC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
170174|NCT01675427|O1|Outcome|Naive: ITPA rs7270101 CC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
170175|NCT01675427|O3|Outcome|Experienced: ITPA rs1127354 CC|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
170176|NCT01675427|O2|Outcome|Experienced: ITPA rs1127354 CA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
170177|NCT01675427|O1|Outcome|Experienced: ITPA rs1127354 AA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
170178|NCT01675427|O3|Outcome|Naive: ITPA rs1127354 CC|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
170179|NCT01675427|O2|Outcome|Naive: ITPA rs1127354 CA|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
170180|NCT01675427|O1|Outcome|Naive: ITPA rs1127354 AA|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
170181|NCT01675427|O3|Outcome|Experienced: ITPA rs7270101 AA|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
170182|NCT01675427|O2|Outcome|Experienced: ITPA rs7270101 AC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
170183|NCT01675427|O1|Outcome|Experienced: ITPA rs7270101 CC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
170184|NCT01675427|O3|Outcome|Naive: ITPA rs7270101 Alanine-Alanine (AA)|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
170185|NCT01675427|O2|Outcome|Naive: ITPA rs7270101 Alanine-Cysteine (AC)|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
170186|NCT01675427|O1|Outcome|Naive: ITPA rs7270101 CC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
170187|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
183871|NCT01627002|O1|Outcome|Part A PA401 0.1 mg|
170188|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170189|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170190|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170191|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170192|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170193|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170194|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170195|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170196|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170197|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170198|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170199|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170200|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170201|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170202|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170203|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170204|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170205|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170206|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170207|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170208|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170209|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170210|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170211|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170212|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170213|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170214|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170215|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170216|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170217|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170218|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170219|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170220|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170221|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170222|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170223|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170224|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170225|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170226|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170227|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170228|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170229|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170230|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170231|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170232|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170233|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170234|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170235|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170236|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170237|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170238|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170239|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170240|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170241|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170242|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170243|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170244|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170245|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170246|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170247|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170248|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170249|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170250|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170251|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170252|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170253|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170254|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170255|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170256|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170257|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170258|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170259|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170260|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170261|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170262|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170263|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170264|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170265|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170266|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170267|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170268|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170269|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170270|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170271|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170272|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170273|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170274|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170275|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170276|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170277|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170278|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170279|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170280|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170281|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170282|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170283|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170284|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170285|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170286|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170287|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170288|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170289|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170290|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170291|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170292|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170293|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170294|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170295|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170296|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170297|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170298|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170299|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170300|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170301|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170302|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170303|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170304|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170305|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170306|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170307|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170308|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170309|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170310|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170311|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170312|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170313|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170314|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170315|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170316|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170317|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170318|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170319|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170320|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170321|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170322|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170323|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170324|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170325|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170326|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170327|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170328|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170329|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170330|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170331|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170332|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170333|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170334|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170335|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170336|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170337|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170338|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170339|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170340|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170341|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170342|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170343|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170344|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170345|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170346|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170347|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170348|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170349|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170350|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170351|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170352|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170353|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170354|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170355|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170356|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170357|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170358|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170359|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170360|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170361|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170362|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170363|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170364|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170365|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170366|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170367|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170368|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170369|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170370|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170371|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170372|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170373|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170374|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170375|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170376|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170377|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170378|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170379|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170380|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170381|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170382|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170383|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170384|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170385|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170386|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170387|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170388|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 Glycine-Glycine (GG)|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
170389|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 Threonine-Glycine (TG)|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
170390|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
170391|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170392|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170393|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170394|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 Threonine-Threonine (TT)|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
170395|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 Threonine-Cysteine (TC)|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
170396|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 Cysteine-Cysteine (CC)|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
170397|NCT01675427|E1|Reported Event|Participants With CHC|Both treatment-naive and treatment-experienced participants with CHC were enrolled in this prospective, interventional Phase 4 study.
170398|NCT01675167|B3|Baseline|Total|Total of all reporting groups
170399|NCT01675167|B2|Baseline|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
170400|NCT01675167|B1|Baseline|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
170401|NCT01675167|P3|Participant Flow|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
170402|NCT01675167|P2|Participant Flow|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
170403|NCT01675167|P1|Participant Flow|OL Buprenorphine HCl Buccal Film|Buprenorphine hydrochloride (HCl) buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration period
170404|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
170405|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
170406|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
170407|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
170408|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
170409|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
170410|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
170411|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
170412|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
170413|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
170414|NCT01675167|O1|Outcome|OL Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration period
170415|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
170416|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
170417|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
170418|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
170419|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
170420|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
170421|NCT01675167|E3|Reported Event|DB Placebo Film|Placebo buccal film, 150, 300, 450, 600, 750, or 900 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind titration period
170422|NCT01675167|E2|Reported Event|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind titration period
170423|NCT01675167|E1|Reported Event|OL Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 µg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration period
170424|NCT01675141|B1|Baseline|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.~Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
170425|NCT01675141|P1|Participant Flow|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.~Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
170426|NCT01675141|O1|Outcome|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.~Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
170427|NCT01675141|O1|Outcome|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.~Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
170428|NCT01675141|O1|Outcome|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.~Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
170429|NCT01675141|O1|Outcome|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.~Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
170430|NCT01675141|O1|Outcome|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.~Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
170431|NCT01675141|O1|Outcome|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.~Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
170432|NCT01675141|O1|Outcome|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.~Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
170433|NCT01675141|E1|Reported Event|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.~Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
170434|NCT01675128|B4|Baseline|Total|Total of all reporting groups
170435|NCT01675128|B3|Baseline|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
170436|NCT01675128|B2|Baseline|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
170437|NCT01675128|B1|Baseline|Phase I Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 started 800mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
170438|NCT01675128|P3|Participant Flow|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
170439|NCT01675128|P2|Participant Flow|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
170440|NCT01675128|P1|Participant Flow|Phase I Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 started 800 mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
170441|NCT01675128|O1|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
170442|NCT01675128|O1|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
170443|NCT01675128|O1|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
170444|NCT01675128|O1|Outcome|Phase I Dose Level I & Phase I Dose Level II|"Irinotecan 160 mg/m^2 every other week; ISIS 183750 started 800 mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.~Phase I Dose Level II Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks."
170445|NCT01675128|O2|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
170446|NCT01675128|O1|Outcome|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
170447|NCT01675128|O2|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
170448|NCT01675128|O1|Outcome|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
170449|NCT01675128|O2|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
170450|NCT01675128|O1|Outcome|Phase I Dose Level 2|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
170451|NCT01675128|O3|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
183872|NCT01627002|O9|Outcome|Part B Placebo|
170452|NCT01675128|O2|Outcome|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
170453|NCT01675128|O1|Outcome|Phase I Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 started 800 mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
170454|NCT01675128|O1|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
170455|NCT01675128|O1|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
170456|NCT01675128|O1|Outcome|All Phase I Participants|Irinotecan 160 (and 180) mg/m^2 every other week.
170457|NCT01675128|O1|Outcome|All Phase I Participants|ISIS 183750 started 800mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
170458|NCT01675128|E3|Reported Event|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
170459|NCT01675128|E2|Reported Event|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
170460|NCT01675128|E1|Reported Event|Phase I Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 started 800mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
170461|NCT01675063|B1|Baseline|Retia Non-Invasive Sensors|"Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.~Retia Non-Invasive Sensors: Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform."
170462|NCT01675063|P1|Participant Flow|Retia Non-Invasive Sensors|"Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.~Retia Non-Invasive Sensors: Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform."
170463|NCT01675063|O1|Outcome|Retia Non-Invasive Sensors|"Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.~Retia Non-Invasive Sensors: Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform."
170464|NCT01675063|E1|Reported Event|Retia Non-Invasive Sensors|"Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.~Retia Non-Invasive Sensors: Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform."
170465|NCT01675050|B3|Baseline|Total|Total of all reporting groups
170466|NCT01675050|B2|Baseline|Placebo Then Cyproheptadine|4 weeks of placebo (sugar pill) with crossover to 4 weeks of cyproheptadine
170467|NCT01675050|B1|Baseline|Cyproheptadine Then Placebo|4 weeks of cyproheptadine with crossover to 4 weeks of placebo.
170468|NCT01675050|P2|Participant Flow|Sugar Pill First, Than Cyproheptadine|4 weeks of placebo (sugar pill) with crossover to 4 weeks of cyproheptadine
170469|NCT01675050|P1|Participant Flow|Cyproheptadine First, Then Placebo|4 weeks of cyproheptadine with crossover to 4 weeks of placebo.
170470|NCT01675050|O2|Outcome|All Participants Post Placebo|
170471|NCT01675050|O1|Outcome|All Participants Post Cyproheptadine|
170472|NCT01675050|O2|Outcome|All Participants Post Placebo|
170473|NCT01675050|O1|Outcome|All Participants Post Cyproheptadine|
170474|NCT01675050|E2|Reported Event|Placebo|All participants while on Placebo.
170475|NCT01675050|E1|Reported Event|Cyproheptadine|All participants while on Cyproheptadine.
170476|NCT01675011|B3|Baseline|Total|Total of all reporting groups
170477|NCT01675011|B2|Baseline|Embosphere®|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embosphere®"
170478|NCT01675011|B1|Baseline|Embozene® Microspheres|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embozene® Microspheres"
170479|NCT01675011|P2|Participant Flow|Embosphere®|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embosphere®"
170480|NCT01675011|P1|Participant Flow|Embozene® Microspheres|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embozene® Microspheres"
170481|NCT01675011|O2|Outcome|Embosphere®|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embosphere®"
170482|NCT01675011|O1|Outcome|Embozene® Microspheres|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embozene® Microspheres"
170483|NCT01675011|E2|Reported Event|Embosphere®|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embosphere®"
170484|NCT01675011|E1|Reported Event|Embozene® Microspheres|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embozene® Microspheres"
170486|NCT01674725|B2|Baseline|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
170487|NCT01674725|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
170488|NCT01674725|P2|Participant Flow|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
170489|NCT01674725|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
170490|NCT01674725|O2|Outcome|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
170491|NCT01674725|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
170492|NCT01674725|O2|Outcome|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
170493|NCT01674725|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
170494|NCT01674725|O2|Outcome|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
170495|NCT01674725|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
170496|NCT01674725|O2|Outcome|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
170497|NCT01674725|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
170498|NCT01674725|O2|Outcome|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
170499|NCT01674725|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
170500|NCT01674725|E2|Reported Event|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
170501|NCT01674725|E1|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
170502|NCT01674712|B6|Baseline|Total|Total of all reporting groups
170503|NCT01674712|B5|Baseline|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
170504|NCT01674712|B4|Baseline|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
170505|NCT01674712|B3|Baseline|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
170506|NCT01674712|B2|Baseline|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
170507|NCT01674712|B1|Baseline|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
170508|NCT01674712|P5|Participant Flow|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
170509|NCT01674712|P4|Participant Flow|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
170510|NCT01674712|P3|Participant Flow|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
170511|NCT01674712|P2|Participant Flow|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
170512|NCT01674712|P1|Participant Flow|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
170513|NCT01674712|O5|Outcome|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
170514|NCT01674712|O4|Outcome|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
170515|NCT01674712|O3|Outcome|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
170516|NCT01674712|O2|Outcome|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
170517|NCT01674712|O1|Outcome|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
170518|NCT01674712|O5|Outcome|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
170519|NCT01674712|O4|Outcome|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
170520|NCT01674712|O3|Outcome|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
170521|NCT01674712|O2|Outcome|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
170522|NCT01674712|O1|Outcome|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
170523|NCT01674712|O5|Outcome|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
170524|NCT01674712|O4|Outcome|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
170525|NCT01674712|O3|Outcome|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
170526|NCT01674712|O2|Outcome|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
170527|NCT01674712|O1|Outcome|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
170528|NCT01674712|E5|Reported Event|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
170529|NCT01674712|E4|Reported Event|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
170530|NCT01674712|E3|Reported Event|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
170531|NCT01674712|E2|Reported Event|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
170532|NCT01674712|E1|Reported Event|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
170533|NCT01674647|B3|Baseline|Total|Total of all reporting groups
170534|NCT01674647|B2|Baseline|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
170535|NCT01674647|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
170536|NCT01674647|P2|Participant Flow|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
170537|NCT01674647|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
170538|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
170539|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
170598|NCT01674621|O5|Outcome|BA058 (Abaloparatide) Injection (80 mcg)|"BA058 (abaloparatide-SC) Subcutaneous Injection - 80 mcg daily~BA058 Injection (80 mcg): BA058 Subcutaneous Injection, 80 mcg, daily injections for 6 months"
170540|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
170541|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
170542|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
170543|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
170544|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
170545|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
170546|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
170592|NCT01674621|O1|Outcome|BA058 (Abaloparatide) Transdermal Placebo (0 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch 0 mcg daily~BA058 Placebo: BA058 Transdermal Microneedle Placebo Patch, 0 mcg, daily applications for 6 months"
170593|NCT01674621|O5|Outcome|BA058 (Abaloparatide) Injection (80 mcg)|"BA058 (abaloparatide-SC) Subcutaneous Injection - 80 mcg daily~BA058 Injection (80 mcg): BA058 Subcutaneous Injection, 80 mcg, daily injections for 6 months"
183873|NCT01627002|O8|Outcome|Part B PA401 3.0 mg|
170547|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
170548|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
170549|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
170550|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
170551|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
170552|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
170553|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
170594|NCT01674621|O4|Outcome|BA058 (Abaloparatide) Transdermal (150 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 150 mcg daily~BA058 Transdermal (150 mcg): BA058 Transdermal Microneedle Active Patch, 150 mcg, daily applications for 6 months"
170595|NCT01674621|O3|Outcome|BA058 (Abaloparatide) Transdermal (100 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 100 mcg daily~BA058 Transdermal (100 mcg): BA058 Transdermal Microneedle Active Patch, 100 mcg, daily applications for 6 months"
183874|NCT01627002|O7|Outcome|Part B PA401 1.0 mg|
170554|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
170555|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
170556|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
170557|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
170558|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
170559|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
170560|NCT01674647|E2|Reported Event|Vitamin K Antagonist|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
170596|NCT01674621|O2|Outcome|BA058 (Abaloparatide) Transdermal (50 mcg)|"BA058 (abaloparatide)Transdermal Microneedle Patch - 50 mcg daily~BA058 Transdermal (50 mcg): BA058 Transdermal Microneedle Active Patch, 50 mcg, daily applications for 6 months"
170597|NCT01674621|O1|Outcome|BA058 (Abaloparatide) Transdermal Placebo (0 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch 0 mcg daily~BA058 Placebo: BA058 Transdermal Microneedle Placebo Patch, 0 mcg, daily applications for 6 months"
170561|NCT01674647|E1|Reported Event|Rivaroxaban (Xarelto; BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
170562|NCT01674634|B1|Baseline|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
170563|NCT01674634|P1|Participant Flow|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
170564|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
170565|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
170566|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
170567|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
170568|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
170569|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
170570|NCT01674634|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|AA4500 (collagenase clostridium histolyticum); 0.58 mg injection in the PIP joint cord
170571|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX MP Joint|AA4500 (collagenase clostridium histolyticum); 0.58 mg injection in the MP joint cord
170572|NCT01674634|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|AA4500 (collagenase clostridium histolyticum); 0.58 mg injection in the proximal interphalangeal (PIP) joint cord
170573|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX MP Joint|AA4500 (collagenase clostridium histolyticum); 0.58 mg injection in the metacarpophalangeal (MP) joint cord
170574|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
170575|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
170576|NCT01674634|E1|Reported Event|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
170577|NCT01674621|B6|Baseline|Total|Total of all reporting groups
170578|NCT01674621|B5|Baseline|BA058 (Abaloparatide) Injection (80 mcg)|"BA058 (abaloparatide-SC) Subcutaneous Injection - 80 mcg daily~BA058 Injection (80 mcg): BA058 Subcutaneous Injection, 80 mcg, daily injections for 6 months"
170579|NCT01674621|B4|Baseline|BA058 (Abaloparatide) Transdermal (150 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 150 mcg daily~BA058 Transdermal (150 mcg): BA058 Transdermal Microneedle Active Patch, 150 mcg, daily applications for 6 months"
170580|NCT01674621|B3|Baseline|BA058 (Abaloparatide) Transdermal (100 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 100 mcg daily~BA058 Transdermal (100 mcg): BA058 Transdermal Microneedle Active Patch, 100 mcg, daily applications for 6 months"
170581|NCT01674621|B2|Baseline|BA058 (Abaloparatide) Transdermal (50 mcg)|"BA058 (abaloparatide)Transdermal Microneedle Patch - 50 mcg daily~BA058 Transdermal (50 mcg): BA058 Transdermal Microneedle Active Patch, 50 mcg, daily applications for 6 months"
170582|NCT01674621|B1|Baseline|BA058 (Abaloparatide) Transdermal Placebo (0 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch 0 mcg daily~BA058 Placebo: BA058 Transdermal Microneedle Placebo Patch, 0 mcg, daily applications for 6 months"
170583|NCT01674621|P5|Participant Flow|BA058 (Abaloparatide) Injection (80 mcg)|"BA058 (abaloparatide-SC) Subcutaneous Injection - 80 mcg daily~BA058 Injection (80 mcg): BA058 Subcutaneous Injection, 80 mcg, daily injections for 6 months"
170584|NCT01674621|P4|Participant Flow|BA058 (Abaloparatide) Transdermal (150 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 150 mcg daily~BA058 Transdermal (150 mcg): BA058 Transdermal Microneedle Active Patch, 150 mcg, daily applications for 6 months"
170585|NCT01674621|P3|Participant Flow|BA058 (Abaloparatide) Transdermal (100 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 100 mcg daily~BA058 Transdermal (100 mcg): BA058 Transdermal Microneedle Active Patch, 100 mcg, daily applications for 6 months"
170586|NCT01674621|P2|Participant Flow|BA058 (Abaloparatide) Transdermal (50 mcg)|"BA058 (abaloparatide)Transdermal Microneedle Patch - 50 mcg daily~BA058 Transdermal (50 mcg): BA058 Transdermal Microneedle Active Patch, 50 mcg, daily applications for 6 months"
170587|NCT01674621|P1|Participant Flow|BA058 (Abaloparatide) Transdermal Placebo (0 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch 0 mcg daily~BA058 Placebo: BA058 Transdermal Microneedle Placebo Patch, 0 mcg, daily applications for 6 months"
170588|NCT01674621|O5|Outcome|BA058 (Abaloparatide) Injection (80 mcg)|"BA058 (abaloparatide-SC) Subcutaneous Injection - 80 mcg daily~BA058 Injection (80 mcg): BA058 Subcutaneous Injection, 80 mcg, daily injections for 6 months"
170589|NCT01674621|O4|Outcome|BA058 (Abaloparatide) Transdermal (150 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 150 mcg daily~BA058 Transdermal (150 mcg): BA058 Transdermal Microneedle Active Patch, 150 mcg, daily applications for 6 months"
170590|NCT01674621|O3|Outcome|BA058 (Abaloparatide) Transdermal (100 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 100 mcg daily~BA058 Transdermal (100 mcg): BA058 Transdermal Microneedle Active Patch, 100 mcg, daily applications for 6 months"
170591|NCT01674621|O2|Outcome|BA058 (Abaloparatide) Transdermal (50 mcg)|"BA058 (abaloparatide)Transdermal Microneedle Patch - 50 mcg daily~BA058 Transdermal (50 mcg): BA058 Transdermal Microneedle Active Patch, 50 mcg, daily applications for 6 months"
177284|NCT01650246|E1|Reported Event|Lesinurad 400 mg|lesinurad 400 mg once daily (qd)
170599|NCT01674621|O4|Outcome|BA058 (Abaloparatide) Transdermal (150 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 150 mcg daily~BA058 Transdermal (150 mcg): BA058 Transdermal Microneedle Active Patch, 150 mcg, daily applications for 6 months"
170600|NCT01674621|O3|Outcome|BA058 (Abaloparatide) Transdermal (100 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 100 mcg daily~BA058 Transdermal (100 mcg): BA058 Transdermal Microneedle Active Patch, 100 mcg, daily applications for 6 months"
170601|NCT01674621|O2|Outcome|BA058 (Abaloparatide) Transdermal (50 mcg)|"BA058 (abaloparatide)Transdermal Microneedle Patch - 50 mcg daily~BA058 Transdermal (50 mcg): BA058 Transdermal Microneedle Active Patch, 50 mcg, daily applications for 6 months"
170602|NCT01674621|O1|Outcome|BA058 (Abaloparatide) Transdermal Placebo (0 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch 0 mcg daily~BA058 Placebo: BA058 Transdermal Microneedle Placebo Patch, 0 mcg, daily applications for 6 months"
170603|NCT01674621|E5|Reported Event|BA058 (Abaloparatide) Injection (80 mcg)|"BA058 (abaloparatide-SC) Subcutaneous Injection - 80 mcg daily~BA058 Injection (80 mcg): BA058 Subcutaneous Injection, 80 mcg, daily injections for 6 months"
170604|NCT01674621|E4|Reported Event|BA058 (Abaloparatide) Transdermal (150 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 150 mcg daily~BA058 Transdermal (150 mcg): BA058 Transdermal Microneedle Active Patch, 150 mcg, daily applications for 6 months"
170605|NCT01674621|E3|Reported Event|BA058 (Abaloparatide) Transdermal (100 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 100 mcg daily~BA058 Transdermal (100 mcg): BA058 Transdermal Microneedle Active Patch, 100 mcg, daily applications for 6 months"
170606|NCT01674621|E2|Reported Event|BA058 (Abaloparatide) Transdermal (50 mcg)|"BA058 (abaloparatide)Transdermal Microneedle Patch - 50 mcg daily~BA058 Transdermal (50 mcg): BA058 Transdermal Microneedle Active Patch, 50 mcg, daily applications for 6 months"
170607|NCT01674621|E1|Reported Event|BA058 (Abaloparatide) Transdermal Placebo (0 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch 0 mcg daily~BA058 Placebo: BA058 Transdermal Microneedle Placebo Patch, 0 mcg, daily applications for 6 months"
170608|NCT01674062|B3|Baseline|Total|Total of all reporting groups
170609|NCT01674062|B2|Baseline|Pertuzumab +/- Trastuzumab (Cohort 3)|Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. Participants with documented disease progression could have trastuzumab added to the regimen, per the dosing schedule described for Cohorts 1 and 2, to receive dual-agent treatment until disease progression, intolerable toxicity, or death.
170610|NCT01674062|B1|Baseline|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
170611|NCT01674062|P2|Participant Flow|Pertuzumab +/- Trastuzumab (Cohort 3)|Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. Participants with documented disease progression could have trastuzumab added to the regimen, per the dosing schedule described for Cohorts 1 and 2, to receive dual-agent treatment until disease progression, intolerable toxicity, or death.
170612|NCT01674062|P1|Participant Flow|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via intravenous (IV) infusion as 2 milligrams per kilogram (mg/kg) once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 milligrams (mg) followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
170613|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
170614|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
170660|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
170909|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170615|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
170616|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
170617|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
170618|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
170619|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
170620|NCT01674062|O1|Outcome|Pertuzumab (Cohort 3)|Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. The treatment regimen was maintained until disease progression, intolerable toxicity, death, and/or transition to dual-agent therapy with trastuzumab.
170621|NCT01674062|O1|Outcome|Pertuzumab (Cohort 3)|Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. The treatment regimen was maintained until disease progression, intolerable toxicity, death, and/or transition to dual-agent therapy with trastuzumab.
170622|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
170623|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
170624|NCT01674062|E2|Reported Event|Pertuzumab +/- Trastuzumab (Cohort 3)|Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. Participants with documented disease progression could have trastuzumab added to the regimen, per the dosing schedule described for Cohorts 1 and 2, to receive dual-agent treatment until disease progression, intolerable toxicity, or death.
170661|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
170960|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
170625|NCT01674062|E1|Reported Event|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
170626|NCT01674010|B1|Baseline|All Study Participants|
170627|NCT01674010|P3|Participant Flow|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
170628|NCT01674010|P2|Participant Flow|Phase 2 Placebo|Double Blind Randomization (Phase 2)
170629|NCT01674010|P1|Participant Flow|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
170630|NCT01674010|O3|Outcome|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
170631|NCT01674010|O2|Outcome|Phase 2 Placebo|Double Blind Randomization (Phase 2)
170632|NCT01674010|O1|Outcome|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
170633|NCT01674010|O3|Outcome|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
170634|NCT01674010|O2|Outcome|Phase 2 Placebo|Double Blind Randomization (Phase 2)
170635|NCT01674010|O1|Outcome|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
170636|NCT01674010|O3|Outcome|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
170637|NCT01674010|O2|Outcome|Phase 2 Placebo|Double Blind Randomization (Phase 2)
170638|NCT01674010|O1|Outcome|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
170639|NCT01674010|O3|Outcome|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
170640|NCT01674010|O2|Outcome|Phase 2 Placebo|Double Blind Randomization (Phase 2)
170641|NCT01674010|O1|Outcome|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
170642|NCT01674010|E3|Reported Event|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
170643|NCT01674010|E2|Reported Event|Phase 2 Placebo|Double Blind Randomization (Phase 2)
170644|NCT01674010|E1|Reported Event|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
170645|NCT01673984|B3|Baseline|Total|Total of all reporting groups
170646|NCT01673984|B2|Baseline|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
170647|NCT01673984|B1|Baseline|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
170648|NCT01673984|P2|Participant Flow|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
170649|NCT01673984|P1|Participant Flow|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
170650|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
170651|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
170652|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
170653|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
170654|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
170655|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
170656|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
170657|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
170658|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
170659|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
170752|NCT01673620|P2|Participant Flow|Placebo|Participants receive matching placebo tablets once daily for 2 weeks
170662|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
170663|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
170664|NCT01673984|E2|Reported Event|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
170665|NCT01673984|E1|Reported Event|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
170666|NCT01673919|B1|Baseline|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
170667|NCT01673919|P1|Participant Flow|Tocilizumab (8 mg/kg)|Eligible participants received tocilizumab (TCZ) 8 milligram/kilogram (mg/kg) intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) in France, whichever came first.
170668|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
170669|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
170670|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
170671|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
170672|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
170673|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
170674|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
170675|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
170676|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
170677|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
170678|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
170679|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
170680|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
170681|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
170682|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
170683|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
170684|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
170685|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
170686|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
170687|NCT01673919|E1|Reported Event|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
170688|NCT01673867|B3|Baseline|Total|Total of all reporting groups
170689|NCT01673867|B2|Baseline|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170690|NCT01673867|B1|Baseline|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170691|NCT01673867|P2|Participant Flow|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170692|NCT01673867|P1|Participant Flow|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170693|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170694|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170695|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170696|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170697|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170698|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170699|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170700|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170701|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170702|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170703|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170704|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170705|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170706|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170707|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170708|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170709|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
177285|NCT01649856|B3|Baseline|Total|Total of all reporting groups
170710|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170711|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170712|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170713|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170714|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170715|NCT01673867|E2|Reported Event|NIVOLUMAB 3 mg/kg|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170716|NCT01673867|E1|Reported Event|DOCETAXEL|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
170717|NCT01673854|B1|Baseline|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity.
170718|NCT01673854|P1|Participant Flow|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity.
170719|NCT01673854|O1|Outcome|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity. Following the end-of-treatment visit, patients entered the Follow-up Phase.
170720|NCT01673854|O1|Outcome|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity. Following the end-of-treatment visit, patients entered the Follow-up Phase.
170721|NCT01673854|O1|Outcome|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity. Following the end-of-treatment visit, patients entered the Follow-up Phase.
170722|NCT01673854|O1|Outcome|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity. Following the end-of-treatment visit, patients entered the Follow-up Phase.
170723|NCT01673854|O1|Outcome|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity. Following the end-of-treatment visit, patients entered the Follow-up Phase.
170852|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170724|NCT01673854|E1|Reported Event|Vemurafenib, 960 mg + Ipilimumab,10 mg/kg ab|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity.
170725|NCT01673828|B3|Baseline|Total|Total of all reporting groups
170726|NCT01673828|B2|Baseline|Placebo|"Placebo injection (intravenous solution) continuous infusion for 5 days~Placebo injection: Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium"
170727|NCT01673828|B1|Baseline|Allopregnanolone|"Allopregnanolone injection (intravenous solution) continuous infusion for 5 days~Allopregnanolone injection: Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium"
170728|NCT01673828|P2|Participant Flow|Placebo|"Placebo injection (intravenous solution) continuous infusion for 5 days~Placebo injection: Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium"
170729|NCT01673828|P1|Participant Flow|Allopregnanolone|"Allopregnanolone injection (intravenous solution) continuous infusion for 5 days~Allopregnanolone injection: Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium"
170730|NCT01673828|O2|Outcome|Placebo|"Placebo injection (intravenous solution) continuous infusion for 5 days~Placebo injection: Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium"
170731|NCT01673828|O1|Outcome|Allopregnanolone|"Allopregnanolone injection (intravenous solution) continuous infusion for 5 days~Allopregnanolone injection: Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium"
170732|NCT01673828|E2|Reported Event|Placebo|"Placebo injection (intravenous solution) continuous infusion for 5 days~Placebo injection: Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium"
170733|NCT01673828|E1|Reported Event|Allopregnanolone|"Allopregnanolone injection (intravenous solution) continuous infusion for 5 days~Allopregnanolone injection: Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium"
170734|NCT01673802|B1|Baseline|Gadoxetate Uptake in CT Imaging|Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.
170735|NCT01673802|P1|Participant Flow|Gadoxetate Uptake in CT Imaging|Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.
170736|NCT01673802|O1|Outcome|Gadoxetate Uptake in CT Imaging|Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.
170737|NCT01673802|E1|Reported Event|Gadoxetate Uptake in CT Imaging|Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.
170738|NCT01673698|B3|Baseline|Total|Total of all reporting groups
170739|NCT01673698|B2|Baseline|Sham Comparator|"Sham Comparator~Diet counseling~Exercise counseling"
170740|NCT01673698|B1|Baseline|ReShape Duo Balloon|"ReShape Duo Balloon~ReShape Duo balloon~Diet counseling~Exercise counseling"
170741|NCT01673698|P2|Participant Flow|Sham Comparator|"Sham Comparator~Diet counseling~Exercise counseling"
170742|NCT01673698|P1|Participant Flow|ReShape Duo Balloon|"ReShape Duo Balloon~ReShape Duo balloon~Diet counseling~Exercise counseling"
170743|NCT01673698|O1|Outcome|Intent-to-Treat|Intent-to-Treat population
170744|NCT01673698|O1|Outcome|Intent-to-Treat|Intent-to-Treat population
170745|NCT01673698|O2|Outcome|Control|Control group
170746|NCT01673698|O1|Outcome|Treatment|Treatment group
170747|NCT01673698|E2|Reported Event|Control Subjects|Subjects who were randomized to diet and exercise counseling only during weeks 0-24
170748|NCT01673698|E1|Reported Event|Treatment Subjects|Subjects who were randomized and received a balloon during weeks 0-24
170749|NCT01673620|B3|Baseline|Total|Total of all reporting groups
170750|NCT01673620|B2|Baseline|Placebo|Participants receive matching placebo tablets once daily for 2 weeks
170751|NCT01673620|B1|Baseline|Montelukast 10 mg/Loratadine 10 mg|Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks
183875|NCT01627002|O6|Outcome|Part A Placebo|
170753|NCT01673620|P1|Participant Flow|Montelukast 10 mg/Loratadine 10 mg|Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks
170754|NCT01673620|O2|Outcome|Placebo|Participants receive matching placebo tablets once daily for 2 weeks
170755|NCT01673620|O1|Outcome|Montelukast 10 mg/Loratadine 10 mg|Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks
170756|NCT01673620|O2|Outcome|Placebo|Participants receive matching placebo tablets once daily for 2 weeks
170757|NCT01673620|O1|Outcome|Montelukast 10 mg/Loratadine 10 mg|Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks
170758|NCT01673620|E2|Reported Event|Placebo|Participants receive matching placebo tablets once daily for 2 weeks
170759|NCT01673620|E1|Reported Event|Montelukast 10 mg/Loratadine 10 mg|Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks
170760|NCT01673594|B3|Baseline|Total|Total of all reporting groups
170761|NCT01673594|B2|Baseline|Placebo|"Arm 2: Placebo + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH"
170762|NCT01673594|B1|Baseline|Naltrexone|"Arm 1: Naltrexone + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH~Naltrexone: Subjects randomized to the active double-blind group will receive Naltrexone HCl"
170763|NCT01673594|P2|Participant Flow|Placebo|"Arm 2: Placebo + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH"
170764|NCT01673594|P1|Participant Flow|Naltrexone|"Arm 1: Naltrexone + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH~Naltrexone: Subjects randomized to the active double-blind group will receive Naltrexone HCl"
170765|NCT01673594|O2|Outcome|Placebo|"Arm 2: Placebo + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH"
170766|NCT01673594|O1|Outcome|Naltrexone|"Arm 1: Naltrexone + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH~Naltrexone: Subjects randomized to the active double-blind group will receive Naltrexone HCl"
170767|NCT01673594|O2|Outcome|Placebo|"Arm 2: Placebo + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH"
170768|NCT01673594|O1|Outcome|Naltrexone|"Arm 1: Naltrexone + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH~Naltrexone: Subjects randomized to the active double-blind group will receive Naltrexone HCl"
170769|NCT01673594|E2|Reported Event|Placebo|"Arm 2: Placebo + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH"
170770|NCT01673594|E1|Reported Event|Naltrexone|"Arm 1: Naltrexone + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH~Naltrexone: Subjects randomized to the active double-blind group will receive Naltrexone HCl"
170771|NCT01673568|B3|Baseline|Total|Total of all reporting groups
170772|NCT01673568|B2|Baseline|no Abdominal Binder|no abdominal binder was warn
170773|NCT01673568|B1|Baseline|Abdominal Binder|"The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.~ETO garments: patients wearing abdominal binder for 7 days postoperatively"
170774|NCT01673568|P2|Participant Flow|no Abdominal Binder|no abdominal binder
170775|NCT01673568|P1|Participant Flow|Abdominal Binder|"The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.~ETO garments: patients wearing abdominal binder for 7 days postoperatively"
170776|NCT01673568|O2|Outcome|no Abdominal Binder|no abdominal binder
170777|NCT01673568|O1|Outcome|Abdominal Binder|"The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.~ETO garments: patients wearing abdominal binder for 7 days postoperatively"
170778|NCT01673568|O2|Outcome|no Abdominal Binder|no abdominal binder
170779|NCT01673568|O1|Outcome|Abdominal Binder|"The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.~ETO garments: patients wearing abdominal binder for 7 days postoperatively"
170780|NCT01673568|E2|Reported Event|no Abdominal Binder|no abdominal binder
170781|NCT01673568|E1|Reported Event|Abdominal Binder|"The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.~ETO garments: patients wearing abdominal binder for 7 days postoperatively"
170782|NCT01673490|B1|Baseline|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
170783|NCT01673490|P1|Participant Flow|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
170784|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
170785|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
170786|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
170787|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
170788|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
170789|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
170790|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
170791|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
170792|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
170793|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
170794|NCT01673490|E1|Reported Event|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
170795|NCT01673425|B1|Baseline|Live Attenuated Influenza Vaccine Study|This study was terminated due to poor enrollment and inconclusive nasal wash samples. No analyses were performed.
170796|NCT01673425|P1|Participant Flow|Experimental: Live Attenuated Influenza Vaccine|Single intervention study; all participants receive LAIV
170797|NCT01673425|O1|Outcome|Experimental: Live Attenuated Influenza Vaccine|Single Intervention Study
170798|NCT01673425|E1|Reported Event|Study Enrollment|Low accrual. Only 4 subjects completed study in 2 month period. Study terminated.
170799|NCT01673347|B1|Baseline|MENISCAL ALLOGRAFT|"The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe.~Meniscal Allograft: Meniscal allograft"
170800|NCT01673347|P1|Participant Flow|MENISCAL ALLOGRAFT|"The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe.~Meniscal Allograft: Meniscal allograft"
170801|NCT01673347|O1|Outcome|MENISCAL ALLOGRAFT|The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe for treatment of metatarsophalangeal (MTP) osteoarthritis.
170802|NCT01673347|O1|Outcome|MENISCAL ALLOGRAFT|The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe for treatment of metatarsophalangeal (MTP) osteoarthritis.
170803|NCT01673347|O1|Outcome|MENISCAL ALLOGRAFT|The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe for treatment of metatarsophalangeal (MTP) osteoarthritis.
170804|NCT01673347|O1|Outcome|MENISCAL ALLOGRAFT|The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe for treatment of metatarsophalangeal (MTP) osteoarthritis.
170805|NCT01673347|E1|Reported Event|MENISCAL ALLOGRAFT|"The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe.~Meniscal Allograft: Meniscal allograft"
170806|NCT01673282|B3|Baseline|Total Title|
170807|NCT01673282|B2|Baseline|Vimpat + Non-Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
170808|NCT01673282|B1|Baseline|Vimpat + Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
170809|NCT01673282|P2|Participant Flow|Vimpat + Non-Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
170810|NCT01673282|P1|Participant Flow|Vimpat + Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
170811|NCT01673282|O2|Outcome|Vimpat + Non-Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
170853|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170812|NCT01673282|O1|Outcome|Vimpat + Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
170813|NCT01673282|E2|Reported Event|Vimpat + Non-Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
170814|NCT01673282|E1|Reported Event|Vimpat + Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
170815|NCT01673256|B1|Baseline|SJM Confirm ICM Observational Group|SJM Confirm ICM
170816|NCT01673256|P1|Participant Flow|SJM Confirm ICM Observational Group|SJM Confirm ICM
170817|NCT01673256|O1|Outcome|SJM Confirm ICM Observational Group|SJM Confirm ICM
170818|NCT01673256|E1|Reported Event|SJM Confirm ICM Observational Group|SJM Confirm ICM
170819|NCT01673191|B3|Baseline|Total|Total of all reporting groups
170820|NCT01673191|B2|Baseline|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
170821|NCT01673191|B1|Baseline|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
170822|NCT01673191|P2|Participant Flow|Steroid Plus NSAID Eye Drop Combination Therapy|"NSAID eye drop: Acular LS Steriod eye drop: Pred Forte~Steroid plus NSAID eye drop combination therapy"
170823|NCT01673191|P1|Participant Flow|OZURDEX Intraocular Implant|"OZURDEX (dexamethasone posterior segment drug delivery system (DEX PS DDS), 0.7 mg~Dexamethasone intravitreal implant"
170824|NCT01673191|O2|Outcome|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
170825|NCT01673191|O1|Outcome|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
170826|NCT01673191|O2|Outcome|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
170827|NCT01673191|O1|Outcome|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
170828|NCT01673191|O2|Outcome|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
170829|NCT01673191|O1|Outcome|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
170830|NCT01673191|O2|Outcome|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
170854|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170855|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170856|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170857|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170831|NCT01673191|O1|Outcome|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
170832|NCT01673191|O2|Outcome|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
170833|NCT01673191|O1|Outcome|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
170834|NCT01673191|O2|Outcome|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
170835|NCT01673191|O1|Outcome|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
170836|NCT01673191|O2|Outcome|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
170837|NCT01673191|O1|Outcome|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
170838|NCT01673191|E2|Reported Event|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
170839|NCT01673191|E1|Reported Event|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
170840|NCT01673178|B6|Baseline|Total|Total of all reporting groups
170841|NCT01673178|B5|Baseline|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170842|NCT01673178|B4|Baseline|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170843|NCT01673178|B3|Baseline|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170844|NCT01673178|B2|Baseline|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170845|NCT01673178|B1|Baseline|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
170846|NCT01673178|P5|Participant Flow|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170847|NCT01673178|P4|Participant Flow|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170848|NCT01673178|P3|Participant Flow|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170849|NCT01673178|P2|Participant Flow|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170850|NCT01673178|P1|Participant Flow|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
170851|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
183876|NCT01627002|O5|Outcome|Part A PA401 10 mg|
170858|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170859|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170860|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170861|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170862|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170863|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170864|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170865|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170866|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170867|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170868|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170869|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170870|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170871|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170872|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170873|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170874|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170875|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170876|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170877|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170878|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170879|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170880|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170881|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170882|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170883|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170884|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170885|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170886|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170887|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170888|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170889|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170890|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170891|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170892|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170893|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170894|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170895|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170896|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170897|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170898|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170899|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170900|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170901|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170902|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170903|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170904|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170905|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170906|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170907|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170908|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170910|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170911|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170912|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170913|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170914|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170915|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
170916|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170917|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170918|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170919|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170920|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
170921|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170922|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170923|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170924|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170925|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
170926|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170927|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170928|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170929|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170930|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
170931|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170932|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170933|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170934|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170935|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
170936|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170937|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170938|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170939|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170940|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
170941|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170942|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170943|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170944|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170945|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
170946|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170947|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170948|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170949|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170950|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
170951|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170952|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170953|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170954|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170955|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
170956|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170957|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170958|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170959|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
183877|NCT01627002|O4|Outcome|Part A PA401 3.0 mg|
170961|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170962|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170963|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170964|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170965|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
170966|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170967|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170968|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170969|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170970|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
170971|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170972|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170973|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170974|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170975|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
170976|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170977|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170978|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170979|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170980|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
170981|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170982|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170983|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170984|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170985|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
170986|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170987|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170988|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170989|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170990|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
170991|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170992|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170993|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170994|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
170995|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
170996|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170997|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170998|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
170999|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
171000|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
171001|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171002|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171003|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171004|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
171005|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
171006|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171007|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171008|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171009|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
171010|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
183878|NCT01627002|O3|Outcome|Part A PA401 1.0 mg|
171011|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171012|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171013|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171014|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
171015|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
171016|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171017|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171018|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171019|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
171020|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
171021|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171022|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171023|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171024|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
171025|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
171026|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171027|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171028|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171029|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
171030|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
171031|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171032|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171033|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171034|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
171035|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
171036|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171037|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171038|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171039|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
171040|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
171041|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171042|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171043|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171044|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
171045|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
171046|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171047|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171048|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171049|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
171050|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
171051|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171052|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171053|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171054|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
171055|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
171056|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171057|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171058|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171059|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
171060|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
183879|NCT01627002|O2|Outcome|Part A PA401 0.3 mg|
171061|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171062|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171063|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171064|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
171065|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
171066|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171067|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171068|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171069|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
171070|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
171071|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171072|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171073|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171074|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
171075|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
171076|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171077|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171078|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171079|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
171080|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
171081|NCT01673178|E5|Reported Event|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171082|NCT01673178|E4|Reported Event|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171083|NCT01673178|E3|Reported Event|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
171084|NCT01673178|E2|Reported Event|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
171085|NCT01673178|E1|Reported Event|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
171086|NCT01673126|B3|Baseline|Total|Total of all reporting groups
171087|NCT01673126|B2|Baseline|Sham tDCS First|Patients received sham tDCS during 20 minutes. Then, washout of 2days. Then andoal tDCS.
171088|NCT01673126|B1|Baseline|Anodal tDCS First|Patients received anodal tDCS during 20 minutes. Then, washout of 2days. Then sham tDCS.
171089|NCT01673126|P2|Participant Flow|Sham tDCS|Sham tDCS during first, then 2 days of washout, then anodal tDCS.
171090|NCT01673126|P1|Participant Flow|Anodal tDCS|Anodal tDCS (on DLPF cortex) first, hen 2 days of washout, then sham tDCS.
171091|NCT01673126|O2|Outcome|Sham tDCS First|"Patients received sham tDCS first during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised).~Then, a washout period (2days). Then anodal tDCS during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised)."
171092|NCT01673126|O1|Outcome|Anodal tDCS First|"Patients received anodal tDCS first during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised).~Then, a washout period (2days). Then sham tDCS during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised)."
171093|NCT01673126|E2|Reported Event|Sham tDCS|"Patient received a sham tDCS (5sec of stimulation). The device runs during 20minutes and the anode was placed over the DLPF cortex. A behavioral assessment preceded and followed the stimulation.~sham tDCS: Patient received a sham tDCS (5sec of stimulation). The device runs during 20minutes and the anode was placed over the DLPF cortex. A behavioral assessment preceded and followed the stimulation."
171094|NCT01673126|E1|Reported Event|Anodal tDCS|"Patients received anodal tDCS (on DLPF cortex) during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised)~Anodal tDCS: patients received anodal tDCS (on PFDL cortex) during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised)"
171095|NCT01673113|B3|Baseline|Total|Total of all reporting groups
171096|NCT01673113|B2|Baseline|Control|The untreated flank of each subject served as the internal control.
171097|NCT01673113|B1|Baseline|Treatment|Subjects were randomized to have right or left flank treated with Zeltiq CoolSculpting device
171098|NCT01673113|P2|Participant Flow|Control|The untreated flank of each subject served as internal control.
171099|NCT01673113|P1|Participant Flow|Treatment|Subjects were randomized to have either left or right flank treated with cryolipolysis.
171100|NCT01673113|O2|Outcome|Control|The untreated flank of each subject served as the internal control.
171101|NCT01673113|O1|Outcome|Treatment|Subjects were randomized to have right or left flank treated with Zeltiq CoolSculpting device
171102|NCT01673113|O2|Outcome|Control|Untreated flanks of each subject had vibration sensory testing done within 48-72 hours after treatment.
171103|NCT01673113|O1|Outcome|Treatment|Cryolipolysis treated flanks had vibration sensory testing done within 48-72 hours after treatment.
171104|NCT01673113|E1|Reported Event|Cryolipolysis|Zeltiq CoolSculpting device: This is an FDA approved cooling device used for non-invasive and selective reduction of fat around the flanks, an area commonly referred to as the “love handles.”
171184|NCT01672983|E6|Reported Event|Arm 6|Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
171105|NCT01673009|B1|Baseline|Administration of Gleevec|"Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.~Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients."
171106|NCT01673009|P1|Participant Flow|Administration of Gleevec|"Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.~Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients."
171107|NCT01673009|O1|Outcome|Administration of Gleevec|"Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.~Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients."
171108|NCT01673009|O1|Outcome|Administration of Gleevec|"Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.~Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients."
171109|NCT01673009|E1|Reported Event|Administration of Gleevec|"Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.~Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients."
171110|NCT01672996|B8|Baseline|Total|Total of all reporting groups
171111|NCT01672996|B7|Baseline|Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg|"Iopamidol 300 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
171112|NCT01672996|B6|Baseline|Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 2.0mL/Kg"
171113|NCT01672996|B5|Baseline|Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.5mL/Kg"
171114|NCT01672996|B4|Baseline|Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
171115|NCT01672996|B3|Baseline|Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 2.0mL/kg."
171116|NCT01672996|B2|Baseline|Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.5mL/kg."
171117|NCT01672996|B1|Baseline|Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.0mL/kg."
171118|NCT01672996|P3|Participant Flow|Arm 3 - Iopamidol 300mgI/mL|"Given as a single administration to the subject~Iopamidol 300 mgI/mL: Given as a single administration to the subject"
171119|NCT01672996|P2|Participant Flow|Arm 2 - Ioforminol 200mgI/mL|"Given as a single administration to the subject~Ioforminol 200 mgI/mL: Given as a single administration to the subject"
171120|NCT01672996|P1|Participant Flow|Arm 1 - Ioforminol 160mgI/mL|"Single administration of Ioforminol 160mgI/mL given to the subject.~Ioforminol 160 mgI/mL: Given as s single administration to the subject"
171121|NCT01672996|O7|Outcome|Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg|"Iopamidol 300 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
171122|NCT01672996|O6|Outcome|Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 2.0mL/Kg"
171123|NCT01672996|O5|Outcome|Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.5mL/Kg"
171124|NCT01672996|O4|Outcome|Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
171125|NCT01672996|O3|Outcome|Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 2.0mL/kg."
171126|NCT01672996|O2|Outcome|Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.5mL/kg."
171127|NCT01672996|O1|Outcome|Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.0mL/kg."
171128|NCT01672996|O7|Outcome|Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg|"Iopamidol 300 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
171129|NCT01672996|O6|Outcome|Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 2.0mL/Kg"
171130|NCT01672996|O5|Outcome|Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.5mL/Kg"
171131|NCT01672996|O4|Outcome|Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
171132|NCT01672996|O3|Outcome|Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 2.0mL/kg."
171133|NCT01672996|O2|Outcome|Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.5mL/kg."
171134|NCT01672996|O1|Outcome|Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.0mL/kg."
171135|NCT01672996|O7|Outcome|Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg|"Iopamidol 300 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
171136|NCT01672996|O6|Outcome|Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 2.0mL/Kg"
171137|NCT01672996|O5|Outcome|Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.5mL/Kg"
171138|NCT01672996|O4|Outcome|Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
171139|NCT01672996|O3|Outcome|Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 2.0mL/kg."
171140|NCT01672996|O2|Outcome|Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.5mL/kg."
171141|NCT01672996|O1|Outcome|Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.0mL/kg."
171142|NCT01672996|E7|Reported Event|Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg|"Iopamidol 300 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
171143|NCT01672996|E6|Reported Event|Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 2.0mL/Kg"
171144|NCT01672996|E5|Reported Event|Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.5mL/Kg"
171145|NCT01672996|E4|Reported Event|Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
171146|NCT01672996|E3|Reported Event|Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 2.0mL/kg."
171147|NCT01672996|E2|Reported Event|Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.5mL/kg."
171148|NCT01672996|E1|Reported Event|Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.0mL/kg."
171149|NCT01672983|B7|Baseline|Total|Total of all reporting groups
171150|NCT01672983|B6|Baseline|Arm 6|Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
171151|NCT01672983|B5|Baseline|Arm 5|Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
171152|NCT01672983|B4|Baseline|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
171153|NCT01672983|B3|Baseline|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
171154|NCT01672983|B2|Baseline|Arm 2|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
171155|NCT01672983|B1|Baseline|Arm 1|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
171156|NCT01672983|P6|Participant Flow|Arm 6|Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
171157|NCT01672983|P5|Participant Flow|Arm 5|Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
171158|NCT01672983|P4|Participant Flow|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
171159|NCT01672983|P3|Participant Flow|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
171160|NCT01672983|P2|Participant Flow|Arm 2|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
171161|NCT01672983|P1|Participant Flow|Arm 1|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
171162|NCT01672983|O6|Outcome|Arm 6|Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
171163|NCT01672983|O5|Outcome|Arm 5|Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
171164|NCT01672983|O4|Outcome|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
171165|NCT01672983|O3|Outcome|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
171166|NCT01672983|O2|Outcome|Arm 2|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
171167|NCT01672983|O1|Outcome|Arm 1|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
171168|NCT01672983|O6|Outcome|Arm 6|Hepatitis C Virus (HCV), genotype 2 (GT2) participants received 150/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.
171169|NCT01672983|O5|Outcome|Arm 5|Hepatitis C Virus (HCV), genotype 2 (GT2) participants received 100/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.
171170|NCT01672983|O4|Outcome|Arm 4|Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 150/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 24 weeks.
171171|NCT01672983|O3|Outcome|Arm 3|Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 100/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 24 weeks.
171172|NCT01672983|O2|Outcome|Arm 2|Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 150/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.
171173|NCT01672983|O1|Outcome|Arm 1|Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 100/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.
171174|NCT01672983|O4|Outcome|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
171175|NCT01672983|O3|Outcome|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
171176|NCT01672983|O2|Outcome|Arm 2 + Arm 6|Arm 2: Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks; Arm 6: Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
171177|NCT01672983|O1|Outcome|Arm 1 + Arm 5|Arm 1: Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks; Arm 5: Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
171178|NCT01672983|O6|Outcome|Arm 6|Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
171179|NCT01672983|O5|Outcome|Arm 5|Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
171180|NCT01672983|O4|Outcome|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
171181|NCT01672983|O3|Outcome|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
171182|NCT01672983|O2|Outcome|Arm 2|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
171183|NCT01672983|O1|Outcome|Arm 1|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
171185|NCT01672983|E5|Reported Event|Arm 5|Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
171186|NCT01672983|E4|Reported Event|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
171187|NCT01672983|E3|Reported Event|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
171188|NCT01672983|E2|Reported Event|Arm 2|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
171189|NCT01672983|E1|Reported Event|Arm 1|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
171190|NCT01672970|B1|Baseline|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171191|NCT01672970|P1|Participant Flow|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria, in whom the attending physician decided to start treatment with tocilizumab (TCZ) (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171192|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171193|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171194|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171195|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171196|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171197|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171198|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171199|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171200|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171201|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171202|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171203|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171204|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171205|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171206|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171207|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171208|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171209|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171288|NCT01672788|O3|Outcome|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
171210|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171211|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171212|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171213|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171214|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171215|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171216|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171217|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171218|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171219|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171220|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171221|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171222|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171223|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171224|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171225|NCT01672970|E1|Reported Event|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
171226|NCT01672957|B1|Baseline|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
171227|NCT01672957|P1|Participant Flow|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil (CellCept), were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and Summary of Product Characteristics (SmPC). The study protocol did not specify any treatment regimen.
171228|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
171229|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
171230|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
171231|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
171232|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
171233|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
171234|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
171235|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
171236|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
171237|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
171238|NCT01672957|E1|Reported Event|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
171239|NCT01672892|B3|Baseline|Total|Total of all reporting groups
171240|NCT01672892|B2|Baseline|Standard Radiation Therapy|Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
171241|NCT01672892|B1|Baseline|Intensity-Modulated Radiation Therapy|Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy
171242|NCT01672892|P2|Participant Flow|Standard Radiation Therapy|Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
171243|NCT01672892|P1|Participant Flow|Intensity-Modulated Radiation Therapy|Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy
171244|NCT01672892|O2|Outcome|Standard Radiation Therapy|Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
171245|NCT01672892|O1|Outcome|Intensity-Modulated Radiation Therapy|Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy
171246|NCT01672892|O2|Outcome|Standard Radiation Therapy|Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
171247|NCT01672892|O1|Outcome|Intensity-Modulated Radiation Therapy|Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy
171248|NCT01672892|O2|Outcome|Standard Radiation Therapy|Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
171249|NCT01672892|O1|Outcome|Intensity-Modulated Radiation Therapy|Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy
171250|NCT01672892|O2|Outcome|Standard Radiation Therapy|Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
171251|NCT01672892|O1|Outcome|Intensity-Modulated Radiation Therapy|Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy
171252|NCT01672892|O2|Outcome|Standard Radiation Therapy|Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
171253|NCT01672892|O1|Outcome|Intensity-Modulated Radiation Therapy|Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy
171254|NCT01672892|E2|Reported Event|Standard Radiation Therapy|Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
171255|NCT01672892|E1|Reported Event|Intensity-Modulated Radiation Therapy|Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy
171256|NCT01672827|B1|Baseline|[18F]Flutemetamol|No subjects were dosed for this study. Product was used in scans previously acquired in various GE-067 studies. This study was designed to evaluate the effectiveness of an electronic training program for orienting and interpreting Flutemetamol Positive Emission Tomography (PET) Images.
171257|NCT01672827|P1|Participant Flow|[18F]Flutemetamol|No subjects were dosed for this study. Product was used in scans previously acquired in various GE-067 studies. This study was designed to show the PET Image Interpretations among investigators. The study did not enroll the blinded image Readers.
171258|NCT01672827|O1|Outcome|Specificity %|Specificity of the blinded visual PET Image Interpretations without Anatomic Images.
171259|NCT01672827|O1|Outcome|Inter-Reader Agreement|Statistical analysis of Inter-Reader Agreement of PET Images without anatomic Images.
171260|NCT01672827|O1|Outcome|Sensitivity %|Sensitivity of the blinded visual PET Image Interpretations without Anatomic Images.
171261|NCT01672827|E1|Reported Event|[18F]Flutemetamol|No adverse event data collected because no subjects were dosed in this study , therefore no subjects were at risk.
171262|NCT01672788|B1|Baseline|Overall Study|Total number of patients randomised and treated in the study. This was an open-label, randomized, 4-way crossover trial. 36 patients were randomised to one of 4 treatment sequences and treated. Each treatment period consisted of a single dose of medication followed by 72hours of pharmacokinetic sampling, with a washout of at least 7 days between treatment periods.
171263|NCT01672788|P4|Participant Flow|R2 / T2 / R1 / T1|"Patients received the 4 treatments in the following order:~Empa 5mg Free Dose: Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet) (R2)~Empa 5mg Fixed-dose: Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin (T2)~Empa 12.5mg Free Dose: Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet) (R1)~Empa 12.5mg Fixed-dose: Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin (T1)"
171264|NCT01672788|P3|Participant Flow|T2 / R2 / T1 / R1|"Patients received the 4 treatments in the following order:~Empa 5mg Fixed-dose: Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin (T2)~Empa 5mg Free Dose: Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet) (R2)~Empa 12.5mg Fixed-dose: Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin (T1)~Empa 12.5mg Free Dose: Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet) (R1)"
171265|NCT01672788|P2|Participant Flow|R1 / T1 / R2 / T2|"Patients received the 4 treatments in the following order:~Empa 12.5mg Free Dose: Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet) (R1)~Empa 12.5mg Fixed-dose: Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin (T1)~Empa 5mg Free Dose: Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet) (R2)~Empa 5mg Fixed-dose: Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin (T2)"
171266|NCT01672788|P1|Participant Flow|T1 / R1 / T2 / R2|"Patients received the 4 treatments in the following order:~Empa 12.5mg Fixed-dose: Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin (T1)~Empa 12.5mg Free Dose: Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet) (R1)~Empa 5mg Fixed-dose: Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin (T2)~Empa 5mg Free Dose: Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet) (R2)"
171267|NCT01672788|O4|Outcome|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
171268|NCT01672788|O3|Outcome|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
171269|NCT01672788|O2|Outcome|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
171270|NCT01672788|O1|Outcome|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
171271|NCT01672788|O4|Outcome|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
171272|NCT01672788|O3|Outcome|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
171273|NCT01672788|O2|Outcome|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
171274|NCT01672788|O1|Outcome|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
171275|NCT01672788|O4|Outcome|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
171276|NCT01672788|O3|Outcome|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
171277|NCT01672788|O2|Outcome|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
171278|NCT01672788|O1|Outcome|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
171279|NCT01672788|O4|Outcome|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
171280|NCT01672788|O3|Outcome|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
171281|NCT01672788|O2|Outcome|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
171282|NCT01672788|O1|Outcome|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
171283|NCT01672788|O4|Outcome|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
171284|NCT01672788|O3|Outcome|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
171285|NCT01672788|O2|Outcome|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
171286|NCT01672788|O1|Outcome|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
171287|NCT01672788|O4|Outcome|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
171289|NCT01672788|O2|Outcome|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
171290|NCT01672788|O1|Outcome|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
171291|NCT01672788|E4|Reported Event|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
171292|NCT01672788|E3|Reported Event|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
171293|NCT01672788|E2|Reported Event|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
171294|NCT01672788|E1|Reported Event|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
171295|NCT01672723|B1|Baseline|Naltrexone First and Placebo First|Includes groups randomized to receive naltrexone first and placebo first.
171296|NCT01672723|P2|Participant Flow|Placebo First, Then Naltrexone|Participants took 4 placebo pills over 4 days (one pill a day), followed by a 10-day washout period, followed by 4 naltrexone pills for 4 days (25 mg on days 1 and 2, 50mg on days 3 and 4)
171297|NCT01672723|P1|Participant Flow|Naltrexone First, Then Placebo|Participants took 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) followed by a 10-day washout period and finally, 4 matched placebo pills for another 4 days.
171298|NCT01672723|O2|Outcome|Placebo|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure."
171299|NCT01672723|O1|Outcome|Naltrexone|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.~Naltrexone"
171300|NCT01672723|O2|Outcome|Placebo|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure."
171301|NCT01672723|O1|Outcome|Naltrexone|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.~Naltrexone"
171302|NCT01672723|O2|Outcome|Placebo|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure."
171303|NCT01672723|O1|Outcome|Naltrexone|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.~Naltrexone"
171304|NCT01672723|E2|Reported Event|Placebo|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure."
171305|NCT01672723|E1|Reported Event|Naltrexone|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure."
171306|NCT01672658|B3|Baseline|Total|Total of all reporting groups
171307|NCT01672658|B2|Baseline|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
171360|NCT01672242|P1|Participant Flow|HFNC-CPAP|High flow nasal cannula oxygen first period, followed by continuous positive airway pressure second period.
171308|NCT01672658|B1|Baseline|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
171309|NCT01672658|P2|Participant Flow|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
171310|NCT01672658|P1|Participant Flow|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
171311|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
171312|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
171313|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
171314|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
171315|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
171316|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
171317|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
171318|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
171319|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
171320|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
171321|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
171322|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
171323|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
171324|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
171325|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
171361|NCT01672242|O2|Outcome|CPAP|Continuous positive airway pressure 20 cm H2O
171326|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
171327|NCT01672658|E2|Reported Event|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
171328|NCT01672658|E1|Reported Event|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
171329|NCT01672294|B5|Baseline|Total|Total of all reporting groups
171330|NCT01672294|B4|Baseline|Relaxation Meditation - Patient|Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD..
171331|NCT01672294|B3|Baseline|Relaxation Meditation - Caregiver|Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.
171332|NCT01672294|B2|Baseline|Caregiver Outlook - Patient|Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Topics included life review, issues of forgiveness and heritage and legacy.
171333|NCT01672294|B1|Baseline|Caregiver Outlook - Caregiver|Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Topics included life review, issues of forgiveness and heritage and legacy.
171334|NCT01672294|P4|Participant Flow|Relaxation Meditation - Patient|Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.
171335|NCT01672294|P3|Participant Flow|Relaxation Meditation - Caregiver|Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.
171336|NCT01672294|P2|Participant Flow|Caregiver Outlook - Patient|"Intervention: Three facilitator-led preparation and life completion sessions with caregiver.~Intervention: Three facilitator-led preparation and life completion sessions with caregiver.~Topics included life review, issues of forgiveness and heritage and legacy."
171337|NCT01672294|P1|Participant Flow|Caregiver Outlook - Caregiver|"Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Intervention: Three facilitator-led preparation and life completion sessions with caregiver.~Topics included life review, issues of forgiveness and heritage and legacy."
171338|NCT01672294|O2|Outcome|Relaxation Meditation - Caregiver|Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
171339|NCT01672294|O1|Outcome|Caregiver Outlook - Caregiver|Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
171340|NCT01672294|O2|Outcome|Relaxation Meditation - Caregiver|Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
171341|NCT01672294|O1|Outcome|Caregiver Outlook - Caregiver|Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
171342|NCT01672294|O2|Outcome|Relaxation Meditation - Caregiver|Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
171343|NCT01672294|O1|Outcome|Caregiver Outlook - Caregiver|Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
171344|NCT01672294|O2|Outcome|Relaxation Meditation - Caregiver|Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
171345|NCT01672294|O1|Outcome|Caregiver Outlook - Caregiver|Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
171346|NCT01672294|O2|Outcome|Relaxation Meditation - Patient|Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
171347|NCT01672294|O1|Outcome|Caregiver Outlook - Patient|Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
171348|NCT01672294|O2|Outcome|Relaxation Meditation - Caregiver|Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
171349|NCT01672294|O1|Outcome|Caregiver Outlook - Caregiver|Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
171350|NCT01672294|O2|Outcome|Relaxation Meditation - Caregiver|Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
171351|NCT01672294|O1|Outcome|Caregiver Outlook - Caregiver|Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
171352|NCT01672294|O2|Outcome|Relaxation Meditation - Caregiver|Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
171353|NCT01672294|O1|Outcome|Caregiver Outlook - Caregiver|Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
171354|NCT01672294|E4|Reported Event|Relaxation Meditation - Patient|Patients of the caregivers in the Attention Control arm.
171355|NCT01672294|E3|Reported Event|Relaxation Meditation - Caregiver|Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.
171356|NCT01672294|E2|Reported Event|Caregiver Outlook - Patient|Patients of the caregivers in the Outlook Intervention arm.
171357|NCT01672294|E1|Reported Event|Caregiver Outlook - Caregiver|Intervention: Three facilitator-led sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy.
171358|NCT01672242|B1|Baseline|Participants|Normal healthy adult volunteers
171359|NCT01672242|P2|Participant Flow|CPAP-HFNC|Continuous Positive Airway Pressure first period, followed by high flow nasal cannula second period.
171365|NCT01671839|B1|Baseline|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
171366|NCT01671839|P1|Participant Flow|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
171367|NCT01671839|O1|Outcome|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
171368|NCT01671839|O1|Outcome|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
171369|NCT01671839|O1|Outcome|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
171370|NCT01671839|O1|Outcome|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
171371|NCT01671839|O1|Outcome|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
171372|NCT01671839|O1|Outcome|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
171373|NCT01671839|E1|Reported Event|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
171374|NCT01671748|B3|Baseline|Total|Total of all reporting groups
171375|NCT01671748|B2|Baseline|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
171376|NCT01671748|B1|Baseline|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
171377|NCT01671748|P2|Participant Flow|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
171378|NCT01671748|P1|Participant Flow|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
171379|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
171380|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
171381|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
171382|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
171383|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
171384|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
171385|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
171386|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
171387|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
171388|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
171389|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
171390|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
171391|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
172154|NCT01668667|O1|Outcome|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
171392|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
171393|NCT01671748|E2|Reported Event|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
171394|NCT01671748|E1|Reported Event|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
171395|NCT01671605|B3|Baseline|Total|Total of all reporting groups
171396|NCT01671605|B2|Baseline|Controls|Controls with normal kidney function (Control)
171397|NCT01671605|B1|Baseline|CKD Not on Dialysis|Patients with CKD not on dialysis (CKD III-IV)
171398|NCT01671605|P2|Participant Flow|Controls|Controls with normal kidney function (Control)
171399|NCT01671605|P1|Participant Flow|CKD Not on Dialysis|Patients with CKD not on dialysis (CKD III-IV)
171400|NCT01671605|O2|Outcome|Controls|Controls with normal kidney function (Control)
171401|NCT01671605|O1|Outcome|CKD Not on Dialysis|Patients with CKD not on dialysis (CKD III-IV)
171402|NCT01671605|E2|Reported Event|Controls|Controls with normal kidney function (Control)
171403|NCT01671605|E1|Reported Event|CKD Not on Dialysis|Patients with CKD not on dialysis (CKD III-IV)
171404|NCT01671488|B1|Baseline|Treatment|"The first dose will be given 10-14 days prior to the initiation of chemoradiation.~Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.~The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.~Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.~5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days~Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)~IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction."
171405|NCT01671488|P1|Participant Flow|Treatment|"The first dose will be given 10-14 days prior to the initiation of chemoradiation.~Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.~The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.~Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.~5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days~Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)~IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction."
171406|NCT01671488|O1|Outcome|Treatment|"The first dose will be given 10-14 days prior to the initiation of chemoradiation.~Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.~The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.~Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.~5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days~Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)~IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction."
171407|NCT01671488|O1|Outcome|Treatment|"The first dose will be given 10-14 days prior to the initiation of chemoradiation.~Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.~The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.~Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.~5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days~Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)~IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction."
171408|NCT01671488|O1|Outcome|Treatment|"The first dose will be given 10-14 days prior to the initiation of chemoradiation.~Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.~The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.~Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.~5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days~Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)~IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction."
171409|NCT01671488|E1|Reported Event|Treatment|"The first dose will be given 10-14 days prior to the initiation of chemoradiation.~Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.~The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.~Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.~5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days~Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)~IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction."
171410|NCT01671319|B1|Baseline|Dose Dense TC + Pegfilgrastim|"Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle~docetaxel + cyclophosphamide + pegfilgrastim: docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle"
171411|NCT01671319|P1|Participant Flow|Dose Dense TC + Pegfilgrastim|"Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle~docetaxel + cyclophosphamide + pegfilgrastim: docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle"
171412|NCT01671319|O1|Outcome|Dose Dense TC + Pegfilgrastim|"Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle~docetaxel + cyclophosphamide + pegfilgrastim: docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle"
171413|NCT01671319|O1|Outcome|Dose Dense TC + Pegfilgrastim|"Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle~docetaxel + cyclophosphamide + pegfilgrastim: docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle"
171414|NCT01671319|O1|Outcome|Dose Dense TC + Pegfilgrastim|"Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle~docetaxel + cyclophosphamide + pegfilgrastim: docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle"
171415|NCT01671319|E1|Reported Event|Dose Dense TC + Pegfilgrastim|"Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle~docetaxel + cyclophosphamide + pegfilgrastim: docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle"
171416|NCT01671293|B3|Baseline|Total|Total of all reporting groups
171417|NCT01671293|B2|Baseline|Usual Care|Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.
171418|NCT01671293|B1|Baseline|Multicomponent Remote Care Model|Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.
171419|NCT01671293|P2|Participant Flow|Usual Care|Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.
171420|NCT01671293|P1|Participant Flow|Multicomponent Remote Care Model|Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.
171421|NCT01671293|O2|Outcome|Usual Care|Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.
171422|NCT01671293|O1|Outcome|Multicomponent Remote Care Model|Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.
171423|NCT01671293|E2|Reported Event|Usual Care|Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.
171424|NCT01671293|E1|Reported Event|Multicomponent Remote Care Model|Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.
171564|NCT01670656|O2|Outcome|NOMAC-E2 900/300 mcg|NOMAC-E2 900/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171425|NCT01671280|B1|Baseline|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
171426|NCT01671280|P1|Participant Flow|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
171427|NCT01671280|O1|Outcome|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
171428|NCT01671280|O1|Outcome|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
171429|NCT01671280|O1|Outcome|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
171430|NCT01671280|E1|Reported Event|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
171431|NCT01671176|B1|Baseline|Wide Diameter Bone Anchored Implant|"Intervention: Implantation of a wide diameter bone anchored auditory implant either 3 or 4 mm in length, into the skull on the side of the ear where intervention is intended in order to restore hearing. In the case of a conductive or mixed hearing loss, that side is chosen. In patients with unilateral, profound sensori-neural hearing loss the implant is implanted on that side but the sound is transmitted to the side with the normal hearing ear via bone conduction stimulation.~Wide diameter bone anchored implant: 4.5 mm wide diameter bone anchored implant"
171432|NCT01671176|P1|Participant Flow|Wide Diameter Bone Anchored Implant|"Intervention: Implantation of a wide diameter bone anchored auditory implant either 3 or 4 mm in length, into the skull on the side of the ear where intervention is intended in order to restore hearing. In the case of a conductive or mixed hearing loss, that side is chosen. In patients with unilateral, profound sensori-neural hearing loss the implant is implanted on that side but the sound is transmitted to the side with the normal hearing ear via bone conduction stimulation.~Wide diameter bone anchored implant: 4.5 mm wide diameter bone anchored implant"
171433|NCT01671176|O1|Outcome|Wide Diameter Bone Anchored Implant|"Intervention: Implantation of a wide diameter bone anchored auditory implant either 3 or 4 mm in length, into the skull on the side of the ear where intervention is intended in order to restore hearing. In the case of a conductive or mixed hearing loss, that side is chosen. In patients with unilateral, profound sensori-neural hearing loss the implant is implanted on that side but the sound is transmitted to the side with the normal hearing ear via bone conduction stimulation.~Wide diameter bone anchored implant: 4.5 mm wide diameter bone anchored implant"
171434|NCT01671176|O1|Outcome|Wide Diameter Bone Anchored Implant|"Intervention: Implantation of a wide diameter bone anchored auditory implant either 3 or 4 mm in length, into the skull on the side of the ear where intervention is intended in order to restore hearing. In the case of a conductive or mixed hearing loss, that side is chosen. In patients with unilateral, profound sensori-neural hearing loss the implant is implanted on that side but the sound is transmitted to the side with the normal hearing ear via bone conduction stimulation.~Wide diameter bone anchored implant: 4.5 mm wide diameter bone anchored implant"
171435|NCT01671176|E1|Reported Event|Wide Diameter Bone Anchored Implant|"Intervention: Implantation of a wide diameter bone anchored auditory implant either 3 or 4 mm in length, into the skull on the side of the ear where intervention is intended in order to restore hearing. In the case of a conductive or mixed hearing loss, that side is chosen. In patients with unilateral, profound sensori-neural hearing loss the implant is implanted on that side but the sound is transmitted to the side with the normal hearing ear via bone conduction stimulation.~Wide diameter bone anchored implant: 4.5 mm wide diameter bone anchored implant"
171436|NCT01671111|B1|Baseline|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
171437|NCT01671111|P1|Participant Flow|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 milligram per kilogram per day (mg/kg/day) (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
171438|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
171439|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
171440|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
171441|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
183880|NCT01627002|O1|Outcome|Part A PA401 0.1 mg|
171442|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
171443|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
171444|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
171445|NCT01671111|E1|Reported Event|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
171446|NCT01671059|B1|Baseline|Tocilizumab|Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
171447|NCT01671059|P1|Participant Flow|Tocilizumab|Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
171448|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
171449|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
171450|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
171451|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
171452|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
171453|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
171454|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
171455|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
171456|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
171457|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
171458|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
171459|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
171460|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
171461|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
171462|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
171463|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
171464|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
171465|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
171466|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
171467|NCT01671059|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
171468|NCT01671059|E1|Reported Event|Tocilizumab|Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
171469|NCT01670825|B3|Baseline|Total|Total of all reporting groups
171470|NCT01670825|B2|Baseline|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171471|NCT01670825|B1|Baseline|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171472|NCT01670825|P2|Participant Flow|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171473|NCT01670825|P1|Participant Flow|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171565|NCT01670656|O1|Outcome|NOMAC-E2 700/300 mcg|NOMAC-E2 700/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171474|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171475|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171476|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171477|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171478|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171479|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171480|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171481|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171482|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171483|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171484|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171485|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171486|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171487|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171488|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171489|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171490|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171491|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171492|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171493|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171494|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171495|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171566|NCT01670656|O5|Outcome|Placebo|Placebo was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
183881|NCT01627002|E9|Reported Event|Part B Placebo|
171496|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171497|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171498|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171499|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171500|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171501|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171502|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171503|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171504|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171505|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171506|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171507|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171508|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171509|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171510|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171511|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171512|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171513|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171514|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171515|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171516|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171517|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171567|NCT01670656|O4|Outcome|ENG-E2 125/300 mcg|ENG-E2 125/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171518|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171519|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171520|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171521|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171522|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171523|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171524|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171525|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171526|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171527|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171528|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171529|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171530|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171531|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171532|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve~Local anethestic injection"
171533|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve~Local anethestic injection"
171534|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171535|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171536|NCT01670825|E2|Reported Event|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
171537|NCT01670825|E1|Reported Event|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
171538|NCT01670721|B1|Baseline|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
171568|NCT01670656|O3|Outcome|ENG-E2 100/300 mcg|ENG-E2 100/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
172209|NCT01668628|O1|Outcome|Normohydration Group|Peritoneal dialysis patients with baseline -2L<OH value <+2L
171539|NCT01670721|P1|Participant Flow|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg intravenous (IV) infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until disease progression (DP), unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
171540|NCT01670721|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
171541|NCT01670721|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
171542|NCT01670721|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
171543|NCT01670721|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
171544|NCT01670721|E1|Reported Event|Aflibercept + FOLFIRI(Irinotecan, 5-Fluorouracil & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment (maximum exposure: Week 99).
171545|NCT01670656|B6|Baseline|Total|Total of all reporting groups
171546|NCT01670656|B5|Baseline|Placebo|Placebo was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171547|NCT01670656|B4|Baseline|ENG-E2 125/300 mcg|ENG-E2 125/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171548|NCT01670656|B3|Baseline|ENG-E2 100/300 mcg|ENG-E2 100/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171549|NCT01670656|B2|Baseline|NOMAC-E2 900/300 mcg|NOMAC-E2 900/300 mcg administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171550|NCT01670656|B1|Baseline|NOMAC-E2 700/300 mcg|NOMAC-E2 700/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171551|NCT01670656|P5|Participant Flow|Placebo|Placebo was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171552|NCT01670656|P4|Participant Flow|ENG-E2 125/300 mcg|ENG-E2 125/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171553|NCT01670656|P3|Participant Flow|ENG-E2 100/300 mcg|ENG-E2 100/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171554|NCT01670656|P2|Participant Flow|NOMAC-E2 900/300 mcg|NOMAC-E2 900/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171555|NCT01670656|P1|Participant Flow|NOMAC-E2 700/300 mcg|NOMAC-E2 700/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171556|NCT01670656|O5|Outcome|Placebo|Placebo was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171557|NCT01670656|O4|Outcome|ENG-E2 125/300 mcg|ENG-E2 125/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171558|NCT01670656|O3|Outcome|ENG-E2 100/300 mcg|ENG-E2 100/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171559|NCT01670656|O2|Outcome|NOMAC-E2 900/300 mcg|NOMAC-E2 900/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171560|NCT01670656|O1|Outcome|NOMAC-E2 700/300 mcg|NOMAC-E2 700/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171561|NCT01670656|O5|Outcome|Placebo|Placebo was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171562|NCT01670656|O4|Outcome|ENG-E2 125/300 mcg|ENG-E2 125/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171563|NCT01670656|O3|Outcome|ENG-E2 100/300 mcg|ENG-E2 100/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171569|NCT01670656|O2|Outcome|NOMAC-E2 900/300 mcg|NOMAC-E2 900/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171570|NCT01670656|O1|Outcome|NOMAC-E2 700/300 mcg|NOMAC-E2 700/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171571|NCT01670656|O5|Outcome|Placebo|Placebo was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171572|NCT01670656|O4|Outcome|ENG-E2 125/300 mcg|ENG-E2 125/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171573|NCT01670656|O3|Outcome|ENG-E2 100/300 mcg|ENG-E2 100/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171574|NCT01670656|O2|Outcome|NOMAC-E2 900/300 mcg|NOMAC-E2 900/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171575|NCT01670656|O1|Outcome|NOMAC-E2 700/300 mcg|NOMAC-E2 700/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171576|NCT01670656|E5|Reported Event|Placebo|Placebo was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171577|NCT01670656|E4|Reported Event|ENG-E2 (125/300 mcg)|ENG-E2 125/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171578|NCT01670656|E3|Reported Event|ENG-E2 (100/300 mcg)|ENG-E2 100/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171579|NCT01670656|E2|Reported Event|NOMAC-E2 (900/300 mcg)|NOMAC-E2 900/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
171580|NCT01670656|E1|Reported Event|NOMAC-E2 (700/300 mcg)|NOMAC-E2 700/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days
171581|NCT01670526|B3|Baseline|Total|Total of all reporting groups
171582|NCT01670526|B2|Baseline|Placebo|"Placebo~Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
171583|NCT01670526|B1|Baseline|Rivastigmine|"Rivastigmine transdermal patch~Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
171584|NCT01670526|P2|Participant Flow|Placebo|"Placebo~Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
171585|NCT01670526|P1|Participant Flow|Rivastigmine|"Rivastigmine transdermal patch~Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
171586|NCT01670526|O2|Outcome|Placebo|"Placebo~Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
171587|NCT01670526|O1|Outcome|Rivastigmine|"Rivastigmine transdermal patch~Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
171588|NCT01670526|O2|Outcome|Placebo|"Placebo~Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
171589|NCT01670526|O1|Outcome|Rivastigmine|"Rivastigmine transdermal patch~Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
171590|NCT01670526|O2|Outcome|Placebo|"Placebo~Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
171591|NCT01670526|O1|Outcome|Rivastigmine|"Rivastigmine transdermal patch~Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
171592|NCT01670526|O2|Outcome|Placebo|"Placebo~Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
171593|NCT01670526|O1|Outcome|Rivastigmine|"Rivastigmine transdermal patch~Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
171594|NCT01670526|E2|Reported Event|Placebo|"Placebo~Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
171595|NCT01670526|E1|Reported Event|Rivastigmine|"Rivastigmine transdermal patch~Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
171596|NCT01670487|B3|Baseline|Total|Total of all reporting groups
171597|NCT01670487|B2|Baseline|Nature's Tears|Applied Nature's Tears in a topical stream of 4 to 10 seconds duration to skin
171598|NCT01670487|B1|Baseline|Vapocoolant (Pain Ease Medium Stream)|Applied Vapoccolant in a topical stream of 4 to 10 seconds duration to skin
171599|NCT01670487|P2|Participant Flow|Nature's Tears|"Apply sterile water (see manufacturer above) steadily 4-10 seconds onto the cannulation site.~Sterile water: Topical intervention of sterile water stream 4 to 10 seconds to skin."
171600|NCT01670487|P1|Participant Flow|Vapocoolant (Pain Ease Medium Stream)|"Application of the stream steadily 4 to 10 seconds onto the cannulation site.~Vapocoolant: Topical stream of 4 to 10 seconds duration to skin"
171601|NCT01670487|O2|Outcome|Placebo (Nature's Tears)|Application of the stream steadily for 4 to 10 seconds
171602|NCT01670487|O1|Outcome|Vapocoolant (Pain Ease Medium Stream)|"Application of the stream steadily 4 to 10 seconds onto the cannulation site.~Vapocoolant: Topical stream of 4 to 10 seconds duration to skin"
171603|NCT01670487|E2|Reported Event|Nature's Tears|"Apply sterile water (see manufacturer above) steadily 4-10 seconds onto the cannulation site.~Sterile water: Topical intervention of sterile water stream 4 to 10 seconds to skin."
171604|NCT01670487|E1|Reported Event|Vapocoolant (Pain Ease Medium Stream)|"Application of the stream steadily 4 to 10 seconds onto the cannulation site.~Vapocoolant: Topical stream of 4 to 10 seconds duration to skin"
171605|NCT01670292|B1|Baseline|Experimental: HVLA-SM|"Experimental High Velocity Low Amplitude Spinal Manipulation~HVLA-SM: High Velocity Low Amplitude Spinal Manipulation"
171606|NCT01670292|P1|Participant Flow|Experimental: HVLA-SM|"Experimental High Velocity Low Amplitude Spinal Manipulation~HVLA-SM: High Velocity Low Amplitude Spinal Manipulation~Participants receive treatments of HVLA-SM to the lumbar spine in the side-lying position. Treatment frequency is twice per week for 6 weeks."
171607|NCT01670292|O3|Outcome|HVLA-SM After 6 Weeks|There is only one group/arm, this is the data for the same group of participants after six weeks.
171608|NCT01670292|O2|Outcome|HVLA-SM After 2 Weeks|There is only one group/arm, this is the data for the same group of participants after two weeks.
171609|NCT01670292|O1|Outcome|HVLA-SM at Baseline|"Results at Baseline~Experimental High Velocity Low Amplitude Spinal Manipulation~HVLA-SM: High Velocity Low Amplitude Spinal Manipulation"
171610|NCT01670292|O3|Outcome|HVLA-SM After 6 Weeks|There is only one group/arm, this is the data for the same group of participants after six weeks.
171611|NCT01670292|O2|Outcome|HVLA-SM After 2 Weeks|There is only one group/arm, this is the data for the same group of participants after two weeks.
171612|NCT01670292|O1|Outcome|HVLA-SM at Baseline|"Result at baseline. Experimental High Velocity Low Amplitude Spinal Manipulation~HVLA-SM: High Velocity Low Amplitude Spinal Manipulation"
171613|NCT01670292|O3|Outcome|HVLA-SM After 6 Weeks|There is only one group/arm, this is the data for the same group of participants after six weeks.
171614|NCT01670292|O2|Outcome|HVLA-SM After 2 Weeks|There is only one group/arm, this is the data for the same group of participants after two weeks.
171615|NCT01670292|O1|Outcome|HVLA-SM at Baseline|"Result at baseline. Experimental High Velocity Low Amplitude Spinal Manipulation~HVLA-SM: High Velocity Low Amplitude Spinal Manipulation"
171616|NCT01670292|O4|Outcome|Combined|All participants are in this group, this simply defines the mean Combined force/moment (C).
171617|NCT01670292|O3|Outcome|Head-to-Toe (Z)|All participants are in this group, this simply defines the mean force/moment in the Z direction.
171618|NCT01670292|O2|Outcome|Side-to-Side (Y)|All participants are in this group, this simply defines the mean force/moment in the Y direction.
171619|NCT01670292|O1|Outcome|Anterior-Posterior (X)|All participants are in this group, this simply defines the mean force/moment in the X direction.
171620|NCT01670292|O4|Outcome|Combined|All participants are in this group, this simply defines the mean Combined force/moment (C).
171621|NCT01670292|O3|Outcome|Head-to-Toe (Z)|All participants are in this group, this simply defines the mean force/moment in the Z direction.
171622|NCT01670292|O2|Outcome|Side-to-Side (Y)|All participants are in this group, this simply defines the mean force/moment in the Y direction.
171623|NCT01670292|O1|Outcome|Anterior-Posterior (X)|All participants are in this group, this simply defines the mean force/moment in the X direction.
171624|NCT01670292|O4|Outcome|Combined|All participants are in this group, this simply defines the mean Combined force/moment (C).
171625|NCT01670292|O3|Outcome|Head-to-Toe (Z)|All participants are in this group, this simply defines the mean force/moment in the Z direction.
171626|NCT01670292|O2|Outcome|Side-to-Side (Y)|All participants are in this group, this simply defines the mean force/moment in the Y direction.
171627|NCT01670292|O1|Outcome|Anterior-Posterior (X)|All participants are in this group, this simply defines the mean force/moment in the X direction.
171628|NCT01670292|O4|Outcome|Combined|All participants are in this group, this simply defines the mean Combined force/moment (C).
171629|NCT01670292|O3|Outcome|Head-to-Toe (Z)|All participants are in this group, this simply defines the mean force/moment in the Z direction.
171630|NCT01670292|O2|Outcome|Side-to-Side (Y)|All participants are in this group, this simply defines the mean force/moment in the Y direction.
171631|NCT01670292|O1|Outcome|Anterior-Posterior (X)|All participants are in this group, this simply defines the mean force/moment in the X direction.
171632|NCT01670292|O3|Outcome|HVLA-SM After 6 Weeks|There is only one group/arm, this is the data for the same group of participants after six weeks.
171633|NCT01670292|O2|Outcome|HVLA-SM After 2 Weeks|There is only one group/arm, this is the data for the same group of participants after two weeks.
171634|NCT01670292|O1|Outcome|HVLA-SM at Baseline|"Results at Baseline~Experimental High Velocity Low Amplitude Spinal Manipulation~HVLA-SM: High Velocity Low Amplitude Spinal Manipulation"
171635|NCT01670292|O3|Outcome|HVLA-SM After 6 Weeks|There is only one group/arm, this is the data for the same group of participants after six weeks.
171636|NCT01670292|O2|Outcome|HVLA-SM After 2 Weeks|There is only one group/arm, this is the data for the same group of participants after two weeks.
171637|NCT01670292|O1|Outcome|HVLA-SM at Baseline|"Results at Baseline~Experimental High Velocity Low Amplitude Spinal Manipulation~HVLA-SM: High Velocity Low Amplitude Spinal Manipulation"
171638|NCT01670292|O3|Outcome|HVLA-SM After 6 Weeks|There is only one group/arm, this is the data for the same group of participants after six weeks.
171639|NCT01670292|O2|Outcome|HVLA-SM After 2 Weeks|There is only one group/arm, this is the data for the same group of participants after two weeks.
171640|NCT01670292|O1|Outcome|HVLA-SM at Baseline|"Results at Baseline~Experimental High Velocity Low Amplitude Spinal Manipulation~HVLA-SM: High Velocity Low Amplitude Spinal Manipulation"
171641|NCT01670292|O1|Outcome|Experimental: HVLA-SM|"Experimental High Velocity Low Amplitude Spinal Manipulation~HVLA-SM: High Velocity Low Amplitude Spinal Manipulation"
171642|NCT01670292|E1|Reported Event|Experimental: HVLA-SM*|"Experimental High Velocity Low Amplitude Spinal Manipulation~HVLA-SM: High Velocity Low Amplitude Spinal Manipulation"
171643|NCT01670279|B4|Baseline|Total|Total of all reporting groups
171644|NCT01670279|B3|Baseline|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
171645|NCT01670279|B2|Baseline|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
171646|NCT01670279|B1|Baseline|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
171647|NCT01670279|P4|Participant Flow|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
171648|NCT01670279|P3|Participant Flow|Brexpiprazole-Cohort 3|In the titration phase, participants were to receive 0.5 mg brexpiprazole or placebo QD for 7 days, followed by 1 mg brexpiprazole or placebo QD for 7 days, and then 2 mg brexpiprazole or placebo QD for 7 days. In the fixed dose phase, participants were to receive 3 mg brexpiprazole or placebo QD for 14 days. However, Cohort 3 was not conducted due to safety and tolerability results from Cohorts 1 and 2.
173058|NCT01665157|B1|Baseline|Low-residue Diet Package (Enimaclin®) and 2L PEG|Low-residue diet package with normal amount of 2L PEG-ELS
171649|NCT01670279|P2|Participant Flow|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
171650|NCT01670279|P1|Participant Flow|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
171651|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
171652|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
171653|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
171654|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
171655|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
171656|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
171657|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
171658|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
171659|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
171660|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
171661|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
171662|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
171663|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
171664|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
171665|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
171666|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
171667|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
171668|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
171669|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
171670|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
171671|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
171672|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
171673|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
171674|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
171675|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
171676|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
171677|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
171678|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
171679|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
171680|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
171681|NCT01670279|E3|Reported Event|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
171682|NCT01670279|E2|Reported Event|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
171683|NCT01670279|E1|Reported Event|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
171684|NCT01670201|B1|Baseline|Mepilex Transfer Ag|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: Silver dressing"
171685|NCT01670201|P1|Participant Flow|Mepilex Transfer Ag|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: Silver dressing"
171686|NCT01670201|O1|Outcome|Mepilex Transfer Ag|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: Silver dressing"
171687|NCT01670201|O1|Outcome|Mepilex Transfer Ag|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: Silver dressing"
171688|NCT01670201|E1|Reported Event|Mepilex Transfer Ag|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: Silver dressing"
171689|NCT01670188|B3|Baseline|Total|Total of all reporting groups
171690|NCT01670188|B2|Baseline|Non-SCD Group|Patients enrolled in this group received standard care.
171691|NCT01670188|B1|Baseline|Pneumatic SCD|Use of pneumatic sequential compression device (SCD) (VenaFlow System - DJO Global) on upper extremity with peripherally inserted central catheter (PICC) line inserted.
171692|NCT01670188|P2|Participant Flow|Non-SCD Group|Patients enrolled in this group received standard care.
171693|NCT01670188|P1|Participant Flow|Pneumatic SCD|Use of pneumatic sequential compression device (SCD) (VenaFlow System - DJO Global) on upper extremity with peripherally inserted central catheter (PICC) line inserted.
171694|NCT01670188|O2|Outcome|Non-SCD Group|Patients enrolled in this group received standard care.
171695|NCT01670188|O1|Outcome|Pneumatic SCD|Use of pneumatic sequential compression device (SCD) (VenaFlow System - DJO Global) on upper extremity with peripherally inserted central catheter (PICC) line inserted.
171696|NCT01670188|E2|Reported Event|Non-SCD Group|Patients enrolled in this group received standard care.
171697|NCT01670188|E1|Reported Event|Pneumatic SCD|Use of pneumatic sequential compression device (SCD) (VenaFlow System - DJO Global) on upper extremity with peripherally inserted central catheter (PICC) line inserted.
171698|NCT01670045|B1|Baseline|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
171699|NCT01670045|P1|Participant Flow|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joint Count (DAS28) who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
171986|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
171700|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
171701|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
171702|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
171703|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
171704|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
171705|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
171706|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
171707|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
171708|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
171709|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
171710|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
171711|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
171712|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
171713|NCT01670045|E1|Reported Event|Rheumatoid Arthritis Participants|Participants with moderate to severe RA and the DAS28 joint scores who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
171714|NCT01670019|B3|Baseline|Total|Total of all reporting groups
171715|NCT01670019|B2|Baseline|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
171716|NCT01670019|B1|Baseline|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
183882|NCT01627002|E8|Reported Event|Part B PA401 3.0 mg|
171717|NCT01670019|P2|Participant Flow|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
171718|NCT01670019|P1|Participant Flow|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
171719|NCT01670019|O2|Outcome|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
171720|NCT01670019|O1|Outcome|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
171721|NCT01670019|O2|Outcome|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
171722|NCT01670019|O1|Outcome|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
171723|NCT01670019|O2|Outcome|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
171724|NCT01670019|O1|Outcome|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
171725|NCT01670019|O2|Outcome|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
171726|NCT01670019|O1|Outcome|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
171727|NCT01670019|O2|Outcome|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
171728|NCT01670019|O1|Outcome|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
171729|NCT01670019|E2|Reported Event|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
171730|NCT01670019|E1|Reported Event|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
171731|NCT01669902|B1|Baseline|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
171732|NCT01669902|P1|Participant Flow|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
171733|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
171734|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
171735|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
171736|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
171737|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
171738|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
171739|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
171740|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
171741|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
172068|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
171742|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
171743|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
171744|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
171745|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
171746|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
171747|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
171748|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
171749|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
171750|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
171751|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
171752|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
171753|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
171754|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
171755|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
171756|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
171757|NCT01669902|E1|Reported Event|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
171758|NCT01669863|B1|Baseline|Use of ECMO in Non-intubated Patients|ECMO group
171759|NCT01669863|P1|Participant Flow|Use of ECMO in Non-intubated Patients|"ECMO used in non-intubated patients with ARDS~ECMO~ECMO in non-intubated patients"
171760|NCT01669863|O1|Outcome|Use of ECMO in Non-intubated Patients|ECMO in non-intubated patients
171761|NCT01669863|O1|Outcome|Use of ECMO in Non-intubated Patients|ECMO in non-intubated patients
171762|NCT01669863|O1|Outcome|Use of ECMO in Non-intubated Patients|"ECMO will be used in non-intubated patients with ARDS~ECMO~ECMO in non-intubated patients"
171763|NCT01669863|E1|Reported Event|Use of ECMO in Non-intubated Patients|Patients on ECMO
171764|NCT01669811|B3|Baseline|Total|Total of all reporting groups
171765|NCT01669811|B2|Baseline|D961H 20 mg QD + Placebo|D961H 20 mg once daily along with placebo
171766|NCT01669811|B1|Baseline|D961H 20 mg BID|D961H 20 mg twice Daily
171767|NCT01669811|P2|Participant Flow|D961H 20 mg QD + Placebo|Hard capsule unidentifiable to D961H capsule 20 mg
171768|NCT01669811|P1|Participant Flow|D961H 20 mg BID|Hard capsule containing 22.3 mg of D961H as enteric coated pellets
171769|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
171770|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
171771|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
171772|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
171773|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
171774|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
171775|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
171776|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
171777|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
171778|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
171779|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
171780|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
171781|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
171782|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
171783|NCT01669811|E2|Reported Event|D961H 20 mg QD + Placebo|D961H 20 mg once daily along with placebo
171784|NCT01669811|E1|Reported Event|D961H 20 mg BID|D961H 20 mg twice Daily
171785|NCT01669785|B4|Baseline|Total|Total of all reporting groups
171786|NCT01669785|B3|Baseline|Group C|NUPRO Classic Prophy Paste.Administered on day one only.Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride.Leave in contact for 60 seconds, rinse with water and expectorate.
171787|NCT01669785|B2|Baseline|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride.Administered on day one only.Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
171842|NCT01669642|P6|Participant Flow|Abscess Drainage Group 12-17 Years|children between 12-17 years who needs ketamine sedation for abscess drainage in the emergency department are enrolled in this group.
171788|NCT01669785|B1|Baseline|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin. Administered on day one only.Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
171789|NCT01669785|P3|Participant Flow|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
171790|NCT01669785|P2|Participant Flow|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
171791|NCT01669785|P1|Participant Flow|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
171792|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
171793|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
171794|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
171795|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
171796|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
171797|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
171798|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
171799|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
171800|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
171801|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
171802|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
171803|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
171804|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
171805|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
171806|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
171807|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
171808|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
171809|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
171810|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
171811|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
171812|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
171813|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
171814|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
171815|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
171816|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
171817|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
171818|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
171819|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
171820|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
171821|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
171822|NCT01669785|E3|Reported Event|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
171823|NCT01669785|E2|Reported Event|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
171824|NCT01669785|E1|Reported Event|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
171825|NCT01669720|B3|Baseline|Total|Total of all reporting groups
171826|NCT01669720|B2|Baseline|Observation|Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
171827|NCT01669720|B1|Baseline|Aflibercept|"Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years~Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years"
171828|NCT01669720|P2|Participant Flow|Observation|Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
171829|NCT01669720|P1|Participant Flow|Aflibercept|"Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years~Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years"
171830|NCT01669720|O2|Outcome|Observation|Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
171831|NCT01669720|O1|Outcome|Aflibercept|"Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years~Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years"
171832|NCT01669720|O2|Outcome|Observation|Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
171833|NCT01669720|O1|Outcome|Aflibercept|"Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years~Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years"
171834|NCT01669720|E2|Reported Event|Observation|Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
171835|NCT01669720|E1|Reported Event|Aflibercept|"Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years~Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years"
171836|NCT01669642|B6|Baseline|Total|Total of all reporting groups
171837|NCT01669642|B5|Baseline|Abscess Drainage Group 6-11 Years|participants who need ketamine sedation for abscess drainage will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
171838|NCT01669642|B4|Baseline|Abscess Drainage Group 2-5 Years|participants who need ketamine sedation for abscess drainage will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
171839|NCT01669642|B3|Baseline|Fracture Reduction Group 12-17 Years|participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
171840|NCT01669642|B2|Baseline|Fracture Reduction Group 6-11 Years|participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
171841|NCT01669642|B1|Baseline|Fracture Reduction Group 2-5 Years|participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
171843|NCT01669642|P5|Participant Flow|Abscess Drainage Group 6-11 Years|children between 6-11 years who needs ketamine sedation for abscess drainage in the emergency department are enrolled in this group.
171844|NCT01669642|P4|Participant Flow|Abscess Drainage Group 2-5 Years|children between 2-5 years who needs ketamine sedation for abscess drainage in the emergency department are enrolled in this group.
171845|NCT01669642|P3|Participant Flow|Fracture Reduction Group 12-17 Years|children between 12-17 years who needs ketamine sedation for fracture reduction in the emergency department are enrolled in this group.
171846|NCT01669642|P2|Participant Flow|Fracture Reduction Group 6-11 Years|children between 6-11 years who needs ketamine sedation for fracture reduction in the emergency department are enrolled in this group.
171847|NCT01669642|P1|Participant Flow|Fracture Reduction Group 2-5 Years|children between 2-5 years who needs ketamine sedation for fracture reduction in the emergency department are enrolled in this group.
171848|NCT01669642|O5|Outcome|Abscess Drainage Group 6-11 Years|children between 6-11 years of age who need abscess drainage under ketamine sedation are enrolled in this group.
171849|NCT01669642|O4|Outcome|Abscess Drainage Group 2-5 Years|children between 2-5 years of age who need abscess drainage under ketamine sedation are enrolled in this group.
171850|NCT01669642|O3|Outcome|Fracture Reduction Group 12-17 Years|children between 12-17 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
171851|NCT01669642|O2|Outcome|Fracture Reduction Group 6-11 Years|children between 6-11 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
171852|NCT01669642|O1|Outcome|Fracture Reduction Group 2-5 Years|children between 2-5 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
171853|NCT01669642|O5|Outcome|Abscess Drainage Group 6-11 Years|children between 6-11 years of age who need abscess drainage under ketamine sedation are enrolled in this group.
171854|NCT01669642|O4|Outcome|Abscess Drainage Group 2-5 Years|children between 2-5 years of age who need abscess drainage under ketamine sedation are enrolled in this group.
171855|NCT01669642|O3|Outcome|Fracture Reduction Group 12-17 Years|children between 12-17 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
171856|NCT01669642|O2|Outcome|Fracture Reduction Group 6-11 Years|children between 6-11 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
171857|NCT01669642|O1|Outcome|Fracture Reduction Group 2-5 Years|children between 2-5 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
171858|NCT01669642|O5|Outcome|Abscess Drainage Group 6-11 Years|children between 6-11 years of age who need abscess drainage under ketamine sedation are enrolled in this group.
171859|NCT01669642|O4|Outcome|Abscess Drainage Group 2-5 Years|children between 2-5 years of age who need abscess drainage under ketamine sedation are enrolled in this group.
171860|NCT01669642|O3|Outcome|Fracture Reduction Group 12-17 Years|children between 12-17 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
171861|NCT01669642|O2|Outcome|Fracture Reduction Group 6-11 Years|children between 6-11 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
171862|NCT01669642|O1|Outcome|Fracture Reduction Group 2-5 Years|children between 2-5 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
171863|NCT01669642|O5|Outcome|Abscess Drainage Group 6-11 Years|participants who need ketamine sedation for abscess drainage will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
171864|NCT01669642|O4|Outcome|Abscess Drainage Group 2-5 Years|participants who need ketamine sedation for abscess drainage will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
171865|NCT01669642|O3|Outcome|Fracture Reduction Group 12-17 Years|participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
171866|NCT01669642|O2|Outcome|Fracture Reduction Group 6-11 Years|participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
171867|NCT01669642|O1|Outcome|Fracture Reduction Group 2-5 Years|participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
171868|NCT01669642|O5|Outcome|Abscess Drainage Group 6-11 Years|children between 6-11 years of age who need abscess drainage under ketamine sedation are enrolled in this group.
171869|NCT01669642|O4|Outcome|Abscess Drainage Group 2-5 Years|children between 2-5 years of age who need abscess drainage under ketamine sedation are enrolled in this group.
171870|NCT01669642|O3|Outcome|Fracture Reduction Group 12-17 Years|children between 12-17 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
171871|NCT01669642|O2|Outcome|Fracture Reduction Group 6-11 Years|children between 6-11 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
171872|NCT01669642|O1|Outcome|Fracture Reduction Group 2-5 Years|children between 2-5 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
171873|NCT01669642|E5|Reported Event|Abscess Drainage Group 6-11 Years|participants who need ketamine sedation for abscess drainage will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
171874|NCT01669642|E4|Reported Event|Abscess Drainage Group 2-5 Years|participants who need ketamine sedation for abscess drainage will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
171985|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
171875|NCT01669642|E3|Reported Event|Fracture Reduction Group 12-17 Years|participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
171876|NCT01669642|E2|Reported Event|Fracture Reduction Group 6-11 Years|participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
171877|NCT01669642|E1|Reported Event|Fracture Reduction Group 2-5 Years|participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
171878|NCT01669629|B1|Baseline|All Subjects|All subjects who were enrolled in the study.
171879|NCT01669629|P2|Participant Flow|Etafilcon A \ Delefilcon A|"6-10 days of etafilcon A soft contact lens wear first then 6-10 days of delefilcon A soft contact lens wear~delefilcon A: Daily wear soft contact lens for bilateral distance vision correction use.~etafilcon A: Daily wear soft contact lens for bilateral distance vision correction use."
171880|NCT01669629|P1|Participant Flow|Delefilcon A \ Etafilcon A|"6-10 days of delefilcon A soft contact lens wear first then 6-10 days of etafilcon A soft contact lens wear~delefilcon A: Daily wear soft contact lens for bilateral distance vision correction use.~etafilcon A: Daily wear soft contact lens for bilateral distance vision correction use."
171881|NCT01669629|O2|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
171882|NCT01669629|O1|Outcome|Delefilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
171883|NCT01669629|O2|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
171884|NCT01669629|O1|Outcome|Delefilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
171885|NCT01669629|O2|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
171886|NCT01669629|O1|Outcome|Delefilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
171887|NCT01669629|O2|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
171888|NCT01669629|O1|Outcome|Delefilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
171889|NCT01669629|O2|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
171890|NCT01669629|O1|Outcome|Delefilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
171891|NCT01669629|E2|Reported Event|Etafilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
171892|NCT01669629|E1|Reported Event|Delefilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
171893|NCT01669603|B3|Baseline|Total|Total of all reporting groups
171894|NCT01669603|B2|Baseline|Placebo|"Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.~Placebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product."
171895|NCT01669603|B1|Baseline|Bifidobacterium Animalis Lactis Bl-04|"Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.~Bifidobacterium lactis Bl-04: The study product will be a 2*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier."
171896|NCT01669603|P2|Participant Flow|Placebo|"Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.~Placebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product."
171897|NCT01669603|P1|Participant Flow|Bifidobacterium Animalis Lactis Bl-04|"Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.~Bifidobacterium lactis Bl-04: The study product will be a 2*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier."
171898|NCT01669603|O2|Outcome|Placebo|"Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.~Placebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product."
171899|NCT01669603|O1|Outcome|Bifidobacterium Animalis Lactis Bl-04|"Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.~Bifidobacterium lactis Bl-04: The study product will be a 2*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier."
171900|NCT01669603|E2|Reported Event|Placebo|"Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.~Placebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product."
171901|NCT01669603|E1|Reported Event|Bifidobacterium Animalis Lactis Bl-04|"Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.~Bifidobacterium lactis Bl-04: The study product will be a 2*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier."
171902|NCT01669577|B1|Baseline|Severe Trauma Patients|Hypotensive Patients (SBP<90mmHg), severe TBI, high energy traumas All patients must have calculated ISS >15 to be included and a written informed consent should be available
171903|NCT01669577|P1|Participant Flow|Severe Trauma Patients|"intervention : analysis of blood samples~analysis of blood samples (0,2 ml): analysis of blood samples (0,2 ml)~analysis of blood samples: analysis of blood samples regarding electrolytes, blood gases, glucose, PT/INR collection of vital signs, blood chemistry; severity scores and intensive care unit(ICU) LOS(length of stay) were recorded"
171904|NCT01669577|O1|Outcome|Severe Trauma Patients|"intervention : analysis of blood samples; vital signs and clinical outcomes recorded~analysis of blood samples (0,2 ml): analysis of blood samples (0,2 ml)~analysis of blood samples: analysis of blood samples regarding electrolytes, blood gases, glucose, PT/INR"
171905|NCT01669577|E1|Reported Event|Severe Trauma Patients|"intervention : analysis of blood samples~analysis of blood samples (0,2 ml): analysis of blood samples (0,2 ml)~analysis of blood samples: analysis of blood samples regarding electrolytes, blood gases, glucose, PT/INR"
171906|NCT01669434|B3|Baseline|Total|Total of all reporting groups
177412|NCT01649362|B1|Baseline|Control Group|no prefeeding oral stimulation
171907|NCT01669434|B2|Baseline|ACEI Continuation|"Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose.~ACEI continuation: These chronic medications will be given without interruption preoperatively."
171908|NCT01669434|B1|Baseline|ACEI Omission|"Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose.~ACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or evening before surgery, whenever the last preoperative dose would normally occur."
171909|NCT01669434|P2|Participant Flow|ACEI Continuation|"Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose.~ACEI continuation: These chronic medications will be given without interruption preoperatively."
171910|NCT01669434|P1|Participant Flow|ACEI Omission|"Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose.~ACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or day before surgery, whenever the last preoperative dose would normally occur."
171911|NCT01669434|O2|Outcome|ACEI Continuation|"Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose.~ACEI continuation: These chronic medications will be given without interruption preoperatively."
171912|NCT01669434|O1|Outcome|ACEI Omission|"Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose.~ACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or evening before surgery, whenever the last preoperative dose would normally occur."
171913|NCT01669434|O2|Outcome|ACEI Continuation|"Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose.~ACEI continuation: These chronic medications will be given without interruption preoperatively."
171914|NCT01669434|O1|Outcome|ACEI Omission|"Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose.~ACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or evening before surgery, whenever the last preoperative dose would normally occur."
171915|NCT01669434|O2|Outcome|ACEI Continuation|"Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose.~ACEI continuation: These chronic medications will be given without interruption preoperatively."
171916|NCT01669434|O1|Outcome|ACEI Omission|"Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose.~ACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or evening before surgery, whenever the last preoperative dose would normally occur."
171917|NCT01669434|O2|Outcome|ACEI Continuation|"Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose.~ACEI continuation: These chronic medications will be given without interruption preoperatively."
171918|NCT01669434|O1|Outcome|ACEI Omission|"Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose.~ACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or evening before surgery, whenever the last preoperative dose would normally occur."
171919|NCT01669434|O2|Outcome|ACEI Continuation|"Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose.~ACEI continuation: These chronic medications will be given without interruption preoperatively."
171920|NCT01669434|O1|Outcome|ACEI Omission|"Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose.~ACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or evening before surgery, whenever the last preoperative dose would normally occur."
171921|NCT01669434|O2|Outcome|ACEI Continuation|"Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose.~ACEI continuation: These chronic medications will be given without interruption preoperatively."
171922|NCT01669434|O1|Outcome|ACEI Omission|"Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose.~ACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or evening before surgery, whenever the last preoperative dose would normally occur."
171923|NCT01669434|E2|Reported Event|ACEI Continuation|"Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose.~ACEI continuation: These chronic medications will be given without interruption preoperatively."
171924|NCT01669434|E1|Reported Event|ACEI Omission|"Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose.~ACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or evening before surgery, whenever the last preoperative dose would normally occur."
171925|NCT01669174|B3|Baseline|Total|Total of all reporting groups
171926|NCT01669174|B2|Baseline|Placebo|Placebo to BYM338 30mg/kg
171927|NCT01669174|B1|Baseline|BYM338|30 mg/kg
171928|NCT01669174|P2|Participant Flow|Placebo|Placebo to BYM338 30mg/kg
171929|NCT01669174|P1|Participant Flow|BYM338|30 mg/kg
171930|NCT01669174|O1|Outcome|BYM338|30 mg/kg
171931|NCT01669174|O1|Outcome|BYM338|30 mg/kg
171932|NCT01669174|O1|Outcome|BYM338|30 mg/kg
171933|NCT01669174|O2|Outcome|Placebo|Placebo to BYM338 30mg/kg
171934|NCT01669174|O1|Outcome|BYM338|30 mg/kg
171935|NCT01669174|O2|Outcome|Placebo|Placebo to BYM338 30mg/kg
171936|NCT01669174|O1|Outcome|BYM338|30 mg/kg
171937|NCT01669174|E2|Reported Event|Placebo|Placebo to BYM338 30mg/kg
171938|NCT01669174|E1|Reported Event|BYM338 30mg/kg|BYM338 30mg/kg
171939|NCT01669148|B1|Baseline|All Study Participants|All study participants in both arms. 496 enrolled and 426 completed study, but no information available to distinguish study arms.
171940|NCT01669148|P1|Participant Flow|All Study Participants|All participants enrolled in study
171941|NCT01669148|O2|Outcome|Tomosynthesis Alone First Then Conventional+Tomo 1 mo. Later|"Tomosynthesis: The mean glandular radiation dose for each image will be approximately 145 millirads (mrad) for a standard size breast (4.2 cm compressed breast thickness).~Conventional: conventional (2D) imaging (standard mammography)"
171942|NCT01669148|O1|Outcome|Conventional + Tomosynthesis First Then Tomo Alone 1 mo. Later|"Tomosynthesis: The mean glandular radiation dose for each image will be approximately 145 millirads (mrad) for a standard size breast (4.2 cm compressed breast thickness).~Conventional: conventional (2D) imaging (standard mammography)"
171943|NCT01669148|E1|Reported Event|All Study Participants|All participants enrolled in the study
171944|NCT01669122|B1|Baseline|Safety Population|Baseline measurements were performed for safety population which included all participants in the study who were dispensed at least one of the study treatment. Out of 40 randomized participants, one participant did not receive any treatment and was lost to follow-up.
171945|NCT01669122|P1|Participant Flow|Total Participants|
171946|NCT01669122|O4|Outcome|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
171947|NCT01669122|O3|Outcome|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
171948|NCT01669122|O2|Outcome|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
171949|NCT01669122|O1|Outcome|Test Lozenge (A)|4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
171950|NCT01669122|O4|Outcome|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
171951|NCT01669122|O3|Outcome|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
171952|NCT01669122|O2|Outcome|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
171953|NCT01669122|O1|Outcome|Test Lozenge (A)|4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
171954|NCT01669122|O4|Outcome|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
171955|NCT01669122|O3|Outcome|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
171956|NCT01669122|O2|Outcome|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
171957|NCT01669122|O1|Outcome|Test Lozenge (A)|4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
171958|NCT01669122|O4|Outcome|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
171959|NCT01669122|O3|Outcome|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
171960|NCT01669122|O2|Outcome|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
171961|NCT01669122|O1|Outcome|Test Lozenge (A)|4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
171962|NCT01669122|O4|Outcome|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
171963|NCT01669122|O3|Outcome|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
171964|NCT01669122|O2|Outcome|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
171965|NCT01669122|O1|Outcome|Test Lozenge (A)|4 mg nicotine lozenge with excipient A was administered orally as a single dose treatment.
171966|NCT01669122|O4|Outcome|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
171967|NCT01669122|O3|Outcome|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
171968|NCT01669122|O2|Outcome|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
171969|NCT01669122|O1|Outcome|Test Lozenge (A)|4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
171970|NCT01669122|E4|Reported Event|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
171971|NCT01669122|E3|Reported Event|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
171972|NCT01669122|E2|Reported Event|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
171973|NCT01669122|E1|Reported Event|Test Lozenge (A)|4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
171974|NCT01668836|B5|Baseline|Total|Total of all reporting groups
171975|NCT01668836|B4|Baseline|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
171976|NCT01668836|B3|Baseline|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
171977|NCT01668836|B2|Baseline|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
171978|NCT01668836|B1|Baseline|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
171979|NCT01668836|P4|Participant Flow|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
171980|NCT01668836|P3|Participant Flow|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
171981|NCT01668836|P2|Participant Flow|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
171982|NCT01668836|P1|Participant Flow|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
171983|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
171984|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
171987|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
171988|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
171989|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
171990|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
171991|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
171992|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
171993|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
171994|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
171995|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
171996|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
171997|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
171998|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
171999|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
172000|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
172001|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
172002|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
172003|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
172004|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
172005|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
172006|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
172007|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
172008|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
172009|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
172010|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
172011|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
172012|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
172013|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
172014|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
172015|NCT01668836|O4|Outcome|Women With Caloric Restriction|12 women will follow a 1000Kcal/day of caloric restriction
172016|NCT01668836|O3|Outcome|Men With Caloric Restriction|12 men will follow a 1000Kcal/day of caloric restriction
172017|NCT01668836|O2|Outcome|Women With Resveratrol|12 women will receive a pill with 500mg of resveratrol
172018|NCT01668836|O1|Outcome|Men With Resveratrol|12 men will receive a pill with 500mg of resveratrol
172019|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
172020|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
172021|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
172022|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
172023|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
172024|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
172025|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
172026|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
172027|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
172028|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
172029|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
172030|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
172031|NCT01668836|E4|Reported Event|Women With Caloric Restriction|12 women will follow a 1000Kcal/day of caloric restriction
172032|NCT01668836|E3|Reported Event|Men With Caloric Restriction|12 men will follow a 1000Kcal/day of caloric restriction
172033|NCT01668836|E2|Reported Event|Women With Resveratrol|12 women will receive a pill with 500mg of resveratrol
172034|NCT01668836|E1|Reported Event|Men With Resveratrol|12 men will receive a pill with 500mg of resveratrol
172035|NCT01668797|B3|Baseline|Total|Total of all reporting groups
172036|NCT01668797|B2|Baseline|Phase C - Placebo (Double-Blind Maintenance Phase)|Participants received placebo orally once daily for 52 weeks.
172037|NCT01668797|B1|Baseline|Phase C - Brexpiprazole (Double-Blind Maintenance Phase)|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172038|NCT01668797|P4|Participant Flow|Phase C - Placebo (Double-Blind Maintenance Phase)|Participants received placebo orally once daily for 52 weeks.
172039|NCT01668797|P3|Participant Flow|Phase C - Brexpiprazole (Double-Blind Maintenance Phase)|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172040|NCT01668797|P2|Participant Flow|Phase B (Stabilization Phase)|This single-blind stabilization phase was to titrate participants to a dose of brexpiprazole (1 to 4 mg/day) that would maintain stability of psychotic symptoms over 12 consecutive weeks (within a maximum of 36 weeks), while minimizing tolerability issues.
172041|NCT01668797|P1|Participant Flow|Phase A (Conversion Phase)|The purpose of the open-label conversion phase was 2-fold: 1) to cross-titrate the participants current antipsychotic treatment to brexpiprazole monotherapy over a period of 1 to 4 weeks and 2) to allow washout of prohibited medications in preparation for the stabilization phase.
172042|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172043|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172044|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172045|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172046|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172047|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172048|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172049|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172050|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172051|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172052|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172053|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172054|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172055|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172056|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172057|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172058|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172059|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172060|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172061|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172062|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172063|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172064|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172065|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172066|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172067|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172069|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172070|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172071|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172072|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172073|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172074|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172075|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172076|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172077|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172078|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172079|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172080|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172081|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172082|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172083|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172084|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172085|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172086|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172087|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172088|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172089|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172090|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172091|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172092|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172093|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172094|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172095|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172096|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172097|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172098|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
172099|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172100|NCT01668797|E3|Reported Event|Placebo (Double-blnd Maintenance Phase)|Participants received placebo orally once daily for 52 weeks.
172101|NCT01668797|E2|Reported Event|Brexpiprazole (Double-blind Maintenance Phase)|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
172102|NCT01668797|E1|Reported Event|Single Blind Stabilization Phase|This single-blind stabilization phase was to titrate participants to a dose of brexpiprazole (1 to 4 mg/day) that would maintain stability of psychotic symptoms over 12 consecutive weeks (within a maximum of 36 weeks), while minimizing tolerability issues.
172103|NCT01668784|B3|Baseline|Total|Total of all reporting groups
172104|NCT01668784|B2|Baseline|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
172105|NCT01668784|B1|Baseline|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
172106|NCT01668784|P2|Participant Flow|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
172107|NCT01668784|P1|Participant Flow|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
172108|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
172109|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
172153|NCT01668667|O2|Outcome|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
172110|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
172111|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
172112|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
172113|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
172114|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
172115|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
172116|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
172117|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
172118|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
172119|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
172120|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
172121|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
172122|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
172123|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
172124|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
172125|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
172126|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
172127|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
172128|NCT01668784|E2|Reported Event|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
172129|NCT01668784|E1|Reported Event|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
172130|NCT01668667|B5|Baseline|Total|Total of all reporting groups
172131|NCT01668667|B4|Baseline|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
172132|NCT01668667|B3|Baseline|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
172133|NCT01668667|B2|Baseline|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
172134|NCT01668667|B1|Baseline|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
172135|NCT01668667|P4|Participant Flow|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
172136|NCT01668667|P3|Participant Flow|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
172137|NCT01668667|P2|Participant Flow|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
172138|NCT01668667|P1|Participant Flow|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
172139|NCT01668667|O4|Outcome|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
172140|NCT01668667|O3|Outcome|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
172141|NCT01668667|O2|Outcome|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
172142|NCT01668667|O1|Outcome|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
172143|NCT01668667|O4|Outcome|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
172144|NCT01668667|O3|Outcome|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
172145|NCT01668667|O2|Outcome|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
172146|NCT01668667|O1|Outcome|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
172147|NCT01668667|O4|Outcome|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
172148|NCT01668667|O3|Outcome|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
172149|NCT01668667|O2|Outcome|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
172150|NCT01668667|O1|Outcome|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
172151|NCT01668667|O4|Outcome|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
172152|NCT01668667|O3|Outcome|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
172155|NCT01668667|E4|Reported Event|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PMmatching placebo.
172156|NCT01668667|E3|Reported Event|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
172157|NCT01668667|E2|Reported Event|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
172158|NCT01668667|E1|Reported Event|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
172159|NCT01668654|B1|Baseline|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172160|NCT01668654|P1|Participant Flow|Retigabine/Ezogabine TID|Participants (par.) received retigabine/ezogabine as immediate release (IR) tablets three times a day (TID) as add-on therapy. Six dose strengths (25 milligrams(mg)/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg per day (mg/day) (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172161|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172162|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172163|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172164|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172165|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172166|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172167|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172168|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172210|NCT01668628|O3|Outcome|Prevalent HD Patients|Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
172211|NCT01668628|O2|Outcome|Prevalent PD Patients|Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months
173317|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
172169|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172170|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172171|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172172|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172173|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172174|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172175|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172176|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172177|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172178|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172179|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172239|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172517|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
172180|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172181|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172182|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172183|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172184|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172185|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172186|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172187|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172188|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172189|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172190|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172240|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172518|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
172191|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172192|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172193|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172194|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172195|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172196|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172197|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172198|NCT01668654|E1|Reported Event|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability) over the course of this long-term open-label extension study. Physicians used their clinical judgment in making dose adjustments. Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
172199|NCT01668628|B4|Baseline|Total|Total of all reporting groups
172200|NCT01668628|B3|Baseline|Prevalent HD Patients|Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
172201|NCT01668628|B2|Baseline|Prevalent PD Patients|Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months
172202|NCT01668628|B1|Baseline|Incident PD Patients|First treatment for end stage of renal disease (ESRD) by any peritoneal dialysis modality within 30 days prior to or following enrollment (patients may be enrolled prior to commencing first treatment if there is clear indication that the treatment modality is continuous ambulatory peritoneal dia;ysis (CAPD) or automated peritoneal dialysis (APD) and they consent in advance to enter the study) and patients who don't have any experience of dialysis treatment before this study
172203|NCT01668628|P3|Participant Flow|Prevalent Hemodialysis (HD) Patients|Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
172204|NCT01668628|P2|Participant Flow|Prevalent Peritoneal Dialysis (PD) Patients|Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months
172205|NCT01668628|P1|Participant Flow|Incident Peritoneal Dialysis(PD) Patients|First treatment for end stage of renal disease (ESRD) by any peritoneal dialysis modality within 30 days prior to or following enrollment (patients may be enrolled prior to commencing first treatment if there is clear indication that the treatment modality is continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) and they consent in advance to enter the study) and patients who don't have any experience of dialysis treatment before this study
172206|NCT01668628|O2|Outcome|Overhydration Group|Hemodialysis patients with baseline OH value >+2L
172207|NCT01668628|O1|Outcome|Normohydration Group|Hemodialysis patients with baseline -2L<OH value <+2L
172208|NCT01668628|O2|Outcome|Overhydration Group|Peritoneal dialysis patients with baseline OH value >+2L
172212|NCT01668628|O1|Outcome|Incident PD Patients|First treatment for end stage of renal disease (ESRD) by any peritoneal dialysis modality within 30 days prior to or following enrollment (patients may be enrolled prior to commencing first treatment if there is clear indication that the treatment modality is continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) and they consent in advance to enter the study) and patients who don't have any experience of dialysis treatment before this study
172213|NCT01668628|E3|Reported Event|Prevalent HD Patients|Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
172214|NCT01668628|E2|Reported Event|Prevalent PD Patients|Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months
172215|NCT01668628|E1|Reported Event|Incident PD Patients|First treatment for ESRD by any peritoneal dialysis modality within 30 days prior to or following enrollment (patients may be enrolled prior to commencing first treatment if there is clear indication that the treatment modality is CAPD or APD and they consent in advance to enter the study) and patients who don't have any experience of dialysis treatment before this study
172216|NCT01668589|B5|Baseline|Total|Total of all reporting groups
172217|NCT01668589|B4|Baseline|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172218|NCT01668589|B3|Baseline|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172219|NCT01668589|B2|Baseline|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172220|NCT01668589|B1|Baseline|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172221|NCT01668589|P4|Participant Flow|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172222|NCT01668589|P3|Participant Flow|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172223|NCT01668589|P2|Participant Flow|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172224|NCT01668589|P1|Participant Flow|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172225|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172226|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172227|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172228|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172229|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172230|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172231|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172232|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172233|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172234|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172235|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172236|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172237|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172238|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172404|NCT01667978|O1|Outcome|Protease Inhibitor|"Study group with PI: atazanavir ritonavir~Norethindrone acetate"
172241|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172242|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172243|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172244|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172245|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172246|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172247|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172248|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172249|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172250|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172251|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172252|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172253|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172254|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172255|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172256|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
172257|NCT01668589|E4|Reported Event|Belgium|Prolia 60 mg SC Q6M
172258|NCT01668589|E3|Reported Event|Greece|Prolia 60 mg SC Q6M
172259|NCT01668589|E2|Reported Event|Austria|Prolia 60 mg SC Q6M
172260|NCT01668589|E1|Reported Event|Germany|Prolia 60 mg SC Q6M
172261|NCT01668173|B1|Baseline|All Patients|HSP90 Inhibitor, AUY922, in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), and Refractory PV/ET
172262|NCT01668173|P1|Participant Flow|All Patients|HSP90 Inhibitor, AUY922, in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), and Refractory PV/ET
172263|NCT01668173|O1|Outcome|All Patients|HSP90 Inhibitor, AUY922, in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), and Refractory PV/ET
172264|NCT01668173|E1|Reported Event|All Patients|HSP90 Inhibitor, AUY922, in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), and Refractory PV/ET
172265|NCT01668030|B1|Baseline|All Study Participants|"Double Blind (masked to subject, caregiver, & outcome assessor. Intervention is that either drug is randomized into being applied to either right or left side of face.~Enzymatic treatment versus Bacitracin: Person is their own control. Ointments randomly applied to either side of face."
172266|NCT01668030|P2|Participant Flow|Enzymatic Agent Treatment Side of Face|Enzymatic agent applied to cheek
172267|NCT01668030|P1|Participant Flow|Bacitracin Treated Side of Face|Bacitractin was applied to one side of face.
172268|NCT01668030|O2|Outcome|Enzymatic Agent Treatment Side of Face|"Double Blind (masked to subject, caregiver, & outcome assessor. Intervention is that either drug is randomized into being applied to either right or left side of face.~Enzymatic agent versus Bacitracin: Person is their own control. Ointments randomly applied to either side of face."
172269|NCT01668030|O1|Outcome|Bacitracin Treated Side of Face|"Double Blind (masked to subject, caregiver, & outcome assessor. Intervention is that either drug is randomized into being applied to either right or left side of face.~Enzymatic agent versus Bacitracin: Person is their own control. Ointments randomly applied to either side of face."
172270|NCT01668030|E1|Reported Event|All Study Participants|"Double Blind (masked to subject, caregiver, & outcome assessor. Intervention is that either drug is randomized into being applied to either right or left side of face.~Enzymatic treatment versus Bacitracin: Person is their own control. Ointments randomly applied to either side of face."
172271|NCT01668017|B6|Baseline|Total|Total of all reporting groups
172272|NCT01668017|B5|Baseline|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172273|NCT01668017|B4|Baseline|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172274|NCT01668017|B3|Baseline|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172275|NCT01668017|B2|Baseline|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172276|NCT01668017|B1|Baseline|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21- day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172277|NCT01668017|P5|Participant Flow|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172278|NCT01668017|P4|Participant Flow|Part 1: Pimasertib 30 mg in Hepatocellular Carcinoma (HCC)|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172279|NCT01668017|P3|Participant Flow|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172280|NCT01668017|P2|Participant Flow|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172281|NCT01668017|P1|Participant Flow|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 milligram (mg) twice a day (BID) in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172282|NCT01668017|O5|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172283|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172284|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172285|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172286|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172287|NCT01668017|O5|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172288|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172289|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172290|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172291|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg twice a day (BID) until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172292|NCT01668017|O5|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172293|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172294|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172295|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172296|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172405|NCT01667978|E2|Reported Event|Control|"o PI therapy, control group~Norethindrone acetate"
172297|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172298|NCT01668017|O4|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172299|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172300|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172301|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172302|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172303|NCT01668017|O4|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172304|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172305|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172306|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172307|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172308|NCT01668017|O4|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172309|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172310|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172311|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172312|NCT01668017|O1|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172313|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172314|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172315|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172316|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172317|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172318|NCT01668017|O4|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172319|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172320|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172321|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172406|NCT01667978|E1|Reported Event|Protease Inhibitor|"Study group with PI: atazanavir ritonavir~Norethindrone acetate"
172322|NCT01668017|O1|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172323|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172324|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with HCC were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172325|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172326|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172327|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172328|NCT01668017|O4|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172329|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172330|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172331|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172332|NCT01668017|O1|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172333|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172334|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172335|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172336|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172337|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172338|NCT01668017|O4|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172339|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172340|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172341|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 milligram (mg) twice a day (BID) in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172342|NCT01668017|O1|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172343|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172344|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172345|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172346|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172407|NCT01667926|B3|Baseline|Total|Total of all reporting groups
172408|NCT01667926|B2|Baseline|Placebo|"Subjects will receive 6 infusions of normal saline over 3 weeks.~Placebo"
172347|NCT01668017|O1|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172348|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172349|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172350|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172351|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172352|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172353|NCT01668017|O4|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172354|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172355|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172356|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172357|NCT01668017|O1|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172358|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172359|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172360|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172361|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172362|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172363|NCT01668017|O4|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172364|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172365|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172366|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172367|NCT01668017|O1|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172368|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172369|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172370|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172371|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172470|NCT01667900|O3|Outcome|1.5 mg Dulaglutide (Part A-Healthy)|1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
172372|NCT01668017|O5|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172373|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172374|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172375|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172376|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172377|NCT01668017|O5|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject, whichever comes first.
172378|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject, whichever comes first.
172379|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject, whichever comes first.
172380|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172381|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172382|NCT01668017|E5|Reported Event|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172383|NCT01668017|E4|Reported Event|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172384|NCT01668017|E3|Reported Event|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172385|NCT01668017|E2|Reported Event|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172386|NCT01668017|E1|Reported Event|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
172387|NCT01668004|B1|Baseline|GLM 50 mg|GLM given subcutaneously at a dose of 50 mg once monthly for up to 12 months
172388|NCT01668004|P1|Participant Flow|GLM 50 mg|Golimumab (GLM) given subcutaneously at a dose of 50 mg once monthly for up to 12 months
172389|NCT01668004|O1|Outcome|GLM 50 mg|GLM given subcutaneously at a dose of 50 mg once monthly for up to 12 months
172390|NCT01668004|O1|Outcome|GLM 50 mg|GLM given subcutaneously at a dose of 50 mg once monthly for up to 12 months
172391|NCT01668004|O2|Outcome|After GLM Treatment Start|GLM observation period: Prospective follow-up of participants given GLM subcutaneously at a dose of 50 mg once monthly for up to 12 months
172392|NCT01668004|O1|Outcome|Before Initial Anti-TNF/GLM Treatment|Historical observation period: Retrospective record review over the 12 months prior to the initial anti-TNF treatment (anti-TNF experienced participants) or the first GLM dose (anti-TNF naïve participants).
172393|NCT01668004|O2|Outcome|After GLM Treatment Start|GLM observation period: Prospective follow-up of participants given GLM subcutaneously at a dose of 50 mg once monthly for up to 12 months
172394|NCT01668004|O1|Outcome|Before Initial Anti-TNF/GLM Treatment|Historical observation period: Retrospective record review over the 12 months prior to the initial anti-TNF treatment (anti-TNF experienced participants) or the first GLM dose (anti-TNF naïve participants).
172395|NCT01668004|O2|Outcome|After GLM Treatment Start|GLM observation period: Prospective follow-up of participants given GLM subcutaneously at a dose of 50 mg once monthly for up to 12 months
172396|NCT01668004|O1|Outcome|Before Initial Anti-TNF/GLM Treatment|Historical observation period: Retrospective record review over the 12 months prior to the initial anti-TNF treatment (anti-TNF experienced participants) or the first GLM dose (anti-TNF naïve participants).
172397|NCT01668004|E1|Reported Event|GLM 50 mg|GLM given subcutaneously at a dose of 50 mg once monthly for up to 12 months
172398|NCT01667978|B3|Baseline|Total|Total of all reporting groups
172399|NCT01667978|B2|Baseline|Control|"o PI therapy, control group~Norethindrone acetate"
172400|NCT01667978|B1|Baseline|Protease Inhibitor|"Study group with PI: atazanavir ritonavir~Norethindrone acetate"
172401|NCT01667978|P2|Participant Flow|Control|"no PI therapy, control group~Norethindrone acetate~17 controls (4 no ARV)"
172402|NCT01667978|P1|Participant Flow|Protease Inhibitor|"Study group with PI: atazanavir ritonavir~Norethindrone acetate~16 HIV positive on PI (atazanavir ritonavir 10, darunovir, lopinavir)"
172403|NCT01667978|O2|Outcome|Control|"o PI therapy, control group~Norethindrone acetate"
172409|NCT01667926|B1|Baseline|Ketamine|"Subject will receive 6 infusions of ketamine over three weeks.~Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen."
172410|NCT01667926|P3|Participant Flow|Screen Fail/No Baseline|"Participants who signed informed consent and were screened but did not meet study inclusion/exclusion criteria.~Participants in the screen fail group were not randomized to either Ketamine nor placebo and did not receive any infusions."
172411|NCT01667926|P2|Participant Flow|Placebo|"Subjects will receive 6 infusions of normal saline over 3 weeks.~Placebo"
172412|NCT01667926|P1|Participant Flow|Ketamine|"Subject will receive 6 infusions of ketamine over three weeks.~Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen."
172413|NCT01667926|O2|Outcome|Placebo|"Subjects will receive 6 infusions of normal saline over 3 weeks.~Placebo"
172414|NCT01667926|O1|Outcome|Ketamine|"Subject will receive 6 infusions of ketamine over three weeks.~Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen."
172415|NCT01667926|O2|Outcome|Placebo|"Subjects will receive 6 infusions of normal saline over 3 weeks.~Placebo"
172416|NCT01667926|O1|Outcome|Ketamine|"Subject will receive 6 infusions of ketamine over three weeks.~Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen."
172417|NCT01667926|E2|Reported Event|Placebo|"Subjects will receive 6 infusions of normal saline over 3 weeks.~Placebo"
172418|NCT01667926|E1|Reported Event|Ketamine|"Subject will receive 6 infusions of ketamine over three weeks.~Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen."
172419|NCT01667900|B6|Baseline|Total|Total of all reporting groups
172420|NCT01667900|B5|Baseline|Placebo (Part B-T2DM)|Placebo administered to participants with T2DM once weekly SQ for 4 weeks in Part B
172421|NCT01667900|B4|Baseline|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
172422|NCT01667900|B3|Baseline|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
172423|NCT01667900|B2|Baseline|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
172424|NCT01667900|B1|Baseline|Part A-Healthy|Part A (single-dose, 3 treatment period, crossover design) involved overtly healthy participants only. Each participant received single doses of placebo and 2 of the 3 dulaglutide doses (0.5, 0.75, and 1.5 mg), in 3 treatment periods, such that placebo was administered SQ to all 16 participants and 0.5, 0.75, and 1.5 mg dulaglutide was administered SQ to 10, 11, and 11 participants, respectively. There was a washout period of at least 28 days between doses.
172425|NCT01667900|P20|Participant Flow|Placebo (Part B-T2DM)|Placebo administered to participants with T2DM once weekly SQ for 4 weeks in Part B
172426|NCT01667900|P19|Participant Flow|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
172427|NCT01667900|P18|Participant Flow|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
172428|NCT01667900|P17|Participant Flow|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM) once weekly SQ for 4 weeks in Part B
172429|NCT01667900|P16|Participant Flow|First Placebo, Then 1.5 mg, Then 0.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: placebo administered once SQ~Period 2: 1.5 mg dulaglutide administered once SQ~Period 3: 0.5 mg dulaglutide administered once SQ"
172430|NCT01667900|P15|Participant Flow|First 1.5 mg, Then 0.5 mg, Then Placebo (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 1.5 mg dulaglutide administered once SQ~Period 2: 0.5 mg dulaglutide administered once SQ~Period 3: placebo administered once SQ"
172431|NCT01667900|P14|Participant Flow|First Placebo, Then 1.5 mg, Then 0.75 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: placebo administered once SQ~Period 2: 1.5 mg dulaglutide administered once SQ~Period 3: 0.75 mg dulaglutide administered once SQ"
172432|NCT01667900|P13|Participant Flow|First 0.75 mg, Then Placebo, Then 0.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.75 mg dulaglutide administered once SQ~Period 2: placebo administered once SQ~Period 3: 0.5 mg dulaglutide administered once SQ"
172433|NCT01667900|P12|Participant Flow|First 0.5 mg, Then Placebo, Then 0.75 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.5 mg dulaglutide administered once SQ~Period 2: placebo administered once SQ~Period 3: 0.75 mg dulaglutide administered once SQ"
172434|NCT01667900|P11|Participant Flow|First 1.5 mg, Then 0.75 mg, Then Placebo (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 1.5 mg dulaglutide administered once SQ~Period 2: 0.75 mg dulaglutide administered once SQ~Period 3: placebo administered once SQ"
172435|NCT01667900|P10|Participant Flow|First 0.5 mg, Then 0.75 mg, Then Placebo (Part A-Helathy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.5 mg dulaglutide administered once SQ~Period 2: 0.75 mg dulaglutide administered once SQ~Period 3: placebo administered once SQ"
172436|NCT01667900|P9|Participant Flow|First Placebo, Then 0.75 mg, Then 1.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: placebo administered once SQ~Period 2: 0.75 mg dulaglutide administered once SQ~Period 3: 1.5 mg dulaglutide administered once SQ"
172471|NCT01667900|O2|Outcome|0.75 mg Dulaglutide (Part A-Healthy)|0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
172472|NCT01667900|O1|Outcome|0.5 mg Dulaglutide (Part A-Healthy)|0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
172437|NCT01667900|P8|Participant Flow|First Placebo, Then 0.75 mg, Then 0.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: placebo administered once SQ~Period 2: 0.75 mg dulaglutide administered once SQ~Period 3: 0.5 mg dulaglutide administered once SQ"
172438|NCT01667900|P7|Participant Flow|First 0.75 mg, Then Placebo, Then 1.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.75 mg dulaglutide administered once SQ~Period 2: placebo administered once SQ~Period 3: 1.5 mg dulaglutide administered once SQ"
172439|NCT01667900|P6|Participant Flow|First Placebo, Then 0.5 mg, Then 1.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: placebo administered once SQ~Period 2: 0.5 mg dulaglutide administered once SQ~Period 3: 1.5 mg dulaglutide administered once SQ"
172440|NCT01667900|P5|Participant Flow|First 1.5 mg, Then Placebo, Then 0.75 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 1.5 mg dulaglutide administered once SQ~Period 2: placebo administered once SQ~Period 3: 0.75 mg dulaglutide administered once SQ"
172441|NCT01667900|P4|Participant Flow|First 0.5 mg, Then 1.5 mg, Then Placebo (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.5 mg dulaglutide administered once SQ~Period 2: 1.5 mg dulaglutide administered once SQ~Period 3: placebo administered once SQ"
172442|NCT01667900|P3|Participant Flow|First 0.75 mg, Then 1.5 mg, Then Placebo (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.75 mg dulaglutide administered once SQ~Period 2: 1.5 mg dulaglutide administered once SQ~Period 3: placebo administered once SQ"
172443|NCT01667900|P2|Participant Flow|First 0.75 mg, Then 0.5 mg, Then Placebo (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.75 mg dulaglutide administered once SQ~Period 2: 0.5 mg dulaglutide administered once SQ~Period 3: placebo administered once SQ"
172444|NCT01667900|P1|Participant Flow|First 0.5 mg, Then Placebo, Then 1.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.5 milligrams (mg) dulaglutide administered once subcutaneously (SQ)~Period 2: placebo administered once SQ~Period 3: 1.5 mg dulaglutide administered once SQ"
172445|NCT01667900|O4|Outcome|Placebo (Part B-T2DM|Placebo administered to participants with T2DM once weekly SQ for 4 weeks in Part B
172446|NCT01667900|O3|Outcome|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
172447|NCT01667900|O2|Outcome|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
172448|NCT01667900|O1|Outcome|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
172449|NCT01667900|O6|Outcome|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
172450|NCT01667900|O5|Outcome|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
172451|NCT01667900|O4|Outcome|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
172452|NCT01667900|O3|Outcome|1.5 mg Dulaglutide (Part A-Healthy)|1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
172453|NCT01667900|O2|Outcome|0.75 mg Dulaglutide (Part A-Healthy)|0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
172454|NCT01667900|O1|Outcome|0.5 mg Dulaglutide (Part A-Healthy)|0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
172455|NCT01667900|O6|Outcome|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
172456|NCT01667900|O5|Outcome|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
172457|NCT01667900|O4|Outcome|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
172458|NCT01667900|O3|Outcome|1.5 mg Dulaglutide (Part A-Healthy)|1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
172459|NCT01667900|O2|Outcome|0.75 mg Dulaglutide (Part A-Healthy)|0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
172460|NCT01667900|O1|Outcome|0.5 mg Dulaglutide (Part A-Healthy)|0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
172461|NCT01667900|O6|Outcome|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
172462|NCT01667900|O5|Outcome|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
172463|NCT01667900|O4|Outcome|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
172464|NCT01667900|O3|Outcome|1.5 mg Dulaglutide (Part A-Healthy)|1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
172465|NCT01667900|O2|Outcome|0.75 mg Dulaglutide (Part A-Healthy)|0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
172466|NCT01667900|O1|Outcome|0.5 mg Dulaglutide (Part A-Healthy)|0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
172467|NCT01667900|O6|Outcome|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
172468|NCT01667900|O5|Outcome|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
172469|NCT01667900|O4|Outcome|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
172473|NCT01667900|E8|Reported Event|1.5 mg Dulaglutide (Part B-T2DM)|"1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks~Dulaglutide~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
172474|NCT01667900|E7|Reported Event|0.75 mg Dulaglutide (Part B-T2DM)|"0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks~Dulaglutide~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
172475|NCT01667900|E6|Reported Event|0.5 mg Dulaglutide (Part B-T2DM)|"0.5 mg dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM) once weekly SQ for 4 weeks~Dulaglutide~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
172476|NCT01667900|E5|Reported Event|Placebo (Part B-T2DM)|"Placebo administered to participants with T2DM once weekly SQ for 4 weeks~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
172477|NCT01667900|E4|Reported Event|1.5 mg Dulaglutide (Part A-Healthy)|"1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods~Dulaglutide~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
172478|NCT01667900|E3|Reported Event|0.75 mg Dulaglutide (Part A-Healthy)|"0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods~Dulaglutide~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
172479|NCT01667900|E2|Reported Event|0.5 mg Dulaglutide (Part A-Healthy)|"0.5 milligrams (mg) dulaglutide administered once subcutaneously (SQ) to healthy participants in 1 of 3 treatment periods~Dulaglutide~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
172480|NCT01667900|E1|Reported Event|Placebo (Part A-Healthy)|"Placebo administered once SQ to healthy participants in 1 of 3 treatment periods~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
172481|NCT01667848|B3|Baseline|Total|Total of all reporting groups
172482|NCT01667848|B2|Baseline|Group B|Insufflation with warm gas during laparoskopic cholecystectomy
172483|NCT01667848|B1|Baseline|Group A: Insufflation With Cold Gas|Insufflation with cold gas during laparoskopic cholecystectomy
172484|NCT01667848|P2|Participant Flow|Group B: Insufflation With Warm Gas|Insufflation with warm gas during laparoscopic cholecystectomy
172485|NCT01667848|P1|Participant Flow|Group A: Insufflation With Cold Gas|Insufflation with cold gas during laparoskopic cholecystectomy
172486|NCT01667848|O2|Outcome|Group B|Insufflation with warm gas during laparoskopic cholecystectomy
172487|NCT01667848|O1|Outcome|Group A: Insufflation With Cold Gas|Insufflation with cold gas during laparoskopic cholecystectomy
172488|NCT01667848|O2|Outcome|Group B|Insufflation with warm gas during laparoskopic cholecystectomy
172489|NCT01667848|O1|Outcome|Group A: Insufflation With Cold Gas|Insufflation with cold gas during laparoskopic cholecystectomy
172490|NCT01667848|E2|Reported Event|Group B|Insufflation with warm gas during laparoscopic cholecystectomy
172491|NCT01667848|E1|Reported Event|Group A|Insufflation with cold gas during laparoscopic cholecystectomy
172492|NCT01667796|B3|Baseline|Total|Total of all reporting groups
172493|NCT01667796|B2|Baseline|Healthy Controls|Female subjects without MS
172494|NCT01667796|B1|Baseline|MS Subjects|Female subjects with MS
172495|NCT01667796|P2|Participant Flow|Healthy Controls|Healthy control subjects
172496|NCT01667796|P1|Participant Flow|MS Subjects|MS patients
172497|NCT01667796|O2|Outcome|Healthy Controls|Female subjects without MS
172498|NCT01667796|O1|Outcome|MS Subjects|Female subjects with MS
172499|NCT01667796|E2|Reported Event|Healthy Controls|Healthy control subjects
172500|NCT01667796|E1|Reported Event|MS Subjects|MS patients
172501|NCT01667731|B6|Baseline|Total|Total of all reporting groups
172502|NCT01667731|B5|Baseline|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
172503|NCT01667731|B4|Baseline|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
172504|NCT01667731|B3|Baseline|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
172505|NCT01667731|B2|Baseline|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
172506|NCT01667731|B1|Baseline|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
172507|NCT01667731|P5|Participant Flow|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
172508|NCT01667731|P4|Participant Flow|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
172509|NCT01667731|P3|Participant Flow|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced (TE), genotype 2)
172510|NCT01667731|P2|Participant Flow|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
172511|NCT01667731|P1|Participant Flow|SOF+RBV 12 Wk GT 2 TN|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive (TN), genotype (GT) 2)
172512|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
172513|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
172514|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
172515|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
172516|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
172519|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
172520|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
172521|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
172522|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
172523|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
172524|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
172525|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
172526|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
172527|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
172528|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
172529|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
172530|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
172531|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
172532|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
172533|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
172534|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
172535|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
172536|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
172537|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
172538|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
172539|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
172540|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
172541|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
172542|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
172543|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
172544|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
172545|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
172546|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
172547|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
172548|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
172549|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
172550|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
172551|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
172552|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
172553|NCT01667731|O2|Outcome|SOF+RBV 24 Wk GT 2/3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotypes 2 and 3)
172554|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2/3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotypes 2 and 3)
172555|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
172556|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
172557|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
172558|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
172559|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
172560|NCT01667731|E3|Reported Event|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
172561|NCT01667731|E2|Reported Event|SOF+RBV 24 Wk GT 2/3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotypes 2 and 3)
172562|NCT01667731|E1|Reported Event|SOF+RBV 12 Wk GT 2/3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotypes 2 and 3)
172563|NCT01667679|B3|Baseline|Total|Total of all reporting groups
172564|NCT01667679|B2|Baseline|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1, participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally.
172565|NCT01667679|B1|Baseline|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1, participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril.
172566|NCT01667679|P2|Participant Flow|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172567|NCT01667679|P1|Participant Flow|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period (TP) 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172568|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172569|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172570|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172571|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172622|NCT01667679|E2|Reported Event|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
172623|NCT01667679|E1|Reported Event|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
172624|NCT01667536|B1|Baseline|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
172572|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172573|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172574|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172575|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172576|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172577|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172578|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172579|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172580|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172625|NCT01667536|P1|Participant Flow|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
172626|NCT01667536|O2|Outcome|Drug: 99mTc-MIP-1404 + MRI|Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on MRI imaging.
172722|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
172581|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172582|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172583|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172584|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172585|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172586|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172587|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172588|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172589|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172627|NCT01667536|O1|Outcome|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on 99mTc-MIP-1404 imaging."
172628|NCT01667536|O2|Outcome|Drug: 99mTc-MIP-1404 + MRI|Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on MRI imaging.
172723|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
172590|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172591|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172592|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172593|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172594|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172595|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172596|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172597|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172598|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172629|NCT01667536|O1|Outcome|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on 99mTc-MIP-1404 imaging."
172630|NCT01667536|O1|Outcome|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
173318|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
172599|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172600|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172601|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172602|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172603|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
172604|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
172605|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
172606|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
172607|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
172608|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
172609|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
172610|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
172611|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
172612|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
172613|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
172614|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
172615|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
172616|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
172617|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
172618|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
172619|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
172620|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
172621|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
172631|NCT01667536|O1|Outcome|Drug: 99mTc-MIP-1404|20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404 Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
172632|NCT01667536|O1|Outcome|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
172633|NCT01667536|O1|Outcome|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
172634|NCT01667536|E1|Reported Event|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
172635|NCT01667471|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
172636|NCT01667471|P1|Participant Flow|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg intravenously (IV) every 4 weeks up to 104 weeks or until tocilizumab was commercially available for polyarticular-course Juvenile Idiopathic Arthritis (pcJIA).
172637|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
172638|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
172639|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
172640|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
172641|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
172642|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
172643|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
172644|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
172645|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
172646|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
172647|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
172648|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
172649|NCT01667471|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
172650|NCT01667471|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
172651|NCT01667432|B1|Baseline|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.
172652|NCT01667432|P1|Participant Flow|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.
172653|NCT01667432|O1|Outcome|Peginterferon Alfa-2a|Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.
172654|NCT01667432|O1|Outcome|Peginterferon Alfa-2a|Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.
172655|NCT01667432|E1|Reported Event|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.
172656|NCT01667224|B3|Baseline|Total|Total of all reporting groups
172657|NCT01667224|B2|Baseline|Placebo|"Placebo(450mg/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Actiponin."
172658|NCT01667224|B1|Baseline|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks~Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
172659|NCT01667224|P2|Participant Flow|Placebo|"Placebo(450mg/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Actiponin."
172660|NCT01667224|P1|Participant Flow|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks~Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
172661|NCT01667224|O2|Outcome|Placebo (450mg/Day) for 12 Week|Placebo: Amount and calorie of placebo are same with Actiponin
172662|NCT01667224|O1|Outcome|Actiponin(450mg/Day) for 12week|Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material.
172663|NCT01667224|O2|Outcome|Placebo|"Placebo(450mg/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Actiponin."
172664|NCT01667224|O1|Outcome|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks~Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
172665|NCT01667224|O2|Outcome|Placebo|"Placebo(450mg/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Actiponin."
172666|NCT01667224|O1|Outcome|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks~Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
172667|NCT01667224|O2|Outcome|Placebo|"Placebo(450mg/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Actiponin."
172668|NCT01667224|O1|Outcome|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks~Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
172669|NCT01667224|E2|Reported Event|Placebo|"Placebo(450mg/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Actiponin."
172670|NCT01667224|E1|Reported Event|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks~Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
172671|NCT01667107|B3|Baseline|Total|Total of all reporting groups
172672|NCT01667107|B2|Baseline|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
172673|NCT01667107|B1|Baseline|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
172674|NCT01667107|P2|Participant Flow|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
172675|NCT01667107|P1|Participant Flow|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
172676|NCT01667107|O2|Outcome|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
172677|NCT01667107|O1|Outcome|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
172678|NCT01667107|O2|Outcome|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
172679|NCT01667107|O1|Outcome|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
172680|NCT01667107|O2|Outcome|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
172681|NCT01667107|O1|Outcome|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
172682|NCT01667107|O2|Outcome|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
172683|NCT01667107|O1|Outcome|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
172721|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
183883|NCT01627002|E7|Reported Event|Part B PA401 1.0 mg|
172684|NCT01667107|O2|Outcome|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
172685|NCT01667107|O1|Outcome|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
172686|NCT01667107|O2|Outcome|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
172687|NCT01667107|O1|Outcome|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
172688|NCT01667107|E2|Reported Event|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
172689|NCT01667107|E1|Reported Event|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
172690|NCT01666951|B3|Baseline|Total|Total of all reporting groups
172691|NCT01666951|B2|Baseline|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
172692|NCT01666951|B1|Baseline|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
172693|NCT01666951|P2|Participant Flow|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
172694|NCT01666951|P1|Participant Flow|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
172695|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
172696|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
172697|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
172698|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
172699|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
172700|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
172701|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
172702|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
172703|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
172704|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
172705|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
172706|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
172707|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
172708|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
172709|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
172710|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
172711|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
172712|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
172713|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
172714|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
172715|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
172716|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
172717|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
172718|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
172719|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
172720|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
172724|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
172725|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
172726|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
172727|NCT01666951|E2|Reported Event|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
172728|NCT01666951|E1|Reported Event|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
172729|NCT01666912|B3|Baseline|Total|Total of all reporting groups
172730|NCT01666912|B2|Baseline|Immediate Postpartum Contraceptive Implant|"randomized to receive contraceptive implant prior to leaving the hospital postpartum~Contraceptive implant"
172731|NCT01666912|B1|Baseline|6 Week Postpartum Contraceptive Implant|"randomized to receive contraceptive implant at normal 6 week postpartum visit~Contraceptive implant"
172732|NCT01666912|P2|Participant Flow|Immediate Postpartum Contraceptive Implant|"randomized to receive contraceptive implant prior to leaving the hospital postpartum~Contraceptive implant"
172733|NCT01666912|P1|Participant Flow|6 Week Postpartum Contraceptive Implant|"randomized to receive contraceptive implant at normal 6 week postpartum visit~Contraceptive implant"
172734|NCT01666912|O2|Outcome|Immediate Postpartum Contraceptive Implant|"randomized to receive contraceptive implant prior to leaving the hospital postpartum~Contraceptive implant"
172735|NCT01666912|O1|Outcome|6 Week Postpartum Contraceptive Implant|"randomized to receive contraceptive implant at normal 6 week postpartum visit~Contraceptive implant"
172736|NCT01666912|O2|Outcome|Immediate Postpartum Contraceptive Implant|"randomized to receive contraceptive implant prior to leaving the hospital postpartum~Contraceptive implant"
172737|NCT01666912|O1|Outcome|6 Week Postpartum Contraceptive Implant|"randomized to receive contraceptive implant at normal 6 week postpartum visit~Contraceptive implant"
172738|NCT01666912|O2|Outcome|Immediate Postpartum Contraceptive Implant|"randomized to receive contraceptive implant prior to leaving the hospital postpartum~Contraceptive implant"
172739|NCT01666912|O1|Outcome|6 Week Postpartum Contraceptive Implant|"randomized to receive contraceptive implant at normal 6 week postpartum visit~Contraceptive implant"
172740|NCT01666912|E2|Reported Event|Immediate Postpartum Contraceptive Implant|"randomized to receive contraceptive implant prior to leaving the hospital postpartum~Contraceptive implant"
172741|NCT01666912|E1|Reported Event|6 Week Postpartum Contraceptive Implant|"randomized to receive contraceptive implant at normal 6 week postpartum visit~Contraceptive implant"
172742|NCT01666782|B3|Baseline|Total|Total of all reporting groups
172743|NCT01666782|B2|Baseline|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
172744|NCT01666782|B1|Baseline|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
172745|NCT01666782|P2|Participant Flow|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
172746|NCT01666782|P1|Participant Flow|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
172747|NCT01666782|O2|Outcome|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
172748|NCT01666782|O1|Outcome|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
172749|NCT01666782|O2|Outcome|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
172750|NCT01666782|O1|Outcome|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
172751|NCT01666782|O2|Outcome|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
172752|NCT01666782|O1|Outcome|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
172753|NCT01666782|O2|Outcome|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
172754|NCT01666782|O1|Outcome|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
172906|NCT01666119|O1|Outcome|BEMA Buprenorphine/NX Films|BEMA Buprenorphine/NX films (3.5/0.6mg, 5.25/0.9mg, 7.0/1.2mg, 10.5/1.7mg, 14.0/2.3mg)
183884|NCT01627002|E6|Reported Event|Part A Placebo|
172755|NCT01666782|O2|Outcome|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
172756|NCT01666782|O1|Outcome|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
172757|NCT01666782|O2|Outcome|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
172758|NCT01666782|O1|Outcome|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
172759|NCT01666782|E2|Reported Event|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
172760|NCT01666782|E1|Reported Event|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
172761|NCT01666314|B9|Baseline|Total|Total of all reporting groups
172762|NCT01666314|B8|Baseline|Orteronel 400 mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172763|NCT01666314|B7|Baseline|Placebo + Orteronel 400 mg (Ex-Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172764|NCT01666314|B6|Baseline|Orteronel 200 mg (Ex-Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172765|NCT01666314|B5|Baseline|Placebo + Orteronel 200 mg (Ex-Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles outside of Japan (Ex-Japan) for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172766|NCT01666314|B4|Baseline|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172767|NCT01666314|B3|Baseline|Placebo + Orteronel 300 mg (Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172768|NCT01666314|B2|Baseline|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172769|NCT01666314|B1|Baseline|Placebo + Orteronel 200 mg (Japan)|Orteronel placebo-matching tablets, orally, twice daily (BID) in Cycle 1 (28 days) followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily continuously throughout the study.
172770|NCT01666314|P4|Participant Flow|Placebo + Orteronel 400 mg (Ex-Japan)|Orteronel placebo-matching tablets, or Orteronel 400 mg, tablets, orally, twice daily in Cycle 1 followed by orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172771|NCT01666314|P3|Participant Flow|Placebo + Orteronel 200 mg (Ex-Japan)|Orteronel placebo-matching tablets, or Orteronel 200 mg, tablets, orally, twice daily in Cycle 1 followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles outside of Japan (Ex-Japan) for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172772|NCT01666314|P2|Participant Flow|Placebo + Orteronel 300 mg (Japan)|Orteronel placebo-matching tablets or Orteronel 300 mg, tablets, orally, twice daily in Cycle 1 followed by orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172773|NCT01666314|P1|Participant Flow|Placebo + Orteronel 200 mg (Japan)|Orteronel placebo-matching tablets or Orteronel 200 mg, tablets, orally, twice daily (BID) in Cycle 1 (28 days) followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily continuously throughout the study.
172774|NCT01666314|O6|Outcome|Orteronel 400 mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172775|NCT01666314|O5|Outcome|Orteronel 200 mg (Ex-Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
173319|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
172776|NCT01666314|O4|Outcome|Placebo (Ex-Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172777|NCT01666314|O3|Outcome|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172778|NCT01666314|O2|Outcome|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan and ex-Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172779|NCT01666314|O1|Outcome|Placebo (Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172780|NCT01666314|O4|Outcome|Orteronel 400 mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172781|NCT01666314|O3|Outcome|Orteronel 200 mg (Ex-Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172782|NCT01666314|O2|Outcome|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172783|NCT01666314|O1|Outcome|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172784|NCT01666314|O4|Outcome|Orteronel 400 mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172785|NCT01666314|O3|Outcome|Orteronel 200 mg (Ex-Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172786|NCT01666314|O2|Outcome|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172787|NCT01666314|O1|Outcome|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172788|NCT01666314|O4|Outcome|Orteronel 400 mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172789|NCT01666314|O3|Outcome|Orteronel 200 mg (Ex-Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172790|NCT01666314|O2|Outcome|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172791|NCT01666314|O1|Outcome|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172792|NCT01666314|O4|Outcome|Orteronel 400 mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172793|NCT01666314|O3|Outcome|Orteronel 200 mg (Ex-Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172794|NCT01666314|O2|Outcome|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172795|NCT01666314|O1|Outcome|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172796|NCT01666314|O4|Outcome|Orteronel 400 mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172797|NCT01666314|O3|Outcome|Orteronel 200 mg (Ex-Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172798|NCT01666314|O2|Outcome|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172799|NCT01666314|O1|Outcome|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172800|NCT01666314|O4|Outcome|Orteronel 400 mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172801|NCT01666314|O3|Outcome|Orteronel 200 mg (Ex-Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172802|NCT01666314|O2|Outcome|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172803|NCT01666314|O1|Outcome|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172804|NCT01666314|O4|Outcome|Orteronel 400 mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172805|NCT01666314|O3|Outcome|Orteronel 200 mg (Ex-Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172806|NCT01666314|O2|Outcome|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172807|NCT01666314|O1|Outcome|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172808|NCT01666314|O4|Outcome|Orteronel 400 mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172809|NCT01666314|O3|Outcome|Orteronel 200 mg (Ex-Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172810|NCT01666314|O2|Outcome|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172811|NCT01666314|O1|Outcome|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172812|NCT01666314|O4|Outcome|Orteronel 400 mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172813|NCT01666314|O3|Outcome|Orteronel 200 mg (Ex-Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172814|NCT01666314|O2|Outcome|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172815|NCT01666314|O1|Outcome|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172816|NCT01666314|O6|Outcome|Orteronel 400 mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172817|NCT01666314|O5|Outcome|Orteronel 200 mg (Ex-Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172818|NCT01666314|O4|Outcome|Placebo (Ex-Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172819|NCT01666314|O3|Outcome|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172820|NCT01666314|O2|Outcome|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172821|NCT01666314|O1|Outcome|Placebo (Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172822|NCT01666314|O6|Outcome|Orteronel 400 mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172823|NCT01666314|O5|Outcome|Orteronel 200 mg (Ex-Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172824|NCT01666314|O4|Outcome|Placebo (Ex-Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172825|NCT01666314|O3|Outcome|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172826|NCT01666314|O2|Outcome|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172827|NCT01666314|O1|Outcome|Placebo (Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172828|NCT01666314|O6|Outcome|Orteronel 400 mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172829|NCT01666314|O5|Outcome|Orteronel 200 mg (Ex-Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172830|NCT01666314|O4|Outcome|Placebo (Ex-Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172831|NCT01666314|O3|Outcome|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172832|NCT01666314|O2|Outcome|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172833|NCT01666314|O1|Outcome|Placebo (Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172834|NCT01666314|O6|Outcome|Orteronel 400 mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172835|NCT01666314|O5|Outcome|Orteronel 200 mg (Ex-Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172836|NCT01666314|O4|Outcome|Placebo (Ex-Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172837|NCT01666314|O3|Outcome|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172838|NCT01666314|O2|Outcome|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172839|NCT01666314|O1|Outcome|Placebo (Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172840|NCT01666314|O6|Outcome|Orteronel 400 mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172841|NCT01666314|O5|Outcome|Orteronel 200 mg (Ex-Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172842|NCT01666314|O4|Outcome|Placebo (Ex-Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172843|NCT01666314|O3|Outcome|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172844|NCT01666314|O2|Outcome|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172845|NCT01666314|O1|Outcome|Placebo (Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172846|NCT01666314|O6|Outcome|Orteronel 400 mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172847|NCT01666314|O5|Outcome|Orteronel 200 mg (Ex-Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
173056|NCT01665157|B3|Baseline|Low-residue Diet (Enimaclin®) Package and 1.5L PEG|Low-residue diet package with normal amount of 1.5L PEG-ELS
172848|NCT01666314|O4|Outcome|Placebo (Ex-Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172849|NCT01666314|O3|Outcome|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172850|NCT01666314|O2|Outcome|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172851|NCT01666314|O1|Outcome|Placebo (Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172852|NCT01666314|O4|Outcome|Orteronel 400 mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172853|NCT01666314|O3|Outcome|Orteronel 200 mg (Ex-Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172854|NCT01666314|O2|Outcome|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172855|NCT01666314|O1|Outcome|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172856|NCT01666314|O6|Outcome|Orteronel 400 mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172857|NCT01666314|O5|Outcome|Orteronel 200 mg (Ex-Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172858|NCT01666314|O4|Outcome|Placebo (Ex-Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172859|NCT01666314|O3|Outcome|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172860|NCT01666314|O2|Outcome|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172861|NCT01666314|O1|Outcome|Placebo (Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172862|NCT01666314|O4|Outcome|Orteronel 400 mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172863|NCT01666314|O3|Outcome|Orteronel 200 mg (Ex-Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172864|NCT01666314|O2|Outcome|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172865|NCT01666314|O1|Outcome|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172866|NCT01666314|O6|Outcome|Orteronel 400 mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172867|NCT01666314|O5|Outcome|Orteronel 200 mg (Ex-Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172868|NCT01666314|O4|Outcome|Placebo (Ex-Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172869|NCT01666314|O3|Outcome|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172870|NCT01666314|O2|Outcome|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172871|NCT01666314|O1|Outcome|Placebo (Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
173057|NCT01665157|B2|Baseline|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount of 2L PEG-ELS
172872|NCT01666314|O2|Outcome|Orteronel 400 mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172873|NCT01666314|O1|Outcome|Placebo (Ex-Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172874|NCT01666314|O2|Outcome|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172875|NCT01666314|O1|Outcome|Placebo (Japan)|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172876|NCT01666314|E5|Reported Event|Orteronel 400mg (Ex-Japan)|Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172877|NCT01666314|E4|Reported Event|Orteronel 200 mg (Ex-Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172878|NCT01666314|E3|Reported Event|Orteronel 300 mg (Japan)|Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172879|NCT01666314|E2|Reported Event|Orteronel 200 mg (Japan)|Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172880|NCT01666314|E1|Reported Event|Placebo|Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
172881|NCT01666210|B3|Baseline|Total|Total of all reporting groups
172882|NCT01666210|B2|Baseline|Placebo Vehicle Punctum Plug|"Placebo punctum plug insertion~Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone"
172883|NCT01666210|B1|Baseline|Dexamethasone Punctum Plug|"Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days~OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug"
172884|NCT01666210|P2|Participant Flow|Placebo Vehicle Punctum Plug|"Placebo punctum plug insertion~Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone"
172885|NCT01666210|P1|Participant Flow|Dexamethasone Punctum Plug|"Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days~OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug"
172886|NCT01666210|O2|Outcome|Placebo Vehicle Punctum Plug|"Placebo punctum plug insertion~Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone"
172887|NCT01666210|O1|Outcome|Dexamethasone Punctum Plug|"Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days~OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug"
172888|NCT01666210|O2|Outcome|Placebo Vehicle Punctum Plug|"Placebo punctum plug insertion~Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone"
172889|NCT01666210|O1|Outcome|Dexamethasone Punctum Plug|"Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days~OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug"
172890|NCT01666210|O2|Outcome|Placebo Vehicle Punctum Plug|"Placebo punctum plug insertion~Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone"
172891|NCT01666210|O1|Outcome|Dexamethasone Punctum Plug|"Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days~OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug"
172892|NCT01666210|E2|Reported Event|Placebo Vehicle Punctum Plug|"Placebo punctum plug insertion~Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone"
172893|NCT01666210|E1|Reported Event|Dexamethasone Punctum Plug|"Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days~OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug"
172894|NCT01666197|B3|Baseline|Total|Total of all reporting groups
172895|NCT01666197|B2|Baseline|Placebo|placebo: placebo
172896|NCT01666197|B1|Baseline|Diclofenac Potassium 25 mg Tablet|diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet
172897|NCT01666197|P2|Participant Flow|Placebo|placebo: placebo
172898|NCT01666197|P1|Participant Flow|Diclofenac Potassium 25 mg Tablet|diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet
172899|NCT01666197|O2|Outcome|Placebo|placebo: placebo
172900|NCT01666197|O1|Outcome|Diclofenac Potassium 25 mg Tablet|diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet
172901|NCT01666197|E2|Reported Event|Placebo|placebo: placebo
172902|NCT01666197|E1|Reported Event|Diclofenac Potassium 25 mg Tablet|diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet
172903|NCT01666119|B1|Baseline|BEMA Buprenorphine NX Films|"BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone)will be provided in 3.361 and 5.447 cm2 film sizes, respectively.~BEMA Buprenorphine NX films: BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone) will be provided in 3.361 and 5.447 cm2 film sizes, respectively."
172904|NCT01666119|P1|Participant Flow|BEMA Buprenorphine NX Films|"BEMA Buprenorphine/NX films (3.5/0.6, 5.25/0.9, 7/1.2, 10.5/1.8, and 14/2.4 mg).~BEMA Buprenorphine/NX films (3.5/0.6, 5.25/0.9, 7/1.2, 10.5/1.8, and 14/2.4 mg)."
172905|NCT01666119|O1|Outcome|BEMA Buprenorphine/NX Films|BEMA Buprenorphine/NX films (3.5/0.6mg, 5.25/0.9mg, 7.0/1.2mg, 10.5/1.7mg, 14.0/2.3mg)
172907|NCT01666119|E1|Reported Event|BEMA Buprenorphine NX Films|"BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone)will be provided in 3.361 and 5.447 cm2 film sizes, respectively.~BEMA Buprenorphine NX films: BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone) will be provided in 3.361 and 5.447 cm2 film sizes, respectively."
172908|NCT01666002|B3|Baseline|Total|Total of all reporting groups
172909|NCT01666002|B2|Baseline|Placebo|"st visit: For the control group, no treatment will be given.~nd visit: 2 weeks after initial visit, patient will be seen for second visit"
172910|NCT01666002|B1|Baseline|Treatment|"st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser"
172911|NCT01666002|P2|Participant Flow|Placebo|"st visit: For the control group, no treatment will be given.~nd visit: 2 weeks after initial visit, patient will be seen for second visit"
172912|NCT01666002|P1|Participant Flow|Treatment|"st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser~42 patients were assessed and 27 met eligibility criteria of a diagnosis of onychomycosis by clinical toenail morphology confirmed by positive culture."
172913|NCT01666002|O2|Outcome|Placebo|"st visit: For the control group, no treatment will be given.~nd visit: 2 weeks after initial visit, patient will be seen for second visit"
172914|NCT01666002|O1|Outcome|Treatment|"st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser"
172915|NCT01666002|O2|Outcome|Placebo|"st visit: For the control group, no treatment will be given.~nd visit: 2 weeks after initial visit, patient will be seen for second visit"
172916|NCT01666002|O1|Outcome|Treatment|"st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser~After 3 months, 4 of 12 patients (33%) in the laser group had negative fungal cultures. Of the 4 patients in the laser group with baseline cultures positive for a non-dermatophyte mold, 2 (50%) had negative fungal cultures. After 3 months of observation, 2 of 10 (20%) control subjects had negative cultures. Of the 3 patients in the control group with baseline cultures positive for a non-dermatophyte mold, 1 (33%) had a negative fungal culture. There was no significant difference in the percentage of patients with negative nail cultures between laser versus control groups (P = .49)."
172917|NCT01666002|E2|Reported Event|Placebo|"st visit: For the control group, no treatment will be given.~nd visit: 2 weeks after initial visit, patient will be seen for second visit"
172918|NCT01666002|E1|Reported Event|Treatment|"st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser~No patients reported complications or adverse events after 2 sessions."
172919|NCT01665950|B4|Baseline|Total|Total of all reporting groups
172920|NCT01665950|B3|Baseline|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the subsequent 4 weeks~Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
172921|NCT01665950|B2|Baseline|Placebo->Simvastatin|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the next 4 wks~Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: Subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks.~Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results ar"
172922|NCT01665950|B1|Baseline|Simvastatin-Simvastatin|"Subjects will receive simvastatin in phase 1 (4 weeks) and phase 2 (4 weeks)~Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: Subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
172923|NCT01665950|P3|Participant Flow|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the subsequent 4 weeks~Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
172934|NCT01665911|O1|Outcome|All Participants|"1.5 mg sodium fluoride in 100 ml milk 1.5 mg sodium fluoride in 200 ml milk 3 mg sodium fluoride in 100 ml milk 3 mg sodium fluoride in 200 ml milk non-fluoridated milk, 200 ml~Each of the subjects used all of the five inverventions listed above during this 5-period cross over study. Each subject had their own specific sequence of use."
183885|NCT01627002|E5|Reported Event|Part A PA401 10 mg|
172924|NCT01665950|P2|Participant Flow|Placebo->Simvastatin|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the next 4 wks~Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: Subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks.~Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results ar"
172925|NCT01665950|P1|Participant Flow|Simvastatin-Simvastatin|"Subjects will receive simvastatin in phase 1 (4 weeks) and phase 2 (4 weeks)~Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: Subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
172926|NCT01665950|O3|Outcome|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the subsequent 4 weeks~Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
172927|NCT01665950|O2|Outcome|Placebo->Simvastatin|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the next 4 wks~Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: Subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks.~Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results ar"
172928|NCT01665950|O1|Outcome|Simvastatin-Simvastatin|"Subjects will receive simvastatin in phase 1 (4 weeks) and phase 2 (4 weeks)~Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: Subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
172929|NCT01665950|E3|Reported Event|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the subsequent 4 weeks~Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
172930|NCT01665950|E2|Reported Event|Placebo->Simvastatin|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the next 4 wks~Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks.~Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results ar"
172931|NCT01665950|E1|Reported Event|Simvastatin-Simvastatin|"Subjects will receive simvastatin in phase 1 (4 weeks) and phase 2 (4 weeks)~Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
172932|NCT01665911|B1|Baseline|All Participants|"1.5 mg Sodium Fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.~1.5 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.~3 mg sodium fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.~3 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design~Non-fluoridated milk, 200 ml: Each subject will use this product during one of the five treatment periods in the crossover study design"
172933|NCT01665911|P1|Participant Flow|All Participants|"Each subject will use each of these products during each of the five treatment periods in the crossover study design. There were five interventions as follows:~. 1.5 mg Sodium Fluoride in 100 ml milk: .~1.5 mg Sodium Fluoride in 200 ml milk~3.0 mg Sodium Fluoride in 100 ml milk~3.0 mg Sodium Fluoride in 200 ml milk~0 mg fluoride in 200 ml milk"
173008|NCT01665170|P1|Participant Flow|Placebo|Placebo arm, 3 x 1 tablet per every day for 3 days
173009|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
173010|NCT01665170|O1|Outcome|Placebo|Placebo arm
172935|NCT01665911|O1|Outcome|All Participants|"Each subject will use each of these products during each of the five treatment periods in the crossover study design. There were five interventions as follows:~. 1.5 mg Sodium Fluoride in 100 ml milk: .~1.5 mg Sodium Fluoride in 200 ml milk~3.0 mg Sodium Fluoride in 100 ml milk~3.0 mg Sodium Fluoride in 200 ml milk~0 mg fluoride in 200 ml milk"
172936|NCT01665911|O1|Outcome|All Participants|"1.5 mg sodium fluoride in 100 ml milk 1.5 mg sodium fluoride in 200 ml milk 3 mg sodium fluoride in 100 ml milk 3 mg sodium fluoride in 200 ml milk non-fluoridated milk, 200 ml~Each of the subjects used all of the five inverventions listed above during this 5-period cross over study. Each subject had their own specific sequence of use."
172937|NCT01665911|E1|Reported Event|Arm/Group All Participants|"1.5 mg sodium fluoride in 100 ml milk 1.5 mg sodium fluoride in 200 ml milk 3 mg sodium fluoride in 100 ml milk 3 mg sodium fluoride in 200 ml milk non-fluoridated milk, 200 ml~1.5 mg Sodium Fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.~1.5 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.~3 mg sodium fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.~3 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design~Non-fluoridated milk, 200 ml: Each subject will use this product during one of the five treatment periods in the crossover study design."
172938|NCT01665807|B4|Baseline|Total|Total of all reporting groups
172939|NCT01665807|B3|Baseline|Self-administered Intradermal|"Self-administered intradermal influenza vaccine (Intanza 0.1 mL)~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
172940|NCT01665807|B2|Baseline|Repeat Self-administered Intradermal|"Self-administration (2) of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
172941|NCT01665807|B1|Baseline|Nurse-administered IM|"Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)~Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere"
172942|NCT01665807|P3|Participant Flow|Self-administered Intradermal|"Self-administered intradermal influenza vaccine (Intanza 0.1 mL)~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
172943|NCT01665807|P2|Participant Flow|Repeat Self-administration Intradermal|"Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
172944|NCT01665807|P1|Participant Flow|Nurse-administered IM|"Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)~Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere"
172945|NCT01665807|O3|Outcome|Self-administered Intradermal|"Self-administered intradermal influenza vaccine (Intanza 0.1 mL)~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
172946|NCT01665807|O2|Outcome|Repeat Self-administration Intradermal|"Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
172947|NCT01665807|O1|Outcome|Nurse-administered IM|"Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)~Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere"
172948|NCT01665807|O3|Outcome|Self-administered Intradermal|"Self-administered intradermal influenza vaccine (Intanza 0.1 mL)~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
172949|NCT01665807|O2|Outcome|Repeat Self-administration Intradermal|"Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
172950|NCT01665807|O1|Outcome|Nurse-administered IM|"Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)~Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere"
172951|NCT01665807|E3|Reported Event|Self-administered Intradermal|"Self-administered intradermal influenza vaccine (Intanza 0.1 mL)~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
172952|NCT01665807|E2|Reported Event|Repeat Self-administration Intradermal|"Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
172953|NCT01665807|E1|Reported Event|Nurse-administered IM|"Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)~Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere"
172954|NCT01665599|B1|Baseline|Testosterone Gel (FE 999303)|"Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.~Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion."
172955|NCT01665599|P1|Participant Flow|Testosterone Gel (FE 999303)|"Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.~Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion."
173011|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
173012|NCT01665170|O1|Outcome|Placebo|Placebo arm
173013|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
172956|NCT01665599|O1|Outcome|Testosterone Gel (FE 999303)|"Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.~Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion."
172957|NCT01665599|O1|Outcome|Testosterone Gel (FE 999303)|"Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.~Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion."
172958|NCT01665599|O1|Outcome|Testosterone Gel (FE 999303)|"Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.~Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion."
172959|NCT01665599|O1|Outcome|Testosterone Gel (FE 999303)|"Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.~Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion."
172960|NCT01665599|O1|Outcome|Testosterone Gel (FE 999303)|"Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.~Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion."
172961|NCT01665599|O1|Outcome|Testosterone Gel (FE 999303)|"Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.~Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion."
172962|NCT01665599|O1|Outcome|Testosterone Gel (FE 999303)|"Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.~Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion."
172963|NCT01665599|O1|Outcome|Testosterone Gel (FE 999303)|"Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.~Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion."
172964|NCT01665599|O1|Outcome|Testosterone Gel (FE 999303)|"Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.~Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion."
172965|NCT01665599|O1|Outcome|Testosterone Gel (FE 999303)|"Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.~Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion."
172966|NCT01665599|O1|Outcome|Testosterone Gel (FE 999303)|"Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.~Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion."
172967|NCT01665599|O1|Outcome|Testosterone Gel (FE 999303)|"Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.~Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion."
172968|NCT01665599|O1|Outcome|Testosterone Gel (FE 999303)|"Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.~Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion."
172969|NCT01665599|O1|Outcome|Testosterone Gel (FE 999303)|"Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.~Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion."
172970|NCT01665599|O1|Outcome|Testosterone Gel (FE 999303)|"Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.~Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion."
172971|NCT01665599|O1|Outcome|Testosterone Gel (FE 999303)|"Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.~Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion."
172972|NCT01665599|O1|Outcome|Testosterone Gel (FE 999303)|"Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.~Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion."
173014|NCT01665170|O1|Outcome|Placebo|Placebo arm
173015|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
172973|NCT01665599|E1|Reported Event|Testosterone Gel (FE 999303)|"Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.~Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion."
172974|NCT01665508|B1|Baseline|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.~Nebivolol: Patient to start nebivolol and have repeat testing in 3 months"
172975|NCT01665508|P1|Participant Flow|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.~Nebivolol: Patient to start nebivolol and have repeat testing in 3 months"
172976|NCT01665508|O2|Outcome|Baseline|results without nebivolol
172977|NCT01665508|O1|Outcome|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.~Nebivolol: Patient to start nebivolol and have repeat testing in 3 months~this data was incomplete and not useful for analysis"
172978|NCT01665508|O2|Outcome|Baseline|results prior to nebivolol start
172979|NCT01665508|O1|Outcome|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.~Nebivolol: Patient to start nebivolol and have repeat testing in 3 months~There was a significant improvement in angina stability (p=0.034) post treatment compared to baseline. The other parameter of the SAQ were not statistically different ( physical limitation, angina frequency, treatment satisfaction and quality of life)"
172980|NCT01665508|O2|Outcome|Baseline|results without nebivolol
172981|NCT01665508|O1|Outcome|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.~Nebivolol: Patient to start nebivolol and have repeat testing in 3 months~this data was incomplete and not useful for analysis"
172982|NCT01665508|O2|Outcome|Baseline|results off nebivolol
172983|NCT01665508|O1|Outcome|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.~Nebivolol: Patient to start nebivolol and have repeat testing in 3 months"
172984|NCT01665508|O1|Outcome|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.~Nebivolol: Patient to start nebivolol and have repeat testing in 3 months~this data was incomplete and not useful for analysis"
172985|NCT01665508|O2|Outcome|Baseline|results off nebivolol
172986|NCT01665508|O1|Outcome|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.~Nebivolol: Patient to start nebivolol and have repeat testing in 3 months"
172987|NCT01665508|O2|Outcome|Baseline|results prior to nebivolol start
172988|NCT01665508|O1|Outcome|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.~Nebivolol: Patient to start nebivolol and have repeat testing in 3 months~There was a significant improvement in angina stability (p=0.034) post treatment compared to baseline. The other parameter of the SAQ were not statistically different ( physical limitation, angina frequency, treatment satisfaction and quality of life)"
172989|NCT01665508|E1|Reported Event|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.~Nebivolol: Patient to start nebivolol and have repeat testing in 3 months"
172990|NCT01665430|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
172991|NCT01665430|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 4 weeks (q4w) up to 104 weeks.
172992|NCT01665430|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
172993|NCT01665430|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
172994|NCT01665430|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
172995|NCT01665430|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
172996|NCT01665430|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
172997|NCT01665430|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
172998|NCT01665430|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
172999|NCT01665430|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
173000|NCT01665430|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
173001|NCT01665430|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
173002|NCT01665430|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
173003|NCT01665430|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
173004|NCT01665170|B3|Baseline|Total|Total of all reporting groups
173005|NCT01665170|B2|Baseline|Verum|Verum arm - Pascoflair 425mg
173006|NCT01665170|B1|Baseline|Placebo|Placebo arm
173007|NCT01665170|P2|Participant Flow|Verum|Verum arm - Pascoflair 425mg, 3 x 1 tablet per every day for 3 days
173059|NCT01665157|P3|Participant Flow|Low-residue Diet Package and 1.5L PEG-ELS|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
173060|NCT01665157|P2|Participant Flow|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
173061|NCT01665157|P1|Participant Flow|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
173062|NCT01665157|O3|Outcome|Low-residue Diet Package Plus 1.5L PEG|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
173063|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
173064|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
173065|NCT01665157|O3|Outcome|Low-residue Diet Package and 1.5L PEG|Low-residue diet package(Enimaclin) with reduced volume 1.5L PEG-ELS
173066|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with 2L PEG-ELS
173067|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
173068|NCT01665157|O3|Outcome|Low-residue Diet Package and 1.5 L PEG-ELS|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
173069|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
173070|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
173071|NCT01665157|O3|Outcome|Low-residue Diet Package and 1.5L PEG|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
173072|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
173073|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
173074|NCT01665157|O3|Outcome|Low-residue Diet Package and 1.5L PEG|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
173075|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
173076|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
173077|NCT01665157|O3|Outcome|Low-residue Diet Package Plus 1.5L PEG-ELS|Low-residue diet package(Enimaclin) with reduced volume low volume 1.5L PEG-ELS
173078|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
173079|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
173080|NCT01665157|O3|Outcome|Low-residue Diet Package Plus 1.5L PEG|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
173081|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
173082|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
173083|NCT01665157|E3|Reported Event|Low-residue Diet Package Plus 1.5L PEG-ELS|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
173084|NCT01665157|E2|Reported Event|Self-controlled Diet|Self-controlled diet with normal amount 2L PEG-ELS
173085|NCT01665157|E1|Reported Event|Low-residue Diet Package|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
173086|NCT01665053|B3|Baseline|Total|Total of all reporting groups
173087|NCT01665053|B2|Baseline|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
173088|NCT01665053|B1|Baseline|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
173089|NCT01665053|P2|Participant Flow|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
173090|NCT01665053|P1|Participant Flow|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
173091|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
173092|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
173093|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
173094|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
173095|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
173096|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
173097|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
173098|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
173099|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
173100|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
173101|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
173102|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
173103|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
173104|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
173105|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
173106|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
173107|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
173108|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
173109|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
173110|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
173111|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
173112|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
173113|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
173114|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
173115|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
173116|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
173117|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
173141|NCT01664949|O2|Outcome|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
173118|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
173119|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
173120|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
173121|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
173122|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
173123|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
173124|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
173125|NCT01665053|E2|Reported Event|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
173126|NCT01665053|E1|Reported Event|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
173127|NCT01664975|B3|Baseline|Total|Total of all reporting groups
173128|NCT01664975|B2|Baseline|CHOP Regimen|"CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen~CHOP regimen: CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5."
173129|NCT01664975|B1|Baseline|GDPT Regimen|"GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen~GDPT regimen: GDPT regimen(Gemcitabine,Cisplatin,Prednisone ,Thalidomide) Cisplatin(DDP) 25 mg/m2,ivgtt（intravenously guttae）,d1-3;Prednisone 60mg/m2,p.o,d1-5;Gemcitabine(GEM) 800mg/m2,ivgtt,30min,d1,8;Thalidomide,p.o,200mg/d,Continued use to the end of chemotherapy .Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles."
173130|NCT01664975|P2|Participant Flow|CHOP Regimen|"CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen~CHOP regimen: CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5."
173131|NCT01664975|P1|Participant Flow|GDPT Regimen|"GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen~GDPT regimen: GDPT regimen(Gemcitabine,Cisplatin,Prednisone ,Thalidomide) Cisplatin(DDP) 25 mg/m2,ivgtt（intravenously guttae）,d1-3;Prednisone 60mg/m2,p.o,d1-5;Gemcitabine(GEM) 800mg/m2,ivgtt,30min,d1,8;Thalidomide,p.o,200mg/d,Continued use to the end of chemotherapy .Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles."
173132|NCT01664975|O2|Outcome|CHOP Regimen|"CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen~CHOP regimen: CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5."
173133|NCT01664975|O1|Outcome|GDPT Regimen|"GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen~GDPT regimen: GDPT regimen(Gemcitabine,Cisplatin,Prednisone ,Thalidomide) Cisplatin(DDP) 25 mg/m2,ivgtt（intravenously guttae）,d1-3;Prednisone 60mg/m2,p.o,d1-5;Gemcitabine(GEM) 800mg/m2,ivgtt,30min,d1,8;Thalidomide,p.o,200mg/d,Continued use to the end of chemotherapy .Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles."
173134|NCT01664975|E2|Reported Event|CHOP Regimen|"CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen~CHOP regimen: CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5."
173135|NCT01664975|E1|Reported Event|GDPT Regimen|"GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen~GDPT regimen: GDPT regimen(Gemcitabine,Cisplatin,Prednisone ,Thalidomide) Cisplatin(DDP) 25 mg/m2,ivgtt（intravenously guttae）,d1-3;Prednisone 60mg/m2,p.o,d1-5;Gemcitabine(GEM) 800mg/m2,ivgtt,30min,d1,8;Thalidomide,p.o,200mg/d,Continued use to the end of chemotherapy .Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles."
173136|NCT01664949|B3|Baseline|Total|Total of all reporting groups
173137|NCT01664949|B2|Baseline|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
173138|NCT01664949|B1|Baseline|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
173139|NCT01664949|P2|Participant Flow|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
173140|NCT01664949|P1|Participant Flow|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
173208|NCT01664624|O1|Outcome|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
173142|NCT01664949|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
173143|NCT01664949|O2|Outcome|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
173144|NCT01664949|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
173145|NCT01664949|O2|Outcome|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
173146|NCT01664949|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
173147|NCT01664949|O2|Outcome|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
173148|NCT01664949|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
173149|NCT01664949|O2|Outcome|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
173150|NCT01664949|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
173151|NCT01664949|E2|Reported Event|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
173152|NCT01664949|E1|Reported Event|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
173153|NCT01664923|B3|Baseline|Total|Total of all reporting groups
173154|NCT01664923|B2|Baseline|Bicalutamide|Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
173155|NCT01664923|B1|Baseline|Enzalutamide|Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
173156|NCT01664923|P2|Participant Flow|Bicalutamide|Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
173157|NCT01664923|P1|Participant Flow|Enzalutamide|Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
173158|NCT01664923|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
173159|NCT01664923|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
173160|NCT01664923|O2|Outcome|Bicalutamide|Participants randomized to receive bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
173161|NCT01664923|O1|Outcome|Enzalutamide|Participants randomized to receive enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
173162|NCT01664923|O2|Outcome|Bicalutamide|Participants randomized to receive bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
173163|NCT01664923|O1|Outcome|Enzalutamide|Participants randomized to receive enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
173164|NCT01664923|O2|Outcome|Bicalutamide|Participants randomized to receive bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
173165|NCT01664923|O1|Outcome|Enzalutamide|Participants randomized to receive enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
173166|NCT01664923|O2|Outcome|Bicalutamide|Participants randomized to receive bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
173167|NCT01664923|O1|Outcome|Enzalutamide|Participants randomized to receive enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
173168|NCT01664923|O2|Outcome|Bicalutamide|Participants randomized to receive bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
173169|NCT01664923|O1|Outcome|Enzalutamide|Participants randomized to receive enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
173170|NCT01664923|O2|Outcome|Bicalutamide|Participants randomized to receive bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
173171|NCT01664923|O1|Outcome|Enzalutamide|Participants randomized to receive enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
173172|NCT01664923|E2|Reported Event|Bicalutamide|Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
173173|NCT01664923|E1|Reported Event|Enzalutamide|Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
173174|NCT01664806|B3|Baseline|Total|Total of all reporting groups
173175|NCT01664806|B2|Baseline|Coag Mode 30 Watts Power|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.~Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy"
173176|NCT01664806|B1|Baseline|Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.~Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."
173209|NCT01664624|O4|Outcome|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
183886|NCT01627002|E4|Reported Event|Part A PA401 3.0 mg|
173177|NCT01664806|P2|Participant Flow|Coag Mode 30 Watts Power|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.~Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy"
173178|NCT01664806|P1|Participant Flow|Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.~Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."
173179|NCT01664806|O2|Outcome|Coag Mode 30 Watts Power|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.~Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy"
173180|NCT01664806|O1|Outcome|Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.~Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."
173181|NCT01664806|O2|Outcome|Coag Mode 30 Watts Power|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.~Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy"
173182|NCT01664806|O1|Outcome|Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.~Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."
173183|NCT01664806|E2|Reported Event|Coag Mode 30 Watts Power|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.~Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy"
173184|NCT01664806|E1|Reported Event|Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.~Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."
173185|NCT01664793|B3|Baseline|Total|Total of all reporting groups
173186|NCT01664793|B2|Baseline|Control Group|Children in 10 diverse pediatric and family practices. Baseline group are active patients of the practices with a visit between 3/1/2010 and 2/28/2011.
173187|NCT01664793|B1|Baseline|Intervention Group|Children in 10 diverse pediatric and family medicine practices. Baseline group are active patients of the practices with a visit between 3/1/2010 and 2/28/2011.
173188|NCT01664793|P2|Participant Flow|Control Group|Children who are active patients of 10 diverse pediatric and family medicine practices and who had at least one visit between 3/1/2011 and 2/29/2012 will serve as the control group; n=38,626. They will receive the 4 Pillars Toolkit and early season vaccine in Year 2.
173189|NCT01664793|P1|Participant Flow|Intervention Group|"Children who are active patients of 10 diverse pediatric and family medicine practices and who had at least one visit between 3/1/2011 and 2/29/2012 will serve as the Intervention group; n=49,039.~Intervention sites will use the 4 Pillars toolkit along with early season vaccine to promote increases in childhood influenza vaccination."
173190|NCT01664793|O2|Outcome|Control Group|This group did not rate effectiveness of the intervention.
173191|NCT01664793|O1|Outcome|Intervention Group|2 respondents in each of 10 diverse pediatric and family medicine practices.
173192|NCT01664793|O2|Outcome|Control Group|Children with a visit between 3/1/2011 and 2/29/2012 in 10 diverse pediatric and family practices.
173193|NCT01664793|O1|Outcome|Intervention Group|Children seen in 10 diverse pediatric and family medicine practices between 3/1/2011 and 2/29/2012.
173194|NCT01664793|E2|Reported Event|Control Group|Children in 10 diverse pediatric and family medicine practices seen between 8/1/2011 and 2/29/2012. We used the number of children who were vaccinated during intervention as the denominator for adverse events, because there is no other study-related risk for non-vaccinated children.
173195|NCT01664793|E1|Reported Event|Intervention Group|Children in 10 diverse pediatric and family medicine practices seen between 8/1/2011 and 2/29/2012. We used the number of children who were vaccinated during intervention as the denominator for adverse events, because there is no other study-related risk for non-vaccinated children.
173196|NCT01664624|B5|Baseline|Total|Total of all reporting groups
173197|NCT01664624|B4|Baseline|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
173198|NCT01664624|B3|Baseline|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
173199|NCT01664624|B2|Baseline|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
173200|NCT01664624|B1|Baseline|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
173201|NCT01664624|P4|Participant Flow|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
173202|NCT01664624|P3|Participant Flow|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
173203|NCT01664624|P2|Participant Flow|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
173204|NCT01664624|P1|Participant Flow|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
173205|NCT01664624|O4|Outcome|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
173206|NCT01664624|O3|Outcome|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
173207|NCT01664624|O2|Outcome|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
178541|NCT01645735|O1|Outcome|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
173210|NCT01664624|O3|Outcome|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
173211|NCT01664624|O2|Outcome|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
173212|NCT01664624|O1|Outcome|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
173213|NCT01664624|O4|Outcome|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
173214|NCT01664624|O3|Outcome|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
173215|NCT01664624|O2|Outcome|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
173216|NCT01664624|O1|Outcome|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
173217|NCT01664624|O4|Outcome|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
173218|NCT01664624|O3|Outcome|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
173219|NCT01664624|O2|Outcome|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
173220|NCT01664624|O1|Outcome|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
173221|NCT01664624|O4|Outcome|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
173222|NCT01664624|O3|Outcome|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
173223|NCT01664624|O2|Outcome|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
173224|NCT01664624|O1|Outcome|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
173225|NCT01664624|O4|Outcome|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
173226|NCT01664624|O3|Outcome|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
173227|NCT01664624|O2|Outcome|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
173228|NCT01664624|O1|Outcome|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
173229|NCT01664624|E4|Reported Event|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
173230|NCT01664624|E3|Reported Event|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
173231|NCT01664624|E2|Reported Event|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
173232|NCT01664624|E1|Reported Event|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
173233|NCT01664559|B3|Baseline|Total|Total of all reporting groups
173234|NCT01664559|B2|Baseline|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
173235|NCT01664559|B1|Baseline|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
173236|NCT01664559|P2|Participant Flow|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
173237|NCT01664559|P1|Participant Flow|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
173238|NCT01664559|O2|Outcome|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
173239|NCT01664559|O1|Outcome|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
173240|NCT01664559|O2|Outcome|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
173241|NCT01664559|O1|Outcome|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
173242|NCT01664559|O2|Outcome|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
173243|NCT01664559|O1|Outcome|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
173244|NCT01664559|O2|Outcome|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
173245|NCT01664559|O1|Outcome|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
173246|NCT01664559|O2|Outcome|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
173247|NCT01664559|O1|Outcome|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
173248|NCT01664559|E2|Reported Event|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
173249|NCT01664559|E1|Reported Event|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
173250|NCT01664533|B1|Baseline|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
173251|NCT01664533|P1|Participant Flow|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
173252|NCT01664533|O1|Outcome|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
173253|NCT01664533|O1|Outcome|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
173254|NCT01664533|O1|Outcome|Erlotinib|"Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.~Erlotinib: Erlotinib was supplied as tablets in the retail product Tarceva."
173255|NCT01664533|O1|Outcome|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
173256|NCT01664533|O1|Outcome|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
173257|NCT01664533|E1|Reported Event|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
173258|NCT01664494|B1|Baseline|Capecitabine|Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
173259|NCT01664494|P1|Participant Flow|Capecitabine|Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
173260|NCT01664494|O1|Outcome|Capecitabine|Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
173261|NCT01664494|O1|Outcome|Capecitabine|Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
173262|NCT01664494|E1|Reported Event|Capecitabine|Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
173263|NCT01664247|B3|Baseline|Total|Total of all reporting groups
173264|NCT01664247|B2|Baseline|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
173265|NCT01664247|B1|Baseline|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
173266|NCT01664247|P2|Participant Flow|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
173267|NCT01664247|P1|Participant Flow|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
173268|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
173312|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173269|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
173270|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
173271|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
173272|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
173273|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
173274|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
173275|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
173276|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
173277|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
173278|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
173279|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
173280|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
173313|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173314|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173315|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173316|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173281|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
173282|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
173283|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
173284|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
173285|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
173286|NCT01664247|E2|Reported Event|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
173287|NCT01664247|E1|Reported Event|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
173288|NCT01664117|B1|Baseline|bDMARD Monotherapy|Participants on bDMARD monotherapy for rheumatoid arthritis (RA) in routine clinical practice.
173289|NCT01664117|P1|Participant Flow|bDMARD Monotherapy|Participants on bDMARD monotherapy for rheumatoid arthritis (RA) in routine clinical practice.
173290|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173291|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173292|NCT01664117|O2|Outcome|Other Treatments|Participants on Other treatments for RA in routine clinical practice.
173293|NCT01664117|O1|Outcome|Tocilizumab|Participants on tocilizumab for RA in routine clinical practice.
173294|NCT01664117|O2|Outcome|Other Treatments|Participants on Other treatments for RA in routine clinical practice.
173295|NCT01664117|O1|Outcome|Tocilizumab|Participants on tocilizumab for RA in routine clinical practice.
173296|NCT01664117|O2|Outcome|Other Treatments|Participants on Other treatments for RA in routine clinical practice.
173297|NCT01664117|O1|Outcome|Tocilizumab|Participants on tocilizumab for RA in routine clinical practice.
173298|NCT01664117|O2|Outcome|Other Treatments|Participants on Other treatments for RA in routine clinical practice.
173299|NCT01664117|O1|Outcome|Tocilizumab|Participants on tocilizumab for RA in routine clinical practice.
173300|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173301|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173302|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173303|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173304|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173305|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173306|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173307|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173308|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173309|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173310|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173311|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
183887|NCT01627002|E3|Reported Event|Part A PA401 1.0 mg|
173320|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173321|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173322|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173323|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173324|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173325|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173326|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for rheumatoid arthritis (RA) in routine clinical practice.
173327|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173328|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173329|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173330|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173331|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173332|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173333|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173334|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173335|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173336|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173337|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173338|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173339|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173340|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173341|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173342|NCT01664117|E1|Reported Event|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
173343|NCT01664104|B1|Baseline|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173344|NCT01664104|P1|Participant Flow|Rheumatoid Arthritis (RA) Participants|Participants with moderate or severe RA who were under tocilizumab (TCZ) treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173345|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173346|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173347|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173348|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173349|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173350|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173351|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173352|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173353|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA were prescribed with tocilizumab, in accordance with routine clinic practice, and following the local label were observed for 6 months with maximum study duration of 18 months.
173354|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173355|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173356|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173357|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173358|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173359|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
183888|NCT01627002|E2|Reported Event|Part A PA401 0.3 mg|
173360|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173361|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173362|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173363|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173364|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173365|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173366|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173367|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173368|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173369|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173370|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173371|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173372|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173373|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173374|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173375|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173376|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173377|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173378|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173379|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173380|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173381|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173382|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173383|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173384|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173385|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173386|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173387|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were prescribed with tocilizumab, in accordance with routine clinic practice, and following the local label were observed for 6 months with maximum study duration of 18 months.
173388|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173389|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173390|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173391|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173392|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173393|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173394|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA were prescribed with tocilizumab, in accordance with routine clinic practice, and following the local label were observed for 6 months with maximum study duration of 18 months.
173395|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173396|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173397|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173398|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173399|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173400|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173401|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173402|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173403|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173404|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173405|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173406|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173407|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173408|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173409|NCT01664104|E1|Reported Event|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
173410|NCT01664052|B3|Baseline|Total|Total of all reporting groups
173411|NCT01664052|B2|Baseline|ESS305/ESS505|Unilateral placement of Essure 505 (BAY1454033) insert (PET-inclusive) and Contralateral placement of the current commercial Essure device Essure 305 (BAY1454032)
173412|NCT01664052|B1|Baseline|ESS505-A|Bilateral placement of Essure 505A (BAY1454033) insert (with minimal PET fiber).
173413|NCT01664052|P2|Participant Flow|ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
173414|NCT01664052|P1|Participant Flow|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
173415|NCT01664052|O3|Outcome|ESS505 (Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
173416|NCT01664052|O2|Outcome|ESS305 (Essure, BAY1454032)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
173417|NCT01664052|O1|Outcome|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
173418|NCT01664052|O3|Outcome|ESS505 (Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
173419|NCT01664052|O2|Outcome|ESS305 (Essure, BAY1454032)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
173420|NCT01664052|O1|Outcome|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
173421|NCT01664052|O3|Outcome|ESS505 (Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
173422|NCT01664052|O2|Outcome|ESS305 (Essure, BAY1454032)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
173423|NCT01664052|O1|Outcome|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
173424|NCT01664052|O3|Outcome|ESS505 (Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
173425|NCT01664052|O2|Outcome|ESS305 (Essure, BAY1454032)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
173426|NCT01664052|O1|Outcome|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
174514|NCT01660802|E1|Reported Event|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
173427|NCT01664052|E2|Reported Event|ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
173428|NCT01664052|E1|Reported Event|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
173429|NCT01664039|B3|Baseline|Total|Total of all reporting groups
173430|NCT01664039|B2|Baseline|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
173431|NCT01664039|B1|Baseline|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
173432|NCT01664039|P2|Participant Flow|LUMIGAN|One drop to the study eye(s) once a day in the evening, for 6 months
173433|NCT01664039|P1|Participant Flow|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
173434|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
173435|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
173436|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
173437|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
173438|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
173439|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
173440|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
173441|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
173442|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
173443|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
173444|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
173445|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
173446|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
173447|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
173448|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
173449|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
173450|NCT01664039|E2|Reported Event|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
173451|NCT01664039|E1|Reported Event|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
173452|NCT01663987|B3|Baseline|Total|Total of all reporting groups
173453|NCT01663987|B2|Baseline|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173454|NCT01663987|B1|Baseline|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173455|NCT01663987|P2|Participant Flow|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173456|NCT01663987|P1|Participant Flow|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173457|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173458|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173459|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173460|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173461|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173462|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173463|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173464|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173465|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173466|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173467|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173468|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173469|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173470|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
174463|NCT01660893|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
173471|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173472|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173473|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173474|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173475|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173476|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173477|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173478|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173479|NCT01663987|E2|Reported Event|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173480|NCT01663987|E1|Reported Event|Placebo|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173481|NCT01663922|B1|Baseline|All Participants|Descriptive analysis of combined groups
173482|NCT01663922|P2|Participant Flow|Group B (Boceprevir Then St John's Wort)|"Boceprevir for 5 days (10-14)~[wash out for 7 days (15-21)]~SJW for 14 days (22-35) plus boceprevir from day 31 to day 35 (5 days in total)~[wash out for 7 days (36-42)~SJW from day 43 to day 56"
173483|NCT01663922|P1|Participant Flow|Group A (St John's Wort Then Boceprevir)|"St John’s Wort, (SJW) for 14 days (1-14)~[wash out for 7 days (15-21)]~SJW for 14 days (22-35) plus boceprevir from day 31 to day 35 (5 days in total)~[wash out for 7 days (36-42)]~boceprevir from day 52 to day 56"
173484|NCT01663922|O1|Outcome|All Participants|Combined analysis of both group sequences
173485|NCT01663922|E2|Reported Event|Group B|Boceprevir first
173486|NCT01663922|E1|Reported Event|Group A|St John's Wort first
173487|NCT01663779|B3|Baseline|Total|Total of all reporting groups
173488|NCT01663779|B2|Baseline|Palpation Based Artery Catheterization|"Blind insertion of radial artery catheterization~Blind insertion of radial artery catheterization: Radial artery catheters will be placed by the palpation technique only."
173489|NCT01663779|B1|Baseline|Ultrasound Radial Artery Catheter|"Ultrasound guided radial artery catheterization.~Ultrasound guided radial artery catheterization.: Radial artery catheters will be placed with the assistance of bedside ultrasound."
173490|NCT01663779|P2|Participant Flow|Palpation Based Artery Catheterization|"Blind insertion of radial artery catheterization~Blind insertion of radial artery catheterization: Radial artery catheters will be placed by the palpation technique only."
173491|NCT01663779|P1|Participant Flow|Ultrasound Radial Artery Catheter|"Ultrasound guided radial artery catheterization.~Ultrasound guided radial artery catheterization.: Radial artery catheters will be placed with the assistance of bedside ultrasound."
173492|NCT01663779|O2|Outcome|Palpation|palpation artery
173493|NCT01663779|O1|Outcome|Ultrasound|ultrasound atery
173494|NCT01663779|E2|Reported Event|Palpation|palpation artery
173495|NCT01663779|E1|Reported Event|Ultrasound|ultrasound artery
173496|NCT01663727|B3|Baseline|Total|Total of all reporting groups
173497|NCT01663727|B2|Baseline|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173498|NCT01663727|B1|Baseline|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173499|NCT01663727|P2|Participant Flow|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 milligram per kilogram (mg/kg) on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173500|NCT01663727|P1|Participant Flow|Paclitaxel+Placebo|Participants received paclitaxel 90 milligrams per square meter (mg/m^2) intravenously (IV) on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173501|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173502|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173503|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173504|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173505|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173506|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173507|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173508|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173509|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173510|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173511|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173512|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173513|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173514|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173515|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173516|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173517|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173518|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173519|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173520|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173521|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173522|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173523|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173524|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173525|NCT01663727|E2|Reported Event|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173526|NCT01663727|E1|Reported Event|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
173527|NCT01663714|B1|Baseline|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
173528|NCT01663714|P1|Participant Flow|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemotherapy (chemo.): oral Cyclophosphamide (400 milligrams/meters squared [mg/m^2]/day) for 1-5 days; intravenous (IV) Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled tositumomab (TST) (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) Iodine 131. Par. received 4 drops by mouth (DBM) 3 times a day (TID) of potassium iodide (KI) and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the therapeutic dose (TD: a 1 hour IV infusion of 450 mg TST), followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
173555|NCT01663623|B2|Baseline|Belimumab 10 mg/kg|Participants were administered induction therapy (corticosteroids and either cyclophosphamide or rituximab) in the 6 months leading up to randomization. After randomization, participants were administered belimumab 10 mg/kg intravenously over 1 hour, at Day 0, 14, 28 and every 28 days thereafter until 12 months after the last subject was randomized. All participants received oral azathioprine at a target dose of 2 mg/kg/day. In Belgium-only open-label extension, all participants received belimumab 10 mg/kg every 28 days until Week 24, with a final evaluation at Week 28.
173781|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173529|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
173530|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
173531|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
173532|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
173533|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
173534|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
173535|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
173536|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
173589|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173782|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173537|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
173538|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
173539|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
173540|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
173541|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
173542|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
173543|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
173544|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
173590|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173922|NCT01662583|E2|Reported Event|Plain Text Message|"plain text message reminder~Text Message~Written reminder"
173545|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
173546|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
173547|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
173548|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
173549|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
173550|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
173551|NCT01663714|E3|Reported Event|Combined Regimen Period|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
173552|NCT01663714|E2|Reported Event|Period After Dosimetric and Therapeutic Dose|After receiving Cyclophosphamide, Vincristine, and Prednisone, par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled tositumomab (TST) (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) Iodine 131. Par. received 4 drops by mouth (DBM) 3 times a day (TID) of potassium iodide (KI) and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the therapeutic dose (TD: a 1 hour IV infusion of 450 mg TST), followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose.
173553|NCT01663714|E1|Reported Event|Period After CVP|Par. received 6 cycles of chemotherapy as follows: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; intravenous Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days
173554|NCT01663623|B3|Baseline|Total|Total of all reporting groups
173657|NCT01663103|O1|Outcome|Rilonacept|"12 weeks of treatment with rilonacept~Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
174515|NCT01660763|B3|Baseline|Total|Total of all reporting groups
173556|NCT01663623|B1|Baseline|Placebo|Participants were administered induction therapy (corticosteroids and either cyclophosphamide or rituximab) in the 6 months leading up to randomization. After randomization, participants were administered matching placebo intravenously over 1 hour, at Day 0, 14, 28 and every 28 days thereafter until 12 months after the last subject was randomized. All participants received oral azathioprine at a target dose of 2 milligram per kilogram per day (mg/kg/day). In Belgium-only open-label extension, all participants received belimumab 10mg/day every 28 days until Week 24, with a final evaluation at Week 28.
173557|NCT01663623|P2|Participant Flow|Belimumab 10 mg/kg|Participants were administered induction therapy (corticosteroids and either cyclophosphamide or rituximab) in the 6 months leading up to randomization. After randomization, participants were administered belimumab 10 mg/kg intravenously over 1 hour, at Day 0, 14, 28 and every 28 days thereafter until 12 months after the last subject was randomized. All participants received oral azathioprine at a target dose of 2 mg/kg/day. In Belgium-only open-label extension, all participants received belimumab 10 mg/kg every 28 days until Week 24, with a final evaluation at Week 28.
173558|NCT01663623|P1|Participant Flow|Placebo|Participants were administered induction therapy (corticosteroids and either cyclophosphamide or rituximab) in the 6 months leading up to randomization. After randomization, participants were administered matching placebo intravenously over 1 hour, at Day 0, 14, 28 and every 28 days thereafter until 12 months after the last subject was randomized. All participants received oral azathioprine at a target dose of 2 milligram per kilogram per day (mg/kg/day). In Belgium-only open-label extension, all participants received belimumab 10mg/day every 28 days until Week 24, with a final evaluation at Week 28.
173559|NCT01663623|O2|Outcome|Belimumab 10 mg/kg|Participants were administered induction therapy (corticosteroids and either cyclophosphamide or rituximab) in the 6 months leading up to randomization. After randomization, participants were administered belimumab 10 mg/kg intravenously over 1 hour, at Day 0, 14, 28 and every 28 days thereafter until 12 months after the last subject was randomized. All participants received oral azathioprine at a target dose of 2 mg/kg/day. In Belgium-only open-label extension, all participants received belimumab 10 mg/kg every 28 days until Week 24, with a final evaluation at Week 28.
173560|NCT01663623|O1|Outcome|Placebo|Participants were administered induction therapy (corticosteroids and either cyclophosphamide or rituximab) in the 6 months leading up to randomization. After randomization, participants were administered matching placebo intravenously over 1 hour, at Day 0, 14, 28 and every 28 days thereafter until 12 months after the last subject was randomized. All participants received oral azathioprine at a target dose of 2 milligram per kilogram per day (mg/kg/day). In Belgium-only open-label extension, all participants received belimumab 10mg/day every 28 days until Week 24, with a final evaluation at Week 28.
173561|NCT01663623|O2|Outcome|Belimumab 10 mg/kg|Participants were administered induction therapy (corticosteroids and either cyclophosphamide or rituximab) in the 6 months leading up to randomization. After randomization, participants were administered belimumab 10 mg/kg intravenously over 1 hour, at Day 0, 14, 28 and every 28 days thereafter until 12 months after the last subject was randomized. All participants received oral azathioprine at a target dose of 2 mg/kg/day. In Belgium-only open-label extension, all participants received belimumab 10 mg/kg every 28 days until Week 24, with a final evaluation at Week 28.
173562|NCT01663623|O1|Outcome|Placebo|Participants were administered induction therapy (corticosteroids and either cyclophosphamide or rituximab) in the 6 months leading up to randomization. After randomization, participants were administered matching placebo intravenously over 1 hour, at Day 0, 14, 28 and every 28 days thereafter until 12 months after the last subject was randomized. All participants received oral azathioprine at a target dose of 2 milligram per kilogram per day (mg/kg/day). In Belgium-only open-label extension, all participants received belimumab 10mg/day every 28 days until Week 24, with a final evaluation at Week 28.
173563|NCT01663623|E2|Reported Event|Belimumab 10 mg/kg|Participants were administered induction therapy (corticosteroids and either cyclophosphamide or rituximab) in the 6 months leading up to randomization. After randomization, participants were administered belimumab 10 mg/kg intravenously over 1 hour, at Day 0, 14, 28 and every 28 days thereafter until 12 months after the last subject was randomized. All participants received oral azathioprine at a target dose of 2 mg/kg/day. In Belgium-only open-label extension, all participants received belimumab 10 mg/kg every 28 days until Week 24, with a final evaluation at Week 28.
173564|NCT01663623|E1|Reported Event|Placebo|Participants were administered induction therapy (corticosteroids and either cyclophosphamide or rituximab) in the 6 months leading up to randomization. After randomization, participants were administered matching placebo intravenously over 1 hour, at Day 0, 14, 28 and every 28 days thereafter until 12 months after the last subject was randomized. All participants received oral azathioprine at a target dose of 2 milligram per kilogram per day (mg/kg/day). In Belgium-only open-label extension, all participants received belimumab 10mg/day every 28 days until Week 24, with a final evaluation at Week 28.
173565|NCT01663532|B3|Baseline|Total|Total of all reporting groups
173566|NCT01663532|B2|Baseline|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
173567|NCT01663532|B1|Baseline|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
173568|NCT01663532|P2|Participant Flow|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
173569|NCT01663532|P1|Participant Flow|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
173570|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
173571|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
173572|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
173573|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
173574|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
173575|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
173576|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
173577|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
173578|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
173579|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
173580|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
173581|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
173582|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
173583|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
173584|NCT01663532|E2|Reported Event|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
173585|NCT01663532|E1|Reported Event|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
173586|NCT01663506|B1|Baseline|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173587|NCT01663506|P1|Participant Flow|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab (RoActemra/Actemra) treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173588|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173736|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: single dose of Saxagliptin 5mg, Tablet, Oral.
173591|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173592|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173593|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173594|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173595|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173596|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173597|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173598|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173599|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173600|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173601|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173602|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173603|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173604|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173605|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173606|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173607|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173608|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173609|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173610|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173611|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173923|NCT01662583|E1|Reported Event|Educational Text Message|"Educational text message reminder~Text Message~Written reminder"
173612|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173613|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173614|NCT01663506|E1|Reported Event|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
173615|NCT01663363|B1|Baseline|Wavefront-guided LASIK|LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
173616|NCT01663363|P1|Participant Flow|Wavefront-guided LASIK|LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
173617|NCT01663363|O1|Outcome|Wavefront-guided LASIK|LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.
173618|NCT01663363|O1|Outcome|Wavefront-guided LASIK|LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.
173619|NCT01663363|E1|Reported Event|Wavefront-guided LASIK|LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.
173620|NCT01663285|B1|Baseline|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
173621|NCT01663285|P1|Participant Flow|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
173622|NCT01663285|O1|Outcome|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
173623|NCT01663285|O1|Outcome|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
173624|NCT01663285|O1|Outcome|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
173625|NCT01663285|E1|Reported Event|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
173626|NCT01663233|B3|Baseline|Total|Total of all reporting groups
173627|NCT01663233|B2|Baseline|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
173628|NCT01663233|B1|Baseline|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
173629|NCT01663233|P2|Participant Flow|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
173630|NCT01663233|P1|Participant Flow|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
173631|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
173632|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
173633|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
173924|NCT01662531|B3|Baseline|Total|Total of all reporting groups
173634|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
173635|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
173636|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
173637|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
173638|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
173639|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
173640|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
173641|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
173642|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
173643|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
173644|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
173645|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
173646|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
173647|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
173648|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
173649|NCT01663233|E2|Reported Event|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
173650|NCT01663233|E1|Reported Event|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
173651|NCT01663103|B3|Baseline|Total|Total of all reporting groups
173652|NCT01663103|B2|Baseline|Placebo|"Twelve weeks of treatment with placebo~Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
173653|NCT01663103|B1|Baseline|Rilonacept|"12 weeks of treatment with rilonacept~Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
173654|NCT01663103|P2|Participant Flow|Placebo|"Twelve weeks of treatment with placebo~Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
173655|NCT01663103|P1|Participant Flow|Rilonacept|"12 weeks of treatment with rilonacept~Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
173656|NCT01663103|O2|Outcome|Placebo|"Twelve weeks of treatment with placebo~Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
183889|NCT01627002|E1|Reported Event|Part A PA401 0.1 mg|
173658|NCT01663103|O2|Outcome|Placebo|"Twelve weeks of treatment with placebo~Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
173659|NCT01663103|O1|Outcome|Rilonacept|"12 weeks of treatment with rilonacept~Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
173660|NCT01663103|O4|Outcome|Placebo: End of Study|Change in flow-mediated dilation following an acute infusion of ascorbic acid (as compared to saline) in the placebo group at baseline
173661|NCT01663103|O3|Outcome|Placebo: Baseline|Change in flow-mediated dilation following an acute infusion of ascorbic acid (as compared to saline) in the placebo group at baseline
173662|NCT01663103|O2|Outcome|Rilonacept: End of Study|Change in flow-mediated dilation following an acute infusion of ascorbic acid (as compared to saline) in the rilonacept group at 12 weeks.
173663|NCT01663103|O1|Outcome|Rilonacept: Baseline|Change in flow-mediated dilation following an acute infusion of ascorbic acid (as compared to saline) in the rilonacept group at baseline.
173664|NCT01663103|O2|Outcome|Placebo|"Twelve weeks of treatment with placebo~Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
173665|NCT01663103|O1|Outcome|Rilonacept|"12 weeks of treatment with rilonacept~Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
173666|NCT01663103|O2|Outcome|Placebo|"Twelve weeks of treatment with placebo~Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
173667|NCT01663103|O1|Outcome|Rilonacept|"12 weeks of treatment with rilonacept~Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
173668|NCT01663103|E2|Reported Event|Placebo|"Twelve weeks of treatment with placebo~Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
173669|NCT01663103|E1|Reported Event|Rilonacept|"12 weeks of treatment with rilonacept~Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
173670|NCT01663012|B1|Baseline|Drug: Etirinotecan Pegol|"145 mg/m2 dose~Etirinotecan pegol"
173671|NCT01663012|P1|Participant Flow|Drug: Etirinotecan Pegol|"145 mg/m2 dose~Etirinotecan pegol"
173672|NCT01663012|O1|Outcome|Drug: Etirinotecan Pegol|"145 mg/m2 dose~Etirinotecan pegol"
173673|NCT01663012|O1|Outcome|Drug: Etirinotecan Pegol|"145 mg/m2 dose~Etirinotecan pegol"
173674|NCT01663012|O1|Outcome|Drug: Etirinotecan Pegol|"145 mg/m2 dose~Etirinotecan pegol"
173675|NCT01663012|E1|Reported Event|Drug: Etirinotecan Pegol|"145 mg/m2 dose~Etirinotecan pegol"
173676|NCT01662999|B7|Baseline|Total|Total of all reporting groups
173677|NCT01662999|B6|Baseline|C-B-A: (Saxagliptin+Dapagliflozin)-Dapagliflozin-Saxagliptin|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral.
173678|NCT01662999|B5|Baseline|C-A-B: (Saxagliptin+Dapagliflozin)-Saxagliptin-Dapagliflozin|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets,Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral.
173679|NCT01662999|B4|Baseline|B-C-A: Dapagliflozin-(Saxagliptin+Dapagliflozin)-Saxagliptin|Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral.
173680|NCT01662999|B3|Baseline|B-A-C: Dapagliflozin-Saxagliptin-(Saxagliptin+Dapagliflozin)|Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral
173681|NCT01662999|B2|Baseline|A-C-B: Saxagliptin-(Saxagliptin+Dapagliflozin)-Dapagliflozin|Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral.
173682|NCT01662999|B1|Baseline|A-B-C: Saxagliptin-Dapagliflozin-(Saxagliptin+Dapagliflozin)|Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral.
173683|NCT01662999|P6|Participant Flow|C-B-A: (Saxagliptin+Dapagliflozin)-Dapagliflozin-Saxagliptin|"Single dose of:~Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet"
173684|NCT01662999|P5|Participant Flow|C-A-B: (Saxagliptin+Dapagliflozin)-Saxagliptin-Dapagliflozin|"Single dose of:~Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral"
173685|NCT01662999|P4|Participant Flow|B-C-A: Dapagliflozin-(Saxagliptin+Dapagliflozin)-Saxagliptin|"Single dose of:~Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral"
173686|NCT01662999|P3|Participant Flow|B-A-C: Dapagliflozin-Saxagliptin-(Saxagliptin+Dapagliflozin)|"Single dose of:~Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral"
173687|NCT01662999|P2|Participant Flow|A-C-B: Saxagliptin-(Saxagliptin+Dapagliflozin)-Dapagliflozin|"Single dose of:~Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral"
173688|NCT01662999|P1|Participant Flow|A-B-C: Saxagliptin-Dapagliflozin-(Saxagliptin+Dapagliflozin)|"Single dose of:~Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral"
173689|NCT01662999|O6|Outcome|C-B-A: (Saxagliptin+Dapagliflozin)-Dapagliflozin-Saxagliptin|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral.
173690|NCT01662999|O5|Outcome|C-A-B: (Saxagliptin+Dapagliflozin)-Saxagliptin-Dapagliflozin|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets,Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral.
173691|NCT01662999|O4|Outcome|B-C-A: Dapagliflozin-(Saxagliptin+Dapagliflozin)-Saxagliptin|Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral.
173692|NCT01662999|O3|Outcome|B-A-C: Dapagliflozin-Saxagliptin-(Saxagliptin+Dapagliflozin)|Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral
173693|NCT01662999|O2|Outcome|A-C-B: Saxagliptin-(Saxagliptin+Dapagliflozin)-Dapagliflozin|Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral.
173694|NCT01662999|O1|Outcome|A-B-C: Saxagliptin-Dapagliflozin-(Saxagliptin+Dapagliflozin)|Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral.
173695|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet 5mg saxagliptin.
173696|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Single dose oral tablet of 10 mg dapagliflozin
173697|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
173698|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
173699|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Single dose oral tablet of 10 mg dapagliflozin
173700|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
173701|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet 5mg saxagliptin.
173702|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Single dose oral tablet of 10 mg dapagliflozin.
173703|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
173704|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet 5mg saxagliptin.
173705|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Single dose oral tablet of 10 mg dapagliflozin.
173706|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
173707|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet 5mg saxagliptin.
173708|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Single dose oral tablet of 10 mg dapagliflozin.
173709|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
173710|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet 5mg saxagliptin.
173711|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Single dose oral tablet of 10 mg dapagliflozin.
173712|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
173713|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet 5mg saxagliptin.
173714|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|A single oral tablet dose of 10 mg Dapagliflozin.
173715|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
173716|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Treatment C: Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin..
173717|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Treatment B: A single oral tablet dose of 10 mg Dapagliflozin.
173718|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Treatment A: Single dose oral tablet of 5 mg saxagliptin..
173719|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
173720|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: Single dose oral tablet of 5 mg saxagliptin.
173721|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
173722|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: Single dose oral tablet of 5 mg saxagliptin.
173723|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
173724|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: Single saxagliptin 5mg, Tablet, Oral.
173725|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
173726|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: Single dose oral tablet of 5 mg saxagliptin.
173727|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
173728|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: Single dose oral tablet of 5 mg saxagliptin.
173729|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
173730|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg dapagliflozin.
173731|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
173732|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg dapagliflozin.
173733|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
173734|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: single dose of Saxagliptin 5mg, Tablet, Oral.
173735|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
173737|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
173738|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg dapagliflozin.
173739|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
173740|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin.
173741|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
173742|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: Single dose Saxagliptin 5mg, Tablet, Oral.
173743|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
173744|NCT01662999|O1|Outcome|10mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin
173745|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
173746|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin.
173747|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
173748|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin.
173749|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
173750|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin.
173751|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
173752|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin
173753|NCT01662999|E3|Reported Event|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, Once daily, 1 day in each of 3 periods.
173754|NCT01662999|E2|Reported Event|Treatment B: Dapagliflozin 10mg|Dapagliflozin 10mg, Tablet, Oral, Once daily, 1 day in each of 3 periods.
173755|NCT01662999|E1|Reported Event|Treatment A: Saxagliptin 5mg|Saxagliptin 5mg, Tablet, Oral, Once daily, 1 day in each of 3 periods.
173756|NCT01662986|B3|Baseline|Total|Total of all reporting groups
173757|NCT01662986|B2|Baseline|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173758|NCT01662986|B1|Baseline|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173759|NCT01662986|P2|Participant Flow|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173760|NCT01662986|P1|Participant Flow|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173761|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173762|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173763|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173764|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173765|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173766|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173767|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173768|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173769|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173770|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173771|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173772|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173773|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173774|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173775|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173776|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173777|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173778|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173779|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173780|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173783|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173784|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173785|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
173786|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
173787|NCT01662986|E2|Reported Event|Tiotropium Bromide (18 μg)|Patient to receive one tiotropium bromide inhalation powder capsule once daily in the morning via HandiHaler
173788|NCT01662986|E1|Reported Event|Placebo|Patient to receive one placebo inhalation powder capsule once daily in the morning via HandiHaler
173789|NCT01662908|B3|Baseline|Total|Total of all reporting groups
173790|NCT01662908|B2|Baseline|Warfarin|Participants treated with warfarin
173791|NCT01662908|B1|Baseline|Edoxaban|Participants treated with edoxaban
173792|NCT01662908|P2|Participant Flow|Warfarin|Participants treated with warfarin
173793|NCT01662908|P1|Participant Flow|Edoxaban|Participants treated with edoxaban
173794|NCT01662908|O2|Outcome|Warfarin|Participants treated with warfarin
173795|NCT01662908|O1|Outcome|Edoxaban|Participants treated with edoxaban
173796|NCT01662908|O2|Outcome|Warfarin|Participants treated with warfarin
173797|NCT01662908|O1|Outcome|Edoxaban|Participants treated with edoxaban
173798|NCT01662908|O2|Outcome|Warfarin|Participants treated with warfarin
173799|NCT01662908|O1|Outcome|Edoxaban|Participants treated with edoxaban
173800|NCT01662908|O2|Outcome|Warfarin|Participants treated with warfarin
173801|NCT01662908|O1|Outcome|Edoxaban|Participants treated with edoxaban
173802|NCT01662908|O2|Outcome|Warfarin|Participants treated with warfarin
173803|NCT01662908|O1|Outcome|Edoxaban|Participants treated with edoxaban
173804|NCT01662908|E2|Reported Event|Warfarin|Participants treated with warfarin
173805|NCT01662908|E1|Reported Event|Edoxaban|Participants treated with edoxaban
173806|NCT01662882|B4|Baseline|Total|Total of all reporting groups
173807|NCT01662882|B3|Baseline|MCI Subjects|"MCI (mild cognitive impairment)~florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose"
173808|NCT01662882|B2|Baseline|Healthy Controls|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
173809|NCT01662882|B1|Baseline|AD Subjects|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
173810|NCT01662882|P3|Participant Flow|MCI Subjects|"MCI (mild cognitive impairment)~florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose"
173811|NCT01662882|P2|Participant Flow|Healthy Controls|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
173812|NCT01662882|P1|Participant Flow|AD Subjects|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
173813|NCT01662882|O3|Outcome|Healthy Controls|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
173814|NCT01662882|O2|Outcome|MCI Subjects|"MCI (mild cognitive impairment)~florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose"
173815|NCT01662882|O1|Outcome|AD Subjects|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
173816|NCT01662882|O3|Outcome|Healthy Controls|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
173817|NCT01662882|O2|Outcome|MCI Subjects|"MCI (mild cognitive impairment)~florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose"
173818|NCT01662882|O1|Outcome|AD Subjects|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
173819|NCT01662882|E3|Reported Event|Healthy Controls|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
173820|NCT01662882|E2|Reported Event|MCI Subjects|"MCI (mild cognitive impairment)~florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose"
173821|NCT01662882|E1|Reported Event|AD Subjects|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
173822|NCT01662856|B3|Baseline|Total|Total of all reporting groups
173823|NCT01662856|B2|Baseline|Manual Compression|Direct manual compression of target bleeding site with gauze/laparotomy pads.
173824|NCT01662856|B1|Baseline|Fibrin Sealant Grifols|Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
173825|NCT01662856|P2|Participant Flow|Manual Compression|Direct manual compression of target bleeding site with gauze/laparotomy pads.
173826|NCT01662856|P1|Participant Flow|Fibrin Sealant Grifols|Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
173827|NCT01662856|O2|Outcome|Manual Compression|Direct manual compression of target bleeding site with gauze/laparotomy pads.
173828|NCT01662856|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
173829|NCT01662856|O2|Outcome|Manual Compression|Direct manual compression of target bleeding site with gauze/laparotomy pads.
173830|NCT01662856|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
173831|NCT01662856|O2|Outcome|Manual Compression|Direct manual compression of target bleeding site with gauze/laparotomy pads.
173832|NCT01662856|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
173833|NCT01662856|O2|Outcome|Manual Compression|Direct manual compression of target bleeding site with gauze/laparotomy pads.
173834|NCT01662856|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
173835|NCT01662856|E2|Reported Event|Manual Compression|Direct manual compression of target bleeding site with gauze/laparotomy pads.
173836|NCT01662856|E1|Reported Event|Fibrin Sealant Grifols|Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
173837|NCT01662791|B3|Baseline|Total|Total of all reporting groups
173838|NCT01662791|B2|Baseline|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
173839|NCT01662791|B1|Baseline|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
173840|NCT01662791|P2|Participant Flow|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day; they did not take part in the second part of the study.
173841|NCT01662791|P1|Participant Flow|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO twice a day (BID) for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
173842|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
173843|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
173844|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
173845|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
173846|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
173847|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
173848|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
173849|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
173850|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
173851|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
173852|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
173853|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
173854|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
174384|NCT01661140|P1|Participant Flow|Initial Phase|At Week 0 participants started open-label tocilizumab and open-label methotrexate (MTX) for 24 weeks, which was the initial phase of the study.
173855|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
173856|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
173857|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
173858|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
173859|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
173860|NCT01662791|E2|Reported Event|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
173861|NCT01662791|E1|Reported Event|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
173862|NCT01662765|B3|Baseline|Total|Total of all reporting groups
173863|NCT01662765|B2|Baseline|Surgery|"Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.~Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination."
173864|NCT01662765|B1|Baseline|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.~postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry."
173865|NCT01662765|P2|Participant Flow|Surgery|"Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.~Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination."
173866|NCT01662765|P1|Participant Flow|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.~postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry.~conservative: this treatment will include conservative procedures under local anesthesia for patient comfort."
173867|NCT01662765|O2|Outcome|Surgery|Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.
173868|NCT01662765|O1|Outcome|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus."
173869|NCT01662765|O2|Outcome|Surgery|Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.
173870|NCT01662765|O1|Outcome|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus."
173871|NCT01662765|O2|Outcome|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.~postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry.~conservative: this treatment will include conservative procedures under local anesthesia for patient comfort."
173872|NCT01662765|O1|Outcome|Surgery|"Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.~Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination.~Surgery: modified umbilectomy"
173873|NCT01662765|O2|Outcome|Surgery|"Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.~Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination."
173874|NCT01662765|O1|Outcome|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.~postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry.~conservative: this treatment will include conservative procedures under local anesthesia for patient comfort."
173875|NCT01662765|E2|Reported Event|Surgery|"Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.~Approximation of the subcutaneous tissue with a single purse-string absorbable suture."
173876|NCT01662765|E1|Reported Event|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus."
173877|NCT01662648|B3|Baseline|Total|Total of all reporting groups
173878|NCT01662648|B2|Baseline|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
173879|NCT01662648|B1|Baseline|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
173880|NCT01662648|P2|Participant Flow|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
173881|NCT01662648|P1|Participant Flow|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
173882|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
173883|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
173884|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
173885|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
173886|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
173887|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
173888|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
173889|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
173890|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
173891|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
173984|NCT01662440|O4|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, i.e. placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
173892|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
173893|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
173894|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
173895|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
173896|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
173897|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
173898|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
173899|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
173900|NCT01662648|E2|Reported Event|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
173901|NCT01662648|E1|Reported Event|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
173902|NCT01662635|B1|Baseline|Demographics and Clinical Features of Overall Population|The baseline characteristics of our population were on basis of the presence or absence of ALK gene.
173903|NCT01662635|P1|Participant Flow|Determination of ALK by FISH, IHC and RT-qPCR|"The only inclusion criterion was the availability of tissue for biomarker studies.~We use a commercially available break-apart probe kit specific to the ALK locus (Vysis LSI ALK Dual Color (split-apart); using the commercially mouse monoclonal ALK antibody for IHC and . Variants 1, 2, 3a, 4 and 5. The qPCR reactions were performed using the TaqMan Universal PCR MasterMix (Applied Biosystems/TaqMan, Life Technologies)"
173904|NCT01662635|O3|Outcome|RT-qPCR Test|The qPCR reactions were performed using the TaqMan Universal PCR MasterMix (Applied Biosystems/TaqMan, Life Technologies) and the following Taqman assays: Hs03654556_ft (E13;A20), Hs03654557_ft (E20;A20), Hs03654558_ft (E6;A20), Hs03654560_ft (E17;A20), and Hs03654559_ft (E18;A20). Hs02758991_ft (GAPDH) assays, whose expression levels are known to be nearly stable among lung tumors
173905|NCT01662635|O2|Outcome|IHC Test|using the commercially mouse monoclonal ALK antibody (dilution 1:25, clone 5A4; Abcam, Cambridge, UK), with OptiView DAB detection Kit (Ventana, Tucson, Arizona, USA). ALK IHC was performed according to the protocols provided by the antibody.
173906|NCT01662635|O1|Outcome|FISH Test|We use a commercially available break-apart probe kit specific to the ALK locus (Vysis LSI ALK Dual Color (split-apart); Abbott Molecular, Abbott Park, IL, USA). Slide washing, and counterstaining by DAPI were done following the manufacturer´s protocol (Abbott Molecular, Abbott Park, IL, USA).
173907|NCT01662635|E1|Reported Event|Adverse Events Not Collected|"Serious and Other were not collected/assessed in this observational study."
173908|NCT01662583|B4|Baseline|Total|Total of all reporting groups
173909|NCT01662583|B3|Baseline|Written Reminder Only|"written reminder at time of vaccination~Written reminder"
173910|NCT01662583|B2|Baseline|Plain Text Message|"plain text message reminder~Text Message~Written reminder"
173911|NCT01662583|B1|Baseline|Educational Text Message|"Educational text message reminder~Text Message~Written reminder"
173912|NCT01662583|P3|Participant Flow|Written Reminder Only|"written reminder at time of vaccination~Written reminder"
173913|NCT01662583|P2|Participant Flow|Plain Text Message|"plain text message reminder~Text Message~Written reminder"
173914|NCT01662583|P1|Participant Flow|Educational Text Message|"Educational text message reminder~Text Message~Written reminder"
173915|NCT01662583|O3|Outcome|Written Reminder Only|"written reminder at time of vaccination~Written reminder"
173916|NCT01662583|O2|Outcome|Plain Text Message|"plain text message reminder~Text Message~Written reminder"
173917|NCT01662583|O1|Outcome|Educational Text Message|"Educational text message reminder~Text Message~Written reminder"
173918|NCT01662583|O3|Outcome|Written Reminder Only|"written reminder at time of vaccination~Written reminder"
173919|NCT01662583|O2|Outcome|Plain Text Message|"plain text message reminder~Text Message~Written reminder"
173920|NCT01662583|O1|Outcome|Educational Text Message|"Educational text message reminder~Text Message~Written reminder"
173921|NCT01662583|E3|Reported Event|Written Reminder Only|"written reminder at time of vaccination~Written reminder"
173925|NCT01662531|B2|Baseline|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
173926|NCT01662531|B1|Baseline|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
173927|NCT01662531|P1|Participant Flow|rIX-FP|"Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) will be administered by IV infusion as routine weekly prophylaxis and episodic treatment for bleeding episodes.~rIX-FP: Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP)"
173928|NCT01662531|O3|Outcome|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
173929|NCT01662531|O2|Outcome|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
173930|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
173931|NCT01662531|O3|Outcome|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
173932|NCT01662531|O2|Outcome|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
173933|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
173934|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
173935|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
173936|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
173937|NCT01662531|O3|Outcome|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
173938|NCT01662531|O2|Outcome|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
173939|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
173940|NCT01662531|O3|Outcome|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
173941|NCT01662531|O2|Outcome|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
173942|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
173943|NCT01662531|O3|Outcome|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
173944|NCT01662531|O2|Outcome|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
173945|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
173946|NCT01662531|O3|Outcome|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
173947|NCT01662531|O2|Outcome|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
173948|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
173949|NCT01662531|E1|Reported Event|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
173950|NCT01662492|B4|Baseline|Total|Total of all reporting groups
173951|NCT01662492|B3|Baseline|Placebo (Normal Saline)|Placebo (Normal Saline) intramuscular injections into specified muscles.
173952|NCT01662492|B2|Baseline|Botulinum Toxin Type A 74 U|Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
173953|NCT01662492|B1|Baseline|Botulinum Toxin Type A 155 U|Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
173954|NCT01662492|P3|Participant Flow|Placebo (Normal Saline)|Placebo (Normal Saline) intramuscular injections into specified muscles.
173955|NCT01662492|P2|Participant Flow|Botulinum Toxin Type A 74 U|Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
173956|NCT01662492|P1|Participant Flow|Botulinum Toxin Type A 155 U|Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
173957|NCT01662492|O3|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) intramuscular injections into specified muscles.
173958|NCT01662492|O2|Outcome|Botulinum Toxin Type A 74 U|Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
173959|NCT01662492|O1|Outcome|Botulinum Toxin Type A 155 U|Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
173960|NCT01662492|O3|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) intramuscular injections into specified muscles.
173961|NCT01662492|O2|Outcome|Botulinum Toxin Type A 74 U|Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
173962|NCT01662492|O1|Outcome|Botulinum Toxin Type A 155 U|Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
173963|NCT01662492|O3|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) intramuscular injections into specified muscles.
173964|NCT01662492|O2|Outcome|Botulinum Toxin Type A 74 U|Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
173965|NCT01662492|O1|Outcome|Botulinum Toxin Type A 155 U|Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
173966|NCT01662492|O3|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) intramuscular injections into specified muscles.
173967|NCT01662492|O2|Outcome|Botulinum Toxin Type A 74 U|Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
173968|NCT01662492|O1|Outcome|Botulinum Toxin Type A 155 U|Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
173969|NCT01662492|O3|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) intramuscular injections into specified muscles.
173970|NCT01662492|O2|Outcome|Botulinum Toxin Type A 74 U|Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
173971|NCT01662492|O1|Outcome|Botulinum Toxin Type A 155 U|Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
173972|NCT01662492|E3|Reported Event|Placebo (Normal Saline)|Placebo (Normal Saline) intramuscular injections into specified muscles.
173973|NCT01662492|E2|Reported Event|Botulinum Toxin Type A 74 U|Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.
173974|NCT01662492|E1|Reported Event|Botulinum Toxin Type A 155 U|Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.
173975|NCT01662440|B5|Baseline|Total|Total of all reporting groups
173976|NCT01662440|B4|Baseline|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
173977|NCT01662440|B3|Baseline|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.
173978|NCT01662440|B2|Baseline|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
173979|NCT01662440|B1|Baseline|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
173980|NCT01662440|P4|Participant Flow|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
173981|NCT01662440|P3|Participant Flow|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.
173982|NCT01662440|P2|Participant Flow|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
173983|NCT01662440|P1|Participant Flow|R/JE – Conv|Subjects received Rabies and Japanese Encephalitis (JE) vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
174038|NCT01662336|O1|Outcome|Month 6|
173985|NCT01662440|O3|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.
173986|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, i.e. Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
173987|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
173988|NCT01662440|O4|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
173989|NCT01662440|O3|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
173990|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
173991|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
173992|NCT01662440|O4|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
173993|NCT01662440|O3|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
173994|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
173995|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
173996|NCT01662440|O3|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
173997|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
173998|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
173999|NCT01662440|O3|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
174000|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
174001|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
174002|NCT01662440|O3|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
174003|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
174004|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
174005|NCT01662440|O3|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
174006|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
174007|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
174008|NCT01662440|O3|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
174009|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
174010|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
174011|NCT01662440|O3|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
174114|NCT01662115|O2|Outcome|Regular Chewing Gum|"100 subjects who will be part of a control group~Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first"
174012|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
174013|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
174014|NCT01662440|O2|Outcome|JE – Conv|Group Description Subjects received Rabies and JE vaccines, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
174015|NCT01662440|O1|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
174016|NCT01662440|O2|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
174017|NCT01662440|O1|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
174018|NCT01662440|O2|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, i.e. placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
174019|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
174020|NCT01662440|O2|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
174021|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
174022|NCT01662440|O2|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
174023|NCT01662440|O1|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
174024|NCT01662440|O2|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
174025|NCT01662440|O1|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
174026|NCT01662440|E4|Reported Event|JE – Conv|Subjects received JE vaccine, conventional schedule, i.e. placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
174027|NCT01662440|E3|Reported Event|R – Conv|Subjects received Rabies vaccine, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.
174028|NCT01662440|E2|Reported Event|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, i.e. Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
174029|NCT01662440|E1|Reported Event|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
174030|NCT01662362|B1|Baseline|Testing Donor Specimens With ESA Chagas|"Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.~Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw."
174031|NCT01662362|P1|Participant Flow|Testing Donor Specimens With ESA Chagas|"Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.~Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw."
174032|NCT01662362|O1|Outcome|Testing Donor Specimens With ESA Chagas|Test blood donor specimens that are ABBOTT PRISM Chagas Nonreactive with ESA Chagas. These specimens will be unidentified specimens from routine donor testing and not individually identifiable. Specimens that are positive or indeterminate with ESA Chagas will be further tested with RIPA.
174033|NCT01662362|O1|Outcome|Testing Donor Specimens With ESA Chagas|"Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.~Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw."
174034|NCT01662362|E1|Reported Event|Testing Donor Specimens With ESA Chagas|"Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.~Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw."
174035|NCT01662336|B1|Baseline|Lopinavir/Ritonavir + KASA|Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
174036|NCT01662336|P1|Participant Flow|Lopinavir/Ritonavir + KASA|Patients were treated according to the standard of care provided by their respective study sites. Treatments with lopinavir / ritonavir (LPV/r; Kaletra®) and participation in the Kaletra Adherence Support Assistance (KASA) program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
174037|NCT01662336|O2|Outcome|Month 12|
174039|NCT01662336|O1|Outcome|Lopinavir/Ritonavir + KASA|Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
174040|NCT01662336|O1|Outcome|Lopinavir/Ritonavir + KASA|Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
174041|NCT01662336|O3|Outcome|Month 12|
174042|NCT01662336|O2|Outcome|Month 6|
174043|NCT01662336|O1|Outcome|Baseline|
174044|NCT01662336|O1|Outcome|Lopinavir/Ritonavir + KASA|Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
174045|NCT01662336|O1|Outcome|Lopinavir/Ritonavir + KASA|Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
174046|NCT01662336|O1|Outcome|Lopinavir/Ritonavir + KASA|Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
174047|NCT01662336|O1|Outcome|Lopinavir/Ritonavir + KASA|Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
174048|NCT01662336|O1|Outcome|Lopinavir/Ritonavir + KASA|Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
174049|NCT01662336|O1|Outcome|Lopinavir/Ritonavir + KASA|Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
174050|NCT01662336|O1|Outcome|Lopinavir/Ritonavir + KASA|Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
174051|NCT01662336|O1|Outcome|Lopinavir/Ritonavir + KASA|Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
174052|NCT01662336|O1|Outcome|Lopinavir/Ritonavir + KASA|Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
174053|NCT01662336|O1|Outcome|Lopinavir/Ritonavir + KASA|Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
174054|NCT01662336|O1|Outcome|Lopinavir/Ritonavir + KASA|Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
174055|NCT01662336|O1|Outcome|Lopinavir/Ritonavir + KASA|Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
174056|NCT01662336|O1|Outcome|Lopinavir/Ritonavir + KASA|Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
174057|NCT01662336|O1|Outcome|Lopinavir/Ritonavir + KASA|Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
174058|NCT01662336|O1|Outcome|Lopinavir/Ritonavir + KASA|Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
174059|NCT01662336|O1|Outcome|Lopinavir/Ritonavir + KASA|Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
174060|NCT01662336|E1|Reported Event|Lopinavir/Ritonavir + KASA|Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
174061|NCT01662310|B1|Baseline|Entire Study Population|All the participants who were enrolled.
178696|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
174062|NCT01662310|P5|Participant Flow|Placebo DB/Paliperidone OL Extension Phase|Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
174063|NCT01662310|P4|Participant Flow|Paliperidone DB/Paliperidone Open-label (OL) Extension Phase|Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
174064|NCT01662310|P3|Participant Flow|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo once daily during DB phase of the study.
174065|NCT01662310|P2|Participant Flow|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received paliperidone at a starting dose of 3 mg up to 12 mg, fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
174066|NCT01662310|P1|Participant Flow|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 milligram per day (mg/day) after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
174067|NCT01662310|O2|Outcome|Placebo DB/Paliperidone OL Extension Phase|Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
174068|NCT01662310|O1|Outcome|Paliperidone DB/Paliperidone Open-label (OL) Extension Phase|Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
174069|NCT01662310|O2|Outcome|Placebo DB/Paliperidone OL Extension Phase|Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
174070|NCT01662310|O1|Outcome|Paliperidone DB/Paliperidone Open-label (OL) Extension Phase|Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
174071|NCT01662310|O2|Outcome|Placebo DB/Paliperidone OL Extension Phase|Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
174072|NCT01662310|O1|Outcome|Paliperidone DB/Paliperidone Open-label (OL) Extension Phase|Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
174073|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
174074|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
174075|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
174076|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
174077|NCT01662310|O1|Outcome|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
174078|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
174079|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
174080|NCT01662310|O1|Outcome|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
174081|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
174082|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
174115|NCT01662115|O1|Outcome|Nicotine Gum|"100 subjects who will actually get the intervention medication~Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first"
174083|NCT01662310|O1|Outcome|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
174084|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
174085|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
174086|NCT01662310|O1|Outcome|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
174087|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
174088|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
174089|NCT01662310|O1|Outcome|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
174090|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
174091|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
174092|NCT01662310|E5|Reported Event|Placebo DB/Paliperidone OL Extension Phase|Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
174093|NCT01662310|E4|Reported Event|Paliperidone DB/Paliperidone Open-label (OL) Extension Phase|Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
174094|NCT01662310|E3|Reported Event|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo once daily during DB phase of the study.
174095|NCT01662310|E2|Reported Event|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received paliperidone at a starting dose of 3 mg up to 12 mg, fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
174096|NCT01662310|E1|Reported Event|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
174097|NCT01662115|B4|Baseline|Total|Total of all reporting groups
174098|NCT01662115|B3|Baseline|No Gum|100 subjects who will not get neither the intervention nor the placebo gum.
174099|NCT01662115|B2|Baseline|Regular Chewing Gum|"100 subjects who will be part of a control group~Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first"
174100|NCT01662115|B1|Baseline|Nicotine Gum|"100 subjects who will actually get the intervention medication~Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first"
174101|NCT01662115|P3|Participant Flow|No Gum|100 subjects who will not get neither the intervention nor the placebo gum.
174102|NCT01662115|P2|Participant Flow|Regular Chewing Gum|"100 subjects who will be part of a control group~Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first"
174103|NCT01662115|P1|Participant Flow|Nicotine Gum|"100 subjects who will actually get the intervention medication~Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first"
174104|NCT01662115|O3|Outcome|No Gum|100 subjects who will not get neither the intervention nor the placebo gum.
174105|NCT01662115|O2|Outcome|Regular Chewing Gum|"100 subjects who will be part of a control group~Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first"
174106|NCT01662115|O1|Outcome|Nicotine Gum|"100 subjects who will actually get the intervention medication~Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first"
174107|NCT01662115|O3|Outcome|No Gum|100 subjects who will not get neither the intervention nor the placebo gum.
174108|NCT01662115|O2|Outcome|Regular Chewing Gum|"100 subjects who will be part of a control group~Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first"
174109|NCT01662115|O1|Outcome|Nicotine Gum|"100 subjects who will actually get the intervention medication~Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first"
174110|NCT01662115|O3|Outcome|No Gum|100 subjects who will not get neither the intervention nor the placebo gum.
174111|NCT01662115|O2|Outcome|Regular Chewing Gum|"100 subjects who will be part of a control group~Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first"
174112|NCT01662115|O1|Outcome|Nicotine Gum|"100 subjects who will actually get the intervention medication~Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first"
174113|NCT01662115|O3|Outcome|No Gum|100 subjects who will not get neither the intervention nor the placebo gum.
174116|NCT01662115|E3|Reported Event|No Gum|100 subjects who will not get neither the intervention nor the placebo gum.
174117|NCT01662115|E2|Reported Event|Regular Chewing Gum|"100 subjects who will be part of a control group~Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first"
174118|NCT01662115|E1|Reported Event|Nicotine Gum|"100 subjects who will actually get the intervention medication~Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first"
174119|NCT01662102|B3|Baseline|Total|Total of all reporting groups
174120|NCT01662102|B2|Baseline|Rituximab|"Patients will receive 375 mg/m^2 of rituximab, administered by I.V. infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle.~Rituximab: Group B: Response maintenance with 375 mg/m^2 of rituximab every 8 weeks for 24 months (12 infusions)"
174121|NCT01662102|B1|Baseline|Zevalin and Rituximab|"90Y-Ibritumomab tiuxetan will be administered 8 to 12 weeks after the last chemotherapy infusion. Each patient randomized to this treatment group will receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Patients with a pre-treatment platelet count between 100 and 149 x109/L will receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan.The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion.~Zevalin: Group A: Response consolidation with a single dose of 90Y-ibritumomab tiuxetan (Zevalin®) 0.4 mCi/Kg - Maximum dose: 32 mCi given with 2 doses of rituximab followed by observation for 24 months;"
174122|NCT01662102|P2|Participant Flow|Rituximab|"Patients will receive 375 mg/m^2 of rituximab, administered by I.V. infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle.~Rituximab: Group B: Response maintenance with 375 mg/m2 of rituximab every 8 weeks for 24 months (12 infusions)"
174123|NCT01662102|P1|Participant Flow|Zevalin and Rituximab|"90Y-Ibritumomab tiuxetan will be administered 8 to 12 weeks after the last chemotherapy infusion. Each patient randomized to this treatment group will receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Patients with a pre-treatment platelet count between 100 and 149 x109/L will receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan.The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion.~Zevalin: Group A: Response consolidation with a single dose of 90Y-ibritumomab tiuxetan (Zevalin®) 0.4 mCi/Kg - Maximum dose: 32 mCi given with 2 doses of rituximab followed by observation for 24 months;"
174124|NCT01662102|O2|Outcome|Rituximab|"Patients will receive 375 mg/m2 of rituximab, administered by I.V. infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle.~Rituximab: Group B: Response maintenance with 375 mg/m2 of rituximab every 8 weeks for 24 months (12 infusions)"
174125|NCT01662102|O1|Outcome|Zevalin and Rituximab|"90Y-Ibritumomab tiuxetan will be administered 8 to 12 weeks after the last chemotherapy infusion. Each patient randomized to this treatment group will receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Patients with a pre-treatment platelet count between 100 and 149 x109/L will receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan.The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m2); Day 7,8, or 9 rituximab (250 mg/m2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion.~Zevalin: Group A: Response consolidation with a single dose of 90Y-ibritumomab tiuxetan (Zevalin®) 0.4 mCi/Kg - Maximum dose: 32 mCi given with 2 doses of rituximab followed by observation for 24 months;"
174126|NCT01662102|E2|Reported Event|Rituximab|"Patients will receive 375 mg/m2 of rituximab, administered by I.V. infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle.~Rituximab: Group B: Response maintenance with 375 mg/m2 of rituximab every 8 weeks for 24 months (12 infusions)"
174127|NCT01662102|E1|Reported Event|Zevalin and Rituximab|"90Y-Ibritumomab tiuxetan will be administered 8 to 12 weeks after the last chemotherapy infusion. Each patient randomized to this treatment group will receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Patients with a pre-treatment platelet count between 100 and 149 x109/L will receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan.The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m2); Day 7,8, or 9 rituximab (250 mg/m2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion.~Zevalin: Group A: Response consolidation with a single dose of 90Y-ibritumomab tiuxetan (Zevalin®) 0.4 mCi/Kg - Maximum dose: 32 mCi given with 2 doses of rituximab followed by observation for 24 months;"
174128|NCT01662063|B3|Baseline|Total|Total of all reporting groups
174129|NCT01662063|B2|Baseline|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174130|NCT01662063|B1|Baseline|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174131|NCT01662063|P3|Participant Flow|Not Treated|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) were enrolled in this LTE study for an additional 96 weeks. Participants who met Screening criteria but did not receive treatment were excluded from analysis and reported in a separate arm.
174132|NCT01662063|P2|Participant Flow|SC TCZ Every Week (QW)|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174133|NCT01662063|P1|Participant Flow|Subcutaneous (SC) Tocilizumab (TCZ) Every 2 Weeks (Q2W)|Participants with moderate to severe rheumatoid arthritis (RA) who completed treatment with SC or intravenous (IV) TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this long-term extension (LTE) study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 milligrams (mg) Q2W.
174512|NCT01660802|O1|Outcome|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
174134|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174135|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174136|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174137|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174138|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174139|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174140|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174141|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174142|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174143|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174144|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174145|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174146|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174147|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174148|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174149|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174150|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174151|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174152|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174153|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174154|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174155|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174156|NCT01662063|O1|Outcome|SC TCZ/All Participants|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW or SC TCZ 162 mg Q2W.
174157|NCT01662063|O1|Outcome|SC TCZ/All Participants|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW or SC TCZ 162 mg Q2W.
174158|NCT01662063|O1|Outcome|SC TCZ/All Participants|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW or SC TCZ 162 mg Q2W.
174159|NCT01662063|O1|Outcome|SC TCZ/All Participants|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW or SC TCZ 162 mg Q2W.
174160|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174161|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174162|NCT01662063|O1|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174163|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174164|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174165|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174166|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174167|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174168|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174169|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174170|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174425|NCT01661114|P1|Participant Flow|Gemcitabine, 5-FU and Cisplatin|4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
174171|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174172|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174173|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174174|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174175|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174176|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174177|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174178|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174179|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174180|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174181|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174182|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174183|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174184|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174185|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174186|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174187|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174188|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174189|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174190|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174191|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174192|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174193|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174194|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174195|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174196|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174197|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174198|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174199|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174200|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174201|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174202|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174203|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174204|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174205|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174206|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174207|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174208|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174513|NCT01660802|E2|Reported Event|Sham|Sham administered in the study eye on Day 1.
174209|NCT01662063|E2|Reported Event|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
174210|NCT01662063|E1|Reported Event|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
174211|NCT01662024|B1|Baseline|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures"
174212|NCT01662024|P1|Participant Flow|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. Dietitian visits were performed at 1, 3, 6, 9, and 12 months to assess for the development of eating disorders. Clinical visits were performed at 1, 3, 6, and 12 months to obtain size and weight data. Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period."
174213|NCT01662024|O1|Outcome|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures."
174214|NCT01662024|O1|Outcome|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures."
174215|NCT01662024|O1|Outcome|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures."
174216|NCT01662024|O1|Outcome|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures"
174217|NCT01662024|O1|Outcome|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures."
174218|NCT01662024|O1|Outcome|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. D"
174219|NCT01662024|O1|Outcome|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. Dietitian visits were performed at 1, 3, 6, 9, and 12 months to assess for the development of eating disorders. Clinical visits were performed at 1, 3, 6, and 12 months to obtain size and weight data. Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period."
174220|NCT01662024|E1|Reported Event|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures."
174221|NCT01661972|B3|Baseline|Total|Total of all reporting groups
174222|NCT01661972|B2|Baseline|Phase 2|Capecitabine at the recommended dose based on Phase 1 (850mg/m2) given on days 1-14. Aflibercept 6 mg/kg given intravenously every 3 weeks. Both agents are administered on a 21-day cycle.
174223|NCT01661972|B1|Baseline|Phase 1|Capecitabine is given days 1-14 of a 21 day cycle. Cohort 1 will receive 850mg/m2 Capecitabine and Cohort 2 will receive 1000mg/m2. Aflibercept 6 mg/kg is given intravenously every 3 weeks.
174224|NCT01661972|P2|Participant Flow|Phase 2|Capecitabine at the recommended dose based on Phase 1 (850mg/m2) given on days 1-14. Aflibercept 6 mg/kg given intravenously every 3 weeks. Both agents are administered on a 21-day cycle.
174225|NCT01661972|P1|Participant Flow|Phase 1|Capecitabine is given days 1-14 of a 21 day cycle. Cohort 1 will receive 850mg/m2 Capecitabine and Cohort 2 will receive 1000mg/m2. Aflibercept 6 mg/kg is given intravenously every 3 weeks.
174226|NCT01661972|O1|Outcome|Phase 2|Capecitabine at the recommended dose based on Phase 1, given days 1-14 and off days 15-21. Aflibercept 6 mg/kg given intravenously every 3 weeks. Both agents are administered on a 21-day cycle.
174227|NCT01661972|O1|Outcome|Phase 2|Capecitabine at the recommended dose based on Phase 1, given days 1-14 and off days 15-21. Aflibercept 6 mg/kg given intravenously every 3 weeks. Both agents are administered on a 21-day cycle.
174228|NCT01661972|O1|Outcome|Phase 2|Capecitabine at the recommended dose based on Phase 1, given days 1-14 and off days 15-21. Aflibercept 6 mg/kg given intravenously every 3 weeks. Both agents are administered on a 21-day cycle.
174229|NCT01661972|O2|Outcome|Phase 1 Cohort 2|Capecitabine 1000 mg/m2 given days 1-14 and off days 15-21. Aflibercept 6 mg/kg given intravenously every 3 weeks. Both agents are administered on a 21-day cycle.
174230|NCT01661972|O1|Outcome|Phase 1 Cohort 1|Capecitabine 850mg/m2 given days 1-14 and off days 15-21. Aflibercept 6 mg/kg given intravenously every 3 weeks. Both agents are administered on a 21-day cycle.
174231|NCT01661972|O1|Outcome|Phase 1|Aflibercept 6 mg/kg given intravenously every 3 weeks. Capecitabine was given at 850mg/m2 for the first cohort and at 1000mg/m2 for the second cohort.
183890|NCT01626820|B3|Baseline|Total|Total of all reporting groups
174232|NCT01661972|E2|Reported Event|Phase 2|Capecitabine at the recommended dose based on Phase 1 (850mg/m2) given on days 1-14. Aflibercept 6 mg/kg given intravenously every 3 weeks. Both agents are administered on a 21-day cycle.
174233|NCT01661972|E1|Reported Event|Phase 1|Capecitabine is given days 1-14 of a 21 day cycle. Cohort 1 will receive 850mg/m2 Capecitabine and Cohort 2 will receive 1000mg/m2. Aflibercept 6 mg/kg is given intravenously every 3 weeks.
174234|NCT01661933|B1|Baseline|Gluten Micro-challenge|Single arm, vertical. All twelve healthy adults enrolled subjects were successfully inoculated with hookworm and there was no serious adverse response. Individual hemoglobin levels were all normal and the group mean had significantly increased unexpectedly at completion of the study. Histology was not graded until after low-dose challenge but retrospectively confirmed enrollment Marsh scores of M0-8, M1-1, M2-2 and M3a-1. All participants were complying with a gluten-free diet, were symptomatically well and had a normal anti-tTG.
174235|NCT01661933|P1|Participant Flow|Necator Americanus, Gluten Challenge|Single arm, vertical. Necator americanus: Subjects were inoculated with 20 3rd stage Na larvae (10 + 10 over 4-8 weeks). After hookworm colonization, a micro-dose gluten challenge of 10 mg daily for 6 weeks, followed by 50 mg daily for 6 weeks was completed. After this, a detailed assessment including histology was performed to establish it safe for the participant to proceed to a low-dose gluten challenge of 25 mg daily and 1 G (15-20 G of pasta) twice weekly for 12 weeks. After low-dose challenge, a further evaluation was undertaken before inviting participants to undertake a gluten challenge of 3 G daily over for 2 weeks (preceded by a micro-dose 2 week lead-in).
174236|NCT01661933|O1|Outcome|Necator Americanus, Gluten Challenge|Single arm, vertical. Necator americanus: Subjects were inoculated with 20 3rd stage Na larvae (10 + 10 over 4-8 weeks). After hookworm colonization, a micro-dose gluten challenge of 10 mg daily for 6 weeks, followed by 50 mg daily for 6 weeks was completed. After this, a detailed assessment including histology was performed to establish it safe for the participant to proceed to a low-dose gluten challenge of 25 mg daily and 1 G (15-20 G of pasta) twice weekly for 12 weeks. After low-dose challenge, a further evaluation was undertaken before inviting participants to undertake a gluten challenge of 3 G daily over for 2 weeks (preceded by a micro-dose 2 week lead-in).
174237|NCT01661933|O1|Outcome|Necator Americanus, Pre-gluten Challenge|Single arm, vertical. Ten of 12 participants enrolled based on symptomatic tolerance of gluten and satisfactory histology during and after micro-challenge. 2 were withdrawn pre-GC-1g, one who was symptomatically intolerant of gluten and one who had M3a after micro-challenge. Pre-GC1g scores.
174238|NCT01661933|O1|Outcome|Necator Americanus, Gluten Challenge|Single arm, vertical. Necator americanus: Subjects were inoculated with 20 3rd stage Na larvae (10 + 10 over 4-8 weeks). After hookworm colonization, a micro-dose gluten challenge of 10 mg daily for 6 weeks, followed by 50 mg daily for 6 weeks was completed. After this, a detailed assessment including histology was performed to establish it safe for the participant to proceed to a low-dose gluten challenge of 25 mg daily and 1 G (15-20 G of pasta) twice weekly for 12 weeks. After low-dose challenge, a further evaluation was undertaken before inviting participants to undertake a gluten challenge of 3 G daily over for 2 weeks (preceded by a micro-dose 2 week lead-in).
174239|NCT01661933|O1|Outcome|Necator Americanus, Gluten Challenge|Single arm, vertical. Necator americanus: Subjects were inoculated with 20 3rd stage Na larvae (10 + 10 over 4-8 weeks). After hookworm colonization, a micro-dose gluten challenge of 10 mg daily for 6 weeks, followed by 50 mg daily for 6 weeks was completed. After this, assessments including histology were performed to establish it safe for the participant to proceed to a low-dose gluten challenge of 25 mg daily and 1 G (15-20 G of pasta) twice weekly for 12 weeks. After low-dose challenge, a further evaluation was undertaken before inviting participants to undertake a gluten challenge of 3 G daily over for 2 weeks (preceded by a micro-dose 2 week lead-in).
174240|NCT01661933|E1|Reported Event|Gluten Micro-challenge|Single arm, longitudinal study of responses to escalating gluten doses in people with celiac disease after infection with Necator americanus, a human hookworm.
174241|NCT01661881|B1|Baseline|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:~2 g/m2 for age >60 years old, creatinine 114.9–176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;~1.5 g/m2 for age >60 years old AND creatinine 114.9–176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;~1 g/m2 for age > 60 years old AND creatinine 114.9–176.8 lmol/l AND pre-existing neurotoxicity."
174242|NCT01661881|P1|Participant Flow|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:~2 g/m2 for age >60 years old, creatinine 114.9–176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;~1.5 g/m2 for age >60 years old AND creatinine 114.9–176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;~1 g/m2 for age > 60 years old AND creatinine 114.9–176.8 lmol/l AND pre-existing neurotoxicity."
174243|NCT01661881|O1|Outcome|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:~2 g/m2 for age >60 years old, creatinine 114.9–176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;~1.5 g/m2 for age >60 years old AND creatinine 114.9–176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;~1 g/m2 for age > 60 years old AND creatinine 114.9–176.8 lmol/l AND pre-existing neurotoxicity. Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study."
174274|NCT01661764|O1|Outcome|rs174535 (GG), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174275|NCT01661764|O6|Outcome|rs174535 (TT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174276|NCT01661764|O5|Outcome|rs174535 (TT), Fish Oil Supplement|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174244|NCT01661881|O1|Outcome|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:~2 g/m2 for age >60 years old, creatinine 114.9–176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;~1.5 g/m2 for age >60 years old AND creatinine 114.9–176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;~1 g/m2 for age > 60 years old AND creatinine 114.9–176.8 lmol/l AND pre-existing neurotoxicity. Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study."
174245|NCT01661881|O1|Outcome|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:~2 g/m2 for age >60 years old, creatinine 114.9–176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;~1.5 g/m2 for age >60 years old AND creatinine 114.9–176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;~1 g/m2 for age > 60 years old AND creatinine 114.9–176.8 lmol/l AND pre-existing neurotoxicity. Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study."
174246|NCT01661881|E1|Reported Event|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:~2 g/m2 for age >60 years old, creatinine 114.9–176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;~1.5 g/m2 for age >60 years old AND creatinine 114.9–176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;~1 g/m2 for age > 60 years old AND creatinine 114.9–176.8 lmol/l AND pre-existing neurotoxicity.~Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study."
174247|NCT01661790|B3|Baseline|Total|Total of all reporting groups
174248|NCT01661790|B2|Baseline|Cisplatin|"Cisplatin 30mg by intrapleural given every two weeks~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
174249|NCT01661790|B1|Baseline|Bevacizumab & Cisplatin|"Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks~Bevacizumab: Bevacizumab300mg&Cisplatin 30mg by intrapleural administration of each 2 week~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
174250|NCT01661790|P2|Participant Flow|Cisplatin|"Cisplatin 30mg by intrapleural given every two weeks~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
174251|NCT01661790|P1|Participant Flow|Bevacizumab & Cisplatin|"Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks~Bevacizumab: Bevacizumab300mg&Cisplatin 30mg by intrapleural administration of each 2 week~Cisplatin: Cisplatin 30mg,intrapleural administration,each 2 week"
174252|NCT01661790|O2|Outcome|Cisplatin|"Cisplatin 30mg by intrapleural given every two weeks~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
174253|NCT01661790|O1|Outcome|Bevacizumab & Cisplatin|"Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks~Bevacizumab: Bevacizumab300mg&Cisplatin 30mg by intrapleural administration of each 2 week~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
174254|NCT01661790|E2|Reported Event|Cisplatin|"Cisplatin 30mg by intrapleural given every two weeks~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
174255|NCT01661790|E1|Reported Event|Bevacizumab & Cisplatin|"Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks~Bevacizumab: Bevacizumab300mg&Cisplatin 30mg by intrapleural administration of each 2 week~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
174256|NCT01661764|B7|Baseline|Total|Total of all reporting groups
174257|NCT01661764|B6|Baseline|rs174535 (TT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174258|NCT01661764|B5|Baseline|rs174535 (TT), Fish Oil Supplement|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174259|NCT01661764|B4|Baseline|rs174535 (GT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174260|NCT01661764|B3|Baseline|rs174535 (GT), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174261|NCT01661764|B2|Baseline|rs174535 (GG), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174262|NCT01661764|B1|Baseline|rs174535 (GG), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174263|NCT01661764|P6|Participant Flow|rs174535 (TT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174264|NCT01661764|P5|Participant Flow|rs174535 (TT), Fish Oil Supplement|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174265|NCT01661764|P4|Participant Flow|rs174535 (GT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174266|NCT01661764|P3|Participant Flow|rs174535 (GT), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174267|NCT01661764|P2|Participant Flow|rs174535 (GG), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174268|NCT01661764|P1|Participant Flow|rs174535 (GG), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174269|NCT01661764|O6|Outcome|rs174535 (TT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174270|NCT01661764|O5|Outcome|rs174535 (TT), Fish Oil Supplement|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174271|NCT01661764|O4|Outcome|rs174535 (GT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174272|NCT01661764|O3|Outcome|rs174535 (GT), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174273|NCT01661764|O2|Outcome|rs174535 (GG), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174278|NCT01661764|O3|Outcome|rs174535 (GT), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174279|NCT01661764|O2|Outcome|rs174535 (GG), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174280|NCT01661764|O1|Outcome|rs174535 (GG), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174281|NCT01661764|O6|Outcome|rs174535 (TT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174282|NCT01661764|O5|Outcome|rs174535 (TT), Fish Oil Supplement|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174283|NCT01661764|O4|Outcome|rs174535 (GT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174284|NCT01661764|O3|Outcome|rs174535 (GT), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174285|NCT01661764|O2|Outcome|rs174535 (GG), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174286|NCT01661764|O1|Outcome|rs174535 (GG), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174287|NCT01661764|O6|Outcome|rs174535 (TT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174288|NCT01661764|O5|Outcome|rs174535 (TT), Fish Oil Supplement|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174289|NCT01661764|O4|Outcome|rs174535 (GT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174290|NCT01661764|O3|Outcome|rs174535 (GT), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174291|NCT01661764|O2|Outcome|rs174535 (GG), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174292|NCT01661764|O1|Outcome|rs174535 (GG), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174293|NCT01661764|O6|Outcome|rs174535 (TT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174294|NCT01661764|O5|Outcome|rs174535 (TT), Fish Oil Supplement|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174295|NCT01661764|O4|Outcome|rs174535 (GT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174296|NCT01661764|O3|Outcome|rs174535 (GT), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174297|NCT01661764|O2|Outcome|rs174535 (GG), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174298|NCT01661764|O1|Outcome|rs174535 (GG), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174299|NCT01661764|O6|Outcome|rs174535 (TT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174300|NCT01661764|O5|Outcome|rs174535 (TT), Fish Oil Supplement|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174301|NCT01661764|O4|Outcome|rs174535 (GT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174302|NCT01661764|O3|Outcome|rs174535 (GT), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174303|NCT01661764|O2|Outcome|rs174535 (GG), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174304|NCT01661764|O1|Outcome|rs174535 (GG), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174305|NCT01661764|O6|Outcome|rs174535 (TT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174306|NCT01661764|O5|Outcome|rs174535 (TT), Fish Oil Supplement|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174307|NCT01661764|O4|Outcome|rs174535 (GT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174308|NCT01661764|O3|Outcome|rs174535 (GT), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174309|NCT01661764|O2|Outcome|rs174535 (GG), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174310|NCT01661764|O1|Outcome|rs174535 (GG), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174311|NCT01661764|O6|Outcome|rs174535 (TT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174312|NCT01661764|O5|Outcome|rs174535 (TT), Fish Oil Supplement|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174313|NCT01661764|O4|Outcome|rs174535 (GT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174314|NCT01661764|O3|Outcome|rs174535 (GT), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174315|NCT01661764|O2|Outcome|rs174535 (GG), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174316|NCT01661764|O1|Outcome|rs174535 (GG), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174317|NCT01661764|O6|Outcome|rs174535 (TT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174318|NCT01661764|O5|Outcome|rs174535 (TT), Fish Oil Supplement|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174319|NCT01661764|O4|Outcome|rs174535 (GT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174320|NCT01661764|O3|Outcome|rs174535 (GT), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174321|NCT01661764|O2|Outcome|rs174535 (GG), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174322|NCT01661764|O1|Outcome|rs174535 (GG), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174323|NCT01661764|E6|Reported Event|rs174535 (TT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174324|NCT01661764|E5|Reported Event|rs174535 (TT), Fish Oil Supplement|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174325|NCT01661764|E4|Reported Event|rs174535 (GT), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174326|NCT01661764|E3|Reported Event|rs174535 (GT), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174327|NCT01661764|E2|Reported Event|rs174535 (GG), Placebo|"Oleic Acid~Oleic Acid: Placebo"
174328|NCT01661764|E1|Reported Event|rs174535 (GG), Fish Oil Supplements|"Eicosapentanoic acid and docosahexanoic acid~Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks"
174329|NCT01661621|B3|Baseline|Total|Total of all reporting groups
174330|NCT01661621|B2|Baseline|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
174331|NCT01661621|B1|Baseline|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
174332|NCT01661621|P2|Participant Flow|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
174333|NCT01661621|P1|Participant Flow|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
174334|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
174335|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
174336|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
174337|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
174338|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
174339|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
174340|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
174341|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
174342|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
174343|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
174344|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
174345|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
174346|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
174347|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
174348|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
174349|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
174350|NCT01661621|E2|Reported Event|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
174351|NCT01661621|E1|Reported Event|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
174352|NCT01661270|B3|Baseline|Total|Total of all reporting groups
174353|NCT01661270|B2|Baseline|Aflibercept|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
174354|NCT01661270|B1|Baseline|Placebo|Placebo for IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
174355|NCT01661270|P2|Participant Flow|Aflibercept|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
174356|NCT01661270|P1|Participant Flow|Placebo|Placebo for aflibercept intravenous (IV) infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
174357|NCT01661270|O2|Outcome|Aflibercept|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
174358|NCT01661270|O1|Outcome|Placebo|Placebo for IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
174359|NCT01661270|O2|Outcome|Aflibercept|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
174360|NCT01661270|O1|Outcome|Placebo|Placebo for IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
174361|NCT01661270|O2|Outcome|Aflibercept|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
174426|NCT01661114|O1|Outcome|Gemcitabine, 5-FU and Cisplatin|4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
174362|NCT01661270|O1|Outcome|Placebo|Placebo for IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
174363|NCT01661270|E3|Reported Event|Mixed Administration (Placebo and Aflibercept)|Participants who were originally randomized to receive either Placebo or Aflibercept, actually received both the treatment (Placebo and Aflibercept).
174364|NCT01661270|E2|Reported Event|Aflibercept Only|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
174365|NCT01661270|E1|Reported Event|Placebo Only|Placebo for IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
174366|NCT01661205|B1|Baseline|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart~Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
174367|NCT01661205|P1|Participant Flow|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart~Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
174368|NCT01661205|O1|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart~Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
174369|NCT01661205|O1|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart~Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
174370|NCT01661205|O1|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart~Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
174371|NCT01661205|O1|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart~Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
174372|NCT01661205|O1|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart~Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
174373|NCT01661205|O1|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart~Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
174374|NCT01661205|O1|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart~Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
174375|NCT01661205|O1|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart~Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
174376|NCT01661205|E1|Reported Event|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart~Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
174377|NCT01661179|B1|Baseline|Vandetanib 300 mg|Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
174378|NCT01661179|P1|Participant Flow|Vandetanib 300 mg|Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
174379|NCT01661179|O1|Outcome|Vandetanib 300 mg|Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
174380|NCT01661179|E1|Reported Event|Vandetanib 300 mg|Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
174381|NCT01661140|B1|Baseline|Initial Phase|At Week 0 participants started open-label tocilizumab and open-label MTX for 24 weeks.
174382|NCT01661140|P3|Participant Flow|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174383|NCT01661140|P2|Participant Flow|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174385|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174386|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174387|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174388|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174389|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174390|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174391|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174392|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174393|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174394|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174395|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174396|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174397|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
184011|NCT01626118|O4|Outcome|Placebo|Placebo Group
174398|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174399|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174400|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174401|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174402|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174403|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174404|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174405|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174406|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174407|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174408|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174409|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174410|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
185375|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
174411|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174412|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174413|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy..
174414|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174415|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174416|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174417|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174418|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174419|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174420|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
174421|NCT01661140|E3|Reported Event|Methotrexate (MTX) Maintenance Group|"After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.~Adverse events in this reporting group are those occurring in the double-blind phase only."
174422|NCT01661140|E2|Reported Event|Methotrexate (MTX) Tapering Group|"After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.~Adverse events in this reporting group are those occurring in the double-blind phase only."
174423|NCT01661140|E1|Reported Event|Initial Phase|"At Week 0 participants will start open-label tocilizumab and open-label MTX for 24 weeks, which is the initial phase of the study.~Adverse events in this reporting group are those occurring in the open-label phase only."
174424|NCT01661114|B1|Baseline|Gemcitabine, 5-FU and Cisplatin|4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
174427|NCT01661114|O1|Outcome|Gemcitabine, 5-FU and Cisplatin|4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
174428|NCT01661114|E1|Reported Event|Gemcitabine, 5-FU and Cisplatin|4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
174429|NCT01661062|B1|Baseline|Cone Beam CT|"For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).~Radiotherapy will be delivered according to current guidelines.~Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy."
174430|NCT01661062|P1|Participant Flow|Cone Beam CT|"For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).~Radiotherapy will be delivered according to current guidelines.~Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy."
174431|NCT01661062|O1|Outcome|Cone Beam CT|"For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).~Radiotherapy will be delivered according to current guidelines.~Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy."
174432|NCT01661062|O1|Outcome|Cone Beam CT|"For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).~Radiotherapy will be delivered according to current guidelines.~Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy."
174433|NCT01661062|E1|Reported Event|Cone Beam CT|"For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).~Radiotherapy will be delivered according to current guidelines.~Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy."
174434|NCT01660906|B1|Baseline|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
174435|NCT01660906|P1|Participant Flow|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
174436|NCT01660906|O1|Outcome|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
174437|NCT01660906|O1|Outcome|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
174438|NCT01660906|O1|Outcome|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
174439|NCT01660906|O1|Outcome|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
174440|NCT01660906|O1|Outcome|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
174441|NCT01660906|O1|Outcome|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
174442|NCT01660906|E1|Reported Event|Dasatinib|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
174443|NCT01660893|B4|Baseline|Total|Total of all reporting groups
174444|NCT01660893|B3|Baseline|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
174445|NCT01660893|B2|Baseline|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
174446|NCT01660893|B1|Baseline|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and oxymetazoline HCl 0.05%~Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
174447|NCT01660893|P3|Participant Flow|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
174448|NCT01660893|P2|Participant Flow|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
174449|NCT01660893|P1|Participant Flow|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and oxymetazoline HCl 0.05%~Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
174450|NCT01660893|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
174451|NCT01660893|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
174452|NCT01660893|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and oxymetazoline HCl 0.05%~Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
174453|NCT01660893|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
174454|NCT01660893|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
174455|NCT01660893|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and oxymetazoline HCl 0.05%~Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
174456|NCT01660893|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
174457|NCT01660893|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
174458|NCT01660893|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and oxymetazoline HCl 0.05%~Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
174459|NCT01660893|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
174460|NCT01660893|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
174461|NCT01660893|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and oxymetazoline HCl 0.05%~Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
174462|NCT01660893|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
174464|NCT01660893|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and oxymetazoline HCl 0.05%~Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
174465|NCT01660893|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
174466|NCT01660893|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
174467|NCT01660893|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and oxymetazoline HCl 0.05%~Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
174468|NCT01660893|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
174469|NCT01660893|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
174470|NCT01660893|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and oxymetazoline HCl 0.05%~Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
174471|NCT01660893|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
174472|NCT01660893|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
174473|NCT01660893|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and oxymetazoline HCl 0.05%~Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
174474|NCT01660893|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
174475|NCT01660893|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
174476|NCT01660893|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and oxymetazoline HCl 0.05%~Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
174477|NCT01660893|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
174478|NCT01660893|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
174479|NCT01660893|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and oxymetazoline HCl 0.05%~Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
174480|NCT01660893|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
174481|NCT01660893|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
174482|NCT01660893|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and oxymetazoline HCl 0.05%~Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
174483|NCT01660893|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
174484|NCT01660893|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
174485|NCT01660893|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and oxymetazoline HCl 0.05%~Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
174486|NCT01660893|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
174487|NCT01660893|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
174488|NCT01660893|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and oxymetazoline HCl 0.05%~Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
174489|NCT01660893|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
174490|NCT01660893|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
174491|NCT01660893|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and oxymetazoline HCl 0.05%~Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
174492|NCT01660893|E3|Reported Event|Placebo, 3 Sprays Unilateral|"Placebo~Placebo: 3 unilateral intranasal sprays per dose"
174493|NCT01660893|E2|Reported Event|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%~Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
174494|NCT01660893|E1|Reported Event|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and oxymetazoline HCl 0.05%~Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
174495|NCT01660815|B1|Baseline|Healthy Volunteers|"Cognitively normal, healthy volunteers at least 45 years of age.~florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose"
174496|NCT01660815|P1|Participant Flow|Healthy Volunteers|"Cognitively normal, healthy volunteers at least 45 years of age.~florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose"
174497|NCT01660815|O2|Outcome|70-kg Model|Radiation dose estimate using a 70-kg model.
174498|NCT01660815|O1|Outcome|50-kg Model|Radiation dose estimate using a 50-kg model.
174499|NCT01660815|E1|Reported Event|Healthy Volunteers|"Cognitively normal, healthy volunteers at least 45 years of age.~florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose"
174500|NCT01660802|B3|Baseline|Total|Total of all reporting groups
174501|NCT01660802|B2|Baseline|Sham|Sham administered in the study eye on Day 1.
174502|NCT01660802|B1|Baseline|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
174503|NCT01660802|P2|Participant Flow|Sham|Sham administered in the study eye on Day 1.
174504|NCT01660802|P1|Participant Flow|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
174505|NCT01660802|O2|Outcome|Sham|Sham administered in the study eye on Day 1.
174506|NCT01660802|O1|Outcome|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
174507|NCT01660802|O2|Outcome|Sham|Sham administered in the study eye on Day 1.
174508|NCT01660802|O1|Outcome|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
174509|NCT01660802|O2|Outcome|Sham|Sham administered in the study eye on Day 1.
174510|NCT01660802|O1|Outcome|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
174511|NCT01660802|O2|Outcome|Sham|Sham administered in the study eye on Day 1.
174516|NCT01660763|B2|Baseline|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
174517|NCT01660763|B1|Baseline|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
174518|NCT01660763|P2|Participant Flow|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
174519|NCT01660763|P1|Participant Flow|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
174520|NCT01660763|O2|Outcome|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System/15 mcg : Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patients may elect to remain in study for up to 72 hours.
174521|NCT01660763|O1|Outcome|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patients may elect to remain in study for up to 72 hours.
174522|NCT01660763|E2|Reported Event|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System/15 mcg : Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patients may elect to remain in study for up to 72 hours.
174523|NCT01660763|E1|Reported Event|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patients may elect to remain in study for up to 72 hours.
174524|NCT01660737|B1|Baseline|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
174525|NCT01660737|P1|Participant Flow|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
174526|NCT01660737|O1|Outcome|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
174527|NCT01660737|O1|Outcome|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
174528|NCT01660737|O1|Outcome|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
174529|NCT01660737|O1|Outcome|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
174530|NCT01660737|O1|Outcome|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
174531|NCT01660737|O1|Outcome|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
174532|NCT01660737|O1|Outcome|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
174533|NCT01660737|O1|Outcome|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
174534|NCT01660737|O1|Outcome|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
174535|NCT01660737|O1|Outcome|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
174536|NCT01660737|O1|Outcome|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
174537|NCT01660737|O1|Outcome|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
174538|NCT01660737|E1|Reported Event|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
174539|NCT01660698|B3|Baseline|Total|Total of all reporting groups
174540|NCT01660698|B2|Baseline|Probiotic|"probiotic blended in maltodextrin~Probiotic : probiotic blended in maltodextrin powder"
174541|NCT01660698|B1|Baseline|Placebo|"maltodextrin powder~Maltodextrin : maltodextrin powder"
174542|NCT01660698|P2|Participant Flow|Probiotic|"probiotic blended in maltodextrin~Probiotic : probiotic blended in maltodextrin powder"
174543|NCT01660698|P1|Participant Flow|Placebo|"maltodextrin powder~Maltodextrin : maltodextrin powder"
174544|NCT01660698|O2|Outcome|Probiotic|"probiotic blended in maltodextrin~Probiotic : probiotic blended in maltodextrin powder"
174545|NCT01660698|O1|Outcome|Placebo|"maltodextrin powder~Maltodextrin : maltodextrin powder"
174546|NCT01660698|O2|Outcome|Probiotic|"probiotic blended in maltodextrin~Probiotic : probiotic blended in maltodextrin powder"
174547|NCT01660698|O1|Outcome|Placebo|"maltodextrin powder~Maltodextrin : maltodextrin powder"
174548|NCT01660698|O2|Outcome|Probiotic|"probiotic blended in maltodextrin~Probiotic : probiotic blended in maltodextrin powder"
174549|NCT01660698|O1|Outcome|Placebo|"maltodextrin powder~Maltodextrin : maltodextrin powder"
174550|NCT01660698|E2|Reported Event|Probiotic|"probiotic blended in maltodextrin~Probiotic : probiotic blended in maltodextrin powder"
174551|NCT01660698|E1|Reported Event|Placebo|"maltodextrin powder~Maltodextrin : maltodextrin powder"
174552|NCT01660672|B1|Baseline|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted."
174606|NCT01660334|O1|Outcome|Voriconazole for Scedosporium Disease|Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
178704|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
174553|NCT01660672|P1|Participant Flow|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted."
174554|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted."
174555|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted."
174556|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose."
174557|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted."
174558|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose."
174559|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose."
174560|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose."
174561|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose."
174562|NCT01660672|E1|Reported Event|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. This dose was effective in 7/7 children."
174563|NCT01660451|B4|Baseline|Total|Total of all reporting groups
174564|NCT01660451|B3|Baseline|Part B: Indolent NHL|Participants with indolent B-cell NHL received copanlisib 60 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174565|NCT01660451|B2|Baseline|Part A: Aggressive NHL|Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174566|NCT01660451|B1|Baseline|Part A: Indolent NHL/CLL|Participants with indolent Non-Hodgkin’s lymphoma/Chronic lymphocytic leukemia [iNHL/CLL] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174567|NCT01660451|P3|Participant Flow|Part B: Indolent NHL|Participants with indolent B-cell NHL received copanlisib 60 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174568|NCT01660451|P2|Participant Flow|Part A: Aggressive NHL|Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174569|NCT01660451|P1|Participant Flow|Part A: Indolent NHL/CLL|Participants with indolent Non-Hodgkin’s lymphoma/Chronic lymphocytic leukemia [iNHL/CLL] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174570|NCT01660451|O1|Outcome|Part B: Indolent NHL|Participants with indolent B-cell NHL received copanlisib 60 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174571|NCT01660451|O1|Outcome|Part B: Indolent NHL|Participants with indolent B-cell NHL received copanlisib 60 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174572|NCT01660451|O3|Outcome|Part B: Indolent NHL|Participants with indolent B-cell NHL received copanlisib 60 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174573|NCT01660451|O2|Outcome|Part A: Aggressive NHL|Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174574|NCT01660451|O1|Outcome|Part A: Indolent NHL/CLL|Participants with indolent Non-Hodgkin’s lymphoma/Chronic lymphocytic leukemia [iNHL/CLL] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174575|NCT01660451|O3|Outcome|Part B: Indolent NHL|Participants with indolent B-cell NHL received copanlisib 60 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174576|NCT01660451|O2|Outcome|Part A: Aggressive NHL|Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174577|NCT01660451|O1|Outcome|Part A: Indolent NHL/CLL|Participants with indolent Non-Hodgkin’s lymphoma/Chronic lymphocytic leukemia [iNHL/CLL] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174578|NCT01660451|O3|Outcome|Part B: Indolent NHL|Participants with indolent B-cell NHL received copanlisib 60 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174579|NCT01660451|O2|Outcome|Part A: Aggressive NHL|Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174580|NCT01660451|O1|Outcome|Part A: Indolent NHL/CLL|Participants with indolent Non-Hodgkin’s lymphoma/Chronic lymphocytic leukemia [iNHL/CLL] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174581|NCT01660451|O3|Outcome|Part B: Indolent NHL|Participants with indolent B-cell NHL received copanlisib 60 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174582|NCT01660451|O2|Outcome|Part A: Aggressive NHL|Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174583|NCT01660451|O1|Outcome|Part A: Indolent NHL/CLL|Participants with indolent Non-Hodgkin’s lymphoma/Chronic lymphocytic leukemia [iNHL/CLL] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174584|NCT01660451|O3|Outcome|Part B: Indolent NHL|Participants with indolent B-cell NHL received copanlisib 60 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174585|NCT01660451|O2|Outcome|Part A: Aggressive NHL|Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174586|NCT01660451|O1|Outcome|Part A: Indolent NHL/CLL|Participants with indolent Non-Hodgkin’s lymphoma/Chronic lymphocytic leukemia [iNHL/CLL] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174587|NCT01660451|O1|Outcome|Part B: Indolent NHL|Participants with indolent B-cell NHL received copanlisib 60 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174588|NCT01660451|O2|Outcome|Part A: Aggressive NHL|Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174589|NCT01660451|O1|Outcome|Part A: Indolent NHL/CLL|Participants with indolent Non-Hodgkin’s lymphoma/Chronic lymphocytic leukemia [iNHL/CLL] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174590|NCT01660451|O1|Outcome|Part B: Indolent NHL|Participants with indolent B-cell NHL received copanlisib 60 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174591|NCT01660451|O2|Outcome|Part A: Aggressive NHL|Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174592|NCT01660451|O1|Outcome|Part A: Indolent NHL/CLL|Participants with indolent Non-Hodgkin’s lymphoma/Chronic lymphocytic leukemia [iNHL/CLL] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174593|NCT01660451|E3|Reported Event|Part B: Indolent NHL|Participants with indolent B-cell NHL received copanlisib 60 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174594|NCT01660451|E2|Reported Event|Part A: Aggressive NHL|Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174595|NCT01660451|E1|Reported Event|Part A: Indolent NHL/CLL|Participants with indolent Non-Hodgkin’s lymphoma/Chronic lymphocytic leukemia [iNHL/CLL] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
174596|NCT01660412|B1|Baseline|All Study Participants|"Subjects were randomized into 1 of 2 sequence groups (A and B):~Sequence group A. The first injection administered was the standard-of-care (SOC) solution followed by the pH-altered solution. The remaining injections were randomly assigned as either SOC solution or pH-altered.~Sequence group B. The first injection administered was the pHaltered solution followed by the SOC solution. The remaining injections were randomly assigned as either SOC solution or pH-altered."
174597|NCT01660412|P2|Participant Flow|Standard of Care First|"The first injection administered will be the standard of care solution (SOC). The second injection will be the pH altered solution. The remaining injections will be randomly assigned as either standard of care or pH altered.~Standard of Care First: For the second injection, and randomly after that, Sodium Bicarbonate will be compounded with Tc-99m SC, to raise the pH up to ~7.40."
174598|NCT01660412|P1|Participant Flow|pH Altered First|"The first injection administered will be the pH altered solution. The second injection will be the standard of care solution (opposite order). The remaining injections will be randomly assigned as either standard of care or pH altered.~ph Altered first: For the first injection, Sodium Bicarbonate will be compounded with Tc-99m SC, to raise the pH up to ~7.40. For the second injection, the standard of care will be given, and randomly after that either standard of care, or pH altered will be given."
174599|NCT01660412|O2|Outcome|PH Altered Injection|a diluted bicarbonate solution in a drop wise manner to raise the pH of the 99mTc-SC to a pH of 7.40 ± 0.05, dose Approximately 1mc
174600|NCT01660412|O1|Outcome|Standard of Care Injection|Approximately 1mc 99mTc-SC
174601|NCT01660412|E2|Reported Event|PH Altered Injection|a diluted bicarbonate solution in a drop wise manner to raise the pH of the 99mTc-SC to a pH of 7.40 ± 0.05, dose Approximately 1mc
174602|NCT01660412|E1|Reported Event|Standard of Care Injection|Approximately 1mc 99mTc-SC
174603|NCT01660334|B1|Baseline|Voriconazole for Scedosporium Disease|Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
174604|NCT01660334|P1|Participant Flow|Voriconazole for Scedosporium Disease|Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
174605|NCT01660334|O1|Outcome|Voriconazole for Scedosporium Disease|Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
174607|NCT01660334|E1|Reported Event|Voriconazole for Scedosporium Disease|Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
174608|NCT01660321|B1|Baseline|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
174609|NCT01660321|P1|Participant Flow|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
174610|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
174611|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
174612|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
174613|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
174614|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
174615|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
174616|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
174617|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
174618|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
174619|NCT01660321|E1|Reported Event|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
174620|NCT01660230|B13|Baseline|Total|Total of all reporting groups
174621|NCT01660230|B12|Baseline|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
174622|NCT01660230|B11|Baseline|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174623|NCT01660230|B10|Baseline|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174624|NCT01660230|B9|Baseline|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174625|NCT01660230|B8|Baseline|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174626|NCT01660230|B7|Baseline|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174627|NCT01660230|B6|Baseline|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174628|NCT01660230|B5|Baseline|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174629|NCT01660230|B4|Baseline|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174630|NCT01660230|B3|Baseline|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174631|NCT01660230|B2|Baseline|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174632|NCT01660230|B1|Baseline|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174633|NCT01660230|P12|Participant Flow|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
174634|NCT01660230|P11|Participant Flow|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174635|NCT01660230|P10|Participant Flow|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174636|NCT01660230|P9|Participant Flow|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174637|NCT01660230|P8|Participant Flow|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174638|NCT01660230|P7|Participant Flow|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174639|NCT01660230|P6|Participant Flow|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174640|NCT01660230|P5|Participant Flow|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174641|NCT01660230|P4|Participant Flow|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174867|NCT01660022|O6|Outcome|Cohort 3 - OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
185376|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
174642|NCT01660230|P3|Participant Flow|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174643|NCT01660230|P2|Participant Flow|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174644|NCT01660230|P1|Participant Flow|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174645|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes~0.9% NaCl in water"
174646|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174647|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174648|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174649|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174650|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes~0.9% NaCl in water"
174651|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174652|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174653|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174654|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174655|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes~0.9% NaCl in water"
174656|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174657|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174658|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174659|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174660|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes~0.9% NaCl in water"
174661|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174662|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174663|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174664|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174665|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes~0.9% NaCl in water"
174666|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174667|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174668|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174868|NCT01660022|O5|Outcome|Cohort 3 - OZ439 100mg|Cohort 3 - Sequence 1 OZ439 100mg
179082|NCT01644240|B2|Baseline|Placebo|Placebo - saline: Intravenous infusion
174669|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174670|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes~0.9% NaCl in water"
174671|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174672|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174673|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174674|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174675|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
174676|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174677|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174678|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174679|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174680|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174681|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174682|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174683|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
174684|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174685|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174686|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174687|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174688|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174689|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174690|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174691|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
174692|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174693|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174694|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174695|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174696|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
179083|NCT01644240|B1|Baseline|TD-8954 Dose 1|TD-8954: Intravenous infusion
174697|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174698|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174699|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
174700|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174701|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174702|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174703|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174704|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174705|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174706|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174707|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
174708|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174709|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174710|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174711|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174712|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174713|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174714|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174715|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
174716|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174717|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174718|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174719|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174720|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174721|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174722|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174723|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
174724|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174869|NCT01660022|O4|Outcome|Cohort 2 - OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
185377|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
174725|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174726|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174727|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174728|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174729|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174730|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174731|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
174732|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174733|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174734|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174735|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174736|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174737|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174738|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174739|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
174740|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174741|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174742|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174743|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174744|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174745|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174746|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174747|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
174748|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174749|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174750|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174751|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174752|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174870|NCT01660022|O3|Outcome|Cohort 2 - OZ439 100mg|Cohort 2 - Sequence 1 OZ439 100mg
179084|NCT01644240|P3|Participant Flow|TD-8954 Dose 2|TD-8954: Intravenous infusion
174753|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174754|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174755|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
174756|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174757|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174758|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174759|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174760|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174761|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174762|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174763|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
174764|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174765|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174766|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174767|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174768|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174769|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174770|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174771|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
174772|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174773|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174774|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174775|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174776|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174777|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174778|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174779|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
174780|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174871|NCT01660022|O2|Outcome|Cohort 1 - OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
185378|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
174781|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174782|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174783|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174784|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174785|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174786|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174787|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes~0.9% NaCl in water"
174788|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174789|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174790|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174791|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174792|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
174793|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174794|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174795|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174796|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174797|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174798|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174799|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174800|NCT01660230|E12|Reported Event|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
174801|NCT01660230|E11|Reported Event|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174802|NCT01660230|E10|Reported Event|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174803|NCT01660230|E9|Reported Event|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174804|NCT01660230|E8|Reported Event|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
174805|NCT01660230|E7|Reported Event|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174806|NCT01660230|E6|Reported Event|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174807|NCT01660230|E5|Reported Event|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174872|NCT01660022|O1|Outcome|Cohort 1 - OZ439 100mg|Cohort 1 - Sequence 1 OZ439 100mg
174873|NCT01660022|O10|Outcome|Cohort 5 - OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
174808|NCT01660230|E4|Reported Event|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174809|NCT01660230|E3|Reported Event|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174810|NCT01660230|E2|Reported Event|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174811|NCT01660230|E1|Reported Event|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
174812|NCT01660191|B4|Baseline|Total|Total of all reporting groups
174813|NCT01660191|B3|Baseline|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
174814|NCT01660191|B2|Baseline|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
174815|NCT01660191|B1|Baseline|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
174816|NCT01660191|P3|Participant Flow|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
174817|NCT01660191|P2|Participant Flow|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
174818|NCT01660191|P1|Participant Flow|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
174819|NCT01660191|O3|Outcome|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
174820|NCT01660191|O2|Outcome|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
174821|NCT01660191|O1|Outcome|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
174822|NCT01660191|O3|Outcome|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
174823|NCT01660191|O2|Outcome|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
174824|NCT01660191|O1|Outcome|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
174825|NCT01660191|O3|Outcome|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
174826|NCT01660191|O2|Outcome|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
174827|NCT01660191|O1|Outcome|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
174828|NCT01660191|O3|Outcome|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
174829|NCT01660191|O2|Outcome|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
174830|NCT01660191|O1|Outcome|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
174831|NCT01660191|O3|Outcome|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
174832|NCT01660191|O2|Outcome|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
174833|NCT01660191|O1|Outcome|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
174834|NCT01660191|O3|Outcome|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
174835|NCT01660191|O2|Outcome|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
174836|NCT01660191|O1|Outcome|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
174837|NCT01660191|E3|Reported Event|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
174838|NCT01660191|E2|Reported Event|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
174839|NCT01660191|E1|Reported Event|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
174840|NCT01660022|B7|Baseline|Total|Total of all reporting groups
174841|NCT01660022|B6|Baseline|Placebo|Cohorts 1, 2, 3, 4 and 5
174842|NCT01660022|B5|Baseline|Cohort 5|Sequence 1: OZ439 800mg Sequence 2: OZ439 800 mg / PQP 1440 mg
174843|NCT01660022|B4|Baseline|Cohort 4|Sequence 1: OZ439 300mg Sequence 2: OZ439 300 mg / PQP 1440 mg
174844|NCT01660022|B3|Baseline|Cohort 3|Sequence 1: OZ439 100mg Sequence 2: OZ439 100 mg / PQP 1440 mg
174845|NCT01660022|B2|Baseline|Cohort 2|Sequence 1: OZ439 100mg Sequence 2: OZ439 100 mg / PQP 480 mg
174846|NCT01660022|B1|Baseline|Cohort 1|Sequence 1: OZ439 100mg Sequence 2: OZ439 100 mg / PQP 160 mg
174847|NCT01660022|P6|Participant Flow|Placebo|Cohorts 1, 2, 3, 4 and 5
174848|NCT01660022|P5|Participant Flow|Cohort 5|Sequence 1: OZ439 800mg Sequence 2: OZ439 800mg+PQP 1440mg
174849|NCT01660022|P4|Participant Flow|Cohort 4|Sequence 1: OZ439 300mg Sequence 2: OZ439 300mg+PQP 1440mg
174850|NCT01660022|P3|Participant Flow|Cohort 3|Sequence 1: OZ439 100mg Sequence 2: OZ439 100mg+PQP 1440mg
174851|NCT01660022|P2|Participant Flow|Cohort 2|Sequence 1: OZ439 100mg Sequence 2: OZ439 100mg+PQP 480mg
174852|NCT01660022|P1|Participant Flow|Cohort 1|Sequence 1: OZ439 100mg Sequence 2: OZ439 100mg / PQP 160mg
174853|NCT01660022|O5|Outcome|OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
174854|NCT01660022|O4|Outcome|OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
174855|NCT01660022|O3|Outcome|OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
174856|NCT01660022|O2|Outcome|OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
174857|NCT01660022|O1|Outcome|OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
174858|NCT01660022|O5|Outcome|OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
174859|NCT01660022|O4|Outcome|OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
174860|NCT01660022|O3|Outcome|OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
174861|NCT01660022|O2|Outcome|OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
174862|NCT01660022|O1|Outcome|OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
174863|NCT01660022|O10|Outcome|Cohort 5 - OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
174864|NCT01660022|O9|Outcome|Cohort 5 - OZ439 800mg|Cohort 5 - Sequence 1 OZ439 800mg
174865|NCT01660022|O8|Outcome|Cohort 4 - OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
174866|NCT01660022|O7|Outcome|Cohort 4 - OZ439 300mg|Cohort 4 - Sequence 1 OZ439 300mg
174875|NCT01660022|O8|Outcome|Cohort 4 - OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
174876|NCT01660022|O7|Outcome|Cohort 4 - OZ439 300mg|Cohort 4 - Sequence 1 OZ439 300mg
174877|NCT01660022|O6|Outcome|Cohort 3 - OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
174878|NCT01660022|O5|Outcome|Cohort 3 - OZ439 100mg|Cohort 3 - Sequence 1 OZ439 100mg
174879|NCT01660022|O4|Outcome|Cohort 2 - OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
174880|NCT01660022|O3|Outcome|Cohort 2 - OZ439 100mg|Cohort 2 - Sequence 1 OZ439 100mg
174881|NCT01660022|O2|Outcome|Cohort 1 - OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
174882|NCT01660022|O1|Outcome|Cohort 1 - OZ439 100mg|Cohort 1 - Sequence 1 OZ439 100mg
174883|NCT01660022|O5|Outcome|OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
174884|NCT01660022|O4|Outcome|OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
174885|NCT01660022|O3|Outcome|OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
174886|NCT01660022|O2|Outcome|OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
174887|NCT01660022|O1|Outcome|OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
174888|NCT01660022|O10|Outcome|Cohort 5 - OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
174889|NCT01660022|O9|Outcome|Cohort 5 - OZ439 800mg|Cohort 5 - Sequence 1 OZ439 800mg
174890|NCT01660022|O8|Outcome|Cohort 4 - OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
174891|NCT01660022|O7|Outcome|Cohort 4 - OZ439 300mg|Cohort 4 - Sequence 1 OZ439 300mg
174892|NCT01660022|O6|Outcome|Cohort 3 - OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
174893|NCT01660022|O5|Outcome|Cohort 3 - OZ439 100mg|Cohort 3 - Sequence 1 OZ439 100mg
174894|NCT01660022|O4|Outcome|Cohort 2 - OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
174895|NCT01660022|O3|Outcome|Cohort 2 - OZ439 100mg|Cohort 2 - Sequence 1 OZ439 100mg
174896|NCT01660022|O2|Outcome|Cohort 1 - OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
174897|NCT01660022|O1|Outcome|Cohort 1 - OZ439 100mg|Cohort 1 - Sequence 1 OZ439 100mg
174898|NCT01660022|E9|Reported Event|Placebo|Cohorts 1, 2, 3, 4 and 5
174899|NCT01660022|E8|Reported Event|OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
174900|NCT01660022|E7|Reported Event|OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
174901|NCT01660022|E6|Reported Event|OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
174902|NCT01660022|E5|Reported Event|OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
174903|NCT01660022|E4|Reported Event|OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
174904|NCT01660022|E3|Reported Event|OZ439 800mg|Cohort 5 - Sequence 1 OZ439 800mg
174905|NCT01660022|E2|Reported Event|OZ439 300mg|Cohort 4 - Sequence 1 OZ439 300mg
174906|NCT01660022|E1|Reported Event|OZ439 100mg|Cohorts 1, 2 and 3 OZ439 100mg
174907|NCT01659996|B4|Baseline|Total|Total of all reporting groups
174908|NCT01659996|B3|Baseline|Pentacel Vaccine Group|Study participants received only Pentacel vaccine at 15 to 18 months of age
174909|NCT01659996|B2|Baseline|Menactra + Pentacel Vaccine Group|Study participants received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months
174910|NCT01659996|B1|Baseline|Menactra Vaccine Group|Study participants received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
174911|NCT01659996|P3|Participant Flow|Pentacel Vaccine Group|Study participants received only Pentacel vaccine at 15 to 18 months of age
174912|NCT01659996|P2|Participant Flow|Menactra + Pentacel Vaccine Group|All participants received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
174913|NCT01659996|P1|Participant Flow|Menactra Vaccine Group|All participants received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
174914|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age
174915|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
174916|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
174917|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age.
174918|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
174919|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.
174920|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age
174921|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
174922|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
174923|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age
174924|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
174925|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
174926|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age.
174927|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
174928|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.
174929|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age.
174930|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
174931|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.
174932|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age
174933|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
174934|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
174935|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age
174936|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
174937|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
174938|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age
174939|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
174940|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.
174941|NCT01659996|E3|Reported Event|Pentacel Vaccine Group|Study participants received only Pentacel vaccine at 15 to 18 months of age
174942|NCT01659996|E2|Reported Event|Menactra + Pentacel Vaccine Group|Study participants received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months
174943|NCT01659996|E1|Reported Event|Menactra Vaccine Group|Study participants received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
174944|NCT01659853|B1|Baseline|Overall Study|"Participants were randomly assigned to treatment sequence.~Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2.~Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2.~Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information."
174945|NCT01659853|P2|Participant Flow|Azelaic Acid Gel 15%, Then CD07805/47 Gel 0.5% and Vehicle|"Subjects were randomly assigned to treatment sequence.~Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) will switch to azelaic acid gel in Period 2.~Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in period 2.~Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information."
174946|NCT01659853|P1|Participant Flow|CD07805/47 Gel 0.5% and Vehicle, Then Azelaic Acid Gel 15%|"Subjects were randomly assigned to treatment sequence.~Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) will switch to azelaic acid gel in Period 2.~Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in period 2.~Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information."
174947|NCT01659853|O2|Outcome|Azelaic Acid 15%|"Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.~A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed."
174948|NCT01659853|O1|Outcome|CD07805/47 Gel 0.5 and Vehicle|"Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.~A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed."
174949|NCT01659853|O2|Outcome|Azelaic Acid Gel 15%|"Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.~A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed."
174950|NCT01659853|O1|Outcome|CD07805/47 Gel 0.5% and Vehicle|"Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.~A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed."
174951|NCT01659853|E2|Reported Event|Azelaic Acid 15%|"Participants were randomly assigned to treatment sequence.~Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2.~Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2.~Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information."
174952|NCT01659853|E1|Reported Event|CD07805/47 Gel 0.5 and Vehicle|"Participants were randomly assigned to treatment sequence.~Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2.~Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2.~Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information."
174953|NCT01659736|B3|Baseline|Total|Total of all reporting groups
174954|NCT01659736|B2|Baseline|TMS-Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
174955|NCT01659736|B1|Baseline|TMS Therapy|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
174956|NCT01659736|P2|Participant Flow|TMS-Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
174957|NCT01659736|P1|Participant Flow|TMS-Treatment|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
174958|NCT01659736|O2|Outcome|TMS-Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
174959|NCT01659736|O1|Outcome|TMS-Treatment|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
174960|NCT01659736|O2|Outcome|TMS-Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
174961|NCT01659736|O1|Outcome|TMS-Treatment|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
174962|NCT01659736|O2|Outcome|TMS-Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
174963|NCT01659736|O1|Outcome|TMS-Treatment|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
174964|NCT01659736|O2|Outcome|TMS- Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
174965|NCT01659736|O1|Outcome|TMS- Treatment|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
174966|NCT01659736|O2|Outcome|TMS-Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
174967|NCT01659736|O1|Outcome|TMS-Treatment|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
174968|NCT01659736|E2|Reported Event|TMS-Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
174969|NCT01659736|E1|Reported Event|TMS-Treatment|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
174970|NCT01659567|B1|Baseline|Pegylated Interferon Alfa-2a and Ribavirin|Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
174971|NCT01659567|P1|Participant Flow|Pegylated Interferon Alfa-2a and Ribavirin|Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
174972|NCT01659567|O1|Outcome|Pegylated Interferon Alfa-2a and Ribavirin|Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
174973|NCT01659567|O1|Outcome|Pegylated Interferon Alfa-2a and Ribavirin|Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
174974|NCT01659567|O1|Outcome|Pegylated Interferon Alfa-2a and Ribavirin|Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
174975|NCT01659567|O1|Outcome|Pegylated Interferon Alfa-2a and Ribavirin|Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
174976|NCT01659567|O1|Outcome|Pegylated Interferon Alfa-2a and Ribavirin|Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
174977|NCT01659567|O1|Outcome|Pegylated Interferon Alfa-2a and Ribavirin|Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
175076|NCT01658839|O1|Outcome|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
174978|NCT01659567|O1|Outcome|Pegylated Interferon Alfa-2a and Ribavirin|Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
174979|NCT01659567|O1|Outcome|Pegylated Interferon Alfa-2a and Ribavirin|Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
174980|NCT01659567|O1|Outcome|Pegylated Interferon Alfa-2a and Ribavirin|Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
174981|NCT01659567|O1|Outcome|Pegylated Interferon Alfa-2a and Ribavirin|Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
174982|NCT01659567|O1|Outcome|Pegylated Interferon Alfa-2a and Ribavirin|Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
174983|NCT01659567|O1|Outcome|Pegylated Interferon Alfa-2a and Ribavirin|Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
174984|NCT01659567|O1|Outcome|Pegylated Interferon Alfa-2a and Ribavirin|Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
174985|NCT01659567|O1|Outcome|Pegylated Interferon Alfa-2a and Ribavirin|Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
174986|NCT01659567|E1|Reported Event|Pegylated Interferon Alfa-2a and Ribavirin|Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
174987|NCT01659554|B1|Baseline|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle~Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
174988|NCT01659554|P1|Participant Flow|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle~Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
174989|NCT01659554|O1|Outcome|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle~Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
174990|NCT01659554|O1|Outcome|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle~Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
174991|NCT01659554|O1|Outcome|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle~Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
174992|NCT01659554|O1|Outcome|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle~Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
174993|NCT01659554|E1|Reported Event|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle~Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
174994|NCT01659320|B1|Baseline|Minocycline|"Open label treatment using minocycline.~Minocycline: Minocycline 100 mg twice daily for 8 weeks"
174995|NCT01659320|P1|Participant Flow|Minocycline|"Open label treatment using minocycline.~Minocycline: Minocycline 100 mg twice daily for 8 weeks"
174996|NCT01659320|O1|Outcome|Minocycline|"Open label treatment using minocycline.~Minocycline: Minocycline 100 mg twice daily for 8 weeks"
174997|NCT01659320|E1|Reported Event|Minocycline|"Open label treatment using minocycline.~Minocycline: Minocycline 100 mg twice daily for 8 weeks"
174998|NCT01659268|B3|Baseline|Total|Total of all reporting groups
175568|NCT01656850|B2|Baseline|NCEP Diet First, Then Almond Diet|"follow NCEP step 2 diet~NCEP Step 2 diet: follow NCEP step 2 diet"
174999|NCT01659268|B2|Baseline|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.~Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
175000|NCT01659268|B1|Baseline|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.~The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
175001|NCT01659268|P2|Participant Flow|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.~Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
175002|NCT01659268|P1|Participant Flow|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.~The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
175003|NCT01659268|O2|Outcome|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.~Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
175004|NCT01659268|O1|Outcome|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.~The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
175005|NCT01659268|O2|Outcome|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.~Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
175006|NCT01659268|O1|Outcome|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.~The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
175007|NCT01659268|O2|Outcome|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.~Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
175008|NCT01659268|O1|Outcome|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.~The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
175009|NCT01659268|O2|Outcome|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.~Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
175010|NCT01659268|O1|Outcome|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.~The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
175011|NCT01659268|E2|Reported Event|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.~Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
175012|NCT01659268|E1|Reported Event|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.~The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
175013|NCT01659125|B1|Baseline|OCFighter Participants|"OCFighter~OCFighter: OCFighter™ s an interactive, internet guided self-help (GSH) treatment program for obsessive-compulsive disorder (OCD). It uses the evidence based approach known as Cognitive Behavioral Therapy (CBT) and was adapted from the previously validated BT STEPS program for OCD. The program teaches the best practice CBT technique to help with OCD called exposure with ritual prevention (ERP)."
175014|NCT01659125|P1|Participant Flow|OCFighter Participants|"OCFighter~OCFighter: OCFighter™ s an interactive, internet guided self-help (GSH) treatment program for obsessive-compulsive disorder (OCD). It uses the evidence based approach known as Cognitive Behavioral Therapy (CBT) and was adapted from the previously validated BT STEPS program for OCD. The program teaches the best practice CBT technique to help with OCD called exposure with ritual prevention (ERP)."
175015|NCT01659125|O1|Outcome|OCFighter Participants|Participants who initiated treatment
175016|NCT01659125|O1|Outcome|OCFighter Participants|Participants who initiated treatment
175017|NCT01659125|E1|Reported Event|OCFighter Participants|"OCFighter~OCFighter: OCFighter™ s an interactive, internet guided self-help (GSH) treatment program for obsessive-compulsive disorder (OCD). It uses the evidence based approach known as Cognitive Behavioral Therapy (CBT) and was adapted from the previously validated BT STEPS program for OCD. The program teaches the best practice CBT technique to help with OCD called exposure with ritual prevention (ERP)."
175018|NCT01659021|B3|Baseline|Total|Total of all reporting groups
175019|NCT01659021|B2|Baseline|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
175020|NCT01659021|B1|Baseline|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
175021|NCT01659021|P2|Participant Flow|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
175022|NCT01659021|P1|Participant Flow|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of chronic lymphocytic leukemia (CLL), intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
175023|NCT01659021|O2|Outcome|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
175024|NCT01659021|O1|Outcome|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
175025|NCT01659021|O2|Outcome|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation~Participants in this group had 17p deletion and/or TP53 mutation."
175026|NCT01659021|O1|Outcome|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation~Participants in this group had 17p deletion and/or TP53 mutation."
175027|NCT01659021|O2|Outcome|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
175028|NCT01659021|O1|Outcome|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
175029|NCT01659021|O2|Outcome|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
175030|NCT01659021|O1|Outcome|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
175031|NCT01659021|O2|Outcome|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
175032|NCT01659021|O1|Outcome|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
175077|NCT01658839|O1|Outcome|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
179085|NCT01644240|P2|Participant Flow|Placebo|Placebo - saline: Intravenous infusion
175033|NCT01659021|O2|Outcome|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
175034|NCT01659021|O1|Outcome|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
175035|NCT01659021|E2|Reported Event|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
175036|NCT01659021|E1|Reported Event|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
175037|NCT01658943|B3|Baseline|Total|Total of all reporting groups
175038|NCT01658943|B2|Baseline|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
175039|NCT01658943|B1|Baseline|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
175040|NCT01658943|P2|Participant Flow|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
175041|NCT01658943|P1|Participant Flow|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
175042|NCT01658943|O2|Outcome|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
175043|NCT01658943|O1|Outcome|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
175044|NCT01658943|O2|Outcome|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
175045|NCT01658943|O1|Outcome|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
175046|NCT01658943|O2|Outcome|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
175047|NCT01658943|O1|Outcome|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
175048|NCT01658943|O2|Outcome|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
175049|NCT01658943|O1|Outcome|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
175050|NCT01658943|E2|Reported Event|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
175051|NCT01658943|E1|Reported Event|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
175052|NCT01658904|B4|Baseline|Total|Total of all reporting groups
175053|NCT01658904|B3|Baseline|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
175078|NCT01658839|O1|Outcome|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
175079|NCT01658839|O1|Outcome|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
175638|NCT01656850|O2|Outcome|NCEP Step 2 Diet|"follow NCEP step 2 diet~NCEP Step 2 diet: follow NCEP step 2 diet"
175054|NCT01658904|B2|Baseline|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
175055|NCT01658904|B1|Baseline|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
175056|NCT01658904|P3|Participant Flow|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
175057|NCT01658904|P2|Participant Flow|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
175058|NCT01658904|P1|Participant Flow|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
175059|NCT01658904|O3|Outcome|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
175060|NCT01658904|O2|Outcome|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
175061|NCT01658904|O1|Outcome|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
175062|NCT01658904|O3|Outcome|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70.~Carfilzomib~Melphalan~Filgrastim"
175063|NCT01658904|O2|Outcome|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70.~Carfilzomib~Melphalan~Filgrastim"
175080|NCT01658839|O1|Outcome|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
175081|NCT01658839|O1|Outcome|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
175773|NCT01656408|O2|Outcome|Panel E – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
175064|NCT01658904|O1|Outcome|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70.~Carfilzomib~Melphalan~Filgrastim"
175065|NCT01658904|O3|Outcome|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
175066|NCT01658904|O2|Outcome|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
175067|NCT01658904|O1|Outcome|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
175068|NCT01658904|O3|Outcome|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
175069|NCT01658904|O2|Outcome|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
175070|NCT01658904|O1|Outcome|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
175071|NCT01658904|E3|Reported Event|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
175072|NCT01658904|E2|Reported Event|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
175073|NCT01658904|E1|Reported Event|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
175074|NCT01658839|B1|Baseline|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
175075|NCT01658839|P1|Participant Flow|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
175774|NCT01656408|O1|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
175082|NCT01658839|E1|Reported Event|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
175083|NCT01658813|B1|Baseline|Number of Participants|5-Fluorouracil and Interferon-alfa-2b
175084|NCT01658813|P1|Participant Flow|5-FU and Interferon-alfa-2b|All patients received 5-Fluorouracil and Interferon-alfa-2b
175085|NCT01658813|O1|Outcome|Median Survival|The median survival of patients treated on study was determined.
175086|NCT01658813|O1|Outcome|Median Duration of Response|The median duration of response was determined.
175087|NCT01658813|O1|Outcome|Response Rate|percentage of patients responding
175088|NCT01658813|O1|Outcome|Number of Responders|the number of patients responding
175089|NCT01658813|O1|Outcome|Progression Free Survival|5-Fluorouracil and Interferon-alfa-2b
175090|NCT01658813|E1|Reported Event|Number of Participants|5-Fluorouracil and Interferon-alfa-2b
175091|NCT01658735|B4|Baseline|Total|Total of all reporting groups
175092|NCT01658735|B3|Baseline|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
175093|NCT01658735|B2|Baseline|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
175094|NCT01658735|B1|Baseline|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
175095|NCT01658735|P3|Participant Flow|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
175096|NCT01658735|P2|Participant Flow|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
175097|NCT01658735|P1|Participant Flow|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
175098|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
175099|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
175100|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
175101|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
175102|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
175103|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
175104|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
175105|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
175106|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
175107|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
179086|NCT01644240|P1|Participant Flow|TD-8954 Dose 1|TD-8954: Intravenous infusion
175108|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
175109|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
175110|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
175111|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
175112|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
175113|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
175114|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
175115|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
175116|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
175117|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
175118|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
175119|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
175120|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
175121|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
175122|NCT01658735|E3|Reported Event|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
175123|NCT01658735|E2|Reported Event|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
175124|NCT01658735|E1|Reported Event|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
175125|NCT01658657|B3|Baseline|Total|Total of all reporting groups
175126|NCT01658657|B2|Baseline|Fixed-dose Combination Treatment-guided Therapy|"Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.~Amlodipine~metoprolol~lisinopril/hydrochlorothiazide"
175127|NCT01658657|B1|Baseline|PRA-guided Therapy|"Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.~Hydrochlorothiazide~Lisinopril~Amlodipine~metoprolol"
175775|NCT01656408|O2|Outcome|Panel E – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
175128|NCT01658657|P2|Participant Flow|Fixed-dose Combination Treatment-guided Therapy|"Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.~Amlodipine~metoprolol~lisinopril/hydrochlorothiazide"
175129|NCT01658657|P1|Participant Flow|PRA-guided Therapy|"Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.~Hydrochlorothiazide~Lisinopril~Amlodipine~metoprolol"
175130|NCT01658657|O2|Outcome|Fixed-dose Combination Treatment-guided Therapy|"Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.~Amlodipine~metoprolol~lisinopril/hydrochlorothiazide"
175131|NCT01658657|O1|Outcome|PRA-guided Therapy|"Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.~Hydrochlorothiazide~Lisinopril~Amlodipine~metoprolol"
175132|NCT01658657|E2|Reported Event|Fixed-dose Combination Treatment-guided Therapy|"Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.~Amlodipine~metoprolol~lisinopril/hydrochlorothiazide"
175133|NCT01658657|E1|Reported Event|PRA-guided Therapy|"Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.~Hydrochlorothiazide~Lisinopril~Amlodipine~metoprolol"
175134|NCT01658579|B5|Baseline|Total|Total of all reporting groups
175135|NCT01658579|B4|Baseline|Lantus Evening Then Morning|Lantus SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B.
175136|NCT01658579|B3|Baseline|Lantus Morning Then Evening|Lantus SC injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B.
175137|NCT01658579|B2|Baseline|HOE901-U300 Evening Then Morning|HOE901-U300 SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B.
175138|NCT01658579|B1|Baseline|HOE901-U300 Morning Then Evening|HOE901-U300 SC injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B.
175139|NCT01658579|P4|Participant Flow|Lantus Evening Then Morning|Lantus SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L (80–130 mg/dL).
175140|NCT01658579|P3|Participant Flow|Lantus Morning Then Evening|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L (80–130 mg/dL).
175141|NCT01658579|P2|Participant Flow|HOE901-U300 Evening Then Morning|HOE901-U300 SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L (80–130 mg/dL).
175142|NCT01658579|P1|Participant Flow|HOE901-U300 Morning Then Evening|HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 millimole per liter (mmol/L) (80–130 milligram per deciliter [mg/dL]).
175143|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
175144|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
175145|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
175146|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
175147|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
175148|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
175149|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
175150|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
175151|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
175152|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
175153|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
175154|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
175155|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
175156|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
175157|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
175158|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
175159|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
175160|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
175161|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
175162|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
175163|NCT01658579|E2|Reported Event|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
175164|NCT01658579|E1|Reported Event|HOE901-U300 Combined|HOE901­U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
175165|NCT01658514|B5|Baseline|Total|Total of all reporting groups
175166|NCT01658514|B4|Baseline|Severe RI|Severe Renal Impairment = eGFR ≥15 to <30 mL/min/1.73 m²
175167|NCT01658514|B3|Baseline|Moderate RI|Moderate Renal Impairment = eGFR ≥30 to <60 mL/min/1.73 m²
175168|NCT01658514|B2|Baseline|Mild RI|Mild Renal Impairment = eGFR ≥60 to <90 mL/min/1.73 m²
175169|NCT01658514|B1|Baseline|Normal|Normal Renal Function = eGFR ≥90 mL/min/1.73 m²
175170|NCT01658514|P3|Participant Flow|Sequence BCA|"A = 1 dose of 1000 mg Met XR B = 1 dose of 1000 mg Met DR C = 1 dose of placebo~each treatment was separated by a wash out period of 2 to 10 days"
175171|NCT01658514|P2|Participant Flow|Sequence CAB|"A = 1 dose of 1000 mg Met XR B = 1 dose of 1000 mg Met DR C = 1 dose of placebo~each treatment was separated by a wash out period of 2 to 10 days"
175172|NCT01658514|P1|Participant Flow|Sequence ABC|"A = 1 dose of 1000 mg Met XR B = 1 dose of 1000 mg Met DR C = 1 dose of placebo~each treatment was separated by a wash out period of 2 to 10 days"
175173|NCT01658514|O2|Outcome|Met XR|One dose of 1000 mg Metformin Extended-Release
175174|NCT01658514|O1|Outcome|Met DR|One dose of 1000 mg Metformin Delayed-Release
175175|NCT01658514|O2|Outcome|Met XR|One dose of 1000 mg Metformin Extended-Release
175176|NCT01658514|O1|Outcome|Met DR|One dose of 1000 mg Metformin Delayed-Release
175177|NCT01658514|O2|Outcome|Met XR|One dose of 1000 mg Metformin Extended-Release
175178|NCT01658514|O1|Outcome|Met DR|One dose of 1000 mg Metformin Delayed-Release
175179|NCT01658514|E3|Reported Event|Met XR|One dose of 1000 mg Metformin Extended-Release
175180|NCT01658514|E2|Reported Event|Met DR|One dose of 1000 mg Metformin Delayed-Release
175181|NCT01658514|E1|Reported Event|Placebo|One dose of Placebo
175182|NCT01658436|B1|Baseline|BEZ235 300 mg/400 mg Bid|Oral BEZ235 300 mg/400 mg bid was investigated in stage 1 of study
175183|NCT01658436|P2|Participant Flow|BEZ235 400 mg Bid|Oral BEZ235 400 mg bid was investigated in stage 1 of study
175184|NCT01658436|P1|Participant Flow|BEZ235 300 mg|Oral BEZ235 300 mg bid was investigated in stage 1 of study
175185|NCT01658436|O1|Outcome|BEZ235 300 mg/400 mg Bid|Oral BEZ235 300 mg/400 mg bid was investigated in stage 1 of study
175186|NCT01658436|O1|Outcome|BEZ235 300 mg/400 mg Bid|Oral BEZ235 300 mg/400 mg bid was investigated in stage 1 of study
175187|NCT01658436|O1|Outcome|BEZ235 300 mg/400 mg Bid|Oral BEZ235 300 mg/400 mg bid was investigated in stage 1 of study
175188|NCT01658436|E2|Reported Event|BEZ235 400 mg Bid|BEZ235 400 mg bid
175189|NCT01658436|E1|Reported Event|BEZ235 300 mg Bid|BEZ235 300 mg bid
175190|NCT01658228|B3|Baseline|Total|Total of all reporting groups
175191|NCT01658228|B2|Baseline|Placebo Treatment Group|"For the initial 16 weeks of open-label antidepressant treatment, citalopram up to 20 mg daily or venlafaxine up to 225 mg daily was prescribed. At 16 weeks, all patients were randomized, double-blind, to add-on donepezil or placebo for 62 weeks. Placebo dose was increased during the study to match Donepezil dose increases while continuing antidepressants.~Placebo: A placebo capsule will be given to randomized subjects for the starting at week 16 and continuing for the remainder of the study. This group will not receive donepezil as treatment."
175192|NCT01658228|B1|Baseline|Donepezil Treatment Group|"For the initial 16 weeks of open-label antidepressant treatment, citalopram up to 20 mg daily or venlafaxine up to 225 mg daily was prescribed. At 16 weeks, all patients were randomized, double-blind, to add-on donepezil or placebo for 62 weeks. Donepezil was started at 5 mg and increased to 10 mg daily or maximum tolerated dose while continuing antidepressants.~Donepezil: Donepezil 5mg will be given for 6 weeks and if tolerated, the dose will be increased to 10 mg per day. The dose range of 5 to 10 mg per day is the recommended dose for donepezil in the treatment of mild to moderate Alzheimer's disease."
175193|NCT01658228|P2|Participant Flow|Placebo Treatment Group|For the initial 16 weeks of open-label antidepressant treatment, citalopram up to 20 mg daily or venlafaxine up to 225 mg daily was prescribed. At 16 weeks, all patients were randomized, double-blind, to add-on donepezil or placebo for 62 weeks. Placebo dose was increased during the study to match Donepezil dose increases while continuing antidepressants.
175194|NCT01658228|P1|Participant Flow|Donepezil Treatment Group|For the initial 16 weeks of open-label antidepressant treatment, citalopram up to 20 mg daily or venlafaxine up to 225 mg daily was prescribed. At 16 weeks, all patients were randomized, double-blind, to add-on donepezil or placebo for 62 weeks. Donepezil was started at 5 mg and increased to 10 mg daily or maximum tolerated dose while continuing antidepressants.
175262|NCT01657877|O3|Outcome|Dentifrice Containing 0 Ppm Fluoride + 5% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 0 ppm fluoride and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
175195|NCT01658228|O2|Outcome|Placebo Treatment Group|For the initial 16 weeks of open-label antidepressant treatment, citalopram up to 20 mg daily or venlafaxine up to 225 mg daily was prescribed. At 16 weeks, all patients were randomized, double-blind, to add-on donepezil or placebo for 62 weeks. Placebo dose was increased during the study to match Donepezil dose increases while continuing antidepressants.
175196|NCT01658228|O1|Outcome|Donepezil Treatment Group|For the initial 16 weeks of open-label antidepressant treatment, citalopram up to 20 mg daily or venlafaxine up to 225 mg daily was prescribed. At 16 weeks, all patients were randomized, double-blind, to add-on donepezil or placebo for 62 weeks. Donepezil was started at 5 mg and increased to 10 mg daily or maximum tolerated dose while continuing antidepressants.
175197|NCT01658228|O2|Outcome|Placebo Treatment Group|For the initial 16 weeks of open-label antidepressant treatment, citalopram up to 20 mg daily or venlafaxine up to 225 mg daily was prescribed. At 16 weeks, all patients were randomized, double-blind, to add-on donepezil or placebo for 62 weeks. Placebo dose was increased during the study to match Donepezil dose increases while continuing antidepressants.
175198|NCT01658228|O1|Outcome|Donepezil Treatment Group|For the initial 16 weeks of open-label antidepressant treatment, citalopram up to 20 mg daily or venlafaxine up to 225 mg daily was prescribed. At 16 weeks, all patients were randomized, double-blind, to add-on donepezil or placebo for 62 weeks. Donepezil was started at 5 mg and increased to 10 mg daily or maximum tolerated dose while continuing antidepressants.
175199|NCT01658228|O2|Outcome|Placebo Treatment Group|For the initial 16 weeks of open-label antidepressant treatment, citalopram up to 20 mg daily or venlafaxine up to 225 mg daily was prescribed. At 16 weeks, all patients were randomized, double-blind, to add-on donepezil or placebo for 62 weeks. Placebo dose was increased during the study to match Donepezil dose increases while continuing antidepressants.
175200|NCT01658228|O1|Outcome|Donepezil Treatment Group|For the initial 16 weeks of open-label antidepressant treatment, citalopram up to 20 mg daily or venlafaxine up to 225 mg daily was prescribed. At 16 weeks, all patients were randomized, double-blind, to add-on donepezil or placebo for 62 weeks. Donepezil was started at 5 mg and increased to 10 mg daily or maximum tolerated dose while continuing antidepressants.
175201|NCT01658228|E2|Reported Event|Placebo Treatment Group|For the initial 16 weeks of open-label antidepressant treatment, citalopram up to 20 mg daily or venlafaxine up to 225 mg daily was prescribed. At 16 weeks, all patients were randomized, double-blind, to add-on donepezil or placebo for 62 weeks. Placebo dose was increased during the study to match Donepezil dose increases while continuing antidepressants.
175202|NCT01658228|E1|Reported Event|Donepezil Treatment Group|For the initial 16 weeks of open-label antidepressant treatment, citalopram up to 20 mg daily or venlafaxine up to 225 mg daily was prescribed. At 16 weeks, all patients were randomized, double-blind, to add-on donepezil or placebo for 62 weeks. Donepezil was started at 5 mg and increased to 10 mg daily or maximum tolerated dose while continuing antidepressants.
175203|NCT01658072|B3|Baseline|Total|Total of all reporting groups
175204|NCT01658072|B2|Baseline|Epidural Patient Controlled Analgesia (Epidural PCA)|Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway.
175205|NCT01658072|B1|Baseline|Peri-Articular Injection|Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection
175206|NCT01658072|P2|Participant Flow|Epidural Patient Controlled Analgesia (Epidural PCA)|Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway.
175207|NCT01658072|P1|Participant Flow|Peri-Articular Injection|Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection
175208|NCT01658072|O2|Outcome|Epidural Patient Controlled Analgesia (Epidural PCA)|Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway.
175209|NCT01658072|O1|Outcome|Peri-Articular Injection|Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection
175210|NCT01658072|E2|Reported Event|Epidural Patient Controlled Analgesia (Epidural PCA)|Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway.
175211|NCT01658072|E1|Reported Event|Peri-Articular Injection|Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection
175212|NCT01658020|B3|Baseline|Total|Total of all reporting groups
175213|NCT01658020|B2|Baseline|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7 days
175214|NCT01658020|B1|Baseline|DW224|Zabofloxacin 367mg tablet P.O. once daily for 3 days and then placebo P.O. once daily for 2 days
175215|NCT01658020|P2|Participant Flow|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7days
175216|NCT01658020|P1|Participant Flow|DW224|Zabofloxacin 400mg tablet P.O. once daily for 5days and Placebo P.O. once daily
175217|NCT01658020|O2|Outcome|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7 days
175218|NCT01658020|O1|Outcome|DW224|Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
175219|NCT01658020|O2|Outcome|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7 days
175220|NCT01658020|O1|Outcome|DW224|Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
175221|NCT01658020|O2|Outcome|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7 days
175222|NCT01658020|O1|Outcome|DW224|Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
175223|NCT01658020|O2|Outcome|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7 days
175224|NCT01658020|O1|Outcome|DW224|Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
175225|NCT01658020|O2|Outcome|Avelox|Moxifloxacin 400mg tablet P.O. once daily 7 days
175226|NCT01658020|O1|Outcome|DW224|Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
175227|NCT01658020|O2|Outcome|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7 days
175228|NCT01658020|O1|Outcome|DW224|Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
175229|NCT01658020|E2|Reported Event|Avelox|"Moxifloxacin Tablet 400mg given by oral administration~Zabofloxacin Tablet 400mg: multiple-dose"
175230|NCT01658020|E1|Reported Event|DW224|"Zabofloxacin Tablet 400mg given by oral administration~Moxifloxacin Tablet 400mg: multiple-dose"
175231|NCT01657903|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline parameters.
175232|NCT01657903|P1|Participant Flow|Overall|This was a 4-way crossover study. Participants brushed with 1.5 g of low relative dentine abrasivity (RDA) gel to foam toothpaste (Toothpaste 1) containing 1450 parts per million (ppm) of fluoride (F) as sodium fluoride (NaF) and 5% weight by weight (w/w) potassium nitrate (KNO3); 1.5 g of medium RDA gel to foam toothpaste (Toothpaste 2) containing 1450 ppm F as NaF and 5% w/w KNO3; 1.5 g of Marketed toothpaste (Toothpaste 3) containing 1450 ppm F as NaF and 5% w/w KNO3; and 1.5 g of placebo toothpaste containing no fluoride but 5% w/w KNO3. There was a washout period of 2 days following each treatment session. In this washout period, participants used a non-fluoridated toothpaste to ensure no carry over effect.
175233|NCT01657903|O4|Outcome|No Fluoride/KNO3 Toothpaste|Participants brushed with a fluoride free toothpaste (0 ppm F) containing only 5% w/w KNO3.
175234|NCT01657903|O3|Outcome|NaF/KNO3 Toothpaste 3|Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
175235|NCT01657903|O2|Outcome|NaF/KNO3 Toothpaste 2|Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
175236|NCT01657903|O1|Outcome|NaF/KNO3 Toothpaste 1|Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
175237|NCT01657903|O4|Outcome|No Fluoride/KNO3 Toothpaste|Participants brushed with a fluoride free toothpaste (0 ppmF) containing only 5% w/w KNO3.
175238|NCT01657903|O3|Outcome|NaF/KNO3 Toothpaste 3|Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
175239|NCT01657903|O2|Outcome|NaF/KNO3 Toothpaste 2|Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
175240|NCT01657903|O1|Outcome|NaF/KNO3 Toothpaste 1|Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
175241|NCT01657903|O4|Outcome|No Fluoride/KNO3 Toothpaste|Participants brushed with a fluoride free toothpaste (0 ppm F) containing only 5% w/w KNO3.
175242|NCT01657903|O3|Outcome|NaF/KNO3 Toothpaste 3|Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
175243|NCT01657903|O2|Outcome|NaF/KNO3 Toothpaste 2|Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
175244|NCT01657903|O1|Outcome|NaF/KNO3 Toothpaste 1|Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
175245|NCT01657903|O4|Outcome|No Fluoride/KNO3 Toothpaste|Participants brushed with a fluoride free toothpaste (0 ppmF) containing only 5% w/w KNO3.
175246|NCT01657903|O3|Outcome|NaF/KNO3 Toothpaste 3|Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
175247|NCT01657903|O2|Outcome|NaF/KNO3 Toothpaste 2|Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
175248|NCT01657903|O1|Outcome|NaF/KNO3 Toothpaste 1|Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
175249|NCT01657903|E4|Reported Event|No Fluoride/KNO3 Toothpaste|Participants brushed with a fluoride free toothpaste (0 ppmF) containing only 5% w/w KNO3.
175250|NCT01657903|E3|Reported Event|NaF/KNO3 Toothpaste 3|Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
175251|NCT01657903|E2|Reported Event|NaF/KNO3 Toothpaste 2|Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
175252|NCT01657903|E1|Reported Event|NaF/KNO3 Toothpaste 1|Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 parts per million of fluoride as NaF and 5% w/w KNO3.
175253|NCT01657877|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline characteristics.
175254|NCT01657877|P1|Participant Flow|Overall Participants|"In this cross-over study, participant partial dentures were modified to hold two enamel specimens. Denture was modified at the start of the first treatment period to hold the enamel specimens. The participants were randomized using a computer generated program to receive following dentifrices:~Dentifrice containing 1500 parts per million (ppm) as sodium monofluorophosphate (SMFP) + 5% calcium sodium phosphosilicate (CSP)~Dentifrice containing 1500 ppm fluoride as SMFP + 0% CSP~Dentifrice containing 500 ppm fluoride as SMFP + 0% CSP~Dentifrice containing 0 ppm fluoride + 0% CSP~Dentifrice containing 0 ppm fluoride + 5% CSP. The participants applied the given dentifrice as per their treatment group to a toothbrush and brushed their natural teeth twice daily for one timed minute. There was a washout period of 6 days between each treatment period."
175255|NCT01657877|O2|Outcome|Dentifrice Containing 1500ppm Fluoride as SMFP + 5 % CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
175256|NCT01657877|O1|Outcome|Dentifrice Containing 1500ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
175257|NCT01657877|O5|Outcome|Dentifrice Containing 0 Ppm Fluoride + 5% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
175258|NCT01657877|O4|Outcome|Dentifrice Containing 0 Ppm Fluoride + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and no CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
175259|NCT01657877|O3|Outcome|Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
175260|NCT01657877|O2|Outcome|Dentifrice Containing 1500 Ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
175261|NCT01657877|O1|Outcome|Dentifrice Containing 1500 Ppm Fluoride as SMFP + 5% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
175447|NCT01657305|O2|Outcome|Investigator Assessment Day 14|Efficacy as assessed by investigator at Day 14
175263|NCT01657877|O2|Outcome|Dentifrice Containing 0 Ppm Fluoride + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 0 ppm fluoride and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
175264|NCT01657877|O1|Outcome|Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
175265|NCT01657877|E5|Reported Event|Dentifrice Containing 0 Ppm Fluoride + 5% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
175266|NCT01657877|E4|Reported Event|Dentifrice Containing 0 Ppm Fluoride + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and no CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
175267|NCT01657877|E3|Reported Event|Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
175268|NCT01657877|E2|Reported Event|Dentifrice Containing 1500 Ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
175269|NCT01657877|E1|Reported Event|Dentifrice Containing 1500 Ppm Fluoride as SMFP + 5% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
175270|NCT01657799|B4|Baseline|Total|Total of all reporting groups
175271|NCT01657799|B3|Baseline|Veliparib 200 mg BID + WBRT|Participants received veliparib 200 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
175272|NCT01657799|B2|Baseline|Veliparib 50 mg BID + WBRT|Participants received veliparib 50 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
175273|NCT01657799|B1|Baseline|Placebo BID + WBRT|Participants received placebo twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
175274|NCT01657799|P3|Participant Flow|Veliparib 200 mg BID + WBRT|Participants received veliparib 200 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
175275|NCT01657799|P2|Participant Flow|Veliparib 50 mg BID + WBRT|Participants received veliparib 50 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
175276|NCT01657799|P1|Participant Flow|Placebo BID + WBRT|Participants received placebo twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
175277|NCT01657799|O3|Outcome|Veliparib 200 mg BID + WBRT|Participants received veliparib 200 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
175278|NCT01657799|O2|Outcome|Veliparib 50 mg BID + WBRT|Participants received veliparib 50 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
175279|NCT01657799|O1|Outcome|Placebo BID + WBRT|Participants received placebo twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
175280|NCT01657799|O3|Outcome|Veliparib 200 mg BID + WBRT|Participants received veliparib 200 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
175281|NCT01657799|O2|Outcome|Veliparib 50 mg BID + WBRT|Participants received veliparib 50 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
175282|NCT01657799|O1|Outcome|Placebo BID + WBRT|Participants received placebo twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
175283|NCT01657799|O3|Outcome|Veliparib 200 mg BID + WBRT|Participants received veliparib 200 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
175284|NCT01657799|O2|Outcome|Veliparib 50 mg BID + WBRT|Participants received veliparib 50 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
175285|NCT01657799|O1|Outcome|Placebo BID + WBRT|Participants received placebo twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
175286|NCT01657799|O3|Outcome|Veliparib 200 mg BID + WBRT|Participants received veliparib 200 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
175287|NCT01657799|O2|Outcome|Veliparib 50 mg BID + WBRT|Participants received veliparib 50 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
175448|NCT01657305|O1|Outcome|Investigator Asssessment Day 7|Efficacy as assessed by investigator at Day 7
179087|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
175288|NCT01657799|O1|Outcome|Placebo BID + WBRT|Participants received placebo twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
175289|NCT01657799|E3|Reported Event|Veliparib 200 mg BID + WBRT|Participants received veliparib 200 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
175290|NCT01657799|E2|Reported Event|Veliparib 50 mg BID + WBRT|Participants received veliparib 50 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
175291|NCT01657799|E1|Reported Event|Placebo BID + WBRT|Participants received placebo twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
175292|NCT01657461|B3|Baseline|Total|Total of all reporting groups
175293|NCT01657461|B2|Baseline|IV t-PA|IV infusion of tPA
175294|NCT01657461|B1|Baseline|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
175295|NCT01657461|P2|Participant Flow|IV t-PA|IV infusion of tPA
175296|NCT01657461|P1|Participant Flow|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
175297|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
175298|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
175299|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
175300|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
175301|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
175302|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
175303|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
175304|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
175305|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
175306|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
175307|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
175308|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
175309|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
175310|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
175311|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
175312|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
175313|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
175314|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
175315|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
175316|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
175317|NCT01657461|E2|Reported Event|IV t-PA|IV infusion of tPA
175318|NCT01657461|E1|Reported Event|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
175319|NCT01657370|B7|Baseline|Total|Total of all reporting groups
175320|NCT01657370|B6|Baseline|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175321|NCT01657370|B5|Baseline|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175322|NCT01657370|B4|Baseline|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175323|NCT01657370|B3|Baseline|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175324|NCT01657370|B2|Baseline|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175325|NCT01657370|B1|Baseline|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175326|NCT01657370|P6|Participant Flow|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175327|NCT01657370|P5|Participant Flow|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175328|NCT01657370|P4|Participant Flow|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175329|NCT01657370|P3|Participant Flow|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175330|NCT01657370|P2|Participant Flow|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175331|NCT01657370|P1|Participant Flow|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175332|NCT01657370|O5|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175333|NCT01657370|O4|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175334|NCT01657370|O3|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175335|NCT01657370|O2|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175336|NCT01657370|O1|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175337|NCT01657370|O5|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175338|NCT01657370|O4|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175339|NCT01657370|O3|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175340|NCT01657370|O2|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175341|NCT01657370|O1|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175342|NCT01657370|O5|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175343|NCT01657370|O4|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175344|NCT01657370|O3|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175345|NCT01657370|O2|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175346|NCT01657370|O1|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175347|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175348|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175349|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175350|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175351|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175352|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175353|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175354|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175355|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
185379|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
175356|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175357|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175358|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175359|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175360|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175361|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175362|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175363|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175364|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175365|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175366|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175367|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175368|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175369|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175370|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175371|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175372|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175373|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175374|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175375|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175376|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175377|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175378|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175379|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175380|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175381|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
185380|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
175382|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175383|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175384|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175385|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175386|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175387|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175388|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175389|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175390|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175391|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175392|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175393|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175394|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175395|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175396|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175397|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175398|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175399|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175400|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175401|NCT01657370|O5|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175402|NCT01657370|O4|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175403|NCT01657370|O3|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175404|NCT01657370|O2|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175405|NCT01657370|O1|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175406|NCT01657370|E6|Reported Event|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175407|NCT01657370|E5|Reported Event|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
185381|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
175408|NCT01657370|E4|Reported Event|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175409|NCT01657370|E3|Reported Event|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175410|NCT01657370|E2|Reported Event|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175411|NCT01657370|E1|Reported Event|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
175412|NCT01657305|B1|Baseline|Entire Study Population|Intra-individual comparison: A split-thickness skin graft (STSG) donor site wound ≥15 cm² in size was divided in 2 halves. One half was randomized to Oleogel-S10 treatment and non-adhesive wound dressing, the other half to non-adhesive wound dressing only. Non-adhesive wound dressings, specifically soft silicone faced polyurethane foam dressings (e.g., Mepilex®), represent standard of care (SOC) in the treatment of STSG donor site wounds. Oleogel-S10 was administered at a thickness of 1 mm (0.04 inches) and wound dressings were changed at least every 3 to 4 days. Study treatment continued until both wound halves were closed (at least 95% epithelialised) or ended at Day 28.
175413|NCT01657305|P1|Participant Flow|Entire Study Population|Intraindividual comparison: A split-thickness skin graft (STSG) donor site wound ≥15 cm² in size was divided in 2 halves. One wound half was randomized to Oleogel-S10 treatment and non-adhesive wound dressing, the other half to non-adhesive wound dressing (intra-individual comparison). Non-adhesive wound dressings such as soft silicone-faced polyurethane foam dressings (e.g., Mepilex®) represent standard of care (SOC) in the treatment of STSG donor site wounds. Oleogel-S10 was administered at a thickness of approximately 1 mm or 0.04 inches. Treatment was repeated and wound dressings were changed at least every 3 to 4 days until wound closure (at least 95% epithelialisation) was achieved or the end of treatment was reached at Day 28.
175414|NCT01657305|O1|Outcome|Entire Study Population|All participants who were randomized and treated with Oleogel-S10 and non-adhesive wound dressing and/or non-adhesive wound dressing only.
175415|NCT01657305|O1|Outcome|Entire Study Population|All participants who were randomized and treated with Oleogel-S10 and non-adhesive wound dressing and/or non-adhesive wound dressing only.
175416|NCT01657305|O1|Outcome|Entire Study Population|All participants who were randomized and treated with Oleogel-S10 and non-adhesive wound dressing and/or non-adhesive wound dressing only.
175417|NCT01657305|O2|Outcome|Treatment Period|Plasma samples collected at Day 7, Day 14, Day 21 or at end of treatment (day of wound closure or Day 28)
175418|NCT01657305|O1|Outcome|Day 0 (Pre-dose)|Plasma samples collected at the day of STSG surgery prior to first treatment with study medication
175419|NCT01657305|O2|Outcome|Treatment Period|Plasma samples collected at Day 7, Day 14, Day 21 or at end of treatment (day of wound closure or Day 28)
175420|NCT01657305|O1|Outcome|Day 0 (Pre-dose)|Plasma samples collected at the day of STSG surgery prior to first treatment with study medication
175421|NCT01657305|O10|Outcome|Participant Assessment EoT|Tolerability as assessed by participant at EoT
175422|NCT01657305|O9|Outcome|Participant Assessment Day 28|Tolerability as assessed by participant at Day 28
175423|NCT01657305|O8|Outcome|Participant Assessment Day 21|Tolerability as assessed by participant at Day 21
175424|NCT01657305|O7|Outcome|Participant Assessment Day 14|Tolerability as assessed by participant at Day 14
175425|NCT01657305|O6|Outcome|Participant Assessment Day 7|Tolerability as assessed by participant at Day 7
175426|NCT01657305|O5|Outcome|Investigator Assessment End of Treatment|Tolerability as assessed by investigator at End of Treatment (EoT)
175427|NCT01657305|O4|Outcome|Investigator Assessment Day 28|Tolerability as assessed by investigator at Day 28
175428|NCT01657305|O3|Outcome|Investigator Assessment Day 21|Tolerability as assessed by investigator at Day 21
175429|NCT01657305|O2|Outcome|Investigator Assessment Day 14|Tolerability as assessed by investigator at Day 14
175430|NCT01657305|O1|Outcome|Investigator Asssessment Day 7|Tolerability as assessed by investigator at Day 7
175431|NCT01657305|O8|Outcome|Redness at 12 Months Follow-up|Evaluation of cosmetic outcome with regard to redness at 12 months follow-up
175432|NCT01657305|O7|Outcome|Pigmentation at 12 Months Follow-up|Evaluation of cosmetic outcome with regard to pigmentation at 12 months follow-up
175433|NCT01657305|O6|Outcome|Hair Growth at 12 Months Follow-up|Evaluation of cosmetic outcome with regard to hair growth at 12 months follow-up
175434|NCT01657305|O5|Outcome|Texture at 12 Months Follow-up|Evaluation of cosmetic outcome with regard to texture at 12 months follow-up
175435|NCT01657305|O4|Outcome|Redness at 3 Months Follow-up|Evaluation of cosmetic outcome with regard to redness at 3 months follow-up
175436|NCT01657305|O3|Outcome|Pigmentation at 3 Months Follow-up|Evaluation of cosmetic outcome with regard to pigmentation at 3 months follow-up
175437|NCT01657305|O2|Outcome|Hair Growth at 3 Months Follow-up|Evaluation of cosmetic outcome with regard to hair growth at 3 months follow-up
175438|NCT01657305|O1|Outcome|Texture at 3 Months Follow-up|Evaluation of cosmetic outcome with regard to texture at 3 months follow-up
175439|NCT01657305|O10|Outcome|Participant Assessment EoT|Efficacy as assessed by participant at EoT
175440|NCT01657305|O9|Outcome|Participant Assessment Day 28|Efficacy as assessed by participant at Day 28
175441|NCT01657305|O8|Outcome|Participant Assessment Day 21|Efficacy as assessed by participant at Day 21
175442|NCT01657305|O7|Outcome|Participant Assessment Day 14|Efficacy as assessed by participant at Day 14
175443|NCT01657305|O6|Outcome|Participant Assessment Day 7|Efficacy as assessed by participant at Day 7
175444|NCT01657305|O5|Outcome|Investigator Assessment End of Treatment|Efficacy as assessed by investigator at End of Treatment (EoT)
175445|NCT01657305|O4|Outcome|Investigator Assessment Day 28|Efficacy as assessed by investigator at Day 28
175446|NCT01657305|O3|Outcome|Investigator Assessment Day 21|Efficacy as assessed by investigator at Day 21
175449|NCT01657305|O2|Outcome|Non-adhesive Wound Dressing Only|"A STSG donor site wound >15cm2 in size was divided in 2 halves. One half was randomized to treatment with non-adhesive wound dressing only (intra-individual comparison). Non-adhesive wound Dressings are Standard of care (SOC) in the Treatment of STSG donor sites. Wound Dressings were changed every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28.~Non-adhesive wound dressing only: Soft silicone faced polyurethane foam dressing such as Mepilex® only every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28."
175450|NCT01657305|O1|Outcome|Oleogel-S10, Non-adhesive Wound Dressing|"A split-thickness skin graft (STSG) donor site wound >15cm2 in size was divided in 2 halves. One half was randomized to Oleogel-S10 treatment and non-adhesive wound dressing (intra-individual comparison). Oleogel-S10 was administered (1 cm or 100 mg per cm2 wound area corresponding to thickness of about 1 mm or 0.04 inches) every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28.~Oleogel-S10, non-adhesive wound dressing: 1 cm or 100 mg Oleogel-S10 per cm2 wound area (corresponds to thickness of approximately 1 mm or 0.04 inches) every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28."
175451|NCT01657305|O2|Outcome|Non-adhesive Wound Dressing Only|"A STSG donor site wound >15cm2 in size was divided in 2 halves. One half was randomized to treatment with non-adhesive wound dressing only (intra-individual comparison). Non-adhesive wound Dressings are Standard of care (SOC) in the Treatment of STSG donor sites. Wound Dressings were changed every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28.~Non-adhesive wound dressing only: Soft silicone faced polyurethane foam dressing such as Mepilex® only every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28."
175452|NCT01657305|O1|Outcome|Oleogel-S10, Non-adhesive Wound Dressing|"A split-thickness skin graft (STSG) donor site wound >15cm2 in size was divided in 2 halves. One half was randomized to Oleogel-S10 treatment and non-adhesive wound dressing (intra-individual comparison). Oleogel-S10 was administered (1 cm or 100 mg per cm2 wound area corresponding to thickness of about 1 mm or 0.04 inches) every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28.~Oleogel-S10, non-adhesive wound dressing: 1 cm or 100 mg Oleogel-S10 per cm2 wound area (corresponds to thickness of approximately 1 mm or 0.04 inches) every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28."
175453|NCT01657305|O2|Outcome|Non-adhesive Wound Dressing Only|"A STSG donor site wound >15cm2 in size was divided in 2 halves. One half was randomized to treatment with non-adhesive wound dressing only (intra-individual comparison). Non-adhesive wound Dressings are Standard of care (SOC) in the Treatment of STSG donor sites. Wound Dressings were changed every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28.~Non-adhesive wound dressing only: Soft silicone faced polyurethane foam dressing such as Mepilex® only every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28."
175454|NCT01657305|O1|Outcome|Oleogel-S10, Non-adhesive Wound Dressing|"A split-thickness skin graft (STSG) donor site wound >15cm2 in size was divided in 2 halves. One half was randomized to Oleogel-S10 treatment and non-adhesive wound dressing (intra-individual comparison). Oleogel-S10 was administered (1 cm or 100 mg per cm2 wound area corresponding to thickness of about 1 mm or 0.04 inches) every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28.~Oleogel-S10, non-adhesive wound dressing: 1 cm or 100 mg Oleogel-S10 per cm2 wound area (corresponds to thickness of approximately 1 mm or 0.04 inches) every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28."
175455|NCT01657305|O2|Outcome|Non-adhesive Wound Dressing Only|"A STSG donor site wound >15cm2 in size was divided in 2 halves. One half was randomized to treatment with non-adhesive wound dressing only (intra-individual comparison). Non-adhesive wound Dressings are Standard of care (SOC) in the Treatment of STSG donor sites. Wound Dressings were changed every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28.~Non-adhesive wound dressing only: Soft silicone faced polyurethane foam dressing such as Mepilex® only every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28."
175456|NCT01657305|O1|Outcome|Oleogel-S10, Non-adhesive Wound Dressing|"A split-thickness skin graft (STSG) donor site wound >15cm2 in size was divided in 2 halves. One half was randomized to Oleogel-S10 treatment and non-adhesive wound dressing (intra-individual comparison). Oleogel-S10 was administered (1 cm or 100 mg per cm2 wound area corresponding to thickness of about 1 mm or 0.04 inches) every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28.~Oleogel-S10, non-adhesive wound dressing: 1 cm or 100 mg Oleogel-S10 per cm2 wound area (corresponds to thickness of approximately 1 mm or 0.04 inches) every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28."
175457|NCT01657305|O1|Outcome|Entire Study Population|All patients treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only.
175458|NCT01657305|E4|Reported Event|Localized AE Both Wound Halves|All participants treated with Oleogel-S10 plus non-adhesive wound dressing and/or non-adhesive wound dressing only. Application site reactions as judged by the investigator which occurred at both the Oleogel-S10 wound half and the non-adhesive wound dressing only half in one patient are reported in this arm.
175459|NCT01657305|E3|Reported Event|Non-adhesive Wound Wound Dressing Localized AE|All participants treated with Oleogel-S10 plus non-adhesive wound dressing and/or non-adhesive wound dressing only. Application site reactions as judged by the investigator which occurred only at the wound half treated only with non-adhesive wound dressing are reported in this arm.
175460|NCT01657305|E2|Reported Event|Oleogel-S10 Localized AE|All participants treated with Oleogel-S10 plus non-adhesive wound dressing and/or non-adhesive wound dressing only. Application site reactions as judged by the investigator which occurred only at the Oleogel-S10 wound half are reported in this arm.
175461|NCT01657305|E1|Reported Event|Entire Study Population - Systemic Adverse Events (AE)|All participants treated with Oleogel-S10 plus non-adhesive wound dressing and/or non-adhesive wound dressing only. AEs not localized to any wound application site by the investigator are reported in this arm.
175462|NCT01657292|B1|Baseline|Entire Study Population|All patients treated with Oleogel-S10 and Octenilin® wound gel.
175463|NCT01657292|P1|Participant Flow|Entire Study Population|All patients treated with Oleogel-S10 and Octenilin® wound gel.
175464|NCT01657292|O1|Outcome|Entire Study Population|All patients treated with Oleogel-S10 and Octenilin® wound gel.
175539|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
175465|NCT01657292|E4|Reported Event|Localized AE Both Wound Halves|All patients treated with Oleogel-S10 and Octenilin® wound gel. Application site reactions which occurred at both the Octenilin® wound half and Oleogel-S10 wound half in one patient are reported under this arm.
175466|NCT01657292|E3|Reported Event|Octenilin Localized AE|All patients treated with Oleogel-S10 and Octenilin® wound gel. Application site reactions which occurred only at the Octenilin® wound half are reported under this arm.
175467|NCT01657292|E2|Reported Event|Oleogel-S10 Localized AE|All patients treated with Oleogel-S10 and Octenilin® wound gel. Application site reactions which occurred only at the Oleogel-S10 wound half are reported under this arm.
175468|NCT01657292|E1|Reported Event|Entire Study Population - Systemic AEs|All patients treated with Oleogel-S10 and Octenilin® wound gel. Systemic AEs which are not localized to the wound application site are reported under this arm.
175469|NCT01657253|B3|Baseline|Total|Total of all reporting groups
175470|NCT01657253|B2|Baseline|Systane®|"Systane containing: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar~doses: 1 drop in each eye, quarter in day~Systane: Instill 1 drop in each eye four times a day, for 60 days"
175471|NCT01657253|B1|Baseline|PRO-148|"PRO-148 containing: xanthan gum and sulphate chondroitin, ophthalmic solution~doses: 1 drop in each eye, quarter in day~PRO-148: Instill 1 drop in each eye four times a day, for 60 days"
175472|NCT01657253|P2|Participant Flow|Systane®|"Systane containing: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar~doses: 1 drop in each eye, quarter in day~Systane: Instill 1 drop in each eye four times a day, for 60 days"
175473|NCT01657253|P1|Participant Flow|PRO-148|"PRO-148 containing: xanthan gum and sulphate chondroitin, ophthalmic solution~doses: 1 drop in each eye, quarter in day~PRO-148: Instill 1 drop in each eye four times a day, for 60 days"
175474|NCT01657253|O2|Outcome|Systane®|"Systane containing: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar~doses: 1 drop in each eye, quarter in day~Systane: Instill 1 drop in each eye four times a day, for 60 days"
175475|NCT01657253|O1|Outcome|PRO-148|"PRO-148 containing: xanthan gum and sulphate chondroitin, ophthalmic solution~doses: 1 drop in each eye, quarter in day~PRO-148: Instill 1 drop in each eye four times a day, for 60 days"
175476|NCT01657253|O2|Outcome|Systane®|"Systane containing: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar~doses: 1 drop in each eye, quarter in day~Systane: Instill 1 drop in each eye four times a day, for 60 days"
175477|NCT01657253|O1|Outcome|PRO-148|"PRO-148 containing: xanthan gum and sulphate chondroitin, ophthalmic solution~doses: 1 drop in each eye, quarter in day~PRO-148: Instill 1 drop in each eye four times a day, for 60 days"
175478|NCT01657253|O2|Outcome|Systane®|"Systane containing: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar~doses: 1 drop in each eye, quarter in day~Systane: Instill 1 drop in each eye four times a day, for 60 days"
175479|NCT01657253|O1|Outcome|PRO-148|"PRO-148 containing: xanthan gum and sulphate chondroitin, ophthalmic solution~doses: 1 drop in each eye, quarter in day~PRO-148: Instill 1 drop in each eye four times a day, for 60 days"
175480|NCT01657253|E2|Reported Event|Systane®|"Systane containing: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar~doses: 1 drop in each eye, quarter in day~Systane: Instill 1 drop in each eye four times a day, for 60 days"
175481|NCT01657253|E1|Reported Event|PRO-148|"PRO-148 containing: xanthan gum and sulphate chondroitin, ophthalmic solution~doses: 1 drop in each eye, quarter in day~PRO-148: Instill 1 drop in each eye four times a day, for 60 days"
175482|NCT01657032|B3|Baseline|Total|Total of all reporting groups
175483|NCT01657032|B2|Baseline|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175484|NCT01657032|B1|Baseline|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175485|NCT01657032|P2|Participant Flow|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175486|NCT01657032|P1|Participant Flow|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175487|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175488|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175489|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175490|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175491|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175492|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175493|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175494|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175495|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175496|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175497|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175498|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175499|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175500|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175501|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175540|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
185382|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
175502|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175503|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175504|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175505|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175506|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175507|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175508|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175509|NCT01657032|E2|Reported Event|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175510|NCT01657032|E1|Reported Event|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
175511|NCT01657019|B1|Baseline|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
175512|NCT01657019|P1|Participant Flow|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
175513|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
175514|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
175515|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
175541|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
179088|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
175516|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
175517|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
175518|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
175519|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
175520|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
175521|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
175522|NCT01657019|E1|Reported Event|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
175523|NCT01656967|B3|Baseline|Total|Total of all reporting groups
175524|NCT01656967|B2|Baseline|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
175525|NCT01656967|B1|Baseline|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
175526|NCT01656967|P2|Participant Flow|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
175527|NCT01656967|P1|Participant Flow|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
175528|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
175529|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
175530|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use~first-attempt success rate for SGA placement for the ILMA group (30/33, 90.9%, P = 1.0)"
175531|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera~first-attempt success rate for SGA placement for the Aura-i group (30/33, 90.9%)"
175532|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use~first-attempt success rate for SGA placement for the ILMA group (30/33, 90.9%, P = 1.0)"
175533|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera~first-attempt success rate for SGA placement for the Aura-i group (30/33, 90.9%)"
175534|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
175535|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
175536|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
175537|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
175538|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
175567|NCT01656850|B3|Baseline|Total|Total of all reporting groups
175542|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
175543|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
175544|NCT01656967|E2|Reported Event|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
175545|NCT01656967|E1|Reported Event|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
175546|NCT01656889|B3|Baseline|Total|Total of all reporting groups
175547|NCT01656889|B2|Baseline|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
175548|NCT01656889|B1|Baseline|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
175549|NCT01656889|P2|Participant Flow|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
175550|NCT01656889|P1|Participant Flow|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
175551|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
175552|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
175553|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
175554|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
175555|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
175556|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
175557|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
175558|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
175559|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
175560|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
175561|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
175562|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
175563|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
175564|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
175565|NCT01656889|E2|Reported Event|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
175566|NCT01656889|E1|Reported Event|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
175569|NCT01656850|B1|Baseline|Almond Diet First, Then NCEP Diet|"whole almonds to replace 20% daily calorie intake~whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake."
175570|NCT01656850|P2|Participant Flow|NCEP Diet First, Then Whole Almonds Diet|run in 2 weeks, NCEP diet Intervention (3 months), Washout (2 weeks), whole almonds Intervention (3 months)
175571|NCT01656850|P1|Participant Flow|Whole Almonds First, Then NCEP Diet|run in 2 weeks, whole almonds diet Intervention (3 months), Washout (2 weeks), and then NCEP diet Intervention (3 months)
175572|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
175573|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
175574|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
175575|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
175576|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
175577|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
175578|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
175579|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
175580|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
175581|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
175582|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
175583|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
175584|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
175585|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
175586|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
175587|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
175588|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
175589|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
175590|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
175591|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
175592|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
175593|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
175594|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
175595|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
175596|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
175597|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
175598|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
175599|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
175600|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
175601|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
175602|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
175603|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
175604|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
175605|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
175606|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
175607|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
175608|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
175609|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
175610|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
175611|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
175612|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
175613|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
175614|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
175615|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
175616|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
175617|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
175618|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
175619|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
175620|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
175621|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
175622|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
175623|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
175624|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
175625|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
175626|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
175627|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
175628|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
175629|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
175630|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
175631|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
175632|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
175633|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
175634|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
175635|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
175636|NCT01656850|O2|Outcome|NCEP Step 2 Diet|"follow NCEP step 2 diet~NCEP Step 2 diet: follow NCEP step 2 diet"
175637|NCT01656850|O1|Outcome|Whole Almonds|"whole almonds to replace 20% daily calorie intake~whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake."
175639|NCT01656850|O1|Outcome|Whole Almonds|"whole almonds to replace 20% daily calorie intake~whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake."
175640|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
175641|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
175642|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
175643|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
175644|NCT01656850|O2|Outcome|NCEP Step 2 Diet|"follow NCEP step 2 diet~NCEP Step 2 diet: follow NCEP step 2 diet"
175645|NCT01656850|O1|Outcome|Whole Almonds|"whole almonds to replace 20% daily calorie intake~whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake."
175646|NCT01656850|E2|Reported Event|NCEP Diet|participants received NCEP diet for 3 months
175647|NCT01656850|E1|Reported Event|Whole Almond Diet|participants received experiment diet containing 20% calorie from whole almond
175648|NCT01656772|B3|Baseline|Total|Total of all reporting groups
175649|NCT01656772|B2|Baseline|Vdrive Lasso Navigation|"Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter~Vdrive Lasso navigation: Remote robotic Lasso navigation"
175650|NCT01656772|B1|Baseline|Manual Lasso Navigation|"Use of conventional manual navigation techniques with the Lasso catheter~Manual Lasso navigation: Manually maneuver a Lasso catheter"
175651|NCT01656772|P2|Participant Flow|Vdrive Lasso Navigation|"Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter~Vdrive Lasso navigation: Remote robotic Lasso navigation"
175652|NCT01656772|P1|Participant Flow|Manual Lasso Navigation|"Use of conventional manual navigation techniques with the Lasso catheter~Manual Lasso navigation: Manually maneuver a Lasso catheter"
175653|NCT01656772|O2|Outcome|Vdrive Lasso Navigation|"Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter~Vdrive Lasso navigation: Remote robotic Lasso navigation"
175654|NCT01656772|O1|Outcome|Manual Lasso Navigation|"Use of conventional manual navigation techniques with the Lasso catheter~Manual Lasso navigation: Manually maneuver a Lasso catheter"
175655|NCT01656772|O2|Outcome|Vdrive Lasso Navigation|"Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter~Vdrive Lasso navigation: Remote robotic Lasso navigation"
175656|NCT01656772|O1|Outcome|Manual Lasso Navigation|"Use of conventional manual navigation techniques with the Lasso catheter~Manual Lasso navigation: Manually maneuver a Lasso catheter"
175657|NCT01656772|E2|Reported Event|Vdrive Lasso Navigation|"Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter~Vdrive Lasso navigation: Remote robotic Lasso navigation"
175658|NCT01656772|E1|Reported Event|Manual Lasso Navigation|"Use of conventional manual navigation techniques with the Lasso catheter~Manual Lasso navigation: Manually maneuver a Lasso catheter"
175659|NCT01656759|B3|Baseline|Total|Total of all reporting groups
175660|NCT01656759|B2|Baseline|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.~Patients will be randomized to receive spray or not and postop parameters measured.~Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
175661|NCT01656759|B1|Baseline|Control Group|Control group. Will not receive the fibrin spray.
175662|NCT01656759|P2|Participant Flow|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.~Patients will be randomized to receive spray or not and postop parameters measured.~Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
175663|NCT01656759|P1|Participant Flow|Control Group|Control group. Will not receive the fibrin spray.
175664|NCT01656759|O2|Outcome|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.~Patients will be randomized to receive spray or not and postop parameters measured.~Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
175665|NCT01656759|O1|Outcome|Control Group|Control group. Will not receive the fibrin spray.
175666|NCT01656759|O2|Outcome|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.~Patients will be randomized to receive spray or not and postop parameters measured.~Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
175667|NCT01656759|O1|Outcome|Control Group|Control group. Will not receive the fibrin spray.
175668|NCT01656759|O2|Outcome|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.~Patients will be randomized to receive spray or not and postop parameters measured.~Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
175669|NCT01656759|O1|Outcome|Control Group|Control group. Will not receive the fibrin spray.
175670|NCT01656759|O2|Outcome|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.~Patients will be randomized to receive spray or not and postop parameters measured.~Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
175671|NCT01656759|O1|Outcome|Control Group|Control group. Will not receive the fibrin spray.
175672|NCT01656759|E2|Reported Event|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.~Patients will be randomized to receive spray or not and postop parameters measured.~Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
175673|NCT01656759|E1|Reported Event|Control Group|Control group. Will not receive the fibrin spray.
175674|NCT01656486|B1|Baseline|Stereotactic Radiation|"Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery.~Stereotactic Radiation: Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery that could produce a fibrosis of the pancreas and a decrease in the production of exocrine portion of the gland."
175675|NCT01656486|P1|Participant Flow|Stereotactic Radiation|"Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery.~Stereotactic Radiation: Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery that could produce a fibrosis of the pancreas and a decrease in the production of exocrine portion of the gland."
175676|NCT01656486|O1|Outcome|Stereotactic Radiation|"Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery.~Stereotactic Radiation: Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery that could produce a fibrosis of the pancreas and a decrease in the production of exocrine portion of the gland."
175677|NCT01656486|E1|Reported Event|Stereotactic Radiation|"Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery.~Stereotactic Radiation: Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery that could produce a fibrosis of the pancreas and a decrease in the production of exocrine portion of the gland."
175678|NCT01656460|B1|Baseline|Stereotactic Radiation|stereotactic
175679|NCT01656460|P4|Participant Flow|Stereotactic Radiation Dose Level 4|Radiation: Stereotactic radiation Arm 4 Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
175680|NCT01656460|P3|Participant Flow|Stereotactic Radiation Dose Level 3|Radiation: Stereotactic radiation Arm 3 Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
175681|NCT01656460|P2|Participant Flow|Stereotactic Radiation Dose Level 2|Radiation: Stereotactic radiation Arm 2 Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
175682|NCT01656460|P1|Participant Flow|Stereotactic Radiation Dose Level 1|"Radiation: Stereotactic radiation Arm 1 Dose Levels Dose per Fraction Total Dose~1 8 Gy 16 Gy"
175683|NCT01656460|O4|Outcome|Arm 4-Stereotactic Radiation Dose Level 4|Radiation: Stereotactic radiation Arm 4 Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
175684|NCT01656460|O3|Outcome|Arm 3-Stereotactic Radiation Dose Level 3|Radiation: Stereotactic radiation Arm 3 Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
175685|NCT01656460|O2|Outcome|Arm 2-Stereotactic Radiation Dose Level 2|Radiation: Stereotactic radiation Arm 2 Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
175686|NCT01656460|O1|Outcome|Arm 1-Stereotactic Radiation Dose Level 1|"Radiation: Stereotactic radiation Arm 1 Dose Levels Dose per Fraction Total Dose~1 8 Gy 16 Gy"
175687|NCT01656460|E4|Reported Event|Arm 4-Stereotactic Radiation Dose Level 4|Radiation: Stereotactic radiation Arm 4 Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
175688|NCT01656460|E3|Reported Event|Arm 3-Stereotactic Radiation Dose Level 3|Radiation: Stereotactic radiation Arm 3 Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
175689|NCT01656460|E2|Reported Event|Arm 2-Stereotactic Radiation Dose Level 2|Radiation: Stereotactic radiation Arm 2 Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
175690|NCT01656460|E1|Reported Event|Arm 1-Stereotactic Radiation Dose Level 1|"Radiation: Stereotactic radiation Arm 1 Dose Levels Dose per Fraction Total Dose~1 8 Gy 16 Gy"
175691|NCT01656434|B3|Baseline|Total|Total of all reporting groups
175692|NCT01656434|B2|Baseline|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
175693|NCT01656434|B1|Baseline|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
175694|NCT01656434|P2|Participant Flow|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
175695|NCT01656434|P1|Participant Flow|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
175696|NCT01656434|O2|Outcome|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
175697|NCT01656434|O1|Outcome|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
175698|NCT01656434|O2|Outcome|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
175699|NCT01656434|O1|Outcome|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
175700|NCT01656434|O2|Outcome|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
175701|NCT01656434|O1|Outcome|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
175702|NCT01656434|O2|Outcome|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
175703|NCT01656434|O1|Outcome|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
175776|NCT01656408|O1|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
179089|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
175704|NCT01656434|O2|Outcome|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
175705|NCT01656434|O1|Outcome|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
175706|NCT01656434|O2|Outcome|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
175707|NCT01656434|O1|Outcome|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
175708|NCT01656434|E2|Reported Event|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
175709|NCT01656434|E1|Reported Event|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
175710|NCT01656408|B11|Baseline|Total|Total of all reporting groups
175711|NCT01656408|B10|Baseline|Panel J – Participants With Mild to Moderate Hypertension|12 participants were randomly assigned to receive MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
175712|NCT01656408|B9|Baseline|Panel I – Participants With Mild to Moderate Hypertension|12 participants were randomly assigned to receive MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
175713|NCT01656408|B8|Baseline|Panel H – Participants With Resistant Hypertension|In Panel with crossover design, 4 participants were randomly assigned to receive active drug (MK-8150) in Period 1 and placebo in Period 2 and 4 participants were randomly assigned to receive placebo in Period 1 and active drug in Period 2. Active drug regimen was MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10); placebo regimen was placebo once daily on Days 1-10
175714|NCT01656408|B7|Baseline|Panel G – Healthy Participants|8 participants were randomly assigned to receive MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28); 2 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
175715|NCT01656408|B6|Baseline|Panel F – Elderly Participants With Mild/Moderate Hypertension|6 participants were randomly assigned to receive a single dose of MK-8150 6 mg on Day 1 and to also receive MK-8150 4 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15
175716|NCT01656408|B5|Baseline|Panel E – Elderly Participants With Mild/Moderate Hypertension|6 participants were randomly assigned to receive a single dose of MK-8150 3 mg on Day 1 and to also receive MK-8150 2 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15
175717|NCT01656408|B4|Baseline|Panel D – Participants With Mild to Moderate Hypertension|5 participants were randomly assigned to receive MK-8150 15 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
175718|NCT01656408|B3|Baseline|Panel C – Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 20 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
175719|NCT01656408|B2|Baseline|Panel B – Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 10 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
175720|NCT01656408|B1|Baseline|Panel A – Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 5 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
175721|NCT01656408|P10|Participant Flow|Panel J – Participants With Mild to Moderate Hypertension|12 participants were randomly assigned to receive MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
175722|NCT01656408|P9|Participant Flow|Panel I – Participants With Mild to Moderate Hypertension|12 participants were randomly assigned to receive MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
175723|NCT01656408|P8|Participant Flow|Panel H – Participants With Resistant Hypertension|In Panel with crossover design, 4 participants were randomly assigned to receive active drug (MK-8150) in Period 1 and placebo in Period 2 and 4 participants were randomly assigned to receive placebo in Period 1 and active drug in Period 2. Active drug regimen was MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10); placebo regimen was placebo once daily on Days 1-10
175724|NCT01656408|P7|Participant Flow|Panel G – Healthy Participants|8 participants were randomly assigned to receive MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28); 2 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
175777|NCT01656408|O2|Outcome|Panel E – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
175778|NCT01656408|O1|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
175725|NCT01656408|P6|Participant Flow|Panel F – Elderly Participants With Mild/Moderate Hypertension|6 participants were randomly assigned to receive a single dose of MK-8150 6 mg on Day 1 and to also receive MK-8150 4 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15
175726|NCT01656408|P5|Participant Flow|Panel E – Elderly Participants With Mild/Moderate Hypertension|6 participants were randomly assigned to receive a single dose of MK-8150 3 mg on Day 1 and to also receive MK-8150 2 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15
175727|NCT01656408|P4|Participant Flow|Panel D – Participants With Mild to Moderate Hypertension|5 participants were randomly assigned to receive MK-8150 15 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
175728|NCT01656408|P3|Participant Flow|Panel C – Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 20 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
175729|NCT01656408|P2|Participant Flow|Panel B – Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 10 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
175730|NCT01656408|P1|Participant Flow|Panel A – Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 5 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
175731|NCT01656408|O2|Outcome|Panel J – Placebo|Placebo once daily on Days 1-28
175732|NCT01656408|O1|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
175733|NCT01656408|O2|Outcome|Panel J – Placebo|Placebo once daily on Days 1-28
175734|NCT01656408|O1|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
175735|NCT01656408|O2|Outcome|Panel J – Placebo|Placebo once daily on Days 1-28
175736|NCT01656408|O1|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
175737|NCT01656408|O2|Outcome|Panel J – Placebo|Placebo once daily on Days 1-28
175738|NCT01656408|O1|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
175739|NCT01656408|O2|Outcome|Panel I – Placebo|Placebo once daily on Days 1-28
175740|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
175741|NCT01656408|O2|Outcome|Panel I – Placebo|Placebo once daily on Days 1-28
175742|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
175743|NCT01656408|O2|Outcome|Panel I – Placebo|Placebo once daily on Days 1-28
175744|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
175745|NCT01656408|O2|Outcome|Panel I – Placebo|Placebo once daily on Days 1-28
175746|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
175747|NCT01656408|O2|Outcome|Panel H – Placebo|Placebo once daily on Days 1-10
175748|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
175749|NCT01656408|O2|Outcome|Panel H – Placebo|Placebo once daily on Days 1-10
175750|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
175751|NCT01656408|O2|Outcome|Panel H – Placebo|Placebo once daily on Days 1-10
175752|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
175753|NCT01656408|O2|Outcome|Panel H – Placebo|Placebo once daily on Days 1-10
175754|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
175755|NCT01656408|O2|Outcome|Panel G – Placebo|Placebo once daily on Days 1-28
175756|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
175757|NCT01656408|O2|Outcome|Panel G – Placebo|Placebo once daily on Days 1-28
175758|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
175759|NCT01656408|O2|Outcome|Panel G – Placebo|Placebo once daily on Days 1-28
175760|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
175761|NCT01656408|O2|Outcome|Panel G – Placebo|Placebo once daily on Days 1-28
175762|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
175763|NCT01656408|O2|Outcome|Panel F – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
175764|NCT01656408|O1|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
175765|NCT01656408|O2|Outcome|Panel F – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
175766|NCT01656408|O1|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
175767|NCT01656408|O2|Outcome|Panel F – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
175768|NCT01656408|O1|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
175769|NCT01656408|O2|Outcome|Panel F – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
175770|NCT01656408|O1|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
175771|NCT01656408|O2|Outcome|Panel E – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
175772|NCT01656408|O1|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
175779|NCT01656408|O5|Outcome|Panel A/B/C/D – Placebo|Placebo once daily for 10 days, combining participants who received placebo in Panels A, B, C and D
175780|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
175781|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
175782|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
175783|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
175784|NCT01656408|O5|Outcome|Panel A/B/C/D – Placebo|Placebo once daily for 10 days, combining participants who received placebo in Panels A, B, C and D
175785|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
175786|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
175787|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
175788|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
175789|NCT01656408|O5|Outcome|Panel A/B/C/D – Placebo|Placebo once daily for 10 days, combining participants who received placebo in Panels A, B, C and D
175790|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
175791|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
175792|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
175793|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
175794|NCT01656408|O5|Outcome|Panel A/B/C/D – Placebo|Placebo once daily for 10 days, combining participants who received placebo in Panels A, B, C and D
175795|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
175796|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
175797|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
175798|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
175799|NCT01656408|O2|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
175800|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
175801|NCT01656408|O2|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
175802|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
175803|NCT01656408|O2|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
175804|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
175805|NCT01656408|O2|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
175806|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
175807|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
175808|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
175809|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
175810|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
175811|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
175812|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
175813|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
175814|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
175815|NCT01656408|O2|Outcome|Panel F – MK-8150 4 mg Multiple Dose Administration|Multiple dose administration of MK-8150 4 mg once daily on Days 6-15 in Panel F
175816|NCT01656408|O1|Outcome|Panel E – MK-8150 2 mg Multiple Dose Administration|Multiple dose administration of MK-8150 2 mg once daily on Days 6-15 in Panel E
175817|NCT01656408|O2|Outcome|Panel F – MK-8150 4 mg Multiple Dose Administration|Multiple dose administration of MK-8150 4 mg once daily on Days 6-15 in Panel F
175818|NCT01656408|O1|Outcome|Panel E – MK-8150 2 mg Multiple Dose Administration|Multiple dose administration of MK-8150 2 mg once daily on Days 6-15 in Panel E
175819|NCT01656408|O2|Outcome|Panel F – MK-8150 4 mg Multiple Dose Administration|Multiple dose administration of MK-8150 4 mg once daily on Days 6-15 in Panel F
175820|NCT01656408|O1|Outcome|Panel E – MK-8150 2 mg Multiple Dose Administration|Multiple dose administration of MK-8150 2 mg once daily on Days 6-15 in Panel E
175821|NCT01656408|O2|Outcome|Panel F – MK-8150 4 mg Multiple Dose Administration|Multiple dose administration of MK-8150 4 mg once daily on Days 6-15 in Panel F
175822|NCT01656408|O1|Outcome|Panel E – MK-8150 2 mg Multiple Dose Administration|Multiple dose administration of MK-8150 2 mg once daily on Days 6-15 in Panel E
175823|NCT01656408|O2|Outcome|Panel F – MK-8150 6 mg Single Dose|Single dose of MK-8150 6 mg administered on Day 1 in Panel F. No drug was administered on Days 2-5
175824|NCT01656408|O1|Outcome|Panel E – MK-8150 3 mg Single Dose|Single dose of MK-8150 3 mg administered on Day 1 in Panel E. No drug was administered on Days 2-5
175825|NCT01656408|O2|Outcome|Panel F – MK-8150 6 mg Single Dose|Single dose of MK-8150 6 mg administered on Day 1 in Panel F. No drug was administered on Days 2-5
175826|NCT01656408|O1|Outcome|Panel E – MK-8150 3 mg Single Dose|Single dose of MK-8150 3 mg administered on Day 1 in Panel E. No drug was administered on Days 2-5
175827|NCT01656408|O2|Outcome|Panel F – MK-8150 6 mg Single Dose|Single dose of MK-8150 6 mg administered on Day 1 in Panel F. No drug was administered on Days 2-5
175828|NCT01656408|O1|Outcome|Panel E – MK-8150 3 mg Single Dose|Single dose of MK-8150 3 mg administered on Day 1 in Panel E. No drug was administered on Days 2-5
175829|NCT01656408|O2|Outcome|Panel F – MK-8150 6 mg Single Dose|Single dose of MK-8150 6 mg administered on Day 1 in Panel F. No drug was administered on Days 2-5
175830|NCT01656408|O1|Outcome|Panel E – MK-8150 3 mg Single Dose|Single dose of MK-8150 3 mg administered on Day 1 in Panel E. No drug was administered on Days 2-5
175831|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
175832|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
175833|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
175834|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
175835|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
175836|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
175837|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
175838|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
175839|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
175840|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
175841|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
175842|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
175843|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
175844|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
175845|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
175846|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
175847|NCT01656408|O2|Outcome|Panel J – Placebo|Placebo once daily on Days 1-28
175848|NCT01656408|O1|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
175849|NCT01656408|O2|Outcome|Panel J – Placebo|Placebo once daily on Days 1-28
175850|NCT01656408|O1|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
175851|NCT01656408|O2|Outcome|Panel I – Placebo|Placebo once daily on Days 1-28
175852|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
175853|NCT01656408|O2|Outcome|Panel I – Placebo|Placebo once daily on Days 1-28
175854|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
175855|NCT01656408|O2|Outcome|Panel H – Placebo|Placebo once daily on Days 1-10
175856|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
175857|NCT01656408|O2|Outcome|Panel H – Placebo|Placebo once daily on Days 1-10
175858|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
175859|NCT01656408|O2|Outcome|Panel G – Placebo|Placebo once daily on Days 1-28
175860|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
175861|NCT01656408|O2|Outcome|Panel G – Placebo|Placebo once daily on Days 1-28
175862|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
175863|NCT01656408|O2|Outcome|Panel F – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
175864|NCT01656408|O1|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
175865|NCT01656408|O2|Outcome|Panel F – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
175866|NCT01656408|O1|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
175867|NCT01656408|O2|Outcome|Panel E – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
175868|NCT01656408|O1|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
175869|NCT01656408|O2|Outcome|Panel E – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
175870|NCT01656408|O1|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
175871|NCT01656408|O5|Outcome|Panel A/B/C/D – Placebo|Placebo once daily for 10 days, combining participants who received placebo in Panels A, B, C and D
175872|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
175873|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
175874|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
175875|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
175876|NCT01656408|O5|Outcome|Panel A/B/C/D – Placebo|Placebo once daily for 10 days, combining participants who received placebo in Panels A, B, C and D
175877|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
175878|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
175879|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
175880|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
175881|NCT01656408|O11|Outcome|Placebo (Panel A - J)|Combines participants who received placebo in all panels
175882|NCT01656408|O10|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
175883|NCT01656408|O9|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
175884|NCT01656408|O8|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
179090|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
175885|NCT01656408|O7|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
175886|NCT01656408|O6|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
175887|NCT01656408|O5|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
175888|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
175889|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
175890|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
175891|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
175892|NCT01656408|O13|Outcome|Screening|All enrolled participants, presents AEs with onset before first dose of study drug
175893|NCT01656408|O12|Outcome|Post Study|All enrolled participants, presents AEs with onset after safety follow-up period after last dose of study drug
175894|NCT01656408|O11|Outcome|Placebo (Panel A - J)|Combines participants who received placebo in all panels
175895|NCT01656408|O10|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
175896|NCT01656408|O9|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
175897|NCT01656408|O8|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
175898|NCT01656408|O7|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
175899|NCT01656408|O6|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
175900|NCT01656408|O5|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
175901|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
175902|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
175903|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
175904|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
175905|NCT01656408|E13|Reported Event|Screening|All enrolled participants, presents AEs with onset before first dose of study drug
175906|NCT01656408|E12|Reported Event|Post Study|All enrolled participants, presents AEs with onset after safety follow-up period after last dose of study drug
175907|NCT01656408|E11|Reported Event|Placebo (Panel A - J)|Combines participants who received placebo in all panels
175908|NCT01656408|E10|Reported Event|Panel J – MK-8150 10/20 mgEdit|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
175909|NCT01656408|E9|Reported Event|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
175910|NCT01656408|E8|Reported Event|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
175911|NCT01656408|E7|Reported Event|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
175912|NCT01656408|E6|Reported Event|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
175913|NCT01656408|E5|Reported Event|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
175914|NCT01656408|E4|Reported Event|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
175915|NCT01656408|E3|Reported Event|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
175916|NCT01656408|E2|Reported Event|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
175917|NCT01656408|E1|Reported Event|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
175918|NCT01656304|B1|Baseline|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
175919|NCT01656304|P1|Participant Flow|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
175920|NCT01656304|O1|Outcome|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
175921|NCT01656304|O1|Outcome|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
175922|NCT01656304|O1|Outcome|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
175923|NCT01656304|E1|Reported Event|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
175932|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175924|NCT01656252|B1|Baseline|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175925|NCT01656252|P1|Participant Flow|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175926|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175927|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175928|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175929|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175930|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175931|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175965|NCT01656161|O1|Outcome|Triptorelin Embonate 22.5 mg|Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
175966|NCT01656161|O1|Outcome|Triptorelin Embonate 22.5 mg|Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
175967|NCT01656161|O1|Outcome|Triptorelin Embonate 22.5 mg|Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
175968|NCT01656161|O1|Outcome|Triptorelin Embonate 22.5 mg|Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
175933|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175934|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175935|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175936|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175937|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175938|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175939|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175940|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175969|NCT01656161|E1|Reported Event|Triptorelin Embonate 22.5 mg|Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
175970|NCT01656031|B1|Baseline|High-dose Cytarabine and Clofarabine|high-dose cytarabine administered intravenously over 3 hours followed by clofarabine administered intravenously over 2 hours daily for 5 consecutive days
175971|NCT01656031|P1|Participant Flow|High-dose Cytarabine and Clofarabine|high-dose cytarabine administered intravenously over 3 hours followed by clofarabine administered intravenously over 2 hours daily for 5 consecutive days
175972|NCT01656031|O1|Outcome|High-Dose Cytarabine and Clofarabine|
175941|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175942|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175943|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175944|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175945|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175946|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175947|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175948|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175973|NCT01656031|E1|Reported Event|High-Dose Cytarabine and Clofarabine|
175974|NCT01655719|B1|Baseline|Pioglitazone Treatment|Part 1: In the initial main portion of the study subjects will receive 24 -28 weeks of therapy with pioglitazone at the dosage approved for the control of diabetes. Response will be evaluated per RECIST. Safety measure are outlined in the protocol including weekly weigh ins, calls, labs, exams, etc.
176010|NCT01655329|O8|Outcome|Need for Window/Level Manipulation|The standard image required less window/level manipulation
176011|NCT01655329|O7|Outcome|Confidence on Line Placement|The modified image increased my confidence with respect to line placement
185383|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
175949|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175950|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175951|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175952|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175953|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175954|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175955|NCT01656252|E1|Reported Event|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
175956|NCT01656161|B1|Baseline|Triptorelin Embonate 22.5 mg|Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
175957|NCT01656161|P1|Participant Flow|Triptorelin Embonate 22.5 mg|Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
175958|NCT01656161|O1|Outcome|PK/PD Subset|PK/PD subset of 15 participants included in the ITT analysis set.
175959|NCT01656161|O1|Outcome|PK/PD Subset of 15 Participants|Pharmacokinetic/pharmacodynamic subset of 15 participants who received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
175960|NCT01656161|O1|Outcome|PK/PD Subset|PK/PD subset of 15 participants included in the ITT analysis set.
175961|NCT01656161|O1|Outcome|PK/PD Subset|PK/PD subset of 15 participants included in the ITT analysis set.
175962|NCT01656161|O1|Outcome|PK/PD Subset|PK/PD subset of 15 participants included in the ITT analysis set.
175963|NCT01656161|O1|Outcome|PK/PD Subset|PK/PD subset of 15 participants included in the ITT analysis set.
175964|NCT01656161|O1|Outcome|PK/PD Subset|Pharmacokinetic/pharmacodynamic (PK/PD) subset of 15 participants included in the ITT analysis set.
175975|NCT01655719|P1|Participant Flow|Pioglitazone Treatment|"If eligible, subjects can participate in 1 or both parts of this study as follows:~Part 1: In the initial main portion of the study subjects will receive 24 -28 weeks of therapy with pioglitazone at the dosage approved for the control of diabetes. Response will be evaluated per RECIST. Safety measure are outlined in the protocol including weekly weigh ins, calls, labs, exams, etc.~Part 2: A secondary protocol is then available to subjects who complete the main initial study with less than complete response per RECIST. They can undergo a radioiodine scan to see if the treatment with pioglitazone has sensitized their disease to radioiodine. If it has - they can pursue the radioiodine treatment.~Pioglitazone"
175976|NCT01655719|O1|Outcome|Pioglitazone Treatment|Part 1: In the initial main portion of the study subjects will receive 24 -28 weeks of therapy with pioglitazone at the dosage approved for the control of diabetes. Response will be evaluated per RECIST. Safety measure are outlined in the protocol including weekly weigh ins, calls, labs, exams, etc.
175977|NCT01655719|O1|Outcome|Pioglitazone Treatment|Part 1: In the initial main portion of the study subjects will receive 24 -28 weeks of therapy with pioglitazone at the dosage approved for the control of diabetes. Response will be evaluated per RECIST. Safety measure are outlined in the protocol including weekly weigh ins, calls, labs, exams, etc.
175978|NCT01655719|O1|Outcome|Pioglitazone Treatment|Part 1: In the initial main portion of the study subjects will receive 24 -28 weeks of therapy with pioglitazone at the dosage approved for the control of diabetes. Response will be evaluated per RECIST. Safety measure are outlined in the protocol including weekly weigh ins, calls, labs, exams, etc.
175979|NCT01655719|E1|Reported Event|Pioglitazone Treatment|Part 1: In the initial main portion of the study subjects will receive 24 -28 weeks of therapy with pioglitazone at the dosage approved for the control of diabetes. Response will be evaluated per RECIST. Safety measure are outlined in the protocol including weekly weigh ins, calls, labs, exams, etc.
175980|NCT01655498|B1|Baseline|All Subjects|All subjects who completed the fitting process (a screening criteria) and entered the treatment period.
175981|NCT01655498|P1|Participant Flow|All Subjects|All subjects who completed the fitting process and entered the treatment period, comprised the Intent-to-treat population.
175982|NCT01655498|O1|Outcome|ITT Cohort [N=61]|All subjects who entered the Treatment Period.
175983|NCT01655498|O1|Outcome|Subject Fit With the VBC Device [PP]|Per Protocol cohort is defined all all subjects who were successfully fit with a VBC device (now called Eclipse Insert) during the Fitting Period who also completed the study without any major protocol deviations
175984|NCT01655498|O2|Outcome|Subject Fit With the VBC Device [PP]|Per Protocol cohort is defined all all subjects who were successfully fit with a VBC device (now called Eclipse Insert) during the Fitting Period who also completed the study without any major protocol deviations
175985|NCT01655498|O1|Outcome|Subjects Fit With the VBC Device [ITT]|ITT cohort is defined as all subjects who were successfully fit with a VBC device (now called Eclipse Insert) during the Fitting Period
175986|NCT01655498|E1|Reported Event|ITT Cohort [N=61]|Adverse Events reported during the Screening and 1-Month Treatment Period.
175987|NCT01655381|B1|Baseline|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
175988|NCT01655381|P1|Participant Flow|Tocilizumab|Tocilizumab 8 milligrams per kilogram (mg/kg) administered intravenously once every 4 weeks during a minimum of 104 weeks.
175989|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks through Week 104.
175990|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks through Week 104.
175991|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
175992|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
175993|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
175994|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
175995|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
175996|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
175997|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
175998|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
175999|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
176000|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
176001|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
176002|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
176003|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
176004|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
176005|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
176006|NCT01655381|E1|Reported Event|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
176007|NCT01655329|B1|Baseline|Radiologists|Board Certified Radiologists
176008|NCT01655329|P1|Participant Flow|Chest Radiographs|The radiologists will be viewing two groups of chest images. The first group are standard chest radiographs. The second group are the processed images. These radiographs were randomly placed into two groups. The radiologists were randomly placed in two groups. Each of these two groups interpreted half of the standard chest radiograph without processing and half with the special processing. The other group of radiologists interpreted the other half of the normal and the other half of the processed images. The radiologists reviewed each radiograph using one or the alternate presentation
176009|NCT01655329|O9|Outcome|Confidence on Tube Placement|The confirm image increases my confidence with respect to tube placement.
176012|NCT01655329|O6|Outcome|Image Quality Radioopaque Regions|Image quality in the opaque image areas is superior on the confirm image
176013|NCT01655329|O5|Outcome|Overall Image Quality|Overall image quality is superior on the standard image
176014|NCT01655329|O4|Outcome|Cardiac Related Wires|Cardiac related wires are easier to see on the standard image
176015|NCT01655329|O3|Outcome|Venous Catheters|Venous catheters easier to see on modified image
176016|NCT01655329|O2|Outcome|Pleural Drain Visibility|Pleural drains are easier to see on the standard image.
176017|NCT01655329|O1|Outcome|Reading Time Estimate by Radiologists|The modified image will reduce reading time.
176018|NCT01655329|O2|Outcome|Modified Chest Radiographs|This group of chest radiographs will be presented with the modified image. The modified image is intended to increase the visibility of tubes, lines and wires on chest radiographs. Each radiologist interpreted half the images as conventional images and half as processed images.
176019|NCT01655329|O1|Outcome|Standard Chest Radiographs|The radiologists will be viewing two groups of chest images. The first group are standard chest radiographs. The second group are the processed images. These radiographs were randomly placed into two groups. The radiologists were randomly placed in two groups. Each of these two groups interpreted half of the standard chest radiograph without processing and half with the special processing. The other group of radiologists interpreted the other half of the normal and the other half of the processed images.
176020|NCT01655329|O2|Outcome|Modified Chest Radiographs|This group of chest radiographs will be presented with the modified image. The modified image is intended to increase the visibility of tubes, lines and wires on chest radiographs. Each radiologist interpreted half the images as conventional images and half as processed images.
176021|NCT01655329|O1|Outcome|Standard Chest Radiographs|The radiologists will be viewing two groups of chest images. The first group are standard chest radiographs. The second group are the processed images. These radiographs were randomly placed into two groups. The radiologists were randomly placed in two groups. Each of these two groups interpreted half of the standard chest radiograph without processing and half with the special processing. The other group of radiologists interpreted the other half of the normal and the other half of the processed images.
176022|NCT01655329|E1|Reported Event|Radiologists|
176023|NCT01655069|B5|Baseline|Total|Total of all reporting groups
176024|NCT01655069|B4|Baseline|Adolescents Treated With Solifenacin in 905-CL-076|Male and female adolescents aged 12 to less than 18 years old who received solifenacin in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.
176025|NCT01655069|B3|Baseline|Adolescents Treated With Placebo in 905-CL-076|Male and female adolescents aged 12 to less than 18 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.
176026|NCT01655069|B2|Baseline|Children Treated With Solifenacin in 905-CL-076|Male and female children aged 5 to less than 12 years old who received solifenacin in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.
176027|NCT01655069|B1|Baseline|Children Treated With Placebo in 905-CL-076|Male and female children aged 5 to less than 12 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.
176028|NCT01655069|P4|Participant Flow|Adolescents Treated With Solifenacin in 905-CL-076|Male and female adolescents aged 12 to less than 18 years old who received solifenacin in Study 905- CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.
176029|NCT01655069|P3|Participant Flow|Adolescents Treated With Placebo in 905-CL-076|Male and female adolescents aged 12 to less than 18 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.
176030|NCT01655069|P2|Participant Flow|Children Treated With Solifenacin in 905-CL-076|Male and female children aged 5 to less than 12 years old who received solifenacin in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.
176031|NCT01655069|P1|Participant Flow|Children Treated With Placebo in 905-CL-076|Male and female children aged 5 to less than 12 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.
176032|NCT01655069|O2|Outcome|Adolescents (Aged 12 to Less Than 18 Years)|Adolescents aged 12 to less than 18 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.
176033|NCT01655069|O1|Outcome|Children (Aged 5 to Less Than 12 Years)|Children aged 5 to less than 12 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.
176034|NCT01655069|O1|Outcome|Adolescents (Aged 12 to Less Than 18 Years)|Adolescents aged 12 to less than 18 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.
176035|NCT01655069|O2|Outcome|Adolescents (Aged 12 to Less Than 18 Years)|Adolescents aged 12 to less than 18 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.
176036|NCT01655069|O1|Outcome|Children (Aged 5 to Less Than 12 Years)|Children aged 5 to less than 12 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.
176037|NCT01655069|O2|Outcome|Adolescents (Aged 12 to Less Than 18 Years)|Adolescents aged 12 to less than 18 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.
176038|NCT01655069|O1|Outcome|Children (Aged 5 to Less Than 12 Years)|Children aged 5 to less than 12 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.
176039|NCT01655069|O2|Outcome|Adolescents (Aged 12 to Less Than 18 Years)|Adolescents aged 12 to less than 18 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.
176040|NCT01655069|O1|Outcome|Children (Aged 5 to Less Than 12 Years)|Children aged 5 to less than 12 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults
176041|NCT01655069|O2|Outcome|Adolescents (Aged 12 to Less Than 18 Years)|Adolescents aged 12 to less than 18 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.
176042|NCT01655069|O1|Outcome|Children (Aged 5 to Less Than 12 Years)|Children aged 5 to less than 12 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.
176043|NCT01655069|E2|Reported Event|Adolescents (Aged 12 to Less Than 18 Years)|Adolescents aged 12 to less than 18 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.
176044|NCT01655069|E1|Reported Event|Children (Aged 5 to Less Than 12 Years|Children aged 5 to less than 12 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.
176045|NCT01655043|B1|Baseline|Coronary Artery Disease Patients|Patients with suspected coronary artery disease prospectively recruited for myocardial perfusion MRI. All subjects to receive 5 ml IV gadofoveset trisodium contrast (Ablavar, Lantheus) at both stress and rest. Stress to be induced using 5 ml intravenous (IV) regadenoson (Lexiscan, Astellas US LLC), and the effects of regadenoson were reversed with 50 mg IV aminophylline following the completion of stress imaging.
176046|NCT01655043|P1|Participant Flow|Coronary Artery Disease Patients|Patients with suspected coronary artery disease prospectively recruited for myocardial perfusion MRI. All subjects to receive 5 ml IV gadofoveset trisodium contrast (Ablavar, Lantheus) at both stress and rest. Stress to be induced using 5 ml intravenous (IV) regadenoson (Lexiscan, Astellas US LLC), and the effects of regadenoson were reversed with 50 mg IV aminophylline following the completion of stress imaging.
176047|NCT01655043|O1|Outcome|Coronary Artery Disease Patients|Patients with suspected coronary artery disease prospectively recruited for myocardial perfusion MRI. All subjects to receive 5 ml IV gadofoveset trisodium contrast (Ablavar, Lantheus) at both stress and rest. Stress to be induced using 5 ml intravenous (IV) regadenoson (Lexiscan, Astellas US LLC), and the effects of regadenoson were reversed with 50 mg IV aminophylline following the completion of stress imaging.
176048|NCT01655043|E1|Reported Event|Coronary Artery Disease Patients|Patients with suspected coronary artery disease prospectively recruited for myocardial perfusion MRI. All subjects to receive 5 ml IV gadofoveset trisodium contrast (Ablavar, Lantheus) at both stress and rest. Stress to be induced using 5 ml intravenous (IV) regadenoson (Lexiscan, Astellas US LLC), and the effects of regadenoson were reversed with 50 mg IV aminophylline following the completion of stress imaging.
176049|NCT01654887|B3|Baseline|Total|Total of all reporting groups
176050|NCT01654887|B2|Baseline|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
176051|NCT01654887|B1|Baseline|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
176052|NCT01654887|P2|Participant Flow|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
176053|NCT01654887|P1|Participant Flow|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
176054|NCT01654887|O2|Outcome|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
176055|NCT01654887|O1|Outcome|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
176056|NCT01654887|O2|Outcome|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
176057|NCT01654887|O1|Outcome|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
176058|NCT01654887|O2|Outcome|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
176059|NCT01654887|O1|Outcome|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
176060|NCT01654887|O2|Outcome|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
176061|NCT01654887|O1|Outcome|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
176062|NCT01654887|O2|Outcome|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
176063|NCT01654887|O1|Outcome|Lung Ultrasound|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
176064|NCT01654887|O2|Outcome|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
176065|NCT01654887|O1|Outcome|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
176066|NCT01654887|E2|Reported Event|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
176067|NCT01654887|E1|Reported Event|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
176068|NCT01654861|B1|Baseline|HDIVC|"Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).~Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment."
176069|NCT01654861|P1|Participant Flow|HDIVC|"Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).~Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment."
176070|NCT01654861|O1|Outcome|HDIVC|"Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).~Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment."
176071|NCT01654861|O1|Outcome|HDIVC|"Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).~Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment."
176072|NCT01654861|E1|Reported Event|HDIVC|"Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).~Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment."
176073|NCT01654796|B4|Baseline|Total|Total of all reporting groups
176074|NCT01654796|B3|Baseline|Crossover Arm|"Patients in this group will receive two days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by two days of active low field magnetic stimulation (LFMS) in phase 2.~Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.~Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation."
176075|NCT01654796|B2|Baseline|Sham (LFMS)|"Patients in this arm will receive 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 2.~Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation."
176076|NCT01654796|B1|Baseline|Low Field Magnetic Stimulation|"Patients in this arm will receive 2 days of active low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of active low field magnetic stimulation (LFMS) in phase 2. LFMS is a novel, non-contact neuromodulation technique. LFMS is administered through a device while the patient lies on his/her back for 20 minutes.~Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression."
176077|NCT01654796|P3|Participant Flow|Sham LFMS First, Then Active LFMS|"Patients in this group will receive two days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by two days of active low field magnetic stimulation (LFMS) in phase 2.~Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.~Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation."
176078|NCT01654796|P2|Participant Flow|Sham (LFMS)|"Patients in this arm will receive 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 2.~Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation."
176079|NCT01654796|P1|Participant Flow|Low Field Magnetic Stimulation|"Patients in this arm will receive 2 days of active low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of active low field magnetic stimulation (LFMS) in phase 2. LFMS is a novel, non-contact neuromodulation technique. LFMS is administered through a device while the patient lies on his/her back for 20 minutes.~Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression."
176080|NCT01654796|O4|Outcome|Phase 2 Sham LFMS|Participants in this group received Sham LFMS treatment for 2 days in Phase 2.
176081|NCT01654796|O3|Outcome|Phase 2 Active LFMS|Participants in this group received Active LFMS treatment for 2 days in Phase 2.
176082|NCT01654796|O2|Outcome|Phase 1 Sham LFMS|Participants in this group received Sham LFMS treatment for 2 days in Phase 1.
176083|NCT01654796|O1|Outcome|Phase 1 Active LFMS|Participants in this group receive Active LFMS treatment for 2 days in Phase 1.
176084|NCT01654796|E3|Reported Event|Crossover Arm|"Patients in this group will receive two days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by two days of active low field magnetic stimulation (LFMS) in phase 2.~Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.~Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation."
176085|NCT01654796|E2|Reported Event|Sham (LFMS)|"Patients in this arm will receive 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 2.~Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation."
176086|NCT01654796|E1|Reported Event|Low Field Magnetic Stimulation|"Patients in this arm will receive 2 days of active low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of active low field magnetic stimulation (LFMS) in phase 2. LFMS is a novel, non-contact neuromodulation technique. LFMS is administered through a device while the patient lies on his/her back for 20 minutes.~Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression."
176087|NCT01654666|B4|Baseline|Total|Total of all reporting groups
176088|NCT01654666|B3|Baseline|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176089|NCT01654666|B2|Baseline|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176090|NCT01654666|B1|Baseline|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176091|NCT01654666|P3|Participant Flow|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176092|NCT01654666|P2|Participant Flow|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176093|NCT01654666|P1|Participant Flow|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176094|NCT01654666|O3|Outcome|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176095|NCT01654666|O2|Outcome|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176096|NCT01654666|O1|Outcome|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176097|NCT01654666|O3|Outcome|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176098|NCT01654666|O2|Outcome|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176099|NCT01654666|O1|Outcome|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176100|NCT01654666|O3|Outcome|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176101|NCT01654666|O2|Outcome|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176102|NCT01654666|O1|Outcome|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176103|NCT01654666|O3|Outcome|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176104|NCT01654666|O2|Outcome|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176105|NCT01654666|O1|Outcome|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176106|NCT01654666|O3|Outcome|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176107|NCT01654666|O2|Outcome|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176108|NCT01654666|O1|Outcome|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176109|NCT01654666|O3|Outcome|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176110|NCT01654666|O2|Outcome|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176111|NCT01654666|O1|Outcome|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176112|NCT01654666|E3|Reported Event|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176113|NCT01654666|E2|Reported Event|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176114|NCT01654666|E1|Reported Event|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
176115|NCT01654601|B3|Baseline|Total|Total of all reporting groups
176116|NCT01654601|B2|Baseline|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
176117|NCT01654601|B1|Baseline|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
176118|NCT01654601|P2|Participant Flow|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
176119|NCT01654601|P1|Participant Flow|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
176120|NCT01654601|O2|Outcome|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
176121|NCT01654601|O1|Outcome|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
176122|NCT01654601|O2|Outcome|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
176123|NCT01654601|O1|Outcome|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
176124|NCT01654601|O2|Outcome|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
176125|NCT01654601|O1|Outcome|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
176126|NCT01654601|O2|Outcome|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
176127|NCT01654601|O1|Outcome|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
176128|NCT01654601|E2|Reported Event|B Group|1.1st Administration - Clozaril tablet 100mg Mutiple dose 2.2nd Administration - DWCZP tablet 100mg Mutiple dose
176129|NCT01654601|E1|Reported Event|A Group|1.1st Administration - DWCZP tablet 100mg Mutiple dose 2.2nd Administration - Clozaril tablet 100mg Mutiple dose
176130|NCT01654549|B3|Baseline|Total|Total of all reporting groups
176131|NCT01654549|B2|Baseline|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
176132|NCT01654549|B1|Baseline|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
176133|NCT01654549|P2|Participant Flow|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
176134|NCT01654549|P1|Participant Flow|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
176135|NCT01654549|O6|Outcome|Liver Fat Content Change in Lifestyle Modification|The change of liver fat content from baseline to the end of study in lifestyle modification group
176136|NCT01654549|O5|Outcome|Liver Fat Content Change in H.Pylori Eradication|The change of liver fat content from baseline to the end of study in H.pylori eradication group
176137|NCT01654549|O4|Outcome|Liver Fat Content in Lifestyle Modification at 8 Weeks|Liver fat content in lifestyle modification group at 8 weeks
176138|NCT01654549|O3|Outcome|Liver Fat Content in Lifestyle Modification at Baseline|Liver fat content in lifestyle modification group at baseline
176139|NCT01654549|O2|Outcome|Liver Fat Content in H.Pylori Eradication at 8 Weeks|Liver fat content in Helicobacter pylori eradication plus lifestyle modification group at 8 weeks
176140|NCT01654549|O1|Outcome|Liver Fat Content in H.Pylori Eradication at Baseline|Liver fat content in Helicobacter pylori eradication plus lifestyle modification group at baseline
176141|NCT01654549|E2|Reported Event|No Intervention|Lifestyle modification
176142|NCT01654549|E1|Reported Event|H. Pylori Eradication|Helicobacter pylori eradication
176143|NCT01654536|B3|Baseline|Total|Total of all reporting groups
176144|NCT01654536|B2|Baseline|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
176145|NCT01654536|B1|Baseline|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
176146|NCT01654536|P2|Participant Flow|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
176147|NCT01654536|P1|Participant Flow|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
176148|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
176149|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
176150|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
176151|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
176152|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
176747|NCT01652729|B1|Baseline|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
176153|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
176154|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
176155|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
176156|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
176157|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
176158|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
176159|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
176160|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
176161|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
176162|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
176163|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
176164|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
176165|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
176166|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
176167|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
176168|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
176169|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetona (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
176170|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
176171|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
176172|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
176173|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
176174|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
176175|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
176176|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
176177|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
176178|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
176179|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
176180|NCT01654536|E2|Reported Event|Ciclesonide Nasal Spray|"ciclesonide nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
176181|NCT01654536|E1|Reported Event|Ciclesonide Nasal Aerosol|"ciclesonide nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
176182|NCT01654523|B1|Baseline|Treatment Arm|"Open trial with no randomization~Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania"
176183|NCT01654523|P1|Participant Flow|Awareness Enhancement and Monitoring Device|"Open trial with no randomization~Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania"
176184|NCT01654523|O1|Outcome|Awareness Enhancement and Monitoring Device|"Open trial with no randomization~Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania"
176185|NCT01654523|E1|Reported Event|Treatment Arm|"Open trial with no randomization~Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania"
176186|NCT01654302|B3|Baseline|Total|Total of all reporting groups
176187|NCT01654302|B2|Baseline|Placebo Then Synera|Subjects received the Inactive patch (placebo) during the First Intervention (Day 1) and the Synera patch at the Second Intervention (Day 7).
176188|NCT01654302|B1|Baseline|Synera Then Placebo|Subjects received the Synera patch during the First Intervention (Day 1) and the Inactive patch (placebo) at the Second Intervention (Day 7).
176189|NCT01654302|P2|Participant Flow|Placebo Then Synera|Subjects received the Inactive patch (placebo) during the First Intervention (Day 1) and the Synera patch at the Second Intervention (Day 7).
176190|NCT01654302|P1|Participant Flow|Synera Then Placebo|Subjects received the Synera patch during the First Intervention (Day 1) and the Inactive patch at the Second Intervention (Day 7).
176191|NCT01654302|O2|Outcome|Inactive Patch|placebo: placebo
176192|NCT01654302|O1|Outcome|Synera|70 mg lidocaine/ 70 mg tetracaine topical patch: 70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours
176193|NCT01654302|E2|Reported Event|Inactive Patch|placebo: placebo
176194|NCT01654302|E1|Reported Event|Synera|70 mg lidocaine/ 70 mg tetracaine topical patch: 70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours
176195|NCT01654276|B1|Baseline|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
176196|NCT01654276|P1|Participant Flow|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
176197|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
176198|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
176199|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
176200|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
176201|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
176202|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
176203|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
176204|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
176205|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
176206|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
176207|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
176208|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
176209|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
176210|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
176211|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
176212|NCT01654276|E1|Reported Event|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
176213|NCT01654263|B7|Baseline|Total|Total of all reporting groups
176214|NCT01654263|B6|Baseline|IIBB: Age 65-74, Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
176687|NCT01653028|B2|Baseline|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176215|NCT01654263|B5|Baseline|IIAA: Age 55-64, Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
176216|NCT01654263|B4|Baseline|IIB: Age 65-74, Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
176217|NCT01654263|B3|Baseline|IIA: Age 55-64, Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
176218|NCT01654263|B2|Baseline|IB: Pneumococcal Vaccine-naive, Age 65-74, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 65-74.
176219|NCT01654263|B1|Baseline|IA: Pneumococcal Vaccine-naive, Age 55-64, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-64.
176220|NCT01654263|P6|Participant Flow|IIBB: Age 65 - 74, Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
176221|NCT01654263|P5|Participant Flow|IIAA: Age 55-64, Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
176222|NCT01654263|P4|Participant Flow|IIB: Age 65-74, Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
176223|NCT01654263|P3|Participant Flow|IIA: Age 55-64, Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
176224|NCT01654263|P2|Participant Flow|IB: Pneumococcal Vaccine-naive, Age 65-74, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 65-74.
176225|NCT01654263|P1|Participant Flow|IA: Pneumococcal Vaccine-naive, Age 55-64, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-64.
176226|NCT01654263|O3|Outcome|Group IIAA/BB: Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
176227|NCT01654263|O2|Outcome|Group IIA/B: Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
176228|NCT01654263|O1|Outcome|Group IA/B: Pneumococcal Vaccine-naive, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-74.
176229|NCT01654263|O3|Outcome|Group IIAA/BB: Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
176230|NCT01654263|O2|Outcome|Group IIA/B: Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
176231|NCT01654263|O1|Outcome|Group IA/B: Pneumococcal Vaccine-naive, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-74.
176232|NCT01654263|O3|Outcome|Group IIAA/BB: Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
176233|NCT01654263|O2|Outcome|Group IIA/B: Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
176234|NCT01654263|O1|Outcome|Group IA/B: Pneumococcal Vaccine-naive, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-74.
176235|NCT01654263|O3|Outcome|Group IIAA/BB: Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
176236|NCT01654263|O2|Outcome|Group IIA/B: Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
176237|NCT01654263|O1|Outcome|Group IA/B: Pneumococcal Vaccine-naive, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-74.
176238|NCT01654263|O3|Outcome|Group IIAA/BB: Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
176239|NCT01654263|O2|Outcome|Group IIA/B: Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
176240|NCT01654263|O1|Outcome|Group IA/B: Pneumococcal Vaccine-naive, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-74.
176416|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176241|NCT01654263|E6|Reported Event|IIBB: Previous PPSV23, Age 65-74, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
176242|NCT01654263|E5|Reported Event|IIAA: Previous PPSV23, Age 55-64, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
176243|NCT01654263|E4|Reported Event|IIB: Previous PPSV23, Age 65-74, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
176244|NCT01654263|E3|Reported Event|IIA: Previous PPSV23, Age 55-64, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
176245|NCT01654263|E2|Reported Event|IB: Pneumococcal Vaccine-naive, Age 65-74, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 65-74.
176246|NCT01654263|E1|Reported Event|IA: Pneumococcal Vaccine-naive, Age 55-64, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-64.
176247|NCT01654250|B3|Baseline|Total|Total of all reporting groups
176248|NCT01654250|B2|Baseline|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
176249|NCT01654250|B1|Baseline|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
176250|NCT01654250|P2|Participant Flow|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
176251|NCT01654250|P1|Participant Flow|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
176252|NCT01654250|O1|Outcome|Entire Study Population|All randomized participants received either placebo-matched to NW09 or NW09 chewable tablets once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
176253|NCT01654250|O1|Outcome|Entire Study Population|All randomized participants received either placebo-matched to NW09 or NW09 chewable tablets once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
176254|NCT01654250|O1|Outcome|Entire Study Population|All randomized participants received either placebo-matched to NW09 or NW09 chewable tablets once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
176255|NCT01654250|O2|Outcome|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
176256|NCT01654250|O1|Outcome|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
176257|NCT01654250|O2|Outcome|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
176258|NCT01654250|O1|Outcome|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
176259|NCT01654250|O2|Outcome|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
176260|NCT01654250|O1|Outcome|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
176261|NCT01654250|O2|Outcome|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
176262|NCT01654250|O1|Outcome|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
176263|NCT01654250|E2|Reported Event|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
176745|NCT01652729|B3|Baseline|Placebo Comparator: Placebo|Placebo oral tablet once daily
176264|NCT01654250|E1|Reported Event|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
176265|NCT01654224|B3|Baseline|Total|Total of all reporting groups
176266|NCT01654224|B2|Baseline|SD IIV|Frail adults 65 years and older who received Fluzone Standard Dose intramuscularly
176267|NCT01654224|B1|Baseline|HD IIV|Frail adults 65 years and older who received Fluzone High Dose intramuscularly
176268|NCT01654224|P2|Participant Flow|SD IIV|Frail adults 65 years or older who received Fluzone Standard Dose intramuscularly
176269|NCT01654224|P1|Participant Flow|HD IIV|Frail adults 65 years or older who received Fluzone High Dose intramuscularly.
176270|NCT01654224|O2|Outcome|Standard Dose Inactivated Influenza Vaccine|"For SDIV, 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg of each strain) of influenza virus hemagglutinin~Standard Dose Inactivated Influenza Vaccine: 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg each strain) of influenza virus hemagglutinin"
176271|NCT01654224|O1|Outcome|High Dose Inactivated Influenza Vaccine|"For HDIV,0.5 ml of high dose inactivated influenza vaccine consisting of a total of 180mcg (60 mcg each strain) of influenza virus hemagglutinin~High Dose Inactivated Influenza Vaccine: 0.5 ml HDIV consisting of 180 mcg (60 mcg each strain) of influenza virus hemagglutinin"
176272|NCT01654224|O2|Outcome|Standard Dose Inactivated Influenza Vaccine|"For SDIV, 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg of each strain) of influenza virus hemagglutinin~Standard Dose Inactivated Influenza Vaccine: 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg each strain) of influenza virus hemagglutinin"
176273|NCT01654224|O1|Outcome|High Dose Inactivated Influenza Vaccine|"For HDIV,0.5 ml of high dose inactivated influenza vaccine consisting of a total of 180mcg (60 mcg each strain) of influenza virus hemagglutinin~High Dose Inactivated Influenza Vaccine: 0.5 ml HDIV consisting of 180 mcg (60 mcg each strain) of influenza virus hemagglutinin"
176274|NCT01654224|O2|Outcome|Standard Dose Inactivated Influenza Vaccine|"For SDIV, 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg of each strain) of influenza virus hemagglutinin~Standard Dose Inactivated Influenza Vaccine: 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg each strain) of influenza virus hemagglutinin"
176275|NCT01654224|O1|Outcome|High Dose Inactivated Influenza Vaccine|"For HDIV,0.5 ml of high dose inactivated influenza vaccine consisting of a total of 180mcg (60 mcg each strain) of influenza virus hemagglutinin~High Dose Inactivated Influenza Vaccine: 0.5 ml HDIV consisting of 180 mcg (60 mcg each strain) of influenza virus hemagglutinin"
176276|NCT01654224|E2|Reported Event|SD IIV|Frail adults 65 years or older who received Fluzone Standard Dose intramuscularly
176277|NCT01654224|E1|Reported Event|HD IIV|Frail adults 65 years or older who received Fluzone High Dose intramuscularly.
176278|NCT01654107|B3|Baseline|Total|Total of all reporting groups
176279|NCT01654107|B2|Baseline|Clearing The Air|"Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge~Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
176280|NCT01654107|B1|Baseline|Persistence Targeted Smoking Cessation|"Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge~Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling (Persistence Targeted Smoking Cessation)~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
176281|NCT01654107|P2|Participant Flow|Clearing The Air|"Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge~Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
176282|NCT01654107|P1|Participant Flow|Persistence Targeted Smoking Cessation|"Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge~Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling (Persistence Targeted Smoking Cessation)~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
176283|NCT01654107|O2|Outcome|Clearing The Air|"Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge~Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
176284|NCT01654107|O1|Outcome|Persistence Targeted Smoking Cessation|"Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge~Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling (Persistence Targeted Smoking Cessation)~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
176285|NCT01654107|E2|Reported Event|Clearing The Air|"Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge~Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
176286|NCT01654107|E1|Reported Event|Persistence Targeted Smoking Cessation|"Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge~Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling (Persistence Targeted Smoking Cessation)~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
176287|NCT01653964|B1|Baseline|Molecular Breast Imaging|"Molecular Breast Imaging at 4 mCi dose and at 8 mCi dose, consecutively.~Molecular breast imaging performed with injection of Tc-99m sestamibi and a dedicated gamma camera (Luma Gem, Gamma Medica)"
176288|NCT01653964|P1|Participant Flow|Molecular Breast Imaging|Molecular breast imaging performed after injection of 4 mCi Tc-99m sestamibi and again after 8 millicurie (mCi) Tc-99m sestamibi.
176289|NCT01653964|O1|Outcome|Molecular Breast Imaging|Molecular breast imaging performed after injection of 4 mCi Tc-99m sestamibi and again after 8 mCi Tc-99m sestamibi.
176290|NCT01653964|E1|Reported Event|Molecular Breast Imaging|"Molecular Breast Imaging at 4 mCi dose and at 8 mCi dose, consecutively.~Molecular breast imaging: Molecular breast imaging performed with injection of Tc-99m sestamibi and a dedicated gamma camera (Luma Gem, Gamma Medica)"
176291|NCT01653912|B3|Baseline|Total|Total of all reporting groups
176685|NCT01653028|B4|Baseline|Cohort4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176292|NCT01653912|B2|Baseline|Phase 2 (Treatment Group): GSK2110183|The dosing regimen identified in Phase 1 will then be evaluated in Phase 2, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity.
176293|NCT01653912|B1|Baseline|Phase 1 (Dose Escalation): GSK2110183|GSK2110183, either at 50 mg, 75 mg, 100 mg, 125 mg or 150 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.
176294|NCT01653912|P6|Participant Flow|Phase 2 (Treatment Group): GSK2110183 125 mg (MTD)|The dosing regimen identified in Phase I will then be evaluated in Phase II, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity.
176295|NCT01653912|P5|Participant Flow|Phase 1 (Dose Escalation)-Cohort 4: GSK2110183 150 mg|GSK2110183 150 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.
176296|NCT01653912|P4|Participant Flow|Phase 1 (Dose Escalation)-Cohort 3: GSK2110183 125 mg|GSK2110183 125 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.
176297|NCT01653912|P3|Participant Flow|Phase 1 (Dose Escalation)-Cohort 2: GSK2110183 100 mg|GSK2110183 100 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.
176298|NCT01653912|P2|Participant Flow|Phase 1 (Dose Escalation)-Cohort 1.5: GSK2110183 75 mg|GSK2110183 75 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.
176299|NCT01653912|P1|Participant Flow|Phase 1 (Dose Escalation)-Cohort 1: GSK2110183 50 mg|GSK2110183 50 mg capsule by mouth daily in combination with carboplatin Area Under the Curve (AUC) 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.
176300|NCT01653912|O1|Outcome|Phase 2 (Treatment Group): GSK2110183|The dosing regimen identified in Phase 1 will then be evaluated in Phase 2, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity.
176301|NCT01653912|O1|Outcome|Phase 2 (Treatment Group): GSK2110183|The dosing regimen identified in Phase 1 will then be evaluated in Phase 2, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity.
176302|NCT01653912|O1|Outcome|Phase 2 (Treatment Group): GSK2110183|The dosing regimen identified in Phase 1 will then be evaluated in Phase 2, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity.
176303|NCT01653912|O1|Outcome|Phase 2 (Treatment Group): GSK2110183|The dosing regimen identified in Phase 1 will then be evaluated in Phase 2, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity.
176304|NCT01653912|O1|Outcome|Phase 2 (Treatment Group): GSK2110183|The dosing regimen identified in Phase 1 will then be evaluated in Phase 2, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity.
176305|NCT01653912|O1|Outcome|Phase 1 (Dose Escalation): GSK2110183|GSK2110183, either at 50 mg, 75 mg, 100 mg, 125 mg or 150 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.
176306|NCT01653912|O1|Outcome|Phase 2 (Treatment Group): GSK2110183|The dosing regimen identified in Phase 1 will then be evaluated in Phase 2, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity.
176307|NCT01653912|O1|Outcome|Phase 2 (Treatment Group): GSK2110183|The dosing regimen identified in Phase 1 will then be evaluated in Phase 2, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity.
176308|NCT01653912|O1|Outcome|Phase 1 (Dose Escalation): GSK2110183|GSK2110183, either at 50 mg, 75 mg, 100 mg, 125 mg or 150 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.
176309|NCT01653912|O1|Outcome|Phase 1 (Dose Escalation): GSK2110183|GSK2110183, either at 50 mg, 75 mg, 100 mg, 125 mg or 150 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.
176310|NCT01653912|O1|Outcome|Phase 1 (Dose Escalation): GSK2110183|GSK2110183, either at 50 mg, 75 mg, 100 mg, 125 mg or 150 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.
176371|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
185384|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
176311|NCT01653912|E2|Reported Event|Phase 2 (Treatment Group): GSK2110183|The dosing regimen identified in Phase 1 will then be evaluated in Phase 2, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity.
176312|NCT01653912|E1|Reported Event|Phase 1 (Dose Escalation): GSK2110183|GSK2110183, either at 50 mg, 75 mg, 100 mg, 125 mg or 150 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles.
176313|NCT01653782|B4|Baseline|Total|Total of all reporting groups
176314|NCT01653782|B3|Baseline|Medical Yoga|Guided kundalini yoga sessions specific for low back pain for 2 hours, twice a week for 6 weeks. Cd recording for home practice recommended once per day.A written self care pamphlet
176315|NCT01653782|B2|Baseline|Self Care Advice to Stay Active|"Evidence based advice from caregiver to stay active and exercise~Self care advice : Evidence based advice from caregiver about keeping active, exercise and a written self care pamphlet"
176316|NCT01653782|B1|Baseline|Exercise|Guided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet
176317|NCT01653782|P3|Participant Flow|Medical Yoga|Guided kundalini yoga sessions specific for low back pain for 1 hour, twice a week (120 minutes of intructor-led yoga each week) for 6 weeks. Cd recording for home practice recommended once per day.A written self care pamphlet
176318|NCT01653782|P2|Participant Flow|Self Care Advice to Stay Active|"Evidence based advice from caregiver to stay active and exercise~Self care advice : Evidence based advice from caregiver about keeping active, exercise and a written self care pamphlet"
176319|NCT01653782|P1|Participant Flow|Exercise|Guided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet
176320|NCT01653782|O3|Outcome|Medical Yoga|Guided kundalini yoga sessions specific for low back pain for 1 hour, twice a week (120 minutes each week of instructor-led yoga) for 6 weeks. Cd recording for home practice recommended once per day.A written self care pamphlet
176321|NCT01653782|O2|Outcome|Self Care Advice to Stay Active|"Evidence based advice from caregiver to stay active and exercise~Self care advice : Evidence based advice from caregiver about keeping active, exercise and a written self care pamphlet"
176322|NCT01653782|O1|Outcome|Exercise|Guided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet
176323|NCT01653782|E3|Reported Event|Medical Yoga|Guided kundalini yoga sessions specific for low back pain for twice a week for 6 weeks. Cd recording for home practice recommended once per day.A written self care pamphlet
176324|NCT01653782|E2|Reported Event|Self Care Advice to Stay Active|"Evidence based advice from caregiver to stay active and exercise~Self care advice : Evidence based advice from caregiver about keeping active, exercise and a written self care pamphlet"
176325|NCT01653782|E1|Reported Event|Exercise|Guided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet
176326|NCT01653743|B3|Baseline|Total|Total of all reporting groups
176327|NCT01653743|B2|Baseline|Urinary Human Chorionic Gonadotropin (u-hCG)|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
176328|NCT01653743|B1|Baseline|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
176329|NCT01653743|P2|Participant Flow|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
176330|NCT01653743|P1|Participant Flow|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
176331|NCT01653743|O2|Outcome|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
176417|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176332|NCT01653743|O1|Outcome|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
176333|NCT01653743|O2|Outcome|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
176334|NCT01653743|O1|Outcome|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
176335|NCT01653743|O2|Outcome|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
176336|NCT01653743|O1|Outcome|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
176337|NCT01653743|O2|Outcome|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
176338|NCT01653743|O1|Outcome|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
176339|NCT01653743|O2|Outcome|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
176340|NCT01653743|O1|Outcome|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
176341|NCT01653743|E2|Reported Event|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
176372|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
176342|NCT01653743|E1|Reported Event|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
176343|NCT01653509|B3|Baseline|Total|Total of all reporting groups
176344|NCT01653509|B2|Baseline|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period. Baseline measures were determined for Safety population.
176345|NCT01653509|B1|Baseline|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period. Baseline measures were determined for Safety population.
176346|NCT01653509|P2|Participant Flow|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
176347|NCT01653509|P1|Participant Flow|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
176348|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area at a time. A maximum of 5 patches/ day were allowed during the 10 day study period.
176349|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area at a time. A maximum of 5 patches/ day were allowed during the 10 day study period.
176350|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
176351|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
176352|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
176353|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
176354|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
176355|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
176356|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
176357|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
176358|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
176359|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
176360|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
176361|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
176362|NCT01653509|E2|Reported Event|Placebo Patch|Participants applied single placebo patch to the cold sore area.
176363|NCT01653509|E1|Reported Event|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area.
176364|NCT01653418|B1|Baseline|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
176365|NCT01653418|P1|Participant Flow|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
176366|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
176367|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
176368|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
176369|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
176370|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
176746|NCT01652729|B2|Baseline|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
176373|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
176374|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
176375|NCT01653418|E1|Reported Event|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
176376|NCT01653262|B1|Baseline|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
176377|NCT01653262|P1|Participant Flow|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
176378|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
176379|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
176380|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
176381|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
176382|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
176383|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
176384|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
176385|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
176386|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
176387|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
176388|NCT01653262|E1|Reported Event|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
176389|NCT01653158|B1|Baseline|Entire Study Population|Includes all enrolled participants who received single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 0.1, 0.4, 0.8, 1.5, 3, 6, 10 or 20 mg/kg intravenously at each cycle (1 cycle = 21 days).
176390|NCT01653158|P8|Participant Flow|CP-751,871 20 mg/kg + Docetaxel|"In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days).~In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1."
176391|NCT01653158|P7|Participant Flow|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176392|NCT01653158|P6|Participant Flow|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176393|NCT01653158|P5|Participant Flow|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176394|NCT01653158|P4|Participant Flow|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176395|NCT01653158|P3|Participant Flow|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176396|NCT01653158|P2|Participant Flow|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176397|NCT01653158|P1|Participant Flow|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176398|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176399|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176400|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176401|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176402|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176403|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176404|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176405|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176406|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176407|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176408|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176409|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176410|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176411|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176412|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176413|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176414|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176415|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176686|NCT01653028|B3|Baseline|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176418|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176419|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176420|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176421|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176422|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176423|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176424|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176425|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176426|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176427|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176428|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176429|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176430|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176431|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176432|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176433|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176434|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176435|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176436|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176437|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176438|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176439|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176440|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176441|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176442|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176443|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176444|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176445|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176446|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176447|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176448|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176449|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176450|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176451|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176452|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176453|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176454|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176455|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176456|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176457|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176458|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176459|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176460|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176461|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176462|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176463|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176464|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176465|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176466|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176467|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176468|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176469|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176470|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176471|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176472|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176473|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176474|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176475|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176476|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176477|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176478|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176479|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176480|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176481|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176482|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176483|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176484|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176485|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176486|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176487|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176488|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176489|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176490|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176491|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176492|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176493|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176494|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176495|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176496|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176497|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176498|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176499|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176500|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176501|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176502|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176503|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176504|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176505|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176506|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176507|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176508|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176509|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176510|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176511|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176512|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176513|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176514|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176515|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176516|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176517|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176518|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176519|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176520|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176521|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176522|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176523|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176524|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176525|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176526|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176527|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176528|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176529|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176530|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176531|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176532|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176533|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176534|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176535|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176536|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176537|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176538|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176539|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176540|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176541|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176542|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176543|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176544|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176545|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176546|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176547|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176548|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176549|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176550|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176551|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176552|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176553|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176554|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176555|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176556|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176557|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176558|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176559|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176560|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176561|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176562|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176563|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176564|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176565|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176566|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176567|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176568|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176569|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176570|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176571|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176572|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176573|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176574|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176575|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176576|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176577|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176578|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176579|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176580|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176581|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176582|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176583|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176584|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176585|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176586|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176587|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176588|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176589|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176590|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176591|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176592|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176593|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176594|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176595|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176596|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176597|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176598|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176599|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176600|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176601|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176602|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176603|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176604|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176605|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176606|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176607|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176608|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176609|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176610|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176611|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176612|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176613|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176614|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
176615|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176616|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176617|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176618|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176619|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176620|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176621|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176622|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
176623|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176624|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176625|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176626|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176627|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176628|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176629|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176630|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
176631|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176632|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176633|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176634|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176635|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176636|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176637|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176682|NCT01653132|E1|Reported Event|Incobotulinum Toxin|Incobotulinum Toxin 100 units diluted in 1 ml of sterile 0.9% saline injected in the parotid (20 units, 0.2 ml each) and submandibular (30 units, 0.3ml each) glands of subjects
176683|NCT01653028|B6|Baseline|Total|Total of all reporting groups
176638|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
176639|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176640|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176641|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176642|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176643|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176644|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176645|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176646|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
176647|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
176648|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
176649|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
176650|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
176651|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
176652|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
176653|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
176654|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
176655|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
176656|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
176684|NCT01653028|B5|Baseline|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
185385|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
176657|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
176658|NCT01653158|O1|Outcome|CP-751,871 0.1-20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1, 0.4, 0.8, 1.5, 3, 6, 10 or 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
176659|NCT01653158|O1|Outcome|CP-751,871 0.1-20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1, 0.4, 0.8, 1.5, 3, 6, 10 or 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176660|NCT01653158|E8|Reported Event|CP-751,871 20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
176661|NCT01653158|E7|Reported Event|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176662|NCT01653158|E6|Reported Event|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176663|NCT01653158|E5|Reported Event|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176664|NCT01653158|E4|Reported Event|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176665|NCT01653158|E3|Reported Event|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176666|NCT01653158|E2|Reported Event|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
176667|NCT01653158|E1|Reported Event|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
176668|NCT01653132|B1|Baseline|All Study Participants|Participants who received either Placebo, 1ml of preservative free sterile 0.9% saline, injected into the parotid (0.2 ml each) and submandibular ( 0.3 ml each), or Incobotulinum Toxin A 100 units, 20 units (0.2 ml) of Inco-A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland using anatomical landmarks
176669|NCT01653132|P2|Participant Flow|Incobotulinum Toxin A First, Then Placebo|Incobotulinum toxin, 100 units, diluted in 1 ml 0.9% sterile saline. 20 units (0.2 ml) were injected into each parotid gland and 30 units (0.3 ml) into each submandibular gland using anatomical landmarks
176670|NCT01653132|P1|Participant Flow|Placebo First, Then Incobotulinum Toxin A|sterile, preservative free 0.9% saline, 1 ml of saline into the parotid and submandibular glands in first intervention period
176671|NCT01653132|O2|Outcome|Placebo|Placebo: 1ml of preservative free sterile 0.9% saline, injected into the parotid (0.2 ml each)and submandibular ( 0.3ml each) glands of subjects
176672|NCT01653132|O1|Outcome|Incobotulinum Toxin|Incobotulinum Toxin 100 units diluted in 1 ml of sterile 0.9% saline injected in the parotid (20 units, 0.2 ml each)and submandibular (30 units, 0.3ml each) glands of subjects
176673|NCT01653132|O2|Outcome|Placebo|"Sterile, preservative free 0.9% saline, 1 ml, was used as placebo, and injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .~Placebo: Sterile, preservative free 0.9% saline, 1 ml, was used as placebo, and injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands ."
176674|NCT01653132|O1|Outcome|Incobotulinum Toxin A|"Twenty units (0.2 ml) of incobotulinum toxin A injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland for a total dose of 100 units using anatomical landmarks~Incobotulinum Toxin A: Twenty units (0.2 ml) of incobotulinum toxin A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland for a total dose of 100 units using anatomical landmarks"
176675|NCT01653132|O2|Outcome|Placebo|Placebo: 1ml of preservative free sterile 0.9% saline, injected into the parotid (0.2 ml each)and submandibular ( 0.3ml each) glands of subjects
176676|NCT01653132|O1|Outcome|Incobotulinum Toxin|Incobotulinum Toxin 100 units diluted in 1 ml of sterile 0.9% saline injected in the parotid (20 units, 0.2 ml each)and submandibular (30 units, 0.3ml each) glands of subjects
176677|NCT01653132|O2|Outcome|Incobotulinum Toxin A|Inco-A, 100 units was reconstituted with 1 ml 0.9% sterile saline (dilution: 10 units/0.1 ml). Twenty units (0.2 ml) of Inco-A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland using anatomical landmarks
176678|NCT01653132|O1|Outcome|Placebo|Sterile, preservative free 0.9% saline, 1 ml, injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .
176679|NCT01653132|O2|Outcome|Incobotulinum Toxin A|Inco-A, 100 units was reconstituted with 1 ml 0.9% sterile saline (dilution: 10 units/0.1 ml). Twenty units (0.2 ml) of Inco-A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland using anatomical landmarks
176680|NCT01653132|O1|Outcome|Placebo|Sterile, preservative free 0.9% saline, 1 ml, injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .
176681|NCT01653132|E2|Reported Event|Placebo|Sterile, preservative free 0.9% saline, 1 mL injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .
176688|NCT01653028|B1|Baseline|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176689|NCT01653028|P5|Participant Flow|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176690|NCT01653028|P4|Participant Flow|Cohort4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176691|NCT01653028|P3|Participant Flow|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176692|NCT01653028|P2|Participant Flow|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176693|NCT01653028|P1|Participant Flow|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176694|NCT01653028|O5|Outcome|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176695|NCT01653028|O4|Outcome|Cohort 4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176696|NCT01653028|O3|Outcome|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176697|NCT01653028|O2|Outcome|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176698|NCT01653028|O1|Outcome|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176699|NCT01653028|O5|Outcome|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176700|NCT01653028|O4|Outcome|Cohort 4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176701|NCT01653028|O3|Outcome|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176702|NCT01653028|O2|Outcome|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176703|NCT01653028|O1|Outcome|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176704|NCT01653028|O5|Outcome|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176705|NCT01653028|O4|Outcome|Cohort 4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176706|NCT01653028|O3|Outcome|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176707|NCT01653028|O2|Outcome|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176708|NCT01653028|O1|Outcome|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176709|NCT01653028|O5|Outcome|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176710|NCT01653028|O4|Outcome|Cohort 4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176711|NCT01653028|O3|Outcome|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176712|NCT01653028|O2|Outcome|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176713|NCT01653028|O1|Outcome|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176714|NCT01653028|E5|Reported Event|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176715|NCT01653028|E4|Reported Event|Cohort4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176716|NCT01653028|E3|Reported Event|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176717|NCT01653028|E2|Reported Event|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176718|NCT01653028|E1|Reported Event|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
176719|NCT01652885|B1|Baseline|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
176720|NCT01652885|P1|Participant Flow|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate atopic dermatitis (AD), twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
176748|NCT01652729|P3|Participant Flow|Placebo Comparator: Placebo|Placebo oral tablet once daily
176721|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
176722|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
176723|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
176724|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
176725|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
176726|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
176727|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
176728|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
176729|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
176730|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
176731|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
176732|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
176733|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
176734|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
176735|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
176736|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
176737|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
176738|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
176739|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
176740|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
176741|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
176742|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
176743|NCT01652885|E1|Reported Event|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
176744|NCT01652729|B4|Baseline|Total|Total of all reporting groups
176749|NCT01652729|P2|Participant Flow|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
176750|NCT01652729|P1|Participant Flow|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
176751|NCT01652729|O3|Outcome|Placebo Comparator: Placebo|Placebo oral tablet once daily
176752|NCT01652729|O2|Outcome|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
176753|NCT01652729|O1|Outcome|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
176754|NCT01652729|O3|Outcome|Placebo Comparator: Placebo|Placebo oral tablet once daily
176755|NCT01652729|O2|Outcome|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
176756|NCT01652729|O1|Outcome|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
176757|NCT01652729|O3|Outcome|Placebo Comparator: Placebo|Placebo oral tablet once daily
176758|NCT01652729|O2|Outcome|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
176759|NCT01652729|O1|Outcome|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
176760|NCT01652729|O3|Outcome|Placebo Comparator: Placebo|Placebo oral tablet once daily
176761|NCT01652729|O2|Outcome|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
176762|NCT01652729|O1|Outcome|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
176763|NCT01652729|O3|Outcome|Placebo Comparator: Placebo|Placebo oral tablet once daily
176764|NCT01652729|O2|Outcome|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
176765|NCT01652729|O1|Outcome|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
176766|NCT01652729|E3|Reported Event|Placebo Comparator: Placebo|Placebo oral tablet once daily
176767|NCT01652729|E2|Reported Event|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
176768|NCT01652729|E1|Reported Event|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
176769|NCT01652716|B3|Baseline|Total|Total of all reporting groups
176770|NCT01652716|B2|Baseline|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks followed by a switch to Exenatide QWS 2mg for at least 24 weeks
176771|NCT01652716|B1|Baseline|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
176772|NCT01652716|P2|Participant Flow|Active Comparator: Exenatide Twice Daily (BID)|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks followed by a switch to Exenatide QWS 2mg for at least 24 weeks
176773|NCT01652716|P1|Participant Flow|Experimental: Exenatide Once Weekly (QWS) Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
176774|NCT01652716|O2|Outcome|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks followed by a switch to Exenatide QWS 2mg for at least 24 weeks
176775|NCT01652716|O1|Outcome|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
176776|NCT01652716|O2|Outcome|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks followed by a switch to Exenatide QWS 2mg for at least 24 weeks
176777|NCT01652716|O1|Outcome|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
176778|NCT01652716|O2|Outcome|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks followed by a switch to Exenatide QWS 2mg for at least 24 weeks
176779|NCT01652716|O1|Outcome|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
176780|NCT01652716|O2|Outcome|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks followed by a switch to Exenatide QWS 2mg for at least 24 weeks
176781|NCT01652716|O1|Outcome|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
176782|NCT01652716|O2|Outcome|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks followed by a switch to Exenatide QWS 2mg for at least 24 weeks
176783|NCT01652716|O1|Outcome|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
176784|NCT01652716|E2|Reported Event|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks followed by a switch to Exenatide QWS 2mg for at least 24 weeks
176785|NCT01652716|E1|Reported Event|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
176786|NCT01652703|B7|Baseline|Total|Total of all reporting groups
176787|NCT01652703|B6|Baseline|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
176788|NCT01652703|B5|Baseline|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
176789|NCT01652703|B4|Baseline|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
176790|NCT01652703|B3|Baseline|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
176791|NCT01652703|B2|Baseline|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
176792|NCT01652703|B1|Baseline|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
176793|NCT01652703|P6|Participant Flow|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
176794|NCT01652703|P5|Participant Flow|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
176795|NCT01652703|P4|Participant Flow|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
176796|NCT01652703|P3|Participant Flow|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
176797|NCT01652703|P2|Participant Flow|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
176798|NCT01652703|P1|Participant Flow|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
176799|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
176800|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
176801|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
176802|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
176803|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
176804|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
176805|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
176806|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
176807|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
176808|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
176809|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
176810|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
176811|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
176812|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
176813|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
176814|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
176815|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
176816|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
176817|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
176818|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
176819|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
176820|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
176821|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
176822|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
176823|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
176824|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
176825|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
176826|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
176827|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
176828|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
176829|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
176830|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
176831|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
176832|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
176833|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
176834|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
176835|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
176836|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
176837|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
176838|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
176839|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
176840|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
176841|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
176842|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
185386|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
176843|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
176844|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
176845|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
176846|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
176847|NCT01652703|E6|Reported Event|Evolocumab Q4W 420 MG|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
176848|NCT01652703|E5|Reported Event|Evolocumab Q4W 280 MG|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
176849|NCT01652703|E4|Reported Event|Evolocumab Q2W 140 MG|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
176850|NCT01652703|E3|Reported Event|Evolocumab Q2W 70 MG|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
176851|NCT01652703|E2|Reported Event|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
176852|NCT01652703|E1|Reported Event|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
176853|NCT01652690|B3|Baseline|Total|Total of all reporting groups
176854|NCT01652690|B2|Baseline|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176855|NCT01652690|B1|Baseline|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176856|NCT01652690|P2|Participant Flow|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176857|NCT01652690|P1|Participant Flow|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176858|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176859|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176860|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176861|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176862|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176863|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176864|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176865|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176866|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176867|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176868|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176869|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176870|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176871|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176872|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176873|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176874|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176875|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176876|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
185387|NCT01618942|E2|Reported Event|Female Subjects|grouped by gender
176877|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176878|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176879|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176880|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176881|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176882|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176883|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176884|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176885|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176886|NCT01652690|E2|Reported Event|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176887|NCT01652690|E1|Reported Event|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
176888|NCT01652664|B3|Baseline|Total|Total of all reporting groups
176889|NCT01652664|B2|Baseline|Timolol|1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group.
176890|NCT01652664|B1|Baseline|Travoprost|1 drop administered in each eye in the evening with Travoprost vehicle in the morning for 3 months
176891|NCT01652664|P2|Participant Flow|Timolol|1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group.
176892|NCT01652664|P1|Participant Flow|Travoprost|1 drop administered in each eye in the evening with Travoprost vehicle in the morning for 3 months
176893|NCT01652664|O2|Outcome|Timolol|1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group.
176894|NCT01652664|O1|Outcome|Travoprost|1 drop administered in each eye in the evening with Travoprost vehicle in the morning for 3 months
176895|NCT01652664|E3|Reported Event|Timolol|All participants who received timolol; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group.
176896|NCT01652664|E2|Reported Event|Travoprost|All participants who received travoprost with vehicle
176897|NCT01652664|E1|Reported Event|Pre-Treatment|All enrolled participants
176898|NCT01652573|B3|Baseline|Total|Total of all reporting groups
176899|NCT01652573|B2|Baseline|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
176900|NCT01652573|B1|Baseline|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
176901|NCT01652573|P2|Participant Flow|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
176902|NCT01652573|P1|Participant Flow|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
176903|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
176904|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
176905|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
176906|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
176907|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
176908|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
176909|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
176910|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
176911|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
176912|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
176913|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
176914|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
176915|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
176916|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
176917|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
176918|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
176919|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
176920|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
176921|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
176922|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
176923|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
176924|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
176925|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
176926|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
176927|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
176928|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
176929|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
176930|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
176931|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
176932|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
176933|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
176934|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
176935|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
176936|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
176937|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
176938|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
176939|NCT01652573|E2|Reported Event|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
176940|NCT01652573|E1|Reported Event|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
176941|NCT01652495|B3|Baseline|Total|Total of all reporting groups
176942|NCT01652495|B2|Baseline|Triamcinolone Acetonide|Single intrabursal injection of 40 mg (1 ml) of trimacinolone acetonide
176943|NCT01652495|B1|Baseline|Methylprednisolone Acetate|Single intrabursal injection of 40 mg (1 ml) of methylprednisolone acetate
176944|NCT01652495|P2|Participant Flow|Triamcinolone Acetonide Group|"Single intrabursal injection of Triamcinolone acetonide~Triamcinolone Acetonide: Single intrabursal ultrasound guided injection"
176945|NCT01652495|P1|Participant Flow|Methylprednisolone Acetate Group|"Single intrabursal injection of methylprednisolone acetate~methylprednisolone acetate: Single intrabursal ultrasound guided injection"
176946|NCT01652495|O2|Outcome|Triamcinolone Acetonide Group|"Single intrabursal injection of Triamcinolone acetonide~Triamcinolone Acetonide: Single intrabursal ultrasound guided injection of 40 mg (1 ml) of triamcinolone acetonide"
176947|NCT01652495|O1|Outcome|Methylprednisolone Acetate Group|"Single intrabursal injection of methylprednisolone acetate~methylprednisolone acetate: Single intrabursal ultrasound guided injection of 40 mg (1 ml) of methylprednisolone acetate"
176948|NCT01652495|O2|Outcome|Triamcinolone Acetonide Group|"Single intrabursal injection of Triamcinolone acetonide~Triamcinolone Acetonide: Single intrabursal ultrasound guided injection"
176949|NCT01652495|O1|Outcome|Methylprednisolone Acetate Group|"Single intrabursal injection of methylprednisolone acetate~methylprednisolone acetate: Single intrabursal ultrasound guided injection"
176950|NCT01652495|O2|Outcome|Triamcinolone Acetonide Group|"Single intrabursal injection of Triamcinolone acetonide~Triamcinolone Acetonide: Single intrabursal ultrasound guided injection"
176951|NCT01652495|O1|Outcome|Methylprednisolone Acetate Group|"Single intrabursal injection of methylprednisolone acetate~methylprednisolone acetate: Single intrabursal ultrasound guided injection"
176952|NCT01652495|E2|Reported Event|Triamcinolone Acetonide Group|"Single intrabursal injection of Triamcinolone acetonide~Triamcinolone Acetonide: Single intrabursal ultrasound guided injection"
176953|NCT01652495|E1|Reported Event|Methylprednisolone Acetate Group|"Single intrabursal injection of methylprednisolone acetate~methylprednisolone acetate: Single intrabursal ultrasound guided injection"
176954|NCT01652287|B3|Baseline|Total|Total of all reporting groups
176955|NCT01652287|B2|Baseline|Control|yogurt cultured with starter YF-L702
176956|NCT01652287|B1|Baseline|BB-12®|Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt
176957|NCT01652287|P2|Participant Flow|Control|yogurt cultured with starter YF-L702
176958|NCT01652287|P1|Participant Flow|BB-12|Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt
176959|NCT01652287|O2|Outcome|Control|yogurt cultured with starter YF-L702
176960|NCT01652287|O1|Outcome|BB-12®|Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt
176961|NCT01652287|E2|Reported Event|Control|yogurt cultured with starter YF-L702
177187|NCT01650805|O2|Outcome|Imatinib|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
176962|NCT01652287|E1|Reported Event|BB-12®|Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt
176963|NCT01652040|B3|Baseline|Total|Total of all reporting groups
176964|NCT01652040|B2|Baseline|Testosterone Replacement Patches (Tp)|"Applying Testosterone patches~Testosterone Patches: The investigators will provide Tp patches for 16 weeks for patients with Spinal Cord Injury."
176965|NCT01652040|B1|Baseline|RT+Tp|"Resistance training using electrical stimulation and ankle weights and Testosterone patches~Resistance Training and Testosterone Patches: We are going to activate the knee extensor muscle group to lift ankle weights over 16 weeks and we are going to provide Tp to improve anabolic profile."
176966|NCT01652040|P2|Participant Flow|Testosterone Replacement Patches (Tp)|"Applying Testosterone patches~Testosterone Patches: The investigators will provide Tp patches for 16 weeks for patients with Spinal Cord Injury."
176967|NCT01652040|P1|Participant Flow|RT+Tp|"Resistance training using electrical stimulation and ankle weights and Testosterone patches~Resistance Training and Testosterone Patches: We are going to activate the knee extensor muscle group to lift ankle weights over 16 weeks and we are going to provide Tp to improve anabolic profile."
176968|NCT01652040|O2|Outcome|Testosterone Replacement Patches (Tp)|"Applying Testosterone patches~Testosterone Patches: The investigators will provide Tp patches for 16 weeks for patients with Spinal Cord Injury."
176969|NCT01652040|O1|Outcome|RT+Tp|"Resistance training using electrical stimulation and ankle weights and Testosterone patches~Resistance Training and Testosterone Patches: We are going to activate the knee extensor muscle group to lift ankle weights over 16 weeks and we are going to provide Tp to improve anabolic profile."
176970|NCT01652040|O2|Outcome|Testosteroe Replacement Patches (Tp)|"Applying Testosterone patches~Testosterone Patches: The investigators will provide Tp patches for 16 weeks for patients with Spinal Cord Injury."
176971|NCT01652040|O1|Outcome|RT+Tp|"Resistance training using electrical stimulation and ankle weights and Testosterone patches~Resistance Training and Testosterone Patches: We are going to activate the knee extensor muscle group to lift ankle weights over 16 weeks and we are going to provide Tp to improve anabolic profile."
176972|NCT01652040|E2|Reported Event|Testosterone Replacement Patches (Tp)|"Applying Testosterone patches~Testosterone Patches: The investigators will provide Tp patches for 16 weeks for patients with Spinal Cord Injury."
176973|NCT01652040|E1|Reported Event|RT+Tp|"Resistance training using electrical stimulation and ankle weights and Testosterone patches~Resistance Training and Testosterone Patches: We are going to activate the knee extensor muscle group to lift ankle weights over 16 weeks and we are going to provide Tp to improve anabolic profile."
176974|NCT01652001|B3|Baseline|Total|Total of all reporting groups
176975|NCT01652001|B2|Baseline|Control|"Control group was given a placebo with opaque flask(without any brand name)labeled B and with the same presentation and composition than Experimental group (excepting 1% malic acid).~Placebo: Oral spray for application into the oral cavity"
176976|NCT01652001|B1|Baseline|Malic Acid 1%|"Intervention group subjects was the delivery to the patients of a topical sialogogue, containing 1% malic acid, xylitol 10% and fluoride 0.05%(Xeros Dentaid Spray©, Dentaid, Barcelona, Spain).~Spray was transferred by foreign personnel into identical opaque flasks(without any brand name)labeled A.~Malic Acid: Oral spray for application into the oral cavity"
176977|NCT01652001|P2|Participant Flow|Control|"Control group was given a placebo with opaque flask(without any brand name)labeled B and with the same presentation and composition than Experimental group (excepting 1% malic acid).~Placebo: Oral spray for application into the oral cavity"
176978|NCT01652001|P1|Participant Flow|Malic Acid 1%|"Intervention group subjects was the delivery to the patients of a topical sialogogue, containing 1% malic acid, xylitol 10% and fluoride 0.05%(Xeros Dentaid Spray©, Dentaid, Barcelona, Spain).~Spray was transferred by foreign personnel into identical opaque flasks(without any brand name)labeled A.~Malic Acid: Oral spray for application into the oral cavity"
176979|NCT01652001|O2|Outcome|Control|"Control group was given a placebo with opaque flask(without any brand name)labeled B and with the same presentation and composition than Experimental group (excepting 1% malic acid).~Placebo: Oral spray for application into the oral cavity"
176980|NCT01652001|O1|Outcome|Malic Acid 1%|"Intervention group subjects was the delivery to the patients of a topical sialogogue, containing 1% malic acid, xylitol 10% and fluoride 0.05%(Xeros Dentaid Spray©, Dentaid, Barcelona, Spain).~Spray was transferred by foreign personnel into identical opaque flasks(without any brand name)labeled A.~Malic Acid: Oral spray for application into the oral cavity"
176981|NCT01652001|O2|Outcome|Control|"Control group was given a placebo with opaque flask(without any brand name)labeled B and with the same presentation and composition than Experimental group (excepting 1% malic acid).~Placebo: Oral spray for application into the oral cavity"
176982|NCT01652001|O1|Outcome|Malic Acid 1%|"Intervention group subjects was the delivery to the patients of a topical sialogogue, containing 1% malic acid, xylitol 10% and fluoride 0.05%(Xeros Dentaid Spray©, Dentaid, Barcelona, Spain).~Spray was transferred by foreign personnel into identical opaque flasks(without any brand name)labeled A.~Malic Acid: Oral spray for application into the oral cavity"
176983|NCT01652001|E2|Reported Event|Control|Patients treated with a placebo
176984|NCT01652001|E1|Reported Event|Malic Acid 1%|Patients treated with Malic Acid 1%
176985|NCT01651949|B4|Baseline|Total|Total of all reporting groups
176986|NCT01651949|B3|Baseline|Men Who Have Sex With Men (MSM)|Healthy MSM 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
176987|NCT01651949|B2|Baseline|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
176988|NCT01651949|B1|Baseline|Heterosexual Males|Healthy heterosexual males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
176989|NCT01651949|P3|Participant Flow|Men Who Have Sex With Men (MSM)|Healthy MSM 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
176990|NCT01651949|P2|Participant Flow|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
176991|NCT01651949|P1|Participant Flow|Heterosexual Males|Healthy heterosexual males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
176992|NCT01651949|O2|Outcome|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
176993|NCT01651949|O1|Outcome|Heterosexual and MSM Males|Healthy heterosexual and MSM males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
176994|NCT01651949|O2|Outcome|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
176995|NCT01651949|O1|Outcome|Heterosexual and MSM Males|Healthy heterosexual and MSM males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
176996|NCT01651949|O3|Outcome|Men Who Have Sex With Men|Healthy MSM 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
176997|NCT01651949|O2|Outcome|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
176998|NCT01651949|O1|Outcome|Heterosexual Males|Healthy heterosexual males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
176999|NCT01651949|O2|Outcome|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
177000|NCT01651949|O1|Outcome|Heterosexual and MSM Males|Healthy heterosexual and MSM males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
177001|NCT01651949|O2|Outcome|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
177002|NCT01651949|O1|Outcome|Heterosexual and MSM Males|Healthy heterosexual and MSM males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
177003|NCT01651949|O3|Outcome|Men Who Have Sex With Men|Healthy MSM 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
177004|NCT01651949|O2|Outcome|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
177005|NCT01651949|O1|Outcome|Heterosexual Males|Healthy heterosexual males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
177006|NCT01651949|E2|Reported Event|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
177007|NCT01651949|E1|Reported Event|Heterosexual and MSM Males|Healthy heterosexual and MSM males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
177008|NCT01651936|B3|Baseline|Total|Total of all reporting groups
177009|NCT01651936|B2|Baseline|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
177010|NCT01651936|B1|Baseline|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
177011|NCT01651936|P3|Participant Flow|Extension Study: MK-8457|MK-8457 100 mg BID + MTX for up to 76 weeks in the Extension Study. Participants who completed or had early escape from the Base Study were eligible to enroll in the Extension Study.
177012|NCT01651936|P2|Participant Flow|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
177013|NCT01651936|P1|Participant Flow|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
177014|NCT01651936|O2|Outcome|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
177015|NCT01651936|O1|Outcome|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
177016|NCT01651936|O2|Outcome|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
177017|NCT01651936|O1|Outcome|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
177018|NCT01651936|O2|Outcome|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
177019|NCT01651936|O1|Outcome|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
177020|NCT01651936|O2|Outcome|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
177021|NCT01651936|O1|Outcome|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
177022|NCT01651936|O2|Outcome|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
177023|NCT01651936|O1|Outcome|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
177024|NCT01651936|O2|Outcome|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
177025|NCT01651936|O1|Outcome|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
177026|NCT01651936|O2|Outcome|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
177027|NCT01651936|O1|Outcome|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
177028|NCT01651936|O2|Outcome|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
177029|NCT01651936|O1|Outcome|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
177030|NCT01651936|E3|Reported Event|Extension Study: MK-8457|MK-8457 100 mg BID + MTX for up to 76 weeks in the Extension Study. Participants who completed or had early escape from the Base Study were eligible to enroll in the Extension Study
177031|NCT01651936|E2|Reported Event|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
177032|NCT01651936|E1|Reported Event|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
177033|NCT01651806|B6|Baseline|Total|Total of all reporting groups
177034|NCT01651806|B5|Baseline|Male Weighted Dose of TA Patients|"Male Patients receiving a weighted dose of TA. Will include all patients that will get a weighted dose of the TA during surgery. Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss.~Tranexamic Acid weighted dose: Weighted dose--20mg/kg of the drug will be given"
177035|NCT01651806|B4|Baseline|Male Patients Receiving a Uniform Dose of TA|"Male Patients receiving a single dose of 1 gram of TA--includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss.~Patients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA."
177036|NCT01651806|B3|Baseline|Control|Historical cohort of primary TKAs performed by senior author, none of which received TA.
177188|NCT01650805|O1|Outcome|Ponatinib|ponatinib: 45 mg tablet, taken orally once daily
185388|NCT01618942|E1|Reported Event|Male Subjects|grouped by gender
177037|NCT01651806|B2|Baseline|Female Weighted Dose of TA Patients|"Female Patients receiving a weighted dose of TA. Will include all patients that will get a weighted dose of the TA during surgery. Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss.~Tranexamic Acid weighted dose: Weighted dose--20mg/kg of the drug will be given"
177038|NCT01651806|B1|Baseline|Female Patients Receiving a Uniform Dose of TA|"Female Patients receiving a single dose of 1 gram of TA--includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss.~Patients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA."
177039|NCT01651806|P5|Participant Flow|Male Weighted Dose TA Patient|"Male patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing"
177040|NCT01651806|P4|Participant Flow|Male Uniform Single Dose TA Patient|"Male patients receiving a single dose (1gram) of TA during TKA. Includes all male patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Uniform 1 gram dosing"
177041|NCT01651806|P3|Participant Flow|Control|"Historical cohort of primary TKAs performed by BL, none of which received TA.~A control group was established from a historical cohort of primary TKAs performed by the senior author (BL), none of which received TA. The most relevant Pubmed ID would be 24997651."
177042|NCT01651806|P2|Participant Flow|Female Weighted Dose TA Patient|"Female patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing"
177043|NCT01651806|P1|Participant Flow|Female Uniform Single Dose TA Patient|"Female patients receiving a single dose (1gram) of TA during TKA. Includes all female patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Uniform 1 gram dosing"
177044|NCT01651806|O5|Outcome|Male Weighted Dose TA|"Male patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing"
177045|NCT01651806|O4|Outcome|Male Uniform Single Dose TA|"Male patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Uniform 1 gram dosing"
177046|NCT01651806|O3|Outcome|Control|Historical cohort of primary TKAs performed by BL, none of which received TA.
177047|NCT01651806|O2|Outcome|Female Weighted Dose TA Patient|"Female patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing"
177048|NCT01651806|O1|Outcome|Female Uniform Single Dose TA Patient|"Female patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Uniform 1 gram dosing"
177049|NCT01651806|O5|Outcome|Male Weighted Dose TA Patient|"Female patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing"
177050|NCT01651806|O4|Outcome|Male Uniform Single Dose TA|"Male patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Uniform 1 gram dosing"
177051|NCT01651806|O3|Outcome|Control|Historical cohort of primary TKAs performed by BL, none of which received TA.
177052|NCT01651806|O2|Outcome|Female Weighted Dose TA Patient|"Female patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing"
177053|NCT01651806|O1|Outcome|Female Uniform Single Dose TA Patient|"Female patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Uniform 1 gram dosing"
177054|NCT01651806|E5|Reported Event|Male Weighted Dose TA|"Male patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing"
177055|NCT01651806|E4|Reported Event|Male Uniform Single Dose TA Patient|"Male patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Uniform 1 gram dosing"
177056|NCT01651806|E3|Reported Event|Control|Historical cohort of primary TKAs performed by BL, none of which received TA.
177057|NCT01651806|E2|Reported Event|Female Weighted Dose TA Patient|"Female patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing"
177058|NCT01651806|E1|Reported Event|Female Uniform Single Dose TA Patient|"Female patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.~Tranexamic Acid standard dose: Uniform 1 gram dosing"
177059|NCT01651780|B3|Baseline|Total|Total of all reporting groups
177060|NCT01651780|B2|Baseline|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177061|NCT01651780|B1|Baseline|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177062|NCT01651780|P2|Participant Flow|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An activated clotting time (ACT) target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177063|NCT01651780|P1|Participant Flow|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during transcatheter aortic valve replacement (TAVR). It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177064|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177065|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177066|NCT01651780|O4|Outcome|UFH: Second Half of Study Site's Enrolled Participants|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline. This includes the second half of the site’s enrolled participants, and only sites with more than 20 participants are included in this analysis.
177067|NCT01651780|O3|Outcome|UFH: First Half of Study Site's Enrolled Participants|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline. This includes the first half of the site’s enrolled participants, and only sites with more than 20 participants are included in this analysis.
177068|NCT01651780|O2|Outcome|Bivalirudin: Second Half of Study Site's Enrolled Participants|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline. This includes the second half of the site’s enrolled participants, and only sites with more than 20 participants are included in this analysis.
177069|NCT01651780|O1|Outcome|Bivalirudin: First Half of Study Site's Enrolled Participants|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline. This includes the first half of the site’s enrolled participants, and only sites with more than 20 participants are included in this analysis.
177070|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177071|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177072|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177073|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177189|NCT01650805|E2|Reported Event|Imatinib 400 mg|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
177074|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177075|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177076|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177077|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177078|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177079|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177080|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177081|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177082|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177083|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177084|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177085|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177086|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177087|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177088|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177089|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177090|NCT01651780|E2|Reported Event|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177091|NCT01651780|E1|Reported Event|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
177092|NCT01651351|B3|Baseline|Total|Total of all reporting groups
177190|NCT01650805|E1|Reported Event|Ponatinib 45 mg|ponatinib: 45 mg tablet, taken orally once daily
177093|NCT01651351|B2|Baseline|Cohort 2|"Day 1:~GLASSIA at 0.2 mL/kg/min~Placebo at 0.04 mL/kg/min~Day 15:~GLASSIA at 0.04 mL/kg/min~Placebo at 0.2 mL/kg/min~Placebo: Human albumin 2.5%: Intravenous administration"
177094|NCT01651351|B1|Baseline|Cohort 1|"Day 1:~GLASSIA at 0.04 mL/kg/min~Placebo at 0.2 mL/kg/min~Day 15:~GLASSIA at 0.2 mL/kg/min~Placebo at 0.04 mL/kg/min~Placebo: Human albumin 2.5%: Intravenous administration"
177095|NCT01651351|P2|Participant Flow|Cohort 2|"Day 1:~GLASSIA at 0.2 mL/kg/min~Placebo at 0.04 mL/kg/min~Day 15:~GLASSIA at 0.04 mL/kg/min~Placebo at 0.2 mL/kg/min~Alpha1-proteinase inhibitor: GLASSIA will be supplied as a sterile, non-pyrogenic, ready-to-use solution, in single dose 50 mL vials; for intravenous administration.~Placebo: Human albumin 2.5%: Intravenous administration"
177096|NCT01651351|P1|Participant Flow|Cohort 1|"Day 1:~GLASSIA at 0.04 mL/kg/min~Placebo at 0.2 mL/kg/min~Day 15:~GLASSIA at 0.2 mL/kg/min~Placebo at 0.04 mL/kg/min~Alpha1-proteinase inhibitor: GLASSIA will be supplied as a sterile, non-pyrogenic, ready-to-use solution, in single dose 50 mL vials; for intravenous administration.~Placebo: Human albumin 2.5%: Intravenous administration"
177097|NCT01651351|O1|Outcome|All Study Participants|
177098|NCT01651351|O2|Outcome|GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min|
177099|NCT01651351|O1|Outcome|GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min|
177100|NCT01651351|O2|Outcome|GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min|
177101|NCT01651351|O1|Outcome|GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min|
177102|NCT01651351|O2|Outcome|GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min|
177103|NCT01651351|O1|Outcome|GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min|
177104|NCT01651351|O2|Outcome|GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min|
177105|NCT01651351|O1|Outcome|GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min|
177106|NCT01651351|O2|Outcome|GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min|
177107|NCT01651351|O1|Outcome|GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min|
177108|NCT01651351|O2|Outcome|GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min|
177109|NCT01651351|O1|Outcome|GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min|
177110|NCT01651351|E2|Reported Event|GLASSIA Infusion Rate- 0.2 mL/kg/Min|"Participants who received simultaneous infusions of:~GLASSIA at 0.2 mL/kg/min~Placebo at 0.04 mL/kg/min"
177111|NCT01651351|E1|Reported Event|GLASSIA Infusion Rate- 0.04 mL/kg/Min|"Participants who received simultaneous infusions of:~GLASSIA at 0.04 mL/kg/min~Placebo at 0.2 mL/kg/min"
177112|NCT01651260|B1|Baseline|Hollister ET Tube Securement Device|Hollister endotracheal tube securement device: Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
177113|NCT01651260|P1|Participant Flow|Hollister ET Tube Securement Device|Hollister endotracheal tube securement device : Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
177114|NCT01651260|O1|Outcome|Hollister ET Tube Securement Device|Hollister endotracheal tube securement device : Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
177115|NCT01651260|O1|Outcome|Hollister Endotracheal (ET) Tube Securement Device|Hollister endotracheal tube securement device : Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
177116|NCT01651260|E1|Reported Event|Hollister ET Tube Securement Device|Hollister endotracheal tube securement device: Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
177117|NCT01651208|B3|Baseline|Total|Total of all reporting groups
177118|NCT01651208|B2|Baseline|Mailed DVD|A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
177119|NCT01651208|B1|Baseline|Motivational Interviewing (MINT)|The MINT intervention will consist of quarterly telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. .MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Contentedness, Self-Efficacy theory, and the Stages of Change model.
177120|NCT01651208|P2|Participant Flow|Mailed DVD|A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
177121|NCT01651208|P1|Participant Flow|Motivational Interviewing (MINT)|The MINT intervention consists of quarterly telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. Each call would last approximately 30 minutes. .MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Centeredness, Self-Efficacy theory, and the Stages of Change model.
177122|NCT01651208|O2|Outcome|Mailed DVD|A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
177123|NCT01651208|O1|Outcome|Motivational Interviewing (MINT)|"The MINT intervention will consist of 4 to 7 telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. All subjects in the MINT arm will be contacted every 3 months to complete 4 encounters.MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Centeredness, Self-Efficacy theory, and the Stages of Change model.~Motivational Interviewing (MINT): Each telephone encounter will have a patient centered approach having the following basic structure"
186440|NCT01613417|O3|Outcome|Reader 3|Paired exams reviewed by Reader 3
177124|NCT01651208|O2|Outcome|Mailed DVD|A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
177125|NCT01651208|O1|Outcome|Motivational Interviewing (MINT)|The MINT intervention consists of quarterly telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. Each call would last approximately 30 minutes. .MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Centeredness, Self-Efficacy theory, and the Stages of Change model.
177126|NCT01651208|E2|Reported Event|Mailed DVD|A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
177127|NCT01651208|E1|Reported Event|Motivational Interviewing (MINT)|"The MINT intervention will consist of 4 to 7 telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. All subjects in the MINT arm will be contacted every 3 months to complete 4 encounters.MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Centeredness, Self-Efficacy theory, and the Stages of Change model.~Motivational Interviewing (MINT): Each telephone encounter will have a patient centered approach having the following basic structure"
177128|NCT01651104|B1|Baseline|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
177129|NCT01651104|P1|Participant Flow|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
177130|NCT01651104|O1|Outcome|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
177131|NCT01651104|O1|Outcome|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
177132|NCT01651104|O1|Outcome|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
177133|NCT01651104|O1|Outcome|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
177134|NCT01651104|E1|Reported Event|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
177135|NCT01651039|B1|Baseline|Panobinostat, Lenalidomide and Dexamethasone|"All patients will receive oral panobinostat, lenalidomide and dexamethasone as per protocol.~Panobinostat, Lenalidomide and Dexamethasone: Each cycle is 28 days. Panobinostat will be given 20 mg: Days 1,3,5,15,17,19. Lenalidomide will be given 25 mg: Days 1-21. Dexamethasone will be given for patients 75 years old and younger a dose of 40 mg on Days 1, 8 and 15. Dexamethasone will be given for patients older than 75 years old, 20 mg on Days 1, 8 and 15."
177136|NCT01651039|P1|Participant Flow|Panobinostat, Lenalidomide and Dexamethasone|"All patients will receive oral panobinostat, lenalidomide and dexamethasone as per protocol.~Panobinostat, Lenalidomide and Dexamethasone: Each cycle is 28 days. Panobinostat will be given 20 mg: Days 1,3,5,15,17,19. Lenalidomide will be given 25 mg: Days 1-21. Dexamethasone will be given for patients 75 years old and younger a dose of 40 mg on Days 1, 8 and 15. Dexamethasone will be given for patients older than 75 years old, 20 mg on Days 1, 8 and 15."
177137|NCT01651039|O1|Outcome|Panobinostat, Lenalidomide and Dexamethasone|All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol
177138|NCT01651039|O1|Outcome|Panobinostat, Lenalidomide and Dexamethasone|All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol
177139|NCT01651039|O1|Outcome|Panobinostat, Lenalidomide and Dexamethasone|All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol
177140|NCT01651039|O1|Outcome|Panobinostat, Lenalidomide and Dexamethasone|All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol
177141|NCT01651039|O1|Outcome|Panobinostat, Lenalidomide and Dexamethasone|All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol
177142|NCT01651039|O1|Outcome|Panobinostat, Lenalidomide and Dexamethasone|All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol
177143|NCT01651039|O1|Outcome|Panobinostat, Lenalidomide and Dexamethasone|All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol
177144|NCT01651039|O1|Outcome|Panobinostat, Lenalidomide and Dexamethasone|All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol
177145|NCT01651039|E1|Reported Event|All Subjects|Adverse events collected for all subjects who signed consent.
177146|NCT01651000|B3|Baseline|Total|Total of all reporting groups
177147|NCT01651000|B2|Baseline|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
177148|NCT01651000|B1|Baseline|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
177149|NCT01651000|P2|Participant Flow|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
177150|NCT01651000|P1|Participant Flow|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
177151|NCT01651000|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
177152|NCT01651000|O1|Outcome|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
177153|NCT01651000|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
177154|NCT01651000|O1|Outcome|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
177155|NCT01651000|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
177156|NCT01651000|O1|Outcome|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
177157|NCT01651000|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
177158|NCT01651000|O1|Outcome|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
177159|NCT01651000|E2|Reported Event|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
177160|NCT01651000|E1|Reported Event|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
177161|NCT01650844|B3|Baseline|Total|Total of all reporting groups
177162|NCT01650844|B2|Baseline|Enhanced Usual Care Group|"Children randomized to the enhanced usual care group will receive a symptom assessment using national care guidelines, a recommendation for appropriate preventive medications, and asthma education materials. We will use the web-based system to send a symptom report to the child’s PCP with guideline-based recommendations for preventive care. We will provide systematic feedback to the family and providers at the same intervals as in the SB-TEAM group’s telemedicine visits, by prompting providers to use care guidelines, and caregivers to schedule recommended follow-up visits with the PCP.~Enhanced Usual Care"
177163|NCT01650844|B1|Baseline|School-based Telemedicine Enhanced Asthma Mangement Group|"We will use a web-based system to assess asthma severity or control and will send a symptom report to the child's primary care physician (PCP). Children randomized to the SB-TEAM group, will receive a telemedicine visit in the school health office at the start of the school year to provide an initial asthma assessment. The telemedicine provider will deliver brief asthma education and referrals to community resources, and will send a guideline-based preventive medication prescription electronically to a local pharmacy. The pharmacy will deliver the medications to home and school, and the school nurse will administer the medication as directly observed therapy throughout the school year. Follow-up telemedicine assessments will occur twice during the study period. These follow-up visits will focus on assessment of control, assessment of ongoing triggers or co-morbid conditions, and brief asthma education.~School-Based Telemedicine Enhanced Asthma Management"
177164|NCT01650844|P2|Participant Flow|Enhanced Usual Care Group|"Children randomized to the enhanced usual care group will receive a symptom assessment using national care guidelines, a recommendation for appropriate preventive medications, and asthma education materials. We will use the web-based system to send a symptom report to the child’s PCP with guideline-based recommendations for preventive care. We will provide systematic feedback to the family and providers at the same intervals as in the SB-TEAM group’s telemedicine visits, by prompting providers to use care guidelines, and caregivers to schedule recommended follow-up visits with the PCP.~Enhanced Usual Care"
177191|NCT01650779|B1|Baseline|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion q2w up to Month 6.
177192|NCT01650779|P1|Participant Flow|Agalsidase Beta|Commercially available agalsidase beta (Fabrazyme ®) 1.0 milligram per kilogram (mg/kg) administered as an intravenous infusion every 2 weeks (q2w) up to Month 6.
177165|NCT01650844|P1|Participant Flow|School-based Telemedicine Enhanced Asthma Mangement Group|"We will use a web-based system to assess asthma severity or control and will send a symptom report to the child's primary care physician (PCP). Children randomized to the SB-TEAM group, will receive a telemedicine visit in the school health office at the start of the school year to provide an initial asthma assessment. The telemedicine provider will deliver brief asthma education and referrals to community resources, and will send a guideline-based preventive medication prescription electronically to a local pharmacy. The pharmacy will deliver the medications to home and school, and the school nurse will administer the medication as directly observed therapy throughout the school year. Follow-up telemedicine assessments will occur twice during the study period. These follow-up visits will focus on assessment of control, assessment of ongoing triggers or co-morbid conditions, and brief asthma education.~School-Based Telemedicine Enhanced Asthma Management"
177166|NCT01650844|O2|Outcome|Enhanced Usual Care Group|"Children randomized to the enhanced usual care group will receive a symptom assessment using national care guidelines, a recommendation for appropriate preventive medications, and asthma education materials. We will use the web-based system to send a symptom report to the child’s PCP with guideline-based recommendations for preventive care. We will provide systematic feedback to the family and providers at the same intervals as in the SB-TEAM group’s telemedicine visits, by prompting providers to use care guidelines, and caregivers to schedule recommended follow-up visits with the PCP.~Enhanced Usual Care"
177167|NCT01650844|O1|Outcome|School-based Telemedicine Enhanced Asthma Mangement Group|"We will use a web-based system to assess asthma severity or control and will send a symptom report to the child's primary care physician (PCP). Children randomized to the SB-TEAM group, will receive a telemedicine visit in the school health office at the start of the school year to provide an initial asthma assessment. The telemedicine provider will deliver brief asthma education and referrals to community resources, and will send a guideline-based preventive medication prescription electronically to a local pharmacy. The pharmacy will deliver the medications to home and school, and the school nurse will administer the medication as directly observed therapy throughout the school year. Follow-up telemedicine assessments will occur twice during the study period. These follow-up visits will focus on assessment of control, assessment of ongoing triggers or co-morbid conditions, and brief asthma education.~School-Based Telemedicine Enhanced Asthma Management"
177168|NCT01650844|E2|Reported Event|Enhanced Usual Care Group|"Children randomized to the enhanced usual care group will receive a symptom assessment using national care guidelines, a recommendation for appropriate preventive medications, and asthma education materials. We will use the web-based system to send a symptom report to the child’s PCP with guideline-based recommendations for preventive care. We will provide systematic feedback to the family and providers at the same intervals as in the SB-TEAM group’s telemedicine visits, by prompting providers to use care guidelines, and caregivers to schedule recommended follow-up visits with the PCP.~Enhanced Usual Care"
177169|NCT01650844|E1|Reported Event|School-based Telemedicine Enhanced Asthma Mangement Group|"We will use a web-based system to assess asthma severity or control and will send a symptom report to the child's primary care physician (PCP). Children randomized to the SB-TEAM group, will receive a telemedicine visit in the school health office at the start of the school year to provide an initial asthma assessment. The telemedicine provider will deliver brief asthma education and referrals to community resources, and will send a guideline-based preventive medication prescription electronically to a local pharmacy. The pharmacy will deliver the medications to home and school, and the school nurse will administer the medication as directly observed therapy throughout the school year. Follow-up telemedicine assessments will occur twice during the study period. These follow-up visits will focus on assessment of control, assessment of ongoing triggers or co-morbid conditions, and brief asthma education.~School-Based Telemedicine Enhanced Asthma Management"
177170|NCT01650831|B1|Baseline|Clinical Suspicion of Hpylori|"All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions~Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula"
177171|NCT01650831|P1|Participant Flow|Clinical Suspicion of Hpylori|"All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions~Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula"
177172|NCT01650831|O2|Outcome|Negative Modified BreathID|The amount of subjects that produced negative results for H.pylori with modified BreathID.
177173|NCT01650831|O1|Outcome|Positive Modified BreathID|The amount of subjects that produced positive results for H.pylori with modified BreathID.
177174|NCT01650831|O2|Outcome|Marketed BreathID Negative|Cleared BreathID subjects that were found to be negative for H.pylori
177175|NCT01650831|O1|Outcome|Marketed BreathID Positive|Cleared BreathID subjects that were found to be positive for H.pylori
177176|NCT01650831|O1|Outcome|Clinical Suspicion of Hpylori|"All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions~Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula"
177177|NCT01650831|E1|Reported Event|Clinical Suspicion of Hpylori|"All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions~Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula"
177178|NCT01650805|B3|Baseline|Total|Total of all reporting groups
177179|NCT01650805|B2|Baseline|Imatinib|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
177180|NCT01650805|B1|Baseline|Ponatinib|ponatinib: 45 mg tablet, taken orally once daily
177181|NCT01650805|P2|Participant Flow|Imatinib|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
177182|NCT01650805|P1|Participant Flow|Ponatinib|ponatinib: 45 mg tablet, taken orally once daily
177183|NCT01650805|O2|Outcome|Imatinib|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
177184|NCT01650805|O1|Outcome|Ponatinib|ponatinib: 45 mg tablet, taken orally once daily
177185|NCT01650805|O2|Outcome|Imatinib|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
177186|NCT01650805|O1|Outcome|Ponatinib|ponatinib: 45 mg tablet, taken orally once daily
177193|NCT01650779|O1|Outcome|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion q2w up to Month 6.
177194|NCT01650779|O1|Outcome|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion q2w up to Month 6.
177195|NCT01650779|O1|Outcome|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion q2w up to Month 6.
177196|NCT01650779|O1|Outcome|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion q2w up to Month 6.
177197|NCT01650779|E1|Reported Event|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion every 2 weeks up to Month 6.
177198|NCT01650545|B3|Baseline|Total|Total of all reporting groups
177199|NCT01650545|B2|Baseline|Conventional Oral Immune Suppression|"Arm 2) Standard immune suppression consisting of typical oral immune suppression for lung transplant recipients typically tacrolimus, mycophenolate mofetil and prednisone~standard immune suppression, oral: conventional drug"
177200|NCT01650545|B1|Baseline|Liposomal Aerosol Cyclosporine|"Arm 1) Aerosol liposomal cyclosporine Open label randomized trial using experimental inhalational therapy with liposomal aerosol cyclosporine in addition to standard immune suppression (tacrolimus , mycophenolate mofetil and prednisone) for 6 month duration at inhalational doses (5mg and 10 mg bid), to be defined by transplant type respectively (single, double lung transplant )~Liposomal aerosol cyclosporine: inhaled form of immune suppression~standard immune suppression, oral: conventional drug"
177201|NCT01650545|P2|Participant Flow|Conventional Oral Immune Suppression|"Arm 2) Standard immune suppression consisting of typical oral immune suppression for lung transplant recipients typically tacrolimus, mycophenolate mofetil and prednisone~standard immune suppression, oral: conventional drug"
177202|NCT01650545|P1|Participant Flow|Liposomal Aerosol Cyclosporine|"Arm 1) Aerosol liposomal cyclosporine Open label randomized trial using experimental inhalational therapy with liposomal aerosol cyclosporine in addition to standard immune suppression (tacrolimus , mycophenolate mofetil and prednisone) for 6 month duration at inhalational doses (5mg and 10 mg bid), to be defined by transplant type respectively (single, double lung transplant )~Liposomal aerosol cyclosporine: inhaled form of immune suppression~standard immune suppression, oral: conventional drug"
177203|NCT01650545|O2|Outcome|Conventional Oral Immune Suppression|"Arm 2) Standard immune suppression consisting of typical oral immune suppression for lung transplant recipients typically tacrolimus, mycophenolate mofetil and prednisone.~Conventrional oral immune suppression as standard of care thus consists of tacrolimus, mycophenolate mofetil prednisone rapamycin described in the subsequent section as well.~standard immune suppression, oral: conventional drug~Conventrional oral immune suppression as standard of care thus consists of tacrolimus, mycophenolate mofetil prednisone and rapamycin"
177204|NCT01650545|O1|Outcome|Liposomal Aerosol Cyclosporine|"Arm 1) Aerosol liposomal cyclosporine Open label randomized trial using experimental inhalational therapy with liposomal aerosol cyclosporine in addition to standard immune suppression (tacrolimus , mycophenolate mofetil and prednisone) for 6 month duration at inhalational doses (5mg and 10 mg bid), to be defined by transplant type respectively (single, double lung transplant )~Liposomal aerosol cyclosporine: inhaled form of immune suppression~standard immune suppression, oral: conventional drug~Conventrional oral immune suppression as standard of care thus consists of tacrolimus, mycophenolate mofetil prednisone and rapamycin"
177205|NCT01650545|O2|Outcome|Conventional Oral Immune Suppression|"Arm 2) Standard immune suppression consisting of typical oral immune suppression for lung transplant recipients typically tacrolimus, mycophenolate mofetil and prednisone~standard immune suppression, oral: conventional drug"
177206|NCT01650545|O1|Outcome|Liposomal Aerosol Cyclosporine|"Arm 1) Aerosol liposomal cyclosporine Open label randomized trial using experimental inhalational therapy with liposomal aerosol cyclosporine in addition to standard immune suppression (tacrolimus , mycophenolate mofetil and prednisone) for 6 month duration at inhalational doses (5mg and 10 mg bid), to be defined by transplant type respectively (single, double lung transplant )~Liposomal aerosol cyclosporine: inhaled form of immune suppression~standard immune suppression, oral: conventional drug"
177207|NCT01650545|O2|Outcome|Conventional Oral Immune Suppression|"Arm 2) Standard immune suppression consisting of typical oral immune suppression for lung transplant recipients typically tacrolimus, mycophenolate mofetil and prednisone~standard immune suppression, oral: conventional drug"
177208|NCT01650545|O1|Outcome|Liposomal Aerosol Cyclosporine|"Arm 1) Aerosol liposomal cyclosporine Open label randomized trial using experimental inhalational therapy with liposomal aerosol cyclosporine in addition to standard immune suppression (tacrolimus , mycophenolate mofetil and prednisone) for 6 month duration at inhalational doses (5mg and 10 mg bid), to be defined by transplant type respectively (single, double lung transplant )~Liposomal aerosol cyclosporine: inhaled form of immune suppression~standard immune suppression, oral: conventional drug"
177209|NCT01650545|E2|Reported Event|Conventional Oral Immune Suppression|"Arm 2) Standard immune suppression consisting of typical oral immune suppression for lung transplant recipients typically tacrolimus, mycophenolate mofetil and prednisone~standard immune suppression, oral: conventional drug"
177210|NCT01650545|E1|Reported Event|Liposomal Aerosol Cyclosporine|"Arm 1) Aerosol liposomal cyclosporine Open label randomized trial using experimental inhalational therapy with liposomal aerosol cyclosporine in addition to standard immune suppression (tacrolimus , mycophenolate mofetil and prednisone) for 6 month duration at inhalational doses (5mg and 10 mg bid), to be defined by transplant type respectively (single, double lung transplant )~Liposomal aerosol cyclosporine: inhaled form of immune suppression~standard immune suppression, oral: conventional drug"
177211|NCT01650519|B3|Baseline|Total|Total of all reporting groups
177212|NCT01650519|B2|Baseline|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
177213|NCT01650519|B1|Baseline|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
177281|NCT01650246|P1|Participant Flow|Lesinurad 400 mg|lesinurad 400 mg once daily (qd)
177214|NCT01650519|P2|Participant Flow|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
177215|NCT01650519|P1|Participant Flow|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
177216|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
177217|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
177218|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
177219|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
177220|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
177221|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
177222|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
177223|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
177224|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
177225|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
177226|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
177227|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
177228|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
177229|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
177230|NCT01650519|E2|Reported Event|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
177282|NCT01650246|O1|Outcome|Lesinurad 400 mg|lesinurad 400 mg once daily (qd)
177283|NCT01650246|O1|Outcome|Lesinurad 400 mg|lesinurad 400 mg once daily (qd)
177231|NCT01650519|E1|Reported Event|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
177232|NCT01650350|B1|Baseline|Low Dose Naltrexone|"LDN, 5 mg/day-(1 cycle = 28 days).~Naltrexone"
177233|NCT01650350|P1|Participant Flow|Low Dose Naltrexone|"LDN, 5 mg/day-(1 cycle = 28 days).~Naltrexone"
177234|NCT01650350|O2|Outcome|Prostate Cancer- Low Dose Naltrexone|"LDN, 5 mg/day-(1 cycle = 28 days).~Naltrexone"
177235|NCT01650350|O1|Outcome|Melanoma: Low Dose Naltrexone|"LDN, 5 mg/day-(1 cycle = 28 days).~Naltrexone"
177236|NCT01650350|E1|Reported Event|Low Dose Naltrexone|"LDN, 5 mg/day-(1 cycle = 28 days).~Naltrexone"
177237|NCT01650324|B6|Baseline|Total|Total of all reporting groups
177238|NCT01650324|B5|Baseline|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
177239|NCT01650324|B4|Baseline|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
177240|NCT01650324|B3|Baseline|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
177241|NCT01650324|B2|Baseline|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
177242|NCT01650324|B1|Baseline|Placebo|Participants received either a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg, or 600 mg
177243|NCT01650324|P5|Participant Flow|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
177244|NCT01650324|P4|Participant Flow|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
177245|NCT01650324|P3|Participant Flow|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
177246|NCT01650324|P2|Participant Flow|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
177247|NCT01650324|P1|Participant Flow|Placebo|Participants received either a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg, or 600 mg
177248|NCT01650324|O5|Outcome|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
177249|NCT01650324|O4|Outcome|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
177250|NCT01650324|O3|Outcome|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
177251|NCT01650324|O2|Outcome|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
177252|NCT01650324|O1|Outcome|Placebo|Participants received a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg or 600 mg.
177253|NCT01650324|O4|Outcome|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
177254|NCT01650324|O3|Outcome|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
177255|NCT01650324|O2|Outcome|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
177256|NCT01650324|O1|Outcome|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
177257|NCT01650324|O4|Outcome|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
177258|NCT01650324|O3|Outcome|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
177259|NCT01650324|O2|Outcome|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
177260|NCT01650324|O1|Outcome|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
177261|NCT01650324|O4|Outcome|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
177262|NCT01650324|O3|Outcome|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
177263|NCT01650324|O2|Outcome|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
177264|NCT01650324|O1|Outcome|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
177265|NCT01650324|O5|Outcome|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
177266|NCT01650324|O4|Outcome|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
177267|NCT01650324|O3|Outcome|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
177268|NCT01650324|O2|Outcome|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
177269|NCT01650324|O1|Outcome|Placebo|Participants received either a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg, or 600 mg
177270|NCT01650324|E5|Reported Event|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
177271|NCT01650324|E4|Reported Event|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
177272|NCT01650324|E3|Reported Event|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
177273|NCT01650324|E2|Reported Event|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
177274|NCT01650324|E1|Reported Event|Placebo|Participants received either a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg, or 600 mg
177275|NCT01650285|B1|Baseline|Cabazitaxel and Radiation|"Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.~Cabazitaxel: Dose Level Day 1, 22, 43~5.0 mg/m2~10.0 mg/m2~15.0 mg/m2~20.0 mg/m2"
177276|NCT01650285|P1|Participant Flow|Cabazitaxel and Radiation|"Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.~Cabazitaxel: Dose Level Day 1, 22, 43~5.0 mg/m2~10.0 mg/m2~15.0 mg/m2~20.0 mg/m2"
177277|NCT01650285|O1|Outcome|Cabazitaxel and Radiation|"Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.~Cabazitaxel: Dose Level Day 1, 22, 43~5.0 mg/m2~10.0 mg/m2~15.0 mg/m2~20.0 mg/m2"
177278|NCT01650285|O1|Outcome|Cabazitaxel and Radiation|"Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.~Cabazitaxel: Dose Level Day 1, 22, 43~5.0 mg/m2~10.0 mg/m2~15.0 mg/m2~20.0 mg/m2"
177279|NCT01650285|E1|Reported Event|Cabazitaxel and Radiation|"Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.~Cabazitaxel: Dose Level Day 1, 22, 43~5.0 mg/m2~10.0 mg/m2~15.0 mg/m2~20.0 mg/m2"
177280|NCT01650246|B1|Baseline|Lesinurad 400 mg|lesinurad 400 mg once daily (qd)
177286|NCT01649856|B2|Baseline|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177287|NCT01649856|B1|Baseline|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177288|NCT01649856|P2|Participant Flow|Rituximab Intravenous (IV)|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177289|NCT01649856|P1|Participant Flow|Rituximab Subcutaneous (SC)|Participants with previously untreated, cluster of differentiation (CD) 20-positive diffuse large B-cell lymphoma (DLBCL) received up to 8 cycles of rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 milligrams per meter-squared (mg/m^2) via IV infusion; subsequent doses were given as 1400 milligrams (mg) via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved complete response (CR) or complete response unconfirmed (CRu) after 4 cycles, but all participants received a full 8 cycles of rituximab.
177290|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177291|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177292|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177293|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177294|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177295|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177340|NCT01649609|B2|Baseline|mTOR Substitution Arm|Those in the mTOR substitution arm experienced replacement of the calcineurin inhibitor (i.e. tacrolimus) with the mTOR agent, Sirolimus for a level of 6-10 μg/L coupled with reduction of the antimetabolite dose to 50% of the dose at the time of detection of the viremia (once BK viremia PCR >5000 copies/mL).
179091|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
177296|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177297|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177298|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177299|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177300|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177301|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177302|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177303|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177304|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177305|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177306|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
179092|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
177307|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177308|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177309|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177310|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177311|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177312|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177313|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177314|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177315|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177316|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177317|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177318|NCT01649856|E2|Reported Event|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177319|NCT01649856|E1|Reported Event|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
177320|NCT01649804|B1|Baseline|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
177321|NCT01649804|P1|Participant Flow|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 milligram/kilogram (mg/kg) intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
177322|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
177323|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
177324|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
177325|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
177326|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
177327|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
177328|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
177329|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
177330|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
177331|NCT01649804|E1|Reported Event|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
177332|NCT01649791|B1|Baseline|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given orally~laboratory biomarker analysis: Correlative study~lymph node biopsy: Correlative study~bone marrow aspiration: Correlative study~pharmacological study: Correlative study~flow cytometry: Correlative study"
177333|NCT01649791|P1|Participant Flow|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given orally~laboratory biomarker analysis: Correlative study~lymph node biopsy: Correlative study~bone marrow aspiration: Correlative study~pharmacological study: Correlative study~flow cytometry: Correlative study"
177334|NCT01649791|O1|Outcome|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given orally~laboratory biomarker analysis: Correlative study~lymph node biopsy: Correlative study~bone marrow aspiration: Correlative study~pharmacological study: Correlative study~flow cytometry: Correlative study"
177335|NCT01649791|O1|Outcome|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given orally~laboratory biomarker analysis: Correlative study~lymph node biopsy: Correlative study~bone marrow aspiration: Correlative study~pharmacological study: Correlative study~flow cytometry: Correlative study"
177336|NCT01649791|O1|Outcome|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given orally~laboratory biomarker analysis: Correlative study~lymph node biopsy: Correlative study~bone marrow aspiration: Correlative study~pharmacological study: Correlative study~flow cytometry: Correlative study"
177337|NCT01649791|O1|Outcome|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given orally~laboratory biomarker analysis: Correlative study~lymph node biopsy: Correlative study~bone marrow aspiration: Correlative study~pharmacological study: Correlative study~flow cytometry: Correlative study"
177338|NCT01649791|E1|Reported Event|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given orally~laboratory biomarker analysis: Correlative study~lymph node biopsy: Correlative study~bone marrow aspiration: Correlative study~pharmacological study: Correlative study~flow cytometry: Correlative study"
177339|NCT01649609|B3|Baseline|Total|Total of all reporting groups
177408|NCT01649505|E2|Reported Event|Arm II (Standard Electrocoagulation)|Patients undergo standard electrocoagulation dissection technique.
177341|NCT01649609|B1|Baseline|Standard Immunosuppression Reduction Arm|Those in the standard immunosuppression reduction arm experienced a reduction of the calcineurin inhibitor (i.e. tacrolimus) dosage to a goal level of 4-8 μg/L and reduction of the antimetabolite agent (mycophenolic acid/mycophenolate mofetil) to 50% of dose at the time of detection of viremia (once BK viremia PCR >5000 copies/mL).
177342|NCT01649609|P2|Participant Flow|mTOR Substitution Arm|Those in the mTOR substitution arm experienced replacement of the calcineurin inhibitor (i.e. tacrolimus) with the mTOR agent, Sirolimus for a level of 6-10 μg/L coupled with reduction of the antimetabolite dose to 50% of the dose at the time of detection of the viremia (once BK viremia PCR >5000 copies/mL).
177343|NCT01649609|P1|Participant Flow|Standard Immunosuppression Reduction Arm|Those in the standard immunosuppression reduction arm experienced a reduction of the calcineurin inhibitor (i.e. tacrolimus) dosage to a goal level of 4-8 μg/L and reduction of the antimetabolite agent (mycophenolic acid/mycophenolate mofetil) to 50% of dose at the time of detection of viremia (once BK viremia PCR >5000 copies/mL).
177344|NCT01649609|O2|Outcome|mTOR Substitution Arm|Those in the mTOR substitution arm experienced replacement of the calcineurin inhibitor (i.e. tacrolimus) with the mTOR agent, Sirolimus for a level of 6-10 μg/L coupled with reduction of the antimetabolite dose to 50% of the dose at the time of detection of the viremia (once BK viremia PCR >5000 copies/mL).
177345|NCT01649609|O1|Outcome|Standard Immunosuppression Reduction Arm|Those in the standard immunosuppression reduction arm experienced a reduction of the calcineurin inhibitor (i.e. tacrolimus) dosage to a goal level of 4-8 μg/L and reduction of the antimetabolite agent (mycophenolic acid/mycophenolate mofetil) to 50% of dose at the time of detection of viremia (once BK viremia PCR >5000 copies/mL).
177346|NCT01649609|O2|Outcome|mTOR Substitution Arm|Those in the mTOR substitution arm experienced replacement of the calcineurin inhibitor (i.e. tacrolimus) with the mTOR agent, Sirolimus for a level of 6-10 μg/L coupled with reduction of the antimetabolite dose to 50% of the dose at the time of detection of the viremia (once BK viremia PCR >5000 copies/mL).
177347|NCT01649609|O1|Outcome|Standard Immunosuppression Reduction Arm|Those in the standard immunosuppression reduction arm experienced a reduction of the calcineurin inhibitor (i.e. tacrolimus) dosage to a goal level of 4-8 μg/L and reduction of the antimetabolite agent (mycophenolic acid/mycophenolate mofetil) to 50% of dose at the time of detection of viremia (once BK viremia PCR >5000 copies/mL).
177348|NCT01649609|E2|Reported Event|mTOR Substitution Arm|Those in the mTOR substitution arm experienced replacement of the calcineurin inhibitor (i.e. tacrolimus) with the mTOR agent, Sirolimus for a level of 6-10 μg/L coupled with reduction of the antimetabolite dose to 50% of the dose at the time of detection of the viremia (once BK viremia PCR >5000 copies/mL).
177349|NCT01649609|E1|Reported Event|Standard Immunosuppression Reduction Arm|Those in the standard immunosuppression reduction arm experienced a reduction of the calcineurin inhibitor (i.e. tacrolimus) dosage to a goal level of 4-8 μg/L and reduction of the antimetabolite agent (mycophenolic acid/mycophenolate mofetil) to 50% of dose at the time of detection of viremia (once BK viremia PCR >5000 copies/mL).
177350|NCT01649596|B3|Baseline|Total|Total of all reporting groups
177351|NCT01649596|B2|Baseline|Control|"Standard of care, warm blankets~Standard of care - warm blankets"
177352|NCT01649596|B1|Baseline|3M Bair Paws Flex Gown|"3M Bair Paws Flex Warming Gown and 3M Bair Paws Model 875 Warming Unit~3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer"
177353|NCT01649596|P2|Participant Flow|Control|Standard of care warm blankets
177354|NCT01649596|P1|Participant Flow|3M Bair Paws Flex Gown|"3M Bair Paws Flex Warming Gown and 3M Bair Paws Model 875 Warming Unit~3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer"
177355|NCT01649596|O2|Outcome|Control|Standard of care warm blankets
177356|NCT01649596|O1|Outcome|3M Bair Paws Flex Gown|"3M Bair Paws Flex Warming Gown and 3M Bair Paws Model 875 Warming Unit~3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer"
177357|NCT01649596|O2|Outcome|Control|Standard of care warm blankets
177358|NCT01649596|O1|Outcome|3M Bair Paws Flex Gown|"3M Bair Paws Flex Warming Gown and 3M Bair Paws Model 875 Warming Unit~3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer"
177359|NCT01649596|E2|Reported Event|Control|Standard of care warm blankets
177360|NCT01649596|E1|Reported Event|3M Bair Paws Flex Gown|"3M Bair Paws Flex Warming Gown and 3M Bair Paws Model 875 Warming Unit~3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer"
177361|NCT01649557|B4|Baseline|Total|Total of all reporting groups
177362|NCT01649557|B3|Baseline|Prior Apripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177363|NCT01649557|B2|Baseline|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177364|NCT01649557|B1|Baseline|Prior Brexiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177365|NCT01649557|P3|Participant Flow|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177366|NCT01649557|P2|Participant Flow|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177409|NCT01649505|E1|Reported Event|Arm I (Fibrin Sealant)|Patients undergo sharp dissection technique with fibrin sealant closure.
177410|NCT01649362|B3|Baseline|Total|Total of all reporting groups
177411|NCT01649362|B2|Baseline|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
177367|NCT01649557|P1|Participant Flow|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177368|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177369|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177370|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177371|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177372|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177373|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177374|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177375|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177376|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177377|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177378|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177379|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177380|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177381|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177382|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177383|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177384|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177385|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177386|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177387|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177388|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177389|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177390|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177391|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177392|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177393|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177394|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177395|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177396|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177397|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177398|NCT01649557|E3|Reported Event|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177399|NCT01649557|E2|Reported Event|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177400|NCT01649557|E1|Reported Event|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
177401|NCT01649505|B3|Baseline|Total|Total of all reporting groups
177402|NCT01649505|B2|Baseline|Arm II (Standard Electrocoagulation)|"Patients undergo standard electrocoagulation dissection technique.~breast reconstruction : Undergo electrocoagulation dissection technique"
177403|NCT01649505|B1|Baseline|Arm I (Fibrin Sealant)|"Patients undergo sharp dissection technique with fibrin sealant closure.~breast reconstruction : Undergo sharp dissection technique~fibrin sealant (Beriplast P, TISSEEL VH) : Applied topically"
177404|NCT01649505|P2|Participant Flow|Arm II (Standard Electrocoagulation)|"Patients undergo standard electrocoagulation dissection technique.~breast reconstruction : Undergo electrocoagulation dissection technique"
177405|NCT01649505|P1|Participant Flow|Arm I (Fibrin Sealant)|"Patients undergo sharp dissection technique with fibrin sealant closure.~breast reconstruction : Undergo sharp dissection technique~fibrin sealant (Beriplast P, TISSEEL VH) : Applied topically"
177406|NCT01649505|O2|Outcome|Arm II (Standard Electrocoagulation)|"Patients undergo standard electrocoagulation dissection technique.~breast reconstruction : Undergo electrocoagulation dissection technique"
177407|NCT01649505|O1|Outcome|Arm I (Fibrin Sealant)|"Patients undergo sharp dissection technique with fibrin sealant closure.~breast reconstruction : Undergo sharp dissection technique~fibrin sealant (Beriplast P, TISSEEL VH) : Applied topically"
177413|NCT01649362|P2|Participant Flow|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
177414|NCT01649362|P1|Participant Flow|Control Group|no prefeeding oral stimulation
177415|NCT01649362|O2|Outcome|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
177416|NCT01649362|O1|Outcome|Control Group|no prefeeding oral stimulation
177417|NCT01649362|O2|Outcome|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
177418|NCT01649362|O1|Outcome|Control Group|no prefeeding oral stimulation
177419|NCT01649362|O2|Outcome|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
177420|NCT01649362|O1|Outcome|Control Group|no prefeeding oral stimulation
177421|NCT01649362|E2|Reported Event|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
177422|NCT01649362|E1|Reported Event|Control Group|no prefeeding oral stimulation
177423|NCT01649297|B6|Baseline|Total|Total of all reporting groups
177424|NCT01649297|B5|Baseline|Placebo|Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
177425|NCT01649297|B4|Baseline|Empa 10mg QD|Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
177426|NCT01649297|B3|Baseline|Empa 5mg BID|Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
177427|NCT01649297|B2|Baseline|Empa 25mg QD|Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
177428|NCT01649297|B1|Baseline|Empa 12.5mg BID|Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
177429|NCT01649297|P5|Participant Flow|Placebo|Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
177430|NCT01649297|P4|Participant Flow|Empa 10mg QD|Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
177431|NCT01649297|P3|Participant Flow|Empa 5mg BID|Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
177432|NCT01649297|P2|Participant Flow|Empa 25mg QD|Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
177433|NCT01649297|P1|Participant Flow|Empa 12.5mg BID|Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
177434|NCT01649297|O5|Outcome|Placebo|Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
177435|NCT01649297|O4|Outcome|Empa 10mg QD|Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
177436|NCT01649297|O3|Outcome|Empa 5mg BID|Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
177437|NCT01649297|O2|Outcome|Empa 25mg QD|Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
177438|NCT01649297|O1|Outcome|Empa 12.5mg BID|Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
177439|NCT01649297|O5|Outcome|Placebo|Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
177440|NCT01649297|O4|Outcome|Empa 10mg QD|Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
177441|NCT01649297|O3|Outcome|Empa 5mg BID|Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
177442|NCT01649297|O2|Outcome|Empa 25mg QD|Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
177443|NCT01649297|O1|Outcome|Empa 12.5mg BID|Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
177444|NCT01649297|E5|Reported Event|Placebo|Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
177445|NCT01649297|E4|Reported Event|Empa 10mg QD|Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
177446|NCT01649297|E3|Reported Event|Empa 5mg BID|Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
177447|NCT01649297|E2|Reported Event|Empa 25mg QD|Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
177448|NCT01649297|E1|Reported Event|Empa 12.5mg BID|Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
177449|NCT01649271|B3|Baseline|Total|Total of all reporting groups
177450|NCT01649271|B2|Baseline|Phase Ia: Afatinib 30mg+Trastuzumab 8 mg/kg|In each 21 day treatment cycle, patients were administered orally 30 mg afatinib tablet from Day 2 continuous daily administration in combination with trastuzumab. An initial loading dose of trastuzumab 8 mg/kg was administered via intravenous infusion at Day1 Cycle1, followed by trastuzumab 6 mg/kg every 3 weeks. Trastuzumab intravenous infusion, 90 minutes, infusion duration could be reduced to 30 minutes if well tolerated.
177451|NCT01649271|B1|Baseline|Phase Ia: Afatinib 20mg+Trastuzumab 8 mg/kg|In each 21 day treatment cycle, patients were administered orally 20 mg afatinib tablet from Day 2 continuous daily administration in combination with trastuzumab. An initial loading dose of trastuzumab 8 mg/kg was administered via intravenous infusion at Day1 Cycle1, followed by trastuzumab 6 mg/kg every 3 weeks. Trastuzumab intravenous infusion, 90 minutes, infusion duration could be reduced to 30 minutes if well tolerated.
177452|NCT01649271|P2|Participant Flow|Phase Ia: Afatinib 30mg+Trastuzumab 8 mg/kg|In each 21 day treatment cycle, patients were administered orally 30 mg afatinib tablet from Day 2 continuous daily administration in combination with trastuzumab. An initial loading dose of trastuzumab 8 mg/kg was administered via intravenous infusion at Day1 Cycle1, followed by trastuzumab 6 mg/kg every 3 weeks. Trastuzumab intravenous infusion, 90 minutes, infusion duration could be reduced to 30 minutes if well tolerated.
177453|NCT01649271|P1|Participant Flow|Phase Ia: Afatinib 20mg+Trastuzumab 8 mg/kg|In each 21 day treatment cycle, patients were administered orally 20 mg afatinib tablet from Day 2 continuous daily administration in combination with trastuzumab. An initial loading dose of trastuzumab 8 mg/kg was administered via intravenous infusion at Day1 Cycle1, followed by trastuzumab 6 mg/kg every 3 weeks. Trastuzumab intravenous infusion, 90 minutes, infusion duration could be reduced to 30 minutes if well tolerated.
177454|NCT01649271|O2|Outcome|Phase Ia: Afatinib 30mg+Trastuzumab 8 mg/kg|In each 21 day treatment cycle, patients were administered orally 30 mg afatinib tablet from Day 2 continuous daily administration in combination with trastuzumab. An initial loading dose of trastuzumab 8 mg/kg was administered via intravenous infusion at Day1 Cycle1, followed by trastuzumab 6 mg/kg every 3 weeks. Trastuzumab intravenous infusion, 90 minutes, infusion duration could be reduced to 30 minutes if well tolerated.
177479|NCT01649232|O1|Outcome|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
177455|NCT01649271|O1|Outcome|Phase Ia: Afatinib 20mg+Trastuzumab 8 mg/kg|In each 21 day treatment cycle, patients were administered orally 20 mg afatinib tablet from Day 2 continuous daily administration in combination with trastuzumab. An initial loading dose of trastuzumab 8 mg/kg was administered via intravenous infusion at Day1 Cycle1, followed by trastuzumab 6 mg/kg every 3 weeks. Trastuzumab intravenous infusion, 90 minutes, infusion duration could be reduced to 30 minutes if well tolerated.
177456|NCT01649271|O2|Outcome|Phase Ia: Afatinib 30mg+Trastuzumab 8 mg/kg|In each 21 day treatment cycle, patients were administered orally 30 mg afatinib tablet from Day 2 continuous daily administration in combination with trastuzumab. An initial loading dose of trastuzumab 8 mg/kg was administered via intravenous infusion at Day1 Cycle1, followed by trastuzumab 6 mg/kg every 3 weeks. Trastuzumab intravenous infusion, 90 minutes, infusion duration could be reduced to 30 minutes if well tolerated.
177457|NCT01649271|O1|Outcome|Phase Ia: Afatinib 20mg+Trastuzumab 8 mg/kg|In each 21 day treatment cycle, patients were administered orally 20 mg afatinib tablet from Day 2 continuous daily administration in combination with trastuzumab. An initial loading dose of trastuzumab 8 mg/kg was administered via intravenous infusion at Day1 Cycle1, followed by trastuzumab 6 mg/kg every 3 weeks. Trastuzumab intravenous infusion, 90 minutes, infusion duration could be reduced to 30 minutes if well tolerated.
177458|NCT01649271|O2|Outcome|Phase Ia: Afatinib 30mg+Trastuzumab 8 mg/kg|In each 21 day treatment cycle, patients were administered orally 30 mg afatinib tablet from Day 2 continuous daily administration in combination with trastuzumab. An initial loading dose of trastuzumab 8 mg/kg was administered via intravenous infusion at Day1 Cycle1, followed by trastuzumab 6 mg/kg every 3 weeks. Trastuzumab intravenous infusion, 90 minutes, infusion duration could be reduced to 30 minutes if well tolerated.
177459|NCT01649271|O1|Outcome|Phase Ia: Afatinib 20mg+Trastuzumab 8 mg/kg|In each 21 day treatment cycle, patients were administered orally 20 mg afatinib tablet from Day 2 continuous daily administration in combination with trastuzumab. An initial loading dose of trastuzumab 8 mg/kg was administered via intravenous infusion at Day1 Cycle1, followed by trastuzumab 6 mg/kg every 3 weeks. Trastuzumab intravenous infusion, 90 minutes, infusion duration could be reduced to 30 minutes if well tolerated.
177460|NCT01649271|O2|Outcome|Phase Ia: Afatinib 30mg+Trastuzumab 8 mg/kg|In each 21 day treatment cycle, patients were administered orally 30 mg afatinib tablet from Day 2 continuous daily administration in combination with trastuzumab. An initial loading dose of trastuzumab 8 mg/kg was administered via intravenous infusion at Day1 Cycle1, followed by trastuzumab 6 mg/kg every 3 weeks. Trastuzumab intravenous infusion, 90 minutes, infusion duration could be reduced to 30 minutes if well tolerated.
177461|NCT01649271|O1|Outcome|Phase Ia: Afatinib 20mg+Trastuzumab 8 mg/kg|In each 21 day treatment cycle, patients were administered orally 20 mg afatinib tablet from Day 2 continuous daily administration in combination with trastuzumab. An initial loading dose of trastuzumab 8 mg/kg was administered via intravenous infusion at Day1 Cycle1, followed by trastuzumab 6 mg/kg every 3 weeks. Trastuzumab intravenous infusion, 90 minutes, infusion duration could be reduced to 30 minutes if well tolerated.
177462|NCT01649271|O1|Outcome|Phase Ia: Afatinib +Trastuzumab 8 mg/kg|In each 21 day treatment cycle, patients were administered orally afatinib tablet from Day 2 continuous daily administration in combination with trastuzumab. An initial loading dose of trastuzumab 8 mg/kg was administered via intravenous infusion at Day1 Cycle1, followed by trastuzumab 6 mg/kg every 3 weeks. Trastuzumab intravenous infusion, 90 minutes, infusion duration could be reduced to 30 minutes if well tolerated.
177463|NCT01649271|E2|Reported Event|Phase Ia: Afatinib 30mg+Trastuzumab 8 mg/kg|In each 21 day treatment cycle, patients were administered orally 30 mg afatinib tablet from Day 2 continuous daily administration in combination with trastuzumab. An initial loading dose of trastuzumab 8 mg/kg was administered via intravenous infusion at Day1 Cycle1, followed by trastuzumab 6 mg/kg every 3 weeks. Trastuzumab intravenous infusion, 90 minutes, infusion duration could be reduced to 30 minutes if well tolerated.
177464|NCT01649271|E1|Reported Event|Phase Ia: Afatinib 20mg+Trastuzumab 8 mg/kg|In each 21 day treatment cycle, patients were administered orally 20 mg afatinib tablet from Day 2 continuous daily administration in combination with trastuzumab. An initial loading dose of trastuzumab 8 mg/kg was administered via intravenous infusion at Day1 Cycle1, followed by trastuzumab 6 mg/kg every 3 weeks. Trastuzumab intravenous infusion, 90 minutes, infusion duration could be reduced to 30 minutes if well tolerated.
177465|NCT01649232|B3|Baseline|Total|Total of all reporting groups
177466|NCT01649232|B2|Baseline|Controls|Healthy people that not receive tDCS
177467|NCT01649232|B1|Baseline|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
177468|NCT01649232|P2|Participant Flow|Controls|Healthy people that not receive tDCS
177469|NCT01649232|P1|Participant Flow|Active tDCS|"Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days.~55 % of subjects led the anode in temporal lobe (60% right temporal lobe and 40% in left temporal lobe). 8 % of subjects led de anode in parietal lobe (80 % in left hemisphere), and the rest of subjets 37 % of them led the anodo in frontal and prefrontal lobe (55 % in right frontal lobe and 45 % in left frontal lobe)."
177470|NCT01649232|O2|Outcome|Control Group|Healthy people that not receive tDCS
177471|NCT01649232|O1|Outcome|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
177472|NCT01649232|O4|Outcome|Control Group at 3 Months|Healthy people that not receive tDCS
177473|NCT01649232|O3|Outcome|Active tDCS at 3 Months|l Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
177474|NCT01649232|O2|Outcome|Control Group|Healthy people that not receive tDCS
177475|NCT01649232|O1|Outcome|Active tDCS Group|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
177476|NCT01649232|O4|Outcome|Control Group at 3 Months|Healthy people that not receive tDCS
177477|NCT01649232|O3|Outcome|Active tDCS at 3 Months|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
177478|NCT01649232|O2|Outcome|Control Group|Healthy people that not receive tDCS
177480|NCT01649232|O4|Outcome|Controls at 3 Months|Healthy people that not receive tDCS
177481|NCT01649232|O3|Outcome|Active tDCS at 3 Months|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
177482|NCT01649232|O2|Outcome|Controls|Healthy people that not receive tDCS
177483|NCT01649232|O1|Outcome|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
177484|NCT01649232|O2|Outcome|Control Group|Healthy people that not receive tDCS
177485|NCT01649232|O1|Outcome|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
177486|NCT01649232|E2|Reported Event|Controls|Healthy people that not receive tDCS
177487|NCT01649232|E1|Reported Event|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
177488|NCT01649180|B1|Baseline|Axitinib|"Axitinib will be given orally and will continue until progression of disease.~Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
177489|NCT01649180|P1|Participant Flow|Axitinib|"Axitinib will be given orally and will continue until progression of disease.~Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
177490|NCT01649180|O1|Outcome|Axitinib|"Axitinib will be given orally and will continue until progression of disease.~Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
177491|NCT01649180|O1|Outcome|Axitinib|"Axitinib will be given orally and will continue until progression of disease.~Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
177492|NCT01649180|O1|Outcome|Axitinib|"Axitinib will be given orally and will continue until progression of disease.~Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
177493|NCT01649180|O1|Outcome|Axitinib|"Axitinib will be given orally and will continue until progression of disease.~Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
177494|NCT01649180|O1|Outcome|Axitinib|"Axitinib will be given orally and will continue until progression of disease.~Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
177495|NCT01649180|E1|Reported Event|Axitinib|"Axitinib will be given orally and will continue until progression of disease.~Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
177496|NCT01648920|B1|Baseline|FeNO|"Participants with suspected but undiagnosed asthma had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they had a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
177497|NCT01648920|P1|Participant Flow|FeNO|"Participants with suspected but undiagnosed asthma had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they had a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
177498|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
177499|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
177500|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
177501|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
177502|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
177537|NCT01648790|O1|Outcome|5 mg Prasugrel (ODT1)|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.
177503|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
177504|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
177505|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
177506|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
177507|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
177508|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
177509|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
177510|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
177511|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
177512|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
177513|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
177538|NCT01648790|O2|Outcome|5 mg Prasugrel (ODT2)|5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.
177539|NCT01648790|O1|Outcome|5 mg Prasugrel (ODT1)|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.
179093|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
177514|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
177515|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
177516|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
177517|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
177518|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
177519|NCT01648920|E1|Reported Event|FeNO|"Participants with suspected but undiagnosed asthma had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they had a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
177520|NCT01648790|B1|Baseline|All Participants|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® formulation (ODT1) or orally disintegrating tablet containing Magnasweet® formulation (ODT2) given either on top of tongue or dispersed in water administered in either the fasted or fed state. 2 mg prasugrel ODT2 given on top of tongue in the fasted state.
177521|NCT01648790|P5|Participant Flow|Sequence 5|Day 1= 5 mg test ODT2, T-Fast; Day 2= 5 mg test ODT2, W-Fast; Day 3= 5 mg test ODT2, T-Fed; Day 4= 2 mg test ODT2, T-Fast; Day 5= 5 mg ODT1, T-Fast
177522|NCT01648790|P4|Participant Flow|Sequence 4|Day 1= 5 mg test ODT2, W-Fast; Day 2= 5 mg test ODT2, T-Fed; Day 3= 2 mg test ODT2, T-Fast; Day 4= 5 mg ODT1,T-Fast; Day 5= 5 mg test ODT2, T-Fast
177523|NCT01648790|P3|Participant Flow|Sequence 3|Day 1= 5 mg test ODT2, T-Fed; Day 2= 2 mg test ODT2, T-Fast; Day 3= 5 mg ODT1, T-Fast; Day 4= 5 mg test ODT2, T-Fast; Day 5= 5 mg test ODT2, W-Fast
177524|NCT01648790|P2|Participant Flow|Sequence 2|Day 1= 2 mg test ODT2, T-Fast; Day 2= 5 mg ODT1, T-Fast; Day 3= 5 mg test ODT2, T-Fast; Day 4= 5 mg test ODT2, W-Fast; Day 5= 5 mg test ODT2, T-Fed
177525|NCT01648790|P1|Participant Flow|Sequence 1|Day 1= 5 milligrams (mg) prasugrel without Magnasweet (reference) orally disintegrating tablet (ODT1), given on top of tongue in fasted state (T-Fast); Day 2= 5 mg prasugrel with Magnasweet (test) orally disintegrating tablet (ODT2),T-Fast; Day 3= 5 mg test ODT2, given dispersed in water in fasted state (W-Fast); Day 4= 5 mg test ODT2, given on top of tongue in fed state (T-Fed); Day 5= 2 mg test ODT2, T-Fast
177526|NCT01648790|O5|Outcome|2 mg Prasugrel (ODT2)|2 mg Prasugrel as ODT2 formulation administered orally once in the fasted state.
177527|NCT01648790|O4|Outcome|5 mg Prasugrel (ODT2)-Fed|5 mg Prasugrel as ODT2 formulation administered orally once, following a standardized breakfast.
177528|NCT01648790|O3|Outcome|5 mg Prasugrel (ODT2)-Suspension|5 mg Prasugrel as ODT2 formulation dispersed in water administered once, orally as suspension, in the fasted state.
177529|NCT01648790|O2|Outcome|5 mg Prasugrel (ODT2)|5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.
177530|NCT01648790|O1|Outcome|5 mg Prasugrel (ODT1)|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.
177531|NCT01648790|O5|Outcome|2 mg Prasugrel (ODT2)|2 mg Prasugrel as ODT2 formulation administered orally once in the fasted state.
177532|NCT01648790|O4|Outcome|5 mg Prasugrel (ODT2)-Fed|5 mg Prasugrel as ODT2 formulation administered orally once, following a standardized breakfast.
177533|NCT01648790|O3|Outcome|5 mg Prasugrel (ODT2)-Suspension|5 mg Prasugrel as ODT2 formulation dispersed in water administered once, orally as suspension, in the fasted state.
177534|NCT01648790|O2|Outcome|5 mg Prasugrel (ODT2)|5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.
177535|NCT01648790|O1|Outcome|5 mg Prasugrel (ODT1)|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.
177536|NCT01648790|O2|Outcome|5 mg Prasugrel (ODT2)|5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.
177540|NCT01648790|E5|Reported Event|2 mg Prasugrel (ODT2)|2 mg Prasugrel as ODT2 formulation administered orally once in the fasted state.
177541|NCT01648790|E4|Reported Event|5 mg Prasugrel (ODT2)-Fed|5 mg Prasugrel as ODT2 formulation administered orally once, following a standardized breakfast.
177542|NCT01648790|E3|Reported Event|5 mg Prasugrel (ODT2)-Suspension|5 mg Prasugrel as ODT2 formulation dispersed in water administered once, orally as suspension, in the fasted state.
177543|NCT01648790|E2|Reported Event|5 mg Prasugrel (ODT2)|5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.
177544|NCT01648790|E1|Reported Event|5 mg Prasugrel (ODT1)|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.
177545|NCT01648699|B1|Baseline|Osmotic Release Oral System (OROS) Hydromorphone|Osmotic Release Oral System (OROS) Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 milligram (mg) oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.
177546|NCT01648699|P1|Participant Flow|Osmotic Release Oral System (OROS) Hydromorphone|Osmotic Release Oral System (OROS) Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 milligram (mg) oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.
177547|NCT01648699|O1|Outcome|OROS Hydromorphone|OROS Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.
177548|NCT01648699|O8|Outcome|OROS Hydromorphone (No Dose Indicated)|OROS Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning for 28 days, as the dose was not indicated for these participants.
177549|NCT01648699|O7|Outcome|OROS Hydromorphone 40 mg|OROS Hydromorphone was administered as 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
177550|NCT01648699|O6|Outcome|OROS Hydromorphone 32 mg|OROS Hydromorphone was administered as 32 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
177551|NCT01648699|O5|Outcome|OROS Hydromorphone 24 mg|OROS Hydromorphone was administered as 24 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
177552|NCT01648699|O4|Outcome|OROS Hydromorphone 20 mg|OROS Hydromorphone was administered as 20 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
177553|NCT01648699|O3|Outcome|OROS Hydromorphone 16 mg|OROS Hydromorphone was administered as 16 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
177554|NCT01648699|O2|Outcome|OROS Hydromorphone 12 mg|OROS Hydromorphone was administered as 12 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
177555|NCT01648699|O1|Outcome|OROS Hydromorphone 8 Milligram (mg)|OROS Hydromorphone was administered as 8 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
177556|NCT01648699|O7|Outcome|OROS Hydromorphone 40 mg|OROS Hydromorphone was administered as 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
177557|NCT01648699|O6|Outcome|OROS Hydromorphone 32 mg|OROS Hydromorphone was administered as 32 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
177558|NCT01648699|O5|Outcome|OROS Hydromorphone 24 mg|OROS Hydromorphone was administered as 24 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
177581|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
179094|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
177559|NCT01648699|O4|Outcome|OROS Hydromorphone 20 mg|OROS Hydromorphone was administered as 20 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
177560|NCT01648699|O3|Outcome|OROS Hydromorphone 16 mg|OROS Hydromorphone was administered as 16 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
177561|NCT01648699|O2|Outcome|OROS Hydromorphone 12 mg|OROS Hydromorphone was administered as 12 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
177562|NCT01648699|O1|Outcome|OROS Hydromorphone 8 Milligram (mg)|OROS Hydromorphone was administered as 8 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
177563|NCT01648699|O7|Outcome|OROS Hydromorphone 36 mg|OROS Hydromorphone was administered as 36 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
177564|NCT01648699|O6|Outcome|OROS Hydromorphone 32 mg|OROS Hydromorphone was administered as 32 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
177565|NCT01648699|O5|Outcome|OROS Hydromorphone 24 mg|OROS Hydromorphone was administered as 24 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
177566|NCT01648699|O4|Outcome|OROS Hydromorphone 20 mg|OROS Hydromorphone was administered as 20 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
177567|NCT01648699|O3|Outcome|OROS Hydromorphone 16 mg|OROS Hydromorphone was administered as 16 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
177568|NCT01648699|O2|Outcome|OROS Hydromorphone 12 mg|OROS Hydromorphone was administered as 12 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
177569|NCT01648699|O1|Outcome|OROS Hydromorphone 8 Milligram (mg)|OROS Hydromorphone was administered as 8 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
177570|NCT01648699|E1|Reported Event|OROS Hydromorphone|OROS Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.
177571|NCT01648582|B4|Baseline|Total|Total of all reporting groups
177572|NCT01648582|B3|Baseline|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177573|NCT01648582|B2|Baseline|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177574|NCT01648582|B1|Baseline|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177575|NCT01648582|P3|Participant Flow|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
177576|NCT01648582|P2|Participant Flow|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177577|NCT01648582|P1|Participant Flow|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 subcutaneous (SC) injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177578|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177579|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177580|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177980|NCT01647737|P1|Participant Flow|Green Tea Lozenge|"GTP~Green tea lozenge: 4-6 times daily"
177582|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177583|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177584|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177585|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177586|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177587|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177588|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177589|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177590|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177591|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177592|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177593|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177594|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177595|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177596|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177597|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177598|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177599|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177600|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177601|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177602|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177603|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177604|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177605|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177606|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177607|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177608|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
177609|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177610|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177611|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177612|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177613|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177614|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
177615|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177616|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177617|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177618|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177619|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177620|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
177621|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177622|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177623|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177624|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177625|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177626|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177627|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
177628|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177629|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177630|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
177631|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177632|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177633|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
177634|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177635|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177636|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and/or a sulfonylurea.
177637|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177638|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177639|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and/or a sulfonylurea.
177640|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177641|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177642|NCT01648582|E3|Reported Event|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
177643|NCT01648582|E2|Reported Event|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177644|NCT01648582|E1|Reported Event|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
177645|NCT01648530|B1|Baseline|Participants With Migraines|Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.
177646|NCT01648530|P1|Participant Flow|Participants With Migraines|Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.
177647|NCT01648530|O2|Outcome|Participants With Chronic Migraine|Participants who returned completed internet survey with Chronic Migraine defined as ≥15 headache days/month. No intervention was administered in this study.
177648|NCT01648530|O1|Outcome|Participants With Episodic Migraine|Participants who returned completed internet survey with Episodic Migraine defined as <15 headache days/month. No intervention was administered in this study.
177649|NCT01648530|O1|Outcome|Participants With Migraines|Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.
177650|NCT01648530|E1|Reported Event|Participants With Migraines|Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.
177651|NCT01648491|B1|Baseline|Stem Cell Treatment|"Muscle Biopsy and Injection of autologous stem cells~Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.~Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra."
177652|NCT01648491|P1|Participant Flow|Stem Cell Treatment|"Muscle Biopsy and Injection of autologous stem cells~Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.~Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra."
177653|NCT01648491|O1|Outcome|Stem Cell Treatment|Muscle biopsy and injection of autologous stem cells. Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core. Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the urethra.
177654|NCT01648491|O1|Outcome|Stem Cell Treatment|Muscle biopsy and injection of autologous stem cells. Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core. Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the urethra.
177655|NCT01648491|O1|Outcome|Stem Cell Treatment|"Muscle Biopsy and Injection of autologous stem cells~Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.~Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra."
177656|NCT01648491|O1|Outcome|Stem Cell Treatment|"Muscle Biopsy and Injection of autologous stem cells~Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.~Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra."
177657|NCT01648491|E1|Reported Event|Stem Cell Treatment|"Muscle Biopsy and Injection of autologous stem cells~Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.~Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra."
177658|NCT01648452|B1|Baseline|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
177659|NCT01648452|P1|Participant Flow|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
177660|NCT01648452|O1|Outcome|Untreated Control Eye|
177661|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
177662|NCT01648452|O1|Outcome|Untreated Control Eye|
177663|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
177664|NCT01648452|O1|Outcome|Untreated Control Eye|
177665|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
177666|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
177667|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
177668|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
177669|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
177670|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
177671|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
177672|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
177673|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
177674|NCT01648452|E2|Reported Event|NT-501 CNTF-releasing Implant Events > 6 Months Post-implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline. The events listed are adverse events reported after the primary outcome endpoint of 6 months post-implantation.
177675|NCT01648452|E1|Reported Event|NT-501 CNTF-releasing Implant Events ≤ 6 Months Post-implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline. The events listed reflect the primary outcome endpoint of adverse events reported within 6 months post-implantation.
177676|NCT01648348|B4|Baseline|Total|Total of all reporting groups
177677|NCT01648348|B3|Baseline|Phase II: Bev Alone (Arm II)|Active Comparator: Arm II (bevacizumab): Patients receive bevacizumab as in arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177678|NCT01648348|B2|Baseline|Phase II: Bev + TRC105 (Arm I)|Experimental: Arm I (bevacizumab and TRC105): Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and 10 mg/kg anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 and 11 of course 1 and days 1 and 8 of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177679|NCT01648348|B1|Baseline|Phase I: Bev + TRC105 (Dose 0-2)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 (as 3 mg/kg IV) and 11 (as 3/5/7 mg/kg IV) of course 1 and days 1 (as 6/8/10 mg/kg IV)and 8 (as 6/8/10 mg/kg IV) of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177680|NCT01648348|P6|Participant Flow|Phase II: Bev Alone (Arm II)|Active Comparator: Arm II (bevacizumab): Patients receive bevacizumab as in arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177681|NCT01648348|P5|Participant Flow|Phase II: Bev + TRC105 (Arm I)|Experimental: Arm I (bevacizumab and TRC105): Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and 10 mg/kg anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 and 11 of course 1 and days 1 and 8 of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177682|NCT01648348|P4|Participant Flow|Phase I: Bev + TRC105 (Dose 2, Cohort B)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 (as 3 mg/kg IV) and 11 (as 7 mg/kg IV) of course 1 and days 1 (as 10 mg/kg IV)and 8 (as 10 mg/kg IV) of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177683|NCT01648348|P3|Participant Flow|Phase I: Bev + TRC105 (Dose 2, Cohort A)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 (as 3 mg/kg IV) and 11 (as 7 mg/kg IV) of course 1 and days 1 (as 10 mg/kg IV)and 8 (as 10 mg/kg IV) of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177684|NCT01648348|P2|Participant Flow|Phase I: Bev + TRC105 (Dose 1, Cohort A)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 (as 3 mg/kg IV) and 11 (as 5 mg/kg IV) of course 1 and days 1 (as 8 mg/kg IV)and 8 (as 8 mg/kg IV) of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177685|NCT01648348|P1|Participant Flow|Phase I: Bev + TRC105 (Dose 0, Cohort A)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 (as 3 mg/kg IV) and 11 (as 3 mg/kg IV) of course 1 and days 1 (as 6 mg/kg IV)and 8 (as 6 mg/kg IV) of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177686|NCT01648348|O2|Outcome|Phase II: Bev Alone (Arm II)|Active Comparator: Arm II (bevacizumab): Patients receive bevacizumab as in arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177687|NCT01648348|O1|Outcome|Phase II: Bev + TRC105 (Arm I)|Experimental: Arm I (bevacizumab and TRC105): Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and 10 mg/kg anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 and 11 of course 1 and days 1 and 8 of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177688|NCT01648348|O2|Outcome|Phase II: Bev Alone (Arm II)|Active Comparator: Arm II (bevacizumab): Patients receive bevacizumab as in arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177689|NCT01648348|O1|Outcome|Phase II: Bev + TRC105 (Arm I)|Experimental: Arm I (bevacizumab and TRC105): Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and 10 mg/kg anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 and 11 of course 1 and days 1 and 8 of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177690|NCT01648348|O2|Outcome|Phase II: Bev Alone (Arm II)|Active Comparator: Arm II (bevacizumab): Patients receive bevacizumab as in arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177691|NCT01648348|O1|Outcome|Phase II: Bev + TRC105 (Arm I)|Experimental: Arm I (bevacizumab and TRC105): Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and 10 mg/kg anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 and 11 of course 1 and days 1 and 8 of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177692|NCT01648348|O2|Outcome|Phase II: Bev Alone (Arm II)|Active Comparator: Arm II (bevacizumab): Patients receive bevacizumab as in arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177693|NCT01648348|O1|Outcome|Phase II: Bev + TRC105 (Arm I)|Experimental: Arm I (bevacizumab and TRC105): Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and 10 mg/kg anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 and 11 of course 1 and days 1 and 8 of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177694|NCT01648348|O2|Outcome|Phase II: Bev Alone (Arm II)|Active Comparator: Arm II (bevacizumab): Patients receive bevacizumab as in arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177695|NCT01648348|O1|Outcome|Phase II: Bev + TRC105 (Arm I)|Experimental: Arm I (bevacizumab and TRC105): Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and 10 mg/kg anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 and 11 of course 1 and days 1 and 8 of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177696|NCT01648348|O2|Outcome|Phase II: Bev Alone (Arm II)|Active Comparator: Arm II (bevacizumab): Patients receive bevacizumab as in arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177697|NCT01648348|O1|Outcome|Phase II: Bev + TRC105 (Arm I)|Experimental: Arm I (bevacizumab and TRC105): Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and 10 mg/kg anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 and 11 of course 1 and days 1 and 8 of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177698|NCT01648348|O2|Outcome|Phase II: Bev Alone (Arm II)|Active Comparator: Arm II (bevacizumab): Patients receive bevacizumab as in arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177699|NCT01648348|O1|Outcome|Phase II: Bev + TRC105 (Arm I)|Experimental: Arm I (bevacizumab and TRC105): Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and 10 mg/kg anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 and 11 of course 1 and days 1 and 8 of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177700|NCT01648348|O3|Outcome|Phase I: Bev + TRC105 (Dose 2, Cohort A + B)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 (as 3 mg/kg IV) and 11 (as 7 mg/kg IV) of course 1 and days 1 (as 10 mg/kg IV)and 8 (as 10 mg/kg IV) of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177981|NCT01647737|O2|Outcome|Placebo|Xylitol lozenge 4 - 6 times daily
177982|NCT01647737|O1|Outcome|Green Tea Lozenge|"GTP~Green tea lozenge: 4-6 times daily"
179095|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
177701|NCT01648348|O2|Outcome|Phase I: Bev + TRC105 (Dose 1, Cohort A)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 (as 3 mg/kg IV) and 11 (as 5 mg/kg IV) of course 1 and days 1 (as 8 mg/kg IV)and 8 (as 8 mg/kg IV) of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177702|NCT01648348|O1|Outcome|Phase I: Bev + TRC105 (Dose 0, Cohort A)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 (as 3 mg/kg IV) and 11 (as 3 mg/kg IV) of course 1 and days 1 (as 6 mg/kg IV)and 8 (as 6 mg/kg IV) of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177703|NCT01648348|E6|Reported Event|Phase II: Bev Alone (Arm II)|Active Comparator: Arm II (bevacizumab): Patients receive bevacizumab as in arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177704|NCT01648348|E5|Reported Event|Phase II: Bev + TRC105 (Arm I)|Experimental: Arm I (bevacizumab and TRC105): Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and 10 mg/kg anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 and 11 of course 1 and days 1 and 8 of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177705|NCT01648348|E4|Reported Event|Phase I: Bev + TRC105 (Dose 2, Cohort B)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 (as 3 mg/kg IV) and 11 (as 7 mg/kg IV) of course 1 and days 1 (as 10 mg/kg IV)and 8 (as 10 mg/kg IV) of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177706|NCT01648348|E3|Reported Event|Phase I: Bev + TRC105 (Dose 2, Cohort A)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 (as 3 mg/kg IV) and 11 (as 7 mg/kg IV) of course 1 and days 1 (as 10 mg/kg IV)and 8 (as 10 mg/kg IV) of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177707|NCT01648348|E2|Reported Event|Phase I: Bev + TRC105 (Dose 1, Cohort A)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 (as 3 mg/kg IV) and 11 (as 5 mg/kg IV) of course 1 and days 1 (as 8 mg/kg IV)and 8 (as 8 mg/kg IV) of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177708|NCT01648348|E1|Reported Event|Phase I: Bev + TRC105 (Dose 0, Cohort A)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 8 (as 3 mg/kg IV) and 11 (as 3 mg/kg IV) of course 1 and days 1 (as 6 mg/kg IV)and 8 (as 6 mg/kg IV) of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
177709|NCT01648322|B5|Baseline|Total|Total of all reporting groups
177710|NCT01648322|B4|Baseline|Neulasta® (Pegfilgrastim)|"Given to subjects receiving TC or TAC chemotherapy.~Neulasta® (pegfilgrastim): Single dose injection given once per chemotherapy cycle."
177711|NCT01648322|B3|Baseline|320 µg/kg/Dose of F-627|"This dose of F-627 given to subjects receiving TC or TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
177712|NCT01648322|B2|Baseline|240 µg/kg/Dose of F-627|"This dose of F-627 given to subjects receiving TC or TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
177713|NCT01648322|B1|Baseline|80 µg/kg/Dose of F-627|"This dose of F-627 given only to subjects that are to have TC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
177714|NCT01648322|P4|Participant Flow|Neulasta® (Pegfilgrastim)|"Given to subjects receiving TC or TAC chemotherapy.~Neulasta® (pegfilgrastim): Single dose injection given once per chemotherapy cycle."
177715|NCT01648322|P3|Participant Flow|320 µg/kg/Dose of F-627|"This dose of F-627 given to subjects receiving TC or TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
177716|NCT01648322|P2|Participant Flow|240 µg/kg/Dose of F-627|"This dose of F-627 given to subjects receiving TC or TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
177717|NCT01648322|P1|Participant Flow|80 µg/kg/Dose of F-627|"This dose of F-627 given only to subjects that are to have TC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
177718|NCT01648322|O7|Outcome|Neulasta® (Pegfilgrastim) (TAC)|"Neulasta fixed dose of 6mg given to subjects receiving TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
177719|NCT01648322|O6|Outcome|320 µg/kg/Dose of F-627 (TAC)|"This dose of F-627 given to subjects receiving TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
177720|NCT01648322|O5|Outcome|240 µg/kg/Dose of F-627 (TAC)|"This dose of F-627 given to subjects receiving TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
177721|NCT01648322|O4|Outcome|Neulasta® (Pegfilgrastim) (TC)|"Neulasta fixed dose of 6mg given to subjects receiving TC or TAC chemotherapy.~Neulasta® (pegfilgrastim): Single dose injection given once per chemotherapy cycle."
177722|NCT01648322|O3|Outcome|320 µg/kg/Dose of F-627 (TC)|"This dose of F-627 given to subjects receiving TC or TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
177723|NCT01648322|O2|Outcome|240 µg/kg/Dose of F-627 (TC)|"This dose of F-627 given to subjects receiving TC or TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
177724|NCT01648322|O1|Outcome|80 µg/kg/Dose of F-627(TC)|"This dose of F-627 given only to subjects that are to have TC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
177725|NCT01648322|E4|Reported Event|Neulasta® (Pegfilgrastim)|"Neulasta fixed dose of 6mg given to subjects receiving TC or TAC chemotherapy.~Neulasta® (pegfilgrastim): Single dose injection given once per chemotherapy cycle."
177726|NCT01648322|E3|Reported Event|320 µg/kg/Dose of F-627|"This dose of F-627 given to subjects receiving TC or TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
177727|NCT01648322|E2|Reported Event|240 µg/kg/Dose of F-627|"This dose of F-627 given to subjects receiving TC or TAC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
177728|NCT01648322|E1|Reported Event|80 µg/kg/Dose of F-627|"This dose of F-627 given only to subjects that are to have TC chemotherapy.~F-627: subcutaneous injection given 1 per chemotherapy."
177729|NCT01648140|B5|Baseline|Total|Total of all reporting groups
177983|NCT01647737|E2|Reported Event|Xylitol|"4-6 times daily lozenge containing jaborandi extract, and 500 mg xylitol for 8 weeks~Xylitol: 4-6 times daily"
177730|NCT01648140|B4|Baseline|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177731|NCT01648140|B3|Baseline|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177732|NCT01648140|B2|Baseline|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177733|NCT01648140|B1|Baseline|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177734|NCT01648140|P4|Participant Flow|GSK2336805 60 mg, G4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177735|NCT01648140|P3|Participant Flow|Telaprevir, G1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177736|NCT01648140|P2|Participant Flow|GSK2336805 60 mg, G1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177737|NCT01648140|P1|Participant Flow|GSK2336805 40 mg, G1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (Pegylated Interferon Alfa-2a [PEG] + Ribavirin [RIBA]) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the extended rapid virologic response (eRVR) achievement. PEG dose was 180 micrograms (µg) once weekly subcutaneous (SC) injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kilogram [kg]) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177738|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 ug once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177739|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177740|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 ug once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177741|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177984|NCT01647737|E1|Reported Event|MighTeaFlow|"4-6 times daily lozenge containing green tea, jaborandi extracts, and 500 mg xylitol for 8 weeks~MighTeaFlow: 4-6 times daily"
177985|NCT01647711|B6|Baseline|Total|Total of all reporting groups
178111|NCT01646814|B1|Baseline|PL2200|"Investigational product, PL2200~PL2200: PL2200, containing 325 mg aspirin active ingredient"
177742|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177743|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177744|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177745|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177746|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177747|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177748|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177749|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177750|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177751|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177752|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177753|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177986|NCT01647711|B5|Baseline|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
177987|NCT01647711|B4|Baseline|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
179096|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
177754|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177755|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177756|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177757|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177758|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177759|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177760|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177761|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177762|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177763|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177764|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177765|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177988|NCT01647711|B3|Baseline|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
177989|NCT01647711|B2|Baseline|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
179097|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
177766|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177767|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177768|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177769|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177770|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177771|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177772|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177773|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177774|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177775|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177776|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177777|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177990|NCT01647711|B1|Baseline|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
177991|NCT01647711|P5|Participant Flow|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
179098|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
177778|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177779|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177780|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2 divided doses with food.
177781|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177782|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177783|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177784|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177785|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177786|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177787|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177788|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177789|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177992|NCT01647711|P4|Participant Flow|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
177993|NCT01647711|P3|Participant Flow|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
179099|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
177790|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177791|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177792|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177793|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177794|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177795|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177796|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177797|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177798|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177799|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177800|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177801|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177994|NCT01647711|P2|Participant Flow|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
177995|NCT01647711|P1|Participant Flow|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
179100|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
177802|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177803|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177804|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177805|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177806|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeksfollowed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 μg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2divided doses with food.
177807|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177808|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeksfollowed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 μg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2divided doses with food.
177809|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177810|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeksfollowed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 μg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2divided doses with food.
177811|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177812|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeksfollowed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 μg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2divided doses with food.
177813|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 ug once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken in 2 divided doses with food.
177814|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeksfollowed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 μg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2divided doses with food.
177815|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177816|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2divided doses with food.
177817|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177818|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177819|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177820|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177821|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177822|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177823|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177824|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177825|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177826|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177996|NCT01647711|O1|Outcome|Afatinib|Patients receiving oral administration of afatinib film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
177997|NCT01647711|O1|Outcome|Afatinib|Patients receiving oral administration of afatinib film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
178113|NCT01646814|P1|Participant Flow|PL2200|"Investigational product, PL2200~PL2200: PL2200, containing 325 mg aspirin active ingredient"
177827|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177828|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177829|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177830|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177831|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177832|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177833|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177834|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177835|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177836|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177837|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177838|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177998|NCT01647711|O5|Outcome|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
177999|NCT01647711|O4|Outcome|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
179101|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
177839|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177840|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177841|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177842|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177843|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177844|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177845|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177846|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177847|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177848|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177849|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177850|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
178000|NCT01647711|O3|Outcome|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
178001|NCT01647711|O2|Outcome|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
179102|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
177851|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177852|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177853|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177854|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177855|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177856|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177857|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177858|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177859|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177860|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177861|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177862|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
178002|NCT01647711|O1|Outcome|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
178003|NCT01647711|O5|Outcome|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
179103|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
177863|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177864|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177865|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177866|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177867|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177868|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177869|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177870|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177871|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177872|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177873|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177874|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
178004|NCT01647711|O4|Outcome|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
178005|NCT01647711|O3|Outcome|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
179104|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
177875|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177876|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177877|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177878|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177879|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177880|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177881|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177882|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177883|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177884|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177885|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177886|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
178006|NCT01647711|O2|Outcome|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
178007|NCT01647711|O1|Outcome|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
179105|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
177887|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177888|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177889|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177890|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177891|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177892|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177893|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177894|NCT01648140|E4|Reported Event|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177895|NCT01648140|E3|Reported Event|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177896|NCT01648140|E2|Reported Event|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
177897|NCT01648140|E1|Reported Event|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
177898|NCT01648101|B4|Baseline|Total|Total of all reporting groups
177899|NCT01648101|B3|Baseline|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
179106|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
177900|NCT01648101|B2|Baseline|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177901|NCT01648101|B1|Baseline|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177902|NCT01648101|P3|Participant Flow|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177903|NCT01648101|P2|Participant Flow|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177904|NCT01648101|P1|Participant Flow|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177905|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177906|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177907|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177908|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
178008|NCT01647711|O5|Outcome|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
178009|NCT01647711|O4|Outcome|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
177909|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177910|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177911|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177912|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177913|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177914|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177915|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177916|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177917|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
178010|NCT01647711|O3|Outcome|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
179107|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
177918|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177919|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177920|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177921|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177922|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177923|NCT01648101|O4|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177924|NCT01648101|O3|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177925|NCT01648101|O2|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177926|NCT01648101|O1|Outcome|Overall Study Arm|
177927|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
178011|NCT01647711|O2|Outcome|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
177928|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177929|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177930|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177931|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177932|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177933|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177934|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177935|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177936|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
178012|NCT01647711|O1|Outcome|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
179108|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
177937|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177938|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177939|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177940|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177941|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177942|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177943|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177944|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177945|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
178013|NCT01647711|E6|Reported Event|All Participants|All treated participants included in the study.
178112|NCT01646814|P2|Participant Flow|Aspirin Tablets|"Active comparator, 325 mg aspirin tablets~Aspirin tablets: 325 mg aspirin tablets (USP)"
177946|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177947|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177948|NCT01648101|E3|Reported Event|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177949|NCT01648101|E2|Reported Event|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177950|NCT01648101|E1|Reported Event|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
177951|NCT01647945|B5|Baseline|Total|Total of all reporting groups
177952|NCT01647945|B4|Baseline|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
177953|NCT01647945|B3|Baseline|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
177954|NCT01647945|B2|Baseline|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
177955|NCT01647945|B1|Baseline|Placebo|Placebo: placebo pill
177956|NCT01647945|P4|Participant Flow|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
177957|NCT01647945|P3|Participant Flow|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
177958|NCT01647945|P2|Participant Flow|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
177959|NCT01647945|P1|Participant Flow|Placebo|Placebo: placebo pill
177960|NCT01647945|O4|Outcome|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
177961|NCT01647945|O3|Outcome|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
177962|NCT01647945|O2|Outcome|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
177963|NCT01647945|O1|Outcome|Placebo|Placebo: placebo pill
177964|NCT01647945|O4|Outcome|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
177965|NCT01647945|O3|Outcome|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
177966|NCT01647945|O2|Outcome|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
177967|NCT01647945|O1|Outcome|Placebo|Placebo: placebo pill
177968|NCT01647945|O4|Outcome|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
177969|NCT01647945|O3|Outcome|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
177970|NCT01647945|O2|Outcome|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
177971|NCT01647945|O1|Outcome|Placebo|Placebo: placebo pill
177972|NCT01647945|E4|Reported Event|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
177973|NCT01647945|E3|Reported Event|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
177974|NCT01647945|E2|Reported Event|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
177975|NCT01647945|E1|Reported Event|Placebo|Placebo: placebo pill
177976|NCT01647737|B3|Baseline|Total|Total of all reporting groups
177977|NCT01647737|B2|Baseline|Placebo|"Xylitol~Green tea lozenge: 4-6 times daily"
177978|NCT01647737|B1|Baseline|Green Tea Lozenge|"GTP~Green tea lozenge: 4-6 times daily"
177979|NCT01647737|P2|Participant Flow|Placebo|Xylitol lozenge 4 - 6 times daily
178014|NCT01647711|E5|Reported Event|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
178015|NCT01647711|E4|Reported Event|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
178016|NCT01647711|E3|Reported Event|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
178017|NCT01647711|E2|Reported Event|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
178018|NCT01647711|E1|Reported Event|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
178019|NCT01647542|B4|Baseline|Total|Total of all reporting groups
178020|NCT01647542|B3|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
178021|NCT01647542|B2|Baseline|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
178022|NCT01647542|B1|Baseline|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
178023|NCT01647542|P3|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
178024|NCT01647542|P2|Participant Flow|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
178025|NCT01647542|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
178026|NCT01647542|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
178027|NCT01647542|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
178028|NCT01647542|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
178029|NCT01647542|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
178030|NCT01647542|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
178031|NCT01647542|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
178032|NCT01647542|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
178033|NCT01647542|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
178034|NCT01647542|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
178035|NCT01647542|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
178036|NCT01647542|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
178037|NCT01647542|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
178038|NCT01647542|E3|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
178039|NCT01647542|E2|Reported Event|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
178040|NCT01647542|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
178041|NCT01647464|B1|Baseline|Contrast Administration|Patients undergoing contrast-enhanced echo.
178042|NCT01647464|P1|Participant Flow|Contrast Administration|Patients undergoing contrast-enhanced echo.
178043|NCT01647464|O1|Outcome|Contrast Administration|Patients undergoing contrast-enhanced echo.
178044|NCT01647464|E1|Reported Event|Contrast Administration|Patients undergoing contrast-enhanced echo.
178045|NCT01647438|B3|Baseline|Total|Total of all reporting groups
178046|NCT01647438|B2|Baseline|Lifestyle Intervention|Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
178047|NCT01647438|B1|Baseline|Primary Care Referral and Print Health Education|Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
178048|NCT01647438|P2|Participant Flow|Lifestyle Intervention|Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
178049|NCT01647438|P1|Participant Flow|Primary Care Referral and Print Health Education|Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
178050|NCT01647438|O2|Outcome|Lifestyle Intervention|Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
178051|NCT01647438|O1|Outcome|Primary Care Referral and Print Health Education|Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
178052|NCT01647438|O2|Outcome|Lifestyle Intervention|Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
178053|NCT01647438|O1|Outcome|Primary Care Referral and Print Health Education|Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
178054|NCT01647438|E2|Reported Event|Lifestyle Intervention|Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
178055|NCT01647438|E1|Reported Event|Primary Care Referral and Print Health Education|Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
178056|NCT01647282|B3|Baseline|Total|Total of all reporting groups
178057|NCT01647282|B2|Baseline|Sc/RP Alone|"Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root~scaling and root planing (Sc/RP)"
178058|NCT01647282|B1|Baseline|Sc/RP With Minocycline Micropheres|"Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root. Local application of minocycline microspheres will be done after scaling and root planing (Sc/RP) has been completed~locally-applied minocycline HCl (1 mg)~scaling and root planing (Sc/RP)"
178059|NCT01647282|P2|Participant Flow|Sc/RP Alone|"Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root~scaling and root planing (Sc/RP)"
178060|NCT01647282|P1|Participant Flow|Sc/RP With Minocycline Micropheres|"Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root. Local application of minocycline microspheres will be done after scaling and root planing (Sc/RP) has been completed~locally-applied minocycline HCl (1 mg)~scaling and root planing (Sc/RP)"
178061|NCT01647282|O2|Outcome|Sc/RP Alone|"Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root~scaling and root planing (Sc/RP)"
178062|NCT01647282|O1|Outcome|Sc/RP With Minocycline Micropheres|"Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root. Local application of minocycline microspheres will be done after scaling and root planing (Sc/RP) has been completed~locally-applied minocycline HCl (1 mg)~scaling and root planing (Sc/RP)"
178063|NCT01647282|O2|Outcome|Sc/RP Alone|"Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root~scaling and root planing (Sc/RP)"
178064|NCT01647282|O1|Outcome|Sc/RP With Minocycline Micropheres|"Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root. Local application of minocycline microspheres will be done after scaling and root planing (Sc/RP) has been completed~locally-applied minocycline HCl (1 mg)~scaling and root planing (Sc/RP)"
178065|NCT01647282|E2|Reported Event|Sc/RP Alone|"Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root~scaling and root planing (Sc/RP)"
178066|NCT01647282|E1|Reported Event|Sc/RP With Minocycline Micropheres|"Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root. Local application of minocycline microspheres will be done after scaling and root planing (Sc/RP) has been completed~locally-applied minocycline HCl (1 mg)~scaling and root planing (Sc/RP)"
178067|NCT01647217|B3|Baseline|Total|Total of all reporting groups
178068|NCT01647217|B2|Baseline|Placepo Pads Contol Arm|"9 patients will be randomized into the control group and will be treated with placebo pads. They will be divided into 2 subgroups (5 / 4 patients) according to the frequency (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.~Placebo: Lid scrub once or twice per day for one month"
178069|NCT01647217|B1|Baseline|Terpinen-4-ol Treatment Arm|"8 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (3 / 5 patients) according to the treatment regimen (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.~Terpinen-4-ol: Lid scrub once or twice per day for one month."
178070|NCT01647217|P2|Participant Flow|Placepo Pads Contol Arm|"9 patients will be randomized into the control group and will be treated with placebo pads. They will be divided into 2 subgroups (5 / 4 patients) according to the frequency (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.~Placebo: Lid scrub once or twice per day for one month"
178071|NCT01647217|P1|Participant Flow|Terpinen-4-ol Treatment Arm|"8 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (3 / 5 patients) according to the treatment regimen (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.~Terpinen-4-ol: Lid scrub once or twice per day for one month."
178072|NCT01647217|O2|Outcome|Placepo Pads Contol Arm|"9 patients will be randomized into the control group and will be treated with placebo pads. They will be divided into 2 subgroups (5 / 4 patients) according to the frequency (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.~Placebo: Lid scrub once or twice per day for one month"
178073|NCT01647217|O1|Outcome|Terpinen-4-ol Treatment Arm|"8 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (3 / 5 patients) according to the treatment regimen (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.~Terpinen-4-ol: Lid scrub once or twice per day for one month."
178109|NCT01646814|B3|Baseline|Total|Total of all reporting groups
178110|NCT01646814|B2|Baseline|Aspirin Tablets|"Active comparator, 325 mg aspirin tablets~Aspirin tablets: 325 mg aspirin tablets (USP)"
186441|NCT01613417|O2|Outcome|Reader 2|Paired exams reviewed by Reader 2
178074|NCT01647217|O2|Outcome|Placepo Pads Contol Arm|"10 patients will be randomized into the control group and will be treated with placebo pads. They will be divided into 2 subgroups (5 each) according to the frequency (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.~Placebo: Lid scrub once or twice per day for one month"
178075|NCT01647217|O1|Outcome|Terpinen-4-ol Treatment Arm|"10 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (5 patients each) according to the treatment regimen (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.~Terpinen-4-ol: Lid scrub once or twice per day for one month."
178076|NCT01647217|E2|Reported Event|Placepo Pads Contol Arm|"10 patients will be randomized into the control group and will be treated with placebo pads. They will be divided into 2 subgroups (5 each) according to the frequency (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.~Placebo: Lid scrub once or twice per day for one month"
178077|NCT01647217|E1|Reported Event|Terpinen-4-ol Treatment Arm|"10 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (5 patients each) according to the treatment regimen (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.~Terpinen-4-ol: Lid scrub once or twice per day for one month."
178078|NCT01646827|B3|Baseline|Total|Total of all reporting groups
178079|NCT01646827|B2|Baseline|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
178080|NCT01646827|B1|Baseline|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
178081|NCT01646827|P2|Participant Flow|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
178082|NCT01646827|P1|Participant Flow|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
178083|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
178084|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
178085|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
178086|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
178087|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
178088|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
178089|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
178090|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
178091|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
178092|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
178093|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
178094|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
178095|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
178096|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
178097|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
178098|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
178099|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
178100|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
178101|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
178102|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
178103|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
178104|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
178105|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
178106|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
178107|NCT01646827|E2|Reported Event|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single aripiprazole IM depot (400 mg) injection in the gluteal muscle.
178108|NCT01646827|E1|Reported Event|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single aripiprazole IM depot (400 mg) injection in the deltoid muscle.
178114|NCT01646814|O2|Outcome|Aspirin Tablets|"Active comparator, 325 mg aspirin tablets~Aspirin tablets: 325 mg aspirin tablets (USP)"
178115|NCT01646814|O1|Outcome|PL2200|"Investigational product, PL2200~PL2200: PL2200, containing 325 mg aspirin active ingredient"
178116|NCT01646814|E2|Reported Event|Aspirin Tablets|"Active comparator, 325 mg aspirin tablets~Aspirin tablets: 325 mg aspirin tablets (USP)"
178117|NCT01646814|E1|Reported Event|PL2200|"Investigational product, PL2200~PL2200: PL2200, containing 325 mg aspirin active ingredient"
178118|NCT01646762|B1|Baseline|Treatment (Chemotherapy)|Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
178119|NCT01646762|P1|Participant Flow|Treatment (Chemotherapy)|Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
178120|NCT01646762|O1|Outcome|Treatment (Chemotherapy)|Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
178121|NCT01646762|O1|Outcome|Treatment (Chemotherapy)|Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
178122|NCT01646762|O1|Outcome|Treatment (Chemotherapy)|Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
178123|NCT01646762|O1|Outcome|Treatment (Chemotherapy)|Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
178124|NCT01646762|O1|Outcome|Treatment (Chemotherapy)|Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
178125|NCT01646762|O1|Outcome|Treatment (Chemotherapy)|Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
178126|NCT01646762|E1|Reported Event|Treatment (Chemotherapy)|Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
178127|NCT01646671|B4|Baseline|Total|Total of all reporting groups
178128|NCT01646671|B3|Baseline|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
178129|NCT01646671|B2|Baseline|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
178130|NCT01646671|B1|Baseline|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
178131|NCT01646671|P3|Participant Flow|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
178132|NCT01646671|P2|Participant Flow|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
178697|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178133|NCT01646671|P1|Participant Flow|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
178134|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
178135|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
178136|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
178137|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
178138|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
178139|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
178140|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
178141|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
178142|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
178143|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
178144|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
178145|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
178146|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
178147|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
178148|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
178149|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
178150|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
178151|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
178152|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
178153|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
178154|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
178155|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
178156|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
178157|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
178158|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
178159|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
178160|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
178161|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
178162|NCT01646671|E4|Reported Event|Total Participants|All participants who were treated
178163|NCT01646671|E3|Reported Event|LCZ 400 mg + Other HTN Medications|LCZ 400 mg + other HTN medications
178164|NCT01646671|E2|Reported Event|LCZ 400 mg|LCZ 400 mg
178165|NCT01646671|E1|Reported Event|LCZ 200 mg|LCZ 200 mg
178166|NCT01646398|B3|Baseline|Total|Total of all reporting groups
178167|NCT01646398|B2|Baseline|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
178168|NCT01646398|B1|Baseline|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
178169|NCT01646398|P2|Participant Flow|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
178170|NCT01646398|P1|Participant Flow|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
178171|NCT01646398|O2|Outcome|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
178172|NCT01646398|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
178173|NCT01646398|O2|Outcome|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
178174|NCT01646398|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
178175|NCT01646398|O2|Outcome|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
178176|NCT01646398|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
178177|NCT01646398|O2|Outcome|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
178178|NCT01646398|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
178179|NCT01646398|O2|Outcome|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
178180|NCT01646398|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
178181|NCT01646398|E2|Reported Event|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
178182|NCT01646398|E1|Reported Event|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
178183|NCT01646385|B3|Baseline|Total|Total of all reporting groups
178698|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178184|NCT01646385|B2|Baseline|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
178185|NCT01646385|B1|Baseline|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
178186|NCT01646385|P2|Participant Flow|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
178187|NCT01646385|P1|Participant Flow|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
178188|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
178189|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
178190|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
178191|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
178192|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
178193|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
178194|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
178195|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
178196|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
178197|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
178240|NCT01646268|O1|Outcome|Rotigotine|"Rotigotine, daily doses, treatment group~Rotigotine: Transdermal Patch~Content:~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)~For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
178198|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
178199|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
178200|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
178201|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
178202|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
178203|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
178204|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
178205|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
178206|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
178207|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
178208|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
178209|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
178210|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
178211|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
178241|NCT01646268|O2|Outcome|Placebo|"Placebo, daily doses, placebo group~Placebo Patch: Transdermal Patch~Size:~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2~Subjects randomized to placebo will receive matching placebo patches."
178212|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
178213|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
178214|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
178215|NCT01646385|E2|Reported Event|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
178216|NCT01646385|E1|Reported Event|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
178217|NCT01646320|B3|Baseline|Total|Total of all reporting groups
178218|NCT01646320|B2|Baseline|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
178219|NCT01646320|B1|Baseline|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
178220|NCT01646320|P2|Participant Flow|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
178221|NCT01646320|P1|Participant Flow|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
178222|NCT01646320|O2|Outcome|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
178223|NCT01646320|O1|Outcome|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
178224|NCT01646320|O2|Outcome|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
178225|NCT01646320|O1|Outcome|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
178226|NCT01646320|O2|Outcome|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
178227|NCT01646320|O1|Outcome|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
178228|NCT01646320|O2|Outcome|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
178229|NCT01646320|O1|Outcome|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
178230|NCT01646320|O2|Outcome|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
178231|NCT01646320|O1|Outcome|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
178232|NCT01646320|E2|Reported Event|PLA + SAXA + MET|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
178233|NCT01646320|E1|Reported Event|DAPA + SAXA + MET|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
178234|NCT01646268|B3|Baseline|Total|Total of all reporting groups
178235|NCT01646268|B2|Baseline|Placebo|"Placebo, daily doses, placebo group~Placebo Patch: Transdermal Patch~Size:~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2~Subjects randomized to placebo will receive matching placebo patches."
178236|NCT01646268|B1|Baseline|Rotigotine|"Rotigotine, daily doses, treatment group~Rotigotine: Transdermal Patch~Content:~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)~For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
178237|NCT01646268|P2|Participant Flow|Placebo|"Placebo, daily doses, placebo group~Placebo Patch: Transdermal Patch~Size:~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2~Subjects randomized to placebo will receive matching placebo patches."
178238|NCT01646268|P1|Participant Flow|Rotigotine|"Rotigotine, daily doses, treatment group~Rotigotine: Transdermal Patch~Content:~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)~For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
178239|NCT01646268|O2|Outcome|Placebo|"Placebo, daily doses, placebo group~Placebo Patch: Transdermal Patch~Size:~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2~Subjects randomized to placebo will receive matching placebo patches."
178242|NCT01646268|O1|Outcome|Rotigotine|"Rotigotine, daily doses, treatment group~Rotigotine: Transdermal Patch~Content:~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)~For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
178243|NCT01646268|O2|Outcome|Placebo|"Placebo, daily doses, placebo group~Placebo Patch: Transdermal Patch~Size:~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2~Subjects randomized to placebo will receive matching placebo patches."
178244|NCT01646268|O1|Outcome|Rotigotine|"Rotigotine, daily doses, treatment group~Rotigotine: Transdermal Patch~Content:~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)~For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
178245|NCT01646268|O2|Outcome|Placebo|"Placebo, daily doses, placebo group~Placebo Patch: Transdermal Patch~Size:~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2~Subjects randomized to placebo will receive matching placebo patches."
178246|NCT01646268|O1|Outcome|Rotigotine|"Rotigotine, daily doses, treatment group~Rotigotine: Transdermal Patch~Content:~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)~For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
178247|NCT01646268|E2|Reported Event|Placebo|"Placebo, daily doses, placebo group~Placebo Patch: Transdermal Patch~Size:~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2~Subjects randomized to placebo will receive matching placebo patches."
178248|NCT01646268|E1|Reported Event|Rotigotine|"Rotigotine, daily doses, treatment group~Rotigotine: Transdermal Patch~Content:~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)~For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
178249|NCT01646255|B3|Baseline|Total Title|
178250|NCT01646255|B2|Baseline|Rotigotine|Subjects received rotigotine in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h or matching placebo) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h was achieved. Each dose level was maintained for 1 week.
178251|NCT01646255|B1|Baseline|Placebo|Subjects randomized to placebo received matching placebo patches.
178252|NCT01646255|P2|Participant Flow|Rotigotine|Subjects received rotigotine in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h or matching placebo) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h was achieved. Each dose level was maintained for 1 week.
178253|NCT01646255|P1|Participant Flow|Placebo|Subjects randomized to placebo received matching placebo patches.
178254|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
178255|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
178256|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
178257|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
178258|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
178259|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
178260|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
178261|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
178262|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
178263|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
178264|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
178265|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
178266|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
178267|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
178268|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
178269|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
178431|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
178270|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
178271|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
178272|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
178273|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
178274|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
178275|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
178276|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
178277|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
178278|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h or matching placebo) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h was achieved. Each dose level was maintained for 1 week.
178279|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
178280|NCT01646255|E2|Reported Event|Rotigotine|"Rotigotine, daily doses, treatment Group~Subjects will receive rotigotine or placebo patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h or matching placebo) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo is achieved. A combination of patches (rotigotine or matching placebo) will be applied for subjects who require a dose > 8 mg/ 24 h. Each dose level is maintained for 1 week."
178281|NCT01646255|E1|Reported Event|Placebo|"Placebo, daily doses, placebo Group~Subjects randomized to placebo will receive matching placebo patches."
178282|NCT01646216|B3|Baseline|Total|Total of all reporting groups
178283|NCT01646216|B2|Baseline|Tied-belt Treadmill Exercise|"Tied-belt treadmill training~The treadmill is run like a typical treadmill that is seen in the gym except that this treadmill has two belts that move instead of just one. One leg goes on one belt and the other leg uses the other belt. The belt speeds are set to move at the same speed, making this treadmill training group similar to any regular treadmill."
178284|NCT01646216|B1|Baseline|Split-belt Treadmill Exercise|"Split-belt treadmill training~Split belt treadmill: A split belt treadmill is like a typical treadmill that is seen in the gym, except that this treadmill has two belts that move instead of just one. One leg goes on one belt and the other leg uses the other belt. The belt speeds can be set to move at the same speed, making this treadmill similar to any regular treadmill, but, belt speeds can also be set so that one belt moves a little faster than the other. The belts are never set at a running or jogging speed, only a self-paced walking speed regardless of whether the belts are both going the same or slightly different speeds."
178285|NCT01646216|P2|Participant Flow|Tied-belt Treadmill Exercise|"Tied-belt treadmill training~The treadmill is run like a typical treadmill that is seen in the gym except that this treadmill has two belts that move instead of just one. One leg goes on one belt and the other leg uses the other belt. The belt speeds are set to move at the same speed, making this treadmill training group similar to any regular treadmill."
178286|NCT01646216|P1|Participant Flow|Split-belt Treadmill Exercise|"Split-belt treadmill training~Split belt treadmill: A split belt treadmill is like a typical treadmill that is seen in the gym, except that this treadmill has two belts that move instead of just one. One leg goes on one belt and the other leg uses the other belt. The belt speeds can be set to move at the same speed, making this treadmill similar to any regular treadmill, but, belt speeds can also be set so that one belt moves a little faster than the other. The belts are never set at a running or jogging speed, only a self-paced walking speed regardless of whether the belts are both going the same or slightly different speeds."
178287|NCT01646216|O5|Outcome|Tied-belt Mild Disability|Subjects trained on tied belt treadmill. Subjects in the mild disability group had baseline walking speeds greater than 0.8 m/s. There was one subject in this group
178288|NCT01646216|O4|Outcome|Tied-belt, Severe Disability|Subjects trained on tied belt treadmill. Subjects in the severe disability group had baseline walking speeds less than 0.4 m/s. There were three subjects in this group.
178289|NCT01646216|O3|Outcome|Split-belt Severe Disability|Subjects trained on split belt treadmill. Subjects in the severe disability group had baseline walking speeds less than 0.4 m/s. There were two subjects in this group.
178290|NCT01646216|O2|Outcome|Split-belt, Moderate Disability|Subjects trained on split belt treadmill. Subjects in the moderate disability group had baseline walking speeds of 0.4 m/s to 0.8 m/s. There were two subjects in this group.
178291|NCT01646216|O1|Outcome|Split-belt, Mild Disability|Subjects trained on split belt treadmill. Subjects in the mild disability group had baseline walking speeds greater than 0.8 m/s. There were two subjects in this group.
178292|NCT01646216|O5|Outcome|Tied-belt Mild Disability|Subjects trained on tied belt treadmill. Subjects in the mild disability group had baseline walking speeds greater than 0.8 m/s. There was one subject in this group.
178293|NCT01646216|O4|Outcome|Tied-belt, Severe Disability|Subjects trained on tied belt treadmill. Subjects in the severe disability group had baseline walking speeds less than 0.4 m/s. There were three subjects in this group.
178294|NCT01646216|O3|Outcome|Split-belt Severe Disability|Subjects trained on split belt treadmill. Subjects in the severe disability group had baseline walking speeds less than 0.4 m/s. There were two subjects in this group.
178699|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178295|NCT01646216|O2|Outcome|Split-belt, Moderate Disability|Subjects trained on split belt treadmill. Subjects in the moderate disability group had baseline walking speeds of 0.4 m/s to 0.8 m/s. There were two subjects in this group.
178296|NCT01646216|O1|Outcome|Split-belt, Mild Disability|Subjects trained on split belt treadmill. Subjects in the mild disability group had baseline walking speeds greater than 0.8 m/s. There were two subjects in this group.
178297|NCT01646216|O5|Outcome|Tied-belt Mild Disability|Subjects trained on tied belt treadmill. Subjects in the mild disability group had baseline walking speeds greater than 0.8 m/s. There was one subject in this group.
178298|NCT01646216|O4|Outcome|Tied-belt, Severe Disability|Subjects trained on tied belt treadmill. Subjects in the severe disability group had baseline walking speeds less than 0.4 m/s. There were three subjects in this group.
178299|NCT01646216|O3|Outcome|Split-belt Severe Disability|Subjects trained on split belt treadmill. Subjects in the severe disability group had baseline walking speeds less than 0.4 m/s. There were two subjects in this group.
178300|NCT01646216|O2|Outcome|Split-belt, Moderate Disability|Subjects trained on split belt treadmill. Subjects in the moderate disability group had baseline walking speeds of 0.4 m/s to 0.8 m/s. There were two subjects in this group.
178301|NCT01646216|O1|Outcome|Split-belt, Mild Disability|Subjects trained on split belt treadmill. Subjects in the mild disability group had baseline walking speeds greater than 0.8 m/s. There were two subjects in this group.
178302|NCT01646216|E2|Reported Event|Tied-belt Treadmill Exercise|Tied-belt treadmill training The treadmill is run like a typical treadmill that is seen in the gym except that this treadmill has two belts that move instead of just one. One leg goes on one belt and the other leg uses the other belt. The belt speeds are set to move at the same speed, making this treadmill training group similar to any regular treadmill.
178303|NCT01646216|E1|Reported Event|Split-belt Treadmill Exercise|"Split-belt treadmill training~Split belt treadmill: A split belt treadmill is like a typical treadmill that is seen in the gym, except that this treadmill has two belts that move instead of just one. One leg goes on one belt and the other leg uses the other belt. The belt speeds can be set to move at the same speed, making this treadmill similar to any regular treadmill, but, belt speeds can also be set so that one belt moves a little faster than the other. The belts are never set at a running or jogging speed, only a self-paced walking speed regardless of whether the belts are both going the same or slightly different speeds."
178304|NCT01646177|B5|Baseline|Total|Total of all reporting groups
178305|NCT01646177|B4|Baseline|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
178306|NCT01646177|B3|Baseline|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8).~Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
178307|NCT01646177|B2|Baseline|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
178308|NCT01646177|B1|Baseline|Placebo|Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
178309|NCT01646177|P4|Participant Flow|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
178310|NCT01646177|P3|Participant Flow|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10.~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
178311|NCT01646177|P2|Participant Flow|50 mg Etanercept|Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12. Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
178312|NCT01646177|P1|Participant Flow|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
178313|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
178314|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
178315|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
178316|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
178317|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
178318|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
178700|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178319|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
178320|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
178321|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
178322|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
178323|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
178324|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
178325|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
178326|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
178327|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
178328|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
178329|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
178330|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
178331|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
178332|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
178333|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
178334|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
178335|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
178336|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
178337|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
178338|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
178339|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
178340|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
178341|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
178342|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
178343|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
178344|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
178345|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
178346|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
178347|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
178348|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
178349|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
178350|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
178351|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
178352|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
178353|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
178354|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
178355|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
178356|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
178357|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
178358|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
178359|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
178360|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
178361|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
178362|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
178363|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
178364|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
178365|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
178366|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
178367|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
178368|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
178369|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
178370|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
178371|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
178372|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
178373|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
178374|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
178375|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
178376|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
178377|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
178378|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
178379|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
178380|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
178381|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
178382|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
178383|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
178384|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
178385|NCT01646177|E4|Reported Event|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"Administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection Q2W until Week 12. At Week 12, arm is assigned to Dosing Regimen 2 (Q4W).~80 mg ixekizumab: Administered SC"
178386|NCT01646177|E3|Reported Event|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|"Administered by two 80 mg SC injections at Week 0, then one 80 mg SC injection Q4W until Week 264.~80 mg ixekizumab: Administered SC"
178387|NCT01646177|E2|Reported Event|50 mg Etanercept|"Administered by SC injections twice weekly starting at Week 0 up to Week 12. At Week 12, arm is assigned to Dosing Regimen 2.~50 mg etanercept: Administered SC"
178388|NCT01646177|E1|Reported Event|Placebo|"Placebo for ixekizumab administered by two SC injections at Week 0, then one SC injection per Dosing Regimen 1 (Q2W) until Week 12.~Placebo for etanercept administered by one SC injection twice weekly starting at Week 0 up to Week 12. At Week 12, arm is assigned to Dosing Regimen 2 (Q4W).~Placebo: Administered SC"
178389|NCT01646151|B1|Baseline|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
178390|NCT01646151|P1|Participant Flow|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
178391|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
178701|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178392|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
178393|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
178394|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
178395|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
178396|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
178397|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
178398|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
178399|NCT01646151|E1|Reported Event|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
178400|NCT01646138|B6|Baseline|Total|Total of all reporting groups
178401|NCT01646138|B5|Baseline|10^7 TCID 50|Participants received influenza A(H1N1) pdm09 at a dose of 10^7 TCID50 administered intranasally.
178402|NCT01646138|B4|Baseline|10^6 TCID 50|Participants received influenza A(H1N1) pdm09 at a dose of 10^6 TCID50 administered intranasally.
178403|NCT01646138|B3|Baseline|10^5 TCID 50|Participants received influenza A(H1N1) pdm09 at a dose of 10^5 TCID50 administered intranasally.
178404|NCT01646138|B2|Baseline|10^4 TCID 50|Participants received influenza A(H1N1) pdm09 at a dose of 10^4 TCID50 administered intranasally.
178405|NCT01646138|B1|Baseline|10^3 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^3 TCID50 in 1ml given intranasally.
178406|NCT01646138|P5|Participant Flow|10^7 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^7 TCID50 in 1ml given intranasally.
178407|NCT01646138|P4|Participant Flow|10^6 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^6 TCID50 in 1ml given intranasally.
178408|NCT01646138|P3|Participant Flow|10^5 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^5 TCID50 in 1ml given intranasally.
178409|NCT01646138|P2|Participant Flow|10^4 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^4 TCID50 in 1ml given intranasally.
178410|NCT01646138|P1|Participant Flow|10^3 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^3 TCID50 in 1ml given intranasally.
178411|NCT01646138|O5|Outcome|10^7 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^7 TCID50 in 1ml given intranasally.
178412|NCT01646138|O4|Outcome|10^6 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^6 TCID50 in 1ml given intranasally.
178413|NCT01646138|O3|Outcome|10^5 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^5 TCID50 in 1ml given intranasally.
178414|NCT01646138|O2|Outcome|10^4 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^4 TCID50 in 1ml given intranasally.
178415|NCT01646138|O1|Outcome|10^3 TCID 50|Participants received influenza A(H1N1) pdm09 at a dose of 10^3 TCID 50 administered intranasally.
178416|NCT01646138|E5|Reported Event|10^7 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^7 TCID50 in 1ml given intranasally.
178417|NCT01646138|E4|Reported Event|10^6 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^6 TCID50 in 1ml given intranasally.
178418|NCT01646138|E3|Reported Event|10^5 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^5 TCID50 in 1ml given intranasally.
178419|NCT01646138|E2|Reported Event|10^4 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^4 TCID50 in 1ml given intranasally.
178420|NCT01646138|E1|Reported Event|10^3 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^3 TCID50 in 1ml given intranasally.
178421|NCT01646125|B3|Baseline|Total|Total of all reporting groups
178422|NCT01646125|B2|Baseline|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
178423|NCT01646125|B1|Baseline|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
178424|NCT01646125|P2|Participant Flow|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
178425|NCT01646125|P1|Participant Flow|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
178426|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
178427|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
178428|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
178429|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
178430|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
178432|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
178433|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
178434|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
178435|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
178436|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
178437|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
178438|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
178439|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
178440|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
178441|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
178442|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
178443|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
178444|NCT01646125|E3|Reported Event|Total|Total
178445|NCT01646125|E2|Reported Event|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
178446|NCT01646125|E1|Reported Event|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
178447|NCT01646073|B3|Baseline|Total|Total of all reporting groups
178448|NCT01646073|B2|Baseline|Adalimumab Eow|Participants were started on adalimumab 40 mg every other week (eow) in Period A and continued adalimumab 40 mg eow into Period B
178449|NCT01646073|B1|Baseline|Placebo|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B
178450|NCT01646073|P2|Participant Flow|Adalimumab Eow|Participants were started on 40 mg adalimumab every other week (eow) in Period A and continued adalimumab 40 mg eow into Period B
178451|NCT01646073|P1|Participant Flow|Placebo|Participants were started on placebo in Period A and then switched to adalimumab 40 mg eow in Period B
178452|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
178453|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
178454|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
178455|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
178456|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
178457|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
178458|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
178459|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
178460|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
178461|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
178462|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
178463|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
178464|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
178465|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
178466|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
178467|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
178468|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
178469|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
178470|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
178471|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
179109|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
178472|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
178473|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
178474|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
178475|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
178476|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
178477|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
178478|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
178479|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
178480|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
178481|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
178482|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
178483|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
178484|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
178485|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
178486|NCT01646073|E3|Reported Event|Any Adalimumab|Participants that received at least one dose of adalimumab during Period A or Period B
178487|NCT01646073|E2|Reported Event|Double-blind Adalimumab Eow|Participants were started on adalimumab eow in Period A (Week 0 to Week 12)
178488|NCT01646073|E1|Reported Event|Double-blind Placebo|Participants were started on placebo in Period A (Week 0 to Week 12)
178489|NCT01646021|B3|Baseline|Total|Total of all reporting groups
178490|NCT01646021|B2|Baseline|Temsirolimus|Participants received Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
178491|NCT01646021|B1|Baseline|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4*140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
178492|NCT01646021|P2|Participant Flow|Temsirolimus|Participants received Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
178493|NCT01646021|P1|Participant Flow|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4*140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
178494|NCT01646021|O2|Outcome|Temsirolimus|Participants received Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
178495|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4*140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
178496|NCT01646021|O2|Outcome|Temsirolimus|Participants received Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
178497|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4*140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
178498|NCT01646021|O2|Outcome|Temsirolimus|Participants received Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
178499|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4*140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
178500|NCT01646021|O2|Outcome|Temsirolimus|Participants received Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
178501|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4*140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
178502|NCT01646021|O2|Outcome|Temsirolimus|Participants received Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
178503|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4*140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
178504|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4*140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
178505|NCT01646021|O2|Outcome|Temsirolimus|Participants received Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
178506|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4*140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
178540|NCT01645735|O2|Outcome|Ceftriaxone Plus Vancomycin|Ceftriaxone 2 g IV q24 plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations
178507|NCT01646021|O2|Outcome|Temsirolimus|Participants received Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
178508|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4*140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
178509|NCT01646021|O2|Outcome|Temsirolimus|Participants received Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
178510|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4*140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
178511|NCT01646021|O2|Outcome|Temsirolimus|Participants received Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
178512|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4*140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
178513|NCT01646021|O2|Outcome|Temsirolimus|Participants received Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
178514|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4*140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
178515|NCT01646021|O2|Outcome|Temsirolimus|Participants received Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
178516|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4*140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
178517|NCT01646021|O2|Outcome|Temsirolimus|Participants received Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
178518|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4*140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
178519|NCT01646021|O2|Outcome|Temsirolimus|Participants received Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
178520|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4*140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
178521|NCT01646021|O2|Outcome|Temsirolimus|Participants received Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
178522|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4*140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
178523|NCT01646021|O2|Outcome|Temsirolimus|Participants received Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
178524|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4*140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
178525|NCT01646021|O2|Outcome|Temsirolimus|Participants received Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
178526|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4*140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
178527|NCT01646021|E2|Reported Event|Temsirolimus|Participants received Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
178528|NCT01646021|E1|Reported Event|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4*140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
178529|NCT01645735|B3|Baseline|Total|Total of all reporting groups
178530|NCT01645735|B2|Baseline|Ceftriaxone Plus Vancomycin|Ceftriaxone 2g IV over 30 minutes q24h plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations
178531|NCT01645735|B1|Baseline|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
178532|NCT01645735|P2|Participant Flow|Ceftriaxone Plus Vancomycin|Ceftriaxone 2 g IV q24 plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations; treatment duration 5 to 14 days
178533|NCT01645735|P1|Participant Flow|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h; treatment duration 5 to 14 days
178534|NCT01645735|O2|Outcome|Ceftriaxone Plus Vancomycin|Ceftriaxone 2 g IV q24 plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations
178535|NCT01645735|O1|Outcome|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
178536|NCT01645735|O2|Outcome|Ceftriaxone Plus Vancomycin|Ceftriaxone 2 g IV q24 plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations
178537|NCT01645735|O1|Outcome|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
178538|NCT01645735|O2|Outcome|Ceftriaxone Plus Vancomycin|Ceftriaxone 2g IV q24 plus vancomycin 15mg/kg IV q12h initially and then dose adjusted based on trough concentrations
178539|NCT01645735|O1|Outcome|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
178542|NCT01645735|E2|Reported Event|Ceftriaxone Plus Vancomycin|Ceftriaxone 2 g IV over 30 minutes q24h plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations
178543|NCT01645735|E1|Reported Event|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
178544|NCT01645709|B3|Baseline|Total|Total of all reporting groups
178545|NCT01645709|B2|Baseline|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
178546|NCT01645709|B1|Baseline|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
178547|NCT01645709|P2|Participant Flow|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
178548|NCT01645709|P1|Participant Flow|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
178549|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
178550|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
178551|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
178552|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
178553|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
178554|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
178555|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
178556|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
178557|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
178558|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
178559|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
178560|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
178561|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
178562|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
178563|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
178564|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
178565|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
178566|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
178567|NCT01645709|E2|Reported Event|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
178568|NCT01645709|E1|Reported Event|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
178569|NCT01645280|B6|Baseline|Total|Total of all reporting groups
178570|NCT01645280|B5|Baseline|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
178571|NCT01645280|B4|Baseline|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
178572|NCT01645280|B3|Baseline|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
178573|NCT01645280|B2|Baseline|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
178574|NCT01645280|B1|Baseline|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
178575|NCT01645280|P5|Participant Flow|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
178576|NCT01645280|P4|Participant Flow|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
178577|NCT01645280|P3|Participant Flow|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
178578|NCT01645280|P2|Participant Flow|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
178579|NCT01645280|P1|Participant Flow|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
178580|NCT01645280|O5|Outcome|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
178581|NCT01645280|O4|Outcome|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
178582|NCT01645280|O3|Outcome|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
178583|NCT01645280|O2|Outcome|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
178584|NCT01645280|O1|Outcome|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
178585|NCT01645280|O5|Outcome|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
178586|NCT01645280|O4|Outcome|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
178587|NCT01645280|O3|Outcome|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
178588|NCT01645280|O2|Outcome|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
178589|NCT01645280|O1|Outcome|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
178590|NCT01645280|O5|Outcome|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
178591|NCT01645280|O4|Outcome|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
178592|NCT01645280|O3|Outcome|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
178593|NCT01645280|O2|Outcome|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
178594|NCT01645280|O1|Outcome|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
178595|NCT01645280|O5|Outcome|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
178596|NCT01645280|O4|Outcome|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
178597|NCT01645280|O3|Outcome|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
178598|NCT01645280|O2|Outcome|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
178599|NCT01645280|O1|Outcome|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
178600|NCT01645280|E6|Reported Event|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
178601|NCT01645280|E5|Reported Event|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
178602|NCT01645280|E4|Reported Event|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
178603|NCT01645280|E3|Reported Event|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
178604|NCT01645280|E2|Reported Event|Placebo (Early Escape)|Participants who early escaped at Week 16 and received ustekinumab 90 milligram (mg) subcutaneously at Week 16, 20 and 28 along with methotrexate.
178605|NCT01645280|E1|Reported Event|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
178606|NCT01645176|B1|Baseline|Hydroxychloroquine/Atorvastatin Open Label|Hydroxychloroquine/Atorvastatin: Hydroxychloroquine 200-600 mg /day Atorvastatin 40 mg/day
178607|NCT01645176|P1|Participant Flow|Hydroxychloroquine/Atorvastatin Open Label|Hydroxychloroquine/Atorvastatin: Hydroxychloroquine 200-600 mg /day Atorvastatin 40 mg/day
178608|NCT01645176|O1|Outcome|Osteoarthritis of Knee|Change in MRI synovitis
178609|NCT01645176|E1|Reported Event|Hydroxychloroquine/Atorvastatin Open Label|Hydroxychloroquine/Atorvastatin: Hydroxychloroquine 200-600 mg /day Atorvastatin 40 mg/day
178610|NCT01645111|B1|Baseline|Clevidipine|Clevidipine
178611|NCT01645111|P1|Participant Flow|Clevidipine|Clevidipine
178612|NCT01645111|O1|Outcome|Clevidipine|Clevidipine
178613|NCT01645111|E1|Reported Event|Clevidipine|Clevidipine
178614|NCT01645098|B3|Baseline|Total|Total of all reporting groups
178615|NCT01645098|B2|Baseline|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
178616|NCT01645098|B1|Baseline|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
179110|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
178617|NCT01645098|P2|Participant Flow|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
178618|NCT01645098|P1|Participant Flow|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
178619|NCT01645098|O2|Outcome|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
178620|NCT01645098|O1|Outcome|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
178621|NCT01645098|O2|Outcome|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
178622|NCT01645098|O1|Outcome|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
178623|NCT01645098|O2|Outcome|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
178624|NCT01645098|O1|Outcome|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
178625|NCT01645098|O2|Outcome|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
178626|NCT01645098|O1|Outcome|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
178627|NCT01645098|O2|Outcome|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
178628|NCT01645098|O1|Outcome|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
178629|NCT01645098|E2|Reported Event|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
178630|NCT01645098|E1|Reported Event|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
178631|NCT01645059|B1|Baseline|Disseminated Her 2+ Breast Cancer|
178632|NCT01645059|P1|Participant Flow|Disseminated Her 2+ Breast Cancer|
178633|NCT01645059|O2|Outcome|No Taxanes First Line Treatment|
178634|NCT01645059|O1|Outcome|Taxanes First Line Treatment|
178635|NCT01645059|O2|Outcome|No Taxanes First Line Treatment|
178636|NCT01645059|O1|Outcome|Taxanes First Line Treatment|
178637|NCT01645059|O2|Outcome|No Taxanes First Line Treatment|
178638|NCT01645059|O1|Outcome|Taxanes First Line Treatment|
178639|NCT01645059|O2|Outcome|No Trastuzumab Adjuvant Treatment|
178640|NCT01645059|O1|Outcome|Trastuzumab Adjuvant Treatment|
178641|NCT01645059|O2|Outcome|No Trastuzumab Adjuvant Treatment|
178642|NCT01645059|O1|Outcome|Trastuzumab Adjuvant Treatment|
178643|NCT01645059|O2|Outcome|No Trastuzumab Adjuvant Treatment|
178644|NCT01645059|O1|Outcome|Trastuzumab Adjuvant Treatment|
178645|NCT01645059|O1|Outcome|Disseminated HER 2 + Breast Cancer|
178646|NCT01645059|O1|Outcome|Disseminated Her 2+ Breast Cancer|
178647|NCT01645059|O1|Outcome|Disseminated Her 2+ Breast Cancer|
178648|NCT01645059|E1|Reported Event|Disseminated Her 2+ Breast Cancer|
178649|NCT01644734|B1|Baseline|Patients Treated With Spiriva HandiHaler|Inhalator is administered once daily in the dosage of 18µg.
178650|NCT01644734|P1|Participant Flow|Patients Treated With Spiriva HandiHaler|Inhalator is administered once daily in the dosage of 18µg.
178651|NCT01644734|O1|Outcome|Patients Treated With Spiriva HandiHaler|Inhalator is administered once daily in the dosage of 18µg.
178652|NCT01644734|O1|Outcome|Patients Treated With Spiriva HandiHaler|Inhalator is administered once daily in the dosage of 18µg.
178653|NCT01644734|E1|Reported Event|Patients Treated With Spiriva HandiHaler|Inhalator is administered once daily in the dosage of 18µg.
178654|NCT01644695|B1|Baseline|Candidate for BARS Procedure.|"The subjects selected for this trial were over 18 years of age with an appropriate complex, incisional hernia. These patients were consented and treated with the BARS(bony anchoring reinforcement system)procedure.~Bony Anchoring Reinforcement System : Abdominal exposure was obtained via a lower horizontal incision, a vertical incision, or through a combination horizontal/vertical (ie fleur-di-lis) pattern. Exploratory laparotomy, lysis of intra-abdominal adhesions with hernia sac excision was performed prior to fascial closure. Primary closure of the abdominal fascia was performed with a combination of components separation and placement of biologic mesh over the fascial incision line in onlay fashion. Typically three bone anchors were used to secure the synthetic mesh at the pubic symphysis and two bone anchors to the ASIS bilaterally. The superior aspect of the marlex mesh was sutured to fascia avoiding any incorporation of the costal perichondrium. Quilting sutures were used to"
178702|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178703|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178655|NCT01644695|P1|Participant Flow|Candidate for BARS Procedure.|"The subjects selected for this trial were over 18 years of age with an appropriate complex, incisional hernia. These patients were consented and treated with the BARS(bony anchoring reinforcement system)procedure.~Bony Anchoring Reinforcement System : Abdominal exposure was obtained via a lower horizontal incision, a vertical incision, or through a combination horizontal/vertical (ie fleur-di-lis) pattern. Exploratory laparotomy, lysis of intra-abdominal adhesions with hernia sac excision was performed prior to fascial closure. Primary closure of the abdominal fascia was performed with a combination of components separation and placement of biologic mesh over the fascial incision line in onlay fashion. Typically three bone anchors were used to secure the synthetic mesh at the pubic symphysis and two bone anchors to the ASIS bilaterally. The superior aspect of the marlex mesh was sutured to fascia avoiding any incorporation of the costal perichondrium. Quilting sutures were used to"
178656|NCT01644695|O1|Outcome|Candidate for BARS Procedure.|"The subjects selected for this trial were over 18 years of age with an appropriate complex, incisional hernia. These patients were consented and treated with the BARS(bony anchoring reinforcement system)procedure.~Bony Anchoring Reinforcement System : Abdominal exposure was obtained via a lower horizontal incision, a vertical incision, or through a combination horizontal/vertical (ie fleur-di-lis) pattern. Exploratory laparotomy, lysis of intra-abdominal adhesions with hernia sac excision was performed prior to fascial closure. Primary closure of the abdominal fascia was performed with a combination of components separation and placement of biologic mesh over the fascial incision line in onlay fashion. Typically three bone anchors were used to secure the synthetic mesh at the pubic symphysis and two bone anchors to the ASIS bilaterally. The superior aspect of the marlex mesh was sutured to fascia avoiding any incorporation of the costal perichondrium. Quilting sutures were used to"
178657|NCT01644695|O1|Outcome|Candidate for BARS Procedure.|"The subjects selected for this trial were over 18 years of age with an appropriate complex, incisional hernia. These patients were consented and treated with the BARS(bony anchoring reinforcement system)procedure.~Bony Anchoring Reinforcement System : Abdominal exposure was obtained via a lower horizontal incision, a vertical incision, or through a combination horizontal/vertical (ie fleur-di-lis) pattern. Exploratory laparotomy, lysis of intra-abdominal adhesions with hernia sac excision was performed prior to fascial closure. Primary closure of the abdominal fascia was performed with a combination of components separation and placement of biologic mesh over the fascial incision line in onlay fashion. Typically three bone anchors were used to secure the synthetic mesh at the pubic symphysis and two bone anchors to the ASIS bilaterally. The superior aspect of the marlex mesh was sutured to fascia avoiding any incorporation of the costal perichondrium. Quilting sutures were used to"
178658|NCT01644695|E1|Reported Event|All Participants|No participant was excempt from this measure.
178659|NCT01644643|B5|Baseline|Total|Total of all reporting groups
178660|NCT01644643|B4|Baseline|cUTI:CAZ-AVI|cUTI: CAZ-AVI
178661|NCT01644643|B3|Baseline|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178662|NCT01644643|B2|Baseline|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178663|NCT01644643|B1|Baseline|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178664|NCT01644643|P4|Participant Flow|cUTI:CAZ-AVI|cUTI: CAZ-AVI
178665|NCT01644643|P3|Participant Flow|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178666|NCT01644643|P2|Participant Flow|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178667|NCT01644643|P1|Participant Flow|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178668|NCT01644643|O6|Outcome|AVI (3)|300-360 mins after dose
178669|NCT01644643|O5|Outcome|CAZ (3)|300-360 mins after dose
178670|NCT01644643|O4|Outcome|AVI (2)|30-90 mins after dose
178671|NCT01644643|O3|Outcome|CAZ (2)|30-90 mins after dose
178672|NCT01644643|O2|Outcome|AVI (1)|15 mins before/after dose
178673|NCT01644643|O1|Outcome|CAZ (1)|15 mins before/after dose
178674|NCT01644643|O6|Outcome|AVI (3)|300-360 mins after dose
178675|NCT01644643|O5|Outcome|CAZ (3)|300-360 mins after dose
178676|NCT01644643|O4|Outcome|AVI (2)|30-90 mins after dose
178677|NCT01644643|O3|Outcome|CAZ (2)|30-90 mins after dose
178678|NCT01644643|O2|Outcome|AVI (1)|15 mins before/after dose
178679|NCT01644643|O1|Outcome|CAZ (1)|15 mins before/after dose
178680|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178681|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178682|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178683|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178684|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178685|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178686|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178687|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178688|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178689|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178690|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178691|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178692|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178693|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178694|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178695|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
179111|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
178705|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178706|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178707|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178708|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178709|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178710|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178711|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178712|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178713|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178714|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178715|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178716|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178717|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178718|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178719|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178720|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178721|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178722|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178723|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178724|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178725|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178726|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178727|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178728|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178729|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178730|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178731|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178732|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178733|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178734|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178735|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178736|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178737|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178738|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178739|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178740|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178741|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178742|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178743|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178744|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178745|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178746|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178747|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178748|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178749|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178750|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178751|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178752|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178753|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178754|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178755|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178756|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178757|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178758|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178759|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178760|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
186442|NCT01613417|O1|Outcome|Reader 1|Paired exams reviewed by Reader 1
178761|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178762|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178763|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178764|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178765|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178766|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178767|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178768|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178769|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178770|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178771|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178772|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178773|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178774|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178775|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178776|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178777|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178778|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178779|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178780|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178781|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178782|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178783|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178784|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178785|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178786|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178787|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178788|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178789|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178790|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178791|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178792|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178793|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178794|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178795|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178796|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178797|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178798|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178799|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178800|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178801|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178802|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178803|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178804|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178805|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178806|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178807|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178808|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178809|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178810|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178811|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178812|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178813|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178814|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178815|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178816|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
186443|NCT01613417|O3|Outcome|Reader 3|Paired exams reviewed by Reader 3
178817|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178818|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178819|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178820|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
178821|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178822|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178823|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178824|NCT01644643|E4|Reported Event|cUTI:CAZ-AVI|cUTI: CAZ-AVI
178825|NCT01644643|E3|Reported Event|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
178826|NCT01644643|E2|Reported Event|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
178827|NCT01644643|E1|Reported Event|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
178828|NCT01644617|B4|Baseline|Total|Total of all reporting groups
178829|NCT01644617|B3|Baseline|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178830|NCT01644617|B2|Baseline|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178831|NCT01644617|B1|Baseline|MK-8237 12 Development Units (DU)|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
178832|NCT01644617|P3|Participant Flow|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178833|NCT01644617|P2|Participant Flow|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178834|NCT01644617|P1|Participant Flow|MK-8237 12 Development Units (DU)|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
178835|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178836|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178837|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
178838|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178839|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178840|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
178841|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178842|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178843|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
178844|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178845|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178846|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
178847|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178848|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178849|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
178850|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178851|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178852|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
178853|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178854|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178855|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
178856|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
186444|NCT01613417|O2|Outcome|Reader 2|Paired exams reviewed by Reader 2
178857|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178858|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
178859|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178860|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178861|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
178862|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178863|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178864|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
178865|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178866|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178867|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
178868|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178869|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178870|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
178871|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178872|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178873|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
178874|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178875|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178876|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
178877|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178878|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178879|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
178880|NCT01644617|E3|Reported Event|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178881|NCT01644617|E2|Reported Event|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
178882|NCT01644617|E1|Reported Event|MK-8237 12 Development Units (DU)|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
178883|NCT01644500|B4|Baseline|Total|Total of all reporting groups
178884|NCT01644500|B3|Baseline|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
178885|NCT01644500|B2|Baseline|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178886|NCT01644500|B1|Baseline|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178887|NCT01644500|P3|Participant Flow|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
178888|NCT01644500|P2|Participant Flow|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178889|NCT01644500|P1|Participant Flow|1.5 mg Dulaglutide|1.5 milligrams (mg) dulaglutide administered as one subcutaneous (SC) injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178890|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
178891|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
179112|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
178892|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178893|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
178894|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178895|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178896|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
178897|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178898|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178899|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
178900|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178901|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178902|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
178903|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178904|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178905|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
178906|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178907|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178908|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
178909|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178910|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178911|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
178912|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178913|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178914|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
178915|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178916|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178917|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
178918|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178919|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178920|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
178921|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178922|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178923|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
178924|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178925|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178926|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
178927|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178928|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178929|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
178930|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178931|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178932|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
178933|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178934|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178935|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
178936|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178937|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178938|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
178939|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178940|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178941|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
178942|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178943|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178944|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
178945|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178946|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178947|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
178948|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178949|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178950|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
178951|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178952|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178953|NCT01644500|E3|Reported Event|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
178954|NCT01644500|E2|Reported Event|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178955|NCT01644500|E1|Reported Event|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
178956|NCT01644474|B3|Baseline|Total|Total of all reporting groups
178957|NCT01644474|B2|Baseline|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
178958|NCT01644474|B1|Baseline|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
178959|NCT01644474|P2|Participant Flow|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
178960|NCT01644474|P1|Participant Flow|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous (SC) placebo injection for alirocumab every 2 weeks (Q2W) for 24 weeks.
178961|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
178962|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
178963|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
178964|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
178965|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
178966|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
178967|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
178968|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
178969|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
178970|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
178971|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
178972|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
178973|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
178974|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
178975|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
178976|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
178977|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
178978|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
178979|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
178980|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
178981|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
178982|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
178983|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
178984|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
178985|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
178986|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
178987|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
178988|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
178989|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
178990|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
178991|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
178992|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
178993|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
178994|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
178995|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
178996|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
178997|NCT01644474|E2|Reported Event|Alirocumab 75/Up150 mg Q2W|Participants exposed to Alirocumab 75 mg/Up to 150 mg Q2W (mean exposure of 22 weeks).
178998|NCT01644474|E1|Reported Event|Ezetimibe 10 mg|Participants exposed to Ezetimibe 10 mg (mean exposure of 22 weeks).
178999|NCT01644396|B1|Baseline|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179000|NCT01644396|P1|Participant Flow|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179001|NCT01644396|O1|Outcome|Adalimumab|Number of participants with adverse events
179002|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179003|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179004|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179005|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179006|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179007|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179008|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179009|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179010|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179011|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179012|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179013|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179014|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179015|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179016|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179017|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179018|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179019|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179020|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179021|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179022|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179023|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179024|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179025|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179026|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179113|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
179114|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
179027|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179028|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179029|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179030|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179031|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179032|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179033|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179034|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179035|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179036|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179037|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179038|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179039|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179040|NCT01644396|E1|Reported Event|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
179041|NCT01644331|B3|Baseline|Total|Total of all reporting groups
179042|NCT01644331|B2|Baseline|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
179043|NCT01644331|B1|Baseline|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
179044|NCT01644331|P2|Participant Flow|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
179045|NCT01644331|P1|Participant Flow|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
179046|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
179047|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
179048|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
179049|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
179050|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
179051|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
179052|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
179053|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
179054|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
179115|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
179116|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
179055|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
179056|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
179057|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
179058|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
179059|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
179060|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
179061|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
179062|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
179063|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
179064|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
179065|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
179066|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
179067|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
179068|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
179069|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
179070|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
179071|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
179072|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
179073|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
179074|NCT01644331|E2|Reported Event|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
179075|NCT01644331|E1|Reported Event|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
179076|NCT01644292|B1|Baseline|Training Intervention|EPIC WheelS : EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.
179077|NCT01644292|P1|Participant Flow|Training Intervention|EPIC WheelS : EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.
179078|NCT01644292|O1|Outcome|Training Intervention|EPIC WheelS : EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.
179079|NCT01644292|E1|Reported Event|Training Intervention|EPIC WheelS : EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.
179080|NCT01644240|B4|Baseline|Total|Total of all reporting groups
179081|NCT01644240|B3|Baseline|TD-8954 Dose 2|TD-8954: Intravenous infusion
179118|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
179119|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
179120|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
179121|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
179122|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
179123|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
179124|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
179125|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
179126|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
179127|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
179128|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
179129|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
179130|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
179131|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
179132|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
179133|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
179134|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
179135|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
179136|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
179137|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
179138|NCT01644240|E3|Reported Event|TD-8954 Dose 2|TD-8954: Intravenous infusion
179139|NCT01644240|E2|Reported Event|Placebo|Placebo - saline: Intravenous infusion
179140|NCT01644240|E1|Reported Event|TD-8954 Dose 1|TD-8954: Intravenous infusion
179141|NCT01644188|B3|Baseline|Total|Total of all reporting groups
179142|NCT01644188|B2|Baseline|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179143|NCT01644188|B1|Baseline|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179144|NCT01644188|P2|Participant Flow|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179145|NCT01644188|P1|Participant Flow|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg every 2 weeks (Q2W) and oral placebo capsule for ezetimibe daily added to stable Lipid­ Modifying Therapy (LMT) for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low density lipoprotein cholesterol (LDL-C) level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179146|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179147|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179148|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179149|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179150|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179151|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179152|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179153|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179154|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179155|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179156|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179157|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179158|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179159|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179160|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179161|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179162|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
180671|NCT01640951|P2|Participant Flow|AIN150 FI_AIN300 FI|AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
179163|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179164|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179165|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179166|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179167|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179168|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179169|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179170|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179171|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179172|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179173|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179174|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179175|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179176|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179177|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179178|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179179|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179180|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179181|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179182|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179183|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179184|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179185|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179186|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179187|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179188|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179189|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179190|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179191|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179192|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179193|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179194|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179195|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179196|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
179197|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
179198|NCT01644188|E2|Reported Event|Ezetimibe 10 mg|Participants exposed to Ezetimibe 10 mg added to stable LMT (mean exposition of 90 weeks).
179199|NCT01644188|E1|Reported Event|Alirocumab 75/Up to 150 mg Q2W|Participants exposed to Alirocumab 75 /up to 150 mg Q2W added to stable LMT (mean exposition of 90 weeks).
179200|NCT01644175|B3|Baseline|Total|Total of all reporting groups
179201|NCT01644175|B2|Baseline|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
179202|NCT01644175|B1|Baseline|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
179203|NCT01644175|P2|Participant Flow|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
179204|NCT01644175|P1|Participant Flow|Placebo Q2W|Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 52 weeks.
179205|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
179206|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
179207|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
179208|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
179209|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
179210|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
179211|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
179212|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
179213|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
179214|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
179215|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
179216|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
179217|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
179218|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
179219|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
179220|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
179221|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
179222|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
179223|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
179224|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
179225|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
179226|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
179227|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
179228|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
179229|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
179230|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
179231|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
179232|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
179233|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
179234|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
179235|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
179236|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
179237|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
179238|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
179239|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
179240|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
179241|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
179242|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
179243|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
179244|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
179245|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
179246|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
179247|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
179248|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
179249|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
179250|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
179251|NCT01644175|E2|Reported Event|Alirocumab 75 /up to 150 mg Q2W|Participants exposed to alirocumab 75 mg /up to 150 mg SC injection Q2W added to stable LMT (mean exposition of 46 weeks).
179252|NCT01644175|E1|Reported Event|Placebo Q2W|Participants exposed to placebo (for alirocumab) SC injection Q2W added to stable LMT (mean exposition of 45 weeks).
179253|NCT01644058|B1|Baseline|Immediate Loading|Immediate loading of 2 endo-osseous mandibular implants
179254|NCT01644058|P1|Participant Flow|Immediate Loading|Immediate loading of 2 endo-osseous mandibular implants
179255|NCT01644058|O1|Outcome|Immediate Loading|"Immediate loading of 2 endo-osseous mandibular implants~Immediate loading"
179256|NCT01644058|O1|Outcome|Immediate Loading|Immediate loading of 2 endo-osseous mandibular implants
179257|NCT01644058|E1|Reported Event|Immediate Loading|Immediate loading of 2 endo-osseous mandibular implants
179258|NCT01643928|B6|Baseline|Total|Total of all reporting groups
179259|NCT01643928|B5|Baseline|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
179260|NCT01643928|B4|Baseline|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
179261|NCT01643928|B3|Baseline|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
179262|NCT01643928|B2|Baseline|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
179589|NCT01643616|P2|Participant Flow|Group NS|"Nerve stimulation technique:~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
186445|NCT01613417|O1|Outcome|Reader 1|Paired exams reviewed by Reader 1
179263|NCT01643928|B1|Baseline|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
179264|NCT01643928|P5|Participant Flow|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
179265|NCT01643928|P4|Participant Flow|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
179266|NCT01643928|P3|Participant Flow|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
179267|NCT01643928|P2|Participant Flow|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
179268|NCT01643928|P1|Participant Flow|PF-05280586/PF-05280586/PF-05280586|This group received intravenous (IV) rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
179269|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179270|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179271|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179272|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179273|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
186446|NCT01613417|O3|Outcome|Reader 3|Paired exams reviewed by Reader 3
179274|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179275|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179276|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179277|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179278|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179279|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179280|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179281|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179282|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179283|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179284|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179554|NCT01643902|O1|Outcome|IV tPA|"Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria~IV tPA: IV tPA 0.9 mg/kg maximum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target door to needle time of 60 minutes or less from ED arrival."
186447|NCT01613417|O2|Outcome|Reader 2|Paired exams reviewed by Reader 2
179285|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179286|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179287|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179288|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179289|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179290|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179291|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179292|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179293|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179294|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179295|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179296|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179297|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179298|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179299|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179300|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179301|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179302|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179303|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179304|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179305|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179306|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179590|NCT01643616|P1|Participant Flow|Group US|"Ultrasound guided block :~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
186448|NCT01613417|O1|Outcome|Reader 1|Paired exams reviewed by Reader 1
179307|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179308|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179309|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179310|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179311|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179312|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179313|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179314|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179315|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179316|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179317|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179591|NCT01643616|O2|Outcome|Group NS|"Nerve stimulation technique:~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
180672|NCT01640951|P1|Participant Flow|AIN150FI|AIN457 150 mg - Fixed Interval (FI)
179318|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179319|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179320|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179321|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179322|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179323|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179324|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179325|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179326|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179327|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179328|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179555|NCT01643902|O1|Outcome|IV Rt-PA|"Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria~IV tPA: IV tPA 0.9 mg/kg maximum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target door to needle time of 60 minutes or less from Emergency department (ED) arrival."
179329|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179330|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179331|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179332|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179333|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179334|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179335|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179336|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179337|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179338|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179339|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179340|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179341|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179342|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179343|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179344|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179345|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179346|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179347|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179348|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179349|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179350|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179592|NCT01643616|O1|Outcome|Group US|"Ultrasound guided block :~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
180673|NCT01640951|O8|Outcome|AIN300 OL|AIN457 300 mg Open-label (OL)
179351|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179352|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179353|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179354|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179355|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179356|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179357|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179358|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179359|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179360|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179361|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179556|NCT01643902|E1|Reported Event|IV tPA|"Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria~IV tPA: IV tPA 0.9 mg/kg maximum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target door to needle time of 60 minutes or less from ED arrival."
179362|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179363|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179364|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179365|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179366|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179367|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179368|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179369|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179370|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179371|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179372|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179593|NCT01643616|O2|Outcome|Group NS|"Nerve stimulation technique:~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
180820|NCT01640353|E1|Reported Event|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
179373|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179374|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179375|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179376|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179377|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179378|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179379|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179380|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179381|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179382|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179383|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179384|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179385|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179386|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179387|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179388|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179389|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179390|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179391|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179392|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179393|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179394|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179557|NCT01643876|B1|Baseline|Palatal Brushing|"Palatal brushing after each meal for 3 months.~Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing."
180821|NCT01640340|B3|Baseline|Total|Total of all reporting groups
179395|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179396|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179397|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179398|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179399|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179400|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179401|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179402|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179403|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179404|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179405|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179594|NCT01643616|O1|Outcome|Group US|"Ultrasound guided block :~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
180895|NCT01640184|B4|Baseline|Total|Total of all reporting groups
179406|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179407|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179408|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179409|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179410|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179411|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179412|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179413|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179414|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179415|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179416|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179595|NCT01643616|O2|Outcome|Group NS|"Nerve stimulation technique:~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
181000|NCT01639703|O1|Outcome|Glutamine Synthetase 0%|Absence of glutamine synthetase labelling
179417|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179418|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179419|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179420|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179421|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179422|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179423|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179424|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179425|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179426|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179427|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179428|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179429|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179430|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179431|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179432|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179433|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179434|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179435|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179436|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179437|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179438|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179558|NCT01643876|P1|Participant Flow|Palatal Brushing|"Palatal brushing after each meal for 3 months.~Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing."
186449|NCT01613417|O3|Outcome|Reader 3|Paired exams reviewed by Reader 3
179439|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179440|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179441|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179442|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179443|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179444|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179445|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179446|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179447|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179448|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179449|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179559|NCT01643876|O1|Outcome|Palatal Brushing|"Palatal brushing after each meal for 3 months.~Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing."
181001|NCT01639703|O4|Outcome|CD31 >50%|Quantification of CD31 labelling greater than 50%
179450|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179451|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179452|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179453|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179454|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179455|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179456|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179457|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179458|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179459|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179460|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179461|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179462|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179463|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179464|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179465|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179466|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179467|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179468|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179469|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179470|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179471|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179596|NCT01643616|O1|Outcome|Group US|"Ultrasound guided block :~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
186450|NCT01613417|O2|Outcome|Reader 2|Paired exams reviewed by Reader 2
179472|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179473|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179474|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179475|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179476|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179477|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179478|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179479|NCT01643928|O5|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
179480|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
179481|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
179482|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
179560|NCT01643876|O1|Outcome|Palatal Brushing|"Palatal brushing after each meal for 3 months.~Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing."
179483|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
179484|NCT01643928|O5|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
179485|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
179486|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
179487|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
179488|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
179489|NCT01643928|O5|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
179490|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
179491|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
179492|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
179493|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
179597|NCT01643616|E2|Reported Event|Group NS|"Nerve stimulation technique:~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
180674|NCT01640951|O7|Outcome|AIN300 SoR _ AIN300 FI|AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
179494|NCT01643928|O5|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
179495|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
179496|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
179497|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
179498|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
179499|NCT01643928|O5|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
179500|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
179501|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
179502|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
179503|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
179504|NCT01643928|O5|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
179598|NCT01643616|E1|Reported Event|Group US|"Ultrasound guided block :~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
180675|NCT01640951|O6|Outcome|AIN300 SoR|AIN457 300 mg - Start of Relapse (SoR)
179505|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
179506|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
179507|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
179508|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
179509|NCT01643928|O7|Outcome|Rituximab-US Total|Participants who received Rituximab-US in the B3281001 study were either assigned Rituximab-US in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-US participants.
179510|NCT01643928|O6|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
179511|NCT01643928|O5|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
179512|NCT01643928|O4|Outcome|Rituximab-EU Total|Participants who received Rituximab-EU in the B3281001 study were either assigned Rituximab-EU in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-EU participants.
179513|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
179514|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
179515|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
179516|NCT01643928|O7|Outcome|Rituximab-US Total|Participants who received Rituximab-US in the B3281001 study were either assigned Rituximab-US in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-US participants.
179517|NCT01643928|O6|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
179518|NCT01643928|O5|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
179519|NCT01643928|O4|Outcome|Rituximab-EU Total|Participants who received Rituximab-EU in the B3281001 study were either assigned Rituximab-EU in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-EU participants.
179520|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
179521|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
179522|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
179523|NCT01643928|O7|Outcome|Rituximab-US Total|Participants who received Rituximab-US in the B3281001 study were either assigned Rituximab-US in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-US participants.
179524|NCT01643928|O6|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
179525|NCT01643928|O5|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
179526|NCT01643928|O4|Outcome|Rituximab-EU Total|Participants who received Rituximab-EU in the B3281001 study were either assigned Rituximab-EU in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-EU participants.
179527|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
179528|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
179529|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
179530|NCT01643928|O7|Outcome|Rituximab-US Total|Participants who received Rituximab-US in the B3281001 study were either assigned Rituximab-US in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-US participants.
179599|NCT01643525|B1|Baseline|Nautilus NeuroWave Recording Arm|"Nautilus NeuroWaveTM System~Nautilus NeuroWaveTM System: Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke."
181002|NCT01639703|O3|Outcome|CD31 10-50%|Quantification of CD31 labelling from 10 to 50%
179531|NCT01643928|O6|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
179532|NCT01643928|O5|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
179533|NCT01643928|O4|Outcome|Rituximab-EU Total|Participants who received Rituximab-EU in the B3281001 study were either assigned Rituximab-EU in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-EU participants.
179534|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
179535|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
179536|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
179537|NCT01643928|E15|Reported Event|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179538|NCT01643928|E14|Reported Event|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179539|NCT01643928|E13|Reported Event|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179540|NCT01643928|E12|Reported Event|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179541|NCT01643928|E11|Reported Event|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179561|NCT01643876|E1|Reported Event|Palatal Brushing|"Palatal brushing after each meal for 3 months.~Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing."
179542|NCT01643928|E10|Reported Event|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179543|NCT01643928|E9|Reported Event|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179544|NCT01643928|E8|Reported Event|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179545|NCT01643928|E7|Reported Event|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179546|NCT01643928|E6|Reported Event|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179547|NCT01643928|E5|Reported Event|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179548|NCT01643928|E4|Reported Event|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
179549|NCT01643928|E3|Reported Event|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179550|NCT01643928|E2|Reported Event|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179551|NCT01643928|E1|Reported Event|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
179552|NCT01643902|B1|Baseline|IV tPA|"Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria~IV tPA: IV tPA 0.9 mg/kg maximum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target door to needle time of 60 minutes or less from ED arrival."
179553|NCT01643902|P1|Participant Flow|IV tPA|"Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria~rt-PA: IV rt-PA 0.9 mg/kg minimum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target foor to needle time of 60 minutes or less from ED arrival."
180676|NCT01640951|O5|Outcome|AIN150 SOR_AIN300 FI|AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
179562|NCT01643798|B1|Baseline|Pretreatment & Stimulation|Outside of the 3T magnetic resonance imaging (MRI) scanner, participants underwent resting motor threshold assessment, left dorsolateral prefrontal cortex localization and preliminary pain testing. Next, participants were placed in the scanner for baseline pain testing. After baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive approximately 10 ml intravenous naloxone (0.1mg/kg) or saline immediately prior to 20 minutes of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20 minutes of real left DLPFC rTMS. Participants then returned to the scanner for the final block test.
179563|NCT01643798|P2|Participant Flow|Naloxone and Stimulation, Then Saline and Stimulation|Participants received an intravenous infusion of 0.1mg/kg Naloxone immediately prior to sham and real rTMS of the left dorsolateral prefrontal cortex. One week later, participants received an intravenous infusion of 10ml sterile saline immediately prior to sham and real rTMS of the left dorsolateral prefrontal cortex
179564|NCT01643798|P1|Participant Flow|Saline and Stimulation, Then Naloxone and Stimulation|Participants received an intravenous infusion of 10ml sterile saline immediately prior to sham and real rTMS of the left dorsolateral prefrontal cortex. One week later, participants received an intravenous infusion of 0.1 mg/kg Naloxone immediately prior to sham and real rTMS of the left dorsolateral prefrontal cortex
179565|NCT01643798|O4|Outcome|Real rTMS With Naloxone|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit. Whole-brain and anatomical region of interest analysis were performed. The numbers below represent midbrain percent signal change.
179566|NCT01643798|O3|Outcome|Sham rTMS With Naloxone|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit. Whole-brain and anatomical region of interest analysis were performed. The numbers below represent midbrain percent signal change.
179567|NCT01643798|O2|Outcome|Real rTMS With Saline|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit. Whole-brain and anatomical region of interest analysis were performed. The numbers below represent midbrain percent signal change.
179568|NCT01643798|O1|Outcome|Sham rTMS With Saline|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit. Whole-brain and anatomical region of interest analysis were performed. The numbers below represent midbrain percent signal change.
179569|NCT01643798|O4|Outcome|Real rTMS With Naloxone|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit.
179570|NCT01643798|O3|Outcome|Sham rTMS With Naloxone|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit.
179585|NCT01643668|E1|Reported Event|Treatment Arm|"Reduced Intensity Conditioning with Busulfan/Clofarabine followed by Allogeneic Stem Cell Transplantation (BuClo RIC SCT)~Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
179586|NCT01643616|B3|Baseline|Total|Total of all reporting groups
179571|NCT01643798|O2|Outcome|Real rTMS With Saline|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit.
179572|NCT01643798|O1|Outcome|Sham rTMS With Saline|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit.
179573|NCT01643798|E1|Reported Event|Pretreatment & Stimulation|
179574|NCT01643668|B1|Baseline|BuClo RIC + SCT|"BuClo RIC SCT~Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
179575|NCT01643668|P1|Participant Flow|BuClo RIC + SCT|"BuClo RIC SCT~Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
179576|NCT01643668|O1|Outcome|Treatment Arm|"Reduced Intensity Conditioning with Busulfan/Clofarabine followed by Allogeneic Stem Cell Transplantation (BuClo RIC SCT)~Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
179577|NCT01643668|O1|Outcome|Treatment Arm|"Reduced Intensity Conditioning with Busulfan/Clofarabine followed by Allogeneic Stem Cell Transplantation (BuClo RIC SCT)~Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
179578|NCT01643668|O1|Outcome|Treatment Arm|"Reduced Intensity Conditioning with Busulfan/Clofarabine followed by Allogeneic Stem Cell Transplantation (BuClo RIC SCT)~Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
179579|NCT01643668|O1|Outcome|Treatment Arm|"Reduced Intensity Conditioning with Busulfan/Clofarabine followed by Allogeneic Stem Cell Transplantation (BuClo RIC SCT)~Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
179580|NCT01643668|O1|Outcome|Treatment Arm|"Reduced Intensity Conditioning with Busulfan/Clofarabine followed by Allogeneic Stem Cell Transplantation (BuClo RIC SCT)~Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
179581|NCT01643668|O1|Outcome|Treatment Arm|"Reduced Intensity Conditioning with Busulfan/Clofarabine followed by Allogeneic Stem Cell Transplantation (BuClo RIC SCT)~Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
179582|NCT01643668|O1|Outcome|Treatment Arm|"Reduced Intensity Conditioning with Busulfan/Clofarabine followed by Allogeneic Stem Cell Transplantation (BuClo RIC SCT)~Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
179583|NCT01643668|O1|Outcome|Treatment Arm|"Reduced Intensity Conditioning with Busulfan/Clofarabine followed by Allogeneic Stem Cell Transplantation (BuClo RIC SCT)~Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
179584|NCT01643668|O1|Outcome|Treatment Arm|"Reduced Intensity Conditioning with Busulfan/Clofarabine followed by Allogeneic Stem Cell Transplantation (BuClo RIC SCT)~Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation~Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
179587|NCT01643616|B2|Baseline|Group NS|"Nerve stimulation technique:~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
179588|NCT01643616|B1|Baseline|Group US|"Ultrasound guided block :~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
179600|NCT01643525|P1|Participant Flow|Nautilus NeuroWave Recording Arm|"Nautilus NeuroWaveTM System~Nautilus NeuroWaveTM System: Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke."
179601|NCT01643525|O1|Outcome|Nautilus NeuroWave Recording Arm|"Nautilus NeuroWaveTM System~Nautilus NeuroWaveTM System: Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke."
179602|NCT01643525|E1|Reported Event|Nautilus NeuroWave Recording Arm|"Nautilus NeuroWaveTM System~Nautilus NeuroWaveTM System: Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke."
179603|NCT01643213|B3|Baseline|Total|Total of all reporting groups
179604|NCT01643213|B2|Baseline|Control to Treatment|Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)
179605|NCT01643213|B1|Baseline|Treatment to Control|Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)
179606|NCT01643213|P2|Participant Flow|Control to Treatment|Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)
179607|NCT01643213|P1|Participant Flow|Treatment to Control|Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)
179608|NCT01643213|O2|Outcome|Control to Treatment|Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)
179609|NCT01643213|O1|Outcome|Treatment to Control|Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)
179610|NCT01643213|E2|Reported Event|Control to Treatment|Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)
179611|NCT01643213|E1|Reported Event|Treatment to Control|Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)
179612|NCT01643044|B3|Baseline|Total|Total of all reporting groups
179613|NCT01643044|B2|Baseline|Control|"Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.~Nutrition time control/placebo intervention: This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos."
179614|NCT01643044|B1|Baseline|Alcohol Intervention|"Participants in this condition review tailored videos and normed feedback regarding their alcohol use and possible consequences of drinking. Next participants view a goal setting section describing possible ways to quit drinking alcohol and the participant is able to indicate a change goal (if any) and is helped through a specific change plan, should they set a change goal.~Computer-delivered, brief intervention on alcohol use: A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant."
179615|NCT01643044|P2|Participant Flow|Control|"Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.~Nutrition time control/placebo intervention: This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos."
179616|NCT01643044|P1|Participant Flow|Alcohol Intervention|"Participants in this condition review tailored videos and normed feedback regarding their alcohol use and possible consequences of drinking. Next participants view a goal setting section describing possible ways to quit drinking alcohol and the participant is able to indicate a change goal (if any) and is helped through a specific change plan, should they set a change goal.~Computer-delivered, brief intervention on alcohol use: A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant."
179617|NCT01643044|O2|Outcome|Control|"Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.~Nutrition time control/placebo intervention: This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos."
179618|NCT01643044|O1|Outcome|Alcohol Intervention|"Participants in this condition review tailored videos and normed feedback regarding their alcohol use and possible consequences of drinking. Next participants view a goal setting section describing possible ways to quit drinking alcohol and the participant is able to indicate a change goal (if any) and is helped through a specific change plan, should they set a change goal.~Computer-delivered, brief intervention on alcohol use: A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant."
179619|NCT01643044|E2|Reported Event|Control|"Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.~Nutrition time control/placebo intervention: This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos."
179620|NCT01643044|E1|Reported Event|Alcohol Intervention|"Participants in this condition review tailored videos and normed feedback regarding their alcohol use and possible consequences of drinking. Next participants view a goal setting section describing possible ways to quit drinking alcohol and the participant is able to indicate a change goal (if any) and is helped through a specific change plan, should they set a change goal.~Computer-delivered, brief intervention on alcohol use: A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant."
179621|NCT01642914|B4|Baseline|Total|Total of all reporting groups
179622|NCT01642914|B3|Baseline|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179623|NCT01642914|B2|Baseline|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179624|NCT01642914|B1|Baseline|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179625|NCT01642914|P3|Participant Flow|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179718|NCT01642615|O1|Outcome|Healing Phase: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
179626|NCT01642914|P2|Participant Flow|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179627|NCT01642914|P1|Participant Flow|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179628|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179629|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179630|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast
179631|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179632|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179633|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179634|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179635|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179636|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179637|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179638|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179639|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179640|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179641|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179642|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179643|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179644|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179645|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179646|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179647|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179648|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179649|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179650|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179651|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179652|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179653|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179654|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179655|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179656|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179657|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179658|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179659|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179660|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179661|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179662|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179663|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
180677|NCT01640951|O4|Outcome|AIN150 SoR|AIN457 150 mg - Start of Relapse (SoR)
179664|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179665|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179666|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179667|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179668|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179669|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179670|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179671|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179672|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179673|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179674|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179675|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179676|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179677|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179678|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179679|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179680|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179681|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179682|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179683|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179684|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179685|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179686|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179687|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179688|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179689|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179690|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179691|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179692|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179693|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179694|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179695|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179696|NCT01642914|O2|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179697|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179698|NCT01642914|E3|Reported Event|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179699|NCT01642914|E2|Reported Event|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179700|NCT01642914|E1|Reported Event|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
179717|NCT01642615|O1|Outcome|Maintenance Phase: Dexlansoprazole 30 mg|Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.
179701|NCT01642732|B1|Baseline|Everolimus With Combined Hormonal and Radiation Therapy|"Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.~Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).~Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.~Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.~Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study."
179702|NCT01642732|P1|Participant Flow|Everolimus With Combined Hormonal and Radiation Therapy|"Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.~Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).~Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.~Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.~Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study."
179703|NCT01642732|O1|Outcome|Everolimus With Combined Hormonal and Radiation Therapy|"Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.~Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).~Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.~Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.~Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study."
179704|NCT01642732|O1|Outcome|Everolimus With Combined Hormonal and Radiation Therapy|"Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.~Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).~Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.~Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.~Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study."
179705|NCT01642732|E1|Reported Event|Everolimus With Combined Hormonal and Radiation Therapy|"Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.~Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).~Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.~Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.~Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study."
179706|NCT01642615|B1|Baseline|All Participants|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks in the Open Label Healing Phase. Participants with healing of EE were eligible to participate in the Maintenance Phase.
179707|NCT01642615|P3|Participant Flow|Maintenance Phase: Placebo|Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
179708|NCT01642615|P2|Participant Flow|Maintenance Phase: Dexlansoprazole 30 mg|Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.
179709|NCT01642615|P1|Participant Flow|Healing Phase: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
179710|NCT01642615|O2|Outcome|Maintenance Phase: Placebo|Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
179711|NCT01642615|O1|Outcome|Maintenance Phase: Dexlansoprazole 30 mg|Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.
179712|NCT01642615|O1|Outcome|Healing Phase: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
179713|NCT01642615|O2|Outcome|Maintenance Phase: Placebo|Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
179714|NCT01642615|O1|Outcome|Maintenance Phase: Dexlansoprazole 30 mg|Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.
179715|NCT01642615|O1|Outcome|Healing Phase: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
179716|NCT01642615|O2|Outcome|Maintenance Phase: Placebo|Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
186451|NCT01613417|O1|Outcome|Reader 1|Paired exams reviewed by Reader 1
179719|NCT01642615|E3|Reported Event|Maintenance Phase: Placebo|Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
179720|NCT01642615|E2|Reported Event|Maintenance Phase: Dexlansoprazole 30 mg|Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.
179721|NCT01642615|E1|Reported Event|Healing Phase: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
179722|NCT01642602|B1|Baseline|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
179723|NCT01642602|P1|Participant Flow|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
179724|NCT01642602|O1|Outcome|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
179725|NCT01642602|O1|Outcome|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
179726|NCT01642602|E1|Reported Event|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
179727|NCT01642589|B3|Baseline|Total|Total of all reporting groups
179728|NCT01642589|B2|Baseline|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
179729|NCT01642589|B1|Baseline|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
179730|NCT01642589|P2|Participant Flow|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
179731|NCT01642589|P1|Participant Flow|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
179732|NCT01642589|O2|Outcome|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
179733|NCT01642589|O1|Outcome|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
179734|NCT01642589|O2|Outcome|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
179735|NCT01642589|O1|Outcome|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
179736|NCT01642589|O2|Outcome|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
179737|NCT01642589|O1|Outcome|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
179738|NCT01642589|O2|Outcome|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
179739|NCT01642589|O1|Outcome|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
179740|NCT01642589|O2|Outcome|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
179741|NCT01642589|O1|Outcome|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
179742|NCT01642589|E2|Reported Event|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
179743|NCT01642589|E1|Reported Event|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
179744|NCT01642485|B1|Baseline|All Study Participants|Subjects participating in the study attended for screening, two treatment periods (periods 1 and 2) of 4 assessment days each and a follow-up visit. Data obtained on study days 1 and 2 compared the ECG effects of different types of food and placebo. Each period consisted of a baseline ECG day (day –1) and treatment days (days 1–3). Moxifloxacin was given in fasted condition or with Continental breakfast, on day 3 of each study period. The two periods were separated by at least 3 days to allow for the effects of moxifloxacin to wash-out. No wash-out was required between the other treatments investigated. The ECG and samples for PK and PD analysis on the treatment days were taken at the corresponding clock time points as on the baseline days. Each subject received all treatments and all the comparisons between treatment effects were made intra-individually reducing the anticipated variability and thereby reducing the sample size.
179745|NCT01642485|P8|Participant Flow|Sequence 8|"Period1:~Day 1: FDA breakfast Day 2: Placebo Day 3: Moxiloxacin 400 mg fed (with continental breakfast) Washout period: 3 days~Period 2:~Day 1: Insulin Clamp Day 2: Continental breakfast Day 3: Moxifloxacin 400 mg fasted"
179746|NCT01642485|P7|Participant Flow|Sequence 7|"Period1:~Day 1: Continental breakfast Day 2: FDA breakfast Day 3: Moxiloxacin 400 mg fed (with continental breakfast) Washout period: 3 days~Period 2:~Day 1: Placebo Day 2: Insulin Clamp Day 3: Moxifloxacin 400 mg fasted"
179747|NCT01642485|P6|Participant Flow|Sequence 6|"Period1:~Day 1: Insulin Clamp Day 2: Continental breakfast Day 3: Moxiloxacin 400 mg fed (with continental breakfast) Washout period: 3 days~Period 2:~Day 1: FDA breakfast Day 2: Placebo Day 3: Moxifloxacin 400 mg fasted"
179748|NCT01642485|P5|Participant Flow|Sequence 5|"Period1:~Day 1: Placebo Day 2: Insulin Clamp Day 3: Moxiloxacin 400 mg fed (with continental breakfast) Washout period: 3 days~Period 2:~Day 1: Continental breakfast Day 2:FDA breakfast Day 3: Moxifloxacin 400 mg fasted"
179749|NCT01642485|P4|Participant Flow|Sequence 4|"Period1:~Day 1: FDA breakfast Day 2: Placebo Day 3: Moxiloxacin 400 mg fasted Washout period: 3 days~Period 2:~Day 1: Insulin Clamp Day 2: Continental breakfast Day 3: Moxifloxacin 400 mg fed (with continental breakfast)"
179750|NCT01642485|P3|Participant Flow|Sequence 3|"Period1:~Day 1: Continental breakfast Day 2: FDA breakfast Day 3: Moxiloxacin 400 mg fasted Washout period: 3 days~Period 2:~Day 1: Placebo Day 2: Insulin Clamp Day 3: Moxifloxacin 400 mg fed (with continental breakfast)"
179751|NCT01642485|P2|Participant Flow|Sequence 2|"Period1:~Day 1: Insulin Clamp Day 2: Continental breakfast Day 3: Moxiloxacin 400 mg fasted Washout period: 3 days~Period 2:~Day 1: FDA breakfast Day 2: Placebo Day 3: Moxifloxacin 400 mg fed (with continental breakfast)"
186452|NCT01613417|O3|Outcome|Reader 3|Paired exams reviewed by Reader 3
179752|NCT01642485|P1|Participant Flow|Sequence 1|"Period1:~Day 1: Placebo Day 2: Insulin Clamp Day 3: Moxiloxacin 400 mg fasted Washout period: 3 days~Period 2:~Day 1: Continental breakfast Day 2:FDA breakfast Day 3: Moxifloxacin 400 mg fed (with continental breakfast)"
179753|NCT01642485|O4|Outcome|Japanese Fed Group|The results of concentration-effect analysis: the effect of moxifloxacin on QTcF (double difference of QTcF) at the time point of maximum mean concentrationof moxifloxacin (4h)
179754|NCT01642485|O3|Outcome|Japanese Fasted Group|The results of concentration-effect analysis: the effect of moxifloxacin on QTcF (double difference of QTcF) at the time point of maximum mean concentrationof moxifloxacin (4h)
179755|NCT01642485|O2|Outcome|Caucasian Fed Group|The results of concentration-effect analysis: the effect of moxifloxacin on QTcF (double difference of QTcF) at the time point of maximum mean concentrationof moxifloxacin (4h)
179756|NCT01642485|O1|Outcome|Caucasian Fasted Group|The results of concentration-effect analysis: the effect of moxifloxacin on QTcF (double difference of QTcF) at the time point of maximum mean concentrationof moxifloxacin (1h)
179757|NCT01642485|O3|Outcome|C-peptide|A euglycaemic/hyperinsulinaemic clamp involves acutely raising the plasma insulin levels to a steady state and maintaining a state of euglycaemia with a glucose infusion, thereby effectively stopping endogenous glucose and insulin production, and as a result reducing the release of C-peptides. This technique will firstly test whether hyperinsulinaemia has an effect on QT interval, and secondly whether C-peptide levels play any role in the proposed effect on the QT interval.
179758|NCT01642485|O2|Outcome|Glucose|A euglycaemic/hyperinsulinaemic clamp was used to stop any endogenous C-peptide and insulin production. The clamp acutely raised the plasma insulin concentrations to a steady-state and maintained glucose concentrations at/or slightly lower than the individual subjects baseline reading. For each subject two 18G cannulas were inserted, one in the antecubital fossa for insulin and glucose infusions, and one for pharmacokinetic (PK) and blood glucose sampling.
179759|NCT01642485|O1|Outcome|Insulin Clamp|A euglycaemic/hyperinsulinaemic clamp was used to stop any endogenous C-peptide and insulin production. The clamp acutely raised the plasma insulin concentrations to a steady-state and maintained glucose concentrations at/or slightly lower than the individual subjects baseline reading. For each subject two 18G cannulas were inserted, one in the antecubital fossa for insulin and glucose infusions, and one for pharmacokinetic (PK) and blood glucose sampling.
179760|NCT01642485|O2|Outcome|Placebo|Time matched absolute value for QTcF for placebo treatment.
179761|NCT01642485|O1|Outcome|Moxifloxacin 400 mg Fasted|The highest change was at 2.5h time point, which is presented here.
179762|NCT01642485|O3|Outcome|Placebo at Baseline|a baseline QTcF measured on Day -1 of each period
179763|NCT01642485|O2|Outcome|Continental Breakfast|"Continental breakfast: High carbohydrate breakfast (>70% carbohydrates)- On the assumption that increases in C-peptide levels are responsible for the QTc shortening observed after a meal, a greater effect on QTc compared to a low carbohydrate breakfast (FDA standard breakfast) should be observed.~QTcF change from a baseline presented."
179764|NCT01642485|O1|Outcome|FDA Breakfast|FDA breakfast: Calorie reduced FDA standard breakfast (58% fat, low carbohydrates)- On the assumption that increases in C-peptide levels are responsible for the QTc shortening observed after a meal, a lesser effect on QTc compared to a carbohydrate rich breakfast should be observed.
179765|NCT01642485|O2|Outcome|Fed Group|This study was designed as an open-label, randomized, placebo-controlled, crossover trial that evaluated the effect of a 400 mg oral dose of moxifloxacin in fed conditions to a baseline and a placebo treatment. Data obtained on study days 1 and 2 compared the ECG effects of different types of food and placebo. Each period consisted of a baseline ECG day (day –1) and treatment days (days 1–3). Moxifloxacin was given in either the fed or fasted condition, on day 3 of each study period. The two periods were separated by at least 3 days to allow for the effects of moxifloxacin to wash-out. The ECG and samples for PK and PD analysis on the treatment days were taken at the corresponding clock time points as on the baseline days. Each subject received all treatments and all the comparisons between treatment effects were made intra-individually reducing the anticipated variability and thereby reducing the sample size.
179766|NCT01642485|O1|Outcome|Fasted Group|This study was designed as an open-label, randomized, placebo-controlled, crossover trial that evaluated the effect of a 400 mg oral dose of moxifloxacin in fasted conditions to a baseline and a placebo treatment. Data obtained on study days 1 and 2 compared the ECG effects of different types of food and placebo. Each period consisted of a baseline ECG day (day –1) and treatment days (days 1–3). Moxifloxacin was given in either the fed or fasted condition, on day 3 of each study period. The two periods were separated by at least 3 days to allow for the effects of moxifloxacin to wash-out. The ECG and samples for PK and PD analysis on the treatment days were taken at the corresponding clock time points as on the baseline days. Each subject received all treatments and all the comparisons between treatment effects were made intra-individually reducing the anticipated variability and thereby reducing the sample size.
179767|NCT01642485|E2|Reported Event|Moxifloxacin 400 mg Fed|"Moxifloxacin with food: Currently, there is no published data showing the effects of a single 400 mg oral dose of moxifloxacin on the ECG/QT/QTc after food.~No significant other Adverse Events have been reported."
179768|NCT01642485|E1|Reported Event|Moxifloxacin 400 mg Fasted|"Moxifloxacin fasted: One single dose of 400mg moxifloxacin after fasting - This is the standard probe for the assessment of assay sensitivity in Thorough QT (TQT) studies.~No significant other Adverse Events have been reported."
179769|NCT01642407|B1|Baseline|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179770|NCT01642407|P1|Participant Flow|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179849|NCT01642212|P3|Participant Flow|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179771|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179772|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179773|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179774|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179775|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179776|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179777|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179778|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179779|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179780|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179781|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179782|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179783|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179784|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179785|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179786|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179787|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179788|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179789|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
180678|NCT01640951|O3|Outcome|AIN300 FI|AIN457 300 mg - Fixed Interval (FI)
179790|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179791|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179792|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179793|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179794|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179795|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179796|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179797|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179798|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179799|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179800|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179801|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179802|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179803|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179804|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179805|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179806|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179807|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
181003|NCT01639703|O2|Outcome|CD31 1-10%|Quantification of CD31 labelling from 1 to 10%
179808|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179809|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179810|NCT01642407|E1|Reported Event|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
179811|NCT01642277|B3|Baseline|Total|Total of all reporting groups
179812|NCT01642277|B2|Baseline|Non-Urinary Urge Incontinence|Sixty (n = 60) women without UUI were evaluated at baseline only (week 0) in order to serve as a control cohort. These women never received study therapy (i.e., 5-10mg daily solifenacin).
179813|NCT01642277|B1|Baseline|Urinary Urge Incontinence|Seventy-four (n = 74) women received 5mg daily solifenacin (with an option to increase to 10mg daily solifenacin at 4 weeks) for the treatment of urinary urge incontinence (UUI).
179814|NCT01642277|P2|Participant Flow|Non-Urinary Urge Incontinence|Sixty (n = 60) women without UUI were evaluated at baseline only (week 0) in order to serve as a control cohort. These women never received study therapy (i.e., 5-10mg daily solifenacin).
179815|NCT01642277|P1|Participant Flow|Urinary Urge Incontinence|Seventy-four (n = 74) women received 5-10mg daily solifenacin for the treatment of urinary urge incontinence (UUI).
179816|NCT01642277|O2|Outcome|Solifenacin Non-Responder|Individuals with urinary urge incontinence who did not respond to solifenacin at 12 weeks
179817|NCT01642277|O1|Outcome|Solifenacin Responder|Individuals with urinary urge incontinence who responded to solifenacin at 12 weeks
179818|NCT01642277|O2|Outcome|Solifenacin Non-Responder|Individuals with urinary urge incontinence who did not respond to solifenacin at 12 weeks
179819|NCT01642277|O1|Outcome|Solifenacin Responder|Individuals with urinary urge incontinence who responded to solifenacin at 12 weeks
179820|NCT01642277|O1|Outcome|Urinary Urge Incontinence|Women who received 5-10mg daily solifenacin for the treatment of urinary urge incontinence (UUI).
179821|NCT01642277|E2|Reported Event|Non-Urinary Urge Incontinence|Sixty (n = 60) women without UUI were evaluated at baseline only (week 0) in order to serve as a control cohort. These women never received study therapy (i.e., 5-10mg daily solifenacin).
179822|NCT01642277|E1|Reported Event|Urinary Urge Incontinence|Seventy-four (n = 74) women received 5-10mg daily solifenacin for the treatment of urinary urge incontinence (UUI).
179823|NCT01642238|B1|Baseline|Antithrombotic Effects|Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) using a randomized, two-treatment, two-period, cross-over design in healthy volunteers.
179824|NCT01642238|P2|Participant Flow|Clopidogrel, Then Ticagrelor|Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week washout period in between.
179825|NCT01642238|P1|Participant Flow|Ticagrelor, Then Clopidogrel|Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week washout period in between.
179826|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
179827|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
179828|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
179829|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
179830|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
179831|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
179832|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
179833|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
179834|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
179835|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
179836|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
179837|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
179838|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
179839|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
179840|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
179841|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
179842|NCT01642238|E2|Reported Event|Clopidogrel, Then Ticagrelor|Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week wash out period in between.
179843|NCT01642238|E1|Reported Event|Ticagrelor, Then Clopidogrel|Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week wash out period in between.
179844|NCT01642212|B3|Baseline|Total|Total of all reporting groups
179845|NCT01642212|B2|Baseline|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179846|NCT01642212|B1|Baseline|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179847|NCT01642212|P5|Participant Flow|Oral Budesonide Suspension (OBS) 2 mg to Open-label OBS 2 mg|During the first 12 weeks of open-label extension treatment, participants took 2 mg OBS (formulation MB-9) once daily (qd) at bedtime. The volume per dose was 10 mL of oral liquid (10 mL qd; 0.2 mg/mL). Thereafter, an optional dose increase to 1.5 mg twice daily (bid) (7.5 mL bid; 0.2 mg/mL) and then to 2 mg bid (10 mL bid; 0.2 mg/mL) was allowed for subjects whose response to the 2 mg once daily dose was inadequate, as determined by the Investigator; a dose decrease to 2 mg once daily was allowed at any time.
179848|NCT01642212|P4|Participant Flow|Placebo to Open-label Oral Budesonide Suspension (OBS) 2 mg|During the first 12 weeks of open-label extension treatment, participants took 2 mg OBS (formulation MB-9) once daily (qd) at bedtime. The volume per dose was 10 mL of oral liquid (10 mL qd; 0.2 mg/mL). Thereafter, an optional dose increase to 1.5 mg twice daily (bid) (7.5 mL bid; 0.2 mg/mL) and then to 2 mg bid (10 mL bid; 0.2 mg/mL) was allowed for subjects whose response to the 2 mg once daily dose was inadequate, as determined by the Investigator; a dose decrease to 2 mg once daily was allowed at any time.
179850|NCT01642212|P2|Participant Flow|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179851|NCT01642212|P1|Participant Flow|Single-blind Placebo|Eligible participants entered a 4-week, single-blind, placebo baseline period. Participants ingested the first dose of placebo in the clinic in the presence of study center personnel, and the remaining doses were ingested at home. Participants took placebo twice daily (bid); once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179852|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179853|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179854|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179855|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179856|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179857|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179858|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179859|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179860|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179861|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179862|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179863|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179864|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179865|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179866|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179867|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179868|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179869|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179870|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179871|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179872|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179873|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179897|NCT01642212|E1|Reported Event|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179874|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179875|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179876|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179877|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179878|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179879|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179880|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179881|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179882|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179883|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179884|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179885|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179886|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179887|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179888|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179889|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179890|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179891|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179892|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179893|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179894|NCT01642212|E4|Reported Event|Oral Budesonide Suspension (OBS) 2 mg to Open-label OBS 2 mg|During the first 12 weeks of open-label extension treatment, participants took 2 mg OBS (formulation MB-9) once daily (qd) at bedtime. The volume per dose was 10 mL of oral liquid (10 mL qd; 0.2 mg/mL). Thereafter, an optional dose increase to 1.5 mg twice daily (bid) (7.5 mL bid; 0.2 mg/mL) and then to 2 mg bid (10 mL bid; 0.2 mg/mL) was allowed for subjects whose response to the 2 mg once daily dose was inadequate, as determined by the Investigator; a dose decrease to 2 mg once daily was allowed at any time.
179895|NCT01642212|E3|Reported Event|Placebo to Open-label Oral Budesonide Suspension (OBS) 2 mg|During the first 12 weeks of open-label extension treatment, participants took 2 mg OBS (formulation MB-9) once daily (qd) at bedtime. The volume per dose was 10 mL of oral liquid (10 mL qd; 0.2 mg/mL). Thereafter, an optional dose increase to 1.5 mg twice daily (bid) (7.5 mL bid; 0.2 mg/mL) and then to 2 mg bid (10 mL bid; 0.2 mg/mL) was allowed for subjects whose response to the 2 mg once daily dose was inadequate, as determined by the Investigator; a dose decrease to 2 mg once daily was allowed at any time.
179896|NCT01642212|E2|Reported Event|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2mg OBS (formulation MB-9) 2 mg twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
179898|NCT01642147|B3|Baseline|Total|Total of all reporting groups
179899|NCT01642147|B2|Baseline|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
179900|NCT01642147|B1|Baseline|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
179901|NCT01642147|P2|Participant Flow|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
179902|NCT01642147|P1|Participant Flow|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
179903|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
179904|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
179905|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
179906|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
179907|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
179908|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
179909|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
179910|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
179911|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
179912|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
179913|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
179914|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
179915|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
179916|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
179917|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
179918|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
179919|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
179920|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
179921|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
179922|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
179923|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
186453|NCT01613417|O2|Outcome|Reader 2|Paired exams reviewed by Reader 2
179924|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
179925|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
179926|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
179927|NCT01642147|E2|Reported Event|Craniotomy Group|Randomly chosen patients undergoing selective craniotomy surgery. Transcranial Doppler measures,jugular venous bulb catheterization, radial artery catheterization, and craniotomy under general anesthesia will be performed.
179928|NCT01642147|E1|Reported Event|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
179929|NCT01642082|B1|Baseline|Treatment (Dalantercept)|"Patients receive dalantercept SC on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Dalantercept: Given SC~Laboratory Biomarker Analysis: Correlative studies"
179930|NCT01642082|P1|Participant Flow|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.~Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.~A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
179931|NCT01642082|O6|Outcome|Grade 5 (CTCAE v 4.0)|Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
179932|NCT01642082|O5|Outcome|Grade 4 (CTCAE v 4.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
179933|NCT01642082|O4|Outcome|Grade 3 (CTCAE v 4.0)|Number of patients who experienced a grade 3 event using Common Terminology version 4.0
179934|NCT01642082|O3|Outcome|Grade 2 (CTCAE v4.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
179935|NCT01642082|O2|Outcome|Grade 1 (CTCAE v4.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
179936|NCT01642082|O1|Outcome|Grade 0|Number of patients who did not experience the specified AE.
179937|NCT01642082|O1|Outcome|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.~Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.~A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
179938|NCT01642082|O1|Outcome|Treatment (Dalantercept)|"Patients receive dalantercept SC on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Dalantercept: Given SC~Laboratory Biomarker Analysis: Correlative studies"
179939|NCT01642082|O1|Outcome|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.~Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.~A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
179940|NCT01642082|O1|Outcome|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.~Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.~A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
179941|NCT01642082|O1|Outcome|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.~Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.~A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
179942|NCT01642082|E1|Reported Event|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.~Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.~A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
179943|NCT01642004|B3|Baseline|Total|Total of all reporting groups
179944|NCT01642004|B2|Baseline|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179945|NCT01642004|B1|Baseline|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
186454|NCT01613417|O1|Outcome|Reader 1|Paired exams reviewed by Reader 1
179946|NCT01642004|P2|Participant Flow|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179947|NCT01642004|P1|Participant Flow|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179948|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179949|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179950|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179951|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179952|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179953|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179954|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179955|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179956|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179957|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179958|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179959|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179960|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179961|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179962|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179963|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179964|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179965|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179966|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179967|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179968|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179969|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179970|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179971|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179972|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179973|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179974|NCT01642004|E2|Reported Event|DOCETAXEL|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179975|NCT01642004|E1|Reported Event|NIVOLUMAB|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
179976|NCT01641991|B5|Baseline|Total|Total of all reporting groups
179977|NCT01641991|B4|Baseline|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
179978|NCT01641991|B3|Baseline|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
179979|NCT01641991|B2|Baseline|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
179980|NCT01641991|B1|Baseline|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
179981|NCT01641991|P4|Participant Flow|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
179982|NCT01641991|P3|Participant Flow|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
179983|NCT01641991|P2|Participant Flow|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
179984|NCT01641991|P1|Participant Flow|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
179985|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
179986|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
179987|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
179988|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
179989|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
179990|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
179991|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
179992|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
179993|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
179994|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
179995|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
179996|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
179997|NCT01641991|O3|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
179998|NCT01641991|O2|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
179999|NCT01641991|O1|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180000|NCT01641991|O3|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180001|NCT01641991|O2|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180002|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
180003|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180004|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180005|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180006|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
180007|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180008|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180009|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180010|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
180011|NCT01641991|O3|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180012|NCT01641991|O2|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180013|NCT01641991|O1|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180014|NCT01641991|O3|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180015|NCT01641991|O2|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180016|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
180017|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180018|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180019|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180020|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
180021|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180022|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180023|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180024|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
180025|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180026|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180027|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180028|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
180029|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180030|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180031|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180032|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
180033|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180034|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180035|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180036|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
181004|NCT01639703|O1|Outcome|CD31 0%|Absence of glutamine synthetase labelling
180037|NCT01641991|O3|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180038|NCT01641991|O2|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180039|NCT01641991|O1|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180040|NCT01641991|O3|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180041|NCT01641991|O2|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180042|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
180043|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180044|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180045|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180046|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
180047|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180048|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180049|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180050|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
180051|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180052|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180053|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180054|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
180055|NCT01641991|E4|Reported Event|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180056|NCT01641991|E3|Reported Event|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180057|NCT01641991|E2|Reported Event|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
180058|NCT01641991|E1|Reported Event|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
180059|NCT01641978|B1|Baseline|Neurologic Level|Neurologic patients
180060|NCT01641978|P1|Participant Flow|Neurologic Level|Neurologic patients
180061|NCT01641978|O1|Outcome|Critical Care Time Experience|Influence of work experience in the evaluation of neurological patients
180062|NCT01641978|O3|Outcome|Slight|patients with GCS > 12 points
180063|NCT01641978|O2|Outcome|Moderate|patients with GCS 9 - 12 points
180064|NCT01641978|O1|Outcome|Severe|patients with GCS < 9 points
180065|NCT01641978|O1|Outcome|Neurologic Level|Neurologic patients
180066|NCT01641978|E1|Reported Event|Neurologic Level|Neurologic patients
180067|NCT01641952|B1|Baseline|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
180068|NCT01641952|P1|Participant Flow|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
180069|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
180070|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
180071|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
180072|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
180073|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
180074|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
180264|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180075|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
180076|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
180077|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
180078|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
180079|NCT01641952|E1|Reported Event|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
180080|NCT01641939|B4|Baseline|Total|Total of all reporting groups
180081|NCT01641939|B3|Baseline|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180082|NCT01641939|B2|Baseline|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180083|NCT01641939|B1|Baseline|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180084|NCT01641939|P3|Participant Flow|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180085|NCT01641939|P2|Participant Flow|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180086|NCT01641939|P1|Participant Flow|Standard Taxane Therapy|Docetaxel was administered at 75 milligram per meter square (mg/m^2) intravenously (IV) on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180087|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180088|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180089|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180090|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180091|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180092|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180093|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180094|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180095|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180096|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180097|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180679|NCT01640951|O2|Outcome|AIN150 FI_AIN300 FI|AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
180098|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180099|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180100|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180101|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180102|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180103|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180104|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180105|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180106|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180107|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180108|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180109|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180110|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180111|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180112|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180113|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180114|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180115|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180116|NCT01641939|O3|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180117|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180158|NCT01641900|B2|Baseline|Group: Healthy Controls|Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. Participants completed both the Drug and Placebo arms.
180118|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180119|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180120|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180121|NCT01641939|E3|Reported Event|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180122|NCT01641939|E2|Reported Event|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180123|NCT01641939|E1|Reported Event|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
180124|NCT01641926|B5|Baseline|Total|Total of all reporting groups
180125|NCT01641926|B4|Baseline|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
180126|NCT01641926|B3|Baseline|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
180127|NCT01641926|B2|Baseline|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
180128|NCT01641926|B1|Baseline|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
180129|NCT01641926|P4|Participant Flow|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
180130|NCT01641926|P3|Participant Flow|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
180131|NCT01641926|P2|Participant Flow|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
180132|NCT01641926|P1|Participant Flow|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
180133|NCT01641926|O4|Outcome|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
180134|NCT01641926|O3|Outcome|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
180135|NCT01641926|O2|Outcome|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
180136|NCT01641926|O1|Outcome|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
180137|NCT01641926|O4|Outcome|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
180138|NCT01641926|O3|Outcome|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
180139|NCT01641926|O2|Outcome|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
180140|NCT01641926|O1|Outcome|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
180141|NCT01641926|O4|Outcome|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
180142|NCT01641926|O3|Outcome|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
180143|NCT01641926|O2|Outcome|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
180144|NCT01641926|O1|Outcome|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
180145|NCT01641926|O4|Outcome|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
180146|NCT01641926|O3|Outcome|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
180147|NCT01641926|O2|Outcome|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
180148|NCT01641926|O1|Outcome|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
180149|NCT01641926|O4|Outcome|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
180150|NCT01641926|O3|Outcome|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
180151|NCT01641926|O2|Outcome|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
180152|NCT01641926|O1|Outcome|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
180153|NCT01641926|E4|Reported Event|HBeAG(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
180154|NCT01641926|E3|Reported Event|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
180155|NCT01641926|E2|Reported Event|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
180156|NCT01641926|E1|Reported Event|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
180157|NCT01641900|B3|Baseline|Total|Total of all reporting groups
180159|NCT01641900|B1|Baseline|Group: Schizophrenia|Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants completed both the Drug and Placebo arms.
180160|NCT01641900|P2|Participant Flow|Group: Healthy Controls|Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. Participants completed both the Drug and Placebo arms.
180161|NCT01641900|P1|Participant Flow|Group: Schizophrenia|Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants completed both the Drug and Placebo arms.
180162|NCT01641900|O2|Outcome|Group: Healthy Controls|Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. Participants completed both the Drug and Placebo arms.
180163|NCT01641900|O1|Outcome|Group: Schizophrenia|Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants completed both the Drug and Placebo arms.
180164|NCT01641900|O2|Outcome|Group: Healthy Controls|Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. Participants completed both the Drug and Placebo arms.
180165|NCT01641900|O1|Outcome|Group: Schizophrenia|Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants completed both the Drug and Placebo arms.
180166|NCT01641900|E4|Reported Event|3mg Eszopiclone Healthy Controls|Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use.Participants who completed Drug Intervention.
180167|NCT01641900|E3|Reported Event|3mg Eszopiclone With Schizophrenia|Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants who completed Drug Intervention.
180168|NCT01641900|E2|Reported Event|Placebo Healthy Controls|Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use.Participants who completed Placebo Intervention.
180169|NCT01641900|E1|Reported Event|Placebo With Schizophrenia|Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants who completed Placebo Intervention.
180170|NCT01641861|B3|Baseline|Total|Total of all reporting groups
180171|NCT01641861|B2|Baseline|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
180172|NCT01641861|B1|Baseline|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
180173|NCT01641861|P2|Participant Flow|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
180174|NCT01641861|P1|Participant Flow|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
180175|NCT01641861|O2|Outcome|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
180176|NCT01641861|O1|Outcome|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
180177|NCT01641861|O2|Outcome|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
180178|NCT01641861|O1|Outcome|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
180179|NCT01641861|O2|Outcome|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
180180|NCT01641861|O1|Outcome|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
180181|NCT01641861|O2|Outcome|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
180182|NCT01641861|O1|Outcome|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
180183|NCT01641861|O2|Outcome|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
180184|NCT01641861|O1|Outcome|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
180185|NCT01641861|E2|Reported Event|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
180186|NCT01641861|E1|Reported Event|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
180187|NCT01641835|B1|Baseline|Normals|No eye disease.
180188|NCT01641835|P1|Participant Flow|Normals|No eye disease.
180189|NCT01641835|O1|Outcome|Healthy Volunteers|Healthy eye without prior intraocular surgery (except cataract surgery and Lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve
180190|NCT01641835|O1|Outcome|Healthy Volunteers|Healthy eye without prior intraocular surgery (except cataract surgery and Lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve
180191|NCT01641835|E1|Reported Event|Normals|No adverse events were reported.
180192|NCT01641822|B3|Baseline|Total|Total of all reporting groups
180193|NCT01641822|B2|Baseline|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
180194|NCT01641822|B1|Baseline|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
180195|NCT01641822|P3|Participant Flow|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
180196|NCT01641822|P2|Participant Flow|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
180197|NCT01641822|P1|Participant Flow|TIS Run-In Treatment Group|Enrolled participants received 28 days of TIS (300 mg 2 times daily) during the run-in phase.
180198|NCT01641822|O2|Outcome|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
180199|NCT01641822|O1|Outcome|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
180200|NCT01641822|O2|Outcome|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
180201|NCT01641822|O1|Outcome|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
180202|NCT01641822|O2|Outcome|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
180203|NCT01641822|O1|Outcome|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
180204|NCT01641822|O2|Outcome|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
180205|NCT01641822|O1|Outcome|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
180206|NCT01641822|O2|Outcome|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
180207|NCT01641822|O1|Outcome|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
180208|NCT01641822|O2|Outcome|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
180209|NCT01641822|O1|Outcome|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
180210|NCT01641822|E3|Reported Event|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
180211|NCT01641822|E2|Reported Event|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
180212|NCT01641822|E1|Reported Event|TIS Run-In Treatment Group|Enrolled participants received 28 days of TIS (300 mg 2 times daily) during the run-in phase.
180213|NCT01641692|B1|Baseline|All Study Treatments|"The treatment phase was comprised of three 14-day treatment periods. Treatment Period 1 and 2 were followed by a 12-14 day washout period. Treatment Period 3 was followed by a 5 to 9 day washout period before the Follow-up visit. Participants were randomly assigned to receive a sequence of 3 of the 8 active treatments :~UMEC 15.6, 31.25, 62.5, 125, 250 µg QD and UMEC 15.6, 31.25 µg BID, placebo."
180214|NCT01641692|P8|Participant Flow|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180215|NCT01641692|P7|Participant Flow|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180216|NCT01641692|P6|Participant Flow|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180217|NCT01641692|P5|Participant Flow|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180218|NCT01641692|P4|Participant Flow|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180219|NCT01641692|P3|Participant Flow|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180220|NCT01641692|P2|Participant Flow|UMEC 15.6 µg QD|Participants received umeclidinium bromide (UMEC) 15.6 micrograms (µg) in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180221|NCT01641692|P1|Participant Flow|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
180222|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180223|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180224|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180225|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180226|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180227|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180228|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180229|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
180230|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180231|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180232|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180233|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180234|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180235|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180236|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180237|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
180238|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180239|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180240|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180241|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180242|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180243|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180244|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180245|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
180246|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180247|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180248|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180249|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180250|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180251|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180252|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180253|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
180254|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180255|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180256|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180257|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180258|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180259|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180260|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180261|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
180262|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180263|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180265|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180266|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180267|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180268|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180269|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
180270|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180271|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180272|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180273|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180274|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180275|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180276|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180277|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
180278|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180279|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180280|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180281|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180282|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180283|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180284|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180285|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
180286|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180287|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180288|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180289|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180290|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180291|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180292|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180293|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
180294|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180295|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180296|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180297|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180298|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180299|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180300|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180301|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
180302|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180303|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180304|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180305|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180306|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180307|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180308|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180309|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
180310|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180311|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180312|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180313|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180314|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180315|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180316|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180317|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
180318|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180319|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180320|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180321|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180322|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180323|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180324|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180325|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
180326|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180327|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180328|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180329|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180330|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180331|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180332|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180333|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
180334|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180335|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180336|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180337|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180338|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180339|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180340|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180341|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
180342|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180343|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180344|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180345|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180346|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180347|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180348|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180349|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
180350|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180351|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180352|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180353|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180354|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180355|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180356|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180357|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
180358|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180359|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180360|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180361|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180362|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180363|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180364|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180365|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
180366|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180367|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180368|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180369|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180370|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180371|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180372|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180373|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
180374|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180375|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180376|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180377|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180378|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180379|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180380|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180381|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
180382|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180383|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180384|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180385|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180386|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180387|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180388|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180389|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
180390|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180391|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180392|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180393|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180394|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180395|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180396|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180397|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
180398|NCT01641692|O1|Outcome|All Study Treatments|The treatment phase was comprised of three 14-day treatment periods. Treatment Period 1 and 2 were followed by a 12-14 day washout period. Treatment Period 3 was followed by a 5 to 9 day washout period before the Follow-up visit. Participants were randomly assigned to receive a sequence of 3 of the 8 active treatments : UMEC 15.6, 31.25, 62.5, 125, 250 µg QD and UMEC 15.6, 31.25 µg BID, placebo.
180399|NCT01641692|E8|Reported Event|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180400|NCT01641692|E7|Reported Event|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
180401|NCT01641692|E6|Reported Event|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180402|NCT01641692|E5|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180403|NCT01641692|E4|Reported Event|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180404|NCT01641692|E3|Reported Event|UMEC 31.5 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180405|NCT01641692|E2|Reported Event|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
180406|NCT01641692|E1|Reported Event|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
180407|NCT01641653|B3|Baseline|Total|Total of all reporting groups
180408|NCT01641653|B2|Baseline|Midazolam|"half of the patients will receive Midazolam prior to entering the OR~Midazolam: 1-2.5 mg"
180409|NCT01641653|B1|Baseline|Placebo|"half of the patients will receive placebo (normal saline) prior to entering the OR~Normal saline: Normal saline 2cc. one dose prior to OR"
180410|NCT01641653|P2|Participant Flow|Midazolam|"half of the patients will receive Midazolam prior to entering the OR~Midazolam: 1-2.5 mg"
180411|NCT01641653|P1|Participant Flow|Placebo|"half of the patients will receive placebo (normal saline 2mL) prior to entering the OR~Normal saline: Normal saline 2cc. one dose prior to OR"
180412|NCT01641653|O2|Outcome|Midazolam|subjects will receive midazolam 1.5-2mg prior to entering the OR
180413|NCT01641653|O1|Outcome|Placebo|subjects will receive 2cc. Normal Saline prior to entering the OR
180414|NCT01641653|O2|Outcome|Midazolam|half of subjects will receive Midazolam: 1-2.5 mgIV prior to entering the OR
180415|NCT01641653|O1|Outcome|Placebo|Normal saline: Normal saline 2cc. IV one dose prior to OR
180416|NCT01641653|O2|Outcome|Midazolam|One half of subjects will recieveMidazolam: 1-2.5 mg IV
180417|NCT01641653|O1|Outcome|Placebo|Normal saline: Normal saline 2cc. IV one dose prior to OR
180418|NCT01641653|E2|Reported Event|Midazolam|"half of the patients will receive Midazolam prior to entering the OR~Midazolam: 1-2.5 mg"
180419|NCT01641653|E1|Reported Event|Placebo|"half of the patients will receive placebo (normal saline) prior to entering the OR~Normal saline: Normal saline 2cc. one dose prior to OR"
180420|NCT01641640|B1|Baseline|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
180421|NCT01641640|P1|Participant Flow|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+pegylated interferon alfa 2a (PEG)+ribavirin (RBV) for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
180422|NCT01641640|O1|Outcome|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
180423|NCT01641640|O1|Outcome|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
180424|NCT01641640|O1|Outcome|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
180425|NCT01641640|O1|Outcome|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
180426|NCT01641640|O1|Outcome|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
180427|NCT01641640|O1|Outcome|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
180428|NCT01641640|E1|Reported Event|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
180429|NCT01641471|B3|Baseline|Total|Total of all reporting groups
180446|NCT01641367|B5|Baseline|Experimental: Cohort C|"Under Protocol version 1.0:~Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV~Changed under LOA#2:~Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure~• Best available NRTIs, RAL, and DRV/RTV"
180570|NCT01641081|P2|Participant Flow|Sequence 2|12 μg Foradil Aerolizer; Formoterol 12 μg Pressair; 24 μg Foradil Aerolizer; Formoterol 6 μg Pressair; Placebo Pressair
180430|NCT01641471|B2|Baseline|Placebo TENS|"Placebo TENS in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.~Placebo EMPI Select TENS: Sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation (even though screen shows 0-60 milliamps of output current). The 4 electrodes will be focused on the posterior aspect of the knee during immediate postoperative period and lasting through discharge from the hospital. Once patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes"
180431|NCT01641471|B1|Baseline|Active TENS|"Active TENS in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.~EMPI Select TENS: The unit is capable of 0-60 milliamps of output current. The 4 electrodes will be focused on the posterior aspect of the knee during the immediate postoperative period and lasting through discharge from the hospital. Once the patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes off, as needed. Amount of TENS usage and average intensity used will be recorded. An assessment of blinding will be conducted at the conclusion of the study by asking patients what treatment arm they think that they received."
180432|NCT01641471|P2|Participant Flow|Placebo TENS|"Placebo TENS in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.~Placebo EMPI Select TENS: Sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation (even though screen shows 0-60 milliamps of output current). The 4 electrodes will be focused on the posterior aspect of the knee during immediate postoperative period and lasting through discharge from the hospital. Once patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes"
180433|NCT01641471|P1|Participant Flow|Active TENS|"Active TENS in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.~EMPI Select TENS: The unit is capable of 0-60 milliamps of output current. The 4 electrodes will be focused on the posterior aspect of the knee during the immediate postoperative period and lasting through discharge from the hospital. Once the patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes off, as needed. Amount of TENS usage and average intensity used will be recorded. An assessment of blinding will be conducted at the conclusion of the study by asking patients what treatment arm they think that they received."
180434|NCT01641471|O2|Outcome|Placebo TENS|"Placebo TENS in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.~Placebo EMPI Select TENS: Sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation (even though screen shows 0-60 milliamps of output current). The 4 electrodes will be focused on the posterior aspect of the knee during immediate postoperative period and lasting through discharge from the hospital. Once patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes"
180435|NCT01641471|O1|Outcome|Active TENS|"Active TENS in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.~EMPI Select TENS: The unit is capable of 0-60 milliamps of output current. The 4 electrodes will be focused on the posterior aspect of the knee during the immediate postoperative period and lasting through discharge from the hospital. Once the patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes off, as needed. Amount of TENS usage and average intensity used will be recorded. An assessment of blinding will be conducted at the conclusion of the study by asking patients what treatment arm they think that they received."
180436|NCT01641471|O2|Outcome|Placebo TENS|"Placebo TENS in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.~Placebo EMPI Select TENS: Sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation (even though screen shows 0-60 milliamps of output current). The 4 electrodes will be focused on the posterior aspect of the knee during immediate postoperative period and lasting through discharge from the hospital. Once patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes"
180447|NCT01641367|B4|Baseline|Experimental: Sub-cohort B3|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)~• RAL, DRV/RTV, and FTC/TDF or TDF+3TC"
180437|NCT01641471|O1|Outcome|Active TENS|"Active TENS in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.~EMPI Select TENS: The unit is capable of 0-60 milliamps of output current. The 4 electrodes will be focused on the posterior aspect of the knee during the immediate postoperative period and lasting through discharge from the hospital. Once the patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes off, as needed. Amount of TENS usage and average intensity used will be recorded. An assessment of blinding will be conducted at the conclusion of the study by asking patients what treatment arm they think that they received."
180438|NCT01641471|O2|Outcome|Placebo TENS|"Placebo TENS in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.~Placebo EMPI Select TENS: Sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation (even though screen shows 0-60 milliamps of output current). The 4 electrodes will be focused on the posterior aspect of the knee during immediate postoperative period and lasting through discharge from the hospital. Once patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes"
180439|NCT01641471|O1|Outcome|Active TENS|"Active TENS in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.~EMPI Select TENS: The unit is capable of 0-60 milliamps of output current. The 4 electrodes will be focused on the posterior aspect of the knee during the immediate postoperative period and lasting through discharge from the hospital. Once the patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes off, as needed. Amount of TENS usage and average intensity used will be recorded. An assessment of blinding will be conducted at the conclusion of the study by asking patients what treatment arm they think that they received."
180440|NCT01641471|O2|Outcome|Placebo TENS|"Placebo TENS in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.~Placebo EMPI Select TENS: Sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation (even though screen shows 0-60 milliamps of output current). The 4 electrodes will be focused on the posterior aspect of the knee during immediate postoperative period and lasting through discharge from the hospital. Once patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes"
180441|NCT01641471|O1|Outcome|Active TENS|"Active TENS in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.~EMPI Select TENS: The unit is capable of 0-60 milliamps of output current. The 4 electrodes will be focused on the posterior aspect of the knee during the immediate postoperative period and lasting through discharge from the hospital. Once the patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes off, as needed. Amount of TENS usage and average intensity used will be recorded. An assessment of blinding will be conducted at the conclusion of the study by asking patients what treatment arm they think that they received."
180442|NCT01641471|E2|Reported Event|Placebo TENS|"Placebo TENS in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.~Placebo EMPI Select TENS: Sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation (even though screen shows 0-60 milliamps of output current). The 4 electrodes will be focused on the posterior aspect of the knee during immediate postoperative period and lasting through discharge from the hospital. Once patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes"
180443|NCT01641471|E1|Reported Event|Active TENS|"Active TENS in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.~EMPI Select TENS: The unit is capable of 0-60 milliamps of output current. The 4 electrodes will be focused on the posterior aspect of the knee during the immediate postoperative period and lasting through discharge from the hospital. Once the patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes off, as needed. Amount of TENS usage and average intensity used will be recorded. An assessment of blinding will be conducted at the conclusion of the study by asking patients what treatment arm they think that they received."
180444|NCT01641367|B7|Baseline|Total|Total of all reporting groups
180445|NCT01641367|B6|Baseline|Experimental: Cohort D|"Under Protocol version 1.0:~Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:~• Best available regimen, including study-provided and any locally available drugs~Changed under LOA#2:~Not eligible for Cohort A, B, or C:~• Best available regimen, including study-provided and any locally available drugs~Updated under protocol v2.0:~• Best available ART regimen, including study-provided and any locally available non-experimental drugs"
180664|NCT01640951|B1|Baseline|AIN150FI|AIN457 150 mg - Fixed Interval (FI)
180448|NCT01641367|B3|Baseline|Experimental: Sub-cohort B2|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)~• ETR, RAL, and DRV/RTV"
180449|NCT01641367|B2|Baseline|Experimental: Sub-cohort B1|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, & DRV/RTV~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)~• Best available NRTIs, RAL, & DRV/RTV"
180450|NCT01641367|B1|Baseline|Experimental: Cohort A|"Under Protocol version 1.0:~No resistance to NRTIs, PIs, or NNRTI~• Continue current second-line regimen; NRTIs could be modified~Changed under LOA#2 to:~No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified~Changed under LOA#3 to:~No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure~• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued."
180451|NCT01641367|P6|Participant Flow|Experimental: Cohort D|"Under Protocol version 1.0:~Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:~• Best available regimen, including study-provided and any locally available drugs~Changed under LOA#2:~Not eligible for Cohort A, B, or C:~• Best available regimen, including study-provided and any locally available drugs~Updated under protocol v2.0:~• Best available ART regimen, including study-provided and any locally available non-experimental drugs"
180452|NCT01641367|P5|Participant Flow|Experimental: Cohort C|"Under Protocol version 1.0:~Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV~Changed under LOA#2:~Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure~• Best available NRTIs, RAL, and DRV/RTV"
180453|NCT01641367|P4|Participant Flow|Experimental: Sub-cohort B3|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)~• RAL, DRV/RTV, and FTC/TDF or TDF+3TC"
180454|NCT01641367|P3|Participant Flow|Experimental: Sub-cohort B2|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)~• ETR, RAL, and DRV/RTV"
180455|NCT01641367|P2|Participant Flow|Experimental: Sub-cohort B1|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, & DRV/RTV~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)~• Best available NRTIs, RAL, & DRV/RTV"
180456|NCT01641367|P1|Participant Flow|Experimental: Cohort A|"Under Protocol version 1.0:~No resistance to NRTIs, PIs, or NNRTI~• Continue current second-line regimen; NRTIs could be modified~Changed under LOA#2 to:~No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified~Changed under LOA#3 to:~No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure~• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued."
180457|NCT01641367|O7|Outcome|Experimental: Cohort D|"Under Protocol version 1.0:~Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:~• Best available regimen, including study-provided and any locally available drugs~Changed under LOA#2:~Not eligible for Cohort A, B, or C:~• Best available regimen, including study-provided and any locally available drugs~Updated under protocol v2.0:~• Best available ART regimen, including study-provided and any locally available non-experimental drugs"
180458|NCT01641367|O6|Outcome|Experimental: Cohort C|"Under Protocol version 1.0:~Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV~Changed under LOA#2:~Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure~• Best available NRTIs, RAL, and DRV/RTV"
180459|NCT01641367|O5|Outcome|Experimental: Sub-cohort B3|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)~• RAL, DRV/RTV, and FTC/TDF or TDF+3TC"
180665|NCT01640951|P8|Participant Flow|AIN300 OL|AIN457 300 mg Open-label (OL)
180460|NCT01641367|O4|Outcome|Experimental: Sub-cohort B2|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)~• ETR, RAL, and DRV/RTV"
180461|NCT01641367|O3|Outcome|Experimental: Sub-cohort B1|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, & DRV/RTV~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)~• Best available NRTIs, RAL, & DRV/RTV"
180462|NCT01641367|O2|Outcome|Experimental: Cohort A|"Under Protocol version 1.0:~No resistance to NRTIs, PIs, or NNRTI~• Continue current second-line regimen; NRTIs could be modified~Changed under LOA#2 to:~No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified~Changed under LOA#3 to:~No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure~• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued."
180463|NCT01641367|O1|Outcome|Overall Study|Entire enrolled population spanning all arms and interventions.
180464|NCT01641367|E6|Reported Event|Experimental: Cohort D|"Under Protocol version 1.0:~Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:~• Best available regimen, including study-provided and any locally available drugs~Changed under LOA#2:~Not eligible for Cohort A, B, or C:~• Best available regimen, including study-provided and any locally available drugs~Updated under protocol v2.0:~• Best available ART regimen, including study-provided and any locally available non-experimental drugs"
180465|NCT01641367|E5|Reported Event|Experimental: Cohort C|"Under Protocol version 1.0:~Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV~Changed under LOA#2:~Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure~• Best available NRTIs, RAL, and DRV/RTV"
180466|NCT01641367|E4|Reported Event|Experimental: Sub-cohort B3|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)~• RAL, DRV/RTV, and FTC/TDF or TDF+3TC"
180467|NCT01641367|E3|Reported Event|Experimental: Sub-cohort B2|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)~• ETR, RAL, and DRV/RTV"
180468|NCT01641367|E2|Reported Event|Experimental: Sub-cohort B1|"Under Protocol version 1.0:~Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, & DRV/RTV~Changed under LOA#2 to:~Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)~• Best available NRTIs, RAL, & DRV/RTV"
180469|NCT01641367|E1|Reported Event|Experimental: Cohort A|"Under Protocol version 1.0:~No resistance to NRTIs, PIs, or NNRTI~• Continue current second-line regimen; NRTIs could be modified~Changed under LOA#2 to:~No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified~Changed under LOA#3 to:~No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure~• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued."
180470|NCT01641237|B1|Baseline|All Randomized Participants|All randomized participants who received at least one dose of the study treatments.
180471|NCT01641237|P4|Participant Flow|Placebo Dentifrice (0ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
180472|NCT01641237|P3|Participant Flow|NaF Dentifrice (250ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
180473|NCT01641237|P2|Participant Flow|NaF Dentifrice (1150ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
180474|NCT01641237|P1|Participant Flow|Sodium Fluoride (NaF) Dentifrice,1426 Parts Per Million(Ppm)F|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 grams (g) ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
180475|NCT01641237|O4|Outcome|Placebo Dentifrice (0 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
180476|NCT01641237|O3|Outcome|NaF Dentifrice (250 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
180477|NCT01641237|O2|Outcome|NaF Dentifrice (1150 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
180478|NCT01641237|O1|Outcome|NaF Dentifrice (1426 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
180479|NCT01641237|O4|Outcome|Placebo Dentifrice (0 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
180480|NCT01641237|O3|Outcome|NaF Dentifrice (250 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
180481|NCT01641237|O2|Outcome|NaF Dentifrice (1150 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
180482|NCT01641237|O1|Outcome|NaF Dentifrice (1426 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
180483|NCT01641237|O4|Outcome|Placebo Dentifrice (0 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
180484|NCT01641237|O3|Outcome|NaF Dentifrice (250 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
180485|NCT01641237|O2|Outcome|NaF Dentifrice (1150 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
180486|NCT01641237|O1|Outcome|NaF Dentifrice (1426 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
180487|NCT01641237|O4|Outcome|Placebo Dentifrice (0 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
180488|NCT01641237|O3|Outcome|NaF Dentifrice (250 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
180489|NCT01641237|O2|Outcome|NaF Dentifrice (1150 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
180490|NCT01641237|O1|Outcome|NaF Dentifrice (1426 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
180491|NCT01641237|E4|Reported Event|Placebo Dentifrice (0 ppmF)|Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated.
180492|NCT01641237|E3|Reported Event|NaF Dentifrice (250 ppmF)|Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated.
180493|NCT01641237|E2|Reported Event|NaF Dentifrice (1150 ppmF)|Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated.
180494|NCT01641237|E1|Reported Event|NaF Dentifrice (1426 ppmF)|Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated.
180495|NCT01641159|B3|Baseline|Total|Total of all reporting groups
180496|NCT01641159|B2|Baseline|Placebo Plus TAU|"Placebo taken daily for the 15-week active study~Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets."
180517|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
180497|NCT01641159|B1|Baseline|Buspirone Plus TAU|"Buspirone titrated to 60 mg/day for the 15-week active study~Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated."
180498|NCT01641159|P2|Participant Flow|Placebo Plus TAU|"Placebo taken daily for the 15-week active study~Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets."
180499|NCT01641159|P1|Participant Flow|Buspirone Plus TAU|"Buspirone titrated to 60 mg/day for the 15-week active study~Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated."
180500|NCT01641159|O2|Outcome|Placebo Plus TAU|"Placebo taken daily for the 15-week active study~Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets."
180501|NCT01641159|O1|Outcome|Buspirone Plus TAU|"Buspirone titrated to 60 mg/day for the 15-week active study~Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated."
180502|NCT01641159|O2|Outcome|Placebo Plus TAU|"Placebo taken daily for the 15-week active study~Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets."
180503|NCT01641159|O1|Outcome|Buspirone Plus TAU|"Buspirone titrated to 60 mg/day for the 15-week active study~Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated."
180504|NCT01641159|E2|Reported Event|Placebo Plus TAU|"Placebo taken daily for the 15-week active study~Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets."
180505|NCT01641159|E1|Reported Event|Buspirone Plus TAU|"Buspirone titrated to 60 mg/day for the 15-week active study~Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated."
180506|NCT01641133|B4|Baseline|Total|Total of all reporting groups
180507|NCT01641133|B3|Baseline|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180508|NCT01641133|B2|Baseline|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
180509|NCT01641133|B1|Baseline|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180510|NCT01641133|P3|Participant Flow|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180511|NCT01641133|P2|Participant Flow|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
180512|NCT01641133|P1|Participant Flow|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180513|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180514|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
180515|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180516|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180518|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180519|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180520|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
180521|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180522|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180523|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
180524|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180525|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180526|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
180527|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180528|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180529|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
180530|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180531|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180532|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
180533|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180534|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180535|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
180536|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180537|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180569|NCT01641081|P3|Participant Flow|Sequence 3|Formoterol 12 μg Pressair; Formoterol 6 μg Pressair; 12 μg Foradil Aerolizer; Placebo Pressair; 24 μg Foradil Aerolizer
180538|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
180539|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180540|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180541|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
180542|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180543|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180544|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
180545|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180546|NCT01641133|E3|Reported Event|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180547|NCT01641133|E2|Reported Event|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
180548|NCT01641133|E1|Reported Event|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
180549|NCT01641120|B1|Baseline|All Study Participants|Avonex: Intramuscular injection administered using 30 gauge or 25 gauge needle
180550|NCT01641120|P1|Participant Flow|25 Gauge or 30 Gauge Needle|Avonex: Intramuscular injection administered using 25 gauge needle weeks 1, 4, and 5 and 30 gauge needle on weeks 2 and 3.
180551|NCT01641120|O2|Outcome|30 Gauge|Subjects used a 30 gauge needle for intramuscular injection of Avonex on weeks 2 and 3 of the study.
180552|NCT01641120|O1|Outcome|25 Gauge|Subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.
180553|NCT01641120|O2|Outcome|30 Gauge|Subjects used a 30 gauge needle for intramuscular injection of Avonex on weeks 2 and 3 of the study.
180554|NCT01641120|O1|Outcome|25 Gauge|Subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.
180555|NCT01641120|O2|Outcome|30 Gauge|Subjects used a 30 gauge needle for intramuscular injection of Avonex on weeks 2 and 3 of the study.
180556|NCT01641120|O1|Outcome|25 Gauge|Subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.
180557|NCT01641120|O2|Outcome|30 Gauge|Subjects used a 30 gauge needle for intramuscular injection of Avonex for weeks 2 and 3 of the study.
180558|NCT01641120|O1|Outcome|25 Gauge|Subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.
180559|NCT01641120|E2|Reported Event|30 Gauge|Subjects used a 30 gauge needle for intramuscular injection of Avonex on weeks 2 and 3 of the study.
180560|NCT01641120|E1|Reported Event|25 Gauge|The same subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.
180561|NCT01641081|B1|Baseline|Overall Study Population|All patients participating in the crossover study
180562|NCT01641081|P10|Participant Flow|Sequence 10|Formoterol 12 μg Pressair; 12 μg Foradil Aerolizer; Formoterol 6 μg Pressair; 24 μg Foradil Aerolizer; Placebo Pressair
180563|NCT01641081|P9|Participant Flow|Sequence 9|12 μg Foradil Aerolizer; 24 μg Foradil Aerolizer; Formoterol 12 μg Pressair; Placebo Pressair; Formoterol 6 μg Pressair
180564|NCT01641081|P8|Participant Flow|Sequence 8|24 μg Foradil Aerolizer; Placebo Pressair; 12 μg Foradil Aerolizer; Formoterol 6 μg Pressair; Formoterol 12 μg Pressair
180565|NCT01641081|P7|Participant Flow|Sequence 7|Placebo Pressair; Formoterol 6 μg Pressair; 24 μg Foradil Aerolizer; Formoterol 12 μg Pressair; 12 μg Foradil Aerolizer
180566|NCT01641081|P6|Participant Flow|Sequence 6|Formoterol 6 μg Pressair; Formoterol 12 μg Pressair; Placebo Pressair; 12 μg Foradil Aerolizer; 24 μg Foradil Aerolizer
180567|NCT01641081|P5|Participant Flow|Sequence 5|Placebo Pressair; 24 μg Foradil Aerolizer; Formoterol 6 μg Pressair; 12 μg Foradil Aerolizer; Formoterol 12 μg Pressair
180568|NCT01641081|P4|Participant Flow|Sequence 4|Formoterol 6 μg Pressair; Placebo Pressair; Formoterol 12 μg Pressair; 24 μg Foradil Aerolizer; 12 μg Foradil Aerolizer
180680|NCT01640951|O1|Outcome|AIN150FI|AIN457 150 mg - Fixed Interval (FI)
180571|NCT01641081|P1|Participant Flow|Sequence 1|24 μg Foradil Aerolizer; 12 μg Foradil Aerolizer; Placebo Pressair; Formoterol 12 μg Pressair; Formoterol 6 μg Pressair
180572|NCT01641081|O5|Outcome|Placebo|Administered via Pressair
180573|NCT01641081|O4|Outcome|Formoterol 6 μg|Administered via Pressair
180574|NCT01641081|O3|Outcome|Formoterol 12 μg|Administered via Pressair
180575|NCT01641081|O2|Outcome|Foradil 12 μg|Administered via Aerolizer
180576|NCT01641081|O1|Outcome|Foradil 24 μg|Administered via Aerolizer
180577|NCT01641081|O5|Outcome|Placebo|Administered via Pressair
180578|NCT01641081|O4|Outcome|Formoterol 6 μg|Administered via Pressair
180579|NCT01641081|O3|Outcome|Formoterol 12 μg|Administered via Pressair
180580|NCT01641081|O2|Outcome|Foradil 12 μg|Administered via Aerolizer
180581|NCT01641081|O1|Outcome|Foradil 24 μg|Administered via Aerolizer
180582|NCT01641081|E5|Reported Event|Placebo|Administered via Pressair
180583|NCT01641081|E4|Reported Event|Formoterol 6 μg|Administered via Pressair
180584|NCT01641081|E3|Reported Event|Formoterol 12 μg|Administered via Pressair
180585|NCT01641081|E2|Reported Event|Foradil 12 μg|Administered via Aerolizer
180586|NCT01641081|E1|Reported Event|Foradil 24 μg|Administered via Aerolizer
180587|NCT01641042|B3|Baseline|Total|Total of all reporting groups
180588|NCT01641042|B2|Baseline|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180589|NCT01641042|B1|Baseline|Nimenrix At-Risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180590|NCT01641042|P2|Participant Flow|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180591|NCT01641042|P1|Participant Flow|Nimenrix At-Risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180592|NCT01641042|O2|Outcome|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180593|NCT01641042|O1|Outcome|Nimenrix At-Risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180594|NCT01641042|O2|Outcome|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180595|NCT01641042|O1|Outcome|Nimenrix At-Risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180596|NCT01641042|O2|Outcome|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180597|NCT01641042|O1|Outcome|Nimenrix At-Risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180598|NCT01641042|O2|Outcome|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180599|NCT01641042|O1|Outcome|Nimenrix At-Risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180600|NCT01641042|O2|Outcome|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180666|NCT01640951|P7|Participant Flow|AIN300 SoR _ AIN300 FI|AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
180667|NCT01640951|P6|Participant Flow|AIN300 SoR|AIN457 300 mg - Start of Relapse (SoR)
180681|NCT01640951|O8|Outcome|AIN300 OL|AIN457 300 mg Open-label (OL)
180601|NCT01641042|O1|Outcome|Nimenrix At-Risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180602|NCT01641042|O2|Outcome|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180603|NCT01641042|O1|Outcome|Nimenrix At-Risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180604|NCT01641042|O2|Outcome|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180605|NCT01641042|O1|Outcome|Nimenrix At-Risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180606|NCT01641042|O2|Outcome|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180607|NCT01641042|O1|Outcome|Nimenrix At-Risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180608|NCT01641042|O2|Outcome|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180609|NCT01641042|O1|Outcome|Nimenrix At-Risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180610|NCT01641042|O2|Outcome|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180611|NCT01641042|O1|Outcome|Nimenrix At-Risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180612|NCT01641042|O2|Outcome|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180613|NCT01641042|O1|Outcome|Nimenrix At-Risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180614|NCT01641042|O2|Outcome|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180615|NCT01641042|O1|Outcome|Nimenrix At-Risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180616|NCT01641042|O2|Outcome|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180617|NCT01641042|O1|Outcome|Nimenrix At-Risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180668|NCT01640951|P5|Participant Flow|AIN150 SOR_AIN300 FI|AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
180618|NCT01641042|O2|Outcome|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180619|NCT01641042|O1|Outcome|Nimenrix At-Risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180620|NCT01641042|O2|Outcome|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180621|NCT01641042|O1|Outcome|Nimenrix At-Risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180622|NCT01641042|O2|Outcome|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180623|NCT01641042|O1|Outcome|Nimenrix At-Risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180624|NCT01641042|O2|Outcome|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180625|NCT01641042|O1|Outcome|Nimenrix At-Risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180626|NCT01641042|O2|Outcome|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180627|NCT01641042|O1|Outcome|Nimenrix At-Risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180628|NCT01641042|O2|Outcome|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180629|NCT01641042|O1|Outcome|Nimenrix At-Risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180630|NCT01641042|O2|Outcome|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180631|NCT01641042|O1|Outcome|Nimenrix At-Risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180632|NCT01641042|O2|Outcome|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180633|NCT01641042|O1|Outcome|Nimenrix At-Risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180634|NCT01641042|E2|Reported Event|Nimenrix Healthy Group|Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180669|NCT01640951|P4|Participant Flow|AIN150 SoR|AIN457 150 mg - Start of Relapse (SoR)
180670|NCT01640951|P3|Participant Flow|AIN300 FI|AIN457 300 mg - Fixed Interval (FI)
186761|NCT01612702|P2|Participant Flow|Control|No dexamethasone
180635|NCT01641042|E1|Reported Event|Nimenrix At-risk Group|Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
180636|NCT01640964|B4|Baseline|Total|Total of all reporting groups
180637|NCT01640964|B3|Baseline|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
180638|NCT01640964|B2|Baseline|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
180639|NCT01640964|B1|Baseline|Part A: Terlipressin Acetate|Patients received terlipressin acetate 2 mg intravenous (IV) bolus injection.
180640|NCT01640964|P3|Participant Flow|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
180641|NCT01640964|P2|Participant Flow|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
180642|NCT01640964|P1|Participant Flow|Part A: Terlipressin Acetate|Patients received terlipressin acetate 2 mg intravenous (IV) bolus injection.
180643|NCT01640964|O2|Outcome|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
180644|NCT01640964|O1|Outcome|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
180645|NCT01640964|O1|Outcome|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
180646|NCT01640964|O1|Outcome|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
180647|NCT01640964|O1|Outcome|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
180648|NCT01640964|O1|Outcome|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
180649|NCT01640964|O1|Outcome|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
180650|NCT01640964|O1|Outcome|Part A: Terlipressin Acetate|Patients received terlipressin acetate 2 mg intravenous (IV) bolus injection.
180651|NCT01640964|O1|Outcome|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
180652|NCT01640964|O1|Outcome|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
180653|NCT01640964|E3|Reported Event|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
180654|NCT01640964|E2|Reported Event|Part A: Terlipressin Acetate|Patients received terlipressin acetate 2 mg intravenous (IV) bolus injection.
180655|NCT01640964|E1|Reported Event|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
180656|NCT01640951|B9|Baseline|Total|Total of all reporting groups
180657|NCT01640951|B8|Baseline|AIN300 OL|AIN457 300 mg Open-label (OL)
180658|NCT01640951|B7|Baseline|AIN300 SoR _ AIN300 FI|AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
180659|NCT01640951|B6|Baseline|AIN300 SoR|AIN457 300 mg - Start of Relapse (SoR)
180660|NCT01640951|B5|Baseline|AIN150 SOR_AIN300 FI|AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
180661|NCT01640951|B4|Baseline|AIN150 SoR|AIN457 150 mg - Start of Relapse (SoR)
180662|NCT01640951|B3|Baseline|AIN300 FI|AIN457 300 mg - Fixed Interval (FI)
180663|NCT01640951|B2|Baseline|AIN150 FI_AIN300 FI|AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
180682|NCT01640951|O7|Outcome|AIN300 SoR _ AIN300 FI|AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
180683|NCT01640951|O6|Outcome|AIN300 SoR|AIN457 300 mg - Start of Relapse (SoR)
180684|NCT01640951|O5|Outcome|AIN150 SOR_AIN300 FI|AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
180685|NCT01640951|O4|Outcome|AIN150 SoR|AIN457 150 mg - Start of Relapse (SoR)
180686|NCT01640951|O3|Outcome|AIN300 FI|AIN457 300 mg - Fixed Interval (FI)
180687|NCT01640951|O2|Outcome|AIN150 FI_AIN300 FI|AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
180688|NCT01640951|O1|Outcome|AIN150FI|AIN457 150 mg - Fixed Interval (FI)
180689|NCT01640951|O8|Outcome|AIN300 OL|AIN457 300 mg Open-label (OL)
180690|NCT01640951|O7|Outcome|AIN300 SoR _ AIN300 FI|AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
180691|NCT01640951|O6|Outcome|AIN300 SoR|AIN457 300 mg - Start of Relapse (SoR)
180692|NCT01640951|O5|Outcome|AIN150 SOR_AIN300 FI|AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
180693|NCT01640951|O4|Outcome|AIN150 SoR|AIN457 150 mg - Start of Relapse (SoR)
180694|NCT01640951|O3|Outcome|AIN300 FI|AIN457 300 mg - Fixed Interval (FI)
180695|NCT01640951|O2|Outcome|AIN150 FI_AIN300 FI|AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
180696|NCT01640951|O1|Outcome|AIN150FI|AIN457 150 mg - Fixed Interval (FI)
180697|NCT01640951|O9|Outcome|AIN300 OL|AIN457 300 mg Open-label (OL)
180698|NCT01640951|O8|Outcome|AIN300 SoR _ AIN300 FI|AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
180699|NCT01640951|O7|Outcome|AIN300 SoR|AIN457 300 mg - Start of Relapse (SoR)
180700|NCT01640951|O6|Outcome|AIN150 SOR_AIN300 FI|AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
180701|NCT01640951|O5|Outcome|AIN150 SoR|AIN457 150 mg - Start of Relapse (SoR)
180702|NCT01640951|O4|Outcome|AIN300 FI|AIN457 300 mg - Fixed Interval (FI)
180703|NCT01640951|O3|Outcome|AIN150FI (NSW+SW)|AIN457 150 mg - Fixed Interval combined non-switch and switch
180704|NCT01640951|O2|Outcome|AIN150 FI_AIN300 FI|AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
180705|NCT01640951|O1|Outcome|AIN150FI|AIN457 150 mg - Fixed Interval (FI)
180706|NCT01640951|O9|Outcome|AIN300 OL|AIN457 300 mg Open-label (OL)
180707|NCT01640951|O8|Outcome|AIN300 SoR _ AIN300 FI|AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
180708|NCT01640951|O7|Outcome|AIN300 SoR|AIN457 300 mg - Start of Relapse (SoR)
180709|NCT01640951|O6|Outcome|AIN150 SOR_AIN300 FI|AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
180710|NCT01640951|O5|Outcome|AIN150 SoR|AIN457 150 mg - Start of Relapse (SoR)
180711|NCT01640951|O4|Outcome|AIN300 FI|AIN457 300 mg - Fixed Interval (FI)
180712|NCT01640951|O3|Outcome|AIN150FI (NSW+SW)|AIN457 150 mg - Fixed Interval combined non-switch and switch
180713|NCT01640951|O2|Outcome|AIN150 FI_AIN300 FI|AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
180714|NCT01640951|O1|Outcome|AIN150FI|AIN457 150 mg - Fixed Interval (FI)
180715|NCT01640951|O9|Outcome|AIN300 OL|AIN457 300 mg Open-label (OL)
180716|NCT01640951|O8|Outcome|AIN300 SoR _ AIN300 FI|AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
180717|NCT01640951|O7|Outcome|AIN300 SoR|AIN457 300 mg - Start of Relapse (SoR)
180718|NCT01640951|O6|Outcome|AIN150 SOR_AIN300 FI|AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
180719|NCT01640951|O5|Outcome|AIN150 SoR|AIN457 150 mg - Start of Relapse (SoR)
180720|NCT01640951|O4|Outcome|AIN300 FI|AIN457 300 mg - Fixed Interval (FI)
180721|NCT01640951|O3|Outcome|AIN150FI (NSW+SW)|AIN457 150 mg - Fixed Interval combined non-switch and switch
180722|NCT01640951|O2|Outcome|AIN150 FI_AIN300 FI|AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
180723|NCT01640951|O1|Outcome|AIN150FI|AIN457 150 mg - Fixed Interval (FI)
180724|NCT01640951|O9|Outcome|AIN300 OL|AIN457 300 mg Open-label (OL)
180725|NCT01640951|O8|Outcome|AIN300 SoR _ AIN300 FI|AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
180726|NCT01640951|O7|Outcome|AIN300 SoR|AIN457 300 mg - Start of Relapse (SoR)
180727|NCT01640951|O6|Outcome|AIN150 SOR_AIN300 FI|AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
180728|NCT01640951|O5|Outcome|AIN150 SoR|AIN457 150 mg - Start of Relapse (SoR)
180729|NCT01640951|O4|Outcome|AIN300 FI|AIN457 300 mg - Fixed Interval (FI)
180730|NCT01640951|O3|Outcome|AIN150FI (NSW+SW)|AIN457 150 mg - Fixed Interval combined non-switch and switch
180731|NCT01640951|O2|Outcome|AIN150 FI_AIN300 FI|AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
180732|NCT01640951|O1|Outcome|AIN150FI|AIN457 150 mg - Fixed Interval (FI)
180733|NCT01640951|O9|Outcome|AIN300 OL|AIN457 300 mg Open-label (OL)
180734|NCT01640951|O8|Outcome|AIN300 SoR _ AIN300 FI|AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
180735|NCT01640951|O7|Outcome|AIN300 SoR|AIN457 300 mg - Start of Relapse (SoR)
180736|NCT01640951|O6|Outcome|AIN150 SOR_AIN300 FI|AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
180737|NCT01640951|O5|Outcome|AIN150 SoR|AIN457 150 mg - Start of Relapse (SoR)
180738|NCT01640951|O4|Outcome|AIN300 FI|AIN457 300 mg - Fixed Interval (FI)
180739|NCT01640951|O3|Outcome|AIN150FI (NSW+SW)|AIN457 150 mg - Fixed Interval combined non-switch and switch
180740|NCT01640951|O2|Outcome|AIN150 FI_AIN300 FI|AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
180741|NCT01640951|O1|Outcome|AIN150FI|AIN457 150 mg - Fixed Interval (FI)
180742|NCT01640951|O9|Outcome|AIN300 OL|AIN457 300 mg Open-label (OL)
180743|NCT01640951|O8|Outcome|AIN300 SoR _ AIN300 FI|AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
180744|NCT01640951|O7|Outcome|AIN300 SoR|AIN457 300 mg - Start of Relapse (SoR)
180745|NCT01640951|O6|Outcome|AIN150 SOR_AIN300 FI|AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
180746|NCT01640951|O5|Outcome|AIN150 SoR|AIN457 150 mg - Start of Relapse (SoR)
180747|NCT01640951|O4|Outcome|AIN300 FI|AIN457 300 mg - Fixed Interval (FI)
180748|NCT01640951|O3|Outcome|AIN150FI (NSW+SW)|AIN457 150 mg - Fixed Interval combined non-switch and switch
188248|NCT01607203|B3|Baseline|Total|Total of all reporting groups
180749|NCT01640951|O2|Outcome|AIN150 FI_AIN300 FI|AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
180750|NCT01640951|O1|Outcome|AIN150FI|AIN457 150 mg - Fixed Interval (FI)
180751|NCT01640951|O9|Outcome|AIN300 OL|AIN457 300 mg Open-label (OL)
180752|NCT01640951|O8|Outcome|AIN300 SoR _ AIN300 FI|AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
180753|NCT01640951|O7|Outcome|AIN300 SoR|AIN457 300 mg - Start of Relapse (SoR)
180754|NCT01640951|O6|Outcome|AIN150 SOR_AIN300 FI|AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
180755|NCT01640951|O5|Outcome|AIN150 SoR|AIN457 150 mg - Start of Relapse (SoR)
180756|NCT01640951|O4|Outcome|AIN300 FI|AIN457 300 mg - Fixed Interval (FI)
180757|NCT01640951|O3|Outcome|AIN150FI (NSW+SW)|AIN457 150 mg - Fixed Interval combined non-switch and switch
180758|NCT01640951|O2|Outcome|AIN150 FI_AIN300 FI|AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
180759|NCT01640951|O1|Outcome|AIN150FI|AIN457 150 mg - Fixed Interval (FI)
180760|NCT01640951|O8|Outcome|AIN300 OL|AIN457 300 mg Open-label (OL)
180761|NCT01640951|O7|Outcome|AIN300 SoR _ AIN300 FI|AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
180762|NCT01640951|O6|Outcome|AIN300 SoR|AIN457 300 mg - Start of Relapse (SoR)
180763|NCT01640951|O5|Outcome|AIN150 SOR_AIN300 FI|AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
180764|NCT01640951|O4|Outcome|AIN150 SoR|AIN457 150 mg - Start of Relapse (SoR)
180765|NCT01640951|O3|Outcome|AIN300 FI|AIN457 300 mg - Fixed Interval (FI)
180766|NCT01640951|O2|Outcome|AIN150 FI_AIN300 FI|AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
180767|NCT01640951|O1|Outcome|AIN150FI|AIN457 150 mg - Fixed Interval (FI)
180768|NCT01640951|E3|Reported Event|Any AIN457 Dose|Any AIN457 dose
180769|NCT01640951|E2|Reported Event|Any AIN457 300 mg|Any AIN457 300 mg
180770|NCT01640951|E1|Reported Event|Any AIN457 150 mg|Any AIN457 150 mg
180771|NCT01640925|B3|Baseline|Total|Total of all reporting groups
180772|NCT01640925|B2|Baseline|Standard Bathing|"Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.~Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily."
180773|NCT01640925|B1|Baseline|Chlorhexidine Gluconate Bathing|"Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.~Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours"
180774|NCT01640925|P2|Participant Flow|Standard Bathing|"Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.~Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily."
180775|NCT01640925|P1|Participant Flow|Chlorhexidine Gluconate Bathing|"Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.~Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours"
180776|NCT01640925|O2|Outcome|Standard Bathing|"Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.~Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily."
180777|NCT01640925|O1|Outcome|Chlorhexidine Gluconate Bathing|"Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.~Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours"
180778|NCT01640925|O2|Outcome|Standard Bathing|"Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.~Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily."
180779|NCT01640925|O1|Outcome|Chlorhexidine Gluconate Bathing|"Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.~Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours"
180780|NCT01640925|O2|Outcome|Standard Bathing|"Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.~Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily."
180781|NCT01640925|O1|Outcome|Chlorhexidine Gluconate Bathing|"Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.~Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours"
180782|NCT01640925|O2|Outcome|Standard Bathing|"Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.~Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily."
180783|NCT01640925|O1|Outcome|Chlorhexidine Gluconate Bathing|"Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.~Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours"
180784|NCT01640925|E2|Reported Event|Standard Bathing|"Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.~Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily."
180818|NCT01640353|O1|Outcome|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
180819|NCT01640353|O1|Outcome|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
180785|NCT01640925|E1|Reported Event|Chlorhexidine Gluconate Bathing|"Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.~Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours"
180786|NCT01640548|B1|Baseline|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
180787|NCT01640548|P1|Participant Flow|Rheumatoid Arthritis (RA) Cohort|Participants on biologic disease modifying anti-rheumatic drug (bDMARD) monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
180788|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
180789|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
180790|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
180791|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
180792|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
180793|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
180794|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
180795|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
180796|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
180797|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
180798|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
180799|NCT01640548|E1|Reported Event|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
180800|NCT01640379|B3|Baseline|Total|Total of all reporting groups
180801|NCT01640379|B2|Baseline|Control|Participants receive enhanced standard of care
180802|NCT01640379|B1|Baseline|Intervention|Experimental: TECH-N Participants receive the Technology Enhanced Community Health Nursing Visit (community health nursing visits within 5 days during which Sister to Sister and clinical assessment performed and text-messaging support
180803|NCT01640379|P2|Participant Flow|Control|Participants receive enhanced standard of care
180804|NCT01640379|P1|Participant Flow|Intervention|Experimental: TECH-N Participants receive the Technology Enhanced Community Health Nursing Visit (community health nursing visits within 5 days during which Sister to Sister and clinical assessment performed and text-messaging support
180805|NCT01640379|O2|Outcome|Control|Participants receive enhanced standard of care
180806|NCT01640379|O1|Outcome|TECH-N|"Participants receive the Technology Enhanced Community Health Nursing Visit (community health nursing visits within 5 days during which Sister to Sister and clinical assessment performed and text-messaging support~Technology Enhanced Community Health Nursing: -Text-messaging (twice daily medication reminders w/ positive adherence messages, positive sexual health messages throughout the 30 day treatment period)~-Enhanced community health nursing visit on day 3-5, includes evidence-based STI/HIV prevention component (Sister to Sister Teen)"
180807|NCT01640379|O2|Outcome|Control|Participants receive enhanced standard of care
180808|NCT01640379|O1|Outcome|TECH-N|"Participants receive the Technology Enhanced Community Health Nursing Visit (community health nursing visits within 5 days during which Sister to Sister and clinical assessment performed and text-messaging support~Technology Enhanced Community Health Nursing: -Text-messaging (twice daily medication reminders w/ positive adherence messages, positive sexual health messages throughout the 30 day treatment period)~-Enhanced community health nursing visit on day 3-5, includes DEBI STI/HIV prevention component (Sister to Sister Teen)"
180809|NCT01640379|E2|Reported Event|Control|Participants receive enhanced standard of care
180810|NCT01640379|E1|Reported Event|Intervention|Experimental: TECH-N Participants receive the Technology Enhanced Community Health Nursing Visit (community health nursing visits within 5 days during which Sister to Sister and clinical assessment performed and text-messaging support
180811|NCT01640353|B1|Baseline|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
180812|NCT01640353|P1|Participant Flow|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
180813|NCT01640353|O1|Outcome|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
180814|NCT01640353|O1|Outcome|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
180815|NCT01640353|O1|Outcome|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
180816|NCT01640353|O1|Outcome|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
180817|NCT01640353|O1|Outcome|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
190511|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
180822|NCT01640340|B2|Baseline|Arm B|Ondansetron 24 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
180823|NCT01640340|B1|Baseline|Arm A|Palonosetron 0.25 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
180824|NCT01640340|P2|Participant Flow|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
180825|NCT01640340|P1|Participant Flow|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg day 1; aprepitant 125 mg day 1, 80 mg days 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
180826|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
180827|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
180828|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
180829|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
180830|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
180831|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
180832|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
180833|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
180834|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
180835|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
180836|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
180837|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
180838|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
180839|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
180840|NCT01640340|E2|Reported Event|Arm B|Ondansetron 24 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
180841|NCT01640340|E1|Reported Event|Arm A|Palonosetron 0.25 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
180842|NCT01640327|B3|Baseline|Total|Total of all reporting groups
180843|NCT01640327|B2|Baseline|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
180844|NCT01640327|B1|Baseline|18–60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
180845|NCT01640327|P2|Participant Flow|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
180846|NCT01640327|P1|Participant Flow|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
180847|NCT01640327|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
180848|NCT01640327|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
180849|NCT01640327|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
180850|NCT01640327|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
180851|NCT01640327|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
180852|NCT01640327|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
180853|NCT01640327|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
180854|NCT01640327|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
180855|NCT01640327|E2|Reported Event|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
180856|NCT01640327|E1|Reported Event|18–60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
180857|NCT01640314|B3|Baseline|Total|Total of all reporting groups
180858|NCT01640314|B2|Baseline|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
180859|NCT01640314|B1|Baseline|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
180860|NCT01640314|P2|Participant Flow|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
180861|NCT01640314|P1|Participant Flow|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
180862|NCT01640314|O2|Outcome|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
180863|NCT01640314|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
180864|NCT01640314|O2|Outcome|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
180865|NCT01640314|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
180866|NCT01640314|O2|Outcome|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
180867|NCT01640314|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
180868|NCT01640314|O2|Outcome|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
180869|NCT01640314|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
180870|NCT01640314|O2|Outcome|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
180871|NCT01640314|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
180872|NCT01640314|E2|Reported Event|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
180873|NCT01640314|E1|Reported Event|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
180874|NCT01640197|B3|Baseline|Total|Total of all reporting groups
180875|NCT01640197|B2|Baseline|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
180876|NCT01640197|B1|Baseline|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
180877|NCT01640197|P2|Participant Flow|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
180878|NCT01640197|P1|Participant Flow|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
180879|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
180880|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
180881|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
180882|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
180883|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
180884|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
180885|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
180886|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
180887|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
180888|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
180889|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
180890|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
180891|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
180892|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
180893|NCT01640197|E2|Reported Event|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
180894|NCT01640197|E1|Reported Event|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
180896|NCT01640184|B3|Baseline|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
180897|NCT01640184|B2|Baseline|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
180898|NCT01640184|B1|Baseline|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
180899|NCT01640184|P3|Participant Flow|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
180900|NCT01640184|P2|Participant Flow|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
180901|NCT01640184|P1|Participant Flow|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
180902|NCT01640184|O3|Outcome|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
180903|NCT01640184|O2|Outcome|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
180904|NCT01640184|O1|Outcome|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
180905|NCT01640184|O3|Outcome|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
180906|NCT01640184|O2|Outcome|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
180907|NCT01640184|O1|Outcome|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
180908|NCT01640184|O3|Outcome|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
180909|NCT01640184|O2|Outcome|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
180992|NCT01639703|P1|Participant Flow|CT Perfusion|Xenetix-CT perfusion imaging: Injection of 50 ml of Xenetix
180993|NCT01639703|O4|Outcome|CD31 >50%|Quantification of CD31 labelling greater than 50%
180994|NCT01639703|O3|Outcome|CD31 10-50%|Quantification of CD31 labelling from 10 to 50%
180995|NCT01639703|O2|Outcome|CD31 1-10%|Quantification of CD31 labelling from 1 to 10%
180910|NCT01640184|O1|Outcome|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
180911|NCT01640184|O3|Outcome|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
180912|NCT01640184|O2|Outcome|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
180913|NCT01640184|O1|Outcome|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
180914|NCT01640184|O2|Outcome|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
180915|NCT01640184|O1|Outcome|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
180916|NCT01640184|O3|Outcome|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
180917|NCT01640184|O2|Outcome|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
180918|NCT01640184|O1|Outcome|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: chronic kidney disease (CKD) patients suffered from secondary hyperparathyroidism (sHPT) with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
180919|NCT01640184|E3|Reported Event|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
180920|NCT01640184|E2|Reported Event|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
180921|NCT01640184|E1|Reported Event|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
180922|NCT01640171|B1|Baseline|Topical Anesthesia 1 Eye, SC 1 Eye|"Eye receiving only topical gel~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion~Fellow Eye:~Eye receiving topical gel and subconjunctival lidocaine~Xylocaine 2% Injectable Anesthetic: xylocaine 2% injection 0.1 cc~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion"
180923|NCT01640171|P1|Participant Flow|Topical Anesthesia 1 Eye, SC 1 Eye|"Eye receiving only topical gel~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion~Fellow eye Same as above plus Xylocaine 2% SC"
180924|NCT01640171|O1|Outcome|Topical Anesthesia 1 Eye, SC 1 Eye|"Eye receiving only topical gel~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment at three minute intervals~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion~Fellow eye:~Same as above plus SC Xylocaine was administered following the first two topical anesthetic applications"
180925|NCT01640171|O1|Outcome|Topical Anesthesia 1 Eye, SC 1 Eye|"Eye receiving only topical gel~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment at three minute intervals~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion~Fellow eye:~Same as above plus SC Xylocaine was administered following the first two topical anesthetic applications"
180926|NCT01640171|O1|Outcome|Topical Anesthesia 1 Eye, SC 1 Eye|"Eye receiving only topical gel~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment at three minute intervals~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion~Fellow eye:~Same as above plus SC Xylocaine was administered following the first two topical anesthetic applications"
180927|NCT01640171|E2|Reported Event|Subconjunctival Anesthesia|"Eye receiving topical gel and subconjunctival lidocaine~Xylocaine 2% Injectable Anesthetic: xylocaine 2% injection 0.1 cc~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion"
180928|NCT01640171|E1|Reported Event|Topical Anesthesia|"Eye receiving only topical gel~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion"
180929|NCT01640054|B1|Baseline|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
180930|NCT01640054|P1|Participant Flow|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
180931|NCT01640054|O1|Outcome|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
180932|NCT01640054|O1|Outcome|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
180933|NCT01640054|O1|Outcome|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
180934|NCT01640054|O1|Outcome|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
180935|NCT01640054|O1|Outcome|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
180936|NCT01640054|E1|Reported Event|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
180937|NCT01639833|B3|Baseline|Total|Total of all reporting groups
180938|NCT01639833|B2|Baseline|TachoSil®|"Topical Hemostat~TachoSil®: Topical Hemostat"
180939|NCT01639833|B1|Baseline|Veriset™ Hemostatic Patch|"Topical Hemostat~Veriset™ Hemostatic Patch: Topical hemostat"
180940|NCT01639833|P2|Participant Flow|TachoSil®|"Topical Hemostat~TachoSil®: Topical Hemostat"
180941|NCT01639833|P1|Participant Flow|Veriset™ Hemostatic Patch|"Topical Hemostat~Veriset™ Hemostatic Patch: Topical hemostat"
180942|NCT01639833|O2|Outcome|TachoSil®|"Topical Hemostat~TachoSil®: Topical Hemostat"
180943|NCT01639833|O1|Outcome|Veriset™ Hemostatic Patch|"Topical Hemostat~Veriset™ Hemostatic Patch: Topical hemostat"
180944|NCT01639833|O2|Outcome|TachoSil®|"Topical Hemostat~TachoSil®: Topical Hemostat"
180945|NCT01639833|O1|Outcome|Veriset™ Hemostatic Patch|"Topical Hemostat~Veriset™ Hemostatic Patch: Topical hemostat"
180946|NCT01639833|E2|Reported Event|TachoSil®|"Topical Hemostat~TachoSil®: Topical Hemostat"
180947|NCT01639833|E1|Reported Event|Veriset™ Hemostatic Patch|"Topical Hemostat~Veriset™ Hemostatic Patch: Topical hemostat"
180948|NCT01639755|B1|Baseline|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
180949|NCT01639755|P1|Participant Flow|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
180950|NCT01639755|O1|Outcome|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
180951|NCT01639755|O1|Outcome|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
180952|NCT01639755|O1|Outcome|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
180953|NCT01639755|O1|Outcome|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
180954|NCT01639755|O1|Outcome|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
180955|NCT01639755|E1|Reported Event|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
180956|NCT01639742|B1|Baseline|All Participants|All participants who had new texture round breast implants surgically implanted.
180957|NCT01639742|P1|Participant Flow|All Participants|All participants who had new texture round breast implants surgically implanted.
180958|NCT01639742|O1|Outcome|All Participants|All participants who had new texture round breast implants surgically implanted.
180959|NCT01639742|O1|Outcome|All Participants|All participants who had new texture round breast implants surgically implanted.
180960|NCT01639742|O1|Outcome|All Participants|All participants who had new texture round breast implants surgically implanted.
180961|NCT01639742|O1|Outcome|All Participants|All participants who had new texture round breast implants surgically implanted.
180962|NCT01639742|O1|Outcome|All Participants|All participants who had new texture round breast implants surgically implanted.
180963|NCT01639742|E1|Reported Event|All Participants|All participants who had new texture round breast implants surgically implanted.
180996|NCT01639703|O1|Outcome|CD31 0%|Absence of CD31 labelling
180997|NCT01639703|O4|Outcome|Glutamine Synthetase >50%|Quantification of glutamine synthetase labelling greater than 50%
180998|NCT01639703|O3|Outcome|Glutamine Synthetase 10-50%|Quantification of glutamine synthetase labelling from 10 to 50%
180999|NCT01639703|O2|Outcome|Glutamine Synthetase 1-10%|Quantification of glutamine synthetase labelling from 1 to 10%
180964|NCT01639729|B1|Baseline|Treatment A, Followed by Treatment B, C and D in Random Order|Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV) Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL) Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU) Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO) Sequence 1: A, B, C, D Sequence 2: A, B, D, C Sequence 3: A, C, B, D Sequence 4: A, C, D, B Sequence 5: A, D, B, C Sequence 6: A, D, C, B A 48-hour washout period separated each treatment period. The washout began with the start of dosing.
180965|NCT01639729|P6|Participant Flow|Sequence 6: Treatments A, D, C, B|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)~Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)~Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)~Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)~A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
180966|NCT01639729|P5|Participant Flow|Sequence Five: Treatments A, D, B, C|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)~Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)~Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)~Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)~A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
180967|NCT01639729|P4|Participant Flow|Sequence 4: Treatment A, C, D, B|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)~Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)~Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)~Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)~A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
180968|NCT01639729|P3|Participant Flow|Sequence 3: Treatment A, C, B, D|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)~Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)~Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)~Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)~A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
180969|NCT01639729|P2|Participant Flow|Sequence 2: A, B, D, C|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)~Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)~Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)~Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)~A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
180970|NCT01639729|P1|Participant Flow|Sequence 1: Treatment A, B, C, D|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)~Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)~Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)~Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)~A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
180971|NCT01639729|O4|Outcome|Sufentanil NanoTab Oral|"Sufentanil : 15 mcg oral~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
180972|NCT01639729|O3|Outcome|Sufentanil NanoTab Sublingual|"Sufentanil : 15 mcg sublingual~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
180973|NCT01639729|O2|Outcome|Sufentanil NanoTab Buccal|"Sufentanil : 15 mcg buccal~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
180974|NCT01639729|O1|Outcome|Sufentanil IV|"Sufentanil : 15 mcg IV~PK sampling 0 (predose), 1, 4, 7, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
180975|NCT01639729|O4|Outcome|Sufentanil NanoTab Oral|"Sufentanil : 15 mcg oral~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
180976|NCT01639729|O3|Outcome|Sufentanil NanoTab Sublingual|"Sufentanil : 15 mcg sublingual~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
180977|NCT01639729|O2|Outcome|Sufentanil NanoTab Buccal|"Sufentanil : 15 mcg buccal~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
180978|NCT01639729|O1|Outcome|Sufentanil IV|"Sufentanil : 15 mcg IV~PK sampling 0 (predose), 1, 4, 7, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
180979|NCT01639729|O4|Outcome|Sufentanil NanoTab Oral|"Sufentanil : 15 mcg oral~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
180980|NCT01639729|O3|Outcome|Sufentanil NanoTab Sublingual|"Sufentanil : 15 mcg sublingual~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
180981|NCT01639729|O2|Outcome|Sufentanil NanoTab Buccal|"Sufentanil : 15 mcg buccal~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
180982|NCT01639729|O1|Outcome|Sufentanil IV|"Sufentanil : 15 mcg IV~PK sampling 0 (predose), 1, 4, 7, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
180983|NCT01639729|O4|Outcome|Sufentanil NanoTab Oral|"Sufentanil : 15 mcg oral~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
180984|NCT01639729|O3|Outcome|Sufentanil NanoTab Sublingual|"Sufentanil : 15 mcg sublingual~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
180985|NCT01639729|O2|Outcome|Sufentanil NanoTab Buccal|"Sufentanil : 15 mcg buccal~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
180986|NCT01639729|O1|Outcome|Sufentanil IV|"Sufentanil : 15 mcg IV~PK sampling 0 (predose), 1, 4, 7, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
180987|NCT01639729|E4|Reported Event|Sufentanil NanoTab Oral|Sufentanil : 15 mcg oral
180988|NCT01639729|E3|Reported Event|Sufentanil NanoTab Sublingual|Sufentanil : 15 mcg sublingaul
180989|NCT01639729|E2|Reported Event|Sufentanil NanoTab Buccal|Sufentanil : 15 mcg buccal
180990|NCT01639729|E1|Reported Event|Sufentanil IV|Sufentanil : 15 mcg IV
180991|NCT01639703|B1|Baseline|All Included Patients|All patients included in the study.
181005|NCT01639703|O4|Outcome|Glutamine Synthetase >50%|Quantification of glutamine synthetase labelling greater than 50%
181006|NCT01639703|O3|Outcome|Glutamine Synthetase 10-50%|Quantification of glutamine synthetase labelling from 10 to 50%
181007|NCT01639703|O2|Outcome|Glutamine Synthetase 1-10%|Quantification of glutamine synthetase labelling from 1 to 10%
181008|NCT01639703|O1|Outcome|Glutamine Synthetase 0%|Absence of glutamine synthetase labelling
181009|NCT01639703|O4|Outcome|CD31 >50%|Quantification of CD31 labelling greater than 50%
181010|NCT01639703|O3|Outcome|CD31 10-50%|Quantification of CD31 labelling from 10 to 50%
181011|NCT01639703|O2|Outcome|CD31 1-10%|Quantification of CD31 labelling from 1 to 10%
181012|NCT01639703|O1|Outcome|CD31 0%|Absence of CD31 labelling
181013|NCT01639703|O4|Outcome|Glutamine Synthetase >50%|Quantification of glutamine synthetase labelling greater than 50%
181014|NCT01639703|O3|Outcome|Glutamine Synthetase 10-50%|Quantification of glutamine synthetase labelling from 10 to 50%
181015|NCT01639703|O2|Outcome|Glutamine Synthetase 1-10%|Quantification of glutamine synthetase labelling from 1 to 10%
181016|NCT01639703|O1|Outcome|Glutamine Synthetase 0%|Absence of glutamine synthetase labelling
181017|NCT01639703|O2|Outcome|Moderately/Poorly Differentiated Lesions|Among the 90 lesions analyzed, 43 were moderately or poorly differentiated according to WHO classification.
181018|NCT01639703|O1|Outcome|Well Differentiated Lesions|Among the 90 lesions analyzed, 47 were well differentiated according to WHO classification.
181019|NCT01639703|O2|Outcome|Moderately/Poorly Differentiated Lesions|Among the 90 lesions analyzed, 43 were moderately or poorly differentiated according to WHO classification.
181020|NCT01639703|O1|Outcome|Well Differentiated Lesions|Among the 90 lesions analyzed, 47 were well differentiated according to WHO classification.
181021|NCT01639703|O2|Outcome|Moderately/Poorly Differentiated Lesions|Among the 90 lesions analyzed, 43 were moderately or poorly differentiated according to WHO classification.
181022|NCT01639703|O1|Outcome|Well Differentiated Lesions|Among the 90 lesions analyzed, 47 were well differentiated according to WHO classification.
181023|NCT01639703|O2|Outcome|Moderately/Poorly Differentiated Lesions|Among the 90 lesions analyzed, 43 were moderately or poorly differentiated according to WHO classification.
181024|NCT01639703|O1|Outcome|Well Differentiated Lesions|Among the 90 lesions analyzed, 47 were well differentiated according to WHO classification
181025|NCT01639703|O2|Outcome|Moderately/Poorly Differentiated Lesions|Among the 90 lesions analyzed, 43 were moderately or poorly differentiated according to WHO classification.
181026|NCT01639703|O1|Outcome|Well Differentiated Lesions|Among the 90 lesions analyzed, 47 were well differentiated according to WHO classification.
181027|NCT01639703|O2|Outcome|Moderately/Poorly Differentiated Lesions|Among the 90 lesions analyzed, 43 were moderately or poorly differentiated according to WHO classification.
181028|NCT01639703|O1|Outcome|Well Differentiated Lesions|Among the 90 lesions analyzed, 47 were well differentiated according to WHO classification.
181029|NCT01639703|O2|Outcome|Moderately/Poorly Differentiated Lesions|Among the 90 lesions analyzed, 43 were moderately or poorly differentiated according to WHO classification.
181030|NCT01639703|O1|Outcome|Well Differentiated Lesions|Among the 90 lesions analyzed for CT perfusion parameters, 47 were well differentiated according to WHO classification.
181031|NCT01639703|E1|Reported Event|Safety Set|All included patients receiving at least one injection of Xenetix, regardless of the quantity. This set was used for safety analyses.
181032|NCT01639560|B3|Baseline|Total|Total of all reporting groups
181033|NCT01639560|B2|Baseline|Placebo|"1 placebo tablet twice a day for 12 weeks~Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
181034|NCT01639560|B1|Baseline|Varenicline|"1 mg of varenicline twice per day for 12 weeks.~Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
181035|NCT01639560|P2|Participant Flow|Placebo|"1 placebo tablet twice a day for 12 weeks~Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
181036|NCT01639560|P1|Participant Flow|Varenicline|"1 mg of varenicline twice per day for 12 weeks.~Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
181037|NCT01639560|O2|Outcome|Placebo|"1 placebo tablet twice a day for 12 weeks~Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
181038|NCT01639560|O1|Outcome|Varenicline|"1 mg of varenicline twice per day for 12 weeks.~Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
181039|NCT01639560|O2|Outcome|Placebo|"1 placebo tablet twice a day for 12 weeks~Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
181040|NCT01639560|O1|Outcome|Varenicline|"1 mg of varenicline twice per day for 12 weeks.~Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
181041|NCT01639560|O2|Outcome|Placebo|"1 placebo tablet twice a day for 12 weeks~Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
181042|NCT01639560|O1|Outcome|Varenicline|"1 mg of varenicline twice per day for 12 weeks.~Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
181043|NCT01639560|O2|Outcome|Placebo|"1 placebo tablet twice a day for 12 weeks~Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
181044|NCT01639560|O1|Outcome|Varenicline|"1 mg of varenicline twice per day for 12 weeks.~Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
181045|NCT01639560|E2|Reported Event|Placebo|"1 placebo tablet twice a day for 12 weeks~Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
181046|NCT01639560|E1|Reported Event|Varenicline|"1 mg of varenicline twice per day for 12 weeks.~Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
181047|NCT01639495|B1|Baseline|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation
181048|NCT01639495|P1|Participant Flow|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation
181049|NCT01639495|O1|Outcome|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation
181081|NCT01639443|E2|Reported Event|Control|Patients who are scheduled routinely
181050|NCT01639495|O1|Outcome|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation
181051|NCT01639495|O1|Outcome|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation
181052|NCT01639495|O1|Outcome|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation
181053|NCT01639495|O1|Outcome|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation
181054|NCT01639495|E1|Reported Event|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation
181055|NCT01639469|B3|Baseline|Total|Total of all reporting groups
181056|NCT01639469|B2|Baseline|Lifestyle Exercise|"Lifestyle exercise program taught via smartphone~Lifestyle exercise: Subjects will be taught lifestyle exercises and advised about mobility strategies"
181057|NCT01639469|B1|Baseline|Structured Exercise|"Structured exercise instruction by smartphone~Structured exercise: Structured exercise includes stretching, strengthening, and balance exercises."
181058|NCT01639469|P2|Participant Flow|Lifestyle Exercise|"Lifestyle exercise program taught via smartphone~Lifestyle exercise: Subjects will be taught lifestyle exercises and advised about mobility strategies"
181059|NCT01639469|P1|Participant Flow|Structured Exercise|"Structured exercise instruction by smartphone~Structured exercise: Structured exercise includes stretching, strengthening, and balance exercises."
181060|NCT01639469|O2|Outcome|Lifestyle Exercise|"Lifestyle exercise program taught via smartphone~Lifestyle exercise: Subjects will be taught lifestyle exercises and advised about mobility strategies"
181061|NCT01639469|O1|Outcome|Structured Exercise|"Structured exercise instruction by smartphone~Structured exercise: Structured exercise includes stretching, strengthening, and balance exercises."
181062|NCT01639469|E2|Reported Event|Lifestyle Exercise|"Lifestyle exercise program taught via smartphone~Lifestyle exercise: Subjects will be taught lifestyle exercises and advised about mobility strategies"
181063|NCT01639469|E1|Reported Event|Structured Exercise|"Structured exercise instruction by smartphone~Structured exercise: Structured exercise includes stretching, strengthening, and balance exercises."
181064|NCT01639443|B3|Baseline|Total|Total of all reporting groups
181065|NCT01639443|B2|Baseline|Control|Patients who are scheduled routinely
181066|NCT01639443|B1|Baseline|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
181067|NCT01639443|P2|Participant Flow|Control|Patients who are scheduled routinely
181068|NCT01639443|P1|Participant Flow|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
181069|NCT01639443|O2|Outcome|Control|Patients who are scheduled routinely
181070|NCT01639443|O1|Outcome|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
181071|NCT01639443|O2|Outcome|Control|Patients who are scheduled routinely
181072|NCT01639443|O1|Outcome|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
181073|NCT01639443|O2|Outcome|Control|Patients who are scheduled routinely
181074|NCT01639443|O1|Outcome|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
181075|NCT01639443|O2|Outcome|Control|Patients who are scheduled routinely
181076|NCT01639443|O1|Outcome|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
181077|NCT01639443|O2|Outcome|Control|Patients who are scheduled routinely
181078|NCT01639443|O1|Outcome|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
181079|NCT01639443|O2|Outcome|Control|Patients who are scheduled routinely
181080|NCT01639443|O1|Outcome|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
181082|NCT01639443|E1|Reported Event|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
181083|NCT01639352|B1|Baseline|SOM230|"60mg of SOM230 via injection intramuscularly every 28 days~SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days."
181084|NCT01639352|P1|Participant Flow|SOM230|"60mg of SOM230 via injection intramuscularly every 28 days~SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days."
181085|NCT01639352|O1|Outcome|SOM230|"60mg of SOM230 via injection intramuscularly every 28 days~SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days."
181086|NCT01639352|O1|Outcome|SOM230|"60mg of SOM230 via injection intramuscularly every 28 days~SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days."
181087|NCT01639352|O1|Outcome|SOM230|"60mg of SOM230 via injection intramuscularly every 28 days~SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days."
181088|NCT01639352|O1|Outcome|SOM230|"60mg of SOM230 via injection intramuscularly every 28 days~SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days."
181089|NCT01639352|O1|Outcome|SOM230|"60mg of SOM230 via injection intramuscularly every 28 days~SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days."
181090|NCT01639352|O1|Outcome|SOM230|"60mg of SOM230 via injection intramuscularly every 28 days~SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days."
181091|NCT01639352|E1|Reported Event|SOM230|"60mg of SOM230 via injection intramuscularly every 28 days~SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days."
181092|NCT01639222|B1|Baseline|Calcium 500 mg and Vitamin D3 800 IU|"Period 1: Low calcium meals for up to 3 days.~Period 2: Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily for up to 3 days with low calcium meals."
181093|NCT01639222|P1|Participant Flow|Calcium 500 mg and Vitamin D3 800 IU|"Period 1: Low calcium meals for up to 3 days.~Period 2: Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily for up to 3 days with low calcium meals."
181094|NCT01639222|O2|Outcome|Reference Treatment|Period 1 (Days 1-3): 200 mL of non-carbonated water (mock treatment) with low calcium meals for up to 3 days.
181095|NCT01639222|O1|Outcome|Calcium 500 mg and Vitamin D3 800 IU|Period 2 (Days 4-6): Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily, followed by 200 mL of non-carbonated water, for up to 3 days with low calcium meals.
181096|NCT01639222|O2|Outcome|Reference Treatment|Period 1 (Days 1-3): 200 mL of non-carbonated water (mock treatment) with low calcium meals for up to 3 days.
181097|NCT01639222|O1|Outcome|Calcium 500 mg and Vitamin D3 800 IU|Period 2 (Days 4-6): Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily, followed by 200 mL of non-carbonated water, for up to 3 days with low calcium meals.
181098|NCT01639222|O2|Outcome|Reference Treatment|Period 1 (Days 1-3): 200 mL of non-carbonated water (mock treatment) with low calcium meals for up to 3 days.
181099|NCT01639222|O1|Outcome|Calcium 500 mg and Vitamin D3 800 IU|Period 2 (Days 4-6): Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily, followed by 200 mL of non-carbonated water, for up to 3 days with low calcium meals.
181100|NCT01639222|E2|Reported Event|Reference Treatment|Period 1 (Days 1-3): 200 mL of non-carbonated water (mock treatment) with low calcium meals for up to 3 days.
181101|NCT01639222|E1|Reported Event|Calcium 500 mg and Vitamin D3 800 IU|Period 2 (Days 4-6): Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily, followed by 200 mL of non-carbonated water, for up to 3 days with low calcium meals.
181102|NCT01639157|B1|Baseline|All Study Participants|Subjects were maintained on oral buspirone (10 mg administered 3 times daily) or placebo for 6 days each during the study in random order.
181103|NCT01639157|P2|Participant Flow|Placebo Then Buspirone|Subjects were maintained on placebo daily for 6 days, then they were crossed over to 30 mg buspirone daily for 6 days.
181104|NCT01639157|P1|Participant Flow|Buspirone Then Placebo|Subjects were maintained on 30 mg buspirone daily for 6 days, then they were crossed over to placebo daily for 6 days.
181105|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181106|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181107|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181108|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181109|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181110|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181111|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181112|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181113|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181114|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181115|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181116|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181117|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181118|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181119|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181120|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181121|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181122|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181123|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181124|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181125|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181126|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181127|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181128|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181129|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181130|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181131|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181132|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181133|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181134|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181135|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181136|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181137|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181138|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181139|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181140|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181141|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181142|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181143|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181144|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181145|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181146|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181147|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181148|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181149|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181150|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181151|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181152|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181153|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181154|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181155|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181156|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181157|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
181158|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
181159|NCT01639157|E2|Reported Event|Placebo|"Subjects will be maintained on placebo.~Buspirone: Subjects will be maintained on oral buspirone (administered 3 times daily) or placebo for 6 days each during the study in random order.These subjects will be the same as those who are maintained on buspirone (i.e., the study uses a within-subjects design)."
181160|NCT01639157|E1|Reported Event|Buspirone|"Subjects will be maintained on buspirone.~Buspirone: Subjects will be maintained on oral buspirone (administered 3 times daily) or placebo for 6 days each during the study in random order. These subjects will be the same as those who are maintained on placebo (i.e., the study uses a within-subjects design)."
181161|NCT01639144|B3|Baseline|Total|Total of all reporting groups
181162|NCT01639144|B2|Baseline|Control|Group not receiving autogenous PRP and PPP.
181163|NCT01639144|B1|Baseline|Receiving PRP and PPP.|"Administration of PRP and PPP to surgical site.~PRP and PPP: Autogenous PRP and PPP"
181164|NCT01639144|P2|Participant Flow|Control|Group not receiving autogenous PRP and PPP.
181165|NCT01639144|P1|Participant Flow|Receiving PRP and PPP.|Administration of PRP and PPP to surgical site.
181166|NCT01639144|O2|Outcome|Control|Group not receiving autogenous PRP and PPP.
181167|NCT01639144|O1|Outcome|Receiving PRP and PPP.|Administration of PRP and PPP to surgical site.
181168|NCT01639144|E2|Reported Event|Control|Group not receiving autogenous PRP and PPP.
181169|NCT01639144|E1|Reported Event|Receiving PRP and PPP.|Administration of PRP and PPP to surgical site.
181170|NCT01639040|B3|Baseline|Total|Total of all reporting groups
181171|NCT01639040|B2|Baseline|REGN668 300 mg|REGN668 300 mg once weekly for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days
181172|NCT01639040|B1|Baseline|Placebo|Placebo (for REGN668) once weekly for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days.
181173|NCT01639040|P2|Participant Flow|Dupilumab 300 mg QW|Dupilumab 300 mg once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days
181174|NCT01639040|P1|Participant Flow|Placebo QW|Placebo (for Dupilumab) once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent topical corticosteroid (TCS) for up to 28 days.
181175|NCT01639040|O2|Outcome|REGN668 300 mg|REGN668 300 mg once weekly for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days.
181176|NCT01639040|O1|Outcome|Placebo|Placebo (for REGN668) once weekly for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days.
181177|NCT01639040|O2|Outcome|REGN668 300 mg|REGN668 300 mg once weekly for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days.
190593|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
181178|NCT01639040|O1|Outcome|Placebo|Placebo (for REGN668) once weekly for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days
181179|NCT01639040|O2|Outcome|REGN668 300 mg|REGN668 300 mg once weekly for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days.
181180|NCT01639040|O1|Outcome|Placebo|Placebo (for REGN668) once weekly for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days
181181|NCT01639040|O2|Outcome|REGN668 300 mg|REGN668 300 mg once weekly for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days.
181182|NCT01639040|O1|Outcome|Placebo|Placebo (for REGN668) once weekly for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days.
181183|NCT01639040|O2|Outcome|Dupilumab 300 mg QW|Dupilumab 300 mg once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days
181184|NCT01639040|O1|Outcome|Placebo QW|Placebo (for Dupilumab) once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent topical corticosteroid (TCS) for up to 28 days
181185|NCT01639040|O2|Outcome|Dupilumab 300 mg QW|Dupilumab 300 mg once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days
181186|NCT01639040|O1|Outcome|Placebo QW|Placebo (for Dupilumab) once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent topical corticosteroid (TCS) for up to 28 days
181187|NCT01639040|E2|Reported Event|REGN668 300 mg|REGN668 300 mg once weekly for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days.
181188|NCT01639040|E1|Reported Event|Placebo|Placebo (for REGN668) once weekly for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days
181189|NCT01639001|B3|Baseline|Total|Total of all reporting groups
181190|NCT01639001|B2|Baseline|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
181191|NCT01639001|B1|Baseline|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
181192|NCT01639001|P2|Participant Flow|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
181193|NCT01639001|P1|Participant Flow|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
181194|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
181195|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
181196|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
181197|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
181198|NCT01639001|O2|Outcome|Participants With Negative ALK FISH Status|Participants in the Molecular Profiling Evaluable population that had negative ALK FISH results.
181199|NCT01639001|O1|Outcome|Participants With Positive ALK FISH Status|Participants in the Molecular Profiling Evaluable population that had positive ALK FISH results.
181241|NCT01638546|B2|Baseline|Arm II (Placebo and Temozolomide)|"Patients receive placebo PO BID on days 1-7 and temozolomide as in Arm I.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Temozolomide: Given PO"
181320|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181200|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
181201|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
181202|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
181203|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
181204|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
181205|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
181206|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
181207|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
181208|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
181209|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
181210|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
181211|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
181212|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
181321|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181213|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
181214|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
181215|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
181216|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
181217|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
181218|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
181219|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
181220|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
181221|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
181222|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
181223|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
181224|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
181225|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
181242|NCT01638546|B1|Baseline|Arm I (Veliparib and Temozolomide)|"Patients receive veliparib PO BID on days 1-7 and temozolomide PO on days 1-5.~Laboratory Biomarker Analysis: Correlative studies~Temozolomide: Given PO~Veliparib: Given PO"
181226|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
181227|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
181228|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
181229|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
181230|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
181231|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
181232|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
181233|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
181234|NCT01639001|E2|Reported Event|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
181235|NCT01639001|E1|Reported Event|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
181236|NCT01638559|B1|Baseline|Participants That Initiated Withdrawal|Pediatric liver transplant recipients with stable liver function tests, no evidence of rejection in the past 2 years, and at least 4 years post-transplant underwent gradual Immunosuppression withdrawal in no less than 36 weeks and no more than 52 weeks with frequent monitoring of liver tests. All participants were followed for 48 months ensuring a minimum of 36 months of follow-up after successful Immunosuppression withdrawal.
181237|NCT01638559|P1|Participant Flow|Participants That Initiated Withdrawal|Pediatric liver transplant recipients with stable liver function tests, no evidence of rejection in the past 2 years, and at least 4 years post-transplant underwent gradual Immunosuppression withdrawal in no less than 36 weeks and no more than 52 weeks with frequent monitoring of liver tests. All participants were followed for 48 months ensuring a minimum of 36 months of follow-up after successful Immunosuppression withdrawal.
181238|NCT01638559|O1|Outcome|Participants That Initiated Withdrawal|Pediatric liver transplant recipients with stable liver function tests, no evidence of rejection in the past 2 years, and at least 4 years post-transplant underwent gradual Immunosuppression withdrawal in no less than 36 weeks and no more than 52 weeks with frequent monitoring of liver tests. All participants were followed for 48 months ensuring a minimum of 36 months of follow-up after successful Immunosuppression withdrawal.
181239|NCT01638559|E1|Reported Event|All Screened Participants|All participants that were screened for the study.
181240|NCT01638546|B3|Baseline|Total|Total of all reporting groups
181318|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181243|NCT01638546|P2|Participant Flow|Arm II (Placebo and Temozolomide)|"Patients receive placebo PO BID on days 1-7 and temozolomide as in Arm I.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Temozolomide: Given PO"
181244|NCT01638546|P1|Participant Flow|Arm I (Veliparib and Temozolomide)|"Patients receive veliparib PO BID on days 1-7 and temozolomide PO on days 1-5.~Laboratory Biomarker Analysis: Correlative studies~Temozolomide: Given PO~Veliparib: Given PO"
181245|NCT01638546|O2|Outcome|Arm II (Placebo and Temozolomide)|"Patients receive placebo PO BID on days 1-7 and temozolomide as in Arm I.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Temozolomide: Given PO"
181246|NCT01638546|O1|Outcome|Arm I (Veliparib and Temozolomide)|"Patients receive veliparib PO BID on days 1-7 and temozolomide PO on days 1-5.~Laboratory Biomarker Analysis: Correlative studies~Temozolomide: Given PO~Veliparib: Given PO"
181247|NCT01638546|O2|Outcome|Arm II (Placebo and Temozolomide)|"Patients receive placebo PO BID on days 1-7 and temozolomide as in Arm I.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Temozolomide: Given PO"
181248|NCT01638546|O1|Outcome|Arm I (Veliparib and Temozolomide)|"Patients receive veliparib PO BID on days 1-7 and temozolomide PO on days 1-5.~Laboratory Biomarker Analysis: Correlative studies~Temozolomide: Given PO~Veliparib: Given PO"
181249|NCT01638546|E2|Reported Event|Arm II (Placebo and Temozolomide)|"Patients receive placebo PO BID on days 1-7 and temozolomide as in Arm I.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Temozolomide: Given PO"
181250|NCT01638546|E1|Reported Event|Arm I (Veliparib and Temozolomide)|"Patients receive veliparib PO BID on days 1-7 and temozolomide PO on days 1-5.~Laboratory Biomarker Analysis: Correlative studies~Temozolomide: Given PO~Veliparib: Given PO"
181251|NCT01638507|B1|Baseline|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
181252|NCT01638507|P1|Participant Flow|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
181253|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
181254|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
181255|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
181256|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
181257|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
181258|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
181259|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
181260|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
181261|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
181262|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents of less than or equal to 30 mm in length.
181263|NCT01638507|E1|Reported Event|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
181264|NCT01638468|B1|Baseline|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
181265|NCT01638468|P1|Participant Flow|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
181266|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
181267|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
181268|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
181269|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
181270|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
181319|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181271|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
181272|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
181273|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
181274|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
181275|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
181276|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
181277|NCT01638468|E1|Reported Event|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
181278|NCT01638312|B3|Baseline|Total|Total of all reporting groups
181279|NCT01638312|B2|Baseline|"Healthy Controls"|The people didn't have infected HIV
181280|NCT01638312|B1|Baseline|"HIV Infected Patients"|The people had infected HIV
181281|NCT01638312|P2|Participant Flow|"Healthy Controls"|The people didn't have infected HIV
181282|NCT01638312|P1|Participant Flow|"HIV Infected Patients"|The people had infected HIV
181283|NCT01638312|O2|Outcome|"Healthy Controls"|"Healthy people~Graphical analysis of healthy people 1.7 of 30 healthy people were positive in waveform, and 23 were negative, the negative predictive value was 76.67%.~2.Healthy people was subjective judgments of participants, no other test as proof.~3.Graphical analysis of HIV-infected subjects"
181284|NCT01638312|O1|Outcome|"HIV Infected Patients"|20 There are six medication negative response, referring to a recent comparison of the value of the blood virus date, there are three items detected waveform error, the remaining non-medication of 14, there are two detection waveform is negative; positive predictive value = 60%
181285|NCT01638312|E2|Reported Event|"Healthy Controls"|Serious and Other (Not Including Serious) Adverse Events were not collected
181286|NCT01638312|E1|Reported Event|"HIV Infected Patients"|Serious and Other (Not Including Serious) Adverse Events were not collected
181287|NCT01638000|B3|Baseline|Total|Total of all reporting groups
181288|NCT01638000|B2|Baseline|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181289|NCT01638000|B1|Baseline|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181290|NCT01638000|P2|Participant Flow|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181291|NCT01638000|P1|Participant Flow|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181292|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181293|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181294|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181295|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181296|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181297|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181298|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181299|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181300|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181301|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181302|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181303|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181304|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181305|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181306|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181307|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181308|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181309|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181310|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181311|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181312|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181313|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181314|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181315|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181316|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181317|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181322|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181323|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181324|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181325|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181326|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181327|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181328|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181329|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181330|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181331|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181332|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181333|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181334|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181335|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181336|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181337|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181338|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181339|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181340|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181341|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181342|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181343|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181344|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181345|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181346|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181347|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181348|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181349|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181350|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181351|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181352|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181353|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181354|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181355|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181356|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181357|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181358|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181359|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181360|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181361|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181362|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181363|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181364|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181365|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181366|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181367|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181368|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181369|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181370|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181371|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181372|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181373|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181374|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181375|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181376|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181377|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181378|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181379|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181380|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181381|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181382|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181383|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181384|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181385|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181386|NCT01638000|E2|Reported Event|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
181387|NCT01638000|E1|Reported Event|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
181388|NCT01637961|B1|Baseline|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
181389|NCT01637961|P1|Participant Flow|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
181390|NCT01637961|O1|Outcome|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
181391|NCT01637961|O6|Outcome|Grade 5 (CTCAE v 4.0)|Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
181392|NCT01637961|O5|Outcome|Grade 4 (CTCAE v 4.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
181393|NCT01637961|O4|Outcome|Grade 3 (CTCAE v 4.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
181394|NCT01637961|O3|Outcome|Grade 2 (CTCAE v 4.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
181395|NCT01637961|O2|Outcome|Grade 1 (CTCAE v 4.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
181396|NCT01637961|O1|Outcome|Grade 0|Number of patients who did not experience the specified AE.
181397|NCT01637961|O1|Outcome|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
181398|NCT01637961|O1|Outcome|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
181399|NCT01637961|O1|Outcome|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
181400|NCT01637961|E1|Reported Event|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
181401|NCT01637935|B3|Baseline|Total|Total of all reporting groups
181402|NCT01637935|B2|Baseline|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
181403|NCT01637935|B1|Baseline|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
181404|NCT01637935|P2|Participant Flow|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
181405|NCT01637935|P1|Participant Flow|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
181406|NCT01637935|O2|Outcome|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
181407|NCT01637935|O1|Outcome|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
181408|NCT01637935|O2|Outcome|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
181409|NCT01637935|O1|Outcome|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
181410|NCT01637935|O2|Outcome|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
181411|NCT01637935|O1|Outcome|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
181412|NCT01637935|O2|Outcome|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
181413|NCT01637935|O1|Outcome|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
181414|NCT01637935|O2|Outcome|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
181415|NCT01637935|O1|Outcome|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
181416|NCT01637935|E2|Reported Event|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
181417|NCT01637935|E1|Reported Event|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
181418|NCT01637922|B3|Baseline|Total|Total of all reporting groups
181419|NCT01637922|B2|Baseline|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
181420|NCT01637922|B1|Baseline|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
181421|NCT01637922|P2|Participant Flow|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): Oral dose of BI 201335(faldaprevir) 480 mg on day 2 and 240 mg twice daily for days 3 to 9."
181422|NCT01637922|P1|Participant Flow|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): Oral dose of BI 201335(faldaprevir) 480 mg on day 2 and 240 mg twice daily for days 3 to 9."
181423|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
181424|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
181425|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
181426|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
181427|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
181428|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
181429|NCT01637922|O2|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
181430|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
181431|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
181432|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
181433|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
181434|NCT01637922|O2|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
181435|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
181436|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
181437|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
181438|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
181439|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
181440|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
181441|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
181442|NCT01637922|E2|Reported Event|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
181443|NCT01637922|E1|Reported Event|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
181444|NCT01637870|B1|Baseline|Negative Pressure Pump|Will have the Prevena negative pressure wound system placed at the time of surgery.
181445|NCT01637870|P1|Participant Flow|Negative Pressure Pump|Will have the Prevena negative pressure wound system placed at the time of surgery.
181446|NCT01637870|O1|Outcome|Negative Pressure Pump|Will have the Prevena negative pressure wound system placed at the time of surgery.
181447|NCT01637870|E1|Reported Event|Negative Pressure Pump|"Will have the Prevena negative pressure wound system placed at the time of surgery.~Prevena negative pressure wound system: Placement of negative pressure wound system at the time of cesarean delivery for those at increased risk for wound complication"
181448|NCT01637584|B3|Baseline|Total|Total of all reporting groups
181449|NCT01637584|B2|Baseline|Placebo|"A placebo is a sugar pill, which will be used to compare with the results of the active medication~Placebo: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
181450|NCT01637584|B1|Baseline|Prazosin|"Active medication arm. Prazosin is an FDA approved medication, originally designed as an anti-hypertension medication. Side effects of the medication in some include sleepiness and once asleep, sustained sleep.~Prazosin: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
181451|NCT01637584|P2|Participant Flow|Placebo|"A placebo is a sugar pill, which will be used to compare with the results of the active medication~Placebo: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
181452|NCT01637584|P1|Participant Flow|Prazosin|"Active medication arm. Prazosin is an FDA approved medication, originally designed as an anti-hypertension medication. Side effects of the medication in some include sleepiness and once asleep, sustained sleep.~Prazosin: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
181453|NCT01637584|O2|Outcome|Placebo|"A placebo is a sugar pill, which will be used to compare with the results of the active medication~Placebo: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
181454|NCT01637584|O1|Outcome|Prazosin|"Active medication arm. Prazosin is an FDA approved medication, originally designed as an anti-hypertension medication. Side effects of the medication in some include sleepiness and once asleep, sustained sleep.~Prazosin: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
181455|NCT01637584|O1|Outcome|Prazosin -Placebo|Difference in relative brain glucose metabolism between states and pre-to-post treatment for participants randomized to prazosin after adjusting for non-significant changes in the placebo group.
181456|NCT01637584|E2|Reported Event|Placebo|"A placebo is a sugar pill, which will be used to compare with the results of the active medication~Placebo: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
181457|NCT01637584|E1|Reported Event|Prazosin|"Active medication arm. Prazosin is an FDA approved medication, originally designed as an anti-hypertension medication. Side effects of the medication in some include sleepiness and once asleep, sustained sleep.~Prazosin: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
181458|NCT01637272|B1|Baseline|SOM230|Subjects with dumping syndrome treated with pasireotide
181459|NCT01637272|P1|Participant Flow|SOM230|Subjects with dumping syndrome treated with pasireotide
181460|NCT01637272|O4|Outcome|SOM LAR 40mg|Subjects with dumping syndrome treated with pasireotide LAR 40mg
181461|NCT01637272|O3|Outcome|SOM LAR 30mg|Subjects with dumping syndrome treated with pasireotide LAR 30mg
181462|NCT01637272|O2|Outcome|SOM LAR 20mg|Subjects with dumping syndrome treated with pasireotide LAR 20mg
181463|NCT01637272|O1|Outcome|SOM LAR 10mg|Subjects with dumping syndrome treated with pasireotide LAR 10mg
181464|NCT01637272|O5|Outcome|SOM LAR 60mg|Subjects with dumping syndrome treated with pasireotide LAR 60mg
181465|NCT01637272|O4|Outcome|SOM LAR 40mg|Subjects with dumping syndrome treated with pasireotide LAR 40mg
181466|NCT01637272|O3|Outcome|SOM LAR 30mg|Subjects with dumping syndrome treated with pasireotide LAR 30mg
181467|NCT01637272|O2|Outcome|SOM LAR 20mg|Subjects with dumping syndrome treated with pasireotide LAR 20mg
181468|NCT01637272|O1|Outcome|SOM LAR 10mg|Subjects with dumping syndrome treated with pasireotide LAR 10mg
181469|NCT01637272|O2|Outcome|SOM LAR 20mg|Subjects with dumping syndrome treated with pasireotide LAR 20mg
181470|NCT01637272|O1|Outcome|SOM LAR 10mg|Subjects with dumping syndrome treated with pasireotide LAR 10mg
181471|NCT01637272|O2|Outcome|SOM LAR 20mg|Subjects with dumping syndrome treated with pasireotide LAR 20mg
181472|NCT01637272|O1|Outcome|SOM LAR 10mg|Subjects with dumping syndrome treated with pasireotide LAR 10mg
181473|NCT01637272|O4|Outcome|SOM sc 200 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
181474|NCT01637272|O3|Outcome|SOM sc 150 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 150 ug t.i.d. for 3 months
181475|NCT01637272|O2|Outcome|SOM sc 100 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 100 ug t.i.d. for 3 months
181476|NCT01637272|O1|Outcome|SOM sc 50 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 50 ug t.i.d. for 3 months
181477|NCT01637272|O4|Outcome|SOM sc 200 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
181478|NCT01637272|O3|Outcome|SOM sc 150 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 150 ug t.i.d. for 3 months
181479|NCT01637272|O2|Outcome|SOM sc 100 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 100 ug t.i.d. for 3 months
181480|NCT01637272|O1|Outcome|SOM sc 50 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 50 ug t.i.d. for 3 months
181481|NCT01637272|O4|Outcome|SOM sc 200 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
181482|NCT01637272|O3|Outcome|SOM sc 150 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 150 ug t.i.d. for 3 months
181483|NCT01637272|O2|Outcome|SOM sc 100 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 100 ug t.i.d. for 3 months
181484|NCT01637272|O1|Outcome|SOM sc 50 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 50 ug t.i.d. for 3 months
181485|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
181486|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
181487|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
181488|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
181489|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
181490|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
181491|NCT01637272|O3|Outcome|SOM230 - 8 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
181492|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
181493|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
181494|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
181495|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
181496|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
181497|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
181498|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
181499|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
181500|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
181501|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
181502|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
181503|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
181504|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
181505|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
181506|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
181507|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
181508|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
181509|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
181510|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
181511|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
181512|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
181513|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
181514|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
181515|NCT01637272|O2|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
181516|NCT01637272|O1|Outcome|SOM230- 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M)followed by pasireotide LAR (3M) for a total of 6 months
181517|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
181518|NCT01637272|E2|Reported Event|LAR Phase|LAR phase was made up of subjects with dumping syndrome who completed the s.c. phase, entered the LAR phase and were treated with pasireotide LAR
181519|NCT01637272|E1|Reported Event|s.c. Phase|s.c. phase was made up of subjects with dumping syndrome who entered the study and were treated with pasireotide s.c.
181520|NCT01637246|B1|Baseline|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
181521|NCT01637246|P1|Participant Flow|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
181522|NCT01637246|O1|Outcome|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
181523|NCT01637246|O1|Outcome|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
181524|NCT01637246|O1|Outcome|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
181525|NCT01637246|O1|Outcome|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
181526|NCT01637246|O1|Outcome|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
181527|NCT01637246|E1|Reported Event|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
181528|NCT01637090|B1|Baseline|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
181529|NCT01637090|P1|Participant Flow|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
181550|NCT01637077|O1|Outcome|Arm I (Pregabalin)|Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181551|NCT01637077|O2|Outcome|Arm II (Placebo)|Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181793|NCT01636076|O1|Outcome|QMF149 (Analyte Mometasone Furoate)|Assay Analyte: MOMETASONE FUROATE, component of QMF 149 mixture
181530|NCT01637090|O1|Outcome|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
181531|NCT01637090|O1|Outcome|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
181532|NCT01637090|O1|Outcome|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
181533|NCT01637090|O1|Outcome|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
181534|NCT01637090|O1|Outcome|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
181535|NCT01637090|E1|Reported Event|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
181536|NCT01637077|B3|Baseline|Total|Total of all reporting groups
181537|NCT01637077|B2|Baseline|Arm II (Placebo)|Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181538|NCT01637077|B1|Baseline|Arm I (Pregabalin)|Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181539|NCT01637077|P2|Participant Flow|Arm II (Placebo)|Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181540|NCT01637077|P1|Participant Flow|Arm I (Pregabalin)|Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181541|NCT01637077|O2|Outcome|Arm II (Placebo)|Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181542|NCT01637077|O1|Outcome|Arm I (Pregabalin)|Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181543|NCT01637077|O2|Outcome|Arm II (Placebo)|Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181544|NCT01637077|O1|Outcome|Arm I (Pregabalin)|Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181545|NCT01637077|O2|Outcome|Arm II (Placebo)|Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181546|NCT01637077|O1|Outcome|Arm I (Pregabalin)|Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181547|NCT01637077|O2|Outcome|Arm II (Placebo)|Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181548|NCT01637077|O1|Outcome|Arm I (Pregabalin)|Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181549|NCT01637077|O2|Outcome|Arm II (Placebo)|Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181552|NCT01637077|O1|Outcome|Arm I (Pregabalin)|Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181553|NCT01637077|O2|Outcome|Arm II (Placebo)|Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181554|NCT01637077|O1|Outcome|Arm I (Pregabalin)|Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181555|NCT01637077|O2|Outcome|Arm II (Placebo)|Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181556|NCT01637077|O1|Outcome|Arm I (Pregabalin)|Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181557|NCT01637077|O2|Outcome|Arm II (Placebo)|Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181558|NCT01637077|O1|Outcome|Arm I (Pregabalin)|Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181559|NCT01637077|O2|Outcome|Arm II (Placebo)|Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181560|NCT01637077|O1|Outcome|Arm I (Pregabalin)|Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181561|NCT01637077|O2|Outcome|Arm II (Placebo)|Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181562|NCT01637077|O1|Outcome|Arm I (Pregabalin)|Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181563|NCT01637077|E2|Reported Event|Arm II (Placebo)|Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181564|NCT01637077|E1|Reported Event|Arm I (Pregabalin)|Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
181565|NCT01636986|B3|Baseline|Total|Total of all reporting groups
181566|NCT01636986|B2|Baseline|1DAVM|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
181567|NCT01636986|B1|Baseline|DAILIES TOTAL1|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
181568|NCT01636986|P2|Participant Flow|1DAVM|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
181569|NCT01636986|P1|Participant Flow|DAILIES TOTAL1|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
181570|NCT01636986|O2|Outcome|1DAVM|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
181571|NCT01636986|O1|Outcome|DAILIES TOTAL1|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
181572|NCT01636986|E2|Reported Event|1DAVM|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
181573|NCT01636986|E1|Reported Event|DAILIES TOTAL1|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
181574|NCT01636960|B1|Baseline|Participants Receiving PegIFN Alfa-2b|Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
181575|NCT01636960|P1|Participant Flow|Participants Receiving PegIFN Alfa-2b|Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
181576|NCT01636960|O1|Outcome|Participants Receiving PegIFN Alfa-2b|Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
181577|NCT01636960|O1|Outcome|Participants Receiving PegIFN Alfa-2b|Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
181578|NCT01636960|O1|Outcome|Participants Receiving PegIFN Alfa-2b|Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
181579|NCT01636960|E1|Reported Event|Participants Receiving PegIFN Alfa-2b|Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
181580|NCT01636947|B3|Baseline|Total|Total of all reporting groups
181581|NCT01636947|B2|Baseline|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
181582|NCT01636947|B1|Baseline|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
181583|NCT01636947|P2|Participant Flow|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
181584|NCT01636947|P1|Participant Flow|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule by mouth (PO) once daily (QD) on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg intravenously (IV) QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO twice daily (BID) on Days 2 and 3.
181585|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
181789|NCT01636076|O1|Outcome|QMF 149 Anaylyte: Mometasone Furorate|Mometasone furoate as a component of QMF149F
181790|NCT01636076|O2|Outcome|QMF149 Analyte: Indacaterol Acetate|QAB149: indacaterol acetate as a component of QMF149F
181586|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
181587|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
181588|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
181589|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
181590|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
181591|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
181592|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
181593|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
181594|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
181595|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
181596|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
181597|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
181598|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
181599|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
181600|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
181601|NCT01636947|E2|Reported Event|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
181602|NCT01636947|E1|Reported Event|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
181603|NCT01636882|B1|Baseline|CVA21|"Dose of CAVATAK up to 3 x 10⁸ TCID50 for an additional 9 treatments at 3-week intervals~CVA21"
181604|NCT01636882|P1|Participant Flow|CVA21|Dose of CVA21 up to 3 x 10⁸ TCID50 for an additional 9 treatments at 3-week intervals
181605|NCT01636882|O1|Outcome|CVA21|Dose of CVA21 up to 3 x 10⁸ TCID50 for an additional 9 treatments at 3-week intervals
181606|NCT01636882|E1|Reported Event|CVA21|Dose of CVA21 up to 3 x 10⁸ TCID50 for an additional 9 treatments at 3-week intervals
181607|NCT01636778|B1|Baseline|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
181608|NCT01636778|P3|Participant Flow|Eltrombopag + Antiviral Therapy: Follow-up Period After Part|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
181609|NCT01636778|P2|Participant Flow|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
191718|NCT01595386|B3|Baseline|Total|Total of all reporting groups
181610|NCT01636778|P1|Participant Flow|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
181611|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
181612|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
181613|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
181614|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
181615|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
181616|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
181617|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
181618|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181619|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
181620|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
181621|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181622|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
181623|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
181624|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181625|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
181626|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
181627|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181628|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
181629|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
181630|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181631|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
181632|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
181633|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181634|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
181635|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
181636|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181637|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
181638|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
181639|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181791|NCT01636076|O1|Outcome|QMF149 Analyte: Mometasone Furoate|Mometasone furoate as part of QMF149F
181640|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
181641|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
181642|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181643|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
181644|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
181645|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181646|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181647|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181648|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181649|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181650|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181651|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181652|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181653|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181654|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181655|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181792|NCT01636076|O2|Outcome|QMF149 (Analyte Indacaterol Acetate)|Assay Analyte: QAB149 (Indacaterol acetate), component of QMF 149 mixture
181656|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181657|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181658|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181659|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181660|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181661|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
181662|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181663|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
181664|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181665|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
181666|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
181667|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181668|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
181669|NCT01636778|E3|Reported Event|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
181670|NCT01636778|E2|Reported Event|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
181671|NCT01636778|E1|Reported Event|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of &lt;80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was &lt;100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained &lt;100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts &gt;=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts &gt;=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
181672|NCT01636765|B1|Baseline|All Participants|Patients with facial erythema associated with rosacea. There was no intervention in this study.
181673|NCT01636765|P1|Participant Flow|All Participants|Patients with facial erythema associated with rosacea. There was no intervention in this study.
181674|NCT01636765|O1|Outcome|All Participants|Patients with facial erythema associated with rosacea. There was no intervention in this study.
181675|NCT01636765|O1|Outcome|All Participants|Patients with facial erythema associated with rosacea. There was no intervention in this study.
181676|NCT01636765|E1|Reported Event|All Participants|Patients with facial erythema associated with rosacea. There was no intervention in this study.
181677|NCT01636713|B4|Baseline|Total|Total of all reporting groups
181678|NCT01636713|B3|Baseline|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
181679|NCT01636713|B2|Baseline|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
181680|NCT01636713|B1|Baseline|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
181681|NCT01636713|P3|Participant Flow|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
181682|NCT01636713|P2|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
181683|NCT01636713|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
181684|NCT01636713|O3|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
181685|NCT01636713|O2|Outcome|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
181686|NCT01636713|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
181687|NCT01636713|O3|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
181688|NCT01636713|O2|Outcome|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
181689|NCT01636713|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
181690|NCT01636713|O3|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
181691|NCT01636713|O2|Outcome|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
181692|NCT01636713|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
181693|NCT01636713|E3|Reported Event|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
181694|NCT01636713|E2|Reported Event|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
181695|NCT01636713|E1|Reported Event|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
181696|NCT01636661|B3|Baseline|Total|Total of all reporting groups
181697|NCT01636661|B2|Baseline|Sham tDCS|"tDCS equipment set to placebo setting.~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
181698|NCT01636661|B1|Baseline|Transcranial Direct Current Stimulation|"Receiving active tDCS~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
181699|NCT01636661|P2|Participant Flow|Sham tDCS|"tDCS equipment set to placebo setting.~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
181700|NCT01636661|P1|Participant Flow|Transcranial Direct Current Stimulation|"Receiving active tDCS~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
181701|NCT01636661|O2|Outcome|Sham tDCS|"tDCS equipment set to placebo setting.~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
181702|NCT01636661|O1|Outcome|Transcranial Direct Current Stimulation|"Receiving active tDCS~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
181703|NCT01636661|O2|Outcome|Sham tDCS|"tDCS equipment set to placebo setting.~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
181704|NCT01636661|O1|Outcome|Transcranial Direct Current Stimulation|"Receiving active tDCS~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
181705|NCT01636661|E2|Reported Event|Sham tDCS|"tDCS equipment set to placebo setting.~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
181706|NCT01636661|E1|Reported Event|Transcranial Direct Current Stimulation|"Receiving active tDCS~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
181707|NCT01636466|B3|Baseline|Total|Total of all reporting groups
181708|NCT01636466|B2|Baseline|Control|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started.
181709|NCT01636466|B1|Baseline|Everolimus Conversion|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.
181710|NCT01636466|P2|Participant Flow|Control|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started.
181711|NCT01636466|P1|Participant Flow|Everolimus Conversion|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.
181712|NCT01636466|O2|Outcome|Control|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started.
181713|NCT01636466|O1|Outcome|Everolimus Conversion|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.
181714|NCT01636466|O2|Outcome|Control|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started.
181715|NCT01636466|O1|Outcome|Everolimus Conversion|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.
181716|NCT01636466|E2|Reported Event|Control|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started.
181717|NCT01636466|E1|Reported Event|Everolimus Conversion|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.
181718|NCT01636414|B4|Baseline|Total|Total of all reporting groups
181719|NCT01636414|B3|Baseline|Tranexamic Drain|Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
181720|NCT01636414|B2|Baseline|Re-infusion Drain|Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
181721|NCT01636414|B1|Baseline|Hemovac Drain|Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.
181722|NCT01636414|P3|Participant Flow|Tranexamic Drain|Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
181723|NCT01636414|P2|Participant Flow|Re-infusion Drain|Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
181724|NCT01636414|P1|Participant Flow|Hemovac Drain|Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.
181725|NCT01636414|O3|Outcome|Tranexamic Drain|Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
181726|NCT01636414|O2|Outcome|Re-infusion Drain|Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
181727|NCT01636414|O1|Outcome|Hemovac Drain|Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.
181728|NCT01636414|O3|Outcome|Tranexamic Drain|Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
181729|NCT01636414|O2|Outcome|Re-infusion Drain|Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
181730|NCT01636414|O1|Outcome|Hemovac Drain|Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.
181731|NCT01636414|E3|Reported Event|Tranexamic Drain|Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
181732|NCT01636414|E2|Reported Event|Re-infusion Drain|Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
181733|NCT01636414|E1|Reported Event|Hemovac Drain|Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.
181734|NCT01636362|B1|Baseline|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.~Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
181735|NCT01636362|P1|Participant Flow|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.~Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
181736|NCT01636362|O1|Outcome|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.~Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
181737|NCT01636362|O1|Outcome|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.~Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
181738|NCT01636362|O1|Outcome|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.~Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
181739|NCT01636362|E1|Reported Event|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.~Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
181740|NCT01636258|B3|Baseline|Total|Total of all reporting groups
181741|NCT01636258|B2|Baseline|Arm B: Intervention Group|"Arm includes diet instruction, exercise, stress management, and culinary education~Exercise : Every week~Diet : Every other week~Culinary education : Every other week~Stress Management : Every other week"
181742|NCT01636258|B1|Baseline|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
181743|NCT01636258|P2|Participant Flow|Arm B: Intervention Group|"Arm includes diet instruction, exercise, stress management, and culinary education~Exercise : Every week~Diet : Every other week~Culinary education : Every other week~Stress Management : Every other week"
181744|NCT01636258|P1|Participant Flow|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
181745|NCT01636258|O2|Outcome|Arm B|"Arm includes diet instruction, exercise, stress management, and culinary education~Stress Management: Every other week~Diet: Every other week~Exercise: Every week~Culinary education: Every other week"
181746|NCT01636258|O1|Outcome|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
181747|NCT01636258|O2|Outcome|Arm B|"Arm includes diet instruction, exercise, stress management, and culinary education~Stress Management: Every other week~Diet: Every other week~Exercise: Every week~Culinary education: Every other week"
181748|NCT01636258|O1|Outcome|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
181749|NCT01636258|O2|Outcome|Arm B|"Arm includes diet instruction, exercise, stress management, and culinary education~Stress Management: Every other week~Diet: Every other week~Exercise: Every week~Culinary education: Every other week"
181750|NCT01636258|O1|Outcome|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
181751|NCT01636258|O2|Outcome|Arm B: Intervention Group|"Arm includes diet instruction, exercise, stress management, and culinary education~Exercise : Every week~Diet : Every other week~Culinary education : Every other week~Stress Management : Every other week"
181752|NCT01636258|O1|Outcome|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
181753|NCT01636258|O2|Outcome|Arm B: Intervention Group|"Arm includes diet instruction, exercise, stress management, and culinary education~Exercise : Every week~Diet : Every other week~Culinary education : Every other week~Stress Management : Every other week"
181754|NCT01636258|O1|Outcome|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
181755|NCT01636258|E2|Reported Event|Arm B: Intervention Group|"Arm includes diet instruction, exercise, stress management, and culinary education~Exercise : Every week~Diet : Every other week~Culinary education : Every other week~Stress Management : Every other week"
181756|NCT01636258|E1|Reported Event|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
181757|NCT01636206|B3|Baseline|Total|Total of all reporting groups
181758|NCT01636206|B2|Baseline|Lifitegrast|
181759|NCT01636206|B1|Baseline|Placebo|
181760|NCT01636206|P2|Participant Flow|Lifitegrast|
181761|NCT01636206|P1|Participant Flow|Placebo|
181762|NCT01636206|O2|Outcome|Lifitegrast|
181763|NCT01636206|O1|Outcome|Placebo|
181764|NCT01636206|E2|Reported Event|Lifitegrast|
181765|NCT01636206|E1|Reported Event|Placebo|
181766|NCT01636102|B3|Baseline|Total|Total of all reporting groups
181767|NCT01636102|B2|Baseline|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
181768|NCT01636102|B1|Baseline|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
181769|NCT01636102|P2|Participant Flow|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
181770|NCT01636102|P1|Participant Flow|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
181771|NCT01636102|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
181772|NCT01636102|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
181773|NCT01636102|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
181774|NCT01636102|O1|Outcome|18 - 60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
181775|NCT01636102|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
181776|NCT01636102|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
181777|NCT01636102|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
181778|NCT01636102|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
181779|NCT01636102|E2|Reported Event|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
181780|NCT01636102|E1|Reported Event|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
181781|NCT01636076|B3|Baseline|Total|Total of all reporting groups
181782|NCT01636076|B2|Baseline|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
181783|NCT01636076|B1|Baseline|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181784|NCT01636076|P2|Participant Flow|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
181785|NCT01636076|P1|Participant Flow|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181786|NCT01636076|O2|Outcome|QMF149 Analyte QAB149|QMF149 analyte QAB149 ( indacaterol acetate)
181787|NCT01636076|O1|Outcome|QMF149 Analyte Mometasone Furoate|QMF149 Mometasone furoate analyte from mixture
181788|NCT01636076|O2|Outcome|QMF149 Analyte: Indacaterol Acetate|QAB149: indacaterol acetate as a component of QMF149F
181794|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
181795|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181796|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
181797|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181798|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
181799|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181800|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
181801|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181802|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
181803|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181804|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
181805|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181806|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
181807|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181808|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
181809|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181810|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
181811|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181812|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
181813|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181814|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
181815|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181816|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
181817|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181818|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
181819|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181820|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
181821|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181822|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
181823|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181824|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
181825|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181826|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
181827|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181828|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
181829|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181830|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
181831|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181832|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
181833|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181834|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
181835|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181836|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
181837|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181838|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
181839|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181840|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
181841|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181842|NCT01636076|E2|Reported Event|SALM/FLUT|SALM/FLUT
181843|NCT01636076|E1|Reported Event|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
181844|NCT01636063|B3|Baseline|Total|Total of all reporting groups
181845|NCT01636063|B2|Baseline|Misoprostol|"Subjects will receive 400 mcg of buccal misoprostol for the purposes of cervical preparation.~Misoprostol: Misoprostol 400 mcg buccally once 3 hours prior to abortion procedure"
181846|NCT01636063|B1|Baseline|Mifepristone|"Subjects will receive 200 mg of capsulized mifepristone orally for the purpose of cervical preparation before surgical abortion~Mifepristone: Mifepristone 200 mg capsulized orally once 24-48 hours prior to abortion procedure"
181847|NCT01636063|P2|Participant Flow|Misoprostol|"Subjects will receive 400 mcg of buccal misoprostol for the purposes of cervical preparation.~Misoprostol: Misoprostol 400 mcg buccally once 3 hours prior to abortion procedure"
181848|NCT01636063|P1|Participant Flow|Mifepristone|"Subjects will receive 200 mg of capsulized mifepristone orally for the purpose of cervical preparation before surgical abortion~Mifepristone: Mifepristone 200 mg capsulized orally once 24-48 hours prior to abortion procedure"
181849|NCT01636063|O2|Outcome|Misoprostol|"Subjects will receive 400 mcg of buccal misoprostol for the purposes of cervical preparation.~Misoprostol: Misoprostol 400 mcg buccally once 3 hours prior to abortion procedure"
181850|NCT01636063|O1|Outcome|Mifepristone|"Subjects will receive 200 mg of capsulized mifepristone orally for the purpose of cervical preparation before surgical abortion~Mifepristone: Mifepristone 200 mg capsulized orally once 24-48 hours prior to abortion procedure"
181851|NCT01636063|E2|Reported Event|Misoprostol|"Subjects will receive 400 mcg of buccal misoprostol for the purposes of cervical preparation.~Misoprostol: Misoprostol 400 mcg buccally once 3 hours prior to abortion procedure"
181852|NCT01636063|E1|Reported Event|Mifepristone|"Subjects will receive 200 mg of capsulized mifepristone orally for the purpose of cervical preparation before surgical abortion~Mifepristone: Mifepristone 200 mg capsulized orally once 24-48 hours prior to abortion procedure"
181853|NCT01635933|B3|Baseline|Total|Total of all reporting groups
181854|NCT01635933|B2|Baseline|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
181855|NCT01635933|B1|Baseline|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
181856|NCT01635933|P2|Participant Flow|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
181857|NCT01635933|P1|Participant Flow|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
181858|NCT01635933|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
181859|NCT01635933|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
181860|NCT01635933|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
181861|NCT01635933|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
181862|NCT01635933|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
181863|NCT01635933|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
181864|NCT01635933|E2|Reported Event|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
181865|NCT01635933|E1|Reported Event|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
181866|NCT01635920|B3|Baseline|Total|Total of all reporting groups
181867|NCT01635920|B2|Baseline|AIR OPTIX® AQUA|Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
181868|NCT01635920|B1|Baseline|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
181869|NCT01635920|P2|Participant Flow|AIR OPTIX® AQUA|Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
181870|NCT01635920|P1|Participant Flow|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
181871|NCT01635920|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
181872|NCT01635920|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with print worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
181873|NCT01635920|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
181874|NCT01635920|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
181875|NCT01635920|E2|Reported Event|AIR OPTIX® AQUA|Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
181876|NCT01635920|E1|Reported Event|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
181877|NCT01635881|B1|Baseline|Emerge|Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter
181878|NCT01635881|P1|Participant Flow|Emerge|Single arm with investigational Emerge™ 1.20 mm percutaneous transluminal coronary angioplasty (PTCA) Dilatation Catheter
181879|NCT01635881|O1|Outcome|Emerge|Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter
181880|NCT01635881|O1|Outcome|Emerge|Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter
181881|NCT01635881|E1|Reported Event|Emerge|Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter
181882|NCT01635855|B1|Baseline|Belotero®: Hyaluronic Acid Dermal Filler|Belotero®: Hyaluronic acid dermal filler
181883|NCT01635855|P1|Participant Flow|Belotero®: Hyaluronic Acid Dermal Filler|Belotero®: Hyaluronic acid dermal filler
181884|NCT01635855|O1|Outcome|Belotero|Belotero®: Hyaluronic acid dermal filler
181885|NCT01635855|E1|Reported Event|Belotero®: Hyaluronic Acid Dermal Filler|Belotero®: Hyaluronic acid dermal filler
181886|NCT01635764|B6|Baseline|Total|Total of all reporting groups
181887|NCT01635764|B5|Baseline|PBO/PBO/EW|All participants who received placebo in both Period A and Period B in prior phase 3 study M11-810.
181888|NCT01635764|B4|Baseline|PBO/EW/EW|All participants who received placebo in Period A and adalimumab 40 mg every week (EW) in Period B in prior phase 3 study M11-313.
181889|NCT01635764|B3|Baseline|EW/PBO/EW|All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
181890|NCT01635764|B2|Baseline|EW/EOW/EW|All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
181891|NCT01635764|B1|Baseline|EW/EW/EW|All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
181892|NCT01635764|P1|Participant Flow|Adalimumab Every Week|Adalimumab 40 mg every week.
181893|NCT01635764|O1|Outcome|PBO/EW/EW|All participants who received placebo in Period A and adalimumab 40 mg every week (EW) in Period B in prior phase 3 study M11-313.
181894|NCT01635764|O3|Outcome|PBO/PBO/EW|All participants who received placebo in both Period A and Period B in prior phase 3 study M11-810.
181895|NCT01635764|O2|Outcome|EW/PBO/EW|All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
181896|NCT01635764|O1|Outcome|EW/EOW/EW|All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
181897|NCT01635764|O1|Outcome|EW/EW/EW|All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
181898|NCT01635764|O1|Outcome|PBO/EW/EW|All participants who received placebo in Period A and adalimumab 40 mg every week (EW) in Period B in prior phase 3 study M11-313.
181899|NCT01635764|O3|Outcome|PBO/PBO/EW|All participants who received placebo in both Period A and Period B in prior phase 3 study M11-810.
181900|NCT01635764|O2|Outcome|EW/PBO/EW|All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
181901|NCT01635764|O1|Outcome|EW/EOW/EW|All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
181902|NCT01635764|O1|Outcome|EW/EW/EW|All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
181903|NCT01635764|O1|Outcome|PBO/EW/EW|All participants who received placebo in Period A and adalimumab 40 mg every week (EW) in Period B in prior phase 3 study M11-313.
181904|NCT01635764|O3|Outcome|PBO/PBO/EW|All participants who received placebo in both Period A and Period B in prior phase 3 study M11-810.
181905|NCT01635764|O2|Outcome|EW/PBO/EW|All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
181906|NCT01635764|O1|Outcome|EW/EOW/EW|All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
181907|NCT01635764|O1|Outcome|EW/EW/EW|All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
181908|NCT01635764|O1|Outcome|PBO/EW/EW|All participants who received placebo in Period A and adalimumab 40 mg every week (EW) in Period B in prior phase 3 study M11-313.
181909|NCT01635764|O3|Outcome|PBO/PBO/EW|All participants who received placebo in both Period A and Period B in prior phase 3 study M11-810.
181910|NCT01635764|O2|Outcome|EW/PBO/EW|All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
181911|NCT01635764|O1|Outcome|EW/EOW/EW|All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
181912|NCT01635764|O1|Outcome|EW/EW/EW|All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
181913|NCT01635764|O1|Outcome|PBO/PBO/EW|All participants who received placebo in both Period A and Period B in prior phase 3 study M11-810.
181914|NCT01635764|O1|Outcome|PBO/EW/EW|All participants who received placebo in Period A and adalimumab 40 mg every week (EW) in Period B in prior phase 3 study M11-313.
181915|NCT01635764|O3|Outcome|EW/PBO/EW|All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
181916|NCT01635764|O2|Outcome|EW/EOW/EW|All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
181917|NCT01635764|O1|Outcome|EW/EW/EW|All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
181918|NCT01635764|E1|Reported Event|All Adalimumab|Participants who received at least 1 dose of adalimumab (40 mg every week) in M12-555.
181919|NCT01635504|B1|Baseline|HIV Posterior Cheek Enlargement Group|Patients with HIV posterior cheek enlargement treated with botulinum toxin A
181920|NCT01635504|P1|Participant Flow|Botulinum Toxin A|Botulinum toxin A 50 units per side of the posterior cheek enlargement, injected into the masseter muscle and parotid gland (10 units into 5 points of the posterior cheek enlargement per side, giving a total of 100 units per patient)
181921|NCT01635504|O1|Outcome|HIV Posterior Cheek Enlargement Group|Patients with HIV posterior cheek enlargement treated with botulinum toxin A
181922|NCT01635504|O1|Outcome|HIV Posterior Cheek Enlargement Group|Patients with HIV posterior cheek enlargement treated with botulinum toxin A
181923|NCT01635504|E1|Reported Event|HIV Posterior Cheek Enlargement Group|Injected with botulinum toxin A
181924|NCT01635439|B3|Baseline|Total|Total of all reporting groups
181925|NCT01635439|B2|Baseline|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
181926|NCT01635439|B1|Baseline|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
181927|NCT01635439|P2|Participant Flow|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
181928|NCT01635439|P1|Participant Flow|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
181929|NCT01635439|O2|Outcome|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
181930|NCT01635439|O1|Outcome|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
181931|NCT01635439|O2|Outcome|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
181932|NCT01635439|O1|Outcome|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
181933|NCT01635439|O2|Outcome|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
181934|NCT01635439|O1|Outcome|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
181935|NCT01635439|O2|Outcome|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
181936|NCT01635439|O1|Outcome|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
181937|NCT01635439|O2|Outcome|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
181938|NCT01635439|O1|Outcome|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
181939|NCT01635439|E2|Reported Event|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
181940|NCT01635439|E1|Reported Event|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
181941|NCT01635244|B4|Baseline|Total|Total of all reporting groups
181942|NCT01635244|B3|Baseline|Trifecta|"Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
181943|NCT01635244|B2|Baseline|Magna Ease|"Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
181944|NCT01635244|B1|Baseline|Freestyle|"Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
181945|NCT01635244|P3|Participant Flow|Trifecta|"Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
181946|NCT01635244|P2|Participant Flow|Magna Ease|"Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
181947|NCT01635244|P1|Participant Flow|Freestyle|"Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
181948|NCT01635244|O3|Outcome|Trifecta|"Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
181949|NCT01635244|O2|Outcome|Magna Ease|"Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
181950|NCT01635244|O1|Outcome|Freestyle|"Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
181951|NCT01635244|E3|Reported Event|Trifecta|"Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
181952|NCT01635244|E2|Reported Event|Magna Ease|"Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
181953|NCT01635244|E1|Reported Event|Freestyle|"Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
181954|NCT01635218|B4|Baseline|Total|Total of all reporting groups
181955|NCT01635218|B3|Baseline|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
181956|NCT01635218|B2|Baseline|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
181957|NCT01635218|B1|Baseline|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
181958|NCT01635218|P3|Participant Flow|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
181959|NCT01635218|P2|Participant Flow|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
181960|NCT01635218|P1|Participant Flow|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
181961|NCT01635218|O3|Outcome|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
181962|NCT01635218|O2|Outcome|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
181963|NCT01635218|O1|Outcome|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
181964|NCT01635218|O3|Outcome|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
181965|NCT01635218|O2|Outcome|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
181966|NCT01635218|O1|Outcome|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
181967|NCT01635218|O3|Outcome|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
181968|NCT01635218|O2|Outcome|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
181989|NCT01635062|O1|Outcome|Calcitriol|Subjects have their plasma renin activity assessed at baseline while sodium restricted, and again after 2 weeks of randomized therapy with calcitriol (up to 0.75 mcg daily) or placebo.
181990|NCT01635062|E2|Reported Event|Placebo|"Subjects will receive placebo for 3 weeks.~Placebo: Subjects will receive placebo for 3 weeks."
182769|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
181969|NCT01635218|O1|Outcome|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
181970|NCT01635218|O3|Outcome|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
181971|NCT01635218|O2|Outcome|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
181972|NCT01635218|O1|Outcome|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
181973|NCT01635218|O3|Outcome|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
181974|NCT01635218|O2|Outcome|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
181975|NCT01635218|O1|Outcome|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
181976|NCT01635218|E3|Reported Event|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
181977|NCT01635218|E2|Reported Event|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded could be repeated at week 4."
181978|NCT01635218|E1|Reported Event|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
181979|NCT01635062|B3|Baseline|Total|Total of all reporting groups
181980|NCT01635062|B2|Baseline|Placebo|"Subjects will receive placebo for 3 weeks.~Subjects have their renin-angiotensin system, renal plasma flow, and urine protein assessed at baseline while sodium restricted and sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat assessments again while sodium restricted and sodium loaded."
181981|NCT01635062|B1|Baseline|Calcitriol|"Subjects will receive calcitriol (titrated up to 0.75 mcg daily) for 3 weeks.~Subjects have their renin-angiotensin system, renal plasma flow, and urine protein assessed at baseline while sodium restricted and sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat assessments again while sodium restricted and sodium loaded."
181982|NCT01635062|P2|Participant Flow|Placebo|"Subjects will receive placebo for 3 weeks.~Subjects have their renin-angiotensin system, renal plasma flow, and urine protein assessed at baseline while sodium restricted and sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat assessments again while sodium restricted and sodium loaded."
181983|NCT01635062|P1|Participant Flow|Calcitriol|"Subjects will receive calcitriol (titrated up to 0.75 mcg daily) for 3 weeks.~Subjects have their renin-angiotensin system, renal plasma flow, and urine protein assessed at baseline while sodium restricted and sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat assessments again while sodium restricted and sodium loaded."
181984|NCT01635062|O2|Outcome|Placebo|Subjects have their urine protein assessed at baseline while sodium sodium loaded and again following 3 weeks of randomization to calcitriol (up to 0.75 mcg daily) or placebo.
181985|NCT01635062|O1|Outcome|Calcitriol|Subjects have their urine protein assessed at baseline while sodium sodium loaded and again following 3 weeks of randomization to calcitriol (up to 0.75 mcg daily) or placebo.
181986|NCT01635062|O2|Outcome|Placebo|Subjects have their renal plasma flow assessed at baseline while sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat renal plasma flow assessments again while sodium loaded.
181987|NCT01635062|O1|Outcome|Calcitriol|Subjects have their renal plasma flow assessed at baseline while sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat renal plasma flow assessments again while sodium loaded.
181988|NCT01635062|O2|Outcome|Placebo|Subjects have their plasma renin activity assessed at baseline while sodium restricted, and again after 2 weeks of randomized therapy with calcitriol (up to 0.75 mcg daily) or placebo.
181991|NCT01635062|E1|Reported Event|Calcitriol|"Subjects will receive calcitriol (titrated up to 0.75 mcg daily) for 3 weeks.~Calcitriol: Subjects will receive calcitriol (up to 0.75 mcg daily) for 3 weeks."
181992|NCT01634854|B3|Baseline|Total|Total of all reporting groups
181993|NCT01634854|B2|Baseline|Intravenous Oxytocin|"2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous~Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous"
181994|NCT01634854|B1|Baseline|Vaginal Misoprostol|"Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal~Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal"
181995|NCT01634854|P2|Participant Flow|Intravenous Oxytocin|"2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous~Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous"
181996|NCT01634854|P1|Participant Flow|Vaginal Misoprostol|"Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal~Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal"
181997|NCT01634854|O2|Outcome|Intravenous Oxytocin|"2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous~Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous"
181998|NCT01634854|O1|Outcome|Vaginal Misoprostol|"Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal~Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal"
181999|NCT01634854|O2|Outcome|Intravenous Oxytocin|"2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous~Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous"
182000|NCT01634854|O1|Outcome|Vaginal Misoprostol|"Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal~Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal"
182001|NCT01634854|O2|Outcome|Intravenous Oxytocin|"2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous~Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous"
182002|NCT01634854|O1|Outcome|Vaginal Misoprostol|"Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal~Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal"
182003|NCT01634854|O2|Outcome|Intravenous Oxytocin|"2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous~Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous"
182004|NCT01634854|O1|Outcome|Vaginal Misoprostol|"Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal~Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal"
182005|NCT01634854|O2|Outcome|Intravenous Oxytocin|"2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous~Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous"
182006|NCT01634854|O1|Outcome|Vaginal Misoprostol|"Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal~Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal"
182007|NCT01634854|O2|Outcome|Intravenous Oxytocin|"2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous~Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous"
182008|NCT01634854|O1|Outcome|Vaginal Misoprostol|"Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal~Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal"
182009|NCT01634854|O2|Outcome|Intravenous Oxytocin|"2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous~Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous"
182079|NCT01634256|O1|Outcome|Fermented Turmeric|Oral intake Fermented turmeric (3.0g/day) for 12weeks.
182080|NCT01634256|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
182081|NCT01634256|O1|Outcome|Fermented Turmeric|Oral intake Fermented turmeric (3.0g/day) for 12weeks.
182010|NCT01634854|O1|Outcome|Vaginal Misoprostol|"Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal~Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal"
182011|NCT01634854|E2|Reported Event|Intravenous Oxytocin|"2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous~Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.~Route of administration: intravenous"
182012|NCT01634854|E1|Reported Event|Vaginal Misoprostol|"Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal~Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal"
182013|NCT01634659|B3|Baseline|Total|Total of all reporting groups
182014|NCT01634659|B2|Baseline|Narafilcon B, Then Delefilcon A|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
182015|NCT01634659|B1|Baseline|Delefilcon A, Then Narafilcon B|Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
182016|NCT01634659|P2|Participant Flow|Narafilcon B, Then Delefilcon A|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
182017|NCT01634659|P1|Participant Flow|Delefilcon A, Then Narafilcon B|Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
182018|NCT01634659|O2|Outcome|Narafilcon B|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
182019|NCT01634659|O1|Outcome|Delefilcon A|Delefilcon A contact lenses (DAILIES TOTAL1®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
182020|NCT01634659|O2|Outcome|Narafilcon B|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
182021|NCT01634659|O1|Outcome|Delefilcon A|Delefilcon A contact lenses (DAILIES TOTAL1®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
182022|NCT01634659|O2|Outcome|Narafilcon B|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
182023|NCT01634659|O1|Outcome|Delefilcon A|Delefilcon A contact lenses (DAILIES TOTAL1®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
182024|NCT01634659|E2|Reported Event|Narafilcon B|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
182025|NCT01634659|E1|Reported Event|Delefilcon A|Delefilcon A contact lenses (DAILIES TOTAL1®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
182026|NCT01634620|B1|Baseline|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
182027|NCT01634620|P1|Participant Flow|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
182028|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
182029|NCT01634620|O3|Outcome|High FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~High FeNO subjects are defined as subjects with FeNO levels > 50 parts per billion."
182030|NCT01634620|O2|Outcome|Moderate FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~Moderate FeNO is defined as subjects with FeNO levels >=25 parts per billion (ppb) or <=50 ppb."
182031|NCT01634620|O1|Outcome|Low FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~Low FeNo is defined as subjects with FeNo levels <25 parts per billion."
182032|NCT01634620|O3|Outcome|High FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~High FeNO subjects are defined as subjects with FeNO levels > 50 parts per billion."
182033|NCT01634620|O2|Outcome|Moderate FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~Moderate FeNO is defined as subjects with FeNO levels >=25 parts per billion (ppb) or <=50 ppb."
182034|NCT01634620|O1|Outcome|Low FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~Low FeNo is defined as subjects with FeNo levels <25 parts per billion."
182035|NCT01634620|O3|Outcome|High FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements was performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~High FeNO subjects are defined as subjects with FeNO levels > 50 parts per billion."
182036|NCT01634620|O2|Outcome|Moderate FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~Moderate FeNO is defined as subjects with FeNO levels >=25 parts per billion (ppb) or <=50 ppb."
182037|NCT01634620|O1|Outcome|Low FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~Low FeNo is defined as subjects with FeNo levels <25 parts per billion."
182038|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
182039|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
182040|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
182041|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
182042|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
182043|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
182044|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
182082|NCT01634256|E2|Reported Event|Placebo|Oral intake placebo(3.0g/day) for 12weeks
182083|NCT01634256|E1|Reported Event|Fermented Curcuma|Oral intake fermented curcuma (3.0g/day) for 12weeks.
182084|NCT01634243|B3|Baseline|Total|Total of all reporting groups
182045|NCT01634620|E1|Reported Event|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
182046|NCT01634555|B1|Baseline|Ramucirumab (IMC-1121B) and FOLFIRI|"Treatment is sequential. Ramucirumab (IMC-1121B) was administered before FOLFIRI (Irinotecan + Folinic acid + 5-Fluorouracil) during Cycles 2+~Ramucirumab (IMC-1121B): 8 mg/kg administered as IV infusion on Day 1 of each 2-week cycle (except Cycle 1)~Irinotecan: 180 mg/m² administered IV on Day 1 of each 2-week cycle~Folinic acid: 400 mg/m² administered IV on Day 1 of each 2-week cycle~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of each 2-week cycle, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of each cycle"
182047|NCT01634555|P1|Participant Flow|Ramucirumab (IMC-1121B) and FOLFIRI|"Treatment is sequential. Ramucirumab (IMC-1121B) was administered before FOLFIRI (Irinotecan + Folinic acid + 5-Fluorouracil) during Cycles 2+~Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered as an intravenous (IV) infusion on Day 1 of each 2-week cycle (except Cycle 1)~Irinotecan: 180 milligrams per square meter (mg/m²) administered IV on Day 1 of each 2-week cycle~Folinic acid: 400 mg/m² administered IV on Day 1 of each 2-week cycle~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of each cycle, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of each 2-week cycle"
182048|NCT01634555|O1|Outcome|Ramucirumab + FOLFIRI (Cycle 2)|"Ramucirumab (IMC-1121B): 8 mg/kg administered as IV infusion on Day 1 of Cycle 2 (2-week cycle)~Irinotecan: 180 mg/m² administered IV on Day 1 of both Cycles 1 and 2 (2-week cycle)~Folinic acid: 400 mg/m² administered IV on Day 1 of both Cycles 1 and 2 (2-week cycle)~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of Cycles 1 and 2, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of both Cycles 1 and 2 (2-week cycle)"
182049|NCT01634555|O1|Outcome|Ramucirumab + FOLFIRI (Cycle 2)|"Ramucirumab (IMC-1121B): 8 mg/kg administered as IV infusion on Day 1 of Cycle 2 (2-week cycle)~Irinotecan: 180 mg/m² administered IV on Day 1 of both Cycles 1 and 2 (2-week cycle)~Folinic acid: 400 mg/m² administered IV on Day 1 of both Cycles 1 and 2 (2-week cycle)~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of Cycles 1 and 2, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of both Cycles 1 and 2 (2-week cycle)"
182050|NCT01634555|O1|Outcome|FOLFIRI (Cycle 1)|"Irinotecan: 180 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)~Folinic acid: 400 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of Cycle 1 (2-week cycle)"
182051|NCT01634555|O1|Outcome|Ramucirumab + FOLFIRI (Cycle 2)|"Ramucirumab (IMC-1121B): 8 mg/kg administered as IV infusion on Day 1 of Cycle 2 (2-week cycle)~Irinotecan: 180 mg/m² administered IV on Day 1 of both Cycles 1 and 2 (2-week cycle)~Folinic acid: 400 mg/m² administered IV on Day 1 of both Cycles 1 and 2 (2-week cycle)~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of Cycles 1 and 2, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of both Cycles 1 and 2 (2-week cycle)"
182052|NCT01634555|O1|Outcome|FOLFIRI (Cycle 1)|"Irinotecan: 180 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)~Folinic acid: 400 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of Cycle 1 (2-week cycle)"
182053|NCT01634555|E1|Reported Event|Ramucirumab (IMC-1121B) and FOLFIRI|"Treatment is sequential. Ramucirumab (IMC-1121B) was administered before FOLFIRI (Irinotecan + Folinic acid + 5-Fluorouracil) during Cycles 2+~Ramucirumab (IMC-1121B): 8 mg/kg, administered as IV infusion on Day 1 of each 2-week cycle (except Cycle 1)~Irinotecan: 180 mg/m² administered IV on Day 1 of each 2-week cycle~Folinic acid: 400 mg/m² administered IV on Day 1 of each 2-week cycle~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of each 2-week cycle, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of each cycle"
182054|NCT01634360|B3|Baseline|Total|Total of all reporting groups
182055|NCT01634360|B2|Baseline|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
182056|NCT01634360|B1|Baseline|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
182057|NCT01634360|P2|Participant Flow|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
182085|NCT01634243|B2|Baseline|Advanced Parkinson's Disease|
182086|NCT01634243|B1|Baseline|Early-stage Parkinson's Disease|
182087|NCT01634243|P2|Participant Flow|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
182088|NCT01634243|P1|Participant Flow|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
182770|NCT01631825|E1|Reported Event|SPM 962|SPM 962 transdermal patch
182058|NCT01634360|P1|Participant Flow|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
182059|NCT01634360|O2|Outcome|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
182060|NCT01634360|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
182061|NCT01634360|O2|Outcome|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
182062|NCT01634360|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
182063|NCT01634360|O2|Outcome|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
182064|NCT01634360|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
182065|NCT01634360|E2|Reported Event|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
182066|NCT01634360|E1|Reported Event|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
182067|NCT01634256|B3|Baseline|Total|Total of all reporting groups
182068|NCT01634256|B2|Baseline|Placebo|
182069|NCT01634256|B1|Baseline|Fermented Curcuma|
182070|NCT01634256|P2|Participant Flow|Placebo|"Placebo(3times/day, 6capsules/day, 3g/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Fermented turmeric."
182071|NCT01634256|P1|Participant Flow|Fermented Turmeric|"Fermented turmeric(3times/day, 6capsules/day, 3g/day) for 12weeks~Fermented curcuma : Powdered Curcuma longa L., was produced through the fermentation of Aspergillus oryzae to 25 ˚ C for 36 hours."
182072|NCT01634256|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
182073|NCT01634256|O1|Outcome|Fermented Turmeric|Oral intake Fermented turmeric (3.0g/day) for 12weeks.
182074|NCT01634256|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
182075|NCT01634256|O1|Outcome|Fermented Turmeric|Oral intake Fermented turmeric (3.0g/day) for 12weeks.
182076|NCT01634256|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
182077|NCT01634256|O1|Outcome|Fermented Turmeric|Oral intake Fermented turmeric (3.0g/day) for 12weeks.
182078|NCT01634256|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
182089|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
182090|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
182091|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
182092|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
182093|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
182094|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
182095|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
182096|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
182097|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
182098|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
182099|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
182100|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
182101|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
182102|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
182103|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
182104|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
182105|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
182106|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
182107|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
182108|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
182109|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
182110|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
182111|NCT01634243|E2|Reported Event|Advanced Parkinson's Disease|
182112|NCT01634243|E1|Reported Event|Early-stage Parkinson's Disease|
182113|NCT01634165|B1|Baseline|All Participants|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016, or 0.6 U/kg LY2963016, or 0.3 U/kg Lantus, or 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182114|NCT01634165|P4|Participant Flow|0.6 U/kg Lantus, 0.3 U/kg Lantus, 0.6 U/kg LY, 0.3 U/kg LY|Single subcutaneous dose of 0.6 U/kg Lantus during Period 1; Single subcutaneous dose of 0.3 U/kg Lantus during Period 2; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 3; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 4. There was a minimum washout interval of 6 days between each period.
182115|NCT01634165|P3|Participant Flow|0.3 U/kg Lantus, 0.3 U/kg LY, 0.6 U/kg Lantus, 0.6 U/kg LY|Single subcutaneous dose of 0.3 U/kg Lantus during Period 1; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 2; Single subcutaneous dose of 0.6 U/kg Lantus during Period 3; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 4. There was a minimum washout interval of 6 days between each period.
182116|NCT01634165|P2|Participant Flow|0.6 U/kg LY, 0.6 U/kg Lantus, 0.3 U/kg LY, 0.3 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 1; Single subcutaneous dose of 0.6 U/kg Lantus during Period 2; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 3; Single subcutaneous dose of 0.3 U/kg Lantus during Period 4. There was a minimum washout interval of 6 days between each period.
182117|NCT01634165|P1|Participant Flow|0.3 U/kg LY, 0.6 U/kg LY, 0.3 U/kg Lantus, 0.6 U/kg Lantus|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during Period 1; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 2; Single subcutaneous dose of 0.3 U/kg Lantus during Period 3; Single subcutaneous dose of 0.6 U/kg Lantus during Period 4. There was a minimum washout interval of 6 days between each period.
182118|NCT01634165|O4|Outcome|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182119|NCT01634165|O3|Outcome|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182120|NCT01634165|O2|Outcome|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182121|NCT01634165|O1|Outcome|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182122|NCT01634165|O4|Outcome|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182123|NCT01634165|O3|Outcome|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182124|NCT01634165|O2|Outcome|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182125|NCT01634165|O1|Outcome|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182971|NCT01631071|B3|Baseline|Total|Total of all reporting groups
182126|NCT01634165|O4|Outcome|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182127|NCT01634165|O3|Outcome|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182128|NCT01634165|O2|Outcome|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182129|NCT01634165|O1|Outcome|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182130|NCT01634165|O4|Outcome|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182131|NCT01634165|O3|Outcome|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182132|NCT01634165|O2|Outcome|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182133|NCT01634165|O1|Outcome|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182134|NCT01634165|O4|Outcome|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182135|NCT01634165|O3|Outcome|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182136|NCT01634165|O2|Outcome|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182137|NCT01634165|O1|Outcome|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182138|NCT01634165|O4|Outcome|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182139|NCT01634165|O3|Outcome|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182140|NCT01634165|O2|Outcome|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182141|NCT01634165|O1|Outcome|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182142|NCT01634165|E4|Reported Event|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182143|NCT01634165|E3|Reported Event|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182144|NCT01634165|E2|Reported Event|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182145|NCT01634165|E1|Reported Event|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
182146|NCT01634152|B4|Baseline|Total|Total of all reporting groups
182147|NCT01634152|B3|Baseline|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182148|NCT01634152|B2|Baseline|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182149|NCT01634152|B1|Baseline|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182150|NCT01634152|P3|Participant Flow|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182151|NCT01634152|P2|Participant Flow|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182152|NCT01634152|P1|Participant Flow|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182153|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182154|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182155|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182156|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182157|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182158|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182159|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182160|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182161|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182162|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182163|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182164|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182165|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182166|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182167|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182168|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182169|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182170|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182171|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182172|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182173|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182174|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182175|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182176|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182177|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182178|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182179|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182180|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182181|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182182|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182183|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182184|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182185|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182186|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182187|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182188|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182189|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182190|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182191|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182192|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182379|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
182193|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182194|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182195|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182196|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182197|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182198|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182199|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182200|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182201|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182202|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182203|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182204|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182205|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182206|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182207|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182208|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182209|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182210|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182211|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182212|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182213|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182214|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182215|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182216|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182217|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182218|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182219|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182220|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182221|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182222|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182223|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182224|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182225|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182226|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182227|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182228|NCT01634152|E3|Reported Event|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182229|NCT01634152|E2|Reported Event|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182230|NCT01634152|E1|Reported Event|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182231|NCT01634139|B4|Baseline|Total|Total of all reporting groups
182232|NCT01634139|B3|Baseline|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182233|NCT01634139|B2|Baseline|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182234|NCT01634139|B1|Baseline|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182235|NCT01634139|P3|Participant Flow|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182236|NCT01634139|P2|Participant Flow|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182237|NCT01634139|P1|Participant Flow|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182238|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182239|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182240|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182241|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182242|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182243|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182244|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182245|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182246|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182247|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182248|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182249|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182250|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182251|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182252|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182253|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182254|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182255|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182256|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182257|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182258|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182259|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182260|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182261|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182262|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182263|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182264|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182265|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182266|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182267|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182268|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182269|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182270|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182271|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182272|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182273|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182274|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182275|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182276|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182277|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182278|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182279|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182280|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182281|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182282|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182283|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182284|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182285|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182286|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182287|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182288|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182289|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182290|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182291|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182292|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182293|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182294|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182295|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182296|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182297|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182298|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182299|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182300|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182301|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182302|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182303|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182304|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182305|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182306|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182307|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182308|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182309|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182310|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182311|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182312|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182313|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182314|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182315|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182316|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182317|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182318|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182319|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182320|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182321|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182322|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182323|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182324|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182325|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182326|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182327|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182328|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182329|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182330|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182331|NCT01634139|E3|Reported Event|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182380|NCT01634113|E3|Reported Event|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
182332|NCT01634139|E2|Reported Event|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182333|NCT01634139|E1|Reported Event|Placebo|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
182334|NCT01634113|B4|Baseline|Total|Total of all reporting groups
182335|NCT01634113|B3|Baseline|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
182336|NCT01634113|B2|Baseline|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
182337|NCT01634113|B1|Baseline|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
182338|NCT01634113|P3|Participant Flow|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
182339|NCT01634113|P2|Participant Flow|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
182340|NCT01634113|P1|Participant Flow|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
182341|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
182342|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
182343|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
182344|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
182345|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
182346|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
182347|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
182348|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
182349|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
182350|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
182351|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
182352|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
182353|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
182354|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
182355|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
182356|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
182357|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
182358|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
182359|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
182360|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
182361|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
182362|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
182363|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
182364|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
182365|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
182366|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
182367|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
182368|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
182369|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
182370|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
182371|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
182372|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
182373|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
182374|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
182375|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
182376|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
182377|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
182378|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
182972|NCT01631071|B2|Baseline|Adults From 18 to 60 Years Old Inclusive|
182381|NCT01634113|E2|Reported Event|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
182382|NCT01634113|E1|Reported Event|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
182383|NCT01634100|B1|Baseline|Study Overall|This was a randomised, 3-way crossover trial. 18 patients were randomised to one of six treatment sequences and treated. It was an open label trial in which each treatment period lasted 4 days with a washout period of at least 7 days between each.
182384|NCT01634100|P6|Participant Flow|Empa + Probenecid / Empa + Rifampicin / Empa Alone|"Patients were administered three treatments in the following order:~Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)~Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)~Empa Alone (A single dose of 10mg of empagliflozin (empa))"
182385|NCT01634100|P5|Participant Flow|Empa + Probenecid / Empa Alone / Empa + Rifampicin|"Patients were administered three treatments in the following order:~Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)~Empa Alone (A single dose of 10mg of empagliflozin (empa))~Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)"
182386|NCT01634100|P4|Participant Flow|Empa + Rifampicin / Empa + Probenecid / Empa Alone|"Patients were administered three treatments in the following order:~Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)~Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)~Empa Alone (A single dose of 10mg of empagliflozin (empa))"
182387|NCT01634100|P3|Participant Flow|Empa + Rifampicin / Empa Alone / Empa + Probenecid|"Patients were administered three treatments in the following order:~Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)~Empa Alone (A single dose of 10mg of empagliflozin (empa))~Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)"
182388|NCT01634100|P2|Participant Flow|Empa Alone / Empa + Probenecid / Empa + Rifampicin|"Patients were administered three treatments in the following order:~Empa Alone (A single dose of 10mg of empagliflozin (empa))~Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)~Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)"
182389|NCT01634100|P1|Participant Flow|Empa Alone / Empa + Rifampicin / Empa + Probenecid|"Patients were administered three treatments in the following order:~Empa Alone (A single dose of 10mg of empagliflozin (empa))~Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)~Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)"
182390|NCT01634100|O3|Outcome|Empa + Probenecid|A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3.
182391|NCT01634100|O2|Outcome|Empa + Rifampicin|A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin.
182392|NCT01634100|O1|Outcome|Empa Alone|A single dose of 10mg of empagliflozin (empa).
182393|NCT01634100|O3|Outcome|Empa + Probenecid|A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3.
182394|NCT01634100|O2|Outcome|Empa + Rifampicin|A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin.
182395|NCT01634100|O1|Outcome|Empa Alone|A single dose of 10mg of empagliflozin (empa).
182396|NCT01634100|O3|Outcome|Empa + Probenecid|A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3.
182397|NCT01634100|O2|Outcome|Empa + Rifampicin|A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin.
182398|NCT01634100|O1|Outcome|Empa Alone|A single dose of 10mg of empagliflozin (empa).
182399|NCT01634100|E3|Reported Event|Empa + Probenecid|A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3.
182400|NCT01634100|E2|Reported Event|Empa + Rifampicin|A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin.
182401|NCT01634100|E1|Reported Event|Empa Alone|A single dose of 10mg of empagliflozin (empa).
182402|NCT01633944|B3|Baseline|Total|Total of all reporting groups
182403|NCT01633944|B2|Baseline|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
182404|NCT01633944|B1|Baseline|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
182405|NCT01633944|P3|Participant Flow|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
182406|NCT01633944|P2|Participant Flow|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
182407|NCT01633944|P1|Participant Flow|OL Buprenorphine HCl Buccal Film|Buprenorphine hydrochloride (HCl) buccal film, 75, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration phase
182408|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
182409|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
182410|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
182411|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
182412|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
182413|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
182414|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
182415|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
182416|NCT01633944|O1|Outcome|OL Buprenorphine HCl Buccal Film|Buprenorphine hydrochloride (HCl) buccal film, 75, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration phase
182417|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
182418|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
182419|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
182420|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
182421|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
182422|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
182423|NCT01633944|E3|Reported Event|DB Placebo Film|Placebo buccal film, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
182424|NCT01633944|E2|Reported Event|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
182425|NCT01633944|E1|Reported Event|OL Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 75, 150, 300, or 450 μg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration treatment phase
182426|NCT01633892|B1|Baseline|Fat Grafting|Fat Grafting procedure designed to deliver an autologous fat graft admixed with autologous stromal vascular fraction (SVF) at a high cell dose.
182427|NCT01633892|P1|Participant Flow|Fat Grafting|Fat Grafting procedure designed to deliver an autologous fat graft admixed with autologous stromal vascular fraction (SVF) at a high cell dose.
182428|NCT01633892|O1|Outcome|Fat Grafting|Fat Grafting procedure designed to deliver an autologous fat graft admixed with autologous stromal vascular fraction (SVF) at a high cell dose.
182429|NCT01633892|O1|Outcome|Fat Grafting|Fat Grafting procedure designed to deliver an autologous fat graft admixed with autologous stromal vascular fraction (SVF) at a high cell dose.
182430|NCT01633892|O1|Outcome|Fat Grafting|Fat Grafting procedure designed to deliver an autologous fat graft admixed with autologous stromal vascular fraction (SVF) at a high cell dose.
182431|NCT01633892|O1|Outcome|Fat Grafting|Fat Grafting procedure designed to deliver an autologous fat graft admixed with autologous stromal vascular fraction (SVF) at a high cell dose.
182432|NCT01633892|O1|Outcome|Fat Grafting|Fat Grafting procedure designed to deliver an autologous fat graft admixed with autologous stromal vascular fraction (SVF) at a high cell dose.
182433|NCT01633892|E1|Reported Event|Fat Grafting|"Autologous fat grafting is a potential solution. Grafting of autologous fat tissue is a minimally invasive surgical technique that starts with the harvest of fat tissue from the abdomen or thighs using liposuction through incisions less than 5mm in length. The lipoaspirate is then processed to concentrate the adipose fraction and reinjected into the donor site. This surgical procedure involves the immediate transplantation of a patient’s own tissue in a single operative procedure. It has the advantages of:~Minimal access incisions~Ability to transfer significant amounts of tissue (hundreds of grams of tissue)~Can be used in setting of previous surgical procedures and presence of hardware~Usually performed as outpatient procedure~Minimal donor site morbidity at graft harvest site~Low risk compared with more invasive surgical procedures~Can be repeated multiple times, if necessary, even using the same donor site"
182434|NCT01633853|B3|Baseline|Total|Total of all reporting groups
182435|NCT01633853|B2|Baseline|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
182436|NCT01633853|B1|Baseline|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
182437|NCT01633853|P2|Participant Flow|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
182438|NCT01633853|P1|Participant Flow|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
182439|NCT01633853|O2|Outcome|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
182440|NCT01633853|O1|Outcome|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
182533|NCT01632878|B1|Baseline|Post Myocardial Infarction Omacor Group|Index post Myocardial Infarction patients screened and treated with Omacor as decided by physician
182441|NCT01633853|O2|Outcome|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
182442|NCT01633853|O1|Outcome|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
182443|NCT01633853|O2|Outcome|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
182444|NCT01633853|O1|Outcome|Vitamin D2 Treatment|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
182445|NCT01633853|O2|Outcome|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
182446|NCT01633853|O1|Outcome|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
182447|NCT01633853|O2|Outcome|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
182448|NCT01633853|O1|Outcome|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
182449|NCT01633853|E2|Reported Event|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
182450|NCT01633853|E1|Reported Event|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
182451|NCT01633827|B1|Baseline|Study Group|"This study was a randomized cross-over design so each particiapnt enrolled underweent both placebo and treatment conditions.~During the placebo arm, one participant did not have OSA and another exhibited predominantly central sleep apnea; both were excluded from the analysis. Subject demographics for the 20 remaining unselected patients are shown below."
182452|NCT01633827|P2|Participant Flow|Eszopiclone and Oxygen First, Then Placebo and Air|Subjects will receive both eszopiclone and medical grade oxygen (FIO2 0.4) during two overnight sleep studies, after a washout period of 1 week they will receive placebo and air during two overnight sleep studies
182453|NCT01633827|P1|Participant Flow|Placebo and Air First, Then Eszopiclone and Oxygen|Subjects will receive both a sugar pill and room air during two overnight sleep studies first and subsequently eszopiclone 3 mg with oxygen (FiO2 0.4) after a washout period of 1 week.
182454|NCT01633827|O2|Outcome|Treatment Data|This result reports the AHI under the conditions of oxygen and eszopiclone
182455|NCT01633827|O1|Outcome|Placebo Data|This result reports the AHI under the conditions of room air and a placebo tablet.
182456|NCT01633827|O2|Outcome|Treatment Data|These results represent the ventilation through a active airway (when pharyngeal dilator muscles maximally recruited) at atmospheric pressure during eszopiclone and oxygen administration
182457|NCT01633827|O1|Outcome|Placebo Data|These results represent the ventilation through a active airway (when pharyngeal dilator muscles maximally recruited) at atmospheric pressure during the administration of placebo and room air
182458|NCT01633827|O2|Outcome|Treatment Data|These results represent the ventilation through a passive airway (when pharyngeal dilator muscles are not recruited) at atmospheric pressure and eupneic ventilatory drive during eszopiclone and oxygen administration
182459|NCT01633827|O1|Outcome|Placebo Data|These results represent the ventilation through a passive airway (when pharyngeal dilator muscles are not recruited) at atmospheric pressure and eupneic ventilatory drive during the administration of placebo and room air
182460|NCT01633827|O2|Outcome|Treatment Data|These result report the ventilatory control sensitivity (i.e., loop gain) during eszopiclone and oxygen administration
182461|NCT01633827|O1|Outcome|Placebo Data|These results report the ventilatory control sensitivity (i.e., loop gain) during placebo and room air administration
182462|NCT01633827|O2|Outcome|Treatment Data|These result reports the minimum ventilation that can be tolerated before an arousal from sleep under the conditions of oxygen and a sedative.
182463|NCT01633827|O1|Outcome|Placebo Data|These result reports the minimum ventilation that can be tolerated before an arousal from sleep under placebo and room air administration
182464|NCT01633827|E1|Reported Event|Study Group|This study was a randomized cross-over design so each particiapnt enrolled underweent both placebo and treatment conditions
182465|NCT01633814|B1|Baseline|Transdermal Estradiol or Placebo|"Transdermal estradiol, delivery rate 100 µg day-1 or placebo patch~Transdermal estradiol: transdermal estradiol, delivery rate 100 µg day-1"
182466|NCT01633814|P1|Participant Flow|Transdermal Estradiol or Placebo|"Transdermal estradiol, delivery rate 100 µg day-1 or placebo patch~Transdermal estradiol: transdermal estradiol, delivery rate 100 µg day-1"
182467|NCT01633814|O1|Outcome|Transdermal Estradiol or Placebo|"Transdermal estradiol, delivery rate 100 µg day-1 or placebo patch~Transdermal estradiol: transdermal estradiol, delivery rate 100 µg day-1"
182468|NCT01633814|O1|Outcome|Transdermal Estradiol or Placebo|"Transdermal estradiol, delivery rate 100 µg day-1 or placebo patch~Transdermal estradiol: transdermal estradiol, delivery rate 100 µg day-1"
182582|NCT01632709|O3|Outcome|Neuroma Injection of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
182469|NCT01633814|E1|Reported Event|Transdermal Estradiol or Placebo|"Transdermal estradiol, delivery rate 100 µg day-1 or placebo patch~Transdermal estradiol: transdermal estradiol, delivery rate 100 µg day-1"
182470|NCT01633788|B5|Baseline|Total|Total of all reporting groups
182471|NCT01633788|B4|Baseline|AGN-195263 Vehicle|1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
182472|NCT01633788|B3|Baseline|AGN-195263 0.01%|1 drop of AGN-195263 0.01% instilled in each eye twice daily.
182473|NCT01633788|B2|Baseline|AGN-195263 0.03%|1 drop of AGN-195263 0.03% instilled in each eye twice daily.
182474|NCT01633788|B1|Baseline|AGN-195263 0.1%|1 drop of AGN-195263 0.1% instilled in each eye twice daily.
182475|NCT01633788|P4|Participant Flow|AGN-195263 Vehicle|1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
182476|NCT01633788|P3|Participant Flow|AGN-195263 0.01%|1 drop of AGN-195263 0.01% instilled in each eye twice daily.
182477|NCT01633788|P2|Participant Flow|AGN-195263 0.03%|1 drop of AGN-195263 0.03% instilled in each eye twice daily.
182478|NCT01633788|P1|Participant Flow|AGN-195263 0.1%|1 drop of AGN-195263 0.1% instilled in each eye twice daily.
182479|NCT01633788|O4|Outcome|AGN-195263 Vehicle|1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
182480|NCT01633788|O3|Outcome|AGN-195263 0.01%|1 drop of AGN-195263 0.01% instilled in each eye twice daily.
182481|NCT01633788|O2|Outcome|AGN-195263 0.03%|1 drop of AGN-195263 0.03% instilled in each eye twice daily.
182482|NCT01633788|O1|Outcome|AGN-195263 0.1%|1 drop of AGN-195263 0.1% instilled in each eye twice daily.
182483|NCT01633788|O4|Outcome|AGN-195263 Vehicle|1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
182484|NCT01633788|O3|Outcome|AGN-195263 0.01%|1 drop of AGN-195263 0.01% instilled in each eye twice daily.
182485|NCT01633788|O2|Outcome|AGN-195263 0.03%|1 drop of AGN-195263 0.03% instilled in each eye twice daily.
182486|NCT01633788|O1|Outcome|AGN-195263 0.1%|1 drop of AGN-195263 0.1% instilled in each eye twice daily.
182487|NCT01633788|O4|Outcome|AGN-195263 Vehicle|1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
182488|NCT01633788|O3|Outcome|AGN-195263 0.01%|1 drop of AGN-195263 0.01% instilled in each eye twice daily.
182489|NCT01633788|O2|Outcome|AGN-195263 0.03%|1 drop of AGN-195263 0.03% instilled in each eye twice daily.
182490|NCT01633788|O1|Outcome|AGN-195263 0.1%|1 drop of AGN-195263 0.1% instilled in each eye twice daily.
182491|NCT01633788|E4|Reported Event|AGN-195263 Vehicle|1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
182492|NCT01633788|E3|Reported Event|AGN-195263 0.01%|1 drop of AGN-195263 0.01% instilled in each eye twice daily.
182493|NCT01633788|E2|Reported Event|AGN-195263 0.03%|1 drop of AGN-195263 0.03% instilled in each eye twice daily.
182494|NCT01633788|E1|Reported Event|AGN-195263 0.1%|1 drop of AGN-195263 0.1% instilled in each eye twice daily.
182495|NCT01633320|B3|Baseline|Total|Total of all reporting groups
182496|NCT01633320|B2|Baseline|NRS>3|Patients with numerical rating scale pain score >3 at arrival in PACU
182497|NCT01633320|B1|Baseline|NRS<=3|Patients with numerical rating scale <=3 at arrival in PACU
182498|NCT01633320|P2|Participant Flow|NRS>3 (Moderate to Severe Pain)|Patients with numerical rating scale pain score >3 at arrival in PACU
182499|NCT01633320|P1|Participant Flow|NRS<=3 (no or Mild Pain)|Patients with numerical rating pain scale <=3 at arrival in PACU
182500|NCT01633320|O2|Outcome|NRS>3|Patients with numerical rating scale pain score >3 at arrival in PACU
182501|NCT01633320|O1|Outcome|NRS<=3|Patients with numerical rating scale <=3 at arrival in PACU
182502|NCT01633320|O2|Outcome|NRS>3|Patients with numerical rating scale pain score >3 at arrival in PACU
182503|NCT01633320|O1|Outcome|NRS<=3|Patients with numerical rating scale <=3 at arrival in PACU
182504|NCT01633320|E2|Reported Event|NRS>3|Patients with numerical rating scale pain score >3 at arrival in PACU
182505|NCT01633320|E1|Reported Event|NRS<=3|Patients with numerical rating scale <=3 at arrival in PACU
182506|NCT01632995|B1|Baseline|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.~FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
182507|NCT01632995|P1|Participant Flow|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.~FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
182508|NCT01632995|O1|Outcome|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.~FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
182509|NCT01632995|O1|Outcome|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.~FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
182510|NCT01632995|O1|Outcome|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.~FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
182511|NCT01632995|O1|Outcome|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.~FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
182512|NCT01632995|O1|Outcome|Participants With DBS Testing|All study participants who had at least 1 DBS result
182513|NCT01632995|O1|Outcome|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.~FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
182583|NCT01632709|O2|Outcome|Dry Needling|Placebo: Dry needling
182514|NCT01632995|O1|Outcome|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.~FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
182515|NCT01632995|O1|Outcome|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.~FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
182516|NCT01632995|O1|Outcome|Participants Assessed for Participation|All participants who were assessed for study participation
182517|NCT01632995|O1|Outcome|Participants Assessed for Participation|All participants who were assessed for study participation
182518|NCT01632995|E1|Reported Event|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.~FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
182519|NCT01632904|B3|Baseline|Total|Total of all reporting groups
182520|NCT01632904|B2|Baseline|Hydroxyurea|"Hydroxyurea (HU) (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.~Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently."
182521|NCT01632904|B1|Baseline|Ruxolitinib|"Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.~HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."
182522|NCT01632904|P2|Participant Flow|Hydroxyurea|"Hydroxyurea (HU) (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.~Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently."
182523|NCT01632904|P1|Participant Flow|Ruxolitinib|"Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.~HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."
182524|NCT01632904|O1|Outcome|Ruxolitinib|"Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.~HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."
182525|NCT01632904|O2|Outcome|Hydroxyurea|"Hydroxyurea (HU) (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.~Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently."
182526|NCT01632904|O1|Outcome|Ruxolitinib|"Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.~HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."
182527|NCT01632904|O2|Outcome|Hydroxyurea|"Hydroxyurea (HU) (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.~Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently."
182528|NCT01632904|O1|Outcome|Ruxolitinib|"Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.~HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."
182529|NCT01632904|E2|Reported Event|Hydroxyurea|"Hydroxyurea (HU) (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.~Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently."
182530|NCT01632904|E1|Reported Event|Ruxolitinib|"Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.~HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."
182531|NCT01632878|B3|Baseline|Total|Total of all reporting groups
182532|NCT01632878|B2|Baseline|Post Myocardial Infarction Non-Omacor Group|Index post Myocardial Infarction patients screened and not treated with Omacor as decided by physician
182534|NCT01632878|P1|Participant Flow|Post Myocardial Infarction|One single cohort of Index post Myocardial Infarction patients
182535|NCT01632878|O1|Outcome|Post Myocardial Infarction|Index post Myocardial Infarction patients (Omacor group)
182536|NCT01632878|E1|Reported Event|Post Myocardial Infarction|Index post Myocardial Infarction patients (Omacor group)
182537|NCT01632800|B1|Baseline|Single Arm Study|"Each subjects will undergo escalating exposure to magnetic field~High pulsed magnetic fields: Magnetic fields will escalate in strength"
182538|NCT01632800|P1|Participant Flow|Single Arm Study|"Each subjects will undergo escalating exposure to magnetic field~High pulsed magnetic fields: Magnetic fields will escalate in strength"
182539|NCT01632800|O1|Outcome|Single Arm Study|"Each subjects will undergo escalating exposure to magnetic field~High pulsed magnetic fields: Magnetic fields will escalate in strength"
182540|NCT01632800|E1|Reported Event|Single Arm Study|"Each subjects will undergo escalating exposure to magnetic field~High pulsed magnetic fields: Magnetic fields will escalate in strength"
182541|NCT01632735|B3|Baseline|Total|Total of all reporting groups
182542|NCT01632735|B2|Baseline|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
182543|NCT01632735|B1|Baseline|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education~Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
182544|NCT01632735|P2|Participant Flow|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
182545|NCT01632735|P1|Participant Flow|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education~Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
182546|NCT01632735|O2|Outcome|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
182547|NCT01632735|O1|Outcome|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education~Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
182548|NCT01632735|O2|Outcome|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
182549|NCT01632735|O1|Outcome|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education~Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
182550|NCT01632735|O2|Outcome|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
182551|NCT01632735|O1|Outcome|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education~Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
182552|NCT01632735|O2|Outcome|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
182553|NCT01632735|O1|Outcome|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education~Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
182554|NCT01632735|E2|Reported Event|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
182555|NCT01632735|E1|Reported Event|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education~Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
182556|NCT01632709|B5|Baseline|Total|Total of all reporting groups
182557|NCT01632709|B4|Baseline|Dry Needling at the Neuroma|
182558|NCT01632709|B3|Baseline|Neuroma Injection of Bupivacaine|
182559|NCT01632709|B2|Baseline|Dry Needling at Sympathetic Ganglion|
182560|NCT01632709|B1|Baseline|Sympathetic Nerve Block of Bupivacaine|
182561|NCT01632709|P4|Participant Flow|Dry Needling at the Neuroma|
182562|NCT01632709|P3|Participant Flow|Neuroma Injection of Bupivacaine|
182563|NCT01632709|P2|Participant Flow|Dry Needling at Sympathetic Ganglion|
182564|NCT01632709|P1|Participant Flow|Sympathetic Nerve Block of Bupivacaine|
182565|NCT01632709|O4|Outcome|Dry Needling at the Neuroma|Placebo: Dry needling
182566|NCT01632709|O3|Outcome|Neuroma Injection of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
182567|NCT01632709|O2|Outcome|Dry Needling|Placebo: Dry needling
182568|NCT01632709|O1|Outcome|Sympathetic Nerve Block of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
182569|NCT01632709|O4|Outcome|Dry Needling at the Neuroma|Placebo: Dry needling
182570|NCT01632709|O3|Outcome|Neuroma Injection of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
182571|NCT01632709|O2|Outcome|Dry Needling|Placebo: Dry needling
182572|NCT01632709|O1|Outcome|Sympathetic Nerve Block of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
182573|NCT01632709|O4|Outcome|Dry Needling at the Neuroma|Placebo: Dry needling
182574|NCT01632709|O3|Outcome|Neuroma Injection of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
182575|NCT01632709|O2|Outcome|Dry Needling|Placebo: Dry needling
182576|NCT01632709|O1|Outcome|Sympathetic Nerve Block of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
182577|NCT01632709|O4|Outcome|Dry Needling at the Neuroma|Placebo: Dry needling
182578|NCT01632709|O3|Outcome|Neuroma Injection of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
182579|NCT01632709|O2|Outcome|Dry Needling|Placebo: Dry needling
182580|NCT01632709|O1|Outcome|Sympathetic Nerve Block of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
182581|NCT01632709|O4|Outcome|Dry Needling at the Neuroma|Placebo: Dry needling
182584|NCT01632709|O1|Outcome|Sympathetic Nerve Block of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
182585|NCT01632709|E2|Reported Event|Treatment Group|
182586|NCT01632709|E1|Reported Event|Placebo/Sham Injection|
182587|NCT01632683|B3|Baseline|Total|Total of all reporting groups
182588|NCT01632683|B2|Baseline|Glidescope|"Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation~Glidescope: Glidescope arm"
182589|NCT01632683|B1|Baseline|C-MAC|"Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation~C-MAC: C-MAC arm"
182590|NCT01632683|P2|Participant Flow|Glidescope|"Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation~Glidescope: Glidescope arm"
182591|NCT01632683|P1|Participant Flow|C-MAC|"Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation~C-MAC: C-MAC arm"
182592|NCT01632683|O2|Outcome|Glidescope|"Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation~Glidescope: Glidescope arm"
182593|NCT01632683|O1|Outcome|C-MAC|"Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation~C-MAC: C-MAC arm"
182594|NCT01632683|O2|Outcome|Glidescope|"Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation~Glidescope: Glidescope arm"
182595|NCT01632683|O1|Outcome|C-MAC|"Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation~C-MAC: C-MAC arm"
182596|NCT01632683|O2|Outcome|Glidescope|"Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation~Glidescope: Glidescope arm"
182597|NCT01632683|O1|Outcome|C-MAC|"Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation~C-MAC: C-MAC arm"
182598|NCT01632683|O2|Outcome|Glidescope|"Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation~Glidescope: Glidescope arm"
182599|NCT01632683|O1|Outcome|C-MAC|"Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation~C-MAC: C-MAC arm"
182600|NCT01632683|O2|Outcome|Glidescope|"Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation~Glidescope: Glidescope arm"
182601|NCT01632683|O1|Outcome|C-MAC|"Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation~C-MAC: C-MAC arm"
182602|NCT01632683|E2|Reported Event|Glidescope|"Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation~Glidescope: Glidescope arm"
182603|NCT01632683|E1|Reported Event|C-MAC|"Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation~C-MAC: C-MAC arm"
182604|NCT01632423|B1|Baseline|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
182605|NCT01632423|P1|Participant Flow|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
182606|NCT01632423|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
182607|NCT01632423|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
182608|NCT01632423|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
182609|NCT01632423|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
182610|NCT01632423|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
182611|NCT01632423|E1|Reported Event|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
182612|NCT01632345|B6|Baseline|Total|Total of all reporting groups
182613|NCT01632345|B5|Baseline|Efavirenz 600 mg: Part I/II Combined|Efavirenz 600 mg once daily plus TRUVADA once daily
182614|NCT01632345|B4|Baseline|Doravirine 200 mg: Part I/II Combined|Doravirine 200 mg once daily plus TRUVADA once daily
182615|NCT01632345|B3|Baseline|Doravirine 100 mg: Part I/II Combined|Doravirine 100 mg once daily plus TRUVADA once daily
182616|NCT01632345|B2|Baseline|Doravirine 50 mg Part I/II Combined|Doravirine 50 mg once daily plus TRUVADA once daily
182617|NCT01632345|B1|Baseline|Doravirine 25 mg: Part I/II Combined|Doravirine 25 mg once daily plus TRUVADA once daily
182618|NCT01632345|P7|Participant Flow|Part II: Efavirenz 600 mg|Efavirenz 600 mg once daily plus TRUVADA once daily in Part II
182619|NCT01632345|P6|Participant Flow|Part II: Doravirine 100 mg|Doravirine 100 mg once daily plus TRUVADA once daily in Part II
182620|NCT01632345|P5|Participant Flow|Part I: Efavirenz 600 mg|Efavirenz 600 mg once daily plus TRUVADA once daily in Part I
182621|NCT01632345|P4|Participant Flow|Part I: Doravirine 200 mg|Doravirine 200 mg once daily plus TRUVADA once daily in Part I
182622|NCT01632345|P3|Participant Flow|Part I: Doravirine 100 mg|Doravirine 100 mg once daily plus TRUVADA once daily in Part I
182623|NCT01632345|P2|Participant Flow|Part I: Doravirine 50 mg|Doravirine 50 mg once daily plus TRUVADA once daily in Part I
182624|NCT01632345|P1|Participant Flow|Part I: Doravirine 25 mg|Doravirine 25 mg once daily plus TRUVADA once daily in Part I
182625|NCT01632345|O2|Outcome|Efavirenz 600 mg: Part I/II (Combined)|Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
182626|NCT01632345|O1|Outcome|Doravirine 100 mg: Part I/II (Combined)|Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
182627|NCT01632345|O2|Outcome|Efavirenz 600 mg: Part I/II (Combined)|Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
182628|NCT01632345|O1|Outcome|Doravirine 100 mg: Part I/II (Combined)|Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
182629|NCT01632345|O2|Outcome|Efavirenz 600 mg: Part I/II (Combined)|Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
182630|NCT01632345|O1|Outcome|Doravirine 100 mg: Part I/II (Combined)|Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
182631|NCT01632345|O2|Outcome|Efavirenz 600 mg: Part I/II (Combined)|Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
182632|NCT01632345|O1|Outcome|Doravirine 100 mg: Part I/II (Combined)|Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
182633|NCT01632345|O2|Outcome|Efavirenz 600 mg: Part I/II (Combined)|Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
182634|NCT01632345|O1|Outcome|Doravirine 100 mg: Part I/II (Combined)|Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
182635|NCT01632345|O5|Outcome|Efavirenz 600 mg: Part I|Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
182636|NCT01632345|O4|Outcome|Doravirine 200 mg: Part I|Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
182637|NCT01632345|O3|Outcome|Doravirine 100 mg: Part I|Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
182638|NCT01632345|O2|Outcome|Doravirine 50 mg: Part I|Doravirine 50 mg once daily plus TRUVADA once daily received in Part I
182639|NCT01632345|O1|Outcome|Doravirine 25 mg: Part I|Doravirine 25 mg once daily plus TRUVADA once daily received in Part I
182640|NCT01632345|O2|Outcome|Efavirenz 600 mg: Part I/II (Combined)|Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
182641|NCT01632345|O1|Outcome|Doravirine 100 mg: Part I/II (Combined)|Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
182642|NCT01632345|O2|Outcome|Efavirenz 600 mg: Part I/II (Combined)|Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
182643|NCT01632345|O1|Outcome|Doravirine 100 mg: Part I/II (Combined)|Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
182644|NCT01632345|O2|Outcome|Efavirenz 600 mg: Part I/II (Combined)|Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
182645|NCT01632345|O1|Outcome|Doravirine 100 mg: Part I/II (Combined)|Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
182646|NCT01632345|O5|Outcome|Efavirenz 600 mg: Part I|Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
182647|NCT01632345|O4|Outcome|Doravirine 200 mg: Part I|Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
182648|NCT01632345|O3|Outcome|Doravirine 100 mg: Part I|Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
182649|NCT01632345|O2|Outcome|Doravirine 50 mg: Part I|Doravirine 50 mg once daily plus TRUVADA once daily received in Part I
182650|NCT01632345|O1|Outcome|Doravirine 25 mg: Part I|Doravirine 25 mg once daily plus TRUVADA once daily received in Part I
182651|NCT01632345|O2|Outcome|Efavirenz 600 mg: Part I/II (Combined)|Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
182652|NCT01632345|O1|Outcome|Doravirine 100 mg: Part I/II (Combined)|Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
182653|NCT01632345|O2|Outcome|Efavirenz 600 mg: Part I/II (Combined)|Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
182654|NCT01632345|O1|Outcome|Doravirine 100 mg: Part I/II (Combined)|Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
182655|NCT01632345|O2|Outcome|Efavirenz 600 mg: Part I/II (Combined)|Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
182656|NCT01632345|O1|Outcome|Doravirine 100 mg: Part I/II (Combined)|Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
182657|NCT01632345|O5|Outcome|Efavirenz 600 mg: Part I|Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
182658|NCT01632345|O4|Outcome|Doravirine 200 mg: Part I|Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
182659|NCT01632345|O3|Outcome|Doravirine 100 mg: Part I|Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
182660|NCT01632345|O2|Outcome|Doravirine 50 mg: Part I|Doravirine 50 mg once daily plus TRUVADA once daily received in Part I
182661|NCT01632345|O1|Outcome|Doravirine 25 mg: Part I|Doravirine 25 mg once daily plus TRUVADA once daily received in Part I
182662|NCT01632345|O2|Outcome|Efavirenz 600 mg: Part I/II (Combined)|Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
182663|NCT01632345|O1|Outcome|Doravirine 100 mg: Part I/II (Combined)|Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
182664|NCT01632345|O2|Outcome|Efavirenz 600 mg: Part I/II (Combined)|Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
182665|NCT01632345|O1|Outcome|Doravirine 100 mg: Part I/II (Combined)|Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
182666|NCT01632345|O2|Outcome|Efavirenz 600 mg: Part I/II (Combined)|Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
182667|NCT01632345|O1|Outcome|Doravirine 100 mg: Part I/II (Combined)|Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
182668|NCT01632345|O5|Outcome|Efavirenz 600 mg: Part I|Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
182669|NCT01632345|O4|Outcome|Doravirine 200 mg: Part I|Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
182670|NCT01632345|O3|Outcome|Doravirine 100 mg: Part I|Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
182671|NCT01632345|O2|Outcome|Doravirine 50 mg: Part I|Doravirine 50 mg once daily plus TRUVADA once daily received in Part I
182672|NCT01632345|O1|Outcome|Doravirine 25 mg: Part I|Doravirine 25 mg once daily plus TRUVADA once daily received in Part I
182673|NCT01632345|O5|Outcome|Efavirenz 600 mg: Part I|Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
182674|NCT01632345|O4|Outcome|Doravirine 200 mg: Part I|Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
182675|NCT01632345|O3|Outcome|Doravirine 100 mg : Part I|Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
182676|NCT01632345|O2|Outcome|Doravirine 50 mg: Part I|Doravirine 50 mg once daily plus TRUVADA once daily received in Part I
182973|NCT01631071|B1|Baseline|Elderly Subjects Aged Over 60 Years|
182677|NCT01632345|O1|Outcome|Doravirine 25 mg: Part I|Doravirine 25 mg once daily plus TRUVADA once daily received in Part I
182678|NCT01632345|E5|Reported Event|Efavirenz 600 mg: Part I (n=108)|Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I & Part II (Combined)
182679|NCT01632345|E4|Reported Event|Doravirine 200 mg (n=41)|Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
182680|NCT01632345|E3|Reported Event|Doravirine 100 mg (n=108)|Doravirine 100 mg once daily plus TRUVADA once daily received in Part I & Part II (Combined)
182681|NCT01632345|E2|Reported Event|Doravirine 50 mg (n=43)|Doravirine 50 mg once daily plus TRUVADA once daily received in Part I
182682|NCT01632345|E1|Reported Event|Doravirine 25 mg (n=40)|Doravirine 25 mg once daily plus TRUVADA once daily received in Part I
182683|NCT01632280|B3|Baseline|Total|Total of all reporting groups
182684|NCT01632280|B2|Baseline|Sham tDCS|In this arm, participants received 10 daily sessions of sham Transcranial Direct Current Sitmulation with the same duration and electrode montage as in the real tDCS arm (20 minutes, targeting the right inferior frontal gyrus). In this case, current was applied for 30 s only according to standard procedures, and participants performed a control task during which they observed and provided responses for the same food and non-food pictures as in the active group task, but without the requirement of inhibitory control for performance.
182685|NCT01632280|B1|Baseline|Active tDCS|In this arm, participants received 10 daily sessions of active Transcranial Direct Current Stimulation (2mA, 20 min per session) over the course of two weeks. The anode electrode was placed over the right inferior frontal gyrus, defined as F8 (10-20 EEG system), with the cathode electrode placed over the contralateral supraorbital area, above the left eyebrow. During each session participants performed a computerized task designed to engage the inhibitory control circuit when confronted with food stimuli.
182686|NCT01632280|P2|Participant Flow|Sham tDCS|In this arm, participants received 10 daily sessions of sham Transcranial Direct Current Sitmulation with the same duration and electrode montage as in the real tDCS arm (20 minutes, targeting the right inferior frontal gyrus). In this case, current was applied for 30 s only according to standard procedures, and participants performed a control task during which they observed and provided responses for the same food and non-food pictures as in the active group task, but without the requirement of inhibitory control for performance.
182687|NCT01632280|P1|Participant Flow|Active tDCS|In this arm, participants received 10 daily sessions of active Transcranial Direct Current Stimulation (2mA, 20 min per session) over the course of two weeks. The anode electrode was placed over the right inferior frontal gyrus, defined as F8 (10-20 EEG system), with the cathode electrode placed over the contralateral supraorbital area, above the left eyebrow. During each session participants performed a computerized task designed to engage the inhibitory control circuit when confronted with food stimuli.
182688|NCT01632280|O2|Outcome|Sham tDCS|In this arm, participants received 10 daily sessions of sham Transcranial Direct Current Sitmulation with the same duration and electrode montage as in the real tDCS arm (20 minutes, targeting the right inferior frontal gyrus). In this case, current was applied for 30 s only according to standard procedures, and participants performed a control task during which they observed and provided responses for the same food and non-food pictures as in the active group task, but without the requirement of inhibitory control for performance.
182689|NCT01632280|O1|Outcome|Active tDCS|In this arm, participants received 10 daily sessions of active Transcranial Direct Current Stimulation (2mA, 20 min per session) over the course of two weeks. The anode electrode was placed over the right inferior frontal gyrus, defined as F8 (10-20 EEG system), with the cathode electrode placed over the contralateral supraorbital area, above the left eyebrow. During each session participants performed a computerized task designed to engage the inhibitory control circuit when confronted with food stimuli.
182690|NCT01632280|O2|Outcome|Sham tDCS|In this arm, participants received 10 daily sessions of sham Transcranial Direct Current Sitmulation with the same duration and electrode montage as in the real tDCS arm (20 minutes, targeting the right inferior frontal gyrus). In this case, current was applied for 30 s only according to standard procedures, and participants performed a control task during which they observed and provided responses for the same food and non-food pictures as in the active group task, but without the requirement of inhibitory control for performance.
182691|NCT01632280|O1|Outcome|Active tDCS|In this arm, participants received 10 daily sessions of active Transcranial Direct Current Stimulation (2mA, 20 min per session) over the course of two weeks. The anode electrode was placed over the right inferior frontal gyrus, defined as F8 (10-20 EEG system), with the cathode electrode placed over the contralateral supraorbital area, above the left eyebrow. During each session participants performed a computerized task designed to engage the inhibitory control circuit when confronted with food stimuli.
182692|NCT01632280|O2|Outcome|Sham tDCS|In this arm, participants received 10 daily sessions of sham Transcranial Direct Current Sitmulation with the same duration and electrode montage as in the real tDCS arm (20 minutes, targeting the right inferior frontal gyrus). In this case, current was applied for 30 s only according to standard procedures, and participants performed a control task during which they observed and provided responses for the same food and non-food pictures as in the active group task, but without the requirement of inhibitory control for performance.
182693|NCT01632280|O1|Outcome|Active tDCS|In this arm, participants received 10 daily sessions of active Transcranial Direct Current Stimulation (2mA, 20 min per session) over the course of two weeks. The anode electrode was placed over the right inferior frontal gyrus, defined as F8 (10-20 EEG system), with the cathode electrode placed over the contralateral supraorbital area, above the left eyebrow. During each session participants performed a computerized task designed to engage the inhibitory control circuit when confronted with food stimuli.
182694|NCT01632280|E2|Reported Event|Sham tDCS|In this arm, participants received 10 daily sessions of sham Transcranial Direct Current Sitmulation with the same duration and electrode montage as in the real tDCS arm (20 minutes, targeting the right inferior frontal gyrus). In this case, current was applied for 30 s only according to standard procedures, and participants performed a control task during which they observed and provided responses for the same food and non-food pictures as in the active group task, but without the requirement of inhibitory control for performance.
182717|NCT01632020|B2|Baseline|Metformin|Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
182718|NCT01632020|B1|Baseline|Placebo|Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
194295|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
182695|NCT01632280|E1|Reported Event|Active tDCS|In this arm, participants received 10 daily sessions of active Transcranial Direct Current Stimulation (2mA, 20 min per session) over the course of two weeks. The anode electrode was placed over the right inferior frontal gyrus, defined as F8 (10-20 EEG system), with the cathode electrode placed over the contralateral supraorbital area, above the left eyebrow. During each session participants performed a computerized task designed to engage the inhibitory control circuit when confronted with food stimuli.
182696|NCT01632267|B1|Baseline|Depression and Anxiety|Subjects with a primary diagnosis of depression or anxiety disorder.
182697|NCT01632267|P1|Participant Flow|Depression and Anxiety|Subjects with a primary diagnosis of depression or anxiety disorder.
182698|NCT01632267|O1|Outcome|Depression and Anxiety|Subjects with a primary diagnosis of depression or anxiety disorder.
182699|NCT01632267|E1|Reported Event|Depression and Anxiety|Subjects with a primary diagnosis of depression or anxiety disorder.
182700|NCT01632215|B3|Baseline|Total|Total of all reporting groups
182701|NCT01632215|B2|Baseline|Sugar Pill|"Placebo group~Sugar pill: Sugar pill 01 dose"
182702|NCT01632215|B1|Baseline|Preoperative Gabapentine,|"Gabapentine~Gabapentine: Gabapentine 600 mg 01 dose"
182703|NCT01632215|P2|Participant Flow|Sugar Pill|"Placebo group~Sugar pill: Sugar pill 01 dose"
182704|NCT01632215|P1|Participant Flow|Preoperative Gabapentine,|"Gabapentine~Gabapentine: Gabapentine 600 mg 01 dose"
182705|NCT01632215|O2|Outcome|Sugar Pill|"Placebo group~Sugar pill: Sugar pill 01 dose"
182706|NCT01632215|O1|Outcome|Preoperative Gabapentine,|"Gabapentine~Gabapentine: Gabapentine 600 mg 01 dose"
182707|NCT01632215|E2|Reported Event|Sugar Pill|"Placebo group~Sugar pill: Sugar pill 01 dose"
182708|NCT01632215|E1|Reported Event|Preoperative Gabapentine,|"Gabapentine~Gabapentine: Gabapentine 600 mg 01 dose"
182709|NCT01632150|B1|Baseline|Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks and beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles and beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion. Those patients with suboptimal response, defined as evidence of progressive disease between end of Cycle 2 and end of Cycle 4 or inability to achieve partial response or better by end of Cycle 4, also received cyclophosphamide, 50 mg. Cyclophosphamide could not be added beyond Cycle 5.
182710|NCT01632150|P1|Participant Flow|Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks and beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles and beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion. Those patients with suboptimal response, defined as evidence of progressive disease between end of Cycle 2 and end of Cycle 4 or inability to achieve partial response or better by end of Cycle 4, also received cyclophosphamide, 50 mg. Cyclophosphamide could not be added beyond Cycle 5.
182711|NCT01632150|O1|Outcome|Thalidomide + Elotuzumab + Dexamethasone|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks, then beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles, then beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion.
182712|NCT01632150|O1|Outcome|Thalidomide + Elotuzumab + Dexamethasone|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks and beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles, then beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion.
182713|NCT01632150|O1|Outcome|Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks, then beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles, then beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion. Those patients with suboptimal response, defined as evidence of progressive disease between end of Cycle 2 and end of Cycle 4 or inability to achieve partial response or better by end of Cycle 4, also received cyclophosphamide, 50 mg. Cyclophosphamide could not be added beyond Cycle 5.
182714|NCT01632150|O1|Outcome|Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks and beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles and beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion. Those patients with suboptimal response, defined as evidence of progressive disease between end of Cycle 2 and end of Cycle 4 or inability to achieve partial response or better by end of Cycle 4, also received cyclophosphamide, 50 mg. Cyclophosphamide could not be added beyond Cycle 5.
182715|NCT01632150|E1|Reported Event|All Treated Subjects|
182716|NCT01632020|B3|Baseline|Total|Total of all reporting groups
182719|NCT01632020|P2|Participant Flow|Metformin|Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
182720|NCT01632020|P1|Participant Flow|Placebo|Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
182721|NCT01632020|O2|Outcome|Metformin|Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
182722|NCT01632020|O1|Outcome|Placebo|Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
182723|NCT01632020|O2|Outcome|Metformin|Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
182724|NCT01632020|O1|Outcome|Placebo|Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
182725|NCT01632020|E2|Reported Event|Metformin|Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
182726|NCT01632020|E1|Reported Event|Placebo|Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
182727|NCT01631929|B3|Baseline|Total|Total of all reporting groups
182728|NCT01631929|B2|Baseline|Two Bags|"Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.~Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line."
182729|NCT01631929|B1|Baseline|One Bag|"IV infusion of fluids, electrolytes and dextrose using one bag~One bag: Infusion of dextrose and electrolytes using one bag"
182730|NCT01631929|P2|Participant Flow|Two Bags|"Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.~Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line."
182731|NCT01631929|P1|Participant Flow|One Bag|"IV infusion of fluids, electrolytes and dextrose using one bag~One bag: Infusion of dextrose and electrolytes using one bag"
182732|NCT01631929|O2|Outcome|Two Bags|"Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.~Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line."
182733|NCT01631929|O1|Outcome|One Bag|"IV infusion of fluids, electrolytes and dextrose using one bag~One bag: Infusion of dextrose and electrolytes using one bag"
182734|NCT01631929|E2|Reported Event|Two Bags|"Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.~Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line."
182735|NCT01631929|E1|Reported Event|One Bag|"IV infusion of fluids, electrolytes and dextrose using one bag~One bag: Infusion of dextrose and electrolytes using one bag"
182736|NCT01631864|B3|Baseline|Total|Total of all reporting groups
182737|NCT01631864|B2|Baseline|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
182738|NCT01631864|B1|Baseline|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
182739|NCT01631864|P2|Participant Flow|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
182740|NCT01631864|P1|Participant Flow|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
182741|NCT01631864|O2|Outcome|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
182742|NCT01631864|O1|Outcome|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
182743|NCT01631864|O2|Outcome|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
182744|NCT01631864|O1|Outcome|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
182745|NCT01631864|O2|Outcome|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
182746|NCT01631864|O1|Outcome|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
182747|NCT01631864|O2|Outcome|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
182748|NCT01631864|O1|Outcome|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
182749|NCT01631864|E2|Reported Event|Amlodipine|Amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
182750|NCT01631864|E1|Reported Event|LCZ696|LCZ696 400 mg plus placebo to Amlodipine once daily for 8 weeks
182751|NCT01631825|B1|Baseline|SPM 962|SPM 962 transdermal patch
182752|NCT01631825|P1|Participant Flow|SPM 962|SPM 962 transdermal patch
182753|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
182754|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
182755|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
182756|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
182757|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
182758|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
182759|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
182760|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
182761|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
182762|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
182763|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
182764|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
182765|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
182766|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
182767|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
182768|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
182771|NCT01631812|B1|Baseline|SPM 962|SPM 962 : SPM 962 transdermal patch once a daily up to 36.0 mg/day
182772|NCT01631812|P1|Participant Flow|SPM 962|SPM 962 : SPM 962 transdermal patch once a daily up to 36.0 mg/day
182773|NCT01631812|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
182774|NCT01631812|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
182775|NCT01631812|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
182776|NCT01631812|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
182777|NCT01631812|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
182778|NCT01631812|E1|Reported Event|SPM 962|SPM 962 : SPM 962 transdermal patch once a daily up to 36.0 mg/day
182779|NCT01631682|B5|Baseline|Total|Total of all reporting groups
182780|NCT01631682|B4|Baseline|Intranasal Oxytocin|"A single 32IU dose of Syntocinon (intranasal oxytocin) is given to begin visit 2, followed by a 10 minute wait and subsequent CS reactivation.~Intranasal oxytocin: 32 IU, 8 self-administered intranasal sprays, 4 in each nostril"
182781|NCT01631682|B3|Baseline|Mifepristone|"a single dose of 1800mg (200mg tablets) mifepristone may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation~Mifepristone: 1800mg, 9 tablets"
182782|NCT01631682|B2|Baseline|Reactivation With Time Delay|"For those not receiving propranolol on visit 2, one experimental CS will be reactivated, followed by a 10 minute break and subsequently extinction~Reactivation: subject is re-exposed to CS+R on day 2 (code for CS that is both paired with shock and reactivated on day 2)"
182783|NCT01631682|B1|Baseline|Propranolol|"a single dose of 40mg propranolol may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation~Propranolol: 40mg single pill"
182784|NCT01631682|P4|Participant Flow|Intranasal Oxytocin|"A single 32IU dose of Syntocinon (intranasal oxytocin) is given to begin visit 2, followed by a 10 minute wait and subsequent CS reactivation.~Intranasal oxytocin: 32 IU, 8 self-administered intranasal sprays, 4 in each nostril"
182785|NCT01631682|P3|Participant Flow|Mifepristone|"a single dose of 1800mg (200mg tablets) mifepristone may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation~Mifepristone: 1800mg, 9 tablets"
182786|NCT01631682|P2|Participant Flow|Reactivation With Time Delay|"For those not receiving propranolol on visit 2, one experimental CS will be reactivated, followed by a 10-min break and then extinction.~Subject is re-exposed to CS+R on day 2 (code for CS that is both paired with shock and reactivated on day 2)"
182787|NCT01631682|P1|Participant Flow|Propranolol|"a single dose of 40mg propranolol may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation~Propranolol: 40mg single pill"
182788|NCT01631682|O4|Outcome|Intranasal Oxytocin|"A single 32IU dose of Syntocinon (intranasal oxytocin) is given to begin visit 2, followed by a 10 minute wait and subsequent CS reactivation.~Intranasal oxytocin: 32 IU, 8 self-administered intranasal sprays, 4 in each nostril"
182789|NCT01631682|O3|Outcome|Mifepristone|"a single dose of 1800mg (200mg tablets) mifepristone may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation~Mifepristone: 1800mg, 9 tablets"
182790|NCT01631682|O2|Outcome|Reactivation With Time Delay|"For those not receiving propranolol on visit 2, one experimental CS will be reactivated, followed by a 10-min break and then extinction.~Subject is re-exposed to CS+R on day 2 (code for CS that is both paired with shock and reactivated on day 2)"
182791|NCT01631682|O1|Outcome|Propranolol|"a single dose of 40mg propranolol may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation~Propranolol: 40mg single pill"
182792|NCT01631682|E4|Reported Event|Intranasal Oxytocin|"A single 32IU dose of Syntocinon (intranasal oxytocin) is given to begin visit 2, followed by a 10 minute wait and subsequent CS reactivation.~Intranasal oxytocin: 32 IU, 8 self-administered intranasal sprays, 4 in each nostril"
182793|NCT01631682|E3|Reported Event|Mifepristone|"a single dose of 1800mg (200mg tablets) mifepristone may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation~Mifepristone: 1800mg, 9 tablets"
182794|NCT01631682|E2|Reported Event|Reactivation With Time Delay|"For those not receiving propranolol on visit 2, one experimental CS will be reactivated, followed by a 10-min break and then extinction.~Subject is re-exposed to CS+R on day 2 (code for CS that is both paired with shock and reactivated on day 2)"
182795|NCT01631682|E1|Reported Event|Propranolol|"a single dose of 40mg propranolol may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation~Propranolol: 40mg single pill"
182796|NCT01631656|B3|Baseline|Total|Total of all reporting groups
182797|NCT01631656|B2|Baseline|Azelaic Acid Right Side Plus Laser|"Azelaic acid 15% twice daily for 6 weeks to the right side of the face, plus laser treatment with Nd:Yag laser once at 2 weeks.~Azelaic acid: 15% gel, twice daily, 6 weeks~Nd:Yag laser: Treatment with Nd:Yag laser to all the face, once at Week 2."
182798|NCT01631656|B1|Baseline|Azelaic Acid Left Side Plus Laser|"Azelaic acid 15% twice daily for 6 weeks to the left side of the face, plus laser treatment with Nd:Yag laser once at 2 weeks.~Azelaic acid: 15% gel, twice daily, 6 weeks~Nd:Yag laser: Treatment with Nd:Yag laser to all the face, once at Week 2."
182799|NCT01631656|P2|Participant Flow|Azelaic Acid Right Side Plus Laser|"Azelaic acid 15% twice daily for 6 weeks to the right side of the face, plus laser treatment with Nd:Yag laser once at 2 weeks.~Azelaic acid: 15% gel, twice daily, 6 weeks~Nd:Yag laser: Treatment with Nd:Yag laser to all the face, once at Week 2."
182800|NCT01631656|P1|Participant Flow|Azelaic Acid Left Side Plus Laser|"Azelaic acid 15% twice daily for 6 weeks to the left side of the face, plus laser treatment with Nd:Yag laser once at 2 weeks.~Azelaic acid: 15% gel, twice daily, 6 weeks~Nd:Yag laser: Treatment with Nd:Yag laser to all the face, once at Week 2."
182801|NCT01631656|O2|Outcome|LASER ONLY|Laser treatment with no azelaic acid on one side of face
182802|NCT01631656|O1|Outcome|Azelaic Acid Plus Laser|"Azelaic acid 15% twice daily for 6 weeks, plus laser treatment with Nd:Yag laser once at 2 weeks.~Azelaic acid: 15% gel, twice daily, 6 weeks~Nd:Yag laser: Treatment with Nd:Yag laser of half the face, once at Week 2."
182803|NCT01631656|E2|Reported Event|Laser Only|Laser treatment with no azelaic acid on one side of face
182804|NCT01631656|E1|Reported Event|Azelaic Acid Plus Laser|Azelaic acid 15% twice daily for 6 weeks on one side of the face, plus laser treatment with Nd:Yag laser once at 2 weeks.
182805|NCT01631630|B3|Baseline|Total|Total of all reporting groups
182806|NCT01631630|B2|Baseline|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182807|NCT01631630|B1|Baseline|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182808|NCT01631630|P2|Participant Flow|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182809|NCT01631630|P1|Participant Flow|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182810|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182811|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182812|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182813|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182814|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182815|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182816|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182817|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182818|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182819|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182820|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182821|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182822|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182823|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182824|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182825|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182826|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182827|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182828|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182829|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182830|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182831|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182832|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182833|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182834|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182835|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182836|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182837|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182838|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182839|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182840|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182841|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182842|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182843|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182844|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182845|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182846|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182847|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182848|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182849|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182850|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182851|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182852|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182853|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182854|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182855|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182856|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182857|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182858|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182859|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182860|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182861|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182862|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182863|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182864|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182865|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182866|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182867|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182868|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182869|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182870|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182871|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182872|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182873|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182874|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182875|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182876|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182877|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182878|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182879|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182880|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182881|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182882|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182883|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182884|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182885|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182886|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182887|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182888|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182889|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182890|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182891|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182892|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182893|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182894|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182895|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182896|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182897|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182898|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182899|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182900|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182901|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182902|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182903|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182904|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182905|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182906|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182907|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182908|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182909|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182910|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182911|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182912|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182913|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182914|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182915|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182916|NCT01631630|E2|Reported Event|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
182917|NCT01631630|E1|Reported Event|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
182918|NCT01631435|B1|Baseline|Bowel Prep Regimen|"Each study subject will undergo a bowel preparation followed by a PillCam procedure.~Pillcam colon capsule and PillCam™ Prep Procedure: PillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day.~Ileocolonoscopy: Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure~• Ileocolonoscopy with intubation of terminal ileum"
182919|NCT01631435|P1|Participant Flow|Bowel Prep Regimen|"Each study subject will undergo a bowel preparation followed by a PillCam procedure.~Pillcam colon capsule and PillCam™ Prep Procedure: PillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day.~Ileocolonoscopy: Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure~• Ileocolonoscopy with intubation of terminal ileum"
182920|NCT01631435|O2|Outcome|# Casesclassified as “Active CD is Likely” by IC|"The number of subjects having active Crohn's disease(CD) in their TI and / or colon as detected by the PillCam Platform with the Ileo colonoscopy (IC) procedure.~“Active Crohn’s disease” included the followings lesions:~Aphthous ulceration~Ulcers (other than Aphthous)~Bleeding~Inflammatory stricture Lesions other than the above list were classified as “Non active Crohn’s disease.”"
182921|NCT01631435|O1|Outcome|# Casesclassified as “Active CD is Likely” by CE|"The number of subjects having active Crohn's disease(CD) in their TI and / or colon as detected by the PillCam Platform with the CD capsule endoscopy(CE).~“Active Crohn’s disease” included the followings lesions:~Aphthous ulceration~Ulcers (other than Aphthous)~Bleeding~Inflammatory stricture Lesions other than the above list were classified as “Non active Crohn’s disease.”"
182922|NCT01631435|E1|Reported Event|Bowel Prep Regimen|"Each study subject will undergo a bowel preparation followed by a PillCam procedure.~Pillcam colon capsule and PillCam™ Prep Procedure: PillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day.~Ileocolonoscopy: Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure~• Ileocolonoscopy with intubation of terminal ileum"
182923|NCT01631331|B1|Baseline|Treatment (Vismodegib and Mohs Surgery)|"Patients receive vismodegib PO daily for 3-6 months based on the size of basal cell carcinoma and then undergo Mohs surgery.~vismodegib: Given PO~Mohs surgery: Undergo Mohs surgery"
182924|NCT01631331|P1|Participant Flow|Treatment (Vismodegib and Mohs Surgery)|"Patients receive vismodegib PO daily for 3-6 months based on the size of basal cell carcinoma and then undergo Mohs surgery.~vismodegib: Given PO~Mohs surgery: Undergo Mohs surgery"
182925|NCT01631331|O1|Outcome|Treatment (Vismodegib and Mohs Surgery)|"Patients receive vismodegib PO daily for 3-6 months based on the size of basal cell carcinoma.~vismodegib: Given PO~Mohs surgery: Undergo Mohs surgery"
182926|NCT01631331|O1|Outcome|Treatment (Vismodegib and Mohs Surgery)|"Patients receive vismodegib PO daily for 3-6 months based on the size of basal cell carcinoma and then undergo Mohs surgery.~vismodegib: Given PO~Mohs surgery: Undergo Mohs surgery"
182927|NCT01631331|O1|Outcome|Treatment (Vismodegib and Mohs Surgery)|"Patients receive vismodegib PO daily for 3-6 months based on the size of basal cell carcinoma and then undergo Mohs surgery.~vismodegib: Given PO~Mohs surgery: Undergo Mohs surgery"
182928|NCT01631331|O1|Outcome|Treatment (Vismodegib and Mohs Surgery)|"Patients receive vismodegib PO daily for 3-6 months based on the size of basal cell carcinoma and then undergo Mohs surgery.~vismodegib: Given PO~Mohs surgery: Undergo Mohs surgery"
182929|NCT01631331|E1|Reported Event|Treatment (Vismodegib and Mohs Surgery)|"Patients receive vismodegib PO daily for 3-6 months based on the size of basal cell carcinoma and then undergo Mohs surgery.~vismodegib: Given PO~Mohs surgery: Undergo Mohs surgery"
182930|NCT01631227|B3|Baseline|Total|Total of all reporting groups
182931|NCT01631227|B2|Baseline|Eprosartan Mesylate|Eprosartan Mesylate 600 mg + Placebo Eprosartan
182932|NCT01631227|B1|Baseline|Eprosartan|Eprosartan 450 mg + Placebo Eprosartan Mesylate
182933|NCT01631227|P2|Participant Flow|Eprosartan Mesylate|Eprosartan Mesylate 600 mg + Placebo Eprosartan
182934|NCT01631227|P1|Participant Flow|Eprosartan|Eprosartan 450 mg + Placebo Eprosartan Mesylate
182935|NCT01631227|O2|Outcome|Eprosartan Mesylate|Eprosartan Mesylate 600 mg + Placebo Eprosartan
182936|NCT01631227|O1|Outcome|Eprosartan|Eprosartan 450 mg + Placebo Eprosartan Mesylate
182937|NCT01631227|E2|Reported Event|Eprosartan Mesylate|Eprosartan Mesylate 600 mg + Placebo Eprosartan
182938|NCT01631227|E1|Reported Event|Eprosartan|Eprosartan 450 mg + Placebo Eprosartan Mesylate
182939|NCT01631149|B3|Baseline|Total|Total of all reporting groups
182940|NCT01631149|B2|Baseline|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
182941|NCT01631149|B1|Baseline|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
182942|NCT01631149|P2|Participant Flow|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
182943|NCT01631149|P1|Participant Flow|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
182944|NCT01631149|O2|Outcome|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
182945|NCT01631149|O1|Outcome|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
182946|NCT01631149|O2|Outcome|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
182947|NCT01631149|O1|Outcome|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
182948|NCT01631149|O2|Outcome|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
182949|NCT01631149|O1|Outcome|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
182950|NCT01631149|O2|Outcome|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
182951|NCT01631149|O1|Outcome|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
182952|NCT01631149|O2|Outcome|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
182953|NCT01631149|O1|Outcome|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
182954|NCT01631149|E2|Reported Event|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
182955|NCT01631149|E1|Reported Event|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
182956|NCT01631110|B3|Baseline|Total|Total of all reporting groups
182957|NCT01631110|B2|Baseline|Adults From 18 to 60 Years Old Inclusive|
182958|NCT01631110|B1|Baseline|Elderly Subjects Aged Over 60 Years|
182959|NCT01631110|P2|Participant Flow|Adults From 18 to 60 Years Old Inclusive|
182960|NCT01631110|P1|Participant Flow|Elderly Subjects Aged Over 60 Years|
182961|NCT01631110|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
182962|NCT01631110|O1|Outcome|Elderly Subjects Aged Over 60 Years|
182963|NCT01631110|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
182964|NCT01631110|O1|Outcome|Elderly Subjects Aged Over 60 Years|
182965|NCT01631110|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
182966|NCT01631110|O1|Outcome|Elderly Subjects Aged Over 60 Years|
182967|NCT01631110|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
182968|NCT01631110|O1|Outcome|Elderly Subjects Aged Over 60 Years|
182969|NCT01631110|E2|Reported Event|Adults From 18 to 60 Years Old Inclusive|
182970|NCT01631110|E1|Reported Event|Elderly Subjects Aged Over 60 Years|
182974|NCT01631071|P2|Participant Flow|Adults From 18 to 60 Years Old Inclusive|
182975|NCT01631071|P1|Participant Flow|Elderly Subjects Aged Over 60 Years|
182976|NCT01631071|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
182977|NCT01631071|O1|Outcome|Elderly Subjects Aged Over 60 Years|
182978|NCT01631071|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
182979|NCT01631071|O1|Outcome|Elderly Subjects Aged Over 60 Years|
182980|NCT01631071|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
182981|NCT01631071|O1|Outcome|Elderly Subjects Aged Over 60 Years|
182982|NCT01631071|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
182983|NCT01631071|O1|Outcome|Elderly Subjects Aged Over 60 Years|
182984|NCT01631071|E2|Reported Event|Adults From 18 to 60 Years Old Inclusive|
182985|NCT01631071|E1|Reported Event|Elderly Subjects Aged Over 60 Years|
182986|NCT01630811|B1|Baseline|All Study Participants|Participants who were randomized to receive either Nuedexta tablet (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) or Placebo tablet (matching Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg)
182987|NCT01630811|P2|Participant Flow|Placebo First Nuedexta Second|Participants first received Placebo tablet (matching Neudexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks. After a washout period of 4 weeks, they then received Nuedexta tablet (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.
182988|NCT01630811|P1|Participant Flow|Nuedexta First Placebo Second|Participants first received Nuedexta tablet (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks. After a washout period of 4 weeks, they then received Placebo tablet (matching Neudexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.
182989|NCT01630811|O2|Outcome|Placebo|Nuedexta: Nuedexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.
182990|NCT01630811|O1|Outcome|Nuedexta|Nuedexta: Nuedexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.
182991|NCT01630811|O2|Outcome|Placebo|Placebo tablet equivalent to Nuedexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.
182992|NCT01630811|O1|Outcome|Nuedexta|Nuedexta: Nuedexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.
182993|NCT01630811|O2|Outcome|Placebo|Oral, one time daily for 7 days.
182994|NCT01630811|O1|Outcome|Nuedexta|Nuedexta: Nuedexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.
182995|NCT01630811|E2|Reported Event|Placebo|Placebo tablet equivalent to Nuedexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.
182996|NCT01630811|E1|Reported Event|Nuedexta|Nuedexta: Nuedexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.
182997|NCT01630694|B3|Baseline|Total|Total of all reporting groups
182998|NCT01630694|B2|Baseline|Control|"Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
182999|NCT01630694|B1|Baseline|Difficult Intubation Patients|"Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
183000|NCT01630694|P2|Participant Flow|Control|"Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
183001|NCT01630694|P1|Participant Flow|Difficult Intubation Patients|"Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
183002|NCT01630694|O2|Outcome|Control|"Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
183003|NCT01630694|O1|Outcome|Difficult Intubation Patients|"Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
183004|NCT01630694|O2|Outcome|Control|"Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
183005|NCT01630694|O1|Outcome|Difficult Intubation Patients|"Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
183044|NCT01630616|O1|Outcome|Adolescents Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
194296|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
183006|NCT01630694|E2|Reported Event|Control|"Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
183007|NCT01630694|E1|Reported Event|Difficult Intubation Patients|"Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
183008|NCT01630616|B7|Baseline|Total|Total of all reporting groups
183009|NCT01630616|B6|Baseline|Young Adults Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
183010|NCT01630616|B5|Baseline|Young Adults Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
183011|NCT01630616|B4|Baseline|Young Adults Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to young adults (historical study MK-0822-007).
183012|NCT01630616|B3|Baseline|Adolescents Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
183013|NCT01630616|B2|Baseline|Adolescents Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
183014|NCT01630616|B1|Baseline|Adolescents Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
183015|NCT01630616|P6|Participant Flow|Young Adults Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
183016|NCT01630616|P5|Participant Flow|Young Adults Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
183017|NCT01630616|P4|Participant Flow|Young Adults Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to young adults (historical study MK-0822-007).
183018|NCT01630616|P3|Participant Flow|Adolescents Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
183019|NCT01630616|P2|Participant Flow|Adolescents Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
183020|NCT01630616|P1|Participant Flow|Adolescents Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
183021|NCT01630616|O6|Outcome|Young Adults Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
183022|NCT01630616|O5|Outcome|Young Adults Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
183023|NCT01630616|O4|Outcome|Young Adults Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to young adults (historical study MK-0822-007).
183024|NCT01630616|O3|Outcome|Adolescents Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
183025|NCT01630616|O2|Outcome|Adolescents Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
183026|NCT01630616|O1|Outcome|Adolescents Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
183027|NCT01630616|O6|Outcome|Young Adults Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
183028|NCT01630616|O5|Outcome|Young Adults Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
183029|NCT01630616|O4|Outcome|Young Adults Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to young adults (historical study MK-0822-007).
183030|NCT01630616|O3|Outcome|Adolescents Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
183031|NCT01630616|O2|Outcome|Adolescents Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
183032|NCT01630616|O1|Outcome|Adolescents Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
183033|NCT01630616|O6|Outcome|Young Adults Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
183034|NCT01630616|O5|Outcome|Young Adults Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
183035|NCT01630616|O4|Outcome|Young Adults Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to young adults (historical study MK-0822-007).
183036|NCT01630616|O3|Outcome|Adolescents Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
183037|NCT01630616|O2|Outcome|Adolescents Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
183038|NCT01630616|O1|Outcome|Adolescents Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
183039|NCT01630616|O6|Outcome|Young Adults Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
183040|NCT01630616|O5|Outcome|Young Adults Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
183041|NCT01630616|O4|Outcome|Young Adults Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to young adults (historical study MK-0822-007).
183042|NCT01630616|O3|Outcome|Adolescents Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
183043|NCT01630616|O2|Outcome|Adolescents Odanacatib 50|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
183045|NCT01630616|O6|Outcome|Young Adults Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
183046|NCT01630616|O5|Outcome|Young Adults Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
183047|NCT01630616|O4|Outcome|Young Adults Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to young adults (historical study MK-0822-007).
183048|NCT01630616|O3|Outcome|Adolescents Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
183049|NCT01630616|O2|Outcome|Adolescents Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
183050|NCT01630616|O1|Outcome|Adolescents Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
183051|NCT01630616|O5|Outcome|Young Adults Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
183052|NCT01630616|O4|Outcome|Young Adults Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
183053|NCT01630616|O3|Outcome|Adolescents Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
183054|NCT01630616|O2|Outcome|Adolescents Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
183055|NCT01630616|O1|Outcome|Adolescents Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
183056|NCT01630616|O5|Outcome|Young Adults Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
183057|NCT01630616|O4|Outcome|Young Adults Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
183058|NCT01630616|O3|Outcome|Adolescents Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
183059|NCT01630616|O2|Outcome|Adolescents Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
183060|NCT01630616|O1|Outcome|Adolescents Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
183061|NCT01630616|O5|Outcome|Young Adults Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
183062|NCT01630616|O4|Outcome|Young Adults Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
183063|NCT01630616|O3|Outcome|Adolescents Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
183064|NCT01630616|O2|Outcome|Adolescents Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
183065|NCT01630616|O1|Outcome|Adolescents Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
183066|NCT01630616|O5|Outcome|Young Adults Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
183067|NCT01630616|O4|Outcome|Young Adults Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
183068|NCT01630616|O3|Outcome|Adolescents Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
183069|NCT01630616|O2|Outcome|Adolescents Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
183070|NCT01630616|O1|Outcome|Adolescents Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
183071|NCT01630616|O5|Outcome|Young Adults Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
183072|NCT01630616|O4|Outcome|Young Adults Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
183073|NCT01630616|O3|Outcome|Adolescents Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
183074|NCT01630616|O2|Outcome|Adolescents Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
183075|NCT01630616|O1|Outcome|Adolescents Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
183076|NCT01630616|O5|Outcome|Young Adults Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
183077|NCT01630616|O4|Outcome|Young Adults Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
183078|NCT01630616|O3|Outcome|Adolescents Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
183079|NCT01630616|O2|Outcome|Adolescents Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
183080|NCT01630616|O1|Outcome|Adolescents Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
183081|NCT01630616|O5|Outcome|Young Adults Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
183082|NCT01630616|O4|Outcome|Young Adults Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
183083|NCT01630616|O3|Outcome|Adolescents Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
183084|NCT01630616|O2|Outcome|Adolescents Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
183085|NCT01630616|O1|Outcome|Adolescents Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
183086|NCT01630616|E6|Reported Event|Young Adults Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to young adults (historical study MK-0822-007).
183087|NCT01630616|E5|Reported Event|Young Adults Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
183088|NCT01630616|E4|Reported Event|Young Adults Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
183089|NCT01630616|E3|Reported Event|Adolescents Placebo|Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
183090|NCT01630616|E2|Reported Event|Adolescents Odanacatib 50 mg|Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
183091|NCT01630616|E1|Reported Event|Adolescents Odanacatib 10 mg|Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
183092|NCT01630135|B3|Baseline|Total|Total of all reporting groups
183093|NCT01630135|B2|Baseline|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
183094|NCT01630135|B1|Baseline|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
183095|NCT01630135|P2|Participant Flow|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
183096|NCT01630135|P1|Participant Flow|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
183097|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
183098|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
183099|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
183100|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
183101|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
183102|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
183103|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
183104|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
183105|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
183106|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
183107|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
183108|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
183109|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
183110|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
183111|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
183112|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
183113|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
183114|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
183115|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
183116|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
183117|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
183118|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
183119|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
183120|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
183121|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
183122|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
183123|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
183124|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
183125|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
183126|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
183127|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
183128|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
183129|NCT01630135|E2|Reported Event|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
183130|NCT01630135|E1|Reported Event|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
183131|NCT01630109|B4|Baseline|Total|Total of all reporting groups
183132|NCT01630109|B3|Baseline|Placebo Control|Placebo to be used as the control group
183133|NCT01630109|B2|Baseline|Metoclopramide 10 mg|Pro-motility agent
183134|NCT01630109|B1|Baseline|Metoclopramide 5 mg|Pro-motility agent
183135|NCT01630109|P3|Participant Flow|Placebo Control|Placebo to be used as the control group
183136|NCT01630109|P2|Participant Flow|Metoclopramide 10 mg|Pro-motility agent
183137|NCT01630109|P1|Participant Flow|Metoclopramide 5 mg|Pro-motility agent
183138|NCT01630109|O6|Outcome|Placebo (Non-diabetic)|Placebo control given to non-diabetics
183139|NCT01630109|O5|Outcome|Metoclopramide 10 mg (Non-diabetic)|Pro-motility agent given to non-diabetic patients
183140|NCT01630109|O4|Outcome|Metoclopramide 5 mg (Non-diabetic)|Pro-motility agent given to non-diabetic patients
183141|NCT01630109|O3|Outcome|Placebo Control (Diabetics)|Placebo to be used as the control group in diabetic patients
183142|NCT01630109|O2|Outcome|Metoclopramide 10 mg (Diabetics)|Pro-motility agent given to diabetic patients
183143|NCT01630109|O1|Outcome|Metoclopramide 5 mg (Diabetics)|Pro-motility agent given to diabetic patients
183144|NCT01630109|O3|Outcome|Placebo Control|Placebo to be used as the control group
183145|NCT01630109|O2|Outcome|Metoclopramide 10 mg|Pro-motility agent
183146|NCT01630109|O1|Outcome|Metoclopramide 5 mg|Pro-motility agent
183147|NCT01630109|O3|Outcome|Placebo Control|Placebo to be used as the control group
183148|NCT01630109|O2|Outcome|Metoclopramide 10 mg|Pro-motility agent
183149|NCT01630109|O1|Outcome|Metoclopramide 5 mg|Pro-motility agent
183150|NCT01630109|O3|Outcome|Placebo Control|Placebo to be used as the control group
183151|NCT01630109|O2|Outcome|Metoclopramide 10 mg|Pro-motility agent
183152|NCT01630109|O1|Outcome|Metoclopramide 5 mg|Pro-motility agent
183153|NCT01630109|E3|Reported Event|Placebo Control|Placebo to be used as the control group
183154|NCT01630109|E2|Reported Event|Metoclopramide 10 mg|Pro-motility agent
183155|NCT01630109|E1|Reported Event|Metoclopramide 5 mg|Pro-motility agent
183156|NCT01629953|B3|Baseline|Total|Total of all reporting groups
183157|NCT01629953|B2|Baseline|Supported Employment Condition|"Group vocational intervention + supported employment~Supported Employment Condition: Veterans in this condition will receive a proven group based manualized vocational rehabilitation intervention"
183158|NCT01629953|B1|Baseline|Group Based Vocational Rehabilitation|"Group vocational intervention~Group vocational intervention: Group based manualized vocational rehabilitation"
183159|NCT01629953|P2|Participant Flow|Supported Employment Condition|"Group vocational intervention + supported employment~Supported Employment Condition: Veterans in this condition will receive a proven group based manualized vocational rehabilitation intervention"
183160|NCT01629953|P1|Participant Flow|Group Based Vocational Rehabilitation|"Group vocational intervention~Group vocational intervention: Group based manualized vocational rehabilitation"
183161|NCT01629953|O2|Outcome|Supported Employment Condition|"Group vocational intervention + supported employment~Supported Employment Condition: Veterans in this condition will receive a proven group based manualized vocational rehabilitation intervention"
183162|NCT01629953|O1|Outcome|Group Based Vocational Rehabilitation|"Group vocational intervention~Group vocational intervention: Group based manualized vocational rehabilitation"
183163|NCT01629953|O2|Outcome|Supported Employment Condition|"Group vocational intervention + supported employment~Supported Employment Condition: Veterans in this condition will receive a proven group based manualized vocational rehabilitation intervention"
183164|NCT01629953|O1|Outcome|Group Based Vocational Rehabilitation|"Group vocational intervention~Group vocational intervention: Group based manualized vocational rehabilitation"
183165|NCT01629953|E2|Reported Event|Supported Employment Condition|"Group vocational intervention + supported employment~Supported Employment Condition: Veterans in this condition will receive a proven group based manualized vocational rehabilitation intervention"
183166|NCT01629953|E1|Reported Event|Group Based Vocational Rehabilitation|"Group vocational intervention~Group vocational intervention: Group based manualized vocational rehabilitation"
183167|NCT01629862|B3|Baseline|Total|Total of all reporting groups
183168|NCT01629862|B2|Baseline|Sham CPAP|"Sham (non-therapeutic) continuous positive airway pressure.~Sham continuous positive airway pressure: CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia)."
183169|NCT01629862|B1|Baseline|Active CPAP|"Therapeutic continuous positive airway pressure (CPAP).~Continuous positive airway pressure: CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia)."
183243|NCT01629693|B2|Baseline|Biofinity|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
183170|NCT01629862|P2|Participant Flow|Sham CPAP|"Sham (non-therapeutic) continuous positive airway pressure.~Sham continuous positive airway pressure: CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia)."
183171|NCT01629862|P1|Participant Flow|Active CPAP|"Therapeutic continuous positive airway pressure (CPAP).~Continuous positive airway pressure: CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia)."
183172|NCT01629862|O2|Outcome|Sham CPAP|"Sham (non-therapeutic) continuous positive airway pressure.~Sham continuous positive airway pressure: CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia)."
183173|NCT01629862|O1|Outcome|Active CPAP|"Therapeutic continuous positive airway pressure (CPAP).~Continuous positive airway pressure: CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia)."
183174|NCT01629862|E2|Reported Event|Sham CPAP|"Sham (non-therapeutic) continuous positive airway pressure.~Sham continuous positive airway pressure: CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia)."
183175|NCT01629862|E1|Reported Event|Active CPAP|"Therapeutic continuous positive airway pressure (CPAP).~Continuous positive airway pressure: CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia)."
183176|NCT01629823|B4|Baseline|Total|Total of all reporting groups
183177|NCT01629823|B3|Baseline|CPAP 10cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
183178|NCT01629823|B2|Baseline|CPAP 5cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
183179|NCT01629823|B1|Baseline|CPAP Less Than 1 cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
183180|NCT01629823|P3|Participant Flow|CPAP 10cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks.
183181|NCT01629823|P2|Participant Flow|CPAP 5cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks.
183182|NCT01629823|P1|Participant Flow|CPAP Less Than 1 cm Water (H₂O)|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks.
183183|NCT01629823|O3|Outcome|CPAP 10cm H2O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
183184|NCT01629823|O2|Outcome|CPAP 5cm H2O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
183185|NCT01629823|O1|Outcome|CPAP Less Than 1 cm H2O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
183186|NCT01629823|E3|Reported Event|CPAP 10cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
183187|NCT01629823|E2|Reported Event|CPAP 5cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
183188|NCT01629823|E1|Reported Event|CPAP Less Than 1 cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
183244|NCT01629693|B1|Baseline|Air Optix|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
183245|NCT01629693|P2|Participant Flow|Biofinity|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
183246|NCT01629693|P1|Participant Flow|Air Optix|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
183189|NCT01629797|B1|Baseline|Acne Vulgaris|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture. Two months after the educational lecture, subjects were contacted by phone to complete a final questionnaire to assess knowledge about acne.
183190|NCT01629797|P1|Participant Flow|Acne Vulgaris|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture. Two months after the educational lecture, subjects were contacted by phone to complete a final questionnaire to assess knowledge about acne.
183191|NCT01629797|O2|Outcome|Two Months Post-educational Lecture|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture. Two months after the educational lecture, subjects were contacted by phone to complete a final questionnaire to assess knowledge about acne.
183192|NCT01629797|O1|Outcome|Pre-educational Lecture|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture. Two months after the educational lecture, subjects were contacted by phone to complete a final questionnaire to assess knowledge about acne.
183193|NCT01629797|O2|Outcome|Post-educational Lecture|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture.
183194|NCT01629797|O1|Outcome|Pre-educational Lecture|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture.
183195|NCT01629797|E1|Reported Event|Acne Vulgaris|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture. Two months after the educational lecture, subjects were contacted by phone to complete a final questionnaire to assess knowledge about acne.
183196|NCT01629784|B1|Baseline|Cutaneous Lupus Erythematosus (CLE)|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a post-lecture written questionnaire to assess knowledge about CLE and sun protection. Three months after the educational lecture, subjects were contacted by phone to complete a final knowledge and behavioral assessment.
183197|NCT01629784|P1|Participant Flow|Cutaneous Lupus Erythematosus (CLE)|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a post-lecture written questionnaire to assess knowledge about CLE and sun protection. Three months after the educational lecture, subjects were contacted by phone to complete a final knowledge and behavioral assessment.
183198|NCT01629784|O2|Outcome|Three Months Post-educational Lecture|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection. 3 months later, subjects were contacted by phone to complete a knowledge and behavioral assessment about CLE and sun protection.
183199|NCT01629784|O1|Outcome|Pre-educational Lecture|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection. 3 months later, subjects were contacted by phone to complete a knowledge and behavioral assessment about CLE and sun protection.
183200|NCT01629784|O2|Outcome|Post-educational Lecture|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a written questionnaire to assess knowledge about CLE and sun protection.
183201|NCT01629784|O1|Outcome|Pre-educational Lecture|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a written questionnaire to assess knowledge about CLE and sun protection.
194297|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
183202|NCT01629784|E1|Reported Event|Cutaneous Lupus Erythematosus (CLE)|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a post-lecture written questionnaire to assess knowledge about CLE and sun protection. Three months after the educational lecture, subjects were contacted by phone to complete a final knowledge and behavioral assessment.
183203|NCT01629771|B3|Baseline|Total|Total of all reporting groups
183204|NCT01629771|B2|Baseline|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
183205|NCT01629771|B1|Baseline|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
183206|NCT01629771|P2|Participant Flow|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
183207|NCT01629771|P1|Participant Flow|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
183208|NCT01629771|O2|Outcome|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
183209|NCT01629771|O1|Outcome|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
183210|NCT01629771|O2|Outcome|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
183211|NCT01629771|O1|Outcome|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
183212|NCT01629771|O2|Outcome|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
183213|NCT01629771|O1|Outcome|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
183214|NCT01629771|E2|Reported Event|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
183215|NCT01629771|E1|Reported Event|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
183216|NCT01629706|B1|Baseline|Overall|All enrolled participants
183217|NCT01629706|P1|Participant Flow|PureVision/Habitual|Phase 1: Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for two hours and four hours at a time, separate days, with Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in the fellow eye. Phase 2: Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care.
183218|NCT01629706|O2|Outcome|Symptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
183219|NCT01629706|O1|Outcome|Asymptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
183220|NCT01629706|O2|Outcome|Symptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
183221|NCT01629706|O1|Outcome|Asymptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
183222|NCT01629706|O2|Outcome|Symptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
183223|NCT01629706|O1|Outcome|Asymptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
183224|NCT01629706|O2|Outcome|Symptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
183225|NCT01629706|O1|Outcome|Asymptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
183226|NCT01629706|O2|Outcome|Symptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
183227|NCT01629706|O1|Outcome|Asymptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
183228|NCT01629706|O2|Outcome|Symptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
183229|NCT01629706|O1|Outcome|Asymptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
183230|NCT01629706|O2|Outcome|PV+Renu|Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days
183231|NCT01629706|O1|Outcome|PV+ClearCare|Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for 2 hours and 4 hours, separate days
183232|NCT01629706|O2|Outcome|PV+Renu|Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days
183233|NCT01629706|O1|Outcome|PV+ClearCare|Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for 2 hours and 4 hours, separate days
183234|NCT01629706|O2|Outcome|PV+Renu|Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days
183235|NCT01629706|O1|Outcome|PV+ClearCare|Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for 2 hours and 4 hours, separate days
183236|NCT01629706|O2|Outcome|PV+Renu|Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days
183237|NCT01629706|O1|Outcome|PV+ClearCare|Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for 2 hours and 4 hours, separate days
183238|NCT01629706|O2|Outcome|PV+Renu|Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days
183239|NCT01629706|O1|Outcome|PV+ClearCare|Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for 2 hours and 4 hours, separate days
183240|NCT01629706|E2|Reported Event|Habitual|Habitual contact lenses worn in Phase 2
183241|NCT01629706|E1|Reported Event|PureVision|Balafilcon A contact lenses worn in Phase 1
183242|NCT01629693|B3|Baseline|Total|Total of all reporting groups
183298|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183247|NCT01629693|O2|Outcome|Biofinity|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
183248|NCT01629693|O1|Outcome|Air Optix|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
183249|NCT01629693|E2|Reported Event|Biofinity|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
183250|NCT01629693|E1|Reported Event|Air Optix|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
183251|NCT01629667|B4|Baseline|Total|Total of all reporting groups
183252|NCT01629667|B3|Baseline|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183253|NCT01629667|B2|Baseline|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183254|NCT01629667|B1|Baseline|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183255|NCT01629667|P3|Participant Flow|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183256|NCT01629667|P2|Participant Flow|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183257|NCT01629667|P1|Participant Flow|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183258|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183259|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183260|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183261|NCT01629667|O2|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183262|NCT01629667|O1|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183263|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183264|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183265|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183266|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183267|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183268|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183269|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183270|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183271|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183272|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183273|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183274|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183275|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183276|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183277|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183278|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183279|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183280|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183281|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183282|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183283|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183284|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183285|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183286|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183287|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183288|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183289|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183290|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183291|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183292|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183293|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183294|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183295|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183296|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183297|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183396|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab.
183299|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183300|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183301|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183302|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183303|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183304|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183305|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183306|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183307|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183308|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183309|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183310|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183311|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183312|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183313|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183314|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183315|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183316|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183317|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183318|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183319|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183320|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183321|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183322|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183323|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183324|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183325|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183326|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183327|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183328|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183329|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183330|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183331|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183332|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183333|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183334|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183335|NCT01629667|E3|Reported Event|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
183336|NCT01629667|E2|Reported Event|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
183337|NCT01629667|E1|Reported Event|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
183338|NCT01629589|B3|Baseline|Total|Total of all reporting groups
183339|NCT01629589|B2|Baseline|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
183340|NCT01629589|B1|Baseline|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
183341|NCT01629589|P2|Participant Flow|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
183342|NCT01629589|P1|Participant Flow|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
183343|NCT01629589|O2|Outcome|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
183344|NCT01629589|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
183345|NCT01629589|O2|Outcome|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
183346|NCT01629589|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
183347|NCT01629589|O2|Outcome|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
183348|NCT01629589|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
183349|NCT01629589|O2|Outcome|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
183350|NCT01629589|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
183351|NCT01629589|O2|Outcome|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
183352|NCT01629589|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
183353|NCT01629589|O2|Outcome|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
183354|NCT01629589|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
183355|NCT01629589|E2|Reported Event|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
183356|NCT01629589|E1|Reported Event|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
183357|NCT01629290|B1|Baseline|Varnish and Placebo|Three dental varnishes with 5% NaF active ingredient and placebo bland varnish containing no NaF
183358|NCT01629290|P1|Participant Flow|Varnishes and Placebo|"Three dental varnishes with 5% NaF active ingredient (Enamel Pro, Duraphat and Vanish) and one bland varnish with no NaF applied to each subject at four timepoints.~Each of the 15 participants received each of the four treatments, but the order followed was randomly arranged to be different, so there were twelve different patterns of assignment. Because all participants completed all four interventions, and the order was different for each, milestones are not used to indicate participation in each treatment, as that might imply a sequence, rather than simply that they received that intervention."
183359|NCT01629290|O4|Outcome|Placebo|Bland varnish containing no NaF
183360|NCT01629290|O3|Outcome|Vanish|Dental varnish with 5% NaF active ingredient
183361|NCT01629290|O2|Outcome|Duraphat|Dental varnish with 5% NaF active ingredient
183362|NCT01629290|O1|Outcome|Enamel Pro|Dental varnish with 5% NaF active ingredient
183363|NCT01629290|E4|Reported Event|Vanish|Dental varnish with 5% NaF active ingredient
183364|NCT01629290|E3|Reported Event|Duraphat|Dental varnish with 5% NaF active ingredient
183365|NCT01629290|E2|Reported Event|Placebo|Placebo bland varnish containing no NaF
183366|NCT01629290|E1|Reported Event|Enamel Pro|Dental varnish with 5% NaF active ingredient
183367|NCT01629134|B1|Baseline|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
183368|NCT01629134|P1|Participant Flow|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
183369|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
183370|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
183371|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
183372|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
183373|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
183374|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
183375|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
183376|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
183377|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
183378|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
183379|NCT01629134|E1|Reported Event|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
183380|NCT01628965|B1|Baseline|SPM 962|SPM 962 transdermal patch
183381|NCT01628965|P1|Participant Flow|SPM 962|SPM 962 transdermal patch
183382|NCT01628965|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
183383|NCT01628965|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
183384|NCT01628965|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
183385|NCT01628965|E1|Reported Event|SPM 962|SPM 962 transdermal patch
183386|NCT01628926|B4|Baseline|Total|Total of all reporting groups
183387|NCT01628926|B3|Baseline|Placebo|SPM962 placebo patch and Ropinirole placebo tab
183388|NCT01628926|B2|Baseline|Ropinirole|Ropinirole tablet
183389|NCT01628926|B1|Baseline|SPM 962|SPM 962 transdermal patch
183390|NCT01628926|P3|Participant Flow|Placebo|SPM962 placebo patch and Ropinirole placebo tab
183391|NCT01628926|P2|Participant Flow|Ropinirole|Ropinirole tablet
183392|NCT01628926|P1|Participant Flow|SPM 962|SPM 962 transdermal patch
183393|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
183394|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
183395|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
183397|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
183398|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
183399|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
183400|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
183401|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
183402|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
183403|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
183404|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
183405|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
183406|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
183407|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
183408|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
183409|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
183410|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
183411|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab.
183412|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
183413|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
183414|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
183415|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
183416|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
183417|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
183418|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
183419|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
183420|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
183421|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
183422|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
183423|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
183424|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
183425|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
183426|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
183427|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
183428|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
183429|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
183430|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
183431|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
183432|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
183433|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
183434|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
183435|NCT01628926|E3|Reported Event|Placebo|SPM962 placebo patch and Ropinirole placebo tab
183436|NCT01628926|E2|Reported Event|Ropinirole|Ropinirole tablet
183437|NCT01628926|E1|Reported Event|SPM 962|SPM 962 transdermal patch
183438|NCT01628913|B3|Baseline|Total|Total of all reporting groups
183439|NCT01628913|B2|Baseline|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
183440|NCT01628913|B1|Baseline|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
183441|NCT01628913|P2|Participant Flow|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
183442|NCT01628913|P1|Participant Flow|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
183443|NCT01628913|O2|Outcome|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
183444|NCT01628913|O1|Outcome|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
183445|NCT01628913|O2|Outcome|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
183446|NCT01628913|O1|Outcome|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
183447|NCT01628913|O2|Outcome|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
183448|NCT01628913|O1|Outcome|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
183449|NCT01628913|O2|Outcome|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
183450|NCT01628913|O1|Outcome|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
183451|NCT01628913|E2|Reported Event|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
183452|NCT01628913|E1|Reported Event|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
183453|NCT01628848|B3|Baseline|Total|Total of all reporting groups
183454|NCT01628848|B2|Baseline|Placebo|Placebo transdermal patch
183455|NCT01628848|B1|Baseline|SPM 962|SPM 962 transdermal patch
183456|NCT01628848|P2|Participant Flow|Placebo|Placebo transdermal patch
183457|NCT01628848|P1|Participant Flow|SPM 962|SPM 962 transdermal patch
183458|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
183459|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
183460|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
183461|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
183462|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
183463|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
183464|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
183465|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
183485|NCT01628692|B6|Baseline|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
183486|NCT01628692|B5|Baseline|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
183487|NCT01628692|B4|Baseline|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
183488|NCT01628692|B3|Baseline|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
183489|NCT01628692|B2|Baseline|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
183490|NCT01628692|B1|Baseline|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
183491|NCT01628692|P6|Participant Flow|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
183492|NCT01628692|P5|Participant Flow|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
183493|NCT01628692|P4|Participant Flow|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
183494|NCT01628692|P3|Participant Flow|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
183495|NCT01628692|P2|Participant Flow|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
183496|NCT01628692|P1|Participant Flow|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
183497|NCT01628692|O3|Outcome|Genotype1a: Daclatasvir +Simeprevir + Ribavirin(Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1a and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
183498|NCT01628692|O2|Outcome|Genotype1b: Daclatasvir +Simeprevir + Ribavirin (Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
183550|NCT01628601|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
183551|NCT01628601|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
183499|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
183500|NCT01628692|O6|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
183501|NCT01628692|O5|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
183502|NCT01628692|O4|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
183503|NCT01628692|O3|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
183504|NCT01628692|O2|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
183505|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
183506|NCT01628692|O6|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
183507|NCT01628692|O5|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
183508|NCT01628692|O4|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
183509|NCT01628692|O3|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
183510|NCT01628692|O2|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
183511|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
183512|NCT01628692|O6|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
183513|NCT01628692|O5|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
183552|NCT01628601|E1|Reported Event|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
183514|NCT01628692|O4|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
183515|NCT01628692|O3|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
183516|NCT01628692|O2|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
183517|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
183518|NCT01628692|O6|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
183519|NCT01628692|O5|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
183520|NCT01628692|O4|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
183521|NCT01628692|O3|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
183522|NCT01628692|O2|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up
183523|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
183524|NCT01628692|O6|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
183525|NCT01628692|O5|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
183526|NCT01628692|O4|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
183527|NCT01628692|O3|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
183528|NCT01628692|O2|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
183529|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
183530|NCT01628692|O6|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks
183531|NCT01628692|O5|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
183532|NCT01628692|O4|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
183533|NCT01628692|O3|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
183534|NCT01628692|O2|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
183535|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
183536|NCT01628692|E3|Reported Event|Genotype1a: Daclatasvir +Simeprevir + Ribavirin (Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1a and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
183537|NCT01628692|E2|Reported Event|Genotype1b: Daclatasvir +Simeprevir + Ribavirin (Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
183538|NCT01628692|E1|Reported Event|Genotype 1b: Daclatasvir + Simeprevir (Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
183539|NCT01628614|B1|Baseline|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
183540|NCT01628614|P1|Participant Flow|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
183541|NCT01628614|O1|Outcome|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
183542|NCT01628614|O1|Outcome|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
183543|NCT01628614|O1|Outcome|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
183544|NCT01628614|E1|Reported Event|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
183545|NCT01628601|B1|Baseline|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
183546|NCT01628601|P1|Participant Flow|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
183547|NCT01628601|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
183548|NCT01628601|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
183549|NCT01628601|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
183553|NCT01628588|B1|Baseline|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
183554|NCT01628588|P1|Participant Flow|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
183555|NCT01628588|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
183556|NCT01628588|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
183557|NCT01628588|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
183558|NCT01628588|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
183559|NCT01628588|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
183560|NCT01628588|E1|Reported Event|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
183561|NCT01628510|B3|Baseline|Total|Total of all reporting groups
183562|NCT01628510|B2|Baseline|Dandle Roo/Dandle Wrap|"The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the neurodevelopment of the preterm infant, and this device is produced by Dandle Lion Medical. The Dandle Roo/Wrap provides all around contact, containment, and proprioceptive input, (which more closely mimics the uterine environment) and can decrease excitability and promote self-regulation, while also allowing for movement with recoil back to flexion.~Dandle Roo/Dandle Wrap: Infant remains in the Dandle Roo/Dandle Wrap throughout the NICU stay when teh infant is lying in the isolette or crib, but is taken out for hands on care times or when held."
183563|NCT01628510|B1|Baseline|Traditional NICU Positioning|"Methods of positioning in the NICU have been used for several decades. These methods aim at providing containment and flexion and may consist of swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper® The continued use of these methods of positioning is the control group in the current study.~Traditional Positioning: Traditional positioning methods are used with the infant throughout the NICU hospitalization."
183564|NCT01628510|P2|Participant Flow|Traditional NICU Positioning|Methods of positioning in the NICU have been used for several decades. These methods aim at providing containment and flexion and may consist of swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper® The continued use of these methods of positioning is the control group in the current study.
183565|NCT01628510|P1|Participant Flow|Dandle Roo/Dandle Wrap|The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the neurodevelopment of the preterm infant, and this device is produced by Dandle Lion Medical. The Dandle Roo/Wrap provides all around contact, containment, and proprioceptive input, (which more closely mimics the uterine environment) and can decrease excitability and promote self-regulation, while also allowing for movement with recoil back to flexion.
183566|NCT01628510|O2|Outcome|Dandle Roo/Dandle Wrap|"The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the neurodevelopment of the preterm infant, and this device is produced by Dandle Lion Medical. The Dandle Roo/Wrap provides all around contact, containment, and proprioceptive input, (which more closely mimics the uterine environment) and can decrease excitability and promote self-regulation, while also allowing for movement with recoil back to flexion.~Dandle Roo/Dandle Wrap: Infant remains in the Dandle Roo/Dandle Wrap throughout the NICU stay when the infant is lying in the isolette or crib, but is taken out for hands on care times or when held."
183567|NCT01628510|O1|Outcome|Traditional NICU Positioning|"Methods of positioning in the NICU have been used for several decades. These methods aim at providing containment and flexion and may consist of interventions such as swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper® The continued use of these methods of positioning is the control group in the current study.~Traditional NICU Positioning: These methods aim at providing containment and flexion and may consist of interventions such as swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper®"
183568|NCT01628510|O2|Outcome|Dandle Roo/Dandle Wrap|"The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the neurodevelopment of the preterm infant, and this device is produced by Dandle Lion Medical. The Dandle Roo/Wrap provides all around contact, containment, and proprioceptive input, (which more closely mimics the uterine environment) and can decrease excitability and promote self-regulation, while also allowing for movement with recoil back to flexion.~Dandle Roo/Dandle Wrap: Infant remains in the Dandle Roo/Dandle Wrap throughout the NICU stay when teh infant is lying in the isolette or crib, but is taken out for hands on care times or when held."
183569|NCT01628510|O1|Outcome|Traditional NICU Positioning|"Methods of positioning in the NICU have been used for several decades. These methods aim at providing containment and flexion and may consist of swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper® The continued use of these methods of positioning is the control group in the current study.~Traditional Positioning: Traditional positioning methods are used with the infant throughout the NICU hospitalization."
183570|NCT01628510|E2|Reported Event|Traditional NICU Positioning|Methods of positioning in the NICU have been used for several decades. These methods aim at providing containment and flexion and may consist of swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper® The continued use of these methods of positioning is the control group in the current study.
183571|NCT01628510|E1|Reported Event|Dandle Roo/Dandle Wrap|The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the neurodevelopment of the preterm infant, and this device is produced by Dandle Lion Medical. The Dandle Roo/Wrap provides all around contact, containment, and proprioceptive input, (which more closely mimics the uterine environment) and can decrease excitability and promote self-regulation, while also allowing for movement with recoil back to flexion.
183572|NCT01628367|B3|Baseline|Total|Total of all reporting groups
183586|NCT01628250|B2|Baseline|D3 Laparoscopic Colectomy|"Randomized group of patients receiving laparoscopic colectomy with D3-resection~D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications."
183573|NCT01628367|B2|Baseline|Control|"Collagen plug:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.~Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
183574|NCT01628367|B1|Baseline|Test|"Membrane:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.~Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
183575|NCT01628367|P2|Participant Flow|Control|"Collagen plug:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.~Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
183576|NCT01628367|P1|Participant Flow|Test|"Membrane:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.~Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
183577|NCT01628367|O2|Outcome|Control|"Collagen plug:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.~Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
183578|NCT01628367|O1|Outcome|Test|"Membrane:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.~Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
183579|NCT01628367|O2|Outcome|Control|"Collagen plug:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.~Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
183580|NCT01628367|O1|Outcome|Test|"Membrane:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.~Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
183581|NCT01628367|O2|Outcome|Control|"Collagen plug:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.~Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
183582|NCT01628367|O1|Outcome|Test|"Membrane:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.~Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
183583|NCT01628367|E2|Reported Event|Control|"Collagen plug:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.~Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
183584|NCT01628367|E1|Reported Event|Test|"Membrane:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.~Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
183585|NCT01628250|B3|Baseline|Total|Total of all reporting groups
183587|NCT01628250|B1|Baseline|Laparoscopic Complete Mesocolic Excision|"Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision~laparoscopic complete mesocolic excision: laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized."
183588|NCT01628250|P2|Participant Flow|D3 Laparoscopic Colectomy|"Randomized group of patients receiving laparoscopic colectomy with D3-resection~D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications."
183589|NCT01628250|P1|Participant Flow|Laparoscopic Complete Mesocolic Excision|"Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision~laparoscopic complete mesocolic excision: laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized."
183590|NCT01628250|O2|Outcome|D3 Laparoscopic Colectomy|"Randomized group of patients receiving laparoscopic colectomy with D3-resection~D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications."
183591|NCT01628250|O1|Outcome|Laparoscopic Complete Mesocolic Excision|"Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision~laparoscopic complete mesocolic excision: laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized."
183592|NCT01628250|E2|Reported Event|D3 Laparoscopic Colectomy|"Randomized group of patients receiving laparoscopic colectomy with D3-resection~D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications."
183593|NCT01628250|E1|Reported Event|Laparoscopic Complete Mesocolic Excision|"Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision~laparoscopic complete mesocolic excision: laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized."
183594|NCT01628198|B1|Baseline|Renal Denervation Group|Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
183595|NCT01628198|P1|Participant Flow|Renal Denervation Group|Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
183596|NCT01628198|O1|Outcome|Renal Denervation Group|Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
183597|NCT01628198|O1|Outcome|Renal Denervation Group|Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
183598|NCT01628198|O1|Outcome|Renal Denervation Group|Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
183599|NCT01628198|O1|Outcome|Renal Denervation Group|Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
183600|NCT01628198|O1|Outcome|Renal Denervation Group|Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
183601|NCT01628198|O1|Outcome|Renal Denervation Group|Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
183602|NCT01628198|O1|Outcome|Renal Denervation Group|Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
183603|NCT01628198|O1|Outcome|Renal Denervation Group|Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
183604|NCT01628198|O1|Outcome|Renal Denervation Group|Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
183605|NCT01628198|O1|Outcome|Renal Denervation Group|Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
183606|NCT01628198|E1|Reported Event|Renal Denervation Group|Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
183607|NCT01628042|B5|Baseline|Total|Total of all reporting groups
183608|NCT01628042|B4|Baseline|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
183609|NCT01628042|B3|Baseline|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
183610|NCT01628042|B2|Baseline|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
183611|NCT01628042|B1|Baseline|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
183612|NCT01628042|P4|Participant Flow|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
183613|NCT01628042|P3|Participant Flow|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
183614|NCT01628042|P2|Participant Flow|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
183615|NCT01628042|P1|Participant Flow|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
183616|NCT01628042|O4|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
183617|NCT01628042|O3|Outcome|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
183618|NCT01628042|O2|Outcome|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
183619|NCT01628042|O1|Outcome|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
183620|NCT01628042|O4|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
183621|NCT01628042|O3|Outcome|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
183622|NCT01628042|O2|Outcome|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
183623|NCT01628042|O1|Outcome|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
183624|NCT01628042|O4|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
183625|NCT01628042|O3|Outcome|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
183626|NCT01628042|O2|Outcome|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
183627|NCT01628042|O1|Outcome|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
183628|NCT01628042|E4|Reported Event|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
183629|NCT01628042|E3|Reported Event|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
183630|NCT01628042|E2|Reported Event|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
183631|NCT01628042|E1|Reported Event|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
183632|NCT01627860|B3|Baseline|Total|Total of all reporting groups
183633|NCT01627860|B2|Baseline|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
183634|NCT01627860|B1|Baseline|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
183635|NCT01627860|P2|Participant Flow|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
183636|NCT01627860|P1|Participant Flow|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
183637|NCT01627860|O2|Outcome|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
183638|NCT01627860|O1|Outcome|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
183639|NCT01627860|O2|Outcome|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
183640|NCT01627860|O1|Outcome|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
183680|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
184012|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
183641|NCT01627860|O2|Outcome|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
183642|NCT01627860|O1|Outcome|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
183643|NCT01627860|E2|Reported Event|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
183644|NCT01627860|E1|Reported Event|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
183645|NCT01627782|B5|Baseline|Total|Total of all reporting groups
183646|NCT01627782|B4|Baseline|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
183647|NCT01627782|B3|Baseline|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
183648|NCT01627782|B2|Baseline|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
183649|NCT01627782|B1|Baseline|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
183650|NCT01627782|P4|Participant Flow|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
183651|NCT01627782|P3|Participant Flow|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
183652|NCT01627782|P2|Participant Flow|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
183653|NCT01627782|P1|Participant Flow|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
183654|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
183655|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
183656|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
183657|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
183658|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
183659|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
183660|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
183661|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
183662|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
183663|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
183664|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
183665|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
183666|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
183667|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
183668|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
183669|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
183670|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
183671|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
183672|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
183673|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
183674|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
183675|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
183676|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
183677|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
183678|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
183679|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
183681|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
183682|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
183683|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
183684|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
183685|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
183686|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
183687|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
183688|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
183689|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
183690|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
183691|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
183692|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
183693|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
183694|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
183695|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
183696|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
183697|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
183698|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
183699|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
183700|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
183701|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
183702|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
183703|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
183704|NCT01627782|E4|Reported Event|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
183705|NCT01627782|E3|Reported Event|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
183706|NCT01627782|E2|Reported Event|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
183707|NCT01627782|E1|Reported Event|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
183708|NCT01627561|B3|Baseline|Total|Total of all reporting groups
183709|NCT01627561|B2|Baseline|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
183710|NCT01627561|B1|Baseline|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
183711|NCT01627561|P2|Participant Flow|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
183712|NCT01627561|P1|Participant Flow|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
183713|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
183714|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
183715|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
183716|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
183717|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
183718|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
183719|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
183720|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
183721|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
183722|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
183723|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
183724|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
183725|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
183726|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
183727|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
183728|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
183729|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
183730|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
183731|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
183732|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
183733|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
183734|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
183735|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
183736|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
183737|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
183738|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
183739|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
183740|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
183741|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
183742|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
183743|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
183744|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
183745|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
183746|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
183747|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
183748|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
183749|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
183750|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
183751|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
183752|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
183753|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
183754|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
183755|NCT01627561|E2|Reported Event|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
183756|NCT01627561|E1|Reported Event|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
183757|NCT01627340|B3|Baseline|Total|Total of all reporting groups
183758|NCT01627340|B2|Baseline|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
183759|NCT01627340|B1|Baseline|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
183760|NCT01627340|P2|Participant Flow|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
183761|NCT01627340|P1|Participant Flow|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
183762|NCT01627340|O2|Outcome|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of EngerixTM-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
183763|NCT01627340|O1|Outcome|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of EngerixTM-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
183764|NCT01627340|O2|Outcome|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
183765|NCT01627340|O1|Outcome|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
183766|NCT01627340|O2|Outcome|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
183767|NCT01627340|O1|Outcome|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
183768|NCT01627340|O2|Outcome|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
183769|NCT01627340|O1|Outcome|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
183770|NCT01627340|O2|Outcome|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
183771|NCT01627340|O1|Outcome|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
183772|NCT01627340|O2|Outcome|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
183773|NCT01627340|O1|Outcome|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
183774|NCT01627340|E2|Reported Event|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
183775|NCT01627340|E1|Reported Event|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
183776|NCT01627327|B3|Baseline|Total|Total of all reporting groups
183777|NCT01627327|B2|Baseline|TIO 18 µg OD|Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
183778|NCT01627327|B1|Baseline|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
183779|NCT01627327|P2|Participant Flow|TIO 18 µg OD|Participants received tiotropium bromide (TIO) 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
183780|NCT01627327|P1|Participant Flow|FF/VI 100/25 µg OD|Participants received Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) inhalation once daily (OD) via a dry powder inhaler (DPI) and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
183781|NCT01627327|O2|Outcome|TIO 18 µg OD|Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
183782|NCT01627327|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
183783|NCT01627327|O2|Outcome|TIO 18 µg OD|Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
183784|NCT01627327|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
183785|NCT01627327|O2|Outcome|TIO 18 µg OD|Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
183786|NCT01627327|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
183787|NCT01627327|E2|Reported Event|TIO 18 µg OD|Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
183788|NCT01627327|E1|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
183789|NCT01627249|B4|Baseline|Total|Total of all reporting groups
183790|NCT01627249|B3|Baseline|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab at baseline and up to every 4 weeks using defined retreatment criteria.
183791|NCT01627249|B2|Baseline|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
183792|NCT01627249|B1|Baseline|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
183793|NCT01627249|P3|Participant Flow|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab at baseline and up to every 4 weeks using defined retreatment criteria.
183794|NCT01627249|P2|Participant Flow|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
183795|NCT01627249|P1|Participant Flow|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
183796|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
183797|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
183798|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
183799|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
183800|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
183801|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
183802|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
183803|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
183804|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
183805|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
183806|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
183807|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
183808|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
183809|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
183810|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
183811|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
183812|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
183813|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
183814|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
183815|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
183816|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
183817|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
183818|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
183819|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
183820|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
183821|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
183822|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
183823|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
183824|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
183825|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
183826|NCT01627249|E3|Reported Event|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab at baseline and up to every 4 weeks using defined retreatment criteria.
183827|NCT01627249|E2|Reported Event|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
183828|NCT01627249|E1|Reported Event|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
183829|NCT01627002|B3|Baseline|Total|Total of all reporting groups
183830|NCT01627002|B2|Baseline|Part B|
183831|NCT01627002|B1|Baseline|Part A|
183832|NCT01627002|P9|Participant Flow|Part B Placebo|Placebo was administered 30 minutes after lipopolysaccharide challenge
183833|NCT01627002|P8|Participant Flow|Part B PA401 3.0 mg|PA401 3.0 mg was administered 30 minutes after lipopolysaccharide challenge
183834|NCT01627002|P7|Participant Flow|Part B PA401 1.0 mg|PA401 1.0 mg was administered 30 minutes after lipopolysaccharide challenge
183835|NCT01627002|P6|Participant Flow|Part A Placebo|
183836|NCT01627002|P5|Participant Flow|Part A PA401 10 mg|
183837|NCT01627002|P4|Participant Flow|Part A PA401 3.0 mg|
183838|NCT01627002|P3|Participant Flow|Part A PA401 1.0 mg|
183839|NCT01627002|P2|Participant Flow|Part A PA401 0.3 mg|
183840|NCT01627002|P1|Participant Flow|Part A PA401 0.1 mg|
183841|NCT01627002|O3|Outcome|Part B Placebo|
183842|NCT01627002|O2|Outcome|Part B 1.0 mg PA401|
183891|NCT01626820|B2|Baseline|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
183892|NCT01626820|B1|Baseline|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
183893|NCT01626820|P2|Participant Flow|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm at Day 0
183894|NCT01626820|P1|Participant Flow|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
183895|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
183896|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
183897|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
183898|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
183899|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
183900|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
183901|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
183902|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
183903|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
183904|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
183905|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
183906|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
183907|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
183908|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
183909|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
183910|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
183911|NCT01626820|E2|Reported Event|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
183912|NCT01626820|E1|Reported Event|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
183913|NCT01626690|B3|Baseline|Total|Total of all reporting groups
183914|NCT01626690|B2|Baseline|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
183915|NCT01626690|B1|Baseline|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
183916|NCT01626690|P2|Participant Flow|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
183917|NCT01626690|P1|Participant Flow|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
183918|NCT01626690|O2|Outcome|SpotOn (3M) Temperature Readings.|Patient temperature at time of incision as measured by SpotOn (3M) temperature monitoring system.
183919|NCT01626690|O1|Outcome|Temporal Artery Thermometer|Patient temperature at time of incision as measured by temporal artery thermometer.
183920|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
183921|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
183922|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
183923|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
183924|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
183925|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
183926|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
183927|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
183928|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
183929|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
183930|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
183931|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
183932|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
183933|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
183934|NCT01626690|E2|Reported Event|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
183935|NCT01626690|E1|Reported Event|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
183936|NCT01626456|B3|Baseline|Total|Total of all reporting groups
183937|NCT01626456|B2|Baseline|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
183938|NCT01626456|B1|Baseline|ALKS 9072, Low|ALKS 9072, Low: IM injection, given monthly
183939|NCT01626456|P2|Participant Flow|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
183940|NCT01626456|P1|Participant Flow|ALKS 9072, Low|ALKS 9072, Low: IM injection, given monthly
183941|NCT01626456|O5|Outcome|De Novo|Subjects who did not participate in the base study. These subjects received high dose.
183942|NCT01626456|O4|Outcome|882-882 mg|Subjects who received high dose in both the base study and the current study.
183943|NCT01626456|O3|Outcome|PBO-882 mg|Subjects who received placebo in the base study and high dose in the current study.
183944|NCT01626456|O2|Outcome|441-441 mg|Subjects who received low dose in both the base study and the current study.
183945|NCT01626456|O1|Outcome|PBO-441 mg|Subjects who received placebo in the base study and low dose in the current study.
183946|NCT01626456|O5|Outcome|De Novo|Subjects who did not participate in the base study. These subjects received high dose.
183947|NCT01626456|O4|Outcome|882-882 mg|Subjects who received high dose in both the base study and the current study.
183948|NCT01626456|O3|Outcome|PBO-882 mg|Subjects who received placebo in the base study and high dose in the current study.
183949|NCT01626456|O2|Outcome|441-441 mg|Subjects who received low dose in both the base study and the current study.
183950|NCT01626456|O1|Outcome|PBO-441 mg|Subjects who received placebo in the base study and low dose in the current study.
183951|NCT01626456|O5|Outcome|De Novo|Subjects who did not participate in the base study.
183952|NCT01626456|O4|Outcome|882-882 mg|Subjects who received high dose in the base study and the current study.
183953|NCT01626456|O3|Outcome|PBO-882 mg|Subjects who received placebo in the base study and high dose in the current study.
183954|NCT01626456|O2|Outcome|441-441 mg|Subjects who received low dose in the base study and in the current study.
183955|NCT01626456|O1|Outcome|PBO-440 mg|Subjects who received placebo in the base study and low dose in the current study
183956|NCT01626456|O2|Outcome|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
183957|NCT01626456|O1|Outcome|ALKS 9072, Low|ALKS 9072, Low: IM injection, given monthly
183958|NCT01626456|O5|Outcome|De Novo|Subjects who did not participate in the base study. These subjects received high dose.
183959|NCT01626456|O4|Outcome|882-882 mg|Subjects who received high dose in both the base study and the current study.
183960|NCT01626456|O3|Outcome|PBO-882 mg|Subjects who received placebo in the base study and high dose in the current study.
183961|NCT01626456|O2|Outcome|441-441 mg|Subjects who received low dose in both the base study and the current study.
183962|NCT01626456|O1|Outcome|PBO-441 mg|Subjects who received placebo in the base study and low dose in the current study.
183963|NCT01626456|O2|Outcome|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
183964|NCT01626456|O1|Outcome|ALKS 9072, Low|ALKS 9072, Low: IM injection, given monthly
183965|NCT01626456|E2|Reported Event|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
183966|NCT01626456|E1|Reported Event|ALKS 9072, Low|ALKS 9072, Low: IM injection, given monthly
183967|NCT01626391|B3|Baseline|Total|Total of all reporting groups
183968|NCT01626391|B2|Baseline|Placebo|One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
183969|NCT01626391|B1|Baseline|TRx0237|One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237)
183970|NCT01626391|P2|Participant Flow|Placebo|One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
183971|NCT01626391|P1|Participant Flow|TRx0237|One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237)
183972|NCT01626391|O2|Outcome|Placebo|One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
183973|NCT01626391|O1|Outcome|TRx0237|One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237)
183974|NCT01626391|E2|Reported Event|Placebo|One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
183975|NCT01626391|E1|Reported Event|TRx0237|One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237)
183976|NCT01626352|B1|Baseline|Bendamustine/Ofatumumab|"All patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6 cycles (a cycle is defined as 21 days in length).~Bendamustine: via IV infusion, 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 Ofatumumab: via IV infusion, 1000-mg IV Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2 through 6"
184013|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
183977|NCT01626352|P1|Participant Flow|Bendamustine/Ofatumumab|"All patients will receive ofatumumab and bendamustine as an intravenous (IV) infusion for 6 cycles (a cycle is defined as 21 days in length).~Bendamustine: via IV infusion, 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 Ofatumumab: via IV infusion, 1000-mg Days 1 and 8 during Cycle 1 only, and on Day 1 of Cycles 2 through 6"
183978|NCT01626352|O1|Outcome|Bendamustine/Ofatumumab|"All patients will receive ofatumumab and bendamustine as an intravenous (IV) infusion for 6 cycles (a cycle is defined as 21 days in length).~Bendamustine: via IV infusion, 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 Ofatumumab: via IV infusion, 1000-mg Days 1 and 8 during Cycle 1 only, and on Day 1 of Cycles 2 through 6"
183979|NCT01626352|O1|Outcome|Bendamustine/Ofatumumab|"All patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6 cycles (a cycle is defined as 21 days in length). Patients will receive as an IV infusion of bendamustine Days 1 and 2 of Cycles 1-6, ofatumumab Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2-6 (see Figure 1).~Bendamustine: Patients will receive as an IV infusion bendamustine 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 and ofatumumab 1000-mg IV Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2 through 6(a cycle is defined as 21 days in length).~Ofatumumab: Patients will receive as an IV infusion bendamustine 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 and ofatumumab 1000-mg IV Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2 through 6(a cycle is defined as 21 days in length)."
183980|NCT01626352|O1|Outcome|Bendamustine/Ofatumumab|"All patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6 cycles (a cycle is defined as 21 days in length). Patients will receive as an IV infusion of bendamustine Days 1 and 2 of Cycles 1-6, ofatumumab Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2-6.~Bendamustine: Patients will receive as an IV infusion bendamustine 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6.~Ofatumumab: Patients will receive as an IV infusion ofatumumab 1000-mg IV Days 1 and 8 during Cycle 1 only, and on Day 1 of Cycles 2 through 6"
183981|NCT01626352|O1|Outcome|Bendamustine/Ofatumumab|"All patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6 cycles (a cycle is defined as 21 days in length).~Bendamustine: via IV infusion, 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 Ofatumumab: via IV infusion, 1000-mg IV Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2 through 6"
183982|NCT01626352|O1|Outcome|Bendamustine/Ofatumumab|"All patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6 cycles (a cycle is defined as 21 days in length).~Bendamustine: via IV infusion, 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 Ofatumumab: via IV infusion, 1000-mg IV Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2 through 6"
183983|NCT01626352|O1|Outcome|Bendamustine/Ofatumumab|"All patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6 cycles (a cycle is defined as 21 days in length). Patients will receive as an IV infusion of bendamustine Days 1 and 2 of Cycles 1-6, ofatumumab Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2-6.~Bendamustine: Patients will receive as an IV infusion bendamustine 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6.~Ofatumumab: Patients will receive as an IV infusion ofatumumab 1000-mg IV Days 1 and 8 during Cycle 1 only, and on Day 1 of Cycles 2 through 6"
183984|NCT01626352|O1|Outcome|Bendamustine/Ofatumumab|"All patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6 cycles (a cycle is defined as 21 days in length).~Bendamustine: via IV infusion, 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 Ofatumumab: via IV infusion, 1000-mg IV Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2 through 6"
183985|NCT01626352|E1|Reported Event|Bendamustine/Ofatumumab|"All patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6 cycles (a cycle is defined as 21 days in length). Patients will receive as an IV infusion of bendamustine Days 1 and 2 of Cycles 1-6, ofatumumab Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2-6 (see Figure 1).~Bendamustine: Patients will receive as an IV infusion bendamustine 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 and ofatumumab 1000-mg IV Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2 through 6(a cycle is defined as 21 days in length).~Ofatumumab: Patients will receive as an IV infusion bendamustine 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 and ofatumumab 1000-mg IV Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2 through 6(a cycle is defined as 21 days in length)."
183986|NCT01626118|B5|Baseline|Total|Total of all reporting groups
183987|NCT01626118|B4|Baseline|Placebo|Placebo Group
183988|NCT01626118|B3|Baseline|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
183989|NCT01626118|B2|Baseline|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
183990|NCT01626118|B1|Baseline|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
183991|NCT01626118|P4|Participant Flow|Placebo|Placebo Group
183992|NCT01626118|P3|Participant Flow|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
183993|NCT01626118|P2|Participant Flow|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
183994|NCT01626118|P1|Participant Flow|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
183995|NCT01626118|O4|Outcome|Placebo|Placebo Group
183996|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
183997|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
183998|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
183999|NCT01626118|O4|Outcome|Placebo|Placebo Group
184000|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
184001|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
184002|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
184003|NCT01626118|O4|Outcome|Placebo|Placebo Group
184004|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
184005|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
184006|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
184007|NCT01626118|O4|Outcome|Placebo|Placebo Group
184008|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
184009|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
184010|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
184014|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
184015|NCT01626118|O4|Outcome|Placebo|Placebo Group
184016|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
184017|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
184018|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
184019|NCT01626118|O4|Outcome|Placebo|Placebo Group
184020|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
184021|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
184022|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
184023|NCT01626118|O4|Outcome|Placebo|Placebo Group
184024|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
184025|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
184026|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
184027|NCT01626118|E4|Reported Event|Placebo|Placebo Group
184028|NCT01626118|E3|Reported Event|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
184029|NCT01626118|E2|Reported Event|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
184030|NCT01626118|E1|Reported Event|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
184031|NCT01626092|B1|Baseline|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.~Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8~Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9"
184032|NCT01626092|P1|Participant Flow|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.~Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8.~Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9,"
184033|NCT01626092|O1|Outcome|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.~Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8.~Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9,"
184034|NCT01626092|O1|Outcome|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.~Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8.~Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9,"
184035|NCT01626092|O1|Outcome|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.~Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8.~Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9,"
184054|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
194298|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
184036|NCT01626092|E1|Reported Event|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.~Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8~Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9"
184037|NCT01625910|B3|Baseline|Total|Total of all reporting groups
184038|NCT01625910|B2|Baseline|Control|On the day of enrollment, after randomization to the control/usual care group, the RA provided age- and ability-appropriate informational hand-outs on school readiness and/or performance.
184039|NCT01625910|B1|Baseline|Intervention - Behavioral Counseling|"The intervention group received management patterned after the Prevention plus, Stage 1 treatment recommended by the expert panel and approved by the committee. Counseling was primarily directed toward the parents. The RA used motivational interviewing (MI) techniques as an entry way to discuss healthy lifestyle habits around eating and physical activity (e.g., open-ended questions, reflective listening, discrepancy questions, eliciting change talk). Evidence-based recommendations for childhood obesity treatment were discussed with the parent; such as, eating breakfast daily, eating ≥ 5 servings of fruits and vegetables/day, avoidance of skipping meals, watching ≤ 2 hours of screen time/day, minimizing or eliminating sugar-sweetened beverages, encouraging family meals at home, and being physically active ≥ 1 hour/day.~There were monthly follow-up phone calls to try and encourage continued success in healthy lifestyle choices."
184040|NCT01625910|P2|Participant Flow|Control|On the day of enrollment, after randomization to the control/usual care group, the RA provided age- and ability-appropriate informational hand-outs on school readiness and/or performance.
184041|NCT01625910|P1|Participant Flow|Intervention - Behavioral Counseling|The intervention group received management patterned after the
184042|NCT01625910|O2|Outcome|Control|Change in cans of sugar sweetened beverages per day
184043|NCT01625910|O1|Outcome|Intervention Group|"The survey done at baseline and follow-up asked about daily cans of sugar-sweetened beverages.~Estimate is for Change in cans of sugar sweetened beverages per day"
184044|NCT01625910|O2|Outcome|Control|On the day of enrollment, after randomization to the control/usual care group, the RA provided age- and ability-appropriate informational hand-outs on school readiness and/or performance.
184045|NCT01625910|O1|Outcome|Intervention - Behavioral Counseling|The intervention group received management patterned after the
184046|NCT01625910|E2|Reported Event|Control|On the day of enrollment, after randomization to the control/usual care group, the RA provided age- and ability-appropriate informational hand-outs on school readiness and/or performance.
184047|NCT01625910|E1|Reported Event|Intervention - Behavioral Counseling|"The intervention group received management patterned after the Prevention plus, Stage 1 treatment recommended by the expert panel and approved by the committee. Counseling was primarily directed toward the parents. The RA used motivational interviewing (MI) techniques as an entry way to discuss healthy lifestyle habits around eating and physical activity (e.g., open-ended questions, reflective listening, discrepancy questions, eliciting change talk). Evidence-based recommendations for childhood obesity treatment were discussed with the parent; such as, eating breakfast daily, eating ≥ 5 servings of fruits and vegetables/day, avoidance of skipping meals, watching ≤ 2 hours of screen time/day, minimizing or eliminating sugar-sweetened beverages, encouraging family meals at home, and being physically active ≥ 1 hour/day.~There were monthly follow-up phone calls to try and encourage continued success in healthy lifestyle choices."
184048|NCT01625845|B3|Baseline|Total|Total of all reporting groups
184049|NCT01625845|B2|Baseline|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
184050|NCT01625845|B1|Baseline|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
184051|NCT01625845|P2|Participant Flow|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
184052|NCT01625845|P1|Participant Flow|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
184053|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
184106|NCT01625416|B3|Baseline|Total|Total of all reporting groups
194299|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
184055|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
184056|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
184057|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
184058|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
184059|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
184060|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
184061|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
184062|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
184063|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
184064|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
184065|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
184066|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
184067|NCT01625845|E2|Reported Event|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
184068|NCT01625845|E1|Reported Event|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
184069|NCT01625689|B3|Baseline|Total|Total of all reporting groups
184070|NCT01625689|B2|Baseline|Placebo|Inactive placebo was identical to the SIIL LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
184071|NCT01625689|B1|Baseline|SIIL LAIV|The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
184072|NCT01625689|P2|Participant Flow|Placebo|Inactive placebo was identical to SIIL LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
184073|NCT01625689|P1|Participant Flow|Serum Institute of India, Ltd. (SIIL) LAIV|The Serum Institute of India, Ltd. (SIIL) live attenuated influenza vaccine (LAIV) (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
184074|NCT01625689|O2|Outcome|Placebo|Inactive placebo was identical to SII LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
184075|NCT01625689|O1|Outcome|SIIL LAIV|The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
184076|NCT01625689|O2|Outcome|Placebo|Inactive placebo was identical to SII LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
184077|NCT01625689|O1|Outcome|SIIL LAIV|The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
184078|NCT01625689|O2|Outcome|Placebo|Inactive placebo was identical to SII LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
184079|NCT01625689|O1|Outcome|SIIL LAIV|The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
184080|NCT01625689|E2|Reported Event|Placebo|Inactive placebo was identical to SII LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
184081|NCT01625689|E1|Reported Event|SIIL LAIV|The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
184082|NCT01625507|B1|Baseline|PANDA Intervention|"12 week nutritional intervention, including 6 classroom/community sessions, plus two sample collection visits.~PANDA intervention: Participants will follow a menu plan and receive training in how to manage their diet in type 2 diabetes, following the recommendations of the Canadian Diabetes Association, 2008"
184083|NCT01625507|P1|Participant Flow|PANDA Intervention|"12 week nutritional intervention, including 6 classroom/community sessions, plus two sample collection visits.~PANDA intervention: Participants will follow a menu plan and receive training in how to manage their diet in type 2 diabetes (T2D), following the recommendations of the Canadian Diabetes Association, 2008"
184084|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
184085|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
184086|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
184087|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
184088|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
184089|NCT01625507|O1|Outcome|PANDA Intervention|"12 week nutritional intervention, including 6 classroom/community sessions, plus two sample collection visits.~PANDA intervention: Participants will follow a menu plan and receive training in how to manage their diet in type 2 diabetes (T2D), following the recommendations of the Canadian Diabetes Association, 2008"
184090|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
184091|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
184092|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
184093|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
184094|NCT01625507|E1|Reported Event|All Participants|T2D diabetes patients
184095|NCT01625455|B3|Baseline|Total|Total of all reporting groups
184096|NCT01625455|B2|Baseline|Aprepitant Then Placebo.|These subjects received aprepitant during the first week and then crossed over to placebo for the second week.
184097|NCT01625455|B1|Baseline|Placebo Then Aprepitant|These subjects received placebo during the first week and then crossed over to aprepitant for the second week.
184098|NCT01625455|P2|Participant Flow|Aprepitant Then Placebo.|These subjects received aprepitant during the first week and then crossed over to placebo for the second week.
184099|NCT01625455|P1|Participant Flow|Placebo Then Aprepitant|These subjects received placebo during the first week and then crossed over to aprepitant for the second week.
184100|NCT01625455|O2|Outcome|Placebo|"Matching placebo will be given in place of aprepitant~Placebo: Placebo will be given orally for a total of 7 days."
184101|NCT01625455|O1|Outcome|Aprepitant|"Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days.~Aprepitant: Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days."
184102|NCT01625455|O2|Outcome|Placebo|"Matching placebo will be given in place of aprepitant~Placebo: Placebo will be given orally for a total of 7 days."
184103|NCT01625455|O1|Outcome|Aprepitant|"Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days.~Aprepitant: Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days."
184104|NCT01625455|E2|Reported Event|Aprepitant|
184105|NCT01625455|E1|Reported Event|Placebo|
184107|NCT01625416|B2|Baseline|Usual Care|Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
184108|NCT01625416|B1|Baseline|Stepped Care Management|Case management, information technology/mHealth innovations, psychotherapy, and psychopharmacology.: All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the three month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-months.
184109|NCT01625416|P2|Participant Flow|Usual Care|Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
184110|NCT01625416|P1|Participant Flow|Stepped Care Management|Case management, information technology/mHealth innovations, psychotherapy, and psychopharmacology.: All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the three month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-months.
184111|NCT01625416|O2|Outcome|Usual Care|Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
184112|NCT01625416|O1|Outcome|Stepped Care Management|All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the 3-6 month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-6 months.
184113|NCT01625416|O2|Outcome|Usual Care|Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
184114|NCT01625416|O1|Outcome|Stepped Care Management|All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the 3-6 month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-6 months.
184115|NCT01625416|O2|Outcome|Usual Care|Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
184116|NCT01625416|O1|Outcome|Stepped Care Management|Case management, information technology/mHealth innovations, psychotherapy, and psychopharmacology.: All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the three month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-months.
184117|NCT01625416|O2|Outcome|Usual Care|Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
184118|NCT01625416|O1|Outcome|Stepped Care Management|Case management, information technology/mHealth innovations, psychotherapy, and psychopharmacology.: All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the three month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-months.
184119|NCT01625416|O2|Outcome|Usual Care|Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
184120|NCT01625416|O1|Outcome|Stepped Care Management|All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the 3-6 month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-6 months.
184121|NCT01625416|O2|Outcome|Usual Care|Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
184137|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
194300|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
184122|NCT01625416|O1|Outcome|Stepped Care Management|All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the 3-6 month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-6 months.
184123|NCT01625416|E2|Reported Event|Usual Care|Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
184124|NCT01625416|E1|Reported Event|Stepped Care Management|Case management, information technology/mHealth innovations, psychotherapy, and psychopharmacology.: All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the three month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-months.
184125|NCT01625377|B3|Baseline|Total|Total of all reporting groups
184126|NCT01625377|B2|Baseline|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
184127|NCT01625377|B1|Baseline|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
184128|NCT01625377|P2|Participant Flow|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
184129|NCT01625377|P1|Participant Flow|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
184130|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
184131|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
184132|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
184133|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
184134|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
184135|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
184136|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
185655|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
184138|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
184139|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
184140|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
184141|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
184142|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
184143|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
184144|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
184145|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
184146|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
184147|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
184148|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
184149|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
184150|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
184151|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
184152|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
184153|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
184154|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
184155|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
184156|NCT01625377|E2|Reported Event|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
184157|NCT01625377|E1|Reported Event|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
184158|NCT01625338|B4|Baseline|Total|Total of all reporting groups
184159|NCT01625338|B3|Baseline|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
184160|NCT01625338|B2|Baseline|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
184161|NCT01625338|B1|Baseline|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
184162|NCT01625338|P3|Participant Flow|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly for 12 weeks in participants
184163|NCT01625338|P2|Participant Flow|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
184164|NCT01625338|P1|Participant Flow|SOF+RBV 12 Weeks|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
184165|NCT01625338|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
184166|NCT01625338|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
184167|NCT01625338|O1|Outcome|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
184168|NCT01625338|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
184169|NCT01625338|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
184170|NCT01625338|O1|Outcome|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
184171|NCT01625338|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
184172|NCT01625338|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
184173|NCT01625338|O1|Outcome|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
184174|NCT01625338|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
184175|NCT01625338|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
184176|NCT01625338|O1|Outcome|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
184177|NCT01625338|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
184178|NCT01625338|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
184179|NCT01625338|O1|Outcome|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
184180|NCT01625338|E3|Reported Event|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
184181|NCT01625338|E2|Reported Event|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
184182|NCT01625338|E1|Reported Event|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
184212|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
184213|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
184183|NCT01625221|B1|Baseline|Magnetic Anal Sphincter Augmentation|"The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.~Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision."
184184|NCT01625221|P1|Participant Flow|Magnetic Anal Sphincter Augmentation|"The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.~Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision."
184185|NCT01625221|O1|Outcome|Magnetic Anal Sphincter Augmentation|"The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.~Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision."
184186|NCT01625221|O1|Outcome|Magnetic Anal Sphincter Augmentation|"The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.~Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision."
184187|NCT01625221|E1|Reported Event|Magnetic Anal Sphincter Augmentation|"The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.~Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision."
184188|NCT01625182|B3|Baseline|Total|Total of all reporting groups
184189|NCT01625182|B2|Baseline|Placebo|Participants received matching placebo to Fingolimod orally once daily.
184190|NCT01625182|B1|Baseline|Fingolimod (FTY720)|Participants received Fingolimod 0.5 mg orally once daily.
184191|NCT01625182|P2|Participant Flow|Placebo|Participants received matching placebo to Fingolimod orally once daily.
184192|NCT01625182|P1|Participant Flow|Fingolimod (FTY720)|Participants received Fingolimod 0.5 mg orally once daily.
184193|NCT01625182|O2|Outcome|Placebo|Participants received matching placebo to Fingolimod orally once daily.
184194|NCT01625182|O1|Outcome|Fingolimod (FTY720)|Participants received Fingolimod 0.5 mg orally once daily.
184195|NCT01625182|O2|Outcome|Placebo|Participants received matching placebo to Fingolimod orally once daily.
184196|NCT01625182|O1|Outcome|Fingolimod (FTY720)|Participants received Fingolimod 0.5 mg orally once daily.
184197|NCT01625182|O2|Outcome|Placebo|Participants received matching placebo to Fingolimod orally once daily.
184198|NCT01625182|O1|Outcome|Fingolimod (FTY720)|Participants received Fingolimod 0.5 mg orally once daily.
184199|NCT01625182|O2|Outcome|Placebo|Participants received matching placebo to Fingolimod orally once daily.
184200|NCT01625182|O1|Outcome|Fingolimod (FTY720)|Participants received Fingolimod 0.5 mg orally once daily.
184201|NCT01625182|E3|Reported Event|Overall Participants|
184202|NCT01625182|E2|Reported Event|Placebo|Participants received matching placebo to Fingolimod orally once daily.
184203|NCT01625182|E1|Reported Event|Fingolimod (FTY720)|Participants received Fingolimod 0.5 mg orally once daily.
184204|NCT01625169|B1|Baseline|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14.~There is only one arm- all pregnant women enrolled into the study will receive Etravirine 200mg PO bid for 14 days postpartum"
184205|NCT01625169|P1|Participant Flow|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
184206|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
184207|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
184208|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
184209|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
184210|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
184211|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
185780|NCT01617187|B4|Baseline|Placebo BID|Participants were administered placebo tablets BID for 42 days
184214|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
184215|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
184216|NCT01625169|E1|Reported Event|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
184217|NCT01625104|B3|Baseline|Total|Total of all reporting groups
184218|NCT01625104|B2|Baseline|Group 2: Control Strategy|"Hospitals randomized to the control group were instructed to conduct business as usual.~Business as usual was described as site specific protocol for treatment of STEMI patient +/- any ongoing quality improvement efforts. No specific recommendations were given to sites from the coordinating center."
184219|NCT01625104|B1|Baseline|Group 1: Agressive Intervention|"Hospitals were randomized to an aggressive intervention strategy or to business as usual. The hospitals randomized to the aggressive intervention strategy underwent the following:~Grand Rounds conducted by physician and nurse from the Coordinating Center. This included a formal presentation on the evidence supporting rapid time to treatment in STEMI patients and evidence based strategies for reducing treatment delays.~Discussion with staff regarding perceived barriers to treatment and suggestions/ideas for strategies to overcome these barriers~Follow-up monthly phone conferences to continue to discuss strategies and ideas sharing~Written plan from sites detailing plans to change processes of care."
184220|NCT01625104|P2|Participant Flow|Group 2: Control|"Hospitals randomized to the control group were instructed to conduct business as usual."
184221|NCT01625104|P1|Participant Flow|Group 1: Agressive Strategy|"Hospitals were randomized to an aggressive intervention strategy or to business as usual. The hospitals randomized to the aggressive intervention strategy underwent the following:~Grand Rounds conducted by physician and nurse from the Coordinating Center. This included a formal presentation on the evidence supporting rapid time to treatment in STEMI patients and evidence based strategies for reducing treatment delays.~Discussion with staff regarding perceived barriers to treatment and suggestions/ideas for strategies to overcome these barriers~Follow-up monthly phone conferences to continue to discuss strategies and ideas sharing~Written plan from sites detailing plans to change processes of care."
184222|NCT01625104|O2|Outcome|Group 2: Control Strategy|"Hospitals randomized to the control group were instructed to conduct business as usual."
184223|NCT01625104|O1|Outcome|Group 1: Aggressive Stategy|
184224|NCT01625104|E2|Reported Event|Group 2: Control Strategy|"Hospitals randomized to the control group were instructed to conduct business as usual.~Business as usual was defined as normal protocol for treatment of STEMI patients at each individual site +/- quality improvement efforts. No contact or advice was given to the sites from the coordinating center."
184225|NCT01625104|E1|Reported Event|Group 1: Agressive Intervention|"Hospitals were randomized to an aggressive intervention strategy or to business as usual. The hospitals randomized to the aggressive intervention strategy underwent the following:~Grand Rounds conducted by physician and nurse from the Coordinating Center. This included a formal presentation on the evidence supporting rapid time to treatment in STEMI patients and evidence based strategies for reducing treatment delays.~Discussion with staff regarding perceived barriers to treatment and suggestions/ideas for strategies to overcome these barriers~Follow-up monthly phone conferences to continue to discuss strategies and ideas sharing~Written plan from sites detailing plans to change processes of care."
184226|NCT01625091|B3|Baseline|Total|Total of all reporting groups
184227|NCT01625091|B2|Baseline|Placebo|The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
184228|NCT01625091|B1|Baseline|Naltrexone|The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
184229|NCT01625091|P2|Participant Flow|Placebo|The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
184230|NCT01625091|P1|Participant Flow|Naltrexone|The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
184231|NCT01625091|O2|Outcome|Placebo|The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
184232|NCT01625091|O1|Outcome|Naltrexone|The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
184233|NCT01625091|O2|Outcome|Placebo|The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
184234|NCT01625091|O1|Outcome|Naltrexone|The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
184235|NCT01625091|O2|Outcome|Placebo|The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
184236|NCT01625091|O1|Outcome|Naltrexone|The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
184237|NCT01625091|O2|Outcome|Placebo|The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
184238|NCT01625091|O1|Outcome|Naltrexone|The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
184239|NCT01625091|E2|Reported Event|Placebo|The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
184240|NCT01625091|E1|Reported Event|Naltrexone|The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
184241|NCT01624948|B3|Baseline|Total|Total of all reporting groups
184242|NCT01624948|B2|Baseline|Standard of Care: 50% Reduction of Mycophenolic Acid (MPA)|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.~Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
184243|NCT01624948|B1|Baseline|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.~Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
184244|NCT01624948|P2|Participant Flow|Standard of Care: 50% Reduction of Mycophenolic Acid (MPA)|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BK polyomavirus (BKV) infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.~Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
184245|NCT01624948|P1|Participant Flow|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo mycophenolic acid (MPA) discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.~Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
184246|NCT01624948|O2|Outcome|No Rejection|No biopsy-proven rejection episode
184247|NCT01624948|O1|Outcome|Rejection|Any biopsy-proven rejection episode
184248|NCT01624948|O2|Outcome|Standard of Care: 50% Reduction of MPA|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.~Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
184249|NCT01624948|O1|Outcome|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.~Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
184250|NCT01624948|O2|Outcome|Standard of Care: 50% Reduction of MPA|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.~Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
184251|NCT01624948|O1|Outcome|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.~Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
184252|NCT01624948|O2|Outcome|Failed to Reach Primary Endpoint|
184253|NCT01624948|O1|Outcome|Reached Primary Endpoint|>50% reduction of BKV viruria and/or clearance of BKV viremia
184254|NCT01624948|O2|Outcome|Standard of Care: 50% Reduction of MPA|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.~Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
184470|NCT01623466|O2|Outcome|AG890-12.5|"Evaluate levonorgestrel delivery in AG890-12.5~levonorgestrel: transdermal contraceptive delivery system"
184255|NCT01624948|O1|Outcome|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.~Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
184256|NCT01624948|O2|Outcome|Standard of Care: 50% Reduction of MPA|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.~Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
184257|NCT01624948|O1|Outcome|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.~Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
184258|NCT01624948|E2|Reported Event|Standard of Care: 50% Reduction of MPA|Mycophenolic acid dose reduction: continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels re-checked. Renal allograft biopsies will be done for cause as clinically indicated.
184259|NCT01624948|E1|Reported Event|Everolimus+Tacrolimus/Prednisone|Everolimus: MPA discontinuation with the addition of Zortress (everolimus) to current regimen of tacrolimus and prednisone; Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
184260|NCT01624740|B3|Baseline|Total|Total of all reporting groups
184261|NCT01624740|B2|Baseline|High Rate Followed By Low Rate|Precision Plus Spinal Cord Stimulation system: The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 1200 Hz stimulation for 3-4 days, followed by 2 Hz stimulation for another 3-4 days.
184262|NCT01624740|B1|Baseline|Low Rate Followed By High Rate|Precision Plus Spinal Cord Stimulation system: The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 2 Hz stimulation for 3-4 days, followed by 1200 Hz stimulation for another 3-4 days.
184263|NCT01624740|P2|Participant Flow|High Rate Followed By Low Rate|The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 1200 Hz stimulation for 3-4 days, followed by 2 Hz stimulation for another 3-4 days.
184264|NCT01624740|P1|Participant Flow|Low Rate Followed By High Rate|The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 2 Hz stimulation for 3-4 days, followed by 1200 Hz stimulation for another 3-4 days.
184265|NCT01624740|O2|Outcome|High Rate Subperception Precision SCS Trial Therapy|Stimulation was given at a rate of 1200 Hz as either a first or second intervention.
184266|NCT01624740|O1|Outcome|Low Rate Subperception Precision SCS Trial Therapy|Stimulation was given at a rate of 2 Hz as either a first or second intervention.
184267|NCT01624740|E3|Reported Event|High Frequency Stimulation|Stimulation was given at 1200 Hz.
184268|NCT01624740|E2|Reported Event|Low Frequency Stimulation|Stimulation was given at 2 Hz.
184269|NCT01624740|E1|Reported Event|Trial Lead Insertion|All subjects (n = 20) underwent a lead insertion procedure prior to beginning Period 1 of stimulation. Two of these subjects did not proceed to Period 1 due to insertion difficulties.
184270|NCT01624467|B1|Baseline|Necitumumab|800 mg necitumumab, administered once per week IV
184271|NCT01624467|P1|Participant Flow|Necitumumab|800 milligram (mg) necitumumab, administered once per week as an intravenous infusion (IV)
184272|NCT01624467|O1|Outcome|Necitumumab|800 mg necitumumab, administered once per week IV
184273|NCT01624467|O1|Outcome|Necitumumab|800 mg necitumumab, administered once per week IV
184274|NCT01624467|O2|Outcome|Necitumumab: Cycle 1, Day 36|800 mg necitumumab, administered once per week IV
184275|NCT01624467|O1|Outcome|Necitumumab: Cycle 1, Day 1|800 mg necitumumab, administered once per week IV
184276|NCT01624467|O2|Outcome|Necitumumab: Cycle 1, Day 36|800 mg necitumumab, administered once per week IV
184277|NCT01624467|O1|Outcome|Necitumumab: Cycle 1, Day 1|800 mg necitumumab, administered once per week IV
184278|NCT01624467|O1|Outcome|Necitumumab|800 mg necitumumab, administered once per week IV
184279|NCT01624467|O1|Outcome|Necitumumab|800 mg necitumumab, administered once per week IV
184280|NCT01624467|O1|Outcome|Necitumumab|800 mg necitumumab, administered once per week IV
184281|NCT01624467|O1|Outcome|Necitumumab|800 mg necitumumab, administered once per week IV
184282|NCT01624467|E1|Reported Event|Necitumumab|800 mg necitumumab, administered once per week as an intravenous infusion (IV)
184283|NCT01624363|B1|Baseline|Patients Undergoing EUS|"Patients undergoing EUS for non-pancreatic treatment.~Diagnosis of a previously undetected pancreatic cyst: patients identified to have a pancreatic cyst, will need to be followed via imaging studies."
184284|NCT01624363|P1|Participant Flow|Patients Undergoing EUS|"Patients undergoing EUS for non-pancreatic treatment.~Diagnosis of a previously undetected pancreatic cyst: patients identified to have a pancreatic cyst, will need to be followed via imaging studies."
184285|NCT01624363|O1|Outcome|Patients Undergoing EUS|"Patients undergoing EUS for non-pancreatic treatment.~Diagnosis of a previously undetected pancreatic cyst: patients identified to have a pancreatic cyst, will need to be followed via imaging studies."
184286|NCT01624363|E1|Reported Event|Patients Undergoing EUS|"Patients undergoing EUS for non-pancreatic treatment.~Diagnosis of a previously undetected pancreatic cyst: patients identified to have a pancreatic cyst, will need to be followed via imaging studies."
184287|NCT01624350|B1|Baseline|Permacol Collagen Paste|
184288|NCT01624350|P1|Participant Flow|Permacol Collagen Paste|
184289|NCT01624350|O5|Outcome|Permacol Collagen Paste - 12 Month Post-op|
184290|NCT01624350|O4|Outcome|Permacol Collagen Paste - 6 Month Post-op|
184291|NCT01624350|O3|Outcome|Permacol Collagen Paste - 3 Month Post-op|
184292|NCT01624350|O2|Outcome|Permacol Collagen Paste - 1 Month Post-op|
184293|NCT01624350|O1|Outcome|Baseline|
184294|NCT01624350|O2|Outcome|Last Visit|
184295|NCT01624350|O1|Outcome|First Visit|
184296|NCT01624350|O3|Outcome|Permacol Collagen Paste - 12 Month Post-op|
184297|NCT01624350|O2|Outcome|Permacol Collagen Paste - 6 Month Post-op|
184298|NCT01624350|O1|Outcome|Permacol Collagen Paste - 3 Month Post-op|
184299|NCT01624350|O4|Outcome|Permacol Collagen Paste - 12 Month Post-op|
184300|NCT01624350|O3|Outcome|Permacol Collagen Paste - 6 Month Post-op|
184301|NCT01624350|O2|Outcome|Permacol Collagen Paste - 3 Month Post-op|
184302|NCT01624350|O1|Outcome|Baseline - Pre-operatively|
184303|NCT01624350|O2|Outcome|Permacol Collagen Paste - 12 Month Follow up|
184304|NCT01624350|O1|Outcome|Permacol Collagen Paste - 3 Month Follow up|
184305|NCT01624350|O1|Outcome|Permacol Collagen Paste|
184306|NCT01624350|E1|Reported Event|Permacol Collagen Paste|
184307|NCT01624259|B3|Baseline|Total|Total of all reporting groups
184308|NCT01624259|B2|Baseline|Liraglutide|"Liraglutide 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, oral, for 26 weeks"
184309|NCT01624259|B1|Baseline|LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, oral, for 26 weeks"
184310|NCT01624259|P2|Participant Flow|Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, oral, for 26 weeks"
184311|NCT01624259|P1|Participant Flow|LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 mg/day, oral, for 26 weeks"
184312|NCT01624259|O2|Outcome|Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, oral, for 26 weeks"
184313|NCT01624259|O1|Outcome|LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 mg/day, oral, for 26 weeks"
184314|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184315|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184316|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184317|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184318|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184319|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184320|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184321|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184322|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184323|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184324|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184325|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184326|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184327|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184328|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184329|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184330|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184331|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184332|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184333|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184334|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184335|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184336|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184337|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184338|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184339|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184340|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184341|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184342|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184343|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184344|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184345|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184346|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184347|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184348|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184349|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184350|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184351|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184352|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184353|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184354|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184355|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184356|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184357|NCT01624259|E2|Reported Event|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184358|NCT01624259|E1|Reported Event|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
184398|NCT01624168|O3|Outcome|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
186369|NCT01614457|O2|Outcome|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
184359|NCT01624233|B1|Baseline|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
184360|NCT01624233|P1|Participant Flow|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-milligram (mg) subcutaneous (SC) injections at Week 0, followed by 80 mg given as 1 SC injection every 2 weeks (Q2W) (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection every 4 weeks (Q4W) (Week 12 up to Week 52).~Period 4 - No ixekizumab administered (drug-free). Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80-mg as 1 SC injection Q4W for up to 192 weeks."
184361|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
184362|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
184363|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
184364|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
184365|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
184366|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
184367|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
184368|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
184369|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
184370|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
184371|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
184399|NCT01624168|O2|Outcome|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
184372|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
184373|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
184374|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
184375|NCT01624233|E1|Reported Event|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
184376|NCT01624168|B4|Baseline|Total|Total of all reporting groups
184377|NCT01624168|B3|Baseline|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
184378|NCT01624168|B2|Baseline|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
184379|NCT01624168|B1|Baseline|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
184380|NCT01624168|P3|Participant Flow|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
184381|NCT01624168|P2|Participant Flow|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
184382|NCT01624168|P1|Participant Flow|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
184383|NCT01624168|O3|Outcome|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
184384|NCT01624168|O2|Outcome|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
184385|NCT01624168|O1|Outcome|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
184386|NCT01624168|O3|Outcome|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
184387|NCT01624168|O2|Outcome|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
184388|NCT01624168|O1|Outcome|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
184389|NCT01624168|O3|Outcome|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
184390|NCT01624168|O2|Outcome|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
184391|NCT01624168|O1|Outcome|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
184392|NCT01624168|O3|Outcome|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
184393|NCT01624168|O2|Outcome|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
184394|NCT01624168|O1|Outcome|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
184395|NCT01624168|O3|Outcome|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
184396|NCT01624168|O2|Outcome|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
184397|NCT01624168|O1|Outcome|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
184400|NCT01624168|O1|Outcome|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
194301|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
184401|NCT01624168|E3|Reported Event|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
184402|NCT01624168|E2|Reported Event|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
184403|NCT01624168|E1|Reported Event|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
184404|NCT01623869|B1|Baseline|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
184405|NCT01623869|P1|Participant Flow|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
184406|NCT01623869|O1|Outcome|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
184407|NCT01623869|O1|Outcome|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
184408|NCT01623869|O1|Outcome|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
184409|NCT01623869|E1|Reported Event|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
184410|NCT01623830|B3|Baseline|Total|Total of all reporting groups
184411|NCT01623830|B2|Baseline|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
184412|NCT01623830|B1|Baseline|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
184413|NCT01623830|P2|Participant Flow|Neutral Cue + VRE|"VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.~Virtual Reality Exposure Therapy: Treatment will consist of 8 weekly sessions. Session 1: information gathering, treatment procedures and rationale. Session 2: Cognitive restructuring. Session 3: Breathing retraining and thought stopping. Session 4: Review cognitive restructuring and hyperventilation exposure. Sessions 5-8 Fear of flying exposure in the Virtual environment."
184414|NCT01623830|P1|Participant Flow|Reactivation + VRE|"Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.~Virtual Reality Exposure Therapy: Treatment will consist of 8 weekly sessions. Session 1: information gathering, treatment procedures and rationale. Session 2: Cognitive restructuring. Session 3: Breathing retraining and thought stopping. Session 4: Review cognitive restructuring and hyperventilation exposure. Sessions 5-8 Fear of flying exposure in the Virtual environment."
184415|NCT01623830|O2|Outcome|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
184416|NCT01623830|O1|Outcome|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
184417|NCT01623830|O2|Outcome|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
184418|NCT01623830|O1|Outcome|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
184419|NCT01623830|O2|Outcome|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
184420|NCT01623830|O1|Outcome|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
184421|NCT01623830|O2|Outcome|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
184422|NCT01623830|O1|Outcome|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
184423|NCT01623830|O2|Outcome|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
184424|NCT01623830|O1|Outcome|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
184425|NCT01623830|E2|Reported Event|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
184469|NCT01623466|O1|Outcome|AG890-6.5|"Evaluate levonorgestrel delivery in AG890-6.5~levonorgestrel: transdermal contraceptive delivery system"
184426|NCT01623830|E1|Reported Event|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
184427|NCT01623739|B3|Baseline|Total|Total of all reporting groups
184428|NCT01623739|B2|Baseline|Type 2 Implant Placement|"Once the tooth is extracted. The site is left to heal for 4 to 8 weeks before a dental implant is placed during a second surgical procedure.~Placement of a dental implant: Type 1 implant placement Type 2 implant placement"
184429|NCT01623739|B1|Baseline|Type 1 Implant Placement|"Implant is placed immediately following tooth extraction in one surgical procedure~Placement of a dental implant: Type 1 implant placement Type 2 implant placement"
184430|NCT01623739|P2|Participant Flow|Type 2 Implant Placement|"Once the tooth is extracted. The site is left to heal for 4 to 8 weeks before a dental implant is placed during a second surgical procedure.~Placement of a dental implant: Type 1 implant placement Type 2 implant placement"
184431|NCT01623739|P1|Participant Flow|Type 1 Implant Placement|"Implant is placed immediately following tooth extraction in one surgical procedure~Placement of a dental implant: Type 1 implant placement Type 2 implant placement"
184432|NCT01623739|O2|Outcome|Type 2 Implant Placement|"Once the tooth is extracted. The site is left to heal for 4 to 8 weeks before a dental implant is placed during a second surgical procedure.~Placement of a dental implant: Type 1 implant placement Type 2 implant placement"
184433|NCT01623739|O1|Outcome|Type 1 Implant Placement|"Implant is placed immediately following tooth extraction in one surgical procedure~Placement of a dental implant: Type 1 implant placement Type 2 implant placement"
184434|NCT01623739|E2|Reported Event|Type 2 Implant Placement|"Once the tooth is extracted. The site is left to heal for 4 to 8 weeks before a dental implant is placed during a second surgical procedure.~Placement of a dental implant: Type 1 implant placement Type 2 implant placement"
184435|NCT01623739|E1|Reported Event|Type 1 Implant Placement|"Implant is placed immediately following tooth extraction in one surgical procedure~Placement of a dental implant: Type 1 implant placement Type 2 implant placement"
184436|NCT01623596|B3|Baseline|Total|Total of all reporting groups
184437|NCT01623596|B2|Baseline|Disease Modifying Therapy (MS_DMT)|2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
184438|NCT01623596|B1|Baseline|Fingolimod|fingolimod 0.5 mg once a day
184439|NCT01623596|P2|Participant Flow|Disease Modifying Therapy|2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
184440|NCT01623596|P1|Participant Flow|Fingolimod|fingolimod 0.5 mg once a day
184441|NCT01623596|O2|Outcome|Disease Modifying Therapy (DS-DMT)|2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
184442|NCT01623596|O1|Outcome|Fingolimod|fingolimod 0.5 mg once a day
184443|NCT01623596|O2|Outcome|Disease Modifying Therapy|2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
184444|NCT01623596|O1|Outcome|Fingolimod|fingolimod 0.5 mg once a day
184445|NCT01623596|O2|Outcome|Disease Modifying Therapy (MS-DMT)|2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
184446|NCT01623596|O1|Outcome|Fingolimod|fingolimod 0.5 mg once a day
184447|NCT01623596|O2|Outcome|Disease Modifying Therapy (MS-DMT)|2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
184448|NCT01623596|O1|Outcome|Fingolimod|fingolimod 0.5 mg once a day
184449|NCT01623596|O2|Outcome|Disease Modifying Therapy (MS-DMT)|2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
184450|NCT01623596|O1|Outcome|Fingolimod|fingolimod 0.5 mg once a day
184451|NCT01623596|O2|Outcome|Disease Modifying Therapy (MS-DMT)|2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
184452|NCT01623596|O1|Outcome|Fingolimod|fingolimod 0.5 mg once a day
184453|NCT01623596|E2|Reported Event|MS DMT|MS DMT
184454|NCT01623596|E1|Reported Event|Fingolimod|Fingolimod
184455|NCT01623479|B1|Baseline|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
184456|NCT01623479|P1|Participant Flow|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
184457|NCT01623479|O1|Outcome|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
184458|NCT01623479|O1|Outcome|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
184459|NCT01623479|O1|Outcome|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
184460|NCT01623479|E1|Reported Event|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
184461|NCT01623466|B3|Baseline|Total|Total of all reporting groups
184462|NCT01623466|B2|Baseline|AG890-12.5|"Evaluate levonorgestrel delivery in AG890-12.5~levonorgestrel: transdermal contraceptive delivery system"
184463|NCT01623466|B1|Baseline|AG890-6.5|"Evaluate levonorgestrel delivery in AG890-6.5~levonorgestrel: transdermal contraceptive delivery system"
184464|NCT01623466|P2|Participant Flow|AG890-12.5|"Evaluate levonorgestrel delivery in AG890-12.5~levonorgestrel: transdermal contraceptive delivery system"
184465|NCT01623466|P1|Participant Flow|AG890-6.5|"Evaluate levonorgestrel delivery in AG890-6.5~levonorgestrel: transdermal contraceptive delivery system"
184466|NCT01623466|O2|Outcome|AG890-12.5|"Evaluate levonorgestrel delivery in AG890-12.5~levonorgestrel: transdermal contraceptive delivery system"
184467|NCT01623466|O1|Outcome|AG890-6.5|"Evaluate levonorgestrel delivery in AG890-6.5~levonorgestrel: transdermal contraceptive delivery system"
184468|NCT01623466|O2|Outcome|AG890-12.5|"Evaluate levonorgestrel delivery in AG890-12.5~levonorgestrel: transdermal contraceptive delivery system"
184471|NCT01623466|O1|Outcome|AG890-6.5|"Evaluate levonorgestrel delivery in AG890-6.5~levonorgestrel: transdermal contraceptive delivery system"
184472|NCT01623466|O2|Outcome|AG890-12.5|"Evaluate levonorgestrel delivery in AG890-12.5~levonorgestrel: transdermal contraceptive delivery system"
184473|NCT01623466|O1|Outcome|AG890-6.5|"Evaluate levonorgestrel delivery in AG890-6.5~levonorgestrel: transdermal contraceptive delivery system"
184474|NCT01623466|O2|Outcome|AG890-12.5|"Evaluate levonorgestrel delivery in AG890-12.5~levonorgestrel: transdermal contraceptive delivery system"
184475|NCT01623466|O1|Outcome|AG890-6.5|"Evaluate levonorgestrel delivery in AG890-6.5~levonorgestrel: transdermal contraceptive delivery system"
184476|NCT01623466|E2|Reported Event|AG890-12.5|"Evaluate levonorgestrel delivery in AG890-12.5~levonorgestrel: transdermal contraceptive delivery system"
184477|NCT01623466|E1|Reported Event|AG890-6.5|"Evaluate levonorgestrel delivery in AG890-6.5~levonorgestrel: transdermal contraceptive delivery system"
184478|NCT01623323|B1|Baseline|OPN-375|OPN-375 400 mcg/twice daily
184479|NCT01623323|P1|Participant Flow|OPN-375|OPN-375 400 mcg/twice daily
184480|NCT01623323|O1|Outcome|OPN-375|OPN-375 400 mcg/twice daily
184481|NCT01623323|E1|Reported Event|OPN-375|OPN-375 400 mcg/twice daily
184482|NCT01623310|B1|Baseline|OPN-375 400 μg|OPN-375 400 μg BID for 12 months
184483|NCT01623310|P1|Participant Flow|OPN-375 400 μg|OPN-375 400 μg BID for 12 months
184484|NCT01623310|O1|Outcome|OPN-375 400 μg|OPN-375 400 μg BID for 12 months
184485|NCT01623310|O1|Outcome|OPN-375 400 μg|OPN-375 400 μg BID for 12 months
184486|NCT01623310|O1|Outcome|OPN-375 400 μg|OPN-375 400 μg BID for 12 months
184487|NCT01623310|O1|Outcome|OPN-375 400 μg|OPN-375 400 μg BID for 12 months
184488|NCT01623310|O1|Outcome|OPN-375 400 μg|OPN-375 400 μg BID for 12 months
184489|NCT01623310|O1|Outcome|OPN-375 400 μg|OPN-375 400 μg BID for 12 months
184490|NCT01623310|E1|Reported Event|Fluticasone|"400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device~Fluticasone Proprionate using OptiNose Device"
184491|NCT01623271|B1|Baseline|CRPS I Pain Subjects|"This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks.~Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day"
184492|NCT01623271|P1|Participant Flow|CRPS I Pain Subjects|"This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks.~Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day"
184493|NCT01623271|O1|Outcome|CRPS I Pain Subjects|"This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks.~Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day"
184494|NCT01623271|E1|Reported Event|CRPS I Pain Subjects|"This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks.~Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day"
184495|NCT01623154|B1|Baseline|BreathTek UBT|Comparison of urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone and UBiT-IR300. UBiT-IR300 is the FDA approved device.
184496|NCT01623154|P1|Participant Flow|Urea Hydrolysis Rate (UHR)|"Urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone and UBiT -IR300~Same patients will be tested on both the POCone and UBiT-IR300"
184497|NCT01623154|O2|Outcome|POCone|This is the device being tested and compared to the FDA approved device.
184498|NCT01623154|O1|Outcome|UBiT-IR300|This is the FDA approved device.
184499|NCT01623154|O1|Outcome|Urea Hydrolysis Rate (UHR) Values|Urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone compared to the the approved device, UBiT-IR300. Three regression analyses completed (Deming, Passing-Bablok and Regular regression).
184500|NCT01623154|E1|Reported Event|Pranactin Citric Solution|At each visit, each subject provided baseline breath samples by exhaling into the mouthpiece of the 3 Baseline bags (Blue bags, labeled A,B, C according to collection order), received one 4 oz administration of Pranctin Citric solution (mixed in water, drink using a straw), waited 15 minutes and provided the Post-Dose breath samples (Pink bags, labeled A, B, C). The Blue and Pink bags were paired and tested in no particular order on each instrument. The subjects who tested positive for H.pylori underwent a second set of tests 28 days after completion of eradication therapy.
184501|NCT01623115|B3|Baseline|Total|Total of all reporting groups
184502|NCT01623115|B2|Baseline|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184503|NCT01623115|B1|Baseline|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184504|NCT01623115|P2|Participant Flow|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184505|NCT01623115|P1|Participant Flow|Placebo|Placebo for alirocumab subcutaneous (SC) injection every 2 weeks (Q2W) on top of stable lipid-modifying therapy (LMT) for 78 weeks.
184506|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184507|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184508|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184509|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
185656|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184510|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184511|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184512|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184513|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184514|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184515|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184516|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184517|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184518|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184519|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184520|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184521|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184522|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184523|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184524|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184525|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184526|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184527|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184528|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184529|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184530|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184531|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184532|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184533|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184534|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184535|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184536|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184537|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184538|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184539|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184540|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184541|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184542|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184543|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184544|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184545|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184546|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184547|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184614|NCT01622673|E4|Reported Event|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
184548|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184549|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184550|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184551|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184552|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184553|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184554|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184555|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184556|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184557|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184558|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184559|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184560|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
184561|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184562|NCT01623115|E2|Reported Event|Alirocumab 75/Up to 150 mg Q2W|Participants exposed to Alirocumab 75 mg/Up to 150 mg Q2W on top of stable LMT (mean exposure of 72 weeks).
184563|NCT01623115|E1|Reported Event|Placebo|Participants exposed to placebo Q2W on top of stable LMT (mean exposure of 72 weeks).
184564|NCT01623050|B1|Baseline|SinuSys Dilation System|"Maxillary Sinus Dilation~SinuSys Dilation System: Sinuplasty"
184565|NCT01623050|P1|Participant Flow|SinuSys Dilation System|Maxillary Sinus Dilation
184566|NCT01623050|O1|Outcome|SinuSys Dilation System|Maxillary Sinus Dilation
184567|NCT01623050|O1|Outcome|SinuSys Dilation System|Maxillary Sinus Dilation
184568|NCT01623050|O1|Outcome|SinuSys Dilation System|Maxillary Sinus Dilation
184569|NCT01623050|O1|Outcome|SinuSys Dilation System|Maxillary Sinus Dilation
184570|NCT01623050|O1|Outcome|SinuSys Dilation System|Maxillary Sinus Dilation
184571|NCT01623050|E1|Reported Event|SinuSys Dilation System|Maxillary Sinus Dilation
184572|NCT01622673|B7|Baseline|Total|Total of all reporting groups
184573|NCT01622673|B6|Baseline|MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL|Participants received MINTOX® + Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
184574|NCT01622673|B5|Baseline|TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL|Participants received Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
184575|NCT01622673|B4|Baseline|RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL|Participants received MINTOX® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
184576|NCT01622673|B3|Baseline|MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL|Participants received MINTOX® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
184577|NCT01622673|B2|Baseline|TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL|Participants received TUMS® + Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
184578|NCT01622673|B1|Baseline|RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL|Participants received Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a 2-day washout between treatment periods.
184579|NCT01622673|P6|Participant Flow|MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL|Participants received MINTOX® + Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
184615|NCT01622673|E3|Reported Event|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
185657|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
184580|NCT01622673|P5|Participant Flow|TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL|Participants received TUMS® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
184581|NCT01622673|P4|Participant Flow|RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL|Participants received Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
184582|NCT01622673|P3|Participant Flow|MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL|Participants received MINTOX® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
184583|NCT01622673|P2|Participant Flow|TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL|Participants received TUMS® + Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
184584|NCT01622673|P1|Participant Flow|RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL|Participants received Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a 2-day washout between treatment periods.
184585|NCT01622673|O5|Outcome|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of AE assessment
184586|NCT01622673|O4|Outcome|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of AE assessment
184587|NCT01622673|O3|Outcome|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of AE assessment
184588|NCT01622673|O2|Outcome|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of AE assessment
184589|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
184590|NCT01622673|O5|Outcome|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
184591|NCT01622673|O4|Outcome|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
184592|NCT01622673|O3|Outcome|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
184593|NCT01622673|O2|Outcome|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of PK sampling
184594|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
184595|NCT01622673|O3|Outcome|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
184596|NCT01622673|O2|Outcome|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
184597|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
184598|NCT01622673|O3|Outcome|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
184599|NCT01622673|O2|Outcome|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of PK sampling
184600|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
184601|NCT01622673|O3|Outcome|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
184602|NCT01622673|O2|Outcome|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
184603|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
184604|NCT01622673|O3|Outcome|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
184605|NCT01622673|O2|Outcome|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of PK sampling
184606|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
184607|NCT01622673|O3|Outcome|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
184608|NCT01622673|O2|Outcome|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
184609|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
184610|NCT01622673|O3|Outcome|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
184611|NCT01622673|O2|Outcome|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of pharmacokinetic (PK) sampling
184612|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
184613|NCT01622673|E5|Reported Event|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
184616|NCT01622673|E2|Reported Event|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of PK sampling
184617|NCT01622673|E1|Reported Event|Raltegravir|Raltegravir 400 mg every 12 hours
184618|NCT01622660|B1|Baseline|Gemcitabine and Pazopanib|"This is a phase II trial of gemcitabine and pazopanib in previously untreated patients with advanced/metastatic urothelial carcinoma (UC) who are ineligible for cisplatin-based chemotherapy.~Gemcitabine and Pazopanib: Patients will receive gemcitabine 1200 mg/m2 intravenously on day 1 and day 8 and pazopanib 800 mg orally daily day 1 through day 21 (1 cycle = 21 days). Patients will receive 6 cycles of combination therapy (gemcitabine and pazopanib) unless disease progression or unacceptable toxicity occurs. Patients that achieve stable disease, a partial response, or a complete response after completion of 6 cycles, and who are not candidates for consolidation surgery, will be eligible to continue pazopanib monotherapy at the same dose and schedule until disease progression for a maximum of 18 additional cycles."
184619|NCT01622660|P1|Participant Flow|Gemcitabine and Pazopanib|Chemotherapy naïve participants with advanced/metastatic urothelial carcinoma ineligible for Cisplatin-based chemotherapy
184620|NCT01622660|O1|Outcome|Gemcitabine and Pazopanib|"This is a phase II trial of gemcitabine and pazopanib in previously untreated patients with advanced/metastatic urothelial carcinoma (UC) who are ineligible for cisplatin-based chemotherapy.~Gemcitabine and Pazopanib: Patients will receive gemcitabine 1200 mg/m2 intravenously on day 1 and day 8 and pazopanib 800 mg orally daily day 1 through day 21 (1 cycle = 21 days). Patients will receive 6 cycles of combination therapy (gemcitabine and pazopanib) unless disease progression or unacceptable toxicity occurs. Patients that achieve stable disease, a partial response, or a complete response after completion of 6 cycles, and who are not candidates for consolidation surgery, will be eligible to continue pazopanib monotherapy at the same dose and schedule until disease progression for a maximum of 18 additional cycles."
184621|NCT01622660|E1|Reported Event|Gemcitabine and Pazopanib|"This is a phase II trial of gemcitabine and pazopanib in previously untreated patients with advanced/metastatic urothelial carcinoma (UC) who are ineligible for cisplatin-based chemotherapy.~Gemcitabine and Pazopanib: Patients will receive gemcitabine 1200 mg/m2 intravenously on day 1 and day 8 and pazopanib 800 mg orally daily day 1 through day 21 (1 cycle = 21 days). Patients will receive 6 cycles of combination therapy (gemcitabine and pazopanib) unless disease progression or unacceptable toxicity occurs. Patients that achieve stable disease, a partial response, or a complete response after completion of 6 cycles, and who are not candidates for consolidation surgery, will be eligible to continue pazopanib monotherapy at the same dose and schedule until disease progression for a maximum of 18 additional cycles."
184622|NCT01622348|B4|Baseline|Total|Total of all reporting groups
184623|NCT01622348|B3|Baseline|Placebo|"Saline for Injection~Saline for Injection: Saline for Injection 0.01 mL/kg SC q wk x 4 wk based on body weight at screening, not to exceed 1.25 mL"
184624|NCT01622348|B2|Baseline|IMO-3100 at 0.32 mg/kg|"IMO-3100 at 0.32 mg/kg SC q wk x 4 wk based on body weight at screening, not to exceed 40 mg per injection~IMO-3100 at 0.32 mg/kg: IMO-3100 at 0.32 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 40 mg per injection"
184625|NCT01622348|B1|Baseline|IMO-3100 at 0.16 mg/kg|"IMO-3100 at 0.16 mg/kg SC once weekly based on body weight at screening, not to exceed 20 mg per injection~IMO-3100 at 0.16 mg/kg: IMO-3100 at 0.16 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 20 mg per injection"
184626|NCT01622348|P3|Participant Flow|Placebo|"Saline for Injection~Saline for Injection: Saline for Injection 0.01 mL/kg SC q wk x 4 wk based on body weight at screening, not to exceed 1.25 mL"
184627|NCT01622348|P2|Participant Flow|IMO-3100 at 0.32 mg/kg|"IMO-3100 at 0.32 mg/kg SC q wk x 4 wk based on body weight at screening, not to exceed 40 mg per injection~IMO-3100 at 0.32 mg/kg: IMO-3100 at 0.32 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 40 mg per injection"
184628|NCT01622348|P1|Participant Flow|IMO-3100 at 0.16 mg/kg|"IMO-3100 at 0.16 mg/kg SC once weekly based on body weight at screening, not to exceed 20 mg per injection~IMO-3100 at 0.16 mg/kg: IMO-3100 at 0.16 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 20 mg per injection"
184629|NCT01622348|O3|Outcome|Placebo|"Saline for Injection~Saline for Injection: Saline for Injection 0.01 mL/kg SC q wk x 4 wk based on body weight at screening, not to exceed 1.25 mL"
184630|NCT01622348|O2|Outcome|IMO-3100 at 0.32 mg/kg|"IMO-3100 at 0.32 mg/kg SC q wk x 4 wk based on body weight at screening, not to exceed 40 mg per injection~IMO-3100 at 0.32 mg/kg: IMO-3100 at 0.32 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 40 mg per injection"
184631|NCT01622348|O1|Outcome|IMO-3100 at 0.16 mg/kg|"IMO-3100 at 0.16 mg/kg SC once weekly based on body weight at screening, not to exceed 20 mg per injection~IMO-3100 at 0.16 mg/kg: IMO-3100 at 0.16 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 20 mg per injection"
184632|NCT01622348|E3|Reported Event|Placebo|"Saline for Injection~Saline for Injection: Saline for Injection 0.01 mL/kg SC q wk x 4 wk based on body weight at screening, not to exceed 1.25 mL"
184633|NCT01622348|E2|Reported Event|IMO-3100 at 0.32 mg/kg|"IMO-3100 at 0.32 mg/kg SC q wk x 4 wk based on body weight at screening, not to exceed 40 mg per injection~IMO-3100 at 0.32 mg/kg: IMO-3100 at 0.32 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 40 mg per injection"
184634|NCT01622348|E1|Reported Event|IMO-3100 at 0.16 mg/kg|"IMO-3100 at 0.16 mg/kg SC once weekly based on body weight at screening, not to exceed 20 mg per injection~IMO-3100 at 0.16 mg/kg: IMO-3100 at 0.16 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 20 mg per injection"
184635|NCT01622296|B1|Baseline|Crossover Lidocaine/Buffered Lidocaine|lidocaine 2% with 1:100,000 epinephrine followed by buffered lidocaine 2% with 1:100,000 epinephrine or buffered lidocaine 2% with 1:100,000 epinephrine followed by lidocaine 2% with 1:100,000 epinephrine
184636|NCT01622296|P2|Participant Flow|Buffered Lidocaine First, Then Lidocaine|buffered lidocaine 2% with 1:100,000 epinephrine followed by lidocaine 2% with 1:100,000 epinephrine. Two treatment visits were required to complete bilateral dental operative restorations. At each visit, local anesthetic was delivered to the right or left side of the dentition using one of the two anesthetic types. The second injection/treatment appointment was at least 1 week after the first treatment.
184679|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
185658|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
184637|NCT01622296|P1|Participant Flow|Lidocaine First, Then Buffered Lidocaine|lidocaine 2% with 1:100,000 epinephrine followed by buffered lidocaine 2% with 1:100,000 epinephrine. Two treatment visits were required to complete bilateral dental operative restorations. At each visit, local anesthetic was delivered to the right or left side of the dentition using one of the two anesthetic types. The second injection/treatment appointment was at least 1 week after the first treatment.
184638|NCT01622296|O2|Outcome|Buffered Lidocaine|2% buffered lidocaine with 1:100,000 ppm epinephrine
184639|NCT01622296|O1|Outcome|Lidocaine|2% lidocaine with 1:100,000 ppm epinephrine
184640|NCT01622296|E1|Reported Event|Crossover Lidocaine/Buffered Lidocaine|lidocaine 2% with 1:100,000 epinephrine followed by buffered lidocaine 2% with 1:100,000 epinephrine or buffered lidocaine 2% with 1:100,000 epinephrine followed by lidocaine 2% with 1:100,000 epinephrine
184641|NCT01622257|B4|Baseline|Total|Total of all reporting groups
184642|NCT01622257|B3|Baseline|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
184643|NCT01622257|B2|Baseline|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
184644|NCT01622257|B1|Baseline|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
184645|NCT01622257|P3|Participant Flow|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
184646|NCT01622257|P2|Participant Flow|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
184647|NCT01622257|P1|Participant Flow|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
184648|NCT01622257|O3|Outcome|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
184649|NCT01622257|O2|Outcome|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
184650|NCT01622257|O1|Outcome|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
184651|NCT01622257|O3|Outcome|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
184652|NCT01622257|O2|Outcome|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
184653|NCT01622257|O1|Outcome|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
184654|NCT01622257|O3|Outcome|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
184655|NCT01622257|O2|Outcome|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
184656|NCT01622257|O1|Outcome|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
184657|NCT01622257|O3|Outcome|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
184658|NCT01622257|O2|Outcome|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
184659|NCT01622257|O1|Outcome|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
184660|NCT01622257|O3|Outcome|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
184661|NCT01622257|O2|Outcome|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
184662|NCT01622257|O1|Outcome|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
184663|NCT01622257|E3|Reported Event|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
184664|NCT01622257|E2|Reported Event|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
184665|NCT01622257|E1|Reported Event|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
184666|NCT01622231|B1|Baseline|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
184667|NCT01622231|P1|Participant Flow|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
184668|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
184669|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
184670|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
184671|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
184672|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
184673|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
184674|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
184675|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
184676|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
184677|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
184678|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
185565|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
184680|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
184681|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
184682|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
184683|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
184684|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
184685|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
184686|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
184687|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
184688|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
184689|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
184690|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
184691|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
184692|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
184693|NCT01622231|E1|Reported Event|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
184694|NCT01621802|B7|Baseline|Total|Total of all reporting groups
184695|NCT01621802|B6|Baseline|Com_MMR_S Group|Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184696|NCT01621802|B5|Baseline|Inv_MMR_S Group|Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
184697|NCT01621802|B4|Baseline|Com_MMR_I Group|Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184698|NCT01621802|B3|Baseline|Inv_MMR_I Group|Subjects received one dose of Priorix at Visit 1 (Day 0).
184699|NCT01621802|B2|Baseline|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184700|NCT01621802|B1|Baseline|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184701|NCT01621802|P6|Participant Flow|Com_MMR_S Group|Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184702|NCT01621802|P5|Participant Flow|Inv_MMR_S Group|Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
184703|NCT01621802|P4|Participant Flow|Com_MMR_I Group|Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184704|NCT01621802|P3|Participant Flow|Inv_MMR_I Group|Subjects received one dose of Priorix at Visit 1 (Day 0).
184705|NCT01621802|P2|Participant Flow|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184706|NCT01621802|P1|Participant Flow|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184707|NCT01621802|O6|Outcome|Com_MMR_S Group|Subjects in this safety cohort received one dose of M-M-RII (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184708|NCT01621802|O5|Outcome|Inv_MMR_S Group|Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
184709|NCT01621802|O4|Outcome|Com_MMR_I Group|Subjects received one dose of M-M-RII (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184710|NCT01621802|O3|Outcome|Inv_MMR_I Group|Subjects received one dose of Priorix at Visit 1 (Day 0).
184711|NCT01621802|O2|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-RII (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184712|NCT01621802|O1|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184713|NCT01621802|O6|Outcome|Com_MMR_S Group|Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184714|NCT01621802|O5|Outcome|Inv_MMR_S Group|Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
184715|NCT01621802|O4|Outcome|Com_MMR_I Group|Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184716|NCT01621802|O3|Outcome|Inv_MMR_I Group|Subjects received one dose of Priorix at Visit 1 (Day 0).
184717|NCT01621802|O2|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184718|NCT01621802|O1|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184719|NCT01621802|O6|Outcome|Com_MMR_S Group|Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184720|NCT01621802|O5|Outcome|Inv_MMR_S Group|Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
184721|NCT01621802|O4|Outcome|Com_MMR_I Group|Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184722|NCT01621802|O3|Outcome|Inv_MMR_I Group|Subjects received one dose of Priorix at Visit 1 (Day 0).
184723|NCT01621802|O2|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184724|NCT01621802|O1|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184725|NCT01621802|O6|Outcome|Com_MMR_S Group|Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184726|NCT01621802|O5|Outcome|Inv_MMR_S Group|Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
184727|NCT01621802|O4|Outcome|Com_MMR_I Group|Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184728|NCT01621802|O3|Outcome|Inv_MMR_I Group|Subjects received one dose of Priorix at Visit 1 (Day 0).
184729|NCT01621802|O2|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184730|NCT01621802|O1|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184731|NCT01621802|O6|Outcome|Com_MMR_S Group|Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184732|NCT01621802|O5|Outcome|Inv_MMR_S Group|Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
184733|NCT01621802|O4|Outcome|Com_MMR_I Group|Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184734|NCT01621802|O3|Outcome|Inv_MMR_I Group|Subjects received one dose of Priorix at Visit 1 (Day 0).
184735|NCT01621802|O2|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184736|NCT01621802|O1|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184737|NCT01621802|O6|Outcome|Com_MMR_S Group|Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184738|NCT01621802|O5|Outcome|Inv_MMR_S Group|Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
184739|NCT01621802|O4|Outcome|Com_MMR_I Group|Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184740|NCT01621802|O3|Outcome|Inv_MMR_I Group|Subjects received one dose of Priorix at Visit 1 (Day 0).
184741|NCT01621802|O2|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184742|NCT01621802|O1|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184743|NCT01621802|O6|Outcome|Com_MMR_S Group|Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184744|NCT01621802|O5|Outcome|Inv_MMR_S Group|Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
184745|NCT01621802|O4|Outcome|Com_MMR_I Group|Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184746|NCT01621802|O3|Outcome|Inv_MMR_I Group|Subjects received one dose of Priorix at Visit 1 (Day 0).
184747|NCT01621802|O2|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184748|NCT01621802|O1|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184749|NCT01621802|O2|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184750|NCT01621802|O1|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184751|NCT01621802|O6|Outcome|Com_MMR_S Group|Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184752|NCT01621802|O5|Outcome|Inv_MMR_S Group|Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
184753|NCT01621802|O4|Outcome|Com_MMR_I Group|Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184754|NCT01621802|O3|Outcome|Inv_MMR_I Group|Subjects received one dose of Priorix at Visit 1 (Day 0).
184755|NCT01621802|O2|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184756|NCT01621802|O1|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184757|NCT01621802|O2|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184758|NCT01621802|O1|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184759|NCT01621802|O2|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184760|NCT01621802|O1|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
194302|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
184761|NCT01621802|O2|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184762|NCT01621802|O1|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184763|NCT01621802|O2|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184764|NCT01621802|O1|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184765|NCT01621802|O2|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184766|NCT01621802|O1|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184767|NCT01621802|O2|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184768|NCT01621802|O1|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184769|NCT01621802|O2|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184770|NCT01621802|O1|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184771|NCT01621802|O2|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184772|NCT01621802|O1|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184773|NCT01621802|O2|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184774|NCT01621802|O1|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184775|NCT01621802|O2|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184776|NCT01621802|O1|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184777|NCT01621802|O2|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184778|NCT01621802|O1|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184779|NCT01621802|O4|Outcome|Com_MMR_I Group|Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184780|NCT01621802|O3|Outcome|Inv_MMR_I Group|Subjects received one dose of Priorix at Visit 1 (Day 0).
184781|NCT01621802|O2|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184782|NCT01621802|O1|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184783|NCT01621802|O4|Outcome|Com_MMR_I Group|Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184784|NCT01621802|O3|Outcome|Inv_MMR_I Group|Subjects received one dose of Priorix at Visit 1 (Day 0).
184785|NCT01621802|O2|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184786|NCT01621802|O1|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184787|NCT01621802|O4|Outcome|Com_MMR_I Group|Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184788|NCT01621802|O3|Outcome|Inv_MMR_I Group|Subjects received one dose of Priorix at Visit 1 (Day 0).
184789|NCT01621802|O2|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184790|NCT01621802|O1|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184791|NCT01621802|O4|Outcome|Com_MMR_I Group|Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184792|NCT01621802|O3|Outcome|Inv_MMR_I Group|Subjects received one dose of Priorix at Visit 1 (Day 0).
184793|NCT01621802|O2|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184794|NCT01621802|O1|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184795|NCT01621802|O4|Outcome|Com_MMR_I Group|Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184796|NCT01621802|O3|Outcome|Inv_MMR_I Group|Subjects received one dose of Priorix at Visit 1 (Day 0).
184797|NCT01621802|O2|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184798|NCT01621802|O1|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184799|NCT01621802|O4|Outcome|Com_MMR_I Group|Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184800|NCT01621802|O3|Outcome|Inv_MMR_I Group|Subjects received one dose of Priorix at Visit 1 (Day 0).
185566|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
184801|NCT01621802|O2|Outcome|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184802|NCT01621802|O1|Outcome|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184803|NCT01621802|E6|Reported Event|Com_MMR_S Group|Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184804|NCT01621802|E5|Reported Event|Inv_MMR_S Group|Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
184805|NCT01621802|E4|Reported Event|Com_MMR_I Group|Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
184806|NCT01621802|E3|Reported Event|Inv_MMR_I Group|Subjects received one dose of Priorix at Visit 1 (Day 0).
184807|NCT01621802|E2|Reported Event|Com_MMR_CO Group|Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184808|NCT01621802|E1|Reported Event|Inv_MMR_CO Group|Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
184809|NCT01621776|B4|Baseline|Total|Total of all reporting groups
184810|NCT01621776|B3|Baseline|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
184811|NCT01621776|B2|Baseline|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
184812|NCT01621776|B1|Baseline|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
184813|NCT01621776|P3|Participant Flow|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
184814|NCT01621776|P2|Participant Flow|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
184815|NCT01621776|P1|Participant Flow|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
184816|NCT01621776|O3|Outcome|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
184817|NCT01621776|O2|Outcome|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
184818|NCT01621776|O1|Outcome|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
184819|NCT01621776|O3|Outcome|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
184820|NCT01621776|O2|Outcome|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
184821|NCT01621776|O1|Outcome|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
184822|NCT01621776|O3|Outcome|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
184823|NCT01621776|O2|Outcome|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
184824|NCT01621776|O1|Outcome|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
184825|NCT01621776|E3|Reported Event|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
184826|NCT01621776|E2|Reported Event|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
184827|NCT01621776|E1|Reported Event|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
184828|NCT01621672|B3|Baseline|Total|Total of all reporting groups
184829|NCT01621672|B2|Baseline|Observation|No treatment
184830|NCT01621672|B1|Baseline|Revlimid|Revlimid: 10 mg/day in the morning same time each day
184831|NCT01621672|P2|Participant Flow|Observation|No treatment
184832|NCT01621672|P1|Participant Flow|Revlimid|Revlimid: 10 mg/day in the morning same time each day
184833|NCT01621672|O2|Outcome|Observation|No treatment
184834|NCT01621672|O1|Outcome|Revlimid|Revlimid: 10 mg/day in the morning same time each day
184835|NCT01621672|E2|Reported Event|Observation|No treatment
184836|NCT01621672|E1|Reported Event|Revlimid|Revlimid: 10 mg/day in the morning same time each day
184837|NCT01621633|B5|Baseline|Total|Total of all reporting groups
184838|NCT01621633|B4|Baseline|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
184839|NCT01621633|B3|Baseline|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
184840|NCT01621633|B2|Baseline|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
184841|NCT01621633|B1|Baseline|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
184842|NCT01621633|P4|Participant Flow|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
184843|NCT01621633|P3|Participant Flow|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
184844|NCT01621633|P2|Participant Flow|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
184845|NCT01621633|P1|Participant Flow|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
184846|NCT01621633|O4|Outcome|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
184847|NCT01621633|O3|Outcome|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
184848|NCT01621633|O2|Outcome|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
184849|NCT01621633|O1|Outcome|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
184850|NCT01621633|O4|Outcome|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
184851|NCT01621633|O3|Outcome|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
184852|NCT01621633|O2|Outcome|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
184853|NCT01621633|O1|Outcome|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
184854|NCT01621633|O4|Outcome|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
184855|NCT01621633|O3|Outcome|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
184856|NCT01621633|O2|Outcome|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
184857|NCT01621633|O1|Outcome|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
184858|NCT01621633|O4|Outcome|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
184859|NCT01621633|O3|Outcome|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
184860|NCT01621633|O2|Outcome|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
184861|NCT01621633|O1|Outcome|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
184862|NCT01621633|E4|Reported Event|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
184863|NCT01621633|E3|Reported Event|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
184864|NCT01621633|E2|Reported Event|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
184865|NCT01621633|E1|Reported Event|Moderate Hepatic Impaired Patients|Moderate hepatic impaired patients
184866|NCT01621477|B1|Baseline|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant. Donors did not receive treatment and are not followed for data collection to answer the study objectives. They are therefore not included in the results reported here.
184867|NCT01621477|P1|Participant Flow|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant.
184868|NCT01621477|O1|Outcome|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant.
184869|NCT01621477|O1|Outcome|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant.
184870|NCT01621477|O1|Outcome|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant.
184871|NCT01621477|O1|Outcome|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant.
184872|NCT01621477|O1|Outcome|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant.
184873|NCT01621477|O1|Outcome|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant.
184874|NCT01621477|O1|Outcome|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant.
184875|NCT01621477|E1|Reported Event|Treatment|Study participants (excluding donors) who were enrolled to receive treatment with clofarabine, cytarabine, busulfan, plerixafor, cyclophosphamide, antithymocyte globulin (rabbit), stem cells, tacrolimus, and mycophenolate mofetil. Donors did not receive treatment and are not followed for data collection to answer the study objectives. They are therefore not included in the results reported here.
184876|NCT01621191|B1|Baseline|Duloxetine 60 mg|"Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).~During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
184877|NCT01621191|P1|Participant Flow|Duloxetine 60 mg|"Treatment Period: Up to a 60-milligram (mg) dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).~During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
184878|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
184879|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
184880|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
184881|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
184882|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
184883|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
184884|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
184885|NCT01621191|O1|Outcome|Duloxetine 60 mg|"Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).~During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
184886|NCT01621191|E1|Reported Event|60 mg Duloxetine|"Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).~During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
184887|NCT01621178|B4|Baseline|Total|Total of all reporting groups
184888|NCT01621178|B3|Baseline|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184889|NCT01621178|B2|Baseline|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184890|NCT01621178|B1|Baseline|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184891|NCT01621178|P3|Participant Flow|1.5 mg Dulaglutide|1.5 mg of dulaglutide was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184892|NCT01621178|P2|Participant Flow|0.75 mg Dulaglutide|0.75 milligram (mg) of dulaglutide was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184893|NCT01621178|P1|Participant Flow|Insulin Glargine|Insulin glargine was administered subcutaneously (SC) at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
185313|NCT01619059|E2|Reported Event|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
184894|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184895|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184896|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184897|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184898|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184899|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184900|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184901|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184902|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184903|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184904|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184905|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184906|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184907|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184908|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184909|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184910|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184911|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184912|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184913|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184914|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184915|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184916|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184917|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184918|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184919|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184973|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184920|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184921|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184922|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184923|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184924|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184925|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184926|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184927|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184928|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184929|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184930|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184931|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184932|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184933|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184934|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184935|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184936|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184937|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184938|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184939|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184940|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184941|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine administered SC to be given at bedtime per sliding scale. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184942|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184943|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184944|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184945|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184946|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184947|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184948|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184949|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184950|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184951|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184952|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184953|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184954|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184955|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184956|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184957|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184958|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184959|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184960|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184961|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184962|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184963|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184964|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184965|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184966|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184967|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184968|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184969|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184970|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184971|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184972|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
185314|NCT01619059|E1|Reported Event|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
184974|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184975|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184976|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184977|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184978|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184979|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184980|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered subcutaneous (SC) at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184981|NCT01621178|E3|Reported Event|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184982|NCT01621178|E2|Reported Event|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184983|NCT01621178|E1|Reported Event|Insulin Glargine|Insulin glargine administered SC to be given at bedtime per sliding scale. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
184984|NCT01621126|B1|Baseline|Intra-op Neuromonitoring|Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor): Device: Intra-operative neuromonitoring A XLTEK/NATUS EP Protektor machine (at MGH) or a Cadwell Cascade Elite neuromonitoring machine (at BWH), both FDA approved for intra-operative neuromonitoring, will deliver the electrical stimulus applied transcranially to stimulate the motor cortex, while motor evoked responses will be recorded from different myotomes from both upper limbs. Also the same equipment will deliver electrical stimulus to stimulate peripherally the median and ulnar nerves at the wrists, with recording of the thalamocortical potentials in the scalp channels.
184985|NCT01621126|P1|Participant Flow|Intra-op Neuromonitoring|Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor): Device: Intra-operative neuromonitoring A XLTEK/NATUS EP Protektor machine (at MGH) or a Cadwell Cascade Elite neuromonitoring machine (at BWH), both FDA approved for intra-operative neuromonitoring, will deliver the electrical stimulus applied transcranially to stimulate the motor cortex, while motor evoked responses will be recorded from different myotomes from both upper limbs. Also the same equipment will deliver electrical stimulus to stimulate peripherally the median and ulnar nerves at the wrists, with recording of the thalamocortical potentials in the scalp channels.
184986|NCT01621126|O1|Outcome|Intra-op Neuromonitoring|Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor): Device: Intra-operative neuromonitoring A XLTEK/NATUS EP Protektor machine (at MGH) or a Cadwell Cascade Elite neuromonitoring machine (at BWH), both FDA approved for intra-operative neuromonitoring, will deliver the electrical stimulus applied transcranially to stimulate the motor cortex, while motor evoked responses will be recorded from different myotomes from both upper limbs. Also the same equipment will deliver electrical stimulus to stimulate peripherally the median and ulnar nerves at the wrists, with recording of the thalamocortical potentials in the scalp channels.
184987|NCT01621126|E1|Reported Event|Intra-op Neuromonitoring|Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor): Device: Intra-operative neuromonitoring A XLTEK/NATUS EP Protektor machine (at MGH) or a Cadwell Cascade Elite neuromonitoring machine (at BWH), both FDA approved for intra-operative neuromonitoring, will deliver the electrical stimulus applied transcranially to stimulate the motor cortex, while motor evoked responses will be recorded from different myotomes from both upper limbs. Also the same equipment will deliver electrical stimulus to stimulate peripherally the median and ulnar nerves at the wrists, with recording of the thalamocortical potentials in the scalp channels.
184988|NCT01621009|B5|Baseline|Total|Total of all reporting groups
184989|NCT01621009|B4|Baseline|Placebo Medication, No Counseling|Placebo bupropion, No counseling, just medication checks
184990|NCT01621009|B3|Baseline|Placebo Medication + Counseling|Placebo bupropion plus eight 10-minute individual counseling sessions
184991|NCT01621009|B2|Baseline|Active Bupropion , No Counseling|Active bupropion, No counseling, only medication checks
184992|NCT01621009|B1|Baseline|Active Bupropion + Counseling|Active bupropion SR plus eight 10-minute individual counseling sessions.
184993|NCT01621009|P4|Participant Flow|Placebo Medication, No Counseling|Placebo bupropion, No counseling, just medication checks
184994|NCT01621009|P3|Participant Flow|Placebo Medication + Counseling|Placebo bupropion plus eight 10-minute individual counseling sessions
184995|NCT01621009|P2|Participant Flow|Active Bupropion , No Counseling|Active bupropion, No counseling, only medication checks
184996|NCT01621009|P1|Participant Flow|Active Bupropion + Counseling|Active bupropion SR plus eight 10-minute individual counseling sessions.
184997|NCT01621009|O4|Outcome|Placebo, No Counseling|": Medications: Pre-quit - Placebo bupropion one per day 3 days before quit day, then two per day 4 days before quit day; placebo bupropion twice daily for 8 weeks after the quit date.~No cessation counseling, medication management and assessment only."
184998|NCT01621009|O3|Outcome|Placebo + Counseling|": Medications: Pre-quit - Placebo bupropion one per day 3 days before quit day, then two per day 4 days before quit day; placebo bupropion twice daily for 8 weeks after the quit date.~Counseling: Pre-quit - Two 10-minute sessions; Post-quit: Eight weekly 10-minute sessions"
185315|NCT01618968|B5|Baseline|Total|Total of all reporting groups
184999|NCT01621009|O2|Outcome|Bupropion, No Counseling|Active bupropion, No counseling: Medications: Medications: Pre-quit - 150mg bupropion SR per day 3 days before quit day, then 150mg twice a day 4 days before quit day; 150mg bupropion SR twice daily for 8 weeks after the quit date. No cessation counseling, medication management and assessment only.
185000|NCT01621009|O1|Outcome|Bupropion + Counseling|"Active bupropion + 8 weeks counseling: Medications: Pre-quit - 150mg bupropion SR per day 3 days before quit day, then 150mg twice a day 4 days before quit day; 150mg bupropion SR twice daily for 8 weeks after the quit date.~Counseling: Pre-quit - Two 10-minute sessions; Post-quit: Eight weekly 10-minute sessions"
185001|NCT01621009|E2|Reported Event|Active Medication|Pre-quit – 150mg bupropion SR per day 3 days before quit day, then 150mg twice a day 4 days before quit day; 150mg bupropion SR twice daily for 8 weeks after the quit date.
185002|NCT01621009|E1|Reported Event|Placebo Medication|Medications: Pre-quit – one placebo pill for 3 days before quit day, then one placebo pill twice a day 4 days before quit day for 8 weeks after the quit date.
185003|NCT01620762|B4|Baseline|Total|Total of all reporting groups
185004|NCT01620762|B3|Baseline|Placebo|"Placebo~Placebo: 1 dose every 4 weeks"
185005|NCT01620762|B2|Baseline|Cat-PAD Treatment 2 (2 Courses)|"Cat-PAD Treatment regimen 2~Cat-PAD: 1 dose every 4 weeks"
185006|NCT01620762|B1|Baseline|Cat-PAD Treatment 1 (1 Course)|"Cat-PAD Treatment 1~Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks"
185007|NCT01620762|P3|Participant Flow|Placebo|"Placebo~Placebo: 1 dose every 4 weeks"
185008|NCT01620762|P2|Participant Flow|Cat-PAD Treatment 2 (2 Courses)|"Cat-PAD Treatment regimen 2~Cat-PAD: 1 dose every 4 weeks"
185009|NCT01620762|P1|Participant Flow|Cat-PAD Treatment 1 (1 Course)|"Cat-PAD Treatment 1~Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks"
185010|NCT01620762|O3|Outcome|Placebo|"Placebo~Placebo: 1 dose every 4 weeks"
185011|NCT01620762|O2|Outcome|Cat-PAD Treatment 2 (2 Courses)|"Cat-PAD Treatment regimen 2~Cat-PAD: 1 dose every 4 weeks"
185012|NCT01620762|O1|Outcome|Cat-PAD Treatment 1 (1 Course)|"Cat-PAD Treatment 1~Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks"
185013|NCT01620762|O3|Outcome|Placebo|"Placebo~Placebo: 1 dose every 4 weeks"
185014|NCT01620762|O2|Outcome|Cat-PAD Treatment 2 (2 Courses)|"Cat-PAD Treatment regimen 2~Cat-PAD: 1 dose every 4 weeks"
185015|NCT01620762|O1|Outcome|Cat-PAD Treatment 1 (1 Course)|"Cat-PAD Treatment 1~Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks"
185016|NCT01620762|O3|Outcome|Placebo|"Placebo~Placebo: 1 dose every 4 weeks"
185017|NCT01620762|O2|Outcome|Cat-PAD Treatment 2 (2 Courses)|"Cat-PAD Treatment regimen 2~Cat-PAD: 1 dose every 4 weeks"
185018|NCT01620762|O1|Outcome|Cat-PAD Treatment 1 (1 Course)|"Cat-PAD Treatment 1~Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks"
185019|NCT01620762|O3|Outcome|Placebo|"Placebo~Placebo: 1 dose every 4 weeks"
185020|NCT01620762|O2|Outcome|Cat-PAD Treatment 2 (2 Courses)|"Cat-PAD Treatment regimen 2~Cat-PAD: 1 dose every 4 weeks"
185021|NCT01620762|O1|Outcome|Cat-PAD Treatment 1 (1 Course)|"Cat-PAD Treatment 1~Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks"
185022|NCT01620762|O3|Outcome|Placebo|"Placebo~Placebo: 1 dose every 4 weeks"
185023|NCT01620762|O2|Outcome|Cat-PAD Treatment 2 (2 Courses)|"Cat-PAD Treatment regimen 2~Cat-PAD: 1 dose every 4 weeks"
185024|NCT01620762|O1|Outcome|Cat-PAD Treatment 1 (1 Course)|"Cat-PAD Treatment 1~Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks"
185025|NCT01620762|O3|Outcome|Placebo|"Placebo~Placebo: 1 dose every 4 weeks"
185026|NCT01620762|O2|Outcome|Cat-PAD Treatment 2 (2 Courses)|"Cat-PAD Treatment regimen 2~Cat-PAD: 1 dose every 4 weeks"
185027|NCT01620762|O1|Outcome|Cat-PAD Treatment 1 (1 Course)|"Cat-PAD Treatment 1~Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks"
185028|NCT01620762|O3|Outcome|Placebo|"Placebo~Placebo: 1 dose every 4 weeks"
185029|NCT01620762|O2|Outcome|Cat-PAD Treatment 2 (2 Courses)|"Cat-PAD Treatment regimen 2~Cat-PAD: 1 dose every 4 weeks"
185030|NCT01620762|O1|Outcome|Cat-PAD Treatment 1 (1 Course)|"Cat-PAD Treatment 1~Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks"
185031|NCT01620762|E3|Reported Event|Placebo|"Placebo~Placebo: 1 dose every 4 weeks"
185032|NCT01620762|E2|Reported Event|Cat-PAD Treatment 2 (2 Courses)|"Cat-PAD Treatment regimen 2~Cat-PAD: 1 dose every 4 weeks"
185033|NCT01620762|E1|Reported Event|Cat-PAD Treatment 1 (1 Course)|"Cat-PAD Treatment 1~Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks"
185034|NCT01620593|B3|Baseline|Total|Total of all reporting groups
185035|NCT01620593|B2|Baseline|Metformin and Castration|"Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy. In the rare case where a patient may not tolerate 500 mg three times a day, he may remain on the study taking only 500 mg twice a day.~Metformin and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient500mg tablets of metformin or placebo, blinded to the patient and the study team."
185036|NCT01620593|B1|Baseline|Placebo and Castration|"Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy.~Placebo and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient 500mg tablets of metformin or placebo, blinded to the patient and the study team."
185037|NCT01620593|P2|Participant Flow|Metformin and Castration|"Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy. In the rare case where a patient may not tolerate 500 mg three times a day, he may remain on the study taking only 500 mg twice a day.~Metformin and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient500mg tablets of metformin or placebo, blinded to the patient and the study team."
185038|NCT01620593|P1|Participant Flow|Placebo and Castration|"Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy.~Placebo and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient 500mg tablets of metformin or placebo, blinded to the patient and the study team."
185389|NCT01618864|B1|Baseline|Luxe Treatment Group|Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.
185039|NCT01620593|O2|Outcome|Metformin and Castration|"Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy. In the rare case where a patient may not tolerate 500 mg three times a day, he may remain on the study taking only 500 mg twice a day.~Metformin and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient500mg tablets of metformin or placebo, blinded to the patient and the study team."
185040|NCT01620593|O1|Outcome|Placebo and Castration|"Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy.~Placebo and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient 500mg tablets of metformin or placebo, blinded to the patient and the study team."
185041|NCT01620593|O2|Outcome|Metformin and Castration|"Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy. In the rare case where a patient may not tolerate 500 mg three times a day, he may remain on the study taking only 500 mg twice a day.~Metformin and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient500mg tablets of metformin or placebo, blinded to the patient and the study team."
185042|NCT01620593|O1|Outcome|Placebo and Castration|"Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy.~Placebo and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient 500mg tablets of metformin or placebo, blinded to the patient and the study team."
185043|NCT01620593|O2|Outcome|Metformin and Castration|"Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy. In the rare case where a patient may not tolerate 500 mg three times a day, he may remain on the study taking only 500 mg twice a day.~Metformin and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient500mg tablets of metformin or placebo, blinded to the patient and the study team."
185044|NCT01620593|O1|Outcome|Placebo and Castration|"Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy.~Placebo and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient 500mg tablets of metformin or placebo, blinded to the patient and the study team."
185045|NCT01620593|O2|Outcome|Metformin and Castration|"Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy. In the rare case where a patient may not tolerate 500 mg three times a day, he may remain on the study taking only 500 mg twice a day.~Metformin and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient500mg tablets of metformin or placebo, blinded to the patient and the study team."
185046|NCT01620593|O1|Outcome|Placebo and Castration|"Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy.~Placebo and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient 500mg tablets of metformin or placebo, blinded to the patient and the study team."
185047|NCT01620593|O2|Outcome|Metformin and Castration|"Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy. In the rare case where a patient may not tolerate 500 mg three times a day, he may remain on the study taking only 500 mg twice a day.~Metformin and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient500mg tablets of metformin or placebo, blinded to the patient and the study team."
185048|NCT01620593|O1|Outcome|Placebo and Castration|"Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy.~Placebo and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient 500mg tablets of metformin or placebo, blinded to the patient and the study team."
185049|NCT01620593|E2|Reported Event|Metformin and Castration|"Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy. In the rare case where a patient may not tolerate 500 mg three times a day, he may remain on the study taking only 500 mg twice a day.~Metformin and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient500mg tablets of metformin or placebo, blinded to the patient and the study team."
185050|NCT01620593|E1|Reported Event|Placebo and Castration|"Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy.~Placebo and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient 500mg tablets of metformin or placebo, blinded to the patient and the study team."
185051|NCT01620489|B3|Baseline|Total|Total of all reporting groups
185052|NCT01620489|B2|Baseline|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
185053|NCT01620489|B1|Baseline|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
185054|NCT01620489|P2|Participant Flow|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
185316|NCT01618968|B4|Baseline|25mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
185055|NCT01620489|P1|Participant Flow|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
185056|NCT01620489|O2|Outcome|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
185057|NCT01620489|O1|Outcome|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
185058|NCT01620489|O2|Outcome|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
185059|NCT01620489|O1|Outcome|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
185060|NCT01620489|O2|Outcome|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
185061|NCT01620489|O1|Outcome|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
185062|NCT01620489|O2|Outcome|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
185063|NCT01620489|O1|Outcome|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
185064|NCT01620489|O2|Outcome|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
185065|NCT01620489|O1|Outcome|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
185066|NCT01620489|O2|Outcome|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
185067|NCT01620489|O1|Outcome|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
185068|NCT01620489|E2|Reported Event|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
185069|NCT01620489|E1|Reported Event|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
185070|NCT01620255|B6|Baseline|Total|Total of all reporting groups
185071|NCT01620255|B5|Baseline|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185072|NCT01620255|B4|Baseline|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185073|NCT01620255|B3|Baseline|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185074|NCT01620255|B2|Baseline|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185075|NCT01620255|B1|Baseline|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185076|NCT01620255|P5|Participant Flow|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185077|NCT01620255|P4|Participant Flow|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185078|NCT01620255|P3|Participant Flow|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185079|NCT01620255|P2|Participant Flow|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185080|NCT01620255|P1|Participant Flow|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 centimeters (cm) apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185081|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185082|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185083|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185084|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185085|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
186429|NCT01613417|O5|Outcome|Reader 3 - ProHance|MRI after ProHance 0.1 mmol/kg
185086|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185087|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185088|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185089|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185090|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185091|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185092|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185093|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185094|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185095|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185096|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185097|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185098|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185099|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185100|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185365|NCT01618955|E1|Reported Event|Vibex MTX 10 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
185101|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185102|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185103|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185104|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185105|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185106|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185107|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185108|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185109|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185110|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185111|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185112|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185113|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185114|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185115|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185366|NCT01618942|B3|Baseline|Total|Total of all reporting groups
185367|NCT01618942|B2|Baseline|Female Subjects|grouped by gender
185116|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185117|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185118|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185119|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185120|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185121|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185122|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185123|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185124|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185125|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185126|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185127|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185128|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185129|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185130|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185368|NCT01618942|B1|Baseline|Male Subjects|grouped by gender
194303|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
185131|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185132|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185133|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185134|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185135|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185136|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185137|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185138|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185139|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185140|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185141|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185142|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185143|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185144|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185145|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185369|NCT01618942|P2|Participant Flow|Female Subjects|grouped by gender grouped by gender and applied with hand-held pressure algometer with differen
185146|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185147|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185148|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185149|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185150|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185151|NCT01620255|E5|Reported Event|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185152|NCT01620255|E4|Reported Event|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185153|NCT01620255|E3|Reported Event|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185154|NCT01620255|E2|Reported Event|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185155|NCT01620255|E1|Reported Event|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
185156|NCT01620177|B1|Baseline|Overall Study|Individuals who completed the study completed all six arms of the study and the data is aggregated. Non-completers may have completed some arms and not others and their data is aggregated.
185157|NCT01620177|P1|Participant Flow|Overall Study|Individuals who completed the study completed all six arms of the study and the data is aggregated. Non-completers may have completed some arms and not others and their data is aggregated. There will be six study visits where the subject will arrive at the Clinical Research Unit(University of Iowa Hospitals & Clinics) the night before dosing. At each visit subjects will be receive one of the following six dosing regimens: placebo alcohol with placebo cannabis; placebo alcohol with low-dose cannabis, placebo alcohol with higher-dose of cannabis, low dose alcohol with placebo cannabis; low dose alcohol with low dose cannabis, low dose alcohol with higher-dose of cannabis.
185158|NCT01620177|O6|Outcome|0% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
185159|NCT01620177|O5|Outcome|6.0-7.5% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
185160|NCT01620177|O4|Outcome|2.5-3.5% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
185161|NCT01620177|O3|Outcome|6.0-7.5% THC and 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
185162|NCT01620177|O2|Outcome|2.5-3.5% THC With 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
185163|NCT01620177|O1|Outcome|0% THC With 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
185164|NCT01620177|O6|Outcome|0% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
185165|NCT01620177|O5|Outcome|6.0-7.5% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
185166|NCT01620177|O4|Outcome|2.5-3.5% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
185167|NCT01620177|O3|Outcome|6.0-7.5% THC and 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
185168|NCT01620177|O2|Outcome|2.5-3.5% THC With 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
185169|NCT01620177|O1|Outcome|0% THC With 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
185170|NCT01620177|O3|Outcome|THC x BrAC|Data from all dosing conditions combined to estimate the interactive effect of THC and BrAC concentrations using a regression equation.
185171|NCT01620177|O2|Outcome|Alcohol - BrAC (Breath Alcohol Concentration)|Data from all dosing conditions combined to estimate the effect of BrACconcentrations using a regression equation.
185172|NCT01620177|O1|Outcome|Cannabis - THC|Data from all dosing conditions combined to estimate the effect of THC concentrations using a regression equation.
185173|NCT01620177|E6|Reported Event|0% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
185174|NCT01620177|E5|Reported Event|6.0-7.5% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
185175|NCT01620177|E4|Reported Event|2.5-3.5% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
185176|NCT01620177|E3|Reported Event|6.0-7.5% THC and 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
185177|NCT01620177|E2|Reported Event|2.5-3.5% THC With 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
185178|NCT01620177|E1|Reported Event|0% THC With 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
185179|NCT01620138|B3|Baseline|Total|Total of all reporting groups
185180|NCT01620138|B2|Baseline|Cabergoline|"In patients with non-functioning pituitary adenoma, treatment will be started at least 3 months after neurosurgery. The drug response will be evaluated clinically by visual field and by Magnetic resonance imaging (MRI) before medical treatment and after six months of cabergoline treatment at maximum dose.~cabergoline: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.~The patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
185181|NCT01620138|B1|Baseline|Pasireotide|"For non-cured patients with resistant prolactinomas , MRI will be performed before and six months after the onset of pasireotide. The efficacy will be evaluated by prolactin dosage every month.~For patients harboring a NFPA, treatment will be started at least 3 months after neurosurgery. In this case, the drug efficacy will be evaluated clinically by MRI six months after pasireotide.~Pasireotide: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at the dosage of 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for six months.~The patients with resistant prolactinomas will be treated with pasireotide at the dosage of 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
185182|NCT01620138|P2|Participant Flow|Cabergoline|"In patients with non-functioning pituitary adenoma, treatment will be started at least 3 months after neurosurgery. The drug response will be evaluated clinically by visual field and by Magnetic resonance imaging (MRI) before medical treatment and after six months of cabergoline treatment at maximum dose.~cabergoline: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.~The patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
185183|NCT01620138|P1|Participant Flow|Pasireotide|"Non-cured patients with resistant prolactinomas, MRI will be performed immediately before and six months after the onset of pasireotide. The efficacy will be evaluated by prolactin dosage every month.~Patients with a nonfunctioning pituitary adenoma (NFPA), treatment will be started at least 3 months after neurosurgery. The efficacy will be evaluated by MRI 6 months after pasireotide.~Pasireotide: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at the dosage of 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.~The patients with resistant prolactinomas will be treated with pasireotide at the dosage of 600 µg s.c. twice a day. After 4 weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for 6 months."
185184|NCT01620138|O2|Outcome|Cabergoline|"In patients with non-functioning pituitary adenoma, treatment will be started at least 3 months after neurosurgery. The drug response will be evaluated clinically by visual field and by Magnetic resonance imaging (MRI) before medical treatment and after six months of cabergoline treatment at maximum dose.~cabergoline: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.~The patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
185185|NCT01620138|O1|Outcome|Pasireotide|"For non-cured patients with resistant prolactinomas, MRI will be performed immediately before and six months after the onset of pasireotide. The efficacy will be evaluated by prolactin dosage every month.~For patients harboring a NFPA, treatment will be started at least 3 months after neurosurgery. In this case, the drug efficacy will be evaluated by MRI six months after pasireotide.~Pasireotide: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at the dosage of 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for six months.~The patients with resistant prolactinomas will be treated with pasireotide at the dosage of 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
185205|NCT01620086|O4|Outcome|Patients: Active 1Hz Treatment Site - Baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
185231|NCT01619982|B2|Baseline|Cefazolin 30 mg/kg Body Weight|Cefazolin 30 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
185186|NCT01620138|E2|Reported Event|Cabergoline|"In patients with non-functioning pituitary adenoma, treatment will be started at least 3 months after neurosurgery. The drug response will be evaluated clinically by visual field and by Magnetic resonance imaging (MRI) before medical treatment and after six months of cabergoline treatment at maximum dose.~cabergoline: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.~The patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
185187|NCT01620138|E1|Reported Event|Pasireotide|"For non-cured patients with resistant prolactinomas , MRI will be performed immediately before and six months after the onset of pasireotide . The efficacy will be evaluated by prolactin dosage every month.~For patients harboring a NFPA, treatment will be started at least 3 months after neurosurgery. In this case, the drug efficacy will be evaluated by MRI six months after pasireotide.~Pasireotide: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at the dosage of 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for six months.~The patients with resistant prolactinomas will be treated with pasireotide at the dosage of 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
185188|NCT01620086|B3|Baseline|Total|Total of all reporting groups
185189|NCT01620086|B2|Baseline|Controls|These subjects are normal controls without schizophrenia who get stimulation over the vertex.
185190|NCT01620086|B1|Baseline|Patients|Patients with Schizophrenia who meet entry criteria for the study and get stimulation over temporal cortex.
185191|NCT01620086|P3|Participant Flow|Patients: Baseline, Control Site, 10Hz First|These are schizophrenic patients who meet entry criteria for the study. Patients in this arm receive baseline testing, then control site stimulation at 1Hz or 10 Hz over the control site at the vertex, and then were randomized to receive 10 Hz over the treatment site in temporal cortex before receiving 1 Hz over the treatment site in temporal cortex. All treatment is for four days.
185192|NCT01620086|P2|Participant Flow|Patients: Baseline, Control Site, & 1Hz First|These are schizophrenic patients who meet entry criteria for the study. Patients in this arm receive baseline testing, then control site stimulation at 1Hz or 10 Hz located over the control site at the vertex, and then were randomized to receive 1 Hz over the treatment site in temporal cortex before receiving 10 Hz over the treatment site in temporal cortex. All stimulation is delivered for four days.
185193|NCT01620086|P1|Participant Flow|Controls: Baseline, 1Hz Sham, 1 Hz Active Over Vertex|These subjects are normal controls without schizophrenia who receive baseline testing, then sham rTMS, and then active 1Hz rTMS. All stimulation is for two days and delivered over the control site located at the vertex.
185194|NCT01620086|O5|Outcome|Patients: Active 10 Hz Treatment Site-baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
185195|NCT01620086|O4|Outcome|Patients: Active 1Hz Treatment Site - Baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
185196|NCT01620086|O3|Outcome|Patients: Control Site-baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
185197|NCT01620086|O2|Outcome|Controls: Sham Contorl Site rTMS - Baseline|"These subjects are normal controls without schizophrenia.~Baseline, no stimulation~Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex~Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex"
185198|NCT01620086|O1|Outcome|Controls: 1Hz Control Site Active-Baseline|"These subjects are normal controls without schizophrenia.~Baseline, no stimulation~Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex~Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex"
185199|NCT01620086|O5|Outcome|Patients: Active 10 Hz Treatment Site-baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
185200|NCT01620086|O4|Outcome|Patients: Active 1Hz Treatment Site - Baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
185201|NCT01620086|O3|Outcome|Patients: Control Site-baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
185202|NCT01620086|O2|Outcome|Controls: Sham Contorl Site rTMS - Baseline|"These subjects are normal controls without schizophrenia.~Baseline, no stimulation~Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex~Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex"
185203|NCT01620086|O1|Outcome|Controls: 1Hz Control Site Active-Baseline|"These subjects are normal controls without schizophrenia.~Baseline, no stimulation~Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex~Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex"
185204|NCT01620086|O5|Outcome|Patients: Active 10 Hz Treatment Site-baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
185206|NCT01620086|O3|Outcome|Patients: Control Site-baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
185207|NCT01620086|O2|Outcome|Controls: Sham Contorl Site rTMS - Baseline|"These subjects are normal controls without schizophrenia.~Baseline, no stimulation~Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex~Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex"
185208|NCT01620086|O1|Outcome|Controls: 1Hz Control Site Active-Baseline|"These subjects are normal controls without schizophrenia.~Baseline, no stimulation~Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex~Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex"
185209|NCT01620086|E2|Reported Event|Controls|These subjects are normal controls without schizophrenia.
185210|NCT01620086|E1|Reported Event|Patients|These are schizophrenic patients who meet entry criteria for the study.
185211|NCT01620060|B1|Baseline|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day~Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
185212|NCT01620060|P1|Participant Flow|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day~Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
185213|NCT01620060|O1|Outcome|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day~Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
185214|NCT01620060|O1|Outcome|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day~Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
185215|NCT01620060|O1|Outcome|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day~Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
185216|NCT01620060|E1|Reported Event|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day~Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
185217|NCT01620047|B4|Baseline|Total|Total of all reporting groups
185218|NCT01620047|B3|Baseline|Intravenous Fentanyl With Placebo|Control group which received 0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
185219|NCT01620047|B2|Baseline|Femoral Nerve Ropivacaine|Ropivacaine 0.1% continuously delivered through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
185220|NCT01620047|B1|Baseline|Femoral Nerve Fentanyl|Fentanyl 3 µg/ml delivered continuously through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
185221|NCT01620047|P3|Participant Flow|Intravenous Fentanyl|Control group which received 0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
185222|NCT01620047|P2|Participant Flow|Femoral Nerve Ropivacaine|Ropivacaine 0.1% continuously delivered through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
185223|NCT01620047|P1|Participant Flow|Femoral Nerve Fentanyl|Fentanyl 3 µg/ml delivered continuously through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
185224|NCT01620047|O3|Outcome|Intravenous Fentanyl With Placebo|Control group which received 0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
185225|NCT01620047|O2|Outcome|Femoral Nerve Ropivacaine|Ropivacaine 0.1% continuously delivered through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
185226|NCT01620047|O1|Outcome|Femoral Nerve Fentanyl|Fentanyl 3 µg/ml delivered continuously through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
185227|NCT01620047|E3|Reported Event|Intravenous Fentanyl With Placebo|Control group which received 0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
185228|NCT01620047|E2|Reported Event|Femoral Nerve Ropivacaine|Ropivacaine 0.1% continuously delivered through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
185229|NCT01620047|E1|Reported Event|Femoral Nerve Fentanyl|Fentanyl 3 µg/ml delivered continuously through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
185230|NCT01619982|B3|Baseline|Total|Total of all reporting groups
185312|NCT01619059|O1|Outcome|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
185232|NCT01619982|B1|Baseline|Cefazolin 25 mg/kg Body Weight and Vancomycin|"Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.~Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or at 12 hours if patient younger than 1 month of age."
185233|NCT01619982|P2|Participant Flow|Cefazolin 30 mg/kg Body Weight|Cefazolin 30 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
185234|NCT01619982|P1|Participant Flow|Cefazolin 25 mg/kg Body Weight and Vancomycin|"Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.~Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or at 12 hours if patient younger than 1 month of age."
185235|NCT01619982|O2|Outcome|Cefazolin 30mg/kg Body Weight|Cefazolin pre-operative prophylaxis: Cefazolin 30 mg/kg/dose administered intravenously over 5 minutes within 60 minutes of surgical incision and then re-dosed (30mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
185236|NCT01619982|O1|Outcome|Cefazolin 25 mg/kg Body Weight and Vancomycin|"Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.~Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or 12 hours if patient younger than 1 month of age."
185237|NCT01619982|O2|Outcome|Cefazolin 30mg/kg Body Weight|Cefazolin 30 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
185238|NCT01619982|O1|Outcome|Cefazolin 25 mg/kg Body Weight and Vancomycin|"Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.~Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or 12 hours if patient younger than 1 month of age."
185239|NCT01619982|O2|Outcome|Cefazolin 30mg/kg Body Weight|Cefazolin 30 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
185240|NCT01619982|O1|Outcome|Cefazolin 25 mg/kg Body Weight and Vancomycin|"Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.~Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or 12 hours if patient younger than 1 month of age."
185241|NCT01619982|O2|Outcome|Cefazolin 30mg/kg Body Weight|Cefazolin 30 mg/kg/dose administered intravenously over 5 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
185242|NCT01619982|O1|Outcome|Cefazolin 25 mg/kg Body Weight and Vancomycin|"Cefazolin 25 mg/kg/dose administered intravenously over 5 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.~Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or 12 hours if patient younger than 1 month of age."
185243|NCT01619982|O2|Outcome|Cefazolin 30mg/kg Body Weight|Cefazolin 30 mg/kg/dose administered intravenously over 5 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
185244|NCT01619982|O1|Outcome|Cefazolin 25 mg/kg Body Weight and Vancomycin|"Cefazolin 25 mg/kg/dose administered intravenously over 5 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.~Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or 12 hours if patient younger than 1 month of age."
185245|NCT01619982|O2|Outcome|Cefazolin 30mg/kg Body Weight|Cefazolin 30 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
185246|NCT01619982|O1|Outcome|Cefazolin 25mg/kg Body Weight and Vancomycin|"Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.~Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or 12 hours if patient younger than 1 month of age."
185370|NCT01618942|P1|Participant Flow|Male Subjects|grouped by gender and applied with hand-held pressure algometer with differen
185247|NCT01619982|E2|Reported Event|Cefazolin30 mg/kg Body Weight|Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
185248|NCT01619982|E1|Reported Event|Cefazolin 25 mg/kg Body Weight and Vancomycin|"Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.~Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or 12 hours if patient younger than 1 month of age."
185249|NCT01619878|B1|Baseline|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
185250|NCT01619878|P1|Participant Flow|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
185251|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
185252|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
185253|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
185254|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
185255|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
185256|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
185257|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
185258|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
185259|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
185260|NCT01619878|E1|Reported Event|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
185261|NCT01619800|B3|Baseline|Total|Total of all reporting groups
185262|NCT01619800|B2|Baseline|Accelerometer Alone (AA)|Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active
185263|NCT01619800|B1|Baseline|Blended Sensor Optimization (BSO)|Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated
185264|NCT01619800|P2|Participant Flow|Accelerometer Alone (AA)|Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active
185265|NCT01619800|P1|Participant Flow|Blended Sensor Optimization (BSO)|Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated
185266|NCT01619800|O2|Outcome|Accelerometer Alone (AA)|Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active
185267|NCT01619800|O1|Outcome|Blended Sensor Optimization (BSO)|Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated
185268|NCT01619800|E2|Reported Event|Accelerometer Alone (AA)|Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active
185269|NCT01619800|E1|Reported Event|Blended Sensor Optimization (BSO)|Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated
185270|NCT01619787|B3|Baseline|Total|Total of all reporting groups
185271|NCT01619787|B2|Baseline|Overweight/Obese Participants|"Participants whose baseline BMI is greater than or equal to 25.~All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study; therefore, 5 participants were lost to follow up and no age or body mass index are reported for these participants."
185272|NCT01619787|B1|Baseline|Lean Participants|"Participants whose baseline BMI is less than 25.~All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study; therefore, 5 participants were lost to follow up and no age or body mass index are reported for these participants."
185273|NCT01619787|P1|Participant Flow|Online Grocery|All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study.
185274|NCT01619787|O3|Outcome|Overweight/Obese Participants|Participants with BMI greater than or equal to 25.
185275|NCT01619787|O2|Outcome|Lean Participants|Participants with BMI less than 25.
185276|NCT01619787|O1|Outcome|Online Grocery|All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study.
185277|NCT01619787|O3|Outcome|Overweight/Obese Participants|Participants with BMI greater than or equal to 25.
185278|NCT01619787|O2|Outcome|Lean Participants|Participants with BMI less than 25.
185371|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
185372|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
185279|NCT01619787|O1|Outcome|Online Grocery|All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study.
185280|NCT01619787|E1|Reported Event|Online Grocery|All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy, along with the Three Factor Eating Questionnaire were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study.
185281|NCT01619774|B1|Baseline|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
185282|NCT01619774|P1|Participant Flow|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
185283|NCT01619774|O1|Outcome|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
185284|NCT01619774|O1|Outcome|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
185285|NCT01619774|O1|Outcome|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
185286|NCT01619774|E1|Reported Event|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
185287|NCT01619579|B3|Baseline|Total|Total of all reporting groups
185288|NCT01619579|B2|Baseline|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
185289|NCT01619579|B1|Baseline|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home.
185290|NCT01619579|P2|Participant Flow|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily.
185291|NCT01619579|P1|Participant Flow|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily.
185292|NCT01619579|O2|Outcome|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
185293|NCT01619579|O1|Outcome|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home.
185294|NCT01619579|O2|Outcome|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
185295|NCT01619579|O1|Outcome|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home.
185296|NCT01619579|O2|Outcome|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
185297|NCT01619579|O1|Outcome|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home.
185298|NCT01619579|E2|Reported Event|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
185299|NCT01619579|E1|Reported Event|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home.
185300|NCT01619059|B3|Baseline|Total|Total of all reporting groups
185301|NCT01619059|B2|Baseline|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
185302|NCT01619059|B1|Baseline|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
185303|NCT01619059|P2|Participant Flow|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
185304|NCT01619059|P1|Participant Flow|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
185305|NCT01619059|O2|Outcome|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
185306|NCT01619059|O1|Outcome|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
185307|NCT01619059|O2|Outcome|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
185308|NCT01619059|O1|Outcome|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
185309|NCT01619059|O2|Outcome|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
185310|NCT01619059|O1|Outcome|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
185311|NCT01619059|O2|Outcome|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
185373|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
185374|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
185317|NCT01618968|B3|Baseline|20mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
185318|NCT01618968|B2|Baseline|15mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
185319|NCT01618968|B1|Baseline|10mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
185320|NCT01618968|P4|Participant Flow|25mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
185321|NCT01618968|P3|Participant Flow|20mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
185322|NCT01618968|P2|Participant Flow|15mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
185323|NCT01618968|P1|Participant Flow|10mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
185324|NCT01618968|O3|Outcome|Treatment C|SC injection of Vibex MTX into the Thigh
185325|NCT01618968|O2|Outcome|Treatment B|SC injection of Vibex MTX into the Abdomen
185326|NCT01618968|O1|Outcome|Treatment A|Oral Methotrexate (MTX) Tablets
185327|NCT01618968|O3|Outcome|Treatment C|SC injection of Vibex MTX into the Thigh
185328|NCT01618968|O2|Outcome|Treatment B|SC injection of Vibex MTX into the Abdomen
185329|NCT01618968|O1|Outcome|Treatment A|Oral Methotrexate (MTX) Tablets
185330|NCT01618968|O3|Outcome|Treatment C|SC injection of Vibex MTX into the Thigh
185331|NCT01618968|O2|Outcome|Treatment B|SC injection of Vibex MTX into the Abdomen
185332|NCT01618968|O1|Outcome|Treatment A|Oral Methotrexate (MTX) Tablets
185333|NCT01618968|E4|Reported Event|25mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
185334|NCT01618968|E3|Reported Event|20mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
185335|NCT01618968|E2|Reported Event|15mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
185336|NCT01618968|E1|Reported Event|10mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
185337|NCT01618955|B5|Baseline|Total|Total of all reporting groups
185338|NCT01618955|B4|Baseline|MTX 25 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
185339|NCT01618955|B3|Baseline|MTX 20 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
185340|NCT01618955|B2|Baseline|MTX 15 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
185341|NCT01618955|B1|Baseline|MTX 10 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
185342|NCT01618955|P4|Participant Flow|MTX 25 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
185343|NCT01618955|P3|Participant Flow|MTX 20 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
185344|NCT01618955|P2|Participant Flow|MTX 15 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
185345|NCT01618955|P1|Participant Flow|MTX 10 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
185346|NCT01618955|O4|Outcome|Vibex MTX 25 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
185347|NCT01618955|O3|Outcome|Vibex MTX 20 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
185348|NCT01618955|O2|Outcome|Vibex MTX 15 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
185349|NCT01618955|O1|Outcome|Vibex MTX 10 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
185350|NCT01618955|O4|Outcome|Vibex MTX 25 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
185351|NCT01618955|O3|Outcome|Vibex MTX 20 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
185352|NCT01618955|O2|Outcome|Vibex MTX 15 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
185353|NCT01618955|O1|Outcome|Vibex MTX 10 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
185354|NCT01618955|O4|Outcome|Vibex MTX 25 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
185355|NCT01618955|O3|Outcome|Vibex MTX 20 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
185356|NCT01618955|O2|Outcome|Vibex MTX 15 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
185357|NCT01618955|O1|Outcome|Vibex MTX 10 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
185358|NCT01618955|O4|Outcome|Vibex MTX 25 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
185359|NCT01618955|O3|Outcome|Vibex MTX 20 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
185360|NCT01618955|O2|Outcome|Vibex MTX 15 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
185361|NCT01618955|O1|Outcome|Vibex MTX 10 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
185362|NCT01618955|E4|Reported Event|Vibex MTX 25 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
185363|NCT01618955|E3|Reported Event|Vibex MTX 20 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
185364|NCT01618955|E2|Reported Event|Vibex MTX 15 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
185390|NCT01618864|P1|Participant Flow|Luxe Treatment Group|Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.
185391|NCT01618864|O2|Outcome|Luxe Treatment Group at 8 Weeks|Evaluation of rosacea after 8 weeks of treatment.
185392|NCT01618864|O1|Outcome|Luxe Treatment Group at 4 Weeks|Subjects with rosacea were evaluated by the investigator and a score provided according to a validated rosacea scale for improvement in features of rosacea such as flushing.
185393|NCT01618864|O2|Outcome|Luxe Treatment Group at 8 Weeks|Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks and assessment at week 8.
185394|NCT01618864|O1|Outcome|Luxe Treatment Group at 4 Weeks|Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by assessment.
185395|NCT01618864|O2|Outcome|Luxe Treatment Group at 8 Weeks|GAI assessment by investigator at 8 weeks.
185396|NCT01618864|O1|Outcome|Luxe Treatment Group at 4 Weeks|Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.
185397|NCT01618864|E1|Reported Event|Treatment Group|All treated subjects were evaluated for adverse events during the study.
185398|NCT01618838|B1|Baseline|CyberKnife Radiosurgery, Colonoscopy|"CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).~CyberKnife radiosurgery: Treatment Planning:~Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively."
185399|NCT01618838|P1|Participant Flow|CyberKnife Radiosurgery, Colonoscopy|"CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).~CyberKnife radiosurgery: Treatment Planning:~Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively."
185400|NCT01618838|O1|Outcome|CyberKnife Radiosurgery, Colonoscopy|"CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).~CyberKnife radiosurgery: Treatment Planning:~Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively."
185401|NCT01618838|E1|Reported Event|CyberKnife Radiosurgery, Colonoscopy|"CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).~CyberKnife radiosurgery: Treatment Planning:~Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively."
185402|NCT01618708|B3|Baseline|Total|Total of all reporting groups
185403|NCT01618708|B2|Baseline|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
185404|NCT01618708|B1|Baseline|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
185405|NCT01618708|P2|Participant Flow|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
185406|NCT01618708|P1|Participant Flow|Placebo|Single 6 mL intraarticular (IA) injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
185407|NCT01618708|O2|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
185408|NCT01618708|O1|Outcome|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
185409|NCT01618708|O2|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
185410|NCT01618708|O1|Outcome|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
185411|NCT01618708|O2|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
185412|NCT01618708|O1|Outcome|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One at Day 1. Participants were observed for 26 weeks in follow up period.
185413|NCT01618708|O2|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
185414|NCT01618708|O1|Outcome|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
185415|NCT01618708|E2|Reported Event|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
185416|NCT01618708|E1|Reported Event|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
185417|NCT01618669|B3|Baseline|Total|Total of all reporting groups
185418|NCT01618669|B2|Baseline|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185419|NCT01618669|B1|Baseline|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185420|NCT01618669|P2|Participant Flow|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185421|NCT01618669|P1|Participant Flow|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT myocardial perfusion imaging (MPI). One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185422|NCT01618669|O4|Outcome|Regadenoson Alone: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185423|NCT01618669|O3|Outcome|Regadenoson Alone: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185424|NCT01618669|O2|Outcome|Regadenoson After Peak Exercise: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185425|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185426|NCT01618669|O4|Outcome|Regadenoson Alone: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185427|NCT01618669|O3|Outcome|Regadenoson Alone: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185428|NCT01618669|O2|Outcome|Regadenoson After Peak Exercise: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185429|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185430|NCT01618669|O4|Outcome|Regadenoson Alone: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185431|NCT01618669|O3|Outcome|Regadenoson Alone: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185432|NCT01618669|O2|Outcome|Regadenoson After Peak Exercise: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185433|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185434|NCT01618669|O4|Outcome|Regadenoson Alone: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185435|NCT01618669|O3|Outcome|Regadenoson Alone: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185436|NCT01618669|O2|Outcome|Regadenoson After Peak Exercise: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185437|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185438|NCT01618669|O2|Outcome|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185652|NCT01617655|O1|Outcome|Placebo Q2W|Participants exposed to placebo Q2W on top of stable LMT (mean exposure of 78 weeks).
185439|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185440|NCT01618669|O2|Outcome|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185441|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185442|NCT01618669|O6|Outcome|REG Alone: MPI 2 SDS ≥ 14|Participants in the Regadenoson (REG) Alone group who had an SDS ≥ 14 on their second stress scan.
185443|NCT01618669|O5|Outcome|REG Alone: MPI 2 SDS 7-13|Participants in the Regadenoson (REG) Alone group who had an SDS from 7 to 13 on their second stress scan.
185444|NCT01618669|O4|Outcome|REG Alone: MPI 2 SDS 0-6|Participants in the Regadenoson (REG) Alone group who had an SDS from 0 to 6 on their second stress scan.
185445|NCT01618669|O3|Outcome|REG APEX: MPI 2 SDS ≥ 14|Participants in the Regadenoson After Peak Exercise (REG APEX) group who had an SDS ≥ 14 on their second stress scan.
185446|NCT01618669|O2|Outcome|REG APEX: MPI 2 7-13|Participants in the Regadenoson After Peak Exercise (REG APEX) group who had an SDS from 7 to 13 on their second stress scan.
185447|NCT01618669|O1|Outcome|REG APEX: MPI 2 SDS 0-6|Participants in the Regadenoson After Peak Exercise (APEX) group who had an SDS from 0 to 6 on their second stress scan.
185448|NCT01618669|O2|Outcome|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185449|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185450|NCT01618669|O2|Outcome|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185451|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185452|NCT01618669|O2|Outcome|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185453|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185454|NCT01618669|O4|Outcome|Regadenoson Alone: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185455|NCT01618669|O3|Outcome|Regadenoson Alone: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185456|NCT01618669|O2|Outcome|Regadenoson After Peak Exercise: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185457|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185458|NCT01618669|O2|Outcome|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185459|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185460|NCT01618669|E4|Reported Event|Regadenoson Alone: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185461|NCT01618669|E3|Reported Event|Regadenoson Alone: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185462|NCT01618669|E2|Reported Event|Regadenoson After Peak Exercise: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185463|NCT01618669|E1|Reported Event|Regadenoson After Peak Exercise: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
185464|NCT01618422|B3|Baseline|Total|Total of all reporting groups
185485|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
185486|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
185653|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185465|NCT01618422|B2|Baseline|DOTS Plus|Directly Observed Therapy (DOTS) plus: The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and second-line drugs. The regimen used to treat MDR-TB comprises 5 to 6 drugs to which the organism is or likely to be susceptible for the initial 6 months, and then 3 to 4 drugs subsequently. In addition, TB cases with rifampicin resistance but not amounting to MDR-TB are also at risk of unfavourable treatment outcomes. The availability of pretreatment susceptibility test results will provide a guide in selection of drugs in treating such cases.
185466|NCT01618422|B1|Baseline|DOTS Strategy|The standard regimen for treatment of new cases of pulmonary TB consists of 6 months treatment, with 4 drugs in the initial phase including isoniazid, rifampicin, pyrazinamide, and either ethambutol or streptomycin, followed by two drugs in the continuation phase including isoniazid and rifampicin.
185467|NCT01618422|P2|Participant Flow|DOTS Plus|"The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and second-line drugs. The regimen used to treat MDR-TB comprises 5 to 6 drugs to which the organism is or likely to be susceptible for the initial 6 months, and then 3 to 4 drugs subsequently. In addition, TB cases with rifampicin resistance but not amounting to MDR-TB are also at risk of unfavourable treatment outcomes. The availability of pretreatment susceptibility test results will provide a guide in selection of drugs in treating such cases.~Directly Observed Therapy (DOTS) plus: The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and"
185468|NCT01618422|P1|Participant Flow|DOTS Strategy|The standard regimen for treatment of new cases of pulmonary TB consists of 6 months treatment, with 4 drugs in the initial phase including isoniazid, rifampicin, pyrazinamide, and either ethambutol or streptomycin, followed by two drugs in the continuation phase including isoniazid and rifampicin. In the treatment of previously treated cases, a standard regimen consisting of 8 months treatment will be used.
185469|NCT01618422|O2|Outcome|DOTS Plus|Directly Observed Therapy (DOTS) plus: The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and second-line drugs. The regimen used to treat MDR-TB comprises 5 to 6 drugs to which the organism is or likely to be susceptible for the initial 6 months, and then 3 to 4 drugs subsequently. In addition, TB cases with rifampicin resistance but not amounting to MDR-TB are also at risk of unfavourable treatment outcomes. The availability of pretreatment susceptibility test results will provide a guide in selection of drugs in treating such cases.
185470|NCT01618422|O1|Outcome|DOTS Strategy|The standard regimen for treatment of new cases of pulmonary TB consists of 6 months treatment, with 4 drugs in the initial phase including isoniazid, rifampicin, pyrazinamide, and either ethambutol or streptomycin, followed by two drugs in the continuation phase including isoniazid and rifampicin. In the treatment of previously treated cases, a standard regimen consisting of 8 months treatment will be used.
185471|NCT01618422|E2|Reported Event|DOTS Plus|Directly Observed Therapy (DOTS) plus: The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and second-line drugs. The regimen used to treat MDR-TB comprises 5 to 6 drugs to which the organism is or likely to be susceptible for the initial 6 months, and then 3 to 4 drugs subsequently. In addition, TB cases with rifampicin resistance but not amounting to MDR-TB are also at risk of unfavourable treatment outcomes. The availability of pretreatment susceptibility test results will provide a guide in selection of drugs in treating such cases.
185472|NCT01618422|E1|Reported Event|DOTS Strategy|The DOTS strategy (current strategy) consists of the following measures: political commitment, case detection through bacteriologic evaluation, standardized treatment with supervision and patient support, an effective drug supply system, and a reporting and recording system that allows assessment of treatment. The standard regimen for treatment of new cases of pulmonary TB consists of 6 months treatment, with 4 drugs in the initial phase including isoniazid, rifampicin, pyrazinamide, and either ethambutol or streptomycin, followed by two drugs in the continuation phase including isoniazid and rifampicin (2HRZE/4HR or 2HRZS/4HR). In the treatment of previously treated cases, a standard regimen consisting of 8 months treatment will be used (2HRZES/1HRZE/5HRE).
185473|NCT01618344|B1|Baseline|Participants|All participants
185474|NCT01618344|P1|Participant Flow|Smart-phone Medication Reminder Application|All participants were provided with the medication reminder application, and were instructed on how to program the application based on their individual medication dosing schedules. At the scheduled times, the application prompted participants to take their medications.
185475|NCT01618344|O1|Outcome|Participants|All participants
185476|NCT01618344|E1|Reported Event|Participants|All participants
185477|NCT01618266|B1|Baseline|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
185478|NCT01618266|P1|Participant Flow|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
185479|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
185480|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
185481|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
185482|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
185483|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
185484|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
185487|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
185488|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
185489|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
185490|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
185491|NCT01618266|E1|Reported Event|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
185492|NCT01618240|B1|Baseline|Baseline Population|Thirty long-term ventilated patients admitted in two intensive care units at Massachusetts General Hospital.
185493|NCT01618240|P1|Participant Flow|Long-term Ventilated Subjects|Long-term (>10 days hours) ventilated subjects were included.
185494|NCT01618240|O1|Outcome|Muscle Strength Measurement|Muscle Strength Measurement : MRC score (0-60) is a clinical assessment of muscle power on abduction of the arm, flexion of the forearm, extension of the wrist, flexion of the leg, extension of the knee and dorsal flexion of the foot with the score of (0-5) on each measurement
185495|NCT01618240|O1|Outcome|Muscle Strength Measurement|Muscle Strength Measurement : MRC score (0-60) is a clinical assessment of muscle power on abduction of the arm, flexion of the forearm, extension of the wrist, flexion of the leg, extension of the knee and dorsal flexion of the foot with the score of (0-5) on each measurement
185496|NCT01618240|E1|Reported Event|Long-term Ventilated Subjects|30 consented long-term ventilated patients
185497|NCT01618227|B3|Baseline|Total|Total of all reporting groups
185498|NCT01618227|B2|Baseline|Rehabilitation Without Splinting|Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
185499|NCT01618227|B1|Baseline|Rehabilitation With Static Progressive Splinting|"Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.~Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer."
185500|NCT01618227|P2|Participant Flow|Rehabilitation Without Splinting|Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
185501|NCT01618227|P1|Participant Flow|Rehabilitation With Static Progressive Splinting|"Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.~Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer."
185502|NCT01618227|O2|Outcome|Rehabilitation Without Splinting|Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
185503|NCT01618227|O1|Outcome|Rehabilitation With Static Progressive Splinting|"Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.~Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer."
185504|NCT01618227|O2|Outcome|Rehabilitation Without Splinting|Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
185505|NCT01618227|O1|Outcome|Rehabilitation With Static Progressive Splinting|"Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.~Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer."
185506|NCT01618227|O2|Outcome|Rehabilitation Without Splinting|Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
185507|NCT01618227|O1|Outcome|Rehabilitation With Static Progressive Splinting|"Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.~Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer."
185508|NCT01618227|O2|Outcome|Rehabilitation Without Splinting|Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
186430|NCT01613417|O4|Outcome|Reader 2 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
185509|NCT01618227|O1|Outcome|Rehabilitation With Static Progressive Splinting|"Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.~Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer."
185510|NCT01618227|E2|Reported Event|Rehabilitation Without Splinting|Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
185511|NCT01618227|E1|Reported Event|Rehabilitation With Static Progressive Splinting|"Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.~Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer."
185512|NCT01618214|B3|Baseline|Total|Total of all reporting groups
185513|NCT01618214|B2|Baseline|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
185514|NCT01618214|B1|Baseline|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
185515|NCT01618214|P2|Participant Flow|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
185516|NCT01618214|P1|Participant Flow|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
185517|NCT01618214|O2|Outcome|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
185518|NCT01618214|O1|Outcome|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
185519|NCT01618214|O2|Outcome|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
185520|NCT01618214|O1|Outcome|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
185560|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
185561|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
185521|NCT01618214|O2|Outcome|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
185522|NCT01618214|O1|Outcome|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
185523|NCT01618214|O2|Outcome|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
185524|NCT01618214|O1|Outcome|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
185525|NCT01618214|O2|Outcome|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
185526|NCT01618214|O1|Outcome|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
185527|NCT01618214|E2|Reported Event|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
185528|NCT01618214|E1|Reported Event|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
185529|NCT01618162|B3|Baseline|Total|Total of all reporting groups
185530|NCT01618162|B2|Baseline|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
185531|NCT01618162|B1|Baseline|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
185562|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
185563|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
185564|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
194304|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
185532|NCT01618162|P2|Participant Flow|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
185533|NCT01618162|P1|Participant Flow|IDegLira|In this arm, subjects suboptimally controlled on sulfonyl urea (SU) +/- metformin, were given subcutenaous (s.c.) injection of insulin degludec/liraglutide (IDegLira). SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
185534|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
185535|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
185536|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
185537|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
185538|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
185539|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
185540|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
185541|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
185542|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
185543|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
185544|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
185545|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
185546|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
185547|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
185548|NCT01618162|E2|Reported Event|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
185549|NCT01618162|E1|Reported Event|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
185550|NCT01618019|B3|Baseline|Total|Total of all reporting groups
185551|NCT01618019|B2|Baseline|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
185552|NCT01618019|B1|Baseline|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
185553|NCT01618019|P2|Participant Flow|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
185554|NCT01618019|P1|Participant Flow|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
185555|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
185556|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
185557|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
185558|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
185559|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
185567|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
185568|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
185569|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
185570|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
185571|NCT01618019|E2|Reported Event|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
185572|NCT01618019|E1|Reported Event|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
185573|NCT01617681|B5|Baseline|Total|Total of all reporting groups
185574|NCT01617681|B4|Baseline|Non-CKD Patients Valsartan 4 mg/kg|Non-CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
185575|NCT01617681|B3|Baseline|Non-CKD Patients Valsartan 0.25 mg/kg|Non-CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
185576|NCT01617681|B2|Baseline|CKD Patients Valsartan 4 mg/kg|CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
185577|NCT01617681|B1|Baseline|CKD Patients Valsartan 0.25 mg/kg|CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
185578|NCT01617681|P5|Participant Flow|Valsartan 1 mg/kg (Period 2)|Open-label (Period 2) valsartan will be optionally titrated from 1 mg/kg to 2 mg/kg. Valsartan will continue to be optionally up titrated in 1 mg/kg increments every 4 weeks until maximum dose of 4 mg/kg is achieved. Duration 20 weeks.
185579|NCT01617681|P4|Participant Flow|Non-CKD Patients Valsartan 4 mg/kg|Non-CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
185580|NCT01617681|P3|Participant Flow|Non-CKD Patients Valsartan 0.25 mg/kg|Non-CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
185581|NCT01617681|P2|Participant Flow|CKD Patients Valsartan 4 mg/kg|CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
185582|NCT01617681|P1|Participant Flow|CKD Patients Valsartan 0.25 mg/kg|CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
185583|NCT01617681|O2|Outcome|CKD Patients Valsartan 4 mg/kg|CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
185584|NCT01617681|O1|Outcome|CKD Patients Valsartan 0.25 mg/kg|CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
185585|NCT01617681|O4|Outcome|Non-CKD Patients Valsartan 4 mg/kg|Non-CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
185586|NCT01617681|O3|Outcome|Non-CKD Patients Valsartan 0.25 mg/kg|Non-CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
185587|NCT01617681|O2|Outcome|CKD Patients Valsartan 4 mg/kg|CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
185588|NCT01617681|O1|Outcome|CKD Patients Valsartan 0.25 mg/kg|CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
185589|NCT01617681|O4|Outcome|Non-CKD Patients Valsartan 4 mg/kg|Non-CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
185590|NCT01617681|O3|Outcome|Non-CKD Patients Valsartan 0.25 mg/kg|Non-CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
185591|NCT01617681|O2|Outcome|CKD Patients Valsartan 4 mg/kg|CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
185592|NCT01617681|O1|Outcome|CKD Patients Valsartan 0.25 mg/kg|CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
185593|NCT01617681|O4|Outcome|Non-CKD Patients Valsartan 4 mg/kg|Non-CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
185594|NCT01617681|O3|Outcome|Non-CKD Patients Valsartan 0.25 mg/kg|Non-CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
185595|NCT01617681|O2|Outcome|CKD Patients Valsartan 4 mg/kg|CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
185596|NCT01617681|O1|Outcome|CKD Patients Valsartan 0.25 mg/kg|CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
185597|NCT01617681|E3|Reported Event|All Open Label Patients|Open-label (Period 2) valsartan will be optionally titrated from 1 mg/kg to 2 mg/kg. Valsartan will continue to be optionally up titrated in 1 mg/kg increments every 4 weeks until maximum dose of 4 mg/kg is achieved. Duration 20 weeks.
185598|NCT01617681|E2|Reported Event|Valsartan 4.0 mg/kg|All Patients CKD & Non-CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
185599|NCT01617681|E1|Reported Event|Valsartan 0.25 mg/kg|All Patients CKD & Non-CKD: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
185600|NCT01617668|B3|Baseline|Total|Total of all reporting groups
185654|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
186431|NCT01613417|O3|Outcome|Reader 2 - ProHance|MRI after ProHance 0.1 mmol/kg
185601|NCT01617668|B2|Baseline|Paclitaxel Without LCL161|Patients randomized to the control arm received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185602|NCT01617668|B1|Baseline|Paclitaxel With LCL161|Patients randomized to the experimental arm received paclitaxel 80 mg/m2 weekly + LECL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185603|NCT01617668|P4|Participant Flow|Paclitaxel Without LCL161 (Negative Group)|Patients randomized to the control arm received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185604|NCT01617668|P3|Participant Flow|Paclitaxel With LCL161 (Negative Group)|Patients randomized to the experimental arm received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185605|NCT01617668|P2|Participant Flow|Paclitaxel Without LCL161 (Positive Group)|Patients randomized to the control arm received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185606|NCT01617668|P1|Participant Flow|Paclitaxel With LCL161 (Positive Group)|Patients randomized to the experimental arm received paclitaxel 80 mg/m2 weekly + LECL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185607|NCT01617668|O1|Outcome|LCL161|Patients randomized to the LCL161 1800 mg once weekly for 12 weeks.
185608|NCT01617668|O1|Outcome|LCL161|Patients randomized to the LCL161 1800 mg once weekly for 12 weeks.
185609|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185610|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185611|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185612|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185613|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185614|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185615|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185616|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185617|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185618|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185619|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185620|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185621|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185622|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185623|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
186432|NCT01613417|O2|Outcome|Reader 1 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
185624|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185625|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185626|NCT01617668|O2|Outcome|Paclitaxel Only|Patients randomized to the control arm who received paclitaxel 80 mg/m2 weekly for 12 weeks.
185627|NCT01617668|O1|Outcome|LCL161 + Paclitaxel|Patients randomized to the experimental arm received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks.
185628|NCT01617668|O1|Outcome|Paclitaxel Only|Patients randomized to the control arm who received paclitaxel 80 mg/m2 weekly for 12 weeks.
185629|NCT01617668|O1|Outcome|LCL161 + Paclitaxel|Patients randomized to the experimental arm who received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks.
185630|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185631|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185632|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185633|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185634|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185635|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185636|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185637|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185638|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185639|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185640|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185641|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185642|NCT01617668|E2|Reported Event|PACLITAXEL|Patients randomized to the control arm for gene expression signature positive/negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185643|NCT01617668|E1|Reported Event|LCL161+PACLITAXEL|Patients randomized to the experimental arm for gene expression signature positive/negative received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
185644|NCT01617655|B3|Baseline|Total|Total of all reporting groups
185645|NCT01617655|B2|Baseline|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185646|NCT01617655|B1|Baseline|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
185647|NCT01617655|P2|Participant Flow|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185648|NCT01617655|P1|Participant Flow|Placebo Q2W|Placebo for alirocumab subcutaneous (SC) injection every two weeks (Q2W) on top of stable lipid-modifying therapy (LMT) for 78 weeks.
185649|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185650|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
185651|NCT01617655|O2|Outcome|Alirocumab 150 Q2W|Participants exposed to Alirocumab 150 mg Q2W on top of stable LMT (mean exposure of 78 weeks).
194305|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
185659|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185660|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
185661|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185662|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
185663|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185664|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
185665|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185666|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
185667|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185668|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
185669|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185670|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
185671|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185672|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
185673|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185674|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
185675|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185676|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
185677|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185678|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
185679|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185680|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
185681|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185682|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
185683|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185684|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
185685|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185686|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
185687|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185688|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
185689|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185690|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
185691|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185692|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
185693|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185694|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
185695|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185696|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
185697|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185698|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
185699|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185700|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
185701|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185702|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
185703|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
185704|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
185705|NCT01617655|E2|Reported Event|Alirocumab 150 Q2W|Participants exposed to Alirocumab 150 mg Q2W on top of stable LMT (mean exposure of 68 weeks).
185706|NCT01617655|E1|Reported Event|Placebo Q2W|Participants exposed to placebo Q2W on top of stable LMT (mean exposure of 71 weeks).
185707|NCT01617629|B1|Baseline|Cvac Treatment Group|"Participants received MUC1 Dendritic Cell Vaccine (Cvac) treatment.~MUC1 Dendritic Cell Vaccine (Cvac): The recommended dosing regimen for CAN-003X was every 4 weeks for the first 3 doses and then every 12 weeks for 3 doses, for a total of 6 doses over 44 weeks (Regimen A, applicable to CAN-003 observational Standard of Care patients and CAN-003 Cvac patients that have progressed prior to the fourth dose of Cvac).~Participants who received more than 3 doses of Cvac in CAN-003 continued with the CAN-003 dosing schedule (Regimen B; Cvac every 4 weeks for a total of 7 doses and then every 8 weeks for 3 doses, for a total of 10 doses over approximately 48 weeks)."
185727|NCT01617577|B1|Baseline|G-CSF First Phase|Subjects assigned to this arm receive G-CSF for 5 days during the first phase of the study. At week 7 these subjects cross over to receive placebo injections for five days
185708|NCT01617629|P1|Participant Flow|Cvac Treatment Group|"Participants received Epithelial Mucin Surface Antigen 1 (MUC1) Dendritic Cell Vaccine (Cvac) treatment.~MUC1 Dendritic Cell Vaccine (Cvac): The recommended dosing regimen for CAN-003X was every 4 weeks for the first 3 doses and then every 12 weeks for 3 doses, for a total of 6 doses over 44 weeks (Regimen A, applicable to CAN-003 observational Standard of Care patients and CAN-003 Cvac patients that have progressed prior to the fourth dose of Cvac).~Participants who received more than 3 doses of Cvac in CAN-003 continued with the CAN-003 dosing schedule (Regimen B; Cvac every 4 weeks for a total of 7 doses and then every 8 weeks for 3 doses, for a total of 10 doses over approximately 48 weeks)."
185709|NCT01617629|O1|Outcome|Cvac Treatment Group|"Participants received MUC1 Dendritic Cell Vaccine (Cvac) treatment.~MUC1 Dendritic Cell Vaccine (Cvac): The recommended dosing regimen for CAN-003X was every 4 weeks for the first 3 doses and then every 12 weeks for 3 doses, for a total of 6 doses over 44 weeks (Regimen A, applicable to CAN-003 observational Standard of Care patients and CAN-003 Cvac patients that have progressed prior to the fourth dose of Cvac).~Participants who received more than 3 doses of Cvac in CAN-003 continued with the CAN-003 dosing schedule (Regimen B; Cvac every 4 weeks for a total of 7 doses and then every 8 weeks for 3 doses, for a total of 10 doses over approximately 48 weeks)."
185710|NCT01617629|O1|Outcome|Cvac Treatment Group|"Participants received MUC1 Dendritic Cell Vaccine (Cvac) treatment.~MUC1 Dendritic Cell Vaccine (Cvac): The recommended dosing regimen for CAN-003X was every 4 weeks for the first 3 doses and then every 12 weeks for 3 doses, for a total of 6 doses over 44 weeks (Regimen A, applicable to CAN-003 observational Standard of Care patients and CAN-003 Cvac patients that have progressed prior to the fourth dose of Cvac).~Participants who received more than 3 doses of Cvac in CAN-003 continued with the CAN-003 dosing schedule (Regimen B; Cvac every 4 weeks for a total of 7 doses and then every 8 weeks for 3 doses, for a total of 10 doses over approximately 48 weeks)."
185711|NCT01617629|E1|Reported Event|Cvac Treatment Group|"Participants received MUC1 Dendritic Cell Vaccine (Cvac) treatment.~MUC1 Dendritic Cell Vaccine (Cvac): The recommended dosing regimen for CAN-003X was every 4 weeks for the first 3 doses and then every 12 weeks for 3 doses, for a total of 6 doses over 44 weeks (Regimen A, applicable to CAN-003 observational Standard of Care patients and CAN-003 Cvac patients that have progressed prior to the fourth dose of Cvac).~Participants who received more than 3 doses of Cvac in CAN-003 continued with the CAN-003 dosing schedule (Regimen B; Cvac every 4 weeks for a total of 7 doses and then every 8 weeks for 3 doses, for a total of 10 doses over approximately 48 weeks)."
185712|NCT01617603|B4|Baseline|Total|Total of all reporting groups
185713|NCT01617603|B3|Baseline|Nestle Noir 70 % Chocolate|"Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
185714|NCT01617603|B2|Baseline|Low Polyphenol Milk|"Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin.~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
185715|NCT01617603|B1|Baseline|High Polyphenol Milk Chocolate|"High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
185716|NCT01617603|P3|Participant Flow|Nestle Noir 70 % Chocolate|"Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
185717|NCT01617603|P2|Participant Flow|Low Polyphenol Milk|"Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin.~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
185718|NCT01617603|P1|Participant Flow|High Polyphenol Milk Chocolate|"High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
185719|NCT01617603|O3|Outcome|Nestle Noir 70 % Chocolate|"Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
185720|NCT01617603|O2|Outcome|Low Polyphenol Milk|"Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin.~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
185721|NCT01617603|O1|Outcome|High Polyphenol Milk Chocolate|"High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
185722|NCT01617603|E3|Reported Event|Nestle Noir 70 % Chocolate|"Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
185723|NCT01617603|E2|Reported Event|Low Polyphenol Milk|"Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin.~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
185724|NCT01617603|E1|Reported Event|High Polyphenol Milk Chocolate|"High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
185725|NCT01617577|B3|Baseline|Total|Total of all reporting groups
185726|NCT01617577|B2|Baseline|Placebo First Phase|Subjects assigned to this arm receive placebo injections daily for 5 days; after wk 7 they crossover to receive 5 daily injections of injections of G-CSF.
194306|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
185728|NCT01617577|P2|Participant Flow|Placebo First Phase|Subjects assigned to this arm receive placebo injections daily for 5 days; after wk 7 they crossover to receive 5 daily injections of injections of G-CSF.
185729|NCT01617577|P1|Participant Flow|G-CSF First Phase|Subjects assigned to this arm receive G-CSF for 5 days during the first phase of the study. At week 7 these subjects cross over to receive placebo injections for five days
185730|NCT01617577|O1|Outcome|G-CSF and Placebo|All participants received G-CSF and placebo in crossover order
185731|NCT01617577|O2|Outcome|Placebo|All participants received placebo either in the first or second phase of crossover
185732|NCT01617577|O1|Outcome|G-CSF|All participants received G-CSF either in the first or second phase of the crossover
185733|NCT01617577|E2|Reported Event|G-CSF|participants who received GCSF injecitons during first or second phase
185734|NCT01617577|E1|Reported Event|Placebo|subjects who received placebo in either phase of the study
185735|NCT01617460|B1|Baseline|Aripiprazole|"Aripiprazole was orally administered once daily to the subjects who completed the 031-11-002 study until the new indication of irritability in pediatric autistic disorder was approved, if not discontinued.~The starting dose was 1 mg/day, and the dose was escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner."
185736|NCT01617460|P1|Participant Flow|Aripiprazole|"Aripiprazole was orally administered once daily to the subjects who completed the 031-11-002 study until the new indication of irritability in pediatric autistic disorder was approved, if not discontinued.~The starting dose was 1 mg/day, and the dose was escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner."
185737|NCT01617460|O1|Outcome|Aripiprazole|"Aripiprazole was orally administered once daily to the subjects who completed the 031-11-002 study until the new indication of irritability in pediatric autistic disorder was approved, if not discontinued.~The starting dose was 1 mg/day, and the dose was escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner."
185738|NCT01617460|E1|Reported Event|Aripiprazole|"Aripiprazole was orally administered once daily to the subjects who completed the 031-11-002 study until the new indication of irritability in pediatric autistic disorder was approved, if not discontinued.~The starting dose was 1 mg/day, and the dose was escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner."
185739|NCT01617447|B3|Baseline|Total|Total of all reporting groups
185740|NCT01617447|B2|Baseline|Placebo|Placebo were orally administered once daily for 8 weeks.
185741|NCT01617447|B1|Baseline|Aripiprazole|Aripiprazole were orally administered once daily for 8 weeks. The starting dose was 1 mg/day, and the dose will be escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8.
185742|NCT01617447|P2|Participant Flow|Placebo|Placebo were orally administered once daily for 8 weeks.
185743|NCT01617447|P1|Participant Flow|Aripiprazole|Aripiprazole were orally administered once daily for 8 weeks. The starting dose was 1 mg/day, and the dose will be escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8.
185744|NCT01617447|O2|Outcome|Placebo|Placebo were orally administered once daily for 8 weeks.
185745|NCT01617447|O1|Outcome|Aripiprazole|Aripiprazole were orally administered once daily for 8 weeks. The starting dose was 1 mg/day, and the dose will be escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8.
185746|NCT01617447|E2|Reported Event|Placebo|Placebo were orally administered once daily for 8 weeks.
185747|NCT01617447|E1|Reported Event|Aripiprazole|Aripiprazole were orally administered once daily for 8 weeks. The starting dose was 1 mg/day, and the dose will be escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8.
185748|NCT01617434|B3|Baseline|Total|Total of all reporting groups
185749|NCT01617434|B2|Baseline|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
185750|NCT01617434|B1|Baseline|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
185751|NCT01617434|P2|Participant Flow|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
185752|NCT01617434|P1|Participant Flow|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
185776|NCT01617369|O1|Outcome|Acute Hypertonic Saline Effect|"2.8% NaCl inhaled 30 minutes before MCC scan performed~Hypertonic Saline: 2.8% NaCl x 4ml via Pari LC STAR jet nebulizer"
185753|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
185754|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
185755|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
185756|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
185757|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
185758|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
185759|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
185760|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
185761|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
185762|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
185777|NCT01617369|E2|Reported Event|Sustained Hypertonic Saline Effect|"2.8% NaCl inhaled 4 hours before Mucociliary Clearance measured.~Hypertonic Saline: 2.8% NaCl x 4ml via nebulizer"
185778|NCT01617369|E1|Reported Event|Acute Hypertonic Saline Effect|"2.8% NaCl inhaled 30 minutes before Mucociliary Clearance measured.~Hypertonic Saline: 2.8% NaCl x 4ml via nebulizer"
185779|NCT01617187|B5|Baseline|Total|Total of all reporting groups
185763|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
185764|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
185765|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
185766|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
185767|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
185768|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
185769|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
185770|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
185771|NCT01617434|E2|Reported Event|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
185772|NCT01617434|E1|Reported Event|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
185773|NCT01617369|B1|Baseline|Hypertonic Saline|"2.8% NaCl~Hypertonic Saline: 2.8% NaCl x 4ml via nebulizer"
185774|NCT01617369|P1|Participant Flow|Hypertonic Saline|"2.8% NaCl~Hypertonic Saline: 2.8% NaCl x 4ml via nebulizer"
185775|NCT01617369|O2|Outcome|Sustained Hypertonic Saline Effect|"2.8% NaCl Inhaled 4 hours before mucociliary clearance measured~Hypertonic saline = 2.8% NaCl x 4 ml delivered via Pari LC STAR jet nebulizer"
185781|NCT01617187|B3|Baseline|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
185782|NCT01617187|B2|Baseline|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
185783|NCT01617187|B1|Baseline|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
185784|NCT01617187|P4|Participant Flow|Placebo BID|Participants were administered placebo tablets BID for 42 days
185785|NCT01617187|P3|Participant Flow|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) once daily (QD) for 42 days, except during Week 1 olanzapine 10 mg QD was administered
185786|NCT01617187|P2|Participant Flow|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
185787|NCT01617187|P1|Participant Flow|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet twice daily (BID) for 42 days
185788|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
185789|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
185790|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
185791|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
185792|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
185793|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
185794|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
185795|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
185796|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
185797|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
185798|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
185799|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
185800|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
185801|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
185802|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
185803|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
185804|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
185805|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
185806|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
185807|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
185808|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
185809|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
185810|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
185811|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
185812|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
185813|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
185814|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
185815|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
185816|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
185817|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
185818|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
185819|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
185820|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
185821|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
185822|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
185823|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
185824|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
185825|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
185826|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
185827|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
185828|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
185829|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
185830|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
185831|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
185832|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
185833|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
185834|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
185835|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
185836|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
185837|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
185838|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
185839|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
185840|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
185841|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
185842|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
185843|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
185844|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
185845|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
185846|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
185847|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
185848|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
185849|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
185850|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
185851|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
185852|NCT01617187|E4|Reported Event|Placebo BID|Participants were administered placebo tablets BID for 42 days
185853|NCT01617187|E3|Reported Event|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
185854|NCT01617187|E2|Reported Event|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
185855|NCT01617187|E1|Reported Event|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
185856|NCT01617083|B4|Baseline|Total|Total of all reporting groups
185857|NCT01617083|B3|Baseline|Not Randomized|Participants only completed the baseline assessments but did not receive treatment.
185858|NCT01617083|B2|Baseline|Placebo|"Compound thickening agent with sugar and flavor additives.~Placebo: Thickening compound with sugar and flavoring"
185859|NCT01617083|B1|Baseline|Azithromycin|"Antibiotic used to treat infections.~Azithromycin: Antibiotic used to treat infections"
185860|NCT01617083|P3|Participant Flow|Not Randomized|Participants consented to participate in the study. They completed baseline assessments but did not randomize to treatment.
185861|NCT01617083|P2|Participant Flow|Placebo|"Compound thickening agent with sugar and flavor additives.~Placebo: Thickening compound with sugar and flavoring"
185862|NCT01617083|P1|Participant Flow|Azithromycin|"Antibiotic used to treat infections.~Azithromycin: Antibiotic used to treat infections"
185863|NCT01617083|O2|Outcome|Placebo|"Compound thickening agent with sugar and flavor additives.~Placebo: Thickening compound with sugar and flavoring"
185864|NCT01617083|O1|Outcome|Azithromycin|"Antibiotic used to treat infections.~Azithromycin: Antibiotic used to treat infections"
185865|NCT01617083|O3|Outcome|Not Randomized|Participants consented to participate in the study. They completed baseline assessments but did not randomize to treatment.
185866|NCT01617083|O2|Outcome|Placebo|"Compound thickening agent with sugar and flavor additives.~Placebo: Thickening compound with sugar and flavoring"
185867|NCT01617083|O1|Outcome|Azithromycin|"Antibiotic used to treat infections.~Azithromycin: Antibiotic used to treat infections"
185868|NCT01617083|O2|Outcome|Placebo|"Compound thickening agent with sugar and flavor additives.~Placebo: Thickening compound with sugar and flavoring"
185869|NCT01617083|O1|Outcome|Azithromycin|"Antibiotic used to treat infections.~Azithromycin: Antibiotic used to treat infections"
185870|NCT01617083|E2|Reported Event|Placebo|This group was assigned to receive placebo (compound thickening agent with sugar and flavor additives - not active treatment).
185871|NCT01617083|E1|Reported Event|Azithromycin|This group was assigned to receive azithromycin (antibiotic).
185872|NCT01617070|B1|Baseline|All Study Participants|"LNAA, washout, Kuvan, and LNAA+Kuvan~One group of 10 subjects, each under 4 conditions (each phase is 4 weeks)~Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
185873|NCT01617070|P1|Participant Flow|All Study Participants|"LNAA, washout, Kuvan, and LNAA+Kuvan~One group of 10 subjects, each under 4 conditions (each phase is 4 weeks)~Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
194307|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
185874|NCT01617070|O4|Outcome|BH4 and LNAA|"Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
185875|NCT01617070|O3|Outcome|BH4 (Kuvan)|Kuvan (BH4): Dosed at 20 mg/kg; PO; Phase 3, Phase 4
185876|NCT01617070|O2|Outcome|Washout|no Kuvan or LNAA or any medical food products. Limited protein intake diet.
185877|NCT01617070|O1|Outcome|LNAA|"LNAA~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
185878|NCT01617070|O4|Outcome|BH4 and LNAA|"Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
185879|NCT01617070|O3|Outcome|BH4 (Kuvan)|Kuvan (BH4): Dosed at 20 mg/kg; PO; Phase 3, Phase 4
185880|NCT01617070|O2|Outcome|Washout|no Kuvan or LNAA or any medical food products. Limited protein intake diet.
185881|NCT01617070|O1|Outcome|LNAA|"LNAA~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
185882|NCT01617070|O4|Outcome|BH4 and LNAA|"Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
185883|NCT01617070|O3|Outcome|BH4 (Kuvan)|Kuvan (BH4): Dosed at 20 mg/kg; PO; Phase 3, Phase 4
185884|NCT01617070|O2|Outcome|Washout|no Kuvan or LNAA or any medical food products. Limited protein intake diet.
185885|NCT01617070|O1|Outcome|LNAA|"LNAA~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
185886|NCT01617070|E4|Reported Event|BH4 and LNAA|"Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
185887|NCT01617070|E3|Reported Event|BH4 (Kuvan)|Kuvan (BH4): Dosed at 20 mg/kg; PO; Phase 3, Phase 4
185888|NCT01617070|E2|Reported Event|Washout|no Kuvan or LNAA or any medical food products. Limited protein intake diet.
185889|NCT01617070|E1|Reported Event|LNAA|"LNAA~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
185890|NCT01617005|B1|Baseline|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
185891|NCT01617005|P1|Participant Flow|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active Rheumatoid Arthritis (RA) participants, receiving tocilizumab treatment according to effective official Summary of Product Characteristics (SPC), were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
185892|NCT01617005|O1|Outcome|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
185893|NCT01617005|O1|Outcome|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
185894|NCT01617005|O1|Outcome|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
185895|NCT01617005|O1|Outcome|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
185896|NCT01617005|E1|Reported Event|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
185897|NCT01616953|B3|Baseline|Total|Total of all reporting groups
185898|NCT01616953|B2|Baseline|Autogenous Bone Grafting|"Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.~Autogenous Bone Grafting: Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care."
185899|NCT01616953|B1|Baseline|Ixmyelocel-T|"iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation. Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.~Ixmyelocel-T: Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)"
186065|NCT01615939|E1|Reported Event|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).~Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
186066|NCT01615822|B4|Baseline|Total|Total of all reporting groups
185900|NCT01616953|P2|Participant Flow|Autogenous Bone Grafting|"Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.~Autogenous Bone Grafting: Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care."
185901|NCT01616953|P1|Participant Flow|Ixmyelocel-T|"iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation. Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.~Ixmyelocel-T: Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)"
185902|NCT01616953|O2|Outcome|Autogenous Bone Grafting|"Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.~Autogenous Bone Grafting: Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care."
185903|NCT01616953|O1|Outcome|Ixmyelocel-T|"iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation. Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.~Ixmyelocel-T: Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)"
185904|NCT01616953|O2|Outcome|Autogenous Bone Grafting|"Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.~Autogenous Bone Grafting: Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care."
185905|NCT01616953|O1|Outcome|Ixmyelocel-T|"iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation. Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.~Ixmyelocel-T: Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)"
185906|NCT01616953|E2|Reported Event|Autogenous Bone Grafting|"Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.~Autogenous Bone Grafting: Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care."
185907|NCT01616953|E1|Reported Event|Ixmyelocel-T|"iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation. Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.~Ixmyelocel-T: Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)"
185908|NCT01616771|B1|Baseline|Glottis View Assessment|After checking the C&L grade using Macintosh laryngoscope, C&L grade was re-evaluated using GVL selected by weight and smaller sized GVL in consecutive order.
185909|NCT01616771|P1|Participant Flow|Glottis View Assessment|After checking the C&L grade using Macintosh laryngoscope, C&L grade was re-evaluated using GVL selected by weight and smaller sized GVL in consecutive order.
185910|NCT01616771|O2|Outcome|Smaller Sized GVL|The C&L grade was reassessed by smaller sized GVL, after removal of GVL selected by weight
185911|NCT01616771|O1|Outcome|GVL Selected by Weight|Right after Macintosh laryngoscope was removed, C&L grade was reassessed by second laryngoscopy, using GVL selected by weight.
185912|NCT01616771|O2|Outcome|GVL Selected by Weight|Right after Macintosh laryngoscope was removed, C&L grade was reassessed by second laryngoscopy, using GVL selected by weight.
185913|NCT01616771|O1|Outcome|Macintosh Laryngoscope|After induction of anesthesia, Macintosh laryngoscope was inserted into mouth and C&L grade was checked.
185914|NCT01616771|E3|Reported Event|Smaller Sized GVL|C&L grade assessment by smaller sized GVL, after removal of GVL selected by weight
185915|NCT01616771|E2|Reported Event|GVL Selected by Weight|C&L grade assessment by GVL selected by weight, after removal of Macintosh laryngoscope
185916|NCT01616771|E1|Reported Event|Macintosh Laryngoscope|C&L grade assessment by Macintosh laryngoscope, after induction of anesthesia
185917|NCT01616576|B3|Baseline|Total|Total of all reporting groups
185918|NCT01616576|B2|Baseline|Experimental First, Then Control (Group B)|"Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of Control Sound Processing Strategy for the second week.~Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
185919|NCT01616576|B1|Baseline|Control First, Then Experimental (Group A)|"Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week.~Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
185920|NCT01616576|P2|Participant Flow|Experimental First, Then Control (Group B)|"Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of Control Sound Processing Strategy for the second week.~Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
185921|NCT01616576|P1|Participant Flow|Control First, Then Experimental (Group A)|"Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week.~Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
185922|NCT01616576|O2|Outcome|Experimental First, Then Control (Group B)|"Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of Control Sound Processing Strategy for the second week.~Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
185923|NCT01616576|O1|Outcome|Control First, Then Experimental (Group A)|"Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week.~Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
185924|NCT01616576|O3|Outcome|Experimental|Data from Group A and Group B were pooled for the statistical analyses. Experimental data consisted of Week 2 data from Group A and Week 1 data from Group B.
185925|NCT01616576|O2|Outcome|Control|Data from Group A and Group B were pooled for the statistical analyses. Control data consists of Week 1 data from Group A and Week 2 data from Group B.
185926|NCT01616576|O1|Outcome|Group A and Group B Data Pooled|Data from Group A (n=18) and Group B (n=18) were pooled for the statistical analyses. Control data consists of Week 1 data from Group A and Week 2 data from Group B; Experimental data consisted of Week 2 data from Group A and Week 1 data from Group B. The resulting mean Control score was subtracted from the mean Experimental score to yield a paired difference score (i.e. Experimental - Control = paired difference score). The paired difference score (n=36) is reported below for each listening condition.
185927|NCT01616576|E2|Reported Event|Experimental First, Then Control (Group B)|"Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of the Control Sound Processing Strategy for the second week.~Control Sound Processing Strategy: HiRes Fidelity 120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
185928|NCT01616576|E1|Reported Event|Control First, Then Experimental (Group A)|"Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System condition for the second week.~Control Sound Processing Strategy: HiRes Fidelity 120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
185929|NCT01616459|B5|Baseline|Total|Total of all reporting groups
185930|NCT01616459|B4|Baseline|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
185931|NCT01616459|B3|Baseline|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185932|NCT01616459|B2|Baseline|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186067|NCT01615822|B3|Baseline|Placebo|Placebo
186433|NCT01613417|O1|Outcome|Reader 1 - ProHance|MRI after ProHance 0.1 mmol/kg
185933|NCT01616459|B1|Baseline|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185934|NCT01616459|P4|Participant Flow|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185935|NCT01616459|P3|Participant Flow|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185936|NCT01616459|P2|Participant Flow|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185937|NCT01616459|P1|Participant Flow|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185938|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185939|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185940|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186054|NCT01615939|B2|Baseline|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.~Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
186434|NCT01613417|O3|Outcome|Reader 3|Lesions reviewed by Reader 3
185941|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185942|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185943|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185944|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185945|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185946|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185947|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185948|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186055|NCT01615939|B1|Baseline|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).~Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
186068|NCT01615822|B2|Baseline|Cohort 2|"Period 1: OZ439 400mg single dose oral suspension~Period 2: Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets"
186069|NCT01615822|B1|Baseline|Cohort 1|"Period 1: OZ439 100mg single dose oral suspension~Period 2: Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet"
185949|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185950|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185951|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185952|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185953|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185954|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185955|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185956|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186056|NCT01615939|P2|Participant Flow|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.~Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
186070|NCT01615822|P3|Participant Flow|Placebo|Placebo
185957|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185958|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
185959|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185960|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185961|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185962|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185963|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185964|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186057|NCT01615939|P1|Participant Flow|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).~Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
186071|NCT01615822|P2|Participant Flow|Cohort 2|"Period 1: OZ439 400mg single dose oral suspension~Period 2: Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets"
186120|NCT01615484|P2|Participant Flow|Lung Transplant From Conventional Brain-dead Organ Donor|No experimental procedures will be carried out.
185965|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185966|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
185967|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185968|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185969|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185970|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185971|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185972|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186058|NCT01615939|O2|Outcome|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.~Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
186370|NCT01614457|O1|Outcome|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
185973|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185974|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
185975|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185976|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185977|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185978|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185979|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185980|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186059|NCT01615939|O1|Outcome|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).~Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
186072|NCT01615822|P1|Participant Flow|Cohort 1|"Period 1: OZ439 100mg single dose oral suspension~Period 2: Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet"
186073|NCT01615822|O2|Outcome|OZ439 400mg Plus MQ 750mg Single Doses|Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets
185981|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185982|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
185983|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185984|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185985|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185986|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185987|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185988|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186060|NCT01615939|O2|Outcome|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.~Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
186371|NCT01614457|O2|Outcome|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
185989|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185990|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
185991|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185992|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185993|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185994|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185995|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185996|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186061|NCT01615939|O1|Outcome|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).~Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
186074|NCT01615822|O1|Outcome|OZ439 100mg Plus MQ 250mg Single Doses|Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet
186075|NCT01615822|O2|Outcome|OZ439 400mg Plus MQ 750mg Single Doses|Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets
185997|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185998|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
185999|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186000|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186001|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186002|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186003|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186004|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186062|NCT01615939|O2|Outcome|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.~Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
186372|NCT01614457|O1|Outcome|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
186005|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186006|NCT01616459|O2|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186007|NCT01616459|O1|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186008|NCT01616459|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186009|NCT01616459|O1|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186010|NCT01616459|O2|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186011|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186012|NCT01616459|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186063|NCT01615939|O1|Outcome|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).~Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
186076|NCT01615822|O1|Outcome|OZ439 100mg Plus MQ 250mg Single Doses|Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet
186119|NCT01615484|B1|Baseline|Ex-vivo Lung Perfusion With STEEN Solution™|Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan.
186013|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186014|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
186015|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186016|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186017|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186018|NCT01616459|E4|Reported Event|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
186019|NCT01616459|E3|Reported Event|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186020|NCT01616459|E2|Reported Event|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186064|NCT01615939|E2|Reported Event|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.~Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
186373|NCT01614457|O2|Outcome|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
186021|NCT01616459|E1|Reported Event|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
186022|NCT01616173|B4|Baseline|Total|Total of all reporting groups
186023|NCT01616173|B3|Baseline|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
186024|NCT01616173|B2|Baseline|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
186025|NCT01616173|B1|Baseline|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
186026|NCT01616173|P3|Participant Flow|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
186027|NCT01616173|P2|Participant Flow|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
186028|NCT01616173|P1|Participant Flow|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
186029|NCT01616173|O3|Outcome|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
186030|NCT01616173|O2|Outcome|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
186031|NCT01616173|O1|Outcome|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
186032|NCT01616173|O3|Outcome|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
186033|NCT01616173|O2|Outcome|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
186034|NCT01616173|O1|Outcome|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
186035|NCT01616173|O3|Outcome|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
186036|NCT01616173|O2|Outcome|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
186037|NCT01616173|O1|Outcome|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
186038|NCT01616173|E3|Reported Event|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
186039|NCT01616173|E2|Reported Event|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
186040|NCT01616173|E1|Reported Event|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
186041|NCT01616056|B1|Baseline|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
186042|NCT01616056|P1|Participant Flow|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
186043|NCT01616056|O1|Outcome|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
186044|NCT01616056|O1|Outcome|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
186045|NCT01616056|O1|Outcome|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
186046|NCT01616056|O1|Outcome|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
186047|NCT01616056|O1|Outcome|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
186048|NCT01616056|O1|Outcome|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
186049|NCT01616056|O1|Outcome|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
186050|NCT01616056|O1|Outcome|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
186051|NCT01616056|O1|Outcome|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
186052|NCT01616056|E1|Reported Event|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
186053|NCT01615939|B3|Baseline|Total|Total of all reporting groups
186118|NCT01615484|B2|Baseline|Lung Transplant From Conventional Brain-dead Organ Donor|No experimental procedures will be carried out.
186077|NCT01615822|O4|Outcome|OZ439 400mg Plus MQ 750mg Single Doses|"Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets~OZ439 400mg: OZ439 400mg oral suspension, single dose~MQ 750mg, single dose: Mefloquine 750mg oral tablet, single dose"
186078|NCT01615822|O3|Outcome|OZ439 400mg Single Dose|"OZ439 400mg single dose oral suspension~OZ439 400mg: OZ439 400mg oral suspension, single dose"
186079|NCT01615822|O2|Outcome|OZ439 100mg Plus MQ 250mg Single Doses|"Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet~OZ439 100mg: OZ439 100mg oral suspension, single dose~MQ 250 mg, single dose: Mefloquine 250 mg tablet, single dose"
186080|NCT01615822|O1|Outcome|OZ439 100mg Single Dose|"OZ439 100mg single dose oral suspension~OZ439 100mg: OZ439 100mg oral suspension, single dose"
186081|NCT01615822|O4|Outcome|OZ439 400mg Plus MQ 750mg Single Doses|"Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets~OZ439 400mg: OZ439 400mg oral suspension, single dose~MQ 750mg, single dose: Mefloquine 750mg oral tablet, single dose"
186082|NCT01615822|O3|Outcome|OZ439 400mg Single Dose|"OZ439 400mg single dose oral suspension~OZ439 400mg: OZ439 400mg oral suspension, single dose"
186083|NCT01615822|O2|Outcome|OZ439 100mg Plus MQ 250mg Single Doses|"Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet~OZ439 100mg: OZ439 100mg oral suspension, single dose~MQ 250 mg, single dose: Mefloquine 250 mg tablet, single dose"
186084|NCT01615822|O1|Outcome|OZ439 100mg Single Dose|"OZ439 100mg single dose oral suspension~OZ439 100mg: OZ439 100mg oral suspension, single dose"
186085|NCT01615822|E3|Reported Event|Placebo|Placebo
186086|NCT01615822|E2|Reported Event|Cohort 2|"Period 1: OZ439 400mg single dose oral suspension~Period 2: Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets"
186087|NCT01615822|E1|Reported Event|Cohort 1|"Period 1: OZ439 100mg single dose oral suspension~Period 2: Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet"
186088|NCT01615809|B1|Baseline|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).~﻿AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization was 10 ml (50 mg) twice a week for the first week, and then from the second week onwards was reduced to 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count demonstrated to be greater than or equal to 1500 cells/mm3."
186089|NCT01615809|P1|Participant Flow|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).~﻿AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3."
186090|NCT01615809|O1|Outcome|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).~﻿AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3."
186091|NCT01615809|O1|Outcome|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).~﻿AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3."
186092|NCT01615809|O1|Outcome|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).~﻿AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3."
186093|NCT01615809|E1|Reported Event|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).~﻿AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3."
186094|NCT01615731|B3|Baseline|Total|Total of all reporting groups
186095|NCT01615731|B2|Baseline|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
186096|NCT01615731|B1|Baseline|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
186435|NCT01613417|O2|Outcome|Reader 2|Lesions reviewed by Reader 2
186097|NCT01615731|P2|Participant Flow|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
186098|NCT01615731|P1|Participant Flow|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
186099|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
186100|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
186101|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
186102|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
186103|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
186104|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
186105|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
186106|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
186107|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
186108|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
186109|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
186110|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
186111|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
186112|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
186113|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
186114|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
186115|NCT01615731|E2|Reported Event|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
186116|NCT01615731|E1|Reported Event|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
186117|NCT01615484|B3|Baseline|Total|Total of all reporting groups
186121|NCT01615484|P1|Participant Flow|Ex-vivo Lung Perfusion With STEEN Solution™|Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan.
186122|NCT01615484|O2|Outcome|Lung Transplant From Conventional Brain-dead Organ Donor|No experimental procedures will be carried out.
186123|NCT01615484|O1|Outcome|Ex-vivo Lung Perfusion With STEEN Solution™|Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan.
186124|NCT01615484|O2|Outcome|Lung Transplant From Conventional Brain-dead Organ Donor|No experimental procedures will be carried out.
186125|NCT01615484|O1|Outcome|Ex-vivo Lung Perfusion With STEEN Solution™|Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan.
186126|NCT01615484|O2|Outcome|Lung Transplant From Conventional Brain-dead Organ Donor|No experimental procedures will be carried out.
186127|NCT01615484|O1|Outcome|Ex-vivo Lung Perfusion With STEEN Solution™|Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan.
186128|NCT01615484|O2|Outcome|Lung Transplant From Conventional Brain-dead Organ Donor|No experimental procedures will be carried out.
186129|NCT01615484|O1|Outcome|Ex-vivo Lung Perfusion With STEEN Solution™|Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan.
186130|NCT01615484|O2|Outcome|Lung Transplant From Conventional Brain-dead Organ Donor|No experimental procedures will be carried out.
186131|NCT01615484|O1|Outcome|Ex-vivo Lung Perfusion With STEEN Solution™|Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan.
186132|NCT01615484|O2|Outcome|Lung Transplant From Conventional Brain-dead Organ Donor|No experimental procedures will be carried out.
186133|NCT01615484|O1|Outcome|Ex-vivo Lung Perfusion With STEEN Solution™|Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan.
186134|NCT01615484|E2|Reported Event|Lung Transplant From Conventional Brain-dead Organ Donor|No experimental procedures will be carried out.
186135|NCT01615484|E1|Reported Event|Ex-vivo Lung Perfusion With STEEN Solution™|Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan.
186136|NCT01615367|B3|Baseline|Total|Total of all reporting groups
186137|NCT01615367|B2|Baseline|Treatment as Usual (TAU)|"19 people were randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration.~Typically consists of at least one FDA-approved mood stabilizer: Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer."
186138|NCT01615367|B1|Baseline|NEW Tx|"19 people were randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long.~Nutrition, Exercise, and Wellness (NEW) psychotherapy: NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients."
186139|NCT01615367|P2|Participant Flow|Treatment as Usual (TAU)|"19 people were randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration.~Typically consists of at least one FDA-approved mood stabilizer: Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer."
186140|NCT01615367|P1|Participant Flow|NEW Tx|"19 people were randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long.~Nutrition, Exercise, and Wellness (NEW) psychotherapy: NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients."
186141|NCT01615367|O2|Outcome|Treatment as Usual (TAU)|"19 people were randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration.~Typically consists of at least one FDA-approved mood stabilizer: Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer."
186142|NCT01615367|O1|Outcome|NEW Tx|"19 people were randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long.~Nutrition, Exercise, and Wellness (NEW) psychotherapy: NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients."
186143|NCT01615367|O2|Outcome|Treatment as Usual (TAU)|"19 people were randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration.~Typically consists of at least one FDA-approved mood stabilizer: Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer."
186144|NCT01615367|O1|Outcome|NEW Tx|"19 people were randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long.~Nutrition, Exercise, and Wellness (NEW) psychotherapy: NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients."
186436|NCT01613417|O1|Outcome|Reader 1|Lesions reviewed by Reader 1
186145|NCT01615367|O2|Outcome|Treatment as Usual (TAU)|"19 people were randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration.~Typically consists of at least one FDA-approved mood stabilizer: Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer."
186146|NCT01615367|O1|Outcome|NEW Tx|"19 people were randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long.~Nutrition, Exercise, and Wellness (NEW) psychotherapy: NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients."
186147|NCT01615367|O2|Outcome|Treatment as Usual (TAU)|"19 people were randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration.~Typically consists of at least one FDA-approved mood stabilizer: Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer."
186148|NCT01615367|O1|Outcome|NEW Tx|"19 people were randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long.~Nutrition, Exercise, and Wellness (NEW) psychotherapy: NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients."
186149|NCT01615367|O2|Outcome|Treatment as Usual (TAU)|"19 people were randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration.~Typically consists of at least one FDA-approved mood stabilizer: Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer."
186150|NCT01615367|O1|Outcome|NEW Tx|"19 people were randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long.~Nutrition, Exercise, and Wellness (NEW) psychotherapy: NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients."
186151|NCT01615367|O2|Outcome|Treatment as Usual (TAU)|"19 people were randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration.~Typically consists of at least one FDA-approved mood stabilizer: Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer."
186152|NCT01615367|O1|Outcome|NEW Tx|"19 people were randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long.~Nutrition, Exercise, and Wellness (NEW) psychotherapy: NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients."
186153|NCT01615367|O2|Outcome|Treatment as Usual (TAU)|"19 people were randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration.~Typically consists of at least one FDA-approved mood stabilizer: Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer."
186154|NCT01615367|O1|Outcome|NEW Tx|"19 people were randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long.~Nutrition, Exercise, and Wellness (NEW) psychotherapy: NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients."
186155|NCT01615367|E2|Reported Event|Treatment as Usual (TAU)|"19 people were randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration.~Typically consists of at least one FDA-approved mood stabilizer: Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer."
186156|NCT01615367|E1|Reported Event|NEW Tx|"19 people were randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long.~Nutrition, Exercise, and Wellness (NEW) psychotherapy: NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients."
186157|NCT01615328|B3|Baseline|Total|Total of all reporting groups
186158|NCT01615328|B2|Baseline|Bonion|The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
186159|NCT01615328|B1|Baseline|Cervios ChronOS|The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
186160|NCT01615328|P2|Participant Flow|Bonion|The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
186161|NCT01615328|P1|Participant Flow|Cervios ChronOS|The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
186437|NCT01613417|O3|Outcome|Reader 3|Lesions reviewed by Reader 3
186162|NCT01615328|O2|Outcome|Bonion|"The ACDF surgery will be carried out with Bonion(TM), which is the PEEK cage with HA/DBM.~Bonion: The ACDF surgery will be caried out with Bonion after randomization procedure."
186163|NCT01615328|O1|Outcome|Cervios ChronOs|"The ACDF surgery will be carried out with Cervios ChronOs(TM), which is the PEEK cage filled with b-TCP.~Cervios ChronOs: The ACDF surgery will be caried out with Cervios ChronOs after randomization procedure."
186164|NCT01615328|O2|Outcome|Bonion|"The ACDF surgery will be carried out with Bonion(TM), which is the PEEK cage with HA/DBM.~Bonion: The ACDF surgery will be carried out with Bonion after randomization procedure."
186165|NCT01615328|O1|Outcome|Cervios ChronOs|"The ACDF surgery will be carried out with Cervios ChronOs(TM), which is the PEEK cage filled with b-TCP.~Cervios ChronOs: The ACDF surgery will be carried out with Cervios ChronOs after randomization procedure."
186166|NCT01615328|O2|Outcome|Bonion|The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
186167|NCT01615328|O1|Outcome|Cervios ChronOS|The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
186168|NCT01615328|E2|Reported Event|Bonion|The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
186169|NCT01615328|E1|Reported Event|Cervios ChronOS|The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
186170|NCT01615263|B3|Baseline|Total|Total of all reporting groups
186171|NCT01615263|B2|Baseline|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
186172|NCT01615263|B1|Baseline|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Ireland.)
186173|NCT01615263|P2|Participant Flow|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
186174|NCT01615263|P1|Participant Flow|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Ireland.)
186175|NCT01615263|O2|Outcome|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
186176|NCT01615263|O1|Outcome|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.)
186177|NCT01615263|O2|Outcome|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
186178|NCT01615263|O1|Outcome|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.)
186179|NCT01615263|O2|Outcome|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
186180|NCT01615263|O1|Outcome|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.)
186181|NCT01615263|O2|Outcome|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
186182|NCT01615263|O1|Outcome|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.)
186183|NCT01615263|E2|Reported Event|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9F, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
186184|NCT01615263|E1|Reported Event|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.)
186185|NCT01615198|B3|Baseline|Total|Total of all reporting groups
186186|NCT01615198|B2|Baseline|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
186187|NCT01615198|B1|Baseline|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
186188|NCT01615198|P2|Participant Flow|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
186189|NCT01615198|P1|Participant Flow|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
186190|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
186258|NCT01614886|O1|Outcome|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
186260|NCT01614886|O1|Outcome|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
186191|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
186192|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
186193|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
186194|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
186195|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
186196|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
186197|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
186198|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
186199|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
186200|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
186201|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
186202|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
186203|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
186204|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
186205|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
186206|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
186261|NCT01614886|E2|Reported Event|Rivastigmine Patch 3-step|Rivastigmine patch 3-step
186262|NCT01614886|E1|Reported Event|Rivastigmine Patch 1-step|Rivastigmine patch 1-step
186207|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
186208|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
186209|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
186210|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
186211|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
186212|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
186213|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
186214|NCT01615198|E2|Reported Event|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
186215|NCT01615198|E1|Reported Event|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
186216|NCT01615029|B6|Baseline|Total|Total of all reporting groups
186217|NCT01615029|B5|Baseline|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186218|NCT01615029|B4|Baseline|Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186219|NCT01615029|B3|Baseline|Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186220|NCT01615029|B2|Baseline|Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186221|NCT01615029|B1|Baseline|Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186222|NCT01615029|P5|Participant Flow|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186263|NCT01614795|B5|Baseline|Total|Total of all reporting groups
186438|NCT01613417|O2|Outcome|Reader 2|Lesions reviewed by Reader 2
186223|NCT01615029|P4|Participant Flow|Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186224|NCT01615029|P3|Participant Flow|Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186225|NCT01615029|P2|Participant Flow|Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186226|NCT01615029|P1|Participant Flow|Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186227|NCT01615029|O1|Outcome|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186228|NCT01615029|O1|Outcome|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186229|NCT01615029|O4|Outcome|Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186230|NCT01615029|O3|Outcome|Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186231|NCT01615029|O2|Outcome|Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186232|NCT01615029|O1|Outcome|Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186233|NCT01615029|O1|Outcome|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186234|NCT01615029|O1|Outcome|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186235|NCT01615029|O1|Outcome|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186236|NCT01615029|O1|Outcome|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186259|NCT01614886|O2|Outcome|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
186374|NCT01614457|O1|Outcome|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
186237|NCT01615029|O4|Outcome|Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186238|NCT01615029|O3|Outcome|Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186239|NCT01615029|O2|Outcome|Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186240|NCT01615029|O1|Outcome|Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186241|NCT01615029|E5|Reported Event|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186242|NCT01615029|E4|Reported Event|Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186243|NCT01615029|E3|Reported Event|Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186244|NCT01615029|E2|Reported Event|Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186245|NCT01615029|E1|Reported Event|Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
186246|NCT01614886|B3|Baseline|Total|Total of all reporting groups
186247|NCT01614886|B2|Baseline|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
186248|NCT01614886|B1|Baseline|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
186249|NCT01614886|P2|Participant Flow|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
186250|NCT01614886|P1|Participant Flow|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
186251|NCT01614886|O2|Outcome|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
186252|NCT01614886|O1|Outcome|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
186253|NCT01614886|O2|Outcome|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
186254|NCT01614886|O1|Outcome|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
186255|NCT01614886|O2|Outcome|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
186256|NCT01614886|O1|Outcome|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
186257|NCT01614886|O2|Outcome|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
186375|NCT01614457|O2|Outcome|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
186264|NCT01614795|B4|Baseline|Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
186265|NCT01614795|B3|Baseline|Group 3 Relapsed or Refractory Rhabdomyosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
186266|NCT01614795|B2|Baseline|Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
186267|NCT01614795|B1|Baseline|Group 1 Relapsed or Refractory Osteosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
186268|NCT01614795|P4|Participant Flow|Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
186269|NCT01614795|P3|Participant Flow|Group 3 Relapsed or Refractory Rhabdomyosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
186270|NCT01614795|P2|Participant Flow|Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
186271|NCT01614795|P1|Participant Flow|Group 1 Relapsed or Refractory Osteosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
186272|NCT01614795|O4|Outcome|Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
186273|NCT01614795|O3|Outcome|Group 3 Relapsed or Refractory Rhabdomyosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
186274|NCT01614795|O2|Outcome|Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
186275|NCT01614795|O1|Outcome|Group 1 Relapsed or Refractory Osteosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
186439|NCT01613417|O1|Outcome|Reader 1|Lesions reviewed by Reader 1
186276|NCT01614795|E4|Reported Event|Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
186277|NCT01614795|E3|Reported Event|Group 3 Relapsed or Refractory Rhabdomyosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
186278|NCT01614795|E2|Reported Event|Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
186279|NCT01614795|E1|Reported Event|Group 1 Relapsed or Refractory Osteosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
186280|NCT01614769|B1|Baseline|All Participants|All randomized participants
186281|NCT01614769|P6|Participant Flow|Glimepiride 4 mg → Glimepiride 2 mg → Placebo|Participants received 4 mg glimepiride in the first period, 2 mg glimepiride in the second period and placebo in the third period, with a 7-day washout between each period.
186282|NCT01614769|P5|Participant Flow|Glimepiride 2 mg → Placebo → Glimepiride 4 mg|Participants received 2 mg glimepiride in the first period, placebo in the second period and 4 mg glimepiride in the third period, with a 7-day washout between each period.
186283|NCT01614769|P4|Participant Flow|Placebo → Glimepiride 4 mg → Glimepiride 2 mg|Participants received placebo in the first period, 4 mg glimepiride in the second period and 2 mg glimepiride in the third period, with a 7-day washout between each period.
186284|NCT01614769|P3|Participant Flow|Glimepiride 4 mg → Placebo → Glimepiride 2 mg|Participants received 4 mg glimepiride in the first period, placebo in the second period and 2 mg glimepiride in the third period, with a 7-day washout between each period.
186285|NCT01614769|P2|Participant Flow|Glimepiride 2 mg → Glimepiride 4 mg → Placebo|Participants received 2 mg glimepiride in the first period, 4 mg glimepiride in the second period and placebo in the third period, with a 7-day washout between each period.
186286|NCT01614769|P1|Participant Flow|Placebo → Glimepiride 2 mg → Glimepiride 4 mg|Participants received placebo in the first period, 2 mg glimepiride in the second period and 4 mg glimepiride in the third period, with a 7-day washout between each period.
186287|NCT01614769|O3|Outcome|Glimepiride 4 mg|Participants received 4 mg Glimepiride in a treatment period.
186288|NCT01614769|O2|Outcome|Glimepiride 2 mg|Participants received 2 mg Glimepiride in a treatment period.
186289|NCT01614769|O1|Outcome|Placebo|Participants received placebo in a treatment period.
186290|NCT01614769|O3|Outcome|Glimepiride 4 mg|Participants received 4 mg Glimepiride in a treatment period.
186291|NCT01614769|O2|Outcome|Glimepiride 2 mg|Participants received 2 mg Glimepiride in a treatment period.
186292|NCT01614769|O1|Outcome|Placebo|Participants received placebo in a treatment period.
186293|NCT01614769|O3|Outcome|Glimepiride 4 mg|Participants received 4 mg Glimepiride in a treatment period.
186294|NCT01614769|O2|Outcome|Glimepiride 2 mg|Participants received 2 mg Glimepiride in a treatment period.
186295|NCT01614769|O1|Outcome|Placebo|Participants received placebo in a treatment period.
186296|NCT01614769|E3|Reported Event|Glimepiride 4 mg|Participants received 4 mg Glimepiride in a treatment period.
186297|NCT01614769|E2|Reported Event|Glimepiride 2 mg|Participants received 2 mg Glimepiride in a treatment period.
186298|NCT01614769|E1|Reported Event|Placebo|Participants received placebo in a treatment period.
186299|NCT01614613|B1|Baseline|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips
186300|NCT01614613|P1|Participant Flow|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal:safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips.
186331|NCT01614509|O1|Outcome|Monotherapy Group|The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
186301|NCT01614613|O1|Outcome|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems.
186302|NCT01614613|O1|Outcome|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems.
186303|NCT01614613|O1|Outcome|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems.
186304|NCT01614613|O1|Outcome|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips
186305|NCT01614613|O1|Outcome|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips
186306|NCT01614613|E1|Reported Event|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. Subgroup 1 goal:safely decrease subject glucose levels during the visit. Subgroup 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems.
186307|NCT01614600|B1|Baseline|DAILIES® AquaComfort Plus®|Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
186308|NCT01614600|P1|Participant Flow|DAILIES® AquaComfort Plus®|Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
186309|NCT01614600|O1|Outcome|DAILIES® AquaComfort Plus®|Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
186310|NCT01614600|E1|Reported Event|DAILIES® AquaComfort Plus®|Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
186311|NCT01614574|B1|Baseline|VPRIV® (15-60 U/kg)|
186312|NCT01614574|P1|Participant Flow|VPRIV® (15-60 U/kg)|
186313|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
186314|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
186315|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
186316|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
186317|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
186318|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
186319|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
186320|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
186321|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
186322|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
186323|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
186324|NCT01614574|E1|Reported Event|VPRIV® (15-60 U/kg)|
186325|NCT01614509|B3|Baseline|Total|Total of all reporting groups
186326|NCT01614509|B2|Baseline|Combined Group|The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
186327|NCT01614509|B1|Baseline|Monotherapy Group|The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
186328|NCT01614509|P2|Participant Flow|Combined Group|The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
186329|NCT01614509|P1|Participant Flow|Monotherapy Group|The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
186330|NCT01614509|O2|Outcome|Combined Group|The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
186368|NCT01614457|O1|Outcome|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
186332|NCT01614509|O2|Outcome|Combined Group|The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
186333|NCT01614509|O1|Outcome|Monotherapy Group|The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
186334|NCT01614509|E2|Reported Event|Combined Group|The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
186335|NCT01614509|E1|Reported Event|Monotherapy Group|The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
186336|NCT01614470|B3|Baseline|Total|Total of all reporting groups
186337|NCT01614470|B2|Baseline|Part 1: Placebo First, Then Ivacaftor|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 1 followed by ivacaftor 150 mg tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period.
186338|NCT01614470|B1|Baseline|Part 1: Ivacaftor First, Then Placebo|Ivacaftor 150 milligram (mg) tablet orally twice daily for 8 weeks in treatment period 1 followed by placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period.
186339|NCT01614470|P3|Participant Flow|Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 16 weeks.
186340|NCT01614470|P2|Participant Flow|Part 1: Placebo First, Then Ivacaftor|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 1 followed by ivacaftor 150 mg tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period.
186341|NCT01614470|P1|Participant Flow|Part 1: Ivacaftor First, Then Placebo|Ivacaftor 150 milligram (mg) tablet orally twice daily for 8 weeks in treatment period 1 followed by placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period.
186342|NCT01614470|O1|Outcome|Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 16 weeks.
186343|NCT01614470|O2|Outcome|Part 1: Placebo|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
186344|NCT01614470|O1|Outcome|Part 1: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
186345|NCT01614470|O1|Outcome|Part 1 Treatment Period 2: Ivacaftor, Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 24 weeks (8 weeks in Part 1: Treatment Period 2 and 16 weeks in Part 2).
186346|NCT01614470|O2|Outcome|Part 1: Placebo|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
186347|NCT01614470|O1|Outcome|Part 1: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
186348|NCT01614470|O1|Outcome|Part 1 Treatment Period 2: Ivacaftor, Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 24 weeks (8 weeks in Part 1: Treatment Period 2 and 16 weeks in Part 2).
186349|NCT01614470|O1|Outcome|Part 1 Treatment Period 2: Ivacaftor, Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 24 weeks (8 weeks in Part 1: Treatment Period 2 and 16 weeks in Part 2).
186350|NCT01614470|O2|Outcome|Part 1: Placebo|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
186351|NCT01614470|O1|Outcome|Part 1: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
186352|NCT01614470|O1|Outcome|Part 1 Treatment Period 2: Ivacaftor, Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 24 weeks (8 weeks in Part 1: Treatment Period 2 and 16 weeks in Part 2).
186353|NCT01614470|O2|Outcome|Part 1: Placebo|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
186354|NCT01614470|O1|Outcome|Part 1: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
186355|NCT01614470|O2|Outcome|Part 1: Placebo|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
186356|NCT01614470|O1|Outcome|Part 1: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
186357|NCT01614470|E3|Reported Event|Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 16 weeks.
186358|NCT01614470|E2|Reported Event|Part 1: Placebo|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
186359|NCT01614470|E1|Reported Event|Part 1: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
186360|NCT01614457|B3|Baseline|Total|Total of all reporting groups
186361|NCT01614457|B2|Baseline|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
186362|NCT01614457|B1|Baseline|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
186363|NCT01614457|P2|Participant Flow|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
186364|NCT01614457|P1|Participant Flow|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
186365|NCT01614457|O2|Outcome|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
186366|NCT01614457|O1|Outcome|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
186367|NCT01614457|O2|Outcome|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
186376|NCT01614457|O1|Outcome|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
186377|NCT01614457|E2|Reported Event|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
186378|NCT01614457|E1|Reported Event|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
186379|NCT01614249|B3|Baseline|Total|Total of all reporting groups
186380|NCT01614249|B2|Baseline|Fish Oil Omega-3 EPA-rich Soft Gels Experimental Group|"As the intervention group, participants received a dietary supplement of Omega Via fish oil omega-3 EPA-rich soft gels to take orally for eight weeks with bi-weekly follow-up visits to resupply the soft-gels, monitoring of side effects and compliance and data collection.~Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing fish oil omega-3 EPA-rich soft gels to take for two weeks before returning for re-supply. Each participants took three soft gels of fish oil omega-3 fatty acid per day, each containing more EPA (0.715 grams) than docosahexaenoic acid (DHA) of 0.340 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
186381|NCT01614249|B1|Baseline|Soybean Oil Soft Gels Control Group|"As a control group, participants received OmegaVia soybean oil soft gels for eight weeks with regular cell-phone and bi-weekly face-to-face follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.~Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing soybean oil soft gels to take for two weeks before returning for re-supply. Three soft gels of soybean oil were taken by each participant per day. Each soft gel contained saturated fatty acids (0.178 grams), monounsaturated fatty acids (0.299 grams) and polyunsaturated fatty acids (0.985 grams) with traces of eicosapentaenoic acid (EPA), of 0.115 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
186382|NCT01614249|P2|Participant Flow|Fish Oil Omega-3 EPA-rich Experimental Group|"As the experimental group, participants received dietary supplement of OmegaVia fish oil omega-3 EPA-rich soft gels to take orally for eight weeks with bi-weekly follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.~Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing fish oil omega-3 EPA-rich soft gels to take for two weeks before returning for re-supply. Three soft gels of fish oil omega-3 fatty acid were taken by each participant per day. Each soft gel contained more eicosapentaenoic acid (EPA) of 0.715 grams than docosahexaenoic acid (DHA) of 0.340 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
186383|NCT01614249|P1|Participant Flow|Soybean Oil Soft Gels Control Group|"As a control group, participants received OmegaVia soybean oil soft gels for eight weeks with regular cell-phone and bi-weekly face-to-face follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.~Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing soybean oil soft gels to take for two weeks before returning for re-supply. Three soft gels of soybean oil were taken by each participant per day. Each soft gel contained saturated fatty acids (0.178 grams), monounsaturated fatty acids (0.299 grams) and polyunsaturated fatty acids (0.985 grams) with traces of eicosapentaenoic acid (EPA), of 0.115 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
186384|NCT01614249|O2|Outcome|Fish Oil Omega-3 EPA-rich Soft Gels Experimental Group|"As the experimental group, participants received dietary supplement of OmegaVia fish oil omega-3 EPA-rich soft gels to take orally for eight weeks with bi-weekly follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.~Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing fish oil omega-3 EPA-rich soft gels to take for two weeks before returning for re-supply. Three soft gels of fish oil omega-3 fatty acid were taken by each participant per day. Each soft gel contained more eicosapentaenoic acid (EPA) of 0.715 grams than docosahexaenoic acid (DHA) of 0.340 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
186385|NCT01614249|O1|Outcome|Soybean Oil Soft Gels Control Group|"As a control group, participants received OmegaVia soybean oil soft gels for eight weeks with regular cell-phone and bi-weekly face-to-face follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.~Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing soybean oil soft gels to take for two weeks before returning for re-supply. Three soft gels of soybean oil were taken by each participant per day. Each soft gel contained saturated fatty acids (0.178 grams), monounsaturated fatty acids (0.299 grams) and polyunsaturated fatty acids (0.985 grams) with traces of eicosapentaenoic acid (EPA), of 0.115 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
186386|NCT01614249|E2|Reported Event|Fish Oil Omega-3 EPA-rich Soft Gels|"Participants received OmegaVia fish oil omega-3 EPA-rich soft gels to take orally for eight (8) weeks with bi-weekly follow-up visits for monitoring of side effects and compliance and data collection.~Fish oil omega-3 EPA-rich soft gels: A total of 3.0g of OmegaVia fish oil omega-3 EPA-rich soft gels was taken orally per day as one soft gel in the morning, mid-day and evening after meals for 8 weeks with bi-weekly follow-up visits."
186387|NCT01614249|E1|Reported Event|Soybean Oil Soft Gels|"Participants on this arm received a dietary supplement of OmegaVia soybean oil soft gels as a placebo for 8 weeks with bi-weekly follow-up visits to monitor side effects and compliance.~Soybean oil soft gels: Each participant received OmegaVia soybean oil soft gels to take orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
186388|NCT01614210|B1|Baseline|Tamoxifen Pre and Post Breast Surgery|"All patients enrolled in the study.~Tamoxifen: All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery.~Breast cancer surgery: Breast cancer surgery"
186389|NCT01614210|P1|Participant Flow|Tamoxifen Pre and Post Breast Surgery|"All patients enrolled in the study.~Tamoxifen: All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery.~Breast cancer surgery: Breast cancer surgery"
186428|NCT01613417|O6|Outcome|Reader 3 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
186390|NCT01614210|O1|Outcome|Tamoxifen Pre and Post Breast Surgery|"All patients enrolled in the study.~Tamoxifen: All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery.~Breast cancer surgery: Breast cancer surgery"
186391|NCT01614210|O1|Outcome|Tamoxifen Pre and Post Breast Surgery|"All patients enrolled in the study.~Tamoxifen: All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery.~Breast cancer surgery: Breast cancer surgery"
186392|NCT01614210|O1|Outcome|Tamoxifen Pre and Post Breast Surgery|"All patients enrolled in the study.~Tamoxifen: All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery.~Breast cancer surgery: Breast cancer surgery"
186393|NCT01614210|E1|Reported Event|Tamoxifen Pre and Post Breast Surgery|"All patients enrolled in the study.~Tamoxifen: All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery.~Breast cancer surgery: Breast cancer surgery"
186394|NCT01614093|B1|Baseline|Oxytocin vs Placebo|Participants rated themselves as significantly less hungry when administered OT (M=36.37, SD=21.0) than placebo (M=44.81, SD=28.6) at 60 min. post-preload, F(5, 15)=8.05, p=0.012.
186395|NCT01614093|P1|Participant Flow|Oxytocin/ Placebo|Each participant will receive intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects.
186396|NCT01614093|O1|Outcome|Oxytocin/Placebo|Each participant received intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects.
186397|NCT01614093|E2|Reported Event|Placebo|Each participant will receive intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects.
186398|NCT01614093|E1|Reported Event|Oxytocin|Each participant will receive intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects.
186399|NCT01613716|B1|Baseline|Ozurdex|"Subjects will receive Ozurdex injections and will be monitored for macular edema.~Ozurdex: Ozurdex .7 mg injected into the treated eye"
186400|NCT01613716|P1|Participant Flow|Ozurdex|"Subjects will receive Ozurdex injections and will be monitored for macular edema.~Ozurdex: Ozurdex .7 mg injected into the treated eye"
186401|NCT01613716|O1|Outcome|Ozurdex|"Subjects will receive Ozurdex injections and will be monitored for macular edema.~Ozurdex: Ozurdex .7 mg injected into the treated eye"
186402|NCT01613716|O1|Outcome|Ozurdex|"Subjects will receive Ozurdex injections and will be monitored for macular edema.~Ozurdex: Ozurdex .7 mg injected into the treated eye"
186403|NCT01613716|E1|Reported Event|Ozurdex|"Subjects will receive Ozurdex injections and will be monitored for macular edema.~Ozurdex: Ozurdex .7 mg injected into the treated eye"
186404|NCT01613599|B1|Baseline|Rituximab|Participants with GPA (Wegener’s granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
186405|NCT01613599|P1|Participant Flow|Rituximab|Participants with granulomatosis with polyangiitis (GPA) (Wegener’s granulomatosis) or microscopic polyangiitis (MPA) who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
186406|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
186407|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
186408|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
186409|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
186410|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
186411|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
186412|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
186413|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
186414|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
186415|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener’s granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
186416|NCT01613599|E1|Reported Event|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years
186417|NCT01613417|B3|Baseline|Total|Total of all reporting groups
186418|NCT01613417|B2|Baseline|Gadovist/Gadavist Then ProHance|Per Protocol=patients who completed both exams, had global paired image data available, and had no major protocol violations
186419|NCT01613417|B1|Baseline|ProHance Then Gadovist/Gadavist|Per Protocol=patients who completed both exams, had global paired image data available, and had no major protocol violations
186420|NCT01613417|P2|Participant Flow|Sequence 2 (Gadovist/Gadavist Then ProHance)|Patients randomized to receive Gadovist/Gadavist first
186421|NCT01613417|P1|Participant Flow|Sequence 1 (ProHance Then Gadovist/Gadavist)|Patients randomized to receive ProHance first
186422|NCT01613417|O6|Outcome|Reader 3 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
186423|NCT01613417|O5|Outcome|Reader 3 - ProHance|MRI after ProHance 0.1 mmol/kg
186424|NCT01613417|O4|Outcome|Reader 2 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
186425|NCT01613417|O3|Outcome|Reader 2 - ProHance|MRI after ProHance 0.1 mmol/kg
186426|NCT01613417|O2|Outcome|Reader 1 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
186427|NCT01613417|O1|Outcome|Reader 1 - ProHance|MRI after ProHance 0.1 mmol/kg
186455|NCT01613417|E2|Reported Event|Safety Population (Gadovist/Gadavist)|All enrolled patients who received a randomized injection of Gadovist/Gadavist
186456|NCT01613417|E1|Reported Event|Safety Population (ProHance)|All enrolled patients who received a randomized injection of ProHance
186457|NCT01613378|B1|Baseline|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
186458|NCT01613378|P1|Participant Flow|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
186459|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
186460|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
186461|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
186462|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
186463|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
186464|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
186465|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
186466|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
186467|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
186468|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
186469|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
186470|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
186471|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
186472|NCT01613378|E1|Reported Event|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
186473|NCT01613339|B3|Baseline|Total|Total of all reporting groups
186474|NCT01613339|B2|Baseline|Control|No specific treatment.
186475|NCT01613339|B1|Baseline|Body Awareness Therapy|Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
186476|NCT01613339|P2|Participant Flow|Control|No specific treatment.
186477|NCT01613339|P1|Participant Flow|Body Awareness Therapy|Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
186478|NCT01613339|O2|Outcome|Control|No specific treatment.
186479|NCT01613339|O1|Outcome|Body Awareness Therapy|Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
186480|NCT01613339|O2|Outcome|Control|No specific treatment.
186481|NCT01613339|O1|Outcome|Body Awareness Therapy|Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
186482|NCT01613339|O2|Outcome|Control|No specific treatment.
186483|NCT01613339|O1|Outcome|Body Awareness Therapy|Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
186484|NCT01613339|E1|Reported Event|Body Awareness Therapy, Control|group training. Controls were asked to continue with their lifestyle.
186485|NCT01613326|B3|Baseline|Total|Total of all reporting groups
194308|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
186486|NCT01613326|B2|Baseline|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186487|NCT01613326|B1|Baseline|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186488|NCT01613326|P2|Participant Flow|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186489|NCT01613326|P1|Participant Flow|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186490|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186491|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186492|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186493|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186494|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186495|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186496|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186497|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186498|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186499|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186500|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186501|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186502|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186503|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186504|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186505|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186506|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186507|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186508|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186509|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186510|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186511|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186512|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186513|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186514|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186515|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186516|NCT01613326|E2|Reported Event|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186517|NCT01613326|E1|Reported Event|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
186518|NCT01613313|B5|Baseline|Total|Total of all reporting groups
186519|NCT01613313|B4|Baseline|Dose #4|"single injection 0.44 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
186520|NCT01613313|B3|Baseline|Dose #3|"single injection 0.29 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
186521|NCT01613313|B2|Baseline|Dose #2|"single injection 0.15 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
186522|NCT01613313|B1|Baseline|Dose #1|"single injection 0.058 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
186970|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
186523|NCT01613313|P4|Participant Flow|Dose #4|"single injection 0.44 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
186524|NCT01613313|P3|Participant Flow|Dose #3|"single injection 0.29 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
186525|NCT01613313|P2|Participant Flow|Dose #2|"single injection 0.15 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
186526|NCT01613313|P1|Participant Flow|Dose #1|"single injection 0.058 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
186527|NCT01613313|O4|Outcome|Dose #4|"single injection 0.44 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
186528|NCT01613313|O3|Outcome|Dose #3|"single injection 0.29 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
186529|NCT01613313|O2|Outcome|Dose #2|"single injection 0.15 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
186530|NCT01613313|O1|Outcome|Dose #1|"single injection 0.058 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
186531|NCT01613313|O4|Outcome|Dose #4|"single injection 0.44 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
186532|NCT01613313|O3|Outcome|Dose #3|"single injection 0.29 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
186533|NCT01613313|O2|Outcome|Dose #2|"single injection 0.15 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
186534|NCT01613313|O1|Outcome|Dose #1|"single injection 0.058 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
186535|NCT01613313|E4|Reported Event|Dose #4|"single injection 0.44 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
186536|NCT01613313|E3|Reported Event|Dose #3|"single injection 0.29 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
186537|NCT01613313|E2|Reported Event|Dose #2|"single injection 0.15 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
186538|NCT01613313|E1|Reported Event|Dose #1|"single injection 0.058 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
186539|NCT01613248|B7|Baseline|Total|Total of all reporting groups
186540|NCT01613248|B6|Baseline|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186541|NCT01613248|B5|Baseline|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186542|NCT01613248|B4|Baseline|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186543|NCT01613248|B3|Baseline|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186544|NCT01613248|B2|Baseline|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186545|NCT01613248|B1|Baseline|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186546|NCT01613248|P6|Participant Flow|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186547|NCT01613248|P5|Participant Flow|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186548|NCT01613248|P4|Participant Flow|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186549|NCT01613248|P3|Participant Flow|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186550|NCT01613248|P2|Participant Flow|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186551|NCT01613248|P1|Participant Flow|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186756|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent|PRO-Kinetic Energy Stent: Coronary artery stent implant
186552|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186553|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186554|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186555|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186556|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186557|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186558|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186559|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186560|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186561|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186562|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186563|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186564|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186565|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186566|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186567|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186568|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186569|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186570|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186571|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186572|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186573|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186574|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186575|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186576|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186577|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186578|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186579|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186580|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186581|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186582|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186583|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186584|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186585|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
194309|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
186586|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186587|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186588|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186589|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186590|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186591|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186592|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186593|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186594|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186595|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186596|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186597|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186598|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186599|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186600|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186601|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186602|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186603|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186604|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186605|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186606|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186607|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186608|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186609|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186610|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186611|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186612|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186613|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186614|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186615|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186616|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186617|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186618|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186619|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186620|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186621|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186622|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186623|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186624|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186625|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186626|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186627|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186628|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186629|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186630|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186631|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186632|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186633|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186634|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186635|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186636|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186637|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186638|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186639|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186640|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186641|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186642|NCT01613248|E6|Reported Event|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186643|NCT01613248|E5|Reported Event|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186644|NCT01613248|E4|Reported Event|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186645|NCT01613248|E3|Reported Event|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186646|NCT01613248|E2|Reported Event|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186647|NCT01613248|E1|Reported Event|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
186648|NCT01613131|B3|Baseline|Total|Total of all reporting groups
186649|NCT01613131|B2|Baseline|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
186650|NCT01613131|B1|Baseline|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
186651|NCT01613131|P2|Participant Flow|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
186757|NCT01612767|E1|Reported Event|Pro-Kinetic Energy Stent|PRO-Kinetic Energy Stent: Coronary artery stent implant
186758|NCT01612702|B3|Baseline|Total|Total of all reporting groups
186652|NCT01613131|P1|Participant Flow|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
186653|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
186654|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
186655|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
186656|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
186657|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
186658|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
186659|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
186660|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
186661|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
186662|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
186663|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
186664|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
186665|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
186666|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
186667|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
186668|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
186669|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
186670|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
186671|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
186672|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
186673|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
186674|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
186759|NCT01612702|B2|Baseline|Control|No dexamethasone
186675|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
186676|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
186677|NCT01613131|E2|Reported Event|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
186678|NCT01613131|E1|Reported Event|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
186679|NCT01613027|B1|Baseline|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
186680|NCT01613027|P1|Participant Flow|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
186681|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
186682|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
186683|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
186684|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
186685|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
186686|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
186687|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
186688|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
186689|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
186690|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
186691|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
186692|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
186693|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
186694|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
186695|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
186696|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
186697|NCT01613027|E1|Reported Event|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
186698|NCT01613014|B3|Baseline|Total|Total of all reporting groups
186699|NCT01613014|B2|Baseline|ABT-436|"ABT-436 Target dose of 400 mg BID~ABT-436: Target dose - 400mg BID"
186700|NCT01613014|B1|Baseline|Sugar Pill|"Matched Placebo sugar pill - target dose 2 pills BID~Matched Placebo - Sugar Pill: Target Dose - 2 pills BID"
186701|NCT01613014|P2|Participant Flow|ABT-436|"ABT-436 Target dose of 400 mg BID~ABT-436: Target dose - 400mg BID"
186702|NCT01613014|P1|Participant Flow|Sugar Pill|"Matched Placebo sugar pill - target dose 2 pills BID~Matched Placebo - Sugar Pill: Target Dose - 2 pills BID"
186703|NCT01613014|O2|Outcome|ABT-436|"ABT-436 Target dose of 400 mg BID~ABT-436: Target dose - 400mg BID"
186704|NCT01613014|O1|Outcome|Sugar Pill|"Matched Placebo sugar pill - target dose 2 pills BID~Matched Placebo - Sugar Pill: Target Dose - 2 pills BID"
186705|NCT01613014|E2|Reported Event|ABT-436|"ABT-436 Target dose of 400 mg BID~ABT-436: Target dose - 400mg BID"
186706|NCT01613014|E1|Reported Event|Sugar Pill|"Matched Placebo sugar pill - target dose 2 pills BID~Matched Placebo - Sugar Pill: Target Dose - 2 pills BID"
186707|NCT01612884|B3|Baseline|Total|Total of all reporting groups
186708|NCT01612884|B2|Baseline|Light Transmittance Aggregometry Guided|"Clopidogrel non-response defined as MPA ADP >42.9% Clopidogrel response defined as MPA ADP <42.9%~Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder~Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder"
186709|NCT01612884|B1|Baseline|Thrombelastography (TEG) Guided|"Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA<69~Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder~Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder"
186710|NCT01612884|P2|Participant Flow|Light Transmittance Aggregometry Guided|"Clopidogrel non-response defined as MPA ADP >42.9% Clopidogrel response defined as MPA ADP <42.9%~Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder~Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder"
186711|NCT01612884|P1|Participant Flow|Thrombelastography (TEG) Guided|"Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA<69~Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder~Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder"
186712|NCT01612884|O2|Outcome|Light Transmittance Aggregometry Guided|"Clopidogrel non-response defined as MPA ADP >42.9% Clopidogrel response defined as MPA ADP <42.9%~Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder~Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder"
186713|NCT01612884|O1|Outcome|Thrombelastography (TEG) Guided|"Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA<69~Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder~Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder"
186760|NCT01612702|B1|Baseline|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
186714|NCT01612884|O2|Outcome|Light Transmittance Aggregometry Guided|"Clopidogrel non-response defined as MPA ADP >42.9% Clopidogrel response defined as MPA ADP <42.9%~Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder~Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder"
186715|NCT01612884|O1|Outcome|Thrombelastography (TEG) Guided|"Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA<69~Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder~Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder"
186716|NCT01612884|O2|Outcome|Light Transmittance Aggregometry Guided|"Clopidogrel non-response defined as MPA ADP >42.9% Clopidogrel response defined as MPA ADP <42.9%~Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder~Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder"
186717|NCT01612884|O1|Outcome|Thrombelastography (TEG) Guided|"Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA<69~Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder~Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder"
186718|NCT01612884|E2|Reported Event|Light Transmittance Aggregometry Guided|"Clopidogrel non-response defined as MPA ADP >42.9% Clopidogrel response defined as MPA ADP <42.9%~Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder~Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder"
186719|NCT01612884|E1|Reported Event|Thrombelastography (TEG) Guided|"Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA<69~Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder~Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder"
186720|NCT01612858|B3|Baseline|Total|Total of all reporting groups
186721|NCT01612858|B2|Baseline|Pioglitazone|Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
186722|NCT01612858|B1|Baseline|Metformin|Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
186723|NCT01612858|P2|Participant Flow|Pioglitazone|Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
186724|NCT01612858|P1|Participant Flow|Metformin|Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
186725|NCT01612858|O2|Outcome|Pioglitazone|Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
186726|NCT01612858|O1|Outcome|Metformin|Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
186727|NCT01612858|O2|Outcome|Pioglitazone|Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
186728|NCT01612858|O1|Outcome|Metformin|Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
186729|NCT01612858|E2|Reported Event|Pioglitazone|Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
186730|NCT01612858|E1|Reported Event|Metformin|Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
186731|NCT01612767|B1|Baseline|Pro-Kinetic Energy Stent|PRO-Kinetic Energy Stent: Coronary artery stent implant
186732|NCT01612767|P1|Participant Flow|Pro-Kinetic Energy Stent|PRO-Kinetic Energy Stent: Coronary artery stent implant
186733|NCT01612767|O4|Outcome|PRO-Kinetic Energy Stent - 9 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
186734|NCT01612767|O3|Outcome|PRO-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
186735|NCT01612767|O2|Outcome|PRO-Kinetic Energy Stent - Discharge|PRO-Kinetic Energy Stent: Coronary artery stent implant
186736|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent - Baseline|PRO-Kinetic Energy Stent: Coronary artery stent implant
186737|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent|PRO-Kinetic Energy Stent: Coronary artery stent implant
186738|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent|PRO-Kinetic Energy Stent: Coronary artery stent implant
186739|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent|PRO-Kinetic Energy Stent: Coronary artery stent implant
186740|NCT01612767|O2|Outcome|PRO-Kinetic Energy Stent - 9 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
186741|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
186742|NCT01612767|O2|Outcome|PRO-Kinetic Energy Stent - 9 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
186743|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
186744|NCT01612767|O2|Outcome|PRO-Kinetic Energy Stent - 9 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
186745|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
186746|NCT01612767|O2|Outcome|PRO-Kinetic Energy Stent - 9 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
186747|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
186748|NCT01612767|O2|Outcome|PRO-Kinetic Energy Stent - 9 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
186749|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
186750|NCT01612767|O2|Outcome|PRO-Kinetic Energy Stent - 9 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
186751|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
186752|NCT01612767|O2|Outcome|PRO-Kinetic Energy Stent - 9 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
186753|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
186754|NCT01612767|O1|Outcome|PRO-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
186755|NCT01612767|O1|Outcome|PRO-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
186762|NCT01612702|P1|Participant Flow|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
186763|NCT01612702|O2|Outcome|Control|No dexamethasone
186764|NCT01612702|O1|Outcome|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
186765|NCT01612702|O2|Outcome|Control|No dexamethasone
186766|NCT01612702|O1|Outcome|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
186767|NCT01612702|O2|Outcome|Control|No dexamethasone
186768|NCT01612702|O1|Outcome|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
186769|NCT01612702|E2|Reported Event|Control|No dexamethasone
186770|NCT01612702|E1|Reported Event|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
186771|NCT01612676|B5|Baseline|Total|Total of all reporting groups
186772|NCT01612676|B4|Baseline|Infusion Regimen 4|FE 202158 0.1 mg/ml (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186773|NCT01612676|B3|Baseline|Infusion Regimen 3|FE 202158 0.1 mg/ml (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186774|NCT01612676|B2|Baseline|Infusion Regimen 2|FE 202158 0.1 mg/ml (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186775|NCT01612676|B1|Baseline|Infusion Regimen 1|FE 202158 0.1 mg/ml (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186776|NCT01612676|P4|Participant Flow|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186777|NCT01612676|P3|Participant Flow|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186778|NCT01612676|P2|Participant Flow|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186779|NCT01612676|P1|Participant Flow|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186780|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186781|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186782|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186783|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186784|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186785|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186786|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186787|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186788|NCT01612676|O1|Outcome|Full Analysis Set|The full analysis data set (FAS) comprised data from all dosed patients.
186789|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186790|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186791|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186792|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186793|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186794|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186795|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186796|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186797|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186798|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186799|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186800|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186801|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186802|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186803|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186804|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186805|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186806|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186807|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186808|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186809|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186971|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
194310|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
186810|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186811|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186812|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186813|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186814|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186815|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186816|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186817|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186818|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186819|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186820|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186821|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186822|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186823|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186824|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186825|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186826|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186827|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186828|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186829|NCT01612676|E5|Reported Event|Total|Summation of adverse events in all treatment arms
186830|NCT01612676|E4|Reported Event|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186831|NCT01612676|E3|Reported Event|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186832|NCT01612676|E2|Reported Event|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186833|NCT01612676|E1|Reported Event|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
186834|NCT01612546|B1|Baseline|Treatment (Cyclodextrin-based Polymer-camptothecin CRLX101)|"Patients receive cyclodextrin-based polymer-camptothecin CRLX101 IV over 60 minutes on days 1 and 15 at 15 mg/m^2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the completion of 6 courses, patients achieving stable disease or better may receive treatment for an additional 6 months.~cyclodextrin-based polymer-camptothecin CRLX101: Given IV~Laboratory biomarker analysis: Correlative studies~Pharmacological studies: Correlative studies"
186835|NCT01612546|P1|Participant Flow|Treatment (Cyclodextrin-based Polymer-camptothecin CRLX101)|"Patients receive cyclodextrin-based polymer-camptothecin CRLX101 IV over 60 minutes on days 1 and 15 at 15 mg/m^2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the completion of 6 courses, patients achieving stable disease or better may receive treatment for an additional 6 months.~cyclodextrin-based polymer-camptothecin CRLX101: Given IV~Laboratory biomarker analysis: Correlative studies~Pharmacological studies: Correlative studies"
186836|NCT01612546|O1|Outcome|Treatment (Cyclodextrin-based Polymer-camptothecin CRLX101)|"Patients receive cyclodextrin-based polymer-camptothecin CRLX101 IV over 60 minutes on days 1 and 15 at 15 mg/m^2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the completion of 6 courses, patients achieving stable disease or better may receive treatment for an additional 6 months.~cyclodextrin-based polymer-camptothecin CRLX101: Given IV~Laboratory biomarker analysis: Correlative studies~Pharmacological studies: Correlative studies"
186837|NCT01612546|O1|Outcome|Treatment (Cyclodextrin-based Polymer-camptothecin CRLX101)|"Patients receive cyclodextrin-based polymer-camptothecin CRLX101 IV over 60 minutes on days 1 and 15 at 15 mg/m^2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the completion of 6 courses, patients achieving stable disease or better may receive treatment for an additional 6 months.~cyclodextrin-based polymer-camptothecin CRLX101: Given IV~Laboratory biomarker analysis: Correlative studies~Pharmacological studies: Correlative studies"
186838|NCT01612546|O1|Outcome|Treatment (Cyclodextrin-based Polymer-camptothecin CRLX101)|"Patients receive cyclodextrin-based polymer-camptothecin CRLX101 IV over 60 minutes on days 1 and 15 at 15 mg/m^2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the completion of 6 courses, patients achieving stable disease or better may receive treatment for an additional 6 months.~cyclodextrin-based polymer-camptothecin CRLX101: Given IV~Laboratory biomarker analysis: Correlative studies~Pharmacological studies: Correlative studies"
186839|NCT01612546|O1|Outcome|Treatment (Cyclodextrin-based Polymer-camptothecin CRLX101)|"Patients receive cyclodextrin-based polymer-camptothecin CRLX101 IV over 60 minutes on days 1 and 15 at 15 mg/m^2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the completion of 6 courses, patients achieving stable disease or better may receive treatment for an additional 6 months.~cyclodextrin-based polymer-camptothecin CRLX101: Given IV~Laboratory biomarker analysis: Correlative studies~Pharmacological studies: Correlative studies"
186840|NCT01612546|O1|Outcome|Treatment (Cyclodextrin-based Polymer-camptothecin CRLX101)|"Patients receive cyclodextrin-based polymer-camptothecin CRLX101 IV over 60 minutes on days 1 and 15 at 15 mg/m^2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the completion of 6 courses, patients achieving stable disease or better may receive treatment for an additional 6 months.~cyclodextrin-based polymer-camptothecin CRLX101: Given IV~Laboratory biomarker analysis: Correlative studies~Pharmacological studies: Correlative studies"
186841|NCT01612546|E1|Reported Event|Treatment (Cyclodextrin-based Polymer-camptothecin CRLX101)|"Patients receive cyclodextrin-based polymer-camptothecin CRLX101 IV over 60 minutes on days 1 and 15 at 15 mg/m^2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the completion of 6 courses, patients achieving stable disease or better may receive treatment for an additional 6 months.~cyclodextrin-based polymer-camptothecin CRLX101: Given IV~Laboratory biomarker analysis: Correlative studies~Pharmacological studies: Correlative studies"
186842|NCT01612494|B3|Baseline|Total|Total of all reporting groups
186843|NCT01612494|B2|Baseline|Hypertonic Saline|
186844|NCT01612494|B1|Baseline|Normal Saline|
186845|NCT01612494|P2|Participant Flow|Hypertonic Saline|
186846|NCT01612494|P1|Participant Flow|Normal Saline|
186847|NCT01612494|O2|Outcome|Hypertonic Saline|
186848|NCT01612494|O1|Outcome|Normal Saline|
186849|NCT01612494|E2|Reported Event|Hypertonic Saline|
186850|NCT01612494|E1|Reported Event|Normal Saline|
186851|NCT01612351|B1|Baseline|Induction Chemotherapy Followed by Transoral Surgery|All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
186852|NCT01612351|P1|Participant Flow|Induction Chemotherapy Followed by Transoral Surgery|All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
194311|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
186853|NCT01612351|O1|Outcome|Induction Chemotherapy Followed by Transoral Surgery|All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
186854|NCT01612351|O3|Outcome|1 Year Post Surgery|All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
186855|NCT01612351|O2|Outcome|Post-Induction|All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
186856|NCT01612351|O1|Outcome|Pre-treatment|All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
186857|NCT01612351|O3|Outcome|1 Year Post Surgery|All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
186858|NCT01612351|O2|Outcome|Post-Induction|All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
186859|NCT01612351|O1|Outcome|Pre-treatment|All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
186860|NCT01612351|O1|Outcome|Induction Chemotherapy Followed by Transoral Surgery|All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
186861|NCT01612351|O1|Outcome|Induction Chemotherapy Followed by Transoral Surgery|All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
186862|NCT01612351|E1|Reported Event|Induction Chemotherapy Followed by Transoral Surgery|All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
186863|NCT01612221|B3|Baseline|Total|Total of all reporting groups
186864|NCT01612221|B2|Baseline|Placebo Group|"Participants not receiving NAC (N-acetylcysteine)~Placebo arm: Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose.~Then repeated 24 hours later."
186865|NCT01612221|B1|Baseline|Patients Receiving N-acetylcysteine|"Patients receiving NAC (N-acetylcysteine)~N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses"
186866|NCT01612221|P2|Participant Flow|Placebo Group|"Participants not receiving NAC (N-acetylcysteine)~Placebo arm: Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose.~Then repeated 24 hours later."
186867|NCT01612221|P1|Participant Flow|Patients Receiving N-acetylcysteine|"Patients receiving NAC (N-acetylcysteine)~N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses"
186868|NCT01612221|O2|Outcome|Placebo Group|"Participants not receiving NAC (N-acetylcysteine)~Placebo arm: Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose.~Then repeated 24 hours later."
186869|NCT01612221|O1|Outcome|Patients Receiving N-acetylcysteine|"Patients receiving NAC (N-acetylcysteine)~N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses"
186870|NCT01612221|O2|Outcome|Placebo Group|"Participants not receiving NAC (N-acetylcysteine)~Placebo arm: Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose.~Then repeated 24 hours later."
186871|NCT01612221|O1|Outcome|Patients Receiving N-acetylcysteine|"Patients receiving NAC (N-acetylcysteine)~N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses"
186872|NCT01612221|E2|Reported Event|Placebo Group|"Participants not receiving NAC (N-acetylcysteine)~Placebo arm: Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose.~Then repeated 24 hours later."
194312|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
186873|NCT01612221|E1|Reported Event|Patients Receiving N-acetylcysteine|"Patients receiving NAC (N-acetylcysteine)~N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses"
186874|NCT01612156|B3|Baseline|Total|Total of all reporting groups
186875|NCT01612156|B2|Baseline|Water Based Lubricant|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.~Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination."
186876|NCT01612156|B1|Baseline|2% Lidocaine Gel|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.~2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination."
186877|NCT01612156|P2|Participant Flow|Water Based Lubricant|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.~Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination."
186878|NCT01612156|P1|Participant Flow|2% Lidocaine Gel|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.~2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination."
186879|NCT01612156|O2|Outcome|Water Based Lubricant|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.~Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination."
186880|NCT01612156|O1|Outcome|2% Lidocaine Gel|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.~2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination."
186881|NCT01612156|O2|Outcome|Water Based Lubricant|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.~Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination."
186882|NCT01612156|O1|Outcome|2% Lidocaine Gel|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.~2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination."
186883|NCT01612156|E2|Reported Event|Water Based Lubricant|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.~Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination."
186884|NCT01612156|E1|Reported Event|2% Lidocaine Gel|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.~2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination."
186885|NCT01612000|B5|Baseline|Total|Total of all reporting groups
186886|NCT01612000|B4|Baseline|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
186887|NCT01612000|B3|Baseline|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection"
186888|NCT01612000|B2|Baseline|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
186889|NCT01612000|B1|Baseline|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
186890|NCT01612000|P4|Participant Flow|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
186891|NCT01612000|P3|Participant Flow|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection"
186892|NCT01612000|P2|Participant Flow|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
186893|NCT01612000|P1|Participant Flow|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
186894|NCT01612000|O4|Outcome|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
186895|NCT01612000|O3|Outcome|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection"
186896|NCT01612000|O2|Outcome|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
186897|NCT01612000|O1|Outcome|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
186928|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186898|NCT01612000|O4|Outcome|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
186899|NCT01612000|O3|Outcome|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection"
186900|NCT01612000|O2|Outcome|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
186901|NCT01612000|O1|Outcome|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
186902|NCT01612000|O4|Outcome|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
186903|NCT01612000|O3|Outcome|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection"
186904|NCT01612000|O2|Outcome|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
186905|NCT01612000|O1|Outcome|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
186906|NCT01612000|O4|Outcome|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
186907|NCT01612000|O3|Outcome|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection"
186908|NCT01612000|O2|Outcome|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
186909|NCT01612000|O1|Outcome|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
186910|NCT01612000|E4|Reported Event|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
186911|NCT01612000|E3|Reported Event|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection"
186912|NCT01612000|E2|Reported Event|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
186913|NCT01612000|E1|Reported Event|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
186914|NCT01611974|B4|Baseline|Total|Total of all reporting groups
186915|NCT01611974|B3|Baseline|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186916|NCT01611974|B2|Baseline|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186917|NCT01611974|B1|Baseline|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186918|NCT01611974|P3|Participant Flow|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186919|NCT01611974|P2|Participant Flow|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186920|NCT01611974|P1|Participant Flow|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186921|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186922|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186923|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186924|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186925|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186926|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186927|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186969|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
194313|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
186929|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186930|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186931|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186932|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186933|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186934|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186935|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186936|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186937|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186938|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186939|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186940|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186941|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186942|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186943|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186944|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186945|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186946|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186947|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186948|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186949|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186950|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186951|NCT01611974|E3|Reported Event|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186952|NCT01611974|E2|Reported Event|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186953|NCT01611974|E1|Reported Event|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
186954|NCT01611948|B3|Baseline|Total|Total of all reporting groups
186955|NCT01611948|B2|Baseline|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
186956|NCT01611948|B1|Baseline|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
186957|NCT01611948|P2|Participant Flow|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
186958|NCT01611948|P1|Participant Flow|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
186959|NCT01611948|O2|Outcome|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
186960|NCT01611948|O1|Outcome|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
186961|NCT01611948|E2|Reported Event|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
186962|NCT01611948|E1|Reported Event|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
186963|NCT01611883|B3|Baseline|Total|Total of all reporting groups
186964|NCT01611883|B2|Baseline|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
186965|NCT01611883|B1|Baseline|Ezetimibe|10 mg oral dose once daily for 24 weeks
186966|NCT01611883|P2|Participant Flow|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
186967|NCT01611883|P1|Participant Flow|Ezetimibe|10 mg oral dose once daily for 24 weeks
186968|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
186972|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
186973|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
186974|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
186975|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
186976|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
186977|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
186978|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
186979|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
186980|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
186981|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
186982|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
186983|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
186984|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
186985|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
186986|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
186987|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
186988|NCT01611883|E2|Reported Event|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
186989|NCT01611883|E1|Reported Event|Ezetimibe|10 mg oral dose once daily for 24 weeks
186990|NCT01611857|B3|Baseline|Total|Total of all reporting groups
186991|NCT01611857|B2|Baseline|Tivantinib+FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 2-week cycle;~FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 2-week cycle.~Treatment continued until disease progression or unacceptable toxicity."
186992|NCT01611857|B1|Baseline|Tivantinib+FOLFOX Dose Escalation|"Tivantinib: (120 mg, 240 mg, or 360 mg) orally, twice daily on Days 1-14 of each 2 week cycle.~FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 each cycle."
186993|NCT01611857|P2|Participant Flow|Tivantinib + FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 2-week cycle.~FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 2-week cycle."
186994|NCT01611857|P1|Participant Flow|Tivantinib + FOLFOX Dose Escalation|"Tivantinib: (120 mg; 240 mg; or 360 mg) orally, twice daily (PO BID) on Days 1-14 of each 2 week cycle;~FOLFOX: [5-Fluorouracil (5-FU) 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2] on Day 1 each cycle."
186995|NCT01611857|O1|Outcome|Tivantinib + FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 14-day cycle. FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 14-day cycle.~Treatment continued until disease progression or unacceptable toxicity."
186996|NCT01611857|O1|Outcome|Tivantinib + FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 14-day cycle. FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 14-day cycle.~Treatment continued until disease progression or unacceptable toxicity."
186997|NCT01611857|O1|Outcome|Tivantinib + FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 14-day cycle. FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 14-day cycle.~Treatment continued until disease progression or unacceptable toxicity."
186998|NCT01611857|O3|Outcome|Tivantinib 360 mg (PO BID) + FOLFOX|"Tivantinib 360 mg given orally, twice daily (PO BID) on Days 1-14 of each 14-day cycle cycle;~FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 each cycle."
186999|NCT01611857|O2|Outcome|Tivantinib 240 mg (PO BID) + FOLFOX|"Tivantinib 240 mg given orally, twice daily (PO BID) on Days 1-14 of each 14-day cycle;~FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 each cycle."
187000|NCT01611857|O1|Outcome|Tivantinib 120 mg (PO BID) + FOLFOX|"Tivantinib 120 mg given orally, twice daily (PO BID) on Days 1-14 of each 14-day cycle;~FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 each cycle."
187001|NCT01611857|E2|Reported Event|Tivantinib+FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 2-week cycle. FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 2-week cycle.~Treatment continued until disease progression or unacceptable toxicity."
187002|NCT01611857|E1|Reported Event|Tivantinib+FOLFOX Dose Escalation|Tivantinib: orally, twice daily (PO BID) on Days 1-14 of each 2 week cycle; FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 each cycle.
187003|NCT01611792|B3|Baseline|Total|Total of all reporting groups
187004|NCT01611792|B2|Baseline|Strengthening and Conditioning|Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
187045|NCT01611571|O3|Outcome|Placebo Risedronate Active Teriparatide|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
187046|NCT01611571|O2|Outcome|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
187005|NCT01611792|B1|Baseline|Stabilization|"Stabilization~Stabilization exercise protocol: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities."
187006|NCT01611792|P2|Participant Flow|Strengthening and Conditioning|Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
187007|NCT01611792|P1|Participant Flow|Low Back Pain|"Stabilization~Stabilization exercise protocol: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities."
187008|NCT01611792|O2|Outcome|Strengthening and Conditioning|Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
187009|NCT01611792|O1|Outcome|Stabilization|Stabilization exercise protocol: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities.
187010|NCT01611792|O2|Outcome|Strengthening and Conditioning|Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
187011|NCT01611792|O1|Outcome|Stabilization|Stabilization exercise protocol: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities.
187012|NCT01611792|O2|Outcome|Strengthening and Conditioning|Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
187013|NCT01611792|O1|Outcome|Stabilization|Stabilization exercise protocol: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities.
187014|NCT01611792|O2|Outcome|Strengthening and Conditioning|Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
187015|NCT01611792|O1|Outcome|Stabilization|Stabilization exercise protocol: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities.
187016|NCT01611792|O2|Outcome|Strengthening and Conditioning|Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
187017|NCT01611792|O1|Outcome|Stabilization|"Stabilization~Stabilization exercise protocol: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities."
187018|NCT01611792|O2|Outcome|Strengthening and Conditioning|Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
187019|NCT01611792|O1|Outcome|Stabilization|"Stabilization~Stabilization exercise protocol: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities."
187020|NCT01611792|E2|Reported Event|Strengthening and Conditioning|Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
187021|NCT01611792|E1|Reported Event|Stabilization|"Stabilization~Stabilization exercise protocol: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities."
187022|NCT01611779|B1|Baseline|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
187023|NCT01611779|P1|Participant Flow|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
187024|NCT01611779|O1|Outcome|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
187025|NCT01611779|O1|Outcome|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
187026|NCT01611779|O1|Outcome|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
187027|NCT01611779|O1|Outcome|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
187028|NCT01611779|O1|Outcome|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
187029|NCT01611779|O1|Outcome|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
187030|NCT01611779|E1|Reported Event|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
187031|NCT01611662|B1|Baseline|Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy.~gemcitabine hydrochloride: Given IV~cisplatin: Given IV~therapeutic conventional surgery: Undergo radical cystectomy~laboratory biomarker analysis: Correlative studies"
187032|NCT01611662|P1|Participant Flow|Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy.~gemcitabine hydrochloride: Given IV~cisplatin: Given IV~therapeutic conventional surgery: Undergo radical cystectomy~laboratory biomarker analysis: Correlative studies"
187033|NCT01611662|O1|Outcome|Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy.~gemcitabine hydrochloride: Given IV~cisplatin: Given IV~therapeutic conventional surgery: Undergo radical cystectomy~laboratory biomarker analysis: Correlative studies"
187034|NCT01611662|E1|Reported Event|Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy.~gemcitabine hydrochloride: Given IV~cisplatin: Given IV~therapeutic conventional surgery: Undergo radical cystectomy~laboratory biomarker analysis: Correlative studies"
187035|NCT01611571|B4|Baseline|Total|Total of all reporting groups
187036|NCT01611571|B3|Baseline|Placebo Risedronate Active Teriparatide, Active Risedronate|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
187037|NCT01611571|B2|Baseline|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
187038|NCT01611571|B1|Baseline|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
187039|NCT01611571|P3|Participant Flow|Placebo Risedronate + Active Teriparatide, Active Risedronate|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
187040|NCT01611571|P2|Participant Flow|Active Risedronte + Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
187041|NCT01611571|P1|Participant Flow|Active Risedronate + Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
187042|NCT01611571|O3|Outcome|Placebo Risedronate Active Teriparatide|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
187043|NCT01611571|O2|Outcome|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
187044|NCT01611571|O1|Outcome|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
187047|NCT01611571|O1|Outcome|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
187048|NCT01611571|O3|Outcome|Placebo Risedronate Active Teriparatide|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
187049|NCT01611571|O2|Outcome|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
187050|NCT01611571|O1|Outcome|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
187051|NCT01611571|O3|Outcome|Placebo Risedronate Active Teriparatide|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
187052|NCT01611571|O2|Outcome|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
187053|NCT01611571|O1|Outcome|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
187054|NCT01611571|O3|Outcome|Placebo Risedronate Active Teriparatide|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
187055|NCT01611571|O2|Outcome|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
187056|NCT01611571|O1|Outcome|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
187057|NCT01611571|E3|Reported Event|Placebo Risedronate Active Teriparatide, Active Risedronate|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
187058|NCT01611571|E2|Reported Event|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
187059|NCT01611571|E1|Reported Event|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
187060|NCT01611558|B1|Baseline|Ipilimumab,10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
187061|NCT01611558|P1|Participant Flow|Ipilimumab, 10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
187062|NCT01611558|O1|Outcome|Ipilimumab,10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
187063|NCT01611558|O1|Outcome|Ipilimumab,10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
187064|NCT01611558|O1|Outcome|Ipilimumab, 10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
187065|NCT01611558|E1|Reported Event|Ipilimumab, 10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
187066|NCT01611259|B1|Baseline|Rituximab and Lenalidomide|Rituximab was administered on day 1 of each cycle in a dose of 375 mg/m² (28 day cycle). Dose of lenalidomide for investigation is 20 mg/day, orally on days 1 to 21 followed by 7 days pause.Restaging should be performed after three cycles. In case of at least stable disease, patients should receive another three courses of therapy. Patients with documented CR after 6 courses stopped therapy/study, while patients with PR or SD were given another two cycles for a maximum of 8 cycles.
187067|NCT01611259|P1|Participant Flow|Rituximab and Lenalidomide|Rituximab was administered on day 1 of each cycle in a dose of 375 mg/m² (28 day cycle). Dose of lenalidomide for investigation is 20 mg/day, orally on days 1 to 21 followed by 7 days pause.Restaging should be performed after three cycles. In case of at least stable disease, patients should receive another three courses of therapy. Patients with documented CR after 6 courses stopped therapy/study, while patients with PR or SD were given another two cycles for a maximum of 8 cycles.
187068|NCT01611259|O1|Outcome|Rituximab and Lenalidomide|Rituximab was administered on day 1 of each cycle in a dose of 375 mg/m² (28 day cycle). Dose of lenalidomide for investigation is 20 mg/day, orally on days 1 to 21 followed by 7 days pause.Restaging should be performed after three cycles. In case of at least stable disease, patients should receive another three courses of therapy. Patients with documented CR after 6 courses stopped therapy/study, while patients with PR or SD were given another two cycles for a maximum of 8 cycles.
187069|NCT01611259|E1|Reported Event|Rituximab and Lenalidomide|Rituximab was administered on day 1 of each cycle in a dose of 375 mg/m² (28 day cycle). Dose of lenalidomide for investigation is 20 mg/day, orally on days 1 to 21 followed by 7 days pause.Restaging should be performed after three cycles. In case of at least stable disease, patients should receive another three courses of therapy. Patients with documented CR after 6 courses stopped therapy/study, while patients with PR or SD were given another two cycles for a maximum of 8 cycles.
187070|NCT01610791|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
187071|NCT01610791|P1|Participant Flow|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 milligrams per kilogram (mg/kg), intravenously (IV), once every 4 weeks for a total of 6 infusions.
187072|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
187073|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
188833|NCT01605877|O6|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
187074|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
187075|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
187076|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
187077|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
187078|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
187079|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
187080|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
187081|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
187082|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
187083|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
187084|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
187085|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
187086|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
187087|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
187088|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
187089|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
187090|NCT01610791|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
187091|NCT01610713|B3|Baseline|Total|Total of all reporting groups
187092|NCT01610713|B2|Baseline|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187093|NCT01610713|B1|Baseline|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187094|NCT01610713|P2|Participant Flow|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187095|NCT01610713|P1|Participant Flow|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187096|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187097|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187098|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187099|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187100|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187101|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
194314|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
187102|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187103|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187104|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187105|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187106|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187107|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187108|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187109|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187110|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187111|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187112|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187113|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187114|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187115|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187116|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187117|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187538|NCT01609582|B2|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
187118|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187119|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187120|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187121|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187122|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187123|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187124|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187125|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187126|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187127|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187128|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187129|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187130|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187131|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187132|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187133|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187539|NCT01609582|B1|Baseline|Placebo|Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
187134|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187135|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187136|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187137|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187138|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187139|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187140|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187141|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187142|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187143|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187144|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187145|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187146|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187147|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187148|NCT01610713|E2|Reported Event|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187149|NCT01610713|E1|Reported Event|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187150|NCT01610700|B3|Baseline|Total|Total of all reporting groups
187151|NCT01610700|B2|Baseline|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187152|NCT01610700|B1|Baseline|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187153|NCT01610700|P2|Participant Flow|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187154|NCT01610700|P1|Participant Flow|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187155|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187156|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187157|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187158|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187159|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187160|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187161|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187162|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187163|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187164|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187165|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187166|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187167|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187168|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187169|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187170|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187171|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187172|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187173|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187174|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187175|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187176|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187177|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187178|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187179|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187180|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187181|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187182|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187183|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187288|NCT01610557|O1|Outcome|Bevacizumab|Represents the estimated effect of bevacizumab for a 3-month period, adjusted for period and baseline value.
194315|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
187184|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187185|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187186|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187187|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187188|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187189|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187190|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187191|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187192|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187193|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187194|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187195|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187196|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187197|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187198|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187199|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187200|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187201|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187202|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187203|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187204|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187205|NCT01610700|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
187206|NCT01610700|E1|Reported Event|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
187207|NCT01610687|B1|Baseline|GW-1000-02|Active treatment
187208|NCT01610687|P1|Participant Flow|GW-1000-02|GW-1000-02 contains Δ tetrahydrocannabinol, 27 mg/ml and cannabidiol, 25 mg/ml as extract of Cannabis sativa L. Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
187209|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
187210|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
187211|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
187212|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
187213|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
187214|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
187215|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
187216|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
187217|NCT01610687|E1|Reported Event|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
187218|NCT01610596|B3|Baseline|Total|Total of all reporting groups
187219|NCT01610596|B2|Baseline|Vehicle Lotion|"Topical lotion, applied twice daily~Placebo"
187220|NCT01610596|B1|Baseline|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily~Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week"
187221|NCT01610596|P2|Participant Flow|Vehicle Lotion|"Topical lotion, applied twice daily~Placebo"
187222|NCT01610596|P1|Participant Flow|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily~Halobetasol Propionate Lotion 0.05%: Apply twice daily for 2 weeks, not to exceed 50 grams per week"
187223|NCT01610596|O2|Outcome|Vehicle Lotion|"Topical lotion, applied twice daily~Placebo"
187224|NCT01610596|O1|Outcome|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily~Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week"
187225|NCT01610596|O2|Outcome|Vehicle Lotion|"Topical lotion, applied twice daily~Placebo"
187226|NCT01610596|O1|Outcome|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily~Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week"
187227|NCT01610596|O2|Outcome|Vehicle Lotion|"Topical lotion, applied twice daily~Placebo"
187228|NCT01610596|O1|Outcome|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily~Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week"
187229|NCT01610596|O2|Outcome|Vehicle Lotion|"Topical lotion, applied twice daily~Placebo"
187230|NCT01610596|O1|Outcome|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily~Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week"
187231|NCT01610596|E2|Reported Event|Vehicle Lotion|"Topical lotion, applied twice daily~Placebo"
187232|NCT01610596|E1|Reported Event|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily~Halobetasol Propionate Lotion 0.05%: Apply twice daily for 2 weeks, not to exceed 50 grams per week"
187233|NCT01610570|B5|Baseline|Total|Total of all reporting groups
187234|NCT01610570|B4|Baseline|Phase 2|Expansion phase 17.5 mcg/kg.dose Mithramycin: Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously.
187235|NCT01610570|B3|Baseline|Phase I Dose Level 2|Dose Escalation Phase 17.5 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously
187236|NCT01610570|B2|Baseline|Phase 1 Dose Level 1|Dose Escalation Phase 13.0 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously
187237|NCT01610570|B1|Baseline|Phase I Dose Level -1|Dose Escalation Phase 9.0 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously
187289|NCT01610557|E7|Reported Event|Ranibizumab and Bevacizumab As Needed (Post-36-Week Extension)|"Post-36-Week Extension Phase: Eyes assigned to Group 1 or Group 2 in the crossover phase were injected with ranibizumab on an as-needed basis. Eyes assigned to Group 3 or Group 4 in the crossover phase were injected with bevacizumab on an as-needed basis.~Participants with two eyes assigned who had at least one follow-up visit in the post-36-week extension are included in the number of participants at risk.~Participants for whom one eye was assigned (unilateral participants) are not included."
187357|NCT01610414|O2|Outcome|Placebo Group|Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187238|NCT01610570|P4|Participant Flow|Phase II - Expansion Phase|Expansion phase 17.5 mcg/kg.dose Mithramycin: Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously.
187239|NCT01610570|P3|Participant Flow|Phase 1 Dose Level 2|"Dose Escalation Phase~17.5 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously"
187240|NCT01610570|P2|Participant Flow|Phase 1 Dose Level 1|"Dose Escalation Phase~13.0 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously"
187241|NCT01610570|P1|Participant Flow|Phase I Dose Level -1|"Dose Escalation Phase~9.0 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously"
187242|NCT01610570|O3|Outcome|Phase II - Expansion Phase|Expansion phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187243|NCT01610570|O2|Outcome|Phase I Dose Level 2|Dose Escalation Phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187244|NCT01610570|O1|Outcome|Phase I Dose Level 1|Dose Escalation Phase 13.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187245|NCT01610570|O1|Outcome|Phase I Dose Level 1 & Phase II Expansion Phase|Dose levels 13.0 and 17.5 mcg/kg. dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187503|NCT01610037|E3|Reported Event|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
187246|NCT01610570|O1|Outcome|Phase I Dose Level 1 & Phase II Expansion Phase|Dose levels 13.0 and 17.5 mcg/kg. dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187247|NCT01610570|O1|Outcome|Phase I Dose Level 1 & Phase II Expansion Phase|Dose levels 13.0 and 17.5 mcg/kg. dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187248|NCT01610570|O1|Outcome|Phase I Dose Level 1 & Phase II Expansion Phase|Dose levels 13.0 and 17.5 mcg/kg. dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187249|NCT01610570|O1|Outcome|Phase I Dose Level 1 & Phase II Expansion Phase|Dose levels 13.0 and 17.5 mcg/kg. dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187250|NCT01610570|O1|Outcome|Phase I Dose Level 1 & Phase II Expansion Phase|Dose levels 13.0 and 17.5 mcg/kg. dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187251|NCT01610570|O3|Outcome|Phase II - Expansion Phase|Expansion phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187252|NCT01610570|O2|Outcome|Phase I Dose Level 2|Dose Escalation Phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187309|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187253|NCT01610570|O1|Outcome|Phase I Dose Level 1|Dose Escalation Phase 13.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187254|NCT01610570|O3|Outcome|Phase II - Expansion Phase|Expansion phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187255|NCT01610570|O2|Outcome|Phase I Dose Level 2|Dose Escalation Phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187256|NCT01610570|O1|Outcome|Phase I Dose Level 1|Dose Escalation Phase 13.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187257|NCT01610570|O3|Outcome|Phase II - Expansion Phase|Expansion phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187258|NCT01610570|O2|Outcome|Phase I Dose Level 2|Dose Escalation Phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187259|NCT01610570|O1|Outcome|Phase I Dose Level 1|Dose Escalation Phase 13.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187290|NCT01610557|E6|Reported Event|Bevacizumab As Needed (Post-36-Week Extension)|"Post-36-Week Extension Phase: Eyes assigned to Group 3 or Group 4 in the crossover phase were injected with bevacizumab on an as-needed basis.~Participants with one eye assigned in either Group 3 or Group 4 who had at least one follow-up visit in the post-36-week extension are included in the number of participants at risk.~Participants for whom two eyes were assigned (bilateral participants) are not included."
194316|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
187260|NCT01610570|O3|Outcome|Phase II - Expansion Phase|Expansion phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187261|NCT01610570|O2|Outcome|Phase I Dose Level 2|Dose Escalation Phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187262|NCT01610570|O1|Outcome|Phase I Dose Level 1|Dose Escalation Phase 13.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187263|NCT01610570|O1|Outcome|Phase II - Expansion Phase|Expansion phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187264|NCT01610570|O4|Outcome|Phase II - Expansion Phase|Expansion phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187265|NCT01610570|O3|Outcome|Phase I Dose Level 2|Dose Escalation Phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187266|NCT01610570|O2|Outcome|Phase I Dose Level 1|Dose Escalation Phase 13.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187291|NCT01610557|E5|Reported Event|Ranibizumab As Needed (Post-36-Week Extension)|"Post-36-Week Extension Phase: Eyes assigned to Group 1 or Group 2 in the crossover phase were injected with ranibizumab on an as-needed basis.~Participants with one eye assigned in either Group 1 or Group 2 who had at least one follow-up visit in the post-36-week extension are included in the number of participants at risk.~Participants for whom two eyes were assigned (bilateral participants) are not included."
194317|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
187267|NCT01610570|O1|Outcome|Phase I Dose Level -1|Dose Escalation Phase 9.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187268|NCT01610570|O3|Outcome|Phase I Dose Level 2|Dose Escalation Phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187269|NCT01610570|O2|Outcome|Phase I Dose Level 1|Dose Escalation Phase 13.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187270|NCT01610570|O1|Outcome|Phase I Dose Level -1|Dose Escalation Ph 9.0 mcg/kg dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187271|NCT01610570|E4|Reported Event|Phase II - Expansion Phase|Expansion phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187272|NCT01610570|E3|Reported Event|Phase I Dose Level 2|Dose Escalation Phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187273|NCT01610570|E2|Reported Event|Phase I Dose Level 1|Dose Escalation Phase 13.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187308|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187504|NCT01610037|E2|Reported Event|Tiotropium|18 μg capsules for inhalation, o.d
187274|NCT01610570|E1|Reported Event|Phase I Dose Level -1|Dose Escalation Phase 9.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
187275|NCT01610557|B5|Baseline|Total|Total of all reporting groups
187276|NCT01610557|B4|Baseline|Group 4 - Bevacizumab-Ranibizumab-Ranibizumab Injection Series|"Group 4 eyes were assigned to Bevacizumab-Ranibizumab-Ranibizumab (BRR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of ranibizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
187277|NCT01610557|B3|Baseline|Group 3 - Bevacizumab-Bevacizumab-Ranibizumab Injection Series|"Group 3 eyes were assigned to Bevacizumab-Bevacizumab-Ranibizumab (BBR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4, 8, 12, 16 and 20 (periods 1 and 2), then crossed over to receive intravitreal injections of ranibizumab at Weeks 24, 28 and 32 (period 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
187278|NCT01610557|B2|Baseline|Group 2 - Ranibizumab-Bevacizumab-Bevacizumab Injection Series|"Group 2 eyes were assigned to Ranibizumab-Bevacizumab-Bevacizumab (RBB) treatment sequence and received intravitreal injections of ranibizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of bevacizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
187279|NCT01610557|B1|Baseline|Group 1 - Ranibizumab-Ranibizumab-Bevacizumab Injection Series|"Group 1 eyes were assigned to Ranibizumab-Ranibizumab-Bevacizumab (RRB) treatment sequence and received intravitreal injections of ranibizumab at baseline, Weeks 4, and 8 (period 1), and Weeks 12, 16 and 20 (period 2), then crossed over to receive intravitreal injections of bevacizumab at Weeks 24, 28 and 32 (period 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
187280|NCT01610557|P5|Participant Flow|Ranibizumab/Bevacizumab As Needed|"Post-36-Week Extension Phase: Eyes assigned to Group 1 or Group 2 in the crossover phase were injected with ranibizumab on an as-needed basis. Eyes assigned to Group 3 or Group 4 in the crossover phase were injected with bevacizumab on an as-needed basis.~53 participants attended at least one follow-up visit in the post-36-week extension phase: 49 participants who had one eye enrolled and 4 participants who had two eyes enrolled."
187281|NCT01610557|P4|Participant Flow|Group 4 - Bevacizumab-Ranibizumab-Ranibizumab Injection Series|"Group 4 eyes were assigned to Bevacizumab-Ranibizumab-Ranibizumab (BRR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of ranibizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
187282|NCT01610557|P3|Participant Flow|Group 3 - Bevacizumab-Bevacizumab-Ranibizumab Injection Series|"Group 3 eyes were assigned to Bevacizumab-Bevacizumab-Ranibizumab (BBR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4, 8, 12, 16 and 20 (periods 1 and 2), then crossed over to receive intravitreal injections of ranibizumab at Weeks 24, 28 and 32 (period 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
187283|NCT01610557|P2|Participant Flow|Group 2 - Ranibizumab-Bevacizumab-Bevacizumab Injection Series|"Group 2 eyes were assigned to Ranibizumab-Bevacizumab-Bevacizumab (RBB) treatment sequence and received intravitreal injections of ranibizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of bevacizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
187284|NCT01610557|P1|Participant Flow|Group 1 - Ranibizumab-Ranibizumab-Bevacizumab Injection Series|"Group 1 eyes were assigned to Ranibizumab-Ranibizumab-Bevacizumab (RRB) treatment sequence and received intravitreal injections of ranibizumab at baseline, Weeks 4, and 8 (period 1), and Weeks 12, 16 and 20 (period 2), then crossed over to receive intravitreal injections of bevacizumab at Weeks 24, 28 and 32 (period 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
187285|NCT01610557|O2|Outcome|Ranibizumab|Represents the estimated effect of ranibizumab for a 3-month period, adjusted for period and baseline value.
187286|NCT01610557|O1|Outcome|Bevacizumab|Represents the estimated effect of bevacizumab for a 3-month period, adjusted for period and baseline value.
187287|NCT01610557|O2|Outcome|Ranibizumab|Represents the estimated effect of ranibizumab for a 3-month period, adjusted for period and baseline value.
194318|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
187292|NCT01610557|E4|Reported Event|Group 4 - Bevacizumab-Ranibizumab-Ranibizumab Injection Series|"Group 4 eyes were assigned to Bevacizumab-Ranibizumab-Ranibizumab (BRR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of ranibizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
187293|NCT01610557|E3|Reported Event|Group 3 - Bevacizumab-Bevacizumab-Ranibizumab Injection Series|"Group 3 eyes were assigned to Bevacizumab-Bevacizumab-Ranibizumab (BBR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4, 8, 12, 16 and 20 (periods 1 and 2), then crossed over to receive intravitreal injections of ranibizumab at Weeks 24, 28 and 32 (period 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
187294|NCT01610557|E2|Reported Event|Group 2 - Ranibizumab-Bevacizumab-Bevacizumab Injection Series|"Group 2 eyes were assigned to Ranibizumab-Bevacizumab-Bevacizumab (RBB) treatment sequence and received intravitreal injections of ranibizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of bevacizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
187295|NCT01610557|E1|Reported Event|Group 1 - Ranibizumab-Ranibizumab-Bevacizumab Injection Series|"Group 1 eyes were assigned to Ranibizumab-Ranibizumab-Bevacizumab (RRB) treatment sequence and received intravitreal injections of ranibizumab at baseline, Weeks 4, and 8 (period 1), and Weeks 12, 16 and 20 (period 2), then crossed over to receive intravitreal injections of bevacizumab at Weeks 24, 28 and 32 (period 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
187296|NCT01610492|B1|Baseline|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187297|NCT01610492|P1|Participant Flow|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187298|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187299|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187300|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187301|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187302|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187303|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187304|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187305|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187306|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187307|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187355|NCT01610414|O2|Outcome|Placebo Group|Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187310|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187311|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187312|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187313|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187314|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187315|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187316|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187317|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187318|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187319|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187320|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187321|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187322|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187323|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187324|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187325|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187326|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187327|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187328|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187356|NCT01610414|O1|Outcome|GSK1437173A Group|Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187329|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187330|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187331|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187332|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187333|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187334|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187335|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187336|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187337|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187338|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187339|NCT01610492|E1|Reported Event|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
187340|NCT01610453|B1|Baseline|Transperineal Ultrasound|Fetal head descent was assessed using a transperineal scan
187341|NCT01610453|P1|Participant Flow|Results From Transperineal Scan|"Primiparous women with prolonged labours was eligible for the study. Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK and Department of Obstetrics and Gynecology, Stavanger University Hospital, Stavanger, Norway participated.~Ultrasound examination: a transperineal sonography was done when prolonged labor was diagnosed. Prolonged labor was diagnosed in accordance with WHO recommendations in Stavanger and in accordance with NICE guidelines in Cambridge"
187342|NCT01610453|O1|Outcome|Transabdominal Ultrasound|Fetal head position was assessed using a transabdominal scan
187343|NCT01610453|O1|Outcome|Transperineal Ultrasound|Fetal head descent was assessed using a transperineal scan
187344|NCT01610453|E1|Reported Event|Transabdominal and Transperineal Sonography|Fetal head position was assessed using a transabdominal scan and fetal station was assessed by transperineal scan
187345|NCT01610414|B3|Baseline|Total|Total of all reporting groups
187346|NCT01610414|B2|Baseline|Placebo Group|Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187347|NCT01610414|B1|Baseline|GSK1437173A Group|Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187348|NCT01610414|P2|Participant Flow|Placebo Group|Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187349|NCT01610414|P1|Participant Flow|GSK1437173A Group|Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187350|NCT01610414|O3|Outcome|No Group|Subjects who were not assigned to any group (subjects from pre-vaccination visit).
187351|NCT01610414|O2|Outcome|Placebo Group|Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187352|NCT01610414|O1|Outcome|GSK1437173A Group|Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187353|NCT01610414|O2|Outcome|Placebo Group|Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187354|NCT01610414|O1|Outcome|GSK1437173A Group|Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187358|NCT01610414|O1|Outcome|GSK1437173A Group|Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187359|NCT01610414|O2|Outcome|Placebo Group|Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187360|NCT01610414|O1|Outcome|GSK1437173A Group|Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187361|NCT01610414|O2|Outcome|Placebo Group|Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187362|NCT01610414|O1|Outcome|GSK1437173A Group|Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187363|NCT01610414|O2|Outcome|Placebo Group|Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187364|NCT01610414|O1|Outcome|GSK1437173A Group|Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187365|NCT01610414|O2|Outcome|Placebo Group|Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187366|NCT01610414|O1|Outcome|GSK1437173A Group|Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187367|NCT01610414|O2|Outcome|Placebo Group|Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187368|NCT01610414|O1|Outcome|GSK1437173A Group|Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187369|NCT01610414|O2|Outcome|Placebo Group|Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187370|NCT01610414|O1|Outcome|GSK1437173A Group|Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187371|NCT01610414|O2|Outcome|Placebo Group|Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187372|NCT01610414|O1|Outcome|GSK1437173A Group|Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187373|NCT01610414|O2|Outcome|Placebo Group|Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187374|NCT01610414|O1|Outcome|GSK1437173A Group|Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187375|NCT01610414|E2|Reported Event|Placebo Group|Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187376|NCT01610414|E1|Reported Event|GSK1437173A Group|Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
187377|NCT01610297|B1|Baseline|ICL670|Oral dose of ICL670 at 10 mg/kg daily
187378|NCT01610297|P1|Participant Flow|ICL670|Oral dose of ICL670 at 10 mg/kg daily
187379|NCT01610297|O1|Outcome|ICL670|Oral dose of ICL670 at 10 mg/kg daily
187380|NCT01610297|O1|Outcome|ICL670|Oral dose of ICL670 at 10 mg/kg daily
187381|NCT01610297|O1|Outcome|ICL670|Oral dose of ICL670 at 10 mg/kg daily
187382|NCT01610297|O1|Outcome|ICL670|Oral dose of ICL670 at 10 mg/kg daily
187383|NCT01610297|O1|Outcome|ICL670|Oral dose of ICL670 at 10 mg/kg daily
187384|NCT01610297|E1|Reported Event|ICL670|Oral dose of ICL670 at 10 mg/kg daily
187385|NCT01610167|B4|Baseline|Total|Total of all reporting groups
187386|NCT01610167|B3|Baseline|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
187387|NCT01610167|B2|Baseline|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
187388|NCT01610167|B1|Baseline|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
187389|NCT01610167|P3|Participant Flow|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
187390|NCT01610167|P2|Participant Flow|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
187391|NCT01610167|P1|Participant Flow|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
187392|NCT01610167|O3|Outcome|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
187393|NCT01610167|O2|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
187394|NCT01610167|O1|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
187395|NCT01610167|O3|Outcome|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
187396|NCT01610167|O2|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
187397|NCT01610167|O1|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
187398|NCT01610167|O3|Outcome|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
187399|NCT01610167|O2|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
187400|NCT01610167|O1|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
187401|NCT01610167|O3|Outcome|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
187402|NCT01610167|O2|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
187403|NCT01610167|O1|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
187404|NCT01610167|O3|Outcome|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
187405|NCT01610167|O2|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
187406|NCT01610167|O1|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
187407|NCT01610167|E3|Reported Event|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
187408|NCT01610167|E2|Reported Event|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
187409|NCT01610167|E1|Reported Event|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
187410|NCT01610154|B1|Baseline|Sitagliptin Treatment|Sitagliptin 100 mg QD for 12 weeks
187411|NCT01610154|P1|Participant Flow|Sitagliptin Treatment|Sitagliptin 100 mg QD for 12 weeks
187412|NCT01610154|O2|Outcome|Obese Group|BMI≥25 kg/m2
187413|NCT01610154|O1|Outcome|Non-obese Group|BMI<25 kg/m2
187414|NCT01610154|O1|Outcome|Sitagliptin|Sitagliptin 100 mg QD
187415|NCT01610154|O2|Outcome|Obese Group|BMI≥25 kg/m2
187416|NCT01610154|O1|Outcome|Non-obese Group|BMI<25 kg/m2
187417|NCT01610154|O1|Outcome|Sitagliptin|Sitagliptin 100 mg QD
187418|NCT01610154|O2|Outcome|Obese Group|BMI≥25 kg/m2
187419|NCT01610154|O1|Outcome|Non-obese Group|BMI<25 kg/m2
187420|NCT01610154|O1|Outcome|Sitagliptin|Sitagliptin 100 mg QD
187421|NCT01610154|O1|Outcome|Sitagliptin|Sitagliptin 100 mg QD
187422|NCT01610154|O1|Outcome|Sitagliptin|Sitagliptin 100 mg QD
187423|NCT01610154|O1|Outcome|Sitagliptin|Sitagliptin 100 mg QD
187424|NCT01610154|E1|Reported Event|Sitagliptin Treatment|Sitagliptin 100 mg QD
187425|NCT01610076|B3|Baseline|Total|Total of all reporting groups
187426|NCT01610076|B2|Baseline|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration~Code Status Video: 10 minute video about Code Status"
187427|NCT01610076|B1|Baseline|No Video - Control|"This group does not watch the 10 minute code status video before having the knowledge base video administered."
187428|NCT01610076|P2|Participant Flow|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration~Code Status Video: 10 minute video about Code Status"
187429|NCT01610076|P1|Participant Flow|No Video - Control|"This group does not watch the 10 minute code status video before having the knowledge base video administered."
187430|NCT01610076|O1|Outcome|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration~Code Status Video: 10 minute video about Code Status"
187431|NCT01610076|O1|Outcome|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration~Code Status Video: 10 minute video about Code Status"
187432|NCT01610076|O1|Outcome|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration~Code Status Video: 10 minute video about Code Status"
187433|NCT01610076|O2|Outcome|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration~Code Status Video: 10 minute video about Code Status"
187434|NCT01610076|O1|Outcome|No Video - Control|"This group does not watch the 10 minute code status video before having the knowledge base video administered."
187435|NCT01610076|E2|Reported Event|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration~Code Status Video: 10 minute video about Code Status"
187436|NCT01610076|E1|Reported Event|No Video - Control|"This group does not watch the 10 minute code status video before having the knowledge base video administered."
187437|NCT01610063|B3|Baseline|Total|Total of all reporting groups
187438|NCT01610063|B2|Baseline|Unguided|Treatment as usual
187439|NCT01610063|B1|Baseline|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
187440|NCT01610063|P2|Participant Flow|Unguided|Treatment as usual
187441|NCT01610063|P1|Participant Flow|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
187442|NCT01610063|O2|Outcome|Unguided|Treatment as usual
187505|NCT01610037|E1|Reported Event|QVA 149|110/50 µg capsules for inhalation, o.d
187443|NCT01610063|O1|Outcome|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
187444|NCT01610063|O2|Outcome|Unguided|Treatment as usual
187445|NCT01610063|O1|Outcome|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
187446|NCT01610063|O2|Outcome|Unguided|Treatment as usual
187447|NCT01610063|O1|Outcome|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
187448|NCT01610063|O2|Outcome|Unguided|Treatment as usual
187449|NCT01610063|O1|Outcome|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
187450|NCT01610063|O2|Outcome|Unguided|Treatment as usual
187451|NCT01610063|O1|Outcome|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
187452|NCT01610063|O2|Outcome|Unguided|Treatment as usual
187453|NCT01610063|O1|Outcome|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
187454|NCT01610063|O2|Outcome|Unguided|Treatment as usual
187455|NCT01610063|O1|Outcome|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
187456|NCT01610063|O2|Outcome|Unguided|Treatment as usual
187457|NCT01610063|O1|Outcome|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
187458|NCT01610063|E2|Reported Event|Unguided|Treatment as usual
187459|NCT01610063|E1|Reported Event|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
187460|NCT01610037|B4|Baseline|Total|Total of all reporting groups
187461|NCT01610037|B3|Baseline|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
187462|NCT01610037|B2|Baseline|Tiotropium|18 μg capsules for inhalation, o.d
187463|NCT01610037|B1|Baseline|QVA149|110/50 µg capsules for inhalation, o.d
187464|NCT01610037|P3|Participant Flow|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
187465|NCT01610037|P2|Participant Flow|Tiotropium|18 μg capsules for inhalation, o.d
187466|NCT01610037|P1|Participant Flow|QVA149|110/50 µg capsules for inhalation, o.d
187467|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
187468|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
187469|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
187470|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
187471|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
187472|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
187473|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
187474|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
187475|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
187476|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
187477|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
187478|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
187479|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
187480|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
187481|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
187482|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
187483|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
187484|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
187485|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
187486|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
187487|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
187488|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
187489|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
187490|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
187491|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
187492|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
187493|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
187494|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
187495|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
187496|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
187497|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
187498|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
187499|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
187500|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
187501|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
187502|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
187506|NCT01610011|B3|Baseline|Total|Total of all reporting groups
187507|NCT01610011|B2|Baseline|Glycine Administration GLDC Subjects|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
187508|NCT01610011|B1|Baseline|Glycine Administration|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
187509|NCT01610011|P2|Participant Flow|Glycine Administration GLDC Mutation Subjects|Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics. Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage.
187510|NCT01610011|P1|Participant Flow|Glycine Administration|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
187511|NCT01610011|O2|Outcome|Glycine Administration GLDC Mutation Subjects|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
187512|NCT01610011|O1|Outcome|Glycine Administration Controls|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
187513|NCT01610011|E2|Reported Event|Glycine Administration GLDC Mutation Subjects|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
187514|NCT01610011|E1|Reported Event|Glycine Administration Controls|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
187515|NCT01609790|B4|Baseline|Total|Total of all reporting groups
187516|NCT01609790|B3|Baseline|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
187517|NCT01609790|B2|Baseline|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
187518|NCT01609790|B1|Baseline|Cohort 1: Safety Run-In|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
187519|NCT01609790|P3|Participant Flow|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
187520|NCT01609790|P2|Participant Flow|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
187521|NCT01609790|P1|Participant Flow|Cohort 1: Safety Run-In|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
187522|NCT01609790|O1|Outcome|Safety Run-In|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
187523|NCT01609790|O2|Outcome|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
187524|NCT01609790|O1|Outcome|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
187525|NCT01609790|O2|Outcome|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
187526|NCT01609790|O1|Outcome|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
187527|NCT01609790|O2|Outcome|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
187528|NCT01609790|O1|Outcome|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
187529|NCT01609790|O2|Outcome|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
187530|NCT01609790|O1|Outcome|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
187531|NCT01609790|O2|Outcome|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
187532|NCT01609790|O1|Outcome|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
187533|NCT01609790|O1|Outcome|Safety Run-In|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
187534|NCT01609790|E3|Reported Event|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
187535|NCT01609790|E2|Reported Event|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
187536|NCT01609790|E1|Reported Event|Cohort 1: Safety Run-In|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
187537|NCT01609582|B3|Baseline|Total|Total of all reporting groups
187540|NCT01609582|P2|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
187541|NCT01609582|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
187542|NCT01609582|O2|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
187543|NCT01609582|O1|Outcome|Placebo|Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
187544|NCT01609582|O2|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
187545|NCT01609582|O1|Outcome|Placebo|Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
187546|NCT01609582|E2|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
187547|NCT01609582|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
187548|NCT01609543|B1|Baseline|Erlotinib Hydrochloride|Participants received a single 150 mg oral dose of erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
187549|NCT01609543|P1|Participant Flow|Erlotinib Hydrochloride|Participants received a single 150 milligrams (mg) oral dose of erlotinib hydrochloride (Tarceva) tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
187550|NCT01609543|O1|Outcome|Erlotinib Hydrochloride|Participants received a single 150 mg oral dose of erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
187551|NCT01609543|O1|Outcome|Erlotinib Hydrochloride|Participants received a single 150 mg oral dose of erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
187552|NCT01609543|O1|Outcome|Erlotinib Hydrochloride|Participants received a single 150 mg oral dose erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity, or consent withdrawal, whichever occurred first up to 34 months.
187553|NCT01609543|E1|Reported Event|Erlotinib Hydrochloride|Participants received a single 150 mg oral dose of erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
187554|NCT01609478|B4|Baseline|Total|Total of all reporting groups
187555|NCT01609478|B3|Baseline|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187556|NCT01609478|B2|Baseline|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187557|NCT01609478|B1|Baseline|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187558|NCT01609478|P3|Participant Flow|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187559|NCT01609478|P2|Participant Flow|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187560|NCT01609478|P1|Participant Flow|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187561|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187562|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187563|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187564|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187565|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187566|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187567|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187568|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187569|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187570|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187571|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187572|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187573|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187574|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187575|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187576|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187577|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187578|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187579|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187580|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187581|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187582|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187583|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187584|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187585|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187586|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187587|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187588|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187589|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187590|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187591|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187592|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187593|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187594|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187595|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187596|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187597|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187598|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187599|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187600|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187601|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187602|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187603|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187604|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187605|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187606|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187607|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187608|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187609|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187610|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187611|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187612|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187613|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187614|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187615|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187616|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187617|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187618|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187619|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187620|NCT01609478|E3|Reported Event|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187621|NCT01609478|E2|Reported Event|Indacaterol Acetate 150 mcg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187622|NCT01609478|E1|Reported Event|Indacaterol Acetate 75 mcg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
187623|NCT01609348|B3|Baseline|Total|Total of all reporting groups
187624|NCT01609348|B2|Baseline|Sugar Pill|Placebo: Capsule matching active drug to be taken once a day for 12 weeks
187625|NCT01609348|B1|Baseline|Venlafaxine|"225 mg daily over 12 weeks~Venlafaxine: 225 mg daily for 12 weeks"
187626|NCT01609348|P2|Participant Flow|Sugar Pill|Placebo: Capsule matching active drug to be taken once a day for 12 weeks
187627|NCT01609348|P1|Participant Flow|Venlafaxine|"225 mg daily over 12 weeks~Venlafaxine: 225 mg daily for 12 weeks"
187628|NCT01609348|O2|Outcome|Sugar Pill|Placebo: Capsule matching active drug to be taken once a day for 12 weeks
187629|NCT01609348|O1|Outcome|Venlafaxine|"225 mg daily over 12 weeks~Venlafaxine: 225 mg daily for 12 weeks"
187630|NCT01609348|E2|Reported Event|Sugar Pill|Placebo: Capsule matching active drug to be taken once a day for 12 weeks
187631|NCT01609348|E1|Reported Event|Venlafaxine|"225 mg daily over 12 weeks~Venlafaxine: 225 mg daily for 12 weeks"
187632|NCT01609257|B3|Baseline|Total|Total of all reporting groups
187633|NCT01609257|B2|Baseline|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187634|NCT01609257|B1|Baseline|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187635|NCT01609257|P2|Participant Flow|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187636|NCT01609257|P1|Participant Flow|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187637|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187638|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187639|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187640|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187641|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187642|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187643|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187644|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187645|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187646|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187647|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187648|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187649|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187650|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187651|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187652|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187653|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187654|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187655|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187656|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187657|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187658|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187659|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187660|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187661|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187662|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187663|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187664|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187665|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187666|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187667|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187668|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187669|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
188834|NCT01605877|O5|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
187670|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187671|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187672|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187673|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187674|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187675|NCT01609257|O2|Outcome|Placebo_Not Infected|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187676|NCT01609257|O1|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187677|NCT01609257|O2|Outcome|Placebo_Not Ill|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187678|NCT01609257|O1|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187679|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187680|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187681|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187682|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187683|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187684|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187685|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187686|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187687|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187688|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187689|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187690|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187691|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187692|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187693|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187694|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187695|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187696|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187697|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187698|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187699|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187700|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187701|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187702|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187703|NCT01609257|E2|Reported Event|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
187704|NCT01609257|E1|Reported Event|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
187705|NCT01609062|B3|Baseline|Total|Total of all reporting groups
187706|NCT01609062|B2|Baseline|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187707|NCT01609062|B1|Baseline|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187708|NCT01609062|P2|Participant Flow|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187709|NCT01609062|P1|Participant Flow|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187710|NCT01609062|O3|Outcome|All Subjects|Both groups combined
187711|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
188835|NCT01605877|O4|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
187712|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187713|NCT01609062|O3|Outcome|All Subjects|Both groups combined
187714|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187715|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187716|NCT01609062|O3|Outcome|All Subjects|Both groups combined
187717|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187718|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187719|NCT01609062|O3|Outcome|All Subjects|Both groups combined
187720|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187721|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187722|NCT01609062|O3|Outcome|All Subjects|Both groups combined
187723|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187724|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187725|NCT01609062|O3|Outcome|All Subjects|Both groups combined
187726|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187727|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187728|NCT01609062|O3|Outcome|All Subjects|Both groups combined
187729|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187730|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187731|NCT01609062|O3|Outcome|All Subjects|Both groups combined
187732|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187733|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187734|NCT01609062|O3|Outcome|All Subjects|Both groups combined
187735|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187736|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187737|NCT01609062|O3|Outcome|All Subjects|Both groups combined
187738|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187739|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187740|NCT01609062|O3|Outcome|All Subjects|Both groups combined
187741|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187742|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187743|NCT01609062|O3|Outcome|All Subjects|Both groups combined
187744|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187745|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187746|NCT01609062|O3|Outcome|All Subjects|Both groups combined
187747|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187748|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187749|NCT01609062|E2|Reported Event|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187750|NCT01609062|E1|Reported Event|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
187751|NCT01609023|B1|Baseline|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
187752|NCT01609023|P1|Participant Flow|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
187753|NCT01609023|O1|Outcome|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
187754|NCT01609023|O1|Outcome|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
187755|NCT01609023|O1|Outcome|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
187756|NCT01609023|O1|Outcome|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
187757|NCT01609023|O1|Outcome|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
187758|NCT01609023|O1|Outcome|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
187759|NCT01609023|O1|Outcome|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
187760|NCT01609023|E1|Reported Event|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
187761|NCT01609010|B3|Baseline|Total|Total of all reporting groups
187762|NCT01609010|B2|Baseline|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
187763|NCT01609010|B1|Baseline|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
187764|NCT01609010|P2|Participant Flow|Rituximab + Interferon (IFN)|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-alpha2a (IFN-α2a), 3 million international units per day (MIU/day), subcutaneously (SC), during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
187765|NCT01609010|P1|Participant Flow|Rituximab Monotherapy|Participants rituximab received 375 milligrams per square meter (mg/m^2), intravenously (IV), once weekly for 4 weeks. Participants who achieved minor response (MR), partial response (PR), or complete response (CR) after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
187766|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
187767|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
187768|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
187769|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
187770|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
187771|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
187772|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
187773|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
187774|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
187775|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
187776|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
187777|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
187778|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
187779|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
187780|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
187781|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
187782|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
187783|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
187784|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
187785|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
187786|NCT01609010|E2|Reported Event|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
187787|NCT01609010|E1|Reported Event|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
187788|NCT01608971|B3|Baseline|Total|Total of all reporting groups
187789|NCT01608971|B2|Baseline|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
187790|NCT01608971|B1|Baseline|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
187791|NCT01608971|P2|Participant Flow|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
187792|NCT01608971|P1|Participant Flow|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
187793|NCT01608971|O2|Outcome|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
187794|NCT01608971|O1|Outcome|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
187795|NCT01608971|O2|Outcome|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
187796|NCT01608971|O1|Outcome|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
187797|NCT01608971|O2|Outcome|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
187798|NCT01608971|O1|Outcome|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
187799|NCT01608971|O2|Outcome|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
187800|NCT01608971|O1|Outcome|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
187801|NCT01608971|E2|Reported Event|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
187802|NCT01608971|E1|Reported Event|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
187803|NCT01608815|B4|Baseline|Total|Total of all reporting groups
187804|NCT01608815|B3|Baseline|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
187805|NCT01608815|B2|Baseline|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
187806|NCT01608815|B1|Baseline|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
187807|NCT01608815|P3|Participant Flow|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
187808|NCT01608815|P2|Participant Flow|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
187809|NCT01608815|P1|Participant Flow|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
187810|NCT01608815|O3|Outcome|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
187811|NCT01608815|O2|Outcome|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
187812|NCT01608815|O1|Outcome|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
187813|NCT01608815|O3|Outcome|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
187814|NCT01608815|O2|Outcome|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
187815|NCT01608815|O1|Outcome|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
187816|NCT01608815|O3|Outcome|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
187817|NCT01608815|O2|Outcome|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
187818|NCT01608815|O1|Outcome|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
187819|NCT01608815|O3|Outcome|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
187820|NCT01608815|O2|Outcome|Dolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
187821|NCT01608815|O1|Outcome|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
187822|NCT01608815|E3|Reported Event|Children (Group 3)|Participants 2 to 11 years of age received a single dose of Typhoid Vi Polysaccharide Vaccine
187823|NCT01608815|E2|Reported Event|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose of Typhoid Vi Polysaccharide Vaccine
187824|NCT01608815|E1|Reported Event|Adults (Group 1)|Participants ≥18 years of age received a single dose of Typhoid Vi Polysaccharide Vaccine
187825|NCT01608724|B1|Baseline|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
187826|NCT01608724|P1|Participant Flow|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
187827|NCT01608724|O1|Outcome|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
187828|NCT01608724|O1|Outcome|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
187829|NCT01608724|O1|Outcome|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
187830|NCT01608724|O1|Outcome|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
187831|NCT01608724|E1|Reported Event|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
187832|NCT01608672|B1|Baseline|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
187833|NCT01608672|P1|Participant Flow|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
187834|NCT01608672|O1|Outcome|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
187835|NCT01608672|O1|Outcome|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
187836|NCT01608672|O1|Outcome|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
187837|NCT01608672|E1|Reported Event|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
187838|NCT01608659|B1|Baseline|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
187839|NCT01608659|P1|Participant Flow|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
187840|NCT01608659|O1|Outcome|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
187841|NCT01608659|O1|Outcome|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
187842|NCT01608659|O1|Outcome|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
187843|NCT01608659|E1|Reported Event|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
187844|NCT01608490|B3|Baseline|Total|Total of all reporting groups
187845|NCT01608490|B2|Baseline|Control Arm is Standard Medical Care|The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
187846|NCT01608490|B1|Baseline|RePneu Lung Volume Reduction Coil System|"The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.~RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use."
187847|NCT01608490|P2|Participant Flow|Control Arm is Standard Medical Care|The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
187910|NCT01608100|O1|Outcome|Negative Predictive Value in K2 EDTA|Negative Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff 26.2 pg/mL).
188107|NCT01607450|P7|Participant Flow|Type 2 DM GLP-1 High Dose|GLP-1 High Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
187848|NCT01608490|P1|Participant Flow|RePneu Lung Volume Reduction Coil System|"The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.~RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use."
187849|NCT01608490|O2|Outcome|Control Arm is Standard Medical Care|The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
187850|NCT01608490|O1|Outcome|RePneu Lung Volume Reduction Coil System|"The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.~RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use."
187851|NCT01608490|O2|Outcome|Control Arm is Standard Medical Care|The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
187852|NCT01608490|O1|Outcome|RePneu Lung Volume Reduction Coil System|"The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.~RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use."
187853|NCT01608490|E2|Reported Event|Control Arm is Standard Medical Care|The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
187854|NCT01608490|E1|Reported Event|RePneu Lung Volume Reduction Coil System|"The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.~RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use."
187855|NCT01608321|B3|Baseline|Total|Total of all reporting groups
187856|NCT01608321|B2|Baseline|Sham rTMS|"Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.~Sham device: Placebo Device that simulates active rTMS treatment"
187857|NCT01608321|B1|Baseline|rTMS|"Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
187858|NCT01608321|P2|Participant Flow|Sham rTMS|"Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.~Sham device: Placebo Device that simulates active rTMS treatment"
187859|NCT01608321|P1|Participant Flow|rTMS|"Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
187860|NCT01608321|O2|Outcome|Sham rTMS|"Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.~Sham device: Placebo Device that simulates active rTMS treatment"
187861|NCT01608321|O1|Outcome|rTMS|"Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
187862|NCT01608321|E2|Reported Event|Sham rTMS|"Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.~Sham device: Placebo Device that simulates active rTMS treatment"
187863|NCT01608321|E1|Reported Event|rTMS|"Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
187864|NCT01608308|B3|Baseline|Total|Total of all reporting groups
187865|NCT01608308|B2|Baseline|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
187866|NCT01608308|B1|Baseline|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
187867|NCT01608308|P2|Participant Flow|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with acetyl-para-aminophenol (APAP, also known as acetaminophen) concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
194319|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
187868|NCT01608308|P1|Participant Flow|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with acetyl-para-aminophenol (APAP, also known as acetaminophen) concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
187869|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
187870|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
187871|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
187872|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
187873|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
187874|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
187875|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
187876|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
187877|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
187878|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
187879|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
187880|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
187911|NCT01608100|O3|Outcome|Specificity in Serum Separator|Specificity for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall (99th percentile cutoff 26.2 pg/mL).
188836|NCT01605877|O3|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
187881|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
187882|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
187883|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
187884|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
187885|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
187886|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
187887|NCT01608308|E2|Reported Event|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
187888|NCT01608308|E1|Reported Event|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
187889|NCT01608295|B3|Baseline|Total|Total of all reporting groups
187890|NCT01608295|B2|Baseline|Paroxetine; Paxil|"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.~Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly will have incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs will be adjusted according to individual tolerability and safety."
187891|NCT01608295|B1|Baseline|Vilazodone; Viibryd|"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.~Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly will have incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety."
187892|NCT01608295|P2|Participant Flow|Paroxetine; Paxil|"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.~Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly will have incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs will be adjusted according to individual tolerability and safety."
187912|NCT01608100|O2|Outcome|Specificity in Lithium Heparin Separator|Specificity for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall (99th percentile cutoff 26.2 pg/mL).
188108|NCT01607450|P6|Participant Flow|Lean GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
187893|NCT01608295|P1|Participant Flow|Vilazodone; Viibryd|"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.~Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly will have incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety."
187894|NCT01608295|O1|Outcome|Vilazodone and Paroxetine|Subjects randomized to receive vilazodone relative to subjects randomized to receive paroxetine.
187895|NCT01608295|O2|Outcome|Paroxetine; Paxil|"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.~Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly will have incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs will be adjusted according to individual tolerability and safety."
187896|NCT01608295|O1|Outcome|Vilazodone; Viibryd|"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.~Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly will have incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety."
187897|NCT01608295|O2|Outcome|Paroxetine; Paxil|Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly received incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs were adjusted according to individual tolerability and safety.
187898|NCT01608295|O1|Outcome|Vilazodone; Viibryd|Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly received incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety.
187899|NCT01608295|O2|Outcome|Paroxetine; Paxil|Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly received incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs were adjusted according to individual tolerability and safety.
187900|NCT01608295|O1|Outcome|Vilazodone; Viibryd|Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly received incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety.
187901|NCT01608295|E2|Reported Event|Paroxetine; Paxil|Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly received incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs were adjusted according to individual tolerability and safety.
187902|NCT01608295|E1|Reported Event|Vilazodone; Viibryd|Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly received incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety.
187903|NCT01608100|B1|Baseline|ARCHITECT STAT High Sensitive Troponin I Assay Testing|All subjects will have their blood tested by the investigational ARCHITECT STAT High Sensitive Troponin I assay. Specimens were collected at 11 emergency departments from 1,101 subjects presenting to the emergency department with symptoms consistent with acute coronary syndrome (ACS). All subject diagnoses were adjudicated by three board certified cardiologists according to current standard of care.
187904|NCT01608100|P1|Participant Flow|ARCHITECT STAT High Sensitive Troponin I Assay Testing|"All subjects will have their blood tested by the investigational Troponin I assay.~ARCHITECT STAT High Sensitive Troponin I Assay: Test blood samples from the ARCHITECT STAT High Sensitive Troponin I Assay.~Results obtained will be used to assess the prognosis of subjects for risk of ACM/MACE in the time frames (30 days and 90 days) after the Emergency Department visit.~Troponin results will be compared to documented ACM/MACE events at the 30 day and 90 day time points after Emergency Department visit."
187905|NCT01608100|O3|Outcome|Positive Predictive Value in Serum Separator|Positive Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
187906|NCT01608100|O2|Outcome|Positive Predictive Value in Lithium Heparin Separator|Positive Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
187907|NCT01608100|O1|Outcome|Positive Predictive Value in K2 EDTA|Positive Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
187908|NCT01608100|O3|Outcome|Negative Predictive Value in Serum Separator|Negative Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff 26.2 pg/mL).
187909|NCT01608100|O2|Outcome|Negative Predictive Value in Lithium Heparin Separator|Negative Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff 26.2 pg/mL).
194320|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
187913|NCT01608100|O1|Outcome|Specificity in K2 EDTA|Specificity for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall (99th percentile cutoff 26.2 pg/mL).
187914|NCT01608100|O3|Outcome|Sensitivity in Serum Separator|Sensitivity for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
187915|NCT01608100|O2|Outcome|Sensitivity in Lithium Heparin Separator|Sensitivity for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall (99th percentile cutoff 26.2 pg/mL).
187916|NCT01608100|O1|Outcome|Sensitivity in K2 EDTA|Sensitivity for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
187917|NCT01608100|O6|Outcome|90-day Prognosis for Serum Separator Tube Type|The 90-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
187918|NCT01608100|O5|Outcome|30-day Prognosis for Serum Separator Tube Type|The 30-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
187919|NCT01608100|O4|Outcome|90-day Prognosis for Lithium Heparin Separator Tube Type|The 90-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
187920|NCT01608100|O3|Outcome|30-day Prognosis for Lithium Heparin Separator Tube Type|The 30-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
187921|NCT01608100|O2|Outcome|90-day Prognosis for K2 EDTA Tube Type|The 90-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
187922|NCT01608100|O1|Outcome|30-day Prognosis for K2 EDTA Tube Type|The 30-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
187923|NCT01608100|O3|Outcome|Area Under the Curve in Serum Separator|Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
187924|NCT01608100|O2|Outcome|Area Under the Curve in Lithium Heparin Separator|Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
187925|NCT01608100|O1|Outcome|Area Under the Curve in K2 EDTA|Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
187926|NCT01608100|E1|Reported Event|ARCHITECT STAT High Sensitive Troponin I Assay Testing|"All subjects will have their blood tested by the investigational Troponin I assay.~ARCHITECT STAT High Sensitive Troponin I Assay: Test blood samples from the ARCHITECT STAT High Sensitive Troponin I Assay.~Results obtained will be used to assess the prognosis of subjects with a troponin result for risk of ACM/MACE in the time frames (30 days and 90 days) after the Emergency Department visit.~Troponin results will be compared to documented ACM/MACE events at the 30 day and 90 day time points after Emergency Department visit."
187927|NCT01607853|B1|Baseline|Daivobet® Gel|"Each of the 24 subjects participating in this exploratory trial received:~Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187928|NCT01607853|P1|Participant Flow|Daivobet® Gel|"Each of the 24 subjects participating in this exploratory trial received:~Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187929|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187930|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187931|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187932|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187933|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187934|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187935|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188109|NCT01607450|P5|Participant Flow|Type 2 DM GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
187936|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187937|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187938|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187939|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187940|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187941|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187942|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187943|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187944|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187945|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187946|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187947|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187948|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187949|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187950|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187951|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187952|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187953|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187954|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187955|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187956|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187957|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187958|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187959|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188057|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
187960|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187961|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187962|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187963|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187964|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187965|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187966|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187967|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187968|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187969|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187970|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187971|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187972|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187973|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187974|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187975|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187976|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187977|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187978|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187979|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187980|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187981|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187982|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187983|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188104|NCT01607450|B3|Baseline|Type 2 DM GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
188837|NCT01605877|O2|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
187984|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187985|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187986|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187987|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187988|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187989|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187990|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187991|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187992|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187993|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187994|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187995|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187996|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187997|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187998|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
187999|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188000|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188001|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188002|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188003|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188004|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188005|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188006|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188007|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188105|NCT01607450|B2|Baseline|Lean GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
188838|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188008|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188009|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188010|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188011|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188012|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188013|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188014|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188015|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188016|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188017|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188018|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188019|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188020|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188021|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188022|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188023|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188024|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188025|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188026|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188027|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188028|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188029|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188030|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188031|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188106|NCT01607450|B1|Baseline|Lean Saline|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
194321|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
188032|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188033|NCT01607853|E1|Reported Event|Daivobet® Gel|"Each of the 24 subjects participating in this exploratory trial received:~Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
188034|NCT01607645|B3|Baseline|Total|Total of all reporting groups
188035|NCT01607645|B2|Baseline|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188036|NCT01607645|B1|Baseline|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188037|NCT01607645|P2|Participant Flow|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188038|NCT01607645|P1|Participant Flow|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188039|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188040|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188041|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188042|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188043|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188044|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188045|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188046|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188047|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188048|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188049|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188050|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188051|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188052|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188053|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188054|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188055|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188056|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188058|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188059|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188060|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188061|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188062|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188063|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188064|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188065|NCT01607645|E2|Reported Event|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188066|NCT01607645|E1|Reported Event|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
188067|NCT01607593|B1|Baseline|SERTRALINE|Participants with PTSD who were treated with sertraline as instructed by physicians.
188068|NCT01607593|P1|Participant Flow|SERTRALINE|Participants with post-traumatic stress disorder (PTSD) who were treated with sertraline as instructed by physicians
188069|NCT01607593|O1|Outcome|Sertraline (Zoloft)|Participants with PTSD who were treated with sertraline as instructed by physicians
188070|NCT01607593|O1|Outcome|Sertraline (Zoloft)|Participants with PTSD who were treated with sertraline as instructed by physicians
188071|NCT01607593|O1|Outcome|Sertraline (Zoloft)|Participants with PTSD who were treated with sertraline as instructed by physicians
188072|NCT01607593|E1|Reported Event|SERTRALINE|Participants with PTSD who were treated with sertraline as instructed by physicians
188073|NCT01607554|B1|Baseline|Irinotecan|"The starting dose of irinotecan for the study is 180 mg/m2, given intravenously every 14 days. Each 14 day period will constitute one cycle of treatment.~Irinotecan: 180 mg/m2 Irinotecan intravenously over 60 minutes on day 1 of each cycle~Pre-medication for irinotecan: palonosetron 0.25 mg and dexamethasone 8 – 16 mg, both administered intravenously. Atropine 0.25 – 0.5 mg subcutaneously or IV is at the discretion of the treating physician"
188074|NCT01607554|P1|Participant Flow|Irinotecan|"The starting dose of irinotecan for the study is 180 mg/m2, given intravenously every 14 days. Each 14 day period will constitute one cycle of treatment.~Irinotecan: 180 mg/m2 Irinotecan intravenously over 60 minutes on day 1 of each cycle~Pre-medication for irinotecan: palonosetron 0.25 mg and dexamethasone 8 – 16 mg, both administered intravenously. Atropine 0.25 – 0.5 mg subcutaneously or IV is at the discretion of the treating physician"
188075|NCT01607554|O1|Outcome|Irinotecan|"The starting dose of irinotecan for the study is 180 mg/m2, given intravenously every 14 days. Each 14 day period will constitute one cycle of treatment.~Irinotecan: 180 mg/m2 Irinotecan intravenously over 60 minutes on day 1 of each cycle~Pre-medication for irinotecan: palonosetron 0.25 mg and dexamethasone 8 – 16 mg, both administered intravenously. Atropine 0.25 – 0.5 mg subcutaneously or IV is at the discretion of the treating physician"
188076|NCT01607554|O1|Outcome|Irinotecan|"The starting dose of irinotecan for the study is 180 mg/m2, given intravenously every 14 days. Each 14 day period will constitute one cycle of treatment.~Irinotecan: 180 mg/m2 Irinotecan intravenously over 60 minutes on day 1 of each cycle~Pre-medication for irinotecan: palonosetron 0.25 mg and dexamethasone 8 – 16 mg, both administered intravenously. Atropine 0.25 – 0.5 mg subcutaneously or IV is at the discretion of the treating physician"
188077|NCT01607554|O1|Outcome|Irinotecan|"The starting dose of irinotecan for the study is 180 mg/m2, given intravenously every 14 days. Each 14 day period will constitute one cycle of treatment.~Irinotecan: 180 mg/m2 Irinotecan intravenously over 60 minutes on day 1 of each cycle~Pre-medication for irinotecan: palonosetron 0.25 mg and dexamethasone 8 – 16 mg, both administered intravenously. Atropine 0.25 – 0.5 mg subcutaneously or IV is at the discretion of the treating physician"
188078|NCT01607554|O1|Outcome|Irinotecan|"The starting dose of irinotecan for the study is 180 mg/m2, given intravenously every 14 days. Each 14 day period will constitute one cycle of treatment.~Irinotecan: 180 mg/m2 Irinotecan intravenously over 60 minutes on day 1 of each cycle~Pre-medication for irinotecan: palonosetron 0.25 mg and dexamethasone 8 – 16 mg, both administered intravenously. Atropine 0.25 – 0.5 mg subcutaneously or IV is at the discretion of the treating physician"
188079|NCT01607554|O1|Outcome|Irinotecan|"The starting dose of irinotecan for the study is 180 mg/m2, given intravenously every 14 days. Each 14 day period will constitute one cycle of treatment.~Irinotecan: 180 mg/m2 Irinotecan intravenously over 60 minutes on day 1 of each cycle~Pre-medication for irinotecan: palonosetron 0.25 mg and dexamethasone 8 – 16 mg, both administered intravenously. Atropine 0.25 – 0.5 mg subcutaneously or IV is at the discretion of the treating physician"
188080|NCT01607554|O1|Outcome|Irinotecan|"The starting dose of irinotecan for the study is 180 mg/m2, given intravenously every 14 days. Each 14 day period will constitute one cycle of treatment.~Irinotecan: 180 mg/m2 Irinotecan intravenously over 60 minutes on day 1 of each cycle~Pre-medication for irinotecan: palonosetron 0.25 mg and dexamethasone 8 – 16 mg, both administered intravenously. Atropine 0.25 – 0.5 mg subcutaneously or IV is at the discretion of the treating physician"
188081|NCT01607554|O1|Outcome|Irinotecan|"The starting dose of irinotecan for the study is 180 mg/m2, given intravenously every 14 days. Each 14 day period will constitute one cycle of treatment.~Irinotecan: 180 mg/m2 Irinotecan intravenously over 60 minutes on day 1 of each cycle~Pre-medication for irinotecan: palonosetron 0.25 mg and dexamethasone 8 – 16 mg, both administered intravenously. Atropine 0.25 – 0.5 mg subcutaneously or IV is at the discretion of the treating physician"
188082|NCT01607554|E1|Reported Event|Irinotecan|"The starting dose of irinotecan for the study is 180 mg/m2, given intravenously every 14 days. Each 14 day period will constitute one cycle of treatment.~Irinotecan: 180 mg/m2 Irinotecan intravenously over 60 minutes on day 1 of each cycle~Pre-medication for irinotecan: palonosetron 0.25 mg and dexamethasone 8 – 16 mg, both administered intravenously. Atropine 0.25 – 0.5 mg subcutaneously or IV is at the discretion of the treating physician"
188083|NCT01607476|B4|Baseline|Total|Total of all reporting groups
188084|NCT01607476|B3|Baseline|Cognitive Normal Young|"Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
188085|NCT01607476|B2|Baseline|Cognitive Normal Elderly|"Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
188086|NCT01607476|B1|Baseline|Alzheimer's Disease|"Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR).~Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
188087|NCT01607476|P3|Participant Flow|Cognitive Normal Young|"Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
188088|NCT01607476|P2|Participant Flow|Cognitive Normal Elderly|"Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
188089|NCT01607476|P1|Participant Flow|Alzheimer's Disease|"Subjects who have the clinical diagnosis of probable Alzheimer's disease (AD) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR). Interventions include C11 Pittsburgh Compound B (PiB) PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 millicurie (mCi) C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
188090|NCT01607476|O3|Outcome|Cognitive Normal Young|"Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
188091|NCT01607476|O2|Outcome|Cognitive Normal Elderly|"Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
188092|NCT01607476|O1|Outcome|Alzheimer's Disease|"Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR).~Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
188093|NCT01607476|O3|Outcome|Cognitive Normal Young|"Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
188094|NCT01607476|O2|Outcome|Cognitive Normal Elderly|"Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
188095|NCT01607476|O1|Outcome|Alzheimer's Disease|"Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR).~Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
188096|NCT01607476|E3|Reported Event|Cognitive Normal Young|"Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
188097|NCT01607476|E2|Reported Event|Cognitive Normal Elderly|"Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
188098|NCT01607476|E1|Reported Event|Alzheimer's Disease|"Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR).~Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
188099|NCT01607450|B8|Baseline|Total|Total of all reporting groups
188100|NCT01607450|B7|Baseline|Type 2 DM GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
188101|NCT01607450|B6|Baseline|Lean GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
188102|NCT01607450|B5|Baseline|Type 2 DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
188103|NCT01607450|B4|Baseline|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
188839|NCT01605877|O2|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188110|NCT01607450|P4|Participant Flow|Lean GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
188111|NCT01607450|P3|Participant Flow|Type 2 DM GLP-1 Mid-Range Dose|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
188112|NCT01607450|P2|Participant Flow|Lean GLP-1 Mid-Range Dose|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
188113|NCT01607450|P1|Participant Flow|Lean Placebo|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
188114|NCT01607450|O7|Outcome|Type 2 DM GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
188115|NCT01607450|O6|Outcome|Lean GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
188116|NCT01607450|O5|Outcome|Type 2 DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
188117|NCT01607450|O4|Outcome|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
188118|NCT01607450|O3|Outcome|Type 2 DM GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
188119|NCT01607450|O2|Outcome|Lean GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
188120|NCT01607450|O1|Outcome|Lean Saline|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
188121|NCT01607450|O7|Outcome|Type 2 DM GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
188122|NCT01607450|O6|Outcome|Lean GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
188123|NCT01607450|O5|Outcome|Type 2 DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
188124|NCT01607450|O4|Outcome|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
188125|NCT01607450|O3|Outcome|Type 2 DM GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
188126|NCT01607450|O2|Outcome|Lean GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
188127|NCT01607450|O1|Outcome|Lean Saline|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
188128|NCT01607450|O7|Outcome|Type 2 DM GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
188129|NCT01607450|O6|Outcome|Lean GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
188130|NCT01607450|O5|Outcome|Type 2DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
188131|NCT01607450|O4|Outcome|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
188132|NCT01607450|O3|Outcome|Type 2 DM GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
188133|NCT01607450|O2|Outcome|Lean GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
188134|NCT01607450|O1|Outcome|Lean Saline|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
188135|NCT01607450|O7|Outcome|Type 2 DM GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
188136|NCT01607450|O6|Outcome|Lean GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
188137|NCT01607450|O5|Outcome|Type 2DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
188138|NCT01607450|O4|Outcome|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
188139|NCT01607450|O3|Outcome|Type 2 DM GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
188140|NCT01607450|O2|Outcome|Lean GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
188141|NCT01607450|O1|Outcome|Lean Saline|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
188142|NCT01607450|O7|Outcome|Type 2 DM GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
188143|NCT01607450|O6|Outcome|Lean GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
188144|NCT01607450|O5|Outcome|Type 2DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
188145|NCT01607450|O4|Outcome|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
188146|NCT01607450|O3|Outcome|Type 2 DM GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
188147|NCT01607450|O2|Outcome|Lean GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
188148|NCT01607450|O1|Outcome|Lean Saline|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
188149|NCT01607450|E7|Reported Event|Type 2 DM GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
188150|NCT01607450|E6|Reported Event|Lean GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
188151|NCT01607450|E5|Reported Event|Type 2 DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
188152|NCT01607450|E4|Reported Event|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
188153|NCT01607450|E3|Reported Event|Type 2 DM GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
188154|NCT01607450|E2|Reported Event|Lean GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
188155|NCT01607450|E1|Reported Event|Lean Saline|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
188156|NCT01607411|B1|Baseline|Overall|All randomized participants who received atleast one dose of the study treatments
188157|NCT01607411|P4|Participant Flow|Placebo Toothpaste (0 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
188249|NCT01607203|B2|Baseline|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
188158|NCT01607411|P3|Participant Flow|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
188159|NCT01607411|P2|Participant Flow|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
188160|NCT01607411|P1|Participant Flow|Sodium Fluoride(NaF) Toothpaste (1426parts Per Million(Ppm) F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 grams (g) ± 0.1g of NaF toothpaste(1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
188161|NCT01607411|O4|Outcome|Placebo Toothpaste (0 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
188162|NCT01607411|O3|Outcome|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
188163|NCT01607411|O2|Outcome|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
188164|NCT01607411|O1|Outcome|NaF Toothpaste (1426 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
188165|NCT01607411|O4|Outcome|Placebo Toothpaste (0 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
188166|NCT01607411|O3|Outcome|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
188167|NCT01607411|O2|Outcome|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
188168|NCT01607411|O1|Outcome|NaF Toothpaste (1426 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
188169|NCT01607411|O3|Outcome|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
188170|NCT01607411|O2|Outcome|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
188171|NCT01607411|O1|Outcome|NaF Toothpaste (1426 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
188172|NCT01607411|O4|Outcome|Placebo Toothpaste (0 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
188173|NCT01607411|O3|Outcome|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
188174|NCT01607411|O2|Outcome|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
188175|NCT01607411|O1|Outcome|NaF Toothpaste (1426 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
188176|NCT01607411|E4|Reported Event|Placebo Toothpaste (0 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
188177|NCT01607411|E3|Reported Event|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
188178|NCT01607411|E2|Reported Event|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
188179|NCT01607411|E1|Reported Event|NaF Toothpaste (1426 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
188180|NCT01607398|B3|Baseline|Total|Total of all reporting groups
188181|NCT01607398|B2|Baseline|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188182|NCT01607398|B1|Baseline|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188183|NCT01607398|P2|Participant Flow|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188184|NCT01607398|P1|Participant Flow|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188185|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188186|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188187|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188188|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188189|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188190|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188191|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188192|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188193|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188194|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188195|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188196|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188197|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188198|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188199|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188200|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188201|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188250|NCT01607203|B1|Baseline|HCG TRIGGERING|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
188202|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188203|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188204|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188205|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188206|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188207|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188208|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188209|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188210|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188211|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188212|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188213|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188214|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188215|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188216|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188217|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188218|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188219|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188220|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188221|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188222|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188223|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188224|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188225|NCT01607398|E2|Reported Event|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188404|NCT01606319|P2|Participant Flow|Ibuprofen|"ibuprofen given as needed for pain or fever~Ibuprofen: 9.4 mg/kg every 6 hours as needed"
188226|NCT01607398|E1|Reported Event|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
188227|NCT01607346|B1|Baseline|Ezogabine/Retigabine|Participants received ezogabine/retigabine tablets orally in three equally divided doses each day with or without food. The starting dose of ezogabine/retigabine was 300 milligrams (mg)/day. Participants were to be up titrated by 150 mg/day weekly up to a minimum ezogabine/retigabine daily dose of 600 mg/day and a maximum ezogabine/retigabine daily dose of 1200 mg/day. If participants missed one dose or more, it was recommended that they took a single dose as soon as they remember. After taking a missed dose, at least 3 hours were to elapse before the next dose and then the normal dosing schedule was to be resumed. After Day 22 of treatment, if a participant was unable to tolerate doses of ezogabine/retigabine greater than 600 mg/day, the investigator was able to decrease the dose as appropriate.
188228|NCT01607346|P1|Participant Flow|Ezogabine/Retigabine|Participants received ezogabine/retigabine tablets orally in three equally divided doses each day with or without food. The starting dose of ezogabine/retigabine was 300 milligrams (mg)/day. Participants were to be up titrated by 150 mg/day weekly up to a minimum ezogabine/retigabine daily dose of 600 mg/day and a maximum ezogabine/retigabine daily dose of 1200 mg/day. If participants missed one dose or more, it was recommended that they took a single dose as soon as they remember. After taking a missed dose, at least 3 hours were to elapse before the next dose and then the normal dosing schedule was to be resumed. After Day 22 of treatment, if a participant was unable to tolerate doses of ezogabine/retigabine greater than 600 mg/day, the investigator was able to decrease the dose as appropriate.
188229|NCT01607346|O1|Outcome|Ezogabine/Retigabine|Participants received ezogabine/retigabine tablets orally in three equally divided doses each day with or without food. The starting dose of ezogabine/retigabine was 300 milligrams (mg)/day. Participants were to be up titrated by 150 mg/day weekly up to a minimum ezogabine/retigabine daily dose of 600 mg/day and a maximum ezogabine/retigabine daily dose of 1200 mg/day. If participants missed one dose or more, it was recommended that they took a single dose as soon as they remember. After taking a missed dose, at least 3 hours were to elapse before the next dose and then the normal dosing schedule was to be resumed. After Day 22 of treatment, if a participant was unable to tolerate doses of ezogabine/retigabine greater than 600 mg/day, the investigator was able to decrease the dose as appropriate.
188230|NCT01607346|O1|Outcome|Ezogabine/Retigabine|Participants received ezogabine/retigabine tablets orally in three equally divided doses each day with or without food. The starting dose of ezogabine/retigabine was 300 milligrams (mg)/day. Participants were to be up titrated by 150 mg/day weekly up to a minimum ezogabine/retigabine daily dose of 600 mg/day and a maximum ezogabine/retigabine daily dose of 1200 mg/day. If participants missed one dose or more, it was recommended that they took a single dose as soon as they remember. After taking a missed dose, at least 3 hours were to elapse before the next dose and then the normal dosing schedule was to be resumed. After Day 22 of treatment, if a participant was unable to tolerate doses of ezogabine/retigabine greater than 600 mg/day, the investigator was able to decrease the dose as appropriate.
188231|NCT01607346|O1|Outcome|Ezogabine/Retigabine|Participants received ezogabine/retigabine tablets orally in three equally divided doses each day with or without food. The starting dose of ezogabine/retigabine was 300 milligrams (mg)/day. Participants were to be up titrated by 150 mg/day weekly up to a minimum ezogabine/retigabine daily dose of 600 mg/day and a maximum ezogabine/retigabine daily dose of 1200 mg/day. If participants missed one dose or more, it was recommended that they took a single dose as soon as they remember. After taking a missed dose, at least 3 hours were to elapse before the next dose and then the normal dosing schedule was to be resumed. After Day 22 of treatment, if a participant was unable to tolerate doses of ezogabine/retigabine greater than 600 mg/day, the investigator was able to decrease the dose as appropriate.
188232|NCT01607346|O1|Outcome|Ezogabine/Retigabine|Participants received ezogabine/retigabine tablets orally in three equally divided doses each day with or without food. The starting dose of ezogabine/retigabine was 300 milligrams (mg)/day. Participants were to be up titrated by 150 mg/day weekly up to a minimum ezogabine/retigabine daily dose of 600 mg/day and a maximum ezogabine/retigabine daily dose of 1200 mg/day. If participants missed one dose or more, it was recommended that they took a single dose as soon as they remember. After taking a missed dose, at least 3 hours were to elapse before the next dose and then the normal dosing schedule was to be resumed. After Day 22 of treatment, if a participant was unable to tolerate doses of ezogabine/retigabine greater than 600 mg/day, the investigator was able to decrease the dose as appropriate.
188233|NCT01607346|O1|Outcome|Ezogabine/Retigabine|Participants received ezogabine/retigabine tablets orally in three equally divided doses each day with or without food. The starting dose of ezogabine/retigabine was 300 milligrams (mg)/day. Participants were to be up titrated by 150 mg/day weekly up to a minimum ezogabine/retigabine daily dose of 600 mg/day and a maximum ezogabine/retigabine daily dose of 1200 mg/day. If participants missed one dose or more, it was recommended that they took a single dose as soon as they remember. After taking a missed dose, at least 3 hours were to elapse before the next dose and then the normal dosing schedule was to be resumed. After Day 22 of treatment, if a participant was unable to tolerate doses of ezogabine/retigabine greater than 600 mg/day, the investigator was able to decrease the dose as appropriate.
188234|NCT01607346|O1|Outcome|Ezogabine/Retigabine|Participants received ezogabine/retigabine tablets orally in three equally divided doses each day with or without food. The starting dose of ezogabine/retigabine was 300 milligrams (mg)/day. Participants were to be up titrated by 150 mg/day weekly up to a minimum ezogabine/retigabine daily dose of 600 mg/day and a maximum ezogabine/retigabine daily dose of 1200 mg/day. If participants missed one dose or more, it was recommended that they took a single dose as soon as they remember. After taking a missed dose, at least 3 hours were to elapse before the next dose and then the normal dosing schedule was to be resumed. After Day 22 of treatment, if a participant was unable to tolerate doses of ezogabine/retigabine greater than 600 mg/day, the investigator was able to decrease the dose as appropriate.
188245|NCT01607320|P1|Participant Flow|Raloxifene|"3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7~Raloxifene: Thirty PCOS patients treated with 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 following an initial provera withdrawal"
188246|NCT01607320|O1|Outcome|All Study Participants|The study was randomized between the two treatments and was never unblinded, threfore randomization is unknown.
188247|NCT01607320|E1|Reported Event|All Study Participants|The study was randomized between the two treatments and was never unblinded, threfore randomization is unknown.
188235|NCT01607346|O1|Outcome|Ezogabine/Retigabine|Participants received ezogabine/retigabine tablets orally in three equally divided doses each day with or without food. The starting dose of ezogabine/retigabine was 300 milligrams (mg)/day. Participants were to be up titrated by 150 mg/day weekly up to a minimum ezogabine/retigabine daily dose of 600 mg/day and a maximum ezogabine/retigabine daily dose of 1200 mg/day. If participants missed one dose or more, it was recommended that they took a single dose as soon as they remember. After taking a missed dose, at least 3 hours were to elapse before the next dose and then the normal dosing schedule was to be resumed. After Day 22 of treatment, if a participant was unable to tolerate doses of ezogabine/retigabine greater than 600 mg/day, the investigator was able to decrease the dose as appropriate.
188236|NCT01607346|O1|Outcome|Ezogabine/Retigabine|Participants received ezogabine/retigabine tablets orally in three equally divided doses each day with or without food. The starting dose of ezogabine/retigabine was 300 milligrams (mg)/day. Participants were to be up titrated by 150 mg/day weekly up to a minimum ezogabine/retigabine daily dose of 600 mg/day and a maximum ezogabine/retigabine daily dose of 1200 mg/day. If participants missed one dose or more, it was recommended that they took a single dose as soon as they remember. After taking a missed dose, at least 3 hours were to elapse before the next dose and then the normal dosing schedule was to be resumed. After Day 22 of treatment, if a participant was unable to tolerate doses of ezogabine/retigabine greater than 600 mg/day, the investigator was able to decrease the dose as appropriate.
188237|NCT01607346|O1|Outcome|Ezogabine/Retigabine|Participants received ezogabine/retigabine tablets orally in three equally divided doses each day with or without food. The starting dose of ezogabine/retigabine was 300 milligrams (mg)/day. Participants were to be up titrated by 150 mg/day weekly up to a minimum ezogabine/retigabine daily dose of 600 mg/day and a maximum ezogabine/retigabine daily dose of 1200 mg/day. If participants missed one dose or more, it was recommended that they took a single dose as soon as they remember. After taking a missed dose, at least 3 hours were to elapse before the next dose and then the normal dosing schedule was to be resumed. After Day 22 of treatment, if a participant was unable to tolerate doses of ezogabine/retigabine greater than 600 mg/day, the investigator was able to decrease the dose as appropriate.
188238|NCT01607346|O1|Outcome|Ezogabine/Retigabine|Participants received ezogabine/retigabine tablets orally in three equally divided doses each day with or without food. The starting dose of ezogabine/retigabine was 300 milligrams (mg)/day. Participants were to be up titrated by 150 mg/day weekly up to a minimum ezogabine/retigabine daily dose of 600 mg/day and a maximum ezogabine/retigabine daily dose of 1200 mg/day. If participants missed one dose or more, it was recommended that they took a single dose as soon as they remember. After taking a missed dose, at least 3 hours were to elapse before the next dose and then the normal dosing schedule was to be resumed. After Day 22 of treatment, if a participant was unable to tolerate doses of ezogabine/retigabine greater than 600 mg/day, the investigator was able to decrease the dose as appropriate.
188239|NCT01607346|O1|Outcome|Ezogabine/Retigabine|Participants received ezogabine/retigabine tablets orally in three equally divided doses each day with or without food. The starting dose of ezogabine/retigabine was 300 milligrams (mg)/day. Participants were to be up titrated by 150 mg/day weekly up to a minimum ezogabine/retigabine daily dose of 600 mg/day and a maximum ezogabine/retigabine daily dose of 1200 mg/day. If participants missed one dose or more, it was recommended that they took a single dose as soon as they remember. After taking a missed dose, at least 3 hours were to elapse before the next dose and then the normal dosing schedule was to be resumed. After Day 22 of treatment, if a participant was unable to tolerate doses of ezogabine/retigabine greater than 600 mg/day, the investigator was able to decrease the dose as appropriate.
188240|NCT01607346|O1|Outcome|Ezogabine/Retigabine|Participants received ezogabine/retigabine tablets orally in three equally divided doses each day with or without food. The starting dose of ezogabine/retigabine was 300 milligrams (mg)/day. Participants were to be up titrated by 150 mg/day weekly up to a minimum ezogabine/retigabine daily dose of 600 mg/day and a maximum ezogabine/retigabine daily dose of 1200 mg/day. If participants missed one dose or more, it was recommended that they took a single dose as soon as they remember. After taking a missed dose, at least 3 hours were to elapse before the next dose and then the normal dosing schedule was to be resumed. After Day 22 of treatment, if a participant was unable to tolerate doses of ezogabine/retigabine greater than 600 mg/day, the investigator was able to decrease the dose as appropriate.
188241|NCT01607346|O1|Outcome|Ezogabine/Retigabine|Participants received ezogabine/retigabine tablets orally in three equally divided doses each day with or without food. The starting dose of ezogabine/retigabine was 300 milligrams (mg)/day. Participants were to be up titrated by 150 mg/day weekly up to a minimum ezogabine/retigabine daily dose of 600 mg/day and a maximum ezogabine/retigabine daily dose of 1200 mg/day. If participants missed one dose or more, it was recommended that they took a single dose as soon as they remember. After taking a missed dose, at least 3 hours were to elapse before the next dose and then the normal dosing schedule was to be resumed. After Day 22 of treatment, if a participant was unable to tolerate doses of ezogabine/retigabine greater than 600 mg/day, the investigator was able to decrease the dose as appropriate.
188242|NCT01607346|E1|Reported Event|Ezogabine/Retigabine|Participants received ezogabine/retigabine tablets orally in three equally divided doses each day with or without food. The starting dose of ezogabine/retigabine was 300 milligrams (mg)/day. Participants were to be up titrated by 150 mg/day weekly up to a minimum ezogabine/retigabine daily dose of 600 mg/day and a maximum ezogabine/retigabine daily dose of 1200 mg/day. If participants missed one dose or more, it was recommended that they took a single dose as soon as they remember. After taking a missed dose, at least 3 hours were to elapse before the next dose and then the normal dosing schedule was to be resumed. After Day 22 of treatment, if a participant was unable to tolerate doses of ezogabine/retigabine greater than 600 mg/day, the investigator was able to decrease the dose as appropriate.
188243|NCT01607320|B1|Baseline|All Study Participants|Participants were randomized to receive one of the two following interventions, but the study was terminated and data will not be unblinded: 1) 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 with Raloxifene: Thirty PCOS patients treated with 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 following an initial provera withdrawal; or 2) 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 with Clomiphene: Thirty PCOS patients treated with 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 following an initial provera withdrawal
188244|NCT01607320|P2|Participant Flow|Clomiphene|"3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7~Clomiphene: Thirty PCOS patients treated with 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 following an initial provera withdrawal"
188251|NCT01607203|P2|Participant Flow|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
188252|NCT01607203|P1|Participant Flow|hCG Triggering|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
188253|NCT01607203|O2|Outcome|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
188254|NCT01607203|O1|Outcome|hCG Triggering|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
188255|NCT01607203|O2|Outcome|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
188256|NCT01607203|O1|Outcome|hCG Triggering|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
188257|NCT01607203|O2|Outcome|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
188258|NCT01607203|O1|Outcome|hCG TRIGGERING|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
188259|NCT01607203|E2|Reported Event|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
188260|NCT01607203|E1|Reported Event|hCG TRIGGERING|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
188261|NCT01607112|B3|Baseline|Total|Total of all reporting groups
188262|NCT01607112|B2|Baseline|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188263|NCT01607112|B1|Baseline|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188264|NCT01607112|P2|Participant Flow|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188265|NCT01607112|P1|Participant Flow|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188266|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188267|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188268|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188269|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188270|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188271|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188272|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188273|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188274|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188275|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188276|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188277|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188278|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and did not receive seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188279|NCT01607112|O1|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and who had received seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188280|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188281|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188405|NCT01606319|P1|Participant Flow|Acetaminophen|"acetaminophen given as needed for pain or fever~Acetaminophen: 15 mg/kg every 6 hours as needed"
188282|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188283|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188284|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and did not receive seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188285|NCT01607112|O1|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and who had received seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188286|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and did not receive seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188287|NCT01607112|O1|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and who had received seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188288|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and did not receive seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188289|NCT01607112|O1|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and who had received seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188290|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188291|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188292|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188293|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188294|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188295|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188296|NCT01607112|E2|Reported Event|Elderly Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188297|NCT01607112|E1|Reported Event|Adult Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
188298|NCT01606852|B3|Baseline|Total|Total of all reporting groups
188299|NCT01606852|B2|Baseline|Patient Controlled Sedation|"Subjects will be given the hand actuator connected to a Lifecare PCA Infusion System in the PCA + continuous mode with the syringe filled with 4 ucg/ml of dexmedetomidine. A loading dose (0.5 mcg/kg) will be given followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Bedside RNs will adjust the basal rate to a maximum of based on the number of bolus requests in the prior two hours. Subjects can also receive bolus supplemental sedative medications (benzodiazepines and/or opioids)if needed in the judgment of the patient-care nurse.~Dexmedetomidine: loading dose (0.5 mcg/kg i.v.), followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Study infusion up to 5 days."
188300|NCT01606852|B1|Baseline|Usual Sedative Practice|"Subjects will have usual care sedation directed by their patient care team with no protocolized restriction on drug doses, selection or duration."
188301|NCT01606852|P2|Participant Flow|Patient Controlled Sedation|"Subjects will be given the hand actuator connected to a Lifecare PCA Infusion System in the PCA + continuous mode with the syringe filled with 4 ucg/ml of dexmedetomidine. A loading dose (0.5 mcg/kg) will be given followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Bedside RNs will adjust the basal rate to a maximum of based on the number of bolus requests in the prior two hours. Subjects can also receive bolus supplemental sedative medications (benzodiazepines and/or opioids)if needed in the judgment of the patient-care nurse.~Dexmedetomidine: loading dose (0.5 mcg/kg i.v.), followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Study infusion up to 5 days."
188302|NCT01606852|P1|Participant Flow|Usual Sedative Practice|"Subjects will have usual care sedation directed by their patient care team with no protocolized restriction on drug doses, selection or duration."
188323|NCT01606761|P4|Participant Flow|Placebo to 50 mg q4w Due to EE or CO|Participants who received matching placebo in the placebo controlled period were re-randomized (due to early escape [EE] at Week 18 or crossed over [CO] at Week 24) to receive subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
188840|NCT01605877|O1|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188303|NCT01606852|O2|Outcome|Patient Controlled Sedation|"Subjects will be given the hand actuator connected to a Lifecare PCA Infusion System in the PCA + continuous mode with the syringe filled with 4 ucg/ml of dexmedetomidine. A loading dose (0.5 mcg/kg) will be given followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Bedside RNs will adjust the basal rate to a maximum of based on the number of bolus requests in the prior two hours. Subjects can also receive bolus supplemental sedative medications (benzodiazepines and/or opioids)if needed in the judgment of the patient-care nurse.~Dexmedetomidine: loading dose (0.5 mcg/kg i.v.), followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Study infusion up to 5 days."
188304|NCT01606852|O1|Outcome|Usual Sedative Practice|"Subjects will have usual care sedation directed by their patient care team with no protocolized restriction on drug doses, selection or duration."
188305|NCT01606852|O2|Outcome|Patient Controlled Sedation|"Subjects will be given the hand actuator connected to a Lifecare PCA Infusion System in the PCA + continuous mode with the syringe filled with 4 ucg/ml of dexmedetomidine. A loading dose (0.5 mcg/kg) will be given followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Bedside RNs will adjust the basal rate to a maximum of based on the number of bolus requests in the prior two hours. Subjects can also receive bolus supplemental sedative medications (benzodiazepines and/or opioids)if needed in the judgment of the patient-care nurse.~Dexmedetomidine: loading dose (0.5 mcg/kg i.v.), followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Study infusion up to 5 days."
188306|NCT01606852|O1|Outcome|Usual Sedative Practice|"Subjects will have usual care sedation directed by their patient care team with no protocolized restriction on drug doses, selection or duration."
188307|NCT01606852|E2|Reported Event|Patient Controlled Sedation|"Subjects will be given the hand actuator connected to a Lifecare PCA Infusion System in the PCA + continuous mode with the syringe filled with 4 ucg/ml of dexmedetomidine. A loading dose (0.5 mcg/kg) will be given followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Bedside RNs will adjust the basal rate to a maximum of based on the number of bolus requests in the prior two hours. Subjects can also receive bolus supplemental sedative medications (benzodiazepines and/or opioids)if needed in the judgment of the patient-care nurse.~Dexmedetomidine: loading dose (0.5 mcg/kg i.v.), followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Study infusion up to 5 days."
188308|NCT01606852|E1|Reported Event|Usual Sedative Practice|"Subjects will have usual care sedation directed by their patient care team with no protocolized restriction on drug doses, selection or duration."
188309|NCT01606800|B3|Baseline|Total|Total of all reporting groups
188310|NCT01606800|B2|Baseline|20 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.
188311|NCT01606800|B1|Baseline|44 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks.
188312|NCT01606800|P2|Participant Flow|20 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.
188313|NCT01606800|P1|Participant Flow|44 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks.
188314|NCT01606800|O2|Outcome|20 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.
188315|NCT01606800|O1|Outcome|44 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks.
188316|NCT01606800|E2|Reported Event|20 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.
188317|NCT01606800|E1|Reported Event|44 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks.
188318|NCT01606761|B4|Baseline|Total|Total of all reporting groups
188319|NCT01606761|B3|Baseline|Sirukumab 100 mg q2w|All participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
188320|NCT01606761|B2|Baseline|Sirukumab 50 mg q4w|All participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
188321|NCT01606761|B1|Baseline|Placebo|Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52. Participants who discontinued or completed study agent administration before and up to Week 52 entered the safety follow-up period as well as those who completed through Week 52 were followed up for safety.
188322|NCT01606761|P5|Participant Flow|Placebo to 100 mg q2w Due to EE or CO|Participants who received matching placebo in the placebo controlled period were re-randomized (due to EE at Week 18 or CO at Week 24) to receive subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
188324|NCT01606761|P3|Participant Flow|Sirukumab 100 mg q2w|All participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
188325|NCT01606761|P2|Participant Flow|Sirukumab 50 mg q4w|All participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
188326|NCT01606761|P1|Participant Flow|Placebo|Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52. Participants who discontinued or completed study agent administration before and up to Week 52 entered the safety follow-up period as well as those who completed through Week 52 were followed up for safety.
188327|NCT01606761|O3|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52.
188328|NCT01606761|O2|Outcome|Sirukumab 50 mg|Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52.
188329|NCT01606761|O1|Outcome|Placebo|Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52.
188330|NCT01606761|O3|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52.
188331|NCT01606761|O2|Outcome|Sirukumab 50 mg|Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52.
188332|NCT01606761|O1|Outcome|Placebo|Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52.
188333|NCT01606761|O3|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52.
188334|NCT01606761|O2|Outcome|Sirukumab 50 mg|Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52.
188335|NCT01606761|O1|Outcome|Placebo|Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52.
188336|NCT01606761|O3|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52.
188337|NCT01606761|O2|Outcome|Sirukumab 50 mg|Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52.
188338|NCT01606761|O1|Outcome|Placebo|Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52.
188339|NCT01606761|E10|Reported Event|W52 to W68-Sirukumab 100 mg q2w|Participants who discontinued or completed sirukumab 100 mg q2w administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
188340|NCT01606761|E9|Reported Event|W52 to W68-Placebo to 100 mg q2w Due to EE or CO|Participants who discontinued or completed sirukumab 100 mg q2w due to EE or CO administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
188341|NCT01606761|E8|Reported Event|W52 to W68-Sirukumab 50 mg q4w|Participants who discontinued or completed sirukumab 50 mg q4w administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
188342|NCT01606761|E7|Reported Event|W52 to W68-Placebo to 50 mg q4w Due to EE or CO|Participants who discontinued or completed sirukumab 50 mg q4w due to EE or CO administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
188343|NCT01606761|E6|Reported Event|W52 to W68-Placebo|Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
188344|NCT01606761|E5|Reported Event|W52-Sirukumab 100 mg q2w|Participants received sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 52.
188345|NCT01606761|E4|Reported Event|W24 to W52-Placebo to 100 mg q2w Due to EE or CO|Participants who received matching placebo in the placebo controlled period and were re-randomized (due to early escape [EE] at Week 18 or crossed over [CO] at Week 24) to receive subcutaneous (SC) sirukumab 100 mg q4w dose regimen up to Week 52.
188346|NCT01606761|E3|Reported Event|W52-Sirukumab 50 mg q4w|Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52.
188347|NCT01606761|E2|Reported Event|W24 to W52-Placebo to 50 mg q4w Due to EE or CO|Participants who received matching placebo in the placebo controlled period and were re-randomized (due to early escape [EE] at Week 18 or crossed over [CO] at Week 24) to receive subcutaneous (SC) sirukumab 50 mg q4w dose regimen up to Week 52.
188348|NCT01606761|E1|Reported Event|Week (W) 24-Placebo|Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossover (CO) at Week 24.
188349|NCT01606748|B3|Baseline|Total|Total of all reporting groups
188350|NCT01606748|B2|Baseline|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
188351|NCT01606748|B1|Baseline|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
188352|NCT01606748|P2|Participant Flow|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 2 received necitumumab drug product manufactured using a new and comparable necitumumab drug substance (Process D drug product).~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
188353|NCT01606748|P1|Participant Flow|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an intravenous (IV) infusion at an absolute dose of 800 milligrams (mg). Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product. Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/square meter (m2).~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
188354|NCT01606748|O2|Outcome|Gemcitabine Cohort 1 Day 1, Cycle 1, Combination|Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.
188355|NCT01606748|O1|Outcome|Gemcitabine Cohort 1 Day 1 PK Run-in|Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
188356|NCT01606748|O2|Outcome|Necitumumab Cohort 1 Day 1, Cycle 1, Combination|Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
188357|NCT01606748|O1|Outcome|Necitumumab Cohort 1 Day 3 PK Run-In|Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg.
188358|NCT01606748|O2|Outcome|Cisplatin Cohort 1 Day 1, Cycle 1, Combination|Cisplatin administered 75 mg/m2 on Days 1 and 8 of every 3-week cycle as an IV infusion.
188359|NCT01606748|O1|Outcome|Cisplatin Cohort 1 Day 1 Run-in|Cisplatin administered on Day 1 of the 3-week PK run-in period as an IV infusion of 75 mg/m2.
188360|NCT01606748|O2|Outcome|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
188361|NCT01606748|O1|Outcome|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product. Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
188362|NCT01606748|O2|Outcome|Gemcitabine Cohort 1 Day 1, Cycle 1, Combination|Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.
188363|NCT01606748|O1|Outcome|Gemcitabine Cohort 1 Day 1 PK Run-in|Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
188364|NCT01606748|O2|Outcome|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
188365|NCT01606748|O1|Outcome|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product. Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
188366|NCT01606748|O2|Outcome|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
188367|NCT01606748|O1|Outcome|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
188841|NCT01605877|O2|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188368|NCT01606748|O2|Outcome|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
188369|NCT01606748|O1|Outcome|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product. Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
188370|NCT01606748|O2|Outcome|Necitumumab Cohort 1 Day 1, Cycle 1, Combination|Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
188371|NCT01606748|O1|Outcome|Necitumumab Cohort 1 Day 3 Run-In|Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg.
188372|NCT01606748|O2|Outcome|Cisplatin Cohort 1 Day 1, Cycle 1, Combination|Cisplatin administered 75 mg/m2 on Days 1 and 8 of every 3-week cycle as an IV infusion.
188373|NCT01606748|O1|Outcome|Cisplatin Cohort 1 Day 1 Run-in|Cisplatin administered on Day 1 of the 3-week PK run-in period as an IV infusion of 75 mg/m2.
188374|NCT01606748|O2|Outcome|Gemcitabine Cohort 1 Day 1, Cycle 1, Combination|Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.
188375|NCT01606748|O1|Outcome|Gemcitabine Cohort 1 Day 1 PK Run-In|Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
188376|NCT01606748|O2|Outcome|Necitumumab Cohort 1 Day 1, Cycle 1, Combination|Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
188377|NCT01606748|O1|Outcome|Necitumumab Cohort 1 Day 3 Run-in|Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
188378|NCT01606748|E2|Reported Event|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
188379|NCT01606748|E1|Reported Event|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
188380|NCT01606735|B4|Baseline|Total|Total of all reporting groups
188381|NCT01606735|B3|Baseline|697 mcg|IBI-10090: dexamethasone
188382|NCT01606735|B2|Baseline|517 mcg|IBI-10090: dexamethasone
188383|NCT01606735|B1|Baseline|342 mcg|IBI-10090: dexamethasone
188384|NCT01606735|P3|Participant Flow|697 mcg|IBI-10090: dexamethasone
188385|NCT01606735|P2|Participant Flow|517 mcg|IBI-10090: dexamethasone
188386|NCT01606735|P1|Participant Flow|342 mcg|IBI-10090: dexamethasone
188387|NCT01606735|O3|Outcome|697 mcg|IBI-10090: dexamethasone
188388|NCT01606735|O2|Outcome|517 mcg|IBI-10090: dexamethasone
188389|NCT01606735|O1|Outcome|342 mcg|IBI-10090: dexamethasone
188390|NCT01606735|E3|Reported Event|697 mcg|IBI-10090: dexamethasone
188391|NCT01606735|E2|Reported Event|517 mcg|IBI-10090: dexamethasone
188392|NCT01606735|E1|Reported Event|342 mcg|IBI-10090: dexamethasone
188393|NCT01606670|B1|Baseline|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
188394|NCT01606670|P1|Participant Flow|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
188395|NCT01606670|O1|Outcome|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
188396|NCT01606670|O1|Outcome|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
188397|NCT01606670|O1|Outcome|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
188398|NCT01606670|O1|Outcome|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
188399|NCT01606670|O1|Outcome|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
188400|NCT01606670|E1|Reported Event|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
188401|NCT01606319|B3|Baseline|Total|Total of all reporting groups
188402|NCT01606319|B2|Baseline|Ibuprofen|"ibuprofen given as needed for pain or fever~Ibuprofen: 9.4 mg/kg every 6 hours as needed"
188403|NCT01606319|B1|Baseline|Acetaminophen|"acetaminophen given as needed for pain or fever~Acetaminophen: 15 mg/kg every 6 hours as needed"
194322|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
188406|NCT01606319|O2|Outcome|Ibuprofen|"ibuprofen given as needed for pain or fever~Ibuprofen: 9.4 mg/kg every 6 hours as needed"
188407|NCT01606319|O1|Outcome|Acetaminophen|"acetaminophen given as needed for pain or fever~Acetaminophen: 15 mg/kg every 6 hours as needed"
188408|NCT01606319|O2|Outcome|Ibuprofen|"ibuprofen given as needed for pain or fever~Ibuprofen: 9.4 mg/kg every 6 hours as needed"
188409|NCT01606319|O1|Outcome|Acetaminophen|"acetaminophen given as needed for pain or fever~Acetaminophen: 15 mg/kg every 6 hours as needed"
188410|NCT01606319|O2|Outcome|Ibuprofen|"ibuprofen given as needed for pain or fever~Ibuprofen: 9.4 mg/kg every 6 hours as needed"
188411|NCT01606319|O1|Outcome|Acetaminophen|"acetaminophen given as needed for pain or fever~Acetaminophen: 15 mg/kg every 6 hours as needed"
188412|NCT01606319|O2|Outcome|Ibuprofen|"ibuprofen given as needed for pain or fever~Ibuprofen: 9.4 mg/kg every 6 hours as needed"
188413|NCT01606319|O1|Outcome|Acetaminophen|"acetaminophen given as needed for pain or fever~Acetaminophen: 15 mg/kg every 6 hours as needed"
188414|NCT01606319|E2|Reported Event|Ibuprofen|"ibuprofen given as needed for pain or fever~Ibuprofen: 9.4 mg/kg every 6 hours as needed"
188415|NCT01606319|E1|Reported Event|Acetaminophen|"acetaminophen given as needed for pain or fever~Acetaminophen: 15 mg/kg every 6 hours as needed"
188416|NCT01606306|B7|Baseline|Total|Total of all reporting groups
188417|NCT01606306|B6|Baseline|Crossover Sequence 6|as needed fluticasone propionate, followed by daily montelukast, followed by daily fluticasone propionate
188418|NCT01606306|B5|Baseline|Crossover Sequence 5|as needed fluticasone propionate, followed by daily fluticasone propionate, followed by daily montelukast
188419|NCT01606306|B4|Baseline|Crossover Sequence 4|daily montelukast, followed by daily fluticasone propionate, followed by as needed fluticasone propionate
188420|NCT01606306|B3|Baseline|Crossover Sequence 3|daily montelukast, followed by as needed fluticasone propionate, followed by daily fluticasone propionate
188421|NCT01606306|B2|Baseline|Crossover Sequence 2|daily fluticasone propionate, followed by as needed fluticasone propionate, followed by daily montelukast
188422|NCT01606306|B1|Baseline|Crossover Sequence 1|daily fluticasone propionate, followed by daily montelukast, followed by as needed fluticasone propionate
188423|NCT01606306|P6|Participant Flow|Crossover Sequence 6|as needed fluticasone propionate, followed by daily montelukast, followed by daily fluticasone propionate
188424|NCT01606306|P5|Participant Flow|Crossover Sequence 5|as needed fluticasone propionate, followed by daily fluticasone propionate, followed by daily montelukast
188425|NCT01606306|P4|Participant Flow|Crossover Sequence 4|daily montelukast, followed by daily fluticasone propionate, followed by as needed fluticasone propionate
188426|NCT01606306|P3|Participant Flow|Crossover Sequence 3|daily montelukast, followed by as needed fluticasone propionate, followed by daily fluticasone propionate
188427|NCT01606306|P2|Participant Flow|Crossover Sequence 2|daily fluticasone propionate, followed by as needed fluticasone propionate, followed by daily montelukast
188428|NCT01606306|P1|Participant Flow|Crossover Sequence 1|daily fluticasone propionate, followed by daily montelukast, followed by as needed fluticasone propionate
188429|NCT01606306|O1|Outcome|All Evaluable Participants|Differential response was determined in children completing at least two treatment periods and at least 50% of the daily diary entries for each period. Because placebo washouts were not performed, the data collected during the first two weeks of each period were not included in the analysis of ACDs. Days with missing diary data were also excluded from ACD determination.
188430|NCT01606306|E3|Reported Event|Daily LTRA|Daily leukotriene receptor antagonist (LTRA) treatment
188431|NCT01606306|E2|Reported Event|As-needed ICS|As-needed ICS plus short-acting beta agonist (as-needed ICS/SABA) rescue treatment.
188432|NCT01606306|E1|Reported Event|Daily ICS|Daily inhaled corticosteroid (ICS) treatment
188433|NCT01606254|B5|Baseline|Total|Total of all reporting groups
188434|NCT01606254|B4|Baseline|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
188435|NCT01606254|B3|Baseline|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
188436|NCT01606254|B2|Baseline|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
188437|NCT01606254|B1|Baseline|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
188438|NCT01606254|P4|Participant Flow|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
188439|NCT01606254|P3|Participant Flow|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
188440|NCT01606254|P2|Participant Flow|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
188441|NCT01606254|P1|Participant Flow|Paliperidone Palmitate 50 mg|Paliperidone palmitate (JNS010) 50 milligram (mg) intramuscular (into the muscle) injection administered on Days 1, 8, 36 and 64.
188442|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
188443|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
188444|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
188445|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
188446|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
188447|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
188448|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
188449|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
188450|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
188451|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
188452|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
188453|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
188454|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
188455|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
188456|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
188457|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
188458|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
188459|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
188460|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
188461|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
188462|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
188463|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
188464|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
188465|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
188466|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
188467|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
188468|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
188469|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
188470|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
188471|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
188472|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
188473|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
188474|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
188475|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
188476|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
188477|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
188478|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
188479|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
188480|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
188481|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
188482|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
188483|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
188484|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
188485|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
188486|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
188487|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
188488|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
188489|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
188490|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
188491|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
188492|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
188493|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
188494|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
188495|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
188496|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
188497|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
188498|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
188499|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
188500|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
188501|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
188502|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
188503|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
188504|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
188505|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
188506|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
188507|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
188508|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
188509|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
188510|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
188511|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
188512|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
188513|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
188514|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
188515|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
188516|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
188517|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
188518|NCT01606254|E4|Reported Event|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
188519|NCT01606254|E3|Reported Event|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
188520|NCT01606254|E2|Reported Event|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
188521|NCT01606254|E1|Reported Event|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
188522|NCT01606228|B1|Baseline|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
188523|NCT01606228|P1|Participant Flow|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
188524|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
188525|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
188526|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
188527|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
188528|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
188529|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
188530|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
188531|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
188532|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
188533|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
188534|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
188535|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
188536|NCT01606228|E1|Reported Event|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
188537|NCT01606202|B3|Baseline|Total|Total of all reporting groups
188538|NCT01606202|B2|Baseline|Placebo|Placebo control.
188539|NCT01606202|B1|Baseline|GW-1000-02|Active treatment.
188540|NCT01606202|P2|Participant Flow|Placebo|Placebo control.The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
188541|NCT01606202|P1|Participant Flow|GW-1000-02|Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period (THC 130 mg : CBD 120 mg).
188542|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
188543|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
188544|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
188545|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
188546|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
188547|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
188548|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
188549|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
188550|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
188551|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
188552|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
188553|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
188554|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
188555|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
188556|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
188557|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
188558|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
188559|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
188560|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
188561|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
188562|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
188563|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
188564|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
188634|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
188565|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
188566|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
188567|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
188568|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
188569|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
188570|NCT01606202|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
188571|NCT01606202|E1|Reported Event|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
188572|NCT01606189|B1|Baseline|All Study Treatments: GW-1000-02, GW-2000-02 and Placebo|As this was a crossover study design, all patients were to receive all study treatments: GW-1000-02, GW-2000-02 and placebo.
188573|NCT01606189|P6|Participant Flow|GW-2000-02 First, Then Placebo, Then GW-1000-02|"GW-2000-02 first (14-20 days), then GW-1000-02 (14-20 days), then placebo (14-20 days).~Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
188574|NCT01606189|P5|Participant Flow|Placebo First, Then GW-2000-02, Then GW-1000-02|"Placebo first (14-20 days), then GW-1000-02 (14-20 days), then GW-2000-02 (14-20 days).~Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
188575|NCT01606189|P4|Participant Flow|GW-1000-02 First, Then Placebo, Then GW-2000-02|"GW-1000-02 first (14-20 days), then placebo (14-20 days), then GW-2000-02 (14-20 days).~Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
188576|NCT01606189|P3|Participant Flow|Placebo First, Then GW-1000-02, Then GW-2000-02|"Placebo first (14-20 days), then GW-1000-02 (14-20 days), then GW-2000-02 (14-20 days).~Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
188577|NCT01606189|P2|Participant Flow|GW-2000-02 First, Then GW-1000-02, Then Placebo|"GW-2000-02 first (14-20 days), then GW-1000-02 (14-20 days), then placebo (14-20 days).~Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
188578|NCT01606189|P1|Participant Flow|GW-1000-02 First, Then GW-2000-02, Then Placebo|"GW-1000-02 first (14-20 days), then GW-2000-02 (14-20 days), then placebo (14-20 days).~Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
188579|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
188580|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
188581|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
188582|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
188583|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
188584|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
188585|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
188586|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
188587|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
188588|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
188589|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
188590|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
188591|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
188592|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
188593|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
188594|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
188595|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
188596|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
188597|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
188598|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
188599|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
188600|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
188601|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
188602|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
188603|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
188604|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
188605|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
188606|NCT01606189|E3|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
188607|NCT01606189|E2|Reported Event|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
188608|NCT01606189|E1|Reported Event|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
188609|NCT01606176|B3|Baseline|Total|Total of all reporting groups
188610|NCT01606176|B2|Baseline|Placebo|Placebo control.
188611|NCT01606176|B1|Baseline|GW-1000-02|Active treatment.
188612|NCT01606176|P2|Participant Flow|Placebo|Placebo control. The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
188613|NCT01606176|P1|Participant Flow|GW-1000-02|Each actuation of oromucosal spray delivers 2.5mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period (THC 120 mg : CBD 120 mg).
188614|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
188615|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
188616|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
188617|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
188618|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
188619|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
188620|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
188621|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
188622|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
188623|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
188624|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
188625|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
188626|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
188627|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
188628|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
188629|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
188630|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
188631|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
188632|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
188633|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
188635|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
188636|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
188637|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
188638|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
188639|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
188640|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
188641|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
188642|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
188643|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
188644|NCT01606176|E2|Reported Event|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
188645|NCT01606176|E1|Reported Event|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
188646|NCT01606150|B3|Baseline|Total|Total of all reporting groups
188647|NCT01606150|B2|Baseline|Topical Lidocaine|"LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure~topical lidocaine: 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure"
188648|NCT01606150|B1|Baseline|Subcutaneous Lidocaine|"0.1 ml/kg of 1% Lidocaine~1% lidocaine: 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure"
188649|NCT01606150|P2|Participant Flow|Topical Lidocaine|"LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure~topical lidocaine: 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure"
188650|NCT01606150|P1|Participant Flow|Subcutaneous Lidocaine|"0.1 ml/kg of 1% Lidocaine~1% lidocaine: 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure"
188651|NCT01606150|O2|Outcome|Topical Lidocaine|"LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure~topical lidocaine: 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure"
188652|NCT01606150|O1|Outcome|Subcutaneous Lidocaine|"0.1 ml/kg of 1% Lidocaine~1% lidocaine: 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure"
188653|NCT01606150|O2|Outcome|Topical Lidocaine|"LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure~topical lidocaine: 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure"
188654|NCT01606150|O1|Outcome|Subcutaneous Lidocaine|"0.1 ml/kg of 1% Lidocaine~1% lidocaine: 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure"
188655|NCT01606150|E2|Reported Event|Topical Lidocaine|"LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure~topical lidocaine: 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure"
188656|NCT01606150|E1|Reported Event|Subcutaneous Lidocaine|"0.1 ml/kg of 1% Lidocaine~1% lidocaine: 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure"
188657|NCT01606137|B1|Baseline|GW-1000-02|Active treatment
188658|NCT01606137|P1|Participant Flow|GW-1000-02|Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period (THC 130 mg : CBD 120 mg).
188659|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
188660|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
188661|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
188662|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
188663|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
188664|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
188665|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
188666|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
188667|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
188668|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
188669|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
188670|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
188671|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
188672|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
188673|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
188674|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
188675|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
188676|NCT01606137|E1|Reported Event|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
188677|NCT01606124|B3|Baseline|Total|Total of all reporting groups
188678|NCT01606124|B2|Baseline|Arm II (Placebo)|Patients receive two capsules placebo PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
188679|NCT01606124|B1|Baseline|Arm I (Polyphenon E)|Patients receive two capsules Polyphenon E (each capsule of Polyphenon E contains approximately 200 mg epigallocatechin gallate (EGCG)) PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
188680|NCT01606124|P2|Participant Flow|Arm II (Placebo)|Patients receive two capsules placebo PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
188681|NCT01606124|P1|Participant Flow|Arm I (Polyphenon E)|Patients receive two capsules Polyphenon E (each capsule of Polyphenon E contains approximately 200 mg epigallocatechin gallate (EGCG)) PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
188682|NCT01606124|O2|Outcome|Arm II (Placebo)|Patients receive two capsules placebo PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
188683|NCT01606124|O1|Outcome|Arm I (Polyphenon E)|Patients receive two capsules Polyphenon E (each capsule of Polyphenon E contains approximately 200 mg epigallocatechin gallate (EGCG)) PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
188684|NCT01606124|O2|Outcome|Arm II (Placebo)|Patients receive two capsules placebo PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
188685|NCT01606124|O1|Outcome|Arm I (Polyphenon E)|Patients receive two capsules Polyphenon E (each capsule of Polyphenon E contains approximately 200 mg epigallocatechin gallate (EGCG)) PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
188686|NCT01606124|E2|Reported Event|Arm II (Placebo)|Patients receive two capsules placebo PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
188687|NCT01606124|E1|Reported Event|Arm I (Polyphenon E)|Patients receive two capsules Polyphenon E (each capsule of Polyphenon E contains approximately 200 mg epigallocatechin gallate (EGCG)) PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
188688|NCT01606007|B4|Baseline|Total|Total of all reporting groups
188689|NCT01606007|B3|Baseline|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
188690|NCT01606007|B2|Baseline|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
188691|NCT01606007|B1|Baseline|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
188692|NCT01606007|P3|Participant Flow|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
188693|NCT01606007|P2|Participant Flow|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
188694|NCT01606007|P1|Participant Flow|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
188695|NCT01606007|O3|Outcome|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
188696|NCT01606007|O2|Outcome|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
188697|NCT01606007|O1|Outcome|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
188726|NCT01605916|B3|Baseline|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
194323|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
188698|NCT01606007|O3|Outcome|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
188699|NCT01606007|O2|Outcome|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
188700|NCT01606007|O1|Outcome|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
188701|NCT01606007|O3|Outcome|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
188702|NCT01606007|O2|Outcome|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
188703|NCT01606007|O1|Outcome|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
188704|NCT01606007|O3|Outcome|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
188705|NCT01606007|O2|Outcome|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
188706|NCT01606007|O1|Outcome|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
188707|NCT01606007|O3|Outcome|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
188708|NCT01606007|O2|Outcome|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
188709|NCT01606007|O1|Outcome|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
188710|NCT01606007|E3|Reported Event|SAXA + DAPA + MET|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
188711|NCT01606007|E2|Reported Event|DAPA + MET|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
188712|NCT01606007|E1|Reported Event|SAXA + MET|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
188713|NCT01605942|B3|Baseline|Total|Total of all reporting groups
188714|NCT01605942|B2|Baseline|Placebo Drug Delivery System|Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
188715|NCT01605942|B1|Baseline|Dexamethasone Drug Delivery System|Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
188716|NCT01605942|P2|Participant Flow|Placebo Drug Delivery System|Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
188717|NCT01605942|P1|Participant Flow|Dexamethasone Drug Delivery System|Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
188718|NCT01605942|O1|Outcome|Dexamethasone Drug Delivery System|Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
188719|NCT01605942|O2|Outcome|Placebo Drug Delivery System|Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
188720|NCT01605942|O1|Outcome|Dexamethasone Drug Delivery System|Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
188721|NCT01605942|E2|Reported Event|Placebo Drug Delivery System|Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
188722|NCT01605942|E1|Reported Event|Dexamethasone Drug Delivery System|Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
188723|NCT01605916|B6|Baseline|Total|Total of all reporting groups
188724|NCT01605916|B5|Baseline|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
188725|NCT01605916|B4|Baseline|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
188829|NCT01605877|O4|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188727|NCT01605916|B2|Baseline|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188728|NCT01605916|B1|Baseline|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188729|NCT01605916|P5|Participant Flow|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
188730|NCT01605916|P4|Participant Flow|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
188731|NCT01605916|P3|Participant Flow|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
188732|NCT01605916|P2|Participant Flow|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188733|NCT01605916|P1|Participant Flow|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188734|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188735|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188736|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188737|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188738|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188739|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188740|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
188741|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
188742|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
188743|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188744|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188745|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
188746|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
188747|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
188748|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188749|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188750|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
188751|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
188752|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
188753|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188754|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188755|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
188756|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
188757|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
188758|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188830|NCT01605877|O3|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
194324|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
188759|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188760|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
188761|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
188762|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
188763|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188764|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188765|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
188766|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
188767|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
188768|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188769|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188770|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
188771|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
188772|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
188773|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188774|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188775|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
188776|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
188777|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
188778|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188779|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188780|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
188781|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
188782|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
188783|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188784|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188785|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
188786|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
188787|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
188788|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188789|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188790|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
188791|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
188792|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
188831|NCT01605877|O2|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188832|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188793|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188794|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188795|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
188796|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
188797|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
188798|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188799|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188800|NCT01605916|E5|Reported Event|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
188801|NCT01605916|E4|Reported Event|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
188802|NCT01605916|E3|Reported Event|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
188803|NCT01605916|E2|Reported Event|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188804|NCT01605916|E1|Reported Event|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
188805|NCT01605903|B3|Baseline|Total|Total of all reporting groups
188806|NCT01605903|B2|Baseline|Treatment With Acetaminophen|"Children will be randomly assigned to either the treatment arm or active comparator prior to surgery. Children in the active comparator group (Acetaminophen) will receive grape flavored 160 mg/5 ml acetaminophen. Acetaminophen will be dispensed at 15 mg/kg (max dose 650/mg) Q6.~Acetaminophen: During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6."
188807|NCT01605903|B1|Baseline|Treatment With Ibuprofen|"Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery. Children in the ibuprofen group will be receive grape-flavored ibuprofen 100mg/5 mL. During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6.~Ibuprofen: Children in the ibuprofen group will be receive grape-flavored ibuprofen 100mg/5 mL. During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6."
188808|NCT01605903|P2|Participant Flow|Treatment With Acetaminophen|"Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery.~Acetaminophen: During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6."
188809|NCT01605903|P1|Participant Flow|Treatment With Ibuprofen|"Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery.~Ibuprofen: Children in the ibuprofen group will be receive grape-flavored ibuprofen 100mg/5 mL. During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6."
188810|NCT01605903|O2|Outcome|Treatment With Acetaminophen|"Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery.~Acetaminophen: During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6."
188811|NCT01605903|O1|Outcome|Treatment With Ibuprofen|"Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery.~Ibuprofen: Children in the ibuprofen group will be receive grape-flavored ibuprofen 100mg/5 mL. During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6."
188812|NCT01605903|E2|Reported Event|Treatment With Acetaminophen|"Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery.~Acetaminophen: During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6."
188813|NCT01605903|E1|Reported Event|Treatment With Ibuprofen|"Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery.~Ibuprofen: Children in the ibuprofen group will be receive grape-flavored ibuprofen 100mg/5 mL. During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6."
188814|NCT01605877|B1|Baseline|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation
188815|NCT01605877|P1|Participant Flow|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation
188816|NCT01605877|O1|Outcome|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188817|NCT01605877|O1|Outcome|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188818|NCT01605877|O1|Outcome|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188819|NCT01605877|O1|Outcome|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188820|NCT01605877|O2|Outcome|SN6AD2, as Measured With VCTS|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188821|NCT01605877|O1|Outcome|SN6AD2, as Measured With CSV-1000|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188822|NCT01605877|O5|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188823|NCT01605877|O4|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188824|NCT01605877|O3|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188825|NCT01605877|O2|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188826|NCT01605877|O1|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188827|NCT01605877|O6|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188828|NCT01605877|O5|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188842|NCT01605877|O1|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188843|NCT01605877|O2|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188844|NCT01605877|O1|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188845|NCT01605877|O2|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188846|NCT01605877|O1|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188847|NCT01605877|O4|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188848|NCT01605877|O3|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188849|NCT01605877|O2|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188850|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188851|NCT01605877|O6|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188852|NCT01605877|O5|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188853|NCT01605877|O4|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188854|NCT01605877|O3|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188855|NCT01605877|O2|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188856|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188857|NCT01605877|O6|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188858|NCT01605877|O5|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188859|NCT01605877|O4|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188860|NCT01605877|O3|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188861|NCT01605877|O2|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188862|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188863|NCT01605877|O6|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188864|NCT01605877|O5|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188865|NCT01605877|O4|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188866|NCT01605877|O3|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188867|NCT01605877|O2|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188868|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188869|NCT01605877|O6|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188870|NCT01605877|O5|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188871|NCT01605877|O4|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188872|NCT01605877|O3|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188873|NCT01605877|O2|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188874|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
188875|NCT01605877|E1|Reported Event|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation
188876|NCT01605825|B3|Baseline|Total|Total of all reporting groups
188877|NCT01605825|B2|Baseline|Dalfampridine-ER/Placebo|"Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:~Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36~dalfampridine-ER: Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2.~10mg tablets, will be taken orally, twice daily approximately 12 hours apart"
188878|NCT01605825|B1|Baseline|Placebo/Dalfampridine-ER|"Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:~Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36~dalfampridine-ER: Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2.~10mg tablets, will be taken orally, twice daily approximately 12 hours apart"
188879|NCT01605825|P2|Participant Flow|Dalfampridine-ER/Placebo|"Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:~Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36~dalfampridine-ER: Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2.~10mg tablets, will be taken orally, twice daily approximately 12 hours apart"
188880|NCT01605825|P1|Participant Flow|Placebo/Dalfampridine-ER|"Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:~Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36~dalfampridine-ER: Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2.~10mg tablets, will be taken orally, twice daily approximately 12 hours apart"
188881|NCT01605825|O2|Outcome|Dalfampridine-ER|
188882|NCT01605825|O1|Outcome|Placebo|
188883|NCT01605825|E2|Reported Event|Dalfampridine-ER|
188884|NCT01605825|E1|Reported Event|Placebo|
188885|NCT01605799|B3|Baseline|Total|Total of all reporting groups
188886|NCT01605799|B2|Baseline|Wait List Control Group|"Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.~Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment."
188887|NCT01605799|B1|Baseline|IOK Treatment|"Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war."
188913|NCT01605617|O1|Outcome|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo
189602|NCT01603043|B2|Baseline|Sham Injection|1 mock injection per month for 12 months
188888|NCT01605799|P2|Participant Flow|Wait List Control Group|"Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.~Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment."
188889|NCT01605799|P1|Participant Flow|IOK Treatment|"Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war."
188890|NCT01605799|O2|Outcome|Wait List Control Group|"Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.~Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment."
188891|NCT01605799|O1|Outcome|IOK Treatment|"Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war."
188892|NCT01605799|O2|Outcome|Wait List Control Group|"Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.~Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment."
188893|NCT01605799|O1|Outcome|IOK Treatment|"Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war."
188894|NCT01605799|E2|Reported Event|Wait List Control Group|"Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.~Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment."
188895|NCT01605799|E1|Reported Event|IOK Treatment|"Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war."
188896|NCT01605669|B1|Baseline|Aortic Stenosis Patients|Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study.
188897|NCT01605669|P1|Participant Flow|Aortic Stenosis Patients|Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study.
188898|NCT01605669|O2|Outcome|Mean Pressure Gradient <30mmHg (Negative)|
188899|NCT01605669|O1|Outcome|Mean Pressure Gradient >=30mmHg (Positive)|Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study.
188900|NCT01605669|E1|Reported Event|Aortic Stenosis Patients|Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study.
188901|NCT01605617|B3|Baseline|Total|Total of all reporting groups
188902|NCT01605617|B2|Baseline|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given Percutaneous Tibial Nerve Stimulation (PTNS) + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate.
188903|NCT01605617|B1|Baseline|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given Percutaneous Tibial Nerve Stimulation (PTNS) + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo.
188904|NCT01605617|P2|Participant Flow|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo (12 weeks), washout (4 weeks), PTNS + 4mg of fesoterodine fumarate (12 weeks)
188905|NCT01605617|P1|Participant Flow|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate (12 weeks), Washout (4 weeks), PTNS + placebo (12 weeks)
188906|NCT01605617|O2|Outcome|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate
188907|NCT01605617|O1|Outcome|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo
188908|NCT01605617|O2|Outcome|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate
188909|NCT01605617|O1|Outcome|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo
188910|NCT01605617|O2|Outcome|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate
188911|NCT01605617|O1|Outcome|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo
188912|NCT01605617|O2|Outcome|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate
189088|NCT01604408|O2|Outcome|Placebo|Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.
188914|NCT01605617|O2|Outcome|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate
188915|NCT01605617|O1|Outcome|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo
188916|NCT01605617|O2|Outcome|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate
188917|NCT01605617|O1|Outcome|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo
188918|NCT01605617|E4|Reported Event|While on PTNS + Fesoterodine Fumarate Second|Participants were to be given PTNS + 4mg of fesoterodine fumarate (12 weeks)
188919|NCT01605617|E3|Reported Event|While on PTNS + Placebo Second|Participants were to be given PTNS + placebo (12 weeks)
188920|NCT01605617|E2|Reported Event|While on PTNS + Placebo First|Participants were given PTNS + placebo (12 weeks)
188921|NCT01605617|E1|Reported Event|While on PTNS + Fesoterodine Fumarate First|Participants were given PTNS + 4mg of fesoterodine fumarate (12 weeks)
188922|NCT01605552|B3|Baseline|Total|Total of all reporting groups
188923|NCT01605552|B2|Baseline|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.~Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
188924|NCT01605552|B1|Baseline|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)~Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
188925|NCT01605552|P2|Participant Flow|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.~Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
188926|NCT01605552|P1|Participant Flow|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)~Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
188927|NCT01605552|O2|Outcome|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.~Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
188928|NCT01605552|O1|Outcome|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)~Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
188938|NCT01605539|B2|Baseline|CBD Group|"The two arms (400 mg and 800 mg of Cannabidiol) were combined for analysis because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Cannabidiol: Subjects in Arm CBD Group received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
188929|NCT01605552|O2|Outcome|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.~Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
188930|NCT01605552|O1|Outcome|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)~Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
188931|NCT01605552|O2|Outcome|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.~Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
188932|NCT01605552|O1|Outcome|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)~Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
188933|NCT01605552|O2|Outcome|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.~Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
188934|NCT01605552|O1|Outcome|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)~Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
188935|NCT01605552|E2|Reported Event|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.~Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
188936|NCT01605552|E1|Reported Event|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)~Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
188937|NCT01605539|B3|Baseline|Total|Total of all reporting groups
188995|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
188939|NCT01605539|B1|Baseline|Control|"Subjects received pills that resemble the Cannabidiol capsule but did not have its properties.~Control: Subjects receivd a harmless, inactive pill to compare and validate the results of the other arms of the study"
188940|NCT01605539|P3|Participant Flow|CBD 800 Group|Subjects in Arm CBD 800 will receive 800 mg of Cannabidiol in each of the three test sessions
188941|NCT01605539|P2|Participant Flow|CBD 400 Group|"Subjects will receive 400 mg of cannabidiol~Subjects in Arm CBD 400 will receive 400 mg of Cannabidiol in each of the three test sessions"
188942|NCT01605539|P1|Participant Flow|Control|"Subjects will receive pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects will receive a harmless, inactive pill to compare and validate the results of the other arms of the study"
188943|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
188944|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
188945|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
188946|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
188947|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
188948|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
188949|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
188950|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
188951|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
188952|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
188953|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
188954|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
188955|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
188956|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
188957|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD will receive 400 mg or 800mg of Cannabidiol in each of the three test sessions"
188958|NCT01605539|O1|Outcome|Control|"Subjects received pills that resembled the Cannabidiol capsule but did not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
188959|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol.The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Cannabidiol: Subjects in Arm CBD Group received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
188960|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
188961|NCT01605539|E2|Reported Event|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol.The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
188962|NCT01605539|E1|Reported Event|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
188963|NCT01605461|B1|Baseline|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
188964|NCT01605461|P1|Participant Flow|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
188965|NCT01605461|O1|Outcome|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
188966|NCT01605461|O1|Outcome|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
188967|NCT01605461|O1|Outcome|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
188968|NCT01605461|O1|Outcome|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
188969|NCT01605461|O1|Outcome|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
188970|NCT01605461|O1|Outcome|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
188971|NCT01605461|E1|Reported Event|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
188972|NCT01605370|B3|Baseline|Total|Total of all reporting groups
188973|NCT01605370|B2|Baseline|Metoprolol Succinate|"Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily.~Metoprolol succinate: Metoprolol succinate 50 mg once daily"
188974|NCT01605370|B1|Baseline|Nebivolol|"Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily.~Nebivolol: Nebivolol 2.5 mg once daily"
188975|NCT01605370|P2|Participant Flow|Metoprolol Succinate|"Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily.~Metoprolol succinate: Metoprolol succinate 50 mg once daily"
188976|NCT01605370|P1|Participant Flow|Nebivolol|"Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily.~Nebivolol: Nebivolol 2.5 mg once daily"
188977|NCT01605370|O2|Outcome|Metoprolol Succinate|"Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily.~Metoprolol succinate: Metoprolol succinate 50 mg once daily"
188978|NCT01605370|O1|Outcome|Nebivolol|"Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily.~Nebivolol: Nebivolol 2.5 mg once daily"
188979|NCT01605370|E2|Reported Event|Metoprolol Succinate|"Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily.~Metoprolol succinate: Metoprolol succinate 50 mg once daily"
188980|NCT01605370|E1|Reported Event|Nebivolol|"Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily.~Nebivolol: Nebivolol 2.5 mg once daily"
188981|NCT01605292|B3|Baseline|Total|Total of all reporting groups
188982|NCT01605292|B2|Baseline|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
188983|NCT01605292|B1|Baseline|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
188984|NCT01605292|P2|Participant Flow|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
188985|NCT01605292|P1|Participant Flow|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
188986|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
188987|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
188988|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
188989|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
188990|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
188991|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
188992|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
188993|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
188994|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
188996|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
188997|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
188998|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
188999|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
189000|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
189001|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
189002|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
189003|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
189004|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
189005|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
189006|NCT01605292|E2|Reported Event|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
189007|NCT01605292|E1|Reported Event|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
189008|NCT01605227|B3|Baseline|Total|Total of all reporting groups
189009|NCT01605227|B2|Baseline|Prednisone|"Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.~Prednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily."
189010|NCT01605227|B1|Baseline|Cabozantinib|"Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.~Cabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily."
189011|NCT01605227|P2|Participant Flow|Prednisone|"Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.~Prednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily."
189012|NCT01605227|P1|Participant Flow|Cabozantinib|"Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.~Cabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily."
189013|NCT01605227|O2|Outcome|Prednisone|"Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.~Prednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily."
189014|NCT01605227|O1|Outcome|Cabozantinib|"Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.~Cabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily."
189015|NCT01605227|O2|Outcome|Prednisone|"Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.~Prednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily."
189016|NCT01605227|O1|Outcome|Cabozantinib|"Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.~Cabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily."
189017|NCT01605227|O2|Outcome|Prednisone|"Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.~Prednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily."
189018|NCT01605227|O1|Outcome|Cabozantinib|"Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.~Cabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily."
189019|NCT01605227|E2|Reported Event|Prednisone|"Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.~Prednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily."
189020|NCT01605227|E1|Reported Event|Cabozantinib|"Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.~Cabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily."
189021|NCT01604941|B3|Baseline|Total|Total of all reporting groups
189022|NCT01604941|B2|Baseline|SPD602 75mg/kg/Day|Participants received SPD602 75mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
189023|NCT01604941|B1|Baseline|SPD602 50mg/kg/Day|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
189024|NCT01604941|P6|Participant Flow|SPD602 75mg/kg/Day Once Daily Dosing (QD)|Participants were randomly assigned to 75 mg/kg/day oral QD dosing and continued QD dosing until the end of study (24 weeks) or early discontinuation.
189025|NCT01604941|P5|Participant Flow|SPD602 50mg/kg/Day Once Daily Dosing (QD)|Participants were randomly assigned to 50 mg/kg/day oral QD dosing and continued QD dosing until the end of study (24 weeks) or early discontinuation.
189026|NCT01604941|P4|Participant Flow|SPD602 75mg/kg/Day Once (QD) Then Twice Daily Dosing (BID)|Participants were randomly assigned to QD dosing then re-enrolled to 75 mg/kg/day oral BID dosing and continued BID dosing until the end of study (24 weeks) or early discontinuation.
189057|NCT01604850|P2|Participant Flow|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
189027|NCT01604941|P3|Participant Flow|SPD602 50mg/kg/Day Once (QD) Then Twice Daily Dosing (BID)|Participants were randomly assigned to QD dosing then re-enrolled to 50 mg/kg/day oral BID dosing and continued BID dosing until the end of study (24 weeks) or early discontinuation.
189028|NCT01604941|P2|Participant Flow|SPD602 75mg/kg/Day Twice Daily Dosing (BID)|Participants were randomly assigned to 75 mg/kg/day oral BID dosing and continued BID dosing until the end of study (24 weeks) or early discontinuation.
189029|NCT01604941|P1|Participant Flow|SPD602 50mg/mg/Day Twice Daily Dosing (BID)|Participants were randomly assigned to 50 mg/kg/day oral BID dosing and continued BID dosing until the end of study (24 weeks) or early discontinuation.
189030|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
189031|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
189032|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
189033|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
189034|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
189035|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
189036|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
189037|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
189038|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
189039|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
189040|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
189041|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
189042|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
189043|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
189044|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
189045|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
189046|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
189047|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
189048|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
189049|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
189050|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
189051|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
189052|NCT01604941|E2|Reported Event|SPD602 75mg/kg/Day|Participants received SPD602 75mg/kg/day oral dosing BID either as originally randomized or as a re-enrolled participant.
189053|NCT01604941|E1|Reported Event|SPD602 50mg/kg/Day|Participants received SPD602 50mg/kg/day oral dosing BID either as originally randomized or as a re-enrolled participant.
189054|NCT01604850|B3|Baseline|Total|Total of all reporting groups
189055|NCT01604850|B2|Baseline|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
189056|NCT01604850|B1|Baseline|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
189058|NCT01604850|P1|Participant Flow|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir (SOF)+ribavirin (RBV) for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
189059|NCT01604850|O2|Outcome|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
189060|NCT01604850|O1|Outcome|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
189061|NCT01604850|O2|Outcome|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
189062|NCT01604850|O1|Outcome|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
189063|NCT01604850|O2|Outcome|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
189064|NCT01604850|O1|Outcome|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
189065|NCT01604850|O2|Outcome|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
189066|NCT01604850|O1|Outcome|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
189067|NCT01604850|O2|Outcome|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
189068|NCT01604850|O1|Outcome|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
189069|NCT01604850|O2|Outcome|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
189070|NCT01604850|O1|Outcome|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
189071|NCT01604850|E2|Reported Event|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
189072|NCT01604850|E1|Reported Event|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
189073|NCT01604772|B1|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: 150 mg given PO"
189074|NCT01604772|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: 150 mg given PO"
189075|NCT01604772|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: 150 mg given PO"
189076|NCT01604772|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: 150 mg given PO"
189077|NCT01604772|O1|Outcome|Treatment (Akt Inhibitor MK2206)|
189078|NCT01604772|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: 150 mg given PO"
189079|NCT01604408|B3|Baseline|Total|Total of all reporting groups
189080|NCT01604408|B2|Baseline|Placebo|Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.
189081|NCT01604408|B1|Baseline|LY2495655|Participants received a 315-mg dose of LY2495655, administered SC, Q4W for 20 weeks.
189082|NCT01604408|P2|Participant Flow|Placebo|Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.
189083|NCT01604408|P1|Participant Flow|LY2495655|Participants received a 315-milligram (mg) dose of LY2495655, administered subcutaneously (SC), every 4 weeks (Q4W) for 20 weeks.
189084|NCT01604408|O2|Outcome|Placebo|Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.
189085|NCT01604408|O1|Outcome|LY2495655|Participants received a 315-mg dose of LY2495655, administered SC, Q4W for 20 weeks.
189086|NCT01604408|O2|Outcome|Placebo|Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.
189087|NCT01604408|O1|Outcome|LY2495655|Participants received a 315-mg dose of LY2495655, administered SC, Q4W for 20 weeks.
189089|NCT01604408|O1|Outcome|LY2495655|Participants received a 315-mg dose of LY2495655, administered SC, Q4W for 20 weeks.
189090|NCT01604408|O2|Outcome|Placebo|Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.
189091|NCT01604408|O1|Outcome|LY2495655|Participants received a 315-mg dose of LY2495655, administered SC, Q4W for 20 weeks.
189092|NCT01604408|E2|Reported Event|Placebo|Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.
189093|NCT01604408|E1|Reported Event|LY2495655|Participants received a 315-mg dose of LY2495655, administered SC, Q4W for 20 weeks.
189094|NCT01604343|B4|Baseline|Total|Total of all reporting groups
189095|NCT01604343|B3|Baseline|Sirukumab 100 mg q2w|All participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189096|NCT01604343|B2|Baseline|Sirukumab 50 mg q4w|All participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189097|NCT01604343|B1|Baseline|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189098|NCT01604343|P5|Participant Flow|Sirukumab 100 mg q2w|All participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189099|NCT01604343|P4|Participant Flow|Placebo to 100 mg q2w Due to EE/LE/CO|Participants who were assigned to placebo group and who met EE at Week 18 or LE at Week 40 or CO at Week 52 were re-randomized to receive subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189100|NCT01604343|P3|Participant Flow|Sirukumab 50 mg q4w|All participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189101|NCT01604343|P2|Participant Flow|Placebo to 50 mg q4w Due to EE/LE/CO|Participants who were assigned to placebo group and who met EE at Week 18 or LE at Week 40 or CO at Week 52 were re-randomized to receive subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189102|NCT01604343|P1|Participant Flow|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week (W) 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189103|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189104|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189105|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189106|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189107|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189108|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189109|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189110|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189111|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189112|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189113|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189397|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189114|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189115|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189116|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189117|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189118|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189119|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189120|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189121|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189122|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189123|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189124|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189125|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189126|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189127|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189128|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189129|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189130|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189131|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189132|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189133|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189134|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189135|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189136|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189137|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189245|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
189246|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
189138|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189139|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189140|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189141|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189142|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189143|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189144|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189145|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189146|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189147|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189148|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189149|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189150|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189151|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189152|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189153|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189154|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189155|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189156|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189157|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189158|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189159|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189160|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189161|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189247|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
189248|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
189162|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189163|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189164|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189165|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189166|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189167|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189168|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189169|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189170|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189171|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189172|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189173|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189174|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189175|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189176|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189177|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189178|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189179|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189180|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189181|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189182|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189183|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189184|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189185|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189249|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
189250|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
189186|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189187|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189188|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189189|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189190|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189191|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189192|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189193|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189194|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189195|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189196|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189197|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189198|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189199|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189200|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189201|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189202|NCT01604343|O3|Outcome|Sirukumab 100 mg|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2, and q2w through Week 104.
189203|NCT01604343|O2|Outcome|Sirukumab 50 mg|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 104 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through Week 104.
189204|NCT01604343|O1|Outcome|Placebo|Participants received Placebo subcutaneously (SC) every 2 weeks (q2w) from Week 0 up to Week 50. Participants who met early escape (EE) criteria at Week 18, or late escape (LE) at Week 40, or cross-over (CO) at Week 52 were rerandomized to receive sirukumab 50 or 100 mg through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189205|NCT01604343|E5|Reported Event|W0 to W120-Sirukumab 100 mg q2w|Participants received 100 mg of sirukumab SC injections at Weeks 0, 2 and q2w throught Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189206|NCT01604343|E4|Reported Event|W0 to W120- Placebo to Sirukumab 100 mg q2w Due to EE/LE or CO|Participants who received placebo in the placebo controlled period were rerandomized (due to EE at Week 18 or LE at Week 40 or CO at Week 52) to receive subcutaneous (SC) sirukumab 100 mg q2w dose up to Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189207|NCT01604343|E3|Reported Event|W0 to W120- Sirukumab 50 mg q4w|Participants received 50 mg of sirukumab SC injections at Weeks 0, 4, and q4w through Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189208|NCT01604343|E2|Reported Event|W0 to W120-Placebo to Sirukumab 50 mg q4w Due to EE/LE or CO|Participants who received placebo in the placebo controlled period were rerandomized (due to EE at Week 18 or LE at Week 40 or CO at Week 52) to receive subcutaneous (SC) sirukumab 50 mg q4w dose regimen up to Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189209|NCT01604343|E1|Reported Event|Week 0 to Week 120-Placebo|Participants received matching placebo from week 0 to week 50, every 2 weeks (q2w) until either early escape (EE) at Week 18 or late escape (LE) at Week 40 or crossover (CO) at Week 52 and were rerandomized to subcutaneous (SC) sirukumab 50 mg q4w or sirukumab 100 mg q2w dose regimens up to Week 104. Participants who completed study agent administration up to Week 104 and did not elect for long term extension (LTE) were followed up for safety from Week 104 up to Week 120.
189210|NCT01604278|B3|Baseline|Total|Total of all reporting groups
189211|NCT01604278|B2|Baseline|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
189212|NCT01604278|B1|Baseline|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
189213|NCT01604278|P2|Participant Flow|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
189214|NCT01604278|P1|Participant Flow|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
189215|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
189216|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
189217|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
189218|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
189219|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
189220|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
189221|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
189222|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
189223|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
189224|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
189225|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
189226|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
189227|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
189228|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
189229|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
189230|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
189231|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
189232|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
189233|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
189234|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
189235|NCT01604278|E2|Reported Event|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
189236|NCT01604278|E1|Reported Event|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
189237|NCT01604265|B3|Baseline|Total|Total of all reporting groups
189238|NCT01604265|B2|Baseline|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
189239|NCT01604265|B1|Baseline|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
189240|NCT01604265|P2|Participant Flow|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
189241|NCT01604265|P1|Participant Flow|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
189242|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
189243|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
189244|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
189251|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
189252|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
189253|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
189254|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
189255|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
189256|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
189257|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
189258|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
189259|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
189260|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
189261|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
189262|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
189263|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
189264|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
189265|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
189266|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
189267|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
189268|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
189269|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
189270|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
189271|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
189272|NCT01604265|E2|Reported Event|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
189273|NCT01604265|E1|Reported Event|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
189274|NCT01604122|B3|Baseline|Total|Total of all reporting groups
189275|NCT01604122|B2|Baseline|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
189276|NCT01604122|B1|Baseline|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189277|NCT01604122|P2|Participant Flow|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
189278|NCT01604122|P1|Participant Flow|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189279|NCT01604122|O1|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
189280|NCT01604122|O1|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
189281|NCT01604122|O1|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
189282|NCT01604122|O1|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
189283|NCT01604122|O1|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
189284|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189285|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189286|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189287|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189288|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189289|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189290|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189291|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
189292|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189293|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
189294|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189295|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
189296|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189297|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
189298|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189299|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
189300|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189301|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
189302|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189303|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
189304|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189305|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
189306|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189307|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
189308|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189309|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
189310|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189311|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
189312|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189313|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189314|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189315|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189316|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189317|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189318|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
189319|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189320|NCT01604122|E2|Reported Event|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
189321|NCT01604122|E1|Reported Event|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
189322|NCT01604109|B3|Baseline|Total|Total of all reporting groups
189323|NCT01604109|B2|Baseline|Placebo Control Paste|"the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate~the paste without CPP-ACP : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch."
189324|NCT01604109|B1|Baseline|Tooth Mousse|"10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste~10 % w/v CPP-ACP paste : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch"
189325|NCT01604109|P2|Participant Flow|Placebo Control Paste|"the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate~the paste without CPP-ACP : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch."
189326|NCT01604109|P1|Participant Flow|Tooth Mousse|"10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste~10 % w/v CPP-ACP paste : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch"
189327|NCT01604109|O2|Outcome|Placebo Control Paste|"the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate~the paste without CPP-ACP : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch."
189328|NCT01604109|O1|Outcome|Tooth Mousse|"10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste~10 % w/v CPP-ACP paste : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch"
189329|NCT01604109|E2|Reported Event|Placebo Control Paste|"the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate~the paste without CPP-ACP : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch."
189330|NCT01604109|E1|Reported Event|Tooth Mousse|"10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste~10 % w/v CPP-ACP paste : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch"
189331|NCT01603940|B3|Baseline|Total|Total of all reporting groups
189332|NCT01603940|B2|Baseline|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
189333|NCT01603940|B1|Baseline|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
189334|NCT01603940|P2|Participant Flow|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
189335|NCT01603940|P1|Participant Flow|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
189336|NCT01603940|O2|Outcome|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
189337|NCT01603940|O1|Outcome|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
189338|NCT01603940|O2|Outcome|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
189339|NCT01603940|O1|Outcome|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
189340|NCT01603940|O2|Outcome|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
189341|NCT01603940|O1|Outcome|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
189342|NCT01603940|O2|Outcome|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
189343|NCT01603940|O1|Outcome|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
189344|NCT01603940|O2|Outcome|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
189345|NCT01603940|O1|Outcome|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
189346|NCT01603940|E2|Reported Event|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
189347|NCT01603940|E1|Reported Event|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
189348|NCT01603875|B4|Baseline|Total|Total of all reporting groups
189349|NCT01603875|B3|Baseline|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
189350|NCT01603875|B2|Baseline|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
189351|NCT01603875|B1|Baseline|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
189352|NCT01603875|P3|Participant Flow|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
189353|NCT01603875|P2|Participant Flow|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
189354|NCT01603875|P1|Participant Flow|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
189355|NCT01603875|O3|Outcome|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
189356|NCT01603875|O2|Outcome|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
189357|NCT01603875|O1|Outcome|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
189358|NCT01603875|O3|Outcome|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
189359|NCT01603875|O2|Outcome|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
189360|NCT01603875|O1|Outcome|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
189361|NCT01603875|O3|Outcome|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
189362|NCT01603875|O2|Outcome|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
189363|NCT01603875|O1|Outcome|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
189364|NCT01603875|O3|Outcome|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
189365|NCT01603875|O2|Outcome|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
189366|NCT01603875|O1|Outcome|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
189396|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189367|NCT01603875|O3|Outcome|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
189368|NCT01603875|O2|Outcome|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
189369|NCT01603875|O1|Outcome|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
189370|NCT01603875|E3|Reported Event|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
189371|NCT01603875|E2|Reported Event|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
189372|NCT01603875|E1|Reported Event|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
189373|NCT01603459|B1|Baseline|IncobotulinumtoxinA (Xeomin) (up to 800 Units)|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA: Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units.~For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: Intramuscular injection."
189374|NCT01603459|P1|Participant Flow|IncobotulinumtoxinA (Xeomin) (up to 800 Units)|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA: Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units.~For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: Intramuscular injection."
189375|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189376|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189377|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189378|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189379|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189380|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189381|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189382|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189383|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189384|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to Cycle 3 Control Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189385|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 2 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189386|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 1 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189387|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189388|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189389|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189390|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189391|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189392|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189393|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189394|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189395|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189597|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189398|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189399|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189400|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189401|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189402|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189403|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189404|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189405|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189406|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189407|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189408|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189409|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189410|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189411|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189412|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189413|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189414|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189415|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189416|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189417|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to Cycle 3 Control Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189418|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 2 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189419|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 1 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189420|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189421|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189422|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189423|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189424|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189425|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189426|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189427|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189428|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189429|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189430|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189431|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189432|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189433|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189603|NCT01603043|B1|Baseline|AL-78898A|1 intravitreal injection per month for up to 12 months
189434|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189435|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to Cycle 3 Control Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189436|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 2 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189437|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 1 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189438|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189439|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189440|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189441|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189442|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189443|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189444|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189445|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189446|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189447|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189448|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189449|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189450|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to Cycle 3 Control Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189451|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 2 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189452|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 1 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189453|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189454|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189455|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189456|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189457|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189458|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189459|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189460|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189461|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189462|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189463|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189464|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189465|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to Cycle 3 Control Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189466|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 2 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189467|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 1 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
194325|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
189468|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189469|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189470|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189471|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189472|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189473|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189474|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189475|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189476|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189477|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189478|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189479|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Timeframe 1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189480|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to Cycle 3 Control Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189481|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 2 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189482|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 1 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189483|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189484|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189485|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189486|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189487|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
189488|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189489|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
189490|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189491|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
189492|NCT01603459|E1|Reported Event|IncobotulinumtoxinA (Xeomin) (up to 800 Units)|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA: Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units.~For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: Intramuscular injection."
189493|NCT01603420|B3|Baseline|Total|Total of all reporting groups
189494|NCT01603420|B2|Baseline|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189495|NCT01603420|B1|Baseline|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189496|NCT01603420|P2|Participant Flow|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189497|NCT01603420|P1|Participant Flow|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189598|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
194326|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
189498|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189499|NCT01603420|O1|Outcome|Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH)|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189500|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189501|NCT01603420|O1|Outcome|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189502|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189503|NCT01603420|O1|Outcome|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189504|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189505|NCT01603420|O1|Outcome|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189506|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189507|NCT01603420|O1|Outcome|Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH)|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189508|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189509|NCT01603420|O1|Outcome|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189510|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189511|NCT01603420|O1|Outcome|Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH)|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189512|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189513|NCT01603420|O1|Outcome|Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH)|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189514|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189599|NCT01603056|E2|Reported Event|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189515|NCT01603420|O1|Outcome|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189516|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189517|NCT01603420|O1|Outcome|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189518|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189519|NCT01603420|O1|Outcome|Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH)|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189520|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189521|NCT01603420|O1|Outcome|Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH)|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189522|NCT01603420|E2|Reported Event|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189523|NCT01603420|E1|Reported Event|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
189524|NCT01603394|B1|Baseline|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
189525|NCT01603394|P1|Participant Flow|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
189526|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
189527|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
189528|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
189529|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
189530|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
189531|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
189600|NCT01603056|E1|Reported Event|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189601|NCT01603043|B3|Baseline|Total|Total of all reporting groups
194327|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
189532|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
189533|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
189534|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
189535|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
189536|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
189537|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
189538|NCT01603394|E1|Reported Event|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
189539|NCT01603277|B3|Baseline|Total|Total of all reporting groups
189540|NCT01603277|B2|Baseline|Normal Saline|Placebo: Normal Saline
189541|NCT01603277|B1|Baseline|Anti-GM-CSF Monoclonal Antibody 400mg|Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg
189542|NCT01603277|P2|Participant Flow|Normal Saline|Placebo: Normal Saline
189543|NCT01603277|P1|Participant Flow|Anti-GM-CSF Monoclonal Antibody 400mg|Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg
189544|NCT01603277|O2|Outcome|Normal Saline|Placebo: Normal Saline
189545|NCT01603277|O1|Outcome|Anti-GM-CSF Monoclonal Antibody 400mg|Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg
189546|NCT01603277|E2|Reported Event|Normal Saline|Placebo: Normal Saline
189547|NCT01603277|E1|Reported Event|Anti-GM-CSF Monoclonal Antibody 400mg|Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg
189548|NCT01603121|B1|Baseline|All Study Participants|Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart.
189549|NCT01603121|P2|Participant Flow|Lisofylline Intravenous First, Then Lisofylline Subcutaneous|"Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
189550|NCT01603121|P1|Participant Flow|Lisofylline Subcutaneous First, Then Lisofylline Intravenous|"Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
189551|NCT01603121|O2|Outcome|Lisofylline Intravenous|"Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
189552|NCT01603121|O1|Outcome|Lisofylline Subcutaneous|"Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
189553|NCT01603121|O2|Outcome|Lisofylline Intravenous|"Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
189554|NCT01603121|O1|Outcome|Lisofylline Subcutaneous|"Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
189555|NCT01603121|O2|Outcome|Lisofylline Intravenous|"Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
189556|NCT01603121|O1|Outcome|Lisofylline Subcutaneous|"Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
189557|NCT01603121|E2|Reported Event|Lisofylline Intravenous|"Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
189558|NCT01603121|E1|Reported Event|Lisofylline Subcutaneous|"Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
189559|NCT01603082|B3|Baseline|Total|Total of all reporting groups
189560|NCT01603082|B2|Baseline|Clopidogrel|600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
189561|NCT01603082|B1|Baseline|Ticagrelor|180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
189562|NCT01603082|P2|Participant Flow|Clopidogrel|600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
189563|NCT01603082|P1|Participant Flow|Ticagrelor|180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
189564|NCT01603082|O2|Outcome|Clopidogrel|600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
189565|NCT01603082|O1|Outcome|Ticagrelor|180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
189566|NCT01603082|O2|Outcome|Clopidogrel|600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
189567|NCT01603082|O1|Outcome|Ticagrelor|180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
189568|NCT01603082|E2|Reported Event|Clopidogrel|600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
189569|NCT01603082|E1|Reported Event|Ticagrelor|180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
189570|NCT01603056|B3|Baseline|Total|Total of all reporting groups
189571|NCT01603056|B2|Baseline|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189572|NCT01603056|B1|Baseline|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189573|NCT01603056|P2|Participant Flow|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189574|NCT01603056|P1|Participant Flow|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189575|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189576|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189577|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189578|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189579|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189580|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189581|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189582|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189583|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189584|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189585|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189586|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189587|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189588|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189589|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189590|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189591|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189592|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189593|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189594|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189595|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189596|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
189604|NCT01603043|P2|Participant Flow|Sham Injection|1 mock injection per month for 12 months
189605|NCT01603043|P1|Participant Flow|AL-78898A|1 intravitreal injection per month for up to 12 months
189606|NCT01603043|O2|Outcome|Sham Injection|1 mock injection per month for 12 months
189607|NCT01603043|O1|Outcome|AL-78898A|1 intravitreal injection per month for up to 12 months
189608|NCT01603043|O2|Outcome|Sham Injection|1 mock injection per month for 12 months
189609|NCT01603043|O1|Outcome|AL-78898A|1 intravitreal injection per month for up to 12 months
189610|NCT01603043|O2|Outcome|Sham Injection|1 mock injection per month for 12 months
189611|NCT01603043|O1|Outcome|AL-78898A|1 intravitreal injection per month for up to 12 months
189612|NCT01603043|E2|Reported Event|Sham Injection|1 mock injection per month for 12 months
189613|NCT01603043|E1|Reported Event|AL-78898A|1 intravitreal injection per month for up to 12 months
189614|NCT01602965|B3|Baseline|Total|Total of all reporting groups
189615|NCT01602965|B2|Baseline|Self Help Informative Booklet|"Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies.~Self Help Informative Booklet: Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies"
189616|NCT01602965|B1|Baseline|Counseling Monthly Phone Calls|"the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviours that need to be changed, problem-solving as to how to make the changes and physical activity levels.~Counseling Monthly Phone Calls: the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviors that need to be changed, problem-solving as to how to make the changes and physical activity levels."
189617|NCT01602965|P2|Participant Flow|Self Help Informative Booklet|"Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies.~Self Help Informative Booklet: Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies"
189618|NCT01602965|P1|Participant Flow|Counseling Monthly Phone Calls|"the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviours that need to be changed, problem-solving as to how to make the changes and physical activity levels.~Counseling Monthly Phone Calls: the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviors that need to be changed, problem-solving as to how to make the changes and physical activity levels."
189619|NCT01602965|O2|Outcome|Self Help Informative Booklet|"Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies.~Self Help Informative Booklet: Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies"
189620|NCT01602965|O1|Outcome|Counseling Monthly Phone Calls|"the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviours that need to be changed, problem-solving as to how to make the changes and physical activity levels.~Counseling Monthly Phone Calls: the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviors that need to be changed, problem-solving as to how to make the changes and physical activity levels."
189621|NCT01602965|E2|Reported Event|Self Help Informative Booklet|"Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies.~Self Help Informative Booklet: Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies"
189622|NCT01602965|E1|Reported Event|Counseling Monthly Phone Calls|"the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviours that need to be changed, problem-solving as to how to make the changes and physical activity levels.~Counseling Monthly Phone Calls: the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviors that need to be changed, problem-solving as to how to make the changes and physical activity levels."
189623|NCT01602744|B3|Baseline|Total|Total of all reporting groups
189624|NCT01602744|B2|Baseline|Intervention STOPP/START|Screening medications with STOPP/START critera
189625|NCT01602744|B1|Baseline|Controll|The medications in this arm will not be screened.
189626|NCT01602744|P2|Participant Flow|Intervention STOPP/START|Screening medications with STOPP/START critera
189627|NCT01602744|P1|Participant Flow|Controll|The medications in this arm will not be screened.
189628|NCT01602744|O2|Outcome|Intervention STOPP/START|Screening medications with STOPP/START critera
189629|NCT01602744|O1|Outcome|Controll|The medications in this arm will not be screened.
189630|NCT01602744|O2|Outcome|Intervention STOPP/START|Screening medications with STOPP/START critera
189631|NCT01602744|O1|Outcome|Controll|The medications in this arm will not be screened.
189632|NCT01602744|O2|Outcome|Intervention STOPP/START|Screening medications with STOPP/START critera
189633|NCT01602744|O1|Outcome|Controll|The medications in this arm will not be screened.
189634|NCT01602744|O2|Outcome|Intervention STOPP/START|Screening medications with STOPP/START critera
189635|NCT01602744|O1|Outcome|Controll|The medications in this arm will not be screened.
189636|NCT01602744|O2|Outcome|Intervention STOPP/START|Screening medications with STOPP/START critera
189637|NCT01602744|O1|Outcome|Controll|The medications in this arm will not be screened.
189638|NCT01602744|O2|Outcome|Intervention STOPP/START|Screening medications with STOPP/START critera
189639|NCT01602744|O1|Outcome|Controll|The medications in this arm will not be screened.
189640|NCT01602744|E2|Reported Event|Intervention STOPP/START|Screening medications with STOPP/START critera
189641|NCT01602744|E1|Reported Event|Controll|The medications in this arm will not be screened.
189642|NCT01602731|B1|Baseline|AMDD|"Subjects with <88% medication adherence, determined by 30-day pillcount, will proceed to AMDD portion of study~Automated Medication Dispensing Device: A pre-filled medication dispensing machine with a safety phone call if doses are missed"
189643|NCT01602731|P1|Participant Flow|Automated Medication Dispensing Device|"Subjects with <88% medication adherence, determined by 30-day pillcount, will proceed to AMDD portion of study~Automated Medication Dispensing Device: A pre-filled medication dispensing machine with a safety phone call if doses are missed"
189644|NCT01602731|O1|Outcome|Automated Medication Dispensing Device|"Subjects with <88% medication adherence, determined by 30-day pillcount, will proceed to AMDD portion of study~Automated Medication Dispensing Device: A pre-filled medication dispensing machine with a safety phone call if doses are missed"
189645|NCT01602731|O2|Outcome|After AMDD|Adherence was measured with the use of the AMDD as a 30-day pill count
189646|NCT01602731|O1|Outcome|Before AMDD|Adherence was measured by 30-day pill count before the use of AMDD
189647|NCT01602731|E1|Reported Event|AMDD|"Subjects with <88% medication adherence, determined by 30-day pillcount, will proceed to AMDD portion of study~Automated Medication Dispensing Device: A pre-filled medication dispensing machine with a safety phone call if doses are missed"
189648|NCT01602562|B3|Baseline|Total|Total of all reporting groups
189649|NCT01602562|B2|Baseline|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189650|NCT01602562|B1|Baseline|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189651|NCT01602562|P2|Participant Flow|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kilogram (kg) body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189652|NCT01602562|P1|Participant Flow|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a valaciclovir hydrochloride (VACV) tablet containing 500 milligrams (mg) of valaciclovir orally twice daily for 43 days, from 7 days before hematopoietic stem cell transplantation (HSCT) to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189653|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189654|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189655|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189656|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189657|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189658|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189659|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189702|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189660|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189661|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189662|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189663|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189664|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189665|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189666|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189667|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189668|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189669|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189670|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189671|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189672|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189673|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and & <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189674|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189701|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
194328|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
189675|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189676|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189677|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189678|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189679|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189680|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189681|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189682|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189683|NCT01602562|E2|Reported Event|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189684|NCT01602562|E1|Reported Event|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
189685|NCT01602549|B3|Baseline|Total|Total of all reporting groups
189686|NCT01602549|B2|Baseline|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
189687|NCT01602549|B1|Baseline|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189688|NCT01602549|P2|Participant Flow|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
189689|NCT01602549|P1|Participant Flow|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189690|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189691|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189692|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189693|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189694|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189695|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189696|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189697|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189698|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
189699|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189700|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
190502|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
189703|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189704|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
189705|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189706|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189707|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
189708|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189709|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189710|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
189711|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189712|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189713|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
189714|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189715|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189716|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
189717|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189718|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189719|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
189720|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189721|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189722|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
189723|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189724|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189725|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
189726|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189727|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189728|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
189729|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189730|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189731|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
189732|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189733|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189734|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
189735|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189736|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189737|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
189738|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189739|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189740|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189741|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189742|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189743|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189744|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189745|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189746|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189747|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189748|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189749|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189750|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189751|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189752|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189753|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189754|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189755|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189756|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189757|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189758|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189759|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189760|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189761|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189762|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189763|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189764|NCT01602549|E3|Reported Event|GSK962040 125 mg|Participants received GSK962040 125 milligrams (mg) administered orally once daily for 7 to 9 days.
189765|NCT01602549|E2|Reported Event|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
189766|NCT01602549|E1|Reported Event|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
189767|NCT01602510|B1|Baseline|Open Label Lamotrigine 200 mg/Day|Participants (Par.) received lamotrigine escalated to a target dose of lamotrigine 200 mg/day monotherapy for 6 weeks to 16 weeks. If needed, concomitant psychotropic medications were permitted during this phase however medications were discontinued at least 1 week before entering into the double-blind phase.
189768|NCT01602510|P3|Participant Flow|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
189769|NCT01602510|P2|Participant Flow|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
189770|NCT01602510|P1|Participant Flow|Open Label Lamotrigine 200 mg/Day|Participants (Par.) received lamotrigine escalated to a target dose of lamotrigine 200mg/day monotherapy for 6 weeks to 16 weeks. If needed, concomitant psychotropic medications were permitted during this phase however medications were discontinued at least 1 week before entering into the double-blind phase.
189771|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
189772|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
189773|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
189774|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
189775|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
189776|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
189777|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
189778|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
189779|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
189780|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
189781|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
189782|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
189783|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
189784|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
189785|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
189786|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
189787|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
189788|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
189789|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
189790|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
189791|NCT01602510|E2|Reported Event|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
189792|NCT01602510|E1|Reported Event|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
189793|NCT01602484|B3|Baseline|Total|Total of all reporting groups
189794|NCT01602484|B2|Baseline|Bulk Supplies|Group of post-op patients who have splint applied from bulk supplies
189795|NCT01602484|B1|Baseline|Splint Pack|Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
189796|NCT01602484|P2|Participant Flow|Bulk Supplies|Group of post-op patients who have splint applied from bulk supplies
189797|NCT01602484|P1|Participant Flow|Splint Pack|Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
189798|NCT01602484|O2|Outcome|Bulk Supplies|Group of post-op patients who have splint applied from bulk supplies
189799|NCT01602484|O1|Outcome|Splint Pack|Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
189800|NCT01602484|O2|Outcome|Bulk Supplies|Group of post-op patients who have splint applied from bulk supplies
189801|NCT01602484|O1|Outcome|Splint Pack|Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
189802|NCT01602484|O2|Outcome|Bulk Supplies|Group of post-op patients who have splint applied from bulk supplies
189803|NCT01602484|O1|Outcome|Splint Pack|Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
189804|NCT01602484|O2|Outcome|Bulk Supplies|Group of post-op patients who have splint applied from bulk supplies
189805|NCT01602484|O1|Outcome|Splint Pack|Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
189806|NCT01602484|E2|Reported Event|Bulk Supplies|Group of post-op patients who have splint applied from bulk supplies
189807|NCT01602484|E1|Reported Event|Splint Pack|Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
189808|NCT01602471|B1|Baseline|[F-18]RDG-K5|[F-18]RDG-K5 was administred and PET scan performed
189809|NCT01602471|P1|Participant Flow|[F-18]RDG-K5|[F-18]RDG-K5 was administred and PET scan performed
189810|NCT01602471|O1|Outcome|[F-18]RDG-K5|[F-18]RDG-K5 was administred and PET scan performed
189811|NCT01602471|E1|Reported Event|[F-18]RDG-K5|[F-18]RDG-K5 was administred and PET scan performed
189812|NCT01602380|B3|Baseline|Total|Total of all reporting groups
189813|NCT01602380|B2|Baseline|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
189814|NCT01602380|B1|Baseline|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
189815|NCT01602380|P2|Participant Flow|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
189816|NCT01602380|P1|Participant Flow|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
189817|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
189818|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
189819|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
189820|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
189821|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
189822|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
189823|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
189824|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
189825|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
189826|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
189827|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
189828|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
189829|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
189830|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
189831|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
189832|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
189833|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
189834|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
189835|NCT01602380|E2|Reported Event|Anastrozole 1 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
189836|NCT01602380|E1|Reported Event|Fulvestrant 500 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
189837|NCT01602341|B3|Baseline|Total|Total of all reporting groups
189838|NCT01602341|B2|Baseline|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189839|NCT01602341|B1|Baseline|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189840|NCT01602341|P2|Participant Flow|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189841|NCT01602341|P1|Participant Flow|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate atopic dermatitis (AD), once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189842|NCT01602341|O4|Outcome|AN2728 Ointment 2 Percent, Twice Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189843|NCT01602341|O3|Outcome|AN2728 Ointment 0.5 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189898|NCT01602315|O4|Outcome|Arm C - BYL719+Cetuximab, Dispersible Tablets|300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
189844|NCT01602341|O2|Outcome|AN2728 Ointment 2 Percent, Once Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189845|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent, Once Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189846|NCT01602341|O2|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189847|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189848|NCT01602341|O2|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189849|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189850|NCT01602341|O2|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189851|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189852|NCT01602341|O2|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189853|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189854|NCT01602341|O2|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189855|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189856|NCT01602341|O4|Outcome|AN2728 Ointment 2 Percent, Twice Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189857|NCT01602341|O3|Outcome|AN2728 Ointment 0.5 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189858|NCT01602341|O2|Outcome|AN2728 Ointment 2 Percent, Once Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189859|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent, Once Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189860|NCT01602341|O4|Outcome|AN2728 Ointment 2 Percent, Twice Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189861|NCT01602341|O3|Outcome|AN2728 Ointment 0.5 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189862|NCT01602341|O2|Outcome|AN2728 Ointment 2 Percent, Once Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189863|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent, Once Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189864|NCT01602341|O4|Outcome|AN2728 Ointment 2 Percent, Twice Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189899|NCT01602315|O3|Outcome|Arm B - BYL719 + Cetuximab, Oral Suspension|300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
189865|NCT01602341|O3|Outcome|AN2728 Ointment 0.5 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189866|NCT01602341|O2|Outcome|AN2728 Ointment 2 Percent, Once Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189867|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent, Once Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189868|NCT01602341|O4|Outcome|AN2728 Ointment 2 Percent, Twice Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189869|NCT01602341|O3|Outcome|AN2728 Ointment 0.5 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189870|NCT01602341|O2|Outcome|AN2728 Ointment 2 Percent, Once Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189871|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent, Once Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189872|NCT01602341|E2|Reported Event|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189873|NCT01602341|E1|Reported Event|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
189874|NCT01602315|B8|Baseline|Total|Total of all reporting groups
189875|NCT01602315|B7|Baseline|Arm 3 - BYL719+Cetuximab (Non-randomized)|300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
189876|NCT01602315|B6|Baseline|Arm 2 - Monotherapy Cetuximab (Randomized)|Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
189877|NCT01602315|B5|Baseline|Arm 1 - BYL719+Cetuximab (Randomized)|300mg BYL719 with cetuxumab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
189878|NCT01602315|B4|Baseline|Arm C - BYL719+Cetuximab, Dispersible Tablets|300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
189879|NCT01602315|B3|Baseline|Arm B - BYL719 + Cetuximab, Oral Suspension|300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
189880|NCT01602315|B2|Baseline|Arm A - 400mg BYL719+Cetuximab|400 mg BYL719 as FC whole tablets with cetuximab
189881|NCT01602315|B1|Baseline|Arm A - 300mg BYL719+Cetuximab|300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
189882|NCT01602315|P7|Participant Flow|Arm 3 - BYL719+Cetuximab (Non-randomized)|300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
189883|NCT01602315|P6|Participant Flow|Arm 2 - Monotherapy Cetuximab (Randomized)|Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
189884|NCT01602315|P5|Participant Flow|Arm 1 - BYL719+Cetuximab (Randomized)|300mg BYL719 with cetuxumab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
189885|NCT01602315|P4|Participant Flow|Arm C - BYL719+Cetuximab, Dispersible Tablets|300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
189886|NCT01602315|P3|Participant Flow|Arm B - BYL719 + Cetuximab, Oral Suspension|300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
189887|NCT01602315|P2|Participant Flow|Arm A - 400mg BYL719+Cetuximab|400 mg BYL719 as FC whole tablets with cetuximab
189888|NCT01602315|P1|Participant Flow|Arm A - 300mg BYL719+Cetuximab|300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
189889|NCT01602315|O3|Outcome|BYL719=Cetuximab (Non-randomized)|300mg BYL719with cetuximab in patients resistant to platinum-based therapy and cetuximab in Phase II
189890|NCT01602315|O2|Outcome|Monotherapy Cetuximab (Randomized)|Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
189891|NCT01602315|O1|Outcome|BYL719+ Cetuximab (Randomized)|300mg BYL719 with cetuximab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
189892|NCT01602315|O3|Outcome|Arm 2B - BYL719+Cetuximab|300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
189893|NCT01602315|O2|Outcome|Arm 2 - Monotherapy Cetuximab (Randomized)|Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
189894|NCT01602315|O1|Outcome|Arm 1 - BYL719+Cetuximab (Randomized)|300mg BYL719 with cetuxumab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
189895|NCT01602315|O3|Outcome|Arm 2B - BYL719+Cetuximab|300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
189896|NCT01602315|O2|Outcome|Arm 2 - Monotherapy Cetuximab (Randomized)|Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
189897|NCT01602315|O1|Outcome|Arm 1 - BYL719+Cetuximab (Randomized)|300mg BYL719 with cetuxumab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
190503|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
189900|NCT01602315|O2|Outcome|Arm A - 400mg BYL719+Cetuximab|400 mg BYL719 as FC whole tablets with cetuximab
189901|NCT01602315|O1|Outcome|Arm A - 300mg BYL719+Cetuximab|300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
189902|NCT01602315|O4|Outcome|Arm C - BYL719+Cetuximab, Dispersible Tablets|300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
189903|NCT01602315|O3|Outcome|Arm B - BYL719 + Cetuximab, Oral Suspension|300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
189904|NCT01602315|O2|Outcome|Arm A - 400mg BYL719+Cetuximab|400 mg BYL719 as FC whole tablets with cetuximab
189905|NCT01602315|O1|Outcome|Arm A - 300mg BYL719+Cetuximab|300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
189906|NCT01602315|O3|Outcome|Arm C: BYL719+Cetixumab, Dispersible Tablets|300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
189907|NCT01602315|O2|Outcome|Arm B: BYL719 + Cetuximab, Oral Suspension|300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
189908|NCT01602315|O1|Outcome|Arm A - 300mg BYL719+Cetuximab|300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
189909|NCT01602315|O3|Outcome|Arm C: BYL719+Cetixumab, Dispersible Tablets|300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
189910|NCT01602315|O2|Outcome|Arm B: BYL719 + Cetuximab, Oral Suspension|300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
189911|NCT01602315|O1|Outcome|Arm A - 300mg BYL719+Cetuximab|300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
189912|NCT01602315|O3|Outcome|Arm C: BYL719+Cetixumab, Dispersible Tablets|300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
189913|NCT01602315|O2|Outcome|Arm B: BYL719 + Cetuximab, Oral Suspension|300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
189914|NCT01602315|O1|Outcome|Arm A - 300mg BYL719+Cetuximab|300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
189915|NCT01602315|O4|Outcome|Arm A: 400mg BYL719 + Cetuximab|400 mg BYL719 as FC whole tablets with cetuximab
189916|NCT01602315|O3|Outcome|Arm C: BYL719+Cetixumab, Dispersible Tablets|300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
189917|NCT01602315|O2|Outcome|Arm B: BYL719 + Cetuximab, Oral Suspension|300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
189918|NCT01602315|O1|Outcome|Arm A - 300mg BYL719+Cetuximab|300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
189919|NCT01602315|O4|Outcome|Arm A: 400mg BYL719 + Cetuximab|400 mg BYL719 as FC whole tablets with cetuximab
189920|NCT01602315|O3|Outcome|Arm C: BYL719+Cetixumab, Dispersible Tablets|300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
189921|NCT01602315|O2|Outcome|Arm B: BYL719 + Cetuximab, Oral Suspension|300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
189922|NCT01602315|O1|Outcome|Arm A - 300mg BYL719+Cetuximab|300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
189923|NCT01602315|O4|Outcome|Arm A: 400mg BYL719 + Cetuximab|400 mg BYL719 as FC whole tablets with cetuximab
189924|NCT01602315|O3|Outcome|Arm C: BYL719+Cetixumab, Dispersible Tablets|300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
189925|NCT01602315|O2|Outcome|Arm B: BYL719 + Cetuximab, Oral Suspension|300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
189926|NCT01602315|O1|Outcome|Arm A - 300mg BYL719+Cetuximab|300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
189927|NCT01602315|O1|Outcome|Arm 2B - BYL719+Cetuximab|300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
189928|NCT01602315|O1|Outcome|Arm 2B - BYL719+Cetuximab|300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
189929|NCT01602315|O5|Outcome|All Patients|BYL719 + Cetuximab in Phase II (non-randomized) in patients resistant to or intolerant/ineligible for platinum-based
189930|NCT01602315|O4|Outcome|Arm C - BYL719+Cetuximab, Dispersible Tablets|300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
189931|NCT01602315|O3|Outcome|Arm B - BYL719 + Cetuximab, Oral Suspension|300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
189932|NCT01602315|O2|Outcome|Arm A - 400mg BYL719+Cetuximab|400 mg BYL719 as FC whole tablets with cetuximab
189933|NCT01602315|O1|Outcome|Arm A - 300mg BYL719+Cetuximab|300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
189934|NCT01602315|O1|Outcome|Arm 3 - BYL719+Cetuximab|300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
189935|NCT01602315|O2|Outcome|Arm 2 - Monotherapy Cetuximab (Randomized)|Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
189936|NCT01602315|O1|Outcome|Arm 1 - BYL719+Cetuximab (Randomized)|300mg BYL719 with cetuxumab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
189937|NCT01602315|O1|Outcome|Arm 3 - BYL719+Cetuximab|300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
189938|NCT01602315|O3|Outcome|All Patients (Phase II)|
189939|NCT01602315|O2|Outcome|Arm 2 - Monotherapy Cetuximab (Randomized)|Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
189940|NCT01602315|O1|Outcome|Arm 1 - BYL719+Cetuximab (Randomized)|300mg BYL719 with cetuxumab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
189941|NCT01602315|O1|Outcome|Arm 3 - BYL719+Cetuximab|300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
189942|NCT01602315|O3|Outcome|All Patients|
189943|NCT01602315|O2|Outcome|Arm 2 - Monotherapy Cetuximab (Randomized)|Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
189944|NCT01602315|O1|Outcome|Arm 1 - BYL719+Cetuximab (Randomized)|300mg BYL719 with cetuxumab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
190504|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
189945|NCT01602315|O4|Outcome|Arm C - BYL719+Cetuximab, Dispersible Tablets|300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
189946|NCT01602315|O3|Outcome|Arm B - BYL719 + Cetuximab, Oral Suspension|300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
189947|NCT01602315|O2|Outcome|Arm A - 400mg BYL719+Cetuximab|400 mg BYL719 as FC whole tablets with cetuximab
189948|NCT01602315|O1|Outcome|Arm A - 300mg BYL719+Cetuximab|300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
189949|NCT01602315|O1|Outcome|Arm 2B - BYL719+Cetuximab|300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
189950|NCT01602315|O4|Outcome|Arm B: 300mg BYL719 + Cetuximab|300mg BYL719 in oral suspension with cetuximab
189951|NCT01602315|O3|Outcome|Arm A: 400mg BYL719 + Cetuximab|400 mg BYL719 as FC whole tablets with cetuximab
189952|NCT01602315|O2|Outcome|Arm C: BYL719+Cetixumab, Dispersible Tablets|300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
189953|NCT01602315|O1|Outcome|Arm A - 300mg BYL719+Cetuximab|300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
189954|NCT01602315|O1|Outcome|BYL719+ Cetuximab (Non-randomized)|300mg BYL719 with cetuximab in patients resistant to platinum-based therapy and cetuximab in Phase II
189955|NCT01602315|O2|Outcome|Monotherapy Cetuximab (Randomized)|Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
189956|NCT01602315|O1|Outcome|BYL719+ Cetuximab (Randomized)|300mg BYL719 with cetuximab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
189957|NCT01602315|O5|Outcome|All Patients|All patients in Phase Ib
189958|NCT01602315|O4|Outcome|Arm C - BYL719+Cetuximab, Dispersible Tablets|300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
189959|NCT01602315|O3|Outcome|Arm B - BYL719 + Cetuximab, Oral Suspension|300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
189960|NCT01602315|O2|Outcome|Arm A - 400mg BYL719+Cetuximab|400 mg BYL719 as FC whole tablets with cetuximab
189961|NCT01602315|O1|Outcome|Arm A - 300mg BYL719+Cetuximab|300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
189962|NCT01602315|O1|Outcome|Arm B- 300mg BYL719+Cetuximab|
189963|NCT01602315|O2|Outcome|Arm A - 400mg BYL719+Cetuximab|
189964|NCT01602315|O1|Outcome|Arm A - 300mg BYL719+Cetuximab|
189965|NCT01602315|E8|Reported Event|All Patients|All patients
189966|NCT01602315|E7|Reported Event|Arm 3 - BYL719+Cetuximab (Non-randomized)|300mg BYL719 with cetuximab in Phase II in patients resistant to Platinum-based therapy and cetuximab.
189967|NCT01602315|E6|Reported Event|Arm 2 - Monotherapy Cetuximab (Randomized)|Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy
189968|NCT01602315|E5|Reported Event|Arm 1 - BYL719+Cetuximab (Randomized)|300mg BYL719 with cetuximab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
189969|NCT01602315|E4|Reported Event|Arm C - BYL719+Cetuximab Dispersible Tablets|300mg BYL719 dispersible tablets with cetuximab in patients with swallowing dysfunction administered via G-tube
189970|NCT01602315|E3|Reported Event|Arm B - BYL719 + Cetuximab Oral Suspension|300mg BYL719 as crushed FC tablets with cetuximab in patients with swallowing dysfunction
189971|NCT01602315|E2|Reported Event|Arm A: 400 mg BYL719 + Cetuximab|400 mg BYL719 as FC whole tablets with cetuximab
189972|NCT01602315|E1|Reported Event|Arm A - 300mg BYL719+Cetuximab|300 mg BYL719 as film-coated (FC) whole tablets with cetuximab
189973|NCT01602198|B3|Baseline|Total|Total of all reporting groups
189974|NCT01602198|B2|Baseline|Placebo Transdermal Patch|"Placebo transdermal patch~Placebo patch: Placebo patch 1/day for 6 months"
189975|NCT01602198|B1|Baseline|Exelon Transdermal Patch|"Exelon [rivastigmine] transdermal patch~Exelon [rivastigmine] transdermal patch: Exelon patch 1/day for six months"
189976|NCT01602198|P2|Participant Flow|Placebo Transdermal Patch|"Placebo transdermal patch~Placebo patch: Placebo patch 1/day for 6 months"
189977|NCT01602198|P1|Participant Flow|Exelon Transdermal Patch|"Exelon [rivastigmine] transdermal patch~Exelon [rivastigmine] transdermal patch: Exelon patch 1/day for six months"
189978|NCT01602198|O2|Outcome|Placebo Transdermal Patch|"Placebo transdermal patch~Placebo patch: Placebo patch 1/day for 6 months"
189979|NCT01602198|O1|Outcome|Exelon Transdermal Patch|"Exelon [rivastigmine] transdermal patch~Exelon [rivastigmine] transdermal patch: Exelon patch 1/day for six months"
189980|NCT01602198|E2|Reported Event|Placebo Transdermal Patch|"Placebo transdermal patch~Placebo patch: Placebo patch 1/day for 6 months"
189981|NCT01602198|E1|Reported Event|Exelon Transdermal Patch|"Exelon [rivastigmine] transdermal patch~Exelon [rivastigmine] transdermal patch: Exelon patch 1/day for six months"
189982|NCT01602068|B3|Baseline|Total|Total of all reporting groups
189983|NCT01602068|B2|Baseline|100 mM Sodium Citrate Buffer|Placebo (100 mM sodium citrate buffer solution) delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
189984|NCT01602068|B1|Baseline|Dexamethasone Phosphate Ophthalmic|Dexamethasone Phosphate Ophthalmic: (40 mg/mL) solution delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
189985|NCT01602068|P2|Participant Flow|100 mM Sodium Citrate Buffer|Placebo (100 mM sodium citrate buffer solution) delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
189986|NCT01602068|P1|Participant Flow|Dexamethasone Phosphate Ophthalmic|Dexamethasone Phosphate Ophthalmic: (40 mg/mL) solution delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
189987|NCT01602068|O2|Outcome|100 mM Sodium Citrate Buffer|Placebo (100 mM sodium citrate buffer solution) delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
189988|NCT01602068|O1|Outcome|Dexamethasone Phosphate Ophthalmic|Dexamethasone Phosphate Ophthalmic: (40 mg/mL) solution delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
190505|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190506|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
189989|NCT01602068|E2|Reported Event|100 mM Sodium Citrate Buffer|Placebo (100 mM sodium citrate buffer solution) delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
189990|NCT01602068|E1|Reported Event|Dexamethasone Phosphate Ophthalmic|Dexamethasone Phosphate Ophthalmic: (40 mg/mL) solution delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
189991|NCT01602016|B1|Baseline|All Participants|
189992|NCT01602016|P1|Participant Flow|All Participants|
189993|NCT01602016|O3|Outcome|Phase III: Open Label Extension of Folinic Acid|"If consent for Phase 3 is signed by parents with children who qualify for Phase 3, the research pharmacist will provide a 12 week supply of folinic acid to the parent. This arm will be offered to all clients that completed phase 2 of the trial. After consenting and 12 weeks of folinic acid dosing, the client will come back and complete the same protocol and be tested on the same measures used in phase II of the study. This will be a rolling stopping point so that new therapies can be started, if the parent/caregiver is so inclined~Folinic Acid: capsules of folinic acis will be provided. The target dose will be 1mg/kg/day in two divided doses (0.5mg/kg/dose; 25mg/day maximum) for two weeks followed by 2 mg/kg/day with a maximum dose of 50mg/day provided the lower dose is well tolerated, for 10 weeks."
189994|NCT01602016|O2|Outcome|Phase II: 12 Week Folinic Acid or Placebo Intervention|The child will be consented for Phase 2 (the RCT) and undergo a blood draw (up to 20mL) for metabolic and autoantibody testing. the child will undergo language and behavioral assessment while the parent will be interviewed for the Vineland and other questionnaires (ASQ, RBS-R, SRS, and ABC). Demographic information including; age, race, gender, and ethnicity will be collected. The research pharmacist will randomize the participant to either Intervention A or B (only the research pharmacist will know which intervention has the folinic acid). The research pharmacist will distribute the drug or placebo to the parent and instruct the parent of the proper administration of the intervention. This will be considered the 12 week randomly controlled clinical trial that is investigating the safety and efficacy of folinic acis interventions in ASD and will last for approximately 12 weeks. At the end of 12 weeks, the same assessments that were conducted at baseline will be readministered
189995|NCT01602016|O1|Outcome|Phase I|Baseline Visit Phase 1: The screening portion of the CELF will be administered to the child to screen for language impairment. If a child is determined to be pre-verbal they will automatically qualify,If there is no language impairment, the subject will not be eligible. If language impairment is confirmed, the participant will immediately go on to the baseline visit of Phase 2.
189996|NCT01602016|O1|Outcome|All Participants|
189997|NCT01602016|E1|Reported Event|All Participants|
189998|NCT01601977|B1|Baseline|All Participants|Single arm crossover nonrandomised study
189999|NCT01601977|P1|Participant Flow|All Study Participants|Initial study period in usual care then switched to novel ventilation with AVAPS-AE algorithm
190000|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation~Usual care: usual care~crossover trial, as per intervention"
190001|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study~Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
190002|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation~Usual care: usual care~crossover trial, as per intervention"
190003|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study~Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
190004|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation~Usual care: usual care~crossover trial, as per intervention"
190005|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study~Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
190006|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation~Usual care: usual care~crossover trial, as per intervention"
190007|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study~Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
190008|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation~Usual care: usual care~crossover trial, as per intervention"
190009|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study~Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
190010|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation~Usual care: usual care~crossover trial, as per intervention"
190011|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study~Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
190012|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation~Usual care: usual care~crossover trial, as per intervention"
190013|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study~Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
190014|NCT01601977|E2|Reported Event|Usual Care|"Usual care including non-invasive ventilation~Usual care: usual care"
190015|NCT01601977|E1|Reported Event|Intervention|"Single arm, open labelled study~Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
190016|NCT01601821|B3|Baseline|Total|Total of all reporting groups
190017|NCT01601821|B2|Baseline|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190018|NCT01601821|B1|Baseline|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190232|NCT01601132|O2|Outcome|Theophylline + Colchicine|Theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
190019|NCT01601821|P2|Participant Flow|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190020|NCT01601821|P1|Participant Flow|CsA+Rapamune+CS|Month 0-3: rapamune 6 milligram (mg) tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 nanogram per milliliter (ng/mL) in combination with cyclosporine (CsA) tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, mycophenolate mofetil (MMF) tablet orally at a dose of 1-1.5 grams per day (g/day) and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received corticosteroids (CS) tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190021|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190022|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190023|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190024|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190025|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190026|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190027|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190028|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190029|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190030|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190031|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190060|NCT01601704|O2|Outcome|Placebo|"Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
190233|NCT01601132|O1|Outcome|Theophylline|Theophylline 300 mg, solution, orally, on Day 1.
190507|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190032|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190033|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190034|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190035|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190036|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190037|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190038|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190039|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190040|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190041|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190042|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190043|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190044|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190045|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190046|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190047|NCT01601821|E2|Reported Event|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190048|NCT01601821|E1|Reported Event|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
190049|NCT01601782|B1|Baseline|Volume Imaging Scan|"New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.~Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). : The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to image the muscle and tendon injuries.~Ultrasound Scan : Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician."
190050|NCT01601782|P1|Participant Flow|Volume Imaging Scan|"New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.~Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). : The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to image the muscle and tendon injuries.~Ultrasound Scan : Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician."
190051|NCT01601782|O1|Outcome|Volume Imaging Scan|"New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.~Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). : The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to image the muscle and tendon injuries.~Ultrasound Scan : Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician."
190052|NCT01601782|E1|Reported Event|Volume Imaging Scan|"New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.~Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). : The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to image the muscle and tendon injuries.~Ultrasound Scan : Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician."
190053|NCT01601704|B3|Baseline|Total|Total of all reporting groups
190054|NCT01601704|B2|Baseline|Placebo|"Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
190055|NCT01601704|B1|Baseline|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
190056|NCT01601704|P2|Participant Flow|Placebo|"Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
190057|NCT01601704|P1|Participant Flow|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
190058|NCT01601704|O2|Outcome|Placebo|"Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
190059|NCT01601704|O1|Outcome|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
190083|NCT01601626|O1|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
194329|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
190061|NCT01601704|O1|Outcome|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
190062|NCT01601704|O2|Outcome|Placebo|"Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
190063|NCT01601704|O1|Outcome|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
190064|NCT01601704|O2|Outcome|Placebo|"Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
190065|NCT01601704|O1|Outcome|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
190066|NCT01601704|O2|Outcome|Placebo|"Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
190067|NCT01601704|O1|Outcome|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
190068|NCT01601704|E2|Reported Event|Placebo|"Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
190069|NCT01601704|E1|Reported Event|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
190070|NCT01601691|B1|Baseline|Spacer|"Subjects with spacer injection~DuraSeal: Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate"
190071|NCT01601691|P1|Participant Flow|Spacer|"Subjects with spacer injection~DuraSeal: Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate"
190072|NCT01601691|O1|Outcome|Spacer|"Subjects with spacer injection~DuraSeal: Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate"
190073|NCT01601691|E1|Reported Event|Spacer|"Subjects with spacer injection~DuraSeal: Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate"
190074|NCT01601626|B4|Baseline|Total|Total of all reporting groups
190075|NCT01601626|B3|Baseline|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190076|NCT01601626|B2|Baseline|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190077|NCT01601626|B1|Baseline|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190078|NCT01601626|P3|Participant Flow|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190079|NCT01601626|P2|Participant Flow|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190080|NCT01601626|P1|Participant Flow|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190081|NCT01601626|O3|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190082|NCT01601626|O2|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190084|NCT01601626|O3|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190085|NCT01601626|O2|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190086|NCT01601626|O1|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190087|NCT01601626|O3|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190088|NCT01601626|O2|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190089|NCT01601626|O1|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190090|NCT01601626|O3|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190091|NCT01601626|O2|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190092|NCT01601626|O1|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190093|NCT01601626|O3|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190094|NCT01601626|O2|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190095|NCT01601626|O1|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190096|NCT01601626|O3|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190097|NCT01601626|O2|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190098|NCT01601626|O1|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190099|NCT01601626|O3|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190100|NCT01601626|O2|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190101|NCT01601626|O1|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190102|NCT01601626|O3|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190103|NCT01601626|O2|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190104|NCT01601626|O1|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190105|NCT01601626|O3|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190106|NCT01601626|O2|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190107|NCT01601626|O1|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190229|NCT01601132|O1|Outcome|Theophylline|Theophylline 300 mg, solution, orally, on Day 1.
190340|NCT01600495|O1|Outcome|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm.
190108|NCT01601626|O3|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190109|NCT01601626|O2|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190110|NCT01601626|O1|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190111|NCT01601626|O3|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190112|NCT01601626|O2|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190113|NCT01601626|O1|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190114|NCT01601626|O3|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190115|NCT01601626|O2|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190116|NCT01601626|O1|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190117|NCT01601626|O3|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190118|NCT01601626|O2|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190119|NCT01601626|O1|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190120|NCT01601626|O3|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190121|NCT01601626|O2|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190122|NCT01601626|O1|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190123|NCT01601626|O3|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190124|NCT01601626|O2|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190125|NCT01601626|O1|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190126|NCT01601626|O3|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190127|NCT01601626|O2|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190128|NCT01601626|O1|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190129|NCT01601626|O3|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190130|NCT01601626|O2|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190131|NCT01601626|O1|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190230|NCT01601132|O2|Outcome|Theophylline + Colchicine|Theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
190132|NCT01601626|O3|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190133|NCT01601626|O2|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190134|NCT01601626|O1|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190135|NCT01601626|O3|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190136|NCT01601626|O2|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190137|NCT01601626|O1|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190138|NCT01601626|O3|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190139|NCT01601626|O2|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190140|NCT01601626|O1|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190141|NCT01601626|O3|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190142|NCT01601626|O2|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190143|NCT01601626|O1|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190144|NCT01601626|O3|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190145|NCT01601626|O2|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190146|NCT01601626|O1|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190147|NCT01601626|O3|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190148|NCT01601626|O2|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190149|NCT01601626|O1|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190150|NCT01601626|O3|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190151|NCT01601626|O2|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190152|NCT01601626|O1|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190153|NCT01601626|O3|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190154|NCT01601626|O2|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190155|NCT01601626|O1|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190231|NCT01601132|O1|Outcome|Theophylline|Theophylline 300 mg, solution, orally, on Day 1.
190508|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190509|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190156|NCT01601626|O3|Outcome|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190157|NCT01601626|O2|Outcome|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190158|NCT01601626|O1|Outcome|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190159|NCT01601626|E3|Reported Event|C: Standard-Dose LPV/r + RAL w/RBT|"ART: standard-dose LPV/r twice daily + RAL + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + RAL + two NRTIs."
190160|NCT01601626|E2|Reported Event|B: Double-dose LPV/r w/RIF|"ART: double-dose LPV/r twice daily + 2 NRTIs. Anti-TB therapy: isoniazid, rifampin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + 2 NRTIs."
190161|NCT01601626|E1|Reported Event|A: Standard-dose LPV/r w/RBT|"ART: standard-dose LPV/r twice daily + two NRTIs. Anti-TB therapy: isoniazid, rifabutin, ethambutol, pyrazinamide, and pyridoxine daily.~After completion of TB treatment through week 72: standard-dose LPV/r twice daily + two NRTIs."
190162|NCT01601470|B1|Baseline|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
190163|NCT01601470|P1|Participant Flow|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
190164|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
190165|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
190166|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
190167|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
190168|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
190169|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
190170|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
190171|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
190172|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
190173|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
190174|NCT01601470|E3|Reported Event|Period 3: LCZ696 + Sildenafil|In Period 3, on study Day 8, participants received LCZ696 , co-administered at the same time with a single dose of sildenafil.
190175|NCT01601470|E2|Reported Event|Period 2: LCZ696|In Period 2 (study Days 3-7), participants received LCZ696 once daily.
190176|NCT01601470|E1|Reported Event|Period 1: Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by wash out on Day 2.
190177|NCT01601236|B7|Baseline|Total|Total of all reporting groups
190178|NCT01601236|B6|Baseline|Group 6: Placebo (0.4 mL) Daily|"Placebo~Placebo: Placebo contains the same inactive ingredients as H.P. Acthar Gel without the active pharmaceutical ingredient (API). Placebo is administered via daily SC injection for 36 weeks in equal volumes as the Acthar comparator volumes."
190179|NCT01601236|B5|Baseline|Group 5: Acthar 32 U (0.4 mL) Daily|"Repository Corticotropin Injection~Repository Corticotropin Injection: H.P. Acthar Gel (repository corticotropin injection) is administered via daily SC injection for 36 weeks in the three dose groups [8 U (0.1 mL), 16 U (0.2 mL), or 32 U (0.4 mL)]."
190180|NCT01601236|B4|Baseline|Group 4: Placebo (0.2 mL) Daily|"Placebo~Placebo: Placebo contains the same inactive ingredients as H.P. Acthar Gel without the active pharmaceutical ingredient (API). Placebo is administered via daily SC injection for 36 weeks in equal volumes as the Acthar comparator volumes."
190181|NCT01601236|B3|Baseline|Group 3: Acthar 16 U (0.2 mL) Daily|"Repository Corticotropin Injection~Repository Corticotropin Injection: H.P. Acthar Gel (repository corticotropin injection) is administered via daily SC injection for 36 weeks in the three dose groups [8 U (0.1 mL), 16 U (0.2 mL), or 32 U (0.4 mL)]."
190182|NCT01601236|B2|Baseline|Group 2: Placebo (0.1 mL) Daily|"Placebo~Placebo: Placebo contains the same inactive ingredients as H.P. Acthar Gel without the active pharmaceutical ingredient (API). Placebo is administered via daily SC injection for 36 weeks in equal volumes as the Acthar comparator volumes."
190183|NCT01601236|B1|Baseline|Group 1: Acthar 8 U (0.1 mL) Daily|"Repository Corticotropin Injection~Repository Corticotropin Injection: H.P. Acthar Gel (repository corticotropin injection) is administered via daily SC injection for 36 weeks in the three dose groups [8 U (0.1 mL), 16 U (0.2 mL), or 32 U (0.4 mL)]."
190184|NCT01601236|P6|Participant Flow|Group 6: Placebo (0.4 mL) Daily|Placebo: contains the same inactive ingredients as H.P. Acthar Gel without the API administered via daily SC injection for 36 weeks
190185|NCT01601236|P5|Participant Flow|Group 5: Acthar 32 U (0.4 mL) Daily|H.P. Acthar Gel (repository corticotropin injection) administered via daily SC injection for 36 weeks
190186|NCT01601236|P4|Participant Flow|Group 4: Placebo (0.2 mL) Daily|Placebo: contains the same inactive ingredients as H.P. Acthar Gel without the API administered via daily SC injection for 36 weeks
190187|NCT01601236|P3|Participant Flow|Group 3: Acthar 16 U (0.2 mL) Daily|H.P. Acthar Gel (repository corticotropin injection) administered via daily SC injection for 36 weeks
190188|NCT01601236|P2|Participant Flow|Group 2: Placebo (0.1 mL) Daily|Placebo: contains the same inactive ingredients as H.P. Acthar Gel without the active pharmaceutical ingredient (API)administered via daily SC injection for 36 weeks
190189|NCT01601236|P1|Participant Flow|Group 1: Acthar 8 U (0.1 mL) Daily|H.P. Acthar Gel (repository corticotropin injection) administered via daily subcutaneous (SC) injection for 36 weeks
190190|NCT01601236|O3|Outcome|Acthar 16 Units|Groups 3, 5
190191|NCT01601236|O2|Outcome|Acthar 8 Units|Group 1
190192|NCT01601236|O1|Outcome|Placebo|Groups 2, 4, 6
190193|NCT01601236|O3|Outcome|Acthar 16 Units|Groups 3, 5
190194|NCT01601236|O2|Outcome|Acthar 8 Units|Group 1
190195|NCT01601236|O1|Outcome|Placebo|Groups 2, 4, 6
190196|NCT01601236|O3|Outcome|Acthar 16 Units|Groups 3, 5
190197|NCT01601236|O2|Outcome|Acthar 8 Units|Group 1
190198|NCT01601236|O1|Outcome|Placebo|Groups 2, 4, 6
190199|NCT01601236|O3|Outcome|Acthar 16 Units|Groups 3, 5
190200|NCT01601236|O2|Outcome|Acthar 8 Units|Group 1
190201|NCT01601236|O1|Outcome|Placebo|Groups 2, 4, 6
190202|NCT01601236|O3|Outcome|Acthar 16 Units|Groups 3, 5
190203|NCT01601236|O2|Outcome|Acthar 8 Units|Group 1
190204|NCT01601236|O1|Outcome|Placebo|Groups 2, 4, 6
190205|NCT01601236|O3|Outcome|Acthar 16 Units|Groups 3, 5
190206|NCT01601236|O2|Outcome|Acthar 8 Units|Group 1
190207|NCT01601236|O1|Outcome|Placebo|Groups 2, 4, 6
190208|NCT01601236|O3|Outcome|Acthar 16 Units|Groups 3, 5
190209|NCT01601236|O2|Outcome|Acthar 8 Units|Group 1
190210|NCT01601236|O1|Outcome|Placebo|Groups 2, 4, 6
190211|NCT01601236|O3|Outcome|Acthar 16 Units|Groups 3, 5
190212|NCT01601236|O2|Outcome|Acthar 8 Units|Group 1
190213|NCT01601236|O1|Outcome|Placebo|Groups 2, 4, 6
190214|NCT01601236|O3|Outcome|Acthar 16 Units|Groups 3, 5
190215|NCT01601236|O2|Outcome|Acthar 8 Units|Group 1
190216|NCT01601236|O1|Outcome|Placebo|Groups 2, 4, 6
190217|NCT01601236|O3|Outcome|Acthar 16 Units|Groups 3, 5
190218|NCT01601236|O2|Outcome|Acthar 8 Units|Group 1
190219|NCT01601236|O1|Outcome|Placebo|Groups 2, 4, 6
190220|NCT01601236|E4|Reported Event|Overall|Groups 1, 2, 3, 4, 5, 6
190221|NCT01601236|E3|Reported Event|Acthar 16 Units|Groups 3, 5; This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3). Thus, Adverse Events were not collected separately for these Arms.
190222|NCT01601236|E2|Reported Event|Acthar 8 Units|Group 1
190223|NCT01601236|E1|Reported Event|Placebo|Groups 2, 4, 6
190224|NCT01601132|B1|Baseline|Theophylline + Colchicine|Theophylline 300 mg, solution, orally, on Day 1, then colchicine 0.6 mg tablets, orally, twice daily on Days 5–18, then theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
190225|NCT01601132|P1|Participant Flow|Theophylline + Colchicine|Theophylline 300 mg, solution, orally, on Day 1, then colchicine 0.6 mg tablets, orally, twice daily on Days 5–18, then theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
190226|NCT01601132|O2|Outcome|Theophylline + Colchicine|Theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
190227|NCT01601132|O1|Outcome|Theophylline|Theophylline 300 mg, solution, orally, on Day 1.
190228|NCT01601132|O2|Outcome|Theophylline + Colchicine|Theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
190234|NCT01601132|O2|Outcome|Theophylline + Colchicine|Theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
190235|NCT01601132|O1|Outcome|Theophylline|Theophylline 300 mg, solution, orally, on Day 1.
190236|NCT01601132|O2|Outcome|Theophylline + Colchicine|Theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
190237|NCT01601132|O1|Outcome|Theophylline|Theophylline 300 mg, solution, orally, on Day 1.
190238|NCT01601132|E3|Reported Event|Colchicine + Theophylline|Theophylline 300 mg, solution, orally, single dose and colchicine 0.6 mg, tablets, orally, twice daily, on Day 19.
190239|NCT01601132|E2|Reported Event|Colchicine|Colchicine, 0.6 mg tablet, orally, twice daily, from Days 5-18.
190240|NCT01601132|E1|Reported Event|Theophylline|Theophylline 300 mg, solution, orally, on Day 1, followed by a 4-day washout period.
190241|NCT01600950|B1|Baseline|All Participants|A single 0.3 units/kilogram (U/kg) dose of either LY2963016 or LANTUS was administered subcutaneously on Day 1 of Periods 1 or 2.
190242|NCT01600950|P2|Participant Flow|Lantus/LY2963016|"A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 during Period 1 followed by a minimum washout period of 7 days.~A single 0.3 U/kg dose of LY2963016 was administered subcutaneously on Day 1 during Period 2."
190243|NCT01600950|P1|Participant Flow|LY2963016/Lantus|"A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 during Period 1 followed by a minimum washout period of 7 days.~A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 during Period 2."
190244|NCT01600950|O2|Outcome|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
190245|NCT01600950|O1|Outcome|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
190246|NCT01600950|O2|Outcome|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
190247|NCT01600950|O1|Outcome|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
190248|NCT01600950|O2|Outcome|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
190249|NCT01600950|O1|Outcome|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
190250|NCT01600950|O2|Outcome|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
190251|NCT01600950|O1|Outcome|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
190252|NCT01600950|O2|Outcome|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
190253|NCT01600950|O1|Outcome|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
190254|NCT01600950|O2|Outcome|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
190255|NCT01600950|O1|Outcome|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
190256|NCT01600950|E2|Reported Event|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
190257|NCT01600950|E1|Reported Event|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
190258|NCT01600885|B1|Baseline|Overall Study|This 'arm' consists of all study participants who started the first Study Period. This Study Period consisted of an initial screening visit in which it was determined whether participants met the inclusion/exclusion criteria for further participation in this study.
190259|NCT01600885|P2|Participant Flow|Placebo Then Guanfacine|"During the first study session, the participant will receive a placebo before undergoing a ketamine-infusion fMRI. During the second study session, at least two weeks later, the participant will receive guanfacine before undergoing a ketamine-infusion fMRI.~Placebo then Guanfacine: During the first study session, the patient will be given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) will be given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant will receive a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation will be measured during a spatial working memory task. The entire scan will last approximately two and a half hours and the ketamine infusion will be up to one hour and 15 minutes.~The second study session will be identical except that the patient will be given 3mg of guanfacine instead of the placebo."
190260|NCT01600885|P1|Participant Flow|Guanfacine Then Placebo|"During the first study session, the participant will receive guanfacine before undergoing a ketamine-infusion fMRI. During the second study session, at least two weeks later, the participant will receive a placebo before undergoing a ketamine-infusion fMRI.~Guanfacine then Placebo: During the first study session, the patient will be given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) will be given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant will receive a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation will be measured during a spatial working memory task. The entire scan will last approximately two and a half hours and the ketamine infusion will be up to one hour and 15 minutes.~The second study session will be identical except that the patient will be given a placebo instead of the guanfacine."
190261|NCT01600885|O2|Outcome|Placebo|Subjects were given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
190262|NCT01600885|O1|Outcome|Guanfacine|Subjects were given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the subjects received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
190263|NCT01600885|O2|Outcome|Placebo|Subjects were given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
190264|NCT01600885|O1|Outcome|Guanfacine|Subjects were given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the subjects received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
190265|NCT01600885|O2|Outcome|Placebo|Subjects were given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
190266|NCT01600885|O1|Outcome|Guanfacine|Subjects were given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the subjects received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
190267|NCT01600885|E2|Reported Event|Placebo|Subjects were given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the subjects received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
190268|NCT01600885|E1|Reported Event|Guanfacine|Subjects were given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the subjects received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
190269|NCT01600729|B1|Baseline|All Participants|Participants with facial lines. There was no intervention in this study.
190270|NCT01600729|P1|Participant Flow|All Participants|Participants with facial lines. There was no intervention in this study.
190271|NCT01600729|O1|Outcome|All Participants|Participants with facial lines. There was no intervention in this study.
190272|NCT01600729|O1|Outcome|All Participants|Participants with facial lines. There was no intervention in this study.
190273|NCT01600729|E1|Reported Event|All Participants|Participants with facial lines. There was no intervention in this study.
190274|NCT01600716|B3|Baseline|Total|Total of all reporting groups
190275|NCT01600716|B2|Baseline|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
190276|NCT01600716|B1|Baseline|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
190277|NCT01600716|P2|Participant Flow|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
190278|NCT01600716|P1|Participant Flow|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
190279|NCT01600716|O2|Outcome|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
190280|NCT01600716|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
190281|NCT01600716|O2|Outcome|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
190282|NCT01600716|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
190283|NCT01600716|O2|Outcome|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
190284|NCT01600716|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
190285|NCT01600716|O2|Outcome|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
190286|NCT01600716|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
190287|NCT01600716|O2|Outcome|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
190288|NCT01600716|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
190289|NCT01600716|E4|Reported Event|Placebo (Normal Saline)/OnabotulinumtoxinA|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, an onabotulinumtoxinA injection is given. Median duration of exposure is 12.2 weeks.
194330|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
190290|NCT01600716|E3|Reported Event|OnabotulinumtoxinA/OnabotulinumtoxinA Treatment Cycle 2|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, a second onabotulinumtoxinA injection is given. Median duration of exposure is 12.5 weeks.
190291|NCT01600716|E2|Reported Event|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. Median duration of exposure is 15.2 weeks.
190292|NCT01600716|E1|Reported Event|OnabotulinumtoxinA Treatment Cycle 1|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. Median duration of exposure is 50.7 weeks.
190293|NCT01600703|B1|Baseline|All Study Participants|placebo, oral, single dose sitagliptin, 100 mg, oral, single dose
190294|NCT01600703|P2|Participant Flow|Sitagliptin First, Then Placebo|placebo, oral, single dose sitagliptin, 100 mg, oral, single dose
190295|NCT01600703|P1|Participant Flow|Placebo First, Then Sitagliptin|placebo, oral, single dose sitagliptin, 100 mg, oral, single dose
190296|NCT01600703|O2|Outcome|Sitagliptin|sitagliptin, 100 mg, oral, single dose
190297|NCT01600703|O1|Outcome|Placebo|placebo, oral, single dose
190298|NCT01600703|O2|Outcome|Sitagliptin|sitagliptin, 100 mg, oral, single dose
190299|NCT01600703|O1|Outcome|Placebo|placebo, oral, single dose
190300|NCT01600703|E2|Reported Event|Sitagliptin|sitagliptin, 100mg, oral, single dose
190301|NCT01600703|E1|Reported Event|Placebo|placebo, oral, single dose
190302|NCT01600677|B3|Baseline|Total|Total of all reporting groups
190303|NCT01600677|B2|Baseline|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.~Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
190304|NCT01600677|B1|Baseline|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.~Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
190305|NCT01600677|P2|Participant Flow|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.~Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
190306|NCT01600677|P1|Participant Flow|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.~Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
190307|NCT01600677|O2|Outcome|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.~Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
190308|NCT01600677|O1|Outcome|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.~Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
190309|NCT01600677|O2|Outcome|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.~Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
190310|NCT01600677|O1|Outcome|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.~Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
190311|NCT01600677|O2|Outcome|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.~Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
190312|NCT01600677|O1|Outcome|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.~Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
190313|NCT01600677|E2|Reported Event|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.~Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
190314|NCT01600677|E1|Reported Event|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.~Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
190315|NCT01600586|B3|Baseline|Total|Total of all reporting groups
190316|NCT01600586|B2|Baseline|Books, No PAL Group|No PAL
190317|NCT01600586|B1|Baseline|Books, PAL Group|"PAL group~Pacifier-Activated-Lullaby system (PAL).: Pacifier-Activated-Lullaby system (PAL).~Infants were randomly assigned by using a block system to control or intervention groups. Eligible siblings were enrolled into the same group because they shared the same room in the NICU. If 1 child received the PAM intervention while the other engaged in NNS, diffusion of treatment might occur; removal of the siblings’ pacifier during the pacifier-activated lullaby (PAL) was not an alternative acceptable to nursing staff."
190318|NCT01600586|P2|Participant Flow|Books, No PAL Group|"No PAL~At enrollment, all mother-infant dyads received a set of 4 well-known children’s books, 2 of which were single-story songbooks. Mothers in both groups were encouraged to read and sing to their infants whenever they were present; no time quota, schedule, or log was provided. Mothers were informed that the study’s objective was to evaluate the influence of their voice on their infant’s feeding ability."
190319|NCT01600586|P1|Participant Flow|Books, PAL Group|"PAL group~Pacifier-Activated-Lullaby system (PAL).: Pacifier-Activated-Lullaby system (PAL)."
190320|NCT01600586|O2|Outcome|Books, No PAL Group|"No PAL~At enrollment, all mother-infant dyads received a set of 4 well-known children’s books, 2 of which were single-story songbooks. Mothers in both groups were encouraged to read and sing to their infants whenever they were present; no time quota, schedule, or log was provided. Mothers were informed that the study’s objective was to evaluate the influence of their voice on their infant’s feeding ability."
190321|NCT01600586|O1|Outcome|Books, PAL Group|"PAL group~Pacifier-Activated-Lullaby system (PAL).: Pacifier-Activated-Lullaby system (PAL)."
190322|NCT01600586|O2|Outcome|Books, No PAL Group|No PAL
190323|NCT01600586|O1|Outcome|Books, PAL Group|"PAL group~Pacifier-Activated-Lullaby system (PAL).: Pacifier-Activated-Lullaby system (PAL)."
190324|NCT01600586|O2|Outcome|This is the NO PAL Group|This is the NO PAL group
190325|NCT01600586|O1|Outcome|This is the PAL Intervention Group|This is the PAL intervention group
190326|NCT01600586|O2|Outcome|No PAL|This group received no PAL intervention
190327|NCT01600586|O1|Outcome|This is the PAL Intervention|This group received intervention
190328|NCT01600586|O2|Outcome|No PAL Intervention|This group of participants did not receive PAL intervention
190329|NCT01600586|O1|Outcome|PAL Intervention|This group of participants received PAL intervention
190330|NCT01600586|E2|Reported Event|Books, No PAL Group|No PAL
190331|NCT01600586|E1|Reported Event|PAL Group|"PAL group~Pacifier-Activated-Lullaby system (PAL).: Pacifier-Activated-Lullaby system (PAL)."
190332|NCT01600495|B3|Baseline|Total|Total of all reporting groups
190333|NCT01600495|B2|Baseline|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
190334|NCT01600495|B1|Baseline|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
190335|NCT01600495|P2|Participant Flow|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
190336|NCT01600495|P1|Participant Flow|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
190337|NCT01600495|O2|Outcome|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
190338|NCT01600495|O1|Outcome|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm.
190339|NCT01600495|O2|Outcome|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
190341|NCT01600495|O2|Outcome|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
190342|NCT01600495|O1|Outcome|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm.
190343|NCT01600495|O2|Outcome|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
190344|NCT01600495|O1|Outcome|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
190345|NCT01600495|E2|Reported Event|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
190346|NCT01600495|E1|Reported Event|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
190347|NCT01600482|B3|Baseline|Total|Total of all reporting groups
190348|NCT01600482|B2|Baseline|Manual Compression|Manual Compression
190349|NCT01600482|B1|Baseline|CELT ACD Device|"The CELT ACD device is a vascular closure device.~CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath."
190350|NCT01600482|P2|Participant Flow|Manual Compression|Manual Compression
190351|NCT01600482|P1|Participant Flow|CELT ACD Device|"The CELT ACD device is a vascular closure device.~CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath."
190352|NCT01600482|O2|Outcome|Manual Compression|Manual Compression
190353|NCT01600482|O1|Outcome|CELT ACD Device|"The CELT ACD device is a vascular closure device.~CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath."
190354|NCT01600482|O2|Outcome|Manual Compression|Manual Compression
190355|NCT01600482|O1|Outcome|CELT ACD Device|"The CELT ACD device is a vascular closure device.~CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath."
190356|NCT01600482|O2|Outcome|Manual Compression|Manual Compression
190357|NCT01600482|O1|Outcome|CELT ACD Device|"The CELT ACD device is a vascular closure device.~CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath."
190358|NCT01600482|O2|Outcome|Manual Compression|Manual Compression
190359|NCT01600482|O1|Outcome|CELT ACD Device|"The CELT ACD device is a vascular closure device.~CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath."
190360|NCT01600482|O2|Outcome|Manual Compression|Manual Compression
190361|NCT01600482|O1|Outcome|CELT ACD Device|"The CELT ACD device is a vascular closure device.~CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath."
190362|NCT01600482|O2|Outcome|Manual Compression|Manual Compression
190363|NCT01600482|O1|Outcome|CELT ACD Device|"The CELT ACD device is a vascular closure device.~CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath."
190364|NCT01600482|O2|Outcome|Manual Compression|Manual Compression
190365|NCT01600482|O1|Outcome|CELT ACD Device|"The CELT ACD device is a vascular closure device.~CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath."
190366|NCT01600482|E2|Reported Event|Manual Compression|Manual Compression
190367|NCT01600482|E1|Reported Event|CELT ACD Device|"The CELT ACD device is a vascular closure device.~CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath."
190368|NCT01600326|B3|Baseline|Total|Total of all reporting groups
190369|NCT01600326|B2|Baseline|Plasma Injection Group|"Treatment is Ultrasound guided platelet rich plasma injection.~Ultrasound guided platelet rich plasma injection: Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm.~The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called Ultrasound guided platelet rich plasma injection.~Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study.~Subjects will see their referring physician two weeks after treatment to begin physical therapy."
190370|NCT01600326|B1|Baseline|Tenotomy Group|"Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.~Tenotomy (no injection): Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy."
190386|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
190387|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
190371|NCT01600326|P2|Participant Flow|Plasma Injection Group|"Treatment is Ultrasound guided platelet rich plasma injection.~Ultrasound guided platelet rich plasma injection: Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm.~The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called Ultrasound guided platelet rich plasma injection.~Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study.~Subjects will see their referring physician two weeks after treatment to begin physical therapy."
190372|NCT01600326|P1|Participant Flow|Tenotomy Group|"Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.~Tenotomy (no injection): Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy."
190373|NCT01600326|O2|Outcome|Plasma Injection Group|"Treatment is Ultrasound guided platelet rich plasma injection.~Ultrasound guided platelet rich plasma injection: Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm.~The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called Ultrasound guided platelet rich plasma injection.~Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study.~Subjects will see their referring physician two weeks after treatment to begin physical therapy."
190374|NCT01600326|O1|Outcome|Tenotomy Group|"Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.~Tenotomy (no injection): Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy."
190375|NCT01600326|O2|Outcome|Plasma Injection Group|"Treatment is Ultrasound guided platelet rich plasma injection.~Ultrasound guided platelet rich plasma injection: Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm.~The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called Ultrasound guided platelet rich plasma injection.~Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study.~Subjects will see their referring physician two weeks after treatment to begin physical therapy."
190376|NCT01600326|O1|Outcome|Tenotomy Group|"Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.~Tenotomy (no injection): Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy."
190377|NCT01600326|E2|Reported Event|Plasma Injection Group|"Treatment is Ultrasound guided platelet rich plasma injection.~Ultrasound guided platelet rich plasma injection: Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm.~The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called Ultrasound guided platelet rich plasma injection.~Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study.~Subjects will see their referring physician two weeks after treatment to begin physical therapy."
190378|NCT01600326|E1|Reported Event|Tenotomy Group|"Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.~Tenotomy (no injection): Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy."
190379|NCT01600287|B3|Baseline|Total|Total of all reporting groups
190380|NCT01600287|B2|Baseline|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
190381|NCT01600287|B1|Baseline|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
190382|NCT01600287|P2|Participant Flow|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
190383|NCT01600287|P1|Participant Flow|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
190384|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
190385|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
190510|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190388|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
190389|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
190390|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
190391|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
190392|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
190393|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
190394|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
190395|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
190396|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
190397|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
190398|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
190399|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
190400|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
190401|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
190402|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
190403|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
190404|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
190405|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
190406|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
190407|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
190408|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
190409|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
190410|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
190411|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
190412|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
190413|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
190414|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
190415|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
190416|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
190417|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
190418|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
190478|NCT01600014|O1|Outcome|Open Label Only (1st Cycle)|Subjects only treated during 1st cycle (450 participants excluding 203 participants also included in the 2nd cycle)
190419|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
190420|NCT01600287|E2|Reported Event|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
190421|NCT01600287|E1|Reported Event|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
190422|NCT01600222|B1|Baseline|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
190423|NCT01600222|P1|Participant Flow|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Once daily for up to 4 weeks
190424|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Once daily for up to 4 weeks
190425|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
190426|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
190427|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
190428|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
190429|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
190430|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
190431|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
190432|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
190433|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
190434|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
190435|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
190436|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
190437|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
190438|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
190439|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
190440|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
190441|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
190442|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
190443|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
190444|NCT01600222|E1|Reported Event|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
190445|NCT01600092|B3|Baseline|Total|Total of all reporting groups
190446|NCT01600092|B2|Baseline|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
190447|NCT01600092|B1|Baseline|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
190448|NCT01600092|P2|Participant Flow|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
190449|NCT01600092|P1|Participant Flow|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
190450|NCT01600092|O2|Outcome|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
190451|NCT01600092|O1|Outcome|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
190452|NCT01600092|O2|Outcome|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
190453|NCT01600092|O1|Outcome|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
190454|NCT01600092|O2|Outcome|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
190500|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190501|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190455|NCT01600092|O1|Outcome|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
190456|NCT01600092|O2|Outcome|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
190457|NCT01600092|O1|Outcome|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
190458|NCT01600092|O2|Outcome|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
190459|NCT01600092|O1|Outcome|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
190460|NCT01600092|E2|Reported Event|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
190461|NCT01600092|E1|Reported Event|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
190462|NCT01600053|B1|Baseline|Lenalidomide|"Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles~Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each."
190463|NCT01600053|P1|Participant Flow|Lenalidomide|"Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles~Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each."
190464|NCT01600053|O1|Outcome|Lenalidomide|"Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles~Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each."
190465|NCT01600053|O1|Outcome|Lenalidomide|"Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles~Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each."
190466|NCT01600053|E1|Reported Event|Lenalidomide|"Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles~Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each."
190467|NCT01600014|B1|Baseline|Ingenol Mebutate 0.015% Gel (1.& 2. Cycle)|Open label topical field treatment once daily for 3 consecutive days with ingenol mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by observation and/or controlled repeat use (2nd cycle) treatment of recalcitrant or recurrent AK lesions
190468|NCT01600014|P2|Participant Flow|Vehicle Gel (2nd Cycle)|Open label topical field treatment once daily for 3 consecutive days with mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by observation and/or repeat use (2nd cycle) once daily for 3 consecutive days with vehicle gel of the same treatment area, in a randomised, controlled, double-blind setting, at Week 8 (field recalcitrant subgroup) or Week 26 or Week 44 (field recurrent subgroup) with follow-up until Week 52
190469|NCT01600014|P1|Participant Flow|Ingenol Mebutate Gel, 0.015% (1st & 2nd Cycle)|Open label topical field treatment once daily for 3 consecutive days with ingenol mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by observation and/or repeat use (2nd cycle) once daily for 3 consecutive days with ingenol mebutate 0.015% gel of the same treatment area, in a randomised, controlled, double-blind setting, at Week 8 (field recalcitrant subgroup) or Week 26 or Week 44 (field recurrent subgroup) with follow-up until Week 52
190470|NCT01600014|O4|Outcome|Vehicle Gel Field Recurrent Subgroup|See primary endpoint for previously defined description
190471|NCT01600014|O3|Outcome|Ingenol Mebutate Gel 0.015% Field Recurrent Subgroup|See primary endpoint for previously defined description
190472|NCT01600014|O2|Outcome|Vehicle Gel Field Recalcitrant Subgroup|See primary endpoint for previously defined description
190473|NCT01600014|O1|Outcome|Ingenol Mebutate Gel, 0.015% Field Recalcitrant Subgroup|See primary endpoint for previously defined description
190474|NCT01600014|O5|Outcome|Vehicle Gel Field Recurrent Subgroup|See primary endpoint for previously defined description
190475|NCT01600014|O4|Outcome|Ingenol Mebutate Gel 0.015% Field Recurrent Subgroup|See primary endpoint for previously defined description
190476|NCT01600014|O3|Outcome|Vehicle Gel Field Recalcitrant Subgroup|See primary endpoint for previously defined description
190477|NCT01600014|O2|Outcome|Ingenol Mebutate Gel, 0.015% Field Recalcitrant Subgroup|See primary endpoint for previously defined description
190479|NCT01600014|O4|Outcome|Vehicle Gel Field Recurrent Subgroup|Open label topical field treatment once daily for 3 consecutive days with mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by once daily for 3 consecutive days with vehicle gel of the same treatment area (2nd cycle), in a randomised, controlled, double-blind setting, at Week 26 or Week 44 with follow-up until Week 52
190480|NCT01600014|O3|Outcome|Ingenol Mebutate Gel 0.015% Field Recurrent Subgroup|Open label topical field treatment once daily for 3 consecutive days with ingenol mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by once daily for 3 consecutive days with ingenol mebutate 0.015% gel of the same treatment area (2nd cycle), in a randomised, controlled, double-blind setting, at Week 26 or Week 44 with follow-up until Week 52
190481|NCT01600014|O2|Outcome|Vehicle Gel Field Recalcitrant Subgroup|Open label topical field treatment once daily for 3 consecutive days with mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by once daily for 3 consecutive days with vehicle gel of the same treatment area (2nd cycle), in a randomised, controlled, double-blind setting, at Week 8 with follow-up until Week 52
190482|NCT01600014|O1|Outcome|Ingenol Mebutate Gel, 0.015% Field Recalcitrant Subgroup|Open label topical field treatment once daily for 3 consecutive days with ingenol mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by once daily for 3 consecutive days with ingenol mebutate 0.015% gel of the same treatment area (2nd cycle), in a randomised, controlled, double-blind setting, at Week 8 with follow-up until Week 52
190483|NCT01600014|E3|Reported Event|Vehicle Gel (2. Cycle)|Repeat use once daily for 3 consecutive days with vehicle gel of the same treatment area (25 cm2 treatment area on the face or scalp) in a randomised, controlled, double-blind setting, at Week 8 (field recalcitrant subgroup) or Week 26 or Week 44 (field recurrent subgroup)
190484|NCT01600014|E2|Reported Event|Ingenol Mebutate 0.015% Gel (2. Cycle)|Repeat use once daily for 3 consecutive days with ingenol mebutate 0.015% gel of the same treatment area (25 cm2 treatment area on the face or scalp) in a randomised, controlled, double-blind setting, at Week 8 (field recalcitrant subgroup) or Week 26 or Week 44 (field recurrent subgroup)
190485|NCT01600014|E1|Reported Event|Ingenol Mebutate 0.015% Gel (1. Cycle)|Open label topical field treatment once daily for 3 consecutive days with ingenol mebutate 0.015% gel within a 25 cm2 treatment area on the face or scalp
190486|NCT01599832|B1|Baseline|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.~pazopanib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging~pharmacogenomic studies: Correlative studies"
190487|NCT01599832|P1|Participant Flow|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.~pazopanib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging~pharmacogenomic studies: Correlative studies"
190488|NCT01599832|O1|Outcome|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.~pazopanib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging~pharmacogenomic studies: Correlative studies"
190489|NCT01599832|O1|Outcome|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.~pazopanib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging~pharmacogenomic studies: Correlative studies"
190490|NCT01599832|O1|Outcome|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.~pazopanib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging~pharmacogenomic studies: Correlative studies"
190491|NCT01599832|O1|Outcome|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.~pazopanib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging~pharmacogenomic studies: Correlative studies"
190492|NCT01599832|O1|Outcome|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.~pazopanib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging~pharmacogenomic studies: Correlative studies"
190493|NCT01599832|E1|Reported Event|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.~pazopanib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging~pharmacogenomic studies: Correlative studies"
190494|NCT01599806|B3|Baseline|Total|Total of all reporting groups
190495|NCT01599806|B2|Baseline|Doripenem|Doripenem treatment group
190496|NCT01599806|B1|Baseline|CAZ-AVI|Ceftazidime-avibactam treatment group
190497|NCT01599806|P2|Participant Flow|Doripenem|Doripenem treatment group
190498|NCT01599806|P1|Participant Flow|CAZ-AVI|Ceftazidime-avibactam treatment group
190499|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190512|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190513|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190514|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190515|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190516|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190517|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190518|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190519|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190520|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190521|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190522|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190523|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190524|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190525|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190526|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190527|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190528|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190529|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190530|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190531|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190532|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190533|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190534|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190535|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190536|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190537|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190538|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190539|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190540|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190541|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190542|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190543|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190544|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190545|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190546|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190547|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190548|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190549|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190550|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190551|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190552|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190553|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190554|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190555|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190556|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190557|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190558|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190559|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190560|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190561|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190562|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190563|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190564|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190565|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190566|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190567|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190568|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190569|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190570|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190571|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190572|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190573|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190574|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190575|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190576|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190577|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190578|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190579|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190580|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190581|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190582|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190583|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190584|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190585|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190586|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190587|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190588|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190589|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190590|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190591|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190592|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190594|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190595|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190596|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190597|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190598|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190599|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190600|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190601|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190602|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190603|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190604|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190605|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190606|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190607|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190608|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190609|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190610|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190611|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190612|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190613|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190614|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190615|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190616|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190617|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
190618|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
190619|NCT01599806|E2|Reported Event|Doripenem|Doripenem treatment group
190620|NCT01599806|E1|Reported Event|CAZ-AVI|Ceftazidime-avibactam treatment group
190621|NCT01599741|B1|Baseline|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ
190622|NCT01599741|P1|Participant Flow|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper directly followed by DSA with ClarityIQ
190623|NCT01599741|O1|Outcome|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ or visa versa.
190624|NCT01599741|O1|Outcome|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ or visa versa.
190625|NCT01599741|O1|Outcome|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ or visa versa.
190626|NCT01599741|E1|Reported Event|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ
190627|NCT01599650|B4|Baseline|Total|Total of all reporting groups
190628|NCT01599650|B3|Baseline|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
190629|NCT01599650|B2|Baseline|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
190630|NCT01599650|B1|Baseline|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
190631|NCT01599650|P3|Participant Flow|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
190632|NCT01599650|P2|Participant Flow|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
190633|NCT01599650|P1|Participant Flow|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
190634|NCT01599650|O1|Outcome|3- Laser Monotherapy|laser therapy + Ranibizumab 0.5 mg after Month 6
190635|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
190636|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
190637|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
190638|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
190639|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
190640|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
190641|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
190642|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
190643|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
190644|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
190645|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
190646|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
190647|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
190648|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
190649|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
190650|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
190651|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
190652|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
190653|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
190654|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
190655|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
190656|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
190657|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
190658|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
190659|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
190660|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
190661|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
190662|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
190663|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
190664|NCT01599650|E4|Reported Event|Laser Monotherapy Without Ranibizumab 0.5 mg From Month 6|Laser monotherapy without Ranibizumab 0.5 mg from Month 6
190665|NCT01599650|E3|Reported Event|Laser Monotherapy With Ranibizumab 0.5 mg From Month 6|Laser monotherapy with Ranibizumab 0.5 mg from Month 6
190666|NCT01599650|E2|Reported Event|Ranibizumab 0.5mg + Laser|"Ranibizumab 0.5mg + Laser~[1] Safety set was summarized based on actual treatment received. There were 3 laser monotherapy patients who received ranibizumab and 1 ranibizumab patient who received laser treatment which resulted in percentages > 100% for the ranibizumab + laser arm."
190667|NCT01599650|E1|Reported Event|Ranibizumab 0.5mg|Ranibizumab 0.5mg
190668|NCT01599637|B4|Baseline|Total|Total of all reporting groups
190669|NCT01599637|B3|Baseline|Healthy Volunteers|Healthy volunteer data was collected at baseline only. These healthy volunteers did not receive any test treatment. The data collected from these individuals was used to provide a reference to help characterize the levels of skin biopsy markers and were used in the descriptive analyses but not formally compared with the corresponding levels in the treated subjects
190670|NCT01599637|B2|Baseline|Placebo to IGE025|Placebo administered subcutaneously every 4 weeks at the study center.
190671|NCT01599637|B1|Baseline|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
190672|NCT01599637|P3|Participant Flow|Healthy Volunteers|Healthy volunteer data was collected at baseline only. These healthy volunteers did not receive any test treatment. The data collected from these individuals was used to provide a reference to help characterize the levels of skin biopsy markers and were used in the descriptive analyses but not formally compared with the corresponding levels in the treated subjects
190673|NCT01599637|P2|Participant Flow|Placebo to IGE025|Placebo administered subcutaneously every 4 weeks at the study center.
190674|NCT01599637|P1|Participant Flow|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
190675|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
190676|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
190677|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
190678|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
190679|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
190680|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
190681|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
190682|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
190683|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
190684|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
190685|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
190686|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
190687|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
190688|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
190689|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
190690|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
190691|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
190692|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
190693|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
190694|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
190695|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
190696|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
190697|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
190698|NCT01599637|O2|Outcome|Urticaria Patients|All patients for study at baseline
190699|NCT01599637|O1|Outcome|Healthy Subjects|Baseline Value, healthy volunteers, no treatment applied
190700|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
190701|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
190702|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
190703|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
190704|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
190705|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
190706|NCT01599637|O2|Outcome|Placebo IGE025|Dosed every 4 weeks up to 12 weeks
190707|NCT01599637|O1|Outcome|IGE025|Dosed every 4 weeks up to 12 weeks
190708|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
190709|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
190710|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
190711|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
190712|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
190713|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
190714|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
190715|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
190716|NCT01599637|E2|Reported Event|Placebo|Placebo administered subcutaneously every 4 weeks at the study center.
190717|NCT01599637|E1|Reported Event|IGE025 300mg|IGE025 administered subcutaneously every 4 weeks at the study center
190718|NCT01599585|B3|Baseline|Total|Total of all reporting groups
190719|NCT01599585|B2|Baseline|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190720|NCT01599585|B1|Baseline|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190721|NCT01599585|P2|Participant Flow|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190722|NCT01599585|P1|Participant Flow|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190723|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190724|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190725|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190726|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190727|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190728|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190729|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190773|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
190730|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190731|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190732|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190733|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190734|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190735|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190736|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190737|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190738|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190739|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190740|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190741|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190742|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190743|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190744|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190745|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190746|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190747|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190748|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190749|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190750|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190751|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190752|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190753|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190754|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190755|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190756|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190757|NCT01599585|E2|Reported Event|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190758|NCT01599585|E1|Reported Event|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
190759|NCT01599325|B1|Baseline|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
190760|NCT01599325|P1|Participant Flow|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
190761|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
190762|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
190763|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
190764|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
190765|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
190766|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
190767|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
190768|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
190769|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
190770|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
190771|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
190772|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
190809|NCT01599104|P2|Participant Flow|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
190774|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
190775|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
190776|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
190777|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
190778|NCT01599325|E1|Reported Event|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
190779|NCT01599234|B3|Baseline|Total|Total of all reporting groups
190780|NCT01599234|B2|Baseline|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
190781|NCT01599234|B1|Baseline|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
190782|NCT01599234|P2|Participant Flow|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
190783|NCT01599234|P1|Participant Flow|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
190784|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
190785|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
190786|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
190787|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
190788|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
190789|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
190790|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
190791|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
190792|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
190793|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
190794|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
190795|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
190796|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
190797|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
190798|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
190799|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
190800|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
190801|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
190802|NCT01599234|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
190803|NCT01599234|E1|Reported Event|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
190804|NCT01599104|B4|Baseline|Total|Total of all reporting groups
190805|NCT01599104|B3|Baseline|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
190806|NCT01599104|B2|Baseline|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
190807|NCT01599104|B1|Baseline|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
190808|NCT01599104|P3|Participant Flow|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
190810|NCT01599104|P1|Participant Flow|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
190811|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
190812|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
190813|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
190814|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
190815|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
190816|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
190817|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
190818|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
190819|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
190820|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
190821|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
190822|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
190823|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
190824|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
190825|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
190826|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
190827|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
190828|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
190829|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
190830|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
190831|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
190832|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
190833|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
190834|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
190835|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
190836|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
190837|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
190838|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
190839|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
190840|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
190841|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
190842|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
190843|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
190844|NCT01599104|E3|Reported Event|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
190845|NCT01599104|E2|Reported Event|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
190846|NCT01599104|E1|Reported Event|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
190847|NCT01598987|B1|Baseline|Everolimus Based Regimen|"Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).~The dosing schedule was twice daily, 12 hours apart."
190848|NCT01598987|P1|Participant Flow|Everolimus Based Regimen|"Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).~The dosing schedule was twice daily, 12 hours apart."
190849|NCT01598987|O7|Outcome|Total|The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
190850|NCT01598987|O6|Outcome|>95% Percentile|Growth percentile category
190851|NCT01598987|O5|Outcome|>75% - 95% Percentile|Growth percentile category
190852|NCT01598987|O4|Outcome|>50% - 75% Percentile|Growth percentile categpru
190853|NCT01598987|O3|Outcome|>25% - 50% Percentile|Growth percentile category
190854|NCT01598987|O2|Outcome|>5% - 25% Percentile|Growth percentile category
190855|NCT01598987|O1|Outcome|<=5% Percentile|Growth percentile category
190856|NCT01598987|O7|Outcome|Total|The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
190857|NCT01598987|O6|Outcome|>95% Percentile|Growth percentile category
190858|NCT01598987|O5|Outcome|>75% - 95% Percentile|Growth percentile category
190859|NCT01598987|O4|Outcome|>50% - 75% Percentile|Growth percentile categpru
190860|NCT01598987|O3|Outcome|>25% - 50% Percentile|Growth percentile category
190861|NCT01598987|O2|Outcome|>5% - 25% Percentile|Growth percentile category
190862|NCT01598987|O1|Outcome|<=5% Percentile|Growth percentile category
190863|NCT01598987|O7|Outcome|Total|The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
190864|NCT01598987|O6|Outcome|>95% Percentile|Growth percentile category
190865|NCT01598987|O5|Outcome|>75% - 95% Percentile|Growth percentile category
190866|NCT01598987|O4|Outcome|>50% - 75% Percentile|Growth percentile categpru
190867|NCT01598987|O3|Outcome|>25% - 50% Percentile|Growth percentile category
190868|NCT01598987|O2|Outcome|>5% - 25% Percentile|Growth percentile category
190869|NCT01598987|O1|Outcome|<=5% Percentile|Growth percentile category
190870|NCT01598987|O7|Outcome|Total|The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
190871|NCT01598987|O6|Outcome|>95% Percentile|Growth percentile category
190872|NCT01598987|O5|Outcome|>75% - 95% Percentile|Growth percentile category
190873|NCT01598987|O4|Outcome|>50% - 75% Percentile|Growth percentile categpru
190874|NCT01598987|O3|Outcome|>25% - 50% Percentile|Growth percentile category
190875|NCT01598987|O2|Outcome|>5% - 25% Percentile|Growth percentile category
190876|NCT01598987|O1|Outcome|<=5% Percentile|Growth percentile category
190877|NCT01598987|O1|Outcome|Everolimus Based Regimen|"Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).~The dosing schedule was twice daily, 12 hours apart."
190878|NCT01598987|O1|Outcome|Everolimus Based Regimen|"Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).~The dosing schedule was twice daily, 12 hours apart."
190879|NCT01598987|O1|Outcome|Everolimus Based Regimen|"Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).~The dosing schedule was twice daily, 12 hours apart."
190880|NCT01598987|E1|Reported Event|All Patients|All patients
190881|NCT01598779|B1|Baseline|Patients Having External Genital Warts|"Patients were examined by experienced ginecologists in their first visit to evaluate the presence of lesions suspicious of condilomata acuminate, If they had lesions suspicious of gential warts, they were invited to participate and given an informed consent. Biopsied from genital warts were taken with an excisional procedure under local anesthesia. Biopsied sample was splinted in order to obtain two pieces, one of them was kept in formol solution (10%) and sent to the pathology laboratory for hematoxiline - eosine paint and lecture. All biopsies were analyzed by expert pathologists in order to confirm the histological diagnosis of genital warts. The other piece was sent to the laboratory to investigate the presence of HPV 6 and 11.~In this first visit, the chronogram of activities included the detection of external genital warts, review of the criteria for inclusion and exclusion, firm informed consent, complete the questionnaire and take the biopsy, on a 2nd visit we informed the"
190882|NCT01598779|P1|Participant Flow|Patients Having External Genital Warts|"Patients were examined by experienced ginecologists in their first visit to evaluate the presence of lesions suspicious of condilomata acuminate, If they had lesions suspicious of gential warts, they were invited to participate and given an informed consent. Biopsied from genital warts were taken with an excisional procedure under local anesthesia. Biopsied sample was splinted in order to obtain two pieces, one of them was kept in formol solution (10%) and sent to the pathology laboratory for hematoxiline - eosine paint and lecture. All biopsies were analyzed by expert pathologists in order to confirm the histological diagnosis of genital warts. The other piece was sent to the laboratory to investigate the presence of HPV 6 and 11.~In this first visit, the chronogram of activities included the detection of external genital warts, review of the criteria for inclusion and exclusion, firm informed consent, complete the questionnaire and take the biopsy, on a 2nd visit we informed the"
190883|NCT01598779|O1|Outcome|Women With External Genital Warts|"Women age 15–45 attending an outpatient consultation at clinics of the investigators or at University of Buenos Aires, with a lesion suspected of being HPV related were eligible to enter in the study. The main manifestations of genital warts include cauliflower-like condylomata acuminata lesions, keratotic and smooth papular warts, subclinical flat warts, Patients previously vaccinated with commercially available vaccines (Gardasil™ or Cervarix™) were not invited to participate.~Inclusion criteria: women between 15 and 45 years old, with External Genital Warts. We will exclude women under treatment corticosteroids, having an immunosuppressive disease, pregnancy, cancer related to HPV, VIN confirmed by histology, other sexually transmitted infection, HIV+ known"
190884|NCT01598779|E1|Reported Event|Patients Having External Genital Warts|"Patients were examined by experienced ginecologists in their first visit to evaluate the presence of lesions suspicious of condilomata acuminate, If they had lesions suspicious of gential warts, they were invited to participate and given an informed consent. Biopsied from genital warts were taken with an excisional procedure under local anesthesia. Biopsied sample was splinted in order to obtain two pieces, one of them was kept in formol solution (10%) and sent to the pathology laboratory for hematoxiline - eosine paint and lecture. All biopsies were analyzed by expert pathologists in order to confirm the histological diagnosis of genital warts. The other piece was sent to the laboratory to investigate the presence of HPV 6 and 11.~In this first visit, the chronogram of activities included the detection of external genital warts, review of the criteria for inclusion and exclusion, firm informed consent, complete the questionnaire and take the biopsy, on a 2nd visit we informed the"
190885|NCT01598740|B3|Baseline|Total|Total of all reporting groups
190886|NCT01598740|B2|Baseline|CLP/CLP + Spiro|Subjects in this group received administration of CLP alone orally in Period 1/coadministration of CLP orally and spironolactone orally in Period 2.
190887|NCT01598740|B1|Baseline|CLP + Spiro/CLP|Subjects in this group received coadministration of CLP orally and spironolactone orally in Period 1/administration of CLP orally alone in Period 2.
190888|NCT01598740|P2|Participant Flow|CLP (7 Days), Washout (7 Days), CLP + Spiro (7 Days)|Subjects in this group received administration of CLP alone orally in Period 1/coadministration of CLP orally and spironolactone orally in Period 2.
190889|NCT01598740|P1|Participant Flow|CLP + Spiro (7 Days), Washout (7 Days), CLP (7 Days)|Subjects in this group received coadministration of CLP orally and spironolactone orally in Period 1/administration of CLP orally alone in Period 2.
190890|NCT01598740|O2|Outcome|Treatment Group: CLP + Spironolactone|CLP: oral administration Spironolactone: oral administration
190891|NCT01598740|O1|Outcome|Treatment Group: CLP Alone|CLP: oral administration
190892|NCT01598740|O2|Outcome|Treatment Group: CLP + Spironolactone|CLP: oral administration Spironolactone: oral administration
190893|NCT01598740|O1|Outcome|Treatment Group: CLP Alone|oral administration
190894|NCT01598740|E2|Reported Event|Treatment Group: CLP + Spironolactone|CLP: oral administration Spironolactone: oral administration
190895|NCT01598740|E1|Reported Event|Treatment Group: CLP Alone|oral administration
190896|NCT01598610|B1|Baseline|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
190897|NCT01598610|P1|Participant Flow|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
190898|NCT01598610|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
190899|NCT01598610|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
190900|NCT01598610|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
190901|NCT01598610|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
190902|NCT01598610|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
190903|NCT01598610|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
190904|NCT01598610|E1|Reported Event|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
190905|NCT01598545|B1|Baseline|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
190906|NCT01598545|P1|Participant Flow|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
190907|NCT01598545|O1|Outcome|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
190908|NCT01598545|O1|Outcome|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
190909|NCT01598545|O1|Outcome|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
190910|NCT01598545|O1|Outcome|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
190911|NCT01598545|O1|Outcome|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
190912|NCT01598545|E1|Reported Event|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
190913|NCT01598532|B1|Baseline|Transcranial LED Treatment|"All study subjects received LED treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy. Each session was 30 minutes in duration. Neuropsychological testing was administered at the following time points: within 1 week of the first LED treatment and within 1 week, 1 month & 2 months following the last LED treatment.~The neuropsychological testing included: 1)Stroop test, 2) California Verbal Learning Test-II (CVLT- II), Short Delay Free & Cued Recall, Long Delay Free & Cued Recall, 3) Delis-Kaplan Executive Function (D-KEF) -Trails Test, 4) Controlled Oral Word Association Test (FAS), & 5) Digit Span, Forwards & Backwards.~The following tests were not analyzed due to collinearity with other measures (r > .8): Short Delay Free & Cued Recall, Long Delay Cued Recall, & Delis-Kaplan Executive Function (D-KEF) -Trails Test."
190914|NCT01598532|P1|Participant Flow|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.
190915|NCT01598532|O1|Outcome|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.
194331|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
190916|NCT01598532|O1|Outcome|Transcranial LED Treatment|"All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.~MedX Health Phototherapy (light therapy): The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each."
190917|NCT01598532|O1|Outcome|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.
190918|NCT01598532|O1|Outcome|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light and laser). Each session was 30 minutes in duration.
190919|NCT01598532|O1|Outcome|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.
190920|NCT01598532|O1|Outcome|Transcranial LED Treatment|MedX Health Phototherapy (light therapy): The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each.
190921|NCT01598532|E1|Reported Event|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light and laser). Each session was 30 minutes in duration.
190922|NCT01598506|B1|Baseline|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.~ED50 of hydromorphone was 12.7 mcg +/- 3.27."
190923|NCT01598506|P1|Participant Flow|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.~ED50 of hydromorphone was 12.7 mcg +/- 3.27."
190924|NCT01598506|O1|Outcome|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.~ED50 of hydromorphone was 12.7 mcg +/- 3.27."
190925|NCT01598506|O1|Outcome|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.~ED50 of hydromorphone was 10.9 (95% CI +/- 1.2 mcg)."
190926|NCT01598506|E1|Reported Event|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.~ED50 of hydromorphone was 12.7 mcg +/- 3.27."
190927|NCT01598428|B1|Baseline|Cataract|
190928|NCT01598428|P1|Participant Flow|Cataract|During cataract surgery, the anterior capsule was unpolished intraoperatively in one eye; the anterior capsule and the equator of capsule was extensively polished intraoperatively in the other eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
190929|NCT01598428|O2|Outcome|Anterior Capsule Polishing|During cataract surgery, the anterior capsule and the equator of capsule was extensively polished intraoperatively in this eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
190930|NCT01598428|O1|Outcome|Control|During cataract surgery, the anterior capsule was unpolished intraoperatively in this eye;
190931|NCT01598428|O2|Outcome|Anterior Capsule Polishing|During cataract surgery, the anterior capsule and the equator of capsule was extensively polished intraoperatively in this eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
190932|NCT01598428|O1|Outcome|Control|During cataract surgery, the anterior capsule was unpolished intraoperatively in this eye;
190933|NCT01598428|O2|Outcome|Anterior Capsule Polishing|During cataract surgery, the anterior capsule and the equator of capsule was extensively polished intraoperatively in this eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
190934|NCT01598428|O1|Outcome|Control|During cataract surgery, the anterior capsule was unpolished intraoperatively in this eye;
190935|NCT01598428|E1|Reported Event|Cataract|
190936|NCT01598350|B1|Baseline|Orthotic|"Orthotic Use~Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial"
190937|NCT01598350|P1|Participant Flow|Orthotic|"Orthotic Use~Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial"
190938|NCT01598350|O1|Outcome|Orthotic|"Orthotic Use~Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial"
190939|NCT01598350|E1|Reported Event|Orthotic|"Orthotic Use~Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial"
190940|NCT01598311|B3|Baseline|Total|Total of all reporting groups
190941|NCT01598311|B2|Baseline|Vancomycin|Participants took vancomycin 125 mg q.i.d. by mouth for 10 days.
190942|NCT01598311|B1|Baseline|CB-183,315|Participants took CB-183,315 250 mg b.i.d. and placebo b.i.d. by mouth for 10 days.
190943|NCT01598311|P2|Participant Flow|Vancomycin|Participants took vancomycin 125 mg four times daily (q.i.d.) by mouth for 10 days.
190944|NCT01598311|P1|Participant Flow|CB-183,315|Participants took CB-183,315 250 mg twice daily (b.i.d.) and placebo b.i.d. by mouth for 10 days.
190945|NCT01598311|O2|Outcome|Vancomycin|Participants took vancomycin 125 mg q.i.d. by mouth for 10 days.
190946|NCT01598311|O1|Outcome|CB-183,315|Participants took CB-183,315 250 mg b.i.d. and placebo b.i.d. by mouth for 10 days.
190947|NCT01598311|O2|Outcome|Vancomycin|Participants took vancomycin 125 mg q.i.d. by mouth for 10 days.
190948|NCT01598311|O1|Outcome|CB-183,315|Participants took CB-183,315 250 mg b.i.d. and placebo b.i.d. by mouth for 10 days.
190949|NCT01598311|O2|Outcome|Vancomycin|Participants took vancomycin 125 mg q.i.d. by mouth for 10 days.
190950|NCT01598311|O1|Outcome|CB-183,315|Participants took CB-183,315 250 mg b.i.d. and placebo b.i.d. by mouth for 10 days.
190951|NCT01598311|O2|Outcome|Vancomycin|Participants took vancomycin 125 mg q.i.d. by mouth for 10 days.
194332|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
190952|NCT01598311|O1|Outcome|CB-183,315|Participants took CB-183,315 250 mg b.i.d. and placebo b.i.d. by mouth for 10 days.
190953|NCT01598311|O2|Outcome|Vancomycin|Participants took vancomycin 125 mg q.i.d. by mouth for 10 days.
190954|NCT01598311|O1|Outcome|CB-183,315|Participants took CB-183,315 250 mg b.i.d. and placebo b.i.d. by mouth for 10 days.
190955|NCT01598311|E2|Reported Event|Vancomycin|Participants took vancomycin 125 mg q.i.d. by mouth for 10 days.
190956|NCT01598311|E1|Reported Event|CB-183,315|Participants took CB-183,315 250 mg b.i.d. and placebo b.i.d. by mouth for 10 days.
190957|NCT01598298|B3|Baseline|Total|Total of all reporting groups
190958|NCT01598298|B2|Baseline|Arm II: Placebo|"Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91.~placebo: Given PO"
190959|NCT01598298|B1|Baseline|Arm I: Duloxetine|"Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91.~duloxetine hydrochloride: Given PO"
190960|NCT01598298|P2|Participant Flow|Arm II: Placebo|"Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91.~placebo: Given PO"
190961|NCT01598298|P1|Participant Flow|Arm I: Duloxetine|"Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91.~duloxetine hydrochloride: Given PO"
190962|NCT01598298|O2|Outcome|Arm II: Placebo|"Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91.~placebo: Given PO"
190963|NCT01598298|O1|Outcome|Arm I: Duloxetine|"Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91.~duloxetine hydrochloride: Given PO"
190964|NCT01598298|O2|Outcome|Arm II: Placebo|"Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91.~placebo: Given PO"
190965|NCT01598298|O1|Outcome|Arm I: Duloxetine|"Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91.~duloxetine hydrochloride: Given PO"
190966|NCT01598298|O2|Outcome|Arm II: Placebo|"Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91.~placebo: Given PO"
190967|NCT01598298|O1|Outcome|Arm I: Duloxetine|"Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91.~duloxetine hydrochloride: Given PO"
190968|NCT01598298|E2|Reported Event|Arm I: Duloxetine|Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91. duloxetine hydrochloride: Given PO
190969|NCT01598298|E1|Reported Event|Arm II: Placebo|Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91. placebo: Given PO
190970|NCT01598207|B3|Baseline|Total|Total of all reporting groups
190971|NCT01598207|B2|Baseline|Placebo|Placebo: 5mg BID, orally for 1 month
190972|NCT01598207|B1|Baseline|Marinol|Marinol: 5mg BID, orally for 1 month
190973|NCT01598207|P2|Participant Flow|Placebo|Placebo: 5mg BID, orally for 1 month
190974|NCT01598207|P1|Participant Flow|Marinol|Marinol: 5mg BID, orally for 1 month
190975|NCT01598207|O2|Outcome|Placebo|Placebo: 5mg BID, orally for 1 month
190976|NCT01598207|O1|Outcome|Marinol|Marinol: 5mg BID, orally for 1 month
190977|NCT01598207|O2|Outcome|Placebo|Placebo: 5mg BID, orally for 1 month
190978|NCT01598207|O1|Outcome|Marinol|Marinol: 5mg BID, orally for 1 month
190979|NCT01598207|O2|Outcome|Placebo|Placebo: 5mg BID, orally for 1 month
190980|NCT01598207|O1|Outcome|Marinol|Marinol: 5mg BID, orally for 1 month
190981|NCT01598207|O2|Outcome|Placebo|Placebo: 5mg BID, orally for 1 month
190982|NCT01598207|O1|Outcome|Marinol|Marinol: 5mg BID, orally for 1 month
190983|NCT01598207|O2|Outcome|Placebo|Placebo: 5mg BID, orally for 1 month
190984|NCT01598207|O1|Outcome|Marinol|Marinol: 5mg BID, orally for 1 month
190985|NCT01598207|O2|Outcome|Placebo|Placebo: 5mg BID, orally for 1 month
190986|NCT01598207|O1|Outcome|Marinol|Marinol: 5mg BID, orally for 1 month
190987|NCT01598207|O2|Outcome|Placebo|Placebo: 5mg BID, orally for 1 month
190988|NCT01598207|O1|Outcome|Marinol|Marinol: 5mg BID, orally for 1 month
190989|NCT01598207|E2|Reported Event|Placebo|Placebo: 5mg BID, orally for 1 month
190990|NCT01598207|E1|Reported Event|Marinol|Marinol: 5mg BID, orally for 1 month
190991|NCT01598129|B1|Baseline|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
190992|NCT01598129|P1|Participant Flow|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
190993|NCT01598129|O1|Outcome|CGTG-102|"CGTG-102 dose escalation~ONCOS-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
190994|NCT01598129|O1|Outcome|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
190995|NCT01598129|O1|Outcome|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
190996|NCT01598129|O1|Outcome|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
191067|NCT01597635|O1|Outcome|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
194333|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
190997|NCT01598129|O1|Outcome|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
190998|NCT01598129|O1|Outcome|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
190999|NCT01598129|E1|Reported Event|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
191000|NCT01598064|B3|Baseline|Total|Total of all reporting groups
191001|NCT01598064|B2|Baseline|Placebo|Placebo 1 pack tid for 8 weeks
191002|NCT01598064|B1|Baseline|GK#10|GK#10 1 pk tid for 8 weeks
191003|NCT01598064|P2|Participant Flow|Placebo|Placebo 1 pack tid for 8 weeks
191004|NCT01598064|P1|Participant Flow|GK#10|GK#10 1 pk tid for 8 weeks
191005|NCT01598064|O2|Outcome|Placebo: 8 Week|Placebo 1 pack three times per day for 8 weeks, and F/U ALT level.
191006|NCT01598064|O1|Outcome|GK#10: 8 Week|GK#10 1 pack three times per day for 8 weeks, and F/U ALT level.
191007|NCT01598064|O2|Outcome|Placebo|Placebo 1 pack tid for 8 weeks
191008|NCT01598064|O1|Outcome|GK#10|GK#10 1 pk tid for 8 weeks
191009|NCT01598064|E2|Reported Event|Placebo|Placebo 1 pack tid for 8 weeks
191010|NCT01598064|E1|Reported Event|GK#10|GK#10 1 pk tid for 8 weeks
191011|NCT01598025|B3|Baseline|Total|Total of all reporting groups
191012|NCT01598025|B2|Baseline|Regimen 2|"To be given to patients non-malignant, life-threatening diseases and patients with hematologic malignancies, with extensive prior therapy and comorbidities who are unable to receive TBI, consists of Melphalan 70mg/m2 IV x 2 days, thiotepa 5mg/kg IV x 2 days (or 10mg/kg x 1 day), and fludarabine 25 mg/m2 IV x 5 days.~TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0.~thiotepa~fludarabine phosphate~melphalan~anti-thymocyte globulin~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~laboratory biomarker analysis"
191013|NCT01598025|B1|Baseline|REGIMEN 1|"REGIMEN 1: Patients undergo hyperfractionated TBI TID for a total of 11-12 doses on days -10 to -7 and receive thiotepa IV over 4 hours QD on days -6 and -5, fludarabine phosphate IV over 30 minutes QD on days -6 to -2, and anti-thymocyte globulin IV on days -4 to -2.~TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0.~total-body irradiation (TBI)~thiotepa~fludarabine phosphate~anti-thymocyte globulin~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~laboratory biomarker analysis"
191014|NCT01598025|P2|Participant Flow|Regimen 2|"To be given to patients non-malignant, life-threatening diseases and patients with hematologic malignancies, with extensive prior therapy and comorbidities who are unable to receive TBI, consists of Melphalan 70mg/m2 IV x 2 days, thiotepa 5mg/kg IV x 2 days (or 10mg/kg x 1 day), and fludarabine 25 mg/m2 IV x 5 days.~TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0.~thiotepa~fludarabine phosphate~melphalan~anti-thymocyte globulin~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~laboratory biomarker analysis"
191015|NCT01598025|P1|Participant Flow|REGIMEN 1|"REGIMEN 1: Patients undergo hyperfractionated TBI TID for a total of 11-12 doses on days -10 to -7 and receive thiotepa IV over 4 hours QD on days -6 and -5, fludarabine phosphate IV over 30 minutes QD on days -6 to -2, and anti-thymocyte globulin IV on days -4 to -2.~TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0.~total-body irradiation (TBI)~thiotepa~fludarabine phosphate~anti-thymocyte globulin~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~laboratory biomarker analysis"
191016|NCT01598025|O2|Outcome|Regimen 2|"To be given to patients non-malignant, life-threatening diseases and patients with hematologic malignancies, with extensive prior therapy and comorbidities who are unable to receive TBI, consists of Melphalan 70mg/m2 IV x 2 days, thiotepa 5mg/kg IV x 2 days (or 10mg/kg x 1 day), and fludarabine 25 mg/m2 IV x 5 days.~TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0.~thiotepa~fludarabine phosphate~melphalan~anti-thymocyte globulin~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~laboratory biomarker analysis"
191017|NCT01598025|O1|Outcome|REGIMEN 1|"REGIMEN 1: Patients undergo hyperfractionated TBI TID for a total of 11-12 doses on days -10 to -7 and receive thiotepa IV over 4 hours QD on days -6 and -5, fludarabine phosphate IV over 30 minutes QD on days -6 to -2, and anti-thymocyte globulin IV on days -4 to -2.~TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0.~total-body irradiation (TBI)~thiotepa~fludarabine phosphate~anti-thymocyte globulin~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~laboratory biomarker analysis"
191018|NCT01598025|O2|Outcome|Regimen 2|"To be given to patients non-malignant, life-threatening diseases and patients with hematologic malignancies, with extensive prior therapy and comorbidities who are unable to receive TBI, consists of Melphalan 70mg/m2 IV x 2 days, thiotepa 5mg/kg IV x 2 days (or 10mg/kg x 1 day), and fludarabine 25 mg/m2 IV x 5 days.~TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0.~thiotepa~fludarabine phosphate~melphalan~anti-thymocyte globulin~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~laboratory biomarker analysis"
191019|NCT01598025|O1|Outcome|REGIMEN 1|"REGIMEN 1: Patients undergo hyperfractionated TBI TID for a total of 11-12 doses on days -10 to -7 and receive thiotepa IV over 4 hours QD on days -6 and -5, fludarabine phosphate IV over 30 minutes QD on days -6 to -2, and anti-thymocyte globulin IV on days -4 to -2.~TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0.~total-body irradiation (TBI)~thiotepa~fludarabine phosphate~anti-thymocyte globulin~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~laboratory biomarker analysis"
191020|NCT01598025|E2|Reported Event|Regimen 2|"To be given to patients non-malignant, life-threatening diseases and patients with hematologic malignancies, with extensive prior therapy and comorbidities who are unable to receive TBI, consists of Melphalan 70mg/m2 IV x 2 days, thiotepa 5mg/kg IV x 2 days (or 10mg/kg x 1 day), and fludarabine 25 mg/m2 IV x 5 days.~TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0.~thiotepa~fludarabine phosphate~melphalan~anti-thymocyte globulin~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~laboratory biomarker analysis"
191021|NCT01598025|E1|Reported Event|REGIMEN 1|"REGIMEN 1: Patients undergo hyperfractionated TBI TID for a total of 11-12 doses on days -10 to -7 and receive thiotepa IV over 4 hours QD on days -6 and -5, fludarabine phosphate IV over 30 minutes QD on days -6 to -2, and anti-thymocyte globulin IV on days -4 to -2.~TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0.~total-body irradiation (TBI)~thiotepa~fludarabine phosphate~anti-thymocyte globulin~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~laboratory biomarker analysis"
191022|NCT01597908|B3|Baseline|Total|Total of all reporting groups
191023|NCT01597908|B2|Baseline|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
191024|NCT01597908|B1|Baseline|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 mg orally BID and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
191025|NCT01597908|P2|Participant Flow|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
191026|NCT01597908|P1|Participant Flow|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 milligrams (mg) orally twice daily (BID) and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
191027|NCT01597908|O2|Outcome|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
191028|NCT01597908|O1|Outcome|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 mg orally BID and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
191029|NCT01597908|O2|Outcome|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
191030|NCT01597908|O1|Outcome|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 mg orally BID and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
191031|NCT01597908|O2|Outcome|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
191032|NCT01597908|O1|Outcome|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 mg orally BID and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
191033|NCT01597908|O2|Outcome|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
191034|NCT01597908|O1|Outcome|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 mg orally BID and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
191035|NCT01597908|E2|Reported Event|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
191036|NCT01597908|E1|Reported Event|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 mg orally BID and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
191037|NCT01597843|B4|Baseline|Total|Total of all reporting groups
191038|NCT01597843|B3|Baseline|Education After Data Collection Complete|This group received a similar intervention, but after all quantitative data collection complete.
191039|NCT01597843|B2|Baseline|Second Intervention Group|"The group that receives the intervention second. The intervention is the same as for the first group.~Education: Series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV."
191040|NCT01597843|B1|Baseline|First Educational Intervention Group|"Group that receives intervention first. The intervention is a series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV.~Education: Series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV."
191041|NCT01597843|P3|Participant Flow|Control First Round; Control Second Round; Intervention|Four of twelve posts were in this group and were randomized to receive a series of training sessions. The training sessions were in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV. The participants at these 4 posts received the intervention in study months 10 - 14. They completed all three survey rounds before receiving the intervention. The number of participants at any post who showed up to respond to any of the three survey rounds varied.
191068|NCT01597635|O1|Outcome|Part A|Eligible participants received multiple single intravenous escalating doses of GSK2586881 (0.1 milligrams per kg [mg/kg], 0.2 mg/kg, 0.4 mg/kg, 0.8 mg/kg) as a slow infusion over 3-5 minutes over 2 days.
191334|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
191042|NCT01597843|P2|Participant Flow|Control First Round; Education in Second Round|Four of twelve posts were in this group and were randomized to receive a series of training sessions. The training sessions were in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV. The participants at these 4 posts received the intervention in study months 6-9. They completed survey rounds 1 and 2 before receiving the intervention and survey round 3 after they received the intervention. The number of participants at any post who showed up to respond to any of the three survey rounds varied.
191043|NCT01597843|P1|Participant Flow|Education in First Round|Four of twelve posts were in this group and were randomized to receive a series of training sessions. The training sessions were in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV. The participants at these 4 posts received the intervention in study months 1-5. They completed survey round 1 before receiving the intervention and survey rounds 2 and 3 after receiving the intervention. The number of participants at any post who showed up to respond to any of the three survey rounds varied.
191044|NCT01597843|O3|Outcome|Control First Round; Control Second Round; Intervention|This group received the intervention in study months 10 - 14. They completed all three survey rounds before receiving the intervention.
191045|NCT01597843|O2|Outcome|Control First Round; Education in Second Round|The intervention was delivered to 3 groups of 4 posts in sequence. The posts in this second round received the intervention over the second study period, from month 6 through month 9. they completed survey rounds 1 and 2 before receiving the intervention, survey round 3 after.
191046|NCT01597843|O1|Outcome|Education in First Round|Series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV. This group received the intervention during study months 1-5, following survey 1, prior to survey rounds 2 and 3.
191047|NCT01597843|E3|Reported Event|Control First Round; Control Second Round; Intervention|This group received the intervention in study months 10 - 14. They completed all three survey rounds before receiving the intervention.
191048|NCT01597843|E2|Reported Event|Control First Round; Education in Second Round|The intervention was delivered to 3 groups of 4 posts in sequence. The posts in this second round received the intervention over the second study period, from month 6 through month 9. they completed survey rounds 1 and 2 before receiving the intervention, survey round 3 after.
191049|NCT01597843|E1|Reported Event|Education in First Round|Series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV. This group received the intervention during study months 1-5, following survey 1, prior to survey rounds 2 and 3.
191050|NCT01597791|B3|Baseline|Total|Total of all reporting groups
191051|NCT01597791|B2|Baseline|No Foley Catheter|"Spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals.~No foley catheter: Spontaneous Micturation/ Post Void Residual. the spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals."
191052|NCT01597791|B1|Baseline|Foley Catheter|"Control group will have a Foley catheter placed after the CSE is performed as is the usual practice at this institution.~Foley catheter: Foley catheter placement after CSE."
191053|NCT01597791|P2|Participant Flow|No Foley Catheter|"Spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals.~No foley catheter: Spontaneous Micturation/ Post Void Residual. the spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals."
191054|NCT01597791|P1|Participant Flow|Foley Catheter|"Control group will have a Foley catheter placed after the CSE is performed as is the usual practice at this institution.~Foley catheter: Foley catheter placement after CSE."
191055|NCT01597791|O2|Outcome|No Foley Catheter|"Spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals.~No foley catheter: Spontaneous Micturation/ Post Void Residual. the spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals."
191056|NCT01597791|O1|Outcome|Foley Catheter|"Control group will have a Foley catheter placed after the CSE is performed as is the usual practice at this institution.~Foley catheter: Foley catheter placement after CSE."
191057|NCT01597791|E2|Reported Event|No Foley Catheter|"Spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals.~No foley catheter: Spontaneous Micturation/ Post Void Residual. the spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals."
191058|NCT01597791|E1|Reported Event|Foley Catheter|"Control group will have a Foley catheter placed after the CSE is performed as is the usual practice at this institution.~Foley catheter: Foley catheter placement after CSE."
191059|NCT01597635|B4|Baseline|Total|Total of all reporting groups
191060|NCT01597635|B3|Baseline|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191061|NCT01597635|B2|Baseline|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
191062|NCT01597635|B1|Baseline|Part A|Eligible participants received multiple single intravenous escalating doses of GSK2586881 (0.1 mg/kg, 0.2 mg/kg, 0.4 mg/kg, 0.8 mg/kg) as a slow infusion over 3-5 minutes over 2 days.
191063|NCT01597635|P3|Participant Flow|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191064|NCT01597635|P2|Participant Flow|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) twice daily (BID) as a slow infusion over 3-5 minutes for 3 days.
191065|NCT01597635|P1|Participant Flow|Part A|Eligible participants received multiple single intravenous escalating doses of GSK2586881 (0.1 milligrams per kilograms [mg/kg], 0.2 mg/kg, 0.4 mg/kg, 0.8 mg/kg) as a slow infusion over 3-5 minutes over 2 days.
191066|NCT01597635|O2|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191069|NCT01597635|O2|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191070|NCT01597635|O1|Outcome|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
191071|NCT01597635|O2|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191072|NCT01597635|O1|Outcome|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
191073|NCT01597635|O2|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191074|NCT01597635|O1|Outcome|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
191075|NCT01597635|O2|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191076|NCT01597635|O1|Outcome|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
191077|NCT01597635|O2|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191078|NCT01597635|O1|Outcome|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
191079|NCT01597635|O2|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191080|NCT01597635|O1|Outcome|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
191081|NCT01597635|O2|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191082|NCT01597635|O1|Outcome|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
191083|NCT01597635|O2|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191084|NCT01597635|O1|Outcome|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
191085|NCT01597635|O2|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191086|NCT01597635|O1|Outcome|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
191087|NCT01597635|O2|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191088|NCT01597635|O1|Outcome|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
191089|NCT01597635|O1|Outcome|Part A|Eligible participants received multiple single intravenous escalating doses of GSK2586881 (0.1 milligrams per kg [mg/kg], 0.2 mg/kg, 0.4 mg/kg, 0.8 mg/kg) as a slow infusion over 3-5 minutes over 2 days.
191090|NCT01597635|O1|Outcome|Part A|Eligible participants received multiple single intravenous escalating doses of GSK2586881 (0.1 milligrams per kg [mg/kg], 0.2 mg/kg, 0.4 mg/kg, 0.8 mg/kg) as a slow infusion over 3-5 minutes over 2 days.
191091|NCT01597635|O1|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191092|NCT01597635|O1|Outcome|Part A|Eligible participants received multiple single intravenous escalating doses of GSK2586881 (0.1 milligrams per kg [mg/kg], 0.2 mg/kg, 0.4 mg/kg, 0.8 mg/kg) as a slow infusion over 3-5 minutes over 2 days.
191093|NCT01597635|O1|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191094|NCT01597635|O1|Outcome|Part A|Eligible participants received multiple single intravenous escalating doses of GSK2586881 (0.1 milligrams per kg [mg/kg], 0.2 mg/kg, 0.4 mg/kg, 0.8 mg/kg) as a slow infusion over 3-5 minutes over 2 days.
191095|NCT01597635|O2|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191096|NCT01597635|O1|Outcome|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
191097|NCT01597635|O1|Outcome|Part A|Eligible participants received multiple single intravenous escalating doses of GSK2586881 (0.1 milligrams per kg [mg/kg], 0.2 mg/kg, 0.4 mg/kg, 0.8 mg/kg) as a slow infusion over 3-5 minutes over 2 days.
191098|NCT01597635|O2|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191099|NCT01597635|O1|Outcome|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
191100|NCT01597635|O2|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191101|NCT01597635|O1|Outcome|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
191102|NCT01597635|O2|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191103|NCT01597635|O1|Outcome|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
191104|NCT01597635|O2|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191105|NCT01597635|O1|Outcome|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
191106|NCT01597635|O2|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191107|NCT01597635|O1|Outcome|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
191108|NCT01597635|O2|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191109|NCT01597635|O1|Outcome|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
191110|NCT01597635|O2|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191111|NCT01597635|O1|Outcome|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
191112|NCT01597635|O2|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191113|NCT01597635|O1|Outcome|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
191114|NCT01597635|O2|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191115|NCT01597635|O1|Outcome|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
191116|NCT01597635|O2|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191117|NCT01597635|O1|Outcome|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
191118|NCT01597635|O2|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191119|NCT01597635|O1|Outcome|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
191120|NCT01597635|O2|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191121|NCT01597635|O1|Outcome|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
191122|NCT01597635|O2|Outcome|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191123|NCT01597635|O1|Outcome|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
191124|NCT01597635|E3|Reported Event|Part B (GSK2586881 BID)|Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.
191125|NCT01597635|E2|Reported Event|Part B (Placebo BID)|Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.
191126|NCT01597635|E1|Reported Event|Part A|Eligible participants received multiple single intravenous escalating doses of GSK2586881 (0.1 mg/kg, 0.2 mg/kg, 0.4 mg/kg, 0.8 mg/kg) as a slow infusion over 3-5 minutes over 2 days.
191127|NCT01597596|B3|Baseline|Total|Total of all reporting groups
191128|NCT01597596|B2|Baseline|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
191129|NCT01597596|B1|Baseline|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
191130|NCT01597596|P2|Participant Flow|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
191131|NCT01597596|P1|Participant Flow|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg intravenous (IV) infusion every other week (QOW) for 52 weeks.
191132|NCT01597596|O2|Outcome|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
191133|NCT01597596|O1|Outcome|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
191134|NCT01597596|O2|Outcome|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
191135|NCT01597596|O1|Outcome|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
191136|NCT01597596|O2|Outcome|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
191137|NCT01597596|O1|Outcome|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
191138|NCT01597596|O2|Outcome|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
191139|NCT01597596|O1|Outcome|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
191140|NCT01597596|E2|Reported Event|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
191141|NCT01597596|E1|Reported Event|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
191142|NCT01597505|B3|Baseline|Total|Total of all reporting groups
191143|NCT01597505|B2|Baseline|Vancomycin|125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
191144|NCT01597505|B1|Baseline|Surotomycin|250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over encapsulated tablet administered orally, twice daily for 10 days
191145|NCT01597505|P2|Participant Flow|Vancomycin|125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
191146|NCT01597505|P1|Participant Flow|Surotomycin|250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over encapsulated tablet administered orally, twice daily for 10 days
191147|NCT01597505|O2|Outcome|Vancomycin|125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
191148|NCT01597505|O1|Outcome|Surotomycin|250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days
191149|NCT01597505|O2|Outcome|Vancomycin|125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
191150|NCT01597505|O1|Outcome|Surotomycin|250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days
191151|NCT01597505|O2|Outcome|Vancomycin|125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
191152|NCT01597505|O1|Outcome|Surotomycin|250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days
191153|NCT01597505|O2|Outcome|Vancomycin|125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
191154|NCT01597505|O1|Outcome|Surotomycin|250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days
191155|NCT01597505|O2|Outcome|Vancomycin|125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
191156|NCT01597505|O1|Outcome|Surotomycin|250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over encapsulated tablet administered orally, twice daily for 10 days
191157|NCT01597505|O2|Outcome|Vancomycin|125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
191158|NCT01597505|O1|Outcome|Surotomycin|250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over encapsulated tablet administered orally, twice daily for 10 days
191159|NCT01597505|O2|Outcome|Vancomycin|125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
191160|NCT01597505|O1|Outcome|Surotomycin|250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days
191161|NCT01597505|O2|Outcome|Vancomycin|125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
191162|NCT01597505|O1|Outcome|Surotomycin|250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days
191163|NCT01597505|O2|Outcome|Vancomycin|125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
191164|NCT01597505|O1|Outcome|Surotomycin|250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days
191165|NCT01597505|O2|Outcome|Vancomycin|125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
191166|NCT01597505|O1|Outcome|Surotomycin|250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days
191167|NCT01597505|O2|Outcome|Vancomycin|125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
191168|NCT01597505|O1|Outcome|Surotomycin|250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days
191169|NCT01597505|O2|Outcome|Vancomycin|125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
191170|NCT01597505|O1|Outcome|Surotomycin|250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over encapsulated tablet administered orally, twice daily for 10 days
191171|NCT01597505|O2|Outcome|Vancomycin|125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
191172|NCT01597505|O1|Outcome|Surotomycin|250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over encapsulated tablet administered orally, twice daily for 10 days
191173|NCT01597505|O2|Outcome|Vancomycin|125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
191174|NCT01597505|O1|Outcome|Surotomycin|250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days
191175|NCT01597505|E2|Reported Event|Vancomycin|125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
191176|NCT01597505|E1|Reported Event|Surotomycin|250 mg Surotomycin over-encapsulated tablet administered orally, twice daily for a daily total dose of 500 for 10 days
191177|NCT01597492|B3|Baseline|Total|Total of all reporting groups
191178|NCT01597492|B2|Baseline|Belimumab Plus Late Vaccination|Participants received pneumococcal vaccination on Day 168 (Week 24). Open-label belimumab 10 mg/kg IV was dosed on Days 0, 14, 28, and every 28 days thereafter until Week 28 (a total of 9 doses) plus standard therapy for SLE.
191179|NCT01597492|B1|Baseline|Belimumab Plus Early Vaccination|Participants received pneumococcal vaccination on Day 0, 4 weeks prior to the first dose of belimumab. Open-label belimumab 10 mg/kg IV was dosed on Days 28, 42, 56, and every 28 days thereafter until Week 32 (a total of 9 doses) plus standard therapy for SLE.
191180|NCT01597492|P2|Participant Flow|Belimumab Plus Late Vaccination|Participants received pneumococcal vaccination on Day 168 (Week 24). Open-label belimumab 10 mg/kg IV was dosed on Days 0, 14, 28, and every 28 days thereafter until Week 28 (a total of 9 doses) plus standard therapy for SLE.
191181|NCT01597492|P1|Participant Flow|Belimumab Plus Early Vaccination|Participants received pneumococcal vaccination on Day 0, 4 weeks prior to the first dose of belimumab. Open-label belimumab 10 mg/kg IV was dosed on Days 28, 42, 56, and every 28 days thereafter until Week 32 (a total of 9 doses) plus standard therapy for SLE.
191207|NCT01597245|B5|Baseline|Total|Total of all reporting groups
191182|NCT01597492|O2|Outcome|Belimumab Plus Late Vaccination|Participants received pneumococcal vaccination on Day 168 (Week 24). Open-label belimumab 10 mg/kg IV was dosed on Days 0, 14, 28, and every 28 days thereafter until Week 28 (a total of 9 doses) plus standard therapy for SLE.
191183|NCT01597492|O1|Outcome|Belimumab Plus Early Vaccination|Participants received pneumococcal vaccination on Day 0, 4 weeks prior to the first dose of belimumab. Open-label belimumab 10 mg/kg IV was dosed on Days 28, 42, 56, and every 28 days thereafter until Week 32 (a total of 9 doses) plus standard therapy for SLE.
191184|NCT01597492|E2|Reported Event|Belimumab Plus Late Vaccination|Belimumab plus Late Vaccination
191185|NCT01597492|E1|Reported Event|Belimumab Plus Early Vaccination|Belimumab plus Early Vaccination
191186|NCT01597479|B3|Baseline|Total|Total of all reporting groups
191187|NCT01597479|B2|Baseline|Non dPNBs Group|Non intervention in postoperative period
191188|NCT01597479|B1|Baseline|dPNBs Group|dPNBs on radial and median nerves at the elbow in postoperative period, before discharge
191189|NCT01597479|P2|Participant Flow|No Intervention (no dPNBs Group)|In patients of no dPNBs group didn't performed any intervention after surgery.
191190|NCT01597479|P1|Participant Flow|Distal Peripheral Nerve Blocks Group (dPNBs Group)|"In dPNBs group, we practice distal peripheral nerves blocks guided by ultrasound and neurostimulator.~Levobupivacaine: In dPNBs group, we practice ultrasound guided distal peripheral nerve blocks on radial and median nerves using low volume and low concentration of long acting local anesthetic (0.125% levobupivacaine, 5 ml per nerve).~We performed dPNBs in the postoperative period. Deffered dPNBs under the influence of axillary block didn't cause patient disconfort. We considered the technique safety due to ultrasound guidance."
191191|NCT01597479|O2|Outcome|Non dPNBs Group|In this group any intervention was done.
191192|NCT01597479|O1|Outcome|dPNBs Group|we practiced ultrasound guided dPNBs on radial and median nerves using a long acting and low concentration local anesthetic (0.125% levobupivacaine, 5 ml per nerve).
191193|NCT01597479|O2|Outcome|Non Distal Peripheral Nerve Blocks (Non dPNBs Group)|Patients in non dPNBs didn't received any intervention in the postoperatively period.
191194|NCT01597479|O1|Outcome|Distal Peripheral Nerve Blocks Group (dPNBs Group)|"We practiced ultrasound guided dPNBs on radial and median nerves, after surgery, before discharge.~Distal median nerve block was performed at the elbow, in the internal bicipital channel.~Distal radial nerve block was performed at approximately the junction of the middle and distal thirds of the arm.~We use 5ml per nerve of levobupivacaine 0,125% for target nerve blocks."
191195|NCT01597479|E1|Reported Event|Distal Peripheral Nerve Block Group|Any patient undergoing ultrasound guided distal peripheral nerve block reported any complication.
191196|NCT01597440|B3|Baseline|Total|Total of all reporting groups
191197|NCT01597440|B2|Baseline|Placebo|"Standard of Care therapy~Standard of Care: Standard of Care"
191198|NCT01597440|B1|Baseline|Carbaglu|"Active NCG & Standard of Care~N-carbamylglutamate: Active NCG & Standard of Care Chemical Composition: N-carbamyl-L-glutamic acid (NCG) The daily dose will be 100 mg/kg/ day. The doses are to be divided into 2 equal doses and administered orally or enterally by nasogastric or gastrostomy tube (standard of care will prevail when choosing the mode of drug administration).~The tablets must be dispersed in a minimum of 2.5-10 ml of water and ingested immediately or administered by fast push through a syringe via a nasogastric or gastrostomy tube. The suspension has a slightly acidic taste.~This drug will be administered for 7 days after admission or until discharge (whichever is sooner).~Standard of Care: Standard of Care"
191199|NCT01597440|P2|Participant Flow|Placebo|"Standard of Care therapy~Standard of Care: Standard of Care"
191200|NCT01597440|P1|Participant Flow|Carbaglu|"Active NCG & Standard of Care~N-carbamylglutamate: Active NCG & Standard of Care Chemical Composition: N-carbamyl-L-glutamic acid (NCG) The daily dose will be 100 mg/kg/ day. The doses are to be divided into 2 equal doses and administered orally or enterally by nasogastric or gastrostomy tube (standard of care will prevail when choosing the mode of drug administration).~The tablets must be dispersed in a minimum of 2.5-10 ml of water and ingested immediately or administered by fast push through a syringe via a nasogastric or gastrostomy tube. The suspension has a slightly acidic taste.~This drug will be administered for 7 days after admission or until discharge (whichever is sooner).~Standard of Care: Standard of Care"
191201|NCT01597440|O2|Outcome|Placebo|"Standard of Care Therapy~Standard of Care: Standard of Care"
191202|NCT01597440|O1|Outcome|Carbaglu|"Active NCG & Standard of Care~N-carbamylglutamate: Active NCG & Standard of Care Chemical Composition: N-carbamyl-L-glutamic acid (NCG)~The daily dose will be 100 mg/kg/ day. The doses are to be divided into 2 equal doses and administered orally or enterally by nasogastric or gastrostomy tube (standard of care will prevail when choosing the mode of drug administration).~The tablets must be dispersed in a minimum of 2.5-10 ml of water and ingested immediately or administered by fast push through a syringe via a nasogastric or gastrostomy tube. The suspension has a slightly acidic taste.~This drug will be administered for 7 days after admission or until discharge (whichever is sooner).~Standard of Care: Standard of Care"
191203|NCT01597440|O2|Outcome|Placebo|"Standard of Care therapy~Standard of Care: Standard of Care"
191204|NCT01597440|O1|Outcome|Carbaglu|"Active NCG & Standard of Care~N-carbamylglutamate: Active NCG & Standard of Care Chemical Composition: N-carbamyl-L-glutamic acid (NCG) The daily dose will be 100 mg/kg/ day. The doses are to be divided into 2 equal doses and administered orally or enterally by nasogastric or gastrostomy tube (standard of care will prevail when choosing the mode of drug administration).~The tablets must be dispersed in a minimum of 2.5-10 ml of water and ingested immediately or administered by fast push through a syringe via a nasogastric or gastrostomy tube. The suspension has a slightly acidic taste.~This drug will be administered for 7 days after admission or until discharge (whichever is sooner).~Standard of Care: Standard of Care"
191205|NCT01597440|E2|Reported Event|Placebo|"Standard of Care therapy~Standard of Care: Standard of Care"
191206|NCT01597440|E1|Reported Event|Carbaglu|"Active NCG & Standard of Care~N-carbamylglutamate: Active NCG & Standard of Care Chemical Composition: N-carbamyl-L-glutamic acid (NCG) The daily dose will be 100 mg/kg/ day. The doses are to be divided into 2 equal doses and administered orally or enterally by nasogastric or gastrostomy tube (standard of care will prevail when choosing the mode of drug administration).~The tablets must be dispersed in a minimum of 2.5-10 ml of water and ingested immediately or administered by fast push through a syringe via a nasogastric or gastrostomy tube. The suspension has a slightly acidic taste.~This drug will be administered for 7 days after admission or until discharge (whichever is sooner).~Standard of Care: Standard of Care"
191208|NCT01597245|B4|Baseline|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191209|NCT01597245|B3|Baseline|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191210|NCT01597245|B2|Baseline|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
191211|NCT01597245|B1|Baseline|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
191212|NCT01597245|P13|Participant Flow|Ixe Q2W Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q2W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
191213|NCT01597245|P12|Participant Flow|Ixe Q4W Non-Resp/Ixe Q4W- Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q4W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
191214|NCT01597245|P11|Participant Flow|ETN NonResp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received ETN in Induction Period (Weeks 0 to 12) and classified as non-responders were administered 2 SC injections of placebo at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
191215|NCT01597245|P10|Participant Flow|ETN Resp/Placebo Maintenance Period Secondary Pop|Participants who received ETN during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
191216|NCT01597245|P9|Participant Flow|Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
191217|NCT01597245|P8|Participant Flow|Placebo Resp/Placebo - Maintenance Period Secondary Pop|Participants who received placebo during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
191218|NCT01597245|P7|Participant Flow|Ixe/Ixe Q4W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
191219|NCT01597245|P6|Participant Flow|Ixe/Ixe Q12W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56. To maintain blinding with Q4W dose regimen, Placebo for ixe given as 1 SC injection at every 4 weeks from Week 16 through Week 56.
191220|NCT01597245|P5|Participant Flow|Ixe/Placebo- Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
191221|NCT01597245|P4|Participant Flow|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12
191222|NCT01597245|P3|Participant Flow|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W:Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191223|NCT01597245|P2|Participant Flow|50 mg Etanercept (ETN) - Induction Period|50 milligrams (mg) ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
191224|NCT01597245|P1|Participant Flow|Placebo- Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
191225|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191226|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191227|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
191228|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
191229|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191330|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
191230|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191231|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
191232|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
191233|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191234|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191235|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
191236|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
191237|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191238|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191239|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
191240|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
191241|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191242|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191243|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
191244|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
191245|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191246|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191247|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
191248|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
191249|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191250|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191251|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
191252|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
191253|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191331|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
191254|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191255|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
191256|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
191257|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191258|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191259|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
191260|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
191261|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191262|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191263|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
191264|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
191265|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191266|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191267|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
191268|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
191269|NCT01597245|O3|Outcome|Ixe/Ixe Q4W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
191270|NCT01597245|O2|Outcome|Ixe/Ixe Q12W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56. To maintain blinding with Q4W dose regimen, placebo for ixe given as 1 SC injection at every 4 weeks from Week 16 through Week 56 .
191271|NCT01597245|O1|Outcome|Ixe/Placebo- Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
191272|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191273|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191274|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
191275|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
191276|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191332|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
191277|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191278|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
191279|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
191280|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191281|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191282|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
191283|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections Q2W up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
191284|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191285|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191286|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
191287|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
191288|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191289|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191290|NCT01597245|O2|Outcome|50 mg Etanercept (ETN) - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
191291|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections Q2W up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
191292|NCT01597245|E14|Reported Event|Ixe Q4W Maintenance Period Relapsed Pop|Participants who relapsed (loss of response, sPGA ≥3 during Maintenance Period) were administered 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
191293|NCT01597245|E13|Reported Event|Ixe Q2W NonResp/Ixe Q4W Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q2W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
191294|NCT01597245|E12|Reported Event|Ixe Q4W Non-Resp/Ixe Q4W- Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q4W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
191295|NCT01597245|E11|Reported Event|ETN NonResp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received ETN in Induction Period (Weeks 0 to 12) and classified as non-responders were administered 2 SC injections of placebo at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
191296|NCT01597245|E10|Reported Event|ETN Resp/Placebo Maintenance Period Secondary Pop|Participants who received ETN during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
191297|NCT01597245|E9|Reported Event|Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
191298|NCT01597245|E8|Reported Event|Placebo Resp/Placebo - Maintenance Period Secondary Pop|Participants who received placebo during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
191299|NCT01597245|E7|Reported Event|Ixe/Ixe Q4W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
191333|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
191300|NCT01597245|E6|Reported Event|Ixe/Ixe Q12W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56. To maintain blinding with Q4W dose regimen, Placebo for ixe given as 1 SC injection at every 4 weeks from Week 16 through Week 56.
191301|NCT01597245|E5|Reported Event|Ixe/Placebo- Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
191302|NCT01597245|E4|Reported Event|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191303|NCT01597245|E3|Reported Event|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W): (Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
191304|NCT01597245|E2|Reported Event|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
191305|NCT01597245|E1|Reported Event|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections Q2W up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
191306|NCT01597141|B3|Baseline|Total|Total of all reporting groups
191307|NCT01597141|B2|Baseline|Enhanced Treatment|"In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.~Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention"
191308|NCT01597141|B1|Baseline|Family-aided ACT|"The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.~Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication."
191309|NCT01597141|P2|Participant Flow|Enhanced Treatment|"In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.~Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention"
191310|NCT01597141|P1|Participant Flow|Family-aided ACT|"The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.~Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication."
191311|NCT01597141|O2|Outcome|Enhanced Standard Treatment|"In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.~Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention"
191312|NCT01597141|O1|Outcome|Family-aided Assertive Community Treatment|"The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.~Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication."
191313|NCT01597141|O2|Outcome|Enhanced Treatment|"In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.~Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention"
191314|NCT01597141|O1|Outcome|Family-aided ACT|"The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.~Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication."
191315|NCT01597141|E2|Reported Event|Enhanced Standard Treatment|In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.
191316|NCT01597141|E1|Reported Event|Family-aided Assertive Community Treatment|The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.
191317|NCT01597128|B3|Baseline|Total|Total of all reporting groups
191318|NCT01597128|B2|Baseline|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
191319|NCT01597128|B1|Baseline|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
191320|NCT01597128|P2|Participant Flow|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
191321|NCT01597128|P1|Participant Flow|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
191322|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
191323|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
191324|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
191325|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
191326|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
191327|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
191328|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
191329|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
191335|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
191336|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
191337|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
191338|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
191339|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
191340|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
191341|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
191342|NCT01597128|E2|Reported Event|Strattice|"Use of a second mesh type~Strattice: Strattice mash for hernia repair"
191343|NCT01597128|E1|Reported Event|Flex HD|"Mesh Type~Flex HD: Flex HD mesh for hernia repair"
191344|NCT01597050|B3|Baseline|Total|Total of all reporting groups
191345|NCT01597050|B2|Baseline|Placebo|"Placebo, bid~Placebo: Placebo, bid"
191346|NCT01597050|B1|Baseline|Drug: R932333|"R333 6% (60 mg/g), bid~R932333: R393233 6% (60 mg/g), bid"
191347|NCT01597050|P2|Participant Flow|Placebo|"Placebo, bid~Placebo: Placebo, bid"
191348|NCT01597050|P1|Participant Flow|Drug: R932333|"R333 6% (60 mg/g), bid~R932333: R393233 6% (60 mg/g), bid"
191349|NCT01597050|O2|Outcome|Placebo|"Placebo, bid~Placebo: Placebo, bid"
191350|NCT01597050|O1|Outcome|Drug: R932333|"R333 6% (60 mg/g), bid~R932333: R393233 6% (60 mg/g), bid"
191351|NCT01597050|E2|Reported Event|Placebo|"Placebo, bid~Placebo: Placebo, bid"
191352|NCT01597050|E1|Reported Event|Drug: R932333|"R333 6% (60 mg/g), bid~R932333: R393233 6% (60 mg/g), bid"
191353|NCT01596972|B3|Baseline|Total|Total of all reporting groups
191354|NCT01596972|B2|Baseline|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
191355|NCT01596972|B1|Baseline|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week~dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
191356|NCT01596972|P2|Participant Flow|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
191357|NCT01596972|P1|Participant Flow|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week~dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
191358|NCT01596972|O2|Outcome|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
191359|NCT01596972|O1|Outcome|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week~dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
191360|NCT01596972|O2|Outcome|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
191361|NCT01596972|O1|Outcome|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week~dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
191362|NCT01596972|O2|Outcome|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
191380|NCT01596582|P2|Participant Flow|Risk Assessment|"Subjects randomized to the experimental arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) and the ACNI risk assessment tool just prior to a scheduled office visit with their provider.~Risk Assessment: Patients randomized to the experimental arm will be asked a complete the ACNI risk assessment tool after reviewing a web-based colorectal cancer decision aid The ACNI uses a point based system to stratify patients into low (mean rate of ACN ~3%)versus intermediate/high (~ 8%) risk groups based on responses to 6 items: age 50-59,60-69, 70+), sex (male/female), race/ethnicity (non-Hispanic black, other), smoking history (never, <20 years, >20 years), daily alcohol intake (< 2 vs. >/=2 drinks) and use of non-steroidal anti-inflammatory drugs (ever, never)."
191363|NCT01596972|O1|Outcome|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week~dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
191364|NCT01596972|E2|Reported Event|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
191365|NCT01596972|E1|Reported Event|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week~dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
191366|NCT01596842|B3|Baseline|Total|Total of all reporting groups
191367|NCT01596842|B2|Baseline|Olive Oil|"Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
191368|NCT01596842|B1|Baseline|Omega-3 Fatty Acid|"Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
191369|NCT01596842|P2|Participant Flow|Olive Oil|"Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
191370|NCT01596842|P1|Participant Flow|Omega-3 Fatty Acid|"Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
191371|NCT01596842|O2|Outcome|Olive Oil|"Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
191372|NCT01596842|O1|Outcome|Omega-3 Fatty Acid|"Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
191373|NCT01596842|O2|Outcome|Olive Oil|"Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
191374|NCT01596842|O1|Outcome|Omega-3 Fatty Acid|"Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
191375|NCT01596842|E2|Reported Event|Olive Oil|"Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
191376|NCT01596842|E1|Reported Event|Omega-3 Fatty Acid|"Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
191377|NCT01596582|B3|Baseline|Total|Total of all reporting groups
191378|NCT01596582|B2|Baseline|Risk Assessment|"Subjects randomized to the experimental arm completed the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.~Risk Assessment: Patients randomized to the experimental arm will be asked a complete the ACNI risk assessment tool after reviewing a web-based colorectal cancer decision aid The ACNI uses a point based system to stratify patients into low (mean rate of ACN ~3%)versus intermediate/high (~ 8%) risk groups based on responses to 6 items: age 50-59,60-69, 70+), sex (male/female), race/ethnicity (non-Hispanic black, other), smoking history (never, <20 years, >20 years), daily alcohol intake (< 2 vs. >/=2 drinks) and use of non-steroidal anti-inflammatory drugs (ever, never)."
191379|NCT01596582|B1|Baseline|Standard Care|Subjects randomized to the control arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled visit with their provider.
191381|NCT01596582|P1|Participant Flow|Standard Care|Subjects randomized to the control arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled visit with their provider.
191382|NCT01596582|O2|Outcome|Low Risk|Patients with cumulative scores of less than 5 were classified as low risk, with a mean ACN rate of 3.1% (95% confidence interval [CI], 2.4% - 24.1%).
191501|NCT01596062|B3|Baseline|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
191383|NCT01596582|O1|Outcome|High Risk|Patients with cumulative ACNI scores of 5 to 12 were classified as intermediate/high risk (hereafter referred to as high risk), with a mean ACN rate of 8.3% (95% CI, 7.1% - 29.6%)
191384|NCT01596582|O2|Outcome|Low Risk|Patients with cumulative scores of less than 5 were classified as low risk, with a mean ACN rate of 3.1% (95% confidence interval [CI], 2.4% - 24.1%).
191385|NCT01596582|O1|Outcome|High Risk|Patients with cumulative ACNI scores of 5 to 12 were classified as intermediate/high risk (hereafter referred to as high risk), with a mean ACN rate of 8.3% (95% CI, 7.1% - 29.6%)
191386|NCT01596582|O2|Outcome|Risk Assessment|Subjects randomized to the experimental arm completed the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
191387|NCT01596582|O1|Outcome|Standard Care|Subjects randomized to the experimental arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
191388|NCT01596582|O2|Outcome|Risk Assessment|Subjects randomized to the experimental arm completed the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
191389|NCT01596582|O1|Outcome|Standard Care|Subjects randomized to the experimental arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
191390|NCT01596582|O2|Outcome|Posttest|Provider responses to the same 3-item posttest administered after completion of study enrollment. Provider responses to a 3-item pretest administered prior the commencement of the study.
191391|NCT01596582|O1|Outcome|Pretest|Provider responses to a 3-item pretest administered prior the commencement of the study.
191392|NCT01596582|O2|Outcome|Discordance|The subgroup of patients who had a non-preferred test ordered, regardless of study arm or risk-category.
191393|NCT01596582|O1|Outcome|Concordance|The subgroup of patients who had their preferred test ordered, regardless of study arm or risk-category.
191394|NCT01596582|O2|Outcome|Discordance|The subgroup of patients who had a non-preferred test ordered, regardless of study arm or risk-category.
191395|NCT01596582|O1|Outcome|Concordance|The subgroup of patients who had their preferred test ordered, regardless of study arm or risk-category.
191396|NCT01596582|O2|Outcome|Discordance|The subgroup of patients who had a non-preferred test ordered, regardless of study arm or risk-category.
191397|NCT01596582|O1|Outcome|Concordance|The subgroup of patients who had their preferred test ordered, regardless of study arm or risk-category.
191398|NCT01596582|O2|Outcome|Low Risk|Patients with cumulative scores of less than 5 were classified as low risk, with a mean ACN rate of 3.1% (95% confidence interval [CI], 2.4% - 24.1%).
191399|NCT01596582|O1|Outcome|High Risk|Patients with cumulative ACNI scores of 5 to 12 were classified as intermediate/high risk (hereafter referred to as high risk), with a mean ACN rate of 8.3% (95% CI, 7.1% - 29.6%)
191400|NCT01596582|O2|Outcome|Risk Assessment|Subjects randomized to the experimental arm completed the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
191401|NCT01596582|O1|Outcome|Standard Care|Subjects randomized to the standard care arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
191402|NCT01596582|E2|Reported Event|Risk Assessment|Subjects randomized to the experimental arm will complete the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
191403|NCT01596582|E1|Reported Event|Standard Care|Subjects randomized to the experimental arm will review the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
191404|NCT01596504|B4|Baseline|Total|Total of all reporting groups
191405|NCT01596504|B3|Baseline|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
191406|NCT01596504|B2|Baseline|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
191407|NCT01596504|B1|Baseline|Lixisenatide 20 μg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
191408|NCT01596504|P3|Participant Flow|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
191409|NCT01596504|P2|Participant Flow|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
191410|NCT01596504|P1|Participant Flow|Lixisenatide 20 μg|Subcutaneous injection of lixisenatide10 μg once daily (QD) for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
191411|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
191412|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
191413|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
191414|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
191415|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
191416|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
191496|NCT01596088|B1|Baseline|Dexrazoxane|
191497|NCT01596088|P1|Participant Flow|Dexrazoxane|
191417|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
191418|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
191419|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
191420|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
191421|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
191422|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
191423|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
191424|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
191425|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
191426|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
191427|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
191428|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
191429|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
191430|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
191431|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
191432|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
191433|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
191434|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
191435|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
191436|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
191437|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
191438|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
191439|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
191440|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
191441|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
191442|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
191443|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
191444|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
191445|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
191446|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
191447|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
191448|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
191449|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
191498|NCT01596088|O1|Outcome|Dexrazoxane|
191499|NCT01596088|E1|Reported Event|Dexrazoxane|
191450|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
191451|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
191452|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
191453|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
191454|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
191455|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
191456|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
191457|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
191458|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
191459|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
191460|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
191461|NCT01596504|O1|Outcome|Lixisenatide 20 μg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
191462|NCT01596504|E3|Reported Event|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
191463|NCT01596504|E2|Reported Event|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
191464|NCT01596504|E1|Reported Event|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
191465|NCT01596283|B3|Baseline|Total|Total of all reporting groups
191466|NCT01596283|B2|Baseline|Standard Perioperative Resuscitation|
191467|NCT01596283|B1|Baseline|Goal-directed Therapy|
191468|NCT01596283|P2|Participant Flow|Standard Perioperative Resuscitation After Liver Resection|Patients who undergo an open, elective liver resection, Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures.
191469|NCT01596283|P1|Participant Flow|Goal-directed Therapy (GDT) After Liver Resection|Patients who undergo an open, elective liver resection, Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures. Goal-directed therapy (GDT) embodies a number of physiologic strategies to achieve an ideal fluid balance and avoid the consequences of over- or under-resuscitation.
191470|NCT01596283|O2|Outcome|Standard Perioperative Resuscitation After Liver Resection|Patients who undergo an open, elective liver resection, Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures.
191471|NCT01596283|O1|Outcome|Goal-directed Therapy (GDT) After Liver Resection|Patients who undergo an open, elective liver resection, Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures. Goal-directed therapy (GDT) embodies a number of physiologic strategies to achieve an ideal fluid balance and avoid the consequences of over- or under-resuscitation.
191472|NCT01596283|O2|Outcome|Standard Perioperative Resuscitation After Liver Resection|Patients who undergo an open, elective liver resection, Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures.
191473|NCT01596283|O1|Outcome|Goal-directed Therapy (GDT) After Liver Resection|Patients who undergo an open, elective liver resection, Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures. Goal-directed therapy (GDT) embodies a number of physiologic strategies to achieve an ideal fluid balance and avoid the consequences of over- or under-resuscitation.
191474|NCT01596283|O2|Outcome|Standard Perioperative Resuscitation After Liver Resection|Patients who undergo an open, elective liver resection, Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures.
191475|NCT01596283|O1|Outcome|Goal-directed Therapy (GDT) After Liver Resection|Patients who undergo an open, elective liver resection, Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures. Goal-directed therapy (GDT) embodies a number of physiologic strategies to achieve an ideal fluid balance and avoid the consequences of over- or under-resuscitation.
191476|NCT01596283|O2|Outcome|Goal Directed Fluid Therapy|"Prospective single-blinded randomized trial. Eligible patients will be consented for the trial prior to surgery. However randomization will not occur until the operating room. After the liver has been resected, intraoperative randomization will be done by envelopes.~Goal directed fluid therapy with the Edwards EV1000 system: This arm will have fluid therapy guided by the Edwards EV1000 system."
191477|NCT01596283|O1|Outcome|Standard Fluid Management|"Prospective single-blinded randomized trial. Eligible patients will be consented for the trial prior to surgery. However randomization will not occur until the operating room. After the liver has been resected, intraoperative randomization will be done by envelopes.~Standard fluid management: The patient will receive standard fluid management"
191500|NCT01596062|B4|Baseline|Total|Total of all reporting groups
194334|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
191478|NCT01596283|O2|Outcome|Goal Directed Fluid Therapy|"Prospective single-blinded randomized trial. Eligible patients will be consented for the trial prior to surgery. However randomization will not occur until the operating room. After the liver has been resected, intraoperative randomization will be done by envelopes.~Goal directed fluid therapy with the Edwards EV1000 system: This arm will have fluid therapy guided by the Edwards EV1000 system."
191479|NCT01596283|O1|Outcome|Standard Fluid Management|"Prospective single-blinded randomized trial. Eligible patients will be consented for the trial prior to surgery. However randomization will not occur until the operating room. After the liver has been resected, intraoperative randomization will be done by envelopes.~Standard fluid management: The patient will receive standard fluid management"
191480|NCT01596283|E2|Reported Event|Goal Directed Fluid Therapy|"Prospective single-blinded randomized trial. Eligible patients will be consented for the trial prior to surgery. However randomization will not occur until the operating room. After the liver has been resected, intraoperative randomization will be done by envelopes.~Goal directed fluid therapy with the Edwards EV1000 system: This arm will have fluid therapy guided by the Edwards EV1000 system."
191481|NCT01596283|E1|Reported Event|Standard Fluid Management|"Prospective single-blinded randomized trial. Eligible patients will be consented for the trial prior to surgery. However randomization will not occur until the operating room. After the liver has been resected, intraoperative randomization will be done by envelopes.~Standard fluid management: The patient will receive standard fluid management"
191482|NCT01596231|B3|Baseline|Total|Total of all reporting groups
191483|NCT01596231|B2|Baseline|Kudzu|"Kudzu 2mg~Kudzu: Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session to see if it will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session."
191484|NCT01596231|B1|Baseline|Placebo|"This is a study designed to test whether a single administration of kudzu extract (2 mg) or placebo will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session when given as a pretreatment 2 ½ hours before the drinking session.~Placebo: Placebo will be administered as a pretreatment 2 ½ hours before a drinking session"
191485|NCT01596231|P2|Participant Flow|Kudzu|"Kudzu 2mg~Kudzu: Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session to see if it will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session."
191486|NCT01596231|P1|Participant Flow|Placebo|"This is a study designed to test whether a single administration of kudzu extract (2 mg) or placebo will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session when given as a pretreatment 2 ½ hours before the drinking session.~Placebo: Placebo will be administered as a pretreatment 2 ½ hours before a drinking session"
191487|NCT01596231|O2|Outcome|Kudzu|Kudzu extract treatment significantly reduced the number of beers opened and total amounts (weight and volume) consumed. Latency and time to consume a beer was not significantly altered, and there was no difference in the number of sips taken to drink a beer.
191488|NCT01596231|O1|Outcome|Placebo|Placebo did not alter alcohol consumption compared to baseline.
191489|NCT01596231|E2|Reported Event|Kudzu|"Kudzu 2mg~Kudzu: Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session to see if it will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session."
191490|NCT01596231|E1|Reported Event|Placebo|"This is a study designed to test whether a single administration of kudzu extract (2 mg) or placebo will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session when given as a pretreatment 2 ½ hours before the drinking session.~Placebo: Placebo will be administered as a pretreatment 2 ½ hours before a drinking session"
191491|NCT01596127|B1|Baseline|Intrathecal Rituximab|"Phase I Starting Dose: Rituximab administered via lumbar puncture at dose of 10 - 25 mg twice weekly according to the dose escalation.~Phase II Rituximab Starting Dose: Maximum tolerated dose from Phase I.~Intrathecal Rituximab: Phase I: Starting dose Rituximab 10 mg intrathecally twice weekly until 2 consecutive CSF samples are negative for the presence of blast cells. Thereafter, rituximab 10 mg intrathecally weekly for additional 4 weeks, followed by intrathecal rituximab 10 mg administered once every other week for an additional 8 weeks.~Phase II Starting Dose of Rituximab: Maximum tolerated dose from Phase I."
191492|NCT01596127|P1|Participant Flow|Intrathecal Rituximab|"Phase I Starting Dose: Rituximab administered via lumbar puncture at dose of 10 - 25 mg twice weekly according to the dose escalation.~Phase II Rituximab Starting Dose: Maximum tolerated dose from Phase I.~Intrathecal Rituximab: Phase I: Starting dose Rituximab 10 mg intrathecally twice weekly until 2 consecutive CSF samples are negative for the presence of blast cells. Thereafter, rituximab 10 mg intrathecally weekly for additional 4 weeks, followed by intrathecal rituximab 10 mg administered once every other week for an additional 8 weeks.~Phase II Starting Dose of Rituximab: Maximum tolerated dose from Phase I."
191493|NCT01596127|O1|Outcome|Intrathecal Rituximab|"Phase I Starting Dose: Rituximab administered via lumbar puncture at dose of 10 - 25 mg twice weekly according to the dose escalation.~Phase II Rituximab Starting Dose: Maximum tolerated dose from Phase I.~Intrathecal Rituximab: Phase I: Starting dose Rituximab 10 mg intrathecally twice weekly until 2 consecutive CSF samples are negative for the presence of blast cells. Thereafter, rituximab 10 mg intrathecally weekly for additional 4 weeks, followed by intrathecal rituximab 10 mg administered once every other week for an additional 8 weeks.~Phase II Starting Dose of Rituximab: Maximum tolerated dose from Phase I."
191494|NCT01596127|O1|Outcome|Intrathecal Rituximab|"Phase I Starting Dose: Rituximab administered via lumbar puncture at dose of 10 - 25 mg twice weekly according to the dose escalation.~Phase II Rituximab Starting Dose: Maximum tolerated dose from Phase I.~Intrathecal Rituximab: Phase I: Starting dose Rituximab 10 mg intrathecally twice weekly until 2 consecutive CSF samples are negative for the presence of blast cells. Thereafter, rituximab 10 mg intrathecally weekly for additional 4 weeks, followed by intrathecal rituximab 10 mg administered once every other week for an additional 8 weeks.~Phase II Starting Dose of Rituximab: Maximum tolerated dose from Phase I."
191495|NCT01596127|E1|Reported Event|Intrathecal Rituximab|"Phase I Starting Dose: Rituximab administered via lumbar puncture at dose of 10 - 25 mg twice weekly according to the dose escalation.~Phase II Rituximab Starting Dose: Maximum tolerated dose from Phase I.~Intrathecal Rituximab: Phase I: Starting dose Rituximab 10 mg intrathecally twice weekly until 2 consecutive CSF samples are negative for the presence of blast cells. Thereafter, rituximab 10 mg intrathecally weekly for additional 4 weeks, followed by intrathecal rituximab 10 mg administered once every other week for an additional 8 weeks.~Phase II Starting Dose of Rituximab: Maximum tolerated dose from Phase I."
191502|NCT01596062|B2|Baseline|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
191503|NCT01596062|B1|Baseline|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
191504|NCT01596062|P3|Participant Flow|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
191505|NCT01596062|P2|Participant Flow|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
191506|NCT01596062|P1|Participant Flow|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
191507|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
191508|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
191509|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
191510|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
191511|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
191512|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
191513|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
191514|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
191515|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
191516|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
191517|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
191518|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
191519|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
191520|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
191521|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
191522|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
191523|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
191524|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
191525|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
191526|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
191527|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
191528|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
191529|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
191530|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
191531|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
191532|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
191533|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
191534|NCT01596062|E3|Reported Event|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
191535|NCT01596062|E2|Reported Event|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
191536|NCT01596062|E1|Reported Event|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
191537|NCT01595854|B6|Baseline|Total|Total of all reporting groups
191575|NCT01595646|O1|Outcome|Saline|"Saline placebo taken twice per day via intranasal route.~Saline: Saline, administered intranasally twice per day for a 16 week duration"
194335|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
191538|NCT01595854|B5|Baseline|Dabigatran Etexilate / Multiple Dose Ticagrelor - Part 3|"A randomised two-period cross-over trial, the two treatments administered were~A single dose of dabigatran etexilate 75 mg~Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered with a single dose of 75 mg Dabigatran etexilate on days 1 and 4.~Between treatment periods there was a washout period of at least 4 days."
191539|NCT01595854|B4|Baseline|Ticagrelor 180 mg - Part 2|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test
191540|NCT01595854|B3|Baseline|Dabigatran Etexilate 220 mg - Part 2|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test.
191541|NCT01595854|B2|Baseline|Ticagrelor 180 mg - Part 1|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test.
191542|NCT01595854|B1|Baseline|Dabigatran Etexilate 220 mg - Part 1|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test.
191543|NCT01595854|P5|Participant Flow|Dabigatran Etexilate/Multiple Dose Ticagrelor Crossover-Part 3|"A randomised, two-period, cross-over trial, the two treatments administered were~A single dose of dabigatran etexilate 75 mg~Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered is a single dose of 75 mg Dabigatran etexilate on days 1 and 4.~Between treatment periods there was a washout period of at least 4 days."
191544|NCT01595854|P4|Participant Flow|Ticagrelor 180 mg - Part 2|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test
191545|NCT01595854|P3|Participant Flow|Dabigatran Etexilate 220 mg - Part 2|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test.
191546|NCT01595854|P2|Participant Flow|Ticagrelor 180 mg - Part 1|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test.
191547|NCT01595854|P1|Participant Flow|Dabigatran Etexilate 220 mg - Part 1|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test.
191548|NCT01595854|O6|Outcome|Dabigatran + Ticagrelor - Part 3|Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered is a single dose of 75 mg Dabigatran etexilate on days 1 and 4.
191549|NCT01595854|O5|Outcome|Dabigatran 75 mg - Part 3|A single dose of Dabigatran etexilate 75 mg
191550|NCT01595854|O4|Outcome|Ticagrelor 180 mg - Part 2|A single dose of Ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test.
191551|NCT01595854|O3|Outcome|Dabigatran 220 mg - Part 2|A single dose of Dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test.
191552|NCT01595854|O2|Outcome|Ticagrelor 180 mg - Part 1|A single dose of Ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test.
191553|NCT01595854|O1|Outcome|Dabigatran 220 mg - Part 1|A single dose of Dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test.
191554|NCT01595854|O3|Outcome|Dabi + Ticagrelor MD|A single dose of 75 mg Dabigatran coadministered with a morning dose of multiple dose (LD) ticagrelor.
191555|NCT01595854|O2|Outcome|Dabi + Ticagrelor LD|A single dose of 75 mg Dabigatran coadministered with a loading dose (LD) of 180 mg ticagrelor coated tablets (T).
191556|NCT01595854|O1|Outcome|Dabi 75 mg|A single dose of Dabigatran etexilate (Dabi) 75 mg.
191557|NCT01595854|O3|Outcome|Dabi + Ticagrelor MD|A single dose of 75 mg Dabigatran coadministered with a morning dose of multiple dose (MD) ticagrelor.
191558|NCT01595854|O2|Outcome|Dabi + Ticagrelor LD|A single dose of 75 mg Dabigatran coadministered with a loading dose (LD) of 180 mg ticagrelor coated tablets (T).
191559|NCT01595854|O1|Outcome|Dabi 75 mg|A single dose of Dabigatran etexilate (Dabi) 75 mg.
191560|NCT01595854|E6|Reported Event|Multiple Dose Ticagrelor - Part 3|Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered is a single dose of 75 mg Dabigatran etexilate on days 1 and 4.
191561|NCT01595854|E5|Reported Event|Dabi 75 mg - Part 3|A single dose of dabigatran etexilate (Dabi) 75 mg
191562|NCT01595854|E4|Reported Event|Ticagrelor 180 mg - Part 2|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test
191563|NCT01595854|E3|Reported Event|Dabigatran Etexilate 220 mg - Part 2|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test.
191564|NCT01595854|E2|Reported Event|Ticagrelor 180 mg - Part 1|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test.
191565|NCT01595854|E1|Reported Event|Dabigatran Etexilate 220 mg - Part 1|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test.
191566|NCT01595646|B4|Baseline|Total|Total of all reporting groups
191567|NCT01595646|B3|Baseline|Insulin|"20IU Insulin, administered twice per day (40IU total per day)~Insulin: 20IU insulin, administered intranasally twice per day for a 16 week duration (total of 40IU insulin per day)"
191568|NCT01595646|B2|Baseline|Insulin Detemir|"20IU of Insulin Detemir taken twice per day (40IU total per day)~Insulin detemir: 20IU of insulin detemir, administered intranasally twice per day for a 16 week duration (total of 40IU insulin detemir per day)"
191569|NCT01595646|B1|Baseline|Saline|Saline: Saline, administered intranasally twice per day for a 16 week duration
191570|NCT01595646|P3|Participant Flow|Insulin|"20IU Insulin, administered twice per day (40IU total per day)~Insulin: 20IU insulin, administered intranasally twice per day for a 16 week duration (total of 40IU insulin per day)"
191571|NCT01595646|P2|Participant Flow|Insulin Detemir|"20IU of Insulin Detemir taken twice per day (40IU total per day)~Insulin detemir: 20IU of insulin detemir, administered intranasally twice per day for a 16 week duration (total of 40IU insulin detemir per day)"
191572|NCT01595646|P1|Participant Flow|Saline|Saline: Saline, administered intranasally twice per day for a 16 week duration
191573|NCT01595646|O3|Outcome|Insulin|"20IU Insulin, administered twice per day (40IU total per day) via intranasal route~Insulin: 20IU insulin, administered intranasally twice per day for a 16 week duration (total of 40IU insulin per day)"
191574|NCT01595646|O2|Outcome|Insulin Detemir|"20IU of Insulin Detemir taken twice per day (40IU total per day) via intranasal route~Insulin detemir: 20IU of insulin detemir, administered intranasally twice per day for a 16 week duration (total of 40IU insulin detemir per day)"
191636|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191576|NCT01595646|O3|Outcome|Insulin|"20IU Insulin, administered twice per day (40IU total per day) via intranasal route~Insulin: 20IU insulin, administered intranasally twice per day for a 16 week duration (total of 40IU insulin per day)"
191577|NCT01595646|O2|Outcome|Insulin Detemir|"20IU of Insulin Detemir taken twice per day (40IU total per day) via intranasal route~Insulin detemir: 20IU of insulin detemir, administered intranasally twice per day for a 16 week duration (total of 40IU insulin detemir per day)"
191578|NCT01595646|O1|Outcome|Saline|"Saline placebo taken twice per day via intranasal route.~Saline: Saline, administered intranasally twice per day for a 16 week duration"
191579|NCT01595646|O3|Outcome|Insulin|"20IU Insulin, administered twice per day (40IU total per day)~Insulin: 20IU insulin, administered intranasally twice per day for a 16 week duration (total of 40IU insulin per day)"
191580|NCT01595646|O2|Outcome|Insulin Detemir|"20IU of Insulin Detemir taken twice per day (40IU total per day)~Insulin detemir: 20IU of insulin detemir, administered intranasally twice per day for a 16 week duration (total of 40IU insulin detemir per day)"
191581|NCT01595646|O1|Outcome|Saline|Saline: Saline, administered intranasally twice per day for a 16 week duration
191582|NCT01595646|O3|Outcome|Insulin|"20IU Insulin, administered twice per day (40IU total per day)~Insulin: 20IU insulin, administered intranasally twice per day for a 16 week duration (total of 40IU insulin per day)"
191583|NCT01595646|O2|Outcome|Insulin Detemir|"20IU of Insulin Detemir taken twice per day (40IU total per day)~Insulin detemir: 20IU of insulin detemir, administered intranasally twice per day for a 16 week duration (total of 40IU insulin detemir per day)"
191584|NCT01595646|O1|Outcome|Saline|Saline: Saline, administered intranasally twice per day for a 16 week duration
191585|NCT01595646|O3|Outcome|Insulin|"20IU Insulin, administered twice per day (40IU total per day)~Insulin: 20IU insulin, administered intranasally twice per day for a 16 week duration (total of 40IU insulin per day)"
191586|NCT01595646|O2|Outcome|Insulin Detemir|"20IU of Insulin Detemir taken twice per day (40IU total per day)~Insulin detemir: 20IU of insulin detemir, administered intranasally twice per day for a 16 week duration (total of 40IU insulin detemir per day)"
191587|NCT01595646|O1|Outcome|Saline|Saline: Saline, administered intranasally twice per day for a 16 week duration
191588|NCT01595646|E3|Reported Event|Insulin|"20IU Insulin, administered twice per day (40IU total per day)~Insulin: 20IU insulin, administered intranasally twice per day for a 16 week duration (total of 40IU insulin per day)"
191589|NCT01595646|E2|Reported Event|Insulin Detemir|"20IU of Insulin Detemir taken twice per day (40IU total per day)~Insulin detemir: 20IU of insulin detemir, administered intranasally twice per day for a 16 week duration (total of 40IU insulin detemir per day)"
191590|NCT01595646|E1|Reported Event|Saline|Saline: Saline, administered intranasally twice per day for a 16 week duration
191591|NCT01595438|B3|Baseline|Total|Total of all reporting groups
191592|NCT01595438|B2|Baseline|Doripenem|Doripenem treatment group
191593|NCT01595438|B1|Baseline|CAZ-AVI|Ceftazidime-avibactam treatment group
191594|NCT01595438|P2|Participant Flow|Doripenem|Doripenem treatment group
191595|NCT01595438|P1|Participant Flow|CAZ-AVI|Ceftazidime-avibactam treatment group
191596|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191597|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191598|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191599|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191600|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191601|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191602|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191603|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191604|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191605|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191606|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191607|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191608|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191609|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191610|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191611|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191612|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191613|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191614|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191615|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191616|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191617|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191618|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191619|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191620|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191621|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191622|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191623|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191624|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191625|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191626|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191627|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191628|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191629|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191630|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191631|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191632|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191633|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191634|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191635|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191637|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191638|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191639|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191640|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191641|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191642|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191643|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191644|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191645|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191646|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191647|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191648|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191649|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191650|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191651|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191652|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191653|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191654|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191655|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191656|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191657|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191658|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191659|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191660|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191661|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191662|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191663|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191664|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191665|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191666|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191667|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191668|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191669|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191670|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191671|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191672|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191673|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191674|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191675|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191676|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191677|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191678|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191679|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191680|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191681|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191682|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191683|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191684|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191685|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191686|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191687|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191688|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191689|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191690|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191691|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191692|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191693|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191694|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191695|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191696|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191697|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191698|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191699|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191700|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191701|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191702|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191703|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191704|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191705|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191706|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191707|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191708|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191709|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191710|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191711|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191712|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191713|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191714|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
191715|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
191716|NCT01595438|E2|Reported Event|Doripenem|Doripenem treatment group
191717|NCT01595438|E1|Reported Event|CAZ-AVI|Ceftazidime-avibactam treatment group
191719|NCT01595386|B2|Baseline|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
191720|NCT01595386|B1|Baseline|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
191721|NCT01595386|P2|Participant Flow|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of cardiopulmonary bypass (CPB) and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
191722|NCT01595386|P1|Participant Flow|Normal Saline|"The subjects will receive a bolus after successful completion of bypass and the post-pump adrenocorticotrophic hormone (ACTH) stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
191723|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
191724|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
191725|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
191726|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
191727|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
191728|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
191729|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
191730|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
191731|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
191841|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
192689|NCT01591616|O10|Outcome|Vital Signs (Systolic), 70 Minutes Post-dose|
191732|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
191733|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
191734|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
191735|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
191736|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
191737|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
191738|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
191739|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
191740|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
191741|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
191742|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
191743|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
191744|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
191842|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191843|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
192690|NCT01591616|O9|Outcome|Vital Signs (Systolic), 60 Minutes Post-dose|
191745|NCT01595386|E2|Reported Event|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
191746|NCT01595386|E1|Reported Event|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
191747|NCT01595282|B3|Baseline|Total|Total of all reporting groups
191748|NCT01595282|B2|Baseline|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo~Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
191749|NCT01595282|B1|Baseline|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)~Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
191750|NCT01595282|P2|Participant Flow|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo~Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
191751|NCT01595282|P1|Participant Flow|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)~Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
191752|NCT01595282|O2|Outcome|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo~Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
191753|NCT01595282|O1|Outcome|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)~Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
191754|NCT01595282|O2|Outcome|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo~Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
191755|NCT01595282|O1|Outcome|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)~Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
191756|NCT01595282|O2|Outcome|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo~Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
191757|NCT01595282|O1|Outcome|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)~Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
191758|NCT01595282|E2|Reported Event|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo~Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
191844|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191949|NCT01594385|O2|Outcome|No Seprafilm|This group will be treated according to the current standard of care. No seprafilm will be applied in this subset of patients.
191759|NCT01595282|E1|Reported Event|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)~Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
191760|NCT01594970|B4|Baseline|Total|Total of all reporting groups
191761|NCT01594970|B3|Baseline|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
191762|NCT01594970|B2|Baseline|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
191763|NCT01594970|B1|Baseline|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
191764|NCT01594970|P3|Participant Flow|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
191765|NCT01594970|P2|Participant Flow|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
191766|NCT01594970|P1|Participant Flow|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
191767|NCT01594970|O3|Outcome|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
191768|NCT01594970|O2|Outcome|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
191769|NCT01594970|O1|Outcome|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
191770|NCT01594970|O3|Outcome|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
191771|NCT01594970|O2|Outcome|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
191772|NCT01594970|O1|Outcome|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
191773|NCT01594970|O3|Outcome|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
191774|NCT01594970|O2|Outcome|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
191775|NCT01594970|O1|Outcome|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
191776|NCT01594970|O3|Outcome|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
191777|NCT01594970|O2|Outcome|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
191778|NCT01594970|O1|Outcome|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
191779|NCT01594970|E3|Reported Event|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
191780|NCT01594970|E2|Reported Event|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
191781|NCT01594970|E1|Reported Event|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
191782|NCT01594762|B3|Baseline|Total|Total of all reporting groups
191783|NCT01594762|B2|Baseline|Topical Placebo Control|"Drug: Topical placebo cream~Topical placebo cream: 14 days of treatment~Standard wound care: 28-day trial period"
191784|NCT01594762|B1|Baseline|Topical Pexiganan Cream 0.8%|"Drug: Topical pexiganan cream 0.8%~Topical pexiganan cream 0.8%: 14 days of treatment~Standard wound care: 28-day trial period"
191785|NCT01594762|P2|Participant Flow|Topical Placebo Control|"Drug: Topical placebo cream~Topical placebo cream: 14 days of treatment + 14 days of follow-up (28-day trial period)~Standard wound care: 28-day trial period"
191786|NCT01594762|P1|Participant Flow|Topical Pexiganan Cream 0.8%|"Drug: Topical pexiganan cream 0.8%~Topical pexiganan cream 0.8%: 14 days of treatment + 14 days of follow-up (28-day trial period)~Standard wound care: 28-day trial period"
191787|NCT01594762|O2|Outcome|Topical Placebo Control|"Drug: Topical placebo cream~Topical placebo cream: 14 days of treatment"
191788|NCT01594762|O1|Outcome|Topical Pexiganan Cream 0.8%|"Drug: Topical pexiganan cream 0.8%~Topical pexiganan cream 0.8%: 14 days of treatment"
191789|NCT01594762|O2|Outcome|Topical Placebo Control|"Drug: Topical placebo cream~Topical placebo cream: 14 days of treatment"
191790|NCT01594762|O1|Outcome|Topical Pexiganan Cream 0.8%|"Drug: Topical pexiganan cream 0.8%~Topical pexiganan cream 0.8%: 14 days of treatment"
191791|NCT01594762|O2|Outcome|Topical Placebo Control|"Drug: Topical placebo cream~Topical placebo cream: 14 days of treatment"
191792|NCT01594762|O1|Outcome|Topical Pexiganan Cream 0.8%|"Drug: Topical pexiganan cream 0.8%~Topical pexiganan cream 0.8%: 14 days of treatment"
191793|NCT01594762|E2|Reported Event|Topical Placebo Control|"Drug: Topical placebo cream~Topical placebo cream: 14 days of treatment"
191794|NCT01594762|E1|Reported Event|Topical Pexiganan Cream 0.8%|"Drug: Topical pexiganan cream 0.8%~Topical pexiganan cream 0.8%: 14 days of treatment"
191795|NCT01594749|B3|Baseline|Total|Total of all reporting groups
191950|NCT01594385|O1|Outcome|Seprafilm|The treatment group will receive Seprafilm.
191796|NCT01594749|B2|Baseline|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
191797|NCT01594749|B1|Baseline|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
191798|NCT01594749|P2|Participant Flow|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
191799|NCT01594749|P1|Participant Flow|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg intravenous (IV) infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, orally (PO) ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-hydroxytryptamine 3 (5-HT3) antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
191800|NCT01594749|O2|Outcome|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
191801|NCT01594749|O1|Outcome|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
191802|NCT01594749|O2|Outcome|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
191803|NCT01594749|O1|Outcome|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
191845|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191846|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
194336|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
191804|NCT01594749|O2|Outcome|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
191805|NCT01594749|O1|Outcome|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
191806|NCT01594749|O2|Outcome|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
191807|NCT01594749|O1|Outcome|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
191808|NCT01594749|O2|Outcome|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
191809|NCT01594749|O1|Outcome|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
191810|NCT01594749|O2|Outcome|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
191811|NCT01594749|O1|Outcome|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
191847|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191848|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
192065|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
191812|NCT01594749|E2|Reported Event|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
191813|NCT01594749|E1|Reported Event|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
191814|NCT01594515|B11|Baseline|Total|Total of all reporting groups
191815|NCT01594515|B10|Baseline|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
191816|NCT01594515|B9|Baseline|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191817|NCT01594515|B8|Baseline|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191818|NCT01594515|B7|Baseline|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191819|NCT01594515|B6|Baseline|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191820|NCT01594515|B5|Baseline|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191821|NCT01594515|B4|Baseline|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191822|NCT01594515|B3|Baseline|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191823|NCT01594515|B2|Baseline|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191824|NCT01594515|B1|Baseline|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191825|NCT01594515|P10|Participant Flow|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
191826|NCT01594515|P9|Participant Flow|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191827|NCT01594515|P8|Participant Flow|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191828|NCT01594515|P7|Participant Flow|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191829|NCT01594515|P6|Participant Flow|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191830|NCT01594515|P5|Participant Flow|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191831|NCT01594515|P4|Participant Flow|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191832|NCT01594515|P3|Participant Flow|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191833|NCT01594515|P2|Participant Flow|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191834|NCT01594515|P1|Participant Flow|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191835|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191836|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191837|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191838|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191839|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191840|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
192691|NCT01591616|O8|Outcome|Vital Signs (Systolic), 50 Minutes Post-dose|
191849|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191850|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191851|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191852|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191853|NCT01594515|O10|Outcome|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
191854|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191855|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191856|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191857|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191858|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191859|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191860|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191861|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191862|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191863|NCT01594515|O10|Outcome|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
191864|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191865|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191866|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191867|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191868|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191869|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191870|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191871|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191872|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191873|NCT01594515|O10|Outcome|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
191874|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191875|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191876|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191877|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191878|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191879|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191880|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191881|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191882|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191883|NCT01594515|O10|Outcome|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
191947|NCT01594385|O2|Outcome|No Seprafilm|This group will be treated according to the current standard of care. No seprafilm will be applied in this subset of patients.
191884|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191885|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191886|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191887|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191888|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191889|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191890|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191891|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191892|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191893|NCT01594515|O10|Outcome|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
191894|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191895|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191896|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191897|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191898|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191899|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191900|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191901|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191902|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191903|NCT01594515|O10|Outcome|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
191904|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191905|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191906|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191907|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191908|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191909|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191910|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191911|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191912|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191913|NCT01594515|E10|Reported Event|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191914|NCT01594515|E9|Reported Event|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191915|NCT01594515|E8|Reported Event|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191916|NCT01594515|E7|Reported Event|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191917|NCT01594515|E6|Reported Event|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191918|NCT01594515|E5|Reported Event|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191948|NCT01594385|O1|Outcome|Seprafilm|The treatment group will receive Seprafilm.
191919|NCT01594515|E4|Reported Event|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191920|NCT01594515|E3|Reported Event|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191921|NCT01594515|E2|Reported Event|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
191922|NCT01594515|E1|Reported Event|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
191923|NCT01594424|B1|Baseline|IVIG + Tocilizumab (TCZ)|All patients received IVIg 10% (2.0 g/kg [maximum 140 g per dose] on days 1 and 30) and TCZ (8 mg/kg administered on day 15, then monthly for 6 months). If transplanted, patients received IVIg on day 0; TCZ on day 2 and TCZ monthly for 6 months patients received alemtuzumab 30 mg subcutaneously x1 dose as induction and were maintained on triple regimen with tacrolimus (target level of 7 to 9 ng/mL in first 6 months; then 5-7 ng/mL between 6 and 12 months; then 3-5 ng/mL thereafter); mycophenolate mofetil and prednisone taper.
191924|NCT01594424|P1|Participant Flow|IVIG + Tocilizumab (TCZ)|All patients received IVIg 10% (2.0 g/kg [maximum 140 g per dose] on days 1 and 30) and TCZ (8 mg/kg administered on day 15, then monthly for 6 months). If transplanted, patients received IVIg on day 0; TCZ on day 2 and TCZ monthly for 6 months patients received alemtuzumab 30 mg subcutaneously x1 dose as induction and were maintained on triple regimen with tacrolimus (target level of 7 to 9 ng/mL in first 6 months; then 5-7 ng/mL between 6 and 12 months; then 3-5 ng/mL thereafter); mycophenolate mofetil and prednisone taper.
191925|NCT01594424|O1|Outcome|IVIG + Tocilizumab (TCZ)|All patients received IVIg 10% (2.0 g/kg [maximum 140 g per dose] on days 1 and 30) and TCZ (8 mg/kg administered on day 15, then monthly for 6 months). If transplanted, patients received IVIg on day 0; TCZ on day 2 and TCZ monthly for 6 months patients received alemtuzumab 30 mg subcutaneously x1 dose as induction and were maintained on triple regimen with tacrolimus (target level of 7 to 9 ng/mL in first 6 months; then 5-7 ng/mL between 6 and 12 months; then 3-5 ng/mL thereafter); mycophenolate mofetil and prednisone taper.
191926|NCT01594424|E1|Reported Event|IVIG + Tocilizumab|All patients received IVIg 10% (2.0 g/kg [maximum 140 g per dose] on days 1 and 30) and TCZ (8 mg/kg administered on day 15, then monthly for 6 months). If transplanted, patients received IVIg on day 0; TCZ on day 2 and TCZ monthly for 6 months patients received alemtuzumab 30 mg subcutaneously x1 dose as induction and were maintained on triple regimen with tacrolimus (target level of 7 to 9 ng/mL in first 6 months; then 5-7 ng/mL between 6 and 12 months; then 3-5 ng/mL thereafter); mycophenolate mofetil and prednisone taper.
191927|NCT01594411|B1|Baseline|All Subjects|Subjects are enrolled at multiple participating primary care practices. The main inclusion criterion for enrollment is the occurrence of chest pain (or anginal equivalent) in a patient without known significant CAD or a history of prior myocardial infarction.
191928|NCT01594411|P1|Participant Flow|All Subjects With Corus CAD|Subjects are enrolled at multiple participating primary care practices. The main inclusion criterion for enrollment and being tested with Corus CAD is the occurrence of chest pain (or anginal equivalent) in a patient without known significant CAD or a history of prior myocardial infarction.
191929|NCT01594411|O4|Outcome|Invasive Angiography|Physician decision for invasive coronary angiography after receiving patients' GES
191930|NCT01594411|O3|Outcome|Stress Test|Physician decision for stress testing (with or without imaging) or computed tomography/coronary angiography after receiving patients' GES
191931|NCT01594411|O2|Outcome|Medical Therapy|Physician decision for lifestyle changes or medical therapy after receiving patients' GES
191932|NCT01594411|O1|Outcome|No Tests/Treatment|Physician decision for no additional tests or cardiac treatment after receiving patients' GES
191933|NCT01594411|E1|Reported Event|All Subjects|Subjects are enrolled at multiple participating primary care practices. The main inclusion criterion for enrollment is the occurrence of chest pain (or anginal equivalent) in a patient without known significant CAD or a history of prior myocardial infarction.
191934|NCT01594385|B3|Baseline|Total|Total of all reporting groups
191935|NCT01594385|B2|Baseline|No Seprafilm|Patients in this group will not receive Seprafilm during re-operations. Otherwise, their surgical management will be identical to the Seprafilm Group.
191936|NCT01594385|B1|Baseline|Seprafilm|"The treatment group will receive Seprafilm while the control group will not receive Seprafilm. Allocation of patients will be in approximately 1:1 ratio.~Seprafilm: Two sheets of the Seprafilm material will be applied at each reoperation. Each sheet will be cut into 1x1 inch squares and applied to the following anatomic areas:~Two Seprafilm pieces between the liver and the anterior abdominal wall~Four pieces over the exposed bowel surfaces anteriorly~Two slightly staggered pieces of Seprafilm in each colic gutter~Two pieces in the pelvic area.~If any of the above areas involve an anastomosis or bowel repair, then the Seprafilm should be placed at least 1 inch away from the anastomosis and/or bowel repair."
191937|NCT01594385|P2|Participant Flow|No Seprafilm Group|Patients randomized to this group received no Seprafilm; Abdominal washout at the beginning of each procedure was performed in a fashion identical that in the Seprafilm Group.
191938|NCT01594385|P1|Participant Flow|Seprafilm Group|Patient who randomized to this group received seprafilm at the end of each consecutive operation; Seprafilm from each previous operation was washed out at the beginning of each subsequent re-operation.
191939|NCT01594385|O2|Outcome|No Seprafilm|This group will be treated according to the current standard of care. No seprafilm will be applied in this subset of patients.
191940|NCT01594385|O1|Outcome|Seprafilm|The treatment group will receive Seprafilm.
191941|NCT01594385|O2|Outcome|No Seprafilm|This group will be treated according to the current standard of care. No seprafilm will be applied in this subset of patients.
191942|NCT01594385|O1|Outcome|Seprafilm|The treatment group will receive Seprafilm.
191943|NCT01594385|O2|Outcome|No Seprafilm|This group will be treated according to the current standard of care. No seprafilm will be applied in this subset of patients.
191944|NCT01594385|O1|Outcome|Seprafilm|The treatment group will receive Seprafilm.
191945|NCT01594385|O2|Outcome|No Seprafilm|This group will be treated according to the current standard of care. No seprafilm will be applied in this subset of patients.
191946|NCT01594385|O1|Outcome|Seprafilm|The treatment group will receive Seprafilm.
191951|NCT01594385|O2|Outcome|No Seprafilm|This group will be treated according to the current standard of care. No seprafilm will be applied in this subset of patients.
191952|NCT01594385|O1|Outcome|Seprafilm|The treatment group will receive Seprafilm.
191953|NCT01594385|O2|Outcome|Wound Sizes: No Seprafilm|"Wound size characteristics (estimated area = Width x Length in centimeters squared) for patients who did not receive Seprafilm"
191954|NCT01594385|O1|Outcome|Wound Sizes: Seprafilm|"Wound size characteristics (estimated area = Width x Length in centimeters squared) for patients who received Seprafilm"
191955|NCT01594385|O2|Outcome|No Seprafilm|Operation Number Zuhlke scores (mean / standard error) Operation #1 1.08 / 0.28 Operation #2 1.08 / 0.28 Operation #3 1.19 / 0.32 Operation #4 1.63 / 0.58 Operation #5 2.33 / 0.82 Operation #6 2.92 / 0.83 Operation #7 2.84 / 0.23
191956|NCT01594385|O1|Outcome|Seprafilm|Operation Number Zuhlke scores (mean / standard error) Operation #1 1.06 / 0.24 Operation #2 1.13 / 0.34 Operation #3 1.54 / 0.69 Operation #4 1.39 / 0.49 Operation #5 1.21 / 0.39 Operation #6 1.50 / 0.77 Operation #7 1.38 / 0.25
191957|NCT01594385|E2|Reported Event|No Seprafilm Group|Patients randomized to this group received no Seprafilm; Abdominal washout at the beginning of each procedure was performed in a fashion identical that in the Seprafilm Group.
191958|NCT01594385|E1|Reported Event|Seprafilm Group|Patient who randomized to this group received seprafilm at the end of each consecutive operation; Seprafilm from each previous operation was washed out at the beginning of each subsequent re-operation.
191959|NCT01594294|B3|Baseline|Total|Total of all reporting groups
191960|NCT01594294|B2|Baseline|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
191961|NCT01594294|B1|Baseline|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
191962|NCT01594294|P2|Participant Flow|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
191963|NCT01594294|P1|Participant Flow|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
191964|NCT01594294|O2|Outcome|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
191965|NCT01594294|O1|Outcome|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
191966|NCT01594294|O2|Outcome|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
191967|NCT01594294|O1|Outcome|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
191968|NCT01594294|O2|Outcome|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
191969|NCT01594294|O1|Outcome|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
191970|NCT01594294|O2|Outcome|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
191971|NCT01594294|O1|Outcome|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
191972|NCT01594294|O2|Outcome|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
191973|NCT01594294|O1|Outcome|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
191974|NCT01594294|E2|Reported Event|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
191975|NCT01594294|E1|Reported Event|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
191976|NCT01594125|B6|Baseline|Total|Total of all reporting groups
191977|NCT01594125|B5|Baseline|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
191978|NCT01594125|B4|Baseline|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
191979|NCT01594125|B3|Baseline|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
191980|NCT01594125|B2|Baseline|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
191981|NCT01594125|B1|Baseline|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
191982|NCT01594125|P5|Participant Flow|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
191983|NCT01594125|P4|Participant Flow|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
192692|NCT01591616|O7|Outcome|Vital Signs (Systolic), 40 Minutes Post-dose|
191984|NCT01594125|P3|Participant Flow|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
191985|NCT01594125|P2|Participant Flow|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
191986|NCT01594125|P1|Participant Flow|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
191987|NCT01594125|O5|Outcome|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
191988|NCT01594125|O4|Outcome|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
191989|NCT01594125|O3|Outcome|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
191990|NCT01594125|O2|Outcome|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
191991|NCT01594125|O1|Outcome|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
191992|NCT01594125|O5|Outcome|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
191993|NCT01594125|O4|Outcome|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
191994|NCT01594125|O3|Outcome|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
191995|NCT01594125|O2|Outcome|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
191996|NCT01594125|O1|Outcome|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
191997|NCT01594125|O5|Outcome|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
191998|NCT01594125|O4|Outcome|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
191999|NCT01594125|O3|Outcome|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
192000|NCT01594125|O2|Outcome|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
192001|NCT01594125|O1|Outcome|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
192002|NCT01594125|O5|Outcome|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
192003|NCT01594125|O4|Outcome|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
192004|NCT01594125|O3|Outcome|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
192005|NCT01594125|O2|Outcome|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
192006|NCT01594125|O1|Outcome|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
192007|NCT01594125|O5|Outcome|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
192363|NCT01592240|O5|Outcome|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
192008|NCT01594125|O4|Outcome|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
192009|NCT01594125|O3|Outcome|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
192010|NCT01594125|O2|Outcome|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
192011|NCT01594125|O1|Outcome|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
192012|NCT01594125|E5|Reported Event|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
192013|NCT01594125|E4|Reported Event|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
192014|NCT01594125|E3|Reported Event|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
192015|NCT01594125|E2|Reported Event|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
192016|NCT01594125|E1|Reported Event|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
192017|NCT01593852|B3|Baseline|Total|Total of all reporting groups
192018|NCT01593852|B2|Baseline|Regular X-ray Dose Settings|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
192019|NCT01593852|B1|Baseline|Reduced X-ray Dose Settings|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
192020|NCT01593852|P2|Participant Flow|Regular X-ray Dose Settings|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
192021|NCT01593852|P1|Participant Flow|Reduced X-ray Dose Settings|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
192022|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
192023|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
192024|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
192025|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
192026|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
192027|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
192028|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
192029|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
192030|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
192031|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
192032|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
192033|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
192034|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
192221|NCT01592708|B2|Baseline|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
192035|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
192036|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
192037|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
192038|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
192039|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
192040|NCT01593852|E2|Reported Event|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
192041|NCT01593852|E1|Reported Event|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
192042|NCT01593787|B4|Baseline|Total|Total of all reporting groups
192043|NCT01593787|B3|Baseline|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
192044|NCT01593787|B2|Baseline|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
192045|NCT01593787|B1|Baseline|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
192046|NCT01593787|P3|Participant Flow|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
192047|NCT01593787|P2|Participant Flow|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
192048|NCT01593787|P1|Participant Flow|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
192049|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
192050|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
192051|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
192052|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
192053|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
192054|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
192055|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
192056|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
192057|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
192058|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
192059|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
192060|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
192061|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
192062|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
192063|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
192064|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
192066|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
192067|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
192068|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
192069|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
192070|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
192071|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
192072|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
192073|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
192074|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
192075|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
192076|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
192077|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
192078|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
192079|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
192080|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
192081|NCT01593787|E4|Reported Event|LCZ 200 mg|LCZ 200 mg
192082|NCT01593787|E3|Reported Event|Total LCZ696|All participants who received LCZ696
192083|NCT01593787|E2|Reported Event|LCZ 400 mg|LCZ 400 mg
192084|NCT01593787|E1|Reported Event|LCZ 100 mg|LCZ 100 mg
192085|NCT01593722|B3|Baseline|Total|Total of all reporting groups
192086|NCT01593722|B2|Baseline|SIngle Dose IVM|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
192087|NCT01593722|B1|Baseline|Single Dose DEC|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
192088|NCT01593722|P2|Participant Flow|Single Dose IVM|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
192089|NCT01593722|P1|Participant Flow|Single Dose DEC|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
192090|NCT01593722|O2|Outcome|Ivermectin|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
192091|NCT01593722|O1|Outcome|Diethylcarbamazine|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
192092|NCT01593722|O2|Outcome|Ivermectin|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
192093|NCT01593722|O1|Outcome|Diethylcarbamazine|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
192094|NCT01593722|O2|Outcome|Single Dose IVM|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
192095|NCT01593722|O1|Outcome|Single Dose DEC|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
192096|NCT01593722|O2|Outcome|Ivermectin|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
192097|NCT01593722|O1|Outcome|Diethylcarbamazine|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
192098|NCT01593722|O2|Outcome|Ivermectin|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
192099|NCT01593722|O1|Outcome|Diethylcarbamazine|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
192100|NCT01593722|E2|Reported Event|Ivermectin|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
192101|NCT01593722|E1|Reported Event|Diethylcarbamazine|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
192102|NCT01593670|B1|Baseline|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.~Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.~Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15~Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17~Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
192116|NCT01593592|O1|Outcome|Control Group|"The control group that will receive the standard triple therapy and placebo~Placebo : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks."
192222|NCT01592708|B1|Baseline|Intervention Cohort|This arm was managed perioperatively with the protocol.
192103|NCT01593670|P1|Participant Flow|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.~Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.~Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15~Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17~Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
192104|NCT01593670|O1|Outcome|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.~Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.~Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15~Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17~Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
192105|NCT01593670|O1|Outcome|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.~Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.~Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15~Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17~Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
192106|NCT01593670|O1|Outcome|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.~Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.~Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15~Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17~Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
192107|NCT01593670|O1|Outcome|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.~Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.~Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15~Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17~Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
192108|NCT01593670|O1|Outcome|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.~Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.~Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15~Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17~Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
192109|NCT01593670|E1|Reported Event|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.~Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.~Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15~Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17~Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
192110|NCT01593592|B3|Baseline|Total|Total of all reporting groups
192111|NCT01593592|B2|Baseline|Control Group|The control group that will receive the standard triple therapy and placebo
192112|NCT01593592|B1|Baseline|Lactobacillus Reuteri Group|The active group that will receive the standard triple therapy and Lactobacillus reuteri
192113|NCT01593592|P2|Participant Flow|Lactobacillus Reuteri Group|"The active group that will receive the standard triple therapy and Lactobacillus reuteri~Lactobacillus reuteri : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks."
192114|NCT01593592|P1|Participant Flow|Control Group|"The control group that will receive the standard triple therapy and placebo~Placebo : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks."
192115|NCT01593592|O2|Outcome|Lactobacillus Reuteri Group|"The active group that will receive the standard triple therapy and Lactobacillus reuteri~Lactobacillus reuteri : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks."
192693|NCT01591616|O6|Outcome|Vital Signs (Systolic), 30 Minutes Post-dose|
192117|NCT01593592|O2|Outcome|Lactobacillus Reuteri Group|"The active group that will receive the standard triple therapy and Lactobacillus reuteri~Lactobacillus reuteri : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks."
192118|NCT01593592|O1|Outcome|Control Group|"The control group that will receive the standard triple therapy and placebo~Placebo : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks."
192119|NCT01593592|O2|Outcome|Lactobacillus Reuteri Group|"The active group that will receive the standard triple therapy and Lactobacillus reuteri~Lactobacillus reuteri : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks."
192120|NCT01593592|O1|Outcome|Control Group|"The control group that will receive the standard triple therapy and placebo~Placebo : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks."
192121|NCT01593592|E2|Reported Event|Control Group|"The control group that will receive the standard triple therapy and placebo~Placebo: Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks."
192122|NCT01593592|E1|Reported Event|Lactobacillus Reuteri Group|"The active group that will receive the standard triple therapy and Lactobacillus reuteri~Lactobacillus reuteri: Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks."
192123|NCT01593215|B3|Baseline|Total|Total of all reporting groups
192124|NCT01593215|B2|Baseline|Yohimbine First Then Yohimbine|Yohimbine first and then placebo
192125|NCT01593215|B1|Baseline|Placebo First Then Yohimbine|"placebo first~Yohimbine: Yohimbine capsule"
192126|NCT01593215|P2|Participant Flow|Yohimbine First Then Placebo|Yohimbine first, 2 weeks washout and then placebo
192127|NCT01593215|P1|Participant Flow|Placebo First Then Yohimbine|Placebo first, then 2 weeks washout and then yohimbine
192128|NCT01593215|O2|Outcome|Yohimbine|"Yohimbine~Yohimbine: Yohimbine capsule"
192129|NCT01593215|O1|Outcome|Placebo|"placebo~Yohimbine: Yohimbine capsule"
192130|NCT01593215|E2|Reported Event|Yohimbine|"Yohimbine~Yohimbine: Yohimbine capsule"
192131|NCT01593215|E1|Reported Event|Placebo|"placebo~Yohimbine: Yohimbine capsule"
192132|NCT01592864|B3|Baseline|Total|Total of all reporting groups
192133|NCT01592864|B2|Baseline|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
192134|NCT01592864|B1|Baseline|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
192135|NCT01592864|P2|Participant Flow|Sodium Monofluorophosphate (NaMFP) Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
192136|NCT01592864|P1|Participant Flow|Stannous Fluoride (SnF) Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 milliliter (mL) of water.
192137|NCT01592864|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
192138|NCT01592864|O1|Outcome|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
192139|NCT01592864|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
192140|NCT01592864|O1|Outcome|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
192141|NCT01592864|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
192142|NCT01592864|O1|Outcome|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
192143|NCT01592864|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
192144|NCT01592864|O1|Outcome|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
192145|NCT01592864|E2|Reported Event|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
192146|NCT01592864|E1|Reported Event|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
192147|NCT01592851|B3|Baseline|Total|Total of all reporting groups
192148|NCT01592851|B2|Baseline|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
192149|NCT01592851|B1|Baseline|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
192150|NCT01592851|P2|Participant Flow|Sodium Monofluorophosphate (NaMFP) Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% Sodium Monofluorophosphate [NaMFP]) for one timed minute, followed by rinsing with 5 mL of water.
192151|NCT01592851|P1|Participant Flow|Stannous Fluoride (SnF) Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
192152|NCT01592851|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
192153|NCT01592851|O1|Outcome|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
192154|NCT01592851|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
192155|NCT01592851|O1|Outcome|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
192156|NCT01592851|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
192157|NCT01592851|O1|Outcome|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
192158|NCT01592851|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
192159|NCT01592851|O1|Outcome|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
192160|NCT01592851|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
192161|NCT01592851|O1|Outcome|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
192162|NCT01592851|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
192163|NCT01592851|O1|Outcome|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
192164|NCT01592851|E2|Reported Event|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
192165|NCT01592851|E1|Reported Event|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
192166|NCT01592786|B1|Baseline|Memantine Hydrochloride (HCl)|Memantine Hydrochloride (HCl) extended-release 3-mg capsules once daily, oral administration. Dosing was 3-mg, 6-mg, 9-mg, 12-mg, or 15-mg per day, based upon patient weight.
192167|NCT01592786|P1|Participant Flow|Memantine Hydrochloride (HCl)|Memantine Hydrochloride (HCl) extended-release 3-mg capsules once daily oral administration. Dosing was 3-mg, 6-mg, 9-mg, 12-mg, or 15-mg per day, based upon patient weight.
192168|NCT01592786|O1|Outcome|Memantine Hydrochloride (HCl)|Memantine Hydrochloride (HCl) extended-release 3-mg capsules once daily, oral administration. Dosing was 3-mg, 6-mg, 9-mg, 12-mg or 15-mg per day, based upon patient weight.
192169|NCT01592786|E1|Reported Event|Memantine Hydrochloride (HCl)|Memantine Hydrochloride (HCl) extended-release 3-mg capsules, oral administration. Dosing was 3-mg, 6-mg, 9-mg, 12-mg or 15-mg, once per day, based upon patient weight.
192170|NCT01592773|B1|Baseline|Memantine|"To maintain the blind of the preceding study, patients who participated in MEM-MD-68 began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.~Patients who took open-label memantine in the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage."
192171|NCT01592773|P1|Participant Flow|Memantine|"To maintain the blind of the preceding study, patients who participated in MEM-MD-68 began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.~Patients who took open-label memantine in the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage."
192172|NCT01592773|O1|Outcome|Memantine|"To maintain the blind of the preceding study, patients who participated in MEM-MD-68 began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.~Patients who took open-label memantine in the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage."
192364|NCT01592240|O4|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192173|NCT01592773|E1|Reported Event|Memantine|"To maintain the blind of the preceding study, patients who participated in MEM-MD-68 began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.~Patients who took open-label memantine in the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage."
192174|NCT01592760|B4|Baseline|Total|Total of all reporting groups
192175|NCT01592760|B3|Baseline|I-gel|"i-gel, sizes 3, 4, and 5 (Intersurgical Inc., Liverpool, NY, USA)~i-gel: i-gel placement for airway maintenance."
192176|NCT01592760|B2|Baseline|Air-Q SP|"air-Q Self-Pressurizing Intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mercury Medical, Clearwater, FL, USA)~air-Q SP: air-Q SP placement for airway maintenance."
192177|NCT01592760|B1|Baseline|Air-Q|"air-Q Intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mercury Medical, Clearwater, FL, USA)~air-Q SP: air-Q SP placement for airway maintenance."
192178|NCT01592760|P3|Participant Flow|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
192179|NCT01592760|P2|Participant Flow|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
192180|NCT01592760|P1|Participant Flow|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
192181|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
192182|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
192183|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
192184|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
192185|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
192186|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
192187|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
192188|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
192189|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
192190|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
192191|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
192192|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
192193|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
192194|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
192195|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
192196|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
192197|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
192198|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
192199|NCT01592760|O3|Outcome|I-gel|"i-gel, sizes 3, 4, and 5 (Intersurgical Inc., Liverpool, NY, USA)~i-gel: i-gel placement for airway maintenance."
192200|NCT01592760|O2|Outcome|Air-Q|"air-Q Intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mercury Medical, Clearwater, FL, USA)~air-Q: air-Q placement for airway maintenance."
192201|NCT01592760|O1|Outcome|Air-Q SP|"air-Q Self-Pressurizing Intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mercury Medical, Clearwater, FL, USA)~air-Q SP: air-Q SP placement for airway maintenance."
192202|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
192203|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
192204|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
192205|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
192206|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
192207|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
192208|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
192209|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
192210|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
192211|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
192212|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
192213|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
192214|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
192215|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
192216|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
192217|NCT01592760|E3|Reported Event|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
192218|NCT01592760|E2|Reported Event|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
192219|NCT01592760|E1|Reported Event|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
192220|NCT01592708|B3|Baseline|Total|Total of all reporting groups
192223|NCT01592708|P2|Participant Flow|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
192224|NCT01592708|P1|Participant Flow|Intervention Cohort|Patients undergoing maxillary surgery using antiemetic anesthesia protocol
192225|NCT01592708|O2|Outcome|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation, who completed the post-discharge diary
192226|NCT01592708|O1|Outcome|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthetic protocol who completed the post-discharge diary
192227|NCT01592708|O2|Outcome|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
192228|NCT01592708|O1|Outcome|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthetic protocol
192229|NCT01592708|O2|Outcome|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation, who completed the post-discharge diary
192230|NCT01592708|O1|Outcome|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthetic protocol who completed the post-discharge diary.
192231|NCT01592708|O2|Outcome|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
192232|NCT01592708|O1|Outcome|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthetic protocol
192233|NCT01592708|O2|Outcome|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
192234|NCT01592708|O1|Outcome|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthetic protocol
192235|NCT01592708|E2|Reported Event|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
192236|NCT01592708|E1|Reported Event|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthesia protocol
192237|NCT01592695|B3|Baseline|Total|Total of all reporting groups
192238|NCT01592695|B2|Baseline|Enhanced Standard of Care Group|"Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.~Tobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."
192239|NCT01592695|B1|Baseline|Tailored Intervention Group|"Participants will receive a combined behavioral and pharmacological intervention.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination."
192240|NCT01592695|P2|Participant Flow|Enhanced Standard of Care Group|"Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.~Tobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."
192241|NCT01592695|P1|Participant Flow|Tailored Intervention Group|"Participants will receive a combined behavioral and pharmacological intervention.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.~Tailored behavioral intervention: Participants will receive a standard six session cognitive behavioral intervention for smoking cessation combined with supplemental treatment modules treatment modules to address common issues associated with cigarette smoking based on individual need and preference. Individual treatment models address alcohol risk reduction, elevated depressive symptoms, and concerns about weight gain."
192242|NCT01592695|O1|Outcome|Tailored Intervention Group|"Participants will receive a combined behavioral and pharmacological intervention.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination."
192243|NCT01592695|O1|Outcome|Tailored Intervention Group|"Participants will receive a combined behavioral and pharmacological intervention.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination."
192244|NCT01592695|O2|Outcome|Enhanced Standard of Care Group|"Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.~Tobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."
192245|NCT01592695|O1|Outcome|Tailored Intervention Group|"Participants will receive a combined behavioral and pharmacological intervention.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination."
192246|NCT01592695|O2|Outcome|Enhanced Standard of Care Group|"Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.~Tobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."
192247|NCT01592695|O1|Outcome|Tailored Intervention Group|"Participants will receive a combined behavioral and pharmacological intervention.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination."
192248|NCT01592695|O2|Outcome|Enhanced Standard of Care Group|"Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.~Tobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."
192249|NCT01592695|O1|Outcome|Tailored Intervention Group|"Participants will receive a combined behavioral and pharmacological intervention.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination."
192250|NCT01592695|O2|Outcome|Enhanced Standard of Care Group|"Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.~Tobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."
192251|NCT01592695|O1|Outcome|Tailored Intervention Group|"Participants will receive a combined behavioral and pharmacological intervention.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination."
192252|NCT01592695|O2|Outcome|Enhanced Standard of Care Group|"Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.~Tobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."
192253|NCT01592695|O1|Outcome|Tailored Intervention Group|"Participants will receive a combined behavioral and pharmacological intervention.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination."
192254|NCT01592695|O2|Outcome|Enhanced Standard of Care Group|"Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.~Tobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."
192255|NCT01592695|O1|Outcome|Tailored Intervention Group|"Participants will receive a combined behavioral and pharmacological intervention.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination."
192298|NCT01592292|B2|Baseline|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
192299|NCT01592292|B1|Baseline|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
192256|NCT01592695|E2|Reported Event|Enhanced Standard of Care Group|"Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.~Tobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."
192257|NCT01592695|E1|Reported Event|Tailored Intervention Group|"Participants will receive a combined behavioral and pharmacological intervention.~Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination."
192258|NCT01592435|B1|Baseline|Pred. & Invest.-All Study Participants|"Cedera AccuStitch Software is standard of care software currently used at sites.~Carestream DR LLI software is investigational software used for reconstruction"
192259|NCT01592435|P1|Participant Flow|Pred. & Invest.-All Study Participants|"Cedera AccuStitch Software is standard of care software currently used at sites.~Carestream DR LLI software is investigational software used for reconstruction."
192260|NCT01592435|O1|Outcome|Invest. - Carestream DR LLI Software|Carestream DR LLI software is investigational software used for reconstruction.
192261|NCT01592435|O1|Outcome|Predicate - Cedera AccuStitch Software|Cedera AccuStitch Software is standard of care software currently used at sites.
192262|NCT01592435|E2|Reported Event|Invest. - Carestream DR LLI Software|Carestream DR LLI software is investigational software used for reconstruction.
192263|NCT01592435|E1|Reported Event|Predicate - Cedera AccuStitch Software|Cedara Accustitch is the standard of care software currently used by sites.
192264|NCT01592396|B3|Baseline|Total|Total of all reporting groups
192265|NCT01592396|B2|Baseline|Tralokinumab 300 mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
192266|NCT01592396|B1|Baseline|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
192267|NCT01592396|P2|Participant Flow|Tralokinumab 300 mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
192268|NCT01592396|P1|Participant Flow|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
192269|NCT01592396|O1|Outcome|Tralokinumab 300mg|Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
192270|NCT01592396|O1|Outcome|Tralokinumab 300 mg|Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
192271|NCT01592396|O2|Outcome|Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
192272|NCT01592396|O1|Outcome|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
192273|NCT01592396|O2|Outcome|Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
192274|NCT01592396|O1|Outcome|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
192275|NCT01592396|O2|Outcome|Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
192276|NCT01592396|O1|Outcome|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
192277|NCT01592396|O2|Outcome|Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
192278|NCT01592396|O1|Outcome|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
192279|NCT01592396|O2|Outcome|Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
192280|NCT01592396|O1|Outcome|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
192281|NCT01592396|E1|Reported Event|Tralokinumab 300 mg|Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
192282|NCT01592344|B3|Baseline|Total|Total of all reporting groups
192283|NCT01592344|B2|Baseline|Control|Subjects implanted with the StimRouter lead and randomized to receive no electrical stimulation.
192284|NCT01592344|B1|Baseline|Active Stimulation Treatment|Subjects implanted with the StimRouter lead and randomized to receive active stimulation.
192285|NCT01592344|P2|Participant Flow|Control|Subjects implanted with the StimRouter lead and randomized to receive no electrical stimulation.
192286|NCT01592344|P1|Participant Flow|Active Stimulation Treatment|Subjects implanted with the StimRouter lead and randomized to receive active stimulation.
192300|NCT01592292|P4|Participant Flow|Other Anti-TNF Agent: Infliximab|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving infliximab as per physician’s discretion for RA treatment were observed for 12 months.
192365|NCT01592240|O3|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192287|NCT01592344|O2|Outcome|StimRouter - Control|"StimRouter- Electrical stimulation is withheld from the targeted peripheral nerve after fully implanting the StimRouter lead. The rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes is placed for transdermal stimulation but no stimulation is delivered. The EPT which normally receives radio frequency (RF) commands from a Patient Programmer is not activated. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer such that no stimulation occurs in the Control Arm of the study.~StimRouter - Control: The stimulation program settings for this arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 200 µsec~Pulse Rate: 1 Hz~Intensity: 0 mA Time Settings~Constant Stim: On~Total Time: 6 hour"
192288|NCT01592344|O1|Outcome|StimRouter - Active Stimulation|"StimRouter- active electrical stimulation is applied transdermally to a targeted peripheral nerve. This is accomplished via a fully implanted StimRouter lead that receives energy from a rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes. The EPT receives radio frequency (RF) commands from a Patient Programmer. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer. Up to eight stimulation programs may be saved on a Patient Programmer for on-demand selection by the study patient.~StimRouter - active stimulation: The stimulation program settings for this arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 100-250 µsec~Pulse Rate: 50-100 Hz~Intensity: 0-30mA Time Settings~Constant Stim: On~Total Time: 6 hour"
192289|NCT01592344|O2|Outcome|StimRouter - Control|"StimRouter- Electrical stimulation is withheld from the targeted peripheral nerve after fully implanting the StimRouter lead. The rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes is placed for transdermal stimulation but no stimulation is delivered. The EPT which normally receives radio frequency (RF) commands from a Patient Programmer is not activated. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer such that no stimulation occurs in the Control Arm of the study.~StimRouter - Control: The stimulation program settings for this arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 200 µsec~Pulse Rate: 1 Hz~Intensity: 0 mA Time Settings~Constant Stim: On~Total Time: 6 hour"
192290|NCT01592344|O1|Outcome|StimRouter - Active Stimulation|"StimRouter- active electrical stimulation is applied transdermally to a targeted peripheral nerve. This is accomplished via a fully implanted StimRouter lead that receives energy from a rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes. The EPT receives radio frequency (RF) commands from a Patient Programmer. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer. Up to eight stimulation programs may be saved on a Patient Programmer for on-demand selection by the study patient.~StimRouter - active stimulation: The stimulation program settings for this arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 100-250 µsec~Pulse Rate: 50-100 Hz~Intensity: 0-30mA Time Settings~Constant Stim: On~Total Time: 6 hour"
192291|NCT01592344|O2|Outcome|StimRouter - Control|"StimRouter- Electrical stimulation is withheld from the targeted peripheral nerve after fully implanting the StimRouter lead. The rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes is placed for transdermal stimulation but no stimulation is delivered. The EPT which normally receives radio frequency (RF) commands from a Patient Programmer is not activated. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer such that no stimulation occurs in the Control Arm of the study.~StimRouter - Control: The stimulation program settings for this arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 200 µsec~Pulse Rate: 1 Hz~Intensity: 0 mA Time Settings~Constant Stim: On~Total Time: 6 hour"
192292|NCT01592344|O1|Outcome|StimRouter - Active Stimulation|"StimRouter- active electrical stimulation is applied transdermally to a targeted peripheral nerve. This is accomplished via a fully implanted StimRouter lead that receives energy from a rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes. The EPT receives radio frequency (RF) commands from a Patient Programmer. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer. Up to eight stimulation programs may be saved on a Patient Programmer for on-demand selection by the study patient.~StimRouter - active stimulation: The stimulation program settings for this arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 100-250 µsec~Pulse Rate: 50-100 Hz~Intensity: 0-30mA Time Settings~Constant Stim: On~Total Time: 6 hour"
192293|NCT01592344|O2|Outcome|StimRouter - Control|"StimRouter- Electrical stimulation is withheld from the targeted peripheral nerve after fully implanting the StimRouter lead. The rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes is placed for transdermal stimulation but no stimulation is delivered. The EPT which normally receives radio frequency (RF) commands from a Patient Programmer is not activated. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer such that no stimulation occurs in the Control Arm of the study.~StimRouter - Control: The stimulation program settings for this arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 200 µsec~Pulse Rate: 1 Hz~Intensity: 0 mA Time Settings~Constant Stim: On~Total Time: 6 hour"
192294|NCT01592344|O1|Outcome|StimRouter - Active Stimulation|"StimRouter- active electrical stimulation is applied transdermally to a targeted peripheral nerve. This is accomplished via a fully implanted StimRouter lead that receives energy from a rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes. The EPT receives radio frequency (RF) commands from a Patient Programmer. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer. Up to eight stimulation programs may be saved on a Patient Programmer for on-demand selection by the study patient.~StimRouter - active stimulation: The stimulation program settings for this arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 100-250 µsec~Pulse Rate: 50-100 Hz~Intensity: 0-30mA Time Settings~Constant Stim: On~Total Time: 6 hour"
192295|NCT01592344|E2|Reported Event|StimRouter Control|"The stimulation program settings for the control arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 200 µsec~Pulse Rate: 1 Hz~Intensity: 0 mA Time Settings~Constant Stim: On~Total Time: 6 hour"
192296|NCT01592344|E1|Reported Event|StimRouter Active Stimulation|"The stimulation program settings for the active stimulation arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 100-250 µsec~Pulse Rate: 50-100 Hz~Intensity: 0-30mA Time Settings~Constant Stim: On~Total Time: 6 hour"
192297|NCT01592292|B3|Baseline|Total|Total of all reporting groups
192362|NCT01592240|O6|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192301|NCT01592292|P3|Participant Flow|Other Anti-TNF Agent: Etanercept|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving etanercept as per physician’s discretion for RA treatment were observed for 12 months.
192302|NCT01592292|P2|Participant Flow|Other Anti-TNF Agent: Adalimumab|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving adalimumab as per physician’s discretion for RA treatment were observed for 12 months.
192303|NCT01592292|P1|Participant Flow|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
192304|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
192305|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
192306|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
192307|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
192308|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
192309|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
192310|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
192311|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
192312|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
192313|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
192314|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
192315|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
192316|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
192317|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
192318|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
192319|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
192320|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
192321|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
192322|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
192323|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
192324|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
192325|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
194337|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
192326|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
192327|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
192328|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
192329|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
192330|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
192331|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
192332|NCT01592292|E2|Reported Event|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
192333|NCT01592292|E1|Reported Event|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
192334|NCT01592240|B8|Baseline|Total|Total of all reporting groups
192335|NCT01592240|B7|Baseline|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192336|NCT01592240|B6|Baseline|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192337|NCT01592240|B5|Baseline|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
192338|NCT01592240|B4|Baseline|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192339|NCT01592240|B3|Baseline|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192340|NCT01592240|B2|Baseline|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192341|NCT01592240|B1|Baseline|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
192342|NCT01592240|P7|Participant Flow|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192343|NCT01592240|P6|Participant Flow|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192344|NCT01592240|P5|Participant Flow|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
192345|NCT01592240|P4|Participant Flow|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192346|NCT01592240|P3|Participant Flow|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192347|NCT01592240|P2|Participant Flow|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192348|NCT01592240|P1|Participant Flow|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
192349|NCT01592240|O7|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192350|NCT01592240|O6|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192351|NCT01592240|O5|Outcome|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
192352|NCT01592240|O4|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192353|NCT01592240|O3|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192354|NCT01592240|O2|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192355|NCT01592240|O1|Outcome|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
192356|NCT01592240|O5|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192357|NCT01592240|O4|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192358|NCT01592240|O3|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192359|NCT01592240|O2|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192360|NCT01592240|O1|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192361|NCT01592240|O7|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192366|NCT01592240|O2|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192367|NCT01592240|O1|Outcome|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
192368|NCT01592240|O5|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192369|NCT01592240|O4|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192370|NCT01592240|O3|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192371|NCT01592240|O2|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192372|NCT01592240|O1|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192373|NCT01592240|O7|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192374|NCT01592240|O6|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192375|NCT01592240|O5|Outcome|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
192376|NCT01592240|O4|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192377|NCT01592240|O3|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192378|NCT01592240|O2|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192379|NCT01592240|O1|Outcome|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
192380|NCT01592240|O7|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192381|NCT01592240|O6|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192382|NCT01592240|O5|Outcome|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
192383|NCT01592240|O4|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192384|NCT01592240|O3|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192385|NCT01592240|O2|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192386|NCT01592240|O1|Outcome|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
192387|NCT01592240|O7|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192388|NCT01592240|O6|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192389|NCT01592240|O5|Outcome|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
192390|NCT01592240|O4|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192391|NCT01592240|O3|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192392|NCT01592240|O2|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192393|NCT01592240|O1|Outcome|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
192394|NCT01592240|O7|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192395|NCT01592240|O6|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192396|NCT01592240|O5|Outcome|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
192397|NCT01592240|O4|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192398|NCT01592240|O3|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192399|NCT01592240|O2|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192400|NCT01592240|O1|Outcome|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
192401|NCT01592240|O7|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192402|NCT01592240|O6|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192403|NCT01592240|O5|Outcome|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
192404|NCT01592240|O4|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192405|NCT01592240|O3|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192694|NCT01591616|O5|Outcome|Vital Signs (Systolic), 20 Minutes Post-dose|
192406|NCT01592240|O2|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192407|NCT01592240|O1|Outcome|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
192408|NCT01592240|O7|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192409|NCT01592240|O6|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192410|NCT01592240|O5|Outcome|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
192411|NCT01592240|O4|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192412|NCT01592240|O3|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192413|NCT01592240|O2|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192414|NCT01592240|O1|Outcome|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
192415|NCT01592240|O7|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192416|NCT01592240|O6|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192417|NCT01592240|O5|Outcome|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
192418|NCT01592240|O4|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192419|NCT01592240|O3|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192420|NCT01592240|O2|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192421|NCT01592240|O1|Outcome|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
192422|NCT01592240|O7|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192423|NCT01592240|O6|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192424|NCT01592240|O5|Outcome|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
192425|NCT01592240|O4|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192426|NCT01592240|O3|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192427|NCT01592240|O2|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192428|NCT01592240|O1|Outcome|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
192429|NCT01592240|O7|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192430|NCT01592240|O6|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192431|NCT01592240|O5|Outcome|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
192432|NCT01592240|O4|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192433|NCT01592240|O3|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192434|NCT01592240|O2|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192435|NCT01592240|O1|Outcome|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
192436|NCT01592240|O7|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192437|NCT01592240|O6|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192438|NCT01592240|O5|Outcome|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
192439|NCT01592240|O4|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192440|NCT01592240|O3|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192441|NCT01592240|O2|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192442|NCT01592240|O1|Outcome|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
192443|NCT01592240|O7|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192444|NCT01592240|O6|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192445|NCT01592240|O5|Outcome|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
192695|NCT01591616|O4|Outcome|Vital Signs (Systolic), 10 Minutes Post-dose|
192446|NCT01592240|O4|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192447|NCT01592240|O3|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192448|NCT01592240|O2|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192449|NCT01592240|O1|Outcome|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
192450|NCT01592240|O7|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192451|NCT01592240|O6|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192452|NCT01592240|O5|Outcome|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
192453|NCT01592240|O4|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192454|NCT01592240|O3|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192455|NCT01592240|O2|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192456|NCT01592240|O1|Outcome|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
192457|NCT01592240|O7|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192458|NCT01592240|O6|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192459|NCT01592240|O5|Outcome|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
192460|NCT01592240|O4|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192461|NCT01592240|O3|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192462|NCT01592240|O2|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192463|NCT01592240|O1|Outcome|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
192464|NCT01592240|O7|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192465|NCT01592240|O6|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192466|NCT01592240|O5|Outcome|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
192467|NCT01592240|O4|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192468|NCT01592240|O3|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192469|NCT01592240|O2|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192470|NCT01592240|O1|Outcome|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
192471|NCT01592240|O7|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192472|NCT01592240|O6|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192473|NCT01592240|O5|Outcome|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
192474|NCT01592240|O4|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192475|NCT01592240|O3|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192476|NCT01592240|O2|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192477|NCT01592240|O1|Outcome|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
192478|NCT01592240|O7|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192479|NCT01592240|O6|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192480|NCT01592240|O5|Outcome|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
192481|NCT01592240|O4|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192482|NCT01592240|O3|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192483|NCT01592240|O2|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192484|NCT01592240|O1|Outcome|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
192485|NCT01592240|O7|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192696|NCT01591616|O3|Outcome|Vital Signs (Systolic), 0 Minutes Pre-dose|
192486|NCT01592240|O6|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192487|NCT01592240|O5|Outcome|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
192488|NCT01592240|O4|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192489|NCT01592240|O3|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192490|NCT01592240|O2|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192491|NCT01592240|O1|Outcome|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
192492|NCT01592240|O7|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192493|NCT01592240|O6|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192494|NCT01592240|O5|Outcome|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
192495|NCT01592240|O4|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192496|NCT01592240|O3|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192497|NCT01592240|O2|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192498|NCT01592240|O1|Outcome|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
192499|NCT01592240|O7|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192500|NCT01592240|O6|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192501|NCT01592240|O5|Outcome|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
192502|NCT01592240|O4|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192503|NCT01592240|O3|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192504|NCT01592240|O2|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192505|NCT01592240|O1|Outcome|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
192506|NCT01592240|O7|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192507|NCT01592240|O6|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192508|NCT01592240|O5|Outcome|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
192509|NCT01592240|O4|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192510|NCT01592240|O3|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192511|NCT01592240|O2|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192512|NCT01592240|O1|Outcome|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
192513|NCT01592240|O7|Outcome|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192514|NCT01592240|O6|Outcome|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192515|NCT01592240|O5|Outcome|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
192516|NCT01592240|O4|Outcome|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192517|NCT01592240|O3|Outcome|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192518|NCT01592240|O2|Outcome|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
192519|NCT01592240|O1|Outcome|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
192520|NCT01592240|E7|Reported Event|PF-04950615 300 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
192521|NCT01592240|E6|Reported Event|PF-04950615 200 mg: Every 28 Days|Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
192522|NCT01592240|E5|Reported Event|Placebo: Every 28 Days|Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
192523|NCT01592240|E4|Reported Event|PF-04950615 150 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
192524|NCT01592240|E3|Reported Event|PF-04950615 100 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
192525|NCT01592240|E2|Reported Event|PF-04950615 50 mg: Every 14 Days|Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
194338|NCT01587079|O8|Outcome|GP MDI 18 μg (PT001)|18 μg
192526|NCT01592240|E1|Reported Event|Placebo: Every 14 Days|Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
192527|NCT01592071|B1|Baseline|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
192528|NCT01592071|P1|Participant Flow|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
192529|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
192530|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
192531|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
192532|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
192533|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
192534|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
192535|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
192536|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
192537|NCT01592071|E1|Reported Event|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
192538|NCT01592045|B3|Baseline|Total|Total of all reporting groups
192539|NCT01592045|B2|Baseline|Sequence 2|"NCI ch14.18 for two courses followed by UTC ch14.18 for three courses~ch14.18 -NCI: 25 mg/m^2/day IV for four consecutive days~ch14.18-UTC: 17.5 mg/m^2/day IV for four consecutive days~Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF): GM-CSF will be administered SC at a dose of 250 mcg/m^2/day for 14 days during Courses 1, 3, and 5.~Aldesleukin (IL-2): Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m^2/day for the first week and at a dose of 4.5 MIU/m^2/day for the second week during Courses 2 and 4.~Isotretinoin: Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:~If weight > 12 kg: 80 mg/m^2/dose twice daily (total daily dose is 160 mg/m^2/day, divided twice daily).~If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily)."
192540|NCT01592045|B1|Baseline|Sequence 1|"UTC ch14.18 for two courses followed by NCI ch14.18 for three courses~ch14.18 -NCI: 25 mg/m^2/day IV for four consecutive days~ch14.18-UTC: 17.5 mg/m^2/day IV for four consecutive days~Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF): GM-CSF will be administered SC at a dose of 250 mcg/m^2/day for 14 days during Courses 1, 3, and 5.~Aldesleukin (IL-2): Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m^2/day for the first week and at a dose of 4.5 MIU/m^2/day for the second week during Courses 2 and 4.~Isotretinoin: Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:~If weight > 12 kg: 80 mg/m^2/dose twice daily (total daily dose is 160 mg/m^2/day, divided twice daily).~If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily)."
192566|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
192567|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
192697|NCT01591616|O2|Outcome|Vital Signs (Systolic), - 10 Minutes Pre-dose|
192698|NCT01591616|O1|Outcome|Vital Signs (Systolic), - 20 Minutes Pre-dose|
192541|NCT01592045|P2|Participant Flow|Sequence 2|"NCI ch14.18 for two courses followed by UTC ch14.18 for three courses~ch14.18 -NCI: 25 mg/m^2/day IV for four consecutive days~ch14.18-UTC: 17.5 mg/m^2/day IV for four consecutive days~Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF): GM-CSF will be administered SC at a dose of 250 mcg/m^2/day for 14 days during Courses 1, 3, and 5.~Aldesleukin (IL-2): Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m^2/day for the first week and at a dose of 4.5 MIU/m^2/day for the second week during Courses 2 and 4.~Isotretinoin: Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:~If weight > 12 kg: 80 mg/m^2/dose twice daily (total daily dose is 160 mg/m^2/day, divided twice daily).~If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily)."
192542|NCT01592045|P1|Participant Flow|Sequence 1|"UTC ch14.18 for two courses followed by NCI ch14.18 for three courses~ch14.18 -NCI: 25 mg/m^2/day IV for four consecutive days~ch14.18-UTC: 17.5 mg/m^2/day IV for four consecutive days~Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF): GM-CSF will be administered SC at a dose of 250 mcg/m^2/day for 14 days during Courses 1, 3, and 5.~Aldesleukin (IL-2): Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m^2/day for the first week and at a dose of 4.5 MIU/m^2/day for the second week during Courses 2 and 4.~Isotretinoin: Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:~If weight > 12 kg: 80 mg/m^2/dose twice daily (total daily dose is 160 mg/m^2/day, divided twice daily).~If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily)."
192543|NCT01592045|O2|Outcome|NCI ch14.18|NCI Manufactured ch14.18
192544|NCT01592045|O1|Outcome|UTC ch14.18|United Therapeutics Manufactured ch14.18
192545|NCT01592045|O2|Outcome|NCI ch14.18|NCI Manufactured ch14.18
192546|NCT01592045|O1|Outcome|UTC ch14.18|United Therapeutics Manufactured ch14.18
192547|NCT01592045|E2|Reported Event|NCI ch14.18|NCI Manufactured ch14.18
192548|NCT01592045|E1|Reported Event|UTC ch14.18|United Therapeutics Manufactured ch14.18
192549|NCT01592006|B1|Baseline|HCV, LT, Pegasys, Ribavirin, Telaprevir|Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
192550|NCT01592006|P1|Participant Flow|HCV, LT, Pegasys, Ribavirin, Telaprevir|Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
192551|NCT01592006|O1|Outcome|HCV, LT, Pegasys, Ribavirin, Telaprevir|Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
192552|NCT01592006|O1|Outcome|HCV, LT, Pegasys, Ribavirin, Telaprevir|Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
192553|NCT01592006|E1|Reported Event|HCV, LT, Pegasys, Ribavirin, Telaprevir|Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
192554|NCT01591954|B1|Baseline|Video Augmentation|"Qualitative assessment of the value of video-based navigation system~Video Augmentation: Assessment of value of video-based navigation system"
192555|NCT01591954|P1|Participant Flow|Video Augmentation|"Qualitative assessment of the value of video-based navigation system~Video Augmentation: Assessment of value of video-based navigation system"
192556|NCT01591954|O1|Outcome|Video Augmentation|"Qualitative assessment of the value of video-based navigation system~Video Augmentation: Assessment of value of video-based navigation system"
192557|NCT01591954|O1|Outcome|Video Augmentation|"Qualitative assessment of the value of video-based navigation system~Video Augmentation: Assessment of value of video-based navigation system"
192558|NCT01591954|E1|Reported Event|Video Augmentation|"Qualitative assessment of the value of video-based navigation system~Video Augmentation: Assessment of value of video-based navigation system"
192559|NCT01591863|B1|Baseline|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
192560|NCT01591863|P1|Participant Flow|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
192561|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
192562|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
192563|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
192564|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
192565|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
192687|NCT01591616|O12|Outcome|Vital Signs (Systolic), 90 Minutes Post-dose|
192568|NCT01591863|E1|Reported Event|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
192569|NCT01591837|B3|Baseline|Total|Total of all reporting groups
192570|NCT01591837|B2|Baseline|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
192571|NCT01591837|B1|Baseline|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
192572|NCT01591837|P2|Participant Flow|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
192573|NCT01591837|P1|Participant Flow|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
192574|NCT01591837|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
192575|NCT01591837|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
192576|NCT01591837|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
192577|NCT01591837|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
192578|NCT01591837|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
192579|NCT01591837|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
192580|NCT01591837|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
192581|NCT01591837|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
192582|NCT01591837|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
192583|NCT01591837|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
192584|NCT01591837|E2|Reported Event|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
192585|NCT01591837|E1|Reported Event|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
192586|NCT01591733|B1|Baseline|FOLFIRINOX + Radiation|"All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.~FOLFIRINOX: Up to Eight-14 day cycles~Capecitabine: Orally, for 10 days~Short Course Radiation: Five or ten days~Surgery: 1-4 weeks after completion of capecitabine therapy"
192587|NCT01591733|P1|Participant Flow|FOLFIRINOX + Radiation|"All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.~FOLFIRINOX: Up to Eight-14 day cycles~Capecitabine: Orally, for 10 days~Short Course Radiation: Five or ten days~Surgery: 1-4 weeks after completion of capecitabine therapy"
192588|NCT01591733|O1|Outcome|FOLFIRINOX + Radiation|"All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.~FOLFIRINOX: Up to Eight-14 day cycles~Capecitabine: Orally, for 10 days~Short Course Radiation: Five or ten days~Surgery: 1-4 weeks after completion of capecitabine therapy"
192589|NCT01591733|O1|Outcome|FOLFIRINOX + Radiation|"All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.~FOLFIRINOX: Up to Eight-14 day cycles~Capecitabine: Orally, for 10 days~Short Course Radiation: Five or ten days~Surgery: 1-4 weeks after completion of capecitabine therapy"
192590|NCT01591733|O1|Outcome|FOLFIRINOX + Radiation|"All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.~FOLFIRINOX: Up to Eight-14 day cycles~Capecitabine: Orally, for 10 days~Short Course Radiation: Five or ten days~Surgery: 1-4 weeks after completion of capecitabine therapy"
192591|NCT01591733|O1|Outcome|FOLFIRINOX + Radiation|"All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.~FOLFIRINOX: Up to Eight-14 day cycles~Capecitabine: Orally, for 10 days~Short Course Radiation: Five or ten days~Surgery: 1-4 weeks after completion of capecitabine therapy"
192592|NCT01591733|O1|Outcome|FOLFIRINOX + Radiation|"All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.~FOLFIRINOX: Up to Eight-14 day cycles~Capecitabine: Orally, for 10 days~Short Course Radiation: Five or ten days~Surgery: 1-4 weeks after completion of capecitabine therapy"
192593|NCT01591733|O1|Outcome|FOLFIRINOX + Radiation|"All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.~FOLFIRINOX: Up to Eight-14 day cycles~Capecitabine: Orally, for 10 days~Short Course Radiation: Five or ten days~Surgery: 1-4 weeks after completion of capecitabine therapy"
192594|NCT01591733|O2|Outcome|Resected Participants - FOLFIRINOX + Radiation|"The participants that were resected.~All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.~FOLFIRINOX: Up to Eight-14 day cycles~Capecitabine: Orally, for 10 days~Short Course Radiation: Five or ten days~Surgery: 1-4 weeks after completion of capecitabine therapy"
192595|NCT01591733|O1|Outcome|All Eligible - FOLFIRINOX + Radiation|"The overall study population~All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.~FOLFIRINOX: Up to Eight-14 day cycles~Capecitabine: Orally, for 10 days~Short Course Radiation: Five or ten days~Surgery: 1-4 weeks after completion of capecitabine therapy"
192596|NCT01591733|E1|Reported Event|FOLFIRINOX + Radiation|"All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.~FOLFIRINOX: Up to Eight-14 day cycles~Capecitabine: Orally, for 10 days~Short Course Radiation: Five or ten days~Surgery: 1-4 weeks after completion of capecitabine therapy"
194339|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
192597|NCT01591681|B1|Baseline|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
192598|NCT01591681|P1|Participant Flow|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
192599|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
192600|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
192601|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
192602|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
192603|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
192604|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
192605|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
192606|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
192607|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
192608|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
192609|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
192610|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
192611|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
192612|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
192613|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
192614|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
192615|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
192616|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
192617|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
192618|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
192619|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
192688|NCT01591616|O11|Outcome|Vital Signs (Systolic) 80 Minutes Post-dose|
192620|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
192621|NCT01591681|E2|Reported Event|Standard of Care|On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
192622|NCT01591681|E1|Reported Event|Pump Suspension Algorithm|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.)
192623|NCT01591616|B1|Baseline|Oraqix for Tooth Extraction|lidocaine and prilocaine: Appropriate dose of Oraqix based on weight will be given before tooth extraction
192624|NCT01591616|P1|Participant Flow|Oraqix for Tooth Extraction|lidocaine and prilocaine: Appropriate dose of Oraqix based on weight will be given before tooth extraction
192625|NCT01591616|O4|Outcome|QTcB Interval, 4 Hour Post-dose|
192626|NCT01591616|O3|Outcome|QTcB Interval, 2 Hour Post-dose|
192627|NCT01591616|O2|Outcome|QTcB Interval, 1 Hour Post-dose|
192628|NCT01591616|O1|Outcome|QTcB Interval, Pre-dose|
192629|NCT01591616|O4|Outcome|QT Interval, 4 Hour Post-dose|
192630|NCT01591616|O3|Outcome|QT Interval, 2 Hour Post-dose|
192631|NCT01591616|O2|Outcome|QT Interval, 1 Hour Post-dose|
192632|NCT01591616|O1|Outcome|QT Interval, Pre-dose|
192633|NCT01591616|O4|Outcome|QRS Duration, 4 Hour Post-dose|
192634|NCT01591616|O3|Outcome|QRS Duration, 2 Hour Post-dose|
192635|NCT01591616|O2|Outcome|QRS Duration, 1 Hour Post-dose|
192636|NCT01591616|O1|Outcome|QRS Duration, Pre-dose|
192637|NCT01591616|O4|Outcome|PR Interval, 4 Hour Post-dose|
192638|NCT01591616|O3|Outcome|PR Interval, 2 Hour Post-dose|
192639|NCT01591616|O2|Outcome|PR Interval, 1 Hour Post-dose|
192640|NCT01591616|O1|Outcome|PR Interval, Pre-dose|
192641|NCT01591616|O4|Outcome|Ventricular Heart Rate, 4 Hour Post-dose|
192642|NCT01591616|O3|Outcome|Ventricular Heart Rate, 2 Hour Post-dose|
192643|NCT01591616|O2|Outcome|Ventricular Heart Rate, 1 Hour Post-dose|
192644|NCT01591616|O1|Outcome|Ventricular Heart Rate, Pre-dose|
192645|NCT01591616|O27|Outcome|Vital Signs (Diastolic), 240 Minutes Post-dose|
192646|NCT01591616|O26|Outcome|Vital Signs (Diastolic), 230 Minutes Post-dose|
192647|NCT01591616|O25|Outcome|Vital Signs (Diastolic), 220 Minutes Post-dose|
192648|NCT01591616|O24|Outcome|Vital Signs (Diastolic), 210 Minutes Post-dose|
192649|NCT01591616|O23|Outcome|Vital Signs (Diastolic), 200 Minutes Post-dose|
192650|NCT01591616|O22|Outcome|Vital Signs (Diastolic), 190 Minutes Post-dose|
192651|NCT01591616|O21|Outcome|Vital Signs (Diastolic), 180 Minutes Post-dose|
192652|NCT01591616|O20|Outcome|Vital Signs (Diastolic), 170 Minutes Post-dose|
192653|NCT01591616|O19|Outcome|Vital Signs (Diastolic), 160 Minutes Post-dose|
192654|NCT01591616|O18|Outcome|Vital Signs (Diastolic), 150 Minutes Post-dose|
192655|NCT01591616|O17|Outcome|Vital Signs (Diastolic), 140 Minutes Post-dose|
192656|NCT01591616|O16|Outcome|Vital Signs Diastolic(), 130 Minutes Post-dose|
192657|NCT01591616|O15|Outcome|Vital Signs (Diastolic), 120 Minutes Post-dose|
192658|NCT01591616|O14|Outcome|Vital Signs (Diastolic), 110 Minutes Post-dose|
192659|NCT01591616|O13|Outcome|Vital Signs (Diastolic), 100 Minutes Post-dose|
192660|NCT01591616|O12|Outcome|Vital Signs (Diastolic), 90 Minutes Post-dose|
192661|NCT01591616|O11|Outcome|Vital Signs (Diastolic) 80 Minutes Post-dose|
192662|NCT01591616|O10|Outcome|Vital Signs (Diastolic), 70 Minutes Post-dose|
192663|NCT01591616|O9|Outcome|Vital Signs Diastolic(), 60 Minutes Post-dose|
192664|NCT01591616|O8|Outcome|Vital Signs (Diastolic), 50 Minutes Post-dose|
192665|NCT01591616|O7|Outcome|Vital Signs (Diastolic), 40 Minutes Post-dose|
192666|NCT01591616|O6|Outcome|Vital Signs (Diastolic), 30 Minutes Post-dose|
192667|NCT01591616|O5|Outcome|Vital Signs (Diastolic), 20 Minutes Post-dose|
192668|NCT01591616|O4|Outcome|Vital Signs (Diastolic), 10 Minutes Post-dose|
192669|NCT01591616|O3|Outcome|Vital Signs (Diastolic), 0 Minutes Pre-dose|
192670|NCT01591616|O2|Outcome|Vital Signs (Diastolic), - 10 Minutes Pre-dose|
192671|NCT01591616|O1|Outcome|Vital Signs (Diastolic), - 20 Minutes Pre-dose|
192672|NCT01591616|O27|Outcome|Vital Signs (Systolic), 240 Minutes Post-dose|
192673|NCT01591616|O26|Outcome|Vital Signs (Systolic), 230 Minutes Post-dose|
192674|NCT01591616|O25|Outcome|Vital Signs (Systolic), 220 Minutes Post-dose|
192675|NCT01591616|O24|Outcome|Vital Signs (Systolic), 210 Minutes Post-dose|
192676|NCT01591616|O23|Outcome|Vital Signs (Systolic), 200 Minutes Post-dose|
192677|NCT01591616|O22|Outcome|Vital Signs (Systolic), 190 Minutes Post-dose|
192678|NCT01591616|O21|Outcome|Vital Signs (Systolic), 180 Minutes Post-dose|
192679|NCT01591616|O20|Outcome|Vital Signs (Systolic), 170 Minutes Post-dose|
192680|NCT01591616|O19|Outcome|Vital Signs (Systolic), 160 Minutes Post-dose|
192681|NCT01591616|O18|Outcome|Vital Signs (Systolic), 150 Minutes Post-dose|
192682|NCT01591616|O17|Outcome|Vital Signs (Systolic), 140 Minutes Post-dose|
192683|NCT01591616|O16|Outcome|Vital Signs (Systolic), 130 Minutes Post-dose|
192684|NCT01591616|O15|Outcome|Vital Signs (Systolic), 120 Minutes Post-dose|
192685|NCT01591616|O14|Outcome|Vital Signs (Systolic), 110 Minutes Post-dose|
192686|NCT01591616|O13|Outcome|Vital Signs (Systolic), 100 Minutes Post-dose|
194340|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
192699|NCT01591616|O27|Outcome|Vital Signs (Pulse Rate), 240 Minutes Post-dose|
192700|NCT01591616|O26|Outcome|Vital Signs (Pulse Rate), 230 Minutes Post-dose|
192701|NCT01591616|O25|Outcome|Vital Signs (Pulse Rate), 220 Minutes Post-dose|
192702|NCT01591616|O24|Outcome|Vital Signs (Pulse Rate), 210 Minutes Post-dose|
192703|NCT01591616|O23|Outcome|Vital Signs (Pulse Rate), 200 Minutes Post-dose|
192704|NCT01591616|O22|Outcome|Vital Signs (Pulse Rate), 190 Minutes Post-dose|
192705|NCT01591616|O21|Outcome|Vital Signs (Pulse Rate), 180 Minutes Post-dose|
192706|NCT01591616|O20|Outcome|Vital Signs (Pulse Rate), 170 Minutes Post-dose|
192707|NCT01591616|O19|Outcome|Vital Signs (Pulse Rate), 160 Minutes Post-dose|
192708|NCT01591616|O18|Outcome|Vital Signs (Pulse Rate), 150 Minutes Post-dose|
192709|NCT01591616|O17|Outcome|Vital Signs (Pulse Rate), 140 Minutes Post-dose|
192710|NCT01591616|O16|Outcome|Vital Signs (Pulse Rate), 130 Minutes Post-dose|
192711|NCT01591616|O15|Outcome|Vital Signs (Pulse Rate), 120 Minutes Post-dose|
192712|NCT01591616|O14|Outcome|Vital Signs (Pulse Rate), 110 Minutes Post-dose|
192713|NCT01591616|O13|Outcome|Vital Signs (Pulse Rate), 100 Minutes Post-dose|
192714|NCT01591616|O12|Outcome|Vital Signs (Pulse Rate), 90 Minutes Post-dose|
192715|NCT01591616|O11|Outcome|Vital Signs (Pulse Rate), 80 Minutes Post-dose|
192716|NCT01591616|O10|Outcome|Vital Signs (Pulse Rate), 70 Minutes Post-dose|
192717|NCT01591616|O9|Outcome|Vital Signs (Pulse Rate), 60 Minutes Post-dose|
192718|NCT01591616|O8|Outcome|Vital Signs (Pulse Rate), 50 Minutes Post-dose|
192719|NCT01591616|O7|Outcome|Vital Signs (Pulse Rate), 40 Minutes Post-dose|
192720|NCT01591616|O6|Outcome|Vital Signs (Pulse Rate), 30 Minutes Post-dose|
192721|NCT01591616|O5|Outcome|Vital Signs (Pulse Rate), 20 Minutes Post-dose|
192722|NCT01591616|O4|Outcome|Vital Signs (Pulse Rate), 10 Minutes Post-dose|
192723|NCT01591616|O3|Outcome|Vital Signs (Pulse Rate), 0 Minutes Pre-dose|
192724|NCT01591616|O2|Outcome|Vital Signs (Pulse Rate), - 10 Minutes Pre-dose|
192725|NCT01591616|O1|Outcome|Vital Signs (Pulse Rate), - 20 Minutes Pre-dose|
192726|NCT01591616|O4|Outcome|O-toluidine Tmax|
192727|NCT01591616|O3|Outcome|2,6-xylidine Tmax|
192728|NCT01591616|O2|Outcome|Prilocaine Tmax|
192729|NCT01591616|O1|Outcome|Lidocaine Tmax|
192730|NCT01591616|O27|Outcome|% MetHemoglobin (MetHb) Time Point 240 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192731|NCT01591616|O26|Outcome|% MetHemoglobin (MetHb) Time Point 230 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192732|NCT01591616|O25|Outcome|% MetHemoglobin (MetHb) Time Point 220 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192733|NCT01591616|O24|Outcome|% MetHemoglobin (MetHb) Time Point 210 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192734|NCT01591616|O23|Outcome|% MetHemoglobin (MetHb) Time Point 200 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192735|NCT01591616|O22|Outcome|% MetHemoglobin (MetHb) Time Point 190 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192736|NCT01591616|O21|Outcome|% MetHemoglobin (MetHb) Time Point 180 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192737|NCT01591616|O20|Outcome|% MetHemoglobin (MetHb) Time Point 170 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192738|NCT01591616|O19|Outcome|% MetHemoglobin (MetHb) Time Point 160 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192739|NCT01591616|O18|Outcome|% MetHemoglobin (MetHb) Time Point 150 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192740|NCT01591616|O17|Outcome|% MetHemoglobin (MetHb) Time Point 140 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192741|NCT01591616|O16|Outcome|% MetHemoglobin (MetHb) Time Point 130 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192742|NCT01591616|O15|Outcome|% MetHemoglobin (MetHb) Time Point 120 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192743|NCT01591616|O14|Outcome|% MetHemoglobin (MetHb) Time Point 110 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192744|NCT01591616|O13|Outcome|% MetHemoglobin (MetHb) Time Point 100 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192745|NCT01591616|O12|Outcome|% MetHemoglobin (MetHb) Time Point 90 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192746|NCT01591616|O11|Outcome|% MetHemoglobin (MetHb) Time Point 80 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192747|NCT01591616|O10|Outcome|% MetHemoglobin (MetHb) Time Point 70 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192748|NCT01591616|O9|Outcome|% MetHemoglobin (MetHb) Time Point 60 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192749|NCT01591616|O8|Outcome|% MetHemoglobin (MetHb) Time Point 50 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192750|NCT01591616|O7|Outcome|% MetHemoglobin (MetHb) Time Point 40 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192751|NCT01591616|O6|Outcome|% MetHemoglobin (MetHb) Time Point 30 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192752|NCT01591616|O5|Outcome|% MetHemoglobin (MetHb) Time Point 20 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192753|NCT01591616|O4|Outcome|% MetHemoglobin (MetHb) Time Point 10 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192754|NCT01591616|O3|Outcome|% MetHemoglobin (MetHb) Time Point 0 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192755|NCT01591616|O2|Outcome|% MetHemoglobin (MetHb) Time Point -10 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192756|NCT01591616|O1|Outcome|% MetHemoglobin (MetHb) Time Point -20 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
192757|NCT01591616|O4|Outcome|O-toluidine Cmax|
192758|NCT01591616|O3|Outcome|2,6-xylidine Cmax|
192759|NCT01591616|O2|Outcome|Prilocaine Cmax|
192760|NCT01591616|O1|Outcome|Lidocaine Cmax|
192761|NCT01591616|E1|Reported Event|Adverse Events|
192762|NCT01591499|B3|Baseline|Total|Total of all reporting groups
192763|NCT01591499|B2|Baseline|Biofinity/Purevision Combination|Participants were randomized to wear either a Biofinity pair or an Purevision pair and then crossed over to the alternate lens pair. (Biofinity crossover to Purevision or Purevision crossover to Biofinity)
192764|NCT01591499|B1|Baseline|Biofinity/Air Optix Aqua Combination|Participants were randomized to wear either a Biofinity pair or an Air Optix pair and then crossed over to the alternate lens pair. (Biofinity crossover to Air Optix or Air Optix crossover to Biofinity)
192765|NCT01591499|P4|Participant Flow|Purevision Then Biofinity|"Randomized cross-over study to wear Biofinity Multifocal lenses or to wear either the Air Optix Aqual Multiocal lens (lenses allocated on a ratio of 1/0.5) or the PureVision Multifocal lens (lenses allocated on a ratio of 1/0.5).~First pair of lens evaluated and worn up to 24 days. Subjects are crossed over to second pair of lens. Second pair of lens evaluated and worn up to 24 days."
192766|NCT01591499|P3|Participant Flow|Biofinity Then Purevision|"Randomized cross-over study to wear Biofinity Multifocal lenses or to wear either the Air Optix Aqual Multiocal lens (lenses allocated on a ratio of 1/0.5) or the PureVision Multifocal lens (lenses allocated on a ratio of 1/0.5).~First pair of lens evaluated and worn up to 24 days. Subjects are crossed over to second pair of lens. Second pair of lens evaluated and worn up to 24 days."
192767|NCT01591499|P2|Participant Flow|Air Optix Then Biofinity|"Randomized cross-over study to wear Biofinity Multifocal lenses or to wear either the Air Optix Aqual Multiocal lens (lenses allocated on a ratio of 1/0.5) or the PureVision Multifocal lens (lenses allocated on a ratio of 1/0.5).~First pair of lens evaluated and worn up to 24 days. Subjects are crossed over to second pair of lens. Second pair of lens evaluated and worn up to 24 days."
192768|NCT01591499|P1|Participant Flow|Biofinity Then Air Optix|"Randomized cross-over study to wear Biofinity Multifocal lenses or to wear either the Air Optix Aqual Multiocal lens (lenses allocated on a ratio of 1/0.5) or the PureVision Multifocal lens (lenses allocated on a ratio of 1/0.5).~First pair of lens evaluated and worn up to 24 days. Subjects are crossed over to second pair of lens. Second pair of lens evaluated and worn up to 24 days."
192769|NCT01591499|O3|Outcome|Evaluated At Least One Lens|Population of patients having evaluated at least one lens pair
192770|NCT01591499|O2|Outcome|Biofinity/Purevision Combination|Participants were randomized to wear either a Biofinity pair or an Purevision pair and then crossed over to the alternate lens pair. (Biofinity crossover to Purevision) (Purevision crossover to Biofinity
192771|NCT01591499|O1|Outcome|Biofinity/Air Optix Combination|Participants were randomized to wear either a Biofinity pair or an Air Optix pair and then crossed over to the alternate lens pair. (Biofinity crossover to Air Optix) (Air Optix crossover to Biofinity)
192772|NCT01591499|O3|Outcome|Evaluated At Least One Lens|Population of patients having evaluated at least one lens pair.
192773|NCT01591499|O2|Outcome|Biofinity/Purevision Combination|Participants were randomized to wear either a Biofinity pair or an Purevision pair and then crossed over to the alternate lens pair. (Biofinity crossover to Purevision) (Purevision crossover to Biofinity
192774|NCT01591499|O1|Outcome|Biofinity/Air Optix Combination|Participants were randomized to wear either a Biofinity pair or an Air Optix pair and then crossed over to the alternate lens pair. (Biofinity crossover to Air Optix) (Air Optix crossover to Biofinity)
192775|NCT01591499|O3|Outcome|Purevision Multifocal|Clinical performance by lens (Purevision Multifocal)
192776|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Clinical performance by lens (Air Optix Aqua Multifocal)
192777|NCT01591499|O1|Outcome|Biofinity Multifocal|Clinical performance by lens (Biofinity Multifocal) tested at V3 or V5
192778|NCT01591499|O3|Outcome|Purevision Multifocal|Geometric performance by lens (Purevision Multifocal)
192779|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Geometric performance by lens (Air Optix Aqua Multifocal)
192780|NCT01591499|O1|Outcome|Biofinity Multifocal|Geometric performance by lens (Biofinity Multifocal) tested at V3 or V5
192781|NCT01591499|O3|Outcome|Purevision Multifocal|Geometric performance by lens (Purevision Multifocal)
192782|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Geometric performance by lens (Air Optix Aqua Multifocal)
192783|NCT01591499|O1|Outcome|Biofinity Multifocal|Geometric performance by lens (Biofinity Multifocal) tested at V3 or V5
192784|NCT01591499|O3|Outcome|Purevision Multifocal|Performance by lens (Purevision Multifocal)
192785|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Performance by lens (Air Optix Aqua Multifocal)
192786|NCT01591499|O1|Outcome|Biofinity Multifocal|Performance by lens (Biofinity Multifocal) tested at V3 or V5
192787|NCT01591499|O3|Outcome|Purevision Multifocal|Performance by lens (Purevision Multifocal)
192788|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Performance by lens (Air Optix Aqua Multifocal)
192789|NCT01591499|O1|Outcome|Biofinity Multifocal|Performance by lens (Biofinity Multifocal) tested at V3 or V5
192790|NCT01591499|O3|Outcome|Purevision Multifocal|Performance by lens (Purevision Multifocal)
192791|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Performance by lens (Air Optix Aqua Multifocal)
192792|NCT01591499|O1|Outcome|Biofinity Multifocal|Performance by lens (Biofinity Multifocal) tested at V3 or V5
192793|NCT01591499|O3|Outcome|Purevision Multifocal|Performance by lens (Purevision Multifocal)
192794|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Performance by lens (Air Optix Aqua Multifocal)
192795|NCT01591499|O1|Outcome|Biofinity Multifocal|Performance by lens (Biofinity Multifocal) tested at V3 or V5
192796|NCT01591499|O3|Outcome|Purevision Multifocal|Comfort performance by lens (Purevision Multifocal)
192797|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Comfort performance by lens (Air Optix Aqua Multifocal)
192798|NCT01591499|O1|Outcome|Biofinity Multifocal|Comfort performance by lens (Biofinity Multifocal) tested at V3 or V5
192799|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
192800|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
192801|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
192802|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
192803|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
192804|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
192805|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
192806|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
192807|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
192808|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
192809|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
192810|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at visit V3 or V5
192811|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
192812|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
192813|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
192814|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
192815|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
192816|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
192817|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
192818|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
192819|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
192820|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
192821|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
192822|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at visit V3 or V5
192823|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
192824|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
192825|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at visit V3 or V5
192826|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
192827|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
192828|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal)
192829|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
192830|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
192831|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
192832|NCT01591499|E1|Reported Event|Overall Study Population|Population of patients having evaluated at least one lens
192833|NCT01591460|B1|Baseline|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
192843|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
194341|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
192834|NCT01591460|P1|Participant Flow|Total Population|Treatment-naive participants with chronic hepatitis C (CHC) received treatment with peginterferon alfa-2a (PEG-IFN) 180 micrograms (mcg) subcutaneous (SC) once weekly, weight-based ribavirin (RBV) 1000 to 1200 milligrams (mg) orally (PO) daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a less than (<) 1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
192835|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
192836|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
192837|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
192838|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
192839|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
192840|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
192841|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
192842|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
192934|NCT01591382|O1|Outcome|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
192935|NCT01591382|O2|Outcome|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
194342|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
192844|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
192845|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
192846|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
192847|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
192848|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
192849|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
192850|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
192851|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
192852|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
192853|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
192854|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
192936|NCT01591382|O1|Outcome|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
192855|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
192856|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
192857|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
192858|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
192859|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
192860|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
192861|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
192862|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
192863|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
192864|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
192865|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
192937|NCT01591382|E2|Reported Event|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
192981|NCT01591044|P2|Participant Flow|Placebo|Placebo: 1 puff bid or 2 puffs bid
192866|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
192867|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
192868|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
192869|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
192870|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
192871|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
192872|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
192873|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
192874|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
192875|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
192876|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
192938|NCT01591382|E1|Reported Event|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
192939|NCT01591317|B4|Baseline|Total|Total of all reporting groups
192877|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
192878|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
192879|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
192880|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
192881|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
192882|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
192883|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
192884|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
192885|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
192886|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
192887|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
192940|NCT01591317|B3|Baseline|Prasugrel - 30 mg/5 mg|Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
192888|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
192889|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
192890|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
192891|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
192892|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
192893|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
192894|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
192895|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
192896|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
192897|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
192898|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
192941|NCT01591317|B2|Baseline|Prasugrel - 30 mg/7.5 mg|Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
192980|NCT01591044|P3|Participant Flow|R940343 1mg, 1 Puff Bid|"R343 1mg, 1 puff bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
192899|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
192900|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
192901|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
192902|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
192903|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
192904|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
192905|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
192906|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
192907|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
192908|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
192909|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
192942|NCT01591317|B1|Baseline|Prasugrel - 60 mg/10 mg|Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
192943|NCT01591317|P3|Participant Flow|Prasugrel - 30 mg/5 mg|Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
192944|NCT01591317|P2|Participant Flow|Prasugrel - 30 mg/7.5 mg|Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
192910|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
192911|NCT01591460|E2|Reported Event|Noncirrhotics (Safety)|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. Participants without liver cirrhosis, including those with transition to cirrhosis, were grouped separately in the safety analysis.
192912|NCT01591460|E1|Reported Event|Cirrhotics (Safety)|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. Participants with liver cirrhosis were grouped separately in the safety analysis.
192913|NCT01591408|B3|Baseline|Total|Total of all reporting groups
192914|NCT01591408|B2|Baseline|Sham EEG Biofeedback|"Subjects will receive feedback according to someone else's brain rhythms collected during a different session.~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
192915|NCT01591408|B1|Baseline|EEG Biofeedback|"Subjects will receive EEG biofeedback according to their own brain rhythms~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
192916|NCT01591408|P2|Participant Flow|Sham EEG Biofeedback|"Subjects will receive feedback according to someone else's brain rhythms collected during a different session.~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
192917|NCT01591408|P1|Participant Flow|EEG Biofeedback|"Subjects will receive EEG biofeedback according to their own brain rhythms~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
192918|NCT01591408|O2|Outcome|Sham EEG Biofeedback|"Subjects will receive feedback according to someone else's brain rhythms collected during a different session.~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
192919|NCT01591408|O1|Outcome|EEG Biofeedback|"Subjects will receive EEG biofeedback according to their own brain rhythms~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
192920|NCT01591408|E2|Reported Event|Sham EEG Biofeedback|"Subjects will receive feedback according to someone else's brain rhythms collected during a different session.~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
192921|NCT01591408|E1|Reported Event|EEG Biofeedback|"Subjects will receive EEG biofeedback according to their own brain rhythms~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
192922|NCT01591382|B3|Baseline|Total|Total of all reporting groups
192923|NCT01591382|B2|Baseline|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
192924|NCT01591382|B1|Baseline|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
192925|NCT01591382|P2|Participant Flow|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
192926|NCT01591382|P1|Participant Flow|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
192927|NCT01591382|O2|Outcome|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
192928|NCT01591382|O1|Outcome|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
192929|NCT01591382|O2|Outcome|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
192930|NCT01591382|O1|Outcome|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
192931|NCT01591382|O2|Outcome|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
192932|NCT01591382|O1|Outcome|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
192933|NCT01591382|O2|Outcome|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
192945|NCT01591317|P1|Participant Flow|Prasugrel - 60 mg/10 mg|Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
192946|NCT01591317|O3|Outcome|Prasugrel - 30 mg/5 mg|Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
192947|NCT01591317|O2|Outcome|Prasugrel - 30 mg/7.5 mg|Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
192948|NCT01591317|O1|Outcome|Prasugrel - 60 mg/10 mg|Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
192949|NCT01591317|O3|Outcome|Prasugrel 5 mg|Prasugrel 5 mg once a day orally for 10 days
192950|NCT01591317|O2|Outcome|Prasugrel 7.5 mg|Prasugrel 7.5 mg once a day orally for 10 days
192951|NCT01591317|O1|Outcome|Prasugrel 10 mg|Prasugrel 10 mg once a day orally for 10 days
192952|NCT01591317|O3|Outcome|Prasugrel 5 mg|Prasugrel 5 mg once a day orally for 10 days
192953|NCT01591317|O2|Outcome|Prasugrel 7.5 mg|Prasugrel 7.5 mg once a day orally for 10 days
192954|NCT01591317|O1|Outcome|Prasugrel 10 mg|Prasugrel 10 mg once a day orally for 10 days
192955|NCT01591317|O3|Outcome|Prasugrel 5 mg|Prasugrel 5 mg once a day orally for 10 days
192956|NCT01591317|O2|Outcome|Prasugrel 7.5 mg|Prasugrel 7.5 mg once a day orally for 10 days
192957|NCT01591317|O1|Outcome|Prasugrel 10 mg|Prasugrel 10 mg once a day orally for 10 days
192958|NCT01591317|O3|Outcome|Prasugrel - 30 mg/5 mg|Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
192959|NCT01591317|O2|Outcome|Prasugrel - 30 mg/7.5 mg|Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
192960|NCT01591317|O1|Outcome|Prasugrel - 60 mg/10 mg|Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
192961|NCT01591317|O2|Outcome|Prasugrel 30 mg|Prasugrel 30 mg loading dose given once orally
192962|NCT01591317|O1|Outcome|Prasugrel 60 mg|Prasugrel 60 mg loading dose given once orally
192963|NCT01591317|O2|Outcome|Prasugrel 30 mg|Prasugrel 30 mg loading dose given once orally
192964|NCT01591317|O1|Outcome|Prasugrel 60 mg|Prasugrel 60 mg loading dose given once orally
192965|NCT01591317|O2|Outcome|Prasugrel 30 mg|Prasugrel 30 mg loading dose given once orally
192966|NCT01591317|O1|Outcome|Prasugrel 60 mg|Prasugrel 60 mg loading dose given once orally
192967|NCT01591317|E3|Reported Event|Prasugrel - 30 mg/5 mg|Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
192968|NCT01591317|E2|Reported Event|Prasugrel - 30 mg/7.5 mg|Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
192969|NCT01591317|E1|Reported Event|Prasugrel - 60 mg/10 mg|Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
192970|NCT01591096|B1|Baseline|Tissue Plasminogen Activator|"All patients will receive study drug.~Tissue plasminogen activator (Activase®): Investigation labeled tPA will be obtained for all sites by the Core Pharmacy as commercially available recombinant tPA (Genentech as Activase®) for IV administration. The Bayesian method of toxicity probability intervals will be used to select one of the following three dose tiers (0.75, 0.9, 1.0 mg/kg) of IV tPA. The dose escalation for the two age groups (2-10, 11-17 years) will be performed independently. The maximum dose for each tier will be reached at a weight of 90 kg."
192971|NCT01591096|P1|Participant Flow|Tissue Plasminogen Activator|"All patients will receive study drug.~Tissue plasminogen activator (Activase®): Investigation labeled tPA will be obtained for all sites by the Core Pharmacy as commercially available recombinant tPA (Genentech as Activase®) for IV administration. The Bayesian method of toxicity probability intervals will be used to select one of the following three dose tiers (0.75, 0.9, 1.0 mg/kg) of IV tPA. The dose escalation for the two age groups (2-10, 11-17 years) will be performed independently. The maximum dose for each tier will be reached at a weight of 90 kg."
192972|NCT01591096|O1|Outcome|Tissue Plasminogen Activator|"All patients will receive study drug.~Tissue plasminogen activator (Activase®): Investigation labeled tPA will be obtained for all sites by the Core Pharmacy as commercially available recombinant tPA (Genentech as Activase®) for IV administration. The Bayesian method of toxicity probability intervals will be used to select one of the following three dose tiers (0.75, 0.9, 1.0 mg/kg) of IV tPA. The dose escalation for the two age groups (2-10, 11-17 years) will be performed independently. The maximum dose for each tier will be reached at a weight of 90 kg."
192973|NCT01591096|O1|Outcome|Tissue Plasminogen Activator|"All patients will receive study drug.~Tissue plasminogen activator (Activase®): Investigation labeled tPA will be obtained for all sites by the Core Pharmacy as commercially available recombinant tPA (Genentech as Activase®) for IV administration. The Bayesian method of toxicity probability intervals will be used to select one of the following three dose tiers (0.75, 0.9, 1.0 mg/kg) of IV tPA. The dose escalation for the two age groups (2-10, 11-17 years) will be performed independently. The maximum dose for each tier will be reached at a weight of 90 kg."
192974|NCT01591096|O1|Outcome|Tissue Plasminogen Activator|"All patients will receive study drug.~Tissue plasminogen activator (Activase®): Investigation labeled tPA will be obtained for all sites by the Core Pharmacy as commercially available recombinant tPA (Genentech as Activase®) for IV administration. The Bayesian method of toxicity probability intervals will be used to select one of the following three dose tiers (0.75, 0.9, 1.0 mg/kg) of IV tPA. The dose escalation for the two age groups (2-10, 11-17 years) will be performed independently. The maximum dose for each tier will be reached at a weight of 90 kg."
192975|NCT01591096|E1|Reported Event|Tissue Plasminogen Activator|"All patients will receive study drug.~Tissue plasminogen activator (Activase®): Investigation labeled tPA will be obtained for all sites by the Core Pharmacy as commercially available recombinant tPA (Genentech as Activase®) for IV administration. The Bayesian method of toxicity probability intervals will be used to select one of the following three dose tiers (0.75, 0.9, 1.0 mg/kg) of IV tPA. The dose escalation for the two age groups (2-10, 11-17 years) will be performed independently. The maximum dose for each tier will be reached at a weight of 90 kg."
192976|NCT01591044|B4|Baseline|Total|Total of all reporting groups
192977|NCT01591044|B3|Baseline|R940343 1mg, 1 Puff Bid|"R343 1mg, 1 puff bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
192978|NCT01591044|B2|Baseline|Placebo|Placebo: 1, 1 puff bid or 2, 2 puffs bid
192979|NCT01591044|B1|Baseline|R940343 2mg, 2 Puffs Bid|"R343 2mg, 2 puffs bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
192982|NCT01591044|P1|Participant Flow|R940343 2mg, 2 Puffs Bid|"R343 2mg, 2 puffs bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
192983|NCT01591044|O3|Outcome|R940343 1mg, 1 Puff Bid|"R343 1mg, 1 puff bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
192984|NCT01591044|O2|Outcome|Placebo|Placebo: 1, 1 puff bid or 2, 2 puffs bid
192985|NCT01591044|O1|Outcome|R940343 2mg, 2 Puffs Bid|"R343 2mg, 2 puffs bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
192986|NCT01591044|E3|Reported Event|R940343 1mg, 1 Puff Bid|"R343 1mg, 1 puff bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
192987|NCT01591044|E2|Reported Event|Placebo|Placebo: 1, 1 puff bid or 2, 2 puffs bid
192988|NCT01591044|E1|Reported Event|R940343 2mg, 2 Puffs Bid|"R343 2mg, 2 puffs bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
192989|NCT01591018|B3|Baseline|Total|Total of all reporting groups
192990|NCT01591018|B2|Baseline|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
192991|NCT01591018|B1|Baseline|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
192992|NCT01591018|P2|Participant Flow|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
192993|NCT01591018|P1|Participant Flow|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
192994|NCT01591018|O2|Outcome|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
192995|NCT01591018|O1|Outcome|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
192996|NCT01591018|O2|Outcome|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
192997|NCT01591018|O1|Outcome|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
192998|NCT01591018|O2|Outcome|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
192999|NCT01591018|O1|Outcome|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
193000|NCT01591018|E2|Reported Event|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
193001|NCT01591018|E1|Reported Event|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
193002|NCT01591005|B5|Baseline|Total|Total of all reporting groups
193003|NCT01591005|B4|Baseline|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
193004|NCT01591005|B3|Baseline|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
193005|NCT01591005|B2|Baseline|CEA Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
193006|NCT01591005|B1|Baseline|CEA With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
193007|NCT01591005|P4|Participant Flow|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
193008|NCT01591005|P3|Participant Flow|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
193009|NCT01591005|P2|Participant Flow|CEA Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
193010|NCT01591005|P1|Participant Flow|CEA With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
193011|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
193012|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
193013|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
193097|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
194343|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
193014|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
193015|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
193016|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
193017|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
193018|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
193019|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
193020|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
193021|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
193022|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
193023|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
193024|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
193025|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
193026|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
193027|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
193028|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
193029|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
193030|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
193031|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
193032|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
193033|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
193034|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
193035|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
193036|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
193037|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
193038|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
193039|NCT01591005|E4|Reported Event|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
193040|NCT01591005|E3|Reported Event|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
193041|NCT01591005|E2|Reported Event|CEA Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
193042|NCT01591005|E1|Reported Event|CEA With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
193043|NCT01590979|B3|Baseline|Total|Total of all reporting groups
193044|NCT01590979|B2|Baseline|Placebo|"Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)~Placebo: two times a day, 12 hour intervals"
193045|NCT01590979|B1|Baseline|Ranolazine|"The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.~Ranolazine: 1000mg, two times a day, 12 hour intervals"
193046|NCT01590979|P2|Participant Flow|Placebo|"Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)~Placebo: two times a day, 12 hour intervals"
193047|NCT01590979|P1|Participant Flow|Ranolazine|"The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.~Ranolazine: 1000mg, two times a day, 12 hour intervals"
193048|NCT01590979|O2|Outcome|Placebo|"Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)~Placebo: two times a day, 12 hour intervals"
193049|NCT01590979|O1|Outcome|Ranolazine|"The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.~Ranolazine: 1000mg, two times a day, 12 hour intervals"
193050|NCT01590979|E2|Reported Event|Placebo|"Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)~Placebo: two times a day, 12 hour intervals"
193051|NCT01590979|E1|Reported Event|Ranolazine|"The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.~Ranolazine: 1000mg, two times a day, 12 hour intervals"
193052|NCT01590888|B4|Baseline|Total|Total of all reporting groups
193053|NCT01590888|B3|Baseline|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
193054|NCT01590888|B2|Baseline|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
193055|NCT01590888|B1|Baseline|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
193056|NCT01590888|P3|Participant Flow|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
193057|NCT01590888|P2|Participant Flow|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
193058|NCT01590888|P1|Participant Flow|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
193059|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
193060|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
193061|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
193062|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
193063|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
193064|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
193065|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
193066|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
193067|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
193068|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
193069|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
193070|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
193071|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
193072|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
193073|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
193074|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
193075|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
193076|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
193077|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
193078|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
193079|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
193080|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
193081|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
193082|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
193083|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
193084|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
193085|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
193086|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
193087|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
193088|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
193089|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
193090|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
193091|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
193092|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
193093|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
193094|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
193095|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
193096|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
193153|NCT01590810|O6|Outcome|Panel B – Placebo|Single dose of placebo
193098|NCT01590888|E3|Reported Event|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
193099|NCT01590888|E2|Reported Event|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
193100|NCT01590888|E1|Reported Event|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
193101|NCT01590875|B3|Baseline|Total|Total of all reporting groups
193102|NCT01590875|B2|Baseline|Observation Arm|25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This will serve as the control arm.
193103|NCT01590875|B1|Baseline|Adenosine Arm|"25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose.~Adenosine arm: In the adenosine arm, 25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose. In the observation arm, 25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation."
193104|NCT01590875|P2|Participant Flow|Observation Arm|25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This will serve as the control arm.
193105|NCT01590875|P1|Participant Flow|Adenosine Arm|"25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose.~Adenosine arm: In the adenosine arm, 25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose. In the observation arm, 25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation."
193106|NCT01590875|O2|Outcome|Observation Arm|"10 patients were randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This served as the control arm.~Of these 10 patients, none demonstrated pulmonary vein reconnection during the 10 minute period of observation."
193107|NCT01590875|O1|Outcome|Adenosine Arm|"10 patients were randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, we monitored for pulmonary vein reconnection, second dose of adenosine was given only if no reconnection after initial dose.~Of these 10 patients, 3 patients were noted to have pulmonary vein reconnection post initial dose of adenosine in at least one pulmonary vein. No patient demonstrated pulmonary vein reconnection with second dose of adenosine."
193108|NCT01590875|O2|Outcome|Observation Arm|25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This will serve as the control arm.
193109|NCT01590875|O1|Outcome|Adenosine Arm|"25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose.~Adenosine arm: In the adenosine arm, 25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose. In the observation arm, 25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation."
193110|NCT01590875|E2|Reported Event|Observation Arm|10 patients were be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This served as the control arm.
193111|NCT01590875|E1|Reported Event|Adenosine Arm|10 patients were randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, we monitored for pulmonary vein reconnection, second dose of adenosine was given to the 7 patients without reconnection after initial dose.
193112|NCT01590810|B6|Baseline|Total|Total of all reporting groups
193113|NCT01590810|B5|Baseline|Panel D – Placebo|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
193114|NCT01590810|B4|Baseline|Panel D – MK-8150 50 to 200 mg|Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
193115|NCT01590810|B3|Baseline|Panel C – MK-8150 5 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
193116|NCT01590810|B2|Baseline|Panel B – MK-8150 4 to 120 mg/Placebo|Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
193117|NCT01590810|B1|Baseline|Panel A – MK-8150 2 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
193118|NCT01590810|P5|Participant Flow|Panel D – Placebo|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
193119|NCT01590810|P4|Participant Flow|Panel D – MK-8150 50 to 200 mg|Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
193120|NCT01590810|P3|Participant Flow|Panel C – MK-8150 5 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
193121|NCT01590810|P2|Participant Flow|Panel B – MK-8150 4 to 120 mg/Placebo|Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
193122|NCT01590810|P1|Participant Flow|Panel A – MK-8150 2 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
193123|NCT01590810|O5|Outcome|Panel D – Placebo|Single dose of placebo
193124|NCT01590810|O4|Outcome|Panel D – MK-8150 200 mg|Single dose of MK-8150 200 mg
193125|NCT01590810|O3|Outcome|Panel D – MK-8150 100 mg|Single dose of MK-8150 100 mg
193126|NCT01590810|O2|Outcome|Panel D – MK-8150 50 mg (Repeat Dose)|Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
193127|NCT01590810|O1|Outcome|Panel D – MK-8150 50 mg|Single dose of MK-8150 50 mg
193128|NCT01590810|O4|Outcome|Panel C – Placebo|Single dose of placebo
193129|NCT01590810|O3|Outcome|Panel C – MK-8150 90 mg|Single dose of MK-8150 90 mg
193130|NCT01590810|O2|Outcome|Panel C – MK-8150 24 mg|Single dose of MK-8150 24 mg
193131|NCT01590810|O1|Outcome|Panel C – MK-8150 5 mg|Single dose of MK-8150 5 mg
193132|NCT01590810|O6|Outcome|Panel B – Placebo|Single dose of placebo
193133|NCT01590810|O5|Outcome|Panel B – MK-8150 120 mg (Repeat Dose)|Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
193134|NCT01590810|O4|Outcome|Panel B – MK-8150 120 mg|Single dose of MK-8150 120 mg
193135|NCT01590810|O3|Outcome|Panel B – MK-8150 45 mg|Single dose of MK-8150 45 mg
193136|NCT01590810|O2|Outcome|Panel B – MK-8150 12 mg|Single dose of MK-8150 12 mg
193137|NCT01590810|O1|Outcome|Panel B – MK-8150 4 mg|Single dose of MK-8150 4 mg
193138|NCT01590810|O6|Outcome|Panel A – Placebo|Single dose of placebo
193139|NCT01590810|O5|Outcome|Panel A – MK-8150 90 mg|Single dose of MK-8150 90 mg
193140|NCT01590810|O4|Outcome|Panel A – MK-8150 24 mg (Fed Condition)|Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
193141|NCT01590810|O3|Outcome|Panel A – MK-8150 24 mg|Single dose of MK-8150 24 mg
193142|NCT01590810|O2|Outcome|Panel A – MK-8150 6 mg|Single dose of MK-8150 6 mg
193143|NCT01590810|O1|Outcome|Panel A – MK-8150 2 mg|Single dose of MK-8150 2 mg
193144|NCT01590810|O5|Outcome|Panel D – Placebo|Single dose of placebo
193145|NCT01590810|O4|Outcome|Panel D – MK-8150 200 mg|Single dose of MK-8150 200 mg
193146|NCT01590810|O3|Outcome|Panel D – MK-8150 100 mg|Single dose of MK-8150 100 mg
193147|NCT01590810|O2|Outcome|Panel D – MK-8150 50 mg (Repeat Dose)|Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
193148|NCT01590810|O1|Outcome|Panel D – MK-8150 50 mg|Single dose of MK-8150 50 mg
193149|NCT01590810|O4|Outcome|Panel C – Placebo|Single dose of placebo
193150|NCT01590810|O3|Outcome|Panel C – MK-8150 90 mg|Single dose of MK-8150 90 mg
193151|NCT01590810|O2|Outcome|Panel C – MK-8150 24 mg|Single dose of MK-8150 24 mg
193152|NCT01590810|O1|Outcome|Panel C – MK-8150 5 mg|Single dose of MK-8150 5 mg
193154|NCT01590810|O5|Outcome|Panel B – MK-8150 120 mg (Repeat Dose)|Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
193155|NCT01590810|O4|Outcome|Panel B – MK-8150 120 mg|Single dose of MK-8150 120 mg
193156|NCT01590810|O3|Outcome|Panel B – MK-8150 45 mg|Single dose of MK-8150 45 mg
193157|NCT01590810|O2|Outcome|Panel B – MK-8150 12 mg|Single dose of MK-8150 12 mg
193158|NCT01590810|O1|Outcome|Panel B – MK-8150 4 mg|Single dose of MK-8150 4 mg
193159|NCT01590810|O6|Outcome|Panel A – Placebo|Single dose of placebo
193160|NCT01590810|O5|Outcome|Panel A – MK-8150 90 mg|Single dose of MK-8150 90 mg
193161|NCT01590810|O4|Outcome|Panel A – MK-8150 24 mg (Fed Condition)|Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
193162|NCT01590810|O3|Outcome|Panel A – MK-8150 24 mg|Single dose of MK-8150 24 mg
193163|NCT01590810|O2|Outcome|Panel A – MK-8150 6 mg|Single dose of MK-8150 6 mg
193164|NCT01590810|O1|Outcome|Panel A – MK-8150 2 mg|Single dose of MK-8150 2 mg
193165|NCT01590810|O5|Outcome|Panel D – Placebo|Single dose of placebo
193166|NCT01590810|O4|Outcome|Panel D – MK-8150 200 mg|Single dose of MK-8150 200 mg
193167|NCT01590810|O3|Outcome|Panel D – MK-8150 100 mg|Single dose of MK-8150 100 mg
193168|NCT01590810|O2|Outcome|Panel D – MK-8150 50 mg (Repeat Dose)|Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
193169|NCT01590810|O1|Outcome|Panel D – MK-8150 50 mg|Single dose of MK-8150 50 mg
193170|NCT01590810|O4|Outcome|Panel C – Placebo|Single dose of placebo
193171|NCT01590810|O3|Outcome|Panel C – MK-8150 90 mg|Single dose of MK-8150 90 mg
193172|NCT01590810|O2|Outcome|Panel C – MK-8150 24 mg|Single dose of MK-8150 24 mg
193173|NCT01590810|O1|Outcome|Panel C – MK-8150 5 mg|Single dose of MK-8150 5 mg
193174|NCT01590810|O6|Outcome|Panel B – Placebo|Single dose of placebo
193175|NCT01590810|O5|Outcome|Panel B – MK-8150 120 mg (Repeat Dose)|Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
193176|NCT01590810|O4|Outcome|Panel B – MK-8150 120 mg|Single dose of MK-8150 120 mg
193177|NCT01590810|O3|Outcome|Panel B – MK-8150 45 mg|Single dose of MK-8150 45 mg
193178|NCT01590810|O2|Outcome|Panel B – MK-8150 12 mg|Single dose of MK-8150 12 mg
193179|NCT01590810|O1|Outcome|Panel B – MK-8150 4 mg|Single dose of MK-8150 4 mg
193180|NCT01590810|O6|Outcome|Panel A – Placebo|Single dose of placebo
193181|NCT01590810|O5|Outcome|Panel A – MK-8150 90 mg|Single dose of MK-8150 90 mg
193182|NCT01590810|O4|Outcome|Panel A – MK-8150 24 mg (Fed Condition)|Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
193183|NCT01590810|O3|Outcome|Panel A – MK-8150 24 mg|Single dose of MK-8150 24 mg
193184|NCT01590810|O2|Outcome|Panel A – MK-8150 6 mg|Single dose of MK-8150 6 mg
193185|NCT01590810|O1|Outcome|Panel A – MK-8150 2 mg|Single dose of MK-8150 2 mg
193186|NCT01590810|O5|Outcome|Panel D – Placebo|Single dose of placebo
193187|NCT01590810|O4|Outcome|Panel D – MK-8150 200 mg|Single dose of MK-8150 200 mg
193188|NCT01590810|O3|Outcome|Panel D – MK-8150 100 mg|Single dose of MK-8150 100 mg
193189|NCT01590810|O2|Outcome|Panel D – MK-8150 50 mg (Repeat Dose)|Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
193190|NCT01590810|O1|Outcome|Panel D – MK-8150 50 mg|Single dose of MK-8150 50 mg
193191|NCT01590810|O4|Outcome|Panel C – Placebo|Single dose of placebo
193192|NCT01590810|O3|Outcome|Panel C – MK-8150 90 mg|Single dose of MK-8150 90 mg
193193|NCT01590810|O2|Outcome|Panel C – MK-8150 24 mg|Single dose of MK-8150 24 mg
193194|NCT01590810|O1|Outcome|Panel C – MK-8150 5 mg|Single dose of MK-8150 5 mg
193195|NCT01590810|O6|Outcome|Panel B – Placebo|Single dose of placebo
193196|NCT01590810|O5|Outcome|Panel B – MK-8150 120 mg (Repeat Dose)|Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
193197|NCT01590810|O4|Outcome|Panel B – MK-8150 120 mg|Single dose of MK-8150 120 mg
193198|NCT01590810|O3|Outcome|Panel B – MK-8150 45 mg|Single dose of MK-8150 45 mg
193199|NCT01590810|O2|Outcome|Panel B – MK-8150 12 mg|Single dose of MK-8150 12 mg
193200|NCT01590810|O1|Outcome|Panel B – MK-8150 4 mg|Single dose of MK-8150 4 mg
193201|NCT01590810|O6|Outcome|Panel A – Placebo|Single dose of placebo
193202|NCT01590810|O5|Outcome|Panel A – MK-8150 90 mg|Single dose of MK-8150 90 mg
193203|NCT01590810|O4|Outcome|Panel A – MK-8150 24 mg (Fed Condition)|Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
193204|NCT01590810|O3|Outcome|Panel A – MK-8150 24 mg|Single dose of MK-8150 24 mg
193205|NCT01590810|O2|Outcome|Panel A – MK-8150 6 mg|Single dose of MK-8150 6 mg
193206|NCT01590810|O1|Outcome|Panel A – MK-8150 2 mg|Single dose of MK-8150 2 mg
193207|NCT01590810|O5|Outcome|Panel D – Placebo|Single dose of placebo
193208|NCT01590810|O4|Outcome|Panel D – MK-8150 200 mg|Single dose of MK-8150 200 mg
193209|NCT01590810|O3|Outcome|Panel D – MK-8150 100 mg|Single dose of MK-8150 100 mg
193210|NCT01590810|O2|Outcome|Panel D – MK-8150 50 mg (Repeat Dose)|Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
193211|NCT01590810|O1|Outcome|Panel D – MK-8150 50 mg|Single dose of MK-8150 50 mg
193212|NCT01590810|O4|Outcome|Panel C – Placebo|Single dose of placebo
193213|NCT01590810|O3|Outcome|Panel C – MK-8150 90 mg|Single dose of MK-8150 90 mg
193214|NCT01590810|O2|Outcome|Panel C – MK-8150 24 mg|Single dose of MK-8150 24 mg
193215|NCT01590810|O1|Outcome|Panel C – MK-8150 5 mg|Single dose of MK-8150 5 mg
193216|NCT01590810|O6|Outcome|Panel B – Placebo|Single dose of placebo
193217|NCT01590810|O5|Outcome|Panel B – MK-8150 120 mg (Repeat Dose)|Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
193218|NCT01590810|O4|Outcome|Panel B – MK-8150 120 mg|Single dose of MK-8150 120 mg
193219|NCT01590810|O3|Outcome|Panel B – MK-8150 45 mg|Single dose of MK-8150 45 mg
193220|NCT01590810|O2|Outcome|Panel B – MK-8150 12 mg|Single dose of MK-8150 12 mg
193221|NCT01590810|O1|Outcome|Panel B – MK-8150 4 mg|Single dose of MK-8150 4 mg
193222|NCT01590810|O6|Outcome|Panel A – Placebo|Single dose of placebo
193223|NCT01590810|O5|Outcome|Panel A – MK-8150 90 mg|Single dose of MK-8150 90 mg
193224|NCT01590810|O4|Outcome|Panel A – MK-8150 24 mg (Fed Condition)|Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
193225|NCT01590810|O3|Outcome|Panel A – MK-8150 24 mg|Single dose of MK-8150 24 mg
193226|NCT01590810|O2|Outcome|Panel A – MK-8150 6 mg|Single dose of MK-8150 6 mg
193227|NCT01590810|O1|Outcome|Panel A – MK-8150 2 mg|Single dose of MK-8150 2 mg
193228|NCT01590810|O5|Outcome|Panel D – Placebo|Single dose of placebo
193229|NCT01590810|O4|Outcome|Panel D – MK-8150 200 mg|Single dose of MK-8150 200 mg
193230|NCT01590810|O3|Outcome|Panel D – MK-8150 100 mg|Single dose of MK-8150 100 mg
193231|NCT01590810|O2|Outcome|Panel D – MK-8150 50 mg (Repeat Dose)|Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
193232|NCT01590810|O1|Outcome|Panel D – MK-8150 50 mg|Single dose of MK-8150 50 mg
193233|NCT01590810|O4|Outcome|Panel C – Placebo|Single dose of placebo
193234|NCT01590810|O3|Outcome|Panel C – MK-8150 90 mg|Single dose of MK-8150 90 mg
193235|NCT01590810|O2|Outcome|Panel C – MK-8150 24 mg|Single dose of MK-8150 24 mg
193236|NCT01590810|O1|Outcome|Panel C – MK-8150 5 mg|Single dose of MK-8150 5 mg
193237|NCT01590810|O6|Outcome|Panel B – Placebo|Single dose of placebo
193238|NCT01590810|O5|Outcome|Panel B – MK-8150 120 mg (Repeat Dose)|Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
193239|NCT01590810|O4|Outcome|Panel B – MK-8150 120 mg|Single dose of MK-8150 120 mg
193240|NCT01590810|O3|Outcome|Panel B – MK-8150 45 mg|Single dose of MK-8150 45 mg
193241|NCT01590810|O2|Outcome|Panel B – MK-8150 12 mg|Single dose of MK-8150 12 mg
193242|NCT01590810|O1|Outcome|Panel B – MK-8150 4 mg|Single dose of MK-8150 4 mg
193243|NCT01590810|O6|Outcome|Panel A – Placebo|Single dose of placebo
193244|NCT01590810|O5|Outcome|Panel A – MK-8150 90 mg|Single dose of MK-8150 90 mg
193245|NCT01590810|O4|Outcome|Panel A – MK-8150 24 mg (Fed Condition)|Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
193246|NCT01590810|O3|Outcome|Panel A – MK-8150 24 mg|Single dose of MK-8150 24 mg
193247|NCT01590810|O2|Outcome|Panel A – MK-8150 6 mg|Single dose of MK-8150 6 mg
193248|NCT01590810|O1|Outcome|Panel A – MK-8150 2 mg|Single dose of MK-8150 2 mg
193249|NCT01590810|O5|Outcome|Panel D – Placebo|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
193250|NCT01590810|O4|Outcome|Panel D – MK-8150 50 to 200 mg|Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
193251|NCT01590810|O3|Outcome|Panel C – MK-8150 5 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
193252|NCT01590810|O2|Outcome|Panel B – MK-8150 4 to 120 mg/Placebo|Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
193266|NCT01590797|B1|Baseline|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
193293|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
194344|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
193253|NCT01590810|O1|Outcome|Panel A – MK-8150 2 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
193254|NCT01590810|O5|Outcome|Panel D – Placebo|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
193255|NCT01590810|O4|Outcome|Panel D – MK-8150 50 to 200 mg|Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
193256|NCT01590810|O3|Outcome|Panel C – MK-8150 5 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
193257|NCT01590810|O2|Outcome|Panel B – MK-8150 4 to 120 mg/Placebo|Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
193258|NCT01590810|O1|Outcome|Panel A – MK-8150 2 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
193259|NCT01590810|E5|Reported Event|Panel D – Placebo|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
193260|NCT01590810|E4|Reported Event|Panel D – MK-8150 50 to 200 mg|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
193261|NCT01590810|E3|Reported Event|Panel C – MK-8150 5 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
193262|NCT01590810|E2|Reported Event|Panel B – MK-8150 4 to 120 mg/Placebo|Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
193263|NCT01590810|E1|Reported Event|Panel A – MK-8150 2 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
193264|NCT01590797|B3|Baseline|Total|Total of all reporting groups
193265|NCT01590797|B2|Baseline|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
193267|NCT01590797|P2|Participant Flow|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
193268|NCT01590797|P1|Participant Flow|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
193269|NCT01590797|O2|Outcome|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
193270|NCT01590797|O1|Outcome|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
193271|NCT01590797|O2|Outcome|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
193272|NCT01590797|O1|Outcome|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
193273|NCT01590797|O2|Outcome|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
193274|NCT01590797|O1|Outcome|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
193275|NCT01590797|O2|Outcome|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
193276|NCT01590797|O1|Outcome|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
193277|NCT01590797|O2|Outcome|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
193278|NCT01590797|O1|Outcome|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
193279|NCT01590797|E2|Reported Event|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
193280|NCT01590797|E1|Reported Event|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
193281|NCT01590771|B3|Baseline|Total|Total of all reporting groups
193282|NCT01590771|B2|Baseline|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193283|NCT01590771|B1|Baseline|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193284|NCT01590771|P2|Participant Flow|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193285|NCT01590771|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193286|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193287|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193288|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193289|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193290|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193291|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193292|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193509|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193294|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193295|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193296|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193297|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193298|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193299|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193300|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193301|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193302|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193303|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193304|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193305|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193306|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193307|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193308|NCT01590771|E2|Reported Event|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193309|NCT01590771|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
193310|NCT01590758|B3|Baseline|Total|Total of all reporting groups
193311|NCT01590758|B2|Baseline|Topical Placebo Control|"Topical placebo cream: 14 days of treatment~Standard wound care: 28-day trial period"
193312|NCT01590758|B1|Baseline|Topical Pexiganan Cream 0.8%|"Topical pexiganan cream 0.8%: 14 days of treatment~Standard wound care: 28-day trial period"
193313|NCT01590758|P2|Participant Flow|Topical Placebo Control|"Topical placebo cream: 14 days of treatment + 14 days of follow-up (28-day trial period)~Standard wound care: 28-day trial period"
193314|NCT01590758|P1|Participant Flow|Topical Pexiganan Cream 0.8%|"Topical pexiganan cream 0.8%: 14 days of treatment + 14 days of follow-up (28-day trial period)~Standard wound care: 28-day trial period"
193315|NCT01590758|O2|Outcome|Topical Placebo Control|Topical placebo cream: 14 days of treatment
193316|NCT01590758|O1|Outcome|Topical Pexiganan Cream 0.8%|Topical pexiganan cream 0.8%: 14 days of treatment
193317|NCT01590758|O2|Outcome|Topical Placebo Control|Topical placebo cream: 14 days of treatment
193318|NCT01590758|O1|Outcome|Topical Pexiganan Cream 0.8%|Topical pexiganan cream 0.8%: 14 days of treatment
193319|NCT01590758|O2|Outcome|Topical Placebo Control|Topical placebo cream: 14 days of treatment
193320|NCT01590758|O1|Outcome|Topical Pexiganan Cream 0.8%|Topical pexiganan cream 0.8%: 14 days of treatment
193321|NCT01590758|E2|Reported Event|Topical Placebo Control|Topical placebo cream: 14 days of treatment
193322|NCT01590758|E1|Reported Event|Topical Pexiganan Cream 0.8%|Topical pexiganan cream 0.8%: 14 days of treatment
193323|NCT01590563|B1|Baseline|SCu300A IUB|Insertion of a spherical IUD (intrauterine device) with one year follow-up
193324|NCT01590563|P1|Participant Flow|SCu300A IUB|Insertion of a spherical IUD (intrauterine device) with one year follow-up
193325|NCT01590563|O1|Outcome|SCu300A IUB|Insertion of a spherical IUD (intrauterine device) with one year follow-up
193326|NCT01590563|O1|Outcome|SCu300A IUB|Insertion of a spherical IUD (intrauterine device) with one year follow-up
193327|NCT01590563|O1|Outcome|Investigated Device Group|Group inserted the investigated device - the IUB SCu300A
193328|NCT01590563|E1|Reported Event|SCu300A IUB|Insertion of a spherical IUD (intrauterine device) with one year follow-up
193329|NCT01590550|B1|Baseline|Observational|All patients receiving acute HD during the study period
193330|NCT01590550|P1|Participant Flow|Observational|All patients receiving acute HD during the study period
193331|NCT01590550|O1|Outcome|Observational|All patients receiving acute HD during the study period 6/118 (5%) treatments with circuit or catheter clotting
193332|NCT01590550|O1|Outcome|Observational|All patients receiving acute HD during the study period
193333|NCT01590550|O1|Outcome|Observational|All patients receiving acute HD during the study period 6/118 (5%) treatments with circuit or catheter clotting
193334|NCT01590550|E1|Reported Event|Observational|All patients receiving acute HD during the study period
193335|NCT01590394|B1|Baseline|Pancreatic Cancer Patients|A large plastic biliary stent was placed in the bile duct for bile duct obstruction.
193336|NCT01590394|P1|Participant Flow|Pancreatic Cancer Patients|A large plastic biliary stent was placed in the bile duct for bile duct obstruction.
193337|NCT01590394|O1|Outcome|Pancreatic Cancer Patients|A large plastic biliary stent was placed in the bile duct for bile duct obstruction.
193338|NCT01590394|E1|Reported Event|Pancreatic Cancer Patients|A large plastic biliary stent was placed in the bile duct for bile duct obstruction.
193339|NCT01590264|B1|Baseline|Bimodal rTMS|"Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)~Stimulation Settings:~DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000~TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000"
193340|NCT01590264|P1|Participant Flow|Bimodal rTMS|"Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)~Stimulation Settings:~DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000~TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000"
193341|NCT01590264|O1|Outcome|Bimodal rTMS|"Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)~Stimulation Settings:~DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000~TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000"
193342|NCT01590264|O1|Outcome|Bimodal rTMS|"Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)~Stimulation Settings:~DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000~TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000"
193343|NCT01590264|E1|Reported Event|Bimodal rTMS|"Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)~Stimulation Settings:~DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000~TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000"
193344|NCT01590238|B1|Baseline|Treatment With PRFM|"Subjects with androgenetic alopecia clinically diagnosed were treated monthly 3 times with intradermal injections of PRFM into bald/balding scalp. Post-treatment hair density index measured and compared to hair density index measured prior to treatment for each subject.~PRFM treatment: Study participants are treated in the initial visit, and at the 1 and 2 month follow-up visit. 4-8 cc of autologous platelet rich fibrin matrix (PRFM) is isolated from 9-18 cc of peripheral blood. PRFM is then injected intradermally in 0.10 cc aliquots in areas of alopecia for each treatment."
193345|NCT01590238|P1|Participant Flow|Treatment With PRFM|"Subjects treated monthly 3 times with intradermal injections of PRFM into bald/balding scalp. Post-treatment hair density index measured and compared to hair density index measured prior to treatment for each subject.~PRFM treatment: Study participants are treated in the initial visit, and at the 1 and 2 month follow-up visit. 4-8 cc of autologous platelet rich fibrin matrix (PRFM) is isolated from 9-18 cc of peripheral blood. PRFM is then injected intradermally in 0.10 cc aliquots in areas of alopecia for each treatment."
193346|NCT01590238|O1|Outcome|Treatment With PRFM|Subjects with androgenetic alopecia clinically diagnosed were treated monthly 3 times with intradermal injections of PRFM into bald/balding scalp. Post-treatment hair density index measured (6 months after initial treatment) and compared to hair density index measured prior to treatment for each subject.
193347|NCT01590238|E1|Reported Event|Treatment With PRFM|"Subjects with androgenetic alopecia clinically diagnosed were treated monthly 3 times with intradermal injections of PRFM into bald/balding scalp. Post-treatment hair density index measured and compared to hair density index measured prior to treatment for each subject.~PRFM treatment: Study participants are treated in the initial visit, and at the 1 and 2 month follow-up visit. 4-8 cc of autologous platelet rich fibrin matrix (PRFM) is isolated from 9-18 cc of peripheral blood. PRFM is then injected intradermally in 0.10 cc aliquots in areas of alopecia for each treatment."
193348|NCT01590212|B4|Baseline|Total|Total of all reporting groups
193349|NCT01590212|B3|Baseline|Care as Usual (CAU)|Participants received care in line with local guidelines.
193350|NCT01590212|B2|Baseline|Chill-out in Pregnancy (CHiP) + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
193351|NCT01590212|B1|Baseline|Mellow Bumps (MB) + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers’ understanding of neonates’ capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks’ gestation.
193352|NCT01590212|P3|Participant Flow|Care as Usual|"Care-as-usual comprises routine antenatal care provided by the NHS in line with local guidelines.~Services provided as part of an individividual woman's care plan. If indicated, a pre-birth case conference is held at 28-32 weeks."
193412|NCT01589822|O1|Outcome|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.~EVICEL Fibrin Sealant: Intraoperative (IIT)"
193353|NCT01590212|P2|Participant Flow|Chill-out in Pregnancy + Care as Usual|"Chill-out in Pregnancy is a targeted intervention aimed at pregnant women with additional health and social care needs.~It is a stress-reduction programme which includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship elements.~Groups meet every week for six weeks when the women is between 20 and 30 weeks pregnant."
193354|NCT01590212|P1|Participant Flow|Mellow Bumps + Care as Usual|"Mellow Bumps is a targeted intervention aimed at pregnant women with additional health and social care needs.~Underpinned by attachment theory, there is a focus on:~Improving maternal wellbeing by reducing stress and anxiety Increasing expectant mother's understandings of neonates' capacity for social interaction Emphasising the importance of early interaction to enhance brain development and attachment.~Groups meet every week for six weeks when the women is between 20 and 30 weeks pregnant."
193355|NCT01590212|O3|Outcome|Care as Usual|Participants received care in line with local guidelines
193356|NCT01590212|O2|Outcome|Chill-out in Pregnancy + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
193357|NCT01590212|O1|Outcome|Mellow Bumps + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation.
193358|NCT01590212|O3|Outcome|Care as Usual|Participants received care in line with local guidelines
193359|NCT01590212|O2|Outcome|Chill-out in Pregnancy + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
193360|NCT01590212|O1|Outcome|Mellow Bumps + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation.
193361|NCT01590212|O3|Outcome|Care as Usual|Participants received care in line with local guidelines
193362|NCT01590212|O2|Outcome|Chill-out in Pregnancy + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
193363|NCT01590212|O1|Outcome|Mellow Bumps + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation.
193364|NCT01590212|O3|Outcome|Care as Usual|All participants received care in line with local guidelines.
193365|NCT01590212|O2|Outcome|Chill-out in Pregnancy + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
193366|NCT01590212|O1|Outcome|Mellow Bumps + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation.
193367|NCT01590212|E3|Reported Event|Care as Usual|Participants received care in line with local guidelines
193368|NCT01590212|E2|Reported Event|Chill-out in Pregnancy + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
193369|NCT01590212|E1|Reported Event|Mellow Bumps + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation.
193370|NCT01589978|B1|Baseline|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
193413|NCT01589822|E3|Reported Event|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
193414|NCT01589822|E2|Reported Event|Standard of Care|Standard surgical technique for GI anastomosis. (Safety Set)
193415|NCT01589822|E1|Reported Event|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
193416|NCT01589653|B3|Baseline|Total|Total of all reporting groups
193510|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193371|NCT01589978|P1|Participant Flow|PROMUS Element Overall Population|"Subjects who receive the PROMUS Element everolimus-eluting coronary stent.~Subgroups within the Overall Population Group:~PLATINUM-Like Patients N=776 (at time of Primary endpoint)~Defined as: all patients without acute MI, graft stenting, CTO, ISR, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate or severe calcification by visual estimate in target lesion or target vessel proximal to target lesion, three-vessel stenting, cardiogenic shock, left main disease, or acute or chronic renal dysfunction (serum creatinine >2.0 mg/dl or patient on dialysis). For PLATINUM-like patients, lesion length and RVD should meet one of two criteria: 1) lesion length ≤28 mm and diameter ≥2.25 mm and <2.5 mm, or 2) lesion length ≤24 mm and diameter ≥2.5 mm and ≤4.25 mm.~Long Lesion Patients N=340 Defined as: patients treated with at least one 32mm or 38mm (excluding patients only treated with 2.25 mm diameter and 32 mm length WH stent size) study stent."
193372|NCT01589978|O1|Outcome|PROMUS Element Overall Population|Subjects who receive the PROMUS Element everolimus-eluting coronary stent.
193373|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
193374|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
193375|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
193376|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
193377|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
193378|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
193379|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
193380|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
193381|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
193382|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
193383|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
193384|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
193385|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
193386|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
193387|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
193388|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
193389|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
193390|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
193391|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
193392|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
193393|NCT01589978|E1|Reported Event|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
193394|NCT01589822|B4|Baseline|Total|Total of all reporting groups
193395|NCT01589822|B3|Baseline|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen~EVICEL Fibrin Sealant: Intraoperative"
193396|NCT01589822|B2|Baseline|Standard of Care|Standard surgical technique for GI anastomosis.
193397|NCT01589822|B1|Baseline|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.~EVICEL Fibrin Sealant: Intraoperative"
193398|NCT01589822|P3|Participant Flow|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen~EVICEL Fibrin Sealant: Intraoperative"
193399|NCT01589822|P2|Participant Flow|Standard of Care|Standard surgical technique for GI anastomosis.
193400|NCT01589822|P1|Participant Flow|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.~EVICEL Fibrin Sealant: Intraoperative"
193401|NCT01589822|O3|Outcome|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
193402|NCT01589822|O2|Outcome|Standard of Care|Standard surgical technique for GI anastomosis. (Safety Set)
193403|NCT01589822|O1|Outcome|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
193404|NCT01589822|O3|Outcome|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
193405|NCT01589822|O2|Outcome|Standard of Care|Standard surgical technique for GI anastomosis. (Safety Set)
193406|NCT01589822|O1|Outcome|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
193407|NCT01589822|O3|Outcome|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
193408|NCT01589822|O2|Outcome|Standard of Care|Standard surgical technique for GI anastomosis. (Safety Set)
193409|NCT01589822|O1|Outcome|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
193410|NCT01589822|O3|Outcome|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
193411|NCT01589822|O2|Outcome|Standard of Care|Standard surgical technique for GI anastomosis. (IIT)
193417|NCT01589653|B2|Baseline|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
193418|NCT01589653|B1|Baseline|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
193419|NCT01589653|P2|Participant Flow|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
193420|NCT01589653|P1|Participant Flow|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
193421|NCT01589653|O2|Outcome|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
193422|NCT01589653|O1|Outcome|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
193423|NCT01589653|O2|Outcome|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
193424|NCT01589653|O1|Outcome|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
193425|NCT01589653|O2|Outcome|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
193426|NCT01589653|O1|Outcome|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
193427|NCT01589653|O2|Outcome|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
193428|NCT01589653|O1|Outcome|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
193429|NCT01589653|O2|Outcome|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
193430|NCT01589653|O1|Outcome|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
193431|NCT01589653|E2|Reported Event|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
193432|NCT01589653|E1|Reported Event|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
193433|NCT01589601|B3|Baseline|Total|Total of all reporting groups
193434|NCT01589601|B2|Baseline|Usual Heart Failure Care|Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
193435|NCT01589601|B1|Baseline|Usual Care + Palliative Care|"Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.~Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention."
193436|NCT01589601|P2|Participant Flow|Usual Heart Failure Care|Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
193500|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
193501|NCT01589497|O3|Outcome|RHZE-RMZE|Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193502|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
193437|NCT01589601|P1|Participant Flow|Usual Care + Palliative Care|"Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.~Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention."
193438|NCT01589601|O2|Outcome|Usual Heart Failure Care|Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
193439|NCT01589601|O1|Outcome|Usual Care + Palliative Care|"Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.~Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention."
193440|NCT01589601|O2|Outcome|Usual Heart Failure Care|Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
193441|NCT01589601|O1|Outcome|Usual Care + Palliative Care|"Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.~Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention."
193442|NCT01589601|O2|Outcome|Usual Heart Failure Care|Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
193443|NCT01589601|O1|Outcome|Usual Care + Palliative Care|"Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.~Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention."
193444|NCT01589601|O2|Outcome|Usual Heart Failure Care|Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
193445|NCT01589601|O1|Outcome|Usual Care + Palliative Care|"Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.~Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention."
193503|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193504|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
193505|NCT01589497|O3|Outcome|RHZE-RMZE|Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193506|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
193446|NCT01589601|O2|Outcome|Usual Heart Failure Care|Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
193447|NCT01589601|O1|Outcome|Usual Care + Palliative Care|"Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.~Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention."
193448|NCT01589601|O2|Outcome|Usual Heart Failure Care|Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
193449|NCT01589601|O1|Outcome|Usual Care + Palliative Care|"Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.~Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention."
193450|NCT01589601|E2|Reported Event|Usual Heart Failure Care|Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
193451|NCT01589601|E1|Reported Event|Usual Care + Palliative Care|"Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.~Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention."
193452|NCT01589510|B1|Baseline|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
193453|NCT01589510|P1|Participant Flow|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
193454|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
193455|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
193456|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
193457|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
193458|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
193459|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
193460|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
193461|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
193462|NCT01589510|E1|Reported Event|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
193463|NCT01589497|B5|Baseline|Total|Total of all reporting groups
193464|NCT01589497|B4|Baseline|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
193465|NCT01589497|B3|Baseline|RHZE-RMZE|Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193466|NCT01589497|B2|Baseline|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
193467|NCT01589497|B1|Baseline|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193507|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193508|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193468|NCT01589497|P4|Participant Flow|RZE-RZE|"Participants were administered only RZE from Day 1 through Day 14. Rifampicin: Participants with body weight </= 50kg were administered one 450 mg tablet orally once daily; with body weight >50kg were administered one 600 mg tablet orally once daily.~Pyrazinamide: Participants with a body weight of 40-55 kg were administered two 500 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 500 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 500 mg tablets orally once daily.~Ethambutol: Participants with a body weight of 40-55 kg were administered two 400 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 400 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 400 mg tablets orally once daily."
193469|NCT01589497|P3|Participant Flow|RHZE-RMZE|"Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.~Rifampicin: Participants with body weight </= 50kg were administered one 450 mg tablet orally once daily; with body weight >50kg were administered one 600 mg tablet orally once daily.~Isoniazid: Participants were administered three 100 mg tablets or one 300 mg tablet once daily.~Pyrazinamide: Participants with a body weight of 40-55 kg were administered two 500 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 500 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 500 mg tablets orally once daily.~Ethambutol: Participants with a body weight of 40-55 kg were administered two 400 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 400 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 400 mg tablets orally once daily.~Moxifloxacin: one 400 mg tablet orally once a day."
193470|NCT01589497|P2|Participant Flow|RHZE-RZE|"Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.~Rifampicin: Participants with body weight </= 50kg were administered one 450 mg tablet orally once daily; with body weight >50kg were administered one 600 mg tablet orally once daily.~Isoniazid: Participants were administered three 100 mg tablets or one 300 mg tablet once daily.~Pyrazinamide: Participants with a body weight of 40-55 kg were administered two 500 mg tablets orally once daily; with body weight of 56-75 kg were administered three 500 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 500 mg tablets orally once daily.~Ethambutol: Participants with a body weight of 40-55 kg were administered two 400 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 400 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 400 mg tablets orally once"
193471|NCT01589497|P1|Participant Flow|RHZE-RHZE|"Participants were administered RHZE from Day 1 to Day 14. Rifampicin: Participants with body weight </= 50kg were administered one 450 mg tablet orally once daily; with body weight >50kg were administered one 600 mg tablet orally once daily.~Isoniazid: Participants were administered three 100 mg tablets or one 300 mg tablet once daily.~Pyrazinamide: Participants with a body weight of 40-55 kg were administered two 500 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 500 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 500 mg tablets orally once daily.~Ethambutol: Participants with a body weight of 40-55 kg were administered two 400 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 400 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 400 mg tablets orally once daily."
193472|NCT01589497|O1|Outcome|RHZE-RMZE|Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193473|NCT01589497|O1|Outcome|RHZE-RMZE|Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193474|NCT01589497|O1|Outcome|RHZE-RMZE|Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193475|NCT01589497|O1|Outcome|RHZE-RMZE|Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193476|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
193477|NCT01589497|O3|Outcome|RHZE-RMZE|Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193478|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
193479|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193480|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
193481|NCT01589497|O3|Outcome|RHZE-RMZE|Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193482|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
193483|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193484|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
193485|NCT01589497|O3|Outcome|RHZE-RMZE|Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193486|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
193487|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193488|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
193489|NCT01589497|O3|Outcome|RHZE-RMZE|Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193490|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
193491|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193492|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
193493|NCT01589497|O3|Outcome|RHZE-RMZE|Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193494|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
193495|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193496|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
193497|NCT01589497|O3|Outcome|RHZE-RMZE|Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193498|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
193499|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
194345|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
193511|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193512|NCT01589497|O3|Outcome|RHZE-RMZE|Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193513|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
193514|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193515|NCT01589497|O3|Outcome|RHZE-RMZE|Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193516|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
193517|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193518|NCT01589497|O3|Outcome|RHZE-RMZE|Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193519|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
193520|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193521|NCT01589497|O3|Outcome|RHZE-RMZE|Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193522|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
193523|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193524|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
193525|NCT01589497|O3|Outcome|RHZE-RMZE|Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193526|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
193527|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193528|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
193529|NCT01589497|O3|Outcome|RHZE-RMZE|Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193530|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
193531|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193532|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
193533|NCT01589497|O3|Outcome|RHZE-RMZE|Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193534|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
193535|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193536|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
193537|NCT01589497|O3|Outcome|RHZE-RMZE|Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193538|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
193539|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193540|NCT01589497|O1|Outcome|Overall|Qualified samples from overall participants
193541|NCT01589497|O2|Outcome|Decontaminated Processing Method|The decontaminated sputum processing method
193542|NCT01589497|O1|Outcome|Standard Processing Method|The standard sputum processing method
193543|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
193544|NCT01589497|O3|Outcome|RHZE-RMZE|Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193545|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
193546|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193547|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
193548|NCT01589497|O3|Outcome|RHZE-RMZE|Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193549|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
193550|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193551|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
193552|NCT01589497|O3|Outcome|RHZE-RMZE|Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193553|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
193554|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193555|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
193556|NCT01589497|O3|Outcome|RHZE-RMZE|Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193557|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
193558|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193559|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
193560|NCT01589497|O3|Outcome|RHZE-RMZE|Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193561|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
193562|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193563|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
193564|NCT01589497|O3|Outcome|RHZE-RMZE|Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193565|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
193566|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193567|NCT01589497|E4|Reported Event|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
193568|NCT01589497|E3|Reported Event|RHZE-RMZE|Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
193569|NCT01589497|E2|Reported Event|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
193570|NCT01589497|E1|Reported Event|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
193571|NCT01589484|B1|Baseline|Shockwave Lithotripsy (SWL)|One hundred patients fulfilled the inclusion and exclusion criteria and were enrolled in this study. Mean age and BMI were 47.1 years and 28.0 Kg/m2, respectively. Half of patients had their stone localized in the right kidney. Mean stone size was 9.1mm and mean stone density was 795 HU.
193572|NCT01589484|P1|Participant Flow|Shockwave Lithotripsy (SWL)|All patients were submitted to a noncontrast computed tomography before to shockwave lithotripsy (SWL). Patients were submitted to SWL under the following conditions: outpatient, general anesthesia, 3000 impulses, rate of 90/min, discharged from hospital in the same day with alpha-blocker (doxazosin) during 30 days.
193573|NCT01589484|O1|Outcome|SWL Complications|Shock wave lithotripsy complications
193574|NCT01589484|O1|Outcome|Primary Endoint|Shock wave lithotripsy outcome
193575|NCT01589484|E1|Reported Event|Shockwave Lithotripsy (SWL)|All patients will be submitted to a noncontrast computed tomography before to shockwave lithotripsy (SWL). Patients will be submitted to SWL under the following conditions: outpatient, general anesthesia, 3000 impulses, rate of 90/min, discharged from hospital in the same day with alpha-blocker (doxazosin) during 30 days.
193576|NCT01589445|B1|Baseline|Single Group Study With Two Interventions|"This was double blind, single group and within subjects designed study with two interventions.We screened 130 patients, selected 77 subjects who received drug Code 001, then gone through one month wash out period, then received Code 002.For PPARγ genotyping blood samples were collected from patients. There were found two groups-Pro12Pro and Pro12Ala. Baseline evaluation included detailed medical history,socioeconomic status, physical examination, and laboratory investigations for biomedical variables,psychosocial factors according to Patient Health Questionnaire (PHQ-9) and WHO-5 questionnaires.We decoded blinded drug after analyzing the results and knew that pioglitazone (30 mg once daily) was coded as 001 and metformin (850 mg once daily) as code 002.~For statistical analysis we compare Pio vs Met, Pro12Pro vs Pro12Ala, met responder vs non responder."
193577|NCT01589445|P1|Participant Flow|Single Group Study With Two Drugs- Pioglitazone and Metformin|"Group 001-Pioglitazone 30 mg tablet once daily Group 002-Metformin 850 mg tablet once daily~The single group study with a wash out period of one month with metformin 850 mg tablet once daily.~77 patients started with pioglitazone(7 drop out)and after one month wash out period 70 patients started with metformin (9 drop out).~48 patients for the 1st 3 months of pioglitazone and 32 patients for the 2nd 3 months of metformin responded to the drugs respectively according to the response rate[The treatment target was set to reduce at least ≥10% FBG or ≥1% HbA1c in the patients considering as the responder group]."
193578|NCT01589445|O2|Outcome|Metformin ( 002 Group)|Dose: Metformin tablet 850 mg once daily for 3 months
193579|NCT01589445|O1|Outcome|Pioglitazone (001 Group)|Dose: Pioglitazone tablet 30 mg once daily for 3 months
193580|NCT01589445|O2|Outcome|Metformin ( 002 Group)|Dose: Metformin tablet 850 mg once daily for 3 months
193581|NCT01589445|O1|Outcome|Pioglitazone (001 Group)|Dose: Pioglitazone tablet 30 mg once daily for 3 months
193582|NCT01589445|O2|Outcome|Metformin ( 002 Group)|Dose: Metformin tablet 850 mg once daily for 3 months
193583|NCT01589445|O1|Outcome|Pioglitazone (001 Group)|Dose: Pioglitazone tablet 30 mg once daily for 3 months
193584|NCT01589445|O2|Outcome|Metformin ( 002 Group)|Dose: Metformin tablet 850 mg once daily for 3 months
193585|NCT01589445|O1|Outcome|Pioglitazone (001 Group)|Dose: Pioglitazone tablet 30 mg once daily for 3 months
193586|NCT01589445|O2|Outcome|Metformin ( 002 Group)|Dose: Metformin tablet 850 mg once daily for 3 months
193587|NCT01589445|O1|Outcome|Pioglitazone (001 Group)|Dose: Pioglitazone tablet 30mg once daily for 3 months.
193588|NCT01589445|O2|Outcome|Metformin (002 Group)|Dose: Metformin tablet 850 mg once daily for 3 months
193589|NCT01589445|O1|Outcome|Pioglitazone (001 Group)|Dose: Pioglitazone tablet 30 mg once daily for 3 months
193590|NCT01589445|E2|Reported Event|Metformin (002 Group)|"After wash out period 70 patients started with metformin (850mg/day) for further 3 months. Adverse events were assessed non-systematically on patients' complain and also systematically in case of hypertension, weight gain, common depression (PHQ-9 method) and creatinine increase.~On basis of systemic data review and patient complain one patient was found with hypertension and another one was with increased creatinine level at the end of the metformin treatment and these events were assumed as serious adverse events as they were at health risk and withdrawn from the trial for intervention by hospital physician though they didn't need for hospitalization.~One patient complained for mild diarrhea in the first month of the metformin treatment, the patient needed necessary treatment according to doctor's advice for one day, Five patients complained for abdominal discomfort in the 1st month and antacid was provided. Six patients were assumed suffering from common depression."
193591|NCT01589445|E1|Reported Event|Pioglitazone (001 Group)|"77 patients received the drug pioglitazone (30mg/day) for 3 months. Adverse events were assessed non-systematically on patients' complain generally and also systematically in case of hypertension, weight gain, common depression [Patient Health Questionnaire (PHQ-9) method] and creatinine increase.~No serious adverse event was found during pioglitazone trial.~In case of other adverse event, one patient complained for peripheral edema which disappeared (without medicine) within 2 days at the 2nd month of the treatment, Four patients gained weight within 10% of their initial weight after 3 months of the treatment and two patients complained for abdominal discomfort in the 1st month and normal treatment with antacid was provided to them."
193592|NCT01589237|B5|Baseline|Total|Total of all reporting groups
193593|NCT01589237|B4|Baseline|Pradigastat (LCQ908) Regimen- From Study A2212|"Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
193648|NCT01588951|B1|Baseline|Arm 1|"Without LSC, standard cytarabine consolidation~Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
194346|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
193594|NCT01589237|B3|Baseline|40 mg Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
193595|NCT01589237|B2|Baseline|20 mg Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
193596|NCT01589237|B1|Baseline|Placebo of Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
193597|NCT01589237|P4|Participant Flow|Pradigastat (LCQ908) Regimen- From Study A2212|"Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
193598|NCT01589237|P3|Participant Flow|40 mg Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
193599|NCT01589237|P2|Participant Flow|20 mg Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
193600|NCT01589237|P1|Participant Flow|Placebo of Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
193601|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193602|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193603|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193604|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193605|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193606|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193607|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193710|NCT01588496|O1|Outcome|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
193608|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193609|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193610|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193611|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193612|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193613|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193614|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193615|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193616|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193617|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193618|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193619|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193620|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193621|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193622|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193623|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193624|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193625|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193626|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193649|NCT01588951|P3|Participant Flow|Arm 3|"LSC present, randomized to allogeneic transplant~Allogeneic transplant: Allogeneic stem cell transplant per institutional standards."
194347|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
193627|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193628|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193629|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193630|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193631|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193632|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193633|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193634|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193635|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193636|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193637|NCT01589237|E8|Reported Event|Part B-40 mg Pradigastat (LCQ908)|Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile.
193638|NCT01589237|E7|Reported Event|Part B- Pradigastat (LCQ908) Regimen- From Study A2212|Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile.
193639|NCT01589237|E6|Reported Event|Part B-20mg Pradigastat (LCQ908) Regimen|Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile.
193640|NCT01589237|E5|Reported Event|Part B-placebo of Pradigastat (LCQ908) Regimen|Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile.
193641|NCT01589237|E4|Reported Event|Part A: Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193642|NCT01589237|E3|Reported Event|Part A-40mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193643|NCT01589237|E2|Reported Event|Part A-20mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193644|NCT01589237|E1|Reported Event|Part A-placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
193645|NCT01588951|B4|Baseline|Total|Total of all reporting groups
193646|NCT01588951|B3|Baseline|Arm 3|"LSC present, randomized to allogeneic transplant~Allogeneic transplant: Allogeneic stem cell transplant per institutional standards."
193647|NCT01588951|B2|Baseline|Arm 2|"LSC present, randomized to cytarabine consolidation~Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
194348|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
193650|NCT01588951|P2|Participant Flow|Arm 2|"LSC present, randomized to cytarabine consolidation~Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
193651|NCT01588951|P1|Participant Flow|Arm 1|"Without LSC, standard cytarabine consolidation~Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
193652|NCT01588951|O3|Outcome|Arm 3|"LSC present, randomized to allogeneic transplant~Allogeneic transplant: Allogeneic stem cell transplant per institutional standards."
193653|NCT01588951|O2|Outcome|Arm 2|"LSC present, randomized to cytarabine consolidation~Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
193654|NCT01588951|O1|Outcome|Arm 1|"Without LSC, standard cytarabine consolidation~Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
193655|NCT01588951|E3|Reported Event|Arm 3|"LSC present, randomized to allogeneic transplant~Allogeneic transplant: Allogeneic stem cell transplant per institutional standards."
193656|NCT01588951|E2|Reported Event|Arm 2|"LSC present, randomized to cytarabine consolidation~Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
193657|NCT01588951|E1|Reported Event|Arm 1|"Without LSC, standard cytarabine consolidation~Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
193658|NCT01588821|B1|Baseline|Cabozantinib|Cabozantinib: 60 mg daily by mouth
193659|NCT01588821|P1|Participant Flow|Cabozantinib|Cabozantinib: 60 mg daily by mouth
193660|NCT01588821|O1|Outcome|Cabozantinib|Cabozantinib: 60 mg daily by mouth
193661|NCT01588821|O1|Outcome|Cabozantinib|Cabozantinib: 60 mg daily by mouth
193662|NCT01588821|E1|Reported Event|Cabozantinib|Cabozantinib: 60 mg daily by mouth
193663|NCT01588561|B1|Baseline|All Study Participants|All study participants. All participants were randomized to receive all interventions, so all participants are combined into one Arm/Group.
193664|NCT01588561|P2|Participant Flow|Nicotine First, Then Placebo|Intravenous Nicotine (1.5 mg/70 kg) first, then Placebo
193665|NCT01588561|P1|Participant Flow|Placebo First, Then Nicotine|Placebo first, then Intravenous Nicotine (1.5 mg/70 kg)
193666|NCT01588561|O2|Outcome|Placebo|Saline infusion
193667|NCT01588561|O1|Outcome|Nicotine|Intravenous Nicotine (1.5 mg/70 kg)
193668|NCT01588561|O1|Outcome|Nicotine|Intravenous Nicotine (1.5 mg/70 kg)
193669|NCT01588561|O1|Outcome|Nicotine|Intravenous Nicotine (1.5 mg/70 kg)
193670|NCT01588561|O1|Outcome|Nicotine|Intravenous Nicotine (1.5 mg/70 kg)
193671|NCT01588561|O2|Outcome|Placebo|Saline infusion
193672|NCT01588561|O1|Outcome|Nicotine|Intravenous Nicotine (1.5 mg/70 kg)
193673|NCT01588561|E2|Reported Event|Saline|Saline infusion
193674|NCT01588561|E1|Reported Event|Nicotine|Nicotine infusion
193675|NCT01588548|B7|Baseline|Total|Total of all reporting groups
193676|NCT01588548|B6|Baseline|AZD1208 800mg|Once daily continuous dosing schedule.
193677|NCT01588548|B5|Baseline|AZD1208 700mg|Once daily continuous dosing schedule.
193678|NCT01588548|B4|Baseline|AZD1208 540mg|Once daily continuous dosing schedule.
193679|NCT01588548|B3|Baseline|AZD1208 360mg|Once daily continuous dosing schedule.
193680|NCT01588548|B2|Baseline|AZD1208 240mg|Once daily continuous dosing schedule.
193681|NCT01588548|B1|Baseline|AZD1208 120mg|Once daily continuous dosing schedule.
193682|NCT01588548|P6|Participant Flow|AZD1208 800mg|Once daily continuous dosing schedule.
193683|NCT01588548|P5|Participant Flow|AZD1208 700mg|Once daily continuous dosing schedule.
193684|NCT01588548|P4|Participant Flow|AZD1208 540mg|Once daily continuous dosing schedule.
193685|NCT01588548|P3|Participant Flow|AZD1208 360mg|Once daily continuous dosing schedule.
193686|NCT01588548|P2|Participant Flow|AZD1208 240mg|Once daily continuous dosing schedule.
193687|NCT01588548|P1|Participant Flow|AZD1208 120mg|Once daily continuous dosing schedule.
193688|NCT01588548|O6|Outcome|AZD1208 800mg|Once daily continuous dosing schedule.
193689|NCT01588548|O5|Outcome|AZD1208 700mg|Once daily continuous dosing schedule.
193690|NCT01588548|O4|Outcome|AZD1208 540mg|Once daily continuous dosing schedule.
193691|NCT01588548|O3|Outcome|AZD1208 360mg|Once daily continuous dosing schedule.
193692|NCT01588548|O2|Outcome|AZD1208 240mg|Once daily continuous dosing schedule.
193693|NCT01588548|O1|Outcome|AZD1208 120mg|Once daily continuous dosing schedule.
193694|NCT01588548|E6|Reported Event|AZD1208 800mg|Once daily continuous dosing schedule.
193695|NCT01588548|E5|Reported Event|AZD1208 700mg|Once daily continuous dosing schedule.
193696|NCT01588548|E4|Reported Event|AZD1208 540mg|Once daily continuous dosing schedule.
193697|NCT01588548|E3|Reported Event|AZD1208 360mg|Once daily continuous dosing schedule.
193698|NCT01588548|E2|Reported Event|AZD1208 240mg|Once daily continuous dosing schedule.
193699|NCT01588548|E1|Reported Event|AZD1208 120mg|Once daily continuous dosing schedule.
193700|NCT01588496|B4|Baseline|Total|Total of all reporting groups
193701|NCT01588496|B3|Baseline|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
193702|NCT01588496|B2|Baseline|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
193703|NCT01588496|B1|Baseline|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
193704|NCT01588496|P3|Participant Flow|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
193705|NCT01588496|P2|Participant Flow|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
193706|NCT01588496|P1|Participant Flow|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
193707|NCT01588496|O2|Outcome|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
193708|NCT01588496|O1|Outcome|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
193709|NCT01588496|O2|Outcome|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
193711|NCT01588496|O2|Outcome|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
193712|NCT01588496|O1|Outcome|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
193713|NCT01588496|O2|Outcome|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
193714|NCT01588496|O1|Outcome|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
193715|NCT01588496|O2|Outcome|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
193716|NCT01588496|O1|Outcome|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
193717|NCT01588496|O2|Outcome|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
193718|NCT01588496|O1|Outcome|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
193719|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
193720|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
193721|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
193722|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
193723|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
193724|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
193725|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
193726|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
193727|NCT01588496|E3|Reported Event|Part B: DB Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
193728|NCT01588496|E2|Reported Event|Part B: DB Placebo|Participants received double-blind (DB) placebo subcutaneously once a month for 12 weeks.
193729|NCT01588496|E1|Reported Event|Part A: OL Evolocumab|Participants received open-label (OL) evolocumab 420 mg subcutaneously once a month for 12 weeks.
193730|NCT01588470|B1|Baseline|Pioglitazone|"Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone~pioglitazone: 45 mg per day for 6 months"
193731|NCT01588470|P1|Participant Flow|Pioglitazone|"Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone~pioglitazone : 45 mg per day for 6 months"
193732|NCT01588470|O2|Outcome|Pioglitazone|"Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone~pioglitazone: 45 mg per day for 6 months"
193733|NCT01588470|O1|Outcome|Baseline|"Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone~pioglitazone: 45 mg per day for 6 months"
193734|NCT01588470|O2|Outcome|Pioglitazone|Subjects with T2DM or non-diabetic subjects with coronary heart disease who received Pioglitazone -45 mg per day for 6 months
193735|NCT01588470|O1|Outcome|Baseline|Only subjects with T2DM or non-diabetic subjects with coronary heart disease measurement of Myocardial Glucose Uptake (MGU) at before Pioglitazone administration.
193736|NCT01588470|O2|Outcome|E to A Ratio After Pioglitazone Treatment|"Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone~pioglitazone: 45 mg per day for 6 months"
193737|NCT01588470|O1|Outcome|Baseline|"Measure of E to A Ratio to determine which subjects will receive~pioglitazone: 45 mg per day for 6 months"
193738|NCT01588470|E1|Reported Event|Pioglitazone|"Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone~pioglitazone: 45 mg per day for 6 months"
193739|NCT01588444|B3|Baseline|Total|Total of all reporting groups
193740|NCT01588444|B2|Baseline|Cortical FDBA (LifeNet)|"CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)~cortical FDBA: cortical mineralized freeze-dried bone allograft"
193741|NCT01588444|B1|Baseline|Cancellous FDBA (LifeNet)|"grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)~Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)"
193742|NCT01588444|P2|Participant Flow|Cortical FDBA (LifeNet)|"CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)~cortical FDBA: cortical mineralized freeze-dried bone allograft"
193743|NCT01588444|P1|Participant Flow|Cancellous FDBA (LifeNet)|"grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)~Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)"
193744|NCT01588444|O2|Outcome|Cortical FDBA (LifeNet)|"CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)~cortical FDBA: cortical mineralized freeze-dried bone allograft"
193745|NCT01588444|O1|Outcome|Cancellous FDBA (LifeNet)|"grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)~Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)"
193746|NCT01588444|E2|Reported Event|Cortical FDBA (LifeNet)|"CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)~cortical FDBA: cortical mineralized freeze-dried bone allograft"
193747|NCT01588444|E1|Reported Event|Cancellous FDBA (LifeNet)|"grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)~Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)"
193748|NCT01588418|B1|Baseline|PET With Exenatide vs Placebo Injection|"All subjects will receive the same intervention with Exenatide and placebo. Exenatide or placebo will be administered in random order, (i.e. first or second before OGTT-PET study).~In the first study IGT male subjects will be randomized to exenatide or placebo injection before OGTT-PET study. In the second study the same subjects will receive placebo or exenatide respectively before OGTT-PET study. The results obtained after Exenatide injection will be compared with the ones obtained after injection of placebo in the same subject."
193749|NCT01588418|P2|Participant Flow|OGTT-PET: Placebo First, Then Exenatide|In the first study subjects received placebo injected before OGTT-PET. In the second study (3 to 12 wk after first study), subjects received exenatide injection (5ug) before OGTT-PET
193750|NCT01588418|P1|Participant Flow|OGTT-PET: Exenatide First Then Placebo|In the first study subjects received exenatide 5ug injected before OGTT-PET. In the second study (3 to 12 wk after first study), subjects received placebo injection before OGTT-PET
193751|NCT01588418|O2|Outcome|Placebo First, Then Exenatide|"Placebo was injected subcutaneously 30 min before OGTT-PET study. The same subject was studied again a few weeks later with the same protocol with injection of Exenatide 5mcg .~Exenatide: Exenatide (5mcg) was administered in random order 30 min before OGTT-PET study, crossover study~Placebo: Placebo was administered in random order 30 min before OGTT-PET study in the same subject"
193752|NCT01588418|O1|Outcome|Exenatide First, Then Placebo|"Exenatide 5mcg was injected subcutaneously 30 min before Oral Glucose Tolerance Test (OGTT)-PET study. The same subject was studied again a few weeks later with the same protocol with Placebo injection.~Exenatide: Exenatide (5mcg) was administered in random order 30 min before OGTT-PET study, crossover study~Placebo: Placebo was administered in random order 30 min before OGTT-PET study in the same subject"
193753|NCT01588418|O1|Outcome|Effect of Exenatide or Placebo on CMRglu|Brain glucose metabolism (CMRglu) during OGTT measured by PET w/ or w/out Exenatide injection
193754|NCT01588418|E1|Reported Event|PET With Exenatide or Placebo Injection|This is a crossover study where all subjects received the same intervention with Exenatide and placebo, acutely in random order, (i.e. first or second before OGTT-PET study).
193755|NCT01588405|B1|Baseline|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
193756|NCT01588405|P1|Participant Flow|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
193757|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
193758|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
193759|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
193760|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
193761|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
193762|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
193763|NCT01588405|O3|Outcome|UT-15C SR (TID)|Subjects who were on TID dosing of UT-15C SR at week 24
193764|NCT01588405|O2|Outcome|UT-15C SR (BID)|Subjects who were on BID dosing of UT-15C SR at week 24
193765|NCT01588405|O1|Outcome|IV Remodulin / SQ Remodulin|Baseline while on infused Remodulin
193766|NCT01588405|O3|Outcome|UT-15C SR (TID)|Subjects who were on TID dosing of UT-15C SR at week 24
193767|NCT01588405|O2|Outcome|UT-15C SR (BID)|Subjects who were on BID dosing of UT-15C SR at week 24
193768|NCT01588405|O1|Outcome|IV Remodulin / SQ Remodulin|Baseline while on infused Remodulin
193769|NCT01588405|O3|Outcome|UT-15C SR (TID)|Subjects who were on TID dosing of UT-15C SR at week 24
193770|NCT01588405|O2|Outcome|UT-15C SR (BID)|Subjects who were on BID dosing of UT-15C SR at week 24
193771|NCT01588405|O1|Outcome|IV Remodulin / SQ Remodulin|Baseline while on infused Remodulin
193772|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
193773|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
193797|NCT01588353|O1|Outcome|Primary MP Joints|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) joints
194349|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
193774|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
193775|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
193776|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
193777|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
193778|NCT01588405|E1|Reported Event|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
193779|NCT01588353|B4|Baseline|Total|Total of all reporting groups
193780|NCT01588353|B3|Baseline|AK160 0.58 mg Step3|"The participants in step 3 were added until the number of injected joints by joint type became up to 50 or more in steps1 through 3.~This arm was mainly used to determine the safety of the drug with participants enrolled in steps 1 and 2.~Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
193781|NCT01588353|B2|Baseline|AK160 0.58 mg Step 2|"This arm consisting of participants enrolled in step 2 was used to determine the efficacy of the drug with participants enrolled in step 1 and to determine the safety with participants enrolled in steps 1 and 3.~Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
193782|NCT01588353|B1|Baseline|AK160 0.58 mg Step 1|"This arm consisting of participants enrolled in step 1 was used to confirm the efficacy and satety of the drug 30 days after the first dose before starting step 2.~And also this arm was used to determine the efficacy of the drug with participants enrolled in step 2 and to determine the safety with participants enrolled in steps 2 and 3.~Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
193783|NCT01588353|P3|Participant Flow|AK160 0.58 mg Step3|"The participants in step 3 were added until the number of injected joints by joint type became up to 50 or more in steps1 through 3.~This arm was mainly used to determine the safety of the drug with participants enrolled in steps 1 and 2.~Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
193784|NCT01588353|P2|Participant Flow|AK160 0.58 mg Step 2|"This arm consisting of participants enrolled in step 2 was used to determine the efficacy of the drug with participants enrolled in step 1 and to determine the safety with participants enrolled in steps 1 and 3.~Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
193785|NCT01588353|P1|Participant Flow|AK160 0.58 mg Step1|"This arm consisting of participants enrolled in step 1 was used to confirm the efficacy and satety of the drug 30 days after the first dose before starting step 2.~And also this arm was used to determine the efficacy of the drug with participants enrolled in step 2 and to determine the safety with participants enrolled in steps 2 and 3.~Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
193786|NCT01588353|O3|Outcome|Total|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) or proximal interphalangeal (PIP) joints
193787|NCT01588353|O2|Outcome|Primary PIP Joints|collagenase clostridium histolyticum 0.58mg injected into proximal interphalangeal (PIP) joints
193788|NCT01588353|O1|Outcome|Primary MP Joints|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) joints
193789|NCT01588353|O3|Outcome|Total|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) or proximal interphalangeal (PIP) joints
193790|NCT01588353|O2|Outcome|Primary PIP Joints|collagenase clostridium histolyticum 0.58mg injected into proximal interphalangeal (PIP) joints
193791|NCT01588353|O1|Outcome|Primary MP Joints|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) joints
193792|NCT01588353|O3|Outcome|Total|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) or proximal interphalangeal (PIP) joints
193793|NCT01588353|O2|Outcome|Primary PIP Joints|collagenase clostridium histolyticum 0.58mg injected into proximal interphalangeal (PIP) joints
193794|NCT01588353|O1|Outcome|Primary MP Joints|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) joints
193795|NCT01588353|O3|Outcome|Total|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) or proximal interphalangeal (PIP) joints
193796|NCT01588353|O2|Outcome|Primary PIP Joints|collagenase clostridium histolyticum 0.58mg injected into proximal interphalangeal (PIP) joints
193798|NCT01588353|O1|Outcome|AK160 0.58 mg Step 1-2|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
193799|NCT01588353|E1|Reported Event|AK160 0.58 mg Step 1-3|Collagenase Clostridium Histolyticum: AK160 (Collagenase Clostridium Histolyticum) 0.58 mg
193800|NCT01588158|B3|Baseline|Total|Total of all reporting groups
193801|NCT01588158|B2|Baseline|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
193802|NCT01588158|B1|Baseline|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
193803|NCT01588158|P2|Participant Flow|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
193804|NCT01588158|P1|Participant Flow|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
193805|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
193806|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
193807|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
193808|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
193809|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
193810|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
193811|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
193812|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
193813|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
193814|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
193815|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
193816|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
193817|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
193818|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
193819|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
193820|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
193821|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
193822|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
193823|NCT01588158|E2|Reported Event|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
193824|NCT01588158|E1|Reported Event|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
193825|NCT01588106|B3|Baseline|Total|Total of all reporting groups
193826|NCT01588106|B2|Baseline|Control Group- Standard CONTOUR|Subjects used the standard CONTOUR device. Subjects’ blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline.
193827|NCT01588106|B1|Baseline|Test Group- CONTOUR Next USB|Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects’ blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline.
193828|NCT01588106|P2|Participant Flow|Control Group- Standard CONTOUR|Subjects used the standard CONTOUR device. Subjects’ blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline.
193829|NCT01588106|P1|Participant Flow|Test Group- CONTOUR Next USB|Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects’ blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline.
193830|NCT01588106|O2|Outcome|Control Group- Standard CONTOUR|Subjects used the standard CONTOUR device. Subjects’ blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline.
193831|NCT01588106|O1|Outcome|Test Group- CONTOUR Next USB|Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects’ blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline.
193832|NCT01588106|E2|Reported Event|Control Group- Standard CONTOUR|Subjects used the standard CONTOUR device. Subjects’ blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline.
193833|NCT01588106|E1|Reported Event|Test Group- CONTOUR Next USB|Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects’ blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline.
193834|NCT01587989|B3|Baseline|Total|Total of all reporting groups
193872|NCT01587950|O8|Outcome|5% KNO3 Solution (10 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
193873|NCT01587950|O7|Outcome|2.5% KNO3 Solution (10 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
194350|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
193835|NCT01587989|B2|Baseline|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
193836|NCT01587989|B1|Baseline|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
193837|NCT01587989|P3|Participant Flow|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
193838|NCT01587989|P2|Participant Flow|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
193839|NCT01587989|P1|Participant Flow|All Participants|Participants received TCZ 8 milligrams per kilogram (mg/kg), intravenously (IV), every 4 weeks, from Weeks 1-12. Participants also received MTX 15 milligrams per week (mg/week) to 25 mg/week at a stable dose, orally (PO) as tablets, once per week, from Weeks 1-12. Participants also received folic acid, greater than or equal to (≥) 5 mg/week, PO, from Weeks 1-12. Participants also received non-sterioidal anti-inflammatory drugs (NSAIDs) and oral corticosteroids (less than or equal to [≤] 10 milligrams per day [mg/day] prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-12. At Week 12 participants who had achieved a good or moderate European League Against Rheumatism (EULAR) response were randomized to receive TCZ plus (+) continued MTX treatment or TCZ + placebo. Participants without a good or moderate EULAR response were excluded from the study and treated according to the standard of care of the treatment site.
193840|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
193841|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
193842|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
193843|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
193874|NCT01587950|O6|Outcome|Sterile Water (5 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 5 minutes during each treatment period.
193875|NCT01587950|O5|Outcome|5% KNO3 Solution (5 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
194351|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
193844|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
193845|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
193846|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
193847|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
193848|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
193849|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
193850|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
193851|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
193852|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
193853|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
193854|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
193855|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
193856|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
193857|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
193858|NCT01587989|E2|Reported Event|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
193859|NCT01587989|E1|Reported Event|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
193860|NCT01587963|B3|Baseline|Total|Total of all reporting groups
193861|NCT01587963|B2|Baseline|Ringers Lactate or Normal Saline|"Ringers Lactate or Normal Saline~Ringers Lactate or Normal Saline: Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour."
193862|NCT01587963|B1|Baseline|Ascorbic Acid|"Ascorbic Acid~Ascorbic Acid: 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams"
193863|NCT01587963|P2|Participant Flow|Placebo|"Ringers Lactate or Normal Saline~Ringers Lactate or Normal Saline: Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour."
193864|NCT01587963|P1|Participant Flow|Ascorbic Acid|"Ascorbic Acid~Ascorbic Acid: 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams"
193865|NCT01587963|O2|Outcome|Ringers Lactate or Normal Saline|"Ringers Lactate or Normal Saline~Ringers Lactate or Normal Saline: Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour."
193866|NCT01587963|O1|Outcome|Ascorbic Acid|"Ascorbic Acid~Ascorbic Acid: 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams"
193867|NCT01587963|E2|Reported Event|Ringers Lactate or Normal Saline|"Ringers Lactate or Normal Saline~Ringers Lactate or Normal Saline: Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour."
193868|NCT01587963|E1|Reported Event|Ascorbic Acid|"Ascorbic Acid~Ascorbic Acid: 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams"
193869|NCT01587950|B1|Baseline|Overall|All randomized participants received all study treatments during this cross over study design.
193870|NCT01587950|P1|Participant Flow|Overall|There were six study treatment regimens- 5% Potassium nitrate (KNO3) 250μl applied to an individual tooth once for 2, 5 or 10 min; 2.5% KNO3 (250μl) applied to an individual tooth once for 2, 5 or 10 mins. Three reference treatment regimens were sterile water (250μl) applied to an individual tooth once for 2, 5 or 10 mins. Each participant received 9 treatment regimens over three treatment visits. Three individual teeth were treated at each treatment visit. Each treatment visit was one day in length. A washout of 4 days was given after each treatment visit. Study duration for each participant during this efficacy analysis phase was approximately 5 weeks
193871|NCT01587950|O9|Outcome|Sterile Water (10 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 10 minutes during each treatment period.
194352|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
193876|NCT01587950|O4|Outcome|2.5% KNO3 Solution (5 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
193877|NCT01587950|O3|Outcome|Sterile Water (2 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 2 minutes during each treatment period.
193878|NCT01587950|O2|Outcome|5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
193879|NCT01587950|O1|Outcome|2.5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
193880|NCT01587950|O9|Outcome|Sterile Water (10 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 10 minutes during each treatment period.
193881|NCT01587950|O8|Outcome|5% KNO3 Solution (10 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
193882|NCT01587950|O7|Outcome|2.5% KNO3 Solution (10 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
193883|NCT01587950|O6|Outcome|Sterile Water (5 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 5 minutes during each treatment period.
193884|NCT01587950|O5|Outcome|5% KNO3 Solution (5 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
193885|NCT01587950|O4|Outcome|2.5% KNO3 Solution (5 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
193886|NCT01587950|O3|Outcome|Sterile Water (2 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 2 minutes during each treatment period.
193887|NCT01587950|O2|Outcome|5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth sensitive tooth once for 2 minutes during each treatment period.
193888|NCT01587950|O1|Outcome|2.5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
193889|NCT01587950|O9|Outcome|Sterile Water (10 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 10 minutes during each treatment period.
193890|NCT01587950|O8|Outcome|5% KNO3 Solution (10 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
193891|NCT01587950|O7|Outcome|2.5% KNO3 Solution (10 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
193892|NCT01587950|O6|Outcome|Sterile Water (5 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 5 minutes during each treatment period.
193893|NCT01587950|O5|Outcome|5% KNO3 Solution (5 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
193894|NCT01587950|O4|Outcome|2.5% KNO3 Solution (5 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
193895|NCT01587950|O3|Outcome|Sterile Water (2 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 2 minutes during each treatment period.
193896|NCT01587950|O2|Outcome|5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
193897|NCT01587950|O1|Outcome|2.5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
193898|NCT01587950|E1|Reported Event|Overall|All participants received all study treatments during this cross over study design.
193899|NCT01587924|B5|Baseline|Total|Total of all reporting groups
193900|NCT01587924|B4|Baseline|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
193901|NCT01587924|B3|Baseline|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
193902|NCT01587924|B2|Baseline|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
193903|NCT01587924|B1|Baseline|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 mg once daily for 4 weeks and we re followed-up for 2 weeks
193904|NCT01587924|P4|Participant Flow|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
193905|NCT01587924|P3|Participant Flow|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
193906|NCT01587924|P2|Participant Flow|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
193907|NCT01587924|P1|Participant Flow|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 milligrams (mg) once daily for 4 weeks and we re followed-up for 2 weeks
193908|NCT01587924|O4|Outcome|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
193909|NCT01587924|O3|Outcome|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
193910|NCT01587924|O2|Outcome|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
193911|NCT01587924|O1|Outcome|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 mg once daily for 4 weeks and we re followed-up for 2 weeks
193912|NCT01587924|O4|Outcome|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
193913|NCT01587924|O3|Outcome|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
193914|NCT01587924|O2|Outcome|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
193915|NCT01587924|O1|Outcome|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 mg once daily for 4 weeks and we re followed-up for 2 weeks
193916|NCT01587924|O4|Outcome|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
193917|NCT01587924|O3|Outcome|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
193918|NCT01587924|O2|Outcome|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
193919|NCT01587924|O1|Outcome|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 mg once daily for 4 weeks and we re followed-up for 2 weeks
193920|NCT01587924|O3|Outcome|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
193921|NCT01587924|O2|Outcome|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
193922|NCT01587924|O1|Outcome|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 mg once daily for 4 weeks and we re followed-up for 2 weeks
193923|NCT01587924|O4|Outcome|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
193924|NCT01587924|O3|Outcome|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
193925|NCT01587924|O2|Outcome|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
193926|NCT01587924|O1|Outcome|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 mg once daily for 4 weeks and we re followed-up for 2 weeks
193927|NCT01587924|O4|Outcome|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
193928|NCT01587924|O3|Outcome|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
193929|NCT01587924|O2|Outcome|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
193930|NCT01587924|O1|Outcome|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 mg once daily for 4 weeks and we re followed-up for 2 weeks
193931|NCT01587924|O4|Outcome|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
193932|NCT01587924|O3|Outcome|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
193933|NCT01587924|O2|Outcome|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
193934|NCT01587924|O1|Outcome|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 mg once daily for 4 weeks and we re followed-up for 2 weeks
193935|NCT01587924|O4|Outcome|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
193936|NCT01587924|O3|Outcome|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
193937|NCT01587924|O2|Outcome|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
193938|NCT01587924|O1|Outcome|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 mg once daily for 4 weeks and we re followed-up for 2 weeks
193939|NCT01587924|O4|Outcome|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
193940|NCT01587924|O3|Outcome|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
193941|NCT01587924|O2|Outcome|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
193942|NCT01587924|O1|Outcome|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 mg once daily for 4 weeks and we re followed-up for 2 weeks
193943|NCT01587924|O4|Outcome|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
193944|NCT01587924|O3|Outcome|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
193945|NCT01587924|O2|Outcome|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
193946|NCT01587924|O1|Outcome|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 mg once daily for 4 weeks and we re followed-up for 2 weeks
193947|NCT01587924|O4|Outcome|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
193948|NCT01587924|O3|Outcome|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
193949|NCT01587924|O2|Outcome|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
193950|NCT01587924|O1|Outcome|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 mg once daily for 4 weeks and we re followed-up for 2 weeks
193951|NCT01587924|O4|Outcome|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
193952|NCT01587924|O3|Outcome|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
193953|NCT01587924|O2|Outcome|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
193954|NCT01587924|O1|Outcome|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 mg once daily for 4 weeks and we re followed-up for 2 weeks
193955|NCT01587924|O4|Outcome|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
193956|NCT01587924|O3|Outcome|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
193957|NCT01587924|O2|Outcome|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
193958|NCT01587924|O1|Outcome|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 mg once daily for 4 weeks and we re followed-up for 2 weeks
193959|NCT01587924|O4|Outcome|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
193960|NCT01587924|O3|Outcome|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
193961|NCT01587924|O2|Outcome|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
193962|NCT01587924|O1|Outcome|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 mg once daily for 4 weeks and we re followed-up for 2 weeks
193963|NCT01587924|O4|Outcome|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
193964|NCT01587924|O3|Outcome|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
193965|NCT01587924|O2|Outcome|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
193966|NCT01587924|O1|Outcome|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 mg once daily for 4 weeks and we re followed-up for 2 weeks
193967|NCT01587924|O4|Outcome|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
193968|NCT01587924|O3|Outcome|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
193969|NCT01587924|O2|Outcome|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
193970|NCT01587924|O1|Outcome|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 mg once daily for 4 weeks and we re followed-up for 2 weeks
193971|NCT01587924|O4|Outcome|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
193972|NCT01587924|O3|Outcome|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
193973|NCT01587924|O2|Outcome|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
193974|NCT01587924|O1|Outcome|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 mg once daily for 4 weeks and we re followed-up for 2 weeks
193975|NCT01587924|O4|Outcome|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
193976|NCT01587924|O3|Outcome|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
193977|NCT01587924|O2|Outcome|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
193978|NCT01587924|O1|Outcome|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 mg once daily for 4 weeks and we re followed-up for 2 weeks
193979|NCT01587924|O4|Outcome|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
193980|NCT01587924|O3|Outcome|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
193981|NCT01587924|O2|Outcome|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
193982|NCT01587924|O1|Outcome|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 mg once daily for 4 weeks and we re followed-up for 2 weeks
193983|NCT01587924|O4|Outcome|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
193984|NCT01587924|O3|Outcome|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
193985|NCT01587924|O2|Outcome|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
193986|NCT01587924|O1|Outcome|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 mg once daily for 4 weeks and we re followed-up for 2 weeks
193987|NCT01587924|O4|Outcome|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
193988|NCT01587924|O3|Outcome|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
193989|NCT01587924|O2|Outcome|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
193990|NCT01587924|O1|Outcome|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 mg once daily for 4 weeks and we re followed-up for 2 weeks
193991|NCT01587924|O4|Outcome|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
193992|NCT01587924|O3|Outcome|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
193993|NCT01587924|O2|Outcome|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
193994|NCT01587924|O1|Outcome|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 mg once daily for 4 weeks and we re followed-up for 2 weeks
193995|NCT01587924|O4|Outcome|rhEPO|Eligible participants received oral rhEPO or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
193996|NCT01587924|O3|Outcome|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
193997|NCT01587924|O2|Outcome|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
193998|NCT01587924|O1|Outcome|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 mg once daily for 4 weeks and we re followed-up for 2 weeks
193999|NCT01587924|E4|Reported Event|rhEPO|Eligible participants received oral recombinant human erythropoietin (rhEPO ) or darbepoetin once daily for 4 weeks and were followed-up for 2 weeks
194000|NCT01587924|E3|Reported Event|5 mg GSK1278863|Eligible participants received oral GK1278863 5.0 mg once daily for 4 weeks and were followed-up for 2 weeks.
194001|NCT01587924|E2|Reported Event|2 mg GSK1278863|Eligible participants received oral GK1278863 2.0 mg once daily for 4 weeks and were followed-up for 2 weeks
194002|NCT01587924|E1|Reported Event|0.5 mg GSK1278863|Eligible participants received oral GK1278863 0.5 milligrams (mg) once daily for 4 weeks and we re followed-up for 2 weeks
194003|NCT01587898|B5|Baseline|Total|Total of all reporting groups
194004|NCT01587898|B4|Baseline|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194005|NCT01587898|B3|Baseline|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194006|NCT01587898|B2|Baseline|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194007|NCT01587898|B1|Baseline|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194008|NCT01587898|P4|Participant Flow|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194009|NCT01587898|P3|Participant Flow|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194010|NCT01587898|P2|Participant Flow|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 milligram (mg) tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194011|NCT01587898|P1|Participant Flow|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194012|NCT01587898|O3|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194013|NCT01587898|O2|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194014|NCT01587898|O1|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194015|NCT01587898|O3|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194016|NCT01587898|O2|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194017|NCT01587898|O1|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194018|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194019|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194020|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194021|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194022|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194198|NCT01587885|E2|Reported Event|Omeprazole 20 mg|Participants will receive omeprazole 20 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
194023|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194024|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194025|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194026|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194027|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194028|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194029|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194030|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194031|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194032|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194033|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194034|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194035|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194036|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194037|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194038|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194039|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194040|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194041|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194042|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194043|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194285|NCT01587079|O5|Outcome|GFF MDI 2.4/9.6 μg BID|2.4/9.6 μg BID
194044|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194045|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194046|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194047|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194048|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194049|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194050|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194051|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194052|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194053|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194054|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194055|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194056|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194057|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194058|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194059|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194060|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194061|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194062|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194063|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194064|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194286|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
194065|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194066|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194067|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194068|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194069|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194070|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194071|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194072|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194073|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194074|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194075|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194076|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194077|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194078|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194079|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194080|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194081|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194082|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194083|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194084|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194085|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194287|NCT01587079|O3|Outcome|GFF/MDI 9/9.6 μg BID|9/9.6 μg BID
194086|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194087|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194088|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194089|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194090|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194091|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194092|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194093|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194094|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194095|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194096|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194097|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194098|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194099|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194100|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194101|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194102|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194103|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194104|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194105|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194106|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194288|NCT01587079|O2|Outcome|GFF MDI 18/9.6 μg BID|18/9.6 μg BID
194107|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194108|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194109|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194110|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194111|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194112|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194113|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194114|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194115|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194116|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194117|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194118|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194119|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194120|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194121|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194122|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194123|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194124|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194125|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194126|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194127|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194289|NCT01587079|O1|Outcome|GP MDI 18 μg BID|18 μg BID
194128|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194129|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194130|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194131|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194132|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194133|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194134|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194135|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194136|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194137|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194138|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194139|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194140|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194141|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194142|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194143|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194144|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194145|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194146|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194147|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194148|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194290|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
194149|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194150|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194151|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194152|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194153|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194154|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194155|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194156|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194157|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194158|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194159|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194160|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194161|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194162|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194163|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194164|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194165|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194166|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194167|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194168|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194169|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194291|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
194170|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194171|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194172|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194173|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194174|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194175|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194176|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194177|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194178|NCT01587898|O4|Outcome|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194179|NCT01587898|O3|Outcome|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194180|NCT01587898|O2|Outcome|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194181|NCT01587898|O1|Outcome|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194182|NCT01587898|E4|Reported Event|GSK1278863, 5 mg|Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194183|NCT01587898|E3|Reported Event|GSK1278863, 2 mg|Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194184|NCT01587898|E2|Reported Event|GSK1278863, 0.5 mg|Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194185|NCT01587898|E1|Reported Event|Placebo|Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit.
194186|NCT01587885|B1|Baseline|All Participants|All participants who were randomized and received study drug.
194187|NCT01587885|P2|Participant Flow|Omeprazole 20mg Then Omeprazole 20mg+Sodium Bicarbonate 1100mg|Participants will receive omeprazole 20 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
194188|NCT01587885|P1|Participant Flow|Omeprazole 20mg+Sodium Bicarbonate 1100mg Then Omeprazole 20mg|Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg once a day for 4 days.
194189|NCT01587885|O2|Outcome|Omeprazole 20 mg|Participants will receive omeprazole 20 mg once a day for 4 days.
194190|NCT01587885|O1|Outcome|Omeprazole 20 mg + Sodium Bicarbonate 1100 mg|Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
194191|NCT01587885|O1|Outcome|All Treated Participants|
194192|NCT01587885|O1|Outcome|All Treated Participants|
194193|NCT01587885|O1|Outcome|All Treated Participants|
194194|NCT01587885|O2|Outcome|Omeprazole 20 mg|Participants will receive omeprazole 20 mg once a day for 4 days.
194195|NCT01587885|O1|Outcome|Omeprazole 20 mg + Sodium Bicarbonate 1100 mg|Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
194196|NCT01587885|O2|Outcome|Omeprazole 20 mg|Participants will receive omeprazole 20 mg once a day for 4 days.
194197|NCT01587885|O1|Outcome|Omeprazole 20 mg + Sodium Bicarbonate 1100 mg|Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
194199|NCT01587885|E1|Reported Event|Omeprazole 20 mg + Sodium Bicarbonate 1100 mg|Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg once a day for 4 days.
194200|NCT01587651|B4|Baseline|Total|Total of all reporting groups
194201|NCT01587651|B3|Baseline|Ticagrelor Maintenance Dose|"Ticagrelor 90 mg twice-daily (BID) MD~Ticagrelor Maintenance Dose : one 90mg film coated tablet"
194202|NCT01587651|B2|Baseline|Prasugrel Maintenance Dose|"Prasugrel 10 mg QD MD~Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet"
194203|NCT01587651|B1|Baseline|Prasugrel Loading Dose|"Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)~Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet~Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets"
194204|NCT01587651|P3|Participant Flow|Ticagrelor Maintenance Dose|"Ticagrelor 90 mg twice-daily (BID) MD~Ticagrelor Maintenance Dose : one 90mg film coated tablet"
194205|NCT01587651|P2|Participant Flow|Prasugrel Maintenance Dose|"Prasugrel 10 mg QD MD~Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet"
194206|NCT01587651|P1|Participant Flow|Prasugrel Loading Dose|"Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)~Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet~Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets"
194207|NCT01587651|O4|Outcome|Prasugrel Maintenance Dose|prasugrel 10 mg QD for 7 days
194208|NCT01587651|O3|Outcome|Prasugrel Loading Dose|prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
194209|NCT01587651|O2|Outcome|Ticagrelor|
194210|NCT01587651|O1|Outcome|Prasugrel Combined Groups|combined Prasugrel loading dose and Prasugrel maintenance dose
194211|NCT01587651|O4|Outcome|Prasugrel Maintenance Dose|prasugrel 10 mg QD for 7 days
194212|NCT01587651|O3|Outcome|Prasugrel Loading Dose|prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
194213|NCT01587651|O2|Outcome|Ticagrelor|
194214|NCT01587651|O1|Outcome|Prasugrel Combined Groups|combined Prasugrel loading dose and Prasugrel maintenance dose
194215|NCT01587651|O4|Outcome|Prasugrel Maintenance Dose|prasugrel 10 mg QD for 7 days
194216|NCT01587651|O3|Outcome|Prasugrel Loading Dose|prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
194217|NCT01587651|O2|Outcome|Ticagrelor|
194218|NCT01587651|O1|Outcome|Prasugrel Combined Groups|combined Prasugrel loading dose and Prasugrel maintenance dose
194219|NCT01587651|O4|Outcome|Prasugrel Maintenance Dose|prasugrel 10 mg QD for 7 days
194220|NCT01587651|O3|Outcome|Prasugrel Loading Dose|prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
194221|NCT01587651|O2|Outcome|Ticagrelor|
194222|NCT01587651|O1|Outcome|Prasugrel Combined Groups|combined Prasugrel loading dose and Prasugrel maintenance dose
194223|NCT01587651|O4|Outcome|Prasugrel Maintenance Dose|prasugrel 10 mg QD for 7 days
194224|NCT01587651|O3|Outcome|Prasugrel Loading Dose|prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
194225|NCT01587651|O2|Outcome|Ticagrelor|
194226|NCT01587651|O1|Outcome|Prasugrel Combined Groups|combined Prasugrel loading dose and Prasugrel maintenance dose
194227|NCT01587651|O2|Outcome|Ticagrelor|
194228|NCT01587651|O1|Outcome|Prasugrel Combined Groups|combined Prasugrel loading dose and Prasugrel maintenance dose
194229|NCT01587651|E3|Reported Event|Ticagrelor Maintenance Dose|"Ticagrelor 90 mg twice-daily (BID) MD~Ticagrelor Maintenance Dose : one 90mg film coated tablet"
194230|NCT01587651|E2|Reported Event|Prasugrel Maintenance Dose|"Prasugrel 10 mg QD MD~Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet"
194231|NCT01587651|E1|Reported Event|Prasugrel Loading Dose|"Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)~Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet~Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets"
194232|NCT01587118|B1|Baseline|Antidepressant Plus Asenapine|"adjunctive asenapine~Adjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks."
194233|NCT01587118|P1|Participant Flow|Antidepressant Plus Asenapine|"adjunctive asenapine~Adjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks."
194234|NCT01587118|O1|Outcome|Antidepressant Plus Asenapine|"adjunctive asenapine~Adjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks."
194235|NCT01587118|O1|Outcome|Antidepressant Plus Asenapine|"adjunctive asenapine~Adjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks."
194236|NCT01587118|E1|Reported Event|Antidepressant Plus Asenapine|"adjunctive asenapine~Adjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks."
194237|NCT01587105|B3|Baseline|Total|Total of all reporting groups
194238|NCT01587105|B2|Baseline|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital~Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
194239|NCT01587105|B1|Baseline|Control|Usual Care Group
194292|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
194293|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
194294|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
194240|NCT01587105|P2|Participant Flow|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital~Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
194241|NCT01587105|P1|Participant Flow|Control|Usual Care Group
194242|NCT01587105|O2|Outcome|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital~Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
194243|NCT01587105|O1|Outcome|Control|Usual Care Group
194244|NCT01587105|O2|Outcome|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital~Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
194245|NCT01587105|O1|Outcome|Control|Usual Care Group
194246|NCT01587105|O2|Outcome|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital~Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
194247|NCT01587105|O1|Outcome|Control|Usual Care Group
194248|NCT01587105|O2|Outcome|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital~Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
194249|NCT01587105|O1|Outcome|Control|Usual Care Group
194250|NCT01587105|O2|Outcome|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital~Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
194251|NCT01587105|O1|Outcome|Control|Usual Care Group
194252|NCT01587105|O2|Outcome|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital~Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
194253|NCT01587105|O1|Outcome|Control|Usual Care Group
194254|NCT01587105|E2|Reported Event|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital~Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
194255|NCT01587105|E1|Reported Event|Control|Usual Care Group
194256|NCT01587079|B1|Baseline|All Subjects Screened|
194257|NCT01587079|P1|Participant Flow|All Subjects|
194258|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
194259|NCT01587079|O7|Outcome|FF MDI 9.6 μg BID|9.6 μg BID
194260|NCT01587079|O6|Outcome|GFF MDI 1.2/9.6 μg BID|1.2/9.6 μg BID
194261|NCT01587079|O5|Outcome|GFF MDI 2.4/9.6 μg BID|2.4/9.6 μg BID
194262|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg BID|4.6/9.6 μg BID
194263|NCT01587079|O3|Outcome|GFF/MDI 9/9.6 μg BID|9/9.6 μg BID
194264|NCT01587079|O2|Outcome|GFF MDI 18/9.6 μg BID|18/9.6 μg BID
194265|NCT01587079|O1|Outcome|GP MDI 18 μg BID|18 μg BID
194266|NCT01587079|O8|Outcome|Spiriva18 μg QD|18 μg QD
194267|NCT01587079|O7|Outcome|FF MDI 9.6 μg BID|9.6 μg BID
194268|NCT01587079|O6|Outcome|GFF MDI 1.2/9.6 μg BID|1.2/9.6 μg BID
194269|NCT01587079|O5|Outcome|GFF MDI 2.4/9.6 μg BID|2.4/9.6 μg BID
194270|NCT01587079|O4|Outcome|GFF MDI 4.6/9.6 μg BID|4.6/9.6 μg BID
194271|NCT01587079|O3|Outcome|GFF/MDI 9/9.6 μg BID|9/9.6 μg BID
194272|NCT01587079|O2|Outcome|GFF MDI 18/9.6 μg BID|18/9.6 μg BID
194273|NCT01587079|O1|Outcome|GP MDI 18 μg BID|18 μg BID
194274|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
194275|NCT01587079|O7|Outcome|FF MDI 9.6 μg BID|9.6 μg BID
194276|NCT01587079|O6|Outcome|GFF MDI 1.2/9.6 μg BID|1.2/9.6 μg BID
194277|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
194278|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
194279|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
194280|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
194281|NCT01587079|O1|Outcome|GP MDI 18 μg BID|18 μg BID
194282|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
194283|NCT01587079|O7|Outcome|FF MDI 9.6 μg BID|9.6 μg BID
194284|NCT01587079|O6|Outcome|GFF MDI 1.2/9.6 μg BID|1.2/9.6 μg BID
194353|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
194354|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
194355|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
194356|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
194357|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
194358|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
194359|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
194360|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
194361|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
194362|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
194363|NCT01587079|O7|Outcome|FF MDI 9.6 μg|9.6 μg
194364|NCT01587079|O6|Outcome|GFF MDI 1.2/9.6 μg (PT003)|1.2/9.6 μg
194365|NCT01587079|O5|Outcome|GFF MDI 2.4/9.6 μg (PT003)|2.4/9.6 μg
194366|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
194367|NCT01587079|O3|Outcome|GFF/MDI 9/9.6 μg|9/9.6 μg
194368|NCT01587079|O2|Outcome|GFF MDI 18/9.6 μg (PT003)|18/9.6 μg
194369|NCT01587079|O1|Outcome|GP MDI 18 μg (PT001)|18 μg
194370|NCT01587079|E8|Reported Event|Spiriva|18 μg
194371|NCT01587079|E7|Reported Event|FF MDI 9.6 μg (PT005)|9.6 μg
194372|NCT01587079|E6|Reported Event|GFF MDI 1.2/9.6 μg (PT003)|1.2/9.6 μg
194373|NCT01587079|E5|Reported Event|GFF MDI 2.4/9.6 μg (PT003)|2.4/9.6 μg
194374|NCT01587079|E4|Reported Event|GFF MDI 4.6/9.6 μg (PT003)|4.6/9.6 μg
194375|NCT01587079|E3|Reported Event|GFF MDI 9/9.6 μg (PT003)|9/9.6 μg
194376|NCT01587079|E2|Reported Event|GFF MDI 18/9.6 μg (PT003)|18/9.6 μg
194377|NCT01587079|E1|Reported Event|GP MDI 18 μg (PT001)|18 μg
194378|NCT01587027|B3|Baseline|Total|Total of all reporting groups
194379|NCT01587027|B2|Baseline|Sequence B|"Treatment 2, Treatment 1, Treatment 3~Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally~Treatment 2 : Methazolamide dosage form-tablet dosage-250mg"
194380|NCT01587027|B1|Baseline|Sequence A|"Treatment 1, Treatment 2, Treatment 3~Treatment 1 : Aminophylline dosage form-tablet dosage-500mg~Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally"
194381|NCT01587027|P2|Participant Flow|Sequence B|"Treatment 2, Treatment 1, Treatment 3~Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally~Treatment 2 : Methazolamide dosage form-tablet dosage-250mg"
194382|NCT01587027|P1|Participant Flow|Sequence A|"Treatment 1, Treatment 2, Treatment 3~Treatment 1 : Aminophylline dosage form-tablet dosage-500mg~Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally"
194383|NCT01587027|O2|Outcome|Sequence B|"Treatment 2, Treatment 1, Treatment 3~Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally~Treatment 2 : Methazolamide dosage form-tablet dosage-250mg"
194384|NCT01587027|O1|Outcome|Sequence A|"Treatment 1, Treatment 2, Treatment 3~Treatment 1 : Aminophylline dosage form-tablet dosage-500mg~Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally"
194385|NCT01587027|E2|Reported Event|Arm B|Methazolamide (1 Day) Washout (1 Day) Aminophylline (1 Day) Washout (1 Day) Both Aminophylline & Methazolamide (1 Day) Discharge (1 Day)
194386|NCT01587027|E1|Reported Event|Arm A|Aminophylline (1 Day) Washout (1 Day) Methazolamide (1 Day) Washout (1 Day) Both Aminophylline & Methazolamide (1 Day) Discharge (1 Day)
194387|NCT01587014|B1|Baseline|Device Arm|ICU patients receive the Prima-Temp Temperature Monitoring Patch.
194388|NCT01587014|P1|Participant Flow|Prima-Temp Monitoring Patch|ICU patients receive the Prima-Temp Temperature Monitoring Patch.
194389|NCT01587014|O1|Outcome|Device Arm|ICU patients receive the Prima-Temp Temperature Monitoring Patch.
194390|NCT01587014|O1|Outcome|Device Arm|ICU patients receive the Prima-Temp Temperature Monitoring Patch.
194391|NCT01587014|E1|Reported Event|Device Arm|ICU patients receive the Prima-Temp Temperature Monitoring Patch.
194392|NCT01587001|B3|Baseline|Total|Total of all reporting groups
194393|NCT01587001|B2|Baseline|Matching Placebo|Placebo: Matching placebo three times daily for 8 weeks.
194394|NCT01587001|B1|Baseline|Oral N-acetyl-cysteine|"oral NAC 900mg three times daily for 8 weeks~N-acetyl-cysteine: 900mg three times daily for 8 weeks"
194395|NCT01587001|P2|Participant Flow|Matching Placebo|Placebo: Matching placebo three times daily for 8 weeks.
194396|NCT01587001|P1|Participant Flow|Oral N-acetyl-cysteine|N-acetyl-cysteine: 900mg three times daily for 8 weeks
194397|NCT01587001|O2|Outcome|Matching Placebo|Placebo: Matching placebo three times daily for 8 weeks.
194398|NCT01587001|O1|Outcome|Oral N-acetyl-cysteine|"oral NAC 900mg three times daily for 8 weeks~N-acetyl-cysteine: 900mg three times daily for 8 weeks"
194399|NCT01587001|O2|Outcome|Matching Placebo|Placebo: Matching placebo three times daily for 8 weeks.
194400|NCT01587001|O1|Outcome|Oral N-acetyl-cysteine|N-acetyl-cysteine: 900mg three times daily for 8 weeks
194401|NCT01587001|E2|Reported Event|Matching Placebo|Placebo: Matching placebo three times daily for 8 weeks.
194402|NCT01587001|E1|Reported Event|Oral N-acetyl-cysteine|N-acetyl-cysteine: 900mg three times daily for 8 weeks
194403|NCT01586975|B4|Baseline|Total|Total of all reporting groups
194404|NCT01586975|B3|Baseline|Aspiring >300 mg|Aspirin >300 mg QD
194405|NCT01586975|B2|Baseline|Aspirin 81 mg|Aspirin 81 mg QD
194406|NCT01586975|B1|Baseline|Clopidogrel 75 mg|Clopidogrel 75 mg QD
194407|NCT01586975|P3|Participant Flow|Aspirin > 300 mg|Aspiring > 300 mg QD
194408|NCT01586975|P2|Participant Flow|Aspirin 81 mg|Aspirin 81 mg QD
194409|NCT01586975|P1|Participant Flow|Clopidogrel 75 mg|Clopidogrel 75 mg QD
194410|NCT01586975|O3|Outcome|Aspirin > 300 mg|open-label Aspirin
194411|NCT01586975|O2|Outcome|Aspirin 81 mg|open label Aspirin
194412|NCT01586975|O1|Outcome|Clopidogrel 75 mg|Clopidogrel 75 mg QD
194413|NCT01586975|E3|Reported Event|Aspirin >300 mg|Aspirin >300 mg QD
194414|NCT01586975|E2|Reported Event|Aspirin 81 mg|Aspirin 81 mg QD
194415|NCT01586975|E1|Reported Event|Clopidogrel 75 mg|Clopidogrel 75 mg QD
194416|NCT01586962|B1|Baseline|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
194417|NCT01586962|P1|Participant Flow|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
194418|NCT01586962|O1|Outcome|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
194419|NCT01586962|O1|Outcome|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
194420|NCT01586962|O1|Outcome|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
194421|NCT01586962|E1|Reported Event|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
194422|NCT01586897|B3|Baseline|Total|Total of all reporting groups
194423|NCT01586897|B2|Baseline|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care~While PCPs were randomized, analyses were at the patient level. Characteristics presented represent eligible patients of randomized PCPs."
194424|NCT01586897|B1|Baseline|Use of Medication Metronome|"Medication Metronome: PCPs allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid.~While PCPs were randomized, analyses were at the patient level. Characteristics presented represent eligible patients of randomized PCPs."
194425|NCT01586897|P2|Participant Flow|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care~26 Primary Care Physicians randomized to Usual Care, with 1606 patients analyzed."
194426|NCT01586897|P1|Participant Flow|Use of Medication Metronome|"Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid.~26 Primary Care Physicians were randomized to Use of Medication Metronome with 2049 patients analyzed."
194427|NCT01586897|O2|Outcome|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care"
194428|NCT01586897|O1|Outcome|Use of Medication Metronome|Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid
194429|NCT01586897|O2|Outcome|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care"
194430|NCT01586897|O1|Outcome|Use of Medication Metronome|Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid
194431|NCT01586897|O2|Outcome|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care"
194432|NCT01586897|O1|Outcome|Use of Medication Metronome|Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid
194433|NCT01586897|O2|Outcome|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care"
194434|NCT01586897|O1|Outcome|Use of Medication Metronome|Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid
194435|NCT01586897|O2|Outcome|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care"
194436|NCT01586897|O1|Outcome|Use of Medication Metronome|Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid
194437|NCT01586897|E4|Reported Event|Usual Care - Patients|"Patients of PCPs allocated to Usual Care were eligible for our outcomes if prescribed a new study medication or if they experienced a dose change of a study medication."
194438|NCT01586897|E3|Reported Event|Use of Medication Metronome - Patients|"Patients of PCPs allocated to the Use of Medication Metronome were eligible for our outcomes if prescribed a new study medication or if they experienced a dose change of a study medication."
194439|NCT01586897|E2|Reported Event|Usual Care - PCPs|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care"
194440|NCT01586897|E1|Reported Event|Use of Medication Metronome - PCPs|Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipidemia.
194441|NCT01586819|B3|Baseline|Total|Total of all reporting groups
194442|NCT01586819|B2|Baseline|Chemical Peel Only|After cleansing the face with a pre-treatment cleansed composed of water and alcohol, the Jessner's peel solution [a combination of resorcinol (14g), salicylic acid (14g), and lactic acid (85%) in ethanol (95%)] will be applied to the entire face with a large cotton swab. The mixture will be left in place for a few minutes, and then the face will be wiped clean with water. Next, the TCA peel [35% Trichloroacetic acid] will be applied around the eyes. After leaving in place for a few minutes, cool, iced washcloths will be applied and the face will be wiped clean with water. Wound care regimen will consist of dilute acetic acid and either Aquaphor or petroleum jelly.
194443|NCT01586819|B1|Baseline|Botulinum Toxin|The botulinum toxin will be injected into the wrinkles. The injections will take about 10 minutes to complete. Five follow-up visits will be scheduled at 1-7 days, 7-10 days, 2.5-3 weeks, and 12-14 weeks.
194444|NCT01586819|P2|Participant Flow|Chemical Peel Only|After cleansing the face with a pre-treatment cleansed composed of water and alcohol, the Jessner's peel solution [a combination of resorcinol (14g), salicylic acid (14g), and lactic acid (85%) in ethanol (95%)] will be applied to the entire face with a large cotton swab. The mixture will be left in place for a few minutes, and then the face will be wiped clean with water. Next, the TCA peel [35% Trichloroacetic acid] will be applied around the eyes. After leaving in place for a few minutes, cool, iced washcloths will be applied and the face will be wiped clean with water. Wound care regimen will consist of dilute acetic acid and either Aquaphor or petroleum jelly.
194445|NCT01586819|P1|Participant Flow|Botulinum Toxin|The botulinum toxin will be injected into the wrinkles. The injections will take about 10 minutes to complete. Five follow-up visits will be scheduled at 1-7 days, 7-10 days, 2.5-3 weeks, and 12-14 weeks.
194446|NCT01586819|O2|Outcome|Chemical Peel Only|After cleansing the face with a pre-treatment cleansed composed of water and alcohol, the Jessner's peel solution [a combination of resorcinol (14g), salicylic acid (14g), and lactic acid (85%) in ethanol (95%)] will be applied to the entire face with a large cotton swab. The mixture will be left in place for a few minutes, and then the face will be wiped clean with water. Next, the TCA peel [35% Trichloroacetic acid] will be applied around the eyes. After leaving in place for a few minutes, cool, iced washcloths will be applied and the face will be wiped clean with water. Wound care regimen will consist of dilute acetic acid and either Aquaphor or petroleum jelly.
194447|NCT01586819|O1|Outcome|Botulinum Toxin|The botulinum toxin will be injected into the wrinkles. The injections will take about 10 minutes to complete. Five follow-up visits will be scheduled at 1-7 days, 7-10 days, 2.5-3 weeks, and 12-14 weeks.
194448|NCT01586819|O2|Outcome|Chemical Peel Only|After cleansing the face with a pre-treatment cleansed composed of water and alcohol, the Jessner's peel solution [a combination of resorcinol (14g), salicylic acid (14g), and lactic acid (85%) in ethanol (95%)] will be applied to the entire face with a large cotton swab. The mixture will be left in place for a few minutes, and then the face will be wiped clean with water. Next, the TCA peel [35% Trichloroacetic acid] will be applied around the eyes. After leaving in place for a few minutes, cool, iced washcloths will be applied and the face will be wiped clean with water. Wound care regimen will consist of dilute acetic acid and either Aquaphor or petroleum jelly.
194449|NCT01586819|O1|Outcome|Botulinum Toxin|The botulinum toxin will be injected into the wrinkles. The injections will take about 10 minutes to complete. Five follow-up visits will be scheduled at 1-7 days, 7-10 days, 2.5-3 weeks, and 12-14 weeks.
194450|NCT01586819|E2|Reported Event|Chemical Peel Only|After cleansing the face with a pre-treatment cleansed composed of water and alcohol, the Jessner's peel solution [a combination of resorcinol (14g), salicylic acid (14g), and lactic acid (85%) in ethanol (95%)] will be applied to the entire face with a large cotton swab. The mixture will be left in place for a few minutes, and then the face will be wiped clean with water. Next, the TCA peel [35% Trichloroacetic acid] will be applied around the eyes. After leaving in place for a few minutes, cool, iced washcloths will be applied and the face will be wiped clean with water. Wound care regimen will consist of dilute acetic acid and either Aquaphor or petroleum jelly.
194451|NCT01586819|E1|Reported Event|Botulinum Toxin|The botulinum toxin will be injected into the wrinkles. The injections will take about 10 minutes to complete. Five follow-up visits will be scheduled at 1-7 days, 7-10 days, 2.5-3 weeks, and 12-14 weeks.
194452|NCT01586806|B4|Baseline|Total|Total of all reporting groups
194453|NCT01586806|B3|Baseline|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
194454|NCT01586806|B2|Baseline|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
194455|NCT01586806|B1|Baseline|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
194456|NCT01586806|P3|Participant Flow|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
194457|NCT01586806|P2|Participant Flow|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
194458|NCT01586806|P1|Participant Flow|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
194459|NCT01586806|O3|Outcome|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
194460|NCT01586806|O2|Outcome|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
194461|NCT01586806|O1|Outcome|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
194462|NCT01586806|O3|Outcome|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
194463|NCT01586806|O2|Outcome|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
194464|NCT01586806|O1|Outcome|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
194465|NCT01586806|O3|Outcome|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
194466|NCT01586806|O2|Outcome|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
194467|NCT01586806|O1|Outcome|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
194468|NCT01586806|O3|Outcome|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
194469|NCT01586806|O2|Outcome|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
194470|NCT01586806|O1|Outcome|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
194471|NCT01586806|O3|Outcome|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
194472|NCT01586806|O2|Outcome|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
194473|NCT01586806|O1|Outcome|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
194474|NCT01586806|E3|Reported Event|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
194475|NCT01586806|E2|Reported Event|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
194476|NCT01586806|E1|Reported Event|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
194477|NCT01586364|B1|Baseline|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194478|NCT01586364|P1|Participant Flow|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194479|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194480|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194481|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194482|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194483|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194484|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194485|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194486|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194487|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194488|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194489|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194490|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194491|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194492|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194493|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194494|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194495|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194496|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194497|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194498|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194499|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194500|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194501|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194502|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194503|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194504|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194505|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194506|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194507|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194508|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194509|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194510|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194511|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194512|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194513|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194514|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194515|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194516|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194517|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194518|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194519|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194520|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194521|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194522|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194523|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194524|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194525|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194526|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194527|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194528|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194529|NCT01586364|E1|Reported Event|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
194530|NCT01586338|B1|Baseline|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
194531|NCT01586338|P1|Participant Flow|Synvisc|Three intra-articular (IA) injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
194532|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
194533|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
194534|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
194535|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
194536|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
194537|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
194538|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
194539|NCT01586338|E1|Reported Event|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
194540|NCT01586312|B3|Baseline|Total|Total of all reporting groups
194541|NCT01586312|B2|Baseline|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)~Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
194542|NCT01586312|B1|Baseline|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.~Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
194543|NCT01586312|P2|Participant Flow|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)~Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
194544|NCT01586312|P1|Participant Flow|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.~Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
194545|NCT01586312|O2|Outcome|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)~Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
194546|NCT01586312|O1|Outcome|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.~Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
194547|NCT01586312|O2|Outcome|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)~Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
194548|NCT01586312|O1|Outcome|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.~Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
194549|NCT01586312|O2|Outcome|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)~Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
194550|NCT01586312|O1|Outcome|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.~Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
194551|NCT01586312|E2|Reported Event|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)~Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
194552|NCT01586312|E1|Reported Event|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.~Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
194553|NCT01586195|B1|Baseline|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
194554|NCT01586195|P1|Participant Flow|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 milligram (mg) orally twice daily (BID) until disease progression.
194555|NCT01586195|O1|Outcome|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
194556|NCT01586195|O1|Outcome|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
194557|NCT01586195|O1|Outcome|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
194558|NCT01586195|O1|Outcome|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
194559|NCT01586195|O1|Outcome|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
194560|NCT01586195|O1|Outcome|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
194561|NCT01586195|O1|Outcome|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
194562|NCT01586195|O1|Outcome|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
194563|NCT01586195|E1|Reported Event|Vemurafenib|Participants received vemurafenib 960 mg orally BID.
194564|NCT01586156|B4|Baseline|Total|Total of all reporting groups
194565|NCT01586156|B3|Baseline|Placebo Arm|"Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight for the first-dose challenge of carvedilol. After one week run in phase, subjects will be placed on placebo. Subjects and Investigators will be blinded to the group assignment for the duration of the study.~Carvedilol placebo: Placebo taken twice daily for 6 months"
194566|NCT01586156|B2|Baseline|Escalation-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 2 will receive carvedilol in a dose escalation scheme. They will be given 3.125mg tablets to take twice daily for one week, followed by 6.25 mg twice daily for one week, followed by 12.5mg twice daily for one week with the option to increase to the max dose of 25mg twice daily for the remainder of the study. This is the escalating dose Carvedilol
194567|NCT01586156|B1|Baseline|Low-fixed-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 1 will receive 3.125mg twice daily for six months. This is the low fixed dose Carvedilol
194568|NCT01586156|P3|Participant Flow|Escalation-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 2 will receive carvedilol in a dose escalation scheme. They will be given 3.125mg tablets to take twice daily for one week, followed by 6.25 mg twice daily for one week, followed by 12.5mg twice daily for one week with the option to increase to the max dose of 25mg twice daily for the remainder of the study. This is the escalating dose Carvedilol
194569|NCT01586156|P2|Participant Flow|Placebo Arm|"Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight for the first-dose challenge of carvedilol. After one week run in phase, subjects will be placed on placebo. Subjects and Investigators will be blinded to the group assignment for the duration of the study.~Carvedilol placebo: Placebo taken twice daily for 6 months"
194570|NCT01586156|P1|Participant Flow|Low-fixed-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 1 will receive 3.125mg twice daily for six months. This is the low fixed dose Carvedilol
194571|NCT01586156|O3|Outcome|Escalation-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 2 will receive carvedilol in a dose escalation scheme. They will be given 3.125mg tablets to take twice daily for one week, followed by 6.25 mg twice daily for one week, followed by 12.5mg twice daily for one week with the option to increase to the max dose of 25mg twice daily for the remainder of the study. This is the escalating dose Carvedilol
194572|NCT01586156|O2|Outcome|Low-fixed-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 1 will receive 3.125mg twice daily for six months. This is the low fixed dose Carvedilol
194573|NCT01586156|O1|Outcome|Placebo Arm|"Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight for the first-dose challenge of carvedilol. After one week run in phase, subjects will be placed on placebo. Subjects and Investigators will be blinded to the group assignment for the duration of the study.~Carvedilol placebo: Placebo taken twice daily for 6 months"
194574|NCT01586156|O3|Outcome|Escalation-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 2 will receive carvedilol in a dose escalation scheme. They will be given 3.125mg tablets to take twice daily for one week, followed by 6.25 mg twice daily for one week, followed by 12.5mg twice daily for one week with the option to increase to the max dose of 25mg twice daily for the remainder of the study. This is the escalating dose Carvedilol
194575|NCT01586156|O2|Outcome|Low-fixed-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 1 will receive 3.125mg twice daily for six months. This is the low fixed dose Carvedilol
194576|NCT01586156|O1|Outcome|Placebo Arm|"Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight for the first-dose challenge of carvedilol. After one week run in phase, subjects will be placed on placebo. Subjects and Investigators will be blinded to the group assignment for the duration of the study.~Carvedilol placebo: Placebo taken twice daily for 6 months"
194705|NCT01585558|B3|Baseline|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194706|NCT01585558|B2|Baseline|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194577|NCT01586156|O3|Outcome|Escalation-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 2 will receive carvedilol in a dose escalation scheme. They will be given 3.125mg tablets to take twice daily for one week, followed by 6.25 mg twice daily for one week, followed by 12.5mg twice daily for one week with the option to increase to the max dose of 25mg twice daily for the remainder of the study. This is the escalating dose Carvedilol
194578|NCT01586156|O2|Outcome|Low-fixed-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 1 will receive 3.125mg twice daily for six months. This is the low fixed dose Carvedilol
194579|NCT01586156|O1|Outcome|Placebo Arm|"Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight for the first-dose challenge of carvedilol. After one week run in phase, subjects will be placed on placebo. Subjects and Investigators will be blinded to the group assignment for the duration of the study.~Carvedilol placebo: Placebo taken twice daily for 6 months"
194580|NCT01586156|O3|Outcome|Escalation-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 2 will receive carvedilol in a dose escalation scheme. They will be given 3.125mg tablets to take twice daily for one week, followed by 6.25 mg twice daily for one week, followed by 12.5mg twice daily for one week with the option to increase to the max dose of 25mg twice daily for the remainder of the study. This is the escalating dose Carvedilol
194581|NCT01586156|O2|Outcome|Low-fixed-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 1 will receive 3.125mg twice daily for six months. This is the low fixed dose Carvedilol
194582|NCT01586156|O1|Outcome|Placebo Arm|"Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight for the first-dose challenge of carvedilol. After one week run in phase, subjects will be placed on placebo. Subjects and Investigators will be blinded to the group assignment for the duration of the study.~Carvedilol placebo: Placebo taken twice daily for 6 months"
194583|NCT01586156|O3|Outcome|Escalation-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 2 will receive carvedilol in a dose escalation scheme. They will be given 3.125mg tablets to take twice daily for one week, followed by 6.25 mg twice daily for one week, followed by 12.5mg twice daily for one week with the option to increase to the max dose of 25mg twice daily for the remainder of the study. This is the escalating dose Carvedilol
194584|NCT01586156|O2|Outcome|Low-fixed-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 1 will receive 3.125mg twice daily for six months. This is the low fixed dose Carvedilol
194585|NCT01586156|O1|Outcome|Placebo Arm|"Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight for the first-dose challenge of carvedilol. After one week run in phase, subjects will be placed on placebo. Subjects and Investigators will be blinded to the group assignment for the duration of the study.~Carvedilol placebo: Placebo taken twice daily for 6 months"
194586|NCT01586156|O3|Outcome|Escalation-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 2 will receive carvedilol in a dose escalation scheme. They will be given 3.125mg tablets to take twice daily for one week, followed by 6.25 mg twice daily for one week, followed by 12.5mg twice daily for one week with the option to increase to the max dose of 25mg twice daily for the remainder of the study. This is the escalating dose Carvedilol
194587|NCT01586156|O2|Outcome|Low-fixed-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 1 will receive 3.125mg twice daily for six months. This is the low fixed dose Carvedilol
194588|NCT01586156|O1|Outcome|Placebo Arm|"Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight for the first-dose challenge of carvedilol. After one week run in phase, subjects will be placed on placebo. Subjects and Investigators will be blinded to the group assignment for the duration of the study.~Carvedilol placebo: Placebo taken twice daily for 6 months"
194589|NCT01586156|O3|Outcome|Escalation-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 2 will receive carvedilol in a dose escalation scheme. They will be given 3.125mg tablets to take twice daily for one week, followed by 6.25 mg twice daily for one week, followed by 12.5mg twice daily for one week with the option to increase to the max dose of 25mg twice daily for the remainder of the study. This is the escalating dose Carvedilol
194707|NCT01585558|B1|Baseline|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194590|NCT01586156|O2|Outcome|Low-fixed-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 1 will receive 3.125mg twice daily for six months. This is the low fixed dose Carvedilol
194591|NCT01586156|O1|Outcome|Placebo Arm|"Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight for the first-dose challenge of carvedilol. After one week run in phase, subjects will be placed on placebo. Subjects and Investigators will be blinded to the group assignment for the duration of the study.~Carvedilol placebo: Placebo taken twice daily for 6 months"
194592|NCT01586156|E3|Reported Event|Escalation-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 2 will receive carvedilol in a dose escalation scheme. They will be given 3.125mg tablets to take twice daily for one week, followed by 6.25 mg twice daily for one week, followed by 12.5mg twice daily for one week with the option to increase to the max dose of 25mg twice daily for the remainder of the study. This is the escalating dose Carvedilol
194593|NCT01586156|E2|Reported Event|Low-fixed-dose Carvedilol|Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 1 will receive 3.125mg twice daily for six months. This is the low fixed dose Carvedilol
194594|NCT01586156|E1|Reported Event|Placebo Arm|"Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight for the first-dose challenge of carvedilol. After one week run in phase, subjects will be placed on placebo. Subjects and Investigators will be blinded to the group assignment for the duration of the study.~Carvedilol placebo: Placebo taken twice daily for 6 months"
194595|NCT01586026|B1|Baseline|Combined Demographics|Demographics of 171 subjects that contributed to final data analysis
194596|NCT01586026|P3|Participant Flow|Group C|Maintenance flushes at days 57+
194597|NCT01586026|P2|Participant Flow|Group B|Maintenance flushes at days 29-56
194598|NCT01586026|P1|Participant Flow|Group A|Maintenance flushes at days 1-28
194599|NCT01586026|O3|Outcome|Group C|Maintenance flushes at days 57+
194600|NCT01586026|O2|Outcome|Group B|Maintenance flushes at days 29-56
194601|NCT01586026|O1|Outcome|Group A|Maintenance flushes at days 1-28
194602|NCT01586026|E3|Reported Event|Group C|Maintenance flushes at days 57+
194603|NCT01586026|E2|Reported Event|Group B|Maintenance flushes at days 29-56
194604|NCT01586026|E1|Reported Event|Group A|Maintenance flushes at days 1-28
194605|NCT01585987|B3|Baseline|Total|Total of all reporting groups
194606|NCT01585987|B2|Baseline|All Best Supportive Care (BSC)|BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment.
194607|NCT01585987|B1|Baseline|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
194608|NCT01585987|P2|Participant Flow|All Best Supportive Care (BSC)|All BSC includes both active and non-active BSC. Active BSC includes the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. In non-active BSC, the fluoropyrimidine used during lead-in chemotherapy was not continued on study and no other chemotherapy or active treatment was used
194609|NCT01585987|P1|Participant Flow|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
194610|NCT01585987|O2|Outcome|All Best Supportive Care (BSC)|BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.
194611|NCT01585987|O1|Outcome|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
194612|NCT01585987|O2|Outcome|All Best Supportive Care (BSC)|BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.
194613|NCT01585987|O1|Outcome|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
194614|NCT01585987|O2|Outcome|All Best Supportive Care (BSC)|BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.
194708|NCT01585558|P3|Participant Flow|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194615|NCT01585987|O1|Outcome|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
194616|NCT01585987|O2|Outcome|All Best Supportive Care (BSC)|BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.
194617|NCT01585987|O1|Outcome|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
194618|NCT01585987|O2|Outcome|All Best Supportive Care (BSC)|BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.
194619|NCT01585987|O1|Outcome|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
194620|NCT01585987|E3|Reported Event|Non-Active BSC|Non-Active BSC involves supportive care with cessation of chemotherapy (no active drug)
194621|NCT01585987|E2|Reported Event|Active Best Supportive Care (BSC)|Active BSC includes the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization)
194622|NCT01585987|E1|Reported Event|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
194623|NCT01585961|B1|Baseline|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
194624|NCT01585961|P1|Participant Flow|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
194625|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
194626|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
194627|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
194628|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
194629|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
194630|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
194631|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
198970|NCT01569295|B3|Baseline|Total|Total of all reporting groups
194632|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
194633|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
194634|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
194635|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
194636|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
194637|NCT01585961|E1|Reported Event|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
194638|NCT01585779|B3|Baseline|Total|Total of all reporting groups
194639|NCT01585779|B2|Baseline|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194640|NCT01585779|B1|Baseline|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194641|NCT01585779|P2|Participant Flow|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194642|NCT01585779|P1|Participant Flow|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194643|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194644|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194645|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194646|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194647|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194648|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194649|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194650|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194651|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194652|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194653|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194654|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194655|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194656|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194657|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194658|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194659|NCT01585779|O2|Outcome|Tri-Ad® Implant|The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
194709|NCT01585558|P2|Participant Flow|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194710|NCT01585558|P1|Participant Flow|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
199810|NCT01566773|O5|Outcome|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
194660|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194661|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194662|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194663|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194664|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194665|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194666|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194667|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194668|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194669|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194670|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194671|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194672|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194711|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194712|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
199811|NCT01566773|O4|Outcome|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
194673|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194674|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194675|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194676|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194677|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194678|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194679|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194680|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194681|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194682|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194683|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194684|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194685|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194713|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194714|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
199812|NCT01566773|O3|Outcome|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
194686|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194687|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194688|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194689|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194690|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194691|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194692|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194693|NCT01585779|E2|Reported Event|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194694|NCT01585779|E1|Reported Event|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
194695|NCT01585597|B1|Baseline|Mild Hypothermia|"Reduction of body temperature to 34 degrees centigrade.~Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour."
194696|NCT01585597|P1|Participant Flow|Mild Hypothermia|"Reduction of body temperature to 34 degrees centigrade.~Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour."
194697|NCT01585597|O1|Outcome|Mild Hypothermia|"Reduction of body temperature to 34 degrees centigrade.~Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour."
194698|NCT01585597|O1|Outcome|Mild Hypothermia|"Reduction of body temperature to 34 degrees centigrade.~Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour."
194699|NCT01585597|E1|Reported Event|Mild Hypothermia|"Reduction of body temperature to 34 degrees centigrade.~Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour."
194700|NCT01585584|B1|Baseline|Victrelis Triple|All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple)
194701|NCT01585584|P1|Participant Flow|Victrelis Triple|All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple)
194702|NCT01585584|O1|Outcome|Victrelis Triple|All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple)
194703|NCT01585584|E1|Reported Event|Victrelis Triple|All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple)
194704|NCT01585558|B4|Baseline|Total|Total of all reporting groups
195363|NCT01583530|O4|Outcome|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
194715|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194716|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194717|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194718|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194719|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194720|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194721|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194722|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194723|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194724|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194725|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194726|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194727|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194728|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194729|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194730|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194731|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194732|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194733|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194734|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194735|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194736|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194737|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194738|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194739|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194740|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194741|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194742|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194743|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194744|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194745|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194746|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194747|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194748|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194749|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194750|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194751|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194752|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194753|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194754|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
199813|NCT01566773|O2|Outcome|GP MDI 9 µg BID|GP MDI 9 µg BID.
194755|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194756|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194757|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194758|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194759|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194760|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194761|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194762|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194763|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194764|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194765|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194766|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194767|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194768|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194769|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194770|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194771|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194772|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194773|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194774|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194775|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194776|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194777|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194778|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194779|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194780|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194781|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194782|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194783|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194784|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194785|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194786|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194787|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194788|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194789|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194790|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194791|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194792|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194793|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194794|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
199814|NCT01566773|O1|Outcome|GP MDI 18 µg BID|GP MDI 18 µg BID.
194795|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194796|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194797|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194798|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194799|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194800|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194801|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194802|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194803|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194804|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194805|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194806|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194807|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194808|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194809|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194810|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194811|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194812|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194813|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194814|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194815|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194816|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194817|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194818|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194819|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194820|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194821|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194822|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194823|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194824|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194825|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194826|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194827|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194828|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194829|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194830|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194831|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194832|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194833|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194834|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
199822|NCT01566773|O1|Outcome|GP MDI 18 µg BID|GP MDI 18 µg BID.
194835|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194836|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194837|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194838|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194839|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194840|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194841|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194842|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194843|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194844|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194845|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194846|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194847|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194848|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194849|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194850|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194851|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194852|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194853|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194854|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194855|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194856|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194857|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194858|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194859|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194860|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194861|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194862|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194863|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194864|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194865|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194866|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194867|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194868|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194869|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194870|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194871|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194872|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194873|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194874|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
201911|NCT01560975|O1|Outcome|POAG/CPAP|POAG patients with CPAP therapy
194875|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194876|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194877|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194878|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194879|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194880|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194881|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194882|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194883|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194884|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194885|NCT01585558|E3|Reported Event|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
194886|NCT01585558|E2|Reported Event|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
194887|NCT01585558|E1|Reported Event|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
194888|NCT01585441|B3|Baseline|Total|Total of all reporting groups
194889|NCT01585441|B2|Baseline|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
194890|NCT01585441|B1|Baseline|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
194891|NCT01585441|P2|Participant Flow|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
194892|NCT01585441|P1|Participant Flow|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
194893|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
194894|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
194895|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
194896|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
194897|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
194898|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
194899|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
194900|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
194901|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
194902|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
194903|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
194927|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
194904|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
194905|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
194906|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
194907|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
194908|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
194909|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
194910|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
194911|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
194912|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
194913|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
194914|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
194915|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
194916|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
194917|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
194918|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
194919|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
194920|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
194921|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
194922|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
194923|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
194924|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
194925|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
194926|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
194928|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
194929|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
194930|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
194931|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
194932|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
194933|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
194934|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
194935|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
194936|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
194937|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
194938|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
194939|NCT01585441|E2|Reported Event|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
194940|NCT01585441|E1|Reported Event|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
194941|NCT01585428|B3|Baseline|Total|Total of all reporting groups
194942|NCT01585428|B2|Baseline|NonCervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
194943|NCT01585428|B1|Baseline|Cervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin.~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
194944|NCT01585428|P2|Participant Flow|NonCervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
195002|NCT01585207|O1|Outcome|Vigabatrin|3 tablets, bid for 8 weeks
195003|NCT01585207|E1|Reported Event|Vigabatrin|3 tablets, bid for 8 weeks
195004|NCT01585168|B3|Baseline|Total|Total of all reporting groups
195005|NCT01585168|B2|Baseline|Family History Negative (FHN)|People who have no affected first- or second-degree relatives.
194945|NCT01585428|P1|Participant Flow|Cervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin.~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
194946|NCT01585428|O2|Outcome|NonCervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
194947|NCT01585428|O1|Outcome|Cervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin.~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
194948|NCT01585428|O2|Outcome|NonCervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
194949|NCT01585428|O1|Outcome|Cervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
194950|NCT01585428|E2|Reported Event|NonCervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
194951|NCT01585428|E1|Reported Event|Cervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin.~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
194952|NCT01585324|B1|Baseline|Peginterferon Alpha-2a + Ribavirin|Participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 mcg subcutaneously once a week and ribavirin tablet, 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally split into 2 daily doses, for a total of 48 weeks.
194953|NCT01585324|P1|Participant Flow|Peginterferon Alpha-2a + Ribavirin|Participants infected with hepatitis C virus (HCV) genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 micrograms (mcg) subcutaneously once a week and ribavirin tablet, 1000-1200 milligrams (mg) by body weight (1000 mg if weight less than (<) 75 kilogram [kg]; 1200 mg if weight greater than or equal to (≥) 75 kg) orally split into 2 daily doses, for a total of 48 weeks.
203392|NCT01553318|O2|Outcome|Placebo|placebo group
194954|NCT01585324|O2|Outcome|Participants Without SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
194955|NCT01585324|O1|Outcome|Participants With SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
194956|NCT01585324|O2|Outcome|Participants Without SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
194957|NCT01585324|O1|Outcome|Participants With SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
194958|NCT01585324|O2|Outcome|Participants Without SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
194959|NCT01585324|O1|Outcome|Participants With SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
194960|NCT01585324|O2|Outcome|Participants Without SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
194961|NCT01585324|O1|Outcome|Participants With SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
194962|NCT01585324|O2|Outcome|Participants Without SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
194963|NCT01585324|O1|Outcome|Participants With SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
194964|NCT01585324|O2|Outcome|Participants Without SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
194965|NCT01585324|O1|Outcome|Participants With SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
195006|NCT01585168|B1|Baseline|Family History Positive (FHP)|People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
194966|NCT01585324|O1|Outcome|Peginterferon Alpha-2a + Ribavirin|Participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 mcg subcutaneously once a week and ribavirin tablet, 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally split into 2 daily doses, for a total of 48 weeks.
194967|NCT01585324|E1|Reported Event|Peginterferon Alpha-2a + Ribavirin|Participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 mcg subcutaneously once a week and ribavirin tablet, 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally split into 2 daily doses, for a total of 48 weeks.
194968|NCT01585272|B1|Baseline|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
194969|NCT01585272|P1|Participant Flow|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
194970|NCT01585272|O1|Outcome|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
194971|NCT01585272|O1|Outcome|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
194972|NCT01585272|O1|Outcome|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
194973|NCT01585272|O1|Outcome|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
194974|NCT01585272|O1|Outcome|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
194975|NCT01585272|E1|Reported Event|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
194976|NCT01585246|B6|Baseline|Total|Total of all reporting groups
194977|NCT01585246|B5|Baseline|Placebo Comparator: Phase 2: RCT Phase- Placebo|Patients received Soybean Oil Soft Gel as the placebo treatment
194978|NCT01585246|B4|Baseline|Active Comparator: Phase 2: RCT Phase- Saw Palmetto|Patients received the predetermine the maximum therapeutic dose of Saw Palmetto Soft Gel capsules in phase 1, which is 960mg
194979|NCT01585246|B3|Baseline|Phase 1: Saw Palmetto Soft Gel 960mg/Day|Participants in this arm received 960mg/day of Saw Palmetto Soft Gel capsules.
194980|NCT01585246|B2|Baseline|Phase 1: Saw Palmetto Soft Gel 640mg/Day|Participants in this arm received 640mg/day of Saw Palmetto Soft Gel capsules.
194981|NCT01585246|B1|Baseline|Phase 1: Saw Palmetto Soft Gel 320mg/Day|Participants in this arm received 320mg/day of Saw Palmetto Soft Gel capsules.
194982|NCT01585246|P5|Participant Flow|Phase 2: RCT Phase- Placebo|Patients received Soybean Oil Soft Gel as the placebo treatment
194983|NCT01585246|P4|Participant Flow|Phase 2: RCT Phase- Saw Palmetto|Patients received the predetermine the maximum therapeutic dose of Saw Palmetto Soft Gel capsules in phase 1, which is 960mg.
194984|NCT01585246|P3|Participant Flow|Phase 1: Saw Palmetto Soft Gel 960mg/Day|Participants in this arm received 960mg/day of Saw Palmetto Soft Gel capsules.
194985|NCT01585246|P2|Participant Flow|Phase 1: Saw Palmentto Soft Gel 640mg/Day|Participants in this arm received 640mg/day of Saw Palmetto Soft Gel capsules.
194986|NCT01585246|P1|Participant Flow|Phase 1: Saw Palmetto Soft Gel 320mg/Day|Participants in this arm received 320mg/day of Saw Palmetto Soft Gel capsules.
194987|NCT01585246|O3|Outcome|Phase I: Saw Palmetto Soft Gel 960mg/Day|Participants in this arm received 960 mg/day of Saw Palmetto Soft Gel capsules.
194988|NCT01585246|O2|Outcome|Phase I: Saw Palmetto Soft Gel 640mg/Day|Participants in this arm received 640mg/day of Saw Palmetto Soft Gel capsules.
194989|NCT01585246|O1|Outcome|Phase 1: Saw Palmetto Soft Gel 320mg/Day|Participants in this arm received 320mg/day of Saw Palmetto Soft Gel capsules.
194990|NCT01585246|O2|Outcome|Phase 2: RCT Phase- Placebo|Patients received Soybean Oil Soft Gel as the placebo treatment
194991|NCT01585246|O1|Outcome|Phase 2: RCT Phase- Saw Palmetto|Patients received the predetermine the maximum therapeutic dose of Saw Palmetto Soft Gel capsules in phase 1, which is 960mg.
194992|NCT01585246|O5|Outcome|Phase 2: Placebo RCT|Men assigned to the placebo in the pilot RCT Phase
194993|NCT01585246|O4|Outcome|Phase 2: Saw Palmetto 960 mg RCT|Men assigned to the 960mg/Day of Saw Palmetto in the pilot RCT Phase
194994|NCT01585246|O3|Outcome|Phase 1: Men in 960mg/Day DFP|Men assigned to the 960mg/Day group in the dose finding phase.
194995|NCT01585246|O2|Outcome|Phase 1: Men in 640mg/Day DFP|Men assigned to the 640mg/Day group in the dose finding phase.
194996|NCT01585246|O1|Outcome|Phase 1: Men in 320mg/Day DFP|Men assigned to the 320mg/Day group in the dose finding phase.
194997|NCT01585246|E3|Reported Event|Phase 2: RCT Phase- Placebo|Patients received Soybean Oil Soft Gel as the placebo treatment
194998|NCT01585246|E2|Reported Event|Phase 2: RCT Phase- Saw Palmetto|Patients received the predetermine the maximum therapeutic dose of Saw Palmetto Soft Gel capsules in phase 1, which is 960 mg.
194999|NCT01585246|E1|Reported Event|Phase 1: The Dose Finding Phase (DFP)|Patients received Saw Palmetto Soft Gel capsules in 320mg or 640mg or 960mg to determine the maximum therapeutic dose.
195000|NCT01585207|B1|Baseline|Vigabatrin|3 tablets, bid for 8 weeks
195001|NCT01585207|P1|Participant Flow|Vigabatrin|3 tablets, bid for 8 weeks
195007|NCT01585168|P4|Participant Flow|Family History Positive (FHP): Placebo, Then Memantine|"Participants received 2 matching placebo tablets on the morning of the first study visit, then received 2-20mg tablets of Memantine on the morning of the second study visit. Visits were approximately 1 week to 1 month a part on average.~Family History Positive (FHP): People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism."
195008|NCT01585168|P3|Participant Flow|Family History Positive (FHP): Memantine, Then Placebo|"Participants received 2-20mg tablets of Memantine on the morning of the first study visit, then received 2 matching placebo tablets on the morning of the second study visit. Visits were approximately 1 week to 1 month a part on average.~Family History Positive (FHP): People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism."
195009|NCT01585168|P2|Participant Flow|Family History Negative (FHN): Placebo, Then Memantine|"Participants received 2 matching placebo tablets on the morning of the first study visit, then received 2-20mg tablets of Memantine on the morning of the second study visit. Visits were approximately 1 week to 1 month a part on average.~Family History Negative (FHN): People who have no affected first- or second-degree relatives."
195010|NCT01585168|P1|Participant Flow|Family History Negative (FHN): Memantine, Then Placebo|"Participants received 2-20mg tablets of Memantine on the morning of the first study visit, then received 2 matching placebo tablets on the morning of the second study visit. Visits were approximately 1 week to 1 month a part on average.~Family History Negative (FHN): People who have no affected first- or second-degree relatives."
195011|NCT01585168|O4|Outcome|FHP - Placebo|Family History Positive (FHP): People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
195012|NCT01585168|O3|Outcome|FHP - Memantine|Family History Positive (FHP): People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
195013|NCT01585168|O2|Outcome|FHN - Placebo|Family History Negative (FHN): People who have no affected first- or second-degree relatives.
195014|NCT01585168|O1|Outcome|FHN - Memantine|Family History Negative (FHN): People who have no affected first- or second-degree relatives.
195015|NCT01585168|O4|Outcome|FHP - Placebo|Family History Positive (FHP): People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
195016|NCT01585168|O3|Outcome|FHP - Memantine|Family History Positive (FHP): People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
195017|NCT01585168|O2|Outcome|FHN - Placebo|Family History Negative (FHN): People who have no affected first- or second-degree relatives.
195018|NCT01585168|O1|Outcome|FHN - Memantine|Family History Negative (FHN): People who have no affected first- or second-degree relatives.
195019|NCT01585168|O4|Outcome|FHP - Placebo|Family History Positive (FHP): People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
195020|NCT01585168|O3|Outcome|FHP - Memantine|Family History Positive (FHP): People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
195021|NCT01585168|O2|Outcome|FHN - Placebo|Family History Negative (FHN): People who have no affected first- or second-degree relatives.
195022|NCT01585168|O1|Outcome|FHN - Memantine|Family History Negative (FHN): People who have no affected first- or second-degree relatives.
195023|NCT01585168|O4|Outcome|FHP - Placebo|Family History Positive (FHP): People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
195024|NCT01585168|O3|Outcome|FHP - Memantine|Family History Positive (FHP): People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
195025|NCT01585168|O2|Outcome|FHN - Placebo|Family History Negative (FHN): People who have no affected first- or second-degree relatives.
195026|NCT01585168|O1|Outcome|FHN - Memantine|Family History Negative (FHN): People who have no affected first- or second-degree relatives.
195027|NCT01585168|E2|Reported Event|Family History Negative (FHN)|People who have no affected first- or second-degree relatives.
195028|NCT01585168|E1|Reported Event|Family History Positive (FHP)|People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
195029|NCT01585129|B3|Baseline|Total|Total of all reporting groups
195030|NCT01585129|B2|Baseline|No Postpartum Antibiotics|"No further postpartum antibiotics~No postpartum antibiotics: Patients randomized into this arm will not receive any postpartum antibiotics after delivery. They will be managed identically to the other arm in terms of chorioamnionitis (fever pre-delivery). The groups will be managed identically if endometritis (post-partum fever) develops."
195031|NCT01585129|B1|Baseline|Postpartum Antibiotics|"Patients will receive one additional dose of postpartum antibiotics (Clinda, Gentamicin)~Postpartum Antibiotics: Patients randomized into this arm will receive one additional dose of gentamicin (1.5 mg/kg) and clindamycin (900mg) in the postpartum setting."
195032|NCT01585129|P2|Participant Flow|No Postpartum Antibiotics|"No further postpartum antibiotics~No postpartum antibiotics: Patients randomized into this arm will not receive any postpartum antibiotics after delivery. They will be managed identically to the other arm in terms of chorioamnionitis (fever pre-delivery). The groups will be managed identically if endometritis (post-partum fever) develops."
195033|NCT01585129|P1|Participant Flow|Postpartum Antibiotics|"Patients will receive one additional dose of postpartum antibiotics (Clinda, Gentamicin)~Postpartum Antibiotics: Patients randomized into this arm will receive one additional dose of gentamicin (1.5 mg/kg) and clindamycin (900mg) in the postpartum setting."
195034|NCT01585129|O2|Outcome|No Postpartum Antibiotics|"No further postpartum antibiotics~No postpartum antibiotics: Patients randomized into this arm will not receive any postpartum antibiotics after delivery. They will be managed identically to the other arm in terms of chorioamnionitis (fever pre-delivery). The groups will be managed identically if endometritis (post-partum fever) develops."
195035|NCT01585129|O1|Outcome|Postpartum Antibiotics|"Patients will receive one additional dose of postpartum antibiotics (Clinda, Gentamicin)~Postpartum Antibiotics: Patients randomized into this arm will receive one additional dose of gentamicin (1.5 mg/kg) and clindamycin (900mg) in the postpartum setting."
195361|NCT01583530|O2|Outcome|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
195036|NCT01585129|O2|Outcome|No Postpartum Antibiotics|"No further postpartum antibiotics~No postpartum antibiotics: Patients randomized into this arm will not receive any postpartum antibiotics after delivery. They will be managed identically to the other arm in terms of chorioamnionitis (fever pre-delivery). The groups will be managed identically if endometritis (post-partum fever) develops."
195037|NCT01585129|O1|Outcome|Postpartum Antibiotics|"Patients will receive one additional dose of postpartum antibiotics (Clinda, Gentamicin)~Postpartum Antibiotics: Patients randomized into this arm will receive one additional dose of gentamicin (1.5 mg/kg) and clindamycin (900mg) in the postpartum setting."
195038|NCT01585129|O2|Outcome|No Postpartum Antibiotics|"No further postpartum antibiotics~No postpartum antibiotics: Patients randomized into this arm will not receive any postpartum antibiotics after delivery. They will be managed identically to the other arm in terms of chorioamnionitis (fever pre-delivery). The groups will be managed identically if endometritis (post-partum fever) develops."
195039|NCT01585129|O1|Outcome|Postpartum Antibiotics|"Patients will receive one additional dose of postpartum antibiotics (Clinda, Gentamicin)~Postpartum Antibiotics: Patients randomized into this arm will receive one additional dose of gentamicin (1.5 mg/kg) and clindamycin (900mg) in the postpartum setting."
195040|NCT01585129|E2|Reported Event|No Postpartum Antibiotics|"No further postpartum antibiotics~No postpartum antibiotics: Patients randomized into this arm will not receive any postpartum antibiotics after delivery. They will be managed identically to the other arm in terms of chorioamnionitis (fever pre-delivery). The groups will be managed identically if endometritis (post-partum fever) develops."
195041|NCT01585129|E1|Reported Event|Postpartum Antibiotics|"Patients will receive one additional dose of postpartum antibiotics (Clinda, Gentamicin)~Postpartum Antibiotics: Patients randomized into this arm will receive one additional dose of gentamicin (1.5 mg/kg) and clindamycin (900mg) in the postpartum setting."
195042|NCT01585038|B3|Baseline|Total|Total of all reporting groups
195043|NCT01585038|B2|Baseline|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days~Rilpivirine: 25mg orally once daily"
195044|NCT01585038|B1|Baseline|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days~Efavirenz: 600mg orally every evening"
195045|NCT01585038|P2|Participant Flow|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days~Rilpivirine: 25mg orally once daily"
195046|NCT01585038|P1|Participant Flow|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days~Efavirenz: 600mg orally every evening"
195047|NCT01585038|O2|Outcome|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days~Rilpivirine: 25mg orally once daily"
195048|NCT01585038|O1|Outcome|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days~Efavirenz: 600mg orally every evening"
195049|NCT01585038|O2|Outcome|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days~Rilpivirine: 25mg orally once daily"
195050|NCT01585038|O1|Outcome|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days~Efavirenz: 600mg orally every evening"
195051|NCT01585038|O2|Outcome|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days~Rilpivirine: 25mg orally once daily"
195052|NCT01585038|O1|Outcome|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days~Efavirenz: 600mg orally every evening"
195053|NCT01585038|O2|Outcome|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days~Rilpivirine: 25mg orally once daily"
195054|NCT01585038|O1|Outcome|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days~Efavirenz: 600mg orally every evening"
195055|NCT01585038|E2|Reported Event|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days~Rilpivirine: 25mg orally once daily"
195056|NCT01585038|E1|Reported Event|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days~Efavirenz: 600mg orally every evening"
195057|NCT01584843|B5|Baseline|Total|Total of all reporting groups
195058|NCT01584843|B4|Baseline|GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195059|NCT01584843|B3|Baseline|GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD or with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195060|NCT01584843|B2|Baseline|GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195192|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195309|NCT01583647|O2|Outcome|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
195061|NCT01584843|B1|Baseline|Non-treatment, Then GSK1358820|Participants (par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD or with a BSA >=20 PD and <50 PD received no treatment from the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U), 2.5 U, or 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195062|NCT01584843|P6|Participant Flow|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195063|NCT01584843|P5|Participant Flow|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195064|NCT01584843|P4|Participant Flow|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195065|NCT01584843|P3|Participant Flow|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195066|NCT01584843|P2|Participant Flow|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195067|NCT01584843|P1|Participant Flow|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195068|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195193|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195310|NCT01583647|O1|Outcome|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
195069|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195070|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195071|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195072|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195073|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195074|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195075|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195076|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195194|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195195|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195077|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195078|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195079|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195080|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195081|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195082|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195083|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195084|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195196|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195212|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195085|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195086|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195087|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195088|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195089|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195090|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195091|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195092|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195197|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195242|NCT01584518|O2|Outcome|Non CHF Peptide|Diuresis based on clinical judgement without data for CHF-P
195243|NCT01584518|O1|Outcome|CHF Peptide|"Diuresis based on CHF-P~Furosemide: Based on clinical standard per clinician"
195093|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195094|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195095|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195096|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195097|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195098|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195099|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195100|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195198|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195199|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195101|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195102|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195103|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195104|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195105|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195106|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195107|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195108|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195200|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195201|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195109|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195110|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195111|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195112|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195113|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195114|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195115|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195116|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195202|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195244|NCT01584518|E2|Reported Event|Non CHF Peptide|Diuresis based on clinical judgement without data for CHF-P
195245|NCT01584518|E1|Reported Event|CHF Peptide|"Diuresis based on CHF-P~Furosemide: Based on clinical standard per clinician"
195117|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195118|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195119|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195120|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195121|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195122|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195123|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195124|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195203|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195204|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195125|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195126|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195127|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195128|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195129|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195130|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195131|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195132|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195205|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195246|NCT01584479|B5|Baseline|Total|Total of all reporting groups
195247|NCT01584479|B4|Baseline|High Risk Control Group|"2 visits - High Risk~~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
195133|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195134|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195135|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195136|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195137|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195138|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195139|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195140|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195206|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195248|NCT01584479|B3|Baseline|High Risk Experimental Group|"1 visit - High Risk~~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
195141|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195142|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195143|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195144|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195145|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195146|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195147|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195148|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195207|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195208|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195149|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195150|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195151|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195152|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195153|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195154|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195155|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195156|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195209|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195249|NCT01584479|B2|Baseline|Low Risk Control Group|"2 visits - Low Risk~~1200 subjects~- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
203393|NCT01553318|O1|Outcome|Ketotifen|active drug group
195157|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195158|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195159|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195160|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195161|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195162|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195163|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195164|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195210|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195250|NCT01584479|B1|Baseline|Low Risk Experimental Group|"1 visit - Low Risk~~1200 subjects~- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
203394|NCT01553318|O2|Outcome|Placebo|placebo group
195165|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195166|NCT01584843|O4|Outcome|SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195167|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195168|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195169|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195170|NCT01584843|E5|Reported Event|GSK1358820 5.0 U|Par with a BSA greater than or equal to 20 PD and less than 50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195171|NCT01584843|E4|Reported Event|GSK1358820 2.5 U|Participants with BSA of greater than or equal to 10 PD and less than 20 PD or greater than or equal to 20 PD and less than 50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195172|NCT01584843|E3|Reported Event|GSK1358820 1.25 U|Par with a BSA greater than or equal to 10 PD and less than 20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
195211|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195307|NCT01583647|O2|Outcome|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
195173|NCT01584843|E2|Reported Event|Non-treatment, Then GSK1358820|Par with a BSA of greater than or equal to 10 PD and less than 20 PD or greater than or equal to 20 PD and less than 50 PD received no treatment from the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U), 2.5 U, or 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
195174|NCT01584843|E1|Reported Event|Non-treatment|Participants (par) with a BSA of greater than or equal to 10 PD and less than 20 PD or greater than or equal to 20 PD and less than 50 PD received no treatment from the start of the First Treatment Period (FTP). Par were re-evaluated at Week 4 and Weeks 12-24. Par who did not meet the injection criteria at any time point remained in the FTP group and were observed up to study Week 52.
195175|NCT01584648|B3|Baseline|Total|Total of all reporting groups
195176|NCT01584648|B2|Baseline|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195177|NCT01584648|B1|Baseline|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195178|NCT01584648|P2|Participant Flow|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195179|NCT01584648|P1|Participant Flow|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195180|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195181|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195182|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195183|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195184|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195185|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195186|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195187|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195188|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195189|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195190|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195191|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195362|NCT01583530|O1|Outcome|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
195213|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195214|NCT01584648|E2|Reported Event|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195215|NCT01584648|E1|Reported Event|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
195216|NCT01584544|B6|Baseline|Total|Total of all reporting groups
195217|NCT01584544|B5|Baseline|1650mg|"capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
195218|NCT01584544|B4|Baseline|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
195219|NCT01584544|B3|Baseline|1350mg|"capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
195220|NCT01584544|B2|Baseline|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
195221|NCT01584544|B1|Baseline|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.~capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
195222|NCT01584544|P5|Participant Flow|1650mg|"capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
195223|NCT01584544|P4|Participant Flow|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
195224|NCT01584544|P3|Participant Flow|1350mg|"capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
195225|NCT01584544|P2|Participant Flow|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
195226|NCT01584544|P1|Participant Flow|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.~capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
195227|NCT01584544|O5|Outcome|1650mg|"capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
195228|NCT01584544|O4|Outcome|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
195229|NCT01584544|O3|Outcome|1350mg|"capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
195230|NCT01584544|O2|Outcome|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
195231|NCT01584544|O1|Outcome|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.~capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
195232|NCT01584544|E5|Reported Event|1650mg|"capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
195233|NCT01584544|E4|Reported Event|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
195234|NCT01584544|E3|Reported Event|1350mg|"capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
195235|NCT01584544|E2|Reported Event|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
195236|NCT01584544|E1|Reported Event|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.~capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
195237|NCT01584518|B3|Baseline|Total|Total of all reporting groups
195238|NCT01584518|B2|Baseline|Non CHF Peptide|Diuresis based on clinical judgement without data for CHF-P
195239|NCT01584518|B1|Baseline|CHF Peptide|"Diuresis based on CHF-P~Furosemide: Based on clinical standard per clinician"
195240|NCT01584518|P2|Participant Flow|Non CHF Peptide|Diuresis based on clinical judgement without data for CHF-P
195241|NCT01584518|P1|Participant Flow|CHF Peptide|"Diuresis based on CHF-P~Furosemide: Based on clinical standard per clinician"
195251|NCT01584479|P4|Participant Flow|High Risk Control Group|"2 visits - High Risk 1,847 evaluable subjects~High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
195252|NCT01584479|P3|Participant Flow|High Risk Experimental Group|"1 visit - High Risk 852 evaluable subjects~High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
195253|NCT01584479|P2|Participant Flow|Low Risk Control Group|"2 visits - Low Risk 1,668 evaluable subjects~- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
195254|NCT01584479|P1|Participant Flow|Low Risk Experimental Group|"1 visit - Low Risk 732 evaluable subjects~- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
195255|NCT01584479|O4|Outcome|High Risk Control Group|"2 visits - High Risk~~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
195256|NCT01584479|O3|Outcome|High Risk Experimental Group|"1 visit - High Risk~~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
195257|NCT01584479|O2|Outcome|Low Risk Control Group|"2 visits - Low Risk~~1200 subjects~- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
195258|NCT01584479|O1|Outcome|Low Risk Experimental Group|"1 visit - Low Risk~~1200 subjects~- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
195259|NCT01584479|E4|Reported Event|High Risk Control Group|"2 visits - High Risk~~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
195260|NCT01584479|E3|Reported Event|High Risk Experimental Group|"1 visit - High Risk~~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
195261|NCT01584479|E2|Reported Event|Low Risk Control Group|"2 visits - Low Risk~~1200 subjects~- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
195262|NCT01584479|E1|Reported Event|Low Risk Experimental Group|"1 visit - Low Risk~~1200 subjects~- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
195263|NCT01584388|B1|Baseline|Rituximab|Rituximab: Rituximab 1000 mg IV times two doses, separated by approximately 15 days.
195264|NCT01584388|P1|Participant Flow|Rituximab|Rituximab: Rituximab 1000 mg IV times two doses, separated by approximately 15 days.
195265|NCT01584388|O1|Outcome|Time to Complete Remission|Time to achievement of IgG4-RD RI of 0
195266|NCT01584388|O1|Outcome|Time to Relapse|Time to increase in IgG4-RD RI and reinstitution of treatment
195267|NCT01584388|O1|Outcome|Time to Disease Response|Time to achievement of IgG4-RD RI improvement of > 2
195268|NCT01584388|O1|Outcome|Complete Remission at Any Timepoint, Exclusive of Serum IgG4|IgG4-RD RI = 0 (exclusive of serum IgG4) at any point in the trial
195269|NCT01584388|O1|Outcome|Complete Remission (Any Timepoint)|IgG4-RD RI = 0 at any point in the trial
195270|NCT01584388|O1|Outcome|Complete Remission at 6 Months, Exclusive of Serum IgG4|IgG-RD RI (exclusive of serum IgG4) of 0 at 6 months.
195271|NCT01584388|O1|Outcome|Complete Remission at 6 Months|IgG-RD RI (exclusive of serum IgG4) of 0 at 6 months.
195272|NCT01584388|O1|Outcome|Disease Response at 12 Months|Decline of IgG4-RD RI by at least 2 points and maintained at 12 months.
195273|NCT01584388|O1|Outcome|Disease Response at 6 Months|Decline of IgG4-RD RI by at least 2 points and maintained at 6 months.
195274|NCT01584388|O1|Outcome|Relapse Treatment|Rituximab treatment for relapse
195275|NCT01584388|O1|Outcome|Disease Flare|no disease flare before month 6
195276|NCT01584388|O2|Outcome|Glucocorticoid Use (6 Months)|total prednisone dose equivalent admin over 28 days prior to the 6 month study visit
195277|NCT01584388|O1|Outcome|Glucocorticoid Treatment (Baseline)|total prednisone dose equivalent (mg) admin in the 28 preceding enrollment)
195278|NCT01584388|O2|Outcome|6 Months|IgG4-RD Responder Index 6 months after treatment
195279|NCT01584388|O1|Outcome|IgG4-RD Responder Index|Scoring at baseline
195280|NCT01584388|E1|Reported Event|Open Label Treatment With Rituximab|Rituximab 1000 mg IV times two doses, separated by approximately 15 days
195281|NCT01584232|B3|Baseline|Total|Total of all reporting groups
195282|NCT01584232|B2|Baseline|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
195283|NCT01584232|B1|Baseline|LY2189265 + OAM|"LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
195284|NCT01584232|P2|Participant Flow|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
195285|NCT01584232|P1|Participant Flow|LY2189265 + OAM|"LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
195308|NCT01583647|O1|Outcome|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
195286|NCT01584232|O2|Outcome|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
195287|NCT01584232|O1|Outcome|LY2189265 + OAM|"LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
195288|NCT01584232|O2|Outcome|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
195289|NCT01584232|O1|Outcome|LY2189265 + OAM|"LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
195290|NCT01584232|O2|Outcome|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
195291|NCT01584232|O1|Outcome|LY2189265 + OAM|"LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
195292|NCT01584232|O2|Outcome|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
195293|NCT01584232|O1|Outcome|LY2189265 + OAM|"LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
195294|NCT01584232|O2|Outcome|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
195295|NCT01584232|O1|Outcome|LY2189265 + OAM|"LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
195296|NCT01584232|O2|Outcome|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
195297|NCT01584232|O1|Outcome|LY2189265 + OAM|"LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
195298|NCT01584232|E2|Reported Event|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
195299|NCT01584232|E1|Reported Event|LY2189265 + OAM|"LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
195300|NCT01583894|B1|Baseline|Chronic Pain Patients|Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months
195301|NCT01583894|P1|Participant Flow|Chronic Pain Patients|Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months
195302|NCT01583894|O1|Outcome|Chronic Pain Patients|Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months
195303|NCT01583894|E1|Reported Event|Chronic Pain Patients|Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months
195304|NCT01583647|B1|Baseline|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
195305|NCT01583647|P2|Participant Flow|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
195306|NCT01583647|P1|Participant Flow|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
195311|NCT01583647|O2|Outcome|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
195312|NCT01583647|O1|Outcome|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
195313|NCT01583647|O2|Outcome|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
195314|NCT01583647|O1|Outcome|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
195315|NCT01583647|E2|Reported Event|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
195316|NCT01583647|E1|Reported Event|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
195317|NCT01583543|B1|Baseline|Olaparib|Patients with metastatic Ewing sarcoma who had previously received at least one line of chemotherapy were enrolled.
195318|NCT01583543|P1|Participant Flow|Olaparib|Patients with metastatic Ewing sarcoma who had previously received at least one line of chemotherapy were enrolled.
195319|NCT01583543|O1|Outcome|Olaparib|"400mg PO BID Continuous~Olaparib: 400mg PO BID Continuous"
195320|NCT01583543|O1|Outcome|Olaparib|This group of patients with metastatic Ewing sarcoma received single agent olaparib therapy.
195321|NCT01583543|O1|Outcome|Olaparib|This group of patients with metastatic Ewing sarcoma received single agent olaparib.
195322|NCT01583543|O1|Outcome|Olaparib|Patients with metastatic Ewing sarcoma who had previously received at least one line of chemotherapy were enrolled.
195323|NCT01583543|E1|Reported Event|Olaparib|400 mg PO BID Continuous Olaparib
195324|NCT01583530|B7|Baseline|Total|Total of all reporting groups
195325|NCT01583530|B6|Baseline|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
195326|NCT01583530|B5|Baseline|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
195327|NCT01583530|B4|Baseline|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
195328|NCT01583530|B3|Baseline|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
195329|NCT01583530|B2|Baseline|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
195330|NCT01583530|B1|Baseline|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
195331|NCT01583530|P6|Participant Flow|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
195332|NCT01583530|P5|Participant Flow|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
195333|NCT01583530|P4|Participant Flow|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
195334|NCT01583530|P3|Participant Flow|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
195335|NCT01583530|P2|Participant Flow|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
195336|NCT01583530|P1|Participant Flow|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
195337|NCT01583530|O6|Outcome|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
195338|NCT01583530|O5|Outcome|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
195339|NCT01583530|O4|Outcome|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
195340|NCT01583530|O3|Outcome|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
195341|NCT01583530|O2|Outcome|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
195342|NCT01583530|O1|Outcome|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
195343|NCT01583530|O2|Outcome|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
195344|NCT01583530|O1|Outcome|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
195345|NCT01583530|O2|Outcome|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
195346|NCT01583530|O1|Outcome|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
195347|NCT01583530|O2|Outcome|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
195348|NCT01583530|O1|Outcome|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
195349|NCT01583530|O2|Outcome|Belimumab SC x 1 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
195350|NCT01583530|O1|Outcome|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
195351|NCT01583530|O4|Outcome|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
195352|NCT01583530|O3|Outcome|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
195353|NCT01583530|O2|Outcome|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
195354|NCT01583530|O1|Outcome|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
195355|NCT01583530|O4|Outcome|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
195356|NCT01583530|O3|Outcome|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
195357|NCT01583530|O2|Outcome|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
195358|NCT01583530|O1|Outcome|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
195359|NCT01583530|O4|Outcome|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
195360|NCT01583530|O3|Outcome|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
195364|NCT01583530|O3|Outcome|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
195365|NCT01583530|O2|Outcome|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
195366|NCT01583530|O1|Outcome|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
195367|NCT01583530|O2|Outcome|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
195368|NCT01583530|O1|Outcome|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
195369|NCT01583530|O4|Outcome|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
195370|NCT01583530|O3|Outcome|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
195371|NCT01583530|O2|Outcome|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
195372|NCT01583530|O1|Outcome|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
195373|NCT01583530|E6|Reported Event|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
195374|NCT01583530|E5|Reported Event|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
195375|NCT01583530|E4|Reported Event|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
195376|NCT01583530|E3|Reported Event|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
195377|NCT01583530|E2|Reported Event|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
195378|NCT01583530|E1|Reported Event|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
195379|NCT01583452|B3|Baseline|Total|Total of all reporting groups
195380|NCT01583452|B2|Baseline|No Intervention|By observing the clinical evolution of the participants not given chewing gum as prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
195381|NCT01583452|B1|Baseline|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, besides the standard pharmacologic treatment and post-operative care.~Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
195382|NCT01583452|P2|Participant Flow|No Intervention|By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
195383|NCT01583452|P1|Participant Flow|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, plus the standard pharmacologic treatment and post-operative care.~Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
195384|NCT01583452|O2|Outcome|No Intervention|By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
195385|NCT01583452|O1|Outcome|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, plus the standard pharmacologic treatment and post-operative care.~Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
195386|NCT01583452|O2|Outcome|No Intervention|By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
195387|NCT01583452|O1|Outcome|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, besides the standard pharmacologic treatment and post-operative care.~Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
195388|NCT01583452|O2|Outcome|No Intervention|By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
195389|NCT01583452|O1|Outcome|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, plus the standard pharmacologic treatment and post-operative care.~Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
195390|NCT01583452|O2|Outcome|Control Group|The time between the end of surgery and the discharge of the patient measured in hours.
195391|NCT01583452|O1|Outcome|Chewing Gum Group|The time between the end of the surgery and the discharge of the patients, measured in hours.
195392|NCT01583452|E2|Reported Event|No Intervention|By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
195393|NCT01583452|E1|Reported Event|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, plus the standard pharmacologic treatment and post-operative care.~Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
195394|NCT01583374|B4|Baseline|Total|Total of all reporting groups
195395|NCT01583374|B3|Baseline|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast PO BID in the 24-week placebo-controlled treatment phase.
195396|NCT01583374|B2|Baseline|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast PO BID in the 24-week placebo-controlled treatment phase.
195397|NCT01583374|B1|Baseline|Placebo|Participants initially randomized to placebo by mouth (PO) twice daily (BID) in the 24-week placebo-controlled treatment phase.
195398|NCT01583374|P3|Participant Flow|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast PO BID in the 24-week placebo-controlled treatment phase.
195399|NCT01583374|P2|Participant Flow|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast PO BID in the 24-week placebo-controlled treatment phase.
195400|NCT01583374|P1|Participant Flow|Placebo|Participants initially randomized to placebo by mouth (PO) twice daily (BID) in the 24-week placebo-controlled treatment phase.
195401|NCT01583374|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast PO BID in the 24-week placebo-controlled treatment phase..
195646|NCT01582282|P2|Participant Flow|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
195402|NCT01583374|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast PO BID in the 24-week placebo-controlled treatment phase.
195403|NCT01583374|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
195404|NCT01583374|O2|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast PO BID in the 24-week placebo-controlled treatment phase.
195405|NCT01583374|O1|Outcome|Placebo|Participants initially randomized to placebo by mouth (PO) twice daily (BID) in the 24-week placebo-controlled treatment phase.
195406|NCT01583374|E3|Reported Event|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 24-week placebo controlled treatment phase.
195407|NCT01583374|E2|Reported Event|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo controlled treatment phase.
195408|NCT01583374|E1|Reported Event|Placebo|Participants initially randomized to receive placebo tablets twice daily.
195409|NCT01583218|B3|Baseline|Total|Total of all reporting groups
195410|NCT01583218|B2|Baseline|Enoxaparin|Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days
195411|NCT01583218|B1|Baseline|Betrixaban|Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days
195412|NCT01583218|P2|Participant Flow|Enoxaparin|Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days
195413|NCT01583218|P1|Participant Flow|Betrixaban|Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days
195414|NCT01583218|O2|Outcome|Enoxaparin|Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days
195415|NCT01583218|O1|Outcome|Betrixaban|Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days
195416|NCT01583218|O2|Outcome|Enoxaparin|Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days
195417|NCT01583218|O1|Outcome|Betrixaban|Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days
195418|NCT01583218|O2|Outcome|Enoxaparin|Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days
195419|NCT01583218|O1|Outcome|Betrixaban|Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days
195420|NCT01583218|O2|Outcome|Enoxaparin|Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days
195421|NCT01583218|O1|Outcome|Betrixaban|Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days
195422|NCT01583218|O2|Outcome|Enoxaparin|Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days
195423|NCT01583218|O1|Outcome|Betrixaban|Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days
195424|NCT01583218|O2|Outcome|Enoxaparin|Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days
195425|NCT01583218|O1|Outcome|Betrixaban|Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days
195426|NCT01583218|O2|Outcome|Enoxaparin|Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days
195427|NCT01583218|O1|Outcome|Betrixaban|Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days
195428|NCT01583218|E2|Reported Event|Enoxaparin|Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days
195429|NCT01583218|E1|Reported Event|Betrixaban|Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days
195430|NCT01583101|B3|Baseline|Total|Total of all reporting groups
195431|NCT01583101|B2|Baseline|Receiving Non-highlighted Prompts|These patients received prompts that were not highlighted.
195432|NCT01583101|B1|Baseline|Receiving Highlighted Prompts|These patients received highlighted prompts.
195433|NCT01583101|P2|Participant Flow|Non-highlighted Prompts|Physicians received prompts that were not highlighted.
195434|NCT01583101|P1|Participant Flow|Highlighted Prompts|Physicians received highlighted prompts.
195435|NCT01583101|O2|Outcome|Receiving Non-highlighted Prompts|Prompts received by physicians were not highlighted.
195436|NCT01583101|O1|Outcome|Receiving Highlighted Prompts|Prompts received by physicians were highlighted.
195437|NCT01583101|E2|Reported Event|Non-highlighted Prompts|These patients received prompts that were not highlighted.
195438|NCT01583101|E1|Reported Event|Highlighted Prompts|These patients received highlighted prompts.
195439|NCT01582971|B3|Baseline|Total|Total of all reporting groups
195440|NCT01582971|B2|Baseline|Control|Standard medical care: no reflexology.
195441|NCT01582971|B1|Baseline|Intervention|"Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member.~Friend/family member was trained in foot reflexology protocol by certified reflexologist.~Friend/family member provides 4 weekly sessions to patient."
195442|NCT01582971|P2|Participant Flow|Control|Standard medical care: no reflexology.
195443|NCT01582971|P1|Participant Flow|Intervention|"Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member.~Friend/family member was trained in foot reflexology protocol by certified reflexologist.~Friend/family member provides 4 weekly sessions to patient."
195444|NCT01582971|O2|Outcome|Control|Standard medical care: no reflexology.
195445|NCT01582971|O1|Outcome|Intervention|"Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member.~Friend/family member was trained in foot reflexology protocol by certified reflexologist.~Friend/family member provides 4 weekly sessions to patient."
195446|NCT01582971|O4|Outcome|Week 11 Control Group|Standard medical care: no reflexology.
203395|NCT01553318|O1|Outcome|Ketotifen|active drug group
195447|NCT01582971|O3|Outcome|Week 11 Intervention Group|"Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member.~Friend/family member was trained in foot reflexology protocol by certified reflexologist.~Friend/family member provides 4 weekly sessions to patient."
195448|NCT01582971|O2|Outcome|Week 5 Control Group|Standard medical care: no reflexology.
195449|NCT01582971|O1|Outcome|Week 5 Intervention Group|"Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member.~Friend/family member was trained in foot reflexology protocol by certified reflexologist.~Friend/family member provides 4 weekly sessions to patient."
195450|NCT01582971|O4|Outcome|Week 11 Control Group|Standard medical care: no reflexology.
195451|NCT01582971|O3|Outcome|Week 11 Intervention Group|"Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member.~Friend/family member was trained in foot reflexology protocol by certified reflexologist.~Friend/family member provides 4 weekly sessions to patient."
195452|NCT01582971|O2|Outcome|Week 5 Control Group|Standard medical care: no reflexology.
195453|NCT01582971|O1|Outcome|Week 5 Intervention Group|"Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member.~Friend/family member was trained in foot reflexology protocol by certified reflexologist.~Friend/family member provides 4 weekly sessions to patient."
195454|NCT01582971|O4|Outcome|Week 11 Control Group|Standard medical care: no reflexology
195455|NCT01582971|O3|Outcome|Week 11 Intervention Group|"Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member.~Friend/family member was trained in foot reflexology protocol by certified reflexologist.~Friend/family member provides 4 weekly sessions to patient."
195456|NCT01582971|O2|Outcome|Week 5 Control Group|Standard medical care: no reflexology
195457|NCT01582971|O1|Outcome|Week 5 Intervention Group|"Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member.~Friend/family member was trained in foot reflexology protocol by certified reflexologist.~Friend/family member provides 4 weekly sessions to patient."
195458|NCT01582971|E2|Reported Event|Control|Standard medical care: no reflexology
195459|NCT01582971|E1|Reported Event|Intervention|"Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member.~Friend/family member was trained in foot reflexology protocol by certified reflexologist.~Friend/family member provides 4 weekly sessions to patient."
195460|NCT01582945|B1|Baseline|Treatment-resistant Depression Patients|Outpatient sample of patients (18-65 years old) with treatment-resistant major depressive disorder (TRD).
195461|NCT01582945|P1|Participant Flow|Treatment-resistant Depression Patients|Outpatient sample of patients (18-65 years old) with treatment-resistant major depressive disorder (TRD).
195462|NCT01582945|O1|Outcome|Ketamine IV|"Patients will receive open label augmentation with IV Ketamine at 0.5mg/kg over the course of 45 minutes, twice a week for 3 weeks. Participants received this dosage for the first three of six IV ketamine infusions. If participants do not experience an improvement of greater or equal to 30% in HAM-D scores after the first three infusions, the dose will be increased to 0.75mg/kg for the subsequent three infusions.~Ketamine: Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen"
195463|NCT01582945|E1|Reported Event|Ketamine IV|"Patients will receive open label augmentation with IV Ketamine at 0.5mg/kg, twice a week for 3 weeks~Ketamine: Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen"
195464|NCT01582880|B1|Baseline|Riboflavin Cross-linked Donor Cornea|"the donor cornea used as a carrier for the Boston Keratoprosthesis will undergo crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.~Riboflavin: Used to treat donor cornea before implantation"
195465|NCT01582880|P1|Participant Flow|Riboflavin Cross-linked Donor Cornea|"the donor cornea used as a carrier for the Boston Keratoprosthesis will undergo crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.~Riboflavin: Used to treat donor cornea before implantation"
195466|NCT01582880|O1|Outcome|Riboflavin Cross-linked Donor Cornea|"The donor cornea used as a carrier for the Boston Keratoprosthesis underwent crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.~Riboflavin: Used to treat donor cornea before implantation"
195467|NCT01582880|O1|Outcome|Riboflavin Cross-linked Donor Cornea|"The donor cornea used as a carrier for the Boston Keratoprosthesis underwent crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.~Riboflavin: Used to treat donor cornea before implantation"
195468|NCT01582880|O1|Outcome|Riboflavin Cross-linked Donor Cornea|"The donor cornea used as a carrier for the Boston Keratoprosthesis underwent crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.~Riboflavin: Used to treat donor cornea before implantation"
195469|NCT01582880|O1|Outcome|Riboflavin Cross-linked Donor Cornea|"The donor cornea used as a carrier for the Boston Keratoprosthesis underwent crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.~Riboflavin: Used to treat donor cornea before implantation"
195470|NCT01582880|O1|Outcome|Riboflavin Cross-linked Donor Cornea|"The donor cornea used as a carrier for the Boston Keratoprosthesis underwent crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.~Riboflavin: Used to treat donor cornea before implantation"
195471|NCT01582880|E1|Reported Event|Riboflavin Cross-linked Donor Cornea|"The donor cornea used as a carrier for the Boston Keratoprosthesis underwent crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.~Riboflavin: Used to treat donor cornea before implantation"
195472|NCT01582854|B3|Baseline|Total|Total of all reporting groups
195473|NCT01582854|B2|Baseline|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
195474|NCT01582854|B1|Baseline|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
195475|NCT01582854|P2|Participant Flow|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
195476|NCT01582854|P1|Participant Flow|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
195477|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
195478|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
195479|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
195480|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
195481|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
195482|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
195483|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
195484|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
195485|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
195486|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
195487|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
195488|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
195489|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
195490|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
195491|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
195492|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
195493|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
195494|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
195495|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
195496|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
195497|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
195498|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
195499|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
195500|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
195501|NCT01582854|E2|Reported Event|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
195502|NCT01582854|E1|Reported Event|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
195503|NCT01582789|B1|Baseline|Overall Study Group Prior to Dispense|All subjects prior to dispense of first set of study lenses
195504|NCT01582789|P2|Participant Flow|Senofilcon A, Then Enfilcon A|"senofilcon A daily wear soft contact lens 1st then cross over and subject wears the enfilcon A daily wear soft contact lens 2nd~enfilcon A: enfilcon A daily wear soft contact lens~senofilcon A: senofilcon A daily wear soft contact lens"
195505|NCT01582789|P1|Participant Flow|Enfilcon A, Then Senofilcon A|"enfilcon A daily wear soft contact lens 1st then cross over and subject wears the senofilcon A daily wear soft contact lens 2nd~enfilcon A: enfilcon A daily wear soft contact lens~senofilcon A: senofilcon A daily wear soft contact lens"
195506|NCT01582789|O2|Outcome|Senofilcon A|Subject wears senofilcon A daily wear soft contact lens as second pair
195507|NCT01582789|O1|Outcome|Enfilcon A|Subject wears enfilcon A daily wear soft contact lens as second pair
195508|NCT01582789|O2|Outcome|Senofilcon A|Subject wears senofilcon A daily wear soft contact lens as first pair
195509|NCT01582789|O1|Outcome|Enfilcon A|Subject wears enfilcon A daily wear soft contact lens as first pair
195510|NCT01582789|O2|Outcome|Senofilcon A|Subject wears senofilcon A daily wear soft contact lens as second pair
195511|NCT01582789|O1|Outcome|Enfilcon A|Subject wears enfilcon A daily wear soft contact lens as second pair
195512|NCT01582789|O2|Outcome|Senofilcon A|Subject wears senofilcon A daily wear soft contact lens as first pair
195513|NCT01582789|O1|Outcome|Enfilcon A|Subject wears enfilcon A daily wear soft contact lens as first pair
195514|NCT01582789|O2|Outcome|Senofilcon A|Subject wears senofilcon A daily wear soft contact lens as second pair
195515|NCT01582789|O1|Outcome|Enfilcon A|Subject wears enfilcon A daily wear soft contact lens as second pair
195516|NCT01582789|O2|Outcome|Senofilcon A|Subject wears senofilcon A daily wear soft contact lens as first pair
195517|NCT01582789|O1|Outcome|Enfilcon A|Subject wears enfilcon A daily wear soft contact lens as first pair
195518|NCT01582789|E2|Reported Event|Senofilcon A/Enfilcon A|"senofilcon A daily wear soft contact lens 1st then cross over and subject wears the enfilcon A daily wear soft contact lens 2nd~enfilcon A: enfilcon A daily wear soft contact lens~senofilcon A: senofilcon A daily wear soft contact lens"
195519|NCT01582789|E1|Reported Event|Enfilcon A/Senofilcon A|"enfilcon A daily wear soft contact lens 1st then cross over and subject wears the senofilcon A daily wear soft contact lens 2nd~enfilcon A: enfilcon A daily wear soft contact lens~senofilcon A: senofilcon A daily wear soft contact lens"
195520|NCT01582490|B3|Baseline|Total|Total of all reporting groups
195521|NCT01582490|B2|Baseline|Instillation - EXPAREL|"Group 1 will receive diluted EXPAREL (i.e., the contents of one 20 mL vial, 266 mg, diluted with 20 mL of preservative-free 0.9% normal saline to a total of 40 mL) for postsurgical analgesia. Half of the resulting mixture (i.e., 20 mL) will be instilled into each breast pocket at the beginning of surgery.~Infiltration - EXPAREL: IV morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed."
195522|NCT01582490|B1|Baseline|Infiltration - EXPAREL|"Group 2 will receive diluted EXPAREL (i.e., the contents of one 20 mL vial, 266 mg, diluted with 20 mL of preservative-free 0.9% normal saline to a total of 40 mL) for postsurgical analgesia. Half of the resulting mixture (i.e., 20 mL) will be administered via local infiltration into each surgical site per the surgeon's normal practice at the beginning of surgery.~Instillation - EXPAREL: Intravenous (IV) morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed."
195523|NCT01582490|P2|Participant Flow|Instillation - EXPAREL|Subjects received EXPAREL 266 mg via instillation.
195524|NCT01582490|P1|Participant Flow|Infiltration - EXPAREL|Subjects received EXPAREL 266 mg via infiltration.
195525|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
195526|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
195527|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
195528|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
195529|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
195530|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
195531|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
195532|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
195533|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
195534|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
195535|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
195536|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
195537|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received EXPAREL 266 mg via instillation.
195538|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received EXPAREL 266 mg via infiltration.
195539|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received EXPAREL 266 mg via instillation.
195540|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received EXPAREL 266 mg via infiltration.
195541|NCT01582490|E2|Reported Event|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
195542|NCT01582490|E1|Reported Event|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
195543|NCT01582477|B3|Baseline|Total|Total of all reporting groups
195544|NCT01582477|B2|Baseline|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
195545|NCT01582477|B1|Baseline|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
195546|NCT01582477|P2|Participant Flow|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
195547|NCT01582477|P1|Participant Flow|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
195548|NCT01582477|O2|Outcome|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
195549|NCT01582477|O1|Outcome|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
195550|NCT01582477|O2|Outcome|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
195551|NCT01582477|O1|Outcome|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
195552|NCT01582477|O2|Outcome|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
195553|NCT01582477|O1|Outcome|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
195554|NCT01582477|O2|Outcome|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
195555|NCT01582477|O1|Outcome|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
195556|NCT01582477|O2|Outcome|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
195557|NCT01582477|O1|Outcome|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
195558|NCT01582477|O2|Outcome|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
195559|NCT01582477|O1|Outcome|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
195560|NCT01582477|E2|Reported Event|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
195561|NCT01582477|E1|Reported Event|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
195562|NCT01582451|B3|Baseline|Total|Total of all reporting groups
195563|NCT01582451|B2|Baseline|Insulin Glargine|Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195564|NCT01582451|B1|Baseline|LY2605541|LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195565|NCT01582451|P2|Participant Flow|Insulin Glargine|Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195645|NCT01582282|P3|Participant Flow|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
195566|NCT01582451|P1|Participant Flow|LY2605541|LY2605541 was administered by subcutaneous (SQ) injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on fasting blood glucose (FBG).
195567|NCT01582451|O2|Outcome|Insulin Glargine|Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195568|NCT01582451|O1|Outcome|LY2605541|LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195569|NCT01582451|O2|Outcome|Insulin Glargine|Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195570|NCT01582451|O1|Outcome|LY2605541|LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195571|NCT01582451|O2|Outcome|Insulin Glargine|Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195572|NCT01582451|O1|Outcome|LY2605541|LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195573|NCT01582451|O2|Outcome|Insulin Glargine|Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195574|NCT01582451|O1|Outcome|LY2605541|LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195575|NCT01582451|O2|Outcome|Insulin Glargine|Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195576|NCT01582451|O1|Outcome|LY2605541|LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195577|NCT01582451|O2|Outcome|Insulin Glargine|Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195578|NCT01582451|O1|Outcome|LY2605541|LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195579|NCT01582451|O2|Outcome|Insulin Glargine|Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195580|NCT01582451|O1|Outcome|LY2605541|LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195581|NCT01582451|O2|Outcome|Insulin Glargine|Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195582|NCT01582451|O1|Outcome|LY2605541|LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195583|NCT01582451|O2|Outcome|Insulin Glargine|Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195584|NCT01582451|O1|Outcome|LY2605541|LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195585|NCT01582451|O2|Outcome|Insulin Glargine|Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195586|NCT01582451|O1|Outcome|LY2605541|LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195587|NCT01582451|O2|Outcome|Insulin Glargine|Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195588|NCT01582451|O1|Outcome|LY2605541|LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195589|NCT01582451|O2|Outcome|Insulin Glargine|Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195590|NCT01582451|O1|Outcome|LY2605541|LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195591|NCT01582451|O2|Outcome|Insulin Glargine|Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195592|NCT01582451|O1|Outcome|LY2605541|LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195593|NCT01582451|O2|Outcome|Insulin Glargine|Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195594|NCT01582451|O1|Outcome|LY2605541|LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195595|NCT01582451|O2|Outcome|Insulin Glargine|Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195596|NCT01582451|O1|Outcome|LY2605541|LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195597|NCT01582451|O2|Outcome|Insulin Glargine|Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195598|NCT01582451|O1|Outcome|LY2605541|LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195599|NCT01582451|O2|Outcome|Insulin Glargine|Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195600|NCT01582451|O1|Outcome|LY2605541|LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195601|NCT01582451|O2|Outcome|Insulin Glargine|Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195602|NCT01582451|O1|Outcome|LY2605541|LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195603|NCT01582451|O2|Outcome|Insulin Glargine|Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195604|NCT01582451|O1|Outcome|LY2605541|LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195605|NCT01582451|E2|Reported Event|Insulin Glargine|Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195606|NCT01582451|E1|Reported Event|LY2605541|LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
195607|NCT01582308|B1|Baseline|All Enrolled Participants|
195608|NCT01582308|P10|Participant Flow|Treatment Sequence 10|Placebo in Period 1 followed by saxagliptin 5 mg in Period 2 followed by sitagliptin 100 mg in Period 3 followed by vildagliptin 50 mg BID in Period 4 followed by vildagliptin 50 mg in Period 5
195609|NCT01582308|P9|Participant Flow|Treatment Sequence 9|Vildagliptin 50 mg BID in Period 1 followed by sitagliptin 100 mg in Period 2 followed by placebo in Period 3 followed by vildagliptin 50 mg in Period 4 followed by saxagliptin 5 mg in Period 5
195610|NCT01582308|P8|Participant Flow|Treatment Sequence 8|Vildagliptin 50 mg in Period 1 followed by placebo in Period 2 followed by vildagliptin 50 mg BID in Period 3 followed by saxagliptin 5 mg in Period 4 followed by sitagliptin 100 mg in Period 5
195611|NCT01582308|P7|Participant Flow|Treatment Sequence 7|Saxagliptin 5 mg in Period 1 followed by vildagliptin 50 mg BID in Period 2 followed by vildagliptin 50 mg in Period 3 followed by sitagliptin 100 mg in Period 4 followed by placebo in Period 5
195612|NCT01582308|P6|Participant Flow|Treatment Sequence 6|Sitagliptin 100 mg in Period 1 followed by vildagliptin 50 mg in Period 2 followed by saxagliptin 5 mg in Period 3 followed by placebo in Period 4 followed by vildagliptin 50 mg BID in Period 5
195613|NCT01582308|P5|Participant Flow|Treatment Sequence 5|Placebo in Period 1 followed by sitagliptin 100 mg in Period 2 followed by vildagliptin 50 mg in Period 3 followed by vildagliptin 50 mg BID in Period 4 followed by saxagliptin 5 mg in Period 5
195614|NCT01582308|P4|Participant Flow|Treatment Sequence 4|Vildagliptin 50 mg BID in Period 1 followed by placebo in Period 2 followed by saxagliptin 5 mg in Period 3 followed by vildagliptin 50 mg in Period 4 followed by sitagliptin 100 mg in Period 5
195615|NCT01582308|P3|Participant Flow|Treatment Sequence 3|Vildagliptin 50 mg in Period 1 followed by vildagliptin 50 mg BID in Period 2 followed by sitagliptin 100 mg in Period 3 followed by saxagliptin 5 mg in Period 4 followed by placebo in Period 5
195616|NCT01582308|P2|Participant Flow|Treatment Sequence 2|Saxagliptin 5 mg in Period 1 followed by vildagliptin 50 mg in Period 2 followed by placebo in Period 3 followed by sitagliptin 100 mg in Period 4 followed by vildagliptin 50 mg BID in Period 5
195617|NCT01582308|P1|Participant Flow|Treatment Sequence 1|Sitagliptin 100 mg in Period 1 followed by saxagliptin 5 mg in Period 2 followed by vildagliptin 50 mg BID in Period 3 followed by placebo in Period 4 followed by vildagliptin 50 mg in Period 5
195618|NCT01582308|O4|Outcome|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
195619|NCT01582308|O3|Outcome|Vildagliptin 50 mg|Vildagliptin 50 mg daily for 5 days
195620|NCT01582308|O2|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg daily for 5 days
195621|NCT01582308|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg daily for 5 days
195622|NCT01582308|O4|Outcome|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
195623|NCT01582308|O3|Outcome|Vildagliptin 50 mg|Vildagliptin 50 mg daily for 5 days
195624|NCT01582308|O2|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg daily for 5 days
195625|NCT01582308|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg daily for 5 days
195626|NCT01582308|O1|Outcome|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
195627|NCT01582308|O4|Outcome|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
195628|NCT01582308|O3|Outcome|Vildagliptin 50 mg|Vildagliptin 50 mg daily for 5 days
195629|NCT01582308|O2|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg daily for 5 days
195630|NCT01582308|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg daily for 5 days
195631|NCT01582308|O5|Outcome|Placebo|Placebo to sitagliptin daily for 5 days
195632|NCT01582308|O4|Outcome|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
195633|NCT01582308|O3|Outcome|Vildagliptin 50 mg|Vildagliptin 50 mg daily for 5 days
195634|NCT01582308|O2|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg daily for 5 days
195635|NCT01582308|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg daily for 5 days
195636|NCT01582308|E5|Reported Event|Placebo|Placebo to sitagliptin daily for 5 days
195637|NCT01582308|E4|Reported Event|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
195638|NCT01582308|E3|Reported Event|Vildagliptin 50 mg|Vildagliptin 50 mg daily for 5 days
195639|NCT01582308|E2|Reported Event|Saxagliptin 5 mg|Saxagliptin 5 mg daily for 5 days
195640|NCT01582308|E1|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg daily for 5 days
195641|NCT01582282|B4|Baseline|Total|Total of all reporting groups
195642|NCT01582282|B3|Baseline|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
195643|NCT01582282|B2|Baseline|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
195644|NCT01582282|B1|Baseline|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
195647|NCT01582282|P1|Participant Flow|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
195648|NCT01582282|O3|Outcome|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
195649|NCT01582282|O2|Outcome|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
195650|NCT01582282|O1|Outcome|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
195651|NCT01582282|O3|Outcome|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
195652|NCT01582282|O2|Outcome|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
195653|NCT01582282|O1|Outcome|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
195654|NCT01582282|O3|Outcome|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
195655|NCT01582282|O2|Outcome|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
195656|NCT01582282|O1|Outcome|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
195657|NCT01582282|O3|Outcome|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
195658|NCT01582282|O2|Outcome|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
195659|NCT01582282|O1|Outcome|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
195660|NCT01582282|O3|Outcome|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
195661|NCT01582282|O2|Outcome|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
195662|NCT01582282|O1|Outcome|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
195663|NCT01582282|O3|Outcome|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
195664|NCT01582282|O2|Outcome|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
195665|NCT01582282|O1|Outcome|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
195666|NCT01582282|E3|Reported Event|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
195667|NCT01582282|E2|Reported Event|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
195668|NCT01582282|E1|Reported Event|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
195669|NCT01582243|B1|Baseline|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
195670|NCT01582243|P1|Participant Flow|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
195671|NCT01582243|O1|Outcome|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
195672|NCT01582243|O1|Outcome|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
195673|NCT01582243|O1|Outcome|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
195674|NCT01582243|O1|Outcome|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
195675|NCT01582243|O1|Outcome|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
195676|NCT01582243|O1|Outcome|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
195677|NCT01582243|E1|Reported Event|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
195678|NCT01582178|B3|Baseline|Total|Total of all reporting groups
195679|NCT01582178|B2|Baseline|Cool Water Immersion Colonoscopy|Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
195680|NCT01582178|B1|Baseline|Warm Water Immersion Colonoscopy|Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
195681|NCT01582178|P2|Participant Flow|Cool Water Immersion Colonoscopy|Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
195682|NCT01582178|P1|Participant Flow|Warm Water Immersion Colonoscopy|Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
195683|NCT01582178|O2|Outcome|Cool Water Immersion Colonoscopy|Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
195684|NCT01582178|O1|Outcome|Warm Water Immersion Colonoscopy|Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
195685|NCT01582178|E2|Reported Event|Cool Water Immersion Colonoscopy|Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
195686|NCT01582178|E1|Reported Event|Warm Water Immersion Colonoscopy|Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
195687|NCT01582139|B3|Baseline|Total|Total of all reporting groups
195688|NCT01582139|B2|Baseline|Experimental First, Then Control|"Control, SSM+HMM: A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.~Experimental, Heart-Rate Informed SSM: An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate"
195689|NCT01582139|B1|Baseline|Control First, Then Experimental|"Control, SSM+HMM: A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.~Experimental, Heart-Rate Informed SSM: An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate"
198190|NCT01572792|O1|Outcome|Placebo|Placebo administered BID by inhalation
195690|NCT01582139|P2|Participant Flow|Experimental First, Then Control|"Control, SSM+HMM: A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.~Experimental, Heart-Rate Informed SSM: An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate"
195691|NCT01582139|P1|Participant Flow|Control First, Then Experimental|"Control, SSM+HMM: A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.~Experimental, Heart-Rate Informed SSM: An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate"
195692|NCT01582139|O2|Outcome|Control: SSM+HMM|A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
195693|NCT01582139|O1|Outcome|Experimental: Heart-Rate Informed SSM+HMM|"An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate~Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes."
195694|NCT01582139|O2|Outcome|Control: SSM+HMM|A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
195695|NCT01582139|O1|Outcome|Experimental: Heart-Rate Informed SSM+HMM|"An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate~Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes."
195696|NCT01582139|O2|Outcome|Control: SSM+HMM|A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
195697|NCT01582139|O1|Outcome|Experimental: Heart-Rate Informed SSM+HMM|"An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate~Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes."
195698|NCT01582139|O2|Outcome|Control: SSM+HMM|A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
195699|NCT01582139|O1|Outcome|Experimental: Heart-Rate Informed SSM+HMM|"An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate~Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes."
195700|NCT01582139|E2|Reported Event|Experimental: Heart Rate Informed SSM+HMM|"Experimental:~An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate~Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes."
195701|NCT01582139|E1|Reported Event|Control: SSM+HMM|A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
195702|NCT01582100|B1|Baseline|GERD Subjects With Nausea|Subjects who present with GERD along with nausea (with or without vomiting)
195703|NCT01582100|P1|Participant Flow|GERD Subjects With Nausea|Subjects who present with GERD along with nausea (with or without vomiting)
195704|NCT01582100|O1|Outcome|Single Arm Subjects With GERD/Nausea|This is a single arm study measuring the incidence and severity of nausea with or without vomiting in patients with GERD before and after treatment with Reletex
195705|NCT01582100|E1|Reported Event|Wrist Discomfort|subject did not like the feel of the device on wrist
195706|NCT01582009|B1|Baseline|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~panobinostat: Given orally~everolimus: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~liquid chromatography: Correlative studies~mass spectrometry: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~immunohistochemistry staining method: Correlative studies"
195707|NCT01582009|P1|Participant Flow|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~panobinostat: Given orally~everolimus: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~liquid chromatography: Correlative studies~mass spectrometry: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~immunohistochemistry staining method: Correlative studies"
195734|NCT01581710|O3|Outcome|2 Weeks After Montelukast Administration|Subjects will receive montelukast (4mg or 5mg) Each treatment period consists of 2 weeks
195735|NCT01581710|O2|Outcome|2 Weeks After Placebo Administration|Subjects will receive placebo. Each treatment period consists of 2 weeks
195736|NCT01581710|O1|Outcome|Baseline Lung Function|Before placebo or montelukast administration
195708|NCT01582009|O1|Outcome|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~panobinostat: Given orally~everolimus: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~liquid chromatography: Correlative studies~mass spectrometry: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~immunohistochemistry staining method: Correlative studies"
195709|NCT01582009|O1|Outcome|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~panobinostat: Given orally~everolimus: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~liquid chromatography: Correlative studies~mass spectrometry: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~immunohistochemistry staining method: Correlative studies"
195710|NCT01582009|O1|Outcome|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~panobinostat: Given orally~everolimus: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~liquid chromatography: Correlative studies~mass spectrometry: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~immunohistochemistry staining method: Correlative studies"
195711|NCT01582009|O1|Outcome|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~panobinostat: Given orally~everolimus: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~liquid chromatography: Correlative studies~mass spectrometry: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~immunohistochemistry staining method: Correlative studies"
195712|NCT01582009|O1|Outcome|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~panobinostat: Given orally~everolimus: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~liquid chromatography: Correlative studies~mass spectrometry: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~immunohistochemistry staining method: Correlative studies"
195713|NCT01582009|E1|Reported Event|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~panobinostat: Given orally~everolimus: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~liquid chromatography: Correlative studies~mass spectrometry: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~immunohistochemistry staining method: Correlative studies"
195714|NCT01581931|B1|Baseline|Overall Study|This was an open-label, randomised, single dose, 2-way crossover trial with 2 treatments and 2 treatment sequences. The single dose administrations in each treatment period were separated by a washout period of at least 35 days.
195715|NCT01581931|P2|Participant Flow|Lina+Met FDC Tablet / Lina+Met Single Tablets|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet in the first period. After a washout period of at least 35 days, the subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets in period 2.
195716|NCT01581931|P1|Participant Flow|Lina+Met Single Tablets / Lina+Met FDC Tablet|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets in the first period. After a washout period of at least 35 days, the subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet in period 2.
195717|NCT01581931|O2|Outcome|Lina+Met FDC Tablet|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet
195718|NCT01581931|O1|Outcome|Lina+Met Single Tablets|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets
195719|NCT01581931|O2|Outcome|Lina+Met FDC Tablet|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet
195720|NCT01581931|O1|Outcome|Lina+Met Single Tablets|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets
195721|NCT01581931|O2|Outcome|Lina+Met FDC Tablet|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet
195722|NCT01581931|O1|Outcome|Lina+Met Single Tablets|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets
195723|NCT01581931|O2|Outcome|Lina+Met FDC Tablet|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet
195724|NCT01581931|O1|Outcome|Lina+Met Single Tablets|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets
195725|NCT01581931|O2|Outcome|Lina+Met FDC Tablet|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet
195726|NCT01581931|O1|Outcome|Lina+Met Single Tablets|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets
195727|NCT01581931|E2|Reported Event|Lina+Met FDC Tablet|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet
195728|NCT01581931|E1|Reported Event|Lina+Met Single Tablets|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets
195729|NCT01581710|B1|Baseline|Subjects|All subjects
195730|NCT01581710|P2|Participant Flow|Placebo to Montelukast|Placebo to montelukast: Subjects will receive matching placebo. Each treatment period consists of 2 weeks
195731|NCT01581710|P1|Participant Flow|Montelukast to Placebo|Montelukast to placebo: Subjects will receive montelukast (4 mg or 5 mg) Each treatment period consists of 2 weeks
195732|NCT01581710|O2|Outcome|2 Weeks After Montelukast Administration|Subjects will receive montelukast (4mg or 5mg) Each treatment period consists of 2 weeks
195733|NCT01581710|O1|Outcome|2 Weeks After Placebo Administration|Subjects will receive placebo. Each treatment period consists of 2 weeks
198191|NCT01572792|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
195737|NCT01581710|O3|Outcome|2 Weeks After Montelukast Administration|Subjects will receive montelukast (4mg or 5mg) Each treatment period consists of 2 weeks
195738|NCT01581710|O2|Outcome|2 Weeks After Placebo Administration|Subjects will receive placebo. Each treatment period consists of 2 weeks
195739|NCT01581710|O1|Outcome|Baseline Lung Function|Before placebo or montelukast administration
195740|NCT01581710|O3|Outcome|2 Weeks After Montelukast Administration|Subjects will receive montelukast (4mg or 5mg) Each treatment period consists of 2 weeks
195741|NCT01581710|O2|Outcome|2 Weeks After Placebo Administration|Subjects will receive placebo. Each treatment period consists of 2 weeks
195742|NCT01581710|O1|Outcome|Baseline Lung Function|Before placebo or montelukast administration
195743|NCT01581710|O3|Outcome|2 Weeks After Montelukast Administration|Subjects will receive montelukast (4mg or 5mg) Each treatment period consists of 2 weeks
195744|NCT01581710|O2|Outcome|2 Weeks After Placebo Administration|Subjects will receive placebo. Each treatment period consists of 2 weeks
195745|NCT01581710|O1|Outcome|Baseline Lung Function|Before placebo or montelukast administration
195746|NCT01581710|O3|Outcome|2 Weeks After Montelukast Administration|Subjects will receive montelukast (4mg or 5mg) Each treatment period consists of 2 weeks
195747|NCT01581710|O2|Outcome|2 Weeks After Placebo Administration|Subjects will receive placebo. Each treatment period consists of 2 weeks
195748|NCT01581710|O1|Outcome|Baseline Lung Function|Before placebo or montelukast administration
195749|NCT01581710|O3|Outcome|2 Weeks After Montelukast Administration|Subjects will receive montelukast (4mg or 5mg) Each treatment period consists of 2 weeks
195750|NCT01581710|O2|Outcome|2 Weeks After Placebo Administration|Subjects will receive placebo. Each treatment period consists of 2 weeks
195751|NCT01581710|O1|Outcome|Baseline Lung Function|Before placebo or montelukast administration
195752|NCT01581710|O3|Outcome|2 Weeks After Montelukast Administration|Subjects will receive montelukast (4mg or 5mg) Each treatment period consists of 2 weeks
195753|NCT01581710|O2|Outcome|2 Weeks After Placebo Administration|Subjects will receive placebo. Each treatment period consists of 2 weeks
195754|NCT01581710|O1|Outcome|Baseline Lung Function|Before placebo or montelukast administration
195755|NCT01581710|E3|Reported Event|2 Weeks After Montelukast Administration|Subjects will receive montelukast (4mg or 5mg) Each treatment period consists of 2 weeks
195756|NCT01581710|E2|Reported Event|2 Weeks After Placebo Administration|Subjects will receive placebo. Each treatment period consists of 2 weeks
195757|NCT01581710|E1|Reported Event|Baseline Lung Function|Before placebo or montelukast administration
195758|NCT01581684|B11|Baseline|Total|Total of all reporting groups
195759|NCT01581684|B10|Baseline|20/60mg PM|Single oral dose of 20/60mg of BI 411034 for participants who are poor metabolisers
195760|NCT01581684|B9|Baseline|Placebo PM|A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)
195761|NCT01581684|B8|Baseline|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
195762|NCT01581684|B7|Baseline|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
195763|NCT01581684|B6|Baseline|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
195764|NCT01581684|B5|Baseline|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
195765|NCT01581684|B4|Baseline|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
195766|NCT01581684|B3|Baseline|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
195767|NCT01581684|B2|Baseline|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
195768|NCT01581684|B1|Baseline|Placebo EM|A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)
195769|NCT01581684|P10|Participant Flow|20/60mg PM|Single oral dose of 20/60mg of BI 411034 for participants who are poor metabolisers
195770|NCT01581684|P9|Participant Flow|Placebo PM|A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)
195771|NCT01581684|P8|Participant Flow|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
195772|NCT01581684|P7|Participant Flow|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
195773|NCT01581684|P6|Participant Flow|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
195774|NCT01581684|P5|Participant Flow|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
195775|NCT01581684|P4|Participant Flow|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
195776|NCT01581684|P3|Participant Flow|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
195777|NCT01581684|P2|Participant Flow|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
195778|NCT01581684|P1|Participant Flow|Placebo EM|A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)
195779|NCT01581684|O11|Outcome|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
195780|NCT01581684|O10|Outcome|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
195781|NCT01581684|O9|Outcome|Placebo PM|A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)
195782|NCT01581684|O8|Outcome|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
195783|NCT01581684|O7|Outcome|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
195784|NCT01581684|O6|Outcome|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
195785|NCT01581684|O5|Outcome|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
198192|NCT01572792|O4|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
195786|NCT01581684|O4|Outcome|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
195787|NCT01581684|O3|Outcome|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
195788|NCT01581684|O2|Outcome|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
195789|NCT01581684|O1|Outcome|Placebo EM|A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)
195790|NCT01581684|O11|Outcome|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
195791|NCT01581684|O10|Outcome|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
195792|NCT01581684|O9|Outcome|Placebo PM|A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)
195793|NCT01581684|O8|Outcome|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
195794|NCT01581684|O7|Outcome|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
195795|NCT01581684|O6|Outcome|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
195796|NCT01581684|O5|Outcome|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
195797|NCT01581684|O4|Outcome|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
195798|NCT01581684|O3|Outcome|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
195799|NCT01581684|O2|Outcome|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
195800|NCT01581684|O1|Outcome|Placebo EM|A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)
195801|NCT01581684|O9|Outcome|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
195802|NCT01581684|O8|Outcome|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
195803|NCT01581684|O7|Outcome|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
195804|NCT01581684|O6|Outcome|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
195805|NCT01581684|O5|Outcome|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
195806|NCT01581684|O4|Outcome|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
195807|NCT01581684|O3|Outcome|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
195808|NCT01581684|O2|Outcome|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
195809|NCT01581684|O1|Outcome|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
195810|NCT01581684|O9|Outcome|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
195811|NCT01581684|O8|Outcome|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
195812|NCT01581684|O7|Outcome|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
195813|NCT01581684|O6|Outcome|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
195814|NCT01581684|O5|Outcome|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
195815|NCT01581684|O4|Outcome|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
195816|NCT01581684|O3|Outcome|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
195817|NCT01581684|O2|Outcome|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
195818|NCT01581684|O1|Outcome|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
195819|NCT01581684|O9|Outcome|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
195820|NCT01581684|O8|Outcome|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
195821|NCT01581684|O7|Outcome|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
195822|NCT01581684|O6|Outcome|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
195823|NCT01581684|O5|Outcome|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
195824|NCT01581684|O4|Outcome|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
195825|NCT01581684|O3|Outcome|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
195826|NCT01581684|O2|Outcome|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
195827|NCT01581684|O1|Outcome|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
195828|NCT01581684|O9|Outcome|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
195829|NCT01581684|O8|Outcome|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
195830|NCT01581684|O7|Outcome|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
195831|NCT01581684|O6|Outcome|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
195832|NCT01581684|O5|Outcome|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
195833|NCT01581684|O4|Outcome|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
195834|NCT01581684|O3|Outcome|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
195835|NCT01581684|O2|Outcome|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
195836|NCT01581684|O1|Outcome|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
195837|NCT01581684|E11|Reported Event|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
195838|NCT01581684|E10|Reported Event|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
195839|NCT01581684|E9|Reported Event|Placebo PM|A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)
195840|NCT01581684|E8|Reported Event|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
195841|NCT01581684|E7|Reported Event|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
195842|NCT01581684|E6|Reported Event|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
195843|NCT01581684|E5|Reported Event|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
195844|NCT01581684|E4|Reported Event|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
195845|NCT01581684|E3|Reported Event|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
195846|NCT01581684|E2|Reported Event|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
195847|NCT01581684|E1|Reported Event|Placebo EM|A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)
195848|NCT01581658|B5|Baseline|Total|Total of all reporting groups
195849|NCT01581658|B4|Baseline|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
195850|NCT01581658|B3|Baseline|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
195851|NCT01581658|B2|Baseline|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
195852|NCT01581658|B1|Baseline|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
195853|NCT01581658|P4|Participant Flow|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
195854|NCT01581658|P3|Participant Flow|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
195855|NCT01581658|P2|Participant Flow|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
195856|NCT01581658|P1|Participant Flow|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
195857|NCT01581658|O4|Outcome|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
195858|NCT01581658|O3|Outcome|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
195859|NCT01581658|O2|Outcome|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
195860|NCT01581658|O1|Outcome|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
195861|NCT01581658|O4|Outcome|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
195862|NCT01581658|O3|Outcome|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
195863|NCT01581658|O2|Outcome|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
195864|NCT01581658|O1|Outcome|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
195865|NCT01581658|O4|Outcome|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
195866|NCT01581658|O3|Outcome|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
195867|NCT01581658|O2|Outcome|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
195868|NCT01581658|O1|Outcome|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
195869|NCT01581658|E4|Reported Event|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
195870|NCT01581658|E3|Reported Event|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
195871|NCT01581658|E2|Reported Event|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
195872|NCT01581658|E1|Reported Event|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
195873|NCT01581619|B1|Baseline|Partial Breast Irradiation|"Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks~External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks"
195874|NCT01581619|P1|Participant Flow|Partial Breast Irradiation|"Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks~External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks"
195875|NCT01581619|O1|Outcome|Partial Breast Irradiation|"Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks~External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks"
195876|NCT01581619|O1|Outcome|Partial Breast Irradiation|"Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks~External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks"
195877|NCT01581619|O2|Outcome|Partial Breast Irradiation - Invasive Cancer|"Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks~External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks~Participants with Invasive breast cancer"
195878|NCT01581619|O1|Outcome|Partial Breast Irradiation - DCIS Only|"Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks~External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks~Participants with DCIS only"
195879|NCT01581619|O1|Outcome|Partial Breast Irradiation|"Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks~External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks"
195880|NCT01581619|E1|Reported Event|Partial Breast Irradiation|"Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks~External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks"
195881|NCT01581541|B1|Baseline|PU-H71|PU-H71 will be administered intravenous (IV) over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195882|NCT01581541|P11|Participant Flow|PU-H71, 470 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195883|NCT01581541|P10|Participant Flow|PU-H71, 354 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195884|NCT01581541|P9|Participant Flow|PU-H71, 266 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195885|NCT01581541|P8|Participant Flow|PU-H71, 200 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195886|NCT01581541|P7|Participant Flow|PU-H71, 150 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195887|NCT01581541|P6|Participant Flow|PU-H71, 110 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195888|NCT01581541|P5|Participant Flow|PU-H71, 80 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195889|NCT01581541|P4|Participant Flow|PU-H71, 60 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195890|NCT01581541|P3|Participant Flow|PU-H71, 40 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195891|NCT01581541|P2|Participant Flow|PU-H71, 20 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195892|NCT01581541|P1|Participant Flow|PU-H71, 10 mg/m^2|PU-H71 will be administered intravenous (IV) over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195893|NCT01581541|O11|Outcome|PU-H71, 470 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195894|NCT01581541|O10|Outcome|PU-H71, 354 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195895|NCT01581541|O9|Outcome|PU-H71, 266 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195896|NCT01581541|O8|Outcome|PU-H71, 200 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195897|NCT01581541|O7|Outcome|PU-H71, 150 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195898|NCT01581541|O6|Outcome|PU-H71, 110 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195899|NCT01581541|O5|Outcome|PU-H71, 80 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195900|NCT01581541|O4|Outcome|PU-H71, 60 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195901|NCT01581541|O3|Outcome|PU-H71, 40 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195902|NCT01581541|O2|Outcome|PU-H71, 20 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195903|NCT01581541|O1|Outcome|PU-H71, 10 mg/m^2|PU-H71 will be administered intravenous (IV) over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195904|NCT01581541|O11|Outcome|PU-H71, 470 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195905|NCT01581541|O10|Outcome|PU-H71, 354 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195906|NCT01581541|O9|Outcome|PU-H71, 266 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195907|NCT01581541|O8|Outcome|PU-H71, 200 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195908|NCT01581541|O7|Outcome|PU-H71, 150 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195909|NCT01581541|O6|Outcome|PU-H71, 110 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195910|NCT01581541|O5|Outcome|PU-H71, 80 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195911|NCT01581541|O4|Outcome|PU-H71, 60 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195912|NCT01581541|O3|Outcome|PU-H71, 40 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195913|NCT01581541|O2|Outcome|PU-H71, 20 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195914|NCT01581541|O1|Outcome|PU-H71, 10 mg/m^2|PU-H71 will be administered intravenous (IV) over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195915|NCT01581541|O11|Outcome|PU-H71, 470 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195916|NCT01581541|O10|Outcome|PU-H71, 354 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195917|NCT01581541|O9|Outcome|PU-H71, 266 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195918|NCT01581541|O8|Outcome|PU-H71, 200 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195919|NCT01581541|O7|Outcome|PU-H71, 150 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195920|NCT01581541|O6|Outcome|PU-H71, 110 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195921|NCT01581541|O5|Outcome|PU-H71, 80 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195922|NCT01581541|O4|Outcome|PU-H71, 60 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195923|NCT01581541|O3|Outcome|PU-H71, 40 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195924|NCT01581541|O2|Outcome|PU-H71, 20 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195925|NCT01581541|O1|Outcome|PU-H71, 10 mg/m^2|PU-H71 will be administered intravenous (IV) over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195926|NCT01581541|O11|Outcome|PU-H71, 470 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195927|NCT01581541|O10|Outcome|PU-H71, 354 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195928|NCT01581541|O9|Outcome|PU-H71, 266 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195929|NCT01581541|O8|Outcome|PU-H71, 200 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195930|NCT01581541|O7|Outcome|PU-H71, 150 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195931|NCT01581541|O6|Outcome|PU-H71, 110 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195932|NCT01581541|O5|Outcome|PU-H71, 80 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195933|NCT01581541|O4|Outcome|PU-H71, 60 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195934|NCT01581541|O3|Outcome|PU-H71, 40 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195935|NCT01581541|O2|Outcome|PU-H71, 20 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195936|NCT01581541|O1|Outcome|PU-H71, 10 mg/m^2|PU-H71 will be administered intravenous (IV) over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195937|NCT01581541|O11|Outcome|PU-H71, 470 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195938|NCT01581541|O10|Outcome|PU-H71, 354 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195939|NCT01581541|O9|Outcome|PU-H71, 266 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195940|NCT01581541|O8|Outcome|PU-H71, 200 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195941|NCT01581541|O7|Outcome|PU-H71, 150 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195942|NCT01581541|O6|Outcome|PU-H71, 110 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195943|NCT01581541|O5|Outcome|PU-H71, 80 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195944|NCT01581541|O4|Outcome|PU-H71, 60 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195945|NCT01581541|O3|Outcome|PU-H71, 40 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195946|NCT01581541|O2|Outcome|PU-H71, 20 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195947|NCT01581541|O1|Outcome|PU-H71, 10 mg/m^2|PU-H71 will be administered intravenous (IV) over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195948|NCT01581541|O11|Outcome|PU-H71, 470 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195949|NCT01581541|O10|Outcome|PU-H71, 354 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195950|NCT01581541|O9|Outcome|PU-H71, 266 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195951|NCT01581541|O8|Outcome|PU-H71, 200 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195952|NCT01581541|O7|Outcome|PU-H71, 150 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195953|NCT01581541|O6|Outcome|PU-H71, 110 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195954|NCT01581541|O5|Outcome|PU-H71, 80 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195955|NCT01581541|O4|Outcome|PU-H71, 60 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195956|NCT01581541|O3|Outcome|PU-H71, 40 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195957|NCT01581541|O2|Outcome|PU-H71, 20 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195958|NCT01581541|O1|Outcome|PU-H71, 10 mg/m^2|PU-H71 will be administered intravenous (IV) over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195959|NCT01581541|O11|Outcome|PU-H71, 470 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195960|NCT01581541|O10|Outcome|PU-H71, 354 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195961|NCT01581541|O9|Outcome|PU-H71, 266 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195962|NCT01581541|O8|Outcome|PU-H71, 200 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195963|NCT01581541|O7|Outcome|PU-H71, 150 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
196121|NCT01580618|O1|Outcome|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
195964|NCT01581541|O6|Outcome|PU-H71, 110 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195965|NCT01581541|O5|Outcome|PU-H71, 80 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195966|NCT01581541|O4|Outcome|PU-H71, 60 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195967|NCT01581541|O3|Outcome|PU-H71, 40 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195968|NCT01581541|O2|Outcome|PU-H71, 20 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195969|NCT01581541|O1|Outcome|PU-H71, 10 mg/m^2|PU-H71 will be administered intravenous (IV) over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195970|NCT01581541|O11|Outcome|PU-H71, 470 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195971|NCT01581541|O10|Outcome|PU-H71, 354 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195972|NCT01581541|O9|Outcome|PU-H71, 266 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195973|NCT01581541|O8|Outcome|PU-H71, 200 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195974|NCT01581541|O7|Outcome|PU-H71, 150 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195975|NCT01581541|O6|Outcome|PU-H71, 110 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195976|NCT01581541|O5|Outcome|PU-H71, 80 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195977|NCT01581541|O4|Outcome|PU-H71, 60 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195978|NCT01581541|O3|Outcome|PU-H71, 40 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195979|NCT01581541|O2|Outcome|PU-H71, 20 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195980|NCT01581541|O1|Outcome|PU-H71, 10 mg/m^2|PU-H71 will be administered intravenous (IV) over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195981|NCT01581541|O1|Outcome|PU-H71|PU-H71 will be administered intravenous (IV) over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195982|NCT01581541|O11|Outcome|PU-H71, 470 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195983|NCT01581541|O10|Outcome|PU-H71, 354 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195984|NCT01581541|O9|Outcome|PU-H71, 266 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195985|NCT01581541|O8|Outcome|PU-H71, 200 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195986|NCT01581541|O7|Outcome|PU-H71, 150 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195987|NCT01581541|O6|Outcome|PU-H71, 110 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195988|NCT01581541|O5|Outcome|PU-H71, 80 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195989|NCT01581541|O4|Outcome|PU-H71, 60 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195990|NCT01581541|O3|Outcome|PU-H71, 40 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195991|NCT01581541|O2|Outcome|PU-H71, 20 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195992|NCT01581541|O1|Outcome|PU-H71, 10 mg/m^2|PU-H71 will be administered intravenous (IV) over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195993|NCT01581541|O11|Outcome|PU-H71, 470 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195994|NCT01581541|O10|Outcome|PU-H71, 354 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195995|NCT01581541|O9|Outcome|PU-H71, 266 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195996|NCT01581541|O8|Outcome|PU-H71, 200 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195997|NCT01581541|O7|Outcome|PU-H71, 150 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195998|NCT01581541|O6|Outcome|PU-H71, 110 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
195999|NCT01581541|O5|Outcome|PU-H71, 80 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
196000|NCT01581541|O4|Outcome|PU-H71, 60 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
196001|NCT01581541|O3|Outcome|PU-H71, 40 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
196002|NCT01581541|O2|Outcome|PU-H71, 20 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
196003|NCT01581541|O1|Outcome|PU-H71, 10 mg/m^2|PU-H71 will be administered intravenous (IV) over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
196004|NCT01581541|E11|Reported Event|PU-H71, 470 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
196122|NCT01580618|E2|Reported Event|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
196005|NCT01581541|E10|Reported Event|PU-H71, 354 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
196006|NCT01581541|E9|Reported Event|PU-H71, 266 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
196007|NCT01581541|E8|Reported Event|PU-H71, 200 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
196008|NCT01581541|E7|Reported Event|PU-H71, 150 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
196009|NCT01581541|E6|Reported Event|PU-H71, 110 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
196010|NCT01581541|E5|Reported Event|PU-H71, 80 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
196011|NCT01581541|E4|Reported Event|PU-H71, 60 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
196012|NCT01581541|E3|Reported Event|PU-H71, 40 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
196013|NCT01581541|E2|Reported Event|PU-H71, 20 mg/m^2|PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
196014|NCT01581541|E1|Reported Event|PU-H71, 10 mg/m^2|PU-H71 will be administered intravenous (IV) over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
196015|NCT01581437|B1|Baseline|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
196016|NCT01581437|P1|Participant Flow|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
196017|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter:"
196018|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter:"
196019|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: Outcome:78 patients enrolled multicenter"
196020|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
196021|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
196022|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.~Outcome:78 patients enrolled multicenter"
196023|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.~Outcome:78 patients enrolled multicenter."
196024|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
196025|NCT01581437|E1|Reported Event|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
196026|NCT01581307|B1|Baseline|2nd Line Chemotherapy With Radiotherapy|Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first‐line chemotherapy. Generally, second‐line chemotherapy was to be given every two weeks for 6‐10 cycles.
196027|NCT01581307|P1|Participant Flow|2nd Line Chemotherapy With Radiotherapy|"Administration of 2nd line chemotherapy will consist of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) will take place at least 2 weeks after the completion of first‐line chemotherapy. Generally, second‐line chemotherapy is given every two weeks for 6‐10 cycles.~The goal of treatment with TheraSpheres is to allow a large dose of radiation to be delivered directly to the tumor(s) with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue.~FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin): The usual treatment if gemcitabine chemotherapy has failed is chemotherapy with a drug combination called FOLFOX (folinic acid, 5-FU and oxaliplatin) given through a vein every 2 weeks for 6-10 cycles. Participants will receive this treatment.~TheraSpheres: TheraSpheres are a medical device containing yttrium-90 (Y-90), a radioactive material that has been used previously in the treatment of liver tumors."
196028|NCT01581307|O1|Outcome|2nd Line Chemotherapy With Radiotherapy|Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first‐line chemotherapy. Generally, second‐line chemotherapy was to be given every two weeks for 6‐10 cycles.
196029|NCT01581307|O1|Outcome|2nd Line Chemotherapy With Radiotherapy|Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first‐line chemotherapy. Generally, second‐line chemotherapy was to be given every two weeks for 6‐10 cycles.
196030|NCT01581307|O1|Outcome|2nd Line Chemotherapy With Radiotherapy|Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first‐line chemotherapy. Generally, second‐line chemotherapy was to be given every two weeks for 6‐10 cycles.
196031|NCT01581307|E1|Reported Event|2nd Line Chemotherapy With Radiotherapy|Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first‐line chemotherapy. Generally, second‐line chemotherapy was to be given every two weeks for 6‐10 cycles.
196032|NCT01581281|B4|Baseline|Total|Total of all reporting groups
196033|NCT01581281|B3|Baseline|Amitriptyline|Amitriptyline enclosed in capsules to maintain the blind was administered orally in dose of 1 capsule twice daily (AM capsule did not contain medication. A target dose was 1 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
196034|NCT01581281|B2|Baseline|Placebo|Placebo enclosed in capsules to maintain the blind was administered orally twice daily during an 8 week titration period followed by a 16 week maintenance phase (mirroring the other two treatment arms).
196035|NCT01581281|B1|Baseline|Topiramate|Topiramate enclosed in capsules to maintain the blind was administered orally in a divided dose of 1 capsule twice daily. A target dose was 2 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
196036|NCT01581281|P3|Participant Flow|Amitriptyline|Amitriptyline enclosed in capsules to maintain the blind was administered orally in dose of 1 capsule twice daily (AM capsule did not contain medication. A target dose was 1 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
196037|NCT01581281|P2|Participant Flow|Placebo|Placebo enclosed in capsules to maintain the blind was administered orally twice daily during an 8 week titration period followed by a 16 week maintenance phase (mirroring the other two treatment arms).
196038|NCT01581281|P1|Participant Flow|Topiramate|Topiramate enclosed in capsules to maintain the blind was administered orally in a divided dose of 1 capsule twice daily. A target dose was 2 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
196039|NCT01581281|O3|Outcome|Amitriptyline|Amitriptyline enclosed in capsules to maintain the blind was administered orally in dose of 1 capsule twice daily (AM capsule did not contain medication. A target dose was 1 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
196040|NCT01581281|O2|Outcome|Placebo|Placebo enclosed in capsules to maintain the blind was administered orally twice daily during an 8 week titration period followed by a 16 week maintenance phase (mirroring the other two treatment arms).
196041|NCT01581281|O1|Outcome|Topiramate|Topiramate enclosed in capsules to maintain the blind was administered orally in a divided dose of 1 capsule twice daily. A target dose was 2 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
196042|NCT01581281|O3|Outcome|Amitriptyline|Amitriptyline enclosed in capsules to maintain the blind was administered orally in dose of 1 capsule twice daily (AM capsule did not contain medication. A target dose was 1 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
196043|NCT01581281|O2|Outcome|Placebo|Placebo enclosed in capsules to maintain the blind was administered orally twice daily during an 8 week titration period followed by a 16 week maintenance phase (mirroring the other two treatment arms).
196044|NCT01581281|O1|Outcome|Topiramate|Topiramate enclosed in capsules to maintain the blind was administered orally in a divided dose of 1 capsule twice daily. A target dose was 2 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
196045|NCT01581281|O3|Outcome|Amitriptyline|Amitriptyline enclosed in capsules to maintain the blind was administered orally in dose of 1 capsule twice daily (AM capsule did not contain medication. A target dose was 1 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
196046|NCT01581281|O2|Outcome|Placebo|Placebo enclosed in capsules to maintain the blind was administered orally twice daily during an 8 week titration period followed by a 16 week maintenance phase (mirroring the other two treatment arms).
196047|NCT01581281|O1|Outcome|Topiramate|Topiramate enclosed in capsules to maintain the blind was administered orally in a divided dose of 1 capsule twice daily. A target dose was 2 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
196048|NCT01581281|O3|Outcome|Amitriptyline|Amitriptyline enclosed in capsules to maintain the blind was administered orally in dose of 1 capsule twice daily (AM capsule did not contain medication. A target dose was 1 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
196049|NCT01581281|O2|Outcome|Placebo|Placebo enclosed in capsules to maintain the blind was administered orally twice daily during an 8 week titration period followed by a 16 week maintenance phase (mirroring the other two treatment arms).
196050|NCT01581281|O1|Outcome|Topiramate|Topiramate enclosed in capsules to maintain the blind was administered orally in a divided dose of 1 capsule twice daily. A target dose was 2 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
203396|NCT01553318|O2|Outcome|Placebo|placebo group
196051|NCT01581281|O3|Outcome|Amitriptyline|Amitriptyline enclosed in capsules to maintain the blind was administered orally in dose of 1 capsule twice daily (AM capsule did not contain medication. A target dose was 1 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
196052|NCT01581281|O2|Outcome|Placebo|Placebo enclosed in capsules to maintain the blind was administered orally twice daily during an 8 week titration period followed by a 16 week maintenance phase (mirroring the other two treatment arms).
196053|NCT01581281|O1|Outcome|Topiramate|Topiramate enclosed in capsules to maintain the blind was administered orally in a divided dose of 1 capsule twice daily. A target dose was 2 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved
196054|NCT01581281|E3|Reported Event|Amitriptyline|Amitriptyline enclosed in capsules to maintain the blind was administered orally in dose of 1 capsule twice daily (AM capsule did not contain medication. A target dose was 1 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
196055|NCT01581281|E2|Reported Event|Placebo|Placebo enclosed in capsules to maintain the blind was administered orally twice daily during an 8 week titration period followed by a 16 week maintenance phase (mirroring the other two treatment arms).
196056|NCT01581281|E1|Reported Event|Topiramate|Topiramate enclosed in capsules to maintain the blind was administered orally in a divided dose of 1 capsule twice daily. A target dose was 2 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
196057|NCT01581021|B3|Baseline|Total|Total of all reporting groups
196058|NCT01581021|B2|Baseline|Laminar Hooks|Group treated with hooks in the thoracic spine
196059|NCT01581021|B1|Baseline|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
196060|NCT01581021|P2|Participant Flow|Laminar Hooks|Group treated with hooks in the thoracic spine
196061|NCT01581021|P1|Participant Flow|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
196062|NCT01581021|O2|Outcome|Laminar Hooks|Group treated with hooks in the thoracic spine
196063|NCT01581021|O1|Outcome|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
196064|NCT01581021|O2|Outcome|Laminar Hooks|Group treated with hooks in the thoracic spine
196065|NCT01581021|O1|Outcome|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
196066|NCT01581021|O2|Outcome|Laminar Hooks|Group treated with hooks in the thoracic spine
196067|NCT01581021|O1|Outcome|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
196068|NCT01581021|O2|Outcome|Laminar Hooks|Group treated with hooks in the thoracic spine
196069|NCT01581021|O1|Outcome|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
196070|NCT01581021|E2|Reported Event|Laminar Hooks|Group treated with hooks in the thoracic spine
196071|NCT01581021|E1|Reported Event|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
196072|NCT01581008|B3|Baseline|Total|Total of all reporting groups
196073|NCT01581008|B2|Baseline|Psychospiritual|A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
196074|NCT01581008|B1|Baseline|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
196075|NCT01581008|P2|Participant Flow|Psychospiritual|A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
196076|NCT01581008|P1|Participant Flow|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
196077|NCT01581008|O1|Outcome|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
196078|NCT01581008|O2|Outcome|Psychospiritual|A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
196079|NCT01581008|O1|Outcome|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
203397|NCT01553318|O1|Outcome|Ketotifen|active drug group
196080|NCT01581008|O2|Outcome|Psychospiritual|A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
196081|NCT01581008|O1|Outcome|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
196082|NCT01581008|E2|Reported Event|Psychospiritual|A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
196083|NCT01581008|E1|Reported Event|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
196084|NCT01580995|B3|Baseline|Total|Total of all reporting groups
196085|NCT01580995|B2|Baseline|Placebo|"Matching placebo twice daily~Placebo: Placebo tablet twice daily"
196086|NCT01580995|B1|Baseline|Valacyclovir|"Valacyclovir 500 mg po bid~Valacyclovir: Valacyclovir 500 mg po bid"
196087|NCT01580995|P2|Participant Flow|Placebo|"Matching placebo twice daily~Placebo: Placebo tablet twice daily"
196088|NCT01580995|P1|Participant Flow|Valacyclovir|"Valacyclovir 500 mg po bid~Valacyclovir: Valacyclovir 500 mg po bid"
196089|NCT01580995|O2|Outcome|Placebo|"Matching placebo twice daily~Placebo: Placebo tablet twice daily"
196090|NCT01580995|O1|Outcome|Valacyclovir|"Valacyclovir 500 mg po bid~Valacyclovir: Valacyclovir 500 mg po bid"
196091|NCT01580995|E2|Reported Event|Placebo|"Matching placebo twice daily~Placebo: Placebo tablet twice daily"
196092|NCT01580995|E1|Reported Event|Valacyclovir|"Valacyclovir 500 mg po bid~Valacyclovir: Valacyclovir 500 mg po bid"
196093|NCT01580904|B3|Baseline|Total|Total of all reporting groups
196094|NCT01580904|B2|Baseline|Control Group|Patients will not be followed by the pharmacist.
196095|NCT01580904|B1|Baseline|Intervention Group|"Patients will be followed by the pharmacist.~Intervention: Pharmaceutical Care : Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
196096|NCT01580904|P2|Participant Flow|Control Group|Patients will not be followed by the pharmacist.
196097|NCT01580904|P1|Participant Flow|Intervention Group|"Patients will be followed by the pharmacist.~Intervention: Pharmaceutical Care : Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
196098|NCT01580904|O2|Outcome|Intervention Group|"Patients will be followed by the pharmacist by Pharmacotherapeutic monitoring and dosing parameters such as glucose and glycated hemoglobin.~Intervention: Pharmaceutical Care~Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
196099|NCT01580904|O1|Outcome|Control Group|Patients will not be followed by the pharmacist.
196100|NCT01580904|O2|Outcome|Intervention Group|"Patients will be followed by the pharmacist by Pharmacotherapeutic monitoring and dosing parameters such as glucose and glycated hemoglobin.~Intervention: Pharmaceutical Care~Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
196101|NCT01580904|O1|Outcome|Control Group|Patients will not be followed by the pharmacist.
196102|NCT01580904|O2|Outcome|Intervention Group|"Patients will be followed by the pharmacist by Pharmacotherapeutic monitoring and dosing parameters such as glucose and glycated hemoglobin.~Intervention: Pharmaceutical Care~Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
196103|NCT01580904|O1|Outcome|Control Group|Patients will not be followed by the pharmacist.
196104|NCT01580904|O2|Outcome|Intervention Group|"Patients will be followed by the pharmacist.~Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
196105|NCT01580904|O1|Outcome|Control Group|Patients will not be followed by the pharmacist.
196106|NCT01580904|E2|Reported Event|Intervention Group|"Patients will be followed by the pharmacist.~Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
196107|NCT01580904|E1|Reported Event|Control Group|Patients will not be followed by the pharmacist.
196108|NCT01580618|B3|Baseline|Total|Total of all reporting groups
196109|NCT01580618|B2|Baseline|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
196110|NCT01580618|B1|Baseline|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
196111|NCT01580618|P2|Participant Flow|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
196112|NCT01580618|P1|Participant Flow|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
196113|NCT01580618|O2|Outcome|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
196114|NCT01580618|O1|Outcome|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
196115|NCT01580618|O2|Outcome|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
196116|NCT01580618|O1|Outcome|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
196117|NCT01580618|O1|Outcome|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
196118|NCT01580618|O2|Outcome|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
196119|NCT01580618|O1|Outcome|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
196120|NCT01580618|O2|Outcome|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
196123|NCT01580618|E1|Reported Event|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
196124|NCT01580592|B4|Baseline|Total|Total of all reporting groups
196125|NCT01580592|B3|Baseline|Placebo|Placebo: Placebo, s.c., every 4 weeks
196126|NCT01580592|B2|Baseline|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
196127|NCT01580592|B1|Baseline|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
196128|NCT01580592|P3|Participant Flow|Placebo|Placebo: Placebo, s.c., every 4 weeks
196129|NCT01580592|P2|Participant Flow|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
196130|NCT01580592|P1|Participant Flow|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
196131|NCT01580592|O3|Outcome|Placebo|Placebo: Placebo, s.c., every 4 weeks
196132|NCT01580592|O2|Outcome|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
196133|NCT01580592|O1|Outcome|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
196134|NCT01580592|O3|Outcome|Placebo|Placebo: Placebo, s.c., every 4 weeks
196135|NCT01580592|O2|Outcome|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
196136|NCT01580592|O1|Outcome|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
196137|NCT01580592|E3|Reported Event|Placebo|Placebo: Placebo, s.c., every 4 weeks
196138|NCT01580592|E2|Reported Event|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
196139|NCT01580592|E1|Reported Event|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
196140|NCT01580488|B1|Baseline|All Study Participants|
196141|NCT01580488|P1|Participant Flow|All Study Participants|"Each of the 24 subjects received all 6 investigational products on small dermal test sites: Topical cream formulation B containing 20 mg/g LEO 35299 Topical cream formulation C containing 20 mg/g LEO 35299 Topical solution formulation E containing 10 mg/g LEO 35299 Topical solution formulation F containing 10 mg/g LEO 35299 Topical ointment containing 50 mcg/g calcipotriol Topical ointment vehicle"
196142|NCT01580488|O6|Outcome|Daivonex® Ointment|Topical ointment vehicle
196143|NCT01580488|O5|Outcome|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
196144|NCT01580488|O4|Outcome|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
196145|NCT01580488|O3|Outcome|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
196146|NCT01580488|O2|Outcome|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
196147|NCT01580488|O1|Outcome|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
196148|NCT01580488|O6|Outcome|Daivonex® Ointment|Topical ointment vehicle
196149|NCT01580488|O5|Outcome|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
196150|NCT01580488|O4|Outcome|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
196151|NCT01580488|O3|Outcome|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
196152|NCT01580488|O2|Outcome|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
196153|NCT01580488|O1|Outcome|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
196154|NCT01580488|O6|Outcome|Daivonex® Ointment|Topical ointment vehicle
196155|NCT01580488|O5|Outcome|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
196156|NCT01580488|O4|Outcome|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
196157|NCT01580488|O3|Outcome|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
196158|NCT01580488|O2|Outcome|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
196159|NCT01580488|O1|Outcome|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
196160|NCT01580488|O6|Outcome|Daivonex® Ointment|Topical ointment vehicle
196161|NCT01580488|O5|Outcome|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
196162|NCT01580488|O4|Outcome|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
196163|NCT01580488|O3|Outcome|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
196164|NCT01580488|O2|Outcome|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
196165|NCT01580488|O1|Outcome|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
196166|NCT01580488|O6|Outcome|Daivonex® Ointment|Topical ointment vehicle
196167|NCT01580488|O5|Outcome|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
196168|NCT01580488|O4|Outcome|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
196169|NCT01580488|O3|Outcome|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
196170|NCT01580488|O2|Outcome|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
196171|NCT01580488|O1|Outcome|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
196172|NCT01580488|O6|Outcome|Daivonex® Ointment|Topical ointment vehicle
196173|NCT01580488|O5|Outcome|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
196174|NCT01580488|O4|Outcome|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
196175|NCT01580488|O3|Outcome|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
196176|NCT01580488|O2|Outcome|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
196177|NCT01580488|O1|Outcome|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
196178|NCT01580488|E6|Reported Event|Daivonex® Ointment|Topical ointment vehicle
196179|NCT01580488|E5|Reported Event|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
196180|NCT01580488|E4|Reported Event|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
196181|NCT01580488|E3|Reported Event|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
196182|NCT01580488|E2|Reported Event|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
196183|NCT01580488|E1|Reported Event|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
196184|NCT01580423|B1|Baseline|Entire Study Population|Includes groups randomized to receive aprepitant first and inert powder first.
196185|NCT01580423|P2|Participant Flow|First Inert Powder, Then Aprepitant|Capsule of inert powder in first intervention period and capsule of aprepitant 125 mg in second intervention period.
196186|NCT01580423|P1|Participant Flow|First Aprepitant, Then Inert Powder|Capsule of aprepitant 125 mg in first intervention period and capsule of inert powder in second intervention period.
196187|NCT01580423|O2|Outcome|Inert Powder|Capsule containing insert powder
196188|NCT01580423|O1|Outcome|Aprepitant|Capsule containing 125 mg of aprepitant
196189|NCT01580423|O2|Outcome|Inert Powder|Capsule containing inert powder
196190|NCT01580423|O1|Outcome|Aprepitant|Capsule containing 125 mg of aprepitant
196191|NCT01580423|O2|Outcome|Inert Powder|Capsule containing inert powder
196192|NCT01580423|O1|Outcome|Aprepitant|Capsule containing 125 mg of aprepitant
196193|NCT01580423|E2|Reported Event|Inert Powder|Capsule filled with inert powder
196194|NCT01580423|E1|Reported Event|Aprepitant|Capsule filled with 125 mg of aprepitant
196195|NCT01580410|B3|Baseline|Total|Total of all reporting groups
196196|NCT01580410|B2|Baseline|Arm II (Oxaliplatin)|"Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.~oxaliplatin: Given by HIPEC~therapeutic conventional surgery: Undergo surgery~quality-of-life assessment: Ancillary studies~hyperthermic intraperitoneal chemotherapy: Undergo HIPEC"
196197|NCT01580410|B1|Baseline|Arm I (Mitomycin C)|"Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.~mitomycin C: Given by HIPEC~therapeutic conventional surgery: Undergo surgery~quality-of-life assessment: Ancillary studies~hyperthermic intraperitoneal chemotherapy: Undergo HIPEC"
196198|NCT01580410|P2|Participant Flow|Arm II (Oxaliplatin)|"Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.~oxaliplatin: Given by HIPEC~therapeutic conventional surgery: Undergo surgery~quality-of-life assessment: Ancillary studies~hyperthermic intraperitoneal chemotherapy: Undergo HIPEC"
196199|NCT01580410|P1|Participant Flow|Arm I (Mitomycin C)|"Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.~mitomycin C: Given by HIPEC~therapeutic conventional surgery: Undergo surgery~quality-of-life assessment: Ancillary studies~hyperthermic intraperitoneal chemotherapy: Undergo HIPEC"
196200|NCT01580410|O2|Outcome|Arm II (Oxaliplatin)|"Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.~oxaliplatin: Given by HIPEC~therapeutic conventional surgery: Undergo surgery~quality-of-life assessment: Ancillary studies~hyperthermic intraperitoneal chemotherapy: Undergo HIPEC"
196201|NCT01580410|O1|Outcome|Arm I (Mitomycin C)|"Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.~mitomycin C: Given by HIPEC~therapeutic conventional surgery: Undergo surgery~quality-of-life assessment: Ancillary studies~hyperthermic intraperitoneal chemotherapy: Undergo HIPEC"
196202|NCT01580410|O2|Outcome|Arm II (Oxaliplatin)|"Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.~oxaliplatin: Given by HIPEC~therapeutic conventional surgery: Undergo surgery~quality-of-life assessment: Ancillary studies~hyperthermic intraperitoneal chemotherapy: Undergo HIPEC"
196203|NCT01580410|O1|Outcome|Arm I (Mitomycin C)|"Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.~mitomycin C: Given by HIPEC~therapeutic conventional surgery: Undergo surgery~quality-of-life assessment: Ancillary studies~hyperthermic intraperitoneal chemotherapy: Undergo HIPEC"
196204|NCT01580410|O2|Outcome|Arm II (Oxaliplatin)|"Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.~oxaliplatin: Given by HIPEC~therapeutic conventional surgery: Undergo surgery~quality-of-life assessment: Ancillary studies~hyperthermic intraperitoneal chemotherapy: Undergo HIPEC"
196205|NCT01580410|O1|Outcome|Arm I (Mitomycin C)|"Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.~mitomycin C: Given by HIPEC~therapeutic conventional surgery: Undergo surgery~quality-of-life assessment: Ancillary studies~hyperthermic intraperitoneal chemotherapy: Undergo HIPEC"
196206|NCT01580410|O2|Outcome|Arm II (Oxaliplatin)|"Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.~oxaliplatin: Given by HIPEC~therapeutic conventional surgery: Undergo surgery~quality-of-life assessment: Ancillary studies~hyperthermic intraperitoneal chemotherapy: Undergo HIPEC"
196207|NCT01580410|O1|Outcome|Arm I (Mitomycin C)|"Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.~mitomycin C: Given by HIPEC~therapeutic conventional surgery: Undergo surgery~quality-of-life assessment: Ancillary studies~hyperthermic intraperitoneal chemotherapy: Undergo HIPEC"
196208|NCT01580410|E2|Reported Event|Arm II (Oxaliplatin)|"Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.~oxaliplatin: Given by HIPEC~therapeutic conventional surgery: Undergo surgery~quality-of-life assessment: Ancillary studies~hyperthermic intraperitoneal chemotherapy: Undergo HIPEC"
196209|NCT01580410|E1|Reported Event|Arm I (Mitomycin C)|"Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.~mitomycin C: Given by HIPEC~therapeutic conventional surgery: Undergo surgery~quality-of-life assessment: Ancillary studies~hyperthermic intraperitoneal chemotherapy: Undergo HIPEC"
196210|NCT01580306|B5|Baseline|Total|Total of all reporting groups
196211|NCT01580306|B4|Baseline|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
196212|NCT01580306|B3|Baseline|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
196213|NCT01580306|B2|Baseline|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
196214|NCT01580306|B1|Baseline|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
196215|NCT01580306|P4|Participant Flow|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
196216|NCT01580306|P3|Participant Flow|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
196382|NCT01579747|P1|Participant Flow|Nerve Stimulation Sciatic Nerve Block|Sciatic nerve block performed with nerve stimulation
196217|NCT01580306|P2|Participant Flow|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
196218|NCT01580306|P1|Participant Flow|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
196219|NCT01580306|O4|Outcome|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
196220|NCT01580306|O3|Outcome|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
196221|NCT01580306|O2|Outcome|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
196222|NCT01580306|O1|Outcome|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
196223|NCT01580306|O4|Outcome|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
196224|NCT01580306|O3|Outcome|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
196225|NCT01580306|O2|Outcome|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
196226|NCT01580306|O1|Outcome|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
196227|NCT01580306|O4|Outcome|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
196228|NCT01580306|O3|Outcome|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
196229|NCT01580306|O2|Outcome|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
196230|NCT01580306|O1|Outcome|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
196231|NCT01580306|O4|Outcome|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
196232|NCT01580306|O3|Outcome|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
196233|NCT01580306|O2|Outcome|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
196234|NCT01580306|O1|Outcome|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
196235|NCT01580306|E4|Reported Event|BI 201335 Relevant Treatment Dose (Severe Renal Impairment)|"Capsule for oral administration~estimated glomerular filtration rate 15-29 mL/min/1.73m2"
196236|NCT01580306|E3|Reported Event|BI 201335 Relevant Treatment Dose (Moderate Renal Impairment)|"Capsule for oral administration~estimated glomerular filtration rate 30-59 mL/min/1.73m2"
196237|NCT01580306|E2|Reported Event|BI 201335 Relevant Treatment Dose (Mild Renal Impairment)|"Capsule for oral administration~estimated glomerular filtration rate 60-89 mL/min/1.73m2"
196238|NCT01580306|E1|Reported Event|BI 201335 Relevant Treatment Dose (Normal Renal Function)|"Capsule for oral administration~estimated glomerular filtration rate >= 90 mL/min/1.73m2"
196239|NCT01580098|B3|Baseline|Total|Total of all reporting groups
196240|NCT01580098|B2|Baseline|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
196241|NCT01580098|B1|Baseline|Control Group|treatment as usual
196242|NCT01580098|P3|Participant Flow|Nurse-monitoring for Patients With Diabetes Mellitus Type 2|"nurse-monitoring for patients with Diabetes Mellitus~Nurses are entering vital parameters of the patient with mobile devices"
196243|NCT01580098|P2|Participant Flow|Self-monitoring for Patients With Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital."
196244|NCT01580098|P1|Participant Flow|Control Group|treatment as usual
196245|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
196246|NCT01580098|O1|Outcome|Control Group|treatment as usual
196247|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
196248|NCT01580098|O1|Outcome|Control Group|treatment as usual
196383|NCT01579747|O2|Outcome|Ultrasound Guided Sciatic Nerve Block|Sciatic nerve block performed with ultrasound guidance
196249|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
196250|NCT01580098|O1|Outcome|Control Group|treatment as usual
196251|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
196252|NCT01580098|O1|Outcome|Control Group|treatment as usual
196253|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
196254|NCT01580098|O1|Outcome|Control Group|treatment as usual
196255|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
196256|NCT01580098|O1|Outcome|Control Group|treatment as usual
196257|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
196258|NCT01580098|O1|Outcome|Control Group|treatment as usual
196259|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters. Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
196260|NCT01580098|O1|Outcome|Control Group|treatment as usual
196261|NCT01580098|E2|Reported Event|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Home nursing is also included. Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
196262|NCT01580098|E1|Reported Event|Control Group|treatment as usual
196263|NCT01580072|B4|Baseline|Total|Total of all reporting groups
196264|NCT01580072|B3|Baseline|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
196265|NCT01580072|B2|Baseline|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
196266|NCT01580072|B1|Baseline|Control Group|Participants in the control group receive usual care.
196267|NCT01580072|P3|Participant Flow|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
196268|NCT01580072|P2|Participant Flow|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
196269|NCT01580072|P1|Participant Flow|Control Group|Participants in the control group receive usual care.
196270|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
196271|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
196272|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
198408|NCT01571453|B2|Baseline|Venlafaxine|Venlafaxine extended release: 150 mg/day
196273|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
196274|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
196275|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
196276|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
196277|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
196278|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
196279|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
196280|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
196281|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
196282|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
196283|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
196284|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
196285|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
196286|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
196287|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
196288|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
196289|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
196290|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
196291|NCT01580072|E3|Reported Event|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
196292|NCT01580072|E2|Reported Event|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
196293|NCT01580072|E1|Reported Event|Control Group|Participants in the control group receive usual care.
196294|NCT01580020|B3|Baseline|Total|Total of all reporting groups
196295|NCT01580020|B2|Baseline|Dexamethasone|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
196296|NCT01580020|B1|Baseline|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
196297|NCT01580020|P4|Participant Flow|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
196298|NCT01580020|P3|Participant Flow|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitrally
196299|NCT01580020|P2|Participant Flow|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
196300|NCT01580020|P1|Participant Flow|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
196301|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
196302|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
196303|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
196304|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
196305|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
196306|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
196307|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
196308|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
196309|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
196310|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
196311|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
196312|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
196313|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
196314|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
196315|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
196316|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
196317|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
196318|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
196319|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
196320|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
196321|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
196322|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
196323|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
196324|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
196325|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
196326|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
196327|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
196328|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
196329|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
196330|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
196331|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
196332|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
196333|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
196334|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
196335|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
196336|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
196360|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
203398|NCT01553318|O2|Outcome|Placebo|received placebo
196337|NCT01580020|E4|Reported Event|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
196338|NCT01580020|E3|Reported Event|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
196339|NCT01580020|E2|Reported Event|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
196340|NCT01580020|E1|Reported Event|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
196341|NCT01579916|B3|Baseline|TOTAL|Total of all reporting groups
196342|NCT01579916|B2|Baseline|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
196343|NCT01579916|B1|Baseline|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
196344|NCT01579916|P2|Participant Flow|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
196345|NCT01579916|P1|Participant Flow|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
196346|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
196347|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
196348|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
196349|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
196350|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
196351|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
196352|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
196353|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
196354|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
196355|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
196356|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
196357|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
196358|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
196359|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
196381|NCT01579747|P2|Participant Flow|Ultrasound Guided Sciatic Nerve Block|Sciatic nerve block performed with ultrasound guidance
196361|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
196362|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
196363|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
196364|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
196365|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
196366|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
196367|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
196368|NCT01579916|E2|Reported Event|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
196369|NCT01579916|E1|Reported Event|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
196370|NCT01579812|B1|Baseline|Metformin|"Metformin: Patients receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.~Patients treated with neoadjuvant chemotherapy will be initiated on metformin prior to the initiation of chemotherapy. Following surgery patients will be initiated on metformin prior to the re-initiation of chemotherapy."
196371|NCT01579812|P1|Participant Flow|Metformin|"Metformin: Patients receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.~Patients treated with neoadjuvant chemotherapy will be initiated on metformin prior to the initiation of chemotherapy. Following surgery patients will be initiated on metformin prior to the re-initiation of chemotherapy."
196372|NCT01579812|O3|Outcome|Metformin - Patients With Stage IV Ovarian Cancer|Patients with stage IV ovarian cancer receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.
196373|NCT01579812|O2|Outcome|Metformin - Patients Stage IIc/ III Ovarian Cancer|Patients with stage IIc/ III ovarian cancer receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.
196374|NCT01579812|O1|Outcome|Metformin - All Patients Analyzed|"Metformin: Patients receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.~Patients treated with neoadjuvant chemotherapy will be initiated on metformin prior to the initiation of chemotherapy. Following surgery patients will be initiated on metformin prior to the re-initiation of chemotherapy."
196375|NCT01579812|O2|Outcome|Metformin - Patients With Persistent Disease Excluded|"Metformin: Patients receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.~Patients treated with neoadjuvant chemotherapy will be initiated on metformin prior to the initiation of chemotherapy. Following surgery patients will be initiated on metformin prior to the re-initiation of chemotherapy.~Patients with persistent disease were excluded in this analysis."
196376|NCT01579812|O1|Outcome|Metformin - All Patients Analyzed|"Metformin: Patients receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.~Patients treated with neoadjuvant chemotherapy will be initiated on metformin prior to the initiation of chemotherapy. Following surgery patients will be initiated on metformin prior to the re-initiation of chemotherapy."
196377|NCT01579812|E1|Reported Event|Metformin|"Metformin: Patients receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.~Patients treated with neoadjuvant chemotherapy will be initiated on metformin prior to the initiation of chemotherapy. Following surgery patients will be initiated on metformin prior to the re-initiation of chemotherapy."
196378|NCT01579747|B3|Baseline|Total|Total of all reporting groups
196379|NCT01579747|B2|Baseline|Ultrasound Guided Sciatic Nerve Block|Sciatic nerve block performed with ultrasound guidance
196380|NCT01579747|B1|Baseline|Nerve Stimulation Sciatic Nerve Block|Sciatic nerve block performed with nerve stimulation
198409|NCT01571453|B1|Baseline|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
196384|NCT01579747|O1|Outcome|Nerve Stimulation Sciatic Nerve Block|Sciatic nerve block performed with nerve stimulation
196385|NCT01579747|O2|Outcome|Ultrasound Guided Sciatic Nerve Block|Sciatic nerve block performed with ultrasound guidance
196386|NCT01579747|O1|Outcome|Nerve Stimulation Sciatic Nerve Block|Sciatic nerve block performed with nerve stimulation
196387|NCT01579747|E2|Reported Event|Ultrasound Guided Sciatic Nerve Block|Time taken to complete a sciatic nerve block via the lateral popliteal approach when using an ultrasound
196388|NCT01579747|E1|Reported Event|Nerve Stimulation Sciatic Nerve Block|Time taken to complete a sciatic nerve block via the lateral popliteal approach using nerve stimulation
196389|NCT01579669|B3|Baseline|Total|Total of all reporting groups
196390|NCT01579669|B2|Baseline|Primary Care Providers|Primary care providers taking care of autistic adults participating in this study
196391|NCT01579669|B1|Baseline|Autistic Adults|Adults on the autism spectrum
196392|NCT01579669|P2|Participant Flow|Primary Care Providers|Participants' primary care providers
196393|NCT01579669|P1|Participant Flow|Autistic Adults|Adults on the autism spectrum
196394|NCT01579669|O1|Outcome|Autistic Adults|Adults on the autism spectrum
196395|NCT01579669|O1|Outcome|Autistic Adults|Adults on the autism spectrum
196396|NCT01579669|O1|Outcome|Autistic Adults|Adults on the autism spectrum
196397|NCT01579669|O1|Outcome|Autistic Adults|Adults on the autism spectrum
196398|NCT01579669|O1|Outcome|Primary Care Providers|Participants' primary care providers
196399|NCT01579669|O1|Outcome|Autistic Adults|Adults on the autism spectrum
196400|NCT01579669|E2|Reported Event|Primary Care Providers|Primary care providers of autistic adults participating in the study.
196401|NCT01579669|E1|Reported Event|Autistic Adults|Adults on the autism spectrum
196402|NCT01579578|B3|Baseline|Total|Total of all reporting groups
196403|NCT01579578|B2|Baseline|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
196404|NCT01579578|B1|Baseline|AZD8931 40mg + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
196405|NCT01579578|P2|Participant Flow|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
196406|NCT01579578|P1|Participant Flow|AZD8931 40mg + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
196407|NCT01579578|O2|Outcome|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
196408|NCT01579578|O1|Outcome|AZD8931 + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
196409|NCT01579578|O2|Outcome|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
196410|NCT01579578|O1|Outcome|AZD8931 + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
196411|NCT01579578|O2|Outcome|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
196412|NCT01579578|O1|Outcome|AZD8931 + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
196413|NCT01579578|E2|Reported Event|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
196414|NCT01579578|E1|Reported Event|AZD8931 40mg + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
196415|NCT01579565|B3|Baseline|Total|Total of all reporting groups
196416|NCT01579565|B2|Baseline|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196417|NCT01579565|B1|Baseline|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196418|NCT01579565|P2|Participant Flow|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196713|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
196419|NCT01579565|P1|Participant Flow|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 millimolar (mM) phenylephrine hydrochloride (HCl) and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available balanced saline solution (BSS) through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196420|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196421|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196422|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196423|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196424|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196425|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196426|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196427|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196428|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196429|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196466|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
196467|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
196430|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196431|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196432|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196433|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196434|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196435|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196436|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196437|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196438|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196439|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196440|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196441|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196442|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196443|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196444|NCT01579565|E2|Reported Event|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196445|NCT01579565|E1|Reported Event|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
196446|NCT01579474|B7|Baseline|Total|Total of all reporting groups
196447|NCT01579474|B6|Baseline|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
196448|NCT01579474|B5|Baseline|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
196449|NCT01579474|B4|Baseline|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
196450|NCT01579474|B3|Baseline|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
196451|NCT01579474|B2|Baseline|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196452|NCT01579474|B1|Baseline|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196453|NCT01579474|P6|Participant Flow|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
196454|NCT01579474|P5|Participant Flow|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
196455|NCT01579474|P4|Participant Flow|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
196456|NCT01579474|P3|Participant Flow|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
196457|NCT01579474|P2|Participant Flow|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196458|NCT01579474|P1|Participant Flow|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily (q.d.) for 12 or 24 weeks combined with pegylated interferon alfa-2b and ribavirin (PegIFNα-2b/RBV) for 24 weeks in treatment-naive patients.
196459|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
196460|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
196461|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
196462|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
196463|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196464|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196465|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
196468|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
196469|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196470|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196471|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
196472|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
196473|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
196474|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
196475|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196476|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196477|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
196478|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
196479|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
196480|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
196481|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196482|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196483|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
196484|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
196485|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
196486|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
196487|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196488|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196489|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
196490|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
196491|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
196492|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
196493|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196494|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196495|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
196496|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
196565|NCT01579084|B8|Baseline|AGN-199201 Formulation B|AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days.
196497|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
196498|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
196499|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196500|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196501|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
196502|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
196503|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
196504|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
196505|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196506|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196507|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
196508|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
196509|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
196510|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
196511|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196512|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196513|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
196514|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
196515|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
196516|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
196517|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196518|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196519|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
196520|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
196521|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
196522|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined withPegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
196523|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196524|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196525|NCT01579474|O3|Outcome|Faldaprevir 240 mg q.d - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients.
203399|NCT01553318|O1|Outcome|Ketotifen|Ketotifen active drug
196526|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196527|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
196528|NCT01579474|E3|Reported Event|Faldaprevir 240 mg q.d - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients.
196529|NCT01579474|E2|Reported Event|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFN/RBV for 24 weeks in treatment-naive patients.
196530|NCT01579474|E1|Reported Event|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFN/RBV for 24 weeks in treatment-naive patients.
196531|NCT01579318|B1|Baseline|Treatment|Participants received up to 4 cycles of treatment (3 daily treatments on Days 1, 5 and 8, in a 12-week cycle) of intratumoral injection(s) of tavo at a concentration of 1.0 mg/mL (maximum volume of 1 mL/day distributed over 2-4 lesions), followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid deoxyribonucleic acid (DNA) into tumor cells.
196532|NCT01579318|P1|Participant Flow|Treatment|Participants received up to 4 cycles of treatment (3 daily treatments on Days 1, 5 and 8, in a 12-week cycle) of intratumoral injection(s) of tavo at a concentration of 1.0 mg/mL (maximum volume of 1 mL/day distributed over 2-4 lesions), followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid deoxyribonucleic acid (DNA) into tumor cells.
196533|NCT01579318|O1|Outcome|Treatment|Participants received up to 4 cycles of treatment (3 daily treatments on Days 1, 5 and 8, in a 12-week cycle) of intratumoral injection(s) of tavo at a concentration of 1.0 mg/mL (maximum volume of 1 mL/day distributed over 2-4 lesions), followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid deoxyribonucleic acid (DNA) into tumor cells.
196534|NCT01579318|O1|Outcome|Treatment|Participants received up to 4 cycles of treatment (3 daily treatments on Days 1, 5 and 8, in a 12-week cycle) of intratumoral injection(s) of tavo at a concentration of 1.0 mg/mL (maximum volume of 1 mL/day distributed over 2-4 lesions), followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid deoxyribonucleic acid (DNA) into tumor cells.
196535|NCT01579318|O1|Outcome|Treatment|Participants received up to 4 cycles of treatment (3 daily treatments on Days 1, 5 and 8, in a 12-week cycle) of intratumoral injection(s) of tavo at a concentration of 1.0 mg/mL (maximum volume of 1 mL/day distributed over 2-4 lesions), followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid deoxyribonucleic acid (DNA) into tumor cells.
196536|NCT01579318|O1|Outcome|Treatment|Participants received up to 4 cycles of treatment (3 daily treatments on Days 1, 5 and 8, in a 12-week cycle) of intratumoral injection(s) of tavo at a concentration of 1.0 mg/mL (maximum volume of 1 mL/day distributed over 2-4 lesions), followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid deoxyribonucleic acid (DNA) into tumor cells.
196537|NCT01579318|O1|Outcome|Treatment|Participants received up to 4 cycles of treatment (3 daily treatments on Days 1, 5 and 8, in a 12-week cycle) of intratumoral injection(s) of tavo at a concentration of 1.0 mg/mL (maximum volume of 1 mL/day distributed over 2-4 lesions), followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid deoxyribonucleic acid (DNA) into tumor cells.
196538|NCT01579318|O1|Outcome|Treatment|Participants received up to 4 cycles of treatment (3 daily treatments on Days 1, 5 and 8, in a 12-week cycle) of intratumoral injection(s) of tavo at a concentration of 1.0 mg/mL (maximum volume of 1 mL/day distributed over 2-4 lesions), followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid deoxyribonucleic acid (DNA) into tumor cells.
196539|NCT01579318|O1|Outcome|Treatment|Participants received up to 4 cycles of treatment (3 daily treatments on Days 1, 5 and 8, in a 12-week cycle) of intratumoral injection(s) of tavo at a concentration of 1.0 mg/mL (maximum volume of 1 mL/day distributed over 2-4 lesions), followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid deoxyribonucleic acid (DNA) into tumor cells.
196540|NCT01579318|O1|Outcome|Treatment|Participants received up to 4 cycles of treatment (3 daily treatments on Days 1, 5 and 8, in a 12-week cycle) of intratumoral injection(s) of tavo at a concentration of 1.0 mg/mL (maximum volume of 1 mL/day distributed over 2-4 lesions), followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid deoxyribonucleic acid (DNA) into tumor cells.
196541|NCT01579318|E1|Reported Event|Treatment|Participants received up to 4 cycles of treatment (3 daily treatments on Days 1, 5 and 8, in a 12-week cycle) of intratumoral injection(s) of tavo at a concentration of 1.0 mg/mL (maximum volume of 1 mL/day distributed over 2-4 lesions), followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid deoxyribonucleic acid (DNA) into tumor cells.
196542|NCT01579305|B3|Baseline|Total|Total of all reporting groups
196543|NCT01579305|B2|Baseline|Subjects Randomized to Receive Restylane-L®|
196544|NCT01579305|B1|Baseline|Subjects Randomized to Receive VOLBELLA®|
196545|NCT01579305|P2|Participant Flow|Subjects Randomized to Receive Restylane-L®|
196546|NCT01579305|P1|Participant Flow|Subject Randomized to Receive VOLBELLA®|
196547|NCT01579305|O2|Outcome|Subjects Randomized to Receive Restylane-L® and Treated|
196548|NCT01579305|O1|Outcome|Subjects Randomized to Receive VOLBELLA® and Treated|
196549|NCT01579305|E2|Reported Event|Subjects Treated With Restylane-L®|
196550|NCT01579305|E1|Reported Event|Subjects Treated With VOLBELLA®|
196551|NCT01579214|B3|Baseline|Total|Total of all reporting groups
196566|NCT01579084|B7|Baseline|AGN-199201 Formulation A|AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days.
196567|NCT01579084|B6|Baseline|AGN-199201 Formulation C and Vehicle|AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
198410|NCT01571453|P2|Participant Flow|Venlafaxine|Venlafaxine extended release 150 mg/day
196552|NCT01579214|B2|Baseline|Intervention Period|"Participants in the intervention period (September 2012 – November 2013) were receive daily short message service (SMS) messages for up to seven days in one of three formats: 1) messages reporting an abnormal result directly, 2) personal identification number-protected messages reporting an abnormal result, or 3) messages reading “ABCDEFG” to confidentially convey an abnormal result.~For our a priori hypothesis, we aimed to test whether clinical outcomes, i.e. time to clinic return and time to ART initiation, were different in the pre-intervention and intervention period. This was a non-randomized allocation.~During the intervention period, clinicians used eligibility criteria identical to those used during the pre-intervention period, including selection of an abnormal cluster of differentiation 4 (CD4) count threshold to trigger the SMS and transportation reimbursement intervention."
196553|NCT01579214|B1|Baseline|Pre-Intervention Control Group|Eligible participants from a pre-intervention period (January-August 2012) prior to their receiving SMS messages about their laboratory test results. During the pre-intervention stage, clinicians completed eligibility forms for each participant, including confirmation of access to a cellular phone, district of residence, and selection of the abnormal result threshold for the cluster of differentiation 4 (CD4) test, which would prompt a request for an early return to clinic. Standard clinical forms were completed to collect data on sociodemographic and clinical characteristics. We also collected data on the laboratory result and result date, time from laboratory result to clinic return, and for antiretroviral therapy (ART) naive participants, time to ART initiation.
196554|NCT01579214|P2|Participant Flow|Intervention Group|Received a text message stating laboratory results were abnormal and requesting return to clinic.
196555|NCT01579214|P1|Participant Flow|Pre-Intervention Control Group|Participants followed prior to SMS intervention as a negative control group.
196556|NCT01579214|O2|Outcome|Intervention Period|"Participants in the intervention period (September 2012 – November 2013) were receive daily short message service (SMS) messages for up to seven days in one of three formats: 1) messages reporting an abnormal result directly, 2) personal identification number-protected messages reporting an abnormal result, or 3) messages reading “ABCDEFG” to confidentially convey an abnormal result.~For our a priori hypothesis, we aimed to test whether clinical outcomes, i.e. time to clinic return and time to ART initiation, were different in the pre-intervention and intervention period. This was a non-randomized allocation.~During the intervention period, clinicians used eligibility criteria identical to those used during the pre-intervention period, including selection of an abnormal cluster of differentiation 4 (CD4) count threshold to trigger the SMS and transportation reimbursement intervention."
196557|NCT01579214|O1|Outcome|Pre-Intervention Control Group|Eligible participants from a pre-intervention period (January-August 2012) prior to their receiving SMS messages about their laboratory test results. During the pre-intervention stage, clinicians completed eligibility forms for each participant, including confirmation of access to a cellular phone, district of residence, and selection of the abnormal result threshold for the cluster of differentiation 4 (CD4) test, which would prompt a request for an early return to clinic. Standard clinical forms were completed to collect data on sociodemographic and clinical characteristics. We also collected data on the laboratory result and result date, time from laboratory result to clinic return, and for antiretroviral therapy (ART) naive participants, time to ART initiation.
196558|NCT01579214|O2|Outcome|Intervention Period|"Participants in the intervention period (September 2012 – November 2013) were receive daily short message service (SMS) messages for up to seven days in one of three formats: 1) messages reporting an abnormal result directly, 2) personal identification number-protected messages reporting an abnormal result, or 3) messages reading “ABCDEFG” to confidentially convey an abnormal result.~For our a priori hypothesis, we aimed to test whether clinical outcomes, i.e. time to clinic return and time to ART initiation, were different in the pre-intervention and intervention period. This was a non-randomized allocation.~During the intervention period, clinicians used eligibility criteria identical to those used during the pre-intervention period, including selection of an abnormal cluster of differentiation 4 (CD4) count threshold to trigger the SMS and transportation reimbursement intervention."
196559|NCT01579214|O1|Outcome|Pre-Intervention Control Group|Eligible participants from a pre-intervention period (January-August 2012) prior to their receiving SMS messages about their laboratory test results. During the pre-intervention stage, clinicians completed eligibility forms for each participant, including confirmation of access to a cellular phone, district of residence, and selection of the abnormal result threshold for the cluster of differentiation 4 (CD4) test, which would prompt a request for an early return to clinic. Standard clinical forms were completed to collect data on sociodemographic and clinical characteristics. We also collected data on the laboratory result and result date, time from laboratory result to clinic return, and for antiretroviral therapy (ART) naive participants, time to ART initiation.
196560|NCT01579214|E2|Reported Event|Intervention Period|"Participants in the intervention period (September 2012 – November 2013) were randomized to receive daily short message service (SMS) messages for up to seven days in one of three formats: 1) messages reporting an abnormal result directly, 2) personal identification number-protected messages reporting an abnormal result, or 3) messages reading “ABCDEFG” to confidentially convey an abnormal result.~During the intervention period, clinicians used eligibility criteria identical to those used during the pre-intervention period, including selection of an abnormal cluster of differentiation 4 (CD4) count threshold to trigger the SMS and transportation reimbursement intervention."
196561|NCT01579214|E1|Reported Event|Pre-Intervention Control Group|Eligible participants from a pre-intervention period (January-August 2012) prior to their receiving SMS messages about their laboratory test results. During the pre-intervention stage, clinicians completed eligibility forms for each participant, including confirmation of access to a cellular phone, district of residence, and selection of the abnormal result threshold for the cluster of differentiation 4 (CD4) test, which would prompt a request for an early return to clinic. Standard clinical forms were completed to collect data on sociodemographic and clinical characteristics. We also collected data on the laboratory result and result date, time from laboratory result to clinic return, and for antiretroviral therapy (ART) naive participants, time to ART initiation.
196562|NCT01579084|B11|Baseline|Total|Total of all reporting groups
196563|NCT01579084|B10|Baseline|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days.
196564|NCT01579084|B9|Baseline|AGN-199201 Formulation C|AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days.
198411|NCT01571453|P1|Participant Flow|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
196568|NCT01579084|B5|Baseline|AGN-199201 Formulation B and Vehicle|AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
196569|NCT01579084|B4|Baseline|AGN-199201 Formulation A and Vehicle|AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
196570|NCT01579084|B3|Baseline|AGN-199201 Formulation C and A|AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily for 5 days.
196571|NCT01579084|B2|Baseline|AGN-199201 Formulation B and C|AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily for 5 days.
196572|NCT01579084|B1|Baseline|AGN-199201 Formulation A and B|AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily for 5 days.
196573|NCT01579084|P10|Participant Flow|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days.
196574|NCT01579084|P9|Participant Flow|AGN-199201 Formulation C|AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days.
196575|NCT01579084|P8|Participant Flow|AGN-199201 Formulation B|AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days.
196576|NCT01579084|P7|Participant Flow|AGN-199201 Formulation A|AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days.
196577|NCT01579084|P6|Participant Flow|AGN-199201 Formulation C and Vehicle|AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
196578|NCT01579084|P5|Participant Flow|AGN-199201 Formulation B and Vehicle|AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
196579|NCT01579084|P4|Participant Flow|AGN-199201 Formulation A and Vehicle|AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
196580|NCT01579084|P3|Participant Flow|AGN-199201 Formulation C and A|AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily for 5 days.
196581|NCT01579084|P2|Participant Flow|AGN-199201 Formulation B and C|AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily for 5 days.
196582|NCT01579084|P1|Participant Flow|AGN-199201 Formulation A and B|AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily for 5 days.
196583|NCT01579084|O4|Outcome|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to the face twice daily for 5 days. Includes participants treated with Vehicle in any of the randomized treatment groups.
196584|NCT01579084|O3|Outcome|AGN-199201 Formulation C|AGN-199201 Formulation C applied to the face twice daily for 5 days. Includes participants treated with Formulation C in any of the randomized treatment groups.
196585|NCT01579084|O2|Outcome|AGN-199201 Formulation B|AGN-199201 Formulation B applied to the face twice daily for 5 days. Includes participants treated with Formulation B in any of the randomized treatment groups.
196586|NCT01579084|O1|Outcome|AGN-199201 Formulation A|AGN-199201 Formulation A applied to the face twice daily for 5 days. Includes participants treated with Formulation A in any of the randomized treatment groups.
196587|NCT01579084|O4|Outcome|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to the face twice daily for 5 days. Includes participants treated with Vehicle in any of the randomized treatment groups.
196588|NCT01579084|O3|Outcome|AGN-199201 Formulation C|AGN-199201 Formulation C applied to the face twice daily for 5 days. Includes participants treated with Formulation C in any of the randomized treatment groups.
196589|NCT01579084|O2|Outcome|AGN-199201 Formulation B|AGN-199201 Formulation B applied to the face twice daily for 5 days. Includes participants treated with Formulation B in any of the randomized treatment groups.
196590|NCT01579084|O1|Outcome|AGN-199201 Formulation A|AGN-199201 Formulation A applied to the face twice daily for 5 days. Includes participants treated with Formulation A in any of the randomized treatment groups.
196591|NCT01579084|O4|Outcome|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to the face twice daily for 5 days. Includes participants treated with Vehicle in any of the randomized treatment groups.
196592|NCT01579084|O3|Outcome|AGN-199201 Formulation C|AGN-199201 Formulation C applied to the face twice daily for 5 days. Includes participants treated with Formulation C in any of the randomized treatment groups.
196593|NCT01579084|O2|Outcome|AGN-199201 Formulation B|AGN-199201 Formulation B applied to the face twice daily for 5 days. Includes participants treated with Formulation B in any of the randomized treatment groups.
196594|NCT01579084|O1|Outcome|AGN-199201 Formulation A|AGN-199201 Formulation A applied to the face twice daily for 5 days. Includes participants treated with Formulation A in any of the randomized treatment groups.
196595|NCT01579084|O4|Outcome|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to the face twice daily for 5 days. Includes participants treated with Vehicle in any of the randomized treatment groups.
196596|NCT01579084|O3|Outcome|AGN-199201 Formulation C|AGN-199201 Formulation C applied to the face twice daily for 5 days. Includes participants treated with Formulation C in any of the randomized treatment groups.
196597|NCT01579084|O2|Outcome|AGN-199201 Formulation B|AGN-199201 Formulation B applied to the face twice daily for 5 days. Includes participants treated with Formulation B in any of the randomized treatment groups.
196598|NCT01579084|O1|Outcome|AGN-199201 Formulation A|AGN-199201 Formulation A applied to the face twice daily for 5 days. Includes participants treated with Formulation A in any of the randomized treatment groups.
196599|NCT01579084|E10|Reported Event|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days.
196600|NCT01579084|E9|Reported Event|AGN-199201 Formulation C|AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days.
196601|NCT01579084|E8|Reported Event|AGN-199201 Formulation B|AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days.
196602|NCT01579084|E7|Reported Event|AGN-199201 Formulation A|AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days.
196603|NCT01579084|E6|Reported Event|AGN-199201 Formulation C and Vehicle|AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
196604|NCT01579084|E5|Reported Event|AGN-199201 Formulation B and Vehicle|AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
196605|NCT01579084|E4|Reported Event|AGN-199201 Formulation A and Vehicle|AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
196606|NCT01579084|E3|Reported Event|AGN-199201 Formulation C and A|AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily for 5 days.
196607|NCT01579084|E2|Reported Event|AGN-199201 Formulation B and C|AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily for 5 days.
196608|NCT01579084|E1|Reported Event|AGN-199201 Formulation A and B|AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily for 5 days.
196609|NCT01579045|B1|Baseline|Overall Subjects|All subjects who were enrolled, and completed the study.
196610|NCT01579045|P1|Participant Flow|All Subjects|All subjects who were enrolled.
196611|NCT01579045|O5|Outcome|Nelfilcon A (FDT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
196612|NCT01579045|O4|Outcome|Filcon II 3 (C1DT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
196613|NCT01579045|O3|Outcome|Etafilcon A (1DAMfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
196614|NCT01579045|O2|Outcome|Filcon II 3 (Sauflon)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
196615|NCT01579045|O1|Outcome|Senofilcon A (AOfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
196616|NCT01579045|O5|Outcome|Nelfilcon A (FDT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
196617|NCT01579045|O4|Outcome|Filcon II 3 (C1DT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
196618|NCT01579045|O3|Outcome|Etafilcon A (1DAMfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
196619|NCT01579045|O2|Outcome|Filcon II 3 (Sauflon)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
196620|NCT01579045|O1|Outcome|Senofilcon A (AOfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
196621|NCT01579045|E5|Reported Event|Nelfilcon A (FDT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
196622|NCT01579045|E4|Reported Event|Filcon II 3 (C1DT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
196623|NCT01579045|E3|Reported Event|Etafilcon A (1DAMfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
196624|NCT01579045|E2|Reported Event|Filcon II 3 (Sauflon)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
196625|NCT01579045|E1|Reported Event|Senofilcon A (AOfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
196708|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
196626|NCT01579006|B1|Baseline|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196627|NCT01579006|P1|Participant Flow|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), who have had an inadequate response (or were intolerant) to treatment with non-biological disease-modifying anti-rheumatic drugs (DMARDs) or with one biological agent in whom the attending physician decided to start treatment with tocilizumab (TCZ) (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196628|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196629|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196630|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196631|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196632|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196633|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196634|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196635|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196636|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196637|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196638|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196639|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196640|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196709|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
196710|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
196641|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196642|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196643|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196644|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196645|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196646|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196647|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196648|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196649|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196650|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196651|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196652|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196653|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196654|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196655|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196656|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196657|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196658|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196659|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196660|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196661|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196662|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196663|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
196664|NCT01579006|E1|Reported Event|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who had been receiving TCZ in the past and in whom the attending physician decided to start treatment with TCZ at the time of recruitment (according to the local label) were observed for 6 months.
196665|NCT01578993|B1|Baseline|Single Arm Study|Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.
196666|NCT01578993|P1|Participant Flow|Single Arm Study|Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.
196667|NCT01578993|O1|Outcome|Single Arm Study|Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.
196668|NCT01578993|E1|Reported Event|Single Arm Study|Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.
196669|NCT01578980|B1|Baseline|Outpatient Control-to-Range|"Outpatient Control-to-Range: Testing system connectivity~Outpatient Control-to-Range: Subjects will spend two nights (~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur."
196670|NCT01578980|P1|Participant Flow|Outpatient Control-to-Range|"Outpatient Control-to-Range: Testing system connectivity~Outpatient Control-to-Range: Subjects will spend two nights (~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur."
196671|NCT01578980|O1|Outcome|Outpatient Control-to-Range|"Outpatient Control-to-Range: Testing system connectivity~Outpatient Control-to-Range: Subjects will spend two nights (~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur.~42 hours total: 14 hours in open-loop 28 hours in closed-loop"
196672|NCT01578980|O1|Outcome|Outpatient Control-to-Range|"Outpatient Control-to-Range: Testing system connectivity~Outpatient Control-to-Range: Subjects will spend two nights (~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur.~42 hours total: 14 hours in open-loop 28 hours in closed-loop"
196673|NCT01578980|E1|Reported Event|Outpatient Control-to-Range|"Outpatient Control-to-Range: Testing system connectivity~Outpatient Control-to-Range: Subjects will spend two nights (~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur."
196674|NCT01578967|B1|Baseline|ABVD Followed by Brentuximab Vedotin|"Single arm trial~Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.~ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles."
196711|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
196712|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
196675|NCT01578967|P1|Participant Flow|ABVD Followed by Brentuximab Vedotin|"Single arm trial~Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.~ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles."
196676|NCT01578967|O3|Outcome|Grade 5|"Single arm trial~Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.~ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles."
196677|NCT01578967|O2|Outcome|Grade 4|"Single arm trial~Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.~ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles."
196678|NCT01578967|O1|Outcome|Grade 3|"Single arm trial~Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.~ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles."
196679|NCT01578967|O1|Outcome|ABVD Followed by Brentuximab Vedotin|"Single arm trial~Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.~ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles."
196680|NCT01578967|O1|Outcome|ABVD Followed by Brentuximab Vedotin|"Single arm trial~Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.~ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles."
196681|NCT01578967|O1|Outcome|ABVD Followed by Brentuximab Vedotin|"Single arm trial~Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.~ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles."
196682|NCT01578967|E1|Reported Event|ABVD Followed by Brentuximab Vedotin|"Single arm trial~Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.~ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles."
196683|NCT01578850|B3|Baseline|Total|Total of all reporting groups
196684|NCT01578850|B2|Baseline|Placebo|Participants were randomized to receive PBO 50 mg QW with MTX (with or without other DMARDs).
196685|NCT01578850|B1|Baseline|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
196686|NCT01578850|P3|Participant Flow|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
196687|NCT01578850|P2|Participant Flow|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
196688|NCT01578850|P1|Participant Flow|Open-Label Treatment|Participants in open-label treatment received Etanercept (ETN) 50 milligram (mg) once a week (QW) with MTX (with or without other DMARDs).
196689|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
196690|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
196691|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
196692|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
196693|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
196694|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
196695|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
196696|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
196697|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
196698|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
196699|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
196700|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
196701|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
196702|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
196703|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
196704|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
196705|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
196706|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
196707|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
198412|NCT01571453|O2|Outcome|Venlafaxine|Venlafaxine extended release: 150 mg/day
196714|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
196715|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
196716|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
196717|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
196718|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
196719|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
196720|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
196721|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
196722|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
196723|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
196724|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
196725|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
196726|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
196727|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
196728|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
196729|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
196730|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
196731|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
196732|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
196733|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
196734|NCT01578850|E3|Reported Event|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
196735|NCT01578850|E2|Reported Event|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
196736|NCT01578850|E1|Reported Event|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg with MTX (with or without other DMARDs).
196737|NCT01578785|B3|Baseline|Total|Total of all reporting groups
196738|NCT01578785|B2|Baseline|GA 20 mg/0.5 ml|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
196739|NCT01578785|B1|Baseline|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
196740|NCT01578785|P2|Participant Flow|GA 20 MG/0.5 ML|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
196741|NCT01578785|P1|Participant Flow|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
196742|NCT01578785|O2|Outcome|GA 20 MG/0.5 ML|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
196743|NCT01578785|O1|Outcome|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
196744|NCT01578785|O2|Outcome|GA 20 MG/0.5 ML|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
196745|NCT01578785|O1|Outcome|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
196746|NCT01578785|O2|Outcome|GA 20 MG/0.5 ML|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
196747|NCT01578785|O1|Outcome|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
196748|NCT01578785|O2|Outcome|GA 20 MG/0.5 ML|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
196749|NCT01578785|O1|Outcome|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
196750|NCT01578785|E2|Reported Event|Ga 20 mg/0.5 ml|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
196751|NCT01578785|E1|Reported Event|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
196752|NCT01578772|B1|Baseline|Telmisartan|"Open label~Telmisartan: 80mg tablets po daily for 6 weeks"
196753|NCT01578772|P1|Participant Flow|Telmisartan|"Open label~Telmisartan: 80mg tablets po daily for 6 weeks"
196754|NCT01578772|O2|Outcome|Week 6|All participants received telmisartan 80mg tablets po daily for 6 weeks. Flow-mediated dilatation (FMD) testing was performed for all participants at baseline (week 0) and 6 weeks.
196755|NCT01578772|O1|Outcome|Baseline (Week 0)|All participants received telmisartan 80mg tablets po daily for 6 weeks. Flow-mediated dilatation (FMD) testing was performed for all participants at baseline (week 0) and 6 weeks.
196756|NCT01578772|O2|Outcome|Week 6|All participants received telmisartan 80mg tablets po daily for 6 weeks. Flow-mediated dilatation (FMD) testing was performed for all participants at baseline (week 0) and 6 weeks.
196757|NCT01578772|O1|Outcome|Baseline (Week 0)|All participants received telmisartan 80mg tablets po daily for 6 weeks. Flow-mediated dilatation (FMD) testing was performed for all participants at baseline (week 0) and 6 weeks.
196758|NCT01578772|E1|Reported Event|Telmisartan|"Open label~Telmisartan: 80mg tablets po daily for 6 weeks"
196759|NCT01578707|B3|Baseline|Total|Total of all reporting groups
196760|NCT01578707|B2|Baseline|Ibrutinib (Arm B)|"A Bruton Tyrosine Kinase Inhibitor~ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity"
196868|NCT01577758|B1|Baseline|All Participants|All participants who participated in the Dose Escalation and mCRC Expansion Phases.
196761|NCT01578707|B1|Baseline|Ofatumumab (Arm A)|"An anti-CD20 monoclonal antibody~ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.~Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)"
196762|NCT01578707|P2|Participant Flow|Ibrutinib (Arm B)|"A Bruton Tyrosine Kinase Inhibitor~ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity"
196763|NCT01578707|P1|Participant Flow|Ofatumumab (Arm A)|"An anti-CD20 monoclonal antibody~ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.~Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)"
196764|NCT01578707|O2|Outcome|Ibrutinib (Arm B)|"A Bruton Tyrosine Kinase Inhibitor~ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity"
196765|NCT01578707|O1|Outcome|Ofatumumab (Arm A)|"An anti-CD20 monoclonal antibody~ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.~Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)"
196766|NCT01578707|O2|Outcome|Ibrutinib (Arm B)|"A Bruton Tyrosine Kinase Inhibitor~ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity"
196767|NCT01578707|O1|Outcome|Ofatumumab (Arm A)|"An anti-CD20 monoclonal antibody~ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.~Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)"
196768|NCT01578707|E2|Reported Event|Ibrutinib (Arm B)|"A Bruton Tyrosine Kinase Inhibitor~ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity"
196769|NCT01578707|E1|Reported Event|Ofatumumab (Arm A)|"An anti-CD20 monoclonal antibody~ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.~Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)"
196770|NCT01578499|B3|Baseline|Total|Total of all reporting groups
196771|NCT01578499|B2|Baseline|Methotrexate or Bexarotene|Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
196772|NCT01578499|B1|Baseline|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
196773|NCT01578499|P2|Participant Flow|Methotrexate or Bexarotene|Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
196774|NCT01578499|P1|Participant Flow|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
196775|NCT01578499|O2|Outcome|Methotrexate or Bexarotene|Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
196776|NCT01578499|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
196777|NCT01578499|O2|Outcome|Methotrexate or Bexarotene|Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
196778|NCT01578499|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
196779|NCT01578499|O2|Outcome|Methotrexate or Bexarotene|Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
196780|NCT01578499|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
196781|NCT01578499|O2|Outcome|MF: Brentuximab Vedotin 1.8 mg/kg|Participants with MF received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
196782|NCT01578499|O1|Outcome|pcALCL: Brentuximab Vedotin|Participants with pcALCL received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
196783|NCT01578499|O2|Outcome|MF: Brentuximab Vedotin 1.8 mg/kg|Participants with MF received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
196784|NCT01578499|O1|Outcome|pcALCL: Brentuximab Vedotin|Participants with pcALCL received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
196785|NCT01578499|O2|Outcome|MF: Brentuximab Vedotin 1.8 mg/kg|Participants with MF received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
196786|NCT01578499|O1|Outcome|pcALCL: Brentuximab Vedotin|Participants with pcALCL received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
196787|NCT01578499|O2|Outcome|MF: Brentuximab Vedotin 1.8 mg/kg|Participants with MF received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
203400|NCT01553318|E2|Reported Event|Placebo|received placebo
196788|NCT01578499|O1|Outcome|pcALCL: Brentuximab Vedotin|Participants with pcALCL received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
196789|NCT01578499|O2|Outcome|MF: Brentuximab Vedotin 1.8 mg/kg|Participants with mycosis fungoides (MF) received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
196790|NCT01578499|O1|Outcome|pcALCL: Brentuximab Vedotin|Participants with primary cutaneous anaplastic large cell lymphoma (pcALCL) received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
196791|NCT01578499|O2|Outcome|Methotrexate or Bexarotene|Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
196792|NCT01578499|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
196793|NCT01578499|O2|Outcome|Methotrexate or Bexarotene|Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
196794|NCT01578499|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
196795|NCT01578499|O2|Outcome|Methotrexate or Bexarotene|Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
196796|NCT01578499|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
196797|NCT01578499|O2|Outcome|Methotrexate or Bexarotene|Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
196798|NCT01578499|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
196799|NCT01578499|O2|Outcome|Methotrexate or Bexarotene|Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
196800|NCT01578499|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
196801|NCT01578499|O2|Outcome|Methotrexate or Bexarotene|Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
196802|NCT01578499|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
196803|NCT01578499|O2|Outcome|Methotrexate or Bexarotene|Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
196804|NCT01578499|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
196805|NCT01578499|E2|Reported Event|Methotrexate or Bexarotene|Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
196806|NCT01578499|E1|Reported Event|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
196807|NCT01578486|B1|Baseline|Salsalate|salsalate: open-label trial of salsalate 3g/day for 12 weeks.
196808|NCT01578486|P1|Participant Flow|Salsalate|salsalate: open-label trial of salsalate 3g/day for 12 weeks.
196809|NCT01578486|O1|Outcome|Salsalate|salsalate: open-label trial of salsalate 3g/day for 12 weeks.
196810|NCT01578486|O1|Outcome|Salsalate|salsalate: open-label trial of salsalate 3g/day for 12 weeks.
196811|NCT01578486|O1|Outcome|Salsalate|salsalate: open-label trial of salsalate 3g/day for 12 weeks.
196812|NCT01578486|O1|Outcome|Salsalate|salsalate: open-label trial of salsalate 3g/day for 12 weeks.
196813|NCT01578486|O1|Outcome|Salsalate|salsalate: open-label trial of salsalate 3g/day for 12 weeks.
196814|NCT01578486|O1|Outcome|Salsalate|salsalate: open-label trial of salsalate 3g/day for 12 weeks.
196815|NCT01578486|O1|Outcome|Salsalate|salsalate: open-label trial of salsalate 3g/day for 12 weeks.
196816|NCT01578486|O1|Outcome|Salsalate|salsalate: open-label trial of salsalate 3g/day for 12 weeks.
196817|NCT01578486|E1|Reported Event|Salsalate|salsalate: open-label trial of salsalate 3g/day for 12 weeks.
196818|NCT01578330|B1|Baseline|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
196819|NCT01578330|P1|Participant Flow|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
196820|NCT01578330|O1|Outcome|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
196821|NCT01578330|O1|Outcome|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
196822|NCT01578330|O1|Outcome|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
196823|NCT01578330|O1|Outcome|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
196824|NCT01578330|E1|Reported Event|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
196825|NCT01578239|B3|Baseline|Total|Total of all reporting groups
196826|NCT01578239|B2|Baseline|Octreotide LAR|"60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the patient progresses or dies (see Dose Modifying Toxicity (DMT));~In case patients experience clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections are allowed."
196827|NCT01578239|B1|Baseline|177Lu-DOTA0-Tyr3-Octreotate|"Cumulative dose of 29.6 GBq (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate delivered over 4 doses~Dosing regimen:~4 doses of 7.4 GBq (200 mCi) 177Lu-DOTA0-Tyr3-Octreotate administered in 8±1-week intervals. Intervals could be extended up to 16 weeks to accommodate resolving acute toxicity (see Dose Modifying Toxicity (DMT) below)~amino acids will be given with each administration for kidney protection;~Patients experiencing clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, were given 30 mg Octreotide LAR s.c. rescue injections for symptom control purpose, unless the patient progresses or dies."
196828|NCT01578239|P2|Participant Flow|Octreotide LAR|"60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the patient progresses or dies (see Dose Modifying Toxicity (DMT));~In case patients experience clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections are allowed."
196829|NCT01578239|P1|Participant Flow|177Lu-DOTA0-Tyr3-Octreotate|"Cumulative dose of 29.6 GBq (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate delivered over 4 doses~Dosing regimen:~4 doses of 7.4 GBq (200 mCi) 177Lu-DOTA0-Tyr3-Octreotate administered in 8±1-week intervals. Intervals could be extended up to 16 weeks to accommodate resolving acute toxicity (see Dose Modifying Toxicity (DMT) below)~amino acids will be given with each administration for kidney protection;~Patients experiencing clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, were given 30 mg Octreotide LAR s.c. rescue injections for symptom control purpose, unless the patient progresses or dies."
196830|NCT01578239|O2|Outcome|Octreotide LAR|
196831|NCT01578239|O1|Outcome|177Lu-DOTA0-Tyr3-Octreotate|
196832|NCT01578239|E2|Reported Event|Octreotide LAR|
196833|NCT01578239|E1|Reported Event|177Lu-DOTA0-Tyr3-Octreotate|
196834|NCT01578187|B1|Baseline|Hair2Go Device|The subjects who participated in the label comprehension phase, of them most participated in the usability phase. The subjects included all skin types and a population of low health literacy subjects based on the Rapid Estimate of Adult Literacy in Medicine (REALM)test.
196835|NCT01578187|P1|Participant Flow|Hair2Go Device|"This group included subjects who participated in the label comprehension phase. From these subjects, 48 subjects self-included in the usability phase (no contraindications) and chose to use the device for 1 treatment.~The subjects included all skin types and a population of low health literacy subjects based on the Rapid Estimate of Adult Literacy in Medicine (REALM) test."
196836|NCT01578187|O2|Outcome|Usability - Non Critical Error|Non critical error: An error that, if repeated without correction/intervention, may cause an adverse event.
196837|NCT01578187|O1|Outcome|Usability - Critical Error|Critical error: an error that may cause a serious adverse event or an adverse event from a single occurrence
196838|NCT01578187|O1|Outcome|Label Comprehension Group|Subjects that participated in the label comprehension phase of the study
196839|NCT01578187|E1|Reported Event|Hair2Go (Me) Device|The subjects who participated in the label comprehension phase; the majority of whom participated in the usability phase. The subjects included all skin types and a population of low health literacy subjects based on the Rapid Estimate of Adult Literacy in Medicine (REALM)test.
196840|NCT01578044|B3|Baseline|Total|Total of all reporting groups
196841|NCT01578044|B2|Baseline|Usual Care Group|"Usual care~Usual care patients will receive information on dabigatran, apixaban, and rivaroxaban including risks, benefits and potential side effects.~Following the end of the study, the usual care patients will receive the additional educational materials the intervention group received during the study."
196842|NCT01578044|B1|Baseline|Intervention Group|"Patients who are randomized to the intervention group will receive the following:~Patient education: Patients will receive information on dabigatran, apixaban, and rivaroxaban, including risks, benefits and potential side effects. This information will be re-enforced during the study on a monthly basis during the IVR calls and during the pharmacy service calls to patients.~Tele-monitoring: IVR technology will be used to send patients automated reminders to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each anticoagulant prescription.~Pharmacy follow-up: If the anticoagulant has not been refilled, the pharmacy staff will contact the patient to assess reasons the patient has not refilled the medication."
196843|NCT01578044|P2|Participant Flow|Usual Care|"Usual care patients will receive information on dabigatran, apixaban, and rivaroxaban including risks, benefits and potential side effects.~Following the end of the study, the usual care patients will receive the additional educational materials the intervention group received during the study."
196844|NCT01578044|P1|Participant Flow|Intervention Group|"Intervention patients will receive the following:~Patient education: All patients will receive information on their oral anticoagulant, including risks, benefits, and potential side effects. Intervention patients will receive additional materials at the beginning of the study through the mail.~Tele-monitoring: IVR technology will be used to send patients automated reminders to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each anticoagulant prescription.~Pharmacists follow-up: If dabigatran, rivaroxaban, and apixaban has not been refilled, the pharmacy staff will contact the patient to assess reasons that the patient has not refilled the medication."
196845|NCT01578044|O2|Outcome|Usual Care Group|All usual care patients will receive information on dabigatran, rivaroxaban, and apixaban, including risks, benefits, and potential side effects. Additionally, following their time in the study, the usual care patients will receive the additional educational materials the usual care received.
196846|NCT01578044|O1|Outcome|Intervention Group|"Patient education: Patients will receive information on dabigatran, including risks, benefits and potential side effects. This information will be re-enforced during the study on a monthly basis during the IVR calls and during the pharmacy service calls to patients.~Tele-monitoring: We will use IVR technology to send patients an automated reminder to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each dabigatran, rivaroxaban, and apixaban prescription.~Pharmacists follow-up: If dabigatran, rivaroxaban, and apixaban has not been refilled, the pharmacy staff will contact the patient to assess reasons that the patient has not refilled the medication."
204699|NCT01546883|O1|Outcome|Dabigatran|Dabigatran
196847|NCT01578044|E2|Reported Event|Usual Care Group|"Usual care~All patients will receive information on dabigatran, rivaroxaban, and apixaban, including risks, benefits, and potential side effects. Also, following their enrollment in the study will receive the additional educational materials given to the intervention group during their time in the study."
196848|NCT01578044|E1|Reported Event|Intervention Group|"Patient education: Patients will receive information on dabigatran, including risks, benefits and potential side effects. This information will be re-enforced during the study on a monthly basis during the IVR calls and during the pharmacy service calls to patients.~Tele-monitoring: We will use IVR technology to send patients an automated reminder to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each dabigatran, rivaroxaban, and apixaban prescription.~Pharmacists follow-up: If dabigatran, rivaroxaban, and apixaban has not been refilled, the pharmacy staff will contact the patient to assess reasons that the patient has not refilled the medication."
196849|NCT01578031|B5|Baseline|Total|Total of all reporting groups
196850|NCT01578031|B4|Baseline|Non-obese Subjects Without OSA|"Control.~Usual Care: Usual care."
196851|NCT01578031|B3|Baseline|Obese Subjects Without OSA|"Control.~Usual Care: Usual care."
196852|NCT01578031|B2|Baseline|Non-obese Patients With Obstructive Sleep Apnea|"Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.~Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
196853|NCT01578031|B1|Baseline|Obese Patients With Obstructive Sleep Apnea|"Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.~Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
196854|NCT01578031|P4|Participant Flow|Non-obese Subjects Without OSA|"Control.~Usual Care: Usual care."
196855|NCT01578031|P3|Participant Flow|Obese Subjects Without OSA|"Control.~Usual Care: Usual care."
196856|NCT01578031|P2|Participant Flow|Non-obese Patients With Obstructive Sleep Apnea|"Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.~Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
196857|NCT01578031|P1|Participant Flow|Obese Patients With Obstructive Sleep Apnea|"Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.~Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
196858|NCT01578031|O2|Outcome|Non-obese Patients With Obstructive Sleep Apnea|"Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.~Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
196859|NCT01578031|O1|Outcome|Obese Patients With Obstructive Sleep Apnea|"Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.~Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
196860|NCT01578031|E4|Reported Event|Non-obese Patients Without Sleep Apnea|Control Non-obese adults between the 40 and 65 years of age without OSA as evidenced by an apnea/hypopnea index < 15
196861|NCT01578031|E3|Reported Event|Obese Patients Without Sleep Apnea|Control Obese adults between the 40 and 65 years of age without OSA as evidenced by an apnea/hypopnea index < 15
196862|NCT01578031|E2|Reported Event|Non-obese Patients With Obstructive Sleep Apnea|"Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.~Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
196863|NCT01578031|E1|Reported Event|Obese Patients With Obstructive Sleep Apnea|"Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.~Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
196864|NCT01577966|B1|Baseline|Sulfasalazine|"Sulfasalazine: Sulfasalazine has been the parent aminosalicylate in use for over 40 years in the treatment of inflammatory bowel disease. The drug is a conjugate of sulfapyridine linked to 5-aminosalicylic acid. In inflammatory bowel disease, the 5-ASA component is the active moiety~Sulfasalazine is a prodrug that consists of sulfapyridine bonded to mesalamine (5-ASA). Sulfasalazine is cleaved by colonic bacterial azo-reductases into sulfapyridine and the 5-ASA moiety. 5-ASA is metabolized to N-acetyl-5-ASA by an enzyme in the intestinal epithelium and the liver and then excreted in the urine as a mixture of free 5ASA and N-acetyl-5-ASA."
196865|NCT01577966|P1|Participant Flow|Sulfasalazine|Sulfasalazine
196866|NCT01577966|O1|Outcome|Sulfasalazine|"Sulfasalazine: Sulfasalazine has been the parent aminosalicylate in use for over 40 years in the treatment of inflammatory bowel disease. The drug is a conjugate of sulfapyridine linked to 5-aminosalicylic acid. In inflammatory bowel disease, the 5-ASA component is the active moiety~Sulfasalazine is a prodrug that consists of sulfapyridine bonded to mesalamine (5-ASA). Sulfasalazine is cleaved by colonic bacterial azo-reductases into sulfapyridine and the 5-ASA moiety. 5-ASA is metabolized to N-acetyl-5-ASA by an enzyme in the intestinal epithelium and the liver and then excreted in the urine as a mixture of free 5ASA and N-acetyl-5-ASA."
196867|NCT01577966|E1|Reported Event|Sulfasalazine|"Sulfasalazine: Sulfasalazine has been the parent aminosalicylate in use for over 40 years in the treatment of inflammatory bowel disease. The drug is a conjugate of sulfapyridine linked to 5-aminosalicylic acid. In inflammatory bowel disease, the 5-ASA component is the active moiety~Sulfasalazine is a prodrug that consists of sulfapyridine bonded to mesalamine (5-ASA). Sulfasalazine is cleaved by colonic bacterial azo-reductases into sulfapyridine and the 5-ASA moiety. 5-ASA is metabolized to N-acetyl-5-ASA by an enzyme in the intestinal epithelium and the liver and then excreted in the urine as a mixture of free 5ASA and N-acetyl-5-ASA."
204700|NCT01546883|E1|Reported Event|Dabigatran|Patients taking Dabigatran
196869|NCT01577758|P8|Participant Flow|MLN0264 1.8 mg/kg (mCRC Expansion)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
196870|NCT01577758|P7|Participant Flow|MLN0264 2.4 mg/kg|MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196871|NCT01577758|P6|Participant Flow|MLN0264 2.1 mg/kg|MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196872|NCT01577758|P5|Participant Flow|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196873|NCT01577758|P4|Participant Flow|MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196874|NCT01577758|P3|Participant Flow|MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196875|NCT01577758|P2|Participant Flow|MLN0264 0.6 mg/kg|MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196876|NCT01577758|P1|Participant Flow|MLN0264 0.3 mg/kg|MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196877|NCT01577758|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196878|NCT01577758|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196879|NCT01577758|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196880|NCT01577758|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196881|NCT01577758|O8|Outcome|MLN0264 1.8 mg/kg (mCRC Expansion)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
196882|NCT01577758|O7|Outcome|MLN0264 2.4 mg/kg|MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196883|NCT01577758|O6|Outcome|MLN0264 2.1 mg/kg|MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196884|NCT01577758|O5|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196885|NCT01577758|O4|Outcome|MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196886|NCT01577758|O3|Outcome|MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196887|NCT01577758|O2|Outcome|MLN0264 0.6 mg/kg|MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196888|NCT01577758|O1|Outcome|MLN0264 0.3 mg/kg|MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196889|NCT01577758|O2|Outcome|MLN0264 1.8 mg/kg (mCRC Expansion)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
196890|NCT01577758|O1|Outcome|MLN0264 Dose Escalation Phase|MLN0264 0.3 to 2.4 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in the dose escalation phase.
196891|NCT01577758|O1|Outcome|MLN0264 Dose Escalation Phase|MLN0264 0.3 to 2.4 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in the dose escalation phase.
196892|NCT01577758|O2|Outcome|MLN0264 1.8 mg/kg (mCRC Expansion)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
196893|NCT01577758|O1|Outcome|MLN0264 Dose Escalation Phase|MLN0264 0.3 to 2.4 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in the dose escalation phase.
196894|NCT01577758|O7|Outcome|MLN0264 2.4 mg/kg|MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196895|NCT01577758|O6|Outcome|MLN0264 2.1 mg/kg|MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196896|NCT01577758|O5|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196897|NCT01577758|O4|Outcome|MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196898|NCT01577758|O3|Outcome|MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196899|NCT01577758|O2|Outcome|MLN0264 0.6 mg/kg|MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196900|NCT01577758|O1|Outcome|MLN0264 0.3 mg/kg|MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196901|NCT01577758|E7|Reported Event|MLN0264 2.4 mg/kg|MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196902|NCT01577758|E6|Reported Event|MLN0264 2.1 mg/kg|MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196903|NCT01577758|E5|Reported Event|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196904|NCT01577758|E4|Reported Event|MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196905|NCT01577758|E3|Reported Event|MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196906|NCT01577758|E2|Reported Event|MLN0264 0.6 mg/kg|MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196907|NCT01577758|E1|Reported Event|MLN0264 0.3 mg/kg|MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
196908|NCT01577745|B7|Baseline|Total|Total of all reporting groups
196909|NCT01577745|B6|Baseline|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21 day cycle.
196910|NCT01577745|B5|Baseline|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196911|NCT01577745|B4|Baseline|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196912|NCT01577745|B3|Baseline|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196913|NCT01577745|B2|Baseline|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196914|NCT01577745|B1|Baseline|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196915|NCT01577745|P6|Participant Flow|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21 day cycle.
196916|NCT01577745|P5|Participant Flow|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196917|NCT01577745|P4|Participant Flow|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196918|NCT01577745|P3|Participant Flow|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196919|NCT01577745|P2|Participant Flow|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196920|NCT01577745|P1|Participant Flow|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute intravenous (IV) infusion on Day 1 of each 21-day cycle.
196921|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196922|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196923|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196924|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196925|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196926|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196927|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196928|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196929|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196930|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196931|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196932|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196933|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196934|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196935|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196936|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196937|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196938|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196939|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196940|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196941|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196942|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196943|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196944|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
198413|NCT01571453|O1|Outcome|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
196945|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196946|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196947|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196948|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196949|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196950|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196951|NCT01577745|O6|Outcome|MMEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196952|NCT01577745|O5|Outcome|MMEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196953|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle..
196954|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196955|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196956|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196957|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196958|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196959|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196960|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196961|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196962|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196963|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196964|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196965|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196966|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196967|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196968|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196969|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196970|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196971|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196972|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196973|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196974|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196975|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196976|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196977|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196978|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196979|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196980|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196981|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196982|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196983|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196984|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196985|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196986|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196987|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196988|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196989|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196990|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196991|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196992|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196993|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196994|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196995|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196996|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196997|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196998|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
196999|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197000|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197001|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197002|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197003|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197004|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197005|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197006|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197007|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197008|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197009|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197010|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197011|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197012|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197013|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197014|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197015|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197016|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197017|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197018|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197019|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197020|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197021|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197022|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197023|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21 day cycle.
197024|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197025|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197026|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197027|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197028|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197029|NCT01577745|O1|Outcome|MEDI0639|Participants received MEDI0639, in dose escalation phase starting from dose level 1 to 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197030|NCT01577745|E6|Reported Event|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21 day cycle.
197031|NCT01577745|E5|Reported Event|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197032|NCT01577745|E4|Reported Event|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197033|NCT01577745|E3|Reported Event|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197461|NCT01576159|E2|Reported Event|Moderate-Impact Loading|Performed moderate-impact cycling exercise during intervention period.
197034|NCT01577745|E2|Reported Event|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197035|NCT01577745|E1|Reported Event|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
197036|NCT01577732|B1|Baseline|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
197037|NCT01577732|P1|Participant Flow|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
197038|NCT01577732|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
197039|NCT01577732|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
197040|NCT01577732|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
197041|NCT01577732|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
197042|NCT01577732|E1|Reported Event|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
197043|NCT01577706|B1|Baseline|All Study Participants|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day~Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
197044|NCT01577706|P3|Participant Flow|Placebo, Dextroamphetamine, Alprazolam Sequence|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day~Placebo: single-dose, 1-day"
197045|NCT01577706|P2|Participant Flow|Alprazolam, Dextroamphetamine, Placebo Sequence|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day~Placebo: single-dose, 1-day"
197046|NCT01577706|P1|Participant Flow|Dextroamphetamine, Alprazolam, Placebo Sequence|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day~Placebo: single-dose, 1-day"
197047|NCT01577706|O3|Outcome|Dextroamphetamine|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
197048|NCT01577706|O2|Outcome|Alprazolam|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day"
197049|NCT01577706|O1|Outcome|Placebo|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Placebo: single-dose, 1-day"
197050|NCT01577706|O3|Outcome|Dextroamphetamine|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
197051|NCT01577706|O2|Outcome|Alprazolam|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day"
197052|NCT01577706|O1|Outcome|Placebo|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Placebo: single-dose, 1-day"
197053|NCT01577706|O3|Outcome|Dextroamphetamine|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
197054|NCT01577706|O2|Outcome|Alprazolam|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day"
197055|NCT01577706|O1|Outcome|Placebo|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Placebo: single-dose, 1-day"
197056|NCT01577706|O3|Outcome|Dextroamphetamine|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
197057|NCT01577706|O2|Outcome|Alprazolam|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day"
197058|NCT01577706|O1|Outcome|Placebo|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Placebo: single-dose, 1-day"
197059|NCT01577706|O3|Outcome|Dextroamphetamine|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
197060|NCT01577706|O2|Outcome|Alprazolam|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day"
197061|NCT01577706|O1|Outcome|Placebo|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Placebo: single-dose, 1-day"
197062|NCT01577706|O3|Outcome|Dextroamphetamine|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
197063|NCT01577706|O2|Outcome|Alprazolam|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day"
197064|NCT01577706|O1|Outcome|Placebo|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Placebo: single-dose, 1-day"
197065|NCT01577706|O3|Outcome|Dextroamphetamine|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
197066|NCT01577706|O2|Outcome|Alprazolam|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day"
197067|NCT01577706|O1|Outcome|Placebo|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Placebo: single-dose, 1-day"
197068|NCT01577706|E3|Reported Event|Placebo|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Placebo, single-dose, 1-day"
198414|NCT01571453|O2|Outcome|Venlafaxine|Venlafaxine extended release: 150 mg/day
197069|NCT01577706|E2|Reported Event|Dextroamphetamine|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
197070|NCT01577706|E1|Reported Event|Alprazolam|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day"
197071|NCT01577628|B3|Baseline|Total|Total of all reporting groups
197072|NCT01577628|B2|Baseline|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
197073|NCT01577628|B1|Baseline|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
197074|NCT01577628|P3|Participant Flow|Screen Only|Subject was not randomized to either treatment prior to study termination.
197075|NCT01577628|P2|Participant Flow|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
197076|NCT01577628|P1|Participant Flow|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
197077|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
197078|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
197079|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
197080|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
197081|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
197082|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
197083|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
197084|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
197085|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
197086|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
197087|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
197088|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
197089|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
197090|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
197091|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
197092|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
197093|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
197094|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
197095|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
197096|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
197097|NCT01577628|E2|Reported Event|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
197098|NCT01577628|E1|Reported Event|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
197099|NCT01577381|B5|Baseline|Total|Total of all reporting groups
197100|NCT01577381|B4|Baseline|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197101|NCT01577381|B3|Baseline|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197102|NCT01577381|B2|Baseline|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197103|NCT01577381|B1|Baseline|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197104|NCT01577381|P4|Participant Flow|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197105|NCT01577381|P3|Participant Flow|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197106|NCT01577381|P2|Participant Flow|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197107|NCT01577381|P1|Participant Flow|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197108|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197109|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197110|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197111|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197112|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197113|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197114|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197115|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197116|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197117|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197118|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197119|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197120|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197121|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197122|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197123|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197124|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197125|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197126|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197127|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197128|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197129|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197130|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197131|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197132|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197133|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197134|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197135|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197136|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197137|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197138|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197139|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197140|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197141|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197142|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197143|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197144|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197145|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197146|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197147|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197148|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197149|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197150|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197151|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197152|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197153|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197154|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197155|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197156|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197157|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197158|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197159|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197160|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197161|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197162|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197163|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197164|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197165|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197166|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197167|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197168|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197169|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197170|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197171|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197172|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197173|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197174|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197175|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197176|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197177|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197178|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197179|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197180|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197181|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197182|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197183|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197184|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197185|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197186|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197187|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197188|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197189|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197190|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197191|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197192|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
204701|NCT01546688|B3|Baseline|Total|Total of all reporting groups
197193|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197194|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197195|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197196|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197197|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197198|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197199|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197200|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197201|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197202|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197203|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197204|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197205|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197206|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197207|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197208|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197209|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197210|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197211|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197212|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197213|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197214|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197215|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197216|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197217|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197218|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197219|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197220|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197221|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197222|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197223|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197224|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197225|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197226|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197227|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197228|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197229|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197230|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197231|NCT01577381|E4|Reported Event|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
197232|NCT01577381|E3|Reported Event|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197233|NCT01577381|E2|Reported Event|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
197462|NCT01576159|E1|Reported Event|High-Impact Loading|Performed high-impact running exercise during intervention period.
197234|NCT01577381|E1|Reported Event|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
197235|NCT01577329|B3|Baseline|Total|Total of all reporting groups
197236|NCT01577329|B2|Baseline|Wait List|Subjects assigned to the control group will continue with medical treatment as usual and be allowed to attend the mindfulness meditation class after week eight.
197237|NCT01577329|B1|Baseline|Mindfulness Meditation Class|"Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned.~Mindfulness meditation: Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned."
197238|NCT01577329|P2|Participant Flow|Wait List|Subjects assigned to the control group will continue with medical treatment as usual and be allowed to attend the mindfulness meditation class after week eight.
197239|NCT01577329|P1|Participant Flow|Mindfulness Meditation Class|"Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned.~Mindfulness meditation: Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned."
197240|NCT01577329|O2|Outcome|Wait List|Subjects assigned to the control group will continue with medical treatment as usual and be allowed to attend the mindfulness meditation class after week eight.
197241|NCT01577329|O1|Outcome|Mindfulness Meditation Class|"Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned.~Mindfulness meditation: Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned."
197242|NCT01577329|E2|Reported Event|Wait List|Subjects assigned to the control group will continue with medical treatment as usual and be allowed to attend the mindfulness meditation class after week eight.
197243|NCT01577329|E1|Reported Event|Mindfulness Meditation Class|"Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned.~Mindfulness meditation: Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned."
197244|NCT01577186|B1|Baseline|Paliperidone ER|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12 as per Investigator’s discretion.
197245|NCT01577186|P1|Participant Flow|Paliperidone ER|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12 as per Investigator’s discretion.
197246|NCT01577186|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator’s discretion.
197247|NCT01577186|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator’s discretion.
197248|NCT01577186|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator’s discretion.
197249|NCT01577186|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator’s discretion.
197250|NCT01577186|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator’s discretion.
197251|NCT01577186|E1|Reported Event|Paliperidone ER|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12 as per Investigator’s discretion.
197252|NCT01577160|B1|Baseline|Paliperidone ER|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
197253|NCT01577160|P1|Participant Flow|Paliperidone ER|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s Clinical Global Impression - Improvement (CGI-I) score.
197254|NCT01577160|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
197255|NCT01577160|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
197256|NCT01577160|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
197257|NCT01577160|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
197258|NCT01577160|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
197259|NCT01577160|E1|Reported Event|Paliperidone ER|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
197260|NCT01577108|B3|Baseline|Total|Total of all reporting groups
198415|NCT01571453|O1|Outcome|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
197261|NCT01577108|B2|Baseline|Non-probiotics, GBS Test|"Treated with 2 placebo capsules once daily before sleeping for 14 days~GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days"
197262|NCT01577108|B1|Baseline|Probiotics, GBS Test|"Treated with 2 oral probiotics once daily before sleeping for 14 days~GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days"
197263|NCT01577108|P2|Participant Flow|Non-probiotics, GBS Test|"Treated with 2 placebo capsules once daily before sleeping for 14 days~GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days"
197264|NCT01577108|P1|Participant Flow|Probiotics, GBS Test|"Treated with 2 oral probiotics once daily before sleeping for 14 days~GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days"
197265|NCT01577108|O2|Outcome|Non-probiotics, GBS Test|"Treated with 2 placebo capsules once daily before sleeping for 14 days~GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days~Number of GBS-Positive pregnant women who became GBS-Negative at childbirth is 9 in the probiotic group (18.0%)."
197266|NCT01577108|O1|Outcome|Probiotics, GBS Test|"Treated with 2 oral probiotics once daily before sleeping for 14 days~GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days~Number of GBS-Positive pregnant women who became GBS-Negative at childbirth is 21 in the probiotic group (42.9%)."
197267|NCT01577108|E2|Reported Event|Non-probiotics, GBS Test|"Treated with 2 placebo capsules once daily before sleeping for 14 days~GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days"
197268|NCT01577108|E1|Reported Event|Probiotics, GBS Test|"Treated with 2 oral probiotics once daily before sleeping for 14 days~GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days"
197269|NCT01576952|B3|Baseline|Total|Total of all reporting groups
197270|NCT01576952|B2|Baseline|Vehicle|DuraSite vehicle dosed BID
197271|NCT01576952|B1|Baseline|ISV-303|0.075% bromfenac in DuraSite dosed BID
197272|NCT01576952|P2|Participant Flow|Vehicle|DuraSite vehicle dosed BID
197273|NCT01576952|P1|Participant Flow|ISV-303|0.075% bromfenac in DuraSite dosed BID
197274|NCT01576952|O2|Outcome|Vehicle|DuraSite vehicle dosed BID
197275|NCT01576952|O1|Outcome|ISV-303|0.075% bromfenac in DuraSite dosed BID
197276|NCT01576952|E2|Reported Event|Vehicle|DuraSite vehicle dosed BID
197277|NCT01576952|E1|Reported Event|ISV-303|0.075% bromfenac in DuraSite dosed BID
197278|NCT01576939|B1|Baseline|Intensity Modulated RT Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.~intensity modulated radiotherapy treatment"
197279|NCT01576939|P1|Participant Flow|Intensity Modulated Radiotherapy Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.~intensity modulated radiotherapy treatment"
197280|NCT01576939|O1|Outcome|Intensity Modulated Radiotherapy Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.~intensity modulated radiotherapy treatment"
197281|NCT01576939|O1|Outcome|Intensity Modulated Radiotherapy Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.~intensity modulated radiotherapy treatment"
197282|NCT01576939|O1|Outcome|Intensity Modulated Radiotherapy Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.~intensity modulated radiotherapy treatment"
197283|NCT01576939|O1|Outcome|Intensity Modulated Radiotherapy Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.~intensity modulated radiotherapy treatment"
197284|NCT01576939|O1|Outcome|Intensity Modulated Radiotherapy Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.~intensity modulated radiotherapy treatment"
197285|NCT01576939|E1|Reported Event|Intensity Modulated Radiotherapy Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.~intensity modulated radiotherapy treatment"
197286|NCT01576809|B1|Baseline|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
197287|NCT01576809|P1|Participant Flow|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
197288|NCT01576809|O1|Outcome|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
197289|NCT01576809|O1|Outcome|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
197290|NCT01576809|O1|Outcome|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
197291|NCT01576809|E1|Reported Event|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
197292|NCT01576718|B7|Baseline|Total|Total of all reporting groups
197293|NCT01576718|B6|Baseline|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197294|NCT01576718|B5|Baseline|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197343|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197295|NCT01576718|B4|Baseline|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197296|NCT01576718|B3|Baseline|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197297|NCT01576718|B2|Baseline|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197298|NCT01576718|B1|Baseline|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197299|NCT01576718|P7|Participant Flow|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197300|NCT01576718|P6|Participant Flow|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197301|NCT01576718|P5|Participant Flow|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197302|NCT01576718|P4|Participant Flow|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197303|NCT01576718|P3|Participant Flow|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197304|NCT01576718|P2|Participant Flow|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197305|NCT01576718|P1|Participant Flow|Placebo MDPI (Run-In)|Upon enrollment, participants used current asthma medications and 1 inhalation of placebo multidose dry powder inhaler (MDPI), single-blind, twice daily for 14-day (±2 days).
197306|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197307|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197308|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197309|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197310|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197459|NCT01576159|E4|Reported Event|Control Group|Didn't participate any organized physical exercises
205164|NCT01545700|O10|Outcome|Dexamethasone 4 mg 0-4 Hours-4 Hours|
197311|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197312|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197313|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197314|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197315|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197316|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197317|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197318|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197319|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197320|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197321|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197322|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197323|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197324|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197325|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197326|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
205165|NCT01545700|O9|Outcome|Dexamethasone 4 mg 0-4 Hours-3 Hours|
197327|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197328|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197329|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197330|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197331|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197332|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197333|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197334|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197335|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197336|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197337|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197338|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197339|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197340|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197341|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197342|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197344|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197345|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197346|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197347|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197348|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197349|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197350|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197351|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197352|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197353|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197354|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197355|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197356|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197357|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197358|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197359|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197360|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197361|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197362|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197363|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197364|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197365|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197366|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197367|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197368|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197369|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197370|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197371|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197372|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197373|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197374|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197375|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
205166|NCT01545700|O8|Outcome|Dexamethasone 4 mg 0-4 Hours-2 Hours|
197376|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197377|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197378|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197379|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197380|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197381|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197382|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197383|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197384|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197385|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197386|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197387|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197388|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197389|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197390|NCT01576718|E6|Reported Event|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197391|NCT01576718|E5|Reported Event|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
205167|NCT01545700|O7|Outcome|Dexamethasone 4 mg 0-4 Hours-1 Hour|
197392|NCT01576718|E4|Reported Event|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197393|NCT01576718|E3|Reported Event|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197394|NCT01576718|E2|Reported Event|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197395|NCT01576718|E1|Reported Event|Flovent Diskus 250 mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
197396|NCT01576549|B1|Baseline|LY2127399|Participants received 240 mg LY2127399 administered SC (2 SC injections of 120 mg) as a loading dose on Day 1.
197397|NCT01576549|P1|Participant Flow|LY2127399|"Participants received 240 milligrams (mg) LY2127399 administered subcutaneously (SC) (2 SC injections of 120 mg) as a loading dose on Day 1.~Follow-up visits occurred up to 24 weeks after the final injection of study drug."
197398|NCT01576549|O1|Outcome|LY2127399|Participants received 240 mg LY2127399 administered SC (2 SC injections of 120 mg) as a loading dose on Day 1.
197399|NCT01576549|O1|Outcome|LY2127399|Participants received 240 mg LY2127399 administered SC (2 SC injections of 120 mg) as a loading dose on Day 1.
197400|NCT01576549|O1|Outcome|LY2127399|Participants received 240 mg LY2127399 administered SC (2 SC injections of 120 mg) as a loading dose on Day 1.
197401|NCT01576549|O1|Outcome|LY2127399|Participants received 240 mg LY2127399 administered SC (2 SC injections of 120 mg) as a loading dose on Day 1.
197402|NCT01576549|E2|Reported Event|LY2127399 - Follow-up Period|"Participants received 240 mg LY2127399 administered SC (2 SC injections of 120 mg) as a loading dose on Day 1.~Participants then discontinued dosing as a result of study closure, but completed the Post-Treatment Follow-Up Period for up to 24 weeks after the final injection of study drug."
197403|NCT01576549|E1|Reported Event|LY2127399 - Treatment Period|Participants received 240 mg LY2127399 administered SC (2 SC injections of 120 mg) as a loading dose on Day 1.
197404|NCT01576471|B3|Baseline|Total|Total of all reporting groups
197405|NCT01576471|B2|Baseline|TSO 7500|Trichuris suis ova (TSO): TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)
197406|NCT01576471|B1|Baseline|Placebo|Placebo: Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)
197407|NCT01576471|P2|Participant Flow|TSO 7500|Trichuris suis ova (TSO): TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)
197408|NCT01576471|P1|Participant Flow|Placebo|Placebo: Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)
197409|NCT01576471|O2|Outcome|TSO 7500|Trichuris suis ova (TSO): TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)
197410|NCT01576471|O1|Outcome|Placebo|Placebo: Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)
197411|NCT01576471|E2|Reported Event|TSO 7500|Trichuris suis ova (TSO): TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)
197412|NCT01576471|E1|Reported Event|Placebo|Placebo: Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)
197413|NCT01576367|B1|Baseline|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
197414|NCT01576367|P1|Participant Flow|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
197415|NCT01576367|O1|Outcome|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
197416|NCT01576367|O1|Outcome|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
197417|NCT01576367|O1|Outcome|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
197418|NCT01576367|O1|Outcome|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
197419|NCT01576367|O1|Outcome|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
197460|NCT01576159|E3|Reported Event|Non-Impact Loading|Performed low-impact swimming exercise during intervention period.
205168|NCT01545700|O6|Outcome|Dexamethasone 4 mg 0-4 Hours-baseline|
197420|NCT01576367|E1|Reported Event|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
197421|NCT01576341|B1|Baseline|HX575, Safety Population|The Study was designed as single arm study with HX575 tested as investigational medicinal product. The safety population (SAF) consisted of all patients that received at least one dose of study drug. 417 patients enrolled, 416 treated. Group includes ESA-naïve patients and patients on ESA-maintenance therapy.
197422|NCT01576341|P1|Participant Flow|HX575, Safety Population|In the single arm study, HX575 was tested as investigational medicinal product. The single arm includes ESA-naïve patients and patients on ESA-maintenance therapy.
197423|NCT01576341|O3|Outcome|HX575|HX575 administered s.c. at least once per week. During the treatment period the dose was individually titrated to maintain hemoglobin levels between 10.0 and 12.0 g/dL.
197424|NCT01576341|O2|Outcome|HX575 - ESA Maintenance|HX575 administered s.c. at least once per week. During the treatment period the dose was individually titrated to maintain hemoglobin levels between 10.0 and 12.0 g/dL. At study start patients were either ESA (Erythropoiesis Stimulating Agent) naive or on ESA maintenance treatment. This group only contains patients that were on ESA maintenance treatment at study start, e.g. did receive at least one dose of commercial ESA treatment within 2 months prior to first screening visit.
197425|NCT01576341|O1|Outcome|HX575 - ESA Naive|HX575 administered s.c. at least once per week. During the treatment period the dose was individually titrated to maintain hemoglobin levels between 10.0 and 12.0 g/dL. At study start patients were either ESA (Erythropoiesis Stimulating Agent) naive or on ESA maintenance treatment. This group only contains patients that were ESA naive at study start, e.g. did not receive any ESA dose within 2 months prior to first screening visit.
197426|NCT01576341|O1|Outcome|HX575|HX575 administered s.c. at least once per week. During the treatment period the dose was individually titrated to maintain hemoglobin levels between 10.0 and 12.0 g/dL
197427|NCT01576341|E1|Reported Event|HX575, Safety Population|Study was designed as single arm study with HX575 tested as investigational medicinal product. Safety population includes ESA therapy naïve patients and ESA maintenance patients. Shown are all AEs including non-treatment related AEs.
197428|NCT01576276|B3|Baseline|Total|Total of all reporting groups
197429|NCT01576276|B2|Baseline|Ketorolac Condition|"Integrated MR-PET scan: Integrated MR-PET scan using [11C]diprenorphine~Ketorolac: 3 administrations of ketorolac over course of study"
197430|NCT01576276|B1|Baseline|Morphine Condition|"Integrated MR-PET scan: Integrated MR-PET scan using [11C]diprenorphine~Morphine: 3 administrations of morphine over course of study"
197431|NCT01576276|P2|Participant Flow|Ketorolac Condition|"Integrated MR-PET scan: Integrated MR-PET scan using [11C]diprenorphine~Ketorolac: 3 administrations of ketorolac over course of study"
197432|NCT01576276|P1|Participant Flow|Morphine Condition|"Integrated MR-PET scan: Integrated MR-PET scan using [11C]diprenorphine~Morphine: 3 administrations of morphine over course of study"
197433|NCT01576276|O2|Outcome|Ketorolac Condition|"Integrated MR-PET scan: Integrated MR-PET scan using [11C]diprenorphine~Ketorolac: 3 administrations of ketorolac over course of study"
197434|NCT01576276|O1|Outcome|Morphine Condition|"Integrated MR-PET scan: Integrated MR-PET scan using [11C]diprenorphine~Morphine: 3 administrations of morphine over course of study"
197435|NCT01576276|O1|Outcome|fMRI Signal Change|We used SPM 12 to analyze the data, and compared the fMRI signal change during pressure pain between 1. morphine injection cue vs. control cue, 2. ketorolac injection cue vs. control cue. A threshold of p < 0.005 with 10 continuous voxels was applied.
197436|NCT01576276|E2|Reported Event|Ketorolac Condition|"Integrated MR-PET scan: Integrated MR-PET scan using [11C]diprenorphine~Ketorolac: 3 administrations of ketorolac over course of study"
197437|NCT01576276|E1|Reported Event|Morphine Condition|"Integrated MR-PET scan: Integrated MR-PET scan using [11C]diprenorphine~Morphine: 3 administrations of morphine over course of study"
197438|NCT01576159|B5|Baseline|Total|Total of all reporting groups
197439|NCT01576159|B4|Baseline|Control Group|Didn't participate any organized physical exercises
197440|NCT01576159|B3|Baseline|Non-Impact Loading|Performed low-impact swimming exercise during intervention period.
197441|NCT01576159|B2|Baseline|Moderate-Impact Loading|Performed moderate-impact cycling exercise during intervention period.
197442|NCT01576159|B1|Baseline|High-Impact Loading|Performed high-impact running exercise during intervention period.
197443|NCT01576159|P4|Participant Flow|Control Group|Didn't participate any organized physical exercises
197444|NCT01576159|P3|Participant Flow|Non-Impact Loading|Performed low-impact swimming exercise during intervention period.
197445|NCT01576159|P2|Participant Flow|Moderate-Impact Loading|Performed moderate-impact cycling exercise during intervention period.
197446|NCT01576159|P1|Participant Flow|High-Impact Loading|Performed high-impact running exercise during intervention period.
197447|NCT01576159|O4|Outcome|Control Group|Not Participated any organized physical exercise
197448|NCT01576159|O3|Outcome|Non-Impact Loading|Performed Non-impact swimming exercise for 12 weeks
197449|NCT01576159|O2|Outcome|Moderate-Impact Loading|Performed Moderate-impact cycling exercise for 12 weeks
197450|NCT01576159|O1|Outcome|High-Impact Loading|Performed high-impact running exercise for 12 weeks
197451|NCT01576159|O4|Outcome|Control Group|Not participated any organized physical exercise
197452|NCT01576159|O3|Outcome|Non-Impact Loading|Performed non-impact swimming exercise during intervention period.
197453|NCT01576159|O2|Outcome|Moderate-Impact Loading|Performed Moderate-impact cycling exercise during intervention period.
197454|NCT01576159|O1|Outcome|High-Impact Loading|Performed high-impact running exercise during intervention period.
197455|NCT01576159|O4|Outcome|Control Group|Didn't participate any organized physical exercises
197456|NCT01576159|O3|Outcome|Non-Impact Loading|Performed low-impact swimming exercise during intervention period.
197457|NCT01576159|O2|Outcome|Moderate-Impact Loading|Performed moderate-impact cycling exercise during intervention period.
197458|NCT01576159|O1|Outcome|High-Impact Loading|Performed high-impact running exercise during intervention period.
197463|NCT01576146|B1|Baseline|Etelcalcetide|Participants received a bolus intravenous (IV) injection of etelcalcetide 3 times a week (TIW) at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
197464|NCT01576146|P1|Participant Flow|Etelcalcetide|Participants received a bolus intravenous (IV) injection of etelcalcetide 3 times a week (TIW) at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
197465|NCT01576146|O1|Outcome|Etelcalcetide|Participants received a bolus IV injection of etelcalcetide 3 times a week at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
197466|NCT01576146|O1|Outcome|Etelcalcetide|Participants received a bolus IV injection of etelcalcetide 3 times a week at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
197467|NCT01576146|O1|Outcome|Etelcalcetide|Participants received a bolus IV injection of etelcalcetide 3 times a week at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
197468|NCT01576146|O1|Outcome|Etelcalcetide|Participants received a bolus IV injection of etelcalcetide 3 times a week at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
197469|NCT01576146|E1|Reported Event|Etelcalcetide|Participants received a bolus IV injection of etelcalcetide 3 times a week at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
197470|NCT01576120|B3|Baseline|Total|Total of all reporting groups
197471|NCT01576120|B2|Baseline|Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)"
197472|NCT01576120|B1|Baseline|Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)"
197473|NCT01576120|P2|Participant Flow|Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)"
197474|NCT01576120|P1|Participant Flow|Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)"
197475|NCT01576120|O2|Outcome|Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)"
197476|NCT01576120|O1|Outcome|Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)"
197547|NCT01575808|B1|Baseline|GP1101|Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft
197579|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197477|NCT01576120|E2|Reported Event|Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)"
197478|NCT01576120|E1|Reported Event|Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)"
197479|NCT01576055|B3|Baseline|Total|Total of all reporting groups
197480|NCT01576055|B2|Baseline|BARD LifeStent|BARD LifeStent: Implant
197481|NCT01576055|B1|Baseline|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
197482|NCT01576055|P2|Participant Flow|BARD LifeStent|BARD LifeStent: Implant
197483|NCT01576055|P1|Participant Flow|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
197484|NCT01576055|O2|Outcome|BARD LifeStent|BARD LifeStent: Implant
197485|NCT01576055|O1|Outcome|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
197486|NCT01576055|O2|Outcome|BARD LifeStent|BARD LifeStent: Implant
197487|NCT01576055|O1|Outcome|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
197488|NCT01576055|O2|Outcome|BARD LifeStent|BARD LifeStent: Implant
197489|NCT01576055|O1|Outcome|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
197490|NCT01576055|O2|Outcome|BARD LifeStent|BARD LifeStent: Implant
197491|NCT01576055|O1|Outcome|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
197492|NCT01576055|E2|Reported Event|BARD LifeStent|BARD LifeStent: Implant
197493|NCT01576055|E1|Reported Event|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
197494|NCT01576042|B3|Baseline|Total|Total of all reporting groups
197495|NCT01576042|B2|Baseline|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
197496|NCT01576042|B1|Baseline|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
197497|NCT01576042|P2|Participant Flow|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
197498|NCT01576042|P1|Participant Flow|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
197499|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
197500|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
197501|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
197578|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
198416|NCT01571453|O2|Outcome|Venlafaxine|Venlafaxine extended release: 150 mg/day
197502|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
197503|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
197504|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
197505|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
197506|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
197507|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
197508|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
197509|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
197510|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
197511|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
197512|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
197513|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
197649|NCT01575756|O1|Outcome|Octafibrin/FIBRYGA®|Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
197514|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
197515|NCT01576042|E2|Reported Event|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
197516|NCT01576042|E1|Reported Event|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
197517|NCT01575912|B4|Baseline|Total|Total of all reporting groups
197518|NCT01575912|B3|Baseline|Group of Controls Without Psychiatric Disorder|subjects without any psychiatric disorder and submitted to experimental pain tests
197519|NCT01575912|B2|Baseline|Group of Subjects Presenting Major Depression MD|subjects presenting a major depression according to the DSM-IV-TR and submitted to experimental pain tests
197520|NCT01575912|B1|Baseline|Group of Subjects With Schizophrenia SC|subjects presenting a schizophrenia according to the DSM-IV-TR and submitted to experimental pain tests
197521|NCT01575912|P3|Participant Flow|Group of Subjects Without Psychiatric Troubles C|subjects without any psychiatric disorder and submitted to experimental pain tests
197522|NCT01575912|P2|Participant Flow|Group of Subjects Presenting Major Depression MD|subjects presenting a major depression according to the DSM-IV-TR and submitted to experimental pain tests
197523|NCT01575912|P1|Participant Flow|Group of Subjects Presenting Schizophrenia SC|subjects presenting a schizophrenia according to the DSM-IV-TR and submitted to experimental pain tests
197524|NCT01575912|O3|Outcome|Group of Subjects Without Psychiatric Troubles C|control subjects without any psychiatric disorder
197525|NCT01575912|O2|Outcome|Group of Subjects With Major Depression MD|subjects presenting a major depression according to the DSM-IV-TR and submitted to experimental pain tests
197526|NCT01575912|O1|Outcome|Group of Subjects Presenting Schizophrenia SC|subjects presenting a schizophrenia according to the DSM-IV-TR and submitted to experimental pain tests
197527|NCT01575912|E3|Reported Event|Group of Controls Without Psychiatric Disorder|control subjects without any psychiatric disorder and submitted to experimental pain tests
197528|NCT01575912|E2|Reported Event|Group of Subjects Presenting Major Depression MD|subjects presenting a diagnosis of major depression according to the DSM IV TR and submitted to experimental pain tests
197529|NCT01575912|E1|Reported Event|Group of Subjects With Schizophrenia SC|subjects presenting a diagnosis of schizophrenia according to the DSM IV TR and submitted to experimental pain tests
197530|NCT01575899|B4|Baseline|Total|Total of all reporting groups
197531|NCT01575899|B3|Baseline|Levofloxacin-Amox/Clav. (Re-eradication)|7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for re-eradication of patient still with evidence of Hp infection after previous intent of eradication.
197532|NCT01575899|B2|Baseline|Clarithromycin-Amoxicillin|7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
197533|NCT01575899|B1|Baseline|Levofloxacin-Amox/Clav.|7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
197534|NCT01575899|P3|Participant Flow|Levofloxacin-Amox/Clav. (Re-eradication)|7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for re-eradication of patient still with evidence of Hp infection after previous intent of eradication.
197535|NCT01575899|P2|Participant Flow|Clarithromycin-Amoxicillin|7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
197536|NCT01575899|P1|Participant Flow|Levofloxacin-Amox/Clav.|7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
197537|NCT01575899|O2|Outcome|Clarithromycin-Amoxicillin|Participants who are living in rural area and received 7-day clarithromycin, amoxicillin and rabeprazole for Hp eradication.
197538|NCT01575899|O1|Outcome|Levofloxacin-Amox/Clav.|Participants who are living in rural area and received 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for Hp eradication.
197539|NCT01575899|O1|Outcome|Levofloxacin-Amox/Clav. (Re-eradication)|7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for patients still with Hp infection previously treated with regimen without levofloxacin and Augmentin.
197540|NCT01575899|O2|Outcome|Clarithromycin-Amoxicillin|7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
197541|NCT01575899|O1|Outcome|Levofloxacin-Amox/Clav.|7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
197542|NCT01575899|E3|Reported Event|Levofloxacin-Amox/Clav. (Re-eradication)|7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for re-eradication of patient still with evidence of Hp infection after previous intent of eradication.
197543|NCT01575899|E2|Reported Event|Clarithromycin-Amoxicillin|7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
197544|NCT01575899|E1|Reported Event|Levofloxacin-Amox/Clav.|7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
197545|NCT01575808|B3|Baseline|Total|Total of all reporting groups
197546|NCT01575808|B2|Baseline|Retrospective Surgical Bypass Outcomes|Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
197548|NCT01575808|P2|Participant Flow|Retrospective Surgical Bypass Outcomes|Retrospective data collection (Apr 2012 - Apr 2014) surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
197549|NCT01575808|P1|Participant Flow|GP1101|"Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular Device Implantation"
197550|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197551|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197552|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197553|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197554|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197555|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197556|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197557|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197558|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197559|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197560|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197561|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197562|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197563|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197564|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197565|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197566|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197567|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197568|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197569|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197570|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197571|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197572|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197573|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197574|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197575|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197576|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197577|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
205169|NCT01545700|O5|Outcome|Placebo 0-4 Hours-4 Hours|
197580|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197581|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197582|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197583|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197584|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197585|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197586|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197587|NCT01575808|O1|Outcome|GP1101|"Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197588|NCT01575808|O1|Outcome|GP1101|Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft
197589|NCT01575808|O2|Outcome|Retrospective Surgical Bypass Outcomes|Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
197590|NCT01575808|O1|Outcome|GP1101|Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft
197591|NCT01575808|O2|Outcome|Retrospective Surgical Bypass Outcomes|Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
197592|NCT01575808|O1|Outcome|GP1101|Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft
197593|NCT01575808|O1|Outcome|GP1101|"Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft >~> GP1101: Endovascular stent graft implantation"
197594|NCT01575808|E1|Reported Event|GP1101|Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft
197595|NCT01575769|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
197596|NCT01575769|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilograms (mg/kg) via intravenous (IV) infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
197597|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
197598|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
197599|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
197600|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
197601|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
197602|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
197603|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
197604|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
197605|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
197606|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
197607|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
197608|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
197609|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
197610|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
197611|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
197612|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
197613|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
197614|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
197615|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
197616|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
197617|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available whichever, occurred first.
197618|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available whichever, occurred first.
197619|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
197620|NCT01575769|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available whichever, occurred first.
197621|NCT01575756|B1|Baseline|Full Analysis Set|All randomised participants who received at least 1 infusion of study medication (Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)) and for whom any post-treatment data were available.
197622|NCT01575756|P2|Participant Flow|Haemocomplettan® P/RiaSTAP(TM) Followed by Octafibrin/FIBRYGA®|Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once followed by Octafibrin/FIBRYGA® 70 mg/kg BW intravenously once 45 days later.
197623|NCT01575756|P1|Participant Flow|Octafibrin/FIBRYGA® Followed by Haemocomplettan® P/RiaSTAP(TM)|Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once followed by Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once 45 days later.
197624|NCT01575756|O2|Outcome|Haemocomplettan® P/RiaSTAP(TM)|Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
197625|NCT01575756|O1|Outcome|Octafibrin/FIBRYGA®|Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
197626|NCT01575756|O2|Outcome|Haemocomplettan® P/RiaSTAP(TM)|Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
197627|NCT01575756|O1|Outcome|Octafibrin/FIBRYGA®|Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
197628|NCT01575756|O2|Outcome|Haemocomplettan® P/RiaSTAP(TM)|Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
197629|NCT01575756|O1|Outcome|Octafibrin/FIBRYGA®|Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
197630|NCT01575756|O2|Outcome|Haemocomplettan® P/RiaSTAP(TM)|Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
197631|NCT01575756|O1|Outcome|Octafibrin/FIBRYGA®|Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
197632|NCT01575756|O2|Outcome|Haemocomplettan® P/RiaSTAP(TM)|Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
197633|NCT01575756|O1|Outcome|Octafibrin/FIBRYGA®|Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
197634|NCT01575756|O2|Outcome|Haemocomplettan® P/RiaSTAP(TM)|Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
197635|NCT01575756|O1|Outcome|Octafibrin/FIBRYGA®|Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
197636|NCT01575756|O2|Outcome|Haemocomplettan® P/RiaSTAP(TM)|Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
197637|NCT01575756|O1|Outcome|Octafibrin/FIBRYGA®|Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
197638|NCT01575756|O2|Outcome|Haemocomplettan® P/RiaSTAP(TM)|Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
197639|NCT01575756|O1|Outcome|Octafibrin/FIBRYGA®|Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
197640|NCT01575756|O2|Outcome|Haemocomplettan® P/RiaSTAP(TM)|Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
197641|NCT01575756|O1|Outcome|Octafibrin/FIBRYGA®|Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
197642|NCT01575756|O2|Outcome|Haemocomplettan® P/RiaSTAP(TM)|Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
197643|NCT01575756|O1|Outcome|Octafibrin/FIBRYGA®|Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
197644|NCT01575756|O2|Outcome|Haemocomplettan® P/RiaSTAP(TM)|Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
197645|NCT01575756|O1|Outcome|Octafibrin/FIBRYGA®|Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
197646|NCT01575756|O2|Outcome|Haemocomplettan® P/RiaSTAP(TM)|Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
197647|NCT01575756|O1|Outcome|Octafibrin/FIBRYGA®|Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
197648|NCT01575756|O2|Outcome|Haemocomplettan® P/RiaSTAP(TM)|Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
197650|NCT01575756|O1|Outcome|Pharmacokinetic (PK)-Per Protocol Dataset|Ratio comparison of participants who received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once, and participants who received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once
197651|NCT01575756|E2|Reported Event|Haemocomplettan® P/RiaSTAP(TM)|Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
197652|NCT01575756|E1|Reported Event|Octafibrin/FIBRYGA®|Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
197653|NCT01575561|B1|Baseline|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
197654|NCT01575561|P1|Participant Flow|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
197655|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
197656|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
197657|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
197658|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
197659|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
197660|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
197661|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
197662|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
197663|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
197664|NCT01575561|E1|Reported Event|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
197665|NCT01575522|B1|Baseline|Treatment (Tivantinib)|"Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
197666|NCT01575522|P1|Participant Flow|Treatment (Tivantinib)|"Patients receive tivantinib 360 mg PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
197667|NCT01575522|O1|Outcome|Evaluation of c-Met Positive Circulating Tumor Cells|
197668|NCT01575522|O1|Outcome|Evaluation of Phospho c-Met Positivity|MET amplification was defined as a MET/CEP7 ratio ≥ 2. Samples having a MET/CEP7 ratio from 1.5 and up to 2 were defined as having relative MET gain. Samples with a MET/CEP7 ratio of 1 but with more than two copies of each probe were defined as having polysomy of chromosome 7.
197669|NCT01575522|O1|Outcome|Evaluation of c-Met Positivity|MET amplification was defined as a MET/CEP7 ratio ≥ 2. Samples having a MET/CEP7 ratio from 1.5 and up to 2 were defined as having relative MET gain. Samples with a MET/CEP7 ratio of 1 but with more than two copies of each probe were defined as having polysomy of chromosome 7.
197670|NCT01575522|O1|Outcome|Treatment (Tivantinib)|"Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
197671|NCT01575522|O1|Outcome|Treatment (Tivantinib)|"Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
197672|NCT01575522|E1|Reported Event|Treatment (Tivantinib)|"Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
197673|NCT01575197|B4|Baseline|Total|Total of all reporting groups
197674|NCT01575197|B3|Baseline|Rotavirus Vaccine at Age 6,10,&14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6, 10, & 14 weeks of age.
197675|NCT01575197|B2|Baseline|Rotavirus Vaccine at Age 10 & 14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 10 & 14 weeks of age.
197676|NCT01575197|B1|Baseline|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
197677|NCT01575197|P3|Participant Flow|Rotavirus Vaccine at Age 6,10,&14 Weeks|Human rotavirus vaccine (HRV) was administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 6, 10, & 14 weeks of age.
197678|NCT01575197|P2|Participant Flow|Rotavirus Vaccine at Age 10 & 14 Weeks|Human rotavirus vaccine (HRV) was administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 10 & 14 weeks of age.
197679|NCT01575197|P1|Participant Flow|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine (HRV) was administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 6 & 10 weeks of age.
197680|NCT01575197|O2|Outcome|Rotavirus Vaccine at Age 10 & 14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 10 & 14 weeks of age.
198417|NCT01571453|O1|Outcome|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
197681|NCT01575197|O1|Outcome|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
197682|NCT01575197|O2|Outcome|Rotavirus Vaccine at Age 6,10,&14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6, 10, & 14 weeks of age.
197683|NCT01575197|O1|Outcome|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
197684|NCT01575197|O2|Outcome|Rotavirus Vaccine at Age 10 & 14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 10 & 14 weeks of age.
197685|NCT01575197|O1|Outcome|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
197686|NCT01575197|O2|Outcome|Rotavirus Vaccine at Age 6,10,&14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6, 10, & 14 weeks of age.
197687|NCT01575197|O1|Outcome|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
197688|NCT01575197|E3|Reported Event|Rotavirus Vaccine at Age 6,10,&14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6, 10, & 14 weeks of age.
197689|NCT01575197|E2|Reported Event|Rotavirus Vaccine at Age 10 & 14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 10 & 14 weeks of age.
197690|NCT01575197|E1|Reported Event|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
197691|NCT01575106|B1|Baseline|Heat Pain|"There is only one cohort in this study. All subjects receive the same intervention, the application of heat pain using TSA or CHEPS.~Heat pain applied using TSA or CHEPS: TSA-2001 Thermal Sensory Analyzer (Medoc LTD Advanced Medical Systems) or the Pathway Medoc (CHEPS model, Contact Heat-Evoked Potential Stimulator, Medoc LTD Advanced Medical Systems)"
197692|NCT01575106|P1|Participant Flow|Heat Pain|"There is only one cohort in this study. All subjects receive the same intervention, the application of heat pain using TSA or CHEPS.~Heat pain applied using TSA or CHEPS: TSA-2001 Thermal Sensory Analyzer (Medoc LTD Advanced Medical Systems) or the Pathway Medoc (CHEPS model, Contact Heat-Evoked Potential Stimulator, Medoc LTD Advanced Medical Systems)"
197693|NCT01575106|O1|Outcome|Heat Pain|"There is only one cohort in this study. All subjects receive the same intervention, the application of heat pain using TSA or CHEPS.~Heat pain applied using TSA or CHEPS: TSA-2001 Thermal Sensory Analyzer (Medoc LTD Advanced Medical Systems) or the Pathway Medoc (CHEPS model, Contact Heat-Evoked Potential Stimulator, Medoc LTD Advanced Medical Systems)"
197694|NCT01575106|O1|Outcome|Heat Pain|"There is only one cohort in this study. All subjects receive the same intervention, the application of heat pain using TSA or CHEPS.~Heat pain applied using TSA or CHEPS: TSA-2001 Thermal Sensory Analyzer (Medoc LTD Advanced Medical Systems) or the Pathway Medoc (CHEPS model, Contact Heat-Evoked Potential Stimulator, Medoc LTD Advanced Medical Systems)"
197695|NCT01575106|E2|Reported Event|Cream|All subjects were told they would receive lidocaine, capsaicin, and neutral cream on their forearm, but in reality they only received neutral cream (regular moisturizing lotion).
197696|NCT01575106|E1|Reported Event|Heat Pain|"All subjects receive the same intervention, the application of heat pain using TSA or CHEPS.~Heat pain applied using TSA or CHEPS: TSA-2001 Thermal Sensory Analyzer (Medoc LTD Advanced Medical Systems) or the Pathway Medoc (CHEPS model, Contact Heat-Evoked Potential Stimulator, Medoc LTD Advanced Medical Systems)"
197697|NCT01575080|B1|Baseline|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
197698|NCT01575080|P1|Participant Flow|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
197699|NCT01575080|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
197700|NCT01575080|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
197701|NCT01575080|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
197702|NCT01575080|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
197703|NCT01575080|E1|Reported Event|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
197704|NCT01575054|B3|Baseline|Total|Total of all reporting groups
197705|NCT01575054|B2|Baseline|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
197706|NCT01575054|B1|Baseline|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
197707|NCT01575054|P2|Participant Flow|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
197708|NCT01575054|P1|Participant Flow|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
197709|NCT01575054|O2|Outcome|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
197710|NCT01575054|O1|Outcome|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
197711|NCT01575054|O2|Outcome|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
197712|NCT01575054|O1|Outcome|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
197713|NCT01575054|O2|Outcome|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
197714|NCT01575054|O1|Outcome|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
197715|NCT01575054|O2|Outcome|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
197716|NCT01575054|O1|Outcome|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
197717|NCT01575054|O2|Outcome|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
197718|NCT01575054|O1|Outcome|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
197719|NCT01575054|E2|Reported Event|Normal Saline (Placebo)|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles.
197720|NCT01575054|E1|Reported Event|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles.
197721|NCT01575028|B3|Baseline|Total|Total of all reporting groups
197722|NCT01575028|B2|Baseline|Transversus Abdominis Plane (TAP) Block|"Patients will receive a transversus abdominis plane (TAP) block.~Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally"
197723|NCT01575028|B1|Baseline|Local Anesthetic Infiltration Injection|"Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.~Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon."
197724|NCT01575028|P2|Participant Flow|Transversus Abdominis Plane (TAP) Block|"Patients will receive a transversus abdominis plane (TAP) block.~Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally"
197725|NCT01575028|P1|Participant Flow|Local Anesthetic Infiltration Injection|"Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.~Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon."
197726|NCT01575028|O2|Outcome|Transversus Abdominis Plane (TAP) Block|"Patients will receive a transversus abdominis plane (TAP) block.~Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally"
197727|NCT01575028|O1|Outcome|Local Anesthetic Infiltration Injection|"Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.~Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon."
197818|NCT01574326|O1|Outcome|FDP-Placebo for Sevelamer Carbonate|Participants received placebo for sevelamer carbonate for first 2 weeks in FDP.
197728|NCT01575028|E2|Reported Event|Transversus Abdominis Plane (TAP) Block|"Patients will receive a transversus abdominis plane (TAP) block.~Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally"
197729|NCT01575028|E1|Reported Event|Local Anesthetic Infiltration Injection|"Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.~Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon."
197730|NCT01574703|B5|Baseline|Total|Total of all reporting groups
197731|NCT01574703|B4|Baseline|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
197732|NCT01574703|B3|Baseline|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
197733|NCT01574703|B2|Baseline|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
197734|NCT01574703|B1|Baseline|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
197735|NCT01574703|P4|Participant Flow|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
197736|NCT01574703|P3|Participant Flow|Nicotine Replacement Therapy (NRT) Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
197737|NCT01574703|P2|Participant Flow|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
197738|NCT01574703|P1|Participant Flow|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
197739|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
197740|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
197741|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
197742|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
197743|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
197744|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
197745|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
197746|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
197747|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
197748|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
197749|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
198418|NCT01571453|O2|Outcome|Venlafaxine|Venlafaxine extended release: 150 mg/day
198419|NCT01571453|O1|Outcome|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
197750|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
197751|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
197752|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
197753|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
197754|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
197755|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
197756|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
197757|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
197758|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
197759|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
197760|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
197761|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
197762|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
197763|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
197764|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
197765|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
197766|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
197767|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
197768|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
197769|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
197770|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
197817|NCT01574326|O2|Outcome|FDP–Sevelamer Carbonate|Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for 2 weeks in FDP.
197771|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
197772|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
197773|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
197774|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
197775|NCT01574703|E4|Reported Event|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
197776|NCT01574703|E3|Reported Event|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
197777|NCT01574703|E2|Reported Event|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
197778|NCT01574703|E1|Reported Event|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
197779|NCT01574651|B3|Baseline|Total|Total of all reporting groups
197780|NCT01574651|B2|Baseline|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
197781|NCT01574651|B1|Baseline|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
197782|NCT01574651|P2|Participant Flow|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
197783|NCT01574651|P1|Participant Flow|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
197784|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
197785|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
197786|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
197787|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
197788|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
197789|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
197790|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
197791|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
197792|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
197793|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
197794|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
197795|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
197796|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
197797|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
197798|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
197799|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
197800|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
197801|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
197802|NCT01574651|E2|Reported Event|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
197803|NCT01574651|E1|Reported Event|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
197804|NCT01574612|B1|Baseline|Topical Cream|xerese topical cream is the only active used in this trial
197805|NCT01574612|P1|Participant Flow|Topical Cream|"commercial product being used~acyclovir/hydrocortisone cream: cream applied topically to lesion five times daily for five days"
197806|NCT01574612|O1|Outcome|Topical Cream|commercial cream used
197807|NCT01574612|E1|Reported Event|Topical Cream|"commercial product being used~acyclovir/hydrocortisone cream: cream applied topically to lesion five times daily for five days"
197808|NCT01574326|B3|Baseline|Total|Total of all reporting groups
197809|NCT01574326|B2|Baseline|FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate|Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on screening BSA category) for 2 weeks in FDP and then continued to receive sevelamer carbonate in DTP. Sevelamer carbonate for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 as POS or 1.6 g TID for BSA ≥1.2 m^2 either as POS or tablets as per participant’s preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as dose prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator’s opinion. Dose titrations were based on BSA category: by 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to <1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meal/snacks).
197810|NCT01574326|B1|Baseline|FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate|Participants received placebo for sevelamer carbonate for 2 weeks in FDP and sevelamer carbonate for 26 weeks in DTP. Placebo matched to sevelamer carbonate TID for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 POS and 1.6 g TID for BSA ≥1.2 m^2 as POS/tablets as per participant's preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator's opinion. Dose titrations were based on BSA category: 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to < 1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meals/snacks).
197811|NCT01574326|P2|Participant Flow|FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate|Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on screening BSA category) for 2 weeks in FDP and then continued to receive sevelamer carbonate in DTP. Sevelamer carbonate for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 as POS or 1.6 g TID for BSA ≥1.2 m^2 either as POS or tablets as per participant’s preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as dose prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator’s opinion. Dose titrations were based on BSA category: by 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to <1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meal/snacks).
197812|NCT01574326|P1|Participant Flow|FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate|Participants received placebo for sevelamer carbonate for 2 weeks in FDP and sevelamer carbonate for 26 weeks in DTP. Placebo matched to sevelamer carbonate 3 times a day (TID) for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 as powder for oral suspension (POS) & 1.6 g TID for BSA ≥1.2 m^2 as POS/tablets as per participant’s preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator’s opinion. Dose titrations were based on BSA category: 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to < 1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meals/snacks).
197813|NCT01574326|O2|Outcome|FDP-Sevelamer Carbonate, DTP–Sevelamer Carbonate|Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for 2 weeks in FDP. Thereafter, participants continued to receive sevelamer carbonate for 26 weeks in DTP.
197814|NCT01574326|O1|Outcome|FDP- Placebo for Sevelamer Carbonate; DTP– Sevelamer Carbonate|Participants received placebo for sevelamer carbonate for first 2 weeks in FDP. Thereafter participants received sevelamer carbonate for 26 weeks in DTP.
197815|NCT01574326|O2|Outcome|FDP-Sevelamer Carbonate, DTP–Sevelamer Carbonate|Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for 2 weeks in FDP. Thereafter, participants continued to receive sevelamer carbonate for 26 weeks in DTP based on the screening BSA category.
197816|NCT01574326|O1|Outcome|FDP- Placebo for Sevelamer Carbonate; DTP– Sevelamer Carbonate|Participants received placebo for sevelamer carbonate for first 2 weeks in FDP. Thereafter, participants received sevelamer carbonate for 26 weeks in DTP.
197819|NCT01574326|E3|Reported Event|DTP - Sevelamer Carbonate|Participants who received placebo and participants who received sevelamer carbonate in FDP received sevelamer carbonate for 26 weeks in DTP (median exposure of 183.5 days in participants who were on sevelamer carbonate in FDP and 183 days in participants who were on placebo in FDP).
197820|NCT01574326|E2|Reported Event|FDP - Sevelamer Carbonate|Participants exposed to sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for first 2 weeks in FDP (median exposure of 15 days).
197821|NCT01574326|E1|Reported Event|FDP - Placebo|Participants exposed to placebo (for sevelamer carbonate) for first 2 weeks in FDP (median exposure of 15 days).
197822|NCT01574248|B3|Baseline|Total|Total of all reporting groups
197823|NCT01574248|B2|Baseline|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
197824|NCT01574248|B1|Baseline|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
197825|NCT01574248|P2|Participant Flow|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
197826|NCT01574248|P1|Participant Flow|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
197827|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
197828|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
197829|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
197830|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
197831|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
197832|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
197833|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
197834|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
197835|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
197836|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
197837|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
197838|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
197839|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
197840|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
197841|NCT01574248|E2|Reported Event|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
197842|NCT01574248|E1|Reported Event|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
197843|NCT01574183|B3|Baseline|Total|Total of all reporting groups
197844|NCT01574183|B2|Baseline|Placebo|"Flexible dose up to 40 mg capsule daily~Placebo: 40 mg capsule daily"
197845|NCT01574183|B1|Baseline|Vilazodone|"Flexible dose up to 40 mg capsule daily~Vilazodone: 40 mg capsule daily"
197846|NCT01574183|P2|Participant Flow|Placebo|"Flexible dose up to 40 mg capsule daily~Placebo: 40 mg capsule daily"
197847|NCT01574183|P1|Participant Flow|Vilazodone|"Flexible dose up to 40 mg capsule daily~Vilazodone: 40 mg capsule daily"
197848|NCT01574183|O2|Outcome|Placebo|"Flexible dose up to 40 mg capsule daily~Placebo: 40 mg capsule daily"
197849|NCT01574183|O1|Outcome|Vilazodone|"Flexible dose up to 40 mg capsule daily~Vilazodone: 40 mg capsule daily"
197850|NCT01574183|O2|Outcome|Placebo|"Flexible dose up to 40 mg capsule daily~Placebo: 40 mg capsule daily"
197851|NCT01574183|O1|Outcome|Vilazodone|"Flexible dose up to 40 mg capsule daily~Vilazodone: 40 mg capsule daily"
197852|NCT01574183|O2|Outcome|Placebo|"Flexible dose up to 40 mg capsule daily~Placebo: up to 40 mg capsule daily"
197853|NCT01574183|O1|Outcome|Vilazodone|"Flexible dose up to 40 mg capsule daily~Vilazodone: up to 40 mg capsule daily"
197854|NCT01574183|E2|Reported Event|Placebo|Flexible dose Placebo: up to 40 mg capsule daily
197855|NCT01574183|E1|Reported Event|Vilazodone|Flexible dose Vilazodone: up to 40 mg capsule daily
197856|NCT01574105|B3|Baseline|Total|Total of all reporting groups
197857|NCT01574105|B2|Baseline|Heparin Sensitive|Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
197858|NCT01574105|B1|Baseline|Heparin Resistant|Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.
197859|NCT01574105|P2|Participant Flow|Heparin Sensitive|Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
197860|NCT01574105|P1|Participant Flow|Heparin Resistant|Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.
197861|NCT01574105|O2|Outcome|Heparin Sensitive|Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
197862|NCT01574105|O1|Outcome|Heparin Resistant|Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.
197863|NCT01574105|O2|Outcome|Heparin Sensitive|Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
197864|NCT01574105|O1|Outcome|Heparin Resistant|Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.
197865|NCT01574105|E2|Reported Event|Heparin Sensitive|Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
197866|NCT01574105|E1|Reported Event|Heparin Resistant|Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.
197867|NCT01574079|B3|Baseline|Total|Total of all reporting groups
197868|NCT01574079|B2|Baseline|Physical Therapy Plus Mirror Therapy|The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
197869|NCT01574079|B1|Baseline|Traditional Physical Therapy|The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
197870|NCT01574079|P2|Participant Flow|Physical Therapy Plus Mirror Therapy|The treatment group will receive traditional physical therapy with the addition of 15 minutes of mirror therapy consisting of lower extremity ankle dorsiflexion, knee flexion, and hip flexion. The participant will attempt to perform the exercises with both lower extremities. The patient will be blinded to the affected lower extremity with a mirror, and will be looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performs the activities.
197871|NCT01574079|P1|Participant Flow|Traditional Physical Therapy|The control group will receive traditional physical therapy which includes, but is not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
197872|NCT01574079|O2|Outcome|Treatment Group|The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
197873|NCT01574079|O1|Outcome|Control Group|The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
197874|NCT01574079|O2|Outcome|Treatment Group|The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
197875|NCT01574079|O1|Outcome|Control Group|The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
197876|NCT01574079|O2|Outcome|Treatment Group|The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
197877|NCT01574079|O1|Outcome|Control Group|The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
197878|NCT01574079|E2|Reported Event|Treatment Group|The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
197879|NCT01574079|E1|Reported Event|Control Group|The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
197880|NCT01573910|B3|Baseline|Total|Total of all reporting groups
197881|NCT01573910|B2|Baseline|Ofloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
197882|NCT01573910|B1|Baseline|Moxifloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
197883|NCT01573910|P2|Participant Flow|Ofloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
197884|NCT01573910|P1|Participant Flow|Moxifloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
197885|NCT01573910|O2|Outcome|Ofloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
197886|NCT01573910|O1|Outcome|Moxifloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
197887|NCT01573910|O2|Outcome|Ofloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
197888|NCT01573910|O1|Outcome|Moxifloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
197889|NCT01573910|E2|Reported Event|Ofloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
197890|NCT01573910|E1|Reported Event|Moxifloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
197891|NCT01573767|B5|Baseline|Total|Total of all reporting groups
197892|NCT01573767|B4|Baseline|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197893|NCT01573767|B3|Baseline|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197894|NCT01573767|B2|Baseline|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197895|NCT01573767|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197896|NCT01573767|P4|Participant Flow|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197897|NCT01573767|P3|Participant Flow|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197898|NCT01573767|P2|Participant Flow|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197899|NCT01573767|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197900|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197901|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197902|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197903|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197904|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197905|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197906|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197907|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197908|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197909|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197910|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197911|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197912|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197913|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197914|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197915|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197916|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197917|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197918|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
198020|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
197919|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197920|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197921|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197922|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197923|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197924|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197925|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197926|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197927|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197928|NCT01573767|E4|Reported Event|VI 25 OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197929|NCT01573767|E3|Reported Event|VI 12.5 OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197930|NCT01573767|E2|Reported Event|VI 6.25 OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197931|NCT01573767|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
197932|NCT01573624|B1|Baseline|All Treatments Combined|The participants received 3 of the 7 possible treatments during the 3 double blind treatment periods. Participants received study treatments in a crossover manner according to their randomization sequence. The 7 treatment regimens were, FF 100 mcg, FF 100 mcg + UMEC 15.6 mcg, FF 100 mcg + UMEC 31.25 mcg, FF 100 mcg + UMEC 62.5 mcg, FF 100 mcg + UMEC 125 mcg, FF 100 mcg + UMEC 250 mcg and FF 100 mcg + VI 25 mcg. The study treatments were administered via a DPI taken once daily in the morning for 14 days during each study period. The treatment periods were separated by 2 washout periods of 12-14 days each. During the two week run-in period and during the two washout period, participants were administered open-label FF 100 mcg once daily in the morning via a DPI. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197933|NCT01573624|P7|Participant Flow|FF 100 mcg + VI 25 mcg First|Participants received fixed dose of FF 100 mcg and vilanterol (VI) 25 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197934|NCT01573624|P6|Participant Flow|FF 100 mcg + UMEC 250 mcg First|Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197935|NCT01573624|P5|Participant Flow|FF 100 mcg + UMEC 125 mcg First|Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197936|NCT01573624|P4|Participant Flow|FF 100 mcg + UMEC 62.5 mcg First|Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
198139|NCT01572948|E2|Reported Event|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
197937|NCT01573624|P3|Participant Flow|FF 100 mcg + UMEC 31.25 mcg First|Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197938|NCT01573624|P2|Participant Flow|FF 100 mcg + UMEC 15.6 mcg First|Participants received fixed dose of FF 100 mcg and umeclidinium bromide (UMEC) 15.6 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197939|NCT01573624|P1|Participant Flow|FF 100 mcg First|Participants received a dose of FF 100 mcg via a dry powder inhaler (DPI) once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol metered-dose inhaler (MDI) was provided as the rescue medication.
197940|NCT01573624|O7|Outcome|FF 100 mcg + VI 25 mcg|Participants received fixed dose of FF 100 mcg and VI 25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197941|NCT01573624|O6|Outcome|FF 100 mcg + UMEC 250 mcg|Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197942|NCT01573624|O5|Outcome|FF 100 mcg + UMEC 125 mcg|Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197943|NCT01573624|O4|Outcome|FF 100 mcg + UMEC 62.5 mcg|Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197944|NCT01573624|O3|Outcome|FF 100 mcg + UMEC 31.25 mcg|Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197945|NCT01573624|O2|Outcome|FF 100 mcg + UMEC 15.6 mcg|Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197946|NCT01573624|O1|Outcome|FF 100 mcg|Participants received a dose of FF 100 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197947|NCT01573624|O7|Outcome|FF 100 mcg + VI 25 mcg|Participants received fixed dose of FF 100 mcg and VI 25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197948|NCT01573624|O6|Outcome|FF 100 mcg + UMEC 250 mcg|Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197949|NCT01573624|O5|Outcome|FF 100 mcg + UMEC 125 mcg|Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
198140|NCT01572948|E1|Reported Event|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
197950|NCT01573624|O4|Outcome|FF 100 mcg + UMEC 62.5 mcg|Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197951|NCT01573624|O3|Outcome|FF 100 mcg + UMEC 31.25 mcg|Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197952|NCT01573624|O2|Outcome|FF 100 mcg + UMEC 15.6 mcg|Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197953|NCT01573624|O1|Outcome|FF 100 mcg|Participants received a dose of FF 100 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197954|NCT01573624|O7|Outcome|FF 100 mcg + VI 25 mcg|Participants received fixed dose of FF 100 mcg and VI 25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197955|NCT01573624|O6|Outcome|FF 100 mcg + UMEC 250 mcg|Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197956|NCT01573624|O5|Outcome|FF 100 mcg + UMEC 125 mcg|Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197957|NCT01573624|O4|Outcome|FF 100 mcg + UMEC 62.5 mcg|Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197958|NCT01573624|O3|Outcome|FF 100 mcg + UMEC 31.25 mcg|Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197959|NCT01573624|O2|Outcome|FF 100 mcg + UMEC 15.6 mcg|Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197960|NCT01573624|O1|Outcome|FF 100 mcg|Participants received a dose of FF 100 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197961|NCT01573624|O7|Outcome|FF 100 mcg + VI 25 mcg|Participants received fixed dose of FF 100 mcg and VI 25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197962|NCT01573624|O6|Outcome|FF 100 mcg + UMEC 250 mcg|Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197997|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
197963|NCT01573624|O5|Outcome|FF 100 mcg + UMEC 125 mcg|Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197964|NCT01573624|O4|Outcome|FF 100 mcg + UMEC 62.5 mcg|Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197965|NCT01573624|O3|Outcome|FF 100 mcg + UMEC 31.25 mcg|Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197966|NCT01573624|O2|Outcome|FF 100mcg + UMEC 15.6 mcg|Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197967|NCT01573624|O1|Outcome|FF 100 mcg|Participants received a dose of FF 100 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197968|NCT01573624|O5|Outcome|FF 100 mcg + UMEC 250 mcg|Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197969|NCT01573624|O4|Outcome|FF 100 mcg + UMEC 125 mcg|Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197970|NCT01573624|O3|Outcome|FF 100 mcg + UMEC 62.5 mcg|Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197971|NCT01573624|O2|Outcome|FF 100 mcg + UMEC 31.25 mcg|Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197972|NCT01573624|O1|Outcome|FF 100 mcg + UMEC 15.6 mcg|Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197973|NCT01573624|O5|Outcome|FF 100 mcg + UMEC 250 mcg|Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197974|NCT01573624|O4|Outcome|FF 100 mcg + UMEC 125 mcg|Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197975|NCT01573624|O3|Outcome|FF 100 mcg + UMEC 62.5 mcg|Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197998|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
198141|NCT01572844|B1|Baseline|All Study Participants|This Arm includes all participants who were enrolled in the study
197976|NCT01573624|O2|Outcome|FF 100 mcg + UMEC 31.25 mcg|Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197977|NCT01573624|O1|Outcome|FF 100 mcg + UMEC 15.6 mcg|Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197978|NCT01573624|E7|Reported Event|FF 100 mcg + VI 25 mcg|Participants received fixed dose of FF 100 mcg and VI 25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197979|NCT01573624|E6|Reported Event|FF 100 mcg + UMEC 250 mcg|Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197980|NCT01573624|E5|Reported Event|FF 100 mcg + UMEC 125 mcg|Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197981|NCT01573624|E4|Reported Event|FF 100 mcg + UMEC 62.5 mcg|Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197982|NCT01573624|E3|Reported Event|FF 100 mcg + UMEC 31.25 mcg|Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197983|NCT01573624|E2|Reported Event|FF 100 mcg + UMEC 15.6 mcg|Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197984|NCT01573624|E1|Reported Event|FF 100 mcg|Participants received a dose of FF 100 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
197985|NCT01573325|B1|Baseline|Study Popoulation|There was only one group as this was a descriptive prospective study
197986|NCT01573325|P1|Participant Flow|Study Popoulation|There was only one group as this was a descriptive prospective study. They all completed identical questionnaires including the Quality of Life Index, the Short-form Liver Disease Quality of Life tool, the Medical Outcomes Study Social Support Survey, the demographic tool and the Center for Epidemiological Studies Depression tool.
197987|NCT01573325|O1|Outcome|Population Predicted by Have Poor HRQOL by Depressive Symptoms|
197988|NCT01573325|O1|Outcome|Study Popoulation|There was only one group as this was a descriptive prospective study
197989|NCT01573325|E1|Reported Event|Study Popoulation|There was only one group as this was a descriptive prospective study
197990|NCT01573260|B3|Baseline|Total|Total of all reporting groups
197991|NCT01573260|B2|Baseline|Tango|
197992|NCT01573260|B1|Baseline|Control|
197993|NCT01573260|P2|Participant Flow|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
197994|NCT01573260|P1|Participant Flow|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
197995|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
197996|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
205170|NCT01545700|O4|Outcome|Placebo 0-4 Hours-3 Hours|
197999|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
198000|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
198001|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
198002|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
198003|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
198004|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
198005|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
198006|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
198007|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
198008|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
198009|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
198010|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
198011|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
198012|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
198013|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
198014|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
198015|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
198016|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
198017|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Intervention: Patient will receive information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
198018|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly class of argentinean tango for a period of 3-months the intervention for this arm~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
198019|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
198142|NCT01572844|P2|Participant Flow|No Treatment Lesion|Lesion B, similar area of calcinosis on the same patient, which did not receive treatment, is evaluated.
198021|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
198022|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
198023|NCT01573260|E2|Reported Event|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
198024|NCT01573260|E1|Reported Event|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
198025|NCT01573000|B3|Baseline|Total|Total of all reporting groups
198026|NCT01573000|B2|Baseline|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198027|NCT01573000|B1|Baseline|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198028|NCT01573000|P2|Participant Flow|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198029|NCT01573000|P1|Participant Flow|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198030|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198031|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198032|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198033|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198183|NCT01572792|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
198184|NCT01572792|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
198034|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198035|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198036|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198037|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198038|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198039|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198040|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198041|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198042|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198043|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198044|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198057|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198045|NCT01573000|O2|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198046|NCT01573000|O1|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198047|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198048|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198049|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198050|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198051|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198052|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198053|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198054|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198055|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198056|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198058|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198059|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198060|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198061|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198062|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198063|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198064|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198065|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198066|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198067|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198068|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198185|NCT01572792|O1|Outcome|Placebo|Placebo administered BID by inhalation
198186|NCT01572792|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
198187|NCT01572792|O4|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
207390|NCT01536574|B3|Baseline|Total|Total of all reporting groups
198069|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198070|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198071|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198072|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198073|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198074|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198075|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198076|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198077|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198078|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198079|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198116|NCT01573000|O1|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198080|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198081|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198082|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198083|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198084|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198085|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198086|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198087|NCT01573000|O2|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198088|NCT01573000|O1|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198089|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198090|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198091|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198188|NCT01572792|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
198092|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198093|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198094|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198095|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198096|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198097|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198098|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198099|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198100|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198101|NCT01573000|O2|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198102|NCT01573000|O1|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198103|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198420|NCT01571453|O2|Outcome|Venlafaxine|Venlafaxine extended release: 150 mg/day
198104|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198105|NCT01573000|O2|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198106|NCT01573000|O1|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198107|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198108|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198109|NCT01573000|O2|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198110|NCT01573000|O1|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198111|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198112|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198113|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198114|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198115|NCT01573000|O2|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198117|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198118|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198119|NCT01573000|E3|Reported Event|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198120|NCT01573000|E2|Reported Event|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198121|NCT01573000|E1|Reported Event|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
198122|NCT01572948|B3|Baseline|Total|Total of all reporting groups
198123|NCT01572948|B2|Baseline|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
198124|NCT01572948|B1|Baseline|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
198125|NCT01572948|P2|Participant Flow|Placebo|500microgram white tablet
198126|NCT01572948|P1|Participant Flow|Roflumilast|group randomized to 30 day supply of white tablet 500microgram
198127|NCT01572948|O2|Outcome|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
198128|NCT01572948|O1|Outcome|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
198129|NCT01572948|O2|Outcome|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
198130|NCT01572948|O1|Outcome|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
198131|NCT01572948|O2|Outcome|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
198132|NCT01572948|O1|Outcome|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
198133|NCT01572948|O2|Outcome|Placebo|500microgram white tablet
198134|NCT01572948|O1|Outcome|Roflumilast|group randomized to 30 day supply of white tablet 500microgram
198135|NCT01572948|O2|Outcome|Daliresp|"The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models~roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models"
198136|NCT01572948|O1|Outcome|Placebo|"The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient.~placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient"
198137|NCT01572948|O2|Outcome|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
198138|NCT01572948|O1|Outcome|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
198189|NCT01572792|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
198143|NCT01572844|P1|Participant Flow|Treatment Lesion|"Lesion A, target lesion Fractionated Carbon Dioxide (FCO2) Laser: At each treatment visit, the target area (2cm x 2cm) (+/- 1cm) of the calcinosis lesions will be treated with one pass of the Candela QuadraLase (TM) FCO2 laser.~Sodium thiosulfate: Following treatment with FCO2 laser, 4 ml of 5% Sodium Thiosulfate solution will be applied to the treatment site only.~Subjects will receive a total of 8-10 treatments over a 6 month period."
198144|NCT01572844|O1|Outcome|Treatment Lesion|"Lesion A, target lesion Fractionated Carbon Dioxide (FCO2) Laser: At each treatment visit, the target area (2cm x 2cm) (+/- 1cm) of the calcinosis lesions will be treated with one pass of the Candela QuadraLase (TM) FCO2 laser.~Sodium thiosulfate: Following treatment with FCO2 laser, 4 ml of 5% Sodium Thiosulfate solution will be applied to the treatment site only.~Subjects will receive a total of 8-10 treatments over a 6 month period."
198145|NCT01572844|O2|Outcome|No Treatment Lesion|Lesion B, similar area of calcinosis on the same patient, which did not receive treatment
198146|NCT01572844|O1|Outcome|Treatment Lesion|Lesion A, target lesion
198147|NCT01572844|O2|Outcome|No Treatment Lesion|Lesion B, similar area of calcinosis on the same patient, which did not receive treatment, is evaluated.
198148|NCT01572844|O1|Outcome|Treatment Lesion|"Lesion A, target lesion Fractionated Carbon Dioxide (FCO2) Laser: At each treatment visit, the target area (2cm x 2cm) (+/- 1cm) of the calcinosis lesions will be treated with one pass of the Candela QuadraLase (TM) FCO2 laser.~Sodium thiosulfate: Following treatment with FCO2 laser, 4 ml of 5% Sodium Thiosulfate solution will be applied to the treatment site only.~Subjects will receive a total of 8-10 treatments over a 6 month period."
198149|NCT01572844|O2|Outcome|No Treatment Lesion|Lesion B, similar area of calcinosis on the same patient, which did not receive treatment, is evaluated.
198150|NCT01572844|O1|Outcome|Treatment Lesion|Lesion A, target lesion Fractionated Carbon Dioxide (FCO2) Laser
198151|NCT01572844|O2|Outcome|No Treatment Lesion|Lesion B, similar area of calcinosis on the same patient, which did not receive treatment, is evaluated.
198152|NCT01572844|O1|Outcome|Treatment Lesion|"Lesion A, target lesion Fractionated Carbon Dioxide (FCO2) Laser: At each treatment visit, the target area (2cm x 2cm) (+/- 1cm) of the calcinosis lesions will be treated with one pass of the Candela QuadraLase (TM) FCO2 laser.~Sodium thiosulfate: Following treatment with FCO2 laser, 4 ml of 5% Sodium Thiosulfate solution will be applied to the treatment site only.~Subjects will receive a total of 8-10 treatments over a 6 month period."
198153|NCT01572844|E2|Reported Event|No Treatment Lesion|Lesion B, similar area of calcinosis on the same patient, which did not receive treatment, is evaluated.
198154|NCT01572844|E1|Reported Event|Treatment Lesion|"Lesion A, target lesion Fractionated Carbon Dioxide (FCO2) Laser: At each treatment visit, the target area (2cm x 2cm) (+/- 1cm) of the calcinosis lesions will be treated with one pass of the Candela QuadraLase (TM) FCO2 laser.~Sodium thiosulfate: Following treatment with FCO2 laser, 4 ml of 5% Sodium Thiosulfate solution will be applied to the treatment site only.~Subjects will receive a total of 8-10 treatments over a 6 month period."
198155|NCT01572792|B6|Baseline|Total|Total of all reporting groups
198156|NCT01572792|B5|Baseline|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
198157|NCT01572792|B4|Baseline|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
198158|NCT01572792|B3|Baseline|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
198159|NCT01572792|B2|Baseline|Aclidinium/Formoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
198160|NCT01572792|B1|Baseline|Placebo|Placebo administered BID by inhalation
198161|NCT01572792|P5|Participant Flow|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
198162|NCT01572792|P4|Participant Flow|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
198163|NCT01572792|P3|Participant Flow|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
198164|NCT01572792|P2|Participant Flow|Aclidinium/Formoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
198165|NCT01572792|P1|Participant Flow|Placebo|Placebo administered BID by inhalation
198166|NCT01572792|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
198167|NCT01572792|O4|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
198168|NCT01572792|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
198169|NCT01572792|O2|Outcome|Aclidinium/Formmoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
198170|NCT01572792|O1|Outcome|Placebo|Placebo administered BID by inhalation
198171|NCT01572792|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
198172|NCT01572792|O4|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
198173|NCT01572792|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
198174|NCT01572792|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
198175|NCT01572792|O1|Outcome|Placebo|Placebo administered BID by inhalation
198176|NCT01572792|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
198177|NCT01572792|O4|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
198178|NCT01572792|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
198179|NCT01572792|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
198180|NCT01572792|O1|Outcome|Placebo|Placebo administered BID by inhalation
198181|NCT01572792|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
198182|NCT01572792|O4|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
198193|NCT01572792|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
198194|NCT01572792|O2|Outcome|Aclidinium/Formmoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
198195|NCT01572792|O1|Outcome|Placebo|Placebo administered BID by inhalation
198196|NCT01572792|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
198197|NCT01572792|O4|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
198198|NCT01572792|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
198199|NCT01572792|O2|Outcome|Aclidinium/Formmoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
198200|NCT01572792|O1|Outcome|Placebo|Placebo administered BID by inhalation
198201|NCT01572792|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
198202|NCT01572792|O4|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
198203|NCT01572792|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
198204|NCT01572792|O2|Outcome|Aclidinium/Formmoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
198205|NCT01572792|O1|Outcome|Placebo|Placebo administered BID by inhalation
198206|NCT01572792|E5|Reported Event|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
198207|NCT01572792|E4|Reported Event|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
198208|NCT01572792|E3|Reported Event|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
198209|NCT01572792|E2|Reported Event|Aclidinium/Formoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
198210|NCT01572792|E1|Reported Event|Placebo|Placebo administered BID by inhalation
198211|NCT01572740|B3|Baseline|Total|Total of all reporting groups
198212|NCT01572740|B2|Baseline|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198213|NCT01572740|B1|Baseline|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198214|NCT01572740|P2|Participant Flow|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198215|NCT01572740|P1|Participant Flow|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198216|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198217|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198270|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198271|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198218|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198219|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198220|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198221|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198222|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198223|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198224|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198225|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198226|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198227|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198228|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198229|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198230|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198231|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198232|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198233|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198234|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198235|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198236|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198237|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198238|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198239|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198240|NCT01572740|E2|Reported Event|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198241|NCT01572740|E1|Reported Event|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
198242|NCT01572727|B3|Baseline|Total|Total of all reporting groups
198243|NCT01572727|B2|Baseline|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
198244|NCT01572727|B1|Baseline|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
198245|NCT01572727|P2|Participant Flow|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
198246|NCT01572727|P1|Participant Flow|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
198247|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
198248|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
198249|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
198250|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
198251|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
198252|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
198253|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
198254|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
198255|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
198256|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
198257|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
198258|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
198259|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
198260|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
198261|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
198262|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
198263|NCT01572727|E2|Reported Event|Placebo 100 mg Plus Paclitaxel 80 mg Per m2|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
198264|NCT01572727|E1|Reported Event|Buparlisib (BKM120) 100 mg Plus Paclitaxel 80 mg Per m2|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
198265|NCT01572675|B3|Baseline|Total|Total of all reporting groups
198266|NCT01572675|B2|Baseline|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198267|NCT01572675|B1|Baseline|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198268|NCT01572675|P2|Participant Flow|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198269|NCT01572675|P1|Participant Flow|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198421|NCT01571453|O1|Outcome|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
198422|NCT01571453|O2|Outcome|Venlafaxine|Venlafaxine extended release: 150 mg/day
198272|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198273|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198274|NCT01572675|O3|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198275|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198276|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198277|NCT01572675|O2|Outcome|Group Celebrex®|Participants who either previously received Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198278|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who either previously received Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198279|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198280|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198281|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198282|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198283|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198284|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198285|NCT01572675|O2|Outcome|Group Celebrex®|Participants who either previously received Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198286|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who either previously received Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198287|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198288|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198289|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198290|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198291|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198292|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198293|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198294|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198295|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198296|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198297|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198298|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198299|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198300|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198301|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198302|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198303|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198304|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198305|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198306|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198307|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198308|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198309|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198310|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198311|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198312|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198313|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198314|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198315|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198316|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198317|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198318|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198319|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198320|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198423|NCT01571453|O1|Outcome|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
198424|NCT01571453|E2|Reported Event|Venlafaxine|Venlafaxine extended release: 150 mg/day
198321|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198322|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198323|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198324|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198325|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198326|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198327|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198328|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198329|NCT01572675|O4|Outcome|More Than One Year|Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated for more than one year
198330|NCT01572675|O3|Outcome|From Three Months to One Year|Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated from three months to one year
198331|NCT01572675|O2|Outcome|From One to Three Months|Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated from one to three months total
198332|NCT01572675|O1|Outcome|Up to Thirty Days|Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated for ≤ 30 days
198333|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198334|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198335|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198336|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198337|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198338|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198339|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198340|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198341|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198342|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198343|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198344|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198345|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198425|NCT01571453|E1|Reported Event|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
208268|NCT01534416|O1|Outcome|Bupivacaine Narcotics Use|
198346|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198347|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198348|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198349|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198350|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198351|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198352|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198353|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198354|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198355|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198356|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198357|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198358|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198359|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198360|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198361|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198362|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198363|NCT01572675|E2|Reported Event|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198364|NCT01572675|E1|Reported Event|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
198365|NCT01572389|B3|Baseline|Total|Total of all reporting groups
198366|NCT01572389|B2|Baseline|Arm 2: EUC|"The Enhanced Usual Care (EUC) group will serve as a concurrent control group to compare to the intervention arm of the study. Participants are screened for diabetes self-management behaviors and control and for active depressive and anxiety symptoms. Primary care providers are alerted of the patients' status and given decision support to enhance care for these uncontrolled conditions.~Enhanced Usual Care: All participants receive usual VA primary care plus a dedicated screening for diabetes control and clinically significant depressive symptoms. Patients and primary care providers are notified of these results and given recommendations for usual care."
198367|NCT01572389|B1|Baseline|Arm 1: HOPE|"The Healthy Outcomes through Patient Empowerment (HOPE) intervention group is the intervention arm which will employ behavioral health coaching telephone sessions. Tele-coaching is a theoretically grounded, structured processes guided by intervention manuals.~Healthy Outcomes through Patient Empowerment (HOPE): HOPE participants will receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period followed by usual primary care during the subsequent 6 months maintenance period."
198384|NCT01572298|O1|Outcome|Allograft Alone|"guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)~allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws"
198660|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
198368|NCT01572389|P2|Participant Flow|Arm 2: EUC|"The Enhanced Usual Care (EUC) group will serve as a concurrent control group to compare to the intervention arm of the study. Participants are screened for diabetes self-management behaviors and control and for active depressive and anxiety symptoms. Primary care providers are alerted of the patients' status and given decision support to enhance care for these uncontrolled conditions.~Enhanced Usual Care: All participants receive usual VA primary care plus a dedicated screening for diabetes control and clinically significant depressive symptoms. Patients and primary care providers are notified of these results and given recommendations for usual care."
198369|NCT01572389|P1|Participant Flow|Arm 1: HOPE|"The Healthy Outcomes through Patient Empowerment (HOPE) intervention group is the intervention arm which will employ behavioral health coaching telephone sessions. Tele-coaching is a theoretically grounded, structured processes guided by intervention manuals.~Healthy Outcomes through Patient Empowerment (HOPE): HOPE participants will receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period followed by usual primary care during the subsequent 6 months maintenance period."
198370|NCT01572389|O2|Outcome|Arm 2: EUC|"The Enhanced Usual Care (EUC) group will serve as a concurrent control group to compare to the intervention arm of the study. Participants are screened for diabetes self-management behaviors and control and for active depressive and anxiety symptoms. Primary care providers are alerted of the patients' status and given decision support to enhance care for these uncontrolled conditions.~Enhanced Usual Care: All participants receive usual VA primary care plus a dedicated screening for diabetes control and clinically significant depressive symptoms. Patients and primary care providers are notified of these results and given recommendations for usual care."
198371|NCT01572389|O1|Outcome|Arm 1: HOPE|"The Healthy Outcomes through Patient Empowerment (HOPE) intervention group is the intervention arm which will employ behavioral health coaching telephone sessions. Tele-coaching is a theoretically grounded, structured processes guided by intervention manuals.~Healthy Outcomes through Patient Empowerment (HOPE): HOPE participants will receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period followed by usual primary care during the subsequent 6 months maintenance period."
198372|NCT01572389|O2|Outcome|Arm 2: EUC|"The Enhanced Usual Care (EUC) group will serve as a concurrent control group to compare to the intervention arm of the study. Participants are screened for diabetes self-management behaviors and control and for active depressive and anxiety symptoms. Primary care providers are alerted of the patients' status and given decision support to enhance care for these uncontrolled conditions.~Enhanced Usual Care: All participants receive usual VA primary care plus a dedicated screening for diabetes control and clinically significant depressive symptoms. Patients and primary care providers are notified of these results and given recommendations for usual care."
198373|NCT01572389|O1|Outcome|Arm 1: HOPE|"The Healthy Outcomes through Patient Empowerment (HOPE) intervention group is the intervention arm which will employ behavioral health coaching telephone sessions. Tele-coaching is a theoretically grounded, structured processes guided by intervention manuals.~Healthy Outcomes through Patient Empowerment (HOPE): HOPE participants will receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period followed by usual primary care during the subsequent 6 months maintenance period."
198374|NCT01572389|E2|Reported Event|Arm 2: EUC|"The Enhanced Usual Care (EUC) group will serve as a concurrent control group to compare to the intervention arm of the study. Participants are screened for diabetes self-management behaviors and control and for active depressive and anxiety symptoms. Primary care providers are alerted of the patients' status and given decision support to enhance care for these uncontrolled conditions.~Enhanced Usual Care: All participants receive usual VA primary care plus a dedicated screening for diabetes control and clinically significant depressive symptoms. Patients and primary care providers are notified of these results and given recommendations for usual care."
198375|NCT01572389|E1|Reported Event|Arm 1: HOPE|"The Healthy Outcomes through Patient Empowerment (HOPE) intervention group is the intervention arm which will employ behavioral health coaching telephone sessions. Tele-coaching is a theoretically grounded, structured processes guided by intervention manuals.~Healthy Outcomes through Patient Empowerment (HOPE): HOPE participants will receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period followed by usual primary care during the subsequent 6 months maintenance period."
198376|NCT01572298|B3|Baseline|Total|Total of all reporting groups
198377|NCT01572298|B2|Baseline|Allograft Combined With Autograft|"guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)~allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws"
198378|NCT01572298|B1|Baseline|Allograft Alone|"guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)~allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws"
198379|NCT01572298|P2|Participant Flow|Allograft Combined With Autograft|"guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)~allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws"
198380|NCT01572298|P1|Participant Flow|Allograft Alone|"guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)~allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws"
198381|NCT01572298|O2|Outcome|Allograft With Autograft|"guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)~allograft with autograft: use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws"
198382|NCT01572298|O1|Outcome|Allograft Alone|"guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)~allograft alone: use of MinerOss allograft plus Alloderm GBR membrane and tenting screws"
198383|NCT01572298|O2|Outcome|Allograft Combined With Autograft|"guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)~allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws"
198407|NCT01571453|B3|Baseline|Total|Total of all reporting groups
198385|NCT01572298|E2|Reported Event|Allograft Combined With Autograft|"guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)~allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws"
198386|NCT01572298|E1|Reported Event|Allograft Alone|"guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)~allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws"
198387|NCT01572207|B3|Baseline|Total|Total of all reporting groups
198388|NCT01572207|B2|Baseline|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
198389|NCT01572207|B1|Baseline|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
198390|NCT01572207|P2|Participant Flow|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
198391|NCT01572207|P1|Participant Flow|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
198392|NCT01572207|O2|Outcome|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
198393|NCT01572207|O1|Outcome|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
198394|NCT01572207|O2|Outcome|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
198395|NCT01572207|O1|Outcome|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
198396|NCT01572207|O2|Outcome|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
198397|NCT01572207|O1|Outcome|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
198398|NCT01572207|E2|Reported Event|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
198399|NCT01572207|E1|Reported Event|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
198400|NCT01571557|B1|Baseline|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
198401|NCT01571557|P1|Participant Flow|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
198402|NCT01571557|O1|Outcome|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
198403|NCT01571557|O1|Outcome|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
198404|NCT01571557|O1|Outcome|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
198405|NCT01571557|O1|Outcome|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
198406|NCT01571557|E1|Reported Event|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
198426|NCT01571362|B1|Baseline|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198427|NCT01571362|P3|Participant Flow|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198428|NCT01571362|P2|Participant Flow|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198429|NCT01571362|P1|Participant Flow|Open ALO-02|Participants received AL0-02 extended-release capsules, orally (PO), twice daily (BID), at total daily doses of oxycodone from 20 to 160 milligrams (mg) in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198430|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198431|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198432|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198433|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198434|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198435|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198436|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198437|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198438|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198465|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198661|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
198662|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
198439|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198440|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198441|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198442|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198443|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198444|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198445|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198446|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198447|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198448|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198449|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198450|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198451|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198452|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198453|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198454|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198455|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198456|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198457|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198458|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198459|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198460|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198461|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198462|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198463|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198464|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198663|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
198664|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
198466|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198467|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198468|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198469|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198470|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198471|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198472|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198473|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198474|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198475|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198476|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198477|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198478|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198479|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198480|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198481|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198482|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198483|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198484|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198485|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198486|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198487|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198488|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198489|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198490|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198491|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198492|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198522|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198523|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198493|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198494|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198495|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198496|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198497|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198498|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198499|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198500|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198501|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198502|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198503|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198504|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198505|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198506|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198507|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
208936|NCT01532128|O1|Outcome|Rasagiline Alone|Rasagiline alone.
198508|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198509|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198510|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198511|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198512|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198513|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198514|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198515|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198516|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198517|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198518|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198519|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198520|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198521|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198524|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198525|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198526|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198527|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198528|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198529|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198530|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198531|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198532|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198533|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198534|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198535|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198550|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198665|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
198666|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
198536|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198537|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198538|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198539|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198540|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198541|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198542|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198543|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198544|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198545|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198546|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198547|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198548|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198549|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198551|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198552|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198553|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198554|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198555|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198556|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198557|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198558|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198559|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198560|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198561|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198667|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
198668|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
198669|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
199815|NCT01566773|O8|Outcome|Spiriva® Handihaler®|Spiriva® Handihaler® (Tiotropium Bromide).
198562|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198563|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198564|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198565|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198566|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198567|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198568|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198569|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198570|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198571|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198572|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198610|NCT01571284|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
198573|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198574|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198575|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198576|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198577|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198578|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198579|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198580|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198581|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198582|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198583|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198584|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198611|NCT01571284|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
198585|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198586|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198587|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198588|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198589|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198590|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198591|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198592|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198593|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198594|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198595|NCT01571362|E3|Reported Event|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
198656|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
198657|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
198658|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
198783|NCT01569828|B3|Baseline|Total|Total of all reporting groups
198596|NCT01571362|E2|Reported Event|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
198597|NCT01571362|E1|Reported Event|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
198598|NCT01571284|B1|Baseline|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
198599|NCT01571284|P1|Participant Flow|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg intravenous (IV) infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until disease progression (DP), unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
198600|NCT01571284|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
198601|NCT01571284|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
198602|NCT01571284|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
198603|NCT01571284|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
198604|NCT01571284|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
198605|NCT01571284|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
198606|NCT01571284|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
198607|NCT01571284|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
198608|NCT01571284|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
198609|NCT01571284|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
198659|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
199816|NCT01566773|O7|Outcome|Placebo MDI|Placebo MDI.
198612|NCT01571284|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
198613|NCT01571284|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
198614|NCT01571284|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
198615|NCT01571284|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
198616|NCT01571284|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
198617|NCT01571284|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
198618|NCT01571284|E1|Reported Event|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
198619|NCT01571232|B3|Baseline|Total|Total of all reporting groups
198620|NCT01571232|B2|Baseline|Avastin|"Patients in this group receive Avastin Q1 month for 5 months.~intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments."
198621|NCT01571232|B1|Baseline|Ozurdex|"Patients in this group receive Ozurdex at initial visit and at month 4~dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)"
198622|NCT01571232|P2|Participant Flow|Avastin|"Patients in this group receive Avastin Q1 month for 5 months.~intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments."
198623|NCT01571232|P1|Participant Flow|Ozurdex|"Patients in this group receive Ozurdex at initial visit and at month 4~dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)"
198624|NCT01571232|O2|Outcome|Avastin|"Patients in this group receive Avastin Q1 month for 5 months.~intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments."
198625|NCT01571232|O1|Outcome|Ozurdex|"Patients in this group receive Ozurdex at initial visit and at month 4~dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)"
198626|NCT01571232|O2|Outcome|Avastin|"Patients in this group receive Avastin Q1 month for 5 months.~intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments."
198627|NCT01571232|O1|Outcome|Ozurdex|"Patients in this group receive Ozurdex at initial visit and at month 4~dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)"
198628|NCT01571232|O2|Outcome|Avastin|"Patients in this group receive Avastin Q1 month for 5 months.~intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments."
198629|NCT01571232|O1|Outcome|Ozurdex|"Patients in this group receive Ozurdex at initial visit and at month 4~dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)"
198630|NCT01571232|E2|Reported Event|Avastin|"Patients in this group receive Avastin Q1 month for 5 months.~intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments."
198631|NCT01571232|E1|Reported Event|Ozurdex|"Patients in this group receive Ozurdex at initial visit and at month 4~dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)"
198632|NCT01570751|B3|Baseline|Total|Total of all reporting groups
198633|NCT01570751|B2|Baseline|IGlar/IDeg|The subjects in this arm for treatment period A received IGlar OD (100 U/mL in SoloStar® pen) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IDeg OD (200 U/mL in pre-filled pen device) for 16 weeks (treatment period B). Subjects were crossed over to IDeg without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
199817|NCT01566773|O6|Outcome|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
198634|NCT01570751|B1|Baseline|IDeg/IGlar|The subjects in this arm for treatment period A received IDeg OD (200 U/mL in pre-filled pen device) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IGlar OD (100 U/mL in SoloStar® pen) for 16 weeks (treatment period B). Subjects were crossed over to IGlar without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
198635|NCT01570751|P2|Participant Flow|IGlar/IDeg|The subjects in this arm for treatment period A received IGlar OD (100 U/mL in SoloStar® pen) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IDeg OD (200 U/mL in pre-filled pen device) for 16 weeks (treatment period B). Subjects were crossed over to IDeg without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
198636|NCT01570751|P1|Participant Flow|IDeg/IGlar|The subjects in this arm for treatment period A received IDeg OD (200 U/mL in pre-filled pen device) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IGlar OD (100 U/mL in SoloStar® pen) for 16 weeks (treatment period B). Subjects were crossed over to IGlar without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
198637|NCT01570751|O2|Outcome|IGlar|Subjects received IGlar OD (100 U/mL in Solostar® pen) subcutaneously (under the skin)for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IDeg, subjects either received IGlar in treatment period A or treatment period B.
198638|NCT01570751|O1|Outcome|IDeg|Subjects received IDeg OD (200 U/mL in prefilled pen device) subcutaneously (under the skin) for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IGlar, subjects either received IDeg in treatment period A or treatment period B.
198639|NCT01570751|O2|Outcome|IGlar/IDeg|The subjects in this arm for treatment period A received IGlar OD (100 U/mL in SoloStar® pen) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IDeg OD (200 U/mL in pre-filled pen device) for 16 weeks (treatment period B). Subjects were crossed over to IDeg without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
198640|NCT01570751|O1|Outcome|IDeg/IGlar|The subjects in this arm for treatment period A received IDeg OD (200 U/mL in pre-filled pen device) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IGlar OD (100 U/mL in SoloStar® pen) for 16 weeks (treatment period B). Subjects were crossed over to IGlar without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
198641|NCT01570751|O2|Outcome|IGlar|Subjects received IGlar OD (100 U/mL in Solostar® pen) subcutaneously (under the skin)for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IDeg, subjects either received IGlar in treatment period A or treatment period B.
198642|NCT01570751|O1|Outcome|IDeg|Subjects received IDeg OD (200 U/mL in prefilled pen device) subcutaneously (under the skin) for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IGlar, subjects either received IDeg in treatment period A or treatment period B.
198643|NCT01570751|O2|Outcome|IGlar/IDeg|The subjects in this arm for treatment period A received IGlar OD (100 U/mL in SoloStar® pen) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IDeg OD (200 U/mL in pre-filled pen device) for 16 weeks (treatment period B). Subjects were crossed over to IDeg without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
198644|NCT01570751|O1|Outcome|IDeg/IGlar|The subjects in this arm for treatment period A received IDeg OD (200 U/mL in pre-filled pen device) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IGlar OD (100 U/mL in SoloStar® pen) for 16 weeks (treatment period B). Subjects were crossed over to IGlar without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
198645|NCT01570751|O2|Outcome|IGlar|Subjects received IGlar OD (100 U/mL in Solostar® pen) subcutaneously (under the skin)for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IDeg, subjects either received IGlar in treatment period A or treatment period B.
198646|NCT01570751|O1|Outcome|IDeg|Subjects received IDeg OD (200 U/mL in prefilled pen device) subcutaneously (under the skin) for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IGlar, subjects either received IDeg in treatment period A or treatment period B.
198647|NCT01570751|O2|Outcome|IGlar|Subjects received IGlar OD (100 U/mL in Solostar® pen) subcutaneously (under the skin)for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IDeg, subjects either received IGlar in treatment period A or treatment period B.
198648|NCT01570751|O1|Outcome|IDeg|Subjects received IDeg OD (200 U/mL in prefilled pen device) subcutaneously (under the skin) for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IGlar, subjects either received IDeg in treatment period A or treatment period B.
198649|NCT01570751|E2|Reported Event|IGlar|Subjects received IGlar OD (100 U/mL in Solostar® pen) subcutaneously (under the skin)for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IDeg, subjects either received IGlar in treatment period A or treatment period B.
198650|NCT01570751|E1|Reported Event|IDeg|Subjects received IDeg OD (200 U/mL in prefilled pen device) subcutaneously (under the skin) for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IGlar, subjects either received IDeg in treatment period A or treatment period B.
198651|NCT01570686|B3|Baseline|Total|Total of all reporting groups
198652|NCT01570686|B2|Baseline|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
198653|NCT01570686|B1|Baseline|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
198654|NCT01570686|P2|Participant Flow|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
198655|NCT01570686|P1|Participant Flow|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
198670|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
198671|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
198672|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
198673|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
198674|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
198675|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
198676|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
198677|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
198678|NCT01570686|E2|Reported Event|Aliskiren 300 mg (Fasted)|Aliskiren 300 mg once daily taken after after an overnight fast
198679|NCT01570686|E1|Reported Event|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
198680|NCT01570634|B1|Baseline|Open Label CASAD|Treatment with CASAD for 14 days
198681|NCT01570634|P1|Participant Flow|Open Label CASAD|Treatment with Calcium Aluminosilicate Anti-Diarrheal (CASAD) for 14 days
198682|NCT01570634|O1|Outcome|Open Label CASAD|Treatment with CASAD for 14 days
198683|NCT01570634|O1|Outcome|Open Label CASAD|Treatment with CASAD for 14 days
198684|NCT01570634|O1|Outcome|Open Label CASAD|Treatment with CASAD for 14 days
198685|NCT01570634|O1|Outcome|Open Label CASAD|Treatment with CASAD for 14 days
198686|NCT01570634|O1|Outcome|Open Label CASAD|Treatment with CASAD for 14 days
198687|NCT01570634|E1|Reported Event|Open Label CASAD|Treatment with CASAD for 14 days
198688|NCT01570309|B3|Baseline|Total|Total of all reporting groups
198689|NCT01570309|B2|Baseline|Sugar Pill|Matching placebo
198690|NCT01570309|B1|Baseline|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
198691|NCT01570309|P2|Participant Flow|Sugar Pill|Matching placebo
198692|NCT01570309|P1|Participant Flow|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
198693|NCT01570309|O2|Outcome|Sugar Pill|Matching placebo
198694|NCT01570309|O1|Outcome|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
198695|NCT01570309|O2|Outcome|Placebo|Sugar Pill
198696|NCT01570309|O1|Outcome|Active Therapy|Ergocalciferol 50,000 U q weekly x 12 weeks
198697|NCT01570309|O2|Outcome|Sugar Pill|Matching placebo
198698|NCT01570309|O1|Outcome|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
198699|NCT01570309|O2|Outcome|Sugar Pill|Matching Placebo
198700|NCT01570309|O1|Outcome|Active|Ergocalciferal 50,000 U qweekly x 12 weeks
198701|NCT01570309|O2|Outcome|Sugar Pill|Matching placebo
198702|NCT01570309|O1|Outcome|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
198703|NCT01570309|E2|Reported Event|Sugar Pill|Matching placebo
198704|NCT01570309|E1|Reported Event|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
198705|NCT01570244|B1|Baseline|All Subjects|The trial was a nonrandomised, noncontrolled, open-label, 2-period fixed-sequence trial to evaluate the possible effect of multiple doses of faldaprevir on the multiple-dose pharmacokinetics of a combination of ethinylestradiol and levonorgestrel. The trial was to be performed in 16 healthy female volunteers.
198706|NCT01570244|P1|Participant Flow|All Subjects|"The trial was a nonrandomised, noncontrolled, open-label, 2-period fixed-sequence trial to evaluate the possible effect of multiple doses of faldaprevir on the multiple-dose pharmacokinetics of a combination of ethinylestradiol and levonorgestrel. The trial was to be performed in 16 healthy female volunteers.~Period 1: Microgynon (150 μg Ethinylestradiol+30 μg Levonorgestrel) tablets.~Period 2: Microgynon tablets and Faldaprevir."
198707|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
198708|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
198709|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
198710|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
198711|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
198712|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
198713|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
198714|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
198715|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
198716|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
198717|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
198718|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
198719|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
198720|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
198721|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
198722|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
198723|NCT01570244|E2|Reported Event|Microgynon + BI 201335|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
198724|NCT01570244|E1|Reported Event|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
198725|NCT01570192|B3|Baseline|Total|Total of all reporting groups
198726|NCT01570192|B2|Baseline|I.V. Meropenem|"Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat Gram-positive pathogens.~**NOTE: Empiric MRSA coverage is allowed in both arms. This therapy is advised for any subjects with known or suspected MRSA entering the study. Once microbiologic results are available, this coverage may be discontinued at the investigator's discretion.~I.V. Meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage~Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage."
198727|NCT01570192|B1|Baseline|IV Meropenem; Parenteral Aminoglycoside|"Subjects assigned to this group will receive:~IV meropenem (2 g infused over 3 hrs q 8 hr);~a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)~tobramycin nebulization~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat potential Gram-positive pathogens.~IV meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h: a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)~Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage.~tobramycin nebulization: tobramycin nebulization 600mg/day"
198728|NCT01570192|P2|Participant Flow|I.V. Meropenem|"Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat Gram-positive pathogens.~**NOTE: Empiric MRSA coverage is allowed in both arms. This therapy is advised for any subjects with known or suspected MRSA entering the study. Once microbiologic results are available, this coverage may be discontinued at the investigator's discretion.~I.V. Meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage~Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage."
198729|NCT01570192|P1|Participant Flow|IV Meropenem; Parenteral Aminoglycoside|"Subjects assigned to this group will receive:~IV meropenem (2 g infused over 3 hrs q 8 hr);~a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)~tobramycin nebulization~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat potential Gram-positive pathogens.~IV meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h: a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)~Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage.~tobramycin nebulization: tobramycin nebulization 600mg/day"
198730|NCT01570192|O4|Outcome|m-MITT Group - Meropenem Only|Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
198731|NCT01570192|O3|Outcome|m-MITT Group - Meropenem Plus Aminoglycoside|Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
198732|NCT01570192|O2|Outcome|ME Group - Meropenem Only|Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population.
198733|NCT01570192|O1|Outcome|ME Group - Meropenem Plus Aminoglycoside|Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population
198734|NCT01570192|O4|Outcome|m-MITT Group - Meropenem Only|Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
198735|NCT01570192|O3|Outcome|m-MITT Group - Meropenem Plus Aminoglycoside|Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
198736|NCT01570192|O2|Outcome|ME Group - Meropenem Only|Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population.
198737|NCT01570192|O1|Outcome|ME Group - Meropenem Plus Aminoglycoside|Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population
198738|NCT01570192|O4|Outcome|m-MITT Group - Meropenem Only|Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
198739|NCT01570192|O3|Outcome|m-MITT Group - Meropenem Plus Aminoglycoside|Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
198740|NCT01570192|O2|Outcome|ME Group - Meropenem Only|Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population.
198741|NCT01570192|O1|Outcome|ME Group - Meropenem Plus Aminoglycoside|Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population
198742|NCT01570192|O4|Outcome|m-MITT Group - Meropenem Only|Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
198743|NCT01570192|O3|Outcome|m-MITT Group - Meropenem Plus Aminoglycoside|Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
198744|NCT01570192|O2|Outcome|ME Group - Meropenem Only|Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population.
198745|NCT01570192|O1|Outcome|ME Group - Meropenem Plus Aminoglycoside|Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population
198746|NCT01570192|O4|Outcome|m-MITT Group - Meropenem Only|Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
198747|NCT01570192|O3|Outcome|m-MITT Group - Meropenem Plus Aminoglycoside|Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
198748|NCT01570192|O2|Outcome|ME Group - Meropenem Only|Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population.
198749|NCT01570192|O1|Outcome|ME Group - Meropenem Plus Aminoglycoside|Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population
198750|NCT01570192|O4|Outcome|m-MITT Group - Meropenem Only|Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
198751|NCT01570192|O3|Outcome|m-MITT Group - Meropenem Plus Aminoglycoside|Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
198752|NCT01570192|O2|Outcome|ME Group - Meropenem Only|Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population.
198753|NCT01570192|O1|Outcome|ME Group - Meropenem Plus Aminoglycoside|Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population
198754|NCT01570192|O4|Outcome|m-MITT Group - Meropenem Only|Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
198755|NCT01570192|O3|Outcome|m-MITT Group - Meropenem Plus Aminoglycoside|Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
198756|NCT01570192|O2|Outcome|ME Group - Meropenem Only|Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population.
198757|NCT01570192|O1|Outcome|ME Group - Meropenem Plus Aminoglycoside|Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population
198758|NCT01570192|O4|Outcome|m-MITT Group - Meropenem Only|Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
198759|NCT01570192|O3|Outcome|m-MITT Group - Meropenem Plus Aminoglycoside|Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
198760|NCT01570192|O2|Outcome|MEGroup - Meropenem Only|Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population.
198761|NCT01570192|O1|Outcome|ME Group - Meropenem Plus Aminoglycoside|Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population
198762|NCT01570192|O2|Outcome|I.V. Meropenem|"Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat Gram-positive pathogens.~**NOTE: Empiric MRSA coverage is allowed in both arms. This therapy is advised for any subjects with known or suspected MRSA entering the study. Once microbiologic results are available, this coverage may be discontinued at the investigator's discretion.~I.V. Meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage~Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage."
198763|NCT01570192|O1|Outcome|IV Meropenem; Parenteral Aminoglycoside|"Subjects assigned to this group will receive:~IV meropenem (2 g infused over 3 hrs q 8 hr);~a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)~tobramycin nebulization~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat potential Gram-positive pathogens.~IV meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h: a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)~Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage.~tobramycin nebulization: tobramycin nebulization 600mg/day"
198764|NCT01570192|E2|Reported Event|I.V. Meropenem|"Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat Gram-positive pathogens.~**NOTE: Empiric MRSA coverage is allowed in both arms. This therapy is advised for any subjects with known or suspected MRSA entering the study. Once microbiologic results are available, this coverage may be discontinued at the investigator's discretion.~I.V. Meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage~Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage."
198824|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
198825|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
198765|NCT01570192|E1|Reported Event|IV Meropenem; Parenteral Aminoglycoside|"Subjects assigned to this group will receive:~IV meropenem (2 g infused over 3 hrs q 8 hr);~a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)~tobramycin nebulization~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat potential Gram-positive pathogens.~IV meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h: a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)~Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage.~tobramycin nebulization: tobramycin nebulization 600mg/day"
198766|NCT01569841|B1|Baseline|Full Analysis Set|The full analysis set (FAS) included all randomised subjects.
198767|NCT01569841|P2|Participant Flow|IGlar/IDeg|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.~Upon completing the 4-week run-in period, subjects randomised to the IGlar/IDeg treatment sequence received an morning dose of IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks in treatment Period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks."
198768|NCT01569841|P1|Participant Flow|IDeg/IGlar|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.~Upon completing the 4-week run-in period, subjects randomised to the IDeg/IGlar treatment sequence received an morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) along with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks in treatment period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IGlar OD (100 U/mL, SoloStar® prefilled pen) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks."
198769|NCT01569841|O2|Outcome|IGlar|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks."
198770|NCT01569841|O1|Outcome|IDeg|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks."
198771|NCT01569841|O2|Outcome|IGlar|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks."
198772|NCT01569841|O1|Outcome|IDeg|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks."
198773|NCT01569841|O2|Outcome|IGlar/IDeg|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.~Upon completing the 4-week run-in period, subjects randomised to the IGlar/IDeg treatment sequence received an morning dose of IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks in treatment Period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks."
198826|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
198827|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
198828|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
198774|NCT01569841|O1|Outcome|IDeg/IGlar|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.~Upon completing the 4-week run-in period, subjects randomised to the IDeg/IGlar treatment sequence received an morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) along with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks in treatment period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IGlar OD (100 U/mL, SoloStar® prefilled pen) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks."
198775|NCT01569841|O2|Outcome|IGlar/IDeg|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.~Upon completing the 4-week run-in period, subjects randomised to the IGlar/IDeg treatment sequence received an morning dose of IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks in treatment Period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks."
198776|NCT01569841|O1|Outcome|IDeg/IGlar|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.~Upon completing the 4-week run-in period, subjects randomised to the IDeg/IGlar treatment sequence received an morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) along with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks in treatment period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IGlar OD (100 U/mL, SoloStar® prefilled pen) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks."
198777|NCT01569841|O2|Outcome|IGlar|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks."
198778|NCT01569841|O1|Outcome|IDeg|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks."
198779|NCT01569841|O2|Outcome|IGlar|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks."
198780|NCT01569841|O1|Outcome|IDeg|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks."
198781|NCT01569841|E2|Reported Event|IGlar|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks."
198782|NCT01569841|E1|Reported Event|IDeg|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks."
198784|NCT01569828|B2|Baseline|Matched Healthy Volunteers|"All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min.~Once daily administration of 400 mg LCZ696 p.o. for 5 days"
198785|NCT01569828|B1|Baseline|Severe Renal Impaired Subjects|"Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement.~Once daily administration of 400 mg LCZ696 p.o. for 5 days"
198786|NCT01569828|P2|Participant Flow|Matched Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min.Once daily administration of 400 mg LCZ696 p.o. for 5 days
198787|NCT01569828|P1|Participant Flow|Severe Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
198788|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
198789|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement.Once daily administration of 400 mg LCZ696 p.o. for 5 days
198790|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
198791|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
198792|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
198793|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
198794|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
198795|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
198796|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
198797|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
198798|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
198799|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
198800|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
198801|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
198802|NCT01569828|E2|Reported Event|Matched Healthy Volunteers|
198803|NCT01569828|E1|Reported Event|Severe Renal Impaired Patients|
198804|NCT01569815|B5|Baseline|Total|Total of all reporting groups
198805|NCT01569815|B4|Baseline|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
198806|NCT01569815|B3|Baseline|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
198807|NCT01569815|B2|Baseline|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
198808|NCT01569815|B1|Baseline|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
198809|NCT01569815|P4|Participant Flow|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
198810|NCT01569815|P3|Participant Flow|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
198811|NCT01569815|P2|Participant Flow|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
198812|NCT01569815|P1|Participant Flow|Mild Renal Impaired|LCZ696 400 mg once daily for 5 days
198813|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
198814|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
198815|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
198816|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
198817|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
198818|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
198819|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
198820|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
198821|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
198822|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
198823|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
198962|NCT01569438|O2|Outcome|Sugar Pill|Sugar Pill: Placebo
198829|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
198830|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
198831|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
198832|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
198833|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
198834|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
198835|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
198836|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
198837|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
198838|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
198839|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
198840|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
198841|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
198842|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
198843|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
198844|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
198845|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
198846|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
198847|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
198848|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
198849|NCT01569815|E5|Reported Event|LCZ696 400 mg - All Healthy Subjects|LCZ696 400 mg - All healthy subjects
198850|NCT01569815|E4|Reported Event|LCZ696 400 mg - Moderate - Matched Healthy Subjects|LCZ696 400 mg - Moderate - Matched healthy subjects
198851|NCT01569815|E3|Reported Event|LCZ696 400 mg - Moderate - Renal Impaired Patients|LCZ696 400 mg - Moderate - Renal impaired patients
198852|NCT01569815|E2|Reported Event|LCZ696 400 mg - Mild - Matched Healthy Subjects|LCZ696 400 mg - Mild - Matched healthy subjects
198853|NCT01569815|E1|Reported Event|LCZ696 400 mg - Mild - Renal Impaired Patients|LCZ696 400 mg - Mild - Renal impaired patients
198854|NCT01569763|B3|Baseline|Total|Total of all reporting groups
198855|NCT01569763|B2|Baseline|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
198856|NCT01569763|B1|Baseline|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Minerva Endometrial Ablation system
198857|NCT01569763|P2|Participant Flow|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
198858|NCT01569763|P1|Participant Flow|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system
198859|NCT01569763|O2|Outcome|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
198860|NCT01569763|O1|Outcome|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system
198861|NCT01569763|O2|Outcome|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
198862|NCT01569763|O1|Outcome|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system
198863|NCT01569763|O2|Outcome|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
198864|NCT01569763|O1|Outcome|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system
198865|NCT01569763|E2|Reported Event|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
198866|NCT01569763|E1|Reported Event|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system
198867|NCT01569607|B3|Baseline|Total|Total of all reporting groups
198868|NCT01569607|B2|Baseline|Sham Stimulation|"Participants were randomized to receive sham stimulation.~Sham stimulation: Sham stimulation"
198869|NCT01569607|B1|Baseline|Hebbian-type Stimulation|"Participants were randomized to receive motor training with Hebbian-type stimulation.~Repetitive Transcranial Magnetic Stimulation (rTMS): Training sessions for 5 days in a row"
198870|NCT01569607|P2|Participant Flow|Sham Stimulation|"Participants were randomized to receive sham stimulation.~Sham stimulation: Sham stimulation"
198871|NCT01569607|P1|Participant Flow|Hebbian-type Stimulation|"Participants were randomized to receive motor training with Hebbian-type stimulation.~Repetitive Transcranial Magnetic Stimulation (rTMS): Training sessions for 5 days in a row"
198872|NCT01569607|O2|Outcome|Sham Stimulation|"Participants were randomized to receive sham stimulation.~Sham stimulation: Sham stimulation"
198873|NCT01569607|O1|Outcome|Hebbian-type Stimulation|"Participants were randomized to receive motor training with Hebbian-type stimulation.~Repetitive Transcranial Magnetic Stimulation (rTMS): Training sessions for 5 days in a row"
198874|NCT01569607|O2|Outcome|Sham Stimulation|"Participants were randomized to receive sham stimulation.~Sham stimulation: Sham stimulation"
198875|NCT01569607|O1|Outcome|Hebbian-type Stimulation|"Participants were randomized to receive motor training with Hebbian-type stimulation.~Repetitive Transcranial Magnetic Stimulation (rTMS): Training sessions for 5 days in a row"
198876|NCT01569607|O2|Outcome|Sham Stimulation|"Participants were randomized to receive sham stimulation.~Sham stimulation: Sham stimulation"
198877|NCT01569607|O1|Outcome|Hebbian-type Stimulation|"Participants were randomized to receive motor training with Hebbian-type stimulation.~Repetitive Transcranial Magnetic Stimulation (rTMS): Training sessions for 5 days in a row"
198963|NCT01569438|O1|Outcome|Gefapixant|Gefapixant: BID
198878|NCT01569607|O2|Outcome|Sham Stimulation|"Participants were randomized to receive sham stimulation.~Sham stimulation: Sham stimulation"
198879|NCT01569607|O1|Outcome|Hebbian-type Stimulation|"Participants were randomized to receive motor training with Hebbian-type stimulation.~Repetitive Transcranial Magnetic Stimulation (rTMS): Training sessions for 5 days in a row"
198880|NCT01569607|O2|Outcome|Sham Stimulation|"Participants were randomized to receive sham stimulation.~Sham stimulation: Sham stimulation"
198881|NCT01569607|O1|Outcome|Hebbian-type Stimulation|"Participants were randomized to receive motor training with Hebbian-type stimulation.~Repetitive Transcranial Magnetic Stimulation (rTMS): Training sessions for 5 days in a row"
198882|NCT01569607|O2|Outcome|Sham Stimulation|"Participants were randomized to receive sham stimulation.~Sham stimulation: Sham stimulation"
198883|NCT01569607|O1|Outcome|Hebbian-type Stimulation|"Participants were randomized to receive motor training with Hebbian-type stimulation.~Repetitive Transcranial Magnetic Stimulation (rTMS): Training sessions for 5 days in a row"
198884|NCT01569607|O2|Outcome|Sham Stimulation|"Participants were randomized to receive sham stimulation.~Sham stimulation: Sham stimulation"
198885|NCT01569607|O1|Outcome|Hebbian-type Stimulation|"Participants were randomized to receive motor training with Hebbian-type stimulation.~Repetitive Transcranial Magnetic Stimulation (rTMS): Training sessions for 5 days in a row"
198886|NCT01569607|O2|Outcome|Sham Stimulation|"Participants were randomized to receive sham stimulation.~Sham stimulation: Sham stimulation"
198887|NCT01569607|O1|Outcome|Hebbian-type Stimulation|"Participants were randomized to receive motor training with Hebbian-type stimulation.~Repetitive Transcranial Magnetic Stimulation (rTMS): Training sessions for 5 days in a row"
198888|NCT01569607|O2|Outcome|Sham Stimulation|"Participants were randomized to receive sham stimulation.~Sham stimulation: Sham stimulation"
198889|NCT01569607|O1|Outcome|Hebbian-type Stimulation|"Participants were randomized to receive motor training with Hebbian-type stimulation.~Repetitive Transcranial Magnetic Stimulation (rTMS): Training sessions for 5 days in a row"
198890|NCT01569607|E2|Reported Event|Sham Stimulation|"Participants were randomized to receive sham stimulation.~Sham stimulation: Sham stimulation"
198891|NCT01569607|E1|Reported Event|Hebbian-type Stimulation|"Participants were randomized to receive motor training with Hebbian-type stimulation.~Repetitive Transcranial Magnetic Stimulation (rTMS): Training sessions for 5 days in a row"
198892|NCT01569568|B3|Baseline|Total|Total of all reporting groups
198893|NCT01569568|B2|Baseline|Healthy Controls|"males and females ages 7-60 years who are healthy controls~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
198894|NCT01569568|B1|Baseline|Subjects With OTCD|"males and females ages 7-60 years with OTCD~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
198895|NCT01569568|P2|Participant Flow|Healthy Controls|"males and females ages 7-60 years who are healthy controls~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
198896|NCT01569568|P1|Participant Flow|Subjects With OTCD|"males and females ages 7-60 years with OTCD~MRI scanning: 1H Magnetic Resonance Spectroscopy (MRS), Diffusion Tensor Imaging (DTI), functional magnetic resonance imaging (fMRI)~Cognitive testing: Neuropsychological testing"
198897|NCT01569568|O2|Outcome|Healthy Controls|"males and females ages 7-60 years who are healthy controls~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
198898|NCT01569568|O1|Outcome|Subjects With OTCD|"males and females ages 7-60 years with OTCD~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
198899|NCT01569568|O2|Outcome|Healthy Controls|"males and females ages 7-60 years who are healthy controls~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
198900|NCT01569568|O1|Outcome|Subjects With OTCD|"males and females ages 7-60 years with OTCD~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
198901|NCT01569568|O2|Outcome|Healthy Controls|"males and females ages 7-60 years who are healthy controls~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
198902|NCT01569568|O1|Outcome|Subjects With OTCD|"males and females ages 7-60 years with OTCD~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
198903|NCT01569568|O2|Outcome|Healthy Controls|"males and females ages 7-60 years who are healthy controls~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
198904|NCT01569568|O1|Outcome|Subjects With OTCD|"males and females ages 7-60 years with OTCD~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
198905|NCT01569568|E2|Reported Event|Healthy Controls|"males and females ages 7-60 years who are healthy controls~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
198906|NCT01569568|E1|Reported Event|Subjects With OTCD|"males and females ages 7-60 years with OTCD~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
198907|NCT01569529|B3|Baseline|Total|Total of all reporting groups
198908|NCT01569529|B2|Baseline|No ad Exposure|Young adults, who registered for the cessation program, one month prior to presenting the online advertisements (intervention).
198909|NCT01569529|B1|Baseline|Ad Exposure|"Young Adults, who register for the cessation program, by clicking through the online advertisements (intervention).~Online advertisement : Internet advertisement with messages tailored for young adult smoker's motivated to quit"
198910|NCT01569529|P2|Participant Flow|No Ad Exposure|Young adults, who registered for the cessation program, after arriving at the program site though established means (e.g., search engine results), one month prior to presenting the tailored online advertisements (intervention).
198911|NCT01569529|P1|Participant Flow|Ad Exposure|"Young Adults, who register for the cessation program, by clicking through the online advertisements (intervention).~Online advertisement : Internet advertisement with messages tailored for young adult smoker's motivated to quit"
198912|NCT01569529|O2|Outcome|No ad Exposure|Young adults, who enrolled for the cessation program, one month prior to presenting the online advertisements (intervention).
198913|NCT01569529|O1|Outcome|Ad Exposure|"Young Adults, who enrolled for the cessation program, by clicking through the online advertisements (intervention).~Online advertisement : Internet advertisement with messages tailored for young adult smoker's motivated to quit"
198914|NCT01569529|E2|Reported Event|No ad Exposure|Young adults, who enrolled for the cessation program, one month prior to presenting the online advertisements (intervention).
198964|NCT01569438|O2|Outcome|Sugar Pill|Sugar Pill: Placebo
198915|NCT01569529|E1|Reported Event|Ad Exposure|"Young Adults, who enrolled for the cessation program, by clicking through the online advertisements (intervention).~Online advertisement : Internet advertisement with messages tailored for young adult smoker's motivated to quit"
198916|NCT01569464|B3|Baseline|Total|Total of all reporting groups
198917|NCT01569464|B2|Baseline|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
198918|NCT01569464|B1|Baseline|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
198919|NCT01569464|P2|Participant Flow|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
198920|NCT01569464|P1|Participant Flow|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg / 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
198921|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
198922|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
198923|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
198924|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
198925|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
198926|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
198927|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
198928|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
198929|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/r24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
198930|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
198931|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
198932|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
198933|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
198934|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
198935|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
198965|NCT01569438|O1|Outcome|Gefapixant|Gefapixant: BID
198966|NCT01569438|O2|Outcome|Sugar Pill|Sugar Pill: Placebo
198967|NCT01569438|O1|Outcome|Gefapixant|Gefapixant: BID
198968|NCT01569438|E2|Reported Event|Gefapixant|Gefapixant: BID
198969|NCT01569438|E1|Reported Event|Sugar Pill|Sugar Pill: Placebo
198936|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
198937|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
198938|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
198939|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
198940|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
198941|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
198942|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
198943|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
198944|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
198945|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
198946|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
198947|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
198948|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
198949|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/r24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
198950|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
198951|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
198952|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
198953|NCT01569464|E2|Reported Event|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
198954|NCT01569464|E1|Reported Event|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
198955|NCT01569438|B3|Baseline|Total|Total of all reporting groups
198956|NCT01569438|B2|Baseline|Sugar Pill|Sugar Pill: Placebo
198957|NCT01569438|B1|Baseline|Gefapixant|Gefapixant: BID
198958|NCT01569438|P2|Participant Flow|Gefapixant|Gefapixant: BID
198959|NCT01569438|P1|Participant Flow|Sugar Pill|Sugar Pill: Placebo
198960|NCT01569438|O2|Outcome|Sugar Pill|Sugar Pill: Placebo
198961|NCT01569438|O1|Outcome|Gefapixant|Gefapixant: BID
198971|NCT01569295|B2|Baseline|Placebo + Bendamustine + Rituximab|Placebo to match idelalisib administered orally twice daily + Rituximab 375 mg/m^2 on Day 1, then 500 mg/ m^2 every 28 days administered intravenously for a total of 6 infusions + Bendamustine 70 mg/m^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions)
198972|NCT01569295|B1|Baseline|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + Bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions)
198973|NCT01569295|P2|Participant Flow|Placebo + Bendamustine + Rituximab|Placebo to match idelalisib administered orally twice daily + Rituximab 375 mg/m^2 on Day 1, then 500 mg/ m^2 every 28 days administered intravenously for a total of 6 infusions + Bendamustine 70 mg/m^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions)
198974|NCT01569295|P1|Participant Flow|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of chronic lymphocytic leukemia (CLL), intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + Bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions)
198975|NCT01569295|O2|Outcome|Placebo + Bendamustine + Rituximab|Placebo to match idelalisib administered orally twice daily + Rituximab 375 mg/m^2 on Day 1, then 500 mg/ m^2 every 28 days administered intravenously for a total of 6 infusions + Bendamustine 70 mg/m^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions)
198976|NCT01569295|O1|Outcome|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + Bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions)
198977|NCT01569295|O2|Outcome|Placebo + Bendamustine + Rituximab|Placebo to match idelalisib administered orally twice daily + Rituximab 375 mg/m^2 on Day 1, then 500 mg/ m^2 every 28 days administered intravenously for a total of 6 infusions + Bendamustine 70 mg/m^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions)
198978|NCT01569295|O1|Outcome|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + Bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions)
198979|NCT01569295|O2|Outcome|Placebo + Bendamustine + Rituximab|Placebo to match idelalisib administered orally twice daily + Rituximab 375 mg/m^2 on Day 1, then 500 mg/ m^2 every 28 days administered intravenously for a total of 6 infusions + Bendamustine 70 mg/m^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions)
198980|NCT01569295|O1|Outcome|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + Bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions)
198981|NCT01569295|O2|Outcome|Placebo + Bendamustine + Rituximab|Placebo to match idelalisib administered orally twice daily + Rituximab 375 mg/m^2 on Day 1, then 500 mg/ m^2 every 28 days administered intravenously for a total of 6 infusions + Bendamustine 70 mg/m^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions)
198982|NCT01569295|O1|Outcome|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + Bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions)
198983|NCT01569295|O2|Outcome|Placebo + Bendamustine + Rituximab|Placebo to match idelalisib administered orally twice daily + Rituximab 375 mg/m^2 on Day 1, then 500 mg/ m^2 every 28 days administered intravenously for a total of 6 infusions + Bendamustine 70 mg/m^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions)
198984|NCT01569295|O1|Outcome|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + Bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions)
198985|NCT01569295|E2|Reported Event|Placebo + Bendamustine + Rituximab|Placebo to match idelalisib administered orally twice daily + Rituximab 375 mg/m^2 on Day 1, then 500 mg/ m^2 every 28 days administered intravenously for a total of 6 infusions + Bendamustine 70 mg/m^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions)
199013|NCT01569152|P1|Participant Flow|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199014|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199015|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
198986|NCT01569295|E1|Reported Event|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + Bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions)
198987|NCT01569191|B3|Baseline|Total|Total of all reporting groups
198988|NCT01569191|B2|Baseline|No Treatment / Artificial Tear / Cold Compress|"Exposure to grass pollen only~Preservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006 Non-Pharmaceutical Tear Supplement artificial tear~Cooled gel eye mask http://www.visiondirect.co.uk/visiondirect/ eye-gel-mask-blue Eye Gel Mask Blue placed over the closed eyes: Bag fill with temperature retention gel"
198989|NCT01569191|B1|Baseline|No Treatment / Artificial Tear / Cold Compress / Pharmaceutica|"Exposure to grass pollen only~Preservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006 Non-Pharmaceutical Tear Supplement artificial tear~Cooled gel eye mask http://www.visiondirect.co.uk/visiondirect/ eye-gel-mask-blue Eye Gel Mask Blue placed over the closed eyes: Bag fill with temperature retention gel~ELESTAT® (epinastine HCl ophthalmic solution) 0.05% Initial U.S. Approval: 2003 H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis~ELESTAT® (epinastine HCl ophthalmic solution) 0.05%: 1 drop on single occasion after exposure to grass pollen"
198990|NCT01569191|P2|Participant Flow|No Treatment / Artificial Tear / Cold Compress|"Exposure to grass pollen only~Preservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006 Non-Pharmaceutical Tear Supplement artificial tear~Cooled gel eye mask http://www.visiondirect.co.uk/visiondirect/ eye-gel-mask-blue Eye Gel Mask Blue placed over the closed eyes: Bag fill with temperature retention gel"
198991|NCT01569191|P1|Participant Flow|No Treatment/Artificial Tear / Cold Compress / Pharmaceutical|"Exposure to grass pollen only~Preservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006 Non-Pharmaceutical Tear Supplement artificial tear~Cooled gel eye mask http://www.visiondirect.co.uk/visiondirect/ eye-gel-mask-blue Eye Gel Mask Blue placed over the closed eyes: Bag fill with temperature retention gel~ELESTAT® (epinastine HCl ophthalmic solution) 0.05% Initial U.S. Approval: 2003 H1 histamine receptor antagonist"
198992|NCT01569191|O4|Outcome|Anti-allergic Medication|"ELESTAT® (epinastine HCl ophthalmic solution) 0.05% Initial U.S. Approval: 2003 H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis~ELESTAT® (epinastine HCl ophthalmic solution) 0.05%: 1 drop on single occasion after exposure to grass pollen"
198993|NCT01569191|O3|Outcome|Cold Compress|"Cooled gel eye mask http://www.visiondirect.co.uk/vision-direct/eye-gel-mask-blue~Eye Gel Mask Blue placed over the closed eyes: Bag fill with temperature retention gel"
198994|NCT01569191|O2|Outcome|Artificial Tear Supplement|"Preservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006~Non-Pharmaceutical Tear Supplement: artificial tear supplement (Hypromellose)"
198995|NCT01569191|O1|Outcome|No Treatment|Exposure to grass pollen only
198996|NCT01569191|O4|Outcome|Anti-allergic Medication|"ELESTAT® (epinastine HCl ophthalmic solution) 0.05% Initial U.S. Approval: 2003 H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis~ELESTAT® (epinastine HCl ophthalmic solution) 0.05%: 1 drop on single occasion after exposure to grass pollen"
198997|NCT01569191|O3|Outcome|Cold Compress|"Cooled gel eye mask http://www.visiondirect.co.uk/vision-direct/eye-gel-mask-blue~Eye Gel Mask Blue placed over the closed eyes: Bag fill with temperature retention gel"
198998|NCT01569191|O2|Outcome|Artificial Tear Supplement|"Preservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006~Non-Pharmaceutical Tear Supplement: artificial tear supplement (Hypromellose)"
198999|NCT01569191|O1|Outcome|No Treatment|Exposure to grass pollen only
199000|NCT01569191|O4|Outcome|Anti-allergic Medication|"ELESTAT® (epinastine HCl ophthalmic solution) 0.05% Initial U.S. Approval: 2003 H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis~ELESTAT® (epinastine HCl ophthalmic solution) 0.05%: 1 drop on single occasion after exposure to grass pollen"
199001|NCT01569191|O3|Outcome|Cold Compress|"Cooled gel eye mask http://www.visiondirect.co.uk/vision-direct/eye-gel-mask-blue~Eye Gel Mask Blue placed over the closed eyes: Bag fill with temperature retention gel"
199002|NCT01569191|O2|Outcome|Artificial Tear Supplement|"Preservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006~Non-Pharmaceutical Tear Supplement: artificial tear supplement (Hypromellose)"
199003|NCT01569191|O1|Outcome|No Treatment|Exposure to grass pollen only
199004|NCT01569191|E4|Reported Event|Anti-allergic Medication|"ELESTAT® (epinastine HCl ophthalmic solution) 0.05% Initial U.S. Approval: 2003 H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis~ELESTAT® (epinastine HCl ophthalmic solution) 0.05%: 1 drop on single occasion after exposure to grass pollen"
199005|NCT01569191|E3|Reported Event|Cold Compress|"Cooled gel eye mask http://www.visiondirect.co.uk/vision-direct/eye-gel-mask-blue~Eye Gel Mask Blue placed over the closed eyes: Bag fill with temperature retention gel"
199006|NCT01569191|E2|Reported Event|Artificial Tear Supplement|"Preservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006~Non-Pharmaceutical Tear Supplement: artificial tear supplement (Hypromellose)"
199007|NCT01569191|E1|Reported Event|No Treatment|Exposure to grass pollen only
199008|NCT01569152|B3|Baseline|Total|Total of all reporting groups
199009|NCT01569152|B2|Baseline|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199010|NCT01569152|B1|Baseline|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199011|NCT01569152|P3|Participant Flow|Safety Extension Period 3: MK-8457|MK-8457 100 mg BID + MTX for up to approximately 52 weeks in Safety Extension Period 3. Participants who completed or had early escape from Base Study Phase IIa were eligible to enroll in Safety Extension Period 3.
199012|NCT01569152|P2|Participant Flow|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199818|NCT01566773|O5|Outcome|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
199016|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199017|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199018|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199019|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199020|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199021|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199022|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199023|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199024|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199025|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199026|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199027|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199028|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199029|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199030|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199031|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199032|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199033|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199034|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199035|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199036|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199037|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199038|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199039|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199040|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199041|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199042|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199043|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199044|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199045|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199046|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199047|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199048|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199049|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199050|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199051|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199052|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199053|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199054|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199055|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199056|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199057|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199058|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199059|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199060|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199061|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199062|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199063|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199064|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199065|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199066|NCT01569152|E3|Reported Event|Safety Extension Period 3: MK-8457|MK-8457 100 mg BID + MTX for up to approximately 52 weeks in Safety Extension Period 3. Participants who completed or had early escape from Base Study Phase IIa were eligible to enroll in Safety Extension Period 3.
199067|NCT01569152|E2|Reported Event|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
199068|NCT01569152|E1|Reported Event|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
199069|NCT01569126|B7|Baseline|Total|Total of all reporting groups
199070|NCT01569126|B6|Baseline|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
199071|NCT01569126|B5|Baseline|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
199072|NCT01569126|B4|Baseline|Placebo (MD)|Participants, in Cohorts 4 and 5, who received a placebo capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28 participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
199073|NCT01569126|B3|Baseline|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
199074|NCT01569126|B2|Baseline|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
199075|NCT01569126|B1|Baseline|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
199076|NCT01569126|P6|Participant Flow|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
199077|NCT01569126|P5|Participant Flow|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
199078|NCT01569126|P4|Participant Flow|Placebo (MD)|Participants, in Cohorts 4 and 5, who received a placebo capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28 participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
199079|NCT01569126|P3|Participant Flow|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
199080|NCT01569126|P2|Participant Flow|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
199081|NCT01569126|P1|Participant Flow|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
199082|NCT01569126|O6|Outcome|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
199083|NCT01569126|O5|Outcome|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
199084|NCT01569126|O4|Outcome|Placebo (MD)|Participants, in Cohorts 4 and 5, who received a placebo capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
199085|NCT01569126|O3|Outcome|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
199086|NCT01569126|O2|Outcome|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
199087|NCT01569126|O1|Outcome|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
199088|NCT01569126|O2|Outcome|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
199089|NCT01569126|O1|Outcome|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
199090|NCT01569126|O2|Outcome|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
199091|NCT01569126|O1|Outcome|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
199092|NCT01569126|O2|Outcome|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
199093|NCT01569126|O1|Outcome|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
199094|NCT01569126|O3|Outcome|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
199095|NCT01569126|O2|Outcome|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
199096|NCT01569126|O1|Outcome|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
199097|NCT01569126|O3|Outcome|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
199098|NCT01569126|O2|Outcome|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
199099|NCT01569126|O1|Outcome|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
199100|NCT01569126|O3|Outcome|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
199101|NCT01569126|O2|Outcome|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
199102|NCT01569126|O1|Outcome|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
199103|NCT01569126|O3|Outcome|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
199104|NCT01569126|O2|Outcome|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
199105|NCT01569126|O1|Outcome|Placebo (MD)|Participants, in Cohorts 4 and 5, who received a placebo capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
199106|NCT01569126|O3|Outcome|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
199107|NCT01569126|O2|Outcome|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
199108|NCT01569126|O1|Outcome|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
199109|NCT01569126|E6|Reported Event|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28 participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
199110|NCT01569126|E5|Reported Event|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28 participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
199111|NCT01569126|E4|Reported Event|Placebo (MD)|Participants, in Cohorts 4 and 5, who received a placebo capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28 participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
199112|NCT01569126|E3|Reported Event|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
199113|NCT01569126|E2|Reported Event|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
199114|NCT01569126|E1|Reported Event|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
199115|NCT01569087|B4|Baseline|Total|Total of all reporting groups
199116|NCT01569087|B3|Baseline|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
199117|NCT01569087|B2|Baseline|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
199118|NCT01569087|B1|Baseline|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
199119|NCT01569087|P3|Participant Flow|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
199120|NCT01569087|P2|Participant Flow|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
199121|NCT01569087|P1|Participant Flow|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
199122|NCT01569087|O3|Outcome|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
199212|NCT01569022|O1|Outcome|CPAP|"CPAP treatment for sleep apnea~CPAP: CPAP Treatment for 12 weeks"
199213|NCT01569022|O2|Outcome|Mandibular Advancing Device|Mandibular advancing device treatment for 12 weeks
199123|NCT01569087|O2|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
199124|NCT01569087|O1|Outcome|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
199125|NCT01569087|O3|Outcome|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
199126|NCT01569087|O2|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
199127|NCT01569087|O1|Outcome|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
199128|NCT01569087|O3|Outcome|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
199129|NCT01569087|O2|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
199130|NCT01569087|O1|Outcome|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
199131|NCT01569087|O3|Outcome|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
199132|NCT01569087|O2|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
199133|NCT01569087|O1|Outcome|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
199134|NCT01569087|O3|Outcome|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
199135|NCT01569087|O2|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
199136|NCT01569087|O1|Outcome|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
199137|NCT01569087|O3|Outcome|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
199138|NCT01569087|O2|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
199139|NCT01569087|O1|Outcome|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
199140|NCT01569087|E3|Reported Event|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
199141|NCT01569087|E2|Reported Event|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
199214|NCT01569022|O1|Outcome|CPAP|CPAP treatment for 12 weeks
199142|NCT01569087|E1|Reported Event|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
199143|NCT01569074|B6|Baseline|Total|Total of all reporting groups
199144|NCT01569074|B5|Baseline|PLACEBO PO|Dosing Group E
199145|NCT01569074|B4|Baseline|FOSTA 50 MG BID PO|Dosing Group D
199146|NCT01569074|B3|Baseline|FOSTA 75 MG BID PO|Dosing Group C
199147|NCT01569074|B2|Baseline|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
199148|NCT01569074|B1|Baseline|FOSTA 100 MG BID PO|Dosing Group A
199149|NCT01569074|P5|Participant Flow|PLACEBO PO|Dosing Group E
199150|NCT01569074|P4|Participant Flow|FOSTA 50 MG BID PO|Dosing Group D
199151|NCT01569074|P3|Participant Flow|FOSTA 75 MG BID PO|Dosing Group C
199152|NCT01569074|P2|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
199153|NCT01569074|P1|Participant Flow|FOSTA 100 MG BID PO|Dosing Group A
199154|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
199155|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
199156|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
199157|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
199158|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
199159|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
199160|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
199161|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
199162|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
199163|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
199164|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
199165|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
199166|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
199167|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
199168|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
199169|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
199170|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
199171|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
199172|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
199173|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
199174|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
199175|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
199176|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
199177|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
199178|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
199179|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
199180|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
199181|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
199182|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
199183|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
199184|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
199185|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
199186|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
199187|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
199188|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
199189|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
199190|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
199191|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
199192|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
199193|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
199194|NCT01569074|O4|Outcome|FOSTA 100 MG BID PO|Dosing Group A
199195|NCT01569074|O3|Outcome|PLACEBO PO|Dosing Group E
199196|NCT01569074|O2|Outcome|FOSTA 50 MG BID PO|Dosing Group D
199197|NCT01569074|O1|Outcome|FOSTA 75 MG BID PO|Dosing Group C
199198|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
199199|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
199200|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
199201|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
199202|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
199203|NCT01569074|E5|Reported Event|PLACEBO PO|Dosing Group E
199204|NCT01569074|E4|Reported Event|FOSTA 75 MG BID PO|Dosing Group C
199205|NCT01569074|E3|Reported Event|FOSTA 50 MG BID PO|Dosing Group D
199206|NCT01569074|E2|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
199207|NCT01569074|E1|Reported Event|FOSTA 100 MG BID PO|Dosing Group A
199208|NCT01569022|B1|Baseline|All Study Participants|"Participants were asked to acclimate to CPAP and MAD for 4 weeks (total) during which adjustments to both modes of therapy are made aiming to optimize comfort and abolish snoring.~If the interface was found to be uncomfortable, the patient was given the opportunity to change the mask. None of the participants was exposed to dual therapy or had access to both devices at the same time. Weekly phone calls were made to inquire about side effects or problems with CPAP or MAD. At the end of the acclimatization period, patients underwent a 2-week washout, after which they were randomly assigned in 1:1 ratio via a presealed and numbered opaque white envelope to one of the two treatment modalities (CPAP or MAD) that included the assignment to receive 12 weeks of treatment with MAD and CPAP in alternating order"
199209|NCT01569022|P2|Participant Flow|MAD First, CPAP|"MAD treatment for sleep apnea~MAD: MAD Treatment for 12 weeks CPAP: CPAP treatment for 12 weeks"
199210|NCT01569022|P1|Participant Flow|CPAP First, MAD|"CPAP treatment for sleep apnea~CPAP: CPAP Treatment for 12 weeks MAD: MAD treatment for 12 weeks"
199211|NCT01569022|O2|Outcome|Mandibular Advancing Device|"MAD treatment for sleep apnea~MAD: MAD Treatment for 12 weeks"
199819|NCT01566773|O4|Outcome|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
199215|NCT01569022|O2|Outcome|Mandibular Advancing Device|Mandibular advancing device treatment for 12 weeks
199216|NCT01569022|O1|Outcome|CPAP|CPAP treatment for 12 weeks
199217|NCT01569022|O2|Outcome|Mandibular Advancing Device|"MAD treatment for sleep apnea~MAD: MAD Treatment for 12 weeks"
199218|NCT01569022|O1|Outcome|CPAP|"CPAP treatment for sleep apnea~CPAP: CPAP Treatment for 12 weeks"
199219|NCT01569022|E2|Reported Event|Mandibular Advancing Device|"MAD treatment for sleep apnea~MAD: MAD Treatment for 12 weeks"
199220|NCT01569022|E1|Reported Event|CPAP|"CPAP treatment for sleep apnea~CPAP: CPAP Treatment for 12 weeks"
199221|NCT01568905|B4|Baseline|Total|Total of all reporting groups
199222|NCT01568905|B3|Baseline|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette (10.4 mg/g; menthol: 12.3): smoke the study cigarette exclusively for one week
199223|NCT01568905|B2|Baseline|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette (5.86 mg/g menthol 5.87 mg/g): smoke the study cigarette exclusively for one week
199224|NCT01568905|B1|Baseline|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette (0.400 mg/g; menthol 0.405 mg/g): smoke the study cigarette exclusively for one week
199225|NCT01568905|P3|Participant Flow|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
199226|NCT01568905|P2|Participant Flow|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
199227|NCT01568905|P1|Participant Flow|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
199228|NCT01568905|O3|Outcome|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
199229|NCT01568905|O2|Outcome|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
199230|NCT01568905|O1|Outcome|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
199231|NCT01568905|O3|Outcome|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
199232|NCT01568905|O2|Outcome|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
199233|NCT01568905|O1|Outcome|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
199234|NCT01568905|O3|Outcome|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
199235|NCT01568905|O2|Outcome|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
199236|NCT01568905|O1|Outcome|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
199237|NCT01568905|O3|Outcome|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
199238|NCT01568905|O2|Outcome|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
199239|NCT01568905|O1|Outcome|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
199240|NCT01568905|E3|Reported Event|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
199241|NCT01568905|E2|Reported Event|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
199242|NCT01568905|E1|Reported Event|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
199243|NCT01568892|B3|Baseline|Total|Total of all reporting groups
199244|NCT01568892|B2|Baseline|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199245|NCT01568892|B1|Baseline|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199246|NCT01568892|P2|Participant Flow|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199247|NCT01568892|P1|Participant Flow|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199248|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199249|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199250|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199320|NCT01568593|O1|Outcome|T2750|T2750: 1 drop in each eye 3 to 6 times daily during 84 days
199251|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199252|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199253|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199254|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199255|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199256|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199257|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199258|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199259|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199260|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199261|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199262|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199263|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199264|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199265|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199266|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199267|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199268|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199321|NCT01568593|E2|Reported Event|Vismed|Vismed: 1 drop in each eye 3 to 6 times daily during 84 days
199322|NCT01568593|E1|Reported Event|T2750|T2750: 1 drop in each eye 3 to 6 times daily during 84 days
199820|NCT01566773|O3|Outcome|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
199269|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199270|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199271|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199272|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199273|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199274|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199275|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199276|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199277|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199278|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199279|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199280|NCT01568892|E2|Reported Event|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199281|NCT01568892|E1|Reported Event|DTG 50mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
199282|NCT01568866|B3|Baseline|Total|Total of all reporting groups
199283|NCT01568866|B2|Baseline|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
199284|NCT01568866|B1|Baseline|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
199285|NCT01568866|P2|Participant Flow|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
199286|NCT01568866|P1|Participant Flow|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
199287|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
199288|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
199385|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199289|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
199290|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
199291|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
199292|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
199293|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
199294|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
199295|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
199296|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
199297|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
199298|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
199299|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
199300|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
199301|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
199302|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
199303|NCT01568866|E2|Reported Event|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
199304|NCT01568866|E1|Reported Event|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
199305|NCT01568827|B3|Baseline|Total|Total of all reporting groups
199306|NCT01568827|B2|Baseline|No Intervention|Water without lypholized black raspberry powder
199307|NCT01568827|B1|Baseline|Black-raspberry Powder|Black-raspberry powder: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries
199308|NCT01568827|P2|Participant Flow|Blackraspberry Slurry First, Then Washout, Then Water|Blackraspberry slurry daily x 5 days, 2 day washout, 8 oz. water daily x 5 days
199309|NCT01568827|P1|Participant Flow|Water First, Then Washout, Then Blackraspberry Slurry|8 oz. water daily x 5 days, 2 day washout, Blackraspberry slurry daily x 5 days
199310|NCT01568827|O2|Outcome|Blackraspberry Slurry|Blackraspberry slurry: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries mixed with 8 oz water
199311|NCT01568827|O1|Outcome|Water|Water without lypholized black raspberry powder
199312|NCT01568827|E2|Reported Event|Water, Washout, Black-raspberry Slurry|Black-raspberry Slurry: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries.
199313|NCT01568827|E1|Reported Event|Black-raspberry Slurry, Washout, Water|Black-raspberry Slurry: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries.
199314|NCT01568593|B3|Baseline|Total|Total of all reporting groups
199315|NCT01568593|B2|Baseline|Vismed|Vismed: 1 drop in each eye 3 to 6 times daily during 84 days
199316|NCT01568593|B1|Baseline|T2750|T2750: 1 drop in each eye 3 to 6 times daily during 84 days
199317|NCT01568593|P2|Participant Flow|Vismed|Vismed: 1 drop in each eye 3 to 6 times daily during 84 days
199318|NCT01568593|P1|Participant Flow|T2750|T2750: 1 drop in each eye 3 to 6 times daily during 84 days
199319|NCT01568593|O2|Outcome|Vismed|Vismed: 1 drop in each eye 3 to 6 times daily during 84 days
199821|NCT01566773|O2|Outcome|GP MDI 9 µg BID|GP MDI 9 µg BID.
199323|NCT01568424|B1|Baseline|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.~CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
199324|NCT01568424|P1|Participant Flow|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.~CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
199325|NCT01568424|O1|Outcome|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.~CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
199326|NCT01568424|O1|Outcome|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.~CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
199327|NCT01568424|O1|Outcome|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.~CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
199328|NCT01568424|O1|Outcome|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.~CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
199329|NCT01568424|O1|Outcome|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.~CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
199330|NCT01568424|O1|Outcome|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.~CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
199331|NCT01568424|O1|Outcome|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.~CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
199332|NCT01568424|E1|Reported Event|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.~CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
199333|NCT01568112|B5|Baseline|Total|Total of all reporting groups
199334|NCT01568112|B4|Baseline|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg once daily [QD] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199335|NCT01568112|B3|Baseline|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199336|NCT01568112|B2|Baseline|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199337|NCT01568112|B1|Baseline|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199338|NCT01568112|P4|Participant Flow|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg once daily [QD] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199339|NCT01568112|P3|Participant Flow|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199340|NCT01568112|P2|Participant Flow|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199341|NCT01568112|P1|Participant Flow|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199342|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199343|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199344|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199345|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199346|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199347|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199348|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199349|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199350|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199351|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199352|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199353|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199417|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199354|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199355|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199356|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199357|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199358|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199359|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199360|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199361|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199362|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199363|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199364|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199365|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199366|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199367|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199368|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199369|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199370|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199371|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199372|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199373|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199374|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199375|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199376|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199377|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199378|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199379|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199380|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199381|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199382|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199383|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199384|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199603|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|aggressive lipid therapy: Crestor
199386|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199387|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199388|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199389|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199390|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199391|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199392|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199393|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199394|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199395|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199396|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199397|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199398|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199399|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199400|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199401|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199402|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199403|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199404|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199405|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199406|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199407|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199408|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199409|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199410|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199411|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199412|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199413|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199414|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199415|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199416|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199775|NCT01566773|O1|Outcome|GP MDI 18 µg BID|GP MDI 18 µg BID.
199418|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199419|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199420|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199421|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199422|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199423|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199424|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199425|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199426|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199427|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199428|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199429|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199430|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199431|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199432|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199433|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199434|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199435|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199436|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199437|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199438|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199439|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199440|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199441|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199442|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199443|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199444|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199445|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199446|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199447|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199448|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199776|NCT01566773|O8|Outcome|Spiriva® Handihaler®|Spiriva® Handihaler® (Tiotropium Bromide).
199449|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199450|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg once daily [QD] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199451|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199452|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199453|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199454|NCT01568112|E4|Reported Event|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg once daily [QD] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
199455|NCT01568112|E3|Reported Event|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
199456|NCT01568112|E2|Reported Event|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
199457|NCT01568112|E1|Reported Event|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
199458|NCT01568073|B6|Baseline|Total|Total of all reporting groups
199459|NCT01568073|B5|Baseline|OPC 50mg|OPC, Opicapone 50mg
199460|NCT01568073|B4|Baseline|OPC 25mg|OPC, Opicapone 25mg
199461|NCT01568073|B3|Baseline|OPC 5mg|OPC, Opicapone 5mg
199462|NCT01568073|B2|Baseline|Entacapone|Entacapone - 200 mg
199463|NCT01568073|B1|Baseline|Placebo|Placebo 200 mg
199464|NCT01568073|P5|Participant Flow|OPC 50mg|OPC, Opicapone 50mg
199465|NCT01568073|P4|Participant Flow|OPC 25mg|OPC, Opicapone 25mg
199466|NCT01568073|P3|Participant Flow|OPC 5mg|OPC, Opicapone 5mg
199467|NCT01568073|P2|Participant Flow|Entacapone|Entacapone - 200 mg
199468|NCT01568073|P1|Participant Flow|Placebo|Placebo 200 mg
199469|NCT01568073|O5|Outcome|OPC 50mg|OPC, Opicapone 50mg
199470|NCT01568073|O4|Outcome|OPC 25mg|OPC, Opicapone 25mg
199471|NCT01568073|O3|Outcome|OPC 5mg|OPC, Opicapone 5mg
199472|NCT01568073|O2|Outcome|Entacapone|Entacapone - 200 mg
199473|NCT01568073|O1|Outcome|Placebo|Placebo 200 mg
199474|NCT01568073|O5|Outcome|OPC 50mg|OPC, Opicapone 50mg
199475|NCT01568073|O4|Outcome|OPC 25mg|OPC, Opicapone 25mg
199476|NCT01568073|O3|Outcome|OPC 5mg|OPC, Opicapone 5mg
199477|NCT01568073|O2|Outcome|Entacapone|Entacapone - 200 mg
199478|NCT01568073|O1|Outcome|Placebo|Placebo 200 mg
199479|NCT01568073|O5|Outcome|OPC 50mg|OPC, Opicapone 50mg
199480|NCT01568073|O4|Outcome|OPC 25mg|OPC, Opicapone 25mg
199481|NCT01568073|O3|Outcome|OPC 5mg|OPC, Opicapone 5mg
199482|NCT01568073|O2|Outcome|Entacapone|Entacapone - 200 mg
199483|NCT01568073|O1|Outcome|Placebo|Placebo 200 mg
199484|NCT01568073|O5|Outcome|OPC 50mg|OPC, Opicapone 50mg
199485|NCT01568073|O4|Outcome|OPC 25mg|OPC, Opicapone 25mg
199486|NCT01568073|O3|Outcome|OPC 5mg|OPC, Opicapone 5mg
199487|NCT01568073|O2|Outcome|Entacapone|Entacapone - 200 mg
199488|NCT01568073|O1|Outcome|Placebo|Placebo 200 mg
199489|NCT01568073|E5|Reported Event|OPC 50mg|OPC, Opicapone 50mg
199490|NCT01568073|E4|Reported Event|OPC 25mg|OPC, Opicapone 25mg
199491|NCT01568073|E3|Reported Event|OPC 5mg|OPC, Opicapone 5mg
199492|NCT01568073|E2|Reported Event|Entacapone|Entacapone - 200 mg
199493|NCT01568073|E1|Reported Event|Placebo|Placebo 200 mg
199494|NCT01568047|B5|Baseline|Total|Total of all reporting groups
199495|NCT01568047|B4|Baseline|BIA 9-1067 (30 mg)|30 mg BIA 9-1067 - OPC, Opicapone
199496|NCT01568047|B3|Baseline|BIA 9-1067 (15 mg)|15 mg BIA 9-1067 - OPC, Opicapone
199497|NCT01568047|B2|Baseline|BIA 9-1067 (5 mg)|5 mg BIA 9-1067 - OPC, Opicapone
199498|NCT01568047|B1|Baseline|Placebo|PLC, Placebo
199499|NCT01568047|P4|Participant Flow|BIA 9-1067 (30 mg)|OPC, Opicapone
199500|NCT01568047|P3|Participant Flow|BIA 9-1067 (15 mg)|OPC, Opicapone
199501|NCT01568047|P2|Participant Flow|BIA 9-1067 (5 mg)|OPC, Opicapone
199502|NCT01568047|P1|Participant Flow|Placebo|PLC, Placebo
199503|NCT01568047|O4|Outcome|BIA 9-1067 30 mg|30 mg BIA 9-1067 - OPC, Opicapone
199504|NCT01568047|O3|Outcome|BIA 9-1067 15 mg|15 mg BIA 9-1067 - OPC, Opicapone
199505|NCT01568047|O2|Outcome|BIA 9-1067 5 mg|5 mg BIA 9-1067 - OPC, Opicapone
199506|NCT01568047|O1|Outcome|Placebo|PLC, Placebo
199507|NCT01568047|O4|Outcome|BIA 9-1067 30 mg|30 mg BIA 9-1067 - OPC, Opicapone
199508|NCT01568047|O3|Outcome|BIA 9-1067 15 mg|15 mg BIA 9-1067 - OPC, Opicapone
199509|NCT01568047|O2|Outcome|BIA 9-1067 5 mg|5 mg BIA 9-1067 - OPC, Opicapone
199510|NCT01568047|O1|Outcome|Placebo|PLC, Placebo
199511|NCT01568047|O4|Outcome|BIA 9-1067 30 mg|30 mg BIA 9-1067 - OPC, Opicapone
199512|NCT01568047|O3|Outcome|BIA 9-1067 15 mg|15 mg BIA 9-1067 - OPC, Opicapone
199513|NCT01568047|O2|Outcome|BIA 9-1067 5 mg|5 mg BIA 9-1067 - OPC, Opicapone
199514|NCT01568047|O1|Outcome|Placebo|PLC, Placebo
199515|NCT01568047|E4|Reported Event|BIA 9-1067 (30 mg)|30 mg BIA 9-1067, OPC, Opicapone
199516|NCT01568047|E3|Reported Event|BIA 9-1067 (15 mg)|15 mg BIA 9-1067, OPC, Opicapone
199517|NCT01568047|E2|Reported Event|BIA 9-1067 (5 mg)|5 mg BIA 9-1067, OPC, Opicapone
199518|NCT01568047|E1|Reported Event|Placebo|Placebo, PLC
199777|NCT01566773|O7|Outcome|Placebo MDI|Placebo MDI.
199519|NCT01568034|B1|Baseline|Overall Study|The study was to consist of four consecutive treatment periods, corresponding to the 4 different treatment options (25 mg, 50 mg and 100 mg BIA 9-1067or Placebo).According to randomisation, subjects were to receive, in a double-blind manner, 25, 50 and 100 mg BIA 9-1067 or Placebo at 4 separate treatment periods. Each subject were to receive each of the three BIA 9-1067 doses and Placebo in a random sequence with a 3:1 ratio (BIA 9-1067: Placebo) per treatment period.
199520|NCT01568034|P4|Participant Flow|Treatment Sequence D|"Treatment Sequence D Period 1 - 50 mg BIA 9-1067 Period 2 - 100 mg BIA 9-1067 Period 3 - Placebo Period 4 - 25 mg BIA 9-1067~Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half"
199521|NCT01568034|P3|Participant Flow|Treatment Sequence C|"Treatment Sequence C Period 1 - 100 mg BIA 9-1067 Period 2 - Placebo Period 3 - 25 mg BIA 9-1067 Period 4 - 50 mg BIA 9-1067~Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half"
199522|NCT01568034|P2|Participant Flow|Treatment Sequence B|"Treatment Sequence B Period 1 - Placebo Period 2 - 25 mg BIA 9-1067 Period 3 - 50 mg BIA 9-1067 Period 4 - 100 mg BIA 9-1067~Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half"
199523|NCT01568034|P1|Participant Flow|Treatment Sequence A|"Period 1 - 25 mg BIA 9-1067 Period 2 - 50 mg BIA 9-1067 Period 3 - 100 mg BIA 9-1067 Period 4 - Placebo~Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half"
199524|NCT01568034|O4|Outcome|BIA 9-1067 100 mg|BIA 9-1067 - OPC, Opicapone
199525|NCT01568034|O3|Outcome|BIA 9-1067 50 mg|BIA 9-1067 - OPC, Opicapone
199526|NCT01568034|O2|Outcome|BIA 9-1067 25 mg|BIA 9-1067 - OPC, Opicapone
199527|NCT01568034|O1|Outcome|Placebo|PLC, Placebo
199528|NCT01568034|O4|Outcome|BIA 9-1067 100 mg|BIA 9-1067 - OPC, Opicapone
199529|NCT01568034|O3|Outcome|BIA 9-1067 50 mg|BIA 9-1067 - OPC, Opicapone
199530|NCT01568034|O2|Outcome|BIA 9-1067 25 mg|BIA 9-1067 - OPC, Opicapone
199531|NCT01568034|O1|Outcome|Placebo|PLC, Placebo
199532|NCT01568034|O4|Outcome|BIA 9-1067 100 mg|BIA 9-1067 - OPC, Opicapone
199533|NCT01568034|O3|Outcome|BIA 9-1067 50 mg|BIA 9-1067 - OPC, Opicapone
199534|NCT01568034|O2|Outcome|BIA 9-1067 25 mg|BIA 9-1067 - OPC, Opicapone
199535|NCT01568034|O1|Outcome|Placebo|PLC, Placebo
199536|NCT01568034|E4|Reported Event|Placebo|Placebo ESL, Eslicarbazepine
199537|NCT01568034|E3|Reported Event|100 mg BIA 9-1067|100 mg BIA 9-1067 ESL, Eslicarbazepine
199538|NCT01568034|E2|Reported Event|50 mg BIA 9-1067|50 mg BIA 9-1067 ESL, Eslicarbazepine
199539|NCT01568034|E1|Reported Event|25 mg BIA 9-1067|25 mg BIA 9-1067 ESL, Eslicarbazepine
199540|NCT01568021|B1|Baseline|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
199541|NCT01568021|P1|Participant Flow|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
199542|NCT01568021|O1|Outcome|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
199543|NCT01568021|O1|Outcome|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
199544|NCT01568021|O1|Outcome|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
199545|NCT01568021|E1|Reported Event|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
199546|NCT01568008|B1|Baseline|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
199547|NCT01568008|P1|Participant Flow|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
199548|NCT01568008|O1|Outcome|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
199549|NCT01568008|O1|Outcome|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
199550|NCT01568008|O1|Outcome|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
199551|NCT01568008|O1|Outcome|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
199552|NCT01568008|O1|Outcome|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
199553|NCT01568008|O1|Outcome|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
199554|NCT01568008|E1|Reported Event|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
199555|NCT01567943|B3|Baseline|Total|Total of all reporting groups
199556|NCT01567943|B2|Baseline|Non-contingent Control Group|Treatment as usual plus reinforcement for attendance
199557|NCT01567943|B1|Baseline|Contingency Management|"Contingency Management plus treatment as usual~Contingency Management: Behavioral reinforcement for alcohol abstinence"
199558|NCT01567943|P3|Participant Flow|Pre-randomization Drop-out|These participants were enrolled/consented in the study but not randomized to the Contingency Management or Control conditions.
199559|NCT01567943|P2|Participant Flow|Non-contingent Control Group|Treatment as usual plus reinforcement for attendance
199560|NCT01567943|P1|Participant Flow|Contingency Management|"Contingency Management plus treatment as usual~Contingency Management: Behavioral reinforcement for alcohol abstinence"
199561|NCT01567943|O2|Outcome|Non-contingent Control Group|Treatment as usual plus reinforcement for attendance
199778|NCT01566773|O6|Outcome|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
199562|NCT01567943|O1|Outcome|Contingency Management|"Contingency Management plus treatment as usual~Contingency Management: Behavioral reinforcement for alcohol abstinence"
199563|NCT01567943|O2|Outcome|Non-contingent Control Group|Treatment as usual plus reinforcement for attendance
199564|NCT01567943|O1|Outcome|Contingency Management|"Contingency Management plus treatment as usual~Contingency Management: Behavioral reinforcement for alcohol abstinence"
199565|NCT01567943|E2|Reported Event|Non-contingent Control Group|Treatment as usual plus reinforcement for attendance
199566|NCT01567943|E1|Reported Event|Contingency Management|"Contingency Management plus treatment as usual~Contingency Management: Behavioral reinforcement for alcohol abstinence"
199567|NCT01567852|B3|Baseline|Total|Total of all reporting groups
199568|NCT01567852|B2|Baseline|Methohexital First|"This arm will receive Methohexital first for induction, followed by alternating treatments between ketamine and methohexital.~Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect~Methohexital: Methohexital (1-1.5mg/kg) will be given for induction"
199569|NCT01567852|B1|Baseline|Ketamine First|"This arm will receive ketamine for induction first, followed by alternating treatments between methohexital and ketamine~Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect~Methohexital: Methohexital (1-1.5mg/kg) will be given for induction"
199570|NCT01567852|P2|Participant Flow|Methohexital Then Ketamine (Alternating Each Trial)|"This arm will receive Methohexital first for induction, followed by alternating treatments between ketamine and methohexital. Each induction is one trial. Each trial is followed by one day of no treatment (2 days for weekends).~Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect~Methohexital: Methohexital (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect"
199571|NCT01567852|P1|Participant Flow|Ketamine Then Methohexital (Alternating Each Trial)|"This arm will receive ketamine for induction first, followed by alternating treatments between methohexital and ketamine. Each induction is counted as one trial. Each trial is followed by a day of no treatment (2 days for weekends).~Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect~Methohexital: Methohexital (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect"
199572|NCT01567852|O2|Outcome|Methohexital Inductions|Patients receiving methohexital for inductions
199573|NCT01567852|O1|Outcome|Ketamine Inductions|Patients receiving Ketamine inductions for ECT
199574|NCT01567852|O2|Outcome|Methohexital Inductions|Patients receiving methohexital for inductions
199575|NCT01567852|O1|Outcome|Ketamine Inductions|Patients receiving Ketamine inductions for ECT
199576|NCT01567852|E2|Reported Event|Methohexital Inductions|Number of trials receiving methohexital inductions. Each trial is one induction
199577|NCT01567852|E1|Reported Event|Ketamine Inductions|Number of trials receiving ketamine inductions. Each trial is one induction.
199578|NCT01567839|B1|Baseline|Subjects Receiving Injections|All subjects received each of the three anesthetic injections.
199579|NCT01567839|P1|Participant Flow|Subjects Receiving Injections|All subjects received each of the three anesthetic injections.
199580|NCT01567839|O3|Outcome|4% Prilocaine With 1:200,000 Epinephrine|
199581|NCT01567839|O2|Outcome|4% Lidocaine With 1:100,000 Epinephrine|
199582|NCT01567839|O1|Outcome|4% Articaine With 1:100,000 Epinephrine|
199583|NCT01567839|E3|Reported Event|4% Prilocaine With 1:200,000 Epinephrine|
199584|NCT01567839|E2|Reported Event|4% Lidocaine With 1:100,000 Epinephrine|
199585|NCT01567839|E1|Reported Event|4% Articaine With 1:100,000 Epinephrine|
199586|NCT01567826|B3|Baseline|Total|Total of all reporting groups
199587|NCT01567826|B2|Baseline|Aggressive Lipid Therapy|"aggressive lipid therapy: Crestor~Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy."
199588|NCT01567826|B1|Baseline|Standard of Care Lipid Therapy|"standard-care lipid-lowering therapy: Zocor or Lipitor~standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.~Zocor, Lipitor [any dose] and Crestor [less than 40mg]"
199589|NCT01567826|P2|Participant Flow|Aggressive Lipid Therapy|"aggressive lipid therapy: Crestor~Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy."
199590|NCT01567826|P1|Participant Flow|Standard of Care Lipid Therapy|"standard-care lipid-lowering therapy: Zocor or Lipitor~standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.~Zocor, Lipitor [any dose] and Crestor [less than 40mg]"
199591|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|aggressive lipid therapy: Crestor
199592|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|standard-care lipid-lowering therapy: Zocor or Lipitor
199593|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|aggressive lipid therapy: Crestor
199594|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|standard-care lipid-lowering therapy: Zocor or Lipitor
199595|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|aggressive lipid therapy: Crestor
199596|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|standard-care lipid-lowering therapy: Zocor or Lipitor
199597|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|aggressive lipid therapy: Crestor
199598|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|standard-care lipid-lowering therapy: Zocor or Lipitor
199599|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|aggressive lipid therapy: Crestor
199600|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|standard-care lipid-lowering therapy: Zocor or Lipitor
199601|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|"aggressive lipid therapy: Crestor~Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy."
199602|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|"standard-care lipid-lowering therapy: Zocor or Lipitor~standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.~Zocor, Lipitor [any dose] and Crestor [less than 40mg]"
199604|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|standard-care lipid-lowering therapy: Zocor or Lipitor
199605|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|aggressive lipid therapy: Crestor
199606|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|standard-care lipid-lowering therapy: Zocor or Lipitor
199607|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|"aggressive lipid therapy: Crestor~Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy."
199608|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|"standard-care lipid-lowering therapy: Zocor or Lipitor~standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.~Zocor, Lipitor [any dose] and Crestor [less than 40mg]"
199609|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|"aggressive lipid therapy: Crestor~Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy."
199610|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|"standard-care lipid-lowering therapy: Zocor or Lipitor~standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.~Zocor, Lipitor [any dose] and Crestor [less than 40mg]"
199611|NCT01567826|E2|Reported Event|Aggressive Lipid Therapy|aggressive lipid therapy: Crestor
199612|NCT01567826|E1|Reported Event|Standard of Care Lipid Therapy|standard-care lipid-lowering therapy: Zocor or Lipitor
199613|NCT01567462|B3|Baseline|Total|Total of all reporting groups
199614|NCT01567462|B2|Baseline|PK Button Vaporization Electrode|Participants completed a transurethral resection of a bladder tumor using a PK button vaporization electrode and all follow up procedures.
199615|NCT01567462|B1|Baseline|Monopolar Loop Electrocautery|Participants completed a transurethral resection of the bladder tumor (TURBT) using monopolar loop electrocautery and all follow up procedures.
199616|NCT01567462|P2|Participant Flow|PK Button Vaporization Electrode|Participants underwent a transurethral resection of a bladder tumor using a PK button vaporization electrode.
199617|NCT01567462|P1|Participant Flow|Monopolar Loop Electrocautery|Participants underwent a transurethral resection of the bladder tumor (TURBT) using monopolar loop electrocautery.
199618|NCT01567462|O2|Outcome|PK Button Vaporization Electrode|Participants underwent a transurethral resection of a bladder tumor using a PK button vaporization electrode.
199619|NCT01567462|O1|Outcome|Monopolar Loop Electrocautery|Participants underwent a transurethral resection of the bladder tumor (TURBT) using monopolar loop electrocautery.
199620|NCT01567462|O2|Outcome|PK Button Vaporization Electrode|Participants underwent a transurethral resection of a bladder tumor using a PK button vaporization electrode.
199621|NCT01567462|O1|Outcome|Monopolar Loop Electrocautery|Participants underwent a transurethral resection of the bladder tumor (TURBT) using monopolar loop electrocautery.
199622|NCT01567462|O2|Outcome|PK Button Vaporization Electrode|Participants underwent a transurethral resection of a bladder tumor using a PK button vaporization electrode.
199623|NCT01567462|O1|Outcome|Monopolar Loop Electrocautery|Participants underwent a transurethral resection of the bladder tumor (TURBT) using monopolar loop electrocautery.
199624|NCT01567462|O2|Outcome|PK Button Vaporization Electrode|Participants underwent a transurethral resection of a bladder tumor using a PK button vaporization electrode.
199625|NCT01567462|O1|Outcome|Monopolar Loop Electrocautery|Participants underwent a transurethral resection of the bladder tumor (TURBT) using monopolar loop electrocautery.
199626|NCT01567462|E2|Reported Event|PK Button Vaporization Electrode|Participants underwent a transurethral resection of a bladder tumor using a PK button vaporization electrode.
199627|NCT01567462|E1|Reported Event|Monopolar Loop Electrocautery|Participants underwent a transurethral resection of the bladder tumor (TURBT) using monopolar loop electrocautery.
199628|NCT01567371|B1|Baseline|LiDCO Rapid Monitor|
199629|NCT01567371|P1|Participant Flow|LiDCO Rapid Monitor|
199630|NCT01567371|O1|Outcome|LiDCO Rapid Monitor|
199631|NCT01567371|O1|Outcome|LiDCO Rapid Monitor|
199632|NCT01567371|E1|Reported Event|LiDCO Rapid Monitor|
199633|NCT01567163|B1|Baseline|All Participants|"Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle~Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-mg/m^2 intravenous infusion administered on Day 1 of 3-week cycle~Cycle 3 and beyond: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle"
199634|NCT01567163|P1|Participant Flow|All Participants|"Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle~Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-mg/m^2 intravenous infusion administered on Day 1 of 3-week cycle~Cycle 3 and beyond: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle"
199635|NCT01567163|O1|Outcome|Ramucirumab|Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion and followed by docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
199636|NCT01567163|O1|Outcome|Ramucirumab|Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
199637|NCT01567163|O1|Outcome|All Participants|"Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle~Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-mg/m^2 intravenous infusion administered on Day 1 of 3-week cycle~Cycle 3 and beyond: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle"
199638|NCT01567163|O1|Outcome|Docetaxel (Cycle 2)|Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
199639|NCT01567163|O1|Outcome|Docetaxel (Cycle 1)|Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
199640|NCT01567163|O1|Outcome|Docetaxel (Cycle 2)|Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion and followed by docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
199641|NCT01567163|O1|Outcome|Docetaxel (Cycle 1)|Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
199642|NCT01567163|E1|Reported Event|All Participants|"Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle~Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-mg/m^2 intravenous infusion administered on Day 1 of 3-week cycle~Cycle 3 and beyond: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle"
199643|NCT01567150|B3|Baseline|Total|Total of all reporting groups
199644|NCT01567150|B2|Baseline|Control|Control is treatment without novel dressing
199645|NCT01567150|B1|Baseline|Novel Dressing|"Treatment with novel dressing~Novel Dressing: Topical wound dressing"
199646|NCT01567150|P2|Participant Flow|Control|Control is treatment without novel dressing
199647|NCT01567150|P1|Participant Flow|Novel Dressing|"Treatment with novel dressing~Novel Dressing: Topical wound dressing"
199648|NCT01567150|O2|Outcome|Control|Control is treatment without novel dressing
199649|NCT01567150|O1|Outcome|Novel Dressing|"Treatment with novel dressing~Novel Dressing: Topical wound dressing"
199650|NCT01567150|O2|Outcome|Control|Control is treatment without novel dressing
199651|NCT01567150|O1|Outcome|Novel Dressing|"Treatment with novel dressing~Novel Dressing: Topical wound dressing"
199652|NCT01567150|E2|Reported Event|Control|Control is treatment without novel dressing
199653|NCT01567150|E1|Reported Event|Novel Dressing|"Treatment with novel dressing~Novel Dressing: Topical wound dressing"
199654|NCT01567020|B5|Baseline|Total|Total of all reporting groups
199655|NCT01567020|B4|Baseline|Older|"Non-blast-exposed and non-TBI, aged 50 or older~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
199656|NCT01567020|B3|Baseline|Non-Blast-Exposed TBI|"Non-blast-exposed with TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
199657|NCT01567020|B2|Baseline|Blast|"Blast-exposed with or without a TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
199658|NCT01567020|B1|Baseline|Control|"Non-blast-exposed and non-TBI, aged younger than 50~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
199659|NCT01567020|P4|Participant Flow|Older|"Non-blast-exposed and non-TBI, aged 50 or older~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
199660|NCT01567020|P3|Participant Flow|Non-Blast-Exposed TBI|"Non-blast-exposed with TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
199661|NCT01567020|P2|Participant Flow|Blast|"Blast-exposed with or without a TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
199662|NCT01567020|P1|Participant Flow|Control|"Non-blast-exposed and non-TBI, aged younger than 50~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
199663|NCT01567020|O4|Outcome|Older|"Non-blast-exposed and non-TBI, aged 50 or older~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
199664|NCT01567020|O3|Outcome|Non-Blast-Exposed TBI|"Non-blast-exposed with TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
199665|NCT01567020|O2|Outcome|Blast|"Blast-exposed with or without a TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
199666|NCT01567020|O1|Outcome|Control|"Non-blast-exposed and non-TBI, aged younger than 50~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
199667|NCT01567020|E4|Reported Event|Older|"Non-blast-exposed and non-TBI, aged 50 or older~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
199668|NCT01567020|E3|Reported Event|Non-Blast-Exposed TBI|"Non-blast-exposed with TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
199669|NCT01567020|E2|Reported Event|Blast|"Blast-exposed with or without a TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
199670|NCT01567020|E1|Reported Event|Control|"Non-blast-exposed and non-TBI, aged younger than 50~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
199671|NCT01566981|B3|Baseline|Total|Total of all reporting groups
199672|NCT01566981|B2|Baseline|Diabetes Without Support|The group of randomly selected patients with DM type II, without software application and web-based support.
199673|NCT01566981|B1|Baseline|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with Diabetes mellitus (DM) type II, who will get the software application and web- based support Intervention: Computerized support to the Diabetes type II patients~Computerized support to the Diabetes type II patients: The randomly selected group of patients with diabetes type II will get software application and web based support to their usual healthcare process."
199674|NCT01566981|P2|Participant Flow|Diabetes Without Support|"62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support.~8 patients were lost to follow up, so 54 patients were included in final analysis."
199779|NCT01566773|O5|Outcome|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
199780|NCT01566773|O4|Outcome|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
199781|NCT01566773|O3|Outcome|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
199782|NCT01566773|O2|Outcome|GP MDI 9 µg BID|GP MDI 9 µg BID.
199675|NCT01566981|P1|Participant Flow|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients~Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process.~5 patients were lost to follow up, consequently 53 patients were included in final analysis"
199676|NCT01566981|O2|Outcome|Diabetes Without Support|"62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support.~8 patients were lost to follow and 54 patients were included in final analysis."
199677|NCT01566981|O1|Outcome|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients~Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process.~5 patients were lost to follow up, consequently 53 patients were included in final analysis"
199678|NCT01566981|O2|Outcome|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with Diabetes mellitus (DM) type II, who will get the software application and web- based support Intervention: Computerized support to the Diabetes type II patients~Computerized support to the Diabetes type II patients: The randomly selected group of patients with diabetes type II will get software application and web based support to their usual healthcare process."
199679|NCT01566981|O1|Outcome|Diabetes Without Support|The group of randomly selected patients with DM type II, without software application and web-based support.
199680|NCT01566981|O2|Outcome|Diabetes Without Support|"62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support.~8 patients were lost to follow and 54 patients were included in final analysis."
199681|NCT01566981|O1|Outcome|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients~Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process.~5 patients were lost to follow up, consequently 53 patients were included in final analysis"
199682|NCT01566981|E2|Reported Event|Diabetes Without Support|"62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support.~8 patients were lost to follow up and 12 patients missed final consultation. 54 patients were included in final analysis."
199683|NCT01566981|E1|Reported Event|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients~Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process.~5 patients were lost to follow up and 13 patients missed final consultation, consequently 53 patients were included in final analysis"
199684|NCT01566838|B3|Baseline|Total|Total of all reporting groups
199685|NCT01566838|B2|Baseline|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
199686|NCT01566838|B1|Baseline|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
199687|NCT01566838|P2|Participant Flow|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
199783|NCT01566773|O1|Outcome|GP MDI 18 µg BID|GP MDI 18 µg BID.
199784|NCT01566773|O8|Outcome|Spiriva® Handihaler®|Spiriva® Handihaler® (Tiotropium Bromide).
199785|NCT01566773|O7|Outcome|Placebo MDI|Placebo MDI.
199786|NCT01566773|O6|Outcome|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
199787|NCT01566773|O5|Outcome|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
199788|NCT01566773|O4|Outcome|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
199789|NCT01566773|O3|Outcome|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
199790|NCT01566773|O2|Outcome|GP MDI 9 µg BID|GP MDI 9 µg BID.
199791|NCT01566773|O1|Outcome|GP MDI 18 µg BID|GP MDI 18 µg BID.
199688|NCT01566838|P1|Participant Flow|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Three patients did not have follow-up data for the study and were therefore excluded from analysis~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
199689|NCT01566838|O2|Outcome|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
199690|NCT01566838|O1|Outcome|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
199691|NCT01566838|O2|Outcome|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
199692|NCT01566838|O1|Outcome|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
199693|NCT01566838|O2|Outcome|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
199694|NCT01566838|O1|Outcome|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
199792|NCT01566773|O8|Outcome|Spiriva® Handihaler®|Spiriva® Handihaler® (Tiotropium Bromide).
199793|NCT01566773|O7|Outcome|Placebo MDI|Placebo MDI.
199794|NCT01566773|O6|Outcome|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
199795|NCT01566773|O5|Outcome|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
199796|NCT01566773|O4|Outcome|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
199797|NCT01566773|O3|Outcome|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
199798|NCT01566773|O2|Outcome|GP MDI 9 µg BID|GP MDI 9 µg BID.
199799|NCT01566773|O1|Outcome|GP MDI 18 µg BID|GP MDI 18 µg BID.
199800|NCT01566773|O8|Outcome|Spiriva Respimat|Spiriva Respimat 18 µg
199695|NCT01566838|O2|Outcome|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
199696|NCT01566838|O1|Outcome|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
199697|NCT01566838|O2|Outcome|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
199698|NCT01566838|O1|Outcome|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
199699|NCT01566838|O2|Outcome|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
199700|NCT01566838|O1|Outcome|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
199701|NCT01566838|E2|Reported Event|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
199801|NCT01566773|O7|Outcome|Placebo MDI|Placebo MDI.
199802|NCT01566773|O6|Outcome|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
199803|NCT01566773|O5|Outcome|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
199804|NCT01566773|O4|Outcome|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
199805|NCT01566773|O3|Outcome|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
199806|NCT01566773|O2|Outcome|GP MDI 9 µg BID|GP MDI 9 µg BID.
199807|NCT01566773|O1|Outcome|GP MDI 18 µg BID|GP MDI 18 µg BID.
199808|NCT01566773|O7|Outcome|Placebo MDI|Placebo MDI.
199809|NCT01566773|O6|Outcome|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
199702|NCT01566838|E1|Reported Event|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
199703|NCT01566773|B1|Baseline|All Subjects|All Subjects
199704|NCT01566773|P1|Participant Flow|All Subjects|
199705|NCT01566773|O8|Outcome|Spiriva® Handihaler®|Spiriva® Handihaler® (Tiotropium Bromide).
199706|NCT01566773|O7|Outcome|Placebo MDI|Placebo MDI.
199707|NCT01566773|O6|Outcome|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
199708|NCT01566773|O5|Outcome|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
199709|NCT01566773|O4|Outcome|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
199710|NCT01566773|O3|Outcome|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
199711|NCT01566773|O2|Outcome|GP MDI 9 µg BID|GP MDI 9 µg BID.
199712|NCT01566773|O1|Outcome|GP MDI 18 µg BID|GP MDI 18 µg BID.
199713|NCT01566773|O8|Outcome|Spiriva® Handihaler®|Spiriva® Handihaler® (Tiotropium Bromide).
199714|NCT01566773|O7|Outcome|Placebo MDI|Placebo MDI.
199715|NCT01566773|O6|Outcome|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
199716|NCT01566773|O5|Outcome|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
199717|NCT01566773|O4|Outcome|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
199718|NCT01566773|O3|Outcome|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
199719|NCT01566773|O2|Outcome|GP MDI 9 µg BID|GP MDI 9 µg BID.
199720|NCT01566773|O1|Outcome|GP MDI 18 µg BID|GP MDI 18 µg BID.
199721|NCT01566773|O8|Outcome|Spiriva® Handihaler®|Spiriva® Handihaler® (Tiotropium Bromide).
199722|NCT01566773|O7|Outcome|Placebo MDI|Placebo MDI.
199723|NCT01566773|O6|Outcome|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
199724|NCT01566773|O5|Outcome|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
199725|NCT01566773|O4|Outcome|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
199726|NCT01566773|O3|Outcome|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
199727|NCT01566773|O2|Outcome|GP MDI 9 µg BID|GP MDI 9 µg BID.
199728|NCT01566773|O1|Outcome|GP MDI 18 µg BID|GP MDI 18 µg BID.
199729|NCT01566773|O7|Outcome|Placebo MDI|Placebo MDI.
199730|NCT01566773|O6|Outcome|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
199731|NCT01566773|O5|Outcome|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
199732|NCT01566773|O4|Outcome|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
199733|NCT01566773|O3|Outcome|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
199734|NCT01566773|O2|Outcome|GP MDI 9 µg BID|GP MDI 9 µg BID.
199735|NCT01566773|O1|Outcome|GP MDI 18 µg BID|GP MDI 18 µg BID.
199736|NCT01566773|O8|Outcome|Spiriva® Handihaler®|Spiriva® Handihaler® (Tiotropium Bromide).
199737|NCT01566773|O7|Outcome|Placebo MDI|Placebo MDI.
199738|NCT01566773|O6|Outcome|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
199739|NCT01566773|O5|Outcome|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
199740|NCT01566773|O4|Outcome|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
199741|NCT01566773|O3|Outcome|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
199742|NCT01566773|O2|Outcome|GP MDI 9 µg BID|GP MDI 9 µg BID.
199743|NCT01566773|O1|Outcome|GP MDI 18 µg BID|GP MDI 18 µg BID.
199744|NCT01566773|O8|Outcome|Spiriva® Handihaler®|Spiriva® Handihaler® (Tiotropium Bromide).
199745|NCT01566773|O7|Outcome|Placebo MDI|Placebo MDI.
199746|NCT01566773|O6|Outcome|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
199747|NCT01566773|O5|Outcome|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
199748|NCT01566773|O4|Outcome|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
199749|NCT01566773|O3|Outcome|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
199750|NCT01566773|O2|Outcome|GP MDI 9 µg BID|GP MDI 9 µg BID.
199751|NCT01566773|O1|Outcome|GP MDI 18 µg BID|GP MDI 18 µg BID.
199752|NCT01566773|O8|Outcome|Spiriva® Handihaler®|Spiriva® Handihaler® (Tiotropium Bromide).
199753|NCT01566773|O7|Outcome|Placebo MDI|Placebo MDI.
199754|NCT01566773|O6|Outcome|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
199755|NCT01566773|O5|Outcome|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
199756|NCT01566773|O4|Outcome|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
199757|NCT01566773|O3|Outcome|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
199758|NCT01566773|O2|Outcome|GP MDI 9 µg BID|GP MDI 9 µg BID.
199759|NCT01566773|O1|Outcome|GP MDI 18 µg BID|GP MDI 18 µg BID.
199760|NCT01566773|O8|Outcome|Spiriva® Handihaler®|Spiriva® Handihaler® (Tiotropium Bromide).
199761|NCT01566773|O7|Outcome|Placebo MDI|Placebo MDI.
199762|NCT01566773|O6|Outcome|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
199763|NCT01566773|O5|Outcome|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
199764|NCT01566773|O4|Outcome|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
199765|NCT01566773|O3|Outcome|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
199766|NCT01566773|O2|Outcome|GP MDI 9 µg BID|GP MDI 9 µg BID.
199767|NCT01566773|O1|Outcome|GP MDI 18 µg BID|GP MDI 18 µg BID.
199768|NCT01566773|O8|Outcome|Spiriva® Handihaler®|Spiriva® Handihaler® (Tiotropium Bromide).
199769|NCT01566773|O7|Outcome|Placebo MDI|Placebo MDI.
199770|NCT01566773|O6|Outcome|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
199771|NCT01566773|O5|Outcome|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
199772|NCT01566773|O4|Outcome|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
199773|NCT01566773|O3|Outcome|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
199774|NCT01566773|O2|Outcome|GP MDI 9 µg BID|GP MDI 9 µg BID.
199823|NCT01566773|O8|Outcome|Spiriva® Handihaler®|Spiriva® Handihaler® (Tiotropium Bromide).
199824|NCT01566773|O7|Outcome|Placebo MDI|Placebo MDI.
199825|NCT01566773|O6|Outcome|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
199826|NCT01566773|O5|Outcome|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
199827|NCT01566773|O4|Outcome|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
199828|NCT01566773|O3|Outcome|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
199829|NCT01566773|O2|Outcome|GP MDI 9 µg BID|GP MDI 9 µg BID.
199830|NCT01566773|O1|Outcome|GP MDI 18 µg BID|GP MDI 18 µg BID.
199831|NCT01566773|O8|Outcome|Spiriva® Handihaler®|Spiriva® Handihaler® (Tiotropium Bromide).
199832|NCT01566773|O7|Outcome|Placebo MDI|Placebo MDI.
199833|NCT01566773|O6|Outcome|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
199834|NCT01566773|O5|Outcome|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
199835|NCT01566773|O4|Outcome|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
199836|NCT01566773|O3|Outcome|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
199837|NCT01566773|O2|Outcome|GP MDI 9 µg BID|GP MDI 9 µg BID.
199838|NCT01566773|O1|Outcome|GP MDI 18 µg BID|GP MDI 18 µg BID.
199839|NCT01566773|O8|Outcome|Spiriva® Handihaler®|Spiriva® Handihaler® (Tiotropium Bromide).
199840|NCT01566773|O7|Outcome|Placebo MDI|Placebo MDI.
199841|NCT01566773|O6|Outcome|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
199842|NCT01566773|O5|Outcome|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
199843|NCT01566773|O4|Outcome|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
199844|NCT01566773|O3|Outcome|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
199845|NCT01566773|O2|Outcome|GP MDI 9 µg BID|GP MDI 9 µg BID.
199846|NCT01566773|O1|Outcome|GP MDI 18 µg BID|GP MDI 18 µg BID.
199847|NCT01566773|O8|Outcome|Spiriva® Handihaler®|Spiriva® Handihaler® (Tiotropium Bromide).
199848|NCT01566773|O7|Outcome|Placebo MDI|Placebo MDI.
199849|NCT01566773|O6|Outcome|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
199850|NCT01566773|O5|Outcome|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
199851|NCT01566773|O4|Outcome|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
199852|NCT01566773|O3|Outcome|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
199853|NCT01566773|O2|Outcome|GP MDI 9 µg BID|GP MDI 9 µg BID.
199854|NCT01566773|O1|Outcome|GP MDI 18 µg BID|GP MDI 18 µg BID.
199855|NCT01566773|O8|Outcome|Spiriva® Handihaler®|Spiriva® Handihaler® (Tiotropium Bromide).
199856|NCT01566773|O7|Outcome|Placebo MDI|Placebo MDI.
199857|NCT01566773|O6|Outcome|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
199858|NCT01566773|O5|Outcome|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
199859|NCT01566773|O4|Outcome|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
199860|NCT01566773|O3|Outcome|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
199861|NCT01566773|O2|Outcome|GP MDI 9 µg BID|GP MDI 9 µg BID.
199862|NCT01566773|O1|Outcome|GP MDI 18 µg BID|GP MDI 18 µg BID.
199863|NCT01566773|O8|Outcome|Spiriva® Handihaler®|Spiriva® Handihaler® (Tiotropium Bromide).
199864|NCT01566773|O7|Outcome|Placebo MDI|Placebo MDI.
199865|NCT01566773|O6|Outcome|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
199866|NCT01566773|O5|Outcome|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
199867|NCT01566773|O4|Outcome|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
199868|NCT01566773|O3|Outcome|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
199869|NCT01566773|O2|Outcome|GP MDI 9 µg BID|GP MDI 9 µg BID.
199870|NCT01566773|O1|Outcome|GP MDI 18 µg BID|GP MDI 18 µg BID.
199871|NCT01566773|O7|Outcome|Spiriva® Handihaler®|Spiriva® Handihaler® (Tiotropium Bromide).
199872|NCT01566773|O6|Outcome|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
199873|NCT01566773|O5|Outcome|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
199874|NCT01566773|O4|Outcome|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
199875|NCT01566773|O3|Outcome|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
199876|NCT01566773|O2|Outcome|GP MDI 9 µg BID|GP MDI 9 µg BID.
199877|NCT01566773|O1|Outcome|GP MDI 18 µg BID|GP MDI 18 µg BID.
199878|NCT01566773|O8|Outcome|Spiriva® Handihaler®|Spiriva® Handihaler® (Tiotropium Bromide).
199879|NCT01566773|O7|Outcome|Placebo MDI|Placebo MDI.
199880|NCT01566773|O6|Outcome|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
199881|NCT01566773|O5|Outcome|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
199882|NCT01566773|O4|Outcome|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
199883|NCT01566773|O3|Outcome|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
199884|NCT01566773|O2|Outcome|GP MDI 9 µg BID|GP MDI 9 µg BID.
199885|NCT01566773|O1|Outcome|GP MDI 18 µg BID|GP MDI 18 µg BID.
199886|NCT01566773|O8|Outcome|Spiriva® Handihaler®|Spiriva® Handihaler® (Tiotropium Bromide).
199887|NCT01566773|O7|Outcome|Placebo MDI|Placebo MDI.
199888|NCT01566773|O6|Outcome|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
199889|NCT01566773|O5|Outcome|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
199890|NCT01566773|O4|Outcome|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
199891|NCT01566773|O3|Outcome|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
199892|NCT01566773|O2|Outcome|GP MDI 9 µg BID|GP MDI 9 µg BID.
199893|NCT01566773|O1|Outcome|GP MDI 18 µg BID|GP MDI 18 µg BID.
199894|NCT01566773|O8|Outcome|Spiriva® Handihaler®|Spiriva® Handihaler® (Tiotropium Bromide).
199895|NCT01566773|O7|Outcome|Placebo MDI|Placebo MDI.
199896|NCT01566773|O6|Outcome|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
199897|NCT01566773|O5|Outcome|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
199898|NCT01566773|O4|Outcome|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
199899|NCT01566773|O3|Outcome|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
199900|NCT01566773|O2|Outcome|GP MDI 9 µg BID|GP MDI 9 µg BID.
199901|NCT01566773|O1|Outcome|GP MDI 18 µg BID|GP MDI 18 µg BID.
199902|NCT01566773|E8|Reported Event|Spiriva 18 µg|Spiriva 18 µg
199903|NCT01566773|E7|Reported Event|Placebo MDI|Placebo MDI.
199904|NCT01566773|E6|Reported Event|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
199905|NCT01566773|E5|Reported Event|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
199906|NCT01566773|E4|Reported Event|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
199907|NCT01566773|E3|Reported Event|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
199908|NCT01566773|E2|Reported Event|GP MDI 9 µg BID|GP MDI 9 µg BID.
199909|NCT01566773|E1|Reported Event|GP MDI 18 µg BID|GP MDI 18 µg BID.
199910|NCT01566721|B3|Baseline|Total|Total of all reporting groups
199911|NCT01566721|B2|Baseline|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
199912|NCT01566721|B1|Baseline|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
199913|NCT01566721|P2|Participant Flow|Cohort B: SC Herceptin by Single-Use Injection Device (SID)|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by a healthcare professional (HCP). Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
199914|NCT01566721|P1|Participant Flow|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
199915|NCT01566721|O1|Outcome|Cohort B: SC Herceptin by SID (Self- Administered)|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. Dosing was either performed by self-administration or a qualified HCP. The present subgroup included only participants for whom SC Herceptin was given by self- administration.
199916|NCT01566721|O2|Outcome|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
199917|NCT01566721|O1|Outcome|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
199918|NCT01566721|O2|Outcome|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
199919|NCT01566721|O1|Outcome|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
199920|NCT01566721|O2|Outcome|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
199921|NCT01566721|O1|Outcome|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
199922|NCT01566721|O3|Outcome|Cohort B: SC Herceptin by SID (Self- Administered)|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. Dosing was either performed by self-administration or a qualified HCP. The present subgroup included only participants for whom SC Herceptin was given by self- administration.
199923|NCT01566721|O2|Outcome|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
199924|NCT01566721|O1|Outcome|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
199925|NCT01566721|O3|Outcome|Cohort B: SC Herceptin by SID (Self-Administered)|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. Dosing was either performed by self-administration or a qualified HCP. The present subgroup included only participants for whom SC Herceptin was given by self-administration.
199926|NCT01566721|O2|Outcome|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
199927|NCT01566721|O1|Outcome|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
199928|NCT01566721|O2|Outcome|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
199929|NCT01566721|O1|Outcome|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
199959|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
200238|NCT01566149|E2|Reported Event|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
199930|NCT01566721|O2|Outcome|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
199931|NCT01566721|O1|Outcome|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
199932|NCT01566721|O2|Outcome|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
199933|NCT01566721|O1|Outcome|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
199934|NCT01566721|E2|Reported Event|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
199935|NCT01566721|E1|Reported Event|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
199936|NCT01566630|B3|Baseline|Total|Total of all reporting groups
199937|NCT01566630|B2|Baseline|Placebo|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. The randomized patient received matching placebo of serelaxin (RLX030) in a blinded manner.
199938|NCT01566630|B1|Baseline|RLX030|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. As per planned treatment assigned, patients in this arm received open label serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours.
199939|NCT01566630|P2|Participant Flow|Placebo|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. The randomized patient received matching placebo of serelaxin (RLX030) in a blinded manner.
199940|NCT01566630|P1|Participant Flow|RLX030|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. As per planned treatment assigned, patients in this arm received open label serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours.
199941|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
199942|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
199943|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
199944|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
199945|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
199946|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
199947|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
199948|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
199949|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
199950|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
199951|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
199952|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
199953|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
199954|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
199955|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
199956|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
199957|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
199958|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
199960|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
199961|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
199962|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
199963|NCT01566630|O2|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
199964|NCT01566630|O1|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
199965|NCT01566630|O2|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
199966|NCT01566630|O1|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
199967|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
199968|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
199969|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
199970|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
199971|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
199972|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
199973|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
199974|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
199975|NCT01566630|O2|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
199976|NCT01566630|O1|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
199977|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
199978|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
199979|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
199980|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
199981|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
199982|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
199983|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
199984|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
199985|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
199986|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
199987|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
199988|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
199989|NCT01566630|E4|Reported Event|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
199990|NCT01566630|E3|Reported Event|Placebo- Maternal|Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
199991|NCT01566630|E2|Reported Event|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
199992|NCT01566630|E1|Reported Event|RLX030- Maternal|Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
199993|NCT01566604|B3|Baseline|Total|Total of all reporting groups
199994|NCT01566604|B2|Baseline|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
199995|NCT01566604|B1|Baseline|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
199996|NCT01566604|P2|Participant Flow|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
199997|NCT01566604|P1|Participant Flow|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
199998|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
199999|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
200000|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
200001|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
200002|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
200003|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
200004|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
200005|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
200006|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
200007|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
200008|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
200009|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
200010|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
200011|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
200012|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
200013|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
200014|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
200015|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
200016|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
200017|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
200018|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
200019|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
200020|NCT01566604|E2|Reported Event|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
200021|NCT01566604|E1|Reported Event|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
200022|NCT01566539|B9|Baseline|Total|Total of all reporting groups
200023|NCT01566539|B8|Baseline|Healthy Volunteers - Lorazepam|"Healthy normal men between the ages of 18 and 22 will receive lorazepam prior to completing the Prisoner's Dilemma game task and MRI scan.~Lorazepam: Subjects will take 1.0 mg of lorazepam orally 60 minutes prior to fMRI scan."
200024|NCT01566539|B7|Baseline|Empathy Task - Placebo|"Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and placebo at scan 2 prior to completing an empathy task.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200025|NCT01566539|B6|Baseline|Empathy Task - Oxytocin (OT)|"Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and OT at scan 2 prior to completing an empathy task.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200026|NCT01566539|B5|Baseline|Faces Task - Placebo|"Healthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200027|NCT01566539|B4|Baseline|Faces Task - Vasopressin (AVP)|"Healthy volunteers between the ages of 21-30 years will receive Faces Intranasal Vasopressin (AVP) prior to completing the Faces task during fMRI scanning.~Intranasal Vasopressin (AVP) 40 IU: Participants will self-administer a 0.5 ml solution containing 40 international units (IU) of AVP. 5 puffs in total, each with 4 International Units (IU) AVP."
200028|NCT01566539|B3|Baseline|Healthy Volunteers - Intranasal Placebo|"The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200029|NCT01566539|B2|Baseline|Healthy Volunteers - Intranasal Oxytocin (OT)|"The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total."
200030|NCT01566539|B1|Baseline|Healthy Volunteers - Intranasal Vasopressin (AVP)|"The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.~Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total)."
200031|NCT01566539|P9|Participant Flow|Healthy Volunteers - Lorazepam|"Healthy normal men between the ages of 18 and 22 will receive lorazepam prior to completing the Prisoner's Dilemma game task and MRI scan.~Lorazepam: Subjects will take 1.0 mg of lorazepam orally 60 minutes prior to fMRI scan."
209223|NCT01530477|B4|Baseline|Total|Total of all reporting groups
200032|NCT01566539|P8|Participant Flow|Empathy Task - Placebo|"Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and placebo at scan 2 prior to completing an empathy task.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200033|NCT01566539|P7|Participant Flow|Empathy Task - Oxytocin (OT)|"Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and OT at scan 2 prior to completing an empathy task.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200034|NCT01566539|P6|Participant Flow|Faces Task - Placebo|"Healthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200035|NCT01566539|P5|Participant Flow|Faces Task - Vasopressin (AVP)|"Healthy volunteers between the ages of 21-30 years will receive Faces Intranasal Vasopressin (AVP) prior to completing the Faces task during fMRI scanning.~Intranasal Vasopressin (AVP) 40 IU: Participants will self-administer a 0.5 ml solution containing 40 international units (IU) of AVP. 5 puffs in total, each with 4 International Units (IU) AVP."
200036|NCT01566539|P4|Participant Flow|Within Subject Group|"Some healthy volunteer participants who received drug in their first session will receive placebo in their second session and vice-versa prior to completing the PD task. For each gender, half will receive AVP in one session and placebo in the other session, and half will receive OT in one session and placebo in the second session. In each group, half of the subjects will receive drug first and half will receive placebo first. Additionally, a group of subjects who receive placebo the first time will receive placebo the second time.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.~Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total).~Intranasal Placebo: Participants will receive placebo sprays that are pH"
200037|NCT01566539|P3|Participant Flow|Healthy Volunteers - Intranasal Placebo|"The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200038|NCT01566539|P2|Participant Flow|Healthy Volunteers - Intranasal Oxytocin (OT)|"The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total."
200039|NCT01566539|P1|Participant Flow|Healthy Volunteers - Intranasal Vasopressin (AVP)|"The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.~Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total)."
200040|NCT01566539|O3|Outcome|Healthy Volunteers - Intranasal Placebo|"The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200041|NCT01566539|O2|Outcome|Healthy Volunteers - Intranasal Oxytocin (OT)|"The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total."
200042|NCT01566539|O1|Outcome|Healthy Volunteers - Intranasal Vasopressin (AVP)|"The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.~Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total)."
200043|NCT01566539|O3|Outcome|Healthy Volunteers - Intranasal Placebo|"The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200044|NCT01566539|O2|Outcome|Healthy Volunteers - Intranasal Oxytocin (OT)|"The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total."
200045|NCT01566539|O1|Outcome|Healthy Volunteers - Intranasal Vasopressin (AVP)|"The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.~Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total)."
200046|NCT01566539|O3|Outcome|Healthy Volunteers - Intranasal Placebo|"The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200047|NCT01566539|O2|Outcome|Healthy Volunteers - Intranasal Oxytocin (OT)|"The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total."
200048|NCT01566539|O1|Outcome|Healthy Volunteers - Intranasal Vasopressin (AVP)|"The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.~Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total)."
200049|NCT01566539|O2|Outcome|Empathy Task - Placebo|"Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and placebo at scan 2 prior to completing an empathy task.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200050|NCT01566539|O1|Outcome|Empathy Task - Oxytocin (OT)|"Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and OT at scan 2 prior to completing an empathy task.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200051|NCT01566539|O2|Outcome|Empathy Task - Placebo|"Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and placebo at scan 2 prior to completing an empathy task.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200052|NCT01566539|O1|Outcome|Empathy Task - Oxytocin (OT)|"Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and OT at scan 2 prior to completing an empathy task.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200053|NCT01566539|O2|Outcome|Faces Task - Placebo|"Healthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200054|NCT01566539|O1|Outcome|Faces Task - Vasopressin (AVP)|"Healthy volunteers between the ages of 21-30 years will receive Faces Intranasal Vasopressin (AVP) prior to completing the Faces task during fMRI scanning.~Intranasal Vasopressin (AVP) 40 IU: Participants will self-administer a 0.5 ml solution containing 40 international units (IU) of AVP. 5 puffs in total, each with 4 International Units (IU) AVP."
200055|NCT01566539|O2|Outcome|Faces Task - Placebo|"Healthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200056|NCT01566539|O1|Outcome|Faces Task - Vasopressin (AVP)|"Healthy volunteers between the ages of 21-30 years will receive Faces Intranasal Vasopressin (AVP) prior to completing the Faces task during fMRI scanning.~Intranasal Vasopressin (AVP) 40 IU: Participants will self-administer a 0.5 ml solution containing 40 international units (IU) of AVP. 5 puffs in total, each with 4 International Units (IU) AVP."
200057|NCT01566539|O2|Outcome|Faces Task - Placebo|"Healthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200058|NCT01566539|O1|Outcome|Faces Task - Vasopressin (AVP)|"Healthy volunteers between the ages of 21-30 years will receive Faces Intranasal Vasopressin (AVP) prior to completing the Faces task during fMRI scanning.~Intranasal Vasopressin (AVP) 40 IU: Participants will self-administer a 0.5 ml solution containing 40 international units (IU) of AVP. 5 puffs in total, each with 4 International Units (IU) AVP."
200059|NCT01566539|O2|Outcome|Faces Task - Placebo|"Healthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200060|NCT01566539|O1|Outcome|Faces Task - Vasopressin (AVP)|"Healthy volunteers between the ages of 21-30 years will receive Faces Intranasal Vasopressin (AVP) prior to completing the Faces task during fMRI scanning.~Intranasal Vasopressin (AVP) 40 IU: Participants will self-administer a 0.5 ml solution containing 40 international units (IU) of AVP. 5 puffs in total, each with 4 International Units (IU) AVP."
200061|NCT01566539|O2|Outcome|Faces Task - Placebo|"Healthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200062|NCT01566539|O1|Outcome|Faces Task - Vasopressin (AVP)|"Healthy volunteers between the ages of 21-30 years will receive Faces Intranasal Vasopressin (AVP) prior to completing the Faces task during fMRI scanning.~Intranasal Vasopressin (AVP) 40 IU: Participants will self-administer a 0.5 ml solution containing 40 international units (IU) of AVP. 5 puffs in total, each with 4 International Units (IU) AVP."
200063|NCT01566539|O2|Outcome|Faces Task - Placebo|"Healthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200064|NCT01566539|O1|Outcome|Faces Task - Vasopressin (AVP)|"Healthy volunteers between the ages of 21-30 years will receive Faces Intranasal Vasopressin (AVP) prior to completing the Faces task during fMRI scanning.~Intranasal Vasopressin (AVP) 40 IU: Participants will self-administer a 0.5 ml solution containing 40 international units (IU) of AVP. 5 puffs in total, each with 4 International Units (IU) AVP."
200065|NCT01566539|O1|Outcome|Within Subject Group|Some healthy volunteer participants who received drug in their first session will receive placebo in their second session and vice-versa prior to completing the PD task. For each gender, half will receive AVP in one session and placebo in the other session, and half will receive OT in one session and placebo in the second session. In each group, half of the subjects will receive drug first and half will receive placebo first. Additionally, a group of subjects who receive placebo the first time will receive placebo the second time.
200066|NCT01566539|O1|Outcome|Within Subject Group|Some healthy volunteer participants who received drug in their first session will receive placebo in their second session and vice-versa prior to completing the PD task. For each gender, half will receive AVP in one session and placebo in the other session, and half will receive OT in one session and placebo in the second session. In each group, half of the subjects will receive drug first and half will receive placebo first. Additionally, a group of subjects who receive placebo the first time will receive placebo the second time.
200067|NCT01566539|O3|Outcome|Healthy Volunteers - Intranasal Placebo|"The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
211625|NCT01521143|B5|Baseline|Total|Total of all reporting groups
200068|NCT01566539|O2|Outcome|Healthy Volunteers - Intranasal Oxytocin (OT)|"The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total."
200069|NCT01566539|O1|Outcome|Healthy Volunteers - Intranasal Vasopressin (AVP)|"The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.~Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total)."
200070|NCT01566539|O3|Outcome|Healthy Volunteers - Intranasal Placebo|"The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200071|NCT01566539|O2|Outcome|Healthy Volunteers - Intranasal Oxytocin (OT)|"The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total."
200072|NCT01566539|O1|Outcome|Healthy Volunteers - Intranasal Vasopressin (AVP)|"The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.~Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total)."
200073|NCT01566539|O1|Outcome|Within Subject Group|"Some healthy volunteer participants who received drug in their first session will receive placebo in their second session and vice-versa prior to completing the PD task. For each gender, half will receive AVP in one session and placebo in the other session, and half will receive OT in one session and placebo in the second session. In each group, half of the subjects will receive drug first and half will receive placebo first. Additionally, a group of subjects who receive placebo the first time will receive placebo the second time.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.~Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total).~Intranasal Placebo: Participants will receive placebo sprays that are pH"
200074|NCT01566539|O2|Outcome|Healthy Volunteers - Intranasal Placebo|"The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200075|NCT01566539|O1|Outcome|Healthy Volunteers - Intranasal Vasopressin (AVP)|"The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.~Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total)."
200076|NCT01566539|O2|Outcome|Healthy Volunteers - Intranasal Placebo|"The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200077|NCT01566539|O1|Outcome|Healthy Volunteers - Intranasal Vasopressin (AVP)|"The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.~Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total)."
200078|NCT01566539|O2|Outcome|Healthy Volunteers - Intranasal Placebo|"The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200079|NCT01566539|O1|Outcome|Healthy Volunteers - Intranasal Oxytocin (OT)|"The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total."
200080|NCT01566539|O2|Outcome|Healthy Volunteers - Intranasal Placebo|"The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200081|NCT01566539|O1|Outcome|Healthy Volunteers - Intranasal Oxytocin (OT)|"The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total."
200082|NCT01566539|E9|Reported Event|Healthy Volunteers - Lorazepam|"Healthy normal men between the ages of 18 and 22 will receive lorazepam prior to completing the Prisoner's Dilemma game task and MRI scan.~Lorazepam: Subjects will take 1.0 mg of lorazepam orally 60 minutes prior to fMRI scan."
200083|NCT01566539|E8|Reported Event|Empathy Task - Placebo|"Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and placebo at scan 2 prior to completing an empathy task.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200084|NCT01566539|E7|Reported Event|Empathy Task - Oxytocin (OT)|"Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and OT at scan 2 prior to completing an empathy task.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200085|NCT01566539|E6|Reported Event|Faces Task - Placebo|"Healthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200235|NCT01566149|O1|Outcome|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
200086|NCT01566539|E5|Reported Event|Faces Task - Vasopressin (AVP)|"Healthy volunteers between the ages of 21-30 years will receive Faces Intranasal Vasopressin (AVP) prior to completing the Faces task during fMRI scanning.~Intranasal Vasopressin (AVP) 40 IU: Participants will self-administer a 0.5 ml solution containing 40 international units (IU) of AVP. 5 puffs in total, each with 4 International Units (IU) AVP."
200087|NCT01566539|E4|Reported Event|Within Subject Group|"Some healthy volunteer participants who received drug in their first session will receive placebo in their second session and vice-versa prior to completing the PD task. For each gender, half will receive AVP in one session and placebo in the other session, and half will receive OT in one session and placebo in the second session. In each group, half of the subjects will receive drug first and half will receive placebo first. Additionally, a group of subjects who receive placebo the first time will receive placebo the second time.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.~Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total).~Intranasal Placebo: Participants will receive placebo sprays that are pH"
200088|NCT01566539|E3|Reported Event|Healthy Volunteers - Intranasal Placebo|"The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
200089|NCT01566539|E2|Reported Event|Healthy Volunteers - Intranasal Oxytocin (OT)|"The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total."
200090|NCT01566539|E1|Reported Event|Healthy Volunteers - Intranasal Vasopressin (AVP)|"The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.~Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total)."
200091|NCT01566526|B1|Baseline|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
200092|NCT01566526|P1|Participant Flow|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
200093|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
200094|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
200095|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
200096|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
200097|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
200098|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
200099|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
200100|NCT01566526|E1|Reported Event|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
200101|NCT01566500|B1|Baseline|Study Sample|Adults with self-reported epilepsy.
200102|NCT01566500|P1|Participant Flow|Study Sample|Adults with self-reported epilepsy.
200103|NCT01566500|O1|Outcome|Study Sample|Adults with self-reported epilepsy.
200104|NCT01566500|E1|Reported Event|Study Sample|Adults with self-reported epilepsy.
200105|NCT01566461|B3|Baseline|Total|Total of all reporting groups
200106|NCT01566461|B2|Baseline|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
200107|NCT01566461|B1|Baseline|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
200108|NCT01566461|P2|Participant Flow|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
200109|NCT01566461|P1|Participant Flow|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
200110|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200111|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200112|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200113|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
201381|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken, twice daily. 10 week treatment period.
200114|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200115|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200116|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200117|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200118|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200119|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200120|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200121|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200122|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200123|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200124|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200125|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200126|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200127|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200128|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200129|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200130|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200131|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200132|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200133|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200134|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200135|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200136|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200137|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200138|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200139|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200140|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200141|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200142|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200143|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200144|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200145|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200146|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200147|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200148|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200149|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
200150|NCT01566461|E2|Reported Event|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
200151|NCT01566461|E1|Reported Event|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
200152|NCT01566435|B1|Baseline|Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
200153|NCT01566435|P1|Participant Flow|Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m^2 on Days 1, 8, and 15~Cisplatin 75 mg/m^2 on Day 1~5-FU 750 mg/m^2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m^2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m^2 IV week for 8 weeks"
200154|NCT01566435|O1|Outcome|Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
200155|NCT01566435|O1|Outcome|Arm 1 (ACF)|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
200156|NCT01566435|O1|Outcome|Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
202024|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
200157|NCT01566435|O1|Outcome|Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
200158|NCT01566435|O1|Outcome|Arm 1 (ACF)|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
200159|NCT01566435|O1|Outcome|Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
200160|NCT01566435|O1|Outcome|Arm 1 (ACF)|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
200161|NCT01566435|O1|Outcome|Arm 1 (ACF)|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
200162|NCT01566435|O1|Outcome|Arm 1 (ACF)|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
200163|NCT01566435|E3|Reported Event|ACF Definitive Chemoradiation Therapy-cetuximab|"Definitive Therapy~Cetuximab 250 mg/m^2 IV weekly for 8 weeks~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions."
200164|NCT01566435|E2|Reported Event|ACF Definitive Chemoradiation Therapy-cisplatin|"Definitive Therapy~Cisplatin 100 mg/m^2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions."
200165|NCT01566435|E1|Reported Event|ACF Induction Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m^2 on Days 1, 8, and 15~Cisplatin 75 mg/m^2 on Day 1~5-FU 750 mg/m^2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF."
200166|NCT01566409|B3|Baseline|Total|Total of all reporting groups
200167|NCT01566409|B2|Baseline|Placebo Maintenance Treatment|Placebo: Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
200236|NCT01566149|O2|Outcome|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
200168|NCT01566409|B1|Baseline|Active Maintenance Treatment|Polyethylene glycol 3350: Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.
200169|NCT01566409|P2|Participant Flow|Placebo Maintenance Treatment|Placebo: Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
200170|NCT01566409|P1|Participant Flow|Active Maintenance Treatment|Polyethylene glycol 3350: Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.
200171|NCT01566409|O2|Outcome|Placebo Maintenance Treatment|Placebo: Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
200172|NCT01566409|O1|Outcome|Active Maintenance Treatment|Polyethylene glycol 3350: Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.
200173|NCT01566409|E2|Reported Event|Placebo Maintenance Treatment|Placebo: Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
200174|NCT01566409|E1|Reported Event|Active Maintenance Treatment|Polyethylene glycol 3350: Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.
200175|NCT01566370|B3|Baseline|Total|Total of all reporting groups
200176|NCT01566370|B2|Baseline|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
200177|NCT01566370|B1|Baseline|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
200178|NCT01566370|P2|Participant Flow|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
200179|NCT01566370|P1|Participant Flow|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
200180|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
200181|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
200182|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
200183|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
200184|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
200185|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
200186|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
200187|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
200188|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
200189|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
200190|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
200191|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
200192|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
200193|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
200237|NCT01566149|O1|Outcome|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
200194|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
200195|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
200196|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
200197|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
200198|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
200199|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
200200|NCT01566370|E2|Reported Event|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
200201|NCT01566370|E1|Reported Event|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
200202|NCT01566331|B3|Baseline|Total|Total of all reporting groups
200203|NCT01566331|B2|Baseline|Baby-guardTM With Minimal Inflation|Baby-guardTM system, with minimal inflation in women who expected natural delivery
200204|NCT01566331|B1|Baseline|Baby-guardTM|Baby-guardTM system, through its ergonomic, three chamber, inflatable abdominal belt, engineered after studies of biomechanics and biophysics, that follows obstetric semiotics, that applies fundal pressure during the second stage of labor in the direction of the pelvic outlet, may be of maternal and fetus aid for a safe natural childbirth for their better outcomes
200205|NCT01566331|P2|Participant Flow|Baby-guardTM Minimal Inflation|Baby-guardTM with minimal inflation who expected natural delivery
200206|NCT01566331|P1|Participant Flow|Baby-guardTM|"Baby-guardTM system, through its ergonomic, three chamber, inflatable abdominal belt, engineered after studies of biomechanics and biophysics, that follows obstetric semiotics, that applies fundal pressure during the second stage of labor in the direction of the pelvic outlet, may be of maternal and fetus aid for a safe natural childbirth for their better outcomes~Baby-guardTM: Baby-guardTM system, through its ergonomic, three chamber, inflatable abdominal belt, engineered after studies of biomechanics and biophysics, that follows obstetric semiotics, that applies fundal pressure during the second stage of labor in the direction of the pelvic outlet, may be of maternal and fetus aid for a safe natural childbirth for their better outcomes"
200207|NCT01566331|O2|Outcome|Baby-guardTM With Minimal Inflation|
200208|NCT01566331|O1|Outcome|Baby Belt Device Group|
200209|NCT01566331|E2|Reported Event|Baby Birth With Minimal Inflation|group delivering with dwvice and minimal inflation
200210|NCT01566331|E1|Reported Event|Baby Birth|group delivering with baby birth
200211|NCT01566162|B1|Baseline|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
200212|NCT01566162|P1|Participant Flow|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
200213|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
200214|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
200215|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
200216|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
200217|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
200218|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
200219|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
200220|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
200221|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
200222|NCT01566162|E1|Reported Event|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
200223|NCT01566149|B3|Baseline|Total|Total of all reporting groups
200224|NCT01566149|B2|Baseline|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
200225|NCT01566149|B1|Baseline|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
200226|NCT01566149|P2|Participant Flow|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
200227|NCT01566149|P1|Participant Flow|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
200228|NCT01566149|O2|Outcome|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
200229|NCT01566149|O1|Outcome|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
200230|NCT01566149|O2|Outcome|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
200231|NCT01566149|O1|Outcome|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
200232|NCT01566149|O2|Outcome|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
200233|NCT01566149|O1|Outcome|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
200234|NCT01566149|O2|Outcome|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
200239|NCT01566149|E1|Reported Event|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
200240|NCT01566084|B3|Baseline|Total|Total of all reporting groups
200241|NCT01566084|B2|Baseline|Placebo (Start)|"Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.~Subjects then cross over to the slow sodium tablet arm in the second half of the study."
200242|NCT01566084|B1|Baseline|Slow Sodium Tablets (Start)|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of a slow sodium tablets to bring them back up to a normal salt intake. This is administered through 10 tablets day.~Subjects then cross-over to the placebo arm in the second half of the study."
200243|NCT01566084|P2|Participant Flow|Placebo|"Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.~Subjects then cross over to the opposite condition in the second half of the study."
200244|NCT01566084|P1|Participant Flow|Slow Sodium Tablets (Start)|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~Subjects then cross over to the opposite condition in the second half of the study."
200245|NCT01566084|O4|Outcome|Low Sodium BH4|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~FMD is assessed following acute oral tetrahydrobiopterin (BH4) or placebo is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability."
200246|NCT01566084|O3|Outcome|Normal Sodium BH4|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~FMD is assessed following acute oral tetrahydrobiopterin (BH4) or placebo is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability."
200247|NCT01566084|O2|Outcome|Low Sodium Placebo|"Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.~FMD is assessed following acute oral tetrahydrobiopterin (BH4) or placebo is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability."
200248|NCT01566084|O1|Outcome|Normal Sodium Placebo|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~FMD is assessed following acute oral tetrahydrobiopterin (BH4) or placebo is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability."
200249|NCT01566084|O4|Outcome|Low Sodium Ascorbic Acid|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~FMD is assessed following an acute supraphysiological infusion of ascorbic acid (known to scavenge superoxide) compared to an equal volume of normal saline."
200250|NCT01566084|O3|Outcome|Normal Sodium Ascorbic Acid|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~FMD is assessed following an acute supraphysiological infusion of ascorbic acid (known to scavenge superoxide) compared to an equal volume of normal saline."
200251|NCT01566084|O2|Outcome|Low Sodium Saline|"Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.~FMD is assessed following an acute supraphysiological infusion of ascorbic acid (known to scavenge superoxide) compared to an equal volume of normal saline."
200252|NCT01566084|O1|Outcome|Normal Sodium Saline|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~FMD is assessed following an acute supraphysiological infusion of ascorbic acid (known to scavenge superoxide) compared to an equal volume of normal saline."
200253|NCT01566084|O2|Outcome|Low Sodium Diet.|Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.
200254|NCT01566084|O1|Outcome|Normal Sodium Diet|Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of a salt pill to bring them back up to a normal salt intake.
200255|NCT01566084|E2|Reported Event|Low Sodium|Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.
200256|NCT01566084|E1|Reported Event|Normal Sodium|Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.
200257|NCT01565993|B3|Baseline|Total|Total of all reporting groups
200258|NCT01565993|B2|Baseline|Group B: Conventional Polipectomy|In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique
200259|NCT01565993|B1|Baseline|Group A: Hemoclips|In group A, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop
200260|NCT01565993|P2|Participant Flow|Group B: Conventional Polipectomy|In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique
200261|NCT01565993|P1|Participant Flow|Group A: Hemoclips|In group A, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop
200262|NCT01565993|O2|Outcome|Conventional Polipectomy|In group CONVENTIONAL POLYPECTOMY, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique.Disposable electrosurgical snares (Olympus Medical Systems Corp. Hachioji-shi, Tokyo, Japan) and an electrosurgery unit ERBE (ERBE Elektromedizin GmbH, Germany) were used for polyp resection.
200263|NCT01565993|O1|Outcome|Hemoclip|"In group HEMOCLIP, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop. In all the polypectomies that were assigned to group HEMOCLIP, a rotatable clip-fixing device Quickclip 2 standard was used (Olympus Medical Systems Corp. Hachioji-shi, Tokyo, Japan), with an opening diameter of 135º and a maximum insertion portion diameter of 2.6 mm"
200264|NCT01565993|E2|Reported Event|Group B: Conventional Polipectomy|In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique
200265|NCT01565993|E1|Reported Event|Group A: Hemoclips|In group A, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop
200266|NCT01565980|B3|Baseline|Total|Total of all reporting groups
200354|NCT01565902|O5|Outcome|Matched Healthy Subjects - Moderate|Treatment with a single oral dose of 0.25 mg BAF312
200267|NCT01565980|B2|Baseline|Mindfulness Intervention|"Participants receive weekly symptom assessment phone calls.~Mindfulness Intervention: Participants receive 6 weekly sessions of a home delivered mindfulness intervention."
200268|NCT01565980|B1|Baseline|Attention Control|weekly symptom assessment phone calls.
200269|NCT01565980|P2|Participant Flow|Mindfulness Intervention|"Participants will receive 6 weeks of home-based mindfulness intervention.~Mindfulness Intervention: Participants will receive a weekly home-based mindfulness intervention.~Participants also receive weekly symptom assessment phone interview."
200270|NCT01565980|P1|Participant Flow|Symptom Assessment|"weekly phone calls.~symptom assessment: attention control group"
200271|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants will receive 6 weeks of home-based mindfulness intervention.~Mindfulness Intervention: Participants will receive a weekly home-based mindfulness intervention.~Participants also receive weekly symptom assessment phone interview."
200272|NCT01565980|O1|Outcome|Symptom Assessment|"weekly phone calls.~symptom assessment: attention control group"
200273|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants receive 6 weeks of the home-based mindfulness intervention, and weekly symptom assessment phone calls.~symptom assessment: attention control receives a weekly symptom assessment phone interview for 6 weeks.~Mindfulness Intervention: Participants will receive a weekly home-based mindfulness intervention, and symptom assessment phone interviews for 6 weeks."
200274|NCT01565980|O1|Outcome|Symptom Assessment|"6 weeks of symptom assessment phone calls.~symptom assessment: attention control receives a weekly symptom assessment phone interview for 6 weeks."
200275|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants receive 6 weekly sessions of a home delivered mindfulness intervention.~Participants receive weekly phone calls to assess symptoms."
200276|NCT01565980|O1|Outcome|Attention Control Group|"weekly phone calls.~symptom assessment interview."
200277|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants receive 6 weekly sessions of a home delivered mindfulness intervention.~Participants receive weekly phone calls to assess symptoms."
200278|NCT01565980|O1|Outcome|Attention Control Group|"weekly phone calls.~symptom assessment interview."
200279|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants receive 6 weekly sessions of a home delivered mindfulness intervention.~Participants receive weekly phone calls to assess symptoms."
200280|NCT01565980|O1|Outcome|Attention Control Group|"weekly phone calls.~symptom assessment interview."
200281|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants receive 6 weekly sessions of a home delivered mindfulness intervention.~Participants receive weekly phone calls to assess symptoms."
200282|NCT01565980|O1|Outcome|Attention Control Group|"weekly phone calls.~symptom assessment interview."
200283|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants receive 6 weekly sessions of a home delivered mindfulness intervention.~Participants receive weekly phone calls to assess symptoms."
200284|NCT01565980|O1|Outcome|Attention Control Group|"weekly phone calls.~symptom assessment interview."
200285|NCT01565980|E2|Reported Event|Mindfulness Intervention|"Participants will receive 6 weeks of home-based mindfulness intervention.~Mindfulness Intervention: Participants will receive a weekly home-based mindfulness intervention."
200286|NCT01565980|E1|Reported Event|Symptom Assessment|"weekly phone calls.~symptom assessment: attention control group"
200287|NCT01565941|B3|Baseline|Total|Total of all reporting groups
200288|NCT01565941|B2|Baseline|Tight Glycemic Control 2 (TGC-2)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL"
200289|NCT01565941|B1|Baseline|Tight Glycemic Control 1 (TGC-1)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL"
200290|NCT01565941|P2|Participant Flow|Tight Glycemic Control 2 (TGC-2)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL"
200291|NCT01565941|P1|Participant Flow|Tight Glycemic Control 1 (TGC-1)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL"
200292|NCT01565941|O2|Outcome|Tight Glycemic Control 2 (TGC-2)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL"
200293|NCT01565941|O1|Outcome|Tight Glycemic Control 1 (TGC-1)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL"
200294|NCT01565941|O2|Outcome|Tight Glycemic Control 2 (TGC-2)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL"
200295|NCT01565941|O1|Outcome|Tight Glycemic Control 1 (TGC-1)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL"
200296|NCT01565941|O2|Outcome|Tight Glycemic Control 2 (TGC-2)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL"
200355|NCT01565902|O4|Outcome|Matched Healthy Subjects – Mild|Treatment with a single oral dose of 0.25 mg BAF312
200297|NCT01565941|O1|Outcome|Tight Glycemic Control 1 (TGC-1)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL"
200298|NCT01565941|O2|Outcome|Tight Glycemic Control 2 (TGC-2)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL"
200299|NCT01565941|O1|Outcome|Tight Glycemic Control 1 (TGC-1)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL"
200300|NCT01565941|O2|Outcome|Tight Glycemic Control 2 (TGC-2)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL"
200301|NCT01565941|O1|Outcome|Tight Glycemic Control 1 (TGC-1)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL"
200302|NCT01565941|O2|Outcome|Tight Glycemic Control 2 (TGC-2)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL"
200303|NCT01565941|O1|Outcome|Tight Glycemic Control 1 (TGC-1)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL"
200304|NCT01565941|O2|Outcome|Tight Glycemic Control 2 (TGC-2)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL"
200305|NCT01565941|O1|Outcome|Tight Glycemic Control 1 (TGC-1)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL"
200306|NCT01565941|O2|Outcome|Tight Glycemic Control 2 (TGC-2)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL"
200307|NCT01565941|O1|Outcome|Tight Glycemic Control 1 (TGC-1)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL"
200308|NCT01565941|O2|Outcome|Tight Glycemic Control 2 (TGC-2)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL"
200309|NCT01565941|O1|Outcome|Tight Glycemic Control 1 (TGC-1)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL"
200310|NCT01565941|O2|Outcome|Tight Glycemic Control 2 (TGC-2)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL"
200311|NCT01565941|O1|Outcome|Tight Glycemic Control 1 (TGC-1)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL"
200312|NCT01565941|O2|Outcome|Tight Glycemic Control 2 (TGC-2)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL"
200313|NCT01565941|O1|Outcome|Tight Glycemic Control 1 (TGC-1)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL"
200314|NCT01565941|O2|Outcome|Tight Glycemic Control 2 (TGC-2)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL"
200315|NCT01565941|O1|Outcome|Tight Glycemic Control 1 (TGC-1)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL"
200316|NCT01565941|O2|Outcome|Tight Glycemic Control 2 (TGC-2)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL"
200356|NCT01565902|O3|Outcome|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
200317|NCT01565941|O1|Outcome|Tight Glycemic Control 1 (TGC-1)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL"
200318|NCT01565941|O2|Outcome|Tight Glycemic Control 2 (TGC-2)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL"
200319|NCT01565941|O1|Outcome|Tight Glycemic Control 1 (TGC-1)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL"
200320|NCT01565941|O2|Outcome|Tight Glycemic Control 2 (TGC-2)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL"
200321|NCT01565941|O1|Outcome|Tight Glycemic Control 1 (TGC-1)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL"
200322|NCT01565941|O2|Outcome|Tight Glycemic Control 2 (TGC-2)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL"
200323|NCT01565941|O1|Outcome|Tight Glycemic Control 1 (TGC-1)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL"
200324|NCT01565941|O2|Outcome|Tight Glycemic Control 2 (TGC-2)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL"
200325|NCT01565941|O1|Outcome|Tight Glycemic Control 1 (TGC-1)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL"
200326|NCT01565941|E2|Reported Event|Tight Glycemic Control 2 (TGC-2)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL"
200327|NCT01565941|E1|Reported Event|Tight Glycemic Control 1 (TGC-1)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL"
200328|NCT01565902|B5|Baseline|Total|Total of all reporting groups
200329|NCT01565902|B4|Baseline|Matched Healthy Subjects|Treatment with a single oral dose of 0.25 mg BAF312
200330|NCT01565902|B3|Baseline|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
200331|NCT01565902|B2|Baseline|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
200332|NCT01565902|B1|Baseline|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
200333|NCT01565902|P4|Participant Flow|Matched Healthy Subjects|Treatment with a single oral dose of 0.25 mg BAF312
200334|NCT01565902|P3|Participant Flow|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
200335|NCT01565902|P2|Participant Flow|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
200336|NCT01565902|P1|Participant Flow|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
200337|NCT01565902|O4|Outcome|Matched Healthy Subjects|Treatment with a single oral dose of 0.25 mg BAF312
200338|NCT01565902|O3|Outcome|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
200339|NCT01565902|O2|Outcome|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
200340|NCT01565902|O1|Outcome|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
200341|NCT01565902|O6|Outcome|Matched Healthy Subjects - Severe|Treatment with a single oral dose of 0.25 mg BAF312
200342|NCT01565902|O5|Outcome|Matched Healthy Subjects - Moderate|Treatment with a single oral dose of 0.25 mg BAF312
200343|NCT01565902|O4|Outcome|Matched Healthy Subjects – Mild|Treatment with a single oral dose of 0.25 mg BAF312
200344|NCT01565902|O3|Outcome|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
200345|NCT01565902|O2|Outcome|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
200346|NCT01565902|O1|Outcome|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
200347|NCT01565902|O6|Outcome|Matched Healthy Subjects - Severe|Treatment with a single oral dose of 0.25 mg BAF312
200348|NCT01565902|O5|Outcome|Matched Healthy Subjects - Moderate|Treatment with a single oral dose of 0.25 mg BAF312
200349|NCT01565902|O4|Outcome|Matched Healthy Subjects – Mild|Treatment with a single oral dose of 0.25 mg BAF312
200350|NCT01565902|O3|Outcome|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
200351|NCT01565902|O2|Outcome|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
200352|NCT01565902|O1|Outcome|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
200353|NCT01565902|O6|Outcome|Matched Healthy Subjects - Severe|Treatment with a single oral dose of 0.25 mg BAF312
200357|NCT01565902|O2|Outcome|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
200358|NCT01565902|O1|Outcome|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
200359|NCT01565902|E4|Reported Event|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
200360|NCT01565902|E3|Reported Event|Matched Healthy Subjects|Treatment with a single oral dose of 0.25 mg BAF312
200361|NCT01565902|E2|Reported Event|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
200362|NCT01565902|E1|Reported Event|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
200363|NCT01565889|B7|Baseline|Total|Total of all reporting groups
200364|NCT01565889|B6|Baseline|Part B: SOF+PEG+RBV|"SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.~This reporting group presents data for those participants who joined the study for Part B only."
200365|NCT01565889|B5|Baseline|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
200366|NCT01565889|B4|Baseline|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
200367|NCT01565889|B3|Baseline|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
200368|NCT01565889|B2|Baseline|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
200369|NCT01565889|B1|Baseline|Part A: SOF+EFV/FTC/TDF (Cohort 1)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
200370|NCT01565889|P6|Participant Flow|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + pegylated interferon alpha (PEG) 180 μg subcutaneous injection once weekly + weight-based ribavirin (RBV; 1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
200371|NCT01565889|P5|Participant Flow|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + raltegravir (RAL) 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
200372|NCT01565889|P4|Participant Flow|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + darunavir (DRV; 800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
200373|NCT01565889|P3|Participant Flow|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + atazanavir (ATV) 400 mg tablet boosted with ritonavir (RTV) 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
200374|NCT01565889|P2|Participant Flow|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + zidovudine (ZDV) 300 mg/lamivudine (3TC) 150 mg tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
200375|NCT01565889|P1|Participant Flow|Part A: SOF+EFV/FTC/TDF (Cohort 1)|Sofosbuvir (SOF; 1 × 400 mg tablet or 2 × 200 mg tablets) + efavirenz (EFV) 600 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
200376|NCT01565889|O6|Outcome|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
200377|NCT01565889|O5|Outcome|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
200378|NCT01565889|O4|Outcome|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
200379|NCT01565889|O3|Outcome|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
200380|NCT01565889|O2|Outcome|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
200381|NCT01565889|O1|Outcome|Part A: SOF+EFV/FTC/TDF (Cohort 1)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
200382|NCT01565889|O1|Outcome|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
200383|NCT01565889|O1|Outcome|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
200384|NCT01565889|O1|Outcome|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
200385|NCT01565889|O1|Outcome|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
200386|NCT01565889|O1|Outcome|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
200387|NCT01565889|O5|Outcome|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
200388|NCT01565889|O4|Outcome|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
200389|NCT01565889|O3|Outcome|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
200390|NCT01565889|O2|Outcome|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
200391|NCT01565889|O1|Outcome|Part A: SOF+EFV/FTC/TDF (Cohort 1)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
200392|NCT01565889|O5|Outcome|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
200393|NCT01565889|O4|Outcome|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
200394|NCT01565889|O3|Outcome|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
200395|NCT01565889|O2|Outcome|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
200396|NCT01565889|O1|Outcome|Part A: SOF+EFV/FTC/TDF (Cohort 1)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
200397|NCT01565889|E6|Reported Event|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
200398|NCT01565889|E5|Reported Event|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
200399|NCT01565889|E4|Reported Event|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
200400|NCT01565889|E3|Reported Event|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
200401|NCT01565889|E2|Reported Event|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
200402|NCT01565889|E1|Reported Event|Part A: SOF+EFV/FTC/TDF (Cohort 1)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
200403|NCT01565850|B3|Baseline|Total|Total of all reporting groups
200404|NCT01565850|B2|Baseline|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
200405|NCT01565850|B1|Baseline|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
200406|NCT01565850|P2|Participant Flow|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
200407|NCT01565850|P1|Participant Flow|D/C/F/TAF|Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) (800/150/200/10 mg) fixed-dose combination (FDC) tablet plus darunavir (DRV) placebo plus cobicistat (COBI) placebo plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo once daily
200408|NCT01565850|O2|Outcome|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
200409|NCT01565850|O1|Outcome|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
200410|NCT01565850|O2|Outcome|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
200411|NCT01565850|O1|Outcome|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
200412|NCT01565850|O2|Outcome|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
200413|NCT01565850|O1|Outcome|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
200414|NCT01565850|O2|Outcome|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
200415|NCT01565850|O1|Outcome|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
200416|NCT01565850|O2|Outcome|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
200417|NCT01565850|O1|Outcome|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
200418|NCT01565850|O2|Outcome|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
200419|NCT01565850|O1|Outcome|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
200420|NCT01565850|E2|Reported Event|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
200421|NCT01565850|E1|Reported Event|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
200422|NCT01565707|B5|Baseline|Total|Total of all reporting groups
200423|NCT01565707|B4|Baseline|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200424|NCT01565707|B3|Baseline|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
200425|NCT01565707|B2|Baseline|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200426|NCT01565707|B1|Baseline|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
200427|NCT01565707|P4|Participant Flow|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200428|NCT01565707|P3|Participant Flow|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
200429|NCT01565707|P2|Participant Flow|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200430|NCT01565707|P1|Participant Flow|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
200431|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200432|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
200433|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200434|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
200435|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200436|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
200437|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200438|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
200439|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
200440|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
200441|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
200442|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
200443|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
200444|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
200445|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
200446|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
200447|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
200448|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
200449|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
200450|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
200451|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
200452|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
200453|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
200454|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
200455|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
200456|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
200457|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
200458|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
200459|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
200460|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
200461|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
200462|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
200463|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
200464|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
200465|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
200466|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
200467|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
200468|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
200469|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
200470|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
200471|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
200472|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
200473|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
200474|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200475|NCT01565707|O1|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
200476|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200477|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
200478|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200479|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
200480|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200481|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
200482|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200483|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
200484|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200485|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
200486|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200487|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
200488|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200489|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
200490|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200491|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
200492|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200493|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
200494|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200495|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
200496|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200497|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
200498|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200499|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
200500|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200501|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
200502|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200503|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
200504|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200505|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
200506|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200507|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
200508|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200509|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
200510|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200511|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
200512|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200513|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
200514|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
200515|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
200516|NCT01565707|E4|Reported Event|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks.
200517|NCT01565707|E3|Reported Event|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo oral suspension once a day for 12 weeks.
200518|NCT01565707|E2|Reported Event|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks.
200519|NCT01565707|E1|Reported Event|Placebo Children|Children aged 5 to 11 years received matching placebo oral suspension once a day for 12 weeks.
200520|NCT01565616|B1|Baseline|Bone Marrow Transplant Recipients|Individuals receiving a bone marrow transplant at one of 10 study locations, between March 2012 and June, 2015.
200521|NCT01565616|P1|Participant Flow|Bone Marrow Transplant Recipients|Individuals with severe sickle cell disease receiving hematopoietic cell transplantation (HCT) from a human leukocyte antigen (HLA)-identical sibling donor or an unrelated HLA-matched donor
200522|NCT01565616|O1|Outcome|Bone Marrow Transplant Recipients|Individuals with severe sickle cell disease receiving hematopoietic cell transplantation (HCT) from a human leukocyte antigen (HLA)-identical sibling donor or an unrelated HLA-matched donor
200523|NCT01565616|O1|Outcome|Bone Marrow Transplant Recipients|Individuals with severe sickle cell disease receiving hematopoietic cell transplantation (HCT) from a human leukocyte antigen (HLA)-identical sibling donor or an unrelated HLA-matched donor
200524|NCT01565616|O1|Outcome|Bone Marrow Transplant Recipients|Individuals with severe sickle cell disease receiving hematopoietic cell transplantation (HCT) from a human leukocyte antigen (HLA)-identical sibling donor or an unrelated HLA-matched donor
200525|NCT01565616|O1|Outcome|Bone Marrow Transplant Recipients|Individuals with severe sickle cell disease receiving hematopoietic cell transplantation (HCT) from a human leukocyte antigen (HLA)-identical sibling donor or an unrelated HLA-matched donor
200526|NCT01565616|O1|Outcome|Bone Marrow Transplant Recipients|Individuals with severe sickle cell disease receiving hematopoietic cell transplantation (HCT) from a human leukocyte antigen (HLA)-identical sibling donor or an unrelated HLA-matched donor
200527|NCT01565616|O1|Outcome|Bone Marrow Transplant Recipients|Individuals with severe sickle cell disease receiving hematopoietic cell transplantation (HCT) from a human leukocyte antigen (HLA)-identical sibling donor or an unrelated HLA-matched donor
200528|NCT01565616|O1|Outcome|Bone Marrow Transplant Recipients|Individuals with severe sickle cell disease receiving hematopoietic cell transplantation (HCT) from a human leukocyte antigen (HLA)-identical sibling donor or an unrelated HLA-matched donor
200529|NCT01565616|O1|Outcome|Bone Marrow Transplant Recipients|Individuals with severe sickle cell disease receiving hematopoietic cell transplantation (HCT) from a human leukocyte antigen (HLA)-identical sibling donor or an unrelated HLA-matched donor
200530|NCT01565616|E1|Reported Event|Bone Marrow Transplant Recipients|Individuals with severe sickle cell disease receiving hematopoietic cell transplantation (HCT) from a human leukocyte antigen (HLA)-identical sibling donor or an unrelated HLA-matched donor
200531|NCT01565564|B3|Baseline|Total|Total of all reporting groups
200532|NCT01565564|B2|Baseline|The Shared Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
200533|NCT01565564|B1|Baseline|The Usual Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
200534|NCT01565564|P2|Participant Flow|The Usual Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
200535|NCT01565564|P1|Participant Flow|The Shared Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
200536|NCT01565564|O2|Outcome|The Shared Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
200537|NCT01565564|O1|Outcome|The Usual Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
200538|NCT01565564|O2|Outcome|The Shared Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
200539|NCT01565564|O1|Outcome|The Usual Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
200540|NCT01565564|E2|Reported Event|The Usual Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
200541|NCT01565564|E1|Reported Event|The Shared Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
200542|NCT01565551|B3|Baseline|Total|Total of all reporting groups
200543|NCT01565551|B2|Baseline|Late-Presenting TBI: Rehabilitation Center|"This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC).~N/A (Observational Study): No Interventions: Observational Study"
200544|NCT01565551|B1|Baseline|Early-Presenting TBI: Acute Sites|"This cohort of patients are studied after acute presentation within 24 hours of TBI to one of the three TRACK-TBI acute Level I Trauma Centers (SFGH, UPMC, UMCB).~N/A (Observational Study): No Interventions: Observational Study"
200545|NCT01565551|P2|Participant Flow|Late-Presenting TBI: Rehabilitation Center|"This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC).~N/A (Observational Study): No Interventions: Observational Study"
200546|NCT01565551|P1|Participant Flow|Early-Presenting TBI: Acute Sites|"This cohort of patients are studied after acute presentation within 24 hours of TBI to one of the three TRACK-TBI acute Level I Trauma Centers (SFGH, UPMC, UMCB).~N/A (Observational Study): No Interventions: Observational Study"
200547|NCT01565551|O2|Outcome|Late-Presenting TBI: Rehabilitation Center|"This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC).~N/A (Observational Study): No Interventions: Observational Study"
200548|NCT01565551|O1|Outcome|Early-Presenting TBI: Acute Sites|"This cohort of patients are studied after acute presentation within 24 hours of TBI to one of the three TRACK-TBI acute Level I Trauma Centers (SFGH, UPMC, UMCB).~N/A (Observational Study): No Interventions: Observational Study"
200549|NCT01565551|E2|Reported Event|Late-Presenting TBI: Rehabilitation Center|"This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC).~N/A (Observational Study): No Interventions: Observational Study"
200550|NCT01565551|E1|Reported Event|Early-Presenting TBI: Acute Sites|"This cohort of patients are studied after acute presentation within 24 hours of TBI to one of the three TRACK-TBI acute Level I Trauma Centers (SFGH, UPMC, UMCB).~N/A (Observational Study): No Interventions: Observational Study"
200551|NCT01565538|B3|Baseline|Total|Total of all reporting groups
200552|NCT01565538|B2|Baseline|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.~Pemetrexed: 500mg/m2 Given IV"
200553|NCT01565538|B1|Baseline|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.~Erlotinib: 150 mg Given orally"
200554|NCT01565538|P2|Participant Flow|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.~Pemetrexed: 500mg/m2 Given IV"
200555|NCT01565538|P1|Participant Flow|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.~Erlotinib: 150 mg Given orally"
200556|NCT01565538|O2|Outcome|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.~Pemetrexed: 500mg/m2 Given IV"
200557|NCT01565538|O1|Outcome|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.~Erlotinib: 150 mg Given orally"
200558|NCT01565538|O2|Outcome|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.~Pemetrexed: 500mg/m2 Given IV"
200559|NCT01565538|O1|Outcome|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.~Erlotinib: 150 mg Given orally"
200560|NCT01565538|O2|Outcome|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.~Pemetrexed: 500mg/m2 Given IV"
200561|NCT01565538|O1|Outcome|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.~Erlotinib: 150 mg Given orally"
200562|NCT01565538|E2|Reported Event|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.~Pemetrexed: 500mg/m2 Given IV"
200563|NCT01565538|E1|Reported Event|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.~Erlotinib: 150 mg Given orally"
200564|NCT01565382|B1|Baseline|A05 Florbetapir-PET Scans|Subjects who received a valid florbetapir-PET scan in Study A05 (NCT00702143)
200565|NCT01565382|P2|Participant Flow|Physicians|Private nuclear medicine physicians with no previous training in reading florbetapir scans.
200566|NCT01565382|P1|Participant Flow|A05 Florbetapir-PET Scans|Subjects who received a valid florbetapir-PET scan in Study A05 (NCT00702143)
200567|NCT01565382|O1|Outcome|A05 Florbetapir-PET Scans|Subjects who received a valid florbetapir-PET scan in Study A05 (NCT00702143)
200568|NCT01565382|O1|Outcome|A05 Florbetapir-PET Scans|Subjects who received a valid florbetapir-PET scan in Study A05(NCT00702143)
200569|NCT01565382|E1|Reported Event|A05 Florbetapir-PET Scans|Subjects who received a valid florbetapir-PET scan in Study A05 (NCT00702143)
200570|NCT01565369|B1|Baseline|All A07 Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07
200571|NCT01565369|P1|Participant Flow|All A07 Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07
200572|NCT01565369|O1|Outcome|All A07(NCT00857415) Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07(NCT00857415)
200573|NCT01565369|O1|Outcome|All A07 Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07(NCT00857415)
200574|NCT01565369|O1|Outcome|All A07(NCT00857415) Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07(NCT00857415)
200575|NCT01565369|E1|Reported Event|All A07 Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07
202152|NCT01559311|B3|Baseline|DDDR|Control Group – DDDR Standard Therapy
200576|NCT01565356|B1|Baseline|All Subject Scans|22 florbetapir-PET scans obtained in Study A01 and and 19 scans obtained in A03
200577|NCT01565356|P1|Participant Flow|All Subject Scans|22 florbetapir-PET scans obtained in Study A01 and and 19 scans obtained in A03
200578|NCT01565356|O1|Outcome|All Scans|22 florbetapir-PET scans obtained in Study A01(NCT01565291) and and 19 scans obtained in A03(NCT01565330)
200579|NCT01565356|O1|Outcome|All Scans|22 florbetapir-PET scans obtained in Study A01(NCT01565291) and and 19 scans obtained in A03(NCT01565330)
200580|NCT01565356|E1|Reported Event|All Subject Scans|22 florbetapir-PET scans obtained in Study A01 and and 19 scans obtained in A03
200581|NCT01565343|B4|Baseline|Total|Total of all reporting groups
200582|NCT01565343|B3|Baseline|Control Subjects|Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher
200583|NCT01565343|B2|Baseline|AD Subjects: Slow vs. Fast Bolus Group|Same inclusion criteria as AD subjects. The first injection given as a rapid bolus (< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration).
200584|NCT01565343|B1|Baseline|AD Subjects|Male or female subjects > 50 years old; probable AD according to NINCDS-ADRDA criteria; MMSE 10-24
200585|NCT01565343|P3|Participant Flow|Control Subjects|Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher
200586|NCT01565343|P2|Participant Flow|AD Subjects: Slow vs. Fast Bolus Group|Same inclusion criteria as AD subjects. The first injection given as a rapid bolus (< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration).
200587|NCT01565343|P1|Participant Flow|AD Subjects|Male or female subjects > 50 years old; probable AD according to NINCDS-ADRDA criteria; MMSE 10-24
200588|NCT01565343|O2|Outcome|Control Subjects|Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher
200589|NCT01565343|O1|Outcome|AD Subjects|Male or female subjects > 50 years old; probable Alzheimer's Disease) AD according to National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria; Mini-Mental State Examination (MMSE) 10-24
200590|NCT01565343|E3|Reported Event|Control Subjects|Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher
200591|NCT01565343|E2|Reported Event|AD Subjects: Slow vs. Fast Bolus Group|Same inclusion criteria as AD subjects. The first injection given as a rapid bolus (< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration).
200592|NCT01565343|E1|Reported Event|AD Subjects|Male or female subjects > 50 years old; probable AD according to NINCDS-ADRDA criteria; MMSE 10-24
200593|NCT01565330|B5|Baseline|Total|Total of all reporting groups
200594|NCT01565330|B4|Baseline|370 MBq (10 mCi) Control Group|Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
200595|NCT01565330|B3|Baseline|370 MBq (10 mCi) AD Group|Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
200596|NCT01565330|B2|Baseline|111 MBq (3 mCi) Control Group|Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
200597|NCT01565330|B1|Baseline|111 MBq (3 mCi) AD Group|Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
200598|NCT01565330|P4|Participant Flow|370 MBq (10 mCi) Control Group|Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
200599|NCT01565330|P3|Participant Flow|370 MBq (10 mCi) AD Group|Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
200600|NCT01565330|P2|Participant Flow|111 MBq (3 mCi) Control Group|Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
200601|NCT01565330|P1|Participant Flow|111 MBq (3 mCi) AD Group|Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
200602|NCT01565330|O4|Outcome|370 MBq (10 mCi) Control Group|Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
200603|NCT01565330|O3|Outcome|370 MBq (10 mCi) AD Group|Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
200604|NCT01565330|O2|Outcome|111 MBq (3 mCi) Control Group|Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
200605|NCT01565330|O1|Outcome|111 MBq (3 mCi) AD Group|Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
200606|NCT01565330|O4|Outcome|370 MBq (10 mCi) Control Group|Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
200607|NCT01565330|O3|Outcome|370 MBq (10 mCi) AD Group|Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
200608|NCT01565330|O2|Outcome|111 MBq (3 mCi) Control Group|Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
200609|NCT01565330|O1|Outcome|111 MBq (3 mCi) AD Group|Subjects with Alzheimer's Disease (AD) who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
200610|NCT01565330|E4|Reported Event|370 MBq (10 mCi) Control Group|Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
200611|NCT01565330|E3|Reported Event|370 MBq (10 mCi) AD Group|Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
200612|NCT01565330|E2|Reported Event|111 MBq (3 mCi) Control Group|Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
200613|NCT01565330|E1|Reported Event|111 MBq (3 mCi) AD Group|Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
200614|NCT01565291|B3|Baseline|Total|Total of all reporting groups
200615|NCT01565291|B2|Baseline|Healthy Elderly Subjects|Cognitively normal with MMSE of 29 or higher; age 50 years or older
200616|NCT01565291|B1|Baseline|Subjects With AD|Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24)
200617|NCT01565291|P2|Participant Flow|Healthy Elderly Subjects|Cognitively normal with MMSE of 29 or higher; age 50 years or older
200618|NCT01565291|P1|Participant Flow|Subjects With AD|Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24)
200619|NCT01565291|O2|Outcome|Healthy Elderly Subjects|Cognitively normal with MMSE of 29 or higher; age 50 years or older
200620|NCT01565291|O1|Outcome|Subjects With AD|Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24)
200621|NCT01565291|O2|Outcome|Healthy Elderly Subjects|Cognitively normal with MMSE of 29 or higher; age 50 years or older
200622|NCT01565291|O1|Outcome|Subjects With AD|Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24)
200623|NCT01565291|E2|Reported Event|Healthy Elderly Subjects|Cognitively normal with MMSE of 29 or higher; age 50 years or older
200624|NCT01565291|E1|Reported Event|Subjects With AD|Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24)
200625|NCT01565148|B5|Baseline|Total|Total of all reporting groups
200626|NCT01565148|B4|Baseline|Group 4|Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
200627|NCT01565148|B3|Baseline|Group 3|iCo-007 350 mcg Plus Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
200628|NCT01565148|B2|Baseline|Group 2|iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
200629|NCT01565148|B1|Baseline|Group 1|iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
200630|NCT01565148|P4|Participant Flow|Ranibizumab and iCo-007 350 mcg|Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
200631|NCT01565148|P3|Participant Flow|iCo-007 350 mcg and Laser|iCo-007 350 mcg and Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
200632|NCT01565148|P2|Participant Flow|iCo-007 700 mcg|iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
200633|NCT01565148|P1|Participant Flow|iCo-007 350 mcg|iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
200634|NCT01565148|O4|Outcome|Ranibizumab and iCo-007 350 mcg|Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
200635|NCT01565148|O3|Outcome|iCo-007 350 mcg and Laser|iCo-007 350 mcg and Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
200636|NCT01565148|O2|Outcome|iCo-007 700 mcg|iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
200637|NCT01565148|O1|Outcome|iCo-007 350 mcg|iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
200638|NCT01565148|O4|Outcome|Ranibizumab and iCo-007 350 mcg|Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
200639|NCT01565148|O3|Outcome|iCo-007 350 mcg and Laser|iCo-007 350 mcg and Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
200640|NCT01565148|O2|Outcome|iCo-007 700 mcg|iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
200641|NCT01565148|O1|Outcome|iCo-007 350 mcg|iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
200642|NCT01565148|O4|Outcome|Ranibizumab and iCo-007 350 mcg|Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
200643|NCT01565148|O3|Outcome|iCo-007 350 mcg and Laser|iCo-007 350 mcg and Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
200644|NCT01565148|O2|Outcome|iCo-007 700 mcg|iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
200645|NCT01565148|O1|Outcome|iCo-007 350 mcg|iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
200646|NCT01565148|O4|Outcome|Group 4|Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
200647|NCT01565148|O3|Outcome|Group 3|iCo-007 350 mcg Plus Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
200648|NCT01565148|O2|Outcome|Group 2|iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
200649|NCT01565148|O1|Outcome|Group 1|iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
200650|NCT01565148|O4|Outcome|Ranibizumab and iCo-007 350 mcg|Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
200651|NCT01565148|O3|Outcome|iCo-007 350 mcg and Laser|iCo-007 350 mcg and Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
200652|NCT01565148|O2|Outcome|iCo-007 700 mcg|iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
200653|NCT01565148|O1|Outcome|iCo-007 350 mcg|iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
200654|NCT01565148|O4|Outcome|Group 4|Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
200655|NCT01565148|O3|Outcome|Group 3|iCo-007 350 mcg Plus Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
200656|NCT01565148|O2|Outcome|Group 2|iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
200657|NCT01565148|O1|Outcome|Group 1|iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
200658|NCT01565148|O4|Outcome|Group 4|Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
200659|NCT01565148|O3|Outcome|Group 3|iCo-007 350 mcg Plus Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
200660|NCT01565148|O2|Outcome|Group 2|iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
200661|NCT01565148|O1|Outcome|Group 1|iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
200662|NCT01565148|E4|Reported Event|Group 4|Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
200663|NCT01565148|E3|Reported Event|Group 3|iCo-007 350 mcg Plus Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
200664|NCT01565148|E2|Reported Event|Group 2|iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
200665|NCT01565148|E1|Reported Event|Group 1|iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
200666|NCT01565083|B3|Baseline|Total|Total of all reporting groups
200667|NCT01565083|B2|Baseline|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200668|NCT01565083|B1|Baseline|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200669|NCT01565083|P2|Participant Flow|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200708|NCT01564862|P2|Participant Flow|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
200709|NCT01564862|P1|Participant Flow|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
200670|NCT01565083|P1|Participant Flow|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab intravenous (IV) infusion at a loading dose of 840 milligrams (mg) on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg per kilogram (mg/kg) on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg per meter-squared (mg/m^2) on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200671|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200672|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200673|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200674|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200675|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200676|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200677|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200678|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200710|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
200711|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
200679|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200680|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200681|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200682|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200683|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200684|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200685|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200686|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200687|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200712|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
200713|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
200688|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200689|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200690|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200691|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200692|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200693|NCT01565083|E2|Reported Event|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200694|NCT01565083|E1|Reported Event|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
200695|NCT01564953|B1|Baseline|Serum Vitamin D, Magnesium and Calcium Deficient Groups|Participants were distributed into wether they were serum vitamin D, magnesium and calcium sufficiency or deficiency.
200696|NCT01564953|P1|Participant Flow|Serum Vitamin D, Magnesium and Calcium Deficient Groups|Participants were distributed into wether they were serum vitamin D, magnesium and calcium sufficiency or deficiency.
200697|NCT01564953|O1|Outcome|Quality of Life|Quality of life measured by Chronic Obstructive Pulmonary Disease Assesment Test
200698|NCT01564953|O1|Outcome|Serum Calcium|Serum ionized calcium, in mmol/L
200699|NCT01564953|O1|Outcome|Serum Magnesium|Serum magnesium in plasma, in mmol/L
200700|NCT01564953|O1|Outcome|Lung Function|lung function measured as forced expiratory volumes in 1 second.
200701|NCT01564953|O1|Outcome|Serum Vitamin D|Participants' serum vitamin D
200702|NCT01564953|E1|Reported Event||Adverse Events were not collected for the 143 participants
200703|NCT01564862|B4|Baseline|Total|Total of all reporting groups
200704|NCT01564862|B3|Baseline|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
200705|NCT01564862|B2|Baseline|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
200706|NCT01564862|B1|Baseline|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
200707|NCT01564862|P3|Participant Flow|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
200714|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
200715|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
200716|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
200717|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
200718|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
200719|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
200720|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
200721|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
200722|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
200723|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
200724|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
200725|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
200726|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
200727|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
200728|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
200729|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
200730|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
200731|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
200732|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
200733|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
200734|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
200735|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
200736|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
200737|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
200738|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
200739|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
200740|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
200741|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
200742|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
200743|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
200744|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
200745|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
200746|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
200747|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
200748|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
200749|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
200750|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
200751|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
200752|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
200753|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
200754|NCT01564862|E3|Reported Event|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
200755|NCT01564862|E2|Reported Event|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
200756|NCT01564862|E1|Reported Event|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
200757|NCT01564784|B3|Baseline|Total|Total of all reporting groups
200758|NCT01564784|B2|Baseline|Defined Investigator’s Choice of Chemotherapy|Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator’s choice.
200759|NCT01564784|B1|Baseline|Inotuzumab Ozogamicin|Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m^2 (for a total cycle dose of 1.5 mg/m^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
200760|NCT01564784|P2|Participant Flow|Defined Investigator’s Choice of Chemotherapy|Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator’s choice.
200761|NCT01564784|P1|Participant Flow|Inotuzumab Ozogamicin|Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m^2 (for a total cycle dose of 1.5 mg/m^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
200762|NCT01564784|O2|Outcome|Defined Investigator’s Choice of Chemotherapy|Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator’s choice.
200763|NCT01564784|O1|Outcome|Inotuzumab Ozogamicin|Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m^2 (for a total cycle dose of 1.5 mg/m^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
200764|NCT01564784|O2|Outcome|Defined Investigator’s Choice of Chemotherapy|Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator’s choice.
200765|NCT01564784|O1|Outcome|Inotuzumab Ozogamicin|Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m^2 (for a total cycle dose of 1.5 mg/m^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
200766|NCT01564784|O2|Outcome|Defined Investigator’s Choice of Chemotherapy|Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator’s choice.
200767|NCT01564784|O1|Outcome|Inotuzumab Ozogamicin|Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m^2 (for a total cycle dose of 1.5 mg/m^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
200768|NCT01564784|O2|Outcome|Defined Investigator’s Choice of Chemotherapy|Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator’s choice.
200888|NCT01564407|O3|Outcome|Admin Day 0 and 28|5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ day 28
200769|NCT01564784|O1|Outcome|Inotuzumab Ozogamicin|Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m^2 (for a total cycle dose of 1.5 mg/m^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
200770|NCT01564784|O1|Outcome|Inotuzumab Ozogamicin|Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m^2 (for a total cycle dose of 1.5 mg/m^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
200771|NCT01564784|O2|Outcome|Defined Investigator’s Choice of Chemotherapy|Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator’s choice.
200772|NCT01564784|O1|Outcome|Inotuzumab Ozogamicin|Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m^2 (for a total cycle dose of 1.5 mg/m^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
200773|NCT01564784|O2|Outcome|Defined Investigator’s Choice of Chemotherapy|Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator’s choice.
200774|NCT01564784|O1|Outcome|Inotuzumab Ozogamicin|Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m^2 (for a total cycle dose of 1.5 mg/m^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
200775|NCT01564784|O2|Outcome|Defined Investigator’s Choice of Chemotherapy|Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator’s choice.
200776|NCT01564784|O1|Outcome|Inotuzumab Ozogamicin|Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m^2 (for a total cycle dose of 1.5 mg/m^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
200777|NCT01564784|O2|Outcome|Defined Investigator’s Choice of Chemotherapy|Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator’s choice.
200778|NCT01564784|O1|Outcome|Inotuzumab Ozogamicin|Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m^2 (for a total cycle dose of 1.5 mg/m^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
200779|NCT01564784|O2|Outcome|Defined Investigator’s Choice of Chemotherapy|Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator’s choice.
200820|NCT01564693|P2|Participant Flow|NON-ANOREXIC CANCER PATIENTS|According to the protocol, we evaluated 4 patients with lung cancer who met the inclusion criteria and were enrolled in the study. According to the protocol, the absence of anorexia was assessed by appetite assessment tools.
200889|NCT01564407|O2|Outcome|Single Admin Day 28|5 million cells/ cm² , single administration at day 28
200890|NCT01564407|O1|Outcome|Single Admin Day 0|5 million cells / cm² , single administration at Day 0
200780|NCT01564784|O1|Outcome|Inotuzumab Ozogamicin|Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m^2 (for a total cycle dose of 1.5 mg/m^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
200781|NCT01564784|O2|Outcome|Defined Investigator’s Choice of Chemotherapy|Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator’s choice.
200782|NCT01564784|O1|Outcome|Inotuzumab Ozogamicin|Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m^2 (for a total cycle dose of 1.5 mg/m^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
200783|NCT01564784|O2|Outcome|Defined Investigator’s Choice of Chemotherapy|Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator’s choice.
200784|NCT01564784|O1|Outcome|Inotuzumab Ozogamicin|Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m^2 (for a total cycle dose of 1.5 mg/m^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
200785|NCT01564784|E2|Reported Event|Defined Investigator’s Choice of Chemotherapy|Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator’s choice.
200786|NCT01564784|E1|Reported Event|Inotuzumab Ozogamicin|Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m^2 (for a total cycle dose of 1.5 mg/m^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
200787|NCT01564758|B1|Baseline|Linezolid|Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator’s discretion.
200788|NCT01564758|P1|Participant Flow|Linezolid|Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator’s discretion.
200789|NCT01564758|O1|Outcome|Linezolid|Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator’s discretion.
200790|NCT01564758|O1|Outcome|Linezolid|Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator’s discretion.
200791|NCT01564758|E1|Reported Event|Linezolid|Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator’s discretion.
200792|NCT01564732|B3|Baseline|Total|Total of all reporting groups
200793|NCT01564732|B2|Baseline|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
200821|NCT01564693|P1|Participant Flow|ANOREXIC CANCER PATIENTS|We evaluated 9 patients with lung cancer who met the inclusion criteria and were enrolled in the study. According to the protocol, the presence of anorexia was assessed by appetite assessment tools.
200822|NCT01564693|O3|Outcome|CONTROL GROUP|Healthy subjects were studied regarding BOLD signal activity by fMRI
200823|NCT01564693|O2|Outcome|NON-ANOREXIC CANCER PATIENTS|Patients revealed as non-anorexic were studied regarding BOLD signal activity by fMRI
200794|NCT01564732|B1|Baseline|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
200795|NCT01564732|P2|Participant Flow|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
200796|NCT01564732|P1|Participant Flow|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
200797|NCT01564732|O2|Outcome|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
200798|NCT01564732|O1|Outcome|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
200799|NCT01564732|O2|Outcome|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
200800|NCT01564732|O1|Outcome|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
200801|NCT01564732|O2|Outcome|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
200802|NCT01564732|O1|Outcome|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
200824|NCT01564693|O1|Outcome|ANOREXIC CANCER PATIENTS|Patients revealed as anorexic were studied regarding BOLD signal activity by fMRI
200825|NCT01564693|E3|Reported Event|CONTROL GROUP|Two volunteers were studied by fMRI before and after administration of a standard meal. The presence of serious adverse events (i.e., allergy, claustrophobia) were investigated. The presence of nausea and vomiting after the intake of the standard meal was also investigated.
200891|NCT01564407|O5|Outcome|Vehicle Only|Vehicle only (0.5 ml of solution)
200892|NCT01564407|O4|Outcome|No Injection|Safety cohort. 4 subjects received empty control. No injection
200803|NCT01564732|O2|Outcome|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
200804|NCT01564732|O1|Outcome|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
200805|NCT01564732|O2|Outcome|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
200806|NCT01564732|O1|Outcome|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
200807|NCT01564732|O2|Outcome|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
200808|NCT01564732|O1|Outcome|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
200809|NCT01564732|E2|Reported Event|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
200810|NCT01564732|E1|Reported Event|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
200811|NCT01564706|B1|Baseline|Healthy Volunteers|Single i.v. administration of approximately 10mCi 18F-AV-45
200812|NCT01564706|P1|Participant Flow|Healthy Volunteers|Single i.v. administration of approximately 10mCi 18F-AV-45
200813|NCT01564706|O1|Outcome|Healthy Volunteers|Single i.v. administration of approximately 10mCi 18F-AV-45
200814|NCT01564706|E1|Reported Event|Healthy Volunteers|Single i.v. administration of approximately 10mCi 18F-AV-45
200815|NCT01564693|B4|Baseline|Total|Total of all reporting groups
200816|NCT01564693|B3|Baseline|CONTROL GROUP|These were healthy subjects. 1 MD working at the Oncology Dept. , 1 family member of one of the patients enrolled.
200817|NCT01564693|B2|Baseline|NON-ANOREXIC CANCER PATIENTS|Based on the anorexia instruments that we used, we considered these patients as non-anorexic
200818|NCT01564693|B1|Baseline|ANOREXIC CANCER PATIENTS|Based on the anorexia instruments that we used, we considered these patients as anorexic.
200819|NCT01564693|P3|Participant Flow|CONTROL GROUP|Two healthy volunteers were evaluated and included in the study as controls. Their appetite was normal, as assessed by appetite measurement tools.
200886|NCT01564407|O5|Outcome|Vehicle Only|Vehicle only (0.5 ml of solution)
200826|NCT01564693|E2|Reported Event|NON-ANOREXIC CANCER PATIENTS|Four patients were studied by fMRI before and after administration of a standard meal. The presence of serious adverse events (i.e., allergy, claustrophobia) were investigated. The presence of nausea and vomiting after the intake of the standard meal was also investigated.
200827|NCT01564693|E1|Reported Event|ANOREXIC CANCER PATIENTS|Nine patients were studied by fMRI before and after administration of a standard meal. The presence of serious adverse events (i.e., allergy, claustrophobia) were investigated. The presence of nausea and vomiting after the intake of the standard meal was also investigated.
200828|NCT01564537|B3|Baseline|Total|Total of all reporting groups
200829|NCT01564537|B2|Baseline|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
200830|NCT01564537|B1|Baseline|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
200831|NCT01564537|P2|Participant Flow|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
200832|NCT01564537|P1|Participant Flow|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to end of treatment (EOT) projected at 80 months.
200833|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
200834|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
200835|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
200836|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
200837|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
200838|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
200839|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
200840|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
200841|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
200842|NCT01564537|O1|Outcome|Ixazomib + Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
200843|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
200844|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
200887|NCT01564407|O4|Outcome|No Injection|Safety cohort. 4 subjects received empty control. No injection
200845|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
200846|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
200847|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
200848|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
200849|NCT01564537|E2|Reported Event|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
200850|NCT01564537|E1|Reported Event|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity up to EOT projected at 80 months.
200851|NCT01564459|B4|Baseline|Total|Total of all reporting groups
200852|NCT01564459|B3|Baseline|MK-6096 10 mg→Placebo|Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive placebo during double-blind treatment period.
200853|NCT01564459|B2|Baseline|MK-6096 10 mg→MK-6096 10 mg|Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive MK-6096 10 mg during double-blind treatment period
200854|NCT01564459|B1|Baseline|MK-6096 10 mg→No Treatment|Participants who received MK-6096 10 mg during run-in and did not continue to double-blind treatment period.
200855|NCT01564459|P3|Participant Flow|MK-6096 10 mg→Placebo|Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive placebo during double-blind treatment period.
200856|NCT01564459|P2|Participant Flow|MK-6096 10 mg→MK-6096 10 mg|Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive MK-6096 10 mg during double-blind treatment period.
200857|NCT01564459|P1|Participant Flow|MK-6096 10 mg→No Treatment|Participants who received MK-6096 10 mg during run-in and did not continue to double-blind treatment period.
200858|NCT01564459|O3|Outcome|Placebo- Double-Blind Period|Participants who received placebo during double-blind treatment period
200859|NCT01564459|O2|Outcome|MK-6096 10 Mg-Double Blind Period|Participants who received MK-6096 during double blind treatment period
200860|NCT01564459|O1|Outcome|MK-6096 10 mg - Run-in Period|Participants who received MK-6096 10 mg during run-in period
200861|NCT01564459|O3|Outcome|Placebo- Double-Blind Period|Participants who received placebo during double-blind treatment period
200862|NCT01564459|O2|Outcome|MK-6096 10 Mg-Double Blind Period|Participants who received MK-6096 during double blind treatment period
200863|NCT01564459|O1|Outcome|MK-6096 10 mg - Run-in Period|Participants who received MK-6096 10 mg during run-in period
200864|NCT01564459|O2|Outcome|Placebo|Matching compressed tablets, taken once daily at bedtime for 14 days.
200865|NCT01564459|O1|Outcome|MK-6096|MK-6096 10 mg compressed tablets, taken once daily at bedtime for 14 days.
200866|NCT01564459|O2|Outcome|Placebo|Matching compressed tablets, taken once daily at bedtime for 14 days.
200867|NCT01564459|O1|Outcome|MK-6096|MK-6096 10 mg compressed tablets, taken once daily at bedtime for 14 days.
200868|NCT01564459|O2|Outcome|Placebo|Matching compressed tablets, taken once daily at bedtime for 14 days.
200869|NCT01564459|O1|Outcome|MK-6096|MK-6096 10 mg compressed tablets, taken once daily at bedtime for 14 days.
200870|NCT01564459|O2|Outcome|Placebo|Matching compressed tablets, taken once daily at bedtime for 14 days.
200871|NCT01564459|O1|Outcome|MK-6096|Participants who were randomly assigned to receive MK-6096 10 mg during double blind treatment period.
200872|NCT01564459|E3|Reported Event|Placebo- Double-Blind Period|Participants who received placebo during double-blind treatment period
200873|NCT01564459|E2|Reported Event|MK-6096 10 Mg-Double Blind Period|Participants who received MK-6096 during double blind treatment period
200874|NCT01564459|E1|Reported Event|MK-6096 10 mg - Run-in Period|Participants who received MK-6096 10 mg during run-in period
200875|NCT01564407|B6|Baseline|Total|Total of all reporting groups
200876|NCT01564407|B5|Baseline|Admin Day 0 and 28|5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ day 28
200877|NCT01564407|B4|Baseline|Single Admin Day 28|5 million cells/ cm² , single administration at day 28
200878|NCT01564407|B3|Baseline|Single Admin Day 0|5 million cells / cm² , single administration at Day 0
200879|NCT01564407|B2|Baseline|Vehicle Only|Vehicle only (0.5 ml of HypoThermosol solution)
200880|NCT01564407|B1|Baseline|No Injection|Empty safety control, no injection
200881|NCT01564407|P5|Participant Flow|Admin Drug Day 0 and 28|Single administration day 0 and 28
200882|NCT01564407|P4|Participant Flow|Single Admin Drug Day 28|Single administration on Day 28
200883|NCT01564407|P3|Participant Flow|Single Admin Drug Day 0|Single administration of study drug on day 0
200884|NCT01564407|P2|Participant Flow|Vehicle Only|Vehicle only (0.5 ml of solution)
200885|NCT01564407|P1|Participant Flow|No Injection|Safety cohort. 4 subjects received empty control. No injection
200893|NCT01564407|O3|Outcome|Admin Day 0 and 28|5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ day 28
200894|NCT01564407|O2|Outcome|Single Admin Day 28|5 million cells/ cm² , single administration at day 28
200895|NCT01564407|O1|Outcome|Single Admin Day 0|5 million cells / cm² , single administration at Day 0
200896|NCT01564407|O5|Outcome|Vehicle Only|Vehicle only (0.5 ml of solution)
200897|NCT01564407|O4|Outcome|No Injection|Safety cohort. 4 subjects received empty control. No injection
200898|NCT01564407|O3|Outcome|Admin Day 0 and 28|5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ day 28
200899|NCT01564407|O2|Outcome|Single Admin Day 28|5 million cells/ cm² , single administration at day 28
200900|NCT01564407|O1|Outcome|Single Admin Day 0|5 million cells / cm² , single administration at Day 0
200901|NCT01564407|O5|Outcome|Vehicle Only|Vehicle only (0.5 ml of HypoThermosol solution)
200902|NCT01564407|O4|Outcome|No Injection|Empty safety control, no injection
200903|NCT01564407|O3|Outcome|Admin Day 0 and 28|5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ day 28
200904|NCT01564407|O2|Outcome|Single Admin Day 28|5 million cells/ cm² , single administration at day 28
200905|NCT01564407|O1|Outcome|Single Admin Day 0|5 million cells / cm² , single administration at Day 0
200906|NCT01564407|O4|Outcome|Single Admin Drug Day 28|Single administration of study drug on day 28
200907|NCT01564407|O3|Outcome|Single Admin Drug Day 0|Single administration of study drug on day 0
200908|NCT01564407|O2|Outcome|Vehicle Only|Vehicle only (0.5 ml of solution)
200909|NCT01564407|O1|Outcome|no Injection|Safety cohort. 4 subjects received empty control. No injection
200910|NCT01564407|O4|Outcome|Single Admin Drug Day 28|Single administration on Day 28
200911|NCT01564407|O3|Outcome|Single Admin Drug Day 0|Single administration of study drug on day 0
200912|NCT01564407|O2|Outcome|Vehicle Only|Vehicle only (0.5 ml of solution)
200913|NCT01564407|O1|Outcome|No Injection|Safety cohort. 4 subjects received empty control. No injection
200914|NCT01564407|O4|Outcome|Single Admin Drug Day 28|Single administration of study drug on day 28
200915|NCT01564407|O3|Outcome|Single Admin Drug Day 0|Single administration of study drug on day 0
200916|NCT01564407|O2|Outcome|Vehicle Only|Vehicle only (0.5 ml of solution)
200917|NCT01564407|O1|Outcome|no Injection|Empty control no injection
200918|NCT01564407|E5|Reported Event|no Injection|Adverse events in each cohort included pain, swelling and redness at the site of injection that resolved within 8 hours of treatment
200919|NCT01564407|E4|Reported Event|Admin Day 0 and 28|Adverse events in each cohort included pain, swelling and redness at the site of injection that resolved within 8 hours of treatment
200920|NCT01564407|E3|Reported Event|Single Admin Day 28|Adverse events in each cohort included pain, swelling and redness at the site of injection that resolved within 8 hours of treatment
200921|NCT01564407|E2|Reported Event|Single Admin Day 0|Adverse events in each cohort included pain, swelling and redness at the site of injection that resolved within 8 hours of treatment
200922|NCT01564407|E1|Reported Event|Vehicle Only,|Adverse events in each cohort included pain, swelling and redness at the site of injection that resolved within 8 hours of treatment
200923|NCT01564394|B3|Baseline|Total|Total of all reporting groups
200924|NCT01564394|B2|Baseline|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.~Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
200925|NCT01564394|B1|Baseline|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.~Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
200926|NCT01564394|P2|Participant Flow|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.~Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
200927|NCT01564394|P1|Participant Flow|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.~Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
200939|NCT01564277|B2|Baseline|Arm II (3 mg Rasburicase)|"Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.~rasburicase: Given IV~allopurinol: Given PO"
200940|NCT01564277|B1|Baseline|Arm I (1.5mg Rasburicase)|"Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.~rasburicase: Given IV~allopurinol: Given PO"
200928|NCT01564394|O2|Outcome|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.~Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
200929|NCT01564394|O1|Outcome|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.~Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
200930|NCT01564394|O2|Outcome|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.~Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
200931|NCT01564394|O1|Outcome|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.~Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
200932|NCT01564394|O2|Outcome|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.~Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
200933|NCT01564394|O1|Outcome|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.~Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
200934|NCT01564394|O2|Outcome|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.~Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
200935|NCT01564394|O1|Outcome|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.~Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
200936|NCT01564394|E2|Reported Event|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.~Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
200937|NCT01564394|E1|Reported Event|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.~Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
200938|NCT01564277|B3|Baseline|Total|Total of all reporting groups
200997|NCT01563536|B3|Baseline|Total|Total of all reporting groups
200941|NCT01564277|P2|Participant Flow|Arm II (3 mg Rasburicase)|"Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.~rasburicase: Given IV~allopurinol: Given PO"
200942|NCT01564277|P1|Participant Flow|Arm I (1.5mg Rasburicase)|"Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.~rasburicase: Given IV~allopurinol: Given PO"
200943|NCT01564277|O2|Outcome|Arm II (3 mg Rasburicase)|"Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.~rasburicase: Given IV~allopurinol: Given PO"
200944|NCT01564277|O1|Outcome|Arm I (1.5mg Rasburicase)|"Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.~rasburicase: Given IV~allopurinol: Given PO"
200945|NCT01564277|O2|Outcome|Arm II (3 mg Rasburicase)|"Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.~rasburicase: Given IV~allopurinol: Given PO"
200946|NCT01564277|O1|Outcome|Arm I (1.5mg Rasburicase)|"Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.~rasburicase: Given IV~allopurinol: Given PO"
200947|NCT01564277|O2|Outcome|Arm II (3 mg Rasburicase)|"Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.~rasburicase: Given IV~allopurinol: Given PO"
200948|NCT01564277|O1|Outcome|Arm I (1.5mg Rasburicase)|"Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.~rasburicase: Given IV~allopurinol: Given PO"
200949|NCT01564277|O2|Outcome|Arm II (3 mg Rasburicase)|"Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.~rasburicase: Given IV~allopurinol: Given PO"
200950|NCT01564277|O1|Outcome|Arm I (1.5mg Rasburicase)|"Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.~rasburicase: Given IV~allopurinol: Given PO"
200951|NCT01564277|O2|Outcome|Arm II (3 mg Rasburicase)|"Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.~rasburicase: Given IV~allopurinol: Given PO"
200952|NCT01564277|O1|Outcome|Arm I (1.5mg Rasburicase)|"Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.~rasburicase: Given IV~allopurinol: Given PO"
200953|NCT01564277|O2|Outcome|Arm II (3 mg Rasburicase)|"Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.~rasburicase: Given IV~allopurinol: Given PO"
200954|NCT01564277|O1|Outcome|Arm I (1.5mg Rasburicase)|"Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.~rasburicase: Given IV~allopurinol: Given PO"
200955|NCT01564277|E2|Reported Event|Arm II (3 mg Rasburicase)|"Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.~rasburicase: Given IV~allopurinol: Given PO"
200956|NCT01564277|E1|Reported Event|Arm I (1.5mg Rasburicase)|"Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.~rasburicase: Given IV~allopurinol: Given PO"
200957|NCT01563978|B3|Baseline|Total|Total of all reporting groups
200958|NCT01563978|B2|Baseline|PLACEBO|Oral treatment
200959|NCT01563978|B1|Baseline|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
200960|NCT01563978|P2|Participant Flow|PLACEBO|Oral treatment
200961|NCT01563978|P1|Participant Flow|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
200962|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
200963|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
200964|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
200965|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
200966|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
200967|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
200968|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
200969|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
200970|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
200971|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
200972|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
200973|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
200974|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
200975|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
200976|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
200977|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
200978|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
200979|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
200980|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
200981|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
200982|NCT01563978|E2|Reported Event|PLACEBO|
200983|NCT01563978|E1|Reported Event|FOSTA 100 MG BID|
200984|NCT01563913|B3|Baseline|Total|Total of all reporting groups
200985|NCT01563913|B2|Baseline|Placebo:|Placebo: Sugar Pill, taken for 1.5 years
200986|NCT01563913|B1|Baseline|Docosahexaenoic Acid|Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years
200987|NCT01563913|P2|Participant Flow|Placebo|Placebo: Sugar Pill, taken for 1.5 years
200988|NCT01563913|P1|Participant Flow|Docosahexaenoic Acid (DHA)|Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years
200989|NCT01563913|O2|Outcome|Placebo:|Placebo: Sugar Pill, taken for 1.5 years
200990|NCT01563913|O1|Outcome|Docosahexaenoic Acid|Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years
200991|NCT01563913|O2|Outcome|Placebo:|Placebo: Sugar Pill, taken for 1.5 years
200992|NCT01563913|O1|Outcome|Docosahexaenoic Acid|Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years
200993|NCT01563913|O2|Outcome|Placebo:|Placebo: Sugar Pill, taken for 1.5 years
200994|NCT01563913|O1|Outcome|Docosahexaenoic Acid|Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years
200995|NCT01563913|E2|Reported Event|Placebo:|Placebo: Sugar Pill, taken for 1.5 years
200996|NCT01563913|E1|Reported Event|Docosahexaenoic Acid|Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years
200998|NCT01563536|B2|Baseline|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
200999|NCT01563536|B1|Baseline|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201000|NCT01563536|P2|Participant Flow|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201001|NCT01563536|P1|Participant Flow|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201002|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201003|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201004|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201005|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201006|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201007|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201008|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201009|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201010|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201011|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201012|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201013|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201014|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201015|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201016|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201017|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201018|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201019|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201020|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201021|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201022|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201023|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201024|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201025|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201026|NCT01563536|E2|Reported Event|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201027|NCT01563536|E1|Reported Event|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
201028|NCT01563406|B5|Baseline|Total|Total of all reporting groups
201029|NCT01563406|B4|Baseline|Chlorhexidine+Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec
201030|NCT01563406|B3|Baseline|Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
201031|NCT01563406|B2|Baseline|Chlorhexidine+Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec
201032|NCT01563406|B1|Baseline|Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec
201033|NCT01563406|P4|Participant Flow|Chlorhexidine+Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec
201034|NCT01563406|P3|Participant Flow|Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
201035|NCT01563406|P2|Participant Flow|Chlorhexidine+Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec
201036|NCT01563406|P1|Participant Flow|Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec
201037|NCT01563406|O4|Outcome|Chlorhexidine+Alcohol, 5 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec.
201038|NCT01563406|O3|Outcome|Alcohol, 5 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
201039|NCT01563406|O2|Outcome|Chlorhexidine+Alcohol, 15 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec.
201040|NCT01563406|O1|Outcome|Alcohol, 15 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec.
201041|NCT01563406|O4|Outcome|Chlorhexidine+Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec
201042|NCT01563406|O3|Outcome|Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
201043|NCT01563406|O2|Outcome|Chlorhexidine+Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec
201044|NCT01563406|O1|Outcome|Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec
201045|NCT01563406|O4|Outcome|Chlorhexidine+Alcohol, 5 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec.
201046|NCT01563406|O3|Outcome|Alcohol, 5 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
201047|NCT01563406|O2|Outcome|Chlorhexidine+Alcohol, 15 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec.
201382|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily, 10 week treatment period."
201048|NCT01563406|O1|Outcome|Alcohol, 15 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec.
201049|NCT01563406|E4|Reported Event|Chlorhexidine+Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec
201050|NCT01563406|E3|Reported Event|Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
201051|NCT01563406|E2|Reported Event|Chlorhexidine+Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec
201052|NCT01563406|E1|Reported Event|Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec
201053|NCT01563198|B1|Baseline|Comfort Talk® Training|"The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort TalkTm to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests~Comfort Talk: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
201054|NCT01563198|P1|Participant Flow|Comfort TalkTM Training|"The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort TalkTm to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests~Comfort Talk: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
201055|NCT01563198|O1|Outcome|Comfort TalkTM Training|"The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort TalkTm to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests~Comfort Talk: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
201056|NCT01563198|O1|Outcome|Comfort TalkTM Training|"The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort TalkTm to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests~Comfort Talk: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
201057|NCT01563198|O1|Outcome|Comfort TalkTM Training|"The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort TalkTm to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests~Comfort Talk: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
201058|NCT01563198|E1|Reported Event|Comfort TalkTM Training|"The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort TalkTm to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests~Comfort Talk: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
201059|NCT01563185|B1|Baseline|DUEXIS|"800 mg ibuprofen/26.6 mg famotidine~800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day"
201060|NCT01563185|P1|Participant Flow|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
201061|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
201062|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
201063|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
201064|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
201065|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
201066|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
201067|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
201068|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
201069|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
201070|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
201071|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
201072|NCT01563185|E1|Reported Event|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
201073|NCT01563172|B1|Baseline|Overall|This was a five arm cross-over study. Five arms were divided according to the different treatment regimens, the participants were received all the following treatment regimens during the study: 1. Experimental dentifrice 0.5 grams (g) for 45 seconds, 2. Experimental dentifrice 0.5g for 2 minutes, 3. Experimental dentifrice 1.5g for 45 seconds, 4. Experimental dentifrice 1.5g for 2 minutes, and 5. Control dentifrice 1.5g for 2 minutes only.
201074|NCT01563172|P1|Participant Flow|Overall|This was a five arm cross-over study. Five arms were divided according to the different treatment regimens, the participants were received all the following treatment regimens during the study: 1. Experimental dentifrice 0.5 grams (g) for 45 seconds, 2. Experimental dentifrice 0.5g for 2 minutes, 3. Experimental dentifrice 1.5g for 45 seconds, 4. Experimental dentifrice 1.5g for 2 minutes, and 5. Control dentifrice 1.5g for 2 minutes only.
201075|NCT01563172|O2|Outcome|Contol Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of control dentifrice.
201076|NCT01563172|O1|Outcome|Experimental Dentifrice 1.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
201077|NCT01563172|O2|Outcome|Experimental Dentifrice 1.5g, 45 Seconds Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
201078|NCT01563172|O1|Outcome|Experimental Dentifrice 0.5g, 45 Seconds Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 0.5g dose of experimental dentifrice.
201079|NCT01563172|O2|Outcome|Experimental Dentifrice 1.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
201080|NCT01563172|O1|Outcome|Experimental Dentifrice 0.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 0.5g dose of experimental dentifrice.
201081|NCT01563172|O2|Outcome|Experimental Dentifrice 0.5g, 45 Seconds Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 0.5g dose of experimental dentifrice.
201082|NCT01563172|O1|Outcome|Experimental Dentifrice 0.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 0.5g dose of experimental dentifrice.
201083|NCT01563172|O2|Outcome|Experimental Dentifrice 1.5g, 45 Seconds Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
201084|NCT01563172|O1|Outcome|Experimental Dentifrice 1.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
201085|NCT01563172|O2|Outcome|Contol Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of control dentifrice.
201086|NCT01563172|O1|Outcome|Experimental Dentifrice 1.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
201087|NCT01563172|O2|Outcome|Experimental Dentifrice 1.5g, 45 Seconds Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
201088|NCT01563172|O1|Outcome|Experimental Dentifrice 0.5g, 45 Seconds Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 0.5g dose of experimental dentifrice.
201089|NCT01563172|O2|Outcome|Experimental Dentifrice 1.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
201090|NCT01563172|O1|Outcome|Experimental Dentifrice 0.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 0.5g dose of experimental dentifrice
201091|NCT01563172|O2|Outcome|Experimental Dentifrice 0.5g, 45 Seconds Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 0.5g dose of experimental dentifrice.
201092|NCT01563172|O1|Outcome|Experimental Dentifrice 0.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 0.5g dose of experimental dentifrice.
201093|NCT01563172|O2|Outcome|Experimental Dentifrice 1.5g, 45 Seconds Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
201094|NCT01563172|O1|Outcome|Experimental Dentifrice 1.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
201095|NCT01563172|E5|Reported Event|Contol Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with control dentifrice.
201096|NCT01563172|E4|Reported Event|Experimental Dentifrice 1.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
201097|NCT01563172|E3|Reported Event|Experimental Dentifrice 1.5g, 45 Seconds Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
201098|NCT01563172|E2|Reported Event|Experimental Dentifrice 0.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 0.5g dose of experimental dentifrice.
201099|NCT01563172|E1|Reported Event|Experimental Dentifrice 0.5g, 45 Seconds Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 0.5g dose of experimental dentifrice.
201100|NCT01563081|B3|Baseline|Total|Total of all reporting groups
201101|NCT01563081|B2|Baseline|Levocetirizine: >=12 Months and <24 Months Old|Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
201102|NCT01563081|B1|Baseline|Levocetirizine: >=6 Months and <12 Months Old|Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.
201103|NCT01563081|P2|Participant Flow|Levocetirizine: >=12 Months and <24 Months Old|Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
201104|NCT01563081|P1|Participant Flow|Levocetirizine: >=6 Months and <12 Months Old|Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.
201105|NCT01563081|O2|Outcome|Levocetirizine: >=12 Months and <24 Months Old|Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
201106|NCT01563081|O1|Outcome|Levocetirizine: >=6 Months and <12 Months Old|Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.
201107|NCT01563081|O1|Outcome|Levocetrizine: Total Population|Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
201108|NCT01563081|O1|Outcome|Levocetrizine: Total Population|Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
201109|NCT01563081|O1|Outcome|Levocetirizine: Total Population|Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
201110|NCT01563081|O3|Outcome|Levocetirizine: Total Population|Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
201111|NCT01563081|O2|Outcome|Levocetirizine: >=12 Months and <24 Months Old|Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
201112|NCT01563081|O1|Outcome|Levocetirizine: >=6 Months and <12 Months Old|Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.
201113|NCT01563081|E3|Reported Event|Levocetirizine: Total Population|Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
201114|NCT01563081|E2|Reported Event|Levocetirizine: >=12 Months and <24 Months Old|Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
201115|NCT01563081|E1|Reported Event|Levocetirizine: >=6 Months and <12 Months Old|Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.
201116|NCT01563055|B1|Baseline|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201117|NCT01563055|P1|Participant Flow|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201118|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201119|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201181|NCT01563029|P4|Participant Flow|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201120|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201121|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201122|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201123|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201124|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201125|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201126|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201182|NCT01563029|P3|Participant Flow|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201127|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201128|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201129|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201130|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201131|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201132|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201133|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201183|NCT01563029|P2|Participant Flow|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201134|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201135|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201136|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201137|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201138|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201139|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201140|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201184|NCT01563029|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201141|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201142|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201143|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201144|NCT01563055|O1|Outcome|Overall Study Arm|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201145|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201146|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201147|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201185|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201148|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201149|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201150|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201151|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201152|NCT01563055|O1|Outcome|Ofatumumab +Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201153|NCT01563055|O1|Outcome|Overall Study Arm|ar. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201154|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201186|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201383|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201155|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201156|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201157|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201158|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201159|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201160|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201161|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201187|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201162|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201163|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201164|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201165|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201166|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201167|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201168|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201188|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201169|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201170|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201171|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201172|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
201173|NCT01563055|E1|Reported Event|Ofatumumab+Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28 day cycle in combination with chlorambucil 10 mg/meter squared (m^2) orally on Days 1-7 of every 28 day cycle for a minimum of 3 cycles, until best overall response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 8
201174|NCT01563029|B6|Baseline|Total|Total of all reporting groups
201175|NCT01563029|B5|Baseline|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201176|NCT01563029|B4|Baseline|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201177|NCT01563029|B3|Baseline|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201178|NCT01563029|B2|Baseline|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201179|NCT01563029|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201180|NCT01563029|P5|Participant Flow|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201189|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201190|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201191|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201192|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201193|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201194|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201195|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201196|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201197|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201198|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201199|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201200|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201201|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201202|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201203|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201204|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201205|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201206|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201207|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201384|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201208|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201209|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201210|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201211|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201212|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201213|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201214|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201215|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201216|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201217|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201218|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201219|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201220|NCT01563029|O6|Outcome|Average of FF 50 µg OD and FF 100 µg OD|All participants who received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks and all participants who FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201221|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201222|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201223|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201224|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201225|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201295|NCT01562548|P1|Participant Flow|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
201385|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201226|NCT01563029|E5|Reported Event|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201227|NCT01563029|E4|Reported Event|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201228|NCT01563029|E3|Reported Event|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201229|NCT01563029|E2|Reported Event|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201230|NCT01563029|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
201231|NCT01563003|B3|Baseline|Total|Total of all reporting groups
201232|NCT01563003|B2|Baseline|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
201233|NCT01563003|B1|Baseline|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases~Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
201234|NCT01563003|P2|Participant Flow|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
201235|NCT01563003|P1|Participant Flow|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases~Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
201236|NCT01563003|O2|Outcome|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
201237|NCT01563003|O1|Outcome|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases~Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
201238|NCT01563003|O2|Outcome|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
201239|NCT01563003|O1|Outcome|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases~Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
201240|NCT01563003|O2|Outcome|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
201241|NCT01563003|O1|Outcome|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases~Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
201242|NCT01563003|E2|Reported Event|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
201243|NCT01563003|E1|Reported Event|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases~Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
201244|NCT01562886|B1|Baseline|Rilpivirine and Truvada|TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily
201245|NCT01562886|P1|Participant Flow|Rilpivirine and Truvada|TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily
201246|NCT01562886|O1|Outcome|Rilpivirine and Truvada|"TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily~Rilpivirine: Rilpivirine 25mg"
201247|NCT01562886|O1|Outcome|Rilpivirine and Truvada|"TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily~Rilpivirine: Rilpivirine 25mg"
201248|NCT01562886|E1|Reported Event|Rilpivirine and Truvada|"TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily~Rilpivirine: Rilpivirine 26mg"
201249|NCT01562873|B1|Baseline|Ruxolitinib-Cohort A|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
201250|NCT01562873|P2|Participant Flow|Ruxolitinib-Cohort B|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
201251|NCT01562873|P1|Participant Flow|Ruxolitinib-Cohort A|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
201252|NCT01562873|O1|Outcome|Ruxolitinib-Cohort A|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
201253|NCT01562873|O1|Outcome|Ruxolitinib-Cohort A|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
201254|NCT01562873|O1|Outcome|Ruxolitinib-Cohort A|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
201296|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201297|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201255|NCT01562873|O1|Outcome|Ruxolitinib-Cohort A|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
201256|NCT01562873|E1|Reported Event|Ruxolitinib-Cohort A|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
201257|NCT01562756|B1|Baseline|HVLA-SM|"High velocity, low amplitude lumbo-pelvic manipulation~HVLA-SM: High velocity, low amplitude spinal manipulation"
201258|NCT01562756|P1|Participant Flow|HVLA-SM|"High velocity, low amplitude lumbo-pelvic manipulation~HVLA-SM: High velocity, low amplitude spinal manipulation"
201259|NCT01562756|O1|Outcome|Feasibility Outcomes|The feasibility outcomes (Primary outcomes 1 & 2) for this study include participant recruitment, enrollment, and the duration of the study.
201260|NCT01562756|O1|Outcome|Feasibility Outcomes|The feasibility outcomes (Primary outcomes 1 & 2) for this study include participant recruitment, enrollment, and the duration of the study.
201261|NCT01562756|E1|Reported Event|HVLA-SM|"High velocity, low amplitude lumbo-pelvic manipulation~HVLA-SM: High velocity, low amplitude spinal manipulation"
201262|NCT01562743|B1|Baseline|SPM 962|Rotigotine transdermal patch
201263|NCT01562743|P1|Participant Flow|SPM 962|"Rotigotine transdermal patch~A patch containing 2.25 - 6.75mg of rotigotine was administered once a day."
201264|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
201265|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
201266|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
201267|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
201268|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
201269|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
201270|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
201271|NCT01562743|E1|Reported Event|SPM 962|Rotigotine transdermal patch
201272|NCT01562678|B3|Baseline|Total|Total of all reporting groups
201273|NCT01562678|B2|Baseline|Placebo First, Then Liraglutide|14 participants were randomized to receive Placebo and then were cross-overed to receive Liraglutide
201274|NCT01562678|B1|Baseline|Liraglutide First, Then Placebo|14 participants were randomized to receive Liraglutide and then were cross-overed to receive placebo
201275|NCT01562678|P2|Participant Flow|Placebo First, Then Liraglutide|14 participants were randomized to receive Placebo and then were cross-overed to receive Liraglutide
201276|NCT01562678|P1|Participant Flow|Liraglutide First, Then Placebo|14 participants were randomized to receive Liraglutide and then were cross-overed to receive placebo
201277|NCT01562678|O2|Outcome|Placebo|Placebo: In the placebo phase of this randomized, placebo controlled, cross-over, double-blinded study to assess the effects of liraglutide, subjects will self-inject placebo once per day for 18 days. Participants had this first or second (liraglutide was the other phase).
201278|NCT01562678|O1|Outcome|Liraglutide|Liraglutide: In the experimental phase of this randomized, placebo-controlled, cross-over, double-blinded study to assess the effects of liraglutide, subjects started the treatment with a dose of 0.6 mg for the first week, then 1.2 mg for the second week and 1.8 mg for 3 days in the third week. This sequence may have occurred for their first phase or second phase (placebo was the other phase).
201279|NCT01562678|E2|Reported Event|Placebo|14 participants were randomized to receive Placebo and then were cross-overed to receive Liraglutide and 14 participants were randomized to receive Liraglutide and then were cross-overed to receive placebo
201280|NCT01562678|E1|Reported Event|Liraglutide|14 participants were randomized to receive Liraglutide and then were cross-overed to receive placebo and 14 participants were randomized to receive Placebo and then were cross-overed to receive Liraglutide
201281|NCT01562613|B1|Baseline|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
201282|NCT01562613|P1|Participant Flow|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
201283|NCT01562613|O1|Outcome|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
201284|NCT01562613|O1|Outcome|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
201285|NCT01562613|O1|Outcome|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
201286|NCT01562613|E1|Reported Event|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
201287|NCT01562548|B5|Baseline|Total|Total of all reporting groups
201288|NCT01562548|B4|Baseline|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201289|NCT01562548|B3|Baseline|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201290|NCT01562548|B2|Baseline|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
201291|NCT01562548|B1|Baseline|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
201292|NCT01562548|P4|Participant Flow|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201293|NCT01562548|P3|Participant Flow|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201294|NCT01562548|P2|Participant Flow|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
201298|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
201299|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
201300|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201301|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201302|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
201303|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
201304|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201305|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201306|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
201307|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
201308|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201309|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201310|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
201311|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
201312|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201313|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201314|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
201315|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
201316|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201317|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201318|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
201319|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
201320|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201321|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201322|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
201323|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
201324|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201325|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201326|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
201327|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
201328|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201329|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201330|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
201331|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
201332|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201333|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201334|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
201335|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
201336|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID for 7 consecutive days
201337|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201338|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID for 7 consecutive days
201339|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
201340|NCT01562548|E4|Reported Event|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201341|NCT01562548|E3|Reported Event|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
201342|NCT01562548|E2|Reported Event|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
201343|NCT01562548|E1|Reported Event|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
201344|NCT01562327|B1|Baseline|Tocilizumab|Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
201345|NCT01562327|P1|Participant Flow|Tocilizumab|Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
201346|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
201347|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
201348|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
201349|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
201350|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
201351|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
201352|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
201353|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
201354|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
201355|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
201356|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
201357|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
201358|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
201359|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
201360|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
201361|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
201362|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
201363|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
201364|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
201365|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
201366|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
201367|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
201368|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
201369|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
201370|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
201371|NCT01562327|E1|Reported Event|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
201372|NCT01562314|B3|Baseline|Total|Total of all reporting groups
201373|NCT01562314|B2|Baseline|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201374|NCT01562314|B1|Baseline|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201375|NCT01562314|P2|Participant Flow|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201376|NCT01562314|P1|Participant Flow|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201377|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken, twice daily. 10 week treatment period.
201378|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily, 10 week treatment period."
201379|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201380|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201386|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201387|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201388|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201389|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201390|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201391|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201392|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201393|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201394|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201395|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201396|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201397|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201398|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201399|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201400|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201401|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken, twice daily. 10 week treatment period.
201402|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily, 10 week treatment period."
201403|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201404|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201405|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201406|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201407|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201408|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201409|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201410|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201411|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201412|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201413|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201414|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201415|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201416|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201417|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201418|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201419|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201420|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201421|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201422|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201423|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201424|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201425|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201426|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201427|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201428|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201429|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201430|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201431|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201432|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201433|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201434|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201435|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201436|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201437|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201438|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201439|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201440|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201441|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201442|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201443|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201444|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201445|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201446|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201447|NCT01562314|E2|Reported Event|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
201448|NCT01562314|E1|Reported Event|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
201449|NCT01562275|B14|Baseline|Total|Total of all reporting groups
201450|NCT01562275|B13|Baseline|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201451|NCT01562275|B12|Baseline|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201452|NCT01562275|B11|Baseline|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201453|NCT01562275|B10|Baseline|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201454|NCT01562275|B9|Baseline|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201455|NCT01562275|B8|Baseline|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201456|NCT01562275|B7|Baseline|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201457|NCT01562275|B6|Baseline|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201458|NCT01562275|B5|Baseline|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201459|NCT01562275|B4|Baseline|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201460|NCT01562275|B3|Baseline|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201461|NCT01562275|B2|Baseline|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201462|NCT01562275|B1|Baseline|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201463|NCT01562275|P13|Participant Flow|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201464|NCT01562275|P12|Participant Flow|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201465|NCT01562275|P11|Participant Flow|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
202153|NCT01559311|B2|Baseline|CRT-P ON|Echo-guided Group – CRT-P Standard Therapy
201466|NCT01562275|P10|Participant Flow|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201467|NCT01562275|P9|Participant Flow|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201468|NCT01562275|P8|Participant Flow|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201469|NCT01562275|P7|Participant Flow|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201470|NCT01562275|P6|Participant Flow|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201471|NCT01562275|P5|Participant Flow|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201472|NCT01562275|P4|Participant Flow|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201473|NCT01562275|P3|Participant Flow|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201474|NCT01562275|P2|Participant Flow|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201475|NCT01562275|P1|Participant Flow|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 milligrams (mg) cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201476|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201477|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201478|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201479|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201480|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201481|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201482|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201483|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201484|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201485|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201486|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201487|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201488|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201489|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201490|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201491|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201492|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201493|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201494|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201495|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201496|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201497|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201498|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201499|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201500|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201501|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201665|NCT01561898|O2|Outcome|PLA/PAL Group|PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
201502|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201503|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201504|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201505|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201506|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201507|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201508|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201509|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201510|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201511|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201512|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201513|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201514|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201515|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201516|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201517|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201518|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201519|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201520|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201521|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201522|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201523|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201524|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201525|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201526|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201527|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201528|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201529|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201530|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201531|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201532|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201533|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201534|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201535|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201536|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201537|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201721|NCT01561703|P2|Participant Flow|Control|"Patients will NOT receive postoperative antibiotic~No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics"
201538|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201539|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201540|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201541|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201542|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201543|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201544|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201545|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201546|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201547|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201548|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201549|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201550|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201551|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201552|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201553|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201554|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201555|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201778|NCT01561430|O2|Outcome|35 mg LY2886721|LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
201556|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201557|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201558|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201559|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201560|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201561|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201562|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201563|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201564|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201565|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201566|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201567|NCT01562275|O1|Outcome|DECs and Expansion Cohorts|Included all participants who were treated under Stage 1 (Dose Escalation Cohorts) and Stage 2 (Dose Expansion Cohorts).
201568|NCT01562275|O1|Outcome|Stage 1 DECs|During Stage 1, participants received cobimetinib and ipatasertib combination doses either under Arm A (21/7 dosing schedule [cobimetinib and ipatasertib taken concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22-28, every 28 days]) or under Arm B (intermittent cobimetinib dosing schedule [ipatasertib taken once daily on Days 1-21 consecutively with concurrent dosing of cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days)] until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201569|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201570|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201571|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201572|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201573|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201779|NCT01561430|O1|Outcome|15 mg LY2886721|LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
201574|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201575|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201576|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201577|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201578|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201579|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201580|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201581|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201582|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201583|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201584|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201585|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201586|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201587|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201588|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201589|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201590|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201591|NCT01562275|E13|Reported Event|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201666|NCT01561898|O1|Outcome|NO/PAL|NO/PAL: group consisting of new patients. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
202154|NCT01559311|B1|Baseline|CRT-P OFF|Echo-guided Group – DDDR Standard Therapy
201592|NCT01562275|E12|Reported Event|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201593|NCT01562275|E11|Reported Event|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201594|NCT01562275|E10|Reported Event|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201595|NCT01562275|E9|Reported Event|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201596|NCT01562275|E8|Reported Event|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201597|NCT01562275|E7|Reported Event|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201598|NCT01562275|E6|Reported Event|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201599|NCT01562275|E5|Reported Event|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201600|NCT01562275|E4|Reported Event|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201601|NCT01562275|E3|Reported Event|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201602|NCT01562275|E2|Reported Event|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201603|NCT01562275|E1|Reported Event|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
201604|NCT01562132|B3|Baseline|Total|Total of all reporting groups
201605|NCT01562132|B2|Baseline|Fluconazole Alone|"Fluconazole monotherapy~Fluconazole: fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
201606|NCT01562132|B1|Baseline|5FC Plus Fluconazole|"Combination therapy with oral fluconazole and flucytosine~Flucytosine and fluconazole: Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
201607|NCT01562132|P2|Participant Flow|Fluconazole Alone|"Fluconazole monotherapy~Fluconazole: fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
201608|NCT01562132|P1|Participant Flow|5FC Plus Fluconazole|"Combination therapy with oral fluconazole and flucytosine~Flucytosine and fluconazole: Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
201609|NCT01562132|O2|Outcome|Fluconazole Alone|"Fluconazole monotherapy~Fluconazole: fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
201610|NCT01562132|O1|Outcome|5FC Plus Fluconazole|"Combination therapy with oral fluconazole and flucytosine~Flucytosine and fluconazole: Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
201611|NCT01562132|E2|Reported Event|Fluconazole Alone|"Fluconazole monotherapy~Fluconazole: fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
201612|NCT01562132|E1|Reported Event|5FC Plus Fluconazole|"Combination therapy with oral fluconazole and flucytosine~Flucytosine and fluconazole: Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
201613|NCT01561976|B7|Baseline|Total|Total of all reporting groups
201614|NCT01561976|B6|Baseline|METLEAD G2 Forte, METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed|In this sequence participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fasting state in period 2 and METLEAD ForteSR 1000 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201615|NCT01561976|B5|Baseline|METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting, METLEAD G2 Forte|In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fasting state in period 2 and METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201616|NCT01561976|B4|Baseline|METLEAD ForteSR-Fasting, METLEAD G2 Forte, METLEAD ForteSR-Fed|In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state in period 1, METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201617|NCT01561976|B3|Baseline|METLEAD ForteSR-Fed, METLEAD G2 Forte, METLEAD ForteSR-Fasting|In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state in period 1, METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fasting state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201618|NCT01561976|B2|Baseline|METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed, METLEAD G2 Forte|In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state in period 1, METLEAD ForteSR 1000 mg tablet in fed state in period 2 and METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201619|NCT01561976|B1|Baseline|METLEAD G2 Forte, METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting|In this sequence participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fasting state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. Dosing was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201620|NCT01561976|P6|Participant Flow|METLEAD G2 Forte, METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed|In this sequence participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fasting state in period 2 and METLEAD ForteSR 1000 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201667|NCT01561898|O4|Outcome|OLZ/PAL|OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
201780|NCT01561430|O4|Outcome|Placebo|Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
201621|NCT01561976|P5|Participant Flow|METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting, METLEAD G2 Forte|In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fasting state in period 2 and METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201622|NCT01561976|P4|Participant Flow|METLEAD ForteSR-Fasting, METLEAD G2 Forte, METLEAD ForteSR-Fed|In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state in period 1, METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201623|NCT01561976|P3|Participant Flow|METLEAD ForteSR-Fed, METLEAD G2 Forte, METLEAD ForteSR-Fasting|In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state in period 1, METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fasting state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201624|NCT01561976|P2|Participant Flow|METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed, METLEAD G2 Forte|In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state in period 1, METLEAD ForteSR 1000 mg tablet in fed state in period 2 and METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201625|NCT01561976|P1|Participant Flow|METLEAD G2 Forte, METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting|In this sequence participants received single oral dose of METLEAD G2 Forte 1000 milligrams (mg)/2 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fasting state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1 (day after the dosing day), breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. Dosing was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post dose respectively.
201626|NCT01561976|O3|Outcome|METLEAD G2 Forte|Participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201627|NCT01561976|O2|Outcome|METLEAD ForteSR-Fed|Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201628|NCT01561976|O1|Outcome|METLEAD ForteSR-Fasting|Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state. In the fasting conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201629|NCT01561976|O3|Outcome|METLEAD G2 Forte|Participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201668|NCT01561898|O3|Outcome|PAL/PAL Group|PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
201630|NCT01561976|O2|Outcome|METLEAD ForteSR-Fed|Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201631|NCT01561976|O1|Outcome|METLEAD ForteSR-Fasting|Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state. In the fasting conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201632|NCT01561976|O3|Outcome|METLEAD G2 Forte|Participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201633|NCT01561976|O2|Outcome|METLEAD ForteSR-Fed|Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201634|NCT01561976|O1|Outcome|METLEAD ForteSR-Fasting|Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state. In the fasting conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201635|NCT01561976|O3|Outcome|METLEAD G2 Forte|Participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201636|NCT01561976|O2|Outcome|METLEAD ForteSR-Fed|Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201637|NCT01561976|O1|Outcome|METLEAD ForteSR-Fasting|Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state. In the fasting conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201638|NCT01561976|O3|Outcome|METLEAD G2 Forte|Participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201639|NCT01561976|O2|Outcome|METLEAD ForteSR-Fed|Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201640|NCT01561976|O1|Outcome|METLEAD ForteSR-Fasting|Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state. In the fasting conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201641|NCT01561976|O3|Outcome|METLEAD G2 Forte|Participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201642|NCT01561976|O2|Outcome|METLEAD ForteSR-Fed|Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201643|NCT01561976|O1|Outcome|METLEAD ForteSR-Fasting|Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state. In the fasting conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201644|NCT01561976|O3|Outcome|METLEAD G2 Forte|Participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
202155|NCT01559311|P3|Participant Flow|DDDR|Control Group – DDDR Standard Therapy
201645|NCT01561976|O2|Outcome|METLEAD ForteSR-Fed|Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201646|NCT01561976|O1|Outcome|METLEAD ForteSR-Fasting|Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state. In the fasting conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201647|NCT01561976|O3|Outcome|METLEAD G2 Forte|Participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201648|NCT01561976|O2|Outcome|METLEAD ForteSR-Fed|Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201649|NCT01561976|O1|Outcome|METLEAD ForteSR-Fasting|Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state. In the fasting conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201650|NCT01561976|E3|Reported Event|METLEAD G2 Forte|Participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201651|NCT01561976|E2|Reported Event|METLEAD ForteSR-Fed|Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201652|NCT01561976|E1|Reported Event|METLEAD ForteSR-Fasting|Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state. In the fasting conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
201653|NCT01561898|B5|Baseline|Total|Total of all reporting groups
201654|NCT01561898|B4|Baseline|OLZ/PAL|OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
201655|NCT01561898|B3|Baseline|PAL/PAL Group|PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
201656|NCT01561898|B2|Baseline|PLA/PAL Group|PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
201657|NCT01561898|B1|Baseline|NO/PAL Group|NO/PAL: group consisting of new patients. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
201658|NCT01561898|P4|Participant Flow|OLZ/PAL|OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
201659|NCT01561898|P3|Participant Flow|PAL/PAL Group|PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
201660|NCT01561898|P2|Participant Flow|PLA/PAL Group|PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
201661|NCT01561898|P1|Participant Flow|NO/PAL Group|NO/PAL: group consisting of new patients. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
201662|NCT01561898|O1|Outcome|Entire Group|Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
201663|NCT01561898|O4|Outcome|OLZ/PAL|OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
201664|NCT01561898|O3|Outcome|PAL/PAL Group|PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
203401|NCT01553318|E1|Reported Event|Ketotifen|Received ketotifen the active drug
201669|NCT01561898|O2|Outcome|PLA/PAL Group|PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
201670|NCT01561898|O1|Outcome|NO/PAL|NO/PAL: group consisting of new patients. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
201671|NCT01561898|E1|Reported Event|Entire Group|Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
201672|NCT01561755|B3|Baseline|Total|Total of all reporting groups
201673|NCT01561755|B2|Baseline|Placebo|Saline 2gr/kg over 2 days of saline
201674|NCT01561755|B1|Baseline|Intravenous Immunoglobulin|Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
201675|NCT01561755|P2|Participant Flow|Placebo|Saline 2gr/kg over 2 days of saline
201676|NCT01561755|P1|Participant Flow|Intravenous Immunoglobulin|Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
201677|NCT01561755|O2|Outcome|Placebo|Saline 2gr/kg over 2 days of saline
201678|NCT01561755|O1|Outcome|Intravenous Immunoglobulin|Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
201679|NCT01561755|O2|Outcome|Placebo|Saline 2gr/kg over 2 days of saline
201680|NCT01561755|O1|Outcome|Intravenous Immunoglobulin|Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
201681|NCT01561755|O2|Outcome|Placebo|Saline 2gr/kg over 2 days of saline
201682|NCT01561755|O1|Outcome|Intravenous Immunoglobulin|Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
201683|NCT01561755|O2|Outcome|Placebo|Saline 2gr/kg over 2 days of saline
201684|NCT01561755|O1|Outcome|Intravenous Immunoglobulin|Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
201685|NCT01561755|O2|Outcome|Placebo|Saline 2gr/kg over 2 days of saline
201686|NCT01561755|O1|Outcome|Intravenous Immunoglobulin|Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
201687|NCT01561755|O2|Outcome|Placebo|Saline 2gr/kg over 2 days of saline
201688|NCT01561755|O1|Outcome|Intravenous Immunoglobulin|Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
201689|NCT01561755|O2|Outcome|Placebo|Saline 2gr/kg over 2 days of saline
201690|NCT01561755|O1|Outcome|Intravenous Immunoglobulin|Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
201691|NCT01561755|E2|Reported Event|Placebo|Saline 2gr/kg over 2 days of saline
201692|NCT01561755|E1|Reported Event|Intravenous Immunoglobulin|Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
201693|NCT01561716|B7|Baseline|Total|Total of all reporting groups
201694|NCT01561716|B6|Baseline|Crossover Sequence 6|Resting/treadmill/Wii Fit 3 bouts/Wii Fit Free Run
201695|NCT01561716|B5|Baseline|Crossover Sequence 5|Resting/treadmill/Wii Fit Free Run/Wii Fit 3 bouts
201696|NCT01561716|B4|Baseline|Crossover Sequence 4|Resting/Wii Fit 3 bouts/treadmill/Wii Fit Free Run
201697|NCT01561716|B3|Baseline|Crossover Sequence 3|Resting/Wii Fit 3 bouts/Wii Fit Free Run/treadmill
201698|NCT01561716|B2|Baseline|Crossover Sequence 2|Resting/Wii Fit Free Run/treadmill/Wii Fit 3 bouts
201699|NCT01561716|B1|Baseline|Crossover Sequence 1|Resting/Wii Fit Free Run/Wii Fit 3 bouts/treadmill
201700|NCT01561716|P6|Participant Flow|Crossover Sequence 6|Resting/treadmill/Wii Fit 3 bouts/Wii Fit Free Run
201701|NCT01561716|P5|Participant Flow|Crossover Sequence 5|Resting/treadmill/Wii Fit Free Run/Wii Fit 3 bouts
201702|NCT01561716|P4|Participant Flow|Crossover Sequence 4|Resting/Wii Fit 3 bouts/treadmill/Wii Fit Free Run
201703|NCT01561716|P3|Participant Flow|Crossover Sequence 3|Resting/Wii Fit 3 bouts/Wii Fit Free Run/treadmill
201704|NCT01561716|P2|Participant Flow|Crossover Sequence 2|Resting/Wii Fit Free Run/treadmill/Wii Fit 3 bouts
201705|NCT01561716|P1|Participant Flow|Crossover Sequence 1|Resting/Wii Fit Free Run/Wii Fit 3 bouts/treadmill
201706|NCT01561716|O6|Outcome|Treadmill Running/Walking|Energy expenditure during 30 min treadmill running/walking
201707|NCT01561716|O5|Outcome|Wii Fit Rhythm Boxing|Energy expenditure during 10 min Wii Fit Rhythm Boxing
201708|NCT01561716|O4|Outcome|Wii Fit Advanced Steps|Energy expenditure during 10 min Wii Fit Advanced Steps
201709|NCT01561716|O3|Outcome|Wii Fit Super Hula Hoop|Energy expenditure during 10 min Wii Fit Super Hula Hoop
201710|NCT01561716|O2|Outcome|Wii Fit Free Run|Energy expenditure during 30 min Wii Fit Free Run
201711|NCT01561716|O1|Outcome|At Rest|Energy expenditure at rest
201712|NCT01561716|E6|Reported Event|Crossover Sequence 6|Resting/treadmill/Wii Fit 3 bouts/Wii Fit Free Run
201713|NCT01561716|E5|Reported Event|Crossover Sequence 5|Resting/treadmill/Wii Fit Free Run/Wii Fit 3 bouts
201714|NCT01561716|E4|Reported Event|Crossover Sequence 4|Resting/Wii Fit 3 bouts/treadmill/Wii Fit Free Run
201715|NCT01561716|E3|Reported Event|Crossover Sequence 3|Resting/Wii Fit 3 bouts/Wii Fit Free Run/treadmill
201716|NCT01561716|E2|Reported Event|Crossover Sequence 2|Resting/Wii Fit Free Run/treadmill/Wii Fit 3 bouts
201717|NCT01561716|E1|Reported Event|Crossover Sequence 1|Resting/Wii Fit Free Run/Wii Fit 3 bouts/treadmill
201718|NCT01561703|B3|Baseline|Total|Total of all reporting groups
201719|NCT01561703|B2|Baseline|Control|"Patients will NOT receive postoperative antibiotic~No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics"
201720|NCT01561703|B1|Baseline|Intervention|"Patients will receive postoperative antibiotic after surgery.~Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .~Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery"
201781|NCT01561430|O3|Outcome|70 mg LY2886721|LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
201722|NCT01561703|P1|Participant Flow|Intervention|"Patients will receive postoperative antibiotic after surgery.~Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .~Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery"
201723|NCT01561703|O2|Outcome|Control|"Patients will NOT receive postoperative antibiotic~No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics"
201724|NCT01561703|O1|Outcome|Intervention|"Patients will receive postoperative antibiotic after surgery.~Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .~Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery"
201725|NCT01561703|E2|Reported Event|Control|"Patients will NOT receive postoperative antibiotic~No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics"
201726|NCT01561703|E1|Reported Event|Intervention|"Patients will receive postoperative antibiotic after surgery.~Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .~Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery"
201727|NCT01561560|B1|Baseline|OVERALL|Delefilcon A contact lenses and narafilcon A contact lenses worn in randomized order. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
201728|NCT01561560|P2|Participant Flow|TRUEYE, Then DAILIES TOTAL1|Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
201729|NCT01561560|P1|Participant Flow|DAILIES TOTAL1, Then TRUEYE|Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
201730|NCT01561560|O2|Outcome|TRUEYE|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks
201731|NCT01561560|O1|Outcome|DAILIES TOTAL1|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks
201732|NCT01561560|E2|Reported Event|TRUEYE|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks
201733|NCT01561560|E1|Reported Event|DAILIES TOTAL1|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks
201734|NCT01561469|B3|Baseline|Total|Total of all reporting groups
201735|NCT01561469|B2|Baseline|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
201736|NCT01561469|B1|Baseline|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
201737|NCT01561469|P2|Participant Flow|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
201738|NCT01561469|P1|Participant Flow|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
201739|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
201740|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
201741|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
201742|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
201782|NCT01561430|O2|Outcome|35 mg LY2886721|LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
201783|NCT01561430|O1|Outcome|15 mg LY2886721|LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
201743|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
201744|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
201745|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
201746|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
201747|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
201748|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
201749|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
201750|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
201751|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
201752|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
201753|NCT01561469|E2|Reported Event|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
201754|NCT01561469|E1|Reported Event|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
201755|NCT01561430|B5|Baseline|Total|Total of all reporting groups
201756|NCT01561430|B4|Baseline|Placebo|Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
201757|NCT01561430|B3|Baseline|70 mg LY2886721|LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
201758|NCT01561430|B2|Baseline|35 mg LY2886721|LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
201759|NCT01561430|B1|Baseline|15 mg LY2886721|LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
201760|NCT01561430|P4|Participant Flow|Placebo|Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
201761|NCT01561430|P3|Participant Flow|70 mg LY2886721|LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
201762|NCT01561430|P2|Participant Flow|35 mg LY2886721|LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
201763|NCT01561430|P1|Participant Flow|15 mg LY2886721|LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
201764|NCT01561430|O4|Outcome|Placebo|Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
201765|NCT01561430|O3|Outcome|70 mg LY2886721|LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
201766|NCT01561430|O2|Outcome|35 mg LY2886721|LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
201767|NCT01561430|O1|Outcome|15 mg LY2886721|LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
201768|NCT01561430|O4|Outcome|Placebo|Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
201769|NCT01561430|O3|Outcome|70 mg LY2886721|70 mg, capsules, administered orally, once daily for 26 weeks.
201770|NCT01561430|O2|Outcome|35 mg LY2886721|LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
201771|NCT01561430|O1|Outcome|15 mg LY2886721|LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
201772|NCT01561430|O4|Outcome|Placebo|Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
201773|NCT01561430|O3|Outcome|70 mg LY2886721|LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
201774|NCT01561430|O2|Outcome|35 mg LY2886721|LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
201775|NCT01561430|O1|Outcome|15 mg LY2886721|LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
201776|NCT01561430|O4|Outcome|Placebo|Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
201777|NCT01561430|O3|Outcome|70 mg LY2886721|LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
201784|NCT01561430|O4|Outcome|Placebo|Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
201785|NCT01561430|O3|Outcome|70 mg LY2886721|LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
201786|NCT01561430|O2|Outcome|35 mg LY2886721|LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
201787|NCT01561430|O1|Outcome|15 mg LY2886721|LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
201788|NCT01561430|O4|Outcome|Placebo|Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
201789|NCT01561430|O3|Outcome|70 mg LY2886721|LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
201790|NCT01561430|O2|Outcome|35 mg LY2886721|LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
201791|NCT01561430|O1|Outcome|15 mg LY2886721|LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
201792|NCT01561430|O4|Outcome|Placebo|Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
201793|NCT01561430|O3|Outcome|70 mg LY2886721|LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
201794|NCT01561430|O2|Outcome|35 mg LY2886721|LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
201795|NCT01561430|O1|Outcome|15 mg LY2886721|LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
201796|NCT01561430|E4|Reported Event|Placebo|Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
201797|NCT01561430|E3|Reported Event|70 mg LY2886721|LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
201798|NCT01561430|E2|Reported Event|35 mg LY2886721|LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
201799|NCT01561430|E1|Reported Event|15 mg LY2886721|LY2886721: 15 mg, capsules, administered orally, once daily for 26 weeks.
201800|NCT01561313|B3|Baseline|Total|Total of all reporting groups
201801|NCT01561313|B2|Baseline|New Formulation of Adalimumab/Current Formulation Adalimumab|First dose with 40 mg of new formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of current formulation of adalimumab in a pre-filled syringe.
201802|NCT01561313|B1|Baseline|Current Formulation Adalimumab/New Formulation of Adalimumab|First dose with 40 mg of current formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of new formulation of adalimumab in a pre-filled syringe.
201803|NCT01561313|P2|Participant Flow|New Formulation of Adalimumab/Current Formulation Adalimumab|First dose with 40 mg of new formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of current formulation of adalimumab in a pre-filled syringe.
201804|NCT01561313|P1|Participant Flow|Current Formulation Adalimumab/New Formulation of Adalimumab|First dose with 40 mg of current formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of new formulation of adalimumab in a pre-filled syringe.
201805|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
201806|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
201807|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
201808|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
201809|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
201810|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
201811|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
201812|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
201813|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
201814|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
201815|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
201816|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
201817|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
201818|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
201819|NCT01561313|E2|Reported Event|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
201820|NCT01561313|E1|Reported Event|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
201821|NCT01561300|B1|Baseline|Study Population|All participants who were randomised
201822|NCT01561300|P2|Participant Flow|Tea, Then Wash Out, Then Control|Subjects first received Tea for one week with with Flow Mediated Dilation (FMD) measurements on day 1 and day 8. After a washout of one week (day 8-15) they received Control for one week with FMD measurements at day 16 and day 22. All FMD measurements were done in a fasted state just before test product intake and exactly 2 hours after test product intake.
201823|NCT01561300|P1|Participant Flow|Control, Then Washout, Then Tea|Subjects first received Control for one week with Flow Mediated Dilation (FMD) measurements on day 1 and day 8. After a washout of one week (day 8-15) they received Tea for one week with FMD measurements at day 16 and day 22. All FMD measurements were done in a fasted state just before test product intake and exactly 2 hours after test product intake.
201824|NCT01561300|O2|Outcome|Control Beverage|Participants when they received control
201825|NCT01561300|O1|Outcome|Tea Beverage|Participants when they received tea
201826|NCT01561300|O2|Outcome|Control Beverage|Participants when they received control
201827|NCT01561300|O1|Outcome|Tea Beverage|Participants when they received tea
201828|NCT01561300|O2|Outcome|Control Beverage|Participants when they received control
201829|NCT01561300|O1|Outcome|Tea Beverage|Participants when they received tea
201830|NCT01561300|E3|Reported Event|Placebo|Subjects when they consumed placebo for 6 days during the run in and during 7 days during the washout
201831|NCT01561300|E2|Reported Event|Control|Subjects when they consumed control for one week
201832|NCT01561300|E1|Reported Event|Tea Extract|Subjects when they consumed tea extract for one week
201833|NCT01561079|B1|Baseline|Fetal|Daily sublingual buprenorphine treatment of pregnant, opioid dependent women Subjects completing any maternal-fetal monitoring at any combination of the following gestational ages: 24, 28, 32 36 weeks
201834|NCT01561079|P1|Participant Flow|Maternal Buprenorphine Treatment|Daily sublingual buprenorphine treatment of pregnant, opioid dependent women Subjects undergo maternal-fetal monitoring at any combination of the following gestational time periods: 24, 28,32, 36 weeks of gestation
201835|NCT01561079|O8|Outcome|FM-FHR 36 Peak|Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level
201836|NCT01561079|O7|Outcome|FM-FHR 32 Peak|Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level
201837|NCT01561079|O6|Outcome|FM-FHR 28 Peak|Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level
201838|NCT01561079|O5|Outcome|FM-FHR 24 Peak|Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level
201839|NCT01561079|O4|Outcome|FM-FHR 36 Trough|Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level
201840|NCT01561079|O3|Outcome|FM-FHR 32 Trough|Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level
201841|NCT01561079|O2|Outcome|FM-FHR 28 Trough|Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level
201842|NCT01561079|O1|Outcome|FM-FHR 24 Trough|Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level
201843|NCT01561079|O8|Outcome|Fetal Movement 36 Peak|Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level
201844|NCT01561079|O7|Outcome|Fetal Movement 32 Peak|Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level
201845|NCT01561079|O6|Outcome|Fetal Movement 28 Peak|Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level
201846|NCT01561079|O5|Outcome|Fetal Movement 24 Peak|Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level
201847|NCT01561079|O4|Outcome|Fetal Movement 36 Trough|Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level
201848|NCT01561079|O3|Outcome|Fetal Movement 32 Trough|Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level
201849|NCT01561079|O2|Outcome|Fetal Movement 28 Trough|Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level
201850|NCT01561079|O1|Outcome|Fetal Movement 24 Trough|Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level
201851|NCT01561079|O8|Outcome|Accelerations36 Peak|Accelerations in fetal heart rate at 36 weeks of gestation at time of peak maternal buprenorphine level
201852|NCT01561079|O7|Outcome|Accelerations 32 Peak|Accelerations in fetal heart rate at 32 weeks of gestation at time of peak maternal buprenorphine level
201853|NCT01561079|O6|Outcome|Accelerations 28 Peak|Accelerations in fetal heart rate at 28 weeks of gestation at time of peak maternal buprenorphine level
201854|NCT01561079|O5|Outcome|Accelerations 24 Peak|Accelerations in fetal heart rate at 24 weeks of gestation at time of peak maternal buprenorphine level
201855|NCT01561079|O4|Outcome|Accelerations 36 Trough|Accelerations in fetal heart rate at 36 weeks of gestation at time of trough maternal buprenorphine level
201856|NCT01561079|O3|Outcome|Accelerations 32 Trough|Accelerations in fetal heart rate at 32 weeks of gestation at time of trough maternal buprenorphine level
201857|NCT01561079|O2|Outcome|Accelerations 28 Trough|Accelerations in fetal heart rate at 28 weeks of gestation at time of trough maternal buprenorphine level
201858|NCT01561079|O1|Outcome|Accelerations 24 Trough|Accelerations in fetal heart rate at 24 weeks of gestation at time of trough maternal buprenorphine level
201859|NCT01561079|O8|Outcome|FHRV 36 Peak|Fetal heart rate variability at 36 weeks gestation at the time of peak maternal buprenorphine levels
201860|NCT01561079|O7|Outcome|FHRV 32 Peak|Fetal heart rate variability at 32 weeks gestation at the time of peak maternal buprenorphine levels
201861|NCT01561079|O6|Outcome|FHRV 28 Peak|Fetal heart rate variability at 28 weeks gestation at the time of peak maternal buprenorphine levels
201862|NCT01561079|O5|Outcome|FHRV 24 Peak|Fetal heart rate variability at 24 weeks gestation at the time of peak maternal buprenorphine levels
201863|NCT01561079|O4|Outcome|FHRV 36 Trough|Fetal heart rate variability at 36 weeks of gestation at time of trough maternal buprenorphine level
201864|NCT01561079|O3|Outcome|FHRV 32 Trough|Fetal heart rate variability at 32 weeks of gestation at time of trough maternal buprenorphine level
201865|NCT01561079|O2|Outcome|FHRV 28 Trough|Fetal heart rate variability at 28 weeks of gestation at time of trough maternal buprenorphine level
201866|NCT01561079|O1|Outcome|FHRV 24 Trough|Fetal heart rate variability at 24 weeks of gestation at time of trough maternal buprenorphine level
201867|NCT01561079|O8|Outcome|FHR 36 Peak|Fetal heart rate in beats per minute at 36 weeks of gestation at time of peak maternal buprenorphine level
201868|NCT01561079|O7|Outcome|FHR 32 Peak|Fetal heart rate in beats per minute at 32 weeks of gestation at time of peak maternal buprenorphine level
201869|NCT01561079|O6|Outcome|FHR 28 Weeks Peak|Fetal heart rate in beats per minute at 28 weeks of gestation at time of peak maternal buprenorphine level
201870|NCT01561079|O5|Outcome|FHR 24 Weeks Peak|Fetal heart rate in beats per minute at 24 weeks of gestation at time of peak maternal buprenorphine level
201871|NCT01561079|O4|Outcome|FHR 36 Weeks Trough|Fetal heart rate in beats per minute at 36 weeks of gestation at time of trough maternal buprenorphine level
201872|NCT01561079|O3|Outcome|FHR 32 Weeks Trough|Fetal heart rate in beats per minute at 32 weeks of gestation at time of trough maternal buprenorphine level
201873|NCT01561079|O2|Outcome|FHR 28 Weeks Trough|Fetal heart rate in beats per minute at 28 weeks of gestation at time of trough maternal buprenorphine level
201874|NCT01561079|O1|Outcome|FHR 24 Weeks Trough|Fetal heart rate in beats per minute at 24 weeks of gestation at trough
201875|NCT01561079|E1|Reported Event|Maternal Buprenorphine Treatment|"Buprenorphine maintenance during pregnancy~Buprenorphine: Daily sublingual buprenorphine treatment of pregnant, opioid dependent women from up to 34 weeks gestation through one month of infant age.~Two severe adverse events were reported in the same infant patient. One infant had congenital heart disease and polydactyly"
201876|NCT01560988|B1|Baseline|All Study Participants|Participants were randomized to receive either borage and echium oils first, and corn oil second, or vice versa
201877|NCT01560988|P2|Participant Flow|First Corn Oil, Then Borage and Echium Seed Oil|Corn oil pills will be taken for six weeks, followed by a 6 week washout. Then subjects received borage and echium oil tablets for six week.
201878|NCT01560988|P1|Participant Flow|First Borage and Echium, Then Corn Oil|Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks, followed by a 6 week washout. Then, subjects were crossed over to receive corn oil (10 g) daily for six weeks
201879|NCT01560988|O2|Outcome|Corn Oil Pills|"Corn oil pills will be taken for six weeks.~Corn oil pills will be taken three times per day for six weeks."
201880|NCT01560988|O1|Outcome|Borage and Echium Seed Oils|"Borage and echium seed oils will be taken for six weeks.~Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks."
201881|NCT01560988|O2|Outcome|Corn Oil Pills|"Corn oil pills will be taken for six weeks.~Corn oil pills will be taken three times per day for six weeks."
201882|NCT01560988|O1|Outcome|Borage and Echium Seed Oils|"Borage and echium seed oils will be taken for six weeks.~Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks."
201883|NCT01560988|O2|Outcome|Corn Oil Pills|"Corn oil pills will be taken for six weeks.~Corn oil pills: Corn oils pills will be taken three times per day for six weeks."
201884|NCT01560988|O1|Outcome|Borage and Echium Seed Oils|"Borage and echium seed oils will be taken for six weeks.~Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks"
201885|NCT01560988|O2|Outcome|Corn Oil Pills|"Corn oil pills will be taken for six weeks.~Corn oil pills: Corn oils pills will be taken three times per day for six weeks."
201886|NCT01560988|O1|Outcome|Borage and Echium Seed Oils|"Borage and echium seed oils will be taken for six weeks.~Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks."
201887|NCT01560988|O1|Outcome|All Study Participants|All study participants, regardless of arm assignment, were genotyped at the LTC4S locus.
201888|NCT01560988|O2|Outcome|Corn Oil Pills|"Corn oil pills will be taken for six weeks.~Corn oil pills: Corn oils pills will be taken three times per day for six weeks"
201889|NCT01560988|O1|Outcome|Borage and Echium Seed Oils|"Borage and echium seed oils will be taken for six weeks.~Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil."
201890|NCT01560988|O2|Outcome|Corn Oil Pills|"Corn oil pills will be taken for six weeks.~Corn oil pills: Corn oils pills will be taken three times per day for six weeks."
201891|NCT01560988|O1|Outcome|Borage and Echium Seed Oils|"Borage and echium seed oils will be taken for six weeks.~Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil."
201892|NCT01560988|O2|Outcome|Corn Oil Pills|"Corn oil pills will be taken for six weeks.~Corn oil pills: Corn oils pills will be taken three times per day for six weeks."
201893|NCT01560988|O1|Outcome|Borage and Echium Seed Oils|"Borage and echium seed oils will be taken for six weeks.~Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks"
201894|NCT01560988|O2|Outcome|Corn Oil Pills|"Corn oil pills will be taken for six weeks.~Corn oil pills will be taken three times per day for six weeks."
201895|NCT01560988|O1|Outcome|Borage and Echium Seed Oils|"Borage and echium seed oils will be taken for six weeks.~Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks."
201896|NCT01560988|O2|Outcome|Corn Oil Pills|"Corn oil pills will be taken for six weeks.~Corn oil pills: Corn oils pills will be taken three times per day for six weeks."
201897|NCT01560988|O1|Outcome|Borage and Echium Seed Oils|"Borage and echium seed oils will be taken for six weeks.~Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks."
201898|NCT01560988|E2|Reported Event|Corn Oil Pills|"Corn oil pills will be taken for six weeks.~Corn oil pills: Corn oils pills will be taken three times per day for six weeks."
201899|NCT01560988|E1|Reported Event|Borage and Echium Seed Oils|"Borage and echium seed oils will be taken for six weeks.~Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks."
201900|NCT01560975|B1|Baseline|Sensimed Triggerfish|SENSIMED Triggerfish®: Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
201901|NCT01560975|P1|Participant Flow|Sensimed Triggerfish|SENSIMED Triggerfish®: Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
201902|NCT01560975|O4|Outcome|noPOAG/ no CPAP|No POAG patients without CPAP therapy
201903|NCT01560975|O3|Outcome|POAG/no CPAP|POAG patients without CPAP therapy
201904|NCT01560975|O2|Outcome|noPOAG/CPAP|no POAG patients with CPAP therapy
201905|NCT01560975|O1|Outcome|POAG/CPAP|POAG patients with CPAP therapy
201906|NCT01560975|O4|Outcome|noPOAG/ no CPAP|No POAG patients without CPAP therapy
201907|NCT01560975|O3|Outcome|POAG/no CPAP|POAG patients without CPAP therapy
201908|NCT01560975|O2|Outcome|noPOAG/CPAP|no POAG patients with CPAP therapy
201909|NCT01560975|O1|Outcome|POAG/CPAP|POAG patients with CPAP therapy
201910|NCT01560975|O2|Outcome|noPOAG/CPAP|Subjects with CPAP
201912|NCT01560975|E1|Reported Event|Sensimed Triggerfish|SENSIMED Triggerfish®: Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
201913|NCT01560819|B3|Baseline|Total|Total of all reporting groups
201914|NCT01560819|B2|Baseline|Donors|Healthy donors (>18 years of age) were chosen by participants. Donors were required to complete a screening questionnaire, provide medical history, and undergo blood and stool tests.
201915|NCT01560819|B1|Baseline|Study Participants|Ten participants between the ages of 7 to 21 years with mild-to moderate UC (pediatric UC activity index [PUCAI] between 15 and 65) were enrolled in the study. PUCAI is a validated tool to measure disease activity in pediatric UC based on clinical symptoms: a score of <10 = remission; 10-34 = mild disease; 35-64 = moderate disease; 65-85 = severe disease. Participants had stable disease activity and medical treatment for UC for 2 months prior to enrollment. Participants' ongoing treatment for UC was not changed. None of the subjects had concurrent C difficile infection.
201916|NCT01560819|P2|Participant Flow|Donors|Healthy donors (>18 years of age) were chosen by the participants. Donors were required to complete a screening questionnaire, provide medical history, and undergo blood and stool tests.
201917|NCT01560819|P1|Participant Flow|Study Participants|Ten participants between the ages of 7 to 21 years with mild-to moderate UC (pediatric UC activity index [PUCAI] between 15 and 65) were enrolled in the study. PUCAI is a validated tool to measure disease activity in pediatric UC based on clinical symptoms: a score of <10 = remission; 10-34 = mild disease; 35-64 = moderate disease; 65-85 = severe disease. Participants had stable disease activity and medical treatment for UC for 2 months prior to enrollment. Participants' ongoing treatment for UC was not changed. None of the subjects had concurrent C difficile infection.
201918|NCT01560819|O1|Outcome|Study Participants|Ten participants between the ages of 7 to 21 years with mild-to moderate ulcerative colitis (UC) (pediatric UC activity index [PUCAI] between 15 and 65) were enrolled in the study. PUCAI is a validated tool to measure disease activity in pediatric UC based on clinical symptoms: a score of <10 = remission; 10-34 = mild disease; 35-64 = moderate disease; 65-85 = severe disease. Participants had stable disease activity and medical treatment for UC for 2 months prior to enrollment. Participants' ongoing treatment for UC was not changed. None of the subjects had concurrent C difficile infection.
201919|NCT01560819|E1|Reported Event|Study Participants|Ten participants between the ages of 7 to 21 years with mild-to moderate UC (pediatric UC activity index [PUCAI] between 15 and 65) were enrolled in the study. Participants had stable disease activity and medical treatment for UC for 2 months prior to enrollment. Participants' ongoing treatment for UC was not changed. None of the subjects had concurrent C difficile infection.
201920|NCT01560507|B4|Baseline|Total|Total of all reporting groups
201921|NCT01560507|B3|Baseline|Bupropion (Zyban) and Nicotine Patches|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.
201922|NCT01560507|B2|Baseline|Nicotine Patches|This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.
201923|NCT01560507|B1|Baseline|Varenicline (Chantix)|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.
201924|NCT01560507|P3|Participant Flow|Bupropion (Zyban) and Nicotine Patches|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.
201925|NCT01560507|P2|Participant Flow|Nicotine Patches|This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.
201926|NCT01560507|P1|Participant Flow|Varenicline (Chantix)|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.
201927|NCT01560507|O3|Outcome|Bupropion (Zyban) and Nicotine Patches|"This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.~bupropion (Zyban) & nicotine patches: After being switched from NRT (occurring at one week before the rescheduled quit date), smokers in this group will receive 150mg of bupropion once daily and 21mg nicotine patch for first 3 days; 150mg of bupropion twice daily and 21mg nicotine patch for 7 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
201928|NCT01560507|O2|Outcome|Nicotine Patches|"This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.~nicotine patches: 21mg nicotine patch for first 11 weeks; 14mg nicotine patch for next 2 weeks; 7mg nicotine patch for final 2 weeks."
201929|NCT01560507|O1|Outcome|Varenicline (Chantix)|"This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.~varenicline (Chantix): For the first 3 days after being switched from NRT (occurring at one week before the rescheduled quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
201930|NCT01560507|O3|Outcome|Bupropion (Zyban) and Nicotine Patches|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.
201931|NCT01560507|O2|Outcome|Nicotine Patches|This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.
201932|NCT01560507|O1|Outcome|Varenicline (Chantix)|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.
201933|NCT01560507|E3|Reported Event|Bupropion (Zyban) and Nicotine Patches|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.
201934|NCT01560507|E2|Reported Event|Nicotine Patches|This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.
201935|NCT01560507|E1|Reported Event|Varenicline (Chantix)|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.
201936|NCT01560429|B3|Baseline|Total|Total of all reporting groups
201937|NCT01560429|B2|Baseline|Continuous Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
201938|NCT01560429|B1|Baseline|Patient-controlled Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in the post-anesthesia care unit (PACU). Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
201939|NCT01560429|P2|Participant Flow|Continuous Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Postoperatively all patients received continuous epidural analgesia at infusion rates to reach pain scores of ≤ 3 while in PACU. Those randomized to the Continuous epidural analgesia group remained on the same CEA regimen.
201940|NCT01560429|P1|Participant Flow|Patient-controlled Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Continuous epidural infusion rates were set to achieve scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 while in PACU. Upon allocation to the preoperatively determined randomization, the PCEA were switched the receive 2/3 of their baseline infusion as continuous background infusion but they also had the option to self administered the remaining 1/3rd of the dose via patient controlled epidural analgesia (PCEA)
201941|NCT01560429|O2|Outcome|Continuous Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
201942|NCT01560429|O1|Outcome|Patient-controlled Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
201943|NCT01560429|O2|Outcome|Continuous Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. CEA infusion rates were set to achieve pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 while in PACU. Those allocated to the CEA group remained on the same continuous epidural infusion rate to which they were optimized.
201944|NCT01560429|O1|Outcome|Patient-controlled Epidural Analgesia|An epidural catheter sited preoperatively so analgesics can be administered postoperatively. Patients were titrated on a continuous analgesic epidural infusion until stable pain scores of ≤ 3 were reached while in PACU. Once stable, they were allocated to their preoperatively determined randomization which meant they still received 2/3rd of the anesthetic as a background infusion but also had the option to self-administer the remaining 1/3rd dose as patient controlled epidural analgesia (PCEA). Rescue analgesia was available upon request.
201945|NCT01560429|E2|Reported Event|Continuous Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
201946|NCT01560429|E1|Reported Event|Patient-controlled Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
201947|NCT01560403|B3|Baseline|Total|Total of all reporting groups
201948|NCT01560403|B2|Baseline|NT/PBO,TED|This group represents those subjects who either participated in Study CL0600-020 and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension Study CL0600-021 (NCT00930644) directly
201949|NCT01560403|B1|Baseline|TED/TED|This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600 021 (NCT00930644)
201950|NCT01560403|P2|Participant Flow|NT/PBO,TED|This group represents those subjects who either participated in Study CL0600-020 and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension Study CL0600-021 (NCT00930644) directly
201951|NCT01560403|P1|Participant Flow|TED/TED|This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600-021 (NCT00930644)
201952|NCT01560403|O2|Outcome|TED/TED|This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600 021 (NCT00930644).
201953|NCT01560403|O1|Outcome|NT,PBO/TED|This group represents those subjects who either participated in Study CL0600-020 (NCT00798967) and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension study CL0600-021 (NCT00930644) directly.
201954|NCT01560403|E2|Reported Event|TED/TED|This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600-021 (NCT00930644)
201955|NCT01560403|E1|Reported Event|NT/PBO,TED|This group represents those subjects who either participated in Study CL0600-020 and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension Study CL0600-021 (NCT00930644) directly
201956|NCT01560260|B1|Baseline|Treatment (Linsitinib)|"Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Linsitinib: Given PO~Pharmacological Study: Correlative studies"
201957|NCT01560260|P1|Participant Flow|Treatment (Linsitinib)|"Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Linsitinib: Given PO~Pharmacological Study: Correlative studies"
201958|NCT01560260|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Linsitinib: Given PO~Pharmacological Study: Correlative studies"
201959|NCT01560260|E1|Reported Event|Treatment (Linsitinib)|"Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Linsitinib: Given PO~Pharmacological Study: Correlative studies"
201960|NCT01560234|B9|Baseline|Total|Total of all reporting groups
201961|NCT01560234|B8|Baseline|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
201962|NCT01560234|B7|Baseline|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
201963|NCT01560234|B6|Baseline|Cohort 5|AZD8848 15 μg
201964|NCT01560234|B5|Baseline|Cohort 4|AZD8848 5 μg
201965|NCT01560234|B4|Baseline|Cohort 3|AZD8848 1.5 μg
201966|NCT01560234|B3|Baseline|Cohort 2|AZD8848 0.5 ug
201967|NCT01560234|B2|Baseline|Cohort 1|AZD8848 0.15 μg
201968|NCT01560234|B1|Baseline|Placebo|Commercial 0.9% sodium chloride solution.
201969|NCT01560234|P8|Participant Flow|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
201970|NCT01560234|P7|Participant Flow|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
201971|NCT01560234|P6|Participant Flow|Cohort 5|AZD8848 15 μg
201972|NCT01560234|P5|Participant Flow|Cohort 4|AZD8848 5 μg
201973|NCT01560234|P4|Participant Flow|Cohort 3|AZD8848 1.5 μg
201974|NCT01560234|P3|Participant Flow|Cohort 2|AZD8848 0.5 ug
201975|NCT01560234|P2|Participant Flow|Cohort 1|AZD8848 0.15 μg
201976|NCT01560234|P1|Participant Flow|Placebo|Commercial 0.9% sodium chloride solution.
201977|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
201978|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
201979|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
201980|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
201981|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
201982|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
201983|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
201984|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
201985|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
201986|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
201987|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
201988|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
201989|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
201990|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
201991|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
201992|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
201993|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
201994|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
201995|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
201996|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
201997|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
201998|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
201999|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
202000|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
202001|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
202002|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
202003|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
202004|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
202005|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
202006|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
202007|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
202008|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
202009|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
202010|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
202011|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
202012|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
202013|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
202014|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
202015|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
202016|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
202017|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
202018|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
202019|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
202020|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
202021|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
202022|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
202023|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
202025|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
202026|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
202027|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
202028|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
202029|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
202030|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
202031|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
202032|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
202033|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
202034|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
202035|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
202036|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
202037|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
202038|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
202039|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
202040|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
202041|NCT01560234|E8|Reported Event|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
202042|NCT01560234|E7|Reported Event|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
202043|NCT01560234|E6|Reported Event|Cohort 5|AZD8848 15 μg
202044|NCT01560234|E5|Reported Event|Cohort 4|AZD8848 5 μg
202045|NCT01560234|E4|Reported Event|Cohort 3|AZD8848 1.5 μg
202046|NCT01560234|E3|Reported Event|Cohort 2|AZD8848 0.5 ug
202047|NCT01560234|E2|Reported Event|Cohort 1|AZD8848 0.15 μg
202048|NCT01560234|E1|Reported Event|Placebo|Commercial 0.9% sodium chloride solution.
202049|NCT01560143|B1|Baseline|Tigecycline|"All subjects receive a single dose of tigecycline~Tigecycline: 100 mg IV as a single infusion over 30 minutes"
202050|NCT01560143|P1|Participant Flow|Tigecycline|"All subjects receive a single dose of tigecycline~Tigecycline: 100 mg IV as a single infusion over 30 minutes"
202051|NCT01560143|O1|Outcome|Serum AUC of Tigecycline|"All subjects receive a single dose of tigecycline~Tigecycline: 100 mg IV as a single infusion over 30 minutes"
202052|NCT01560143|E1|Reported Event|Tigecycline|"All subjects receive a single dose of tigecycline~Tigecycline: 100 mg IV as a single infusion over 30 minutes"
202053|NCT01559935|B1|Baseline|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]~Car Phase:~carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.~BiRD Phase:~Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Maintenance Phase:~Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
202054|NCT01559935|P1|Participant Flow|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]~Car Phase:~carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.~BiRD Phase:~Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Maintenance Phase:~Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
202055|NCT01559935|O1|Outcome|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]~Car Phase:~carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.~BiRD Phase:~Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Maintenance Phase:~Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
202056|NCT01559935|O1|Outcome|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]~Car Phase:~carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.~BiRD Phase:~Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Maintenance Phase:~Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
202057|NCT01559935|O1|Outcome|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]~Car Phase:~carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.~BiRD Phase:~Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Maintenance Phase:~Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
202058|NCT01559935|O1|Outcome|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]~Car Phase:~carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.~BiRD Phase:~Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Maintenance Phase:~Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
202059|NCT01559935|O1|Outcome|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]~Car Phase:~carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.~BiRD Phase:~Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Maintenance Phase:~Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
202060|NCT01559935|E1|Reported Event|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]~Car Phase:~carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.~BiRD Phase:~Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Maintenance Phase:~Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
202061|NCT01559922|B3|Baseline|Total|Total of all reporting groups
202062|NCT01559922|B2|Baseline|Artefill|Artefill: Administration of up to 2 study treatments administered 6 weeks apart
202063|NCT01559922|B1|Baseline|Placebo|"Normal Saline~Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart"
202064|NCT01559922|P2|Participant Flow|Artefill|Artefill: Administration of up to 2 study treatments administered 6 weeks apart
202065|NCT01559922|P1|Participant Flow|Placebo|Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart
202066|NCT01559922|O2|Outcome|Artefill|Artefill: Administration of up to 2 study treatments administered 6 weeks apart
202067|NCT01559922|O1|Outcome|Placebo|"Normal Saline~Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart"
202068|NCT01559922|E2|Reported Event|Artefill|Artefill: Administration of up to 2 study treatments administered 6 weeks apart
202069|NCT01559922|E1|Reported Event|Placebo|"Normal Saline~Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart"
202070|NCT01559857|B3|Baseline|Total|Total of all reporting groups
202071|NCT01559857|B2|Baseline|Sugar Pill|"50% of participants will be randomized to 12 weeks of treatment with placebo pill.~Sugar Pill: Placebo"
202072|NCT01559857|B1|Baseline|Pioglitazone|"50% of participants will be allocated to 12 weeks of treatment with 30 mg/day of Pioglitazone.~Pioglitazone: 30mg once daily for 12 weeks"
202073|NCT01559857|P2|Participant Flow|Sugar Pill|"50% of participants will be randomized to 12 weeks of treatment with placebo pill.~Sugar Pill: Placebo"
202074|NCT01559857|P1|Participant Flow|Pioglitazone|"50% of participants will be allocated to 12 weeks of treatment with 30 mg/day of Pioglitazone.~Pioglitazone: 30mg once daily for 12 weeks"
202075|NCT01559857|O4|Outcome|Placebo - IR|Participants who received the sugar pill and were insulin resistant.
202076|NCT01559857|O3|Outcome|Pio - IR|Participants who received pioglitazone and were insulin resistant.
202077|NCT01559857|O2|Outcome|Placebo - IS|Participants who received placebo and were insulin sensitive.
202078|NCT01559857|O1|Outcome|Pio - IS|Participants who received pioglitazone and were insulin sensitive.
202079|NCT01559857|O4|Outcome|Placebo - IR|Participants who received the sugar pill and were insulin resistant.
202080|NCT01559857|O3|Outcome|Pio - IR|Participants who received pioglitazone and were insulin resistant.
202081|NCT01559857|O2|Outcome|Placebo - IS|Participants who received placebo and were insulin sensitive.
202082|NCT01559857|O1|Outcome|Pio - IS|Participants who received pioglitazone and were insulin sensitive.
202083|NCT01559857|O4|Outcome|Placebo - IR|Participants who received the sugar pill and were insulin resistant.
202084|NCT01559857|O3|Outcome|Pio - IR|Participants who received pioglitazone and were insulin resistant.
202085|NCT01559857|O2|Outcome|Placebo - IS|Participants who received placebo and were insulin sensitive.
202086|NCT01559857|O1|Outcome|Pio - IS|Participants who received pioglitazone and were insulin sensitive.
202087|NCT01559857|E2|Reported Event|Sugar Pill|"50% of participants will be randomized to 12 weeks of treatment with placebo pill.~Sugar Pill: Placebo"
202088|NCT01559857|E1|Reported Event|Pioglitazone|"50% of participants will be allocated to 12 weeks of treatment with 30 mg/day of Pioglitazone.~Pioglitazone: 30mg once daily for 12 weeks"
202089|NCT01559844|B1|Baseline|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
202090|NCT01559844|P1|Participant Flow|SOF+RBV|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
202091|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
202092|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
202093|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
202094|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
202095|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
202096|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
202097|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
202098|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
202099|NCT01559844|E1|Reported Event|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
202100|NCT01559675|B3|Baseline|Total|Total of all reporting groups
202101|NCT01559675|B2|Baseline|Low Dose Steroid|"1/3 Intravenous equivalent dose (IVED) at surgical incision, followed by 1/3 IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed~Hydrocortisone: 1/3 IV equivalent dose (IVED) (hydrocortisone equivalent of the patient's preoperative steroid dose) at surgical incision, followed by 1/3 IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD 2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed"
202102|NCT01559675|B1|Baseline|High Dose Steroid|"Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed~Hydrocortisone: Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed"
202103|NCT01559675|P2|Participant Flow|Low Dose Steroid|"1/3 Intravenous equivalent dose (IVED) at surgical incision, followed by 1/3 IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD 2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed~Hydrocortisone: 1/3 IV equivalent dose (IVED) (hydrocortisone equivalent of the patient's preoperative steroid dose) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed"
202104|NCT01559675|P1|Participant Flow|High Dose Steroid|"Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed~Hydrocortisone: Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed"
202105|NCT01559675|O2|Outcome|Low Dose Steroid|"1/3 Intravenous equivalent dose (IVED) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed~Hydrocortisone: 1/3 IV equivalent dose (IVED) (hydrocortisone equivalent of the patient's preoperative steroid dose) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed"
202106|NCT01559675|O1|Outcome|High Dose Steroid|"Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed~Hydrocortisone: Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed"
202107|NCT01559675|E2|Reported Event|Low Dose Steroid|"1/3 Intravenous equivalent dose (IVED) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed~Hydrocortisone: 1/3 IV equivalent dose (IVED) (hydrocortisone equivalent of the patient's preoperative steroid dose) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed"
202149|NCT01559454|E2|Reported Event|Buprenorphine/Naloxone|Buprenorphine 4-16 mg/day divided 2-4 times a day for 6 months
202150|NCT01559454|E1|Reported Event|Methadone|Methadone 10-60 mg/day divided 2-4 times a day for 6 months
202151|NCT01559311|B4|Baseline|Total|Total of all reporting groups
202108|NCT01559675|E1|Reported Event|High Dose Steroid|"Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed~Hydrocortisone: Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed"
202109|NCT01559649|B3|Baseline|Total|Total of all reporting groups
202110|NCT01559649|B2|Baseline|Nurses|Registered nurses working on MEDVAMC stroke wards
202111|NCT01559649|B1|Baseline|Suspected Stroke|Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke.
202112|NCT01559649|P2|Participant Flow|Registered Nurses|Stroke ward nurses. The nurses administered and interpret the swallowing screening items. Speech pathologists made blinded, simultaneous interpretations of the screening items. Nurse and speech pathologist interpretation were used to establish nursing reliability.
202113|NCT01559649|P1|Participant Flow|Patients With Suspected Stroke|Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke recruited. Individuals with a history of neurological disease other than stroke, head and neck structural surgery, or history of dysphagia unrelated to the current stroke were excluded . Individuals who were obtunded, medically unstable, greater than 5 days post-admission were excluded. Patients with language or cognitive deficits who were judged by the attending neurologist to not have capacity to provide informed consent were eligible to participate, but they had to have an authorized representative available within 24 hours of admission to provide consent. Patients underwent swallowing screening and videofluoroscopic swallowing study (VFSS) to establish validity of screening items
202114|NCT01559649|O1|Outcome|Nurses|Only nurses administered and interpreted the screening items.
202115|NCT01559649|O1|Outcome|Nurses|Only nurses administered and interpreted the screening items.
202116|NCT01559649|O2|Outcome|Registered Nurses|Stroke ward nurses
202117|NCT01559649|O1|Outcome|Patients With Suspected Stroke|Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke
202118|NCT01559649|O2|Outcome|Registered Nurses|Stroke ward nurses.
202119|NCT01559649|O1|Outcome|Patients With Suspected Stroke|Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke
202120|NCT01559649|O2|Outcome|Registered Nurses|Stroke ward nurses.
202121|NCT01559649|O1|Outcome|Patients With Suspected Stroke|Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke
202122|NCT01559649|E1|Reported Event|Patients With Suspected Stroke|Individuals admitted with suspected ischemic or hemorrhagic stroke
202123|NCT01559506|B3|Baseline|Total|Total of all reporting groups
202124|NCT01559506|B2|Baseline|Air Barrier System Device|"Device is deployed adjacent to the surgery site and activated.~Air Barrier System device: Device is deployed adjacent to the surgery site and activated."
202125|NCT01559506|B1|Baseline|No Device|Subject does not receive ABS system
202126|NCT01559506|P2|Participant Flow|Air Barrier System Device|"Device is deployed adjacent to the surgery site and activated.~Air Barrier System device: Device is deployed adjacent to the surgery site and activated."
202127|NCT01559506|P1|Participant Flow|No Device|Subject does not receive ABS system
202128|NCT01559506|O2|Outcome|Air Barrier System Device|"Device is deployed adjacent to the surgery site and activated.~Air Barrier System device: Device is deployed adjacent to the surgery site and activated."
202129|NCT01559506|O1|Outcome|No Device|Subject does not receive ABS system
202130|NCT01559506|E2|Reported Event|Air Barrier System Device|"Device is deployed adjacent to the surgery site and activated.~Air Barrier System device: Device is deployed adjacent to the surgery site and activated."
202131|NCT01559506|E1|Reported Event|No Device|Subject does not receive ABS system
202132|NCT01559454|B3|Baseline|Total|Total of all reporting groups
202133|NCT01559454|B2|Baseline|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day~Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
202134|NCT01559454|B1|Baseline|Methadone|"10-60 mg/day divided by 2-4 times a day~Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
202135|NCT01559454|P2|Participant Flow|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day~Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
202136|NCT01559454|P1|Participant Flow|Methadone|"10-60 mg/day divided by 2-4 times a day~Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
202137|NCT01559454|O2|Outcome|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day~Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
202138|NCT01559454|O1|Outcome|Methadone|"10-60 mg/day divided by 2-4 times a day~Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
202139|NCT01559454|O2|Outcome|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day~Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
202140|NCT01559454|O1|Outcome|Methadone|"10-60 mg/day divided by 2-4 times a day~Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
202141|NCT01559454|O2|Outcome|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day~Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
202142|NCT01559454|O1|Outcome|Methadone|"10-60 mg/day divided by 2-4 times a day~Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
202143|NCT01559454|O2|Outcome|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day~Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
202144|NCT01559454|O1|Outcome|Methadone|"10-60 mg/day divided by 2-4 times a day~Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
202145|NCT01559454|O2|Outcome|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day~Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
202146|NCT01559454|O1|Outcome|Methadone|"10-60 mg/day divided by 2-4 times a day~Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
202147|NCT01559454|O2|Outcome|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day~Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
202148|NCT01559454|O1|Outcome|Methadone|"10-60 mg/day divided by 2-4 times a day~Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
202156|NCT01559311|P2|Participant Flow|CRT-P ON|Echo-guided Group – Cardiac resynchronization therapy pacemaker (CRT-P) Standard Therapy
202157|NCT01559311|P1|Participant Flow|CRT-P OFF|Echo-guided Group – Dual chamber pacemaker (DDDR) Standard Therapy
202158|NCT01559311|O3|Outcome|DDDR|Control Group – DDDR Standard Therapy
202159|NCT01559311|O2|Outcome|CRT-P ON|Echo-guided Group – CRT-P Standard Therapy
202160|NCT01559311|O1|Outcome|CRT-P OFF|Echo-guided Group – DDDR Standard Therapy
202161|NCT01559311|O3|Outcome|DDDR|Control Group – DDDR Standard Therapy
202162|NCT01559311|O2|Outcome|CRT-P ON|Echo-guided Group – CRT-P Standard Therapy
202163|NCT01559311|O1|Outcome|CRT-P OFF|Echo-guided Group – DDDR Standard Therapy
202164|NCT01559311|E3|Reported Event|DDDR|Control Group – DDDR Standard Therapy
202165|NCT01559311|E2|Reported Event|CRT-P ON|Echo-guided Group – CRT-P Standard Therapy
202166|NCT01559311|E1|Reported Event|CRT-P OFF|Echo-guided Group – DDDR Standard Therapy
202167|NCT01559116|B1|Baseline|All Subjects|Randomised, double-blind, placebo-controlled, 6 treatment, 4 period, incomplete cross-over trial to characterise the 24-hour lung function profiles of tiotropium + olodaterol fixed dose combination (2.5/5 μg, 5/5 μg), tiotropium (2.5 μg, 5 μg) and olodaterol (5 μg) (oral inhalation, delivered by the Respimat® Inhaler) after 6 weeks once daily treatment in patients with Chronic Obstructive Pulmonary Disease (COPD) [VIVACITOTM].
202168|NCT01559116|P1|Participant Flow|All Subjects|Randomised, double-blind, placebo-controlled, 6 treatment, 4 period, incomplete cross-over trial to characterise the 24-hour lung function profiles of tiotropium + olodaterol fixed dose combination (2.5/5 μg, 5/5 μg), tiotropium (2.5 μg, 5 μg) and olodaterol (5 μg) (oral inhalation, delivered by the Respimat® Inhaler) after 6 weeks once daily treatment in patients with Chronic Obstructive Pulmonary Disease (COPD) [VIVACITOTM].
202169|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202170|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202171|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
202172|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
202173|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202174|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
202175|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202176|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202177|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
202178|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
202179|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202180|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
202181|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202182|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202183|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
202184|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
202185|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202186|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
202187|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202188|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202189|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
202190|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
202191|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202192|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
202193|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202194|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202340|NCT01558674|O2|Outcome|MK-7145 16 mg (Part I:Period 3)|16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
202195|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
202196|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
202197|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202198|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
202199|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202200|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202201|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
202202|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
202203|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202204|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
202205|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202206|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202207|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
202208|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
202209|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202210|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.)
202211|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202212|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202213|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
202214|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
202215|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202216|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
202217|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202218|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202219|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
202220|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
202221|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202222|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
202223|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202224|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202225|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
202226|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
202227|NCT01559116|O2|Outcome|Olodaterol (5 µg)|"Olodaterol solution for inhalation - RESPIMAT~2 oral inhalations once daily in the morning for 6 weeks."
202228|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT:2 Oral inhalations once daily in the morning for 6 weeks.
202229|NCT01559116|E6|Reported Event|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202230|NCT01559116|E5|Reported Event|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202231|NCT01559116|E4|Reported Event|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
202232|NCT01559116|E3|Reported Event|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
202233|NCT01559116|E2|Reported Event|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
202234|NCT01559116|E1|Reported Event|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
202235|NCT01559064|B4|Baseline|Total|Total of all reporting groups
202236|NCT01559064|B3|Baseline|Age Group C|"Subjects over 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
202237|NCT01559064|B2|Baseline|Age Group B|"Subjects 40 to 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
202238|NCT01559064|B1|Baseline|Age Group A|"Subjects 30 to 40 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
202239|NCT01559064|P3|Participant Flow|Age Group C|"Subjects over 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
202240|NCT01559064|P2|Participant Flow|Age Group B|"Subjects 40 to 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
202241|NCT01559064|P1|Participant Flow|Age Group A|"Subjects 30 to 40 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
202242|NCT01559064|O3|Outcome|Age Group C|"Subjects over 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
202243|NCT01559064|O2|Outcome|Age Group B|"Subjects 40 to 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
202244|NCT01559064|O1|Outcome|Age Group A|"Subjects 30 to 40 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
202245|NCT01559064|E3|Reported Event|Age Group C|"Subjects over 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
202246|NCT01559064|E2|Reported Event|Age Group B|"Subjects 40 to 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
202247|NCT01559064|E1|Reported Event|Age Group A|"Subjects 30 to 40 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
202248|NCT01559012|B3|Baseline|Total|Total of all reporting groups
202249|NCT01559012|B2|Baseline|Placebo First - Clonidine Second|"in this group patients are treated with placebo first for 5 days then with TD clonidine for next 5 days~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
202250|NCT01559012|B1|Baseline|Clonidine First - Placebo Second|"in this group patients are treated with TD clonidine first for 5 days then switch to placebo for 5 days~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
202251|NCT01559012|P2|Participant Flow|Placebo First - Clonidine Second|"in this group patients are treated with placebo first for 5 days then with TD clonidine for next 5 days~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
202252|NCT01559012|P1|Participant Flow|Clonidine First - Placebo Second|"in this group patients are treated with TD clonidine first for 5 days then switch to placebo for 5 days~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
202253|NCT01559012|O2|Outcome|Placebo|diastolic blood pressure was recorded every day during placebo cycle
202254|NCT01559012|O1|Outcome|Clonidine|diastolic blood pressure was recorded every day during clonidine treatment cycle
202255|NCT01559012|O2|Outcome|Placebo|systolic blood pressure was recorded during placebo cycle
202256|NCT01559012|O1|Outcome|Clonidine|systolic blood pressure was recorded during clonidine treatment cycle
202257|NCT01559012|O2|Outcome|APGAR Score at 5'|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
202258|NCT01559012|O1|Outcome|APGAR Score at 1'|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
202259|NCT01559012|O1|Outcome|Mean Birth Weight of 12 Patients|"All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round~Allocation order randomized"
202260|NCT01559012|O2|Outcome|Placebo|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
202261|NCT01559012|O1|Outcome|Clonidine|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
202262|NCT01559012|O2|Outcome|Placebo|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
202263|NCT01559012|O1|Outcome|Clonidine|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round.
202264|NCT01559012|O2|Outcome|Placebo|"All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
202265|NCT01559012|O1|Outcome|Clonidine|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
202266|NCT01559012|O2|Outcome|Placebo|"All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round~Allocation order randomized"
202267|NCT01559012|O1|Outcome|Clonidine|"All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round~Allocation order randomized"
202268|NCT01559012|O2|Outcome|Placebo|"in this group patients are treated with placebo first for 5 days then with TD clonidine for next 5 days~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
202269|NCT01559012|O1|Outcome|Clonidine|"in this group patients are treated with TD clonidine first for 5 days then switch to placebo for 5 days~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
202270|NCT01559012|O2|Outcome|Placebo|"Six patients are treated with TD clonidine first,for 5 days, then switch to placebo for next 5 days Other six patients are treated with placebo first, for 5 days, then are switched to TD clonidine for next 5 days.~The allocation order for every patient is randomized~Every patient is the comparison as to herself"
202271|NCT01559012|O1|Outcome|Clonidine|"Six patients are treated with TD clonidine first for 5 days then switch to placebo for next 5 days Other six patients are treated with placebo first, for 5 days, then are switched to TD clonidine for next 5 days.~The allocation order for every patient is randomized.~Every patient is the comparison as to herself"
202272|NCT01559012|E2|Reported Event|Placebo|patients are treated with placebo (sham patch) for 5 days
202273|NCT01559012|E1|Reported Event|Clonidine|patients are treated with transdermal clonidine patch 5 mg for 5 days
202274|NCT01558791|B3|Baseline|Total|Total of all reporting groups
202275|NCT01558791|B2|Baseline|TBI Handout|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.~TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
202276|NCT01558791|B1|Baseline|Screened as Usual|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
202277|NCT01558791|P2|Participant Flow|TBI Handout|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.~TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
202278|NCT01558791|P1|Participant Flow|Screened as Usual|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
202279|NCT01558791|O2|Outcome|Arm 2|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.~TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
202280|NCT01558791|O1|Outcome|Arm 1|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
202281|NCT01558791|O2|Outcome|Arm 2|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.~TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
202282|NCT01558791|O1|Outcome|Arm 1|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
202283|NCT01558791|O2|Outcome|Arm 2|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.~TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
202284|NCT01558791|O1|Outcome|Arm 1|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
202285|NCT01558791|E2|Reported Event|Arm 2|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.~TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
202286|NCT01558791|E1|Reported Event|Arm 1|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
202287|NCT01558739|B1|Baseline|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
202288|NCT01558739|P1|Participant Flow|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
202289|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
202290|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
202291|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
202292|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
202293|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
202294|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
202295|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
202296|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
202297|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
202341|NCT01558674|O1|Outcome|MK-7145 8 mg (Part 1: Period 1)|8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
202298|NCT01558739|E1|Reported Event|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
202299|NCT01558700|B3|Baseline|Total|Total of all reporting groups
202300|NCT01558700|B2|Baseline|Sugar Pill|"Matching capsule given once a day for a total of 17 weeks.~Sugar pill: Matching capsule given once a day for a total of 17 weeks."
202301|NCT01558700|B1|Baseline|Duloxetine|"Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.~Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week."
202302|NCT01558700|P2|Participant Flow|Sugar Pill|"Matching capsule given once a day for a total of 17 weeks.~Sugar pill: Matching capsule given once a day for a total of 17 weeks."
202303|NCT01558700|P1|Participant Flow|Duloxetine|"Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.~Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week."
202304|NCT01558700|O2|Outcome|Sugar Pill|"Matching capsule given once a day for a total of 17 weeks.~Sugar pill: Matching capsule given once a day for a total of 17 weeks."
202305|NCT01558700|O1|Outcome|Duloxetine|"Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.~Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week."
202306|NCT01558700|O2|Outcome|Sugar Pill|"Matching capsule given once a day for a total of 17 weeks.~Sugar pill: Matching capsule given once a day for a total of 17 weeks."
202307|NCT01558700|O1|Outcome|Duloxetine|"Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.~Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week."
202308|NCT01558700|E2|Reported Event|Sugar Pill|"Matching capsule given once a day for a total of 17 weeks.~Sugar pill: Matching capsule given once a day for a total of 17 weeks."
202309|NCT01558700|E1|Reported Event|Duloxetine|"Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.~Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week."
202310|NCT01558674|B3|Baseline|Total|Total of all reporting groups
202311|NCT01558674|B2|Baseline|Furosemide/Torsemide→MK-7145 10 mg→MK-7145 16 mg→MK-7145 24 mg|Part 2: Participants receive Furosemide/Torsemide for 2 weeks , then 10 mg MK-7145 for 14 days, then MK-7145 16 mg for 14 days and then MK-7145 24 mg for 28 days. Each treatment period was separated by a 3-day wash-out.
202312|NCT01558674|B1|Baseline|MK-7145 8 mg→Furosemide 40 mg 2 x Day (BID)→ MK-7145 16 mg|Part 1: Participants receive 8 mg MK-7145 once daily (QD) for 5 days, then furosemide 40 mg BID for 5 days and then 16 mg MK-7145 QD for 5 days. Each treatment period was separated by a 3-day wash-out.
202313|NCT01558674|P2|Participant Flow|Furosemide/Torsemide→MK-7145 10 mg→MK-7145 16 mg→MK-7145 24 mg|Part 2: Participants receive Furosemide/Torsemide for 2 weeks , then 10 mg MK-7145 for 14 days, then MK-7145 16 mg for 14 days and then MK-7145 24 mg for 28 days. Each treatment period was separated by a 3-day wash-out.
202314|NCT01558674|P1|Participant Flow|MK-7145 8 mg→Furosemide 40 mg 2 x Day (BID)→ MK-7145 16 mg|Part 1: Participants receive 8 mg MK-7145 once daily (QD) for 5 days, then furosemide 40 mg BID for 5 days and then 16 mg MK-7145 QD for 5 days. Each treatment period was separated by a 3-day wash-out.
202315|NCT01558674|O3|Outcome|MK-7145 24 mg (Part 2: Period 4)|24 mg of MK-7145 once daily for 28 days
202316|NCT01558674|O2|Outcome|MK-7145 16 mg (Part 2: Period 3)|14 mg of MK-7145 once daily for 14 days
202317|NCT01558674|O1|Outcome|MK-7145 10 mg (Part 2: Period 2)|10 mg of MK-7145 once daily for 14 days
202318|NCT01558674|O3|Outcome|MK-7145 24 mg (Part 2: Period 4)|24 mg of MK-7145 once daily for 28 days
202319|NCT01558674|O2|Outcome|MK-7145 16 mg|14 mg of MK-7145 once daily for 14 days
202320|NCT01558674|O1|Outcome|MK-7145 10 mg (Part 2: Period 2)|10 mg of MK-7145 once daily for 14 days
202321|NCT01558674|O3|Outcome|MK-7145 24 mg (Part 2: Period 4)|24 mg of MK-7145 once daily for 28 days
202322|NCT01558674|O2|Outcome|MK-7145 16 mg|14 mg of MK-7145 once daily for 14 days
202323|NCT01558674|O1|Outcome|MK-7145 10 mg (Part 2: Period 2)|10 mg of MK-7145 once daily for 14 days
202324|NCT01558674|O3|Outcome|MK-7145 24 mg (Part 2: Period 4)|24 mg of MK-7145 once daily for 28 days
202325|NCT01558674|O2|Outcome|MK-7145 16 mg (Part 2: Period 3)|14 mg of MK-7145 once daily for 14 days
202326|NCT01558674|O1|Outcome|MK-7145 10 mg (Part 2: Period 2)|10 mg of MK-7145 once daily for 14 days
202327|NCT01558674|O3|Outcome|MK-7145 24 mg (Part 2: Period 4)|24 mg of MK-7145 once daily for 28 days
202328|NCT01558674|O2|Outcome|MK-7145 16 mg (Part 2: Period 3)|14 mg of MK-7145 once daily for 14 days
202329|NCT01558674|O1|Outcome|MK-7145 10 mg (Part 2: Period 2)|10 mg of MK-7145 once daily for 14 days
202330|NCT01558674|O4|Outcome|MK-7145 24 mg (Part 2: Period 4)|24 mg of MK-7145 once daily for 28 days
202331|NCT01558674|O3|Outcome|MK-7145 16 mg (Part 2: Period 3)|14 mg of MK-7145 once daily for 14 days
202332|NCT01558674|O2|Outcome|MK-7145 10 mg (Part 2:Period 2)|10 mg of MK-7145 once daily for 14 days
202333|NCT01558674|O1|Outcome|Furosemide/Torsemide (Part 2; Period 1)|Stable, clinically optimized maintenance dose regimen of furosemide or torsemide for at least 2 weeks.
202334|NCT01558674|O2|Outcome|MK-7145 16 mg (Part I:Period 3)|16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
202335|NCT01558674|O1|Outcome|MK-7145 8 mg (Part 1: Period 1)|8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
202336|NCT01558674|O2|Outcome|MK-7145 16 mg (Part I:Period 3)|16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
202337|NCT01558674|O1|Outcome|MK-7145 8 mg (Part 1: Period 1)|8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
202338|NCT01558674|O2|Outcome|MK-7145 16 mg (Part I:Period 3)|16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
202339|NCT01558674|O1|Outcome|MK-7145 8 mg (Part 1: Period 1)|8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
203558|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
202342|NCT01558674|O2|Outcome|MK-7145 16 mg (Part I:Period 3)|16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
202343|NCT01558674|O1|Outcome|MK-7145 8 mg (Part 1: Period 1)|8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
202344|NCT01558674|O3|Outcome|MK-7145 16 mg (Part I:Period 3)|16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
202345|NCT01558674|O2|Outcome|Furosemide 40 mg BID (Part 1: Period 2)|40 mg Furosemide tablet BID for 5 days administered in a fasted state
202346|NCT01558674|O1|Outcome|MK-7145 8 mg (Part 1: Period 1)|8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
202347|NCT01558674|O4|Outcome|MK-7145 24 mg (Part 2: Period 4)|24 mg of MK-7145 once daily for 28 days
202348|NCT01558674|O3|Outcome|MK-7145 16 mg (Part 2: Period 3)|14 mg of MK-7145 once daily for 14 days
202349|NCT01558674|O2|Outcome|MK-7145 10 mg (Part 2: Period 2)|10 mg of MK-7145 once daily for 14 days
202350|NCT01558674|O1|Outcome|Furosemide/Torsemide (Part 2; Period 1)|Stable, clinically optimized maintenance dose regimen of furosemide or torsemide for at least 2 weeks.
202351|NCT01558674|O3|Outcome|MK-7145 16 mg (Part 1: Period 3)|16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
202352|NCT01558674|O2|Outcome|Furosemide 40 mg BID (Part 1: Period 2)|40 mg Furosemide tablet BID for 5 days administered in a fasted state
202353|NCT01558674|O1|Outcome|MK-7145 8 mg (Part 1: Period 1)|8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
202354|NCT01558674|E3|Reported Event|Post Trial|Participants who received at least one dose of study drug during Period 1 or 2 of Part 1 of the study
202355|NCT01558674|E2|Reported Event|Furosemide 40 mg (Part 1:Period 2)|Two daily doses of one 40 mg Furosemide tablet for 5 days administered in a fasted state
202356|NCT01558674|E1|Reported Event|MK-7145 8 mg (Part 1:Period 1)|Single daily dose of 8 mg MK-7145 for 5 days, capsules, orally administered in a fasted state
202357|NCT01558661|B1|Baseline|AG-013736 (AXITINIB)|This is a single-arm phase II study evaluating the clinical efficacy of axitinib in the treatment of patients with progressive, recurrent/metastatic adenoid cystic carcinoma (ACC).
202358|NCT01558661|P1|Participant Flow|AG-013736 (AXITINIB)|This is a single-arm phase II study evaluating the clinical efficacy of axitinib in the treatment of patients with progressive, recurrent/metastatic adenoid cystic carcinoma (ACC).
202359|NCT01558661|O1|Outcome|AG-013736 (AXITINIB)|This is a single-arm phase II study evaluating the clinical efficacy of axitinib in the treatment of patients with progressive, recurrent/metastatic adenoid cystic carcinoma (ACC).
202360|NCT01558661|O1|Outcome|AG-013736 (AXITINIB)|This is a single-arm phase II study evaluating the clinical efficacy of axitinib in the treatment of patients with progressive, recurrent/metastatic adenoid cystic carcinoma (ACC).
202361|NCT01558661|O1|Outcome|AG-013736 (AXITINIB)|This is a single-arm phase II study evaluating the clinical efficacy of axitinib in the treatment of patients with progressive, recurrent/metastatic adenoid cystic carcinoma (ACC).
202362|NCT01558661|O1|Outcome|AG-013736 (AXITINIB)|This is a single-arm phase II study evaluating the clinical efficacy of axitinib in the treatment of patients with progressive, recurrent/metastatic adenoid cystic carcinoma (ACC).
202363|NCT01558661|E1|Reported Event|AG-013736 (AXITINIB)|This is a single-arm phase II study evaluating the clinical efficacy of axitinib in the treatment of patients with progressive, recurrent/metastatic adenoid cystic carcinoma (ACC).
202364|NCT01558596|B3|Baseline|Total|Total of all reporting groups
202365|NCT01558596|B2|Baseline|RIPC|"Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion.~Preconditioning: Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion."
202366|NCT01558596|B1|Baseline|Sham|"Blood pressure cuff inflated to 40-50 mmHg in the upper extremity~Control: Blood pressure cuff inflated to 40-50 mmHg in the upper extremity"
202367|NCT01558596|P2|Participant Flow|RIPC|"Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion.~Preconditioning: Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion."
202368|NCT01558596|P1|Participant Flow|Sham|"Blood pressure cuff inflated to 40-50 mmHg in the upper extremity~Control: Blood pressure cuff inflated to 40-50 mmHg in the upper extremity"
202369|NCT01558596|O2|Outcome|RIPC|Blood pressure cuff inflated to 200 mmHg over the brachial artery while confirming absence of radial and ulnar pulse. Total duration of protocol was 30 minutes, equally divided between reperfusion and ischemia.
202370|NCT01558596|O1|Outcome|Sham|Blood pressure cuff inflated to 40-50 mmHg over brachial artery
202371|NCT01558596|E2|Reported Event|RIPC|Blood pressure cuff inflated above systolic blood pressure (200 mmHg) over brachial artery to induce forearm ischemia. Total duration of protocol 30 minutes equally divided between ischemia ( 5 minutes x 3) and reperfusion ( 5 minutes x3)
202372|NCT01558596|E1|Reported Event|Sham|Blood pressure cuff inflated to 40 mmHg to mask controls
202373|NCT01558492|B1|Baseline|All Subjects|"Carboplatin and Paclitaxel~Carboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle~Paclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle"
202374|NCT01558492|P1|Participant Flow|All Subjects|"Carboplatin and Paclitaxel~Carboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle~Paclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle"
202375|NCT01558492|O1|Outcome|All Subjects|"Carboplatin and Paclitaxel~Carboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle~Paclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle"
202376|NCT01558492|O1|Outcome|All Subjects|"Carboplatin and Paclitaxel~Carboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle~Paclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle"
202377|NCT01558492|O1|Outcome|All Subjects|"Carboplatin and Paclitaxel~Carboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle~Paclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle"
202378|NCT01558492|E1|Reported Event|All Subjects|"Carboplatin and Paclitaxel~Carboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle~Paclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle"
202379|NCT01558297|B4|Baseline|Total|Total of all reporting groups
202380|NCT01558297|B3|Baseline|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
202381|NCT01558297|B2|Baseline|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
202382|NCT01558297|B1|Baseline|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
202383|NCT01558297|P3|Participant Flow|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
202384|NCT01558297|P2|Participant Flow|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
202385|NCT01558297|P1|Participant Flow|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
202386|NCT01558297|O3|Outcome|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
202387|NCT01558297|O2|Outcome|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
202388|NCT01558297|O1|Outcome|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
202389|NCT01558297|O3|Outcome|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
202390|NCT01558297|O2|Outcome|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
202391|NCT01558297|O1|Outcome|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
202392|NCT01558297|O3|Outcome|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
202393|NCT01558297|O2|Outcome|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
202394|NCT01558297|O1|Outcome|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
202395|NCT01558297|E3|Reported Event|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
202396|NCT01558297|E2|Reported Event|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
202397|NCT01558297|E1|Reported Event|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
202398|NCT01558271|B4|Baseline|Total|Total of all reporting groups
202399|NCT01558271|B3|Baseline|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
202400|NCT01558271|B2|Baseline|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202401|NCT01558271|B1|Baseline|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202402|NCT01558271|P3|Participant Flow|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
202403|NCT01558271|P2|Participant Flow|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202404|NCT01558271|P1|Participant Flow|LY2189265|Once-weekly subcutaneous (SC) injection of 0.75 milligrams (mg) of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202405|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
202406|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202407|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202408|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
202409|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202410|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202411|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
202412|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202413|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202414|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
202415|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202416|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202417|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
202418|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202419|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202420|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
202421|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202422|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202423|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
202424|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202425|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202426|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
202427|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202428|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202429|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
202430|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202431|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202432|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
202433|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202434|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202435|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
202436|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202437|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202438|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
202439|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202440|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202441|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
202442|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202443|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202444|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
202445|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202446|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202447|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
202448|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202449|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202450|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
202451|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202452|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202453|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
202454|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202455|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202456|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
202457|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202458|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202459|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 24 weeks of open therapy.
202460|NCT01558271|O2|Outcome|Placebo|Once-weekly SC injection of placebo for 26 weeks of blinded therapy.
202461|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy.
202462|NCT01558271|E3|Reported Event|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
202463|NCT01558271|E2|Reported Event|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202464|NCT01558271|E1|Reported Event|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
202465|NCT01558128|B1|Baseline|Amiodarone With Cardioversion|"If subject converts to normal sinus rhythm following amiodarone no further intervention is taken, if subject remains in atrial fibrillation following amiodarone they are cardioverted.~Amiodarone: Bolus given 150mg IV, then IV drip 1mg per hour infused for 6 hours, 0.5mg per hour infused for 18 hours.~Cardioversion: Cardioversion done if atrial fibrillation continues following 24 hour infusion of amiodarone. Cardioversion done following hospital protocol."
202466|NCT01558128|P1|Participant Flow|Amiodarone With Cardioversion|"If subject converts to normal sinus rhythm following amiodarone no further intervention is taken, if subject remains in atrial fibrillation following amiodarone they are cardioverted.~Amiodarone: Bolus given 150mg IV, then IV drip 1mg per hour infused for 6 hours, 0.5mg per hour infused for 18 hours.~Cardioversion: Cardioversion done if atrial fibrillation continues following 24 hour infusion of amiodarone. Cardioversion done following hospital protocol."
202467|NCT01558128|O1|Outcome|Amiodarone With Cardioversion|"If subject converts to normal sinus rhythm following amiodarone no further intervention is taken, if subject remains in atrial fibrillation following amiodarone they are cardioverted.~Amiodarone: Bolus given 150mg IV, then IV drip 1mg per hour infused for 6 hours, 0.5mg per hour infused for 18 hours.~Cardioversion: Cardioversion done if atrial fibrillation continues following 24 hour infusion of amiodarone. Cardioversion done following hospital protocol."
202468|NCT01558128|E1|Reported Event|Amiodarone With Cardioversion|"If subject converts to normal sinus rhythm following amiodarone no further intervention is taken, if subject remains in atrial fibrillation following amiodarone they are cardioverted.~Amiodarone: Bolus given 150mg IV, then IV drip 1mg per hour infused for 6 hours, 0.5mg per hour infused for 18 hours.~Cardioversion: Cardioversion done if atrial fibrillation continues following 24 hour infusion of amiodarone. Cardioversion done following hospital protocol."
202469|NCT01558089|B1|Baseline|ETANERCEPT/ METHOTREXATE|The study group comprised adult patients who at the time of entry had moderate-to-severe rheumatoid arthritis (RΑ), having symptoms for at least 6 weeks and no more than 2 years while satisfying the 2010 RA classification criteria, Disease Activity Score 28 (DAS28) ≥3.2, and who were prescribed for the first time to receive Methotrexate + Etanercept according to routine clinical practice and current summary of product characteristics, prior to enrollment in this study.
202470|NCT01558089|P1|Participant Flow|ETANERCEPT/ METHOTREXATE|The study group comprised adult patients who at the time of entry had moderate-to-severe rheumatoid arthritis (RΑ), having symptoms for at least 6 weeks and no more than 2 years while satisfying the 2010 RA classification criteria, Disease Activity Score 28 (DAS28) ≥3.2, and who were prescribed for the first time to receive Methotrexate + Etanercept according to routine clinical practice and current summary of product characteristics, prior to enrollment in this study.
202471|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
202472|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
202473|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
202474|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
202475|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
202476|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
202477|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
202478|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
202479|NCT01558089|E1|Reported Event|ETANERCEPT/ METHOTREXATE|The study group comprised adult patients who at the time of entry had moderate-to-severe rheumatoid arthritis (RΑ), having symptoms for at least 6 weeks and no more than 2 years while satisfying the 2010 RA classification criteria, Disease Activity Score 28 (DAS28) ≥3.2, and who were prescribed for the first time to receive Methotrexate + Etanercept according to routine clinical practice and current summary of product characteristics, prior to enrollment in this study.
202480|NCT01557959|B1|Baseline|Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)|Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
202481|NCT01557959|P1|Participant Flow|Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)|Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
202482|NCT01557959|O2|Outcome|High Cyclin D1|
202483|NCT01557959|O1|Outcome|Low Cyclin D1|
202484|NCT01557959|O2|Outcome|High Cyclin D1|
202485|NCT01557959|O1|Outcome|Low Cyclin D1|
202486|NCT01557959|O1|Outcome|Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)|Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
202487|NCT01557959|E1|Reported Event|Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)|Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
202488|NCT01557946|B3|Baseline|Total|Total of all reporting groups
202489|NCT01557946|B2|Baseline|Healthy Control|No citalopram tablet taken.
202490|NCT01557946|B1|Baseline|Citalopram 20/40 mg|Citalopram tablet taken once daily.
202491|NCT01557946|P2|Participant Flow|Healthy Control|No citalopram tablet taken.
202492|NCT01557946|P1|Participant Flow|Citalopram 20 mg / 40 mg|"Citalopram tablet taken once daily.~Only applicable to MDD participants. Every subject began on 20 mg, and had the option to titrate up to 40 mg."
202493|NCT01557946|O1|Outcome|Participants With Depression|Participants with depression receiving citalopram
202494|NCT01557946|O1|Outcome|Participants With Depression|Participants with depression receiving citalopram
202495|NCT01557946|E2|Reported Event|Healthy Control|No citalopram tablet taken.
202496|NCT01557946|E1|Reported Event|Citalopram 20 mg / 40 mg|Citalopram tablet taken once daily.
202497|NCT01557920|B1|Baseline|Crossover Randomized Propofol and Sevoflurane|"The healthy subject will be anesthetized with Propofol and Sevoflurane in a randomized crossover fashion. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Spontaneous swallows were identified, and categorized as physiological or pathological. Physiological swallows were followed by expiratory flow (E or I–E). Pathological swallows were followed by inspiration (I and E–I).~Propofol: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump.~Sevoflurane: Sevoflurane will be administered via mask inhalation to achieve anesthesia."
202498|NCT01557920|P2|Participant Flow|Sevoflurane First, Then Propofol|"The healthy subject will be anesthetized first with Sevoflurane, and secondarily with Propofol. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Propofol: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump.~Sevoflurane: Sevoflurane will be administered via mask inhalation to achieve anesthesia."
202499|NCT01557920|P1|Participant Flow|Propofol First, Then Sevoflurane|"The healthy subject will be anesthetized first with Propofol, and secondarily with Sevoflurane. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Propofol: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump.~Sevoflurane: Sevoflurane will be administered via mask inhalation to achieve anesthesia."
202500|NCT01557920|O2|Outcome|Wakefulness|
202501|NCT01557920|O1|Outcome|Anesthesia With Propofol and Sevoflurane|
202502|NCT01557920|O5|Outcome|Anesthesia With High Dose Propofol (CO2 Baseline)|Duty cycle during anesthesia with propofol (during baseline CO2).
202503|NCT01557920|O4|Outcome|Anesthesia With Low Dose Propofol (CO2 Baseline)|Duty cycle during anesthesia with propofol (CO2 baseline).
202504|NCT01557920|O3|Outcome|Anesthesia With High Dose Sevoflurane (Baseline CO2)|Duty cycle during anesthesia with sevoflurane (baseline CO2)
202505|NCT01557920|O2|Outcome|Anesthesia With Low Dose Sevoflurane (Baseline CO2)|Duty cycle during anesthesia with sevoflurane (during baseline CO2).
202506|NCT01557920|O1|Outcome|Wakefulness|Duty cycle (CO2 baseline)
202507|NCT01557920|O5|Outcome|Anesthesia With High Dose Propofol (CO2 Baseline)|Minute Ventilation during anesthesia with propofol (during baseline CO2).
202508|NCT01557920|O4|Outcome|Anesthesia With Low Dose Propofol (CO2 Baseline)|Minute Ventilation during anesthesia with propofol (CO2 baseline).
202509|NCT01557920|O3|Outcome|Anesthesia With High Dose Sevoflurane (Baseline CO2)|Minute ventilation during anesthesia with sevoflurane (baseline CO2)
202510|NCT01557920|O2|Outcome|Anesthesia With Low Dose Sevoflurane (Baseline CO2)|Minute ventilation during anesthesia with sevoflurane (during baseline CO2).
202511|NCT01557920|O1|Outcome|Wakefulness|Minute Ventilation (CO2 baseline)
202512|NCT01557920|O4|Outcome|Tonic Genioglossus Activity (Deep Anesthesia)|Tonic Genioglossus activity (deep anesthesia)
202513|NCT01557920|O3|Outcome|Phasic Genioglossus Activity (Deep Anesthesia)|Phasic activity (Peak activity - Tonic activity)
202514|NCT01557920|O2|Outcome|Tonic Genioglossus Activity (Light Anesthesia)|Tonic Genioglossus activity (light anesthesia)
202515|NCT01557920|O1|Outcome|Phasic Genioglossus Activity (Light Anesthesia)|Phasic activity (Peak activity - Tonic activity)
202516|NCT01557920|O5|Outcome|Anesthesia With High Dose Propofol (CO2 Baseline)|
202517|NCT01557920|O4|Outcome|Anesthesia With Low Dose Propofol (CO2 Baseline)|
202518|NCT01557920|O3|Outcome|Anesthesia With High Dose Sevoflurane (Baseline CO2)|
202519|NCT01557920|O2|Outcome|Anesthesia With Low Dose Sevoflurane (Baseline CO2)|
202520|NCT01557920|O1|Outcome|Wakefulness|
202521|NCT01557920|O6|Outcome|Wakefulness (With CO2 Insufflation)|Proportion of pathological (inspiratory) swallows during wakefulness (with CO2+4 and +8 insufflation).
202522|NCT01557920|O5|Outcome|Wakefulness (During Baseline CO2)|Proportion of pathological (inspiratory) swallows during anesthesia (during baseline CO2).
202523|NCT01557920|O4|Outcome|Anesthesia With Propofol and Sevoflurane (CO2 Insufflation)|Proportion of pathological (inspiratory) swallows during anesthesia (with CO2+4 and +8 insufflation).
202524|NCT01557920|O3|Outcome|Anesthesia With Propofol and Sevoflurane (Baseline CO2)|Proportion of pathological (inspiratory) swallows during anesthesia with propofol and sevoflurane (during baseline CO2).
202525|NCT01557920|O2|Outcome|Wakefulness (All Cases)|Proportion of pathological (inspiratory) swallows during wakefulness (across CO2 levels)
202526|NCT01557920|O1|Outcome|Anesthesia With Propofol and Sevoflurane (All Cases)|Proportion of pathological (inspiratory) swallows during anesthesia with propofol and sevoflurane (across carbon-dioxide (CO2) levels).
202527|NCT01557920|O2|Outcome|Sevoflurane|"The healthy subject will be anesthetized with Sevoflurane. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Sevoflurane: Sevoflurane will be administered via mask inhalation to achieve anesthesia."
202528|NCT01557920|O1|Outcome|Propofol|"The healthy subject will be anesthetized with Propofol. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Propofol: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump."
202529|NCT01557920|E2|Reported Event|Sevoflurane|"The healthy subject will be anesthetized with Sevoflurane. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Sevoflurane: Sevoflurane will be administered via mask inhalation to achieve anesthesia."
202530|NCT01557920|E1|Reported Event|Propofol|"The healthy subject will be anesthetized with Propofol. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Propofol: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump."
202531|NCT01557894|B3|Baseline|Total|Total of all reporting groups
202566|NCT01557842|O2|Outcome|Drug Treatment Group|Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
202532|NCT01557894|B2|Baseline|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
202533|NCT01557894|B1|Baseline|Waitlist Control Group|Wait-list control group
202534|NCT01557894|P2|Participant Flow|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
202535|NCT01557894|P1|Participant Flow|Waitlist Control Group|"Wait-list control group just completed a weekly social anxiety measure (LSAS-SR) for the first 9 weeks.~Starting from week 10 these participants received the active intervention."
202536|NCT01557894|O2|Outcome|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
202537|NCT01557894|O1|Outcome|Waitlist Control Group|Wait-list control group
202538|NCT01557894|O2|Outcome|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
202539|NCT01557894|O1|Outcome|Waitlist Control Group|Wait-list control group
202540|NCT01557894|O2|Outcome|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
202541|NCT01557894|O1|Outcome|Waitlist Control Group|Wait-list control group
202542|NCT01557894|O2|Outcome|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
202543|NCT01557894|O1|Outcome|Waitlist Control Group|Wait-list control group
202544|NCT01557894|O2|Outcome|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
202545|NCT01557894|O1|Outcome|Waitlist Control Group|Wait-list control group just completed a weekly social anxiety measure (LSAS-SR) for the first 9 weeks. Starting from week 10 these participants benefited from the active intervention.
202546|NCT01557894|E2|Reported Event|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
202547|NCT01557894|E1|Reported Event|Waitlist Control Group|Wait-list control group
202548|NCT01557868|B3|Baseline|Total|Total of all reporting groups
202549|NCT01557868|B2|Baseline|Euflexxa (1% Sodium Hyaluronate)|1% sodium hyaluronate: Three 2 cc injections at weekly intervals
202550|NCT01557868|B1|Baseline|Synvisc (Hylan G-F 20)|hylan G-F 20: Three 2 cc injections at weekly intervals
202551|NCT01557868|P2|Participant Flow|Euflexxa (1% Sodium Hyaluronate)|1% sodium hyaluronate: Three 2 cc injections at weekly intervals
202552|NCT01557868|P1|Participant Flow|Synvisc (Hylan G-F 20)|hylan G-F 20: Three 2 cc injections at weekly intervals
202553|NCT01557868|O2|Outcome|Euflexxa (1% Sodium Hyaluronate)|1% sodium hyaluronate: Three 2 cc injections at weekly intervals
202554|NCT01557868|O1|Outcome|Synvisc (Hylan G-F 20)|hylan G-F 20: Three 2 cc injections at weekly intervals
202555|NCT01557868|O2|Outcome|Euflexxa (1% Sodium Hyaluronate)|1% sodium hyaluronate: Three 2 cc injections at weekly intervals
202556|NCT01557868|O1|Outcome|Synvisc (Hylan G-F 20)|hylan G-F 20: Three 2 cc injections at weekly intervals
202557|NCT01557868|E2|Reported Event|Euflexxa (1% Sodium Hyaluronate)|1% sodium hyaluronate: Three 2 cc injections at weekly intervals
202558|NCT01557868|E1|Reported Event|Synvisc (Hylan G-F 20)|hylan G-F 20: Three 2 cc injections at weekly intervals
202559|NCT01557842|B3|Baseline|Total|Total of all reporting groups
202560|NCT01557842|B2|Baseline|Drug Treatment Group|Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
202561|NCT01557842|B1|Baseline|Catheter Ablation Group|Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.
202562|NCT01557842|P2|Participant Flow|Drug Treatment Group|Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
202563|NCT01557842|P1|Participant Flow|Catheter Ablation Group|Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.
202564|NCT01557842|O2|Outcome|Drug Treatment Group|Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
202565|NCT01557842|O1|Outcome|Catheter Ablation Group|Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.
202567|NCT01557842|O1|Outcome|Catheter Ablation Group|Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.
202568|NCT01557842|E2|Reported Event|Drug Treatment Group|Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
202569|NCT01557842|E1|Reported Event|Catheter Ablation Group|Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.
202570|NCT01557751|B1|Baseline|Total Knee Arthroplasty Subjects Who Are Genotyped|"All patients will have whole blood drawn for genotyping, and participate in the various assessments (psychosocial questionnaires, qualitative sensory testing, etc).~Whole blood for genotyping: This study requires genotyping by extracting DNA from blood sample. A blood sample will be drawn once during visit 2 (day of surgery) or any other time prior to that after the signing of informed consent. Four vacutainers of which hold 8.5 mL will be drawn during this time totaling approximately 34 mL of blood which completes the genomic sampling portion of the study."
202571|NCT01557751|P1|Participant Flow|Total Knee Arthroplasty Subjects Who Are Genotyped|"All patients will have whole blood drawn for genotyping, and participate in the various assessments (psychosocial questionnaires, qualitative sensory testing, etc).~Whole blood for genotyping: This study requires genotyping by extracting DNA from blood sample. A blood sample will be drawn once during visit 2 (day of surgery) or any other time prior to that after the signing of informed consent. Four vacutainers of which hold 8.5 mL will be drawn during this time totaling approximately 34 mL of blood which completes the genomic sampling portion of the study."
202572|NCT01557751|O1|Outcome|Total Knee Arthroplasty Subjects Who Are Genotyped|"All patients will have whole blood drawn for genotyping, and participate in the various assessments (psychosocial questionnaires, qualitative sensory testing, etc).~Whole blood for genotyping: This study requires genotyping by extracting DNA from blood sample. A blood sample will be drawn once during visit 2 (day of surgery) or any other time prior to that after the signing of informed consent. Four vacutainers of which hold 8.5 mL will be drawn during this time totaling approximately 34 mL of blood which completes the genomic sampling portion of the study."
202573|NCT01557751|E1|Reported Event|Total Knee Arthroplasty Subjects Who Are Genotyped|"All patients will have whole blood drawn for genotyping, and participate in the various assessments (psychosocial questionnaires, qualitative sensory testing, etc).~Whole blood for genotyping: This study requires genotyping by extracting DNA from blood sample. A blood sample will be drawn once during visit 2 (day of surgery) or any other time prior to that after the signing of informed consent. Four vacutainers of which hold 8.5 mL will be drawn during this time totaling approximately 34 mL of blood which completes the genomic sampling portion of the study."
202574|NCT01557699|B4|Baseline|Total|Total of all reporting groups
202575|NCT01557699|B3|Baseline|Subcutaneous Meales Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
202576|NCT01557699|B2|Baseline|PMV SoloventTM|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
202577|NCT01557699|B1|Baseline|PMV Puffhaler®|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
202578|NCT01557699|P3|Participant Flow|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
202579|NCT01557699|P2|Participant Flow|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
202580|NCT01557699|P1|Participant Flow|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
202581|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
202582|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
202583|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
202584|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
202585|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
202586|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
202587|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
202588|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
202589|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
202590|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
202591|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
202592|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
202593|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
202594|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
202595|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
202596|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
202597|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
202598|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
202599|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
202600|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
202601|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
202602|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
202603|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
202604|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
202605|NCT01557699|O3|Outcome|Subcutaneous Meales Vaccine|Licensed Subcutaneous Measles Vaccine was administered as single dose of 0.5 ml subcutaneously
202606|NCT01557699|O2|Outcome|PMV SoloventTM|Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.
202607|NCT01557699|O1|Outcome|PMV Puffhaler®|Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.
202608|NCT01557699|E3|Reported Event|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml will be given subcutaneously.~N=20"
202609|NCT01557699|E2|Reported Event|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine will be administered via SoloventTM device. A single dose of 10 mg will be used.~N=20"
202610|NCT01557699|E1|Reported Event|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine will be administered via a Puffhaler® device. A single dose of 10 mg will be used.~N=20"
202611|NCT01557595|B1|Baseline|Adults With ADHD|Participants age 19 and older with a diagnosis of ADHD, in a generally healthy medical condition were recruited. Daily bedtime, wake-up time, and compliance diaries were used to assess sleep quality and timing during a baseline observation week and a 2-week intervention period. The Pittsburgh Sleep Quality Index (PSQI) was administered following baseline and intervention. The intervention protocol consisted of use of blue wavelength-blocking glasses and a moderate lighting environment during evening hours.
202612|NCT01557595|P1|Participant Flow|Adults With ADHD|Participants age 19 and older with a diagnosis of ADHD, in a generally healthy medical condition were recruited. Daily bedtime, wake-up time, and compliance diaries were used to assess sleep quality and timing during a baseline observation week and a 2-week intervention period. The Pittsburgh Sleep Quality Index (PSQI) was administered following baseline and intervention. The intervention protocol consisted of use of blue wavelength-blocking glasses and a moderate lighting environment during evening hours.
202613|NCT01557595|O1|Outcome|Adults With ADHD|Participants age 19 and older with a diagnosis of ADHD, in a generally healthy medical condition were recruited.
202614|NCT01557595|E1|Reported Event|Adults With ADHD|Participants age 19 and older with a diagnosis of ADHD, in a generally healthy medical condition were recruited.
202615|NCT01557582|B1|Baseline|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.~Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.~Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
202616|NCT01557582|P1|Participant Flow|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.~Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.~Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
202638|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
202617|NCT01557582|O1|Outcome|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.~Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.~Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
202618|NCT01557582|O1|Outcome|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.~Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.~Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
202619|NCT01557582|O1|Outcome|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.~Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.~Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
202620|NCT01557582|E1|Reported Event|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.~Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.~Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
202621|NCT01557569|B3|Baseline|Total|Total of all reporting groups
202622|NCT01557569|B2|Baseline|Placebo|"Group will receive placebo instead of atomoxetine~placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks."
202623|NCT01557569|B1|Baseline|Atomoxetine|"Group receiving atomoxetine~Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)"
202624|NCT01557569|P2|Participant Flow|Placebo|"Group will receive placebo instead of atomoxetine~placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks."
202625|NCT01557569|P1|Participant Flow|Atomoxetine|"Group receiving atomoxetine~Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)"
202626|NCT01557569|O2|Outcome|Placebo|"Group will receive placebo instead of atomoxetine~placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks."
202627|NCT01557569|O1|Outcome|Atomoxetine|"Group receiving atomoxetine~Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)"
202628|NCT01557569|E2|Reported Event|Placebo|"Group will receive placebo instead of atomoxetine~placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks."
202629|NCT01557569|E1|Reported Event|Atomoxetine|"Group receiving atomoxetine~Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)"
202630|NCT01557504|B3|Baseline|Total|Total of all reporting groups
202631|NCT01557504|B2|Baseline|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
202632|NCT01557504|B1|Baseline|Sitagliptin/Metformin XR Followed by Placebo|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
202633|NCT01557504|P2|Participant Flow|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
202634|NCT01557504|P1|Participant Flow|Sitagliptin/Metformin XR Followed by Placebo|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
202635|NCT01557504|O2|Outcome|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
202636|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
202637|NCT01557504|O2|Outcome|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
202639|NCT01557504|O2|Outcome|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
202640|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
202641|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
202642|NCT01557504|O2|Outcome|Metformin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
202643|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
202644|NCT01557504|O1|Outcome|Metformin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
202645|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
202646|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
202647|NCT01557504|O1|Outcome|Metformin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
202648|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
202649|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
202650|NCT01557504|O1|Outcome|All Treated Participants|All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 9.
202651|NCT01557504|O1|Outcome|All Treated Participants|All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 6.
202652|NCT01557504|O1|Outcome|All Treated Participants|All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 4.
202653|NCT01557504|O1|Outcome|All Treated Participants|All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 2.
202654|NCT01557504|E2|Reported Event|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
202655|NCT01557504|E1|Reported Event|Sitagliptin/Metformin XR Followed by Placebo|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
202656|NCT01557348|B3|Baseline|Total|Total of all reporting groups
202657|NCT01557348|B2|Baseline|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202658|NCT01557348|B1|Baseline|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202659|NCT01557348|P2|Participant Flow|Alternative TNFi|Eligible participants received alternative TNFi treatment as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202660|NCT01557348|P1|Participant Flow|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202661|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202662|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202868|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
202663|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202664|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202665|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202666|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202667|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202668|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202669|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202670|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202671|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi treatment as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202672|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202673|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202674|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202675|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202676|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202677|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202678|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202679|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202680|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202681|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202682|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202683|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202684|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202685|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202686|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202687|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202688|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202689|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202690|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202691|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202692|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202693|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202869|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
202694|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202695|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202696|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202697|NCT01557348|E2|Reported Event|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202698|NCT01557348|E1|Reported Event|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
202699|NCT01557322|B3|Baseline|Total|Total of all reporting groups
202700|NCT01557322|B2|Baseline|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202701|NCT01557322|B1|Baseline|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202702|NCT01557322|P2|Participant Flow|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202703|NCT01557322|P1|Participant Flow|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202704|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202705|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202706|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202707|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202708|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202709|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202710|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202711|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202712|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202870|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
202713|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202714|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202715|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202716|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202717|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202718|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202719|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202720|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202721|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202722|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202723|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202724|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202725|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202726|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202727|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202728|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202729|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202730|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202731|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202732|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202733|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202734|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202735|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202736|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202737|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202738|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202739|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202740|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202741|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202742|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202743|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202744|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202745|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202746|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202747|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202748|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202749|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202750|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202751|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202752|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202753|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202754|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202755|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202756|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202757|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202758|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202759|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202760|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202761|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202762|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202763|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202764|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202765|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202766|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202767|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202768|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202769|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202770|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202771|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202772|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202773|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202774|NCT01557322|E2|Reported Event|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202775|NCT01557322|E1|Reported Event|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
202793|NCT01557166|O2|Outcome|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
202871|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
202776|NCT01557283|B1|Baseline|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
202777|NCT01557283|P1|Participant Flow|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
202778|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
202779|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
202780|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
202781|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
202782|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
202783|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
202784|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
202785|NCT01557283|E1|Reported Event|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
202786|NCT01557166|B3|Baseline|Total|Total of all reporting groups
202787|NCT01557166|B2|Baseline|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
202788|NCT01557166|B1|Baseline|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
202789|NCT01557166|P2|Participant Flow|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
202790|NCT01557166|P1|Participant Flow|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
202791|NCT01557166|O2|Outcome|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
202792|NCT01557166|O1|Outcome|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
203559|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
202794|NCT01557166|O1|Outcome|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
202795|NCT01557166|O2|Outcome|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
202796|NCT01557166|O1|Outcome|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
202797|NCT01557166|O2|Outcome|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
202798|NCT01557166|O1|Outcome|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
202799|NCT01557166|E2|Reported Event|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
202800|NCT01557166|E1|Reported Event|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
202801|NCT01556997|B4|Baseline|Total|Total of all reporting groups
202802|NCT01556997|B3|Baseline|Perindopril Erbumine (PERe)|Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
202803|NCT01556997|B2|Baseline|Amlodipine Besylate (AMLb)|Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks
202804|NCT01556997|B1|Baseline|XOMA 985|"fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)~XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks"
202805|NCT01556997|P3|Participant Flow|Perindopril Erbumine (PERe)|Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
202806|NCT01556997|P2|Participant Flow|Amlodipine Besylate (AMLb)|Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks
202807|NCT01556997|P1|Participant Flow|XOMA 985|"fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)~XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks"
202808|NCT01556997|O3|Outcome|Perindopril Erbumine (PERe)|Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
202809|NCT01556997|O2|Outcome|Amlodipine Besylate (AMLb)|Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks
202810|NCT01556997|O1|Outcome|XOMA 985|"fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)~XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks"
202811|NCT01556997|O3|Outcome|Perindopril Erbumine (PERe)|Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
202812|NCT01556997|O2|Outcome|Amlodipine Besylate (AMLb)|Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks
202813|NCT01556997|O1|Outcome|XOMA 985|"fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)~XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks"
202814|NCT01556997|E3|Reported Event|Perindopril Erbumine (PERe)|Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
202815|NCT01556997|E2|Reported Event|Amlodipine Besylate (AMLb)|Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks
202816|NCT01556997|E1|Reported Event|XOMA 985|"fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)~XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks"
202817|NCT01556932|B1|Baseline|All Participants|"All participants go through Placebo-ABH or ABH-placebo depending on the sequence they were randomized to. Patients are randomized into Placebo-ABH or ABH-Placebo sequence.~Sequence 1:Patients apply Drug A gel topically for 2 minutes at time 0. After 1 hour, if no change or increase in the nausea score alternative treatment will be given Drug B. If the second treatment is ineffective at one hour (total time 2 hours) alternative usual medications will be given Drug A. ABH is Ativan (lorazepam), Benadryl (diphenhydramine), and Haldol.~Sequence 2:Patients will apply Drug B gel topically for 2 minutes at time 0. After 1 hour, if no change or increase in the nausea score alternative treatment will be given Drug A. If the second treatment is ineffective at one hour (total time 2 hours) alternative usual medications will be given Drug B. ABH is Ativan (lorazepam), Benadryl (diphenhydramine), and Haldol."
202818|NCT01556932|P2|Participant Flow|Placebo-ABH Gel|All individuals who are eligible were randomized to a sequence of treatments: either placebo-ABH or ABH-placebo. All participants were on one arm but separate sequences because they started on different drugs. This group started with Placebo first and then went to ABH gel. The randomization list will be generated by the Study Biostatistician.
202819|NCT01556932|P1|Participant Flow|ABH Gel- Placebo|All individuals who are eligible were randomized to a sequence of treatments: either placebo-ABH or ABH-placebo. All participants were on one arm but separate sequences because they started on different drugs. This group started with ABH gel first and then went to Placebo.The randomization list will be generated by the Study Biostatistician.
202820|NCT01556932|O2|Outcome|Placebo|Placebo applied topically for 2 minutes.
202821|NCT01556932|O1|Outcome|ABH Gel|ABH Gel applied topically for 2 minutes.
202822|NCT01556932|E1|Reported Event|Arm A and Arm B|Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes and placebo topically over 2 minutes.
202823|NCT01556906|B1|Baseline|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
202824|NCT01556906|P1|Participant Flow|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
202825|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
203560|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
202826|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
202827|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
202828|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
202829|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
202830|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
202831|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
202832|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
202833|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
202834|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
202835|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
202836|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
202837|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
202838|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
202839|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
202840|NCT01556906|E1|Reported Event|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
202841|NCT01556763|B4|Baseline|Total|Total of all reporting groups
202842|NCT01556763|B3|Baseline|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
202843|NCT01556763|B2|Baseline|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
202844|NCT01556763|B1|Baseline|Placebo|Matching placebo was administered as one capsule per day for 21 days.
202845|NCT01556763|P3|Participant Flow|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
202846|NCT01556763|P2|Participant Flow|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
202847|NCT01556763|P1|Participant Flow|Placebo|Matching placebo was administered as one capsule per day for 21 days.
202848|NCT01556763|O3|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
202849|NCT01556763|O2|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
202850|NCT01556763|O1|Outcome|Placebo|Matching placebo was administered as one capsule per day for 21 days.
202851|NCT01556763|O3|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
202852|NCT01556763|O2|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
202853|NCT01556763|O1|Outcome|Placebo|Matching placebo was administered as one capsule per day for 21 days.
202854|NCT01556763|O3|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
202855|NCT01556763|O2|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
202856|NCT01556763|O1|Outcome|Placebo|Matching placebo was administered as one capsule per day for 21 days.
202857|NCT01556763|O3|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
202858|NCT01556763|O2|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
202859|NCT01556763|O1|Outcome|Placebo|Matching placebo was administered as one capsule per day for 21 days.
202860|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
202861|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
202862|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
202863|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
202864|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
202865|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
202866|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
202867|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
202872|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
202873|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
202874|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
202875|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
202876|NCT01556763|O3|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
202877|NCT01556763|O2|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
202878|NCT01556763|O1|Outcome|Placebo|Matching placebo was administered as one capsule per day for 21 days.
202879|NCT01556763|E3|Reported Event|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
202880|NCT01556763|E2|Reported Event|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
202881|NCT01556763|E1|Reported Event|Placebo|Matching placebo was administered as one capsule per day for 21 days.
202882|NCT01556724|B3|Baseline|Total|Total of all reporting groups
202883|NCT01556724|B2|Baseline|0.1% Ropivacaine|"0.1% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
202884|NCT01556724|B1|Baseline|0.2% Ropivacaine|"0.2% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
202885|NCT01556724|P2|Participant Flow|0.1% Ropivacaine|"0.1% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
202886|NCT01556724|P1|Participant Flow|0.2% Ropivacaine|"0.2% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
202887|NCT01556724|O2|Outcome|0.1% Ropivacaine Infusion in Nerve Block Catheter|0.1% or 0.2% ropivacaine nerve blocks: Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters w
202888|NCT01556724|O1|Outcome|0.2% Ropivacaine Nerve Block (Standard of Care)|0.1% or 0.2% ropivacaine nerve blocks: Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuo
202918|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
202889|NCT01556724|O2|Outcome|0.1% Ropivacaine Infusion in Nerve Block Catheter|0.1% or 0.2% ropivacaine nerve blocks: Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters w
202890|NCT01556724|O1|Outcome|0.2% Ropivacaine Nerve Block (Standard of Care)|0.1% or 0.2% ropivacaine nerve blocks: Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuo
202891|NCT01556724|O2|Outcome|0.1% Ropivacaine Infusion in Nerve Block Catheter|0.1% or 0.2% ropivacaine nerve blocks: Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters w
202892|NCT01556724|O1|Outcome|0.2% Ropivacaine Nerve Block (Standard of Care)|0.1% or 0.2% ropivacaine nerve blocks: Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuo
202893|NCT01556724|O2|Outcome|0.1% Ropivacaine Infusion in Nerve Block Catheter|"0.1% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
202894|NCT01556724|O1|Outcome|0.2% Ropivacaine|"0.2% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
202895|NCT01556724|O2|Outcome|0.1% Ropivacaine|"0.1% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
202919|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
202920|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
202921|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
202896|NCT01556724|O1|Outcome|0.2% Ropivacaine|"0.2% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
202897|NCT01556724|E2|Reported Event|0.1% Ropivacaine Infusion in Nerve Block Catheter|"0.1% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
202898|NCT01556724|E1|Reported Event|0.2% Ropivacaine|"0.2% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
202899|NCT01556633|B3|Baseline|Total|Total of all reporting groups
202900|NCT01556633|B2|Baseline|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance (CLCR) from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
202901|NCT01556633|B1|Baseline|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
202902|NCT01556633|P2|Participant Flow|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
202903|NCT01556633|P1|Participant Flow|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
202904|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
202905|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
202906|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance (CLCR) from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
202907|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
202908|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
202909|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
202910|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
202911|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
202912|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
202913|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
202914|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
202915|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
202916|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
202917|NCT01556633|O1|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
202922|NCT01556633|E2|Reported Event|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance (CLCR) from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
202923|NCT01556633|E1|Reported Event|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
202924|NCT01556594|B4|Baseline|Total|Total of all reporting groups
202925|NCT01556594|B3|Baseline|Group 3|Med dose IN followed by SC injection followed by high dose IN of glucagon
202926|NCT01556594|B2|Baseline|Group 2|Low dose IN followed by med dose IN followed by SC injection followed by high dose IN of glucagon
202927|NCT01556594|B1|Baseline|Group 1|Low dose IN followed by med dose IN followed by SC injection of glucagon
202928|NCT01556594|P3|Participant Flow|Gp 3: Med Dose IN, SC, High Dose IN|Med dose IN followed by SC followed by high dose IN glucagon
202929|NCT01556594|P2|Participant Flow|Gp 2: Low Dose IN, Med Dose IN, SC, High Dose IN|Low dose IN followed by medium dose IN followed by SC followed by high dose IN glucagon
202930|NCT01556594|P1|Participant Flow|Gp 1: Low Dose IN, Med Dose IN, SC|Low dose IN followed by med dose IN followed by SC injection of glucagon
202931|NCT01556594|O4|Outcome|Medium Dose Novel Form'n|Medium dose novel formulation
202932|NCT01556594|O3|Outcome|High Dose Novel Form'n|High dose novel formulation
202933|NCT01556594|O2|Outcome|Low Dose Novel Form'n|Low dose novel formulation
202934|NCT01556594|O1|Outcome|SC Glucagon Injection|SC glucagon injection 1 mg
202935|NCT01556594|O4|Outcome|Medium Dose Novel Form'n|Medium dose novel formulation
202936|NCT01556594|O3|Outcome|High Dose Novel Form'n|high dose novel formulation
202937|NCT01556594|O2|Outcome|Low Dose Novel Form'n|Low dose novel formulation
202938|NCT01556594|O1|Outcome|SC Glucagon Injection|SC glucagon injection 1 mg
202939|NCT01556594|O4|Outcome|Medium Dose Novel Form'n|Medium dose novel formulation
202940|NCT01556594|O3|Outcome|High Dose Novel Form'n|High dose novel formulation
202941|NCT01556594|O2|Outcome|Low Dose Novel Form'n|Low dose novel formulation
202942|NCT01556594|O1|Outcome|SC Glucagon Injection|SC glucagon injection 1 mg
202943|NCT01556594|E4|Reported Event|Medium Dose Novel Form'n|Medium dose novel formulation
202944|NCT01556594|E3|Reported Event|High Dose Novel Form'n|high dose novel formulation
202945|NCT01556594|E2|Reported Event|Low Dose Novel Form'n|Low dose novel formulation
202946|NCT01556594|E1|Reported Event|SC Glucagon Injection|SC glucagon injection 1 mg
202947|NCT01556451|B1|Baseline|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
202948|NCT01556451|P1|Participant Flow|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
202949|NCT01556451|O1|Outcome|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
202950|NCT01556451|O1|Outcome|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
202951|NCT01556451|O1|Outcome|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
202952|NCT01556451|O1|Outcome|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
202953|NCT01556451|E1|Reported Event|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
202954|NCT01556425|B5|Baseline|Total|Total of all reporting groups
202955|NCT01556425|B4|Baseline|Usual Care Control|"This group will receive neither abstinence reinforcement nor VIVITROL injections, but they will be invited to attend the workplace and outpatient drug abuse counseling.~Usual Care Control: Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling."
202956|NCT01556425|B3|Baseline|Opiate Abstinence Reinforcement Only|"This group would receive employment-based opiate abstinence reinforcement, but this group will not receive VIVITROL.~Employment-based opiate abstinence reinforcement: This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour."
202957|NCT01556425|B2|Baseline|VIVITROL&Opiate Abstinence Reinforcement|This group will be offered VIVITROL and will be required to take it to attend the workplace and to maintain maximum pay. This group will also receive employment-based opiate abstinence reinforcement. This contingency will require participants to provide opiate-negative urine samples on M,W, and F to maintain their maximum pay. If a participant in this group provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.
202958|NCT01556425|B1|Baseline|Vivitrol Only|"The VIVITROL group will be offered one injection of VIVITROL every 4 weeks. Participants in the VIVITROL group will be required to take their scheduled injections to work and earn wages. If a participant misses a scheduled VIVITROL injection (more than 3 days from the scheduled date of administration), the participant will not be allowed to work until the injection is accepted. Additionally, missing a scheduled injection will result in a base pay reset from $8 per hour to $1 per hour. After the reset, the participant's base pay will increase by $1/hour to the maximum of $8/hour for every day that the participant works at least 5 minutes.~Vivitrol: Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks."
202959|NCT01556425|P4|Participant Flow|Usual Care Control|"This group will receive neither abstinence reinforcement nor VIVITROL injections, but they will be invited to attend the workplace and outpatient drug abuse counseling.~Usual Care Control: Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling."
202960|NCT01556425|P3|Participant Flow|Opiate Abstinence Reinforcement Only|"This group would receive employment-based opiate abstinence reinforcement, but this group will not receive VIVITROL.~Employment-based opiate abstinence reinforcement: This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour."
202961|NCT01556425|P2|Participant Flow|VIVITROL&Opiate Abstinence Reinforcement|This group will be offered VIVITROL and will be required to take it to attend the workplace and to maintain maximum pay. This group will also receive employment-based opiate abstinence reinforcement. This contingency will require participants to provide opiate-negative urine samples on M,W, and F to maintain their maximum pay. If a participant in this group provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.
202962|NCT01556425|P1|Participant Flow|Vivitrol Only|"The VIVITROL group will be offered one injection of VIVITROL every 4 weeks. Participants in the VIVITROL group will be required to take their scheduled injections to work and earn wages. If a participant misses a scheduled VIVITROL injection (more than 3 days from the scheduled date of administration), the participant will not be allowed to work until the injection is accepted. Additionally, missing a scheduled injection will result in a base pay reset from $8 per hour to $1 per hour. After the reset, the participant's base pay will increase by $1/hour to the maximum of $8/hour for every day that the participant works at least 5 minutes.~Vivitrol: Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks."
202963|NCT01556425|O4|Outcome|Usual Care Control|"This group will receive neither abstinence reinforcement nor VIVITROL injections, but they will be invited to attend the workplace and outpatient drug abuse counseling.~Usual Care Control: Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling."
202964|NCT01556425|O3|Outcome|Opiate Abstinence Reinforcement Only|"This group would receive employment-based opiate abstinence reinforcement, but this group will not receive VIVITROL.~Employment-based opiate abstinence reinforcement: This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour."
202965|NCT01556425|O2|Outcome|VIVITROL&Opiate Abstinence Reinforcement|This group will be offered VIVITROL and will be required to take it to attend the workplace and to maintain maximum pay. This group will also receive employment-based opiate abstinence reinforcement. This contingency will require participants to provide opiate-negative urine samples on M,W, and F to maintain their maximum pay. If a participant in this group provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.
202966|NCT01556425|O1|Outcome|Vivitrol Only|"The VIVITROL group will be offered one injection of VIVITROL every 4 weeks. Participants in the VIVITROL group will be required to take their scheduled injections to work and earn wages. If a participant misses a scheduled VIVITROL injection (more than 3 days from the scheduled date of administration), the participant will not be allowed to work until the injection is accepted. Additionally, missing a scheduled injection will result in a base pay reset from $8 per hour to $1 per hour. After the reset, the participant's base pay will increase by $1/hour to the maximum of $8/hour for every day that the participant works at least 5 minutes.~Vivitrol: Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks."
202967|NCT01556425|O4|Outcome|Usual Care Control|"This group will receive neither abstinence reinforcement nor VIVITROL injections, but they will be invited to attend the workplace and outpatient drug abuse counseling.~Usual Care Control: Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling."
202968|NCT01556425|O3|Outcome|Opiate Abstinence Reinforcement Only|"This group would receive employment-based opiate abstinence reinforcement, but this group will not receive VIVITROL.~Employment-based opiate abstinence reinforcement: This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour."
202969|NCT01556425|O2|Outcome|VIVITROL&Opiate Abstinence Reinforcement|This group will be offered VIVITROL and will be required to take it to attend the workplace and to maintain maximum pay. This group will also receive employment-based opiate abstinence reinforcement. This contingency will require participants to provide opiate-negative urine samples on M,W, and F to maintain their maximum pay. If a participant in this group provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.
203009|NCT01556061|P2|Participant Flow|D-MAC First, Then CMAC Video Laryngoscopy|D-MAC video laryngoscope (Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
202970|NCT01556425|O1|Outcome|Vivitrol Only|"The VIVITROL group will be offered one injection of VIVITROL every 4 weeks. Participants in the VIVITROL group will be required to take their scheduled injections to work and earn wages. If a participant misses a scheduled VIVITROL injection (more than 3 days from the scheduled date of administration), the participant will not be allowed to work until the injection is accepted. Additionally, missing a scheduled injection will result in a base pay reset from $8 per hour to $1 per hour. After the reset, the participant's base pay will increase by $1/hour to the maximum of $8/hour for every day that the participant works at least 5 minutes.~Vivitrol: Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks."
202971|NCT01556425|E4|Reported Event|Usual Care Control|"This group will receive neither abstinence reinforcement nor VIVITROL injections, but they will be invited to attend the workplace and outpatient drug abuse counseling.~Usual Care Control: Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling."
202972|NCT01556425|E3|Reported Event|Opiate Abstinence Reinforcement Only|"This group would receive employment-based opiate abstinence reinforcement, but this group will not receive VIVITROL.~Employment-based opiate abstinence reinforcement: This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour."
202973|NCT01556425|E2|Reported Event|VIVITROL&Opiate Abstinence Reinforcement|This group will be offered VIVITROL and will be required to take it to attend the workplace and to maintain maximum pay. This group will also receive employment-based opiate abstinence reinforcement. This contingency will require participants to provide opiate-negative urine samples on M,W, and F to maintain their maximum pay. If a participant in this group provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.
202974|NCT01556425|E1|Reported Event|Vivitrol Only|"The VIVITROL group will be offered one injection of VIVITROL every 4 weeks. Participants in the VIVITROL group will be required to take their scheduled injections to work and earn wages. If a participant misses a scheduled VIVITROL injection (more than 3 days from the scheduled date of administration), the participant will not be allowed to work until the injection is accepted. Additionally, missing a scheduled injection will result in a base pay reset from $8 per hour to $1 per hour. After the reset, the participant's base pay will increase by $1/hour to the maximum of $8/hour for every day that the participant works at least 5 minutes.~Vivitrol: Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks."
202975|NCT01556204|B3|Baseline|Total|Total of all reporting groups
202976|NCT01556204|B2|Baseline|Laparoscopic|Laparoscopic surgery
202977|NCT01556204|B1|Baseline|Robotic|Robotic surgery
202978|NCT01556204|P2|Participant Flow|Laparoscopy|"Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
202979|NCT01556204|P1|Participant Flow|Robotic Surgery|"da Vinci Surgical System~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
202980|NCT01556204|O2|Outcome|Laparoscopy|"Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
202981|NCT01556204|O1|Outcome|Robotic Surgery|"da Vinci Surgical System~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
203043|NCT01555567|B5|Baseline|Total|Total of all reporting groups
203103|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
202982|NCT01556204|O2|Outcome|Laparoscopy|"Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
202983|NCT01556204|O1|Outcome|Robotic Surgery|"da Vinci Surgical System~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
202984|NCT01556204|E2|Reported Event|Laparoscopy|"Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect or will be fulgurized using bipolar energy; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
202985|NCT01556204|E1|Reported Event|Robotic Surgery|"da Vinci Surgical System~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect or will be fulgurized using bipolar energy; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
202986|NCT01556165|B3|Baseline|Total|Total of all reporting groups
202987|NCT01556165|B2|Baseline|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
202988|NCT01556165|B1|Baseline|Placebo|placebo: tablets, once daily, orally
202989|NCT01556165|P2|Participant Flow|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
202990|NCT01556165|P1|Participant Flow|Placebo|placebo: tablets, once daily, orally
202991|NCT01556165|O2|Outcome|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
202992|NCT01556165|O1|Outcome|Placebo|placebo: tablets, once daily, orally
202993|NCT01556165|O2|Outcome|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
202994|NCT01556165|O1|Outcome|Placebo|placebo: tablets, once daily, orally
202995|NCT01556165|O2|Outcome|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
202996|NCT01556165|O1|Outcome|Placebo|placebo: tablets, once daily, orally
202997|NCT01556165|O2|Outcome|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
202998|NCT01556165|O1|Outcome|Placebo|placebo: tablets, once daily, orally
202999|NCT01556165|E2|Reported Event|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
203000|NCT01556165|E1|Reported Event|Placebo|placebo: tablets, once daily, orally
203001|NCT01556100|B1|Baseline|18F-DTBZ AV-133|"18F-DTBZ AV-133 imaging~18F-DTBZ AV-133: A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test."
203002|NCT01556100|P1|Participant Flow|18F-DTBZ AV-133|"18F-DTBZ AV-133 imaging~18F-DTBZ AV-133: A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test."
203003|NCT01556100|O1|Outcome|18F-DTBZ AV-133|"18F-DTBZ AV-133 imaging~18F-DTBZ AV-133: A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test."
203004|NCT01556100|O1|Outcome|18F-DTBZ AV-133|"18F-DTBZ AV-133 imaging~18F-DTBZ AV-133: A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test."
203005|NCT01556100|E1|Reported Event|18F-DTBZ AV-133|"18F-DTBZ AV-133 imaging~18F-DTBZ AV-133: A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test."
203006|NCT01556061|B3|Baseline|Total|Total of all reporting groups
203007|NCT01556061|B2|Baseline|D-MAC First, Then C-MAC Video Laryngoscopy|D-MAC video laryngoscope (Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
203008|NCT01556061|B1|Baseline|C-MAC First, Then DMAC Video Laryngoscopy|C-MAC video laryngoscope (Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
203155|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
203010|NCT01556061|P1|Participant Flow|C-MAC First, Then DMAC Video Laryngoscopy|C-MAC video laryngoscope (Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
203011|NCT01556061|O2|Outcome|D-MAC Video Laryngoscopy|D-MAC video laryngoscope (C-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
203012|NCT01556061|O1|Outcome|C-MAC Video Laryngoscopy|C-MAC video laryngoscope (D-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
203013|NCT01556061|O2|Outcome|D-MAC Video Laryngoscopy|D-MAC video laryngoscope (C-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
203014|NCT01556061|O1|Outcome|C-MAC Video Laryngoscopy|C-MAC video laryngoscope (D-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
203015|NCT01556061|O2|Outcome|D-MAC Laryngoscopy First, Then C-MAC Video Laryngoscopy|D-MAC video laryngoscope (C-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
203016|NCT01556061|O1|Outcome|C-MAC Laryngoscopy First, Then DMAC Video Laryngoscopy|C-MAC video laryngoscope (D-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
203017|NCT01556061|E2|Reported Event|DMAC Laryngoscopy First, Then C-MAC Video Laryngoscopy|D-MAC video laryngoscope (C-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
203018|NCT01556061|E1|Reported Event|C-MAC Laryngoscopy First, Then DMAC Video Laryngoscopy|C-MAC video laryngoscope (D-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
203019|NCT01555983|B1|Baseline|All Study Participants|All participants received all interventions
203020|NCT01555983|P6|Participant Flow|6.7%THC First, Then 2.9%THC, Then Placebo|6.7%THC in am of first intervention visit, then 2.9%THC in am of second intervention visit (after 3-10 day washout period) and then placebo in am of third intervention visit (after 3-10 day washout period).
203021|NCT01555983|P5|Participant Flow|6.7%THC First, Then Placebo, Then 2.9%THC|6.7%THC in am of first intervention visit, then placebo in am of second intervention visit (after 3-10 day washout period) and then 2.9%THC in am of third intervention visit (after 3-10 day washout period).
203022|NCT01555983|P4|Participant Flow|2.9%THC First, Then 6.7%THC, Then Placebo|2.9%THC in am of first intervention visit, then 6.7%THC in am of second intervention visit (after 3-10 day washout period) and then placebo in am of third intervention visit (after 3-10 day washout period).
203023|NCT01555983|P3|Participant Flow|2.9%THC First, Then Placebo, Then 6.7%THC|2.9%THC in am of first intervention visit, placebo in am of second intervention visit (after 3-10 day washout period) and then 6.7%THC am of third intervention visit (after 3-10 day washout period)
203024|NCT01555983|P2|Participant Flow|Placebo First, Then 6.7%THC, Then 2.9%THC|Placebo in am of first intervention visit, 6.7%THC in am of second intervention visit (after 3-10 day washout period) and then 2.9%THC in am of third intervention visit (after 3-10 day washout period).
203025|NCT01555983|P1|Participant Flow|Placebo First, Then 2.9%THC, Then 6.7% THC|Placebo in am of first intervention visit, 2.9%THC in am of second intervention visit (after 3-10 day washout period) and then 6.7%THC in am of third intervention visit (after 3-10 day washout period).
203026|NCT01555983|O3|Outcome|6.7% THC|Vaporization of Cannabis 6.7% THC
203027|NCT01555983|O2|Outcome|2.9% THC|Vaporization of Cannabis 2.9% THC
203028|NCT01555983|O1|Outcome|Placebo THC|Session at which placebo THC was administered
203029|NCT01555983|E3|Reported Event|6.7% THC|Vaporization of Cannabis 6.7% THC
203030|NCT01555983|E2|Reported Event|2.9% THC|Vaporization of Cannabis 2.9% THC
203031|NCT01555983|E1|Reported Event|Placebo THC|Vaporization of Cannabis Placebo THC
203032|NCT01555931|B3|Baseline|Total|Total of all reporting groups
203033|NCT01555931|B2|Baseline|Control|"Placement 4-8 weeks after delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
203034|NCT01555931|B1|Baseline|Immediate|"Placement within 48 hours of delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
203035|NCT01555931|P2|Participant Flow|Control|"Placement 4-8 weeks after delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
203036|NCT01555931|P1|Participant Flow|Immediate|"Placement within 48 hours of delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
203037|NCT01555931|O2|Outcome|Control|"Placement 4-8 weeks after delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
203038|NCT01555931|O1|Outcome|Immediate|"Placement within 48 hours of delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
203039|NCT01555931|O2|Outcome|Control|"Placement 4-8 weeks after delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
203040|NCT01555931|O1|Outcome|Immediate|"Placement within 48 hours of delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
203041|NCT01555931|E2|Reported Event|Control|"Placement 4-8 weeks after delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
203042|NCT01555931|E1|Reported Event|Immediate|"Placement within 48 hours of delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
203044|NCT01555567|B4|Baseline|Combination of NMES and Eccentric Exercise|"Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
203045|NCT01555567|B3|Baseline|Eccentric Exercise|"Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr.~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
203046|NCT01555567|B2|Baseline|Standard of Care|This group will undergo standard ACL rehabilitation
203047|NCT01555567|B1|Baseline|Neuromuscular Electrical Stimulation|"Subjects placed into this group will undergo NMES following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week"
203048|NCT01555567|P4|Participant Flow|Combination of NMES and Eccentric Exercise|"Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
203049|NCT01555567|P3|Participant Flow|Eccentric Exercise|"Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr.~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
203050|NCT01555567|P2|Participant Flow|Standard of Care|This group will undergo standard ACL rehabilitation
203051|NCT01555567|P1|Participant Flow|Neuromuscular Electrical Stimulation|"Subjects placed into this group will undergo neuromuscular electrical stimulation (NMES) following anterior cruciate ligament (ACLr). Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week"
203052|NCT01555567|O4|Outcome|Combination of NMES and Eccentric Exercise|"Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
203053|NCT01555567|O3|Outcome|Eccentric Exercise|"Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr.~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
203054|NCT01555567|O2|Outcome|Standard of Care|This group will undergo standard ACL rehabilitation
203055|NCT01555567|O1|Outcome|Neuromuscular Electrical Stimulation|"Subjects placed into this group will undergo NMES following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week"
203056|NCT01555567|O4|Outcome|Combination of NMES and Eccentric Exercise|"Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
203057|NCT01555567|O3|Outcome|Eccentric Exercise|"Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr.~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
203058|NCT01555567|O2|Outcome|Standard of Care|This group will undergo standard ACL rehabilitation
203059|NCT01555567|O1|Outcome|Neuromuscular Electrical Stimulation|"Subjects placed into this group will undergo NMES following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week"
203060|NCT01555567|E4|Reported Event|Combination of NMES and Eccentric Exercise|"Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
203102|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
203061|NCT01555567|E3|Reported Event|Eccentric Exercise|"Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr.~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
203062|NCT01555567|E2|Reported Event|Standard of Care|This group will undergo standard ACL rehabilitation
203063|NCT01555567|E1|Reported Event|Neuromuscular Electrical Stimulation|"Subjects placed into this group will undergo NMES following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week"
203064|NCT01555463|B3|Baseline|Total|Total of all reporting groups
203065|NCT01555463|B2|Baseline|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
203066|NCT01555463|B1|Baseline|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
203067|NCT01555463|P2|Participant Flow|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
203068|NCT01555463|P1|Participant Flow|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
203069|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
203070|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
203071|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
203072|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
203073|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
203074|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
203075|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
203076|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
203077|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
203078|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
203079|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
203080|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
203081|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
203082|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
203083|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
203084|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
203085|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
203086|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
203087|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
203088|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
203089|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
203090|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
203091|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
203092|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
203093|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
203094|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
203095|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
203096|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
203097|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
203098|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
203099|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
203100|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
203101|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
203293|NCT01554176|B3|Baseline|Total|Total of all reporting groups
203104|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
203105|NCT01555463|E2|Reported Event|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
203106|NCT01555463|E1|Reported Event|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
203107|NCT01555164|B3|Baseline|Total|Total of all reporting groups
203108|NCT01555164|B2|Baseline|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.~Participants were required to maintain their diet and exercise regimen."
203109|NCT01555164|B1|Baseline|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.~Participants were required to maintain their diet and exercise regimen."
203110|NCT01555164|P2|Participant Flow|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.~Participants were required to maintain their diet and exercise regimen."
203111|NCT01555164|P1|Participant Flow|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.~Participants were required to maintain their diet and exercise regimen."
203112|NCT01555164|O2|Outcome|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.~Participants were required to maintain their diet and exercise regimen."
203113|NCT01555164|O1|Outcome|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.~Participants were required to maintain their diet and exercise regimen."
203114|NCT01555164|O2|Outcome|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.~Participants were required to maintain their diet and exercise regimen."
203115|NCT01555164|O1|Outcome|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.~Participants were required to maintain their diet and exercise regimen."
203116|NCT01555164|O2|Outcome|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.~Participants were required to maintain their diet and exercise regimen."
203117|NCT01555164|O1|Outcome|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.~Participants were required to maintain their diet and exercise regimen."
203561|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
203118|NCT01555164|E2|Reported Event|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.~Participants were required to maintain their diet and exercise regimen."
203119|NCT01555164|E1|Reported Event|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.~Participants were required to maintain their diet and exercise regimen."
203120|NCT01555151|B5|Baseline|Total|Total of all reporting groups
203121|NCT01555151|B4|Baseline|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
203122|NCT01555151|B3|Baseline|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
203123|NCT01555151|B2|Baseline|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
203124|NCT01555151|B1|Baseline|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
203125|NCT01555151|P4|Participant Flow|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
203126|NCT01555151|P3|Participant Flow|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
203127|NCT01555151|P2|Participant Flow|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
203128|NCT01555151|P1|Participant Flow|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
203129|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
203130|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
203131|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
203132|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
203133|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
203134|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
203135|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
203136|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
203137|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
203138|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
203139|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
203140|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
203141|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
203142|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
203143|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
203144|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
203145|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
203146|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
203147|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
203148|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
203149|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
203150|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
203151|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
203152|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
203153|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
203154|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
203156|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
203157|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
203158|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
203159|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
203160|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
203161|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
203162|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
203163|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
203164|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
203165|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
203166|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
203167|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
203168|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
203169|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
203170|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
203171|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
203172|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
203173|NCT01555151|E5|Reported Event|Total|Total
203174|NCT01555151|E4|Reported Event|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
203175|NCT01555151|E3|Reported Event|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
203176|NCT01555151|E2|Reported Event|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
203177|NCT01555151|E1|Reported Event|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
203178|NCT01555138|B3|Baseline|Total|Total of all reporting groups
203179|NCT01555138|B2|Baseline|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
203180|NCT01555138|B1|Baseline|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
203181|NCT01555138|P2|Participant Flow|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
203182|NCT01555138|P1|Participant Flow|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
203183|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
203184|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
203185|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
203186|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
203187|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
203188|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
203189|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
203190|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
203191|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
203192|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
203193|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
203194|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
203195|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
203196|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
203197|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
203198|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
203199|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
203200|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
203201|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
203202|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
203203|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
203204|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
203205|NCT01555138|E2|Reported Event|Salmeterol/Fluticasone|Salmeterol 50 μg /fluticasone propionate 500 μg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
203206|NCT01555138|E1|Reported Event|Indacaterol|Indacaterol 150 μg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
203207|NCT01555073|B5|Baseline|Total|Total of all reporting groups
203208|NCT01555073|B4|Baseline|Placebo Group|"Placebo group, two placebo tablets day of surgery and twice a day for 13 days~Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days"
203209|NCT01555073|B3|Baseline|Celecoxib/Placebo Group|"celecoxib/placebo twice a day for 13 days.~celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days."
203210|NCT01555073|B2|Baseline|Pregabalin/Placebo Group|"pregabalin/placebo twice a day for 13 days.~pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days."
203211|NCT01555073|B1|Baseline|Pregabalin/Celecoxib Group|"pregabalin/celecoxib twice a day for 13 days.~pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days."
203212|NCT01555073|P4|Participant Flow|Placebo Group|"Placebo group, two placebo tablets day of surgery and twice a day for 13 days~Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days"
203213|NCT01555073|P3|Participant Flow|Celecoxib/Placebo Group|"celecoxib/placebo twice a day for 13 days.~celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days."
203214|NCT01555073|P2|Participant Flow|Pregabalin/Placebo Group|"pregabalin/placebo twice a day for 13 days.~pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days."
203215|NCT01555073|P1|Participant Flow|Pregabalin/Celecoxib Group|"pregabalin/celecoxib twice a day for 13 days.~pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days."
203216|NCT01555073|O4|Outcome|Placebo Group|"Placebo group, two placebo tablets day of surgery and twice a day for 13 days~Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days"
203217|NCT01555073|O3|Outcome|Celecoxib/Placebo Group|"celecoxib/placebo twice a day for 13 days.~celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days."
203218|NCT01555073|O2|Outcome|Pregabalin/Placebo Group|"pregabalin/placebo twice a day for 13 days.~pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days."
203219|NCT01555073|O1|Outcome|Pregabalin/Celecoxib Group|"pregabalin/celecoxib twice a day for 13 days.~pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days."
203220|NCT01555073|O4|Outcome|Placebo Group|"Placebo group, two placebo tablets day of surgery and twice a day for 13 days~Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days"
203221|NCT01555073|O3|Outcome|Celecoxib/Placebo Group|"celecoxib/placebo twice a day for 13 days.~celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days."
203222|NCT01555073|O2|Outcome|Pregabalin/Placebo Group|"pregabalin/placebo twice a day for 13 days.~pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days."
203223|NCT01555073|O1|Outcome|Pregabalin/Celecoxib Group|"pregabalin/celecoxib twice a day for 13 days.~pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days."
203224|NCT01555073|E4|Reported Event|Placebo Group|"Placebo group, two placebo tablets day of surgery and twice a day for 13 days~Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days"
203225|NCT01555073|E3|Reported Event|Celecoxib/Placebo Group|"celecoxib/placebo twice a day for 13 days.~celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days."
203226|NCT01555073|E2|Reported Event|Pregabalin/Placebo Group|"pregabalin/placebo twice a day for 13 days.~pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days."
203227|NCT01555073|E1|Reported Event|Pregabalin/Celecoxib Group|"pregabalin/celecoxib twice a day for 13 days.~pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days."
203228|NCT01554982|B1|Baseline|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
203229|NCT01554982|P1|Participant Flow|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
203230|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
203231|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
203232|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
203233|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
203234|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
203235|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
203236|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
203237|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
203238|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
203239|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
203240|NCT01554982|E1|Reported Event|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
203241|NCT01554904|B1|Baseline|Facial-Flex|Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.
203242|NCT01554904|P1|Participant Flow|Facial-Flex|Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.
203243|NCT01554904|O1|Outcome|Facial-Flex|Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.
203244|NCT01554904|O1|Outcome|Facial-Flex|Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.
203245|NCT01554904|E1|Reported Event|Facial-Flex|Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.
203246|NCT01554891|B4|Baseline|Total|Total of all reporting groups
203247|NCT01554891|B3|Baseline|Sensitivity and Specificity of SAFE-TBI|200 participants in WRNMMC and Fort Belvoir Community Hospital Brain Indices Study (100 with mild TBI; 100 without mild TBI).
203248|NCT01554891|B2|Baseline|Comparison of SAFE-TBI and VA Screen|100 OEF/OIF/OND veterans seeking care at Northern New England VA Research Consortium (NNEVARC) VA Medical Centers (VAMCs) who screen positive for TBI on VA Level 1 TBI screen
203249|NCT01554891|B1|Baseline|Test-Retest Reliability of SAFE-TBI|100 OEF/OIF/OND veterans returning to Joint Base Lewis-McChord and Fort Bragg who screen positive for TBI on the Post Deployment Health Assessment (PDHA) TBI screen
203250|NCT01554891|P3|Participant Flow|Sensitivity and Specificity of SAFE-TBI|200 participants in WRNMMC and Fort Belvoir Community Hospital Brain Indices Study (100 with mild TBI; 100 without mild TBI).
203251|NCT01554891|P2|Participant Flow|Comparison of SAFE-TBI and VA Screen|"100 OEF/OIF/OND veterans seeking care at Northern New England VA Research Consortium (NNEVARC) VA Medical Centers (VAMCs) who screen positive for TBI on VA Level 1 TBI screen This component of the project assessed the correlation of the VA TBI Level 1 screen with the SAFE-TBI.~Participants were OEF/OIF/OND veterans (seeking care at the Northern New England VA Research Consortium [NNEVARC]) that screen positive for TBI on the VA screen when seeking treatment at the VA. Prior to the second level in-depth TBI evaluation, they were interviewed by a TRC using SAFE-TBI."
203294|NCT01554176|B2|Baseline|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
203252|NCT01554891|P1|Participant Flow|Test-Retest Reliability of SAFE-TBI|"100 OEF/OIF/OND veterans returning to Joint Base Lewis-McChord and Fort Bragg who screen positive for TBI on the Post Deployment Health Assessment (PDHA) TBI screen.~This component of the project assessed test-retest reliability (4-6 weeks), as well as the eﬀects of diﬀerent raters; Research Coordinators (TRCs) vs. experienced TBI Clinicians (TBICs) at the Madigan Army Medical Center (MAMC) TBI Clinic. Cohort 1 included subjects recently returned from deployment in Iraq or Afghanistan to Joint Base Lewis-McChord or veterans served at the White River Junction and Togus VAMC who screened positive for TBI on the PDHA. After the initial interview, the SAFE-TBI will be administered for the second time 4-6 weeks later. Participants were assigned to one of four assessment paradigms (i. TRC time 1 and TBIC time 2; ii. TRC time 1 and TRC time 2; iii. TBIC time 1 and TBIC time 2; or iv. TBIC time 1 and TRC time 2)."
203253|NCT01554891|O1|Outcome|Sensitivity and Specificity of SAFE-TBI|Sensitivity = True Positives/(True Positive + False Negatives) Specificity = True Negatives/(True Negative + False Positives)
203254|NCT01554891|O1|Outcome|Comparison of SAFE-TBI and VA Screen|Veterans
203255|NCT01554891|O1|Outcome|Test-Retest Reliability of SAFE-TBI|Cohort 1 was used to determine test-retest reliability of the SAFE-TBI instrument.
203256|NCT01554891|E3|Reported Event|Sensitivity and Specificity of SAFE-TBI|200 participants in WRNMMC and Fort Belvoir Community Hospital Brain Indices Study (100 with mild TBI; 100 without mild TBI).
203257|NCT01554891|E2|Reported Event|Comparison of SAFE-TBI and VA Screen|"100 OEF/OIF/OND veterans seeking care at Northern New England VA Research Consortium (NNEVARC) VA Medical Centers (VAMCs) who screen positive for TBI on VA Level 1 TBI screen This component of the project assessed the correlation of the VA TBI Level 1 screen with the SAFE-TBI.~Participants were OEF/OIF/OND veterans (seeking care at the Northern New England VA Research Consortium [NNEVARC]) that screen positive for TBI on the VA screen when seeking treatment at the VA. Prior to the second level in-depth TBI evaluation, they were interviewed by a TRC using SAFE-TBI."
203258|NCT01554891|E1|Reported Event|Test-Retest Reliability of SAFE-TBI|"100 OEF/OIF/OND veterans returning to Joint Base Lewis-McChord and Fort Bragg who screen positive for TBI on the Post Deployment Health Assessment (PDHA) TBI screen.~This component of the project assessed test-retest reliability (4-6 weeks), as well as the eﬀects of diﬀerent raters; Research Coordinators (TRCs) vs. experienced TBI Clinicians (TBICs) at the Madigan Army Medical Center (MAMC) TBI Clinic. Cohort 1 included subjects recently returned from deployment in Iraq or Afghanistan to Joint Base Lewis-McChord or veterans served at the White River Junction and Togus VAMC who screened positive for TBI on the PDHA. After the initial interview, the SAFE-TBI will be administered for the second time 4-6 weeks later. Participants were assigned to one of four assessment paradigms (i. TRC time 1 and TBIC time 2; ii. TRC time 1 and TRC time 2; iii. TBIC time 1 and TBIC time 2; or iv. TBIC time 1 and TRC time 2)."
203259|NCT01554579|B3|Baseline|Total|Total of all reporting groups
203260|NCT01554579|B2|Baseline|Gefapixant|Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
203261|NCT01554579|B1|Baseline|Sugar Pill|Sugar Pill: Placebo
203262|NCT01554579|P2|Participant Flow|Gefapixant|Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
203263|NCT01554579|P1|Participant Flow|Sugar Pill|Sugar Pill: Placebo Subjects in the trial received one tablet twice daily for 4 weeks.
203264|NCT01554579|O2|Outcome|Gefapixant|Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
203265|NCT01554579|O1|Outcome|Sugar Pill|Sugar Pill: Placebo
203266|NCT01554579|O2|Outcome|Gefapixant|Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
203267|NCT01554579|O1|Outcome|Sugar Pill|Sugar Pill: Placebo
203268|NCT01554579|O2|Outcome|Gefapixant|Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
203269|NCT01554579|O1|Outcome|Sugar Pill|Sugar Pill: Placebo Subjects in the trial received one tablet twice daily for 4 weeks.
203270|NCT01554579|E2|Reported Event|Gefapixant|Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
203271|NCT01554579|E1|Reported Event|Sugar Pill|Sugar Pill: Placebo Subjects in the trial received one tablet twice daily for 4 weeks.
203272|NCT01554241|B5|Baseline|Total|Total of all reporting groups
203273|NCT01554241|B4|Baseline|50,000 IU/Week D3|"D3 50,000 IU weekly~D3 50,000 IU weekly: vitamin D3 50,000 IU/week"
203274|NCT01554241|B3|Baseline|Vitamin D3 4000 IU/Day|"D3 4000 IU/day~D3 4000 IU/day: vitamin D3 4000 IU/day"
203275|NCT01554241|B2|Baseline|2000 IU/Day D3|"D3 2000 IU/day~D3 2000 IU/day: 2000 IU/day D3"
203276|NCT01554241|B1|Baseline|Vitamin D3 800 IU/Day|"recommended daily dosage of 800 IU/day D3~vitamin D3 800 IU/day: vitamin D3 800 IU/day"
203277|NCT01554241|P4|Participant Flow|50,000 IU/Week D3|"D3 50,000 IU weekly~D3 50,000 IU weekly: vitamin D3 50,000 IU/week"
203278|NCT01554241|P3|Participant Flow|Vitamin D3 4000 IU/Day|"D3 4000 IU/day~D3 4000 IU/day: vitamin D3 4000 IU/day"
203279|NCT01554241|P2|Participant Flow|2000 IU/Day D3|"D3 2000 IU/day~D3 2000 IU/day: 2000 IU/day D3"
203280|NCT01554241|P1|Participant Flow|Vitamin D3 800 IU/Day|"recommended daily dosage of 800 IU/day D3~vitamin D3 800 IU/day: vitamin D3 800 IU/day"
203281|NCT01554241|O4|Outcome|50,000 IU/Week D3|"D3 50,000 IU weekly~D3 50,000 IU weekly: vitamin D3 50,000 IU/week"
203282|NCT01554241|O3|Outcome|Vitamin D3 4000 IU/Day|"D3 4000 IU/day~D3 4000 IU/day: vitamin D3 4000 IU/day"
203283|NCT01554241|O2|Outcome|2000 IU/Day D3|"D3 2000 IU/day~D3 2000 IU/day: 2000 IU/day D3"
203284|NCT01554241|O1|Outcome|Vitamin D3 800 IU/Day|"recommended daily dosage of 800 IU/day D3~vitamin D3 800 IU/day: vitamin D3 800 IU/day"
203285|NCT01554241|O4|Outcome|50,000 IU/Week D3|"D3 50,000 IU weekly~D3 50,000 IU weekly: vitamin D3 50,000 IU/week"
203286|NCT01554241|O3|Outcome|Vitamin D3 4000 IU/Day|"D3 4000 IU/day~D3 4000 IU/day: vitamin D3 4000 IU/day"
203287|NCT01554241|O2|Outcome|2000 IU/Day D3|"D3 2000 IU/day~D3 2000 IU/day: 2000 IU/day D3"
203288|NCT01554241|O1|Outcome|Vitamin D3 800 IU/Day|"recommended daily dosage of 800 IU/day D3~vitamin D3 800 IU/day: vitamin D3 800 IU/day"
203289|NCT01554241|E4|Reported Event|50,000 IU/Week D3|"D3 50,000 IU weekly~D3 50,000 IU weekly: vitamin D3 50,000 IU/week"
203290|NCT01554241|E3|Reported Event|Vitamin D3 4000 IU/Day|"D3 4000 IU/day~D3 4000 IU/day: vitamin D3 4000 IU/day"
203291|NCT01554241|E2|Reported Event|2000 IU/Day D3|"D3 2000 IU/day~D3 2000 IU/day: 2000 IU/day D3"
203292|NCT01554241|E1|Reported Event|Vitamin D3 800 IU/Day|"recommended daily dosage of 800 IU/day D3~vitamin D3 800 IU/day: vitamin D3 800 IU/day"
203295|NCT01554176|B1|Baseline|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
203296|NCT01554176|P5|Participant Flow|Placebo/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
203297|NCT01554176|P4|Participant Flow|Filorexant 10 mg/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
203298|NCT01554176|P3|Participant Flow|Filorexant 10 mg/Filorexant 10 mg (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
203299|NCT01554176|P2|Participant Flow|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
203300|NCT01554176|P1|Participant Flow|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
203301|NCT01554176|O3|Outcome|Placebo/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
203302|NCT01554176|O2|Outcome|Filorexant 10 mg/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
203303|NCT01554176|O1|Outcome|Filorexant 10 mg/Filorexant 10 mg (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
203304|NCT01554176|O3|Outcome|Placebo/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
203305|NCT01554176|O2|Outcome|Filorexant 10 mg/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
203306|NCT01554176|O1|Outcome|Filorexant 10 mg/Filorexant 10 mg (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
203307|NCT01554176|O2|Outcome|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
203308|NCT01554176|O1|Outcome|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
203309|NCT01554176|O2|Outcome|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
203310|NCT01554176|O1|Outcome|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
203311|NCT01554176|O2|Outcome|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
203312|NCT01554176|O1|Outcome|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
203313|NCT01554176|O2|Outcome|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
203314|NCT01554176|O1|Outcome|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
203315|NCT01554176|O2|Outcome|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
203316|NCT01554176|O1|Outcome|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
203317|NCT01554176|O2|Outcome|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
203318|NCT01554176|O1|Outcome|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
203319|NCT01554176|E5|Reported Event|Placebo/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the treatment phase.
203320|NCT01554176|E4|Reported Event|Filorexant 10 mg/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
203321|NCT01554176|E3|Reported Event|Filorexant 10 mg/Filorexant 10 mg (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
203322|NCT01554176|E2|Reported Event|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
203323|NCT01554176|E1|Reported Event|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
203324|NCT01554163|B3|Baseline|Total|Total of all reporting groups
203325|NCT01554163|B2|Baseline|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
203326|NCT01554163|B1|Baseline|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
203327|NCT01554163|P2|Participant Flow|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
203328|NCT01554163|P1|Participant Flow|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
203329|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
203330|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
203331|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
203332|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
203333|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
203334|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
203335|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
203336|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
203337|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
203338|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
203339|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
203340|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
203341|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
203342|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
203343|NCT01554163|E2|Reported Event|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
203344|NCT01554163|E1|Reported Event|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
203345|NCT01553916|B1|Baseline|Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation|"Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.~PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium."
203346|NCT01553916|P1|Participant Flow|Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation|"Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.~PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium."
203347|NCT01553916|O1|Outcome|Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation|"Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.~PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium."
203348|NCT01553916|O1|Outcome|Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation|"Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.~PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium."
203349|NCT01553916|O1|Outcome|Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation|"Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.~PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium."
203350|NCT01553916|O1|Outcome|Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation|"Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.~PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium."
203351|NCT01553916|O1|Outcome|Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation|"Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.~PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium."
203352|NCT01553916|O1|Outcome|Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation|"Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.~PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium."
203353|NCT01553916|O1|Outcome|Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation|"Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.~PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium."
203354|NCT01553916|O1|Outcome|Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation|"Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.~PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium."
203355|NCT01553916|O1|Outcome|Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation|"Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.~PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium."
203356|NCT01553916|O1|Outcome|Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation|"Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.~PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium."
203357|NCT01553916|E1|Reported Event|Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation|"Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.~PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium."
203389|NCT01553318|B1|Baseline|Ketotifen Group|Participants who received the active drug - ketotifen
203390|NCT01553318|P2|Participant Flow|Placebo|Placebo medication
203391|NCT01553318|P1|Participant Flow|Ketotifen|ketotifen active group
203358|NCT01553851|B1|Baseline|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
203359|NCT01553851|P1|Participant Flow|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
203360|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
203361|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
203362|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
203363|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
203364|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
203365|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
203366|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
203367|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
203368|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
203369|NCT01553851|E1|Reported Event|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
203370|NCT01553708|B3|Baseline|Total|Total of all reporting groups
203371|NCT01553708|B2|Baseline|Silver Zinc Sulfadiazine Cream|
203372|NCT01553708|B1|Baseline|Epidermal Growth Factor With Silver Sulfadiazine Cream|
203373|NCT01553708|P2|Participant Flow|Silver Zinc Sulfadiazine Cream|
203374|NCT01553708|P1|Participant Flow|Epidermal Growth Factor With Silver Sulfadiazine Cream|
203375|NCT01553708|O2|Outcome|Silver Zinc Sulfadiazine Cream|Wounds treated with the cream containing silver sulfadiazine evenly and covered with sterile gauze. Wounds were also cleaned with sterile normal saline daily and the cream was applied again after cleaning.
203376|NCT01553708|O1|Outcome|Epidermal Growth Factor With Silver Sulfadiazine Cream|Wounds treated with the cream containing epidermal growth factor and silver sulfadiazine evenly and covered with sterile gauze. Wounds were also cleaned with sterile normal saline daily and the cream was applied again after cleaning.
203377|NCT01553708|E2|Reported Event|Silver Zinc Sulfadiazine Cream|
203378|NCT01553708|E1|Reported Event|Epidermal Growth Factor With Silver Sulfadiazine Cream|
203379|NCT01553539|B1|Baseline|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
203380|NCT01553539|P1|Participant Flow|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) subcutaneous (SC) once daily in the absence of disease progression or unacceptable toxicity.
203381|NCT01553539|O1|Outcome|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
203382|NCT01553539|O1|Outcome|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
203383|NCT01553539|O1|Outcome|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
203384|NCT01553539|O1|Outcome|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
203385|NCT01553539|O1|Outcome|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
203386|NCT01553539|E1|Reported Event|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
203387|NCT01553318|B3|Baseline|Total|Total of all reporting groups
203388|NCT01553318|B2|Baseline|Placebo|Participants who received the placebo
203402|NCT01553292|B1|Baseline|Angiocath Surfactant|Preterm infants born at 24 to 34 weeks of postmenstrual gestational age were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
203403|NCT01553292|P1|Participant Flow|Surfactant Through Vascular Catheter|Preterm infants born between 24 to 34 weeks postmenstrual gestation were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)during 1st 24 hours of life
203404|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
203405|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
203406|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
203407|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
203408|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
203409|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
203410|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
203411|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
203412|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants between 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
203413|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
203414|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
203415|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants born between 24 to 34 weeks post-menstrual age were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
203416|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
203417|NCT01553292|E1|Reported Event|Angiocath Surfactant|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
203418|NCT01553240|B1|Baseline|TMS and fMRI|"functional MRI~single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)~TMS and functional MRI (Magstim): single and paired pulse low frequency TMS. 3T structural MRI scans, amplitude modulated continuous arterial spin labeling( CASL) perfusion imaging sequence optimized for 3T is employed for perfusion MR scans using GE FAIR sequence for parallel imaging."
203419|NCT01553240|P1|Participant Flow|TMS and fMRI|"functional MRI~single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)~TMS and functional MRI (Magstim): single and paired pulse low frequency TMS. 3T structural MRI scans, amplitude modulated continuous arterial spin labeling( CASL) perfusion imaging sequence optimized for 3T is employed for perfusion MR scans using GE FAIR sequence for parallel imaging."
203420|NCT01553240|O1|Outcome|TMS and fMRI|"functional MRI~single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)~TMS and functional MRI (Magstim): single and paired pulse low frequency TMS. 3T structural MRI scans, amplitude modulated continuous arterial spin labeling( CASL) perfusion imaging sequence optimized for 3T is employed for perfusion MR scans using GE FAIR sequence for parallel imaging."
203421|NCT01553240|O1|Outcome|TMS and fMRI|"functional MRI~single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)~TMS and functional MRI (Magstim): single and paired pulse low frequency TMS. 3T structural MRI scans, amplitude modulated continuous arterial spin labeling( CASL) perfusion imaging sequence optimized for 3T is employed for perfusion MR scans using GE FAIR sequence for parallel imaging."
203422|NCT01553240|E1|Reported Event|TMS and fMRI|"functional MRI~single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)~TMS and functional MRI (Magstim): single and paired pulse low frequency TMS. 3T structural MRI scans, amplitude modulated continuous arterial spin labeling( CASL) perfusion imaging sequence optimized for 3T is employed for perfusion MR scans using GE FAIR sequence for parallel imaging."
203423|NCT01553136|B3|Baseline|Total|Total of all reporting groups
203424|NCT01553136|B2|Baseline|Varenicline|Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
203425|NCT01553136|B1|Baseline|Sugar Pill|Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
203426|NCT01553136|P2|Participant Flow|Sugar Pill|Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
203427|NCT01553136|P1|Participant Flow|Varenicline|Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
203428|NCT01553136|O2|Outcome|Placebo|Placebo: once per day for Days 1 to 3, twice per day for the remaining days
203429|NCT01553136|O1|Outcome|Varenicline|Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
203430|NCT01553136|O2|Outcome|Placebo|Placebo: once per day for Days 1 to 3, twice per day for the remaining days
203431|NCT01553136|O1|Outcome|Varenicline|Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
203432|NCT01553136|O2|Outcome|Placebo|Placebo: once per day for Days 1 to 3, twice per day for the remaining days
203433|NCT01553136|O1|Outcome|Varenicline|Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
203434|NCT01553136|O2|Outcome|Placebo|Placebo: once per day for Days 1 to 3, twice per day for the remaining days
203435|NCT01553136|O1|Outcome|Varenicline|Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
203436|NCT01553136|O2|Outcome|Placebo|Placebo: once per day for Days 1 to 3, twice per day for the remaining days
203437|NCT01553136|O1|Outcome|Varenicline|Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
203438|NCT01553136|E2|Reported Event|Sugar Pill|Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
203439|NCT01553136|E1|Reported Event|Varenicline|Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
203440|NCT01553058|B4|Baseline|Total|Total of all reporting groups
203441|NCT01553058|B3|Baseline|NB-UVB Phototherapy|"NB-UVB Phototherapy 3 times per week, no other intervention.~NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types."
203442|NCT01553058|B2|Baseline|Placebo Injection|"Injection of placebo in place of active Humira injection.~Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator."
203443|NCT01553058|B1|Baseline|Adalimumab (Humira)|"Injection of the active drug Humira.~Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule."
203444|NCT01553058|P3|Participant Flow|NB-UVB Phototherapy|"NB-UVB Phototherapy 3 times per week, no other intervention.~NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types."
203445|NCT01553058|P2|Participant Flow|Placebo Injection|"Injection of placebo in place of active Humira injection.~Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator."
203446|NCT01553058|P1|Participant Flow|Adalimumab (Humira)|"Injection of the active drug Humira.~Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule."
203447|NCT01553058|O3|Outcome|NB-UVB Phototherapy|NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
203448|NCT01553058|O2|Outcome|Placebo Injection|Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.
203449|NCT01553058|O1|Outcome|Adalimumab (Humira)|Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.
203450|NCT01553058|O3|Outcome|NB-UVB Phototherapy|NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
203451|NCT01553058|O2|Outcome|Placebo Injection|Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.
203452|NCT01553058|O1|Outcome|Adalimumab (Humira)|Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.
203453|NCT01553058|O3|Outcome|NB-UVB Phototherapy|NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
203454|NCT01553058|O2|Outcome|Placebo Injection|Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.
203455|NCT01553058|O1|Outcome|Adalimumab (Humira)|Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.
203456|NCT01553058|O3|Outcome|NB-UVB Phototherapy|NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
203457|NCT01553058|O2|Outcome|Placebo Injection|Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.
203458|NCT01553058|O1|Outcome|Adalimumab (Humira)|Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.
203459|NCT01553058|O3|Outcome|NB-UVB Phototherapy|NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
203460|NCT01553058|O2|Outcome|Placebo Injection|Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.
203461|NCT01553058|O1|Outcome|Adalimumab (Humira)|Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.
203462|NCT01553058|O3|Outcome|NB-UVB Phototherapy|NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
203463|NCT01553058|O2|Outcome|Placebo Injection|Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.
203464|NCT01553058|O1|Outcome|Adalimumab (Humira)|Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.
203465|NCT01553058|O3|Outcome|NB-UVB Phototherapy|NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
203466|NCT01553058|O2|Outcome|Placebo Injection|Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.
203467|NCT01553058|O1|Outcome|Adalimumab (Humira)|Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.
203468|NCT01553058|O3|Outcome|NB-UVB Phototherapy|NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
203469|NCT01553058|O2|Outcome|Placebo Injection|Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.
203470|NCT01553058|O1|Outcome|Adalimumab (Humira)|Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.
203471|NCT01553058|O3|Outcome|NB-UVB Phototherapy|NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
203472|NCT01553058|O2|Outcome|Placebo Injection|njection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.
203473|NCT01553058|O1|Outcome|Adalimumab (Humira)|Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.
203474|NCT01553058|O3|Outcome|NB-UVB Phototherapy|NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
203475|NCT01553058|O2|Outcome|Placebo Injection|Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.
203476|NCT01553058|O1|Outcome|Adalimumab (Humira)|Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.
203477|NCT01553058|O3|Outcome|NB-UVB Phototherapy|"NB-UVB Phototherapy 3 times per week, no other intervention.~NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types."
203478|NCT01553058|O2|Outcome|Placebo Injection|"Injection of placebo in place of active Humira injection.~Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator."
203479|NCT01553058|O1|Outcome|Adalimumab (Humira)|"Injection of the active drug Humira.~Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule."
203480|NCT01553058|O3|Outcome|NB-UVB Phototherapy|"NB-UVB Phototherapy 3 times per week, no other intervention.~NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types."
203481|NCT01553058|O2|Outcome|Placebo Injection|"Injection of placebo in place of active Humira injection.~Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator."
203482|NCT01553058|O1|Outcome|Adalimumab (Humira)|"Injection of the active drug Humira.~Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule."
203483|NCT01553058|O3|Outcome|NB-UVB Phototherapy|"NB-UVB Phototherapy 3 times per week, no other intervention.~NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types."
203484|NCT01553058|O2|Outcome|Placebo Injection|"Injection of placebo in place of active Humira injection.~Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator."
203485|NCT01553058|O1|Outcome|Adalimumab (Humira)|"Injection of the active drug Humira.~Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule."
203486|NCT01553058|O3|Outcome|NB-UVB Phototherapy|"NB-UVB Phototherapy 3 times per week, no other intervention.~NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types."
203487|NCT01553058|O2|Outcome|Placebo Injection|"Injection of placebo in place of active Humira injection.~Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator."
203488|NCT01553058|O1|Outcome|Adalimumab (Humira)|"Injection of the active drug Humira.~Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule."
203489|NCT01553058|O3|Outcome|NB-UVB Phototherapy|"NB-UVB Phototherapy 3 times per week, no other intervention.~NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types."
203490|NCT01553058|O2|Outcome|Placebo Injection|"Injection of placebo in place of active Humira injection.~Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator."
203491|NCT01553058|O1|Outcome|Adalimumab (Humira)|"Injection of the active drug Humira.~Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule."
203492|NCT01553058|O3|Outcome|NB-UVB Phototherapy|"NB-UVB Phototherapy 3 times per week, no other intervention.~NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types."
203493|NCT01553058|O2|Outcome|Placebo Injection|"Injection of placebo in place of active Humira injection.~Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator."
203494|NCT01553058|O1|Outcome|Adalimumab (Humira)|"Injection of the active drug Humira.~Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule."
203495|NCT01553058|O3|Outcome|NB-UVB Phototherapy|NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
203496|NCT01553058|O2|Outcome|Placebo Injection|Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.
203497|NCT01553058|O1|Outcome|Adalimumab (Humira)|Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.
203498|NCT01553058|O3|Outcome|NB-UVB Phototherapy|"NB-UVB Phototherapy 3 times per week, no other intervention.~NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types."
203499|NCT01553058|O2|Outcome|Placebo Injection|"Injection of placebo in place of active Humira injection.~Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator."
203500|NCT01553058|O1|Outcome|Adalimumab (Humira)|"Injection of the active drug Humira.~Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule."
203501|NCT01553058|E3|Reported Event|NB-UVB Phototherapy|"NB-UVB Phototherapy 3 times per week, no other intervention.~NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types."
203502|NCT01553058|E2|Reported Event|Placebo Injection|"Injection of placebo in place of active Humira injection.~Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator."
203503|NCT01553058|E1|Reported Event|Adalimumab (Humira)|"Injection of the active drug Humira.~Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule."
203504|NCT01552954|B3|Baseline|Total|Total of all reporting groups
203505|NCT01552954|B2|Baseline|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.~Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
203506|NCT01552954|B1|Baseline|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
203507|NCT01552954|P2|Participant Flow|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.~Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
203508|NCT01552954|P1|Participant Flow|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
203509|NCT01552954|O2|Outcome|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.~Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
203510|NCT01552954|O1|Outcome|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
203511|NCT01552954|O2|Outcome|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.~Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
203512|NCT01552954|O1|Outcome|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
203513|NCT01552954|O2|Outcome|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.~Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
203514|NCT01552954|O1|Outcome|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
203515|NCT01552954|O2|Outcome|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.~Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
203516|NCT01552954|O1|Outcome|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
203517|NCT01552954|E2|Reported Event|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.~Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
203518|NCT01552954|E1|Reported Event|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
203519|NCT01552928|B5|Baseline|Total|Total of all reporting groups
203520|NCT01552928|B4|Baseline|Placebo, Then Anag 0.5 mg, Then Mox 400 mg, Then Anag 2.5 mg|A single oral dose of placebo on Day 1 for Period 1; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 3; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 4.
203521|NCT01552928|B3|Baseline|Mox 400 mg, Then Placebo, Then Anag 2.5 mg, Then Anag 0.5 mg|A single oral dose of 400 mg of moxifloxacin on Day 1 for Period 1; then a single oral dose of placebo on Day 1 for Period 2; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 4.
203522|NCT01552928|B2|Baseline|Anag 2.5 mg, Then Mox 400 mg, Then Anag 0.5 mg, Then Placebo|A single oral dose of 2.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 2; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of placebo on Day 1 for Period 4.
203523|NCT01552928|B1|Baseline|Anag 0.5 mg, Then Anag 2.5 mg, Then Placebo, Then Mox 400 mg|A single oral dose of 0.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of placebo on Day 1 for Period 3; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 4.
203524|NCT01552928|P4|Participant Flow|Placebo, Then Anag 0.5 mg, Then Mox 400 mg, Then Anag 2.5 mg|A single oral dose of placebo on Day 1 for Period 1; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 3; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 4.
203525|NCT01552928|P3|Participant Flow|Mox 400 mg, Then Placebo, Then Anag 2.5 mg, Then Anag 0.5 mg|A single oral dose of 400 mg of moxifloxacin on Day 1 for Period 1; then a single oral dose of placebo on Day 1 for Period 2; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 4.
203526|NCT01552928|P2|Participant Flow|Anag 2.5 mg, Then Mox 400 mg, Then Anag 0.5 mg, Then Placebo|A single oral dose of 2.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 2; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of placebo on Day 1 for Period 4.
203527|NCT01552928|P1|Participant Flow|Anag 0.5 mg, Then Anag 2.5 mg, Then Placebo, Then Mox 400 mg|A single oral dose of 0.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of placebo on Day 1 for Period 3; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 4.
203528|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
203529|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
203530|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
203531|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
203532|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
203533|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
203534|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
203535|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
203536|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
203537|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
203538|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
203539|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
203540|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
203541|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
203542|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
203543|NCT01552928|O2|Outcome|BCH24426 (Females)|Metabolite from a single oral dose of 2.5 mg of anagrelide
203544|NCT01552928|O1|Outcome|BCH24426 (Males)|Metabolite from a single oral dose of 2.5 mg of anagrelide
203545|NCT01552928|O2|Outcome|BCH24426 (Females)|Metabolite from a single oral dose of 0.5 mg of anagrelide
203546|NCT01552928|O1|Outcome|BCH24426 (Males)|Metabolite from a single oral dose of 0.5 mg of anagrelide
203547|NCT01552928|O2|Outcome|Anagrelide 2.5mg (Females)|A single oral dose of 2.5 mg of anagrelide
203548|NCT01552928|O1|Outcome|Anagrelide 2.5mg (Males)|A single oral dose of 2.5 mg of anagrelide
203549|NCT01552928|O2|Outcome|Anagrelide 0.5 mg (Females)|A single oral dose of 0.5 mg of anagrelide
203550|NCT01552928|O1|Outcome|Anagrelide 0.5 mg (Males)|A single oral dose of 0.5 mg of anagrelide
203551|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
203552|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
203553|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
203554|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
203555|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
203556|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
203557|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
203562|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
203563|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
203564|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
203565|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
203566|NCT01552928|E4|Reported Event|Placebo|
203567|NCT01552928|E3|Reported Event|Moxifloxacin 400mg|
203568|NCT01552928|E2|Reported Event|Anagrelide 2.5mg|
203569|NCT01552928|E1|Reported Event|Anagrelide 0.5mg|
203570|NCT01552915|B4|Baseline|Total|Total of all reporting groups
203571|NCT01552915|B3|Baseline|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
203572|NCT01552915|B2|Baseline|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
203573|NCT01552915|B1|Baseline|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
203574|NCT01552915|P3|Participant Flow|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
203575|NCT01552915|P2|Participant Flow|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day
203576|NCT01552915|P1|Participant Flow|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
203577|NCT01552915|O3|Outcome|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
203578|NCT01552915|O2|Outcome|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
203579|NCT01552915|O1|Outcome|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
203580|NCT01552915|O3|Outcome|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
203581|NCT01552915|O2|Outcome|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
203582|NCT01552915|O1|Outcome|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
203583|NCT01552915|O3|Outcome|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
203584|NCT01552915|O2|Outcome|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
203585|NCT01552915|O1|Outcome|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
203586|NCT01552915|O3|Outcome|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
203587|NCT01552915|O2|Outcome|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
203588|NCT01552915|O1|Outcome|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
203589|NCT01552915|O3|Outcome|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
203590|NCT01552915|O2|Outcome|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
203591|NCT01552915|O1|Outcome|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
203592|NCT01552915|E3|Reported Event|OROS-MPH|Subjects received over encapsulated OROS-MPH optimized among a 18, 36, 54 or 72mg dose. Subjects optimized to 72mg received two 36mg tablets.
203593|NCT01552915|E2|Reported Event|SPD489|Subjects received over encapsulated SPD489 optimized among a 30, 50, or 70mg dose.
203594|NCT01552915|E1|Reported Event|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
203595|NCT01552902|B4|Baseline|Total|Total of all reporting groups
203596|NCT01552902|B3|Baseline|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
203597|NCT01552902|B2|Baseline|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
203598|NCT01552902|B1|Baseline|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
203599|NCT01552902|P3|Participant Flow|Methylphenidate|Methylphenidate (Concerta, Osmotic controlled oral release delivery system-methylphenidate [OROS-MPH]) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
203600|NCT01552902|P2|Participant Flow|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 milligram (mg) over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
203601|NCT01552902|P1|Participant Flow|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
203602|NCT01552902|O3|Outcome|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
204763|NCT01546636|O1|Outcome|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
203603|NCT01552902|O2|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
203604|NCT01552902|O1|Outcome|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
203605|NCT01552902|O3|Outcome|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
203606|NCT01552902|O2|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
203607|NCT01552902|O1|Outcome|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
203608|NCT01552902|O3|Outcome|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
203609|NCT01552902|O2|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
203610|NCT01552902|O1|Outcome|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
203611|NCT01552902|O3|Outcome|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
203612|NCT01552902|O2|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
203613|NCT01552902|O1|Outcome|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
203614|NCT01552902|O3|Outcome|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
203615|NCT01552902|O2|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
203616|NCT01552902|O1|Outcome|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
203617|NCT01552902|E3|Reported Event|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
203618|NCT01552902|E2|Reported Event|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
203619|NCT01552902|E1|Reported Event|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
203620|NCT01552889|B3|Baseline|Total|Total of all reporting groups
203621|NCT01552889|B2|Baseline|Collaborative Care (CC)|"Patients randomized to the Collaborate Care (CC) arm of this study will receive brief screening, consultative, and referral services. This collaborative approach includes the patient, the patient's PCP, the cardiologist, and the nurse case manager (NCM), using evidence based recommendations for depression treatment and follow-up care.~Collaborative Care: No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period."
203622|NCT01552889|B1|Baseline|Usual Care (UC)|Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.
203623|NCT01552889|P2|Participant Flow|Collaborative Care (CC)|"Patients randomized to the Collaborate Care (CC) arm of this study will receive brief screening, consultative, and referral services. This collaborative approach includes the patient, the patient's PCP, the cardiologist, and the nurse case manager (NCM), using evidence based recommendations for depression treatment and follow-up care.~Collaborative Care: No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period."
203624|NCT01552889|P1|Participant Flow|Usual Care (UC)|Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.
203625|NCT01552889|O2|Outcome|Collaborative Care|Same as above
203626|NCT01552889|O1|Outcome|Usual Care|Same as above
203627|NCT01552889|O2|Outcome|Collaborative Care|Same as above
203628|NCT01552889|O1|Outcome|Usual Care|Same as above
203629|NCT01552889|O2|Outcome|Collaborative Care (CC)|"Patients randomized to the Collaborate Care (CC) arm of this study will receive brief screening, consultative, and referral services. This collaborative approach includes the patient, the patient's PCP, the cardiologist, and the nurse case manager (NCM), using evidence based recommendations for depression treatment and follow-up care.~Collaborative Care: No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period."
203630|NCT01552889|O1|Outcome|Usual Care (UC)|Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.
203631|NCT01552889|E2|Reported Event|Collaborative Care (CC)|"Patients randomized to the Collaborate Care (CC) arm of this study will receive brief screening, consultative, and referral services. This collaborative approach includes the patient, the patient's PCP, the cardiologist, and the nurse case manager (NCM), using evidence based recommendations for depression treatment and follow-up care.~Collaborative Care: No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period."
203632|NCT01552889|E1|Reported Event|Usual Care (UC)|Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.
203633|NCT01552876|B1|Baseline|All Subjects|All subjects who were enrolled at baseline.
203634|NCT01552876|P2|Participant Flow|Nelfilcon A/ Etafilcon A/ Filcon II 3|nelfilcon A worn first, etafilcon A worn second, Filcon II 3 worn third. Only etafilcon A and nelfilcon A were used in phase I of the study per study protocol, with Filcon II 3 being added to the rotation in Phase II (see outcome 5).
203635|NCT01552876|P1|Participant Flow|Etafilcon A/ Nelfilcon A/Filcon II 3|etafilcon A worn first, nelfilcon A worn second, Filcon II 3 worn third. Only etafilcon A and nelfilcon A were used in phase I of the study per study protocol, with Filcon II 3 being added to the rotation in Phase II (see outcome 5).
203636|NCT01552876|O3|Outcome|Filcon II 3|All subjects wore the Filcon II 3 lens after the wearing of the etafilcon and nelfilcon lenses.
203637|NCT01552876|O2|Outcome|Nelfilcon A|Those who wore Nelfilcon A
203638|NCT01552876|O1|Outcome|Etafilcon A|Those who wore etafilcon A.
203639|NCT01552876|O2|Outcome|Nelfilcon A|Those subjects who wore nelfilcon A.
203640|NCT01552876|O1|Outcome|Etafilcon A|Those subjects who wore etafilcon A.
203641|NCT01552876|O2|Outcome|Nelfilcon A.|Those who wore nelfilcon A.
203642|NCT01552876|O1|Outcome|Etafilcon A|Those who wore etafilcon A.
203643|NCT01552876|O2|Outcome|Nelfilcon A|Those who wore nelfilcon A.
203644|NCT01552876|O1|Outcome|Etafilcon A|Those who wore etafilcon A.
203645|NCT01552876|O2|Outcome|Nelfilcon A|Those subjects who wore nelfilcon A.
203646|NCT01552876|O1|Outcome|Etafilcon A|Those subjects who wore etafilcon A.
203647|NCT01552876|E3|Reported Event|Filcon II 3|Those who wore Filcon II 3 during Phase II
203648|NCT01552876|E2|Reported Event|Nelfilcon A|Those subjects who wore nelfilcon A. (Phase I & II)
203649|NCT01552876|E1|Reported Event|Etafilcon A|Those subjects who wore etafilcon A. (Phase I & II)
203650|NCT01552772|B1|Baseline|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
203651|NCT01552772|P1|Participant Flow|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
203652|NCT01552772|O1|Outcome|Total|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
203653|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
203654|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
203655|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
203656|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
204002|NCT01551056|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
203657|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
203658|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
203659|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
203660|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
203661|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
203662|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
203663|NCT01552772|E1|Reported Event|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
203664|NCT01552694|B3|Baseline|Total|Total of all reporting groups
203665|NCT01552694|B2|Baseline|Placebo|"Matching placebo daily for 2 months~Placebo: oral, matching placebo daily for 2 months"
203666|NCT01552694|B1|Baseline|Sitagliptin|"100 mg sitagliptin/day for 2 months~Sitagliptin: Oral, 100 mg/day for 2 months"
203667|NCT01552694|P2|Participant Flow|Placebo|"Matching placebo daily for 2 months~Placebo: oral, matching placebo daily for 2 months"
203668|NCT01552694|P1|Participant Flow|Sitagliptin|"100 mg sitagliptin/day for 2 months~Sitagliptin: Oral, 100 mg/day for 2 months"
203669|NCT01552694|O2|Outcome|Placebo|"Matching placebo daily for 2 months~Placebo: oral, matching placebo daily for 2 months"
203670|NCT01552694|O1|Outcome|Sitagliptin|"100 mg sitagliptin/day for 2 months~Sitagliptin: Oral, 100 mg/day for 2 months"
203671|NCT01552694|O2|Outcome|Placebo|"Matching placebo daily for 2 months~Placebo: oral, matching placebo daily for 2 months"
203672|NCT01552694|O1|Outcome|Sitagliptin|"100 mg sitagliptin/day for 2 months~Sitagliptin: Oral, 100 mg/day for 2 months"
203673|NCT01552694|O2|Outcome|Placebo|"Matching placebo daily for 2 months~Placebo: oral, matching placebo daily for 2 months"
203674|NCT01552694|O1|Outcome|Sitagliptin|"100 mg sitagliptin/day for 2 months~Sitagliptin: Oral, 100 mg/day for 2 months"
203675|NCT01552694|O2|Outcome|Placebo|"Matching placebo daily for 2 months~Placebo: oral, matching placebo daily for 2 months"
203676|NCT01552694|O1|Outcome|Sitagliptin|"100 mg sitagliptin/day for 2 months~Sitagliptin: Oral, 100 mg/day for 2 months"
203677|NCT01552694|O2|Outcome|Placebo|"Matching placebo daily for 2 months~Placebo: oral, matching placebo daily for 2 months"
203678|NCT01552694|O1|Outcome|Sitagliptin|"100 mg sitagliptin/day for 2 months~Sitagliptin: Oral, 100 mg/day for 2 months"
203679|NCT01552694|E2|Reported Event|Placebo|"Matching placebo daily for 2 months~Placebo: oral, matching placebo daily for 2 months"
203680|NCT01552694|E1|Reported Event|Sitagliptin|"100 mg sitagliptin/day for 2 months~Sitagliptin: Oral, 100 mg/day for 2 months"
203681|NCT01552681|B3|Baseline|Total|Total of all reporting groups
203682|NCT01552681|B2|Baseline|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
203683|NCT01552681|B1|Baseline|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
203684|NCT01552681|P2|Participant Flow|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
203685|NCT01552681|P1|Participant Flow|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
203686|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
203687|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
203688|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
203689|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
203690|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
203691|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
203692|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
203693|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
203694|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
203695|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
203696|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
203697|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
203698|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
203699|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
203700|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
203701|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
203702|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
203703|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
203704|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
203705|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
203706|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
203707|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
203708|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
203709|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
203710|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
203711|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
203712|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
203713|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
203714|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
203715|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
203716|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
203717|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
203718|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
203719|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
203720|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
203721|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
203722|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
203723|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
203724|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
203725|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
203726|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
203727|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
203728|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
203729|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
203730|NCT01552681|E2|Reported Event|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
203731|NCT01552681|E1|Reported Event|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
203732|NCT01552603|B1|Baseline|Artificial Pancreas Control|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm."
203733|NCT01552603|P1|Participant Flow|Artificial Pancreas Control|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm."
203734|NCT01552603|O1|Outcome|Artificial Pancreas Control|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm."
203735|NCT01552603|O1|Outcome|Artificial Pancreas Control|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm."
203736|NCT01552603|E1|Reported Event|Artificial Pancreas Control|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm."
203737|NCT01552343|B3|Baseline|Total|Total of all reporting groups
203738|NCT01552343|B2|Baseline|Desmopressin|Female participants took 1 desmopressin 25 μg tablet and male participants took 1 tablet 75 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
203739|NCT01552343|B1|Baseline|Placebo|Female and male participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
203740|NCT01552343|P2|Participant Flow|Desmopressin|Female participants took 1 desmopressin 25 μg tablet and male participants took 1 tablet 75 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
203741|NCT01552343|P1|Participant Flow|Placebo|Female and male participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
203742|NCT01552343|O4|Outcome|Male - Desmopressin 75 μg|Male participants took 1 tablet 75 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
203743|NCT01552343|O3|Outcome|Female - Desmopressin 25 μg|Female participants took 1 tablet of 25 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
203744|NCT01552343|O2|Outcome|Male - Placebo|Male participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
203745|NCT01552343|O1|Outcome|Female - Placebo|Female participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
203746|NCT01552343|O4|Outcome|Male - Desmopressin 75 μg|Male participants took 1 tablet 75 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
203747|NCT01552343|O3|Outcome|Female - Desmopressin 25 μg|Female participants took 1 tablet of 25 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
203748|NCT01552343|O2|Outcome|Male - Placebo|Male participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
203749|NCT01552343|O1|Outcome|Female - Placebo|Female participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
203750|NCT01552343|O2|Outcome|Placebo|Participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
203751|NCT01552343|O1|Outcome|Desmopressin|Female participants took 1 tablet of 25 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month. Male participants took 1 tablet of 75 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
203752|NCT01552343|O2|Outcome|>= 3 Voids|Study participants who had >=3 voids average from the screening and baseline diaries.
203753|NCT01552343|O1|Outcome|< 3 Voids|Study participants who had <3 voids average from the screening and baseline diaries.
203754|NCT01552343|O1|Outcome|All Participants|All study participants
203755|NCT01552343|O1|Outcome|All Participants|All study participants
203756|NCT01552343|O2|Outcome|Responders|Participants who experienced a reduction from baseline of >=33% in nocturnal voids at the Month 1
203757|NCT01552343|O1|Outcome|Non-Responders|Participants who experienced a reduction from baseline of <33% in nocturnal voids at the Month 1
203758|NCT01552343|O1|Outcome|All Participants|All study participants
204003|NCT01551056|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
204764|NCT01546636|O2|Outcome|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
203759|NCT01552343|E2|Reported Event|Desmopressin|Female participants took 1 desmopressin 25 μg tablet and male participants took 1 tablet 75 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
203760|NCT01552343|E1|Reported Event|Placebo|Female and male participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
203761|NCT01552057|B3|Baseline|Total|Total of all reporting groups
203762|NCT01552057|B2|Baseline|Placebo|"Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.~During the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily."
203763|NCT01552057|B1|Baseline|Duloxetine 60 mg|"Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).~During the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
203764|NCT01552057|P2|Participant Flow|Placebo|"Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.~During the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily."
203765|NCT01552057|P1|Participant Flow|Duloxetine 60 mg|"Treatment Period: Up to 60-milligram (mg) dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).~During the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
203766|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
203767|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
203768|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
203769|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
203770|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
203771|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
203772|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
203773|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
203774|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
203775|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
203776|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
203777|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
203778|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
203779|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
203780|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
203781|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
203782|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
203783|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
203784|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
203785|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
203786|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
203787|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
203788|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
203789|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
203790|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
203791|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
203792|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
203793|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
203794|NCT01552057|E2|Reported Event|Placebo|"Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.~During the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily."
203795|NCT01552057|E1|Reported Event|Duloxetine 60 mg|"Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).~During the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
203796|NCT01551979|B3|Baseline|Total|Total of all reporting groups
203797|NCT01551979|B2|Baseline|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
203798|NCT01551979|B1|Baseline|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
203799|NCT01551979|P2|Participant Flow|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
203800|NCT01551979|P1|Participant Flow|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
203801|NCT01551979|O2|Outcome|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
203802|NCT01551979|O1|Outcome|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
203803|NCT01551979|O2|Outcome|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
203804|NCT01551979|O1|Outcome|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
203805|NCT01551979|O2|Outcome|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
203806|NCT01551979|O1|Outcome|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
203807|NCT01551979|O2|Outcome|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
203808|NCT01551979|O1|Outcome|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
203809|NCT01551979|O2|Outcome|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
203810|NCT01551979|O1|Outcome|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
203811|NCT01551979|O2|Outcome|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
203812|NCT01551979|O1|Outcome|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
203813|NCT01551979|E2|Reported Event|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
203814|NCT01551979|E1|Reported Event|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
203815|NCT01551888|B1|Baseline|Overall Study Population|All patients participating in the crossover study
203816|NCT01551888|P2|Participant Flow|Sequence 2|Formoterol 12 μg via the Foradil® Aerolizer®, one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day in Period 1 and, in Period 2, Aclidinium/formoterol 400 μg/12 μg FDC (via the Almirall inhaler) one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day
203817|NCT01551888|P1|Participant Flow|Sequence 1|Aclidinium/formoterol 400 μg/12 μg FDC (via the Almirall inhaler) one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day in Period 1 and, in Period 2, Formoterol 12 μg via the Foradil® Aerolizer®, one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day
203818|NCT01551888|O2|Outcome|Aclidinium/Formoterol 400/12 μg FDC|Fixed dose combination (FDC) administered via Almirall inhaler
203819|NCT01551888|O1|Outcome|Formoterol 12 μg|Administered via Foradil® Aerolizer®
203820|NCT01551888|O2|Outcome|Aclidinium/Formoterol 400/12 μg FDC|Fixed dose combination (FDC) administered via Almirall inhaler
203821|NCT01551888|O1|Outcome|Formoterol 12 μg|Administered via Foradil® Aerolizer®
203822|NCT01551888|O2|Outcome|Aclidinium/Formoterol 400/12 μg FDC|Fixed dose combination (FDC) administered via Almirall inhaler
203823|NCT01551888|O1|Outcome|Formoterol 12 μg|Administered via Foradil® Aerolizer®
203824|NCT01551888|O2|Outcome|Aclidinium/Formoterol 400/12 μg FDC|Fixed dose combination (FDC) administered via Almirall inhaler
203825|NCT01551888|O1|Outcome|Formoterol 12 μg|Administered via Foradil® Aerolizer®
203826|NCT01551888|E2|Reported Event|Formoterol 12 μg|Administered via Foradil® Aerolizer®
203827|NCT01551888|E1|Reported Event|Aclidinium/Formoterol 400/12 μg|Fixed dose combination (FDC) administered via Almirall inhaler
203828|NCT01551758|B3|Baseline|Total|Total of all reporting groups
203829|NCT01551758|B2|Baseline|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate/vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
204004|NCT01551056|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
203830|NCT01551758|B1|Baseline|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
203831|NCT01551758|P2|Participant Flow|Fluticasone Furoate (FF)/Vilanterol (VI) 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate /vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
203832|NCT01551758|P1|Participant Flow|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
203833|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate /vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
203834|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
203835|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate /vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
203836|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
203837|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate/vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
203838|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
203839|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
203840|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
203841|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate /vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
203842|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
203843|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate/vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
203844|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
203845|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate/vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
203846|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
203847|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate/vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
203848|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
203849|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
203850|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
203851|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
203852|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
203853|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
203854|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
203855|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
203856|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
203857|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|ExParticipants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
203858|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
203859|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate /vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
203860|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
203861|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
203862|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
203863|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate /vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
203864|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
203865|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|"Existing Maintenance Therapy:~Long acting bronchodilator therapy alone~ICS alone or in combination with a long acting bronchodilator~Triple maintenance therapy"
203866|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
203867|NCT01551758|E2|Reported Event|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
203868|NCT01551758|E1|Reported Event|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
203879|NCT01551693|P2|Participant Flow|STA-9090 Cohort B|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
203869|NCT01551745|B1|Baseline|Vigil™ Vaccine|"Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).~Vigil™ Vaccine: Patients meeting eligibility criteria will receive Autologous Vigil™ vaccine will be supplied by Gradalis,Inc. Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).~Bevacizumab: Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks."
203870|NCT01551745|P1|Participant Flow|Vigil™ Vaccine|"Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).~Vigil™ Vaccine: Patients meeting eligibility criteria will receive Autologous Vigil™ vaccine will be supplied by Gradalis,Inc. Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).~Bevacizumab: Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks."
203871|NCT01551745|O1|Outcome|Vigil™ Vaccine|"Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).~Vigil™ Vaccine: Patients meeting eligibility criteria will receive Autologous Vigil™ vaccine will be supplied by Gradalis,Inc. Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).~Bevacizumab: Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks."
203872|NCT01551745|O1|Outcome|Vigil™ Vaccine|"Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).~Vigil™ Vaccine: Patients meeting eligibility criteria will receive Autologous Vigil™ vaccine will be supplied by Gradalis,Inc. Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).~Bevacizumab: Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks."
203873|NCT01551745|O1|Outcome|Vigil™ Vaccine|"Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).~Vigil™ Vaccine: Patients meeting eligibility criteria will receive Autologous Vigil™ vaccine will be supplied by Gradalis,Inc. Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).~Bevacizumab: Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks."
203874|NCT01551745|O1|Outcome|Vigil™ Vaccine|"Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).~Vigil™ Vaccine: Patients meeting eligibility criteria will receive Autologous Vigil™ vaccine will be supplied by Gradalis,Inc. Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).~Bevacizumab: Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks."
203875|NCT01551745|E1|Reported Event|Vigil™ Vaccine|"Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).~Vigil™ Vaccine: Patients meeting eligibility criteria will receive Autologous Vigil™ vaccine will be supplied by Gradalis,Inc. Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).~Bevacizumab: Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks."
203876|NCT01551693|B3|Baseline|Total|Total of all reporting groups
203877|NCT01551693|B2|Baseline|STA-9090 Cohort B|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
203878|NCT01551693|B1|Baseline|STA-9090 Cohort A|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
203906|NCT01551355|O2|Outcome|Usual Curriculum|education imparted by teachers control preschool facilities continued with their usual preschool curriculum
204765|NCT01546636|O1|Outcome|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
203880|NCT01551693|P1|Participant Flow|STA-9090 Cohort A|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
203881|NCT01551693|O2|Outcome|STA-9090 Cohort B|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
203882|NCT01551693|O1|Outcome|STA-9090 Cohort A|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
203883|NCT01551693|O2|Outcome|STA-9090 Cohort B|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
203884|NCT01551693|O1|Outcome|STA-9090 Cohort A|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
203885|NCT01551693|O2|Outcome|STA-9090 Cohort B|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
203886|NCT01551693|O1|Outcome|STA-9090 Cohort A|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
203887|NCT01551693|E2|Reported Event|STA-9090 Cohort B|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
203888|NCT01551693|E1|Reported Event|STA-9090 Cohort A|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
203889|NCT01551355|B7|Baseline|Total|Total of all reporting groups
203890|NCT01551355|B6|Baseline|Usual Curriculum - Teachers|Control preschool facilities continued with their usual preschool curriculum
203891|NCT01551355|B5|Baseline|Healthy Habits Intervention - Teachers|Teachers participated in 3 centralized training sessions, plus personalized working sessions with a research supervisor (2 hours every 15 days), and received teacher’s guide.
203892|NCT01551355|B4|Baseline|Usual Curriculum - Parents/Caregivers|Control preschool facilities continued with their usual preschool curriculum
203893|NCT01551355|B3|Baseline|Healthy Habits Intervention - Parents/Caregivers|Parents participated in 3 workshops and weekly notes containing positive health messages about nutrition and active lifestyles to share with their children.
203894|NCT01551355|B2|Baseline|Usual Curriculum - Children|Control preschool facilities continued with their usual preschool curriculum
203895|NCT01551355|B1|Baseline|Healthy Habits Intervention - Children|"Preschool Facility* Intervention Arm children provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
203896|NCT01551355|P6|Participant Flow|Usual Curriculum - Teachers|Control preschool facilities continued with their usual preschool curriculum
203897|NCT01551355|P5|Participant Flow|Healthy Habits Intervention - Teachers|Teachers participated in 3 centralized training sessions, plus personalized working sessions with a research supervisor (2 hours every 15 days), and received teacher's guide.
203898|NCT01551355|P4|Participant Flow|Usual Curriculum - Parents/Caregivers|Control preschool facilities continued with their usual preschool curriculum
203899|NCT01551355|P3|Participant Flow|Healthy Habits Intervention - Parents/Caregivers|Parents participated in 3 workshops and weekly notes containing positive health messages about nutrition and active lifestyles to share with their children.
203900|NCT01551355|P2|Participant Flow|Usual Curriculum|children - education imparted by teachers control preschool facilities continued with their usual preschool curriculum
203901|NCT01551355|P1|Participant Flow|Healthy Habits Intervention|"Preschool Facility* Intervention Arm children provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
203902|NCT01551355|O2|Outcome|Usual Curriculum|children - education imparted by teachers control preschool facilities continued with their usual preschool curriculum
203903|NCT01551355|O1|Outcome|Healthy Habits Intervention|"Preschool Facility* Intervention Arm children provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
203904|NCT01551355|O2|Outcome|Usual Curriculum|education imparted by teachers control preschool facilities continued with their usual preschool curriculum
203905|NCT01551355|O1|Outcome|Healthy Habits Intervention|"Preschool Facility* Intervention Arm classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
203907|NCT01551355|O1|Outcome|Healthy Habits Intervention|"Preschool Facility* Intervention Arm classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
203908|NCT01551355|O2|Outcome|Usual Curriculum|education imparted by teachers control preschool facilities continued with their usual preschool curriculum
203909|NCT01551355|O1|Outcome|Healthy Habits Intervention|"Preschool Facility* Intervention Arm classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
203910|NCT01551355|E2|Reported Event|Usual Curriculum|children - education imparted by teachers control preschool facilities continued with their usual preschool curriculum
203911|NCT01551355|E1|Reported Event|Healthy Habits Intervention|"Preschool Facility* Intervention Arm children provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
203912|NCT01551303|B3|Baseline|Total|Total of all reporting groups
203913|NCT01551303|B2|Baseline|Placebo|Placebo, 0.77 ml, intranasal
203914|NCT01551303|B1|Baseline|Oxytocin|Oxytocin, 30 IU in 0.77 ml, intranasal
203915|NCT01551303|P2|Participant Flow|Placebo|Placebo, 0.77 ml, intranasal
203916|NCT01551303|P1|Participant Flow|Oxytocin|Oxytocin, 30 IU in 0.77 ml, intranasal
203917|NCT01551303|O2|Outcome|Placebo|Placebo, 0.77 ml, intranasal
203918|NCT01551303|O1|Outcome|Oxytocin|Oxytocin, 30 IU in 0.77 ml, intranasal
203919|NCT01551303|E2|Reported Event|Oxytocin|"Liquid intranasal oxytocin administered in a nasal spray.~Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once."
203920|NCT01551303|E1|Reported Event|Placebo|"Matched nasal spray placebo.~Placebo: Matched nasal spray placebo"
203921|NCT01551199|B1|Baseline|Multiple Channel Exposure Therapy (MCET)|"MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks~Multiple Channel Exposure Therapy- Veterans: Individual therapy design completed twice a week over a 6-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises."
203922|NCT01551199|P1|Participant Flow|Multiple Channel Exosure Therapy (MCET-V)|"MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks~Multiple Channel Exposure Therapy- Veterans: Individual therapy design completed twice a week over a 6-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises."
203923|NCT01551199|O1|Outcome|MCET-V|MCET-V is a 12-session intervention targeting panic and PTSD symptoms.
203924|NCT01551199|O1|Outcome|MCET-V|MCET-V is a 12-session intervention targeting panic and PTSD symptoms.
203925|NCT01551199|O1|Outcome|MCET-V|MCET-V is a 12-session intervention targeting panic and PTSD symptoms.
203926|NCT01551199|E1|Reported Event|Arm 1|"MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks~Multiple Channel Exposure Therapy- Veterans: Individual therapy design completed twice a week over a 6-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises."
203927|NCT01551173|B3|Baseline|Total|Total of all reporting groups
203928|NCT01551173|B2|Baseline|Fluvastatin Sodium Immediate Release Capsule|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
203929|NCT01551173|B1|Baseline|Fluvastatin Sodium Extended Release Tablet|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
203930|NCT01551173|P2|Participant Flow|Fluvastatin Sodium Immediate Release Capsule|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
203931|NCT01551173|P1|Participant Flow|Fluvastatin Sodium Extended Release Tablet|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
203932|NCT01551173|O2|Outcome|Fluvastatin Sodium Immediate Release Capsule|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
203933|NCT01551173|O1|Outcome|Fluvastatin Sodium Extended Release Tablet|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
203934|NCT01551173|O2|Outcome|Fluvastatin Sodium Immediate Release Capsule|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
203935|NCT01551173|O1|Outcome|Fluvastatin Sodium Extended Release Tablet|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
203936|NCT01551173|O2|Outcome|Fluvastatin Sodium Immediate Release Capsule|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
203937|NCT01551173|O1|Outcome|Fluvastatin Sodium Extended Release Tablet|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
203938|NCT01551173|E3|Reported Event|Total|
203939|NCT01551173|E2|Reported Event|LescolIR (Fluvastatin Sodium Immediate Release Capsule)|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
203940|NCT01551173|E1|Reported Event|LescolXL (Fluvastatin Sodium Extended Release Tablet)|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
203941|NCT01551095|B1|Baseline|PEGJ|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEGJ tube: The self-propelled PEGJ feeding tube"
203942|NCT01551095|P1|Participant Flow|PEGJ|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEGJ tube: The self-propelled PEGJ feeding tube"
203943|NCT01551095|O1|Outcome|PEGJ|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEGJ tube: The self-propelled PEGJ feeding tube"
203944|NCT01551095|O1|Outcome|PEGJ|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEGJ tube: The self-propelled PEGJ feeding tube"
203945|NCT01551095|E1|Reported Event|PEGJ|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEGJ tube: The self-propelled PEGJ feeding tube"
203946|NCT01551082|B1|Baseline|Outpatient Chest Tubes|All patients, mixed gender, race, and age, who underwent thoracic resection by one surgeon over the past seven years and discharged home with air leak present and chest tube to portable drainage device.
204000|NCT01551056|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
204001|NCT01551056|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
203947|NCT01551082|P1|Participant Flow|Outpatient Chest Tubes|All patients, mixed gender, race, and age, who underwent thoracic resection by one surgeon over the past seven years and discharged home with air leak present and chest tube to portable drainage device.
203948|NCT01551082|O1|Outcome|Outpatient Chest Tubes|All patients, mixed gender, race, and age, who underwent thoracic resection by one surgeon over the past seven years and discharged home with air leak present and chest tube to portable drainage device.
203949|NCT01551082|E1|Reported Event|Outpatient Chest Tubes|All patients, mixed gender, race, and age, who underwent thoracic resection by one surgeon over the past seven years and discharged home with air leak present and chest tube to portable drainage device.
203950|NCT01551056|B3|Baseline|Total|Total of all reporting groups
203951|NCT01551056|B2|Baseline|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
203952|NCT01551056|B1|Baseline|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
203953|NCT01551056|P2|Participant Flow|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
203954|NCT01551056|P1|Participant Flow|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
203955|NCT01551056|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
203956|NCT01551056|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
203957|NCT01551056|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
203958|NCT01551056|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
203959|NCT01551056|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
203960|NCT01551056|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
203961|NCT01551056|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
203962|NCT01551056|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
203963|NCT01551056|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
203964|NCT01551056|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
203965|NCT01551056|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
203966|NCT01551056|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
203967|NCT01551056|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
203968|NCT01551056|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
203969|NCT01551056|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
203970|NCT01551056|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
203971|NCT01551056|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
203972|NCT01551056|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
203973|NCT01551056|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
203974|NCT01551056|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
203975|NCT01551056|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
203976|NCT01551056|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
203977|NCT01551056|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
203978|NCT01551056|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
203979|NCT01551056|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
203980|NCT01551056|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
203981|NCT01551056|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
203982|NCT01551056|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
203983|NCT01551056|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
203984|NCT01551056|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
203985|NCT01551056|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
203986|NCT01551056|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
203987|NCT01551056|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
203988|NCT01551056|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
203989|NCT01551056|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
203990|NCT01551056|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
203991|NCT01551056|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
203992|NCT01551056|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
203993|NCT01551056|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
203994|NCT01551056|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
203995|NCT01551056|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
203996|NCT01551056|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
203997|NCT01551056|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
203998|NCT01551056|O1|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
203999|NCT01551056|O2|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
204005|NCT01551056|E2|Reported Event|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
204006|NCT01551056|E1|Reported Event|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
204007|NCT01550965|B1|Baseline|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
204008|NCT01550965|P1|Participant Flow|Participants Receiving Adalimumab|Adults with active ulcerative colitis (UC) who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
204009|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
204010|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
204011|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
204012|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|"Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.~Adalimumab: Adalimumab pre-filled syringe, administered by subcutaneous injection"
204013|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
204014|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
204015|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
204016|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
204017|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
204018|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
204019|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
204020|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
204021|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
204022|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
204023|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
204049|NCT01550757|B3|Baseline|Arm 3: Normal Homeless Oriented PACT Clinical Care|Normal Homeless Oriented Patient Aligned Care Team Clinical Care
204024|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
204025|NCT01550965|E1|Reported Event|PARTICIPANTS RECEIVING ADALIMUMAB|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
204026|NCT01550952|B1|Baseline|Total Shoulder Arthroplasty Patients|
204027|NCT01550952|P1|Participant Flow|Total Shoulder Arthroplasty Patients|
204028|NCT01550952|O1|Outcome|Total Shoulder Arthroplasty Patients|
204029|NCT01550952|O1|Outcome|Total Shoulder Arthroplasty Patients|
204030|NCT01550952|O1|Outcome|Total Shoulder Arthroplasty Patients|
204031|NCT01550952|O1|Outcome|Total Shoulder Arthroplasty Patients|
204032|NCT01550952|O1|Outcome|Total Shoulder Arthroplasty Patients|
204033|NCT01550952|E1|Reported Event|Total Shoulder Arthroplasty Patients|
204034|NCT01550809|B3|Baseline|Total|Total of all reporting groups
204035|NCT01550809|B2|Baseline|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
204036|NCT01550809|B1|Baseline|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
204037|NCT01550809|P2|Participant Flow|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
204038|NCT01550809|P1|Participant Flow|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
204039|NCT01550809|O2|Outcome|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
204040|NCT01550809|O1|Outcome|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
204041|NCT01550809|O2|Outcome|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
204042|NCT01550809|O1|Outcome|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
204043|NCT01550809|O2|Outcome|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
204044|NCT01550809|O1|Outcome|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
204045|NCT01550809|E2|Reported Event|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
204046|NCT01550809|E1|Reported Event|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
204047|NCT01550757|B5|Baseline|Total|Total of all reporting groups
204048|NCT01550757|B4|Baseline|Arm 4: Normal Homeless Oriented PACT Clinical Care + Embedded|"Normal Homeless Oriented PACT Clinical Care + Embedded Peer Mentor~Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research."
204050|NCT01550757|B2|Baseline|Arm 2: Normal PACT Clinical Care + Embedded Peer Mentor|"Normal PACT Clinical Care + Embedded Peer Mentor~Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research."
204051|NCT01550757|B1|Baseline|Arm 1: Normal PACT Clinical Care|Normal Patient Aligned Care Team Clinical Care
204052|NCT01550757|P4|Participant Flow|Arm 4: Normal Homeless Oriented PACT Clinical Care + Embedded|"Normal Homeless Oriented PACT Clinical Care + Embedded Peer Mentor~Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research."
204053|NCT01550757|P3|Participant Flow|Arm 3: Normal Homeless Oriented PACT Clinical Care|Normal Homeless Oriented Patient Aligned Care Team Clinical Care
204054|NCT01550757|P2|Participant Flow|Arm 2: Normal PACT Clinical Care + Embedded Peer Mentor|"Normal PACT Clinical Care + Embedded Peer Mentor~Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research."
204055|NCT01550757|P1|Participant Flow|Arm 1: Normal PACT Clinical Care|Normal Patient Aligned Care Team Clinical Care
204056|NCT01550757|O4|Outcome|Arm 4: Normal Homeless Oriented PACT Clinical Care + Embedded|"Normal Homeless Oriented PACT Clinical Care + Embedded Peer Mentor~Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research."
204057|NCT01550757|O3|Outcome|Arm 3: Normal Homeless Oriented PACT Clinical Care|Normal Homeless Oriented Patient Aligned Care Team Clinical Care
204058|NCT01550757|O2|Outcome|Arm 2: Normal PACT Clinical Care + Embedded Peer Mentor|"Normal PACT Clinical Care + Embedded Peer Mentor~Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research."
204059|NCT01550757|O1|Outcome|Arm 1: Normal PACT Clinical Care|Normal Patient Aligned Care Team Clinical Care
204060|NCT01550757|E4|Reported Event|Arm 4: Normal Homeless Oriented PACT Clinical Care + Embedded|"Normal Homeless Oriented PACT Clinical Care + Embedded Peer Mentor~Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research."
204061|NCT01550757|E3|Reported Event|Arm 3: Normal Homeless Oriented PACT Clinical Care|Normal Homeless Oriented Patient Aligned Care Team Clinical Care
204062|NCT01550757|E2|Reported Event|Arm 2: Normal PACT Clinical Care + Embedded Peer Mentor|"Normal PACT Clinical Care + Embedded Peer Mentor~Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research."
204063|NCT01550757|E1|Reported Event|Arm 1: Normal PACT Clinical Care|Normal Patient Aligned Care Team Clinical Care
204064|NCT01550744|B1|Baseline|Ustekinumab 45 mg/Ustekinumab 90 mg|Open-label period (Week 0-28) - ustekinumab subcutaneous (SC) injections of 45 milligram (mg) at Week 0, 4 and 16 for participants with weight less than or equal to (<=) 100 kilograms (kg) at Week 0 or 90 mg at Week 0, 4, and 16 for participants with weight greater than (>) 100 kg at Week 0.
204065|NCT01550744|P3|Participant Flow|Group 2: Subject-tailored Fixed-interval Maintenance Regimen|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed <= 100 kg received 1 ustekinumab SC of 45 mg or placebo and participants who weighed > 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
204066|NCT01550744|P2|Participant Flow|Group 1: Approved q12w Maintenance Regimen|Randomized double-blind period (Week 28-124) - Participants who weighed <= 100 kg received 1 ustekinumab SC injection of 45 mg or placebo and participants who weighed > 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
204067|NCT01550744|P1|Participant Flow|Ustekinumab 45 mg/Ustekinumab 90 mg|Open-label period (Week 0-28) - ustekinumab subcutaneous (SC) injections of 45 milligram (mg) at Week 0, 4 and 16 for participants with weight less than or equal to (<=) 100 kilograms (kg) at Week 0 or 90 mg at Week 0, 4, and 16 for participants with weight greater than (>) 100 kg at Week 0.
204766|NCT01546636|O2|Outcome|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
204068|NCT01550744|O2|Outcome|Group 2: Ustekinumab Subject-tailored Fixed-interval MR|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection (sc) of 45 mg or placebo and participants who weighed > 100 kg received 2 sc injections of ustekinumab 45 mg or placebo.
204069|NCT01550744|O1|Outcome|Group 1: Ustekinumab q12w Maintenance Regimen (MR)|Randomized double-blind period (Week 28-124) - Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection of 45 milligram (mg) or placebo and participants who weighed > 100 kg received 2 subcutaneous injections of ustekinumab 45 mg or placebo.
204070|NCT01550744|O2|Outcome|Group 2: Ustekinumab Subject-tailored Fixed-interval MR|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection (sc) of 45 mg or placebo and participants who weighed > 100 kg received 2 sc injections of ustekinumab 45 mg or placebo.
204071|NCT01550744|O1|Outcome|Group 1: Ustekinumab q12w Maintenance Regimen (MR)|Randomized double-blind period (Week 28-124) - Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection of 45 milligram (mg) or placebo and participants who weighed > 100 kg received 2 subcutaneous injections of ustekinumab 45 mg or placebo.
204072|NCT01550744|O2|Outcome|Group 2: Ustekinumab Subject-tailored Fixed-interval MR|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection (sc) of 45 mg or placebo and participants who weighed > 100 kg received 2 sc injections of ustekinumab 45 mg or placebo.
204073|NCT01550744|O1|Outcome|Group 1: Ustekinumab q12w Maintenance Regimen (MR)|Randomized double-blind period (Week 28-124) - Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection of 45 milligram (mg) or placebo and participants who weighed > 100 kg received 2 subcutaneous injections of ustekinumab 45 mg or placebo.
204074|NCT01550744|O2|Outcome|Group 2: Ustekinumab Subject-tailored Fixed-interval MR|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection (sc) of 45 mg or placebo and participants who weighed > 100 kg received 2 sc injections of ustekinumab 45 mg or placebo.
204075|NCT01550744|O1|Outcome|Group 1: Ustekinumab q12w Maintenance Regimen (MR)|Randomized double-blind period (Week 28-124) - Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection of 45 milligram (mg) or placebo and participants who weighed > 100 kg received 2 subcutaneous injections of ustekinumab 45 mg or placebo.
204076|NCT01550744|E3|Reported Event|Group 2: Subject-tailored Fixed-interval Maintenance Regimen|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed <= 100 kg received 1 ustekinumab SC of 45 mg or placebo and participants who weighed > 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
204077|NCT01550744|E2|Reported Event|Group 1: Approved q12w Maintenance Regimen|Randomized double-blind period (Week 28-124) - Participants who weighed <= 100 kg received 1 ustekinumab SC injection of 45 mg or placebo and participants who weighed > 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
204078|NCT01550744|E1|Reported Event|Ustekinumab 45 mg/Ustekinumab 90 mg|Open-label period (Week 0-28) - ustekinumab subcutaneous (SC) injections of 45 milligram (mg) at Week 0, 4 and 16 for participants with weight less than or equal to (<=) 100 kilograms (kg) at Week 0 or 90 mg at Week 0, 4, and 16 for participants with weight greater than (>) 100 kg at Week 0.
204079|NCT01550705|B1|Baseline|Isoniazid|"Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.~Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months."
204080|NCT01550705|P1|Participant Flow|Isoniazid|"Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.~Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months."
204081|NCT01550705|O1|Outcome|Isoniazid|"Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.~Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months."
204082|NCT01550705|O1|Outcome|Isoniazid|"Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.~Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months."
204083|NCT01550705|E1|Reported Event|Isoniazid|"Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.~Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months."
204084|NCT01550549|B1|Baseline|Florbetapir-PET Scans|All subjects with a valid florbetapir-PET scan (59 from study A07/A16 and 92 from study A05)
204085|NCT01550549|P1|Participant Flow|Florbetapir-PET Scans|All subject scans with a valid florbetapir-PET scan
204086|NCT01550549|O1|Outcome|Autopsy Within One Year of Scan|Group of subjects with valid images who came to autopsy within 1 year of scan
204087|NCT01550549|O1|Outcome|All Autopsy Population|Group of subjects with valid images who came to autopsy within 2 year of scan
204088|NCT01550549|O1|Outcome|All Autopsy Population|
204089|NCT01550549|O1|Outcome|All Florbetapir-PET Scans|All subjects with a valid florbetapir-PET scan
204090|NCT01550549|O2|Outcome|Autopsy Within One Year of Scan|Subjects with a valid florbetapir-PET scan and autopsy (only those who deceased less than 12 months after the scan)
204091|NCT01550549|O1|Outcome|All Autopsy|Subjects with a valid florbetapir-PET scan and autopsy (including those who deceased more than 12 months after the scan)
204092|NCT01550549|O2|Outcome|Autopsy Within One Year of Scan|Subjects with a valid florbetapir-PET scan and autopsy (only those who deceased less than 12 months after the scan)
204093|NCT01550549|O1|Outcome|All Autopsy|Subjects with a valid florbetapir-PET scan and autopsy (including those who deceased more than 12 months after the scan)
204094|NCT01550549|O1|Outcome|Florbetapir-PET Scans Primary Analysis Group|
204095|NCT01550549|E1|Reported Event|Florbetapir-PET Scans|All subject scans with a valid florbetapir-PET scan
204096|NCT01550302|B3|Baseline|Total|Total of all reporting groups
204097|NCT01550302|B2|Baseline|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.~Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.~Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
204098|NCT01550302|B1|Baseline|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
204099|NCT01550302|P2|Participant Flow|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.~Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.~Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
204100|NCT01550302|P1|Participant Flow|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
204101|NCT01550302|O2|Outcome|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.~Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.~Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
204102|NCT01550302|O1|Outcome|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
204103|NCT01550302|O2|Outcome|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.~Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.~Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
204104|NCT01550302|O1|Outcome|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
204161|NCT01549977|O2|Outcome|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
204162|NCT01549977|O1|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
204163|NCT01549977|O2|Outcome|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
204105|NCT01550302|O2|Outcome|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.~Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.~Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
204106|NCT01550302|O1|Outcome|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
204107|NCT01550302|O2|Outcome|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.~Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.~Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
204108|NCT01550302|O1|Outcome|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
204109|NCT01550302|O2|Outcome|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.~Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.~Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
204110|NCT01550302|O1|Outcome|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
204111|NCT01550302|O2|Outcome|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.~Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.~Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
204112|NCT01550302|O1|Outcome|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
204113|NCT01550302|O2|Outcome|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.~Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.~Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
204114|NCT01550302|O1|Outcome|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
204164|NCT01549977|O1|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
204165|NCT01549977|E2|Reported Event|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
204166|NCT01549977|E1|Reported Event|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
204167|NCT01549964|B5|Baseline|Total|Total of all reporting groups
204115|NCT01550302|E2|Reported Event|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.~Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.~Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
204116|NCT01550302|E1|Reported Event|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
204117|NCT01550289|B3|Baseline|Total|Total of all reporting groups
204118|NCT01550289|B2|Baseline|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
204119|NCT01550289|B1|Baseline|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
204120|NCT01550289|P2|Participant Flow|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
204121|NCT01550289|P1|Participant Flow|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
204122|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants who received 3 vaccinations of placebo vaccine.
204123|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants who received 3 vaccinations of the CYD Dengue Vaccine.
204124|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
204125|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
204126|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants who received 3 vaccinations of placebo vaccine.
204127|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants who received 3 vaccinations of the CYD Dengue Vaccine.
204128|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants who received 3 vaccinations of placebo vaccine.
204129|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants who received 3 vaccinations of the CYD Dengue Vaccine.
204130|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
204131|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
204132|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
204133|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
204134|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
204135|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
204136|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
204137|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
204138|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
204139|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
204140|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
204141|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
204142|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
204143|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
204144|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
204145|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
204146|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
204147|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
204148|NCT01550289|E2|Reported Event|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
204149|NCT01550289|E1|Reported Event|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
204150|NCT01549977|B3|Baseline|Total|Total of all reporting groups
204151|NCT01549977|B2|Baseline|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
204152|NCT01549977|B1|Baseline|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
204153|NCT01549977|P2|Participant Flow|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
204154|NCT01549977|P1|Participant Flow|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
204155|NCT01549977|O2|Outcome|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
204156|NCT01549977|O1|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
204157|NCT01549977|O2|Outcome|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
204158|NCT01549977|O1|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
204159|NCT01549977|O2|Outcome|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
204160|NCT01549977|O1|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
204168|NCT01549964|B4|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
204169|NCT01549964|B3|Baseline|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
204170|NCT01549964|B2|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
204171|NCT01549964|B1|Baseline|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
204172|NCT01549964|P4|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
204173|NCT01549964|P3|Participant Flow|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
204174|NCT01549964|P2|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
204175|NCT01549964|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
204176|NCT01549964|O4|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
204177|NCT01549964|O3|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
204178|NCT01549964|O2|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
204179|NCT01549964|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
204180|NCT01549964|O4|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
204181|NCT01549964|O3|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
204182|NCT01549964|O2|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
204183|NCT01549964|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
204767|NCT01546636|O1|Outcome|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
204184|NCT01549964|O4|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
204185|NCT01549964|O3|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
204186|NCT01549964|O2|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
204187|NCT01549964|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
204188|NCT01549964|E4|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
204189|NCT01549964|E3|Reported Event|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
204190|NCT01549964|E2|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
204191|NCT01549964|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
204192|NCT01549951|B1|Baseline|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
204193|NCT01549951|P1|Participant Flow|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
204194|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
204195|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
204196|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
204197|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
204198|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
204199|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
204200|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
204201|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
204202|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
204203|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
204204|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
204205|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
204206|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
204207|NCT01549951|E1|Reported Event|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
204208|NCT01549925|B3|Baseline|Total|Total of all reporting groups
204209|NCT01549925|B2|Baseline|LIGASURE|"Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon~LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon"
204210|NCT01549925|B1|Baseline|Standard Surgical Resection|"standard surgical resection using clamps and surgical ligatures~Standard Surgical resection: standard surgical resection using clamps and surgical ligatures"
204211|NCT01549925|P2|Participant Flow|LIGASURE|"Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon~LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon"
204212|NCT01549925|P1|Participant Flow|Standard Surgical Resection|"standard surgical resection using clamps and surgical ligatures~Standard Surgical resection: standard surgical resection using clamps and surgical ligatures"
204213|NCT01549925|O2|Outcome|LIGASURE|"Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon~LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon"
204214|NCT01549925|O1|Outcome|Standard Surgical Resection|"standard surgical resection using clamps and surgical ligatures~Standard Surgical resection: standard surgical resection using clamps and surgical ligatures"
204215|NCT01549925|E2|Reported Event|LIGASURE|"Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon~LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon"
204216|NCT01549925|E1|Reported Event|Standard Surgical Resection|"standard surgical resection using clamps and surgical ligatures~Standard Surgical resection: standard surgical resection using clamps and surgical ligatures"
204217|NCT01549873|B3|Baseline|Total|Total of all reporting groups
204218|NCT01549873|B2|Baseline|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
204219|NCT01549873|B1|Baseline|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
204220|NCT01549873|P2|Participant Flow|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
204221|NCT01549873|P1|Participant Flow|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
204222|NCT01549873|O2|Outcome|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
204223|NCT01549873|O1|Outcome|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
204224|NCT01549873|O2|Outcome|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
204225|NCT01549873|O1|Outcome|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
204226|NCT01549873|O2|Outcome|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
204227|NCT01549873|O1|Outcome|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
204228|NCT01549873|E2|Reported Event|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
204229|NCT01549873|E1|Reported Event|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
204230|NCT01549860|B3|Baseline|Total|Total of all reporting groups
204231|NCT01549860|B2|Baseline|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.~MIST Therapy: Non-contact low frequency ultrasound therapy"
204232|NCT01549860|B1|Baseline|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
204233|NCT01549860|P2|Participant Flow|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.~MIST Therapy: Non-contact low frequency ultrasound therapy"
204234|NCT01549860|P1|Participant Flow|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
204235|NCT01549860|O2|Outcome|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.~MIST Therapy: Non-contact low frequency ultrasound therapy"
204236|NCT01549860|O1|Outcome|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
204237|NCT01549860|O2|Outcome|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.~MIST Therapy: Non-contact low frequency ultrasound therapy"
204768|NCT01546636|E2|Reported Event|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
204238|NCT01549860|O1|Outcome|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
204239|NCT01549860|O2|Outcome|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.~MIST Therapy: Non-contact low frequency ultrasound therapy"
204240|NCT01549860|O1|Outcome|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
204241|NCT01549860|E2|Reported Event|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.~MIST Therapy: Non-contact low frequency ultrasound therapy"
204242|NCT01549860|E1|Reported Event|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
204243|NCT01549613|B3|Baseline|Total|Total of all reporting groups
204244|NCT01549613|B2|Baseline|Standard Treatment of Vancomycin|"Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.~Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours."
204245|NCT01549613|B1|Baseline|Standard Treatment With Daptomycin|"Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol~Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol."
204246|NCT01549613|P2|Participant Flow|Standard Treatment of Vancomycin|"Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.~Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours."
204247|NCT01549613|P1|Participant Flow|Standard Treatment With Daptomycin|"Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol~Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol."
204248|NCT01549613|O2|Outcome|Standard Treatment of Vancomycin|"Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.~Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours."
204249|NCT01549613|O1|Outcome|Standard Treatment With Daptomycin|"Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol~Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol."
204250|NCT01549613|E2|Reported Event|Standard Treatment of Vancomycin|"Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.~Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours."
204251|NCT01549613|E1|Reported Event|Standard Treatment With Daptomycin|"Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol~Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol."
204252|NCT01549405|B3|Baseline|Total|Total of all reporting groups
204253|NCT01549405|B2|Baseline|Nerve Block|"Group that performing intercostal block~İntercostal nerve block : Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery."
204254|NCT01549405|B1|Baseline|Control Group|Control group: Group that without intercostal nerve block
204255|NCT01549405|P2|Participant Flow|Nerve Block|"Group that performing intercostal block~İntercostal nerve block : Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery."
204256|NCT01549405|P1|Participant Flow|Control Group|Control group: Group that without intercostal nerve block
204257|NCT01549405|O2|Outcome|Nerve Block|"Group that performing intercostal block~İntercostal nerve block : Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery."
204258|NCT01549405|O1|Outcome|Control Group|Control group: Group that without intercostal nerve block
204259|NCT01549405|O2|Outcome|İntercostal Nerve Block|Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery.
204260|NCT01549405|O1|Outcome|Control|Group that without intercostal nerve block
204261|NCT01549405|E2|Reported Event|İntercostal Nerve Block|Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery.
204262|NCT01549405|E1|Reported Event|Control|Group that without intercostal nerve block
204263|NCT01549392|B3|Baseline|Total|Total of all reporting groups
204264|NCT01549392|B2|Baseline|DECT/MRS in Glioma Patients Not Receiving Avastin|"15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
204265|NCT01549392|B1|Baseline|DECT/MRS in Patients Receiving Avastin|"-15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
204266|NCT01549392|P2|Participant Flow|DECT/MRS in Glioma Patients Not Receiving Avastin|"0 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
204487|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204267|NCT01549392|P1|Participant Flow|DECT/MRS in Patients Receiving Avastin|"3 Glioma Patients underwent DECT and MRS pre-Avastin and 3 months later after receiving avastin 10 mg/kg iv q2weeks~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later Avastin 10 mg/kg iv q2weeks"
204268|NCT01549392|O2|Outcome|DECT/MRS in Glioma Patients Not Receiving Avastin|"15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
204269|NCT01549392|O1|Outcome|DECT/MRS in Patients Receiving Avastin|"-15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
204270|NCT01549392|E2|Reported Event|DECT/MRS in Glioma Patients Not Receiving Avastin|"15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
204271|NCT01549392|E1|Reported Event|DECT/MRS in Patients Receiving Avastin|"-15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
204272|NCT01549340|B1|Baseline|Participants With AR|Participants with AR whose records were retrospectively reviewed
204273|NCT01549340|P1|Participant Flow|Participants With AR|Participants with AR whose records were retrospectively reviewed
204274|NCT01549340|O2|Outcome|Participants With AR Alone|Participants with AR alone who elected AIT and whose records were retrospectively reviewed
204275|NCT01549340|O1|Outcome|Participants With AR and Asthma|Participants with AR and asthma who elected AIT and whose records were retrospectively reviewed
204276|NCT01549340|O1|Outcome|Participants With AR and Asthma|Participants with AR and asthma whose records were retrospectively reviewed
204277|NCT01549340|O2|Outcome|Participants With AR Who Discontinued SLIT|Participants with AR whose records were retrospectively reviewed and discontinued SLIT
204278|NCT01549340|O1|Outcome|Participants With AR Who Discontinued SCIT|Participants with AR whose records were retrospectively reviewed and discontinued SCIT
204279|NCT01549340|O1|Outcome|Participants With AR|Participants with AR whose records were retrospectively reviewed
204280|NCT01549340|O1|Outcome|Participants With AR|Participants with AR whose records were retrospectively reviewed
204281|NCT01549340|O1|Outcome|Participants With AR|Participants with AR whose records were retrospectively reviewed
204282|NCT01549340|E1|Reported Event|Participants With AR|Participants with AR whose records were retrospectively reviewed
204283|NCT01549275|B3|Baseline|Total|Total of all reporting groups
204284|NCT01549275|B2|Baseline|AJCC TNM Staging > = IIIB HCC Patients|Tumor stage is based on the AJCC (American Joint Committee on Cancer) TNM staging system (2010, 7th edition)
204285|NCT01549275|B1|Baseline|AJCC TNM Staging < = IIIA HCC Patients|Tumor stage is based on the AJCC (American Joint Committee on Cancer) TNM staging system (2010, 7th edition)
204286|NCT01549275|P2|Participant Flow|AJCC TNM Staging > = IIIB HCC Patients|29 patients belonged to AJCC TNM staging > = IIIB.
204287|NCT01549275|P1|Participant Flow|AJCC TNM Staging < = IIIA HCC Patients|Tumor stage is based on the AJCC (American Joint Committee on Cancer) TNM staging system (2010, 7th edition). 76 patients with JACC TNM staging < = IIIA.
204288|NCT01549275|O5|Outcome|TNM Staging > = IIIB Patients Receiving Supportive Treatment|All patients belonged to BCLC (Barcelona Clinic Liver Cancer classification) degree C or D.
204289|NCT01549275|O4|Outcome|TNM Staging > = IIIB Patients Receiving TACE|All patients belonged to Child A classification and BCLC (Barcelona Clinic Liver Cancer classification) degree C.
204290|NCT01549275|O3|Outcome|TNM Staging < = IIIA Patients Receiving Supportive Treatment|5 patients belonged to BCLC (Barcelona Clinic Liver Cancer classification) degree B and the other 4 patients belonged to BCLC degree C or D.
204291|NCT01549275|O2|Outcome|TNM Staging < = IIIA Patients Receiving TACE|All patients belonged to Child A classification and BCLC(Barcelona Clinic Liver Cancer classification) degree A or B.
204292|NCT01549275|O1|Outcome|TNM Staging < = IIIA Patients Receiving Curative Treatment|All patient belonged to Child A classification and BCLC (Barcelona Clinic Liver Cancer classification) degree A (14 patients) or B (8 patients).
204293|NCT01549275|O2|Outcome|AJCC TNM Staging < = IIIA HCC Patients|
204294|NCT01549275|O1|Outcome|AJCC TNM Staging > = IIIB|
204295|NCT01549275|E1|Reported Event|HCC Patients Underwent FNA of Tumor|Patients who had residual specimens obtained from ultrasound-guided fine-needle aspiration of hepatic tumor measuring equal or larger than 3cm were included. The residual specimens were applied for primary culture and no additional aspiration of the tumor was performed solely for the collection of specimens for culture. Serious and other Adverse Events were not collected/assessed.
204296|NCT01549223|B3|Baseline|Total|Total of all reporting groups
204297|NCT01549223|B2|Baseline|Protocol Group|"Protocol Group will receive 3 mL syringes marked study solution-oxytocin which contain 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).~If inadequate uterine tone is noted at 9 min, the 1 mL syringe marked marked study solution-9 min, containing methylergonovine maleate (methergine) 0.2mg, will be given IM.~If inadequate uterine tone is noted at 12 min, the 1 mL syringe marked marked study solution-12 min, containing carboprost tromethamine (hemabate) 0.25 mg, will be given IM.~If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.~Oxytocin: 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale)."
204325|NCT01549002|E2|Reported Event|Intravenous Morphine|"Patients in this arm will receive intravenous morphine as their pre-I&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push.~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose"
204488|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204298|NCT01549223|B1|Baseline|Standard Care Group|"Standard Care Group (reflects current clinical regimen at BWH) will receive a 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request. The obstetrician and anesthesiologist will be asked to consider this infusion oxytocin. If inadequate uterine tone exists in which the obstetrician desires alternative uterotonic agents, these will be provided on their request (e.g. methylergonovine maleate (methergine) 0.2 mg IM or carboprost tromethamine (hemabate) 0.25 mg IM. The time of the requests will be recorded.~If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.~Oxytocin: 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request."
204299|NCT01549223|P2|Participant Flow|Protocol Group|"Protocol Group will receive 3 mL syringes marked study solution-oxytocin which contain 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).~If inadequate uterine tone is noted at 9 min, the 1 mL syringe marked marked study solution-9 min, containing methylergonovine maleate (methergine) 0.2mg, will be given IM (Intramuscular).~If inadequate uterine tone is noted at 12 min, the 1 mL syringe marked marked study solution-12 min, containing carboprost tromethamine (hemabate) 0.25 mg, will be given IM.~If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.~Oxytocin: 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale)."
204300|NCT01549223|P1|Participant Flow|Standard Care Group|"Standard Care Group (reflects current clinical regimen at BWH) will receive a 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request. The obstetrician and anesthesiologist will be asked to consider this infusion oxytocin. If inadequate uterine tone exists in which the obstetrician desires alternative uterotonic agents, these will be provided on their request (e.g. methylergonovine maleate (methergine) 0.2 mg IM (Intramuscular) or carboprost tromethamine (hemabate) 0.25 mg IM. The time of the requests will be recorded.~If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.~Oxytocin: 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request."
204301|NCT01549223|O2|Outcome|Protocol Group|"Protocol Group will receive 3 mL syringes marked study solution-oxytocin which contain 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).~If inadequate uterine tone is noted at 9 min, the 1 mL syringe marked marked study solution-9 min, containing methylergonovine maleate (methergine) 0.2mg, will be given IM.~If inadequate uterine tone is noted at 12 min, the 1 mL syringe marked marked study solution-12 min, containing carboprost tromethamine (hemabate) 0.25 mg, will be given IM.~If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.~Oxytocin: 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale)."
204302|NCT01549223|O1|Outcome|Standard Care Group|"Standard Care Group (reflects current clinical regimen at BWH) will receive a 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request. The obstetrician and anesthesiologist will be asked to consider this infusion oxytocin. If inadequate uterine tone exists in which the obstetrician desires alternative uterotonic agents, these will be provided on their request (e.g. methylergonovine maleate (methergine) 0.2 mg IM or carboprost tromethamine (hemabate) 0.25 mg IM. The time of the requests will be recorded.~If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.~Oxytocin: 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request."
204303|NCT01549223|O2|Outcome|Protocol Group|"Protocol Group will receive 3 mL syringes marked study solution-oxytocin which contain 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).~If inadequate uterine tone is noted at 9 min, the 1 mL syringe marked marked study solution-9 min, containing methylergonovine maleate (methergine) 0.2mg, will be given IM.~If inadequate uterine tone is noted at 12 min, the 1 mL syringe marked marked study solution-12 min, containing carboprost tromethamine (hemabate) 0.25 mg, will be given IM.~If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.~Oxytocin: 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale)."
204304|NCT01549223|O1|Outcome|Standard Care Group|"Standard Care Group (reflects current clinical regimen at BWH) will receive a 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request. The obstetrician and anesthesiologist will be asked to consider this infusion oxytocin. If inadequate uterine tone exists in which the obstetrician desires alternative uterotonic agents, these will be provided on their request (e.g. methylergonovine maleate (methergine) 0.2 mg IM or carboprost tromethamine (hemabate) 0.25 mg IM. The time of the requests will be recorded.~If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.~Oxytocin: 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request."
204305|NCT01549223|E2|Reported Event|Protocol Group|"Protocol Group will receive 3 mL syringes marked study solution-oxytocin which contain 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).~If inadequate uterine tone is noted at 9 min, the 1 mL syringe marked marked study solution-9 min, containing methylergonovine maleate (methergine) 0.2mg, will be given IM.~If inadequate uterine tone is noted at 12 min, the 1 mL syringe marked marked study solution-12 min, containing carboprost tromethamine (hemabate) 0.25 mg, will be given IM.~If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.~Oxytocin: 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale)."
204355|NCT01548742|E2|Reported Event|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
204356|NCT01548742|E1|Reported Event|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
205171|NCT01545700|O3|Outcome|Placebo 0-4 Hours-2 Hours|Placebo 0-4 hours-2 hours
204306|NCT01549223|E1|Reported Event|Standard Care Group|"Standard Care Group (reflects current clinical regimen at BWH) will receive a 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request. The obstetrician and anesthesiologist will be asked to consider this infusion oxytocin. If inadequate uterine tone exists in which the obstetrician desires alternative uterotonic agents, these will be provided on their request (e.g. methylergonovine maleate (methergine) 0.2 mg IM or carboprost tromethamine (hemabate) 0.25 mg IM. The time of the requests will be recorded.~If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.~Oxytocin: 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request."
204307|NCT01549041|B3|Baseline|Total|Total of all reporting groups
204308|NCT01549041|B2|Baseline|Asenapine 5 mg Twice Daily|"Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening~Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily"
204309|NCT01549041|B1|Baseline|Asenapine 10 mg Daily in the Evening|"Patients will receive their entire daily dose of asenapine as a single dose in the evening~Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening"
204310|NCT01549041|P2|Participant Flow|Asenapine 5 mg Twice Daily|"Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening~Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily"
204311|NCT01549041|P1|Participant Flow|Asenapine 10 mg Daily in the Evening|"Patients will receive their entire daily dose of asenapine as a single dose in the evening~Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening"
204312|NCT01549041|O2|Outcome|Asenapine 5 mg Twice Daily|"Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening~Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily"
204313|NCT01549041|O1|Outcome|Asenapine 10 mg Daily in the Evening|"Patients will receive their entire daily dose of asenapine as a single dose in the evening~Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening"
204314|NCT01549041|O2|Outcome|Asenapine 5 mg Twice Daily|"Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening~Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily"
204315|NCT01549041|O1|Outcome|Asenapine 10 mg Daily in the Evening|"Patients will receive their entire daily dose of asenapine as a single dose in the evening~Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening"
204316|NCT01549041|E2|Reported Event|Asenapine 5 mg Twice Daily|"Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening~Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily"
204317|NCT01549041|E1|Reported Event|Asenapine 10 mg Daily in the Evening|"Patients will receive their entire daily dose of asenapine as a single dose in the evening~Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening"
204318|NCT01549002|B3|Baseline|Total|Total of all reporting groups
204319|NCT01549002|B2|Baseline|Intravenous Morphine|"Patients in this arm will receive intravenous morphine as their pre-I&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push.~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose"
204320|NCT01549002|B1|Baseline|Intranasal Fentanyl|"Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare).~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose"
204321|NCT01549002|P2|Participant Flow|Intravenous Morphine|"Patients in this arm will receive intravenous morphine as their pre-I&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push.~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose"
204322|NCT01549002|P1|Participant Flow|Intranasal Fentanyl|"Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare).~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose"
204323|NCT01549002|O2|Outcome|Intravenous Morphine|"Patients in this arm will receive intravenous morphine as their pre-I&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push.~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose"
204324|NCT01549002|O1|Outcome|Intranasal Fentanyl|"Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare).~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose"
204483|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204326|NCT01549002|E1|Reported Event|Intranasal Fentanyl|"Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare).~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose"
204327|NCT01548885|B1|Baseline|Study Staff Test BGMSs|All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
204328|NCT01548885|P1|Participant Flow|Study Staff Test BGMSs|All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
204329|NCT01548885|O1|Outcome|Study Staff Test BGMSs|All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
204330|NCT01548885|O1|Outcome|Study Staff Test BGMSs|All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
204331|NCT01548885|E1|Reported Event|Study Staff Test BGMSs|All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
204332|NCT01548833|B1|Baseline|Overall|DT1, TruEye, and Clariti contact lenses worn in randomized, cross-over fashion for one week each
204333|NCT01548833|P1|Participant Flow|Overall|All enrolled participants
204334|NCT01548833|O3|Outcome|Clariti|Filcon II 3 contact lenses worn for one week in a daily wear, daily disposable manner.
204335|NCT01548833|O2|Outcome|TruEye|Narafilcon A contact lenses worn for one week in a daily wear, daily disposable manner.
204336|NCT01548833|O1|Outcome|Dailies Total 1|Delefilcon A contact lenses worn for one week in a daily wear, daily disposable manner.
204337|NCT01548833|E3|Reported Event|Clariti|Filcon II 3 contact lenses worn for one week in a daily wear, daily disposable manner.
204338|NCT01548833|E2|Reported Event|TruEye|Narafilcon A contact lenses worn for one week in a daily wear, daily disposable manner.
204339|NCT01548833|E1|Reported Event|Dailies Total 1|Delefilcon A contact lenses worn for one week in a daily wear, daily disposable manner.
204340|NCT01548742|B3|Baseline|Total|Total of all reporting groups
204341|NCT01548742|B2|Baseline|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
204342|NCT01548742|B1|Baseline|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
204343|NCT01548742|P2|Participant Flow|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
204344|NCT01548742|P1|Participant Flow|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
204345|NCT01548742|O2|Outcome|Arm 2: Present Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
204346|NCT01548742|O1|Outcome|Arm 1: Mindfulness Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
204347|NCT01548742|O2|Outcome|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
204348|NCT01548742|O1|Outcome|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
204349|NCT01548742|O2|Outcome|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
204350|NCT01548742|O1|Outcome|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
204351|NCT01548742|O2|Outcome|Arm 2: Present Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
204352|NCT01548742|O1|Outcome|Arm 1: Mindfulness Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
204353|NCT01548742|O2|Outcome|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
204354|NCT01548742|O1|Outcome|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
204769|NCT01546636|E1|Reported Event|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
204357|NCT01548638|B1|Baseline|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
204358|NCT01548638|P1|Participant Flow|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
204359|NCT01548638|O1|Outcome|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER: The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
204360|NCT01548638|O1|Outcome|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER: The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
204361|NCT01548638|O1|Outcome|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
204362|NCT01548638|O1|Outcome|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER: The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
204363|NCT01548638|O1|Outcome|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
204364|NCT01548638|O1|Outcome|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
204365|NCT01548638|O1|Outcome|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
204366|NCT01548638|E1|Reported Event|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
204367|NCT01548573|B1|Baseline|Tandem Transplant in MM <12 Mos of Prior Treatment|This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
204770|NCT01546623|B3|Baseline|Total|Total of all reporting groups
204368|NCT01548573|P1|Participant Flow|Tandem Transplant in MM <12 Mos of Prior Treatment|This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
204369|NCT01548573|O1|Outcome|Tandem Transplant in MM <12 Mos of Prior Treatment|This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
204370|NCT01548573|O1|Outcome|Tandem Transplant in MM <12 Mos of Prior Treatment|This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
204371|NCT01548573|O1|Outcome|Tandem Transplant in MM <12 Mos of Prior Treatment|This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
204372|NCT01548573|O1|Outcome|Tandem Autologous Stem Cell Transplant|"Induction and PBSC Collection:1 cycle of combination D-PACE (and peripheral blood stem cell collection. After collection, participants may receive interim dexamethasone at 20mg days 1-4 every 14 days.~Transplant 1: 6 weeks after first day of D-PACE , but can occur as early as 4 weeks and as late as 6 months. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.~Transplant 2: 8 weeks-6 months after the first transplant, participants will have second transplant. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.~Consolidation Phase (if administered): 4 weeks-4 months after second transplant, participants may receive consolidation chemotherapy.~Maintenance Phase year 1 and 2:The first year of maintenance will commence between 6 weeks-6 months after consolidation or 4 weeks-6 months after transplant if consolidation is skipped.~DP"
204373|NCT01548573|E1|Reported Event|Tandem Transplant in MM <12 Mos of Prior Treatment|This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
204374|NCT01548417|B3|Baseline|Total|Total of all reporting groups
204375|NCT01548417|B2|Baseline|Placebo|Sugar Pill: placebo, oral pill, 7 days
204376|NCT01548417|B1|Baseline|Korlym (Mifepristone)|Korlym (mifepristone): 600 mg/day, oral pill, 7 days
204377|NCT01548417|P2|Participant Flow|Sugar Pill|Sugar Pill: placebo, oral pill, 7 days
204378|NCT01548417|P1|Participant Flow|Korlym (Mifepristone)|Korlym (mifepristone): 600 mg/day, oral pill, 7 days
204379|NCT01548417|O2|Outcome|Sugar Pill|Sugar Pill: placebo, oral pill, 7 days
204380|NCT01548417|O1|Outcome|Korlym (Mifepristone)|Korlym (mifepristone): 600 mg/day, oral pill, 7 days
204381|NCT01548417|O2|Outcome|Sugar Pill|Sugar Pill: placebo, oral pill, 7 days
204382|NCT01548417|O1|Outcome|Korlym (Mifepristone)|Korlym (mifepristone): 600 mg/day, oral pill, 7 days
204383|NCT01548417|E2|Reported Event|Sugar Pill|Sugar Pill: placebo, oral pill, 7 days
204384|NCT01548417|E1|Reported Event|Korlym (Mifepristone)|Korlym (mifepristone): 600 mg/day, oral pill, 7 days
204385|NCT01548287|B5|Baseline|Total|Total of all reporting groups
204386|NCT01548287|B4|Baseline|Placebo|Placebo daily
204387|NCT01548287|B3|Baseline|AZD5213 Dose C|AZD5213 6.0 mg daily
204388|NCT01548287|B2|Baseline|AZD5213 Dose B|AZD 5213 2.0 mg daily
204389|NCT01548287|B1|Baseline|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
204390|NCT01548287|P5|Participant Flow|Screening Only|Screening period only, not randomized
204391|NCT01548287|P4|Participant Flow|Placebo|Placebo daily
204392|NCT01548287|P3|Participant Flow|AZD5213 Dose C|AZD5213 6.0 mg daily
204393|NCT01548287|P2|Participant Flow|AZD5213 Dose B|AZD 5213 2.0 mg daily
204394|NCT01548287|P1|Participant Flow|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
204395|NCT01548287|O4|Outcome|Placebo|Placebo daily
204396|NCT01548287|O3|Outcome|AZD5213 Dose C|AZD5213 6.0 mg daily
204397|NCT01548287|O2|Outcome|AZD5213 Dose B|AZD 5213 2.0 mg daily
204398|NCT01548287|O1|Outcome|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
204399|NCT01548287|O4|Outcome|Placebo|Placebo daily
204400|NCT01548287|O3|Outcome|AZD5213 Dose C|AZD5213 6.0 mg daily
204401|NCT01548287|O2|Outcome|AZD5213 Dose B|AZD 5213 2.0 mg daily
204402|NCT01548287|O1|Outcome|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
204403|NCT01548287|O4|Outcome|Placebo|Placebo daily
204404|NCT01548287|O3|Outcome|AZD5213 Dose C|AZD5213 6.0 mg daily
204405|NCT01548287|O2|Outcome|AZD5213 Dose B|AZD 5213 2.0 mg daily
204406|NCT01548287|O1|Outcome|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
204407|NCT01548287|O4|Outcome|Placebo|Placebo daily
204408|NCT01548287|O3|Outcome|AZD5213 Dose C|AZD5213 6.0 mg daily
204409|NCT01548287|O2|Outcome|AZD5213 Dose B|AZD 5213 2.0 mg daily
204410|NCT01548287|O1|Outcome|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
204411|NCT01548287|O4|Outcome|Placebo|Placebo daily
204412|NCT01548287|O3|Outcome|AZD5213 Dose C|AZD5213 6.0 mg daily
204413|NCT01548287|O2|Outcome|AZD5213 Dose B|AZD 5213 2.0 mg daily
204414|NCT01548287|O1|Outcome|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
204415|NCT01548287|O4|Outcome|Placebo|Placebo daily
204416|NCT01548287|O3|Outcome|AZD5213 Dose C|AZD5213 6.0 mg daily
204417|NCT01548287|O2|Outcome|AZD5213 Dose B|AZD 5213 2.0 mg daily
204418|NCT01548287|O1|Outcome|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
204419|NCT01548287|E4|Reported Event|Placebo|Placebo daily
204420|NCT01548287|E3|Reported Event|AZD5213 Dose C|AZD5213 6.0 mg daily
204421|NCT01548287|E2|Reported Event|AZD5213 Dose B|AZD 5213 2.0 mg daily
204422|NCT01548287|E1|Reported Event|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
204423|NCT01548040|B3|Baseline|Total|Total of all reporting groups
204484|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204424|NCT01548040|B2|Baseline|Quadriceps TENS|"The sham device will look identical to the Kneehab XP device. All subjects in the control group will receive quadriceps TENS (at a minimal sensory input) using Kneehab XP on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation~quadriceps TENS (at a minimal sensory input) using Kneehab XP: on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively."
204425|NCT01548040|B1|Baseline|Quadriceps NMES Using Kneehab XP|"All subjects in the treatment group will receive quadriceps NMES using Kneehab XP on the affected leg, 20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation~Kneehab XP: NMES using Kneehab XP on the affected leg,20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively"
204426|NCT01548040|P2|Participant Flow|Quadriceps TENS|"The sham device will look identical to the Kneehab XP device. All subjects in the control group will receive quadriceps TENS (at a minimal sensory input) using Kneehab XP on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation~quadriceps TENS (at a minimal sensory input) using Kneehab XP: on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively."
204427|NCT01548040|P1|Participant Flow|Quadriceps NMES Using Kneehab XP|"All subjects in the treatment group will receive quadriceps NMES using Kneehab XP on the affected leg, 20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation~Kneehab XP: NMES using Kneehab XP on the affected leg,20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively"
204428|NCT01548040|O2|Outcome|Quadriceps TENS|"The sham device will look identical to the Kneehab XP device. All subjects in the control group will receive quadriceps TENS (at a minimal sensory input) using Kneehab XP on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation~quadriceps TENS (at a minimal sensory input) using Kneehab XP: on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively."
204429|NCT01548040|O1|Outcome|Quadriceps NMES Using Kneehab XP|"All subjects in the treatment group will receive quadriceps NMES using Kneehab XP on the affected leg, 20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation~Kneehab XP: NMES using Kneehab XP on the affected leg,20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively"
204430|NCT01548040|O2|Outcome|Quadriceps TENS|"The sham device will look identical to the Kneehab XP device. All subjects in the control group will receive quadriceps TENS (at a minimal sensory input) using Kneehab XP on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation~quadriceps TENS (at a minimal sensory input) using Kneehab XP: on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively."
204431|NCT01548040|O1|Outcome|Quadriceps NMES Using Kneehab XP|"All subjects in the treatment group will receive quadriceps NMES using Kneehab XP on the affected leg, 20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation~Kneehab XP: NMES using Kneehab XP on the affected leg,20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively"
204432|NCT01548040|E2|Reported Event|Quadriceps TENS|"The sham device will look identical to the Kneehab XP device. All subjects in the control group will receive quadriceps TENS (at a minimal sensory input) using Kneehab XP on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation~quadriceps TENS (at a minimal sensory input) using Kneehab XP: on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively."
204433|NCT01548040|E1|Reported Event|Quadriceps NMES Using Kneehab XP|"All subjects in the treatment group will receive quadriceps NMES using Kneehab XP on the affected leg, 20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation~Kneehab XP: NMES using Kneehab XP on the affected leg,20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively"
204434|NCT01547806|B1|Baseline|Hematopoietic Progenitor Cells (HPC)|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.~Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days~Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight~Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106^ CD34+ cells/kg."
204485|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204435|NCT01547806|P1|Participant Flow|Hematopoietic Progenitor Cells (HPC)|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.~Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days~Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight~Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 10^6 CD34+ cells/kg."
204436|NCT01547806|O1|Outcome|Hematopoietic Progenitor Cells (HPC)|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.~Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days~Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight~Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 10^6 CD34+ cells/kg."
204437|NCT01547806|O1|Outcome|Hematopoietic Progenitor Cells (HPC)|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.~Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days~Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight~Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 10^6 CD34+ cells/kg."
204438|NCT01547806|O1|Outcome|Hematopoietic Progenitor Cells|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.~Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days~Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight~Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg."
204439|NCT01547806|O1|Outcome|Hematopoietic Progenitor Cells|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.~Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days~Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight~Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg."
204440|NCT01547806|O1|Outcome|Hematopoietic Progenitor Cells|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.~Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days~Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight~Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg."
204441|NCT01547806|O1|Outcome|Hematopoietic Progenitor Cells (HPC)|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.~Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days~Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight~Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 10^6 CD34+ cells/kg."
204442|NCT01547806|O1|Outcome|Hematopoietic Progenitor Cells (HPC)|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.~Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days~Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight~Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 10^6 CD34+ cells/kg."
204443|NCT01547806|O1|Outcome|Hematopoietic Progenitor Cells|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.~Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days~Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight~Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg."
204444|NCT01547806|O1|Outcome|Hematopoietic Progenitor Cells|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.~Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days~Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight~Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg."
204445|NCT01547806|O1|Outcome|Hematopoietic Progenitor Cells|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.~Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days~Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight~Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg."
204446|NCT01547806|O1|Outcome|Hematopoietic Progenitor Cells|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.~Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days~Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight~Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg."
204486|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204447|NCT01547806|O1|Outcome|Hematopoietic Progenitor Cells|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.~Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days~Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight~Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg."
204448|NCT01547806|O1|Outcome|Hematopoietic Progenitor Cells (HPC)|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.~Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days~Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight~Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 10^6 CD34+ cells/kg."
204449|NCT01547806|E1|Reported Event|Hematopoietic Progenitor Cells|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.~Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days~Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight~Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg."
204450|NCT01547728|B1|Baseline|Recombinant Antithrombin (rhAT)|Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.
204451|NCT01547728|P1|Participant Flow|Recombinant Antithrombin (rhAT)|Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.
204452|NCT01547728|O1|Outcome|Recombinant Antithrombin (rhAT)|Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.
204453|NCT01547728|E1|Reported Event|Recombinant Antithrombin (rhAT)|Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.
204454|NCT01547715|B4|Baseline|Total|Total of all reporting groups
204455|NCT01547715|B3|Baseline|19 - 75 Years|Subjects between 19 and 75 years of age received one injection of MenACWY –CRM vaccine on day 1.
204456|NCT01547715|B2|Baseline|11 - 18 Years|Subjects between 11 and 18 years of age received one injection of MenACWY –CRM vaccine on day 1
204457|NCT01547715|B1|Baseline|2 - 10 Years|Subjects between 2 and 10 years of age received one injection of MenACWY –CRM vaccine on day 1
204458|NCT01547715|P3|Participant Flow|19 - 75 Years|Subjects between 19 and 75 years of age received one injection of MenACWY –CRM vaccine on day 1.
204459|NCT01547715|P2|Participant Flow|11 - 18 Years|Subjects between 11 and 18 years of age received one injection of MenACWY –CRM vaccine on day 1.
204460|NCT01547715|P1|Participant Flow|2 - 10 Years|Subjects between 2 and 10 years of age received one injection of MenACWY –CRM vaccine on day 1.
204461|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204462|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204463|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204464|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204465|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204466|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204467|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204468|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204469|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204470|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204471|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204472|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204473|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204474|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204475|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204476|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204477|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204478|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204479|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204480|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204481|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204482|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204489|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204490|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204491|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204492|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204493|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204494|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204495|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204496|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204497|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204498|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204499|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204500|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204501|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204502|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204503|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204504|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204505|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204506|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204507|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204508|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204509|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204510|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204511|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204512|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204513|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204514|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204515|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204516|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204517|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204518|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204519|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204520|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204521|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204522|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204523|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204524|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204525|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204526|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204527|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204528|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204529|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204530|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204531|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204532|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204533|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204534|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
205172|NCT01545700|O2|Outcome|Placebo 0-4 Hours-1 Hour|Placebo 0-4 hours-1 hour
204535|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204536|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204537|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204538|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204539|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204540|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204541|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204542|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204543|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204544|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204545|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204546|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204547|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204548|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204549|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204550|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204551|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204552|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204553|NCT01547715|E4|Reported Event|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204554|NCT01547715|E3|Reported Event|19 - 75 Years|Subjects between 19 and 75 years of age received one injection of MenACWY –CRM vaccine on day 1
204555|NCT01547715|E2|Reported Event|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204556|NCT01547715|E1|Reported Event|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
204557|NCT01547598|B3|Baseline|Total|Total of all reporting groups
204558|NCT01547598|B2|Baseline|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
204559|NCT01547598|B1|Baseline|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
204560|NCT01547598|P2|Participant Flow|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
204561|NCT01547598|P1|Participant Flow|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
204562|NCT01547598|O2|Outcome|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
204563|NCT01547598|O1|Outcome|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
204564|NCT01547598|O2|Outcome|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
204565|NCT01547598|O1|Outcome|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
204566|NCT01547598|O2|Outcome|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
204567|NCT01547598|O1|Outcome|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
204568|NCT01547598|O2|Outcome|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
204692|NCT01546922|P1|Participant Flow|First a Low Dose of HC Followed by a High Dose of HC|First low dose of hydrocortisone = 0.2-0.3 mg/kg body weight for 10 weeks followed by a high dose of hydrocortisone = 0.4-0.6 mg/kg body weight
204569|NCT01547598|O1|Outcome|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
204570|NCT01547598|O2|Outcome|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
204571|NCT01547598|O1|Outcome|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
204572|NCT01547598|E3|Reported Event|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
204573|NCT01547598|E2|Reported Event|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
204574|NCT01547598|E1|Reported Event|Travatan® Z|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks for all participants.
204575|NCT01547390|B3|Baseline|Total|Total of all reporting groups
204576|NCT01547390|B2|Baseline|Aspirin|
204577|NCT01547390|B1|Baseline|Placebo|
204578|NCT01547390|P2|Participant Flow|Aspirin|Study subjects receiving aspirin 81 mg one tablet orally per day.
204579|NCT01547390|P1|Participant Flow|Placebo|Study subjects receiving placebo one tablet orally per day
204580|NCT01547390|O2|Outcome|Aspirin|
204581|NCT01547390|O1|Outcome|Placebo|
204582|NCT01547390|O2|Outcome|Aspirin|
204583|NCT01547390|O1|Outcome|Placebo|
204584|NCT01547390|E2|Reported Event|Aspirin|
204585|NCT01547390|E1|Reported Event|Placebo|
204586|NCT01547299|B3|Baseline|Total|Total of all reporting groups
204587|NCT01547299|B2|Baseline|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204588|NCT01547299|B1|Baseline|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204589|NCT01547299|P2|Participant Flow|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204590|NCT01547299|P1|Participant Flow|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 milligram (mg) of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204591|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204592|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204593|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204594|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204595|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204596|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204597|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204598|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204599|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204600|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204601|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204602|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204603|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204604|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204605|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204606|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204607|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204693|NCT01546922|O2|Outcome|High Dose of Hydrocortisone|Results from the participants while receiving the high dose of hydrocortisone
204608|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204609|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204610|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204611|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204612|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204613|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204614|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204615|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204616|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204617|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204618|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204619|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204620|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204621|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204622|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204623|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204624|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204625|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204626|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204627|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204628|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204629|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204630|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204631|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204632|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204633|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204634|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204635|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204636|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204637|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204638|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204639|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204640|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204641|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
205173|NCT01545700|O1|Outcome|Placebo 0-4 Hours-baseline|Placebo 0-4 hours baseline
204642|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204643|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204644|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204645|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204646|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204647|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204648|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204649|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204650|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204651|NCT01547299|O2|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204652|NCT01547299|O1|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204653|NCT01547299|E2|Reported Event|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
204654|NCT01547299|E1|Reported Event|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
204655|NCT01547286|B1|Baseline|Allergic Asthmatic|Standardized Cat Allergen Extract and Standardized Dust Mite Allergen: The route of administration will be topical application of the titrated allergen via nebulized droplets to the lungs. The starting dose of allergen will be 3 dose dilutions below the estimated PC20-allergen delivered for 5 minutes at tidal breathing, followed by FEV1 at 10-minute intervals until the lowest FEV1 is established. If the %FEV1 fall is < 20%, the next concentration is given, until the FEV1 falls ≥ 20%. When this happens the FEV1 will be followed at 10, 20, 30, 45, and 60 minutes, then hourly for 7 hours. The early asthmatic response is the maximum %FEV1 fall between 0 and 3 hours and the late asthmatic response between 3 and 7 hours post allergen challenge.CT imaging, functional PET imaging: Physiology study using CT and PET imaging with Nitrogen-13 (13NN) saline as radiotracer; images obtained during the early and late phases after allergen challenge. Nebulized methacholine inhalation: Standard
204656|NCT01547286|P1|Participant Flow|Allergic Asthmatic|This is a single physiological group study where each subject served as their own control. All eligible subjects underwent a methacholine challenge test, clinical assessment and skin tests to ascertain the diagnosis of allergic asthma. Both methacholine and skin test results were used to determine the start dose of the bronchial allergen challenge test. CT and PET with Nitrogen-13 (13NN) saline as a radiotracer images were obtained during the early and late phases after allergen challenge.
204657|NCT01547286|O1|Outcome|Allergic Asthmatic|All subjects were allergic asthmatics, each served as their own control. There was no comparator group.
204658|NCT01547286|O1|Outcome|Allergic Asthmatic|All subjects were allergic asthmatics, each served as their own control. There was no comparator group.
204659|NCT01547286|O1|Outcome|Allergic Asthmatic|"Standardized Cat Allergen Extract and Standardized Dust Mite Allergen: The route of administration will be topical application of the titrated allergen via nebulized droplets to the lungs. The starting dose of allergen will be 3 dose dilutions below the estimated PC20-allergen delivered for 5 minutes at tidal breathing, followed by FEV1 at 10-minute intervals until the lowest FEV1 is established. If the %FEV1 fall is < 20%, the next concentration is given, until the FEV1 falls ≥ 20%. When this happens the FEV1 will be followed at 10, 20, 30, 45, and 60 minutes, then hourly for 7 hours. The early asthmatic response is the maximum %FEV1 fall between 0 and 3 hours and the late asthmatic response between 3 and 7 hours post allergen challenge.~CT imaging, functional PET imaging: Physiology study using CT and PET imaging with Nitrogen-13 (13NN) saline as radiotracer; images obtained during the early and late phases after allergen challenge Nebulized methacholine inhalation: Standard"
204660|NCT01547286|O1|Outcome|Allergic Asthmatic|"Standardized Cat Allergen Extract and Standardized Dust Mite Allergen: The route of administration will be topical application of the titrated allergen via nebulized droplets to the lungs. The starting dose of allergen will be 3 dose dilutions below the estimated PC20-allergen delivered for 5 minutes at tidal breathing, followed by FEV1 at 10-minute intervals until the lowest FEV1 is established. If the %FEV1 fall is < 20%, the next concentration is given, until the FEV1 falls ≥ 20%. When this happens the FEV1 will be followed at 10, 20, 30, 45, and 60 minutes, then hourly for 7 hours. The early asthmatic response is the maximum %FEV1 fall between 0 and 3 hours and the late asthmatic response between 3 and 7 hours post allergen challenge.~CT imaging, functional PET imaging: Physiology study using CT and PET imaging with Nitrogen-13 (13NN) saline as radiotracer; images obtained during the early and late phases after allergen challenge Nebulized methacholine inhalation: Standard"
204694|NCT01546922|O1|Outcome|Low Dose of Hydrocortisone|Results from the participants while receiving the low dose of hydrocortisone
204695|NCT01546922|E2|Reported Event|High Dose of HC|Administration of a high dose of hydrocortisone (0.4-0.6 mg/kg body weight) for 10 weeks
204696|NCT01546922|E1|Reported Event|Low Dose of HC|Administration of a low dose of hydrocortisone (0.2-0.3 mg/kg body weight) for 10 weeks
204697|NCT01546883|B1|Baseline|Dabigatran|Dabigatran
204698|NCT01546883|P1|Participant Flow|Dabigatran|"Patients with Atrial fibrillation taking Dabigatran etexilate as the anti-coagulant~Dabigatran etexilate (Pradaxa): 150mg bid or 75mg bid for a period of one year"
204661|NCT01547286|E1|Reported Event|Allergic Asthmatic|"Standardized Cat Allergen Extract and Standardized Dust Mite Allergen: The route of administration will be topical application of the titrated allergen via nebulized droplets to the lungs. The starting dose of allergen will be 3 dose dilutions below the estimated PC20-allergen delivered for 5 minutes at tidal breathing, followed by FEV1 at 10-minute intervals until the lowest FEV1 is established. If the %FEV1 fall is < 20%, the next concentration is given, until the FEV1 falls ≥ 20%. When this happens the FEV1 will be followed at 10, 20, 30, 45, and 60 minutes, then hourly for 7 hours. The early asthmatic response is the maximum %FEV1 fall between 0 and 3 hours and the late asthmatic response between 3 and 7 hours post allergen challenge.~CT imaging, functional PET imaging: Physiology study using CT and PET imaging with Nitrogen-13 (13NN) saline as radiotracer; images obtained during the early and late phases after allergen challenge"
204662|NCT01547247|B3|Baseline|Total|Total of all reporting groups
204663|NCT01547247|B2|Baseline|Water Immersion Colonoscopy|Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
204664|NCT01547247|B1|Baseline|Cap-assisted Water Immersion Colonoscopy|Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
204665|NCT01547247|P2|Participant Flow|Water Immersion Colonoscopy|Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
204666|NCT01547247|P1|Participant Flow|Cap-assisted Water Immersion Colonoscopy|Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
204667|NCT01547247|O2|Outcome|Water Immersion Colonoscopy|Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
204668|NCT01547247|O1|Outcome|Cap-assisted Water Immersion Colonoscopy|Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
204669|NCT01547247|O2|Outcome|Water Immersion Colonoscopy|Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
204670|NCT01547247|O1|Outcome|Cap-assisted Water Immersion Colonoscopy|Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
204671|NCT01547247|E2|Reported Event|Water Immersion Colonoscopy|Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
204672|NCT01547247|E1|Reported Event|Cap-assisted Water Immersion Colonoscopy|Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
204673|NCT01547130|B3|Baseline|Total|Total of all reporting groups
204674|NCT01547130|B2|Baseline|HalfLytely Colon Prep (HCP) Group|Patients followed the preparation method according to the manufacturer's standard instructions.
204675|NCT01547130|B1|Baseline|Shudh Colon Cleanse (SCC) Group|Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
204676|NCT01547130|P2|Participant Flow|HalfLytely Colon Prep (HCP)|Patients followed the preparation method according to the manufacturer's standard instructions.
204677|NCT01547130|P1|Participant Flow|Shudh Colon Cleanse (SCC) Group|Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
204678|NCT01547130|O2|Outcome|HalfLytely Colon Prep (HCP) Group|Patients followed the preparation method according to the manufacturer's standard instructions.
204679|NCT01547130|O1|Outcome|Shudh Colon Cleanse (SCC) Group|Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
204680|NCT01547130|O2|Outcome|HalfLytely Colon Prep (HCP) Group|Patients followed the preparation method according to the manufacturer's standard instructions. Subjects recorded adverse events.
204681|NCT01547130|O1|Outcome|Shudh Colon Cleanse (SCC) Group|Patients take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses. Adverse events were recorded on questionnaire.
204682|NCT01547130|O2|Outcome|HalfLytely Colon Prep (HCP) Group|Subjects rated the HCP as palatable
204683|NCT01547130|O1|Outcome|Shudh Colon Cleanse (SCC) Group|Subjects rated the SCC as palatable
204684|NCT01547130|O2|Outcome|HalfLytely Colon Prep (HCP) Group|Solution palatability of HCP by subjects based on 1-5 scale (1-not palatable and 5-Palatable). A questionnaire was used to collect the data.
204685|NCT01547130|O1|Outcome|Shudh Colon Cleanse (SCC) Group|Solution palatability of SCC by subjects based on 1-5 scale (1-not palatable and 5-Palatable). A questionnaire was used to collect the data.
204686|NCT01547130|O2|Outcome|HalfLytely Colon Prep (HCP) Group|Patients in the HCP group followed the preparation method according to the manufacturer's standard instructions. Patients were instructed to stay on clear liquids the entire day before the colonoscopy. Two tablets of bisacodyl delayed-release tablets with water were taken at around 1:00 pm. Patients were instructed to start drinking the solution after a bowel movement or around 7 pm if no bowel activity occurred. They were instructed to sip all of the solution at a rate of 8 oz. every 10 minutes.
204687|NCT01547130|O1|Outcome|Shudh Colon Cleanse (SCC) Group|Yoga contained a 32-oz plastic pitcher and 9-gm salt sachets (Iodine-free table salt - USP grade sodium chloride) for preparation of 0.9% saline (1 sachet in 32-oz lukewarm water (37.2-38.8 degrees Centigrade or 99-102 degrees Fahrenheit)), an instructional leaflet, and a DVD providing instructions of the bowel preparation process. Patients were instructed to fill the pitcher with 16-oz of hot water and 16-oz of room temperature water to reach the lukewarm temperature. Patients could add a twist of lemon if the solution was unpalatable to them.
204688|NCT01547130|E2|Reported Event|HalfLytely Colon Prep (HCP) Group|Patients followed the preparation method according to the manufacturer's standard instructions.
204689|NCT01547130|E1|Reported Event|Shudh Colon Cleanse (SCC) Group|Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
204690|NCT01546922|B1|Baseline|All Participants|All participants completing both study periods
204691|NCT01546922|P2|Participant Flow|First a High Dose of HC Followed by a Low Dose of HC|First high dose of hydrocortisone = 0.4-0.6 mg/kg body weight for 10 weeks followed by a low dose of hydrocortisone = 0.2-0.3 mg/kg body weight
204702|NCT01546688|B2|Baseline|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
204703|NCT01546688|B1|Baseline|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
204704|NCT01546688|P2|Participant Flow|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
204705|NCT01546688|P1|Participant Flow|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
204706|NCT01546688|O2|Outcome|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
204707|NCT01546688|O1|Outcome|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
204708|NCT01546688|O2|Outcome|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
204709|NCT01546688|O1|Outcome|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
204710|NCT01546688|O2|Outcome|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
204711|NCT01546688|O1|Outcome|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
204712|NCT01546688|O2|Outcome|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
204713|NCT01546688|O1|Outcome|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
204714|NCT01546688|E2|Reported Event|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
204715|NCT01546688|E1|Reported Event|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
204716|NCT01546675|B3|Baseline|Total|Total of all reporting groups
204717|NCT01546675|B2|Baseline|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design
204718|NCT01546675|B1|Baseline|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
204719|NCT01546675|P2|Participant Flow|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
204720|NCT01546675|P1|Participant Flow|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
204721|NCT01546675|O2|Outcome|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
204722|NCT01546675|O1|Outcome|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
204723|NCT01546675|O2|Outcome|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
204724|NCT01546675|O1|Outcome|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
204725|NCT01546675|O2|Outcome|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
204726|NCT01546675|O1|Outcome|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
204727|NCT01546675|O2|Outcome|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
204728|NCT01546675|O1|Outcome|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
204729|NCT01546675|O2|Outcome|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
204730|NCT01546675|O1|Outcome|Active Comparator: Traditional 1, Skeletal Stabilization 2|.Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
204731|NCT01546675|O2|Outcome|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
204732|NCT01546675|O1|Outcome|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
204733|NCT01546675|E1|Reported Event|Cases|Subjects using the Traditional Socket and socket hypothesized to increase skeletal stabilization in a case cross-over design.
204734|NCT01546649|B3|Baseline|Total|Total of all reporting groups
204735|NCT01546649|B2|Baseline|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
204736|NCT01546649|B1|Baseline|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
204737|NCT01546649|P2|Participant Flow|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
204738|NCT01546649|P1|Participant Flow|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
204739|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
204740|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
204741|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
204742|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
204743|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
204744|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
204745|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
204746|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
204747|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
204748|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
204749|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
204750|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
204751|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
204752|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
204753|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
204754|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
204755|NCT01546649|E2|Reported Event|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
204756|NCT01546649|E1|Reported Event|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
204757|NCT01546636|B3|Baseline|Total|Total of all reporting groups
204758|NCT01546636|B2|Baseline|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
204759|NCT01546636|B1|Baseline|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
204760|NCT01546636|P2|Participant Flow|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
204761|NCT01546636|P1|Participant Flow|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
204762|NCT01546636|O2|Outcome|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
204771|NCT01546623|B2|Baseline|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
204772|NCT01546623|B1|Baseline|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
204773|NCT01546623|P2|Participant Flow|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
204774|NCT01546623|P1|Participant Flow|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
204775|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
204776|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
204777|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
204778|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
204779|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
204780|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
204781|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
204782|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
204783|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
204784|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
204785|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
204786|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
204787|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
204788|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
204789|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
204790|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
204791|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
204792|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
204793|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
204794|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
204795|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
204796|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
204797|NCT01546623|E2|Reported Event|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
204798|NCT01546623|E1|Reported Event|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
204799|NCT01546519|B5|Baseline|Total|Total of all reporting groups
204800|NCT01546519|B4|Baseline|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204801|NCT01546519|B3|Baseline|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204802|NCT01546519|B2|Baseline|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204803|NCT01546519|B1|Baseline|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.~Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204804|NCT01546519|P4|Participant Flow|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204962|NCT01546038|O1|Outcome|Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)|AML participants who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS participants who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
205174|NCT01545700|O6|Outcome|Dexamethasone 8 mg 8-24 Hours|
205175|NCT01545700|O5|Outcome|Dexamethasone 4 mg 8-24 Hours|
204805|NCT01546519|P3|Participant Flow|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204806|NCT01546519|P2|Participant Flow|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204807|NCT01546519|P1|Participant Flow|Control Cohort With Normal Renal and Normal Hepatic Function|Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water.
204808|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204809|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204810|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204811|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water.
204812|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204813|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204814|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204815|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water.
204816|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204963|NCT01546038|O2|Outcome|Phase 2 Fit (Biomarker, Non-Responder)|AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
205176|NCT01545700|O4|Outcome|Placebo 8-24 Hours|
205177|NCT01545700|O3|Outcome|Dexamethasone 8 mg 0-4 Hours|
205178|NCT01545700|O2|Outcome|Dexamethasone 4 mg 0-4 Hours|
204817|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204818|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204819|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water.
204820|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204821|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204822|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204823|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water.
204824|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204825|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204826|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204827|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.~Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204828|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204964|NCT01546038|O1|Outcome|Phase 2 Fit (Biomarker, Responder)|AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
205179|NCT01545700|O1|Outcome|Placebo 0-4 Hours|Placebo 0-4 hours baseline
205180|NCT01545700|E2|Reported Event|Dexamethasone Group|either 4 mg or 8 mg
204829|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204830|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204831|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.~Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204832|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204833|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204834|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204835|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.~Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204836|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204837|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204838|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204839|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.~Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204840|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204965|NCT01546038|O2|Outcome|Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)|AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
205181|NCT01545700|E1|Reported Event|Control-saline Group|
205182|NCT01545518|B1|Baseline|All Subjects|"IVIG~IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover"
204841|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204842|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204843|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.~Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204844|NCT01546519|E4|Reported Event|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204845|NCT01546519|E3|Reported Event|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204846|NCT01546519|E2|Reported Event|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204847|NCT01546519|E1|Reported Event|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.~Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
204848|NCT01546454|B1|Baseline|All Study Participants|
204849|NCT01546454|P1|Participant Flow|All Study Participants|
204850|NCT01546454|O3|Outcome|Steroid Effects|"Estrogen/Progesterone replacement cycle versus Eligard treatment. Interventions include leuprolide acetate, estradiol, and progesterone.~leuprolide acetate: single 22.5 mg subcutaneous depot suspension~Estradiol: 0.05 to 0.3 mg transdermal daily for 26 days~Progesterone: 50 to 100 mg vaginal suppositories twice daily for 13 days"
204851|NCT01546454|O2|Outcome|Contraceptive Effects|"Oral contraceptive cycle versus Eligard treatment. Interventions include ethinyl estradiol-levonorgestrel combination and leuprolide acetate.~Ethinyl Estradiol-Levonorgestrel combination: 0.03 mg ethinyl estradiol, 0.15 mg levonorgestrel oral daily for 21 days~leuprolide acetate: single 22.5 mg subcutaneous depot suspension"
204852|NCT01546454|O1|Outcome|Non-steroidal Effects|"Natural menstrual cycle versus Estrogen/Progesterone replacement cycle. Interventions include leuprolide acetate to induce hypogonadism and estradiol and progesterone to replace hormone levels.~leuprolide acetate: single 22.5 mg subcutaneous depot suspension~Estradiol: 0.05 to 0.3 mg transdermal daily for 26 days~Progesterone: 50 to 100 mg vaginal suppositories twice daily for 13 days"
204853|NCT01546454|E1|Reported Event|All Study Participants|
204854|NCT01546402|B3|Baseline|Total|Total of all reporting groups
204855|NCT01546402|B2|Baseline|Phacoemulsification With Ozurdex|"This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration)."
204863|NCT01546402|E2|Reported Event|Phacoemulsification With Ozurdex|"This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration)."
204856|NCT01546402|B1|Baseline|Phacoemulsification With IOL Implant|"This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy."
204857|NCT01546402|P2|Participant Flow|Phacoemulsification With Ozurdex|"This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration)."
204858|NCT01546402|P1|Participant Flow|Phacoemulsification With IOL Implant|"This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy."
204859|NCT01546402|O2|Outcome|Phacoemulsification With Ozurdex|"This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration)."
204860|NCT01546402|O1|Outcome|Phacoemulsification With IOL Implant|"This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy."
204861|NCT01546402|O2|Outcome|Phacoemulsification With Ozurdex|"This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration)."
204862|NCT01546402|O1|Outcome|Phacoemulsification With IOL Implant|"This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy."
204899|NCT01546155|B1|Baseline|Healthy Volunteers|The PET/fMRI scan session will last up to 120 minutes. Subjects will have 2 MR-PET scan sessions, each lasting up to 120 minutes, with a break between scan sessions. Approximately nine venous blood samples will be taken per scan session with a maximum of 48mL of blood drawn per scan session. Intermittent cuff pain, based on the previously determined Strong ratings, will be applied during one of the two scan sessions. Subjects will rate the pain they feel as a result of the cuff stimuli using the Gracely scale. The additional scan session for subjects will be performed under no pain, “control” conditions.
205183|NCT01545518|P1|Participant Flow|All Subjects|"IVIG~IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover"
204864|NCT01546402|E1|Reported Event|Phacoemulsification With IOL Implant|"This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy."
204865|NCT01546285|B1|Baseline|Blood Pressure Reading|Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
204866|NCT01546285|P1|Participant Flow|Blood Pressure Reading|Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
204867|NCT01546285|O3|Outcome|B40 and PRO1000 - MAP|
204868|NCT01546285|O2|Outcome|B40 and PRO1000 - Diastolic BP|
204869|NCT01546285|O1|Outcome|B40 and PRO1000 - Systolic BP|Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
204870|NCT01546285|E1|Reported Event|Blood Pressure Reading|Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
204871|NCT01546207|B1|Baseline|Catheter-based Ablation|catheter ablation - a medical procedure used to treat some types of arrhythmia
204872|NCT01546207|P1|Participant Flow|Catheter-based Ablation|catheter ablation - a medical procedure used to treat some types of arrhythmia
204873|NCT01546207|O1|Outcome|Catheter-based Ablation|catheter ablation - a medical procedure used to treat some types of arrhythmia
204874|NCT01546207|E1|Reported Event|Catheter-based Ablation|catheter ablation - a medical procedure used to treat some types of arrhythmia
204875|NCT01546194|B3|Baseline|Total|Total of all reporting groups
204876|NCT01546194|B2|Baseline|Phone Call and Morning Consent|"Consent process consisting of information provided on the morning of surgery. In addition, a phone call on the day prior to surgery will be provided to subjects explaining that they will be approached about participation in a clinical research project~Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial"
204877|NCT01546194|B1|Baseline|Morning Consent|"Consent process consisting of information only provided on the morning of surgery~Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial"
204878|NCT01546194|P2|Participant Flow|Phone Call and Morning Consent|"Consent process consisting of information provided on the morning of surgery. In addition, a phone call on the day prior to surgery will be provided to subjects explaining that they will be approached about participation in a clinical research project~Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial"
204879|NCT01546194|P1|Participant Flow|Morning Consent|Consent process consisting of information only provided on the morning of surgery
204880|NCT01546194|O2|Outcome|Phone Call and Morning Consent|"Consent process consisting of information provided on the morning of surgery. In addition, a phone call on the day prior to surgery will be provided to subjects explaining that they will be approached about participation in a clinical research project~Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial"
204881|NCT01546194|O1|Outcome|Morning Consent|Consent process consisting of information only provided on the morning of surgery
204882|NCT01546194|E2|Reported Event|Phone Call and Morning Consent|"Consent process consisting of information provided on the morning of surgery. In addition, a phone call on the day prior to surgery will be provided to subjects explaining that they will be approached about participation in a clinical research project~Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial"
204883|NCT01546194|E1|Reported Event|Morning Consent|Consent process consisting of information only provided on the morning of surgery
204884|NCT01546168|B3|Baseline|Total|Total of all reporting groups
204885|NCT01546168|B2|Baseline|Temperature Monitoring|luminal esophageal standing temperature monitoring alone
204886|NCT01546168|B1|Baseline|Esophageal Deviation|esophageal deviation with IDE device during AF ablation
204887|NCT01546168|P2|Participant Flow|Temperature Monitoring|luminal esophageal standing temperature monitoring alone
204888|NCT01546168|P1|Participant Flow|Esophageal Deviation|esophageal deviation with IDE device during AF ablation
204889|NCT01546168|O2|Outcome|Temperature Monitoring|luminal esophageal standing temperature monitoring alone
204890|NCT01546168|O1|Outcome|Esophageal Deviation|esophageal deviation with IDE device during AF ablation
204891|NCT01546168|O2|Outcome|Temperature Monitoring|luminal esophageal standing temperature monitoring alone
204892|NCT01546168|O1|Outcome|Esophageal Deviation|esophageal deviation with IDE device during AF ablation
204893|NCT01546168|O2|Outcome|Temperature Monitoring|luminal esophageal standing temperature monitoring alone
204894|NCT01546168|O1|Outcome|Esophageal Deviation|esophageal deviation with IDE device during AF ablation
204895|NCT01546168|O2|Outcome|Temperature Monitoring|luminal esophageal standing temperature monitoring alone
204896|NCT01546168|O1|Outcome|Esophageal Deviation|esophageal deviation with IDE device during AF ablation
204897|NCT01546168|E2|Reported Event|Temperature Monitoring|luminal esophageal standing temperature monitoring alone
204898|NCT01546168|E1|Reported Event|Esophageal Deviation|esophageal deviation with IDE device during AF ablation
204940|NCT01546038|O3|Outcome|Phase 2 Unfit: LDAC Alone|Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28 day cycles.
204941|NCT01546038|O2|Outcome|Phase 2 Unfit: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.
204900|NCT01546155|P1|Participant Flow|Healthy Volunteers|The PET/fMRI scan session will last up to 120 minutes. Subjects will have 2 MR-PET scan sessions, each lasting up to 120 minutes, with a break between scan sessions. Approximately nine venous blood samples will be taken per scan session with a maximum of 48mL of blood drawn per scan session. Intermittent cuff pain, based on the previously determined Strong ratings, will be applied during one of the two scan sessions. Subjects will rate the pain they feel as a result of the cuff stimuli using the Gracely scale.
204901|NCT01546155|O1|Outcome|Healthy Controls|PET imaging: Up to a 120 minute PET scan using [11C]diprenorphine as the radiotracer
204902|NCT01546155|E1|Reported Event|Healthy Volunteers|PET imaging: Up to a 120 minute PET scan using [11C]diprenorphine as the radiotracer
204903|NCT01546142|B3|Baseline|Total|Total of all reporting groups
204904|NCT01546142|B2|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
204905|NCT01546142|B1|Baseline|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
204906|NCT01546142|P2|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
204907|NCT01546142|P1|Participant Flow|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
204908|NCT01546142|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
204909|NCT01546142|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
204910|NCT01546142|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
204911|NCT01546142|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
204912|NCT01546142|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
204913|NCT01546142|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
204914|NCT01546142|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
204915|NCT01546142|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
204916|NCT01546142|E2|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
204917|NCT01546142|E1|Reported Event|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
204918|NCT01546038|B7|Baseline|Total|Total of all reporting groups
204919|NCT01546038|B6|Baseline|Phase 2 Unfit: LDAC Alone|Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28-day cycles.
204920|NCT01546038|B5|Baseline|Phase 2 Unfit: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles.
204921|NCT01546038|B4|Baseline|Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
204922|NCT01546038|B3|Baseline|Phase 1B: Glasdegib + Cytarabine/Daunorubicin|Included all participants who received oral glasdegib in combination with cytarabine/daunorubicin in phase 1B portion.
204923|NCT01546038|B2|Baseline|Phase 1B: Glasdegib + Decitabine|Included all participants who received oral glasdegib in combination with decitabine in phase 1B portion.
204924|NCT01546038|B1|Baseline|Phase 1B: Glasdegib + LDAC|Included all participants who received oral glasdegib in combination with LDAC in phase 1B portion.
204925|NCT01546038|P9|Participant Flow|Phase 2 Unfit: LDAC Alone|Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28-day cycles.
204926|NCT01546038|P8|Participant Flow|Phase 2 Unfit: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles.
204959|NCT01546038|O2|Outcome|Phase 1B: Glasdegib + Decitabine|Included all participants who received oral glasdegib in combination with decitabine in phase 1B portion.
204960|NCT01546038|O1|Outcome|Phase 1B: Glasdegib + LDAC|Included all participants who received oral glasdegib in combination with LDAC in phase 1B portion.
204961|NCT01546038|O2|Outcome|Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)|AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
204927|NCT01546038|P7|Participant Flow|Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
204928|NCT01546038|P6|Participant Flow|Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 200 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg.One (1) participant in this cohort had dose reduction to 100 mg starting from Consolidation Cycle 1/Day 21.
204929|NCT01546038|P5|Participant Flow|Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
204930|NCT01546038|P4|Participant Flow|Phase 1B: Glasdegib 200 mg + Decitabine|Participants received oral doses of glasdegib tablets 200 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m^2 as an IV infusion over 1 hour on Days 1-5 of the 28-day cycles.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 1/Day 24 and Cycle 5/Day 1, respectively.
204931|NCT01546038|P3|Participant Flow|Phase 1B: Glasdegib 100 mg + Decitabine|Participants received oral doses of glasdegib tablets 100 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m^2 as an intravenous (IV) infusion over 1 hour on Days 1-5 of the 28-day cycles.
204932|NCT01546038|P2|Participant Flow|Phase 1B: Glasdegib 200 mg + LDAC|Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.
204933|NCT01546038|P1|Participant Flow|Phase 1B: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib (PF-04449913) tablets 100 milligram (mg) starting on Day 3 of Cycle 1 for pharmacokinetic (PK) assessment purposes and thereafter once daily (QD) and continuously for 28-day cycles (starting on Day 1 for all other cycles). Low dose Ara-C (LDAC) was given at a dose of 20 mg subcutaneously twice daily (BID) on Days 1-10 of the 28-day cycles.
204934|NCT01546038|O3|Outcome|Phase 2 Unfit: LDAC Alone|Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28 day cycles.
204935|NCT01546038|O2|Outcome|Phase 2 Unfit: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.
204936|NCT01546038|O1|Outcome|Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
204937|NCT01546038|O3|Outcome|Phase 2 Unfit: LDAC Alone|Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28 day cycles.
204938|NCT01546038|O2|Outcome|Phase 2 Unfit: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.
204939|NCT01546038|O1|Outcome|Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
204942|NCT01546038|O1|Outcome|Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
204943|NCT01546038|O6|Outcome|Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 200 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg.One (1) participant in this cohort had dose reduction to 100 mg starting from Consolidation Cycle 1/Day 21.
204944|NCT01546038|O5|Outcome|Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
204945|NCT01546038|O4|Outcome|Phase 1B: Glasdegib 200 mg + Decitabine|Participants received oral doses of glasdegib tablets 200 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m^2 as an IV infusion over 1 hour on Days 1-5 of the 28-day cycles.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 1/Day 24 and Cycle 5/Day 1, respectively.
204946|NCT01546038|O3|Outcome|Phase 1B: Glasdegib 100 mg + Decitabine|Participants received oral doses of glasdegib tablets 100 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m^2 as an intravenous (IV) infusion over 1 hour on Days 1-5 of the 28-day cycles.
204947|NCT01546038|O2|Outcome|Phase 1B: Glasdegib 200 mg + LDAC|Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.
204948|NCT01546038|O1|Outcome|Phase 1B: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib (PF-04449913) tablets 100 milligram (mg) starting on Day 3 of Cycle 1 for pharmacokinetic (PK) assessment purposes and thereafter once daily (QD) and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously twice daily (BID) on Days 1-10 of the 28-day cycles.
204949|NCT01546038|O3|Outcome|Phase 1B: Glasdegib + Cytarabine/Daunorubicin|Included all participants who received oral glasdegib in combination with cytarabine/daunorubicin in phase 1B portion.
204950|NCT01546038|O2|Outcome|Phase 1B: Glasdegib + Decitabine|Included all participants who received oral glasdegib in combination with decitabine in phase 1B portion.
204951|NCT01546038|O1|Outcome|Phase 1B: Glasdegib + LDAC|Included all participants who received oral glasdegib in combination with LDAC in phase 1B portion.
204952|NCT01546038|O3|Outcome|Phase 1B: Glasdegib + Cytarabine/Daunorubicin|Included all participants who received oral glasdegib in combination with cytarabine/daunorubicin in phase 1B portion.
204953|NCT01546038|O2|Outcome|Phase 1B: Glasdegib + Decitabine|Included all participants who received oral glasdegib in combination with decitabine in phase 1B portion.
204954|NCT01546038|O1|Outcome|Phase 1B: Glasdegib + LDAC|Included all participants who received oral glasdegib in combination with LDAC in phase 1B portion.
204955|NCT01546038|O3|Outcome|Phase 2 Unfit: LDAC Alone|Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28 day cycles.
204956|NCT01546038|O2|Outcome|Phase 2 Unfit: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.
204957|NCT01546038|O1|Outcome|Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
204958|NCT01546038|O3|Outcome|Phase 1B: Glasdegib + Cytarabine/Daunorubicin|Included all participants who received oral glasdegib in combination with cytarabine/daunorubicin in phase 1B portion.
206226|NCT01541969|E2|Reported Event|Tinnitus Masking|see Protocol section for details
204966|NCT01546038|O1|Outcome|Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)|AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
204967|NCT01546038|O2|Outcome|Phase 2 Fit (Biomarker, Non-Responder)|AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
204968|NCT01546038|O1|Outcome|Phase 2 Fit (Biomarker, Responder)|AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
204969|NCT01546038|O1|Outcome|Phase 2 Unfit: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.
204970|NCT01546038|O1|Outcome|Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
204971|NCT01546038|O1|Outcome|Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
204972|NCT01546038|O2|Outcome|Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)|AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
204973|NCT01546038|O1|Outcome|Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)|AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
204974|NCT01546038|O2|Outcome|Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)|AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
204975|NCT01546038|O1|Outcome|Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)|AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
204976|NCT01546038|O2|Outcome|Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)|AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
204977|NCT01546038|O1|Outcome|Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)|AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
204978|NCT01546038|O2|Outcome|Phase 2 Unfit: LDAC Alone|Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28 day cycles.
204979|NCT01546038|O1|Outcome|Phase 2 Unfit: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.
204980|NCT01546038|O1|Outcome|Phase 2 Unfit: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.
204981|NCT01546038|O2|Outcome|Phase 2 Fit (Biomarker, Non-Responder)|AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
204982|NCT01546038|O1|Outcome|Phase 2 Fit (Biomarker, Responder)|AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
204983|NCT01546038|O2|Outcome|Phase 2 Fit (Biomarker, Non-Responder)|AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
204984|NCT01546038|O1|Outcome|Phase 2 Fit (Biomarker, Responder)|AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
204985|NCT01546038|O2|Outcome|Phase 2 Fit (Biomarker, Non-Responder)|AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
204986|NCT01546038|O1|Outcome|Phase 2 Fit (Biomarker, Responder)|AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
204987|NCT01546038|O2|Outcome|Phase 2 Fit (Biomarker, Non-Responder)|AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
204988|NCT01546038|O1|Outcome|Phase 2 Fit (Biomarker, Responder)|AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
205184|NCT01545518|O1|Outcome|All Subjects|"IVIG~IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover"
204989|NCT01546038|O1|Outcome|Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
204990|NCT01546038|O1|Outcome|Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
204991|NCT01546038|O1|Outcome|Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
204992|NCT01546038|O1|Outcome|Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
204993|NCT01546038|O1|Outcome|Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
204994|NCT01546038|O6|Outcome|Phase 2 Unfit: LDAC Alone (Biomarker, Non-Responder)|AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
204995|NCT01546038|O5|Outcome|Phase 2 Unfit: LDAC Alone (Biomarker, Responder)|AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
204996|NCT01546038|O4|Outcome|Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)|AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
204997|NCT01546038|O3|Outcome|Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)|AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
204998|NCT01546038|O2|Outcome|Phase 2 Fit (Biomarker,Non-Responder)|AML participants who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS participants who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
204999|NCT01546038|O1|Outcome|Phase 2 Fit (Biomarker, Responder)|AML participants who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS participants who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
205000|NCT01546038|O2|Outcome|Phase 1B: Glasdegib+Cytarabine/Dauno(Biomarker,Non-Responder)|AML participants who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS participants who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response. Dauno is short for daunorubicin.
205001|NCT01546038|O1|Outcome|Phase 1B: Glasdegib + Cytarabine/Dauno (Biomarker, Responder)|AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response). Dauno is short for daunorubicin.
205002|NCT01546038|O2|Outcome|Phase 1B: Glasdegib+Cytarabine/Dauno(Biomarker,Non-Responder)|AML participants who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS participants who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response. Dauno is short for daunorubicin.
205003|NCT01546038|O1|Outcome|Phase 1B: Glasdegib + Cytarabine/Dauno (Biomarker, Responder)|AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response). Dauno is short for daunorubicin.
205004|NCT01546038|O2|Outcome|Phase 1B: Glasdegib+Cytarabine/Dauno(Biomarker,Non-Responder)|AML participants who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS participants who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response. Dauno is short for daunorubicin.
205185|NCT01545518|E1|Reported Event|All Subjects|"IVIG~IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover~No AE's."
205186|NCT01545388|B4|Baseline|Total|Total of all reporting groups
205005|NCT01546038|O1|Outcome|Phase 1B: Glasdegib + Cytarabine/Dauno (Biomarker, Responder)|AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response). Dauno is short for daunorubicin.
205006|NCT01546038|O1|Outcome|Phase 1B: Glasdegib + Cytarabine/Daunorubicin|Included all participants who received oral glasdegib in combination with cytarabine/daunorubicin in phase 1B portion.
205007|NCT01546038|O1|Outcome|Phase 1B: Glasdegib + Cytarabine/Daunorubicin|Included all participants who received oral glasdegib in combination with cytarabine/daunorubicin in phase 1B portion.
205008|NCT01546038|O1|Outcome|Phase 1B: Glasdegib + Cytarabine/Daunorubicin|Included all participants who received oral glasdegib in combination with cytarabine/daunorubicin in phase 1B portion.
205009|NCT01546038|O6|Outcome|Phase 1B: Glasdegib+Cytarabine/Dauno(Biomarker,Non-Responder)|AML participants who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS participants who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response. Dauno is short for daunorubicin.
205010|NCT01546038|O5|Outcome|Phase 1B: Glasdegib + Cytarabine/Dauno (Biomarker, Responder)|AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response). Dauno is short for daunorubicin.
205011|NCT01546038|O4|Outcome|Phase 1B: Glasdegib + Decitabine (Biomaker,Non-Responder)|AML participants who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS participants who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
205012|NCT01546038|O3|Outcome|Phase 1B: Glasdegib + Decitabine (Biomarker,Responder)|AML participants who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS participants who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
205013|NCT01546038|O2|Outcome|Phase 1B: Glasdegib + LDAC (Biomarker, Non-Responder)|AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
205014|NCT01546038|O1|Outcome|Phase 1B: Glasdegib + LDAC (Biomarker, Responder)|AML participants who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS participants who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
205015|NCT01546038|O1|Outcome|Phase 2 Unfit: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.
205016|NCT01546038|O1|Outcome|Phase 2 Unfit: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.
205017|NCT01546038|O1|Outcome|Phase 2 Unfit: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.
205018|NCT01546038|O1|Outcome|Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
205019|NCT01546038|O2|Outcome|Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 200 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg.One (1) participant in this cohort had dose reduction to 100 mg starting from Consolidation Cycle 1/Day 21.
205020|NCT01546038|O1|Outcome|Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
205021|NCT01546038|O2|Outcome|Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 200 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg.One (1) participant in this cohort had dose reduction to 100 mg starting from Consolidation Cycle 1/Day 21.
205075|NCT01546038|O1|Outcome|Phase 2 Unfit: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.
205022|NCT01546038|O1|Outcome|Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
205023|NCT01546038|O2|Outcome|Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 200 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg.One (1) participant in this cohort had dose reduction to 100 mg starting from Consolidation Cycle 1/Day 21.
205024|NCT01546038|O1|Outcome|Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
205025|NCT01546038|O2|Outcome|Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 200 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg.One (1) participant in this cohort had dose reduction to 100 mg starting from Consolidation Cycle 1/Day 21.
205026|NCT01546038|O1|Outcome|Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
205027|NCT01546038|O2|Outcome|Phase 1B: Glasdegib 200 mg + Decitabine|Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.
205028|NCT01546038|O1|Outcome|Phase 1B: Glasdegib 100 mg + Decitabine|Participants received oral doses of glasdegib tablets 100 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m^2 as an intravenous (IV) infusion over 1 hour on Days 1-5 of the 28-day cycles.
205029|NCT01546038|O2|Outcome|Phase 1B: Glasdegib 200 mg + Decitabine|Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.
205030|NCT01546038|O1|Outcome|Phase 1B: Glasdegib 100 mg + Decitabine|Participants received oral doses of glasdegib tablets 100 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m^2 as an intravenous (IV) infusion over 1 hour on Days 1-5 of the 28-day cycles.
205031|NCT01546038|O2|Outcome|Phase 1B: Glasdegib 200 mg + Decitabine|Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.
205112|NCT01545843|O2|Outcome|Late Bedtime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay in bedtime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205032|NCT01546038|O1|Outcome|Phase 1B: Glasdegib 100 mg + Decitabine|Participants received oral doses of glasdegib tablets 100 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m^2 as an intravenous (IV) infusion over 1 hour on Days 1-5 of the 28-day cycles.
205033|NCT01546038|O2|Outcome|Phase 1B: Glasdegib 200 mg + LDAC|Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.
205034|NCT01546038|O1|Outcome|Phase 1B: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib (PF-04449913) tablets 100 milligram (mg) starting on Day 3 of Cycle 1 for pharmacokinetic (PK) assessment purposes and thereafter once daily (QD) and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously twice daily (BID) on Days 1-10 of the 28-day cycles.
205035|NCT01546038|O2|Outcome|Phase 1B: Glasdegib 200 mg + LDAC|Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.
205036|NCT01546038|O1|Outcome|Phase 1B: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib (PF-04449913) tablets 100 milligram (mg) starting on Day 3 of Cycle 1 for pharmacokinetic (PK) assessment purposes and thereafter once daily (QD) and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously twice daily (BID) on Days 1-10 of the 28-day cycles.
205037|NCT01546038|O2|Outcome|Phase 1B: Glasdegib 200 mg + LDAC|Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.
205038|NCT01546038|O1|Outcome|Phase 1B: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib (PF-04449913) tablets 100 milligram (mg) starting on Day 3 of Cycle 1 for pharmacokinetic (PK) assessment purposes and thereafter once daily (QD) and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously twice daily (BID) on Days 1-10 of the 28-day cycles.
205039|NCT01546038|O2|Outcome|Phase 1B: Glasdegib 200 mg + LDAC|Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.
205040|NCT01546038|O1|Outcome|Phase 1B: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib (PF-04449913) tablets 100 milligram (mg) starting on Day 3 of Cycle 1 for pharmacokinetic (PK) assessment purposes and thereafter once daily (QD) and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously twice daily (BID) on Days 1-10 of the 28-day cycles.
205041|NCT01546038|O2|Outcome|Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 200 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg.One (1) participant in this cohort had dose reduction to 100 mg starting from Consolidation Cycle 1/Day 21.
205042|NCT01546038|O1|Outcome|Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
205053|NCT01546038|O2|Outcome|Phase 1B: Glasdegib 200 mg + LDAC|Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.
205409|NCT01544582|E3|Reported Event|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
205043|NCT01546038|O2|Outcome|Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 200 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg.One (1) participant in this cohort had dose reduction to 100 mg starting from Consolidation Cycle 1/Day 21.
205044|NCT01546038|O1|Outcome|Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
205045|NCT01546038|O2|Outcome|Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 200 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg.One (1) participant in this cohort had dose reduction to 100 mg starting from Consolidation Cycle 1/Day 21.
205046|NCT01546038|O1|Outcome|Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
205047|NCT01546038|O2|Outcome|Phase 1B: Glasdegib 200 mg + Decitabine|Participants received oral doses of glasdegib tablets 200 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m^2 as an IV infusion over 1 hour on Days 1-5 of the 28-day cycles.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 1/Day 24 and Cycle 5/Day 1, respectively.
205048|NCT01546038|O1|Outcome|Phase 1B: Glasdegib 100 mg + Decitabine|Participants received oral doses of glasdegib tablets 100 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m^2 as an intravenous (IV) infusion over 1 hour on Days 1-5 of the 28-day cycles.
205049|NCT01546038|O2|Outcome|Phase 1B: Glasdegib 200 mg + Decitabine|Participants received oral doses of glasdegib tablets 200 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m^2 as an IV infusion over 1 hour on Days 1-5 of the 28-day cycles.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 1/Day 24 and Cycle 5/Day 1, respectively.
205050|NCT01546038|O1|Outcome|Phase 1B: Glasdegib 100 mg + Decitabine|Participants received oral doses of glasdegib tablets 100 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m^2 as an intravenous (IV) infusion over 1 hour on Days 1-5 of the 28-day cycles.
205051|NCT01546038|O2|Outcome|Phase 1B: Glasdegib 200 mg + Decitabine|Participants received oral doses of glasdegib tablets 200 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m^2 as an IV infusion over 1 hour on Days 1-5 of the 28-day cycles.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 1/Day 24 and Cycle 5/Day 1, respectively.
205052|NCT01546038|O1|Outcome|Phase 1B: Glasdegib 100 mg + Decitabine|Participants received oral doses of glasdegib tablets 100 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m^2 as an intravenous (IV) infusion over 1 hour on Days 1-5 of the 28-day cycles.
205054|NCT01546038|O1|Outcome|Phase 1B: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib (PF-04449913) tablets 100 milligram (mg) starting on Day 3 of Cycle 1 for pharmacokinetic (PK) assessment purposes and thereafter once daily (QD) and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously twice daily (BID) on Days 1-10 of the 28-day cycles.
205410|NCT01544582|E2|Reported Event|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
205055|NCT01546038|O2|Outcome|Phase 1B: Glasdegib 200 mg + LDAC|Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.
205056|NCT01546038|O1|Outcome|Phase 1B: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib (PF-04449913) tablets 100 milligram (mg) starting on Day 3 of Cycle 1 for pharmacokinetic (PK) assessment purposes and thereafter once daily (QD) and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously twice daily (BID) on Days 1-10 of the 28-day cycles.
205057|NCT01546038|O2|Outcome|Phase 1B: Glasdegib 200 mg + LDAC|Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.
205058|NCT01546038|O1|Outcome|Phase 1B: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib (PF-04449913) tablets 100 milligram (mg) starting on Day 3 of Cycle 1 for pharmacokinetic (PK) assessment purposes and thereafter once daily (QD) and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously twice daily (BID) on Days 1-10 of the 28-day cycles.
205059|NCT01546038|O3|Outcome|Phase 2 Unfit: LDAC Alone|Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28 day cycles.
205060|NCT01546038|O2|Outcome|Phase 2 Unfit: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.
205061|NCT01546038|O1|Outcome|Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
205062|NCT01546038|O3|Outcome|Phase 2 Unfit: LDAC Alone|Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28 day cycles.
205063|NCT01546038|O2|Outcome|Phase 2 Unfit: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.
205064|NCT01546038|O1|Outcome|Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
205065|NCT01546038|O2|Outcome|Phase 2 Unfit: LDAC Alone|Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28 day cycles.
205066|NCT01546038|O1|Outcome|Phase 2 Unfit: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.
205067|NCT01546038|O3|Outcome|Phase 1B: Glasdegib + Cytarabine/Daunorubicin|Included all participants who received oral glasdegib in combination with cytarabine/daunorubicin in phase 1B portion.
205068|NCT01546038|O2|Outcome|Phase 1B: Glasdegib + Decitabine|Included all participants who received oral glasdegib in combination with decitabine in phase 1B portion.
205069|NCT01546038|O1|Outcome|Phase 1B: Glasdegib + LDAC|Included all participants who received oral glasdegib in combination with LDAC in phase 1B portion.
205070|NCT01546038|O1|Outcome|Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
205071|NCT01546038|O3|Outcome|Phase 1B: Glasdegib + Cytarabine/Daunorubicin|Included all participants who received oral glasdegib in combination with cytarabine/daunorubicin in phase 1B portion.
205072|NCT01546038|O2|Outcome|Phase 1B: Glasdegib + Decitabine|Included all participants who received oral glasdegib in combination with decitabine in phase 1B portion.
205073|NCT01546038|O1|Outcome|Phase 1B: Glasdegib + LDAC|Included all participants who received oral glasdegib in combination with LDAC in phase 1B portion.
205074|NCT01546038|O2|Outcome|Phase 2 Unfit: LDAC Alone|Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28 day cycles.
205411|NCT01544582|E1|Reported Event|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
205076|NCT01546038|O1|Outcome|Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
205077|NCT01546038|O6|Outcome|Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 200 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg.One (1) participant in this cohort had dose reduction to 100 mg starting from Consolidation Cycle 1/Day 21.
205078|NCT01546038|O5|Outcome|Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
205079|NCT01546038|O4|Outcome|Phase 1B: Glasdegib 200 mg + Decitabine|Participants received oral doses of glasdegib tablets 200 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m^2 as an IV infusion over 1 hour on Days 1-5 of the 28-day cycles.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 1/Day 24 and Cycle 5/Day 1, respectively.
205080|NCT01546038|O3|Outcome|Phase 1B: Glasdegib 100 mg + Decitabine|Participants received oral doses of glasdegib tablets 100 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m^2 as an intravenous (IV) infusion over 1 hour on Days 1-5 of the 28-day cycles.
205081|NCT01546038|O2|Outcome|Phase 1B: Glasdegib 200 mg + LDAC|Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.
205082|NCT01546038|O1|Outcome|Phase 1B: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib (PF-04449913) tablets 100 milligram (mg) starting on Day 3 of Cycle 1 for pharmacokinetic (PK) assessment purposes and thereafter once daily (QD) and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously twice daily (BID) on Days 1-10 of the 28-day cycles.
205083|NCT01546038|E9|Reported Event|Phase 2 Unfit: LDAC Alone|Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28-day cycles.
205084|NCT01546038|E8|Reported Event|Phase 2 Unfit: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles.
205085|NCT01546038|E7|Reported Event|Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
205086|NCT01546038|E6|Reported Event|Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 200 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg.One (1) participant in this cohort had dose reduction to 100 mg starting from Consolidation Cycle 1/Day 21.
205113|NCT01545843|O1|Outcome|No Sleep Deprivation|"8 hours time in bed plus medication~Sleep scheduling: 8 hours time in bed for 2 weeks~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205187|NCT01545388|B3|Baseline|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
205087|NCT01546038|E5|Reported Event|Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
205088|NCT01546038|E4|Reported Event|Phase 1B: Glasdegib 200 mg + Decitabine|Participants received oral doses of glasdegib tablets 200 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m^2 as an IV infusion over 1 hour on Days 1-5 of the 28-day cycles.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 1/Day 24 and Cycle 5/Day 1, respectively.
205089|NCT01546038|E3|Reported Event|Phase 1B: Glasdegib 100 mg + Decitabine|Participants received oral doses of glasdegib tablets 100 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m^2 as an intravenous (IV) infusion over 1 hour on Days 1-5 of the 28-day cycles.
205090|NCT01546038|E2|Reported Event|Phase 1B: Glasdegib 200 mg + LDAC|Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.
205091|NCT01546038|E1|Reported Event|Phase 1B: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib (PF-04449913) tablets 100 milligram (mg) starting on Day 3 of Cycle 1 for pharmacokinetic (PK) assessment purposes and thereafter once daily (QD) and continuously for 28-day cycles (starting on Day 1 for all other cycles). Low dose Ara-C (LDAC) was given at a dose of 20 mg subcutaneously twice daily (BID) on Days 1-10 of the 28-day cycles.
205092|NCT01545843|B4|Baseline|Total|Total of all reporting groups
205093|NCT01545843|B3|Baseline|Early Risetime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling:6 hours time in bed for two weeks; risetime advanced by 2 hours~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205094|NCT01545843|B2|Baseline|Late Bedtime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling:6 hours time in bed for two weeks; bedtime delayed by 2 hours~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205095|NCT01545843|B1|Baseline|No Sleep Deprivation|"8 hours time in bed plus medication~Sleep scheduling: 8 hours time in bed for two weeks~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205096|NCT01545843|P3|Participant Flow|Early Risetime Sleep Deprivation|6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Rise time advanced by 2 hours.
205097|NCT01545843|P2|Participant Flow|Late Bedtime Sleep Deprivation|6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Bedtime delayed by 2 hours.
205098|NCT01545843|P1|Participant Flow|No Sleep Deprivation|8 hours time in bed for two weeks plus fluoxetine for 8 weeks
205099|NCT01545843|O3|Outcome|Early Risetime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance in risetime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205100|NCT01545843|O2|Outcome|Late Bedtime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay in bedtime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205101|NCT01545843|O1|Outcome|No Sleep Deprivation|"8 hours time in bed plus medication~Sleep scheduling: 8 hours time in bed for 2 weeks~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205102|NCT01545843|O3|Outcome|Early Risetime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance in risetime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205103|NCT01545843|O2|Outcome|Late Bedtime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay in bedtime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205104|NCT01545843|O1|Outcome|No Sleep Deprivation|"8 hours time in bed plus medication~Sleep scheduling: 8 hours time in bed for 2 weeks~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205105|NCT01545843|O3|Outcome|Early Risetime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance of risetime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205106|NCT01545843|O2|Outcome|Late Bedtime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay of bedtime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205107|NCT01545843|O1|Outcome|No Sleep Deprivation|"8 hours time in bed plus medication~Sleep scheduling: 8 hours vs. 6 hours time in bed for two weeks~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205108|NCT01545843|O3|Outcome|Early Risetime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance of risetime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205109|NCT01545843|O2|Outcome|Late Bedtime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay of bedtime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205110|NCT01545843|O1|Outcome|No Sleep Deprivation|"8 hours time in bed plus medication~Sleep scheduling: 8 hours vs. 6 hours time in bed for two weeks~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205111|NCT01545843|O3|Outcome|Early Risetime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance in risetime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205163|NCT01545700|O11|Outcome|Dexamethasone 8 mg 0-4 Hours-baseline|
205114|NCT01545843|O3|Outcome|Early Risetime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance of risetime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205115|NCT01545843|O2|Outcome|Late Bedtime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay of bedtime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205116|NCT01545843|O1|Outcome|No Sleep Deprivation|"8 hours time in bed plus medication~Sleep scheduling: 8 hours vs. 6 hours time in bed for two weeks~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205117|NCT01545843|O3|Outcome|Early Risetime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance of risetime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205118|NCT01545843|O2|Outcome|Late Bedtime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay of bedtime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205119|NCT01545843|O1|Outcome|No Sleep Deprivation|"8 hours time in bed plus medication~Sleep scheduling: 8 hours vs. 6 hours time in bed for two weeks~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205120|NCT01545843|O3|Outcome|Early Risetime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance in risetime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205121|NCT01545843|O2|Outcome|Late Bedtime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay in bedtime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205122|NCT01545843|O1|Outcome|No Sleep Deprivation|"8 hours time in bed plus medication~Sleep scheduling: 8 hours time in bed for 2 weeks~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205123|NCT01545843|E3|Reported Event|Early Risetime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, two hour advance of risetime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205124|NCT01545843|E2|Reported Event|Late Bedtime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, two hour delay of bedtime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205125|NCT01545843|E1|Reported Event|No Sleep Deprivation|"8 hours time in bed plus medication~Sleep scheduling: 8 hours time in bed for two weeks~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
205126|NCT01545765|B1|Baseline|Lidocaine 7% and Tetracaine 7%|
205127|NCT01545765|P1|Participant Flow|Face 2 Application Times/ Thight 2 Application Times|
205128|NCT01545765|O4|Outcome|Lidocaine 7% + Tetracaine 7% Thigh - Second Application Time|
205129|NCT01545765|O3|Outcome|Lidocaine 7% + Tetracaine 7% Thigh - First Application Time|
205130|NCT01545765|O2|Outcome|Lidocaine 7% + Tetracaine 7% Face - Second Application Time|
205131|NCT01545765|O1|Outcome|Lidocaine 7% + Tetracaine 7% Face - First Application Time|
205132|NCT01545765|O4|Outcome|Lidocaine 7% + Tetracaine 7% Thigh - Second Application Time|
205133|NCT01545765|O3|Outcome|Lidocaine 7% + Tetracaine 7% Thigh - First Application Time|
205134|NCT01545765|O2|Outcome|Lidocaine 7% + Tetracaine 7% Face - Second Application Time|
205135|NCT01545765|O1|Outcome|Lidocaine 7% + Tetracaine 7% Face - First Application Time|
205136|NCT01545765|E1|Reported Event|Lidocaine 7% + Tetracaine 7%|
205137|NCT01545700|B7|Baseline|Total|Total of all reporting groups
205138|NCT01545700|B6|Baseline|Dexamethasone 8 mg, 8-24 Hours|"Dexamethasone 8 mg administered intraoperatively~Dexamethasone 8 mg : Patients are randomized to receive dexamethasone 8 mg"
205139|NCT01545700|B5|Baseline|Dexamethasone 4 mg, 8-24 Hours|"Dexamethasone 4 mg administered intraoperatively~Dexamethasone 4 mg : Patients are randomized to receive dexamethasone 4 mg and saline 1 cc"
205140|NCT01545700|B4|Baseline|Placebo Comparator Saline 8-24 Hours|"placebo, 2 cc saline~Control saline : Patients are randomized to receive saline 2 cc"
205141|NCT01545700|B3|Baseline|Dexamethasone 8 mg, 0-4 Hours|"Dexamethasone 8 mg administered intraoperatively~Dexamethasone 8 mg : Patients randomized to receive dexamethasone 8mg"
205142|NCT01545700|B2|Baseline|Dexamethasone 4 mg, 0-4 Hours|"Dexamethasone 4 mg administered intraoperatively~Dexamethasone 4 mg : Patients randomized to receive dexamethasone 4mg and 1 cc saline"
205143|NCT01545700|B1|Baseline|Control, Saline 0-4 Hours|"2 cc of saline~Control-saline : Patients are randomized to receive saline 2 cc"
205144|NCT01545700|P6|Participant Flow|Dexamethasone 8 mg, 8-24 Hours|"Dexamethasone 8 mg administered intraoperatively~Dexamethasone 8 mg : Patients are randomized to receive dexamethasone 8 mg"
205145|NCT01545700|P5|Participant Flow|Dexamethasone 4 mg, 8-24 Hours|"Dexamethasone 4 mg administered intraoperatively~Dexamethasone 4 mg : Patients are randomized to receive dexamethasone 4 mg and saline 1 cc"
205146|NCT01545700|P4|Participant Flow|Placebo Comparator Saline 8-24 Hours|"placebo, 2 cc saline~Control saline : Patients are randomized to receive saline 2 cc"
205147|NCT01545700|P3|Participant Flow|Dexamethasone 8 mg, 0-4 Hours|"Dexamethasone 8 mg administered intraoperatively~Dexamethasone 8 mg : Patients randomized to receive dexamethasone 8mg"
205148|NCT01545700|P2|Participant Flow|Dexamethasone 4 mg, 0-4 Hours|"Dexamethasone 4 mg administered intraoperatively~Dexamethasone 4 mg : Patients randomized to receive dexamethasone 4mg and 1 cc saline"
205149|NCT01545700|P1|Participant Flow|Control, Saline 0-4 Hours|"2 cc of saline~Control-saline : Patients are randomized to receive saline 2 cc"
205150|NCT01545700|O24|Outcome|Dexamethasone 8 mg 8-24 Hours-24 Hours|
205151|NCT01545700|O23|Outcome|Dexamethasone 8 mg 8-24 Hours-8 Hours|
205152|NCT01545700|O22|Outcome|Dexamethasone 8 mg 8-24 Hours-baseline|
205153|NCT01545700|O21|Outcome|Dexamethasone 4 mg 8-24 Hours-24 Hours|
205154|NCT01545700|O20|Outcome|Dexamethasone 4 mg 8-24 Hours-8 Hours|
205155|NCT01545700|O19|Outcome|Dexamethasone 4 mg 8-24 Hours-baseline|
205156|NCT01545700|O18|Outcome|Placebo 8-24 Hours-24 Hours|
205157|NCT01545700|O17|Outcome|Placebo 8-24 Hours-8 Hours|
205158|NCT01545700|O16|Outcome|Placebo 8-24 Hours Baseline|
205159|NCT01545700|O15|Outcome|Dexamethasone 8 mg 0-4 Hours-4 Hours|
205160|NCT01545700|O14|Outcome|Dexamethasone 8 mg 0-4 Hours-3 Hours|
205161|NCT01545700|O13|Outcome|Dexamethasone 8 mg 0-4 Hours-2 Hours|
205162|NCT01545700|O12|Outcome|Dexamethasone 8 mg 0-4 Hours-1 Hour|
205188|NCT01545388|B2|Baseline|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
205189|NCT01545388|B1|Baseline|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
205190|NCT01545388|P3|Participant Flow|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
205191|NCT01545388|P2|Participant Flow|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
205192|NCT01545388|P1|Participant Flow|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
205193|NCT01545388|O3|Outcome|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
205194|NCT01545388|O2|Outcome|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
205195|NCT01545388|O1|Outcome|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
205196|NCT01545388|O3|Outcome|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
205197|NCT01545388|O2|Outcome|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
205198|NCT01545388|O1|Outcome|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
205199|NCT01545388|O3|Outcome|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
205200|NCT01545388|O2|Outcome|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
205201|NCT01545388|O1|Outcome|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
205202|NCT01545388|O3|Outcome|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
205203|NCT01545388|O2|Outcome|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
205204|NCT01545388|O1|Outcome|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
205205|NCT01545388|E3|Reported Event|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
205206|NCT01545388|E2|Reported Event|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
205207|NCT01545388|E1|Reported Event|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
205208|NCT01545375|B3|Baseline|Total|Total of all reporting groups
205209|NCT01545375|B2|Baseline|Control Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205210|NCT01545375|B1|Baseline|dPly-PhtD Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205211|NCT01545375|P2|Participant Flow|Control Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
206227|NCT01541969|E1|Reported Event|Acoustic CR Neuromodulation|see Protocol section for details
205212|NCT01545375|P1|Participant Flow|dPly-PhtD Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205213|NCT01545375|O2|Outcome|Control Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205214|NCT01545375|O1|Outcome|dPly-PhtD Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205215|NCT01545375|O2|Outcome|Control Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205216|NCT01545375|O1|Outcome|dPly-PhtD Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205217|NCT01545375|O2|Outcome|Control Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205218|NCT01545375|O1|Outcome|dPly-PhtD Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205275|NCT01545232|P2|Participant Flow|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
205412|NCT01544478|B1|Baseline|V501|Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6
206228|NCT01541930|B1|Baseline|GK567|Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g
205219|NCT01545375|O2|Outcome|Control Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205220|NCT01545375|O1|Outcome|dPly-PhtD Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205221|NCT01545375|O2|Outcome|Control Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205222|NCT01545375|O1|Outcome|dPly-PhtD Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205223|NCT01545375|O2|Outcome|Control Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205224|NCT01545375|O1|Outcome|dPly-PhtD Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205225|NCT01545375|O2|Outcome|Control Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205276|NCT01545232|P1|Participant Flow|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
205317|NCT01545193|E1|Reported Event|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
205226|NCT01545375|O1|Outcome|dPly-PhtD Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205227|NCT01545375|O2|Outcome|Control Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205228|NCT01545375|O1|Outcome|dPly-PhtD Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205229|NCT01545375|O2|Outcome|Control Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205230|NCT01545375|O1|Outcome|dPly-PhtD Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205231|NCT01545375|O2|Outcome|Control Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205232|NCT01545375|O1|Outcome|dPly-PhtD Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205277|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
205318|NCT01544998|B1|Baseline|Entire Study Population|Includes groups randomized to receive Tadalafil plus Nesiritide first, and Tadalafil plus Placebo first.
206721|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
205233|NCT01545375|O2|Outcome|Control Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205234|NCT01545375|O1|Outcome|dPly-PhtD Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205235|NCT01545375|O2|Outcome|Control Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205236|NCT01545375|O1|Outcome|dPly-PhtD Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205237|NCT01545375|O2|Outcome|Control Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205238|NCT01545375|O1|Outcome|dPly-PhtD Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205239|NCT01545375|O2|Outcome|Control Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205278|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
205352|NCT01544582|P4|Participant Flow|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
205353|NCT01544582|P3|Participant Flow|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
205240|NCT01545375|O1|Outcome|dPly-PhtD Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205241|NCT01545375|O2|Outcome|Control Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205242|NCT01545375|O1|Outcome|dPly-PhtD Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205243|NCT01545375|O2|Outcome|Control Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205244|NCT01545375|O1|Outcome|dPly-PhtD Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205245|NCT01545375|O2|Outcome|Control Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205246|NCT01545375|O1|Outcome|dPly-PhtD Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205279|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
205354|NCT01544582|P2|Participant Flow|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
206722|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
205247|NCT01545375|O2|Outcome|Control Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205248|NCT01545375|O1|Outcome|dPly-PhtD Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205249|NCT01545375|O2|Outcome|Control Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205250|NCT01545375|O1|Outcome|dPly-PhtD Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205251|NCT01545375|O2|Outcome|Control Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205252|NCT01545375|O1|Outcome|dPly-PhtD Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205253|NCT01545375|O2|Outcome|Control Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205280|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
205355|NCT01544582|P1|Participant Flow|All Included Participants|All CHC genotype-1 participants included in study.
205413|NCT01544478|P1|Participant Flow|V501|Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6
205254|NCT01545375|O1|Outcome|dPly-PhtD Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205255|NCT01545375|O2|Outcome|Control Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205256|NCT01545375|O1|Outcome|dPly-PhtD Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205257|NCT01545375|E2|Reported Event|Control Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205258|NCT01545375|E1|Reported Event|dPly/PhtD Group|"Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.~PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.~At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.~At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate."
205259|NCT01545336|B3|Baseline|Total|Total of all reporting groups
205260|NCT01545336|B2|Baseline|Placebo|Placebo 1 mg tablet by mouth once daily for 3 months
205261|NCT01545336|B1|Baseline|Anastrozole|Anastrozole 1 mg tablet by mouth once daily for 3 months
205262|NCT01545336|P2|Participant Flow|Placebo|Placebo 1 mg tablet by mouth once daily for 3 months
205263|NCT01545336|P1|Participant Flow|Anastrozole|Anastrozole 1 mg tablet by mouth once daily for 3 months
205264|NCT01545336|O2|Outcome|Placebo|Placebo 1 mg tablet by mouth once daily for 3 months
205265|NCT01545336|O1|Outcome|Anastrozole|Anastrozole 1 mg tablet by mouth once daily for 3 months
205266|NCT01545336|O2|Outcome|Placebo|Placebo 1 mg tablet by mouth once daily for 3 months
205267|NCT01545336|O1|Outcome|Anastrozole|Anastrozole 1 mg tablet by mouth once daily for 3 months
205268|NCT01545336|O2|Outcome|Placebo|"Placebo tablet by mouth once daily for 3 months~Placebo: 1 mg tablet to be taken 1 time daily"
205269|NCT01545336|O1|Outcome|Anastrozole|"1 mg tablet by mouth once daily for 3 months~Anastrozole: 1 mg tablet to be taken 1 time daily"
205270|NCT01545336|E2|Reported Event|Placebo|Placebo 1 mg tablet by mouth once daily for 3 months
205271|NCT01545336|E1|Reported Event|Anastrozole|Anastrozole 1 mg tablet by mouth once daily for 3 months
205272|NCT01545232|B3|Baseline|Total|Total of all reporting groups
205273|NCT01545232|B2|Baseline|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
205274|NCT01545232|B1|Baseline|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
207169|NCT01537120|O2|Outcome|Vildagliptin|Vildagliptin tablets 50 mg twice daily for 12 weeks
205281|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
205282|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
205283|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
205284|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
205285|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
205286|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
205287|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
205288|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
205289|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
205290|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
205291|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
205292|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
205293|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
205294|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
205295|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
205402|NCT01544582|O3|Outcome|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
205296|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
205297|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
205298|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
205299|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
205300|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
205301|NCT01545232|E2|Reported Event|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
205302|NCT01545232|E1|Reported Event|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
205303|NCT01545193|B3|Baseline|Total|Total of all reporting groups
205304|NCT01545193|B2|Baseline|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
205305|NCT01545193|B1|Baseline|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
205306|NCT01545193|P2|Participant Flow|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
205307|NCT01545193|P1|Participant Flow|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
205308|NCT01545193|O2|Outcome|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
205309|NCT01545193|O1|Outcome|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
205310|NCT01545193|O2|Outcome|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
205311|NCT01545193|O1|Outcome|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
205312|NCT01545193|O2|Outcome|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
205313|NCT01545193|O1|Outcome|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
205314|NCT01545193|O2|Outcome|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
205315|NCT01545193|O1|Outcome|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
205316|NCT01545193|E2|Reported Event|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
205319|NCT01544998|P2|Participant Flow|Tadalafil Plus Nesiritide, Then Tadalafil Plus Placebo|First intervention period: oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. There was a one week washout period. Second intervention period: oral Tadalafil; after 1 hour, sc placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting.
205320|NCT01544998|P1|Participant Flow|Tadalafil Plus Placebo, Then Tadalafil Plus Nesiritide|First intervention period: oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. There was a one week washout period. Second intervention period: oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting.
205321|NCT01544998|O2|Outcome|Tadalafil Plus Placebo|Oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
205322|NCT01544998|O1|Outcome|Tadalafil Plus Nesiritide|Oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
205323|NCT01544998|O2|Outcome|Tadalafil Plus Placebo|Oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
205324|NCT01544998|O1|Outcome|Tadalafil Plus Nesiritide|Oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
205325|NCT01544998|O2|Outcome|Tadalafil Plus Placebo|Oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
205326|NCT01544998|O1|Outcome|Tadalafil Plus Nesiritide|Oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
205327|NCT01544998|O2|Outcome|Tadalafil Plus Placebo|Oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
205328|NCT01544998|O1|Outcome|Tadalafil Plus Nesiritide|Oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
205329|NCT01544998|O2|Outcome|Tadalafil Plus Placebo|Oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
205330|NCT01544998|O1|Outcome|Tadalafil Plus Nesiritide|Oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
205331|NCT01544998|O2|Outcome|Tadalafil Plus Placebo|Oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
205332|NCT01544998|O1|Outcome|Tadalafil Plus Nesiritide|Oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
205403|NCT01544582|O2|Outcome|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
205333|NCT01544998|E4|Reported Event|PDD: Tadalafil Plus Placebo|Oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
205334|NCT01544998|E3|Reported Event|PDD: Tadalafil Plus Nesiritide|Oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
205335|NCT01544998|E2|Reported Event|PSD: Tadalafil Plus Placebo|Oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
205336|NCT01544998|E1|Reported Event|PSD: Tadalafil Plus Nesiritide|Oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
205337|NCT01544920|B3|Baseline|Total|Total of all reporting groups
205338|NCT01544920|B2|Baseline|Arm 2: BOC + Peg-IFN + RBV|Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].
205339|NCT01544920|B1|Baseline|Arm 1: Peg-IFN + RBV|Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].
205340|NCT01544920|P2|Participant Flow|Arm 2: BOC + Peg-IFN + RBV|Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].
205341|NCT01544920|P1|Participant Flow|Arm 1: Peg-IFN + RBV|Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].
205342|NCT01544920|O2|Outcome|Arm 2a: BOC + Peg-IFN + RBV 24 Weeks|Participants received an initial 4 week lead-in of peg-IFN + RBV. The subset of participants with undetectable HCV RNA at Week 4 received an additional 20 weeks of BOC + peg-IFN + RBV for a total of 24 weeks of BOC (added at Week 4) + peg-IFN + RBV therapy.
205343|NCT01544920|O1|Outcome|Arm 1a: Peg-IFN + RBV 24 Weeks|Participants received an initial 4 week lead-in of peg-IFN + RBV. The subset of participants with undetectable HCV RNA at Week 4 received an additional 20 weeks of peg-IFN + RBV for a total of 24 weeks of peg-IFN + RBV therapy.
205344|NCT01544920|O2|Outcome|Arm 2: BOC + Peg-IFN + RBV|Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].
205345|NCT01544920|O1|Outcome|Arm 1: Peg-IFN + RBV|Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].
205346|NCT01544920|E2|Reported Event|Arm 2: BOC + Peg-IFN + RBV|Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].
205347|NCT01544920|E1|Reported Event|Arm 1: Peg-IFN + RBV|Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].
205348|NCT01544582|B4|Baseline|Total|Total of all reporting groups
205349|NCT01544582|B3|Baseline|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
205350|NCT01544582|B2|Baseline|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
205351|NCT01544582|B1|Baseline|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
205356|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
205357|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
205358|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
205359|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
205360|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
205361|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
205362|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
205363|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
205364|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
205365|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
205366|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
205367|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
205368|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
205404|NCT01544582|O1|Outcome|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
205405|NCT01544582|O3|Outcome|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
205369|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
205370|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
205371|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
205372|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
205373|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
205374|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
205375|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
205376|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
205377|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
205378|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
205379|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
205380|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
205406|NCT01544582|O2|Outcome|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
205407|NCT01544582|O1|Outcome|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
205408|NCT01544582|O1|Outcome|All Included Participants|All CHC genotype-1 participants included in study.
205381|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
205382|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
205383|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
205384|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
205385|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
205386|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
205387|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
205388|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
205389|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
205390|NCT01544582|O3|Outcome|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
205391|NCT01544582|O2|Outcome|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
205392|NCT01544582|O1|Outcome|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
205393|NCT01544582|O3|Outcome|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
205394|NCT01544582|O2|Outcome|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
205395|NCT01544582|O1|Outcome|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
205396|NCT01544582|O3|Outcome|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
205397|NCT01544582|O2|Outcome|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
205398|NCT01544582|O1|Outcome|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
205399|NCT01544582|O3|Outcome|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
205400|NCT01544582|O2|Outcome|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
205401|NCT01544582|O1|Outcome|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
205414|NCT01544478|O1|Outcome|V501|Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6
205415|NCT01544478|E1|Reported Event|V501|Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6
205416|NCT01544361|B6|Baseline|TOTAL|Total of all reporting groups
205417|NCT01544361|B5|Baseline|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
205418|NCT01544361|B4|Baseline|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
205419|NCT01544361|B3|Baseline|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
205420|NCT01544361|B2|Baseline|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
205421|NCT01544361|B1|Baseline|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
205422|NCT01544361|P5|Participant Flow|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
205423|NCT01544361|P4|Participant Flow|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
205424|NCT01544361|P3|Participant Flow|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
205425|NCT01544361|P2|Participant Flow|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
205426|NCT01544361|P1|Participant Flow|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
205427|NCT01544361|O5|Outcome|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
205428|NCT01544361|O4|Outcome|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
205429|NCT01544361|O3|Outcome|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
205430|NCT01544361|O2|Outcome|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
205431|NCT01544361|O1|Outcome|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
205432|NCT01544361|O5|Outcome|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
205433|NCT01544361|O4|Outcome|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
205434|NCT01544361|O3|Outcome|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
205435|NCT01544361|O2|Outcome|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
205436|NCT01544361|O1|Outcome|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
205437|NCT01544361|O5|Outcome|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
205438|NCT01544361|O4|Outcome|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
205439|NCT01544361|O3|Outcome|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
205440|NCT01544361|O2|Outcome|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
205441|NCT01544361|O1|Outcome|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
205442|NCT01544361|E5|Reported Event|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
205443|NCT01544361|E4|Reported Event|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
205444|NCT01544361|E3|Reported Event|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
205445|NCT01544361|E2|Reported Event|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
205446|NCT01544361|E1|Reported Event|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
205447|NCT01544348|B9|Baseline|Total|Total of all reporting groups
205448|NCT01544348|B8|Baseline|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
205449|NCT01544348|B7|Baseline|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
205450|NCT01544348|B6|Baseline|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
205451|NCT01544348|B5|Baseline|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
205452|NCT01544348|B4|Baseline|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
205453|NCT01544348|B3|Baseline|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
205454|NCT01544348|B2|Baseline|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant’s Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
205455|NCT01544348|B1|Baseline|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
205456|NCT01544348|P8|Participant Flow|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
205457|NCT01544348|P7|Participant Flow|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
205458|NCT01544348|P6|Participant Flow|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
205459|NCT01544348|P5|Participant Flow|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
205460|NCT01544348|P4|Participant Flow|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
205461|NCT01544348|P3|Participant Flow|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
205462|NCT01544348|P2|Participant Flow|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant’s Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
205463|NCT01544348|P1|Participant Flow|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
205464|NCT01544348|O8|Outcome|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
205465|NCT01544348|O7|Outcome|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
205466|NCT01544348|O6|Outcome|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
205467|NCT01544348|O5|Outcome|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
205468|NCT01544348|O4|Outcome|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
205469|NCT01544348|O3|Outcome|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
205470|NCT01544348|O2|Outcome|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant’s Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
205471|NCT01544348|O1|Outcome|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
205472|NCT01544348|O7|Outcome|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
205473|NCT01544348|O6|Outcome|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
205474|NCT01544348|O5|Outcome|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
205475|NCT01544348|O4|Outcome|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
205476|NCT01544348|O3|Outcome|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
205477|NCT01544348|O2|Outcome|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
205478|NCT01544348|O1|Outcome|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
205479|NCT01544348|O7|Outcome|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
205480|NCT01544348|O6|Outcome|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
205481|NCT01544348|O5|Outcome|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
205482|NCT01544348|O4|Outcome|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
205483|NCT01544348|O3|Outcome|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
205484|NCT01544348|O2|Outcome|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
205485|NCT01544348|O1|Outcome|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant’s Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
205486|NCT01544348|O8|Outcome|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
205487|NCT01544348|O7|Outcome|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
205488|NCT01544348|O6|Outcome|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
205489|NCT01544348|O5|Outcome|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
205490|NCT01544348|O4|Outcome|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
205491|NCT01544348|O3|Outcome|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
205492|NCT01544348|O2|Outcome|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant’s Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
205493|NCT01544348|O1|Outcome|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
205494|NCT01544348|E8|Reported Event|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
205495|NCT01544348|E7|Reported Event|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
205496|NCT01544348|E6|Reported Event|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
205497|NCT01544348|E5|Reported Event|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
205498|NCT01544348|E4|Reported Event|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
205499|NCT01544348|E3|Reported Event|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
205500|NCT01544348|E2|Reported Event|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant’s Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
205501|NCT01544348|E1|Reported Event|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
205502|NCT01544309|B3|Baseline|Total|Total of all reporting groups
205503|NCT01544309|B2|Baseline|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
205504|NCT01544309|B1|Baseline|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
205505|NCT01544309|P2|Participant Flow|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the rosuvastatin [RSV] dose of 10 mg.)"
205506|NCT01544309|P1|Participant Flow|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in the Japan Atherosclerosis Society (JAS) Guidelines (GL) after 3 months, had the atorvastatin [ATV] dose of 20 mg.)"
205507|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
205508|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
205509|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
205510|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
205511|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
205512|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
205513|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
205514|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
205515|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
205516|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
205517|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
205518|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
205519|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
205520|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
205521|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
205522|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
205523|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
205524|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
205525|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
205526|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
205527|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
205528|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
205529|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
205530|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
205622|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
205531|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
205532|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
205533|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
205534|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
205535|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
205536|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
205537|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
205538|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
205539|NCT01544309|E2|Reported Event|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
205540|NCT01544309|E1|Reported Event|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
205541|NCT01544179|B3|Baseline|Total|Total of all reporting groups
205542|NCT01544179|B2|Baseline|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
205543|NCT01544179|B1|Baseline|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
205544|NCT01544179|P2|Participant Flow|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
205545|NCT01544179|P1|Participant Flow|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
205546|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
205547|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
205548|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
205549|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
205550|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
205551|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
205552|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
205553|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
205554|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
205555|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
205556|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
205557|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
205558|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
205559|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
205560|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
205561|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
205562|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
205563|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
205564|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
205565|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
205566|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
205567|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
205568|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
205569|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
205570|NCT01544179|E2|Reported Event|Placebo|
205571|NCT01544179|E1|Reported Event|Gefitinib 250 mg|
205572|NCT01544166|B1|Baseline|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
205573|NCT01544166|P1|Participant Flow|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
205574|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
205575|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
205576|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
205577|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
205578|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
205579|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
205580|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
205581|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
205582|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
205583|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
205584|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
205585|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
205586|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
205587|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
205588|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
205589|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
205590|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
205591|NCT01544166|O1|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
205592|NCT01544166|O1|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
205593|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
205594|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
205595|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
205596|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
205597|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
205598|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
205599|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
205600|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
205601|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
205602|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
205603|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
205604|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
205605|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
205606|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
205607|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
205608|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
205609|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
205610|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
205611|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
205612|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
205613|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
205614|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
205615|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
205616|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
205617|NCT01544166|O1|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
205618|NCT01544166|O1|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
205619|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
205620|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
205621|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
205623|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
205624|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
205625|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
205626|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
205627|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
205628|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
205629|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
205630|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
205631|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
205632|NCT01544166|E1|Reported Event|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
205633|NCT01544153|B5|Baseline|Total|Total of all reporting groups
205634|NCT01544153|B4|Baseline|WEB+SN+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
205635|NCT01544153|B3|Baseline|WEB+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
205636|NCT01544153|B2|Baseline|WEB+SN|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org."
205637|NCT01544153|B1|Baseline|WEB Only|"Control group receiving no additional intervention~WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website."
205638|NCT01544153|P4|Participant Flow|WEB+SN+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
205639|NCT01544153|P3|Participant Flow|WEB+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
205640|NCT01544153|P2|Participant Flow|WEB+SN|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org."
205641|NCT01544153|P1|Participant Flow|WEB Only|"Control group receiving no additional intervention~WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website."
205642|NCT01544153|O4|Outcome|WEB+SN+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
205643|NCT01544153|O3|Outcome|WEB+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
205644|NCT01544153|O2|Outcome|WEB+SN|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org."
205645|NCT01544153|O1|Outcome|WEB Only|"Control group receiving no additional intervention~WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website."
205646|NCT01544153|O4|Outcome|WEB+SN+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
207170|NCT01537120|O1|Outcome|Placebo|Placebo tablets twice daily for 3 weeks
205647|NCT01544153|O3|Outcome|WEB+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
205648|NCT01544153|O2|Outcome|WEB+SN|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org."
205649|NCT01544153|O1|Outcome|WEB Only|"Control group receiving no additional intervention~WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website."
205650|NCT01544153|E4|Reported Event|WEB+SN+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
205651|NCT01544153|E3|Reported Event|WEB+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
205652|NCT01544153|E2|Reported Event|WEB+SN|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org."
205653|NCT01544153|E1|Reported Event|WEB Only|"Control group receiving no additional intervention~WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website."
205654|NCT01544114|B4|Baseline|Total|Total of all reporting groups
205655|NCT01544114|B3|Baseline|VIMOVO 500 mg/20 mg|500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205656|NCT01544114|B2|Baseline|VIMOVO 375 mg/20 mg|375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205657|NCT01544114|B1|Baseline|VIMOVO 250 mg/20 mg|250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205658|NCT01544114|P3|Participant Flow|VIMOVO 500 mg/20 mg|500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205659|NCT01544114|P2|Participant Flow|VIMOVO 375 mg/20 mg|375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205660|NCT01544114|P1|Participant Flow|VIMOVO 250 mg/20 mg|250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205661|NCT01544114|O3|Outcome|VIMOVO 500 mg/20 mg|500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205662|NCT01544114|O2|Outcome|VIMOVO 375 mg/20 mg|375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205663|NCT01544114|O1|Outcome|VIMOVO 250 mg/20 mg|250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205664|NCT01544114|O4|Outcome|Total|250 mg naproxen/20 mg esomeprazole magnesium, 375 mg naproxen/20 mg esomeprazole magnesium, or 500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205665|NCT01544114|O3|Outcome|VIMOVO 500 mg/20 mg|500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205666|NCT01544114|O2|Outcome|VIMOVO 375 mg/20 mg|375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205667|NCT01544114|O1|Outcome|VIMOVO 250 mg/20 mg|250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205668|NCT01544114|O4|Outcome|Total|250 mg naproxen/20 mg esomeprazole magnesium, 375 mg naproxen/20 mg esomeprazole magnesium, or 500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205669|NCT01544114|O3|Outcome|VIMOVO 500 mg/20 mg|500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205670|NCT01544114|O2|Outcome|VIMOVO 375 mg/20 mg|375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205671|NCT01544114|O1|Outcome|VIMOVO 250 mg/20 mg|250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205672|NCT01544114|O4|Outcome|Total|250 mg naproxen/20 mg esomeprazole magnesium, 375 mg naproxen/20 mg esomeprazole magnesium, or 500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205673|NCT01544114|O3|Outcome|VIMOVO 500 mg/20 mg|500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205674|NCT01544114|O2|Outcome|VIMOVO 375 mg/20 mg|375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205675|NCT01544114|O1|Outcome|VIMOVO 250 mg/20 mg|250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205676|NCT01544114|O4|Outcome|Total|250 mg naproxen/20 mg esomeprazole magnesium, 375 mg naproxen/20 mg esomeprazole magnesium, or 500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205677|NCT01544114|O3|Outcome|VIMOVO 500 mg/20 mg|500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205678|NCT01544114|O2|Outcome|VIMOVO 375 mg/20 mg|375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205679|NCT01544114|O1|Outcome|VIMOVO 250 mg/20 mg|250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205757|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205680|NCT01544114|O4|Outcome|Total|250 mg naproxen/20 mg esomeprazole magnesium, 375 mg naproxen/20 mg esomeprazole magnesium, or 500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205681|NCT01544114|O3|Outcome|VIMOVO 500 mg/20 mg|500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205682|NCT01544114|O2|Outcome|VIMOVO 375 mg/20 mg|375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205683|NCT01544114|O1|Outcome|VIMOVO 250 mg/20 mg|250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205684|NCT01544114|E4|Reported Event|Total|250 mg naproxen/20 mg esomeprazole magnesium, 375 mg naproxen/20 mg esomeprazole magnesium, or 500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205685|NCT01544114|E3|Reported Event|VIMOVO 500 mg/20 mg|500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205686|NCT01544114|E2|Reported Event|VIMOVO 375 mg/20 mg|375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205687|NCT01544114|E1|Reported Event|VIMOVO 250 mg/20 mg|250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
205688|NCT01544062|B3|Baseline|Total|Total of all reporting groups
205689|NCT01544062|B2|Baseline|Normal Saline|Study subjects receiving placebo
205690|NCT01544062|B1|Baseline|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205691|NCT01544062|P2|Participant Flow|Normal Saline|Study subjects receiving placebo
205692|NCT01544062|P1|Participant Flow|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205693|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205694|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205695|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205696|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205697|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205698|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205699|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205700|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205701|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205702|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205703|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205704|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205758|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205759|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205705|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205706|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205707|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205708|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205709|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205710|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205711|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205712|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205713|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205714|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205715|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205716|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205717|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205718|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205719|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205720|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205721|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205722|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205723|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205724|NCT01544062|O1|Outcome|Normal Saline|Study subjects receiving placebo
205760|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205725|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205726|NCT01544062|O1|Outcome|Normal Saline|Study subjects receiving placebo
205727|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205728|NCT01544062|O1|Outcome|Normal Saline|Study subjects receiving placebo
205729|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205730|NCT01544062|O1|Outcome|Normal Saline|Study subjects receiving placebo
205731|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205732|NCT01544062|O1|Outcome|Normal Saline|Study subjects receiving placebo
205733|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205734|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205735|NCT01544062|E2|Reported Event|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205736|NCT01544062|E1|Reported Event|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
205737|NCT01544023|B1|Baseline|TiLOOP|"Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP Bra (pfm medical, Cologne, Germany) were included."
205738|NCT01544023|P1|Participant Flow|TiLOOP|"Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP Bra (pfm medical, Cologne, Germany) were included."
205739|NCT01544023|O1|Outcome|TiLOOP|"Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP Bra (pfm medical, Cologne, Germany) were included."
205740|NCT01544023|O1|Outcome|TiLOOP|"Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP Bra (pfm medical, Cologne, Germany) were included."
205741|NCT01544023|E1|Reported Event|TiLOOP|"Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP Bra (pfm medical, Cologne, Germany) were included."
205742|NCT01543958|B1|Baseline|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205743|NCT01543958|P1|Participant Flow|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205744|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205745|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205746|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205747|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205748|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205749|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205750|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205751|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205752|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205753|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205754|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205755|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205756|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205761|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205762|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205763|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205764|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205765|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205766|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205767|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205768|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205769|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205770|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205771|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205772|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205773|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205774|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205775|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205776|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205777|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205778|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205779|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205780|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205781|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205782|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205783|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205784|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205785|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205786|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205787|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205788|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205789|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205790|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205791|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205792|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205793|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205794|NCT01543958|E1|Reported Event|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
205795|NCT01543828|B3|Baseline|Total|Total of all reporting groups
205796|NCT01543828|B2|Baseline|Placebo Then Indacaterol|In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.
205797|NCT01543828|B1|Baseline|Indacaterol Then Placebo|In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.
205798|NCT01543828|P2|Participant Flow|Placebo Then Indacaterol|In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.
205799|NCT01543828|P1|Participant Flow|Indacaterol Then Placebo|In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.
205800|NCT01543828|O4|Outcome|placebo_treatment 2|In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.
205801|NCT01543828|O3|Outcome|placebo_treatment 1|In treatment 1, participants received placebo one dose delivered via SDDPI. Albuterol was available for use as rescue medication.
205802|NCT01543828|O2|Outcome|indacaterol_treatment 2|In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.
205803|NCT01543828|O1|Outcome|indacaterol_treatment 1|In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI). Albuterol was available for use as rescue medication.
205804|NCT01543828|E2|Reported Event|Placebo|Participants received placebo one dose delivered via SDDPI.
205805|NCT01543828|E1|Reported Event|Indacaterol|Participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI).
205806|NCT01543685|B6|Baseline|Total|Total of all reporting groups
205807|NCT01543685|B5|Baseline|Placebo|Placebo : Capsules
205808|NCT01543685|B4|Baseline|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
205809|NCT01543685|B3|Baseline|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
205810|NCT01543685|B2|Baseline|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
205811|NCT01543685|B1|Baseline|Celecoxib 200 mg|Celecoxib : 200 mg capsules
205812|NCT01543685|P5|Participant Flow|Placebo|Placebo : Capsules
205813|NCT01543685|P4|Participant Flow|Celecoxib 200 mg|Celecoxib : 200 mg capsules
205814|NCT01543685|P3|Participant Flow|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
205815|NCT01543685|P2|Participant Flow|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
205816|NCT01543685|P1|Participant Flow|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
205817|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
205818|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
205819|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
205820|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
205821|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
205822|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
205823|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
205824|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
205825|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
205826|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
205827|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
205828|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
205829|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
205830|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
205831|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
205832|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
205833|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
205834|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
205835|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
205836|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
205837|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
205838|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
205839|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
205840|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
205841|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
205842|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
205843|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
205844|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
205845|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
205846|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
205847|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
205848|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
205849|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
205850|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
205851|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
205852|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
205853|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
205854|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
205855|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
205856|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
205857|NCT01543685|E5|Reported Event|Placebo|Placebo : Capsules
205858|NCT01543685|E4|Reported Event|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
205859|NCT01543685|E3|Reported Event|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
205860|NCT01543685|E2|Reported Event|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
205861|NCT01543685|E1|Reported Event|Celecoxib 200 mg|Celecoxib : 200 mg capsules
205862|NCT01543607|B1|Baseline|Treatment|"Radiofrequency ablation catheter~Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct"
205863|NCT01543607|P1|Participant Flow|Treatment|"Radiofrequency ablation catheter~Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct"
205864|NCT01543607|O1|Outcome|Treatment|"Radiofrequency ablation catheter~Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct"
205865|NCT01543607|O1|Outcome|Treatment|"Radiofrequency ablation catheter~Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct"
205866|NCT01543607|O1|Outcome|Treatment|"Radiofrequency ablation catheter~Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct"
205867|NCT01543607|E1|Reported Event|Treatment|"Radiofrequency ablation catheter~Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct"
205868|NCT01543581|B1|Baseline|Vismodegib|Oral vismodegib, 150mg per day for 12 weeks.
205869|NCT01543581|P2|Participant Flow|Inactive Placebo|Those to whom the inactive placebo is given.
205870|NCT01543581|P1|Participant Flow|Vismodegib|Those to whom the drug is given.
205871|NCT01543581|O1|Outcome|Vismodegib|Those to whom the drug is given.
205872|NCT01543581|O1|Outcome|Vismodegib|Oral vismodegib, 150mg per day for 12 weeks.
205873|NCT01543581|E2|Reported Event|Inactive Placebo|Those to whom the inactive placebo is given.
205874|NCT01543581|E1|Reported Event|Vismodegib|Oral vismodegib, 150mg per day for 12 weeks.
205875|NCT01543568|B1|Baseline|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
205876|NCT01543568|P1|Participant Flow|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
205877|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
205878|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
205879|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
205880|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
205881|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
205882|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
205883|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
205884|NCT01543568|E1|Reported Event|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
205885|NCT01543503|B3|Baseline|Total|Total of all reporting groups
205886|NCT01543503|B2|Baseline|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205887|NCT01543503|B1|Baseline|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205888|NCT01543503|P2|Participant Flow|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205889|NCT01543503|P1|Participant Flow|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205956|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
206229|NCT01541930|P1|Participant Flow|GK567|Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g
205890|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205891|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205892|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205893|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205894|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205895|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205896|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205897|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205898|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205899|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205900|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205901|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205902|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205903|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205904|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205905|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205906|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205907|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205908|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205909|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205910|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205911|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205912|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205913|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205914|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205915|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205916|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205917|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205918|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205919|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205920|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205921|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205922|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205923|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205924|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205925|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205926|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205927|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205928|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205929|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205930|NCT01543503|E2|Reported Event|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205931|NCT01543503|E1|Reported Event|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
205932|NCT01543204|B1|Baseline|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
205933|NCT01543204|P1|Participant Flow|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
205934|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
205935|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
205936|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
205937|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
205938|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
205939|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
205940|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
205941|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
205942|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
205943|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
205944|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
205945|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
205946|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
205947|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
205948|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
205949|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..
205950|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
205951|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
205952|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..
205953|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
205954|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
205955|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..
206232|NCT01541930|O1|Outcome|GK567, Day 0|Metronidazole Gel 0.75%, Pain evaluation on Day 0 (baseline) by Visual Analogue Scale (mm)
205957|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
205958|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..
205959|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
205960|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
205961|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..
205962|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
205963|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
205964|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
205965|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
205966|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
205967|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..
205968|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
205969|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
205970|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
205971|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
205972|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
205973|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
205974|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
205975|NCT01543204|E1|Reported Event|Etanercept 50mg BIW/50mg QW|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
205976|NCT01543178|B4|Baseline|Total|Total of all reporting groups
205977|NCT01543178|B3|Baseline|Double-blind Placebo (Retreatment)|The 308 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the placebo group for the double-blind retreatment period.
205978|NCT01543178|B2|Baseline|Double-blind Rifaximin (Retreatment)|The 328 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the rifaximin group for the double-blind retreatment period.
205979|NCT01543178|B1|Baseline|Open-label Rifaximin Only|The 1943 subjects in this group did not continue into the double-blind period of the study. Open-label treatment was rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up.
205980|NCT01543178|P3|Participant Flow|Double-blind Placebo (Retreatment)|The 308 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the placebo group for the double-blind retreatment period. For participant flow during the open-label period, these subjects are included in the 2583 subjects in the open-label rifaximin group.
205981|NCT01543178|P2|Participant Flow|Double-blind Rifaximin (Retreatment)|The 328 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the rifaximin group for the double-blind retreatment period. For participant flow during the open-label period, these subjects are included in the 2583 subjects in the open-label rifaximin group.
205982|NCT01543178|P1|Participant Flow|Open-label Rifaximin|"Subjects received open-label rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up. Responders continued into Maintenance Phase 1 (treatment free). Nonresponders withdrew from the study.~Of the 2583 subjects in this group, 636 eventually met criteria for recurrence in Maintenance Phase 1, entered the double-blind period, and were randomized 1:1 to receive rifaximin 550 mg or placebo."
205983|NCT01543178|O2|Outcome|Double-blind Placebo (Retreatment)|"The 308 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the placebo group for the double-blind retreatment period.~During the double-blind period, subjects in this arm received placebo TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks [treatment free]) followed by a second retreatment with placebo."
206230|NCT01541930|O3|Outcome|GK567, Day 14|Metronidazole Gel 0.75%, Pain evaluation on Day 14 by Visual Analogue Scale (mm) One patient was withdrawn on Day 7 by Subject's request
205984|NCT01543178|O1|Outcome|Double-blind Rifaximin (Retreatment)|"The 328 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the rifaximin group for the double-blind retreatment period.~During the double-blind period, subjects in this arm received rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks [treatment free]) followed by a second retreatment with rifaximin."
205985|NCT01543178|E3|Reported Event|Double-blind Retreatment Experience - Placebo Group|"The 308 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the placebo group for the double-blind retreatment period.~During the double-blind period, subjects in this arm received placebo TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks [treatment free]) followed by a second retreatment with placebo.~Double-blind experience is shown here."
205986|NCT01543178|E2|Reported Event|Double-blind Retreatment Experience - Rifaximin Group|"The 328 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the rifaximin group for the double-blind retreatment period.~During the double-blind period, subjects in this arm received rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks [treatment free]) followed by a second retreatment with rifaximin.~Double-blind experience is shown here."
205987|NCT01543178|E1|Reported Event|Total Open-label Experience|"This group includes all 2579 subjects who received rifaximin the open-label period.~Open-label experience is shown here."
205988|NCT01543074|B5|Baseline|Total|Total of all reporting groups
205989|NCT01543074|B4|Baseline|BSE & Garlic Oil|"two BSE and one garlic oil capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE plus garlic oil placebo: see arm description"
205990|NCT01543074|B3|Baseline|BSE Plus Garlic Oil Placebo|"two BSE capsules plus one garlic oil placebo capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE & Garlic Oil: see arm description"
205991|NCT01543074|B2|Baseline|Garlic Oil Plus BSE Placebo|"one garlic oil capsule plus 2 BSE placebo capsules per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE plus garlic oil placebo: see arm description"
205992|NCT01543074|B1|Baseline|BSE Placebo & Garlic Oil Placebo|"Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE & Garlic Oil: see arm description"
205993|NCT01543074|P4|Participant Flow|BSE & Garlic Oil|"two BSE and one garlic oil capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE plus garlic oil placebo: see arm description"
205994|NCT01543074|P3|Participant Flow|BSE Plus Garlic Oil Placebo|"two BSE capsules plus one garlic oil placebo capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE & Garlic Oil: see arm description"
205995|NCT01543074|P2|Participant Flow|Garlic Oil Plus BSE Placebo|"one garlic oil capsule plus 2 BSE placebo capsules per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE plus garlic oil placebo: see arm description"
205996|NCT01543074|P1|Participant Flow|BSE Placebo & Garlic Oil Placebo|"Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE & Garlic Oil: see arm description"
205997|NCT01543074|O4|Outcome|BSE & Garlic Oil|"two BSE and one garlic oil capsule per day for seven days~Garlic oil: 1 pill = 30 mg garlic oil/day~BSE: 2 pills = 200 micromoles of Sulforaphane/day"
205998|NCT01543074|O3|Outcome|BSE Plus Garlic Oil Placebo|"two BSE capsules plus one garlic oil placebo capsule per day for seven days~BSE: 2 pills = 200 micromoles of Sulforaphane/day~Garlic Oil Placebo: 1 pill = 0 mg garlic oil/day"
205999|NCT01543074|O2|Outcome|Garlic Oil Plus BSE Placebo|"one garlic oil capsule plus 2 BSE placebo capsules per day for seven days~BSE placebo: 2 pills = 0 micromoles of Sulforaphane/day~Garlic oil: 1 pill = 30 mg garlic oil/day"
206000|NCT01543074|O1|Outcome|BSE Placebo & Garlic Oil Placebo|"Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days~BSE placebo: 2 pills = 0 micromoles of Sulforaphane/day~Garlic Oil Placebo: 1 pill = 0 mg garlic oil/day"
206001|NCT01543074|O4|Outcome|BSE & Garlic Oil|"two BSE and one garlic oil capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE plus garlic oil placebo: see arm description"
206002|NCT01543074|O3|Outcome|BSE Plus Garlic Oil Placebo|"two BSE capsules plus one garlic oil placebo capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE & Garlic Oil: see arm description"
206003|NCT01543074|O2|Outcome|Garlic Oil Plus BSE Placebo|"one garlic oil capsule plus 2 BSE placebo capsules per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE plus garlic oil placebo: see arm description"
206004|NCT01543074|O1|Outcome|BSE Placebo & Garlic Oil Placebo|"Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE & Garlic Oil: see arm description"
206005|NCT01543074|E4|Reported Event|BSE & Garlic Oil|"two BSE and one garlic oil capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE plus garlic oil placebo: see arm description"
206006|NCT01543074|E3|Reported Event|BSE Plus Garlic Oil Placebo|"two BSE capsules plus one garlic oil placebo capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE & Garlic Oil: see arm description"
206007|NCT01543074|E2|Reported Event|Garlic Oil Plus BSE Placebo|"one garlic oil capsule plus 2 BSE placebo capsules per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE plus garlic oil placebo: see arm description"
206008|NCT01543074|E1|Reported Event|BSE Placebo & Garlic Oil Placebo|"Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE & Garlic Oil: see arm description"
206009|NCT01542957|B3|Baseline|Total|Total of all reporting groups
206010|NCT01542957|B2|Baseline|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy~Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
206036|NCT01542788|O1|Outcome|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
206011|NCT01542957|B1|Baseline|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention~Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
206012|NCT01542957|P2|Participant Flow|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy~Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
206013|NCT01542957|P1|Participant Flow|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention~Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
206014|NCT01542957|O2|Outcome|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy~Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
206015|NCT01542957|O1|Outcome|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention~Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
206016|NCT01542957|O2|Outcome|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy~Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
206017|NCT01542957|O1|Outcome|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention~Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
206018|NCT01542957|O2|Outcome|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy~Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
206019|NCT01542957|O1|Outcome|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention~Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
206020|NCT01542957|E2|Reported Event|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy~Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
206021|NCT01542957|E1|Reported Event|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention~Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
206022|NCT01542788|B3|Baseline|Total|Total of all reporting groups
206023|NCT01542788|B2|Baseline|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
206024|NCT01542788|B1|Baseline|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
206025|NCT01542788|P2|Participant Flow|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
206026|NCT01542788|P1|Participant Flow|SOF+RBV|Participants were randomized to receive sofosbuvir (SOF)+ribavirin (RBV) for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
206027|NCT01542788|O2|Outcome|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
206028|NCT01542788|O1|Outcome|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
206029|NCT01542788|O2|Outcome|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
206030|NCT01542788|O1|Outcome|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
206031|NCT01542788|O2|Outcome|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
206032|NCT01542788|O1|Outcome|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
206033|NCT01542788|O2|Outcome|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
206034|NCT01542788|O1|Outcome|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
206035|NCT01542788|O2|Outcome|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
206037|NCT01542788|O2|Outcome|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
206038|NCT01542788|O1|Outcome|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
206039|NCT01542788|E2|Reported Event|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
206040|NCT01542788|E1|Reported Event|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
206041|NCT01542684|B1|Baseline|Azacytidine + GM-CSF|"Azacytidine administered intravenously (IV) or subcutaneously (SQ) at starting dose of 40 mg/m^2, daily for 4 days.~GM-CSF administered IV or subcutaneously at 250 mcg/m^2 one day (the next day) after completion of azacytidine treatment, for 3 consecutive days.~Each treatment cycle lasts at least 4 weeks."
206042|NCT01542684|P1|Participant Flow|Azacytidine + GM-CSF|"Azacytidine administered intravenously (IV) or subcutaneously (SQ) at starting dose of 40 mg/m^2, daily for 4 days.~Granulocyte-macrophage colony-stimulating factor (GM-CSF) administered IV or subcutaneously at 250 mcg/m^2 one day (the next day) after completion of azacytidine treatment, for 3 consecutive days.~Each treatment cycle lasts at least 4 weeks."
206043|NCT01542684|O1|Outcome|Azacytidine + GM-CSF|"Azacytidine administered intravenously (IV) or subcutaneously (SQ) at starting dose of 40 mg/m^2, daily for 4 days.~GM-CSF administered IV or subcutaneously at 250 mcg/m^2 one day (the next day) after completion of azacytidine treatment, for 3 consecutive days.~Each treatment cycle will last at least 4 weeks~Azacytidine: Starting dose: 40 mg/m^2 intravenously (IV) or subcutaneously (SQ) daily for 4 days.~GM-CSF: 250 mcg/m^2 IV or SQ one day (the next day) after completion of azacytidine treatment, for 3 consecutive days."
206044|NCT01542684|E1|Reported Event|Azacytidine + GM-CSF|"Azacytidine administered intravenously (IV) or subcutaneously (SQ) at starting dose of 40 mg/m^2, daily for 4 days.~GM-CSF administered IV or subcutaneously at 250 mcg/m^2 one day (the next day) after completion of azacytidine treatment, for 3 consecutive days.~Each treatment cycle lasts at least 4 weeks."
206045|NCT01542645|B3|Baseline|Total|Total of all reporting groups
206046|NCT01542645|B2|Baseline|Fentanyl|Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
206047|NCT01542645|B1|Baseline|Methadone|Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
206048|NCT01542645|P2|Participant Flow|Fentanyl|Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
206049|NCT01542645|P1|Participant Flow|Methadone|Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
206050|NCT01542645|O2|Outcome|Fentanyl|
206051|NCT01542645|O1|Outcome|Methadone|
206052|NCT01542645|O2|Outcome|Fentanyl|Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
206053|NCT01542645|O1|Outcome|Methadone|Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
206054|NCT01542645|O2|Outcome|Fentanyl|Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
206055|NCT01542645|O1|Outcome|Methadone|Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
206056|NCT01542645|E2|Reported Event|Fentanyl|Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
206057|NCT01542645|E1|Reported Event|Methadone|Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
206058|NCT01542632|B7|Baseline|Total|Total of all reporting groups
206059|NCT01542632|B6|Baseline|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
206060|NCT01542632|B5|Baseline|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
206061|NCT01542632|B4|Baseline|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation(TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
206062|NCT01542632|B3|Baseline|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
206063|NCT01542632|B2|Baseline|Group 2 (DO:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
206064|NCT01542632|B1|Baseline|Group 1 (D0:TDV,P D90:TDV)|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
206065|NCT01542632|P6|Participant Flow|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
206066|NCT01542632|P5|Participant Flow|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
206067|NCT01542632|P4|Participant Flow|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation(TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
206068|NCT01542632|P3|Participant Flow|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
206069|NCT01542632|P2|Participant Flow|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
206070|NCT01542632|P1|Participant Flow|Group 1 (D0:TDV,P D90:TDV)|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
206071|NCT01542632|O6|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
206072|NCT01542632|O5|Outcome|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
206073|NCT01542632|O4|Outcome|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
206074|NCT01542632|O3|Outcome|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
206075|NCT01542632|O2|Outcome|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
206076|NCT01542632|O1|Outcome|Group 1 (D0:TDV,P D90:TDV)|Takedas Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
206077|NCT01542632|O6|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
206078|NCT01542632|O5|Outcome|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
206079|NCT01542632|O4|Outcome|Group 4 (D0:TDV,P D90:TDV,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
206080|NCT01542632|O3|Outcome|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
206081|NCT01542632|O2|Outcome|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
206082|NCT01542632|O1|Outcome|Group 1 (D0:TDV,P D90:TDV)|Takedas Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
206083|NCT01542632|O6|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
206084|NCT01542632|O5|Outcome|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
206085|NCT01542632|O4|Outcome|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
206086|NCT01542632|O3|Outcome|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
206087|NCT01542632|O2|Outcome|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
206088|NCT01542632|O1|Outcome|Group 1 (D0:TDV,P D90:TDV)|Takedas Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
206089|NCT01542632|O6|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
206090|NCT01542632|O5|Outcome|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
206091|NCT01542632|O4|Outcome|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
206092|NCT01542632|O3|Outcome|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
206093|NCT01542632|O2|Outcome|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
206094|NCT01542632|O1|Outcome|Group 1 (D0:TDV,P D90:TDV)|Takedas Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
206095|NCT01542632|O6|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
206096|NCT01542632|O5|Outcome|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
206097|NCT01542632|O4|Outcome|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
206098|NCT01542632|O3|Outcome|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
207171|NCT01537120|O2|Outcome|Vildagliptin|Vildagliptin tablets 50 mg twice daily for 12 weeks
206099|NCT01542632|O2|Outcome|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
206100|NCT01542632|O1|Outcome|Group 1 (D0:TDV,P D90:TDV)|Takedas Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
206101|NCT01542632|O6|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 1 and 90.
206102|NCT01542632|O5|Outcome|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
206103|NCT01542632|O4|Outcome|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
206104|NCT01542632|O3|Outcome|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 1. TDV, 0.5 mL, subcutaneous injection on Day 90.
206105|NCT01542632|O2|Outcome|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
206106|NCT01542632|O1|Outcome|Group 1 (D0:TDV,P D90:TDV)|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
206107|NCT01542632|E6|Reported Event|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
206108|NCT01542632|E5|Reported Event|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
206109|NCT01542632|E4|Reported Event|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
206110|NCT01542632|E3|Reported Event|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
206111|NCT01542632|E2|Reported Event|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
206112|NCT01542632|E1|Reported Event|Group 1 (D0:TDV,P D90:TDV)|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
206113|NCT01542541|B3|Baseline|Total|Total of all reporting groups
206114|NCT01542541|B2|Baseline|Control|Randomly-selected matched PET-CT scans performed on same day as intervention group.
206115|NCT01542541|B1|Baseline|Rifaximin|Rifaximin: 550mg BID for 2 days
206116|NCT01542541|P2|Participant Flow|Control|Randomly-selected matched PET-CT scans performed on same day as intervention group.
206117|NCT01542541|P1|Participant Flow|Rifaximin|Rifaximin: 550mg BID for 2 days
206118|NCT01542541|O2|Outcome|Control|Randomly-selected matched PET-CT scans performed on same day as intervention group.
206119|NCT01542541|O1|Outcome|Rifaximin|Rifaximin: 550mg BID for 2 days
206120|NCT01542541|O2|Outcome|Control|Randomly-selected matched PET-CT scans performed on same day as intervention group.
206121|NCT01542541|O1|Outcome|Rifaximin|Rifaximin: 550mg BID for 2 days
206122|NCT01542541|E2|Reported Event|Control|Randomly-selected matched PET-CT scans performed on same day as intervention group.
206123|NCT01542541|E1|Reported Event|Rifaximin|Rifaximin: 550mg BID for 2 days
206124|NCT01542528|B3|Baseline|Total|Total of all reporting groups
206125|NCT01542528|B2|Baseline|Treatment as Usual (TAU)|Whatever care arrangement the parents have arranged for their child during the same two hour period over the same 15 week period.
206126|NCT01542528|B1|Baseline|IBBS|"Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions).~IBBS: Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions)."
206127|NCT01542528|P2|Participant Flow|Treatment as Usual (TAU)|Whatever care arrangement the parents have arranged for their child during the same two hour period over the same 15 week period.
206128|NCT01542528|P1|Participant Flow|IBBS|"Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions).~IBBS: Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions)."
206129|NCT01542528|O2|Outcome|Treatment as Usual (TAU)|Whatever care arrangement the parents have arranged for their child during the same two hour period over the same 15 week period.
206154|NCT01542372|O1|Outcome|Medication Augmentation (Prazosin)|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
206231|NCT01541930|O2|Outcome|GK567, Day 7|Metronidazole Gel 0.75%, Pain evaluation on Day 7 by Visual Analogue Scale (mm)
207172|NCT01537120|O1|Outcome|Placebo|Placebo tablets twice daily for 3 weeks
206130|NCT01542528|O1|Outcome|IBBS|"Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions).~IBBS: Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions)."
206131|NCT01542528|O2|Outcome|Treatment as Usual (TAU)|Whatever care arrangement the parents have arranged for their child during the same two hour period over the same 15 week period.
206132|NCT01542528|O1|Outcome|IBBS|"Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions).~IBBS: Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions)."
206133|NCT01542528|E2|Reported Event|Treatment as Usual (TAU)|Whatever care arrangement the parents have arranged for their child during the same two hour period over the same 15 week period.
206134|NCT01542528|E1|Reported Event|IBBS|"Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions).~IBBS: Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions)."
206135|NCT01542502|B1|Baseline|All Participants|Baseline measures for all study participants
206136|NCT01542502|P2|Participant Flow|Placebo (First) Then Anakinra (Second)|"Treatment with daily subcutaneous injections of Placebo for 14 days, followed by daily subcutaneous injections of Anakinra for 14 days~Placebo: Placebo daily subcutaneous injection Anakinra: Anakinra 100 mg daily subcutaneous injection"
206137|NCT01542502|P1|Participant Flow|Anakinra (First) Then Placebo (Second)|"Treatment with daily subcutaneous injections of Anakinra 100 mg for 14 days, followed by daily subcutaneous injections of Placebo for 14 days~Anakinra: Anakinra 100 mg daily subcutaneous injection Placebo: Placebo daily subcutaneous injection"
206138|NCT01542502|O2|Outcome|Placebo|"Treatment with daily subcutaneous injection of placebo~Placebo: Placebo daily subcutaneous injection"
206139|NCT01542502|O1|Outcome|Anakinra|"Treatment with daily subcutaneous injections of Anakinra~Anakinra: Anakinra 100 mg daily subcutaneous injection"
206140|NCT01542502|O2|Outcome|Placebo|"Treatment with daily subcutaneous injection of placebo~Placebo: Placebo daily subcutaneous injection"
206141|NCT01542502|O1|Outcome|Anakinra|"Treatment with daily subcutaneous injections of Anakinra 100 mg~Anakinra: Anakinra 100 mg daily subcutaneous injection"
206142|NCT01542502|E2|Reported Event|Placebo|"Treatment with daily subcutaneous injection of placebo~Placebo: Placebo daily subcutaneous injection"
206143|NCT01542502|E1|Reported Event|Anakinra|"Treatment with daily subcutaneous injections of Anakinra 100 mg~Anakinra: Anakinra 100 mg daily subcutaneous injection"
206144|NCT01542372|B1|Baseline|Step I: SSRI/SSRN Treatment of PTSD|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
206145|NCT01542372|P2|Participant Flow|CBT Augmentation|"In this arm, patients were given CBT to treat SSRI/SSRN-resistant PTSD.~Cognitive Behavioral Therapy for PTSD: This is a culturally sensitive CBT for the treatment of PTSD"
206146|NCT01542372|P1|Participant Flow|Medication Augmentation (Prazosin)|"In this arm, the patients were given a medication augmentation for SSRI/SSRN-resistant PTSD, with the preferred first-line agent being prazosin.~Prazosin as first-line agent: Prazosin .5 to 2 mg"
206147|NCT01542372|O2|Outcome|CBT Augmentation|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
206148|NCT01542372|O1|Outcome|Medication Augmentation (Prazosin)|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
206149|NCT01542372|O2|Outcome|CBT Augmentation|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
206150|NCT01542372|O1|Outcome|Medication Augmentation (Prazosin)|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
206151|NCT01542372|O2|Outcome|CBT Augmentation|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
206152|NCT01542372|O1|Outcome|Medication Augmentation (Prazosin)|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
206153|NCT01542372|O2|Outcome|CBT Augmentation|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
206155|NCT01542372|O2|Outcome|CBT Augmentation|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
206156|NCT01542372|O1|Outcome|Medication Augmentation (Prazosin)|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
206157|NCT01542372|O2|Outcome|CBT Augmentation|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
206158|NCT01542372|O1|Outcome|Medication Augmentation (Prazosin)|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
206159|NCT01542372|E1|Reported Event|Step I and Step 2|Step 1 is treatment with SSRI or SSRN. Step 2 is Medication or CBT augmentation.
206160|NCT01542307|B1|Baseline|Enrolled Subjects|Oxygen or Medical Air is inhaled in random order for 30 minutes during each migraine attack (total 4 attacks)
206161|NCT01542307|P2|Participant Flow|Medical Air-treated Migraine Attacks|Medical air is inhaled for 30 minutes during a migraine attack
206162|NCT01542307|P1|Participant Flow|Oxygen-treated Migraine Attacks|Oxygen is inhaled for 30 minutes during a migraine attack
206163|NCT01542307|O2|Outcome|Room Air|"Medical air inhaled for 30 minutes during migraine attack~Room air: Placebo"
206164|NCT01542307|O1|Outcome|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack~Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
206165|NCT01542307|O2|Outcome|Room Air|"Medical air inhaled for 30 minutes during migraine attack~Room air: Placebo"
206166|NCT01542307|O1|Outcome|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack~Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
206167|NCT01542307|O2|Outcome|Room Air|"Medical air inhaled for 30 minutes during migraine attack~Room air: Placebo"
206168|NCT01542307|O1|Outcome|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack~Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
206169|NCT01542307|O2|Outcome|Room Air|"Medical air inhaled for 30 minutes during migraine attack~Room air: Placebo"
206170|NCT01542307|O1|Outcome|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack~Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
206171|NCT01542307|O2|Outcome|Room Air|"Medical air inhaled for 30 minutes during migraine attack~Room air: Placebo"
206172|NCT01542307|O1|Outcome|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack~Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
206173|NCT01542307|O2|Outcome|Room Air|"Medical air inhaled for 30 minutes during migraine attack~Room air: Placebo"
206174|NCT01542307|O1|Outcome|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack~Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
206175|NCT01542307|O2|Outcome|Room Air|"Medical air inhaled for 30 minutes during migraine attack~Room air: Placebo"
206176|NCT01542307|O1|Outcome|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack~Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
206177|NCT01542307|O2|Outcome|Room Air|"Medical air inhaled for 30 minutes during migraine attack~Room air: Placebo"
206178|NCT01542307|O1|Outcome|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack~Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
206179|NCT01542307|E2|Reported Event|Room Air|"Medical air inhaled for 30 minutes during migraine attack~Room air: Placebo"
206180|NCT01542307|E1|Reported Event|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack~Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
206181|NCT01542255|B1|Baseline|Combined Low Dose Treatment|"A cycle of therapy is 3 weeks of continuous dosing with a 1 week rest.~Schema of treatment is:~1 mg/m2 vinblastine three times a week iv 60 mg/m2 cyclophosphamide by mouth 15 mg/m2 dacarbazine three times a week iv~vinblastine: 1 mg/m2 vinblastine given three times per week administered intravenously.~Cyclophosphamide: 60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest~dacarbazine: 15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest"
206182|NCT01542255|P1|Participant Flow|Combined Low Dose Treatment|"A cycle of therapy is 3 weeks of continuous dosing with a 1 week rest.~Schema of treatment is:~1 mg/m2 vinblastine three times a week iv 60 mg/m2 cyclophosphamide by mouth 15 mg/m2 dacarbazine three times a week iv~vinblastine: 1 mg/m2 vinblastine given three times per week administered intravenously.~Cyclophosphamide: 60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest~dacarbazine: 15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest"
206183|NCT01542255|O1|Outcome|Single Arm|
206184|NCT01542255|E1|Reported Event|Single Arm|all patients received cyclophosphamide, DTIC and vinblastine
206185|NCT01542125|B3|Baseline|Total|Total of all reporting groups
206186|NCT01542125|B2|Baseline|Placebo Group|"This group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing.~Placebo: Tubes were visually identical to the Liposomal Lidocaine tubes."
206187|NCT01542125|B1|Baseline|Liposomal Lidocaine Group|"Patients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing~Liposomal Lidocaine: 4% Liposomal Lidocaine"
206188|NCT01542125|P2|Participant Flow|Placebo Group|"This group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing.~Placebo: Tubes were visually identical to the Liposomal Lidocaine tubes."
206189|NCT01542125|P1|Participant Flow|Liposomal Lidocaine Group|"Patients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing~Liposomal Lidocaine: 4% Liposomal Lidocaine"
206190|NCT01542125|O2|Outcome|Placebo Group|"This group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing.~Placebo: Tubes were visually identical to the Liposomal Lidocaine tubes."
206224|NCT01541969|O2|Outcome|Tinnitus Masking|see Protocol section for details
206225|NCT01541969|O1|Outcome|CR Neuromodulation|see Protocol section for details
206191|NCT01542125|O1|Outcome|Liposomal Lidocaine Group|"Patients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing~Liposomal Lidocaine: 4% Liposomal Lidocaine"
206192|NCT01542125|E2|Reported Event|Placebo Group|"This group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing.~Placebo: Tubes were visually identical to the Liposomal Lidocaine tubes."
206193|NCT01542125|E1|Reported Event|Liposomal Lidocaine Group|"Patients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing~Liposomal Lidocaine: 4% Liposomal Lidocaine"
206194|NCT01542034|B3|Baseline|Total|Total of all reporting groups
206195|NCT01542034|B2|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
206196|NCT01542034|B1|Baseline|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
206197|NCT01542034|P2|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
206198|NCT01542034|P1|Participant Flow|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
206199|NCT01542034|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
206200|NCT01542034|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
206201|NCT01542034|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
206202|NCT01542034|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
206203|NCT01542034|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
206204|NCT01542034|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
206205|NCT01542034|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
206206|NCT01542034|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
206207|NCT01542034|E2|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
206208|NCT01542034|E1|Reported Event|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
206209|NCT01541969|B3|Baseline|Total|Total of all reporting groups
206210|NCT01541969|B2|Baseline|Tinnitus Masking|see Protocol section for details
206211|NCT01541969|B1|Baseline|CR Neuromodulation|see Protocol section for details
206212|NCT01541969|P2|Participant Flow|Tinnitus Masking|"The active control group had the same ear level device which delivers patterned sound stimulation. Participants were asked to wear the device for 4-6 hours per day (0-36 weeks).~The active comparator group received the intervention in a double-blind RCT (0-12 weeks). They received the same device as the treatment group but the sound stimulation was determined according to an algorithm predicted not to break up tinnitus generating activity in the brain. The device may have a tinnitus masking effect in the active comparator group.~After the first 12 weeks, the participants entered into the open-label extension (unblinded, 12-36 weeks) in which they received the verum experimental intervention."
206213|NCT01541969|P1|Participant Flow|CR Neuromodulation|"Acoustic Co-ordinated Reset (CR) Neuromodulation includes an ear level device which delivers patterned sound stimulation. Participants were asked to wear the device for 4-6 hours per day (0-12 weeks) and for at least 4 hours daily (12-36 weeks)~The experimental arm received the intervention in a double-blind RCT (0-12 weeks), with the device fitted according to audiologist training given by the manufacturer/funder. An individually specified sound stimulation algorithm is hypothesised to interrupt tinnitus generating activity in the brain.~After the first 12 weeks, the participants entered into the open-label extension (unblinded, 12-36 weeks) in which they continued with the same experimental intervention."
206214|NCT01541969|O2|Outcome|Tinnitus Masking|The active comparator group were unblinded at 12 weeks and the device algorithm was reprogrammed in the same way as the experimental intervention. At 36 weeks, this group had therefore received a mixture of placebo (0-12 weeks) and active treatment (12-36 weeks).
206215|NCT01541969|O1|Outcome|CR Neuromodulation|The treatment group were unblinded at 12 weeks and then continued to receive the same experimental intervention. At 36 weeks, this group had therefore received active treatment (0-36 weeks).
206216|NCT01541969|O2|Outcome|Tinnitus Masking|see Protocol section for details
206217|NCT01541969|O1|Outcome|CR Neuromodulation|see Protocol section for details
206218|NCT01541969|O2|Outcome|Tinnitus Masking|see Protocol section for details
206219|NCT01541969|O1|Outcome|CR Neuromodulation|see Protocol section for details
206220|NCT01541969|O2|Outcome|Tinnitus Masking|see Protocol section for details
206221|NCT01541969|O1|Outcome|CR Neuromodulation|see Protocol section for details
206222|NCT01541969|O2|Outcome|Tinnitus Masking|see Protocol section for details.
206223|NCT01541969|O1|Outcome|CR Neuromodulation|see Protocol section for details
206233|NCT01541930|O3|Outcome|GK567, Day 14|Metronidazole Gel 0.75%, Appearance score evaluated on Day 14. One patient was withdrawn on Day 7 by Subject's request.
206234|NCT01541930|O2|Outcome|GK567, Day 7|Metronidazole Gel 0.75%, Appearance score evaluated on Day 7
206235|NCT01541930|O1|Outcome|GK567, Day 0|Metronidazole Gel 0.75%, Appearance score evaluated on Day 0 (baseline)
206236|NCT01541930|O3|Outcome|GK567, Day 14|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 14. One patient was withdrawn on Day 7 by Subject's request.
206237|NCT01541930|O2|Outcome|GK567, Day 7|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 7
206238|NCT01541930|O1|Outcome|GK567, Day 0|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 0 (baseline)
206239|NCT01541930|O3|Outcome|GK567, Day 14|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 14. One patient was withdrawn on Day 7 by Subject's request.
206240|NCT01541930|O2|Outcome|GK567, Day 7|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 7
206241|NCT01541930|O1|Outcome|GK567, Day 0|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 0 (baseline)
206242|NCT01541930|O3|Outcome|GK567, Day 14|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 14. One patient was withdrawn on Day 7 due to subject's request.
206243|NCT01541930|O2|Outcome|GK567, Day 7|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 7
206244|NCT01541930|O1|Outcome|GK567, Day 0|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 0 (Baseline)
206245|NCT01541930|O1|Outcome|GK567|Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g
206246|NCT01541930|E1|Reported Event|GK567|Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30 g
206247|NCT01541917|B4|Baseline|Total|Total of all reporting groups
206248|NCT01541917|B3|Baseline|Never Randomized|This group comprises participants that consented but were never randomized to a condition due to being determined to not meet eligibility criteria or self-withdrawing before randomization.
206249|NCT01541917|B2|Baseline|Online Disease Education Control|The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual health coach to discuss the participant's efforts at managing his/her disease.
206250|NCT01541917|B1|Baseline|Web-based Coping Skills Training|This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach to review material and help enhance motivation.
206251|NCT01541917|P2|Participant Flow|Online Disease Education Control|"Involves viewing 12 educational websites about Juvenile Idiopathic Arthritis over the course of 12 weeks.~Online disease education: The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse “health coach to discuss the participant's efforts at managing his/her disease."
206252|NCT01541917|P1|Participant Flow|Web-based Coping Skills Training|"Involves completion of a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support.~Web-based coping skills training: This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation."
206253|NCT01541917|O2|Outcome|Online Disease Education Control|"The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse “health coach to discuss the participant's efforts at managing his/her disease."
206254|NCT01541917|O1|Outcome|Web-based Coping Skills Training|This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
206255|NCT01541917|O2|Outcome|Online Disease Education Control|"The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse “health coach to discuss the participant's efforts at managing his/her disease."
206256|NCT01541917|O1|Outcome|Web-based Coping Skills Training|This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
206257|NCT01541917|O2|Outcome|Online Disease Education Control|"The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse “health coach to discuss the participant's efforts at managing his/her disease."
206279|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
206258|NCT01541917|O1|Outcome|Web-based Coping Skills Training|This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
206259|NCT01541917|O2|Outcome|Online Disease Education|"The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse “health coach to discuss the participant's efforts at managing his/her disease."
206260|NCT01541917|O1|Outcome|Web-based Coping Skills Training|This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
206261|NCT01541917|O2|Outcome|Online Disease Education|"Involves viewing 12 educational websites about Juvenile Idiopathic Arthritis over the course of 12 weeks.~Online disease education: The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse “health coach to discuss the participant's efforts at managing his/her disease."
206262|NCT01541917|O1|Outcome|Web-based Coping Skills Training|"Involves completion of a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support.~Web-based coping skills training: This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation."
206263|NCT01541917|O2|Outcome|Online Disease Education Control|"The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse “health coach to discuss the participant's efforts at managing his/her disease."
206264|NCT01541917|O1|Outcome|Web-based Coping Skills Training|This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
206265|NCT01541917|E2|Reported Event|Online Disease Education Control|"The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse “health coach to discuss the participant's efforts at managing his/her disease."
206266|NCT01541917|E1|Reported Event|Web-based Coping Skills Training|This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
206267|NCT01541865|B1|Baseline|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
206268|NCT01541865|P1|Participant Flow|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
206269|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
206270|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
206271|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
206272|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
206273|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
206274|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
206275|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
206276|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
206277|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
206278|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
206401|NCT01541384|B4|Baseline|Total|Total of all reporting groups
206280|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
206281|NCT01541865|E1|Reported Event|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
206282|NCT01541826|B4|Baseline|Total|Total of all reporting groups
206283|NCT01541826|B3|Baseline|Chokeberry Extract Capsule (Acute)|Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose.
206284|NCT01541826|B2|Baseline|Chokeberry Extract Capsule|"Chokeberry extract capsule~Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks."
206285|NCT01541826|B1|Baseline|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206286|NCT01541826|P3|Participant Flow|Chaokeberry Extract Capsule (Acute)|Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose.
206287|NCT01541826|P2|Participant Flow|Chokeberry Extract Capsule|"Chokeberry extract capsule~Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.~Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose."
206288|NCT01541826|P1|Participant Flow|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206289|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206290|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206291|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206292|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206293|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206294|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206295|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206296|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206297|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206298|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206299|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206300|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206301|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206302|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206303|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206304|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206305|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206306|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206307|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206308|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206309|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206310|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206311|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206312|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206313|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206314|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206315|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206316|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206317|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206318|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206319|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206320|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206321|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
207173|NCT01537120|E2|Reported Event|Placebo|Placebo tablets twice daily for 3 weeks
206322|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206323|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206324|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206325|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206326|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206327|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206328|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206329|NCT01541826|O1|Outcome|Chokeberry Extract Capsule (Acute)|Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose.
206330|NCT01541826|O1|Outcome|Chokeberry Extract Capsule (Acute)|Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose.
206331|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206332|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206333|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206334|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206335|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206336|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206337|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206338|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206339|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206340|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206341|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206342|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206343|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206344|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206345|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206346|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206347|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206348|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206349|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206350|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206351|NCT01541826|E3|Reported Event|Chokeberry Extract Capsule (Acute)|Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose.
206352|NCT01541826|E2|Reported Event|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
206353|NCT01541826|E1|Reported Event|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
206354|NCT01541735|B3|Baseline|Total|Total of all reporting groups
206355|NCT01541735|B2|Baseline|Placebo|Placebo of calcined magnesia, capsules
206356|NCT01541735|B1|Baseline|Pantoprazole|The pantoprazole will be administered in 40mg capsules
206357|NCT01541735|P2|Participant Flow|Placebo|Placebo of calcined magnesia, capsules PO, 30 minutes before to breakfast during 45 days
206358|NCT01541735|P1|Participant Flow|Pantoprazole|The pantoprazole will be administered in 40mg capsules PO, 30 minutes before to breakfast during 45 days
206359|NCT01541735|O2|Outcome|Placebo|Placebo of calcined magnesia, capsules
206360|NCT01541735|O1|Outcome|Pantoprazole|The pantoprazole will be administered in 40mg capsules
206361|NCT01541735|O2|Outcome|Placebo|Placebo of calcined magnesia, capsules
206362|NCT01541735|O1|Outcome|Pantoprazole|The pantoprazole will be administered in 40mg capsules
206363|NCT01541735|O2|Outcome|Placebo|Placebo of calcined magnesia, capsules
206364|NCT01541735|O1|Outcome|Pantoprazole|The pantoprazole will be administered in 40mg capsules
206365|NCT01541735|O2|Outcome|Placebo|Placebo of calcined magnesia, capsules
206366|NCT01541735|O1|Outcome|Pantoprazole|The pantoprazole will be administered in 40mg capsules
206367|NCT01541735|E2|Reported Event|Placebo|Placebo of calcined magnesia, capsules
206368|NCT01541735|E1|Reported Event|Pantoprazole|The pantoprazole will be administered in 40mg capsules
206402|NCT01541384|B3|Baseline|Usual Care With GlowCap|"Subject will receive electronic pill bottle that will track adherence but all reminders will be deactivated.~Electronic pill bottle: Device will remotely track adherence but reminders/alerts are deactivated."
206369|NCT01541644|B1|Baseline|Acupuncture|"All participants will receive acupuncture treatments over a total of 10 weeks.~Acupuncture: Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks."
206370|NCT01541644|P1|Participant Flow|Acupuncture|"All participants will receive acupuncture treatments over a total of 10 weeks.~Acupuncture: Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks."
206371|NCT01541644|O1|Outcome|Acupuncture|"All participants will receive acupuncture treatments over a total of 10 weeks.~Acupuncture: Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks."
206372|NCT01541644|E1|Reported Event|Acupuncture|"All participants will receive acupuncture treatments over a total of 10 weeks.~Acupuncture: Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks."
206373|NCT01541553|B3|Baseline|Total|Total of all reporting groups
206374|NCT01541553|B2|Baseline|Vehicle Gel|"Cryotherapy followed by vehicle gel~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
206375|NCT01541553|B1|Baseline|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
206376|NCT01541553|P2|Participant Flow|Vehicle Gel|"Cryotherapy followed by vehicle gel~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
206377|NCT01541553|P1|Participant Flow|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
206378|NCT01541553|O2|Outcome|Vehicle Gel|"Cryotherapy followed by vehicle gel~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
206379|NCT01541553|O1|Outcome|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
206380|NCT01541553|O2|Outcome|Vehicle Gel|"Cryotherapy followed by vehicle gel~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
206381|NCT01541553|O1|Outcome|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
206382|NCT01541553|O2|Outcome|Vehicle Gel|"Cryotherapy followed by vehicle gel~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
206383|NCT01541553|O1|Outcome|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
206384|NCT01541553|E2|Reported Event|Vehicle Gel|"Cryotherapy followed by vehicle gel~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
206385|NCT01541553|E1|Reported Event|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
206386|NCT01541397|B3|Baseline|Total|Total of all reporting groups
206387|NCT01541397|B2|Baseline|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).~Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
206388|NCT01541397|B1|Baseline|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
206389|NCT01541397|P2|Participant Flow|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).~Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
206390|NCT01541397|P1|Participant Flow|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
206391|NCT01541397|O2|Outcome|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).~Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
206392|NCT01541397|O1|Outcome|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
206393|NCT01541397|O2|Outcome|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).~Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
206394|NCT01541397|O1|Outcome|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
206395|NCT01541397|O2|Outcome|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).~Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
206396|NCT01541397|O1|Outcome|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
206397|NCT01541397|O2|Outcome|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).~Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
206398|NCT01541397|O1|Outcome|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
206399|NCT01541397|E2|Reported Event|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).~Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
206400|NCT01541397|E1|Reported Event|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
206403|NCT01541384|B2|Baseline|Medicaiton Dosage Reminders + Coordinator Support|"Subject will receive electronic pill bottle that will track adherence. They will also be able to activate available dosage reminders (text message, phone message, email). The study coordinator will also check adherence every 2 weeks and alert the transplant team when it drops below 90%. The transplant team will determine the next best course of action.~Electronic pill bottle: The main research instrument is an electronic pill bottle called GlowCaps that has the ability to transmit reminder messages via email, text, and phone to the subject, and adherence data to special servers. The messages will be sent twice a day, if a subject misses a dose of their immunosuppression medication (tacrolimus). Each time the pill bottle is opened (or not opened), a date- and time-stamped wireless signal is sent to the Vitality server via the AT&T cellular network. No extra cellular or wireless service is required from subjects for the GlowCap to function."
206404|NCT01541384|B1|Baseline|Medication Dosage Reminders|"Subject will receive electronic pill bottle that will track adherence. They will also be able to activate available dosage reminders (text message, phone message, email).~Electronic pill bottle: The main research instrument is an electronic pill bottle called GlowCaps that has the ability to transmit reminder messages via email, text, and phone to the subject, and adherence data to special servers. The messages will be sent twice a day, if a subject misses a dose of their immunosuppression medication (tacrolimus). Each time the pill bottle is opened (or not opened), a date- and time-stamped wireless signal is sent to the Vitality server via the AT&T cellular network. No extra cellular or wireless service is required from subjects for the GlowCap to function."
206405|NCT01541384|P3|Participant Flow|Usual Care With GlowCap|"Subject will receive electronic pill bottle that will track adherence but all reminders will be deactivated.~Electronic pill bottle: Device will remotely track adherence but reminders/alerts are deactivated."
206406|NCT01541384|P2|Participant Flow|Medicaiton Dosage Reminders + Coordinator Support|"Subject will receive electronic pill bottle that will track adherence. They will also be able to activate available dosage reminders (text message, phone message, email). The study coordinator will also check adherence every 2 weeks and alert the transplant team when it drops below 90%. The transplant team will determine the next best course of action.~Electronic pill bottle: The main research instrument is an electronic pill bottle called GlowCaps that has the ability to transmit reminder messages via email, text, and phone to the subject, and adherence data to special servers. The messages will be sent twice a day, if a subject misses a dose of their immunosuppression medication (tacrolimus). Each time the pill bottle is opened (or not opened), a date- and time-stamped wireless signal is sent to the Vitality server via the AT&T cellular network. No extra cellular or wireless service is required from subjects for the GlowCap to function."
206407|NCT01541384|P1|Participant Flow|Medication Dosage Reminders|"Subject will receive electronic pill bottle that will track adherence. They will also be able to activate available dosage reminders (text message, phone message, email).~Electronic pill bottle: The main research instrument is an electronic pill bottle called GlowCaps that has the ability to transmit reminder messages via email, text, and phone to the subject, and adherence data to special servers. The messages will be sent twice a day, if a subject misses a dose of their immunosuppression medication (tacrolimus). Each time the pill bottle is opened (or not opened), a date- and time-stamped wireless signal is sent to the Vitality server via the AT&T cellular network. No extra cellular or wireless service is required from subjects for the GlowCap to function."
206408|NCT01541384|O3|Outcome|Usual Care With GlowCap|"Subject will receive electronic pill bottle that will track adherence but all reminders will be deactivated.~Electronic pill bottle: Device will remotely track adherence but reminders/alerts are deactivated."
206409|NCT01541384|O2|Outcome|Medicaiton Dosage Reminders + Coordinator Support|"Subject will receive electronic pill bottle that will track adherence. They will also be able to activate available dosage reminders (text message, phone message, email). The study coordinator will also check adherence every 2 weeks and alert the transplant team when it drops below 90%. The transplant team will determine the next best course of action.~Electronic pill bottle: The main research instrument is an electronic pill bottle called GlowCaps that has the ability to transmit reminder messages via email, text, and phone to the subject, and adherence data to special servers. The messages will be sent twice a day, if a subject misses a dose of their immunosuppression medication (tacrolimus). Each time the pill bottle is opened (or not opened), a date- and time-stamped wireless signal is sent to the Vitality server via the AT&T cellular network. No extra cellular or wireless service is required from subjects for the GlowCap to function."
206410|NCT01541384|O1|Outcome|Medication Dosage Reminders|"Subject will receive electronic pill bottle that will track adherence. They will also be able to activate available dosage reminders (text message, phone message, email).~Electronic pill bottle: The main research instrument is an electronic pill bottle called GlowCaps that has the ability to transmit reminder messages via email, text, and phone to the subject, and adherence data to special servers. The messages will be sent twice a day, if a subject misses a dose of their immunosuppression medication (tacrolimus). Each time the pill bottle is opened (or not opened), a date- and time-stamped wireless signal is sent to the Vitality server via the AT&T cellular network. No extra cellular or wireless service is required from subjects for the GlowCap to function."
206411|NCT01541384|E3|Reported Event|Usual Care With GlowCap|"Subject will receive electronic pill bottle that will track adherence but all reminders will be deactivated.~Electronic pill bottle: Device will remotely track adherence but reminders/alerts are deactivated."
206412|NCT01541384|E2|Reported Event|Medicaiton Dosage Reminders + Coordinator Support|"Subject will receive electronic pill bottle that will track adherence. They will also be able to activate available dosage reminders (text message, phone message, email). The study coordinator will also check adherence every 2 weeks and alert the transplant team when it drops below 90%. The transplant team will determine the next best course of action.~Electronic pill bottle: The main research instrument is an electronic pill bottle called GlowCaps that has the ability to transmit reminder messages via email, text, and phone to the subject, and adherence data to special servers. The messages will be sent twice a day, if a subject misses a dose of their immunosuppression medication (tacrolimus). Each time the pill bottle is opened (or not opened), a date- and time-stamped wireless signal is sent to the Vitality server via the AT&T cellular network. No extra cellular or wireless service is required from subjects for the GlowCap to function."
206454|NCT01540981|O1|Outcome|SOC - Standard of Care|"Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed~Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed"
206413|NCT01541384|E1|Reported Event|Medication Dosage Reminders|"Subject will receive electronic pill bottle that will track adherence. They will also be able to activate available dosage reminders (text message, phone message, email).~Electronic pill bottle: The main research instrument is an electronic pill bottle called GlowCaps that has the ability to transmit reminder messages via email, text, and phone to the subject, and adherence data to special servers. The messages will be sent twice a day, if a subject misses a dose of their immunosuppression medication (tacrolimus). Each time the pill bottle is opened (or not opened), a date- and time-stamped wireless signal is sent to the Vitality server via the AT&T cellular network. No extra cellular or wireless service is required from subjects for the GlowCap to function."
206414|NCT01541371|B1|Baseline|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator’s discretion once daily for 12 weeks.
206415|NCT01541371|P1|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral (by mouth) tablets depending on Investigator’s discretion once daily for 12 weeks.
206416|NCT01541371|O3|Outcome|Other Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
206417|NCT01541371|O2|Outcome|Lack of Tolerability Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
206418|NCT01541371|O1|Outcome|Lack of Efficacy Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
206419|NCT01541371|O3|Outcome|Other Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
206420|NCT01541371|O2|Outcome|Lack of Tolerability Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
206421|NCT01541371|O1|Outcome|Lack of Efficacy Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
206422|NCT01541371|O3|Outcome|Other Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
206423|NCT01541371|O2|Outcome|Lack of Tolerability Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
206424|NCT01541371|O1|Outcome|Lack of Efficacy Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
206425|NCT01541371|O3|Outcome|Other Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
206426|NCT01541371|O2|Outcome|Lack of Tolerability Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
206427|NCT01541371|O1|Outcome|Lack of Efficacy Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
206428|NCT01541371|O3|Outcome|Other Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
206429|NCT01541371|O2|Outcome|Lack of Tolerability Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
206455|NCT01540981|O2|Outcome|MIST Therapy With SOC|"Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days~MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area."
206430|NCT01541371|O1|Outcome|Lack of Efficacy Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
206431|NCT01541371|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator’s discretion once daily for 12 weeks.
206432|NCT01541371|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator’s discretion once daily for 12 weeks.
206433|NCT01541371|O3|Outcome|Other Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
206434|NCT01541371|O2|Outcome|Lack of Tolerability Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
206435|NCT01541371|O1|Outcome|Lack of Efficacy Group|Paliperidone extended release (ER) tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
206436|NCT01541371|E1|Reported Event|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator’s discretion once daily for 12 weeks.
206437|NCT01541358|B1|Baseline|Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)|
206438|NCT01541358|P1|Participant Flow|Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)|"Patients were injected with approximately 5mCi F18 NaF and undergo a PET/CT scan approximately 60 minutes later.~A whole body non-contrast CT was obtained for attenuation correction and anatomic localization of radiotracer activity. Positron emission tomographic scans were obtained over the same anatomical regions as the CT scan. Images were reconstructed and reviewed in the axial, coronal, and sagittal planes."
206439|NCT01541358|O1|Outcome|Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)|"Patients were injected with approximately 5mCi F18 NaF and underwent a PET/CT scan approximately 60 minutes later.~A whole body non-contrast CT was obtained for attenuation correction and anatomic localization of radiotracer activity. Positron emission tomographic scans were obtained over the same anatomical regions as the CT scan. Images were reconstructed and reviewed in the axial, coronal, and sagittal planes."
206440|NCT01541358|O1|Outcome|Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)|"Patients were injected with approximately 5mCi F18 NaF and undergo a PET/CT scan approximately 60 minutes later.~A whole body non-contrast CT was obtained for attenuation correction and anatomic localization of radiotracer activity. Positron emission tomographic scans were obtained over the same anatomical regions as the CT scan. Images were reconstructed and reviewed in the axial, coronal, and sagittal planes."
206441|NCT01541358|O1|Outcome|Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)|"Patients were injected with approximately 5mCi F18 NaF and underwent a PET/CT scan approximately 60 minutes later.~A whole body non-contrast CT was obtained for attenuation correction and anatomic localization of radiotracer activity. Positron emission tomographic scans were obtained over the same anatomical regions as the CT scan. Images were reconstructed and reviewed in the axial, coronal, and sagittal planes."
206442|NCT01541358|E1|Reported Event|Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)|"Patients undergo fluorine F 18 sodium fluoride PET/CT scan.~fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET/CT scan~positron emission tomography/computed tomography: Undergo fluorine F 18 sodium fluoride PET/CT scan"
206443|NCT01541254|B1|Baseline|Single Arm|Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
206444|NCT01541254|P1|Participant Flow|Single Arm|"Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)~Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.): Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)"
206445|NCT01541254|O1|Outcome|Single Arm|Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
206446|NCT01541254|O1|Outcome|Single Arm|Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
206447|NCT01541254|E1|Reported Event|Single Arm|Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
206448|NCT01540981|B3|Baseline|Total|Total of all reporting groups
206449|NCT01540981|B2|Baseline|MIST Therapy With SOC|"Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days~MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area."
206450|NCT01540981|B1|Baseline|SOC - Standard of Care|"Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed~Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed"
206451|NCT01540981|P2|Participant Flow|MIST Therapy With SOC|"Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days~MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area."
206452|NCT01540981|P1|Participant Flow|SOC - Standard of Care|"Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed~Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed"
206453|NCT01540981|O2|Outcome|MIST Therapy With SOC|"Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days~MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area."
206590|NCT01540773|P2|Participant Flow|Placebo - Amino Acid Supplement|Placebo
206456|NCT01540981|O1|Outcome|SOC - Standard of Care|"Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed~Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed"
206457|NCT01540981|E2|Reported Event|MIST Therapy With SOC|"Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days~MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area."
206458|NCT01540981|E1|Reported Event|SOC - Standard of Care|"Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed~Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed"
206459|NCT01540851|B3|Baseline|Total|Total of all reporting groups
206460|NCT01540851|B2|Baseline|Usual Care Group|"Subjects in the Usual Care group receive the current standard post-operative TKA care~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
206461|NCT01540851|B1|Baseline|Care Navigator Intervention Group|"Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
206462|NCT01540851|P2|Participant Flow|Usual Care Group|"Subjects in the Usual Care group receive the current standard post-operative TKA care~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
206463|NCT01540851|P1|Participant Flow|Care Navigator Intervention Group|"Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
206464|NCT01540851|O2|Outcome|Usual Care Group|Subjects in the Usual Care group receive the current standard post-operative TKA care
206465|NCT01540851|O1|Outcome|Care Navigator Intervention Group|Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively
206466|NCT01540851|O2|Outcome|Usual Care Group|Subjects in the Usual Care group receive the current standard post-operative TKA care
206467|NCT01540851|O1|Outcome|Care Navigator Intervention Group|Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively
206468|NCT01540851|O2|Outcome|Usual Care Group|"Subjects in the Usual Care group receive the current standard post-operative TKA care~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
206469|NCT01540851|O1|Outcome|Care Navigator Intervention Group|"Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
206470|NCT01540851|E2|Reported Event|Usual Care Group|"Subjects in the Usual Care group receive the current standard post-operative TKA care~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
206471|NCT01540851|E1|Reported Event|Care Navigator Intervention Group|"Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
206472|NCT01540825|B12|Baseline|Total|Total of all reporting groups
206473|NCT01540825|B11|Baseline|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
206474|NCT01540825|B10|Baseline|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
206475|NCT01540825|B9|Baseline|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
206476|NCT01540825|B8|Baseline|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
206477|NCT01540825|B7|Baseline|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
206478|NCT01540825|B6|Baseline|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
206479|NCT01540825|B5|Baseline|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
206480|NCT01540825|B4|Baseline|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
206481|NCT01540825|B3|Baseline|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
206482|NCT01540825|B2|Baseline|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
206483|NCT01540825|B1|Baseline|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
206484|NCT01540825|P11|Participant Flow|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
206485|NCT01540825|P10|Participant Flow|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
206486|NCT01540825|P9|Participant Flow|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
206487|NCT01540825|P8|Participant Flow|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
206488|NCT01540825|P7|Participant Flow|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
206489|NCT01540825|P6|Participant Flow|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
206490|NCT01540825|P5|Participant Flow|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
206491|NCT01540825|P4|Participant Flow|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
206492|NCT01540825|P3|Participant Flow|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
206493|NCT01540825|P2|Participant Flow|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
206494|NCT01540825|P1|Participant Flow|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
206495|NCT01540825|O11|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
206496|NCT01540825|O10|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
206497|NCT01540825|O9|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
206498|NCT01540825|O8|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
206499|NCT01540825|O7|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
206500|NCT01540825|O6|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
206501|NCT01540825|O5|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
206502|NCT01540825|O4|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
206503|NCT01540825|O3|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
206504|NCT01540825|O2|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
206505|NCT01540825|O1|Outcome|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
206506|NCT01540825|O11|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
206507|NCT01540825|O10|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
206508|NCT01540825|O9|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
206509|NCT01540825|O8|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
206510|NCT01540825|O7|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
206511|NCT01540825|O6|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
206512|NCT01540825|O5|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
206513|NCT01540825|O4|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
206514|NCT01540825|O3|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
206515|NCT01540825|O2|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
206516|NCT01540825|O1|Outcome|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
206517|NCT01540825|O10|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
206518|NCT01540825|O9|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
206519|NCT01540825|O8|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
206520|NCT01540825|O7|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
206521|NCT01540825|O6|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
206522|NCT01540825|O5|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
206523|NCT01540825|O4|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
206524|NCT01540825|O3|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
206525|NCT01540825|O2|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
206526|NCT01540825|O1|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
206527|NCT01540825|O10|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
206528|NCT01540825|O9|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
206529|NCT01540825|O8|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
206530|NCT01540825|O7|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
206531|NCT01540825|O6|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
206532|NCT01540825|O5|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
206533|NCT01540825|O4|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
206534|NCT01540825|O3|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
206535|NCT01540825|O2|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
206536|NCT01540825|O1|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
206537|NCT01540825|O10|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
206538|NCT01540825|O9|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
206539|NCT01540825|O8|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
206540|NCT01540825|O7|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
206541|NCT01540825|O6|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
206542|NCT01540825|O5|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
206543|NCT01540825|O4|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
206544|NCT01540825|O3|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
206545|NCT01540825|O2|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
206546|NCT01540825|O1|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
206547|NCT01540825|O10|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
206548|NCT01540825|O9|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
206549|NCT01540825|O8|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
206550|NCT01540825|O7|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
206551|NCT01540825|O6|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
206552|NCT01540825|O5|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
206553|NCT01540825|O4|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
206554|NCT01540825|O3|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
206555|NCT01540825|O2|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
206556|NCT01540825|O1|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
206557|NCT01540825|O10|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
206558|NCT01540825|O9|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
206559|NCT01540825|O8|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
206560|NCT01540825|O7|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
206561|NCT01540825|O6|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
206562|NCT01540825|O5|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
206563|NCT01540825|O4|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
206564|NCT01540825|O3|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
206565|NCT01540825|O2|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
206566|NCT01540825|O1|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
206567|NCT01540825|O11|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
206568|NCT01540825|O10|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
206569|NCT01540825|O9|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
206570|NCT01540825|O8|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
206571|NCT01540825|O7|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
206572|NCT01540825|O6|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
206573|NCT01540825|O5|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
206574|NCT01540825|O4|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
206575|NCT01540825|O3|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
206576|NCT01540825|O2|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
206577|NCT01540825|O1|Outcome|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
206578|NCT01540825|E11|Reported Event|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
206579|NCT01540825|E10|Reported Event|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
206580|NCT01540825|E9|Reported Event|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
206581|NCT01540825|E8|Reported Event|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
206582|NCT01540825|E7|Reported Event|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
206583|NCT01540825|E6|Reported Event|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
206584|NCT01540825|E5|Reported Event|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
206585|NCT01540825|E4|Reported Event|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
206586|NCT01540825|E3|Reported Event|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
206587|NCT01540825|E2|Reported Event|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
206588|NCT01540825|E1|Reported Event|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
206589|NCT01540773|B1|Baseline|All Study Participants|Participants received either an egg breakfast or an isocaloric bagel breakfast.
206591|NCT01540773|P1|Participant Flow|Amino Acid Supplement - Placebo|"supplements with the proprietary amino acid derivative blend.~Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative"
206592|NCT01540773|O2|Outcome|Placebo|"Non-Active~Placebo: A non-active orally administered supplement of the proprietary amino acid derivative"
206593|NCT01540773|O1|Outcome|Amino Acid Supplement|"supplements with the proprietary amino acid derivative blend.~Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative~A single dose of amino acids can significantly increase GH levels after 120 minutes in healthy men and women. Whether these GH changes persist over a longer duration or have other positive effects is being further examined."
206594|NCT01540773|O2|Outcome|Placebo|"Non-Active~Placebo: A non-active orally administered supplement of the proprietary amino acid derivative"
206595|NCT01540773|O1|Outcome|Amino Acid Supplement|"supplements with the proprietary amino acid derivative blend.~Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative~A single dose of amino acids can significantly increase GH levels after 120 minutes in healthy men and women. Whether these GH changes persist over a longer duration or have other positive effects is being further examined."
206596|NCT01540773|E2|Reported Event|Placebo|"Non-Active~Placebo: A non-active orally administered supplement of the proprietary amino acid derivative"
206597|NCT01540773|E1|Reported Event|Amino Acid Supplement|"supplements with the proprietary amino acid derivative blend.~Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative"
206598|NCT01540513|B1|Baseline|I124-NM404 Brain Metastases or GBM Imaging|"Participants injected with 185 MBq ± of 124I-CLR1404 intravenously over a period of 1 to 2 minutes, followed by a flush of 10 mL of normal saline. Subjects returned for PET/CT imaging at 6-, 24-, and 48-hours post-injection.~Participants received 3 drops of potassium iodide by mouth (1 gm/ml) 1 to 24 hours prior to injection of 124I-CLR1404 and continued additional daily doses prior to each PET/CT scan for 3 consecutive days."
206599|NCT01540513|P1|Participant Flow|I124-NM404 Brain Metastases or GBM Imaging|"Participants injected with 185 MBq ± of 124I-CLR1404 intravenously over a period of 1 to 2 minutes, followed by a flush of 10 mL of normal saline. Subjects returned for PET/CT imaging at 6-, 24-, and 48-hours post-injection.~Participants received 3 drops of potassium iodide by mouth (1 gm/ml) 1 to 24 hours prior to injection of 124I-CLR1404 and continued additional daily doses prior to each PET/CT scan for 3 consecutive days."
206600|NCT01540513|O1|Outcome|I124-NM404 Brain Metastases or GBM Imaging|"Participants injected with 185 MBq ± of 124I-CLR1404 intravenously over a period of 1 to 2 minutes, followed by a flush of 10 mL of normal saline. Subjects returned for PET/CT imaging at 6-, 24-, and 48-hours post-injection.~Participants received 3 drops of potassium iodide by mouth (1 gm/ml) 1 to 24 hours prior to injection of 124I-CLR1404 and continued additional daily doses prior to each PET/CT scan for 3 consecutive days."
206601|NCT01540513|O1|Outcome|I124-NM404 Brain Metastases or GBM Imaging|"Participants injected with 185 MBq ± of 124I-CLR1404 intravenously over a period of 1 to 2 minutes, followed by a flush of 10 mL of normal saline. Subjects returned for PET/CT imaging at 6-, 24-, and 48-hours post-injection.~Participants received 3 drops of potassium iodide by mouth (1 gm/ml) 1 to 24 hours prior to injection of 124I-CLR1404 and continued additional daily doses prior to each PET/CT scan for 3 consecutive days."
206602|NCT01540513|O1|Outcome|I124-NM404 Brain Metastases or GBM Imaging|"Participants injected with 185 MBq ± of 124I-CLR1404 intravenously over a period of 1 to 2 minutes, followed by a flush of 10 mL of normal saline. Subjects returned for PET/CT imaging at 6-, 24-, and 48-hours post-injection.~Participants received 3 drops of potassium iodide by mouth (1 gm/ml) 1 to 24 hours prior to injection of 124I-CLR1404 and continued additional daily doses prior to each PET/CT scan for 3 consecutive days."
206603|NCT01540513|O1|Outcome|I124-NM404 Brain Metastases or GBM Imaging|"Participants injected with 185 MBq ± of 124I-CLR1404 intravenously over a period of 1 to 2 minutes, followed by a flush of 10 mL of normal saline. Subjects returned for PET/CT imaging at 6-, 24-, and 48-hours post-injection.~Participants received 3 drops of potassium iodide by mouth (1 gm/ml) 1 to 24 hours prior to injection of 124I-CLR1404 and continued additional daily doses prior to each PET/CT scan for 3 consecutive days."
206604|NCT01540513|E1|Reported Event|I124-NM404 Brain Metastases or GBM Imaging|"Participants injected with 185 MBq ± of 124I-CLR1404 intravenously over a period of 1 to 2 minutes, followed by a flush of 10 mL of normal saline. Subjects returned for PET/CT imaging at 6-, 24-, and 48-hours post-injection.~Participants received 3 drops of potassium iodide by mouth (1 gm/ml) 1 to 24 hours prior to injection of 124I-CLR1404 and continued additional daily doses prior to each PET/CT scan for 3 consecutive days."
206605|NCT01540487|B3|Baseline|Total|Total of all reporting groups
206606|NCT01540487|B2|Baseline|Lina 2.5mg, Metformin 500mg|All patients receiving Linagliptin 2.5mg and Metformin 500mg.
206607|NCT01540487|B1|Baseline|Lina 2.5mg, Metformin 850mg|All patients receiving Linagliptin 2.5mg and Metformin 850mg.
206608|NCT01540487|P2|Participant Flow|Lina 2.5mg, Metformin 500mg|All patients receiving Linagliptin 2.5mg and Metformin 500mg.
206609|NCT01540487|P1|Participant Flow|Lina 2.5mg, Metformin 850mg|All patients receiving Linagliptin 2.5mg and Metformin 850mg.
206610|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
206611|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
206612|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
206613|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
206614|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
206615|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
206616|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
206617|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
206618|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
206619|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
206620|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
206621|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
206622|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
206623|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
206624|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
206625|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
206626|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
206627|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
206628|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
206629|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
206630|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
206631|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
206632|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
206633|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
206634|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
206635|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
206636|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
206637|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
206638|NCT01540487|E4|Reported Event|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
206639|NCT01540487|E3|Reported Event|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
206640|NCT01540487|E2|Reported Event|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
206641|NCT01540487|E1|Reported Event|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
206642|NCT01540370|B1|Baseline|Patients With OAG and/or OHT|Patients with OAG and/or OHT.
206643|NCT01540370|P1|Participant Flow|Patients With OAG and/or OHT|Patients with OAG and/or OHT.
206644|NCT01540370|O1|Outcome|Patients With OAG and/or OHT|Patients with OAG and/or OHT.
206645|NCT01540370|O1|Outcome|Patients With OAG and/or OHT|Patients with OAG and/or OHT.
206646|NCT01540370|E1|Reported Event|Patients With OAG and/or OHT|Patients with OAG and/or OHT.
206647|NCT01540266|B7|Baseline|Total|Total of all reporting groups
206648|NCT01540266|B6|Baseline|Third Year medical_non-structured|"Third year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
206649|NCT01540266|B5|Baseline|Third Year medical_structured|"Third year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
206650|NCT01540266|B4|Baseline|First Year mediclal_non-structured|"First year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
206651|NCT01540266|B3|Baseline|First Year medical_structured|"First year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
206652|NCT01540266|B2|Baseline|First Year psychology_non-structured|"First year psychology students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
206715|NCT01540045|O2|Outcome|Post-chemotherapy Patientes|Subjective Global Assessment post chemotherapy
206716|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|Subjective Global Assessment pre-chemotherapy
206717|NCT01540045|O2|Outcome|Post-chemotherapy Patients|body mass index post chemotherapy
206653|NCT01540266|B1|Baseline|First Year psychology_structured|"First year psychology students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
206654|NCT01540266|P6|Participant Flow|Third Year medical_non-structured|"Third year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
206655|NCT01540266|P5|Participant Flow|Third Year medical_structured|"Third year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
206656|NCT01540266|P4|Participant Flow|First Year mediclal_non-structured|"First year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
206657|NCT01540266|P3|Participant Flow|First Year medical_structured|"First year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
206658|NCT01540266|P2|Participant Flow|First Year psychology_non-structured|"First year psychology students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
206659|NCT01540266|P1|Participant Flow|First Year psychology_structured|"First year psychology students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
206660|NCT01540266|O6|Outcome|Third Year medical_non-structured|"Third year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
206661|NCT01540266|O5|Outcome|Third Year medical_structured|"Third year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
206662|NCT01540266|O4|Outcome|First Year mediclal_non-structured|"First year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
206663|NCT01540266|O3|Outcome|First Year medical_structured|"First year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
206664|NCT01540266|O2|Outcome|First Year psychology_non-structured|"First year psychology students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
206665|NCT01540266|O1|Outcome|First Year psychology_structured|"First year psychology students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
206666|NCT01540266|E6|Reported Event|Third Year medical_non-structured|"Third year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
206667|NCT01540266|E5|Reported Event|Third Year medical_structured|"Third year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
206668|NCT01540266|E4|Reported Event|First Year mediclal_non-structured|"First year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
206669|NCT01540266|E3|Reported Event|First Year medical_structured|"First year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
206718|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|body mass index pre-chemotherapty
206719|NCT01540045|O2|Outcome|Post-chemotherapy Patients|body composition post chemotherapy
206720|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|body composition pre-chemotherapy
206670|NCT01540266|E2|Reported Event|First Year psychology_non-structured|"First year psychology students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
206671|NCT01540266|E1|Reported Event|First Year psychology_structured|"First year psychology students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
206672|NCT01540162|B3|Baseline|Total|Total of all reporting groups
206673|NCT01540162|B2|Baseline|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
206674|NCT01540162|B1|Baseline|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
206675|NCT01540162|P2|Participant Flow|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
206676|NCT01540162|P1|Participant Flow|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
206677|NCT01540162|O2|Outcome|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
206678|NCT01540162|O1|Outcome|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
206679|NCT01540162|O2|Outcome|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
206680|NCT01540162|O1|Outcome|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
206681|NCT01540162|O2|Outcome|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
206682|NCT01540162|O1|Outcome|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
206683|NCT01540162|E2|Reported Event|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
206684|NCT01540162|E1|Reported Event|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
206685|NCT01540045|B1|Baseline|Pre-chemotherapy Patientes =40|Outpatients from National Cancer Institute with stage III and IV NSCLC candidates for 1 st line chemotherapy paclitaxel-cisplatin based agreeing to participate in the study
206686|NCT01540045|P1|Participant Flow|Pre-chemotherapy Patientes =40|Outpatients from National Cancer Institute with stage III and IV NSCLC candidates for 1 st line chemotherapy paclitaxel-cisplatin based agreeing to participate in the study
206687|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
206688|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
206689|NCT01540045|O2|Outcome|Post-chemotherapy Patients|patients with high or low sensibility to umami, bitter and sweet tastes post-chemotherapy
206690|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|patients with high or low sensibility to umami, bitter and sweet tastes pre-chemotherapy
206691|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
206692|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
206693|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
206694|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
206695|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
206696|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
206697|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
206698|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
206699|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
206700|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
206701|NCT01540045|O2|Outcome|> Umami Recognition Thresholds|quality of life scales in patient with more or the same sensibility to recognize the umami taste
206702|NCT01540045|O1|Outcome|< or = Umami Recognition Thresholds|quality of life scales in patient with more or the same sensibility to recognize the umami taste
206703|NCT01540045|O2|Outcome|< Umami Perception Thresholds|"peripheral neuropathy patients with less sensibility to umami taste pre-post chemotherapy in NSCLC patients.~(< UPT) = less sensibility to umami perception"
206704|NCT01540045|O1|Outcome|> or = Umami Perception Thresholds|"peripheral neuropathy in patients with more or the same sensibility to umami taste pre-post chemotherapy in NSCLC patients.~(> UPT) = more sensibility to umami perception"
206705|NCT01540045|O2|Outcome|< Umami Perception Thresholds|"patients with less sensibility to umami taste pre-post chemotherapy in NSCLC patients.~(< UPT) = less sensibility to umami perception"
206706|NCT01540045|O1|Outcome|> or = Umami Perception Thresholds|"patients with more or the same sensibility to umami taste pre-post chemotherapy in NSCLC patients.~(> UPT) = more sensibility to umami perception"
206707|NCT01540045|O2|Outcome|HRQL Post-chemotherapy|Score of scale HRQL EORTC
206708|NCT01540045|O1|Outcome|HRQL Pre-chemotherapy|Score of scale HRQL EORTC
206709|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
206710|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
206711|NCT01540045|O2|Outcome|< Sweet Perception Thresholds After Chemotherapy|IRON CONSUMPTION < Sweet perception thresholds after chemotherapy
206712|NCT01540045|O1|Outcome|≥ Sweet Perception Thresholds After Chemotherapy|IRON CONSUMPTION ≥ Sweet perception thresholds after chemotherapy
206713|NCT01540045|O2|Outcome|< Sweet Perception Thresholds After Chemotherapy|patient with less sensibility to perceive sweet taste from food
206714|NCT01540045|O1|Outcome|≥ Sweet Perception Thresholds After Chemotherapy|patient with more sensibility to perceive sweet taste from food
206723|NCT01540045|E1|Reported Event|LUNG CANCER PATIENTS|any toxicity resulting from exposure to chemotherapy with which patients are treated are unrelated to this study, which was observational
206724|NCT01539980|B1|Baseline|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
206725|NCT01539980|P1|Participant Flow|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
206726|NCT01539980|O1|Outcome|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
206727|NCT01539980|O1|Outcome|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
206728|NCT01539980|O1|Outcome|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
206729|NCT01539980|O1|Outcome|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
206730|NCT01539980|O1|Outcome|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
206731|NCT01539980|E1|Reported Event|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
206732|NCT01539811|B3|Baseline|Total|Total of all reporting groups
206733|NCT01539811|B2|Baseline|Long Course Antibiotics|"Surgical intervention followed by a long course of antibiotics (>2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Long course antibiotics: Long course (>2 weeks) of antibiotics will be prescribed"
206734|NCT01539811|B1|Baseline|Short Course Antibiotics|"Surgical intervention followed by short course of antibiotics (<2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Short course antibiotics: Short course (<2 weeks) of antibiotics will be prescribed"
206735|NCT01539811|P2|Participant Flow|Long Course Antibiotics|"Surgical intervention followed by a long course of antibiotics (>2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Long course antibiotics: Long course (>2 weeks) of antibiotics will be prescribed"
206736|NCT01539811|P1|Participant Flow|Short Course Antibiotics|"Surgical intervention followed by short course of antibiotics (<2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Short course antibiotics: Short course (<2 weeks) of antibiotics will be prescribed"
206737|NCT01539811|O2|Outcome|Long Course Antibiotics|"Surgical intervention followed by a long course of antibiotics (>2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Long course antibiotics: Long course (>2 weeks) of antibiotics will be prescribed"
206738|NCT01539811|O1|Outcome|Short Course Antibiotics|"Surgical intervention followed by short course of antibiotics (<2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Short course antibiotics: Short course (<2 weeks) of antibiotics will be prescribed"
206739|NCT01539811|E2|Reported Event|Long Course Antibiotics|"Surgical intervention followed by a long course of antibiotics (>2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Long course antibiotics: Long course (>2 weeks) of antibiotics will be prescribed"
206740|NCT01539811|E1|Reported Event|Short Course Antibiotics|"Surgical intervention followed by short course of antibiotics (<2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Short course antibiotics: Short course (<2 weeks) of antibiotics will be prescribed"
206741|NCT01539759|B3|Baseline|Total|Total of all reporting groups
206742|NCT01539759|B2|Baseline|Immediate Postplacental IUD Placement|"Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta~Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta"
206743|NCT01539759|B1|Baseline|Interval IUD Placement|Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
206744|NCT01539759|P2|Participant Flow|Immediate Postplacental IUD Placement|"Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta~Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta"
206745|NCT01539759|P1|Participant Flow|Interval IUD Placement|Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
206746|NCT01539759|O2|Outcome|Immediate Postplacental IUD Placement|"Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta~Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta"
206747|NCT01539759|O1|Outcome|Interval IUD Placement|Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
206748|NCT01539759|O2|Outcome|Immediate Postplacental IUD Placement|"Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta~Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta"
206749|NCT01539759|O1|Outcome|Interval IUD Placement|Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
206750|NCT01539759|O2|Outcome|Immediate Postplacental IUD Placement|"Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta~Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta"
206751|NCT01539759|O1|Outcome|Interval IUD Placement|Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
206752|NCT01539759|E2|Reported Event|Immediate Postplacental IUD Placement|"Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta~Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta"
206753|NCT01539759|E1|Reported Event|Interval IUD Placement|Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
206754|NCT01539642|B3|Baseline|Total|Total of all reporting groups
206755|NCT01539642|B2|Baseline|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
206756|NCT01539642|B1|Baseline|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
206757|NCT01539642|P2|Participant Flow|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
206758|NCT01539642|P1|Participant Flow|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
206759|NCT01539642|O2|Outcome|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
206760|NCT01539642|O1|Outcome|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
206761|NCT01539642|E2|Reported Event|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
206762|NCT01539642|E1|Reported Event|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
206763|NCT01539590|B3|Baseline|Total|Total of all reporting groups
206764|NCT01539590|B2|Baseline|Placebo|Normal saline. Daily intravenous administration for four (4) days.
206765|NCT01539590|B1|Baseline|BB3, 4 Daily Doses|BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days
206766|NCT01539590|P2|Participant Flow|Placebo; 4 Daily Doses|Placebo: Normal saline; Daily intravenous administration for four (4) days. The volume of normal saline will vary by estimated weight.
206767|NCT01539590|P1|Participant Flow|BB3, 4 Daily Doses|BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days ; 10 to 12 minutes; small molecule mimetic of hepatocyte growth factor
206768|NCT01539590|O2|Outcome|Placebo, 4 Daily Doses|Normal saline. Daily intravenous administration for four (4) days.
206769|NCT01539590|O1|Outcome|BB3, 4 Daily Doses|BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days
206770|NCT01539590|E2|Reported Event|Placebo|"Normal saline~Placebo: Daily intravenous administration for four (4) days. The volume of normal saline will vary by estimated weight."
206771|NCT01539590|E1|Reported Event|BB3 Small Molecule Mimetic of Hepatocyte Growth Factor|"small molecule mimetic of hepatocyte growth factor/scatter factor~BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days"
206772|NCT01539538|B3|Baseline|Total|Total of all reporting groups
206773|NCT01539538|B2|Baseline|Morphine IV PCA|
206774|NCT01539538|B1|Baseline|Sufentanil NanoTab PCA System/15 mcg|
206775|NCT01539538|P2|Participant Flow|Morphine IV PCA|
206776|NCT01539538|P1|Participant Flow|Sufentanil NanoTab PCA System/15 mcg|
206777|NCT01539538|O2|Outcome|Morphine IV PCA|
206778|NCT01539538|O1|Outcome|Sufentanil NanoTab PCA System/15 mcg|
206779|NCT01539538|E2|Reported Event|Morphine IV PCA|
206780|NCT01539538|E1|Reported Event|Sufentanil NanoTab PCA System/15 mcg|
206781|NCT01539525|B4|Baseline|Total|Total of all reporting groups
207174|NCT01537120|E1|Reported Event|Vildagliptin 50 mg|Vildagliptin tablets 50 mg twice daily for 12 weeks
206782|NCT01539525|B3|Baseline|Treatment as Usual|"No intervention- resource list provided.~Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area."
206783|NCT01539525|B2|Baseline|Motivational Interview-Electronic|"Motivational Interview provided by an interactive computer program.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
206784|NCT01539525|B1|Baseline|Motivational Interview|"Motivational interview provided by a clinical research nurse or physician.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
206785|NCT01539525|P3|Participant Flow|Treatment as Usual|"No intervention- resource list provided.~Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area."
206786|NCT01539525|P2|Participant Flow|Motivational Interview-Computer|"Motivational Interview provided by an interactive computer program.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
206787|NCT01539525|P1|Participant Flow|Motivational Interview-Nurse|"Motivational interview provided by a clinical research nurse or physician.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
206788|NCT01539525|O3|Outcome|Treatment as Usual|"No intervention- resource list provided.~Treatment as Usual: Subjects given a brochure listing relevant recovery resources in the local area."
206789|NCT01539525|O2|Outcome|Motivational Interview-Electronic|"Motivational Interview provided by an interactive computer program.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
206790|NCT01539525|O1|Outcome|Motivational Interview|"Motivational interview provided by a clinical research nurse or physician.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
206791|NCT01539525|O3|Outcome|Treatment as Usual|"No intervention- resource list provided.~Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area."
206792|NCT01539525|O2|Outcome|Motivational Interview-Computer|"Motivational Interview provided by an interactive computer program.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
206793|NCT01539525|O1|Outcome|Motivational Interview-Nurse|"Motivational interview provided by a clinical research nurse or physician.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
206794|NCT01539525|O3|Outcome|Treatment as Usual|"No intervention- resource list provided.~Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area."
206795|NCT01539525|O2|Outcome|Motivational Interview-Computer|"Motivational Interview provided by an interactive computer program.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
206796|NCT01539525|O1|Outcome|Motivational Interview-Nurse|"Motivational interview provided by a clinical research nurse or physician.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
206797|NCT01539525|O3|Outcome|Treatment as Usual|"No intervention- resource list provided.~Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area."
206798|NCT01539525|O2|Outcome|Motivational Interview-Computer|"Motivational Interview provided by an interactive computer program.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
206799|NCT01539525|O1|Outcome|Motivational Interview-Nurse|"Motivational interview provided by a clinical research nurse or physician.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
206800|NCT01539525|E3|Reported Event|Treatment as Usual|"No intervention- resource list provided.~Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area."
206801|NCT01539525|E2|Reported Event|Motivational Interview-Electronic|"Motivational Interview provided by an interactive computer program.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
206802|NCT01539525|E1|Reported Event|Motivational Interview|"Motivational interview provided by a clinical research nurse or physician.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
206803|NCT01539512|B3|Baseline|Total|Total of all reporting groups
206804|NCT01539512|B2|Baseline|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
206805|NCT01539512|B1|Baseline|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
206806|NCT01539512|P2|Participant Flow|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
206807|NCT01539512|P1|Participant Flow|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
206808|NCT01539512|O2|Outcome|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
206809|NCT01539512|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
206810|NCT01539512|O2|Outcome|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
206811|NCT01539512|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
206812|NCT01539512|O2|Outcome|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
206813|NCT01539512|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
206814|NCT01539512|O2|Outcome|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
206815|NCT01539512|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
206816|NCT01539512|O2|Outcome|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
206817|NCT01539512|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
206818|NCT01539512|E2|Reported Event|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
206819|NCT01539512|E1|Reported Event|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
206820|NCT01539317|B3|Baseline|Total|Total of all reporting groups
206821|NCT01539317|B2|Baseline|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
206822|NCT01539317|B1|Baseline|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
206823|NCT01539317|P2|Participant Flow|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
206824|NCT01539317|P1|Participant Flow|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
206825|NCT01539317|O2|Outcome|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
206826|NCT01539317|O1|Outcome|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
206827|NCT01539317|O2|Outcome|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
206828|NCT01539317|O1|Outcome|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
206829|NCT01539317|O2|Outcome|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
206830|NCT01539317|O1|Outcome|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
206831|NCT01539317|O2|Outcome|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
206832|NCT01539317|O1|Outcome|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
206833|NCT01539317|O3|Outcome|Open Label|"During Open-label Lidocaine 8 weeks~Each prior arm converted to use of open label lidocaine for 2 further months."
206834|NCT01539317|O2|Outcome|Topical Liquid Lidocaine|"Topical liquid lidocaine: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule~Topical saline: saline applied to the vestibule mucosa will not reverse the local tenderness"
206835|NCT01539317|O1|Outcome|Topical Saline|"Topical liquid lidocaine: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule~Topical saline: saline applied to the vestibule mucosa will not reverse the local tenderness"
206836|NCT01539317|E2|Reported Event|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
206837|NCT01539317|E1|Reported Event|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
206838|NCT01539135|B3|Baseline|Total|Total of all reporting groups
206839|NCT01539135|B2|Baseline|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
206840|NCT01539135|B1|Baseline|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
206841|NCT01539135|P2|Participant Flow|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
206842|NCT01539135|P1|Participant Flow|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
206843|NCT01539135|O2|Outcome|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
206844|NCT01539135|O1|Outcome|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
206845|NCT01539135|O2|Outcome|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
206846|NCT01539135|O1|Outcome|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
206847|NCT01539135|O2|Outcome|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
206848|NCT01539135|O1|Outcome|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
206849|NCT01539135|O2|Outcome|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
206850|NCT01539135|O1|Outcome|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
206851|NCT01539135|E2|Reported Event|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
206852|NCT01539135|E1|Reported Event|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
206853|NCT01539083|B1|Baseline|Bortezomib + Cyclophosphamide + Dexamethasone [VCD Induction]|Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m^2 orally on Days 1, 8, and 15; and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.
206854|NCT01539083|P3|Participant Flow|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
206855|NCT01539083|P2|Participant Flow|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
206856|NCT01539083|P1|Participant Flow|Bortezomib + Cyclophosphamide + Dexamethasone [VCD Induction]|Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m^2 orally on Days 1, 8, and 15; and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.
206857|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
206858|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
206859|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
206860|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
206861|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
206862|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
206863|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
206864|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
206865|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
206866|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
206867|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
206868|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
206869|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
206870|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
206871|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
206872|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
206873|NCT01539083|E3|Reported Event|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
206874|NCT01539083|E2|Reported Event|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
206875|NCT01539083|E1|Reported Event|Bortezomib + Cyclophosphamide + Dexamethasone [VCD Induction]|Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m^2 orally on Days 1, 8, and 15; and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.
206876|NCT01539070|B3|Baseline|Total|Total of all reporting groups
206877|NCT01539070|B2|Baseline|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
206878|NCT01539070|B1|Baseline|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.~There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
206879|NCT01539070|P2|Participant Flow|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
206880|NCT01539070|P1|Participant Flow|Eating and Physical Activity Counseling|"Eating and physical activity counseling: The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.~There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
206881|NCT01539070|O2|Outcome|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
206899|NCT01538719|B1|Baseline|Placebo|"2:1 randomization~Placebo: Patients randomized to placebo will receive saline subcutaneously (SQ) on day 0 and each week for 5 additional weeks"
206900|NCT01538719|P2|Participant Flow|Rilonacept|"2:1 randomization~Rilonacept: Patients randomized to active study drug will receive Rilonacept 320 mg subcutaneously (SQ) on day 0 and 160 mg SQ each week for 5 additional weeks"
206901|NCT01538719|P1|Participant Flow|Placebo|"2:1 randomization~Placebo: Patients randomized to placebo will receive saline subcutaneously (SQ) on day 0 and each week for 5 additional weeks"
206882|NCT01539070|O1|Outcome|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.~There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
206883|NCT01539070|O2|Outcome|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
206884|NCT01539070|O1|Outcome|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.~There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
206885|NCT01539070|O2|Outcome|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
206886|NCT01539070|O1|Outcome|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.~There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
206887|NCT01539070|O2|Outcome|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
206888|NCT01539070|O1|Outcome|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.~There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
206889|NCT01539070|E2|Reported Event|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
206890|NCT01539070|E1|Reported Event|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.~There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
206891|NCT01538862|B1|Baseline|Granulocyte Colony Stimulating Factor (GCSF)|"GCSF 10mcg/kg/d SQ for 7 days~Granulocyte Colony Stimulating Factor (GCSF): G-CSF 10mcg/kg/d SQ for 7 days"
206892|NCT01538862|P1|Participant Flow|Granulocyte Colony Stimulating Factor (GCSF)|"GCSF 10mcg/kg/d SQ for 7 days~Granulocyte Colony Stimulating Factor (GCSF): G-CSF 10mcg/kg/d SQ for 7 days"
206893|NCT01538862|O1|Outcome|Granulocyte Colony Stimulating Factor (GCSF)|"GCSF 10mcg/kg/d SQ for 7 days~Granulocyte Colony Stimulating Factor (GCSF): G-CSF 10mcg/kg/d SQ for 7 days"
206894|NCT01538862|O1|Outcome|Granulocyte Colony Stimulating Factor (GCSF)|"GCSF 10mcg/kg/d subcutaneously for 7 days~Granulocyte Colony Stimulating Factor (GCSF): G-CSF 10mcg/kg/d subcutaneously for 7 days"
206895|NCT01538862|O1|Outcome|Granulocyte Colony Stimulating Factor (GCSF)|"GCSF 10mcg/kg/d subcutaneously for 7 days~Granulocyte Colony Stimulating Factor (GCSF): G-CSF 10mcg/kg/d subcutaneously for 7 days"
206896|NCT01538862|E1|Reported Event|Granulocyte Colony Stimulating Factor (GCSF)|"GCSF 10mcg/kg/d SQ for 7 days~Granulocyte Colony Stimulating Factor (GCSF): G-CSF 10mcg/kg/d SQ for 7 days"
206897|NCT01538719|B3|Baseline|Total|Total of all reporting groups
206898|NCT01538719|B2|Baseline|Rilonacept|"2:1 randomization~Rilonacept: Patients randomized to active study drug will receive Rilonacept 320 mg subcutaneously (SQ) on day 0 and 160 mg SQ each week for 5 additional weeks"
206902|NCT01538719|O2|Outcome|Rilonacept|"2:1 randomization~Rilonacept: Patients randomized to active study drug will receive Rilonacept 320 mg subcutaneously (SQ) on day 0 and 160 mg SQ each week for 5 additional weeks"
206903|NCT01538719|O1|Outcome|Placebo|"2:1 randomization~Placebo: Patients randomized to placebo will receive saline subcutaneously (SQ) on day 0 and each week for 5 additional weeks"
206904|NCT01538719|O2|Outcome|Rilonacept|"2:1 randomization~Rilonacept: Patients randomized to active study drug will receive Rilonacept 320 mg subcutaneously (SQ) on day 0 and 160 mg SQ each week for 5 additional weeks"
206905|NCT01538719|O1|Outcome|Placebo|"2:1 randomization~Placebo: Patients randomized to placebo will receive saline subcutaneously (SQ) on day 0 and each week for 5 additional weeks"
206906|NCT01538719|E2|Reported Event|Rilonacept|"2:1 randomization~Rilonacept: Patients randomized to active study drug will receive Rilonacept 320 mg subcutaneously (SQ) on day 0 and 160 mg SQ each week for 5 additional weeks"
206907|NCT01538719|E1|Reported Event|Placebo|"2:1 randomization~Placebo: Patients randomized to placebo will receive saline subcutaneously (SQ) on day 0 and each week for 5 additional weeks"
206908|NCT01538615|B3|Baseline|Total|Total of all reporting groups
206909|NCT01538615|B2|Baseline|Control|Control participants receive a monthly newsletter for the 10 months of the study with tips on healthy eating. The topics do not overlap the intervention content.
206910|NCT01538615|B1|Baseline|HOME Plus Intervention|HOME Plus intervention: The HOME Plus program families will participate in monthly, two-hour group sessions for ten months at local community centers. Each session offers new ideas focusing on family meals, healthy eating, and reducing sedentary behavior. At each session, families prepare and eat a meal together and participate in small group discussions and activities for both parent and child groups to promote healthy behaviors in the home. Topics include planning healthy meals and snacks with your family, having meals with your family more often, and improving the healthfulness of the food available at home. Families also receive periodic supportive phone calls throughout the year using motivational interviewing techniques to promote healthy behaviors to prevent and reduce childhood obesity.
206911|NCT01538615|P2|Participant Flow|Control|Control participants receive a monthly newsletter for the 10 months of the study with tips on healthy eating. The topics do not overlap the intervention content.
206912|NCT01538615|P1|Participant Flow|HOME Plus Intervention|HOME Plus intervention: The HOME Plus program families will participate in monthly, two-hour group sessions for ten months at local community centers. Each session offers new ideas focusing on family meals, healthy eating, and reducing sedentary behavior. At each session, families prepare and eat a meal together and participate in small group discussions and activities for both parent and child groups to promote healthy behaviors in the home. Topics include planning healthy meals and snacks with your family, having meals with your family more often, and improving the healthfulness of the food available at home. Families also receive periodic supportive phone calls throughout the year using motivational interviewing techniques to promote healthy behaviors to prevent and reduce childhood obesity.
206913|NCT01538615|O2|Outcome|Control|Control participants receive a monthly newsletter for the 10 months of the study with tips on healthy eating. The topics do not overlap the intervention content.
206914|NCT01538615|O1|Outcome|HOME Plus Intervention|HOME Plus intervention: The HOME Plus program families will participate in monthly, two-hour group sessions for ten months at local community centers. Each session offers new ideas focusing on family meals, healthy eating, and reducing sedentary behavior. At each session, families prepare and eat a meal together and participate in small group discussions and activities for both parent and child groups to promote healthy behaviors in the home. Topics include planning healthy meals and snacks with your family, having meals with your family more often, and improving the healthfulness of the food available at home. Families also receive periodic supportive phone calls throughout the year using motivational interviewing techniques to promote healthy behaviors to prevent and reduce childhood obesity.
206915|NCT01538615|O2|Outcome|Control|Control participants receive a monthly newsletter for the 10 months of the study with tips on healthy eating. The topics do not overlap the intervention content.
206916|NCT01538615|O1|Outcome|HOME Plus Intervention|HOME Plus intervention: The HOME Plus program families will participate in monthly, two-hour group sessions for ten months at local community centers. Each session offers new ideas focusing on family meals, healthy eating, and reducing sedentary behavior. At each session, families prepare and eat a meal together and participate in small group discussions and activities for both parent and child groups to promote healthy behaviors in the home. Topics include planning healthy meals and snacks with your family, having meals with your family more often, and improving the healthfulness of the food available at home. Families also receive periodic supportive phone calls throughout the year using motivational interviewing techniques to promote healthy behaviors to prevent and reduce childhood obesity.
206917|NCT01538615|O2|Outcome|Control|Control participants receive a monthly newsletter for the 10 months of the study with tips on healthy eating. The topics do not overlap the intervention content.
206918|NCT01538615|O1|Outcome|HOME Plus Intervention|HOME Plus intervention: The HOME Plus program families will participate in monthly, two-hour group sessions for ten months at local community centers. Each session offers new ideas focusing on family meals, healthy eating, and reducing sedentary behavior. At each session, families prepare and eat a meal together and participate in small group discussions and activities for both parent and child groups to promote healthy behaviors in the home. Topics include planning healthy meals and snacks with your family, having meals with your family more often, and improving the healthfulness of the food available at home. Families also receive periodic supportive phone calls throughout the year using motivational interviewing techniques to promote healthy behaviors to prevent and reduce childhood obesity.
206919|NCT01538615|O2|Outcome|Control|Control participants receive a monthly newsletter for the 10 months of the study with tips on healthy eating. The topics do not overlap the intervention content.
206948|NCT01538199|O3|Outcome|Pilot Study Treatment Group 1|"The TLT group will receive 2 TLT treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 sham treatments per week for 3 weeks.~1 participant was missing a final visit 8 value, so LOCF was used for this value.~(see protocol change 10/28/2014)"
206949|NCT01538199|O2|Outcome|TLT Treatment Group 2 (Placebo)|"The sham group will receive 2 treatments of the sham device per week for 8 weeks~Sham device: The sham device does not emit near-infrared radiation."
207175|NCT01537081|B4|Baseline|Total|Total of all reporting groups
206920|NCT01538615|O1|Outcome|HOME Plus Intervention|HOME Plus intervention: The HOME Plus program families will participate in monthly, two-hour group sessions for ten months at local community centers. Each session offers new ideas focusing on family meals, healthy eating, and reducing sedentary behavior. At each session, families prepare and eat a meal together and participate in small group discussions and activities for both parent and child groups to promote healthy behaviors in the home. Topics include planning healthy meals and snacks with your family, having meals with your family more often, and improving the healthfulness of the food available at home. Families also receive periodic supportive phone calls throughout the year using motivational interviewing techniques to promote healthy behaviors to prevent and reduce childhood obesity.
206921|NCT01538615|E2|Reported Event|Control|Control participants receive a monthly newsletter for the 10 months of the study with tips on healthy eating. The topics do not overlap the intervention content.
206922|NCT01538615|E1|Reported Event|HOME Plus Intervention|HOME Plus intervention: The HOME Plus program families will participate in monthly, two-hour group sessions for ten months at local community centers. Each session offers new ideas focusing on family meals, healthy eating, and reducing sedentary behavior. At each session, families prepare and eat a meal together and participate in small group discussions and activities for both parent and child groups to promote healthy behaviors in the home. Topics include planning healthy meals and snacks with your family, having meals with your family more often, and improving the healthfulness of the food available at home. Families also receive periodic supportive phone calls throughout the year using motivational interviewing techniques to promote healthy behaviors to prevent and reduce childhood obesity.
206923|NCT01538472|B1|Baseline|Y Zevalin + BEAM|Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with BCNU (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.
206924|NCT01538472|P1|Participant Flow|Y Zevalin + BEAM|Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with 1,3-bis(2-chloroethyl)-1-nitrosourea bis-chloronitrosourea (BCNU) (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.
206925|NCT01538472|O1|Outcome|Y Zevalin + BEAM|Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with BCNU (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.
206926|NCT01538472|O1|Outcome|Y Zevalin + BEAM|Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with BCNU (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.
206927|NCT01538472|E1|Reported Event|Y Zevalin + BEAM|Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with BCNU (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.
206928|NCT01538199|B7|Baseline|Total|Total of all reporting groups
206929|NCT01538199|B6|Baseline|Pilot Study Screen Fail/Not Randomized|"10 participants screen failed (5 had HAM-D scores that were above threshold for study inclusion criteria, 1 had too many failed trials in the current depressive episode, 1 had active substance abuse, 2 did not meet criteria for Major Depressive Disorder at the time of the screening visit, 1 had just started psychotherapy at the time of the screen). 1 participant dropped out pre-randomization due to time constraints.~(see protocol change 10/28/2014)"
206930|NCT01538199|B5|Baseline|Pilot Study Treatment Group 2|"The sham group will receive 2 sham treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 TLT treatments per week for 3 weeks.~(see protocol change 10/28/2014)"
206931|NCT01538199|B4|Baseline|Pilot Study Treatment Group 1|"The TLT group will receive 2 TLT treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 sham treatments per week for 3 weeks.~(see protocol change 10/28/2014)"
206932|NCT01538199|B3|Baseline|Screen Fail/Not Randomized|9 participants screen failed (3 had HAM-D scores that were below the threshold for study inclusion, 2 had bipolar disorder, 1 had active substance abuse, 1 had an exclusionary comorbid medical disorder, 1 did not pass drug screen, 1 was not depressed) . 5 participants decided not to participate after the screen (1 due to time commitment, 2 were no longer interested, 1 was moving away, and 1 was lost to follow up). 1 was discontinued by investigator pre randomization at Visit 1 because it was discovered at Visit 1 that the patient's primary diagnosis was PTSD (MDD was secondary). Additionally, the patient's trauma symptoms significantly interfered with their ability to complete the study tasks.
206933|NCT01538199|B2|Baseline|TLT Treatment Group 2|"The sham group will receive 2 treatments of the sham device per week for 8 weeks~Sham device: The sham device does not emit near-infrared radiation."
206972|NCT01537835|B3|Baseline|Antimicrobial Scrubs 2|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
206934|NCT01538199|B1|Baseline|TLT Treatment Group 1|"The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks~Near-infrared radiation via Transcranial LED Therapy: The subject will lie down comfortably on a exam bed . The sites of application of TLT (left and right forehead) will be inspected for any skin lesions (e.g. laceration or signs of inflammation) which would contraindicate the treatment. The subject will wear protective eyewear in the form of goggles or eye pads.~The staff administering the TLT will be careful not to shine the light in or near the eyes of the subject. The two OLS devices will be secured in position with the use of a Hair Net. The delivery of the TLT is expected to last 20 min total (simultaneous application on the left and right forehead). The subject will be asked to rest for five minutes after the delivery of TLT. The skin at the sites of the application will be inspected again prior to dismissing the subject."
206935|NCT01538199|P4|Participant Flow|Pilot Study Treatment Group 2|"The sham group will receive 2 sham treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 TLT treatments per week for 3 weeks.~(see protocol change 10/28/2014)"
206936|NCT01538199|P3|Participant Flow|Pilot Study Treatment Group 1|"The TLT group will receive 2 TLT treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 sham treatments per week for 3 weeks.~(see protocol change 10/28/2014)"
206937|NCT01538199|P2|Participant Flow|TLT Treatment Group 2 (Placebo)|"The sham group will receive 2 treatments of the sham device per week for 8 weeks~Sham device: The sham device does not emit near-infrared radiation."
206938|NCT01538199|P1|Participant Flow|TLT Treatment Group 1 (Active TLT Treatment)|"The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks~Near-infrared radiation via Transcranial LED Therapy: The subject will lie down comfortably on a exam bed . The sites of application of TLT (left and right forehead) will be inspected for any skin lesions (e.g. laceration or signs of inflammation) which would contraindicate the treatment. The subject will wear protective eyewear in the form of goggles or eye pads.~The staff administering the TLT will be careful not to shine the light in or near the eyes of the subject. The two OLS devices will be secured in position with the use of a Hair Net. The delivery of the TLT is expected to last 20 min total (simultaneous application on the left and right forehead). The subject will be asked to rest for five minutes after the delivery of TLT. The skin at the sites of the application will be inspected again prior to dismissing the subject."
206939|NCT01538199|O5|Outcome|Pilot Study Treatment Group 1|"The TLT group will receive 2 TLT treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 sham treatments per week for 3 weeks.~(see protocol change 10/28/2014)"
206940|NCT01538199|O4|Outcome|TLT Treatment Group 2 (Placebo) Completers|"The sham group will receive 2 treatments of the sham device per week for 8 weeks. This only includes those who were followed for the entire 8-week study period and who received a clinical assessment immediately after.~Sham device: The sham device does not emit near-infrared radiation."
206941|NCT01538199|O3|Outcome|TLT Treatment Group 1 (Active TLT Treatment) Completers|"The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks (completers only).~Near-infrared radiation via Transcranial LED Therapy: The subject will lie down comfortably on a exam bed . The sites of application of TLT (left and right forehead) will be inspected for any skin lesions (e.g. laceration or signs of inflammation) which would contraindicate the treatment. The subject will wear protective eyewear in the form of goggles or eye pads.~The staff administering the TLT will be careful not to shine the light in or near the eyes of the subject. The two OLS devices will be secured in position with the use of a Hair Net. The delivery of the TLT is expected to last 20 min total (simultaneous application on the left and right forehead). The subject will be asked to rest for five minutes after the delivery of TLT. The skin at the sites of the application will be inspected again prior to dismissing the subject."
206942|NCT01538199|O2|Outcome|TLT Treatment Group 2 (Placebo)|"The sham group will receive 2 treatments of the sham device per week for 8 weeks~Sham device: The sham device does not emit near-infrared radiation."
206943|NCT01538199|O1|Outcome|TLT Treatment Group 1 (Active TLT Treatment)|"The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks~Near-infrared radiation via Transcranial LED Therapy: The subject will lie down comfortably on a exam bed . The sites of application of TLT (left and right forehead) will be inspected for any skin lesions (e.g. laceration or signs of inflammation) which would contraindicate the treatment. The subject will wear protective eyewear in the form of goggles or eye pads.~The staff administering the TLT will be careful not to shine the light in or near the eyes of the subject. The two OLS devices will be secured in position with the use of a Hair Net. The delivery of the TLT is expected to last 20 min total (simultaneous application on the left and right forehead). The subject will be asked to rest for five minutes after the delivery of TLT. The skin at the sites of the application will be inspected again prior to dismissing the subject."
206944|NCT01538199|O4|Outcome|Pilot Study Treatment Group 2|"The sham group will receive 2 sham treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 TLT treatments per week for 3 weeks.~(see protocol change 10/28/2014)"
206945|NCT01538199|O3|Outcome|Pilot Study Treatment Group 1|"The TLT group will receive 2 TLT treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 sham treatments per week for 3 weeks.~(see protocol change 10/28/2014)"
206946|NCT01538199|O2|Outcome|TLT Treatment Group 2|"The sham group will receive 2 treatments of the sham device per week for 8 weeks~Sham device: The sham device does not emit near-infrared radiation."
206947|NCT01538199|O1|Outcome|TLT Treatment Group 1|"The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks~Near-infrared radiation via Transcranial LED Therapy: The subject will lie down comfortably on a exam bed . The sites of application of TLT (left and right forehead) will be inspected for any skin lesions (e.g. laceration or signs of inflammation) which would contraindicate the treatment. The subject will wear protective eyewear in the form of goggles or eye pads.~The staff administering the TLT will be careful not to shine the light in or near the eyes of the subject. The two OLS devices will be secured in position with the use of a Hair Net. The delivery of the TLT is expected to last 20 min total (simultaneous application on the left and right forehead). The subject will be asked to rest for five minutes after the delivery of TLT. The skin at the sites of the application will be inspected again prior to dismissing the subject."
206950|NCT01538199|O1|Outcome|TLT Treatment Group 1 (Active TLT Treatment)|"The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks~Near-infrared radiation via Transcranial LED Therapy: The subject will lie down comfortably on a exam bed . The sites of application of TLT (left and right forehead) will be inspected for any skin lesions (e.g. laceration or signs of inflammation) which would contraindicate the treatment. The subject will wear protective eyewear in the form of goggles or eye pads.~The staff administering the TLT will be careful not to shine the light in or near the eyes of the subject. The two OLS devices will be secured in position with the use of a Hair Net. The delivery of the TLT is expected to last 20 min total (simultaneous application on the left and right forehead). The subject will be asked to rest for five minutes after the delivery of TLT. The skin at the sites of the application will be inspected again prior to dismissing the subject."
206951|NCT01538199|O5|Outcome|Pilot Study Treatment Group 1|"The TLT group will receive 2 TLT treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 sham treatments per week for 3 weeks.~1 participant was missing a final visit 8 value, so LOCF was used for this value.~(see protocol change 10/28/2014)"
206952|NCT01538199|O4|Outcome|TLT Treatment Group 2 (Placebo) Completers|"The sham group will receive 2 treatments of the sham device per week for 8 weeks. This only includes those who were followed for the entire 8-week study period and who received a clinical assessment immediately after.~Sham device: The sham device does not emit near-infrared radiation."
206953|NCT01538199|O3|Outcome|TLT Treatment Group 1 (Active TLT Treatment) Completers|"The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks (completers only).~Near-infrared radiation via Transcranial LED Therapy: The subject will lie down comfortably on a exam bed . The sites of application of TLT (left and right forehead) will be inspected for any skin lesions (e.g. laceration or signs of inflammation) which would contraindicate the treatment. The subject will wear protective eyewear in the form of goggles or eye pads.~The staff administering the TLT will be careful not to shine the light in or near the eyes of the subject. The two OLS devices will be secured in position with the use of a Hair Net. The delivery of the TLT is expected to last 20 min total (simultaneous application on the left and right forehead). The subject will be asked to rest for five minutes after the delivery of TLT. The skin at the sites of the application will be inspected again prior to dismissing the subject."
206954|NCT01538199|O2|Outcome|TLT Treatment Group 2 (Placebo)|"The sham group will receive 2 treatments of the sham device per week for 8 weeks~Sham device: The sham device does not emit near-infrared radiation."
206955|NCT01538199|O1|Outcome|TLT Treatment Group 1 (Active TLT Treatment)|"The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks~Near-infrared radiation via Transcranial LED Therapy: The subject will lie down comfortably on a exam bed . The sites of application of TLT (left and right forehead) will be inspected for any skin lesions (e.g. laceration or signs of inflammation) which would contraindicate the treatment. The subject will wear protective eyewear in the form of goggles or eye pads.~The staff administering the TLT will be careful not to shine the light in or near the eyes of the subject. The two OLS devices will be secured in position with the use of a Hair Net. The delivery of the TLT is expected to last 20 min total (simultaneous application on the left and right forehead). The subject will be asked to rest for five minutes after the delivery of TLT. The skin at the sites of the application will be inspected again prior to dismissing the subject."
206956|NCT01538199|E4|Reported Event|Pilot Study Treatment Group 2|"The sham group will receive 2 sham treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 TLT treatments per week for 3 weeks.~(see protocol change 10/28/2014)"
206957|NCT01538199|E3|Reported Event|Pilot Study Treatment Group 1|"The TLT group will receive 2 TLT treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 sham treatments per week for 3 weeks.~(see protocol change 10/28/2014)"
206958|NCT01538199|E2|Reported Event|TLT Treatment Group 2|"The sham group will receive 2 treatments of the sham device per week for 8 weeks~Sham device: The sham device does not emit near-infrared radiation."
206959|NCT01538199|E1|Reported Event|TLT Treatment Group 1|"The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks~Near-infrared radiation via Transcranial LED Therapy: The subject will lie down comfortably on a exam bed . The sites of application of TLT (left and right forehead) will be inspected for any skin lesions (e.g. laceration or signs of inflammation) which would contraindicate the treatment. The subject will wear protective eyewear in the form of goggles or eye pads.~The staff administering the TLT will be careful not to shine the light in or near the eyes of the subject. The two OLS devices will be secured in position with the use of a Hair Net. The delivery of the TLT is expected to last 20 min total (simultaneous application on the left and right forehead). The subject will be asked to rest for five minutes after the delivery of TLT. The skin at the sites of the application will be inspected again prior to dismissing the subject."
206960|NCT01537900|B1|Baseline|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
206961|NCT01537900|P1|Participant Flow|Grazoprevir 100 mg|Participants received GZR 100 mg once daily (q.d.) for 7 days. Liver FNA was performed on Day 7.
206962|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
206963|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
206964|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
206965|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
206966|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
206967|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
206968|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
206969|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
206970|NCT01537900|E1|Reported Event|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
206971|NCT01537835|B4|Baseline|Total|Total of all reporting groups
206973|NCT01537835|B2|Baseline|Antimicrobial Scrubs 1|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
206974|NCT01537835|B1|Baseline|Standard Scrubs|Participants will be randomized to one of three types of uniforms. This arm is the standard scrub arm. The participants will wear new standard scrubs.
206975|NCT01537835|P3|Participant Flow|Antimicrobial Scrubs 2|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
206976|NCT01537835|P2|Participant Flow|Antimicrobial Scrubs 1|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
206977|NCT01537835|P1|Participant Flow|Standard Scrubs|Participants will be randomized to one of three types of uniforms. This arm is the standard scrub arm. The participants will wear new standard scrubs.
206978|NCT01537835|O3|Outcome|Antimicrobial Scrubs 2|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
206979|NCT01537835|O2|Outcome|Antimicrobial Scrubs 1|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
206980|NCT01537835|O1|Outcome|Standard Scrubs|Participants will be randomized to one of three types of uniforms. This arm is the standard scrub arm. The participants will wear new standard scrubs.
206981|NCT01537835|O3|Outcome|Antimicrobial Scrubs 2|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
206982|NCT01537835|O2|Outcome|Antimicrobial Scrubs 1|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
206983|NCT01537835|O1|Outcome|Standard Scrubs|Participants will be randomized to one of three types of uniforms. This arm is the standard scrub arm. The participants will wear new standard scrubs.
206984|NCT01537835|E3|Reported Event|Antimicrobial Scrubs 2|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
206985|NCT01537835|E2|Reported Event|Antimicrobial Scrubs 1|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
206986|NCT01537835|E1|Reported Event|Standard Scrubs|Participants will be randomized to one of three types of uniforms. This arm is the standard scrub arm. The participants will wear new standard scrubs.
206987|NCT01537783|B3|Baseline|Total|Total of all reporting groups
206988|NCT01537783|B2|Baseline|Standard of Care|Standard emergency department care
206989|NCT01537783|B1|Baseline|Intervention Group|Standard emergency department care plus eradication protocol
206990|NCT01537783|P2|Participant Flow|Intervention|Usual emergency department care plus eradication protocol
206991|NCT01537783|P1|Participant Flow|Standard of Care|Usual emergency department care
206992|NCT01537783|O2|Outcome|Standard of Care|In this arm, patients receive routine care of their abscess, which may or may not include either topical or oral antibiotics, at the discretion of the treating clinician.
206993|NCT01537783|O1|Outcome|Intervention Group|"In this arm, patients are treated with chlorhexidine scrubs once a day for 5 days and mupirocin nasal ointment inserted to both nostrils twice a day for 5 days. Both treatments are begun 7 days after enrollment, or when the abscess has healed fully if it has not healed by day 7.~Chlorhexidine gluconate: Scrubs applied once a day for 5 days~Mupirocin: Nasal mupirocin applied topically to both nostrils twice a day for 5 days"
206994|NCT01537783|E2|Reported Event|Standard of Care|Standard emergency department care
206995|NCT01537783|E1|Reported Event|Intervention Group|Standard emergency department care plus eradication protocol
206996|NCT01537666|B5|Baseline|Total|Total of all reporting groups
206997|NCT01537666|B4|Baseline|AeroVanc 32 and 80 mg in CF Patients|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
207202|NCT01537068|E2|Reported Event|Placebo|"Placebo treatment~Placebo: Matching placebo pills"
206998|NCT01537666|B3|Baseline|AeroVanc 80 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
206999|NCT01537666|B2|Baseline|AeroVanc 32 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
207000|NCT01537666|B1|Baseline|Aerovanc 16 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
207001|NCT01537666|P4|Participant Flow|AeroVanc 32 and 80 mg in CF Patients|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
207002|NCT01537666|P3|Participant Flow|AeroVanc 80 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
207003|NCT01537666|P2|Participant Flow|AeroVanc 32 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
207004|NCT01537666|P1|Participant Flow|Aerovanc 16 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
207005|NCT01537666|O2|Outcome|AeroVanc 80 mg in Cystic Fibrosis Patients|Single inhaled dose of 80 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
207006|NCT01537666|O1|Outcome|AeroVanc 32 mg in Cystic Fibrosis Patients|Single inhaled dose of 32 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
207007|NCT01537666|O2|Outcome|AeroVanc 80 mg in Cystic Fibrosis Patients|Single inhaled dose of 80 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
207008|NCT01537666|O1|Outcome|AeroVanc 32 mg in Cystic Fibrosis Patients|Single inhaled dose of 32 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
207009|NCT01537666|O4|Outcome|IV Vancomycin 250 mg in Healthy Volunteers|IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration
207010|NCT01537666|O3|Outcome|AeroVanc 80 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
207011|NCT01537666|O2|Outcome|AeroVanc 32 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
207012|NCT01537666|O1|Outcome|Aerovanc 16 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
207013|NCT01537666|O4|Outcome|IV Vancomycin 250 mg in Healthy Volunteers|IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration
207014|NCT01537666|O3|Outcome|AeroVanc 80 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
207015|NCT01537666|O2|Outcome|AeroVanc 32 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
207016|NCT01537666|O1|Outcome|Aerovanc 16 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
207017|NCT01537666|O4|Outcome|IV Vancomycin 250 mg in Healthy Volunteers|IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration
207018|NCT01537666|O3|Outcome|AeroVanc 80 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
207019|NCT01537666|O2|Outcome|AeroVanc 32 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
207020|NCT01537666|O1|Outcome|Aerovanc 16 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
207021|NCT01537666|O4|Outcome|IV Vancomycin 250 mg in Healthy Volunteers|IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration
207022|NCT01537666|O3|Outcome|AeroVanc 80 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
207023|NCT01537666|O2|Outcome|AeroVanc 32 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
207024|NCT01537666|O1|Outcome|Aerovanc 16 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
207025|NCT01537666|O4|Outcome|IV Vancomycin 250 mg in Healthy Volunteers|IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration
207026|NCT01537666|O3|Outcome|AeroVanc 80 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
207027|NCT01537666|O2|Outcome|AeroVanc 32 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
207028|NCT01537666|O1|Outcome|Aerovanc 16 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
207029|NCT01537666|O6|Outcome|AeroVanc 80 mg in Cystic Fibrosis Patients|Single inhaled dose of 80 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
207030|NCT01537666|O5|Outcome|AeroVanc 32 mg in Cystic Fibrosis Patients|Single inhaled dose of 32 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
207031|NCT01537666|O4|Outcome|IV Vancomycin 250 mg in Healthy Volunteers|Single IV dose of Vancomycin 250 mg in Healthy Volunteers. Group comprised of 2 subjects from each of the AeroVanc in Healthy Volunteers groups.
207032|NCT01537666|O3|Outcome|AeroVanc 80 mg in Healthy Volunteers|Single inhaled dose of 80 mg AeroVanc in health volunteers.
207033|NCT01537666|O2|Outcome|AeroVanc 32 mg in Healthy Volunteers|Single inhaled dose of 32 mg AeroVanc in health volunteers.
207034|NCT01537666|O1|Outcome|AeroVanc 16 mg in Healthy Volunteers|Single inhaled dose of 16 mg AeroVanc in health volunteers.
207035|NCT01537666|E6|Reported Event|IV Vancomycin 250 mg in Healthy Volunteers|Comprised of 2 patients from each of the AeroVanc in Healthy Volunteer groups.
207203|NCT01537068|E1|Reported Event|Desvenlafaxine|"SNRI antidepressant drug~Desvenlafaxine: Desvenlafaxine oral dose ranging from 50 to 100 mg/day"
207036|NCT01537666|E5|Reported Event|AeroVanc 80 mg in Cystic Fibrosis Patients|Single inhaled dose of 80 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
207037|NCT01537666|E4|Reported Event|AeroVanc 32 mg in Cystic Fibrosis Patients|Single inhaled dose of 32 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
207038|NCT01537666|E3|Reported Event|AeroVanc 80 mg in Healthy Volunteers|Single inhaled dose of 80 mg AeroVanc in health volunteers.
207039|NCT01537666|E2|Reported Event|AeroVanc 32 mg in Healthy Volunteers|Single inhaled dose of 32 mg AeroVanc in health volunteers.
207040|NCT01537666|E1|Reported Event|AeroVanc 16 mg in Healthy Volunteers|Single inhaled dose of 16 mg AeroVanc in health volunteers.
207041|NCT01537549|B1|Baseline|Juvenon|alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months
207042|NCT01537549|P1|Participant Flow|Juvenon|alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months
207043|NCT01537549|O2|Outcome|Juvenon at 1 Month|alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily (1 month)
207044|NCT01537549|O1|Outcome|Juvenon at Baseline|at Baseline, no drug taken yet
207045|NCT01537549|O1|Outcome|Juvenon|alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months
207046|NCT01537549|E1|Reported Event|Juvenon|alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months
207047|NCT01537432|B3|Baseline|Total|Total of all reporting groups
207048|NCT01537432|B2|Baseline|Placebo|Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
207049|NCT01537432|B1|Baseline|AIN457 300mg|AIN457 300mg subcutaneously weekly
207050|NCT01537432|P2|Participant Flow|Placebo|Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
207051|NCT01537432|P1|Participant Flow|AIN457 300mg|AIN457 300mg subcutaneously weekly
207052|NCT01537432|O2|Outcome|Placebo|Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
207053|NCT01537432|O1|Outcome|AIN457 300mg|AIN457 300mg subcutaneously weekly
207054|NCT01537432|O2|Outcome|Placebo|Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
207055|NCT01537432|O1|Outcome|AIN457 300mg|AIN457 300mg subcutaneously weekly
207056|NCT01537432|E2|Reported Event|Placebo|Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
207057|NCT01537432|E1|Reported Event|AIN457 300 mg|AIN457 300mg subcutaneously weekly
207058|NCT01537419|B3|Baseline|Total|Total of all reporting groups
207059|NCT01537419|B2|Baseline|Attachment-Based Family Therapy|"Although ABFT therapists implement behavior focused and psychoeducational interventions, the model is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors.~Attachment-Based Family Therapy: Although ABFT therapists implement behavior focused and psychoeducational interventions, the model is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors."
207060|NCT01537419|B1|Baseline|Family-Enhanced Non-directive Supportive Therapy|Family-Enhanced Non-directive Supportive Therapy (FE-NST) is a 16 week therapy designed to control for the non-specific effects of psychotherapy with suicidal youth. FE-NST aims toward relief or reduction of symptoms without expectation of change in the basic personality structure. We have added a parent component to: a) control for parent involvement and b) improve the generalizability and safety of the FE-NST treatment. This enhancement consists of 5 potential parent sessions beginning with a family safety plan in the initial treatment session that will be monitored regularly throughout the treatment. The remaining 4 parent psycho-education sessions offer parents knowledge, skills and support to improve management of the suicidal teen.
207061|NCT01537419|P2|Participant Flow|Attachment-Based Family Therapy|"Although ABFT therapists implement behavior focused and psychoeducational interventions, the model is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors.~Attachment-Based Family Therapy: Although ABFT therapists implement behavior focused and psychoeducational interventions, the model is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors."
207062|NCT01537419|P1|Participant Flow|Family-Enhanced Non-directive Supportive Therapy|Family-Enhanced Non-directive Supportive Therapy (FE-NST) is a 16 week therapy designed to control for the non-specific effects of psychotherapy with suicidal youth. FE-NST aims toward relief or reduction of symptoms without expectation of change in the basic personality structure. We have added a parent component to: a) control for parent involvement and b) improve the generalizability and safety of the FE-NST treatment. This enhancement consists of 5 potential parent sessions beginning with a family safety plan in the initial treatment session that will be monitored regularly throughout the treatment. The remaining 4 parent psycho-education sessions offer parents knowledge, skills and support to improve management of the suicidal teen.
207074|NCT01537393|P2|Participant Flow|8-14d Preservation Time (PT) Group|"Subjects in this arm will receive cornea tissue preserved for 8 to 14 days prior to transplant.~Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days."
207075|NCT01537393|P1|Participant Flow|0-7d Preservation Time (PT) Group|"Subjects in this arm will receive cornea tissue preserved for up to 7 days prior to transplant.~Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days."
207204|NCT01537042|B3|Baseline|Total|Total of all reporting groups
207063|NCT01537419|O2|Outcome|Attachment-Based Family Therapy|"Although ABFT therapists implement behavior focused and psychoeducational interventions, the model is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors.~Attachment-Based Family Therapy: Although ABFT therapists implement behavior focused and psychoeducational interventions, the model is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors."
207064|NCT01537419|O1|Outcome|Family-Enhanced Non-directive Supportive Therapy|Family-Enhanced Non-directive Supportive Therapy (FE-NST) is a 16 week therapy designed to control for the non-specific effects of psychotherapy with suicidal youth. FE-NST aims toward relief or reduction of symptoms without expectation of change in the basic personality structure. We have added a parent component to: a) control for parent involvement and b) improve the generalizability and safety of the FE-NST treatment. This enhancement consists of 5 potential parent sessions beginning with a family safety plan in the initial treatment session that will be monitored regularly throughout the treatment. The remaining 4 parent psycho-education sessions offer parents knowledge, skills and support to improve management of the suicidal teen.
207065|NCT01537419|O2|Outcome|Attachment-Based Family Therapy|"Although ABFT therapists implement behavior focused and psychoeducational interventions, the model is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors.~Attachment-Based Family Therapy: Although ABFT therapists implement behavior focused and psychoeducational interventions, the model is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors."
207066|NCT01537419|O1|Outcome|Family-Enhanced Non-directive Supportive Therapy|Family-Enhanced Non-directive Supportive Therapy (FE-NST) is a 16 week therapy designed to control for the non-specific effects of psychotherapy with suicidal youth. FE-NST aims toward relief or reduction of symptoms without expectation of change in the basic personality structure. We have added a parent component to: a) control for parent involvement and b) improve the generalizability and safety of the FE-NST treatment. This enhancement consists of 5 potential parent sessions beginning with a family safety plan in the initial treatment session that will be monitored regularly throughout the treatment. The remaining 4 parent psycho-education sessions offer parents knowledge, skills and support to improve management of the suicidal teen.
207067|NCT01537419|O2|Outcome|Attachment-Based Family Therapy|"Although ABFT therapists implement behavior focused and psychoeducational interventions, the model is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors.~Attachment-Based Family Therapy: Although ABFT therapists implement behavior focused and psychoeducational interventions, the model is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors."
207068|NCT01537419|O1|Outcome|Family-Enhanced Non-directive Supportive Therapy|Family-Enhanced Non-directive Supportive Therapy (FE-NST) is a 16 week therapy designed to control for the non-specific effects of psychotherapy with suicidal youth. FE-NST aims toward relief or reduction of symptoms without expectation of change in the basic personality structure. We have added a parent component to: a) control for parent involvement and b) improve the generalizability and safety of the FE-NST treatment. This enhancement consists of 5 potential parent sessions beginning with a family safety plan in the initial treatment session that will be monitored regularly throughout the treatment. The remaining 4 parent psycho-education sessions offer parents knowledge, skills and support to improve management of the suicidal teen.
207069|NCT01537419|E2|Reported Event|Attachment-Based Family Therapy|"Although ABFT therapists implement behavior focused and psychoeducational interventions, the model is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors.~Attachment-Based Family Therapy: Although ABFT therapists implement behavior focused and psychoeducational interventions, the model is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors."
207070|NCT01537419|E1|Reported Event|Family-Enhanced Non-directive Supportive Therapy|Family-Enhanced Non-directive Supportive Therapy (FE-NST) is a 16 week therapy designed to control for the non-specific effects of psychotherapy with suicidal youth. FE-NST aims toward relief or reduction of symptoms without expectation of change in the basic personality structure. We have added a parent component to: a) control for parent involvement and b) improve the generalizability and safety of the FE-NST treatment. This enhancement consists of 5 potential parent sessions beginning with a family safety plan in the initial treatment session that will be monitored regularly throughout the treatment. The remaining 4 parent psycho-education sessions offer parents knowledge, skills and support to improve management of the suicidal teen.
207071|NCT01537393|B3|Baseline|Total|Total of all reporting groups
207072|NCT01537393|B2|Baseline|Preservation Time Group 2|"Subjects in this arm will receive cornea tissue preserved for 8 to 14 days prior to transplant.~Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days."
207073|NCT01537393|B1|Baseline|Preservation Time Group 1|"Subjects in this arm will receive cornea tissue preserved for up to 7 days prior to transplant.~Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days."
207205|NCT01537042|B2|Baseline|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
207076|NCT01537393|O2|Outcome|Preservation Time Group 2|"Subjects in this arm will receive cornea tissue preserved for 8 to 14 days prior to transplant.~Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days."
207077|NCT01537393|O1|Outcome|Preservation Time Group 1|"Subjects in this arm will receive cornea tissue preserved for up to 7 days prior to transplant.~Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days."
207078|NCT01537393|O2|Outcome|Preservation Time Group 2|"Subjects in this arm will receive cornea tissue preserved for 8 to 14 days prior to transplant.~Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days."
207079|NCT01537393|O1|Outcome|Preservation Time Group 1|"Subjects in this arm will receive cornea tissue preserved for up to 7 days prior to transplant.~Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days."
207080|NCT01537393|E2|Reported Event|8-14d Preservation Time Group|"Subjects in this arm will receive cornea tissue preserved for 8 to 14 days prior to transplant.~Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days."
207081|NCT01537393|E1|Reported Event|0-7d Preservation Time Group|"Subjects in this arm will receive cornea tissue preserved for up to 7 days prior to transplant.~Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days."
207082|NCT01537367|B4|Baseline|Total|Total of all reporting groups
207083|NCT01537367|B3|Baseline|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
207084|NCT01537367|B2|Baseline|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
207085|NCT01537367|B1|Baseline|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient related to making and seeing clinic appointments.
207086|NCT01537367|P3|Participant Flow|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
207087|NCT01537367|P2|Participant Flow|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
207088|NCT01537367|P1|Participant Flow|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.
207089|NCT01537367|O3|Outcome|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
207090|NCT01537367|O2|Outcome|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
207091|NCT01537367|O1|Outcome|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.
207092|NCT01537367|O3|Outcome|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
207093|NCT01537367|O2|Outcome|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
207166|NCT01537120|P1|Participant Flow|Placebo → Vildagliptin|Participants received placebo tablets orally, twice a day for 3 weeks, and then over the next 12 weeks received vildagliptin 50 mg tablets orally, twice daily
207094|NCT01537367|O1|Outcome|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.
207095|NCT01537367|O3|Outcome|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
207096|NCT01537367|O2|Outcome|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
207097|NCT01537367|O1|Outcome|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.
207098|NCT01537367|E3|Reported Event|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
207099|NCT01537367|E2|Reported Event|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
207100|NCT01537367|E1|Reported Event|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.
207101|NCT01537315|B3|Baseline|Total|Total of all reporting groups
207102|NCT01537315|B2|Baseline|Hydroxychloroquine|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Hydroxychloroquine: 200 mg capsule daily for 10 +/- 4 days, then 200 mg twice daily till end of study (duration approximately 6 months)"
207103|NCT01537315|B1|Baseline|Matching Placebo|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Placebo comparator: matching capsule 200 mg daily for 10 +/- 4 days and thereafter 200 mg twice a day for duration of study, approximately 6 months"
207104|NCT01537315|P2|Participant Flow|Hydroxychloroquine|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Hydroxychloroquine: 200 mg capsule daily for 10 +/- 4 days, then 200 mg twice daily till end of study (duration approximately 6 months)"
207105|NCT01537315|P1|Participant Flow|Matching Placebo|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Placebo comparator: matching capsule 200 mg daily for 10 +/- 4 days and thereafter 200 mg twice a day for duration of study, approximately 6 months"
207106|NCT01537315|O2|Outcome|Hydroxychloroquine|"Patients with cardiovascular disease (CVD) and chronic kidney disease (CKD) will be randomized to either hydroxychloroquine (HCQ) or matching placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Hydroxychloroquine: 200 mg capsule daily for 10 +/- 4 days, then 200 mg twice daily till end of study (duration approximately 6 months)"
207107|NCT01537315|O1|Outcome|Matching Placebo|"Patients with cardiovascular disease (CVD) and chronic kidney disease (CKD) will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Placebo comparator: matching placebo capsule 200 mg daily for 10 +/- 4 days and thereafter 200 mg twice a day for duration of study, approximately 6 months"
207108|NCT01537315|E2|Reported Event|Hydroxychloroquine|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Hydroxychloroquine: 200 mg capsule daily for 10 +/- 4 days, then 200 mg twice daily till end of study (duration approximately 6 months)"
207109|NCT01537315|E1|Reported Event|Matching Placebo|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Placebo comparator: matching capsule 200 mg daily for 10 +/- 4 days and thereafter 200 mg twice a day for duration of study, approximately 6 months"
207110|NCT01537302|B1|Baseline|Ocelot|CTO crossing in femoropopliteal arteries using the Ocelot System
207111|NCT01537302|P1|Participant Flow|Treatment Arm|CTO crossing in femoropopliteal arteries using the Ocelot System
207112|NCT01537302|O1|Outcome|Treatment Arm|CTO crossing in femoropopliteal arteries using the Ocelot System
207113|NCT01537302|O1|Outcome|Treatment Arm|CTO crossing in femoropopliteal arteries using the Ocelot System
207114|NCT01537302|O1|Outcome|Treatment Arm|CTO crossing in femoropopliteal arteries using the Ocelot System
207115|NCT01537302|O1|Outcome|Treatment Arm|CTO crossing in femoropopliteal arteries using the Ocelot System
207116|NCT01537302|E1|Reported Event|Treatment Arm|CTO crossing in femoropopliteal arteries CONNECT II: CTO crossing in femoropopliteal arteries using the Ocelot System
207167|NCT01537120|O2|Outcome|Vildagliptin|Vildagliptin tablets 50 mg twice daily for 12 weeks
207168|NCT01537120|O1|Outcome|Placebo|Placebo tablets twice daily for 3 weeks
207117|NCT01537198|B1|Baseline|Pediatric Participants at High Risk of RSV|Pediatric participants at high risk of RSV in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant’s enrollment in the study.
207118|NCT01537198|P1|Participant Flow|Pediatric Participants at High Risk of RSV|Pediatric participants at high risk of respiratory syncytial virus (RSV) in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant’s enrollment in the study.
207119|NCT01537198|O1|Outcome|Pediatric Participants at High Risk of RSV|Pediatric participants at high risk of RSV in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant’s enrollment in the study.
207120|NCT01537198|E1|Reported Event|Pediatric Participants at High Risk of RSV|Pediatric participants at high risk of RSV in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant’s enrollment in the study.
207121|NCT01537185|B5|Baseline|Total|Total of all reporting groups
207122|NCT01537185|B4|Baseline|Cohort 3 SPWCV+Alum 600 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
207123|NCT01537185|B3|Baseline|Cohort 2 SPWCV+Alum 300 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
207124|NCT01537185|B2|Baseline|Normal Saline Injection|"placebo group within each cohort receive 3 injections of normal saline 28 days apart~normal saline injection: 3 cohorts of normal saline injection"
207125|NCT01537185|B1|Baseline|Cohort 1 SPWCV+Alum 100 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
207126|NCT01537185|P4|Participant Flow|Cohort 3 SPWVC+Alum 600 mcg|each individual receiving 3 vaccinations of the same dose 28 days apart
207127|NCT01537185|P3|Participant Flow|Cohort 2 SPWCV+Alum 300 mcg|each individual receiving 3 vaccinations of the same dose 28 days apart
207128|NCT01537185|P2|Participant Flow|Normal Saline Injection|"placebo group within each cohort receive 3 injections of normal saline 28 days apart~normal saline injection: 3 cohorts of normal saline injection"
207129|NCT01537185|P1|Participant Flow|Cohort 1 SPWCV+Alum 100 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
207130|NCT01537185|O4|Outcome|Cohort 3 SPWVC+Alum 600 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
207131|NCT01537185|O3|Outcome|Cohort 2 SPWCV+Alum 300 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
207132|NCT01537185|O2|Outcome|Normal Saline Injection|"placebo group within each cohort receive 3 injections of normal saline 28 days apart~normal saline injection: 3 cohorts of normal saline injection"
207133|NCT01537185|O1|Outcome|Cohort 1 SPWCV+Alum 100 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
207134|NCT01537185|O4|Outcome|Cohort 3 SPWVC+Alum 600 mcg|each individual receiving 3 vaccinations of the same dose 28 days apart
207135|NCT01537185|O3|Outcome|Cohort 2 SPWCV+Alum 300 mcg|each individual receiving 3 vaccinations of the same dose 28 days apart
207136|NCT01537185|O2|Outcome|Normal Saline Injection|"placebo group within each cohort receive 3 injections of normal saline 28 days apart~normal saline injection: 3 cohorts of normal saline injection"
207137|NCT01537185|O1|Outcome|Cohort 1 SPWCV+Alum 100 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
207138|NCT01537185|E4|Reported Event|Cohort 3 SPWCV+Alum 600 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
207139|NCT01537185|E3|Reported Event|Cohort 2 SPWCV+Alum 300 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
207140|NCT01537185|E2|Reported Event|Normal Saline Injection|"placebo group within each cohort receive 3 injections of normal saline 28 days apart~normal saline injection: 3 cohorts of normal saline injection"
207141|NCT01537185|E1|Reported Event|Cohort 1 SPWCV+Alum 100 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
207142|NCT01537133|B5|Baseline|Total|Total of all reporting groups
207143|NCT01537133|B4|Baseline|Healthy Control|
207144|NCT01537133|B3|Baseline|Atopic Non-asthmatics|
207145|NCT01537133|B2|Baseline|Atopic Asthmatics Treated With Placebo|Placebo fluticasone (one puff, twice a day)
207146|NCT01537133|B1|Baseline|Atopic Asthmatics Treated With Inhaled Corticosteroid|Fluticasone (250 mcg/puff, one puff, twice a day)
207147|NCT01537133|P4|Participant Flow|Atopic Non-asthmatics|
207148|NCT01537133|P3|Participant Flow|Healthy Control|
207149|NCT01537133|P2|Participant Flow|Placebo|Placebo fluticasone (one puff, twice a day)
207150|NCT01537133|P1|Participant Flow|Inhaled Corticosteroid|Fluticasone (250 mcg/puff, one puff, twice a day)
207151|NCT01537133|O4|Outcome|Healthy Control|
207152|NCT01537133|O3|Outcome|Atopic Non-asthmatics|
207153|NCT01537133|O2|Outcome|Atopic Asthmatics Treated With Placebo|
207154|NCT01537133|O1|Outcome|Atopic Asthmatics Treated With Inhaled Corticosteroids|
207155|NCT01537133|O4|Outcome|Healthy Control|
207156|NCT01537133|O3|Outcome|Atopic Non-asthmatics|
207157|NCT01537133|O2|Outcome|Atopic Asthmatics Treated With Placebo|
207158|NCT01537133|O1|Outcome|Atopic Asthmatics Treated With Inhaled Corticosteroids|
207159|NCT01537133|O4|Outcome|Healthy Control|
207160|NCT01537133|O3|Outcome|Atopic Non-asthmatics|
207161|NCT01537133|O2|Outcome|Atopic Asthmatics Treated With Placebo|
207162|NCT01537133|O1|Outcome|Atopic Asthmatics Treated With Inhaled Corticosteroids|
207163|NCT01537133|E2|Reported Event|Placebo|Placebo fluticasone (one puff, twice a day)
207164|NCT01537133|E1|Reported Event|Inhaled Corticosteroid|Fluticasone (250 mcg/puff, one puff, twice a day)
207165|NCT01537120|B1|Baseline|Placebo → Vildagliptin|Participants received placebo tablets orally, twice a day for 3 weeks, and then over the next 12 weeks received vildagliptin 50 mg tablets orally, twice daily
207176|NCT01537081|B3|Baseline|Placebo|Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
207177|NCT01537081|B2|Baseline|Immediate-release Guaifenesin 800 mg/Day|The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
207178|NCT01537081|B1|Baseline|Mucinex 2400 mg/Day|The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex 600-mg tablets and 1 placebo tablet matching the 200 mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
207179|NCT01537081|P3|Participant Flow|Placebo|Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
207180|NCT01537081|P2|Participant Flow|Immediate-release Guaifenesin 800 mg/Day|The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
207181|NCT01537081|P1|Participant Flow|Mucinex 2400 mg/Day|The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex (600-mg) tablets and 1 placebo tablet matching the 200-mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
207182|NCT01537081|O3|Outcome|Placebo|Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
207183|NCT01537081|O2|Outcome|Immediate-release Guaifenesin 800 mg/Day|The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
207184|NCT01537081|O1|Outcome|Mucinex 2400 mg/Day|The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex (600-mg) tablets and 1 placebo tablet matching the 200-mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
207185|NCT01537081|O3|Outcome|Placebo|Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
207186|NCT01537081|O2|Outcome|Immediate-release Guaifenesin 800 mg/Day|The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
207187|NCT01537081|O1|Outcome|Mucinex 2400 mg/Day|The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex 600-mg tablets and 1 placebo tablet matching the 200 mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
207188|NCT01537081|E3|Reported Event|Placebo|Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
207189|NCT01537081|E2|Reported Event|Immediate-release Guaifenesin 800 mg/Day|The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
207190|NCT01537081|E1|Reported Event|Mucinex 2400 mg/Day|The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex 600-mg tablets and 1 placebo tablet matching the 200 mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
207191|NCT01537068|B3|Baseline|Total|Total of all reporting groups
207192|NCT01537068|B2|Baseline|Placebo|"Placebo treatment~Placebo: Matching placebo pills"
207193|NCT01537068|B1|Baseline|Desvenlafaxine|"SNRI antidepressant drug~Desvenlafaxine: Desvenlafaxine oral dose ranging from 50 to 100 mg/day"
207194|NCT01537068|P2|Participant Flow|Placebo|"Placebo treatment~Placebo: Matching placebo pills"
207195|NCT01537068|P1|Participant Flow|Desvenlafaxine|"Serotonin–norepinephrine reuptake inhibitors (SNRIs) antidepressant drug~Desvenlafaxine: Desvenlafaxine oral dose ranging from 50 to 100 mg/day"
207196|NCT01537068|O2|Outcome|Placebo|"Placebo treatment~Placebo: Matching placebo pills"
207197|NCT01537068|O1|Outcome|Desvenlafaxine|"SNRI antidepressant drug~Desvenlafaxine: Desvenlafaxine oral dose ranging from 50 to 100 mg/day"
207198|NCT01537068|O2|Outcome|Placebo|"Placebo treatment~Placebo: Matching placebo pills"
207199|NCT01537068|O1|Outcome|Desvenlafaxine|"SNRI antidepressant drug~Desvenlafaxine: Desvenlafaxine oral dose ranging from 50 to 100 mg/day"
207200|NCT01537068|O2|Outcome|Placebo|"Placebo treatment~Placebo: Matching placebo pills"
207201|NCT01537068|O1|Outcome|Desvenlafaxine|"SNRI antidepressant drug~Desvenlafaxine: Desvenlafaxine oral dose ranging from 50 to 100 mg/day"
207206|NCT01537042|B1|Baseline|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
207207|NCT01537042|P2|Participant Flow|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h.~Subjects start with a Rotigotine dose of 1 mg/24 h for 1 week. The dose can be increased weekly during Up-Titration Period until either the optimal or the maximal dose of 3 mg/24 h has been reached. Subjects will maintain the optimal/maximal dose during the 2-week Maintenance Period. Following the Maintenance Period, subjects will be de-escalated from their optimal dose by decreasing the dose by 1 mg/24 h every other day during Taper Period until complete withdrawal."
207208|NCT01537042|P1|Participant Flow|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance.~Up to 3 weeks of Titration,~2 weeks of Maintenance,~Up to 4 days of Taper Period."
207209|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
207210|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
207211|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
207212|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
207213|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
207214|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
207215|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
207216|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
207217|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
207218|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
207219|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
207220|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
207221|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
207222|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
207223|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
207224|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
207225|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
207226|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
207227|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
207228|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
207229|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
207230|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
207231|NCT01537042|O4|Outcome|Rotigotine (Visit 6)|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
207232|NCT01537042|O3|Outcome|Placebo (Visit 6)|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
207233|NCT01537042|O2|Outcome|Rotigotine (Visit 2)|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
207234|NCT01537042|O1|Outcome|Placebo (Visit 2)|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
207235|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
207236|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
207237|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
207238|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
207239|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
207240|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
207241|NCT01537042|E2|Reported Event|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
207242|NCT01537042|E1|Reported Event|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
207243|NCT01536951|B3|Baseline|Total|Total of all reporting groups
207244|NCT01536951|B2|Baseline|Part B (LY3009104, Moxifloxacin, or Placebo)|Participants were randomized to 1 of 6 treatment sequences during Part B of the study and received a single dose (LY3009104, moxifloxacin, or placebo) in each period separated by a washout of at least 3 days. LY3009104 was administered as a 40-mg dose. Moxifloxacin was administered as a 400-mg tablet.
207245|NCT01536951|B1|Baseline|Part A (LY3009104 or Placebo)|Participants were randomized to 1 of 3 treatment sequences during Part A of the study and received a single dose (LY3009104 or placebo) in each period separated by a washout of at least 3 days. LY3009104 was administered as either 20-milligrams (mg), 30-mg or 40-mg dose.
207246|NCT01536951|P9|Participant Flow|Part B: Placebo, 40 mg LY3009104, Moxifloxacin|"First Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.~Second Intervention: 40-mg LY3009104 dose administered orally once.~Third Intervention: A single 400-mg moxifloxacin tablet administered orally once.~There was a washout of at least 3 days between each intervention."
207247|NCT01536951|P8|Participant Flow|Part B: 40 mg LY3009104, Moxifloxacin, Placebo|"First Intervention: 40-mg LY3009104 dose administered orally once.~Second Intervention: A single 400-mg moxifloxacin tablet administered orally once.~Third Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.~There was a washout of at least 3 days between each intervention."
207248|NCT01536951|P7|Participant Flow|Part B: Moxifloxacin, Placebo, 40 mg LY3009104|"First Intervention: A single 400-mg moxifloxacin tablet administered orally once.~Second Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.~Third Intervention: 40-mg LY3009104 dose administered orally once.~There was a washout of at least 3 days between each intervention."
207249|NCT01536951|P6|Participant Flow|Part B: Moxifloxacin, 40 mg LY3009104, Placebo|"First Intervention: A single 400-mg moxifloxacin tablet administered orally once.~Second Intervention: 40-mg LY3009104 dose administered orally once.~Third Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.~There was a washout of at least 3 days between each intervention."
207250|NCT01536951|P5|Participant Flow|Part B: Placebo, Moxifloxacin, 40 mg LY3009104|"First Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.~Second Intervention: A single 400-mg moxifloxacin tablet administered orally once.~Third Intervention: 40-mg LY3009104 dose administered orally once.~There was a washout of at least 3 days between each intervention."
207251|NCT01536951|P4|Participant Flow|Part B: 40 mg LY3009104, Placebo, Moxifloxacin|"First Intervention: 40-mg LY3009104 dose administered orally once.~Second Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.~Third Intervention: A single 400-mg moxifloxacin tablet administered orally once.~There was a washout of at least 3 days between each intervention."
207252|NCT01536951|P3|Participant Flow|Part A: 20 mg LY3009104, Placebo, 40 mg LY3009104|"First Intervention: 20-mg LY3009104 dose administered orally once.~Second Intervention: Placebo tablets (matching 30-mg LY3009104) administered orally once.~Third Intervention: 40-mg LY3009104 dose administered orally once.~There was a washout of at least 3 days between each intervention."
207253|NCT01536951|P2|Participant Flow|Part A: 20 mg LY3009104, 30 mg LY3009104, Placebo|"First Intervention: 20-mg LY3009104 dose administered orally once.~Second Intervention: 30-mg LY3009104 dose administered orally once.~Third Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.~There was a washout of at least 3 days between each intervention."
207254|NCT01536951|P1|Participant Flow|Part A: Placebo, 30 mg LY3009104, 40 mg LY3009104|"First Intervention: Placebo tablets [matching 20-mg LY3009104] administered orally once.~Second Intervention: 30-mg LY3009104 dose administered orally once.~Third Intervention: 40-mg LY3009104 dose administered orally once.~There was a washout of at least 3 days between each intervention."
207255|NCT01536951|O7|Outcome|Part B: Moxifloxacin|A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.
207256|NCT01536951|O6|Outcome|Part B: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
207257|NCT01536951|O5|Outcome|Part B: Placebo|Placebo tablets (matching 40-mg LY3009104) administered orally once in any period during Part B of the study.
207258|NCT01536951|O4|Outcome|Part A: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in Part A, Period 3 of the study.
207259|NCT01536951|O3|Outcome|Part A: 30 mg LY3009104|A 30-mg LY3009104 dose administered orally once in Part A, Period 2 of the study.
207260|NCT01536951|O2|Outcome|Part A: 20 mg LY3009104|A 20-mg LY3009104 dose administered orally once in Part A, Period 1 of the study.
207261|NCT01536951|O1|Outcome|Part A: Placebo|Placebo tablets [matching 20-milligrams (mg), 30-mg, or 40-mg LY3009104] administered orally once in any period during Part A of the study.
207262|NCT01536951|O4|Outcome|Part B: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
207263|NCT01536951|O3|Outcome|Part A: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in Part A, Period 3 of the study.
207264|NCT01536951|O2|Outcome|Part A: 30 mg LY3009104|A 30-mg LY3009104 dose administered orally once in Part A, Period 2 of the study.
207265|NCT01536951|O1|Outcome|Part A: 20 mg LY3009104|A 20-milligram (mg) LY3009104 dose administered orally once in Part A, Period 1 of the study.
207266|NCT01536951|O4|Outcome|Part B: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
207267|NCT01536951|O3|Outcome|Part A: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in Part A, Period 3 of the study.
207268|NCT01536951|O2|Outcome|Part A: 30 mg LY3009104|A 30-mg LY3009104 dose administered orally once in Part A, Period 2 of the study.
207269|NCT01536951|O1|Outcome|Part A: 20 mg LY3009104|A 20-milligram (mg) LY3009104 dose administered orally once in Part A, Period 1 of the study.
207270|NCT01536951|O3|Outcome|Part B: Moxifloxacin|A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.
207271|NCT01536951|O2|Outcome|Part B: 40 mg LY3009104|A 40-milligram (mg) dose of LY3009104 administered orally once in any period during Part B of the study.
207272|NCT01536951|O1|Outcome|Part B: Placebo|Placebo tablets (matching LY3009104) administered orally once in any period during Part B of the study.
207273|NCT01536951|E7|Reported Event|Part B: Moxifloxacin|A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.
207274|NCT01536951|E6|Reported Event|Part B: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
207275|NCT01536951|E5|Reported Event|Part B: Placebo|Placebo tablets (matching 40-mg LY3009104) administered orally once in any period during Part B of the study.
207276|NCT01536951|E4|Reported Event|Part A: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in Part A, Period 3 of the study.
207277|NCT01536951|E3|Reported Event|Part A: 30 mg LY3009104|A 30-mg LY3009104 dose administered orally once in Part A, Period 2 of the study.
207278|NCT01536951|E2|Reported Event|Part A: 20 mg LY3009104|A 20-mg LY3009104 dose administered orally once in Part A, Period 1 of the study.
207279|NCT01536951|E1|Reported Event|Part A: Placebo|Placebo tablets [matching 20-milligrams (mg), 30-mg, or 40-mg LY3009104] administered orally once in any period during Part A of the study.
207280|NCT01536938|B4|Baseline|Total|Total of all reporting groups
207281|NCT01536938|B3|Baseline|Calcipotriol Aerosol Foam|Calcipotriol aerosol foam: calcipotriol 50 mcg/g. Applied once daily for up to 4 weeks
207282|NCT01536938|B2|Baseline|Betamethasone Dipropionate|Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
207283|NCT01536938|B1|Baseline|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
207284|NCT01536938|P3|Participant Flow|Calcipotriol Aerosol Foam|"Calcipotriol aerosol foam: calcipotriol 50 mcg/g.~Applied once daily for up to 4 weeks"
207285|NCT01536938|P2|Participant Flow|Betamethasone Dipropionate|"Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate)~Applied once daily for up to 4 weeks"
207286|NCT01536938|P1|Participant Flow|LEO 90100|"LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)~Applied once daily for up to 4 weeks"
207287|NCT01536938|O3|Outcome|Calcipotriol Aerosol Foam|Calcipotriol aerosol foam: calcipotriol 50 mcg/g. Applied once daily for up to 4 weeks
207288|NCT01536938|O2|Outcome|Betamethasone Dipropionate|Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
207289|NCT01536938|O1|Outcome|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
207290|NCT01536938|E3|Reported Event|Calcipotriol Aerosol Foam|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
207291|NCT01536938|E2|Reported Event|Betamethasone Dipropionate|Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
207292|NCT01536938|E1|Reported Event|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
207293|NCT01536886|B5|Baseline|Total|Total of all reporting groups
207294|NCT01536886|B4|Baseline|Ointment Vehicle|Ointment with no active ingredients
207295|NCT01536886|B3|Baseline|LEO 90100 Vehicle|Aerosol foam with no active ingredients
207296|NCT01536886|B2|Baseline|Calcipotriol Plus BDP Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
207297|NCT01536886|B1|Baseline|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
207298|NCT01536886|P4|Participant Flow|Ointment Vehicle|Ointment with no active ingredients
207299|NCT01536886|P3|Participant Flow|LEO 90100 Vehicle|Aerosol foam with no active ingredients
207300|NCT01536886|P2|Participant Flow|Calcipotriol Plus BDP Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
207301|NCT01536886|P1|Participant Flow|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
207302|NCT01536886|O4|Outcome|Ointment Vehicle|Ointment with no active ingredients
207303|NCT01536886|O3|Outcome|LEO 90100 Vehicle|Aerosol foam with no active ingredients
207304|NCT01536886|O2|Outcome|Calcipotriol Plus BDP Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
207305|NCT01536886|O1|Outcome|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
207306|NCT01536886|E4|Reported Event|Ointment Vehicle|Ointment with no active ingredients
207307|NCT01536886|E3|Reported Event|LEO 90100 Vehicle|Aerosol foam with no active ingredients
207308|NCT01536886|E2|Reported Event|Calcipotriol Plus BDP Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
207309|NCT01536886|E1|Reported Event|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
207310|NCT01536860|B1|Baseline|Entire Study Population|Includes groups randomized to receive Control Test Drink first, Exp Test Drink 1 first and Exp Test Drink 2 first.
207311|NCT01536860|P3|Participant Flow|Exp Test Drink 2/Control Test Drink/ Exp Test Drink 1|"Consume Exp Test Drink 2 once over a 15 minute period followed by a 3 day wash out period.~Consume Control Test Drink once over a 15 minute period followed by a 3 day wash out period.~Consume Exp Test Drink 1 once over a 15 minute period."
207312|NCT01536860|P2|Participant Flow|Exp Test Drink 1/Control Test Drink/Exp Test Drink 2|"Consume Exp Test Drink 1 once over a 15 minute period followed by a 3 day wash out period.~Consume Control Test Drink once over a 15 minute period followed by a 3 day wash out period.~Consume Exp Test Drink 2 once over a 15 minute period."
207313|NCT01536860|P1|Participant Flow|Control Test Drink/Exp Test Drink 1/Exp Test Drink 2|"Consume Control Test Drink once over a 15 minute period followed by a 3 day wash out period.~Consume Exp Test Drink 1 followed by a 3 day wash out period. Consume Exp Test Drink 2 over a 15 minute period"
207314|NCT01536860|O3|Outcome|Experimental Test Drink 2|"Control Drink containing ingredient 2~Dietary Intervention : 300 ml of liquid food product"
207315|NCT01536860|O2|Outcome|Experimental Test Drink 1|"Control Drink containing ingredient 1~Dietary Intervention : 300 ml of liquid food product"
207316|NCT01536860|O1|Outcome|Control Test Drink|"Control Drink~Dietary Intervention : 300 ml of liquid food product"
207317|NCT01536860|E3|Reported Event|Experimental Test Drink 2|"Control Drink containing ingredient 2~Dietary Intervention : 300 ml of liquid food product"
207318|NCT01536860|E2|Reported Event|Experimental Test Drink 1|"Control Drink containing ingredient 1~Dietary Intervention : 300 ml of liquid food product"
207319|NCT01536860|E1|Reported Event|Control Test Drink|"Control Drink~Dietary Intervention : 300 ml of liquid food product"
207320|NCT01536704|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline measures
207321|NCT01536704|P4|Participant Flow|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
207322|NCT01536704|P3|Participant Flow|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
207323|NCT01536704|P2|Participant Flow|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
207324|NCT01536704|P1|Participant Flow|2 Milligram (mg) Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
207325|NCT01536704|O4|Outcome|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
207326|NCT01536704|O3|Outcome|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
207327|NCT01536704|O2|Outcome|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
207328|NCT01536704|O1|Outcome|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
207329|NCT01536704|O4|Outcome|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
207330|NCT01536704|O3|Outcome|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
207331|NCT01536704|O2|Outcome|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
207332|NCT01536704|O1|Outcome|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
207333|NCT01536704|O4|Outcome|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
207334|NCT01536704|O3|Outcome|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
207335|NCT01536704|O2|Outcome|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
207336|NCT01536704|O1|Outcome|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
207337|NCT01536704|O4|Outcome|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
207338|NCT01536704|O3|Outcome|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
207339|NCT01536704|O2|Outcome|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
207340|NCT01536704|O1|Outcome|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
207341|NCT01536704|O4|Outcome|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
207342|NCT01536704|O3|Outcome|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
207343|NCT01536704|O2|Outcome|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
207344|NCT01536704|O1|Outcome|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
207345|NCT01536704|O4|Outcome|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
207346|NCT01536704|O3|Outcome|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
207347|NCT01536704|O2|Outcome|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
207348|NCT01536704|O1|Outcome|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
207389|NCT01536587|E1|Reported Event|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207349|NCT01536704|E4|Reported Event|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
207350|NCT01536704|E3|Reported Event|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
207351|NCT01536704|E2|Reported Event|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
207352|NCT01536704|E1|Reported Event|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
207353|NCT01536587|B1|Baseline|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207354|NCT01536587|P1|Participant Flow|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207355|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207356|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207357|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207358|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207359|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207360|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207361|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207362|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207363|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207364|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207365|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207366|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207367|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207368|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207369|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207370|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207371|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207372|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207373|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207374|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207375|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207376|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207377|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207378|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207379|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207380|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207381|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207382|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207383|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207384|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207385|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207386|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207387|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207388|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
207391|NCT01536574|B2|Baseline|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
207392|NCT01536574|B1|Baseline|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
207393|NCT01536574|P2|Participant Flow|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
207394|NCT01536574|P1|Participant Flow|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
207395|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
207396|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
207397|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
207398|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
207496|NCT01536418|O1|Outcome|GSK1605786A 500 mg, Once Daily|Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.
207497|NCT01536418|O2|Outcome|GSK1605786A 500 mg, Twice Daily|Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
207399|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
207400|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
207401|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
207402|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
207403|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
207404|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
207405|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
207406|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
207498|NCT01536418|O1|Outcome|GSK1605786A 500 mg, Once Daily|Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.
207499|NCT01536418|O2|Outcome|GSK1605786A 500 mg, Twice Daily|Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
207407|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
207408|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
207409|NCT01536574|E2|Reported Event|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
207410|NCT01536574|E1|Reported Event|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
207411|NCT01536561|B1|Baseline|TST and Iodine I 131 TST|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
207412|NCT01536561|P1|Participant Flow|TST and Iodine I 131 TST|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
207413|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
207414|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
207415|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
207416|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
207417|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
207418|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
207419|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
207420|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
207421|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
207500|NCT01536418|O1|Outcome|GSK1605786A 500 mg, Once Daily|Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.
207501|NCT01536418|O2|Outcome|GSK1605786A 500 mg, Twice Daily|Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
207422|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
207423|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
207424|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
207425|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
207426|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
207427|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
207428|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
207502|NCT01536418|O1|Outcome|GSK1605786A 500 mg, Once Daily|Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.
207503|NCT01536418|O2|Outcome|GSK1605786A 500 mg,Twice Daily|Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
207429|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
207430|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
207431|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
207432|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
207433|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
207434|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
207435|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
207504|NCT01536418|O1|Outcome|GSK1605786A 500 mg, Once Daily|Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.
207505|NCT01536418|E2|Reported Event|GSK1605786A 500 mg, Twice Daily|Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
207436|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
207437|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
207438|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
207439|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
207440|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
207441|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
207442|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
207506|NCT01536418|E1|Reported Event|GSK1605786A 500 mg, Once Daily|Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.
207507|NCT01536405|B3|Baseline|Total|Total of all reporting groups
207508|NCT01536405|B2|Baseline|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
207443|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
207444|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
207445|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study."
207446|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
207447|NCT01536561|E2|Reported Event|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:&gt;=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study."
207448|NCT01536561|E1|Reported Event|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
207449|NCT01536496|B3|Baseline|Total|Total of all reporting groups
207450|NCT01536496|B2|Baseline|Test (r-TEG)|
207451|NCT01536496|B1|Baseline|Control (INR, PTT, Fibrinogen, D-dimer)|
207452|NCT01536496|P2|Participant Flow|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
207509|NCT01536405|B1|Baseline|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
207453|NCT01536496|P1|Participant Flow|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
207454|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
207455|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
207456|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
207457|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
207458|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
207459|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
207510|NCT01536405|P2|Participant Flow|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
207511|NCT01536405|P1|Participant Flow|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
207512|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
208546|NCT01533181|B2|Baseline|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
207460|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
207461|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
207462|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
207463|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
207464|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
207465|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
207466|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
207513|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
207514|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
207515|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
207467|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
207468|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
207469|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
207470|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
207471|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
207472|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
207473|NCT01536496|O1|Outcome|Control (INR, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
207516|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
207517|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
207518|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
207522|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
207474|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
207475|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
207476|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
207477|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
207478|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
207479|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
207480|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
207519|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
207520|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
207521|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
207481|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
207482|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
207483|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
207484|NCT01536496|E2|Reported Event|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
207485|NCT01536496|E1|Reported Event|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
207486|NCT01536418|B3|Baseline|Total|Total of all reporting groups
207487|NCT01536418|B2|Baseline|GSK1605786A 500 mg, Twice Daily|Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
207488|NCT01536418|B1|Baseline|GSK1605786A 500 mg, Once Daily|Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.
207489|NCT01536418|P2|Participant Flow|GSK1605786A, 500 mg Twice Daily|Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
207490|NCT01536418|P1|Participant Flow|GSK1605786A, 500 Milligram (mg), Once Daily|Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.
207491|NCT01536418|O2|Outcome|GSK1605786A 500 mg, Twice Daily|Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
207492|NCT01536418|O1|Outcome|GSK1605786A 500 mg, Once Daily|Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.
207493|NCT01536418|O2|Outcome|GSK1605786A 500 mg, Twice Daily|Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
207494|NCT01536418|O1|Outcome|GSK1605786A 500 mg, Once Daily|Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.
207495|NCT01536418|O2|Outcome|GSK1605786A 500 mg, Twice Daily|Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
208058|NCT01535222|O5|Outcome|Cohort 5|loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
207523|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
207524|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
207525|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
207526|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
207527|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
207528|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
207529|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
207530|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
207531|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
207532|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
207533|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
207534|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
207535|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
207536|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
207537|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
207538|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
207539|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
207540|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
207541|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
207542|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
207543|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
207544|NCT01536405|E2|Reported Event|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
207545|NCT01536405|E1|Reported Event|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
207546|NCT01536379|B3|Baseline|Total|Total of all reporting groups
207547|NCT01536379|B2|Baseline|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207548|NCT01536379|B1|Baseline|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207549|NCT01536379|P2|Participant Flow|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207550|NCT01536379|P1|Participant Flow|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207551|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207552|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207553|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207554|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207555|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207556|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207557|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207558|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207559|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207560|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207561|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207562|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207563|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207564|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207565|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207566|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207567|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207568|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207569|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207570|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207571|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207572|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
208937|NCT01532128|O3|Outcome|Rasagiline Concomitant BIA 9-1067|Rasagiline concomitant BIA 9-1067.
207573|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207574|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207575|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207576|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207577|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207578|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207579|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207580|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207581|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207582|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207583|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207584|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207585|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207586|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207587|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207588|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207589|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207590|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207591|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207592|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207593|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207594|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207595|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207596|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207597|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207598|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207599|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207600|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207601|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207602|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207603|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207604|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207605|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207606|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207607|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207608|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207609|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207610|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
208938|NCT01532128|O2|Outcome|Rasagiline 1 h After BIA 9-1067|Rasagiline 1 h after BIA 9-1067.
207611|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207612|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207613|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207614|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207615|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207616|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207617|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207618|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207619|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207620|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207621|NCT01536379|E2|Reported Event|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207622|NCT01536379|E1|Reported Event|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
207623|NCT01536366|B3|Baseline|Total|Total of all reporting groups
207624|NCT01536366|B2|Baseline|Group 2|"Period 1: Repaglinide Period 2: BIA 9-1067 + repaglinide~BIA 9-1067: 25 mg BIA 9-1067 (single-dose)~Repaglinide: 0.5 mg repaglinide (single-dose)"
207625|NCT01536366|B1|Baseline|Group 1|"Period 1: BIA 9-1067 + repaglinide Period 2: Repaglinide~BIA 9-1067: 25 mg BIA 9-1067 (single-dose)~Repaglinide: 0.5 mg repaglinide (single-dose)"
207626|NCT01536366|P2|Participant Flow|Group 2|"Period 1: Repaglinide Period 2: BIA 9-1067 + repaglinide~BIA 9-1067: 25 mg BIA 9-1067 (single-dose)~Repaglinide: 0.5 mg repaglinide (single-dose)"
207627|NCT01536366|P1|Participant Flow|Group 1|"Period 1: BIA 9-1067 + repaglinide Period 2: Repaglinide~BIA 9-1067: 25 mg BIA 9-1067 (single-dose)~Repaglinide: 0.5 mg repaglinide (single-dose)"
207628|NCT01536366|O2|Outcome|Repaglinide|Repaglinide 0.5 mg
207629|NCT01536366|O1|Outcome|BIA 9-1067 + Repaglinide|BIA 9-1067 25 mg Repaglinide 0.5 mg
207630|NCT01536366|O2|Outcome|Repaglinide|Repaglinide 0.5 mg
207631|NCT01536366|O1|Outcome|BIA 9-1067 + Repaglinide|BIA 9-1067 25 mg Repaglinide 0.5 mg
207632|NCT01536366|O2|Outcome|Repaglinide|Repaglinide 0.5 mg
207633|NCT01536366|O1|Outcome|BIA 9-1067 + Repaglinide|BIA 9-1067 25 mg Repaglinide 0.5 mg
207634|NCT01536366|O2|Outcome|Repaglinide|Repaglinide 0.5 mg
207635|NCT01536366|O1|Outcome|BIA 9-1067 + Repaglinide|BIA 9-1067 25 mg Repaglinide 0.5 mg
207636|NCT01536366|E2|Reported Event|Repaglinide|Repaglinide 0.5 mg
207637|NCT01536366|E1|Reported Event|BIA 9-1067 + Repaglinide|BIA 9-1067 25 mg Repaglinide 0.5 mg
207638|NCT01536262|B4|Baseline|Total|Total of all reporting groups
207639|NCT01536262|B3|Baseline|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
207640|NCT01536262|B2|Baseline|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
207641|NCT01536262|B1|Baseline|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
207714|NCT01536145|O10|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
207642|NCT01536262|P3|Participant Flow|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
207643|NCT01536262|P2|Participant Flow|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
207644|NCT01536262|P1|Participant Flow|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
207645|NCT01536262|O3|Outcome|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
207646|NCT01536262|O2|Outcome|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
207647|NCT01536262|O1|Outcome|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
207648|NCT01536262|O3|Outcome|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
207649|NCT01536262|O2|Outcome|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
207650|NCT01536262|O1|Outcome|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
207651|NCT01536262|O3|Outcome|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
207652|NCT01536262|O2|Outcome|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
207653|NCT01536262|O1|Outcome|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
207654|NCT01536262|E3|Reported Event|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
207655|NCT01536262|E2|Reported Event|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
207656|NCT01536262|E1|Reported Event|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
207657|NCT01536197|B3|Baseline|Total|Total of all reporting groups
207658|NCT01536197|B2|Baseline|Gastric Banding|"morbidly obese subjects undergoing laparoscopic gastric banding surgery~Gastric banding: Laparoscopic adjustable gastric banding"
207659|NCT01536197|B1|Baseline|Gastric Bypass|"morbidly obese subjects undergoing gastric bypass surgery~Gastric bypass: Roux-en-Y gastric bypass"
207660|NCT01536197|P2|Participant Flow|Gastric Banding|"morbidly obese subjects undergoing laparoscopic gastric banding surgery~Gastric banding: Laparoscopic adjustable gastric banding"
207661|NCT01536197|P1|Participant Flow|Gastric Bypass|"morbidly obese subjects undergoing gastric bypass surgery~Gastric bypass: Roux-en-Y gastric bypass"
207662|NCT01536197|O2|Outcome|Gastric Banding|"morbidly obese subjects undergoing laparoscopic gastric banding surgery~Gastric banding: Laparoscopic adjustable gastric banding"
207663|NCT01536197|O1|Outcome|Gastric Bypass|"morbidly obese subjects undergoing gastric bypass surgery~Gastric bypass: Roux-en-Y gastric bypass"
207664|NCT01536197|O2|Outcome|Gastric Banding|"morbidly obese subjects undergoing laparoscopic gastric banding surgery~Gastric banding: Laparoscopic adjustable gastric banding"
207665|NCT01536197|O1|Outcome|Gastric Bypass|"morbidly obese subjects undergoing gastric bypass surgery~Gastric bypass: Roux-en-Y gastric bypass"
207666|NCT01536197|E2|Reported Event|Gastric Banding|"morbidly obese subjects undergoing laparoscopic gastric banding surgery~Gastric banding: Laparoscopic adjustable gastric banding"
207667|NCT01536197|E1|Reported Event|Gastric Bypass|"morbidly obese subjects undergoing gastric bypass surgery~Gastric bypass: Roux-en-Y gastric bypass"
207668|NCT01536184|B3|Baseline|Total|Total of all reporting groups
207669|NCT01536184|B2|Baseline|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
207670|NCT01536184|B1|Baseline|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
207671|NCT01536184|P2|Participant Flow|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
207711|NCT01536145|O2|Outcome|CP-751,871 0.05 mg/kg|CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207712|NCT01536145|O1|Outcome|CP-751,871 0.025 mg/kg|CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207713|NCT01536145|O11|Outcome|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
207672|NCT01536184|P1|Participant Flow|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
207673|NCT01536184|O2|Outcome|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
207674|NCT01536184|O1|Outcome|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
207675|NCT01536184|O2|Outcome|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
207676|NCT01536184|O1|Outcome|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
207677|NCT01536184|O2|Outcome|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
207678|NCT01536184|O1|Outcome|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
207679|NCT01536184|O2|Outcome|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
207680|NCT01536184|O1|Outcome|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
207681|NCT01536184|O2|Outcome|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
207682|NCT01536184|O1|Outcome|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
207683|NCT01536184|E2|Reported Event|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
207684|NCT01536184|E1|Reported Event|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
207685|NCT01536171|B1|Baseline|Mid-Forefoot Striking in Shod Versus Barefoot Runners|trained runners (men,women) with a FM strike (verified in the lab)
207686|NCT01536171|P1|Participant Flow|Mid-Forefoot Striking in Shod Versus Barefoot Runners|trained runners (men,women) with a FM strike (verified in the lab)
207687|NCT01536171|O1|Outcome|Mid-Forefoot Striking in Shod Versus Barefoot Runners|two running conditions, with normal running shoes and barefoot
207688|NCT01536171|O1|Outcome|Mid-Forefoot Striking in Shod Versus Barefoot Runners|trained runners (men,women) with a FM strike (verified in the lab)
207689|NCT01536171|E1|Reported Event|Mid-Forefoot Striking in Shod Versus Barefoot Runners|trained runners (men,women) with a FM strike (verified in the lab)
207690|NCT01536145|B1|Baseline|CP-751,871|CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
207691|NCT01536145|P11|Participant Flow|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
207692|NCT01536145|P10|Participant Flow|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
207693|NCT01536145|P9|Participant Flow|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207694|NCT01536145|P8|Participant Flow|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
207695|NCT01536145|P7|Participant Flow|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207696|NCT01536145|P6|Participant Flow|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207697|NCT01536145|P5|Participant Flow|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207698|NCT01536145|P4|Participant Flow|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207699|NCT01536145|P3|Participant Flow|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207700|NCT01536145|P2|Participant Flow|CP-751,871 0.05 mg/kg|CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207701|NCT01536145|P1|Participant Flow|CP-751,871 0.025 mg/kg|CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207702|NCT01536145|O11|Outcome|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
207703|NCT01536145|O10|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
207704|NCT01536145|O9|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207705|NCT01536145|O8|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
207706|NCT01536145|O7|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207707|NCT01536145|O6|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207708|NCT01536145|O5|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207709|NCT01536145|O4|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207710|NCT01536145|O3|Outcome|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207715|NCT01536145|O9|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207716|NCT01536145|O8|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
207717|NCT01536145|O7|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207718|NCT01536145|O6|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207719|NCT01536145|O5|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207720|NCT01536145|O4|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207721|NCT01536145|O3|Outcome|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207722|NCT01536145|O2|Outcome|CP-751,871 0.05 mg/kg|CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207723|NCT01536145|O1|Outcome|CP-751,871 0.025 mg/kg|CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207724|NCT01536145|O1|Outcome|CP-751,871 0.025-20 mg/kg|CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
207725|NCT01536145|O1|Outcome|CP-751,871 0.025-20 mg/kg|CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
207726|NCT01536145|O11|Outcome|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
207727|NCT01536145|O10|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
207728|NCT01536145|O9|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207729|NCT01536145|O8|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
207730|NCT01536145|O7|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207731|NCT01536145|O6|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207732|NCT01536145|O5|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207733|NCT01536145|O4|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207734|NCT01536145|O3|Outcome|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207735|NCT01536145|O2|Outcome|CP-751,871 0.05 mg/kg|CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207736|NCT01536145|O1|Outcome|CP-751,871 0.025 mg/kg|CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207737|NCT01536145|O11|Outcome|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
207738|NCT01536145|O10|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
207739|NCT01536145|O9|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207740|NCT01536145|O8|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
207741|NCT01536145|O7|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207866|NCT01536015|P1|Participant Flow|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
207742|NCT01536145|O6|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207743|NCT01536145|O5|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207744|NCT01536145|O4|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207745|NCT01536145|O3|Outcome|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207746|NCT01536145|O2|Outcome|CP-751,871 0.05 mg/kg|CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207747|NCT01536145|O1|Outcome|CP-751,871 0.025 mg/kg|CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207748|NCT01536145|O7|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
207749|NCT01536145|O6|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207750|NCT01536145|O5|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
207751|NCT01536145|O4|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207752|NCT01536145|O3|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207753|NCT01536145|O2|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207754|NCT01536145|O1|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207755|NCT01536145|O7|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
207756|NCT01536145|O6|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207757|NCT01536145|O5|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
207758|NCT01536145|O4|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207759|NCT01536145|O3|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207760|NCT01536145|O2|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207761|NCT01536145|O1|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207762|NCT01536145|O7|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
207763|NCT01536145|O6|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207764|NCT01536145|O5|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
207765|NCT01536145|O4|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207766|NCT01536145|O3|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207767|NCT01536145|O2|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207768|NCT01536145|O1|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207769|NCT01536145|O7|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
207770|NCT01536145|O6|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
208939|NCT01532128|O1|Outcome|Rasagiline Alone|Rasagiline alone.
207771|NCT01536145|O5|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
207772|NCT01536145|O4|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207773|NCT01536145|O3|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207774|NCT01536145|O2|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207775|NCT01536145|O1|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207776|NCT01536145|O7|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
207777|NCT01536145|O6|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207778|NCT01536145|O5|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
207779|NCT01536145|O4|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207780|NCT01536145|O3|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207781|NCT01536145|O2|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207782|NCT01536145|O1|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207783|NCT01536145|O9|Outcome|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
207784|NCT01536145|O8|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
207785|NCT01536145|O7|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207786|NCT01536145|O6|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
207787|NCT01536145|O5|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207788|NCT01536145|O4|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207789|NCT01536145|O3|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207790|NCT01536145|O2|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207791|NCT01536145|O1|Outcome|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207792|NCT01536145|O11|Outcome|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
207793|NCT01536145|O10|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
207794|NCT01536145|O9|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207795|NCT01536145|O8|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
207796|NCT01536145|O7|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207797|NCT01536145|O6|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207798|NCT01536145|O5|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207799|NCT01536145|O4|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
208059|NCT01535222|O4|Outcome|Cohort 4|loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
207800|NCT01536145|O3|Outcome|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207801|NCT01536145|O2|Outcome|CP-751,871 0.05 mg/kg|CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207802|NCT01536145|O1|Outcome|CP-751,871 0.025 mg/kg|CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
207803|NCT01536145|O1|Outcome|CP-751,871 0.025-20 mg/kg|CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
207804|NCT01536145|E1|Reported Event|CP-751,871|CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks) (adverse events from all dosing groups were combined as a whole)
207805|NCT01536119|B3|Baseline|Total|Total of all reporting groups
207806|NCT01536119|B2|Baseline|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
207807|NCT01536119|B1|Baseline|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
207808|NCT01536119|P2|Participant Flow|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
207809|NCT01536119|P1|Participant Flow|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
207810|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
207811|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
207812|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
207813|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
207814|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
207815|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
207816|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
207817|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
207818|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
207819|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
207820|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
207821|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
207822|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
207823|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
207824|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
207825|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
207826|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
207827|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
207828|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
207829|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
207830|NCT01536119|E2|Reported Event|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
207952|NCT01535638|O1|Outcome|Deleobuvir Trial Formulation II|"Trial formulation II film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
207831|NCT01536119|E1|Reported Event|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
207832|NCT01536093|B3|Baseline|Total|Total of all reporting groups
207833|NCT01536093|B2|Baseline|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
207834|NCT01536093|B1|Baseline|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
207835|NCT01536093|P2|Participant Flow|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
207836|NCT01536093|P1|Participant Flow|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
207837|NCT01536093|O2|Outcome|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
207838|NCT01536093|O1|Outcome|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
207839|NCT01536093|O2|Outcome|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
207840|NCT01536093|O1|Outcome|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
207841|NCT01536093|O2|Outcome|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
207842|NCT01536093|O1|Outcome|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
207843|NCT01536093|O2|Outcome|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
207844|NCT01536093|O1|Outcome|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
207845|NCT01536093|O2|Outcome|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
207846|NCT01536093|O1|Outcome|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
207847|NCT01536093|O2|Outcome|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
207848|NCT01536093|O1|Outcome|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
207849|NCT01536093|E2|Reported Event|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
207850|NCT01536093|E1|Reported Event|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
207851|NCT01536067|B1|Baseline|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
207852|NCT01536067|P1|Participant Flow|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
207867|NCT01536015|O2|Outcome|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
207868|NCT01536015|O1|Outcome|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
208940|NCT01532128|E4|Reported Event|Rasagiline Concomitant BIA 9-1067|
207853|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
207854|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
207855|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
207856|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
207857|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
207858|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
207859|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
207860|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
207861|NCT01536067|E1|Reported Event|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
207862|NCT01536015|B3|Baseline|Total|Total of all reporting groups
207863|NCT01536015|B2|Baseline|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
207864|NCT01536015|B1|Baseline|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
207865|NCT01536015|P2|Participant Flow|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
207869|NCT01536015|O2|Outcome|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
207870|NCT01536015|O1|Outcome|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
207871|NCT01536015|O2|Outcome|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
207872|NCT01536015|O1|Outcome|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
207873|NCT01536015|O2|Outcome|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
207874|NCT01536015|O1|Outcome|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
207875|NCT01536015|O2|Outcome|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
207876|NCT01536015|O1|Outcome|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
207877|NCT01536015|O2|Outcome|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
207878|NCT01536015|O1|Outcome|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
207879|NCT01536015|E2|Reported Event|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
207880|NCT01536015|E1|Reported Event|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
207881|NCT01535976|B3|Baseline|Total|Total of all reporting groups
207882|NCT01535976|B2|Baseline|Placebo|"normal saline infusion~Placebo : Placebo Comparator: Placebo~normal saline infusion along with propofol 100 mcg/kg/min"
207883|NCT01535976|B1|Baseline|Ketamine|"Infusion of ketamine~Ketamine : Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case along with propofol 100 mcg/kg/min"
207884|NCT01535976|P2|Participant Flow|Placebo|".9 normal saline infusion~Placebo : Placebo Comparator: Placebo~.9 normal saline infusion"
207885|NCT01535976|P1|Participant Flow|Ketamine|"Infusion of ketamine~Ketamine : Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case"
207886|NCT01535976|O2|Outcome|Placebo|"normal saline infusion~Placebo : Placebo Comparator: Placebo~normal saline infusion along with propofol 100 mcg/kg/min"
207887|NCT01535976|O1|Outcome|Ketamine|"Infusion of ketamine~Ketamine : Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case along with propofol 100 mcg/kg/min."
207888|NCT01535976|E2|Reported Event|Placebo|".9 normal saline infusion~Placebo : Placebo Comparator: Placebo~.9 normal saline infusion"
207889|NCT01535976|E1|Reported Event|Ketamine|"Infusion of ketamine~Ketamine : Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case"
207890|NCT01535807|B3|Baseline|Total|Total of all reporting groups
207891|NCT01535807|B2|Baseline|Control|"The control No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
207892|NCT01535807|B1|Baseline|CorMatrix Group|"The treatment Cormatrix group will receive the CorMatrix EMC during surgery for the closure of the pericardium according to the specific recommended surgical technique.~CorMatrix extra cellular matrix (ECM): - Cormatrix ECM group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique.~- No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
207893|NCT01535807|P2|Participant Flow|Control|"The control No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
207894|NCT01535807|P1|Participant Flow|CorMatrix Group|"The treatment Cormatrix group will receive the CorMatrix EMC during surgery for the closure of the pericardium according to the specific recommended surgical technique.~CorMatrix extra cellular matrix (ECM): - Cormatrix ECM group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique.~- No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
207895|NCT01535807|O2|Outcome|Control|"The control No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
207896|NCT01535807|O1|Outcome|CorMatrix Group|"The treatment Cormatrix group will receive the CorMatrix EMC during surgery for the closure of the pericardium according to the specific recommended surgical technique.~CorMatrix extra cellular matrix (ECM): - Cormatrix ECM group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique.~- No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
207897|NCT01535807|E2|Reported Event|Control|"The control No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
207898|NCT01535807|E1|Reported Event|CorMatrix Group|"The treatment Cormatrix group will receive the CorMatrix EMC during surgery for the closure of the pericardium according to the specific recommended surgical technique.~CorMatrix extra cellular matrix (ECM): - Cormatrix ECM group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique.~- No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
207953|NCT01535638|E4|Reported Event|Deleobuvir (Total)|All subjects while on treatment with Deleobuvir, i.e. there is no distinction between the 3 formulations.
207899|NCT01535729|B1|Baseline|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207900|NCT01535729|P1|Participant Flow|Non-small Cell Lung Cancer (NSCLC) Elderly Participants|Elderly Participants (greater than or equal to [≥] 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207901|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207902|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207903|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207904|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207905|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207906|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207907|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207908|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207909|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207910|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207911|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207912|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207913|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207914|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207915|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207916|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207917|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207918|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207919|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207920|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207921|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207922|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207923|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207924|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207925|NCT01535729|E1|Reported Event|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
207926|NCT01535664|B1|Baseline|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
207927|NCT01535664|P1|Participant Flow|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
207928|NCT01535664|O2|Outcome|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
207929|NCT01535664|O1|Outcome|Dalfampridine-ER Withdrawn|
207930|NCT01535664|O2|Outcome|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
207931|NCT01535664|O1|Outcome|Dalfampridine-ER Withdrawn|
207932|NCT01535664|O2|Outcome|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
207933|NCT01535664|O1|Outcome|Dalfampridine-ER Withdrawn|
207934|NCT01535664|O2|Outcome|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
207935|NCT01535664|O1|Outcome|Dalfampridine-ER Withdrawn|
207936|NCT01535664|O2|Outcome|Dalfampridine-ER 10 mg|
207937|NCT01535664|O1|Outcome|Dalfampridine-ER Withdrawn|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
207938|NCT01535664|E2|Reported Event|Dalfampridine-ER Withdrawn|
207939|NCT01535664|E1|Reported Event|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
207940|NCT01535638|B1|Baseline|All Subjects|This study was conducted in healthy male subjects as open-label, single-dose, randomised three-way crossover trial to investigate relative bioavailability. Each subject was planned to receive all 3 treatments in a randomly assigned order. The treatments were 3 single doses of 600 mg (3 film-coated tablets à 200 mg each) of Deleobuvir, either as TF II (trial formulation 2) formulation, FF (final formulation) formulation or as FF modified formulation.
207941|NCT01535638|P6|Participant Flow|Final Formulation (FF) Modified / FF / Trial Formulation II|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Final Formulation modified, Final Formulation and Trial Formulation II. There was a wash out period of at least 6 days between each drug administration.
207942|NCT01535638|P5|Participant Flow|Final Formulation (FF) Modified / Trial Formulation II / FF|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Final Formulation modified, Trial Formulation II and Final Formulation. There was a wash out period of at least 6 days between each drug administration.
207943|NCT01535638|P4|Participant Flow|Final Formulation (FF) / FF Modified / Trial Formulation II|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Final Formulation, Final Formulation modified and Trial Formulation II. There was a wash out period of at least 6 days between each drug administration.
207944|NCT01535638|P3|Participant Flow|Final Formulation (FF) / Trial Formulation II / FF Modified|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Final Formulation, Trial Formulation II and Final Formulation modified. There was a wash out period of at least 6 days between each drug administration.
207945|NCT01535638|P2|Participant Flow|Trial Formulation II / Final Formulation (FF) Modified / FF|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Trial Formulation II, Final Formulation modified and Final Formulation. There was a wash out period of at least 6 days between each drug administration.
207946|NCT01535638|P1|Participant Flow|Trial Formulation II / Final Formulation (FF) / FF Modified|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Trial Formulation (TF) II, Final Formulation (FF) and FF modified. There was a wash out period of at least 6 days between each drug administration.
207947|NCT01535638|O3|Outcome|Deleobuvir Final Formulation Modified|"Final formulation modified film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
207948|NCT01535638|O2|Outcome|Deleobuvir Final Formulation|"Final formulation film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
207949|NCT01535638|O1|Outcome|Deleobuvir Trial Formulation II|"Trial formulation II film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
207950|NCT01535638|O3|Outcome|Deleobuvir Final Formulation Modified|"Final formulation modified film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
207951|NCT01535638|O2|Outcome|Deleobuvir Final Formulation|"Final formulation film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
208057|NCT01535222|O6|Outcome|Placebo|commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
207954|NCT01535638|E3|Reported Event|Deleobuvir Final Formulation Modified|"Final formulation modified film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
207955|NCT01535638|E2|Reported Event|Deleobuvir Final Formulation|"Final formulation film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
207956|NCT01535638|E1|Reported Event|Deleobuvir Trial Formulation II|"Trial formulation II film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
207957|NCT01535599|B3|Baseline|Total|Total of all reporting groups
207958|NCT01535599|B2|Baseline|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
207959|NCT01535599|B1|Baseline|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
207960|NCT01535599|P2|Participant Flow|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
207961|NCT01535599|P1|Participant Flow|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
207962|NCT01535599|O2|Outcome|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
207963|NCT01535599|O1|Outcome|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
207964|NCT01535599|O2|Outcome|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
207965|NCT01535599|O1|Outcome|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
207966|NCT01535599|O2|Outcome|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
207967|NCT01535599|O1|Outcome|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
207968|NCT01535599|E2|Reported Event|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
207969|NCT01535599|E1|Reported Event|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
207970|NCT01535560|B3|Baseline|Total|Total of all reporting groups
207971|NCT01535560|B2|Baseline|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
207972|NCT01535560|B1|Baseline|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
207973|NCT01535560|P2|Participant Flow|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
207974|NCT01535560|P1|Participant Flow|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
207975|NCT01535560|O2|Outcome|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
207976|NCT01535560|O1|Outcome|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
207977|NCT01535560|O2|Outcome|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
207978|NCT01535560|O1|Outcome|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
207979|NCT01535560|O2|Outcome|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
207980|NCT01535560|O1|Outcome|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
207981|NCT01535560|E2|Reported Event|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
207982|NCT01535560|E1|Reported Event|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
207983|NCT01535365|B3|Baseline|Total|Total of all reporting groups
207984|NCT01535365|B2|Baseline|Cold|Application of cold to muscle sprain.
207985|NCT01535365|B1|Baseline|Heat|Application of Heat to site of muscle sprain.
207986|NCT01535365|P2|Participant Flow|Cold|Application of cold to muscle sprain.
207987|NCT01535365|P1|Participant Flow|Heat|Application of Heat to site of muscle sprain.
207988|NCT01535365|O2|Outcome|Cold|Application of cold to muscle sprain.
207989|NCT01535365|O1|Outcome|Heat|Application of heat to site of muscle sprain.
207990|NCT01535365|O2|Outcome|Ice Pack|Application of cold to muscle sprain.
207991|NCT01535365|O1|Outcome|Heat Pack|Application of Heat to site of muscle sprain.
207992|NCT01535365|E2|Reported Event|Cold|Application of cold to muscle sprain.
207993|NCT01535365|E1|Reported Event|Heat|Application of Heat to site of muscle sprain.
207994|NCT01535326|B4|Baseline|Total|Total of all reporting groups
207995|NCT01535326|B3|Baseline|Water Exchange|"infuse and remove water during insertion phase of colonoscopy~water exchange: infuse and remove water during insertion phase of colonoscopy"
207996|NCT01535326|B2|Baseline|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy~water immersion: infuse water during insertion, aspirate water during withdrawal"
207997|NCT01535326|B1|Baseline|Air Insufflation|"Use air insufflation during colonoscopy~air insufflation: insufflate air during the insertion of colonoscopy"
207998|NCT01535326|P3|Participant Flow|Water Exchange|"infuse and remove water during insertion phase of colonoscopy~water exchange: infuse and remove water during insertion phase of colonoscopy"
207999|NCT01535326|P2|Participant Flow|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy~water immersion: infuse water during insertion, aspirate water during withdrawal"
208000|NCT01535326|P1|Participant Flow|Air Insufflation|"Use air insufflation during colonoscopy~air insufflation: insufflate air during the insertion of colonoscopy"
208001|NCT01535326|O3|Outcome|Water Exchange|"infuse and remove water during insertion phase of colonoscopy~water exchange: infuse and remove water during insertion phase of colonoscopy"
208002|NCT01535326|O2|Outcome|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy~water immersion: infuse water during insertion, aspirate water during withdrawal"
208003|NCT01535326|O1|Outcome|Air Insufflation|"Use air insufflation during colonoscopy~air insufflation: insufflate air during the insertion of colonoscopy"
208004|NCT01535326|O3|Outcome|Water Exchange|"infuse and remove water during insertion phase of colonoscopy~water exchange: infuse and remove water during insertion phase of colonoscopy"
208941|NCT01532128|E3|Reported Event|Rasagiline 1 h After BIA 9-1067|
208005|NCT01535326|O2|Outcome|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy~water immersion: infuse water during insertion, aspirate water during withdrawal"
208006|NCT01535326|O1|Outcome|Air Insufflation|"Use air insufflation during colonoscopy~air insufflation: insufflate air during the insertion of colonoscopy"
208007|NCT01535326|O3|Outcome|Water Exchange|"infuse and remove water during insertion phase of colonoscopy~water exchange: infuse and remove water during insertion phase of colonoscopy"
208008|NCT01535326|O2|Outcome|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy~water immersion: infuse water during insertion, aspirate water during withdrawal"
208009|NCT01535326|O1|Outcome|Air Insufflation|"Use air insufflation during colonoscopy~air insufflation: insufflate air during the insertion of colonoscopy"
208010|NCT01535326|O3|Outcome|Water Exchange|"infuse and remove water during insertion phase of colonoscopy~water exchange: infuse and remove water during insertion phase of colonoscopy~Proportion of no pain: 61.1%"
208011|NCT01535326|O2|Outcome|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy~water immersion: infuse water during insertion, aspirate water during withdrawal~Proportion of no pain: 43.3%"
208012|NCT01535326|O1|Outcome|Air Insufflation|"Use air insufflation during colonoscopy~air insufflation: insufflate air during the insertion of colonoscopy~Proportion of no pain: 30%"
208013|NCT01535326|E3|Reported Event|Water Exchange|"infuse and remove water during insertion phase of colonoscopy~water exchange: infuse and remove water during insertion phase of colonoscopy"
208014|NCT01535326|E2|Reported Event|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy~water immersion: infuse water during insertion, aspirate water during withdrawal"
208015|NCT01535326|E1|Reported Event|Air Insufflation|"Use air insufflation during colonoscopy~air insufflation: insufflate air during the insertion of colonoscopy"
208016|NCT01535261|B1|Baseline|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
208017|NCT01535261|P1|Participant Flow|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
208018|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
208019|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
208020|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
208021|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
208022|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
208023|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
208024|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
208025|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
208026|NCT01535261|E1|Reported Event|Ranibizumab 0.5mg|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
208027|NCT01535235|B3|Baseline|Total|Total of all reporting groups
208028|NCT01535235|B2|Baseline|Placebo|"Placebo group~Placebo: Placebo Daily x24wks"
208029|NCT01535235|B1|Baseline|ACE Inhibitor|"Active group~Lisinopril: Lisinopril 20mg Daily x 24 weeks"
208030|NCT01535235|P2|Participant Flow|Placebo|"Placebo group~Placebo: Placebo QD x24wks"
208031|NCT01535235|P1|Participant Flow|ACE Inhibitor|"Active group~Lisinopril: Lisinopril 20mg QD x 24 weeks"
208032|NCT01535235|O2|Outcome|Placebo|"Placebo group~Placebo: Placebo QD x24wks"
208033|NCT01535235|O1|Outcome|ACE Inhibitor|"Active group~Lisinopril: Lisinopril 20mg QD x 24 weeks"
208034|NCT01535235|O2|Outcome|Placebo|"Placebo group~Placebo: Placebo QD x24wks"
208035|NCT01535235|O1|Outcome|ACE Inhibitor|"Active group~Lisinopril: Lisinopril 20mg QD x 24 weeks"
208036|NCT01535235|E2|Reported Event|Placebo|"Placebo group~Placebo: Placebo QD x24wks"
208037|NCT01535235|E1|Reported Event|ACE Inhibitor|"Active group~Lisinopril: Lisinopril 20mg QD x 24 weeks"
208038|NCT01535222|B7|Baseline|Total|Total of all reporting groups
208039|NCT01535222|B6|Baseline|Placebo|commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
208040|NCT01535222|B5|Baseline|Cohort 5|loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
208041|NCT01535222|B4|Baseline|Cohort 4|loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
208042|NCT01535222|B3|Baseline|Cohort 3|loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
208043|NCT01535222|B2|Baseline|Cohort 2|loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
208044|NCT01535222|B1|Baseline|Cohort 1|loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
208045|NCT01535222|P6|Participant Flow|Placebo|commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
208046|NCT01535222|P5|Participant Flow|Cohort 5|loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
208047|NCT01535222|P4|Participant Flow|Cohort 4|loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
208048|NCT01535222|P3|Participant Flow|Cohort 3|loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
208049|NCT01535222|P2|Participant Flow|Cohort 2|loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
208050|NCT01535222|P1|Participant Flow|Cohort 1|loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
208051|NCT01535222|O6|Outcome|Placebo|commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
208052|NCT01535222|O5|Outcome|Cohort 5|loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
208053|NCT01535222|O4|Outcome|Cohort 4|loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
208054|NCT01535222|O3|Outcome|Cohort 3|loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
208055|NCT01535222|O2|Outcome|Cohort 2|loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
208056|NCT01535222|O1|Outcome|Cohort 1|loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
208942|NCT01532128|E2|Reported Event|Rasagiline Alone|
208060|NCT01535222|O3|Outcome|Cohort 3|loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
208061|NCT01535222|O2|Outcome|Cohort 2|loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
208062|NCT01535222|O1|Outcome|Cohort 1|loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
208063|NCT01535222|E6|Reported Event|Placebo|commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
208064|NCT01535222|E5|Reported Event|Cohort 5|loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
208065|NCT01535222|E4|Reported Event|Cohort 4|loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
208066|NCT01535222|E3|Reported Event|Cohort 3|loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
208067|NCT01535222|E2|Reported Event|Cohort 2|loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
208068|NCT01535222|E1|Reported Event|Cohort 1|loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
208069|NCT01535118|B1|Baseline|Adults and Children With ARC|Adults and children with ARC who complete the survey
208070|NCT01535118|P1|Participant Flow|Adults and Children With Allergic Rhinoconjunctivitis (ARC)|Adults and children with ARC who complete the survey
208071|NCT01535118|O1|Outcome|Adults and Children With ARC|Adults and children with ARC who complete the survey
208072|NCT01535118|O1|Outcome|Adults and Children With ARC|Adults and children with ARC who complete the survey
208073|NCT01535118|O1|Outcome|Adults and Children With ARC|Adults and children with ARC who complete the survey
208074|NCT01535118|O1|Outcome|Adults and Children With ARC|Adults and children with ARC who complete the survey
208075|NCT01535118|O1|Outcome|Adults and Children With ARC|Adults and children with ARC who complete the survey
208076|NCT01535118|O1|Outcome|Adults and Children With ARC|Adults and children with ARC who complete the survey
208077|NCT01535118|E1|Reported Event|Adults and Children With ARC|Adults and children with ARC who complete the survey
208078|NCT01535040|B3|Baseline|Total|Total of all reporting groups
208079|NCT01535040|B2|Baseline|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.~placebo: Placebo by mouth through completion of 12 weeks."
208080|NCT01535040|B1|Baseline|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.~memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
208081|NCT01535040|P2|Participant Flow|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.~placebo: Placebo by mouth through completion of 12 weeks."
208082|NCT01535040|P1|Participant Flow|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.~memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
208083|NCT01535040|O2|Outcome|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.~placebo: Placebo by mouth through completion of 12 weeks."
208084|NCT01535040|O1|Outcome|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.~memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
208085|NCT01535040|O2|Outcome|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.~placebo: Placebo by mouth through completion of 12 weeks."
208086|NCT01535040|O1|Outcome|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.~memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
208087|NCT01535040|O2|Outcome|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.~placebo: Placebo by mouth through completion of 12 weeks."
208088|NCT01535040|O1|Outcome|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.~memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
208089|NCT01535040|O2|Outcome|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.~placebo: Placebo by mouth through completion of 12 weeks."
208090|NCT01535040|O1|Outcome|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.~memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
208091|NCT01535040|E2|Reported Event|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.~placebo: Placebo by mouth through completion of 12 weeks."
208092|NCT01535040|E1|Reported Event|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.~memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
208093|NCT01535001|B3|Baseline|Total|Total of all reporting groups
208094|NCT01535001|B2|Baseline|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
208120|NCT01534975|B3|Baseline|Iopamidol 370|"group 3 will receive iopamidol 370 as the contrast agent during CT acquisition. this will reflect the intervention of that arm, by testing the diagnostic ability of this contrast agent to perform cardiac CT angiography"
208175|NCT01534910|P2|Participant Flow|Aged Garlic Extract|"2400 mg of aged garlic extract~aged garlic extract: 2400 mg a day"
208176|NCT01534910|P1|Participant Flow|Sugar Pill|"placebo~placebo: placebo"
208095|NCT01535001|B1|Baseline|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
208096|NCT01535001|P2|Participant Flow|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
208097|NCT01535001|P1|Participant Flow|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
208098|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
208099|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
208100|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
208101|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
208102|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
208103|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
208104|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
208105|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
208106|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
208173|NCT01534910|B2|Baseline|Aged Garlic Extract|"2400 mg of aged garlic extract~aged garlic extract: 2400 mg a day patients randomized to aged garlic extract"
208107|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
208108|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
208109|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
208110|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
208111|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
208112|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
208113|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
208114|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
208115|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
208116|NCT01535001|E2|Reported Event|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
208117|NCT01535001|E1|Reported Event|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
208118|NCT01534975|B5|Baseline|Total|Total of all reporting groups
208119|NCT01534975|B4|Baseline|Iodixanol 270|"group 4 will receive iodixanol 270 as the contrast agent during CT acquisition. this will reflect the intervention of that arm, by testing the diagnostic ability of this contrast agent to perform cardiac CT angiography"
208174|NCT01534910|B1|Baseline|Sugar Pill|"placebo~placebo: placebo patients were randomized to placebo"
208121|NCT01534975|B2|Baseline|Iohexol 350|"group 2 will receive iohexol 350 as the contrast agent during CT acquisition. this will reflect the intervention of that arm, by testing the diagnostic ability of this contrast agent to perform cardiac CT angiography"
208122|NCT01534975|B1|Baseline|Iodixanol 320|"group 1 will receive iodixanol 320 as the contrast agent during CT acquisition. this will reflect the intervention of that arm, by testing the diagnostic ability of this contrast agent to perform cardiac CT angiography"
208123|NCT01534975|P4|Participant Flow|Iodixanol 270|group 4 iodixanol 270
208124|NCT01534975|P3|Participant Flow|Iopamidol 370|group 3 iopamidol 370
208125|NCT01534975|P2|Participant Flow|Iohexol 350|group 2 iohexol 350
208126|NCT01534975|P1|Participant Flow|Iodixanol 320|group 1 Iodixanol 320
208127|NCT01534975|O4|Outcome|Iodixanol 270|group 4
208128|NCT01534975|O3|Outcome|Iopamidol 370|group 3
208129|NCT01534975|O2|Outcome|Iohexol 350|group 2
208130|NCT01534975|O1|Outcome|Iodixanol 320|group 1
208131|NCT01534975|E4|Reported Event|Iodixanol 270|group 4 iodixanol 270
208132|NCT01534975|E3|Reported Event|Iopamidol 370|group 3 iopamidol 370
208133|NCT01534975|E2|Reported Event|Iohexol 350|group 2 iohexol 350
208134|NCT01534975|E1|Reported Event|Iodixanol 320|group 1 iodixanol 320
208135|NCT01534962|B5|Baseline|Total|Total of all reporting groups
208136|NCT01534962|B4|Baseline|Placebo|Placebo, oral, BID.
208137|NCT01534962|B3|Baseline|Ranolazin High Dose|Ranolazine, high dose, oral, BID
208138|NCT01534962|B2|Baseline|Ranolazine Intermediate Dose|Ranolazine, intermediate dose, oral, BID
208139|NCT01534962|B1|Baseline|Ranolazine Low Dose|Ranolazine, low dose, oral, BID
208140|NCT01534962|P4|Participant Flow|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
208141|NCT01534962|P3|Participant Flow|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
208142|NCT01534962|P2|Participant Flow|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
208143|NCT01534962|P1|Participant Flow|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
208144|NCT01534962|O4|Outcome|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
208145|NCT01534962|O3|Outcome|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
208146|NCT01534962|O2|Outcome|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
208147|NCT01534962|O1|Outcome|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
208148|NCT01534962|O4|Outcome|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
208149|NCT01534962|O3|Outcome|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
208150|NCT01534962|O2|Outcome|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
208151|NCT01534962|O1|Outcome|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
208152|NCT01534962|O4|Outcome|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
208153|NCT01534962|O3|Outcome|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
208154|NCT01534962|O2|Outcome|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
208155|NCT01534962|O1|Outcome|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
208156|NCT01534962|O4|Outcome|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
208157|NCT01534962|O3|Outcome|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
208158|NCT01534962|O2|Outcome|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
208159|NCT01534962|O1|Outcome|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
208160|NCT01534962|O4|Outcome|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
208161|NCT01534962|O3|Outcome|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
208162|NCT01534962|O2|Outcome|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
208163|NCT01534962|O1|Outcome|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
208164|NCT01534962|O4|Outcome|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
208165|NCT01534962|O3|Outcome|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
208166|NCT01534962|O2|Outcome|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
208167|NCT01534962|O1|Outcome|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
208168|NCT01534962|E4|Reported Event|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
208169|NCT01534962|E3|Reported Event|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
208170|NCT01534962|E2|Reported Event|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
208171|NCT01534962|E1|Reported Event|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
208172|NCT01534910|B3|Baseline|Total|Total of all reporting groups
208177|NCT01534910|O2|Outcome|Aged Garlic Extract|"2400 mg of aged garlic extract~aged garlic extract: 2400 mg a day"
208178|NCT01534910|O1|Outcome|Sugar Pill|"placebo~placebo: placebo"
208179|NCT01534910|O2|Outcome|Aged Garlic Extract|"2400 mg of aged garlic extract~aged garlic extract: 2400 mg a day patients randomized to aged garlic extract No adverse events"
208180|NCT01534910|O1|Outcome|Sugar Pill|"placebo~placebo: placebo patients were randomized to placebo No adverse events"
208181|NCT01534910|E2|Reported Event|Aged Garlic Extract|"2400 mg of aged garlic extract~aged garlic extract: 2400 mg a day patients randomized to aged garlic extract No adverse events"
208182|NCT01534910|E1|Reported Event|Sugar Pill|"placebo~placebo: placebo patients were randomized to placebo No adverse events"
208183|NCT01534897|B1|Baseline|GSK2118436|Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.
208184|NCT01534897|P1|Participant Flow|GSK2118436|"Note: This is a single arm feasibility study.~Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.~GSK2118436: 150mg twice per day orally for 28 days (42 days if Iodine-131 scan on Day 25 shows new uptake)"
208185|NCT01534897|O1|Outcome|GSK2118436|Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.
208186|NCT01534897|O1|Outcome|GSK2118436|"Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.~GSK2118436: 150mg twice per day orally for 28 days (42 days if Iodine-131 scan on Day 25 shows new uptake)"
208187|NCT01534897|O1|Outcome|GSK2118436|"Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.~GSK2118436: 150mg twice per day orally for 28 days (42 days if Iodine-131 scan on Day 25 shows new uptake)"
208188|NCT01534897|O1|Outcome|GSK2118436|Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.
208189|NCT01534897|O1|Outcome|GSK2118436|Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.
208190|NCT01534897|E1|Reported Event|GSK2118436|"Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.~GSK2118436: 150mg twice per day orally for 28 days (42 days if Iodine-131 scan on Day 25 shows new uptake)"
208191|NCT01534689|B1|Baseline|Erchonia FX-405™ Laser|"The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW~Erchonia FX-405™ Laser: The Erchonia FX-405™ dual diode laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time."
208192|NCT01534689|P1|Participant Flow|Erchonia FX-405™ Laser|The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
208193|NCT01534689|O1|Outcome|Erchonia FX-405™ Laser|The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
208194|NCT01534689|O1|Outcome|Erchonia FX-405™ Laser|The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
208195|NCT01534689|O1|Outcome|Erchonia FX-405™ Laser|The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
208196|NCT01534689|E1|Reported Event|Erchonia FX-405™ Laser|The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
208197|NCT01534676|B3|Baseline|Total|Total of all reporting groups
208943|NCT01532128|E1|Reported Event|Before Treatment|
208198|NCT01534676|B2|Baseline|Donors|Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
208199|NCT01534676|B1|Baseline|Recipients|Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.
208200|NCT01534676|P2|Participant Flow|Donors|Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
208201|NCT01534676|P1|Participant Flow|Recipients|Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.
208202|NCT01534676|O2|Outcome|Donors|Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
208203|NCT01534676|O1|Outcome|Recipients|Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.
208204|NCT01534676|E2|Reported Event|Donors|Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
208205|NCT01534676|E1|Reported Event|Recipients|Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.
208206|NCT01534637|B1|Baseline|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.~PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
208207|NCT01534637|P1|Participant Flow|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.~PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
208208|NCT01534637|O1|Outcome|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.~PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
208209|NCT01534637|O1|Outcome|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.~PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
208210|NCT01534637|O1|Outcome|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.~PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
208263|NCT01534416|P2|Participant Flow|Saline|Subjects injected paracervically with 10 ml of normal saline prior to surgical incision.
208264|NCT01534416|P1|Participant Flow|Bupivacaine|Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision.
208265|NCT01534416|O4|Outcome|Saline OTC Analgesics Use|
208266|NCT01534416|O3|Outcome|Bupivacaine OTC Analgesics Use|OTC - over-the-counter
208267|NCT01534416|O2|Outcome|Saline Narcotics Use|
208211|NCT01534637|E1|Reported Event|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.~PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
208212|NCT01534533|B5|Baseline|Total|Total of all reporting groups
208213|NCT01534533|B4|Baseline|Normal Lutein Group|subjects without early atherosclerosis
208214|NCT01534533|B3|Baseline|Lutein and Lycopene Group|lutein plus lycopene group
208215|NCT01534533|B2|Baseline|Lutein Group|20mg lutein per day
208216|NCT01534533|B1|Baseline|Placebo|starch in hard shell gelatine capsules
208217|NCT01534533|P4|Participant Flow|Normal Lutein Group|subjects without early atherosclerosis
208218|NCT01534533|P3|Participant Flow|Lutein and Lycopene Group|lutein plus lycopene group
208219|NCT01534533|P2|Participant Flow|Lutein Group|20mg lutein per day
208220|NCT01534533|P1|Participant Flow|Placebo|starch in hard shell gelatine capsules
208221|NCT01534533|O4|Outcome|Normal Lutein Control Group (NL Group)|subjects free from atherosclerosis received 20mg lutein
208222|NCT01534533|O3|Outcome|Combination Group (LL Group)|early atherosclerosis cases received 20mg lutein and 20mg lycopene
208223|NCT01534533|O2|Outcome|Lutein Group (L Group)|early atherosclerosis case received 20mg lutein
208224|NCT01534533|O1|Outcome|Placebo (P Group)|starch in hard shell gelatine capsules
208225|NCT01534533|O4|Outcome|Normal Lutein Control Group (NL Group)|subjects free from atherosclerosis received 20mg lutein
208226|NCT01534533|O3|Outcome|Lutein and Lycopene Group (LL Group)|received 20mg lutein and 20mg lycopene
208227|NCT01534533|O2|Outcome|Lutein Group (L Group)|early atherosclerosis case received 20mg lutein
208228|NCT01534533|O1|Outcome|Placebo (P Group)|starch in hard shell gelatine capsules
208229|NCT01534533|O4|Outcome|Normal Lutein Control Group (NL Group)|subjects free from atherosclerosis received 20mg lutein
208230|NCT01534533|O3|Outcome|Combination Group (LL Group)|received 20mg lutein and 20mg lycopene
208231|NCT01534533|O2|Outcome|Lutein Group (L Group)|early atherosclerosis case received 20mg lutein
208232|NCT01534533|O1|Outcome|Placebo (P Group)|starch in hard shell gelatine capsules
208233|NCT01534533|O4|Outcome|Normal Lutein Control Group (NL Group)|subjects free from atherosclerosis received 20mg lutein
208234|NCT01534533|O3|Outcome|Combination Group (LL Group)|received 20mg lutein and 20mg lycopene
208235|NCT01534533|O2|Outcome|Lutein Group (L Group)|early atherosclerosis case received 20mg lutein
208236|NCT01534533|O1|Outcome|Placebo (P Group)|starch in hard shell gelatine capsules
208237|NCT01534533|O4|Outcome|Normal Lutein Control Group (NL Group)|subjects free from atherosclerosis received 20mg lutein
208238|NCT01534533|O3|Outcome|Lutein and Lycopene Group (LL Group)|received 20mg lutein and 20mg lycopene
208239|NCT01534533|O2|Outcome|Lutein Group (L Group)|early atherosclerosis case received 20mg lutein
208240|NCT01534533|O1|Outcome|Placebo (P Group)|starch in hard shell gelatine capsules
208241|NCT01534533|E4|Reported Event|Normal Lutein Control Group|20mg lutein for subjects free from atherosclerosis, once a day
208242|NCT01534533|E3|Reported Event|Combination Group|early atherosclerosis cases, received 20mg lutein plus 20mg lycopene, once a day
208243|NCT01534533|E2|Reported Event|Lutein Group|early atherosclerosis cases, received 20mg lutein, once a day
208244|NCT01534533|E1|Reported Event|Placebo|early atherosclerosis cases, received starch in hard shell gelatine capsules, once a day
208245|NCT01534520|B3|Baseline|Total|Total of all reporting groups
208246|NCT01534520|B2|Baseline|Group 2: Intravaginal Placebo Gel|4mL placebo gel (K-Y Jelly) for vaginal self-administration
208247|NCT01534520|B1|Baseline|Group 1: Intravaginal 2% Lidocaine Gel|"4mL of 2% lidocaine gel for vaginal self-administration~)"
208248|NCT01534520|P2|Participant Flow|Group 2: Intravaginal Placebo Gel|Intravaginal insertion of 4ml of placebo gel (K-Y Jelly)
208249|NCT01534520|P1|Participant Flow|Group 1: Intravaginal 2% Lidocaine Gel|4 ml of 2% lidocaine gel for self vaginal insertion
208250|NCT01534520|O2|Outcome|Group 2: Intravaginal Placebo Gel|Intravaginal insertion of 4ml of placebo gel (K-Y Jelly)
208251|NCT01534520|O1|Outcome|Group 1: Intravaginal 2% Lidocaine Gel|4 ml of 2% lidocaine gel for self vaginal insertion
208252|NCT01534520|O2|Outcome|Group 2: Intravaginal Placebo Gel|"Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)~Placebo: KY Jelly"
208253|NCT01534520|O1|Outcome|Group 1: Intravaginal 2% Lidocaine Gel|"Intravaginal insertion of 4mL of 2% lidocaine gel~Lidocaine: Intravaginal insertion of 4mL 2% lidocaine gel"
208254|NCT01534520|O2|Outcome|Group 2: Intravaginal Placebo Gel|"Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)~Lidocaine: Intravaginal insertion of 5mL 2% lidocaine gel"
208255|NCT01534520|O1|Outcome|Group 1: Intravaginal 2% Lidocaine Gel|"Intravaginal insertion of 4mL of 2% lidocaine gel~Placebo: KY Jelly"
208256|NCT01534520|O2|Outcome|Group 2: Intravaginal Placebo Gel|"Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)~Lidocaine: Intravaginal insertion of 5mL 2% lidocaine gel"
208257|NCT01534520|O1|Outcome|Group 1: Intravaginal 2% Lidocaine Gel|"Intravaginal insertion of 4mL of 2% lidocaine gel~Placebo: KY Jelly"
208258|NCT01534520|E2|Reported Event|Study Drug|"Intravaginal insertion of 4mL 2% lidocaine gel~Lidocaine: Intravaginal insertion of 4mL 2% lidocaine gel"
208259|NCT01534520|E1|Reported Event|Placebo|"Intravaginal insertion of 4mL placebo gel~Placebo: KY Jelly"
208260|NCT01534416|B3|Baseline|Total|Total of all reporting groups
208261|NCT01534416|B2|Baseline|Saline|Subjects injected paracervically with 10 ml of normal saline prior to surgical incision.
208262|NCT01534416|B1|Baseline|Bupivacaine|Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision.
208269|NCT01534416|O2|Outcome|Saline Group|Subjects injected paracervically with 10 ml of normal saline prior to surgical incision who were admitted for pain management
208270|NCT01534416|O1|Outcome|Bupivacaine|Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision and admitted for pain management
208271|NCT01534416|O4|Outcome|Saline Discharged Participants|Subjects who received saline and discharged after surgery. Participants in the Saline arm who were discharged after procedure and not admitted.
208272|NCT01534416|O3|Outcome|Saline Group|Subjects injected paracervically with 10 ml of normal saline prior to surgical incision who were admitted for pain management. participants in the Saline arm who requested admission specifically for pain management.
208273|NCT01534416|O2|Outcome|Bupivacaine Discharged|Subjects who received bupivacaine and epinephrine and discharged home after surgery. Participants in the Bupivacaine arm who were not admitted.
208274|NCT01534416|O1|Outcome|Bupivacaine|"Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision and admitted for pain management.~Participants who requested admission specifically for pain management."
208275|NCT01534416|O2|Outcome|Saline|Subjects injected paracervically with 10 ml of normal saline prior to surgical incision.
208276|NCT01534416|O1|Outcome|Bupivacaine|Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision.
208277|NCT01534416|E2|Reported Event|Saline|Subjects injected paracervically with 10 ml of normal saline prior to surgical incision.
208278|NCT01534416|E1|Reported Event|Bupivacaine|Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision.
208279|NCT01534351|B4|Baseline|Total|Total of all reporting groups
208280|NCT01534351|B3|Baseline|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
208281|NCT01534351|B2|Baseline|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
208282|NCT01534351|B1|Baseline|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
208283|NCT01534351|P3|Participant Flow|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
208284|NCT01534351|P2|Participant Flow|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
208285|NCT01534351|P1|Participant Flow|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
208286|NCT01534351|O3|Outcome|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
208287|NCT01534351|O2|Outcome|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
208288|NCT01534351|O1|Outcome|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
208289|NCT01534351|O3|Outcome|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
208290|NCT01534351|O2|Outcome|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
208291|NCT01534351|O1|Outcome|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
208292|NCT01534351|O3|Outcome|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
208293|NCT01534351|O2|Outcome|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
208294|NCT01534351|O1|Outcome|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
208295|NCT01534351|O3|Outcome|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
208296|NCT01534351|O2|Outcome|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
208297|NCT01534351|O1|Outcome|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
208298|NCT01534351|E3|Reported Event|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
208299|NCT01534351|E2|Reported Event|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
208300|NCT01534351|E1|Reported Event|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
208301|NCT01534208|B3|Baseline|Total|Total of all reporting groups
208302|NCT01534208|B2|Baseline|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
208303|NCT01534208|B1|Baseline|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
208304|NCT01534208|P2|Participant Flow|Androxal 25 mg|"Androxal 25 mg daily~Androxal, oral, 25 mg capsule, taken once daily"
208305|NCT01534208|P1|Participant Flow|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal, oral, 12.5 mg capsule, taken once daily"
208306|NCT01534208|O2|Outcome|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
208307|NCT01534208|O1|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
208308|NCT01534208|O2|Outcome|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
208309|NCT01534208|O1|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
208310|NCT01534208|O2|Outcome|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
208311|NCT01534208|O1|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
208312|NCT01534208|O2|Outcome|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
208313|NCT01534208|O1|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
208314|NCT01534208|O2|Outcome|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
208315|NCT01534208|O1|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
208316|NCT01534208|O2|Outcome|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
208317|NCT01534208|O1|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
208318|NCT01534208|E2|Reported Event|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
208319|NCT01534208|E1|Reported Event|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
208320|NCT01534182|B3|Baseline|Total|Total of all reporting groups
208321|NCT01534182|B2|Baseline|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
208322|NCT01534182|B1|Baseline|Fingolimod|Participants received 0.5 mg orally once a day.
208323|NCT01534182|P2|Participant Flow|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
208324|NCT01534182|P1|Participant Flow|Fingolimod|Participants received 0.5 mg orally once a day.
208325|NCT01534182|O2|Outcome|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
208326|NCT01534182|O1|Outcome|Fingolimod|Participants received 0.5 mg orally once a day.
208327|NCT01534182|O2|Outcome|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
208328|NCT01534182|O1|Outcome|Fingolimod|Participants received 0.5 mg orally once a day.
208329|NCT01534182|O2|Outcome|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
208330|NCT01534182|O1|Outcome|Fingolimod|Participants received 0.5 mg orally once a day.
208331|NCT01534182|O2|Outcome|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
208332|NCT01534182|O1|Outcome|Fingolimod|Participants received 0.5 mg orally once a day.
208333|NCT01534182|O2|Outcome|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
208334|NCT01534182|O1|Outcome|Fingolimod|Participants received 0.5 mg orally once a day.
210094|NCT01526733|B1|Baseline|All Enrolled Participants|All participants enrolled in the study.
208335|NCT01534182|E3|Reported Event|Standard Disease Modifying Therapy: Glatiramer Acetate|Patients who received glatiramer acetate (GA), 20 mg subcutaneously once a day.
208336|NCT01534182|E2|Reported Event|Standard Disease Modifying Therapy (DMT): Interferon Beta-1a|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week
208337|NCT01534182|E1|Reported Event|Fingolimod|Participants received 0.5 mg orally once a day.
208338|NCT01534143|B1|Baseline|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
208339|NCT01534143|P1|Participant Flow|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
208340|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
208341|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
208342|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
208343|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
208344|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
208345|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
208346|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
208347|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
208508|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
208348|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
208349|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
208350|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
208351|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
208352|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
208353|NCT01534143|E1|Reported Event|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
208354|NCT01534078|B1|Baseline|Treatment Arm|"Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine~Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg~Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine"
208355|NCT01534078|P1|Participant Flow|Treatment Arm|"Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine (AVD)~Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg~Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine"
208356|NCT01534078|O1|Outcome|Treatment Arm|"Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine~Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg~Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine"
208357|NCT01534078|O1|Outcome|Treatment Arm|"Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine~Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg~Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine"
208358|NCT01534078|O1|Outcome|Treatment Arm|"Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine~Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg~Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine"
208359|NCT01534078|O1|Outcome|Treatment Arm|"Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine~Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg~Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine"
208360|NCT01534078|E1|Reported Event|Treatment Arm|"Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine~Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg~Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine"
208361|NCT01534052|B1|Baseline|Enzalutamide|Participants received 160 mg enzalutamide orally once a day. Participants continued on treatment unless the dose was reduced or treatment was interrupted during the study.
208362|NCT01534052|P1|Participant Flow|Enzalutamide|Participants received 160 mg enzalutamide orally once a day. Participants continued on treatment unless the dose was reduced or treatment was interrupted during the study.
208363|NCT01534052|O1|Outcome|Enzalutamide|Participants received 160 mg enzalutamide orally once a day. Participants continued on treatment unless the dose was reduced or treatment was interrupted during the study.
208364|NCT01534052|E1|Reported Event|Enzalutimide|Participants received 160 mg enzalutamide orally once a day. Participants continued on treatment unless the dose was reduced or treatment was interrupted during the study.
208365|NCT01533974|B3|Baseline|Total|Total of all reporting groups
208366|NCT01533974|B2|Baseline|Cognitive Behavioral Therapy (CBT)|Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH.
208367|NCT01533974|B1|Baseline|Acceptance and Commitment Therapy (ACT)|"We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker’s ACT treatment program.~Acceptance & Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program."
208368|NCT01533974|P2|Participant Flow|Cognitive Behavioral Therapy (CBT)|Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH.
208369|NCT01533974|P1|Participant Flow|Acceptance and Commitment Therapy (ACT)|"We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker’s ACT treatment program.~Acceptance & Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program."
208370|NCT01533974|O2|Outcome|Cognitive Behavioral Therapy (CBT)|Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH.
208371|NCT01533974|O1|Outcome|Acceptance and Commitment Therapy (ACT)|"We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker’s ACT treatment program.~Acceptance & Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program."
208372|NCT01533974|E2|Reported Event|Cognitive Behavioral Therapy (CBT)|Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH.
208373|NCT01533974|E1|Reported Event|Acceptance and Commitment Therapy (ACT)|"We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker’s ACT treatment program.~Acceptance & Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program."
208374|NCT01533948|B1|Baseline|Treatment (Axitinib)|"Patients receive axitinib PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~axitinib: Given PO~The starting dose for axitinib is 5 mg taken orally twice daily with food. Axitinib will be taken beginning on Day 1 of the study and taken approximately 12 hours apart continuous dosing.~Dose Level Dose Dispensed As~2: 10 mg PO BID 2 X 5 mg tablets BID~1: 7 mg PO BID 1 X 5 mg tablet BID + 2 X 1 mg tablets BID 0: (Starting Dose) 5 mg PO BID 1 X 5 mg tablet BID~1: 3 mg PO BID 3 X 1 mg tablets BID~2: 2 mg PO BID 2 X 1 mg tablets BID"
208375|NCT01533948|P1|Participant Flow|Treatment (Axitinib)|"Patients receive axitinib PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~axitinib: Given PO~The starting dose for axitinib is 5 mg taken orally twice daily with food. Axitinib will be taken beginning on Day 1 of the study and taken approximately 12 hours apart continuous dosing.~Dose Level Dose Dispensed As~2: 10 mg PO BID 2 X 5 mg tablets BID~1: 7 mg PO BID 1 X 5 mg tablet BID + 2 X 1 mg tablets BID 0: (Starting Dose) 5 mg PO BID 1 X 5 mg tablet BID~1: 3 mg PO BID 3 X 1 mg tablets BID~2: 2 mg PO BID 2 X 1 mg tablets BID"
208376|NCT01533948|O1|Outcome|Treatment (Axitinib)|"Patients receive axitinib PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~axitinib: Given PO~The starting dose for axitinib is 5 mg taken orally twice daily with food. Axitinib will be taken beginning on Day 1 of the study and taken approximately 12 hours apart continuous dosing.~Dose Level Dose Dispensed As~2: 10 mg PO BID 2 X 5 mg tablets BID~1: 7 mg PO BID 1 X 5 mg tablet BID + 2 X 1 mg tablets BID 0: (Starting Dose) 5 mg PO BID 1 X 5 mg tablet BID~1: 3 mg PO BID 3 X 1 mg tablets BID~2: 2 mg PO BID 2 X 1 mg tablets BID"
208377|NCT01533948|O1|Outcome|Treatment (Axitinib)|"Patients receive axitinib PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~axitinib: Given PO~The starting dose for axitinib is 5 mg taken orally twice daily with food. Axitinib will be taken beginning on Day 1 of the study and taken approximately 12 hours apart continuous dosing.~Dose Level Dose Dispensed As~2: 10 mg PO BID 2 X 5 mg tablets BID~1: 7 mg PO BID 1 X 5 mg tablet BID + 2 X 1 mg tablets BID 0: (Starting Dose) 5 mg PO BID 1 X 5 mg tablet BID~1: 3 mg PO BID 3 X 1 mg tablets BID~2: 2 mg PO BID 2 X 1 mg tablets BID"
208378|NCT01533948|O1|Outcome|Treatment (Axitinib)|"Patients receive axitinib PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~axitinib: Given PO~The starting dose for axitinib is 5 mg taken orally twice daily with food. Axitinib will be taken beginning on Day 1 of the study and taken approximately 12 hours apart continuous dosing.~Dose Level Dose Dispensed As~2: 10 mg PO BID 2 X 5 mg tablets BID~1: 7 mg PO BID 1 X 5 mg tablet BID + 2 X 1 mg tablets BID 0: (Starting Dose) 5 mg PO BID 1 X 5 mg tablet BID~1: 3 mg PO BID 3 X 1 mg tablets BID~2: 2 mg PO BID 2 X 1 mg tablets BID"
208379|NCT01533948|O1|Outcome|Treatment (Axitinib)|"Patients receive axitinib PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~axitinib: Given PO~The starting dose for axitinib is 5 mg taken orally twice daily with food. Axitinib will be taken beginning on Day 1 of the study and taken approximately 12 hours apart continuous dosing.~Dose Level Dose Dispensed As~2: 10 mg PO BID 2 X 5 mg tablets BID~1: 7 mg PO BID 1 X 5 mg tablet BID + 2 X 1 mg tablets BID 0: (Starting Dose) 5 mg PO BID 1 X 5 mg tablet BID~1: 3 mg PO BID 3 X 1 mg tablets BID~2: 2 mg PO BID 2 X 1 mg tablets BID"
208380|NCT01533948|O1|Outcome|Treatment (Axitinib)|"Patients receive axitinib PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~axitinib: Given PO~The starting dose for axitinib is 5 mg taken orally twice daily with food. Axitinib will be taken beginning on Day 1 of the study and taken approximately 12 hours apart continuous dosing.~Dose Level Dose Dispensed As~2: 10 mg PO BID 2 X 5 mg tablets BID~1: 7 mg PO BID 1 X 5 mg tablet BID + 2 X 1 mg tablets BID 0: (Starting Dose) 5 mg PO BID 1 X 5 mg tablet BID~1: 3 mg PO BID 3 X 1 mg tablets BID~2: 2 mg PO BID 2 X 1 mg tablets BID"
208381|NCT01533948|E1|Reported Event|Treatment (Axitinib)|"Patients receive axitinib PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~axitinib: Given PO~laboratory biomarker analysis: Correlative studies"
208509|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
208382|NCT01533935|B1|Baseline|Overall Study|"A randomised, double-blind, placebo controlled, 5 treatment, 4-period, incomplete, crossover study. Each treatment period was separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were:~Oral inhalation of placebo~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Treatment sequence is not considered as a factor which may affect the treatment effect due to sufficient washout period added between treatment cycles. As a result, we only display baseline characteristics as a whole population, but not by treatment sequence"
208383|NCT01533935|P5|Participant Flow|Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were~Oral inhalation of placebo~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Tiotropium fixed dose 5 µg"
208384|NCT01533935|P4|Participant Flow|Olo / Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were~Olodaterol fixed dose 5 µg~Oral inhalation of placebo~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg"
208385|NCT01533935|P3|Participant Flow|Tio / Olo / Placebo / Tio+Olo 2.5/5|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg~Oral inhalation of placebo~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg"
208386|NCT01533935|P2|Participant Flow|Tio+Olo 5/5 / Tio / Olo / Placebo|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg~Oral inhalation of placebo"
208387|NCT01533935|P1|Participant Flow|Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio / Olo|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg.~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg"
208388|NCT01533935|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208389|NCT01533935|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208390|NCT01533935|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208391|NCT01533935|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208392|NCT01533935|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
208393|NCT01533935|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208394|NCT01533935|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208395|NCT01533935|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208396|NCT01533935|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208397|NCT01533935|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
208398|NCT01533935|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208399|NCT01533935|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208400|NCT01533935|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208401|NCT01533935|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208402|NCT01533935|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
208403|NCT01533935|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208404|NCT01533935|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208405|NCT01533935|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208510|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
208406|NCT01533935|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208407|NCT01533935|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
208408|NCT01533935|E5|Reported Event|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208409|NCT01533935|E4|Reported Event|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208410|NCT01533935|E3|Reported Event|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208411|NCT01533935|E2|Reported Event|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208412|NCT01533935|E1|Reported Event|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
208413|NCT01533922|B1|Baseline|Overall Study|"A randomised, double-blind, placebo controlled, 5 treatment, 4-period, incomplete, crossover study. Each treatment period was separated by a washout period of 21 days. The 5 treatments, administered orally via the respimat inhaler, once daily, in the morning were:~Oral inhalation of placebo~Olodaterol fixed dose 5 µg~Tiotropium fixed dose 5 µg~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Treatment sequence is not considered as a factor which may affect the treatment effect due to sufficient washout period added between treatment cycles. As a result, we only display baseline characteristics as a whole population, but not by treatment sequence"
208414|NCT01533922|P5|Participant Flow|Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:~Oral inhalation of placebo~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Tiotropium fixed dose 5 µg"
208415|NCT01533922|P4|Participant Flow|Olo / Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:~Olodaterol fixed dose 5 µg~Oral inhalation of placebo~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg"
208416|NCT01533922|P3|Participant Flow|Tio / Olo / Placebo / Tio+Olo 2.5/5|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg~Oral inhalation of placebo~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg"
208417|NCT01533922|P2|Participant Flow|Tio+Olo 5/5 / Tio / Olo / Placebo|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg~Oral inhalation of placebo"
208418|NCT01533922|P1|Participant Flow|Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio / Olo|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg"
208419|NCT01533922|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208420|NCT01533922|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208421|NCT01533922|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208422|NCT01533922|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208423|NCT01533922|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
208424|NCT01533922|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208425|NCT01533922|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208426|NCT01533922|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208427|NCT01533922|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208428|NCT01533922|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
208429|NCT01533922|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208430|NCT01533922|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208431|NCT01533922|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208432|NCT01533922|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208433|NCT01533922|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
208434|NCT01533922|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208435|NCT01533922|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208436|NCT01533922|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208437|NCT01533922|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208438|NCT01533922|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
208439|NCT01533922|E5|Reported Event|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208440|NCT01533922|E4|Reported Event|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208441|NCT01533922|E3|Reported Event|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208442|NCT01533922|E2|Reported Event|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
208443|NCT01533922|E1|Reported Event|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
208444|NCT01533753|B3|Baseline|Total|Total of all reporting groups
208445|NCT01533753|B2|Baseline|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.~Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
208446|NCT01533753|B1|Baseline|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.~Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
208447|NCT01533753|P2|Participant Flow|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.~Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
208448|NCT01533753|P1|Participant Flow|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.~Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
208449|NCT01533753|O2|Outcome|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.~Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
208450|NCT01533753|O1|Outcome|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.~Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
208451|NCT01533753|O2|Outcome|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.~Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
208452|NCT01533753|O1|Outcome|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.~Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
208511|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
208512|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
208453|NCT01533753|O2|Outcome|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.~Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
208454|NCT01533753|O1|Outcome|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.~Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
208455|NCT01533753|O2|Outcome|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.~Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
208456|NCT01533753|O1|Outcome|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.~Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
208457|NCT01533753|E2|Reported Event|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.~Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
208458|NCT01533753|E1|Reported Event|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.~Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
208459|NCT01533597|B3|Baseline|Total|Total of all reporting groups
208460|NCT01533597|B2|Baseline|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
208461|NCT01533597|B1|Baseline|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
208462|NCT01533597|P2|Participant Flow|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
208463|NCT01533597|P1|Participant Flow|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
208464|NCT01533597|O2|Outcome|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
208465|NCT01533597|O1|Outcome|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
208466|NCT01533597|O2|Outcome|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
208467|NCT01533597|O1|Outcome|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
208468|NCT01533597|O2|Outcome|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
208469|NCT01533597|O1|Outcome|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
208470|NCT01533597|O2|Outcome|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
208471|NCT01533597|O1|Outcome|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
208472|NCT01533597|O2|Outcome|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
208473|NCT01533597|O1|Outcome|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
208474|NCT01533597|O2|Outcome|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
208475|NCT01533597|O1|Outcome|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
208476|NCT01533597|E2|Reported Event|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
208477|NCT01533597|E1|Reported Event|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
208478|NCT01533493|B3|Baseline|Total|Total of all reporting groups
208479|NCT01533493|B2|Baseline|Placebo|"Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate~Placebo : Memantine-matched placebo will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
208480|NCT01533493|B1|Baseline|Memantine|"Subjects randomized to receive Memantine in addition to open-label OROS-Methylphenidate~Memantine Hydrochloride : Memantine will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
208481|NCT01533493|P2|Participant Flow|Placebo|"Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate~Placebo : Memantine-matched placebo will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
208482|NCT01533493|P1|Participant Flow|Memantine|"Subjects randomized to receive Memantine in addition to open-label OROS-Methylphenidate~Memantine Hydrochloride : Memantine will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
208483|NCT01533493|O2|Outcome|Placebo|"Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate~Placebo : Memantine-matched placebo will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
208484|NCT01533493|O1|Outcome|Memantine|"Subjects randomized to receive Memantine in addition to open-label OROS-Methylphenidate~Memantine Hydrochloride : Memantine will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
208485|NCT01533493|E2|Reported Event|Placebo|"Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate~Placebo : Memantine-matched placebo will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
208486|NCT01533493|E1|Reported Event|Memantine|"Subjects randomized to receive Memantine in addition to open-label OROS-Methylphenidate~Memantine Hydrochloride : Memantine will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
208487|NCT01533428|B3|Baseline|Total|Total of all reporting groups
208488|NCT01533428|B2|Baseline|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
208489|NCT01533428|B1|Baseline|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
208490|NCT01533428|P2|Participant Flow|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
208491|NCT01533428|P1|Participant Flow|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
208492|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
208493|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
208494|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
208495|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
208496|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
208497|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
208498|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
208499|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
208500|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
208501|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
208502|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
208503|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
208504|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
208505|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
208506|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
208507|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
208513|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
208514|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
208515|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
208516|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
208517|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
208518|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
208519|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
208520|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
208521|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
208522|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
208523|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
208524|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
208525|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
208526|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
208527|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
208528|NCT01533428|E2|Reported Event|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
208529|NCT01533428|E1|Reported Event|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
208530|NCT01533259|B1|Baseline|Stribild|Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
208531|NCT01533259|P1|Participant Flow|Stribild|Switch from existing treatment regimen to Stribild® (elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg) single-tablet regiment (STR) once daily for 48 weeks
208532|NCT01533259|O1|Outcome|Stribild|Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
208533|NCT01533259|O1|Outcome|Stribild|Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
208534|NCT01533259|O1|Outcome|Stribild|Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
208535|NCT01533259|E1|Reported Event|Stribild|Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
208536|NCT01533246|B1|Baseline|Treatment (Linsitinib)|"Patients receive linsitinib 150mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
208537|NCT01533246|P1|Participant Flow|Treatment (Linsitinib)|"Patients receive linsitinib 150mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
208538|NCT01533246|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
208539|NCT01533246|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
208540|NCT01533246|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
208541|NCT01533246|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
208542|NCT01533246|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
208543|NCT01533246|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
208544|NCT01533246|E1|Reported Event|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
208545|NCT01533181|B3|Baseline|Total|Total of all reporting groups
208547|NCT01533181|B1|Baseline|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
208548|NCT01533181|P2|Participant Flow|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
208549|NCT01533181|P1|Participant Flow|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
208550|NCT01533181|O2|Outcome|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
208551|NCT01533181|O1|Outcome|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
208552|NCT01533181|O2|Outcome|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
208553|NCT01533181|O1|Outcome|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
208554|NCT01533181|O2|Outcome|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
208555|NCT01533181|O1|Outcome|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
208556|NCT01533181|O2|Outcome|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
208557|NCT01533181|O1|Outcome|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
208558|NCT01533181|E2|Reported Event|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
208559|NCT01533181|E1|Reported Event|Arm A: Topotocan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
208560|NCT01533116|B5|Baseline|Total|Total of all reporting groups
208561|NCT01533116|B4|Baseline|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
208562|NCT01533116|B3|Baseline|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
208563|NCT01533116|B2|Baseline|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
208564|NCT01533116|B1|Baseline|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
208565|NCT01533116|P4|Participant Flow|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
208566|NCT01533116|P3|Participant Flow|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
208567|NCT01533116|P2|Participant Flow|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
208568|NCT01533116|P1|Participant Flow|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
208569|NCT01533116|O4|Outcome|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
208570|NCT01533116|O3|Outcome|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
208571|NCT01533116|O2|Outcome|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
208572|NCT01533116|O1|Outcome|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
208573|NCT01533116|O4|Outcome|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
208574|NCT01533116|O3|Outcome|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
208575|NCT01533116|O2|Outcome|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
208576|NCT01533116|O1|Outcome|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
208577|NCT01533116|O4|Outcome|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
208578|NCT01533116|O3|Outcome|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
208579|NCT01533116|O2|Outcome|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
208611|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208580|NCT01533116|O1|Outcome|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
208581|NCT01533116|O4|Outcome|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
208582|NCT01533116|O3|Outcome|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
208583|NCT01533116|O2|Outcome|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
208584|NCT01533116|O1|Outcome|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
208585|NCT01533116|O4|Outcome|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
208586|NCT01533116|O3|Outcome|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
208587|NCT01533116|O2|Outcome|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
208588|NCT01533116|O1|Outcome|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
208589|NCT01533116|E4|Reported Event|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
208590|NCT01533116|E3|Reported Event|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
208591|NCT01533116|E2|Reported Event|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
208592|NCT01533116|E1|Reported Event|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
208593|NCT01533077|B5|Baseline|Total|Total of all reporting groups
208594|NCT01533077|B4|Baseline|Group 4|"Period 1: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 2: BIA 9-1067 50 mg + Sinemet® 100/25 Period 3: Sinemet® 100/25 Period 4: BIA 9-1067 50 mg~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
208595|NCT01533077|B3|Baseline|Group 3|"Period 1: BIA 9-1067 50 mg + Sinemet® 100/25 Period 2: Sinemet® 100/25 Period 3: BIA 9-1067 50 mg Period 4: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
208596|NCT01533077|B2|Baseline|Group 2|"Period 1: Sinemet® 100/25 Period 2: BIA 9-1067 50 mg Period 3: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 4: BIA 9-1067 50 mg + Sinemet® 100/25~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
208597|NCT01533077|B1|Baseline|Group 1|"Period 1: BIA 9-1067 50 mg Period 2: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 3: BIA 9-1067 50 mg + Sinemet® 100/25 Period 4: Sinemet® 100/25~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
208598|NCT01533077|P4|Participant Flow|Group 4|"Period 1: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 2: BIA 9-1067 50 mg + Sinemet® 100/25 Period 3: Sinemet® 100/25 Period 4: BIA 9-1067 50 mg~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
208599|NCT01533077|P3|Participant Flow|Group 3|"Period 1: BIA 9-1067 50 mg + Sinemet® 100/25 Period 2: Sinemet® 100/25 Period 3: BIA 9-1067 50 mg Period 4: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
208600|NCT01533077|P2|Participant Flow|Group 2|"Period 1: Sinemet® 100/25 Period 2: BIA 9-1067 50 mg Period 3: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 4: BIA 9-1067 50 mg + Sinemet® 100/25~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
208601|NCT01533077|P1|Participant Flow|Group 1|"Period 1: BIA 9-1067 50 mg Period 2: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 3: BIA 9-1067 50 mg + Sinemet® 100/25 Period 4: Sinemet® 100/25~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
208602|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208603|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208604|NCT01533077|O1|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg
208605|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208606|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208607|NCT01533077|O1|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg
208608|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208609|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208610|NCT01533077|O1|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg
210241|NCT01525667|O2|Outcome|PLX-PAD High Dose|PLX-PAD high dose: Single treatment, multiple injections
208612|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208613|NCT01533077|O1|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg
208614|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208615|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208616|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
208617|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208618|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208619|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
208620|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208621|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208622|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
208623|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208624|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208625|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
208626|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208627|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208628|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
208629|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208630|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208631|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
208632|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208633|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208634|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
208635|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208636|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208637|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
208638|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208639|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208640|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
208641|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208642|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208643|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
208644|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208645|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208646|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
208647|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208648|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
208649|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
208650|NCT01533077|E4|Reported Event|Sinemet® 100/25 mg|Sinemet® 100/25 mg.
208651|NCT01533077|E3|Reported Event|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly.
208652|NCT01533077|E2|Reported Event|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h.
208653|NCT01533077|E1|Reported Event|BIA 9-1067 50 mg|BIA 9-1067 50 mg.
208654|NCT01533038|B3|Baseline|Total|Total of all reporting groups
208655|NCT01533038|B2|Baseline|Transurethral Resection of the Prostate|"Transurethral Resection of the Prostate surgery~Transurethral Resection of the Prostate: Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck."
208698|NCT01532973|P10|Participant Flow|GT1a HCV 50-mg Elbasvir (Panel J)|Participants with GT1a only HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
208747|NCT01532934|B2|Baseline|Standard Care (SC)|Standard Care: Individuals received assessment only, plus the usual range of services provided by Monroe County Pretrial
208656|NCT01533038|B1|Baseline|UroLift System|"UroLift System procedure~UroLift System: The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra."
208657|NCT01533038|P2|Participant Flow|Transurethral Resection of the Prostate|"Transurethral Resection of the Prostate surgery~Transurethral Resection of the Prostate: Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck."
208658|NCT01533038|P1|Participant Flow|UroLift System|"UroLift System procedure~UroLift System: The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra."
208659|NCT01533038|O2|Outcome|Transurethral Resection of the Prostate|"Transurethral Resection of the Prostate surgery~Transurethral Resection of the Prostate: Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck."
208660|NCT01533038|O1|Outcome|UroLift System|"UroLift System procedure~UroLift System: The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra."
208661|NCT01533038|E2|Reported Event|Transurethral Resection of the Prostate|"Transurethral Resection of the Prostate surgery~Transurethral Resection of the Prostate: Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck."
208662|NCT01533038|E1|Reported Event|UroLift System|"UroLift System procedure~UroLift System: The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra."
208663|NCT01532999|B3|Baseline|Total|Total of all reporting groups
208664|NCT01532999|B2|Baseline|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
208665|NCT01532999|B1|Baseline|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
208666|NCT01532999|P2|Participant Flow|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
208667|NCT01532999|P1|Participant Flow|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
208699|NCT01532973|P9|Participant Flow|GT1a HCV 10-mg Elbasvir (Panel I)|Participants with GT1a only HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
208668|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
208669|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
208670|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
208671|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
208672|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
208673|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
208674|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
208675|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
208676|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
208677|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
208678|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
208700|NCT01532973|P8|Participant Flow|GT3 HCV 200-mg Elbasvir (Panel H)|Participants with GT3 HCV receive 200-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
208701|NCT01532973|P7|Participant Flow|GT3 HCV 100-mg Elbasvir (Panel G)|Participants with GT3 HCV receive 100-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
208679|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
208680|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
208681|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
208682|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
208683|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
208684|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
208685|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
208686|NCT01532999|E2|Reported Event|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
208687|NCT01532999|E1|Reported Event|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
208688|NCT01532973|B10|Baseline|Total|Total of all reporting groups
208689|NCT01532973|B9|Baseline|Placebo|Participants with GT1, GT3 or GT1a HCV who received placebo in Parts I, II, or II of the study.
208690|NCT01532973|B8|Baseline|GT1a HCV 50-mg Elbasvir (Panel J)|Participants with GT1a only HCV receive 50-mg elbasvir for 5 consecutive days during Part III of the study.
208691|NCT01532973|B7|Baseline|GT1a HCV 10-mg Elbasvir (Panel I)|Participants with GT1a only HCV receive 10-mg elbasvir for 5 consecutive days during Part III of the study.
208692|NCT01532973|B6|Baseline|GT3 HCV 100-mg Elbasvir (Panel G)|Participants with GT3 HCV receive 100-mg elbasvir for 5 consecutive days during Part II of the study.
208693|NCT01532973|B5|Baseline|GT3 HCV 50-mg Elbasvir (Panel F)|Participants with GT3 HCV receive 50-mg elbasvir for 5 consecutive days during Part II of the study.
208694|NCT01532973|B4|Baseline|GT3 HCV 10-mg Elbasvir (Panel E)|Participants with GT3 HCV receive 10-mg elbasvir for 5 consecutive days during Part II of the study.
208695|NCT01532973|B3|Baseline|GT1 HCV 5-mg Elbasvir (Panel C)|Participants with GT1 HCV receive 5-mg elbasvir for 5 consecutive days during Part I of the study.
208696|NCT01532973|B2|Baseline|GT1 HCV 50-g Elbasvir (Panel B)|Participants with GT1 HCV receive 50-mg elbasvir for 5 consecutive days during Part I of the study.
208697|NCT01532973|B1|Baseline|GT1 HCV 10-mg Elbasvir (Panel A)|Participants with GT1 Hepatitis who received 10 -mg elbasvir for 5 consecutive days during Part I of the study.
208702|NCT01532973|P6|Participant Flow|GT3 HCV 50-mg Elbasvir (Panel F)|Participants with GT3 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
208703|NCT01532973|P5|Participant Flow|GT3 HCV 10-mg Elbasvir (Panel E)|Participants with GT3 HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
208704|NCT01532973|P4|Participant Flow|GT1 HCV 200-mg Elbasvir (Panel D)|Participants with GT1 HCV receive 200-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
208705|NCT01532973|P3|Participant Flow|GT1 HCV 5-mg Elbasvir (Panel C)|Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
208706|NCT01532973|P2|Participant Flow|GT1 HCV 50-g Elbasvir (Panel B)|Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
208707|NCT01532973|P1|Participant Flow|GT1 HCV 10-mg Elbasvir (Panel A)|Participants with genotype (GT) 1 hepatitis C virus (HCV) receive 10 -mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
208708|NCT01532973|O5|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
208709|NCT01532973|O4|Outcome|100-mg Elbasvir|Participants with HCV GT3 who received 100-mg elbasvir
208710|NCT01532973|O3|Outcome|50-mg Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 50-mg elbasvir
208711|NCT01532973|O2|Outcome|10-g Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 10-mg elbasvir
208712|NCT01532973|O1|Outcome|5-mg Elbasvir|Participants with HCV GT1 who received 5 -mg elbasvir
208713|NCT01532973|O5|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during.
208714|NCT01532973|O4|Outcome|100-mg Elbasvir|Participants with HCV GT3 who received 100-mg elbasvir
208715|NCT01532973|O3|Outcome|50-mg Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 50-mg elbasvir
208716|NCT01532973|O2|Outcome|10-g Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 10-mg elbasvir
208717|NCT01532973|O1|Outcome|5-mg Elbasvir|Participants with HCV GT1 who received 5 -mg elbasvir
208718|NCT01532973|O3|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
208719|NCT01532973|O2|Outcome|GT1a HCV 50-mg Elbasvir (Panel J)|Participants with GT1a only HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
208720|NCT01532973|O1|Outcome|GT1a HCV 10-mg Elbasvir (Panel I)|Participants with GT1a only HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
208721|NCT01532973|O4|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
208722|NCT01532973|O3|Outcome|GT3 HCV 100-mg Elbasvir (Panel G)|Participants with GT3 HCV receive 100-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
208723|NCT01532973|O2|Outcome|GT3 HCV 50-mg Elbasvir (Panel F)|Participants with GT3 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
208724|NCT01532973|O1|Outcome|GT3 HCV 10-mg Elbasvir (Panel E)|Participants with GT3 HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
208725|NCT01532973|O4|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
208726|NCT01532973|O3|Outcome|GT1 HCV 5-mg Elbasvir (Panel C)|Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
208727|NCT01532973|O2|Outcome|GT1 HCV 50-g Elbasvir (Panel B)|Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
208728|NCT01532973|O1|Outcome|GT1 HCV 10-mg Elbasvir (Panel A)|Participants with GT1 Hepatitis receive 10 -mg elbasvir for 5 consecutive days during Part I of the study.
208729|NCT01532973|O3|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
208730|NCT01532973|O2|Outcome|GT1a HCV 50-mg Elbasvir (Panel J)|Participants with GT1a only HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
208731|NCT01532973|O1|Outcome|GT1a HCV 10-mg Elbasvir (Panel I)|Participants with GT1a only HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
208732|NCT01532973|O4|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
208733|NCT01532973|O3|Outcome|GT3 HCV 100-mg Elbasvir (Panel G)|Participants with GT3 HCV receive 100-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
208734|NCT01532973|O2|Outcome|GT3 HCV 50-mg Elbasvir (Panel F)|Participants with GT3 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
208735|NCT01532973|O1|Outcome|GT3 HCV 10-mg Elbasvir (Panel E)|Participants with GT3 HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
208736|NCT01532973|O4|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
208737|NCT01532973|O3|Outcome|GT1 HCV 5-mg Elbasvir (Panel C)|Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
208738|NCT01532973|O2|Outcome|GT1 HCV 50-g Elbasvir (Panel B)|Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
208739|NCT01532973|O1|Outcome|GT1 HCV 10-mg Elbasvir (Panel A)|Participants with GT1 Hepatitis receive 10 -mg elbasvir for 5 consecutive days during Part I of the study.
208740|NCT01532973|E6|Reported Event|Post-Study|All participants who received 5, 10, 50, or 100 mg of elbasvir or placebo in treatment period of study
208741|NCT01532973|E5|Reported Event|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during.
208742|NCT01532973|E4|Reported Event|100-mg Elbasvir|Participants with HCV GT3 who received 100-mg elbasvir
208743|NCT01532973|E3|Reported Event|50-mg Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 50-mg elbasvir
208744|NCT01532973|E2|Reported Event|10-g Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 10-mg elbasvir
208745|NCT01532973|E1|Reported Event|5-mg Elbasvir|Participants with HCV GT1 who received 5 -mg elbasvir
208746|NCT01532934|B3|Baseline|Total|Total of all reporting groups
208748|NCT01532934|B1|Baseline|Brief Motivational Intervention Plus Standard Care (BMI+SC)|Brief Motivational Intervention plus Standard Care; Individuals received up to 4 intervention sessions plus assessment and the usual range of services provided by Monroe County Pretrial
208749|NCT01532934|P2|Participant Flow|Standard Care|"standard care~standard care: standard care"
208750|NCT01532934|P1|Participant Flow|Brief Therapy|"motivational enhancement therapy for substance use~motivational enhancement therapy: Four 45-minute MET sessions"
208751|NCT01532934|O2|Outcome|Standard Care|Assessment only plus the usual range of pretrial services
208752|NCT01532934|O1|Outcome|BMI+SC|"brief MI + standard care~standard care"
208753|NCT01532934|O2|Outcome|Standard Care|"standard care~standard care: standard care"
208754|NCT01532934|O1|Outcome|Brief Therapy|"motivational enhancement therapy for substance use~motivational enhancement therapy: Four 45-minute MET sessions"
208755|NCT01532934|O2|Outcome|Standard Care|Assessment only plus the usual range of pretrial services
208756|NCT01532934|O1|Outcome|BMI+SC|"brief MI + standard care~standard care"
208757|NCT01532934|E2|Reported Event|Standard Care|There were no adverse events for members of this group.
208758|NCT01532934|E1|Reported Event|Brief Motivational Intervention Plus Standard Care|There were no adverse events for members of this group.
208759|NCT01532869|B3|Baseline|Total|Total of all reporting groups
208760|NCT01532869|B2|Baseline|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
208761|NCT01532869|B1|Baseline|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
208762|NCT01532869|P2|Participant Flow|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
208763|NCT01532869|P1|Participant Flow|Placebo|Participants received tocilizumab (TCZ) matched placebo by subcutaneous (SC) injection every week (qw) for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 milligrams [mg]) SC injection qw in the open-label period for Week 48 to Week 96.
208764|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
208765|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
208766|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
208767|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
208768|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
208769|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
208770|NCT01532869|O1|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
208771|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
208772|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
208773|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
208774|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
208775|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
208776|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
208777|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
208778|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
208779|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
208780|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
208781|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
208782|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
208783|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
210242|NCT01525667|O1|Outcome|PLX-PAD Low Dose|PLX-PAD low dose: Single treatment, multiple injections
208784|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
208785|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
208786|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
208787|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
208788|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
208789|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
208790|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
208791|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
208792|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
208793|NCT01532869|E6|Reported Event|Tocilizumab to Tocilizumab (up to 96 Weeks)|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96. The data analyzed for double-blind tocilizumab to open-label tocilizumab up to Week 96 are presented in this reporting group.
208794|NCT01532869|E5|Reported Event|Placebo to Tocilizumab (up to 96 Weeks)|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96. The data analyzed for double-blind placebo to open-label tocilizumab up to Week 96 are presented in this reporting group.
208795|NCT01532869|E4|Reported Event|Tocilizumab (up to 48 Weeks)|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96. The data analyzed for TCZ up to Week 48 are presented in this reporting group.
208796|NCT01532869|E3|Reported Event|Placebo (up to 48 Weeks)|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96. The data analyzed for placebo up to Week 48 are presented in this reporting group.
208797|NCT01532869|E2|Reported Event|Tocilizumab (up to 24 Weeks)|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96. The data analyzed for TCZ up to Week 24 was presented in this reporting group.
208798|NCT01532869|E1|Reported Event|Placebo (up to 24 Weeks)|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96. The data analyzed for placebo up to Week 24 are presented in this reporting group.
208799|NCT01532830|B1|Baseline|Active|n-VNS active therapy
208800|NCT01532830|P1|Participant Flow|gammaCore Device|non-invasive vagus nerve stimulator gammaCore: treatment with gammaCore vagus nerve stimulator
208801|NCT01532830|O1|Outcome|Active|n-VNS active therapy
208802|NCT01532830|O1|Outcome|Active|n-VNS active therapy
208803|NCT01532830|O1|Outcome|Active|n-VNS active therapy
208804|NCT01532830|O1|Outcome|Active|n-VNS active therapy
208805|NCT01532830|O1|Outcome|Active|n-VNS active therapy
208806|NCT01532830|O1|Outcome|Active|n-VNS active therapy
208807|NCT01532830|E1|Reported Event|Active|n-VNS active therapy
208808|NCT01532817|B1|Baseline|Alphacore|"noninvasive neurostimulation of the vagus nerve~AlphaCore: A single 90 second stimulation to the vagus nerve on the right side of the neck"
208809|NCT01532817|P1|Participant Flow|Alphacore|"noninvasive neurostimulation of the vagus nerve~AlphaCore: A single 90 second stimulation to the vagus nerve on the right side of the neck"
208810|NCT01532817|O1|Outcome|Alphacore|"noninvasive neurostimulation of the vagus nerve~AlphaCore: A single 90 second stimulation to the vagus nerve on the right side of the neck"
208811|NCT01532817|E1|Reported Event|Alphacore|"noninvasive neurostimulation of the vagus nerve~AlphaCore: A single 90 second stimulation to the vagus nerve on the right side of the neck"
208812|NCT01532635|B1|Baseline|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
208813|NCT01532635|P1|Participant Flow|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
208814|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
208843|NCT01532570|O1|Outcome|Vascular-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208815|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
208816|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
208817|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
208818|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
208819|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
208820|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
208821|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
208822|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
208823|NCT01532635|E1|Reported Event|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
208824|NCT01532570|B5|Baseline|Total|Total of all reporting groups
208825|NCT01532570|B4|Baseline|Vascular BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208826|NCT01532570|B3|Baseline|Chronic Progressive Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208827|NCT01532570|B2|Baseline|Acute Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208828|NCT01532570|B1|Baseline|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208829|NCT01532570|P4|Participant Flow|Vascular BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208830|NCT01532570|P3|Participant Flow|Chronic Progressive Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208831|NCT01532570|P2|Participant Flow|Acute Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208832|NCT01532570|P1|Participant Flow|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208833|NCT01532570|O1|Outcome|Vascular-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208834|NCT01532570|O3|Outcome|Chronic Progressive Neuro-BD|
208835|NCT01532570|O2|Outcome|Acute Neuro-BD (Patient No.2)|
208836|NCT01532570|O1|Outcome|Acute Neuro BD (Patient No.1)|
208837|NCT01532570|O1|Outcome|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208838|NCT01532570|O3|Outcome|Chronic Progressive Neuro-BD|
208839|NCT01532570|O2|Outcome|Acute Neuro-BD (Patient No.2)|
208840|NCT01532570|O1|Outcome|Acute Neuro BD (Patient No.1)|
208841|NCT01532570|O2|Outcome|Acute Neuro-BD (Patient 2)|
208842|NCT01532570|O1|Outcome|Acute Neuro BD (Patient 1)|
208844|NCT01532570|O1|Outcome|Vascular-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208845|NCT01532570|O1|Outcome|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208846|NCT01532570|O1|Outcome|Vascular-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208847|NCT01532570|O1|Outcome|Chronic Progressive Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208848|NCT01532570|O1|Outcome|Acute Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208849|NCT01532570|O1|Outcome|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208850|NCT01532570|O3|Outcome|Vascular BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208851|NCT01532570|O2|Outcome|Neuro-BD (Acute+Chronic Progressive)|"Acute; A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.~Chronic Progressive; A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30."
208852|NCT01532570|O1|Outcome|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208853|NCT01532570|O4|Outcome|Vascular BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208854|NCT01532570|O3|Outcome|Chronic Progressive Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208855|NCT01532570|O2|Outcome|Acute Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208856|NCT01532570|O1|Outcome|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208857|NCT01532570|O4|Outcome|Vascular BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208858|NCT01532570|O3|Outcome|Chronic Progressive Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208859|NCT01532570|O2|Outcome|Acute Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208860|NCT01532570|O1|Outcome|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208861|NCT01532570|E1|Reported Event|TA-650|TA-650: TA-650 will be intravenously infused at a dosage of 5 mg/kg slowly over a period of more than 2 hours at the first administration (weeks 0), 2, and 6, and then every 8 weeks up to week 46. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
208862|NCT01532453|B3|Baseline|Total|Total of all reporting groups
208863|NCT01532453|B2|Baseline|MD-3511356|MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
208864|NCT01532453|B1|Baseline|Standard Sun Protection Measures|Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
208865|NCT01532453|P2|Participant Flow|MD-3511356|MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
208866|NCT01532453|P1|Participant Flow|Standard Sun Protection Measures|Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
208867|NCT01532453|O2|Outcome|MD-3511356|MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
208868|NCT01532453|O1|Outcome|Standard Sun Protection Measures|Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
208869|NCT01532453|O2|Outcome|MD-3511356|MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
208870|NCT01532453|O1|Outcome|Standard Sun Protection Measures|Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
208899|NCT01532349|P1|Participant Flow|400 IU Vitamin D|Children will be randomly allocated to receive cholecalciferol supplementation 400 IU/day (2,800 IU/weekly), which is the recommended dietary allowance. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
208871|NCT01532453|E2|Reported Event|MD-3511356|"Patients receive detailed information on standardised sun protection measures. Additionally, they will be provided free of charge with MD-3511356 for application to sun exposed skin areas once daily in the morning for 24 months. MD 3511356 lotion will be applied topically on the sun-exposed skin areas (face, neck, head, forearms and hands) in doses corresponding to the surface extent (see chapter 6.1). The dispensers will be provided with a dosage pump to allow application of reproducible amounts (each pump 0,5 g).~MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun."
208872|NCT01532453|E1|Reported Event|Standard Sun Protection Measures|"Detailed information on standardised sun protection measures and application of self-provided sunscreen products. The Investigator may decide on an individual reimbursement of patient's expenditure (out of the centre's budget).~Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product."
208873|NCT01532414|B4|Baseline|Total|Total of all reporting groups
208874|NCT01532414|B3|Baseline|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
208875|NCT01532414|B2|Baseline|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
208876|NCT01532414|B1|Baseline|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months Subjects with morning testosterone <300ng/dL after 6 weeks of treatment were up-titrated to 25 mg/day"
208877|NCT01532414|P3|Participant Flow|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
208878|NCT01532414|P2|Participant Flow|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
208879|NCT01532414|P1|Participant Flow|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months Subjects with morning testosterone <300ng/dL after 6 weeks of treatment were up-titrated to 25 mg/day"
208880|NCT01532414|O2|Outcome|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
208881|NCT01532414|O1|Outcome|Androxal Subjects Pooled|"Androxal (enclomiphene citrate), 12.5 mg or 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
208882|NCT01532414|O1|Outcome|Androxal Treated Subjects Pooled|"Androxal (enclomiphene citrate), 12.5 mg or 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
208883|NCT01532414|E3|Reported Event|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
208884|NCT01532414|E2|Reported Event|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
208885|NCT01532414|E1|Reported Event|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
208886|NCT01532362|B3|Baseline|Total|Total of all reporting groups
208887|NCT01532362|B2|Baseline|No Drug Intervention|no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
208888|NCT01532362|B1|Baseline|Apricoxib|As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
208889|NCT01532362|P2|Participant Flow|No Drug Intervention|no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
208890|NCT01532362|P1|Participant Flow|Apricoxib|As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
208891|NCT01532362|O2|Outcome|No Drug Intervention|no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
208892|NCT01532362|O1|Outcome|Apricoxib|As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
208893|NCT01532362|E2|Reported Event|No Drug Intervention|no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
208894|NCT01532362|E1|Reported Event|Apricoxib|As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
208895|NCT01532349|B3|Baseline|Total|Total of all reporting groups
208896|NCT01532349|B2|Baseline|4000 IU Vitamin D|Children were be randomly allocated to receive cholecalciferol supplementation 4000 IU/day (28,000 IU weekly) according to the KDOQI recommended supplementation for children with mild 25D deficiency. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
208897|NCT01532349|B1|Baseline|400 IU Vitamin D|Children were randomly allocated to receive cholecalciferol supplementation 400 IU/day (2,800 IU/weekly), which is the recommended dietary allowance. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
208898|NCT01532349|P2|Participant Flow|4000 IU Vitamin D|Children will be randomly allocated to receive cholecalciferol supplementation 4000 IU/day (28,000 IU weekly) according to the KDOQI recommended supplementation for children with mild 25D deficiency. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
208934|NCT01532128|O3|Outcome|Rasagiline Concomitant BIA 9-1067|Rasagiline concomitant BIA 9-1067.
208935|NCT01532128|O2|Outcome|Rasagiline 1 h After BIA 9-1067|Rasagiline 1 h after BIA 9-1067.
208900|NCT01532349|O2|Outcome|4000 IU Vitamin D|"Children were be randomly allocated to receive cholecalciferol supplementation 4000 IU/day (28,000 IU weekly) according to the KDOQI recommended supplementation for children with mild 25D deficiency. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.~Serum hepcidin was the primary outcome variable and was quantified at all visits."
208901|NCT01532349|O1|Outcome|400 IU Vitamin D|"Children were randomly allocated to receive cholecalciferol supplementation 400 IU/day (2,800 IU/weekly), which is the recommended dietary allowance. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.~Serum hepcidin was the primary outcome variable and was quantified at all visits."
208902|NCT01532349|E2|Reported Event|4000 IU Vitamin D|"Children were be randomly allocated to receive cholecalciferol supplementation 4000 IU/day (28,000 IU weekly) according to the KDOQI recommended supplementation for children with mild 25D deficiency. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.~Serum hepcidin was the primary outcome variable and was quantified at all visits."
208903|NCT01532349|E1|Reported Event|400 IU Vitamin D|"Children were randomly allocated to receive cholecalciferol supplementation 400 IU/day (2,800 IU/weekly), which is the recommended dietary allowance. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.~Serum hepcidin was the primary outcome variable and was quantified at all visits."
208904|NCT01532141|B4|Baseline|Total|Total of all reporting groups
208905|NCT01532141|B3|Baseline|Group 3|"Period 1: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)~Rasagiline: 1 mg rasagiline (single-dose)"
208906|NCT01532141|B2|Baseline|Group 2|"Period 1: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 alone Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)~Rasagiline: 1 mg rasagiline (single-dose)"
208907|NCT01532141|B1|Baseline|Group 1|"Period 1: 50 mg BIA 9-1067 alone Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)~Rasagiline: 1 mg rasagiline (single-dose)"
208908|NCT01532141|P3|Participant Flow|Group 3|"Period 1: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)~Rasagiline: 1 mg rasagiline (single-dose)"
208909|NCT01532141|P2|Participant Flow|Group 2|"Period 1: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 alone Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)~Rasagiline: 1 mg rasagiline (single-dose)"
208910|NCT01532141|P1|Participant Flow|Group 1|"Period 1: 50 mg BIA 9-1067 alone Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)~Rasagiline: 1 mg rasagiline (single-dose)"
208911|NCT01532141|O3|Outcome|BIA 9-1067 Concomitant Rasagiline|BIA 9-1067 concomitant rasagiline.
208912|NCT01532141|O2|Outcome|BIA 9-1067 1h Before Rasagiline|BIA 9-1067 1h before Rasagiline.
208913|NCT01532141|O1|Outcome|BIA 9-1067 Alone|BIA 9-1067 alone.
208914|NCT01532141|O3|Outcome|BIA 9-1067 Concomitant Rasagiline|BIA 9-1067 concomitant rasagiline.
208915|NCT01532141|O2|Outcome|BIA 9-1067 1h Before Rasagiline|BIA 9-1067 1h before Rasagiline.
208916|NCT01532141|O1|Outcome|BIA 9-1067 Alone|BIA 9-1067 alone.
208917|NCT01532141|O3|Outcome|BIA 9-1067 Concomitant Rasagiline|BIA 9-1067 concomitant rasagiline.
208918|NCT01532141|O2|Outcome|BIA 9-1067 1h Before Rasagiline|BIA 9-1067 1h before Rasagiline.
208919|NCT01532141|O1|Outcome|BIA 9-1067 Alone|BIA 9-1067 alone.
208920|NCT01532141|E4|Reported Event|BIA 9-1067 Concomitant Rasagiline|BIA 9-1067 concomitant rasagiline.
208921|NCT01532141|E3|Reported Event|BIA 9-1067 1h Before Rasagiline|BIA 9-1067 1h before Rasagiline.
208922|NCT01532141|E2|Reported Event|BIA 9-1067 Alone|BIA 9-1067 alone.
208923|NCT01532141|E1|Reported Event|Before Treatment|Before treatment.
208924|NCT01532128|B4|Baseline|Total|Total of all reporting groups
208925|NCT01532128|B3|Baseline|Group 3|"Period 1: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 2: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 3: rasagiline 1 mg~rasagiline: 1 mg rasagiline (single-dose)~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
208926|NCT01532128|B2|Baseline|Group 2|"Period 1: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 2: rasagiline 1 mg Period 3: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg~rasagiline: 1 mg rasagiline (single-dose)~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
208927|NCT01532128|B1|Baseline|Group 1|"Period 1: rasagiline 1 mg Period 2: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 3: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg~rasagiline: 1 mg rasagiline (single-dose)~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
208928|NCT01532128|P3|Participant Flow|Group 3|"Period 1: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 2: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 3: rasagiline 1 mg~rasagiline: 1 mg rasagiline (single-dose)~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
208929|NCT01532128|P2|Participant Flow|Group 2|"Period 1: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 2: rasagiline 1 mg Period 3: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg~rasagiline: 1 mg rasagiline (single-dose)~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
208930|NCT01532128|P1|Participant Flow|Group 1|"Period 1: rasagiline 1 mg Period 2: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 3: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg~rasagiline: 1 mg rasagiline (single-dose)~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
208931|NCT01532128|O3|Outcome|Rasagiline Concomitant BIA 9-1067|Rasagiline concomitant BIA 9-1067.
208932|NCT01532128|O2|Outcome|Rasagiline 1 h After BIA 9-1067|Rasagiline 1 h after BIA 9-1067.
208933|NCT01532128|O1|Outcome|Rasagiline Alone|Rasagiline alone.
208944|NCT01531998|B1|Baseline|Siltuximab + Bortezomib + Lenalidomide|Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
208945|NCT01531998|P1|Participant Flow|Siltuximab + Bortezomib + Lenalidomide|Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
208946|NCT01531998|O1|Outcome|Siltuximab + Bortezomib + Lenalidomide|Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
208947|NCT01531998|O1|Outcome|Siltuximab + Bortezomib + Lenalidomide|Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
208948|NCT01531998|E1|Reported Event|Siltuximab + Bortezomib + Lenalidomide|Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
208949|NCT01531725|B1|Baseline|BMS Implantation|Patients with a BMS implanted.
208950|NCT01531725|P1|Participant Flow|BMS Implantation|BMS implantation
208951|NCT01531725|O1|Outcome|BMS Implantation|BMS implantation
208952|NCT01531725|O1|Outcome|BMS Implantation|BMS implantation
208953|NCT01531725|E1|Reported Event|BMS Implantation|BMS implantation
208954|NCT01531673|B14|Baseline|Total|Total of all reporting groups
208955|NCT01531673|B13|Baseline|Group 7: VX-661 100 mg qd|All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
208956|NCT01531673|B12|Baseline|Group 7: Placebo|All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
208957|NCT01531673|B11|Baseline|Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h|All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
208958|NCT01531673|B10|Baseline|Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h|All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
208959|NCT01531673|B9|Baseline|Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h|All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
208960|NCT01531673|B8|Baseline|Group 5a: VX-661 150 mg qd|All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
208961|NCT01531673|B7|Baseline|Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h|All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
208962|NCT01531673|B6|Baseline|Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h|All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
208963|NCT01531673|B5|Baseline|Group 3a: VX-661 100 mg qd|All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
208964|NCT01531673|B4|Baseline|Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h|All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
208965|NCT01531673|B3|Baseline|Group 2a: VX-661 30 mg qd|All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
208966|NCT01531673|B2|Baseline|Group 1: VX-661 10 mg qd|All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
208967|NCT01531673|B1|Baseline|Group 1-6d Combined: Placebo|All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
208968|NCT01531673|P13|Participant Flow|Group 7: VX-661 100 mg qd|All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
208969|NCT01531673|P12|Participant Flow|Group 7: Placebo|All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
208970|NCT01531673|P11|Participant Flow|Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h|All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
210243|NCT01525667|E3|Reported Event|Placebo|Placebo: Single treatment, multiple injections
208971|NCT01531673|P10|Participant Flow|Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h|All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
208972|NCT01531673|P9|Participant Flow|Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h|All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
208973|NCT01531673|P8|Participant Flow|Group 5a: VX-661 150 mg qd|All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
208974|NCT01531673|P7|Participant Flow|Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h|All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
208975|NCT01531673|P6|Participant Flow|Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h|All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
208976|NCT01531673|P5|Participant Flow|Group 3a: VX-661 100 mg qd|All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
208977|NCT01531673|P4|Participant Flow|Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h|All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
208978|NCT01531673|P3|Participant Flow|Group 2a: VX-661 30 mg qd|All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet every 12 hours (q12h) for up to 28 days.
208979|NCT01531673|P2|Participant Flow|Group 1: VX-661 10 mg qd|All participants in group 1 who received VX-661 10 milligram (mg) tablet orally once daily (qd) for up to 28 days.
208980|NCT01531673|P1|Participant Flow|Group 1-6d Combined: Placebo|All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
208981|NCT01531673|O7|Outcome|Group 7: VX-661 100 mg qd|All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician prescribed Kalydeco for up to 28 days.
208982|NCT01531673|O6|Outcome|Group 6d: VX-661 50 mg q12h/ Ivacaftor 150 mg q12h|All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
208983|NCT01531673|O5|Outcome|Group 6a: VX-661 100 mg qd/ Ivacaftor 50 mg q12h|All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
208984|NCT01531673|O4|Outcome|Group 5b: VX-661 150 mg qd/ Ivacaftor 150 mg q12h|All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
208985|NCT01531673|O3|Outcome|Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h|All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
208986|NCT01531673|O2|Outcome|Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h|All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
208987|NCT01531673|O1|Outcome|Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h|All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
208988|NCT01531673|O4|Outcome|Group 5a: VX-661 150 mg qd|All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
208989|NCT01531673|O3|Outcome|Group 3a: VX-661 100 mg qd|All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
208990|NCT01531673|O2|Outcome|Group 2a: VX-661 30 mg qd|All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
208991|NCT01531673|O1|Outcome|Group 1: VX-661 10 mg qd|All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
208992|NCT01531673|O2|Outcome|Group 7: VX-661 100 mg qd|All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
208993|NCT01531673|O1|Outcome|Group 7: Placebo|All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
208994|NCT01531673|O3|Outcome|Group 4 and 6 Combined: Placebo|All participants in group 4, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
208995|NCT01531673|O2|Outcome|Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h|All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
208996|NCT01531673|O1|Outcome|Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h|All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
208997|NCT01531673|O9|Outcome|Group 1-5b Combined Placebo|All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a and 5b who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
208998|NCT01531673|O8|Outcome|Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h|All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
208999|NCT01531673|O7|Outcome|Group 5a: VX-661 150 mg qd|All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
209000|NCT01531673|O6|Outcome|Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h|All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209001|NCT01531673|O5|Outcome|Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h|All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209002|NCT01531673|O4|Outcome|Group 3a: VX-661 100 mg qd|All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
209003|NCT01531673|O3|Outcome|Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h|All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209004|NCT01531673|O2|Outcome|Group 2a: VX-661 30 mg qd|All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
209005|NCT01531673|O1|Outcome|Group 1: VX-661 10 mg qd|All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
209006|NCT01531673|O2|Outcome|Group 7: VX-661 100 mg qd|All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
209007|NCT01531673|O1|Outcome|Group 7: Placebo|All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
209008|NCT01531673|O3|Outcome|Group 4 and 6 Combined: Placebo|All participants in group 4, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
209009|NCT01531673|O2|Outcome|Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h|All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209010|NCT01531673|O1|Outcome|Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h|All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
209011|NCT01531673|O9|Outcome|Group 1-5b Combined Placebo|All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a and 5b who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
209012|NCT01531673|O8|Outcome|Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h|All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209013|NCT01531673|O7|Outcome|Group 5a: VX-661 150 mg qd|All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
209014|NCT01531673|O6|Outcome|Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h|All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209015|NCT01531673|O5|Outcome|Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h|All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209016|NCT01531673|O4|Outcome|Group 3a: VX-661 100 mg qd|All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
209017|NCT01531673|O3|Outcome|Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h|All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209018|NCT01531673|O2|Outcome|Group 2a: VX-661 30 mg qd|All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
209019|NCT01531673|O1|Outcome|Group 1: VX-661 10 mg qd|All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
209020|NCT01531673|O2|Outcome|Group 7: VX-661 100 mg qd|All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
209021|NCT01531673|O1|Outcome|Group 7: Placebo|All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
209022|NCT01531673|O3|Outcome|Group 4 and 6 Combined: Placebo|All participants in group 4, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
209023|NCT01531673|O2|Outcome|Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h|All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209024|NCT01531673|O1|Outcome|Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h|All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
209025|NCT01531673|O9|Outcome|Group 1-5b Combined Placebo|All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a and 5b who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
209026|NCT01531673|O8|Outcome|Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h|All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209027|NCT01531673|O7|Outcome|Group 5a: VX-661 150 mg qd|All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
209028|NCT01531673|O6|Outcome|Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h|All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209029|NCT01531673|O5|Outcome|Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h|All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209030|NCT01531673|O4|Outcome|Group 3a: VX-661 100 mg qd|All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
209031|NCT01531673|O3|Outcome|Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h|All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209032|NCT01531673|O2|Outcome|Group 2a: VX-661 30 mg qd|All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
209033|NCT01531673|O1|Outcome|Group 1: VX-661 10 mg qd|All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
209034|NCT01531673|O2|Outcome|Group 7: VX-661 100 mg qd|All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
209035|NCT01531673|O1|Outcome|Group 7: Placebo|All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
209036|NCT01531673|O3|Outcome|Group 4 and 6 Combined: Placebo|All participants in group 4, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
209037|NCT01531673|O2|Outcome|Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h|All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209038|NCT01531673|O1|Outcome|Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h|All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
209039|NCT01531673|O9|Outcome|Group 1-5b Combined Placebo|All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a and 5b who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
209040|NCT01531673|O8|Outcome|Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h|All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209041|NCT01531673|O7|Outcome|Group 5a: VX-661 150 mg qd|All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
209042|NCT01531673|O6|Outcome|Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h|All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209043|NCT01531673|O5|Outcome|Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h|All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209044|NCT01531673|O4|Outcome|Group 3a: VX-661 100 mg qd|All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
209045|NCT01531673|O3|Outcome|Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h|All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209046|NCT01531673|O2|Outcome|Group 2a: VX-661 30 mg qd|All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
209047|NCT01531673|O1|Outcome|Group 1: VX-661 10 mg qd|All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
209048|NCT01531673|O2|Outcome|Group 7: VX-661 100 mg qd|All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
209049|NCT01531673|O1|Outcome|Group 7: Placebo|All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
209050|NCT01531673|O3|Outcome|Group 4 and 6 Combined: Placebo|All participants in group 4, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
209051|NCT01531673|O2|Outcome|Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h|All participants in group 6d who received VX-661 50 mg tablet q12h and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209052|NCT01531673|O1|Outcome|Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h|All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
209053|NCT01531673|O9|Outcome|Group 1-5b Combined Placebo|All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a and 5b who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
209054|NCT01531673|O8|Outcome|Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h|All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209055|NCT01531673|O7|Outcome|Group 5a: VX-661 150 mg qd|All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
209056|NCT01531673|O6|Outcome|Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h|All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209057|NCT01531673|O5|Outcome|Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h|All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209058|NCT01531673|O4|Outcome|Group 3a: VX-661 100 mg qd|All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
209059|NCT01531673|O3|Outcome|Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h|All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209060|NCT01531673|O2|Outcome|Group 2a: VX-661 30 mg qd|All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
209061|NCT01531673|O1|Outcome|Group 1: VX-661 10 mg qd|All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
209062|NCT01531673|O13|Outcome|Group 7: VX-661 100 mg qd|All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
209063|NCT01531673|O12|Outcome|Group 7: Placebo|All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
209064|NCT01531673|O11|Outcome|Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h|All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209065|NCT01531673|O10|Outcome|Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h|All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
209066|NCT01531673|O9|Outcome|Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h|All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209067|NCT01531673|O8|Outcome|Group 5a: VX-661 150 mg qd|All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
209068|NCT01531673|O7|Outcome|Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h|All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209069|NCT01531673|O6|Outcome|Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h|All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209070|NCT01531673|O5|Outcome|Group 3a: VX-661 100 mg qd|All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
209071|NCT01531673|O4|Outcome|Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h|All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209072|NCT01531673|O3|Outcome|Group 2a: VX-661 30 mg qd|All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
209073|NCT01531673|O2|Outcome|Group 1: VX-661 10 mg qd|All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
209074|NCT01531673|O1|Outcome|Group 1-6d Combined: Placebo|All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
209075|NCT01531673|E13|Reported Event|Group 7: VX-661 100 mg qd|All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
209076|NCT01531673|E12|Reported Event|Group 7: Placebo|All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
209077|NCT01531673|E11|Reported Event|Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h|All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209078|NCT01531673|E10|Reported Event|Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h|All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
209079|NCT01531673|E9|Reported Event|Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h|All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209080|NCT01531673|E8|Reported Event|Group 5a: VX-661 150 mg qd|All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
209081|NCT01531673|E7|Reported Event|Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h|All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209082|NCT01531673|E6|Reported Event|Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h|All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209083|NCT01531673|E5|Reported Event|Group 3a: VX-661 100 mg qd|All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
209084|NCT01531673|E4|Reported Event|Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h|All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
209085|NCT01531673|E3|Reported Event|Group 2a: VX-661 30 mg qd|All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
209086|NCT01531673|E2|Reported Event|Group 1: VX-661 10 mg qd|All participants in group 1 who received VX-661 10 milligram (mg) tablet orally qd for up to 28 days.
209087|NCT01531673|E1|Reported Event|Group 1-6d Combined: Placebo|All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
209088|NCT01531387|B3|Baseline|Total|Total of all reporting groups
209089|NCT01531387|B2|Baseline|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
209090|NCT01531387|B1|Baseline|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
209091|NCT01531387|P2|Participant Flow|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
209092|NCT01531387|P1|Participant Flow|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
209093|NCT01531387|O2|Outcome|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
209094|NCT01531387|O1|Outcome|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
209095|NCT01531387|O2|Outcome|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
209096|NCT01531387|O1|Outcome|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
209097|NCT01531387|O2|Outcome|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
209098|NCT01531387|O1|Outcome|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
209099|NCT01531387|O2|Outcome|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
209100|NCT01531387|O1|Outcome|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
209101|NCT01531387|O2|Outcome|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
209102|NCT01531387|O1|Outcome|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
209103|NCT01531387|E2|Reported Event|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
209104|NCT01531387|E1|Reported Event|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
209105|NCT01531374|B4|Baseline|Total|Total of all reporting groups
209106|NCT01531374|B3|Baseline|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209107|NCT01531374|B2|Baseline|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209108|NCT01531374|B1|Baseline|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209109|NCT01531374|P3|Participant Flow|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209110|NCT01531374|P2|Participant Flow|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209111|NCT01531374|P1|Participant Flow|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209112|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209113|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209114|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209115|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209116|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209117|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209118|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209119|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209120|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209121|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209122|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209123|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209124|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209125|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209126|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209127|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209128|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209129|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209130|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209131|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209132|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209133|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209134|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209135|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209136|NCT01531374|O2|Outcome|High Risk: Implanted Cohort|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209137|NCT01531374|O1|Outcome|Extreme Risk: Implanted Cohort|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209138|NCT01531374|O2|Outcome|High Risk: Implanted Cohort|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209139|NCT01531374|O1|Outcome|Extreme Risk: Implanted Cohort|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209140|NCT01531374|O2|Outcome|High Risk: Implanted Cohort|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209141|NCT01531374|O1|Outcome|Extreme Risk: Implanted Cohort|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209142|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209143|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209144|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209145|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209146|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209147|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209148|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209149|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209150|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209151|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209152|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209153|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209154|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209155|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209156|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209157|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209841|NCT01528605|E1|Reported Event|Placebo|"starch in hard shell gelatine capsules~placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
209158|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209159|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209160|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209161|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209162|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209163|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209164|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209165|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209166|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209167|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209168|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209169|NCT01531374|E3|Reported Event|High Risk: TAVI|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209170|NCT01531374|E2|Reported Event|Extreme Risk: TAVI Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209171|NCT01531374|E1|Reported Event|Extreme Risk: TAVI Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
209172|NCT01531335|B3|Baseline|Total|Total of all reporting groups
209173|NCT01531335|B2|Baseline|Hypocaloric Hyperproteic Nutrition|"15 kcal per kg of body weight and 1.7 grams of protein per kg~Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg."
209174|NCT01531335|B1|Baseline|Standard Care|"Patients will receive normal nutritional regime of around 25 kcal per kg.~Standard care: 25 kcal per kg of body weight"
209175|NCT01531335|P2|Participant Flow|Hypocaloric Hyperproteic Nutrition|"15 kcal per kg of body weight and 1.7 grams of protein per kg~Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg."
209176|NCT01531335|P1|Participant Flow|Standard Care|"Patients will receive normal nutritional regime of around 25 kcal per kg.~Standard care: 25 kcal per kg of body weight"
209177|NCT01531335|O2|Outcome|Hypocaloric Hyperproteic Nutrition|"15 kcal per kg of body weight and 1.7 grams of protein per kg~Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg."
209178|NCT01531335|O1|Outcome|Standard Care|"Patients will receive normal nutritional regime of around 25 kcal per kg.~Standard care: 25 kcal per kg of body weight"
209179|NCT01531335|O2|Outcome|Hypocaloric Hyperproteic Nutrition|"15 kcal per kg of body weight and 1.7 grams of protein per kg~Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg."
209180|NCT01531335|O1|Outcome|Standard Care|"Patients will receive normal nutritional regime of around 25 kcal per kg.~Standard care: 25 kcal per kg of body weight"
209181|NCT01531335|E2|Reported Event|Hypocaloric Hyperproteic Nutrition|"15 kcal per kg of body weight and 1.7 grams of protein per kg~Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg."
209182|NCT01531335|E1|Reported Event|Standard Care|"Patients will receive normal nutritional regime of around 25 kcal per kg.~Standard care: 25 kcal per kg of body weight"
209183|NCT01531205|B1|Baseline|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
209184|NCT01531205|P1|Participant Flow|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
209185|NCT01531205|O2|Outcome|Participant Two|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
209186|NCT01531205|O1|Outcome|Participant One|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
209187|NCT01531205|O1|Outcome|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
209188|NCT01531205|O1|Outcome|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
209189|NCT01531205|O1|Outcome|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
209190|NCT01531205|O1|Outcome|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
209191|NCT01531205|E1|Reported Event|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
209192|NCT01530997|B1|Baseline|De-escalated Radiation and Chemotherapy|"Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.~Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively."
209193|NCT01530997|P1|Participant Flow|Single Intervention|"Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.~Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively."
209194|NCT01530997|O2|Outcome|Post-treatment|This data was collected 4-8 weeks after chemoradiation therapy
209195|NCT01530997|O1|Outcome|Pre-treatment|This data was collected before the treatment.
209196|NCT01530997|O3|Outcome|Post-Surgery|This data was collected at the first follow-up post surgery.
209197|NCT01530997|O2|Outcome|6-8 Weeks Post-Treatment|This data was collected 6-8 weeks post-chemoradiotherapy.
209198|NCT01530997|O1|Outcome|Baseline|This data was collected pre-chemoradiotherapy treatment.
209199|NCT01530997|O3|Outcome|Post-Surgery|This data was collected at the first follow-up post-surgery.
209200|NCT01530997|O2|Outcome|6-8 Weeks Post-Treatment|This data was collected 6-8 weeks post-chemoradiotherapy.
209201|NCT01530997|O1|Outcome|Baseline|This data was collected pre-chemoradiotherapy treatment.
209202|NCT01530997|O3|Outcome|Post-Surgery|This data was collected at the first follow-up post-surgery.
209203|NCT01530997|O2|Outcome|6-8 Weeks Post-Treatment|This data was collected 6-8 weeks post-chemoradiotherapy.
209204|NCT01530997|O1|Outcome|Baseline|This data was collected pre-chemoradiotherapy treatment.
209205|NCT01530997|O1|Outcome|Single Intervention|"Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.~Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively."
209206|NCT01530997|O1|Outcome|Single Intervention|"Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.~Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively."
209207|NCT01530997|O1|Outcome|Single Intervention|"Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.~Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively."
209221|NCT01530880|O1|Outcome|Intravenous Ibuprofen|"Patients assigned to the ibuprofen treatment group will receive a 400 mg IV ibuprofen bolus over 30 minutes followed by an infusion of ibuprofen at 85 mg/hr.~Intravenous Ibuprofen: Ibuprofen 400 mg/100 mL intravenous (IV) over 30 minutes, followed by a continuous infusion of 2000 mg/500 mL at 85 mg/hour (21 mL/hour) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first"
209208|NCT01530997|O1|Outcome|Single Intervention|"Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.~Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively."
209209|NCT01530997|O1|Outcome|De-escalated Radiation and Chemotherapy|"Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.~Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively."
209210|NCT01530997|O1|Outcome|De-escalated Radiation and Chemotherapy|"Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.~Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively."
209211|NCT01530997|E1|Reported Event|Single Intervention|"Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.~Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively"
209212|NCT01530880|B1|Baseline|All Subjects|Includes subjects from both arms.
209213|NCT01530880|P1|Participant Flow|All Subjects|Includes subjects from both arms as this information is only available for all subjects and not per arm.
209214|NCT01530880|O2|Outcome|Standard of Care|"Patients assigned to the standard of care group will be given 650 mg of oral acetaminophen and continue to receive 650 mg of oral acetaminophen every 6 hours as needed to maintain temperature < 38.3 C (100.9 F).~Acetaminophen (Standard of Care): Acetaminophen 650 mg via oral/nasogastric tube every 6 hours as needed for T>=38.3 C (100.9 F) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first."
209215|NCT01530880|O1|Outcome|Intravenous Ibuprofen|"Patients assigned to the ibuprofen treatment group will receive a 400 mg IV ibuprofen bolus over 30 minutes followed by an infusion of ibuprofen at 85 mg/hr.~Intravenous Ibuprofen: Ibuprofen 400 mg/100 mL intravenous (IV) over 30 minutes, followed by a continuous infusion of 2000 mg/500 mL at 85 mg/hour (21 mL/hour) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first"
209216|NCT01530880|O2|Outcome|Standard of Care|"Patients assigned to the standard of care group will be given 650 mg of oral acetaminophen and continue to receive 650 mg of oral acetaminophen every 6 hours as needed to maintain temperature < 38.3 C (100.9 F).~Acetaminophen (Standard of Care): Acetaminophen 650 mg via oral/nasogastric tube every 6 hours as needed for T>=38.3 C (100.9 F) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first."
209217|NCT01530880|O1|Outcome|Intravenous Ibuprofen|"Patients assigned to the ibuprofen treatment group will receive a 400 mg IV ibuprofen bolus over 30 minutes followed by an infusion of ibuprofen at 85 mg/hr.~Intravenous Ibuprofen: Ibuprofen 400 mg/100 mL intravenous (IV) over 30 minutes, followed by a continuous infusion of 2000 mg/500 mL at 85 mg/hour (21 mL/hour) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first"
209218|NCT01530880|O2|Outcome|Standard of Care|"Patients assigned to the standard of care group will be given 650 mg of oral acetaminophen and continue to receive 650 mg of oral acetaminophen every 6 hours as needed to maintain temperature < 38.3 C (100.9 F).~Acetaminophen (Standard of Care): Acetaminophen 650 mg via oral/nasogastric tube every 6 hours as needed for T>=38.3 C (100.9 F) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first."
209219|NCT01530880|O1|Outcome|Intravenous Ibuprofen|"Patients assigned to the ibuprofen treatment group will receive a 400 mg IV ibuprofen bolus over 30 minutes followed by an infusion of ibuprofen at 85 mg/hr.~Intravenous Ibuprofen: Ibuprofen 400 mg/100 mL intravenous (IV) over 30 minutes, followed by a continuous infusion of 2000 mg/500 mL at 85 mg/hour (21 mL/hour) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first"
209220|NCT01530880|O2|Outcome|Standard of Care|"Patients assigned to the standard of care group will be given 650 mg of oral acetaminophen and continue to receive 650 mg of oral acetaminophen every 6 hours as needed to maintain temperature < 38.3 C (100.9 F).~Acetaminophen (Standard of Care): Acetaminophen 650 mg via oral/nasogastric tube every 6 hours as needed for T>=38.3 C (100.9 F) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first."
209222|NCT01530880|E1|Reported Event|All Subjects|Includes subjects from both arms as this information is only available for all subjects and not per arm.
209224|NCT01530477|B3|Baseline|Skeletal and Body Composition|"Skeletal and Body Composition was not a cohort that was actively recruited to, it is a cohort for reporting purposes. Subjects were able to consent and enroll to both Skeletal and Body Composition cohorts and these subjects will be counted for under this joint cohort."
209225|NCT01530477|B2|Baseline|Body Composition|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Body Composition Cohort.
209226|NCT01530477|B1|Baseline|Skeletal|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Skeletal Cohort.
209227|NCT01530477|P3|Participant Flow|Skeletal & Body Composition|"Skeletal & Body Composition was not a cohort that was actively recruited to, it is a cohort for reporting purposes. Subjects were able to consent and enroll to both Skeletal and Body Composition cohorts and these subjects will be counted for under this joint cohort."
209228|NCT01530477|P2|Participant Flow|Body Composition Only|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Body Composition Cohort.
209229|NCT01530477|P1|Participant Flow|Skeletal|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Skeletal Cohort.
209230|NCT01530477|O2|Outcome|Body Composition Only|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Body Composition Cohort.
209231|NCT01530477|O1|Outcome|Skeletal|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Skeletal Cohort.
209232|NCT01530477|E2|Reported Event|Body Composition|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects).
209233|NCT01530477|E1|Reported Event|Skeletal|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects).
209234|NCT01530464|B3|Baseline|Total|Total of all reporting groups
209235|NCT01530464|B2|Baseline|Sequence B|"Period 1: Ambrisentan 5 mg orally, followed by 48 h washout period. Period 2: Aminophylline 500 mg orally (corresponding to 395 mg theophylline), followed by 48 h washout period.~Period 3: Aminophylline, 500 mg plus Ambrisentan, 5 mg orally, followed by 48 h washout period."
209236|NCT01530464|B1|Baseline|Sequence A|"Period 1: Aminophylline 500 mg orally (corresponding to 395 mg theophylline), followed by 48 h washout period.~Period 2: Ambrisentan 5 mg orally, followed by 48 h washout period.. Period 3: Aminophylline, 500 mg plus Ambrisentan, 5 mg orally, followed by 48 h washout period."
209237|NCT01530464|P2|Participant Flow|Sequence B|Period 1: First intervention (Ambrisentan 5mg, 24h) Period 2: Washout (24 hours) Period 3: Second intervention (Aminophylline 500mg, 24h) Period 4: Washout (24h) Period 5: Third intervention (Aminophylline 500mg plus ambrisentan 5mg, 24h) Period 6: Washout (24h)
209238|NCT01530464|P1|Participant Flow|Sequence A|Period 1: First intervention (Aminophylline 500mg, 24h) Period 2: Washout (24 hours) Period 3: Second intervention (Ambrisentan 5mg, 24h) Period 4: Washout (24h) Period 5: Third intervention (Aminophylline 500mg plus ambrisentan 5mg, 24h) Period 6: Washout (24h)
209239|NCT01530464|O4|Outcome|Ambrisentan in Presence of Aminophylline|
209240|NCT01530464|O3|Outcome|Ambrisentan Alone|
209241|NCT01530464|O2|Outcome|Aminophylline in Presence of Ambrisentan|
209242|NCT01530464|O1|Outcome|Aminophylline Alone|
209243|NCT01530464|O4|Outcome|Ambrisentan in Presence of Aminophylline|
209244|NCT01530464|O3|Outcome|Ambrisentan Alone|
209245|NCT01530464|O2|Outcome|Aminophylline in Presence of Ambrisentan|
209246|NCT01530464|O1|Outcome|Aminophylline Alone|
209247|NCT01530464|O4|Outcome|Ambrisentan in Presence of Aminophylline|
209248|NCT01530464|O3|Outcome|Ambrisentan Alone|
209249|NCT01530464|O2|Outcome|Aminophylline in Presence of Ambrisentan|
209250|NCT01530464|O1|Outcome|Aminophylline Alone|
209251|NCT01530464|O4|Outcome|Ambrisentan in Presence of Aminophylline|
209252|NCT01530464|O3|Outcome|Ambrisentan Alone|
209253|NCT01530464|O2|Outcome|Aminophylline in Presence of Ambrisentan|
209254|NCT01530464|O1|Outcome|Aminophylline Alone|
209255|NCT01530464|O4|Outcome|Ambrisentan in Presence of Aminophylline|
209256|NCT01530464|O3|Outcome|Ambrisentan Alone|
209257|NCT01530464|O2|Outcome|Aminophylline in Presence of Ambrisentan|
209258|NCT01530464|O1|Outcome|Aminophylline Alone|
210244|NCT01525667|E2|Reported Event|300M PLX-PAD|PLX-PAD high dose: Single treatment, multiple injections
209259|NCT01530464|O2|Outcome|Sequence B|"Period 1: Ambrisentan 5 mg orally, followed by 48 h washout period. Period 2: Aminophylline 500 mg orally (corresponding to 395 mg theophylline), followed by 48 h washout period.~Period 3: Aminophylline, 500 mg plus Ambrisentan, 5 mg orally, followed by 48 h washout period."
209260|NCT01530464|O1|Outcome|Sequence A|"Period 1: Aminophylline 500 mg orally (corresponding to 395 mg theophylline), followed by 48 h washout period.~Period 2: Ambrisentan 5 mg orally, followed by 48 h washout period.. Period 3: Aminophylline, 500 mg plus Ambrisentan, 5 mg orally, followed by 48 h washout period."
209261|NCT01530464|E3|Reported Event|Combined Aminophylline and Ambrisentan|Combined single doses of Aminophylline 400 mg and ambrisentan 5 mg, followed by a 48 h washout period
209262|NCT01530464|E2|Reported Event|Ambrisentan Only|Ambrisentan 5 mg orally, followed by 48 h washout period. lowed by 48 h washout period.
209263|NCT01530464|E1|Reported Event|Aminophylline Only|Aminophylline 500 mg orally (corresponding to 395 mg theophylline), followed by 48 h washout period.
209264|NCT01530399|B7|Baseline|Total|Total of all reporting groups
209265|NCT01530399|B6|Baseline|Tranexamic Acid|saline: A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. In addition, the CPB reservoir will be primed with saline. The flow rates will be the same as for MDCO-2010.
209266|NCT01530399|B5|Baseline|Saline|Tranexamic Acid: Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.
209267|NCT01530399|B4|Baseline|MDCO 4|MDCO-2010 Dose 4: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 4: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume
209268|NCT01530399|B3|Baseline|MDCO 3|MDCO-2010 Dose 3: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 3: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume
209269|NCT01530399|B2|Baseline|MDCO 2|MDCO-2010 Dose 2: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 2: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume
209270|NCT01530399|B1|Baseline|MDCO 1|MDCO-2010 Dose 1: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 1: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume
209271|NCT01530399|P6|Participant Flow|Tranexamic Acid|saline: A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. In addition, the CPB reservoir will be primed with saline. The flow rates will be the same as for MDCO-2010.
209272|NCT01530399|P5|Participant Flow|Saline|Tranexamic Acid: Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.
209273|NCT01530399|P4|Participant Flow|MDCO 4|MDCO-2010 Dose 4: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 4: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume
209274|NCT01530399|P3|Participant Flow|MDCO 3|MDCO-2010 Dose 3: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 3: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume
209275|NCT01530399|P2|Participant Flow|MDCO 2|MDCO-2010 Dose 2: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 2: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume
209276|NCT01530399|P1|Participant Flow|MDCO 1|MDCO-2010 Dose 1: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 1: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume
209277|NCT01530399|O6|Outcome|Tranexamic Acid|saline: A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. In addition, the CPB reservoir will be primed with saline. The flow rates will be the same as for MDCO-2010.
209278|NCT01530399|O5|Outcome|Saline|Tranexamic Acid: Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.
209279|NCT01530399|O4|Outcome|MDCO 4|MDCO-2010 Dose 4: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 4: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume
209280|NCT01530399|O3|Outcome|MDCO 3|MDCO-2010 Dose 3: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 3: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume
209281|NCT01530399|O2|Outcome|MDCO 2|MDCO-2010 Dose 2: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 2: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume
209282|NCT01530399|O1|Outcome|MDCO 1|MDCO-2010 Dose 1: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 1: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume
209283|NCT01530399|E6|Reported Event|Tranexamic Acid|saline: A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. In addition, the CPB reservoir will be primed with saline. The flow rates will be the same as for MDCO-2010.
209284|NCT01530399|E5|Reported Event|Saline|Tranexamic Acid: Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.
209842|NCT01528592|B1|Baseline|On / Off Medication|Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
209285|NCT01530399|E4|Reported Event|MDCO 4|MDCO-2010 Dose 4: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 4: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume
209286|NCT01530399|E3|Reported Event|MDCO 3|MDCO-2010 Dose 3: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 3: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume
209287|NCT01530399|E2|Reported Event|MDCO 2|MDCO-2010 Dose 2: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 2: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume
209288|NCT01530399|E1|Reported Event|MDCO 1|MDCO-2010 Dose 1: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 1: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume
209289|NCT01530334|B1|Baseline|Gefitinib|250 mg/die, oral
209290|NCT01530334|P1|Participant Flow|Gefitinib|250 mg/die, oral
209291|NCT01530334|O1|Outcome|Gefitinib|250 mg/die, oral
209292|NCT01530334|O1|Outcome|Gefitinib|250 mg/die, oral
209293|NCT01530334|O1|Outcome|Gefitinib|250 mg/die, oral
209294|NCT01530334|O1|Outcome|Gefitinib|250 mg/die, oral
209295|NCT01530334|O1|Outcome|Gefitinib|250 mg/die, oral
209296|NCT01530334|O1|Outcome|Gefitinib|250 mg/die, oral
209297|NCT01530334|E1|Reported Event|Gefitinib|250 mg/die, oral
209298|NCT01530243|B5|Baseline|Total|Total of all reporting groups
209299|NCT01530243|B4|Baseline|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
209300|NCT01530243|B3|Baseline|Tolterodine|Tolterodine: 2 mg daily
209301|NCT01530243|B2|Baseline|Terazosin|Terazosine: 2 mg BID
209302|NCT01530243|B1|Baseline|Placebo|Placebo: same as tolterodine and terazosin dose
209303|NCT01530243|P4|Participant Flow|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
209304|NCT01530243|P3|Participant Flow|Tolterodine|Tolterodine: 2 mg daily
209305|NCT01530243|P2|Participant Flow|Terazosin|Terazosin: 2 mg BID
209306|NCT01530243|P1|Participant Flow|Placebo|Placebo: same as tolterodine and terazosin dose
209307|NCT01530243|O4|Outcome|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
209308|NCT01530243|O3|Outcome|Tolterodine|Tolterodine: 2 mg daily
209309|NCT01530243|O2|Outcome|Terazosin|Terazosin: 2 mg BID
209310|NCT01530243|O1|Outcome|Placebo|Placebo: same as tolterodine and terazosin dose
209311|NCT01530243|O4|Outcome|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
209312|NCT01530243|O3|Outcome|Tolterodine|Tolterodine: 2 mg daily
209313|NCT01530243|O2|Outcome|Terazosin|Terazosine: 2 mg BID
209314|NCT01530243|O1|Outcome|Placebo|Placebo: same as tolterodine and terazosin dose
209315|NCT01530243|O4|Outcome|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
209316|NCT01530243|O3|Outcome|Tolterodine|Tolterodine: 2 mg daily
209317|NCT01530243|O2|Outcome|Terazosin|Terazosine: 2 mg BID
209318|NCT01530243|O1|Outcome|Placebo|Placebo: same as tolterodine and terazosin dose
209319|NCT01530243|E4|Reported Event|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
209320|NCT01530243|E3|Reported Event|Tolterodine|Tolterodine: 2 mg daily
209321|NCT01530243|E2|Reported Event|Terazosin|Terazosin: 2 mg BID
209322|NCT01530243|E1|Reported Event|Placebo|Placebo: same as tolterodine and terazosin dose
209323|NCT01530087|B1|Baseline|Subjects With Ileostomy or Colostomy|"CASTLE Barrier ostomy device~CASTLE barrier: Prototype barrier to be used in place of current two piece device"
209324|NCT01530087|P1|Participant Flow|Subjects With Ileostomy or Colostomy|"CASTLE Barrier ostomy device~CASTLE barrier: Prototype barrier to be used in place of current two piece device"
209325|NCT01530087|O1|Outcome|Treatment|"CASTLE Barrier~CASTLE barrier: Prototype barrier to be used in place of current two piece device"
209326|NCT01530087|O1|Outcome|Treatment|CASTLE Barrier: Prototype barrier used in place of previous two piece device
209327|NCT01530087|E1|Reported Event|Subjects With Ileostomy or Colostomy|"CASTLE Barrier ostomy device~CASTLE barrier: Prototype barrier to be used in place of current two piece device"
209328|NCT01529827|B1|Baseline|Treatment (Reduced Intensity Allogeneic PBSCT)|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6.~fludarabine phosphate: Given IV~melphalan: Given IV~total-body irradiation: Undergo TBI~tacrolimus: Given IV or PO~mycophenolate mofetil: Given IV or PO~methotrexate: Given IV~laboratory biomarker analysis: Correlative studies~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo PBSCT"
209329|NCT01529827|P1|Participant Flow|Treatment (Reduced Intensity Allogeneic PBSCT)|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6.~fludarabine phosphate: Given IV~melphalan: Given IV~total-body irradiation: Undergo TBI~tacrolimus: Given IV or PO~mycophenolate mofetil: Given IV or PO~methotrexate: Given IV~laboratory biomarker analysis: Correlative studies~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo PBSCT"
209348|NCT01529645|P8|Participant Flow|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
210245|NCT01525667|E1|Reported Event|150M PLX-PAD|PLX-PAD low dose: Single treatment, multiple injections
209330|NCT01529827|O1|Outcome|Treatment (Reduced Intensity Allogeneic PBSCT)|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6.~fludarabine phosphate: Given IV~melphalan: Given IV~total-body irradiation: Undergo TBI~tacrolimus: Given IV or PO~mycophenolate mofetil: Given IV or PO~methotrexate: Given IV~laboratory biomarker analysis: Correlative studies~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo PBSCT"
209331|NCT01529827|O1|Outcome|Treatment (Reduced Intensity Allogeneic PBSCT)|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6.~fludarabine phosphate: Given IV~melphalan: Given IV~total-body irradiation: Undergo TBI~tacrolimus: Given IV or PO~mycophenolate mofetil: Given IV or PO~methotrexate: Given IV~laboratory biomarker analysis: Correlative studies~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo PBSCT"
209332|NCT01529827|O1|Outcome|Treatment (Reduced Intensity Allogeneic PBSCT)|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6.~fludarabine phosphate: Given IV~melphalan: Given IV~total-body irradiation: Undergo TBI~tacrolimus: Given IV or PO~mycophenolate mofetil: Given IV or PO~methotrexate: Given IV~laboratory biomarker analysis: Correlative studies~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo PBSCT"
209333|NCT01529827|O1|Outcome|Treatment (Reduced Intensity Allogeneic PBSCT)|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6.~fludarabine phosphate: Given IV~melphalan: Given IV~total-body irradiation: Undergo TBI~tacrolimus: Given IV or PO~mycophenolate mofetil: Given IV or PO~methotrexate: Given IV~laboratory biomarker analysis: Correlative studies~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo PBSCT"
209334|NCT01529827|E1|Reported Event|Treatment (Reduced Intensity Allogeneic PBSCT)|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6.~fludarabine phosphate: Given IV~melphalan: Given IV~total-body irradiation: Undergo TBI~tacrolimus: Given IV or PO~mycophenolate mofetil: Given IV or PO~methotrexate: Given IV~laboratory biomarker analysis: Correlative studies~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo PBSCT"
209335|NCT01529645|B11|Baseline|Total|Total of all reporting groups
209336|NCT01529645|B10|Baseline|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
209337|NCT01529645|B9|Baseline|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209338|NCT01529645|B8|Baseline|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209339|NCT01529645|B7|Baseline|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209340|NCT01529645|B6|Baseline|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209341|NCT01529645|B5|Baseline|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209342|NCT01529645|B4|Baseline|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209343|NCT01529645|B3|Baseline|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
209344|NCT01529645|B2|Baseline|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
209345|NCT01529645|B1|Baseline|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
209346|NCT01529645|P10|Participant Flow|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
209347|NCT01529645|P9|Participant Flow|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209513|NCT01529450|B1|Baseline|Refractory Group|"Patients previously treated with non-LDE225 Smo inhibitor who were refractory.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
209349|NCT01529645|P7|Participant Flow|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209350|NCT01529645|P6|Participant Flow|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209351|NCT01529645|P5|Participant Flow|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209352|NCT01529645|P4|Participant Flow|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on day 1 of this study.
209353|NCT01529645|P3|Participant Flow|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
209354|NCT01529645|P2|Participant Flow|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
209355|NCT01529645|P1|Participant Flow|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
209356|NCT01529645|O10|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
209357|NCT01529645|O9|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209358|NCT01529645|O8|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209359|NCT01529645|O7|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209360|NCT01529645|O6|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209361|NCT01529645|O5|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209362|NCT01529645|O4|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209363|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
209364|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
209365|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
209366|NCT01529645|O4|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
209367|NCT01529645|O3|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209368|NCT01529645|O2|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209369|NCT01529645|O1|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209370|NCT01529645|O4|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day1 of this study.
209371|NCT01529645|O3|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209372|NCT01529645|O2|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209373|NCT01529645|O1|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209374|NCT01529645|O4|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day1 of this study.
209375|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
209376|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
209377|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
209378|NCT01529645|O10|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
209379|NCT01529645|O9|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209380|NCT01529645|O8|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209381|NCT01529645|O7|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209382|NCT01529645|O6|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209383|NCT01529645|O5|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209384|NCT01529645|O4|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209385|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
209386|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
209387|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
209388|NCT01529645|O10|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
209389|NCT01529645|O9|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209390|NCT01529645|O8|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209391|NCT01529645|O7|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209392|NCT01529645|O6|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209393|NCT01529645|O5|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209394|NCT01529645|O4|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209395|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
209396|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
209397|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
209398|NCT01529645|O10|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
209399|NCT01529645|O9|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209400|NCT01529645|O8|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209401|NCT01529645|O7|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209402|NCT01529645|O6|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209403|NCT01529645|O5|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209404|NCT01529645|O4|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209405|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
209406|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
209407|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
209408|NCT01529645|O4|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
209409|NCT01529645|O3|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209410|NCT01529645|O2|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
210489|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
209411|NCT01529645|O1|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209412|NCT01529645|O4|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day1 of this study.
209413|NCT01529645|O3|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209414|NCT01529645|O2|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209415|NCT01529645|O1|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209416|NCT01529645|O4|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day1 of this study.
209417|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
209418|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
209419|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
209420|NCT01529645|O10|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
209421|NCT01529645|O9|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209422|NCT01529645|O8|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209423|NCT01529645|O7|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209424|NCT01529645|O6|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209425|NCT01529645|O5|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209426|NCT01529645|O4|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209427|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
209428|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
209429|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
209430|NCT01529645|O10|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
209431|NCT01529645|O9|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209432|NCT01529645|O8|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209433|NCT01529645|O7|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209434|NCT01529645|O6|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209435|NCT01529645|O5|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209436|NCT01529645|O4|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209437|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
209438|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
209439|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
209440|NCT01529645|E10|Reported Event|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
209441|NCT01529645|E9|Reported Event|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
210490|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
209442|NCT01529645|E8|Reported Event|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209443|NCT01529645|E7|Reported Event|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209444|NCT01529645|E6|Reported Event|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209445|NCT01529645|E5|Reported Event|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209446|NCT01529645|E4|Reported Event|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
209447|NCT01529645|E3|Reported Event|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
209448|NCT01529645|E2|Reported Event|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
209449|NCT01529645|E1|Reported Event|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
209450|NCT01529632|B3|Baseline|Total|Total of all reporting groups
209451|NCT01529632|B2|Baseline|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
209452|NCT01529632|B1|Baseline|QVA149|QVA149 plus placebo once daily for 28 days.
209453|NCT01529632|P2|Participant Flow|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
209454|NCT01529632|P1|Participant Flow|QVA149|QVA149 plus placebo once daily for 28 days.
209455|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
209456|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
209457|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
209458|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
209459|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
209460|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
209461|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
209462|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
209463|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
209464|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
209465|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
209466|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
209467|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
209468|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
209469|NCT01529632|E2|Reported Event|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
209470|NCT01529632|E1|Reported Event|QVA149|QVA149 plus placebo once daily for 28 days.
209471|NCT01529515|B3|Baseline|Total|Total of all reporting groups
209472|NCT01529515|B2|Baseline|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
209473|NCT01529515|B1|Baseline|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
209474|NCT01529515|P4|Participant Flow|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
209475|NCT01529515|P3|Participant Flow|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
209476|NCT01529515|P2|Participant Flow|Open-Label Maintenance Phase: Paliperidone Palmitate 3-Month|Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 3.5-fold multiple of the PP1M dose received on Day 92 during the Transition Phase.
209477|NCT01529515|P1|Participant Flow|Open-Label Transition Phase: Paliperidone Palmitate 1-Month|Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 150 milligram equivalents (mg eq) on Day 1, 100 mg eq on Day 8, flexible dose (50, 75, 100, or 150 mg eq) on Day 36 and 64, and on Day 92 same dose as on Day 64.
209478|NCT01529515|O2|Outcome|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
209479|NCT01529515|O1|Outcome|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
209514|NCT01529450|P2|Participant Flow|Resistance Developed Group|"Patients previously treated with non-LDE225 Smo inhibitor who were initially responsive but became resistant with progressive disease.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
209480|NCT01529515|O2|Outcome|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
209481|NCT01529515|O1|Outcome|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
209482|NCT01529515|O2|Outcome|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
209483|NCT01529515|O1|Outcome|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
209484|NCT01529515|O2|Outcome|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
209485|NCT01529515|O1|Outcome|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
209486|NCT01529515|E3|Reported Event|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
209487|NCT01529515|E2|Reported Event|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
209488|NCT01529515|E1|Reported Event|Open-Label Phase: PP1M + PP3M|PP1M= Paliperidone Palmitate 1 Month and PP3M= Paliperidone Palmitate 3 Month. Open-Label Transition Phase: Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 150 milligram equivalents (mg eq) on Day 1, 100 mg eq on Day 8, flexible dose (50, 75, 100, or 150 mg eq) on Day 36 and 64, and on Day 92 same dose as on Day 64. Open-Label Maintenance Phase: Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 3.5-fold multiple of the PP1M dose received on Day 92 during the Transition Phase.
209489|NCT01529502|B7|Baseline|Total|Total of all reporting groups
209490|NCT01529502|B6|Baseline|Old Blood + Inhaled Nitric Oxide- Old Blood- Fresh Blood|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
209491|NCT01529502|B5|Baseline|Old Blood + Inhaled Nitric Oxide- Fresh Blood- Old Blood|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
209492|NCT01529502|B4|Baseline|Old Blood- Old Blood + Inhaled Nitric Oxide- Fresh Blood|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
209493|NCT01529502|B3|Baseline|Old Blood- Fresh Blood- Old Blood + Inhaled Nitric Oxide|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
209494|NCT01529502|B2|Baseline|Fresh Blood-Old Blood + Inhaled Nitric Oxide-Old Blood-|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
209515|NCT01529450|P1|Participant Flow|Refractory Group|"Patients previously treated with non-LDE225 Smo inhibitor who were refractory.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
209516|NCT01529450|O1|Outcome|All Participants|Participants received LDE225: 800-mg (4 200-mg capsules/day) capsule
209495|NCT01529502|B1|Baseline|Fresh Blood-Old Blood-Old Blood + Inhaled Nitric Oxide|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
209496|NCT01529502|P6|Participant Flow|Old Blood+iNO - Fresh Blood - Old Blood|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO)."
209497|NCT01529502|P5|Participant Flow|Old Blood - Old Blood+iNO - Fresh Blood|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO)."
209498|NCT01529502|P4|Participant Flow|Fresh Blood - Old Blood+iNO - Old Blood|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO)."
209499|NCT01529502|P3|Participant Flow|Old Blood+iNO - Old Blood - Fresh Blood|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO)."
209500|NCT01529502|P2|Participant Flow|Old Blood - Fresh Blood - Old Blood+iNO|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO)."
209501|NCT01529502|P1|Participant Flow|Fresh Blood - Old Blood - Old Blood+iNO|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO)."
209502|NCT01529502|O3|Outcome|Old Blood + Inhaled Nitric Oxide|"Red blood Cells auto-transfusion: Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
209503|NCT01529502|O2|Outcome|Old Blood|Red blood Cells auto-transfusion: Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
209504|NCT01529502|O1|Outcome|Fresh Blood|Red blood Cells auto-transfusion: Withdrawal from 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time. The same 14 subjects will be included in every arm of the study.
209505|NCT01529502|O3|Outcome|Old Blood + Inhaled Nitric Oxide|"Red blood Cells auto-transfusion: Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
209506|NCT01529502|O2|Outcome|Old Blood|Red blood Cells auto-transfusion: Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
209507|NCT01529502|O1|Outcome|Fresh Blood|Red blood Cells auto-transfusion: Withdrawal from 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time. The same 14 subjects will be included in every arm of the study.
209508|NCT01529502|E3|Reported Event|Old Blood + Inhaled Nitric Oxide|"Red blood Cells auto-transfusion: Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
209509|NCT01529502|E2|Reported Event|Old Blood|Red blood Cells auto-transfusion: Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
209510|NCT01529502|E1|Reported Event|Fresh Blood|Red blood Cells auto-transfusion: Withdrawal from 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time. The same 14 subjects will be included in every arm of the study.
209511|NCT01529450|B3|Baseline|Total|Total of all reporting groups
209512|NCT01529450|B2|Baseline|Resistance Developed Group|"Patients previously treated with non-LDE225 Smo inhibitor who were initially responsive but became resistant with progressive disease.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
210491|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
209517|NCT01529450|O2|Outcome|Resistance Developed Group|"Patients previously treated with non-LDE225 Smo inhibitor who were initially responsive but became resistant with progressive disease.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
209518|NCT01529450|O1|Outcome|Refractory Group|"Patients previously treated with non-LDE225 Smo inhibitor who were refractory.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
209519|NCT01529450|E2|Reported Event|Resistance Developed Group|"Patients previously treated with non-LDE225 Smo inhibitor who were initially responsive but became resistant with progressive disease.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
209520|NCT01529450|E1|Reported Event|Refractory Group|"Patients previously treated with non-LDE225 Smo inhibitor who were refractory.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
209521|NCT01529385|B3|Baseline|Total|Total of all reporting groups
209522|NCT01529385|B2|Baseline|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
209523|NCT01529385|B1|Baseline|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
209524|NCT01529385|P2|Participant Flow|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
209525|NCT01529385|P1|Participant Flow|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
209526|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
209527|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
209528|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
209529|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
209530|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
209531|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
209532|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
209533|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
209534|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
209535|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
209536|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
209537|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
209538|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
209539|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
209540|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
209541|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
209542|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
209543|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
209843|NCT01528592|P1|Participant Flow|On / Off Medication|Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
209544|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
209545|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
209546|NCT01529385|E2|Reported Event|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
209547|NCT01529385|E1|Reported Event|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
209548|NCT01529268|B3|Baseline|Total|Total of all reporting groups
209549|NCT01529268|B2|Baseline|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209550|NCT01529268|B1|Baseline|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209551|NCT01529268|P2|Participant Flow|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209552|NCT01529268|P1|Participant Flow|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209553|NCT01529268|O2|Outcome|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209554|NCT01529268|O1|Outcome|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209555|NCT01529268|O2|Outcome|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209556|NCT01529268|O1|Outcome|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209557|NCT01529268|O2|Outcome|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209558|NCT01529268|O1|Outcome|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209559|NCT01529268|O2|Outcome|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209560|NCT01529268|O1|Outcome|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209561|NCT01529268|O2|Outcome|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209562|NCT01529268|O1|Outcome|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209563|NCT01529268|O2|Outcome|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209564|NCT01529268|O1|Outcome|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209844|NCT01528592|O1|Outcome|On / Off Medication|Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
209565|NCT01529268|O2|Outcome|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209566|NCT01529268|O1|Outcome|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209567|NCT01529268|O2|Outcome|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209568|NCT01529268|O1|Outcome|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209569|NCT01529268|O2|Outcome|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209570|NCT01529268|O1|Outcome|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209571|NCT01529268|O2|Outcome|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209572|NCT01529268|O1|Outcome|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209573|NCT01529268|O2|Outcome|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209574|NCT01529268|O1|Outcome|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209575|NCT01529268|O2|Outcome|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209576|NCT01529268|O1|Outcome|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209577|NCT01529268|O2|Outcome|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209578|NCT01529268|O1|Outcome|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209579|NCT01529268|O2|Outcome|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209580|NCT01529268|O1|Outcome|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209581|NCT01529268|O2|Outcome|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209582|NCT01529268|O1|Outcome|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209583|NCT01529268|O2|Outcome|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209637|NCT01529112|E2|Reported Event|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
210492|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
209584|NCT01529268|O1|Outcome|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209585|NCT01529268|O2|Outcome|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209586|NCT01529268|O1|Outcome|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209587|NCT01529268|O2|Outcome|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209588|NCT01529268|O1|Outcome|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209589|NCT01529268|O2|Outcome|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209590|NCT01529268|O1|Outcome|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209591|NCT01529268|O2|Outcome|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209592|NCT01529268|O1|Outcome|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209593|NCT01529268|O2|Outcome|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209594|NCT01529268|O1|Outcome|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209595|NCT01529268|O2|Outcome|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209596|NCT01529268|O1|Outcome|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209597|NCT01529268|O2|Outcome|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209598|NCT01529268|O1|Outcome|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209599|NCT01529268|O2|Outcome|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209600|NCT01529268|O1|Outcome|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209601|NCT01529268|O2|Outcome|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209602|NCT01529268|O1|Outcome|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209638|NCT01529112|E1|Reported Event|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
209639|NCT01528969|B3|Baseline|Total|Total of all reporting groups
209603|NCT01529268|E2|Reported Event|DR Cysteamine Bitartrate Placebo|"Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209604|NCT01529268|E1|Reported Event|DR Cysteamine Bitartrate Capsule|"Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
209605|NCT01529203|B1|Baseline|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane~Botulinum Toxin Type A (Azzalure): Powder for solution for injection~Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
209606|NCT01529203|P1|Participant Flow|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane~Botulinum Toxin Type A (Azzalure): Powder for solution for injection~Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
209607|NCT01529203|O1|Outcome|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane~Botulinum Toxin Type A (Azzalure): Powder for solution for injection~Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
209608|NCT01529203|O1|Outcome|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane~Botulinum Toxin Type A (Azzalure): Powder for solution for injection~Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
209609|NCT01529203|O1|Outcome|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane~Botulinum Toxin Type A (Azzalure): Powder for solution for injection~Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
209610|NCT01529203|E1|Reported Event|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane~Botulinum Toxin Type A (Azzalure): Powder for solution for injection~Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
209611|NCT01529112|B3|Baseline|Total|Total of all reporting groups
209612|NCT01529112|B2|Baseline|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
209613|NCT01529112|B1|Baseline|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
209614|NCT01529112|P2|Participant Flow|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
209615|NCT01529112|P1|Participant Flow|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
209616|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
209617|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
209618|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
209619|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
209620|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
209621|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
209622|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
209623|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
209624|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
209625|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
209626|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
209627|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
209628|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
209629|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
209630|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
209631|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
209632|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
209633|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
209634|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
209635|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
209636|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
210493|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
209640|NCT01528969|B2|Baseline|Sorbitol|"A half of the subjects (n = 38) were randomly allocated into sorbitol group.~Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks. Each chewing gum pellet contained sorbitol 63% and sorbitol 2%."
209641|NCT01528969|B1|Baseline|Xylitol|"A half of the subjects (n = 37) were randomly allocated into xylitol group.~Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks. Each chewing gum pellet contained 65% xylitol w/w."
209642|NCT01528969|P2|Participant Flow|Sorbitol|"A half of the subjects (n = 38) were randomly allocated into sorbitol group.~Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks."
209643|NCT01528969|P1|Participant Flow|Xylitol|"A half of the subjects (n = 37) were randomly allocated into xylitol group.~Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks."
209644|NCT01528969|O2|Outcome|Sorbitol|"A half of the subjects (n = 38) were randomly allocated into sorbitol group.~Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks. Each chewing gum pellet contained sorbitol 63% and sorbitol 2%."
209645|NCT01528969|O1|Outcome|Xylitol|"A half of the subjects (n = 37) were randomly allocated into xylitol group.~Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks. Each chewing gum pellet contained 65% xylitol w/w."
209646|NCT01528969|E2|Reported Event|Sorbitol|"A half of the subjects (n = 38) were randomly allocated into sorbitol group.~Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks. Each chewing gum pellet contained sorbitol 63% and sorbitol 2%.~None of the subjects had any adverse effects of the consumption of the chewing gum."
209647|NCT01528969|E1|Reported Event|Xylitol|"A half of the subjects (n = 37) were randomly allocated into xylitol group.~Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks. Each chewing gum pellet contained 65% xylitol w/w.~None of the subjects had any adverse effects of the consumption of the chewing gum."
209648|NCT01528891|B3|Baseline|Total|Total of all reporting groups
209649|NCT01528891|B2|Baseline|Placebo|"Normal saline equivalent volume~Placebo~Of the 200 patients in this treatment arm, 2 were totally excluded from analysis due to administration of medications that were not a part of the anesthetic protocol."
209650|NCT01528891|B1|Baseline|Dexmedetomidine|"Dexmedetomidine~Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery~Of the 200 patients in this treatment arm, 5 were totally excluded from analysis due to administration of medications that were not a part of the anesthetic protocol."
209651|NCT01528891|P2|Participant Flow|Placebo|"Normal saline equivalent volume~Placebo"
209652|NCT01528891|P1|Participant Flow|Dexmedetomidine|"Dexmedetomidine~Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery"
209653|NCT01528891|O2|Outcome|Placebo|"Normal saline equivalent volume~Placebo"
209654|NCT01528891|O1|Outcome|Dexmedetomidine|"Dexmedetomidine~Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery"
209655|NCT01528891|O2|Outcome|Placebo|"Normal saline equivalent volume~Placebo"
209656|NCT01528891|O1|Outcome|Dexmedetomidine|"Dexmedetomidine~Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery"
209657|NCT01528891|O2|Outcome|Placebo|"Normal saline equivalent volume~Placebo"
209658|NCT01528891|O1|Outcome|Dexmedetomidine|"Dexmedetomidine~Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery"
209659|NCT01528891|O2|Outcome|Placebo|"Normal saline~Placebo"
209660|NCT01528891|O1|Outcome|Dexmedetomidine|"Dexmedetomidine~Dexmedetomidine: 0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery"
209661|NCT01528891|E2|Reported Event|Placebo|"Normal saline equivalent volume~Placebo"
209662|NCT01528891|E1|Reported Event|Dexmedetomidine|"Dexmedetomidine~Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery"
209663|NCT01528878|B1|Baseline|Single Arm Patients With HCC or Liver Metastases|Patients with hepatocellular carcinoma (HCC) who are not appropriate for surgical resection or radiofrequency ablation (RFA) as a bridge to transplant, or with positive margins after surgical resection, with no cirrhosis, or Child-Pugh A or B. In addition, patients with limited liver metastases (≤3) from colon or rectal cancer or other cancers for whom local therapy to the liver is deemed appropriate, but who are not amenable for curative therapy with surgical resection or radio frequency ablation would also be eligible.
209664|NCT01528878|P1|Participant Flow|Single Arm Patients With HCC or Liver Metastases|Patients with hepatocellular carcinoma (HCC) who are not appropriate for surgical resection or radiofrequency ablation (RFA) as a bridge to transplant, or with positive margins after surgical resection, with no cirrhosis, or Child-Pugh A or B. In addition, patients with limited liver metastases (≤3) from colon or rectal cancer or other cancers for whom local therapy to the liver is deemed appropriate, but who are not amenable for curative therapy with surgical resection or radio frequency ablation would also be eligible.
209665|NCT01528878|O2|Outcome|Patients With Liver Metastases|Patients with liver metastatic cancer including; colorectal, breast, and other.
209666|NCT01528878|O1|Outcome|Patients With Primary HCC|Patients with diagnosed with primary hepatocellular carcinoma
209667|NCT01528878|O2|Outcome|Patients With Liver Metastases|Patients with liver metastatic cancer including; colorectal, breast, and other.
209668|NCT01528878|O1|Outcome|Patients With Primary HCC|Patients with diagnosed with primary hepatocellular carcinoma
209669|NCT01528878|O2|Outcome|Patients With Liver Metastases|Patients with liver metastatic cancer including; colorectal, breast, and other.
209670|NCT01528878|O1|Outcome|Patients With Primary HCC|Patients with diagnosed with primary hepatocellular carcinoma
209671|NCT01528878|O2|Outcome|Grade 3 Adverse Events|Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.
209672|NCT01528878|O1|Outcome|Grade 2 Adverse Events|Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL)
209827|NCT01528605|O3|Outcome|High Lutein|"high lutein group~high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
209828|NCT01528605|O2|Outcome|Low Lutein|"low lutein group~low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
209673|NCT01528878|E1|Reported Event|Single Arm Patients With HCC or Liver Metastases|Patients with hepatocellular carcinoma (HCC) who are not appropriate for surgical resection or radiofrequency ablation (RFA) as a bridge to transplant, or with positive margins after surgical resection, with no cirrhosis, or Child-Pugh A or B. In addition, patients with limited liver metastases (≤3) from colon or rectal cancer or other cancers for whom local therapy to the liver is deemed appropriate, but who are not amenable for curative therapy with surgical resection or radio frequency ablation would also be eligible.
209674|NCT01528787|B5|Baseline|Total|Total of all reporting groups
209675|NCT01528787|B4|Baseline|AR-13324 Ophthalmic Solution Vehicle|1 drop to study eye once daily (QD) in the morning (AM)
209676|NCT01528787|B3|Baseline|AR-13324 Ophthalmic Solution 0.04%|1 drop to study eye once daily (QD) in the morning (AM)
209677|NCT01528787|B2|Baseline|AR-13324 Ophthalmic Solution 0.02%|1 drop to study eye once daily (QD) in the morning (AM)
209678|NCT01528787|B1|Baseline|AR-13324 Ophthalmic Solution 0.01%|1 drop to study eye once daily (QD) in the morning (AM)
209679|NCT01528787|P4|Participant Flow|AR-13324 Opththalmic Solution Vehicle|1 drop to study eye once daily (QD) in the morning (AM)
209680|NCT01528787|P3|Participant Flow|AR-13324 Ophthalmic Solution 0.04%|1 drop to study eye once daily (QD) in the morning (AM)
209681|NCT01528787|P2|Participant Flow|AR-13324 Ophthalmic Solution 0.02%|1 drop to study eye once daily (QD) in the morning (AM)
209682|NCT01528787|P1|Participant Flow|AR-13324 Ophthalmic Solution 0.01%|1 drop to study eye once daily (QD) in the morning (AM)
209683|NCT01528787|O4|Outcome|AR-13324 Ophthalmic Solution Vehicle|1 drop to study eye once daily (QD) in the morning (AM)
209684|NCT01528787|O3|Outcome|AR-13324 Ophthalmic Solution 0.04%|1 drop to study eye once daily (QD) in the morning (AM)
209685|NCT01528787|O2|Outcome|AR-13324 Ophthalmic Solution 0.02%|1 drop to study eye once daily (QD) in the morning (AM)
209686|NCT01528787|O1|Outcome|AR-13324 Ophthalmic Solution 0.01%|1 drop to study eye once daily (QD) in the morning (AM)
209687|NCT01528787|E4|Reported Event|AR-13324 Ophthalmic Solution Vehicle|1 drop to study eye once daily (QD) in the morning (AM)
209688|NCT01528787|E3|Reported Event|AR-13324 Ophthalmic Solution 0.04%|1 drop to study eye once daily (QD) in the morning (AM)
209689|NCT01528787|E2|Reported Event|AR-13324 Ophthalmic Solution 0.02%|1 drop to study eye once daily (QD) in the morning (AM)
209690|NCT01528787|E1|Reported Event|AR-13324 Ophthalmic Solution 0.01%|1 drop to study eye once daily (QD) in the morning (AM)
209691|NCT01528735|B3|Baseline|Total|Total of all reporting groups
209692|NCT01528735|B2|Baseline|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209693|NCT01528735|B1|Baseline|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209694|NCT01528735|P2|Participant Flow|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209695|NCT01528735|P1|Participant Flow|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209696|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209697|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209698|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209699|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209700|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209701|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209702|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209703|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209704|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209705|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209706|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209707|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209708|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209709|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209710|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209711|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209712|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209713|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209714|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209715|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209716|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209717|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209829|NCT01528605|O1|Outcome|Placebo|"starch in hard shell gelatine capsules~placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
209830|NCT01528605|O6|Outcome|High Lutein Zeaxanthin|"Zeaxanthin plus lutein group~zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks"
209718|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209719|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209720|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209721|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209722|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209723|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209724|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209725|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209726|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209727|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209728|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209729|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209730|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209731|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209732|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209733|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209831|NCT01528605|O5|Outcome|High Zeaxanthin|"zeaxanthin group~high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks"
209832|NCT01528605|O4|Outcome|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group~lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
209734|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209735|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209736|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209737|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209738|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209739|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209740|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209741|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209742|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209743|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209744|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209745|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209746|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209747|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209748|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209749|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209833|NCT01528605|O3|Outcome|High Lutein|"high lutein group~high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
209834|NCT01528605|O2|Outcome|Low Lutein|"low lutein group~low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
209750|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209751|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209752|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209753|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209754|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209755|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209756|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209757|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209758|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209759|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209760|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209761|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209762|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209763|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209764|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209765|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209835|NCT01528605|O1|Outcome|Placebo|"starch in hard shell gelatine capsules~placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
209836|NCT01528605|E6|Reported Event|High Lutein Zeaxanthin|"Zeaxanthin plus lutein group~zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks"
209766|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209767|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209768|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209769|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209770|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209771|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209772|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209773|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209774|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209775|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209776|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209777|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209778|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209779|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209780|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209781|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209837|NCT01528605|E5|Reported Event|High Zeaxanthin|"zeaxanthin group~high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks"
209838|NCT01528605|E4|Reported Event|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group~lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
209782|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209783|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209784|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209785|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209786|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209787|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209788|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209789|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
209790|NCT01528735|E4|Reported Event|Faldap/pegIFN/RBV:120mg Faldap and 600mg Del.|Patients received 24 weeks 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV), following treatment of 8 weeks of 600mg twice daily (bid.) deleobuvir (del) and 120 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV).
209791|NCT01528735|E3|Reported Event|Faldap/pegIFN/RBV:80mg Faldap and 600mg Del.|Patients received 24 weeks 120 mg once daily (qd) faldaprevir (faldap) in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV), following treatment of 8 weeks of 600mg twice daily (bid) deleobuvir (del) and 80 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV).
209792|NCT01528735|E2|Reported Event|Faldap/Del/RBV:120mg Faldap and 600mg Del.|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir (del) and 120 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV)
209793|NCT01528735|E1|Reported Event|Faldap/Del/RBV:80mg Faldap and 600mg Del.|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir (del) and 80 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV)
209794|NCT01528696|B3|Baseline|Total|Total of all reporting groups
209795|NCT01528696|B2|Baseline|Silverlon|"Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing~Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.~All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum."
209796|NCT01528696|B1|Baseline|Standard Dressing|"Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing~Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse."
209797|NCT01528696|P2|Participant Flow|Silverlon|"Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing~Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.~All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum."
209798|NCT01528696|P1|Participant Flow|Standard Dressing|"Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing~Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse."
209839|NCT01528605|E3|Reported Event|High Lutein|"high lutein group~high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
209840|NCT01528605|E2|Reported Event|Low Lutein|"low lutein group~low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
209799|NCT01528696|O2|Outcome|Silverlon|"Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing~Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.~All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum."
209800|NCT01528696|O1|Outcome|Standard Dressing|"Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing~Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse."
209801|NCT01528696|O2|Outcome|Silverlon|"Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing~Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.~All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum."
209802|NCT01528696|O1|Outcome|Standard Dressing|"Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing~Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse."
209803|NCT01528696|O2|Outcome|Silverlon|"Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing~Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.~All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum."
209804|NCT01528696|O1|Outcome|Standard Dressing|"Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing~Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse."
209805|NCT01528696|E2|Reported Event|Silverlon|"Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing~Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.~All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum."
209806|NCT01528696|E1|Reported Event|Standard Dressing|"Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing~Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse."
209807|NCT01528605|B7|Baseline|Total|Total of all reporting groups
209808|NCT01528605|B6|Baseline|High Lutein Zeaxanthin|"Zeaxanthin plus lutein group~zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks"
209809|NCT01528605|B5|Baseline|High Zeaxanthin|"zeaxanthin group~high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks"
209810|NCT01528605|B4|Baseline|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group~lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
209811|NCT01528605|B3|Baseline|High Lutein|"high lutein group~high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
209812|NCT01528605|B2|Baseline|Placebo|"starch in hard shell gelatine capsules~placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
209813|NCT01528605|B1|Baseline|Low Lutein|"low lutein group~low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
209814|NCT01528605|P6|Participant Flow|High Lutein Zeaxanthin|"Zeaxanthin plus lutein group~zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks"
209815|NCT01528605|P5|Participant Flow|High Zeaxanthin|"zeaxanthin group~high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks"
209816|NCT01528605|P4|Participant Flow|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group~lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
209817|NCT01528605|P3|Participant Flow|High Lutein|"high lutein group~high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
209818|NCT01528605|P2|Participant Flow|Placebo|"starch in hard shell gelatine capsules~placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
209819|NCT01528605|P1|Participant Flow|Low Lutein|"low lutein group~low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
209820|NCT01528605|O6|Outcome|High Lutein Zeaxanthin|"Zeaxanthin plus lutein group~zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks"
209821|NCT01528605|O5|Outcome|High Zeaxanthin|"zeaxanthin group~high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks"
209822|NCT01528605|O4|Outcome|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group~lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
209823|NCT01528605|O3|Outcome|High Lutein|"high lutein group~high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
209824|NCT01528605|O2|Outcome|Low Lutein|"low lutein group~low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
209825|NCT01528605|O1|Outcome|Placebo|"starch in hard shell gelatine capsules~placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
209826|NCT01528605|O4|Outcome|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group~lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
209845|NCT01528592|E1|Reported Event|On / Off Medication|Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
209846|NCT01528345|B3|Baseline|Total|Total of all reporting groups
209847|NCT01528345|B2|Baseline|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
209848|NCT01528345|B1|Baseline|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
209849|NCT01528345|P2|Participant Flow|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
209850|NCT01528345|P1|Participant Flow|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
209851|NCT01528345|O2|Outcome|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
209852|NCT01528345|O1|Outcome|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
209853|NCT01528345|O2|Outcome|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
209854|NCT01528345|O1|Outcome|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
209855|NCT01528345|O2|Outcome|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
209856|NCT01528345|O1|Outcome|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
209857|NCT01528345|O2|Outcome|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
209858|NCT01528345|O1|Outcome|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
209859|NCT01528345|O2|Outcome|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
209860|NCT01528345|O1|Outcome|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
209861|NCT01528345|O2|Outcome|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
209862|NCT01528345|O1|Outcome|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
209863|NCT01528345|E2|Reported Event|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
209864|NCT01528345|E1|Reported Event|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
209865|NCT01528332|B3|Baseline|Total|Total of all reporting groups
209866|NCT01528332|B2|Baseline|Control PRP Device|Control PRP device: Light wavelength 531 ± 7 nm, maximum 0.4 ± 0.1 mW/cm² and average 0.2 ± 0.05 mW/cm², light on for 5 seconds, device worn for 30 minutes
209867|NCT01528332|B1|Baseline|Pain Relief Patch|Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes
209868|NCT01528332|P2|Participant Flow|Control PRP Device|Control PRP device: Light wavelength 531 ± 7 nm, maximum 0.4 ± 0.1 mW/cm² and average 0.2 ± 0.05 mW/cm², light on for 5 seconds, device worn for 30 minutes
209869|NCT01528332|P1|Participant Flow|Pain Relief Patch|Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes
209870|NCT01528332|O2|Outcome|Control PRP Device|Control PRP device: Light wavelength 531 ± 7 nm, maximum 0.4 ± 0.1 mW/cm² and average 0.2 ± 0.05 mW/cm², light on for 5 seconds, device worn for 30 minutes
209871|NCT01528332|O1|Outcome|Pain Relief Patch|Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes
209872|NCT01528332|E2|Reported Event|Control PRP Device|Control PRP device: Light wavelength 531 ± 7 nm, maximum 0.4 ± 0.1 mW/cm² and average 0.2 ± 0.05 mW/cm², light on for 5 seconds, device worn for 30 minutes
209873|NCT01528332|E1|Reported Event|Pain Relief Patch|Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes
209874|NCT01528319|B1|Baseline|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
209875|NCT01528319|P1|Participant Flow|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
209876|NCT01528319|O1|Outcome|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
209877|NCT01528319|O1|Outcome|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
209878|NCT01528319|O1|Outcome|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
209879|NCT01528319|O1|Outcome|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
209880|NCT01528319|O1|Outcome|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
209881|NCT01528319|O1|Outcome|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
209882|NCT01528319|E1|Reported Event|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
209883|NCT01528293|B3|Baseline|Total|Total of all reporting groups
209884|NCT01528293|B2|Baseline|Compression Therapy Only|"Standard of Care compression therapy only~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
209915|NCT01527942|P1|Participant Flow|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
209916|NCT01527942|O2|Outcome|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
209917|NCT01527942|O1|Outcome|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
209885|NCT01528293|B1|Baseline|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
209886|NCT01528293|P2|Participant Flow|Compression Therapy Only|"Standard of Care compression therapy only~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
209887|NCT01528293|P1|Participant Flow|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
209888|NCT01528293|O2|Outcome|Compression Therapy Only|"Standard of Care compression therapy only~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
209889|NCT01528293|O1|Outcome|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
209890|NCT01528293|O2|Outcome|Compression Therapy Only|"Standard of Care compression therapy only~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
209891|NCT01528293|O1|Outcome|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
209892|NCT01528293|O2|Outcome|Compression Therapy Only|"Standard of Care compression therapy only~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
210494|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
209893|NCT01528293|O1|Outcome|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
209894|NCT01528293|O2|Outcome|Compression Therapy Only|"Standard of Care compression therapy only~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
209895|NCT01528293|O1|Outcome|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
209896|NCT01528293|E2|Reported Event|Compression Therapy Only|"Standard of Care compression therapy only~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
209897|NCT01528293|E1|Reported Event|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
209898|NCT01528215|B3|Baseline|Total|Total of all reporting groups
209899|NCT01528215|B2|Baseline|OsseoSpeed TX|OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
209900|NCT01528215|B1|Baseline|OsseoSpeed EV|OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
209901|NCT01528215|P2|Participant Flow|OsseoSpeed TX|OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
209902|NCT01528215|P1|Participant Flow|OsseoSpeed EV|OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
209903|NCT01528215|O2|Outcome|OsseoSpeed TX|OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
209904|NCT01528215|O1|Outcome|OsseoSpeed EV|OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
209905|NCT01528215|E2|Reported Event|OsseoSpeed TX|OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
209906|NCT01528215|E1|Reported Event|OsseoSpeed EV|OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
209907|NCT01528150|B1|Baseline|Accent MRI System|Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
209908|NCT01528150|P1|Participant Flow|Accent MRI System|Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
209909|NCT01528150|O1|Outcome|Accent MRI System|Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
209910|NCT01528150|E1|Reported Event|Accent MRI System|Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
209911|NCT01527942|B3|Baseline|Total|Total of all reporting groups
209912|NCT01527942|B2|Baseline|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
209913|NCT01527942|B1|Baseline|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
209914|NCT01527942|P2|Participant Flow|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
210495|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
209918|NCT01527942|O2|Outcome|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
209919|NCT01527942|O1|Outcome|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
209920|NCT01527942|O2|Outcome|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
209921|NCT01527942|O1|Outcome|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
209922|NCT01527942|E2|Reported Event|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
209923|NCT01527942|E1|Reported Event|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
209924|NCT01527513|B3|Baseline|Total|Total of all reporting groups
209925|NCT01527513|B2|Baseline|Placebo|Placebo QD
209926|NCT01527513|B1|Baseline|Esl (BIA 2-093)|Eslicarbazepine acetate (BIA 2-093): ESL 30 mg/kg/day QD (maximum 1200 mg/day).
209927|NCT01527513|P2|Participant Flow|Esl (BIA 2-093)|Eslicarbazepine acetate (BIA 2-093): ESL 10-30 mg/kg/day QD (maximum 1200 mg/day).
209928|NCT01527513|P1|Participant Flow|Placebo|Placebo Once-Daily (QD)
209929|NCT01527513|O1|Outcome|Esl PART II|Eslicarbazepine acetate (ESL) 10-30 mg/kg/day QD (maximum 1200 mg/day).
209930|NCT01527513|O2|Outcome|Esl (BIA 2-093)|Eslicarbazepine acetate (BIA 2-093): ESL 30 mg/kg/day QD (maximum 1200 mg/day).
209931|NCT01527513|O1|Outcome|Placebo|Placebo QD
209932|NCT01527513|O2|Outcome|Esl (BIA 2-093)|Eslicarbazepine acetate (BIA 2-093): ESL 30 mg/kg/day QD (maximum 1200 mg/day).
209933|NCT01527513|O1|Outcome|Placebo|Placebo QD
209934|NCT01527513|E3|Reported Event|Part II - ESL|Eslicarbazepine acetate (ESL) - 30 mg/kg/day QD maximum 1200 mg/day.
209935|NCT01527513|E2|Reported Event|Part I - ESL|Eslicarbazepine acetate (ESL) - 30 mg/kg/day QD maximum 1200 mg/day.
209936|NCT01527513|E1|Reported Event|Placebo|Placebo QD
209937|NCT01527487|B3|Baseline|Total|Total of all reporting groups
209938|NCT01527487|B2|Baseline|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m2 IV (Day 1), given by 1-hour IV infusion;~Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard"
209939|NCT01527487|B1|Baseline|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m2 IV (Days 1 and 8) given short (≤1.5 minutes) IV infusion, per institutional standard;~Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard"
209940|NCT01527487|P2|Participant Flow|Docetaxel+Cyclophosphamide: TC|"Docetaxel (T): 75 mg/m^2 by IV infusion (Day 1); Cyclophosphamide (C): 600 mg/m^2 by IV infusion (Day 1)tandard.~Administered every 21 days for 6 cycles followed by surgery."
209941|NCT01527487|P1|Participant Flow|Eribulin+Cyclophosphamide: ErC|"Eribulin (Er): 1.4 mg/m^2 by IV infusion (Days 1 and 8); Cyclophosphamide (C): 600 mg/m^2 by IV infusion (Day 1)~Administered every 21 days for 6 cycles followed by surgery."
209942|NCT01527487|O2|Outcome|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m2 IV (Day 1), given by 1-hour IV infusion~Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard~Cyclophosphamide: Cyclophosphamide will be given as an IV infusion (600 mg/m2) on Day 1 of each treatment cycle over approximately 30 minutes, or per institutional standard.~Docetaxel: Patients assigned to Treatment Arm 2 will receive docetaxel 75 mg/m2 IV on Day 1 of each treatment cycle every 3 weeks."
209943|NCT01527487|O1|Outcome|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m^2 IV (Days 1 and 8 of each treatment cycle) by IV infusion.~Cyclophosphamide (C): 600 mg/m^2 IV (Day 1 of each treatment cycle by IV infusion."
209944|NCT01527487|O2|Outcome|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m^2 (Day 1 of each treatment cycle) by IV infusion.~Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle) by IV infusion."
209945|NCT01527487|O1|Outcome|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m^2 (Days 1 and 8 of each treatment cycle) by IV infusion.~Cyclophosphamide (C): 600 mg/m^2 IV (Day 1 of each treatment cycle) by IV infusion."
209946|NCT01527487|O2|Outcome|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m^2 (Day 1 of each treatment cycle) by IV infusion.~Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle) by IV infusion."
209947|NCT01527487|O1|Outcome|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m^2 (Days 1 and 8 of each treatment cycle) by IV infusion.~Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle) by IV infusion."
209948|NCT01527487|O2|Outcome|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m^2 (Day 1 of each treatment cycle), by IV infusion~Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle)"
209949|NCT01527487|O1|Outcome|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m^2 (Days 1 and 8 of each treatment cycle) by IV infusion~Cyclophosphamide (C): 600 mg/m^2 IV (Day 1 of each treatment cycle) by IV infusion"
209950|NCT01527487|E2|Reported Event|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m2 IV (Day 1), given by 1-hour IV infusion~Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard~Cyclophosphamide: Cyclophosphamide will be given as an IV infusion (600 mg/m2) on Day 1 of each treatment cycle over approximately 30 minutes, or per institutional standard.~Docetaxel: Patients assigned to Treatment Arm 2 will receive docetaxel 75 mg/m2 IV on Day 1 of each treatment cycle every 3 weeks."
209951|NCT01527487|E1|Reported Event|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m2 IV (Days 1 and 8) given short (≤1.5 minutes) IV infusion, per institutional standard~Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard~Eribulin: 1.4 mg/m2 IV (Days 1 & 8), given short (≤15 minute) IV infusion, per institutional standard~Cyclophosphamide: Cyclophosphamide will be given as an IV infusion (600 mg/m2) on Day 1 of each treatment cycle over approximately 30 minutes, or per institutional standard."
209952|NCT01527370|B1|Baseline|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
209953|NCT01527370|P1|Participant Flow|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
209954|NCT01527370|O1|Outcome|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
209955|NCT01527370|O1|Outcome|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
209956|NCT01527370|O1|Outcome|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
209957|NCT01527370|E1|Reported Event|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
209958|NCT01527162|B1|Baseline|All Participants|We used a randomized cross-over design with eleven children with bilateral 9 CP, mean age 4.3 years. Subjects were randomized to their current SAFO worn or SAFO not worn for 2 weeks and then crossed over.
209959|NCT01527162|P2|Participant Flow|SAFO NOT Worn First, Then Worn|Child does not wear their prescirbed SAFO for 14 days by random assignment, then worn
209960|NCT01527162|P1|Participant Flow|SAFO Worn First, Then Not Worn|Child wears their prescribed SAFO for 14 days by random assignment and then not worn
209961|NCT01527162|O2|Outcome|SAFO Not Worn|Child does not wears their prescribed SAFO for 14 days
209962|NCT01527162|O1|Outcome|SAFO Worn|Child wears their prescribed SAFO for 14 days
209963|NCT01527162|O2|Outcome|SAFO Not Worn|Child does not wear the prescribed SAFO for 14 days
209964|NCT01527162|O1|Outcome|SAFO Worn|Child wears their prescribed SAFO for 14 days
209965|NCT01527162|O2|Outcome|SAFO Not Worn|Child does not wear the prescribed SAFO for 14 days
209966|NCT01527162|O1|Outcome|SAFO Worn|"Child wears their prescribed SAFO for 14 days~SAFO worn: Child wears their prescribed SAFO for 14 days by random assignment~SAFO not worn: Child does not wear their prescirbed SAFO for 14 days by random assignment"
209967|NCT01527162|E2|Reported Event|SAFO Not Worn|SAFO not worn: Child does ont wear their prescribed SAFO for 14 days by random assignment
209968|NCT01527162|E1|Reported Event|SAFO Worn|SAFO worn: Child wears their prescirbed SAFO for 14 dyas by random assignment
209969|NCT01527110|B1|Baseline|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
209970|NCT01527110|P1|Participant Flow|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kilogram (kg) with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 minutes (min) for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated creatinine clearance (CLcr) with the initial dose corresponding to a CLcr of > =80 milliliter per min (mL/min) for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
209971|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
209972|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
210025|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
210496|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
209973|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
209974|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
209975|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
209976|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
209977|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
209978|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
209979|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
209980|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
210087|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
209981|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
209982|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
209983|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
209984|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
209985|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
209986|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
209987|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
209988|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
210088|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
209989|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
209990|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
209991|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
209992|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
209993|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
209994|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
209995|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
209996|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
210089|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
209997|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
209998|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
209999|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
210000|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
210001|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
210002|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
210003|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
210004|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
210090|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
210005|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
210006|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
210007|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
210008|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
210009|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
210010|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
210011|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
210012|NCT01527110|O1|Outcome|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
210091|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
210013|NCT01527110|E1|Reported Event|Zanamivir 600 mg BID|Eligible participants >=18 years and adolescents >=50 kg with normal renal function were administered an initial dose of IV zanamivir is 600 mg followed by BID maintenance dose administered at a constant rate over approximately 30 min for 5 days. The standard dosage for adolescent participants <50 kg was 12 mg/kg. The BID maintenance dose regimen began 12 hours after starting the initial dose infusion. Participants with renal impairment received an adjusted dose based on calculated CLcr with the initial dose corresponding to a CLcr of > =80 mL/min for adults and for adolescent participants > = 50 kg (i.e. 600 mg) or to the appropriate weight-based dose corresponding to a CLcr > = 80 mL/min for adolescent participants <50 kg (i.e. 12 mg/kg). There was a delay of 24 to 48 hours after the initial dose before the BID maintenance dose regimen was initiated for participants with severe renal impairment.
210014|NCT01527006|B3|Baseline|Total|Total of all reporting groups
210015|NCT01527006|B2|Baseline|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210016|NCT01527006|B1|Baseline|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210017|NCT01527006|P2|Participant Flow|Cohort ( ≥ 7 to < 12 Years of Age)|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
210018|NCT01527006|P1|Participant Flow|Cohort ( ≥ 2 to < 7 Years of Age)|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
210019|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
210020|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
210021|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
210022|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
210023|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
210024|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
210026|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
210027|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210028|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210029|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210030|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210031|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210032|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210033|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210034|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210035|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210036|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210037|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210038|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210039|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210040|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210041|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210092|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
210497|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
210042|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210043|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210044|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210045|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210046|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210047|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210048|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210049|NCT01527006|O4|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
210050|NCT01527006|O3|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
210051|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210052|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210053|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210054|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210055|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210056|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210057|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210058|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210093|NCT01526785|E1|Reported Event|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per participant's routine practice.
210059|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210060|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210061|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210062|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210063|NCT01527006|E4|Reported Event|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
210064|NCT01527006|E3|Reported Event|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
210065|NCT01527006|E2|Reported Event|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210066|NCT01527006|E1|Reported Event|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
210067|NCT01526902|B1|Baseline|Overall Study Population|Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.
210068|NCT01526902|P2|Participant Flow|Lotrafilcon B (AIR OPTIX MF) / Omafilcon A (PC 1-D MF)|Subjects were randomly assigned into either the omafilcon A (PC 1-D) Multifocal with +0.75D over-correction in the non-dominant eye or the Air Optix Aqua (lotrafilcon B)Multifocal lenses as their initial pair. Lens Pair 1 were evaluated for fit, vision and comfort (1 hour after lens application). Following this evaluation and during this same visit, the subject then crossed-over into the alternative pair of study lenses. This second pair of lenses was also evaluated for fit, vision and comfort (1 hour after lens application).
210069|NCT01526902|P1|Participant Flow|Omafilcon A (PC 1-D MF) / Lotrafilcon B (AIR OPTIX MF)|Subjects were randomly assigned into either the omafilcon A (PC 1-D) Multifocal with +0.75D over-correction in the non-dominant eye or the Air Optix Aqua (lotrafilcon B)Multifocal lenses as their initial pair. Lens Pair 1 were evaluated for fit, vision and comfort (1 hour after lens application). Following this evaluation and during this same visit, the subject then crossed-over into the alternative pair of study lenses. This second pair of lenses was also evaluated for fit, vision and comfort (1 hour after lens application).
210070|NCT01526902|O2|Outcome|Air Optix MF|(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
210071|NCT01526902|O1|Outcome|PC1DMF|(Test Lens) omafilcon A Proclear 1-D multifocal lens
210072|NCT01526902|O2|Outcome|Air Optix MF|(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
210073|NCT01526902|O1|Outcome|PC1DMF|(Test Lens) omafilcon A Proclear 1-D multifocal lens
210074|NCT01526902|O2|Outcome|Air Optix MF|(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
210075|NCT01526902|O1|Outcome|PC1DMF|(Test Lens) omafilcon A Proclear 1-D multifocal lens
210076|NCT01526902|O2|Outcome|Air Optix MF|(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
210077|NCT01526902|O1|Outcome|PC1DMF|(Test Lens) omafilcon A Proclear 1-D multifocal lens
210078|NCT01526902|O2|Outcome|Air Optix MF|(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
210079|NCT01526902|O1|Outcome|PC1DMF|(Test Lens) omafilcon A Proclear 1-D multifocal lens
210080|NCT01526902|O2|Outcome|Air Optix MF|(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
210081|NCT01526902|O1|Outcome|PC1DMF|(Test Lens) omafilcon A Proclear 1-D multifocal lens
210082|NCT01526902|E2|Reported Event|Lotrafilcon B / Air Optix MF (CONTROL)|Low-Med and High Add power groups were randomly assigned to either omafilcon A/Proclear Multifocal soft contact lenses (PC1DMF L2A) or lotrafilcon B/Air OPtix Aqua Multifocal soft contact lenses (Air Optix MF) then crossed-over into the alternative pair of study lenses.
210083|NCT01526902|E1|Reported Event|Omafilcon A / PC1DMF L2A (TEST)|Low-Med and High Add power groups were randomly assigned to either omafilcon A/Proclear Multifocal soft contact lenses (PC1DMF L2A) or lotrafilcon B/Air OPtix Aqua Multifocal soft contact lenses (Air Optix MF) then crossed-over into the alternative pair of study lenses.
210084|NCT01526785|B1|Baseline|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
210085|NCT01526785|P1|Participant Flow|Alglucosidase Alfa|Alglucosidase alfa (4000 litre [L] scale) intravenous (IV) infusion administered for 52 weeks as per physician's routine practice.
210086|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
210095|NCT01526733|P2|Participant Flow|Insulin-sham, Then Insulin-rHuPH20|"In Phase I, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with a sham injection administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~In Phase II, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Phase I and Phase II were separated by a washout period of 5 to 21 days."
210096|NCT01526733|P1|Participant Flow|Insulin-rHuPH20, Then Insulin-sham|"In Phase I, participants received 0.15 units per kilogram (U/kg) insulin (either insulin aspart or insulin lispro) as a continuous subcutaneous insulin infusion (CSII) for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 milliliter (mL) (150 U) injection of recombinant human hyaluronidase PH20 (rHuPH20).~In Phase II, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with a sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Phase I and II were separated by a washout period of 5 to 21 days."
210097|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Each Phase was separated by a washout period of 5 to 21 days."
210098|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
210099|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Each Phase was separated by a washout period of 5 to 21 days."
210100|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
210101|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Each Phase was separated by a washout period of 5 to 21 days."
210102|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
210103|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Each Phase was separated by a washout period of 5 to 21 days."
210104|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
210105|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Each Phase was separated by a washout period of 5 to 21 days."
210106|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
210107|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Each Phase was separated by a washout period of 5 to 21 days."
210108|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
210109|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Each Phase was separated by a washout period of 5 to 21 days."
210188|NCT01525849|B2|Baseline|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
210498|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
210110|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
210111|NCT01526733|E2|Reported Event|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Each Phase was separated by a washout period of 5 to 21 days."
210112|NCT01526733|E1|Reported Event|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
210113|NCT01526629|B1|Baseline|ICD Patients With Remote Follow-up|Patients implanted with a fully automatic ICD and remotely followed-up.
210114|NCT01526629|P1|Participant Flow|ICD Patients With Remote Follow-up|Patients implanted with a fully automatic ICD and remotely followed-up.
210115|NCT01526629|O1|Outcome|ICD Patients With Remote Follow-up|Patients implanted with a fully automatic ICD and remotely followed-up.
210116|NCT01526629|E1|Reported Event|ICD Patients With Remote Follow-up|Patients implanted with a fully automatic ICD and remotely followed-up.
210117|NCT01526551|B1|Baseline|Intervention School|"High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic~HPV Vaccine and Disease Education: Increased education of disease and vaccine~Reduction of barriers: eliminate barriers to being vaccinated"
210118|NCT01526551|P1|Participant Flow|Intervention School|"High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic~HPV Vaccine and Disease Education: Increased education of disease and vaccine~Reduction of barriers: eliminate barriers to being vaccinated"
210119|NCT01526551|O1|Outcome|Intervention School|"High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic~HPV Vaccine and Disease Education: Increased education of disease and vaccine~Reduction of barriers: eliminate barriers to being vaccinated"
210120|NCT01526551|O1|Outcome|Intervention School|"High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic~HPV Vaccine and Disease Education: Increased education of disease and vaccine~Reduction of barriers: eliminate barriers to being vaccinated"
210121|NCT01526551|E1|Reported Event|Intervention School|"High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic~HPV Vaccine and Disease Education: Increased education of disease and vaccine~Reduction of barriers: eliminate barriers to being vaccinated"
210122|NCT01526538|B3|Baseline|Total|Total of all reporting groups
210123|NCT01526538|B2|Baseline|Sugar Pill|"Inactive placebo~sugar pill: placebo"
210124|NCT01526538|B1|Baseline|50 mg D-cycloserine|"active drug condition~d-cycloserine: 50 mg d-cycloserine"
210125|NCT01526538|P2|Participant Flow|Sugar Pill|"Inactive placebo~sugar pill: placebo"
210126|NCT01526538|P1|Participant Flow|50 mg D-cycloserine|"active drug condition~d-cycloserine: 50 mg d-cycloserine"
210127|NCT01526538|O2|Outcome|Sugar Pill|"Inactive placebo~sugar pill: placebo"
210128|NCT01526538|O1|Outcome|50 mg D-cycloserine|"active drug condition~d-cycloserine: 50 mg d-cycloserine"
210129|NCT01526538|O2|Outcome|Control|Placebo (sugar pill)
210130|NCT01526538|O1|Outcome|D-cycloserine|Study medication under investigation
210131|NCT01526538|O2|Outcome|Sugar Pill|"Inactive placebo~sugar pill: placebo"
210132|NCT01526538|O1|Outcome|50 mg D-cycloserine|"active drug condition~d-cycloserine: 50 mg d-cycloserine"
210133|NCT01526538|E2|Reported Event|Sugar Pill|"Inactive placebo~sugar pill: placebo"
210134|NCT01526538|E1|Reported Event|50 mg D-cycloserine|"active drug condition~d-cycloserine: 50 mg d-cycloserine"
210135|NCT01526343|B1|Baseline|Reveal XT|Reveal XT implantation: The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy.
210136|NCT01526343|P1|Participant Flow|Reveal XT|Reveal XT implantation: The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy.
210137|NCT01526343|O1|Outcome|Reveal XT|Reveal XT implantation: The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy.
210138|NCT01526343|O1|Outcome|Reveal XT|Reveal XT implantation: The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy.
210139|NCT01526343|E1|Reported Event|Reveal XT|"Reveal XT implantation: The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy.~No reportable adverse events occurred."
210140|NCT01526213|B7|Baseline|Total|Total of all reporting groups
210141|NCT01526213|B6|Baseline|Sequence 6: Furanocoumarin-free GFJ, Water, GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
210142|NCT01526213|B5|Baseline|Sequence 5: Furanocoumarin-free GFJ, GFJ, Water|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
210143|NCT01526213|B4|Baseline|Sequence 4: GFJ, Water, Furanocoumarin-free GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
210144|NCT01526213|B3|Baseline|Sequence 3: GFJ, Furanocoumarin-free GFJ, Water|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
210145|NCT01526213|B2|Baseline|Sequence 2: Water, Furanocoumarin-free GFJ, GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
210146|NCT01526213|B1|Baseline|Sequence 1: Water, GFJ, Furanocoumarin-free GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
210147|NCT01526213|P6|Participant Flow|Sequence 6: Furanocoumarin-free GFJ, Water, GFJ|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
210148|NCT01526213|P5|Participant Flow|Sequence 5: Furanocoumarin-free GFJ, GFJ, Water|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
210149|NCT01526213|P4|Participant Flow|Sequence 4: GFJ, Water, Furanocoumarin-free GFJ|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
210150|NCT01526213|P3|Participant Flow|Sequence 3: GFJ, Furanocoumarin-free GFJ, Water|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
210151|NCT01526213|P2|Participant Flow|Sequence 2: Water, Furanocoumarin-free GFJ, GFJ|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
210152|NCT01526213|P1|Participant Flow|Sequence 1: Water, GFJ, Furanocoumarin-free GFJ|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
210153|NCT01526213|O3|Outcome|Furanocoumarin-free Grapefruit Juice|For juice and water comparisons, fexofenadine + grapefruit juice or fexofenadine + furanocoumarin-free grapefruit juice will be the test agent (numerator) and fexofenadine + water will be the reference standard (denominator).
210154|NCT01526213|O2|Outcome|Grapefruit Juice|For juice and water comparisons, fexofenadine + grapefruit juice or fexofenadine + furanocoumarin-free grapefruit juice will be the test agent (numerator) and fexofenadine + water will be the reference standard (denominator).
210155|NCT01526213|O1|Outcome|Water|For juice and water comparisons, fexofenadine + grapefruit juice or fexofenadine + furanocoumarin-free grapefruit juice will be the test agent (numerator) and fexofenadine + water will be the reference standard (denominator).
210156|NCT01526213|E6|Reported Event|Sequence 6: Furanocoumarin-free GFJ, Water, GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
210157|NCT01526213|E5|Reported Event|Sequence 5: Furanocoumarin-free GFJ, GFJ, Water|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
210158|NCT01526213|E4|Reported Event|Sequence 4: GFJ, Water, Furanocoumarin-free GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
210189|NCT01525849|B1|Baseline|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
210159|NCT01526213|E3|Reported Event|Sequence 3: GFJ, Furanocoumarin-free GFJ, Water|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
210160|NCT01526213|E2|Reported Event|Sequence 2: Water, Furanocoumarin-free GFJ, GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
210161|NCT01526213|E1|Reported Event|Sequence 1: Water, GFJ, Furanocoumarin-free GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
210162|NCT01526148|B3|Baseline|Total|Total of all reporting groups
210163|NCT01526148|B2|Baseline|Quetiapine|Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
210164|NCT01526148|B1|Baseline|Lithium|Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
210165|NCT01526148|P2|Participant Flow|Quetiapine|Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
210166|NCT01526148|P1|Participant Flow|Lithium|Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
210167|NCT01526148|O2|Outcome|Quetiapine|Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
210168|NCT01526148|O1|Outcome|Lithium|Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
210169|NCT01526148|O2|Outcome|Quetiapine|Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
210170|NCT01526148|O1|Outcome|Lithium|Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
210171|NCT01526148|E2|Reported Event|Quetiapine|Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
210172|NCT01526148|E1|Reported Event|Lithium|Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
210173|NCT01525927|B3|Baseline|Total|Total of all reporting groups
210174|NCT01525927|B2|Baseline|Chemotherapy Responders|"Patients who respond to chemotherapy are treated with reduced dose radiotherapy.~chemotherapy: Chemotherapy for three cycles prior to radiotherapy~Reduced dose radiotherapy: Patients who achieve a response to chemotherapy then go on to receive reduced dose radiotherapy."
210175|NCT01525927|B1|Baseline|Chemotherapy Non-responders|"Patients treated with three cycles neoadjuvant chemotherapy who do not exhibit response to chemotherapy are then allocated to recieve standard dose and schedule radiotherapy.~chemotherapy: Chemotherapy for three cycles prior to radiotherapy~radiotherapy: Standard radiotherapy for non-responders vs reduced dose radiotherapy for responders."
210176|NCT01525927|P1|Participant Flow|Chemotherapy Responders|"Patients who respond to chemotherapy are treated with reduced dose radiotherapy.~chemotherapy: Chemotherapy for three cycles prior to radiotherapy~Reduced dose radiotherapy: Patients who achieve a response to chemotherapy then go on to receive reduced dose radiotherapy."
210177|NCT01525927|O1|Outcome|No Study Intervention or Data Collected- Zero (0) Participants|No study intervention or data collected- Zero (0) participants analyzed
210178|NCT01525927|O1|Outcome|No Study Intervention or Data Collected- Zero (0) Participants|No study intervention or data collected- Zero (0) participants analyzed
210179|NCT01525927|O1|Outcome|No Study Intervention or Data Collected- Zero (0) Participants|No study intervention or data collected- Zero (0) participants analyzed
210180|NCT01525927|O1|Outcome|No Study Intervention or Data Collected- Zero (0) Participants|No study intervention or data collected- Zero (0) participants analyzed
210181|NCT01525927|O1|Outcome|No Study Intervention or Data Collected- Zero (0) Participants|No study intervention or data collected- Zero (0) participants analyzed
210182|NCT01525927|O1|Outcome|No Study Intervention or Data Collected- Zero (0) Participants|No study intervention or data collected- Zero (0) participants analyzed
210183|NCT01525927|O1|Outcome|No Study Intervention or Data Collected- Zero (0) Participants|No study intervention or data collected- Zero (0) participants analyzed
210184|NCT01525927|O1|Outcome|Chemotherapy Responders|"Patients who respond to chemotherapy are treated with reduced dose radiotherapy.~chemotherapy: Chemotherapy for three cycles prior to radiotherapy~Reduced dose radiotherapy: Patients who achieve a response to chemotherapy then go on to receive reduced dose radiotherapy."
210185|NCT01525927|E2|Reported Event|Chemotherapy Responders|"Patients who respond to chemotherapy are treated with reduced dose radiotherapy.~chemotherapy: Chemotherapy for three cycles prior to radiotherapy~Reduced dose radiotherapy: Patients who achieve a response to chemotherapy then go on to receive reduced dose radiotherapy.~Zero (0) participants analyzed"
210186|NCT01525927|E1|Reported Event|Chemotherapy Non-responders|"Patients treated with three cycles neoadjuvant chemotherapy who do not exhibit response to chemotherapy are then allocated to recieve standard dose and schedule radiotherapy.~chemotherapy: Chemotherapy for three cycles prior to radiotherapy~radiotherapy: Standard radiotherapy for non-responders vs reduced dose radiotherapy for responders.~Zero (0) participants analyzed"
210187|NCT01525849|B3|Baseline|Total|Total of all reporting groups
210190|NCT01525849|P2|Participant Flow|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
210191|NCT01525849|P1|Participant Flow|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
210192|NCT01525849|O2|Outcome|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
210193|NCT01525849|O1|Outcome|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
210194|NCT01525849|O2|Outcome|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
210195|NCT01525849|O1|Outcome|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
210196|NCT01525849|O2|Outcome|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
210197|NCT01525849|O1|Outcome|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
210198|NCT01525849|O2|Outcome|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
210199|NCT01525849|O1|Outcome|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
210200|NCT01525849|O2|Outcome|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
210201|NCT01525849|O1|Outcome|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
210202|NCT01525849|E2|Reported Event|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
210203|NCT01525849|E1|Reported Event|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
210204|NCT01525745|B3|Baseline|Total|Total of all reporting groups
210205|NCT01525745|B2|Baseline|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
210206|NCT01525745|B1|Baseline|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
210207|NCT01525745|P2|Participant Flow|External Beam Radiation Therapy|"External Beam Radiation Therapy~External Beam Radiation Therapy: 10 consecutive days of standard radiation"
210208|NCT01525745|P1|Participant Flow|Radiosurgery/SBRT|"Radiosurgery/SBRT~Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments"
210209|NCT01525745|O2|Outcome|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
210210|NCT01525745|O1|Outcome|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
210211|NCT01525745|O2|Outcome|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
210212|NCT01525745|O1|Outcome|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
210213|NCT01525745|O2|Outcome|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
210214|NCT01525745|O1|Outcome|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
210215|NCT01525745|O2|Outcome|External Beam Radiation Therapy|"External Beam Radiation Therapy~External Beam Radiation Therapy: 10 consecutive days of standard radiation"
210216|NCT01525745|O1|Outcome|Radiosurgery/SBRT|"Radiosurgery/SBRT~Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments"
210217|NCT01525745|O2|Outcome|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
210218|NCT01525745|O1|Outcome|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
210219|NCT01525745|E2|Reported Event|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
210220|NCT01525745|E1|Reported Event|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
210221|NCT01525667|B4|Baseline|Total|Total of all reporting groups
210222|NCT01525667|B3|Baseline|Placebo|Placebo: Single treatment, multiple injections
210223|NCT01525667|B2|Baseline|PLX-PAD High Dose|PLX-PAD high dose: Single treatment, multiple injections
210224|NCT01525667|B1|Baseline|PLX-PAD Low Dose|PLX-PAD low dose: Single treatment, multiple injections
210225|NCT01525667|P3|Participant Flow|Placebo|Placebo: Single treatment, multiple injections
210226|NCT01525667|P2|Participant Flow|PLX-PAD High Dose|300M PLX-PAD : Single treatment, multiple injections
210227|NCT01525667|P1|Participant Flow|PLX-PAD Low Dose|150M PLX-PAD : Single treatment, multiple injections
210228|NCT01525667|O3|Outcome|Placebo|Placebo: Single treatment, multiple injections
210229|NCT01525667|O2|Outcome|300M PLX-PAD|PLX-PAD high dose: Single treatment, multiple injections
210230|NCT01525667|O1|Outcome|150M PLX-PAD|PLX-PAD low dose: Single treatment, multiple injections
210231|NCT01525667|O3|Outcome|Placebo|Placebo: Single treatment, multiple injections
210232|NCT01525667|O2|Outcome|300M PLX-PAD|PLX-PAD high dose: Single treatment, multiple injections
210233|NCT01525667|O1|Outcome|150M PLX-PAD|PLX-PAD low dose: Single treatment, multiple injections
210234|NCT01525667|O3|Outcome|Placebo|Placebo: Single treatment, multiple injections
210235|NCT01525667|O2|Outcome|300M PLX-PAD|PLX-PAD high dose: Single treatment, multiple injections
210236|NCT01525667|O1|Outcome|150M PLX-PAD|PLX-PAD low dose: Single treatment, multiple injections
210237|NCT01525667|O3|Outcome|Placebo|Placebo: Single treatment, multiple injections
210238|NCT01525667|O2|Outcome|300M PLX-PAD|PLX-PAD high dose: Single treatment, multiple injections
210239|NCT01525667|O1|Outcome|150M PLX-PAD|PLX-PAD low dose: Single treatment, multiple injections
210240|NCT01525667|O3|Outcome|Placebo|Placebo: Single treatment, multiple injections
210246|NCT01525641|B1|Baseline|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
210247|NCT01525641|P1|Participant Flow|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
210248|NCT01525641|O1|Outcome|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
210249|NCT01525641|O1|Outcome|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
210250|NCT01525641|O1|Outcome|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
210251|NCT01525641|O1|Outcome|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
210252|NCT01525641|O1|Outcome|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
210253|NCT01525641|O1|Outcome|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
210254|NCT01525641|E1|Reported Event|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
210255|NCT01525628|B6|Baseline|Total|Total of all reporting groups
210256|NCT01525628|B5|Baseline|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
210257|NCT01525628|B4|Baseline|Group D|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily with probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66).
210258|NCT01525628|B3|Baseline|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
210259|NCT01525628|B2|Baseline|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210339|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210340|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
210260|NCT01525628|B1|Baseline|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210261|NCT01525628|P5|Participant Flow|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
210262|NCT01525628|P4|Participant Flow|Group D|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily with probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66).
210263|NCT01525628|P3|Participant Flow|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
210264|NCT01525628|P2|Participant Flow|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210265|NCT01525628|P1|Participant Flow|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210266|NCT01525628|O5|Outcome|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
210267|NCT01525628|O4|Outcome|Group D|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily with probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66).
210268|NCT01525628|O3|Outcome|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
210269|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210270|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210271|NCT01525628|O1|Outcome|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
210272|NCT01525628|O1|Outcome|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
210273|NCT01525628|O1|Outcome|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
210274|NCT01525628|O1|Outcome|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
210275|NCT01525628|O1|Outcome|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
210276|NCT01525628|O1|Outcome|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
210277|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210278|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210279|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210280|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210281|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210282|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210283|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210284|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210285|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210286|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210287|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210288|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210289|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210290|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210291|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210292|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210293|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210294|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210295|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210296|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210297|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210298|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210299|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210300|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210301|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210302|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210303|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210304|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210305|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210306|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210307|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210308|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210309|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210310|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210311|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210312|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210313|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210314|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210315|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210316|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210317|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210318|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210319|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210320|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210321|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210322|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210323|NCT01525628|E5|Reported Event|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
210324|NCT01525628|E4|Reported Event|Group D|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily with probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66).
210325|NCT01525628|E3|Reported Event|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
210326|NCT01525628|E2|Reported Event|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210327|NCT01525628|E1|Reported Event|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
210328|NCT01525615|B4|Baseline|Total|Total of all reporting groups
210329|NCT01525615|B3|Baseline|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210330|NCT01525615|B2|Baseline|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210331|NCT01525615|B1|Baseline|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
210332|NCT01525615|P3|Participant Flow|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210333|NCT01525615|P2|Participant Flow|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210334|NCT01525615|P1|Participant Flow|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
210335|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210336|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210337|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
210338|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210373|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
210341|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210342|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210343|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
210344|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210345|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210346|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
210347|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210348|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210349|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
210350|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210351|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210352|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
210353|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210354|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210355|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
210356|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210357|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210358|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
210359|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210360|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210361|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
210362|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210363|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210364|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
210365|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210366|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210367|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
210368|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210369|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210370|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
210371|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210372|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210374|NCT01525615|E3|Reported Event|Tio+Olo 5.0 / 5.0 μg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210375|NCT01525615|E2|Reported Event|Tio+Olo 2.5 / 5.0 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
210376|NCT01525615|E1|Reported Event|Placebo|once daily 2 puffs, solution for inhalation Respimat placebo to tiotropium+olodaterol: comparator
210377|NCT01525563|B1|Baseline|Subjects With Irregular Menstrual Cycle|Adult subjects with irregular menstrual cycle and can be treated with Duphaston as per locally approved label can be enrolled.
210378|NCT01525563|P1|Participant Flow|Subjects With Irregular Menstrual Cycle|Adult subjects with irregular menstrual cycle and can be treated with Duphaston as per locally approved label can be enrolled.
210379|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
210380|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
210381|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
210382|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
210383|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
210384|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
210385|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
210386|NCT01525563|E1|Reported Event|Subjects With Irregular Menstrual Cycle|Adult subjects with irregular menstrual cycle and can be treated with Duphaston as per locally approved label can be enrolled.
210387|NCT01525550|B3|Baseline|Total|Total of all reporting groups
210388|NCT01525550|B2|Baseline|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210389|NCT01525550|B1|Baseline|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210390|NCT01525550|P2|Participant Flow|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210391|NCT01525550|P1|Participant Flow|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210392|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210393|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210394|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210395|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210396|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210397|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210398|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210399|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210485|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
210486|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
210400|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210401|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210402|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210403|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210404|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210405|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210406|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210407|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210408|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210409|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210410|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210411|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210412|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210413|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210414|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210415|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210416|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210417|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210418|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210419|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210420|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210421|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210487|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
210422|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210423|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210424|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210425|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210426|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210427|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210428|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210429|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210430|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210431|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210432|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210433|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210434|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210435|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210436|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210437|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210438|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210439|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210440|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210441|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210442|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210443|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210488|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
210444|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210445|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210446|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210447|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210448|NCT01525550|E2|Reported Event|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
210449|NCT01525550|E1|Reported Event|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
210450|NCT01525420|B3|Baseline|Total|Total of all reporting groups
210451|NCT01525420|B2|Baseline|Cognitive Behavioral Therapy (CBT)|"CBT~Cognitive Behavioral Therapy (CBT): ACT: This is the control arm of the study. This included 5 weekly sessions of CBT therapy via telephone."
210452|NCT01525420|B1|Baseline|Acceptance & Commitment Therapy (ACT)|"ACT~Acceptance & Commitment Therapy (ACT): This is the experimental arm of the study. This included 5 weekly sessions of ACT therapy via telephone."
210453|NCT01525420|P2|Participant Flow|Cognitive Behavioral Therapy (CBT)|"CBT~Cognitive Behavioral Therapy (CBT): CBT~This is the control arm of the study. This included 5 weekly sessions of CBT therapy via telephone."
210454|NCT01525420|P1|Participant Flow|Acceptance & Commitment Therapy (ACT)|"ACT~Acceptance & Commitment Therapy (ACT): ACT~This is the experimental arm of the study. This included 5 weekly sessions of ACT therapy via telephone."
210455|NCT01525420|O2|Outcome|Cognitive Behavioral Therapy (CBT)|"CBT~Cognitive Behavioral Therapy (CBT): CBT"
210456|NCT01525420|O1|Outcome|Acceptance & Commitment Therapy (ACT)|"ACT~Acceptance & Commitment Therapy (ACT): ACT"
210457|NCT01525420|E2|Reported Event|Cognitive Behavioral Therapy (CBT)|"CBT~Cognitive Behavioral Therapy (CBT): CBT"
210458|NCT01525420|E1|Reported Event|Acceptance & Commitment Therapy (ACT)|"ACT~Acceptance & Commitment Therapy (ACT): ACT"
210459|NCT01525407|B3|Baseline|Total|Total of all reporting groups
210460|NCT01525407|B2|Baseline|Patients|Recipients of donor stem cells.
210461|NCT01525407|B1|Baseline|Donors|"Donors receive atorvastatin calcium PO beginning on day -14 and continuing until the last day of stem cell collection.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo myeloablative allogeneic PBSC transplant~Atorvastatin Calcium: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo myeloablative allogeneic PBSC transplant"
210462|NCT01525407|P2|Participant Flow|Patients|Recipients of donor stem cells.
210463|NCT01525407|P1|Participant Flow|Donors|"Donors receive atorvastatin calcium PO beginning on day -14 and continuing until the last day of stem cell collection.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo myeloablative allogeneic PBSC transplant~Atorvastatin Calcium: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo myeloablative allogeneic PBSC transplant"
210464|NCT01525407|O1|Outcome|Patients|Recipients of donor stem cells.
210465|NCT01525407|O1|Outcome|Patients|Recipients of donor stem cells.
210466|NCT01525407|O1|Outcome|Donors|"Donors receive atorvastatin calcium PO beginning on day -14 and continuing until the last day of stem cell collection.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo myeloablative allogeneic PBSC transplant~Atorvastatin Calcium: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo myeloablative allogeneic PBSC transplant"
210467|NCT01525407|O1|Outcome|Patients|Recipients of donor stem cells.
210468|NCT01525407|O1|Outcome|Patients|Recipients of donor stem cells.
210469|NCT01525407|O1|Outcome|Patients|Recipients of donor stem cells.
210470|NCT01525407|O1|Outcome|Patients|Recipients of donor stem cells.
210471|NCT01525407|O1|Outcome|Patients|Recipients of donor stem cells.
210472|NCT01525407|O1|Outcome|Patients|Recipients of donor stem cells.
210473|NCT01525407|O1|Outcome|Patients|Recipients of donor stem cells.
210474|NCT01525407|E2|Reported Event|Donor Adverse Events|Donor: SAEs, AEs (≥ grade 2) and UPs will be monitored and recorded from the time the donor starts atorvastatin therapy through the time of discharge from the transplant center after donation of stem cells or 7 days after the discontinuation of the medication, whichever occurs earlier.
210475|NCT01525407|E1|Reported Event|Patient Adverse Events|Recipient: SAEs and UPs (life-threatening or fatal) will be monitored and recorded from the time the recipient starts conditioning therapy through day 100 or discharge from the center, whichever occurs earlier.
210476|NCT01525238|B4|Baseline|Total|Total of all reporting groups
210477|NCT01525238|B3|Baseline|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
210478|NCT01525238|B2|Baseline|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
210479|NCT01525238|B1|Baseline|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
210480|NCT01525238|P3|Participant Flow|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
210481|NCT01525238|P2|Participant Flow|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
210482|NCT01525238|P1|Participant Flow|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
210483|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
210484|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
210499|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
210500|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
210501|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
210502|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
210503|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
210504|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
210505|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
210506|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
210507|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
210508|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
210509|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
210510|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
210511|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
210512|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
210513|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
210514|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
210515|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
210516|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
210517|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
210518|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
210519|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
210520|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
210521|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
210522|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
210523|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
210524|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
210525|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
210526|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
210527|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
210528|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
210529|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
210530|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
210531|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
210532|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
210533|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
210534|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
210535|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
210536|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
210537|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
210538|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
210539|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
210540|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
210541|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
210542|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
210543|NCT01525238|E3|Reported Event|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
210544|NCT01525238|E2|Reported Event|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
210545|NCT01525238|E1|Reported Event|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
210546|NCT01525225|B1|Baseline|Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC|Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® IR tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin XR FDC tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
210547|NCT01525225|P1|Participant Flow|Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC|Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® immediate release (IR) tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
210548|NCT01525225|O1|Outcome|Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC|Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® IR tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin XR FDC tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
210581|NCT01524978|P2|Participant Flow|Cohort 2: Ovarian Cancer - Vemurafenib|Participants with ovarian cancer were treated with vemurafenib monotherapy.
210582|NCT01524978|P1|Participant Flow|Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib|Participants with NSCLC were treated with vemurafenib monotherapy.
210549|NCT01525225|O1|Outcome|Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC|Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® IR tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin XR FDC tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
210550|NCT01525225|E1|Reported Event|Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC|Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® IR tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin XR FDC tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
210551|NCT01525173|B3|Baseline|Total|Total of all reporting groups
210552|NCT01525173|B2|Baseline|LUMIGAN® Alone|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
210553|NCT01525173|B1|Baseline|ALPHAGAN® P and LUMIGAN®|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
210554|NCT01525173|P2|Participant Flow|LUMIGAN® Alone|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
210555|NCT01525173|P1|Participant Flow|ALPHAGAN® P and LUMIGAN®|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
210556|NCT01525173|O2|Outcome|LUMIGAN® Alone|1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
210557|NCT01525173|O1|Outcome|ALPHAGAN® P and LUMIGAN®|1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
210558|NCT01525173|E2|Reported Event|LUMIGAN® Alone|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
210559|NCT01525173|E1|Reported Event|ALPHAGAN® P and LUMIGAN®|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
210560|NCT01524978|B12|Baseline|Total|Total of all reporting groups
210561|NCT01524978|B11|Baseline|Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib|Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
210562|NCT01524978|B10|Baseline|Cohort 7d: Early Stage Astrocytoma - Vemurafenib|Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
210563|NCT01524978|B9|Baseline|Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib|Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
210564|NCT01524978|B8|Baseline|Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib|Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
210565|NCT01524978|B7|Baseline|Cohort 7a: ECD/LCH - Vemurafenib|Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
210566|NCT01524978|B6|Baseline|Cohort 6: Multiple Myeloma - Vemurafenib|Participants with multiple myeloma were treated with vemurafenib monotherapy.
210567|NCT01524978|B5|Baseline|Cohort 4: Cholangiocarcinoma - Vemurafenib|Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
210568|NCT01524978|B4|Baseline|Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab|Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
210569|NCT01524978|B3|Baseline|Cohort 3a: Colorectal Cancer - Vemurafenib|Participants with colorectal cancer were treated with vemurafenib monotherapy.
210570|NCT01524978|B2|Baseline|Cohort 2: Ovarian Cancer - Vemurafenib|Participants with ovarian cancer were treated with vemurafenib monotherapy.
210571|NCT01524978|B1|Baseline|Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib|Participants with NSCLC were treated with vemurafenib monotherapy.
210572|NCT01524978|P11|Participant Flow|Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib|Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
210573|NCT01524978|P10|Participant Flow|Cohort 7d: Early Stage Astrocytoma - Vemurafenib|Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
210574|NCT01524978|P9|Participant Flow|Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib|Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
210575|NCT01524978|P8|Participant Flow|Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib|Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
210576|NCT01524978|P7|Participant Flow|Cohort 7a: ECD/LCH - Vemurafenib|Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
210577|NCT01524978|P6|Participant Flow|Cohort 6: Multiple Myeloma - Vemurafenib|Participants with multiple myeloma were treated with vemurafenib monotherapy.
210578|NCT01524978|P5|Participant Flow|Cohort 4: Cholangiocarcinoma - Vemurafenib|Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
210579|NCT01524978|P4|Participant Flow|Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab|Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
210580|NCT01524978|P3|Participant Flow|Cohort 3a: Colorectal Cancer - Vemurafenib|Participants with colorectal cancer were treated with vemurafenib monotherapy.
210583|NCT01524978|O11|Outcome|Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib|Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
210584|NCT01524978|O10|Outcome|Cohort 7d: Early Stage Astrocytoma - Vemurafenib|Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
210585|NCT01524978|O9|Outcome|Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib|Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
210586|NCT01524978|O8|Outcome|Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib|Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
210587|NCT01524978|O7|Outcome|Cohort 7a: ECD/LCH - Vemurafenib|Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
210588|NCT01524978|O6|Outcome|Cohort 6: Multiple Myeloma - Vemurafenib|Participants with multiple myeloma were treated with vemurafenib monotherapy.
210589|NCT01524978|O5|Outcome|Cohort 4: Cholangiocarcinoma - Vemurafenib|Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
210590|NCT01524978|O4|Outcome|Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab|Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
210591|NCT01524978|O3|Outcome|Cohort 3a: Colorectal Cancer - Vemurafenib|Participants with colorectal cancer were treated with vemurafenib monotherapy.
210592|NCT01524978|O2|Outcome|Cohort 2: Ovarian Cancer - Vemurafenib|Participants with ovarian cancer were treated with vemurafenib monotherapy.
210593|NCT01524978|O1|Outcome|Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib|Participants with NSCLC were treated with vemurafenib monotherapy.
210594|NCT01524978|O11|Outcome|Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib|Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
210595|NCT01524978|O10|Outcome|Cohort 7d: Early Stage Astrocytoma - Vemurafenib|Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
210596|NCT01524978|O9|Outcome|Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib|Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
210597|NCT01524978|O8|Outcome|Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib|Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
210598|NCT01524978|O7|Outcome|Cohort 7a: ECD/LCH - Vemurafenib|Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
210599|NCT01524978|O6|Outcome|Cohort 6: Multiple Myeloma - Vemurafenib|Participants with multiple myeloma were treated with vemurafenib monotherapy.
210600|NCT01524978|O5|Outcome|Cohort 4: Cholangiocarcinoma - Vemurafenib|Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
210601|NCT01524978|O4|Outcome|Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab|Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
210602|NCT01524978|O3|Outcome|Cohort 3a: Colorectal Cancer - Vemurafenib|Participants with colorectal cancer were treated with vemurafenib monotherapy.
210603|NCT01524978|O2|Outcome|Cohort 2: Ovarian Cancer - Vemurafenib|Participants with ovarian cancer were treated with vemurafenib monotherapy.
210604|NCT01524978|O1|Outcome|Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib|Participants with NSCLC were treated with vemurafenib monotherapy.
210605|NCT01524978|O11|Outcome|Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib|Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
210606|NCT01524978|O10|Outcome|Cohort 7d: Early Stage Astrocytoma - Vemurafenib|Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
210607|NCT01524978|O9|Outcome|Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib|Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
210608|NCT01524978|O8|Outcome|Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib|Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
210609|NCT01524978|O7|Outcome|Cohort 7a: ECD/LCH - Vemurafenib|Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
210610|NCT01524978|O6|Outcome|Cohort 6: Multiple Myeloma - Vemurafenib|Participants with multiple myeloma were treated with vemurafenib monotherapy.
210611|NCT01524978|O5|Outcome|Cohort 4: Cholangiocarcinoma - Vemurafenib|Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
210612|NCT01524978|O4|Outcome|Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab|Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
210613|NCT01524978|O3|Outcome|Cohort 3a: Colorectal Cancer - Vemurafenib|Participants with colorectal cancer were treated with vemurafenib monotherapy.
210614|NCT01524978|O2|Outcome|Cohort 2: Ovarian Cancer - Vemurafenib|Participants with ovarian cancer were treated with vemurafenib monotherapy.
210615|NCT01524978|O1|Outcome|Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib|Participants with NSCLC were treated with vemurafenib monotherapy.
210616|NCT01524978|O11|Outcome|Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib|Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
210617|NCT01524978|O10|Outcome|Cohort 7d: Early Stage Astrocytoma - Vemurafenib|Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
210618|NCT01524978|O9|Outcome|Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib|Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
210619|NCT01524978|O8|Outcome|Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib|Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
210620|NCT01524978|O7|Outcome|Cohort 7a: ECD/LCH - Vemurafenib|Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
210621|NCT01524978|O6|Outcome|Cohort 6: Multiple Myeloma - Vemurafenib|Participants with multiple myeloma were treated with vemurafenib monotherapy.
210622|NCT01524978|O5|Outcome|Cohort 4: Cholangiocarcinoma - Vemurafenib|Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
210623|NCT01524978|O4|Outcome|Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab|Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
211551|NCT01521780|O1|Outcome|Imaging and Imaging/Pathology|Magnetic resonance imaging (MRI) of HCC tumor.
210624|NCT01524978|O3|Outcome|Cohort 3a: Colorectal Cancer - Vemurafenib|Participants with colorectal cancer were treated with vemurafenib monotherapy.
210625|NCT01524978|O2|Outcome|Cohort 2: Ovarian Cancer - Vemurafenib|Participants with ovarian cancer were treated with vemurafenib monotherapy.
210626|NCT01524978|O1|Outcome|Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib|Participants with NSCLC were treated with vemurafenib monotherapy.
210627|NCT01524978|O11|Outcome|Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib|Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
210628|NCT01524978|O10|Outcome|Cohort 7d: Early Stage Astrocytoma - Vemurafenib|Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
210629|NCT01524978|O9|Outcome|Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib|Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
210630|NCT01524978|O8|Outcome|Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib|Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
210631|NCT01524978|O7|Outcome|Cohort 7a: ECD/LCH - Vemurafenib|Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
210632|NCT01524978|O6|Outcome|Cohort 6: Multiple Myeloma - Vemurafenib|Participants with multiple myeloma were treated with vemurafenib monotherapy.
210633|NCT01524978|O5|Outcome|Cohort 4: Cholangiocarcinoma - Vemurafenib|Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
210634|NCT01524978|O4|Outcome|Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab|Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
210635|NCT01524978|O3|Outcome|Cohort 3a: Colorectal Cancer - Vemurafenib|Participants with colorectal cancer were treated with vemurafenib monotherapy.
210636|NCT01524978|O2|Outcome|Cohort 2: Ovarian Cancer - Vemurafenib|Participants with ovarian cancer were treated with vemurafenib monotherapy.
210637|NCT01524978|O1|Outcome|Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib|Participants with NSCLC were treated with vemurafenib monotherapy.
210638|NCT01524978|O11|Outcome|Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib|Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
210639|NCT01524978|O10|Outcome|Cohort 7d: Early Stage Astrocytoma - Vemurafenib|Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
210640|NCT01524978|O9|Outcome|Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib|Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
210641|NCT01524978|O8|Outcome|Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib|Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
210642|NCT01524978|O7|Outcome|Cohort 7a: ECD/LCH - Vemurafenib|Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
210643|NCT01524978|O6|Outcome|Cohort 6: Multiple Myeloma - Vemurafenib|Participants with multiple myeloma were treated with vemurafenib monotherapy.
210644|NCT01524978|O5|Outcome|Cohort 4: Cholangiocarcinoma - Vemurafenib|Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
210645|NCT01524978|O4|Outcome|Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab|Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
210646|NCT01524978|O3|Outcome|Cohort 3a: Colorectal Cancer - Vemurafenib|Participants with colorectal cancer were treated with vemurafenib monotherapy.
210647|NCT01524978|O2|Outcome|Cohort 2: Ovarian Cancer - Vemurafenib|Participants with ovarian cancer were treated with vemurafenib monotherapy.
210648|NCT01524978|O1|Outcome|Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib|Participants with NSCLC were treated with vemurafenib monotherapy.
210649|NCT01524978|O11|Outcome|Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib|Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
210650|NCT01524978|O10|Outcome|Cohort 7d: Early Stage Astrocytoma - Vemurafenib|Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
210651|NCT01524978|O9|Outcome|Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib|Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
210652|NCT01524978|O8|Outcome|Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib|Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
210653|NCT01524978|O7|Outcome|Cohort 7a: ECD/LCH - Vemurafenib|Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
210654|NCT01524978|O6|Outcome|Cohort 6: Multiple Myeloma - Vemurafenib|Participants with multiple myeloma were treated with vemurafenib monotherapy.
210655|NCT01524978|O5|Outcome|Cohort 4: Cholangiocarcinoma - Vemurafenib|Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
210656|NCT01524978|O4|Outcome|Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab|Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
210657|NCT01524978|O3|Outcome|Cohort 3a: Colorectal Cancer - Vemurafenib|Participants with colorectal cancer were treated with vemurafenib monotherapy.
210658|NCT01524978|O2|Outcome|Cohort 2: Ovarian Cancer - Vemurafenib|Participants with ovarian cancer were treated with vemurafenib monotherapy.
210659|NCT01524978|O1|Outcome|Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib|Participants with NSCLC were treated with vemurafenib monotherapy.
210660|NCT01524978|O11|Outcome|Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib|Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
210661|NCT01524978|O10|Outcome|Cohort 7d: Early Stage Astrocytoma - Vemurafenib|Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
210662|NCT01524978|O9|Outcome|Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib|Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
210663|NCT01524978|O8|Outcome|Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib|Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
210664|NCT01524978|O7|Outcome|Cohort 7a: ECD/LCH - Vemurafenib|Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
210665|NCT01524978|O6|Outcome|Cohort 6: Multiple Myeloma - Vemurafenib|Participants with multiple myeloma were treated with vemurafenib monotherapy.
210666|NCT01524978|O5|Outcome|Cohort 4: Cholangiocarcinoma - Vemurafenib|Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
210667|NCT01524978|O4|Outcome|Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab|Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
210668|NCT01524978|O3|Outcome|Cohort 3a: Colorectal Cancer - Vemurafenib|Participants with colorectal cancer were treated with vemurafenib monotherapy.
210669|NCT01524978|O2|Outcome|Cohort 2: Ovarian Cancer - Vemurafenib|Participants with ovarian cancer were treated with vemurafenib monotherapy.
210670|NCT01524978|O1|Outcome|Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib|Participants with NSCLC were treated with vemurafenib monotherapy.
210671|NCT01524978|O11|Outcome|Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib|Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
210672|NCT01524978|O10|Outcome|Cohort 7d: Early Stage Astrocytoma - Vemurafenib|Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
210673|NCT01524978|O9|Outcome|Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib|Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
210674|NCT01524978|O8|Outcome|Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib|Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
210675|NCT01524978|O7|Outcome|Cohort 7a: ECD/LCH - Vemurafenib|Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
210676|NCT01524978|O6|Outcome|Cohort 6: Multiple Myeloma - Vemurafenib|Participants with multiple myeloma were treated with vemurafenib monotherapy.
210677|NCT01524978|O5|Outcome|Cohort 4: Cholangiocarcinoma - Vemurafenib|Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
210678|NCT01524978|O4|Outcome|Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab|Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
210679|NCT01524978|O3|Outcome|Cohort 3a: Colorectal Cancer - Vemurafenib|Participants with colorectal cancer were treated with vemurafenib monotherapy.
210680|NCT01524978|O2|Outcome|Cohort 2: Ovarian Cancer - Vemurafenib|Participants with ovarian cancer were treated with vemurafenib monotherapy.
210681|NCT01524978|O1|Outcome|Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib|Participants with NSCLC were treated with vemurafenib monotherapy.
210682|NCT01524978|O11|Outcome|Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib|Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
210683|NCT01524978|O10|Outcome|Cohort 7d: Early Stage Astrocytoma - Vemurafenib|Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
210684|NCT01524978|O9|Outcome|Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib|Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
210685|NCT01524978|O8|Outcome|Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib|Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
210686|NCT01524978|O7|Outcome|Cohort 7a: ECD/LCH - Vemurafenib|Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
210687|NCT01524978|O6|Outcome|Cohort 6: Multiple Myeloma - Vemurafenib|Participants with multiple myeloma were treated with vemurafenib monotherapy.
210688|NCT01524978|O5|Outcome|Cohort 4: Cholangiocarcinoma - Vemurafenib|Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
210689|NCT01524978|O4|Outcome|Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab|Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
210690|NCT01524978|O3|Outcome|Cohort 3a: Colorectal Cancer - Vemurafenib|Participants with colorectal cancer were treated with vemurafenib monotherapy.
210691|NCT01524978|O2|Outcome|Cohort 2: Ovarian Cancer - Vemurafenib|Participants with ovarian cancer were treated with vemurafenib monotherapy.
210692|NCT01524978|O1|Outcome|Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib|Participants with NSCLC were treated with vemurafenib monotherapy.
210693|NCT01524978|O11|Outcome|Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib|Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
210694|NCT01524978|O10|Outcome|Cohort 7d: Early Stage Astrocytoma - Vemurafenib|Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
210695|NCT01524978|O9|Outcome|Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib|Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
210696|NCT01524978|O8|Outcome|Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib|Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
210697|NCT01524978|O7|Outcome|Cohort 7a: ECD/LCH - Vemurafenib|Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
210698|NCT01524978|O6|Outcome|Cohort 6: Multiple Myeloma - Vemurafenib|Participants with multiple myeloma were treated with vemurafenib monotherapy.
210699|NCT01524978|O5|Outcome|Cohort 4: Cholangiocarcinoma - Vemurafenib|Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
210700|NCT01524978|O4|Outcome|Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab|Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
210701|NCT01524978|O3|Outcome|Cohort 3a: Colorectal Cancer - Vemurafenib|Participants with colorectal cancer were treated with vemurafenib monotherapy.
210702|NCT01524978|O2|Outcome|Cohort 2: Ovarian Cancer - Vemurafenib|Participants with ovarian cancer were treated with vemurafenib monotherapy.
210703|NCT01524978|O1|Outcome|Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib|Participants with NSCLC were treated with vemurafenib monotherapy.
210704|NCT01524978|E2|Reported Event|Pooled Arm - Vemurafenib|Participants with a variety of cancer types, who were treated with vemurafenib monotherapy, were combined into this arm.
210705|NCT01524978|E1|Reported Event|Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab|Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
210706|NCT01524913|B4|Baseline|Total|Total of all reporting groups
210707|NCT01524913|B3|Baseline|Saline Placebo|Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
210708|NCT01524913|B2|Baseline|Hyaluronic Acid|Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
210709|NCT01524913|B1|Baseline|Corticosteroid|Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
210710|NCT01524913|P3|Participant Flow|Saline Placebo|Participants in this group received 1 milliliter (mL) of lactated Ringer's solution injected into the superior joint space.
210711|NCT01524913|P2|Participant Flow|Hyaluronic Acid|Participants in the group received 1milliliter (mL) of Hyalgan (10 mg/mL) injected into the superior joint space.
210712|NCT01524913|P1|Participant Flow|Corticosteroid|Participants in this group received 1 milliliter (mL) of Celestone (6mg/mL) injected into the the superior joint space.
210713|NCT01524913|O3|Outcome|Saline Placebo|Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
210714|NCT01524913|O2|Outcome|Hyaluronic Acid|Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
210715|NCT01524913|O1|Outcome|Corticosteroid|Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
210716|NCT01524913|O3|Outcome|Saline Placebo|Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
210717|NCT01524913|O2|Outcome|Hyaluronic Acid|Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
210718|NCT01524913|O1|Outcome|Corticosteroid|Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
210719|NCT01524913|O3|Outcome|Saline Placebo|Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
210720|NCT01524913|O2|Outcome|Hyaluronic Acid|Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
210721|NCT01524913|O1|Outcome|Corticosteroid|Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
210722|NCT01524913|O3|Outcome|Saline Placebo|Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
210723|NCT01524913|O2|Outcome|Hyaluronic Acid|Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
210724|NCT01524913|O1|Outcome|Corticosteroid|Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
210725|NCT01524913|E3|Reported Event|Saline Placebo|Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
210726|NCT01524913|E2|Reported Event|Hyaluronic Acid|Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
210727|NCT01524913|E1|Reported Event|Corticosteroid|Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
210728|NCT01524900|B6|Baseline|Total|Total of all reporting groups
210729|NCT01524900|B5|Baseline|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
210730|NCT01524900|B4|Baseline|Pretreated Patients, Baseline Viral Load>50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
210731|NCT01524900|B3|Baseline|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
210732|NCT01524900|B2|Baseline|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
210733|NCT01524900|B1|Baseline|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
210734|NCT01524900|P5|Participant Flow|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
210735|NCT01524900|P4|Participant Flow|Pretreated Patients, Baseline Viral Load >50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
210736|NCT01524900|P3|Participant Flow|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
210737|NCT01524900|P2|Participant Flow|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
210738|NCT01524900|P1|Participant Flow|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
210739|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
210740|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load>50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
210741|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
210742|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
210743|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
210744|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
210745|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load>50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
210746|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
210747|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
210748|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
210749|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
210750|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load >50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
210751|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
210752|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
210753|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
210754|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
210755|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load >50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
210756|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
210757|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
210758|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
210759|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
210760|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load >50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
210761|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
210762|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
210763|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
210764|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
210765|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load >50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
210766|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
210767|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
210768|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
210769|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
210770|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load >50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
210771|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
210772|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
210773|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
210774|NCT01524900|E5|Reported Event|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
210775|NCT01524900|E4|Reported Event|Pretreated Patients, Baseline Viral Load > 50 Copies/ML|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
210776|NCT01524900|E3|Reported Event|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/ML|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
210777|NCT01524900|E2|Reported Event|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
210778|NCT01524900|E1|Reported Event|Treatment-naïve Patients|Patients who were not pretreated with HIV therapy
210779|NCT01524887|B4|Baseline|Total|Total of all reporting groups
210780|NCT01524887|B3|Baseline|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
210781|NCT01524887|B2|Baseline|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210782|NCT01524887|B1|Baseline|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210783|NCT01524887|P3|Participant Flow|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
210784|NCT01524887|P2|Participant Flow|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210785|NCT01524887|P1|Participant Flow|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210786|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
210787|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210788|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210789|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
210790|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210791|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210792|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
210793|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210794|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210795|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
210796|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210797|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210798|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
210799|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210800|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210801|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
210802|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210803|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210804|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
210805|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210806|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210807|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
210808|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210809|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210810|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
210811|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210812|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210813|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
210814|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210815|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210816|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
210817|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210818|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210819|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
210820|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210821|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210822|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
210823|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210824|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210825|NCT01524887|E3|Reported Event|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
210826|NCT01524887|E2|Reported Event|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210827|NCT01524887|E1|Reported Event|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
210828|NCT01524796|B1|Baseline|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
210829|NCT01524796|P1|Participant Flow|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
210830|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
210831|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
210832|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
210833|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
210834|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
210835|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
210836|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
210837|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
210838|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
210839|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
210840|NCT01524796|E1|Reported Event|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
210841|NCT01524783|B3|Baseline|Total|Total of all reporting groups
210842|NCT01524783|B2|Baseline|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
210843|NCT01524783|B1|Baseline|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
210844|NCT01524783|P2|Participant Flow|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
210845|NCT01524783|P1|Participant Flow|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
210846|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
210847|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
210848|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
210849|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
210850|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
210851|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
210852|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
210853|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
210854|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
210855|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
210856|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
210857|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
210858|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
210859|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
210860|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
210861|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
210862|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
210863|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
210864|NCT01524783|E2|Reported Event|Placebo + BSC|Placebo + BSC
210865|NCT01524783|E1|Reported Event|Everolimus + BSC|Everolimus + BSC
210866|NCT01524770|B1|Baseline|Entire Study Population|All participants who received at least one 1.5-milligram (mg) dose of dulaglutide administered subcutaneously via manual syringe or auto-injector.
210867|NCT01524770|P2|Participant Flow|Auto-injector First, Then Manual Syringe|"First Intervention:~Dulaglutide: A single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector.~There was a washout period of at least 28 days between treatment periods.~Second intervention:~Dulaglutide: A single dose of 1.5 mg dulaglutide administered SC by manual syringe."
210976|NCT01523886|O1|Outcome|Deep Neuromuscular Blockade|Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h
210977|NCT01523886|E2|Reported Event|Moderate Neuromuscular Blockade|Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
210868|NCT01524770|P1|Participant Flow|Manual Syringe First, Then Auto-injector|"First Intervention:~Dulaglutide: A single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe.~There was a washout period of at least 28 days between treatment periods.~Second intervention:~Dulaglutide: A single dose of 1.5 mg dulaglutide administered SC by auto-injector."
210869|NCT01524770|O2|Outcome|Manual Syringe|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period.
210870|NCT01524770|O1|Outcome|Auto-injector|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period.
210871|NCT01524770|O2|Outcome|Manual Syringe|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period.
210872|NCT01524770|O1|Outcome|Auto-injector|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period.
210873|NCT01524770|O2|Outcome|Manual Syringe|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period.
210874|NCT01524770|O1|Outcome|Auto-injector|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period.
210875|NCT01524770|E2|Reported Event|Manual Syringe|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period.
210876|NCT01524770|E1|Reported Event|Auto-injector|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period
210877|NCT01524692|B1|Baseline|Single ARM Dovitinib Treatment|"Single ARM Dovitinib treatment~Dovitinib (TKI258): 500 mg orally on a 5-days on/2-days off schedule each week of a 4-week (28-day) cycle. Treatment will continue until progression as defined by RECIST, unacceptable adverse events, patient refusal to continue on study, or physician's decision to withdraw the patient."
210878|NCT01524692|P1|Participant Flow|Single ARM Dovitinib Treatment|"Single ARM Dovitinib treatment~Dovitinib (TKI258): 500 mg orally on a 5-days on/2-days off schedule each week of a 4-week (28-day) cycle. Treatment will continue until progression as defined by RECIST, unacceptable adverse events, patient refusal to continue on study, or physician's decision to withdraw the patient."
210879|NCT01524692|O1|Outcome|Single ARM Dovitinib Treatment|"Single ARM Dovitinib treatment~Dovitinib (TKI258): 500 mg orally on a 5-days on/2-days off schedule each week of a 4-week (28-day) cycle. Treatment will continue until progression as defined by RECIST, unacceptable adverse events, patient refusal to continue on study, or physician's decision to withdraw the patient."
210880|NCT01524692|O1|Outcome|Single ARM Dovitinib Treatment|"Single ARM Dovitinib treatment~Dovitinib (TKI258): 500 mg orally on a 5-days on/2-days off schedule each week of a 4-week (28-day) cycle. Treatment will continue until progression as defined by RECIST, unacceptable adverse events, patient refusal to continue on study, or physician's decision to withdraw the patient."
210881|NCT01524692|O1|Outcome|Patients With Any Adverse Event|Patients with any adverse event as defined by CTCAE
210882|NCT01524692|O1|Outcome|Single ARM Dovitinib Treatment|"Single ARM Dovitinib treatment~Dovitinib (TKI258): 500 mg orally on a 5-days on/2-days off schedule each week of a 4-week (28-day) cycle. Treatment will continue until progression as defined by RECIST, unacceptable adverse events, patient refusal to continue on study, or physician's decision to withdraw the patient."
210883|NCT01524692|O1|Outcome|Single ARM Dovitinib Treatment|"Single ARM Dovitinib treatment~Dovitinib (TKI258): 500 mg orally on a 5-days on/2-days off schedule each week of a 4-week (28-day) cycle. Treatment will continue until progression as defined by RECIST, unacceptable adverse events, patient refusal to continue on study, or physician's decision to withdraw the patient."
210884|NCT01524692|E1|Reported Event|Single ARM Dovitinib Treatment|"Single ARM Dovitinib treatment~Dovitinib (TKI258): 500 mg orally on a 5-days on/2-days off schedule each week of a 4-week (28-day) cycle. Treatment will continue until progression as defined by RECIST, unacceptable adverse events, patient refusal to continue on study, or physician's decision to withdraw the patient."
210885|NCT01524627|B3|Baseline|Total|Total of all reporting groups
210886|NCT01524627|B2|Baseline|Varenicline|"Subjects will receive either varenicline or placebo~Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks."
210887|NCT01524627|B1|Baseline|Placebo|"Participants will receive either varenicline or placebo~Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks."
210888|NCT01524627|P2|Participant Flow|Varenicline|Varenicline will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
210889|NCT01524627|P1|Participant Flow|Placebo|Placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective as Varenicline: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
210890|NCT01524627|O2|Outcome|Varenicline|"Subjects will receive either varenicline or placebo~Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks."
210891|NCT01524627|O1|Outcome|Placebo|"Participants will receive either varenicline or placebo~Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks."
210978|NCT01523886|E1|Reported Event|Deep Neuromuscular Blockade|Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h
210892|NCT01524627|E2|Reported Event|Varenicline|"Subjects will receive either varenicline or placebo~Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks."
210893|NCT01524627|E1|Reported Event|Placebo|"Participants will receive either varenicline or placebo~Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks."
210894|NCT01524302|B3|Baseline|Total|Total of all reporting groups
210895|NCT01524302|B2|Baseline|Ceftaroline|"Pharmacodynamics~Ceftaroline: 600 mg Q12h"
210896|NCT01524302|B1|Baseline|Levofloxacin|"Pharmacodynamics~Levofloxacin: 750 mg QD"
210897|NCT01524302|P2|Participant Flow|Ceftaroline|"Pharmacodynamics~Ceftaroline: 600 mg Q12h"
210898|NCT01524302|P1|Participant Flow|Levofloxacin|"Pharmacodynamics~Levofloxacin: 750 mg QD"
210899|NCT01524302|O4|Outcome|Log Inhibition of 4.0mg/L MIC Levofloxacin|Measurement of the decrease in organism (Staphylococcus aureus) colony counts following exposure of serum containing Levofloxacin or Ceftaroline
210900|NCT01524302|O3|Outcome|Log Inhibition of 2.0mg/L MIC Levofloxacin|Measurement of the decrease in organism (Staphylococcus aureus) colony counts following exposure of serum containing Levofloxacin or Ceftaroline
210901|NCT01524302|O2|Outcome|Log Inhibition of 1.0mg/L MIC Levofloxacin|Measurement of the decrease in organism (Staphylococcus aureus) colony counts following exposure of serum containing Levofloxacin or Ceftaroline
210902|NCT01524302|O1|Outcome|Log Inhibition of 0.5mg/L MIC Levofloxacin|Measurement of the decrease in organism (Staphylococcus aureus) colony counts following exposure of serum containing Levofloxacin or Ceftaroline
210903|NCT01524302|O2|Outcome|Ceftaroline|"Pharmacodynamics~Ceftaroline: 600 mg Q12h"
210904|NCT01524302|O1|Outcome|Levofloxacin|"Pharmacodynamics~Levofloxacin: 750 mg QD"
210905|NCT01524302|O2|Outcome|Ceftaroline|"Pharmacodynamics~Ceftaroline: 600 mg Q12h"
210906|NCT01524302|O1|Outcome|Levofloxacin|"Pharmacodynamics~Levofloxacin: 750 mg QD"
210907|NCT01524302|O2|Outcome|Ceftaroline|"Pharmacodynamics~Ceftaroline: 600 mg Q12h"
210908|NCT01524302|O1|Outcome|Levofloxacin|"Pharmacodynamics~Levofloxacin: 750 mg QD"
210909|NCT01524302|O2|Outcome|Ceftaroline|"Pharmacodynamics~Ceftaroline: 600 mg Q12h"
210910|NCT01524302|O1|Outcome|Levofloxacin|"Pharmacodynamics~Levofloxacin: 750 mg QD"
210911|NCT01524302|E2|Reported Event|Ceftaroline|"Pharmacodynamics~Ceftaroline: 600 mg Q12h"
210912|NCT01524302|E1|Reported Event|Levofloxacin|"Pharmacodynamics~Levofloxacin: 750 mg QD"
210913|NCT01524198|B3|Baseline|Total|Total of all reporting groups
210914|NCT01524198|B2|Baseline|Budesonide, Albuterol, Ipratropium Bromide|Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
210915|NCT01524198|B1|Baseline|Normal Saline, Albuterol, Ipratropium Bromide|Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back
210916|NCT01524198|P2|Participant Flow|Budesonide, Albuterol, Ipratropium Bromide|Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
210917|NCT01524198|P1|Participant Flow|Normal Saline, Albuterol, Ipratropium Bromide|Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back
210918|NCT01524198|O2|Outcome|Budesonide, Albuterol, Ipratropium Bromide|Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
210919|NCT01524198|O1|Outcome|Normal Saline, Albuterol, Ipratropium Bromide|Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back
210920|NCT01524198|O2|Outcome|Budesonide, Albuterol, Ipratropium Bromide|Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
210921|NCT01524198|O1|Outcome|Normal Saline, Albuterol, Ipratropium Bromide|Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back
210922|NCT01524198|E2|Reported Event|Budesonide, Albuterol, Ipratropium Bromide|Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
210923|NCT01524198|E1|Reported Event|Normal Saline, Albuterol, Ipratropium Bromide|Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back
210924|NCT01524133|B4|Baseline|Total|Total of all reporting groups
210925|NCT01524133|B3|Baseline|Prolonged Exposure + Placebo (PE/PLB)|"Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo~Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure"
210926|NCT01524133|B2|Baseline|Prolonged Exposure + Sertraline (PE/SERT)|"Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline~Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.~Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure"
210927|NCT01524133|B1|Baseline|Sertraline + Enhanced Medication Management (SERT/EMM)|"24 weeks of sertraline + enhanced medication management~Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8."
210928|NCT01524133|P3|Participant Flow|Prolonged Exposure + Placebo (PE/PLB)|"Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo~Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure"
210929|NCT01524133|P2|Participant Flow|Prolonged Exposure + Sertraline (PE/SERT)|"Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline~Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.~Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure"
210930|NCT01524133|P1|Participant Flow|Sertraline + Enhanced Medication Management (SERT/EMM)|"24 weeks of sertraline + enhanced medication management~Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8."
210931|NCT01524133|O3|Outcome|Prolonged Exposure + Placebo (PE/PLB)|"Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo~Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure"
210932|NCT01524133|O2|Outcome|Prolonged Exposure + Sertraline (PE/SERT)|"Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline~Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.~Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure"
210933|NCT01524133|O1|Outcome|Sertraline + Enhanced Medication Management (SERT/EMM)|"24 weeks of sertraline + enhanced medication management~Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8."
210934|NCT01524133|O3|Outcome|Prolonged Exposure + Placebo (PE/PLB)|"Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo~Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure"
210935|NCT01524133|O2|Outcome|Prolonged Exposure + Sertraline (PE/SERT)|"Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline~Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.~Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure"
210936|NCT01524133|O1|Outcome|Sertraline + Enhanced Medication Management (SERT/EMM)|"24 weeks of sertraline + enhanced medication management~Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8."
210937|NCT01524133|E3|Reported Event|Prolonged Exposure + Placebo (PE/PLB)|"Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo~Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure"
210938|NCT01524133|E2|Reported Event|Prolonged Exposure + Sertraline (PE/SERT)|"Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline~Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.~Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure"
210939|NCT01524133|E1|Reported Event|Sertraline + Enhanced Medication Management (SERT/EMM)|"24 weeks of sertraline + enhanced medication management~Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8."
210940|NCT01523964|B5|Baseline|Total|Total of all reporting groups
210941|NCT01523964|B4|Baseline|Healthy Control Ages 8-12 Inclusive|
210942|NCT01523964|B3|Baseline|Healthy Control Ages 3-7 Inclusive|
210943|NCT01523964|B2|Baseline|DMD Subject Ages 8-12 Inclusive|
210944|NCT01523964|B1|Baseline|DMD Subject Ages 3-7 Inclusive|
210945|NCT01523964|P4|Participant Flow|Healthy Control Ages 8-12 Inclusive|
210946|NCT01523964|P3|Participant Flow|Healthy Control Ages 3-7 Inclusive|
210947|NCT01523964|P2|Participant Flow|DMD Subject Ages 8-12 Inclusive|
210948|NCT01523964|P1|Participant Flow|DMD Subject Ages 3-7 Inclusive|
210949|NCT01523964|O4|Outcome|Healthy Control Ages 8-12 Inclusive|
210950|NCT01523964|O3|Outcome|Healthy Control Ages 3-7 Inclusive|
210951|NCT01523964|O2|Outcome|DMD Subject Ages 8-12 Inclusive|
210952|NCT01523964|O1|Outcome|DMD Subject Ages 3-7 Inclusive|
210953|NCT01523964|E4|Reported Event|Healthy Control Ages 8-12 Inclusive|
210954|NCT01523964|E3|Reported Event|Healthy Control Ages 3-7 Inclusive|
210955|NCT01523964|E2|Reported Event|DMD Subject Ages 8-12 Inclusive|
210956|NCT01523964|E1|Reported Event|DMD Subject Ages 3-7 Inclusive|
210957|NCT01523899|B3|Baseline|Total|Total of all reporting groups
210958|NCT01523899|B2|Baseline|Standard Culture|Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay
210959|NCT01523899|B1|Baseline|Xpert MRSA/SA SSTI|Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay
210960|NCT01523899|P2|Participant Flow|Standard Culture|Standard bacterial culture and susceptibility testing
210961|NCT01523899|P1|Participant Flow|Xpert MRSA/SA SSTI|Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay
210962|NCT01523899|O2|Outcome|Standard Culture|Standard bacterial culture and susceptibility testing
210963|NCT01523899|O1|Outcome|Xpert MRSA/SA SSTI|Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay
210964|NCT01523899|O2|Outcome|Standard Culture|Standard bacterial culture and susceptibility testing
210965|NCT01523899|O1|Outcome|Xpert MRSA/SA SSTI|Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay
210966|NCT01523899|O2|Outcome|Standard Culture|Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay
210967|NCT01523899|O1|Outcome|Xpert MRSA/SA SSTI|Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay
210968|NCT01523899|E2|Reported Event|Standard Culture|Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay
210969|NCT01523899|E1|Reported Event|Xpert MRSA/SA SSTI|Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay
210970|NCT01523886|B3|Baseline|Total|Total of all reporting groups
210971|NCT01523886|B2|Baseline|Moderate Neuromuscular Blockade|Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
210972|NCT01523886|B1|Baseline|Deep Neuromuscular Blockade|Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h
210973|NCT01523886|P2|Participant Flow|Moderate Neuromuscular Blockade|Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
210974|NCT01523886|P1|Participant Flow|Deep Neuromuscular Blockade|Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h
210975|NCT01523886|O2|Outcome|Moderate Neuromuscular Blockade|Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
210979|NCT01523873|B1|Baseline|All Included Patients|All patients scheduled for a Dotarem-enhanced MRI with appropriate consent, prospectively enrolled in the study and having reliable data reported.
210980|NCT01523873|P1|Participant Flow|All Included Patients|All patients scheduled for a Dotarem-enhanced MRI with appropriate consent, prospectively enrolled in the study and having reliable data reported.
210981|NCT01523873|O1|Outcome|Efficacy Population|Efficacy Population included all patients administered with Dotarem who have been imaged and have had a valid diagnostic assessment.
210982|NCT01523873|O1|Outcome|Efficacy Population|Efficacy Population included all patients administered with Dotarem who have been imaged and have had a valid diagnostic assessment.
210983|NCT01523873|O1|Outcome|Patients With Moderate to Severe Impaired Renal Function|Patients identified with moderate to severe impaired renal function at the time of inclusion (i.e. estimated Glomerular Filtration Rate (eGFR) or estimated creatinine clearance (eCrCl) <60 ml/min (1.73 m2))
210984|NCT01523873|O1|Outcome|Safety Population|Safety Population included All Included Patients administered with Dotarem.
210985|NCT01523873|E1|Reported Event|Safety Population|Safety Population included All Included Patients administered with Dotarem.
210986|NCT01523756|B1|Baseline|Overall Study|
210987|NCT01523756|P2|Participant Flow|Own Product (Baseline) - Test Product 2 - Test Product 1|"own product (baseline) - test product 2 - test product 1~test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2"
210988|NCT01523756|P1|Participant Flow|Own Product (Baseline) - Test Product 1 - Test Product 2|"own product (baseline) - test product 1 - test product 2~test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1"
210989|NCT01523756|O3|Outcome|Baseline|"Data collected on own product-~All subjects collected baseline data on own product in the first period."
210990|NCT01523756|O2|Outcome|Test Product 2|"own product (baseline) - test product 2 - test product 1~test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2"
210991|NCT01523756|O1|Outcome|Test Product 1|"own product (baseline) - test product 1 - test product 2~test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1"
210992|NCT01523756|E3|Reported Event|Baseline|"Data collected on own product-~All subjects collected baseline data on own product in the first period."
210993|NCT01523756|E2|Reported Event|Test Product 2|"own product (baseline) - test product 2 - test product 1~test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2"
210994|NCT01523756|E1|Reported Event|Test Product 1|"own product (baseline) - test product 1 - test product 2~test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1"
210995|NCT01523743|B1|Baseline|All Study Participants|"125 subjects were randomized in this study, however 7 subjects discontinued only providing baseline data and were therefore excluded from the ITT population as they did not contribute with any endpoint data.~The baseline and analysis data are based on the ITT population."
210996|NCT01523743|P2|Participant Flow|First Standard Care; Then Compact Catheter|First period: Standard Care: Coated intermittent catheter normally used by subject Second period: Compact catheter: Compact intermittent catheter from Coloplast
210997|NCT01523743|P1|Participant Flow|First Compact Catheter, Then Standard Care|First period: Compact intermittent catheter from Coloplast. Second period: Standard Care: Coated intermittent catheter normally used by subject
210998|NCT01523743|O2|Outcome|Standard Care|Standard Care: Coated intermittent catheter normally used by subject
210999|NCT01523743|O1|Outcome|Compact Catheter|Compact intermittent catheter
211000|NCT01523743|E2|Reported Event|Standard Care|Standard Care: Coated intermittent catheter normally used by subject
211001|NCT01523743|E1|Reported Event|Compact Catheter|Compact intermittent catheter
211002|NCT01523613|B4|Baseline|Total|Total of all reporting groups
211003|NCT01523613|B3|Baseline|Paired Restorations (1R and 1F)|"While this is not truly a separate arm for outcome analysis, this arm represents those individuals who had paired restorations, one of each: 1 ChemFil Rock restorative and 1 Fuji IX GP restorative."
211004|NCT01523613|B2|Baseline|Fuji IX Restoration (F-single)|Dental restoration made of Fuji IX GP Extra, a high-viscous glassionomer restorative used as posterior dental filling material (using Cavity Conditioner and GC-Coat Plus).
211005|NCT01523613|B1|Baseline|ChemFil Rock Restoration (R-single)|Dental restoration made of ChemFil Rock, a high-viscous glassionomer restorative used as posterior dental filling material (no cavity conditioning, no coating of finished restoration)
211006|NCT01523613|P3|Participant Flow|Paired Restorations (Rock + Fuji)|"While this is not truly a separate arm for outcome analysis, this arm represents those individuals who had paired restorations, one of each: 1 ChemFil Rock restorative and 1 Fuji IX GP restorative."
211007|NCT01523613|P2|Participant Flow|Fuji IX Restoration (F)|Dental restoration made of Fuji IX GP Extra, a high-viscous glassionomer restorative used as posterior dental filling material (using Cavity Conditioner and GC-Coat Plus).
211008|NCT01523613|P1|Participant Flow|ChemFil Rock Restoration (R)|Dental restoration made of ChemFil Rock, a high-viscous glassionomer restorative used as posterior dental filling material (no cavity conditioning, no coating of finished restoration)
211009|NCT01523613|O2|Outcome|Fuji-restored Tooth (F-tooth)|Tooth restored with a Fuji IX GP Extra filling.
211010|NCT01523613|O1|Outcome|Rock-restored Tooth (R-tooth)|Tooth restored with a ChemFil Rock filling.
211011|NCT01523613|O2|Outcome|Fuji IX Restoration (F)|Dental restoration made of Fuji IX GP Extra, used with Cavity Conditioner and application of GC-Coat Plus
211012|NCT01523613|O1|Outcome|ChemFil Rock Restoration (R)|Dental restoration made of ChemFil Rock, a high-viscous glassionomer restorative used as posterior dental filling material (no cavity conditioning, no coating of finished restoration)
211013|NCT01523613|O2|Outcome|Fuji IX Restoration (F)|Dental restoration made of Fuji IX GP Extra, used with Cavity Conditioner and application of GC-Coat Plus
211014|NCT01523613|O1|Outcome|ChemFil Rock Restoration (R)|Dental restoration made of ChemFil Rock, a high-viscous glassionomer restorative used as posterior dental filling material (no cavity conditioning, no coating of finished restoration)
211015|NCT01523613|E2|Reported Event|Fuji-restored (F-tooth)|Tooth restored with a Fuji IX GP Extra filling.
211016|NCT01523613|E1|Reported Event|Rock-restored Tooth (R-tooth)|Tooth restored with a ChemFil Rock filling.
211017|NCT01523587|B3|Baseline|Total|Total of all reporting groups
211018|NCT01523587|B2|Baseline|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
211019|NCT01523587|B1|Baseline|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
211020|NCT01523587|P2|Participant Flow|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
211021|NCT01523587|P1|Participant Flow|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
211022|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
211023|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
211024|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
211025|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
211026|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
211027|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
211028|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
211029|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
211030|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
211031|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
211032|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
211033|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
211034|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
211035|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
211036|NCT01523587|E2|Reported Event|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
211037|NCT01523587|E1|Reported Event|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
211038|NCT01523496|B5|Baseline|Total|Total of all reporting groups
211039|NCT01523496|B4|Baseline|HIV - With Vitamin D Control Dose|HIV uninfected controls receiving Vitamin D low dose: 18,000 IU per month
211040|NCT01523496|B3|Baseline|HIV - With Vitamin D Supplementation|HIV-uninfected adults who were supplemented with vitamin D: a medium dose of 60,000 IU per month or a higher dose of 120,000 IU/month.
211041|NCT01523496|B2|Baseline|HIV+ Young Adults With Vitamin D Control Dose|HIV+ receiving Vitamin D low dose: 18,000 IU per month
211042|NCT01523496|B1|Baseline|HIV+ With Vit D Supplementation|HIV-infected adults who were supplemented with vit D ( medium dose: 60,000 IU per month or vitamin D high dose: 120,000 IU/month ) were combined into the supplementation group and compared to the standard control vitamin D dose
211043|NCT01523496|P4|Participant Flow|HIV - With Vitamin D Control Dose|HIV uninfected controls receiving Vitamin D low dose: 18,000 IU per month
211044|NCT01523496|P3|Participant Flow|HIV - With Vitamin D Supplementation|HIV-uninfected adults who were supplemented with vitamin D: a medium dose of 60,000 IU per month or a higher dose of 120,000 IU/month.
211045|NCT01523496|P2|Participant Flow|HIV+ Young Adults With Vitamin D Control Dose|HIV+ receiving Vitamin D low dose: 18,000 IU per month
211046|NCT01523496|P1|Participant Flow|HIV+ With Vit D Supplementation|HIV-infected adults who were supplemented with vit D ( medium dose: 60,000 IU per month or vitamin D high dose: 120,000 IU/month ) were combined into the supplementation group and compared to the standard control vitamin D dose
211047|NCT01523496|O4|Outcome|HIV Negative on Vit D Supplementation Dose|HIV negative controls on vitamin D supplementation: medium dose of 60,000 IU per month or higher dose of 120,000 IU/month
211048|NCT01523496|O3|Outcome|HIV Negative on Vit D Control Dose|HIV negative controls on Vitamin D low dose: 18,000 IU per month
211049|NCT01523496|O2|Outcome|HIV + on Vit D Supplementation Dose|HIV+ receiving Vitamin D supplementation (medium dose: 60,000 IU per month or higher dose: 120,000 IU/month)
211050|NCT01523496|O1|Outcome|HIV + on Vitamin D Control Dose|HIV+ receiving vitamin D low dose: 18,000 IU per month
211051|NCT01523496|O4|Outcome|HIV Negative on Vitamin D Supplementation Dose|HIV negative controls receiving Vitamin D medium dose: 60,000 IU per month or vitamin D high dose: 120,000 IU/month
211052|NCT01523496|O3|Outcome|HIV Negative on Vitamin D Control Dose|HIV negative controls receiving Vitamin D low dose: 18,000 IU per month
211053|NCT01523496|O2|Outcome|HIV Positive on Vit D Supplementation Dose|HIV-infected young adults receiving a supplementation dose of vitamin D (either medium dose of 60,000 IU per month or a high dose of 120,000 IU/month)
211054|NCT01523496|O1|Outcome|HIV Positive on Vit D Control Dose|HIV+ receiving low vitamin D dose 18,000 IU per month
211055|NCT01523496|E4|Reported Event|HIV- on Vitamin D Supplementation Dose|HIV negative patients receiving vitamin D supplementation doses (medium dose of 60,000 IU per month or higher dose of 120,000 IU/month)
211056|NCT01523496|E3|Reported Event|HIV - on Vitamin D Control Dose|HIV negative patients receiving vitamin D control dose (low dose of 18,000 IU per month)
211057|NCT01523496|E2|Reported Event|HIV+ on Vitamin D Supplementation Dose|HIV+ receiving vitamin D supplementation doses (medium dose of 60,000 IU per month or higher dose of 120,000 IU/month)
211058|NCT01523496|E1|Reported Event|HIV + on Vitamin D Control Dose|HIV+ receiving vitamin D control dose ( low dose: 18,000 IU per month)
211059|NCT01523457|B3|Baseline|Total|Total of all reporting groups
211060|NCT01523457|B2|Baseline|LAPC Modified FOLFIRINOX|Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
211061|NCT01523457|B1|Baseline|MPC Modified FOLFIRINOX|Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
211062|NCT01523457|P2|Participant Flow|LAPC Modified FOLFIRINOX|Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
211063|NCT01523457|P1|Participant Flow|MPC Modified FOLFIRINOX|Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
211064|NCT01523457|O2|Outcome|LAPC Modified FOLFIRINOX|Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
211065|NCT01523457|O1|Outcome|MPC Modified FOLFIRINOX|Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
211066|NCT01523457|O2|Outcome|LAPC Modified FOLFIRINOX|Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
213261|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
211067|NCT01523457|O1|Outcome|MPC Modified FOLFIRINOX|Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
211068|NCT01523457|O2|Outcome|LAPC Modified FOLFIRINOX|Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
211069|NCT01523457|O1|Outcome|MPC Modified FOLFIRINOX|Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
211070|NCT01523457|O2|Outcome|LAPC Modified FOLFIRINOX|Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
211071|NCT01523457|O1|Outcome|MPC Modified FOLFIRINOX|Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
211072|NCT01523457|O2|Outcome|LAPC Modified FOLFIRINOX|Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
211073|NCT01523457|O1|Outcome|MPC Modified FOLFIRINOX|Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
211074|NCT01523457|O2|Outcome|LAPC Modified FOLFIRINOX|Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
211075|NCT01523457|O1|Outcome|MPC Modified FOLFIRINOX|Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
211076|NCT01523457|E2|Reported Event|LAPC Modified FOLFIRINOX|Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
211130|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
211198|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
211077|NCT01523457|E1|Reported Event|MPC Modified FOLFIRINOX|Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
211078|NCT01523392|B3|Baseline|Total|Total of all reporting groups
211079|NCT01523392|B2|Baseline|Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), and then ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days (Period 2)
211080|NCT01523392|B1|Baseline|Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 2)
211081|NCT01523392|P2|Participant Flow|Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), and then ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days (Period 2)
211082|NCT01523392|P1|Participant Flow|Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence|Ticagrelor 180 milligrams (mg) loading dose followed by 90 mg twice daily (bd) for 7, 8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 7, 8 or 9 days (Period 2)
211083|NCT01523392|O2|Outcome|Ticagrelor (Treatment Period 2)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
211084|NCT01523392|O1|Outcome|Ticagrelor (Treatment Period 1)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
211085|NCT01523392|O2|Outcome|Ticagrelor (Treatment Period 2)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
211086|NCT01523392|O1|Outcome|Ticagrelor (Treatment Period 1)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
211087|NCT01523392|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days
211088|NCT01523392|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
211089|NCT01523392|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days
211090|NCT01523392|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
211091|NCT01523392|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days
211092|NCT01523392|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
211093|NCT01523392|E2|Reported Event|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days
211094|NCT01523392|E1|Reported Event|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
211095|NCT01523366|B3|Baseline|Total|Total of all reporting groups
211096|NCT01523366|B2|Baseline|Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), then ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days (Period 2)
211097|NCT01523366|B1|Baseline|Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence|Ticagrelor 180 milligrams (mg) loading dose followed by 90 mg twice daily (bd) for 7,8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 7, 8 or 9 days (Period 2).
211098|NCT01523366|P2|Participant Flow|Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), then ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days (Period 2)
211099|NCT01523366|P1|Participant Flow|Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence|Ticagrelor 180 milligrams (mg) loading dose followed by 90 mg twice daily (bd) for 7,8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 7, 8 or 9 days (Period 2).
211100|NCT01523366|O2|Outcome|Ticagrelor (Treatment Period 2)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
211101|NCT01523366|O1|Outcome|Ticagrelor (Treatment Period 1)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
211102|NCT01523366|O2|Outcome|Ticagrelor (Treatment Period 2)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
211103|NCT01523366|O1|Outcome|Ticagrelor (Treatment Period 1)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
211104|NCT01523366|O2|Outcome|Clopidogrel Arm|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.
211105|NCT01523366|O1|Outcome|Ticagrelor Arm|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.
211106|NCT01523366|O2|Outcome|Clopidogrel Arm|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.
211107|NCT01523366|O1|Outcome|Ticagrelor Arm|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.
211108|NCT01523366|O2|Outcome|Clopidogrel Arm|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.
211109|NCT01523366|O1|Outcome|Ticagrelor Arm|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.
211110|NCT01523366|E2|Reported Event|Clopidogrel Arm|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.
211111|NCT01523366|E1|Reported Event|Ticagrelor Arm|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.
211112|NCT01523301|B3|Baseline|Total Title|
211113|NCT01523301|B2|Baseline|Placebo|"Placebo, daily doses, placebo Group. Subjects randomized to placebo received matching placebo patches.~Early-stage Parkinson´s disease for 1 week: Placebo patches´ dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Placebo patches´dose at 4 mg/24 h.~Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.~All subjects remained 8-weeks in the Maintenance Period.~In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.~A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
211114|NCT01523301|B1|Baseline|Rotigotine|"Rotigotine, daily doses, treatment Group.~Early-stage Parkinon´s disease for 1 week: Rotigotine dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Rotigotine dose at 4 mg/24 h.~Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.~All subjects remained 8-weeks in the Maintenance Period. In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.~A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
211115|NCT01523301|P2|Participant Flow|Placebo|"Placebo, daily doses, placebo Group. Subjects randomized to placebo received matching placebo patches.~Early-stage Parkinson´s disease for 1 week: Placebo patches´ dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Placebo patches´dose at 4 mg/24 h.~Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.~All subjects remained 8-weeks in the Maintenance Period.~In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.~A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
211116|NCT01523301|P1|Participant Flow|Rotigotine|"Rotigotine, daily doses, treatment Group.~Early-stage Parkinon´s disease for 1 week: Rotigotine dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Rotigotine dose at 4 mg/24 h.~Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.~All subjects remained 8-weeks in the Maintenance Period. In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.~A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
211117|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
211118|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
211119|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
211120|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
211121|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
211122|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
211123|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
211124|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
211125|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
211126|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
211127|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
211128|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
211129|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
211153|NCT01522976|O2|Outcome|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV"
211131|NCT01523301|E2|Reported Event|Placebo|"Placebo, daily doses, placebo Group. Subjects randomized to placebo received matching placebo patches.~Early-stage Parkinson´s disease for 1 week: Placebo patches´ dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Placebo patches´dose at 4 mg/24 h.~Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.~All subjects remained 8-weeks in the Maintenance Period.~In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.~A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
211132|NCT01523301|E1|Reported Event|Rotigotine|"Rotigotine, daily doses, treatment Group.~Early-stage Parkinon´s disease for 1 week: Rotigotine dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Rotigotine dose at 4 mg/24 h.~Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.~All subjects remained 8-weeks in the Maintenance Period. In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.~A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
211133|NCT01522976|B4|Baseline|Total|Total of all reporting groups
211134|NCT01522976|B3|Baseline|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Vorinostat: Given PO"
211135|NCT01522976|B2|Baseline|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV"
211136|NCT01522976|B1|Baseline|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Lenalidomide: Given PO"
211137|NCT01522976|P3|Participant Flow|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Vorinostat: Given PO"
211138|NCT01522976|P2|Participant Flow|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV"
211139|NCT01522976|P1|Participant Flow|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Lenalidomide: Given PO"
211140|NCT01522976|O3|Outcome|Arm 3: Azacitidine/Vorinostat|Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO
211141|NCT01522976|O2|Outcome|Arm 2: Azacitidine|Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
211142|NCT01522976|O1|Outcome|Arm 1: Azacitidine/Lenalidomide|Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
211143|NCT01522976|O3|Outcome|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Vorinostat: Given PO"
211144|NCT01522976|O2|Outcome|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV"
211145|NCT01522976|O1|Outcome|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Lenalidomide: Given PO"
211146|NCT01522976|O3|Outcome|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Vorinostat: Given PO"
211147|NCT01522976|O2|Outcome|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV"
211148|NCT01522976|O1|Outcome|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Lenalidomide: Given PO"
211149|NCT01522976|O3|Outcome|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Vorinostat: Given PO"
211150|NCT01522976|O2|Outcome|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV"
211151|NCT01522976|O1|Outcome|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Lenalidomide: Given PO"
211152|NCT01522976|O3|Outcome|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Vorinostat: Given PO"
213262|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
211154|NCT01522976|O1|Outcome|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Lenalidomide: Given PO"
211155|NCT01522976|O3|Outcome|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Vorinostat: Given PO"
211156|NCT01522976|O2|Outcome|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV"
211157|NCT01522976|O1|Outcome|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Lenalidomide: Given PO"
211158|NCT01522976|E3|Reported Event|Arm 3: Azacitidine/Vorinostat|Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO
211159|NCT01522976|E2|Reported Event|Arm 2: Azacitidine|Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
211160|NCT01522976|E1|Reported Event|Arm 1: Azacitidine/Lenalidomide|Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Lenalidomide: Given PO
211161|NCT01522963|B5|Baseline|Total|Total of all reporting groups
211162|NCT01522963|B4|Baseline|Nicotine Lozenge 30 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 30 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
211163|NCT01522963|B3|Baseline|Nicotine Lozenge 20 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 20 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
211164|NCT01522963|B2|Baseline|Nicotine Lozenge 10 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 10 minutes prior to the stress task at one laboratory session and after the stress task at the other laboratory session
211165|NCT01522963|B1|Baseline|Nicotine Lozenge Immediately Prior to Stress Task.|Subjects receive the 4 mg nicotine lozenge immediately prior to the stress task at one laboratory session and after the stress task at the other laboratory session
211166|NCT01522963|P4|Participant Flow|Nicotine Lozenge 30 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 30 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
211167|NCT01522963|P3|Participant Flow|Nicotine Lozenge 20 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 20 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
211168|NCT01522963|P2|Participant Flow|Nicotine Lozenge 10 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 10 minutes prior to the stress task at one laboratory session and after the stress task at the other laboratory session
211169|NCT01522963|P1|Participant Flow|Nicotine Lozenge Immediately Prior to Stress Task.|Subjects receive the 4 mg nicotine lozenge immediately prior to the stress task at one laboratory session and after the stress task at the other laboratory session
211170|NCT01522963|O4|Outcome|Nicotine Lozenge 30 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 30 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
211171|NCT01522963|O3|Outcome|Nicotine Lozenge 20 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 20 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
211172|NCT01522963|O2|Outcome|Nicotine Lozenge 10 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 10 minutes prior to the stress task at one laboratory session and after the stress task at the other laboratory session
211173|NCT01522963|O1|Outcome|Nicotine Lozenge Immediately Prior to Stress Task.|Subjects receive the 4 mg nicotine lozenge immediately prior to the stress task at one laboratory session and after the stress task at the other laboratory session
211174|NCT01522963|O4|Outcome|Nicotine Lozenge 30 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 30 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
211175|NCT01522963|O3|Outcome|Nicotine Lozenge 20 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 20 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
211176|NCT01522963|O2|Outcome|Nicotine Lozenge 10 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 10 minutes prior to the stress task at one laboratory session and after the stress task at the other laboratory session
211177|NCT01522963|O1|Outcome|Nicotine Lozenge Immediately Prior to Stress Task.|Subjects receive the 4 mg nicotine lozenge immediately prior to the stress task at one laboratory session and after the stress task at the other laboratory session
211178|NCT01522963|E2|Reported Event|Nicotine Lozenge After Stress Task|"Subjects will receive the nicotine lozenge after the stress task during the first laboratory session and prior to the stress task at the second laboratory session~Nicotine lozenge 4 mg: A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task"
211179|NCT01522963|E1|Reported Event|Nicotine Lozenge Prior to Stress Task|"Subjects will receive the nicotine lozenge at one of four time-points prior to the stress task at the first laboratory session and after the stress task at the second laboratory session~Nicotine lozenge 4 mg: A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task"
211196|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
211197|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
211180|NCT01522937|B1|Baseline|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).~individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
211181|NCT01522937|P1|Participant Flow|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).~individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
211182|NCT01522937|O1|Outcome|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).~individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
211183|NCT01522937|O1|Outcome|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).~individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
211184|NCT01522937|O1|Outcome|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).~individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
211185|NCT01522937|O1|Outcome|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).~individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
211186|NCT01522937|O1|Outcome|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).~individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
211187|NCT01522937|E1|Reported Event|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).~individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
211188|NCT01522924|B3|Baseline|Total|Total of all reporting groups
211189|NCT01522924|B2|Baseline|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
211190|NCT01522924|B1|Baseline|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
211191|NCT01522924|P2|Participant Flow|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
211192|NCT01522924|P1|Participant Flow|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
211193|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
211194|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
211195|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
211199|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
211200|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
211201|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
211202|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
211203|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
211204|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
211205|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
211206|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
211207|NCT01522924|E2|Reported Event|Counseling/Debriefing|participated in counseling and debriefing sessions
211208|NCT01522924|E1|Reported Event|Lecture Only|participated in lecture only
211209|NCT01522703|B3|Baseline|Total|Total of all reporting groups
211210|NCT01522703|B2|Baseline|Alfalfa Sprouts (Placebo Control)|
211211|NCT01522703|B1|Baseline|Broccoli Sprouts|
211212|NCT01522703|P2|Participant Flow|Alfalfa Sprouts (Placebo Control)|ingestion of alfalfa sprouts 3 consecutive days
211213|NCT01522703|P1|Participant Flow|Broccoli Sprouts|ingestion of broccoli sprouts 3 consecutive days
211214|NCT01522703|O2|Outcome|Broccoli Sprouts|ingestion of broccoli sprouts for 3 consecutive days
211215|NCT01522703|O1|Outcome|Alfalfa Sprouts (Placebo Control)|ingestion of alfalfa sprouts for 3 consecutive days
211216|NCT01522703|E2|Reported Event|Alfalfa Sprouts (Placebo Control)|
211217|NCT01522703|E1|Reported Event|Broccoli Sprouts|
211218|NCT01522456|B1|Baseline|Total Participants|All subjects randomized into the trial who received Epiduo Gel and Retin-A Micro 0.1% gel on each side of the face
211219|NCT01522456|P1|Participant Flow|Total Participants|All subjects randomized into the trial who received Epiduo Gel and Retin-A Micro 0.1% gel on each side of the face
211220|NCT01522456|O4|Outcome|Retin-A Micro (Fitzpatrick Skin Types IV-VI)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211221|NCT01522456|O3|Outcome|Epiduo Gel (Fitzpatrick Skin Types IV-VI)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211222|NCT01522456|O2|Outcome|Retin-A Micro (Fitzpatrick Skin Types I-III)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211223|NCT01522456|O1|Outcome|Epiduo Gel (Fitzpatrick Skin Types I-III)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211224|NCT01522456|O4|Outcome|Retin-A Micro (Fitzpatrick Skin Types IV-VI)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211225|NCT01522456|O3|Outcome|Epiduo Gel (Fitzpatrick Skin Types IV-VI)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211226|NCT01522456|O2|Outcome|Retin-A Micro (Fitzpatrick Skin Types I-III)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211227|NCT01522456|O1|Outcome|Epiduo Gel (Fitzpatrick Skin Types I-III)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211228|NCT01522456|O4|Outcome|Retin-A Micro (Fitzpatrick Skin Types IV-VI)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211229|NCT01522456|O3|Outcome|Epiduo Gel (Fitzpatrick Skin Types IV-VI)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211230|NCT01522456|O2|Outcome|Retin-A Micro (Fitzpatrick Skin Types I-III)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211231|NCT01522456|O1|Outcome|Epiduo Gel (Fitzpatrick Skin Types I-III)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211232|NCT01522456|O4|Outcome|Retin-A Micro (Fitzpatrick Skin Types IV-VI)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211233|NCT01522456|O3|Outcome|Epiduo Gel (Fitzpatrick Skin Types IV-VI)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211234|NCT01522456|O2|Outcome|Retin-A Micro (Fitzpatrick Skin Types I-III)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211235|NCT01522456|O1|Outcome|Epiduo Gel (Fitzpatrick Skin Types I-III)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211236|NCT01522456|O4|Outcome|Retin-A Micro (Fitzpatrick Skin Types IV-VI)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
213769|NCT01514357|O2|Outcome|Placebo|Subjects will receive SQ placebo bid for seven consecutive days.
211237|NCT01522456|O3|Outcome|Epiduo Gel (Fitzpatrick Skin Types IV-VI)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211238|NCT01522456|O2|Outcome|Retin-A Micro (Fitzpatrick Skin Types I-III)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211239|NCT01522456|O1|Outcome|Epiduo Gel (Fitzpatrick Skin Types I-III)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211240|NCT01522456|O4|Outcome|Retin-A Micro (Fitzpatrick Skin Types IV-VI)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211241|NCT01522456|O3|Outcome|Epiduo Gel (Fitzpatrick Skin Types IV-VI)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211242|NCT01522456|O2|Outcome|Retin-A Micro (Fitzpatrick Skin Types I-III)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211243|NCT01522456|O1|Outcome|Epiduo Gel (Fitzpatrick Skin Types I-III)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211244|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211245|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211246|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211247|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211248|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211249|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211250|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211251|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211252|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211253|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211254|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211255|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211256|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211257|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211258|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211259|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211260|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211261|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211262|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211263|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211264|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211265|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211266|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211267|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211268|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211269|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211270|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211271|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211272|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211273|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211274|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211275|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211276|NCT01522456|E3|Reported Event|Non-application Site|Adverse events occurring on non-application sites
211277|NCT01522456|E2|Reported Event|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
211278|NCT01522456|E1|Reported Event|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
211279|NCT01522443|B3|Baseline|Total|Total of all reporting groups
211280|NCT01522443|B2|Baseline|Mitoxantrone/Prednisone|"Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.~Mitoxantrone (12mg/m^2) given by IV once every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily."
211281|NCT01522443|B1|Baseline|Cabozantinib|"Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.~Cabozantinib (XL184) 60 mg tablets taken orally once daily and mitoxantrone-matched placebo infusion every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily."
211282|NCT01522443|P2|Participant Flow|Mitoxantrone/Prednisone|"Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.~Mitoxantrone (12mg/m^2) given by IV once every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily."
211283|NCT01522443|P1|Participant Flow|Cabozantinib|"Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.~Cabozantinib (XL184) 60 mg tablets taken orally once daily and mitoxantrone-matched placebo infusion every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily."
211284|NCT01522443|O2|Outcome|Mitoxantrone/Prednisone|"Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.~Mitoxantrone (12mg/m^2) given by IV once every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily."
211285|NCT01522443|O1|Outcome|Cabozantinib|"Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.~Cabozantinib (XL184) 60 mg tablets taken orally once daily and mitoxantrone-matched placebo infusion every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily."
211286|NCT01522443|O2|Outcome|Mitoxantrone/Prednisone|"Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.~Mitoxantrone (12mg/m^2) given by IV once every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily."
211287|NCT01522443|O1|Outcome|Cabozantinib|"Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.~Cabozantinib (XL184) 60 mg tablets taken orally once daily and mitoxantrone-matched placebo infusion every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily."
211288|NCT01522443|O2|Outcome|Mitoxantrone/Prednisone|"Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.~Mitoxantrone (12mg/m^2) given by IV once every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily."
211289|NCT01522443|O1|Outcome|Cabozantinib|"Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.~Cabozantinib (XL184) 60 mg tablets taken orally once daily and mitoxantrone-matched placebo infusion every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily."
211290|NCT01522443|E2|Reported Event|Mitoxantrone/Prednisone|"Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.~Mitoxantrone (12mg/m^2) given by IV once every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily."
211291|NCT01522443|E1|Reported Event|Cabozantinib|"Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.~Cabozantinib (XL184) 60 mg tablets taken orally once daily and mitoxantrone-matched placebo infusion every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily."
211292|NCT01522339|B1|Baseline|Pilot Group|Patients who had an MRI in the NICU scanner.
211293|NCT01522339|P1|Participant Flow|Pilot Group|Patients who received an MRI.
211294|NCT01522339|O1|Outcome|Pilot Group|Patients who had an MRI on the NICU scanner.
211295|NCT01522339|O1|Outcome|Pilot Group|Patients who received an MRI on the NICU scanner.
211296|NCT01522339|E1|Reported Event|Pilot Group|Patients who had an MRI in the NICU scanner.
211297|NCT01522235|B3|Baseline|Total|Total of all reporting groups
211298|NCT01522235|B2|Baseline|Group B|"Placebo~2 treatments of placebo and 2 treatments of IVIg: Participants will receive placebo (5% albumin) at 2.0 gm/kg over 2-4 consecutive days. A maintenance treatment with placebo (5% albumin) at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.~They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
211342|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211299|NCT01522235|B1|Baseline|Group A|"IVIg~IVIG: Participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment IVIg, at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.~They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
211300|NCT01522235|P2|Participant Flow|Placebo Group|"Placebo~2 treatments of placebo and 2 treatments of IVIg: Participants will receive placebo (5% albumin) at 2.0 gm/kg over 2-4 consecutive days. A maintenance treatment with placebo (5% albumin) at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period."
211301|NCT01522235|P1|Participant Flow|IVIG Group|"IVIg~IVIg: Participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment IVIg, at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period."
211302|NCT01522235|O2|Outcome|Group B|"Placebo~2 treatments of placebo and 2 treatments of IVIg: Participants will receive placebo (5% albumin) at 2.0 gm/kg over 2-4 consecutive days. A maintenance treatment with placebo (5% albumin) at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.~They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
211303|NCT01522235|O1|Outcome|Group A|"IVIg~IVIg: Participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment IVIg, at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.~They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
211304|NCT01522235|O2|Outcome|Placebo Group|"Placebo~2 treatments of placebo and 2 treatments of IVIg: Participants will receive placebo (5% albumin) at 2.0 gm/kg over 2-4 consecutive days. A maintenance treatment with placebo (5% albumin) at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.~They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
211305|NCT01522235|O1|Outcome|IVIg Group|"IVIg~IVIg: Participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment IVIg, at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.~They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
211306|NCT01522235|O2|Outcome|Placebo Group|"Placebo~2 treatments of placebo and 2 treatments of IVIg: Participants will receive placebo (5% albumin) at 2.0 gm/kg over 2-4 consecutive days. A maintenance treatment with placebo (5% albumin) at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.~They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
211307|NCT01522235|O1|Outcome|IVIg Group|"IVIg~IVIg: Participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment IVIg, at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.~They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
211308|NCT01522235|O2|Outcome|Placebo Group|"Placebo~2 treatments of placebo and 2 treatments of IVIg: Participants will receive placebo (5% albumin) at 2.0 gm/kg over 2-4 consecutive days. A maintenance treatment with placebo (5% albumin) at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.~They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
211309|NCT01522235|O1|Outcome|IVIg Group|"IVIg~IVIg: Participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment IVIg, at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.~They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
211310|NCT01522235|O2|Outcome|Placebo Group|"Placebo~2 treatments of placebo and 2 treatments of IVIg: Participants will receive placebo (5% albumin) at 2.0 gm/kg over 2-4 consecutive days. A maintenance treatment with placebo (5% albumin) at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.~They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
211311|NCT01522235|O1|Outcome|IVIG Group|"IVIg~IVIg: Participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment IVIg, at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.~They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
211312|NCT01522235|O2|Outcome|Placebo Group|"Placebo~2 treatments of placebo and 2 treatments of IVIG: Participants will receive placebo (5% albumin) at 2.0 gm/kg over 2-4 consecutive days. A maintenance treatment with placebo (5% albumin) at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.~They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
211340|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211313|NCT01522235|O1|Outcome|IVIg Group|"IVIg~IVIg: Participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment IVIg, at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.~They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
211314|NCT01522235|E2|Reported Event|Placebo Group|"Placebo~2 treatments of placebo and 2 treatments of IVIg: Participants will receive placebo (5% albumin) at 2.0 gm/kg over 2-4 consecutive days. A maintenance treatment with placebo (5% albumin) at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.~They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
211315|NCT01522235|E1|Reported Event|IVIg Group|"IVIg~IVIg: Participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment IVIg, at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.~They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
211316|NCT01522131|B3|Baseline|Total|Total of all reporting groups
211317|NCT01522131|B2|Baseline|Laser With Bioresorabable Membrane (Test)|bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
211318|NCT01522131|B1|Baseline|Bioresorbable Membrane Will be Used as the Control|"Bioresorbable membrane (control)~bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)"
211319|NCT01522131|P2|Participant Flow|Laser With Bioresorabable Membrane (Test)|bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
211320|NCT01522131|P1|Participant Flow|Bioresorbable Membrane Will be Used as the Control|"Bioresorbable membrane (control)~bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)"
211321|NCT01522131|O2|Outcome|Laser With Bioresorabable Membrane (Test)|bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
211322|NCT01522131|O1|Outcome|Bioresorbable Membrane Will be Used as the Control|"Bioresorbable membrane (control)~bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)"
211323|NCT01522131|O2|Outcome|Laser With Bioresorabable Membrane (Test)|bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
211324|NCT01522131|O1|Outcome|Bioresorbable Membrane Will be Used as the Control|"Bioresorbable membrane (control)~bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)"
211325|NCT01522131|E2|Reported Event|Laser With Bioresorabable Membrane (Test)|bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
211326|NCT01522131|E1|Reported Event|Bioresorbable Membrane Will be Used as the Control|"Bioresorbable membrane (control)~bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)"
211327|NCT01521923|B5|Baseline|Total Title|
211328|NCT01521923|B4|Baseline|CZP+MTX / CZP Q2W+MTX|Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 11 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2
211329|NCT01521923|B3|Baseline|CZP+MTX / CZP Q4W+MTX|Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 11 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2
211330|NCT01521923|B2|Baseline|CZP+MTX / PBO+MTX|Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 11 syringe PBO every 2 Weeks + MTX in Period 2
211331|NCT01521923|B1|Baseline|PBO+MTX / PBO+MTX|Placebo (PBO) + Methotrexate (MTX) in Period 11 syringe PBO every 2 Weeks + MTX in Period 2
211332|NCT01521923|P4|Participant Flow|CZP+MTX / CZP Q2W+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211333|NCT01521923|P3|Participant Flow|CZP+MTX / CZP Q4W+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211334|NCT01521923|P2|Participant Flow|CZP+MTX / PBO+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211335|NCT01521923|P1|Participant Flow|PBO+MTX / PBO+MTX|"Placebo (PBO) + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211336|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211337|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211338|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211339|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211341|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211343|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211344|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211345|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211346|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211347|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211348|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211349|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211350|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211351|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211352|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211353|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211354|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211355|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211356|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211357|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211358|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211359|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211360|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211361|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211362|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211363|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211364|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211365|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211366|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211367|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211368|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211369|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211370|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211371|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
214159|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
211372|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211373|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211374|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211375|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211376|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211377|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211378|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211379|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211380|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211381|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211382|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211383|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211384|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211385|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211386|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211387|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211388|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211389|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211390|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211391|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211392|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211393|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211394|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211395|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211396|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211397|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211398|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211399|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211400|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211401|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211402|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211403|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211404|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211405|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211406|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211407|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211408|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211409|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211410|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211411|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211412|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211413|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211414|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211415|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211416|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211417|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211418|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211419|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211420|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211421|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211422|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211423|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211424|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211425|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211426|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211427|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211428|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211429|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211505|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
211430|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211431|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211432|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211433|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211434|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211435|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211436|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211437|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211438|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211439|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211440|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211441|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211442|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211443|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211444|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211445|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211446|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211447|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211448|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211449|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set [FAS])|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211450|NCT01521923|E4|Reported Event|CZP+MTX / CZP Q2W+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
211451|NCT01521923|E3|Reported Event|CZP+MTX / CZP Q4W+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
211452|NCT01521923|E2|Reported Event|CZP+MTX / PBO+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211453|NCT01521923|E1|Reported Event|PBO+MTX / PBO+MTX|"Placebo (PBO) + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
211454|NCT01521897|B1|Baseline|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
211455|NCT01521897|P1|Participant Flow|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
211456|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
211547|NCT01521780|O3|Outcome|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
211548|NCT01521780|O2|Outcome|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
211457|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
211458|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
211459|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
211460|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
211461|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
211462|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
211463|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
211464|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
211465|NCT01521897|E1|Reported Event|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
211466|NCT01521884|B1|Baseline|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
211467|NCT01521884|P1|Participant Flow|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
211468|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
211469|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
211470|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
211471|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
211472|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
211473|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
211474|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
211475|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
211476|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
211549|NCT01521780|O1|Outcome|Imaging|Magnetic resonance imaging (MRI) of HCC tumor.
211550|NCT01521780|O1|Outcome|Imaging and Imaging/Pathology|Magnetic resonance imaging (MRI) of HCC tumor.
211477|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
211478|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
211479|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
211480|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
211481|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
211482|NCT01521884|E1|Reported Event|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
211483|NCT01521871|B3|Baseline|Total|Total of all reporting groups
211484|NCT01521871|B2|Baseline|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue : The glue is used both as closure device and as wound dressing."
211485|NCT01521871|B1|Baseline|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing : Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
211486|NCT01521871|P2|Participant Flow|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue : The glue is used both as closure device and as wound dressing."
211487|NCT01521871|P1|Participant Flow|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing : Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
211488|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
211489|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
211490|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
211491|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
211492|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
211493|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
211494|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
211495|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
211496|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
211497|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
211498|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
211499|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
211500|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
211501|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
211502|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
211503|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
211504|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
211506|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
211507|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
211508|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
211509|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
211510|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
211511|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
211512|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
211513|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
211514|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
211515|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
211516|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
211517|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
211518|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
211519|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
211520|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
211521|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
211522|NCT01521871|E2|Reported Event|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue : The glue is used both as closure device and as wound dressing."
211523|NCT01521871|E1|Reported Event|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing : Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
211524|NCT01521845|B3|Baseline|Total|Total of all reporting groups
211525|NCT01521845|B2|Baseline|Control|This group is without omega 3 : just receives standard treatment
211526|NCT01521845|B1|Baseline|Omega 3|receive omega 3 in addition to standard treatment
211527|NCT01521845|P2|Participant Flow|Control|This group is without omega 3 : just receives standard treatment
211528|NCT01521845|P1|Participant Flow|Omega 3|receive omega 3 in addition to standard treatment
211529|NCT01521845|O2|Outcome|Control|This group is without omega 3 : just receives standard treatment
211530|NCT01521845|O1|Outcome|Omega 3|receive omega 3 in addition to standard treatment
211531|NCT01521845|O2|Outcome|Control|This group is without omega 3 : just receives standard treatment
211532|NCT01521845|O1|Outcome|Omega 3|receive omega 3 in addition to standard treatment
211533|NCT01521845|O2|Outcome|Control|This group is without omega 3 : just receives standard treatment
211534|NCT01521845|O1|Outcome|Omega 3|receive omega 3 in addition to standard treatment
211535|NCT01521845|E2|Reported Event|Control|This group is without omega 3 : just receives standard treatment
211536|NCT01521845|E1|Reported Event|Omega 3|receive omega 3 in addition to standard treatment
211537|NCT01521780|B1|Baseline|All Participants|Participants who enrolled in the study
211538|NCT01521780|P3|Participant Flow|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
211539|NCT01521780|P2|Participant Flow|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
211540|NCT01521780|P1|Participant Flow|Imaging|Magnetic resonance imaging (MRI) of Hepatocellular carcinoma (HCC) tumor.
211541|NCT01521780|O3|Outcome|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
211542|NCT01521780|O2|Outcome|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
211543|NCT01521780|O1|Outcome|Imaging|Magnetic resonance imaging (MRI) of HCC tumor.
211544|NCT01521780|O3|Outcome|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
211545|NCT01521780|O2|Outcome|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
211546|NCT01521780|O1|Outcome|Imaging|Magnetic resonance imaging (MRI) of HCC tumor.
211552|NCT01521780|O3|Outcome|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
211553|NCT01521780|O2|Outcome|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
211554|NCT01521780|O1|Outcome|Imaging|Magnetic resonance imaging (MRI) of HCC tumor.
211555|NCT01521780|O3|Outcome|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
211556|NCT01521780|O2|Outcome|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
211557|NCT01521780|O1|Outcome|Imaging|Magnetic resonance imaging (MRI) of HCC tumor.
211558|NCT01521780|E3|Reported Event|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
211559|NCT01521780|E2|Reported Event|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
211560|NCT01521780|E1|Reported Event|Imaging|Magnetic resonance imaging (MRI) of HCC tumor.
211561|NCT01521559|B3|Baseline|Total|Total of all reporting groups
211562|NCT01521559|B2|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group could receive laser rescue at week 36.
211563|NCT01521559|B1|Baseline|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants received treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing.
211564|NCT01521559|P2|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 milligrams (mg) Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group could receive laser rescue at week 36.
211565|NCT01521559|P1|Participant Flow|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants received treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing.
211566|NCT01521559|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24.
211567|NCT01521559|O1|Outcome|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24.
211568|NCT01521559|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24
211569|NCT01521559|O1|Outcome|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24.
211570|NCT01521559|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24.
211571|NCT01521559|O1|Outcome|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24.
211572|NCT01521559|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24.
211573|NCT01521559|O1|Outcome|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24.
211574|NCT01521559|E2|Reported Event|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group could receive laser rescue at week 36.
211575|NCT01521559|E1|Reported Event|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants received treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing.
211576|NCT01521546|B3|Baseline|Total|Total of all reporting groups
211577|NCT01521546|B2|Baseline|Placebo|"placebo~placebo: one tablet by mouth daily for 12 months"
211578|NCT01521546|B1|Baseline|Eplerenone|"active study drug~eplerenone: 25mg tablet, once daily by mouth for 12 months"
211579|NCT01521546|P2|Participant Flow|Eplerenone|"active study drug~eplerenone: 25mg tablet, once daily by mouth for 12 months"
211580|NCT01521546|P1|Participant Flow|Placebo|"placebo~placebo: one tablet by mouth daily for 12 months"
211581|NCT01521546|O2|Outcome|Eplerenone|eplerenone one tablet by mouth daily for 12 months
211582|NCT01521546|O1|Outcome|Placebo|placebo: one tablet by mouth daily for 12 months
211583|NCT01521546|E2|Reported Event|Eplerenone|eplerenone one tablet daily for 12 months
211584|NCT01521546|E1|Reported Event|Placebo|placebo one tablet daily for 12 months
211585|NCT01521507|B3|Baseline|Total|Total of all reporting groups
211586|NCT01521507|B2|Baseline|Warm Compress & Lid Hygiene|Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
211587|NCT01521507|B1|Baseline|LipiFlow Treatment|Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
211605|NCT01521364|B1|Baseline|Clarithromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
211588|NCT01521507|P2|Participant Flow|Warm Compress & Lid Hygiene, Then Crossover LipiFlow Treatment|"Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3 months in Stage 1. Then, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief:~One LipiFlow Treatment - After subjects received one LipiFlow treatment at crossover, no other MGD or dry eye treatment was prescribed for the study duration.~Two LipiFlow Treatments - Subjects received a second LipiFlow treatment during Stage 2. No other MGD or dry eye treatment was prescribed for the study duration.~Combination Treatment - After subjects received one or two LipiFlow treatments, they received other MGD or dry eye treatment, as prescribed by the physician."
211589|NCT01521507|P1|Participant Flow|LipiFlow Treatment|"Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief:~One LipiFlow Treatment - After subjects received one LipiFlow treatment at randomization, no other MGD or dry eye treatment was prescribed for the study duration.~Two LipiFlow Treatments - Subjects received a second LipiFlow treatment during Stage 2. No other MGD or dry eye treatment was prescribed for the study duration.~Combination Treatment - After subjects received one or two LipiFlow treatments, they received other MGD or dry eye treatment, as prescribed by the physician."
211590|NCT01521507|O4|Outcome|Warm Compress/Hygiene Arm: Combination Treatment Subgroup|"After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at crossover) or two LipiFlow treatments followed by other MGD or dry eye treatment, as prescribed by the physician."
211591|NCT01521507|O3|Outcome|Warm Compress/Hygiene Arm: One LipiFlow Treatment Subgroup|"After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration."
211592|NCT01521507|O2|Outcome|LipiFlow Arm: Combination Treatment Subgroup|"Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at randomization) followed by other MGD or dry eye treatment, as prescribed by the physician."
211593|NCT01521507|O1|Outcome|LipiFlow Arm: One LipiFlow Treatment Subgroup|"Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration."
211594|NCT01521507|O2|Outcome|Warm Compress & Lid Hygiene|Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
211595|NCT01521507|O1|Outcome|LipiFlow Treatment|Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
211596|NCT01521507|O4|Outcome|Warm Compress/Hygiene Arm: Combination Treatment Subgroup|"After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at crossover) or two LipiFlow treatments followed by other MGD or dry eye treatment, as prescribed by the physician."
211597|NCT01521507|O3|Outcome|Warm Compress/Hygiene Arm: One LipiFlow Treatment Subgroup|"After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration."
211598|NCT01521507|O2|Outcome|LipiFlow Arm: Combination Treatment Subgroup|"Subjects received a single, 12-minute, in-office LipiFlow treatment of both eyes after randomization in Stage 1.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at randomization) followed by other MGD or dry eye treatment, as prescribed by the physician."
211599|NCT01521507|O1|Outcome|LipiFlow Arm: One LipiFlow Treatment Subgroup|"Subjects received a single, 12-minute, in-office LipiFlow treatment of both eyes after randomization in Stage 1.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration."
211600|NCT01521507|O2|Outcome|Warm Compress & Lid Hygiene|Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
211601|NCT01521507|O1|Outcome|LipiFlow Treatment|Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
211602|NCT01521507|E3|Reported Event|Crossover LipiFlow Treatment|After using twice-daily, standardized warm compress therapy and lid hygiene for 3 months, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.
211603|NCT01521507|E2|Reported Event|Warm Compress & Lid Hygiene|Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
211604|NCT01521507|E1|Reported Event|LipiFlow Treatment|Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
211606|NCT01521364|P1|Participant Flow|0mg, 250mg and 500mg Claritromycin|Patients receive 300mg linezolid twice a day during entire study.
211626|NCT01521143|B4|Baseline|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
211704|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211607|NCT01521364|O3|Outcome|500mg Clarithromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
211608|NCT01521364|O2|Outcome|250mg Clarithromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
211609|NCT01521364|O1|Outcome|0mg Claritromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
211610|NCT01521364|O3|Outcome|500mg Clarithromycin|
211611|NCT01521364|O2|Outcome|250mg Clarithromycin|
211612|NCT01521364|O1|Outcome|0mg Claritrhomycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
211613|NCT01521364|E3|Reported Event|500mg Clarithromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
211614|NCT01521364|E2|Reported Event|250mg Clarithromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
211615|NCT01521364|E1|Reported Event|0mg Claritromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
211616|NCT01521260|B3|Baseline|Total|Total of all reporting groups
211617|NCT01521260|B2|Baseline|Chlorhexidine Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.
211618|NCT01521260|B1|Baseline|Placebo Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.
211619|NCT01521260|P2|Participant Flow|Chlorhexidine Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.
211620|NCT01521260|P1|Participant Flow|Placebo Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.
211621|NCT01521260|O2|Outcome|Chlorhexidine Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.
211622|NCT01521260|O1|Outcome|Placebo Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.
211623|NCT01521260|E2|Reported Event|Chlorhexidine Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.
211624|NCT01521260|E1|Reported Event|Placebo Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.
211627|NCT01521143|B3|Baseline|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
211628|NCT01521143|B2|Baseline|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
211629|NCT01521143|B1|Baseline|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
211630|NCT01521143|P4|Participant Flow|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
211631|NCT01521143|P3|Participant Flow|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
211632|NCT01521143|P2|Participant Flow|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
211633|NCT01521143|P1|Participant Flow|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
211634|NCT01521143|O4|Outcome|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
211635|NCT01521143|O3|Outcome|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
211636|NCT01521143|O2|Outcome|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
211637|NCT01521143|O1|Outcome|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
211638|NCT01521143|O4|Outcome|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
211639|NCT01521143|O3|Outcome|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
211640|NCT01521143|O2|Outcome|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
211641|NCT01521143|O1|Outcome|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
211642|NCT01521143|O4|Outcome|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
211643|NCT01521143|O3|Outcome|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
211644|NCT01521143|O2|Outcome|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
211645|NCT01521143|O1|Outcome|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
211646|NCT01521143|O4|Outcome|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
211647|NCT01521143|O3|Outcome|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
211648|NCT01521143|O2|Outcome|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
211649|NCT01521143|O1|Outcome|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
211650|NCT01521143|O4|Outcome|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
211651|NCT01521143|O3|Outcome|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
211652|NCT01521143|O2|Outcome|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
211653|NCT01521143|O1|Outcome|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
211654|NCT01521143|O4|Outcome|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
211655|NCT01521143|O3|Outcome|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
211656|NCT01521143|O2|Outcome|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
211657|NCT01521143|O1|Outcome|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
211658|NCT01521143|E4|Reported Event|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
211659|NCT01521143|E3|Reported Event|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
211660|NCT01521143|E2|Reported Event|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
211661|NCT01521143|E1|Reported Event|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
211662|NCT01521026|B3|Baseline|Total|Total of all reporting groups
211663|NCT01521026|B2|Baseline|Standard Pharmacotherapy|standard pharmacotherapy with regular clinician
211664|NCT01521026|B1|Baseline|Cognitive Training|Cognitive training group
211665|NCT01521026|P2|Participant Flow|Standard Pharmacotherapy|Standard pharmacotherapy with regular clinician
211666|NCT01521026|P1|Participant Flow|Cognitive Training|Cognitive training group
211667|NCT01521026|O2|Outcome|Standard Pharmacotherapy|Standard pharmacotherapy with the regular clinician
211668|NCT01521026|O1|Outcome|Cognitive Training|Cognitive training group
211669|NCT01521026|O2|Outcome|Standard Pharmacotherapy|Standard pharmacotherapy with the regular clinician
211670|NCT01521026|O1|Outcome|Cognitive Training|Cognitive training group
211671|NCT01521026|E2|Reported Event|Standard Pharmacotherapy|standard pharmacotherapy with regular clinician
211672|NCT01521026|E1|Reported Event|Cognitive Training|Cognitive training group
211673|NCT01520987|B9|Baseline|Total|Total of all reporting groups
211674|NCT01520987|B8|Baseline|Japanese Placebo|"Placebo, PLC~Placebo: once-daily"
211675|NCT01520987|B7|Baseline|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211676|NCT01520987|B6|Baseline|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211677|NCT01520987|B5|Baseline|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211678|NCT01520987|B4|Baseline|Caucasian Placebo|"Placebo, PLC~Placebo: once-daily"
211679|NCT01520987|B3|Baseline|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211680|NCT01520987|B2|Baseline|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211681|NCT01520987|B1|Baseline|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211682|NCT01520987|P8|Participant Flow|Japanese Placebo|"Placebo, PLC~Placebo: once-daily"
211683|NCT01520987|P7|Participant Flow|Japanese 50 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
211684|NCT01520987|P6|Participant Flow|Japanese 25 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
211685|NCT01520987|P5|Participant Flow|Japanese 5 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
211686|NCT01520987|P4|Participant Flow|Caucasian Placebo|"Placebo, PLC~Placebo: once-daily"
211687|NCT01520987|P3|Participant Flow|Caucasian 50 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
211688|NCT01520987|P2|Participant Flow|Caucasian 25 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
211689|NCT01520987|P1|Participant Flow|Caucasian 5 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
211690|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211691|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211692|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211693|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211694|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211695|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211696|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211697|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211698|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211699|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211700|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211701|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211702|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211703|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211705|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211706|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211707|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211708|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211709|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211710|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211711|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211712|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211713|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211714|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211715|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211716|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211717|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211718|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211719|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211720|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211721|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211722|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211723|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211724|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211725|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211726|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211727|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211728|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211729|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211730|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211731|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211732|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211733|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211734|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211735|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211736|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211737|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211738|NCT01520987|E8|Reported Event|Japanese Placebo|"Placebo, PLC~Placebo: once-daily"
211739|NCT01520987|E7|Reported Event|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211740|NCT01520987|E6|Reported Event|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211741|NCT01520987|E5|Reported Event|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211742|NCT01520987|E4|Reported Event|Caucasian Placebo|"Placebo, PLC~Placebo: once-daily"
211743|NCT01520987|E3|Reported Event|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211744|NCT01520987|E2|Reported Event|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211745|NCT01520987|E1|Reported Event|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
211746|NCT01520922|B3|Baseline|Total|Total of all reporting groups
211747|NCT01520922|B2|Baseline|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211748|NCT01520922|B1|Baseline|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211893|NCT01520727|P1|Participant Flow|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211749|NCT01520922|P2|Participant Flow|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211750|NCT01520922|P1|Participant Flow|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211751|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211752|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211753|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211754|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211755|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211756|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211757|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211758|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211759|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211760|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211761|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211762|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211763|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211764|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211894|NCT01520727|O8|Outcome|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211765|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211766|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211767|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211768|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211769|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211770|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211771|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211772|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211773|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211774|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211775|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211776|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211777|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211778|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211779|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211780|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211895|NCT01520727|O7|Outcome|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211781|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211782|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211783|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211784|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211785|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211786|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211787|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211788|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211789|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211790|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211791|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211792|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211793|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211794|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211795|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211796|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211896|NCT01520727|O6|Outcome|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211797|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211798|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211799|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211800|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211801|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211802|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211803|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211804|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211805|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211806|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211807|NCT01520922|E2|Reported Event|Ofatumumab + Bendamustine 90mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211808|NCT01520922|E1|Reported Event|Ofatumumab + Bendamustine 70mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
211809|NCT01520909|B3|Baseline|Total|Total of all reporting groups
211810|NCT01520909|B2|Baseline|Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight &lt;27 kg received eltrombopag 37.5 mg QD, and those with a body weight &gt;=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day. Participants continued on the same dose of eltrombopag in Part 2 unless adjustments were warranted according to the dosing guidelines.
211811|NCT01520909|B1|Baseline|Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day. In Part 2, participants received eltrombopag. Participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211839|NCT01520909|O2|Outcome|Part 1 (Randomized Period)-Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211812|NCT01520909|P3|Participant Flow|Part 2 (Open-Label Period) Eltrombopag|All participants receiving placebo in Part 1 received eltrombopag in Part 2 following starting dose guidelines for Part 1. Participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day. Participants receiving eltrombopag in Part 1 continued on the same dose of eltrombopag in Part 2 unless adjustments were warranted according to the dosing guidelines. Standard of care treatments were allowed during the study, and were prescribed based on the investigator's discretion.
211813|NCT01520909|P2|Participant Flow|Part 1 (Randomized Period)-Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day. Participants continued on the same dose of eltrombopag in Part 2 unless adjustments were warranted according to the dosing guidelines. Standard of care treatments were allowed during the study, and were prescribed based on the investigator's discretion.
211814|NCT01520909|P1|Participant Flow|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kilograms (kg) received placebo 37.5 milligrams (mg) once daily (QD), and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 milligrams per kilogram (mg/kg) QD; participants of East Asian ancestry received a starting dose of placebo 0.8 milligrams per kilograms per day (mg/kg/day). Standard of care treatments were allowed during the study, and were prescribed based on the investigator's discretion.
211815|NCT01520909|O3|Outcome|Eltrombopag Cohort 3 (1-5 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211816|NCT01520909|O2|Outcome|Eltrombopag Cohort 2 (6-11 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
211817|NCT01520909|O1|Outcome|Eltrombopag Cohort 1 (12-17 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
211818|NCT01520909|O3|Outcome|Eltrombopag Cohort 3 (1-5 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211819|NCT01520909|O2|Outcome|Eltrombopag Cohort 2 (6-11 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
211820|NCT01520909|O1|Outcome|Eltrombopag Cohort 1 (12-17 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
211821|NCT01520909|O3|Outcome|Eltrombopag Cohort 3 (1-5 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211822|NCT01520909|O2|Outcome|Eltrombopag Cohort 2 (6-11 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
211823|NCT01520909|O1|Outcome|Eltrombopag Cohort 1 (12-17 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
211824|NCT01520909|O3|Outcome|Eltrombopag Cohort 3 (1-5 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211825|NCT01520909|O2|Outcome|Eltrombopag Cohort 2 (6-11 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
211826|NCT01520909|O1|Outcome|Eltrombopag Cohort 1 (12-17 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
211827|NCT01520909|O3|Outcome|Eltrombopag Cohort 3 (1-5 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211828|NCT01520909|O2|Outcome|Eltrombopag Cohort 2 (6-11 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
211829|NCT01520909|O1|Outcome|Eltrombopag Cohort 1 (12-17 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
211830|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211831|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211832|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight &lt;27 kg received eltrombopag 37.5 mg QD, and those with a body weight &gt;=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211833|NCT01520909|O1|Outcome|Part 1 (Randomized Period) - Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
211834|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211835|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211836|NCT01520909|O2|Outcome|Part 1 (Randomized Period)-Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211837|NCT01520909|O1|Outcome|EPart 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
211838|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
212409|NCT01519700|O1|Outcome|EP2006 + EP2006 & Neupogen|All subjects randomized to receive either EP2006 in Cycle 1
211840|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
211841|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211842|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211843|NCT01520909|O1|Outcome|Part 1(Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
211844|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211845|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211846|NCT01520909|O1|Outcome|Part 1 (Randmoized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
211847|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211848|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211849|NCT01520909|O1|Outcome|Part 1 (Randmoized Period) -Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
211850|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211851|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211865|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
212410|NCT01519700|O3|Outcome|Total|All patients in Cycle 1
211852|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211853|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211854|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211855|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211856|NCT01520909|O2|Outcome|Part 1 (Randomized Period) -Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211857|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
211858|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211859|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
211860|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211861|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
211862|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211863|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
211864|NCT01520909|O2|Outcome|Part 1 (Randomized Period)-Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211892|NCT01520727|P2|Participant Flow|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
212411|NCT01519700|O2|Outcome|Neupogen + Neupogen & EP2006|All subjects randomized to receive Neupogen in Cycle 1
211866|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211867|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
211868|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211869|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
211870|NCT01520909|O2|Outcome|Part 1 (Randomized Period)-Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211871|NCT01520909|O1|Outcome|Part 1 (Randomized Period)- Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kilograms (kg) received placebo 37.5 milligrams (mg) once daily (QD), and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 milligrams per kilogram (mg/kg) QD; participants of East Asian ancestry received a starting dose of placebo 0.8 milligrams per kilograms per day (mg/kg/day).
211872|NCT01520909|E3|Reported Event|Part 2: Eltrombopag|In Part 2, participants continued on the same dose of eltrombopag received in Part 1 unless adjustments were warranted according to the dosing guidelines.
211873|NCT01520909|E2|Reported Event|Part 1: Placebo|In Part 1, participants aged between 6 and 17 years with a body weight less than 27 kg received placebo 37.5 mg QD, and those with a body weight greater than or equal to 27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
211874|NCT01520909|E1|Reported Event|Part 1: Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight less than 27 kg received eltrombopag 37.5 mg QD, and those with a body weight greater than or equal to 27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
211875|NCT01520727|B10|Baseline|Total|Total of all reporting groups
211876|NCT01520727|B9|Baseline|Placebo|"Placebo (PLC): single-dose~Placebo: single-dose"
211877|NCT01520727|B8|Baseline|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211878|NCT01520727|B7|Baseline|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211879|NCT01520727|B6|Baseline|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211880|NCT01520727|B5|Baseline|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211881|NCT01520727|B4|Baseline|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211882|NCT01520727|B3|Baseline|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211883|NCT01520727|B2|Baseline|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211884|NCT01520727|B1|Baseline|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211885|NCT01520727|P9|Participant Flow|Placebo|"Placebo (PLC): single-dose~Placebo: single-dose"
211886|NCT01520727|P8|Participant Flow|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211887|NCT01520727|P7|Participant Flow|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211888|NCT01520727|P6|Participant Flow|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211889|NCT01520727|P5|Participant Flow|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211890|NCT01520727|P4|Participant Flow|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211891|NCT01520727|P3|Participant Flow|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
212412|NCT01519700|O1|Outcome|EP2006 + EP2006 & Neupogen|All subjects randomized to receive either EP2006 in Cycle 1
211897|NCT01520727|O5|Outcome|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211898|NCT01520727|O4|Outcome|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211899|NCT01520727|O3|Outcome|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211900|NCT01520727|O2|Outcome|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211901|NCT01520727|O1|Outcome|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211902|NCT01520727|O8|Outcome|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211903|NCT01520727|O7|Outcome|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211904|NCT01520727|O6|Outcome|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211905|NCT01520727|O5|Outcome|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211906|NCT01520727|O4|Outcome|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211907|NCT01520727|O3|Outcome|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211908|NCT01520727|O2|Outcome|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211909|NCT01520727|O1|Outcome|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211910|NCT01520727|O9|Outcome|Placebo|"Placebo (PLC): single-dose~Placebo: single-dose"
211911|NCT01520727|O8|Outcome|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211912|NCT01520727|O7|Outcome|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211913|NCT01520727|O6|Outcome|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211914|NCT01520727|O5|Outcome|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211915|NCT01520727|O4|Outcome|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211916|NCT01520727|O3|Outcome|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211917|NCT01520727|O2|Outcome|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211918|NCT01520727|O1|Outcome|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211919|NCT01520727|E9|Reported Event|Placebo|"Placebo (PLC): single-dose~Placebo: single-dose"
211920|NCT01520727|E8|Reported Event|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211921|NCT01520727|E7|Reported Event|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211922|NCT01520727|E6|Reported Event|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211923|NCT01520727|E5|Reported Event|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211924|NCT01520727|E4|Reported Event|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211925|NCT01520727|E3|Reported Event|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211926|NCT01520727|E2|Reported Event|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211927|NCT01520727|E1|Reported Event|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
211928|NCT01520714|B3|Baseline|Total|Total of all reporting groups
211929|NCT01520714|B2|Baseline|Medtronic 4195 Active Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
211930|NCT01520714|B1|Baseline|Medtronic Passive Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
212207|NCT01519817|O3|Outcome|40 YU (Dose Level 3)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
211931|NCT01520714|P2|Participant Flow|Medtronic 4195 Active Fixation LV Lead|"Medtronic 4195 Active Fixation LV Lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
211932|NCT01520714|P1|Participant Flow|Medtronic Passive Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
211933|NCT01520714|O2|Outcome|Medtronic 4195 Active Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms both had same follow-up testing and schedule.~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead: 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images were taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
211934|NCT01520714|O1|Outcome|Medtronic Passive Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms both had same follow-up testing and schedule.~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead: 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images were taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
211935|NCT01520714|E2|Reported Event|Medtronic Passive Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
211936|NCT01520714|E1|Reported Event|Medtronic 4195 Active Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
211937|NCT01520558|B4|Baseline|Total|Total of all reporting groups
211938|NCT01520558|B3|Baseline|CNDO-109-AANK Cells Dose 3|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the highest dose of these three doses (dose 3) is 3×10^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.~CNDO-109-AANK Cells: Single dose, infusion"
211939|NCT01520558|B2|Baseline|CNDO-109-AANK Cells Dose 2|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the middle dose of these three doses (dose 2) is 1×10^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.~CNDO-109-AANK Cells: Single dose, infusion"
211940|NCT01520558|B1|Baseline|CNDO-109-AANK Cells Dose 1|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the lowest of these three doses (dose 1) is 3×10^5 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.~CNDO-109-AANK Cells: Single dose, infusion"
211941|NCT01520558|P3|Participant Flow|CNDO-109-AANK Cells Dose 3|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the highest dose of these three doses (dose 3) is 3×10^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.~CNDO-109-AANK Cells: Single dose, infusion"
211942|NCT01520558|P2|Participant Flow|CNDO-109-AANK Cells Dose 2|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the middle dose of these three doses (dose 2) is 1×10^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.~CNDO-109-AANK Cells: Single dose, infusion"
211943|NCT01520558|P1|Participant Flow|CNDO-109-AANK Cells Dose 1|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the lowest of these three doses (dose 1) is 3×10^5 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.~CNDO-109-AANK Cells: Single dose, infusion"
211944|NCT01520558|O3|Outcome|CNDO-109-AANK Cells Dose 3|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the highest dose of these three doses (dose 3) is 3×10^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.~CNDO-109-AANK Cells: Single dose, infusion"
211945|NCT01520558|O2|Outcome|CNDO-109-AANK Cells Dose 2|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the middle dose of these three doses (dose 2) is 1×10^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.~CNDO-109-AANK Cells: Single dose, infusion"
211946|NCT01520558|O1|Outcome|CNDO-109-AANK Cells Dose 1|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the lowest of these three doses (dose 1) is 3×10^5 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.~CNDO-109-AANK Cells: Single dose, infusion"
211947|NCT01520558|E3|Reported Event|CNDO-109-AANK Cells Dose 3|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the highest dose of these three doses (dose 3) is 3×10^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.~CNDO-109-AANK Cells: Single dose, infusion"
211948|NCT01520558|E2|Reported Event|CNDO-109-AANK Cells Dose 2|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the middle dose of these three doses (dose 2) is 1×10^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.~CNDO-109-AANK Cells: Single dose, infusion"
211949|NCT01520558|E1|Reported Event|CNDO-109-AANK Cells Dose 1|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the lowest of these three doses (dose 1) is 3×10^5 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.~CNDO-109-AANK Cells: Single dose, infusion"
211950|NCT01520532|B1|Baseline|Ablation|
211951|NCT01520532|P1|Participant Flow|Ablation|Single-arm study, all subjects received a radio-frequency (RF) ablation with the goal of achieving Pulmonary Vein Isolation (PVI).
211952|NCT01520532|O1|Outcome|Ablation|
211953|NCT01520532|O1|Outcome|Ablation|
211954|NCT01520532|O1|Outcome|Ablation|
211955|NCT01520532|E1|Reported Event|Ablation|
211956|NCT01520506|B1|Baseline|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
211957|NCT01520506|P1|Participant Flow|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. Radiofrequency (RF) is applied with pre-programmed time and intensity in each of the renal arteries.
211958|NCT01520506|O1|Outcome|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
211959|NCT01520506|O1|Outcome|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
211960|NCT01520506|O1|Outcome|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
211961|NCT01520506|E1|Reported Event|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
211962|NCT01520454|B5|Baseline|Total|Total of all reporting groups
211963|NCT01520454|B4|Baseline|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
211964|NCT01520454|B3|Baseline|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
211965|NCT01520454|B2|Baseline|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
211966|NCT01520454|B1|Baseline|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
211967|NCT01520454|P4|Participant Flow|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
211968|NCT01520454|P3|Participant Flow|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
211969|NCT01520454|P2|Participant Flow|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
211970|NCT01520454|P1|Participant Flow|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per partial thromboplastin time (PTT), for 5.5 hours"
211971|NCT01520454|O4|Outcome|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
211972|NCT01520454|O3|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per partial thromboplastin time (PTT), for 5.5 hours"
211973|NCT01520454|O2|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per partial thromboplastin time (PTT), for 5.5 hours"
211974|NCT01520454|O1|Outcome|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per partial thromboplastin time (PTT), for 5.5 hours"
211975|NCT01520454|O4|Outcome|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
211976|NCT01520454|O3|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
212413|NCT01519700|O5|Outcome|Total|All patients
211977|NCT01520454|O2|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
211978|NCT01520454|O1|Outcome|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
211979|NCT01520454|O4|Outcome|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
211980|NCT01520454|O3|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
211981|NCT01520454|O2|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
211982|NCT01520454|O1|Outcome|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
211983|NCT01520454|O4|Outcome|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
211984|NCT01520454|O3|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
211985|NCT01520454|O2|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
211986|NCT01520454|O1|Outcome|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
211987|NCT01520454|O4|Outcome|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
211988|NCT01520454|O3|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
211989|NCT01520454|O2|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
211990|NCT01520454|O1|Outcome|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
211991|NCT01520454|O4|Outcome|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
211992|NCT01520454|O3|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
211993|NCT01520454|O2|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
211994|NCT01520454|O1|Outcome|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
211995|NCT01520454|O4|Outcome|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
211996|NCT01520454|O3|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
211997|NCT01520454|O2|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
211998|NCT01520454|O1|Outcome|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
211999|NCT01520454|O4|Outcome|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
212000|NCT01520454|O3|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
212001|NCT01520454|O2|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
212002|NCT01520454|O1|Outcome|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
212003|NCT01520454|O4|Outcome|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
212414|NCT01519700|O4|Outcome|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study
212004|NCT01520454|O3|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
212005|NCT01520454|O2|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
212006|NCT01520454|O1|Outcome|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
212007|NCT01520454|E4|Reported Event|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
212008|NCT01520454|E3|Reported Event|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
212009|NCT01520454|E2|Reported Event|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
212010|NCT01520454|E1|Reported Event|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
212011|NCT01520402|B1|Baseline|Warfarin|"Healthy subjects age 18-74 with no medical indication for warfarin therapy, who are free of medications and co-morbid medical conditions with the potential to interfere with warfarin metabolism, and who are willing to follow a fixed vitamin K diet (men 120 micrograms/day, women 90 micrograms/day) are included.~Warfarin : Enrolled subjects on a fixed vitamin K diet followed a standard warfarin dosing algorithm with daily point-of-care INR checks to goal INR ≥ 2 for two consecutive days, then to baseline INR≤1.2 off warfarin. Genotyping for common and rare polymorphisms in CYP2C9, VKORC1, and CYP4F2 performed at study entry and unblinded at completion. Plasma Vitamin K and S-warfarin levels are obtained at goal INR ≥ 2 and study exit (INR ≤1.2 off warfarin)."
212012|NCT01520402|P1|Participant Flow|Warfarin|"Healthy subjects age 18-74 with no medical indication for warfarin therapy, who are free of medications and co-morbid medical conditions with the potential to interfere with warfarin metabolism, and who are willing to follow a fixed vitamin K diet (men 120 micrograms/day, women 90 micrograms/day) are included.~Warfarin : Enrolled subjects on a fixed vitamin K diet followed a standard warfarin dosing algorithm with daily point-of-care INR checks to goal INR ≥ 2 for two consecutive days, then to baseline INR≤1.2 off warfarin. Genotyping for common and rare polymorphisms in CYP2C9, VKORC1, and CYP4F2 performed at study entry and unblinded at completion. Plasma Vitamin K and S-warfarin levels are obtained at goal INR ≥ 2 and study exit (INR ≤1.2 off warfarin)."
212013|NCT01520402|O1|Outcome|CYP2C9/VKORC1 Genotype Group|Group 1 (CYP2C9 wild-type and VKORC1 wild-type), Group 2 (CYP2C9 wild-type and VKORC1 variant), Group 3 (CYP2C9 variant and VKORC1 wild-type), and Group 4 (CYP2C9 variant and VKORC1 variant).
212014|NCT01520402|O4|Outcome|Demographic Plus CYP2C9 and VKORC1 and CYP4F2|
212015|NCT01520402|O3|Outcome|Demographic Plus CYP2C9 and VKORC1|
212016|NCT01520402|O2|Outcome|Demographic Plus CYP2C9|
212017|NCT01520402|O1|Outcome|Demographic Only|Demographic variables were gender, age, and race.
212018|NCT01520402|O1|Outcome|CYP4F2 (p.V433M; c.1297G>A)|"CYP4F2 G/G was defined as wild-type, CYP4F2 G/A was defined as single-variant, and CYP4F2 A/A was defined as double-variant"
212019|NCT01520402|O2|Outcome|VKORC1 -1639 G>A|"VKORC1 GG was defined as wild-type; VKORC1 G/A was defined as single variant; and VKORC1 A/A was defined as double variant."
212020|NCT01520402|O1|Outcome|CYP2C9|"The wild-type CYP2C9 allele (*1) was assigned in the absence of other detectable variant alleles. Extensive metabolizers (EMs) were defined as *1/*1 wild-type, intermediate metabolizers (IMs) as *1/variant single variant; and poor metabolizers (PMs) as variant/variant double variant."
212021|NCT01520402|E1|Reported Event|Warfarin|Enrolled subjects on a fixed vitamin K diet followed a standard warfarin dosing algorithm with daily point-of-care INR checks to goal INR ≥ 2 for two consecutive days, then to baseline INR≤1.2 off warfarin. Genotyping for common and rare polymorphisms in CYP2C9, VKORC1, and CYP4F2 performed at study entry and unblinded at completion. Plasma Vitamin K and S-warfarin levels are obtained at goal INR ≥ 2 and study exit (INR ≤1.2 off warfarin).
212022|NCT01520207|B3|Baseline|Total|Total of all reporting groups
212023|NCT01520207|B2|Baseline|Intervention: Intravenous Mannitol (20%)|"Mannitol will be administered (IV) during the hemodialysis session at a maximum rate of 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.~Mannitol (20%): 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session)"
212024|NCT01520207|B1|Baseline|Placebo Group: (0.9% Normal Saline)|"0.9% saline will be administered (IV) during the hemodialysis session at 1.25mL/kg/hour (max 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.~0.9% saline: 1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment"
212025|NCT01520207|P2|Participant Flow|Intervention: Intravenous Mannitol (20%)|"Mannitol will be administered (IV) during the hemodialysis session at a maximum rate of 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.~Mannitol (20%): 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session)"
212026|NCT01520207|P1|Participant Flow|Placebo Group: (0.9% Normal Saline)|"0.9% saline will be administered (IV) during the hemodialysis session at 1.25mL/kg/hour (max 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.~0.9% saline: 1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment"
212158|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
212027|NCT01520207|O2|Outcome|Intervention: Intravenous Mannitol (20%)|"Mannitol will be administered (IV) during the hemodialysis session at a maximum rate of 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.~Mannitol (20%): 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session)"
212028|NCT01520207|O1|Outcome|Placebo Group: (0.9% Normal Saline)|"0.9% saline will be administered (IV) during the hemodialysis session at 1.25mL/kg/hour (max 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.~0.9% saline: 1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment"
212029|NCT01520207|E2|Reported Event|Intervention: Intravenous Mannitol (20%)|"Mannitol will be administered (IV) during the hemodialysis session at a maximum rate of 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.~Mannitol (20%): 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session)"
212030|NCT01520207|E1|Reported Event|Placebo Group: (0.9% Normal Saline)|"0.9% saline will be administered (IV) during the hemodialysis session at 1.25mL/kg/hour (max 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.~0.9% saline: 1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment"
212031|NCT01519960|B4|Baseline|Total|Total of all reporting groups
212032|NCT01519960|B3|Baseline|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212033|NCT01519960|B2|Baseline|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212034|NCT01519960|B1|Baseline|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212035|NCT01519960|P3|Participant Flow|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212036|NCT01519960|P2|Participant Flow|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212037|NCT01519960|P1|Participant Flow|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received peginterferon alfa-2a (PEG-IFN) monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on body surface area (BSA) and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 square meters (m^2), 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; greater than (>) 1.51 m^2, 180 mcg.
212038|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212039|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212040|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212159|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
212636|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
212041|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212042|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212043|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212044|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212045|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212046|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212047|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212048|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212049|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212050|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212051|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212160|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
212052|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212053|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212054|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212055|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212056|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212057|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212058|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212059|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212060|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212061|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212062|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212063|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212161|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
212165|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
212064|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212065|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212066|NCT01519960|O1|Outcome|All Groups Combined|Participants without advanced fibrosis were randomized to receive PEG-IFN monotherapy or were evaluated as untreated control for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for the same duration. For those who received PEG-IFN treatment, each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212067|NCT01519960|O3|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212068|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212069|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212070|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212071|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212072|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212073|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212074|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212075|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212076|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212077|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212078|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212079|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212080|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212081|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212082|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212083|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212084|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212085|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212086|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212087|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212088|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212089|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212090|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212162|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
212091|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212092|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212093|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212094|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212095|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212096|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212097|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212098|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212099|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212100|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212101|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212163|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
212637|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
212102|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212103|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212104|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212105|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212106|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212107|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212108|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212109|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212110|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212111|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212112|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212113|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212114|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212115|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212116|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212117|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212118|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212119|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212120|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212121|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212122|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212123|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212164|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
212124|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212125|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212126|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212127|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212128|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212129|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212130|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212131|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212132|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212133|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212134|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212135|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212136|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
212137|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212138|NCT01519960|E4|Reported Event|Group D: Switch to PEG-IFN Monotherapy|Participants without advanced fibrosis who did not receive treatment and had not experienced HBeAg seroconversion were allowed to switch to PEG-IFN monotherapy. Treatment was given over 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg. Because participants could switch from Group B to Group D for up to 1 year following the Week 48 visit, not all participants had reached FU Week 24 at time of analysis.
212139|NCT01519960|E3|Reported Event|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212140|NCT01519960|E2|Reported Event|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up.
212141|NCT01519960|E1|Reported Event|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
212142|NCT01519934|B1|Baseline|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
212143|NCT01519934|P1|Participant Flow|Ulthera-treated Subjects|All enrolled subjects had received one Ulthera treatment on the face and neck at two treatment depths, 4.5mm and 3.0mm depths, prior to enrollment.
212144|NCT01519934|O1|Outcome|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
212145|NCT01519934|O1|Outcome|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
212146|NCT01519934|O1|Outcome|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
212147|NCT01519934|O1|Outcome|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
212148|NCT01519934|E1|Reported Event|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
212149|NCT01519921|B3|Baseline|Total|Total of all reporting groups
212150|NCT01519921|B2|Baseline|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
212151|NCT01519921|B1|Baseline|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
212152|NCT01519921|P2|Participant Flow|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants received PEGASYS 180mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
212153|NCT01519921|P1|Participant Flow|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received peginterferon alfa-2a (PEGASYS) 180 micrograms (mcg) subcutaneously (SC) once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
212154|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
212155|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
212156|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
212157|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
212166|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
212167|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
212168|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
212169|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
212170|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
212171|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
212172|NCT01519921|E2|Reported Event|PEG-IFN Alfa-2a (YMDD Mutant)|Group B included tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants who received PEGASYS 180mcg subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up.
212173|NCT01519921|E1|Reported Event|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
212174|NCT01519882|B3|Baseline|Total|Total of all reporting groups
212175|NCT01519882|B2|Baseline|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
212176|NCT01519882|B1|Baseline|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
212177|NCT01519882|P2|Participant Flow|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
212178|NCT01519882|P1|Participant Flow|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
212179|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
212180|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
212181|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
212182|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
212183|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
212184|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
212185|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
212186|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
212206|NCT01519817|O4|Outcome|80 YU (Dose Level 4)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212187|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
212188|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
212189|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
212190|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
212191|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
212192|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
212193|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
212194|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
212195|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
212196|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
212197|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
212198|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
212199|NCT01519882|E2|Reported Event|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
212200|NCT01519882|E1|Reported Event|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
212201|NCT01519817|B1|Baseline|All Participants|"All participants who received at least one dose of 4YU, 16YU, 40YU or 80YU.~Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.~GI-6301 (Yeast Brachyury Vaccine): GI-6301 is a heat-killed, recombinant yeast-based vaccine engineered to express the transcription factor, Brachyury. The Brachyury gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wildtype yeast) to produce the final recombinant vaccine product."
212202|NCT01519817|P4|Participant Flow|80 YU (Dose Level 4)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212203|NCT01519817|P3|Participant Flow|40 YU (Dose Level 3)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212204|NCT01519817|P2|Participant Flow|16 YU (Dose Level 2)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212205|NCT01519817|P1|Participant Flow|4 YU (Dose Level 1)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212208|NCT01519817|O2|Outcome|16 YU (Dose Level 2)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212209|NCT01519817|O1|Outcome|4 YU (Dose Level 1)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212210|NCT01519817|O4|Outcome|80 YU (Dose Level 4)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212211|NCT01519817|O3|Outcome|40 YU (Dose Level 3)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212212|NCT01519817|O2|Outcome|16 YU (Dose Level 2)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212213|NCT01519817|O1|Outcome|4 YU (Dose Level 1)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212214|NCT01519817|O4|Outcome|80 YU (Dose Level 4)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212215|NCT01519817|O3|Outcome|40 YU (Dose Level 3)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212216|NCT01519817|O2|Outcome|16 YU (Dose Level 2)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212217|NCT01519817|O1|Outcome|4 YU (Dose Level 1)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212218|NCT01519817|O4|Outcome|80 YU (Dose Level 4)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212219|NCT01519817|O3|Outcome|40 YU (Dose Level 3)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212220|NCT01519817|O2|Outcome|16 YU (Dose Level 2)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212221|NCT01519817|O1|Outcome|4 YU (Dose Level 1)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212222|NCT01519817|O4|Outcome|80 YU (Dose Level 4)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212223|NCT01519817|O3|Outcome|40 YU (Dose Level 3)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212224|NCT01519817|O2|Outcome|16 YU (Dose Level 2)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212225|NCT01519817|O1|Outcome|4 YU (Dose Level 1)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212226|NCT01519817|O4|Outcome|80 YU (Dose Level 4)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212227|NCT01519817|O3|Outcome|40 YU (Dose Level 3)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212228|NCT01519817|O2|Outcome|16 YU (Dose Level 2)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212229|NCT01519817|O1|Outcome|4 YU (Dose Level 1)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212230|NCT01519817|O4|Outcome|80 YU (Dose Level 4)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212231|NCT01519817|O3|Outcome|40 YU (Dose Level 3)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212232|NCT01519817|O2|Outcome|16 YU (Dose Level 2)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212233|NCT01519817|O1|Outcome|4 YU (Dose Level 1)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212234|NCT01519817|O4|Outcome|80 YU (Dose Level 4)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212235|NCT01519817|O3|Outcome|40 YU (Dose Level 3)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212236|NCT01519817|O2|Outcome|16 YU (Dose Level 2)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212237|NCT01519817|O1|Outcome|4 YU (Dose Level 1)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212238|NCT01519817|E4|Reported Event|80 YU (Dose Level 4)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212239|NCT01519817|E3|Reported Event|40 YU (Dose Level 3)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212240|NCT01519817|E2|Reported Event|16 YU (Dose Level 2)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212241|NCT01519817|E1|Reported Event|4 YU (Dose Level 1)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
212242|NCT01519791|B3|Baseline|Total Title|
212322|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
212323|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
212243|NCT01519791|B2|Baseline|Certolizumab Pegol + Methotrexate|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212244|NCT01519791|B1|Baseline|Placebo + Methotrexate|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212245|NCT01519791|P2|Participant Flow|Certolizumab Pegol + Methotrexate|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212246|NCT01519791|P1|Participant Flow|Placebo + Methotrexate|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212247|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212248|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212249|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212250|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212251|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212252|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212253|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212254|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212255|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212256|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212324|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
212638|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
212257|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212258|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212259|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212260|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212261|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212262|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212263|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212264|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212265|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212266|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212267|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212268|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212269|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212270|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212325|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
212800|NCT01518257|B3|Baseline|Total|Total of all reporting groups
212271|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212272|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212273|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212274|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212275|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212276|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212277|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212278|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212279|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212280|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212281|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212282|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212283|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212284|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212326|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
214170|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
212285|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212286|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212287|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212288|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212289|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212290|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212291|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212292|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212293|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212294|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212295|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Radiographic Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212296|NCT01519791|O1|Outcome|Placebo + Methotrexate (Radiographic Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212297|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Radiographic Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212298|NCT01519791|O1|Outcome|Placebo + Methotrexate (Radiographic Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212327|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
214171|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
212299|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Radiographic Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212300|NCT01519791|O1|Outcome|Placebo + Methotrexate (Radiographic Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212301|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Radiographic Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212302|NCT01519791|O1|Outcome|Placebo + Methotrexate (Radiographic Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212303|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212304|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212305|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212306|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212307|NCT01519791|E2|Reported Event|Certolizumab Pegol + Methotrexate|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212308|NCT01519791|E1|Reported Event|Placebo + Methotrexate|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
212309|NCT01519778|B1|Baseline|TR-701 FA|TR701 FA: 1 tablet 200 mg once daily
212310|NCT01519778|P1|Participant Flow|TR-701 FA|TR701 FA: 1 tablet 200 mg once daily
212311|NCT01519778|O1|Outcome|TR-701 FA|TR701 FA: 1 tablet 200 mg once daily
212312|NCT01519778|E1|Reported Event|TR-701 FA|TR701 FA: 1 tablet 200 mg once daily
212313|NCT01519765|B3|Baseline|Total|Total of all reporting groups
212314|NCT01519765|B2|Baseline|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
212315|NCT01519765|B1|Baseline|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
212316|NCT01519765|P2|Participant Flow|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
212317|NCT01519765|P1|Participant Flow|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
212318|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
212319|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
212320|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
212321|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
212328|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
212329|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
212330|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
212331|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
212332|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
212333|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
212334|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
212335|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
212336|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
212337|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
212338|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
212339|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
212340|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
212341|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
212342|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
212343|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
212344|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
212345|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
212346|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
212347|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
212348|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
212349|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
212350|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
212351|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~This same regimen was then repeated every four hours according to protocol."
212352|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
212353|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
212354|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
212355|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
212356|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
212357|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~This same regimen was then repeated every four hours according to protocol."
212358|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
212359|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~This same regimen was then repeated every four hours according to protocol."
212408|NCT01519700|O2|Outcome|Neupogen + Neupogen & EP2006|All subjects randomized to receive Neupogen in Cycle 1
212360|NCT01519765|E2|Reported Event|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
212361|NCT01519765|E1|Reported Event|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
212362|NCT01519713|B4|Baseline|Total|Total of all reporting groups
212363|NCT01519713|B3|Baseline|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
212364|NCT01519713|B2|Baseline|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
212365|NCT01519713|B1|Baseline|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
212366|NCT01519713|P3|Participant Flow|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
212367|NCT01519713|P2|Participant Flow|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
212368|NCT01519713|P1|Participant Flow|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
212369|NCT01519713|O3|Outcome|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
212370|NCT01519713|O2|Outcome|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
212371|NCT01519713|O1|Outcome|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
212372|NCT01519713|O3|Outcome|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
212373|NCT01519713|O2|Outcome|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
212374|NCT01519713|O1|Outcome|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
212375|NCT01519713|O3|Outcome|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
212376|NCT01519713|O2|Outcome|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
212377|NCT01519713|O1|Outcome|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
212378|NCT01519713|O3|Outcome|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
212379|NCT01519713|O2|Outcome|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
212380|NCT01519713|O1|Outcome|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
212381|NCT01519713|O3|Outcome|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
212382|NCT01519713|O2|Outcome|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
212383|NCT01519713|O1|Outcome|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
212384|NCT01519713|O3|Outcome|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
212385|NCT01519713|O2|Outcome|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
212386|NCT01519713|O1|Outcome|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
212387|NCT01519713|E3|Reported Event|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
212388|NCT01519713|E2|Reported Event|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
212389|NCT01519713|E1|Reported Event|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
212390|NCT01519700|B5|Baseline|Total|Total of all reporting groups
212391|NCT01519700|B4|Baseline|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study
212392|NCT01519700|B3|Baseline|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
212393|NCT01519700|B2|Baseline|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle
212394|NCT01519700|B1|Baseline|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study
212395|NCT01519700|P4|Participant Flow|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study, daily dose of 5 mcg/kg body weight, subcutaneously
212396|NCT01519700|P3|Participant Flow|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle, daily dose of 5 mcg/kg body weight, subcutaneously
212397|NCT01519700|P2|Participant Flow|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle, daily dose of 5 mcg/kg body weight, subcutaneously
212398|NCT01519700|P1|Participant Flow|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study daily dose of 5 mcg/kg body weight, subcutaneously
212399|NCT01519700|O5|Outcome|Total|All patients
212400|NCT01519700|O4|Outcome|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study
212401|NCT01519700|O3|Outcome|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
212402|NCT01519700|O2|Outcome|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle
212403|NCT01519700|O1|Outcome|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study
212404|NCT01519700|O3|Outcome|Total|All patients in Cycle 1
212405|NCT01519700|O2|Outcome|EP2006 & Neupogen + Neupogen & EP2006|All subjects randomized to receive EP2006 & Neupogen + Neupogen & EP2006.
212406|NCT01519700|O1|Outcome|EP2006 + Neupogen|All subjects randomized to receive either EP2006 or Neupogen.
212407|NCT01519700|O3|Outcome|Total|All patients in Cycle 1
212415|NCT01519700|O3|Outcome|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
212416|NCT01519700|O2|Outcome|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle
212417|NCT01519700|O1|Outcome|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study
212418|NCT01519700|O5|Outcome|Total|All patients
212419|NCT01519700|O4|Outcome|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study
212420|NCT01519700|O3|Outcome|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
212421|NCT01519700|O2|Outcome|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle
212422|NCT01519700|O1|Outcome|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study
212423|NCT01519700|O2|Outcome|Neupogen + Neupogen & EP2006|All subjects randomized to receive Neupogen in Cycle 1
212424|NCT01519700|O1|Outcome|EP2006 + EP2006 & Neupogen|All subjects randomized to receive either EP2006 in Cycle 1
212425|NCT01519700|E4|Reported Event|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study
212426|NCT01519700|E3|Reported Event|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
212427|NCT01519700|E2|Reported Event|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle
212428|NCT01519700|E1|Reported Event|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study
212429|NCT01519674|B4|Baseline|Total|Total of all reporting groups
212430|NCT01519674|B3|Baseline|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212431|NCT01519674|B2|Baseline|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212432|NCT01519674|B1|Baseline|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
212433|NCT01519674|P3|Participant Flow|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212434|NCT01519674|P2|Participant Flow|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212435|NCT01519674|P1|Participant Flow|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
212436|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212437|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212438|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
212439|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212440|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212441|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
212498|NCT01519518|B1|Baseline|Unfractionated Heparin|"70 units/kg body weight intravenous~unfractionated heparin: 70 units/kg body weight intravenous"
212442|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212443|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212444|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
212445|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212446|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212447|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
212448|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212449|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212450|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
212451|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212452|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212453|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
212454|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212455|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212456|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
212457|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212458|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212459|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
212460|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212461|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212462|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
212463|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212464|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212465|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
212466|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212467|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212468|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
212469|NCT01519674|E3|Reported Event|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212470|NCT01519674|E2|Reported Event|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
212471|NCT01519674|E1|Reported Event|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
212472|NCT01519661|B1|Baseline|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
212473|NCT01519661|P1|Participant Flow|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
212474|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
212499|NCT01519518|P2|Participant Flow|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour~Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
215033|NCT01510158|O1|Outcome|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
212475|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
212476|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
212477|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
212478|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
212479|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
212480|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy. Total number of isolates at each cycle/day: baseline = 279; cycle 1, day 29 = 252; cycle 2, day 85 = 238; cycle 3, day 141 = 210; cycle 4, day 197 = 184; cycle 5, day 253 = 178; cycle 6, day 309 = 164; and completion, day 337 = 158
212481|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
212482|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
212483|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
212484|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
212485|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
212486|NCT01519661|E1|Reported Event|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
212487|NCT01519648|B3|Baseline|Total|Total of all reporting groups
212488|NCT01519648|B2|Baseline|Allo- or Auto- Transplant Recipients|
212489|NCT01519648|B1|Baseline|Acute Leukemia Patients|Patients with de novo or relapsed acute myeloid and lymphoid leukemia
212490|NCT01519648|P2|Participant Flow|Allo- or Auto- Transplant Recipients|
212491|NCT01519648|P1|Participant Flow|Acute Leukemia Patients|Patients with de novo or relapsed acute myeloid and lymphoid leukemia
212492|NCT01519648|O2|Outcome|Allo- or Auto- Transplant Recipients|Allo- or auto- transplant recipients
212493|NCT01519648|O1|Outcome|Acute Leukemia Patients|Patients with de novo or relapsed acute myeloid and lymphoid leukemia
212494|NCT01519648|E2|Reported Event|Allo- or Auto- Transplant Recipients|
212495|NCT01519648|E1|Reported Event|Acute Leukemia Patients|Patients with de novo or relapsed acute myeloid and lymphoid leukemia
212496|NCT01519518|B3|Baseline|Total|Total of all reporting groups
212497|NCT01519518|B2|Baseline|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour~Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
215034|NCT01510158|O3|Outcome|Placebo + Allopurinol|placebo qd plus allopurinol
212500|NCT01519518|P1|Participant Flow|Unfractionated Heparin|"70 units/kg body weight intravenous~unfractionated heparin: 70 units/kg body weight intravenous"
212501|NCT01519518|O2|Outcome|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour~Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
212502|NCT01519518|O1|Outcome|Unfractionated Heparin|"70 units/kg body weight intravenous~unfractionated heparin: 70 units/kg body weight intravenous"
212503|NCT01519518|O2|Outcome|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour~Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
212504|NCT01519518|O1|Outcome|Unfractionated Heparin|"70 units/kg body weight intravenous~unfractionated heparin: 70 units/kg body weight intravenous"
212505|NCT01519518|O2|Outcome|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour~Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
212506|NCT01519518|O1|Outcome|Unfractionated Heparin|"70 units/kg body weight intravenous~unfractionated heparin: 70 units/kg body weight intravenous"
212507|NCT01519518|O2|Outcome|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour~Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
212508|NCT01519518|O1|Outcome|Unfractionated Heparin|"70 units/kg body weight intravenous~unfractionated heparin: 70 units/kg body weight intravenous"
212509|NCT01519518|E2|Reported Event|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour~Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
212510|NCT01519518|E1|Reported Event|Unfractionated Heparin|"70 units/kg body weight intravenous~unfractionated heparin: 70 units/kg body weight intravenous"
212511|NCT01519466|B3|Baseline|Total|Total of all reporting groups
212512|NCT01519466|B2|Baseline|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.~FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
212513|NCT01519466|B1|Baseline|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study~FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
212514|NCT01519466|P2|Participant Flow|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.~FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
212515|NCT01519466|P1|Participant Flow|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study~FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
212516|NCT01519466|O2|Outcome|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.~FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
212517|NCT01519466|O1|Outcome|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study~FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
212518|NCT01519466|O2|Outcome|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.~FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
212519|NCT01519466|O1|Outcome|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study~FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
212520|NCT01519466|O2|Outcome|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.~FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
212521|NCT01519466|O1|Outcome|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study~FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
212522|NCT01519466|E2|Reported Event|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.~FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
212523|NCT01519466|E1|Reported Event|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study~FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
212524|NCT01519427|B1|Baseline|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
212525|NCT01519427|P1|Participant Flow|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
212526|NCT01519427|O1|Outcome|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
212527|NCT01519427|O1|Outcome|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
212528|NCT01519427|O1|Outcome|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
212529|NCT01519427|O1|Outcome|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
212530|NCT01519427|E1|Reported Event|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
212531|NCT01519323|B1|Baseline|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
212532|NCT01519323|P2|Participant Flow|Vemurafenib Dose Escalation Cohort Level 2|Participants received 960 mg of vemurafenib by mouth BID.
212533|NCT01519323|P1|Participant Flow|Vemurafenib Dose Escalation Cohort Level 1|Participants received 720 milligram (mg) of vemurafenib by mouth twice daily (BID).
212557|NCT01519284|O2|Outcome|Group 2|"Day 1 to 7:~BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
212558|NCT01519284|O1|Outcome|Group 1|Placebo at all the dosing times
212534|NCT01519323|O1|Outcome|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
212535|NCT01519323|O1|Outcome|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
212536|NCT01519323|O1|Outcome|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
212537|NCT01519323|O1|Outcome|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
212538|NCT01519323|O1|Outcome|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
212539|NCT01519323|O2|Outcome|Vemurafenib 960 mg|Participants enrolled in the second cohort received vemurafenib 960 mg by mouth BID.
212540|NCT01519323|O1|Outcome|Vemurafenib 720 mg|Participants enrolled in the first cohort received vemurafenib 720 mg by mouth BID.
212541|NCT01519323|O1|Outcome|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
212542|NCT01519323|E1|Reported Event|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
212543|NCT01519284|B6|Baseline|Total|Total of all reporting groups
212544|NCT01519284|B5|Baseline|Group 5|"Day 1 to 7:~Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose~Day 8:~Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose~Entacapone: Entacapone 200 mg~Placebo: placebo (four times a day)~levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)"
212545|NCT01519284|B4|Baseline|Group 4|"Day 1 to 7:~BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose~Placebo: placebo (four times a day)~levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)~BIA 9-1067 30 mg: BIA 9-1067 OPC, Opicapone 30 mg"
212546|NCT01519284|B3|Baseline|Group 3|"Day 1 to 7:~BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose~Placebo: placebo (four times a day)~levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)~BIA 9-1067 15 mg: BIA 9-1067 OPC, Opicapone 15 mg"
212547|NCT01519284|B2|Baseline|Group 2|"Day 1 to 7:~BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose~BIA 9-1067 5 mg: BIA 9-1067 OPC, Opicapone 5 mg~Placebo: placebo (four times a day)~levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)"
212548|NCT01519284|B1|Baseline|Group 1|"Placebo at all the dosing times~Placebo: placebo (four times a day)"
212549|NCT01519284|P5|Participant Flow|Group 5|"Day 1 to 7:~Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose~Day 8:~Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
212550|NCT01519284|P4|Participant Flow|Group 4|"Day 1 to 7:~BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
212551|NCT01519284|P3|Participant Flow|Group 3|"Day 1 to 7:~BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
212552|NCT01519284|P2|Participant Flow|Group 2|"Day 1 to 7:~BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
212553|NCT01519284|P1|Participant Flow|Group 1|Placebo at all the dosing times
212554|NCT01519284|O5|Outcome|Group 5|"Day 1 to 7:~Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose~Day 8:~Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
212555|NCT01519284|O4|Outcome|Group 4|"Day 1 to 7:~BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
212556|NCT01519284|O3|Outcome|Group 3|"Day 1 to 7:~BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
212559|NCT01519284|O5|Outcome|Group 5|"Day 1 to 7:~Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose~Day 8:~Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
212560|NCT01519284|O4|Outcome|Group 4|"Day 1 to 7:~BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
212561|NCT01519284|O3|Outcome|Group 3|"Day 1 to 7:~BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
212562|NCT01519284|O2|Outcome|Group 2|"Day 1 to 7:~BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
212563|NCT01519284|O1|Outcome|Group 1|Placebo at all the dosing times
212564|NCT01519284|O5|Outcome|Group 5|"Day 1 to 7:~Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose~Day 8:~Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
212565|NCT01519284|O4|Outcome|Group 4|"Day 1 to 7:~BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
212566|NCT01519284|O3|Outcome|Group 3|"Day 1 to 7:~BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
212567|NCT01519284|O2|Outcome|Group 2|"Day 1 to 7:~BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
212568|NCT01519284|O1|Outcome|Group 1|Placebo at all the dosing times
212569|NCT01519284|O5|Outcome|Group 5|"Day 1 to 7:~Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose~Day 8:~Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
212570|NCT01519284|O4|Outcome|Group 4|"Day 1 to 7:~BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
212571|NCT01519284|O3|Outcome|Group 3|"Day 1 to 7:~BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
212572|NCT01519284|O2|Outcome|Group 2|"Day 1 to 7:~BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
212573|NCT01519284|O1|Outcome|Group 1|Placebo at all the dosing times
212574|NCT01519284|E5|Reported Event|Group 5|"Day 1 to 7:~Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose~Day 8:~Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
212575|NCT01519284|E4|Reported Event|Group 4|"Day 1 to 7:~BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
212576|NCT01519284|E3|Reported Event|Group 3|"Day 1 to 7:~BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
212577|NCT01519284|E2|Reported Event|Group 2|"Day 1 to 7:~BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
212578|NCT01519284|E1|Reported Event|Group 1|Placebo at all the dosing times
212579|NCT01519271|B3|Baseline|Total|Total of all reporting groups
212580|NCT01519271|B2|Baseline|5-10cm2 Rivastigmine Patch First First Then Placebo Patch|"Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.~5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )~Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).~Each phase lasted 10 weeks."
212581|NCT01519271|B1|Baseline|Placebo Patch First Then 5-10cm2 Rivastigmine Patch|"Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).~Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.~5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )~Each phase lasted 10 weeks."
212582|NCT01519271|P2|Participant Flow|Rivastigmine First Then Placebo|"5-10cm2 rivastigmine patch daily first in phase 1 and placebo patch daily in phase 2. Each phase lasted for 10 weeks.~Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.~5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )~Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine)."
212583|NCT01519271|P1|Participant Flow|Placebo First Then Rivastigmine|"Placebo patches placed on skin daily in Phase 1 and Rivastigmine 5-10cm2 patches in Phase 2. Each phase lasted for 10 weeks.~Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.~5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )~Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine)."
212584|NCT01519271|O2|Outcome|Rivastigmine|"Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.~5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )"
212585|NCT01519271|O1|Outcome|Placebo|Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).
212586|NCT01519271|O2|Outcome|Exelon Patch (Rivastigmine Transdermal System)|"Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.~5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )"
212587|NCT01519271|O1|Outcome|Placebo Patch|Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).
212588|NCT01519271|E2|Reported Event|Exelon Patch (Rivastigmine Transdermal System)|"Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.~5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )"
212589|NCT01519271|E1|Reported Event|Placebo Patch|Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).
212590|NCT01519245|B3|Baseline|Total|Total of all reporting groups
212591|NCT01519245|B2|Baseline|Placebo|Normal saline (70mL)
212592|NCT01519245|B1|Baseline|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
212593|NCT01519245|P2|Participant Flow|Placebo|Normal saline (70mL)
212594|NCT01519245|P1|Participant Flow|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
212595|NCT01519245|O2|Outcome|Placebo|Normal saline (70mL)
212596|NCT01519245|O1|Outcome|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
212597|NCT01519245|O2|Outcome|Placebo|Normal saline (70mL)
212598|NCT01519245|O1|Outcome|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
212599|NCT01519245|O2|Outcome|Placebo|Normal saline (70mL)
212600|NCT01519245|O1|Outcome|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
212601|NCT01519245|O2|Outcome|Placebo|"Normal saline (70mL)~Total duration that chest tubes were in-situ before removal = 21 hours (SD 2)"
212602|NCT01519245|O1|Outcome|Trial Drug|"Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)~Total duration that chest tubes were in-situ before removal = 20 hours (SD 3)"
212603|NCT01519245|E2|Reported Event|Placebo|Normal saline (70mL)
212604|NCT01519245|E1|Reported Event|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
212605|NCT01519206|B1|Baseline|Ultherapy Treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
212606|NCT01519206|P1|Participant Flow|Ultherapy Treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
212607|NCT01519206|O3|Outcome|Treated Subjects PSQ Data - 1 Year Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
212608|NCT01519206|O2|Outcome|Treated Subjects PSQ Data - 180 Days Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
212609|NCT01519206|O1|Outcome|Treated Subjects PSQ Data - 90 Days Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
212610|NCT01519206|O1|Outcome|Ultherapy Treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
212611|NCT01519206|O4|Outcome|Treated Subjects GAIS Data - 1 Year Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
212612|NCT01519206|O3|Outcome|Treated Subjects GAIS Data - 180 Days Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
212613|NCT01519206|O2|Outcome|Treated Subjects GAIS Data - 90 Days Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
212614|NCT01519206|O1|Outcome|Treated Subjects GAIS Data - 60 Days Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
212615|NCT01519206|O1|Outcome|Ultherapy Treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
212616|NCT01519206|E1|Reported Event|Ultherapy Treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
212617|NCT01519167|B3|Baseline|Total|Total of all reporting groups
212618|NCT01519167|B2|Baseline|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
212619|NCT01519167|B1|Baseline|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
212620|NCT01519167|P2|Participant Flow|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
212621|NCT01519167|P1|Participant Flow|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
212622|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
212623|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
212624|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
212625|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
212626|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
212627|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
212628|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
212629|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
212630|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
212631|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
212632|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
212633|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
212634|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
212635|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
212639|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
212640|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
212641|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
212642|NCT01519167|E2|Reported Event|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
212643|NCT01519167|E1|Reported Event|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
212644|NCT01519089|B3|Baseline|Total|Total of all reporting groups
212645|NCT01519089|B2|Baseline|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212646|NCT01519089|B1|Baseline|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212647|NCT01519089|P2|Participant Flow|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212648|NCT01519089|P1|Participant Flow|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212649|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212650|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212651|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212652|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212653|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212654|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212655|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212656|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212657|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212658|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212659|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212660|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212661|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212662|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212663|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212664|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212665|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212666|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212667|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212668|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212669|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212670|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212671|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212672|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212673|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212674|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212675|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212676|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212677|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212678|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212679|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212680|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212681|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212682|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212683|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212684|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212685|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212686|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212687|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212688|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212689|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212690|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212691|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212692|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212693|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212694|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212695|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212696|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212697|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212698|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212699|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212700|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212701|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212702|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212703|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212704|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212705|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212706|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212707|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212708|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212709|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212710|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212711|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212712|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212713|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212714|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212715|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212716|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212717|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212718|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212719|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212720|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212721|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212722|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212723|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212724|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212725|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212726|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212727|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212728|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212729|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212730|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212731|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212732|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212733|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212734|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212735|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212736|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212737|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212738|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212739|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212740|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212741|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212742|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212743|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212744|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212745|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212746|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212747|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212748|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212749|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212750|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212751|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212752|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212753|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212754|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212755|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212756|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212757|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212758|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212759|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212760|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
212761|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212762|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212763|NCT01519089|E3|Reported Event|Total|(=sum across Arm/Groups)
212764|NCT01519089|E2|Reported Event|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212765|NCT01519089|E1|Reported Event|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
212766|NCT01518946|B3|Baseline|Total|Total of all reporting groups
212767|NCT01518946|B2|Baseline|Midodrine HCl First, Then Placebo (Randomized Phase)|Midodrine hydrochloride dose at the subject's current dose level for the first intervention Day 2, then placebo for second intervention on Day 3.
212801|NCT01518257|B2|Baseline|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
212768|NCT01518946|B1|Baseline|Placebo First, Then Midodrine HCl (Randomized Phase)|Placebo for first intervention on Day 2, then Midodrine hydrochloride dose at the subject's current dose level for the second intervention on Day 3.
212769|NCT01518946|P3|Participant Flow|Midodrine HCl First, Then Placebo (Randomized Phase)|Midodrine hydrochloride dose at the subject's current dose level for the first intervention Day 2, then placebo for second intervention on Day 3.
212770|NCT01518946|P2|Participant Flow|Placebo First, Then Midodrine HCl (Randomized Phase)|Placebo for first intervention on Day 2, then Midodrine hydrochloride dose at the subject's current dose level for the second intervention on Day 3.
212771|NCT01518946|P1|Participant Flow|Midodrine HCl (Open-label Phase)|On the morning of Day -1, subjects took their usual morning dose of midodrine HCl, using their own midodrine HCl supplies at approximately the same time before rising that they would normally take their morning dose. On the morning of Day 1, subjects had their usual morning dose of midodrine HCl withheld.
212772|NCT01518946|O2|Outcome|Midodrine HCl|dose at the subject's current dose level
212773|NCT01518946|O1|Outcome|Placebo|single dose of matching placebo
212774|NCT01518946|E3|Reported Event|Midodrine HCl (Randomized Phase)|dose at the subject's current dose level
212775|NCT01518946|E2|Reported Event|Placebo (Randomized Phase)|single dose of matching placebo
212776|NCT01518946|E1|Reported Event|Midodrine HCl (Open-label Phase)|dose at the subject's current dose level
212777|NCT01518530|B1|Baseline|Patients With Chronic Neck Pain Treated With Occiflex|Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck.
212778|NCT01518530|P1|Participant Flow|Chronic Neck Pain Patients Treated With Occiflex|Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck.
212779|NCT01518530|O1|Outcome|Patients With Chronic Neck Pain Treated With Occiflex|Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck.
212780|NCT01518530|E1|Reported Event|Patients With Chronic Neck Pain Treated With Occiflex|Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck.
212781|NCT01518322|B1|Baseline|FeNO|All subjects will have their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements.
212782|NCT01518322|P1|Participant Flow|FeNO|All subjects will have their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements.
212783|NCT01518322|O1|Outcome|High FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and High FeNO per the American Thoracic Society (ATS) standards. For those aged 12 years or older, >50 ppb is high. For children under age 12 years, >35 ppb is high.
212784|NCT01518322|O3|Outcome|High FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and High FeNO per the American Thoracic Society (ATS) standards. For those aged 12 years or older, >50 ppb is high. For children under age 12 years, >35 ppb is high.
212785|NCT01518322|O2|Outcome|Intermediate FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and Intermediate FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, ≥20 ppb and ≤35 ppb is intermediate. For those aged 12 years or older, ≥25 ppb and ≤50 ppb.
212786|NCT01518322|O1|Outcome|Low FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and Low FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, <20 ppb is low. For those aged 12 years or older, <25 ppb is low.
212787|NCT01518322|O3|Outcome|High FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and High FeNO per the American Thoracic Society (ATS) standards. For those aged 12 years or older, >50 ppb is high. For children under age 12 years, >35 ppb is high
212788|NCT01518322|O2|Outcome|Intermediate FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and Intermediate FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, ≥20 ppb and ≤35 ppb is intermediate. For those aged 12 years or older, ≥25 ppb and ≤50 ppb.
212789|NCT01518322|O1|Outcome|Low FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and Low FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, <20 ppb is low. For those aged 12 years or older, <25 ppb is low.
212790|NCT01518322|O3|Outcome|High FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and High FeNO per the American Thoracic Society (ATS) standards. For those aged 12 years or older, >50 ppb is high. For children under age 12 years, >35 ppb is high.
212791|NCT01518322|O2|Outcome|Intermediate FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and intermediate FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, ≥20 ppb and ≤35 ppb is intermediate. For those aged 12 years or older, ≥25 ppb and ≤50 ppb.
212792|NCT01518322|O1|Outcome|Low FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and Low FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, <20 ppb is low. For those aged 12 years or older, <25 ppb is low.
212793|NCT01518322|E1|Reported Event|FeNO|All subjects will have their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements.
212794|NCT01518270|B1|Baseline|Healthy Females|Participant's eyelashes were photographed at one study visit.
212795|NCT01518270|P1|Participant Flow|Healthy Females|Participant's eyelashes were photographed at one study visit.
212796|NCT01518270|O1|Outcome|Healthy Females|Participant's eyelashes were photographed at one study visit.
212797|NCT01518270|O1|Outcome|Healthy Females|Participant's eyelashes were photographed at one study visit.
212798|NCT01518270|O1|Outcome|Healthy Females|Participant's eyelashes were photographed at one study visit.
212799|NCT01518270|E1|Reported Event|Healthy Females|Healthy Females
212802|NCT01518257|B1|Baseline|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
212803|NCT01518257|P2|Participant Flow|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
212804|NCT01518257|P1|Participant Flow|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
212805|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
212806|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
212807|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
212808|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
212809|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
212810|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
212811|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
212812|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
212813|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
212814|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
212815|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
212816|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
212817|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
212818|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
212819|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
212820|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
212821|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
212822|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
212823|NCT01518257|E2|Reported Event|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
212824|NCT01518257|E1|Reported Event|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
212825|NCT01518244|B1|Baseline|AZARGA®|Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
212826|NCT01518244|P1|Participant Flow|AZARGA®|Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
212827|NCT01518244|O1|Outcome|AZARGA®|Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
212828|NCT01518244|O1|Outcome|AZARGA®|Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
212829|NCT01518244|E1|Reported Event|AZARGA®|Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
212830|NCT01518192|B4|Baseline|Total|Total of all reporting groups
212831|NCT01518192|B3|Baseline|Controls|To obtain a control group from the same geographical area, each patient was asked if he/she had a family member or friend who was within 5 years of his/her age and had no history of Lyme disease (two of the potential control subjects were excluded due to this reason), and was not pregnant, lactating or immunocompromised.
212832|NCT01518192|B2|Baseline|Cefuroxime Axetil|"Patients were assigned to receive a 15-day oral treatment with either doxycycline 100 mg or cefuroxime axetil 500 mg twice daily, by alternating treatment regimens each week.~Evaluations:~At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured as previously described; this procedure was repeated 2-3 months later in patients with a positive culture."
212833|NCT01518192|B1|Baseline|Doxycycline|"Patients were assigned to receive a 15-day oral treatment with either doxycycline 100 mg or cefuroxime axetil 500 mg twice daily, by alternating treatment regimens each week.~Evaluations:~At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured as previously described; this procedure was repeated 2-3 months later in patients with a positive culture."
212834|NCT01518192|P3|Participant Flow|Controls|patients' family members or friends without a history of Lyme disease
212835|NCT01518192|P2|Participant Flow|Cefuroxime Axetil|"Patients were assigned to receive a 15-day oral treatment with cefuroxime axetil 500 mg twice daily.~At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture."
212836|NCT01518192|P1|Participant Flow|Doxycycline|"Patients were assigned to receive a 15-day oral treatment with doxycycline 100 mg twice daily.~At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture."
212837|NCT01518192|O2|Outcome|Controls|controls with selected subjective symptoms at 12 months post inclusion
212838|NCT01518192|O1|Outcome|Patients|patients with selected subjective symptoms at 12 months post inclusion
212839|NCT01518192|O2|Outcome|Controls|controls with new or increased symptoms since erythema migrans at 12 months post inclusion
212840|NCT01518192|O1|Outcome|Patients|patients with new or increased symptoms since erythema migrans at 12 months post inclusion
212841|NCT01518192|O2|Outcome|Cefuroxime Axetil|cefuroxime axetil 500 mg twice daily for 15 days
212842|NCT01518192|O1|Outcome|Doxycycline|doxycycline 100 mg twice daily for 15 days
212843|NCT01518192|O2|Outcome|Cefuroximew Axetil|cefuroxime axetil 500 mg twice daily for 15 days
212844|NCT01518192|O1|Outcome|Doxycycline|doxycycline 100 mg twice daily for 15 days
212845|NCT01518192|O2|Outcome|Cefuroxime Axetil|cefuroxime axetil 500 mg twice daily for 15 days
212846|NCT01518192|O1|Outcome|Doxycycline|doxycycline 100 mg twice daily for 15 days
212847|NCT01518192|O2|Outcome|Cefuroxime Axetil|cefuroxime axetil 500 mg twice daily for 15 days
212848|NCT01518192|O1|Outcome|Doxycycline|doxycycline 100 mg twice daily for 15 days
212849|NCT01518192|O2|Outcome|Controls|controls with new or increased symptoms since enrollment at 6 months post inclusion
212850|NCT01518192|O1|Outcome|Patients|patients with new or increased symptoms since erythema migrans at 6 months post inclusion
212851|NCT01518192|O2|Outcome|Cefuroxime Axetil|cefuroxime axetil 500 mg twice daily for 15 days
212852|NCT01518192|O1|Outcome|Doxycycline|doxycycline 100 mg twice daily for 15 days
212853|NCT01518192|E3|Reported Event|Controls|patients' family members or friends without a history of Lyme disease
212854|NCT01518192|E2|Reported Event|Cefuroxime Axetil|"Patients were assigned to receive a 15-day oral treatment with cefuroxime axetil 500 mg twice daily.~At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture."
212855|NCT01518192|E1|Reported Event|Doxycycline|"Patients were assigned to receive a 15-day oral treatment with doxycycline 100 mg twice daily.~At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture."
212856|NCT01518153|B1|Baseline|Stem Cell Transplant + Donor Lymphocyte Infusion|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1 x 10^6 CD3+ cells/kg or 3 x 10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
212857|NCT01518153|P3|Participant Flow|High Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 3*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
212858|NCT01518153|P2|Participant Flow|Low Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
212859|NCT01518153|P1|Participant Flow|Stem Cell Infusion|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused.
212860|NCT01518153|O1|Outcome|Stem Cell Transplant + Donor Lymphocyte Infusion|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1 x 10^6 CD3+ cells/kg or 3 x 10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
212861|NCT01518153|O2|Outcome|High Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 3*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
212862|NCT01518153|O1|Outcome|Low Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
212863|NCT01518153|E3|Reported Event|High Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 3*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
212864|NCT01518153|E2|Reported Event|Low Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
212865|NCT01518153|E1|Reported Event|Stem Cell Infusion|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused.
212866|NCT01517984|B4|Baseline|Total|Total of all reporting groups
212867|NCT01517984|B3|Baseline|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
212868|NCT01517984|B2|Baseline|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
212869|NCT01517984|B1|Baseline|Transplanted, But Not Randomized|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for up to 8 months and deemed ineligible for randomization or terminated for other reasons.
212870|NCT01517984|P4|Participant Flow|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where they continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
212871|NCT01517984|P3|Participant Flow|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
212872|NCT01517984|P2|Participant Flow|Transplanted, Not Randomized|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for up to 8 months and deemed ineligible for randomization or terminated for other reasons.
212873|NCT01517984|P1|Participant Flow|Enrolled, Not Transplanted|These participants were consented and enrolled into the study, but did receive a living-donor kidney allograft transplant as specified by the protocol.
212874|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
213082|NCT01517282|P3|Participant Flow|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
212875|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
212876|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
212877|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
212878|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
212879|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
212880|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
212881|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
212882|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
212883|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
212915|NCT01517867|E1|Reported Event|Intervention Chicago Parent Program Arm|"The Chicago Parent Program is a 12-session group-based parenting skills training program~Chicago Parent Program: The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems"
212884|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
212885|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
212886|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
212887|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
212888|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
212889|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
212890|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
212891|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
212892|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
212916|NCT01517750|B5|Baseline|Total|Total of all reporting groups
212917|NCT01517750|B4|Baseline|APAP Without Humidification + High Risks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
212893|NCT01517984|E3|Reported Event|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where they continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
212894|NCT01517984|E2|Reported Event|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
212895|NCT01517984|E1|Reported Event|Transplanted, But Not Randomized|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for up to 8 months and deemed ineligible for randomization or terminated for other reasons.
212896|NCT01517893|B3|Baseline|Total|Total of all reporting groups
212897|NCT01517893|B2|Baseline|Placebo Arm|Placebo: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
212898|NCT01517893|B1|Baseline|Intervention Arm|"Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated~Simvastatin: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated"
212899|NCT01517893|P2|Participant Flow|Placebo Arm|Placebo: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
212900|NCT01517893|P1|Participant Flow|Intervention Arm|"Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated~Simvastatin: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated"
212901|NCT01517893|O2|Outcome|Placebo Arm|Placebo: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
212902|NCT01517893|O1|Outcome|Intervention Arm|"Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated~Simvastatin: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated"
212903|NCT01517893|E2|Reported Event|Placebo Arm|Placebo: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
212904|NCT01517893|E1|Reported Event|Intervention Arm|"Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated~Simvastatin: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated"
212905|NCT01517867|B3|Baseline|Total|Total of all reporting groups
212906|NCT01517867|B2|Baseline|Parent-Child Interaction Therapy|"Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems~Parent-Child Interaction Therapy: Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems"
212907|NCT01517867|B1|Baseline|Intervention Chicago Parent Program Arm|"The Chicago Parent Program is a 12-session group-based parenting skills training program~Chicago Parent Program: The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems"
212908|NCT01517867|P2|Participant Flow|Parent-Child Interaction Therapy|"Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems~Parent-Child Interaction Therapy: Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems"
212909|NCT01517867|P1|Participant Flow|Intervention Chicago Parent Program Arm|"The Chicago Parent Program is a 12-session group-based parenting skills training program~Chicago Parent Program: The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems"
212910|NCT01517867|O2|Outcome|Parent-Child Interaction Therapy|"Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems~Parent-Child Interaction Therapy: Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems"
212911|NCT01517867|O1|Outcome|Intervention Chicago Parent Program Arm|"The Chicago Parent Program is a 12-session group-based parenting skills training program~Chicago Parent Program: The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems"
212912|NCT01517867|O2|Outcome|Parent-Child Interaction Therapy|"Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems~Parent-Child Interaction Therapy: Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems"
212913|NCT01517867|O1|Outcome|Intervention Chicago Parent Program Arm|"The Chicago Parent Program is a 12-session group-based parenting skills training program~Chicago Parent Program: The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems"
212914|NCT01517867|E2|Reported Event|Parent-Child Interaction Therapy|"Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems~Parent-Child Interaction Therapy: Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems"
212918|NCT01517750|B3|Baseline|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
212919|NCT01517750|B2|Baseline|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
212920|NCT01517750|B1|Baseline|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
212921|NCT01517750|P4|Participant Flow|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ (continuous positive airway pressure) without Thermosmart heated tube with patients who are classified to have a high risks (major complaints classified as a NPC score more than 9) of nasopharyngeal problems.
212922|NCT01517750|P3|Participant Flow|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ (continuous positive airway pressure) with Thermosmart heated tube with patients who are classified to have a high risks (major complaints classified as a NPC score more than 9) of nasopharyngeal problems.
212923|NCT01517750|P2|Participant Flow|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ (continuous positive airway pressure) with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints classified as a NPC score equal or less than 9) of nasopharyngeal problems.
212924|NCT01517750|P1|Participant Flow|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ (continuous positive airway pressure) without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints classified as a NPC score equal or less than 9) of nasopharyngeal problems.
212925|NCT01517750|O4|Outcome|WIthout Previous ENT Surgeries + WIthout Humidification|
212926|NCT01517750|O3|Outcome|Without Previous ENT Surgeries + Humidification|
212927|NCT01517750|O2|Outcome|Previous ENT Surgeries + Without Humidification|
212928|NCT01517750|O1|Outcome|Previous ENT Surgeries + Humidification|
212929|NCT01517750|O4|Outcome|WIthout Previous ENT Surgeries + WIthout Humidification|
212930|NCT01517750|O3|Outcome|Without Previous ENT Surgeries + Humidification|
212931|NCT01517750|O2|Outcome|Previous ENT Surgeries + Without Humidification|
212932|NCT01517750|O1|Outcome|Previous ENT Surgeries + Humidification|
212933|NCT01517750|O4|Outcome|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
212934|NCT01517750|O3|Outcome|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
212935|NCT01517750|O2|Outcome|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
212936|NCT01517750|O1|Outcome|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
212937|NCT01517750|O4|Outcome|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
212938|NCT01517750|O3|Outcome|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
212939|NCT01517750|O2|Outcome|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
212940|NCT01517750|O1|Outcome|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
212941|NCT01517750|O4|Outcome|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
212942|NCT01517750|O3|Outcome|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
212943|NCT01517750|O2|Outcome|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
212944|NCT01517750|O1|Outcome|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
212945|NCT01517750|O4|Outcome|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
212946|NCT01517750|O3|Outcome|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
212947|NCT01517750|O2|Outcome|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
212948|NCT01517750|O1|Outcome|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
212949|NCT01517750|E4|Reported Event|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
212950|NCT01517750|E3|Reported Event|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
212951|NCT01517750|E2|Reported Event|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
212952|NCT01517750|E1|Reported Event|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
213080|NCT01517282|B1|Baseline|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
212953|NCT01517529|B1|Baseline|10 Hepatitis C Infected Subjects|10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.
212954|NCT01517529|P1|Participant Flow|10 Hepatitis C Infected Subjects|10 chronically HCV-infected patients who failed the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.
212955|NCT01517529|O1|Outcome|10 Hepatitis C Infected Subjects|10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.
212956|NCT01517529|O1|Outcome|10 Hepatitis C Infected Subjects|10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.
212957|NCT01517529|E1|Reported Event|10 Hepatitis C Infected Subjects|10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.
212958|NCT01517412|B3|Baseline|Total|Total of all reporting groups
212959|NCT01517412|B2|Baseline|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
212960|NCT01517412|B1|Baseline|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
212961|NCT01517412|P2|Participant Flow|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
212962|NCT01517412|P1|Participant Flow|Lixisenatide Main Meal|Lixisenatide 10 mcg subcutaneous (SC) injection once daily (QD) within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
212963|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
212964|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
212965|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
212966|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
212967|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
212968|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
212969|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
212970|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
212971|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
212972|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
212973|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
212974|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
212975|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
212976|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
212977|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
212978|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
212979|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
212980|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
212981|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
212982|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
212983|NCT01517412|E2|Reported Event|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
212984|NCT01517412|E1|Reported Event|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
212985|NCT01517373|B6|Baseline|Total|Total of all reporting groups
212986|NCT01517373|B5|Baseline|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
212987|NCT01517373|B4|Baseline|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
212988|NCT01517373|B3|Baseline|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
212989|NCT01517373|B2|Baseline|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
212990|NCT01517373|B1|Baseline|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
212991|NCT01517373|P6|Participant Flow|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
212992|NCT01517373|P5|Participant Flow|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
212993|NCT01517373|P4|Participant Flow|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
212994|NCT01517373|P3|Participant Flow|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
212995|NCT01517373|P2|Participant Flow|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
212996|NCT01517373|P1|Participant Flow|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
212997|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
212998|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
212999|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213000|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213001|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213002|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213003|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213004|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213005|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213006|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213007|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213008|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213009|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213010|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213011|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213012|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213013|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213014|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213015|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213081|NCT01517282|P4|Participant Flow|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
213016|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213017|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213018|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213019|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213020|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213021|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213022|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213023|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213024|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213025|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213026|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213027|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213028|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213029|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213030|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213031|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213032|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213033|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213034|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213035|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213036|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213037|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213038|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213039|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213040|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213041|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213042|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213043|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213044|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213045|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213046|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213047|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213048|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213049|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213050|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213051|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213052|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213053|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213054|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213055|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213056|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213057|NCT01517373|E6|Reported Event|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213058|NCT01517373|E5|Reported Event|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213059|NCT01517373|E4|Reported Event|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213060|NCT01517373|E3|Reported Event|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213061|NCT01517373|E2|Reported Event|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
213062|NCT01517373|E1|Reported Event|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
213063|NCT01517295|B3|Baseline|Total|Total of all reporting groups
213064|NCT01517295|B2|Baseline|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
213065|NCT01517295|B1|Baseline|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
213066|NCT01517295|P2|Participant Flow|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
213067|NCT01517295|P1|Participant Flow|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
213068|NCT01517295|O2|Outcome|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
213069|NCT01517295|O1|Outcome|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
213070|NCT01517295|O2|Outcome|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
213071|NCT01517295|O1|Outcome|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
213072|NCT01517295|O2|Outcome|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
213073|NCT01517295|O1|Outcome|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
213074|NCT01517295|E2|Reported Event|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
213075|NCT01517295|E1|Reported Event|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
213076|NCT01517282|B5|Baseline|Total|Total of all reporting groups
213077|NCT01517282|B4|Baseline|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
213078|NCT01517282|B3|Baseline|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213079|NCT01517282|B2|Baseline|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213083|NCT01517282|P2|Participant Flow|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213084|NCT01517282|P1|Participant Flow|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213085|NCT01517282|O4|Outcome|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
213086|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213087|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213088|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213089|NCT01517282|O4|Outcome|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
213090|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213091|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213092|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213093|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213094|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213095|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213096|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213097|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213098|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213099|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213100|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213101|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213102|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213103|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213104|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213105|NCT01517282|O4|Outcome|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
213106|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213107|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213108|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213109|NCT01517282|O4|Outcome|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
213110|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213111|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213112|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213113|NCT01517282|E4|Reported Event|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
213114|NCT01517282|E3|Reported Event|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213115|NCT01517282|E2|Reported Event|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213116|NCT01517282|E1|Reported Event|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
213117|NCT01517178|B1|Baseline|Intention-to-treat Analysis Set|
213118|NCT01517178|P2|Participant Flow|New Ostomy Base Plate - Standard Care|Subjects first test New ostomy base plate then Standard Care.
213119|NCT01517178|P1|Participant Flow|Standard Care - New Ostomy Base Plate|Subjects first test Standard Care then New ostomy base plate.
213120|NCT01517178|O2|Outcome|New Ostomy Base Plate|
213121|NCT01517178|O1|Outcome|Standard Care Base Plate|
213122|NCT01517178|E2|Reported Event|New Ostomy Base Plate|Safety population includes subjects allocated to run-in period and test period.
213123|NCT01517178|E1|Reported Event|Standard Care Base Plate|Safety population includes subjects allocated to test period (no run-in period)
213124|NCT01517074|B1|Baseline|Sirolimus|Participants will receive a15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If greater than two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg). Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period).
213125|NCT01517074|P1|Participant Flow|Sirolimus|Participants will receive a15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If greater than two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg). Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period).
213188|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213126|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
213127|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
213128|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
213129|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
213130|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
213131|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
213132|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
213133|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
213134|NCT01517074|E1|Reported Event|Sirolimus|Participants will receive a15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If greater than two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg). Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period).
213135|NCT01516970|B3|Baseline|Total|Total of all reporting groups
213183|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213184|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213136|NCT01516970|B2|Baseline|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual SmPCs at the discretion of either the treating physician or Investigator.
213137|NCT01516970|B1|Baseline|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
213138|NCT01516970|P2|Participant Flow|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual SmPCs at the discretion of either the treating physician or Investigator.
213139|NCT01516970|P1|Participant Flow|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
213140|NCT01516970|O2|Outcome|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
213141|NCT01516970|O1|Outcome|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
213142|NCT01516970|O2|Outcome|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
213143|NCT01516970|O1|Outcome|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
213144|NCT01516970|O2|Outcome|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
213145|NCT01516970|O1|Outcome|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
213146|NCT01516970|O2|Outcome|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
213147|NCT01516970|O1|Outcome|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
213185|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213186|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213187|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213148|NCT01516970|E2|Reported Event|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual SmPCs at the discretion of either the treating physician or Investigator.
213149|NCT01516970|E1|Reported Event|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
213150|NCT01516892|B1|Baseline|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
213151|NCT01516892|P1|Participant Flow|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
213152|NCT01516892|O1|Outcome|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
213153|NCT01516892|O1|Outcome|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
213154|NCT01516892|O1|Outcome|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
213155|NCT01516892|E1|Reported Event|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
213156|NCT01516879|B3|Baseline|Total|Total of all reporting groups
213157|NCT01516879|B2|Baseline|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213158|NCT01516879|B1|Baseline|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213159|NCT01516879|P2|Participant Flow|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213160|NCT01516879|P1|Participant Flow|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213161|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213162|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213163|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213164|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213165|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213166|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213167|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213168|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213169|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213170|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213171|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213172|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213173|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213174|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213175|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213176|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213177|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213178|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213179|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213180|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213181|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213182|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213189|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213190|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213191|NCT01516879|E2|Reported Event|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213192|NCT01516879|E1|Reported Event|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
213193|NCT01516749|B1|Baseline|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.~anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
213194|NCT01516749|P1|Participant Flow|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.~anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
213195|NCT01516749|O1|Outcome|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.~anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
213196|NCT01516749|O1|Outcome|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.~anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
213197|NCT01516749|O1|Outcome|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.~anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
213198|NCT01516749|O1|Outcome|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.~anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
213199|NCT01516749|E1|Reported Event|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.~anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
213200|NCT01516736|B3|Baseline|Total|Total of all reporting groups
213201|NCT01516736|B2|Baseline|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
213202|NCT01516736|B1|Baseline|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application."
213203|NCT01516736|P2|Participant Flow|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
213204|NCT01516736|P1|Participant Flow|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application."
213205|NCT01516736|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
213206|NCT01516736|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application."
213207|NCT01516736|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
213208|NCT01516736|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application."
213209|NCT01516736|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
213210|NCT01516736|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application."
213211|NCT01516736|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
213212|NCT01516736|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application."
213213|NCT01516736|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
214160|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
213214|NCT01516736|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application."
213215|NCT01516736|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
213216|NCT01516736|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application."
213217|NCT01516736|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
213218|NCT01516736|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application."
213219|NCT01516736|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
213220|NCT01516736|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application."
213221|NCT01516736|E2|Reported Event|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
213222|NCT01516736|E1|Reported Event|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application."
213223|NCT01516632|B3|Baseline|Total|Total of all reporting groups
213224|NCT01516632|B2|Baseline|The Control Group|Control group participants received a text-messaging program that was similar to the intervention program on the number of text messages received per day across the 6 weeks. Message content was aimed at improving one’s sleep and exercise habits within the context of how it would help the participant quit smoking. Messages were not tailored based on quitting stage (e.g., Pre-Quit vs. Early Quit) nor were Text Buddy and Text Crave components available to this group.
213225|NCT01516632|B1|Baseline|Smoking Cessation Text Messaging|6-week smoking cessation program delivered via daily text messages. Stop My Smoking (SMS) USA is a text messaging–based smoking cessation program tailored to the experiences of young adult smokers. Content was tailored based on participant's stage of quitting (i.e. pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. The intervention group had access to Text Buddy (another person in the program that a participant was assigned to so they could text one another for support anonymously and Text Crave (immediate, on demand messages aimed at helping the participant through a craving).
213226|NCT01516632|P2|Participant Flow|Attention-Matched Control Group|Control group participants received a text-messaging program that was similar to the intervention program on the number of text messages received per day across the 6 weeks. Message content was aimed at improving one’s sleep and exercise habits within the context of how it would help the participant quit smoking. Messages were not tailored based on quitting stage (e.g., Pre-Quit vs. Early Quit) nor were Text Buddy and Text Crave components available to this group.
213227|NCT01516632|P1|Participant Flow|Smoking Cessation Text Messaging|6-week smoking cessation program delivered via daily text messages. Stop My Smoking (SMS) USA is a text messaging–based smoking cessation program tailored to the experiences of young adult smokers. Content was tailored based on participant's stage of quitting (i.e. pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. The intervention group had access to Text Buddy (another person in the program that a participant was assigned to so they could text one another for support anonymously and Text Crave (immediate, on demand messages aimed at helping the participant through a craving).
213228|NCT01516632|O2|Outcome|Attention-Matched Control Group|Control group participants received a text-messaging program that was similar to the intervention program on the number of text messages received per day across the 6 weeks. Message content was aimed at improving one’s sleep and exercise habits within the context of how it would help the participant quit smoking. Messages were not tailored based on quitting stage (e.g., Pre-Quit vs. Early Quit) nor were Text Buddy and Text Crave components available to this group.
213229|NCT01516632|O1|Outcome|Smoking Cessation Text Messaging|6-week smoking cessation program delivered via daily text messages. Stop My Smoking (SMS) USA is a text messaging–based smoking cessation program tailored to the experiences of young adult smokers. Content was tailored based on participant's stage of quitting (i.e. pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. The intervention group had access to Text Buddy (another person in the program that a participant was assigned to so they could text one another for support anonymously and Text Crave (immediate, on demand messages aimed at helping the participant through a craving).
213259|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
213260|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
213230|NCT01516632|O2|Outcome|Attention-Matched Control Group|Control group participants received a text-messaging program that was similar to the intervention program on the number of text messages received per day across the 6 weeks. Message content was aimed at improving one’s sleep and exercise habits within the context of how it would help the participant quit smoking. Messages were not tailored based on quitting stage (e.g., Pre-Quit vs. Early Quit) nor were Text Buddy and Text Crave components available to this group.
213231|NCT01516632|O1|Outcome|Smoking Cessation Text Messaging|6-week smoking cessation program delivered via daily text messages. Stop My Smoking (SMS) USA is a text messaging–based smoking cessation program tailored to the experiences of young adult smokers. Content was tailored based on participant's stage of quitting (i.e. pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. The intervention group had access to Text Buddy (another person in the program that a participant was assigned to so they could text one another for support anonymously and Text Crave (immediate, on demand messages aimed at helping the participant through a craving).
213232|NCT01516632|O2|Outcome|Attention Matched Control|"Messages aimed at improving one's sleep and increasing one's fitness, along with general messages about the most well known health dangers of smoking. Messages sent on the same schedule as the intervention group.~SMS (Stop my Smoking) USA: Intervention participants receive text messages daily pre-and post-quit. Everyone receives messages 14 days prior to the Quit day, and through the day after Quit. Then, participants are 'pathed' to particular messages based upon their self-reported smoking status at Day 2 and Day 7 post quit, respectively. Those who are successful at quitting receive messages aimed at relapse prevention whereas those who have slipped receive messages aimed at getting the person to recommit to quitting and trying again."
213233|NCT01516632|O1|Outcome|Smoking Cesssation Via Text Messaging|"The 6-week smoking cessation program~SMS (Stop my Smoking) USA: Intervention participants receive text messages daily pre-and post-quit. Everyone receives messages 14 days prior to the Quit day, and through the day after Quit. Then, participants are 'pathed' to particular messages based upon their self-reported smoking status at Day 2 and Day 7 post quit, respectively. Those who are successful at quitting receive messages aimed at relapse prevention whereas those who have slipped receive messages aimed at getting the person to recommit to quitting and trying again."
213234|NCT01516632|E2|Reported Event|Attention-Matched Control Group|Control group participants received a text-messaging program that was similar to the intervention program on the number of text messages received per day across the 6 weeks. Message content was aimed at improving one’s sleep and exercise habits within the context of how it would help the participant quit smoking. Messages were not tailored based on quitting stage (e.g., Pre-Quit vs. Early Quit) nor were Text Buddy and Text Crave components available to this group.
213235|NCT01516632|E1|Reported Event|Smoking Cessation Text Messaging|6-week smoking cessation program delivered via daily text messages. Stop My Smoking (SMS) USA is a text messaging–based smoking cessation program tailored to the experiences of young adult smokers. Content was tailored based on participant's stage of quitting (i.e. pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. The intervention group had access to Text Buddy (another person in the program that a participant was assigned to so they could text one another for support anonymously and Text Crave (immediate, on demand messages aimed at helping the participant through a craving).
213236|NCT01516437|B5|Baseline|Total|Total of all reporting groups
213237|NCT01516437|B4|Baseline|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
213238|NCT01516437|B3|Baseline|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
213239|NCT01516437|B2|Baseline|HS Group|Healthy smokers aged between 45-75 years
213240|NCT01516437|B1|Baseline|HNS Group|Healthy non-smokers aged between 45-75 years
213241|NCT01516437|P4|Participant Flow|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
213242|NCT01516437|P3|Participant Flow|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
213243|NCT01516437|P2|Participant Flow|HS Group|Healthy smokers aged between 45-75 years
213244|NCT01516437|P1|Participant Flow|HNS Group|Healthy non-smokers aged between 45-75 years
213245|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
213246|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
213247|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
213248|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
213249|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
213250|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
213251|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
213252|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
213253|NCT01516437|O2|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
213254|NCT01516437|O1|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
213255|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
213256|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
213257|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
213258|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
213263|NCT01516437|O2|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
213264|NCT01516437|O1|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
213265|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
213266|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
213267|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
213268|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
213269|NCT01516437|O2|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
213270|NCT01516437|O1|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
213271|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
213272|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
213273|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
213274|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
213275|NCT01516437|O2|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
213276|NCT01516437|O1|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
213277|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
213278|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
213279|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
213280|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
213281|NCT01516437|O2|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
213282|NCT01516437|O1|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
213283|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
213284|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
213285|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
213286|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
213287|NCT01516437|O2|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
213288|NCT01516437|O1|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
213289|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
213290|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
213291|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
213292|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
213293|NCT01516437|E4|Reported Event|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
213294|NCT01516437|E3|Reported Event|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
213295|NCT01516437|E2|Reported Event|HS Group|Healthy smokers aged between 45-75 years
213296|NCT01516437|E1|Reported Event|HNS Group|Healthy non-smokers aged between 45-75 years
213297|NCT01516268|B3|Baseline|Total|Total of all reporting groups
213298|NCT01516268|B2|Baseline|Control Group|In control group we add 1cc salin to 20cc bupivacain in TAP block
213299|NCT01516268|B1|Baseline|Sufentanyl Group|IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block
213300|NCT01516268|P2|Participant Flow|Control Group|In control group we add 1cc salin to 20cc bupivacain in TAP block
213301|NCT01516268|P1|Participant Flow|Sufentanyl Group|IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block
213302|NCT01516268|O2|Outcome|Control Group|In control group we add 1cc salin to 20cc bupivacain in TAP block
213303|NCT01516268|O1|Outcome|Sufentanyl Group|IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block
213304|NCT01516268|E2|Reported Event|Control Group|In control group we add 1cc salin to 20cc bupivacain in TAP block
213305|NCT01516268|E1|Reported Event|Sufentanyl Group|IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block
213306|NCT01516034|B1|Baseline|Treatment|Cupola tattoo removal treatment
213307|NCT01516034|P1|Participant Flow|Treatment|Cupola tattoo removal treatment
213308|NCT01516034|O1|Outcome|Treatment|Cupola tattoo removal treatment
213309|NCT01516034|E1|Reported Event|Treatment|Cupola tattoo removal treatment
213310|NCT01516008|B4|Baseline|Total|Total of all reporting groups
213311|NCT01516008|B3|Baseline|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
214161|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
213312|NCT01516008|B2|Baseline|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
213313|NCT01516008|B1|Baseline|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
213314|NCT01516008|P3|Participant Flow|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
213315|NCT01516008|P2|Participant Flow|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
213316|NCT01516008|P1|Participant Flow|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
213317|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
213318|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
213319|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
213320|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
213321|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
213322|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
213323|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
213324|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
213325|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
213326|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
213327|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
213328|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
213329|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
213330|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
213331|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
213332|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
213333|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
213334|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
213335|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
213336|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
213337|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
213338|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
213339|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
213340|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
213341|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
213342|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
213343|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
213344|NCT01516008|E3|Reported Event|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
213345|NCT01516008|E2|Reported Event|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
213346|NCT01516008|E1|Reported Event|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
213347|NCT01515956|B1|Baseline|BMN110 2.0 mg/kg/Week|2.0 mg/kg/week
213348|NCT01515956|P1|Participant Flow|BMN110 2.0 mg/kg/Week|Weekly intravenous infusions of BMN 110 at a dose of 2.0 mg/kg for 52 consecutive weeks. Each infusion will be administered over a period of approximately 4 hours.
213349|NCT01515956|O1|Outcome|BMN110 2.0 mg/kg/Week|Weekly intravenous infusions of BMN 110 at a dose of 2.0 mg/kg for 52 consecutive weeks. Each infusion will be administered over a period of approximately 4 hours.
213350|NCT01515956|O1|Outcome|BMN110 2.0 mg/kg/Week|Weekly intravenous infusions of BMN 110 at a dose of 2.0 mg/kg for 52 consecutive weeks. Each infusion will be administered over a period of approximately 4 hours.
213351|NCT01515956|O1|Outcome|BMN110 2.0 mg/kg/Week|BMN110 2.0 mg/kg/week
213352|NCT01515956|E1|Reported Event|BMN110 2.0 mg/kg/Week|BMN110 2.0 mg/kg/week
213353|NCT01515943|B4|Baseline|Total|Total of all reporting groups
213365|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213366|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213367|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
214162|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
213354|NCT01515943|B3|Baseline|Placebo|"The placebo group will be assigned placebo home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.~Placebo home-based computer vergence/accommodative therapy: At enrollment, subjects will be prescribed either 5 minutes/day (NTP group) or 15 minutes/day (Placebo group) of placebo home-based computer therapy for 5 days/week during the 12 week treatment phase. Placebo computer-based therapy will be provided by the Home Therapy System (HTS) computer software. The vergence procedures are similar to the active version, however, the tasks will be modified to ensure no demand on the vergence system and no accommodative therapy is included in the placebo version. Please refer to the procedures manual for further details.~Placebo yoked prism flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5"
213355|NCT01515943|B2|Baseline|Near Target Push-up (NTP)|"The NTP group will be assigned placebo home-based computer vergence/accommodative therapy (5 minutes/day) plus near target push-ups (15 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.~Near target push-ups: At enrollment, subjects will be prescribed 15 minutes/day (3 sessions of 5 minutes each) of near target push-ups (NTP) for 5 days/week during the 12-week treatment phase. An alphabet pencil will be used as the target and an index card placed in the background will provide physiological diplopia control. With the pencil positioned at arm's length directly between the subject's eyes, the subject will slowly bring the pencil toward his/her nose while focusing on the small letter on the pencil. When the subject is no longer able to maintain a single image of the pencil, he/she will slowly move the target away from the nose until the pencil becomes single again. This procedure will be repeated several times. Please refer to the pr"
213356|NCT01515943|B1|Baseline|Computer-based Therapy (CBT)|"The CBT group will be assigned active home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.~Active home-based computer vergence/accommodative therapy: At enrollment, subjects will be prescribed 15 minutes/day of active home-based computer therapy for 5 days/week during the 12 week treatment phase. Active home-based computer therapy will be provided the Home Therapy System (HTS) computer software and will include both fusional vergence and accommodative therapy. Subjects will perform the computer therapy while wearing red/blue glasses and accommodative therapy will be performed using the HTS accommodative flippers. Please refer to the procedures manual for further details.~Placebo yoked prism flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5 days/week during the 12 week treatment"
213357|NCT01515943|P3|Participant Flow|Placebo|"The placebo group will be assigned placebo home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.~Placebo home-based computer vergence/accommodative therapy: At enrollment, subjects will be prescribed either 5 minutes/day (NTP group) or 15 minutes/day (Placebo group) of placebo home-based computer therapy for 5 days/week during the 12 week treatment phase. Placebo computer-based therapy will be provided by the Home Therapy System (HTS) computer software. The vergence procedures are similar to the active version, however, the tasks will be modified to ensure no demand on the vergence system and no accommodative therapy is included in the placebo version. Please refer to the procedures manual for further details.~Placebo yoked prism flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5"
213358|NCT01515943|P2|Participant Flow|Near Target Push-up (NTP)|"The NTP group will be assigned placebo home-based computer vergence/accommodative therapy (5 minutes/day) plus near target push-ups (15 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.~Near target push-ups: At enrollment, subjects will be prescribed 15 minutes/day (3 sessions of 5 minutes each) of near target push-ups (NTP) for 5 days/week during the 12-week treatment phase. An alphabet pencil will be used as the target and an index card placed in the background will provide physiological diplopia control. With the pencil positioned at arm's length directly between the subject's eyes, the subject will slowly bring the pencil toward his/her nose while focusing on the small letter on the pencil. When the subject is no longer able to maintain a single image of the pencil, he/she will slowly move the target away from the nose until the pencil becomes single again. This procedure will be repeated several times."
213359|NCT01515943|P1|Participant Flow|Computer-based Therapy (CBT)|"The CBT group will be assigned active home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.~Active home-based computer vergence/accommodative therapy: At enrollment, subjects will be prescribed 15 minutes/day of active home-based computer therapy for 5 days/week during the 12 week treatment phase. Active home-based computer therapy will be provided the Home Therapy System (HTS) computer software and will include both fusional vergence and accommodative therapy. Subjects will perform the computer therapy while wearing red/blue glasses and accommodative therapy will be performed using the HTS accommodative flippers. Please refer to the procedures manual for further details.~Placebo yoked prism flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5 days/week during the 12 week treatment"
213360|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213361|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
213362|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213363|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213364|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
213554|NCT01515189|O1|Outcome|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
213368|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213369|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213370|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
213371|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213372|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213373|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
213374|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213375|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213376|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
213377|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213378|NCT01515943|O2|Outcome|HB-C (Did Not Complete Computer-based Therapy Program)|Participants in the HB-C treatment group who did not complete the computer vergence/accommodative therapy (CVAT) program at 12 weeks, defined as achieving <15 stars for the jump vergence exercise.
213379|NCT01515943|O1|Outcome|HB-C (Completed Computer-based Therapy Program)|Participants in the HB-C treatment group who completed the computer vergence/accommodative therapy (CVAT) program at 12 weeks, defined as achieving at least 15 stars for the jump vergence exercise).
213380|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213381|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
213382|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213383|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213384|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
213385|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213386|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213387|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
213388|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213389|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213390|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
213391|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213392|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213393|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
213394|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213395|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
215035|NCT01510158|O2|Outcome|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
213396|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
213397|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213398|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213399|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
213400|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213401|NCT01515943|E3|Reported Event|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213402|NCT01515943|E2|Reported Event|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
213403|NCT01515943|E1|Reported Event|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
213404|NCT01515891|B1|Baseline|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).~BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
213405|NCT01515891|P1|Participant Flow|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).~BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
213406|NCT01515891|O1|Outcome|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).~BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
213407|NCT01515891|O1|Outcome|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).~BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
213408|NCT01515891|O1|Outcome|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).~BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
213409|NCT01515891|O1|Outcome|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).~BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
213410|NCT01515891|E1|Reported Event|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).~BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
213411|NCT01515865|B1|Baseline|Enrolled Population|
213412|NCT01515865|P3|Participant Flow|Placebo - (Randomized)|On Day 16 subjects received matching placebo.
213413|NCT01515865|P2|Participant Flow|Midodrine HCl - (Randomized)|On Day 16 subjects received over-encapsulated midodrine HCl tablets (equivalent to their previously prescribed dose).
213414|NCT01515865|P1|Participant Flow|Midodrine HCl - (Open-label)|On the morning of Day -1, subjects took their usual morning dose of midodrine HCl, using their own midodrine HCl supplies at approximately the same time before rising that they would normally take their morning dose. On the morning of Day 1, subjects had their usual morning dose of midodrine HCl withheld. On Day 2, all eligible subjects continued on their midodrine HCl dose regimen over at least 14 days, using study-supplied investigational product.
213415|NCT01515865|O2|Outcome|Placebo|Matching placebo treatment (utilizing the same number of placebo capsules that would be required to constitute their midodrine HCl dose).
213416|NCT01515865|O1|Outcome|Midodrine HCl|Over-encapsulated midodrine HCl tablet at the subjects previously prescribed dose level.
213417|NCT01515865|E4|Reported Event|Placebo - Randomized (Part C)|over-encapsulated randomized matching placebo
213418|NCT01515865|E3|Reported Event|Midodrine HCl - Randomized (Part C)|over-encapsulated randomized dose (Part C) at subjects current dose level
213419|NCT01515865|E2|Reported Event|Midodrine HCl - Open-label (Part B)|open-label study-supplied (Part B) dose at subjects current dose level
213420|NCT01515865|E1|Reported Event|Midodrine HCl - Open-label (Part A)|dose at the subjects current dose level
213421|NCT01515696|B3|Baseline|Total|Total of all reporting groups
213422|NCT01515696|B2|Baseline|Sterile Water|infants receive 9ml/kg sterile water
213423|NCT01515696|B1|Baseline|Gastrografin|infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
213424|NCT01515696|P2|Participant Flow|Sterile Water|infants received 9ml/kg sterile water once during the first 24 hours of life via gastric tube
213425|NCT01515696|P1|Participant Flow|Gastrografin|infants received 3ml/kg Gastrografin + 6ml/kg sterile water once during the first 24 hours of life via gastric tube
213426|NCT01515696|O2|Outcome|Sterile Water|infants receive 9ml/kg sterile water
213427|NCT01515696|O1|Outcome|Gastrografin|infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
213428|NCT01515696|O2|Outcome|Sterile Water|infants receive 9ml/kg sterile water
213429|NCT01515696|O1|Outcome|Gastrografin|infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
213430|NCT01515696|O2|Outcome|Sterile Water|infants receive 9ml/kg sterile water
213431|NCT01515696|O1|Outcome|Gastrografin|infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
213432|NCT01515696|E2|Reported Event|Sterile Water|infants receive 9ml/kg sterile water
213433|NCT01515696|E1|Reported Event|Gastrografin|infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
213434|NCT01515657|B1|Baseline|All Study Participants|All patients that received at least 1 dose of study drug under the study protocol.
213473|NCT01515488|O2|Outcome|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)~Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
213435|NCT01515657|P3|Participant Flow|EC Aspirin First, Then PL2200 Aspirin, Then IR Aspirin Tablets|"First Intervention Period:~EC (enteric coated) aspirin: 325 mg aspirin; once per day for 3 days (after 2-week washout period)~Second Intervention Period:~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days (after 2-week washout period)~Third Intervention Period:~IR (immediate-release) aspirin tablets: 325 mg aspirin; once per day for 3 days"
213436|NCT01515657|P2|Participant Flow|IR Aspirin Tablets First, Then EC Aspirin, Then PL2200 Aspirin|"First Intervention Period:~IR (immediate-release) aspirin tablets: 325 mg aspirin; once per day for 3 days (after 2-week washout period)~Second Intervention Period:~EC (enteric coated) aspirin: 325 mg aspirin; once per day for 3 days (after 2-week washout period)~Third Intervention Period:~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days"
213437|NCT01515657|P1|Participant Flow|PL2200 Aspirin First, Then IR Aspirin Tablets, Then EC Aspirin|"First Intervention Period:~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days (after 2-week washout period)~Second Intervention Period:~IR (immediate-release) aspirin tablets: 325 mg aspirin; once per day for 3 days (after 2-week washout period)~Third Intervention Period:~EC (enteric coated) aspirin: 325 mg aspirin; once per day for 3 days"
213438|NCT01515657|O3|Outcome|Enteric-coated Aspirin Caplets|"Active comparator; crossover design~Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 3 days"
213439|NCT01515657|O2|Outcome|Immediate-Release Aspirin Tablets|"Active comparator; crossover design~Immediate-Release Aspirin Tablets: 325 mg aspirin; once per day for 3 days"
213440|NCT01515657|O1|Outcome|PL2200 Aspirin Capsules|"Investigational drug arm; crossover design~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days"
213441|NCT01515657|E3|Reported Event|Enteric-coated Aspirin Caplets|"Active comparator; crossover design~Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 3 days"
213442|NCT01515657|E2|Reported Event|Immediate-Release Aspirin Tablets|"Active comparator; crossover design~Immediate-Release Aspirin Tablets: 325 mg aspirin; once per day for 3 days"
213443|NCT01515657|E1|Reported Event|PL2200 Aspirin Capsules|"Investigational drug arm; crossover design~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days"
213444|NCT01515566|B3|Baseline|Total|Total of all reporting groups
213445|NCT01515566|B2|Baseline|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6MWT at baseline and 15 minutes after Fentanyl or Placebo. Questionnaires completed at baseline and after study visit.
213446|NCT01515566|B1|Baseline|Fentanyl|Fentanyl SQ dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test; 6 minute walk test (6MWT) at baseline and 15 minutes after Fentanyl or Placebo. Questionnaires completed at baseline and after study visit.
213447|NCT01515566|P2|Participant Flow|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6 minute walk test (6MWT) at baseline and 15 minutes after Placebo. Questionnaires completed at baseline and after study visit.
213448|NCT01515566|P1|Participant Flow|Fentanyl|Fentanyl subcutaneous (SQ) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test; 6 minute walk test (6MWT) at baseline and 15 minutes after Fentanyl. Questionnaires completed at baseline and after study visit.
213449|NCT01515566|O2|Outcome|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6MWT at baseline and 15 minutes after Placebo.
213450|NCT01515566|O1|Outcome|Fentanyl|Fentanyl SQ dose equivalent to 15-25% of MEDD 15 minutes before walk test; 6MWT at baseline and 15 minutes after Fentanyl.
213451|NCT01515566|O2|Outcome|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6MWT at baseline and 15 minutes after Placebo.
213452|NCT01515566|O1|Outcome|Fentanyl|Fentanyl SQ dose equivalent to 15-25% of MEDD 15 minutes before walk test; 6MWT at baseline and 15 minutes after Fentanyl.
213453|NCT01515566|O2|Outcome|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6MWT at baseline and 15 minutes after Placebo.
213454|NCT01515566|O1|Outcome|Fentanyl|Fentanyl SQ dose equivalent to 15-25% of MEDD 15 minutes before walk test; 6MWT at baseline and 15 minutes after Fentanyl.
213455|NCT01515566|E2|Reported Event|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test. 6 minute walk test at baseline and 15 minutes after Placebo.
213456|NCT01515566|E1|Reported Event|Fentanyl|Fentanyl SQ dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test. 6 minute walk test at baseline and 15 minutes after Fentanyl.
213457|NCT01515540|B3|Baseline|Total|Total of all reporting groups
213458|NCT01515540|B2|Baseline|Control|placebo patch
213459|NCT01515540|B1|Baseline|Lidocaine|5% lidoderm patch
213460|NCT01515540|P2|Participant Flow|Control|placebo patch
213461|NCT01515540|P1|Participant Flow|Lidocaine|5% lidoderm patch
213462|NCT01515540|O2|Outcome|Control|placebo patch
213463|NCT01515540|O1|Outcome|Lidocaine|5% lidoderm patch
213464|NCT01515540|E2|Reported Event|Control|placebo patch
213465|NCT01515540|E1|Reported Event|Lidocaine|5% lidoderm patch
213466|NCT01515488|B3|Baseline|Total|Total of all reporting groups
213467|NCT01515488|B2|Baseline|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)~Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
213468|NCT01515488|B1|Baseline|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)~Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
213469|NCT01515488|P2|Participant Flow|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)~Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
213470|NCT01515488|P1|Participant Flow|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)~Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
213471|NCT01515488|O2|Outcome|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)~Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
213472|NCT01515488|O1|Outcome|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)~Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
213474|NCT01515488|O1|Outcome|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)~Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
213475|NCT01515488|O2|Outcome|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)~Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
213476|NCT01515488|O1|Outcome|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)~Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
213477|NCT01515488|E2|Reported Event|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)~Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
213478|NCT01515488|E1|Reported Event|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)~Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
213479|NCT01515423|B3|Baseline|Total|Total of all reporting groups
213480|NCT01515423|B2|Baseline|Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
213481|NCT01515423|B1|Baseline|Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
213482|NCT01515423|P3|Participant Flow|Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
213483|NCT01515423|P2|Participant Flow|Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
213484|NCT01515423|P1|Participant Flow|Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a dose of 150 milligram equivalent (mg eq.) on Day 1 and 100 mg eq. on Day 8, both as an injection in the deltoid muscle. The injections at Week 5 (Day 36) and Week 9 (Day 64) given in either the deltoid or gluteal muscle and were flexibly dosed (50, 75, 100, or 150 mg eq.). At Week 13 (Day 92) participants received the same dose of PP1M that was administered at Week 9.
213485|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
213486|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
213487|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
213488|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
213489|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
213490|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
213491|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
213492|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
213493|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
213494|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
214163|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
213495|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
213496|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
213497|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
213498|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
213499|NCT01515423|E3|Reported Event|Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
213500|NCT01515423|E2|Reported Event|Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
213501|NCT01515423|E1|Reported Event|Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a dose of 150 milligram equivalent (mg eq.) on Day 1 and 100 mg eq. on Day 8, both as an injection in the deltoid muscle. The injections at Week 5 (Day 36) and Week 9 (Day 64) given in either the deltoid or gluteal muscle and were flexibly dosed (50, 75, 100, or 150 mg eq.). At Week 13 (Day 92) participants received the same dose of PP1M that was administered at Week 9.
213502|NCT01515410|B1|Baseline|Overall Study|DM-1992 first, then Sinemet IR; Sinemet IR first, then DM-1992
213503|NCT01515410|P2|Participant Flow|Sinemet IR First, Then DM-1992|Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD) first, then DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)
213504|NCT01515410|P1|Participant Flow|DM-1992 First, Then Sinemet IR|DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD) first, then Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)
213505|NCT01515410|O2|Outcome|Sinemet IR|Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)
213506|NCT01515410|O1|Outcome|DM-1992|DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)
213507|NCT01515410|E2|Reported Event|Sinemet IR|Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)
213508|NCT01515410|E1|Reported Event|DM-1992|DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)
213509|NCT01515345|B3|Baseline|Total|Total of all reporting groups
213510|NCT01515345|B2|Baseline|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
213511|NCT01515345|B1|Baseline|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
213512|NCT01515345|P2|Participant Flow|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
213513|NCT01515345|P1|Participant Flow|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
213514|NCT01515345|O2|Outcome|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
213515|NCT01515345|O1|Outcome|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
213516|NCT01515345|O2|Outcome|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
213517|NCT01515345|O1|Outcome|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
213518|NCT01515345|O2|Outcome|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
213519|NCT01515345|O1|Outcome|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
213520|NCT01515345|E2|Reported Event|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
213521|NCT01515345|E1|Reported Event|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
213522|NCT01515306|B3|Baseline|Total|Total of all reporting groups
213523|NCT01515306|B2|Baseline|Part B: Ramucirumab (IMC-1121B) With or Without Paclitaxel|"Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle.~Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.~*After Cycle 1 (mandatory pharmacokinetic phase) is completed, participants may continue to receive ramucirumab (IMC-1121B) monotherapy or combination therapy with paclitaxel as described in Part A."
213552|NCT01515189|O1|Outcome|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
213553|NCT01515189|O2|Outcome|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
213524|NCT01515306|B1|Baseline|Part A: Paclitaxel and Ramucirumab (IMC-1121B)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.~Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.~Cycle 3 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of each 4-week cycle."
213525|NCT01515306|P2|Participant Flow|Part B: Ramucirumab (IMC-1121B) With or Without Paclitaxel|"Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle.~Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.~*After Cycle 1 (mandatory pharmacokinetic phase) is completed, participants may continue to receive ramucirumab (IMC-1121B) monotherapy or combination therapy with paclitaxel as described in Part A."
213526|NCT01515306|P1|Participant Flow|Part A: Paclitaxel and Ramucirumab (IMC-1121B)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.~Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.~Cycle 3 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of each 4-week cycle."
213527|NCT01515306|O1|Outcome|Part A: Ramucirumab (IMC-1121B) (Cycle 2)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.~Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle."
213528|NCT01515306|O1|Outcome|Part A: Ramucirumab (IMC-1121B) (Cycle 2)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.~Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle."
213529|NCT01515306|O1|Outcome|Part B: Ramucirumab (IMC-1121B) (Cycle 1)|Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle.
213530|NCT01515306|O1|Outcome|Part A: Paclitaxel (Cycle 2)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.~Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle."
213531|NCT01515306|O1|Outcome|Part A: Paclitaxel (Cycle 1)|Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.
213532|NCT01515306|O1|Outcome|Part A: Paclitaxel (Cycle 2)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.~Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle."
213533|NCT01515306|O1|Outcome|Part A: Paclitaxel (Cycle 1)|Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.
213534|NCT01515306|E2|Reported Event|Part B: Ramucirumab (IMC-1121B) With or Without Paclitaxel|"Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle.~Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.~*After Cycle 1 (mandatory pharmacokinetic phase) is completed, participants may continue to receive ramucirumab (IMC-1121B) monotherapy or combination therapy with paclitaxel as described in Part A."
213535|NCT01515306|E1|Reported Event|Part A: Paclitaxel and Ramucirumab (IMC-1121B)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.~Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.~Cycle 3 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of each 4-week cycle."
213536|NCT01515189|B3|Baseline|Total|Total of all reporting groups
213537|NCT01515189|B2|Baseline|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
213538|NCT01515189|B1|Baseline|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
213539|NCT01515189|P2|Participant Flow|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
213540|NCT01515189|P1|Participant Flow|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
213541|NCT01515189|O2|Outcome|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
213542|NCT01515189|O1|Outcome|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
213543|NCT01515189|O2|Outcome|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
213544|NCT01515189|O1|Outcome|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
213545|NCT01515189|O2|Outcome|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
213546|NCT01515189|O1|Outcome|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
213547|NCT01515189|O2|Outcome|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
213548|NCT01515189|O1|Outcome|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
213549|NCT01515189|O2|Outcome|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
213550|NCT01515189|O1|Outcome|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
213551|NCT01515189|O2|Outcome|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
213555|NCT01515189|O2|Outcome|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
213556|NCT01515189|O1|Outcome|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
213557|NCT01515189|E2|Reported Event|3 MG/KG IPILIMUMAB|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
213558|NCT01515189|E1|Reported Event|10 MG/KG IPILIMUMAB|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
213559|NCT01515176|B3|Baseline|Total|Total of all reporting groups
213560|NCT01515176|B2|Baseline|Dose Level II:|Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 as a 2-hour infusion on cycle 2 day 8, and to 14 mg/m2 on cycle 2 day 15 and continuing thereafter
213561|NCT01515176|B1|Baseline|Dose Level I: Treatment (Ofatumumab, Dinaciclib)|Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 beginning with cycle 2 day 8 and continuing thereafter.
213562|NCT01515176|P2|Participant Flow|Dose Level II: Treatment (Ofatumumab, Dinaciclib)|Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 as a 2-hour infusion on cycle 2 day 8, and to 14 mg/m2 on cycle 2 day 15 and continuing thereafter
213563|NCT01515176|P1|Participant Flow|Dose Level I: Treatment (Ofatumumab, Dinaciclib)|Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 beginning with cycle 2 day 8 and continuing thereafter.
213564|NCT01515176|O1|Outcome|Treatment (Ofatumumab, Dinaciclib)|"Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib IV over 2 hours on days 2, 8, and 15 of course 2, and on days 1, 8, and 15 of courses 3-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity.~Dinaciclib: Given IV~Laboratory Biomarker Analysis: Correlative studies~Ofatumumab: Given IV~Pharmacological Study: Correlative studies"
213565|NCT01515176|O1|Outcome|Dose Level I and Dose Level II|"Dose Level I:~Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7.~Dose Level II:~Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib IV over 2 hours on days 2, 8, and 15 of course 2, and on days 1, 8, and 15 of courses 3-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity."
213566|NCT01515176|O1|Outcome|Treatment (Ofatumumab, Dinaciclib)|"Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib IV over 2 hours on days 2, 8, and 15 of course 2, and on days 1, 8, and 15 of courses 3-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity.~Dinaciclib: Given IV~Laboratory Biomarker Analysis: Correlative studies~Ofatumumab: Given IV~Pharmacological Study: Correlative studies"
213567|NCT01515176|O1|Outcome|Treatment (Ofatumumab, Dinaciclib)|"Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib IV over 2 hours on days 2, 8, and 15 of course 2, and on days 1, 8, and 15 of courses 3-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity.~Dinaciclib: Given IV~Laboratory Biomarker Analysis: Correlative studies~Ofatumumab: Given IV~Pharmacological Study: Correlative studies"
213568|NCT01515176|O1|Outcome|Dose Level I and Dose Level II|"Dose Level I:~Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7.~Dose Level II:~Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib IV over 2 hours on days 2, 8, and 15 of course 2, and on days 1, 8, and 15 of courses 3-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity."
213569|NCT01515176|O2|Outcome|Dose Level II: Treatment (Ofatumumab, Dinaciclib)|Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 as a 2-hour infusion on cycle 2 day 8, and to 14 mg/m2 on cycle 2 day 15 and continuing thereafter
213570|NCT01515176|O1|Outcome|Dose Level I: Treatment (Ofatumumab, Dinaciclib)|Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 beginning with cycle 2 day 8 and continuing thereafter.
213571|NCT01515176|O1|Outcome|Treatment (Ofatumumab, Dinaciclib)|"Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib IV over 2 hours on days 2, 8, and 15 of course 2, and on days 1, 8, and 15 of courses 3-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity.~Dinaciclib: Given IV~Laboratory Biomarker Analysis: Correlative studies~Ofatumumab: Given IV~Pharmacological Study: Correlative studies"
213572|NCT01515176|E2|Reported Event|Dose Level II: Treatment (Ofatumumab, Dinaciclib)|Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 as a 2-hour infusion on cycle 2 day 8, and to 14 mg/m2 on cycle 2 day 15 and continuing thereafter
213573|NCT01515176|E1|Reported Event|Dose Level I: Treatment (Ofatumumab, Dinaciclib)|Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 beginning with cycle 2 day 8 and continuing thereafter.
213574|NCT01515072|B3|Baseline|Total|Total of all reporting groups
213575|NCT01515072|B2|Baseline|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.~RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
213576|NCT01515072|B1|Baseline|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
213577|NCT01515072|P2|Participant Flow|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.~RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
213578|NCT01515072|P1|Participant Flow|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
213579|NCT01515072|O2|Outcome|RIPC|The recipients in this group received one or more organs from donors in the RIPC arm of the RIPNOD trial
213580|NCT01515072|O1|Outcome|No RIPC|The recipients in this group received one or more organs from donors in the No RIPC arm of the RIPNOD trial.
213581|NCT01515072|O2|Outcome|RIPC|Kidneys in this group were recovered from donors in the RIPC arm.
213582|NCT01515072|O1|Outcome|No RIPC|Kidneys in this group were recovered from donors in the No RIPC arm.
213583|NCT01515072|O2|Outcome|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.~RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
213584|NCT01515072|O1|Outcome|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
213585|NCT01515072|O2|Outcome|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.~RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
213586|NCT01515072|O1|Outcome|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
213587|NCT01515072|O2|Outcome|Remote Ischemic Preconditioning|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.~RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
213588|NCT01515072|O1|Outcome|No Remote Ischemic Preconditioning|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
213589|NCT01515072|O2|Outcome|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.~RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
213590|NCT01515072|O1|Outcome|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
213766|NCT01514357|B1|Baseline|Nesiritide (BNP)|Subjects will receive subcutaneous (SQ) BNP bid for seven consecutive days. The initial starting dose was 5 micrograms/kg.
213591|NCT01515072|O2|Outcome|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.~RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
213592|NCT01515072|O1|Outcome|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
213593|NCT01515072|O2|Outcome|RIPC|"Kidneys in this group were recovered from donors in the RIPC arm. Decisions regarding which kidneys were not and were pumped were made by the OPO.~Any discrepancy in the number of participants is attributed to missing data for some subjects."
213594|NCT01515072|O1|Outcome|No RIPC|"Kidneys in this group were recovered from donors in the No RIPC arm. Decisions regarding which kidneys were not and were pumped were made by the OPO.~Any discrepancy in the number of participants is attributed to missing data for some subjects."
213595|NCT01515072|O2|Outcome|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.~RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
213596|NCT01515072|O1|Outcome|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
213597|NCT01515072|O2|Outcome|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first occurs immediately after brain death declaration and consent for organ donation. The second one immediately before of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.~RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention occurs at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb.~Any discrepancy in the number of participants is attributed to missing data for some participants"
213598|NCT01515072|O1|Outcome|No RIPC|"The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.~Any discrepancy in the number of participants is attributed to missing data for some participants"
213599|NCT01515072|O2|Outcome|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first occurs immediately after brain death declaration and consent for organ donation. The second one immediately before of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.~RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention occurs at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb.~Any discrepancy in the number of participants is attributed to missing data for some participants"
213600|NCT01515072|O1|Outcome|No RIPC|"The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.~Any discrepancy in the number of participants is attributed to missing data for some participants"
213601|NCT01515072|O2|Outcome|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.~RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
213602|NCT01515072|O1|Outcome|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
213603|NCT01515072|O2|Outcome|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.~RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
213767|NCT01514357|P2|Participant Flow|Placebo|Subjects will receive SQ placebo bid for seven consecutive days.
213604|NCT01515072|O1|Outcome|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
213605|NCT01515072|O2|Outcome|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.~RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
213606|NCT01515072|O1|Outcome|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
213607|NCT01515072|O2|Outcome|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.~RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
213608|NCT01515072|O1|Outcome|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
213609|NCT01515072|O2|Outcome|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.~RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
213610|NCT01515072|O1|Outcome|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
213611|NCT01515072|E6|Reported Event|RIPC, Donors|Donors in this group received two RIPC interventions
213612|NCT01515072|E5|Reported Event|No RIPC, Donors|Donors in this group did not receive remote ischemic preconditioning (RIPC)
213613|NCT01515072|E4|Reported Event|RIPC, All Organ Recipients|Recipients in this group received organs from donors who received two RIPC interventions
213614|NCT01515072|E3|Reported Event|No RIPC, All Organ Recipients|Recipients in this group received organs from donors who did not receive remote ischemic preconditioning (No RIPC)
213615|NCT01515072|E2|Reported Event|RIPC, Kidney Recipients|Recipients in this group received kidneys from donors who received two RIPC interventions
213616|NCT01515072|E1|Reported Event|No RIPC, Kidney Recipients|Recipients in this group received kidneys from donors who did not receive remote ischemic preconditioning (No RIPC group)
213617|NCT01515046|B1|Baseline|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.~Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.~Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)~Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
213618|NCT01515046|P1|Participant Flow|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.~Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.~Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)~Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
213619|NCT01515046|O1|Outcome|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.~Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.~Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)~Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
213620|NCT01515046|O1|Outcome|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.~Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.~Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)~Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
213621|NCT01515046|O1|Outcome|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.~Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.~Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)~Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
213622|NCT01515046|O1|Outcome|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.~Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.~Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)~Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
213623|NCT01515046|O1|Outcome|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.~Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.~Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)~Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
213624|NCT01515046|E1|Reported Event|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.~Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.~Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)~Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
213625|NCT01514864|B3|Baseline|Total|Total of all reporting groups
213626|NCT01514864|B2|Baseline|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
213627|NCT01514864|B1|Baseline|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
213628|NCT01514864|P2|Participant Flow|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
213629|NCT01514864|P1|Participant Flow|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
213630|NCT01514864|O1|Outcome|Dasatinib, 140 mg|Participants with nonsmall-cell lung cancer (NSCLC) received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred. Data from both arms were combined for safety reporting, because the safety profile of dasatinib should not have be affected by the type of mutation in the tumor. In addition, pooling the data from both arms increased the robustness of the data set.
213631|NCT01514864|O2|Outcome|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
213632|NCT01514864|O1|Outcome|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
213633|NCT01514864|O2|Outcome|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
213634|NCT01514864|O1|Outcome|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
213635|NCT01514864|O2|Outcome|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
213636|NCT01514864|O1|Outcome|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
213637|NCT01514864|O2|Outcome|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
213638|NCT01514864|O1|Outcome|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
213639|NCT01514864|O2|Outcome|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
213640|NCT01514864|O1|Outcome|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
213641|NCT01514864|O2|Outcome|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
213642|NCT01514864|O1|Outcome|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
213643|NCT01514864|E1|Reported Event|Dasatinib, 140 mg|Participants with nonsmall-cell lung cancer received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred. Data from both arms were combined for safety reporting, because the safety profile of dasatinib should not have be affected by the type of mutation in the tumor. In addition, pooling the data from both arms increased the robustness of the data set.
213644|NCT01514786|B3|Baseline|Total|Total of all reporting groups
213645|NCT01514786|B2|Baseline|Intervention With Colorectal Website|"Intervention website includes an interactive component including preferences and risk assessment.~Colorectal Web: The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS"
213646|NCT01514786|B1|Baseline|Control|Same information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment.
213647|NCT01514786|P2|Participant Flow|Intervention With Colorectal Website|"Intervention website includes an interactive component including preferences and risk assessment.~Colorectal Web: The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS"
213648|NCT01514786|P1|Participant Flow|Control|Same information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment.
213649|NCT01514786|O2|Outcome|Intervention With Colorectal Website|"Intervention website includes an interactive component including preferences and risk assessment.~Colorectal Web: The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS"
213650|NCT01514786|O1|Outcome|Control|Same information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment.
213651|NCT01514786|E2|Reported Event|Intervention With Colorectal Website|"Intervention website includes an interactive component including preferences and risk assessment.~Colorectal Web: The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS"
213652|NCT01514786|E1|Reported Event|Control|Same information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment.
213653|NCT01514760|B1|Baseline|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.~Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
213654|NCT01514760|P1|Participant Flow|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.~Mobile-based Asthma Action Plan : The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
213655|NCT01514760|O1|Outcome|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.~Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
213656|NCT01514760|O1|Outcome|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.~Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
213672|NCT01514682|O1|Outcome|Placebo|"Placebo pills to be assigned using a permuted randomization system~Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose~Placebo: Non-medication pills; To be taken in morning and evening intervals."
214164|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
213657|NCT01514760|O1|Outcome|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.~Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
213658|NCT01514760|O1|Outcome|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.~Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
213659|NCT01514760|E1|Reported Event|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.~Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
213660|NCT01514734|B1|Baseline|AZARGA|Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
213661|NCT01514734|P1|Participant Flow|AZARGA|Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
213662|NCT01514734|O1|Outcome|AZARGA|Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
213663|NCT01514734|E1|Reported Event|AZARGA|Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
213664|NCT01514682|B3|Baseline|Total|Total of all reporting groups
213665|NCT01514682|B2|Baseline|Placebo|"Placebo pills to be assigned using a permuted randomization system~Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose~Placebo: Non-medication pills; To be taken in morning and evening intervals."
213666|NCT01514682|B1|Baseline|Anti-inflammatory Combination Therapy|"Salsalate, statin and omega-3-fatty acid combination therapy~Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose"
213667|NCT01514682|P2|Participant Flow|Placebo|"Placebo pills to be assigned using a permuted randomization system~Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose~Placebo: Non-medication pills; To be taken in morning and evening intervals."
213668|NCT01514682|P1|Participant Flow|Anti-inflammatory Combination Therapy|"Salsalate, statin and omega-3-fatty acid combination therapy~Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose"
213669|NCT01514682|O2|Outcome|Anti-inflammatory Combination Therapy|"Salsalate, statin and omega-3-fatty acid combination therapy~Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose"
213670|NCT01514682|O1|Outcome|Placebo|"Placebo pills to be assigned using a permuted randomization system~Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose~Placebo: Non-medication pills; To be taken in morning and evening intervals."
213671|NCT01514682|O2|Outcome|Anti-inflammatory Combination Therapy|"Salsalate, statin and omega-3-fatty acid combination therapy~Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose"
213690|NCT01514513|P2|Participant Flow|Nix Creme Rinse, 1% Permethrin|1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
214165|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
213673|NCT01514682|O2|Outcome|Anti-inflammatory Combination Therapy|"Salsalate, statin and omega-3-fatty acid combination therapy~Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose"
213674|NCT01514682|O1|Outcome|Placebo|"Placebo pills to be assigned using a permuted randomization system~Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose~Placebo: Non-medication pills; To be taken in morning and evening intervals."
213675|NCT01514682|O2|Outcome|Anti-inflammatory Combination Therapy|"Salsalate, statin and omega-3-fatty acid combination therapy~Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose"
213676|NCT01514682|O1|Outcome|Placebo|"Placebo pills to be assigned using a permuted randomization system~Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose~Placebo: Non-medication pills; To be taken in morning and evening intervals."
213677|NCT01514682|O2|Outcome|Anti-inflammatory Combination Therapy|"Salsalate, statin and omega-3-fatty acid combination therapy~Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose"
213678|NCT01514682|O1|Outcome|Placebo|"Placebo pills to be assigned using a permuted randomization system~Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose~Placebo: Non-medication pills; To be taken in morning and evening intervals."
213679|NCT01514682|O2|Outcome|Anti-inflammatory Combination Therapy|"Salsalate, statin and omega-3-fatty acid combination therapy~Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose"
213680|NCT01514682|O1|Outcome|Placebo|"Placebo pills to be assigned using a permuted randomization system~Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose~Placebo: Non-medication pills; To be taken in morning and evening intervals."
213681|NCT01514682|E2|Reported Event|Anti-inflammatory Combination Therapy|"Salsalate, statin and omega-3-fatty acid combination therapy~Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose"
213682|NCT01514682|E1|Reported Event|Placebo|"Placebo pills to be assigned using a permuted randomization system~Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose~Placebo: Non-medication pills; To be taken in morning and evening intervals."
213683|NCT01514630|B1|Baseline|Creatine Monohydrate|"14 female depressed methamphetamine users will receive 5 grams of creatine monohydrate daily for eight weeks.~Creatine monohydrate: Five grams of creatine monohydrate will be administered for eight weeks."
213684|NCT01514630|P1|Participant Flow|Creatine Monohydrate|14 female depressed methamphetamine users received 5 grams of creatine monohydrate daily for eight weeks. Participants were seen twice weekly after creatine was initiated. All participants met SCID-I/P criteria for lifetime methamphetamine dependence or for current methamphetamine dependence. After consent was obtained, the principal investigator administered the SCID-I/P and HAMD, and if a female met SCID-I/P criteria and scored > 15 on the HAMD, the following additional screening data were collected: Beck Anxiety Inventory, C-SSRS , vital signs, concomitant medications, self-report drug use over the past 48 hours for cigarettes, alcohol, cocaine, methamphetamine, marijuana, heroin and prescription controlled substances, urine drug screen for methamphetamine, opiates, benzodiazepines, marijuana and cocaine, pregnancy testing and attendance in outpatient treatment and/or 12 step programs.
213685|NCT01514630|O1|Outcome|Creatine Monohydrate|"14 female depressed methamphetamine users will receive 5 grams of creatine monohydrate daily for eight weeks.~Creatine monohydrate: Five grams of creatine monohydrate will be administered for eight weeks."
213686|NCT01514630|E1|Reported Event|Creatine Monohydrate|"14 female depressed methamphetamine users will receive 5 grams of creatine monohydrate daily for eight weeks.~Creatine monohydrate: Five grams of creatine monohydrate will be administered for eight weeks."
213687|NCT01514513|B3|Baseline|Total|Total of all reporting groups
213688|NCT01514513|B2|Baseline|Nix Creme Rinse, 1% Permethrin|1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
213689|NCT01514513|B1|Baseline|Licefreee Spray|Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
215036|NCT01510158|O1|Outcome|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
213691|NCT01514513|P1|Participant Flow|Licefreee Spray|Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
213692|NCT01514513|O2|Outcome|Nix Creme Rinse, 1% Permethrin|1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
213693|NCT01514513|O1|Outcome|Licefreee Spray|Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
213694|NCT01514513|O2|Outcome|Nix Creme Rinse, 1% Permethrin|1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
213695|NCT01514513|O1|Outcome|Licefreee Spray|Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
213696|NCT01514513|E2|Reported Event|Nix Creme Rinse, 1% Permethrin|1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
213697|NCT01514513|E1|Reported Event|Licefreee Spray|Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
213698|NCT01514461|B4|Baseline|Total|Total of all reporting groups
213699|NCT01514461|B3|Baseline|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213700|NCT01514461|B2|Baseline|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213701|NCT01514461|B1|Baseline|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213702|NCT01514461|P3|Participant Flow|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213703|NCT01514461|P2|Participant Flow|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213704|NCT01514461|P1|Participant Flow|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213705|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213706|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213707|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213708|NCT01514461|O2|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213756|NCT01514448|E2|Reported Event|1st Line PAZ|Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
213768|NCT01514357|P1|Participant Flow|Nesiritide (BNP)|Subjects will receive subcutaneous (SQ) BNP bid for seven consecutive days. The initial starting dose was 5 micrograms/kg.
213709|NCT01514461|O1|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213710|NCT01514461|O2|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213711|NCT01514461|O1|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213712|NCT01514461|O2|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213713|NCT01514461|O1|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213714|NCT01514461|O2|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213715|NCT01514461|O1|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213716|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213717|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213718|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213719|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213720|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213721|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213757|NCT01514448|E1|Reported Event|1st Line SUN|Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
213758|NCT01514422|B1|Baseline|Minocycline|Minocycline 100 to 300mg per day for 8 weeks
213722|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213723|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213724|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213725|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213726|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213727|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213728|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213729|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213730|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213731|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213732|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213733|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213734|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213759|NCT01514422|P1|Participant Flow|Minocycline|Minocycline 100 to 300mg per day for 8 weeks
213760|NCT01514422|O1|Outcome|Minocycline|Minocycline for 8 weeks
213761|NCT01514422|O1|Outcome|Minocycline|Minocycline for 8 weeks
213762|NCT01514422|O1|Outcome|Minocycline|Minocycline for 8 weeks
213763|NCT01514422|E1|Reported Event|Minocycline|Minocycline for 8 weeks
213735|NCT01514461|O2|Outcome|LCQ908 20mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213736|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213737|NCT01514461|E3|Reported Event|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213738|NCT01514461|E2|Reported Event|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen will follow. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet will be followed and recorded in patient diary.
213739|NCT01514461|E1|Reported Event|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
213740|NCT01514448|B3|Baseline|Total|Total of all reporting groups
213741|NCT01514448|B2|Baseline|1st Line PAZ|Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
213742|NCT01514448|B1|Baseline|1st Line SUN|Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
213743|NCT01514448|P2|Participant Flow|1st Line PAZ|Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
213744|NCT01514448|P1|Participant Flow|1st Line SUN|Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
213745|NCT01514448|O2|Outcome|1st Line PAZ|Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
213746|NCT01514448|O1|Outcome|1st Line SUN|Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
213747|NCT01514448|O2|Outcome|1st Line PAZ|Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
213748|NCT01514448|O1|Outcome|1st Line SUN|Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
213749|NCT01514448|O2|Outcome|1st Line PAZ|Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
213750|NCT01514448|O1|Outcome|1st Line SUN|Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
213751|NCT01514448|O2|Outcome|1st Line PAZ|Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
213752|NCT01514448|O1|Outcome|1st Line SUN|Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
213753|NCT01514448|O2|Outcome|1st Line PAZ|Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
213754|NCT01514448|O1|Outcome|1st Line SUN|Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
213755|NCT01514448|E3|Reported Event|Everolimus All Patients|Everolimus - All Patients that failed 1st line SUN and 1st Line PAZ and was on Everolimus 10mg orally once daily
213764|NCT01514357|B3|Baseline|Total|Total of all reporting groups
213765|NCT01514357|B2|Baseline|Placebo|Subjects will receive SQ placebo bid for seven consecutive days.
213770|NCT01514357|O1|Outcome|Nesiritide (BNP)|Subjects will receive subcutaneous (SQ) Nesiritide (BNP) bid for seven consecutive days. The initial starting dose was 5 micrograms/kg.
213771|NCT01514357|E2|Reported Event|Placebo|Subjects will receive SQ placebo bid for seven consecutive days.
213772|NCT01514357|E1|Reported Event|Nesiritide (BNP)|Subjects will receive subcutaneous (SQ) BNP bid for seven consecutive days. The initial starting dose was 5 micrograms/kg.
213773|NCT01514318|B1|Baseline|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
213774|NCT01514318|P1|Participant Flow|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
213775|NCT01514318|O1|Outcome|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
213776|NCT01514318|O1|Outcome|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
213777|NCT01514318|O1|Outcome|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
213778|NCT01514318|E1|Reported Event|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
213779|NCT01514292|B1|Baseline|Real Time Continuous Glucose Monitoring System|Real Time Continuous Glucose Monitoring(CGM) System Wearing for up to 7 days.
213780|NCT01514292|P1|Participant Flow|CGM Device|Dexcom CGM Device Wearing for up to 7 days
213781|NCT01514292|O1|Outcome|Real Time Continous Glucose Monitoring System|Real Time Continous Glucose Monitoring System Wearing for up to 7 days
213782|NCT01514292|E1|Reported Event|CGM Device|Dexcom CGM Device Wearing for up to 7 days
213783|NCT01514240|B3|Baseline|Total|Total of all reporting groups
213784|NCT01514240|B2|Baseline|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213785|NCT01514240|B1|Baseline|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213786|NCT01514240|P2|Participant Flow|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213787|NCT01514240|P1|Participant Flow|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213788|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213789|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213790|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213791|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213792|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213793|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213794|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213795|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213796|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213797|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213798|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213799|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213800|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213801|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213802|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
214166|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
213803|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213804|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213805|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213806|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213807|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213808|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213809|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213810|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213811|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213812|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213813|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213814|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213815|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213816|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213817|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213818|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213819|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213820|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213821|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213822|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213823|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213824|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213825|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213826|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213827|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213828|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213829|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213982|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
213830|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213831|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213832|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213833|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213834|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213835|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213836|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213837|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213838|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213839|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213840|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213841|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213842|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213843|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213844|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213845|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213846|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213847|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213848|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213849|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213850|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213851|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213852|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213853|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213854|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213855|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213856|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213983|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
213857|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213858|NCT01514240|E2|Reported Event|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
213859|NCT01514240|E1|Reported Event|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
213860|NCT01514162|B1|Baseline|Trifecta Valve Group|Subjects implanted with a Trifecta valve.
213861|NCT01514162|P1|Participant Flow|Trifecta Valve Group|Subjects implanted with a Trifecta valve.
213862|NCT01514162|O1|Outcome|Trifecta Valve Group|Subjects implanted with a Trifecta valve.
213863|NCT01514162|O1|Outcome|Trifecta Valve Group|Subjects implanted with a Trifecta valve.
213864|NCT01514162|O1|Outcome|Trifecta Valve Group|Subjects implanted with a Trifecta valve.
213865|NCT01514162|E1|Reported Event|Trifecta Valve Group|Subjects implanted with a Trifecta valve.
213866|NCT01514149|B6|Baseline|Total|Total of all reporting groups
213867|NCT01514149|B5|Baseline|Arm 5 - Weekly Placebo|Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
213868|NCT01514149|B4|Baseline|Arm 4 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection
213869|NCT01514149|B3|Baseline|Arm 3 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection
213870|NCT01514149|B2|Baseline|Arm 2 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection
213871|NCT01514149|B1|Baseline|Arm 1 - Weekly CJC-1134-PC|CJC-1134-PC, 1.5 mg. weekly subcutaneous injection
213872|NCT01514149|P5|Participant Flow|Arm 5 - Weekly Placebo|Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
213873|NCT01514149|P4|Participant Flow|Arm 4 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection
213874|NCT01514149|P3|Participant Flow|Arm 3 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection
213875|NCT01514149|P2|Participant Flow|Arm 2 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection
213876|NCT01514149|P1|Participant Flow|Arm 1 - Weekly CJC-1134-PC|CJC-1134-PC, 1.5 mg. weekly subcutaneous injection
213877|NCT01514149|O5|Outcome|Arm 5 - Weekly Placebo|Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
213878|NCT01514149|O4|Outcome|Arm 4 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection
213879|NCT01514149|O3|Outcome|Arm 3 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection
213880|NCT01514149|O2|Outcome|Arm 2 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection
213881|NCT01514149|O1|Outcome|Arm 1 - Weekly CJC-1134-PC|CJC-1134-PC, 1.5 mg. weekly subcutaneous injection
213882|NCT01514149|O5|Outcome|Arm 5 - Weekly Placebo|Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
213883|NCT01514149|O4|Outcome|Arm 4 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection
213884|NCT01514149|O3|Outcome|Arm 3 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection
213885|NCT01514149|O2|Outcome|Arm 2 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection
213886|NCT01514149|O1|Outcome|Arm 1 - Weekly CJC-1134-PC|CJC-1134-PC, 1.5 mg. weekly subcutaneous injection
213887|NCT01514149|O5|Outcome|Arm 5 - Weekly Placebo|Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
213888|NCT01514149|O4|Outcome|Arm 4 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection
213889|NCT01514149|O3|Outcome|Arm 3 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection
213890|NCT01514149|O2|Outcome|Arm 2 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection
213891|NCT01514149|O1|Outcome|Arm 1 - Weekly CJC-1134-PC|CJC-1134-PC, 1.5 mg. weekly subcutaneous injection
213892|NCT01514149|E5|Reported Event|Arm 5 - Weekly Placebo|Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
213893|NCT01514149|E4|Reported Event|Arm 4 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection
213894|NCT01514149|E3|Reported Event|Arm 3 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection
213895|NCT01514149|E2|Reported Event|Arm 2 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection
213896|NCT01514149|E1|Reported Event|Arm 1 - Weekly CJC-1134-PC|CJC-1134-PC, 1.5 mg. weekly subcutaneous injection
213897|NCT01514136|B3|Baseline|Total|Total of all reporting groups
213898|NCT01514136|B2|Baseline|Flat Product Users|Subjects who usually use a flat product
213899|NCT01514136|B1|Baseline|Convex Product Users|Subjects who usually use a convex product
213900|NCT01514136|P8|Participant Flow|Test D*|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test D* was a newly developed optimized concept by Coloplast A/S for the second round."
213984|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
213901|NCT01514136|P7|Participant Flow|Test C*|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test C* was a newly developed optimized concept by Coloplast A/S for the second round."
213902|NCT01514136|P6|Participant Flow|Test B*|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test B* was a newly developed optimized concept by Coloplast A/S for the second round."
213903|NCT01514136|P5|Participant Flow|Test A*|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test A* was a newly developed optimized concept by Coloplast A/S for the second round."
213904|NCT01514136|P4|Participant Flow|Test D|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test D was a newly developed concept by Coloplast A/S for the first round."
213905|NCT01514136|P3|Participant Flow|Test C|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test C was a newly developed concept by Coloplast A/S for the first round."
213906|NCT01514136|P2|Participant Flow|Test B|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test B was a newly developed concept by Coloplast A/S for the first round."
213907|NCT01514136|P1|Participant Flow|Test A|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test A was a newly developed concept by Coloplast A/S for the first round."
213908|NCT01514136|O16|Outcome|Test D* - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test D* was a newly developed optimized concept by Coloplast A/S for the second round."
213909|NCT01514136|O15|Outcome|Test C* - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test C* was a newly developed optimized concept by Coloplast A/S for the second round."
213910|NCT01514136|O14|Outcome|Test B* - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test B* was a newly developed optimized concept by Coloplast A/S for the second round."
213911|NCT01514136|O13|Outcome|Test A* - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test A* was a newly developed optimized concept by Coloplast A/S for the second round."
213912|NCT01514136|O12|Outcome|Test D - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test D was a newly developed concept by Coloplast A/S for the first round."
213913|NCT01514136|O11|Outcome|Test C - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test C was a newly developed concept by Coloplast A/S for the first round."
213914|NCT01514136|O10|Outcome|Test B - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test B was a newly developed concept by Coloplast A/S for the first round."
213915|NCT01514136|O9|Outcome|Test A - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test A was a newly developed concept by Coloplast A/S for the first round."
213916|NCT01514136|O8|Outcome|Test D* - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test D* was a newly developed optimized concept by Coloplast A/S for the second round."
214167|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
213917|NCT01514136|O7|Outcome|Test C* - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test C* was a newly developed optimized concept by Coloplast A/S for the second round."
213918|NCT01514136|O6|Outcome|Test B* - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test B* was a newly developed optimized concept by Coloplast A/S for the second round."
213919|NCT01514136|O5|Outcome|Test A* - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test A* was a newly developed optimized concept by Coloplast A/S for the second round."
213920|NCT01514136|O4|Outcome|Test D - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test D was a newly developed concept by Coloplast A/S for the first round."
213921|NCT01514136|O3|Outcome|Test C - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test C was a newly developed concept by Coloplast A/S for the first round."
213922|NCT01514136|O2|Outcome|Test B - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test B was a newly developed concept by Coloplast A/S for the first round."
213923|NCT01514136|O1|Outcome|Test A - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test A was a newly developed concept by Coloplast A/S for the first round."
213924|NCT01514136|E8|Reported Event|Test D*|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test D* was a newly developed optimized concept by Coloplast A/S for the second round."
213925|NCT01514136|E7|Reported Event|Test C*|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test C* was a newly developed optimized concept by Coloplast A/S for the second round."
213926|NCT01514136|E6|Reported Event|Test B*|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test B* was a newly developed optimized concept by Coloplast A/S for the second round."
213927|NCT01514136|E5|Reported Event|Test A*|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test A* was a newly developed optimized concept by Coloplast A/S for the second round."
213928|NCT01514136|E4|Reported Event|Test D|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test D was a newly developed concept by Coloplast A/S for the first round."
213929|NCT01514136|E3|Reported Event|Test C|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test C was a newly developed concept by Coloplast A/S for the first round."
213930|NCT01514136|E2|Reported Event|Test B|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test B was a newly developed concept by Coloplast A/S for the first round."
213931|NCT01514136|E1|Reported Event|Test A|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test A was a newly developed concept by Coloplast A/S for the first round."
213932|NCT01513902|B4|Baseline|Total|Total of all reporting groups
213933|NCT01513902|B3|Baseline|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
213934|NCT01513902|B2|Baseline|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
213935|NCT01513902|B1|Baseline|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
213985|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
213936|NCT01513902|P3|Participant Flow|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
213937|NCT01513902|P2|Participant Flow|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
213938|NCT01513902|P1|Participant Flow|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
213939|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
213940|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
213941|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
213942|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
213943|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
213944|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
213945|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
213946|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
213947|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
213948|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
213949|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
213950|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
213951|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
213952|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
213953|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
213954|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
213955|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
213956|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
213957|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
213958|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
213959|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
213960|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
213961|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
213962|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
213963|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
213964|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
213965|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
213966|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
213967|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
213968|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
213969|NCT01513902|E3|Reported Event|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
213970|NCT01513902|E2|Reported Event|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
213971|NCT01513902|E1|Reported Event|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
213972|NCT01513590|B3|Baseline|Total|Total of all reporting groups
213973|NCT01513590|B2|Baseline|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
213974|NCT01513590|B1|Baseline|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
213975|NCT01513590|P2|Participant Flow|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
213976|NCT01513590|P1|Participant Flow|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
213977|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
213978|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
213979|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
213980|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
213981|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
213986|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
213987|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
213988|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
213989|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
213990|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
213991|NCT01513590|E2|Reported Event|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
213992|NCT01513590|E1|Reported Event|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
213993|NCT01513538|B1|Baseline|TherapyGuide|"Patients implanted with a dual chamber pacemaker featuring the TherapyGuide function~TherapyGuide: Use of TherapyGuide function to help programming the device"
213994|NCT01513538|P1|Participant Flow|Patients Implanted With a Dual Chamber Pacemaker|All the enrolled patients were patients implanted with a dual chamber pacemaker with the Therapy Guide application : one-arm study.
213995|NCT01513538|O1|Outcome|Patients Implanted With a Dual Chamber Pacemaker|All the patients were implanted with a dual chamber pacemaker with Therapy Guide function : one-arm study.
213996|NCT01513538|E1|Reported Event|Patients Implanted With a Dual Chamber Pacemaker|All the patients were implanted with a dual chamber pacemaker with Therapy Guide function : one-arm study.
213997|NCT01513473|B3|Baseline|Total|Total of all reporting groups
213998|NCT01513473|B2|Baseline|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
213999|NCT01513473|B1|Baseline|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
214000|NCT01513473|P2|Participant Flow|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
214001|NCT01513473|P1|Participant Flow|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
214002|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
214003|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
214004|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
214005|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
214006|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
214007|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
214168|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
214169|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
214008|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
214009|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
214010|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
214011|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
214012|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
214013|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
214014|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
214015|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
214016|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
214017|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
214018|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
214019|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
214020|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
214021|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
214022|NCT01513473|E2|Reported Event|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
214065|NCT01513330|P2|Participant Flow|First Standard Care, Then SenSura Mio|The subjects first test Standard Care Ostomy product 1 piece closed bags (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima)and after cross-over test SenSura Mio 1-piece closed bags.
214023|NCT01513473|E1|Reported Event|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
214024|NCT01513460|B4|Baseline|Total|Total of all reporting groups
214025|NCT01513460|B3|Baseline|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214026|NCT01513460|B2|Baseline|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214027|NCT01513460|B1|Baseline|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214028|NCT01513460|P3|Participant Flow|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214029|NCT01513460|P2|Participant Flow|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214030|NCT01513460|P1|Participant Flow|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214031|NCT01513460|O3|Outcome|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214032|NCT01513460|O2|Outcome|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214033|NCT01513460|O1|Outcome|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214034|NCT01513460|O3|Outcome|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214035|NCT01513460|O2|Outcome|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214036|NCT01513460|O1|Outcome|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214037|NCT01513460|O3|Outcome|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214108|NCT01513291|O1|Outcome|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
214038|NCT01513460|O2|Outcome|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214039|NCT01513460|O1|Outcome|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214040|NCT01513460|O3|Outcome|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214041|NCT01513460|O2|Outcome|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214042|NCT01513460|O1|Outcome|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214043|NCT01513460|O3|Outcome|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214044|NCT01513460|O2|Outcome|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214045|NCT01513460|O1|Outcome|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214046|NCT01513460|O2|Outcome|NVA237/Tiotropium+Flu/Sal|NVA237+Flu/Sal and Tiotropium+Flu/Sal arms
214047|NCT01513460|O1|Outcome|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214048|NCT01513460|O2|Outcome|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214049|NCT01513460|O1|Outcome|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214050|NCT01513460|E3|Reported Event|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214051|NCT01513460|E2|Reported Event|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214052|NCT01513460|E1|Reported Event|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
214053|NCT01513447|B3|Baseline|Total|Total of all reporting groups
214054|NCT01513447|B2|Baseline|Normal Saline Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
214055|NCT01513447|B1|Baseline|Sterile Water Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
214056|NCT01513447|P2|Participant Flow|Normal Saline Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
214057|NCT01513447|P1|Participant Flow|Sterile Water Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
214058|NCT01513447|O2|Outcome|Normal Saline Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
214059|NCT01513447|O1|Outcome|Sterile Water Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
214060|NCT01513447|O2|Outcome|Normal Saline Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
214061|NCT01513447|O1|Outcome|Sterile Water Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
214062|NCT01513447|E2|Reported Event|Normal Saline Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
214063|NCT01513447|E1|Reported Event|Sterile Water Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
214064|NCT01513330|B1|Baseline|Entire Study Population|Entire study population = all participants enrolled in the study
214066|NCT01513330|P1|Participant Flow|First SenSura Mio, Then Standard Care|The subjects first test SenSura Mio : Ostomy product - 1 piece closed bag and thereafter cross-over and test Standard Care (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima)
214067|NCT01513330|O2|Outcome|Standard Care|Standard Care : Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.
214068|NCT01513330|O1|Outcome|SenSura Mio|SenSura Mio : Ostomy product - 1 piece closed bag
214069|NCT01513330|E2|Reported Event|Standard Care|Standard Care : Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.
214070|NCT01513330|E1|Reported Event|SenSura Mio|SenSura Mio : Ostomy product - 1 piece closed bag
214071|NCT01513317|B3|Baseline|Total|Total of all reporting groups
214072|NCT01513317|B2|Baseline|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
214073|NCT01513317|B1|Baseline|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
214074|NCT01513317|P2|Participant Flow|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
214075|NCT01513317|P1|Participant Flow|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
214076|NCT01513317|O2|Outcome|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
214077|NCT01513317|O1|Outcome|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
214078|NCT01513317|O2|Outcome|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
214079|NCT01513317|O1|Outcome|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
214080|NCT01513317|O2|Outcome|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
214081|NCT01513317|O1|Outcome|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
214082|NCT01513317|O2|Outcome|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
214083|NCT01513317|O1|Outcome|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
214084|NCT01513317|O2|Outcome|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
214085|NCT01513317|O1|Outcome|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
214086|NCT01513317|O2|Outcome|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
214087|NCT01513317|O1|Outcome|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
214088|NCT01513317|E2|Reported Event|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
214089|NCT01513317|E1|Reported Event|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
214090|NCT01513291|B3|Baseline|Total|Total of all reporting groups
214091|NCT01513291|B2|Baseline|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
214092|NCT01513291|B1|Baseline|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
214093|NCT01513291|P5|Participant Flow|Run-out Period: Placebo / Placebo|Participants who received placebo and completed the Treatment Period, received double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
214094|NCT01513291|P4|Participant Flow|Run-out Period: MK-6096 / Placebo|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
214095|NCT01513291|P3|Participant Flow|Run-out Period: MK-6096 / MK-6096|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period.
214096|NCT01513291|P2|Participant Flow|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
214097|NCT01513291|P1|Participant Flow|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
214098|NCT01513291|O2|Outcome|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
214099|NCT01513291|O1|Outcome|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
214100|NCT01513291|O2|Outcome|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
214101|NCT01513291|O1|Outcome|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
214102|NCT01513291|O2|Outcome|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
214103|NCT01513291|O1|Outcome|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
214104|NCT01513291|O5|Outcome|Run-out Period: Placebo / Placebo|Participants who received placebo and completed the Treatment Period, received double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
214105|NCT01513291|O4|Outcome|Run-out Period: MK-6096 / Placebo|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
214106|NCT01513291|O3|Outcome|Run-out Period: MK-6096 / MK-6096|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period.
214107|NCT01513291|O2|Outcome|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
214109|NCT01513291|O5|Outcome|Run-out Period: Placebo / Placebo|Participants who received placebo and completed the Treatment Period, received double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
214110|NCT01513291|O4|Outcome|Run-out Period: MK-6096 / Placebo|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
214111|NCT01513291|O3|Outcome|Run-out Period: MK-6096 / MK-6096|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period.
214112|NCT01513291|O2|Outcome|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
214113|NCT01513291|O1|Outcome|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
214114|NCT01513291|O2|Outcome|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
214115|NCT01513291|O1|Outcome|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
214116|NCT01513291|E5|Reported Event|Run-out Period: Placebo / Placebo|Participants who received placebo and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
214117|NCT01513291|E4|Reported Event|Run-out Period: MK-6096 / Placebo|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
214118|NCT01513291|E3|Reported Event|Run-out Period: MK-6096 / MK-6096|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period.
214119|NCT01513291|E2|Reported Event|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
214120|NCT01513291|E1|Reported Event|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
214121|NCT01513239|B4|Baseline|Total|Total of all reporting groups
214122|NCT01513239|B3|Baseline|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
214123|NCT01513239|B2|Baseline|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
214124|NCT01513239|B1|Baseline|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
214125|NCT01513239|P6|Participant Flow|Placebo + SOC 9-ME|9-ME for participants treated with Placebo
214126|NCT01513239|P5|Participant Flow|MK-6072 + SOC 9-ME|9-ME for participants treated with a single IV infusion of 10 mg/kg MK-6072 + SOC
214127|NCT01513239|P4|Participant Flow|MK-3415A + SOC 9-ME|9 Month Extension (9-ME) for participants treated with a single IV infusion of 10 mg/kg MK-3415A + SOC
214128|NCT01513239|P3|Participant Flow|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
214129|NCT01513239|P2|Participant Flow|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
214130|NCT01513239|P1|Participant Flow|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
214131|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
214132|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
214133|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
214134|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
214135|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
214136|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
214137|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
214138|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
214139|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
214140|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
214141|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
214142|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
214143|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
214144|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
214145|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
214146|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
214147|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
214148|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
214149|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
214150|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
214151|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
214152|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
214153|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
214154|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
214155|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
214156|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
214157|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
214158|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
214172|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
214173|NCT01513239|E7|Reported Event|Placebo + SOC 9-ME|9-ME for participants treated with Placebo
214174|NCT01513239|E6|Reported Event|MK-6072 + SOC 9-ME|9-ME for participants treated with a single IV infusion of 10 mg/kg MK-6072 + SOC
214175|NCT01513239|E5|Reported Event|MK-3415A + SOC 9-ME|9 Month Extension (9-ME) for participants treated with a single IV infusion of 10 mg/kg MK-3415A + SOC
214176|NCT01513239|E4|Reported Event|MK-3415 + SOC|Single IV infusion of 10 mg/kg MK-3415 + SOC for CDI
214177|NCT01513239|E3|Reported Event|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
214178|NCT01513239|E2|Reported Event|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
214179|NCT01513239|E1|Reported Event|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK 3415A + SOC for CDI
214180|NCT01513148|B3|Baseline|Total|Total of all reporting groups
214181|NCT01513148|B2|Baseline|Sham Irradiation|Sham Irradiation over the Superficial Radial Nerve for the same time period as the intervention group
214182|NCT01513148|B1|Baseline|Light Therapy|Application of super luminous diodes light irradiation over the superficial radial nerve
214183|NCT01513148|P2|Participant Flow|Sham Irradiation|Sham Irradiation over the Superficial Radial Nerve for the same time period as the intervention group
214184|NCT01513148|P1|Participant Flow|Light Therapy|Application of super luminous diodes light irradiation over the superficial radial nerve
214185|NCT01513148|O14|Outcome|Sham Temp Time 10|Temperature 10 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
214186|NCT01513148|O13|Outcome|Sham Temp Time 8|Temperature 8 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
214187|NCT01513148|O12|Outcome|Sham Temp Time 6|Temperature 6 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
214188|NCT01513148|O11|Outcome|Sham Temp Time 4|Temperature 4 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
214189|NCT01513148|O10|Outcome|Sham Temp Time 2|Temperature 2 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
214190|NCT01513148|O9|Outcome|Sham Temp Time 0|Temperature immediately following the application of sham superluminous diodes light irradiation over the superficial radial nerve
214191|NCT01513148|O8|Outcome|Sham Temp Pretreatment|Temperature prior to the application of sham super luminous diodes light irradiation over the superficial radial nerve
214192|NCT01513148|O7|Outcome|Light Temp Time 10|Temperature 10 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
214193|NCT01513148|O6|Outcome|Light Temp Time 8|Temperature 8 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
214194|NCT01513148|O5|Outcome|Light Temp Time 6|Temperature 6 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
214195|NCT01513148|O4|Outcome|Light Temp Time 4|Temperature 4 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
214196|NCT01513148|O3|Outcome|Light Temp Time 2|Temperature 2 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
214197|NCT01513148|O2|Outcome|Light Temp Time 0|Temperature immediately following the application of superluminous diodes light irradiation over the superficial radial nerve
214198|NCT01513148|O1|Outcome|Light Temp Pretreatment|Temperature prior to the application of super luminous diodes light irradiation over the superficial radial nerve
214199|NCT01513148|O14|Outcome|Sham NPL Pretreatment|NPL for Sham treatment group (Sham Superluminous diode light therapy) at baseline (pretreatment)
214200|NCT01513148|O13|Outcome|Sham NPL Time 10|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 10 minutes
214201|NCT01513148|O12|Outcome|Sham NPL Time 8|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 8 minutes
214202|NCT01513148|O11|Outcome|Sham NPL Time 6|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 6 minutes
214203|NCT01513148|O10|Outcome|Sham NPL Time 4|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 4 minutes
214204|NCT01513148|O9|Outcome|Sham NPL Time 2|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 2 minutes
214205|NCT01513148|O8|Outcome|Sham NPL Time 0|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 0 minutes
214206|NCT01513148|O7|Outcome|Light NPL Time 10|NPL for treatment group (Superluminous diode light therapy) at time 10 minutes
214207|NCT01513148|O6|Outcome|Light NPL Time 8|NPL for treatment group (Superluminous diode light therapy) at time 8 minutes
214208|NCT01513148|O5|Outcome|Light NPL Time 6|NPL for treatment group (Superluminous diode light therapy) at time 6 minutes
214209|NCT01513148|O4|Outcome|Light NPL Time 4|NPL for treatment group (Superluminous diode light therapy) at time 4 minutes
214210|NCT01513148|O3|Outcome|Light NPL Time 2|NPL for treatment group (Superluminous diode light therapy) at time 2 minutes
214211|NCT01513148|O2|Outcome|Light NPL Time 0|NPL for treatment group (Superluminous diode light therapy) at time 0 minutes
214212|NCT01513148|O1|Outcome|Light NPL Pre-treatment|NPL for treatment group (Superluminous diode light therapy) at baseline (pre-treatment)
214213|NCT01513148|O14|Outcome|Sham NCV Time 10|NCV 10 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
214214|NCT01513148|O13|Outcome|Sham NCV Time 8|NCV 8 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
214215|NCT01513148|O12|Outcome|Sham NCV Time 6|NCV 6 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
214216|NCT01513148|O11|Outcome|Sham NCV Time 4|NCV 4 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
214217|NCT01513148|O10|Outcome|Sham NCV Time 2|NCV 2 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
214218|NCT01513148|O9|Outcome|Sham NCV Time 0|NCV immediately (Time 0) following the application of superluminous diodes light irradiation over the superficial radial nerve
214219|NCT01513148|O8|Outcome|Sham NCV Pretreatment|NCV at baseline, before the application of sham superluminous diodes light irradiation over the superficial radial nerve
214220|NCT01513148|O7|Outcome|Light NCV Time 10|NCV 10 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
214221|NCT01513148|O6|Outcome|Light NCV Time 8|NCV 8 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
214222|NCT01513148|O5|Outcome|Light NCV Time 6|NCV 6 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
214223|NCT01513148|O4|Outcome|Light NCV Time 4|NCV 4 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
214224|NCT01513148|O3|Outcome|Light NCV Time 2|NCV 2 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
214225|NCT01513148|O2|Outcome|Light NCV Time 0|NCV at time 0, immediately following the application of super luminous diodes light irradiation over the superficial radial nerve
214226|NCT01513148|O1|Outcome|Light NCV Pretreatment|NCV at baseline, before the application of super luminous diodes light irradiation over the superficial radial nerve
214227|NCT01513148|E2|Reported Event|Sham Irradiation|Sham Irradiation over the Superficial Radial Nerve for the same time period as the intervention group
214228|NCT01513148|E1|Reported Event|Light Therapy|Application of super luminous diodes light irradiation over the superficial radial nerve
214229|NCT01513122|B3|Baseline|Total|Total of all reporting groups
214230|NCT01513122|B2|Baseline|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
214231|NCT01513122|B1|Baseline|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
214232|NCT01513122|P2|Participant Flow|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
214233|NCT01513122|P1|Participant Flow|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
214234|NCT01513122|O2|Outcome|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
214235|NCT01513122|O1|Outcome|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
214236|NCT01513122|O2|Outcome|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
214237|NCT01513122|O1|Outcome|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
214238|NCT01513122|O2|Outcome|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
214239|NCT01513122|O1|Outcome|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
214240|NCT01513122|O2|Outcome|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
214241|NCT01513122|O1|Outcome|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
214242|NCT01513122|O2|Outcome|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
214243|NCT01513122|O1|Outcome|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
214244|NCT01513122|O2|Outcome|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
214245|NCT01513122|O1|Outcome|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
214246|NCT01513122|E2|Reported Event|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
214247|NCT01513122|E1|Reported Event|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
214248|NCT01512979|B3|Baseline|Total|Total of all reporting groups
214249|NCT01512979|B2|Baseline|Linagliptin 5mg|Patients treated with linagliptin 5mg
214250|NCT01512979|B1|Baseline|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
214251|NCT01512979|P2|Participant Flow|Linagliptin 5mg|Patients treated with linagliptin 5mg
214252|NCT01512979|P1|Participant Flow|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
214253|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
214254|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
214255|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
214256|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
214257|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
214258|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
214259|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
215037|NCT01510158|E3|Reported Event|Placebo + Allopurinol|placebo qd plus allopurinol
214260|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
214261|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
214262|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
214263|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
214264|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
214265|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
214266|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
214267|NCT01512979|E2|Reported Event|Linagliptin 5mg|Patients treated with linagliptin 5mg
214268|NCT01512979|E1|Reported Event|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
214269|NCT01512849|B3|Baseline|Total|Total of all reporting groups
214270|NCT01512849|B2|Baseline|Entire Population for Normal Renal Function|
214271|NCT01512849|B1|Baseline|Entire Population for Moderate Renal Impairment|
214272|NCT01512849|P4|Participant Flow|Normal Renal Function High Dose First|TA-7284 High dose in Period 1, then crossover to TA-7284 Low dose in Period 2
214273|NCT01512849|P3|Participant Flow|Normal Renal Function Low Dose First|TA-7284 Low dose in Period 1, then crossover to TA-7284 High dose in Period 2
214274|NCT01512849|P2|Participant Flow|Moderate Renal Impairment High Dose First|TA-7284 High dose in Period 1, then crossover to TA-7284 Low dose in Period 2
214275|NCT01512849|P1|Participant Flow|Moderate Renal Impairment Low Dose First|TA-7284 Low dose in Period 1, then crossover to TA-7284 High dose in Period 2
214276|NCT01512849|O4|Outcome|Normal Renal Function High|TA-7284-High was administered in a single dose.
214277|NCT01512849|O3|Outcome|Normal Renal Function Low|TA-7284-Low was administered in a single dose.
214278|NCT01512849|O2|Outcome|Moderate Renal Impairment High|TA-7284-High was administered in a single dose.
214279|NCT01512849|O1|Outcome|Moderate Renal Impairment Low|TA-7284-Low was administered in a single dose.
214280|NCT01512849|O4|Outcome|Normal Renal Function High|TA-7284-High was administered in a single dose.
214281|NCT01512849|O3|Outcome|Normal Renal Function Low|TA-7284-Low was administered in a single dose.
214282|NCT01512849|O2|Outcome|Moderate Renal Impairment High|TA-7284-High was administered in a single dose.
214283|NCT01512849|O1|Outcome|Moderate Renal Impairment Low|TA-7284-Low was administered in a single dose.
214284|NCT01512849|O4|Outcome|Normal Renal Function High|TA-7284-High was administered in a single dose.
214285|NCT01512849|O3|Outcome|Normal Renal Function Low|TA-7284-Low was administered in a single dose.
214286|NCT01512849|O2|Outcome|Moderate Renal Impairment High|TA-7284-High was administered in a single dose.
214287|NCT01512849|O1|Outcome|Moderate Renal Impairment Low|TA-7284-Low was administered in a single dose.
214288|NCT01512849|O4|Outcome|Normal Renal Function High|TA-7284-High was administered in a single dose.
214289|NCT01512849|O3|Outcome|Normal Renal Function Low|TA-7284-Low was administered in a single dose.
214290|NCT01512849|O2|Outcome|Moderate Renal Impairment High|TA-7284-High was administered in a single dose.
214291|NCT01512849|O1|Outcome|Moderate Renal Impairment Low|TA-7284-Low was administered in a single dose.
214292|NCT01512849|E4|Reported Event|Normal Renal Function High|TA-7284-High was administered in a single dose.
214293|NCT01512849|E3|Reported Event|Normal Renal Function Low|TA-7284-Low was administered in a single dose.
214294|NCT01512849|E2|Reported Event|Moderate Renal Impairment High|TA-7284-High was administered in a single dose.
214295|NCT01512849|E1|Reported Event|Moderate Renal Impairment Low|TA-7284-Low was administered in a single dose.
214296|NCT01512797|B3|Baseline|Total|Total of all reporting groups
214297|NCT01512797|B2|Baseline|Placebo|"1 Placebo pill / day PO once a day for 4-5 weeks~Placebo: 1 Placebo Pill per day"
214298|NCT01512797|B1|Baseline|Sitagliptin Phosphate|"100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks~Sitagliptin phosphate: 100 mg/day orally"
214299|NCT01512797|P2|Participant Flow|Placebo|"1 Placebo pill / day PO once a day for 4-5 weeks~Placebo: 1 Placebo Pill per day"
214300|NCT01512797|P1|Participant Flow|Sitagliptin Phosphate|"100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks~Sitagliptin phosphate: 100 mg/day orally"
214301|NCT01512797|O2|Outcome|Placebo|"1 Placebo pill / day PO once a day for 4-5 weeks~Placebo: 1 Placebo Pill per day"
214302|NCT01512797|O1|Outcome|Sitagliptin Phosphate|"100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks~Sitagliptin phosphate: 100 mg/day orally"
214303|NCT01512797|O2|Outcome|Placebo|"1 Placebo pill / day PO once a day for 4-5 weeks~Placebo: 1 Placebo Pill per day"
214304|NCT01512797|O1|Outcome|Sitagliptin Phosphate|"100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks~Sitagliptin phosphate: 100 mg/day orally"
214305|NCT01512797|O2|Outcome|Placebo|"1 Placebo pill / day PO once a day for 4-5 weeks~Placebo: 1 Placebo Pill per day"
214306|NCT01512797|O1|Outcome|Sitagliptin Phosphate|"100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks~Sitagliptin phosphate: 100 mg/day orally"
214307|NCT01512797|O2|Outcome|Placebo|"1 Placebo pill / day PO once a day for 4-5 weeks~Placebo: 1 Placebo Pill per day"
214308|NCT01512797|O1|Outcome|Sitagliptin Phosphate|"100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks~Sitagliptin phosphate: 100 mg/day orally"
214309|NCT01512797|O2|Outcome|Placebo|"1 Placebo pill / day PO once a day for 4-5 weeks~Placebo: 1 Placebo Pill per day"
214310|NCT01512797|O1|Outcome|Sitagliptin Phosphate|"100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks~Sitagliptin phosphate: 100 mg/day orally"
214311|NCT01512797|E2|Reported Event|Placebo|"1 Placebo pill / day PO once a day for 4-5 weeks~Placebo: 1 Placebo Pill per day"
214312|NCT01512797|E1|Reported Event|Sitagliptin Phosphate|"100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks~Sitagliptin phosphate: 100 mg/day orally"
214313|NCT01512745|B3|Baseline|Total|Total of all reporting groups
214314|NCT01512745|B2|Baseline|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
214315|NCT01512745|B1|Baseline|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
214316|NCT01512745|P2|Participant Flow|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
214317|NCT01512745|P1|Participant Flow|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
214318|NCT01512745|O2|Outcome|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
214319|NCT01512745|O1|Outcome|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
214320|NCT01512745|O2|Outcome|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
214321|NCT01512745|O1|Outcome|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
214322|NCT01512745|O2|Outcome|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
214323|NCT01512745|O1|Outcome|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
214324|NCT01512745|O2|Outcome|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
214325|NCT01512745|O1|Outcome|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
214326|NCT01512745|O2|Outcome|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
214327|NCT01512745|O1|Outcome|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
214328|NCT01512745|E2|Reported Event|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
214329|NCT01512745|E1|Reported Event|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
214330|NCT01512693|B3|Baseline|Total|Total of all reporting groups
214331|NCT01512693|B2|Baseline|Healthy Matched Control Group|Single-dose administration of odanacatib 50 mg to healthy matched control participants.
214332|NCT01512693|B1|Baseline|Moderate Hepatic Insufficiency Group|Single-dose administration of odanacatib 50 mg to participants with moderate hepatic insufficiency.
214333|NCT01512693|P2|Participant Flow|Healthy Matched Control Group|Single-dose administration of odanacatib 50 mg to healthy matched control participants.
214334|NCT01512693|P1|Participant Flow|Moderate Hepatic Insufficiency Group|Single-dose administration of odanacatib 50 mg to participants with moderate hepatic insufficiency.
214335|NCT01512693|O2|Outcome|Healthy Matched Control Group|Single-dose administration of odanacatib 50 mg to healthy matched control participants.
214336|NCT01512693|O1|Outcome|Moderate Hepatic Insufficiency Group|Single-dose administration of odanacatib 50 mg to participants with moderate hepatic insufficiency.
214337|NCT01512693|O2|Outcome|Healthy Matched Control Group|Single-dose administration of odanacatib 50 mg to healthy matched control participants.
214338|NCT01512693|O1|Outcome|Moderate Hepatic Insufficiency Group|Single-dose administration of odanacatib 50 mg to participants with moderate hepatic insufficiency.
214339|NCT01512693|O2|Outcome|Healthy Matched Control Group|Single-dose administration of odanacatib 50 mg to healthy matched control participants.
214340|NCT01512693|O1|Outcome|Moderate Hepatic Insufficiency Group|Single-dose administration of odanacatib 50 mg to participants with moderate hepatic insufficiency.
214341|NCT01512693|O2|Outcome|Healthy Matched Control Group|Single-dose administration of odanacatib 50 mg to healthy matched control participants.
214342|NCT01512693|O1|Outcome|Moderate Hepatic Insufficiency Group|Single-dose administration of odanacatib 50 mg to participants with moderate hepatic insufficiency.
214343|NCT01512693|E2|Reported Event|Healthy Matched Control Group|Single-dose administration of odanacatib 50 mg to healthy matched control participants.
214344|NCT01512693|E1|Reported Event|Moderate Hepatic Insufficiency Group|Single-dose administration of odanacatib 50 mg to participants with moderate hepatic insufficiency.
214345|NCT01512667|B3|Baseline|Total|Total of all reporting groups
214346|NCT01512667|B2|Baseline|Healthy Matched Control Group|Single-dose administration of odanacatib 50 mg to healthy matched control participants.
214347|NCT01512667|B1|Baseline|Severe Renal Insufficiency Group|Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency.
214348|NCT01512667|P2|Participant Flow|Healthy Matched Control Group|Single-dose administration of odanacatib 50 mg to healthy matched control participants.
214349|NCT01512667|P1|Participant Flow|Severe Renal Insufficiency Group|Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency.
214350|NCT01512667|O2|Outcome|Healthy Matched Control Group|Single-dose administration of odanacatib 50 mg to healthy matched control participants.
214351|NCT01512667|O1|Outcome|Severe Renal Insufficiency Group|Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency.
214352|NCT01512667|O2|Outcome|Healthy Matched Control Group|Single-dose administration of odanacatib 50 mg to healthy matched control participants.
214353|NCT01512667|O1|Outcome|Severe Renal Insufficiency Group|Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency.
214354|NCT01512667|O2|Outcome|Healthy Matched Control Group|Single-dose administration of odanacatib 50 mg to healthy matched control participants.
214355|NCT01512667|O1|Outcome|Severe Renal Insufficiency Group|Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency.
214356|NCT01512667|O2|Outcome|Healthy Matched Control Group|Single-dose administration of odanacatib 50 mg to healthy matched control participants.
214357|NCT01512667|O1|Outcome|Severe Renal Insufficiency Group|Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency.
215038|NCT01510158|E2|Reported Event|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
214358|NCT01512667|E2|Reported Event|Healthy Matched Control Group|Single-dose administration of odanacatib 50 mg to healthy matched control participants.
214359|NCT01512667|E1|Reported Event|Severe Renal Insufficiency Group|Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency.
214360|NCT01512368|B1|Baseline|Supervised Exercising|A treadmill exercise test (following the Bruce’s protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
214361|NCT01512368|P1|Participant Flow|Supervised Exercising|A treadmill exercise test (following the Bruce’s protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
214362|NCT01512368|O1|Outcome|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
214363|NCT01512368|O1|Outcome|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
214364|NCT01512368|O1|Outcome|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
214365|NCT01512368|O1|Outcome|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
214366|NCT01512368|O1|Outcome|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
214367|NCT01512368|O1|Outcome|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
214368|NCT01512368|E1|Reported Event|Supervised Exercising|A treadmill exercise test (following the Bruce’s protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
214369|NCT01512251|B3|Baseline|Total|Total of all reporting groups
214370|NCT01512251|B2|Baseline|Vemurafenib-Resistant|
214371|NCT01512251|B1|Baseline|Vemurafenib-Naïve|
214372|NCT01512251|P2|Participant Flow|Vemurafenib-Resistant|"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~Dose Level -1:~BKM120 60 mg daily Vemurafenib 480 mg bid~Phase I, Dose Level 1:~BKM120 60 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 2:~BKM120 80 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 3:~BKM120 100 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid~Phase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~BKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)"
214373|NCT01512251|P1|Participant Flow|Vemurafenib-Naïve|"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~Dose Level -1:~BKM120 60 mg daily Vemurafenib 480 mg bid~Phase I, Dose Level 1:~BKM120 60 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 2:~BKM120 80 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 3:~BKM120 100 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid~Phase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~BKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)"
214374|NCT01512251|O2|Outcome|Vemurafenib-Resistant|"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~Dose Level -1:~BKM120 60 mg daily Vemurafenib 480 mg bid~Phase I, Dose Level 1:~BKM120 60 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 2:~BKM120 80 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 3:~BKM120 100 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid~Phase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~BKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)"
214375|NCT01512251|O1|Outcome|Vemurafenib-Naïve|"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~Dose Level -1:~BKM120 60 mg daily Vemurafenib 480 mg bid~Phase I, Dose Level 1:~BKM120 60 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 2:~BKM120 80 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 3:~BKM120 100 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid~Phase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~BKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)"
214376|NCT01512251|O2|Outcome|Vemurafenib-Resistant|"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~Dose Level -1:~BKM120 60 mg daily Vemurafenib 480 mg bid~Phase I, Dose Level 1:~BKM120 60 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 2:~BKM120 80 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 3:~BKM120 100 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid~Phase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~BKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)"
214377|NCT01512251|O1|Outcome|Vemurafenib-Naïve|"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~Dose Level -1:~BKM120 60 mg daily Vemurafenib 480 mg bid~Phase I, Dose Level 1:~BKM120 60 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 2:~BKM120 80 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 3:~BKM120 100 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid~Phase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~BKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)"
214378|NCT01512251|O2|Outcome|Vemurafenib-Resistant|"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~Dose Level -1:~BKM120 60 mg daily Vemurafenib 480 mg bid~Phase I, Dose Level 1:~BKM120 60 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 2:~BKM120 80 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 3:~BKM120 100 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid~Phase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~BKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)"
215039|NCT01510158|E1|Reported Event|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
214379|NCT01512251|O1|Outcome|Vemurafenib-Naïve|"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~Dose Level -1:~BKM120 60 mg daily Vemurafenib 480 mg bid~Phase I, Dose Level 1:~BKM120 60 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 2:~BKM120 80 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 3:~BKM120 100 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid~Phase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~BKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)"
214380|NCT01512251|O2|Outcome|Vemurafenib-Resistant|"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~Dose Level -1:~BKM120 60 mg daily Vemurafenib 480 mg bid~Phase I, Dose Level 1:~BKM120 60 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 2:~BKM120 80 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 3:~BKM120 100 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid~Phase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~BKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)"
214381|NCT01512251|O1|Outcome|Vemurafenib-Naïve|"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~Dose Level -1:~BKM120 60 mg daily Vemurafenib 480 mg bid~Phase I, Dose Level 1:~BKM120 60 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 2:~BKM120 80 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 3:~BKM120 100 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid~Phase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~BKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)"
214382|NCT01512251|O2|Outcome|Vemurafenib-Resistant|"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~Dose Level -1:~BKM120 60 mg daily Vemurafenib 480 mg bid~Phase I, Dose Level 1:~BKM120 60 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 2:~BKM120 80 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 3:~BKM120 100 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid~Phase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~BKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)"
214383|NCT01512251|O1|Outcome|Vemurafenib-Naïve|"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~Dose Level -1:~BKM120 60 mg daily Vemurafenib 480 mg bid~Phase I, Dose Level 1:~BKM120 60 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 2:~BKM120 80 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 3:~BKM120 100 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid~Phase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~BKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)"
214384|NCT01512251|O2|Outcome|Vemurafenib-Resistant|"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~Dose Level -1:~BKM120 60 mg daily Vemurafenib 480 mg bid~Phase I, Dose Level 1:~BKM120 60 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 2:~BKM120 80 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 3:~BKM120 100 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid~Phase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~BKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)"
214385|NCT01512251|O1|Outcome|Vemurafenib-Naïve|"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~Dose Level -1:~BKM120 60 mg daily Vemurafenib 480 mg bid~Phase I, Dose Level 1:~BKM120 60 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 2:~BKM120 80 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 3:~BKM120 100 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid~Phase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~BKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)"
214386|NCT01512251|O2|Outcome|Vemurafenib-Resistant|"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~Dose Level -1:~BKM120 60 mg daily Vemurafenib 480 mg bid~Phase I, Dose Level 1:~BKM120 60 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 2:~BKM120 80 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 3:~BKM120 100 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid~Phase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~BKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)"
214387|NCT01512251|O1|Outcome|Vemurafenib-Naïve|"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~Dose Level -1:~BKM120 60 mg daily Vemurafenib 480 mg bid~Phase I, Dose Level 1:~BKM120 60 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 2:~BKM120 80 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 3:~BKM120 100 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid~Phase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~BKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)"
214388|NCT01512251|O1|Outcome|Determination of MTD|"Vemurafenib-Naïve and Vemurafenib-Resistant populations received:~150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~Dose Level -1:~BKM120 60 mg daily Vemurafenib 480 mg bid~Phase I, Dose Level 1:~BKM120 60 mg daily Vemurafenib 720 mg bid"
214389|NCT01512251|E2|Reported Event|Vemurafenib-Resistant|"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~Dose Level -1:~BKM120 60 mg daily Vemurafenib 480 mg bid~Phase I, Dose Level 1:~BKM120 60 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 2:~BKM120 80 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 3:~BKM120 100 mg daily Vemurafenib 720 mg bid Phase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid Phase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~BKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)"
215265|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
214390|NCT01512251|E1|Reported Event|Vemurafenib-Naïve|"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~Dose Level -1:~BKM120 60 mg daily Vemurafenib 480 mg bid~Phase I, Dose Level 1:~BKM120 60 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 2:~BKM120 80 mg daily Vemurafenib 720 mg bid~Phase I, Dose Level 3:~BKM120 100 mg daily Vemurafenib 720 mg bid Phase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid Phase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.~BKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)"
214391|NCT01512225|B3|Baseline|Total|Total of all reporting groups
214392|NCT01512225|B2|Baseline|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days~Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
214393|NCT01512225|B1|Baseline|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days~Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
214394|NCT01512225|P2|Participant Flow|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days~Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
214395|NCT01512225|P1|Participant Flow|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days~Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
214396|NCT01512225|O2|Outcome|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days~Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
214397|NCT01512225|O1|Outcome|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days~Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
214398|NCT01512225|O2|Outcome|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days~Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
214399|NCT01512225|O1|Outcome|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days~Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
214400|NCT01512225|O2|Outcome|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days~Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
214401|NCT01512225|O1|Outcome|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days~Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
214402|NCT01512225|O2|Outcome|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days~Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
214403|NCT01512225|O1|Outcome|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days~Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
214404|NCT01512225|O2|Outcome|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days~Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
214405|NCT01512225|O1|Outcome|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days~Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
214406|NCT01512225|O2|Outcome|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days~Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
214407|NCT01512225|O1|Outcome|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days~Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
214408|NCT01512225|O2|Outcome|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days~Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
214409|NCT01512225|O1|Outcome|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days~Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
214410|NCT01512225|O2|Outcome|Group B: Placebo + Domperidone|Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days
214411|NCT01512225|O1|Outcome|Group A: Domperidone|Domperidone 10 mg orally three times daily for 28 days
214412|NCT01512225|E2|Reported Event|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days~Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
214413|NCT01512225|E1|Reported Event|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days~Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
214414|NCT01512160|B5|Baseline|Total|Total of all reporting groups
214415|NCT01512160|B4|Baseline|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214512|NCT01512108|B2|Baseline|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
214416|NCT01512160|B3|Baseline|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214417|NCT01512160|B2|Baseline|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214418|NCT01512160|B1|Baseline|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214419|NCT01512160|P4|Participant Flow|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214420|NCT01512160|P3|Participant Flow|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214421|NCT01512160|P2|Participant Flow|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214422|NCT01512160|P1|Participant Flow|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 milligram (mg) spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 millimeter (mm) on a 100 mm Visual Analogue Scale (VAS).
214423|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214424|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214425|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214426|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214427|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214428|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214429|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214430|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214431|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214432|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214433|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214434|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214435|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214436|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214437|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214438|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214439|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214440|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214441|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214442|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214443|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214444|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214445|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214446|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214447|NCT01512160|O1|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214448|NCT01512160|O1|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214449|NCT01512160|O1|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214450|NCT01512160|O1|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214451|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214452|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214453|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
215266|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
214454|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214455|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214456|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214457|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214458|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214459|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214460|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214461|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214462|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214463|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214464|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214465|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214466|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214467|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214468|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214469|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214470|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214471|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214472|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
215650|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
214473|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214474|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214475|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214476|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214477|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214478|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214479|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214480|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214481|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214482|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214483|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214484|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214485|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214486|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214487|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214488|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214489|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214490|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214491|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
215651|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
214492|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214493|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214494|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214495|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214496|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214497|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214498|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214499|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214500|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214501|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214502|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214503|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214504|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214505|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214506|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214507|NCT01512160|E4|Reported Event|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214508|NCT01512160|E3|Reported Event|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214509|NCT01512160|E2|Reported Event|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214510|NCT01512160|E1|Reported Event|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
214511|NCT01512108|B3|Baseline|Total|Total of all reporting groups
214513|NCT01512108|B1|Baseline|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
214514|NCT01512108|P2|Participant Flow|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
214515|NCT01512108|P1|Participant Flow|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
214516|NCT01512108|O2|Outcome|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
214517|NCT01512108|O1|Outcome|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
214518|NCT01512108|O2|Outcome|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
214519|NCT01512108|O1|Outcome|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
214520|NCT01512108|O2|Outcome|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
214521|NCT01512108|O1|Outcome|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
214522|NCT01512108|O2|Outcome|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
214523|NCT01512108|O1|Outcome|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
214524|NCT01512108|E2|Reported Event|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
214525|NCT01512108|E1|Reported Event|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
214526|NCT01511978|B3|Baseline|Total|Total of all reporting groups
214527|NCT01511978|B2|Baseline|3,4-DAP Taper to Placebo|Subjects were administered decreasing amounts of 3,4-DAP on their regular personalized schedule
214528|NCT01511978|B1|Baseline|Continuous 3,4-Diaminopyridine (3,4-DAP)|Subjects were administered their usual dosage on their regular personalized schedule
214529|NCT01511978|P2|Participant Flow|Taper 3,4-DAP to Placebo|Subjects were administered decreasing amounts of 3,4-DAP on their regular personalized schedule
214530|NCT01511978|P1|Participant Flow|Continuous 3,4-DAP|Subjects were administered their usual dosage on their regular personalized schedule
214531|NCT01511978|O2|Outcome|3,4-DAP Taper to Placebo|Subjects were administered decreasing amounts of 3,4-DAP on their regular personalized schedule
214532|NCT01511978|O1|Outcome|3,4-DAP|Subjects were administered their usual dosage on their regular personalized schedule.
214533|NCT01511978|O2|Outcome|3,4-DAP Taper to Placebo|Subjects were tapered off of their pre-randomization 3,4-DAP dosing regimen over 3 days with up to an additional 16 hours of placebo.
214534|NCT01511978|O1|Outcome|Continuous 3,4-Diaminopyridine (3,4-DAP)|Subjects were continued on their usual pre-randomization 3,4-DAP dosing regimen.
214535|NCT01511978|E2|Reported Event|3,4-DAP Taper to Placebo|Subjects were administered decreasing amounts of 3,4-DAP on their regular personalized schedule
214536|NCT01511978|E1|Reported Event|Continuous 3,4-Diaminopyridine (3,4-DAP)|Subjects were administered their usual dosage on their regular personalized schedule
214537|NCT01511939|B4|Baseline|Total|Total of all reporting groups
214538|NCT01511939|B3|Baseline|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
214539|NCT01511939|B2|Baseline|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
215504|NCT01507831|B2|Baseline|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
214540|NCT01511939|B1|Baseline|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
214541|NCT01511939|P3|Participant Flow|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
214542|NCT01511939|P2|Participant Flow|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
214543|NCT01511939|P1|Participant Flow|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if osteoarthritis (OA) pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
214544|NCT01511939|O3|Outcome|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
214545|NCT01511939|O2|Outcome|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
214546|NCT01511939|O1|Outcome|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
214547|NCT01511939|O3|Outcome|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
214548|NCT01511939|O2|Outcome|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
214549|NCT01511939|O1|Outcome|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
214550|NCT01511939|O3|Outcome|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
214551|NCT01511939|O2|Outcome|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
214552|NCT01511939|O1|Outcome|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
214553|NCT01511939|O3|Outcome|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
214600|NCT01511445|O2|Outcome|ACDF With PEEK Interbody Cage|Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic.
214554|NCT01511939|O2|Outcome|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
214555|NCT01511939|O1|Outcome|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
214556|NCT01511939|E3|Reported Event|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
214557|NCT01511939|E2|Reported Event|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
214558|NCT01511939|E1|Reported Event|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
214559|NCT01511809|B3|Baseline|Total|Total of all reporting groups
214560|NCT01511809|B2|Baseline|Atazanavir/Ritonavir Triple Therapy|Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
214561|NCT01511809|B1|Baseline|Atazanavir/Ritonavir Monotherapy|"Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy~Atazanavir/ritonavir monotherapy: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks."
214562|NCT01511809|P2|Participant Flow|Atazanavir/Ritonavir Triple Therapy|Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
214563|NCT01511809|P1|Participant Flow|Atazanavir/Ritonavir Monotherapy|"Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy~Atazanavir/ritonavir monotherapy: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks."
214564|NCT01511809|O2|Outcome|Atazanavir/Ritonavir Triple Therapy|Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
214565|NCT01511809|O1|Outcome|Atazanavir/Ritonavir Monotherapy|"Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy~Atazanavir/ritonavir monotherapy: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks."
214566|NCT01511809|E2|Reported Event|Atazanavir/Ritonavir Triple Therapy|Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
214567|NCT01511809|E1|Reported Event|Atazanavir/Ritonavir Monotherapy|"Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy~Atazanavir/ritonavir monotherapy: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks."
214568|NCT01511536|B4|Baseline|Total|Total of all reporting groups
214569|NCT01511536|B3|Baseline|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
214570|NCT01511536|B2|Baseline|Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
214571|NCT01511536|B1|Baseline|Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
214572|NCT01511536|P3|Participant Flow|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at maximum tolerated dose (MTD) as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
214573|NCT01511536|P2|Participant Flow|Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
214574|NCT01511536|P1|Participant Flow|Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 20 mg/m^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
214575|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
214576|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
214601|NCT01511445|O1|Outcome|ACDF With Valeo CSC Ceramic Cage|ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage.
214577|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
214578|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
214579|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
214580|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
214581|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
214582|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
214583|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
214584|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
214585|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
214586|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
214587|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
214588|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
214589|NCT01511536|O1|Outcome|Phase 1: Overall Population|Cabazitaxel 20 or 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
214590|NCT01511536|E3|Reported Event|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
214591|NCT01511536|E2|Reported Event|Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
214592|NCT01511536|E1|Reported Event|Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
214593|NCT01511445|B3|Baseline|Total|Total of all reporting groups
214594|NCT01511445|B2|Baseline|ACDF With PEEK Interbody Cage|Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic.
214595|NCT01511445|B1|Baseline|ACDF With Valeo CSC Ceramic Cage|ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage.
214596|NCT01511445|P2|Participant Flow|ACDF With PEEK Interbody Cage|"Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic. The open space in the center of the cage is to be filled with local autologous bone harvested during the decompression phase of the procedure.~Anterior cervical discectomy and fusion (ACDF) with PEEK Cage: Anterior cervical discectomy and fusion with the use of a PEEK plastic interbody spacer"
214597|NCT01511445|P1|Participant Flow|ACDF With Valeo CSC Ceramic Cage|"ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage. The center area of the cage is filled with porous silicon nitride. No autologous bone is used; the cage is soaked in patient blood.~Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage: Anterior cervical discectomy and fusion with a Valeo ceramic cage interbody spacer."
214598|NCT01511445|O2|Outcome|ACDF With PEEK Interbody Cage|Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic.
214599|NCT01511445|O1|Outcome|ACDF With Valeo CSC Ceramic Cage|ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage.
214602|NCT01511445|E2|Reported Event|ACDF With PEEK Interbody Cage|Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic.
214603|NCT01511445|E1|Reported Event|ACDF With Valeo CSC Ceramic Cage|ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage.
214604|NCT01511315|B1|Baseline|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
214605|NCT01511315|P1|Participant Flow|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
214606|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
214607|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
214608|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
214609|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
214610|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
214611|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
214612|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
214613|NCT01511315|E1|Reported Event|Ustekinumab|Ustekinumab: Biologic agent: sub-cutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter.
214614|NCT01511250|B11|Baseline|Total|Total of all reporting groups
214615|NCT01511250|B10|Baseline|Part II: Placebo 1.5 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214616|NCT01511250|B9|Baseline|Part II: TDV 1.5 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214617|NCT01511250|B8|Baseline|Part I: Placebo 1.5 to 5 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214618|NCT01511250|B7|Baseline|Part I: TDV 1.5 to 5 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214619|NCT01511250|B6|Baseline|Part I: Placebo 6 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
214620|NCT01511250|B5|Baseline|Part I: TDV 6 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214621|NCT01511250|B4|Baseline|Part I: Placebo 12 to 20 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
214622|NCT01511250|B3|Baseline|Part I: TDV 12 to 20 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214623|NCT01511250|B2|Baseline|Part I: Placebo 21 to 45 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
214624|NCT01511250|B1|Baseline|Part I: TDV 21 to 45 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214625|NCT01511250|P10|Participant Flow|Part II: Placebo 1.5 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214626|NCT01511250|P9|Participant Flow|Part II: TDV 1.5 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214627|NCT01511250|P8|Participant Flow|Part I: Placebo 1.5 to 5 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214805|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
214628|NCT01511250|P7|Participant Flow|Part I: TDV 1.5 to 5 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214629|NCT01511250|P6|Participant Flow|Part I: Placebo 6 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
214630|NCT01511250|P5|Participant Flow|Part I: TDV 6 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214631|NCT01511250|P4|Participant Flow|Part I: Placebo 12 to 20 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
214632|NCT01511250|P3|Participant Flow|Part I: TDV 12 to 20 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214633|NCT01511250|P2|Participant Flow|Part I: Placebo 21 to 45 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
214634|NCT01511250|P1|Participant Flow|Part I: TDV 21 to 45 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214635|NCT01511250|O10|Outcome|Part II: Placebo 1.5 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214636|NCT01511250|O9|Outcome|Part II: TDV 1.5 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214637|NCT01511250|O8|Outcome|Part I: Placebo 1.5 to 5 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214638|NCT01511250|O7|Outcome|Part I: TDV 1.5 to 5 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214639|NCT01511250|O6|Outcome|Part I: Placebo 6 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
214640|NCT01511250|O5|Outcome|Part I: TDV 6 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214641|NCT01511250|O4|Outcome|Part I: Placebo 12 to 20 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
214642|NCT01511250|O3|Outcome|Part I: TDV 12 to 20 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214643|NCT01511250|O2|Outcome|Part I: Placebo 21 to 45 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
214644|NCT01511250|O1|Outcome|Part I: TDV 21 to 45 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214645|NCT01511250|O10|Outcome|Part II: Placebo 1.5 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214646|NCT01511250|O9|Outcome|Part II: TDV 1.5 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214647|NCT01511250|O8|Outcome|Part I: Placebo 1.5 to 5 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214648|NCT01511250|O7|Outcome|Part I: TDV 1.5 to 5 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214649|NCT01511250|O6|Outcome|Part I: Placebo 6 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
214650|NCT01511250|O5|Outcome|Part I: TDV 6 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214651|NCT01511250|O4|Outcome|Part I: Placebo 12 to 20 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
214652|NCT01511250|O3|Outcome|Part I: TDV 12 to 20 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214653|NCT01511250|O2|Outcome|Part I: Placebo 21 to 45 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
214654|NCT01511250|O1|Outcome|Part I: TDV 21 to 45 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214655|NCT01511250|O10|Outcome|Part II: Placebo 1.5 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214656|NCT01511250|O9|Outcome|Part II: TDV 1.5 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214657|NCT01511250|O8|Outcome|Part I: Placebo 1.5 to 5 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214658|NCT01511250|O7|Outcome|Part I: TDV 1.5 to 5 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214659|NCT01511250|O6|Outcome|Part I: Placebo 6 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
214660|NCT01511250|O5|Outcome|Part I: TDV 6 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214661|NCT01511250|O4|Outcome|Part I: Placebo 12 to 20 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
214662|NCT01511250|O3|Outcome|Part I: TDV 12 to 20 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214663|NCT01511250|O2|Outcome|Part I: Placebo 21 to 45 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
214664|NCT01511250|O1|Outcome|Part I: TDV 21 to 45 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214665|NCT01511250|O10|Outcome|Part II: Placebo 1.5 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214666|NCT01511250|O9|Outcome|Part II: TDV 1.5 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214667|NCT01511250|O8|Outcome|Part I: Placebo 1.5 to 5 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214668|NCT01511250|O7|Outcome|Part I: TDV 1.5 to 5 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214669|NCT01511250|O6|Outcome|Part I: Placebo 6 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
214670|NCT01511250|O5|Outcome|Part I: TDV 6 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214671|NCT01511250|O4|Outcome|Part I: Placebo 12 to 20 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
214672|NCT01511250|O3|Outcome|Part I: TDV 12 to 20 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214673|NCT01511250|O2|Outcome|Part I: Placebo 21 to 45 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
214674|NCT01511250|O1|Outcome|Part I: TDV 21 to 45 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214675|NCT01511250|O10|Outcome|Part II: Placebo 1.5 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214676|NCT01511250|O9|Outcome|Part II: TDV 1.5 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214677|NCT01511250|O8|Outcome|Part I: Placebo 1.5 to 5 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214678|NCT01511250|O7|Outcome|Part I: TDV 1.5 to 5 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214679|NCT01511250|O6|Outcome|Part I: Placebo 6 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
214680|NCT01511250|O5|Outcome|Part I: TDV 6 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214681|NCT01511250|O4|Outcome|Part I: Placebo 12 to 20 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
214682|NCT01511250|O3|Outcome|Part I: TDV 12 to 20 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214683|NCT01511250|O2|Outcome|Part I: Placebo 21 to 45 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
214684|NCT01511250|O1|Outcome|Part I: TDV 21 to 45 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214685|NCT01511250|O8|Outcome|Part I: Placebo 1.5 to 5 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214686|NCT01511250|O7|Outcome|Part I: TDV 1.5 to 5 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214687|NCT01511250|O6|Outcome|Part I: Placebo 6 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
214688|NCT01511250|O5|Outcome|Part I: TDV 6 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214689|NCT01511250|O4|Outcome|Part I: Placebo 12 to 20 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
214690|NCT01511250|O3|Outcome|Part I: TDV 12 to 20 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214691|NCT01511250|O2|Outcome|Part I: Placebo 21 to 45 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
214692|NCT01511250|O1|Outcome|Part I: TDV 21 to 45 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214693|NCT01511250|O8|Outcome|Part I: Placebo 1.5 to 5 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214694|NCT01511250|O7|Outcome|Part I: TDV 1.5 to 5 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214695|NCT01511250|O6|Outcome|Part I: Placebo 6 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
214696|NCT01511250|O5|Outcome|Part I: TDV 6 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214697|NCT01511250|O4|Outcome|Part I: Placebo 12 to 20 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
214698|NCT01511250|O3|Outcome|Part I: TDV 12 to 20 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214699|NCT01511250|O2|Outcome|Part I: Placebo 21 to 45 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
215652|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
214700|NCT01511250|O1|Outcome|Part I: TDV 21 to 45 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214701|NCT01511250|O8|Outcome|Part I: Placebo 1.5 to 5 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214702|NCT01511250|O7|Outcome|Part I: TDV 1.5 to 5 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214703|NCT01511250|O6|Outcome|Part I: Placebo 6 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
214704|NCT01511250|O5|Outcome|Part I: TDV 6 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214705|NCT01511250|O4|Outcome|Part I: Placebo 12 to 20 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
214706|NCT01511250|O3|Outcome|Part I: TDV 12 to 20 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214707|NCT01511250|O2|Outcome|Part I: Placebo 21 to 45 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
214708|NCT01511250|O1|Outcome|Part I: TDV 21 to 45 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214709|NCT01511250|O10|Outcome|Part II: Placebo 1.5 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214710|NCT01511250|O9|Outcome|Part II: TDV 1.5 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214711|NCT01511250|O8|Outcome|Part I: Placebo 1.5 to 5 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214712|NCT01511250|O7|Outcome|Part I: TDV 1.5 to 5 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214713|NCT01511250|O6|Outcome|Part I: Placebo 6 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
214714|NCT01511250|O5|Outcome|Part I: TDV 6 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214715|NCT01511250|O4|Outcome|Part I: Placebo 12 to 20 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
214716|NCT01511250|O3|Outcome|Part I: TDV 12 to 20 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214717|NCT01511250|O2|Outcome|Part I: Placebo 21 to 45 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
214718|NCT01511250|O1|Outcome|Part I: TDV 21 to 45 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214719|NCT01511250|O10|Outcome|Part II: Placebo 1.5 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214720|NCT01511250|O9|Outcome|Part II: TDV 1.5 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214721|NCT01511250|O8|Outcome|Part I: Placebo 1.5 to 5 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214722|NCT01511250|O7|Outcome|Part I: TDV 1.5 to 5 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214723|NCT01511250|O6|Outcome|Part I: Placebo 6 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
215653|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
214724|NCT01511250|O5|Outcome|Part I: TDV 6 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214725|NCT01511250|O4|Outcome|Part I: Placebo 12 to 20 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
214726|NCT01511250|O3|Outcome|Part I: TDV 12 to 20 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214727|NCT01511250|O2|Outcome|Part I: Placebo 21 to 45 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
214728|NCT01511250|O1|Outcome|Part I: TDV 21 to 45 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214729|NCT01511250|O10|Outcome|Part II: Placebo 1.5 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214730|NCT01511250|O9|Outcome|Part II: TDV 1.5 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214731|NCT01511250|O8|Outcome|Part I: Placebo 1.5 to 5 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214732|NCT01511250|O7|Outcome|Part I: TDV 1.5 to 5 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214733|NCT01511250|O6|Outcome|Part I: Placebo 6 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
214734|NCT01511250|O5|Outcome|Part I: TDV 6 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214735|NCT01511250|O4|Outcome|Part I: Placebo 12 to 20 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
214736|NCT01511250|O3|Outcome|Part I: TDV 12 to 20 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214737|NCT01511250|O2|Outcome|Part I: Placebo 21 to 45 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
214738|NCT01511250|O1|Outcome|Part I: TDV 21 to 45 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214739|NCT01511250|O10|Outcome|Part II: Placebo 1.5 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214740|NCT01511250|O9|Outcome|Part II: TDV 1.5 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214741|NCT01511250|O8|Outcome|Part I: Placebo 1.5 to 5 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214742|NCT01511250|O7|Outcome|Part I: TDV 1.5 to 5 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214743|NCT01511250|O6|Outcome|Part I: Placebo 6 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
214744|NCT01511250|O5|Outcome|Part I: TDV 6 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214745|NCT01511250|O4|Outcome|Part I: Placebo 12 to 20 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
214746|NCT01511250|O3|Outcome|Part I: TDV 12 to 20 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214747|NCT01511250|O2|Outcome|Part I: Placebo 21 to 45 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
215654|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
214748|NCT01511250|O1|Outcome|Part I: TDV 21 to 45 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214749|NCT01511250|O10|Outcome|Part II: Placebo 1.5 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214750|NCT01511250|O9|Outcome|Part II: TDV 1.5 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214751|NCT01511250|O8|Outcome|Part I: Placebo 1.5 to 5 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214752|NCT01511250|O7|Outcome|Part I: TDV 1.5 to 5 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214753|NCT01511250|O6|Outcome|Part I: Placebo 6 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
214754|NCT01511250|O5|Outcome|Part I: TDV 6 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214755|NCT01511250|O4|Outcome|Part I: Placebo 12 to 20 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
214756|NCT01511250|O3|Outcome|Part I: TDV 12 to 20 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214757|NCT01511250|O2|Outcome|Part I: Placebo 21 to 45 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
214758|NCT01511250|O1|Outcome|Part I: TDV 21 to 45 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214759|NCT01511250|O10|Outcome|Part II: Placebo 1.5 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214760|NCT01511250|O9|Outcome|Part II: TDV 1.5 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214761|NCT01511250|O8|Outcome|Part I: Placebo 1.5 to 5 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214762|NCT01511250|O7|Outcome|Part I: TDV 1.5 to 5 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214763|NCT01511250|O6|Outcome|Part I: Placebo 6 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
214764|NCT01511250|O5|Outcome|Part I: TDV 6 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214765|NCT01511250|O4|Outcome|Part I: Placebo 12 to 20 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
214766|NCT01511250|O3|Outcome|Part I: TDV 12 to 20 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214767|NCT01511250|O2|Outcome|Part I: Placebo 21 to 45 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
214768|NCT01511250|O1|Outcome|Part I: TDV 21 to 45 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214769|NCT01511250|E10|Reported Event|Part II: Placebo 1.5 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214770|NCT01511250|E9|Reported Event|Part II: TDV 1.5 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214771|NCT01511250|E8|Reported Event|Part I: Placebo 1.5 to 5 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
214772|NCT01511250|E7|Reported Event|Part I: TDV 1.5 to 5 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214773|NCT01511250|E6|Reported Event|Part I: Placebo 6 to 11 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
214774|NCT01511250|E5|Reported Event|Part I: TDV 6 to 11 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214775|NCT01511250|E4|Reported Event|Part I: Placebo 12 to 20 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
214776|NCT01511250|E3|Reported Event|Part I: TDV 12 to 20 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214777|NCT01511250|E2|Reported Event|Part I: Placebo 21 to 45 Years|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
214778|NCT01511250|E1|Reported Event|Part I: TDV 21 to 45 Years|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
214779|NCT01511107|B3|Baseline|Total|Total of all reporting groups
214780|NCT01511107|B2|Baseline|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
214781|NCT01511107|B1|Baseline|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
214782|NCT01511107|P2|Participant Flow|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
214783|NCT01511107|P1|Participant Flow|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
214784|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
214785|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
214786|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
214787|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
214788|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
214789|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
214790|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
214791|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
214792|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
214793|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
214794|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
214795|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
214796|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
214797|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
214798|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
214799|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
214800|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
214801|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
214802|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
214803|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
214804|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
214806|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
214807|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
214808|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
214809|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
214810|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
214811|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
214812|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
214813|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
214814|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
214815|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
214816|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
214817|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
214818|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
214819|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
214820|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
214821|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
214822|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
214823|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
214824|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
214825|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
214826|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
214827|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
214828|NCT01511107|E2|Reported Event|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
214829|NCT01511107|E1|Reported Event|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
214830|NCT01511081|B3|Baseline|Total|Total of all reporting groups
214831|NCT01511081|B2|Baseline|SBPT (Stereotactic Body Proton Therapy)|50 Gy (RBE) in 4 daily treatments of stereotactic body proton therapy (SBPT). Each treatment taking about 30-45 minutes per day.
214832|NCT01511081|B1|Baseline|SBRT (Stereotactic Body Radiotherapy)|50 Gy (RBE) in 4 daily treatments of stereotactic body radiotherapy (SBRT). Each treatment taking about 30-45 minutes per day.
214833|NCT01511081|P2|Participant Flow|SBPT (Stereotactic Body Proton Therapy)|50 Gy (RBE) in 4 daily treatments of stereotactic body proton therapy (SBPT). Each treatment taking about 30-45 minutes per day.
214834|NCT01511081|P1|Participant Flow|SBRT (Stereotactic Body Radiotherapy)|50 Gy (RBE) in 4 daily treatments of stereotactic body radiotherapy (SBRT). Each treatment taking about 30-45 minutes per day.
214835|NCT01511081|O2|Outcome|SBPT (Stereotactic Body Proton Therapy)|50 Gy (RBE) in 4 daily treatments of stereotactic body proton therapy (SBPT). Each treatment taking about 30-45 minutes per day.
214836|NCT01511081|O1|Outcome|SBRT (Stereotactic Body Radiotherapy)|50 Gy (RBE) in 4 daily treatments of stereotactic body radiotherapy (SBRT). Each treatment taking about 30-45 minutes per day.
214837|NCT01511081|O2|Outcome|SBPT (Stereotactic Body Proton Therapy)|50 Gy (RBE) in 4 daily treatments of stereotactic body proton therapy (SBPT). Each treatment taking about 30-45 minutes per day.
214838|NCT01511081|O1|Outcome|SBRT (Stereotactic Body Radiotherapy)|50 Gy (RBE) in 4 daily treatments of stereotactic body radiotherapy (SBRT). Each treatment taking about 30-45 minutes per day.
214839|NCT01511081|E2|Reported Event|SBPT (Stereotactic Body Proton Therapy)|50 Gy (RBE) in 4 daily treatments of stereotactic body proton therapy (SBPT). Each treatment taking about 30-45 minutes per day.
214840|NCT01511081|E1|Reported Event|SBRT (Stereotactic Body Radiotherapy)|50 Gy (RBE) in 4 daily treatments of stereotactic body radiotherapy (SBRT). Each treatment taking about 30-45 minutes per day.
214841|NCT01511016|B3|Baseline|Total|Total of all reporting groups
214949|NCT01510652|P1|Participant Flow|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet~Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
215655|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
214842|NCT01511016|B2|Baseline|Human Recombinant Leptin (Metreleptin)|"Each subject will receive 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin will be administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
214843|NCT01511016|B1|Baseline|Placebo Injection|"Each subject will receive placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo will administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
214844|NCT01511016|P2|Participant Flow|Human Recombinant Leptin (Metreleptin)|"Each subject will receive 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin will be administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
214845|NCT01511016|P1|Participant Flow|Placebo Injection|"Each subject will receive placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo will administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
214846|NCT01511016|O2|Outcome|Human Recombinant Leptin (Metreleptin)|"Each subject received 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
214847|NCT01511016|O1|Outcome|Placebo Injection|"Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
214848|NCT01511016|O2|Outcome|Human Recombinant Leptin (Metreleptin)|"Each subject received 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
214849|NCT01511016|O1|Outcome|Placebo Injection|"Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
214850|NCT01511016|O2|Outcome|Human Recombinant Leptin (Metreleptin)|"Each subject received 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
214851|NCT01511016|O1|Outcome|Placebo Injection|"Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
214852|NCT01511016|O2|Outcome|Human Recombinant Leptin (Metreleptin)|"Each subject received 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
214853|NCT01511016|O1|Outcome|Placebo Injection|"Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
214854|NCT01511016|O2|Outcome|Human Recombinant Leptin (Metreleptin)|"Each subject will receive 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin will be administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
214855|NCT01511016|O1|Outcome|Placebo Injection|"Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
214856|NCT01511016|O2|Outcome|Human Recombinant Leptin (Metreleptin)|"Each subject received 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
214857|NCT01511016|O1|Outcome|Placebo Injection|"Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
214858|NCT01511016|E2|Reported Event|Human Recombinant Leptin (Metreleptin)|"Each subject will receive 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin will be administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
214859|NCT01511016|E1|Reported Event|Placebo Injection|"Each subject will receive placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo will administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
214950|NCT01510652|O2|Outcome|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)~Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
214860|NCT01510912|B1|Baseline|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
214861|NCT01510912|P1|Participant Flow|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
214862|NCT01510912|O1|Outcome|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
214863|NCT01510912|O1|Outcome|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
214864|NCT01510912|O1|Outcome|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
214865|NCT01510912|E1|Reported Event|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
214866|NCT01510834|B1|Baseline|All Participants|All participants who met study criteria, consented and were enrolled, were asked to complete online assessments at three timepoints(baseline, 1-month, and 3-months) and complete 2 or more behavioral programs each month.
214867|NCT01510834|P1|Participant Flow|All Participants|All participants who met study criteria, consented and were enrolled, were asked to complete online assessments at three timepoints(baseline, 1-month, and 3-months) and complete 2 or more behavioral programs each month.
214868|NCT01510834|O1|Outcome|Mean Difference in PHQ-8 (T1, T3)|Mean Difference in PHQ-8 (T1,T3) for study completers
214869|NCT01510834|O1|Outcome|Mean Difference in PSS (T1, T3)|Mean difference in Perceived Stress Scale (T1, T3) for study completers
214870|NCT01510834|O1|Outcome|Mean Difference in QOLS (T1, T3)|Mean Difference in QOLS (T1, T3)for study completers only
214871|NCT01510834|O1|Outcome|Mean Difference in PCL (T1, T3) (Negative Change is Better)|Mean difference in PCL (T1, T3) for study completers
214872|NCT01510834|E1|Reported Event|All Participants|All participants who met study criteria, consented and were enrolled, were asked to complete online assessments at three timepoints(baseline, 1-month, and 3-months) and complete 2 or more behavioral programs each month.
214873|NCT01510769|B4|Baseline|Total|Total of all reporting groups
214874|NCT01510769|B3|Baseline|Placebo + Febuxostat|
214875|NCT01510769|B2|Baseline|Lesinurad 400 mg + Febuxostat|
214876|NCT01510769|B1|Baseline|Lesinurad 200 mg + Febuxostat|
214877|NCT01510769|P3|Participant Flow|Placebo + Febuxostat|
214878|NCT01510769|P2|Participant Flow|Lesinurad 400 mg + Febuxostat|
214879|NCT01510769|P1|Participant Flow|Lesinurad 200 mg + Febuxostat|
214880|NCT01510769|O3|Outcome|Placebo + Febuxostat 80 mg|placebo qd plus febuxostat 80 mg
214881|NCT01510769|O2|Outcome|Lesinurad 400 mg + Febuxostat 80 mg|lesinurad 400 mg qd plus febuxostat 80 mg
214882|NCT01510769|O1|Outcome|Lesinurad 200 mg + Febuxostat 80 mg|lesinurad 200 mg once daily (qd) plus febuxostat 80 mg
214883|NCT01510769|O3|Outcome|Placebo + Febuxostat 80 mg|placebo qd plus febuxostat 80 mg
214884|NCT01510769|O2|Outcome|Lesinurad 400 mg + Febuxostat 80 mg|lesinurad 400 mg qd plus febuxostat 80 mg
214885|NCT01510769|O1|Outcome|Lesinurad 200 mg + Febuxostat 80 mg|lesinurad 200 mg once daily (qd) plus febuxostat 80 mg
214886|NCT01510769|O3|Outcome|Placebo + Febuxostat 80 mg|placebo qd plus febuxostat 80 mg
214887|NCT01510769|O2|Outcome|Lesinurad 400 mg + Febuxostat 80 mg|lesinurad 400 mg qd plus febuxostat 80 mg
214888|NCT01510769|O1|Outcome|Lesinurad 200 mg + Febuxostat 80 mg|lesinurad 200 mg once daily (qd) plus febuxostat 80 mg
214889|NCT01510769|O3|Outcome|Placebo + Febuxostat 80 mg|placebo qd plus febuxostat 80 mg
214890|NCT01510769|O2|Outcome|Lesinurad 400 mg + Febuxostat 80 mg|lesinurad 400 mg qd plus febuxostat 80 mg
214891|NCT01510769|O1|Outcome|Lesinurad 200 mg + Febuxostat 80 mg|lesinurad 200 mg once daily (qd) plus febuxostat 80 mg
214892|NCT01510769|E3|Reported Event|Placebo + Febuxostat|
214893|NCT01510769|E2|Reported Event|Lesinurad 400 mg + Febuxostat|
214894|NCT01510769|E1|Reported Event|Lesinurad 200 mg + Febuxostat|
214895|NCT01510756|B1|Baseline|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).~Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
214896|NCT01510756|P1|Participant Flow|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).~Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
215267|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
214897|NCT01510756|O1|Outcome|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).~Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
214898|NCT01510756|O1|Outcome|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).~Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
214899|NCT01510756|O1|Outcome|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).~Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
214900|NCT01510756|E1|Reported Event|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).~Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
214901|NCT01510717|B3|Baseline|Total|Total of all reporting groups
214902|NCT01510717|B2|Baseline|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
214903|NCT01510717|B1|Baseline|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
214904|NCT01510717|P2|Participant Flow|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
214905|NCT01510717|P1|Participant Flow|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
214906|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
214907|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
214908|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
214909|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
214910|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
214911|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
214912|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
214913|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
214914|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
214915|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
214916|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
214917|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
214918|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
214919|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
214920|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
214921|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
214922|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
214923|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
214924|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
214925|NCT01510717|E3|Reported Event|Monofocal IOL|All participants with attempted IOL implantation in at least one eye (successful or aborted after contact with the eye), AcrySof® IQ Monofocal IOL Model SN60WF
214926|NCT01510717|E2|Reported Event|Multifocal IOL|All participants with attempted IOL implantation in at least one eye (successful or aborted after contact with the eye), AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
214927|NCT01510717|E1|Reported Event|Pre-Treatment|All enrolled participants
214928|NCT01510704|B5|Baseline|Total|Total of all reporting groups
214929|NCT01510704|B4|Baseline|High Dose APD421|20mg dose level
214930|NCT01510704|B3|Baseline|Mid Dose APD421|5mg dose level
214931|NCT01510704|B2|Baseline|Low Dose APD421|1mg dose level
214932|NCT01510704|B1|Baseline|Placebo|
214933|NCT01510704|P4|Participant Flow|High Dose APD421|20mg dose level
214934|NCT01510704|P3|Participant Flow|Mid Dose APD421|5mg dose level
214935|NCT01510704|P2|Participant Flow|Low Dose APD421|1mg dose level
214936|NCT01510704|P1|Participant Flow|Placebo|
214937|NCT01510704|O4|Outcome|High Dose APD421|20mg dose level
214938|NCT01510704|O3|Outcome|Mid Dose APD421|5mg dose level
214939|NCT01510704|O2|Outcome|Low Dose APD421|1mg dose level
214940|NCT01510704|O1|Outcome|Placebo|
214941|NCT01510704|E4|Reported Event|High Dose APD421|20mg dose level
214942|NCT01510704|E3|Reported Event|Mid Dose APD421|5mg dose level
214943|NCT01510704|E2|Reported Event|Low Dose APD421|1mg dose level
214944|NCT01510704|E1|Reported Event|Placebo|
214945|NCT01510652|B3|Baseline|Total|Total of all reporting groups
214946|NCT01510652|B2|Baseline|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)~Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
214947|NCT01510652|B1|Baseline|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet~Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
214948|NCT01510652|P2|Participant Flow|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)~Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
215040|NCT01510145|B1|Baseline|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
214951|NCT01510652|O1|Outcome|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet~Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
214952|NCT01510652|O2|Outcome|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)~Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
214953|NCT01510652|O1|Outcome|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet~Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
214954|NCT01510652|O2|Outcome|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)~Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
214955|NCT01510652|O1|Outcome|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet~Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
214956|NCT01510652|E2|Reported Event|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)~Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
214957|NCT01510652|E1|Reported Event|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet~Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
214958|NCT01510457|B3|Baseline|Total|Total of all reporting groups
214959|NCT01510457|B2|Baseline|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
214960|NCT01510457|B1|Baseline|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
214961|NCT01510457|P2|Participant Flow|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
214962|NCT01510457|P1|Participant Flow|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
214963|NCT01510457|O2|Outcome|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
214964|NCT01510457|O1|Outcome|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
214965|NCT01510457|O2|Outcome|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
214966|NCT01510457|O1|Outcome|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
214967|NCT01510457|O2|Outcome|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
214968|NCT01510457|O1|Outcome|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
214969|NCT01510457|O2|Outcome|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
214970|NCT01510457|O1|Outcome|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
214999|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
214971|NCT01510457|O2|Outcome|Milnacipran|"Uptitration from 10mg to 50mg BID Milnacipran~Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used."
214972|NCT01510457|O1|Outcome|Sugar Pill|"BID placebo~Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication."
214973|NCT01510457|O2|Outcome|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
214974|NCT01510457|O1|Outcome|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
214975|NCT01510457|O2|Outcome|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
214976|NCT01510457|O1|Outcome|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
214977|NCT01510457|E2|Reported Event|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
214978|NCT01510457|E1|Reported Event|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
214979|NCT01510379|B3|Baseline|Total|Total of all reporting groups
214980|NCT01510379|B2|Baseline|Control|Scheduled ondansetron plus phenergan prn
214981|NCT01510379|B1|Baseline|Reletex|Reletex plus scheduled ondansetron and phenergan prn
214982|NCT01510379|P2|Participant Flow|Control|Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
214983|NCT01510379|P1|Participant Flow|Reletex|Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
214984|NCT01510379|O2|Outcome|Control|Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
214985|NCT01510379|O1|Outcome|Reletex|Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
214986|NCT01510379|O2|Outcome|Control|Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
214987|NCT01510379|O1|Outcome|Reletex|Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
214988|NCT01510379|E2|Reported Event|Control|Scheduled ondansetron plus phenergan prn
214989|NCT01510379|E1|Reported Event|Reletex|Reletex plus scheduled ondansetron and phenergan prn
214990|NCT01510327|B1|Baseline|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
214991|NCT01510327|P1|Participant Flow|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
214992|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
214993|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
214994|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
214995|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
214996|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
214997|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
214998|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
215000|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
215001|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
215002|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
215003|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
215004|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
215005|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
215006|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
215007|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
215008|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
215009|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
215010|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
215011|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
215012|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
215013|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
215014|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
215015|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
215016|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
215017|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.
215018|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.
215019|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents
215020|NCT01510327|E1|Reported Event|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
215021|NCT01510158|B4|Baseline|Total|Total of all reporting groups
215022|NCT01510158|B3|Baseline|Placebo + Allopurinol|placebo qd plus allopurinol
215023|NCT01510158|B2|Baseline|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
215024|NCT01510158|B1|Baseline|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
215025|NCT01510158|P3|Participant Flow|Placebo + Allopurinol|placebo qd plus allopurinol
215026|NCT01510158|P2|Participant Flow|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
215027|NCT01510158|P1|Participant Flow|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
215028|NCT01510158|O3|Outcome|Placebo + Allopurinol|placebo qd plus allopurinol
215029|NCT01510158|O2|Outcome|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
215030|NCT01510158|O1|Outcome|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
215031|NCT01510158|O3|Outcome|Placebo + Allopurinol|placebo qd plus allopurinol
215032|NCT01510158|O2|Outcome|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
215041|NCT01510145|P1|Participant Flow|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
215042|NCT01510145|O1|Outcome|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
215043|NCT01510145|O1|Outcome|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
215044|NCT01510145|E1|Reported Event|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
215045|NCT01509807|B3|Baseline|Total|Total of all reporting groups
215046|NCT01509807|B2|Baseline|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
215047|NCT01509807|B1|Baseline|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
215048|NCT01509807|P2|Participant Flow|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
215049|NCT01509807|P1|Participant Flow|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
215050|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
215051|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
215052|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
215053|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
215054|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
215055|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
215056|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
215057|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
215058|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
215059|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
215060|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
215061|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
215062|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
215063|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
215064|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
215065|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
215066|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
215067|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
215068|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
215069|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
215070|NCT01509807|E2|Reported Event|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
215071|NCT01509807|E1|Reported Event|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
215072|NCT01509664|B3|Baseline|Total|Total of all reporting groups
215073|NCT01509664|B2|Baseline|Control|Received no discount at the participating supermarket.
215074|NCT01509664|B1|Baseline|Discount Intervention|"Receives 50% discount intervention on selected fruits and vegetables at participating supermarket.~Discount intervention: 50% discount on selected fruits and vegetables at participating supermarket"
215075|NCT01509664|P2|Participant Flow|Control|Received no discount at the participating supermarket.
215076|NCT01509664|P1|Participant Flow|Discount Intervention|"Receives 50% discount intervention on selected fruits and vegetables at participating supermarket.~Discount intervention: 50% discount on selected fruits and vegetables at participating supermarket"
215077|NCT01509664|O2|Outcome|Control|Received no discount at the participating supermarket.
215078|NCT01509664|O1|Outcome|Discount Intervention|"Receives 50% discount intervention on selected fruits and vegetables at participating supermarket.~Discount intervention: 50% discount on selected fruits and vegetables at participating supermarket"
215079|NCT01509664|E2|Reported Event|Control|Received no discount at the participating supermarket.
215080|NCT01509664|E1|Reported Event|Discount Intervention|"Receives 50% discount intervention on selected fruits and vegetables at participating supermarket.~Discount intervention: 50% discount on selected fruits and vegetables at participating supermarket"
215081|NCT01509638|B3|Baseline|Total|Total of all reporting groups
215082|NCT01509638|B2|Baseline|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
215083|NCT01509638|B1|Baseline|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
215084|NCT01509638|P2|Participant Flow|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
215085|NCT01509638|P1|Participant Flow|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
215268|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
215086|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
215087|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
215088|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
215089|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
215090|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
215091|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
215092|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
215093|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
215094|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
215095|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
215096|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
215097|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
215098|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
215099|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
215100|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
215101|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
215102|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
215103|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
215269|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
215270|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
215656|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
215104|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
215105|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
215106|NCT01509638|E2|Reported Event|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
215107|NCT01509638|E1|Reported Event|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
215108|NCT01509625|B1|Baseline|One Arm of Metastatic RE Breast Cancer Patients|Women with metastatic breast cancer who have disease progresion after prior antiestrogen treatment. All tumors were positive estrogen receptors
215109|NCT01509625|P1|Participant Flow|One Arm of Metastatic Breast Cancer Patients|All the patients have tumors with positive estrogen receptors
215110|NCT01509625|O2|Outcome|Patients With Tumors ki67 Negative|Patients with tumors with low ki67 expression
215111|NCT01509625|O1|Outcome|Patients With Tumors ki67 Positive|Patients with tumors with high ki67 expression
215112|NCT01509625|O2|Outcome|Patients With Tumors HER2 Negative|tumor is considered HER2 negative if there is not a sobreexpression of the receptor by immunohistochemistry or FISH is positive
215113|NCT01509625|O1|Outcome|Patients With Tumors HER2 Positive|tumor is considered HER2 positive if there is a sobreexpression of the receptor by immunohistochemistry or FISH is positive
215114|NCT01509625|O2|Outcome|Previous Treatment With Two or More Hormonal Treatment Lines|The patients have received at least two hormonal treatment: tamoxifen and aromatase inhibitor
215115|NCT01509625|O1|Outcome|Previous Treatment Wiht One Line of Hormonal Treatment|Hormonal treatment was tamoxifen or an aromatase inhibitor
215116|NCT01509625|O2|Outcome|Patients With Visceral Metastasis|Group of patients with metastasis in organs like liver or lungs
215117|NCT01509625|O1|Outcome|Patients Without Visceral Metastasis|Group of patients without metastasis in organs like liver or lungs
215118|NCT01509625|O1|Outcome|One Arm of Metastatic Breast Cancer Patients|All patients have tumors with positive estrogen receptors
215119|NCT01509625|O1|Outcome|Patients With Clinical Benefit|Patients wich achieved a clinical benefit with fulvetrant 500: complete response, partial response or stable disease of 24 weeks or longer
215120|NCT01509625|O1|Outcome|One Arm of Metastatic Breast Cancer Patients|All patients have tumors with positive estrogen receptors
215121|NCT01509625|O1|Outcome|One Arm of Metastatic Breast Cancer Patients|All patients have tumors with positive estrogen receptors
215122|NCT01509625|O1|Outcome|One Arm of Metastatic Breast Cancer Patients|All patients have tumors with positive estrogen receptors
215123|NCT01509625|E1|Reported Event|One Arm of Metastatic Breast Cancer Patients|All patients have tumors with positive estrogen receptors
215124|NCT01509586|B3|Baseline|Total|Total of all reporting groups
215125|NCT01509586|B2|Baseline|Cigarette Group|This group will smoke their normal cigarettes as much or as little as they want to.
215126|NCT01509586|B1|Baseline|PREP (Potentially Reduced Exposure Product) Group|Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
215127|NCT01509586|P2|Participant Flow|Cigarette Group|This group will smoke their normal cigarettes as much or as little as they want to.
215128|NCT01509586|P1|Participant Flow|PREP (Potentially Reduced Exposure Product) Group|Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
215129|NCT01509586|O2|Outcome|Cigarette Group|This group will smoke their normal cigarettes as much or as little as they want to.
215130|NCT01509586|O1|Outcome|PREP (Potentially Reduced Exposure Product) Group|Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
215131|NCT01509586|E2|Reported Event|Cigarette Group|This group will smoke their normal cigarettes as much or as little as they want to.
215271|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
215272|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
215132|NCT01509586|E1|Reported Event|PREP (Potentially Reduced Exposure Product) Group|Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
215133|NCT01509183|B3|Baseline|Total|Total of all reporting groups
215134|NCT01509183|B2|Baseline|Control Group|Control group (CG) participants were outfitted with sensors from the Propeller Health System, but did not receive feedback.
215135|NCT01509183|B1|Baseline|Intervention Group|"Intervention group (IG) participants received access to and feedback from the Propeller Health System (formerly Asthmapolis System).~Propeller Health System (formerly Asthmapolis System): The Propeller (formerly Asthmapolis) system works through the provision of information to patients and their providers. With the Propeller (formerly Asthmapolis) device in place, each actuation of a patient's rescue inhaler is recorded with an automatic time stamp; in many circumstances, the location at which the device is actuated is also captured and recorded. Actuation data are then securely transmitted to Propeller (formerly Asthmapolis) where events and an assessment of asthma control can be viewed in secure online interfaces. The information is also compiled into individual reports that are returned to the patient and his or her provider. Patients also receive customized suggestions for asthma management based on their actuation history."
215136|NCT01509183|P2|Participant Flow|Control Group|Control group (CG) participants were outfitted with sensors from the Propeller Health System, but did not receive feedback.
215137|NCT01509183|P1|Participant Flow|Intervention Group|"Intervention group (IG) participants received access to and feedback from the Propeller Health System (formerly Asthmapolis System).~Propeller Health System (formerly Asthmapolis System): The Propeller (formerly Asthmapolis) system works through the provision of information to patients and their providers. With the Propeller (formerly Asthmapolis) device in place, each actuation of a patient's rescue inhaler is recorded with an automatic time stamp; in many circumstances, the location at which the device is actuated is also captured and recorded. Actuation data are then securely transmitted to Propeller (formerly Asthmapolis) where events and an assessment of asthma control can be viewed in secure online interfaces. The information is also compiled into individual reports that are returned to the patient and his or her provider. Patients also receive customized suggestions for asthma management based on their actuation history."
215138|NCT01509183|O2|Outcome|Control Group|Control group (CG) participants were outfitted with sensors from the Propeller Health System, but did not receive feedback.
215139|NCT01509183|O1|Outcome|Intervention Group|"Intervention group (IG) participants received access to and feedback from the Propeller Health System (formerly Asthmapolis System).~Propeller Health System (formerly Asthmapolis System): The Propeller (formerly Asthmapolis) system works through the provision of information to patients and their providers. With the Propeller (formerly Asthmapolis) device in place, each actuation of a patient's rescue inhaler is recorded with an automatic time stamp; in many circumstances, the location at which the device is actuated is also captured and recorded. Actuation data are then securely transmitted to Propeller (formerly Asthmapolis) where events and an assessment of asthma control can be viewed in secure online interfaces. The information is also compiled into individual reports that are returned to the patient and his or her provider. Patients also receive customized suggestions for asthma management based on their actuation history."
215140|NCT01509183|O2|Outcome|Control Group|Control group (CG) participants were outfitted with sensors from the Propeller Health System, but did not receive feedback.
215141|NCT01509183|O1|Outcome|Intervention Group|"Intervention group (IG) participants received access to and feedback from the Propeller Health System (formerly Asthmapolis System).~Propeller Health System (formerly Asthmapolis System): The Propeller (formerly Asthmapolis) system works through the provision of information to patients and their providers. With the Propeller (formerly Asthmapolis) device in place, each actuation of a patient's rescue inhaler is recorded with an automatic time stamp; in many circumstances, the location at which the device is actuated is also captured and recorded. Actuation data are then securely transmitted to Propeller (formerly Asthmapolis) where events and an assessment of asthma control can be viewed in secure online interfaces. The information is also compiled into individual reports that are returned to the patient and his or her provider. Patients also receive customized suggestions for asthma management based on their actuation history."
215142|NCT01509183|E2|Reported Event|Control Group|Control group (CG) participants were outfitted with sensors from the Propeller Health System, but did not receive feedback.
215143|NCT01509183|E1|Reported Event|Intervention Group|"Intervention group (IG) participants received access to and feedback from the Propeller Health System (formerly Asthmapolis System).~Propeller Health System (formerly Asthmapolis System): The Propeller (formerly Asthmapolis) system works through the provision of information to patients and their providers. With the Propeller (formerly Asthmapolis) device in place, each actuation of a patient's rescue inhaler is recorded with an automatic time stamp; in many circumstances, the location at which the device is actuated is also captured and recorded. Actuation data are then securely transmitted to Propeller (formerly Asthmapolis) where events and an assessment of asthma control can be viewed in secure online interfaces. The information is also compiled into individual reports that are returned to the patient and his or her provider. Patients also receive customized suggestions for asthma management based on their actuation history."
215144|NCT01509105|B1|Baseline|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
215273|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
215145|NCT01509105|P1|Participant Flow|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
215146|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
215147|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
215148|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
215149|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
215150|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
215151|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
215152|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
215153|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
215274|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
215275|NCT01508936|E2|Reported Event|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
215276|NCT01508936|E1|Reported Event|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
215154|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
215155|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
215156|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
215157|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
215158|NCT01509105|E1|Reported Event|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
215159|NCT01509079|B3|Baseline|Total|Total of all reporting groups
215160|NCT01509079|B2|Baseline|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
215161|NCT01509079|B1|Baseline|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
215162|NCT01509079|P2|Participant Flow|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
215163|NCT01509079|P1|Participant Flow|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
215164|NCT01509079|O2|Outcome|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
215165|NCT01509079|O1|Outcome|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
215166|NCT01509079|O2|Outcome|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
215167|NCT01509079|O1|Outcome|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
215168|NCT01509079|O2|Outcome|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
215169|NCT01509079|O1|Outcome|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
215170|NCT01509079|O2|Outcome|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
215171|NCT01509079|O1|Outcome|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
215172|NCT01509079|O2|Outcome|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
215173|NCT01509079|O1|Outcome|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
215174|NCT01509079|O2|Outcome|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
215175|NCT01509079|O1|Outcome|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
215176|NCT01509079|E2|Reported Event|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
215177|NCT01509079|E1|Reported Event|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
215178|NCT01509053|B1|Baseline|All Participants|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase (C). Oral aripiprazole was available as rescue medication if necessary.
215277|NCT01508910|B4|Baseline|Total|Total of all reporting groups
215278|NCT01508910|B3|Baseline|Unblinded Standard of Care (SOC) Arm|No study-related procedures will be performed.
215179|NCT01509053|P1|Participant Flow|Oral Aripiprazole Tablets and Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase (C). Oral aripiprazole was available as rescue medication if necessary.
215180|NCT01509053|O1|Outcome|Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
215181|NCT01509053|O1|Outcome|Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
215182|NCT01509053|O1|Outcome|Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
215183|NCT01509053|O1|Outcome|Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
215184|NCT01509053|O2|Outcome|Standard of Care|Patients who received oral antipsychotic treatment as standard of care in clinical practice.
215185|NCT01509053|O1|Outcome|Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
215186|NCT01509053|E3|Reported Event|Aripiprazole IM Depot (Phase C)|Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase (C). Oral aripiprazole was available as rescue medication if necessary.
215187|NCT01509053|E2|Reported Event|Aripiprazole IM Depot (Phase B)|In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
215188|NCT01509053|E1|Reported Event|Oral Aripiprazole (Phase A)|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot.
215189|NCT01509040|B4|Baseline|Total|Total of all reporting groups
215190|NCT01509040|B3|Baseline|High Volume Hemofiltration|"High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .~High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
215207|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
215657|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
215191|NCT01509040|B2|Baseline|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
215192|NCT01509040|B1|Baseline|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
215193|NCT01509040|P3|Participant Flow|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .~High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
215194|NCT01509040|P2|Participant Flow|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
215195|NCT01509040|P1|Participant Flow|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
215196|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
215197|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
215198|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
215253|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
215254|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
215255|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
215199|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
215200|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
215201|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
215202|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .~High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
215203|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
215204|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
215205|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
215206|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
215256|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
215257|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
215208|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
215209|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
215210|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
215211|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .~High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
215212|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
215213|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
215214|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
215215|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
215258|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
215259|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
215216|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
215217|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
215218|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
215219|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
215220|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
215221|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
215222|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
215223|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
215260|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
215261|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
215262|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
215263|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
215224|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
215225|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
215226|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
215227|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
215228|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
215229|NCT01509040|O3|Outcome|High Volume Hemofiltration|"Initiate standard post-resuscitative care including a triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. Fluids, 500-mL bolus of intravenous crystalloid given every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Standard Care: Triple-lumen central venous catheter inserted for pressure monitoring. All patients to receive 500-mL bolus of intravenous crystalloid every 30 minutes to achieve central venous pressure of 8 to 12 mm Hg; vasopressors if mean arterial pressure less than 65 mm Hg; and vasodilators if mean arterial pressure is 90 mm Hg or above.~Initiation and maintenance of therapeutic hypothermia, target core"
215230|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Fluids, 500-mL bolus of intravenous crystalloid given every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Standard Care: Triple-lumen central venous catheter inserted for pressure monitoring. All patients to receive 500-mL bolus of intravenous crystalloid every 30 minutes to achieve central venous pressure of 8 to 12 mm Hg; vasopressors if mean arterial pressure less than 65 mm Hg; and vasodilators if mean arterial pressure is 90 mm Hg or above.~Initiation and maintenance of therapeutic hypothermia, target core tem"
215231|NCT01509040|O1|Outcome|Control|"Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious. Fluids, 500-mL bolus of intravenous crystalloid given every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Standard Care: Triple-lumen central venous catheter inserted for pressure monitoring. All patients to receive 500-mL bolus of intravenous crystalloid every 30 minutes to achieve central venous pressure of 8 to 12 mm Hg; vasopressors if mean arterial pressure less than 65 mm Hg; and vasodilators if mean arterial pressure is 90 mm Hg or above.~Initiation and maintenance of therapeutic hypothermia, target core temperature of below 34°C via standard external cooling techniques.~Percutaneous coronary intervention performed as"
215264|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
215232|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .~High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
215233|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
215234|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
215235|NCT01509040|E3|Reported Event|High Volume Hemofiltration|"High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .~High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
215236|NCT01509040|E2|Reported Event|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
215237|NCT01509040|E1|Reported Event|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
215238|NCT01508936|B3|Baseline|Total|Total of all reporting groups
215239|NCT01508936|B2|Baseline|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
215240|NCT01508936|B1|Baseline|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
215241|NCT01508936|P2|Participant Flow|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
215242|NCT01508936|P1|Participant Flow|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
215243|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
215244|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
215245|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
215246|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
215247|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
215248|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
215249|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
215250|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
215251|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
215252|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
215279|NCT01508910|B2|Baseline|Active Control Arm|Targeted intramyocardial delivery of placebo after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
215280|NCT01508910|B1|Baseline|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
215281|NCT01508910|P4|Participant Flow|Not Injected Arm|Participants randomized into the Treatment Arm or Active Control Arm who did not undergo targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells or placebo, respectively.
215282|NCT01508910|P3|Participant Flow|Unblinded Standard of Care (SOC) Arm|No study-related procedures were performed.
215283|NCT01508910|P2|Participant Flow|Active Control Arm|Targeted intramyocardial delivery of placebo after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
215284|NCT01508910|P1|Participant Flow|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
215285|NCT01508910|O4|Outcome|Not Injected Arm|Participants randomized into the Treatment Arm or Active Control Arm who did not undergo targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells or placebo, respectively.
215286|NCT01508910|O3|Outcome|Unblinded Standard of Care (SOC) Arm|No study-related procedures will be performed.
215287|NCT01508910|O2|Outcome|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
215288|NCT01508910|O1|Outcome|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
215289|NCT01508910|O4|Outcome|Not Injected Arm|Participants randomized into the Treatment Arm or Active Control Arm who did not undergo targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells or placebo, respectively.
215290|NCT01508910|O3|Outcome|Unblinded Standard of Care (SOC) Arm|No study-related procedures will be performed.
215291|NCT01508910|O2|Outcome|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis.
215292|NCT01508910|O1|Outcome|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
215293|NCT01508910|O2|Outcome|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
215294|NCT01508910|O1|Outcome|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
215295|NCT01508910|O2|Outcome|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
215296|NCT01508910|O1|Outcome|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
215297|NCT01508910|O2|Outcome|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
215298|NCT01508910|O1|Outcome|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
215299|NCT01508910|O2|Outcome|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
215300|NCT01508910|O1|Outcome|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
215301|NCT01508910|E4|Reported Event|Not Treated Arm|Participants randomized into the Treatment Arm or Active Control Arm who did not undergo targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells or placebo, respectively.
215302|NCT01508910|E3|Reported Event|Unblinded Standard of Care (SOC) Arm|No study-related procedures will be performed.
215303|NCT01508910|E2|Reported Event|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
215304|NCT01508910|E1|Reported Event|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
215305|NCT01508832|B3|Baseline|Total|Total of all reporting groups
215306|NCT01508832|B2|Baseline|Lidocaine Block, Left Finger; Bupivacaine Block, Right Finger|Lidocaine 1% Digital Block (2cc), left finger; Bupivacaine 0.25% Digital Block (2 cc), right finger.
215307|NCT01508832|B1|Baseline|Lidocaine Block, Right Finger; Bupivacaine Block, Left Finger|Lidocaine 1% Digital Nerve Block (2 cc) , right finger. Bupivacaine 0.25% Digital Nerve Block (2 cc), left finger
215308|NCT01508832|P2|Participant Flow|Lidocaine Block, Left Finger; Bupivacaine Block, Right Finger|Lidocaine 1% digital nerve block (2cc), left finger; Bupivacaine 0.25% digital nerve block (2cc), right finger.
215309|NCT01508832|P1|Participant Flow|Lidocaine Block, Right Finger; Bupivacaine Block, Left Finger|Lidocaine 1% digital nerve block (2cc), right finger; Bupivacaine 0.25% digital nerve block (2cc), left finger.
215310|NCT01508832|O2|Outcome|Bupivacaine|Bupivacaine 0.25% digital nerve block (2cc) in one finger
215311|NCT01508832|O1|Outcome|Lidocaine|Lidocaine 1% digital nerve block (2cc) in one finger
215312|NCT01508832|E2|Reported Event|Bupivacaine|Bupivacaine digital block right or left finger
215313|NCT01508832|E1|Reported Event|Lidocaine|Lidocaine digital block in right or left finger
215314|NCT01508702|B3|Baseline|Total|Total of all reporting groups
215315|NCT01508702|B2|Baseline|Placebo|
215316|NCT01508702|B1|Baseline|Lesinurad 400 mg|lesinurad 400 mg
215317|NCT01508702|P2|Participant Flow|Placebo|
215318|NCT01508702|P1|Participant Flow|Lesinurad 400 mg|lesinurad 400 mg
215319|NCT01508702|O2|Outcome|Placebo|Placebo qd
215320|NCT01508702|O1|Outcome|Lesinurad 400 mg|lesinurad 400 mg
215321|NCT01508702|E2|Reported Event|Placebo|
215322|NCT01508702|E1|Reported Event|Lesinurad 400 mg|lesinurad 400 mg
215323|NCT01508676|B3|Baseline|Total|Total of all reporting groups
215324|NCT01508676|B2|Baseline|Placebo Phase I|Placebo lotion (20-40 drops; 2-4 times daily). Upon completion of the first phase, subjects in each arm will be crossed over (i.e., from placebo to Pennsaid and vise versa). Pennsaid or placebo lotion will be packed in a container with identical appearance before being dispensed to study subjects.
215505|NCT01507831|B1|Baseline|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215325|NCT01508676|B1|Baseline|Pennsaid Phase I|Pennsaid (20-40 drops; 2-4 times daily). Upon completion of the first phase, subjects in each arm will be crossed over (i.e., from placebo to Pennsaid and vise versa). Pennsaid or placebo lotion will be packed in a container with identical appearance before being dispensed to study subjects.
215326|NCT01508676|P2|Participant Flow|Placebo Phase I, Pennsaid Phase II|"Phase I: 2 weeks applying Placebo lotion (20-40 drops; 2-4 times daily).~Washout: 1 week, applying nothing.~Phase II: 2 weeks applying Pennsaid lotion (20-40 drops; 2-4 times daily)."
215327|NCT01508676|P1|Participant Flow|Pennsaid Phase I, Placebo Phase II|"Phase I: 2 weeks applying Pennsaid lotion (20-40 drops; 2-4 times daily).~Washout: 1 week, applying nothing.~Phase II: 2 weeks applying Placebo lotion (20-40 drops; 2-4 times daily)."
215328|NCT01508676|O2|Outcome|Placebo|All subjects who recieved Placebo lotion in either Phase I or II were considered.
215329|NCT01508676|O1|Outcome|Pennsaid|All subjects who recieved Pennsaid lotion in either Phase I or II were considered.
215330|NCT01508676|O2|Outcome|Placebo|All subjects who recieved Placebo lotion in either Phase I or II were considered.
215331|NCT01508676|O1|Outcome|Pennsaid|All subjects who recieved Pennsaid lotion in either Phase I or II were considered.
215332|NCT01508676|O2|Outcome|Placebo|All subjects who recieved Pennsaid lotion in either Phase I or II were considered.
215333|NCT01508676|O1|Outcome|Pennsaid|All subjects who recieved Pennsaid lotion in either Phase I or II were considered.
215334|NCT01508676|E2|Reported Event|Placebo|Placebo lotion (20-40 drops; 2-4 times daily for 2 weeks).
215335|NCT01508676|E1|Reported Event|Pennsaid|Pennsaid (20-40 drops; 2-4 times daily for 2 weeks).
215336|NCT01508455|B1|Baseline|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
215337|NCT01508455|P1|Participant Flow|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
215338|NCT01508455|O1|Outcome|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
215339|NCT01508455|O1|Outcome|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
215340|NCT01508455|O1|Outcome|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
215341|NCT01508455|O1|Outcome|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
215342|NCT01508455|O1|Outcome|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
215343|NCT01508455|O1|Outcome|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
215344|NCT01508455|E1|Reported Event|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
215345|NCT01508325|B3|Baseline|Total|Total of all reporting groups
215346|NCT01508325|B2|Baseline|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215347|NCT01508325|B1|Baseline|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215348|NCT01508325|P2|Participant Flow|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215349|NCT01508325|P1|Participant Flow|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 milligram (mg) once daily orally as sustained release (SR) tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic systolic blood pressure (SBP) was greater than or equal to (>=) 140 millimeters of mercury (mmHg) and/or diastolic blood pressure (DBP) was >=90 mmHg measured every 4 weeks.
215350|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215351|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215352|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215353|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215354|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215355|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215356|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215357|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215358|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215359|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215360|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215361|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215362|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215363|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215364|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215365|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215366|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215367|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215368|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215369|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215370|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215371|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215372|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215373|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215374|NCT01508325|E2|Reported Event|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215375|NCT01508325|E1|Reported Event|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
215376|NCT01508169|B3|Baseline|Total|Total of all reporting groups
215377|NCT01508169|B2|Baseline|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
215378|NCT01508169|B1|Baseline|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol.Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
215379|NCT01508169|P2|Participant Flow|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
215380|NCT01508169|P1|Participant Flow|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol.Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
215381|NCT01508169|O2|Outcome|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five patients completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
215382|NCT01508169|O1|Outcome|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four patients completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
215383|NCT01508169|O2|Outcome|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
215384|NCT01508169|O1|Outcome|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol.Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
215385|NCT01508169|O2|Outcome|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five patients finished the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
215404|NCT01508130|O1|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
215506|NCT01507831|P2|Participant Flow|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215386|NCT01508169|O1|Outcome|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four patients finished the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
215387|NCT01508169|O2|Outcome|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects complited the protocolBalance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
215388|NCT01508169|O1|Outcome|Foot Orthosis|Fourty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
215389|NCT01508169|E2|Reported Event|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
215390|NCT01508169|E1|Reported Event|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol.Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
215391|NCT01508130|B3|Baseline|Total|Total of all reporting groups
215392|NCT01508130|B2|Baseline|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
215393|NCT01508130|B1|Baseline|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
215394|NCT01508130|P2|Participant Flow|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
215395|NCT01508130|P1|Participant Flow|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received PegIFN + RBV + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
215396|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
215397|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
215398|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
215399|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
215400|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
215401|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
215402|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
215403|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
215405|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
215406|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
215407|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
215408|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
215409|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
215410|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
215411|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
215412|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
215413|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
215414|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
215415|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
215416|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
215417|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
215418|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
215419|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
215420|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
215421|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
215422|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
215423|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
215424|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
215425|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
215507|NCT01507831|P1|Participant Flow|Placebo Q2W|Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable lipid modifying therapy (LMT) for 78 weeks.
215426|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
215427|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
215428|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
215429|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
215430|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
215431|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
215432|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
215433|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
215434|NCT01508130|E2|Reported Event|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
215435|NCT01508130|E1|Reported Event|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
215436|NCT01508117|B1|Baseline|Axitinib + Radiation Therapy|"Axitinib 5mg twice daily for 28 days followed by concurrent axitinib plus hypofractionated radiation therapy (45 Gy in 15 fractions) followed by maintenance axitinib 5mg twice daily until progression or unacceptable toxicity~Axitinib: 5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity~Radiation Therapy: 45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy"
215437|NCT01508117|P1|Participant Flow|Axitinib + Radiation Therapy|"Axitinib 5mg twice daily for 28 days followed by concurrent axitinib plus hypofractionated radiation therapy (45 Gy in 15 fractions) followed by maintenance axitinib 5mg twice daily until progression or unacceptable toxicity~Axitinib: 5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity~Radiation Therapy: 45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy"
215438|NCT01508117|O1|Outcome|Axitinib + Radiation Therapy|"Axitinib 5mg twice daily for 28 days followed by concurrent axitinib plus hypofractionated radiation therapy (45 Gy in 15 fractions) followed by maintenance axitinib 5mg twice daily until progression or unacceptable toxicity~Axitinib: 5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity~Radiation Therapy: 45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy"
215439|NCT01508117|E1|Reported Event|Axitinib + Radiation Therapy|"Axitinib 5mg twice daily for 28 days followed by concurrent axitinib plus hypofractionated radiation therapy (45 Gy in 15 fractions) followed by maintenance axitinib 5mg twice daily until progression or unacceptable toxicity~Axitinib: 5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity~Radiation Therapy: 45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy"
215440|NCT01508052|B3|Baseline|Total|Total of all reporting groups
215441|NCT01508052|B2|Baseline|Elastic Stockings|"Apply elastic stockings during the thyroidectomy~sequential compression device: applying sequential compression device during the surgery"
215442|NCT01508052|B1|Baseline|Sequential Compression Device|"Apply sequential compression device during the thyroidectomy~elastic stockings: applying elastic stockings during the surgery"
215443|NCT01508052|P2|Participant Flow|Elastic Stockings|"Apply elastic stockings during the thyroidectomy~sequential compression device: applying sequential compression device during the surgery"
215444|NCT01508052|P1|Participant Flow|Sequential Compression Device|"Apply sequential compression device during the thyroidectomy~elastic stockings: applying elastic stockings during the surgery"
215445|NCT01508052|O2|Outcome|Elastic Stockings|"Apply elastic stockings during the thyroidectomy~sequential compression device: applying sequential compression device during the surgery"
215446|NCT01508052|O1|Outcome|Sequential Compression Device|"Apply sequential compression device during the thyroidectomy~elastic stockings: applying elastic stockings during the surgery"
215447|NCT01508052|E2|Reported Event|Elastic Stockings|"Apply elastic stockings during the thyroidectomy~sequential compression device: applying sequential compression device during the surgery"
215448|NCT01508052|E1|Reported Event|Sequential Compression Device|"Apply sequential compression device during the thyroidectomy~elastic stockings: applying elastic stockings during the surgery"
215449|NCT01508013|B3|Baseline|Total|Total of all reporting groups
215450|NCT01508013|B2|Baseline|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
215451|NCT01508013|B1|Baseline|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
215452|NCT01508013|P2|Participant Flow|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
215453|NCT01508013|P1|Participant Flow|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
215454|NCT01508013|O2|Outcome|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
215455|NCT01508013|O1|Outcome|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
215456|NCT01508013|O2|Outcome|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
215457|NCT01508013|O1|Outcome|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
215458|NCT01508013|O2|Outcome|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
215459|NCT01508013|O1|Outcome|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
215460|NCT01508013|E2|Reported Event|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
215461|NCT01508013|E1|Reported Event|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
215462|NCT01507896|B1|Baseline|Treatment With BAX326|Recombinant Factor IX (FIX): Following a loading dose with BAX326, participants received BAX326 as a bolus infusion. The treatment regimen was determined by the intensity and duration of the hemostatic challenge and the institution's standard of care. The dose was tailored to raise FIX concentration to at least 80%-100% of normal for major surgeries and to at least 30%-60% of normal for minor surgeries. Note: Treatment with BAX326 refers to unique participants treated with BAX326 which is less than the number of participants treated with BAX326 as unique participants could undergo more than one surgical procedure in this study. 30 unique participants were treated with BAX326 for 40 planned surgical procedures; of these, 2 unique participants were treated with BAX326 but did not undergo 2 surgical procedures (1 surgery per unique participant), therefore 28 unique participants underwent 38 surgical procedures.
215463|NCT01507896|P1|Participant Flow|Treatment With BAX326|Recombinant Factor IX (FIX): Following a loading dose with BAX326, participants received BAX326 as a bolus infusion. The treatment regimen was determined by the intensity and duration of the hemostatic challenge and the institution's standard of care. The dose was tailored to raise FIX concentration to at least 80%-100% of normal for major surgeries and to at least 30%-60% of normal for minor surgeries. Note: Treatment with BAX326 refers to unique participants treated with BAX326 which is less than the number of participants treated with BAX326 as unique participants could undergo more than one surgical procedure in this study. 30 unique participants were treated with BAX326 for 40 planned surgical procedures; of these, 2 unique participants were treated with BAX326 but did not undergo 2 surgical procedures (1 surgery per unique participant), therefore 28 unique participants underwent 38 surgical procedures.
215464|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
215465|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
215466|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
215467|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
215501|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
215502|NCT01507896|E1|Reported Event|All Participants|All unique participants treated with BAX326 per planned surgical procedure.
215468|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
215469|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
215470|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
215471|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
215472|NCT01507896|O1|Outcome|Treatment With BAX326|All participants treated with BAX326 per planned surgical procedure and per unique participant. Data is reported as treatment with BAX326 per planned surgical procedure (including participants who discontinued in the study after treatment with BAX326 but before surgery was done) and per unique participants as a unique participant could be treated with BAX326 for more than one surgical procedure in this study.
215473|NCT01507896|O1|Outcome|Treatment With BAX326|All participants treated with BAX326 per planned surgical procedure and per unique participant. Data is reported as treatment with BAX326 per planned surgical procedure (including participants who discontinued in the study after treatment with BAX326 but before surgery was done) and per unique participants as a unique participant could be treated with BAX326 for more than one surgical procedure in this study.
215474|NCT01507896|O1|Outcome|Treatment With BAX326|All participants treated with BAX326 per planned surgical procedure and per unique participant. Data is reported as treatment with BAX326 per planned surgical procedure (including participants who discontinued in the study after treatment with BAX326 but before surgery was done) and per unique participants as a unique participant could be treated with BAX326 for more than one surgical procedure in this study.
215475|NCT01507896|O1|Outcome|Treatment With BAX326|All participants treated with BAX326 per planned surgical procedure and per unique participant. Data is reported as treatment with BAX326 per planned surgical procedure (including participants who discontinued in the study after treatment with BAX326 but before surgery was done) and per unique participants as a unique participant could be treated with BAX326 for more than one surgical procedure in this study.
215476|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
215477|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
215478|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions
215479|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth Minor surgeries.
215480|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
215481|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions.
215482|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
215483|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
215484|NCT01507896|O1|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
215503|NCT01507831|B3|Baseline|Total|Total of all reporting groups
215485|NCT01507896|O1|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
215486|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions.
215487|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
215488|NCT01507896|O1|Outcome|All Surgical Procedures|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
215489|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions.
215490|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
215491|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
215492|NCT01507896|O1|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient com fort. It generally referred to major orthopedic (e.g., joint replacement), major abdom inal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatom ical space. Several tooth extractions or extraction of the third molar were generally considered as major.
215493|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions
215494|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
215495|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
215496|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions.
215497|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
215498|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
215499|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions.
215500|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
215609|NCT01507246|O2|Outcome|EXPAREL|Group receiving EXPAREL
215508|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215509|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215510|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215511|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215512|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215513|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215514|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215515|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215516|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215517|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215518|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215519|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215520|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215521|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215522|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215523|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215524|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215525|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215526|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215527|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215528|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215529|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215530|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215531|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215532|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215533|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215534|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215535|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215536|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215537|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215538|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215539|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215540|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215541|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215542|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215543|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215544|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215545|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215546|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215547|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215548|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215549|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215550|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215551|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215552|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215553|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215554|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215555|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215556|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215557|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215558|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215559|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215560|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215561|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215562|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215563|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215564|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215565|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215566|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215567|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215568|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215569|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215570|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215571|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215572|NCT01507831|E2|Reported Event|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
215573|NCT01507831|E1|Reported Event|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
215574|NCT01507662|B3|Baseline|Total|Total of all reporting groups
215575|NCT01507662|B2|Baseline|Control|Usual care
215576|NCT01507662|B1|Baseline|BMD Result Letter and Brochure|"Patients who receive the intervention - BMD result letter with brochure~Bone Mineral Density Result Letter and Bone Health Brochure: Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information."
215577|NCT01507662|P2|Participant Flow|Control|Usual care
215578|NCT01507662|P1|Participant Flow|BMD Result Letter and Brochure|"Patients who receive the intervention - BMD result letter with brochure~Bone Mineral Density Result Letter and Bone Health Brochure: Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information."
215579|NCT01507662|O2|Outcome|Control|Usual care
215580|NCT01507662|O1|Outcome|BMD Result Letter and Brochure|"Patients who receive the intervention - BMD result letter with brochure~Bone Mineral Density Result Letter and Bone Health Brochure: Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information."
215581|NCT01507662|E2|Reported Event|Control|Usual care
215582|NCT01507662|E1|Reported Event|BMD Result Letter and Brochure|"Patients who receive the intervention - BMD result letter with brochure~Bone Mineral Density Result Letter and Bone Health Brochure: Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information."
215583|NCT01507493|B3|Baseline|Total|Total of all reporting groups
215584|NCT01507493|B2|Baseline|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
215585|NCT01507493|B1|Baseline|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
215586|NCT01507493|P2|Participant Flow|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
215587|NCT01507493|P1|Participant Flow|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
215588|NCT01507493|O2|Outcome|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
215589|NCT01507493|O1|Outcome|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
215590|NCT01507493|O2|Outcome|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
215591|NCT01507493|O1|Outcome|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
215592|NCT01507493|O2|Outcome|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
215593|NCT01507493|O1|Outcome|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
215594|NCT01507493|O2|Outcome|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
215595|NCT01507493|O1|Outcome|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
215596|NCT01507493|O2|Outcome|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
215597|NCT01507493|O1|Outcome|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
215598|NCT01507493|E2|Reported Event|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
215599|NCT01507493|E1|Reported Event|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
215600|NCT01507246|B3|Baseline|Total|Total of all reporting groups
215601|NCT01507246|B2|Baseline|EXPAREL Group|Group receiving EXPAREL
215602|NCT01507246|B1|Baseline|PCA/Opioid Group|Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
215603|NCT01507246|P2|Participant Flow|EXPAREL Group|Group receiving EXPAREL
215604|NCT01507246|P1|Participant Flow|PCA/Opioid Group|Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
215605|NCT01507246|O2|Outcome|EXPAREL Group|Group receiving EXPAREL
215606|NCT01507246|O1|Outcome|PCA/Opioid Group|Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
215607|NCT01507246|O2|Outcome|EXPAREL|Group receiving EXPAREL
215608|NCT01507246|O1|Outcome|PCA/Opioid Group|Group receiving standardized IV morphine or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
215610|NCT01507246|O1|Outcome|PCA/Opioid Group|Group receiving standardized IV morphine or Sponsor-approved equivalent via PCA pump postsurgically, as need.
215611|NCT01507246|O2|Outcome|EXPAREL|Group receiving EXPAREL
215612|NCT01507246|O1|Outcome|PCA/Opioid Group|Group receiving standardized IV morphine or Sponsor-approved equivalent via PCA pump postsurgically, as need.
215613|NCT01507246|E2|Reported Event|EXPAREL Group|Group receiving EXPAREL
215614|NCT01507246|E1|Reported Event|PCA/Opioid Group|Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
215615|NCT01507233|B3|Baseline|Total|Total of all reporting groups
215616|NCT01507233|B2|Baseline|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
215617|NCT01507233|B1|Baseline|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
215618|NCT01507233|P2|Participant Flow|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
215619|NCT01507233|P1|Participant Flow|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
215620|NCT01507233|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
215621|NCT01507233|O1|Outcome|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
215622|NCT01507233|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
215623|NCT01507233|O1|Outcome|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
215624|NCT01507233|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
215625|NCT01507233|O1|Outcome|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
215626|NCT01507233|E2|Reported Event|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
215627|NCT01507233|E1|Reported Event|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
215628|NCT01507220|B3|Baseline|Total|Total of all reporting groups
215629|NCT01507220|B2|Baseline|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)~bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
215646|NCT01507181|P2|Participant Flow|Midazolam|"single dose IV midazolam, .45mg/kg~Midazolam: single dose IV midazolam, .45mg/kg infused over 40 minutes"
215647|NCT01507181|P1|Participant Flow|Ketamine|"single dose IV ketamine, .5mg/kg~Ketamine: single dose IV ketamine, .5mg/kg infused over 40 minutes"
215648|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
215630|NCT01507220|B1|Baseline|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
215631|NCT01507220|P2|Participant Flow|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)~bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
215632|NCT01507220|P1|Participant Flow|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
215633|NCT01507220|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)~bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
215634|NCT01507220|O1|Outcome|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
215635|NCT01507220|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)~bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
215636|NCT01507220|O1|Outcome|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
215637|NCT01507220|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)~bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
215638|NCT01507220|O1|Outcome|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
215639|NCT01507220|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)~bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
215640|NCT01507220|O1|Outcome|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
215641|NCT01507220|E2|Reported Event|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)~bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
215642|NCT01507220|E1|Reported Event|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
215643|NCT01507181|B3|Baseline|Total|Total of all reporting groups
215644|NCT01507181|B2|Baseline|Midazolam|single dose IV midazolam, .45mg/kg
215645|NCT01507181|B1|Baseline|Ketamine|single dose IV ketamine, .5mg/kg
215649|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
215658|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
215659|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
215660|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
215661|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
215662|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
215663|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
215664|NCT01507181|E2|Reported Event|Midazolam|single dose IV midazolam, .45mg/kg
215665|NCT01507181|E1|Reported Event|Ketamine|single dose IV ketamine, .5mg/kg
215666|NCT01507155|B1|Baseline|Clinician-Reported Outcomes|"Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing.~Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders"
215667|NCT01507155|P2|Participant Flow|Patient-Reported Measures|Patients age 18 and older with a diagnosis of Major Depressive Disorder or Generalized Anxiety disorder who receive genetic testing using the Genecept Assay and used self-reported patient scales to measure clinical improvements.
215668|NCT01507155|P1|Participant Flow|Clincian-Reported Outcomes|"Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing.~Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders"
215669|NCT01507155|O1|Outcome|Clinician's Utilizing Assay Guided Treatment in Psychiatry|"Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing.~Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders"
215670|NCT01507155|O1|Outcome|Clinician's Utilizing Assay Guided Treatment in Psychiatry|"Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing.~Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders"
215671|NCT01507155|E2|Reported Event|Patient-Reported Outcomes|Patients age 18 and older with a diagnosis of Major Depressive Disorder or Generalized Anxiety disorder who receive genetic testing using the Genecept Assay and used self-reported patient scales to measure clinical improvements.
215672|NCT01507155|E1|Reported Event|Clinician-Reported Outcomes|"Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing.~Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders"
215673|NCT01507103|B4|Baseline|Total|Total of all reporting groups
215674|NCT01507103|B3|Baseline|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
215675|NCT01507103|B2|Baseline|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
215676|NCT01507103|B1|Baseline|Chemoradiotherapy+Tecemotide (L-BLP25)+CPA|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
215677|NCT01507103|P3|Participant Flow|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
215678|NCT01507103|P2|Participant Flow|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
215679|NCT01507103|P1|Participant Flow|Chemoradiotherapy+Tecemotide (L-BLP25)+CPA|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
215680|NCT01507103|O3|Outcome|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
215681|NCT01507103|O2|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
215682|NCT01507103|O1|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
215683|NCT01507103|O3|Outcome|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
215708|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
215684|NCT01507103|O2|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
215685|NCT01507103|O1|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
215686|NCT01507103|O3|Outcome|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
215687|NCT01507103|O2|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
215688|NCT01507103|O1|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
215689|NCT01507103|O3|Outcome|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
215690|NCT01507103|O2|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
215691|NCT01507103|O1|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
215692|NCT01507103|O3|Outcome|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
215693|NCT01507103|O2|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
215694|NCT01507103|O1|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
215695|NCT01507103|O3|Outcome|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
215696|NCT01507103|O2|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
215697|NCT01507103|O1|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
215698|NCT01507103|E3|Reported Event|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
215699|NCT01507103|E2|Reported Event|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
215700|NCT01507103|E1|Reported Event|Chemoradiotherapy+Tecemotide (L-BLP25)+CPA|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
215701|NCT01507090|B1|Baseline|Normal Children|Otherwise healthy children 2 months to 16 years of age.
215702|NCT01507090|P1|Participant Flow|Normal Children|Otherwise healthy children 2 months to 16 years of age were enrolled. The 2D and 3D Mercy TAPE was developed to measure two upper arm landmarks so as to arrive at the weight estimate for a given child. The 2D Mercy TAPE requires two serial measurements with simple addition. The 3D TAPE makes both measurements simultaneously also requiring simple addition.
215703|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
215704|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
215705|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
215706|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
215707|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
215709|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
215710|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
215711|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
215712|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
215713|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
215714|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
215715|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
215716|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
215717|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
215718|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
215719|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
215720|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
215721|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
215722|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
215723|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
215724|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
215725|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
215726|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
215727|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
215728|NCT01507090|O3|Outcome|Mercy Method|Study coordinators performing measurements
215729|NCT01507090|O2|Outcome|3D-TAPE|Study coordinators performing measurements
215730|NCT01507090|O1|Outcome|2D-TAPE|Study coordinators performing measurements
215731|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
215732|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
215733|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
215734|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
215735|NCT01507090|E1|Reported Event|Normal Children|Otherwise healthy children 2 months to 16 years of age.
215736|NCT01507051|B5|Baseline|Total|Total of all reporting groups
215737|NCT01507051|B4|Baseline|Warfarin Alone|Days -6 to -1 (could be prolonged by 2 days): dose 15 mg to 2.5 mg, dosing depending on INR
215738|NCT01507051|B3|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215739|NCT01507051|B2|Baseline|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215740|NCT01507051|B1|Baseline|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215741|NCT01507051|P4|Participant Flow|Group D: Warfarin Alone|Days -6 to -1 (could be prolonged by 2 days): dose 15 mg to 2.5 mg, dosing depending on INR
215742|NCT01507051|P3|Participant Flow|Group C: Rivaroxaban Without Any Pre-treatment With Warfarin|Days 0 to 3: 20 mg rivaroxaban once daily
215743|NCT01507051|P2|Participant Flow|Group B: Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215744|NCT01507051|P1|Participant Flow|Group A: Warfarin Followed by Rivaroxaban|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215745|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215746|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215747|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215748|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215749|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215750|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215751|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215752|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215753|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215754|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215755|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215756|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215757|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215758|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215759|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215760|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215761|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215762|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215763|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215764|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215765|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215766|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215767|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215768|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215769|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215770|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215771|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215772|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215773|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215774|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215775|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215776|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215777|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215778|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215779|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215892|NCT01506908|O2|Outcome|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
215893|NCT01506908|O1|Outcome|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
215780|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215781|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215782|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215783|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215784|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215785|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215786|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215787|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215788|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215789|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215790|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215791|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215792|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215793|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215794|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215795|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215796|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215797|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215798|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215799|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215800|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215801|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215802|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215803|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215804|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215805|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215806|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215807|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215808|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215809|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215810|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215811|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215812|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215813|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215814|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215815|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215816|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215817|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215818|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215819|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215820|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215821|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215822|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215823|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215824|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215825|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215826|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215827|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215828|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215829|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215830|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215831|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215832|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215833|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215834|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215894|NCT01506908|O2|Outcome|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
215895|NCT01506908|O1|Outcome|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
215835|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215836|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215837|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215838|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215839|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215840|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215841|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215842|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215843|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215844|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215845|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215846|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215847|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215848|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215849|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215850|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215851|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215852|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215853|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215854|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
215855|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
215856|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
215857|NCT01507051|E4|Reported Event|RG4: Warfarin Alone|All participants received warfarin in the Run-In Phase, who either received rivaroxaban or placebo afterwards, or discontinued the study. Days -6 to -1(could be prolonged by 2 days): dose 15 mg to 2.5 mg, dosing depending on INR. Note: Safety Data presented here include participants listed in Groups A, B (warfarin run-in only) and D of the Participant Flow section.
215858|NCT01507051|E3|Reported Event|RG3: Rivaroxaban|All participants received rivaroxaban. Days 0 to 3: 20 mg rivaroxaban once daily. Note: Safety Data presented here include participants listed in Group C of the Participant Flow section.
215859|NCT01507051|E2|Reported Event|RG2: Warfarin Followed by Placebo|All participants received warfarin and later placebo. Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily. Note: Safety Data presented here include participants listed in Group B of the Participant Flow section.
215896|NCT01506908|O2|Outcome|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
215897|NCT01506908|O1|Outcome|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
215860|NCT01507051|E1|Reported Event|RG1: Warfarin Followed by Rivaroxaban|All participants received warfarin and later rivaroxaban. Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily. Note: Safety Data presented here include participants listed in Group A of the Participant Flow section.
215861|NCT01506960|B1|Baseline|Subjects Having NIRS/IVUS and OCT Imaging During PCI.|
215862|NCT01506960|P1|Participant Flow|Coronary Stenting With OCT, NIRS/IVUS|All subjects will have Near Infrared Spectroscopy/Intravascular Ultrasound Imaging performed.
215863|NCT01506960|O2|Outcome|Deep Lipid|
215864|NCT01506960|O1|Outcome|Superficial Lipid|
215865|NCT01506960|O1|Outcome|Subjects Having NIRS/IVUS and OCT Imaging During PCI.|
215866|NCT01506960|E1|Reported Event|Subjects Having NIRS/IVUS and OCT Imaging During PCI.|
215867|NCT01506947|B1|Baseline|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
215868|NCT01506947|P1|Participant Flow|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
215869|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
215870|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
215871|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
215872|NCT01506947|O2|Outcome|Month 6|
215873|NCT01506947|O1|Outcome|Baseline|
215874|NCT01506947|O2|Outcome|Month 6|
215875|NCT01506947|O1|Outcome|Baseline|
215876|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
215877|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
215878|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
215879|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
215880|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
215881|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
215882|NCT01506947|E1|Reported Event|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
215883|NCT01506908|B3|Baseline|Total|Total of all reporting groups
215884|NCT01506908|B2|Baseline|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
215885|NCT01506908|B1|Baseline|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
215886|NCT01506908|P2|Participant Flow|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
215887|NCT01506908|P1|Participant Flow|Nicotine Lozenge 4 Milligrams (mg)|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
215888|NCT01506908|O2|Outcome|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
215889|NCT01506908|O1|Outcome|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
215890|NCT01506908|O2|Outcome|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
215891|NCT01506908|O1|Outcome|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
215898|NCT01506908|O2|Outcome|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
215899|NCT01506908|O1|Outcome|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
215900|NCT01506908|E2|Reported Event|Placebo Lozenge|Participants received a single dose of matched placebo mint lozenge, through oral route.
215901|NCT01506908|E1|Reported Event|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
215902|NCT01506882|B3|Baseline|Total Title|
215903|NCT01506882|B2|Baseline|Levetiracetam 3000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.~Frequency: Twice daily"
215904|NCT01506882|B1|Baseline|Levetiracetam 1000 mg/Day to 2000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.~Frequency: Twice daily"
215905|NCT01506882|P2|Participant Flow|Levetiracetam 3000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.~Frequency: Twice daily"
215906|NCT01506882|P1|Participant Flow|Levetiracetam 1000 mg/Day to 2000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.~Frequency: Twice daily"
215907|NCT01506882|O1|Outcome|Levetiracetam 3000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.~Frequency: Twice daily"
215908|NCT01506882|O1|Outcome|Full Analysis Set (LEV 3000 mg/Day Group)|"FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.~Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.~Frequency: Twice daily"
215909|NCT01506882|O1|Outcome|Full Analysis Set (LEV 1000 mg/Day to 2000 mg/Day Group)|"FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.~Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.~Frequency: Twice daily"
215910|NCT01506882|O1|Outcome|Full Analysis Set (LEV 1000 mg/Day to 2000 mg/Day Group)|"FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.~Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.~Frequency: Twice daily"
215911|NCT01506882|O1|Outcome|Full Analysis Set (LEV 3000 mg/Day Group)|"FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.~Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.~Frequency: Twice daily"
215912|NCT01506882|O1|Outcome|Levetiracetam 3000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.~Frequency: Twice daily"
215913|NCT01506882|O1|Outcome|Full Analysis Set (LEV 1000 mg/Day to 2000 mg/Day Group)|"FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.~Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.~Frequency: Twice daily"
215914|NCT01506882|O1|Outcome|Levetiracetam 1000 mg/Day to 2000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.~Frequency: Twice daily"
215915|NCT01506882|E2|Reported Event|Levetiracetam 3000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.~Frequency: Twice daily"
215916|NCT01506882|E1|Reported Event|Levetiracetam 1000 mg/Day to 2000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.~Frequency: Twice daily"
215917|NCT01506726|B3|Baseline|Total|Total of all reporting groups
215918|NCT01506726|B2|Baseline|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
215919|NCT01506726|B1|Baseline|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
216021|NCT01506193|B1|Baseline|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
215920|NCT01506726|P2|Participant Flow|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
215921|NCT01506726|P1|Participant Flow|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
215922|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
215923|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
215924|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
215925|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
215926|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
215927|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
215928|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
215929|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
215930|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
215931|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
215932|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
215933|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
216067|NCT01505881|E2|Reported Event|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
215934|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
215935|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
215936|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
215937|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
215938|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
215939|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
215940|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
215941|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
215942|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
215943|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
215944|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
215945|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
215946|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
215947|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
216068|NCT01505881|E1|Reported Event|Dabigatran Etexilate|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily
216069|NCT01505764|B3|Baseline|Total|Total of all reporting groups
215948|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
215949|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
215950|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
215951|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
215952|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
215953|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
215954|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
215955|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
215956|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
215957|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
215958|NCT01506726|E2|Reported Event|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
215959|NCT01506726|E1|Reported Event|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
215960|NCT01506596|B1|Baseline|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
215961|NCT01506596|P1|Participant Flow|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
216022|NCT01506193|P3|Participant Flow|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
215962|NCT01506596|O1|Outcome|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
215963|NCT01506596|O1|Outcome|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
215964|NCT01506596|O1|Outcome|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
215965|NCT01506596|O1|Outcome|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
215966|NCT01506596|O1|Outcome|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
215967|NCT01506596|E1|Reported Event|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
215968|NCT01506479|B4|Baseline|Total|Total of all reporting groups
215969|NCT01506479|B3|Baseline|Moderate Exercise|"Endurance exercise at 60-65% HR max, 4x/wk for 6 months.~Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months."
215970|NCT01506479|B2|Baseline|Vigorous Exercise|"Endurance exercise at 80-85% HR max, 4x/wk for 6 months.~Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months."
215971|NCT01506479|B1|Baseline|Control Group|"Wait listed to moderate or vigorous exercise after 6 months of no exercise.~No Intervention: No-exercise control (i.e., usual care);"
215972|NCT01506479|P3|Participant Flow|Moderate Exercise|"Endurance exercise at 60-65% HR max, 4x/wk for 6 months.~Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months."
215973|NCT01506479|P2|Participant Flow|Vigorous Exercise|"Endurance exercise at 80-85% HR max, 4x/wk for 6 months.~Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months."
215974|NCT01506479|P1|Participant Flow|Control Group|"Wait listed to moderate or vigorous exercise after 6 months of no exercise.~No Intervention: No-exercise control (i.e., usual care);"
215975|NCT01506479|O2|Outcome|Moderate Exercise|"Endurance exercise at 60-65% HR max, 4x/wk for 6 months.~Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months."
215976|NCT01506479|O1|Outcome|Vigorous Exercise|"Endurance exercise at 80-85% HR max, 4x/wk for 6 months.~Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months."
215977|NCT01506479|O3|Outcome|Moderate Exercise|"Endurance exercise at 60-65% HR max, 4x/wk for 6 months.~Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months."
215978|NCT01506479|O2|Outcome|Vigorous Exercise|"Endurance exercise at 80-85% HR max, 4x/wk for 6 months.~Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months."
215979|NCT01506479|O1|Outcome|Control Group|"Wait listed to moderate or vigorous exercise after 6 months of no exercise.~No Intervention: No-exercise control (i.e., usual care);"
215980|NCT01506479|O2|Outcome|Moderate Exercise|"Endurance exercise at 60-65% HR max, 4x/wk for 6 months.~Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months."
215981|NCT01506479|O1|Outcome|Vigorous Exercise|"Endurance exercise at 80-85% HR max, 4x/wk for 6 months.~Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months."
215982|NCT01506479|E3|Reported Event|Moderate Exercise|"Endurance exercise at 60-65% HR max, 4x/wk for 6 months.~Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months."
215983|NCT01506479|E2|Reported Event|Vigorous Exercise|"Endurance exercise at 80-85% HR max, 4x/wk for 6 months.~Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months."
215984|NCT01506479|E1|Reported Event|Control Group|"Wait listed to moderate or vigorous exercise after 6 months of no exercise.~No Intervention: No-exercise control (i.e., usual care);"
215985|NCT01506362|B1|Baseline|A Synthetic Oligonucleotide for Treatment of IBD.|"BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~BL-7040: BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~Study duration can last up to 8 weeks, including up to 9 days in the screening period, up to 5 weeks of treatment with BL-7040, and up to 2 weeks for follow up.~BL-7040 12 mg QD for 19-21 days followed by BL-7040 40 mg QD for 14 days."
215986|NCT01506362|P1|Participant Flow|A Synthetic Oligonucleotide for Treatment of IBD.|"BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~Study duration can last up to 8 weeks, including up to 9 days in the screening period, up to 5 weeks of treatment with BL-7040, and up to 2 weeks for follow up.~BL-7040 12 mg QD for 19-21 days followed by BL-7040 40 mg QD for 14 days."
216070|NCT01505764|B2|Baseline|Arm 2|"Placebo~Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day."
215987|NCT01506362|O1|Outcome|A Synthetic Oligonucleotide for Treatment of IBD.|"BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~BL-7040: BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~Study duration can last up to 8 weeks, including up to 9 days in the screening period, up to 5 weeks of treatment with BL-7040, and up to 2 weeks for follow up.~BL-7040 12 mg QD for 19-21 days followed by BL-7040 40 mg QD for 14 days."
215988|NCT01506362|E1|Reported Event|A Synthetic Oligonucleotide for Treatment of IBD.|"BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~BL-7040: BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~Study duration can last up to 8 weeks, including up to 9 days in the screening period, up to 5 weeks of treatment with BL-7040, and up to 2 weeks for follow up.~BL-7040 12 mg QD for 19-21 days followed by BL-7040 40 mg QD for 14 days."
215989|NCT01506323|B3|Baseline|Total|Total of all reporting groups
215990|NCT01506323|B2|Baseline|Present Centered Therapy (PCT)|Present Centered Individual Therapy (PCT): The PCT is a form of individual therapy that is problem-oriented to improve current coping. It avoids details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention control arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training.
215991|NCT01506323|B1|Baseline|Mantram Repetition Program (MRP)|The Mantram Repetition Program (MRP) teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP was delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
215992|NCT01506323|P2|Participant Flow|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically avoids actual details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training.
215993|NCT01506323|P1|Participant Flow|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP was delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
215994|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCIT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
215995|NCT01506323|O1|Outcome|Arm 1: Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
215996|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
215997|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
215998|NCT01506323|O2|Outcome|Arm 2: Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
216909|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
215999|NCT01506323|O1|Outcome|Arm 1: Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
216000|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
216001|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
216002|NCT01506323|O2|Outcome|Arm 2: Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
216003|NCT01506323|O1|Outcome|Arm 1: Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
216004|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
216005|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
216006|NCT01506323|O2|Outcome|Present Centered Therapy|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
216007|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
216008|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)`|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
216023|NCT01506193|P2|Participant Flow|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216071|NCT01505764|B1|Baseline|Arm 1|"Anamorelin HCl~Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day."
216009|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
216010|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
216011|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
216012|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
216013|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
216014|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
216015|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
216016|NCT01506323|E2|Reported Event|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
216017|NCT01506323|E1|Reported Event|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
216018|NCT01506193|B4|Baseline|Total|Total of all reporting groups
216019|NCT01506193|B3|Baseline|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216020|NCT01506193|B2|Baseline|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216066|NCT01505881|O1|Outcome|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
216122|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216024|NCT01506193|P1|Participant Flow|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216025|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216026|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216027|NCT01506193|O3|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216028|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216029|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216030|NCT01506193|O3|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216031|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216032|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216033|NCT01506193|O3|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216034|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216035|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216036|NCT01506193|O3|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216037|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216038|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216039|NCT01506193|O3|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216040|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216041|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216123|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216042|NCT01506193|O3|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216043|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216044|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216045|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216046|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216047|NCT01506193|O2|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216048|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216049|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216050|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216051|NCT01506193|E3|Reported Event|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216052|NCT01506193|E2|Reported Event|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216053|NCT01506193|E1|Reported Event|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
216054|NCT01505881|B3|Baseline|Total|Total of all reporting groups
216055|NCT01505881|B2|Baseline|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
216056|NCT01505881|B1|Baseline|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily
216057|NCT01505881|P2|Participant Flow|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
216058|NCT01505881|P1|Participant Flow|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
216059|NCT01505881|O2|Outcome|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
216060|NCT01505881|O1|Outcome|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
216061|NCT01505881|O2|Outcome|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
216062|NCT01505881|O1|Outcome|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
216063|NCT01505881|O2|Outcome|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator.
216064|NCT01505881|O1|Outcome|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
216065|NCT01505881|O2|Outcome|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
216910|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
216072|NCT01505764|P2|Participant Flow|Arm 2|"Placebo~Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day."
216073|NCT01505764|P1|Participant Flow|Arm 1|"Anamorelin HCl~Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day."
216074|NCT01505764|O2|Outcome|Arm 2|"Placebo~Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day."
216075|NCT01505764|O1|Outcome|Arm 1|"Anamorelin HCl~Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day."
216076|NCT01505764|E2|Reported Event|Arm 2|"Placebo~Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day."
216077|NCT01505764|E1|Reported Event|Arm 1|"Anamorelin HCl~Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day."
216078|NCT01505673|B3|Baseline|Total|Total of all reporting groups
216079|NCT01505673|B2|Baseline|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216080|NCT01505673|B1|Baseline|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216081|NCT01505673|P2|Participant Flow|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216082|NCT01505673|P1|Participant Flow|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216083|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216084|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216085|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216086|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216087|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216088|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216089|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216090|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216091|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216092|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216093|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216094|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216095|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216096|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216097|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216098|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216099|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216100|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216101|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216102|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216103|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216104|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216105|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216106|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216107|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216108|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216109|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216110|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216111|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216112|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216113|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216114|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216115|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216116|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216117|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216118|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216119|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216120|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216121|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216911|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
216124|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216125|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216126|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216127|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216128|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216129|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216130|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216131|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216132|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216133|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216134|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216135|NCT01505673|O2|Outcome|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216136|NCT01505673|O1|Outcome|Liraglutide|Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
216137|NCT01505673|E2|Reported Event|Saline Injection|Saline: Placebo injection of 1.8mg saline once daily for 6-months
216138|NCT01505673|E1|Reported Event|Liraglutide|Liraglutide: Liraglutide 1.8mg injected subcutaneously from pen device once daily for 6-months
216139|NCT01505647|B3|Baseline|Total|Total of all reporting groups
216140|NCT01505647|B2|Baseline|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
216141|NCT01505647|B1|Baseline|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
216142|NCT01505647|P2|Participant Flow|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
216143|NCT01505647|P1|Participant Flow|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live Alternative Manufacturing Process (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
216144|NCT01505647|O2|Outcome|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
216145|NCT01505647|O1|Outcome|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
216146|NCT01505647|O2|Outcome|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
216147|NCT01505647|O1|Outcome|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
216148|NCT01505647|O2|Outcome|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
216149|NCT01505647|O1|Outcome|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
216150|NCT01505647|O2|Outcome|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
216151|NCT01505647|O1|Outcome|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
216152|NCT01505647|O2|Outcome|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
216153|NCT01505647|O1|Outcome|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
216154|NCT01505647|E2|Reported Event|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
216155|NCT01505647|E1|Reported Event|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
216156|NCT01505608|B3|Baseline|Total|Total of all reporting groups
216157|NCT01505608|B2|Baseline|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
216158|NCT01505608|B1|Baseline|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
216159|NCT01505608|P2|Participant Flow|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
216200|NCT01505387|E1|Reported Event|Placebo|"Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal)~Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)"
216201|NCT01505374|B1|Baseline|All Study Participants|
216202|NCT01505374|P2|Participant Flow|Study Technique Left Leg, Control Technique Right Leg|
216203|NCT01505374|P1|Participant Flow|Study Technique Right Leg, Control Technique Left Leg|
216204|NCT01505374|O1|Outcome|All Patients|
216160|NCT01505608|P1|Participant Flow|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~During Phase 2- Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
216161|NCT01505608|O2|Outcome|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
216162|NCT01505608|O1|Outcome|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
216163|NCT01505608|O2|Outcome|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
216164|NCT01505608|O1|Outcome|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
216165|NCT01505608|O2|Outcome|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
216166|NCT01505608|O1|Outcome|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
216167|NCT01505608|O2|Outcome|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
216168|NCT01505608|O1|Outcome|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
216169|NCT01505608|O2|Outcome|Phase I Patients + Phase II Assigned Arm B- Tmz +I+ TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
216205|NCT01505374|O1|Outcome|All Patients|
216206|NCT01505374|O1|Outcome|All Patients|
216564|NCT01502371|P5|Participant Flow|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
216170|NCT01505608|O1|Outcome|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
216171|NCT01505608|O2|Outcome|Arm A- TMZ + Irinotecan Only|Did not receive TPI 287
216172|NCT01505608|O1|Outcome|TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
216173|NCT01505608|E2|Reported Event|Phase II Arm A- Subjects That Did Not Receive TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
216174|NCT01505608|E1|Reported Event|TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
216175|NCT01505465|B3|Baseline|Total|Total of all reporting groups
216176|NCT01505465|B2|Baseline|Control: Placebo|Placebo: 5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery
216177|NCT01505465|B1|Baseline|Study: Melatonin|Melatonin: 5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.
216178|NCT01505465|P2|Participant Flow|Control: Placebo|Placebo: 5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery
216179|NCT01505465|P1|Participant Flow|Study: Melatonin|Melatonin: 5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.
216180|NCT01505465|O2|Outcome|Control: Placebo|Placebo: 5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery
216181|NCT01505465|O1|Outcome|Study: Melatonin|Melatonin: 5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.
216182|NCT01505465|O2|Outcome|Control: Placebo|Placebo: 5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery
216183|NCT01505465|O1|Outcome|Study: Melatonin|Melatonin: 5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.
216184|NCT01505465|O2|Outcome|Control: Placebo|Placebo: 5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery
216185|NCT01505465|O1|Outcome|Study: Melatonin|Melatonin: 5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.
216186|NCT01505465|O2|Outcome|Control: Placebo|Placebo: 5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery
216187|NCT01505465|O1|Outcome|Study: Melatonin|Melatonin: 5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.
216188|NCT01505465|O2|Outcome|Control: Placebo|Placebo: 5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery
216189|NCT01505465|O1|Outcome|Study: Melatonin|Melatonin: 5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.
216190|NCT01505465|E2|Reported Event|Control: Placebo|Placebo: 5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery
216191|NCT01505465|E1|Reported Event|Study: Melatonin|Melatonin: 5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.
216192|NCT01505387|B3|Baseline|Total|Total of all reporting groups
216193|NCT01505387|B2|Baseline|Litramine|"Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)~Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)"
216194|NCT01505387|B1|Baseline|Placebo|"Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal)~Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)"
216195|NCT01505387|P2|Participant Flow|Litramine|"Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)~Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)"
216196|NCT01505387|P1|Participant Flow|Placebo|"Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal)~Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)"
216197|NCT01505387|O2|Outcome|Litramine|"Fibre complex of plant origin n tablet form 2 tablets 3 times daily (oral consumption, after meal)~Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)"
216198|NCT01505387|O1|Outcome|Placebo|"Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal)~Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)"
216199|NCT01505387|E2|Reported Event|Litramine|"Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)~Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)"
216912|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
216207|NCT01505374|O2|Outcome|Control Technique: Femoral Nerve Block|Control Technique: The other leg will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
216208|NCT01505374|O1|Outcome|Study Technique: Saphenous Nerve Block|Study Technique: One leg will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
216209|NCT01505374|O2|Outcome|Control Technique: Femoral Nerve Block|Control Technique: The other leg will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
216210|NCT01505374|O1|Outcome|Study Technique: Saphenous Nerve Block|Study Technique: One leg will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
216211|NCT01505374|O1|Outcome|All Patients|
216212|NCT01505374|O2|Outcome|Control Technique: Femoral Nerve Block|Control Technique: The other leg will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
216213|NCT01505374|O1|Outcome|Study Technique: Saphenous Nerve Block|Study Technique: One leg will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
216214|NCT01505374|E2|Reported Event|Control Technique: Femoral Nerve Block|
216215|NCT01505374|E1|Reported Event|Study Technique: Saphenous Nerve Block|
216216|NCT01505166|B4|Baseline|Total|Total of all reporting groups
216217|NCT01505166|B3|Baseline|Placebo (Part 2)|"Patients will receive placebo (Group B) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.~Placebo: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216218|NCT01505166|B2|Baseline|Vigil™ (Part 2)|"Patients will receive 1 x 10^7 cells (Group A) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses (vaccine) starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216219|NCT01505166|B1|Baseline|Vigil™ Vaccine (Part 1) 6 Patient run-in|"Six patients will be enrolled into the Part 1 of the study to receive intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7 cells/injection; maximum of 12 vaccinations).~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216220|NCT01505166|P3|Participant Flow|Placebo (Part 2)|"Patients will receive placebo (Group B) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.~Placebo: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216221|NCT01505166|P2|Participant Flow|Vigil™ (Part 2)|"Patients will receive 1 x 10^7 cells (Group A) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses (vaccine) starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216264|NCT01504997|E1|Reported Event|Robot Assisted Distal Gastrectomy|"patients who received robot assisted distal gastrectomy~Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy"
216265|NCT01504971|B1|Baseline|Gastroesophageal Reflux Disease (GERD)|"symptom questionaire: GerdQ questionaire~pH monitoring: 24-hour pH monitoring~Tri-modal imaging endoscopy: To investigate WLI,NBI and AFI~rabeprazole: 10mg, bid, p.o."
216565|NCT01502371|P4|Participant Flow|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
216222|NCT01505166|P1|Participant Flow|Vigil™ Vaccine (Part 1) - 6 Patient run-in|"Six patients will be enrolled into the Part 1 of the study to receive intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7 cells/injection; maximum of 12 vaccinations).~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216223|NCT01505166|O3|Outcome|Placebo (Part 2)|"Patients will receive placebo (Group B) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.~Placebo: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216224|NCT01505166|O2|Outcome|Vigil™ (Part 2)|"Patients will receive 1 x 10^7 cells (Group A) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses (vaccine) starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216225|NCT01505166|O1|Outcome|Vigil™ Vaccine (Part 1) 6 Patient run-in|"Six patients will be enrolled into the Part 1 of the study to receive intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7 cells/injection; maximum of 12 vaccinations).~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216226|NCT01505166|O3|Outcome|Placebo (Part 2)|"Patients will receive placebo (Group B) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.~Placebo: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216227|NCT01505166|O2|Outcome|Vigil™ (Part 2)|"Patients will receive 1 x 10^7 cells (Group A) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses (vaccine) starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216228|NCT01505166|O1|Outcome|Vigil™ Vaccine (Part 1) 6 Patient run-in|"Six patients will be enrolled into the Part 1 of the study to receive intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7 cells/injection; maximum of 12 vaccinations).~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216229|NCT01505166|O3|Outcome|Placebo (Part 2)|"Patients will receive placebo (Group B) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.~Placebo: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216230|NCT01505166|O2|Outcome|Vigil™ (Part 2)|"Patients will receive 1 x 10^7 cells (Group A) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses (vaccine) starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216231|NCT01505166|O1|Outcome|Vigil™ Vaccine (Part 1) - 6 Patient run-in|"Six patients will be enrolled into the Part 1 of the study to receive intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7 cells/injection; maximum of 12 vaccinations).~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216232|NCT01505166|O3|Outcome|Placebo (Part 2)|"Patients will receive placebo (Group B) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.~Placebo: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216233|NCT01505166|O2|Outcome|Vigil™ (Part 2)|"Patients will receive 1 x 10^7 cells (Group A) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses (vaccine) starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216234|NCT01505166|O1|Outcome|Vigil™ Vaccine (Part 1) 6 Patient run-in|"Six patients will be enrolled into the Part 1 of the study to receive intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7 cells/injection; maximum of 12 vaccinations).~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216235|NCT01505166|O3|Outcome|Placebo (Part 2)|"Patients will receive placebo (Group B) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.~Placebo: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216236|NCT01505166|O2|Outcome|Vigil™ (Part 2)|"Patients will receive 1 x 10^7 cells (Group A) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses (vaccine) starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216237|NCT01505166|O1|Outcome|Vigil™ Vaccine (Part 1) - 6 Patient run-in|"Six patients will be enrolled into the Part 1 of the study to receive intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7 cells/injection; maximum of 12 vaccinations).~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216238|NCT01505166|O3|Outcome|Placebo|"Patients will receive placebo (Group B) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.~Placebo: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216239|NCT01505166|O2|Outcome|Vigil™|"Patients will receive 1 x 10^7 cells (Group A) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses (vaccine) starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216240|NCT01505166|O1|Outcome|Vigil™ Vaccine (6 Patient run-in)|"Six patients will be enrolled into the Part 1 of the study to receive intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7 cells/injection; maximum of 12 vaccinations).~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216241|NCT01505166|E3|Reported Event|Vigil™ Vaccine (6 Patient run-in)|"Six patients will be enrolled into the Part 1 of the study to receive intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7 cells/injection; maximum of 12 vaccinations).~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216242|NCT01505166|E2|Reported Event|Placebo|"Patients will receive placebo (Group B) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.~Placebo: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216243|NCT01505166|E1|Reported Event|Vigil™|"Patients will receive 1 x 10^7 cells (Group A) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses (vaccine) starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.~Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks)."
216244|NCT01505114|B5|Baseline|Total|Total of all reporting groups
216245|NCT01505114|B4|Baseline|Arm 4|"MVC placebo plus FTC 200 mg and TDF 300 mg orally once daily~Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48~Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48~Maraviroc placebo: Once daily from Week 0 through Week 48"
216246|NCT01505114|B3|Baseline|Arm 3|"MVC 300 mg plus FTC placebo and TDF 300 mg orally once daily~Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48~Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48~Emtricitabine placebo: Once daily from Week 0 through Week 48"
216247|NCT01505114|B2|Baseline|Arm 2|"MVC 300 mg plus FTC 200 mg and TDF placebo orally once daily~Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48~Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48~Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48"
216248|NCT01505114|B1|Baseline|Arm 1|"MVC 300 mg plus FTC placebo and TDF placebo orally once daily~Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48~Emtricitabine placebo: Once daily from Week 0 through Week 48~Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48"
216249|NCT01505114|P4|Participant Flow|TDF + FTC|"MVC placebo plus FTC 200 mg and TDF 300 mg orally once daily~Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48~Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48~Maraviroc placebo: Once daily from Week 0 through Week 48"
216250|NCT01505114|P3|Participant Flow|MVC + TDF|"MVC 300 mg plus FTC placebo and TDF 300 mg orally once daily~Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48~Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48~Emtricitabine placebo: Once daily from Week 0 through Week 48"
216251|NCT01505114|P2|Participant Flow|MVC + FTC|"MVC 300 mg plus FTC 200 mg and TDF placebo orally once daily~Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48~Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48~Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48"
216252|NCT01505114|P1|Participant Flow|MVC Only|"MVC 300 mg plus FTC placebo and TDF placebo orally once daily~Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48~Emtricitabine placebo: Once daily from Week 0 through Week 48~Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48"
216253|NCT01505114|O4|Outcome|Arm 4|"MVC placebo plus FTC 200 mg and TDF 300 mg orally once daily~Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48~Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48~Maraviroc placebo: Once daily from Week 0 through Week 48"
216254|NCT01505114|O3|Outcome|Arm 3|"MVC 300 mg plus FTC placebo and TDF 300 mg orally once daily~Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48~Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48~Emtricitabine placebo: Once daily from Week 0 through Week 48"
216255|NCT01505114|O2|Outcome|Arm 2|"MVC 300 mg plus FTC 200 mg and TDF placebo orally once daily~Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48~Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48~Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48"
216256|NCT01505114|O1|Outcome|Arm 1|"MVC 300 mg plus FTC placebo and TDF placebo orally once daily~Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48~Emtricitabine placebo: Once daily from Week 0 through Week 48~Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48"
216257|NCT01505114|E4|Reported Event|Arm 4|"MVC placebo plus FTC 200 mg and TDF 300 mg orally once daily~Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48~Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48~Maraviroc placebo: Once daily from Week 0 through Week 48"
216258|NCT01505114|E3|Reported Event|Arm 3|"MVC 300 mg plus FTC placebo and TDF 300 mg orally once daily~Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48~Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48~Emtricitabine placebo: Once daily from Week 0 through Week 48"
216259|NCT01505114|E2|Reported Event|Arm 2|"MVC 300 mg plus FTC 200 mg and TDF placebo orally once daily~Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48~Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48~Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48"
216260|NCT01505114|E1|Reported Event|Arm 1|"MVC 300 mg plus FTC placebo and TDF placebo orally once daily~Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48~Emtricitabine placebo: Once daily from Week 0 through Week 48~Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48"
216261|NCT01504997|B1|Baseline|Robot Assisted Distal Gastrectomy|"patients who received robot assisted distal gastrectomy~Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy"
216262|NCT01504997|P1|Participant Flow|Robot Assisted Distal Gastrectomy|"patients who received robot assisted distal gastrectomy~Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy"
216263|NCT01504997|O1|Outcome|Robot Assisted Distal Gastrectomy|"patients who received robot assisted distal gastrectomy~Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy"
216266|NCT01504971|P1|Participant Flow|Gastroesophageal Reflux Disease (GERD)|"symptom questionaire: GerdQ questionaire~pH monitoring: 24-hour pH monitoring~Tri-modal imaging endoscopy: To investigate WLI,NBI and AFI~rabeprazole: 10mg, bid, p.o."
216267|NCT01504971|O3|Outcome|Participants Same to Previous Arm|Diagnostic capabilities of GerdQ in the diagnosis of GERD
216268|NCT01504971|O2|Outcome|Participants Same to arm1|Diagnostic capabilities of Autofluorescence Imaging on Gastroesophageal Reflux Disease
216269|NCT01504971|O1|Outcome|Participants|Diagnostic capabilities of White-light Imaging on Gastroesophageal Reflux Disease
216270|NCT01504971|E3|Reported Event|Participants Same to Previous Arm|Diagnostic capabilities of GerdQ in the diagnosis of GERD
216271|NCT01504971|E2|Reported Event|Participants Same to arm1|Diagnostic capabilities of AFI in the diagnosis of GERD
216272|NCT01504971|E1|Reported Event|Participants|Diagnostic capabilities of WLI in the diagnosis of GERD
216273|NCT01504958|B4|Baseline|Total|Total of all reporting groups
216274|NCT01504958|B3|Baseline|Sham rTMS With Sham Cognitive Training|"High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"
216275|NCT01504958|B2|Baseline|Sham rTMS With Real Cognitive Training|"High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
216276|NCT01504958|B1|Baseline|Active rTMS With Real Cognitive Training|"High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
216277|NCT01504958|P3|Participant Flow|Sham rTMS With Sham Cognitive Training|"High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"
216278|NCT01504958|P2|Participant Flow|Sham rTMS With Real Cognitive Training|"High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
216279|NCT01504958|P1|Participant Flow|Active rTMS With Real Cognitive Training|"High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
216280|NCT01504958|O3|Outcome|Sham rTMS With Sham Cognitive Training|"High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"
216355|NCT01503749|O1|Outcome|Control|Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells
216281|NCT01504958|O2|Outcome|Sham rTMS With Real Cognitive Training|"High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
216282|NCT01504958|O1|Outcome|Active rTMS With Real Cognitive Training|"High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
216283|NCT01504958|O3|Outcome|Sham rTMS With Sham Cognitive Training|"High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"
216284|NCT01504958|O2|Outcome|Sham rTMS With Real Cognitive Training|"High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
216285|NCT01504958|O1|Outcome|Active rTMS With Real Cognitive Training|"High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
216286|NCT01504958|O3|Outcome|Sham rTMS With Sham Cognitive Training|"High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"
216287|NCT01504958|O2|Outcome|Sham rTMS With Real Cognitive Training|"High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
216288|NCT01504958|O1|Outcome|Active rTMS With Real Cognitive Training|"High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
216485|NCT01502761|O2|Outcome|Regional Intra-arterial Magnesium 1.5g|"Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients~Magnesium Sulfate: Intra-arterial"
216289|NCT01504958|E3|Reported Event|Sham rTMS With Sham Cognitive Training|"High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"
216290|NCT01504958|E2|Reported Event|Sham rTMS With Real Cognitive Training|"High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
216291|NCT01504958|E1|Reported Event|Active rTMS With Real Cognitive Training|"High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
216292|NCT01504867|B3|Baseline|Total|Total of all reporting groups
216293|NCT01504867|B2|Baseline|Placebo|This group received matching lactose powder filled capsules on days 1-7.
216294|NCT01504867|B1|Baseline|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
216295|NCT01504867|P2|Participant Flow|Placebo|This group received matching lactose powder filled capsules on days 1-7.
216296|NCT01504867|P1|Participant Flow|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
216297|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
216298|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
216299|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
216300|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
216301|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
216302|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
216303|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
216304|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
216305|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
216306|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
216307|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
216308|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
216309|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
216310|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
216311|NCT01504867|E2|Reported Event|Placebo|This group received matching lactose powder filled capsules on days 1-7.
216312|NCT01504867|E1|Reported Event|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
216313|NCT01504854|B3|Baseline|Total|Total of all reporting groups
216314|NCT01504854|B2|Baseline|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
216315|NCT01504854|B1|Baseline|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
216316|NCT01504854|P2|Participant Flow|Placebo|"Subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
216317|NCT01504854|P1|Participant Flow|Resveratrol|"Subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
216318|NCT01504854|O2|Outcome|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
216791|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216319|NCT01504854|O1|Outcome|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
216320|NCT01504854|O2|Outcome|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
216321|NCT01504854|O1|Outcome|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
216322|NCT01504854|O2|Outcome|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
216323|NCT01504854|O1|Outcome|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
216324|NCT01504854|O2|Outcome|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
216325|NCT01504854|O1|Outcome|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
216326|NCT01504854|O2|Outcome|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
216327|NCT01504854|O1|Outcome|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
216328|NCT01504854|E2|Reported Event|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
216329|NCT01504854|E1|Reported Event|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
216330|NCT01504204|B3|Baseline|Total|Total of all reporting groups
216331|NCT01504204|B2|Baseline|Medication Without Samples|"Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.~Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas."
216332|NCT01504204|B1|Baseline|Medication With Sample and Demonstration|"Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit.~Adapalene + benzoyl peroxide samples: A sample size tube of the study medication, combination adapalene 0.1% plus benzoyl peroxide 2.5% gel, will be provided with instruction on proper application, including demonstration, at the first visit.~Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas."
216333|NCT01504204|P2|Participant Flow|Medication Without Samples|Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.
216334|NCT01504204|P1|Participant Flow|Medication With Sample and Demonstration|Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit.
216335|NCT01504204|O2|Outcome|Medication Without Samples|"Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.~Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas."
216336|NCT01504204|O1|Outcome|Medication With Sample and Demonstration|"Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit.~Adapalene + benzoyl peroxide samples: A sample size tube of the study medication, combination adapalene 0.1% plus benzoyl peroxide 2.5% gel, will be provided with instruction on proper application, including demonstration, at the first visit.~Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas."
216337|NCT01504204|O2|Outcome|Medication Without Samples|"Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.~Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas."
216338|NCT01504204|O1|Outcome|Medication With Sample and Demonstration|"Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit.~Adapalene + benzoyl peroxide samples: A sample size tube of the study medication, combination adapalene 0.1% plus benzoyl peroxide 2.5% gel, will be provided with instruction on proper application, including demonstration, at the first visit.~Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas."
216339|NCT01504204|O2|Outcome|Medication Without Samples|"Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.~Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas."
216340|NCT01504204|O1|Outcome|Medication With Sample and Demonstration|"Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit.~Adapalene + benzoyl peroxide samples: A sample size tube of the study medication, combination adapalene 0.1% plus benzoyl peroxide 2.5% gel, will be provided with instruction on proper application, including demonstration, at the first visit.~Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas."
216341|NCT01504204|E2|Reported Event|Medication Without Samples|"Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.~Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas."
216342|NCT01504204|E1|Reported Event|Medication With Sample and Demonstration|"Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit.~Adapalene + benzoyl peroxide samples: A sample size tube of the study medication, combination adapalene 0.1% plus benzoyl peroxide 2.5% gel, will be provided with instruction on proper application, including demonstration, at the first visit.~Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas."
216343|NCT01503749|B4|Baseline|Total|Total of all reporting groups
216344|NCT01503749|B3|Baseline|Infusion of the Mobilized Peripheral Blood Mononucleated Cells|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells~. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.~Infusion of the mobilized peripheral blood mononucleated cells: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance."
216345|NCT01503749|B2|Baseline|G-colony Stimulating Factor|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm.~G-colony stimulating factor: G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm."
216346|NCT01503749|B1|Baseline|Control|Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells
216347|NCT01503749|P3|Participant Flow|Infusion of the Mobilized Peripheral Blood Mononucleated Cells|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells~. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.~Infusion of the mobilized peripheral blood mononucleated cells: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance."
216348|NCT01503749|P2|Participant Flow|G-colony Stimulating Factor|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm.~G-colony stimulating factor: G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm."
216349|NCT01503749|P1|Participant Flow|Control|Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells
216350|NCT01503749|O3|Outcome|Infusion of the Mobilized Peripheral Blood Mononucleated Cells|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells~. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.~Infusion of the mobilized peripheral blood mononucleated cells: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance."
216351|NCT01503749|O2|Outcome|G-colony Stimulating Factor|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm.~G-colony stimulating factor: G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm."
216352|NCT01503749|O1|Outcome|Control|Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells
216353|NCT01503749|O3|Outcome|Infusion of the Mobilized Peripheral Blood Mononucleated Cells|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells~. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.~Infusion of the mobilized peripheral blood mononucleated cells: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance."
216354|NCT01503749|O2|Outcome|G-colony Stimulating Factor|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm.~G-colony stimulating factor: G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm."
216356|NCT01503749|E3|Reported Event|Infusion of the Mobilized Peripheral Blood Mononucleated Cells|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells~. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.~Infusion of the mobilized peripheral blood mononucleated cells: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance."
216357|NCT01503749|E2|Reported Event|G-colony Stimulating Factor|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm.~G-colony stimulating factor: G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm."
216358|NCT01503749|E1|Reported Event|Control|Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells
216359|NCT01503164|B3|Baseline|Total|Total of all reporting groups
216360|NCT01503164|B2|Baseline|Lifestyle Counseling|"Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.~LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan."
216361|NCT01503164|B1|Baseline|Positive Pressure Therapy (PAP)|"Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.~Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep."
216362|NCT01503164|P2|Participant Flow|Lifestyle Counseling|LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan.
216363|NCT01503164|P1|Participant Flow|Positive Pressure Therapy (PAP)|"Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.~Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep."
216364|NCT01503164|O2|Outcome|Lifestyle Counseling|"Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.~LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan."
216365|NCT01503164|O1|Outcome|Positive Pressure Therapy (PAP)|"Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.~Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep."
216366|NCT01503164|O2|Outcome|Lifestyle Counseling|"Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.~LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan."
216367|NCT01503164|O1|Outcome|Positive Pressure Therapy (PAP)|"Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.~Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep."
216368|NCT01503164|O2|Outcome|Lifestyle Counseling|"Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.~LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan."
216369|NCT01503164|O1|Outcome|Positive Pressure Therapy (PAP)|"Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.~Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep."
216370|NCT01503164|O2|Outcome|Lifestyle Counseling|"Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.~LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan."
216371|NCT01503164|O1|Outcome|Positive Pressure Therapy (PAP)|"Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.~Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep."
216372|NCT01503164|O2|Outcome|Lifestyle Counseling|"Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.~LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan."
216486|NCT01502761|O1|Outcome|Regional Intra-arterial Magnesium 0.75g|"Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients~Magnesium Sulfate: Intra-arterial"
216373|NCT01503164|O1|Outcome|Positive Pressure Therapy (PAP)|"Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.~Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep."
216374|NCT01503164|O2|Outcome|Lifestyle Counseling|"Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.~LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan."
216375|NCT01503164|O1|Outcome|Positive Pressure Therapy (PAP)|"Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.~Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep."
216376|NCT01503164|O2|Outcome|Lifestyle Counseling|"Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.~LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan."
216377|NCT01503164|O1|Outcome|Positive Pressure Therapy (PAP)|"Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.~Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep."
216378|NCT01503164|O2|Outcome|Lifestyle Counseling|"Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.~LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan."
216379|NCT01503164|O1|Outcome|Positive Pressure Therapy (PAP)|"Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.~Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep."
216380|NCT01503164|O2|Outcome|Lifestyle Counseling|"Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.~LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan."
216381|NCT01503164|O1|Outcome|Positive Pressure Therapy (PAP)|"Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.~Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep."
216382|NCT01503164|O2|Outcome|Lifestyle Counseling|"Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.~LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan."
216383|NCT01503164|O1|Outcome|Positive Pressure Therapy (PAP)|"Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.~Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep."
216384|NCT01503164|O2|Outcome|Lifestyle Counseling|"Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.~LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan."
216385|NCT01503164|O1|Outcome|Positive Pressure Therapy (PAP)|"Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.~Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep."
216386|NCT01503164|O2|Outcome|Lifestyle Counseling|"Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.~LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan."
216387|NCT01503164|O1|Outcome|Positive Pressure Therapy (PAP)|"Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.~Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep."
216388|NCT01503164|E2|Reported Event|Lifestyle Counseling|"Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.~LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan."
216792|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216389|NCT01503164|E1|Reported Event|Positive Pressure Therapy (PAP)|"Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.~Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep."
216390|NCT01503021|B3|Baseline|Total|Total of all reporting groups
216391|NCT01503021|B2|Baseline|Placebo/SFP|Standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µM (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks.
216392|NCT01503021|B1|Baseline|SFP/Placebo|Soluble ferric pyrophosphate (SFP) 2 µM (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks, then 1 week washout, then standard liquid bicarbonate concentrate without SFP x 2 weeks
216393|NCT01503021|P2|Participant Flow|Placebo/SFP|Standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks.
216394|NCT01503021|P1|Participant Flow|SFP/Placebo|Soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks, then 1 week washout, then standard liquid bicarbonate concentrate without SFP x 2 weeks
216395|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
216396|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
216397|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
216398|NCT01503021|O1|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
216399|NCT01503021|O1|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
216400|NCT01503021|O1|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
216401|NCT01503021|O2|Outcome|Placebo/SFP|"Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
216402|NCT01503021|O1|Outcome|SFP/Placebo|"Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
216403|NCT01503021|O2|Outcome|Placebo/SFP|"Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
216404|NCT01503021|O1|Outcome|SFP/Placebo|"Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
216405|NCT01503021|O2|Outcome|Placebo/SFP|"Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
216406|NCT01503021|O1|Outcome|SFP/Placebo|"Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
216407|NCT01503021|O2|Outcome|Placebo/SFP|"Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
216408|NCT01503021|O1|Outcome|SFP/Placebo|"Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
216409|NCT01503021|O2|Outcome|Placebo/SFP|"Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
216441|NCT01502956|B2|Baseline|Botox® Injection|Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
216410|NCT01503021|O1|Outcome|SFP/Placebo|"Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
216411|NCT01503021|O2|Outcome|Placebo/SFP|"Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
216412|NCT01503021|O1|Outcome|SFP/Placebo|"Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
216413|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
216414|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
216415|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
216416|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
216417|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
216418|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
216419|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
216420|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
216421|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
216422|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
216423|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
216424|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
216425|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
216426|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
216427|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
216428|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
216429|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
216430|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
216431|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
216432|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
216433|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
216434|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
216435|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
216436|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
216437|NCT01503021|E3|Reported Event|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
216438|NCT01503021|E2|Reported Event|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
216439|NCT01503021|E1|Reported Event|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
216440|NCT01502956|B3|Baseline|Total|Total of all reporting groups
216479|NCT01502761|P4|Participant Flow|Regional/ Distal (50/50%) Magnesium 1.5g|"Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients~Magnesium Sulfate: Intra-arterial"
216442|NCT01502956|B1|Baseline|InterStim® Device|The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
216443|NCT01502956|P2|Participant Flow|Botox® Injection|"Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.~Botox® injection: Eligible subjects will complete baseline assessments, be randomized and scheduled for Botox A® injection visit. Subjects who received a Botox A® injection will be assessed for a clinical response, at 1 month from injection, using the same clinical criterion (≥50% improvement in the mean number of UUIE/day on a 3 day bladder diary completed prior to the 1 month visit). Those subjects that experience a clinical response, at one month, will be eligible for a repeat Botox A® injection after 6 months, if they experience degradation of clinical effect, using the PGSC."
216444|NCT01502956|P1|Participant Flow|InterStim® Device|"The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.~InterStim® device: Eligible subjects will complete baseline assessments, be randomized and scheduled for first stage lead placement (FSLP) InterStim®. The criterion for an initial clinical response to InterStim® therapy will be d"
216445|NCT01502956|O2|Outcome|Botox® Injection|Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
216446|NCT01502956|O1|Outcome|InterStim® Device|The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
216447|NCT01502956|O2|Outcome|Botox® Injection|Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
216448|NCT01502956|O1|Outcome|InterStim® Device|The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
216449|NCT01502956|O2|Outcome|Botox® Injection|Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
216450|NCT01502956|O1|Outcome|InterStim® Device|The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
216451|NCT01502956|O2|Outcome|Botox® Injection|Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
216480|NCT01502761|P3|Participant Flow|Regional/ Distal (75/25%) Magnesium 1.5g|"Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients~Magnesium Sulfate: Intra-arterial"
216481|NCT01502761|P2|Participant Flow|Regional Intra-arterial Magnesium 1.5g|"Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients~Magnesium Sulfate: Intra-arterial"
216482|NCT01502761|P1|Participant Flow|Regional Intra-arterial Magnesium 0.75g|"Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients~Magnesium Sulfate: Intra-arterial"
216483|NCT01502761|O4|Outcome|Regional/ Distal (50/50%) Magnesium 1.5g|"Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients~Magnesium Sulfate: Intra-arterial"
216452|NCT01502956|O1|Outcome|InterStim® Device|The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
216453|NCT01502956|O2|Outcome|Botox® Injection|Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
216454|NCT01502956|O1|Outcome|InterStim® Device|The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
216455|NCT01502956|O2|Outcome|Botox® Injection|Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
216456|NCT01502956|O1|Outcome|InterStim® Device|The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
216457|NCT01502956|O2|Outcome|Botox® Injection|Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
216458|NCT01502956|O1|Outcome|InterStim® Device|The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
216459|NCT01502956|O2|Outcome|Botox® Injection|Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
216460|NCT01502956|O1|Outcome|InterStim® Device|The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
216461|NCT01502956|O2|Outcome|Botox® Injection|Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
216462|NCT01502956|O1|Outcome|InterStim® Device|The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
216463|NCT01502956|O2|Outcome|Botox® Injection|Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
216484|NCT01502761|O3|Outcome|Regional/ Distal (75/25%) Magnesium 1.5g|"Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients~Magnesium Sulfate: Intra-arterial"
216464|NCT01502956|O1|Outcome|InterStim® Device|The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
216465|NCT01502956|E2|Reported Event|Botox® Injection|Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
216466|NCT01502956|E1|Reported Event|InterStim® Device|The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
216467|NCT01502787|B1|Baseline|All Participants|The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period , there will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
216468|NCT01502787|P2|Participant Flow|Nebivolol First, Then Metoprolol|The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
216469|NCT01502787|P1|Participant Flow|Metoprolol First Then Nebivolol|"The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.~Metoprolol succinate: The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued."
216470|NCT01502787|O2|Outcome|Second Intervention Nebivolol: 24 Weeks|The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks.
216471|NCT01502787|O1|Outcome|First Intervention Metoprolol: 12 Weeks|The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks.
216472|NCT01502787|E2|Reported Event|Nebivolol 21 Subjects|The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
216473|NCT01502787|E1|Reported Event|Metoprolol 21 Subjects|The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks.
216474|NCT01502761|B5|Baseline|Total|Total of all reporting groups
216475|NCT01502761|B4|Baseline|Regional/ Distal (50/50%) Magnesium 1.5g|"Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients~Magnesium Sulfate: Intra-arterial"
216476|NCT01502761|B3|Baseline|Regional/ Distal (75/25%) Magnesium 1.5g|"Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients~Magnesium Sulfate: Intra-arterial"
216477|NCT01502761|B2|Baseline|Regional Intra-arterial Magnesium 1.5g|"Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients~Magnesium Sulfate: Intra-arterial"
216478|NCT01502761|B1|Baseline|Regional Intra-arterial Magnesium 0.75g|"Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients~Magnesium Sulfate: Intra-arterial"
216487|NCT01502761|O4|Outcome|Regional/ Distal (50/50%) Magnesium 1.5g|"Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients~Magnesium Sulfate: Intra-arterial"
216488|NCT01502761|O3|Outcome|Regional/ Distal (75/25%) Magnesium 1.5g|"Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients~Magnesium Sulfate: Intra-arterial"
216489|NCT01502761|O2|Outcome|Regional Intra-arterial Magnesium 1.5g|"Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients~Magnesium Sulfate: Intra-arterial"
216490|NCT01502761|O1|Outcome|Regional Intra-arterial Magnesium 0.75g|"Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients~Magnesium Sulfate: Intra-arterial"
216491|NCT01502761|E4|Reported Event|Regional/ Distal (50/50%) Magnesium 1.5g|"Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients~Magnesium Sulfate: Intra-arterial"
216492|NCT01502761|E3|Reported Event|Regional/ Distal (75/25%) Magnesium 1.5g|"Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients~Magnesium Sulfate: Intra-arterial"
216493|NCT01502761|E2|Reported Event|Regional Intra-arterial Magnesium 1.5g|"Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients~Magnesium Sulfate: Intra-arterial"
216494|NCT01502761|E1|Reported Event|Regional Intra-arterial Magnesium 0.75g|"Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients~Magnesium Sulfate: Intra-arterial"
216495|NCT01502709|B3|Baseline|Total|Total of all reporting groups
216496|NCT01502709|B2|Baseline|Placebo Arm|0 participants received placebo
216497|NCT01502709|B1|Baseline|Caloric Vestibular Neurostimulation|1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
216498|NCT01502709|P2|Participant Flow|Placebo Arm|0 participants received placebo
216499|NCT01502709|P1|Participant Flow|Caloric Vestibular Neurostimulation|1 treatment of caloric vestibular neurostimulation for 7.5 minutes in the right ear
216500|NCT01502709|O2|Outcome|Placebo Arm|0 participants received placebo
216501|NCT01502709|O1|Outcome|Caloric Vestibular Neurostimulation|1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
216502|NCT01502709|O2|Outcome|Placebo Arm|0 participants received placebo
216503|NCT01502709|O1|Outcome|Caloric Vestibular Neurostimulation|1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
216504|NCT01502709|O2|Outcome|Placebo Arm|0 participants received placebo
216505|NCT01502709|O1|Outcome|Neurostimulator|1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
216506|NCT01502709|E2|Reported Event|Placebo Arm|0 participants received placebo
216507|NCT01502709|E1|Reported Event|Caloric Vestibular Neurostimulation|1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
216508|NCT01502644|B4|Baseline|Total|Total of all reporting groups
216509|NCT01502644|B3|Baseline|High NA|Participants with high NA (HADS score ≥9 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
216510|NCT01502644|B2|Baseline|Moderate NA|Participants with moderate NA (HADS score ≥6 to ≤8 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
216511|NCT01502644|B1|Baseline|Low NA|Participants with low NA (HADS score ≤5 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
216512|NCT01502644|P4|Participant Flow|High NA|Participants with high NA (HADS score ≥9 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
216513|NCT01502644|P3|Participant Flow|Moderate NA|Participants with moderate NA (HADS score ≥6 to ≤8 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
216514|NCT01502644|P2|Participant Flow|Low NA|Participants with low NA (HADS score ≤5 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
216515|NCT01502644|P1|Participant Flow|Enrolled at Visit 1|All participants who satisfied pre-screening requirements and were enrolled at Visit 1.
216562|NCT01502371|B2|Baseline|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
216563|NCT01502371|B1|Baseline|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
216516|NCT01502644|O3|Outcome|High NA|Participants with high NA (HADS score ≥9 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
216517|NCT01502644|O2|Outcome|Moderate NA|Participants with moderate NA (HADS score ≥6 to ≤8 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
216518|NCT01502644|O1|Outcome|Low NA|Participants with low NA (HADS score ≤5 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
216519|NCT01502644|E3|Reported Event|High NA|Participants with high NA (HADS score ≥9 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
216520|NCT01502644|E2|Reported Event|Moderate NA|Participants with moderate NA (HADS score ≥6 to ≤8 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
216521|NCT01502644|E1|Reported Event|Low NA|Participants with low NA (HADS score ≤5 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
216522|NCT01502423|B3|Baseline|Total|Total of all reporting groups
216523|NCT01502423|B2|Baseline|New Formulation of Adalimumab/Current Formulation Adalimumab|First dose with 40 mg of new formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of current formulation of adalimumab in a pre-filled syringe.
216524|NCT01502423|B1|Baseline|Current Formulation Adalimumab/New Formulation of Adalimumab|First dose with 40 mg of current formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of new formulation of adalimumab in a pre-filled syringe.
216525|NCT01502423|P2|Participant Flow|New Formulation of Adalimumab/Current Formulation Adalimumab|First dose with 40 mg of new formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of current formulation of adalimumab in a pre-filled syringe.
216526|NCT01502423|P1|Participant Flow|Current Formulation Adalimumab/New Formulation of Adalimumab|First dose with 40 mg of current formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of new formulation of adalimumab in a pre-filled syringe.
216527|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
216528|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
216529|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
216530|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
216531|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
216532|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
216533|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
216534|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
216535|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
216536|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
216537|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
216538|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
216539|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
216540|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
216541|NCT01502423|E2|Reported Event|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
216542|NCT01502423|E1|Reported Event|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
216543|NCT01502410|B5|Baseline|Total|Total of all reporting groups
216544|NCT01502410|B4|Baseline|Group 4 Papillary Thyroid Carcinoma|"Patients with relapsed or refractory papillary thyroid carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
216545|NCT01502410|B3|Baseline|Group 3 Relapsed/Refractory Hepatocellular Carcinoma|"Patients with relapsed or refractory hepatocellular carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
216546|NCT01502410|B2|Baseline|Group 2 Relapsed/Refractory Wilms Tumor|"Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
216547|NCT01502410|B1|Baseline|Group 1 Relapsed/Refractory Rhabdomyosarcoma|"Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
216548|NCT01502410|P4|Participant Flow|Group 4 Papillary Thyroid Carcinoma|"Patients with relapsed or refractory papillary thyroid carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
216549|NCT01502410|P3|Participant Flow|Group 3 Relapsed/Refractory Hepatocellular Carcinoma|"Patients with relapsed or refractory hepatocellular carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
216550|NCT01502410|P2|Participant Flow|Group 2 Relapsed/Refractory Wilms Tumor|"Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
216551|NCT01502410|P1|Participant Flow|Group 1 Relapsed/Refractory Rhabdomyosarcoma|"Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
216552|NCT01502410|O4|Outcome|Group 4 Papillary Thyroid Carcinoma|"Patients with relapsed or refractory papillary thyroid carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
216553|NCT01502410|O3|Outcome|Group 3 Relapsed/Refractory Hepatocellular Carcinoma|"Patients with relapsed or refractory hepatocellular carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
216554|NCT01502410|O2|Outcome|Group 2 Relapsed/Refractory Wilms Tumor|"Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
216555|NCT01502410|O1|Outcome|Group 1 Relapsed/Refractory Rhabdomyosarcoma|"Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
216556|NCT01502410|E2|Reported Event|Group 2 Relapsed/Refractory Wilms Tumor|Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
216557|NCT01502410|E1|Reported Event|Group 1 Relapsed/Refractory Rhabdomyosarcoma|Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
216558|NCT01502371|B6|Baseline|Total|Total of all reporting groups
216559|NCT01502371|B5|Baseline|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
216560|NCT01502371|B4|Baseline|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
216561|NCT01502371|B3|Baseline|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
216793|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216566|NCT01502371|P3|Participant Flow|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
216567|NCT01502371|P2|Participant Flow|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
216568|NCT01502371|P1|Participant Flow|MF MDI 50 mcg BID|Participants receive mometasone furoate (MF) metered dose inhaler (MDI) 25 mcg x 2 inhalations (50 mcg total dose) twice daily (BID) PLUS Placebo dry powder inhaler (DPI) x 1 inhalation once daily (QD) in the evening for 12 weeks.
216569|NCT01502371|O2|Outcome|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
216570|NCT01502371|O1|Outcome|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
216571|NCT01502371|O5|Outcome|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
216572|NCT01502371|O4|Outcome|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
216573|NCT01502371|O3|Outcome|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
216574|NCT01502371|O2|Outcome|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
216575|NCT01502371|O1|Outcome|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
216576|NCT01502371|O5|Outcome|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
216577|NCT01502371|O4|Outcome|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
216578|NCT01502371|O3|Outcome|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
216579|NCT01502371|O2|Outcome|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
216580|NCT01502371|O1|Outcome|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
216581|NCT01502371|O4|Outcome|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
216582|NCT01502371|O3|Outcome|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
216583|NCT01502371|O2|Outcome|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
216584|NCT01502371|O1|Outcome|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
216585|NCT01502371|E5|Reported Event|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
216586|NCT01502371|E4|Reported Event|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
216587|NCT01502371|E3|Reported Event|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
216588|NCT01502371|E2|Reported Event|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
216589|NCT01502371|E1|Reported Event|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
216590|NCT01502332|B3|Baseline|Total|Total of all reporting groups
216591|NCT01502332|B2|Baseline|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
216592|NCT01502332|B1|Baseline|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
216593|NCT01502332|P2|Participant Flow|Moderate Alveolar Recruitment|Moderate alveolar recruitment ARM: recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
216594|NCT01502332|P1|Participant Flow|Intensive Alveolar Recruitment|Intensive Alveolar Recruitment ARM: recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
216595|NCT01502332|O2|Outcome|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
216596|NCT01502332|O1|Outcome|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
216597|NCT01502332|O2|Outcome|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
216598|NCT01502332|O1|Outcome|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
216599|NCT01502332|O2|Outcome|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
216600|NCT01502332|O1|Outcome|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
216601|NCT01502332|O2|Outcome|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
216602|NCT01502332|O1|Outcome|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
216603|NCT01502332|O2|Outcome|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
216604|NCT01502332|O1|Outcome|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
216605|NCT01502332|E2|Reported Event|Moderate Alveolar Recruitment ARM|Mechanical ventilation strategy: Moderate alveolar recruitment ARM: recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
216606|NCT01502332|E1|Reported Event|Intensive Alveolar Recruitment ARM|Mechanical ventilation strategy: Intensive Alveolar Recruitment ARM: recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
216607|NCT01502228|B1|Baseline|62Cu-ETS PET Assessment|"CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection 150-Water: Patients will be imaged immediately before, and between 14-28 days after initiation of Sunitinib therapy, in the single bed position using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 15O-water at 50 mCi/dose, IV.~62Cu-ethylglyoxal bis: Imaging with 62Cu-ETS will be done immediately following imaging with 150-water. Patients will be imaged immediately before, and between 14-28 days after, initiation of Sunitinib therapy using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 62Cu-ETS in the range of 20-25 mCi/Dose, IV. Positron Emission Tomography: PET Scan Sunitinib"
216608|NCT01502228|P1|Participant Flow|62Cu-ETS PET Assessment|"CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection 150-Water: Patients will be imaged immediately before, and between 14-28 days after initiation of Sunitinib therapy, in the single bed position using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 15O-water at 50 mCi/dose, IV.~62Cu-ethylglyoxal bis: Imaging with 62Cu-ETS will be done immediately following imaging with 150-water. Patients will be imaged immediately before, and between 14-28 days after, initiation of Sunitinib therapy using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 62Cu-ETS in the range of 20-25 mCi/Dose, IV. Positron Emission Tomography: PET Scan Sunitinib"
216609|NCT01502228|O1|Outcome|62Cu-ETS PET Assessment|"CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection 150-Water: Patients will be imaged immediately before, and between 14-28 days after initiation of Sunitinib therapy, in the single bed position using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 15O-water at 50 mCi/dose, IV.~62Cu-ethylglyoxal bis: Imaging with 62Cu-ETS will be done immediately following imaging with 150-water. Patients will be imaged immediately before, and between 14-28 days after, initiation of Sunitinib therapy using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 62Cu-ETS in the range of 20-25 mCi/Dose, IV. Positron Emission Tomography: PET Scan Sunitinib"
216610|NCT01502228|O1|Outcome|62Cu-ETS PET Assessment|"CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection 150-Water: Patients will be imaged immediately before, and between 14-28 days after initiation of Sunitinib therapy, in the single bed position using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 15O-water at 50 mCi/dose, IV.~62Cu-ethylglyoxal bis: Imaging with 62Cu-ETS will be done immediately following imaging with 150-water. Patients will be imaged immediately before, and between 14-28 days after, initiation of Sunitinib therapy using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 62Cu-ETS in the range of 20-25 mCi/Dose, IV. Positron Emission Tomography: PET Scan Sunitinib"
216611|NCT01502228|E1|Reported Event|62Cu-ETS PET Assessment|"CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection 150-Water: Patients will be imaged immediately before, and between 14-28 days after initiation of Sunitinib therapy, in the single bed position using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 15O-water at 50 mCi/dose, IV.~62Cu-ethylglyoxal bis: Imaging with 62Cu-ETS will be done immediately following imaging with 150-water. Patients will be imaged immediately before, and between 14-28 days after, initiation of Sunitinib therapy using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 62Cu-ETS in the range of 20-25 mCi/Dose, IV. Positron Emission Tomography: PET Scan Sunitinib"
216612|NCT01502033|B1|Baseline|Transcranial Magnetic Stimulation|"Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.~Transcranial Magnetic Stimulation"
216613|NCT01502033|P1|Participant Flow|Transcranial Magnetic Stimulation|"Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.~Transcranial Magnetic Stimulation"
216614|NCT01502033|O1|Outcome|Transcranial Magnetic Stimulation|"Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.~Transcranial Magnetic Stimulation: 30 daily treatments of (over 6-8 weeks) of 10 Hz rTMS at 120% motor threshold, applied to the left dorsolateral prefrontal cortex with 3,000 stimulations per treatment"
216615|NCT01502033|O1|Outcome|Open Label Active Treatment|All participants had unblended treatment
216616|NCT01502033|O1|Outcome|Transcranial Magnetic Stimulation|"Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.~Transcranial Magnetic Stimulation"
216617|NCT01502033|E1|Reported Event|Open Label Active Treatment|All participants had unblinded treatment
216618|NCT01501162|B3|Baseline|Total|Total of all reporting groups
216619|NCT01501162|B2|Baseline|Hepatitis, Alcohol, Probiotics|7 days of probiotics (1500 mg/day)
216620|NCT01501162|B1|Baseline|Alcohol, Hepatitis, Placebo|Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
216621|NCT01501162|P2|Participant Flow|Hepatitis, Alcohol, Probiotics|7 days of probiotics (1500 mg/day)
216622|NCT01501162|P1|Participant Flow|Alcohol, Hepatitis, Placebo|Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
216623|NCT01501162|O2|Outcome|Hepatitis, Alcohol, Probiotics|7 days of probiotics (1500 mg/day)
216624|NCT01501162|O1|Outcome|Alcohol, Hepatitis, Placebo|Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
216625|NCT01501162|O2|Outcome|Hepatitis, Alcohol, Probiotics|7 days of probiotics (1500 mg/day)
216626|NCT01501162|O1|Outcome|Alcohol, Hepatitis, Placebo|Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
216627|NCT01501162|E2|Reported Event|Hepatitis, Alcohol, Probiotics|7 days of probiotics (1500 mg/day)
216628|NCT01501162|E1|Reported Event|Alcohol, Hepatitis, Placebo|Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
216629|NCT01501110|B3|Baseline|Total|Total of all reporting groups
216630|NCT01501110|B2|Baseline|no Intervention|No intervention / usual care
216631|NCT01501110|B1|Baseline|N-acetylcysteine|"intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours.~N-acetylcysteine: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours"
216632|NCT01501110|P2|Participant Flow|no Intervention|No intervention / usual care
216633|NCT01501110|P1|Participant Flow|N-acetylcysteine|"intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours.~N-acetylcysteine: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours"
216634|NCT01501110|O2|Outcome|no Intervention|No intervention / usual care
216635|NCT01501110|O1|Outcome|N-acetylcysteine|"intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours.~N-acetylcysteine: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours"
216636|NCT01501110|E2|Reported Event|no Intervention|No intervention / usual care
216637|NCT01501110|E1|Reported Event|N-acetylcysteine|"intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours.~N-acetylcysteine: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours"
216638|NCT01500772|B1|Baseline|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
216639|NCT01500772|P1|Participant Flow|Alisporivir|Alisporivir (ALV) 400 mg twice daily (BID), with peginterferon alfa-2a (PEG) and ribavirin (RBV) for 48 weeks.
216640|NCT01500772|O1|Outcome|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
216641|NCT01500772|O1|Outcome|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
216642|NCT01500772|O1|Outcome|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
216643|NCT01500772|O1|Outcome|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
216644|NCT01500772|E1|Reported Event|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
216645|NCT01500746|B3|Baseline|Total|Total of all reporting groups
216646|NCT01500746|B2|Baseline|Moist Dressings|"This group will serve as the control group. They will undergo twice daily dressing changes with moist gauze dressings for a total of 4 days (8 dressing changes). Bacterial counts and gene expression analysis will be performed prior to the first dressing change and after the last dressing change.~Dressing changes: Wounds will be treated with moist gauze dressing changes twice daily for a total of 4 days (8 treatments)."
216647|NCT01500746|B1|Baseline|Lavage Arm|"This group will serve as the experimental arm. They will undergo twice daily pulse lavage of their wounds for 4 days. In between the lavage treatments, their wounds will be dressed with moist gauze.~Pulse lavage treatment: A pulse lavage machine will be used to irrigate the wound with a total of 4 liters of water, twice daily, for a total of 4 days (8 treatments)."
216648|NCT01500746|P2|Participant Flow|Moist Dressings|This group will serve as the control group. They will undergo twice daily dressing changes with moist gauze dressings for a total of 4 days (8 dressing changes). Bacterial counts and gene expression analysis will be performed prior to the first dressing change and after the last dressing change.
216649|NCT01500746|P1|Participant Flow|Lavage Arm|This group will serve as the experimental arm. They will undergo twice daily pulse lavage of their wounds for 4 days. In between the lavage treatments, their wounds will be dressed with moist gauze.
216650|NCT01500746|O2|Outcome|Moist Dressings|This group will serve as the control group. They will undergo twice daily dressing changes with moist gauze dressings for a total of 4 days (8 dressing changes). Bacterial counts and gene expression analysis will be performed prior to the first dressing change and after the last dressing change.
216651|NCT01500746|O1|Outcome|Lavage Arm|This group will serve as the experimental arm. They will undergo twice daily pulse lavage of their wounds for 4 days. In between the lavage treatments, their wounds will be dressed with moist gauze.
216794|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216795|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216652|NCT01500746|E2|Reported Event|Moist Dressings|"This group will serve as the control group. They will undergo twice daily dressing changes with moist gauze dressings for a total of 4 days (8 dressing changes). Bacterial counts and gene expression analysis will be performed prior to the first dressing change and after the last dressing change.~Dressing changes: Wounds will be treated with moist gauze dressing changes twice daily for a total of 4 days (8 treatments)."
216653|NCT01500746|E1|Reported Event|Lavage Arm|"This group will serve as the experimental arm. They will undergo twice daily pulse lavage of their wounds for 4 days. In between the lavage treatments, their wounds will be dressed with moist gauze.~Pulse lavage treatment: A pulse lavage machine will be used to irrigate the wound with a total of 4 liters of water, twice daily, for a total of 4 days (8 treatments)."
216654|NCT01500720|B3|Baseline|Total|Total of all reporting groups
216655|NCT01500720|B2|Baseline|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
216656|NCT01500720|B1|Baseline|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
216657|NCT01500720|P2|Participant Flow|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
216658|NCT01500720|P1|Participant Flow|Cabazitaxel|Cabazitaxel (XRP6258) 25 milligram per square meter (mg/m^2) intravenously (IV) on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
216659|NCT01500720|O2|Outcome|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
216660|NCT01500720|O1|Outcome|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
216661|NCT01500720|O2|Outcome|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
216662|NCT01500720|O1|Outcome|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
216663|NCT01500720|O2|Outcome|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
216664|NCT01500720|O1|Outcome|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
216665|NCT01500720|O2|Outcome|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
216666|NCT01500720|O1|Outcome|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
216667|NCT01500720|E2|Reported Event|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
216668|NCT01500720|E1|Reported Event|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
216669|NCT01500694|B3|Baseline|Total|Total of all reporting groups
216670|NCT01500694|B2|Baseline|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
216671|NCT01500694|B1|Baseline|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
216672|NCT01500694|P2|Participant Flow|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
216673|NCT01500694|P1|Participant Flow|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 milligram [mg] or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
216674|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
216675|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
216676|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
216677|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
216678|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
216679|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
216680|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
216681|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
216796|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216682|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
216683|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
216684|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
216685|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
216686|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
216687|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
216688|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
216689|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
216690|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
216691|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
216692|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
216693|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
216694|NCT01500694|E2|Reported Event|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
216695|NCT01500694|E1|Reported Event|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
216696|NCT01500629|B3|Baseline|Total|Total of all reporting groups
216697|NCT01500629|B2|Baseline|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216698|NCT01500629|B1|Baseline|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216699|NCT01500629|P2|Participant Flow|Placebo Then C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
216700|NCT01500629|P1|Participant Flow|C-1266-7 Then Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
216701|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216797|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216798|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216702|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216703|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216704|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216705|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216706|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216707|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216708|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216709|NCT01500629|O2|Outcome|C-1266-6 Then C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216710|NCT01500629|O1|Outcome|C-1266-7 Then C-1266-6|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216711|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216712|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216713|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216714|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216715|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216716|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216717|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216718|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216719|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216720|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216721|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216722|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216723|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216724|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216725|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216913|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
216726|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216727|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216728|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216729|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216730|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216731|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216732|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216733|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216734|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216735|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216736|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216737|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216914|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
216738|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216739|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216740|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216741|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216742|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216743|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216744|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216745|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216746|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216747|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216748|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216749|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216915|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
216750|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216751|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216752|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216753|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216754|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216755|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216756|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216757|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216758|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216759|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216760|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216761|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216916|NCT01500252|E2|Reported Event|Patellar Retention|Subjects retained their native patella.
216762|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216763|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216764|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216765|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216766|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216767|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
216768|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
216769|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
216770|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
216771|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
216772|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
216799|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216800|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216801|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216802|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216773|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
216774|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
216775|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo).. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo).: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
216776|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
216777|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6, (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
216778|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
216779|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
216780|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
216781|NCT01500629|E2|Reported Event|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216782|NCT01500629|E1|Reported Event|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
216783|NCT01500434|B1|Baseline|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216784|NCT01500434|P1|Participant Flow|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216785|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216786|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216787|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216788|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216789|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216790|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216803|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216804|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216805|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216806|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216807|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216808|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216809|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216810|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216811|NCT01500434|E1|Reported Event|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
216812|NCT01500382|B5|Baseline|Total|Total of all reporting groups
216813|NCT01500382|B4|Baseline|Placebo → Vibegron 50 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 50 mg and placebo to match tolterodine ER.
216814|NCT01500382|B3|Baseline|Placebo → Tolterodine 4 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily tolterodine 4 mg and placebo to match vibegron.
216815|NCT01500382|B2|Baseline|Placebo → Vibegron 100 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 100 mg and placebo to match tolterodine ER.
216816|NCT01500382|B1|Baseline|Vibegron 100 mg + Tolterodine 4 mg → Placebo|During Treatment Period 1, participants received 7 days of once-daily vibegron 100 mg and tolterodine extended-release (ER) 4 mg. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER.
216817|NCT01500382|P4|Participant Flow|Placebo → Vibegron 50 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 50 mg and placebo to match tolterodine ER.
216818|NCT01500382|P3|Participant Flow|Placebo → Tolterodine 4 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily tolterodine 4 mg and placebo to match vibegron.
216819|NCT01500382|P2|Participant Flow|Placebo → Vibegron 100 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 100 mg and placebo to match tolterodine ER.
216820|NCT01500382|P1|Participant Flow|Vibegron 100 mg + Tolterodine 4 mg → Placebo|During Treatment Period 1, participants received 7 days of once-daily vibegron 100 mg and tolterodine extended-release (ER) 4 mg. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER.
216821|NCT01500382|O4|Outcome|Placebo|Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg.
216822|NCT01500382|O3|Outcome|Vibegron 50 mg|Participants received 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER 4 mg.
216823|NCT01500382|O2|Outcome|Vibegron 100 mg + Tolterodine ER 4 mg|Participants received 7 days of once-daily vibegron 100 mg and tolterodine ER 4 mg.
216824|NCT01500382|O1|Outcome|Vibegron 100 mg|Participants received 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER 4 mg.
216825|NCT01500382|O4|Outcome|Placebo|Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg.
216826|NCT01500382|O3|Outcome|Vibegron 50 mg|Participants received 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER 4 mg.
216827|NCT01500382|O2|Outcome|Vibegron 100 mg + Tolterodine ER 4 mg|Participants received 7 days of once-daily vibegron 100 mg and tolterodine ER 4 mg.
216828|NCT01500382|O1|Outcome|Vibegron 100 mg|Participants received 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER 4 mg.
216829|NCT01500382|O4|Outcome|Placebo|Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg.
216830|NCT01500382|O3|Outcome|Vibegron 50 mg|Participants received 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER 4 mg.
216831|NCT01500382|O2|Outcome|Vibegron 100 mg + Tolterodine ER 4 mg|Participants received 7 days of once-daily vibegron 100 mg and tolterodine ER 4 mg.
216832|NCT01500382|O1|Outcome|Vibegron 100 mg|Participants received 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER 4 mg.
216833|NCT01500382|O4|Outcome|Placebo|Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg.
216834|NCT01500382|O3|Outcome|Vibegron 50 mg|Participants received 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER 4 mg.
216835|NCT01500382|O2|Outcome|Vibegron 100 mg + Tolterodine ER 4 mg|Participants received 7 days of once-daily vibegron 100 mg and tolterodine ER 4 mg.
216836|NCT01500382|O1|Outcome|Vibegron 100 mg|Participants received 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER 4 mg.
216837|NCT01500382|E4|Reported Event|Placebo|Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg.
216838|NCT01500382|E3|Reported Event|Vibegron 50 mg|Participants received 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER 4 mg.
216839|NCT01500382|E2|Reported Event|Vibegron 100 mg + Tolterodine ER 4 mg|Participants received 7 days of once-daily vibegron 100 mg and tolterodine ER 4 mg.
216840|NCT01500382|E1|Reported Event|Vibegron 100 mg|Participants received 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER 4 mg.
216841|NCT01500317|B4|Baseline|Total|Total of all reporting groups
216842|NCT01500317|B3|Baseline|Placebo|Placebo tid
216843|NCT01500317|B2|Baseline|Oxycodone|5 mg oxycodone tid
216844|NCT01500317|B1|Baseline|Tapentadol|75 mg tapentadol tid
216845|NCT01500317|P3|Participant Flow|Placebo|Placebo tid
216846|NCT01500317|P2|Participant Flow|Oxycodone|5 mg oxycodone tid
216847|NCT01500317|P1|Participant Flow|Tapentadol|75 mg tapentadol tid
216848|NCT01500317|O3|Outcome|Placebo|Placebo tid
216849|NCT01500317|O2|Outcome|Oxycodone|5 mg oxycodone tid
216850|NCT01500317|O1|Outcome|Tapentadol|75 mg tapentadol tid
216851|NCT01500317|O3|Outcome|Placebo|Placebo tid
216852|NCT01500317|O2|Outcome|Oxycodone|5 mg oxycodone tid
216853|NCT01500317|O1|Outcome|Tapentadol|75 mg tapentadol tid
216854|NCT01500317|O3|Outcome|Placebo|Placebo tid
216855|NCT01500317|O2|Outcome|Oxycodone|5 mg oxycodone tid
216856|NCT01500317|O1|Outcome|Tapentadol|75 mg tapentadol tid
216857|NCT01500317|O3|Outcome|Placebo|Placebo tid
216858|NCT01500317|O2|Outcome|Oxycodone|5 mg oxycodone tid
216859|NCT01500317|O1|Outcome|Tapentadol|75 mg tapentadol tid
216860|NCT01500317|O3|Outcome|Placebo|Placebo tid
216861|NCT01500317|O2|Outcome|Oxycodone|5 mg oxycodone tid
216862|NCT01500317|O1|Outcome|Tapentadol|75 mg tapentadol tid
216863|NCT01500317|E3|Reported Event|Placebo|Placebo tid
216864|NCT01500317|E2|Reported Event|Oxycodone|5 mg oxycodone tid
216865|NCT01500317|E1|Reported Event|Tapentadol|75 mg tapentadol tid
216866|NCT01500278|B3|Baseline|Total Title|
216867|NCT01500278|B2|Baseline|ADA+MTX (RTG)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.~Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
216868|NCT01500278|B1|Baseline|CZP+MTX (RTG)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.~Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
216869|NCT01500278|P2|Participant Flow|ADA+MTX (RTG)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.~Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
216870|NCT01500278|P1|Participant Flow|CZP+MTX (RTG)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.~Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
216871|NCT01500278|O2|Outcome|ADA+MTX (Week 12 Responder Set)|"ADA 40 mg at Baseline and then every 2 Weeks until Week 102. Subjects received PBO in addition to ADA at baseline and weeks 2 and 4 in order to maintain the blinding.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
216872|NCT01500278|O1|Outcome|CZP+MTX (Week 12 Responder Set)|"CZP 400 mg at Baseline, Week 2 and Week 4, followed by a maintenance dose of 200 mg every 2 Weeks until Week 102.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
216906|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
216907|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
216873|NCT01500278|O2|Outcome|ADA+MTX (FAS)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.~Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
216874|NCT01500278|O1|Outcome|CZP+MTX (FAS)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.~Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
216875|NCT01500278|O2|Outcome|ADA+MTX (Week 12 Responder Set)|"ADA 40 mg at Baseline and then every 2 Weeks until Week 102. Subjects received PBO in addition to ADA at baseline and weeks 2 and 4 in order to maintain the blinding.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
216876|NCT01500278|O1|Outcome|CZP+MTX (Week 12 Responder Set)|"CZP 400 mg at Baseline, Week 2 and Week 4, followed by a maintenance dose of 200 mg every 2 Weeks until Week 102.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
216877|NCT01500278|O2|Outcome|ADA+MTX (FAS)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.~Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
216878|NCT01500278|O1|Outcome|CZP+MTX (FAS)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.~Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
216879|NCT01500278|O2|Outcome|ADA+MTX (FAS)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.~Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
216880|NCT01500278|O1|Outcome|CZP+MTX (FAS)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.~Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
216881|NCT01500278|O2|Outcome|ADA+MTX (FAS)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.~Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
216908|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
216882|NCT01500278|O1|Outcome|CZP+MTX (FAS)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.~Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
216883|NCT01500278|O2|Outcome|ADA+MTX (Week 12 Responder Set)|"ADA 40 mg at Baseline and then every 2 Weeks until Week 102. Subjects received PBO in addition to ADA at baseline and weeks 2 and 4 in order to maintain the blinding.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
216884|NCT01500278|O1|Outcome|CZP+MTX (Week 12 Responder Set)|"CZP 400 mg at Baseline, Week 2 and Week 4, followed by a maintenance dose of 200 mg every 2 Weeks until Week 102.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
216885|NCT01500278|O2|Outcome|ADA+MTX (FAS)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.~Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
216886|NCT01500278|O1|Outcome|CZP+MTX (FAS)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.~Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
216887|NCT01500278|O2|Outcome|ADA+MTX (FAS)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.~Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
216888|NCT01500278|O1|Outcome|CZP+MTX (FAS)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.~Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
216889|NCT01500278|E2|Reported Event|ADA+MTX (SS)|All subjects who received at least 1 dose of Adalimumab (ADA). All adverse events that occurred when the subject was receiving ADA treatment are summarized in this group.
216890|NCT01500278|E1|Reported Event|CZP+MTX (SS)|All subjects who received at least 1 dose of Certolizumab pegol (CZP). All adverse events that occurred when the subject was receiving CZP treatment are summarized in this group.
216891|NCT01500252|B3|Baseline|Total|Total of all reporting groups
216892|NCT01500252|B2|Baseline|Patellar Retention|Subjects retained their native patella.
216893|NCT01500252|B1|Baseline|Patellar Resurfacing|Subjects received patellar resurfacing.
216894|NCT01500252|P2|Participant Flow|Patellar Retention|Subjects retained their native patella.
216895|NCT01500252|P1|Participant Flow|Patellar Resurfacing|Subjects received patellar resurfacing.
216896|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
216897|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
216898|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
216899|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
216900|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
216901|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing
216902|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
216903|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
216904|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
216905|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
216917|NCT01500252|E1|Reported Event|Patellar Resurfacing|Subjects received patellar resurfacing.
216918|NCT01500226|B3|Baseline|Total|Total of all reporting groups
216919|NCT01500226|B2|Baseline|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
216920|NCT01500226|B1|Baseline|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
216921|NCT01500226|P2|Participant Flow|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
216922|NCT01500226|P1|Participant Flow|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy.~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy."
216923|NCT01500226|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
216924|NCT01500226|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
216925|NCT01500226|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
216926|NCT01500226|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
216927|NCT01500226|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
216928|NCT01500226|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
216929|NCT01500226|E2|Reported Event|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy~685 subjects were randomized to control~674 of those who were randomized to control received control in C1~Safety = 674 control"
216930|NCT01500226|E1|Reported Event|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy~684 subjects were randomized to Rolapitant~670 of those randomized to Rolapitant received rolapitant in C1~Safety = 670 Rolapitant"
216931|NCT01500213|B3|Baseline|Total|Total of all reporting groups
216932|NCT01500213|B2|Baseline|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
216933|NCT01500213|B1|Baseline|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
216934|NCT01500213|P2|Participant Flow|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
216935|NCT01500213|P1|Participant Flow|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
216936|NCT01500213|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
216937|NCT01500213|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
217231|NCT01499290|O3|Outcome|CAZ-AVI + Metronidazole (TOC)|TOC - 28 to 35 days after start of study drug
216938|NCT01500213|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
216939|NCT01500213|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
216940|NCT01500213|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
216941|NCT01500213|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
216942|NCT01500213|E2|Reported Event|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4~277 subjects were randomized to control;~274 of those who were randomized to control received control in C1.~Safety = 274 control"
216943|NCT01500213|E1|Reported Event|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4~278 subjects were randomized to Rolapitant~272 of those randomized to Rolapitant received Rolapitant in C1~Safety = 272 Rolapitant"
216944|NCT01500135|B3|Baseline|Total|Total of all reporting groups
216945|NCT01500135|B2|Baseline|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
216946|NCT01500135|B1|Baseline|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
216947|NCT01500135|P2|Participant Flow|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
216948|NCT01500135|P1|Participant Flow|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
216949|NCT01500135|O2|Outcome|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
216950|NCT01500135|O1|Outcome|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
216951|NCT01500135|O2|Outcome|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
216952|NCT01500135|O1|Outcome|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
216953|NCT01500135|O2|Outcome|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
216954|NCT01500135|O1|Outcome|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
216955|NCT01500135|E2|Reported Event|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
216956|NCT01500135|E1|Reported Event|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
216957|NCT01500109|B4|Baseline|Total|Total of all reporting groups
216987|NCT01500057|O1|Outcome|Greenlight XPS Laser|"Greenlight XPS Laser of the prostate~Greenlight XPS Laser: Treatment of BPH with Greenlight XPS laser"
216988|NCT01500057|O2|Outcome|BiVAP Saline Vaporization|"BiVAP Saline Vaporization of the prostate~BiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization"
216958|NCT01500109|B3|Baseline|Opioid Only|"This group will receive placebo oral cherry elixir prior to going to the operating room and placebo Ofirmev® after securing intravenous access in the operating room with redosing every six hours. They will receive local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to incision as well as at the completion of surgery with Bupivicaine 0.25% with Epinephrine. Postoperatively they will receive only Morphine prn for pain control.~Opioid only: Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed."
216959|NCT01500109|B2|Baseline|Oral Acetaminophen|"Patients will receive oral acetaminophen cherry elixir preoperatively. After intravenous access is obtained intraoperatively patients will receive placebo for Ofirmev (saline). Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to surgical incision as wel as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patient will receive oral acetaminophen every six hours and intravenous placebo (normal saline) for intravenous acetaminophen. Intravenous morphine will be administered as needed for 24 hours.~Oral acetaminophen: Oral acetaminophen administered as a cherry flavored elixir will be dosed preoperatively 15 mg/kg and redosed every 6 hours for 24 hours. Placebo oral acetaminophen will be administered to the other two arms of the study according to the same timetable. Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care t"
216960|NCT01500109|B1|Baseline|Ofirmev®|"Oral inert cherry syrup will be administered preoperatively as placebo for oral acetaminophen. Ofirmev will be administered in the operating room once intravenous access is established. Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon before surgical incision as well as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patients will receive Ofirmev® every 6 hours as well as placebo oral cherry elixir every 6 hours and morphine as needed for 24 hours.~Ofirmev®: Intravenous acetaminophen is initiated after intravenous access is obtained intraoperatively and before surgical incision. Dosing is age based as follows: 5 months-2 years 12.5 mg/kg, 2-5 years 15 mg/kg. Redosing will be every 6 hours for 24 hours. The two other arms will receive a placebo in the form of normal saline given intravenously. Intraoperative opioids will be administered as deemed necessary by anesthesia c"
216961|NCT01500109|P3|Participant Flow|Opioid Only|"This group will receive placebo oral cherry elixir prior to going to the operating room and placebo Ofirmev® after securing intravenous access in the operating room with redosing every six hours. They will receive local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to incision as well as at the completion of surgery with Bupivicaine 0.25% with Epinephrine. Postoperatively they will receive only Morphine prn for pain control.~Opioid only: Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed."
216962|NCT01500109|P2|Participant Flow|Oral Acetaminophen|"Patients will receive oral acetaminophen cherry elixir preoperatively. After intravenous access is obtained intraoperatively patients will receive placebo for Ofirmev (saline). Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to surgical incision as wel as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patient will receive oral acetaminophen every six hours and intravenous placebo (normal saline) for intravenous acetaminophen. Intravenous morphine will be administered as needed for 24 hours.~Oral acetaminophen: Oral acetaminophen administered as a cherry flavored elixir will be dosed preoperatively 15 mg/kg and redosed every 6 hours for 24 hours. Placebo oral acetaminophen will be administered to the other two arms of the study according to the same timetable. Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care t"
216963|NCT01500109|P1|Participant Flow|Ofirmev®|"Oral inert cherry syrup will be administered preoperatively as placebo for oral acetaminophen. Ofirmev will be administered in the operating room once intravenous access is established. Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon before surgical incision as well as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patients will receive Ofirmev® every 6 hours as well as placebo oral cherry elixir every 6 hours and morphine as needed for 24 hours.~Ofirmev®: Intravenous acetaminophen is initiated after intravenous access is obtained intraoperatively and before surgical incision. Dosing is age based as follows: 5 months-2 years 12.5 mg/kg, 2-5 years 15 mg/kg. Redosing will be every 6 hours for 24 hours. The two other arms will receive a placebo in the form of normal saline given intravenously. Intraoperative opioids will be administered as deemed necessary by anesthesia c"
216964|NCT01500109|O3|Outcome|Opioid Only|"This group will receive placebo oral cherry elixir prior to going to the operating room and placebo Ofirmev® after securing intravenous access in the operating room with redosing every six hours. They will receive local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to incision as well as at the completion of surgery with Bupivicaine 0.25% with Epinephrine. Postoperatively they will receive only Morphine prn for pain control.~Opioid only: Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed."
216965|NCT01500109|O2|Outcome|Oral Acetaminophen|"Patients will receive oral acetaminophen cherry elixir preoperatively. After intravenous access is obtained intraoperatively patients will receive placebo for Ofirmev (saline). Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to surgical incision as wel as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patient will receive oral acetaminophen every six hours and intravenous placebo (normal saline) for intravenous acetaminophen. Intravenous morphine will be administered as needed for 24 hours.~Oral acetaminophen: Oral acetaminophen administered as a cherry flavored elixir will be dosed preoperatively 15 mg/kg and redosed every 6 hours for 24 hours. Placebo oral acetaminophen will be administered to the other two arms of the study according to the same timetable. Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care t"
216989|NCT01500057|O1|Outcome|Greenlight XPS Laser|"Greenlight XPS Laser of the prostate~Greenlight XPS Laser: Treatment of BPH with Greenlight XPS laser"
216966|NCT01500109|O1|Outcome|Ofirmev®|"Oral inert cherry syrup will be administered preoperatively as placebo for oral acetaminophen. Ofirmev will be administered in the operating room once intravenous access is established. Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon before surgical incision as well as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patients will receive Ofirmev® every 6 hours as well as placebo oral cherry elixir every 6 hours and morphine as needed for 24 hours.~Ofirmev®: Intravenous acetaminophen is initiated after intravenous access is obtained intraoperatively and before surgical incision. Dosing is age based as follows: 5 months-2 years 12.5 mg/kg, 2-5 years 15 mg/kg. Redosing will be every 6 hours for 24 hours. The two other arms will receive a placebo in the form of normal saline given intravenously. Intraoperative opioids will be administered as deemed necessary by anesthesia c"
216967|NCT01500109|E3|Reported Event|Opioid Only|"This group will receive placebo oral cherry elixir prior to going to the operating room and placebo Ofirmev® after securing intravenous access in the operating room with redosing every six hours. They will receive local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to incision as well as at the completion of surgery with Bupivicaine 0.25% with Epinephrine. Postoperatively they will receive only Morphine prn for pain control.~Opioid only: Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed."
216968|NCT01500109|E2|Reported Event|Oral Acetaminophen|"Patients will receive oral acetaminophen cherry elixir preoperatively. After intravenous access is obtained intraoperatively patients will receive placebo for Ofirmev (saline). Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to surgical incision as wel as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patient will receive oral acetaminophen every six hours and intravenous placebo (normal saline) for intravenous acetaminophen. Intravenous morphine will be administered as needed for 24 hours.~Oral acetaminophen: Oral acetaminophen administered as a cherry flavored elixir will be dosed preoperatively 15 mg/kg and redosed every 6 hours for 24 hours. Placebo oral acetaminophen will be administered to the other two arms of the study according to the same timetable. Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care t"
216969|NCT01500109|E1|Reported Event|Ofirmev®|"Oral inert cherry syrup will be administered preoperatively as placebo for oral acetaminophen. Ofirmev will be administered in the operating room once intravenous access is established. Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon before surgical incision as well as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patients will receive Ofirmev® every 6 hours as well as placebo oral cherry elixir every 6 hours and morphine as needed for 24 hours.~Ofirmev®: Intravenous acetaminophen is initiated after intravenous access is obtained intraoperatively and before surgical incision. Dosing is age based as follows: 5 months-2 years 12.5 mg/kg, 2-5 years 15 mg/kg. Redosing will be every 6 hours for 24 hours. The two other arms will receive a placebo in the form of normal saline given intravenously. Intraoperative opioids will be administered as deemed necessary by anesthesia c"
216970|NCT01500083|B3|Baseline|Total|Total of all reporting groups
216971|NCT01500083|B2|Baseline|Patients With iNHL|Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
216972|NCT01500083|B1|Baseline|Patients With Previously Untreated CLL|Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
216973|NCT01500083|P2|Participant Flow|Patients With iNHL|Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
216974|NCT01500083|P1|Participant Flow|Patients With Previously Untreated CLL|Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
216975|NCT01500083|O2|Outcome|Patients With iNHL|Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
216976|NCT01500083|O1|Outcome|Patients With Previously Untreated CLL|Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
216977|NCT01500083|E2|Reported Event|Patients With iNHL|Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
216978|NCT01500083|E1|Reported Event|Patients With Previously Untreated CLL|Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
216979|NCT01500057|B3|Baseline|Total|Total of all reporting groups
216980|NCT01500057|B2|Baseline|BiVAP Saline Vaporization|"BiVAP Saline Vaporization of the prostate~BiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization"
216981|NCT01500057|B1|Baseline|Greenlight XPS Laser|"Greenlight XPS Laser of the prostate~Greenlight XPS Laser: Treatment of BPH with Greenlight XPS laser"
216982|NCT01500057|P2|Participant Flow|BiVAP Saline Vaporization|"BiVAP Saline Vaporization of the prostate~BiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization"
216983|NCT01500057|P1|Participant Flow|Greenlight XPS Laser|"Greenlight XPS Laser of the prostate~Greenlight XPS Laser: Treatment of BPH with Greenlight XPS laser"
216984|NCT01500057|O2|Outcome|BiVAP Saline Vaporization|"BiVAP Saline Vaporization of the prostate~BiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization"
216985|NCT01500057|O1|Outcome|Greenlight XPS Laser|"Greenlight XPS Laser of the prostate~Greenlight XPS Laser: Treatment of BPH with Greenlight XPS laser"
216986|NCT01500057|O2|Outcome|BiVAP Saline Vaporization|"BiVAP Saline Vaporization of the prostate~BiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization"
216990|NCT01500057|E2|Reported Event|BiVAP Saline Vaporization|"BiVAP Saline Vaporization of the prostate~BiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization"
216991|NCT01500057|E1|Reported Event|Greenlight XPS Laser|"Greenlight XPS Laser of the prostate~Greenlight XPS Laser: Treatment of BPH with Greenlight XPS laser"
216992|NCT01500031|B1|Baseline|Re-ROUTE|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the OffRoad™ Re-entry Catheter
216993|NCT01500031|P1|Participant Flow|Re-ROUTE|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the OffRoad™ Re-entry Catheter
216994|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
216995|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
216996|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
216997|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
216998|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
216999|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
217000|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
217001|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
217002|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
217003|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
217004|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
217005|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
217006|NCT01500031|E1|Reported Event|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
217007|NCT01499862|B1|Baseline|All Participants|All subjects had reached plateau with conventional Bodyweight-Supported Treadmill Training (BWSTT, participated in task-oriented mobility therapy(1.5 hours, 2-4 times per week for 4 weeks) with Robotic Leg Orthosis (RLO) under the supervision of a physical therapist.
217008|NCT01499862|P1|Participant Flow|Tibion Arm Baseline Assessments|Arm of the study in which enrolled post-stroke subjects undergo rehabilitative therapy with the Tibion Bionic Leg.
217009|NCT01499862|O3|Outcome|Patient 3|Ambulation speed (meters/second)
217010|NCT01499862|O2|Outcome|Patient 2|Ambulation speed (meters/second)
217011|NCT01499862|O1|Outcome|Patient 1|Ambulation speed (meters/second)
217012|NCT01499862|O3|Outcome|Patient 3|Step Length (meters)
217013|NCT01499862|O2|Outcome|Patient 2|Step Length (meters)
217014|NCT01499862|O1|Outcome|Patient 1|Step Length (meters)
217015|NCT01499862|O3|Outcome|Patient 3|Five Times Sit to Stand Test (seconds)
217016|NCT01499862|O2|Outcome|Patient 2|Five Times Sit to Stand Test (seconds)
217017|NCT01499862|O1|Outcome|Patient 1|Five Times Sit to Stand Test (seconds)
217018|NCT01499862|O3|Outcome|Patient 3|Timed Up and Go Test (seconds)
217019|NCT01499862|O2|Outcome|Patient 2|Timed Up and Go Test (seconds)
217020|NCT01499862|O1|Outcome|Patient 1|Timed Up and Go Test (seconds)
217021|NCT01499862|O3|Outcome|Patient 3|Six Minute Walk Test (meters)
217022|NCT01499862|O2|Outcome|Patient 2|Six Minute Walk Test (meters)
217023|NCT01499862|O1|Outcome|Patient 1|Six Minute Walk Test (meters)
217024|NCT01499862|E1|Reported Event|Tibion Arm Baseline Assessments|Arm of the study in which enrolled post-stroke subjects undergo rehabilitative therapy with the Tibion Bionic Leg.
217025|NCT01499849|B3|Baseline|Total|Total of all reporting groups
217026|NCT01499849|B2|Baseline|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
217027|NCT01499849|B1|Baseline|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
217028|NCT01499849|P2|Participant Flow|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
217029|NCT01499849|P1|Participant Flow|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
217030|NCT01499849|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
217031|NCT01499849|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
217032|NCT01499849|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
217119|NCT01499654|B1|Baseline|Study Group|Entire cohort
217120|NCT01499654|P1|Participant Flow|Study Group|Entire cohort
217121|NCT01499654|O3|Outcome|Injection 1 to Injection 2|Time in minutes between the first 1/2 dose injection and the second 1/2 dose injection
217033|NCT01499849|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
217034|NCT01499849|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
217035|NCT01499849|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
217036|NCT01499849|E2|Reported Event|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
217037|NCT01499849|E1|Reported Event|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
217038|NCT01499810|B1|Baseline|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217039|NCT01499810|P1|Participant Flow|Renal Denervation|"All eligible patients undergone bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) was inserted into renal artery and 4-10 point ablations were performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation was performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217040|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergone bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) was inserted into renal artery and 4-10 point ablations were performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation was performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217041|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergone bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) was inserted into renal artery and 4-10 point ablations were performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation was performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217042|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergone bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) was inserted into renal artery and 4-10 point ablations were performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation was performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217043|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergone bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) was inserted into renal artery and 4-10 point ablations were performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation was performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217122|NCT01499654|O2|Outcome|Injection 2 to Scan 2|Time in minutes between the second 1/2 dose injection and the second scan.
217123|NCT01499654|O1|Outcome|Injection 1 to Scan 1|Time in minutes between the first 1/2 dose injection and the first scan
217124|NCT01499654|O1|Outcome|Study Group|Entire cohort
217044|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217045|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217046|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217047|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217048|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217049|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217050|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217051|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217125|NCT01499654|O3|Outcome|Full-dose FBP|Full-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
217126|NCT01499654|O2|Outcome|Half-dose FBP|Half-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
217127|NCT01499654|O1|Outcome|Half-dose WBR|Half-dose Tc-99m sestamibi reconstructed using wide beam reconstruction (WBR)
217128|NCT01499654|O3|Outcome|Full-dose FBP|Full-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
217052|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217053|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217054|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217055|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217056|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217057|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217058|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217059|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217129|NCT01499654|O2|Outcome|Half-dose FBP|Half-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
217130|NCT01499654|O1|Outcome|Half-dose WBR|Half-dose Tc-99m sestamibi reconstructed using wide beam reconstruction (WBR)
217131|NCT01499654|O3|Outcome|Full-dose FBP|Full-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
217132|NCT01499654|O2|Outcome|Half-dose FBP|Half-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
217060|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217061|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217062|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217063|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217064|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217065|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217066|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217067|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217133|NCT01499654|O1|Outcome|Half-dose WBR|Half-dose Tc-99m sestamibi reconstructed using wide beam reconstruction (WBR)
217134|NCT01499654|O3|Outcome|Full-dose FBP|Full-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
217135|NCT01499654|O2|Outcome|Half-dose FBP|Half-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
217136|NCT01499654|O1|Outcome|Half-dose WBR|Half-dose Tc-99m sestamibi reconstructed using wide beam reconstruction (WBR)
217137|NCT01499654|E1|Reported Event|Study Group|Entire cohort for the study
217068|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217069|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217070|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217071|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217072|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217073|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217074|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217075|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217138|NCT01499576|B1|Baseline|Acetic Acid Spraying|Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
217139|NCT01499576|P1|Participant Flow|Acetic Acid Spraying|Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
217140|NCT01499576|O1|Outcome|Acetic Acid Spraying|Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
217141|NCT01499576|O1|Outcome|Acetic Acid Spraying|The same participants primary outcome analysed
217076|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217077|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217078|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217079|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217080|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217081|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217082|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217083|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217142|NCT01499576|O1|Outcome|Acetic Acid Spraying|Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
217143|NCT01499576|E1|Reported Event|Acetic Acid Spraying|Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
217144|NCT01499498|B1|Baseline|Sildenafil and Boceprevir|All subjects take single dose sildenafil 25mg day 0, day 10-15 they take boceprevir 800mg three times a day followed by Intentive PK on day 15 and on day 16 single dose of sildenafil and boceprevir together followed by intensive PK
217084|NCT01499810|E1|Reported Event|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
217085|NCT01499667|B4|Baseline|Total|Total of all reporting groups
217086|NCT01499667|B3|Baseline|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod
217087|NCT01499667|B2|Baseline|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
217088|NCT01499667|B1|Baseline|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
217089|NCT01499667|P3|Participant Flow|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
217090|NCT01499667|P2|Participant Flow|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
217091|NCT01499667|P1|Participant Flow|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
217092|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
217093|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
217094|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
217095|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
217096|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
217097|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
217098|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
217099|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
217100|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
217101|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
217102|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
217103|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
217104|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
217105|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
217106|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
217107|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
217108|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
217109|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
217110|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
217111|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
217112|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
217113|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
217114|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
217115|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
217116|NCT01499667|E3|Reported Event|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
217117|NCT01499667|E2|Reported Event|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
217118|NCT01499667|E1|Reported Event|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
217145|NCT01499498|P1|Participant Flow|Sildenafil and Boceprevir|"Healthy volunteers~Sildenafil and Boceprevir : 25mg once daily/800mg three times a day"
217146|NCT01499498|O1|Outcome|Sildenafil and Boceprevir|"Healthy volunteers~Sildenafil and Boceprevir : 25mg once daily/800mg three times a day"
217147|NCT01499498|O1|Outcome|Sildenafil and Boceprevir|"Healthy volunteers~Sildenafil and Boceprevir : 25mg once daily/800mg three times a day"
217148|NCT01499498|O1|Outcome|Sildenafil and Boceprevir|"Healthy volunteers~Sildenafil and Boceprevir: 25mg once/800mg three times a day"
217149|NCT01499498|O1|Outcome|Bocepreprivir Alone|"Healthy volunteers~Boceprevir: 800mg three times a day"
217150|NCT01499498|O1|Outcome|Sildenafil Only|"Healthy volunteers~Sildenafil 25mg once"
217151|NCT01499498|E1|Reported Event|Sildenafil and Boceprevir|"Healthy volunteers~Sildenafil and Boceprevir : 25mg once daily/800mg three times a day"
217152|NCT01499355|B1|Baseline|All Enrolled Participants|At Run-in Day 1, participants entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10. Following confirmation of eligibility, subjects also received MMF starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2.
217153|NCT01499355|P4|Participant Flow|Double-Blind Period: BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy of oral steroids (prednisone or equivalent) and MMF.
217154|NCT01499355|P3|Participant Flow|Double-Blind Period: BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy of oral steroids (prednisone or equivalent) and MMF.
217155|NCT01499355|P2|Participant Flow|Double-Blind Period: Placebo|Placebo intravenous (IV) infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy of oral steroids (prednisone or equivalent) and MMF.
217156|NCT01499355|P1|Participant Flow|Run-In Period: All Enrolled Participants|At Run-in Day 1, participants entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10. Following confirmation of eligibility, subjects also received mycophenolate mofetil (MMF) starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2.
217157|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217158|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217159|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217160|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217161|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217162|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217163|NCT01499355|O1|Outcome|Run-In: All Enrolled Participants|At Run-in Day 1, participants entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10. Following confirmation of eligibility, subjects also received MMF starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2.
217164|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217165|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217166|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217167|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217168|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217169|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217170|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217171|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217172|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217173|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217174|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217230|NCT01499290|O4|Outcome|Meropenem (TOC)|TOC - 28 to 35 days after start of study drug
217175|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217176|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217177|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217178|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217179|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217180|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217181|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217182|NCT01499355|E4|Reported Event|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217183|NCT01499355|E3|Reported Event|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217184|NCT01499355|E2|Reported Event|Placebo|Placebo intravenous (IV) infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
217185|NCT01499355|E1|Reported Event|Run-in Period|At Run-in Day 1, participants entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10. Following confirmation of eligibility, subjects also received MMF starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2.
217186|NCT01499303|B3|Baseline|Total|Total of all reporting groups
217187|NCT01499303|B2|Baseline|200mg BID|200mg Fostmatinib BID
217188|NCT01499303|B1|Baseline|100mg BID|100mg Fostmatinib BID
217189|NCT01499303|P2|Participant Flow|200mg BID|200mg Fostmatinib BID
217190|NCT01499303|P1|Participant Flow|100mg BID|100mg Fostmatinib BID
217191|NCT01499303|O2|Outcome|200mg BID|200mg Fostmatinib BID
217192|NCT01499303|O1|Outcome|100mg BID|100mg Fostmatinib BID
217193|NCT01499303|E2|Reported Event|200mg BID|200mg Fostmatinib BID
217194|NCT01499303|E1|Reported Event|100mg BID|100mg Fostmatinib BID
217195|NCT01499290|B3|Baseline|Total|Total of all reporting groups
217196|NCT01499290|B2|Baseline|Meropenem|1000 mg: IV treatment
217197|NCT01499290|B1|Baseline|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
217198|NCT01499290|P2|Participant Flow|Meropenem|1000 mg: IV treatment
217199|NCT01499290|P1|Participant Flow|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
217200|NCT01499290|O6|Outcome|AVI (3)|300-360 mins after dose
217201|NCT01499290|O5|Outcome|CAZ (3)|300-360 mins after dose
217202|NCT01499290|O4|Outcome|AVI (2)|30-90 mins after dose
217203|NCT01499290|O3|Outcome|CAZ (2)|30-90 mins after dose
217204|NCT01499290|O2|Outcome|AVI (1)|30 min before/after dose
217205|NCT01499290|O1|Outcome|CAZ (1)|30 mins before/after dose
217206|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
217207|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
217208|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
217209|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
217210|NCT01499290|O4|Outcome|Meropenem (Denominator)|Number of patients with pathogen at baseline
217211|NCT01499290|O3|Outcome|CAZ-AVI + Metronidazole (Denominator)|Number of patients with pathogen at baseline
217212|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
217213|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
217214|NCT01499290|O4|Outcome|Meropenem (Denominator)|Number of patients with pathogen at baseline
217215|NCT01499290|O3|Outcome|CAZ-AVI + Metronidazole (Denominator)|Number of patients with pathogen at baseline
217216|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
217217|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
217218|NCT01499290|O4|Outcome|Meropenem (Denominator)|Number of patients with pathogen at baseline
217219|NCT01499290|O3|Outcome|CAZ-AVI + Metronidazole (Denominator)|Total number of patiets with each pathogen at baseline (summary only shows pathogens where N>/=10)
217220|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment. Number of favourable responses
217221|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment Number of favourable responses
217222|NCT01499290|O6|Outcome|Meropenem (LFU)|LFU - 42 to 49 days after start of study drug
217223|NCT01499290|O5|Outcome|CAZ-AVI + Metronidazole (LFU)|LFU - 42 to 49 days after start of study drug
217224|NCT01499290|O4|Outcome|Meropenem (TOC)|TOC - 28 to 35 days after start of study drug
217225|NCT01499290|O3|Outcome|CAZ-AVI + Metronidazole (TOC)|TOC - 28 to 35 days after start of study drug
217226|NCT01499290|O2|Outcome|Meropenem (EOT)|EOT - within 24 hours after last dose of study drug
217227|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole (EOT)|EOT - within 24 hours after last dose of study drug
217228|NCT01499290|O6|Outcome|Meropenem (LFU)|LFU - 42 to 49 days after start of study drug
217229|NCT01499290|O5|Outcome|CAZ-AVI + Metronidazole (LFU)|LFU - 42 to 49 days after start of study drug
217232|NCT01499290|O2|Outcome|Meropenem (EOT)|EOT - within 24 hours of last dose of study drug
217233|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole (EOT)|EOT - within 24 hours of last dose of study drug
217234|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
217235|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
217236|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
217237|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
217238|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
217239|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
217240|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
217241|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
217242|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
217243|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
217244|NCT01499290|E2|Reported Event|Meropenem|1000 mg: IV treatment
217245|NCT01499290|E1|Reported Event|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment.
217246|NCT01499277|B3|Baseline|Total|Total of all reporting groups
217247|NCT01499277|B2|Baseline|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
217248|NCT01499277|B1|Baseline|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
217249|NCT01499277|P2|Participant Flow|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
217250|NCT01499277|P1|Participant Flow|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
217251|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
217252|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
217253|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
217254|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
217255|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
217256|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
217257|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
217258|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
217259|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
217260|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
217261|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
217262|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
217263|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
217264|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
217265|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
217266|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
217267|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
217268|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
217269|NCT01499277|E2|Reported Event|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
217270|NCT01499277|E1|Reported Event|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
217271|NCT01499199|B1|Baseline|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
217272|NCT01499199|P1|Participant Flow|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
217273|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
217274|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
217275|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
217276|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
217277|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
217278|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
217279|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
217280|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
217281|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
217282|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
217283|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
217284|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
217285|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
217286|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
217367|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on in combination with antidiabetic drug(s).
217287|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
217288|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
217289|NCT01499199|E1|Reported Event|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
217290|NCT01499173|B1|Baseline|Stroke Preparedness Intervention|"Youth and adults from predominately African American chruches in Flint will be enrolled to undergo a faith-based, scientific theory-driven, peer-led behavioral intervention utilizing a pre-post test design.~Stroke Preparedness Intervention: A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches."
217291|NCT01499173|P1|Participant Flow|Stroke Preparedness Intervention|"Youth and adults from predominately African American chruches in Flint will be enrolled to undergo a faith-based, scientific theory-driven, peer-led behavioral intervention utilizing a pre-post test design.~Stroke Preparedness Intervention: A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches."
217292|NCT01499173|O1|Outcome|Stroke Preparedness Intervention|"Youth and adults from predominately African American chruches in Flint will be enrolled to undergo a faith-based, scientific theory-driven, peer-led behavioral intervention utilizing a pre-post test design.~Stroke Preparedness Intervention: A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches."
217293|NCT01499173|O1|Outcome|Stroke Preparedness Intervention|"Youth and adults from predominately African American churches in Flint will be enrolled to undergo a faith-based, scientific theory-driven, peer-led behavioral intervention utilizing a pre-post test design.~Stroke Preparedness Intervention: A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches."
217294|NCT01499173|O1|Outcome|Stroke Preparedness Intervention|"Youth and adults from predominately African American chruches in Flint will be enrolled to undergo a faith-based, scientific theory-driven, peer-led behavioral intervention utilizing a pre-post test design.~Stroke Preparedness Intervention: A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches."
217295|NCT01499173|O1|Outcome|Stroke Preparedness Intervention|"Youth and adults from predominately African American chruches in Flint will be enrolled to undergo a faith-based, scientific theory-driven, peer-led behavioral intervention utilizing a pre-post test design.~Stroke Preparedness Intervention: A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches."
217296|NCT01499173|O1|Outcome|Stroke Preparedness Intervention|"Youth and adults from predominately African American chruches in Flint will be enrolled to undergo a faith-based, scientific theory-driven, peer-led behavioral intervention utilizing a pre-post test design.~Stroke Preparedness Intervention: A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches."
217297|NCT01499173|O1|Outcome|Stroke Preparedness Intervention|"Youth and adults from predominately African American chruches in Flint will be enrolled to undergo a faith-based, scientific theory-driven, peer-led behavioral intervention utilizing a pre-post test design.~Stroke Preparedness Intervention: A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches."
217298|NCT01499173|O1|Outcome|Stroke Preparedness Intervention|"Youth and adults from predominately African American chruches in Flint will be enrolled to undergo a faith-based, scientific theory-driven, peer-led behavioral intervention utilizing a pre-post test design.~Stroke Preparedness Intervention: A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches."
217299|NCT01499173|E1|Reported Event|Stroke Preparedness Intervention|"Youth and adults from predominately African American chruches in Flint will be enrolled to undergo a faith-based, scientific theory-driven, peer-led behavioral intervention utilizing a pre-post test design.~Stroke Preparedness Intervention: A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches."
217300|NCT01499160|B1|Baseline|Letrozole in Combination With Lapatinib Followed by Everolimus|"Group 1: HER2-positive in the tumor tissue Group 2: HER2 negative in the tumor tissue~In the first part of the study, all of the patients will receive the combination of lapatinib 1,500 mg/day and letrozole 2.5 mg/day. Restaging scans (CT scan, MRI, or bone scan) will be obtained after every 12 weeks of treatment. In those patients who progress from any group, everolimus 5 mg/day will be added to letrozole and lapatinib will be reduced to 1,250 mg/day as per the SWOG phase I study of lapatinib and everolimus.~letrozole: Drug is are to be taken orally. 2.5 mg once daily~lapatinib: Drug is to be taken orally. 1,500 mg once daily in the first part of the study and then 1,250 mg once daily in the second part of the study (after initial progression)~everolimus: Drug is to be taken orally. 5 mg once daily."
217301|NCT01499160|P1|Participant Flow|Letrozole in Combination With Lapatinib Followed by Everolimus|"Group 1: HER2-positive in the tumor tissue Group 2: HER2 negative in the tumor tissue~In the first part of the study, all of the patients will receive the combination of lapatinib 1,500 mg/day and letrozole 2.5 mg/day. Restaging scans (CT scan, MRI, or bone scan) will be obtained after every 12 weeks of treatment. In those patients who progress from any group, everolimus 5 mg/day will be added to letrozole and lapatinib will be reduced to 1,250 mg/day as per the SWOG phase I study of lapatinib and everolimus.~letrozole: Drug is are to be taken orally. 2.5 mg once daily~lapatinib: Drug is to be taken orally. 1,500 mg once daily in the first part of the study and then 1,250 mg once daily in the second part of the study (after initial progression)~everolimus: Drug is to be taken orally. 5 mg once daily."
217315|NCT01499147|O1|Outcome|Fludarabine/Busulfan + ATG|"All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.~fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI."
217368|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
217302|NCT01499160|O1|Outcome|Letrozole in Combination With Lapatinib Followed by Everolimus|"Group 1: HER2-positive in the tumor tissue Group 2: HER2 negative in the tumor tissue~In the first part of the study, all of the patients will receive the combination of lapatinib 1,500 mg/day and letrozole 2.5 mg/day. Restaging scans (CT scan, MRI, or bone scan) will be obtained after every 12 weeks of treatment. In those patients who progress from any group, everolimus 5 mg/day will be added to letrozole and lapatinib will be reduced to 1,250 mg/day as per the SWOG phase I study of lapatinib and everolimus.~letrozole: Drug is are to be taken orally. 2.5 mg once daily~lapatinib: Drug is to be taken orally. 1,500 mg once daily in the first part of the study and then 1,250 mg once daily in the second part of the study (after initial progression)~everolimus: Drug is to be taken orally. 5 mg once daily."
217303|NCT01499160|O1|Outcome|Letrozole in Combination With Lapatinib Followed by Everolimus|"Group 1: HER2-positive in the tumor tissue-2 subjects Group 2: HER2 negative in the tumor tissue-5 subjects~In the first part of the study, all of the patients will receive the combination of lapatinib 1,500 mg/day and letrozole 2.5 mg/day. Restaging scans (CT scan, MRI, or bone scan) will be obtained after every 12 weeks of treatment. In those patients who progress from any group, everolimus 5 mg/day will be added to letrozole and lapatinib will be reduced to 1,250 mg/day as per the SWOG phase I study of lapatinib and everolimus.~letrozole: Drug is are to be taken orally. 2.5 mg once daily~lapatinib: Drug is to be taken orally. 1,500 mg once daily in the first part of the study and then 1,250 mg once daily in the second part of the study (after initial progression)~everolimus: Drug is to be taken orally. 5 mg once daily."
217304|NCT01499160|E1|Reported Event|Letrozole in Combination With Lapatinib Followed by Everolimus|"Group 1: HER2-positive in the tumor tissue Group 2: HER2 negative in the tumor tissue~In the first part of the study, all of the patients will receive the combination of lapatinib 1,500 mg/day and letrozole 2.5 mg/day. Restaging scans (CT scan, MRI, or bone scan) will be obtained after every 12 weeks of treatment. In those patients who progress from any group, everolimus 5 mg/day will be added to letrozole and lapatinib will be reduced to 1,250 mg/day as per the SWOG phase I study of lapatinib and everolimus.~letrozole: Drug is are to be taken orally. 2.5 mg once daily~lapatinib: Drug is to be taken orally. 1,500 mg once daily in the first part of the study and then 1,250 mg once daily in the second part of the study (after initial progression)~everolimus: Drug is to be taken orally. 5 mg once daily."
217305|NCT01499147|B3|Baseline|Total|Total of all reporting groups
217306|NCT01499147|B2|Baseline|Arm 2|"All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.~fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl)."
217307|NCT01499147|B1|Baseline|Arm 1|"All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.~fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI."
217308|NCT01499147|P2|Participant Flow|Fludarabine/Melphalan + ATG|"All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.~fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl)."
217309|NCT01499147|P1|Participant Flow|Fludarabine/Busulfan + ATG|"All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.~fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI."
217310|NCT01499147|O2|Outcome|Fludarabine/Melphalan +ATG|"All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.~fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl)."
217311|NCT01499147|O1|Outcome|Fludarabine/Busulfan + ATG|"All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.~fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI."
217312|NCT01499147|O2|Outcome|Fludarabine/Melphalan + ATG|"All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.~fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl).~ATG: Patients receiving a transplant from a matched unrelated or mismatched related/unrelated donor would receive ATG in the conditioning regimen."
217313|NCT01499147|O1|Outcome|Fludarabine/Busulfan + ATG|"All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.~fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI.~ATG: Patients receiving a transplant from a matched unrelated or mismatched related/unrelated donor would receive ATG in the conditioning regimen."
217314|NCT01499147|O2|Outcome|Fludarabine/Melphalan + ATG|"All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.~fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl)."
217366|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
217316|NCT01499147|O2|Outcome|Fludarabine/Melphalan + ATG|"All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.~fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl)."
217317|NCT01499147|O1|Outcome|Fludarabine/Busulfan + ATG|"All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.~fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI."
217318|NCT01499147|E3|Reported Event|FluMel Participants With Extra-hematological Toxicities|We analyzed if different rates of severe extra-hematological toxicities could be detected in patients conditioned with FluMel and receiving PBSC.
217319|NCT01499147|E2|Reported Event|FluBu Participants With Extra-hematological Toxicities|We analyzed if different rates of severe extra-hematological toxicities could be detected in patients conditioned with FluBu and receiving PBSC.
217320|NCT01499147|E1|Reported Event|Participants With Extra-hematological Toxicities|We analyzed if different rates of severe extra-hematological toxicities could be detected in patients conditioned with FluBu and FluMel and receiving PBSC.
217321|NCT01499134|B3|Baseline|Total|Total of all reporting groups
217322|NCT01499134|B2|Baseline|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
217323|NCT01499134|B1|Baseline|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
217324|NCT01499134|P2|Participant Flow|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
217325|NCT01499134|P1|Participant Flow|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
217326|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
217327|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
217328|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
217329|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
217330|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
217331|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
217332|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
217333|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
217334|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
217441|NCT01498744|B3|Baseline|Total|Total of all reporting groups
217335|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
217336|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
217337|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
217338|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
217339|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
217340|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
217341|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
217342|NCT01499134|E2|Reported Event|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
217343|NCT01499134|E1|Reported Event|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
217344|NCT01499095|B3|Baseline|Total|Total of all reporting groups
217345|NCT01499095|B2|Baseline|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
217346|NCT01499095|B1|Baseline|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
217347|NCT01499095|P2|Participant Flow|Lantus|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s).
217348|NCT01499095|P1|Participant Flow|HOE901-U300|HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s).
217349|NCT01499095|O2|Outcome|HOE901­U300: Fixed Dosing Intervals|HOE901­U300 SC injection once daily for 12 months in combination with of oral antidiabetic drug(s). From Month 6 up to Month 9 participants received HOE901­U300 once daily every 24 hours.
217350|NCT01499095|O1|Outcome|HOE901­U300: Adaptable Dosing Intervals|HOE901­U300 SC injection once daily for 6 months in combination with oral antidiabetic drug(s). From Month 6 to Month 9 participants received HOE901­U300 once daily at intervals of 24 +/­ 3 hours.
217351|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
217352|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
217353|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
217354|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
217355|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
217356|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
217357|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
217358|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
217359|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
217360|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
217361|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
217362|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
217363|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
217364|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
217365|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
217369|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
217370|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
217371|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
217372|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
217373|NCT01499095|E2|Reported Event|LANTUS|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
217374|NCT01499095|E1|Reported Event|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
217375|NCT01499082|B3|Baseline|Total|Total of all reporting groups
217376|NCT01499082|B2|Baseline|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
217377|NCT01499082|B1|Baseline|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
217378|NCT01499082|P2|Participant Flow|Lantus|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of mealtime insulin analogue.
217379|NCT01499082|P1|Participant Flow|HOE901-U300|HOE901­U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months on top of mealtime insulin analogue.
217380|NCT01499082|O2|Outcome|HOE901-U300: Fixed Dosing Intervals|HOE901-U300 SC injection once daily for 6 months on top of mealtime insulin. From Month 6 up to Month 9 participants received HOE901-U300 once daily every 24 hours.
217381|NCT01499082|O1|Outcome|HOE901-U300: Adaptable Dosing Intervals|HOE901-U300 SC injection once daily for 6 months on top of mealtime insulin. From Month 6 to Month 9 participants received HOE901-U300 once daily at intervals of 24 +/- 3 hours.
217382|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
217383|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
217384|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
217385|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
217386|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
217387|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
217388|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
217389|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
217390|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
217391|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
217392|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
217393|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
217394|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
217395|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
217396|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
217397|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
217398|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
217399|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
217400|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
217401|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
217402|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
217403|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
217404|NCT01499082|E2|Reported Event|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
217405|NCT01499082|E1|Reported Event|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
217406|NCT01498978|B1|Baseline|Treatment (Ipilimumab)|"Patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients without progression then receive maintenance ipilimumab IV once every 3 months for 4 additional doses.~ipilimumab: Given IV~laboratory biomarker analysis: Correlative studies"
217407|NCT01498978|P1|Participant Flow|Treatment (Ipilimumab)|"Patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients without progression then receive maintenance ipilimumab IV once every 3 months for 4 additional doses.~ipilimumab: Given IV~laboratory biomarker analysis: Correlative studies"
217408|NCT01498978|O2|Outcome|No: IRAE|"Patients that did not experience an IRAE.~Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event."
217409|NCT01498978|O1|Outcome|Yes: IRAE|"Patients that experienced an IRAE.~Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event."
217410|NCT01498978|O2|Outcome|No: IRAE|"Patients that did not experience an IRAE.~Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event."
217411|NCT01498978|O1|Outcome|Yes: IRAE|"Patients that experienced an IRAE.~Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event."
217412|NCT01498978|O2|Outcome|No: IRAE|"Patients that did not experience an IRAE.~Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event."
217567|NCT01498458|B1|Baseline|Pazopanib Plus Capecitabine|pazopanib plus capecitabine
217413|NCT01498978|O1|Outcome|Yes: IRAE|"Patients that experienced an IRAE.~Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event."
217414|NCT01498978|O2|Outcome|No: IRAE|"Patients that did not experience an IRAE.~Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event."
217415|NCT01498978|O1|Outcome|Yes: IRAE|"Patients that experienced an IRAE.~Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event."
217416|NCT01498978|O2|Outcome|No: IRAE|"Patients that did not experience an IRAE.~Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event."
217417|NCT01498978|O1|Outcome|Yes: IRAE|"Patients that experienced an IRAE.~Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event."
217418|NCT01498978|O2|Outcome|No: IRAE|"Patients that did not experience an IRAE.~Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event."
217419|NCT01498978|O1|Outcome|Yes: IRAE|"Patients that experienced an IRAE.~Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event."
217420|NCT01498978|O1|Outcome|Treatment (Ipilimumab)|"Patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients without progression then receive maintenance ipilimumab IV once every 3 months for 4 additional doses.~ipilimumab: Given IV~laboratory biomarker analysis: Correlative studies"
217421|NCT01498978|O1|Outcome|Treatment (Ipilimumab)|"Patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients without progression then receive maintenance ipilimumab IV once every 3 months for 4 additional doses.~ipilimumab: Given IV~laboratory biomarker analysis: Correlative studies"
217422|NCT01498978|O1|Outcome|Treatment (Ipilimumab)|"Patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients without progression then receive maintenance ipilimumab IV once every 3 months for 4 additional doses.~ipilimumab: Given IV~laboratory biomarker analysis: Correlative studies"
217423|NCT01498978|O1|Outcome|Treatment (Ipilimumab)|"Patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients without progression then receive maintenance ipilimumab IV once every 3 months for 4 additional doses.~ipilimumab: Given IV~laboratory biomarker analysis: Correlative studies"
217424|NCT01498978|O1|Outcome|Treatment (Ipilimumab)|"Patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients without progression then receive maintenance ipilimumab IV once every 3 months for 4 additional doses.~ipilimumab: Given IV~laboratory biomarker analysis: Correlative studies"
217425|NCT01498978|E1|Reported Event|Treatment (Ipilimumab)|"Patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients without progression then receive maintenance ipilimumab IV once every 3 months for 4 additional doses.~ipilimumab: Given IV~laboratory biomarker analysis: Correlative studies"
217426|NCT01498822|B3|Baseline|Total Title|
217427|NCT01498822|B2|Baseline|Oxcarbazepine|"Oxcarbazepine twice a day treatment Group~150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)"
217428|NCT01498822|B1|Baseline|Levetiracetam|"Levetiracetam twice a day treatment Group~250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks"
217429|NCT01498822|P2|Participant Flow|Oxcarbazepine|"Oxcarbazepine twice a day treatment Group~150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)"
217430|NCT01498822|P1|Participant Flow|Levetiracetam|"Levetiracetam twice a day treatment Group~250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks"
217431|NCT01498822|O2|Outcome|Full Analysis Set (OXC Treated Subjects)|150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)
217432|NCT01498822|O1|Outcome|Full Analysis Set (LEV Treated Subjects)|250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks
217433|NCT01498822|O2|Outcome|Full Analysis Set (OXC Treated Subjects)|150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)
217434|NCT01498822|O1|Outcome|Full Analysis Set (LEV Treated Subjects)|250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks
217435|NCT01498822|O2|Outcome|Full Analysis Set (OXC Treated Subjects)|150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)
217436|NCT01498822|O1|Outcome|Full Analysis Set (LEV Treated Subjects)|250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks
217437|NCT01498822|O2|Outcome|Per Protocol Set (OXC Treated Subjects)|150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)
217438|NCT01498822|O1|Outcome|Per Protocol Set (LEV Treated Subjects)|250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks
217439|NCT01498822|E2|Reported Event|Oxcarbazepine|"Oxcarbazepine twice a day treatment Group~150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)"
217440|NCT01498822|E1|Reported Event|Levetiracetam|"Levetiracetam twice a day treatment Group~250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks"
217442|NCT01498744|B2|Baseline|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
217443|NCT01498744|B1|Baseline|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
217444|NCT01498744|P2|Participant Flow|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
217445|NCT01498744|P1|Participant Flow|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
217446|NCT01498744|O2|Outcome|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
217447|NCT01498744|O1|Outcome|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
217448|NCT01498744|O2|Outcome|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
217449|NCT01498744|O1|Outcome|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
217450|NCT01498744|O2|Outcome|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
217451|NCT01498744|O1|Outcome|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
217452|NCT01498744|O2|Outcome|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
217490|NCT01498679|O2|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
217491|NCT01498679|O1|Outcome|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
217568|NCT01498458|P1|Participant Flow|Pazopanib Plus Capecitabine|The baseline refers only to the 8 patients who received Pazopanib.
217453|NCT01498744|O1|Outcome|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
217454|NCT01498744|E2|Reported Event|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
217455|NCT01498744|E1|Reported Event|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
217456|NCT01498692|B1|Baseline|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217457|NCT01498692|P1|Participant Flow|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217458|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217459|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217460|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217461|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217462|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217463|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217464|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217465|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217466|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217467|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217468|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217469|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217470|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217471|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217472|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217473|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217474|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217475|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217476|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217477|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217478|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217479|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217480|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217481|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217482|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217483|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217484|NCT01498692|E1|Reported Event|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
217485|NCT01498679|B3|Baseline|Total|Total of all reporting groups
217486|NCT01498679|B2|Baseline|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
217487|NCT01498679|B1|Baseline|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
217488|NCT01498679|P2|Participant Flow|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 100/25 micrograms (µg) OD in the evening,via a DPI, for a period of 12 weeks.
217489|NCT01498679|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening,via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
217566|NCT01498549|E1|Reported Event|Atomoxetine 40 mg|Atomoxetine 40 mg dose
217492|NCT01498679|O2|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
217493|NCT01498679|O1|Outcome|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
217494|NCT01498679|O2|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
217495|NCT01498679|O1|Outcome|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
217496|NCT01498679|O2|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
217497|NCT01498679|O1|Outcome|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
217498|NCT01498679|O2|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
217499|NCT01498679|O1|Outcome|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
217500|NCT01498679|E2|Reported Event|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
217501|NCT01498679|E1|Reported Event|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
217502|NCT01498653|B3|Baseline|Total|Total of all reporting groups
217503|NCT01498653|B2|Baseline|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
217504|NCT01498653|B1|Baseline|Fluticasone Furoate/Vilanterol 200/25 µg OD|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
217505|NCT01498653|P2|Participant Flow|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
217506|NCT01498653|P1|Participant Flow|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening,via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
217507|NCT01498653|O2|Outcome|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
217508|NCT01498653|O1|Outcome|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
217509|NCT01498653|O2|Outcome|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
217510|NCT01498653|O1|Outcome|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
217511|NCT01498653|O2|Outcome|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
217512|NCT01498653|O1|Outcome|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
217513|NCT01498653|O2|Outcome|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
217514|NCT01498653|O1|Outcome|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
217515|NCT01498653|O2|Outcome|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
217516|NCT01498653|O1|Outcome|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
217517|NCT01498653|E2|Reported Event|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
217518|NCT01498653|E1|Reported Event|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
217519|NCT01498640|B1|Baseline|XIAFLEX/XIAPEX|XIAFLEX/XIAPEX: up to three 0.58 mg injections
217520|NCT01498640|P1|Participant Flow|XIAFLEX/XIAPEX|XIAFLEX/XIAPEX: up to three 0.58 mg injections
217521|NCT01498640|O1|Outcome|XIAFLEX/XIAPEX|XIAFLEX/XIAPEX: up to three 0.58 mg injections
217522|NCT01498640|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the PIP joint cord
217523|NCT01498640|O1|Outcome|XIAFLEX/XIAPEX MP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the MP joint cord
217524|NCT01498640|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the PIP joint cord
217525|NCT01498640|O1|Outcome|XIAFLEX/XIAPEX MP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the MP joint cord
217526|NCT01498640|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the PIP joint cord
217527|NCT01498640|O1|Outcome|XIAFLEX/XIAPEX MP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the MP joint cord
217528|NCT01498640|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the PIP joint cord
217529|NCT01498640|O1|Outcome|XIAFLEX/XIAPEX MP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the MP joint cord
217530|NCT01498640|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord
217531|NCT01498640|O1|Outcome|XIAFLEX/XIAPEX MP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord
217532|NCT01498640|E1|Reported Event|XIAFLEX/XIAPEX|XIAFLEX/XIAPEX: up to three 0.58 mg injections
217533|NCT01498601|B3|Baseline|Total|Total of all reporting groups
217534|NCT01498601|B2|Baseline|Retrospective Study Group|Subjects were neurologically impaired, dependent adults who met inclusion criteria. Subjects were identified through a retrospective chart review for the same in-patient unit.
217535|NCT01498601|B1|Baseline|Oral Care Treatment Group|Subjects were neurologically impaired, dependent adults who met inclusion criteria. Subjects were identified upon admission to the in-patient unit during the study period.
217536|NCT01498601|P2|Participant Flow|Oral Care Treatment Group|"All subjects in the intervention group received the enhanced oral care protocol:~Changing mouth suction equipment every 24 hours~Mouth assessment every 2-4 hours~Cleansing mouth with toothbrush every 12 hours~Cleansing oral mucosa with oral rinse solution every 2-4 hours~Moisturize mouth/lips with swab and standard mouth moisturizer every 4 hours~Suction mouth and throat as needed~Head of the bed elevated to a minimum of 30° during oral care"
217537|NCT01498601|P1|Participant Flow|Retrospective Study Group|A retrospective chart review identified matched in-patients meeting the study inclusion criteria.
217538|NCT01498601|O2|Outcome|Retrospective Study Group|Acute neurologically impaired adults in the retrospective chart review
217539|NCT01498601|O1|Outcome|Oral Care Treatment Group|Acute neurologically impaired adults receiving the study protocol
217540|NCT01498601|E2|Reported Event|Retrospective Study Group|Subjects were identified through a chart review process for in-patients on the study unit unit during the retrospective study period and met the inclusion criteria .
217541|NCT01498601|E1|Reported Event|Oral Care Treatment Group|Subjects meeting the inclusion criteria and identified at the point of admission to the in-patient unit during the study period.
217542|NCT01498588|B1|Baseline|Eribulin+Doxorubicin+Cyclophosphamide|"Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide~Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:~Day 1: Eribulin 1.4mg/m² IV~Day 8: Eribulin 1.4mg/m² IV~Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:~Day 1: Doxorubicin 60mg/m² IV~Day 1: Cyclophosphamide 600mg/m² IV~Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy"
217543|NCT01498588|P1|Participant Flow|Eribulin+Doxorubicin+Cyclophosphamide|"Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide~Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:~Day 1: Eribulin 1.4mg/m² IV~Day 8: Eribulin 1.4mg/m² IV~Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:~Day 1: Doxorubicin 60mg/m² IV~Day 1: Cyclophosphamide 600mg/m² IV~Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy"
217544|NCT01498588|O1|Outcome|Eribulin+Doxorubicin+Cyclophosphamide|"Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide~Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:~Day 1: Eribulin 1.4mg/m² IV~Day 8: Eribulin 1.4mg/m² IV~Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:~Day 1: Doxorubicin 60mg/m² IV~Day 1: Cyclophosphamide 600mg/m² IV~Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy"
217545|NCT01498588|O1|Outcome|Eribulin+Doxorubicin+Cyclophosphamide|"Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide~Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:~Day 1: Eribulin 1.4mg/m² IV~Day 8: Eribulin 1.4mg/m² IV~Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:~Day 1: Doxorubicin 60mg/m² IV~Day 1: Cyclophosphamide 600mg/m² IV~Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy"
217546|NCT01498588|E1|Reported Event|Eribulin+Doxorubicin+Cyclophosphamide|"Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide~Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:~Day 1: Eribulin 1.4mg/m² IV~Day 8: Eribulin 1.4mg/m² IV~Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:~Day 1: Doxorubicin 60mg/m² IV~Day 1: Cyclophosphamide 600mg/m² IV~Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy"
217547|NCT01498575|B3|Baseline|Total|Total of all reporting groups
217548|NCT01498575|B2|Baseline|Usual Practice|Use of typical supervised practice driving resources
217549|NCT01498575|B1|Baseline|Teen Driving Plan|"Access to web-based driving intervention~Teen driving plan: Web-based intervention designed to facilitate parent supervised practice driving with novice teen driver."
217550|NCT01498575|P2|Participant Flow|Usual Practice (Control)|Use of typical supervised practice driving resources
217551|NCT01498575|P1|Participant Flow|Teen Driving Plan (TDP)|"Access to web-based driving intervention~Teen driving plan: Web-based intervention designed to facilitate parent supervised practice driving with novice teen driver."
217552|NCT01498575|O2|Outcome|Usual Practice (Control)|Participants received a hard copy of the Pennsylvania driver's manual, also available online and at licensing centers.
217553|NCT01498575|O1|Outcome|Teen Driving Plan (TDP)|Access to web-based driving intervention that provides practice supervisors with specific guidance for facilitating supervision of teens' practice drives across several environments and conditions (eg., highways, commercial districts) using brief instructional videos and resources.
217554|NCT01498575|E2|Reported Event|Usual Practice (Control)|Use of typical supervised practice driving resources
217555|NCT01498575|E1|Reported Event|Teen Driving Plan (TDP)|"Access to web-based driving intervention~Teen driving plan: Web-based intervention designed to facilitate parent supervised practice driving with novice teen driver."
217556|NCT01498549|B1|Baseline|Total Sample|This is the summary of the total sample used in the crossover design.
217557|NCT01498549|P1|Participant Flow|Participants|Participants were randomly assigned to one of 3 possible groups over a 3 day assessment period.
217558|NCT01498549|O3|Outcome|Sugar Pill 0mg|Sugar pill 0 mg dose
217559|NCT01498549|O2|Outcome|Atomoxetine 80 mg|Atomoxetine 80 mg dose
217560|NCT01498549|O1|Outcome|Atomoxetine 40 mg|Atomoxetine 40 mg dose
217561|NCT01498549|O3|Outcome|Sugar Pill 0mg|Sugar pill 0mg dose
217562|NCT01498549|O2|Outcome|Atomoxetine 80 mg|Atomoxetine 80 mg dose
217563|NCT01498549|O1|Outcome|Atomoxetine 40 mg|Atomoxetine 40 mg dose
217564|NCT01498549|E3|Reported Event|Sugar Pill 0 mg|Sugar pill 0 mg dose
217565|NCT01498549|E2|Reported Event|Atomoxetine 80 mg|Atomoxetine 80 mg dose
217569|NCT01498458|O1|Outcome|Pazopanib Plus Capecitabine|2 patients were on study treatment for a long time.
217570|NCT01498458|O1|Outcome|Pazopanib Plus Capecitabine|
217571|NCT01498458|O1|Outcome|Pazopanib Plus Capecitabine|pazopanib together with capecitabine
217572|NCT01498458|O1|Outcome|Pazopanib + Capecitabine|Pazopanib and Capecitabine
217573|NCT01498458|O1|Outcome|Pazopanib Plus Capecitabine|The following DLTs resulted in permanent discontinuation of the study therapy: hypertension, (DLT 1), mucositis CTC grade 3, hand-foot-syndrome CTC grade 3, increase of liver enzymes (GOT,- and GPT) CTC grade 2 (DLT 2), and increase of liver enzymes (GOT-, GPT) CTC grade 3 (DLT 3).
217574|NCT01498458|O1|Outcome|Pazopanib Plus Capecitabine|A maximal tolerated dose (MTD) could not be established. The study was stopped after 8 patients.
217575|NCT01498458|E1|Reported Event|Pazopanib Plus Capecitabine|There was only one arm in this study as this was a dose escalation study.
217576|NCT01498419|B5|Baseline|Total|Total of all reporting groups
217577|NCT01498419|B4|Baseline|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217578|NCT01498419|B3|Baseline|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
217579|NCT01498419|B2|Baseline|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217580|NCT01498419|B1|Baseline|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217581|NCT01498419|P4|Participant Flow|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217582|NCT01498419|P3|Participant Flow|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
217583|NCT01498419|P2|Participant Flow|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217584|NCT01498419|P1|Participant Flow|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217585|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217586|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
217587|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217588|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217589|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217590|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
217591|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217592|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217593|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217594|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
217595|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217596|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217597|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217598|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
217638|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
217599|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217600|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217601|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217602|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
217603|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217604|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217605|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217606|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
217607|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217608|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217609|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217610|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
217611|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217612|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217613|NCT01498419|E4|Reported Event|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217614|NCT01498419|E3|Reported Event|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
217615|NCT01498419|E2|Reported Event|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217616|NCT01498419|E1|Reported Event|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
217617|NCT01498185|B6|Baseline|Total|Total of all reporting groups
217618|NCT01498185|B5|Baseline|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
217619|NCT01498185|B4|Baseline|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
217620|NCT01498185|B3|Baseline|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
217621|NCT01498185|B2|Baseline|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
217622|NCT01498185|B1|Baseline|Placebo + Insulin|Tablets, oral, once daily for 2 weeks
217623|NCT01498185|P5|Participant Flow|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
217624|NCT01498185|P4|Participant Flow|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
217625|NCT01498185|P3|Participant Flow|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
217626|NCT01498185|P2|Participant Flow|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
217627|NCT01498185|P1|Participant Flow|Placebo + Insulin|Tablets, oral, once daily for 2 weeks
217628|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
217629|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
217630|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
217631|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
217632|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
217633|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
217634|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
217635|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
217636|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
217637|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
217639|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
217640|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
217641|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
217642|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
217643|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
217644|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
217645|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
217646|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
217647|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
217648|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
217649|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
217650|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
217651|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
217652|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
217653|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
217654|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
217655|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
217656|NCT01498185|O5|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
217657|NCT01498185|O4|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
217658|NCT01498185|O3|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
217659|NCT01498185|O2|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
217660|NCT01498185|O1|Outcome|Placebo + Insulin|Tablets, oral, once daily for 2 weeks
217661|NCT01498185|E5|Reported Event|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
217662|NCT01498185|E4|Reported Event|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
217663|NCT01498185|E3|Reported Event|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
217664|NCT01498185|E2|Reported Event|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
217665|NCT01498185|E1|Reported Event|Placebo + Insulin|Tablets, oral, once daily for 2 weeks
217666|NCT01498120|B1|Baseline|Rotigotine|Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
217667|NCT01498120|P1|Participant Flow|Rotigotine|Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
217668|NCT01498120|O1|Outcome|Rotigotine (Safety Set)|The Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication. Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
217669|NCT01498120|O1|Outcome|Rotigotine (Safety Set)|The Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication. Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
217670|NCT01498120|E1|Reported Event|Rotigotine (Safety Set)|The Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication. Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
217671|NCT01498068|B3|Baseline|Total|Total of all reporting groups
217672|NCT01498068|B2|Baseline|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
217673|NCT01498068|B1|Baseline|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
217674|NCT01498068|P2|Participant Flow|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
217675|NCT01498068|P1|Participant Flow|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
217676|NCT01498068|O2|Outcome|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
217701|NCT01497899|B5|Baseline|Total|Total of all reporting groups
217677|NCT01498068|O1|Outcome|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
217678|NCT01498068|O2|Outcome|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
217679|NCT01498068|O1|Outcome|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
217680|NCT01498068|O2|Outcome|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
217681|NCT01498068|O1|Outcome|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
217682|NCT01498068|O2|Outcome|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
217683|NCT01498068|O1|Outcome|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
217684|NCT01498068|O2|Outcome|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
217685|NCT01498068|O1|Outcome|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
217686|NCT01498068|O2|Outcome|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
217687|NCT01498068|O1|Outcome|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
217688|NCT01498068|E2|Reported Event|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
217689|NCT01498068|E1|Reported Event|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
217690|NCT01497938|B3|Baseline|Total|Total of all reporting groups
217691|NCT01497938|B2|Baseline|Control Arm|"The Low Glucose Suspend feature will not be available to subjects in the control arm~Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump : No Automatic suspension of insulin delivery when glucose is low."
217692|NCT01497938|B1|Baseline|Low Glucose Suspend Feature (LGS)|"According to randomization, Low Glucose Suspend (LGS) will be turned ON in the treatment arm of the study~Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature : Automatic suspension of insulin delivery when glucose is low."
217693|NCT01497938|P2|Participant Flow|Control Arm|"The Low Glucose Suspend feature will not be available to subjects in the control arm~Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump : No Automatic suspension of insulin delivery when glucose is low."
217694|NCT01497938|P1|Participant Flow|Low Glucose Suspend Feasure (LGS)|"According to randomization, Low Glucose Suspend (LGS) will be turned ON in the treatment arm of the study~Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature : Automatic suspension of insulin delivery when glucose is low."
217695|NCT01497938|O2|Outcome|Group B Without Low Glucose Suspend (LGS) Feature|
217696|NCT01497938|O1|Outcome|Group A With Low Glucose Suspend (LGS) Feature Turned 'ON'|
217697|NCT01497938|O2|Outcome|Group B Without Low Glucose Suspend (LGS) Feature|
217698|NCT01497938|O1|Outcome|Group A With Low Glucose Suspend (LGS) Feature Turned 'ON'|
217699|NCT01497938|E2|Reported Event|Group B Without Low Glucose Suspend (LGS) Feature|
217700|NCT01497938|E1|Reported Event|Group A With Low Glucose Suspend (LGS) Feature Turned 'ON'|
217702|NCT01497899|B4|Baseline|DRV+COBI+TVD to Open-Label E/C/F/TAF|Participants previously received DRV+COBI+TVD in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
217703|NCT01497899|B3|Baseline|D/C/F/TAF to Open-Label E/C/F/TAF|Participants previously received D/C/F/TAF in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
217704|NCT01497899|B2|Baseline|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
217705|NCT01497899|B1|Baseline|E/C/F/TAF|"Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks~Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
217706|NCT01497899|P4|Participant Flow|DRV+COBI+TVD to Open-Label E/C/F/TAF|Participants previously received darunavir (DRV) + cobicistat (COBI) + Truvada® (TVD) in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
217707|NCT01497899|P3|Participant Flow|D/C/F/TAF to Open-Label E/C/F/TAF|Participants previously received darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
217708|NCT01497899|P2|Participant Flow|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
217709|NCT01497899|P1|Participant Flow|E/C/F/TAF|"Double-Blind Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) placebo tablet administered orally once daily for 48 weeks~Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
217710|NCT01497899|O2|Outcome|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
217711|NCT01497899|O1|Outcome|E/C/F/TAF|"Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks~Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
217712|NCT01497899|O2|Outcome|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
217713|NCT01497899|O1|Outcome|E/C/F/TAF|"Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks~Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
217714|NCT01497899|O2|Outcome|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
217715|NCT01497899|O1|Outcome|E/C/F/TAF|"Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks~Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
217716|NCT01497899|O2|Outcome|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
217717|NCT01497899|O1|Outcome|E/C/F/TAF|"Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks~Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
217718|NCT01497899|E3|Reported Event|All E/C/F/TAF|"Adverse events in this reporting group include those that occurred any time during the study by participants while receiving E/C/F/TAF.~Participants received blinded or open-label E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
217719|NCT01497899|E2|Reported Event|E/C/F/TDF|"Adverse events in this reporting group include those that occurred during the double-blind phase by participants randomized to E/C/F/TDF.~Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks; Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
217720|NCT01497899|E1|Reported Event|E/C/F/TAF|"Adverse events in this reporting group include those that occurred during the double-blind phase by participants randomized to E/C/F/TAF.~Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks; Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
217721|NCT01497756|B1|Baseline|CAPP Application|Patients in whom device is used
217722|NCT01497756|P1|Participant Flow|CAPP Application|Patients in whom device is used
217723|NCT01497756|O1|Outcome|CAPP Application|Patients in whom device is used
217724|NCT01497756|O1|Outcome|CAPP Application|Patients in whom device is used
217725|NCT01497756|E1|Reported Event|CAPP Application|Patients in whom device is used
217726|NCT01497665|B1|Baseline|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
217727|NCT01497665|P1|Participant Flow|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
217728|NCT01497665|O1|Outcome|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
217729|NCT01497665|O1|Outcome|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
217730|NCT01497665|O1|Outcome|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
217731|NCT01497665|O1|Outcome|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
217732|NCT01497665|O1|Outcome|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
217733|NCT01497665|E1|Reported Event|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
217734|NCT01497613|B3|Baseline|Total|Total of all reporting groups
217735|NCT01497613|B2|Baseline|PRISM C: Computer Condition|"A computer-based system designed to support socialization and access to resources; knowledge and prospective memory. The system is placed in the homes of those randomized to the condition for 12 months.~PRISM C: Computer Condition: A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory"
217736|NCT01497613|B1|Baseline|PRISM B: Notebook Condition|"Telephone check-in calls and a notebook containing similar categories of information as the features on the PRISM C computer system such as a resource guide; games; classroom and information, calendar.~PRISM B: Notebook Condition: Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list."
217737|NCT01497613|P2|Participant Flow|PRISM C: Computer Condition|"A computer-based system designed to support socialization and access to resources; knowledge and prospective memory. The system is placed in the homes of those randomized to the condition for 12 months.~PRISM C: Computer Condition: A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory"
217738|NCT01497613|P1|Participant Flow|PRISM B: Notebook Condition|"Telephone check-in calls and a notebook containing similar categories of information as the features on the PRISM C computer system such as a resource guide; games; classroom and information, calendar.~PRISM B: Notebook Condition: Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list."
217739|NCT01497613|O2|Outcome|PRISM C: Computer Condition|"A computer-based system designed to support socialization and access to resources; knowledge and prospective memory. The system is placed in the homes of those randomized to the condition for 12 months.~PRISM C: Computer Condition: A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory"
217740|NCT01497613|O1|Outcome|PRISM B: Notebook Condition|"Telephone check-in calls and a notebook containing similar categories of information as the features on the PRISM C computer system such as a resource guide; games; classroom and information, calendar.~PRISM B: Notebook Condition: Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list."
217741|NCT01497613|O2|Outcome|PRISM C: Computer Condition|"A computer-based system designed to support socialization and access to resources; knowledge and prospective memory. The system is placed in the homes of those randomized to the condition for 12 months.~PRISM C: Computer Condition: A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory"
217742|NCT01497613|O1|Outcome|PRISM B: Notebook Condition|"Telephone check-in calls and a notebook containing similar categories of information as the features on the PRISM C computer system such as a resource guide; games; classroom and information, calendar.~PRISM B: Notebook Condition: Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list."
217743|NCT01497613|O2|Outcome|PRISM C: Computer Condition|"A computer-based system designed to support socialization and access to resources; knowledge and prospective memory. The system is placed in the homes of those randomized to the condition for 12 months.~PRISM C: Computer Condition: A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory"
217744|NCT01497613|O1|Outcome|PRISM B: Notebook Condition|"Telephone check-in calls and a notebook containing similar categories of information as the features on the PRISM C computer system such as a resource guide; games; classroom and information, calendar.~PRISM B: Notebook Condition: Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list."
217745|NCT01497613|O2|Outcome|PRISM C: Computer Condition|"A computer-based system designed to support socialization and access to resources; knowledge and prospective memory. The system is placed in the homes of those randomized to the condition for 12 months.~PRISM C: Computer Condition: A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory"
217746|NCT01497613|O1|Outcome|PRISM B: Notebook Condition|"Telephone check-in calls and a notebook containing similar categories of information as the features on the PRISM C computer system such as a resource guide; games; classroom and information, calendar.~PRISM B: Notebook Condition: Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list."
217747|NCT01497613|O2|Outcome|PRISM C: Computer Condition|"A computer-based system designed to support socialization and access to resources; knowledge and prospective memory. The system is placed in the homes of those randomized to the condition for 12 months.~PRISM C: Computer Condition: A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory"
217748|NCT01497613|O1|Outcome|PRISM B: Notebook Condition|"Telephone check-in calls and a notebook containing similar categories of information as the features on the PRISM C computer system such as a resource guide; games; classroom and information, calendar.~PRISM B: Notebook Condition: Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list."
217749|NCT01497613|O2|Outcome|PRISM C: Computer Condition|"A computer-based system designed to support socialization and access to resources; knowledge and prospective memory. The system is placed in the homes of those randomized to the condition for 12 months.~PRISM C: Computer Condition: A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory"
217750|NCT01497613|O1|Outcome|PRISM B: Notebook Condition|"Telephone check-in calls and a notebook containing similar categories of information as the features on the PRISM C computer system such as a resource guide; games; classroom and information, calendar.~PRISM B: Notebook Condition: Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list."
217800|NCT01497262|O1|Outcome|Fingolimod 0.5 mg|Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
217801|NCT01497262|E1|Reported Event|Fingolimod 0.5 mg|Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
217802|NCT01497197|B3|Baseline|Total|Total of all reporting groups
217751|NCT01497613|O2|Outcome|PRISM C: Computer Condition|"A computer-based system designed to support socialization and access to resources; knowledge and prospective memory. The system is placed in the homes of those randomized to the condition for 12 months.~PRISM C: Computer Condition: A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory"
217752|NCT01497613|O1|Outcome|PRISM B: Notebook Condition|"Telephone check-in calls and a notebook containing similar categories of information as the features on the PRISM C computer system such as a resource guide; games; classroom and information, calendar.~PRISM B: Notebook Condition: Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list."
217753|NCT01497613|O2|Outcome|PRISM C: Computer Condition|"A computer-based system designed to support socialization and access to resources; knowledge and prospective memory. The system is placed in the homes of those randomized to the condition for 12 months.~PRISM C: Computer Condition: A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory"
217754|NCT01497613|O1|Outcome|PRISM B: Notebook Condition|"Telephone check-in calls and a notebook containing similar categories of information as the features on the PRISM C computer system such as a resource guide; games; classroom and information, calendar.~PRISM B: Notebook Condition: Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list."
217755|NCT01497613|O2|Outcome|PRISM C: Computer Condition|"A computer-based system designed to support socialization and access to resources; knowledge and prospective memory. The system is placed in the homes of those randomized to the condition for 12 months.~PRISM C: Computer Condition: A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory"
217756|NCT01497613|O1|Outcome|PRISM B: Notebook Condition|"Telephone check-in calls and a notebook containing similar categories of information as the features on the PRISM C computer system such as a resource guide; games; classroom and information, calendar.~PRISM B: Notebook Condition: Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list."
217757|NCT01497613|O2|Outcome|PRISM C: Computer Condition|"A computer-based system designed to support socialization and access to resources; knowledge and prospective memory. The system is placed in the homes of those randomized to the condition for 12 months.~PRISM C: Computer Condition: A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory"
217758|NCT01497613|O1|Outcome|PRISM B: Notebook Condition|"Telephone check-in calls and a notebook containing similar categories of information as the features on the PRISM C computer system such as a resource guide; games; classroom and information, calendar.~PRISM B: Notebook Condition: Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list."
217759|NCT01497613|O2|Outcome|PRISM C: Computer Condition|"A computer-based system designed to support socialization and access to resources; knowledge and prospective memory. The system is placed in the homes of those randomized to the condition for 12 months.~PRISM C: Computer Condition: A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory"
217760|NCT01497613|O1|Outcome|PRISM B: Notebook Condition|"Telephone check-in calls and a notebook containing similar categories of information as the features on the PRISM C computer system such as a resource guide; games; classroom and information, calendar.~PRISM B: Notebook Condition: Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list."
217761|NCT01497613|O2|Outcome|PRISM C: Computer Condition|"A computer-based system designed to support socialization and access to resources; knowledge and prospective memory. The system is placed in the homes of those randomized to the condition for 12 months.~PRISM C: Computer Condition: A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory"
217762|NCT01497613|O1|Outcome|PRISM B: Notebook Condition|"Telephone check-in calls and a notebook containing similar categories of information as the features on the PRISM C computer system such as a resource guide; games; classroom and information, calendar.~PRISM B: Notebook Condition: Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list."
217763|NCT01497613|O2|Outcome|PRISM C: Computer Condition|"A computer-based system designed to support socialization and access to resources; knowledge and prospective memory. The system is placed in the homes of those randomized to the condition for 12 months.~PRISM C: Computer Condition: A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory"
217764|NCT01497613|O1|Outcome|PRISM B: Notebook Condition|"Telephone check-in calls and a notebook containing similar categories of information as the features on the PRISM C computer system such as a resource guide; games; classroom and information, calendar.~PRISM B: Notebook Condition: Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list."
217765|NCT01497613|O2|Outcome|PRISM C: Computer Condition|"A computer-based system designed to support socialization and access to resources; knowledge and prospective memory. The system is placed in the homes of those randomized to the condition for 12 months.~PRISM C: Computer Condition: A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory"
217766|NCT01497613|O1|Outcome|PRISM B: Notebook Condition|"Telephone check-in calls and a notebook containing similar categories of information as the features on the PRISM C computer system such as a resource guide; games; classroom and information, calendar.~PRISM B: Notebook Condition: Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list."
217767|NCT01497613|E2|Reported Event|PRISM C: Computer Condition|"A computer-based system designed to support socialization and access to resources; knowledge and prospective memory. The system is placed in the homes of those randomized to the condition for 12 months.~PRISM C: Computer Condition: A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory"
217878|NCT01496469|O1|Outcome|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
217768|NCT01497613|E1|Reported Event|PRISM B: Notebook Condition|"Telephone check-in calls and a notebook containing similar categories of information as the features on the PRISM C computer system such as a resource guide; games; classroom and information, calendar.~PRISM B: Notebook Condition: Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list."
217769|NCT01497366|B3|Baseline|Total|Total of all reporting groups
217770|NCT01497366|B2|Baseline|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
217771|NCT01497366|B1|Baseline|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
217772|NCT01497366|P2|Participant Flow|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
217773|NCT01497366|P1|Participant Flow|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+ribavirin (RBV) for 12 weeks.
217774|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
217775|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
217776|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
217777|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
217778|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
217779|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir (SOF)+RBV for 12 weeks.
217780|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
217781|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir (SOF)+RBV for 12 weeks.
217782|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
217783|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
217784|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
217785|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
217786|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
217787|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
217788|NCT01497366|E2|Reported Event|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
217789|NCT01497366|E1|Reported Event|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
217790|NCT01497275|B1|Baseline|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
217791|NCT01497275|P1|Participant Flow|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
217792|NCT01497275|O1|Outcome|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
217793|NCT01497275|O1|Outcome|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
217794|NCT01497275|O1|Outcome|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
217795|NCT01497275|O1|Outcome|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
217796|NCT01497275|E1|Reported Event|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
217797|NCT01497262|B1|Baseline|Fingolimod 0.5 mg|Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
217798|NCT01497262|P1|Participant Flow|Fingolimod 0.5 mg|Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
217799|NCT01497262|O1|Outcome|Fingolimod 0.5 mg|Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
217803|NCT01497197|B2|Baseline|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
217804|NCT01497197|B1|Baseline|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
217805|NCT01497197|P2|Participant Flow|Gonal-f® Followed by Luveris|GONAL-f® (Liquid Pen; 300 IU per day) stimulation Day 1-5 then added Luveris® (vial/powder, 150 IU per day) from stimulation day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject’s ovarian response and according to the centre's standard practice.
217806|NCT01497197|P1|Participant Flow|Gonal-f®+Luveris|GONAL f® (Liquid Pen; 300 international units [IU] of per day) stimulation Day 1-5 then followed by Luveris® (vial/powder, 150 IU per day) from stimulation Day 1 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject’s ovarian response and according to the centre's standard practice.
217807|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
217808|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
217809|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
217810|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
217811|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
217812|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
217813|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
217814|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
217815|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
217816|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
217817|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
217818|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
217819|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
217820|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
217821|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
217822|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
217823|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
217824|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
217825|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
217826|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
217827|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
217828|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
217829|NCT01497197|E2|Reported Event|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
217830|NCT01497197|E1|Reported Event|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
217831|NCT01497171|B3|Baseline|Total|Total of all reporting groups
217832|NCT01497171|B2|Baseline|Anterior Colporrhaphy|Traditional suture repair of anterior vaginal prolapse
217833|NCT01497171|B1|Baseline|Elevate Mesh|Transvaginal mesh repair of anterior vaginal prolapse
217834|NCT01497171|P2|Participant Flow|Anterior Colporrhaphy|"Anterior colporrhaphy - surgical repair of prolapse~Anterior Colporrhaphy: Traditional suture repair of anterior vaginal prolapse"
217835|NCT01497171|P1|Participant Flow|Elevate Mesh|"Elevate transvaginal mesh - surgical repair of prolapse~Elevate Mesh: Transvaginal mesh repair of anterior vaginal prolapse"
217836|NCT01497171|O2|Outcome|Anterior Colporrhaphy|"Anterior colporrhaphy - surgical repair of prolapse~Anterior Colporrhaphy: Traditional suture repair of anterior vaginal prolapse"
217837|NCT01497171|O1|Outcome|Elevate Mesh|"Elevate transvaginal mesh - surgical repair of prolapse~Elevate Mesh: Transvaginal mesh repair of anterior vaginal prolapse"
217838|NCT01497171|E2|Reported Event|Anterior Colporrhaphy|"Anterior colporrhaphy - surgical repair of prolapse~Anterior Colporrhaphy: Traditional suture repair of anterior vaginal prolapse"
217839|NCT01497171|E1|Reported Event|Elevate Mesh|"Elevate transvaginal mesh - surgical repair of prolapse~Elevate Mesh: Transvaginal mesh repair of anterior vaginal prolapse"
217840|NCT01496846|B7|Baseline|Total|Total of all reporting groups
217841|NCT01496846|B6|Baseline|IANB Articaine and SUP Lidocaine - 2nd Molar|Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic provided to 2nd Molar after unsuccessful IANB.
217842|NCT01496846|B5|Baseline|IANB Articaine and SUP Lidocaine - 1st Molar|Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic provided to 1st Molar after unsuccessful IANB.
217843|NCT01496846|B4|Baseline|IANB Articaine and SUP Articaine - 2nd Molar|Supplemental buccal anesthesia (SUP) with articaine local anesthetic provided to 2nd Molar after unsuccessful IANB.
217844|NCT01496846|B3|Baseline|IANB Articaine and SUP Articaine - 1st Molar|Supplemental buccal anesthesia (SUP) with articaine local anesthetic provided to 1st Molar after unsuccessful IANB.
217845|NCT01496846|B2|Baseline|IANB Articaine Only - 2nd Molar|IANB anesthesia with articaine local anesthetic provided to 2nd Molar
217846|NCT01496846|B1|Baseline|IANB Articaine Only - 1st Molar|IANB anesthesia with articaine local anesthetic provided to 1st Molar
217847|NCT01496846|P6|Participant Flow|IANB Articaine and SUP Lidocaine - 2nd Molar|Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic provided to 2nd Molar after unsuccessful IANB.
217848|NCT01496846|P5|Participant Flow|IANB Articaine and SUP Lidocaine - 1st Molar|Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic provided to 1st Molar after unsuccessful IANB.
217849|NCT01496846|P4|Participant Flow|IANB Articaine and SUP Articaine - 2nd Molar|Supplemental buccal anesthesia (SUP) with articaine local anesthetic provided to 2nd Molar after unsuccessful IANB.
217850|NCT01496846|P3|Participant Flow|IANB Articaine and SUP Articaine - 1st Molar|Supplemental buccal anesthesia (SUP) with articaine local anesthetic provided to 1st Molar after unsuccessful IANB.
217851|NCT01496846|P2|Participant Flow|IANB Articaine Only - 2nd Molar|IANB anesthesia with articaine local anesthetic provided to 2nd Molar.
217852|NCT01496846|P1|Participant Flow|IANB Articaine Only - 1st Molar|IANB anesthesia with articaine local anesthetic provided to 1st Molar.
217853|NCT01496846|O2|Outcome|IANB Articaine - 2nd Molar|Initial IANB (1.7cc 4% articaine with 1:100,000 epinephrine) provided to 2nd Molar.
217854|NCT01496846|O1|Outcome|IANB Articaine - 1st Molar|Initial IANB (1.7cc 4% articaine with 1:100,000 epinephrine) provided to 1st Molar.
217855|NCT01496846|O4|Outcome|IANB Articaine and SUP Lidocaine - 2nd Molar|Supplemental buccal anesthesia with lidocaine local anesthetic provided to 2nd Molar after unsuccessful IANB.
217856|NCT01496846|O3|Outcome|IANB Articaine and SUP Lidocaine - 1st Molar|Supplemental buccal anesthesia with lidocaine local anesthetic provided to 1st Molar after unsuccessful IANB.
217857|NCT01496846|O2|Outcome|IANB Articaine and SUP Articaine - 2nd Molar|Supplemental buccal anesthesia with articaine local anesthetic provided to 2nd Molar after unsuccessful IANB.
217858|NCT01496846|O1|Outcome|IANB Articaine and SUP Articaine - 1st Molar|Supplemental buccal anesthesia with articaine local anesthetic provided to 1st Molar after unsuccessful IANB.
217859|NCT01496846|E3|Reported Event|SUP Lidocaine|Supplemental buccal anesthesia with lidocaine local anesthetic.
217860|NCT01496846|E2|Reported Event|SUP Articaine|Supplemental buccal anesthesia with articaine local anesthetic.
217861|NCT01496846|E1|Reported Event|Initial IANB Articaine|Initial IANB with articaine local anesthetic.
217862|NCT01496807|B1|Baseline|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
217863|NCT01496807|P1|Participant Flow|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
217864|NCT01496807|O1|Outcome|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
217865|NCT01496807|O1|Outcome|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
217866|NCT01496807|O1|Outcome|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
217867|NCT01496807|O1|Outcome|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
217868|NCT01496807|O1|Outcome|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
217869|NCT01496807|O1|Outcome|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
217870|NCT01496807|O1|Outcome|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
217871|NCT01496807|E1|Reported Event|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
217872|NCT01496469|B3|Baseline|Total|Total of all reporting groups
217873|NCT01496469|B2|Baseline|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
217874|NCT01496469|B1|Baseline|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
217875|NCT01496469|P2|Participant Flow|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
217876|NCT01496469|P1|Participant Flow|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
217877|NCT01496469|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
217879|NCT01496469|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
217880|NCT01496469|O1|Outcome|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
217881|NCT01496469|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
217882|NCT01496469|O1|Outcome|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
217883|NCT01496469|E2|Reported Event|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
217884|NCT01496469|E1|Reported Event|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
217885|NCT01496456|B1|Baseline|Lesion Infiltration and Preventative Management Only|"Paired split-mouth study: both arms in same patient (2 study teeth). A) Resin infiltration therapy in addition to preventative caries management B) Preventative caries management only~SOC Baseline preventative caries management: dietary and behavioral modification, and OTC fluoride supplements"
217886|NCT01496456|P1|Participant Flow|Lesion Infiltration and Preventative Management Only|"Paired split-mouth study: both arms (arm A and arm B) were applied in same patient (2 study teeth).~A) Resin infiltration therapy in addition to SOC Preventative caries management B) SOC Preventative caries management only.~––– Standard Of Care (SOC) Baseline preventative caries management included dietary and behavioral modification, and over-the-counter (OTC) fluoride supplements."
217887|NCT01496456|O2|Outcome|Preventative Measures|"Caries management by preventative measures only: oral hygiene instruction, diet counseling and fluoride supplementation~Baseline SOC preventative caries management: dietary and behavioral modification, and OTC-fluoride supplements"
217888|NCT01496456|O1|Outcome|Lesion Infiltration|Resin infiltration of caries lesion in addition to SOC caries management by preventative measures.
217889|NCT01496456|O2|Outcome|Preventative Measures|"Caries management by preventative measures only: oral hygiene instruction, diet counseling and fluoride supplementation~Baseline SOC preventative caries management: dietary and behavioral modification, and OTC-fluoride supplements"
217890|NCT01496456|O1|Outcome|Lesion Infiltration|Resin infiltration of caries lesion in addition to SOC caries management by preventative measures.
217891|NCT01496456|O2|Outcome|Preventative Measures|SOC Caries management by preventative measures only.
217892|NCT01496456|O1|Outcome|Lesion Infiltration|Resin infiltration of caries lesion in addition to SOC caries management by preventative measures.
217893|NCT01496456|E2|Reported Event|Preventative Measures|"Caries management by preventative measures only~SOC Baseline preventative caries management: dietary and behavioral modification, and OTC-fluoride supplements"
217894|NCT01496456|E1|Reported Event|Lesion Infiltration|"Resin infiltration of caries lesion in addition to SOC caries management by preventative measures~SOC Baseline preventative caries management: dietary and behavioral modification, and OTC-fluoride supplements"
217895|NCT01496430|B4|Baseline|Total|Total of all reporting groups
217896|NCT01496430|B3|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
217897|NCT01496430|B2|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
217898|NCT01496430|B1|Baseline|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
217899|NCT01496430|P3|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
217900|NCT01496430|P2|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
217901|NCT01496430|P1|Participant Flow|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
217902|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
217903|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
217904|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
217905|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
217906|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
217907|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
217908|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
217909|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
217910|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
217911|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
217912|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
217913|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
217914|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
217915|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
217916|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
217917|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
217918|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
217919|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
217920|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
217921|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
217922|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
217923|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
217924|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
217925|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
217926|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
217927|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
217928|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
217929|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
217930|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
217931|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
217932|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
217933|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
217934|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
217935|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
217936|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
217937|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
217938|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
217939|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
217940|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
217941|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
217942|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
217943|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
217944|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
217945|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
217946|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
217947|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
217948|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
217949|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
217950|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
217951|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
217952|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
217953|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
217954|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
217955|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
217956|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
217957|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
217958|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
217959|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
217960|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
217961|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
217962|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
217963|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
217964|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
217965|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
217966|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
217967|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
217968|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
217969|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
217970|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
217971|NCT01496430|E3|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
217972|NCT01496430|E2|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
217973|NCT01496430|E1|Reported Event|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
217974|NCT01496352|B3|Baseline|Total|Total of all reporting groups
217975|NCT01496352|B2|Baseline|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02 placebo
217976|NCT01496352|B1|Baseline|DFA-02|Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02
217977|NCT01496352|P2|Participant Flow|DFA-02 Placebo|Progressive cohorts of 2 patients per cohort receiving up to 10, 20 or 30 mL of DFA-02 placebo
217978|NCT01496352|P1|Participant Flow|DFA-02|"Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02~DFA-02: Modified release product containing gentamicin and vancomycin for application at the conclusion of surgery after closure of the fascia and prior to skin closure"
217979|NCT01496352|O2|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 or 30 mL DFA-02 placebo
217980|NCT01496352|O1|Outcome|DFA-02|Progressive cohorts of 8 subjects receiving up to 10, 20 or 30 mL DFA-02
217981|NCT01496352|O2|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subject per cohort receiving up to 10, 20 or 30 mL DFA-02 placebo
217982|NCT01496352|O1|Outcome|DFA-02|Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL DFA-02
217983|NCT01496352|O2|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving 10, 20 or 30 mL DFA-02 placebo
217984|NCT01496352|O1|Outcome|DFA-02|Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL DFA-02
217985|NCT01496352|O2|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 and 30 mL of DFA-02 placebo
217986|NCT01496352|O1|Outcome|DFA-02|Progressive cohorts of 18 subjects receiving up to 10, 20 or 30 mL of DFA-02
217987|NCT01496352|O2|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02 placebo
217988|NCT01496352|O1|Outcome|DFA-02|Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02
217989|NCT01496352|O2|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subjects receiving 10, 20 or 30 mL of DFA-02 placebo
217990|NCT01496352|O1|Outcome|DFA-02|Progressive cohorts of 8 subjects receiving up to 10, 20 or 30 mL of DFA-02
217991|NCT01496352|E2|Reported Event|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02 placebo
217992|NCT01496352|E1|Reported Event|DFA-02|Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02
217993|NCT01496313|B3|Baseline|Total|Total of all reporting groups
217994|NCT01496313|B2|Baseline|Vandetanib 300 mg|Oral blinded tablet, taken once daily
217995|NCT01496313|B1|Baseline|Vandetanib 150 mg|Oral blinded tablet, taken once daily
217996|NCT01496313|P2|Participant Flow|Vandetanib 300 mg|Oral blinded tablet, taken once daily
217997|NCT01496313|P1|Participant Flow|Vandetanib 150 mg|Oral blinded tablet, taken once daily
217998|NCT01496313|O2|Outcome|Vandetanib 300 mg|Oral blinded tablet, taken once daily
217999|NCT01496313|O1|Outcome|Vandetanib 150 mg|Oral blinded tablet, taken once daily
218000|NCT01496313|O2|Outcome|Vandetanib 300 mg|Oral blinded tablet, taken once daily
218001|NCT01496313|O1|Outcome|Vandetanib 150 mg|Oral blinded tablet, taken once daily
218002|NCT01496313|O2|Outcome|Vandetanib 300 mg|Oral blinded tablet, taken once daily
218003|NCT01496313|O1|Outcome|Vandetanib 150 mg|Oral blinded tablet, taken once daily
218004|NCT01496313|O2|Outcome|Vandetanib 300 mg|Oral blinded tablet, taken once daily
218005|NCT01496313|O1|Outcome|Vandetanib 150 mg|Oral blinded tablet, taken once daily
218006|NCT01496313|O2|Outcome|Vandetanib 300 mg|Oral blinded tablet, taken once daily
218007|NCT01496313|O1|Outcome|Vandetanib 150 mg|Oral blinded tablet, taken once daily
218008|NCT01496313|O2|Outcome|Vandetanib 300 mg|Oral blinded tablet, taken once daily
218009|NCT01496313|O1|Outcome|Vandetanib 150 mg|Oral blinded tablet, taken once daily
218010|NCT01496313|E2|Reported Event|Vandetanib 300 mg|Oral blinded tablet, taken once daily
218011|NCT01496313|E1|Reported Event|Vandetanib 150 mg|Oral blinded tablet, taken once daily
218012|NCT01496287|B1|Baseline|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
218013|NCT01496287|P1|Participant Flow|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
218014|NCT01496287|O1|Outcome|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
218015|NCT01496287|O1|Outcome|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
218016|NCT01496287|O1|Outcome|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
218017|NCT01496287|O1|Outcome|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the tympanostomy tube delivery system under local anesthesia in an office/clinic setting
218018|NCT01496287|O1|Outcome|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the tympanostomy tube delivery system under local anesthesia in an office/clinic setting
218019|NCT01496287|E1|Reported Event|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
218020|NCT01496274|B3|Baseline|Total|Total of all reporting groups
218048|NCT01496274|O2|Outcome|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
218021|NCT01496274|B2|Baseline|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.~rIX-FP: Recombinant IX-FP (rIX-FP) is a fusion protein linking coagulation factor IX with albumin, and will be administered by intravenous administration"
218022|NCT01496274|B1|Baseline|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.~rIX-FP: Recombinant IX-FP (rIX-FP) is a fusion protein linking coagulation factor IX with albumin, and will be administered by intravenous administration"
218023|NCT01496274|P2|Participant Flow|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
218024|NCT01496274|P1|Participant Flow|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
218025|NCT01496274|O3|Outcome|Prophylaxis Arm, 14-day Regimen|Subjects received prophylactic rIX-FP every 14 days.
218026|NCT01496274|O2|Outcome|Prophylaxis Arm, 10-day Regimen|Subjects received prophylactic rIX-FP every 10 days.
218027|NCT01496274|O1|Outcome|Prophylaxis Arm, 7-day Regimen|Subjects received prophylactic rIX-FP on a weekly basis.
218028|NCT01496274|O1|Outcome|Surgical Population|The Surgical population consisted of 3 subjects in the prophylaxis arm and 1 subject in the on demand arm who received at least 1 dose of rIX FP for a major or minor surgical procedure.
218029|NCT01496274|O2|Outcome|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
218030|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
218031|NCT01496274|O2|Outcome|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
218032|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
218033|NCT01496274|O2|Outcome|On-demand|"Episodic treatment for bleeding episodes up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
218034|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
218035|NCT01496274|O2|Outcome|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
218036|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
218037|NCT01496274|O4|Outcome|Prophylaxis Arm, 14-day Regimen|Subjects received prophylactic rIX-FP every 14 days.
218038|NCT01496274|O3|Outcome|Prophylaxis Arm, 10-day Regimen|Subjects received prophylactic rIX-FP every 10 days.
218039|NCT01496274|O2|Outcome|Prophylaxis Arm, 7-day Regimen|Subjects received prophylactic rIX-FP on a weekly basis.
218040|NCT01496274|O1|Outcome|On-demand Arm, Prophylaxis Regimen|Participants in the On-demand Arm, when receiving routine weekly prophylaxis (prophylaxis regimen).
218041|NCT01496274|O2|Outcome|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
218042|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
218043|NCT01496274|O3|Outcome|On-demand Arm, Prophylaxis Regimen|Participants in the On-demand Arm, when receiving routine weekly prophylaxis (prophylaxis regimen).
218044|NCT01496274|O2|Outcome|On-demand Arm, On-demand Regimen|Participants in the On-demand Arm, when receiving episodic treatment for bleeding episodes (on-demand regimen).
218045|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
218046|NCT01496274|O1|Outcome|Safety Population|The Safety population consisted of subjects who received at least 1 dose of rIX-FP during the study.
218047|NCT01496274|O3|Outcome|Safety Population|The Safety population consisted of subjects who received at least 1 dose of rIX-FP during the study.
218109|NCT01496066|O1|Outcome|Light Adjustable Lens Implanted|Randomized to have the Light Adjustable Lens implanted
218049|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
218050|NCT01496274|O1|Outcome|Safety Population|The Safety population consisted of subjects who received at least 1 dose of rIX-FP during the study.
218051|NCT01496274|O2|Outcome|On-demand Arm, Prophylaxis Regimen|Participants in the On-demand Arm, when receiving routine weekly prophylaxis (prophylaxis regimen).
218052|NCT01496274|O1|Outcome|On-demand Arm, On-demand Regimen|Participants in the On-demand Arm, when receiving episodic treatment for bleeding episodes (on-demand regimen).
218053|NCT01496274|E2|Reported Event|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
218054|NCT01496274|E1|Reported Event|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
218055|NCT01496248|B1|Baseline|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
218056|NCT01496248|P1|Participant Flow|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
218057|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
218058|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
218059|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
218060|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
218061|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
218062|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
218063|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
218064|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
218065|NCT01496248|E1|Reported Event|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
218066|NCT01496183|B3|Baseline|Total|Total of all reporting groups
218067|NCT01496183|B2|Baseline|Olanzapine|Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
218068|NCT01496183|B1|Baseline|Placebo|Placebo: Placebo capsule administered orally at bedtime for 14 days
218069|NCT01496183|P2|Participant Flow|Olanzapine|Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
218070|NCT01496183|P1|Participant Flow|Placebo|Placebo: Placebo capsule administered orally at bedtime for 14 days
218071|NCT01496183|O2|Outcome|Olanzapine|Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
218072|NCT01496183|O1|Outcome|Placebo|Placebo: Placebo capsule administered orally at bedtime for 14 days Six subjects from the placebo group completed the 2-week double-blind trial and were included in the analysis.
218073|NCT01496183|E2|Reported Event|Olanzapine|Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
218074|NCT01496183|E1|Reported Event|Placebo|Placebo: Placebo capsule administered orally at bedtime for 14 days
218075|NCT01496131|B3|Baseline|Total|Total of all reporting groups
218076|NCT01496131|B2|Baseline|Standard Therapy Plus Tecemotide (L-BLP25)|Subjects received Goserelin 10.8 mg subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after ADT. In addition to the above standard treatment, subjects received tecemotide at a dose of 918 microgram (mcg) as subcutaneous injections every 2 weeks for 2 months followed by continuation treatment with 4 doses of tecemotide every 6 weeks. Subjects also received a single dose of cyclophosphamide 300 mg per square meter intra-venously 3 days before 1st administration of tecemotide.
218077|NCT01496131|B1|Baseline|Standard Therapy|Subjects received Goserelin 10.8 milligrams (mg) subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after ADT.
218110|NCT01496066|E2|Reported Event|Monofocal Control IOL|Randomized to have the Monofocal control IOL implanted
218078|NCT01496131|P2|Participant Flow|Standard Therapy Plus Tecemotide (L-BLP25)|Subjects received Goserelin 10.8 mg subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after ADT. In addition to the above standard treatment, subjects received tecemotide at a dose of 918 microgram (mcg) as subcutaneous injections every 2 weeks for 2 months followed by continuation treatment with 4 doses of tecemotide every 6 weeks. Subjects also received a single dose of cyclophosphamide 300 mg per square meter intra-venously 3 days before 1st administration of tecemotide.
218079|NCT01496131|P1|Participant Flow|Standard Therapy|Subjects received Goserelin 10.8 milligrams (mg) subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after Androgen Deprivation Therapy (ADT).
218080|NCT01496131|O2|Outcome|Standard Therapy Plus Tecemotide (L-BLP25)|Subjects received Goserelin 10.8 mg subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after ADT. In addition to the above standard treatment, subjects received tecemotide at a dose of 918 microgram (mcg) as subcutaneous injections every 2 weeks for 2 months followed by continuation treatment with 4 doses of tecemotide every 6 weeks. Subjects also received a single dose of cyclophosphamide 300 mg per square meter intra-venously 3 days before 1st administration of tecemotide.
218081|NCT01496131|O1|Outcome|Standard Therapy|Subjects received Goserelin 10.8 milligrams (mg) subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after ADT.
218082|NCT01496131|O2|Outcome|Standard Therapy Plus Tecemotide (L-BLP25)|Subjects received Goserelin 10.8 mg subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after ADT. In addition to the above standard treatment, subjects received tecemotide at a dose of 918 microgram (mcg) as subcutaneous injections every 2 weeks for 2 months followed by continuation treatment with 4 doses of tecemotide every 6 weeks. Subjects also received a single dose of cyclophosphamide 300 mg per square meter intra-venously 3 days before 1st administration of tecemotide.
218083|NCT01496131|O1|Outcome|Standard Therapy|Subjects received Goserelin 10.8 milligrams (mg) subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after ADT.
218084|NCT01496131|O2|Outcome|Standard Therapy Plus Tecemotide (L-BLP25)|Subjects received Goserelin 10.8 mg subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after ADT. In addition to the above standard treatment, subjects received tecemotide at a dose of 918 microgram (mcg) as subcutaneous injections every 2 weeks for 2 months followed by continuation treatment with 4 doses of tecemotide every 6 weeks. Subjects also received a single dose of cyclophosphamide 300 mg per square meter intra-venously 3 days before 1st administration of tecemotide.
218085|NCT01496131|O1|Outcome|Standard Therapy|Subjects received Goserelin 10.8 milligrams (mg) subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after ADT.
218086|NCT01496131|O2|Outcome|Standard Therapy Plus Tecemotide (L-BLP25)|Subjects received Goserelin 10.8 mg subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after ADT. In addition to the above standard treatment, subjects received tecemotide at a dose of 918 microgram (mcg) as subcutaneous injections every 2 weeks for 2 months followed by continuation treatment with 4 doses of tecemotide every 6 weeks. Subjects also received a single dose of cyclophosphamide 300 mg per square meter intra-venously 3 days before 1st administration of tecemotide.
218087|NCT01496131|O1|Outcome|Standard Therapy|Subjects received Goserelin 10.8 milligrams (mg) subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after ADT.
218088|NCT01496131|E2|Reported Event|Standard Therapy Plus Tecemotide (L-BLP25)|Subjects received Goserelin 10.8 mg subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after ADT. In addition to the above standard treatment, subjects received tecemotide at a dose of 918 microgram (mcg) as subcutaneous injections every 2 weeks for 2 months followed by continuation treatment with 4 doses of tecemotide every 6 weeks. Subjects also received a single dose of cyclophosphamide 300 mg per square meter intra-venously 3 days before 1st administration of tecemotide.
218089|NCT01496131|E1|Reported Event|Standard Therapy|Subjects received Goserelin 10.8 milligrams (mg) subcutaneously every 3 months for 2 years and radiation therapy lasting 6-8 weeks starting 2-3 months after ADT.
218090|NCT01496066|B3|Baseline|Total|Total of all reporting groups
218091|NCT01496066|B2|Baseline|Monofocal Control|"Monofocal control IOL implanted~Monofocal control IOL: Commercially available monofocal intraocular lens (IOL)"
218092|NCT01496066|B1|Baseline|LAL Implant|"LAL implanted~LAL (Light Adjustable Lens) and Light Deliver Device (LDD): LAL implanted and adjusted with LDD"
218093|NCT01496066|P2|Participant Flow|Monofocal Control|"Monofocal control IOL implanted~Monofocal control IOL: Commercially available monofocal intraocular lens (IOL)"
218094|NCT01496066|P1|Participant Flow|LAL Implant|"LAL implanted~LAL (Light Adjustable Lens) and Light Deliver Device (LDD): LAL implanted and adjusted with LDD"
218095|NCT01496066|O2|Outcome|Monofocal Control IOL|Randomized to have the Monofocal control IOL implanted
218096|NCT01496066|O1|Outcome|Light Adjustable Lens|Randomized to have the Light Adjustable Lens implanted
218097|NCT01496066|O2|Outcome|Monofocal Control IOL|Randomized to have the monofocal control IOL implanted
218098|NCT01496066|O1|Outcome|Light Adjustable Lens|Randomized to have the Light Adjustable Lens implanted
218099|NCT01496066|O2|Outcome|Monofocal Control IOL|Randomized to have the monofocal control IOL implanted
218100|NCT01496066|O1|Outcome|Light Adjustable Lens|Randomized to have the Light Adjustable Lens implanted
218101|NCT01496066|O2|Outcome|Monofocal Control IOL|Randomized to have the monofocal control IOL implanted
218102|NCT01496066|O1|Outcome|Light Adjustable Lens|Randomized to have the Light Adjustable Lens implanted
218103|NCT01496066|O2|Outcome|Monofocal Control IOL|Randomized to have a Monofocal control IOL implanted
218104|NCT01496066|O1|Outcome|Light Adjustable Lens|Randomized to have the Light Adjustable Lens implanted
218105|NCT01496066|O1|Outcome|Light Adjustable Lens|Eyes randomized to be implanted with the Light Adjustable Lens
218106|NCT01496066|O2|Outcome|Monofocal Control IOL|Eyes randomized to have monofocal control IOL implanted
218107|NCT01496066|O1|Outcome|Light Adjustable Lens|Eyes randomized to have Light Adjustable Lens implanted
218108|NCT01496066|O2|Outcome|Control IOL Implanted|Randomized to have the monofocal control IOL implanted
218111|NCT01496066|E1|Reported Event|Light Adjustable Lens|Randomized to have the Light Adjustable Lens implanted
218112|NCT01495988|B5|Baseline|Total|Total of all reporting groups
218113|NCT01495988|B4|Baseline|Vemurafenib + Bevacizumab|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
218114|NCT01495988|B3|Baseline|Vemurafenib|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
218115|NCT01495988|B2|Baseline|Vemurafenib/Cobimetinib + Bevacizumab|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
218116|NCT01495988|B1|Baseline|Vemurafenib/Cobimetinib|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
218117|NCT01495988|P4|Participant Flow|Vemurafenib + Bevacizumab|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
218118|NCT01495988|P3|Participant Flow|Vemurafenib|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
218119|NCT01495988|P2|Participant Flow|Vemurafenib/Cobimetinib + Bevacizumab|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
218120|NCT01495988|P1|Participant Flow|Vemurafenib/Cobimetinib|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
218121|NCT01495988|O4|Outcome|Vemurafenib + Bevacizumab|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
218122|NCT01495988|O3|Outcome|Vemurafenib|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
218123|NCT01495988|O2|Outcome|Vemurafenib/Cobimetinib + Bevacizumab|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
218124|NCT01495988|O1|Outcome|Vemurafenib/Cobimetinib|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
218125|NCT01495988|O4|Outcome|Vemurafenib + Bevacizumab|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
218126|NCT01495988|O3|Outcome|Vemurafenib|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
218155|NCT01495975|B1|Baseline|Usual Care|Usual care for diabetes in the 1 month after discharge.
218127|NCT01495988|O2|Outcome|Vemurafenib/Cobimetinib + Bevacizumab|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
218128|NCT01495988|O1|Outcome|Vemurafenib/Cobimetinib|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
218129|NCT01495988|O4|Outcome|Vemurafenib + Bevacizumab|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
218130|NCT01495988|O3|Outcome|Vemurafenib|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
218131|NCT01495988|O2|Outcome|Vemurafenib/Cobimetinib + Bevacizumab|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
218132|NCT01495988|O1|Outcome|Vemurafenib/Cobimetinib|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
218133|NCT01495988|O4|Outcome|Vemurafenib + Bevacizumab|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
218134|NCT01495988|O3|Outcome|Vemurafenib|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
218135|NCT01495988|O2|Outcome|Vemurafenib/Cobimetinib + Bevacizumab|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
218136|NCT01495988|O1|Outcome|Vemurafenib/Cobimetinib|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
218137|NCT01495988|O4|Outcome|Vemurafenib + Bevacizumab|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
218138|NCT01495988|O3|Outcome|Vemurafenib|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
218139|NCT01495988|O2|Outcome|Vemurafenib/Cobimetinib + Bevacizumab|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
218156|NCT01495975|P2|Participant Flow|Diabetes Transitions Tool Kit|"Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge.~Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge."
218140|NCT01495988|O1|Outcome|Vemurafenib/Cobimetinib|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
218141|NCT01495988|O4|Outcome|Vemurafenib + Bevacizumab|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
218142|NCT01495988|O3|Outcome|Vemurafenib|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
218143|NCT01495988|O2|Outcome|Vemurafenib/Cobimetinib + Bevacizumab|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
218144|NCT01495988|O1|Outcome|Vemurafenib/Cobimetinib|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
218145|NCT01495988|O4|Outcome|Vemurafenib + Bevacizumab|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
218146|NCT01495988|O3|Outcome|Vemurafenib|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
218147|NCT01495988|O2|Outcome|Vemurafenib/Cobimetinib + Bevacizumab|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
218148|NCT01495988|O1|Outcome|Vemurafenib/Cobimetinib|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
218149|NCT01495988|E4|Reported Event|Vemurafenib + Bevacizumab|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
218150|NCT01495988|E3|Reported Event|Vemurafenib|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.~Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
218151|NCT01495988|E2|Reported Event|Vemurafenib/Cobimetinib + Bevacizumab|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
218152|NCT01495988|E1|Reported Event|Vemurafenib/Cobimetinib|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.~Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.~Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
218153|NCT01495975|B3|Baseline|Total|Total of all reporting groups
218154|NCT01495975|B2|Baseline|Diabetes Transitions Tool Kit|"Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge.~Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge."
218157|NCT01495975|P1|Participant Flow|Usual Care|Usual care for diabetes in the 1 month after discharge.
218158|NCT01495975|O2|Outcome|Diabetes Transitions Tool Kit|"Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge.~Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge."
218159|NCT01495975|O1|Outcome|Usual Care|Usual care for diabetes in the 1 month after discharge.
218160|NCT01495975|E2|Reported Event|Diabetes Transitions Tool Kit|"Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge.~Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge."
218161|NCT01495975|E1|Reported Event|Usual Care|Usual care for diabetes in the 1 month after discharge.
218162|NCT01495923|B3|Baseline|Total|Total of all reporting groups
218163|NCT01495923|B2|Baseline|Gabapentin|Participants that had lumbosacral radicular pain secondary to herniated disc or spinal stenosis who receive real gabapentin and a placebo injection as treatment.
218164|NCT01495923|B1|Baseline|Epidural Steriod Injections|Participants that had lumbosacral radicular pain secondary to herniated disc or spinal stenosis who receive a real epidural steroid injection and placebo medication as treatment.
218165|NCT01495923|P2|Participant Flow|Gabapentin|If randomized to this group participants received gabapentin medication and a placebo intramuscular injection. The gabapentin was uptitrated to a therapeutic dose using a titration schedule.
218166|NCT01495923|P1|Participant Flow|Epidural Steroid Injection|If randomized to this group, participants received either a transforaminal injection for unilateral pain or an interlaminar injection for bilateral pain and placebo medication. The level and type of injection to be given was determined by signs, symptoms, and radiological findings.
218167|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
218168|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
218169|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
218170|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
218171|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
218172|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
218173|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
218174|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
218175|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
218176|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
218177|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
218178|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
218179|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
218180|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
218181|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
218182|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
218183|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
218184|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
218185|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
218186|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
218187|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
218188|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
218189|NCT01495923|O2|Outcome|Epidural Steroid|This group received an epidural steroid injection and placebo gabapentin.
218190|NCT01495923|O1|Outcome|Gabapentin Group|This group received gabapentin and a placebo intramuscular injection.
218191|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
218192|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
218193|NCT01495923|E2|Reported Event|Gabapentin|"Titration of gabapentin to effect~Sham epidural steroid injection: Injection of saline into the back muscles~Gabapentin: Titration of gabapentin to effect"
218194|NCT01495923|E1|Reported Event|Epidural Steroids|"Injection of steroids into the epidural space~epidural steroid injection: Injection of steroids and local anesthetic into the epidural space~Placebo gabapentin: Titration of placebo gabapentin"
218195|NCT01495858|B4|Baseline|Total|Total of all reporting groups
218196|NCT01495858|B3|Baseline|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218197|NCT01495858|B2|Baseline|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218198|NCT01495858|B1|Baseline|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218199|NCT01495858|P3|Participant Flow|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218200|NCT01495858|P2|Participant Flow|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218307|NCT01495689|B3|Baseline|Total|Total of all reporting groups
218201|NCT01495858|P1|Participant Flow|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218202|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218203|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218204|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218205|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218206|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218207|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218208|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218209|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218210|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218211|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218212|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218213|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218214|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218215|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218216|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218217|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218218|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218219|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218220|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218221|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218222|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218223|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218224|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218225|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218226|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218227|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218228|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218229|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218230|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218231|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218232|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218233|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218234|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218235|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218236|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218237|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218238|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218239|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218240|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218241|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218242|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218243|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218244|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218245|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218246|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218247|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218248|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218249|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218250|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218251|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218252|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218253|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218254|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218255|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218256|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218257|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218258|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218259|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218260|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218261|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218262|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218263|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218264|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218265|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218266|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218267|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218268|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218269|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218270|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218271|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218272|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218273|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218274|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218275|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
218276|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
218277|NCT01495858|E3|Reported Event|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
218278|NCT01495858|E2|Reported Event|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally
218279|NCT01495858|E1|Reported Event|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally
218280|NCT01495793|B1|Baseline|Rotigotine|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
218281|NCT01495793|P1|Participant Flow|Rotigotine|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
218282|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
218283|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
218284|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
218285|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
218286|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
218287|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
218288|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
218289|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
218290|NCT01495793|E1|Reported Event|Rotigotine|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
218291|NCT01495702|B3|Baseline|Total|Total of all reporting groups
218292|NCT01495702|B2|Baseline|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
218293|NCT01495702|B1|Baseline|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
218294|NCT01495702|P2|Participant Flow|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an nonnucleoside reverse transcriptase inhibitor (NNRTI) (efavirenz (EFV), nevirapine (NVP), or rilpivirine (RPV)) plus emtricitabine (FTC)/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
218295|NCT01495702|P1|Participant Flow|Stribild|Participants switched from their baseline treatment regimen to Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) single-tablet regimen (STR) once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
218296|NCT01495702|O2|Outcome|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
218297|NCT01495702|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
218298|NCT01495702|O2|Outcome|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
218299|NCT01495702|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
218300|NCT01495702|O2|Outcome|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
218301|NCT01495702|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
218302|NCT01495702|O2|Outcome|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
218303|NCT01495702|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
218304|NCT01495702|E3|Reported Event|All Stribild|Adverse events for this reporting group include those occurring in all participants while receiving Stribild in the randomized and extension phases.
218305|NCT01495702|E2|Reported Event|NNRTI+FTC/TDF (Randomized Phase)|"Adverse events for this reporting group include those occurring in participants receiving NNRTI+FTC/TDF in the randomized phase.~Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase."
218306|NCT01495702|E1|Reported Event|Stribild (Randomized Phase)|"Adverse events for this reporting group include those occurring in participants receiving Stribild in the randomized phase.~Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase."
218308|NCT01495689|B2|Baseline|Ottawa Model With SmartCard|"On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids~Ottawa Model with SmartCard: On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids"
218309|NCT01495689|B1|Baseline|Usual Care|"Usual care for smoking cessation will be delivered to the control arm which comprises of strong physician advice, brief counseling from the clinic nurse +/- a prescription for smoking cessation aid if requested and willing~Usual care: Usual care or control arm will receive strong physician advice, brief counseling from clinic nurse +/- a prescription for smoking cessation aid if requested and willing"
218310|NCT01495689|P2|Participant Flow|Ottawa Model With SmartCard|"On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids~Ottawa Model with SmartCard: On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids"
218311|NCT01495689|P1|Participant Flow|Usual Care|"Usual care for smoking cessation will be delivered to the control arm which comprises of strong physician advice, brief counseling from the clinic nurse +/- a prescription for smoking cessation aid if requested and willing~Usual care: Usual care or control arm will receive strong physician advice, brief counseling from clinic nurse +/- a prescription for smoking cessation aid if requested and willing"
218312|NCT01495689|O2|Outcome|Ottawa Model With SmartCard|"On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids~Ottawa Model with SmartCard: On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids"
218313|NCT01495689|O1|Outcome|Usual Care|"Usual care for smoking cessation will be delivered to the control arm which comprises of strong physician advice, brief counseling from the clinic nurse +/- a prescription for smoking cessation aid if requested and willing~Usual care: Usual care or control arm will receive strong physician advice, brief counseling from clinic nurse +/- a prescription for smoking cessation aid if requested and willing"
218314|NCT01495689|E2|Reported Event|Ottawa Model With SmartCard|"On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids~Ottawa Model with SmartCard: On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids"
218315|NCT01495689|E1|Reported Event|Usual Care|"Usual care for smoking cessation will be delivered to the control arm which comprises of strong physician advice, brief counseling from the clinic nurse +/- a prescription for smoking cessation aid if requested and willing~Usual care: Usual care or control arm will receive strong physician advice, brief counseling from clinic nurse +/- a prescription for smoking cessation aid if requested and willing"
218316|NCT01495585|B4|Baseline|Total|Total of all reporting groups
218317|NCT01495585|B3|Baseline|Lonafarnib 200 mg|"4 participants were randomized to Lonafarnib 200 mg and two Placebo participants in Lonafarnib 100 mg arm received open label lonafarnib 200 mg ."
218318|NCT01495585|B2|Baseline|Lonafarnib 100 mg|6 participants were randomized to Lonafarnib 100 mg.
218319|NCT01495585|B1|Baseline|Placebo|placebo control.
218320|NCT01495585|P3|Participant Flow|Lonafarnib 200 mg|4 participants were randomized to Lonafarnib 200 mg.
218321|NCT01495585|P2|Participant Flow|Lonafarnib 100 mg|6 participants were randomized to Lonafarnib 100 mg.
218322|NCT01495585|P1|Participant Flow|Placebo|Two placebo participants in Group1 and two placebo participants in Group 2. The two placebo participants in Group 1 received open label lonafarnib 200 mg.
218323|NCT01495585|O3|Outcome|Group 2|lonafarnib 200 mg
218324|NCT01495585|O2|Outcome|Group 1|lonafarnib 100 mg
218325|NCT01495585|O1|Outcome|Placebo|"placebo control.~Group 1 placebo participants received open-label lonafarnib as group 2 participants.~Each group consisted of 8 participants (6 lonafarnib ands 2 placebo)."
218326|NCT01495585|O3|Outcome|Group 2|lonafarnib 200 mg
218327|NCT01495585|O2|Outcome|Group 1|lonafarnib 100 mg
218328|NCT01495585|O1|Outcome|Placebo|"placebo control.~Group 1 placebo participants received open-label lonafarnib as group 2 participants.~Each group consisted of 8 participants (6 lonafarnib ands 2 placebo)."
218329|NCT01495585|E3|Reported Event|Group 2|lonafarnib 200 mg
218330|NCT01495585|E2|Reported Event|Group 1|lonafarnib 100 mg
218331|NCT01495585|E1|Reported Event|Placebo|"placebo control.~Group 1 placebo participants received open-label lonafarnib as group 2 participants.~Each group consisted of 8 participants (6 lonafarnib ands 2 placebo)."
218332|NCT01495572|B3|Baseline|Total|Total of all reporting groups
218333|NCT01495572|B2|Baseline|Peripheral Blood Lymphocytes (PBL)|"Cyclophosphamide 60 mg/kg intravenous (IV ) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus MART-127-35 reactive CD8+ PBL up to 3x10^11 IV over 20-30 minutes on day 0~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days(day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
218334|NCT01495572|B1|Baseline|High Dose (HD) Aldesleukin|"Pts receiving high dose aldesleukin: Cyclophosphamide 60 mg/kg intravenous (IV) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus melanoma antigen recognized by T cells (MART)-127-35 reactive CD8+ peripheral blood lymphocytes (PBL) up to 3x1011 IV over 20-30 minutes on day 0, plus aldesleukin 720,000 IU/kg IV over 15 minutes, every 8 hrs for up to 5 days.~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~Aldesleukin: Only given to patients assigned to high dose (HD) Arm - 720,000 IU/kg IV over 15 minutes, every 8 hrs (+/- 1 hr) for up to 5 days (max 15 doses).-6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
218335|NCT01495572|P2|Participant Flow|Peripheral Blood Lymphocytes (PBL)|"Cyclophosphamide 60 mg/kg intravenous (IV ) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus MART-127-35 reactive CD8+ PBL up to 3x10^11 IV over 20-30 minutes on day 0~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
218422|NCT01494818|B2|Baseline|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
218336|NCT01495572|P1|Participant Flow|High Dose (HD) Aldesleukin|"Pts receiving high dose aldesleukin: Cyclophosphamide 60 mg/kg intravenous (IV) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus melanoma antigen recognized by T cells (MART)-127-35 reactive CD8+ peripheral blood lymphocytes (PBL) up to 3x10^11 IV over 20-30 minutes on day 0, plus aldesleukin 720,000 IU/kg IV over 15 minutes, every 8 hrs for up to 5 days.~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~Aldesleukin: Only given to patients assigned to high dose (HD) Arm - 720,000 IU/kg IV over 15 minutes, every 8 hrs (+/- 1 hr) for up to 5 days (max 15 doses).-6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
218337|NCT01495572|O2|Outcome|Peripheral Blood Lymphocytes (PBL)|"Cyclophosphamide 60 mg/kg intravenous (IV ) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus MART-127-35 reactive CD8+ PBL up to 3x1011 IV over 20-30 minutes on day 0~Fludarabine: 25 mg/m2 IV (in the vein) for 5 days(day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
218338|NCT01495572|O1|Outcome|High Dose (HD) Aldesleukin|"Pts receiving high dose aldesleukin: Cyclophosphamide 60 mg/kg intravenous (IV) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus melanoma antigen recognized by T cells (MART)-127-35 reactive CD8+ peripheral blood lymphocytes (PBL) up to 3x10^11 IV over 20-30 minutes on day 0, plus aldesleukin 720,000 IU/kg IV over 15 minutes, every 8 hrs for up to 5 days.~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~Aldesleukin: Only given to patients assigned to high dose (HD) Arm - 720,000 IU/kg IV over 15 minutes, every 8 hrs (+/- 1 hr) for up to 5 days (max 15 doses).-6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
218339|NCT01495572|O2|Outcome|Peripheral Blood Lymphocytes (PBL)|"Cyclophosphamide 60 mg/kg intravenous (IV ) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus MART-127-35 reactive CD8+ PBL up to 3x10^11 IV over 20-30 minutes on day 0~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
218340|NCT01495572|O1|Outcome|High Dose (HD) Aldesleukin|"Pts receiving high dose aldesleukin: Cyclophosphamide 60 mg/kg intravenous (IV) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus melanoma antigen recognized by T cells (MART)-127-35 reactive CD8+ peripheral blood lymphocytes (PBL) up to 3x10^11 IV over 20-30 minutes on day 0, plus aldesleukin 720,000 IU/kg IV over 15 minutes, every 8 hrs for up to 5 days.~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~Aldesleukin: Only given to patients assigned to high dose (HD) Arm - 720,000 IU/kg IV over 15 minutes, every 8 hrs (+/- 1 hr) for up to 5 days (max 15 doses).-6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
218341|NCT01495572|E2|Reported Event|Peripheral Blood Lymphocytes (PBL)|"Cyclophosphamide 60 mg/kg intravenous (IV ) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus MART-127-35 reactive CD8+ PBL up to 3x10^11 IV over 20-30 minutes on day 0~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days(day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
218342|NCT01495572|E1|Reported Event|High Dose (HD) Aldesleukin|"Pts receiving high dose aldesleukin: Cyclophosphamide 60 mg/kg intravenous (IV) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus melanoma antigen recognized by T cells (MART)-127-35 reactive CD8+ peripheral blood lymphocytes (PBL) up to 3x1011 IV over 20-30 minutes on day 0, plus aldesleukin 720,000 IU/kg IV over 15 minutes, every 8 hrs for up to 5 days.~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~Aldesleukin: Only given to patients assigned to high dose (HD) Arm - 720,000 IU/kg IV over 15 minutes, every 8 hrs (+/- 1 hr) for up to 5 days (max 15 doses).-6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
218343|NCT01495481|B1|Baseline|Adenosine and Dexmedetomidine|Patients will receive both adenosine and dexmedetomidine for the termination of SVT.
218344|NCT01495481|P1|Participant Flow|Adenosine and Dexmedetomidine|Patients will receive adenosine for termination of SVT, and then dexmedetomidine for the termination of supraventricular tachycardia (SVT) and comparison will be made for efficacy and safety.
218345|NCT01495481|O2|Outcome|Adenosine|"Patients will receive Adenosine for the termination of SVT~Adenosine: stepwise incremental approach of adenosine starting at 0.2 mg/kg (max 6 mg) followed by 0.3 mg/kg (max 12 mg) if initial dose was unsuccessful"
218346|NCT01495481|O1|Outcome|Dexmedetomidine|"Patients will receive dexmedetomidine for the termination of supraventricular tachycardia (SVT)~Dexmedetomidine: Dexmedetomidine 2 mcg/kg, Intravenous push"
218347|NCT01495481|O2|Outcome|Adenosine|"Patients will receive Adenosine for the termination of SVT~Adenosine: stepwise incremental approach of adenosine starting at 0.2 mg/kg (max 6 mg) followed by 0.3 mg/kg (max 12 mg) if initial dose was unsuccessful"
218348|NCT01495481|O1|Outcome|Dexmedetomidine|"Patients will receive dexmedetomidine for the termination of supraventricular tachycardia (SVT)~Dexmedetomidine: Dexmedetomidine 1 mcg/kg, Intravenous push"
218349|NCT01495481|O2|Outcome|Adenosine|"Patients will receive Adenosine for the termination of SVT~Adenosine: stepwise incremental approach of adenosine starting at 0.2 mg/kg (max 6 mg) followed by 0.3 mg/kg (max 12 mg) if initial dose was unsuccessful"
218350|NCT01495481|O1|Outcome|Dexmedetomidine|"Patients will receive dexmedetomidine for the termination of supraventricular tachycardia (SVT)~Dexmedetomidine: Dexmedetomidine 2 mcg/kg, Intravenous push"
218351|NCT01495481|O2|Outcome|Adenosine|"Patients will receive Adenosine for the termination of SVT~Adenosine: stepwise incremental approach of adenosine starting at 0.2 mg/kg (max 6 mg) followed by 0.3 mg/kg (max 12 mg) if initial dose was unsuccessful"
218352|NCT01495481|O1|Outcome|Dexmedetomidine|"Patients will receive dexmedetomidine for the termination of SVT~Dexmedetomidine: Dexmedetomidine 1 mcg/kg, Intravenous push"
218353|NCT01495481|E2|Reported Event|Adenosine|"Patients will receive Adenosine for the termination of SVT~Adenosine: stepwise incremental approach of adenosine starting at 0.2 mg/kg (max 6 mg) followed by 0.3 mg/kg (max 12 mg) if initial dose was unsuccessful"
218354|NCT01495481|E1|Reported Event|Dexmedetomidine|"Patients will receive dexmedetomidine for the termination of SVT~Dexmedetomidine: Dexmedetomidine 1 mcg/kg, Intravenous push"
218369|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
218355|NCT01495286|B1|Baseline|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
218356|NCT01495286|P1|Participant Flow|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
218357|NCT01495286|O1|Outcome|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
218358|NCT01495286|O1|Outcome|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
218359|NCT01495286|O1|Outcome|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
218360|NCT01495286|O1|Outcome|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
218361|NCT01495286|O1|Outcome|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
218362|NCT01495286|E1|Reported Event|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
218363|NCT01495000|B3|Baseline|Total|Total of all reporting groups
218364|NCT01495000|B2|Baseline|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
218365|NCT01495000|B1|Baseline|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
218366|NCT01495000|P2|Participant Flow|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
218367|NCT01495000|P1|Participant Flow|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
218368|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
218370|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
218371|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
218372|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
218373|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
218374|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
218375|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
218376|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
218377|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
218378|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
218379|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
218380|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
218381|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
218382|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
218383|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
218384|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
218385|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
218386|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
218387|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
218388|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
218389|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
218390|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
218391|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
218392|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
218421|NCT01494818|B3|Baseline|Total|Total of all reporting groups
218393|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
218394|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
218395|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
218396|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
218397|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
218398|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
218399|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
218400|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
218401|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
218402|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
218403|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
218404|NCT01495000|E2|Reported Event|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
218405|NCT01495000|E1|Reported Event|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
218406|NCT01494987|B3|Baseline|Total|Total of all reporting groups
218407|NCT01494987|B2|Baseline|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.~Participants were required to maintain their diet and exercise regimen."
218408|NCT01494987|B1|Baseline|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.~Participants were required to maintain their diet and exercise regimen."
218409|NCT01494987|P2|Participant Flow|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.~Participants were required to maintain their diet and exercise regimen."
218410|NCT01494987|P1|Participant Flow|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.~Participants were required to maintain their diet and exercise regimen."
218411|NCT01494987|O2|Outcome|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.~Participants were required to maintain their diet and exercise regimen."
218412|NCT01494987|O1|Outcome|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.~Participants were required to maintain their diet and exercise regimen."
218413|NCT01494987|O2|Outcome|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.~Participants were required to maintain their diet and exercise regimen."
218414|NCT01494987|O1|Outcome|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.~Participants were required to maintain their diet and exercise regimen."
218415|NCT01494987|O2|Outcome|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.~Participants were required to maintain their diet and exercise regimen."
218416|NCT01494987|O1|Outcome|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.~Participants were required to maintain their diet and exercise regimen."
218417|NCT01494987|O2|Outcome|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.~Participants were required to maintain their diet and exercise regimen."
218418|NCT01494987|O1|Outcome|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.~Participants were required to maintain their diet and exercise regimen."
218419|NCT01494987|E2|Reported Event|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.~Participants were required to maintain their diet and exercise regimen."
218420|NCT01494987|E1|Reported Event|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.~Participants were required to maintain their diet and exercise regimen."
218423|NCT01494818|B1|Baseline|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
218424|NCT01494818|P2|Participant Flow|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
218425|NCT01494818|P1|Participant Flow|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
218426|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
218427|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
218428|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
218429|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
218430|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
218431|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
218432|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
218433|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
218434|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
218435|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
218436|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
218437|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
218438|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
218439|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
218440|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
218441|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
218442|NCT01494818|E2|Reported Event|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
218443|NCT01494818|E1|Reported Event|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
218444|NCT01494753|B3|Baseline|Total|Total of all reporting groups
218445|NCT01494753|B2|Baseline|T2345/Prostaglandin|One drop at 8.00pm.
218446|NCT01494753|B1|Baseline|Prostaglandin/T2345|One drop at 8.00pm.
218447|NCT01494753|P2|Participant Flow|T2345/Prostaglandin|One drop at 8.00pm.
218448|NCT01494753|P1|Participant Flow|Prostaglandin/T2345|One drop at 8.00pm.
218449|NCT01494753|O2|Outcome|T2345/Prostaglandin|One drop at 8.00pm.
218450|NCT01494753|O1|Outcome|Prostaglandin/T2345|One drop at 8.00pm.
218451|NCT01494753|E2|Reported Event|T2345|One drop at 8.00pm.
218452|NCT01494753|E1|Reported Event|Prostaglandin|One drop at 8.00pm.
218453|NCT01494649|B3|Baseline|Total|Total of all reporting groups
218454|NCT01494649|B2|Baseline|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
218455|NCT01494649|B1|Baseline|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily.
218456|NCT01494649|P2|Participant Flow|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
218457|NCT01494649|P1|Participant Flow|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily.
218458|NCT01494649|O2|Outcome|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
218459|NCT01494649|O1|Outcome|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
218460|NCT01494649|O2|Outcome|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
218461|NCT01494649|O1|Outcome|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
218462|NCT01494649|O2|Outcome|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
218463|NCT01494649|O1|Outcome|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
218464|NCT01494649|O2|Outcome|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
218465|NCT01494649|O1|Outcome|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeths for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
218466|NCT01494649|O2|Outcome|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
218467|NCT01494649|O1|Outcome|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
218468|NCT01494649|O2|Outcome|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily.
218469|NCT01494649|O1|Outcome|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
218470|NCT01494649|E2|Reported Event|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
218471|NCT01494649|E1|Reported Event|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute, for 14 days twice daily. The test product is a commercially available product.
218472|NCT01494610|B1|Baseline|FP/Salmeterol 250/50 mcg|Participants received fluticasone propionate (FP)/salmeterol 250/50 micrograms (mcg) twice daily via a capsule-based inhaler for two 10-day periods and via a multi-dose dry powder (MDPI) inhaler for two 10-day periods in a replicate crossover design. Participants were dosed approximately every 12 hours. Treatment was given in one of two sequences in Periods 1, 2, 3, and 4 (with no washouts between periods), respectively: ABBA, BAAB. A, FP/salmeterol from an MDPI; B, FP/salmeterol from a capsule-based inhaler.
218473|NCT01494610|P2|Participant Flow|FP/Salmeterol 250/50 mcg: Sequence BAAB|Participants received fluticasone propionate (FP)/salmeterol 250/50 micrograms (mcg) twice daily via a capsule-based inhaler for two 10-day periods and via a multi-dose dry powder (MDPI) inhaler for two 10-day periods in a replicate crossover design. Participants were dosed approximately every 12 hours. Treatment was given in the sequence of BAAB in Periods 1, 2, 3, and 4 (with no washouts between periods), respectively. A, FP/salmeterol from an MDPI; B, FP/salmeterol from a capsule-based inhaler.
218474|NCT01494610|P1|Participant Flow|FP/Salmeterol 250/50 mcg: Sequence ABBA|Participants received fluticasone propionate (FP)/salmeterol 250/50 micrograms (mcg) twice daily via a capsule-based inhaler for two 10-day periods and via a multi-dose dry powder (MDPI) inhaler for two 10-day periods in a replicate crossover design. Participants were dosed approximately every 12 hours. Treatment was given in the sequence of ABBA in Periods 1, 2, 3, and 4 (with no washouts between periods), respectively. A, FP/salmeterol from an MDPI; B, FP/salmeterol from a capsule-based inhaler.
218475|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218476|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218477|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218478|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218479|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218480|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218481|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218482|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218483|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218484|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218485|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218486|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218876|NCT01494467|O1|Outcome|CD5024 1% Cream|CD5024 1% Cream, once daily application for 12 weeks
218487|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218488|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218489|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218490|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218491|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218492|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218493|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218494|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218495|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218496|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218497|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218498|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218499|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218500|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218501|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218502|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218503|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218504|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218505|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218506|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218507|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218508|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218509|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218510|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218511|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218512|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218513|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218514|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218877|NCT01494467|O2|Outcome|CD5024 Vehicle Cream|CD5024 Vehicle Cream, once daily application for 12 weeks
218515|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218516|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218517|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218518|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218519|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218520|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218521|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218522|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218523|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218524|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218525|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218526|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218527|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218528|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218529|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218530|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218531|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
218532|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
218533|NCT01494610|E8|Reported Event|FP/Salmeterol From Capsule-based Inhaler 2nd Admin, COPD|Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
218534|NCT01494610|E7|Reported Event|FP/Salmeterol From Capsule-based Inhaler 1st Admin, COPD|Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
218535|NCT01494610|E6|Reported Event|FP/Salmeterol From MDPI 2nd Admin, COPD|Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
218536|NCT01494610|E5|Reported Event|FP/Salmeterol From MDPI 1st Admin, COPD|Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
218537|NCT01494610|E4|Reported Event|FP/Salmeterol From Capsule-based Inhaler 2nd Admin, Asthma|Fluticasone propionate (FP)/salmeterol combination was administered to participants with asthma as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
218538|NCT01494610|E3|Reported Event|FP/Salmeterol From Capsule-based Inhaler 1st Admin, Asthma|Fluticasone propionate (FP)/salmeterol combination was administered to participants with asthma as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
218539|NCT01494610|E2|Reported Event|FP/Salmeterol From MDPI 2nd Admin, Asthma|Fluticasone propionate (FP)/salmeterol combination was administered to particiapants with asthma as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
218540|NCT01494610|E1|Reported Event|FP/Salmeterol From MDPI 1st Administration (Admin), Asthma|Fluticasone propionate (FP)/salmeterol combination was administered to participants with asthma as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
218656|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
221040|NCT01487161|O2|Outcome|FX006 40 mg|FX006: Single 3 mL IA injection
218541|NCT01494584|B1|Baseline|Ezogabine/Retigabine|Participants received an initial dose of ezogabine/retigabine 300 milligrams (mg) per day administered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at Weeks 1, 3, and 5. Dose titration occurred no more than once per week, with participants receiving up-titrated daily doses of 450 mg (150 mg TID), 600 mg (200 mg TID), 750 mg (250 mg TID), and 900 mg (300 mg TID) at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218542|NCT01494584|P1|Participant Flow|Ezogabine/Retigabine|Participants recieved an initial dose of ezogabine/retigabine 300 milligrams (mg) per day administered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at Weeks 1, 3, and 5. Dose titration occurred no more than once per week, with participants receiving up-titrated daily doses of 450 mg (150 mg TID), 600 mg (200 mg TID), 750 mg (250 mg TID), and 900 mg (300 mg TID) at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218543|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218544|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218545|NCT01494584|O5|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg, 600 mg, and 750 mg (as 150 mg IR, 200 mg IR, and 250 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 900 mg/day ezogabine/retigabine as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218546|NCT01494584|O4|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218547|NCT01494584|O3|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218548|NCT01494584|O2|Outcome|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an up-titrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218549|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administerd as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218550|NCT01494584|O5|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg, 600 mg, and 750 mg (as 150 mg IR, 200 mg IR, and 250 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 900 mg/day ezogabine/retigabine as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218551|NCT01494584|O4|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218552|NCT01494584|O3|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218657|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
221041|NCT01487161|O1|Outcome|FX006 10 mg|FX006: Single 3 mL IA injection
218553|NCT01494584|O2|Outcome|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an up-titrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218554|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administerd as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218555|NCT01494584|O5|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg, 600 mg, and 750 mg (as 150 mg IR, 200 mg IR, and 250 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 900 mg/day ezogabine/retigabine as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218556|NCT01494584|O4|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218557|NCT01494584|O3|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218558|NCT01494584|O2|Outcome|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an up-titrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218559|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administerd as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218560|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218561|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218562|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218563|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218564|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218565|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R)300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218878|NCT01494467|O1|Outcome|CD5024 1% Cream|CD5024 1% Cream, once daily application for 12 weeks
218566|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218567|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218568|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly upitration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218569|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218570|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218571|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218572|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants recieved an initial dose of ezogabine/retigabine 300 mg/day administered as 100 mg IR tablets TID orally and underwent weekly up-titration at Weeks 1, 3, and 5. Dose titration occurred no more than once per week, with participants receiving up-titrated daily doses of 450 mg (150 mg TID), 600 mg (200 mg TID), 750 mg (250 mg TID), and 900 mg (300 mg TID) at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218573|NCT01494584|O5|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg, 600 mg, and 750 mg (as 150 mg IR, 200 mg IR, and 250 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 900 mg/day ezogabine/retigabine as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218574|NCT01494584|O4|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of>50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218575|NCT01494584|O3|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218576|NCT01494584|O2|Outcome|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an up-titrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218577|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administerd as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218658|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218659|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218879|NCT01494467|O2|Outcome|CD5024 Vehicle Cream|CD5024 Vehicle Cream, once daily application for 12 weeks
218578|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218579|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218580|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218581|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218582|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218583|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218584|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218585|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218586|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218587|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218588|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218589|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218660|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218880|NCT01494467|O1|Outcome|CD5024 1% Cream|CD5024 1% Cream, once daily application for 12 weeks
218590|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218591|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218592|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218593|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218594|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218595|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218596|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218597|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218598|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218599|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218600|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218601|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218661|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218881|NCT01494467|E8|Reported Event|CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Overall|Overall number of subjects with adverse events for the entire duration of study
218602|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218603|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218604|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218605|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218606|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218607|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218608|NCT01494584|O5|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg, 600 mg, and 750 mg (as 150 mg IR, 200 mg IR, and 250 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 900 mg/day ezogabine/retigabine as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218609|NCT01494584|O4|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218610|NCT01494584|O3|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218611|NCT01494584|O2|Outcome|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an uptitrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218612|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administerd as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218613|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218662|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
221466|NCT01484834|B5|Baseline|Total|Total of all reporting groups
218614|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218615|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218616|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218617|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218618|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218619|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218620|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218621|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218622|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218623|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218624|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants (par.) with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218625|NCT01494584|E5|Reported Event|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg, 600 mg, and 750 mg (as 150 mg IR, 200 mg IR, and 250 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 900 mg/day ezogabine/retigabine as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218663|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218664|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218626|NCT01494584|E4|Reported Event|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218627|NCT01494584|E3|Reported Event|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218628|NCT01494584|E2|Reported Event|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an up-titrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218629|NCT01494584|E1|Reported Event|Regimen A: Ezogabine/Retigabine 300 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administerd as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
218630|NCT01494545|B1|Baseline|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218631|NCT01494545|P1|Participant Flow|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218632|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218633|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218634|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218635|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218636|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218637|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218638|NCT01494545|O3|Outcome|Delefilcon A, Both Eyes|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218639|NCT01494545|O2|Outcome|Delefilcon A, Left Eye|Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
218640|NCT01494545|O1|Outcome|Delefilcon A, Right Eye|Delefilcon A contact lenses worn in right eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
218641|NCT01494545|O3|Outcome|Delefilcon A, Both Eyes|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218642|NCT01494545|O2|Outcome|Delefilcon A, Left Eye|Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
218643|NCT01494545|O1|Outcome|Delefilcon A, Right Eye|Delefilcon A contact lenses worn in right eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
218644|NCT01494545|O3|Outcome|Delefilcon A, Both Eyes|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218645|NCT01494545|O2|Outcome|Delefilcon A, Left Eye|Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
218646|NCT01494545|O1|Outcome|Delefilcon A, Right Eye|Delefilcon A contact lenses worn in right eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
218647|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218648|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218649|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218650|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218651|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218652|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218653|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218654|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218655|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
222621|NCT01480232|B5|Baseline|Total|Total of all reporting groups
218665|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218666|NCT01494545|E1|Reported Event|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
218667|NCT01494532|B7|Baseline|Total|Total of all reporting groups
218668|NCT01494532|B6|Baseline|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218669|NCT01494532|B5|Baseline|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218670|NCT01494532|B4|Baseline|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218671|NCT01494532|B3|Baseline|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218672|NCT01494532|B2|Baseline|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218673|NCT01494532|B1|Baseline|Treatment Group A: Placebo|Participants (par.) were administered a matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218674|NCT01494532|P6|Participant Flow|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218675|NCT01494532|P5|Participant Flow|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218676|NCT01494532|P4|Participant Flow|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218677|NCT01494532|P3|Participant Flow|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218678|NCT01494532|P2|Participant Flow|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218679|NCT01494532|P1|Participant Flow|Treatment Group A: Placebo|Participants (par.) were administered a matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218680|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
222820|NCT01479764|B3|Baseline|Total|Total of all reporting groups
218681|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218682|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218683|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218684|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218685|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218686|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218687|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218688|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218689|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218690|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218691|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218692|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218693|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218694|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218695|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218696|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218697|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218698|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218699|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218700|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218701|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218702|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218703|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218704|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218705|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218706|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218707|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218708|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218887|NCT01494467|E2|Reported Event|CD5024 Vehicle Cream - Part A|Part A: CD5024 Vehicle Cream, once daily application for 12 weeks
218709|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218710|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218711|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218712|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218713|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218714|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218715|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218716|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218717|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218718|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218719|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218720|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218721|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218722|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218882|NCT01494467|E7|Reported Event|CD5024 1% Cream - Overall|Overall number of subjects with adverse events for the entire duration of study
226481|NCT01468675|O2|Outcome|Control|Usual care
218723|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218724|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218725|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218726|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218727|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218728|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218729|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218730|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218731|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218732|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218733|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218734|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218735|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218736|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218737|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218738|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218739|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218740|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218741|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218742|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218743|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218744|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218745|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218746|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218747|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218748|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218749|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218750|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218883|NCT01494467|E6|Reported Event|CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Part C|Part C: 4 week safety follow up. No drug applications
218751|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218752|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218753|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218754|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218755|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218756|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218757|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218758|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218759|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218760|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218761|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218762|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218763|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218764|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218884|NCT01494467|E5|Reported Event|CD5024 1% Cream - Part C|Part C: 4 week safety follow up. No drug applications
220853|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
218765|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218766|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218767|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218768|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218769|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218770|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218771|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218772|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218773|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218774|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218775|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218776|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218777|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218778|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218779|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218780|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218781|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218782|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218783|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218784|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218785|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218786|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218787|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218788|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218789|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218790|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218791|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218792|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218888|NCT01494467|E1|Reported Event|CD5024 1% Cream - Part A|Part A: CD5024 1% Cream, once daily application for 12 weeks
218793|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218794|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218795|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218796|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218797|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218798|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218799|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218800|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218801|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218802|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218803|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218804|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218805|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218806|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218885|NCT01494467|E4|Reported Event|Azelaic Acid 15% Gel - Part B|Part B: Subjects in the CD5024 Vehicle Cream arm applied Azelaic Acid 15% Gel twice daily for 40 weeks
218807|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218808|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218809|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218810|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218811|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218812|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218813|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218814|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218815|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218816|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218817|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218818|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218819|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218820|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218821|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218822|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218823|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218824|NCT01494532|E6|Reported Event|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218825|NCT01494532|E5|Reported Event|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218826|NCT01494532|E4|Reported Event|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218827|NCT01494532|E3|Reported Event|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218828|NCT01494532|E2|Reported Event|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
218829|NCT01494532|E1|Reported Event|Treatment Group A: Placebo|Participants (par.) were administered a matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
218830|NCT01494506|B4|Baseline|Total|Total of all reporting groups
218831|NCT01494506|B3|Baseline|MM-398, 5-FU and Leucovorin|"MM-398, 5-FU and Leucovorin Q2W IV~MM-398: Arm A: MM-398 120 mg/m2 IV Q3W~Arm C: MM-398 80mg/m2 IV Q2W~5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks~Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: Leucovorin 400 mg/m2 IV every 2 weeks"
218832|NCT01494506|B2|Baseline|5 Fluorouracil and Leucovorin IV|"5 Fluorouracil and Leucovorin IV~5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks~Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: Leucovorin 400 mg/m2 IV every 2 weeks"
218833|NCT01494506|B1|Baseline|MM-398|"MM-398 Q3W IV~MM-398: Arm A: MM-398 120 mg/m2 IV Q3W~Arm C: MM-398 80mg/m2 IV Q2W"
218834|NCT01494506|P3|Participant Flow|MM-398 + 5-FU + Leucovorin (Arm C)|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
218835|NCT01494506|P2|Participant Flow|5-FU + Leucovorin (Arm B)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
218836|NCT01494506|P1|Participant Flow|MM-398 (Arm A)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
218853|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
218886|NCT01494467|E3|Reported Event|CD5024 1% Cream - Part B|Part B CD5024 1% Cream, once daily application for 40 weeks
218837|NCT01494506|O2|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
218838|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
218839|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
218840|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
218841|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
218842|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
218843|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
218844|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
218845|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
218846|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
218847|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
218848|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
218849|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
218850|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
218851|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
218852|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
218874|NCT01494467|P1|Participant Flow|CD5024 1% Cream|Part A & B: CD5024 1% Cream, once daily application
218875|NCT01494467|O2|Outcome|CD5024 Vehicle Cream|CD5024 Vehicle Cream, once daily application for 12 weeks
218854|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
218855|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
218856|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
218857|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
218858|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
218859|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
218860|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
218861|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
218862|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
218863|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
218864|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
218865|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
218866|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
218867|NCT01494506|E3|Reported Event|MM-398, 5-FU and Leucovorin|"MM-398, 5-FU and Leucovorin Q2W IV~MM-398: Arm A: MM-398 120 mg/m2 IV Q3W~Arm C: MM-398 80mg/m2 IV Q2W~5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks~Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: Leucovorin 400 mg/m2 IV every 2 weeks"
218868|NCT01494506|E2|Reported Event|5 Fluorouracil and Leucovorin IV|"5 Fluorouracil and Leucovorin IV~5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks~Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: Leucovorin 400 mg/m2 IV every 2 weeks"
218869|NCT01494506|E1|Reported Event|MM-398|"MM-398 Q3W IV~MM-398: Arm A: MM-398 120 mg/m2 IV Q3W~Arm C: MM-398 80mg/m2 IV Q2W"
218870|NCT01494467|B3|Baseline|Total|Total of all reporting groups
218871|NCT01494467|B2|Baseline|CD5024 Vehicle Cream/Azelaic Acid 15% Gel|"Part A: CD5024 Vehicle Cream, once daily application for 12 weeks~Part B: Azelaic acid 15% Gel, twice daily application for 40 weeks"
218872|NCT01494467|B1|Baseline|CD5024 1% Cream|"Part A: CD5024 1% Cream, once daily application for 12 weeks~Part B: CD5024 1% Cream, once daily application for 40 weeks"
218873|NCT01494467|P2|Participant Flow|CD5024 Vehicle Cream/Azelaic Acid 15% Gel|"Part A: CD5024 Vehicle Cream, once daily application~Part B: Azelaic acid 15% Gel, twice daily application"
229010|NCT01461369|O3|Outcome|Placebo|Placebo: Capsule
218889|NCT01494350|B1|Baseline|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
218890|NCT01494350|P1|Participant Flow|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
218891|NCT01494350|O1|Outcome|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
218892|NCT01494350|O1|Outcome|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
218893|NCT01494350|O1|Outcome|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
218894|NCT01494350|O1|Outcome|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
218895|NCT01494350|O1|Outcome|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
218896|NCT01494350|E1|Reported Event|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
218897|NCT01494298|B3|Baseline|Total|Total of all reporting groups
218898|NCT01494298|B2|Baseline|Controls|African American Men without diabetes
218899|NCT01494298|B1|Baseline|T2DM|African American Men with Type 2 Diabetes
218900|NCT01494298|P2|Participant Flow|Controls|African American men without type 2 diabetes and not taking cholesterol-lowering medications.
218901|NCT01494298|P1|Participant Flow|T2DM|African American men with type 2 diabetes and not taking cholesterol-lowering medications.
218902|NCT01494298|O2|Outcome|Controls|
218903|NCT01494298|O1|Outcome|T2DM|
218904|NCT01494298|O2|Outcome|Controls|African-American men without type 2 diabetes who are not taking cholesterol lowering medications
218905|NCT01494298|O1|Outcome|T2DM|African-American men with type 2 diabetes who are not taking cholesterol lowering medications
218906|NCT01494298|O2|Outcome|Controls|
218907|NCT01494298|O1|Outcome|T2DM|
218908|NCT01494298|E2|Reported Event|Controls|African American men without type 2 diabetes and not taking cholesterol-lowering medications.
218909|NCT01494298|E1|Reported Event|T2DM|African American men with type 2 diabetes and not taking cholesterol-lowering medications.
218910|NCT01493960|B3|Baseline|Total|Total of all reporting groups
218911|NCT01493960|B2|Baseline|Placebo|"2 doses 4 weeks apart~Placebo: Rectal dose at week 0 and 4"
218912|NCT01493960|B1|Baseline|Cobitolimod|"2 doses 4 weeks apart~Cobitolimod: 30 mg rectal dose at week 0 and 4"
218913|NCT01493960|P2|Participant Flow|Placebo|"2 doses 4 weeks apart~Placebo: Rectal dose at week 0 and 4"
218914|NCT01493960|P1|Participant Flow|Cobitolimod|"2 doses 4 weeks apart~Cobitolimod: 30 mg rectal dose at week 0 and 4"
218915|NCT01493960|O2|Outcome|Placebo|"2 doses 4 weeks apart~Placebo: Rectal dose at week 0 and 4"
218916|NCT01493960|O1|Outcome|Cobitolimod|"2 doses 4 weeks apart~Cobitolimod: 30 mg rectal dose at week 0 and 4"
218917|NCT01493960|O2|Outcome|Placebo|"2 doses 4 weeks apart~Placebo: Rectal dose at week 0 and 4"
218918|NCT01493960|O1|Outcome|Cobitolimod|"2 doses 4 weeks apart~Cobitolimod: 30 mg rectal dose at week 0 and 4"
218919|NCT01493960|O2|Outcome|Placebo|"2 doses 4 weeks apart~Placebo: Rectal dose at week 0 and 4"
218920|NCT01493960|O1|Outcome|Cobitolimod|"2 doses 4 weeks apart~Cobitolimod: 30 mg rectal dose at week 0 and 4"
218921|NCT01493960|O2|Outcome|Placebo|"2 doses 4 weeks apart~Placebo: Rectal dose at week 0 and 4"
218922|NCT01493960|O1|Outcome|Cobitolimod|"2 doses 4 weeks apart~Cobitolimod: 30 mg rectal dose at week 0 and 4"
218923|NCT01493960|O2|Outcome|Placebo|"2 doses 4 weeks apart~Placebo: Rectal dose at week 0 and 4"
218924|NCT01493960|O1|Outcome|Cobitolimod|"2 doses 4 weeks apart~Cobitolimod: 30 mg rectal dose at week 0 and 4"
218925|NCT01493960|O2|Outcome|Placebo|"2 doses 4 weeks apart~Placebo: Rectal dose at week 0 and 4"
218926|NCT01493960|O1|Outcome|Cobitolimod|"2 doses 4 weeks apart~Cobitolimod: 30 mg rectal dose at week 0 and 4"
218927|NCT01493960|O2|Outcome|Placebo|"2 doses 4 weeks apart~Placebo: Rectal dose at week 0 and 4"
218928|NCT01493960|O1|Outcome|Cobitolimod|"2 doses 4 weeks apart~Cobitolimod: 30 mg rectal dose at week 0 and 4"
218929|NCT01493960|E2|Reported Event|Placebo|"2 doses 4 weeks apart~Placebo: Rectal dose at week 0 and 4"
218930|NCT01493960|E1|Reported Event|Cobitolimod|"2 doses 4 weeks apart~Cobitolimod: 30 mg rectal dose at week 0 and 4"
218931|NCT01493947|B3|Baseline|Total|Total of all reporting groups
218932|NCT01493947|B2|Baseline|Metronidazole 0.75% Cream|Metronidazole 0.75% cream: Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
218933|NCT01493947|B1|Baseline|Ivermectin|Ivermectin: Ivermectin applied once daily on the face during 16-week plus 36-week extension period.
218934|NCT01493947|P2|Participant Flow|Metronidazole 0.75% Cream|Metronidazole 0.75% cream applied twice daily on the face during 16-week
218935|NCT01493947|P1|Participant Flow|Ivermectin|Ivermectin applied once daily on the face during 16-week
218936|NCT01493947|O2|Outcome|Metronidazole 0.75% Cream|Metronidazole 0.75% cream: Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
218937|NCT01493947|O1|Outcome|CD5024|CD5024: CD5024 applied once daily on the face during 16-week plus 36-week extension period.
218938|NCT01493947|O2|Outcome|Metronidazole 0.75% Cream|Metronidazole 0.75% cream: Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
218939|NCT01493947|O1|Outcome|Ivermectin|Ivermectin: Ivermectin applied once daily on the face during 16-week plus 36-week extension period.
218940|NCT01493947|E4|Reported Event|Metronidazole 0.75% Cream Period B|36-week extension period : only subjects with an IGA of 0 or 1 at Week 16 (i.e., at the last visit of Period A) were eligible.
218941|NCT01493947|E3|Reported Event|Ivermectin 1% Cream Period B|36-week extension period :only subjects with an IGA of 0 or 1 at Week 16 (i.e., at the last visit of Period A) were eligible
218942|NCT01493947|E2|Reported Event|Metronidazole 0.75% Cream Period A|Metronidazole 0.75% cream applied twice daily on the face during 16-week
218943|NCT01493947|E1|Reported Event|Ivermectin 1% Cream Period A|Ivermectin applied once daily on the face during 16-week
218944|NCT01493687|B3|Baseline|Total|Total of all reporting groups
218945|NCT01493687|B2|Baseline|CD5024 Vehicle Cream/Azelaic Acid 15% Gel|"Part A: CD5024 Vehicle Cream, once daily application for 12 weeks~Part B: Azelaic acid 15% Gel, twice daily application for 40 weeks"
218946|NCT01493687|B1|Baseline|CD5024 1% Cream|Part A: CD5024 1% Cream, once daily application for 12 weeks Part B: CD5024 1% Cream, once daily application for 40 weeks
218947|NCT01493687|P2|Participant Flow|CD5024 Vehicle Cream/Azelaic Acid 15% Gel|"Part A: CD5024 Vehicle Cream, once daily application~Part B: Azelaic acid 15% Gel, twice daily application"
218948|NCT01493687|P1|Participant Flow|CD5024 1% Cream|Part A & B: CD5024 1% Cream, once daily application
218949|NCT01493687|O2|Outcome|CD5024 Vehicle Cream|CD5024 Vehicle Cream, once daily application for 12 weeks
218950|NCT01493687|O1|Outcome|CD5024 1% Cream|CD5024: CD5024 1% Cream, once daily application for 12 weeks
218951|NCT01493687|O2|Outcome|CD5024 Vehicle Cream|CD5024 Vehicle Cream, once daily application for 12 weeks
218952|NCT01493687|O1|Outcome|CD5024 1% Cream|CD5024: CD5024 1% Cream, once daily application for 12 weeks
218953|NCT01493687|O2|Outcome|CD5024 Vehicle Cream|CD5024 Vehicle Cream, once daily application for 12 weeks
218954|NCT01493687|O1|Outcome|CD5024 1% Cream|CD5024: CD5024 1% Cream, once daily application for 12 weeks
218955|NCT01493687|E8|Reported Event|CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Overall|Overall number of subjects with adverse events for the entire duration of study
218956|NCT01493687|E7|Reported Event|CD5024 1% Cream - Overall|Overall number of subjects with adverse events for the entire duration of study
218957|NCT01493687|E6|Reported Event|CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Part C|Part C: 4 week safety follow up. No drug applications
218958|NCT01493687|E5|Reported Event|CD5024 1% Cream - Part C|Part C: 4 week safety follow up. No drug applications
218959|NCT01493687|E4|Reported Event|Azelaic Acid 15% Gel - Part B|Part B: Subjects in the CD5024 Vehicle Cream arm applied Azelaic Acid 15% Gel twice daily for 40 weeks
218960|NCT01493687|E3|Reported Event|CD5024 1% Cream - Part B|Part B CD5024 1% Cream, once daily application for 40 weeks
218961|NCT01493687|E2|Reported Event|CD5024 Vehicle Cream - Part A|Part A: CD5024 Vehicle Cream, once daily application for 12 weeks
218962|NCT01493687|E1|Reported Event|CD5024 1% Cream - Part A|Part A: CD5024 1% Cream, once daily application for 12 weeks
218963|NCT01493557|B4|Baseline|Total|Total of all reporting groups
218964|NCT01493557|B3|Baseline|Pradaxa, Never Randomized|Patients who were treated for 3 months with Pradaxa ® and were never randomized to management strategies.
218965|NCT01493557|B2|Baseline|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
218966|NCT01493557|B1|Baseline|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
218967|NCT01493557|P3|Participant Flow|Pradaxa, Never Randomized|Patients who were treated for 3 months with Pradaxa ® and were never randomized to management strategies.
218968|NCT01493557|P2|Participant Flow|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
218969|NCT01493557|P1|Participant Flow|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
218970|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
218971|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
218972|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
218973|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
218974|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
218975|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
218976|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
219804|NCT01490632|O1|Outcome|Part B: Responder - Low Dose|Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
218977|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
218978|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
218979|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
218980|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
218981|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
218982|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
218983|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
218984|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
218985|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
218986|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
218987|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
218988|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
218989|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
218990|NCT01493557|E3|Reported Event|Pradaxa, Never Randomized|Patients who were treated for 3 months with Pradaxa ® and were never randomized to management strategies.
218991|NCT01493557|E2|Reported Event|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
218992|NCT01493557|E1|Reported Event|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
218993|NCT01493531|B4|Baseline|Total|Total of all reporting groups
218994|NCT01493531|B3|Baseline|Placebo + Allopurinol|
218995|NCT01493531|B2|Baseline|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
218996|NCT01493531|B1|Baseline|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
218997|NCT01493531|P3|Participant Flow|Placebo + Allopurinol|
218998|NCT01493531|P2|Participant Flow|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
218999|NCT01493531|P1|Participant Flow|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
219000|NCT01493531|O3|Outcome|Placebo + Allopurinol|placebo qd plus allopurinol
219001|NCT01493531|O2|Outcome|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
219002|NCT01493531|O1|Outcome|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
219003|NCT01493531|O3|Outcome|Placebo + Allopurinol|placebo qd plus allopurinol
219004|NCT01493531|O2|Outcome|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
219005|NCT01493531|O1|Outcome|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
219006|NCT01493531|O3|Outcome|Placebo + Allopurinol|placebo qd plus allopurinol
219007|NCT01493531|O2|Outcome|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
219008|NCT01493531|O1|Outcome|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
219009|NCT01493531|E3|Reported Event|Placebo + Allopurinol|
219010|NCT01493531|E2|Reported Event|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
219011|NCT01493531|E1|Reported Event|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
219012|NCT01493427|B1|Baseline|TRAVATAN® BAK-free|"Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks~Travoprost 0.004%: Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative"
219013|NCT01493427|P1|Participant Flow|TRAVATAN® BAK-free|"Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks~Travoprost 0.004%: Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative"
219014|NCT01493427|O1|Outcome|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks
219015|NCT01493427|O1|Outcome|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks
219016|NCT01493427|E1|Reported Event|TRAVATAN® BAK-free|"Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks~Travoprost 0.004%: Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative"
219017|NCT01493284|B1|Baseline|Transfemoral|Transfemoral access
219018|NCT01493284|P1|Participant Flow|Transfemoral|Transfemoral access
219019|NCT01493284|O1|Outcome|Transfemoral|Transfemoral access
219020|NCT01493284|O1|Outcome|Transfemoral|Transfemoral access
219021|NCT01493284|O1|Outcome|Transfemoral|Transfemoral access
219022|NCT01493284|O1|Outcome|Transfemoral|Transfemoral access
219023|NCT01493284|E1|Reported Event|Transfemoral|Transfemoral access
219024|NCT01493180|B3|Baseline|Total|Total of all reporting groups
219025|NCT01493180|B2|Baseline|Sodium Hyaluronate Ophthalmic Solution|Sodium hyaluronate ophthalmic solution 0.1%
219026|NCT01493180|B1|Baseline|OPC-12759 Ophthalmic Suspension|OPC-12759 ophthalmic suspension 2%
219027|NCT01493180|P2|Participant Flow|Sodium Hyaluronate Ophthalmic Solution|Sodium hyaluronate ophthalmic solution 0.1%
219028|NCT01493180|P1|Participant Flow|OPC-12759 Ophthalmic Suspension|OPC-12759 ophthalmic suspension 2%
219029|NCT01493180|O2|Outcome|Sodium Hyaluronate Ophthalmic Solution|Sodium hyaluronate ophthalmic solution 0.1%
219030|NCT01493180|O1|Outcome|OPC-12759 Ophthalmic Suspension|OPC-12759 ophthalmic suspension 2%
219031|NCT01493180|E2|Reported Event|Sodium Hyaluronate Ophthalmic Solution|Sodium hyaluronate ophthalmic solution 0.1%
219032|NCT01493180|E1|Reported Event|OPC-12759 Ophthalmic Suspension|OPC-12759 ophthalmic suspension 2%
219033|NCT01493167|B1|Baseline|Woodcast Circular System Casts|Operatively treated adult patients needing a post-operative Circular Woodcast scaphoid-type cast
219034|NCT01493167|P1|Participant Flow|Limb Casting/Splinting|"Patient age 0-90 years. Patient treatment requires extremity immobilization~limb casting/splinting: ankle and arm cast"
219035|NCT01493167|O1|Outcome|Limb Casting/Splinting|"Patient age 0-90 years. Patient treatment requires extremity immobilization~limb casting/splinting: ankle and arm cast"
219036|NCT01493167|E1|Reported Event|Limb Casting/Splinting|"Patient age 0-90 years. Patient treatment requires extremity immobilization~limb casting/splinting: ankle and arm cast"
219037|NCT01493089|B3|Baseline|Total|Total of all reporting groups
219038|NCT01493089|B2|Baseline|Losec|Treatment of heartburn with Losec
219039|NCT01493089|B1|Baseline|Zegerid|Treatment of heartburn with Zegerid
219040|NCT01493089|P2|Participant Flow|Losec|Treatment of heartburn with 20mg Losec over-capsulated capsule plus placebo suspension once a day
219041|NCT01493089|P1|Participant Flow|Zegerid|Treatment of heartburn with 20mg Zegerid suspension plus over-encapsulated placebo capsule once a day
219042|NCT01493089|O2|Outcome|Losec Group|
219043|NCT01493089|O1|Outcome|Zegerid Group|
219044|NCT01493089|O2|Outcome|Losec Group|
219045|NCT01493089|O1|Outcome|Zegerid Group|
219046|NCT01493089|O2|Outcome|Losec Group|
219047|NCT01493089|O1|Outcome|Zegerid Group|
219048|NCT01493089|O2|Outcome|Losec Group|
219049|NCT01493089|O1|Outcome|Zegerid Group|
219050|NCT01493089|O2|Outcome|Losec Group|
219051|NCT01493089|O1|Outcome|Zegerid Group|
219052|NCT01493089|O2|Outcome|Losec Group|20mg Losec over-encapsulated capsule plus placebo suspension
219053|NCT01493089|O1|Outcome|Zegerid Group|20mg Zegerid suspension plus over-encapsulated placebo capsule
219054|NCT01493089|E2|Reported Event|Losec|Treatment of heartburn with Losec
219055|NCT01493089|E1|Reported Event|Zegerid|Treatment of heartburn with Zegerid
219056|NCT01492439|B3|Baseline|Total|Total of all reporting groups
219057|NCT01492439|B2|Baseline|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
219058|NCT01492439|B1|Baseline|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
219059|NCT01492439|P2|Participant Flow|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
219060|NCT01492439|P1|Participant Flow|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a week for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
219061|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
219062|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
219597|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
219063|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
219064|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
219065|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
219066|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
219067|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
219068|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
219069|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
219070|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
219071|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
219072|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
219073|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
219074|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
219075|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
219076|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
219077|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
219078|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
219079|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
219080|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
219081|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
219082|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
219083|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
219084|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
219085|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
219086|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
219087|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
219088|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
219089|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
219090|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
219091|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
219092|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
219093|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
219094|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
219095|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
219096|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
219097|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
219098|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
219099|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
219401|NCT01491607|O4|Outcome|BioThrax 1st Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
220854|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
219100|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
219101|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
219102|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
219103|NCT01492439|E2|Reported Event|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
219104|NCT01492439|E1|Reported Event|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
219105|NCT01492426|B3|Baseline|Total|Total of all reporting groups
219106|NCT01492426|B2|Baseline|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
219107|NCT01492426|B1|Baseline|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
219108|NCT01492426|P2|Participant Flow|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
219109|NCT01492426|P1|Participant Flow|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
219110|NCT01492426|O2|Outcome|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food.
219111|NCT01492426|O1|Outcome|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
219112|NCT01492426|O2|Outcome|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
219113|NCT01492426|O1|Outcome|Daclatasvir + PEG-IFN Alpha-2a+ Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
219114|NCT01492426|O2|Outcome|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
219115|NCT01492426|O1|Outcome|Daclatasvir + PEG-IFN Alpha-2a+ Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
219116|NCT01492426|O2|Outcome|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200mg per day was administered twice daily with food.
219402|NCT01491607|O3|Outcome|BioThrax 1st Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
220855|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
219117|NCT01492426|O1|Outcome|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
219118|NCT01492426|O2|Outcome|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
219119|NCT01492426|O1|Outcome|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000 – 1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
219120|NCT01492426|O2|Outcome|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
219121|NCT01492426|O1|Outcome|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
219122|NCT01492426|E2|Reported Event|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food
219123|NCT01492426|E1|Reported Event|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day)
219124|NCT01492400|B3|Baseline|Total|Total of all reporting groups
219125|NCT01492400|B2|Baseline|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
219126|NCT01492400|B1|Baseline|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
219127|NCT01492400|P2|Participant Flow|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
219128|NCT01492400|P1|Participant Flow|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
219129|NCT01492400|O2|Outcome|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
219130|NCT01492400|O1|Outcome|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
219131|NCT01492400|O2|Outcome|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
219132|NCT01492400|O1|Outcome|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
219133|NCT01492400|O2|Outcome|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
219134|NCT01492400|O1|Outcome|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
219135|NCT01492400|E2|Reported Event|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
219136|NCT01492400|E1|Reported Event|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
219137|NCT01492309|B3|Baseline|Total|Total of all reporting groups
219138|NCT01492309|B2|Baseline|Sham TMS|11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
219139|NCT01492309|B1|Baseline|Active TMS|11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
219140|NCT01492309|P2|Participant Flow|Sham TMS|11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
219141|NCT01492309|P1|Participant Flow|Active TMS|11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
219142|NCT01492309|O2|Outcome|Sham TMS|11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
219143|NCT01492309|O1|Outcome|Active TMS|11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
219144|NCT01492309|O2|Outcome|Sham TMS|11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
219145|NCT01492309|O1|Outcome|Active TMS|11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
219146|NCT01492309|E2|Reported Event|Sham TMS|11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
219147|NCT01492309|E1|Reported Event|Active TMS|11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
219148|NCT01492088|B4|Baseline|Total|Total of all reporting groups
220856|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
219149|NCT01492088|B3|Baseline|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219150|NCT01492088|B2|Baseline|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219151|NCT01492088|B1|Baseline|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
219152|NCT01492088|P3|Participant Flow|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219153|NCT01492088|P2|Participant Flow|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219154|NCT01492088|P1|Participant Flow|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
219155|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219156|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
219157|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219158|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
219159|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219160|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
219161|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219162|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219163|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
219164|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219165|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219166|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
219167|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219168|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219169|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
219170|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219171|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219172|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
219173|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219174|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219175|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
219176|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219177|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219178|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
219179|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219180|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219181|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
219182|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219183|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219184|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
219185|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
233127|NCT01449955|E2|Reported Event|Placebo|Placebo arm
219186|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219187|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
219188|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219189|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
219190|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219191|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219192|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
219193|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219194|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r Hodgkin Lymphoma (HL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219195|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
219196|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219197|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
219198|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219199|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
219200|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219201|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
219202|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219203|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
219204|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219205|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
219598|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
219206|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219207|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
219208|NCT01492088|E3|Reported Event|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219209|NCT01492088|E2|Reported Event|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
219210|NCT01492088|E1|Reported Event|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
219211|NCT01491984|B3|Baseline|Total|Total of all reporting groups
219212|NCT01491984|B2|Baseline|Intubation Order MAC/Levitan|A size 7.0-mm endotracheal tube with a malleable stylet was used to facilitate Macintosh intubation (standard practice).
219213|NCT01491984|B1|Baseline|Intubation Order Levitan/MAC|The LFS is used to guide and confirm endotracheal placement of endotracheal tubes during routine laryngoscopy.
219214|NCT01491984|P2|Participant Flow|Macintosh/Levitan FPS Laryngoscope Intubation Order|"traditional MAC intubation~laryngoscopy view with MAC :"
219215|NCT01491984|P1|Participant Flow|Levitan FPS/Mac Laryngoscope Intubation Order|"Intubation with Levitan~laryngoscopy view with Levitan :"
219216|NCT01491984|O2|Outcome|MAC/Levitan Intubation|Laryngoscopy with MAC then Levitan
219217|NCT01491984|O1|Outcome|Levitan/MAC Intubation|Laryngoscopy with Levitan, then MAC
219218|NCT01491984|E2|Reported Event|Macintosh Intubation|A size 7.0-mm endotracheal tube with a malleable stylet was used to facilitate Macintosh intubation (standard practice)
219219|NCT01491984|E1|Reported Event|Levitan FPS Intubation|The LFS is used to guide and confirm endotracheal placement of endotracheal tubes during routine laryngoscopy.
219220|NCT01491958|B3|Baseline|Total|Total of all reporting groups
219221|NCT01491958|B2|Baseline|Donor|Related donors will receive atorvastatin 40 mg/day orally at least 14 days before anticipated first day of stem cell leukapheresis (LP) until successful completion of leukapheresis according to institutional guidelines. Peripheral blood stem cells will not be manipulated or T-depleted prior to administration.
219222|NCT01491958|B1|Baseline|Patients|Patients will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first. Standard post transplant care will be administered.
219223|NCT01491958|P2|Participant Flow|Donors|Related donors will receive atorvastatin 40 mg/day orally at least 14 days before anticipated first day of stem cell leukapheresis (LP) until successful completion of leukapheresis according to institutional guidelines. Peripheral blood stem cells will not be manipulated or T-depleted prior to administration.
219224|NCT01491958|P1|Participant Flow|Patients|Patients will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first. Standard post transplant care will be administered.
219225|NCT01491958|O1|Outcome|Patients|"Patients will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first. Standard post transplant care will be administered.~atorvastatin: donors-will receive atorvastatin 40 mg/day orally at least 14 days before anticipated first day of stem cell leukapheresis (LP) until successful completion of leukapheresis according to institutional guidelines. Patients-will receive"
219226|NCT01491958|O1|Outcome|Patients|Patients will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first. Standard post transplant care will be administered.
219227|NCT01491958|O1|Outcome|Patients|Patients will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first. Standard post transplant care will be administered.
219403|NCT01491607|O2|Outcome|BioThrax 1st Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
233128|NCT01449955|E1|Reported Event|Rapamycin|15mg Rapamycin
219228|NCT01491958|O1|Outcome|Patients|Patients will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first. Standard post transplant care will be administered.
219229|NCT01491958|O1|Outcome|Patients|Patients will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first. Standard post transplant care will be administered.
219230|NCT01491958|E1|Reported Event|Patients|Patients will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first. Standard post transplant care will be administered.
219231|NCT01491919|B4|Baseline|Total|Total of all reporting groups
219232|NCT01491919|B3|Baseline|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
219233|NCT01491919|B2|Baseline|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
219234|NCT01491919|B1|Baseline|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
219235|NCT01491919|P3|Participant Flow|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
219236|NCT01491919|P2|Participant Flow|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
219237|NCT01491919|P1|Participant Flow|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
219238|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
219239|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
219240|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
219241|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
219242|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
219243|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
219244|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
219245|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
219246|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
219247|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
219248|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
219249|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
219250|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
219251|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
219252|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
219253|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
219254|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
219255|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
219256|NCT01491919|O2|Outcome|Lisinopril Standard of Care (SOC)|These protocol participants were enrolled and continued on the lisinopril dose prescribed as standard of care. They were assigned to the appropriate eGFR and dose level stratum (rounding to the closest dose level). Since the lisinopril dose was assigned based on standard of care, a patient was enrolled without regard to open/closed status of the dose stratum in this group. Therefore, over enrollment of a specific dose and eGFR stratum was allowed for participants enrolled he the Lisinopril-naive group to accommodate these valuable low-risk participants already taking lisinopril.
219257|NCT01491919|O1|Outcome|Lisinopril-naive|These protocol participants were not randomized. Instead, the older age group (7-17 years) were first enrolled consecutively into each dose level, starting with the lowest dose level (0.1 mg/kg per day). After enrollment is complete in the low dose level for an eGFR strata, enrollment will commence for the intermediate (0.2 mg/kg per day) dosage in that strata, followed by the high (0.4 mg/kg per day) dosage level. Enrollment for the 2-6 years age group did not begin until enrollment in the older age group (7-17 years) for the low and intermediate dosage level at each eGFR strata is complete.
219258|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
219259|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
219260|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
219261|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
219262|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
219263|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
219264|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
219265|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
219266|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
219267|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
219268|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
219269|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
219270|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
219271|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
219272|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
219273|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
219274|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
219275|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
219276|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
219277|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
219278|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
219279|NCT01491919|E3|Reported Event|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
219280|NCT01491919|E2|Reported Event|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
219281|NCT01491919|E1|Reported Event|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
219282|NCT01491802|B1|Baseline|Randomized Subjects|All 17 randomized subjects.
219283|NCT01491802|P2|Participant Flow|LAMA/LABA, the LAMA|Participants first received the LAMA/LABA combination product (umeclidinium 125 mcg plus vilanterol 25 mcg) once daily for 4 weeks. After a 2 week washout period, they received LAMA alone (umeclidinium 125 mcg) once daily for 4 weeks.
219284|NCT01491802|P1|Participant Flow|LAMA, Then LAMA/LABA|Participants first received LAMA alone (umeclidinium 125 mcg) once daily for 4 weeks. After a 2 week washout period, they received the LAMA/LABA combination product (umeclidinium 125 mcg plus vilanterol 25 mcg) once daily for 4 weeks.
219285|NCT01491802|O2|Outcome|LABA/LAMA Combination|"GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.~GSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks."
219286|NCT01491802|O1|Outcome|LAMA|"GSK573719 is a long-acting muscarinic antagonist~GSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks"
219370|NCT01491607|B4|Baseline|BioThrax - Site 04|Subjects from Site 04 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.
219287|NCT01491802|O2|Outcome|LABA/LAMA Combination|"GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.~GSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks."
219288|NCT01491802|O1|Outcome|LAMA|"GSK573719 is a long-acting muscarinic antagonist~GSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks"
219289|NCT01491802|O2|Outcome|LABA/LAMA Combination|"GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.~GSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks."
219290|NCT01491802|O1|Outcome|LAMA|"GSK573719 is a long-acting muscarinic antagonist~GSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks"
219291|NCT01491802|O2|Outcome|LABA/LAMA Combination|"GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.~GSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks."
219292|NCT01491802|O1|Outcome|LAMA|"GSK573719 is a long-acting muscarinic antagonist~GSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks"
219293|NCT01491802|O2|Outcome|LABA/LAMA Combination|"GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.~GSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks."
219294|NCT01491802|O1|Outcome|LAMA|"GSK573719 is a long-acting muscarinic antagonist~GSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks"
219295|NCT01491802|O2|Outcome|LABA/LAMA Combination|"GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.~GSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks."
219296|NCT01491802|O1|Outcome|LAMA|"GSK573719 is a long-acting muscarinic antagonist~GSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks"
219297|NCT01491802|O2|Outcome|LABA/LAMA Combination|"GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.~GSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks."
219298|NCT01491802|O1|Outcome|LAMA|"GSK573719 is a long-acting muscarinic antagonist~GSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks"
219299|NCT01491802|O2|Outcome|LABA/LAMA Combination|"GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.~GSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks."
219300|NCT01491802|O1|Outcome|LAMA|"GSK573719 is a long-acting muscarinic antagonist~GSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks"
219301|NCT01491802|O2|Outcome|LABA/LAMA Combination|"GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.~GSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks."
219302|NCT01491802|O1|Outcome|LAMA|"GSK573719 is a long-acting muscarinic antagonist~GSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks"
219303|NCT01491802|O2|Outcome|LABA/LAMA Combination|"GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.~GSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks."
219304|NCT01491802|O1|Outcome|LAMA|"GSK573719 is a long-acting muscarinic antagonist~GSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks"
219305|NCT01491802|E3|Reported Event|Washout Period|There was a 2 week washout period between the two treatment arms.
219306|NCT01491802|E2|Reported Event|LABA/LAMA Arm|The 4-week treatment period with once daily inhaled fixed-dose combination of umeclidinium (125 mcg) and vilanterol (25 mcg).
219307|NCT01491802|E1|Reported Event|LAMA Arm|The 4-week treatment period with once daily inhaled umeclidinium (125 mcg).
219308|NCT01491737|B3|Baseline|Total|Total of all reporting groups
219400|NCT01491607|O5|Outcome|BioThrax 1st Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219309|NCT01491737|B2|Baseline|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
219310|NCT01491737|B1|Baseline|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
219311|NCT01491737|P2|Participant Flow|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
219312|NCT01491737|P1|Participant Flow|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
219313|NCT01491737|O2|Outcome|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
219314|NCT01491737|O1|Outcome|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
219315|NCT01491737|O2|Outcome|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
219316|NCT01491737|O1|Outcome|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
219317|NCT01491737|O2|Outcome|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
219318|NCT01491737|O1|Outcome|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
219583|NCT01491035|B5|Baseline|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
233129|NCT01449929|B3|Baseline|Total|Total of all reporting groups
219319|NCT01491737|O2|Outcome|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
219320|NCT01491737|O1|Outcome|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
219321|NCT01491737|O2|Outcome|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
219322|NCT01491737|O1|Outcome|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
219323|NCT01491737|O2|Outcome|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
219324|NCT01491737|O1|Outcome|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
219325|NCT01491737|O2|Outcome|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
219326|NCT01491737|O1|Outcome|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
219327|NCT01491737|O2|Outcome|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
219328|NCT01491737|O1|Outcome|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
219584|NCT01491035|B4|Baseline|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
219329|NCT01491737|E2|Reported Event|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
219330|NCT01491737|E1|Reported Event|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
219331|NCT01491672|B4|Baseline|Total|Total of all reporting groups
219332|NCT01491672|B3|Baseline|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
219333|NCT01491672|B2|Baseline|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
219334|NCT01491672|B1|Baseline|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
219335|NCT01491672|P3|Participant Flow|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
219336|NCT01491672|P2|Participant Flow|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
219337|NCT01491672|P1|Participant Flow|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
219338|NCT01491672|O4|Outcome|All Participants|All participants received RAD001 10 mg daily.
219339|NCT01491672|O3|Outcome|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
219340|NCT01491672|O2|Outcome|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
219341|NCT01491672|O1|Outcome|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
219342|NCT01491672|O4|Outcome|All Participants|All participants received RAD001 10 mg daily.
219343|NCT01491672|O3|Outcome|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
219344|NCT01491672|O2|Outcome|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
219345|NCT01491672|O1|Outcome|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
219346|NCT01491672|O4|Outcome|All Participants|All participants received RAD001 10 mg daily.
219347|NCT01491672|O3|Outcome|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
219348|NCT01491672|O2|Outcome|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
219349|NCT01491672|O1|Outcome|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
219350|NCT01491672|O4|Outcome|All Participants|All participants received RAD001 10 mg daily.
219351|NCT01491672|O3|Outcome|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
219352|NCT01491672|O2|Outcome|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
219353|NCT01491672|O1|Outcome|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
219354|NCT01491672|O3|Outcome|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
219355|NCT01491672|O2|Outcome|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
219356|NCT01491672|O1|Outcome|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
219357|NCT01491672|O1|Outcome|All Participants|All participants received RAD001 10 mg daily.
219358|NCT01491672|E3|Reported Event|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
219359|NCT01491672|E2|Reported Event|Other Prior Anti VEGF|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
219360|NCT01491672|E1|Reported Event|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
219361|NCT01491633|B1|Baseline|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
219362|NCT01491633|P1|Participant Flow|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
219363|NCT01491633|O1|Outcome|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
219364|NCT01491633|O1|Outcome|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
219365|NCT01491633|O1|Outcome|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
219366|NCT01491633|O1|Outcome|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
219367|NCT01491633|O1|Outcome|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
219368|NCT01491633|E1|Reported Event|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
219369|NCT01491607|B5|Baseline|Total|Total of all reporting groups
236215|NCT01440387|B3|Baseline|Total|Total of all reporting groups
219371|NCT01491607|B3|Baseline|BioThrax - Site 03|Subjects from Site 03 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.
219372|NCT01491607|B2|Baseline|BioThrax - Site 02|Subjects from Site 02 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.
219373|NCT01491607|B1|Baseline|BioThrax - Site 01|Subjects from Site 01 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.
219374|NCT01491607|P1|Participant Flow|BioThrax|Participants 18 to 65 years of age who received at least one dose of BioThrax (0.5 mL) subcutaneously (SC).
219375|NCT01491607|O15|Outcome|BioThrax 3rd Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219376|NCT01491607|O14|Outcome|BioThrax 3rd Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219377|NCT01491607|O13|Outcome|BioThrax 3rd Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219378|NCT01491607|O12|Outcome|BioThrax 3rd Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219379|NCT01491607|O11|Outcome|BioThrax 3rd Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219380|NCT01491607|O10|Outcome|BioThrax 2nd Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219381|NCT01491607|O9|Outcome|BioThrax 2nd Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219382|NCT01491607|O8|Outcome|BioThrax 2nd Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219383|NCT01491607|O7|Outcome|BioThrax 2nd Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219384|NCT01491607|O6|Outcome|BioThrax 2nd Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219385|NCT01491607|O5|Outcome|BioThrax 1st Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219386|NCT01491607|O4|Outcome|BioThrax 1st Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219387|NCT01491607|O3|Outcome|BioThrax 1st Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219388|NCT01491607|O2|Outcome|BioThrax 1st Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219389|NCT01491607|O1|Outcome|BioThrax 1st Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219390|NCT01491607|O15|Outcome|BioThrax 3rd Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219391|NCT01491607|O14|Outcome|BioThrax 3rd Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219392|NCT01491607|O13|Outcome|BioThrax 3rd Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219393|NCT01491607|O12|Outcome|BioThrax 3rd Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219394|NCT01491607|O11|Outcome|BioThrax 3rd Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219395|NCT01491607|O10|Outcome|BioThrax 2nd Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219396|NCT01491607|O9|Outcome|BioThrax 2nd Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219397|NCT01491607|O8|Outcome|BioThrax 2nd Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219398|NCT01491607|O7|Outcome|BioThrax 2nd Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219399|NCT01491607|O6|Outcome|BioThrax 2nd Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219599|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
219404|NCT01491607|O1|Outcome|BioThrax 1st Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219405|NCT01491607|O15|Outcome|BioThrax 3rd Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219406|NCT01491607|O14|Outcome|BioThrax 3rd Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219407|NCT01491607|O13|Outcome|BioThrax 3rd Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219408|NCT01491607|O12|Outcome|BioThrax 3rd Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219409|NCT01491607|O11|Outcome|BioThrax 3rd Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219410|NCT01491607|O10|Outcome|BioThrax 2nd Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219411|NCT01491607|O9|Outcome|BioThrax 2nd Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219412|NCT01491607|O8|Outcome|BioThrax 2nd Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219413|NCT01491607|O7|Outcome|BioThrax 2nd Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219414|NCT01491607|O6|Outcome|BioThrax 2nd Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219415|NCT01491607|O5|Outcome|BioThrax 1st Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219416|NCT01491607|O4|Outcome|BioThrax 1st Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219417|NCT01491607|O3|Outcome|BioThrax 1st Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219418|NCT01491607|O2|Outcome|BioThrax 1st Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219419|NCT01491607|O1|Outcome|BioThrax 1st Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219420|NCT01491607|O15|Outcome|BioThrax 3rd Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219421|NCT01491607|O14|Outcome|BioThrax 3rd Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219422|NCT01491607|O13|Outcome|BioThrax 3rd Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219423|NCT01491607|O12|Outcome|BioThrax 3rd Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219424|NCT01491607|O11|Outcome|BioThrax 3rd Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219425|NCT01491607|O10|Outcome|BioThrax 2nd Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219426|NCT01491607|O9|Outcome|BioThrax 2nd Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219427|NCT01491607|O8|Outcome|BioThrax 2nd Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219428|NCT01491607|O7|Outcome|BioThrax 2nd Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219429|NCT01491607|O6|Outcome|BioThrax 2nd Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219430|NCT01491607|O5|Outcome|BioThrax 1st Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219431|NCT01491607|O4|Outcome|BioThrax 1st Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219432|NCT01491607|O3|Outcome|BioThrax 1st Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219433|NCT01491607|O2|Outcome|BioThrax 1st Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219842|NCT01490632|O4|Outcome|Part D: Baricitinib 10 mg - Retreatment|Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219434|NCT01491607|O1|Outcome|BioThrax 1st Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
219435|NCT01491607|O11|Outcome|BioThrax - Site 04|Participants enrolled at Site 04, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
219436|NCT01491607|O10|Outcome|BioThrax - Site 03|Participants enrolled at Site 03, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
219437|NCT01491607|O9|Outcome|BioThrax - Site 02|Participants enrolled at Site 02, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
219438|NCT01491607|O8|Outcome|BioThrax - Site 01|Participants enrolled at Site 01, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
219439|NCT01491607|O7|Outcome|BioThrax - Non-Caucasian|Non-Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
219440|NCT01491607|O6|Outcome|BioThrax - Caucasian|Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
219441|NCT01491607|O5|Outcome|BioThrax - > 30 Years of Age|Participants > 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
219442|NCT01491607|O4|Outcome|BioThrax - ≤ 30 Years of Age|Participants ≤ 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
219443|NCT01491607|O3|Outcome|BioThrax - Female|Female participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
219444|NCT01491607|O2|Outcome|BioThrax - Male|Male participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
219445|NCT01491607|O1|Outcome|BioThrax - Days 63-100 Immunogenicity|Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
219446|NCT01491607|O11|Outcome|BioThrax - Site 04|Participants enrolled at Site 04, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
219447|NCT01491607|O10|Outcome|BioThrax - Site 03|Participants enrolled at Site 03, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
219585|NCT01491035|B3|Baseline|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
219448|NCT01491607|O9|Outcome|BioThrax - Site 02|Participants enrolled at Site 02, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
219449|NCT01491607|O8|Outcome|BioThrax - Site 01|Participants enrolled at Site 01, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
219450|NCT01491607|O7|Outcome|BioThrax - Non-Caucasian|Non-Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
219451|NCT01491607|O6|Outcome|BioThrax - Caucasian|Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
219452|NCT01491607|O5|Outcome|BioThrax - > 30 Years of Age|Participants > 30 Years in age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
219453|NCT01491607|O4|Outcome|BioThrax - ≤ 30 Years of Age|Participants ≤ 30 Years in age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
219454|NCT01491607|O3|Outcome|BioThrax - Female|Female participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
219455|NCT01491607|O2|Outcome|BioThrax - Male|Male participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
219456|NCT01491607|O1|Outcome|BioThrax - Day 70|Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
219457|NCT01491607|O11|Outcome|BioThrax - Site 04|Participants enrolled at Site 04 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
219458|NCT01491607|O10|Outcome|BioThrax - Site 03|Participants enrolled at Site 03 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
219459|NCT01491607|O9|Outcome|BioThrax - Site 02|Participants enrolled at Site 02 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
219460|NCT01491607|O8|Outcome|BioThrax - Site 01|Participants enrolled at Site 01 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
219461|NCT01491607|O7|Outcome|BioThrax - Non-Caucasian|Non-Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..
219462|NCT01491607|O6|Outcome|BioThrax - Caucasian|Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..
219586|NCT01491035|B2|Baseline|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
219463|NCT01491607|O5|Outcome|BioThrax- > 30 Years of Age|Participants > 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
219464|NCT01491607|O4|Outcome|BioThrax - ≤ 30 Years of Age|Participants ≤ 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..
219465|NCT01491607|O3|Outcome|BioThrax - Female|Female participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..
219466|NCT01491607|O2|Outcome|BioThrax - Male|Male participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..
219467|NCT01491607|O1|Outcome|BioThrax|Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
219468|NCT01491607|E1|Reported Event|ITT Population|Participants 18 to 65 years of age who received at least one dose of BioThrax (0.5 mL) subcutaneously (SC).
219469|NCT01491490|B3|Baseline|Total|Total of all reporting groups
219470|NCT01491490|B2|Baseline|Placebo|Taken as 6 capsules once daily, matched to taste and look like the active study medication.
219471|NCT01491490|B1|Baseline|GWP42003 : GWP42004 (40:1)|Active study medication as 4 capsules GWP42003 and 2 capsules GWP42004 once daily.
219472|NCT01491490|P2|Participant Flow|Placebo|Taken as 6 capsules, matched to taste and look like the active study medication.
219473|NCT01491490|P1|Participant Flow|GWP42003 : GWP42004 (40:1)|Active study medication as 4 capsules GWP42003 and 2 capsules GWP42004 once daily.
219474|NCT01491490|O2|Outcome|Placebo|Taken as 6 capsules once daily, matched to taste and look like the active study medication.
219475|NCT01491490|O1|Outcome|GWP42003 : GWP42004 (40:1)|Active study medication as 4 capsules GWP42003 and 2 capsules GWP42004 once daily.
219476|NCT01491490|E2|Reported Event|Placebo|Taken as 6 capsules once daily, matched to taste and look like the active study medication.
219477|NCT01491490|E1|Reported Event|GWP42003 : GWP42004 (40:1)|Active study medication as 4 capsules GWP42003 and 2 capsules GWP42004 once daily.
219478|NCT01491178|B1|Baseline|Patients With NVAF|Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d)
219479|NCT01491178|P1|Participant Flow|Patients With NVAF|Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d)
219480|NCT01491178|O1|Outcome|Patients With NVAF|Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d)
219481|NCT01491178|O1|Outcome|Patients With NVAF|Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d)
219482|NCT01491178|E1|Reported Event|Patients With NVAF|Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d)
219483|NCT01491113|B6|Baseline|Total|Total of all reporting groups
219484|NCT01491113|B5|Baseline|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
219485|NCT01491113|B4|Baseline|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
219486|NCT01491113|B3|Baseline|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
219487|NCT01491113|B2|Baseline|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetics (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
219488|NCT01491113|B1|Baseline|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
219489|NCT01491113|P5|Participant Flow|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetics (PK): Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
219490|NCT01491113|P4|Participant Flow|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
219491|NCT01491113|P3|Participant Flow|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
219492|NCT01491113|P2|Participant Flow|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
219493|NCT01491113|P1|Participant Flow|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
219494|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetics (PK) analysis: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
219495|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
219496|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
219497|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
219498|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
219499|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
219500|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
219501|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
219502|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
219503|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
219504|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
220857|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
219505|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
219506|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
219507|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
219508|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
219509|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
219510|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
219511|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
219512|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
219513|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
219514|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
219515|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
219587|NCT01491035|B1|Baseline|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
219588|NCT01491035|P8|Participant Flow|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
219516|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
219517|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
219518|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
219519|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
219520|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
219521|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
219522|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
219523|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
219524|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
219525|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
219526|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
220858|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
219527|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
219528|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
219529|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
219530|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
219531|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
219532|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
219533|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
219534|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
219535|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
219536|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
219537|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
219589|NCT01491035|P7|Participant Flow|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
219590|NCT01491035|P6|Participant Flow|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
219538|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
219539|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
219540|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
219541|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
219542|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
219543|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
219544|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
219545|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
219546|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
219547|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
219548|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
219591|NCT01491035|P5|Participant Flow|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
219592|NCT01491035|P4|Participant Flow|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
219549|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
219550|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
219551|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
219552|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
219553|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
219554|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
219555|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetics (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
219556|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
219557|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
219593|NCT01491035|P3|Participant Flow|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
219594|NCT01491035|P2|Participant Flow|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
236277|NCT01440322|B3|Baseline|Total|Total of all reporting groups
219558|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
219559|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
219560|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
219561|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
219562|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
219563|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
219564|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
219565|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
219566|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
219567|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
219568|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
219595|NCT01491035|P1|Participant Flow|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
219596|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
219569|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
219570|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
219571|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
219572|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
219573|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
219574|NCT01491113|E5|Reported Event|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
219575|NCT01491113|E4|Reported Event|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
219576|NCT01491113|E3|Reported Event|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
219577|NCT01491113|E2|Reported Event|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetics (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
219578|NCT01491113|E1|Reported Event|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
219579|NCT01491035|B9|Baseline|Total|Total of all reporting groups
219580|NCT01491035|B8|Baseline|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
219581|NCT01491035|B7|Baseline|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
219582|NCT01491035|B6|Baseline|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
240839|NCT01426230|E1|Reported Event|Open Label - Both Cohorts|
219600|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
219601|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
219602|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
219603|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
219604|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
219605|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
219606|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
219607|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
219608|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
219609|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
219610|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
219611|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
219612|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
219613|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
219614|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
219615|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
219616|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
219617|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
219618|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
219619|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
219620|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
219621|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
219622|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
219623|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
219624|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
219625|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
219626|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
219627|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
219628|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
219629|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
219630|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
219631|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
219632|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
219633|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
219634|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
219635|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
219636|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
219637|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
219638|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
219639|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
219640|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
219641|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
219642|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
219643|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
240840|NCT01426113|B3|Baseline|Total|Total of all reporting groups
219644|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
219645|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
219646|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
219647|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
219648|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
219649|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
219650|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
219651|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
219652|NCT01491035|E8|Reported Event|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
219653|NCT01491035|E7|Reported Event|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
219654|NCT01491035|E6|Reported Event|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
219655|NCT01491035|E5|Reported Event|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
219656|NCT01491035|E4|Reported Event|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
219657|NCT01491035|E3|Reported Event|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
219658|NCT01491035|E2|Reported Event|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
219659|NCT01491035|E1|Reported Event|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
219660|NCT01491022|B3|Baseline|Total|Total of all reporting groups
219661|NCT01491022|B2|Baseline|Placebo Then Ampyra|Placebo for 4 weeks followed by 2 weeks washout followed by Ampyra 10 mg po bid for 4 weeks
219662|NCT01491022|B1|Baseline|Ampyra Then Placebo|Ampyra 10 mg po BID for 4 weeks followed by 2 weeks washout followed by 4 weeks placebo
219663|NCT01491022|P2|Participant Flow|Placebo Then Ampyra|placebo for 4 weeks followed by 2 weeks washout followed by 4 weeks Ampyra 10 mg po BID
219664|NCT01491022|P1|Participant Flow|Ampyra Then Placebo|Ampyra 10 mg po BID for 4 weeks followed by 2 weeks washout followed by 4 weeks placebo
219665|NCT01491022|O2|Outcome|Placebo|"placebo 4 weeks followed by Ampyra 10 mg po BID~placebo first, then Ampyra: placebo"
219666|NCT01491022|O1|Outcome|Ampyra|"Ampyra 10 mg po BID for 4 weeks followed by placebo 4 weeks~Ampyra first, then Placebo: 10 mg po bid for 4 weeks followed by placebo 4 weeks."
219667|NCT01491022|O2|Outcome|Placebo Then Ampyra|placebo for 4 weeks followed by 2 weeks washout followed by 4 weeks Ampyra 10 mg po BID
219668|NCT01491022|O1|Outcome|Ampyra Then Placebo|Ampyra 10 mg po BID for 4 weeks followed by 2 weeks washout followed by 4 weeks placebo
219669|NCT01491022|O2|Outcome|Placebo Then Ampyra|placebo for 4 weeks followed by 2 weeks washout followed by 4 weeks Ampyra 10 mg po BID
219670|NCT01491022|O1|Outcome|Ampyra Then Placebo|Ampyra 10 mg po BID for 4 weeks followed by 2 weeks washout followed by 4 weeks placebo
219671|NCT01491022|O2|Outcome|Placebo Then Ampyra|placebo for 4 weeks followed by 2 weeks washout followed by 4 weeks Ampyra 10 mg po BID
219672|NCT01491022|O1|Outcome|Ampyra Then Placebo|Ampyra 10 mg po BID for 4 weeks followed by 2 weeks washout followed by 4 weeks placebo
219673|NCT01491022|O2|Outcome|Placebo|"placebo 4 weeks followed by Ampyra 10 mg po BID~placebo first, then Ampyra: placebo"
219674|NCT01491022|O1|Outcome|Ampyra|"Ampyra 10 mg po BID for 4 weeks followed by placebo 4 weeks~Ampyra first, then Placebo: 10 mg po bid for 4 weeks followed by placebo 4 weeks."
219675|NCT01491022|O2|Outcome|Placebo|placebo: placebo
219676|NCT01491022|O1|Outcome|Ampyra|"Ampyra 10 mg po BID~Dalfampridine: 10 mg po bid for 4 weeks"
219677|NCT01491022|E2|Reported Event|Placebo|placebo: placebo
219678|NCT01491022|E1|Reported Event|Ampyra|"Ampyra 10 mg po BID~Dalfampridine: 10 mg po bid for 4 weeks"
219679|NCT01490931|B1|Baseline|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
219680|NCT01490931|P1|Participant Flow|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
219681|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
219682|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
219683|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
219684|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
219685|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
219686|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
219687|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
219688|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
219689|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
219690|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
219691|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
219692|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
219693|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
219694|NCT01490931|E1|Reported Event|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
219695|NCT01490866|B1|Baseline|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (a total of 16 weeks). After 4 cycles, axitinib maintenance will be administered. FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin.~FOLFOX/bevacizumab:~5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;~Leucovorin: 400 mg/m2 given Days 1 and 15 by IV~Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV~Bevacizumab: 5 mg/kg on Days 1 and 15 by;IV~Maintenance:~- Axitinib: 5-mg tablets orally twice per day (PO BID)"
219696|NCT01490866|P1|Participant Flow|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (16 weeks). After 4 cycles, axitinib maintenance will be administered starting on Week 17. Maintenance treatment will continue until disease progression or intolerable toxicity occurs.~FOLFOX/bevacizumab ( FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin):~5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;~Leucovorin: 400 mg/m2 given Days 1 and 15 by IV~Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV~Bevacizumab: 5 mg/kg on Days 1 and 15 by IV~Maintenance:~- Axitinib: 5-mg tablets orally twice per day on Days 1 thru 28 of each cycle until disease progression or unacceptable toxicity occurs."
219697|NCT01490866|O2|Outcome|Axitinib|All patients who received at least one dose of axitinib
219698|NCT01490866|O1|Outcome|FOLFOX/Bevacizumab|All patients who received at least one dose of FOLFOX/bevacizumab
219699|NCT01490866|O1|Outcome|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (16 weeks). After 4 cycles, axitinib maintenance will be administered starting on Week 17. Maintenance treatment will continue until disease progression or intolerable toxicity occurs.~FOLFOX/bevacizumab ( FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin):~5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;~Leucovorin: 400 mg/m2 given Days 1 and 15 by IV~Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV~Bevacizumab: 5 mg/kg on Days 1 and 15 by IV~Maintenance:~- Axitinib: 5-mg tablets orally twice per day on Days 1 thru 28 of each cycle until disease progression or unacceptable toxicity occurs."
219700|NCT01490866|O1|Outcome|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (16 weeks). After 4 cycles, axitinib maintenance will be administered starting on Week 17. Maintenance treatment will continue until disease progression or intolerable toxicity occurs.~FOLFOX/bevacizumab ( FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin):~5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;~Leucovorin: 400 mg/m2 given Days 1 and 15 by IV~Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV~Bevacizumab: 5 mg/kg on Days 1 and 15 by IV~Maintenance:~- Axitinib: 5-mg tablets orally twice per day on Days 1 thru 28 of each cycle until disease progression or unacceptable toxicity occurs."
219701|NCT01490866|O1|Outcome|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (a total of 16 weeks). After 4 cycles, axitinib maintenance will be administered. FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin.~FOLFOX/bevacizumab:~5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;~Leucovorin: 400 mg/m2 given Days 1 and 15 by IV~Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV~Bevacizumab: 5 mg/kg on Days 1 and 15 by;IV~Maintenance:~- Axitinib: 5-mg tablets orally twice per day (PO BID)"
219702|NCT01490866|O1|Outcome|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (16 weeks). After 4 cycles, axitinib maintenance will be administered starting on Week 17. Maintenance treatment will continue until disease progression or intolerable toxicity occurs.~FOLFOX/bevacizumab ( FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin):~5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;~Leucovorin: 400 mg/m2 given Days 1 and 15 by IV~Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV~Bevacizumab: 5 mg/kg on Days 1 and 15 by IV~Maintenance:~- Axitinib: 5-mg tablets orally twice per day on Days 1 thru 28 of each cycle until disease progression or unacceptable toxicity occurs."
219703|NCT01490866|E1|Reported Event|FOLFOX/Bevacizumab and Axitinib|
219704|NCT01490840|B3|Baseline|Total|Total of all reporting groups
220701|NCT01488578|O1|Outcome|Mild|Participants with mild OAB who took tolterodine according to Japanese Package Insert.
219705|NCT01490840|B2|Baseline|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
219706|NCT01490840|B1|Baseline|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
219707|NCT01490840|P2|Participant Flow|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
219708|NCT01490840|P1|Participant Flow|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
219709|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
219710|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
219711|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
219712|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
219731|NCT01490697|B1|Baseline|Placebo Plus Placebo|Placebo-matching DCS 100 mg capsule orally followed by placebo-matching mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
220702|NCT01488578|O1|Outcome|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
219713|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
219714|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
219715|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
219716|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
219717|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
219718|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
219719|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
219720|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
219732|NCT01490697|P2|Participant Flow|Mifepristone Plus d-Cycloserine (DCS)|DCS 100 mg capsule orally followed by mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
219843|NCT01490632|O3|Outcome|Part D: Baricitinib 8 mg - Retreatment|Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219721|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
219722|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
219723|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
219724|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
219725|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
219726|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
219727|NCT01490840|E2|Reported Event|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
219728|NCT01490840|E1|Reported Event|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
219729|NCT01490697|B3|Baseline|Total|Total of all reporting groups
219730|NCT01490697|B2|Baseline|Mifepristone Plus d-Cycloserine (DCS)|DCS 100 mg capsule orally followed by mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
242300|NCT01421667|O4|Outcome|CD30u DLBCL, BV|
219733|NCT01490697|P1|Participant Flow|Placebo Plus Placebo|Placebo-matching DCS 100 mg capsule orally followed by placebo-matching mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
219734|NCT01490697|O2|Outcome|Mifepristone Plus d-Cycloserine (DCS)|DCS 100 mg capsule orally followed by mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
219735|NCT01490697|O1|Outcome|Placebo Plus Placebo|Placebo-matching DCS 100 mg capsule orally followed by placebo-matching mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
219736|NCT01490697|O2|Outcome|Mifepristone Plus d-Cycloserine (DCS)|DCS 100 mg capsule orally followed by mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
219737|NCT01490697|O1|Outcome|Placebo Plus Placebo|Placebo-matching DCS 100 mg capsule orally followed by placebo-matching mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
219738|NCT01490697|E2|Reported Event|Mifepristone Plus d-Cycloserine (DCS)|DCS 100 mg capsule orally followed by mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
219739|NCT01490697|E1|Reported Event|Placebo Plus Placebo|Placebo-matching DCS 100 mg capsule orally followed by placebo-matching mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
219740|NCT01490632|B6|Baseline|Total|Total of all reporting groups
219741|NCT01490632|B5|Baseline|Part A: Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
219742|NCT01490632|B4|Baseline|Part A: Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
219743|NCT01490632|B3|Baseline|Part A: Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219744|NCT01490632|B2|Baseline|Part A: Baricitinib 2 mg|Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219745|NCT01490632|B1|Baseline|Part A: Placebo|Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219746|NCT01490632|P20|Participant Flow|Part D: Baricitinib 10 mg - Retreatment|Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219747|NCT01490632|P19|Participant Flow|Part D: Baricitinib 8 mg - Retreatment|Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219748|NCT01490632|P18|Participant Flow|Part D: Baricitinib 4 mg - Retreatment|Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219749|NCT01490632|P17|Participant Flow|Part D: Baricitinib 2 mg - Retreatment|Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219750|NCT01490632|P16|Participant Flow|Part C: Responder - High Dose to Low Dose|Baricitinib administered 8 mg PO QD re-randomized to baricitinib 4 mg PO QD. Baricitinib administered 10 mg PO QD re-randomized to baricitinib 4 mg PO QD.
219751|NCT01490632|P15|Participant Flow|Part C: Responder - High Dose to Placebo|Baricitinib administered 8 mg or 10 mg PO QD re-randomized to placebo PO QD.
219752|NCT01490632|P14|Participant Flow|Part C: Responder - Low Dose to ½ Low Dose|Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 1 mg or 2 mg PO QD.
219753|NCT01490632|P13|Participant Flow|Part C: Responder - Low Dose to Placebo|Baricitinib 2 mg or 4 mg PO QD re-randomized to placebo PO QD.
219754|NCT01490632|P12|Participant Flow|Part B: Placebo Extension|Placebo PO QD maintained on placebo PO QD.
219755|NCT01490632|P11|Participant Flow|Part B: Partial- and Non-responder - High Dose to High Dose|Baricitinib administered 8 mg or 10 mg PO QD.
219756|NCT01490632|P10|Participant Flow|Part B: Partial- and Non-responder - Low Dose to High Dose|Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
219757|NCT01490632|P9|Participant Flow|Part B: Partial-responder - Low Dose to Low Dose|Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
219758|NCT01490632|P8|Participant Flow|Part B: Partial- and Non-responder - Placebo to High Dose|Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
219759|NCT01490632|P7|Participant Flow|Part B: Responder - High Dose|Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
219760|NCT01490632|P6|Participant Flow|Part B: Responder - Low Dose|Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
219761|NCT01490632|P5|Participant Flow|Part A: Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
219762|NCT01490632|P4|Participant Flow|Part A: Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
219763|NCT01490632|P3|Participant Flow|Part A: Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219764|NCT01490632|P2|Participant Flow|Part A: Baricitinib 2 mg|Baricitinib 2 milligram (mg) administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219765|NCT01490632|P1|Participant Flow|Part A: Placebo|Placebo administered orally (PO) once daily (QD) for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219766|NCT01490632|O4|Outcome|Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
219767|NCT01490632|O3|Outcome|Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks
219768|NCT01490632|O2|Outcome|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219769|NCT01490632|O1|Outcome|Baricitinib 2 mg|Baricitinib 2 milligram (mg) administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219770|NCT01490632|O4|Outcome|Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
219771|NCT01490632|O3|Outcome|Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks
219772|NCT01490632|O2|Outcome|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219773|NCT01490632|O1|Outcome|Baricitinib 2 mg|Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219774|NCT01490632|O4|Outcome|Part C: Responder - High Dose to Low Dose|Baricitinib administered 8 mg PO QD re-randomized to baricitinib 4 mg PO QD. Baricitinib administered 10 mg PO QD re-randomized to baricitinib 4 mg PO QD.
219775|NCT01490632|O3|Outcome|Part C: Responder - High Dose to Placebo|Baricitinib administered 8 mg or 10 mg PO QD re-randomized to placebo PO QD.
219776|NCT01490632|O2|Outcome|Part C: Responder - Low Dose to ½ Low Dose|Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 1 mg or 2 mg PO QD.
219777|NCT01490632|O1|Outcome|Part C: Responder - Low Dose to Placebo|Baricitinib 2 mg or 4 mg PO QD re-randomized to placebo PO QD.
219778|NCT01490632|O4|Outcome|Part D: Baricitinib 10 mg - Retreatment|Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219779|NCT01490632|O3|Outcome|Part D: Baricitinib 8 mg - Retreatment|Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219780|NCT01490632|O2|Outcome|Part D: Baricitinib 4 mg - Retreatment|Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219781|NCT01490632|O1|Outcome|Part D: Baricitinib 2 mg - Retreatment|Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219782|NCT01490632|O7|Outcome|Part B: Placebo Extension|Placebo PO QD maintained on placebo PO QD.
219783|NCT01490632|O6|Outcome|Part B: Partial- and Non-responder - High Dose to High Dose|Baricitinib administered 8 mg or 10 mg PO QD.
219784|NCT01490632|O5|Outcome|Part B: Partial- and Non-responder - Low Dose to High Dose|Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
219785|NCT01490632|O4|Outcome|Part B: Partial-responder - Low Dose to Low Dose|Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
219786|NCT01490632|O3|Outcome|Part B: Partial- and Non-responder - Placebo to High Dose|Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
219787|NCT01490632|O2|Outcome|Part B: Responder - High Dose|Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
219788|NCT01490632|O1|Outcome|Part B: Responder - Low Dose|Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
219789|NCT01490632|O5|Outcome|Part A: Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
219790|NCT01490632|O4|Outcome|Part A: Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
219791|NCT01490632|O3|Outcome|Part A: Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219792|NCT01490632|O2|Outcome|Part A: Baricitinib 2 mg|Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219793|NCT01490632|O1|Outcome|Part A: Placebo|Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219794|NCT01490632|O4|Outcome|Part D: Baricitinib 10 mg - Retreatment|Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219795|NCT01490632|O3|Outcome|Part D: Baricitinib 8 mg - Retreatment|Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219796|NCT01490632|O2|Outcome|Part D: Baricitinib 4 mg - Retreatment|Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219797|NCT01490632|O1|Outcome|Part D: Baricitinib 2 mg - Retreatment|Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219798|NCT01490632|O7|Outcome|Part B: Placebo Extension|Placebo PO QD maintained on placebo PO QD.
219799|NCT01490632|O6|Outcome|Part B: Partial- and Non-responder - High Dose to High Dose|Baricitinib administered 8 mg or 10 mg PO QD.
219800|NCT01490632|O5|Outcome|Part B: Partial- and Non-responder - Low Dose to High Dose|Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
219801|NCT01490632|O4|Outcome|Part B: Partial-responder - Low Dose to Low Dose|Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
219802|NCT01490632|O3|Outcome|Part B: Partial- and Non-responder - Placebo to High Dose|Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
219803|NCT01490632|O2|Outcome|Part B: Responder - High Dose|Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
219805|NCT01490632|O5|Outcome|Part A: Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
219806|NCT01490632|O4|Outcome|Part A: Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
219807|NCT01490632|O3|Outcome|Part A: Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219808|NCT01490632|O2|Outcome|Part A: Baricitinib 2 mg|Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219809|NCT01490632|O1|Outcome|Part A: Placebo|Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219810|NCT01490632|O4|Outcome|Part D: Baricitinib 10 mg - Retreatment|Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219811|NCT01490632|O3|Outcome|Part D: Baricitinib 8 mg - Retreatment|Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219812|NCT01490632|O2|Outcome|Part D: Baricitinib 4 mg - Retreatment|Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219813|NCT01490632|O1|Outcome|Part D: Baricitinib 2 mg - Retreatment|Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219814|NCT01490632|O7|Outcome|Part B: Placebo Extension|Placebo PO QD maintained on placebo PO QD.
219815|NCT01490632|O6|Outcome|Part B: Partial- and Non-responder - High Dose to High Dose|Baricitinib administered 8 mg or 10 mg PO QD.
219816|NCT01490632|O5|Outcome|Part B: Partial- and Non-responder - Low Dose to High Dose|Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
219817|NCT01490632|O4|Outcome|Part B: Partial-responder - Low Dose to Low Dose|Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
219818|NCT01490632|O3|Outcome|Part B: Partial- and Non-responder - Placebo to High Dose|Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
219819|NCT01490632|O2|Outcome|Part B: Responder - High Dose|Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
219820|NCT01490632|O1|Outcome|Part B: Responder - Low Dose|Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
219821|NCT01490632|O5|Outcome|Part A: Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
219822|NCT01490632|O4|Outcome|Part A: Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
219823|NCT01490632|O3|Outcome|Part A: Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219824|NCT01490632|O2|Outcome|Part A: Baricitinib 2 mg|Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks
219825|NCT01490632|O1|Outcome|Part A: Placebo|Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219826|NCT01490632|O4|Outcome|Part D: Baricitinib 10 mg - Retreatment|Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219827|NCT01490632|O3|Outcome|Part D: Baricitinib 8 mg - Retreatment|Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219828|NCT01490632|O2|Outcome|Part D: Baricitinib 4 mg - Retreatment|Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219829|NCT01490632|O1|Outcome|Part D: Baricitinib 2 mg - Retreatment|Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219830|NCT01490632|O7|Outcome|Part B: Placebo Extension|Placebo PO QD maintained on placebo PO QD.
219831|NCT01490632|O6|Outcome|Part B: Partial- and Non-responder - High Dose to High Dose|Baricitinib administered 8 mg or 10 mg PO QD.
219832|NCT01490632|O5|Outcome|Part B: Partial- and Non-responder - Low Dose to High Dose|Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
219833|NCT01490632|O4|Outcome|Part B: Partial-responder - Low Dose to Low Dose|Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
219834|NCT01490632|O3|Outcome|Part B: Partial- and Non-responder - Placebo to High Dose|Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
219835|NCT01490632|O2|Outcome|Part B: Responder - High Dose|Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
219836|NCT01490632|O1|Outcome|Part B: Responder - Low Dose|Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
219837|NCT01490632|O5|Outcome|Part A: Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
219838|NCT01490632|O4|Outcome|Part A: Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
219839|NCT01490632|O3|Outcome|Part A: Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219840|NCT01490632|O2|Outcome|Part A: Baricitinib 2 mg|Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219841|NCT01490632|O1|Outcome|Part A: Placebo|Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219844|NCT01490632|O2|Outcome|Part D: Baricitinib 4 mg - Retreatment|Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219845|NCT01490632|O1|Outcome|Part D: Baricitinib 2 mg - Retreatment|Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219846|NCT01490632|O7|Outcome|Part B: Placebo Extension|Placebo PO QD maintained on placebo PO QD.
219847|NCT01490632|O6|Outcome|Part B: Partial- and Non-responder - High Dose to High Dose|Baricitinib administered 8 mg or 10 mg PO QD.
219848|NCT01490632|O5|Outcome|Part B: Partial- and Non-responder - Low Dose to High Dose|Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
219849|NCT01490632|O4|Outcome|Part B: Partial-responder - Low Dose to Low Dose|Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
219850|NCT01490632|O3|Outcome|Part B: Partial- and Non-responder - Placebo to High Dose|Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
219851|NCT01490632|O2|Outcome|Part B: Responder - High Dose|Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
219852|NCT01490632|O1|Outcome|Part B: Responder - Low Dose|Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
219853|NCT01490632|O5|Outcome|Part A: Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
219854|NCT01490632|O4|Outcome|Part A: Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks
219855|NCT01490632|O3|Outcome|Part A: Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219856|NCT01490632|O2|Outcome|Part A: Baricitinib 2 mg|Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219857|NCT01490632|O1|Outcome|Part A: Placebo|Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219858|NCT01490632|O4|Outcome|Part D: Baricitinib 10 mg - Retreatment|Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219859|NCT01490632|O3|Outcome|Part D: Baricitinib 8 mg - Retreatment|Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219860|NCT01490632|O2|Outcome|Part D: Baricitinib 4 mg - Retreatment|Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219861|NCT01490632|O1|Outcome|Part D: Baricitinib 2 mg - Retreatment|Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
219862|NCT01490632|O7|Outcome|Part B: Placebo Extension|Placebo PO QD maintained on placebo PO QD.
219863|NCT01490632|O6|Outcome|Part B: Partial- and Non-responder - High Dose to High Dose|Baricitinib administered 8 mg or 10 mg PO QD.
219864|NCT01490632|O5|Outcome|Part B: Partial- and Non-responder - Low Dose to High Dose|Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
219865|NCT01490632|O4|Outcome|Part B: Partial-responder - Low Dose to Low Dose|Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
219866|NCT01490632|O3|Outcome|Part B: Partial- and Non-responder - Placebo to High Dose|Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
219867|NCT01490632|O2|Outcome|Part B: Responder - High Dose|Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
219868|NCT01490632|O1|Outcome|Part B: Responder - Low Dose|Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
219869|NCT01490632|O5|Outcome|Part A: Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
219870|NCT01490632|O4|Outcome|Part A: Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
219871|NCT01490632|O3|Outcome|Part A: Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219872|NCT01490632|O2|Outcome|Part A: Baricitinib 2 mg|Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219873|NCT01490632|O1|Outcome|Part A: Placebo|Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219874|NCT01490632|O5|Outcome|Part A: Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
219875|NCT01490632|O4|Outcome|Part A: Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
219876|NCT01490632|O3|Outcome|Part A: Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219877|NCT01490632|O2|Outcome|Part A: Baricitinib 2 mg|Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219878|NCT01490632|O1|Outcome|Part A: Placebo|Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219879|NCT01490632|E13|Reported Event|Follow-up: Ever Used Baricitinib|Participants in follow-up with exposure to any dose of baricitinib during study. No baricitinib received during follow-up.
220736|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
219880|NCT01490632|E12|Reported Event|Follow-up: Always Placebo|Participants in follow-up with exposure to placebo only during the study. No placebo received during follow-up.
219881|NCT01490632|E11|Reported Event|Part D: All Baricitinib Doses|All participant dosages following baricitinib retreatment with Part B efficacious dose for 52 weeks.
219882|NCT01490632|E10|Reported Event|Part C: Baricitinib|All baricitinib participant groups after study drug re-randomized to various doses.
219883|NCT01490632|E9|Reported Event|Part C: Placebo|All placebo participant groups after study drug re-randomized.
219884|NCT01490632|E8|Reported Event|Part B: High Dose|"All participants in the following groups (as described in the Participant Flow):~Responder High Dose~Partial and Non-responder Placebo to High Dose~Partial and Non-responder Low Dose to High Dose~Partial and Non-responder High Dose to High Dose"
219885|NCT01490632|E7|Reported Event|Part B: Low Dose|"All participants in the following groups (as described in the Participant Flow):~Responder Low Dose~Partial Responder Low Dose to Low Dose groups."
219886|NCT01490632|E6|Reported Event|Part B: Placebo|Placebo PO QD maintained on placebo PO QD.
219887|NCT01490632|E5|Reported Event|Part A: Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
219888|NCT01490632|E4|Reported Event|Part A: Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
219889|NCT01490632|E3|Reported Event|Part A: Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219890|NCT01490632|E2|Reported Event|Part A: Baricitinib 2 mg|Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219891|NCT01490632|E1|Reported Event|Part A: Placebo|Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
219892|NCT01490359|B3|Baseline|Total|Total of all reporting groups
219893|NCT01490359|B2|Baseline|Health Promotion Control|"Health Promotion Intervention was designed to increase physical activity, healthful diet, and other behaviors to reduce risk of noncommunicable diseases, including diabetes, hypertension, and cancers.~Health Promotion Control: The health-promotion intervention was designed to control for non-specific features including group interaction and special attention. It was structurally similar to the HIV/STD risk-reduction intervention in that it contained activities similar to the HIV/STD risk-reduction intervention but focused on behaviors linked to the risk of heart disease, hypertension, stroke, diabetes, and certain cancers-leading causes of morbidity and mortality among South Africans. It also consisted of 6 75-minute modules implemented 2 modules per week during 3 weekly sessions led by isiXhosa speaking male facilitators. It was designed to increase fruit and vegetable consumption and physical activity and decrease excessive alcohol consumption."
219894|NCT01490359|B1|Baseline|HIV/STD Risk-reduction|"Men Making a Difference HIV/STD Risk Reduction Intervention was designed to reduce sexual risk behaviors that increase risk of HIV and other sexually transmitted diseases.~Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, it consists of 6 75-minute modules designed to increase beliefs that support condom use; skill and self-efficacy to use condoms; and HIV/STD risk-reduction knowledge. Two modules are implemented in each of 3 weekly sessions. It is highly structured and implemented in small groups of 9 to 15 men led by a male, isiXhosa-speaking facilitators using standardized intervention manuals. It includes interactive exercises, games, brainstorming, role-playing, take-home assignments, group discussions, and videos, produced specifically for the interventions, shot in authentic township settings, including a shebeen (i.e., an informal alcohol outlet)."
219895|NCT01490359|P2|Participant Flow|Health Promotion Control|"Health Promotion Intervention was designed to increase physical activity, healthful diet, and other behaviors to reduce risk of noncommunicable diseases, including diabetes, hypertension, and cancers.~Health Promotion Control: The health-promotion intervention was designed to control for non-specific features including group interaction and special attention. It was structurally similar to the HIV/STD risk-reduction intervention in that it contained activities similar to the HIV/STD risk-reduction intervention but focused on behaviors linked to the risk of heart disease, hypertension, stroke, diabetes, and certain cancers-leading causes of morbidity and mortality among South Africans. It also consisted of 6 75-minute modules implemented 2 modules per week during 3 weekly sessions led by isiXhosa speaking male facilitators. It was designed to increase fruit and vegetable consumption and physical activity and decrease excessive alcohol consumption."
219896|NCT01490359|P1|Participant Flow|HIV/STD Risk-reduction|"Men Making a Difference HIV/STD Risk Reduction Intervention was designed to reduce sexual risk behaviors that increase risk of HIV and other sexually transmitted diseases.~Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, it consists of 6 75-minute modules designed to increase beliefs that support condom use; skill and self-efficacy to use condoms; and HIV/STD risk-reduction knowledge. Two modules are implemented in each of 3 weekly sessions. It is highly structured and implemented in small groups of 9 to 15 men led by a male, isiXhosa-speaking facilitators using standardized intervention manuals. It includes interactive exercises, games, brainstorming, role-playing, take-home assignments, group discussions, and videos, produced specifically for the interventions, shot in authentic township settings, including a shebeen (i.e., an informal alcohol outlet)."
219897|NCT01490359|O2|Outcome|Health Promotion Control|"Health Promotion Intervention was designed to increase physical activity, healthful diet, and other behaviors to reduce risk of noncommunicable diseases, including diabetes, hypertension, and cancers.~Health Promotion Control: The health-promotion intervention was designed to control for non-specific features including group interaction and special attention. It was structurally similar to the HIV/STD risk-reduction intervention in that it contained activities similar to the HIV/STD risk-reduction intervention but focused on behaviors linked to the risk of heart disease, hypertension, stroke, diabetes, and certain cancers-leading causes of morbidity and mortality among South Africans. It also consisted of 6 75-minute modules implemented 2 modules per week during 3 weekly sessions led by isiXhosa speaking male facilitators. It was designed to increase fruit and vegetable consumption and physical activity and decrease excessive alcohol consumption."
219898|NCT01490359|O1|Outcome|HIV/STD Risk-reduction|"Men Making a Difference HIV/STD Risk Reduction Intervention was designed to reduce sexual risk behaviors that increase risk of HIV and other sexually transmitted diseases.~Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, the intervention consists of 6 75-minute modules designed to increase beliefs that support condom use; skill and self-efficacy to use condoms; and HIV/STD risk-reduction knowledge. Two modules are implemented in each of 3 weekly sessions. It is highly structured and implemented in small groups of 9 to 15 men led by a male, isiXhosa-speaking facilitators using standardized intervention manuals. It includes interactive exercises, games, brainstorming, role-playing, take-home assignments, group discussions, and videos, produced specifically for the interventions, shot in authentic township settings, including a shebeen (i.e., an informal alcohol outlet)."
219899|NCT01490359|O2|Outcome|Health Promotion Control|"Health Promotion Intervention was designed to increase physical activity, healthful diet, and other behaviors to reduce risk of noncommunicable diseases, including diabetes, hypertension, and cancers.~Health Promotion Control: The health-promotion intervention was designed to control for non-specific features including group interaction and special attention. It was structurally similar to the HIV/STD risk-reduction intervention in that it contained activities similar to the HIV/STD risk-reduction intervention but focused on behaviors linked to the risk of heart disease, hypertension, stroke, diabetes, and certain cancers-leading causes of morbidity and mortality among South Africans. It also consisted of 6 75-minute modules implemented 2 modules per week during 3 weekly sessions led by isiXhosa speaking male facilitators. It was designed to increase fruit and vegetable consumption and physical activity and decrease excessive alcohol consumption."
219900|NCT01490359|O1|Outcome|HIV/STD Risk-reduction|"Men Making a Difference HIV/STD Risk Reduction Intervention was designed to reduce sexual risk behaviors that increase risk of HIV and other sexually transmitted diseases.~Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, the intervention consists of 6 75-minute modules designed to increase beliefs that support condom use; skill and self-efficacy to use condoms; and HIV/STD risk-reduction knowledge. Two modules are implemented in each of 3 weekly sessions. It is highly structured and implemented in small groups of 9 to 15 men led by a male, isiXhosa-speaking facilitators using standardized intervention manuals. It includes interactive exercises, games, brainstorming, role-playing, take-home assignments, group discussions, and videos, produced specifically for the interventions, shot in authentic township settings, including a shebeen (i.e., an informal alcohol outlet)."
219901|NCT01490359|O2|Outcome|Health Promotion Control|"Health Promotion Intervention was designed to increase physical activity, healthful diet, and other behaviors to reduce risk of noncommunicable diseases, including diabetes, hypertension, and cancers.~Health Promotion Control: The health-promotion intervention was designed to control for non-specific features including group interaction and special attention. It was structurally similar to the HIV/STD risk-reduction intervention in that it contained activities similar to the HIV/STD risk-reduction intervention but focused on behaviors linked to the risk of heart disease, hypertension, stroke, diabetes, and certain cancers-leading causes of morbidity and mortality among South Africans. It also consisted of 6 75-minute modules implemented 2 modules per week during 3 weekly sessions led by isiXhosa speaking male facilitators. It was designed to increase fruit and vegetable consumption and physical activity and decrease excessive alcohol consumption."
219902|NCT01490359|O1|Outcome|HIV/STD Risk-reduction|"Men Making a Difference HIV/STD Risk Reduction Intervention was designed to reduce sexual risk behaviors that increase risk of HIV and other sexually transmitted diseases.~Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, the intervention consists of 6 75-minute modules designed to increase beliefs that support condom use; skill and self-efficacy to use condoms; and HIV/STD risk-reduction knowledge. Two modules are implemented in each of 3 weekly sessions. It is highly structured and implemented in small groups of 9 to 15 men led by a male, isiXhosa-speaking facilitators using standardized intervention manuals. It includes interactive exercises, games, brainstorming, role-playing, take-home assignments, group discussions, and videos, produced specifically for the interventions, shot in authentic township settings, including a shebeen (i.e., an informal alcohol outlet)."
219903|NCT01490359|O2|Outcome|Health Promotion Control|"Health Promotion Intervention was designed to increase physical activity, healthful diet, and other behaviors to reduce risk of noncommunicable diseases, including diabetes, hypertension, and cancers.~Health Promotion Control: The health-promotion intervention was designed to control for non-specific features including group interaction and special attention. It was structurally similar to the HIV/STD risk-reduction intervention in that it contained activities similar to the HIV/STD risk-reduction intervention but focused on behaviors linked to the risk of heart disease, hypertension, stroke, diabetes, and certain cancers-leading causes of morbidity and mortality among South Africans. It also consisted of 6 75-minute modules implemented 2 modules per week during 3 weekly sessions led by isiXhosa speaking male facilitators. It was designed to increase fruit and vegetable consumption and physical activity and decrease excessive alcohol consumption."
219904|NCT01490359|O1|Outcome|HIV/STD Risk-reduction|"Men Making a Difference HIV/STD Risk Reduction Intervention was designed to reduce sexual risk behaviors that increase risk of HIV and other sexually transmitted diseases.~Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, the intervention consists of 6 75-minute modules designed to increase beliefs that support condom use; skill and self-efficacy to use condoms; and HIV/STD risk-reduction knowledge. Two modules are implemented in each of 3 weekly sessions. It is highly structured and implemented in small groups of 9 to 15 men led by a male, isiXhosa-speaking facilitators using standardized intervention manuals. It includes interactive exercises, games, brainstorming, role-playing, take-home assignments, group discussions, and videos, produced specifically for the interventions, shot in authentic township settings, including a shebeen (i.e., an informal alcohol outlet)."
219927|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220200|NCT01490125|O2|Outcome|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
219905|NCT01490359|O2|Outcome|Health Promotion Control|"Health Promotion Intervention was designed to increase physical activity, healthful diet, and other behaviors to reduce risk of noncommunicable diseases, including diabetes, hypertension, and cancers.~Health Promotion Control: The health-promotion intervention was designed to control for non-specific features including group interaction and special attention. It was structurally similar to the HIV/STD risk-reduction intervention in that it contained activities similar to the HIV/STD risk-reduction intervention but focused on behaviors linked to the risk of heart disease, hypertension, stroke, diabetes, and certain cancers-leading causes of morbidity and mortality among South Africans. It also consisted of 6 75-minute modules implemented 2 modules per week during 3 weekly sessions led by isiXhosa speaking male facilitators. It was designed to increase fruit and vegetable consumption and physical activity and decrease excessive alcohol consumption."
219906|NCT01490359|O1|Outcome|HIV/STD Risk-reduction|"Men Making a Difference HIV/STD Risk Reduction Intervention was designed to reduce sexual risk behaviors that increase risk of HIV and other sexually transmitted diseases.~Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, the intervention consists of 6 75-minute modules designed to increase beliefs that support condom use; skill and self-efficacy to use condoms; and HIV/STD risk-reduction knowledge. Two modules are implemented in each of 3 weekly sessions. It is highly structured and implemented in small groups of 9 to 15 men led by a male, isiXhosa-speaking facilitators using standardized intervention manuals. It includes interactive exercises, games, brainstorming, role-playing, take-home assignments, group discussions, and videos, produced specifically for the interventions, shot in authentic township settings, including a shebeen (i.e., an informal alcohol outlet)."
219907|NCT01490359|O2|Outcome|Health Promotion Control|"Health Promotion Intervention was designed to increase physical activity, healthful diet, and other behaviors to reduce risk of noncommunicable diseases, including diabetes, hypertension, and cancers.~Health Promotion Control: The health-promotion intervention was designed to control for non-specific features including group interaction and special attention. It was structurally similar to the HIV/STD risk-reduction intervention in that it contained activities similar to the HIV/STD risk-reduction intervention but focused on behaviors linked to the risk of heart disease, hypertension, stroke, diabetes, and certain cancers-leading causes of morbidity and mortality among South Africans. It also consisted of 6 75-minute modules implemented 2 modules per week during 3 weekly sessions led by isiXhosa speaking male facilitators. It was designed to increase fruit and vegetable consumption and physical activity and decrease excessive alcohol consumption."
219908|NCT01490359|O1|Outcome|HIV/STD Risk-reduction|"Men Making a Difference HIV/STD Risk Reduction Intervention was designed to reduce sexual risk behaviors that increase risk of HIV and other sexually transmitted diseases.~Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, the intervention consists of 6 75-minute modules designed to increase beliefs that support condom use; skill and self-efficacy to use condoms; and HIV/STD risk-reduction knowledge. Two modules are implemented in each of 3 weekly sessions. It is highly structured and implemented in small groups of 9 to 15 men led by a male, isiXhosa-speaking facilitators using standardized intervention manuals. It includes interactive exercises, games, brainstorming, role-playing, take-home assignments, group discussions, and videos, produced specifically for the interventions, shot in authentic township settings, including a shebeen (i.e., an informal alcohol outlet)."
219909|NCT01490359|O2|Outcome|Health Promotion Control|"Health Promotion Intervention was designed to increase physical activity, healthful diet, and other behaviors to reduce risk of noncommunicable diseases, including diabetes, hypertension, and cancers.~Health Promotion Control: The health-promotion intervention was designed to control for non-specific features including group interaction and special attention. It was structurally similar to the HIV/STD risk-reduction intervention in that it contained activities similar to the HIV/STD risk-reduction intervention but focused on behaviors linked to the risk of heart disease, hypertension, stroke, diabetes, and certain cancers-leading causes of morbidity and mortality among South Africans. It also consisted of 6 75-minute modules implemented 2 modules per week during 3 weekly sessions led by isiXhosa speaking male facilitators. It was designed to increase fruit and vegetable consumption and physical activity and decrease excessive alcohol consumption."
219910|NCT01490359|O1|Outcome|HIV/STD Risk-reduction|"Men Making a Difference HIV/STD Risk Reduction Intervention was designed to reduce sexual risk behaviors that increase risk of HIV and other sexually transmitted diseases.~Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, the intervention consists of 6 75-minute modules designed to increase beliefs that support condom use; skill and self-efficacy to use condoms; and HIV/STD risk-reduction knowledge. Two modules are implemented in each of 3 weekly sessions. It is highly structured and implemented in small groups of 9 to 15 men led by a male, isiXhosa-speaking facilitators using standardized intervention manuals. It includes interactive exercises, games, brainstorming, role-playing, take-home assignments, group discussions, and videos, produced specifically for the interventions, shot in authentic township settings, including a shebeen (i.e., an informal alcohol outlet)."
219911|NCT01490359|O2|Outcome|Health Promotion Control|"Health Promotion Intervention was designed to increase physical activity, healthful diet, and other behaviors to reduce risk of noncommunicable diseases, including diabetes, hypertension, and cancers.~Health Promotion Control: The health-promotion intervention was designed to control for non-specific features including group interaction and special attention. It was structurally similar to the HIV/STD risk-reduction intervention in that it contained activities similar to the HIV/STD risk-reduction intervention but focused on behaviors linked to the risk of heart disease, hypertension, stroke, diabetes, and certain cancers-leading causes of morbidity and mortality among South Africans. It also consisted of 6 75-minute modules implemented 2 modules per week during 3 weekly sessions led by isiXhosa speaking male facilitators. It was designed to increase fruit and vegetable consumption and physical activity and decrease excessive alcohol consumption."
219928|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219929|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219912|NCT01490359|O1|Outcome|HIV/STD Risk-reduction|"Men Making a Difference HIV/STD Risk Reduction Intervention was designed to reduce sexual risk behaviors that increase risk of HIV and other sexually transmitted diseases.~Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, it consists of 6 75-minute modules designed to increase beliefs that support condom use; skill and self-efficacy to use condoms; and HIV/STD risk-reduction knowledge. Two modules are implemented in each of 3 weekly sessions. It is highly structured and implemented in small groups of 9 to 15 men led by a male, isiXhosa-speaking facilitators using standardized intervention manuals. It includes interactive exercises, games, brainstorming, role-playing, take-home assignments, group discussions, and videos, produced specifically for the interventions, shot in authentic township settings, including a shebeen (i.e., an informal alcohol outlet)."
219913|NCT01490359|E2|Reported Event|Health Promotion Control|"Health Promotion Intervention was designed to increase physical activity, healthful diet, and other behaviors to reduce risk of noncommunicable diseases, including diabetes, hypertension, and cancers.~Health Promotion Control: The health-promotion intervention was designed to control for non-specific features including group interaction and special attention. It was structurally similar to the HIV/STD risk-reduction intervention in that it contained activities similar to the HIV/STD risk-reduction intervention but focused on behaviors linked to the risk of heart disease, hypertension, stroke, diabetes, and certain cancers-leading causes of morbidity and mortality among South Africans. It also consisted of 6 75-minute modules implemented 2 modules per week during 3 weekly sessions led by isiXhosa speaking male facilitators. It was designed to increase fruit and vegetable consumption and physical activity and decrease excessive alcohol consumption."
219914|NCT01490359|E1|Reported Event|HIV/STD Risk-reduction|"Men Making a Difference HIV/STD Risk Reduction Intervention was designed to reduce sexual risk behaviors that increase risk of HIV and other sexually transmitted diseases.~Men Making a Difference HIV/STD Risk Reduction Intervention: Developed based on social cognitive theory and extensive formative research, it consists of 6 75-minute modules designed to increase beliefs that support condom use; skill and self-efficacy to use condoms; and HIV/STD risk-reduction knowledge. Two modules are implemented in each of 3 weekly sessions. It is highly structured and implemented in small groups of 9 to 15 men led by a male, isiXhosa-speaking facilitators using standardized intervention manuals. It includes interactive exercises, games, brainstorming, role-playing, take-home assignments, group discussions, and videos, produced specifically for the interventions, shot in authentic township settings, including a shebeen (i.e., an informal alcohol outlet)."
219915|NCT01490294|B5|Baseline|Total|Total of all reporting groups
219916|NCT01490294|B4|Baseline|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219917|NCT01490294|B3|Baseline|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219918|NCT01490294|B2|Baseline|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219919|NCT01490294|B1|Baseline|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg body weight (BW) (0.01mL/kg) for stress magnetic resonance imaging (MRI) via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219920|NCT01490294|P4|Participant Flow|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219921|NCT01490294|P3|Participant Flow|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219922|NCT01490294|P2|Participant Flow|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219923|NCT01490294|P1|Participant Flow|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg body weight (BW) (0.01mL/kg) for stress magnetic resonance imaging (MRI) via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219924|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219925|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219926|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220197|NCT01490125|O2|Outcome|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
219930|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219931|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219932|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219933|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219934|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219935|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219936|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219937|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219938|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219939|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219940|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219941|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219942|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219943|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219944|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219945|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219946|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219947|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219948|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219949|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
242301|NCT01421667|O3|Outcome|CD30+ DLBCL, BV|
219950|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219951|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219952|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219953|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219954|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219955|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219956|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219957|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219958|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219959|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219960|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219961|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219962|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219963|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219964|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219965|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219966|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219967|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219968|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219969|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
242302|NCT01421667|O2|Outcome|CD30+ Other B-Cell NHL, BV|
219970|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219971|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219972|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219973|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219974|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219975|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219976|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219977|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219978|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219979|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219980|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219981|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219982|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219983|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219984|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219985|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219986|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219987|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219988|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219989|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
242303|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
219990|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219991|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219992|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219993|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219994|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219995|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219996|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219997|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219998|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
219999|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220000|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220001|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220002|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220003|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220004|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220005|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220006|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220007|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220008|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220009|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
242304|NCT01421667|O4|Outcome|CD30u DLBCL, BV|
220010|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220011|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220012|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220013|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220014|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220015|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220016|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220017|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220018|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220019|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220020|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220021|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220022|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220023|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220024|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220025|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220026|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220027|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220028|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220029|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
242305|NCT01421667|O3|Outcome|CD30+ DLBCL, BV|
220030|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220031|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220032|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220033|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220034|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220035|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220036|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220037|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220038|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220039|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220040|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220041|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220042|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220043|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220044|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220045|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220046|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220047|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220048|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220049|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
242306|NCT01421667|O2|Outcome|CD30+ Other B-Cell NHL, BV|
220050|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220051|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220052|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220053|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220054|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220055|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220056|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220057|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220058|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220059|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220060|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220061|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220062|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220063|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220064|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220065|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220066|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220067|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220068|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220069|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
242307|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
220070|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220071|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220072|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220073|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220074|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220075|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220076|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220077|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220078|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220079|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220080|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220081|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220082|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220083|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220084|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220085|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220086|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220087|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220088|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220089|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
242308|NCT01421667|O4|Outcome|CD30u DLBCL, BV|
220090|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220091|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220092|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220093|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220094|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220095|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220096|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220097|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220098|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220099|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220100|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220101|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220102|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220103|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220104|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220105|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220106|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220107|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220108|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220109|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
242309|NCT01421667|O3|Outcome|CD30+ DLBCL, BV|
220110|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220111|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220112|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220113|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220114|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220115|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220116|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220117|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220118|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220119|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220120|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220121|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220122|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220123|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220124|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220125|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220126|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220127|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220128|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220129|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
242310|NCT01421667|O2|Outcome|CD30+ Other B-Cell NHL, BV|
220130|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220131|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220132|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220133|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220134|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220135|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220136|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220137|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220138|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220139|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220140|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220141|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220142|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220143|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220144|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220145|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220146|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220147|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220148|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220149|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
242311|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
220150|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220151|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220152|NCT01490294|E4|Reported Event|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220153|NCT01490294|E3|Reported Event|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220154|NCT01490294|E2|Reported Event|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220155|NCT01490294|E1|Reported Event|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
220156|NCT01490190|B1|Baseline|NuvaRing: Safety Population|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.
220157|NCT01490190|P1|Participant Flow|NuvaRing: Safety Population|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.
220158|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
220159|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
220160|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
220161|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
220162|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
220163|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
220164|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
220165|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
220166|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
220167|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
220168|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
220169|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
220170|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
220171|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
220172|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
220173|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
220174|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
220175|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
220176|NCT01490190|E1|Reported Event|NuvaRing: Safety Population|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.
220198|NCT01490125|O1|Outcome|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
220199|NCT01490125|O3|Outcome|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
220859|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
220177|NCT01490151|B1|Baseline|TTR Controller|"The intervention will consist of using the TTR controller (Medtronic) for post-prandial glucose control following high and low glycemic meals~TTR controller (Medtronic): Subjects will arrive in the morning and the TTR controller (Medtronic) will be initialized, and then they will give their usual premeal insulin bolus for breakfast. At lunch, they will either have a low glycemic index meal or a high glycemic index meal and the meal bolus will be omitted. The device will be turned off before dinner, they will have their usual insulin bolus for dinner, eat dinner, and then be discharged to home. On another admission, they will receive an insulin dose before lunch which will be 120% of their usual insulin bolus."
220178|NCT01490151|P1|Participant Flow|TTR Controller|"The intervention will consist of using the Treat to Range (TTR) controller (Medtronic) for post-prandial glucose control following high and low glycemic meals~TTR controller (Medtronic): Subjects will arrive in the morning and the TTR controller (Medtronic) will be initialized, and then they will give their usual premeal insulin bolus for breakfast. At lunch, they will either have a low glycemic index meal or a high glycemic index meal and the meal bolus will be omitted. The device will be turned off before dinner, they will have their usual insulin bolus for dinner, eat dinner, and then be discharged to home. On another admission, they will receive an insulin dose before lunch which will be 120% of their usual insulin bolus."
220179|NCT01490151|O3|Outcome|Cohort B - Overbolus Meal|"The intervention will consist of using the TTR controller (Medtronic) for post-prandial glucose control following high and low glycemic meals~TTR controller (Medtronic): Subjects will arrive in the morning and the TTR controller (Medtronic) will be initialized, and then they will give their usual premeal insulin bolus for breakfast. At lunch, they will receive an insulin dose which will be 120% of their usual insulin bolus. The device will be turned off before dinner, they will have their usual insulin bolus for dinner, eat dinner, and then be discharged to home."
220180|NCT01490151|O2|Outcome|Cohort A2 - Missed Bolus Meal|"The intervention will consist of using the TTR controller (Medtronic) for post-prandial glucose control following high and low glycemic meals~TTR controller (Medtronic): Subjects will arrive in the morning and the TTR controller (Medtronic) will be initialized, and then they will give their usual premeal insulin bolus for breakfast. At lunch, they will have a high glycemic index meal and the meal bolus will be omitted. The device will be turned off before dinner, they will have their usual insulin bolus for dinner, eat dinner, and then be discharged to home."
220181|NCT01490151|O1|Outcome|Cohort A1 - Missed Bolus Meal|"The intervention will consist of using the TTR controller (Medtronic) for post-prandial glucose control following high and low glycemic meals~TTR controller (Medtronic): Subjects will arrive in the morning and the TTR controller (Medtronic) will be initialized, and then they will give their usual premeal insulin bolus for breakfast. At lunch, they will either have a low glycemic index meal (Cohort A1) or a high glycemic index meal (Cohort A2) and the meal bolus will be omitted. The device will be turned off before dinner, they will have their usual insulin bolus for dinner, eat dinner, and then be discharged to home. On another admission, they will receive an insulin dose before lunch which will be 120% of their usual insulin bolus (Cohort B)."
220182|NCT01490151|E1|Reported Event|TTR Controller|"The intervention will consist of using the TTR controller (Medtronic) for post-prandial glucose control following high and low glycemic meals~TTR controller (Medtronic): Subjects will arrive in the morning and the TTR controller (Medtronic) will be initialized, and then they will give their usual premeal insulin bolus for breakfast. At lunch, they will either have a low glycemic index meal or a high glycemic index meal and the meal bolus will be omitted. The device will be turned off before dinner, they will have their usual insulin bolus for dinner, eat dinner, and then be discharged to home. On another admission, they will receive an insulin dose before lunch which will be 120% of their usual insulin bolus."
220183|NCT01490125|B1|Baseline|All Participants|All participants who entered the study and were randomized to any of the 3 treatment combinations: QVA149 plus placebo to tiotropium; tiotropium plus placebo to QVA149 or placebo to QVA149 plus placebo to tiotropium.
220184|NCT01490125|P6|Participant Flow|Tiotropium + Placebo +QVA149|Participants were randomized to sequence tiotropium + placebo + QVA149
220185|NCT01490125|P5|Participant Flow|Tiotropium + QVA149+ Placebo|Participants were randomized to sequence tiotropium + QVA149 + placebo
220186|NCT01490125|P4|Participant Flow|Placebo+ Tiotropium + QVA149|Participants were randomized to sequence placebo + tiotropium + QVA149
220187|NCT01490125|P3|Participant Flow|Placebo + QVA149 + Tiotropium|Participants were randomized to sequence placebo + QVA149 + tiotropium
220188|NCT01490125|P2|Participant Flow|QVA149+ Tiotropium+ Placebo|Participants were randomized to sequence QVA149 + tiotropium + placebo.
220189|NCT01490125|P1|Participant Flow|QVA149+ Placebo+ Tiotropium|Participants were randomized to sequence QVA149 + placebo + tiotropium.
220190|NCT01490125|O3|Outcome|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
220191|NCT01490125|O2|Outcome|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
220192|NCT01490125|O1|Outcome|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
220193|NCT01490125|O3|Outcome|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
220194|NCT01490125|O2|Outcome|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
220195|NCT01490125|O1|Outcome|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
220196|NCT01490125|O3|Outcome|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
220238|NCT01490086|O4|Outcome|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
220201|NCT01490125|O1|Outcome|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
220202|NCT01490125|O3|Outcome|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
220203|NCT01490125|O2|Outcome|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
220204|NCT01490125|O1|Outcome|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
220205|NCT01490125|O3|Outcome|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
220206|NCT01490125|O2|Outcome|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
220207|NCT01490125|O1|Outcome|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
220208|NCT01490125|E3|Reported Event|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
220209|NCT01490125|E2|Reported Event|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
220210|NCT01490125|E1|Reported Event|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
220211|NCT01490086|B6|Baseline|Total|Total of all reporting groups
220212|NCT01490086|B5|Baseline|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
220213|NCT01490086|B4|Baseline|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
220214|NCT01490086|B3|Baseline|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
220215|NCT01490086|B2|Baseline|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
220216|NCT01490086|B1|Baseline|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
220217|NCT01490086|P5|Participant Flow|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
220218|NCT01490086|P4|Participant Flow|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
220219|NCT01490086|P3|Participant Flow|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
220220|NCT01490086|P2|Participant Flow|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
220221|NCT01490086|P1|Participant Flow|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
220222|NCT01490086|O5|Outcome|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
220223|NCT01490086|O4|Outcome|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
220224|NCT01490086|O3|Outcome|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
220225|NCT01490086|O2|Outcome|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
220226|NCT01490086|O1|Outcome|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
220227|NCT01490086|O5|Outcome|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
220228|NCT01490086|O4|Outcome|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
220229|NCT01490086|O3|Outcome|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
220230|NCT01490086|O2|Outcome|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
220231|NCT01490086|O1|Outcome|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
220232|NCT01490086|O5|Outcome|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
220233|NCT01490086|O4|Outcome|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
220234|NCT01490086|O3|Outcome|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
220235|NCT01490086|O2|Outcome|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
220236|NCT01490086|O1|Outcome|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
220237|NCT01490086|O5|Outcome|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
220601|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
220239|NCT01490086|O3|Outcome|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
220240|NCT01490086|O2|Outcome|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
220241|NCT01490086|O1|Outcome|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
220242|NCT01490086|O5|Outcome|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
220243|NCT01490086|O4|Outcome|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
220244|NCT01490086|O3|Outcome|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
220245|NCT01490086|O2|Outcome|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
220246|NCT01490086|O1|Outcome|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
220247|NCT01490086|E5|Reported Event|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
220248|NCT01490086|E4|Reported Event|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
220249|NCT01490086|E3|Reported Event|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
220250|NCT01490086|E2|Reported Event|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
220251|NCT01490086|E1|Reported Event|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
220252|NCT01490060|B3|Baseline|Total|Total of all reporting groups
220253|NCT01490060|B2|Baseline|Arm B: Two Doses, Day 1 + Day 4|Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1) or Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
220254|NCT01490060|B1|Baseline|Arm A: Single Dose, Day 1|Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1) or Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
220255|NCT01490060|P4|Participant Flow|Arm B: Two Doses, Group 2|Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) – 1,500 mg/m^2/day for a total of 6 gm/m^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
220256|NCT01490060|P3|Participant Flow|Arm B: Two Doses, Group 1|Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) – 1,500 mg/m^2/day for a total of 6 gm/m^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
220257|NCT01490060|P2|Participant Flow|Arm A: Single Dose, Group 2|Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) – 1,500 mg/m^2/day for a total of 6 gm/m^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
220258|NCT01490060|P1|Participant Flow|Arm A: Single Dose, Group 1|Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) – 1,500 mg/m^2/day for a total of 6 gm/m^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
220259|NCT01490060|O3|Outcome|Arm B: Two Doses, Day 1 + Day 4|Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1) or Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
220260|NCT01490060|O2|Outcome|Arm A: Single Dose, Day 1|Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1) or Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
220261|NCT01490060|O1|Outcome|Control Cycle (Arm A/Arm B)|Control cycle without fosaprepitant.
220860|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
220262|NCT01490060|E3|Reported Event|Arm B: Two Doses, Day 1 + Day 4|Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1) or Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
220263|NCT01490060|E2|Reported Event|Arm A: Single Dose, Day 1|Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1) or Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
220264|NCT01490060|E1|Reported Event|Control Cycle (Arm A/Arm B)|Control cycle without fosaprepitant.
220265|NCT01489956|B3|Baseline|Total|Total of all reporting groups
220266|NCT01489956|B2|Baseline|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
220267|NCT01489956|B1|Baseline|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
220268|NCT01489956|P3|Participant Flow|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
220269|NCT01489956|P2|Participant Flow|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
220270|NCT01489956|P1|Participant Flow|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
220271|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
220272|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
220273|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
220274|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
220275|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
220276|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
220277|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
220278|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
220279|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
220280|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
220281|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
220616|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
220282|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
220283|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
220284|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
220285|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
220286|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
220287|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
220288|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
220289|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
220290|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
220291|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
220292|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
220293|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
220294|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
220295|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
220296|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
220297|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
220298|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
220299|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
220300|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
220301|NCT01489956|E3|Reported Event|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
220302|NCT01489956|E2|Reported Event|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
220303|NCT01489956|E1|Reported Event|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
220304|NCT01489891|B3|Baseline|Total|Total of all reporting groups
220305|NCT01489891|B2|Baseline|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.~Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
220306|NCT01489891|B1|Baseline|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD~Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
220307|NCT01489891|P2|Participant Flow|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.~Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
220308|NCT01489891|P1|Participant Flow|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated esophagogastroduodenoscopy (EGD)~Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
220309|NCT01489891|O2|Outcome|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.~Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
220310|NCT01489891|O1|Outcome|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD~Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
220311|NCT01489891|O2|Outcome|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.~Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
220312|NCT01489891|O1|Outcome|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD~Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
220313|NCT01489891|O2|Outcome|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.~Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
220314|NCT01489891|O1|Outcome|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD~Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
220315|NCT01489891|O2|Outcome|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.~Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
220316|NCT01489891|O1|Outcome|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD~Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
220317|NCT01489891|E2|Reported Event|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.~Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
220318|NCT01489891|E1|Reported Event|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD~Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
220319|NCT01489826|B10|Baseline|Total|Total of all reporting groups
220320|NCT01489826|B9|Baseline|Dexanabinol Expansion Phase|Open label, expansion phase to assess pharmacodynamics of dexanabinol in patients with advanced tumours at the MTD/MAD (30 mg/kg)
220321|NCT01489826|B8|Baseline|Dexanabinol Dose Escalation - Cohort 8|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
220322|NCT01489826|B7|Baseline|Dexanabinol Dose Escalation - Cohort 7|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
220323|NCT01489826|B6|Baseline|Dexanabinol Dose Escalation - Cohort 6|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
220324|NCT01489826|B5|Baseline|Dexanabinol Dose Escalation - Cohort 5|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
220325|NCT01489826|B4|Baseline|Dexanabinol Dose Escalation - Cohort 4|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
220326|NCT01489826|B3|Baseline|Dexanabinol Dose Escalation - Cohort 3|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
220327|NCT01489826|B2|Baseline|Dexanabinol Dose Escalation - Cohort 2|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
220328|NCT01489826|B1|Baseline|Dexanabinol Dose Escalation - Cohort 1|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
220329|NCT01489826|P9|Participant Flow|Dexanabinol Expansion Phase|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220330|NCT01489826|P8|Participant Flow|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220331|NCT01489826|P7|Participant Flow|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220332|NCT01489826|P6|Participant Flow|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220333|NCT01489826|P5|Participant Flow|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220334|NCT01489826|P4|Participant Flow|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220335|NCT01489826|P3|Participant Flow|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220336|NCT01489826|P2|Participant Flow|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220337|NCT01489826|P1|Participant Flow|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220338|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220339|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220340|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220341|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220342|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220343|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220344|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220345|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220346|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220347|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220348|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220349|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220350|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220351|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220352|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220353|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220354|NCT01489826|O7|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220355|NCT01489826|O6|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220356|NCT01489826|O5|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220357|NCT01489826|O4|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220358|NCT01489826|O3|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220359|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220360|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220361|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220362|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220363|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220364|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220365|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220366|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220367|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220368|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220369|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220370|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220371|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220372|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220373|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220374|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220375|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220376|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220377|NCT01489826|O6|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220378|NCT01489826|O5|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220379|NCT01489826|O4|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220380|NCT01489826|O3|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220381|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220382|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220383|NCT01489826|O9|Outcome|Dexanabinol Expansion Phase|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220384|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220385|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220386|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220387|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220388|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220389|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220390|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220391|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220392|NCT01489826|O9|Outcome|Dexanabinol Expansion Phase|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220393|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220394|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220395|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220396|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220397|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220398|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220399|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220400|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220401|NCT01489826|O7|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220402|NCT01489826|O6|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220403|NCT01489826|O5|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220404|NCT01489826|O4|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220405|NCT01489826|O3|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220406|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220407|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220408|NCT01489826|O7|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220409|NCT01489826|O6|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220410|NCT01489826|O5|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220411|NCT01489826|O4|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220412|NCT01489826|O3|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220413|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220414|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220415|NCT01489826|O9|Outcome|Dexanabinol Expansion Phase|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220416|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220417|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220418|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220419|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220420|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220421|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220422|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220423|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220424|NCT01489826|E9|Reported Event|Dexanabinol Expansion Phase|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220425|NCT01489826|E8|Reported Event|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220426|NCT01489826|E7|Reported Event|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220427|NCT01489826|E6|Reported Event|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220428|NCT01489826|E5|Reported Event|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220429|NCT01489826|E4|Reported Event|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220430|NCT01489826|E3|Reported Event|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220431|NCT01489826|E2|Reported Event|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220432|NCT01489826|E1|Reported Event|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
220433|NCT01489670|B1|Baseline|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
220434|NCT01489670|P1|Participant Flow|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
220435|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
220436|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
220437|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
220438|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
220439|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
220440|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
220441|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
220442|NCT01489670|E1|Reported Event|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
220443|NCT01489527|B3|Baseline|Total|Total of all reporting groups
220444|NCT01489527|B2|Baseline|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
220445|NCT01489527|B1|Baseline|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
220446|NCT01489527|P2|Participant Flow|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
220447|NCT01489527|P1|Participant Flow|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
220448|NCT01489527|O2|Outcome|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
220449|NCT01489527|O1|Outcome|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
220450|NCT01489527|O2|Outcome|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
220451|NCT01489527|O1|Outcome|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
220452|NCT01489527|O2|Outcome|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
220453|NCT01489527|O1|Outcome|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
220454|NCT01489527|O2|Outcome|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
220455|NCT01489527|O1|Outcome|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
220456|NCT01489527|O2|Outcome|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
220457|NCT01489527|O1|Outcome|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
220458|NCT01489527|E2|Reported Event|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
220459|NCT01489527|E1|Reported Event|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
220460|NCT01489358|B4|Baseline|Total|Total of all reporting groups
220461|NCT01489358|B3|Baseline|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220462|NCT01489358|B2|Baseline|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220463|NCT01489358|B1|Baseline|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220464|NCT01489358|P3|Participant Flow|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220465|NCT01489358|P2|Participant Flow|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220647|NCT01488877|P2|Participant Flow|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
220466|NCT01489358|P1|Participant Flow|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220467|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220468|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220469|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220470|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220471|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220472|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220473|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220474|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220475|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220476|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220477|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220478|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220479|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220480|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220481|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220482|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220483|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220484|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220485|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220486|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220487|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220488|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220489|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220490|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220491|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220492|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220493|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220494|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220495|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220496|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220497|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220498|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220499|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220500|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220737|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
220501|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220502|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220503|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220504|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220505|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220506|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220507|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220508|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220509|NCT01489358|E3|Reported Event|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220510|NCT01489358|E2|Reported Event|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220511|NCT01489358|E1|Reported Event|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
220512|NCT01489254|B4|Baseline|Total|Total of all reporting groups
220513|NCT01489254|B3|Baseline|Placebo|Placebo (daily) for 9 months
220514|NCT01489254|B2|Baseline|Copaxone 20 mg|Glatiramer Acetate (Copaxone) 20 mg daily for 9 months
220515|NCT01489254|B1|Baseline|Glatiramer 20 mg|Glatiramer Acetate (GTR) 20 mg daily for 9 months
220516|NCT01489254|P4|Participant Flow|Extension Glatiramer 20 mg|Glatiramer acetate (GTR) 20 mg daily for 15 months, open-label extension
220517|NCT01489254|P3|Participant Flow|Placebo|Placebo (daily) for 9 months
220518|NCT01489254|P2|Participant Flow|Copaxone 20 mg|Glatiramer Acetate (Copaxone) 20 mg daily for 9 months
220519|NCT01489254|P1|Participant Flow|Glatiramer 20 mg|Glatiramer Acetate (GTR) 20 mg daily for 9 months
220520|NCT01489254|O3|Outcome|Placebo|Placebo (daily) for 9 months
220521|NCT01489254|O2|Outcome|Copaxone 20 mg|Glatiramer Acetate (Copaxone) 20 mg daily for 9 months
220522|NCT01489254|O1|Outcome|Glatiramer 20 mg|Glatiramer Acetate (GTR) 20 mg daily for 9 months
220523|NCT01489254|E4|Reported Event|Extension Glatiramer 20 mg|Glatiramer acetate (GTR) 20 mg daily for 15 months, open-label extension
220524|NCT01489254|E3|Reported Event|Placebo|Placebo (daily) for 9 months, double-blind
220525|NCT01489254|E2|Reported Event|Copaxone 20 mg|Glatiramer Acetate (Copaxone) 20 mg daily for 9 months, double-blind
220526|NCT01489254|E1|Reported Event|Glatiramer 20 mg|Glatiramer Acetate (GTR) 20 mg daily for 9 months, double-blind
220527|NCT01489189|B3|Baseline|Total|Total of all reporting groups
220528|NCT01489189|B2|Baseline|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
220529|NCT01489189|B1|Baseline|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
220530|NCT01489189|P2|Participant Flow|Prompt PRP|"Panretinal Photocoagulation (PRP). PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
220531|NCT01489189|P1|Participant Flow|Anti-VEGF+Deferred PRP|"Anti vascular endothelial growth factor (Anti-VEGF). Panretinal photocoagulation (PRP). Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
220532|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
220533|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
220534|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
220535|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
220536|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
220648|NCT01488877|P1|Participant Flow|PF-03882845 Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
220649|NCT01488877|O2|Outcome|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
220537|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
220538|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
220539|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
220540|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
220541|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
220542|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
220543|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
220544|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
220545|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
220546|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
220547|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
220548|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
220549|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
220550|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
220551|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
220552|NCT01489189|E3|Reported Event|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
220553|NCT01489189|E2|Reported Event|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
220554|NCT01489189|E1|Reported Event|Bilateral Participants|Participants with one eye enrolled in each arm of the study.
220555|NCT01488994|B3|Baseline|Total|Total of all reporting groups
220556|NCT01488994|B2|Baseline|Pediatric Participants 6 to <12 Years of Age|Pediatric participants 6 to <12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220650|NCT01488877|O1|Outcome|Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
220651|NCT01488877|O2|Outcome|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
220652|NCT01488877|O1|Outcome|Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
220557|NCT01488994|B1|Baseline|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220558|NCT01488994|P2|Participant Flow|Pediatric Participants 6 to <12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220559|NCT01488994|P1|Participant Flow|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220560|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
220561|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220562|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220563|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
220564|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220565|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220566|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
220567|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220568|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220569|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
220570|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
242312|NCT01421667|O4|Outcome|CD30u DLBCL, BV|
220571|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220572|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
220573|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220574|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220575|NCT01488994|O1|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
220576|NCT01488994|O1|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
220577|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
220578|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220579|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220580|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
220581|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220582|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220583|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
220584|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220585|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220586|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
220653|NCT01488877|O1|Outcome|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
220654|NCT01488877|O2|Outcome|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
242313|NCT01421667|O3|Outcome|CD30+ DLBCL, BV|
220587|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220588|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220589|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
220590|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220591|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220592|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
220593|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220594|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220595|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
220596|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220597|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220598|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
220599|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220600|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220845|NCT01488071|P2|Participant Flow|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
220602|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220603|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220604|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
220605|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220606|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220607|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
220608|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220609|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220610|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
220611|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220612|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220613|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
220614|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220615|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220846|NCT01488071|P1|Participant Flow|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
220617|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220618|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220619|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
220620|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220621|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220622|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
220623|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220624|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220625|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
220626|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220627|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220628|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
220629|NCT01488994|O2|Outcome|BAX326 6 to <12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220655|NCT01488877|O1|Outcome|Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
220656|NCT01488877|O2|Outcome|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
242314|NCT01421667|O2|Outcome|CD30+ Other B-Cell NHL, BV|
220630|NCT01488994|O1|Outcome|BAX326 < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220631|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
220632|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220633|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220634|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
220635|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220636|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220637|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
220638|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220639|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220640|NCT01488994|O1|Outcome|Overall Study Arm|No participants
220641|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
220642|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220643|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
220644|NCT01488994|E1|Reported Event|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
220645|NCT01488877|B1|Baseline|Entire Study Population|All participants who were enrolled in this study.
220646|NCT01488877|P3|Participant Flow|Spironolactone Placebo|Similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
220657|NCT01488877|O1|Outcome|Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
220658|NCT01488877|O2|Outcome|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
220659|NCT01488877|O1|Outcome|Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
220660|NCT01488877|E2|Reported Event|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
220661|NCT01488877|E1|Reported Event|Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
220662|NCT01488708|B3|Baseline|Total|Total of all reporting groups
220663|NCT01488708|B2|Baseline|LY2127399 Q4W|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
220664|NCT01488708|B1|Baseline|LY 2127399 Q2W|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
220665|NCT01488708|P2|Participant Flow|LY2127399 Q4W|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
220666|NCT01488708|P1|Participant Flow|LY 2127399 Q2W|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
220667|NCT01488708|O2|Outcome|LY2127399 Q4W|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
220668|NCT01488708|O1|Outcome|LY 2127399 Q2W|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
220669|NCT01488708|O2|Outcome|LY2127399 Q4W|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
220697|NCT01488578|O2|Outcome|Without Urinary Urgency|Participants without urinary urgency who took tolterodine according to Japanese Package Insert.
220670|NCT01488708|O1|Outcome|LY 2127399 Q2W|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
220671|NCT01488708|O2|Outcome|LY2127399 Q4W|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
220672|NCT01488708|O1|Outcome|LY 2127399 Q2W|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
220673|NCT01488708|O2|Outcome|LY2127399 Q4W|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
220674|NCT01488708|O1|Outcome|LY 2127399 Q2W|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
220675|NCT01488708|O2|Outcome|LY2127399 Q4W|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
220676|NCT01488708|O1|Outcome|LY 2127399 Q2W|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
220677|NCT01488708|O2|Outcome|LY2127399 Q4W|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
220698|NCT01488578|O1|Outcome|With Urinary Urgency|Participants with urinary urgency who took tolterodine according to Japanese Package Insert.
220699|NCT01488578|O3|Outcome|Severe|Participants with severe OAB who took tolterodine according to Japanese Package Insert.
220678|NCT01488708|O1|Outcome|LY 2127399 Q2W|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
220679|NCT01488708|O2|Outcome|LY2127399 Q4W|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
220680|NCT01488708|O1|Outcome|LY 2127399 Q2W|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
220681|NCT01488708|E4|Reported Event|LY2127399 Q4W Follow Up|If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. Follow up.
220682|NCT01488708|E3|Reported Event|LY 2127399 Q2W Follow Up|If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. Follow up.
220683|NCT01488708|E2|Reported Event|LY2127399 Q4W Treatment|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
220684|NCT01488708|E1|Reported Event|LY 2127399 Q2W Treatment|"If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks.~LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.~Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment."
220685|NCT01488578|B1|Baseline|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
220686|NCT01488578|P1|Participant Flow|Tolterodine Tartrate|Participants taking Tolterodine tartrate.
220687|NCT01488578|O1|Outcome|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
220688|NCT01488578|O2|Outcome|Without Previous Treatment|Participants without previous treatment of OAB who took tolterodine according to Japanese Package Insert.
220689|NCT01488578|O1|Outcome|With Previous Treatment|Participants with previous treatment of OAB who took tolterodine according to Japanese Package Insert.
220690|NCT01488578|O3|Outcome|>= 5 Episodes|Participants with >= 5 urinary incontinence episodes per day who took tolterodine according to Japanese Package Insert.
220691|NCT01488578|O2|Outcome|3 to 4 Episodes|Participants with 3 or 4 urinary incontinence episodes per day who took tolterodine according to Japanese Package Insert.
220692|NCT01488578|O1|Outcome|1 to 2 Episodes|Participants with 1 or 2 urinary incontinence episodes per day who took tolterodine according to Japanese Package Insert.
220693|NCT01488578|O4|Outcome|>= 3 Urinations|Participants with >= 3 times urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
220694|NCT01488578|O3|Outcome|2 Urinations|Participants with 2 times urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
220695|NCT01488578|O2|Outcome|1 Urination|Participants with 1 time urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
220696|NCT01488578|O1|Outcome|No Urination|Participants with no urination who took tolterodine according to Japanese Package Insert.
220700|NCT01488578|O2|Outcome|Moderate|Participants with moderate OAB who took tolterodine according to Japanese Package Insert.
220703|NCT01488578|O2|Outcome|Without BPH|Participants without complication of benign prostatic hypertrophy who took tolterodine according to Japanese Package Insert.
220704|NCT01488578|O1|Outcome|With BPH|Participants with complication of benign prostatic hypertrophy who took tolterodine according to Japanese Package Insert.
220705|NCT01488578|O2|Outcome|>=65 Years|Participants with >= 65 years who took tolterodine according to Japanese Package Insert.
220706|NCT01488578|O1|Outcome|<65 Years|Participants with < 65 years who took tolterodine according to Japanese Package Insert.
220707|NCT01488578|O2|Outcome|Without Complications|Participants without complications who took tolterodine according to Japanese Package Insert.
220708|NCT01488578|O1|Outcome|With Complications|Participants with complications who took tolterodine according to Japanese Package Insert.
220709|NCT01488578|O2|Outcome|Female|Female participants who took tolterodine according to Japanese Package Insert.
220710|NCT01488578|O1|Outcome|Male|Male participants who took tolterodine according to Japanese Package Insert.
220711|NCT01488578|O2|Outcome|Without Non-drug Therapies|Participants without non-drug therapies who took tolterodine according to Japanese Package Insert.
220712|NCT01488578|O1|Outcome|With Non-drug Therapies|Participants with non-drug therapies who took tolterodine according to Japanese Package Insert.
220713|NCT01488578|O1|Outcome|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
220714|NCT01488578|O1|Outcome|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
220715|NCT01488578|O2|Outcome|Without Concomitant Drugs|Participants without concomitant drugs who took tolterodine according to Japanese Package Insert.
220716|NCT01488578|O1|Outcome|With Concomitant Drugs|Participants with concomitant drugs who took tolterodine according to Japanese Package Insert.
220717|NCT01488578|O1|Outcome|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
220718|NCT01488578|E1|Reported Event|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
220719|NCT01488487|B1|Baseline|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.~Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.~Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
220720|NCT01488487|P1|Participant Flow|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.~Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.~Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
220721|NCT01488487|O1|Outcome|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.~Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.~Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
220722|NCT01488487|O1|Outcome|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.~Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.~Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
220723|NCT01488487|O1|Outcome|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.~Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.~Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
220724|NCT01488487|O1|Outcome|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.~Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.~Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
220725|NCT01488487|E1|Reported Event|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.~Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.~Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
220726|NCT01488448|B3|Baseline|Total|Total of all reporting groups
220727|NCT01488448|B2|Baseline|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
220728|NCT01488448|B1|Baseline|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
220729|NCT01488448|P2|Participant Flow|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
220730|NCT01488448|P1|Participant Flow|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
220731|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
220732|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
220733|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
220734|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
220735|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
220738|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
220739|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
220740|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
220741|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
220742|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
220743|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
220744|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
220745|NCT01488448|O2|Outcome|Nebulized Normal Saline|"4 mL nebulized 0.9% sodium chloride every 4 hours until discharge~0.9% sodium chloride: 4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge"
220746|NCT01488448|O1|Outcome|Nebulized Hypertonic Saline|"4mL nebulized 3% sodium chloride every 4 hours until discharge~3% sodium chloride: 4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge"
220747|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
220748|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
220749|NCT01488448|E2|Reported Event|Normal Saline|4mL nebulized 0.9% sodium chloride every 4 hours until discharge
220750|NCT01488448|E1|Reported Event|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
220751|NCT01488409|B3|Baseline|Total|Total of all reporting groups
220752|NCT01488409|B2|Baseline|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
220753|NCT01488409|B1|Baseline|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
220754|NCT01488409|P2|Participant Flow|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
220755|NCT01488409|P1|Participant Flow|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
220756|NCT01488409|O2|Outcome|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
220757|NCT01488409|O1|Outcome|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
220758|NCT01488409|O2|Outcome|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
220759|NCT01488409|O1|Outcome|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
220760|NCT01488409|O2|Outcome|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
220761|NCT01488409|O1|Outcome|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
220762|NCT01488409|O2|Outcome|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
220763|NCT01488409|O1|Outcome|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
220764|NCT01488409|O2|Outcome|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
220765|NCT01488409|O1|Outcome|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
220766|NCT01488409|E2|Reported Event|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
220767|NCT01488409|E1|Reported Event|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
220768|NCT01488370|B4|Baseline|Total|Total of all reporting groups
220769|NCT01488370|B3|Baseline|Standard Laryngoscope|"A device for endotracheal intubation~Endotracheal intubation: Endotracheal intubation"
220770|NCT01488370|B2|Baseline|Storz|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
220771|NCT01488370|B1|Baseline|Glidescope|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
220772|NCT01488370|P3|Participant Flow|Standard Laryngoscope|"A device for endotracheal intubation~Endotracheal intubation: Endotracheal intubation"
220773|NCT01488370|P2|Participant Flow|Storz|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
220774|NCT01488370|P1|Participant Flow|Glidescope|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
220775|NCT01488370|O3|Outcome|Standard Laryngoscope|"A device for endotracheal intubation~Endotracheal intubation: Endotracheal intubation"
220776|NCT01488370|O2|Outcome|Storz|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
220777|NCT01488370|O1|Outcome|Glidescope|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
220778|NCT01488370|O3|Outcome|Standard Laryngoscope|"A device for endotracheal intubation~Endotracheal intubation: Endotracheal intubation"
220779|NCT01488370|O2|Outcome|Storz|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
220780|NCT01488370|O1|Outcome|Glidescope|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
220781|NCT01488370|O3|Outcome|Standard Laryngoscope|"A device for endotracheal intubation~Endotracheal intubation: Endotracheal intubation"
220782|NCT01488370|O2|Outcome|Storz|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
220783|NCT01488370|O1|Outcome|Glidescope|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
220784|NCT01488370|O3|Outcome|Standard Laryngoscope|"A device for endotracheal intubation~Endotracheal intubation: Endotracheal intubation"
220785|NCT01488370|O2|Outcome|Storz|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
220786|NCT01488370|O1|Outcome|Glidescope|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
220787|NCT01488370|O3|Outcome|Standard Laryngoscope|"A device for endotracheal intubation~Endotracheal intubation: Endotracheal intubation"
220788|NCT01488370|O2|Outcome|Storz|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
220789|NCT01488370|O1|Outcome|Glidescope|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
242315|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
220790|NCT01488370|E3|Reported Event|Standard Laryngoscope|"A device for endotracheal intubation~Endotracheal intubation: Endotracheal intubation"
220791|NCT01488370|E2|Reported Event|Storz|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
220792|NCT01488370|E1|Reported Event|Glidescope|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
220793|NCT01488318|B1|Baseline|CETUXIMAB + DASATINIB|
220794|NCT01488318|P1|Participant Flow|CETUXIMAB + DASATINIB|Cetuximab dosed at 250 mg/m^2/week and Dasatinib dosed at 150 mg daily
220795|NCT01488318|O1|Outcome|CETUXIMAB + DASATINIB|
220796|NCT01488318|O1|Outcome|CETUXIMAB + DASATINIB|
220797|NCT01488318|O1|Outcome|CETUXIMAB + DASATINIB|
220798|NCT01488318|O1|Outcome|CETUXIMAB + DASATINIB|
220799|NCT01488318|E1|Reported Event|CETUXIMAB + DASATINIB|Cetuximab dosed at 250 mg/m^2/week and Dasatinib dosed at 150 mg daily
220800|NCT01488279|B3|Baseline|Total|Total of all reporting groups
220801|NCT01488279|B2|Baseline|Placebo, Then Sitagliptin|This arm involves randomization to dexamethasone 2.5 mg orally + placebo x 7 days followed by MTT and IVGTT on subsequent days. There was a 4-6 weeks washout, then subjects crossed over to dex + sitagliptin.
220802|NCT01488279|B1|Baseline|Sitagliptin, Then Placebo|This arm involves randomization to dexamethasone 2.5 mg + sitagliptin 100 mg daily x 7 days followed by MTT and IVGTT on subsequent days. There was a 4-6 week washout, then subjects crossed over to dex + placebo.
220803|NCT01488279|P2|Participant Flow|Placebo, Then Sitaglipton|Dex 2.5 mg + placebo (7 days), washout (4-6 weeks), Sitalgiptin + placebo ( 7 days)
220804|NCT01488279|P1|Participant Flow|Sitagliptin, Then Placebo|Dex 2.5 mg + sitagliptin 100 mg daily (7 days), washout (4-6 weeks), dex + placebo (7 days)
220805|NCT01488279|O2|Outcome|Placebo|Participants received dex 2.5 mg + placebo daily x 7 days.
220806|NCT01488279|O1|Outcome|Sitagliptin|Participants received dex 2.5 mg + sitagliptin 100 mg daily x 7 days.
220807|NCT01488279|O2|Outcome|Placebo|This arm involves randomization to dexamethasone 2.5 mg + placebo daily x 7 days followed by MTT and IVGTT on subsequent days.
220808|NCT01488279|O1|Outcome|Sitagliptin|This arm involves randomization to dexamethasone 2.5 mg + sitagliptin 100 mg daily x 7 days followed by MTT and IVGTT on subsequent days.
220809|NCT01488279|O2|Outcome|Placebo|This arm involves randomization to dexamethasone 2.5 mg + placebo daily x 7 days followed by MTT and IVGTT on subsequent days.
220810|NCT01488279|O1|Outcome|Sitagliptin|This arm involves randomization to dexamethasone 2.5 mg + sitagliptin 100 mg daily x 7 days followed by MTT and IVGTT on subsequent days.
220811|NCT01488279|O2|Outcome|Placebo|This arm involves randomization to dexamethasone 2.5 mg + placebo daily x 7 days followed by MTT and IVGTT on subsequent days.
220812|NCT01488279|O1|Outcome|Sitagliptin|This arm involves randomization to dexamethasone 2.5 mg + sitagliptin 100 mg daily x 7 days followed by MTT and IVGTT on subsequent days.
220813|NCT01488279|O2|Outcome|Placebo|This arm involves randomization to dexamethasone 2.5 mg orally + placebo x 7 days followed by MTT and IVGTT on subsequent days.
220814|NCT01488279|O1|Outcome|Sitagliptin|This arm involves randomization to dexamethasone 2.5 mg + sitagliptin 100 mg daily x 7 days followed by MTT and IVGTT on subsequent days.
220815|NCT01488279|E2|Reported Event|Placebo, Then Sitagliptin|"This arm involves randomization to dexamethasone 2.5 mg orally + placebo x 7 days followed by MTT and IVGTT on subsequent days~Dexamethasone medication: 2.5 mg daily dexamethasone x 7 days"
220816|NCT01488279|E1|Reported Event|Sitagliptin, Then Placebo|"This arm involves randomization to dexamethasone 2.5 mg + sitagliptin 100 mg daily x 7 days followed by MTT and IVGTT on subsequent days.~Dexamethasone medication: 2.5 mg daily dexamethasone x 7 days"
220817|NCT01488188|B3|Baseline|Total|Total of all reporting groups
220818|NCT01488188|B2|Baseline|Influenza Vaccine-Nasal|"Nasal administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
220819|NCT01488188|B1|Baseline|Influenza Vaccine -Sublingual|"Sublingual administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
220820|NCT01488188|P2|Participant Flow|Influenza Vaccine-Nasal|"Nasal administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
220821|NCT01488188|P1|Participant Flow|Influenza Vaccine -Sublingual|"Sublingual administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
220822|NCT01488188|O2|Outcome|Influenza Vaccine-Nasal|"Nasal administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
220823|NCT01488188|O1|Outcome|Influenza Vaccine -Sublingual|"Sublingual administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
220824|NCT01488188|O2|Outcome|Influenza Vaccine-Nasal|"Nasal administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
220825|NCT01488188|O1|Outcome|Influenza Vaccine -Sublingual|"Sublingual administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
220826|NCT01488188|O2|Outcome|Influenza Vaccine-Nasal|"Nasal administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
220827|NCT01488188|O1|Outcome|Influenza Vaccine -Sublingual|"Sublingual administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
220828|NCT01488188|O2|Outcome|Influenza Vaccine-Nasal|"Nasal administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
220829|NCT01488188|O1|Outcome|Influenza Vaccine -Sublingual|"Sublingual administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
220830|NCT01488188|E2|Reported Event|Influenza Vaccine-Nasal|"Nasal administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
220831|NCT01488188|E1|Reported Event|Influenza Vaccine -Sublingual|"Sublingual administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
220847|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
220848|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
220849|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
220850|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
220851|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
220852|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
220832|NCT01488097|B1|Baseline|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
220833|NCT01488097|P1|Participant Flow|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
220834|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
220835|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
220836|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
220837|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
220838|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
220839|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
220840|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
220841|NCT01488097|E1|Reported Event|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
220842|NCT01488071|B3|Baseline|Total|Total of all reporting groups
220843|NCT01488071|B2|Baseline|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
220844|NCT01488071|B1|Baseline|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
220861|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
220862|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
220863|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
220864|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
220865|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
220866|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
220867|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
220868|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
220869|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
220870|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
220871|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
220872|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
220873|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
220874|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
220875|NCT01488071|E2|Reported Event|Agomelatine|
220876|NCT01488071|E1|Reported Event|Vortioxetine|
220877|NCT01488019|B3|Baseline|Total|Total of all reporting groups
220878|NCT01488019|B2|Baseline|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
220879|NCT01488019|B1|Baseline|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20mcg/2 mL, twice daily nebulization for 52 weeks"
220880|NCT01488019|P2|Participant Flow|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
220881|NCT01488019|P1|Participant Flow|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
220882|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
220883|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
220884|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
220885|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
220886|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
220887|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
220888|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist-Placebo: Placebo vehicle, 2mL, twice daily for 52 weeks"
220889|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist, nebulization, COPD: Perforomist, 20 mcg/2 mL, twice daily for 52 weeks"
220890|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
220891|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
220892|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
220893|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
220894|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
220895|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
220896|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
220897|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
220898|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
220899|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
220900|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
220901|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
220902|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
220903|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
220904|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
220905|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
220906|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
220907|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
220908|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
220909|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
220910|NCT01488019|E2|Reported Event|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
220911|NCT01488019|E1|Reported Event|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
220912|NCT01487954|B3|Baseline|Total|Total of all reporting groups
242316|NCT01421667|O5|Outcome|CD30+ DLBCL, BV+R|
220913|NCT01487954|B2|Baseline|Arm II: Distilled Water|"Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy~distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
220914|NCT01487954|B1|Baseline|Arm I: Alkaline Water|"Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
220915|NCT01487954|P2|Participant Flow|Arm II: Distilled Water|"Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy~distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
220916|NCT01487954|P1|Participant Flow|Arm I: Alkaline Water|"Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
220917|NCT01487954|O2|Outcome|Arm II: Distilled Water|"Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy~distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
220918|NCT01487954|O1|Outcome|Arm I: Alkaline Water|"Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
220919|NCT01487954|O2|Outcome|Arm II: Distilled Water|"Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy~distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
220920|NCT01487954|O1|Outcome|Arm I: Alkaline Water|"Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
220921|NCT01487954|E2|Reported Event|Arm II: Distilled Water|"Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy~distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
220922|NCT01487954|E1|Reported Event|Arm I: Alkaline Water|"Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
220923|NCT01487863|B3|Baseline|Total|Total of all reporting groups
220924|NCT01487863|B2|Baseline|Sequential Arm|"Subjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death, occurred.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
220925|NCT01487863|B1|Baseline|Concurrent Arm|"Subjects received sipuleucel-T concurrent with abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death, occurred.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
220926|NCT01487863|P2|Participant Flow|Sequential Arm|"Subjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
220944|NCT01487577|P1|Participant Flow|Mycophenolate Mofetil|Pharmacokinetics-based targeting of Mycophenolate mofetil
242317|NCT01421667|O4|Outcome|CD30u DLBCL, BV|
220927|NCT01487863|P1|Participant Flow|Concurrent Arm|"Subjects received sipuleucel-T with concurrent abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
220928|NCT01487863|O2|Outcome|Sequential Arm|"Subjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
220929|NCT01487863|O1|Outcome|Concurrent Arm|"Subjects received sipuleucel-T concurrent with abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
220930|NCT01487863|E2|Reported Event|Sequential Arm|"Subjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
220931|NCT01487863|E1|Reported Event|Concurrent Arm|"Subjects received sipuleucel-T concurrent with abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
220932|NCT01487668|B3|Baseline|Total|Total of all reporting groups
220933|NCT01487668|B2|Baseline|Arm 2 (Life Goals Collaborative Care)|Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.
220934|NCT01487668|B1|Baseline|Arm 1 (Usual Care)|Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.
220935|NCT01487668|P2|Participant Flow|Arm 2 (Life Goals Collaborative Care)|Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.
220936|NCT01487668|P1|Participant Flow|Arm 1 (Usual Care)|Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.
220937|NCT01487668|O2|Outcome|Arm 2 (Life Goals Collaborative Care)|Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages
220938|NCT01487668|O1|Outcome|Arm 1 (Usual Care)|Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.
220939|NCT01487668|O2|Outcome|Arm 2 (Life Goals Collaborative Care)|Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.
220940|NCT01487668|O1|Outcome|Arm 1 (Usual Care)|Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.
220941|NCT01487668|E2|Reported Event|Arm 2 (Life Goals Collaborative Care)|Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.
220942|NCT01487668|E1|Reported Event|Arm 1 (Usual Care)|Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.
220943|NCT01487577|B1|Baseline|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
220945|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
220946|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
220947|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
220948|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
220949|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
220950|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
220951|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
220952|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
220953|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
220954|NCT01487577|E1|Reported Event|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
220955|NCT01487525|B3|Baseline|Total|Total of all reporting groups
220956|NCT01487525|B2|Baseline|PBFR+|"strength training exercise with partial blood flow restriction~double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
220957|NCT01487525|B1|Baseline|PBFR-|"strength training exercise without partial blood flow restriction~double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
220958|NCT01487525|P2|Participant Flow|PBFR+|"strength training exercise with partial blood flow restriction~double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
220959|NCT01487525|P1|Participant Flow|PBFR-|"strength training exercise without partial blood flow restriction~double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
220960|NCT01487525|O2|Outcome|PBFR+|"strength training exercise with partial blood flow restriction~double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
220961|NCT01487525|O1|Outcome|PBFR-|"strength training exercise without partial blood flow restriction~double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
220962|NCT01487525|O2|Outcome|PBFR+|"strength training exercise with partial blood flow restriction~double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
220963|NCT01487525|O1|Outcome|PBFR-|"strength training exercise without partial blood flow restriction~double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
220964|NCT01487525|O2|Outcome|PBFR+|"strength training exercise with partial blood flow restriction~double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
220965|NCT01487525|O1|Outcome|PBFR-|"strength training exercise without partial blood flow restriction~double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
220966|NCT01487525|E2|Reported Event|PBFR+|"strength training exercise with partial blood flow restriction~double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
220967|NCT01487525|E1|Reported Event|PBFR-|"strength training exercise without partial blood flow restriction~double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
220968|NCT01487499|B1|Baseline|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.~Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
220969|NCT01487499|P1|Participant Flow|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.~Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
220970|NCT01487499|O1|Outcome|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.~Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
220971|NCT01487499|O1|Outcome|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.~Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
220972|NCT01487499|O1|Outcome|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.~Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
220973|NCT01487499|E1|Reported Event|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.~Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
220974|NCT01487265|B1|Baseline|Erlotinib + BKM120|BKM120, administered 80 mg by mouth (PO) daily during the first week of Cycle 1, then escalated to 100 mg PO daily. Erlotinib, administered 100 mg PO daily. Each cycle is 28 days.
220975|NCT01487265|P1|Participant Flow|Erlotinib + BKM120|BKM120, administered 80 mg by mouth (PO) daily during the first week of Cycle 1, then escalated to 100 mg PO daily. Erlotinib, administered 100 mg PO daily. Each cycle is 28 days.
220976|NCT01487265|O1|Outcome|Erlotinib + BKM120|BKM120, administered 80 mg by mouth (PO) daily during the first week of Cycle 1, then escalated to 100 mg PO daily. Erlotinib, administered 100 mg PO daily. Each cycle is 28 days.
220977|NCT01487265|O1|Outcome|Erlotinib + BKM120|BKM120, administered 80 mg by mouth (PO) daily during the first week of Cycle 1, then escalated to 100 mg PO daily. Erlotinib, administered 100 mg PO daily. Each cycle is 28 days.
220978|NCT01487265|O1|Outcome|Erlotinib + BKM120|BKM120, administered 80 mg by mouth (PO) daily during the first week of Cycle 1, then escalated to 100 mg PO daily. Erlotinib, administered 100 mg PO daily. Each cycle is 28 days.
220979|NCT01487265|O1|Outcome|Erlotinib + BKM120|BKM120, administered 80 mg by mouth (PO) daily during the first week of Cycle 1, then escalated to 100 mg PO daily. Erlotinib, administered 100 mg PO daily. Each cycle is 28 days.
220980|NCT01487265|O1|Outcome|Erlotinib + BKM120|BKM120, administered 80 mg by mouth (PO) daily during the first week of Cycle 1, then escalated to 100 mg PO daily. Erlotinib, administered 100 mg PO daily. Each cycle is 28 days.
220981|NCT01487265|E1|Reported Event|Erlotinib + BKM120|BKM120, administered 80 mg by mouth (PO) daily during the first week of Cycle 1, then escalated to 100 mg PO daily. Erlotinib, administered 100 mg PO daily. Each cycle is 28 days.
220982|NCT01487161|B5|Baseline|Total|Total of all reporting groups
220983|NCT01487161|B4|Baseline|TCA IR (40 mg)|Single 1 mL IA injection
220984|NCT01487161|B3|Baseline|FX006 60 mg|Single 3 mL IA injection
220985|NCT01487161|B2|Baseline|FX006 40 mg|Single 3 mL IA injection
220986|NCT01487161|B1|Baseline|FX006 10 mg|Single 3 mL IA injection
220987|NCT01487161|P4|Participant Flow|TCA IR (40 mg)|51 subjects received TCA IR 40 mg as a single 1 mL IA injection.
220988|NCT01487161|P3|Participant Flow|FX006 60 mg|60 subjects received FX006 60 mg as a single 3 mL IA injection.
220989|NCT01487161|P2|Participant Flow|FX006 40 mg|59 subjects received FX006 40 mg as a single 3 mL IA injection.
220990|NCT01487161|P1|Participant Flow|FX006 10 mg|58 subjects received FX006 10 mg as a single 3 mL IA injection.
220991|NCT01487161|O4|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
220992|NCT01487161|O3|Outcome|FX006 60 mg|FX006: Single 3 mL IA injection
220993|NCT01487161|O2|Outcome|FX006 40 mg|FX006: Single 3 mL IA injection
220994|NCT01487161|O1|Outcome|FX006 10 mg|FX006: Single 3 mL IA injection
220995|NCT01487161|O4|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
220996|NCT01487161|O3|Outcome|FX006 60 mg|FX006: Single 3 mL IA injection
220997|NCT01487161|O2|Outcome|FX006 40 mg|FX006: Single 3 mL IA injection
220998|NCT01487161|O1|Outcome|FX006 10 mg|FX006: Single 3 mL IA injection
220999|NCT01487161|O4|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
221000|NCT01487161|O3|Outcome|FX006 60 mg|FX006: Single 3 mL IA injection
221001|NCT01487161|O2|Outcome|FX006 40 mg|FX006: Single 3 mL IA injection
221002|NCT01487161|O1|Outcome|FX006 10 mg|FX006: Single 3 mL IA injection
221003|NCT01487161|O4|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
221004|NCT01487161|O3|Outcome|FX006 60 mg|FX006: Single 3 mL IA injection
221005|NCT01487161|O2|Outcome|FX006 40 mg|FX006: Single 3 mL IA injection
221006|NCT01487161|O1|Outcome|FX006 10 mg|FX006: Single 3 mL IA injection
221007|NCT01487161|O4|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
221008|NCT01487161|O3|Outcome|FX006 60 mg|FX006: Single 3 mL IA injection
221009|NCT01487161|O2|Outcome|FX006 40 mg|FX006: Single 3 mL IA injection
221010|NCT01487161|O1|Outcome|FX006 10 mg|FX006: Single 3 mL IA injection
221011|NCT01487161|O4|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
221012|NCT01487161|O3|Outcome|FX006 60 mg|FX006: Single 3 mL IA injection
221013|NCT01487161|O2|Outcome|FX006 40 mg|FX006: Single 3 mL IA injection
221014|NCT01487161|O1|Outcome|FX006 10 mg|FX006: Single 3 mL IA injection
221015|NCT01487161|O4|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
221016|NCT01487161|O3|Outcome|FX006 60 mg|FX006: Single 3 mL IA injection
221017|NCT01487161|O2|Outcome|FX006 40 mg|FX006: Single 3 mL IA injection
221018|NCT01487161|O1|Outcome|FX006 10 mg|FX006: Single 3 mL IA injection
221019|NCT01487161|O4|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
221020|NCT01487161|O3|Outcome|FX006 60 mg|FX006: Single 3 mL IA injection
221021|NCT01487161|O2|Outcome|FX006 40 mg|FX006: Single 3 mL IA injection
221022|NCT01487161|O1|Outcome|FX006 10 mg|FX006: Single 3 mL IA injection
221023|NCT01487161|O4|Outcome|TCA IR (40 mg)|TCA IR: Single 1 mL IA injection
221024|NCT01487161|O3|Outcome|FX006 60 mg|FX006: Single 3 mL IA injection
221025|NCT01487161|O2|Outcome|FX006 40 mg|FX006: Single 3 mL IA injection
221026|NCT01487161|O1|Outcome|FX006 10 mg|FX006: Single 3 mL IA injection
221027|NCT01487161|O4|Outcome|TCA IR 40 mg|FX006: Single 1 mL IA injection
221028|NCT01487161|O3|Outcome|FX006 60 mg|FX006: Single 3 mL IA injection
221029|NCT01487161|O2|Outcome|FX006 40 mg|FX006: Single 3 mL IA injection
221030|NCT01487161|O1|Outcome|FX006 10 mg|FX006: Single 3 mL IA injection
221031|NCT01487161|O4|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
221032|NCT01487161|O3|Outcome|FX006 60 mg|FX006: Single 3 mL IA injection
221033|NCT01487161|O2|Outcome|FX006 40 mg|FX006: Single 3 mL IA injection
221034|NCT01487161|O1|Outcome|FX006 10 mg|FX006: Single 3 mL IA injection
221035|NCT01487161|O4|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
221036|NCT01487161|O3|Outcome|FX006 60 mg|FX006: Single 3 mL IA injection
221037|NCT01487161|O2|Outcome|FX006 40 mg|FX006: Single 3 mL IA injection
221038|NCT01487161|O1|Outcome|FX006 10 mg|FX006: Single 3 mL IA injection
221039|NCT01487161|O3|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
221042|NCT01487161|O2|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
221043|NCT01487161|O1|Outcome|FX006 60 mg|FX006: Single 3 mL IA injection
221044|NCT01487161|O2|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
221045|NCT01487161|O1|Outcome|FX006 60 mg|FX006: Single 3 mL IA injection
221046|NCT01487161|O2|Outcome|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
221047|NCT01487161|O1|Outcome|FX006 60 mg|FX006: Single 3 mL IA injection
221048|NCT01487161|E4|Reported Event|TCA IR (40 mg)|TCA IR: Single 1 mL IA injection
221049|NCT01487161|E3|Reported Event|FX006 60 mg|FX006: Single 3 mL IA injection
221050|NCT01487161|E2|Reported Event|FX006 40 mg|FX006: Single 3 mL IA injection
221051|NCT01487161|E1|Reported Event|FX006 10 mg|FX006: Single 3 mL IA injection
221052|NCT01486966|B3|Baseline|Total|Total of all reporting groups
221053|NCT01486966|B2|Baseline|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
221054|NCT01486966|B1|Baseline|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
221055|NCT01486966|P2|Participant Flow|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
221056|NCT01486966|P1|Participant Flow|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
221057|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
221058|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
221059|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
221060|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
221061|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
221062|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
221063|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
221064|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
221065|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
221066|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
221067|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
221068|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
221069|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
242318|NCT01421667|O3|Outcome|CD30+ DLBCL, BV|
221070|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
221071|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
221072|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
221073|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
221074|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
221075|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
221076|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
221077|NCT01486966|E2|Reported Event|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
221078|NCT01486966|E1|Reported Event|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
221079|NCT01486927|B1|Baseline|Recombinant Factor VIII (rFVIII)|In Part 1 of the study (a single-sequence crossover PK analysis), 27 subjects received a single injection of octocog alfa followed by a single injection of rVIII-SingleChain. Twenty-six of the 27 subjects from Part 1 then entered Part 2 of the study where they were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs. In Part 3 of the study, 148 additional subjects were enrolled and were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs; 64 of these subjects participated in additional PK analyses. Overall, 174 subjects received rVIII-SingleChain as either on-demand or prophylaxis regimens, and 13 subjects participated in the surgical substudy.
221080|NCT01486927|P1|Participant Flow|Recombinant Factor VIII (rFVIII)|In Part 1 of the study (a single-sequence crossover pharmacokinetic [PK] analysis), 27 subjects received a single injection of octocog alfa followed by a single injection of rVIII-SingleChain. Twenty-six of the 27 subjects from Part 1 then entered Part 2 of the study where they were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 exposure days (EDs). In Part 3 of the study, 148 additional subjects were enrolled and were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs; 64 of these subjects participated in additional PK analyses. Overall, 174 subjects received rVIII-SingleChain as either on-demand or prophylaxis regimens, and 13 subjects participated in the surgical substudy.
221081|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
221082|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
221083|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
221084|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
221085|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
221156|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
221157|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
221158|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
221086|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
221087|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
221088|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
221089|NCT01486927|O3|Outcome|rVIII-SingleChain|The Efficacy population consisted of all subjects who received at least one dose of rVIII-SingleChain as part of either routine prophylaxis treatment or on-demand treatment during Parts 2 or 3 of the study. There were 173 subjects in the Efficacy population.
221090|NCT01486927|O2|Outcome|rVIII-SingleChain Prophylaxis|The rVIII-SingleChain Prophylaxis group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of routine prophylaxis treatment during Parts 2 or 3 of the study. There were 146 subjects in the rVIII-SingleChain Prophylaxis group.
221091|NCT01486927|O1|Outcome|rVIII-SingleChain On-demand|The rVIII-SingleChain On-demand group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of on-demand treatment during Parts 2 or 3 of the study. There were 27 subjects in the rVIII-SingleChain On-demand group.
221092|NCT01486927|O2|Outcome|rVIII-SingleChain Prophylaxis|The rVIII-SingleChain Prophylaxis group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of routine prophylaxis treatment during Parts 2 or 3 of the study. There were 146 subjects in the rVIII-SingleChain Prophylaxis group.
221093|NCT01486927|O1|Outcome|rVIII-SingleChain On-demand|The rVIII-SingleChain On-demand group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of on-demand treatment during Parts 2 or 3 of the study. There were 27 subjects in the rVIII-SingleChain On-demand group.
221094|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
221095|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
221096|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
221097|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
221098|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
221099|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
221100|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
221101|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
221102|NCT01486927|O1|Outcome|rVIII-SingleChain Surgical|The rVIII-SingleChain Surgical group included all subjects enrolled in the surgical sub-study who received at least 1 dose of rVIII-SingleChain during the surgical sub-study. There were 13 subjects in the rVIII-SingleChain Surgical group.
221103|NCT01486927|O2|Outcome|rVIII-SingleChain Prophylaxis|The rVIII-SingleChain Prophylaxis group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of routine prophylaxis treatment during Parts 2 or 3 of the study. There were 146 subjects in the rVIII-SingleChain Prophylaxis group.
221104|NCT01486927|O1|Outcome|rVIII-SingleChain On-demand|The rVIII-SingleChain On-demand group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of on-demand treatment during Parts 2 or 3 of the study. There were 27 subjects in the rVIII-SingleChain On-demand group.
221159|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
221160|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
221105|NCT01486927|O1|Outcome|Recombinant Factor VIII (rFVIII)|In Part 1 of the study (a single-sequence crossover PK analysis), 27 subjects received a single injection of octocog alfa followed by a single injection of rVIII-SingleChain. Twenty-six of the 27 subjects from Part 1 then entered Part 2 of the study where they were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs. In Part 3 of the study, 148 additional subjects were enrolled and were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs; 64 of these subjects participated in additional PK analyses. Overall, 174 subjects received rVIII-SingleChain as either on-demand or prophylaxis regimens, and 13 subjects participated in the surgical substudy.
221106|NCT01486927|O3|Outcome|rVIII-SingleChain|The Efficacy population consisted of all subjects who received at least 1 dose of rVIII-SingleChain as part of either routine prophylaxis treatment or on-demand treatment during Parts 2 or 3 of the study. There were 173 subjects in the Efficacy population.
221107|NCT01486927|O2|Outcome|rVIII-SingleChain Prophylaxis|The rVIII-SingleChain Prophylaxis group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of routine prophylaxis treatment during Parts 2 or 3 of the study. There were 146 subjects in the rVIII-SingleChain Prophylaxis group.
221108|NCT01486927|O1|Outcome|rVIII-SingleChain On-demand|The rVIII-SingleChain On-demand group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of on-demand treatment during Parts 2 or 3 of the study. There were 27 subjects in the rVIII-SingleChain On-demand group.
221109|NCT01486927|E1|Reported Event|Safety Population|The Safety Population comprised all subjects treated with rVIII-SingleChain.
221110|NCT01486758|B3|Baseline|Total|Total of all reporting groups
221111|NCT01486758|B2|Baseline|Placebo|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
221112|NCT01486758|B1|Baseline|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
221113|NCT01486758|P2|Participant Flow|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
221114|NCT01486758|P1|Participant Flow|Placebo|Placebo for 14 days.
221115|NCT01486758|O2|Outcome|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
221116|NCT01486758|O1|Outcome|Placebo|Placebo for 14 days.
221117|NCT01486758|O2|Outcome|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
221118|NCT01486758|O1|Outcome|Placebo|Placebo for 14 days.
221119|NCT01486758|O2|Outcome|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
221120|NCT01486758|O1|Outcome|Placebo|Placebo for 14 days.
221121|NCT01486758|O2|Outcome|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
221122|NCT01486758|O1|Outcome|Placebo|Placebo for 14 days.
221123|NCT01486758|O2|Outcome|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
221124|NCT01486758|O1|Outcome|Placebo|Placebo for 14 days.
221125|NCT01486758|O2|Outcome|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
221126|NCT01486758|O1|Outcome|Placebo|Placebo for 14 days.
221127|NCT01486758|O2|Outcome|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
221128|NCT01486758|O1|Outcome|Placebo|Placebo for 14 days.
221129|NCT01486758|O2|Outcome|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
221130|NCT01486758|O1|Outcome|Placebo|Placebo for 14 days
221131|NCT01486758|E2|Reported Event|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
221132|NCT01486758|E1|Reported Event|Placebo|Placebo for 14 days.
221133|NCT01486615|B5|Baseline|Total|Total of all reporting groups
221134|NCT01486615|B4|Baseline|Placebo|premedication 1-2 hr prior to anesthesia
221135|NCT01486615|B3|Baseline|Alprazolam|premedication 1-2 hr prior to anesthesia
221136|NCT01486615|B2|Baseline|Melatonin and Alprazolam|premedicated 1-2 hrs prior to anesthesia
221137|NCT01486615|B1|Baseline|Melatonin|premedication 1-2 hour prior to anesthesia
221138|NCT01486615|P4|Participant Flow|Placebo|Oral premedication with a similar looking placebo tablet 1-2 hr prior to anesthesia
221139|NCT01486615|P3|Participant Flow|Alprazolam|Oral premedication with 0.5 mg alprazolam (Alprax) 1-2 hr prior to anesthesia
221140|NCT01486615|P2|Participant Flow|Melatonin and Alprazolam|Oral premedication with a 3 mg melatonin and 0.5 mg alprazolam combination tablet (Stressnil) 1-2 hrs prior to anesthesia
221141|NCT01486615|P1|Participant Flow|Melatonin|Oral premedication with 3 mg melatonin tablet (Meloset) 1-2 hour prior to anesthesia
221142|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
221143|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
221144|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
221145|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
221146|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
221147|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
221148|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
221149|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
221150|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
221151|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
221152|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
221153|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
221154|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
221155|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
221161|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
221162|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
221163|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
221164|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
221165|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
221166|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
221167|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
221168|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
221169|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
221170|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
221171|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
221172|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
221173|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
221174|NCT01486615|E4|Reported Event|Placebo|premedication 1-2 hr prior to anesthesia
221175|NCT01486615|E3|Reported Event|Alprazolam|premedication 1-2 hr prior to anesthesia
221176|NCT01486615|E2|Reported Event|Melatonin and Alprazolam|premedicated 1-2 hrs prior to anesthesia
221177|NCT01486615|E1|Reported Event|Melatonin|premedication 1-2 hour prior to anesthesia
221178|NCT01486446|B3|Baseline|Total|Total of all reporting groups
221179|NCT01486446|B2|Baseline|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
221180|NCT01486446|B1|Baseline|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
221181|NCT01486446|P2|Participant Flow|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
221182|NCT01486446|P1|Participant Flow|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
221183|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
221184|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
221185|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
221186|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
221187|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
221188|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
221189|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
221190|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
221191|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
221192|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
221193|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
221194|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
221195|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
221196|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
221197|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
221198|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
221199|NCT01486446|E2|Reported Event|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
221200|NCT01486446|E1|Reported Event|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
221201|NCT01486238|B3|Baseline|Total|Total of all reporting groups
221202|NCT01486238|B2|Baseline|IVMac q4 Arm|Patients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Macugen® injection will be administered as described in the package insert.
221203|NCT01486238|B1|Baseline|IVMac q6 Arm|Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6week intervals beginning on Day 0 and ending at Week 18. Macugen® injection will be administered as described in the package insert.
221204|NCT01486238|P2|Participant Flow|IVMac q4 Arm|Patients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Macugen® injection will be administered as described in the package insert.
221205|NCT01486238|P1|Participant Flow|IVMac q6 Arm|Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6week intervals beginning on Day 0 and ending at Week 18. Macugen® injection will be administered as described in the package insert.
221206|NCT01486238|O2|Outcome|IVMac q4 Arm|Patients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Macugen® injection will be administered as described in the package insert.
221207|NCT01486238|O1|Outcome|IVMac q6 Arm|Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6week intervals beginning on Day 0 and ending at Week 18. Macugen® injection will be administered as described in the package insert.
221208|NCT01486238|E2|Reported Event|IVMac q4 Arm|Patients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Macugen® injection will be administered as described in the package insert.
221209|NCT01486238|E1|Reported Event|IVMac q6 Arm|Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6week intervals beginning on Day 0 and ending at Week 18. Macugen® injection will be administered as described in the package insert.
221210|NCT01486199|B3|Baseline|Total|Total of all reporting groups
221211|NCT01486199|B2|Baseline|Controls Adult|Adult control subjects 18 or older
221212|NCT01486199|B1|Baseline|CF Pediatric|Cystic Fibrosis subjects ages 6-14
221213|NCT01486199|P2|Participant Flow|Controls Adult|Adult control subjects 18 or older
221214|NCT01486199|P1|Participant Flow|CF Pediatric|Cystic Fibrosis subjects ages 6-14
221215|NCT01486199|O2|Outcome|Controls Adult|Adult control subjects 18 or older
221216|NCT01486199|O1|Outcome|CF Pediatric|CF subjects ages 6-14
221217|NCT01486199|O2|Outcome|Controls Adult|Adult control subjects 18 or older
221218|NCT01486199|O1|Outcome|CF Pediatric|CF subjects ages 6-14
221219|NCT01486199|O2|Outcome|Controls Adult|Adult control subjects 18 or older
221220|NCT01486199|O1|Outcome|CF Pediatric|CF subjects ages 6-14
221221|NCT01486199|O2|Outcome|Controls Adult|Adult control subjects 18 or older
221222|NCT01486199|O1|Outcome|CF Pediatric|CF subjects ages 6-14
221223|NCT01486199|E2|Reported Event|Controls Adult|adult controls 18 or older
221224|NCT01486199|E1|Reported Event|CF Pediatric|cystic fibrosis subjects ages 6-14
221225|NCT01486043|B1|Baseline|Metformin and Insulin Therapy|Patients receiving metformin and insulin therapy.
221226|NCT01486043|P1|Participant Flow|Metformin and Insulin Therapy|"For the prospectively recruited arm (metformin plus insulin therapy), a total of 4 subjects were recruited. Two subjects were withdrawn from the study after laboratory studies revealed liver enzymes (AST) levels that were above that allowed for the study at the time. An additional 2 subjects were recruited in the study.~For the retrospective chart review portion of our study, 12 patients were included after conducting chart review of cases from January 2007 to August 2011."
221227|NCT01486043|O1|Outcome|Metformin and Insulin Therapy|Patients receiving metformin and insulin therapy.
221228|NCT01486043|O1|Outcome|Metformin and Insulin Therapy|Patients receiving metformin and insulin therapy.
221229|NCT01486043|O1|Outcome|Metformin and Insulin Therapy|Patients receiving metformin and insulin therapy.
221230|NCT01486043|E1|Reported Event|Metformin and Insulin Therapy|Patients receiving metformin and insulin therapy.
221231|NCT01485991|B3|Baseline|Total|Total of all reporting groups
221232|NCT01485991|B2|Baseline|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
221233|NCT01485991|B1|Baseline|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
221234|NCT01485991|P2|Participant Flow|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
221235|NCT01485991|P1|Participant Flow|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
221236|NCT01485991|O2|Outcome|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
221237|NCT01485991|O1|Outcome|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
221238|NCT01485991|O2|Outcome|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
221239|NCT01485991|O1|Outcome|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
221240|NCT01485991|O2|Outcome|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
221241|NCT01485991|O1|Outcome|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
221242|NCT01485991|E2|Reported Event|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
221243|NCT01485991|E1|Reported Event|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
242319|NCT01421667|O2|Outcome|CD30+ Other B-Cell NHL, BV|
221244|NCT01485887|B1|Baseline|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
221245|NCT01485887|P1|Participant Flow|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
221246|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
221247|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
221248|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
221249|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
221250|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
221251|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
221269|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
221270|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
221252|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
221253|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
221254|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
221255|NCT01485887|E1|Reported Event|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
221256|NCT01485796|B1|Baseline|Subcutaneous Treatment With IGI, 10% and rHuPH20|This analysis set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2. In Epoch 1, PIDD patients that were already on intravenous (IV) or subcutaneous (SC) treatment were treated with IGI, 10% and rHuPH20 subcutaneously, with one 1-week dose and interval and one 2-week dose and interval. Epoch 2 was to consist of approx. 6 months (24 weeks) of IGI, 10% and rHuPH20 treatment. For subjects pretreated IV, this treatment was to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), depending on the subject´s previous IV dosing schedule. For subjects pretreated SC, treatment was also to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), at the discretion of the investigator and subject. However, treatment with rHuPH20 was stopped as of August 2012 following a discussion with the FDA, and subjects still active in Epoch 2 were switched to a safety follow-up (IGI, 10% by IV or SC route).
221257|NCT01485796|P1|Participant Flow|Subcutaneous Treatment With IGI, 10% and rHuPH20|Subcutaneous treatment with IGI, 10% and rHuPH20 occurred in 2 study epochs. In Epoch 1, PIDD patients that were already on intravenous (IV) or subcutaneous (SC) treatment were treated with IGI, 10% and rHuPH20 subcutaneously, with one 1-week dose and interval and one 2-week dose and interval. Epoch 2 was to consist of approx. 6 months (24 weeks) of IGI, 10% and rHuPH20 treatment. For subjects pretreated IV, this treatment was to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), depending on the subject´s previous IV dosing schedule. For subjects pretreated SC, treatment was also to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), at the discretion of the investigator and subject. However, treatment with rHuPH20 was stopped as of August 2012 following a discussion with the FDA, and subjects still active in Epoch 2 were switched to a safety follow-up. During the safety-follow up, subjects received IGI, 10% by either the IV or the SC route.
221258|NCT01485796|O1|Outcome|Epoch 2 Data Set (n=36)|The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
221259|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
221260|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
221261|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
221262|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
221263|NCT01485796|O1|Outcome|Epoch 2 Data Set|The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
221264|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
221265|NCT01485796|O2|Outcome|Epoch 2 Data Set (n=36)|The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
221266|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
221267|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
221268|NCT01485796|O2|Outcome|Epoch 2 Data Set (n=36)|The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
242320|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
221271|NCT01485796|O1|Outcome|Epoch 2 Data Set (n=36)|The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
221272|NCT01485796|O1|Outcome|Epoch 2 Data Set (n=36)|The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
221273|NCT01485796|O2|Outcome|Epoch 2 Data Set (n=36)|The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
221274|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
221275|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
221276|NCT01485796|E2|Reported Event|Safety Follow-up (n=26)|Treatment with rHuPH20 was stopped as of August 2012 following discussion with the FDA. This decision was based on theoretical risks of exposure to anti-rHuPH20 antibodies, not because of any clinical adverse events. 26 subjects still active in Epoch 2 of the study went into a safety follow-up period and were treated with IGI, 10% (GAMMAGARD LIQUID) either intravenously or subcutaneously.
221277|NCT01485796|E1|Reported Event|Epochs 1+2 (SC Treatment w/ IGI,10% and rHuPH20, n=37)|This analysis set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2. In Epoch 1, PIDD patients that were already on intravenous (IV) or subcutaneous (SC) treatment were treated with IGI, 10% and rHuPH20 subcutaneously, with one 1-week dose and interval and one 2-week dose and interval. Epoch 2 was to consist of approx. 6 months (24 weeks) of IGI, 10% and rHuPH20 treatment. For subjects pretreated IV, this treatment was to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), depending on the subject´s previous IV dosing schedule. For subjects pretreated SC, treatment was also to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), at the discretion of the investigator and subject. However, treatment with rHuPH20 was stopped as of August 2012 following a discussion with the FDA, and subjects still active in Epoch 2 were switched to a safety follow-up (IGI, 10% by IV or SC route).
221278|NCT01485640|B1|Baseline|Lurasidone|"Lurasidone flexibly dosed~Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food"
221279|NCT01485640|P1|Participant Flow|Lurasidone|"Lurasidone flexibly dosed~Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food"
221280|NCT01485640|O1|Outcome|Lurasidone|"Lurasidone flexibly dosed~Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food"
221281|NCT01485640|O1|Outcome|Lurasidone|"Lurasidone flexibly dosed~Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food"
221282|NCT01485640|E1|Reported Event|Lurasidone|"Lurasidone flexibly dosed~Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food"
221283|NCT01485536|B1|Baseline|AUY922|AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
221284|NCT01485536|P1|Participant Flow|AUY922|AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
221285|NCT01485536|O1|Outcome|AUY922|AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
221286|NCT01485536|O1|Outcome|AUY922|AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
221287|NCT01485536|E1|Reported Event|AUY922|AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
221288|NCT01485380|B1|Baseline|Active Study Arm|"Subjects recruited into this study will be required to undergo two MRI-PET scans of the brain in addition to high density electroencephalogram acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused.~dexmedetomidine: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli."
221289|NCT01485380|P1|Participant Flow|Active Study Arm|"Subjects recruited into this study will be required to undergo two magnetic resonance imaging-positron emission tomography scans of the brain in addition to high density electroencephalogram acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused.~dexmedetomidine: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli."
221290|NCT01485380|O1|Outcome|Active Study Arm|"Subjects recruited into this study will be required to undergo two magnetic resonance imaging-positron emission tomography (MRI-PET) scans of the brain in addition to high density electroencephalogram (EEG) acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused.~dexmedetomidine: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss on consciousness is initially observed. Loss on consciousness will be assayed by specific auditory and verbal stimuli."
221291|NCT01485380|E1|Reported Event|Active Study Arm|"Subjects recruited into this study will be required to undergo two MR-PET scans of the brain in addition to high density EEG acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused.~dexmedetomidine: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli."
221292|NCT01485354|B1|Baseline|Armeo Spring Training|"Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).~Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks"
221293|NCT01485354|P1|Participant Flow|Armeo Spring Training|"Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).~Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks"
221294|NCT01485354|O1|Outcome|Armeo Spring Training|"Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).~Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks"
221467|NCT01484834|B4|Baseline|Control Company|Participants did not receive any intervention
221295|NCT01485354|O1|Outcome|Armeo Spring Training|"Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).~Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks"
221296|NCT01485354|O1|Outcome|Armeo Spring Training|"Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).~Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks"
221297|NCT01485354|O1|Outcome|Armeo Spring Training|"Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).~Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks"
221298|NCT01485354|O1|Outcome|Armeo Spring Training|"Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).~Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks"
221299|NCT01485354|E1|Reported Event|Armeo Spring Training|"Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).~Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks"
221300|NCT01485172|B7|Baseline|Total|Total of all reporting groups
221301|NCT01485172|B6|Baseline|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221302|NCT01485172|B5|Baseline|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221303|NCT01485172|B4|Baseline|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221304|NCT01485172|B3|Baseline|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221305|NCT01485172|B2|Baseline|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221306|NCT01485172|B1|Baseline|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
221307|NCT01485172|P6|Participant Flow|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221308|NCT01485172|P5|Participant Flow|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221309|NCT01485172|P4|Participant Flow|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221310|NCT01485172|P3|Participant Flow|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221311|NCT01485172|P2|Participant Flow|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221312|NCT01485172|P1|Participant Flow|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
242321|NCT01421667|O1|Outcome|CD30+ DLBCL, BV+R|
221313|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221314|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221315|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221316|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221317|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221318|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
221319|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221320|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221321|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221322|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221323|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221324|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
221325|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221326|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221327|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221360|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
221468|NCT01484834|B3|Baseline|Educational Intervention|Participants received educational intervention only
221328|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221329|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221330|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
221331|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221332|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221333|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221334|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221335|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221336|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
221337|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221338|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221339|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221340|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221341|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221342|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
221343|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221399|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
221344|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221345|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221346|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221347|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221348|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
221349|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221350|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221351|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221352|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221353|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221354|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
221355|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221356|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221357|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221358|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221359|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221361|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221362|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221363|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221364|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221365|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221366|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
221367|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221368|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221369|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221370|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221371|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221372|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
221373|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221374|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221375|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221400|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
244948|NCT01409837|B3|Baseline|Total|Total of all reporting groups
221376|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221377|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221378|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
221379|NCT01485172|E6|Reported Event|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221380|NCT01485172|E5|Reported Event|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221381|NCT01485172|E4|Reported Event|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221382|NCT01485172|E3|Reported Event|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221383|NCT01485172|E2|Reported Event|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
221384|NCT01485172|E1|Reported Event|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
221385|NCT01485094|B4|Baseline|Total|Total of all reporting groups
221386|NCT01485094|B3|Baseline|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
221387|NCT01485094|B2|Baseline|GRT6010|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~GRT6010: Oral solution given once daily."
221388|NCT01485094|B1|Baseline|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
221389|NCT01485094|P3|Participant Flow|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
221390|NCT01485094|P2|Participant Flow|GRT6010|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~GRT6010: Oral solution given once daily."
221391|NCT01485094|P1|Participant Flow|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo: Matching Placebo capsules to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
221392|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
221393|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
221394|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
221395|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
221396|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
221397|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
221398|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
221401|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
221402|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
221403|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
221404|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
221405|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
221406|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
221407|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
221408|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
221409|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
221410|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
221411|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
221412|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
221413|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
221414|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
221415|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
221416|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
221417|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
221418|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
221419|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
221420|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
221421|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
221422|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
221423|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
221424|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
221425|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
221426|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
221427|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
221428|NCT01485094|E3|Reported Event|Pregabalin|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~Pregabalin: Pregabalin capsules 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
221429|NCT01485094|E2|Reported Event|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
221464|NCT01484873|O1|Outcome|Exenatide|exenatide 10 mcg twice daily
221465|NCT01484873|E1|Reported Event|Exenatide|exenatide 10 mcg twice daily
221430|NCT01485094|E1|Reported Event|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~Matching Placebo: Matching Placebo capsules to the Pregabalin capsules and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
221431|NCT01484977|B1|Baseline|Lacosamide|"Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).~Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.~Maximum duration of study drug administration is approximately 23 weeks."
221432|NCT01484977|P1|Participant Flow|Lacosamide|"Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).~Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.~Maximum duration of study drug administration is approximately 23 weeks."
221433|NCT01484977|O1|Outcome|Lacosamide|"Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).~Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.~Maximum duration of study drug administration is approximately 23 weeks."
221434|NCT01484977|E1|Reported Event|Lacosamide|"Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).~Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.~Maximum duration of study drug administration is approximately 23 weeks."
221435|NCT01484951|B1|Baseline|AZARGA|Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
221436|NCT01484951|P1|Participant Flow|AZARGA|Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
221437|NCT01484951|O1|Outcome|AZARGA|Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
221438|NCT01484951|O1|Outcome|AZARGA|Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
221439|NCT01484951|E1|Reported Event|AZARGA|Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
221440|NCT01484938|B1|Baseline|OPTI-FREE|Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
221441|NCT01484938|P1|Participant Flow|OPTI-FREE|Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
221442|NCT01484938|O1|Outcome|OPTI-FREE|Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
221443|NCT01484938|O1|Outcome|OPTI-FREE|Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
221444|NCT01484938|E1|Reported Event|OPTI-FREE|Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
221445|NCT01484912|B3|Baseline|Total|Total of all reporting groups
221446|NCT01484912|B2|Baseline|Placebo|"Placebo capsule, containing non-active ingredients.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
221447|NCT01484912|B1|Baseline|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
221448|NCT01484912|P2|Participant Flow|Placebo|"Placebo capsule, containing non-active ingredients.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
221449|NCT01484912|P1|Participant Flow|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
221450|NCT01484912|O2|Outcome|Placebo|"Placebo capsule, containing non-active ingredients.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
221451|NCT01484912|O1|Outcome|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
221452|NCT01484912|O2|Outcome|Placebo|"Placebo capsule, containing non-active ingredients.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
221453|NCT01484912|O1|Outcome|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
221454|NCT01484912|O2|Outcome|Placebo|"Placebo capsule, containing non-active ingredients.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
221455|NCT01484912|O1|Outcome|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
221456|NCT01484912|E2|Reported Event|Placebo|"Placebo capsule, containing non-active ingredients.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
221457|NCT01484912|E1|Reported Event|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
221458|NCT01484873|B1|Baseline|Exenatide|exenatide 10 mcg twice daily
221459|NCT01484873|P1|Participant Flow|Exenatide|exenatide 10 mcg twice daily
221460|NCT01484873|O1|Outcome|Exenatide|exenatide 10 mcg twice daily
221461|NCT01484873|O1|Outcome|Exenatide|exenatide 10 mcg twice daily
221462|NCT01484873|O1|Outcome|Exenatide|Exenatide: Treatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks.
221463|NCT01484873|O1|Outcome|Exenatide|exenatide 10 mcg twice daily
221469|NCT01484834|B2|Baseline|Exercise in the Workplace|Participants received exercise only
221470|NCT01484834|B1|Baseline|Exercise in the Workplace and Educational Intervention|Participants received exercise in the workplace and educational intervention
221471|NCT01484834|P4|Participant Flow|Control Company|No intervention. Control group received no intervention during study period
221472|NCT01484834|P3|Participant Flow|Educational Intervention|"This company received a quality of life software and poster with tips on health lifestyle.~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
221473|NCT01484834|P2|Participant Flow|Exercise in the Workplace|"Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
221474|NCT01484834|P1|Participant Flow|Exercise in the Workplace and Educational Intervention|"Company A received exercise in the workplace, posters with tips on health and quality of life computer software~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
221475|NCT01484834|O4|Outcome|Control Company|No intervention. Control group received no intervention during study period
221476|NCT01484834|O3|Outcome|Educational Intervention|"This company received a quality of life software and poster with tips on health lifestyle.~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
221477|NCT01484834|O2|Outcome|Exercise in the Workplace|"Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
221478|NCT01484834|O1|Outcome|Exercise in the Workplace and Educational Intervention|"Company A received exercise in the workplace, posters with tips on health and quality of life computer software~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
221479|NCT01484834|O4|Outcome|Control Company|No intervention. Control group received no intervention during study period
221480|NCT01484834|O3|Outcome|Educational Intervention|"This company received a quality of life software and poster with tips on health lifestyle.~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
221481|NCT01484834|O2|Outcome|Exercise in the Workplace|"Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
221482|NCT01484834|O1|Outcome|Exercise in the Workplace and Educational Intervention|"Company A received exercise in the workplace, posters with tips on health and quality of life computer software~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
221483|NCT01484834|O4|Outcome|Control Company|No intervention. Control group received no intervention during study period
221484|NCT01484834|O3|Outcome|Educational Intervention|"This company received a quality of life software and poster with tips on health lifestyle.~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
221485|NCT01484834|O2|Outcome|Exercise in the Workplace|"Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
221486|NCT01484834|O1|Outcome|Exercise in the Workplace and Educational Intervention|"Company A received exercise in the workplace, posters with tips on health and quality of life computer software~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
221487|NCT01484834|O4|Outcome|Control Company|No intervention. Control group received no intervention during study period
221488|NCT01484834|O3|Outcome|Educational Intervention|"This company received a quality of life software and poster with tips on health lifestyle.~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
221489|NCT01484834|O2|Outcome|Exercise in the Workplace|"Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
221490|NCT01484834|O1|Outcome|Exercise in the Workplace and Educational Intervention|"Company A received exercise in the workplace, posters with tips on health and quality of life computer software~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
221491|NCT01484834|O4|Outcome|Control Company|No intervention. Control group received no intervention during study period
221492|NCT01484834|O3|Outcome|Educational Intervention|"This company received a quality of life software and poster with tips on health lifestyle.~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
221493|NCT01484834|O2|Outcome|Exercise in the Workplace|"Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
221494|NCT01484834|O1|Outcome|Exercise in the Workplace and Educational Intervention|"Company A received exercise in the workplace, posters with tips on health and quality of life computer software~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
221495|NCT01484834|E4|Reported Event|Control Company|No intervention. Control group received no intervention during study period
221496|NCT01484834|E3|Reported Event|Educational Intervention|"This company received a quality of life software and poster with tips on health lifestyle.~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
221497|NCT01484834|E2|Reported Event|Exercise in the Workplace|"Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
221498|NCT01484834|E1|Reported Event|Exercise in the Workplace and Educational Intervention|"Company A received exercise in the workplace, posters with tips on health and quality of life computer software~Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
221499|NCT01484652|B3|Baseline|Total|Total of all reporting groups
221500|NCT01484652|B2|Baseline|Placebo|2 tablets taken every 12 hours
221501|NCT01484652|B1|Baseline|COV795|2 tablets taken every 12 hours
221502|NCT01484652|P2|Participant Flow|Placebo|2 tablets taken every 12 hours at Hour 0, 12, 24, and 36; total of 4 doses
221503|NCT01484652|P1|Participant Flow|COV795|2 tablets taken every 12 hours at Hour 0, 12, 24, and 36; total of 4 doses
221504|NCT01484652|O2|Outcome|Placebo|2 tablets taken every 12 hours
221505|NCT01484652|O1|Outcome|COV795|2 tablets taken every 12 hours
221506|NCT01484652|E2|Reported Event|Placebo|2 tablets taken every 12 hours
221507|NCT01484652|E1|Reported Event|COV795|2 tablets taken every 12 hours
221508|NCT01484561|B3|Baseline|Total|Total of all reporting groups
221509|NCT01484561|B2|Baseline|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221510|NCT01484561|B1|Baseline|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221511|NCT01484561|P2|Participant Flow|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221512|NCT01484561|P1|Participant Flow|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221513|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221514|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221515|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221516|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221517|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221518|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221519|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221520|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221521|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221647|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
221522|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221523|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221524|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221525|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221526|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221527|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221528|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221529|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221530|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221531|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221532|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221533|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221534|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221535|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221536|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221537|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221538|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221539|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221540|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221541|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221542|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221543|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221544|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221545|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221546|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221547|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221648|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
221548|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221549|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221550|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221551|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221552|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221553|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221554|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221555|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221556|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221557|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221558|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221559|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221560|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221561|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221562|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221563|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221564|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221565|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221566|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221567|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221568|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221569|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221570|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221571|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221572|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221573|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221649|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
221574|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221575|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221576|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221577|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221578|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221579|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221580|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221581|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221582|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221583|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221584|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221585|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221586|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221587|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221588|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221589|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221590|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221591|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221592|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221593|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221594|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221595|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221596|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221597|NCT01484561|E2|Reported Event|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
221598|NCT01484561|E1|Reported Event|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
221599|NCT01484496|B3|Baseline|Total|Total of all reporting groups
221600|NCT01484496|B2|Baseline|Belimumab 200 mg SC|Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
223432|NCT01477567|O7|Outcome|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
221601|NCT01484496|B1|Baseline|Placebo SC|Par. received placebo administered SC, once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
221602|NCT01484496|P4|Participant Flow|Open-Label - Belimumab 200 SC to Belimumab 200 mg SC|Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly
221603|NCT01484496|P3|Participant Flow|Open-Label - Placebo SC to Belimumab 200 mg SC|Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly.
221604|NCT01484496|P2|Participant Flow|Belimumab 200 mg SC|Par. received belimumab 200 milligrams (mg) administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
221605|NCT01484496|P1|Participant Flow|Placebo SC|Par. received placebo administered subcutaneously (SC) once weekly through 51 weeks of thetreatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
221606|NCT01484496|O2|Outcome|Belimumab 200 mg SC|Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
221607|NCT01484496|O1|Outcome|Placebo SC|Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
221608|NCT01484496|O2|Outcome|Belimumab 200 mg SC|Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
221609|NCT01484496|O1|Outcome|Placebo SC|Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
221610|NCT01484496|O2|Outcome|Belimumab 200 mg SC|Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
221611|NCT01484496|O1|Outcome|Placebo SC|Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
221612|NCT01484496|E4|Reported Event|Open-Label - Belimumab 200 SC to Belimumab 200 mg SC|Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly.
221613|NCT01484496|E3|Reported Event|Open-Label - Placebo SC to Belimumab 200 mg SC|Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly.
221614|NCT01484496|E2|Reported Event|Belimumab 200 mg SC|Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
221615|NCT01484496|E1|Reported Event|Placebo SC|Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
221616|NCT01484314|B1|Baseline|Migration Arm|"Administration of eltrombopag to support platelets during chemotherapy~Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy"
221617|NCT01484314|P1|Participant Flow|Migration Arm|"Administration of eltrombopag to support platelets during chemotherapy~Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy"
221618|NCT01484314|O1|Outcome|Migration Arm|"Administration of eltrombopag to support platelets during chemotherapy~Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy"
221619|NCT01484314|O1|Outcome|Migration Arm|"Administration of eltrombopag to support platelets during chemotherapy~Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy"
221620|NCT01484314|O1|Outcome|Migration Arm|"Administration of eltrombopag to support platelets during chemotherapy~Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy"
221621|NCT01484314|E1|Reported Event|Migration Arm|"Administration of eltrombopag to support platelets during chemotherapy~Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy"
221622|NCT01484197|B1|Baseline|All Participants|All participants randomized to one of four treatment sequences.
221650|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
221651|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
221652|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
221623|NCT01484197|P4|Participant Flow|Sequence 4|Treatment Period 1: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
221624|NCT01484197|P3|Participant Flow|Sequence 3|Treatment Period 1: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
221625|NCT01484197|P2|Participant Flow|Sequence 2|Treatment Period 1: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM ) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
221626|NCT01484197|P1|Participant Flow|Sequence 1|Treatment Period 1: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
221627|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
221628|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
221629|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
221630|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
221631|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
221632|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
221633|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
221634|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
221635|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
221636|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
221637|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
221638|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
221639|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
221640|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
221641|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
221642|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
221643|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
221644|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
221645|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
221646|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
246731|NCT01402115|O1|Outcome|Polycan|Polycan 150mg for 12 weeks
221653|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
221654|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
221655|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
221656|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
221657|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
221658|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
221659|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
221660|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
221661|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
221662|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
221663|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
221664|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
221665|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
221666|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
221667|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
221668|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
221669|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
221670|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
221671|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
221672|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
221673|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
221674|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
221675|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
221676|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
221677|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
221678|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
221679|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
221680|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
221681|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
221682|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
221683|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
221684|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
221685|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
221686|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
221687|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
221688|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
221689|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
221690|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
221691|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
221692|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
221693|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
221694|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
221695|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
221696|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
221697|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
221698|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
221699|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
221700|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
221701|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
221702|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
221703|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
221704|NCT01484197|E4|Reported Event|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
221705|NCT01484197|E3|Reported Event|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
221706|NCT01484197|E2|Reported Event|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
221707|NCT01484197|E1|Reported Event|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
221708|NCT01484132|B1|Baseline|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
221709|NCT01484132|P1|Participant Flow|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
221710|NCT01484132|O1|Outcome|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
221711|NCT01484132|O1|Outcome|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
221712|NCT01484132|O1|Outcome|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
221713|NCT01484132|O1|Outcome|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
221714|NCT01484132|O1|Outcome|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
221715|NCT01484132|E1|Reported Event|Composite|Restoration of dental caries with dental composite: Dental Resin Restoration (bisphenol A diglycidyl ether methacrylate based composite)
221716|NCT01484054|B1|Baseline|All Subjects|All enrolled subjects who received study lenses.
221717|NCT01484054|P2|Participant Flow|EADE/EAPVPDE|etafilcon A control lens worn daily during the first period of 7-9 days then etafilcon A with embedded print and PVP for dark eyes lens worn daily during the second period of 7-9 days with a 1-3 day of wash-out time between 2 periods.
221718|NCT01484054|P1|Participant Flow|EAPVPDE/EADE|etafilcon A with embedded print and PVP for dark eyes lens worn daily during the first period of 7-9 days then etafilcon A control lens worn daily during the second period of 7-9 days with a 1-3 day of wash-out time between 2 periods.
221719|NCT01484054|O2|Outcome|EADE|A marketed daily disposable contact lens
221720|NCT01484054|O1|Outcome|EAPVPDE|A daily disposable contact lens
221721|NCT01484054|O2|Outcome|EADE|A marketed daily disposable contact lens
221722|NCT01484054|O1|Outcome|EAPVPDE|A daily disposable contact lens
221723|NCT01484054|O2|Outcome|EADE|A marketed daily disposable contact lens
221724|NCT01484054|O1|Outcome|EAPVPDE|A daily disposable contact lens.
221725|NCT01484054|E2|Reported Event|EADE|etafilcon a existing, daily disposable contact lens.
221726|NCT01484054|E1|Reported Event|EAPVPDE|etafilcon A material incorporating PVP in the blister packaging solution.
221727|NCT01484041|B1|Baseline|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
221728|NCT01484041|P1|Participant Flow|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
221729|NCT01484041|O1|Outcome|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
221730|NCT01484041|O1|Outcome|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
221731|NCT01484041|O1|Outcome|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
221732|NCT01484041|O1|Outcome|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
225438|NCT01472939|O4|Outcome|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
221733|NCT01484041|O1|Outcome|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
221734|NCT01484041|E1|Reported Event|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
221735|NCT01484028|B1|Baseline|All Subjects|All randomized subjects who worn at least one pair of study lenses.
221736|NCT01484028|P4|Participant Flow|EALE/1DM|etafilcon A for light eyes worn daily during the first period of 7-9 days then etafilcon A control lens worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
221737|NCT01484028|P3|Participant Flow|EADE/1DM|etafilcon A for dark eyes worn daily during the first period of 7-9 days then etafilcon A control lens worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
221738|NCT01484028|P2|Participant Flow|1DM/EALE|etafilcon A control lens worn daily during the first period of 7-9 days then etafilcon A for light eyes worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
221739|NCT01484028|P1|Participant Flow|1DM/EADE|etafilcon A control lens worn daily during the first period of 7-9 days then etafilcon A for dark eyes worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
221740|NCT01484028|O2|Outcome|1-DM|A marketed daily disposable contact lenses to correct myopia, two were discontinued between the first and second periods.
221741|NCT01484028|O1|Outcome|EADE/EALE|etafilcon A with embedded print and PVP for dark/light eyes to correct myopia.
221742|NCT01484028|O2|Outcome|1-DM|A marketed daily disposable contact lenses to correct myopia.
221743|NCT01484028|O1|Outcome|EADE/EALE|etafilcon A with embedded print and PVP for dark/light eyes to correct myopia.
221744|NCT01484028|O2|Outcome|1-DM|A marketed daily disposable contact lens to correct myopia.
221745|NCT01484028|O1|Outcome|EADE/EALE|etafilcon A with embedded print and PVP for dark/light eyes to correct myopia.
221746|NCT01484028|E2|Reported Event|Etafilcon A Control Lenses|A marketed daily disposable contact lens to correct myopia.
221747|NCT01484028|E1|Reported Event|Etafilcon A With PVP for Dark/Light Eyes|A daily disposable contact lens to correct myopia.
221748|NCT01483963|B6|Baseline|Total|Total of all reporting groups
221749|NCT01483963|B5|Baseline|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221750|NCT01483963|B4|Baseline|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221751|NCT01483963|B3|Baseline|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221752|NCT01483963|B2|Baseline|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221753|NCT01483963|B1|Baseline|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221754|NCT01483963|P5|Participant Flow|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221755|NCT01483963|P4|Participant Flow|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221756|NCT01483963|P3|Participant Flow|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221757|NCT01483963|P2|Participant Flow|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221758|NCT01483963|P1|Participant Flow|AA4500 0.29 mg/1 mL|"Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221759|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221760|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221761|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221762|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221763|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221764|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221765|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221766|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221767|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221768|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221769|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221770|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221771|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
225439|NCT01472939|O3|Outcome|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
221772|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221773|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221774|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221775|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221776|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221777|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221778|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221779|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221780|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221781|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221782|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221783|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221784|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221785|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221786|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221787|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221788|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221789|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221790|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221791|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221792|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221793|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221794|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221795|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221796|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221797|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221798|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221799|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221800|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221801|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221802|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221803|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221804|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221805|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221806|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221807|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221808|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221809|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221810|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221811|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221812|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221813|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221814|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221815|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221816|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221817|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221818|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221819|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221820|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221821|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221822|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221823|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221824|NCT01483963|E5|Reported Event|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221825|NCT01483963|E4|Reported Event|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221826|NCT01483963|E3|Reported Event|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221827|NCT01483963|E2|Reported Event|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221828|NCT01483963|E1|Reported Event|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
221829|NCT01483937|B3|Baseline|Total|Total of all reporting groups
221830|NCT01483937|B2|Baseline|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
221831|NCT01483937|B1|Baseline|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
221832|NCT01483937|P2|Participant Flow|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
221833|NCT01483937|P1|Participant Flow|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
221834|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|"Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.~Usual care physical therapy plus SEMD: Patients received standard care physical therapy while wearing SEMD. SEMD protocols were provided to device subjects."
221835|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|"Subjects received usual physical therapy intervention provided by vestibular and balance specialists.~Conventional physical therapy only: Subjects received standard care physical therapy from vestibular and balance specialists."
221836|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|"Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.~Usual care physical therapy plus SEMD: Patients received standard care physical therapy while wearing SEMD. SEMD protocols were provided to device subjects."
221837|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|"Subjects received usual physical therapy intervention provided by vestibular and balance specialists.~Conventional physical therapy only: Subjects received standard care physical therapy from vestibular and balance specialists."
221838|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|"Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.~Usual care physical therapy plus SEMD: Patients received standard care physical therapy while wearing SEMD. SEMD protocols were provided to device subjects."
221839|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|"Subjects received usual physical therapy intervention provided by vestibular and balance specialists.~Conventional physical therapy only: Subjects received usual care physical therapy from vestibular and balance specialists."
221840|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|"Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.~Usual care physical therapy plus SEMD: Patients received standard care physical therapy while wearing SEMD. SEMD protocols were provided to device subjects."
221841|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|"Subjects received usual physical therapy intervention provided by vestibular and balance specialists.~Conventional physical therapy only: Subjects received standard care physical therapy from vestibular and balance specialists."
221842|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
221843|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
221844|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
221845|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
221846|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
246732|NCT01402115|O2|Outcome|Placebo|Placebo 15mg for 12 weeks
221847|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
221848|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
221849|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
221850|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
221851|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
221852|NCT01483937|E2|Reported Event|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
221853|NCT01483937|E1|Reported Event|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
221854|NCT01483924|B6|Baseline|Total|Total of all reporting groups
221855|NCT01483924|B5|Baseline|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
221856|NCT01483924|B4|Baseline|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
221857|NCT01483924|B3|Baseline|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
221858|NCT01483924|B2|Baseline|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
221859|NCT01483924|B1|Baseline|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
221860|NCT01483924|P5|Participant Flow|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
221861|NCT01483924|P4|Participant Flow|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
221862|NCT01483924|P3|Participant Flow|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
221863|NCT01483924|P2|Participant Flow|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
221864|NCT01483924|P1|Participant Flow|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
221865|NCT01483924|O5|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
221866|NCT01483924|O4|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
221867|NCT01483924|O3|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
221868|NCT01483924|O2|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
221869|NCT01483924|O1|Outcome|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
221870|NCT01483924|O5|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
221871|NCT01483924|O4|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
221872|NCT01483924|O3|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
221873|NCT01483924|O2|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
221874|NCT01483924|O1|Outcome|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
221875|NCT01483924|O5|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
221876|NCT01483924|O4|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
221877|NCT01483924|O3|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
221878|NCT01483924|O2|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
221879|NCT01483924|O1|Outcome|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
221880|NCT01483924|O5|Outcome|Apo805K1 100 mg|Patients in this treatment group took two 50 mg tablets of Apo805K1 daily for 12 weeks
221881|NCT01483924|O4|Outcome|Apo805K1 60 mg|Patients in this treatment group took one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
221882|NCT01483924|O3|Outcome|Apo805K1 30 mg|Patients in this treatment group took three 10 mg tablets of Apo805K1 daily for 12 weeks
221883|NCT01483924|O2|Outcome|Apo805K1 10 mg|Patients in this treatment group took a single 10 mg tablet of Apo805K1 daily for 12 weeks
221963|NCT01483599|P11|Participant Flow|CNTO1959 50 mg (After CP)|Participants who received CNTO1959 50 mg and completed controlled period continued to receive CNTO1959 50 mg starting at Week 16 and once in every 12 weeks through Week 40.
221884|NCT01483924|O1|Outcome|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to take placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
221885|NCT01483924|O4|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
221886|NCT01483924|O3|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
221887|NCT01483924|O2|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
221888|NCT01483924|O1|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
221889|NCT01483924|O4|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
221890|NCT01483924|O3|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
221891|NCT01483924|O2|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
221892|NCT01483924|O1|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
221893|NCT01483924|O4|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
221894|NCT01483924|O3|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
221895|NCT01483924|O2|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
221896|NCT01483924|O1|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
221897|NCT01483924|O4|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
221898|NCT01483924|O3|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
221899|NCT01483924|O2|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
221900|NCT01483924|O1|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
221901|NCT01483924|O5|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
221902|NCT01483924|O4|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
221903|NCT01483924|O3|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
221904|NCT01483924|O2|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
221905|NCT01483924|O1|Outcome|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
221906|NCT01483924|E5|Reported Event|Apo805K1 100 mg|Patients in this treatment group took two 50 mg tablets of Apo805K1 daily for 12 weeks
221907|NCT01483924|E4|Reported Event|Apo805K1 60 mg|Patients in this treatment group took one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
221908|NCT01483924|E3|Reported Event|Apo805K1 30 mg|Patients in this treatment group took three 10 mg tablets of Apo805K1 daily for 12 weeks
221909|NCT01483924|E2|Reported Event|Apo805K1 10 mg|Patients in this treatment group took a single 10 mg tablet of Apo805K1 daily for 12 weeks
221910|NCT01483924|E1|Reported Event|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to take placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
221911|NCT01483820|B1|Baseline|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
221912|NCT01483820|P1|Participant Flow|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
221913|NCT01483820|O1|Outcome|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
221914|NCT01483820|O1|Outcome|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
221915|NCT01483820|O1|Outcome|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
221916|NCT01483820|O1|Outcome|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
221917|NCT01483820|O1|Outcome|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
221918|NCT01483820|O1|Outcome|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
221919|NCT01483820|E1|Reported Event|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
221920|NCT01483651|B1|Baseline|All Study Participants|Regular insulin given at each of three study visits with a different infusion rate at each visit, either low, medium or high insulin infusion with glucagon administration.
221921|NCT01483651|P6|Participant Flow|High, Medium and Low Insulin Infusion|"All study subjects in this arm were randomized as follows:~First study is regular insulin infused at highest level with glucagon administration.~Second study is regular insulin infused at medium level with glucagon adminstration.~Third study is regular insulin infused at lowest level with glucagon administration."
221964|NCT01483599|P10|Participant Flow|CNTO1959 15 mg (After CP)|Participants who received CNTO1959 15 mg and completed controlled period continued to receive CNTO1959 15 mg starting at Week 16 and once in every 8 weeks through Week 40.
246733|NCT01402115|O1|Outcome|Polycan|Polycan 150mg for 12 weeks
221922|NCT01483651|P5|Participant Flow|High, Low and Medium Insulin Infusion|"All study subjects in this arm were randomized as follows:~First study is regular insulin infused at highest level with glucagon administration.~Second study is regular insulin infused at lowest level with glucagon adminstration.~Third study is regular insulin infused at medium level with glucagon administration."
221923|NCT01483651|P4|Participant Flow|Medium, High and Low Insulin Infusion|"All study subjects in this arm were randomized as follows:~First study is regular insulin infused at medium level with glucagon administration.~Second study is regular insulin infused at highest level with glucagon adminstration.~Third study is regular insulin infused at lowest level with glucagon administration."
221924|NCT01483651|P3|Participant Flow|Medium, Low and High Insulin Infusion Rate|"All study subjects in this arm were randomized as follows:~First study is regular insulin infused at medium level with glucagon administration.~Second study is regular insulin infused at lowest level with glucagon adminstration.~Third study is regular insulin infused at highest level with glucagon administration."
221925|NCT01483651|P2|Participant Flow|Low, High and Medium Insulin Infusion Rate|"All study subjects in this arm were randomized as follows:~First study is regular insulin infused at lowest level with glucagon administration.~Second study is regular insulin infused at highest level with glucagon adminstration.~Third study is regular insulin infused at medium level with glucagon administration."
221926|NCT01483651|P1|Participant Flow|Low, Medium and High Insulin Infusion Rate|"All study subjects in this arm were randomized as follows:~First study is regular insulin infused at lowest level with glucagon administration.~Second study is regular insulin infused at medium level with glucagon adminstration.~Third study is regular insulin infused at highest level with glucagon administration."
221927|NCT01483651|O3|Outcome|High Insulin Infusion Rate|Regular insulin infused at highest level with glucagon administration.
221928|NCT01483651|O2|Outcome|Medium Insulin Infusion Rate|Regular insulin infused at medium level with glucagon administration.
221929|NCT01483651|O1|Outcome|Low Insulin Infusion Rate|Regular insulin infused at lowest level of glucagon administration.
221930|NCT01483651|E3|Reported Event|High Insulin Infusion|regular insulin infused at highest level with glucagon administration.
221931|NCT01483651|E2|Reported Event|Medium Insulin Infusion|Regular insulin infused at medium level with glucagon administration.
221932|NCT01483651|E1|Reported Event|Low Insulin Infusion|Regular insulin infused at lowest level with glucagon administration.
221933|NCT01483625|B3|Baseline|Total|Total of all reporting groups
221934|NCT01483625|B2|Baseline|Tiotropium 18mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
221935|NCT01483625|B1|Baseline|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
221936|NCT01483625|P2|Participant Flow|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
221937|NCT01483625|P1|Participant Flow|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
221938|NCT01483625|O2|Outcome|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
221939|NCT01483625|O1|Outcome|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
221940|NCT01483625|O2|Outcome|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
221941|NCT01483625|O1|Outcome|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
221942|NCT01483625|O2|Outcome|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
221943|NCT01483625|O1|Outcome|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
221944|NCT01483625|O2|Outcome|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
221945|NCT01483625|O1|Outcome|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
221946|NCT01483625|O2|Outcome|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
221947|NCT01483625|O1|Outcome|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
221948|NCT01483625|O2|Outcome|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
221949|NCT01483625|O1|Outcome|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
221950|NCT01483625|E2|Reported Event|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
221951|NCT01483625|E1|Reported Event|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
221952|NCT01483599|B8|Baseline|Total|Total of all reporting groups
221953|NCT01483599|B7|Baseline|Adalimumab|Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
221954|NCT01483599|B6|Baseline|CNTO1959 200 mg|Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
221955|NCT01483599|B5|Baseline|CNTO1959 100 mg|Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
221956|NCT01483599|B4|Baseline|CNTO1959 50 mg|Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
221957|NCT01483599|B3|Baseline|CNTO1959 15 mg|Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
221958|NCT01483599|B2|Baseline|CNTO1959 5 mg|Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
221959|NCT01483599|B1|Baseline|Placebo|Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4, Week 8 then 100 mg CNTO1959 at Week 16 and once every 8 weeks thereafter through Week 40.
221960|NCT01483599|P14|Participant Flow|Adalimumab (After CP)|Participants who received adalimumab and completed controlled period continued to receive adalimumab 40 mg starting at week 17 and every other week thereafter through Week 39.
221961|NCT01483599|P13|Participant Flow|CNTO1959 200 mg (After CP)|Participants who received CNTO1959 200 mg and completed controlled period continued to receive CNTO1959 200 mg starting at Week 16 and once in every 12 weeks through Week 40.
221962|NCT01483599|P12|Participant Flow|CNTO1959 100 mg (After CP)|Participants who received CNTO1959 100 mg and completed controlled period continued to receive CNTO1959 100 mg starting at Week 16 and once in every 8 weeks through Week 40.
225440|NCT01472939|O2|Outcome|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
221965|NCT01483599|P9|Participant Flow|CNTO1959 5 mg (After CP)|Participants who received CNTO1959 5 mg and completed controlled period continued to receive CNTO1959 5 mg starting at Week 16 and once in every 12 weeks through Week 40.
221966|NCT01483599|P8|Participant Flow|Placebo -> 100 mg CNTO1959 (After CP)|Same participants who received placebo and completed controlled period transitioned to receive 100 mg CNTO1959 at Week 16 and once in every 8 weeks through Week 40.
221967|NCT01483599|P7|Participant Flow|Adalimumab (CP)|Participants received Adalimumab 80 mg subcutaneous injection at Week 0 and 40 mg at Week 1 and every other week up to Week 15.
221968|NCT01483599|P6|Participant Flow|CNTO1959 200 mg (CP)|Participants received CNTO1959 200 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
221969|NCT01483599|P5|Participant Flow|CNTO1959 100 mg (CP)|Participants received CNTO1959 100 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4.
221970|NCT01483599|P4|Participant Flow|CNTO1959 50 mg (CP)|Participants received CNTO1959 50 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
221971|NCT01483599|P3|Participant Flow|CNTO1959 15 mg (CP)|Participants received CNTO1959 15 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4.
221972|NCT01483599|P2|Participant Flow|CNTO1959 5 mg (CP)|Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
221973|NCT01483599|P1|Participant Flow|Placebo (CP)|Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4 and Week 8.
221974|NCT01483599|O7|Outcome|Adalimumab|Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
221975|NCT01483599|O6|Outcome|CNTO1959 200 mg|Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
221976|NCT01483599|O5|Outcome|CNTO1959 100 mg|Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
221977|NCT01483599|O4|Outcome|CNTO1959 50 mg|Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
221978|NCT01483599|O3|Outcome|CNTO1959 15 mg|Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
221979|NCT01483599|O2|Outcome|CNTO1959 5 mg|Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
221980|NCT01483599|O1|Outcome|Placebo|Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4, Week 8 then 100 mg CNTO1959 at Week 16 and once every 8 weeks thereafter through Week 40.
221981|NCT01483599|O6|Outcome|Adalimumab|Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
221982|NCT01483599|O5|Outcome|CNTO1959 200 mg|Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
221983|NCT01483599|O4|Outcome|CNTO1959 100 mg|Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
221984|NCT01483599|O3|Outcome|CNTO1959 50 mg|Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
221985|NCT01483599|O2|Outcome|CNTO1959 15 mg|Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
221986|NCT01483599|O1|Outcome|CNTO1959 5 mg|Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
221987|NCT01483599|O6|Outcome|Adalimumab|Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
221988|NCT01483599|O5|Outcome|CNTO1959 200 mg|Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
221989|NCT01483599|O4|Outcome|CNTO1959 100 mg|Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
221990|NCT01483599|O3|Outcome|CNTO1959 50 mg|Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
221991|NCT01483599|O2|Outcome|CNTO1959 15 mg|Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
221992|NCT01483599|O1|Outcome|CNTO1959 5 mg|Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
221993|NCT01483599|O7|Outcome|Adalimumab|Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
221994|NCT01483599|O6|Outcome|CNTO1959 200 mg|Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
221995|NCT01483599|O5|Outcome|CNTO1959 100 mg|Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
221996|NCT01483599|O4|Outcome|CNTO1959 50 mg|Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
221997|NCT01483599|O3|Outcome|CNTO1959 15 mg|Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
221998|NCT01483599|O2|Outcome|CNTO1959 5 mg|Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
221999|NCT01483599|O1|Outcome|Placebo|Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4, Week 8 then 100 mg CNTO1959 at Week 16 and once every 8 weeks thereafter through Week 40.
222000|NCT01483599|O7|Outcome|Adalimumab|Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
222001|NCT01483599|O6|Outcome|CNTO1959 200 mg|Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
222002|NCT01483599|O5|Outcome|CNTO1959 100 mg|Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
222003|NCT01483599|O4|Outcome|CNTO1959 50 mg|Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
222004|NCT01483599|O3|Outcome|CNTO1959 15 mg|Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
222005|NCT01483599|O2|Outcome|CNTO1959 5 mg|Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
222006|NCT01483599|O1|Outcome|Placebo|Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4, Week 8 then 100 mg CNTO1959 at Week 16 and once every 8 weeks thereafter through Week 40.
222007|NCT01483599|E14|Reported Event|Adalimumab (After CP)|Participants who received adalimumab and completed controlled period continued to receive adalimumab 40 mg starting at week 17 and every other week thereafter through Week 39.
222008|NCT01483599|E13|Reported Event|CNTO1959 200 mg (After CP)|Participants who received CNTO1959 200 mg and completed controlled period continued to receive CNTO1959 200 mg starting at Week 16 and once in every 12 weeks through Week 40.
222009|NCT01483599|E12|Reported Event|CNTO1959 100 mg (After CP)|Participants who received CNTO1959 100 mg and completed controlled period continued to receive CNTO1959 100 mg starting at Week 16 and once in every 8 weeks through Week 40.
222010|NCT01483599|E11|Reported Event|CNTO1959 50 mg (After CP)|Participants who received CNTO1959 50 mg and completed controlled period continued to receive CNTO1959 50 mg starting at Week 16 and once in every 12 weeks through Week 40.
222011|NCT01483599|E10|Reported Event|CNTO1959 15 mg (After CP)|Participants who received CNTO1959 15 mg and completed controlled period continued to receive CNTO1959 15 mg starting at Week 16 and once in every 8 weeks through Week 40.
222012|NCT01483599|E9|Reported Event|CNTO1959 5 mg (After CP)|Participants who received CNTO1959 5 mg and completed controlled period continued to receive CNTO1959 5 mg starting at Week 16 and once in every 12 weeks through Week 40.
222013|NCT01483599|E8|Reported Event|Placebo -> 100 mg CNTO1959 (After CP)|Same participants who received placebo and completed controlled period transitioned to receive 100 mg CNTO1959 at Week 16 and once in every 8 weeks through Week 40.
222014|NCT01483599|E7|Reported Event|Adalimumab (CP)|Participants received Adalimumab 80 mg subcutaneous injection at Week 0 and 40 mg at Week 1 and every other week up to Week 15.
222015|NCT01483599|E6|Reported Event|CNTO1959 200 mg (CP)|Participants received CNTO1959 200 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
222016|NCT01483599|E5|Reported Event|CNTO1959 100 mg (CP)|Participants received CNTO1959 100 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4.
222017|NCT01483599|E4|Reported Event|CNTO1959 50 mg (CP)|Participants received CNTO1959 50 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
222018|NCT01483599|E3|Reported Event|CNTO1959 15 mg (CP)|Participants received CNTO1959 15 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4.
222019|NCT01483599|E2|Reported Event|CNTO1959 5 mg (CP)|Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
222020|NCT01483599|E1|Reported Event|Placebo (CP)|Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4 and Week 8.
222021|NCT01483378|B1|Baseline|Survey Participants|
222022|NCT01483378|P2|Participant Flow|Patients Who Declined the Herpes Zoster Vaccine|These eligible subjects completed the survey and then declined to receive the herpes zoster vaccine for free.
222023|NCT01483378|P1|Participant Flow|Patients Who Received the Herpes Zoster Vaccine|These eligible subjects completed the survey and then chose to receive the herpes zoster vaccine for free.
222024|NCT01483378|O2|Outcome|Patients Who Declined the Herpes Zoster Vaccine|Patients who declined to receive the herpes zoster vaccine completed the survey. Primary outcomes reported are statistically significant answers to the survey questions.
222025|NCT01483378|O1|Outcome|Patients Who Received the Herpes Zoster Vaccine|Patients who chose to receive the herpes zoster vaccine completed the survey. Primary outcomes reported are statistically significant answers to the survey questions.
222026|NCT01483378|E2|Reported Event|Subjects Who Declined the Herpes Zoster Vaccine|
222027|NCT01483378|E1|Reported Event|Subjects Who Received the Herpes Zoster Vaccine|
222028|NCT01483352|B1|Baseline|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
222029|NCT01483352|P1|Participant Flow|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
222030|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
222031|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
222032|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
222033|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
222034|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
222035|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
222036|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
222037|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
222038|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
222039|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
222040|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
222041|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
222042|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
222043|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
222044|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
222045|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
222046|NCT01483352|E1|Reported Event|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
222047|NCT01483209|B1|Baseline|Boxtox Injection|Subjects will serve as their own controls. Both hands are evaluated and the hand demonstrating more severe ischemia will be the one to receive the Botox (experimental treatment).
222048|NCT01483209|P1|Participant Flow|Boxtox Injection|Subjects will serve as their own controls. Both hands are evaluated and the hand demonstrating more severe ischemia will be the one to receive the Botox (experimental treatment).
222049|NCT01483209|O1|Outcome|Botox Injection|"Use of botulinum toxin A to determine efficacy in treating vasopressor-induced digital ischemia~Injection of botulinum toxin A: One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy"
222050|NCT01483209|O1|Outcome|Botox Injection|"Use of botulinum toxin A to determine efficacy in treating vasopressor-induced digital ischemia~Injection of botulinum toxin A: One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy"
222051|NCT01483209|E1|Reported Event|Botox Injection|"Use of botulinum toxin A to determine efficacy in treating vasopressor-induced digital ischemia~Injection of botulinum toxin A: One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy"
222052|NCT01483183|B11|Baseline|Total|Total of all reporting groups
222053|NCT01483183|B10|Baseline|Persistent AF - Placebo|Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
222054|NCT01483183|B9|Baseline|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222055|NCT01483183|B8|Baseline|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222056|NCT01483183|B7|Baseline|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222057|NCT01483183|B6|Baseline|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222058|NCT01483183|B5|Baseline|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222059|NCT01483183|B4|Baseline|Paroxysmal AF - Placebo|Participants had received placebo dose 10-minute constant rate IV infusion.
222060|NCT01483183|B3|Baseline|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222061|NCT01483183|B2|Baseline|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222062|NCT01483183|B1|Baseline|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222063|NCT01483183|P10|Participant Flow|Persistent AF - Placebo|Participants received a single dose of placebo, 10-minute constant rate IV infusion.
222064|NCT01483183|P9|Participant Flow|Persistent AF - OPC-108459 1.55 mg/kg|Participants received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222065|NCT01483183|P8|Participant Flow|Persistent AF - OPC-108459 1.35 mg/kg|Participants received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222066|NCT01483183|P7|Participant Flow|Persistent AF - OPC-108459 0.60 mg/kg|Participants received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222067|NCT01483183|P6|Participant Flow|Persistent AF - OPC-108459 0.40 mg/kg|Participants received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222068|NCT01483183|P5|Participant Flow|Persistent AF - OPC-108459 0.26 mg/kg|Participants received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222069|NCT01483183|P4|Participant Flow|Paroxysmal AF - Placebo|Participants received placebo dose 10-minute constant rate IV infusion.
222070|NCT01483183|P3|Participant Flow|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222071|NCT01483183|P2|Participant Flow|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222072|NCT01483183|P1|Participant Flow|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants received a single dose of OPC-108459 0.26 milligram per kilogram (mg/kg), 10-minute constant rate intravenous (IV) infusion to achieve specified Cmax target.
222073|NCT01483183|O10|Outcome|Persistent AF - Placebo|Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
222074|NCT01483183|O9|Outcome|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222075|NCT01483183|O8|Outcome|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222076|NCT01483183|O7|Outcome|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222077|NCT01483183|O6|Outcome|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222078|NCT01483183|O5|Outcome|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222079|NCT01483183|O4|Outcome|Paroxysmal AF - Placebo|Participants had received placebo dose 10-minute constant rate IV infusion.
222080|NCT01483183|O3|Outcome|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222081|NCT01483183|O2|Outcome|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222082|NCT01483183|O1|Outcome|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222083|NCT01483183|O10|Outcome|Persistent AF - Placebo|Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
222084|NCT01483183|O9|Outcome|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222085|NCT01483183|O8|Outcome|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222086|NCT01483183|O7|Outcome|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222087|NCT01483183|O6|Outcome|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222088|NCT01483183|O5|Outcome|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222089|NCT01483183|O4|Outcome|Paroxysmal AF - Placebo|Participants had received placebo dose 10-minute constant rate IV infusion.
222090|NCT01483183|O3|Outcome|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222091|NCT01483183|O2|Outcome|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222092|NCT01483183|O1|Outcome|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222093|NCT01483183|O10|Outcome|Persistent AF - Placebo|Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
222094|NCT01483183|O9|Outcome|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222095|NCT01483183|O8|Outcome|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222096|NCT01483183|O7|Outcome|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222097|NCT01483183|O6|Outcome|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222098|NCT01483183|O5|Outcome|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222099|NCT01483183|O4|Outcome|Paroxysmal AF - Placebo|Participants had received placebo dose 10-minute constant rate IV infusion.
222100|NCT01483183|O3|Outcome|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222101|NCT01483183|O2|Outcome|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222102|NCT01483183|O1|Outcome|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222103|NCT01483183|O10|Outcome|Persistent AF - Placebo|Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
222104|NCT01483183|O9|Outcome|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222105|NCT01483183|O8|Outcome|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222106|NCT01483183|O7|Outcome|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
246734|NCT01402115|O2|Outcome|Placebo|Placebo 15mg for 12 weeks
222107|NCT01483183|O6|Outcome|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222108|NCT01483183|O5|Outcome|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222109|NCT01483183|O4|Outcome|Paroxysmal AF - Placebo|Participants had received placebo dose 10-minute constant rate IV infusion.
222110|NCT01483183|O3|Outcome|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222111|NCT01483183|O2|Outcome|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222112|NCT01483183|O1|Outcome|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222113|NCT01483183|O8|Outcome|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222114|NCT01483183|O7|Outcome|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222115|NCT01483183|O6|Outcome|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222116|NCT01483183|O5|Outcome|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222117|NCT01483183|O4|Outcome|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222118|NCT01483183|O3|Outcome|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222119|NCT01483183|O2|Outcome|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222120|NCT01483183|O1|Outcome|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222121|NCT01483183|O8|Outcome|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222122|NCT01483183|O7|Outcome|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222123|NCT01483183|O6|Outcome|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222124|NCT01483183|O5|Outcome|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222125|NCT01483183|O4|Outcome|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222126|NCT01483183|O3|Outcome|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222127|NCT01483183|O2|Outcome|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222128|NCT01483183|O1|Outcome|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222129|NCT01483183|E10|Reported Event|Persistent AF - Placebo|Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
222130|NCT01483183|E9|Reported Event|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222131|NCT01483183|E8|Reported Event|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222132|NCT01483183|E7|Reported Event|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222133|NCT01483183|E6|Reported Event|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222134|NCT01483183|E5|Reported Event|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222135|NCT01483183|E4|Reported Event|Paroxysmal AF - Placebo|Participants had received placebo dose 10-minute constant rate IV infusion.
222136|NCT01483183|E3|Reported Event|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222137|NCT01483183|E2|Reported Event|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
222138|NCT01483183|E1|Reported Event|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
222139|NCT01483118|B3|Baseline|Total|Total of all reporting groups
222140|NCT01483118|B2|Baseline|Placebo Arm|"Placebo capsules containing ground cereal.~Placebo: Placebo capsules containing ground cereal."
222141|NCT01483118|B1|Baseline|Cinnamon Extract Arm|"Purified aqueous abstract of cinnamon in 125mg capsules~Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months."
222142|NCT01483118|P2|Participant Flow|Placebo Arm|"Placebo capsules containing ground cereal.~Placebo: Placebo capsules containing ground cereal."
222143|NCT01483118|P1|Participant Flow|Cinnamon Extract Arm|"Purified aqueous abstract of cinnamon in 125mg capsules~Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months."
222144|NCT01483118|O2|Outcome|Placebo Arm|"Placebo capsules containing ground cereal.~Placebo: Placebo capsules containing ground cereal.~Baseline (no. of cycles/month) 0.42 Study period (no. of cycles/month) 0.25 Change during study +/- cycles/month -0.13"
222145|NCT01483118|O1|Outcome|Cinnamon Extract Arm|"Purified aqueous abstract of cinnamon in 125mg capsules~Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months.~Baseline (no. of cycles/month) 0.42 Study period (no. of cycles/month) 0.75 Change during study +/- cycles/month +0.23"
222146|NCT01483118|O2|Outcome|Placebo Arm|"Placebo capsules containing ground cereal.~Placebo: Placebo capsules containing ground cereal."
222147|NCT01483118|O1|Outcome|Cinnamon Extract Arm|"Purified aqueous abstract of cinnamon in 125mg capsules~Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months."
222148|NCT01483118|O2|Outcome|Placebo Arm|"Placebo capsules containing ground cereal.~Placebo: Placebo capsules containing ground cereal.~Baseline (no. of cycles/month) 0.42 Study period (no. of cycles/month) 0.25 Change during study +/- cycles/month -0.13"
222149|NCT01483118|O1|Outcome|Cinnamon Extract Arm|"Purified aqueous abstract of cinnamon in 125mg capsules~Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months.~Baseline (no. of cycles/month) 0.42 Study period (no. of cycles/month) 0.75 Change during study +/- cycles/month +0.23"
222150|NCT01483118|E2|Reported Event|Placebo Arm|"PCOS patients receiving placebo capsules~Placebo: Placebo capsules containing ground cereal."
222151|NCT01483118|E1|Reported Event|Cinnamon Extract Arm|"PCOS patients receiving extract of cinnamon~Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months."
222152|NCT01482910|B3|Baseline|Total|Total of all reporting groups
222153|NCT01482910|B2|Baseline|PDT Treatments|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
222154|NCT01482910|B1|Baseline|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
222155|NCT01482910|P2|Participant Flow|PDT Treatments|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
222156|NCT01482910|P1|Participant Flow|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
222157|NCT01482910|O2|Outcome|PDT Treatments|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
222158|NCT01482910|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
222159|NCT01482910|O2|Outcome|PDT Treatments|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
222160|NCT01482910|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
222161|NCT01482910|E4|Reported Event|PDT Then Aflibercept Injection, From Week 28 to Week 52|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48. The data from week 28 up to week 52 was reported.
222162|NCT01482910|E3|Reported Event|Aflibercept Injection, From Week 28 to Week 52|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed. The data from week 28 up to week 52 was reported.
222163|NCT01482910|E2|Reported Event|PDT Treatments, up to Week 28|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48. The data up to week 28 was reported.
222164|NCT01482910|E1|Reported Event|Aflibercept Injection, up to Week 28|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed. The data up to week 28 was reported.
222165|NCT01482884|B3|Baseline|Total|Total of all reporting groups
222166|NCT01482884|B2|Baseline|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
222167|NCT01482884|B1|Baseline|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
222168|NCT01482884|P2|Participant Flow|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
222169|NCT01482884|P1|Participant Flow|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
222170|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
222171|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
222172|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
222173|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
222174|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
222175|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
222176|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
222177|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
222178|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
222179|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
222180|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
222181|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
222182|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
222183|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
222184|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
222185|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
222186|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
222187|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
222188|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
222189|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
222190|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
222191|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
222192|NCT01482884|E2|Reported Event|Tralokinumab 300 mg|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
222193|NCT01482884|E1|Reported Event|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
222194|NCT01482819|B1|Baseline|All Subjects|Twenty-one subjects were enrolled, and 19 subjects completed the study per protocol. Two subjects were discontinued. There were no ineligible subjects.
222195|NCT01482819|P1|Participant Flow|All Subjects|Twenty-one subjects were enrolled, and 19 subjects completed the study per protocol. Two subjects were discontinued. There were no ineligible subjects.
222196|NCT01482819|O5|Outcome|Polymacon|test article
222197|NCT01482819|O4|Outcome|Lotrafilcon A|test article
222198|NCT01482819|O3|Outcome|Galyfilcon A|test article
222199|NCT01482819|O2|Outcome|Galyfilcon A Plus|Test article
222200|NCT01482819|O1|Outcome|Spectacles|No lenses, glasses wear only, testing is done on open eye once glasses are removed. Acted as a negative control.
222201|NCT01482819|O5|Outcome|Polymacon|test article
222202|NCT01482819|O4|Outcome|Lotrafilcon A|test article
222203|NCT01482819|O3|Outcome|Galyfilcon A|test article
222204|NCT01482819|O2|Outcome|Galyfilcon A Plus|Test article
222205|NCT01482819|O1|Outcome|Spectacles|No lenses, glasses wear only, testing is done on open eye once glasses are removed. Acted as a negative control.
222206|NCT01482819|O5|Outcome|Polymacon|test article
222207|NCT01482819|O4|Outcome|Lotrafilcon A|test article
222208|NCT01482819|O3|Outcome|Galyfilcon A|test article
222209|NCT01482819|O2|Outcome|Galyfilcon A Plus|Test article
222210|NCT01482819|O1|Outcome|Spectacles|No lenses, glasses wear only, testing is done on open eye once glasses are removed. Acted as a negative control.
222211|NCT01482819|E1|Reported Event|All Subjects|Twenty-one subjects were enrolled, and 19 subjects completed the study per protocol. Two subjects were discontinued. There were no ineligible subjects.
222212|NCT01482767|B3|Baseline|Total|Total of all reporting groups
222213|NCT01482767|B2|Baseline|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
222214|NCT01482767|B1|Baseline|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
222215|NCT01482767|P2|Participant Flow|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
222216|NCT01482767|P1|Participant Flow|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
222217|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
222218|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
222219|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
222220|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
222221|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
222222|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
222223|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
222224|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
222225|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
222226|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
222227|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
222228|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
222229|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
222230|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
222231|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
222261|NCT01482312|E2|Reported Event|Comfilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
222443|NCT01481740|O2|Outcome|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
222232|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
222233|NCT01482767|E2|Reported Event|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
222234|NCT01482767|E1|Reported Event|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
222235|NCT01482429|B3|Baseline|Total|Total of all reporting groups
222236|NCT01482429|B2|Baseline|Usual Care|Discontinuation of ventilation was left entirely to the discretion of the physicians.
222237|NCT01482429|B1|Baseline|Protocol-directed|Discontinuation of ventilation was based in multidisciplinary protocol.
222238|NCT01482429|P2|Participant Flow|Usual Care|Discontinuation of ventilation was left entirely to the discretion of the physicians.
222239|NCT01482429|P1|Participant Flow|Protocol-directed|Discontinuation of ventilation was based in multidisciplinary protocol.
222240|NCT01482429|O2|Outcome|Usual Care|Discontinuation of ventilation was left entirely to the discretion of the physicians.
222241|NCT01482429|O1|Outcome|Protocol-directed|Discontinuation of ventilation was based in multidisciplinary protocol.
222242|NCT01482429|O2|Outcome|Usual Care|Discontinuation of ventilation was left entirely to the discretion of the physicians.
222243|NCT01482429|O1|Outcome|Protocol-directed|Discontinuation of ventilation was based in multidisciplinary protocol.
222244|NCT01482429|E2|Reported Event|Usual Care|Discontinuation of ventilation was left entirely to the discretion of the physicians.
222245|NCT01482429|E1|Reported Event|Protocol-directed|Discontinuation of ventilation was based in multidisciplinary protocol.
222246|NCT01482325|B1|Baseline|Subjects Requiring Blood Pressure Monitoring|"Any subject (neonate-adult) requiring hospital or clinic blood pressure monitoring~Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor: 10-20 Non-Invasive Blood Pressure readings on investigational software in the DASH2500 Patient Monitor"
222247|NCT01482325|P1|Participant Flow|Subjects Requiring Blood Pressure Monitoring|"St. Joseph’s Hospital (001), there were 21 subjects screened, of which five were screen failures and 16 subjects completed the study. Wisconsin Heart Hospital (002), there were 25 subjects screened, of which 10 were screen failures and 15 subjects completed the study.~There were enrollment criteria followed by both Site 001 and Site 002 that were provided by the study’s GEHC engineer in order to test the SuperSTAT algorithm. Each set of subjects enrolled under the required enrollment criteria were tested by the GEHC engineer."
222248|NCT01482325|O1|Outcome|Subjects Requiring Blood Pressure Monitoring|"St. Joseph’s Hospital (001), there were 21 subjects screened, of which five were screen failures and 16 subjects completed the study. Wisconsin Heart Hospital (002), there were 25 subjects screened, of which 10 were screen failures and 15 subjects completed the study.~There were enrollment criteria followed by both Site 001 and Site 002 that were provided by the study’s GEHC engineer in order to test the SuperSTAT algorithm. Each set of subjects enrolled under the required enrollment criteria were tested by the GEHC engineer."
222249|NCT01482325|E1|Reported Event|Subjects Requiring Blood Pressure Monitoring|"Any subject (neonate-adult) requiring hospital or clinic blood pressure monitoring~Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor: 10-20 Non-Invasive Blood Pressure readings on investigational software in the DASH2500 Patient Monitor~At Site #001 – St. Joseph’s Hospital, there were 21 subjects screened, of which five were screen failures and 16 subjects completed the study. There were no adverse events reported.~At Site #002 – Wisconsin Heart Hospital, there were 25 subjects screened, of which 10 were screen failures and 15 subjects completed the study. There were no adverse events reported."
222250|NCT01482312|B1|Baseline|Overall|This reporting group includes all enrolled participants.
222251|NCT01482312|P3|Participant Flow|Glasses / Lotrafilcon A / Comfilcon A|Glasses worn first, followed by lotrafilcon A contact lenses, followed by comfilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
222252|NCT01482312|P2|Participant Flow|Comfilcon A / Glasses / Lotrafilcon A|Comfilcon A contact lenses worn first, followed by glasses, followed by lotrafilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
222253|NCT01482312|P1|Participant Flow|Lotrafilcon A / Comfilcon A / Glasses|Lotrafilcon A contact lenses worn first, followed by comfilcon A contact lenses, followed by habitual glasses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
222254|NCT01482312|O3|Outcome|Glasses|Glasses per habitual prescription
222255|NCT01482312|O2|Outcome|Comfilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
222256|NCT01482312|O1|Outcome|Lotrafilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
222257|NCT01482312|O3|Outcome|Glasses|Glasses per habitual prescription
222258|NCT01482312|O2|Outcome|Comfilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
222259|NCT01482312|O1|Outcome|Lotrafilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
222260|NCT01482312|E3|Reported Event|Glasses|Glasses per habitual prescription
222262|NCT01482312|E1|Reported Event|Lotrafilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
222263|NCT01482221|B4|Baseline|Total|Total of all reporting groups
222264|NCT01482221|B3|Baseline|Placebo|Intravenous infusion
222265|NCT01482221|B2|Baseline|AZD6765 100 mg|Intravenous infusion
222266|NCT01482221|B1|Baseline|AZD6765 50 mg|Intravenous infusion
222267|NCT01482221|P3|Participant Flow|Placebo|Intravenous infusion
222268|NCT01482221|P2|Participant Flow|AZD6765 100 mg|Intravenous infusion
222269|NCT01482221|P1|Participant Flow|AZD6765 50 mg|Intravenous infusion
222270|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
222271|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
222272|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
222273|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
222274|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
222275|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
222276|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
222277|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
222278|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
222279|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
222280|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
222281|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
222282|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
222283|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
222284|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
222285|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
222286|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
222287|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
222288|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
222289|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
222290|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
222291|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
222292|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
222293|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
222294|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
222295|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
222296|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
222297|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
222298|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
222299|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
222300|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
222301|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
222302|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
222303|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
222304|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
222305|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
222306|NCT01482221|E3|Reported Event|Placebo|Intravenous infusion
222307|NCT01482221|E2|Reported Event|AZD6765iv 50 mg|Intravenous infusion
222308|NCT01482221|E1|Reported Event|AZD6765iv 100 mg|Intravenous infusion
222309|NCT01482169|B1|Baseline|Adenoscan + Regadenoson|"Subjects will have the FFR Measurement with IV Adenoscan® then with Regadenoson~FFR Measurement with IV Adenoscan® then with Regadenoson: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive an initial infusion of IV Adenoscan® through a peripheral vein at 140 mcg/kg/min. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved. It takes about 84 seconds to reach peak hyperemia with Adenoscan®. Subsequently, these subjects will receive a dose of regadenoson at 0.4 mg through the same peripheral access site. FFR measurements will be obtained once peak hyperemia is achieved, which takes less than 30 seconds with regadenoson. Patients who react to either medication will be supported conservatively under close scrutiny."
222310|NCT01482169|P1|Participant Flow|Adenoscan + Regadenoson|"Subjects will have the FFR Measurement with IV Adenoscan® then with Regadenoson~FFR Measurement with IV Adenoscan® then with Regadenoson: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive an initial infusion of IV Adenoscan® through a peripheral vein at 140 mcg/kg/min. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved. It takes about 84 seconds to reach peak hyperemia with Adenoscan®. Subsequently, these subjects will receive a dose of regadenoson at 0.4 mg through the same peripheral access site. FFR measurements will be obtained once peak hyperemia is achieved, which takes less than 30 seconds with regadenoson. Patients who react to either medication will be supported conservatively under close scrutiny."
222311|NCT01482169|O1|Outcome|Duration to Baseline Hyperemia After Aminophylline Administrat|After subjects have the FFR measurement with Regadenoson, they will be administered aminophylline 150mg IV and the time duration to reach baseline hyperemia will be recorded.
222312|NCT01482169|O2|Outcome|Regadenoson|"Subjects will have the FFR Measurement with IV Regadenson~FFR Measurement with IV Regadenson: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive IV Regadenson through a peripheral vein. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved."
222313|NCT01482169|O1|Outcome|Adenoscan|"Subjects will have the FFR Measurement with IV Adenoscan®~FFR Measurement with IV Adenoscan®: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive an initial infusion of IV Adenoscan® through a peripheral vein at 140 mcg/kg/min. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved. It takes about 84 seconds to reach peak hyperemia with Adenoscan®."
222314|NCT01482169|E2|Reported Event|Regadenson|"Subjects will have the FFR Measurement with IV Regadenson~FFR Measurement with IV Regadenson: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive IV Regadenson through a peripheral vein. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved."
222315|NCT01482169|E1|Reported Event|Adenoscan|"Subjects will have the FFR Measurement with IV Adenoscan®~FFR Measurement with IV Adenoscan®: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive an initial infusion of IV Adenoscan® through a peripheral vein at 140 mcg/kg/min. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved. It takes about 84 seconds to reach peak hyperemia with Adenoscan®."
222316|NCT01482091|B3|Baseline|Total|Total of all reporting groups
222317|NCT01482091|B2|Baseline|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
222318|NCT01482091|B1|Baseline|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
222319|NCT01482091|P2|Participant Flow|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
222320|NCT01482091|P1|Participant Flow|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
222321|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
222322|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
222323|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
222324|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
222325|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
222326|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
222327|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
222328|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
222329|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
222330|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
222331|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
222332|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
222333|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
222334|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
222335|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
222336|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
222337|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
222338|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
222339|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
222340|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
222341|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
222342|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
222343|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
222344|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
222345|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
222346|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
222347|NCT01482091|E2|Reported Event|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
222348|NCT01482091|E1|Reported Event|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
222349|NCT01482065|B3|Baseline|Total|Total of all reporting groups
222350|NCT01482065|B2|Baseline|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
222351|NCT01482065|B1|Baseline|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.~CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
222352|NCT01482065|P2|Participant Flow|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
222353|NCT01482065|P1|Participant Flow|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.~Criteria for Obstructive Sleep Apnea (OSA) severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.~CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
222354|NCT01482065|O2|Outcome|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
222378|NCT01481896|O1|Outcome|Stem Stability|"Based on the most recent follow-up x-ray, the fixation of the stem component implanted in a patient's femur was graded as bone ingrown, fibrous stable or loose using the criteria defined by Engh, Massin and Suthers in their article titled Roentgenographic assessment of the biologic fixation of porous-surfaced femoral components published in the August 1990 edition of Clinical Orthopaedics and Related Research on pages 107 to 128."
222444|NCT01481740|O1|Outcome|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
222445|NCT01481740|O2|Outcome|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
222355|NCT01482065|O1|Outcome|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.~Criteria for Obstructive Sleep Apnea (OSA) severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.~CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
222356|NCT01482065|O2|Outcome|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
222357|NCT01482065|O1|Outcome|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.~Criteria for Obstructive Sleep Apnea (OSA) severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.~CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
222358|NCT01482065|O2|Outcome|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
222359|NCT01482065|O1|Outcome|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.~Criteria for Obstructive Sleep Apnea (OSA) severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.~CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
222360|NCT01482065|O2|Outcome|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
222361|NCT01482065|O1|Outcome|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.~Criteria for Obstructive Sleep Apnea (OSA) severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.~CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
222362|NCT01482065|E2|Reported Event|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
222379|NCT01481896|O2|Outcome|Hips With CT Scans Analyzed for Pelvic Osteolysis|Digital Computed Tomography (CT) scans taken more than 5 years after a patient's hip replacement were used to evaluate pelvic bone loss (osteolysis). Regions of bone loss were traced on CT slices to determine the volume and location of each osteolytic defect using three-dimensional image analysis software (Analyze, Biomedical Imaging Resource, Rochester, MN). For the purposes of reporting, the total number of hips with any evidence of pelvic osteolysis on CT is indicated.
222363|NCT01482065|E1|Reported Event|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.~CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
222364|NCT01481935|B3|Baseline|Total|Total of all reporting groups
222365|NCT01481935|B2|Baseline|Sham Enhanced Cleaning|Rooms in the Sham Enhanced Cleaning arm received a single sham extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Sham Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
222366|NCT01481935|B1|Baseline|Enhanced Cleaning|Rooms in the Enhanced Cleaning arm received a single extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
222367|NCT01481935|P2|Participant Flow|Enhanced Cleaning|Rooms in the Enhanced Cleaning arm received a single extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
222368|NCT01481935|P1|Participant Flow|Sham Enhanced Cleaning|Rooms in the Sham Enhanced Cleaning arm received a single sham extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Sham Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
222369|NCT01481935|O2|Outcome|Enhanced Cleaning|Rooms in the Enhanced Cleaning arm received a single extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
222370|NCT01481935|O1|Outcome|Sham Enhanced Cleaning|Rooms in the Sham Enhanced Cleaning arm received a single sham extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Sham Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
222371|NCT01481935|E2|Reported Event|Enhanced Cleaning|Rooms in the Enhanced Cleaning arm received a single extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
222372|NCT01481935|E1|Reported Event|Sham Enhanced Cleaning|Rooms in the Sham Enhanced Cleaning arm received a single sham extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Sham Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
222373|NCT01481896|B1|Baseline|Metal-on-Metal Total Hip Arthroplasties|Consecutive series of primary total hip arthroplasties performed with DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads.
222374|NCT01481896|P1|Participant Flow|Metal-on-Metal Total Hip Arthroplasties|Consecutive series of primary total hip arthroplasties performed with DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads.
222375|NCT01481896|O1|Outcome|Patients Satisfied With Outcome of Hip Replacement|"Patient satisfaction was evaluated by asking the question, Are you satisfied with the results of your hip operation? on a questionnaire. Patients could respond Yes or No by filling in the appropriated bubble on the questionnaire."
222376|NCT01481896|O1|Outcome|Metal-on-Metal Total Hip Arthroplasties|Consecutive series of primary total hip arthroplasties performed with DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads.
222377|NCT01481896|O2|Outcome|Cup Stability|Based on the most recent follow-up x-ray, the fixation of the cup component implanted in a patient's pelvis was graded as bone ingrown, fibrous stable or loose. A cup was considered fibrous stable if there was a continuous radiolucent line along the interface between the cup and the patient's pelvic bone. A cup was considered loose if it had migrated more than 2 mm or its orientation had changed by at least 5 degrees on the follow-up x-ray compared to the immediate post-operative x-ray. A cup that did not meet the criteria for fibrous stable or loose was considered bone ingrown.
246735|NCT01402115|O1|Outcome|Polycan|Polycan 150mg for 12 weeks
222380|NCT01481896|O1|Outcome|Hips With Radiographs Analyzed for Femoral Osteolysis|Serial x-rays for each hip replacement were analyzed by a single experienced reviewer to identify regions where bone had been lost in the femur. Expansile (ballooned-out) regions of bone loss identified on follow-up x-rays taken at least 4.75 years after their surgery that were not apparent on the immediate post-operative x-ray were considered to be osteolysis. For the purposes of reporting, the total number of hips with any evidence of femoral osteolysis on x-ray is indicated.
222381|NCT01481896|O1|Outcome|Hips With Harris Hip Scores|The Harris Hip Score is an outcome measure used for hip replacements that ranges from 0 (worst) to 100 (best). The score consists of a series of questions related to hip pain, function and range of motion that accumulate a different number of points depending on the response choices. At the time of their follow-up visits, patients completed a standardized questionnaire that included components of the Harris Hip Score and the physician completed a standardized evaluation which included range of motion assessment.
222382|NCT01481896|O2|Outcome|Cup Anteversion Angle|The Cup Anteversion Angle quantifies the front-to-back rotation of the hemispheric implant implanted inside a patient's pelvis to replace their hip socket. When an anterioposterior (front-to-back) x-ray is taken, the circular face of the cup projects onto the x-ray as an ellipse. The ratio of the major axis of the ellipse to the minor axis can be used to calculate the anteversion. A cup rotated anteriorly has positive anteversion. A cup rotated posteriorly has negative anteversion. For this study, the cup Anteversion Angle was measured from digitized x-rays using Dr. John Martell's Hip Suite Analysis Software (University of Chicago, Chicago, IL). Taken together, the abduction and anteversion angle quantify the three-dimensional orientation of the cup.
222383|NCT01481896|O1|Outcome|Cup Abduction Angle|The Cup Abduction Angle quantifies the amount of tilt associated with the hemispheric implant implanted inside a patient's pelvis to replace their hip socket. When an anterioposterior (front-to-back) x-ray is taken, the angle between the face of the cup and a horizontal line defines the Cup Abduction Angle. The line defining the face of the cup is drawn through the uppermost and lowest edges of the cup's projection on the x-ray. For this study, the Cup Abduction Angle was measured from digitized x-rays using Dr. John Martell's Hip Suite Analysis Software (University of Chicago, Chicago, IL).
222384|NCT01481896|O2|Outcome|Patients With Serum Chromium Levels|Patients were recommended to have blood drawn for evaluation of serum chromium levels if they were considered to be active or thought to be at risk for an adverse local tissue reaction. Blood was drawn at our hospital or a facility of the patient's choice. The chromium detection limit was 0.1 micrograms per liter for all labs that performed metal level assessments. Patients with undetectable chromium levels were assigned a value of zero. A patient's chromium level was considered high if it was 7 micrograms per liter or greater.
222385|NCT01481896|O1|Outcome|Patients With Serum Cobalt Levels|Patients were recommended to have blood drawn for evaluation of serum cobalt levels if they were considered to be active or thought to be at risk for an adverse local tissue reaction. Blood was drawn at our hospital or a facility of the patient's choice. Among all the labs that performed metal level assessments, the cobalt detection limit varied from 0.5 to 1.0 microgram per liter. Patients with undetectable cobalt levels were assigned a value of zero. A patient's cobalt level was considered high if it was 7 micrograms per liter or greater.
222386|NCT01481896|E1|Reported Event|Metal-on-Metal Total Hip Arthroplasties|Consecutive series of primary total hip arthroplasties performed with DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads.
222387|NCT01481779|B3|Baseline|Total|Total of all reporting groups
222388|NCT01481779|B2|Baseline|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222389|NCT01481779|B1|Baseline|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222390|NCT01481779|P2|Participant Flow|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222391|NCT01481779|P1|Participant Flow|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by subcutaneous (SC) injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222392|NCT01481779|O2|Outcome|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222393|NCT01481779|O1|Outcome|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222394|NCT01481779|O2|Outcome|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222395|NCT01481779|O1|Outcome|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222396|NCT01481779|O2|Outcome|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222440|NCT01481740|P1|Participant Flow|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
222397|NCT01481779|O1|Outcome|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222398|NCT01481779|O2|Outcome|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222399|NCT01481779|O1|Outcome|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222400|NCT01481779|O2|Outcome|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222401|NCT01481779|O1|Outcome|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222402|NCT01481779|O2|Outcome|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222403|NCT01481779|O1|Outcome|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222404|NCT01481779|O2|Outcome|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222405|NCT01481779|O1|Outcome|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222406|NCT01481779|O2|Outcome|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222407|NCT01481779|O1|Outcome|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222408|NCT01481779|O2|Outcome|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222409|NCT01481779|O1|Outcome|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222410|NCT01481779|O2|Outcome|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222411|NCT01481779|O1|Outcome|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222412|NCT01481779|O2|Outcome|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222413|NCT01481779|O1|Outcome|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222414|NCT01481779|O2|Outcome|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222415|NCT01481779|O1|Outcome|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222416|NCT01481779|O2|Outcome|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222441|NCT01481740|O2|Outcome|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
222442|NCT01481740|O1|Outcome|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
222417|NCT01481779|O1|Outcome|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222418|NCT01481779|O2|Outcome|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222419|NCT01481779|O1|Outcome|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222420|NCT01481779|O2|Outcome|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222421|NCT01481779|O1|Outcome|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222422|NCT01481779|O2|Outcome|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222423|NCT01481779|O1|Outcome|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222424|NCT01481779|O2|Outcome|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222425|NCT01481779|O1|Outcome|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222426|NCT01481779|O2|Outcome|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222427|NCT01481779|O1|Outcome|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222428|NCT01481779|O2|Outcome|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222429|NCT01481779|O1|Outcome|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222430|NCT01481779|O2|Outcome|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222431|NCT01481779|O1|Outcome|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222432|NCT01481779|O2|Outcome|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222433|NCT01481779|O1|Outcome|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222434|NCT01481779|E2|Reported Event|Glargine + Insulin Lispro|Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
222435|NCT01481779|E1|Reported Event|LY2605541 + Insulin Lispro|LY2605541 titrated based on blood glucose readings, administered by subcutaneous (SC) injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered subcutaneously via pen device at meal times for 78 weeks.
222436|NCT01481740|B3|Baseline|Total|Total of all reporting groups
222437|NCT01481740|B2|Baseline|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
222438|NCT01481740|B1|Baseline|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
222439|NCT01481740|P2|Participant Flow|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
246736|NCT01402115|E2|Reported Event|Placebo|Placebo 15mg for 12 weeks
222446|NCT01481740|O1|Outcome|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
222447|NCT01481740|O2|Outcome|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
222448|NCT01481740|O1|Outcome|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
222449|NCT01481740|O2|Outcome|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
222450|NCT01481740|O1|Outcome|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
222451|NCT01481740|O2|Outcome|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
222452|NCT01481740|O1|Outcome|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
222453|NCT01481740|E2|Reported Event|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
222454|NCT01481740|E1|Reported Event|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
222455|NCT01481558|B3|Baseline|Total|Total of all reporting groups
222456|NCT01481558|B2|Baseline|Transcranial Direct Current Stimulation|One application of tDCS every two days (total: 6 applications)
222457|NCT01481558|B1|Baseline|Sham Transcranial Direct Current Stimulation|One application of sham tDCS every two days (total: 6 applications)
222458|NCT01481558|P2|Participant Flow|Transcranial Direct Current Stimulation|One application of tDCS every two days (total: 6 applications)
222459|NCT01481558|P1|Participant Flow|Sham Transcranial Direct Current Stimulation|One application of sham tDCS every two days (total: 6 applications)
222460|NCT01481558|O2|Outcome|Transcranial Direct Current Stimulation|One application of tDCS every two days (total: 6 applications)
222461|NCT01481558|O1|Outcome|Sham Transcranial Direct Current Stimulation|One application of sham tDCS every two days (total: 6 applications)
222462|NCT01481558|E2|Reported Event|Transcranial Direct Current Stimulation|One application of tDCS every two days (total: 6 applications)
222463|NCT01481558|E1|Reported Event|Sham Transcranial Direct Current Stimulation|One application of sham tDCS every two days (total: 6 applications)
222464|NCT01481376|B1|Baseline|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
222465|NCT01481376|P1|Participant Flow|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
222466|NCT01481376|O1|Outcome|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
222467|NCT01481376|O1|Outcome|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
222468|NCT01481376|O1|Outcome|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
222469|NCT01481376|O1|Outcome|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
222470|NCT01481376|O1|Outcome|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
222471|NCT01481376|E1|Reported Event|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
222472|NCT01481324|B4|Baseline|Total|Total of all reporting groups
222473|NCT01481324|B3|Baseline|No Sensor Group|This group will not have a pressure sensor placed on the foot ankle orthosis.
222474|NCT01481324|B2|Baseline|Non-Functioning Pressure Sensor Group|This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
222475|NCT01481324|B1|Baseline|Functioning Pressure Sensor Group|This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
222476|NCT01481324|P3|Participant Flow|No Sensor Group|This group will not have a pressure sensor placed on the foot ankle orthosis.
222477|NCT01481324|P2|Participant Flow|Non-Functioning Pressure Sensor Group|This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
222478|NCT01481324|P1|Participant Flow|Functioning Pressure Sensor Group|This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
222479|NCT01481324|O3|Outcome|No Sensor Group|This group will not have a pressure sensor placed on the foot ankle orthosis.
222480|NCT01481324|O2|Outcome|Non-Functioning Pressure Sensor Group|This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
222481|NCT01481324|O1|Outcome|Functioning Pressure Sensor Group|This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
222482|NCT01481324|E3|Reported Event|No Sensor Group|This group will not have a pressure sensor placed on the foot ankle orthosis.
222483|NCT01481324|E2|Reported Event|Non-Functioning Pressure Sensor Group|This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
222484|NCT01481324|E1|Reported Event|Functioning Pressure Sensor Group|This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
222485|NCT01481129|B1|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
222821|NCT01479764|B2|Baseline|Neostigmine/Glycopyrrolate|Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
222486|NCT01481129|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
222487|NCT01481129|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
222488|NCT01481129|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
222489|NCT01481129|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
222490|NCT01481129|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
222491|NCT01481129|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
222492|NCT01481129|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
222493|NCT01481116|B4|Baseline|Total|Total of all reporting groups
222494|NCT01481116|B3|Baseline|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
222495|NCT01481116|B2|Baseline|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
222496|NCT01481116|B1|Baseline|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
222497|NCT01481116|P3|Participant Flow|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
222498|NCT01481116|P2|Participant Flow|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
222499|NCT01481116|P1|Participant Flow|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
222500|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
222501|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
222502|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
222503|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
222504|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
222505|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
222506|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
222507|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
222531|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
246737|NCT01402115|E1|Reported Event|Polycan|Polycan 150mg for 12 weeks
222508|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
222509|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
222510|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
222511|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
222512|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
222513|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
222514|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
222515|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
222516|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
222517|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
222518|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
222519|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
222520|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
222521|NCT01481116|E3|Reported Event|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
222522|NCT01481116|E2|Reported Event|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
222523|NCT01481116|E1|Reported Event|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
222524|NCT01480843|B1|Baseline|Glargine|"We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients.~Glargine: Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults"
222525|NCT01480843|P1|Participant Flow|Glargine|"We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients.~Glargine: Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults"
222526|NCT01480843|O1|Outcome|Glargine|"We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients.~Glargine: Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults"
222527|NCT01480843|O1|Outcome|Glargine|"We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients.~Glargine: Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults"
222528|NCT01480843|E1|Reported Event|Glargine|"We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients.~Glargine: Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults"
222529|NCT01480674|B1|Baseline|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
222530|NCT01480674|P1|Participant Flow|Trastuzumab|Eligible participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab (Herceptin) as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
222532|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
222533|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
222534|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
222535|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
222536|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
222537|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
222538|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
222539|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
222540|NCT01480674|E1|Reported Event|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
222541|NCT01480596|B3|Baseline|Total|Total of all reporting groups
222542|NCT01480596|B2|Baseline|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222543|NCT01480596|B1|Baseline|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222544|NCT01480596|P2|Participant Flow|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222545|NCT01480596|P1|Participant Flow|Placebo IV|Participants received 250 milliliter (ml) of a normal saline placebo administered as intravenous (IV) infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222546|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222547|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222548|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222549|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222550|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222551|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222552|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222553|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222554|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222555|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
246738|NCT01402102|B3|Baseline|Total|Total of all reporting groups
222556|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222557|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222558|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222559|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222560|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222561|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222562|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222563|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222564|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222565|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222566|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222567|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222568|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222569|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222570|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222571|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222572|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222573|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222574|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222575|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222576|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222577|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222578|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222620|NCT01480284|E1|Reported Event|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
222579|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222580|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222581|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222582|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222583|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222584|NCT01480596|E2|Reported Event|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222585|NCT01480596|E1|Reported Event|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
222586|NCT01480297|B1|Baseline|Salsalate|"All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner).~Salsalate: Salsalate 3 grams daily (1 gram TID with meals)"
222587|NCT01480297|P1|Participant Flow|Salsalate|"All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner).~Salsalate: Salsalate 3 grams daily (1 gram TID with meals)"
222588|NCT01480297|O1|Outcome|Salsalate|"All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner).~Salsalate: Salsalate 3 grams daily (1 gram TID with meals)"
222589|NCT01480297|E1|Reported Event|Salsalate|"All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner).~Salsalate: Salsalate 3 grams daily (1 gram TID with meals)"
222590|NCT01480284|B3|Baseline|Total|Total of all reporting groups
222591|NCT01480284|B2|Baseline|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
222592|NCT01480284|B1|Baseline|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
222593|NCT01480284|P2|Participant Flow|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
222594|NCT01480284|P1|Participant Flow|TDF 300 mg OD|Participants received Tenofovir Disoproxil Fumarate (TDF) 300 milligrams (mg) tablet once daily (OD) and Entecavir Hydrate (ETV) placebo capsule OD for 96 weeks.
222595|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
222596|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
222597|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
222598|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
222599|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
222600|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
222601|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
222602|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
222603|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
222604|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
222605|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
222606|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
222607|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
222608|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
222609|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
222610|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
222611|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
222612|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
222613|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
222614|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
222615|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
222616|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
222617|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
222618|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
222619|NCT01480284|E2|Reported Event|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
222622|NCT01480232|B4|Baseline|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222623|NCT01480232|B3|Baseline|Placebo + NicoDerm (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222624|NCT01480232|B2|Baseline|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222625|NCT01480232|B1|Baseline|EVP-6124 + NicoDerm (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222626|NCT01480232|P4|Participant Flow|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222627|NCT01480232|P3|Participant Flow|Placebo + NicoDerm (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222628|NCT01480232|P2|Participant Flow|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NRT (nicotine replacement therapy) Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222629|NCT01480232|P1|Participant Flow|EVP-6124 + NicoDerm (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222630|NCT01480232|O4|Outcome|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222631|NCT01480232|O3|Outcome|Placebo + NicoDerm CQ (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222632|NCT01480232|O2|Outcome|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222633|NCT01480232|O1|Outcome|EVP-6124 + NicoDerm CQ (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222667|NCT01480089|P1|Participant Flow|Atomized Intraperitoneal Saline (AIS)|Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
222977|NCT01479543|O2|Outcome|Group B|"Volunteers receive Probiotic CNCM I-4035.~Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days."
222634|NCT01480232|O4|Outcome|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222635|NCT01480232|O3|Outcome|Placebo + NicoDerm CQ (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222636|NCT01480232|O2|Outcome|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222637|NCT01480232|O1|Outcome|EVP-6124 + NicoDerm CQ (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222638|NCT01480232|O4|Outcome|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222639|NCT01480232|O3|Outcome|Placebo + NicoDerm CQ (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222640|NCT01480232|O2|Outcome|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222641|NCT01480232|O1|Outcome|EVP-6124 + NicoDerm CQ (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222642|NCT01480232|O4|Outcome|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222643|NCT01480232|O3|Outcome|Placebo + NicoDerm CQ (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222644|NCT01480232|O2|Outcome|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222645|NCT01480232|O1|Outcome|EVP-6124 + NicoDerm CQ (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222668|NCT01480089|O2|Outcome|Atomized Intraperitoneal Saline (AIS)|Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
222978|NCT01479543|O1|Outcome|Group A|"Volunteers are given strain CNCM I-4034.~Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days."
222646|NCT01480232|O4|Outcome|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222647|NCT01480232|O3|Outcome|Placebo + NicoDerm CQ (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222648|NCT01480232|O2|Outcome|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222649|NCT01480232|O1|Outcome|EVP-6124 + NicoDerm CQ (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222650|NCT01480232|E4|Reported Event|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222651|NCT01480232|E3|Reported Event|Placebo + NicoDerm (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222652|NCT01480232|E2|Reported Event|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222653|NCT01480232|E1|Reported Event|EVP-6124 + NicoDerm (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
222654|NCT01480219|B3|Baseline|Total|Total of all reporting groups
222655|NCT01480219|B2|Baseline|Voriconazole|Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
222656|NCT01480219|B1|Baseline|No Voriconazole|Participants not having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
222657|NCT01480219|P2|Participant Flow|Voriconazole|Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
222658|NCT01480219|P1|Participant Flow|No Voriconazole|Participants not having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
222659|NCT01480219|O2|Outcome|Voriconazole|Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
222660|NCT01480219|O1|Outcome|No Voriconazole|Participants not having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
222661|NCT01480219|E2|Reported Event|Voriconazole|Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
222662|NCT01480219|E1|Reported Event|No Voriconazole|Participants not having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
222663|NCT01480089|B3|Baseline|Total|Total of all reporting groups
222664|NCT01480089|B2|Baseline|Atomized Intraperitoneal Saline (AIS)|Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
222665|NCT01480089|B1|Baseline|Intraperitoneal Ropivacaine(AIR)|Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
222666|NCT01480089|P2|Participant Flow|Intraperitoneal Ropivacaine(AIR)|Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
225441|NCT01472939|O1|Outcome|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
222669|NCT01480089|O1|Outcome|Intraperitoneal Ropivacaine(AIR)|Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
222670|NCT01480089|O2|Outcome|Atomized Intraperitoneal Saline (AIS)|Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
222671|NCT01480089|O1|Outcome|Intraperitoneal Ropivacaine(AIR)|Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
222672|NCT01480089|E2|Reported Event|Atomized Intraperitoneal Saline (AIS)|Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
222673|NCT01480089|E1|Reported Event|Intraperitoneal Ropivacaine(AIR)|Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
222674|NCT01480076|B3|Baseline|Total|Total of all reporting groups
222675|NCT01480076|B2|Baseline|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Treatment non-responders continued without treatment by completing quality of life questionnaires.
222676|NCT01480076|B1|Baseline|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. If deemed a treatment responder, the participant continued 10 mg fampridine twice daily for 44 weeks.
222677|NCT01480076|P1|Participant Flow|Fampridine|All participants took 10 mg fampridine twice daily for the first 4 weeks. If deemed a treatment responder, the participant continued 10 mg fampridine twice daily for 44 weeks. Treatment non-responders continued without treatment by completing quality of life questionnaires.
222678|NCT01480076|O3|Outcome|All Participants|All participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222679|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222680|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222681|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222682|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222683|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222684|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222685|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222686|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222687|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222688|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222689|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222690|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222691|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222692|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222693|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222694|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222695|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222822|NCT01479764|B1|Baseline|Sugammadex|Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
222696|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222697|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222698|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222699|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222700|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222701|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222702|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222703|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222704|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222705|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222706|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222707|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222708|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222709|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222710|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222711|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222712|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222713|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222714|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222715|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222716|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222717|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222718|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222719|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222720|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222721|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
225442|NCT01472939|O4|Outcome|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
222722|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222723|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222724|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222725|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222726|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222727|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222728|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222729|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222730|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222731|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222732|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222733|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222734|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222735|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222736|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222737|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222738|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222739|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222740|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222741|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222742|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222743|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222744|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222745|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222746|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222773|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222747|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222748|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222749|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222750|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222751|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222752|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222753|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222754|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222755|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222756|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222757|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222758|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222759|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222760|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222761|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222762|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222763|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222764|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222765|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222766|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222767|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222768|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
222769|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222770|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222771|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222772|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222774|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222775|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222776|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222777|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222778|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222779|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222780|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222781|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222782|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222783|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222784|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222785|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222786|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222787|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222788|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222789|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222790|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222791|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222792|NCT01480076|E3|Reported Event|All Participants|All participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222793|NCT01480076|E2|Reported Event|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
222794|NCT01480076|E1|Reported Event|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
222795|NCT01479868|B1|Baseline|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
222796|NCT01479868|P1|Participant Flow|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
222797|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
222798|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
222816|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
222817|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
222818|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
222819|NCT01479777|E1|Reported Event|FES Stepping|FES Stepping, twice a week, for 8 weeks.
222799|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
222800|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
222801|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
222802|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
222803|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
222804|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
222805|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
222806|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
222807|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
222808|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
222809|NCT01479868|E1|Reported Event|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
222810|NCT01479777|B1|Baseline|FES Stepping|FES Stepping, twice a week, for 8 weeks.
222811|NCT01479777|P1|Participant Flow|FES Stepping|For the next 8 weeks, we will ask you to come to the ICSCI twice (2) time per week during which you will perform FES Stepping.
222812|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
222813|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
222814|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
222815|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
222823|NCT01479764|P2|Participant Flow|Neostigmine/Glycopyrrolate|Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
222824|NCT01479764|P1|Participant Flow|Sugammadex|Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
222825|NCT01479764|O2|Outcome|Neostigmine/Glycopyrrolate|Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
222826|NCT01479764|O1|Outcome|Sugammadex|Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
222827|NCT01479764|O2|Outcome|Neostigmine/Glycopyrrolate|Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
222828|NCT01479764|O1|Outcome|Sugammadex|Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
222829|NCT01479764|E2|Reported Event|Neostigmine/Glycopyrrolate|Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
222830|NCT01479764|E1|Reported Event|Sugammadex|Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
222831|NCT01479725|B3|Baseline|Total|Total of all reporting groups
222832|NCT01479725|B2|Baseline|Non-Ulcerative IC|"HBOT for non-ulcerative IC~HBOT: HBOT"
222833|NCT01479725|B1|Baseline|Ulcerative IC|"HBOT for ulcerative IC~HBOT: HBOT"
222834|NCT01479725|P2|Participant Flow|Non-Ulcerative IC|"HBOT for non-ulcerative IC~HBOT: HBOT"
222835|NCT01479725|P1|Participant Flow|Ulcerative IC|"HBOT for ulcerative IC~HBOT: HBOT"
222836|NCT01479725|O2|Outcome|Non-Ulcerative IC|"HBOT for non-ulcerative IC~HBOT: HBOT"
222837|NCT01479725|O1|Outcome|Ulcerative IC|"HBOT for ulcerative IC~HBOT: HBOT"
222838|NCT01479725|E2|Reported Event|Non-Ulcerative IC|"HBOT for non-ulcerative IC~HBOT: HBOT"
222839|NCT01479725|E1|Reported Event|Ulcerative IC|"HBOT for ulcerative IC~HBOT: HBOT"
222840|NCT01479621|B7|Baseline|Total|Total of all reporting groups
222841|NCT01479621|B6|Baseline|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222842|NCT01479621|B5|Baseline|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
222843|NCT01479621|B4|Baseline|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222844|NCT01479621|B3|Baseline|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222845|NCT01479621|B2|Baseline|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222846|NCT01479621|B1|Baseline|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222847|NCT01479621|P7|Participant Flow|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222848|NCT01479621|P6|Participant Flow|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
222849|NCT01479621|P5|Participant Flow|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222850|NCT01479621|P4|Participant Flow|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222975|NCT01479543|O4|Outcome|Group D|"Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.~Probiotics CNCM I-4035 and CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
222851|NCT01479621|P3|Participant Flow|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222852|NCT01479621|P2|Participant Flow|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222853|NCT01479621|P1|Participant Flow|Placebo MDPI (Run-In)|Upon enrollment, participants used current asthma medications and 1 inhalation of placebo multidose dry powder inhaler (MDPI), single-blind, twice daily for 14-day (±2 days).
222854|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222855|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
222856|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222857|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222858|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222859|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222860|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222861|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
222862|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222863|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222864|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222865|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222866|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222976|NCT01479543|O3|Outcome|Group C|"Volunteers are given Probiotic CNCM I-4036.~Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
222867|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
222868|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222869|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222870|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222871|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222872|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222873|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
222874|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222875|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222876|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222877|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222878|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222879|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
222880|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222881|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222882|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
225443|NCT01472939|O3|Outcome|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
222883|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222884|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222885|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
222886|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222887|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222888|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222889|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222890|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222891|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
222892|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222893|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222894|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222895|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222896|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222897|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
222898|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
246950|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
222899|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222900|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222901|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222902|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222903|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
222904|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222905|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222906|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222907|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222908|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222909|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
222910|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222911|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222912|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222913|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222914|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222915|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
222916|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222917|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222918|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222919|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222920|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222921|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
222922|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222923|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222924|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222925|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222926|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222927|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
222928|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222929|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222930|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
225444|NCT01472939|O2|Outcome|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
222931|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
222932|NCT01479621|E6|Reported Event|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
222933|NCT01479621|E5|Reported Event|Fp MDPI 50 mcg|Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
222934|NCT01479621|E4|Reported Event|Fp MDPI 25 mcg|Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
222935|NCT01479621|E3|Reported Event|Fp MDPI 12.5 mcg|Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
222936|NCT01479621|E2|Reported Event|Fp MDPI 100 mcg|Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
222937|NCT01479621|E1|Reported Event|Flovent Diskus 100mcg|Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
222938|NCT01479595|B3|Baseline|Total|Total of all reporting groups
222939|NCT01479595|B2|Baseline|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
222940|NCT01479595|B1|Baseline|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
222941|NCT01479595|P2|Participant Flow|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
222942|NCT01479595|P1|Participant Flow|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
222943|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
222944|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
222945|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
222946|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
222947|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
222948|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
222949|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
222950|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
222951|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
222952|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
222953|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
222954|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
222955|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
222956|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
222957|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
222958|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
222959|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
222960|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
222961|NCT01479595|E2|Reported Event|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
222962|NCT01479595|E1|Reported Event|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
222963|NCT01479543|B6|Baseline|Total|Total of all reporting groups
222964|NCT01479543|B5|Baseline|Group E|"Volunteers receive a placebo.~Placebo capsule: Placebo capsule for 28 days."
222965|NCT01479543|B4|Baseline|Group D|"Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.~Probiotics CNCM I-4035 and CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
222966|NCT01479543|B3|Baseline|Group C|"Volunteers are given Probiotic CNCM I-4036.~Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
222967|NCT01479543|B2|Baseline|Group B|"Volunteers receive Probiotic CNCM I-4035.~Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days."
222968|NCT01479543|B1|Baseline|Group A|"Volunteers are given strain CNCM I-4034.~Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days."
222969|NCT01479543|P5|Participant Flow|Group E|"Volunteers receive a placebo.~Placebo capsule: Placebo capsule for 28 days."
222970|NCT01479543|P4|Participant Flow|Group D|"Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.~Probiotics CNCM I-4035 and CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
222971|NCT01479543|P3|Participant Flow|Group C|"Volunteers are given Probiotic CNCM I-4036.~Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
222972|NCT01479543|P2|Participant Flow|Group B|"Volunteers receive Probiotic CNCM I-4035.~Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days."
222973|NCT01479543|P1|Participant Flow|Group A|"Volunteers are given strain CNCM I-4034.~Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days."
222974|NCT01479543|O5|Outcome|Group E|"Volunteers receive a placebo.~Placebo capsule: Placebo capsule for 28 days."
225445|NCT01472939|O1|Outcome|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
222979|NCT01479543|E5|Reported Event|Group E|"Volunteers receive a placebo.~Placebo capsule: Placebo capsule for 28 days."
222980|NCT01479543|E4|Reported Event|Group D|"Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.~Probiotics CNCM I-4035 and CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
222981|NCT01479543|E3|Reported Event|Group C|"Volunteers are given Probiotic CNCM I-4036.~Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
222982|NCT01479543|E2|Reported Event|Group B|"Volunteers receive Probiotic CNCM I-4035.~Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days."
222983|NCT01479543|E1|Reported Event|Group A|"Volunteers are given strain CNCM I-4034.~Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days."
222984|NCT01479530|B3|Baseline|Total|Total of all reporting groups
222985|NCT01479530|B2|Baseline|Azilect®|1 mg daily; tablet; orally; 16 weeks
222986|NCT01479530|B1|Baseline|Placebo|Once daily; tablet; orally; 16 weeks
222987|NCT01479530|P2|Participant Flow|Azilect®|1 mg daily; tablet; orally; 16 weeks
222988|NCT01479530|P1|Participant Flow|Placebo|Once daily; tablet; orally; 16 weeks
222989|NCT01479530|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 16 weeks
222990|NCT01479530|O1|Outcome|Placebo|Once daily; tablet; orally; 16 weeks
222991|NCT01479530|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 16 weeks
222992|NCT01479530|O1|Outcome|Placebo|Once daily; tablet; orally; 16 weeks
222993|NCT01479530|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 16 weeks
222994|NCT01479530|O1|Outcome|Placebo|Once daily; tablet; orally; 16 weeks
222995|NCT01479530|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 16 weeks
222996|NCT01479530|O1|Outcome|Placebo|Once daily; tablet; orally; 16 weeks
222997|NCT01479530|E2|Reported Event|Azilect®|1 mg daily; tablet; orally; 16 weeks
222998|NCT01479530|E1|Reported Event|Placebo|Once daily; tablet; orally; 16 weeks
222999|NCT01479517|B4|Baseline|Total|Total of all reporting groups
223000|NCT01479517|B3|Baseline|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline~Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
223001|NCT01479517|B2|Baseline|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
223002|NCT01479517|B1|Baseline|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
223003|NCT01479517|P3|Participant Flow|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline~Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
223004|NCT01479517|P2|Participant Flow|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
223005|NCT01479517|P1|Participant Flow|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
223006|NCT01479517|O3|Outcome|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline~Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
223007|NCT01479517|O2|Outcome|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
223008|NCT01479517|O1|Outcome|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
223009|NCT01479517|O3|Outcome|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline~Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
223010|NCT01479517|O2|Outcome|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
223011|NCT01479517|O1|Outcome|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
223012|NCT01479517|O3|Outcome|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline~Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
223013|NCT01479517|O2|Outcome|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
223014|NCT01479517|O1|Outcome|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
223015|NCT01479517|O3|Outcome|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline~Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
223016|NCT01479517|O2|Outcome|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
223017|NCT01479517|O1|Outcome|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
223018|NCT01479517|E3|Reported Event|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline~Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
223019|NCT01479517|E2|Reported Event|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
223020|NCT01479517|E1|Reported Event|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
223021|NCT01479374|B4|Baseline|Total|Total of all reporting groups
223022|NCT01479374|B3|Baseline|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
223023|NCT01479374|B2|Baseline|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
223024|NCT01479374|B1|Baseline|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
223025|NCT01479374|P3|Participant Flow|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
223026|NCT01479374|P2|Participant Flow|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
223027|NCT01479374|P1|Participant Flow|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
223028|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
223029|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
223030|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
223031|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
223032|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
223033|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
223034|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
223035|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
223036|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
223037|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
223038|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
223039|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
223040|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
223041|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
223042|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
223043|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
223044|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
223045|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
223046|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
223047|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
223048|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
223049|NCT01479374|E3|Reported Event|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
223050|NCT01479374|E2|Reported Event|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
223051|NCT01479374|E1|Reported Event|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
223052|NCT01479127|B1|Baseline|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by a naso-jejunum (NJ) tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
223053|NCT01479127|P1|Participant Flow|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-Parkinson's disease (PD) medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel [LCIG]), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by a naso-jejunum (NJ) tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
223054|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
223055|NCT01479127|O2|Outcome|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms."
223056|NCT01479127|O1|Outcome|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
223057|NCT01479127|O2|Outcome|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms."
223058|NCT01479127|O1|Outcome|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
223087|NCT01479010|P1|Participant Flow|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
246951|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
223059|NCT01479127|O2|Outcome|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms."
223060|NCT01479127|O1|Outcome|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
223061|NCT01479127|O2|Outcome|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms."
223062|NCT01479127|O1|Outcome|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
223063|NCT01479127|O2|Outcome|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms."
223064|NCT01479127|O1|Outcome|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
223065|NCT01479127|O2|Outcome|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
223066|NCT01479127|O1|Outcome|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
223067|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
223068|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
223069|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
223070|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
223071|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
223072|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
223085|NCT01479127|E1|Reported Event|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
223086|NCT01479010|B1|Baseline|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
246952|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
223073|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
223074|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
223075|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
223076|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
223077|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
223078|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
223079|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
223080|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
223081|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
223082|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
223083|NCT01479127|O1|Outcome|Oral Levodopa/Carbidopa Tablet|During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)
223084|NCT01479127|E2|Reported Event|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
223088|NCT01479010|O1|Outcome|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
223089|NCT01479010|O1|Outcome|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
223090|NCT01479010|O1|Outcome|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
223091|NCT01479010|O1|Outcome|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
223092|NCT01479010|O1|Outcome|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
223093|NCT01479010|O1|Outcome|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
223094|NCT01479010|O1|Outcome|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
223095|NCT01479010|O1|Outcome|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
223096|NCT01479010|E1|Reported Event|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
223097|NCT01478971|B1|Baseline|Peginesatide Injection|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
223098|NCT01478971|P1|Participant Flow|Peginesatide Injection|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
223099|NCT01478971|O2|Outcome|Peginesatide Treatment Period|In the second six months of the study participants transitioned to peginesatide injection (the Peginesatide Treatment Period [PTP]).
223100|NCT01478971|O1|Outcome|Epoetin Standard of Care|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]).
223101|NCT01478971|O2|Outcome|Peginesatide Treatment Period|In the second six months of the study participants transitioned to peginesatide injection (the Peginesatide Treatment Period [PTP]).
223102|NCT01478971|O1|Outcome|Epoetin Standard of Care|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]).
223103|NCT01478971|O2|Outcome|Peginesatide Treatment Period|In the second six months of the study participants transitioned to peginesatide injection (the Peginesatide Treatment Period [PTP]).
223104|NCT01478971|O1|Outcome|Epoetin Standard of Care|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]).
223105|NCT01478971|O1|Outcome|Peginesatide Injection|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
223106|NCT01478971|O1|Outcome|Peginesatide Injection|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
223107|NCT01478971|O1|Outcome|Peginesatide Injection|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
223108|NCT01478971|E3|Reported Event|Peginesatide Treatment Period|In the second six months of the study participants transitioned to once monthly peginesatide injection (the Peginesatide Treatment Period [PTP]).
223109|NCT01478971|E2|Reported Event|ESA Free Week|A one-week erythropoiesis-stimulating agent (ESA)-free period following 6 months of standard of care.
223110|NCT01478971|E1|Reported Event|Epoetin Standard of Care|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]).
223111|NCT01478958|B4|Baseline|Total|Total of all reporting groups
223112|NCT01478958|B3|Baseline|High n-6 Polyunsaturated Fat Diet|n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period
223113|NCT01478958|B2|Baseline|High Monounsaturated Fat Diet|MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period
223114|NCT01478958|B1|Baseline|High Saturated Fat Diet|SFA diet: Volunteers followed a high saturated fat diet for a 4-month period
223115|NCT01478958|P3|Participant Flow|High n-6 Polyunsaturated Fat Diet|n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period
223116|NCT01478958|P2|Participant Flow|High Monounsaturated Fat Diet|MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period
223117|NCT01478958|P1|Participant Flow|High Saturated Fat Diet|SFA diet: Volunteers followed a high saturated fat diet for a 4-month period
223118|NCT01478958|O3|Outcome|High n-6 Polyunsaturated Fat Diet|n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period
223119|NCT01478958|O2|Outcome|High Monounsaturated Fat Diet|MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period
223120|NCT01478958|O1|Outcome|High Saturated Fat Diet|SFA diet: Volunteers followed a high saturated fat diet for a 4-month period
223121|NCT01478958|E3|Reported Event|High n-6 Polyunsaturated Fat Diet|n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period
223122|NCT01478958|E2|Reported Event|High Monounsaturated Fat Diet|MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period
223123|NCT01478958|E1|Reported Event|High Saturated Fat Diet|SFA diet: Volunteers followed a high saturated fat diet for a 4-month period
223124|NCT01478828|B1|Baseline|Lovastatin|"After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.~Lovastatin: oral qd varying dose escalations/de-escalations"
225446|NCT01472939|E4|Reported Event|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
223125|NCT01478828|P1|Participant Flow|Lovastatin|After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.
223126|NCT01478828|O1|Outcome|Lovastatin|After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.
223127|NCT01478828|O1|Outcome|Lovastatin|After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.
223128|NCT01478828|E1|Reported Event|Lovastatin|After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.
223129|NCT01478620|B1|Baseline|Canephron® N|3x 2 coated tablets/day for 7 days p.o.
223130|NCT01478620|P1|Participant Flow|Canephron® N|3x 2 coated tablets/day for 7 days p.o.
223131|NCT01478620|O1|Outcome|Canephron® N|3x 2 coated tablets/day for 7 days p.o.
223132|NCT01478620|E1|Reported Event|Canephron® N|3x 2 coated tablets/day for 7 days p.o.
223133|NCT01478594|B3|Baseline|Total|Total of all reporting groups
223134|NCT01478594|B2|Baseline|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223135|NCT01478594|B1|Baseline|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223136|NCT01478594|P2|Participant Flow|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223137|NCT01478594|P1|Participant Flow|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each 28-day cycle for 21 days followed by 7 days off treatment. Participants also received modified FOLFOX6 (mFOLFOX6) chemotherapy consisting of oxaliplatin, 85 mg/m^2, leucovorin 400 mg/m^2, and 5-fluorouracil 400 mg/m^2 bolus then 2400 mg/m^2 every 2 weeks on Days 1 and 15 of each cycle.
223138|NCT01478594|O4|Outcome|Bevacizumab: PIGF RNA ≥ Median|Participants with PIGF RNA levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223139|NCT01478594|O3|Outcome|Bevacizumab: PIGF RNA < Median|Participants with PIGF RNA levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223140|NCT01478594|O2|Outcome|Tivozanib: PIGF RNA ≥ Median|Participants with PIGF RNA levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223141|NCT01478594|O1|Outcome|Tivozanib: PIGF RNA < Median|Participants with PIGF RNA levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223142|NCT01478594|O4|Outcome|Bevacizumab: VEGF-D RNA ≥ Median|Participants with VEGF-D RNA levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223143|NCT01478594|O3|Outcome|Bevacizumab: VEGF-D RNA < Median|Participants with VEGF-D RNA levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223144|NCT01478594|O2|Outcome|Tivozanib: VEGF-D RNA ≥ Median|Participants with VEGF-D RNA levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223145|NCT01478594|O1|Outcome|Tivozanib: VEGF-D RNA < Median|Participants with VEGF-D RNA levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223146|NCT01478594|O4|Outcome|Bevacizumab: VEGF-C/VEGF-A RNA ≥ Median|Participants with VEGF-C/VEGF-A RNA ratio ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223147|NCT01478594|O3|Outcome|Bevacizumab: VEGF-C/VEGF-A RNA < Median|Participants with VEGF-C/VEGF-A RNA ratio < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223148|NCT01478594|O2|Outcome|Tivozanib: VEGF-C/VEGF-A RNA ≥ Median|Participants with VEGF-C/VEGF-A RNA ratio ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223149|NCT01478594|O1|Outcome|Tivozanib: VEGF-C/VEGF-A RNA < Median|Participants with VEGF-C/VEGF-A RNA ratio < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223150|NCT01478594|O4|Outcome|Bevacizumab: VEGF-A RNA ≥ Median|Participants with VEGF-C RNA levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223151|NCT01478594|O3|Outcome|Bevacizumab: VEGF-C RNA < Median|Participants with VEGF-C RNA levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223152|NCT01478594|O2|Outcome|Tivozanib: VEGF-C RNA ≥ Median|Participants with VEGF-C RNA levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223153|NCT01478594|O1|Outcome|Tivozanib: VEGF-C RNA < Median|Participants with VEGF-C RNA levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223154|NCT01478594|O4|Outcome|Bevacizumab: VEGF-A RNA ≥ Median|Participants with VEGF-A RNA levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223155|NCT01478594|O3|Outcome|Bevacizumab: VEGF-A RNA < Median|Participants with VEGF-A RNA levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223156|NCT01478594|O2|Outcome|Tivozanib: VEGF-A RNA ≥ Median|Participants with VEGF-A RNA levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223157|NCT01478594|O1|Outcome|Tivozanib: VEGF-A RNA < Median|Participants with VEGF-A RNA levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223158|NCT01478594|O4|Outcome|Bevacizumab: Neuropilin ≥ Median|Participants with neuropilin levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223159|NCT01478594|O3|Outcome|Bevacizumab: Neuropilin < Median|Participants with neuropilin levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and FOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223160|NCT01478594|O2|Outcome|Tivozanib: Neuropilin ≥ Median|Participants with neuropilin levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223161|NCT01478594|O1|Outcome|Tivozanib: Neuropilin < Median|Participants with neuropilin levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223162|NCT01478594|O4|Outcome|Bevacizumab: IL-8 ≥ Median|Participants with IL-8 levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223163|NCT01478594|O3|Outcome|Bevacizumab: IL-8 < Median|Participants with IL-8 levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223164|NCT01478594|O2|Outcome|Tivozanib: IL-8 ≥ Median|Participants with IL-8 levels ≥ median received 1.5 m tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223165|NCT01478594|O1|Outcome|Tivozanib: IL-8 < Median|Participants with IL-8 levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223166|NCT01478594|O4|Outcome|Bevacizumab: sVEGFR-3 ≥ Median|Participants with sVEGFR-3 levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223167|NCT01478594|O3|Outcome|Bevacizumab: sVEGFR-3 < Median|Participants with sVEGFR-3 levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223168|NCT01478594|O2|Outcome|Tivozanib: sVEGFR-3 ≥ Median|Participants with sVEGFR-3 levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223169|NCT01478594|O1|Outcome|Tivozanib: sVEGFR-3 < Median|Participants with sVEGFR-3 levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223170|NCT01478594|O4|Outcome|Bevacizumab: sVEGFR-2 ≥ Median|Participants with sVEGFR-2 levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223171|NCT01478594|O3|Outcome|Bevacizumab: sVEGFR-2 < Median|Participants with sVEGFR-2 levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223172|NCT01478594|O2|Outcome|Tivozanib: sVEGFR-2 ≥ Median|Participants with sVEGFR-2 levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223173|NCT01478594|O1|Outcome|Tivozanib: sVEGFR-2 < Median|Participants with sVEGFR-2 levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223430|NCT01477567|O2|Outcome|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223174|NCT01478594|O4|Outcome|Bevacizumab: VEGF-C/VEGF-A ≥ Median|Participants with VEGF-C/VEGF-A ratio ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223175|NCT01478594|O3|Outcome|Bevacizumab: VEGF-C/VEGF-A < Median|Participants with VEGF-C/VEGF-A ratio < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223176|NCT01478594|O2|Outcome|Tivozanib: VEGF-C/VEGF-A ≥ Median|Participants with VEGF-C/VEGF-A ratio ≥ median received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223177|NCT01478594|O1|Outcome|Tivozanib: VEGF-C/VEGF-A < Median|Participants with VEGF-C/VEGF-A ratio < median received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223178|NCT01478594|O4|Outcome|Bevacizumab: VEGF-C ≥ Median|Participants with VEGF-C levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223179|NCT01478594|O3|Outcome|Bevacizumab: VEGF-C < Median|Participants with VEGF-C levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223180|NCT01478594|O2|Outcome|Tivozanib: VEGF-C ≥ Median|Participants with VEGF-C levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223181|NCT01478594|O1|Outcome|Tivozanib: VEGF-C < Median|Participants with VEGF-C levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223182|NCT01478594|O4|Outcome|Bevacizumab: VEGF-A ≥ Median|Participants with VEGF-A levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223183|NCT01478594|O3|Outcome|Bevacizumab: VEGF-A < Median|Participants with VEGF-A levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223184|NCT01478594|O2|Outcome|Tivozanib: VEGF-A ≥ Median|Participants with VEGF-A levels ≥ median received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223185|NCT01478594|O1|Outcome|Tivozanib: VEGF-A < Median|Participants with VEGF-A levels < median received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223186|NCT01478594|O4|Outcome|Bevacizumab : LDH ≥ 1.5 ULN|Participants with LDH status ≥ 1.5 ULN received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223187|NCT01478594|O3|Outcome|Bevacizumab: LDH < 1.5 ULN|Participants with LDH status < 1.5 ULN received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223188|NCT01478594|O2|Outcome|Tivozanib: LDH ≥ 1.5 ULN|Participants with LDH status ≥ 1.5 ULN received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223189|NCT01478594|O1|Outcome|Tivozanib: LDH < 1.5 ULN|Participants with LDH status < 1.5 ULN received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223190|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223191|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223192|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223193|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223194|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223195|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223196|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223197|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223198|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223266|NCT01478087|P1|Participant Flow|IA Treatment|The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
223199|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 m tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223200|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223201|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223202|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223203|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223204|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223205|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223206|NCT01478594|E2|Reported Event|Bevacizumab + mFOLFOX6|Participants received a dose of 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223207|NCT01478594|E1|Reported Event|Tivozanib + mFOLFOX6|Participants received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6) chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
223208|NCT01478373|B1|Baseline|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
223209|NCT01478373|P1|Participant Flow|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
223210|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
223211|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
223212|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
223213|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
223214|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
223215|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
223216|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
223217|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
223218|NCT01478373|E1|Reported Event|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
223219|NCT01478360|B3|Baseline|Total|Total of all reporting groups
223220|NCT01478360|B2|Baseline|Placebo|Placebo intravenous injection
223221|NCT01478360|B1|Baseline|AIN457|AIN457 10 mg/kg
223222|NCT01478360|P2|Participant Flow|Placebo|Placebo intravenous injection
223223|NCT01478360|P1|Participant Flow|AIN457|AIN457 10 mg/kg
223224|NCT01478360|O2|Outcome|Placebo|Placebo intravenous injection
223225|NCT01478360|O1|Outcome|AIN457|AIN457 10 mg/kg
223226|NCT01478360|E2|Reported Event|Placebo|Placebo
223227|NCT01478360|E1|Reported Event|AIN457 10 mg/kg|AIN457 10 mg/kg
223228|NCT01478347|B1|Baseline|rMenB+OMV NZ|"Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of rMenB + OMV NZ vaccine, 2 months apart, in part I of the study. 18 subjects were enrolled in part I of the study.~In part II of the study, subjects were re-enrolled for optional blood draws and safety follow-up. Of the 18 subjects enrolled in part I of the study, only 12 subjects continued participation into protocol part II of the study. Only 11 subjects (one subject was withdrawn after visit 3 due to lost to follow-up) were included in the safety set and therefore contributed to the baseline characteristics data."
223267|NCT01478087|O1|Outcome|IA Treatment|The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
223431|NCT01477567|O1|Outcome|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223229|NCT01478347|P1|Participant Flow|rMenB+OMV NZ|Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of Recombinant Meningococcal B Vaccine with Outer Membrane Vesicle from the New Zealand Strain (rMenB + OMV NZ vaccine), 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up.
223230|NCT01478347|O1|Outcome|rMenB+OMV NZ|Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of rMenB + OMV NZ vaccine, 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up.
223231|NCT01478347|O1|Outcome|rMenB+OMV NZ|Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of rMenB + OMV NZ vaccine, 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up.
223232|NCT01478347|E1|Reported Event|rMenB+OMV NZ|Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of Recombinant Meningococcal B Vaccine with Outer Membrane Vesicle from the New Zealand Strain (rMenB + OMV NZ vaccine), 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up.
223233|NCT01478256|B3|Baseline|Total|Total of all reporting groups
223234|NCT01478256|B2|Baseline|Erythromycin|Topical Erythromycin ointment twice a day for treatment of acute blepharitis
223235|NCT01478256|B1|Baseline|Besifloxocin|Use of topical besifloxocin twice a day to treat acute blepharitis
223236|NCT01478256|P2|Participant Flow|Erythromycin|Topical Erythromycin ointment twice a day for treatment of acute blepharitis
223237|NCT01478256|P1|Participant Flow|Besifloxocin|Use of topical besifloxocin twice a day to treat acute blepharitis
223238|NCT01478256|O2|Outcome|Erythromycin|Topical Erythromycin ointment twice a day for treatment of acute blepharitis
223239|NCT01478256|O1|Outcome|Besifloxocin|Use of topical besifloxocin twice a day to treat acute blepharitis
223240|NCT01478256|O2|Outcome|Erythromycin|Topical Erythromycin ointment for treatment of acute blepharitis
223241|NCT01478256|O1|Outcome|Besifloxocin|Use of topical besifloxocin to treat acute blepharitis
223242|NCT01478256|E2|Reported Event|Erythromycin|Topical Erythromycin ointment for treatment of acute blepharitis
223243|NCT01478256|E1|Reported Event|Besifloxocin|Use of topical besifloxocin to treat acute blepharitis
223244|NCT01478113|B3|Baseline|Total|Total of all reporting groups
223245|NCT01478113|B2|Baseline|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.~Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
223246|NCT01478113|B1|Baseline|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.~Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
223247|NCT01478113|P2|Participant Flow|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.~Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
223248|NCT01478113|P1|Participant Flow|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.~Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
223249|NCT01478113|O2|Outcome|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.~Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
223250|NCT01478113|O1|Outcome|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.~Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
223251|NCT01478113|O2|Outcome|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.~Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
223268|NCT01478087|O1|Outcome|IA Treatment|The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
223269|NCT01478087|E1|Reported Event|IA Treatment|The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
223270|NCT01478048|B3|Baseline|Total|Total of all reporting groups
246953|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
223252|NCT01478113|O1|Outcome|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.~Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
223253|NCT01478113|O2|Outcome|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.~Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
223254|NCT01478113|O1|Outcome|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.~Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
223255|NCT01478113|O2|Outcome|WBT + Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.~Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
223256|NCT01478113|O1|Outcome|WBT + Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.~Amphetamine/dextroamphetamine: The amphetamine/dextroamphetamine will be in a pill formulation. The dosage of the amphetamine/dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
223257|NCT01478113|O2|Outcome|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.~Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
223258|NCT01478113|O1|Outcome|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.~Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
223259|NCT01478113|O2|Outcome|WBT + Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.~Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
223260|NCT01478113|O1|Outcome|WBT + Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.~Amphetamine/dextroamphetamine: The amphetamine/dextroamphetamine will be in a pill formulation. The dosage of the amphetamine/dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
223261|NCT01478113|O2|Outcome|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.~Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
223262|NCT01478113|O1|Outcome|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.~Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
223263|NCT01478113|E2|Reported Event|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.~Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
223264|NCT01478113|E1|Reported Event|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.~Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
223265|NCT01478087|B1|Baseline|IA Treatment|The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
223426|NCT01477567|O6|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223271|NCT01478048|B2|Baseline|Bortezomib + Dexamethasone|Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug. Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug
223272|NCT01478048|B1|Baseline|Elotuzumab + Bortezomib + Dexamethasone|Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug. Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation. Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation
223273|NCT01478048|P2|Participant Flow|Bortezomib + Dexamethasone|Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug. Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug
223274|NCT01478048|P1|Participant Flow|Elotuzumab + Bortezomib + Dexamethasone|Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug. Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation. Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation
223275|NCT01478048|O2|Outcome|Bortezomib + Dexamethasone|Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug. Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug
223276|NCT01478048|O1|Outcome|Elotuzumab + Bortezomib + Dexamethasone|Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug. Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation. Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation
223277|NCT01478048|O2|Outcome|Bortezomib + Dexamethasone|Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug. Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug
223278|NCT01478048|O1|Outcome|Elotuzumab + Bortezomib + Dexamethasone|Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug. Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation. Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation
223279|NCT01478048|O2|Outcome|Bortezomib + Dexamethasone|Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug. Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug
223280|NCT01478048|O1|Outcome|Elotuzumab + Bortezomib + Dexamethasone|Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug. Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation. Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation
223281|NCT01478048|O2|Outcome|Bortezomib + Dexamethasone|Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug. Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug
246954|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
223282|NCT01478048|O1|Outcome|Elotuzumab + Bortezomib + Dexamethasone|Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug. Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation. Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation
223283|NCT01478048|O2|Outcome|Bortezomib + Dexamethasone|Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug. Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug
223284|NCT01478048|O1|Outcome|Elotuzumab + Bortezomib + Dexamethasone|Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug. Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation. Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation
223285|NCT01478048|O2|Outcome|Bortezomib + Dexamethasone|Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug. Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug
223286|NCT01478048|O1|Outcome|Elotuzumab + Bortezomib + Dexamethasone|Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug. Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation. Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation
223287|NCT01478048|E2|Reported Event|Bortezomib + Dexamethasone|Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug. Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug
223288|NCT01478048|E1|Reported Event|Elotuzumab + Bortezomib + Dexamethasone|Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug. Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation. Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation
223289|NCT01478009|B3|Baseline|Total|Total of all reporting groups
223290|NCT01478009|B2|Baseline|Placebo|
223291|NCT01478009|B1|Baseline|KRG Extract|
223292|NCT01478009|P2|Participant Flow|Placebo|"Placebo(3times/day, 9capsules/day, 3g/day) for 12weeks~Placebo : Amount and calorie of placebo are same with KRG Extract."
223293|NCT01478009|P1|Participant Flow|KRG(Korean Red Ginseng) Extract|"KRG Extract(3times/day, 9capsules/day, 3g/day) for 12weeks~KRG Extract : KRG Extract was extracted at high temperatures (above 95℃)"
223294|NCT01478009|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
223295|NCT01478009|O1|Outcome|KRG Extract|Oral intake Korean red ginseng(3.0g/day) for 12weeks.
223296|NCT01478009|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
223297|NCT01478009|O1|Outcome|KRG Extract|Oral intake Korean red ginseng(3.0g/day) for 12weeks.
223298|NCT01478009|E2|Reported Event|Placebo|
223299|NCT01478009|E1|Reported Event|KRG Extract|
223300|NCT01477892|B3|Baseline|Total|Total of all reporting groups
223301|NCT01477892|B2|Baseline|Low Dose Remifentanil|"continuous infusion of remifentanil 0.1mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
223302|NCT01477892|B1|Baseline|High Dose Remifentanil|"continuous infusion of remifentanil 0.25mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
223303|NCT01477892|P2|Participant Flow|Low Dose Remifentanil|"continuous infusion of remifentanil 0.1mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
223427|NCT01477567|O5|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223304|NCT01477892|P1|Participant Flow|High Dose Remifentanil|"continuous infusion of remifentanil 0.25mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
223305|NCT01477892|O2|Outcome|Low Dose Remifentanil|"continuous infusion of remifentanil 0.1mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
223306|NCT01477892|O1|Outcome|High Dose Remifentanil|"continuous infusion of remifentanil 0.25mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
223307|NCT01477892|O2|Outcome|Low Dose Remifentanil|"continuous infusion of remifentanil 0.1mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
223308|NCT01477892|O1|Outcome|High Dose Remifentanil|"continuous infusion of remifentanil 0.25mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
223309|NCT01477892|E2|Reported Event|Low Dose Remifentanil|"continuous infusion of remifentanil 0.1mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
223310|NCT01477892|E1|Reported Event|High Dose Remifentanil|"continuous infusion of remifentanil 0.25mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
223311|NCT01477853|B4|Baseline|Total|Total of all reporting groups
223312|NCT01477853|B3|Baseline|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
223313|NCT01477853|B2|Baseline|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
223314|NCT01477853|B1|Baseline|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
223315|NCT01477853|P3|Participant Flow|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
223316|NCT01477853|P2|Participant Flow|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
223317|NCT01477853|P1|Participant Flow|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
223318|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
223319|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
223320|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
223321|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
223322|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
223323|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
223324|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
223325|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
223326|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
223327|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
248838|NCT01396005|B3|Baseline|Total|Total of all reporting groups
223328|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
223329|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
223330|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
223331|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
223332|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
223333|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
223334|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
223335|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
223336|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
223337|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
223338|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
223339|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
223340|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
223341|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
223342|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
223343|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
223344|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
223345|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
223346|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
223347|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
223348|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
223349|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
251905|NCT01385995|O1|Outcome|Therapeutic CPAP|
223350|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
223351|NCT01477853|E3|Reported Event|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
223352|NCT01477853|E2|Reported Event|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
223353|NCT01477853|E1|Reported Event|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
223354|NCT01477762|B5|Baseline|Total|Total of all reporting groups
223355|NCT01477762|B4|Baseline|PTSD Positive: Dexamethasone First, Then Placebo|"Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
223356|NCT01477762|B3|Baseline|PTSD Positive: Placebo First, Then Dexamethosone|"Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
223357|NCT01477762|B2|Baseline|PTSD Negative: Dexamethasone First, Then Placebo|"Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
223358|NCT01477762|B1|Baseline|PTSD Negative: Placebo First, Then Dexamethasone|"Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
223359|NCT01477762|P4|Participant Flow|PTSD Positive: Dexamethasone First, Then Placebo|"Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
223360|NCT01477762|P3|Participant Flow|PTSD Positive: Placebo First, Then Dexamethosone|"Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
223361|NCT01477762|P2|Participant Flow|PTSD Negative: Dexamethasone First, Then Placebo|"Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
223362|NCT01477762|P1|Participant Flow|PTSD Negative: Placebo First, Then Dexamethasone|"Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
223363|NCT01477762|O4|Outcome|PTSD Positive: Dexamethasone First, Then Placebo|"Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
223364|NCT01477762|O3|Outcome|PTSD Positive: Placebo First, Then Dexamethosone|"Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
223365|NCT01477762|O2|Outcome|PTSD Negative: Dexamethasone First, Then Placebo|"Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
223366|NCT01477762|O1|Outcome|PTSD Negative: Placebo First, Then Dexamethasone|"Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
223367|NCT01477762|O4|Outcome|PTSD Positive: Dexamethasone First, Then Placebo|"Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
223368|NCT01477762|O3|Outcome|PTSD Positive: Placebo First, Then Dexamethosone|"Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
223428|NCT01477567|O4|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223369|NCT01477762|O2|Outcome|PTSD Negative: Dexamethasone First, Then Placebo|"Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
223370|NCT01477762|O1|Outcome|PTSD Negative: Placebo First, Then Dexamethasone|"Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
223371|NCT01477762|O4|Outcome|PTSD Positive: Dexamethasone First, Then Placebo|"Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
223372|NCT01477762|O3|Outcome|PTSD Positive: Placebo First, Then Dexamethosone|"Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
223373|NCT01477762|O2|Outcome|PTSD Negative: Dexamethasone First, Then Placebo|"Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
223374|NCT01477762|O1|Outcome|PTSD Negative: Placebo First, Then Dexamethasone|"Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
223375|NCT01477762|O4|Outcome|PTSD Positive: Dexamethasone First, Then Placebo|"Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
223376|NCT01477762|O3|Outcome|PTSD Positive: Placebo First, Then Dexamethosone|"Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
223377|NCT01477762|O2|Outcome|PTSD Negative: Dexamethasone First, Then Placebo|"Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
223378|NCT01477762|O1|Outcome|PTSD Negative: Placebo First, Then Dexamethasone|"Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
223379|NCT01477762|E4|Reported Event|PTSD Positive: Dexamethasone First, Then Placebo|"Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
223380|NCT01477762|E3|Reported Event|PTSD Positive: Placebo First, Then Dexamethosone|"Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
223381|NCT01477762|E2|Reported Event|PTSD Negative: Dexamethasone First, Then Placebo|"Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
223382|NCT01477762|E1|Reported Event|PTSD Negative: Placebo First, Then Dexamethasone|"Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
223383|NCT01477749|B1|Baseline|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.~sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
223384|NCT01477749|P1|Participant Flow|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.~sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
223385|NCT01477749|O1|Outcome|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.~sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
223429|NCT01477567|O3|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223386|NCT01477749|O1|Outcome|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.~sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
223387|NCT01477749|O1|Outcome|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.~sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
223388|NCT01477749|O1|Outcome|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.~sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
223389|NCT01477749|E1|Reported Event|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.~sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
223390|NCT01477710|B1|Baseline|All Participants|Each clinician will connect a SAVe ventilator to a face mask and hold the mask in place on the mannequin with two hands while maintaining the airway on the correct position for 10 minutes. Then, each will attach the face mask to the mannequin using the mask and mask strap included in the ventilator kit for 10 minutes. Finally, each will blindly insert a supralaryngeal airway (the King lT) and connect the SAVe ventilator to the connector and provide ventilation for 10 minutes.
223391|NCT01477710|P1|Participant Flow|All Participants|Each participant will perform 3 tasks -- in the same order. First, the clinician will connect a SAVe ventilator to a face mask and hold the mask in place on the mannequin with two hands while maintaining the airway on the correct position for 10 minutes. Next, the clinician will attach the face mask to the mannequin using the mask and mask strap included in the ventilator kit for 10 minutes. Finally, the clinician will blindly insert a supralaryngeal airway (the King lT) and connect the SAVe ventilator to the connector and provide ventilation for 10 minutes.
223392|NCT01477710|O3|Outcome|Airway|Using a supraglottic airway
223393|NCT01477710|O2|Outcome|Strap Mask|Mask is strapped to model using a securing device
223394|NCT01477710|O1|Outcome|Hold Mask|Mask is held in place by caregiver.
223395|NCT01477710|E3|Reported Event|Airway|
223396|NCT01477710|E2|Reported Event|Strap Mask|
223397|NCT01477710|E1|Reported Event|Hold Mask|
223398|NCT01477567|B8|Baseline|Total|Total of all reporting groups
223399|NCT01477567|B7|Baseline|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
223400|NCT01477567|B6|Baseline|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223401|NCT01477567|B5|Baseline|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223402|NCT01477567|B4|Baseline|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223403|NCT01477567|B3|Baseline|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223404|NCT01477567|B2|Baseline|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223405|NCT01477567|B1|Baseline|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223406|NCT01477567|P7|Participant Flow|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
223407|NCT01477567|P6|Participant Flow|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223408|NCT01477567|P5|Participant Flow|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223409|NCT01477567|P4|Participant Flow|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223410|NCT01477567|P3|Participant Flow|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223411|NCT01477567|P2|Participant Flow|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223412|NCT01477567|P1|Participant Flow|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223413|NCT01477567|O7|Outcome|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
223414|NCT01477567|O6|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223415|NCT01477567|O5|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223416|NCT01477567|O4|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223417|NCT01477567|O3|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223418|NCT01477567|O2|Outcome|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223419|NCT01477567|O1|Outcome|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223420|NCT01477567|O5|Outcome|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
223421|NCT01477567|O4|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223422|NCT01477567|O3|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223423|NCT01477567|O2|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223424|NCT01477567|O1|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223425|NCT01477567|O7|Outcome|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
223433|NCT01477567|O6|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223434|NCT01477567|O5|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223435|NCT01477567|O4|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223436|NCT01477567|O3|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223437|NCT01477567|O2|Outcome|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223438|NCT01477567|O1|Outcome|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223439|NCT01477567|O6|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223440|NCT01477567|O5|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223441|NCT01477567|O4|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223442|NCT01477567|O3|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223443|NCT01477567|O2|Outcome|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223444|NCT01477567|O1|Outcome|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223445|NCT01477567|O6|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223446|NCT01477567|O5|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223447|NCT01477567|O4|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223448|NCT01477567|O3|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223449|NCT01477567|O2|Outcome|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223450|NCT01477567|O1|Outcome|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223451|NCT01477567|O7|Outcome|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
223452|NCT01477567|O6|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223453|NCT01477567|O5|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223454|NCT01477567|O4|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223455|NCT01477567|O3|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223456|NCT01477567|O2|Outcome|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223457|NCT01477567|O1|Outcome|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223458|NCT01477567|E7|Reported Event|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
223459|NCT01477567|E6|Reported Event|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223460|NCT01477567|E5|Reported Event|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223461|NCT01477567|E4|Reported Event|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223462|NCT01477567|E3|Reported Event|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223463|NCT01477567|E2|Reported Event|1 mg LY3009385|LY3009385: 1 milligram (mg), subcutaneous (SC) injection, single dose on Day 1
223464|NCT01477567|E1|Reported Event|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
223465|NCT01477463|B3|Baseline|Total|Total of all reporting groups
223466|NCT01477463|B2|Baseline|Arm B: Placebo|Placebo - subjects may cross over to vitamin D treatment after placebo treatment is complete
223467|NCT01477463|B1|Baseline|Arm A: Vitamin D|"4,000 IU oral vitamin D3~Vitamin D3: 4,000 IU oral vitamin D3"
223468|NCT01477463|P2|Participant Flow|Arm B: Placebo|Placebo - patients may cross over to vitamin D3 treatment after placebo treatment
223469|NCT01477463|P1|Participant Flow|Arm A: Vitamin D|"4,000 IU oral vitamin D3~Vitamin D3: 4,000 IU oral vitamin D3"
223470|NCT01477463|O2|Outcome|Arm B: Placebo|Placebo - inactive capsule
223471|NCT01477463|O1|Outcome|Arm A: Vitamin D|"4,000 IU oral vitamin D3~Vitamin D3: 4,000 IU oral vitamin D3"
223472|NCT01477463|O2|Outcome|Arm B: Placebo|Placebo (inactive capsule)
223473|NCT01477463|O1|Outcome|Arm A: Vitamin D|"4,000 IU oral vitamin D3~Vitamin D3: 4,000 IU oral vitamin D3"
223474|NCT01477463|O1|Outcome|All Patients Treated With Vitamin D3|"4,000 IU oral vitamin D3~Vitamin D3: 4,000 IU oral vitamin D3"
223475|NCT01477463|O1|Outcome|All Patients Treated With Vitamin D3|"4,000 IU oral vitamin D3~Vitamin D3: 4,000 IU oral vitamin D3"
223476|NCT01477463|E2|Reported Event|Arm B: Placebo|Placebo (inactive capsule)
223477|NCT01477463|E1|Reported Event|Arm A: Vitamin D|"4,000 IU oral vitamin D3~Vitamin D3: 4,000 IU oral vitamin D3"
223478|NCT01477450|B4|Baseline|Total|Total of all reporting groups
223479|NCT01477450|B3|Baseline|3 L/Min ; 48 mL|"Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
223480|NCT01477450|B2|Baseline|2 L/Min ; 32 mL|"Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
223481|NCT01477450|B1|Baseline|1 L/Min ; 16 mL|"Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
223482|NCT01477450|P3|Participant Flow|3 L/Min ; 48 mL|"Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
251906|NCT01385995|O2|Outcome|Sham CPAP|
223483|NCT01477450|P2|Participant Flow|2 L/Min ; 32 mL|"Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
223484|NCT01477450|P1|Participant Flow|1 L/Min ; 16 mL|"Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
223485|NCT01477450|O3|Outcome|3 L/Min ; 48 mL|"Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
223486|NCT01477450|O2|Outcome|2 L/Min ; 32 mL|"Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
223487|NCT01477450|O1|Outcome|1 L/Min ; 16 mL|"Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
223488|NCT01477450|E3|Reported Event|3 L/Min ; 48 mL|"Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
223489|NCT01477450|E2|Reported Event|2 L/Min ; 32 mL|"Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
223490|NCT01477450|E1|Reported Event|1 L/Min ; 16 mL|"Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
223491|NCT01477333|B1|Baseline|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
223492|NCT01477333|P1|Participant Flow|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
223493|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
223494|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
223495|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
223496|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
223497|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
223498|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
223499|NCT01477333|O4|Outcome|Class III to Class III|UT-15C SR BID
223500|NCT01477333|O3|Outcome|Class III to Class II|UT-15C SR BID
223501|NCT01477333|O2|Outcome|Class II to Class III|UT-15C SR BID
223502|NCT01477333|O1|Outcome|Class II to Class II|UT-15C SR BID
223503|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
223504|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
223505|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
223506|NCT01477333|E1|Reported Event|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
223507|NCT01477320|B3|Baseline|Total|Total of all reporting groups
223508|NCT01477320|B2|Baseline|Placebo and Tube Feed.|"Placebo and tube feed: Patients randomized to Placebo group placebo Comparator will receive tube feed plus an Placebo."
223509|NCT01477320|B1|Baseline|Pantoprazole 40mg IV Daily and Tube Feed|"Pantoprazole 40 mg IV daily and tube feed.: Patients randomized to the control group active Comparator will receive tube feed plus an Pantoprazole 40 mg IV daily."
223510|NCT01477320|P2|Participant Flow|Placebo and Tube Feed.|"Placebo and tube feed: Patients randomized to Placebo group placebo Comparator will receive tube feed plus an Placebo."
223511|NCT01477320|P1|Participant Flow|Pantoprazole 40mg IV Daily and Tube Feed|"Pantoprazole 40 mg IV daily and tube feed.: Patients randomized to the control group active Comparator will receive tube feed plus an Pantoprazole 40 mg IV daily."
223512|NCT01477320|O2|Outcome|Placebo and Tube Feed.|"Placebo and tube feed: Patients randomized to Placebo group placebo Comparator will receive tube feed plus an Placebo."
223513|NCT01477320|O1|Outcome|Pantoprazole 40mg IV Daily and Tube Feed|"Pantoprazole 40 mg IV daily and tube feed.: Patients randomized to the control group active Comparator will receive tube feed plus an Pantoprazole 40 mg IV daily."
223514|NCT01477320|O2|Outcome|Placebo and Tube Feed.|"Placebo and tube feed: Patients randomized to Placebo group placebo Comparator will receive tube feed plus an Placebo."
223515|NCT01477320|O1|Outcome|Pantoprazole 40mg IV Daily and Tube Feed|"Pantoprazole 40 mg IV daily and tube feed.: Patients randomized to the control group active Comparator will receive tube feed plus an Pantoprazole 40 mg IV daily."
223516|NCT01477320|E2|Reported Event|Placebo and Tube Feed.|"Placebo and tube feed: Patients randomized to Placebo group placebo Comparator will receive tube feed plus an Placebo."
223517|NCT01477320|E1|Reported Event|Pantoprazole 40mg IV Daily and Tube Feed|"Pantoprazole 40 mg IV daily and tube feed.: Patients randomized to the control group active Comparator will receive tube feed plus an Pantoprazole 40 mg IV daily."
223518|NCT01476748|B4|Baseline|Total|Total of all reporting groups
223519|NCT01476748|B3|Baseline|Storz Reusable Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
223520|NCT01476748|B2|Baseline|Ethicon Xcel Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
223521|NCT01476748|B1|Baseline|Covidien Veraport Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
223522|NCT01476748|P3|Participant Flow|Storz Reusable Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
223523|NCT01476748|P2|Participant Flow|Ethicon Xcel Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
223524|NCT01476748|P1|Participant Flow|Covidien Veraport Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
223525|NCT01476748|O3|Outcome|Storz Reusable Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
223526|NCT01476748|O2|Outcome|Ethicon Xcel Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
223527|NCT01476748|O1|Outcome|Covidien Versaport Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
223528|NCT01476748|O3|Outcome|Storz Reusable Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
223529|NCT01476748|O2|Outcome|Ethicon Xcel Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
223530|NCT01476748|O1|Outcome|Covidien Versaport Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
223531|NCT01476748|E3|Reported Event|Storz Reusable Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
223532|NCT01476748|E2|Reported Event|Ethicon Xcel Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
223533|NCT01476748|E1|Reported Event|Covidien Veraport Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
223534|NCT01476722|B1|Baseline|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
223535|NCT01476722|P1|Participant Flow|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
223536|NCT01476722|O1|Outcome|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
223537|NCT01476722|O1|Outcome|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
223538|NCT01476722|O1|Outcome|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
223539|NCT01476722|O1|Outcome|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
223540|NCT01476722|E1|Reported Event|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
223541|NCT01476696|B1|Baseline|Entire Study Population|"Participants enrolled in Part A, Part A and B, or only Part B of study. Part A: 0.03 up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period in Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then PD response measured 4 hours later. Based on 4-hour PD response, each participant assigned to 0.08 or 0.06 mg/kg Prasugrel once daily for remainder of first dosing period. For second 14 ± 4-day period, participants assigned to 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on steady-state PD response at end of first dosing period, so that the second dose would be unlikely to exceed 50% platelet inhibition."
223542|NCT01476696|P3|Participant Flow|Part A Then Part B: Prasugrel Single Dose Then Once-Daily Dose|"Participants who enrolled in Part A and B of study. Part A: 0.03 up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period in Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then PD response measured 4 hours later. Based on 4-hour PD response, each participant assigned to 0.08 or 0.06 mg/kg Prasugrel once daily for remainder of first dosing period. For second 14 ± 4-day period, participants assigned to 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on steady-state PD response at end of first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition."
223543|NCT01476696|P2|Participant Flow|Part B: Prasugrel Once-Daily Dose|"Participants who only enrolled in Part B of the study.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period during Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then pharmacodynamic (PD) response measured 4 hours later. Based on 4-hour PD response, each participant assigned to either 0.08 or 0.06 mg/kg Prasugrel, administered orally, once daily for the remainder of the first dosing period in Part B. For the second continuous 14 ± 4-day period, participants were administered 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on their steady-state PD response at the end of the first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition. Participants received study drug for a total of 28 ± 8 days during Part B of the study."
223544|NCT01476696|P1|Participant Flow|Part A: Prasugrel Single Dose|"Participants who only enrolled in Part A of the study.~Part A: 0.03 milligrams per kilogram (mg/kg) up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant in order to achieve desired platelet inhibition (20% to 50%). Single dose administered orally [oral-disintegrating tablet (ODT)] up to 3 times, at different mg/kg doses, with up to 18 days between doses."
223545|NCT01476696|O1|Outcome|Part B: Prasugrel Once-Daily Dose|Part B: daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period during Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then pharmacodynamic (PD) response measured 4 hours later. Based on 4-hour PD response, each participant assigned to either 0.08 or 0.06 mg/kg Prasugrel administered orally, once daily for the remainder of the first dosing period in Part B. For the second continuous 14 ± 4-day period, participants were administered 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on their steady-state PD response at the end of the first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition. Participants received study drug for a total of 28 ± 8 days during Part B of the study.
223546|NCT01476696|O4|Outcome|Part B: Prasugrel Once-Daily Dose (0.12 mg/kg)|Participants who received 0.12 mg/kg Prasugrel administered orally, ODT, once daily, anytime (first or second dosing period) during Part B of the study, for a total of up to 36 days.
223547|NCT01476696|O3|Outcome|Part B: Prasugrel Once-Daily Dose (0.08 mg/kg)|Participants who received 0.08 mg/kg Prasugrel administered orally, ODT, once daily, anytime (first or second dosing period) during Part B of the study, for a total of up to 36 days.
223548|NCT01476696|O2|Outcome|Part B: Prasugrel Once-Daily Dose (0.06 mg/kg)|Participants who received 0.06 mg/kg Prasugrel administered orally, ODT, once daily, anytime (first or second dosing period) during Part B of the study, for a total of up to 36 days.
223549|NCT01476696|O1|Outcome|Part B: Baseline|Participants in Part B of the study, prior to receiving treatment (Prasugrel once-daily doses).
223550|NCT01476696|O1|Outcome|Part A: Prasugrel Single Dose|Part A of the study: 0.03 up to 0.60 milligrams per kilogram (mg/kg) Prasugrel, each dose titrated up or down for each participant in order to achieve desired platelet inhibition (20% to 50%). Single dose administered orally [oral-disintegrating tablet (ODT)] up to 3 times, at different mg/kg doses, with up to 18 days between doses.
223551|NCT01476696|O1|Outcome|Entire Study Population|"Participants enrolled in Part A, Part A and B, or only Part B of study. Part A: 0.03 up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period in Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then PD response measured 4 hours later. Based on 4-hour PD response, each participant assigned to 0.08 or 0.06 mg/kg Prasugrel once daily for remainder of first dosing period. For second 14 ± 4-day period, participants assigned to 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on steady-state PD response at end of first dosing period, so that the second dose would be unlikely to exceed 50% platelet inhibition."
223552|NCT01476696|O1|Outcome|Entire Study Population|"Participants enrolled in Part A, Part A and B, or only Part B of study. Part A: 0.03 up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period in Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then PD response measured 4 hours later. Based on 4-hour PD response, each participant assigned to 0.08 or 0.06 mg/kg Prasugrel once daily for remainder of first dosing period. For second 14 ± 4-day period, participants assigned to 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on steady-state PD response at end of first dosing period, so that the second dose would be unlikely to exceed 50% platelet inhibition."
223553|NCT01476696|E4|Reported Event|Part A and Part B Participants: During Part B|"Events reported during Part B for those participants who enrolled in Part A and Part B of study.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period during Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then pharmacodynamic (PD) response measured 4 hours later. Based on 4-hour PD response, each participant assigned to either 0.08 or 0.06 mg/kg Prasugrel administered orally, once daily for the remainder of the first dosing period in Part B. For the second continuous 14 ± 4-day period, participants were administered 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on their steady-state PD response at the end of the first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition. Participants received study drug for a total of 28 ± 8 days during Part B of the study."
223554|NCT01476696|E3|Reported Event|Part A and Part B Participants: During Part A|"Events reported during Part A for those participants who enrolled in Part A and Part B of study.~Part A: 0.03 mg/kg up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant in order to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses."
223555|NCT01476696|E2|Reported Event|Part B: Prasugrel Once-Daily Dose|"Participants who only enrolled in Part B of the study.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period during Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then pharmacodynamic (PD) response measured 4 hours later. Based on 4-hour PD response, each participant assigned to either 0.08 or 0.06 mg/kg Prasugrel administered orally, once daily for the remainder of the first dosing period in Part B. For the second continuous 14 ± 4-day period, participants were administered 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on their steady-state PD response at the end of the first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition. Participants received study drug for a total of 28 ± 8 days during Part B of the study."
223556|NCT01476696|E1|Reported Event|Part A: Prasugrel Single Dose|"Participants who only enrolled in Part A of the study.~Part A: 0.03 milligrams per kilogram (mg/kg) up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant in order to achieve desired platelet inhibition (20% to 50%). Single dose administered orally [oral-disintegrating tablet (ODT)] up to 3 times, at different mg/kg doses, with up to 18 days between doses."
223557|NCT01476475|B3|Baseline|Total|Total of all reporting groups
223558|NCT01476475|B2|Baseline|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223559|NCT01476475|B1|Baseline|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223560|NCT01476475|P2|Participant Flow|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223561|NCT01476475|P1|Participant Flow|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously once daily (QD) for 24 weeks. Dose individually adjusted.
223562|NCT01476475|O2|Outcome|Insulin Glargine (Lantus® SoloSTAR®)|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223563|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223564|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223565|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223566|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223567|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223568|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223569|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223570|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223571|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223572|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223573|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223574|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223575|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223576|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223577|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223578|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223579|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223580|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223581|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223582|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223583|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223584|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223585|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223586|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223587|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223588|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223589|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
223590|NCT01476475|E2|Reported Event|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted (median exposure: 169 days).
223591|NCT01476475|E1|Reported Event|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted (median exposure: 169 days).
223592|NCT01476345|B1|Baseline|All Participants|A single 0.5 units/kilogram (U/kg) dose of LY2963016 or a single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
223593|NCT01476345|P2|Participant Flow|Lantus/LY/Lantus/LY|"Sequence 2: A single 0.5 U/kg dose of Lantus administered subcutaneously during Periods 1 and 3.~A single 0.5 U/kg dose of LY2963016 administered subcutaneously during Periods 2 and 4.~Minimum washout interval of 7 days between each period."
223594|NCT01476345|P1|Participant Flow|LY/Lantus/LY/Lantus|"Sequence 1: A single 0.5 units/kilogram (U/kg) dose of LY2963016 (LY) administered subcutaneously during Periods 1 and 3.~A single 0.5 U/kg dose of Lantus administered subcutaneously during Periods 2 and 4.~Minimum washout interval of 7 days between each period."
223595|NCT01476345|O2|Outcome|Lantus|A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
223596|NCT01476345|O1|Outcome|LY2963016|A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
223597|NCT01476345|O2|Outcome|Lantus|A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
223598|NCT01476345|O1|Outcome|LY2963016|A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
223599|NCT01476345|O2|Outcome|Lantus|A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
223600|NCT01476345|O1|Outcome|LY2963016|A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
223601|NCT01476345|O2|Outcome|Lantus|A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
223602|NCT01476345|O1|Outcome|LY2963016|A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
223603|NCT01476345|E2|Reported Event|Lantus|A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
223604|NCT01476345|E1|Reported Event|LY2963016|A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
223605|NCT01476202|B4|Baseline|Total|Total of all reporting groups
223606|NCT01476202|B3|Baseline|Nicotine Gum 2 mg|Participants self administered a single dose of 2 mg nicotine lozenge.
223607|NCT01476202|B2|Baseline|Nicotine Lozenge 2 mg|Participants self administered a single dose of 2 mg nicotine lozenge.
223608|NCT01476202|B1|Baseline|Nicotine Mouth Strip 2.5 mg|Participants self administered a single dose of 2.5 mg nicotine mouth strip.
223609|NCT01476202|P3|Participant Flow|Nicotine Gum 2 mg|Participants self administered a single dose of 2 mg nicotine gum.
223610|NCT01476202|P2|Participant Flow|Nicotine Lozenge 2 mg|Participants self administered a single dose of 2 mg nicotine lozenge.
223611|NCT01476202|P1|Participant Flow|Nicotine Mouth Strip 2.5 Milligram (mg)|Participants self administered a single dose of 2.5 mg nicotine mouth strip.
223612|NCT01476202|O3|Outcome|Nicotine Gum 2 mg|Participants self administered single dose of 2 mg nicotine gum.
223613|NCT01476202|O2|Outcome|Nicotine Lozenge 2 mg|Participants self administered single dose of 2 mg nicotine lozenge.
223614|NCT01476202|O1|Outcome|Nicotine Mouth Strip 2.5 Milligram (mg)|Participants self administered single dose of 2.5 mg nicotine mouth strip.
223615|NCT01476202|O3|Outcome|Nicotine Gum 2 mg|Participants self administered a single dose of 2 mg nicotine gum.
223616|NCT01476202|O2|Outcome|Nicotine Lozenge 2 mg|Participants self administered a single dose of 2 mg nicotine lozenge.
223617|NCT01476202|O1|Outcome|Nicotine Mouth Strip 2.5 mg|Participants self administered a single dose of 2.5 mg nicotine mouth strip.
223618|NCT01476202|E3|Reported Event|Nicotine Gum 2 mg|Participants self administered single dose of 2 mg nicotine gum.
223619|NCT01476202|E2|Reported Event|Nicotine Lozenge 2 mg|Participants self administered single dose of 2 mg nicotine lozenge.
223620|NCT01476202|E1|Reported Event|Nicotine Mouth Strip 2.5 mg|Participants self administered single dose of 2.5 mg nicotine mouth strip.
223621|NCT01475955|B6|Baseline|Total|Total of all reporting groups
223622|NCT01475955|B5|Baseline|Vehicle (VEH) + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visit 1 and Visit 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223623|NCT01475955|B4|Baseline|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
223624|NCT01475955|B3|Baseline|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
223625|NCT01475955|B2|Baseline|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
223626|NCT01475955|B1|Baseline|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
223627|NCT01475955|P5|Participant Flow|Vehicle + BLUE Light Treatment|"Vehicle (VEH) group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle (VEH) Photodynamic Therapy (PDT) : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223628|NCT01475955|P4|Participant Flow|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223629|NCT01475955|P3|Participant Flow|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223630|NCT01475955|P2|Participant Flow|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223631|NCT01475955|P1|Participant Flow|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5
223632|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223633|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223634|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223635|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223636|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223637|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223638|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223639|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223640|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223641|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223642|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223643|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223644|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223645|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223646|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223647|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223648|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223649|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223650|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223651|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223652|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223653|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223654|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223655|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223656|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223657|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223658|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223659|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223660|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223661|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223662|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223663|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
251907|NCT01385995|O1|Outcome|Therapeutic CPAP|
223664|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223665|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223666|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223667|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223668|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223669|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223670|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223671|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223672|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223673|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223674|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223675|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223676|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223677|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223678|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223679|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223680|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223681|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223682|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223683|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223684|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223685|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223686|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223687|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223688|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
251908|NCT01385995|O2|Outcome|Sham CPAP|
223689|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223690|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223691|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223692|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223693|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223694|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223695|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223696|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223697|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223698|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223699|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223700|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223701|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223702|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223703|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223704|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223705|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223706|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223707|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223708|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223709|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223710|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223711|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223712|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223713|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
251909|NCT01385995|O1|Outcome|Therapeutic CPAP|
223714|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223715|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223716|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223717|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223718|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223719|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223720|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223721|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223722|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223723|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223724|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223725|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223726|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223727|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223728|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223729|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223730|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223731|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223732|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223733|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223734|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223735|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223736|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223737|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223738|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
252118|NCT01385189|O1|Outcome|10 μg Na-GST-1/Alhydrogel|
223739|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223740|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223741|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223742|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223743|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223744|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223745|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223746|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223747|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223748|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223749|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223750|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223751|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223752|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223753|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223754|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223755|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223756|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223757|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223758|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223759|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223760|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223761|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223762|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223763|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
256970|NCT01369745|E3|Reported Event|Prednisone|Prednisone 5 mg once daily
223764|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223765|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223766|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223767|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223768|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223769|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223770|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223771|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223772|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223773|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223774|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223775|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223776|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223777|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223778|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223779|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223780|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223781|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223782|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223783|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223784|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223785|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223786|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223787|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223788|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
261103|NCT01357239|O2|Outcome|Placebo|2 capsules of placebo per intake
223789|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223790|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223791|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223792|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223793|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223794|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223795|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223796|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223797|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223798|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223799|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
223800|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223801|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223802|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223803|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223804|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223805|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment at Visit 1 and Vi|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223806|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223807|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223808|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223809|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223810|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223811|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223812|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223813|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223814|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223815|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223816|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223817|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223818|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223819|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223820|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223821|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223822|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223823|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223824|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223825|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223826|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223827|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223828|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223829|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223830|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223831|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223832|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223833|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223834|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223835|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
223836|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223837|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223838|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
261418|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
223839|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223840|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223841|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223842|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223843|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223844|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223845|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223846|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223847|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223848|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223849|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223850|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223851|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223852|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223853|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223854|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223855|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223856|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223857|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223858|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223859|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223860|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223861|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223862|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223863|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
224297|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
223864|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223865|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223866|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223867|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223868|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223869|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223870|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223871|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223872|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223873|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223874|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223875|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223876|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223877|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223878|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223879|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223880|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223881|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223882|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223883|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223884|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223885|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223886|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223887|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223888|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
224298|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
223889|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223890|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223891|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223892|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223893|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223894|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223895|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223896|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223897|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223898|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223899|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223900|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223901|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223902|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223903|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223904|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223905|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223906|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223907|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223908|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223909|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223910|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223911|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223912|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223913|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
224299|NCT01475175|E1|Reported Event|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
223914|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223915|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223916|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223917|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223918|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223919|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223920|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223921|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223922|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Vist 1 and Visit 5 . Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223923|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223924|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223925|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223926|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223927|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Vist 1 and Visit 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223928|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223929|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223930|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation prior to BLUE light treatment at Vist 1 and Visit 5
223931|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223932|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment, at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223933|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223934|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223935|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
223936|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
223937|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223938|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
224300|NCT01475097|B3|Baseline|Total|Total of all reporting groups
223939|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223940|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223941|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223942|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223943|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223944|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223945|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223946|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223947|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223948|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223949|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223950|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223951|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223952|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group were randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223953|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223954|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223955|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223956|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223957|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223958|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223959|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223960|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223961|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223962|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. . Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223963|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
224301|NCT01475097|B2|Baseline|Iopamidol 370mgI/mL|Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
223964|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223965|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223966|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223967|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223968|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223969|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223970|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation,prior to BLUE light treatment at Visits 1 and 5.
223971|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223972|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223973|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223974|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223975|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223976|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223977|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
223978|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223979|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223980|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223981|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
223982|NCT01475955|E5|Reported Event|Vehicle PDT|"VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group."
223983|NCT01475955|E4|Reported Event|Spot ALA 2-hour|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation
223984|NCT01475955|E3|Reported Event|Broad Area ALA 3-hour|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation
223985|NCT01475955|E2|Reported Event|Broad Area ALA 2-hour|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation
223986|NCT01475955|E1|Reported Event|Broad Area ALA 1-hour|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation
223987|NCT01475851|B3|Baseline|Total|Total of all reporting groups
223988|NCT01475851|B2|Baseline|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
223989|NCT01475851|B1|Baseline|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
223990|NCT01475851|P2|Participant Flow|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
223991|NCT01475851|P1|Participant Flow|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
223992|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
225447|NCT01472939|E3|Reported Event|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
223993|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
223994|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
223995|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
223996|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
223997|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
223998|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
223999|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
224000|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
224001|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
224002|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
224003|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
224004|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
224005|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
224006|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
224007|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
224008|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
224009|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
224010|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
224011|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
224012|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
224013|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
224014|NCT01475851|E2|Reported Event|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
224015|NCT01475851|E1|Reported Event|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
224016|NCT01475838|B3|Baseline|Total|Total of all reporting groups
224017|NCT01475838|B2|Baseline|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
224018|NCT01475838|B1|Baseline|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
224019|NCT01475838|P2|Participant Flow|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a protease inhibitor (PI) (atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)) boosted with ritonavir (RTV) plus emtricitabine (FTC)/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
224020|NCT01475838|P1|Participant Flow|Stribild|Participants switched from their baseline treatment regimen to Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) single-tablet regimen (STR) once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
224021|NCT01475838|O2|Outcome|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
224022|NCT01475838|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
224389|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
224023|NCT01475838|O2|Outcome|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
224024|NCT01475838|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
224025|NCT01475838|O2|Outcome|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
224026|NCT01475838|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
224027|NCT01475838|O2|Outcome|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
224028|NCT01475838|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
224029|NCT01475838|E3|Reported Event|All Stribild|Adverse events for this reporting group include those occurring in participants while receiving Stribild in the randomized and extension phases.
224030|NCT01475838|E2|Reported Event|PI+RTV+FTC/TDF|"Adverse events for this reporting group include those occurring in participants receiving PI+RTV+FTC/TDF in the randomized phase.~Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase."
224031|NCT01475838|E1|Reported Event|Stribild|"Adverse events for this reporting group include those occurring in participants receiving Stribild in the randomized phase.~Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase."
224032|NCT01475734|B3|Baseline|Total|Total of all reporting groups
224033|NCT01475734|B2|Baseline|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224034|NCT01475734|B1|Baseline|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224035|NCT01475734|P2|Participant Flow|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224036|NCT01475734|P1|Participant Flow|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224037|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224038|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224039|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224040|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224041|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224042|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224043|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
261419|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
224044|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224045|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224046|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224047|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224048|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224049|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224050|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224051|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224052|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224053|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224054|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224055|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224056|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224057|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224058|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224059|NCT01475734|E2|Reported Event|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224060|NCT01475734|E1|Reported Event|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
224061|NCT01475721|B3|Baseline|Total|Total of all reporting groups
224062|NCT01475721|B2|Baseline|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
224119|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224063|NCT01475721|B1|Baseline|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
224064|NCT01475721|P2|Participant Flow|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
224065|NCT01475721|P1|Participant Flow|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
224066|NCT01475721|O2|Outcome|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
224067|NCT01475721|O1|Outcome|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
224068|NCT01475721|O2|Outcome|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
224069|NCT01475721|O1|Outcome|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
224070|NCT01475721|O2|Outcome|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
224071|NCT01475721|O1|Outcome|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
224072|NCT01475721|O2|Outcome|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
224073|NCT01475721|O1|Outcome|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
224074|NCT01475721|O2|Outcome|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
224075|NCT01475721|O1|Outcome|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
224076|NCT01475721|E2|Reported Event|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
224077|NCT01475721|E1|Reported Event|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
224078|NCT01475487|B3|Baseline|Total|Total of all reporting groups
224079|NCT01475487|B2|Baseline|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy~Utrasound guided cricothyrotomy: Utrasound guided cricothyrotomy"
224080|NCT01475487|B1|Baseline|Cricothyrotomy Using Digital Palpation|"Group-1 will perform Cricothyrotomy using conventional digital palpation technique~Utrasound guided cricothyrotomy: Utrasound guided cricothyrotomy"
224090|NCT01475487|O1|Outcome|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique~The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
224240|NCT01475253|B4|Baseline|Total|Total of all reporting groups
224081|NCT01475487|P2|Participant Flow|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.~The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver’s neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient’s right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
224082|NCT01475487|P1|Participant Flow|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique~The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
224083|NCT01475487|O2|Outcome|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.~The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver’s neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient’s right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
224084|NCT01475487|O1|Outcome|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique~The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
224085|NCT01475487|O2|Outcome|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.~The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver’s neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient’s right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
224086|NCT01475487|O1|Outcome|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique~The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
224087|NCT01475487|O2|Outcome|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.~The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver’s neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient’s right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
224088|NCT01475487|O1|Outcome|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique~The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
224089|NCT01475487|O2|Outcome|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.~The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver’s neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient’s right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
224118|NCT01475461|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224294|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
224091|NCT01475487|E2|Reported Event|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.~The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver’s neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient’s right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
224092|NCT01475487|E1|Reported Event|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique~The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
224093|NCT01475474|B1|Baseline|Renew Insert for Management of Accidental Bowel Leakage|
224094|NCT01475474|P1|Participant Flow|Renew Insert for Management of Accidental Bowel Leakage|The Renew Insert is designed for self-insertion to seal and help prevent involuntary leakage of stool from the rectum. The Insert is designed for single use and consists of two components: a soft, easily deformable silicone insert and a flexible plastic fingertip applicator. After self insertion into the anal canal the Insert is expelled with voluntary bowel movement or if desired, manually removed by the user.
224095|NCT01475474|O1|Outcome|Modified Intent to Treat Cohort (MITT)|Modified Intent-to-Treat cohort included all subjects who completed at least one week of Insert use during the 12 Week Treatment Period.
224096|NCT01475474|O1|Outcome|Modified Intent-To-Treat Cohort|Modified Intent-to-Treat cohort included all subjects who completed week one and up to week 12 during the 12-Week Treatment Period.
224097|NCT01475474|E1|Reported Event|Intent-to-treat (ITT) Cohort|Subjects who used the Renew Insert.
224098|NCT01475461|B7|Baseline|Total|Total of all reporting groups
224099|NCT01475461|B6|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224100|NCT01475461|B5|Baseline|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224101|NCT01475461|B4|Baseline|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224102|NCT01475461|B3|Baseline|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224103|NCT01475461|B2|Baseline|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224104|NCT01475461|B1|Baseline|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224105|NCT01475461|P7|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224106|NCT01475461|P6|Participant Flow|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224107|NCT01475461|P5|Participant Flow|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224108|NCT01475461|P4|Participant Flow|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224109|NCT01475461|P3|Participant Flow|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224110|NCT01475461|P2|Participant Flow|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224111|NCT01475461|P1|Participant Flow|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
224112|NCT01475461|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224113|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224114|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224115|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224116|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224117|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224295|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
224120|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224121|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224122|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224123|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224124|NCT01475461|O7|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224125|NCT01475461|O6|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224126|NCT01475461|O5|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224127|NCT01475461|O4|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224128|NCT01475461|O3|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224129|NCT01475461|O2|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224130|NCT01475461|O1|Outcome|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
224131|NCT01475461|O7|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally tablet once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224132|NCT01475461|O6|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224133|NCT01475461|O5|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224134|NCT01475461|O4|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224135|NCT01475461|O3|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224136|NCT01475461|O2|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224137|NCT01475461|O1|Outcome|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
224138|NCT01475461|O7|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally tablet once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224139|NCT01475461|O6|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224140|NCT01475461|O5|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224141|NCT01475461|O4|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224142|NCT01475461|O3|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224143|NCT01475461|O2|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224144|NCT01475461|O1|Outcome|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
224145|NCT01475461|O6|Outcome|Sitagliptin|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224146|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224147|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224148|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224149|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224150|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
261420|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
224151|NCT01475461|O6|Outcome|Sitagliptin|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224152|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224153|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224154|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224155|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224156|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224157|NCT01475461|O6|Outcome|Sitagliptin|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224158|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224159|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224160|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224161|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224162|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224163|NCT01475461|O6|Outcome|Sitagliptin|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224164|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224165|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224166|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224167|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224168|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224169|NCT01475461|O6|Outcome|Sitagliptin|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224170|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224171|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224172|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224173|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224174|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224175|NCT01475461|O6|Outcome|Sitagliptin|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224176|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224177|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224178|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224179|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224180|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224181|NCT01475461|E7|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally tablet once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224182|NCT01475461|E6|Reported Event|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224183|NCT01475461|E5|Reported Event|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224184|NCT01475461|E4|Reported Event|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224185|NCT01475461|E3|Reported Event|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
224186|NCT01475461|E2|Reported Event|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
224187|NCT01475461|E1|Reported Event|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
224188|NCT01475331|B3|Baseline|Total|Total of all reporting groups
224189|NCT01475331|B2|Baseline|Study Group|"Normal Saline: Cysts will be lavaged for 3-5 minutes with normal saline~Chemotherapy: Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine."
224190|NCT01475331|B1|Baseline|Control Group|"Ethanol: Cysts will be lavaged for 3-5 minutes with 80% EtOH~Chemotherapy: Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine."
224191|NCT01475331|P2|Participant Flow|Study Group|"Cyst will be lavaged for 3-5 minutes with Normal Saline .. Following lavage with Normal Saline, The cyst will be infused with an admixture of(Paclitaxel/ Gemcitabine) 3mg/ml paclitaxel and 19mg/ml gemcitabine.~Normal Saline: Cysts will be lavaged for 3-5 minutes with normal saline~Chemotherapy: Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine."
224192|NCT01475331|P1|Participant Flow|Control Group|"Cyst will be lavaged for 3-5 minutes with Ethanol (alcohol 80%). Following lavage with Ethanol (alcohol 80%), The cyst will be infused with an admixture of(Paclitaxel/ Gemcitabine) 3mg/ml paclitaxel and 19mg/ml gemcitabine.~Ethanol: Cysts will be lavaged for 3-5 minutes with 80% EtOH~Chemotherapy: Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine."
224193|NCT01475331|O2|Outcome|Study Group|"Normal Saline: Cysts will be lavaged for 3-5 minutes with normal saline~Chemotherapy: Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine."
224194|NCT01475331|O1|Outcome|Control Group|"Ethanol: Cysts will be lavaged for 3-5 minutes with 80% EtOH~Chemotherapy: Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine."
224195|NCT01475331|E2|Reported Event|Study Group|"Cyst will be lavaged for 3-5 minutes with Normal Saline .. Following lavage with Normal Saline, The cyst will be infused with an admixture of(Paclitaxel/ Gemcitabine) 3mg/ml paclitaxel and 19mg/ml gemcitabine.~Normal Saline: Cysts will be lavaged for 3-5 minutes with normal saline~Chemotherapy: Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine."
224196|NCT01475331|E1|Reported Event|Control Group|"Cyst will be lavaged for 3-5 minutes with Ethanol (alcohol 80%). Following lavage with Ethanol (alcohol 80%), The cyst will be infused with an admixture of(Paclitaxel/ Gemcitabine) 3mg/ml paclitaxel and 19mg/ml gemcitabine.~Ethanol: Cysts will be lavaged for 3-5 minutes with 80% EtOH~Chemotherapy: Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine."
224197|NCT01475305|B3|Baseline|Total|Total of all reporting groups
224198|NCT01475305|B2|Baseline|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224199|NCT01475305|B1|Baseline|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
224200|NCT01475305|P2|Participant Flow|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224201|NCT01475305|P1|Participant Flow|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
224202|NCT01475305|O2|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224203|NCT01475305|O1|Outcome|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
224204|NCT01475305|O2|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224205|NCT01475305|O1|Outcome|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
224206|NCT01475305|O2|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224207|NCT01475305|O1|Outcome|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
224296|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
261421|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
224208|NCT01475305|O2|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224209|NCT01475305|O1|Outcome|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
224210|NCT01475305|O2|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224211|NCT01475305|O1|Outcome|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
224212|NCT01475305|O1|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224213|NCT01475305|O1|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224214|NCT01475305|O1|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224215|NCT01475305|O1|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224216|NCT01475305|O1|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224217|NCT01475305|O1|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224218|NCT01475305|O1|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224219|NCT01475305|O1|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224220|NCT01475305|O1|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224221|NCT01475305|O1|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224222|NCT01475305|O1|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224223|NCT01475305|O1|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224224|NCT01475305|O2|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224225|NCT01475305|O1|Outcome|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
224226|NCT01475305|O2|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224227|NCT01475305|O1|Outcome|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
224228|NCT01475305|O2|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224229|NCT01475305|O1|Outcome|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
224230|NCT01475305|O2|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224231|NCT01475305|O1|Outcome|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
224232|NCT01475305|O2|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224233|NCT01475305|O1|Outcome|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
224234|NCT01475305|O2|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224235|NCT01475305|O1|Outcome|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
224236|NCT01475305|O2|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224237|NCT01475305|O1|Outcome|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
224238|NCT01475305|E2|Reported Event|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
224239|NCT01475305|E1|Reported Event|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
224241|NCT01475253|B3|Baseline|Sham Cystoscopic Procedure-Randomized Study|"Single-blinded sham arm of subjects who underwent cystoscopic insertion and retrieval procedures without any placement or removal of investigational product or placebo."
224242|NCT01475253|B2|Baseline|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
224243|NCT01475253|B1|Baseline|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
224244|NCT01475253|P4|Participant Flow|LiRIS® 400 mg - Open Label Extension|LiRIS® 400 mg is a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine. All subjects who completed the randomized study had the option to enter the open label extension.
224245|NCT01475253|P3|Participant Flow|Sham Cystoscopic Procedure-Randomized Study|"Single-blinded sham arm of subjects who underwent cystoscopic insertion and retrieval procedures without any placement or removal of investigational product or placebo."
224246|NCT01475253|P2|Participant Flow|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
224247|NCT01475253|P1|Participant Flow|LiRIS® 400 mg - Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
224248|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
224249|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
224250|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
224251|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
224252|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
224253|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
224254|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
224255|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
224256|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
224257|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
224258|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
224259|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
224260|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
224261|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
224262|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
224263|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
261422|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
224264|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
224265|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
224266|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
224267|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
224268|NCT01475253|E4|Reported Event|LiRIS 400 mg - Open Label Extension|"LiRIS® 400 mg is a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine.~All subjects who completed the randomized study had the option to enter the open lable extension."
224269|NCT01475253|E3|Reported Event|Sham Cystoscopic Procedure - Randomized Study|"Single-blinded sham arm of subjects who underwent cystoscopic insertion and retrieval procedures without any placement or removal of investigational product or placebo."
224270|NCT01475253|E2|Reported Event|LiRIS® Placebo - Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
224271|NCT01475253|E1|Reported Event|LiRIS® 400 mg - Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
224272|NCT01475214|B4|Baseline|Total|Total of all reporting groups
224273|NCT01475214|B3|Baseline|Inactive Placebo Capsule|"microcrystalline cellulose~placebo: microcrystalline cellulose"
224274|NCT01475214|B2|Baseline|Potassium Bicarbonate Higher Dose|"potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
224275|NCT01475214|B1|Baseline|Potassium Bicarbonate Low Dose|"potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
224276|NCT01475214|P3|Participant Flow|Inactive Capsule|"microcrystalline cellulose~placebo: microcrystalline cellulose"
224277|NCT01475214|P2|Participant Flow|Potassium Bicarbonate Higher Dose|"potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
224278|NCT01475214|P1|Participant Flow|Potassium Bicarbonate Low Dose|"potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
224279|NCT01475214|O3|Outcome|Inactive Capsule|"microcrystalline cellulose~placebo: microcrystalline cellulose"
224280|NCT01475214|O2|Outcome|Potassium Bicarbonate Higher Dose|"potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
224281|NCT01475214|O1|Outcome|Potassium Bicarbonate Low Dose|"potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
224282|NCT01475214|O3|Outcome|Inactive Placebo Capsule|"microcrystalline cellulose~placebo: microcrystalline cellulose"
224283|NCT01475214|O2|Outcome|Potassium Bicarbonate Higher Dose|"potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
224284|NCT01475214|O1|Outcome|Potassium Bicarbonate Low Dose|"potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
224285|NCT01475214|E3|Reported Event|Inactive Capsule|"microcrystalline cellulose~placebo: microcrystalline cellulose"
224286|NCT01475214|E2|Reported Event|Potassium Bicarbonate Higher Dose|"potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
224287|NCT01475214|E1|Reported Event|Potassium Bicarbonate Low Dose|"potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
224288|NCT01475175|B1|Baseline|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
224289|NCT01475175|P1|Participant Flow|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
224290|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
224291|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
224292|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
224293|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
224302|NCT01475097|B1|Baseline|Iodixanol 320mgI/mL|Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
224303|NCT01475097|P2|Participant Flow|Iopamidol 370mgI/mL|Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
224304|NCT01475097|P1|Participant Flow|Iodixanol 320mgI/mL|Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
224305|NCT01475097|O2|Outcome|Iopamidol 370mgI/mL|Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
224306|NCT01475097|O1|Outcome|Iodixanol 320mgI/mL|Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
224307|NCT01475097|O2|Outcome|Iopamidol 370mgI/mL|Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
224308|NCT01475097|O1|Outcome|Iodixanol 320mgI/mL|Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
224309|NCT01475097|E2|Reported Event|Iopamidol 370mgI/mL|Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
224310|NCT01475097|E1|Reported Event|Iodixanol 320mgI/mL|Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
224311|NCT01475071|B1|Baseline|All Subjects Enrolled|Intra-individual Comparison: all subjects have received Metvix and daylight photodynamic therapy on one side and Metvix and conventional photodynamic therapy on the other side
224312|NCT01475071|P1|Participant Flow|All Subjects Enrolled|Intra-individual Comparison: all subjects have received Metvix and daylight photodynamic therapy on one side and Metvix and conventional photodynamic therapy on the other side
224313|NCT01475071|O2|Outcome|Metvix and Lamp|Metvix and conventional Phototodynamic Therapy
224314|NCT01475071|O1|Outcome|Metvix and Daylight|Metvix and daylight Photodynamic Therapy
224315|NCT01475071|O2|Outcome|Metvix and Lamp|Metvix and conventional Phototodynamic Therapy
224316|NCT01475071|O1|Outcome|Metvix and Daylight|Metvix and daylight Photodynamic Therapy
224317|NCT01475071|E2|Reported Event|Metvix and Lamp|Metvix and conventional Phototodynamic Therapy
224318|NCT01475071|E1|Reported Event|Metvix and Daylight|Metvix and daylight Photodynamic Therapy
224319|NCT01474993|B3|Baseline|Total|Total of all reporting groups
224320|NCT01474993|B2|Baseline|Sulforaphane-rich Broccoli Sprout Extract|29 subjects were randomized to receive sulforaphane.
224321|NCT01474993|B1|Baseline|Placebo|15 participants were randomized to placebo.
224322|NCT01474993|P2|Participant Flow|Sulforaphane-rich Broccoli Sprout Extract|"29 subjects were randomized to receive sulforaphane-rich Broccoli Sprout Extract. Of these, 2 were lost to follow up and 1 discontinued intervention. 26 sulforaphane participants completed the study.~Sulforaphane-rich Broccoli Sprout Extract: The medication was supplied and dispensed as No.1 size gelcaps (each gelcap containing ~ 250 mg sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of sulforaphane). The dosage of sulforaphane depended on subject's body weight:~Subjects with body weight less than 101 lbs will receive ~ 50 micromol sulforaphane per day (1 gelcap to be taken once a day)~Subjects with body weight 101 lbs to 199 lbs will receive ~ 100 micromol sulforaphane per day (2 gelcaps to be taken once a day)~Subjects with bidy weight > 199 lbs will receive ~ 150 micromol sulforaphane per day (3 gelcaps to be taken once a day)"
224323|NCT01474993|P1|Participant Flow|Placebo|15 participants were randomized to placebo (Gelcaps identical in appearance to that of active medication and containing microcrystalline cellulose).One participant in placebo group dropped out before starting study drug. 14 participants completed the study.
224324|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
224325|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
224326|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
224327|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
224390|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
224391|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
224392|NCT01474876|E1|Reported Event|Overall Study Population|Participants who received adalimumab treatment
224328|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
224329|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
224330|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
224331|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
224332|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
224333|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
224334|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
224335|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
224336|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
224337|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
224338|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
224393|NCT01474863|B4|Baseline|Total|Total of all reporting groups
224339|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
224340|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
224341|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
224342|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient’s body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 – 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
224343|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient’s body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 – 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
224344|NCT01474993|E2|Reported Event|Sulforaphane-rich Broccoli Sprout Extract|29 subjects were randomized to receive sulforaphane-rich Broccoli Sprout Extract. Of these, 2 were lost to follow up and 1 discontinued intervention. 26 sulforaphane participants completed the study and were analyzed.
224345|NCT01474993|E1|Reported Event|Placebo|15 participants were randomized to placebo. One participant in placebo group dropped out before starting study drug. 14 participants completed the study and were analyzed.
224346|NCT01474915|B3|Baseline|Total|Total of all reporting groups
224347|NCT01474915|B2|Baseline|Ondansetron|"Ondansetron is given via IV, along with an oral or IV placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy~4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction~Ondansetron : Subject will receive 4 mg of Ondansetron IV versus placebo around anesthesia induction~Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
224348|NCT01474915|B1|Baseline|Aprepitant|"Aprepitant is given orally, along with an oral or PO placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Aprepitant : Subject will receive 40 mg of Aprepitant versus placebo PO before anesthesia induction~Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction~Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
224349|NCT01474915|P2|Participant Flow|Ondansetron|"Ondansetron is given via IV, along with an oral or IV placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy~4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction~Ondansetron : Subject will receive 4 mg of Ondansetron IV versus placebo around anesthesia induction~Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
224350|NCT01474915|P1|Participant Flow|Aprepitant|"Aprepitant is given orally, along with an oral or PO placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Aprepitant : Subject will receive 40 mg of Aprepitant versus placebo PO before anesthesia induction~Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction~Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
224351|NCT01474915|O2|Outcome|Ondansetron|"Ondansetron is given via intravenous (IV), along with an oral (PO) or IV placebo depending on their group assignment for uniformity. Each patient receives three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy~4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Dexamethasone : Subject receives 10 mg of Dexamethasone IV around anesthesia induction~Ondansetron : Subject receives 4 mg of Ondansetron IV versus placebo around anesthesia induction~Promethazine : Subject receives 25 mg of Promethazine IV around anesthesia induction"
224352|NCT01474915|O1|Outcome|Aprepitant|"Aprepitant is given orally (PO), along with an oral or PO placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication plus an intravenous (IV) or oral placebo prior to induction of anesthesia.~Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Aprepitant : Subject receives 40 mg of Aprepitant versus placebo PO before anesthesia induction~Dexamethasone : Subject receives 10 mg of Dexamethasone IV around anesthesia induction~Promethazine : Subject receives 25 mg of Promethazine IV around anesthesia induction"
224353|NCT01474915|O2|Outcome|Ondansetron|"Ondansetron is given via intravenous (IV), along with an oral (PO) or IV placebo depending on their group assignment for uniformity. Each patient receives three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy~4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Dexamethasone : Subject receives 10 mg of Dexamethasone IV around anesthesia induction~Ondansetron : Subject receives 4 mg of Ondansetron IV versus placebo around anesthesia induction~Promethazine : Subject receives 25 mg of Promethazine IV around anesthesia induction"
224354|NCT01474915|O1|Outcome|Aprepitant|"Aprepitant is given orally (PO), along with an oral or PO placebo depending on their group assignment for uniformity. Each patient receives three drugs in their respective triple prophylactic medication plus an intravenous (IV) or oral placebo prior to induction of anesthesia.~Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Aprepitant : Subject receives 40 mg of Aprepitant versus placebo PO before anesthesia induction~Dexamethasone : Subject receives 10 mg of Dexamethasone IV around anesthesia induction~Promethazine : Subject receives 25 mg of Promethazine IV around anesthesia induction"
224355|NCT01474915|E2|Reported Event|Ondansetron|"Ondansetron is given via IV, along with an oral or IV placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy~4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction~Ondansetron : Subject will receive 4 mg of Ondansetron IV versus placebo around anesthesia induction~Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
224356|NCT01474915|E1|Reported Event|Aprepitant|"Aprepitant is given orally, along with an oral or PO placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Aprepitant : Subject will receive 40 mg of Aprepitant versus placebo PO before anesthesia induction~Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction~Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
224357|NCT01474876|B4|Baseline|Total|Total of all reporting groups
224358|NCT01474876|B3|Baseline|Disease State Unknown|For one participant, information regarding the underlying disease was not available
224359|NCT01474876|B2|Baseline|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
224360|NCT01474876|B1|Baseline|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
224361|NCT01474876|P3|Participant Flow|Disease State Unknown|For one participant, information regarding the underlying disease was not available
224362|NCT01474876|P2|Participant Flow|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
224363|NCT01474876|P1|Participant Flow|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
224364|NCT01474876|O1|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
224365|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
224366|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
224367|NCT01474876|O1|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
224368|NCT01474876|O1|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
224369|NCT01474876|O1|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
224370|NCT01474876|O1|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
224371|NCT01474876|O1|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
224372|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
224373|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
224374|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
224375|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
224376|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
224377|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
224378|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
224379|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
224380|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
224381|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
224382|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
224383|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
224384|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
224385|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
224386|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
224387|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
224388|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
224394|NCT01474863|B3|Baseline|High Dose Citrulline|"High Dose Citrulline~High Dose Citrulline: Initial intravenous bolus of 20mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 9mg/kg (max 700mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days"
224395|NCT01474863|B2|Baseline|Placebo|"Placebo IV infusion~Placebo: D5W IV fluids at isovolumetric rate (about 15ml/hr)"
224396|NCT01474863|B1|Baseline|Low Dose Citrulline|"Low Dose Citrulline~Low Dose Citrulline: Initial intravenous bolus of 10mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 4.5mg/kg (max 350mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days."
224397|NCT01474863|P3|Participant Flow|High Dose Citrulline|"High Dose Citrulline~High Dose Citrulline: Initial intravenous bolus of 20mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 9mg/kg (max 700mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days"
224398|NCT01474863|P2|Participant Flow|Placebo|"Placebo IV infusion~Placebo: D5W IV fluids at isovolumetric rate (about 15ml/hr)"
224399|NCT01474863|P1|Participant Flow|Low Dose Citrulline|"Low Dose Citrulline~Low Dose Citrulline: Initial intravenous bolus of 10mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 4.5mg/kg (max 350mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days."
224400|NCT01474863|O3|Outcome|High Dose Citrulline|"High Dose Citrulline~High Dose Citrulline: Initial intravenous bolus of 20mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 9mg/kg (max 700mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days"
224401|NCT01474863|O2|Outcome|Placebo|"Placebo IV infusion~Placebo: D5W IV fluids at isovolumetric rate (about 15ml/hr)"
224402|NCT01474863|O1|Outcome|Low Dose Citrulline|"Low Dose Citrulline~Low Dose Citrulline: Initial intravenous bolus of 10mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 4.5mg/kg (max 350mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days."
224403|NCT01474863|E3|Reported Event|High Dose Citrulline|"High Dose Citrulline~High Dose Citrulline: Initial intravenous bolus of 20mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 9mg/kg (max 700mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days"
224404|NCT01474863|E2|Reported Event|Placebo|"Placebo IV infusion~Placebo: D5W IV fluids at isovolumetric rate (about 15ml/hr)"
224405|NCT01474863|E1|Reported Event|Low Dose Citrulline|"Low Dose Citrulline~Low Dose Citrulline: Initial intravenous bolus of 10mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 4.5mg/kg (max 350mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days."
224406|NCT01474772|B3|Baseline|Total|Total of all reporting groups
224407|NCT01474772|B2|Baseline|Placebo/Pregabalin|Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (2 week dose titration [starting dose: 150 mg/day] and 4 weeks fixed dose [150 - 300 mg/day]). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224408|NCT01474772|B1|Baseline|Pregabalin/Placebo|Participants were randomized to double-blind treatment with pregabalin for 6 weeks (2 week dose titration [starting dose: 150 mg/day] and 4 weeks fixed dose [150 - 300 mg/day]) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224409|NCT01474772|P2|Participant Flow|Placebo/Pregablin|Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (2 week dose titration [starting dose: 150 mg/day] and 4 weeks fixed dose [150 - 300 mg/day]). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224410|NCT01474772|P1|Participant Flow|Pregabalin/Placebo|Participants were randomized to double-blind treatment with pregabalin for 6 weeks (2 week dose titration [starting dose: 150 mg/day] and 4 weeks fixed dose [150 - 300 mg/day]) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224411|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224412|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224546|NCT01474681|O3|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
224547|NCT01474681|O2|Outcome|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
225448|NCT01472939|E2|Reported Event|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
224413|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224414|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224415|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224416|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224417|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224418|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224419|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224420|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224421|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224422|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224423|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224548|NCT01474681|O1|Outcome|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
224549|NCT01474681|O2|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
224424|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224425|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224426|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224427|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224428|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224429|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224430|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224431|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224432|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224433|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224434|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224550|NCT01474681|O1|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
224551|NCT01474681|O4|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
224435|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224436|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224437|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224438|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224439|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224440|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224441|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224442|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224443|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224444|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224445|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224552|NCT01474681|O3|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
224553|NCT01474681|O2|Outcome|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
224446|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224447|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224448|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224449|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224450|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224451|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224452|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224453|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224454|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224455|NCT01474772|E2|Reported Event|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224456|NCT01474772|E1|Reported Event|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
224457|NCT01474746|B3|Baseline|Total|Total of all reporting groups
224554|NCT01474681|O1|Outcome|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
224458|NCT01474746|B2|Baseline|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224459|NCT01474746|B1|Baseline|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224460|NCT01474746|P2|Participant Flow|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224461|NCT01474746|P1|Participant Flow|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224462|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224463|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224464|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224465|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224466|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224467|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224468|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224469|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224470|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224471|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224555|NCT01474681|O4|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
261423|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
224472|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224473|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224474|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224475|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224476|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224477|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224478|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224479|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224480|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224481|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224482|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224483|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224484|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224485|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224556|NCT01474681|O3|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
227247|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
224486|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224487|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224488|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224489|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224490|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224491|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224492|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224493|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224494|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224495|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224496|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224497|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224498|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224499|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224557|NCT01474681|O2|Outcome|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
261424|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
224500|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224501|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224502|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224503|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224504|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224505|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224506|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224507|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224508|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224509|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224510|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224511|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224512|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224513|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224558|NCT01474681|O1|Outcome|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
229011|NCT01461369|O2|Outcome|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
224514|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224515|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224516|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224517|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224518|NCT01474746|O2|Outcome|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224519|NCT01474746|O1|Outcome|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224520|NCT01474746|E2|Reported Event|Active|"This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.~Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months."
224521|NCT01474746|E1|Reported Event|Placebo|"This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.~Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months."
224522|NCT01474681|B3|Baseline|Total|Total of all reporting groups
224523|NCT01474681|B2|Baseline|DUCBT|Double umbilical cord blood transplant (DUCBT) This is the combination of the DUCBT<18 yrs and DUCBT >= 18 yrs
224524|NCT01474681|B1|Baseline|SUCBT|Single umbilical cord blood transplant (SUCBT) This is the combination of the SUCBT<18 yrs and SUCBT >= 18 yrs
224525|NCT01474681|P4|Participant Flow|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
224526|NCT01474681|P3|Participant Flow|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
224527|NCT01474681|P2|Participant Flow|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
224528|NCT01474681|P1|Participant Flow|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
224529|NCT01474681|O4|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
224530|NCT01474681|O3|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
224531|NCT01474681|O2|Outcome|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
224532|NCT01474681|O1|Outcome|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
224533|NCT01474681|O4|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
224534|NCT01474681|O3|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
224535|NCT01474681|O2|Outcome|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
224536|NCT01474681|O1|Outcome|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
224537|NCT01474681|O4|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
224538|NCT01474681|O3|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
224539|NCT01474681|O2|Outcome|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
224540|NCT01474681|O1|Outcome|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
224541|NCT01474681|O4|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
224542|NCT01474681|O3|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
224543|NCT01474681|O2|Outcome|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
224544|NCT01474681|O1|Outcome|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
224545|NCT01474681|O4|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
224559|NCT01474681|O4|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
224560|NCT01474681|O3|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
224561|NCT01474681|O2|Outcome|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
224562|NCT01474681|O1|Outcome|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
224563|NCT01474681|E6|Reported Event|DUCBT|Double umbilical cord blood transplant (DUCBT) This is the combination of the DUCBT<18 yrs and DUCBT >= 18 yrs
224564|NCT01474681|E5|Reported Event|SUCBT|Single umbilical cord blood transplant (SUCBT) This is the combination of the SUCBT<18 yrs and SUCBT >= 18 yrs
224565|NCT01474681|E4|Reported Event|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
224566|NCT01474681|E3|Reported Event|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
224567|NCT01474681|E2|Reported Event|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
224568|NCT01474681|E1|Reported Event|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
224569|NCT01474590|B3|Baseline|Total|Total of all reporting groups
224570|NCT01474590|B2|Baseline|Isotretinoin + Vehicle Gel|Isotretinoin + vehicle gel: Vehicle gel: topical to the face, once daily in the evening Isotretinoin: oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.
224571|NCT01474590|B1|Baseline|Epiduo/Tactuo + Doxycycline 200mg|Epiduo/Tactuo + doxycycline 200mg: Epiduo gel: topical to the face, once daily in the evening Doxycycline: oral, 2 capsules a day. The capsules should be taken with a glass of water and with food either as a single dose or in two divided doses during the day.
224572|NCT01474590|P2|Participant Flow|Isotretinoin + Vehicle Gel|Isotretinoin + vehicle gel: Vehicle gel: topical to the face, once daily in the evening Isotretinoin: oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.
224573|NCT01474590|P1|Participant Flow|Epiduo/Tactuo + Doxycycline 200mg|Epiduo/Tactuo + doxycycline 200mg: Epiduo gel: topical to the face, once daily in the evening Doxycycline: oral, 2 capsules a day. The capsules should be taken with a glass of water and with food either as a single dose or in two divided doses during the day.
224574|NCT01474590|O2|Outcome|Isotretinoin + Vehicle Gel|Isotretinoin + vehicle gel: Vehicle gel: topical to the face, once daily in the evening Isotretinoin: oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.
224575|NCT01474590|O1|Outcome|Epiduo/Tactuo + Doxycycline 200mg|Epiduo/Tactuo + doxycycline 200mg: Epiduo gel: topical to the face, once daily in the evening Doxycycline: oral, 2 capsules a day. The capsules should be taken with a glass of water and with food either as a single dose or in two divided doses during the day.
224576|NCT01474590|E2|Reported Event|Isotretinoin + Vehicle Gel|Isotretinoin + vehicle gel: Vehicle gel: topical to the face, once daily in the evening Isotretinoin: oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.
224577|NCT01474590|E1|Reported Event|Epiduo/Tactuo + Doxycycline 200mg|Epiduo/Tactuo + doxycycline 200mg: Epiduo gel: topical to the face, once daily in the evening Doxycycline: oral, 2 capsules a day. The capsules should be taken with a glass of water and with food either as a single dose or in two divided doses during the day.
224578|NCT01474551|B1|Baseline|Vemurafenib|"This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.~Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long."
224579|NCT01474551|P1|Participant Flow|Vemurafenib|"This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.~Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long."
224580|NCT01474551|O1|Outcome|Vemurafenib|"This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.~Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long."
224581|NCT01474551|E1|Reported Event|Vemurafenib|"This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.~Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long."
224582|NCT01474538|B3|Baseline|Total|Total of all reporting groups
224583|NCT01474538|B2|Baseline|Insulin Aspart / Insulin Lispro|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1, followed by insulin lispro (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
224584|NCT01474538|B1|Baseline|Insulin Lispro / Insulin Aspart|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1, followed by insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
224585|NCT01474538|P2|Participant Flow|Insulin Aspart / Insulin Lispro|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1, followed by insulin lispro (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
224586|NCT01474538|P1|Participant Flow|Insulin Lispro / Insulin Aspart|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1, followed by insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
224587|NCT01474538|O2|Outcome|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
224588|NCT01474538|O1|Outcome|Insulin Lispro|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
224589|NCT01474538|O2|Outcome|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
224590|NCT01474538|O1|Outcome|Insulin Lispro|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
224591|NCT01474538|O2|Outcome|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
224592|NCT01474538|O1|Outcome|Insulin Lispro|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
224593|NCT01474538|O2|Outcome|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
224594|NCT01474538|O1|Outcome|Insulin Lispro|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
224595|NCT01474538|O2|Outcome|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
224596|NCT01474538|O1|Outcome|Insulin Lispro|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
224597|NCT01474538|E2|Reported Event|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
224598|NCT01474538|E1|Reported Event|Insulin Lispro|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
224599|NCT01474512|B4|Baseline|Total|Total of all reporting groups
224600|NCT01474512|B3|Baseline|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W up to Week 10.
224601|NCT01474512|B2|Baseline|Ixe Q4W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W.
224602|NCT01474512|B1|Baseline|Placebo|Placebo administered as 2 SC injections Q2W up to Week 10.
224603|NCT01474512|P10|Participant Flow|Q2W Non-Resp/Q4W - Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q2W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
224604|NCT01474512|P9|Participant Flow|Ixe Q4W Non-Resp/Ixe Q4W- Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q4W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
224605|NCT01474512|P8|Participant Flow|Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
224606|NCT01474512|P7|Participant Flow|Placebo Resp/Placebo - Maintenance Period Secondary Pop|Participants who received Placebo during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
224607|NCT01474512|P6|Participant Flow|Ixe/Ixe Q4W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
224608|NCT01474512|P5|Participant Flow|Ixe/Ixe Q12W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56.
224609|NCT01474512|P4|Participant Flow|Ixe/Placebo- Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
224610|NCT01474512|P3|Participant Flow|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 4, 6, 8, and 10.
224611|NCT01474512|P2|Participant Flow|Ixe Q4W - Induction Period|160 milligrams (mg) ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10.
224612|NCT01474512|P1|Participant Flow|Placebo- Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up to Week 10.
224613|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
224614|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
224615|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
224616|NCT01474512|O4|Outcome|Ixe Q12W - Maintenance Period|80 mg ixe administered as 1 SC injection Q12W from Week 12 up to Week 60
224617|NCT01474512|O3|Outcome|Ixe Q4W - Maintenance Period|80 mg ixe administered as 1 SC injection Q4W from Week 12 up to Week 60
224618|NCT01474512|O2|Outcome|Ixe Q4W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
224619|NCT01474512|O1|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
224620|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
224621|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
224622|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
224623|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
224624|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
224625|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
224626|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
224627|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
224628|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
224629|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
224630|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
224631|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
224632|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
224633|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
224634|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
224635|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
224636|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
224637|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
224638|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
224639|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
224640|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
224641|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
224642|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
224643|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
224644|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
224645|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
224646|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
224647|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
224648|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
224649|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
224650|NCT01474512|O3|Outcome|Ixe/Q4W|Participants who received ixe (Q2W or Q4W) in Induction Period who were re-randomized at Week 12 and were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56 (Maintenance Period).
224651|NCT01474512|O2|Outcome|Ixe/Q12W|Participants who received ixe (Q2W or Q4W) in Induction Period who were re-randomized at Week 12 and were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q12W up to and including Week 56 (Maintenance Period).
224652|NCT01474512|O1|Outcome|Ixe/Placebo|Participants who received ixe (Q2W or Q4W) in Induction Period who were re-randomized at Week 12 and administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56 (Maintenance Period).
224653|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
224654|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
224655|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
224656|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
224657|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
224658|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
224659|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
224660|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
224661|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
224662|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
224663|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
224664|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
224665|NCT01474512|E11|Reported Event|Ixe Q4W - Maintenance Period Relapse Pop|Participants who relapsed (loss of response, sPGA ≥3 during Maintenance Period) were administered 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
224666|NCT01474512|E10|Reported Event|Q2W Non-Resp/Q4W - Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q2W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
224667|NCT01474512|E9|Reported Event|Ixe Q4W Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q4W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
224668|NCT01474512|E8|Reported Event|Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
224669|NCT01474512|E7|Reported Event|Placebo Resp/Placebo - Maintenance Period Secondary Pop|Participants who received Placebo during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
224670|NCT01474512|E6|Reported Event|Ixe/Ixe Q4W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
224671|NCT01474512|E5|Reported Event|Ixe/Ixe Q12W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q12W up to and including Week 56.
224672|NCT01474512|E4|Reported Event|Ixe/Placebo- Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
224673|NCT01474512|E3|Reported Event|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W up to Weeks 4, 6, 8 and 10.
224674|NCT01474512|E2|Reported Event|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W. Placebo was administered as 1 SC injection at Weeks 2, 6, and 10.
224675|NCT01474512|E1|Reported Event|Placebo - Induction Period|Placebo was administered as 2 SC injections Q2W up to Week 10.
224676|NCT01474434|B5|Baseline|Total|Total of all reporting groups
224677|NCT01474434|B4|Baseline|Part A, Cohort 2: Placebo Followed by Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by 20 mg (2 x 10-mg tablets) daily for two days
224678|NCT01474434|B3|Baseline|Part A, Cohort 2: Pradigastat (LCQ908) Followed by Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All patients who randomized to this sequence received pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment
224679|NCT01474434|B2|Baseline|Part A, Cohort 1: Placebo Followed by Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by 20 mg (2 x 10-mg tablets) daily for two days
224680|NCT01474434|B1|Baseline|Part A, Cohort 1: Pradigastat (LCQ908) Followed by Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment
224681|NCT01474434|P4|Participant Flow|Part A, Cohort 2: Placebo Followed by Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by 20 mg (2 x 10-mg tablets) daily for two days
224682|NCT01474434|P3|Participant Flow|Part A, Cohort 2: Pradigastat (LCQ908) Followed by Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All patients who randomized to this sequence received pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment
224683|NCT01474434|P2|Participant Flow|Part A, Cohort 1: Placebo Followed by Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by 20 mg (2 x 10-mg tablets) daily for two days
224684|NCT01474434|P1|Participant Flow|Part A, Cohort 1: Pradigastat (LCQ908) Followed by Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment
224685|NCT01474434|O2|Outcome|Part B: Placebo|
224686|NCT01474434|O1|Outcome|Part B: Pradigastat (LCQ908)|
224687|NCT01474434|O4|Outcome|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
224688|NCT01474434|O3|Outcome|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
224767|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
224689|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
224690|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
224691|NCT01474434|O4|Outcome|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
224692|NCT01474434|O3|Outcome|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
224693|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
224694|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
224695|NCT01474434|O4|Outcome|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
224696|NCT01474434|O3|Outcome|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
224697|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
224698|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
224699|NCT01474434|O4|Outcome|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
224700|NCT01474434|O3|Outcome|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
224701|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
224702|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
224703|NCT01474434|O2|Outcome|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
224704|NCT01474434|O1|Outcome|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
224705|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
224706|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
224707|NCT01474434|O2|Outcome|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
224708|NCT01474434|O1|Outcome|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
224709|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
224710|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
224711|NCT01474434|O2|Outcome|Part B: Placebo|
224712|NCT01474434|O1|Outcome|Part B: Pradigastat (LCQ908)|
224713|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
229012|NCT01461369|O1|Outcome|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
224714|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
224715|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
224716|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
224717|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
224718|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
224719|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
224720|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
224721|NCT01474434|E4|Reported Event|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
224722|NCT01474434|E3|Reported Event|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
224723|NCT01474434|E2|Reported Event|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
224724|NCT01474434|E1|Reported Event|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
224725|NCT01474317|B1|Baseline|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study~G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
224726|NCT01474317|P1|Participant Flow|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system.~G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
224727|NCT01474317|O1|Outcome|Intended Users of the G3 Investigational BG Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study.~G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
224728|NCT01474317|O1|Outcome|Intended Users of the G3 Investigational BG Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study.~G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
224729|NCT01474317|O1|Outcome|Intended Users of the G3 Investigational BG Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study.~G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
224730|NCT01474317|O1|Outcome|Intended Users of the G3 Investigational BG Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study.~G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
224768|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
224731|NCT01474317|E1|Reported Event|Intended Users of the G3 Investigational BG Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study.~G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
224732|NCT01474291|B3|Baseline|Total|Total of all reporting groups
224733|NCT01474291|B2|Baseline|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
224734|NCT01474291|B1|Baseline|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
224735|NCT01474291|P1|Participant Flow|All Tocilizumab|Tocilizumab (RoActemra/Actemra) administered as monotherapy or in combination with other standard of care therapy according to prescribing information and normal clinical practice.
224736|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
224737|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
224738|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
224739|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
224740|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
224741|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
224742|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
224743|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
224744|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
224745|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
224746|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
224747|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
224748|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
224749|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
224750|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
224751|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
224752|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
224753|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
224754|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
224755|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
224756|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
224757|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
224758|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
224759|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
224760|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
224761|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
224762|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
224763|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
224764|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
224765|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
224766|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
224769|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
224770|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
224771|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
224772|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
224773|NCT01474291|O1|Outcome|All Tocilizumab|Tocilizumab administered as monotherapy or in combination with other standard of care therapy according to prescribing information and normal clinical practice.
224774|NCT01474291|E2|Reported Event|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
224775|NCT01474291|E1|Reported Event|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
224776|NCT01474239|B3|Baseline|Total|Total of all reporting groups
224777|NCT01474239|B2|Baseline|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224778|NCT01474239|B1|Baseline|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224779|NCT01474239|P2|Participant Flow|Fotemustine|Participants received fotemustine 75 milligrams per square meter (mg/m^2) via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224780|NCT01474239|P1|Participant Flow|Bevacizumab|Participants received bevacizumab 10 milligrams per kilogram (mg/kg) via intravenous (IV) infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224781|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224782|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224783|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224784|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224785|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224786|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224787|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224788|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224789|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224790|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224791|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224792|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224793|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224794|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224795|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224919|NCT01474122|E2|Reported Event|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
224796|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224797|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224798|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224799|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224800|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224801|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224802|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224803|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224804|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224805|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224806|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224807|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224808|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224809|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224810|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224811|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224812|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224813|NCT01474239|E2|Reported Event|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224814|NCT01474239|E1|Reported Event|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
224815|NCT01474213|B3|Baseline|Total|Total of all reporting groups
224816|NCT01474213|B2|Baseline|Remifentanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml–1 and the TCI was adjusted by 0.5 ng ml–1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
224817|NCT01474213|B1|Baseline|Dexmedetomidine Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg–1) infused over10 min followed by a continuous infusion of 0.7 μg kg–1 h–1.
224818|NCT01474213|P2|Participant Flow|Remifentanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml–1 and the TCI was adjusted by 0.5 ng ml–1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
224819|NCT01474213|P1|Participant Flow|Dexmedetomidine Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg–1) infused over10 min followed by a continuous infusion of 0.7 μg kg–1 h–1.
224820|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
224821|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
224822|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
224823|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
224824|NCT01474213|O2|Outcome|Dexmedetomidine Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
224825|NCT01474213|O1|Outcome|Remifentanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site (had equilibrated with the plasma concentration, until the desired level of sedation was reached.
224826|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Three patients in dexmedetomidine group exhibited bradycardia(heart rate<50beats per minute) during endoscopy and intubation period.
224827|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Two patients in remifentanil group exhibited bradycardia(heart rate<50beats per minute) during endoscopy and intubation period.
224828|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
224829|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
224830|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
224831|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
224832|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
224833|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
224834|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
224835|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
224836|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
224837|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
224838|NCT01474213|E2|Reported Event|Remifentanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml–1 and the TCI was adjusted by 0.5 ng ml–1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
224839|NCT01474213|E1|Reported Event|Dexmedetomidine Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg–1) infused over10 min followed by a continuous infusion of 0.7 μg kg–1 h–1.
224840|NCT01474200|B3|Baseline|Total|Total of all reporting groups
224841|NCT01474200|B2|Baseline|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
224920|NCT01474122|E1|Reported Event|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
224921|NCT01474109|B4|Baseline|Total|Total of all reporting groups
224922|NCT01474109|B3|Baseline|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
224842|NCT01474200|B1|Baseline|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
224843|NCT01474200|P2|Participant Flow|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
224844|NCT01474200|P1|Participant Flow|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
224845|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
224846|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
224847|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
224848|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
224849|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
224850|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
224851|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
224852|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
224923|NCT01474109|B2|Baseline|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
224924|NCT01474109|B1|Baseline|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
229013|NCT01461369|O3|Outcome|Placebo|Placebo: Capsule
224853|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
224854|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
224855|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
224856|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
224857|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
224858|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
224859|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
224860|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
224861|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
224862|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
224863|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
224925|NCT01474109|P3|Participant Flow|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
224926|NCT01474109|P2|Participant Flow|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
229014|NCT01461369|O2|Outcome|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
224864|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
224865|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
224866|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
224867|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
224868|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
224869|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
224870|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
224871|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
224872|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
224873|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
224874|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
224927|NCT01474109|P1|Participant Flow|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
224928|NCT01474109|O3|Outcome|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
224929|NCT01474109|O2|Outcome|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
224875|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
224876|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
224877|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
224878|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
224879|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
224880|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
224881|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
224882|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
224883|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
224884|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
224885|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
224930|NCT01474109|O1|Outcome|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
224931|NCT01474109|O3|Outcome|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
224932|NCT01474109|O2|Outcome|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
224886|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
224887|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
224888|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
224889|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
224890|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
224891|NCT01474200|E2|Reported Event|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
224892|NCT01474200|E1|Reported Event|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
224893|NCT01474122|B4|Baseline|Total|Total of all reporting groups
224894|NCT01474122|B3|Baseline|Placebo|Patients received placebo once daily.
224895|NCT01474122|B2|Baseline|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
224896|NCT01474122|B1|Baseline|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
224897|NCT01474122|P3|Participant Flow|Placebo|Patients received placebo once daily.
224898|NCT01474122|P2|Participant Flow|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
224899|NCT01474122|P1|Participant Flow|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
224900|NCT01474122|O3|Outcome|Placebo|Patients received placebo once daily.
224901|NCT01474122|O2|Outcome|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
224902|NCT01474122|O1|Outcome|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
224903|NCT01474122|O3|Outcome|Placebo|Patients received placebo once daily.
224904|NCT01474122|O2|Outcome|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
224905|NCT01474122|O1|Outcome|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
224906|NCT01474122|O3|Outcome|Placebo|Patients received placebo once daily.
224907|NCT01474122|O2|Outcome|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
224908|NCT01474122|O1|Outcome|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
224909|NCT01474122|O3|Outcome|Placebo|Patients received placebo once daily.
224910|NCT01474122|O2|Outcome|Macitentan 10mg|Patients received macitentan 10mg once daily.
224911|NCT01474122|O1|Outcome|Macitentan 3mg|Patients received macitentan 3mg once daily.
224912|NCT01474122|O3|Outcome|Placebo|Patients received placebo once daily.
224913|NCT01474122|O2|Outcome|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
224914|NCT01474122|O1|Outcome|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
224915|NCT01474122|O3|Outcome|Placebo|Patients received placebo once daily.
224916|NCT01474122|O2|Outcome|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
224917|NCT01474122|O1|Outcome|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
224918|NCT01474122|E3|Reported Event|Placebo|Patients received placebo once daily.
224933|NCT01474109|O1|Outcome|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
224934|NCT01474109|O3|Outcome|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
224935|NCT01474109|O2|Outcome|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
224936|NCT01474109|O1|Outcome|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
224937|NCT01474109|O3|Outcome|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
224938|NCT01474109|O2|Outcome|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
224939|NCT01474109|O1|Outcome|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
224940|NCT01474109|O3|Outcome|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
224941|NCT01474109|O2|Outcome|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
224942|NCT01474109|O1|Outcome|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
224943|NCT01474109|O3|Outcome|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
224944|NCT01474109|O2|Outcome|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
224945|NCT01474109|O1|Outcome|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
224946|NCT01474109|E3|Reported Event|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
224947|NCT01474109|E2|Reported Event|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
224948|NCT01474109|E1|Reported Event|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
224949|NCT01473992|B3|Baseline|Total|Total of all reporting groups
224950|NCT01473992|B2|Baseline|Non Amputee Control Group|non-amputee healty controls
224951|NCT01473992|B1|Baseline|Entire Study Population|Includes groups randomized to receive Otto Bock C-Leg (prosthetic knee 1), amputees' preferred prosthetic knee, first and Otto Bock Genium (prosthetic knee 2), the study knee, first.
224952|NCT01473992|P3|Participant Flow|Control (Non-amputees)|Non-amputee control group
224953|NCT01473992|P2|Participant Flow|Prosthetic Knee 2 Then Prosthetic Knee 1|Experimental knee (Otto Bock Genium: Study knee) then subjects' preferred knee (C-Leg).
224954|NCT01473992|P1|Participant Flow|Prosthetic Knee 1 Then Prosthetic Knee 2|Otto Bock C-Leg: Amputees' preferred prosthetic knee then experimental knee (Genium).
224955|NCT01473992|O3|Outcome|Non Amputee Control Group|healthy, non-amputee control group
224956|NCT01473992|O2|Outcome|Prosthetic Knee 2|Otto Bock Genium: Study knee.
224957|NCT01473992|O1|Outcome|Prosthetic Knee 1|Otto Bock C-Leg: Amputees' preferred prosthetic knee.
224958|NCT01473992|O2|Outcome|Prosthetic Knee 2|Otto Bock Genium: Study knee.
224959|NCT01473992|O1|Outcome|Prosthetic Knee 1|Otto Bock C-Leg: Amputees' preferred prosthetic knee.
224960|NCT01473992|O3|Outcome|Non Amputee Control Group|healthy, non-amputee controls
224961|NCT01473992|O2|Outcome|Prosthetic Knee 2|Otto Bock Genium: Study knee.
224962|NCT01473992|O1|Outcome|Prosthetic Knee 1|Otto Bock C-Leg: Amputees' preferred prosthetic knee.
224963|NCT01473992|O3|Outcome|Non Amputee Control Group|healthy, non-amputee controls
224964|NCT01473992|O2|Outcome|Prosthetic Knee 2|Otto Bock Genium: Study knee.
224965|NCT01473992|O1|Outcome|Prosthetic Knee 1|Otto Bock C-Leg: Amputees' preferred prosthetic knee.
224966|NCT01473992|E2|Reported Event|Prosthetic Knee 2|Otto Bock Genium: Study knee.
224967|NCT01473992|E1|Reported Event|Prosthetic Knee 1|Otto Bock C-Leg: Amputees' preferred prosthetic knee.
224968|NCT01473953|B6|Baseline|Total|Total of all reporting groups
224969|NCT01473953|B5|Baseline|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
224970|NCT01473953|B4|Baseline|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
224971|NCT01473953|B3|Baseline|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
224972|NCT01473953|B2|Baseline|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
224973|NCT01473953|B1|Baseline|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
224974|NCT01473953|P5|Participant Flow|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
224975|NCT01473953|P4|Participant Flow|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
224976|NCT01473953|P3|Participant Flow|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
224977|NCT01473953|P2|Participant Flow|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
224978|NCT01473953|P1|Participant Flow|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
224979|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
224980|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
224981|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
224982|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
224983|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
224984|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
224985|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
261425|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
224986|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
224987|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
224988|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
224989|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
224990|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
224991|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
224992|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
224993|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
224994|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
224995|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
224996|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
224997|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
224998|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
224999|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
225000|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
225001|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
225002|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
225003|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
225004|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
225005|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
225006|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
225007|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
225008|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
225009|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
225010|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
225011|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
225012|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
225013|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
225014|NCT01473953|E5|Reported Event|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
225015|NCT01473953|E4|Reported Event|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
225016|NCT01473953|E3|Reported Event|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
225017|NCT01473953|E2|Reported Event|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
225018|NCT01473953|E1|Reported Event|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
225019|NCT01473836|B1|Baseline|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
225020|NCT01473836|P1|Participant Flow|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
225021|NCT01473836|O1|Outcome|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
225022|NCT01473836|O1|Outcome|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
225052|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225303|NCT01473394|O1|Outcome|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
225023|NCT01473836|O1|Outcome|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
225024|NCT01473836|O1|Outcome|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
225025|NCT01473836|O1|Outcome|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
225026|NCT01473836|O1|Outcome|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
225027|NCT01473836|E1|Reported Event|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
225028|NCT01473758|B3|Baseline|Total|Total of all reporting groups
225029|NCT01473758|B2|Baseline|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225030|NCT01473758|B1|Baseline|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225031|NCT01473758|P4|Participant Flow|Placebo (Cycle 2)|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations in Cycle 2.
225032|NCT01473758|P3|Participant Flow|Roflumilast 500 µg (Cycle 2)|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations in Cycle 2.
225033|NCT01473758|P2|Participant Flow|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Eligible participants were re-randomized to receive either roflumilast 500 μg or placebo for 4 weeks in Cycle 2.
225034|NCT01473758|P1|Participant Flow|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations. Eligible participants were re-randomized to receive either roflumilast 500 μg or placebo for 4 weeks in Cycle 2.
225035|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225036|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225037|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225038|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225039|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225040|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225041|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225042|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225043|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225044|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225045|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225046|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225047|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225048|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225049|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225050|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225051|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225053|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225054|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225055|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225056|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225057|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225058|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225059|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225060|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225061|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225062|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225063|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225064|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225065|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225066|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225067|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225068|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225069|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225070|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225071|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225072|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225073|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225074|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225075|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225076|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225077|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225078|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225079|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225080|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225081|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225082|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225083|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225084|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225085|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225086|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225087|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225449|NCT01472939|E1|Reported Event|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
225088|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225089|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225090|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225091|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225092|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225093|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225094|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225095|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225096|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225097|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225098|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225099|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225100|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225101|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225102|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225103|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225104|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225105|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225106|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225107|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225108|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225109|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225110|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225111|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225112|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225113|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225114|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225115|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225116|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225117|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225118|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225119|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225120|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225121|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225122|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
226207|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
225123|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225124|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225125|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225126|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225127|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225128|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225129|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225130|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225131|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225132|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225133|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225134|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225135|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225136|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225137|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225138|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225139|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225140|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225141|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225142|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225143|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225144|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225145|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225146|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225147|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225148|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225149|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225150|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
225151|NCT01473758|E4|Reported Event|Placebo (Extended Approach)|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Extended Approach Arm includes all participants who received treatment in Cycle 1 and those participants who were re-randomized and received treatment in Cycle 2.
225152|NCT01473758|E3|Reported Event|Roflumilast 500 µg (Extended Approach)|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Extended Approach Arm includes all participants who received treatment in Cycle 1 and those participants who were re-randomized and received treatment in Cycle 2.
225153|NCT01473758|E2|Reported Event|Placebo (Initial Approach)|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Initial Approach Arm includes all participants who received treatment in Cycle 1.
225154|NCT01473758|E1|Reported Event|Roflumilast 500 μg (Initial Approach)|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Initial Approach Arm includes all participants who received treatment in Cycle 1.
225155|NCT01473745|B3|Baseline|Total|Total of all reporting groups
225232|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225156|NCT01473745|B2|Baseline|Conventional Alar Base Cinch Suture|"conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) intra-orally~conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy."
225157|NCT01473745|B1|Baseline|Modified Alar Cinch Suture|"modified extraoral alar cinch suture techniques suture from intraoral to extraoral and from one side to another side~modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy."
225158|NCT01473745|P2|Participant Flow|Modified Alar Cinch Group|Patients received modified alar base cinch technique during LeFort I osteotomy procedure.
225159|NCT01473745|P1|Participant Flow|Conventional Alar Cinch Group|Patients received conventional alar base cinch technique during LeFort I osteotomy procedure.
225160|NCT01473745|O2|Outcome|Conventional Alar Base Cinch Suture|"conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) intra-orally~conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy."
225161|NCT01473745|O1|Outcome|Modified Alar Cinch Suture|"modified extraoral alar cinch suture techniques suture from intraoral to extraoral and from one side to another side~modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy."
225162|NCT01473745|O2|Outcome|Conventional Alar Base Cinch Suture|"conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) intra-orally~conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy."
225163|NCT01473745|O1|Outcome|Modified Alar Cinch Suture|"modified extraoral alar cinch suture techniques suture from intraoral to extraoral and from one side to another side~modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy."
225164|NCT01473745|O2|Outcome|Conventional Alar Base Cinch Suture|"conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) intra-orally~conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy."
225165|NCT01473745|O1|Outcome|Modified Alar Cinch Suture|"modified extraoral alar cinch suture techniques suture from intraoral to extraoral and from one side to another side~modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy."
225166|NCT01473745|E2|Reported Event|Conventional Alar Base Cinch Suture|"conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) and nasalis muscle intra-orally~conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy."
225167|NCT01473745|E1|Reported Event|Modified Alar Cinch Suture|"modified extraoral alar cinch suture techniques suture from not only ANS and nasalis muscle, but also through the dermis layer of the alar base.~modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy."
225168|NCT01473602|B3|Baseline|Total|Total of all reporting groups
225169|NCT01473602|B2|Baseline|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225170|NCT01473602|B1|Baseline|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
225171|NCT01473602|P2|Participant Flow|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225172|NCT01473602|P1|Participant Flow|Teriparatide|Teriparatide 20 microgram (µg) once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
225173|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225174|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
225175|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225176|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
225177|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225178|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
225179|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225180|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
225181|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225182|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
225183|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225184|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
225185|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225186|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
225187|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225188|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
225189|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
226208|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
225190|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
225191|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225192|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
225193|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225194|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
225195|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225196|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
225197|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225198|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
225199|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225200|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
225201|NCT01473602|E4|Reported Event|Teriparatide Follow-up|Follow-up after teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
225202|NCT01473602|E3|Reported Event|Placebo Follow-up|Follow-up after placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225203|NCT01473602|E2|Reported Event|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
225204|NCT01473602|E1|Reported Event|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225205|NCT01473589|B3|Baseline|Total|Total of all reporting groups
225206|NCT01473589|B2|Baseline|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225207|NCT01473589|B1|Baseline|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225208|NCT01473589|P2|Participant Flow|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225209|NCT01473589|P1|Participant Flow|Teriparatide|Teriparatide 20 micrograms (µg) administered once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
225210|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225211|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225212|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225213|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225214|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225215|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225216|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225217|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225218|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225219|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225220|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225221|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225222|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225223|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225224|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225225|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225226|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225227|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225228|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225229|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225230|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225231|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225233|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225234|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225235|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225236|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225237|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225238|NCT01473589|E4|Reported Event|Teriparatide Follow-up|Follow-up after teriparatide 20 µg once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225239|NCT01473589|E3|Reported Event|Placebo Follow-up|Follow-up after placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225240|NCT01473589|E2|Reported Event|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225241|NCT01473589|E1|Reported Event|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
225242|NCT01473563|B1|Baseline|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
225243|NCT01473563|P1|Participant Flow|Pemetrexed|Pemetrexed: 500 milligrams per meter squared (mg/m^2) administered as an intravenous (IV) infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
225244|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
225245|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
225246|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
225247|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
225248|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
225249|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
225250|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
225251|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
225252|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
225253|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
225254|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
225255|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
225278|NCT01473524|O2|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
225256|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
225257|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
225258|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
225259|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
225260|NCT01473563|E1|Reported Event|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
225261|NCT01473524|B4|Baseline|Total|Total of all reporting groups
225262|NCT01473524|B3|Baseline|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
225263|NCT01473524|B2|Baseline|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
225264|NCT01473524|B1|Baseline|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
225265|NCT01473524|P3|Participant Flow|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
225266|NCT01473524|P2|Participant Flow|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
225267|NCT01473524|P1|Participant Flow|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
225268|NCT01473524|O3|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
225269|NCT01473524|O2|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
225270|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
225271|NCT01473524|O3|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
225272|NCT01473524|O2|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
225273|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double blind-period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
225274|NCT01473524|O3|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
225275|NCT01473524|O2|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
225276|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
225277|NCT01473524|O3|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
261426|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
225279|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
225280|NCT01473524|O3|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
225281|NCT01473524|O2|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
225282|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
225283|NCT01473524|O3|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
225284|NCT01473524|O2|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
225285|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
225286|NCT01473524|O2|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
225287|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
225288|NCT01473524|O2|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
225289|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
225290|NCT01473524|O2|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
225291|NCT01473524|O1|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
225292|NCT01473524|O2|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
225293|NCT01473524|O1|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
225294|NCT01473524|E3|Reported Event|Placebo|One tablet daily for double-blind period. After completion of the 1 year double-blind period period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
225295|NCT01473524|E2|Reported Event|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1 year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
225296|NCT01473524|E1|Reported Event|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double blind-period.~After completion of the 1 year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
225297|NCT01473394|B3|Baseline|Total|Total of all reporting groups
225298|NCT01473394|B2|Baseline|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
225299|NCT01473394|B1|Baseline|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
225300|NCT01473394|P2|Participant Flow|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
225301|NCT01473394|P1|Participant Flow|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
225302|NCT01473394|O2|Outcome|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
261427|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
225304|NCT01473394|O2|Outcome|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
225305|NCT01473394|O1|Outcome|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
225306|NCT01473394|O2|Outcome|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
225307|NCT01473394|O1|Outcome|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
225308|NCT01473394|E2|Reported Event|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
225309|NCT01473394|E1|Reported Event|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
225310|NCT01473381|B5|Baseline|Total|Total of all reporting groups
225311|NCT01473381|B4|Baseline|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
225312|NCT01473381|B3|Baseline|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
225313|NCT01473381|B2|Baseline|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
225314|NCT01473381|B1|Baseline|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
225315|NCT01473381|P4|Participant Flow|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
225316|NCT01473381|P3|Participant Flow|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
225317|NCT01473381|P2|Participant Flow|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
225318|NCT01473381|P1|Participant Flow|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
225319|NCT01473381|O4|Outcome|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
225320|NCT01473381|O3|Outcome|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days
225321|NCT01473381|O2|Outcome|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
225322|NCT01473381|O1|Outcome|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
225323|NCT01473381|O4|Outcome|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
225324|NCT01473381|O3|Outcome|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
225325|NCT01473381|O2|Outcome|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
225326|NCT01473381|O1|Outcome|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
225355|NCT01473368|O2|Outcome|Antibiotic (Amoxicillin Clavulanate) During Treatment|"During treatment~Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days"
225327|NCT01473381|O4|Outcome|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
225328|NCT01473381|O3|Outcome|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
225329|NCT01473381|O2|Outcome|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
225330|NCT01473381|O1|Outcome|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
225331|NCT01473381|E4|Reported Event|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
225332|NCT01473381|E3|Reported Event|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
225333|NCT01473381|E2|Reported Event|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
225334|NCT01473381|E1|Reported Event|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
225335|NCT01473368|B5|Baseline|Total|Total of all reporting groups
225336|NCT01473368|B4|Baseline|Control|control group
225337|NCT01473368|B3|Baseline|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
225338|NCT01473368|B2|Baseline|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
225339|NCT01473368|B1|Baseline|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
225340|NCT01473368|P4|Participant Flow|Control|Control group
225341|NCT01473368|P3|Participant Flow|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
225342|NCT01473368|P2|Participant Flow|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
225343|NCT01473368|P1|Participant Flow|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
225344|NCT01473368|O7|Outcome|Prebiotic (Saccharomyces Boulardii) After Treatment|"After Treatment~Saccharomyces boulardii: 500 mg, 2 times daily for 14 days"
225345|NCT01473368|O6|Outcome|Prebiotic (Saccharomyces Boulardii) During Treatment|"During Treatment~Saccharomyces boulardii: 500 mg, 2 times daily for 14 days"
225346|NCT01473368|O5|Outcome|Core Microbiome|Core Microbiome
225347|NCT01473368|O4|Outcome|Antibiotic (Amoxicillin Clavulanate) After Treatment|"After Treatment~Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days"
225348|NCT01473368|O3|Outcome|Antibiotic (Amoxicillin Clavulanate) During Treatment|"During Treatment~Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days"
225349|NCT01473368|O2|Outcome|Combination (Prebiotic and Antibiotic) After Treatment|"After Treatment~Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily)."
225350|NCT01473368|O1|Outcome|Combination (Prebiotic and Antibiotic) During Treatment|"During Treatment~Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily)."
225351|NCT01473368|O3|Outcome|Combination (Prebiotic and Antibiotic) After Treatment|"After treatment~Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily)."
225352|NCT01473368|O2|Outcome|Combination (Prebiotic and Antibiotic) During Treatment|"During treatment~Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily)."
225353|NCT01473368|O1|Outcome|Combination (Prebiotic and Antibiotic) Before Treatment|"Before treatment~Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily)."
225354|NCT01473368|O3|Outcome|Antibiotic (Amoxicillin Clavulanate) After Treatment|"After treatment~Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days"
225437|NCT01472939|O1|Outcome|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
225356|NCT01473368|O1|Outcome|Antibiotic (Amoxicillin Clavulanate) Before Treatment|"Before treatment~Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days"
225357|NCT01473368|O3|Outcome|Prebiotic (Saccharomyces Boulardii) After Treatment|"After treatment~Saccharomyces boulardii: 500 mg, 2 times daily for 14 days"
225358|NCT01473368|O2|Outcome|Prebiotic (Saccharomyces Boulardii) During Treatment|"During treatment~Saccharomyces boulardii: 500 mg, 2 times daily for 14 days"
225359|NCT01473368|O1|Outcome|Prebiotic (Saccharomyces Boulardii) Before Treatment|"Before treatment~Saccharomyces boulardii: 500 mg, 2 times daily for 14 days"
225360|NCT01473368|O4|Outcome|Control|Control group
225361|NCT01473368|O3|Outcome|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
225362|NCT01473368|O2|Outcome|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
225363|NCT01473368|O1|Outcome|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
225364|NCT01473368|O4|Outcome|Control|Control group
225365|NCT01473368|O3|Outcome|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
225366|NCT01473368|O2|Outcome|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
225367|NCT01473368|O1|Outcome|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
225368|NCT01473368|O4|Outcome|Control|Control group
225369|NCT01473368|O3|Outcome|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
225370|NCT01473368|O2|Outcome|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
225371|NCT01473368|O1|Outcome|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
225372|NCT01473368|O3|Outcome|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
225373|NCT01473368|O2|Outcome|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
225374|NCT01473368|O1|Outcome|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
225375|NCT01473368|E4|Reported Event|Control|
225376|NCT01473368|E3|Reported Event|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
225377|NCT01473368|E2|Reported Event|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
225378|NCT01473368|E1|Reported Event|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
225379|NCT01473160|B1|Baseline|Overall Study|All enrolled participants
225380|NCT01473160|P1|Participant Flow|Overall Study|All enrolled participants
225381|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
225382|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
225383|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
225384|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
225385|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
225386|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
225387|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
225388|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
225389|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
225390|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
225391|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
225392|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
225393|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
225394|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
225395|NCT01473160|E2|Reported Event|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
225396|NCT01473160|E1|Reported Event|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
225397|NCT01472965|B3|Baseline|Total|Total of all reporting groups
225398|NCT01472965|B2|Baseline|Control (Placebo)|"Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.~heparin-saline placebo: heparin-saline placebo catheter lock therapy"
225399|NCT01472965|B1|Baseline|Treatment (Ethanol)|"Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.~ethanol: 70% ethanol catheter lock therapy"
225400|NCT01472965|P2|Participant Flow|Control (Placebo)|"Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.~heparin-saline placebo: heparin-saline placebo catheter lock therapy"
225401|NCT01472965|P1|Participant Flow|Treatment (Ethanol)|"Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.~ethanol: 70% ethanol catheter lock therapy"
225402|NCT01472965|O2|Outcome|Control (Placebo)|"Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.~heparin-saline placebo: heparin-saline placebo catheter lock therapy"
225403|NCT01472965|O1|Outcome|Treatment (Ethanol)|"Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.~ethanol: 70% ethanol catheter lock therapy"
225404|NCT01472965|O2|Outcome|Control (Placebo)|"Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.~heparin-saline placebo: heparin-saline placebo catheter lock therapy"
225405|NCT01472965|O1|Outcome|Treatment (Ethanol)|"Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.~ethanol: 70% ethanol catheter lock therapy"
225406|NCT01472965|O2|Outcome|Control (Placebo)|"Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.~heparin-saline placebo: heparin-saline placebo catheter lock therapy"
225407|NCT01472965|O1|Outcome|Treatment (Ethanol)|"Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.~ethanol: 70% ethanol catheter lock therapy"
225408|NCT01472965|O2|Outcome|Control (Placebo)|"Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.~heparin-saline placebo: heparin-saline placebo catheter lock therapy"
225409|NCT01472965|O1|Outcome|Treatment (Ethanol)|"Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.~ethanol: 70% ethanol catheter lock therapy"
225410|NCT01472965|O2|Outcome|Control (Placebo)|"Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.~heparin-saline placebo: heparin-saline placebo catheter lock therapy"
225411|NCT01472965|O1|Outcome|Treatment (Ethanol)|"Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.~ethanol: 70% ethanol catheter lock therapy"
225412|NCT01472965|O2|Outcome|Control (Placebo)|"Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.~heparin-saline placebo: heparin-saline placebo catheter lock therapy"
225413|NCT01472965|O1|Outcome|Treatment (Ethanol)|"Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.~ethanol: 70% ethanol catheter lock therapy"
225414|NCT01472965|E2|Reported Event|Control (Placebo)|"Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.~heparin-saline placebo: heparin-saline placebo catheter lock therapy"
225415|NCT01472965|E1|Reported Event|Treatment (Ethanol)|"Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.~ethanol: 70% ethanol catheter lock therapy"
225416|NCT01472939|B5|Baseline|Total|Total of all reporting groups
225417|NCT01472939|B4|Baseline|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
225418|NCT01472939|B3|Baseline|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
225419|NCT01472939|B2|Baseline|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
225420|NCT01472939|B1|Baseline|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
225421|NCT01472939|P4|Participant Flow|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
225422|NCT01472939|P3|Participant Flow|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
225423|NCT01472939|P2|Participant Flow|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
225424|NCT01472939|P1|Participant Flow|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
225425|NCT01472939|O3|Outcome|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
225426|NCT01472939|O2|Outcome|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
225427|NCT01472939|O1|Outcome|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
225428|NCT01472939|O3|Outcome|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
225429|NCT01472939|O2|Outcome|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
225430|NCT01472939|O1|Outcome|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
225431|NCT01472939|O3|Outcome|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
225432|NCT01472939|O2|Outcome|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
225433|NCT01472939|O1|Outcome|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
225434|NCT01472939|O4|Outcome|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
225435|NCT01472939|O3|Outcome|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
225436|NCT01472939|O2|Outcome|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
225450|NCT01472874|B1|Baseline|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
225451|NCT01472874|P1|Participant Flow|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
225452|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
225453|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
225454|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
225455|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
225456|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
225457|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
225458|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
225459|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
225460|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
225461|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
225462|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
225463|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
225464|NCT01472874|E1|Reported Event|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
225465|NCT01472835|B3|Baseline|Total|Total of all reporting groups
225466|NCT01472835|B2|Baseline|Control|Patient will not receive no sedation during their 1st procedure and sedation during their 2nd procedure
225467|NCT01472835|B1|Baseline|Sedation|"Pt will receive sedation with their 1st procedure and no sedation with their 2nd procedure~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
225468|NCT01472835|P2|Participant Flow|Control|Patient will not receive sedation during their 1st procedure, but receive sedation during the 2nd procedure
225469|NCT01472835|P1|Participant Flow|Sedation|"Pt will receive sedation with their 1st procedure, then a control procedure will be done without sedation~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
225470|NCT01472835|O2|Outcome|Control|Patient will not receive sedation during procedure
225471|NCT01472835|O1|Outcome|Sedation|"Pt will receive sedation with their procedure~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
225472|NCT01472835|O2|Outcome|Control|Patient will not receive sedation during procedure
225473|NCT01472835|O1|Outcome|Sedation|"Pt will receive sedation with their procedure~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
225474|NCT01472835|O2|Outcome|Control|Patient will not receive sedation during the 1st procedure, but receive sedation during their 2nd procedure
225475|NCT01472835|O1|Outcome|Sedation|"Pt will receive sedation with their 1st procedure and no sedation with their 2nd procedure~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
225476|NCT01472835|O2|Outcome|Control|Patient will not receive sedation during procedure
225477|NCT01472835|O1|Outcome|Sedation|"Pt will receive sedation with their procedure~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
225478|NCT01472835|O2|Outcome|Control|Patient will not receive sedation during their 1st procedure but receive sedation during their 2nd procedure
225479|NCT01472835|O1|Outcome|Sedation|"Pt will receive sedation with their 1st procedure and no sedation with their 2nd procedure~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
225480|NCT01472835|E2|Reported Event|Control|Patient did not receive sedation during procedure
225481|NCT01472835|E1|Reported Event|Sedation|"Pt received sedation with their procedure~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
225482|NCT01472822|B3|Baseline|Total|Total of all reporting groups
225483|NCT01472822|B2|Baseline|Placebo|
225484|NCT01472822|B1|Baseline|Omija|
225485|NCT01472822|P2|Participant Flow|Placebo|"Placebo(2times/day, 4tablets/day, 1.2g/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Omija extract.."
225486|NCT01472822|P1|Participant Flow|Omija Extract.|"Omija extract.(2times/day, 4tablets/day, 1.2g/day) for 12weeks~Omija extract.: Omija extracted with ethanol and then concentrated and dried."
225487|NCT01472822|O2|Outcome|Placebo|Oral intake placebo(1.2g/day) for 12weeks
225488|NCT01472822|O1|Outcome|Omija Extract|Oral intake Omija extract(1.2g/day) for 12weeks.
225489|NCT01472822|O2|Outcome|Placebo|Oral intake placebo(1.2g/day) for 12weeks
225490|NCT01472822|O1|Outcome|Omija Extract|Oral intake Omija extract(1.2g/day) for 12weeks.
225491|NCT01472822|O2|Outcome|Placebo|Oral intake placebo(1.2g/day) for 12weeks
225492|NCT01472822|O1|Outcome|Omija Extract|Oral intake Omija extract(1.2g/day) for 12weeks.
225493|NCT01472822|O2|Outcome|Placebo|Oral intake placebo(1.2g/day) for 12weeks
225494|NCT01472822|O1|Outcome|Omija Extract|Oral intake Omija extract(1.2g/day) for 12weeks.
225495|NCT01472822|O2|Outcome|Placebo|Oral intake placebo(1.2g/day) for 12weeks
225496|NCT01472822|O1|Outcome|Omija Extract|Oral intake Omija extract(1.2g/day) for 12weeks.
225497|NCT01472822|E2|Reported Event|Placebo|
225498|NCT01472822|E1|Reported Event|Omija|
225499|NCT01472562|B1|Baseline|All Patients|Study Treatment Arm
225500|NCT01472562|P1|Participant Flow|All Patients|Study Treatment Arm
225501|NCT01472562|O1|Outcome|All Patients|Study Treatment Arm
225502|NCT01472562|O1|Outcome|All Patients|Study Treatment Arm
225503|NCT01472562|E1|Reported Event|All Patients|Study Treatment Arm
225504|NCT01472432|B3|Baseline|Total|Total of all reporting groups
225505|NCT01472432|B2|Baseline|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
225506|NCT01472432|B1|Baseline|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
225507|NCT01472432|P2|Participant Flow|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
225508|NCT01472432|P1|Participant Flow|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
225509|NCT01472432|O2|Outcome|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
225643|NCT01471379|P3|Participant Flow|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
225510|NCT01472432|O1|Outcome|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
225511|NCT01472432|O2|Outcome|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.Plus Metformin and/or Sulfonylurea"
225512|NCT01472432|O1|Outcome|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~Placebo: Placebo is added to the standard good medical practice. Plus Metformin and/or Sulfonylurea"
225513|NCT01472432|O2|Outcome|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
225514|NCT01472432|O1|Outcome|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
225515|NCT01472432|O2|Outcome|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
225516|NCT01472432|O1|Outcome|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
225517|NCT01472432|O2|Outcome|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
225518|NCT01472432|O1|Outcome|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
225519|NCT01472432|O2|Outcome|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
225520|NCT01472432|O1|Outcome|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
225521|NCT01472432|E2|Reported Event|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
225522|NCT01472432|E1|Reported Event|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
225523|NCT01472380|B1|Baseline|Efavirenz Alone, FFA Alone, Enfavirenz and FFA Together|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period. On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals. On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg following an overnight fast of at least 10 hours
225524|NCT01472380|P1|Participant Flow|Efavirenz Alone, FFA Alone, Enfavirenz and FFA Together|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period. On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals. On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg following an overnight fast of at least 10 hours
225525|NCT01472380|O2|Outcome|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
225526|NCT01472380|O1|Outcome|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period
225527|NCT01472380|O2|Outcome|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
225528|NCT01472380|O1|Outcome|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period
225529|NCT01472380|O2|Outcome|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
225530|NCT01472380|O1|Outcome|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period
225531|NCT01472380|E3|Reported Event|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
225532|NCT01472380|E2|Reported Event|Fenofibric Acid Alone|On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals.
225533|NCT01472380|E1|Reported Event|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
225534|NCT01472341|B1|Baseline|All Participants|Participants receiving routine care under a diabetologist.
225535|NCT01472341|P1|Participant Flow|All Participants|Participants receiving routine care under a diabetologist.
225536|NCT01472341|O1|Outcome|All Participants|Participants receiving routine care under a diabetologist.
225537|NCT01472341|O1|Outcome|All Participants|Participants receiving routine care under a diabetologist.
225538|NCT01472341|O1|Outcome|All Participants|Participants receiving routine care under a diabetologist.
225539|NCT01472341|E1|Reported Event|All Participants|Participants receiving routine care under a diabetologist.
225540|NCT01472289|B1|Baseline|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic muscle of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
225541|NCT01472289|P1|Participant Flow|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells (BMMNCs) concentrate prepared using the Res-Q 60 technology (a point of care system) and injected the concentrate intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
225542|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
225543|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
225544|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
225545|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
225546|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
226209|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
225547|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
225548|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
225549|NCT01472289|E1|Reported Event|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic muscle of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
225550|NCT01472185|B3|Baseline|Total|Total of all reporting groups
225551|NCT01472185|B2|Baseline|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
225552|NCT01472185|B1|Baseline|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
225553|NCT01472185|P2|Participant Flow|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
225554|NCT01472185|P1|Participant Flow|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
225555|NCT01472185|O2|Outcome|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
225556|NCT01472185|O1|Outcome|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
225557|NCT01472185|O2|Outcome|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
225558|NCT01472185|O1|Outcome|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
225559|NCT01472185|O2|Outcome|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
225560|NCT01472185|O1|Outcome|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
225561|NCT01472185|O2|Outcome|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
225562|NCT01472185|O1|Outcome|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
225563|NCT01472185|O2|Outcome|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
225564|NCT01472185|O1|Outcome|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
225565|NCT01472185|E2|Reported Event|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
225566|NCT01472185|E1|Reported Event|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
225567|NCT01471782|B7|Baseline|Total|Total of all reporting groups
225568|NCT01471782|B6|Baseline|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
225569|NCT01471782|B5|Baseline|Phase 1: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
225570|NCT01471782|B4|Baseline|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
225571|NCT01471782|B3|Baseline|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225572|NCT01471782|B2|Baseline|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225573|NCT01471782|B1|Baseline|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225574|NCT01471782|P6|Participant Flow|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
225575|NCT01471782|P5|Participant Flow|Phase 1: Blinatumomab 5/15 µg/m²/Day|PK Expansion: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
225576|NCT01471782|P4|Participant Flow|Phase 1: Blinatumomab 15/30 µg/m²/Day|Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
225577|NCT01471782|P3|Participant Flow|Phase 1: Blinatumomab 30 µg/m²/Day|Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225578|NCT01471782|P2|Participant Flow|Phase 1: Blinatumomab 15 µg/m²/Day|Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225579|NCT01471782|P1|Participant Flow|Phase 1: Blinatumomab 5 µg/m²/Day|Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225580|NCT01471782|O3|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day.
225581|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day.
225582|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day..
225583|NCT01471782|O6|Outcome|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
225584|NCT01471782|O5|Outcome|Phase 1: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
225585|NCT01471782|O4|Outcome|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
225586|NCT01471782|O3|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225587|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225588|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225589|NCT01471782|O7|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
225590|NCT01471782|O6|Outcome|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
225591|NCT01471782|O5|Outcome|Phase 1: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
225808|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225592|NCT01471782|O4|Outcome|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
225593|NCT01471782|O3|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225594|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225595|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225596|NCT01471782|O3|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
225597|NCT01471782|O2|Outcome|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
225598|NCT01471782|O1|Outcome|Phase 1: Blinatumomab|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate ranging from 5 to 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225599|NCT01471782|O3|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
225600|NCT01471782|O2|Outcome|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
225601|NCT01471782|O1|Outcome|Phase 1: Blinatumomab|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate ranging from 5 to 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225602|NCT01471782|O3|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
225603|NCT01471782|O2|Outcome|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
225604|NCT01471782|O1|Outcome|Phase 1: Blinatumomab|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate ranging from 5 to 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225605|NCT01471782|O3|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day.
225606|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day.
225607|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day.
225608|NCT01471782|O5|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225609|NCT01471782|O4|Outcome|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
225610|NCT01471782|O3|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
225611|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225612|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225613|NCT01471782|O7|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
225644|NCT01471379|P2|Participant Flow|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
226210|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
225614|NCT01471782|O6|Outcome|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
225615|NCT01471782|O5|Outcome|Phase 1: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
225616|NCT01471782|O4|Outcome|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
225617|NCT01471782|O3|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225618|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225619|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225620|NCT01471782|O4|Outcome|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
225621|NCT01471782|O3|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225622|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225623|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225624|NCT01471782|E6|Reported Event|Total|All Participants who received blinatumomab administered as a continuous intravenous infusion at a constant daily flow rate.
225625|NCT01471782|E5|Reported Event|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225626|NCT01471782|E4|Reported Event|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
225627|NCT01471782|E3|Reported Event|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
225628|NCT01471782|E2|Reported Event|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225629|NCT01471782|E1|Reported Event|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
225630|NCT01471691|B3|Baseline|Total|Total of all reporting groups
225631|NCT01471691|B2|Baseline|Intravitreal Ranibizumab 1.0mg|ranibizumab 1.0mg: High dose
225632|NCT01471691|B1|Baseline|Intravitreal Ranibizumab 0.5mg|ranibizumab 0.5mg: Standard dose
225633|NCT01471691|P2|Participant Flow|Intravitreal Ranibizumab 1.0mg|ranibizumab 1.0mg: High dose Patients were given six months of monthly treatment with the 1.0mg ranibizumab dose, followed by six months of evaluation and PRN treatment based upon pre-specified criteria.
225634|NCT01471691|P1|Participant Flow|Intravitreal Ranibizumab 0.5mg|ranibizumab 0.5mg: Standard dose Patients were given six months of monthly treatment with the standard 0.5mg ranibizumab dose, followed by six months of evaluation and PRN treatment based upon pre-specified criteria.
225635|NCT01471691|O2|Outcome|Intravitreal Ranibizumab 1.0mg|ranibizumab 1.0mg: High dose
225636|NCT01471691|O1|Outcome|Intravitreal Ranibizumab 0.5mg|ranibizumab 0.5mg: Standard dose
225637|NCT01471691|E2|Reported Event|Intravitreal Ranibizumab 1.0mg|ranibizumab 1.0mg: High dose
225638|NCT01471691|E1|Reported Event|Intravitreal Ranibizumab 0.5mg|ranibizumab 0.5mg: Standard dose
225639|NCT01471379|B4|Baseline|Total|Total of all reporting groups
225640|NCT01471379|B3|Baseline|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
225641|NCT01471379|B2|Baseline|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
225642|NCT01471379|B1|Baseline|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
261428|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
225645|NCT01471379|P1|Participant Flow|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg twice a day (BID) (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran per orally (PO), BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
225646|NCT01471379|O3|Outcome|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
225647|NCT01471379|O2|Outcome|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
225648|NCT01471379|O1|Outcome|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
225649|NCT01471379|O3|Outcome|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
225650|NCT01471379|O2|Outcome|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
225651|NCT01471379|O1|Outcome|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
225652|NCT01471379|O3|Outcome|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
225653|NCT01471379|O2|Outcome|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
225654|NCT01471379|O1|Outcome|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
225655|NCT01471379|O3|Outcome|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
225656|NCT01471379|O2|Outcome|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
225657|NCT01471379|O1|Outcome|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
225658|NCT01471379|O3|Outcome|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
225659|NCT01471379|O2|Outcome|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
225660|NCT01471379|O1|Outcome|Group A (50mg - 100mg)|"Group A begins treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
225661|NCT01471379|E3|Reported Event|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
225662|NCT01471379|E2|Reported Event|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
225663|NCT01471379|E1|Reported Event|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
225664|NCT01471353|B1|Baseline|Sorafenib Plus Capecitabine (SorCape)|"Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.~Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days"
225665|NCT01471353|P1|Participant Flow|Sorafenib Plus Capecitabine (SorCape)|"Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.~Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days"
225666|NCT01471353|O1|Outcome|Sorafenib Plus Capecitabine (SorCape)|"Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.~Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days"
225667|NCT01471353|O1|Outcome|Sorafenib Plus Capecitabine (SorCape)|"Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.~Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days"
225668|NCT01471353|O1|Outcome|Sorafenib Plus Capecitabine (SorCape)|"Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.~Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days"
225669|NCT01471353|E1|Reported Event|Sorafenib Plus Capecitabine (SorCape)|"Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.~Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days"
225670|NCT01471340|B3|Baseline|Total|Total of all reporting groups
225671|NCT01471340|B2|Baseline|Mometasone Furoate (MF) MDI BID|MF MDI administered as two puffs of 100 mcg or 200 mcg, twice daily, with oral inhalation of a pressurized inhalation aerosol
225672|NCT01471340|B1|Baseline|Mometasone Furoate/Formoterol (MF/F) MDI BID|MF/F MDI administered as two puffs of 100/5 mcg or 200/5 mcg, twice daily, with oral inhalation of a pressurized inhalation aerosol
225673|NCT01471340|P2|Participant Flow|Mometasone Furoate (MF) MDI BID|MF MDI administered as two puffs of 100 mcg or 200 mcg, twice daily (pooled MF treatments), with oral inhalation of a pressurized inhalation aerosol
225674|NCT01471340|P1|Participant Flow|Mometasone Furoate/Formoterol (MF/F) MDI BID|MF/F MDI administered as two puffs of 100/5 mcg or 200/5 mcg, twice daily (pooled MF/F treatments), with oral inhalation of a pressurized inhalation aerosol
225675|NCT01471340|O2|Outcome|MF MDI BID|MF MDI administered as two puffs of 100 mcg or 200 mcg, twice daily (pooled MF treatments), with oral inhalation of a pressurized inhalation aerosol
225676|NCT01471340|O1|Outcome|MF/F MDI BID|MF/F MDI administered as two puffs of 100/5 mcg or 200/5 mcg, twice daily (pooled MF/F treatments), with oral inhalation of a pressurized inhalation aerosol
225677|NCT01471340|O2|Outcome|MF MDI BID|MF MDI administered as two puffs of 100 mcg or 200 mcg, twice daily (pooled MF treatments), with oral inhalation of a pressurized inhalation aerosol
225678|NCT01471340|O1|Outcome|MF/F MDI BID|MF/F MDI administered as two puffs of 100/5 mcg or 200/5 mcg, twice daily (pooled MF/F treatments), with oral inhalation of a pressurized inhalation aerosol
225679|NCT01471340|O2|Outcome|MF MDI BID|MF MDI administered as two puffs of 100 mcg or 200 mcg, twice daily (pooled MF treatments), with oral inhalation of a pressurized inhalation aerosol
225680|NCT01471340|O1|Outcome|MF/F MDI BID|MF/F MDI administered as two puffs of 100/5 mcg or 200/5 mcg, twice daily (pooled MF/F treatments), with oral inhalation of a pressurized inhalation aerosol
225681|NCT01471340|E2|Reported Event|MF MDI BID|
225682|NCT01471340|E1|Reported Event|MF/F MDI BID|
225683|NCT01471639|B1|Baseline|Intranasal Ketorolac (Sprix)|"FDA approved drug used in single arm study~intranasal ketorolac: 15 mg"
225684|NCT01471639|P1|Participant Flow|Intranasal Ketorolac (Sprix)|"FDA approved drug used in single arm study~intranasal ketorolac: 15 mg"
225685|NCT01471639|O1|Outcome|Intranasal Ketorolac (Sprix)|"FDA approved drug used in single arm study~intranasal ketorolac: 15 mg"
225686|NCT01471639|O1|Outcome|Intranasal Ketorolac (Sprix)|"FDA approved drug used in single arm study~intranasal ketorolac: 15 mg"
225687|NCT01471639|E1|Reported Event|Intranasal Ketorolac (Sprix)|"FDA approved drug used in single arm study~intranasal ketorolac: 15 mg"
225688|NCT01471626|B1|Baseline|Telematic Attended Polysomnography|"All patients underwent one Home-PSG, using Dream and Sleepbox (Medatec, Belgium), that is a wireless system able to communicate with Dream, and with Internet through a wi-fi/3G interface. It is equipped with a digital infrared camera, and with a speaker/microphone system for bidirectional audio/video communication via Skype.~The Sleep Lab nurse performed a discontinue monitoring of the PSG. In case of defective signals, she called the patient who had been previously educated to replace the sensors."
225689|NCT01471626|P1|Participant Flow|Telematic Attended Polysomnography|"All patients underwent one Home-PSG, using Dream and Sleepbox (Medatec, Belgium), that is a wireless system able to communicate with Dream, and with Internet through a wi-fi/3G interface. It is equipped with a digital infrared camera, and with a speaker/microphone system for bidirectional audio/video communication via Skype.~The Sleep Lab nurse performed a discontinue monitoring of the PSG. In case of defective signals, she called the patient who had been previously educated to replace the sensors."
225690|NCT01471626|O1|Outcome|Telematic Attended Polysomnography|"All patients underwent one Home-PSG, using Dream and Sleepbox (Medatec, Belgium), that is a wireless system able to communicate with Dream, and with Internet through a wi-fi/3G interface. It is equipped with a digital infrared camera, and with a speaker/microphone system for bidirectional audio/video communication via Skype.~The Sleep Lab nurse performed a discontinue monitoring of the PSG. In case of defective signals, she called the patient who had been previously educated to replace the sensors."
225691|NCT01471626|E1|Reported Event|Telematic Attended Polysomnography|"All patients underwent one Home-PSG, using Dream and Sleepbox (Medatec, Belgium), that is a wireless system able to communicate with Dream, and with Internet through a wi-fi/3G interface. It is equipped with a digital infrared camera, and with a speaker/microphone system for bidirectional audio/video communication via Skype.~The Sleep Lab nurse performed a discontinue monitoring of the PSG. In case of defective signals, she called the patient who had been previously educated to replace the sensors."
225692|NCT01471574|B5|Baseline|Total|Total of all reporting groups
225693|NCT01471574|B4|Baseline|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225694|NCT01471574|B3|Baseline|HAART: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225769|NCT01471015|O2|Outcome|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.~Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
225809|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225695|NCT01471574|B2|Baseline|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225696|NCT01471574|B1|Baseline|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225697|NCT01471574|P4|Participant Flow|Non-­HAART Therapy|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225698|NCT01471574|P3|Participant Flow|HAART: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225699|NCT01471574|P2|Participant Flow|HAART: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225700|NCT01471574|P1|Participant Flow|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225701|NCT01471574|O5|Outcome|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225702|NCT01471574|O4|Outcome|HAART Therapy: Daclatasvir 30 or 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225703|NCT01471574|O3|Outcome|HAART Therapy: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225704|NCT01471574|O2|Outcome|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225705|NCT01471574|O1|Outcome|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225706|NCT01471574|O5|Outcome|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225707|NCT01471574|O4|Outcome|HAART Therapy: Daclatasvir 30, 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225804|NCT01470599|B1|Baseline|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225708|NCT01471574|O3|Outcome|HAART Therapy: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225709|NCT01471574|O2|Outcome|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225710|NCT01471574|O1|Outcome|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225711|NCT01471574|O4|Outcome|HAART Therapy: Daclatasvir 30 or 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225712|NCT01471574|O3|Outcome|HAART Therapy: Daclatasvir, 30mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg),, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225713|NCT01471574|O2|Outcome|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225714|NCT01471574|O1|Outcome|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225715|NCT01471574|O2|Outcome|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225716|NCT01471574|O1|Outcome|HAART Therapy: Daclatasvir 30 or 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225717|NCT01471574|O2|Outcome|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225718|NCT01471574|O1|Outcome|HAART Therapy: Daclatasvir 30 or 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225719|NCT01471574|O5|Outcome|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225720|NCT01471574|O4|Outcome|HAART Therapy: Daclatasvir 30 or 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225805|NCT01470599|P2|Participant Flow|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225721|NCT01471574|O3|Outcome|HAART: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received daclatasvir tablets, 90 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225722|NCT01471574|O2|Outcome|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225723|NCT01471574|O1|Outcome|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225724|NCT01471574|E4|Reported Event|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225725|NCT01471574|E3|Reported Event|HAART: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225726|NCT01471574|E2|Reported Event|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225727|NCT01471574|E1|Reported Event|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
225728|NCT01471197|B3|Baseline|Total|Total of all reporting groups
225729|NCT01471197|B2|Baseline|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 mg/m^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
225730|NCT01471197|B1|Baseline|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
225731|NCT01471197|P2|Participant Flow|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 milligram per meter squared (mg/m^2), Once every 3 weeks during Treatment Phase, 10 minute infusion.
225732|NCT01471197|P1|Participant Flow|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
225733|NCT01471197|O2|Outcome|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 mg/m^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
225734|NCT01471197|O1|Outcome|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
225735|NCT01471197|O2|Outcome|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 mg/m^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
225736|NCT01471197|O1|Outcome|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
225737|NCT01471197|O2|Outcome|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 mg/m^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
225738|NCT01471197|O1|Outcome|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
225739|NCT01471197|E2|Reported Event|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 mg/m^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
225740|NCT01471197|E1|Reported Event|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
225741|NCT01471171|B1|Baseline|Overall Study Safety Population|All patients randomized into the crossover study were included in the safety population
225742|NCT01471171|P2|Participant Flow|Placebo - Aclidinium Bromide 400 μg|The study consisted of 2 treatment periods of 22 (±2) days separated by a washout period of 14 (-2/+7) days. In treatment period 1, patients received 1 puff of placebo via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks. In treatment period 2, patients received 1 puff of aclidinium bromide 400 μg via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
225806|NCT01470599|P1|Participant Flow|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225743|NCT01471171|P1|Participant Flow|Aclidinium Bromide 400 μg - Placebo|The study consisted of 2 treatment periods of 22 (±2) days separated by a washout period of 14 (-2/+7) days. In treatment period 1, patients received 1 puff of aclidinium bromide 400 μg via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks. In treatment period 2, patients received 1 puff of placebo via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
225744|NCT01471171|O2|Outcome|Placebo|Placebo: Oral inhalation by Genuair® multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) for 3 weeks.
225745|NCT01471171|O1|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide: Oral inhalation via Genuair® multidose dry powder inhaler. 1 puff of 400 μg in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
225746|NCT01471171|O2|Outcome|Placebo|Placebo: Oral inhalation by Genuair® multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) for 3 weeks.
225747|NCT01471171|O1|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide: Oral inhalation via Genuair® multidose dry powder inhaler. 1 puff of 400 μg in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
225748|NCT01471171|O2|Outcome|Placebo|Placebo: Oral inhalation by Genuair® multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) for 3 weeks.
225749|NCT01471171|O1|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide: Oral inhalation via Genuair® multidose dry powder inhaler. 1 puff of 400 μg in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
225750|NCT01471171|E2|Reported Event|Placebo|Placebo: Oral inhalation by Genuair® multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) for 3 weeks.
225751|NCT01471171|E1|Reported Event|Aclidinium Bromide 400 μg Bid|Aclidinium bromide: Oral inhalation via Genuair® multidose dry powder inhaler. 1 puff of 400 μg in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
225752|NCT01471041|B1|Baseline|Venous Window Needle Guide|"Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula~Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium"
225753|NCT01471041|P1|Participant Flow|Venous Window Needle Guide|"Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula~Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium"
225754|NCT01471041|O1|Outcome|Venous Window Needle Guide|"Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula~Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium"
225755|NCT01471041|O1|Outcome|Venous Window Needle Guide|"Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula~Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium"
225756|NCT01471041|E1|Reported Event|Venous Window Needle Guide|"Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula~Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium"
225757|NCT01471015|B4|Baseline|Total|Total of all reporting groups
225758|NCT01471015|B3|Baseline|Placebo|"Placebo given x2 doses, with the first given within 12 hours of delivery and the second given at 7 days old~Placebo: Placebo given x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old"
225759|NCT01471015|B2|Baseline|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.~Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
225760|NCT01471015|B1|Baseline|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days~Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
225761|NCT01471015|P3|Participant Flow|Placebo|"Placebo given x2 doses, with the first given within 12 hours of delivery and the second given at 7 days old~Placebo: Placebo given x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old"
225762|NCT01471015|P2|Participant Flow|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.~Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
225763|NCT01471015|P1|Participant Flow|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days~Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
225764|NCT01471015|O2|Outcome|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.~Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
225765|NCT01471015|O1|Outcome|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days~Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
225766|NCT01471015|O2|Outcome|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.~Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
225767|NCT01471015|O1|Outcome|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days~Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
225768|NCT01471015|O3|Outcome|Placebo|"Placebo given x2 doses, with the first given within 12 hours of delivery and the second given at 7 days old~Placebo: Placebo given x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old"
225807|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225770|NCT01471015|O1|Outcome|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days~Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
225771|NCT01471015|E3|Reported Event|Placebo|"Placebo given x2 doses, with the first given within 12 hours of delivery and the second given at 7 days old~Placebo: Placebo given x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old"
225772|NCT01471015|E2|Reported Event|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.~Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
225773|NCT01471015|E1|Reported Event|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days~Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
225774|NCT01470859|B3|Baseline|Total|Total of all reporting groups
225775|NCT01470859|B2|Baseline|Levodopa|"Sinemet CR~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
225776|NCT01470859|B1|Baseline|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
225777|NCT01470859|P2|Participant Flow|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
225778|NCT01470859|P1|Participant Flow|Levodopa|"Sinemet Controlled Release (CR)~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
225779|NCT01470859|O2|Outcome|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
225780|NCT01470859|O1|Outcome|Levodopa|"Sinemet CR~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
225781|NCT01470859|O2|Outcome|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
225782|NCT01470859|O1|Outcome|Levodopa|"Sinemet CR~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
225783|NCT01470859|O2|Outcome|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
225784|NCT01470859|O1|Outcome|Levodopa|"Sinemet CR~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
225785|NCT01470859|O2|Outcome|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
225786|NCT01470859|O1|Outcome|Levodopa|"Sinemet CR~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
225787|NCT01470859|O2|Outcome|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
225788|NCT01470859|O1|Outcome|Levodopa|"Sinemet CR~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
225789|NCT01470859|E2|Reported Event|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
225790|NCT01470859|E1|Reported Event|Levodopa|"Sinemet CR~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
225791|NCT01470651|B3|Baseline|Total|Total of all reporting groups
225792|NCT01470651|B2|Baseline|Sugar Pill|"Inactive pill, matched to look like active medication~Placebo Comparator: Inactive pill, matched to look like active medication"
225793|NCT01470651|B1|Baseline|Armodafinil|"Active medication~Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks"
225794|NCT01470651|P2|Participant Flow|Sugar Pill|"Inactive pill, matched to look like active medication~Placebo Comparator: Inactive pill, matched to look like active medication"
225795|NCT01470651|P1|Participant Flow|Armodafinil|"Active medication~Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks"
225796|NCT01470651|O2|Outcome|Sugar Pill|"Inactive pill, matched to look like active medication~Placebo Comparator: Inactive pill, matched to look like active medication"
225797|NCT01470651|O1|Outcome|Armodafinil|"Active medication~Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks"
225798|NCT01470651|O2|Outcome|Sugar Pill|"Inactive pill, matched to look like active medication~Placebo Comparator: Inactive pill, matched to look like active medication"
225799|NCT01470651|O1|Outcome|Armodafinil|"Active medication~Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks"
225800|NCT01470651|E2|Reported Event|Sugar Pill|"Inactive pill, matched to look like active medication~Placebo Comparator: Inactive pill, matched to look like active medication"
225801|NCT01470651|E1|Reported Event|Armodafinil|"Active medication~Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks"
225802|NCT01470599|B3|Baseline|Total|Total of all reporting groups
225803|NCT01470599|B2|Baseline|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225810|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225811|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225812|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225813|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225814|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225815|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225816|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225817|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225818|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225819|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225820|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225821|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225822|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225823|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225824|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225825|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225826|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225827|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225828|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225829|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225830|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225831|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225832|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225833|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225834|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225835|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225836|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225837|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225838|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225839|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225840|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225841|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225842|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225843|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225844|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225845|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225846|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225847|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225848|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225849|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225850|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225851|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225852|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225853|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225854|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225855|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225856|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225857|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225858|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225859|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225860|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225861|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225862|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225863|NCT01470599|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225864|NCT01470599|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225865|NCT01470599|E2|Reported Event|Tofacitinib 10 mg BID|Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
225866|NCT01470599|E1|Reported Event|Tofacitinib 5 mg BID|Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
225867|NCT01470469|B3|Baseline|Total|Total of all reporting groups
225868|NCT01470469|B2|Baseline|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
225869|NCT01470469|B1|Baseline|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
225870|NCT01470469|P2|Participant Flow|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
225871|NCT01470469|P1|Participant Flow|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
225872|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
225873|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
225874|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
225875|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
225876|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
225877|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
225878|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
225879|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
225880|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
225881|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
225882|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
225883|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
225884|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
225885|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
225886|NCT01470469|E2|Reported Event|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
225887|NCT01470469|E1|Reported Event|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
225888|NCT01470417|B3|Baseline|Total|Total of all reporting groups
225889|NCT01470417|B2|Baseline|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.~Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
225890|NCT01470417|B1|Baseline|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.~Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
225891|NCT01470417|P2|Participant Flow|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.~Chemotherapy and ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
225967|NCT01470118|B1|Baseline|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
225968|NCT01470118|P3|Participant Flow|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
261429|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
225892|NCT01470417|P1|Participant Flow|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.~Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
225893|NCT01470417|O2|Outcome|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.~Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
225894|NCT01470417|O1|Outcome|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.~Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
225895|NCT01470417|O2|Outcome|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.~Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
225896|NCT01470417|O1|Outcome|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.~Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
225897|NCT01470417|O2|Outcome|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.~Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
225898|NCT01470417|O1|Outcome|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.~Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
225899|NCT01470417|O2|Outcome|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.~Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
225900|NCT01470417|O1|Outcome|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.~Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
225901|NCT01470417|E2|Reported Event|Chemotherapy and ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.~Chemotherapy and ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
225969|NCT01470118|P2|Participant Flow|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
261430|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
225902|NCT01470417|E1|Reported Event|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.~Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
225903|NCT01470248|B1|Baseline|Arsenic Trioxide Treatment|"This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.~Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects"
225904|NCT01470248|P1|Participant Flow|Arsenic Trioxide Treatment|"This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.~Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects"
225905|NCT01470248|O1|Outcome|Arsenic Trioxide Treatment|"This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.~Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects"
225906|NCT01470248|O1|Outcome|Arsenic Trioxide Treatment|"This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.~Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects"
225907|NCT01470248|O1|Outcome|Arsenic Trioxide Treatment|"This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.~Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects"
225908|NCT01470248|O1|Outcome|Arsenic Trioxide Treatment|"This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.~Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects"
225909|NCT01470248|E1|Reported Event|Arsenic Trioxide Treatment|"This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.~Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects"
225910|NCT01470196|B1|Baseline|Treatment Arm|"Carfilzomib, dexamethasone, rituximab~Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8~Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8~Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
225911|NCT01470196|P1|Participant Flow|Carfilzomib, Dexamethasone, and Rituximab|"Carfilzomib, dexamethasone, rituximab~Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8~Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8~Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
225912|NCT01470196|O1|Outcome|Treatment Arm|"Carfilzomib, dexamethasone, rituximab~Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8~Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8~Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
225913|NCT01470196|O1|Outcome|Treatment Arm|"Carfilzomib, dexamethasone, rituximab~Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8~Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8~Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
226271|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
225914|NCT01470196|O1|Outcome|Treatment Arm|"Carfilzomib, dexamethasone, rituximab~Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8~Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8~Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
225915|NCT01470196|O1|Outcome|Treatment Arm|"Carfilzomib, dexamethasone, rituximab~Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8~Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8~Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
225916|NCT01470196|O1|Outcome|Treatment Arm|"Carfilzomib, dexamethasone, rituximab~Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8~Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8~Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
225917|NCT01470196|E1|Reported Event|Treatment Arm|"Carfilzomib, dexamethasone, rituximab~Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8~Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8~Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
225918|NCT01470170|B6|Baseline|Total|Total of all reporting groups
225919|NCT01470170|B5|Baseline|Group 5/ Control|Propofol alone
225920|NCT01470170|B4|Baseline|Group 4|alfentanil 5ug/kg two minutes before propofol
225921|NCT01470170|B3|Baseline|Group 3|alfentanil 5ug/kg immediately before propofol
225922|NCT01470170|B2|Baseline|Group 2|alfentanil 2.5ug/kg two minutes before propofol
225923|NCT01470170|B1|Baseline|Group1|alfentanil 2.5ug/kg immediately before propofol
225924|NCT01470170|P5|Participant Flow|Group 5 Control|TCI propofol administration alone
225925|NCT01470170|P4|Participant Flow|Group 4|Alfentanil 5μg/kg two minutes before TCI propofol administration
225926|NCT01470170|P3|Participant Flow|Group 3|Alfentanil 2.5μg/kg two minutes before TCI propofol administration
225927|NCT01470170|P2|Participant Flow|Group2|Alfentanil 5μg/kg immediately before TCI propofol administration
225928|NCT01470170|P1|Participant Flow|Group1|Alfentanil 2.5μg/kg immediately before TCI propofol administration
225929|NCT01470170|O5|Outcome|Group 5 /Control|Propofol alone
225930|NCT01470170|O4|Outcome|Group 4|alfentanil 5ug/kg two minutes before propofol
225931|NCT01470170|O3|Outcome|Group 3|alfentanil 5ug/kg immediately before propofol
225932|NCT01470170|O2|Outcome|Group 2|alfentanil 2.5ug/kg two minutes before propofol
225933|NCT01470170|O1|Outcome|Group1|alfentanil 2.5ug/kg immediately before propofol
225934|NCT01470170|O5|Outcome|Group 5 /Control|Propofol alone
225935|NCT01470170|O4|Outcome|Group 4|alfentanil 5ug/kg two minutes before propofol
225936|NCT01470170|O3|Outcome|Group 3|alfentanil 5ug/kg immediately before propofol
225937|NCT01470170|O2|Outcome|Group 2|alfentanil 2.5ug/kg two minutes before propofol
225938|NCT01470170|O1|Outcome|Group1|alfentanil 2.5ug/kg immediately before propofol
225939|NCT01470170|O5|Outcome|Group 5 /Control|Propofol alone
225940|NCT01470170|O4|Outcome|Group 4|alfentanil 5ug/kg two minutes before propofol
225941|NCT01470170|O3|Outcome|Group 3|alfentanil 5ug/kg immediately before propofol
225942|NCT01470170|O2|Outcome|Group 2|alfentanil 2.5ug/kg two minutes before propofol
225943|NCT01470170|O1|Outcome|Group1|alfentanil 2.5ug/kg immediately before propofol
225944|NCT01470170|O5|Outcome|Group 5 /Control|Propofol alone
225945|NCT01470170|O4|Outcome|Group 4|alfentanil 5ug/kg two minutes before propofol
225946|NCT01470170|O3|Outcome|Group 3|alfentanil 5ug/kg immediately before propofol
225947|NCT01470170|O2|Outcome|Group 2|alfentanil 2.5ug/kg two minutes before propofol
225948|NCT01470170|O1|Outcome|Group1|alfentanil 2.5ug/kg immediately before propofol
225949|NCT01470170|O5|Outcome|Group 5 /Control|Propofol alone
225950|NCT01470170|O4|Outcome|Group 4|alfentanil 5ug/kg two minutes before propofol
225951|NCT01470170|O3|Outcome|Group 3|alfentanil 5ug/kg immediately before propofol
225952|NCT01470170|O2|Outcome|Group 2|alfentanil 2.5ug/kg two minutes before propofol
225953|NCT01470170|O1|Outcome|Group1|alfentanil 2.5ug/kg immediately before propofol
225954|NCT01470170|E5|Reported Event|Group 5 /Control|Propofol alone
225955|NCT01470170|E4|Reported Event|Group 4|alfentanil 5ug/kg two minutes before propofol
225956|NCT01470170|E3|Reported Event|Group 3|alfentanil 5ug/kg immediately before propofol
225957|NCT01470170|E2|Reported Event|Group 2|alfentanil 2.5ug/kg two minutes before propofol
225958|NCT01470170|E1|Reported Event|Group1|alfentanil 2.5ug/kg immediately before propofol
225959|NCT01470144|B1|Baseline|Treatment|All patients who received at least one dose of EFI
225960|NCT01470144|P1|Participant Flow|Treatment|All patients who received at least one dose of EFI
225961|NCT01470144|O1|Outcome|Treatment|All patients who received at least one dose of EFI
225962|NCT01470144|O1|Outcome|Treatment|All patients who received at least one dose of EFI
225963|NCT01470144|E1|Reported Event|Treatment|All patients who received at least one dose of EFI
225964|NCT01470118|B4|Baseline|Total|Total of all reporting groups
225965|NCT01470118|B3|Baseline|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
225966|NCT01470118|B2|Baseline|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
225970|NCT01470118|P1|Participant Flow|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
225971|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
225972|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
225973|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
225974|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
225975|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
225976|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
225977|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
225978|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
225979|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
225980|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
225981|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
225982|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
225983|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
225984|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
225985|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
225986|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
225987|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
225988|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
225989|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
225990|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
225991|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
225992|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
225993|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
225994|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
225995|NCT01470118|E3|Reported Event|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
225996|NCT01470118|E2|Reported Event|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
225997|NCT01470118|E1|Reported Event|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
225998|NCT01470027|B7|Baseline|Total|Total of all reporting groups
225999|NCT01470027|B6|Baseline|Placebo -Healthy Volunteer|"Healthy Volunteer~Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
226000|NCT01470027|B5|Baseline|N-acetylcysteine 3600mg -Healthy Volunteer|"Healthy Volunteer~N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226001|NCT01470027|B4|Baseline|N-acetylcysteine 1800mg - Healthy Volunteer|"Healthy Volunteer~N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226002|NCT01470027|B3|Baseline|Placebo -Parkinson's Patient|"Parkinson's patient~Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
226003|NCT01470027|B2|Baseline|N-acetylcysteine 3600mg -Parkinson's Patient|"Parkinson's patient~N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226004|NCT01470027|B1|Baseline|N-acetylcysteine 1800mg - Parkinson's Patient|"Parkinson's patient~N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226005|NCT01470027|P3|Participant Flow|Placebo|"Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
226006|NCT01470027|P2|Participant Flow|N-acetylcysteine 3600mg|"N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226007|NCT01470027|P1|Participant Flow|N-acetylcysteine 1800mg|"N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226008|NCT01470027|O6|Outcome|Placebo -Healthy Volunteer|"Healthy Volunteer~Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
226009|NCT01470027|O5|Outcome|N-acetylcysteine 3600mg -Healthy Volunteer|"Healthy Volunteer~N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226010|NCT01470027|O4|Outcome|N-acetylcysteine 1800mg - Healthy Volunteer|"Healthy Volunteer~N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226011|NCT01470027|O3|Outcome|Placebo -Parkinson's Patient|"Parkinson's patient~Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
226012|NCT01470027|O2|Outcome|N-acetylcysteine 3600mg -Parkinson's Patient|"Parkinson's patient~N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226013|NCT01470027|O1|Outcome|N-acetylcysteine 1800mg - Parkinson's Patient|"Parkinson's patient~N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226014|NCT01470027|O6|Outcome|Placebo -Healthy Volunteer|"Healthy Volunteer~Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
226015|NCT01470027|O5|Outcome|N-acetylcysteine 3600mg -Healthy Volunteer|"Healthy Volunteer~N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226016|NCT01470027|O4|Outcome|N-acetylcysteine 1800mg - Healthy Volunteer|"Healthy Volunteer~N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226017|NCT01470027|O3|Outcome|Placebo -Parkinson's Patient|"Parkinson's patient~Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
226018|NCT01470027|O2|Outcome|N-acetylcysteine 3600mg -Parkinson's Patient|"Parkinson's patient~N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226019|NCT01470027|O1|Outcome|N-acetylcysteine 1800mg - Parkinson's Patient|"Parkinson's patient~N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226020|NCT01470027|O6|Outcome|Placebo -Healthy Volunteer|"Healthy Volunteer~Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
226021|NCT01470027|O5|Outcome|N-acetylcysteine 3600mg -Healthy Volunteer|"Healthy Volunteer~N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226022|NCT01470027|O4|Outcome|N-acetylcysteine 1800mg - Healthy Volunteer|"Healthy Volunteer~N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226023|NCT01470027|O3|Outcome|Placebo -Parkinson's Patient|"Parkinson's patient~Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
226024|NCT01470027|O2|Outcome|N-acetylcysteine 3600mg -Parkinson's Patient|"Parkinson's patient~N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226025|NCT01470027|O1|Outcome|N-acetylcysteine 1800mg - Parkinson's Patient|"Parkinson's patient~N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226026|NCT01470027|O6|Outcome|Placebo -Healthy Volunteer|"Healthy Volunteer~Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
226027|NCT01470027|O5|Outcome|N-acetylcysteine 3600mg -Healthy Volunteer|"Healthy Volunteer~N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226028|NCT01470027|O4|Outcome|N-acetylcysteine 1800mg - Healthy Volunteer|"Healthy Volunteer~N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226029|NCT01470027|O3|Outcome|Placebo -Parkinson's Patient|"Parkinson's patient~Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
226030|NCT01470027|O2|Outcome|N-acetylcysteine 3600mg -Parkinson's Patient|"Parkinson's patient~N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226031|NCT01470027|O1|Outcome|N-acetylcysteine 1800mg - Parkinson's Patient|"Parkinson's patient~N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226032|NCT01470027|O6|Outcome|Placebo -Healthy Volunteer|"Healthy Volunteer~Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
226033|NCT01470027|O5|Outcome|N-acetylcysteine 3600mg -Healthy Volunteer|"Healthy Volunteer~N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226034|NCT01470027|O4|Outcome|N-acetylcysteine 1800mg - Healthy Volunteer|"Healthy Volunteer~N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226035|NCT01470027|O3|Outcome|Placebo -Parkinson's Patient|"Parkinson's patient~Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
226036|NCT01470027|O2|Outcome|N-acetylcysteine 3600mg -Parkinson's Patient|"Parkinson's patient~N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226037|NCT01470027|O1|Outcome|N-acetylcysteine 1800mg - Parkinson's Patient|"Parkinson's patient~N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226038|NCT01470027|O6|Outcome|Placebo -Healthy Volunteer|"Healthy Volunteer~Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
226039|NCT01470027|O5|Outcome|N-acetylcysteine 3600mg -Healthy Volunteer|"Healthy Volunteer~N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226040|NCT01470027|O4|Outcome|N-acetylcysteine 1800mg - Healthy Volunteer|"Healthy Volunteer~N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226041|NCT01470027|O3|Outcome|Placebo -Parkinson's Patient|"Parkinson's patient~Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
226042|NCT01470027|O2|Outcome|N-acetylcysteine 3600mg -Parkinson's Patient|"Parkinson's patient~N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226043|NCT01470027|O1|Outcome|N-acetylcysteine 1800mg - Parkinson's Patient|"Parkinson's patient~N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226044|NCT01470027|O6|Outcome|Placebo -Healthy Volunteer|"Healthy Volunteer~Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
226045|NCT01470027|O5|Outcome|N-acetylcysteine 3600mg -Healthy Volunteer|"Healthy Volunteer~N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226046|NCT01470027|O4|Outcome|N-acetylcysteine 1800mg - Healthy Volunteer|"Healthy Volunteer~N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226047|NCT01470027|O3|Outcome|Placebo -Parkinson's Patient|"Parkinson's patient~Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
226048|NCT01470027|O2|Outcome|N-acetylcysteine 3600mg -Parkinson's Patient|"Parkinson's patient~N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226049|NCT01470027|O1|Outcome|N-acetylcysteine 1800mg - Parkinson's Patient|"Parkinson's patient~N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226050|NCT01470027|O6|Outcome|Placebo -Healthy Volunteer|"Healthy Volunteer~Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
226051|NCT01470027|O5|Outcome|N-acetylcysteine 3600mg -Healthy Volunteer|"Healthy Volunteer~N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226052|NCT01470027|O4|Outcome|N-acetylcysteine 1800mg - Healthy Volunteer|"Healthy Volunteer~N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226053|NCT01470027|O3|Outcome|Placebo -Parkinson's Patient|"Parkinson's patient~Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
226054|NCT01470027|O2|Outcome|N-acetylcysteine 3600mg -Parkinson's Patient|"Parkinson's patient~N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226055|NCT01470027|O1|Outcome|N-acetylcysteine 1800mg - Parkinson's Patient|"Parkinson's patient~N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226056|NCT01470027|E6|Reported Event|Placebo -Healthy Volunteer|"Healthy Volunteer~Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
226057|NCT01470027|E5|Reported Event|N-acetylcysteine 3600mg -Healthy Volunteer|"Healthy Volunteer~N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226058|NCT01470027|E4|Reported Event|N-acetylcysteine 1800mg - Healthy Volunteer|"Healthy Volunteer~N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226059|NCT01470027|E3|Reported Event|Placebo -Parkinson's Patient|"Parkinson's patient~Placebo effervescent tablets daily for 30 days~Placebo: effervescent tablets"
226060|NCT01470027|E2|Reported Event|N-acetylcysteine 3600mg -Parkinson's Patient|"Parkinson's patient~N-acetylcysteine 3600mg daily for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226061|NCT01470027|E1|Reported Event|N-acetylcysteine 1800mg - Parkinson's Patient|"Parkinson's patient~N-acetylcysteine 1800mg/day for 30 days~N-acetylcysteine: 900mg NAC effervescent tablets"
226062|NCT01470001|B3|Baseline|Total|Total of all reporting groups
226063|NCT01470001|B2|Baseline|Placebo|"patients is this arm will receive placebo~solifenacin: patient will receive solifenacin 5mg daily or placebo daily"
226064|NCT01470001|B1|Baseline|Solifenacin|"patients in this arm will receive drug~solifenacin: patient will receive solifenacin 5mg daily or placebo daily"
226065|NCT01470001|P2|Participant Flow|Placebo|study subjects who received placebo daily
226066|NCT01470001|P1|Participant Flow|Treatment|study subjects who received solifenacin 5mg daily
226067|NCT01470001|O2|Outcome|Placebo|"patients is this arm will receive placebo~solifenacin: patient will receive solifenacin 5mg daily or placebo daily"
226068|NCT01470001|O1|Outcome|Solifenacin|"patients in this arm will receive drug~solifenacin: patient will receive solifenacin 5mg daily or placebo daily"
226069|NCT01470001|O2|Outcome|Placebo|"patients is this arm will receive placebo~solifenacin: patient will receive solifenacin 5mg daily or placebo daily"
226070|NCT01470001|O1|Outcome|Solifenacin|"patients in this arm will receive drug~solifenacin: patient will receive solifenacin 5mg daily or placebo daily"
226071|NCT01470001|O2|Outcome|Placebo|"patients is this arm will receive placebo~solifenacin: patient will receive solifenacin 5mg daily or placebo daily"
226072|NCT01470001|O1|Outcome|Solifenacin|"patients in this arm will receive drug~solifenacin: patient will receive solifenacin 5mg daily or placebo daily"
226073|NCT01470001|E2|Reported Event|Placebo|"patients is this arm will receive placebo~solifenacin: patient will receive solifenacin 5mg daily or placebo daily"
226074|NCT01470001|E1|Reported Event|Solifenacin|"patients in this arm will receive drug~solifenacin: patient will receive solifenacin 5mg daily or placebo daily"
226075|NCT01469819|B1|Baseline|All Participants|Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
226076|NCT01469819|P1|Participant Flow|All Participants|Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
226077|NCT01469819|O1|Outcome|SIBO (+)|Twenty-five patients were tested for SIBO before treatment with lubiprostone and 17 (68.0%) were SIBO (+) at baseline.
226078|NCT01469819|O2|Outcome|Non-Responders|Subgroup of patients who had <2 times increase in their weekly bowel movement
226079|NCT01469819|O1|Outcome|Responders|Subgroup of patients who clinically responded to lubiprostone defined as > 2 times increase in their weekly bowel movement compared to baseline.
226080|NCT01469819|O2|Outcome|Non-Responders|Subgroup of patients who had <2 times increase in their weekly bowel movement.
226081|NCT01469819|O1|Outcome|Responders|Subgroup of patients who clinically responded to lubiprostone defined as ≥ 2 times increase in their weekly bowel movement.
226082|NCT01469819|O1|Outcome|All Participants|Due to the nature of this project, which did not include placebo, blinded portion to the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients aster all inclusionary criteria were met.
226083|NCT01469819|O1|Outcome|All Participants|Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
226084|NCT01469819|E1|Reported Event|All Participants|Due to the nature of this project, which did not include placebo, blinded portion to the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
226085|NCT01469767|B1|Baseline|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.~Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
226086|NCT01469767|P1|Participant Flow|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.~Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
226087|NCT01469767|O1|Outcome|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.~Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
226088|NCT01469767|O1|Outcome|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.~Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
226089|NCT01469767|O1|Outcome|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.~Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
226090|NCT01469767|O1|Outcome|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.~Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
261431|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
226091|NCT01469767|O1|Outcome|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.~Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
226092|NCT01469767|E1|Reported Event|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.~Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
226093|NCT01469715|B1|Baseline|GBP-CGM|"All participants will wear one active GBP-CGM and one inactive GBP-CGM~GBP CGM: Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active & one mock device simultaneously during hyperglycemic & hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 & 4: Subjects will return to the research center approximately 24 & 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 & 5."
226094|NCT01469715|P1|Participant Flow|GBP-CGM|"All participants will wear one active GBP-CGM and one inactive GBP-CGM~GBP CGM: Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active & one mock device simultaneously during hyperglycemic & hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 & 4: Subjects will return to the research center approximately 24 & 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 & 5."
226095|NCT01469715|O1|Outcome|GBP-CGM|"All participants will wear one active GBP-CGM and one inactive GBP-CGM~GBP CGM: Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active & one mock device simultaneously during hyperglycemic & hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 & 4: Subjects will return to the research center approximately 24 & 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 & 5."
226096|NCT01469715|E1|Reported Event|GBP-CGM|"All participants will wear one active GBP-CGM and one inactive GBP-CGM~GBP CGM: Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active & one mock device simultaneously during hyperglycemic & hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 & 4: Subjects will return to the research center approximately 24 & 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 & 5."
226097|NCT01469637|B3|Baseline|Total|Total of all reporting groups
226098|NCT01469637|B2|Baseline|Sulfamethoxazole + MMX Mesalazine/Mesalamine First|800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for second intervention.
226099|NCT01469637|B1|Baseline|Sulfamethoxazole + MMX Placebo First|800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for second intervention.
226100|NCT01469637|P2|Participant Flow|Sulfamethoxazole + MMX Mesalazine/Mesalamine First|800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for second intervention.
226101|NCT01469637|P1|Participant Flow|Sulfamethoxazole + MMX Placebo First|800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for second intervention.
226102|NCT01469637|O2|Outcome|Sulfamethoxazole + MMX Mesalazine/Mesalamine|800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4.
226103|NCT01469637|O1|Outcome|Sulfamethoxazole + MMX Placebo|800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4.
226104|NCT01469637|O2|Outcome|Sulfamethoxazole + MMX Mesalazine/Mesalamine|800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4.
226105|NCT01469637|O1|Outcome|Sulfamethoxazole + MMX Placebo|800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4.
226106|NCT01469637|E2|Reported Event|Sulfamethoxazole + MMX Mesalazine/Mesalamine|800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4.
261432|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
226107|NCT01469637|E1|Reported Event|Sulfamethoxazole + MMX Placebo|800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4.
226108|NCT01469546|B1|Baseline|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
226109|NCT01469546|P1|Participant Flow|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
226110|NCT01469546|O1|Outcome|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
226111|NCT01469546|O1|Outcome|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
226112|NCT01469546|O1|Outcome|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
226113|NCT01469546|O1|Outcome|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
226114|NCT01469546|E1|Reported Event|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
226115|NCT01469377|B4|Baseline|Total|Total of all reporting groups
226116|NCT01469377|B3|Baseline|Cariprazine 2-4.5 mg|Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator’s discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
226117|NCT01469377|B2|Baseline|Cariprazine 1-2 mg|Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator’s discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
226118|NCT01469377|B1|Baseline|Placebo|Participants received placebo orally once a day for 8 weeks. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
226119|NCT01469377|P3|Participant Flow|Cariprazine 2-4.5 mg|Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator’s discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
226120|NCT01469377|P2|Participant Flow|Cariprazine 1-2 mg|Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator’s discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
226121|NCT01469377|P1|Participant Flow|Placebo|Participants received placebo orally once a day for 8 weeks. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
226122|NCT01469377|O3|Outcome|Cariprazine 2-4.5 mg|Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator’s discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
226152|NCT01469234|P1|Participant Flow|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
226153|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
226154|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
226123|NCT01469377|O2|Outcome|Cariprazine 1-2 mg|Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator’s discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
226124|NCT01469377|O1|Outcome|Placebo|Participants received placebo orally once a day for 8 weeks. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
226125|NCT01469377|O3|Outcome|Cariprazine 2-4.5 mg|Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator’s discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
226126|NCT01469377|O2|Outcome|Cariprazine 1-2 mg|Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator’s discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
226127|NCT01469377|O1|Outcome|Placebo|Participants received placebo orally once a day for 8 weeks. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
226128|NCT01469377|E3|Reported Event|Cariprazine 2-4.5 mg|Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator’s discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
226129|NCT01469377|E2|Reported Event|Cariprazine 1-2 mg|Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator’s discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
226130|NCT01469377|E1|Reported Event|Placebo|Participants received placebo orally once a day for 8 weeks. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
226131|NCT01469364|B1|Baseline|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
226132|NCT01469364|P1|Participant Flow|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
226133|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
226134|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
226155|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
226272|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
226135|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
226136|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
226137|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
226138|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
226139|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
226140|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
226141|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
226142|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
226143|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
226144|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
226145|NCT01469364|E1|Reported Event|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
226146|NCT01469234|B4|Baseline|Total|Total of all reporting groups
226147|NCT01469234|B3|Baseline|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
226148|NCT01469234|B2|Baseline|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
226149|NCT01469234|B1|Baseline|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
226150|NCT01469234|P3|Participant Flow|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
226151|NCT01469234|P2|Participant Flow|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
226273|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
226156|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
226157|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
226158|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
226159|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
226160|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
226161|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
226162|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
226163|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
226164|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
226165|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
226166|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
226167|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
226168|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
226169|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
226170|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
226171|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
226172|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
226173|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
226174|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
226175|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
226176|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
226177|NCT01469234|E3|Reported Event|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
226178|NCT01469234|E2|Reported Event|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
226179|NCT01469234|E1|Reported Event|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
226180|NCT01469221|B3|Baseline|Total|Total of all reporting groups
226181|NCT01469221|B2|Baseline|Placebo|"Matching placebo (40 mL)~Placebo: 6 weekly multi-instillation of matching placebo in 40mL"
226182|NCT01469221|B1|Baseline|Apaziquone|"Apaziquone (4 mg in 40 mL)~Apaziquone: 6 weekly multi-instillation of Apaziquone 4 mg in 40 mL"
226183|NCT01469221|P3|Participant Flow|Open Label-Apaziquone|Single dose of Apaziquone 4 mg in 40 mL
226184|NCT01469221|P2|Participant Flow|Placebo|6 weekly multi-instillation of matching placebo in 40 mL
226185|NCT01469221|P1|Participant Flow|Apaziquone|6 weekly multi-instillation of Apaziquone 4 mg in 40 mL
226186|NCT01469221|O2|Outcome|Placebo|"Matching placebo (40 mL)~Placebo: 6 weekly multi-instillation of matching placebo in 40mL"
226187|NCT01469221|O1|Outcome|Apaziquone|"Apaziquone (4 mg in 40 mL)~Apaziquone: 6 weekly multi-instillation of Apaziquone 4 mg in 40 mL"
226188|NCT01469221|O2|Outcome|Placebo|"Matching placebo (40 mL)~Placebo: 6 weekly multi-instillation of matching placebo in 40mL"
226189|NCT01469221|O1|Outcome|Apaziquone|"Apaziquone (4 mg in 40 mL)~Apaziquone: 6 weekly multi-instillation of Apaziquone 4 mg in 40 mL"
226190|NCT01469221|E3|Reported Event|Open Label-Apaziquone|Single dose of Apaziquone 4 mg in 40 mL
226191|NCT01469221|E2|Reported Event|Placebo|6 weekly multi-instillation of matching placebo in 40 mL
226192|NCT01469221|E1|Reported Event|Apaziquone|6 weekly multi-instillation of Apaziquone 4 mg in 40 mL
226193|NCT01469182|B3|Baseline|Total|Total of all reporting groups
226194|NCT01469182|B2|Baseline|Placebo|Matching placebo tablet, sublingual, once daily.
226195|NCT01469182|B1|Baseline|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
226196|NCT01469182|P2|Participant Flow|Placebo|Matching placebo tablet, sublingual, once daily.
226197|NCT01469182|P1|Participant Flow|SCH 39641 12 Amb a 1-U|12 Units short ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) extract in an allergy immunotherapy tablet (AIT), sublingual, once daily.
226198|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
226199|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
226200|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
226201|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
226202|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
226203|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
226204|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
226205|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
226206|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
226477|NCT01468675|B2|Baseline|Control|Usual Care
226211|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
226212|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
226213|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
226214|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
226215|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
226216|NCT01469182|E2|Reported Event|Placebo|Matching placebo tablet, sublingual, once daily.
226217|NCT01469182|E1|Reported Event|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
226218|NCT01469065|B6|Baseline|Total|Total of all reporting groups
226219|NCT01469065|B5|Baseline|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
226220|NCT01469065|B4|Baseline|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
226221|NCT01469065|B3|Baseline|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
226222|NCT01469065|B2|Baseline|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
226223|NCT01469065|B1|Baseline|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
226224|NCT01469065|P5|Participant Flow|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
226225|NCT01469065|P4|Participant Flow|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
226226|NCT01469065|P3|Participant Flow|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
226227|NCT01469065|P2|Participant Flow|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
226228|NCT01469065|P1|Participant Flow|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
226229|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
226230|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
226231|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
226232|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
226233|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
226234|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
226235|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
226236|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
226237|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
226238|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
226239|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
226240|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
226241|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
226242|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
226243|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
226244|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
226245|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
226246|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
226247|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
226248|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
226249|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
226250|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
226251|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
226252|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
226253|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
226254|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
226255|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
226256|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
226257|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
226258|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
226259|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
226260|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
226261|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
226262|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
226263|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
226264|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
226265|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
226266|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
226267|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
226268|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
226269|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
226270|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
226274|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
226275|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
226276|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
226277|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
226278|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
226279|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
226280|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
226281|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
226282|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
226283|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
226284|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
226285|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
226286|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
226287|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
226288|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
226289|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
226290|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
226291|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
226292|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
226293|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
226294|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
226295|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
226296|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
226297|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
226298|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
226299|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
226300|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
226301|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
226302|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
226303|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
226304|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
226305|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
226306|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
226307|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
226308|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
226309|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
226310|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
226311|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
226312|NCT01469065|E5|Reported Event|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
226313|NCT01469065|E4|Reported Event|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
226314|NCT01469065|E3|Reported Event|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
226315|NCT01469065|E2|Reported Event|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
226316|NCT01469065|E1|Reported Event|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
226317|NCT01469052|B7|Baseline|Total|Total of all reporting groups
226318|NCT01469052|B6|Baseline|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
226319|NCT01469052|B5|Baseline|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
226320|NCT01469052|B4|Baseline|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226321|NCT01469052|B3|Baseline|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226322|NCT01469052|B2|Baseline|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226323|NCT01469052|B1|Baseline|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226324|NCT01469052|P6|Participant Flow|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
226325|NCT01469052|P5|Participant Flow|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
226326|NCT01469052|P4|Participant Flow|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226327|NCT01469052|P3|Participant Flow|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226328|NCT01469052|P2|Participant Flow|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226329|NCT01469052|P1|Participant Flow|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 milligram (mg) tablet orally once daily (QD) followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally twice daily (BID) in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226330|NCT01469052|O2|Outcome|Fasted State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fasted state in cycles of 4 weeks, up to 8 cycles.
226331|NCT01469052|O1|Outcome|Fed State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fed state in cycles of 4 weeks, up to 8 cycles.
226332|NCT01469052|O2|Outcome|Fasted State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fasted state in cycles of 4 weeks, up to 8 cycles.
226333|NCT01469052|O1|Outcome|Fed State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fed state in cycles of 4 weeks, up to 8 cycles.
226334|NCT01469052|O2|Outcome|Fasted State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fasted state in cycles of 4 weeks, up to 8 cycles.
226335|NCT01469052|O1|Outcome|Fed State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fed state in cycles of 4 weeks, up to 8 cycles.
226336|NCT01469052|O2|Outcome|Fasted State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fasted state in cycles of 4 weeks, up to 8 cycles.
226337|NCT01469052|O1|Outcome|Fed State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fed state in cycles of 4 weeks, up to 8 cycles.
226338|NCT01469052|O2|Outcome|Fasted State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fasted state in cycles of 4 weeks, up to 8 cycles.
226339|NCT01469052|O1|Outcome|Fed State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fed state in cycles of 4 weeks, up to 8 cycles.
226340|NCT01469052|O6|Outcome|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
226341|NCT01469052|O5|Outcome|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
226342|NCT01469052|O4|Outcome|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226343|NCT01469052|O3|Outcome|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226344|NCT01469052|O2|Outcome|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226345|NCT01469052|O1|Outcome|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226346|NCT01469052|O6|Outcome|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
226347|NCT01469052|O5|Outcome|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
226348|NCT01469052|O4|Outcome|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226349|NCT01469052|O3|Outcome|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226350|NCT01469052|O2|Outcome|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226351|NCT01469052|O1|Outcome|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226352|NCT01469052|O6|Outcome|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
226353|NCT01469052|O5|Outcome|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
226354|NCT01469052|O4|Outcome|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226355|NCT01469052|O3|Outcome|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226356|NCT01469052|O2|Outcome|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226357|NCT01469052|O1|Outcome|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226358|NCT01469052|O6|Outcome|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
226359|NCT01469052|O5|Outcome|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
226360|NCT01469052|O4|Outcome|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226361|NCT01469052|O3|Outcome|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
261433|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
226362|NCT01469052|O2|Outcome|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226363|NCT01469052|O1|Outcome|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226364|NCT01469052|O6|Outcome|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
226365|NCT01469052|O5|Outcome|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
226366|NCT01469052|O4|Outcome|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226367|NCT01469052|O3|Outcome|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226368|NCT01469052|O2|Outcome|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226369|NCT01469052|O1|Outcome|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
226370|NCT01469052|O1|Outcome|All Treated Participants|All participants of Cohorts 1 to 6 received oral doses of axitinib (AG-013736) (10 mg and 15 mg, QD; 2 mg, 5 mg, 10 mg, 20 mg and 30 mg, BID) tablet in fed or fasted state in cycles of 4 weeks, up to 8 cycles.
226371|NCT01469052|E1|Reported Event|All Treated Participants|All participants of Cohorts 1 to 6 received oral doses of axitinib (AG-013736) (10 mg and 15 mg, QD; 2 mg, 5 mg, 10 mg, 20 mg and 30 mg, BID) tablet in fed or fasted state in cycles of 4 weeks, up to 8 cycles.
226372|NCT01469039|B4|Baseline|Total|Total of all reporting groups
226373|NCT01469039|B3|Baseline|Placebo|Intramuscular injection, given monthly
226374|NCT01469039|B2|Baseline|Aripiprazole Lauroxil 882 mg|Intramuscular injection, given monthly
226375|NCT01469039|B1|Baseline|Aripiprazole Lauroxil 441 mg|Intramuscular injection, given monthly
226376|NCT01469039|P3|Participant Flow|Placebo|Intramuscular injection, given monthly
226377|NCT01469039|P2|Participant Flow|Aripiprazole Lauroxil 882 mg|Intramuscular injection, given monthly
226378|NCT01469039|P1|Participant Flow|Aripiprazole Lauroxil 441 mg|Intramuscular injection, given monthly
226379|NCT01469039|O3|Outcome|Placebo|Intramuscular injection, given monthly
226380|NCT01469039|O2|Outcome|Aripiprazole Lauroxil 882 mg|Intramuscular injection, given monthly
226381|NCT01469039|O1|Outcome|Aripiprazole Lauroxil 441 mg|Intramuscular injection, given monthly
226382|NCT01469039|O3|Outcome|Placebo|Intramuscular injection, given monthly
226383|NCT01469039|O2|Outcome|Aripiprazole Lauroxil 882 mg|Intramuscular injection, given monthly
226384|NCT01469039|O1|Outcome|Aripiprazole Lauroxil 441 mg|Intramuscular injection, given monthly
226385|NCT01469039|E3|Reported Event|Placebo|Intramuscular injection, given monthly
226386|NCT01469039|E2|Reported Event|Aripiprazole Lauroxil 882 mg|Intramuscular injection, given monthly
226387|NCT01469039|E1|Reported Event|Aripiprazole Lauroxil 441 mg|Intramuscular injection, given monthly
226388|NCT01469000|B3|Baseline|Total|Total of all reporting groups
226389|NCT01469000|B2|Baseline|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
226390|NCT01469000|B1|Baseline|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
226391|NCT01469000|P2|Participant Flow|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
226392|NCT01469000|P1|Participant Flow|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
226393|NCT01469000|O2|Outcome|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
226394|NCT01469000|O1|Outcome|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
226395|NCT01469000|O2|Outcome|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
226396|NCT01469000|O1|Outcome|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
226397|NCT01469000|O2|Outcome|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
226398|NCT01469000|O1|Outcome|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
226399|NCT01469000|O2|Outcome|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
226400|NCT01469000|O1|Outcome|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
226401|NCT01469000|O2|Outcome|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
226402|NCT01469000|O1|Outcome|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
226403|NCT01469000|E2|Reported Event|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
226404|NCT01469000|E1|Reported Event|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
226405|NCT01468987|B3|Baseline|Total|Total of all reporting groups
226478|NCT01468675|B1|Baseline|Intervention|Risk Assessment and Prevention Recommendations provided to subjects
226406|NCT01468987|B2|Baseline|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226407|NCT01468987|B1|Baseline|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226408|NCT01468987|P2|Participant Flow|Insulin Glargine + Insulin Lispro|"Includes participants that were randomized to receive Insulin Glargine plus Insulin Lispro.~Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226409|NCT01468987|P1|Participant Flow|LY2605541 + Insulin Lispro|"Includes participants that were randomized to receive LY2605541 plus Insulin Lispro.~Participant-specific dose of LY2605541 was administered subcutaneously (SC) once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial (pre-meal) and supplemental doses for 26 weeks."
226410|NCT01468987|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226411|NCT01468987|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226412|NCT01468987|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226413|NCT01468987|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226414|NCT01468987|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226415|NCT01468987|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226416|NCT01468987|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226417|NCT01468987|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226418|NCT01468987|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine were administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro were administered SC for preprandial and supplemental doses for 26 weeks."
226419|NCT01468987|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226420|NCT01468987|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226421|NCT01468987|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226422|NCT01468987|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226423|NCT01468987|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226424|NCT01468987|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226425|NCT01468987|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226426|NCT01468987|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226427|NCT01468987|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226428|NCT01468987|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226429|NCT01468987|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226430|NCT01468987|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226479|NCT01468675|P2|Participant Flow|Control|Control - Usual Care
226480|NCT01468675|P1|Participant Flow|Intervention|Risk Assessment and Prevention Recommendations
226431|NCT01468987|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226432|NCT01468987|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226433|NCT01468987|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro were administered SC for preprandial and supplemental doses for 26 weeks."
226434|NCT01468987|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226435|NCT01468987|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226436|NCT01468987|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226437|NCT01468987|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226438|NCT01468987|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226439|NCT01468987|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226440|NCT01468987|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine were administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro were administered SC for preprandial and supplemental doses for 26 weeks."
226441|NCT01468987|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226442|NCT01468987|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226443|NCT01468987|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226444|NCT01468987|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226445|NCT01468987|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226446|NCT01468987|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226447|NCT01468987|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226448|NCT01468987|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226449|NCT01468987|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.~Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks."
226450|NCT01468987|E2|Reported Event|Insulin Glargine + Insulin Lispro|"Participant-specific doses of Insulin Glargine were administered SC once daily at bedtime for 26 weeks.~Participant-specific doses of Insulin Lispro were administered SC for preprandial and supplemental doses for 26 weeks."
226451|NCT01468987|E1|Reported Event|LY2605541 + Insulin Lispro|"Participant-specific doses of LY2605541 were administered SC once daily at bedtime for 26 weeks.~Participant-specific doses of Insulin Lispro were administered SC for preprandial and supplemental doses for 26 weeks."
226452|NCT01468896|B3|Baseline|Total|Total of all reporting groups
226453|NCT01468896|B2|Baseline|Arm II (Phase II)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
226454|NCT01468896|B1|Baseline|Arm 1 (Phase 1)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.
226455|NCT01468896|P2|Participant Flow|Arm II (Phase II)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
226456|NCT01468896|P1|Participant Flow|Arm 1 (Phase I)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.
226457|NCT01468896|O2|Outcome|Arm II (Phase II)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
226458|NCT01468896|O1|Outcome|Arm 1 (Phase I)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.
226459|NCT01468896|O2|Outcome|Arm II (Phase II)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
226460|NCT01468896|O1|Outcome|Arm 1 (Phase I)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.
226461|NCT01468896|O2|Outcome|Arm II (Phase II)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
226462|NCT01468896|O1|Outcome|Arm 1 (Phase I)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.
226463|NCT01468896|O1|Outcome|Arm 1 (Phase I)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.
226464|NCT01468896|O2|Outcome|Arm II (Phase II)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
226465|NCT01468896|O1|Outcome|Arm 1 (Phase I)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.
226466|NCT01468896|O1|Outcome|Arm II (Phase II)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
226467|NCT01468896|O2|Outcome|Arm II (Phase II)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
226468|NCT01468896|O1|Outcome|Arm 1 (Phase I)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.
226469|NCT01468896|E2|Reported Event|Arm II (Phase II)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
226470|NCT01468896|E1|Reported Event|Arm 1 (Phase I)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.
226471|NCT01468818|B1|Baseline|Immunotherapy for Metastatic Melanoma|"Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine)."
226472|NCT01468818|P1|Participant Flow|Immunotherapy for Metastatic Melanoma|"Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine)."
226473|NCT01468818|O1|Outcome|Immunotherapy for Metastatic Melanoma|"Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine)."
226474|NCT01468818|O1|Outcome|Immunotherapy for Metastatic Melanoma|"Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine)."
226475|NCT01468818|E1|Reported Event|Immunotherapy for Metastatic Melanoma|"Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine)."
226476|NCT01468675|B3|Baseline|Total|Total of all reporting groups
226482|NCT01468675|O1|Outcome|Intervention|"Validated, web-based risk assessment is being used to assess personalized risk and generate a risk report~risk assessment survey; decision support for providers for prevention based on risk"
226483|NCT01468675|E2|Reported Event|Control|Control subjects completed a risk factors/perceptions assessment and received a 1 page Health Risk Assessment (HRA) AFTER their primary care visit. Coded data was not sent to the EHR.
226484|NCT01468675|E1|Reported Event|Intervention|Intervention subjects completed a risk factors/perceptions assessment and received a 1 page Health Risk Assessment (HRA) prior to a primary care visit. This coded data was sent to the EHR. After their primary care visit, subjects again reported risk perception.
226485|NCT01468584|B1|Baseline|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
226486|NCT01468584|P1|Participant Flow|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
226487|NCT01468584|O1|Outcome|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
226488|NCT01468584|E1|Reported Event|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
226489|NCT01468558|B1|Baseline|Overall Study|All subjects that were enrolled in the study.
226490|NCT01468558|P1|Participant Flow|Overall Study|Subjects first received MAP0004 1.0mg via oral inhalation followed by 48 hours of PK sampling, they then received Ketoconazole (400mg once a day for 4 days) followed by MAP0004 1.0mg and another 48 hours of PK sampling. After a 7-11 day washout, subjects returned to the clinic to receive 1.0mg IV DHE and 48 hours of PK sampling.
226491|NCT01468558|O3|Outcome|IV DHE 1.0mg|IV DHE 1.0mg on Day 1 of Visit 3.
226492|NCT01468558|O2|Outcome|MAP0004 1.0mg + Ketoconazole|Ketoconazole 400mg once a day on Days 3-6 of Visit 2 and MAP0004 1.0mg via inhalation on Day 6 of Visit 2.
226493|NCT01468558|O1|Outcome|MAP0004 1.0mg|MAP0004 1.0mg via inhalation on Day 1 of Visit 2.
226494|NCT01468558|O3|Outcome|IV DHE 1.0mg|IV DHE 1.0mg on Day 1 of Visit 3.
226495|NCT01468558|O2|Outcome|MAP0004 1.0mg + Ketoconazole|Ketoconazole 400mg once a day on Days 3-6 of Visit 2 and MAP0004 1.0mg via inhalation on Day 6 of Visit 2.
226496|NCT01468558|O1|Outcome|MAP0004 1.0mg|MAP0004 1.0mg via inhalation on Day 1 of Visit 2.
226497|NCT01468558|E3|Reported Event|IV DHE 1.0mg|IV DHE 1.0mg on Day 1 of Visit 3.
226498|NCT01468558|E2|Reported Event|MAP0004 1.0mg + Ketoconazole|Ketoconazole 400mg once a day on Days 3-6 of Visit 2 and MAP0004 1.0mg via inhalation on Day 6 of Visit 2.
226499|NCT01468558|E1|Reported Event|MAP0004 1.0mg|MAP0004 1.0mg via inhalation on Day 1 of Visit 2.
226500|NCT01468350|B5|Baseline|Total|Total of all reporting groups
226501|NCT01468350|B4|Baseline|(PART B) Dalfampridine-ER 10mg Then Placebo|"Each subject randomized to the AB arm will receive multiple doses of (A) dalfampridine-ER 10mg and multiple doses of (B) placebo~Day 1, visit 2, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 dose for 1 day. Day 15, visit 4, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day"
226502|NCT01468350|B3|Baseline|(PART B) Placebo Then Dalfampridine-ER 10mg|"Each subject randomized to the BA arm will receive multiple doses of (B) placebo, and multiple doses of (A) dalfampridine-ER 10mg~Day 1, visit 2, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day. Day 15, visit 4, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 tablet for 1 day"
226503|NCT01468350|B2|Baseline|(PART A) Dalfampridine-ER 10mg Then Placebo|"Each subject randomized to the AB arm will receive a single witnessed dose of (A) dalfampridine-ER 10 mg, and a single witnessed dose of (B) placebo, two days apart~Day 1, visit 2, subjects will receive dalfampridine-ER 10mg. Day 3, visit 3 subjects will receive placebo"
226504|NCT01468350|B1|Baseline|(PART A) Placebo Then Dalfampridine-ER 10mg|"Each subject randomized to the BA arm will receive a single witnessed dose of (B) placebo, and a single witnessed dose of (A) dalfampridine-ER 10 mg, two days apart~Day 1, visit 2, subjects will receive placebo. Day 3, visit 3, subjects will receive dalfampridine-ER 10mg"
226505|NCT01468350|P4|Participant Flow|(PART B) Dalfampridine-ER 10mg Then Placebo|"Each subject randomized to the AB arm will receive multiple doses of (A) dalfampridine-ER 10mg and multiple doses of (B) placebo~Day 1, visit 2, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 dose for 1 day. Day 15, visit 4, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day"
226506|NCT01468350|P3|Participant Flow|(PART B) Placebo Then Dalfampridine-ER 10mg|"Each subject randomized to the BA arm will receive multiple doses of (B) placebo, and multiple doses of (A) dalfampridine-ER 10mg~Day 1, visit 2, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day. Day 15, visit 4, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 tablet for 1 day"
226507|NCT01468350|P2|Participant Flow|(PART A) Dalfampridine-ER 10mg Then Placebo|"Each subject randomized to the AB arm will receive a single witnessed dose of (A) dalfampridine-ER 10 mg, and a single witnessed dose of (B) placebo, two days apart~Day 1, visit 2, subjects will receive dalfampridine-ER 10mg. Day 3, visit 3 subjects will receive placebo"
226508|NCT01468350|P1|Participant Flow|(PART A) Placebo Then Dalfampridine-ER 10mg|"Each subject randomized to the BA arm will receive a single witnessed dose of (B) placebo, and a single witnessed dose of (A) dalfampridine-ER 10 mg, two days apart~Day 1, visit 2, subjects will receive placebo. Day 3, visit 3, subjects will receive dalfampridine-ER 10mg"
226509|NCT01468350|O4|Outcome|PART B: Dalfampridine-ER 10mg|"12 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 12 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~Subjects received multiple doses of placebo and multiple doses of dalfampridine-ER 10mg"
226510|NCT01468350|O3|Outcome|PART B: Placebo|"12 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 12 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~Subjects received multiple doses of placebo and multiple doses of dalfampridine-ER 10mg"
226557|NCT01468233|O3|Outcome|Placebo - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive placebo every week (ew) for 12 weeks
226511|NCT01468350|O2|Outcome|PART A: Dalfampridine-ER 10mg|"6 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 5 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~A single witnessed dose of placebo and a single witnessed dose of dalfampridine-ER 10 mg, two days apart"
226512|NCT01468350|O1|Outcome|PART A: Placebo|"6 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 5 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~A single witnessed dose of placebo and a single witnessed dose of dalfampridine-ER 10 mg, two days apart"
226513|NCT01468350|E4|Reported Event|PART B: Dalfampridine-ER 10mg|"12 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 12 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~Subjects received multiple doses of placebo and multiple doses of dalfampridine-ER 10mg"
226514|NCT01468350|E3|Reported Event|PART B: Placebo|"12 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 12 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~Subjects received multiple doses of placebo and multiple doses of dalfampridine-ER 10mg"
226515|NCT01468350|E2|Reported Event|PART A: Dalfampridine-ER 10mg|"6 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 5 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~A single witnessed dose of placebo and a single witnessed dose of dalfampridine-ER 10 mg, two days apart"
226516|NCT01468350|E1|Reported Event|PART A: Placebo|"6 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 5 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~A single witnessed dose of placebo and a single witnessed dose of dalfampridine-ER 10 mg, two days apart"
226517|NCT01468337|B1|Baseline|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
226518|NCT01468337|P1|Participant Flow|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
226519|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
226520|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
226521|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
226522|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
226523|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
226524|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
226525|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
226526|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
226527|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
226528|NCT01468337|E1|Reported Event|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
226529|NCT01468311|B1|Baseline|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)~Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab~BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab~111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.~90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
226530|NCT01468311|P1|Participant Flow|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)~Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab~BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab~111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.~90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
226531|NCT01468311|O1|Outcome|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)~Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab~BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab~111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.~90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
226532|NCT01468311|O1|Outcome|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)~Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab~BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab~111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.~90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
226555|NCT01468233|O5|Outcome|Adalimumab Every Week (EW) - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
226556|NCT01468233|O4|Outcome|Placebo - Baseline Hurley Stage III|Participants with baseline Hurley Stage III randomized to receive placebo every week (ew) for 12 weeks.
226734|NCT01467934|B4|Baseline|Total|Total of all reporting groups
226533|NCT01468311|O1|Outcome|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)~Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab~BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab~111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.~90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
226534|NCT01468311|O1|Outcome|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)~Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab~BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab~111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.~90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
226535|NCT01468311|O1|Outcome|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)~Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab~BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab~111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.~90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
226536|NCT01468311|O1|Outcome|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)~Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab~BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab~111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.~90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
226537|NCT01468311|O1|Outcome|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)~Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab~BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab~111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.~90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
226538|NCT01468311|E1|Reported Event|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)~Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab~BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab~111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.~90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
226539|NCT01468233|B3|Baseline|Total|Total of all reporting groups
226540|NCT01468233|B2|Baseline|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
226541|NCT01468233|B1|Baseline|Placebo|Placebo for 12 weeks
226542|NCT01468233|P6|Participant Flow|Adalimumab Every Week (EW)/Adalimumab Every Week (EW)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
226543|NCT01468233|P5|Participant Flow|Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).
226544|NCT01468233|P4|Participant Flow|Adalimumab Every Week (EW)/Placebo|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
226545|NCT01468233|P3|Participant Flow|Placebo/Placebo|Participants randomized to receive placebo in Period 1 received placebo every week from Week 12 to Week 35 in Period 2 (up to 24 weeks).
226546|NCT01468233|P2|Participant Flow|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
226547|NCT01468233|P1|Participant Flow|Placebo|Placebo for 12 weeks
226548|NCT01468233|O2|Outcome|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
226549|NCT01468233|O1|Outcome|Placebo|Placebo for 12 weeks
226550|NCT01468233|O2|Outcome|Adalimumab Every Week (EW) - Baseline NRS at Worst ≥ 3|Participants with baseline Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) ≥ 3 randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
226551|NCT01468233|O1|Outcome|Placebo - Baseline NRS at Worst ≥ 3|Participants with baseline Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) ≥ 3 randomized to receive placebo every week (ew) for 12 weeks.
226552|NCT01468233|O2|Outcome|Every Week (EW) - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
226553|NCT01468233|O1|Outcome|Placebo - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive placebo every week (ew) for 12 weeks
226554|NCT01468233|O6|Outcome|Adalimumab Every Week (EW) - Baseline Hurley Stage III|Participants with baseline Hurley Stage III randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
226558|NCT01468233|O2|Outcome|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
226559|NCT01468233|O1|Outcome|Placebo|Placebo for 12 weeks
226560|NCT01468233|E6|Reported Event|Adalimumab EW/Adalimumab EW (Period 2)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
226561|NCT01468233|E5|Reported Event|Adalimumab EW/Adalimumab EOW (Period 2)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).
226562|NCT01468233|E4|Reported Event|Adalimumab EW/Placebo (Period 2)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
226563|NCT01468233|E3|Reported Event|Placebo/Placebo (Period 2)|Participants randomized to receive placebo in Period 1 received placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
226564|NCT01468233|E2|Reported Event|Adalimumab EW (Period 1)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
226565|NCT01468233|E1|Reported Event|Placebo (Period 1)|Placebo for 12 weeks.
226566|NCT01468207|B3|Baseline|Total|Total of all reporting groups
226567|NCT01468207|B2|Baseline|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
226568|NCT01468207|B1|Baseline|Placebo|Placebo for 12 weeks.
226569|NCT01468207|P6|Participant Flow|Adalimumab Every Week (EW)/Adalimumab Every Week (EW)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
226570|NCT01468207|P5|Participant Flow|Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive adalimumab 40 mg eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).
226571|NCT01468207|P4|Participant Flow|Adalimumab Every Week (EW)/Placebo|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
226572|NCT01468207|P3|Participant Flow|Placebo/Adalimumab Every Week (EW)|Participants randomized to receive placebo in Period 1 received adalimumab 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to Week 35 in Period 2 (up to 24 weeks).
226573|NCT01468207|P2|Participant Flow|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
226574|NCT01468207|P1|Participant Flow|Placebo|Placebo for 12 weeks.
226575|NCT01468207|O2|Outcome|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
226576|NCT01468207|O1|Outcome|Placebo|Placebo for 12 weeks.
226577|NCT01468207|O2|Outcome|Adalimumab Every Week (EW) - Baseline NRS at Worst ≥ 3|Participants with baseline NRS ≥ 3 randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
226578|NCT01468207|O1|Outcome|Placebo - Baseline NRS at Worst ≥ 3|Participants with baseline NRS ≥ 3 randomized to receive placebo every week (ew) for 12 weeks.
226579|NCT01468207|O2|Outcome|Adalimumab Every Week (EW) - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
226580|NCT01468207|O1|Outcome|Placebo - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive placebo every week (ew) for 12 weeks.
226581|NCT01468207|O6|Outcome|Adalimumab Every Week (ew) - Baseline Hurley Stage III|Participants with baseline Hurley Stage III randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
226582|NCT01468207|O5|Outcome|Adalimumab Every Week (EW) - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
226583|NCT01468207|O4|Outcome|Placebo - Baseline Hurley Stage III|Participants with baseline Hurley Stage III randomized to receive placebo every week (ew) for 12 weeks.
226584|NCT01468207|O3|Outcome|Placebo - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive placebo every week (ew) for 12 weeks.
226585|NCT01468207|O2|Outcome|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
226586|NCT01468207|O1|Outcome|Placebo|Placebo for 12 weeks.
226587|NCT01468207|E6|Reported Event|Adalimumab EW/Adalimumab EW (Period 2)|Participants randomized to receive adalimumab every week (ew) in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
226588|NCT01468207|E5|Reported Event|Adalimumab EW/Adalimumab EOW (Period 2)|Participants randomized to receive adalimumab every week (ew) in Period 1 were re-randomized to receive adalimumab 40 mg every other week (eow) from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).
226589|NCT01468207|E4|Reported Event|Adalimumab EW/Placebo (Period 2)|Participants randomized to receive adalimumab every week (ew) in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
226590|NCT01468207|E3|Reported Event|Placebo/Adalimumab EW (Period 2)|Participants randomized to receive placebo in Period 1 were re-randomized to receive adalimumab 160 mg at Week 12, 80 mg at Week 14, and 40 mg every week (ew) from Week 16 to Week 35 in Period 2 (up to 24 weeks).
226591|NCT01468207|E2|Reported Event|Adalimumab EW (Period 1)|Adalimumab every week (ew) for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
226592|NCT01468207|E1|Reported Event|Placebo (Period 1)|Placebo for 12 weeks
226593|NCT01468181|B6|Baseline|Total|Total of all reporting groups
226594|NCT01468181|B5|Baseline|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
226735|NCT01467934|B3|Baseline|13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone|13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
226595|NCT01468181|B4|Baseline|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
226596|NCT01468181|B3|Baseline|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
226597|NCT01468181|B2|Baseline|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
226598|NCT01468181|B1|Baseline|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
226599|NCT01468181|P5|Participant Flow|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
226600|NCT01468181|P4|Participant Flow|LY2189265 + Thiazolidin Edione (TZD)|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
226601|NCT01468181|P3|Participant Flow|LY2189265 + Alpha-glucosidas e Inhibitor (a-GI)|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
226602|NCT01468181|P2|Participant Flow|LY2189265 + Biguanides (BG)|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
226603|NCT01468181|P1|Participant Flow|LY2189265 + Sulfonylureas (SU)|"LY2189265: 0.75 milligrams (mg) administered subcutaneously (SC), once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
226604|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
226605|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
226606|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
226607|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
226608|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
226609|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
226610|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
226611|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
226612|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
226613|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
226614|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
226615|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
226616|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
226617|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
226618|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
226619|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
226620|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
226621|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
226622|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
226623|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
226624|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
226625|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
226626|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
226627|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
226628|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
226629|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
226630|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
226631|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
226632|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
226633|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
226634|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
226635|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
226636|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
226637|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
226638|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
226639|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
226640|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
226641|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
226642|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
226643|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
226644|NCT01468181|E5|Reported Event|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
226645|NCT01468181|E4|Reported Event|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
226646|NCT01468181|E3|Reported Event|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
226647|NCT01468181|E2|Reported Event|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
226648|NCT01468181|E1|Reported Event|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
226649|NCT01468077|B3|Baseline|Total|Total of all reporting groups
226650|NCT01468077|B2|Baseline|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
226651|NCT01468077|B1|Baseline|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
226652|NCT01468077|P2|Participant Flow|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
226653|NCT01468077|P1|Participant Flow|Tocilizumab, Normal Administration|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (IV) over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
226654|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
261434|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
226655|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
226656|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
226657|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
226658|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
226659|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
226660|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
226661|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
226662|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
226663|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
226664|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
226665|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
226666|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
226667|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
226668|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
226669|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
226670|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
226671|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
226672|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
226673|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
226674|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
226675|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
226676|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
226677|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
226678|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
226679|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
226680|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
226681|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
226682|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
227355|NCT01466387|B6|Baseline|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
226683|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
226684|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
226685|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
226686|NCT01468077|E2|Reported Event|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
226687|NCT01468077|E1|Reported Event|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
226688|NCT01468012|B4|Baseline|Total|Total of all reporting groups
226689|NCT01468012|B3|Baseline|Non-randomized|
226690|NCT01468012|B2|Baseline|Placebo|"placebo~Placebo: matched placebo for LCE condition dosed twice daily"
226691|NCT01468012|B1|Baseline|Levodopa Carbidopa and Entacapone (LCE)|"400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)~levodopa carbidopa and entacapone (LCE): 400mg/100mg/200mg, twice daily"
226692|NCT01468012|P3|Participant Flow|Non-randomized|
226693|NCT01468012|P2|Participant Flow|Placebo|"placebo~Placebo: matched placebo for LCE condition dosed twice daily"
226694|NCT01468012|P1|Participant Flow|Levodopa Carbidopa and Entacapone (LCE)|"400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)~levodopa carbidopa and entacapone (LCE): 400mg/100mg/200mg, twice daily"
226695|NCT01468012|O3|Outcome|Non-randomized|Participants who dropped from the study prior to randomization
226696|NCT01468012|O2|Outcome|Placebo|"placebo~Placebo: matched placebo for LCE condition dosed twice daily"
226697|NCT01468012|O1|Outcome|Levodopa Carbidopa and Entacapone (LCE)|"400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)~levodopa carbidopa and entacapone (LCE): 400mg/100mg/200mg, twice daily"
226698|NCT01468012|O3|Outcome|Non-randomized|
226699|NCT01468012|O2|Outcome|Placebo|"placebo~Placebo: matched placebo for LCE condition dosed twice daily"
226700|NCT01468012|O1|Outcome|Levodopa Carbidopa and Entacapone (LCE)|"400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)~levodopa carbidopa and entacapone (LCE): 400mg/100mg/200mg, twice daily"
226701|NCT01468012|E3|Reported Event|Non-randomized|Participants who dropped from the study prior to randomization
226702|NCT01468012|E2|Reported Event|Placebo|"placebo~Placebo: matched placebo for LCE condition dosed twice daily"
226703|NCT01468012|E1|Reported Event|Levodopa Carbidopa and Entacapone (LCE)|"400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)~levodopa carbidopa and entacapone (LCE): 400mg/100mg/200mg, twice daily"
226704|NCT01467960|B7|Baseline|Total|Total of all reporting groups
226705|NCT01467960|B6|Baseline|Group C|Patients at stage > than II, H&Y
226706|NCT01467960|B5|Baseline|Group B|Patients at Stage II, H&Y
226707|NCT01467960|B4|Baseline|Group A|Patients at Stage I, H&Y
226708|NCT01467960|B3|Baseline|Group III|Healthy Subjects aged more than 65
226709|NCT01467960|B2|Baseline|Group II|Healthy Subjects aged 40-65
226710|NCT01467960|B1|Baseline|Group I|Healthy Subjects aged 20-40
226711|NCT01467960|P6|Participant Flow|Group C|30 Patients at Stage more than III, H&Y classification
226712|NCT01467960|P5|Participant Flow|Group B|30 Patients at Stage II, H&Y classification
226713|NCT01467960|P4|Participant Flow|Group A|30 Patients at Stage I, H&Y classification
226714|NCT01467960|P3|Participant Flow|Group III|30 Healthy Subjects aged more than 65
226715|NCT01467960|P2|Participant Flow|Group II|30 Healthy Subjects aged 40-65
226716|NCT01467960|P1|Participant Flow|Group I|30 Healthy Subjects aged 20-40
226717|NCT01467960|O6|Outcome|Group C|Patients at stage > than II, H&Y
226718|NCT01467960|O5|Outcome|Group B|Patients at Stage II, H&Y
226719|NCT01467960|O4|Outcome|Group A|Patients at Stage I, H&Y
226720|NCT01467960|O3|Outcome|Group III|Healthy Subjects aged more than 65
226721|NCT01467960|O2|Outcome|Group II|Healthy Subjects aged 40-65
226722|NCT01467960|O1|Outcome|Group I|Healthy Subjects aged 20-40
226723|NCT01467960|E6|Reported Event|Group C|Patients at stage > than II, H&Y
226724|NCT01467960|E5|Reported Event|Group B|Patients at Stage II, H&Y
226725|NCT01467960|E4|Reported Event|Group A|Patients at Stage I, H&Y
226726|NCT01467960|E3|Reported Event|Group III|Healthy Subjects aged more than 65
226727|NCT01467960|E2|Reported Event|Group II|Healthy Subjects aged 40-65
226728|NCT01467960|E1|Reported Event|Group I|Healthy Subjects aged 20-40
226729|NCT01467947|B1|Baseline|C1 Esterase Inhibitor|Subjects received 20 IU/kg C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
226730|NCT01467947|P1|Participant Flow|C1 Esterase Inhibitor|Subjects received 20 IU C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
226731|NCT01467947|O1|Outcome|C1 Esterase Inhibitor|Subjects received 20 IU C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
226732|NCT01467947|O1|Outcome|C1 Esterase Inhibitor|Subjects received 20 IU C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
226733|NCT01467947|E1|Reported Event|C1 Esterase Inhibitor|Subjects received 20 IU C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
226736|NCT01467934|B2|Baseline|TIV and PCV13 Together|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
226737|NCT01467934|B1|Baseline|Trivalent Inactivated Influenza Vaccine (TIV) Alone|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1
226738|NCT01467934|P3|Participant Flow|13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone|13-valent pneumococcal conjugate vaccine (PCV13) 0.5ml IM x 1
226739|NCT01467934|P2|Participant Flow|TIV and PCV13 Together|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
226740|NCT01467934|P1|Participant Flow|Trivalent Inactivated Influenza Vaccine (TIV) Alone|Trivalent inactivated influenza vaccine 0.25ml IM X 1
226741|NCT01467934|O3|Outcome|13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone|13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
226742|NCT01467934|O2|Outcome|TIV and PCV13 Together|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
226743|NCT01467934|O1|Outcome|Trivalent Inactivated Influenza Vaccine (TIV) Alone|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1
226744|NCT01467934|E3|Reported Event|13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone|13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
226745|NCT01467934|E2|Reported Event|TIV and PCV13 Together|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
226746|NCT01467934|E1|Reported Event|Trivalent Inactivated Influenza Vaccine (TIV) Alone|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1
226747|NCT01467882|B1|Baseline|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
226748|NCT01467882|P1|Participant Flow|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
226749|NCT01467882|O1|Outcome|Boys|All boys enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
226750|NCT01467882|O1|Outcome|Girls|All girls enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
226751|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
226752|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
226753|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
226754|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
226755|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
226756|NCT01467882|O1|Outcome|AOC Subset|All children in AOC subset who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
226757|NCT01467882|O3|Outcome|Boys|All boys enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
226758|NCT01467882|O2|Outcome|Girls|All girls enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
226759|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
226760|NCT01467882|O1|Outcome|Boys|All boys enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
226761|NCT01467882|O1|Outcome|Girls|All girls enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
226762|NCT01467882|O2|Outcome|All Children Follicle Stimulating Hormone|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
226763|NCT01467882|O1|Outcome|All Children Luteinizing Hormone|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
226764|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
226765|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
226766|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
226767|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
226768|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
226769|NCT01467882|E1|Reported Event|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
226770|NCT01467713|B5|Baseline|Total|Total of all reporting groups
226771|NCT01467713|B4|Baseline|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226772|NCT01467713|B3|Baseline|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226773|NCT01467713|B2|Baseline|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226774|NCT01467713|B1|Baseline|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
226775|NCT01467713|P4|Participant Flow|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226776|NCT01467713|P3|Participant Flow|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226777|NCT01467713|P2|Participant Flow|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226778|NCT01467713|P1|Participant Flow|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
226779|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226780|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226781|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
229015|NCT01461369|O1|Outcome|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
226782|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
226783|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226784|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226785|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226786|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
226787|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226788|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226789|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226790|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
226791|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226792|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226793|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226794|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
226795|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226796|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226797|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226798|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
226799|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226800|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226801|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226802|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
226803|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226804|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226805|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226806|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
226807|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226808|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226809|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226810|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
226811|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226812|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226813|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226814|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
226815|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226816|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226817|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226818|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
226819|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226820|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226821|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226822|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
226823|NCT01467713|E4|Reported Event|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226824|NCT01467713|E3|Reported Event|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
226825|NCT01467713|E2|Reported Event|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
229016|NCT01461369|O3|Outcome|Placebo|Placebo: Capsule
226826|NCT01467713|E1|Reported Event|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
226827|NCT01467700|B5|Baseline|Total|Total of all reporting groups
226828|NCT01467700|B4|Baseline|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
226829|NCT01467700|B3|Baseline|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks.
226830|NCT01467700|B2|Baseline|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
226831|NCT01467700|B1|Baseline|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
226832|NCT01467700|P4|Participant Flow|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
226833|NCT01467700|P3|Participant Flow|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks.
226834|NCT01467700|P2|Participant Flow|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
226835|NCT01467700|P1|Participant Flow|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
226836|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
226837|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
226838|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
226839|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
226840|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
226841|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
226842|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
226843|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
226844|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
226845|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
226846|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
226847|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
226848|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
226849|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
226850|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
226851|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
226852|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
226853|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
226854|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
226855|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
226856|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
226857|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
226858|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
226859|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
226860|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
226861|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
226862|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
226863|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
226864|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
226865|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
226866|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
226867|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
226868|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
226869|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
226870|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
227356|NCT01466387|B5|Baseline|Rabies|Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine.
226871|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
226872|NCT01467700|E4|Reported Event|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
226873|NCT01467700|E3|Reported Event|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks.
226874|NCT01467700|E2|Reported Event|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
226875|NCT01467700|E1|Reported Event|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
226876|NCT01467661|B1|Baseline|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 milligram (mg) per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
226877|NCT01467661|P1|Participant Flow|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 milligram (mg) per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
226878|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
226879|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
226880|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
226881|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
226882|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
226883|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
226884|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
226885|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
226886|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
226887|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
226888|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
226889|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
226890|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 milligram (mg) per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
226891|NCT01467661|E2|Reported Event|SPD422: Post-marketing Trial Safety Analysis Set|Included all subjects in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661).
226892|NCT01467661|E1|Reported Event|SPD422: Safety Analysis Set|Included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).
226893|NCT01467583|B4|Baseline|Total|Total of all reporting groups
226894|NCT01467583|B3|Baseline|Renal Failure, Not on Dialysis|"These are patients with acute kidney injury not yet on dialysis~Fondaparinux: 2.5 mg every 48 hours"
226895|NCT01467583|B2|Baseline|Renal Failure, on CRRT|Fondaparinux: 2.5 mg every 48 hours
226896|NCT01467583|B1|Baseline|Renal Failure, on Intermittent Hemodialysis (IHD)|"These are patients with renal failure, on intermittent dialysis~Fondaparinux: 2.5 mg every 48 hours"
226897|NCT01467583|P3|Participant Flow|Renal Failure, Not on Dialysis Fondaparinux: 2.5 mg q48 hr|"These are patients with acute kidney injury not yet on dialysis~Fondaparinux: 2.5 mg every 48 hours"
229017|NCT01461369|O2|Outcome|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
226898|NCT01467583|P2|Participant Flow|Renal Failure, on CRRT on Fondaparinux: 2.5 mg Every 48 Hours|These are renal failure patients, either acute or chronic on Fondaparinux: 2.5 mg every 48 hours
226899|NCT01467583|P1|Participant Flow|Renal Failure, on Intermittent Hemodialysis (IHD)|"These are patients with renal failure, on intermittent dialysis~Fondaparinux: 2.5 mg every 48 hours"
226900|NCT01467583|O3|Outcome|Renal Failure, Not on Dialysis|"These are patients with acute kidney injury not yet on dialysis, receiving fondaparinux 2.5 mg subcutaneously every 48 hours~Fondaparinux: 2.5 mg every 48 hours"
226901|NCT01467583|O2|Outcome|Renal Failure-renal Replacement Therapy|"These are patients with renal failure, either acute or chronic, receiving fondaparinux 2.5 mg subcutaneously every 48 hours~Fondaparinux: 2.5 mg every 48 hours"
226902|NCT01467583|O1|Outcome|Renal Failure on Intermittent Dialysis (IHD)|"These are patients with renal failure, on IHD, receiving fondaparinux 2.5 mg subcutaneously every 48 hours~Fondaparinux: 2.5 mg every 48 hours"
226903|NCT01467583|O3|Outcome|Renal Failure, Not on Dialysis|"These are patients with acute kidney injury not yet on dialysis~Fondaparinux: 2.5 mg every 48 hours"
226904|NCT01467583|O2|Outcome|Renal Failure-continuous Renal Replacement Therapy|These are renal failure patients, either acute or chronic, on continuous renal replacement therapy (CRRT), receiving Fondaparinux: 2.5 mg every 48 hours
226905|NCT01467583|O1|Outcome|Renal Failure, on Intermittent Hemodialysis (IHD)|"These are patients with renal failure, on intermittent dialysis~Fondaparinux: 2.5 mg every 48 hours"
226906|NCT01467583|E3|Reported Event|Renal Failure, Not on Dialysis|"These are patients with acute kidney injury not yet on dialysis~Fondaparinux: 2.5 mg every 48 hours"
226907|NCT01467583|E2|Reported Event|Renal Failure-continuous Renal Replacement Therapy|These are patients with renal failure, on continuous renal replacement therapy (CRRT), receiving Fondaparinux: 2.5 mg every 48 hours
226908|NCT01467583|E1|Reported Event|Renal Failure, on Intermittent Hemodialysis (IHD)|"These are patients with renal failure, on intermittent dialysis~Fondaparinux: 2.5 mg every 48 hours"
226909|NCT01467570|B3|Baseline|Total|Total of all reporting groups
226910|NCT01467570|B2|Baseline|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200 : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
226911|NCT01467570|B1|Baseline|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
226912|NCT01467570|P2|Participant Flow|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200 : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
226913|NCT01467570|P1|Participant Flow|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
226914|NCT01467570|O2|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200 : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
226915|NCT01467570|O1|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
226916|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
226917|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
226918|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
226919|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
226920|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
226921|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
226922|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
226923|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
226924|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
226925|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
226926|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
227083|NCT01466881|O1|Outcome|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
226927|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
226928|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
226929|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
226930|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
226931|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
226932|NCT01467570|O2|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200 : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
226933|NCT01467570|O1|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
226934|NCT01467570|E2|Reported Event|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
226935|NCT01467570|E1|Reported Event|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
226936|NCT01467557|B3|Baseline|Total|Total of all reporting groups
226937|NCT01467557|B2|Baseline|1-Day ACUVUE MOIST Contact Lens Users|"1-Day ACUVUE MOIST contact lens users~etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses"
226938|NCT01467557|B1|Baseline|1-Day ACUVUE TruEye Contact Lens Users|"1-Day ACUVUE TruEye contact lens users~narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses"
226939|NCT01467557|P2|Participant Flow|1-Day ACUVUE MOIST Contact Lens Users|"1-Day ACUVUE MOIST contact lens users~etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses"
226940|NCT01467557|P1|Participant Flow|1-Day ACUVUE TruEye Contact Lens Users|"1-Day ACUVUE TruEye contact lens users~narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses"
226941|NCT01467557|O2|Outcome|1-Day ACUVUE MOIST Contact Lens Users|"1-Day ACUVUE MOIST contact lens users~etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses.~Registered Wearers who had been recently fit with these daily disposable lenses."
226942|NCT01467557|O1|Outcome|1-Day ACUVUE TruEye Contact Lens Users|"1-Day ACUVUE TruEye contact lens users~narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses.~Registered Wearers who had been recently fit with these daily disposable lenses."
226943|NCT01467557|O2|Outcome|1-Day ACUVUE MOIST Contact Lens Users|"1-Day ACUVUE MOIST contact lens users~etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses.~Registered Wearers who had been recently fit with these daily disposable lenses."
226944|NCT01467557|O1|Outcome|1-Day ACUVUE TruEye Contact Lens Users|"1-Day ACUVUE TruEye contact lens users~narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses.~Registered Wearers who had been recently fit with these daily disposable lenses."
226945|NCT01467557|E2|Reported Event|1-Day ACUVUE MOIST Contact Lens Users|"1-Day ACUVUE MOIST contact lens users~etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses.~Registered Wearers who had been recently fit with these daily disposable lenses."
226946|NCT01467557|E1|Reported Event|1-Day ACUVUE TruEye Contact Lens Users|"1-Day ACUVUE TruEye contact lens users~narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses.~Registered Wearers who had been recently fit with these daily disposable lenses."
226947|NCT01467505|B3|Baseline|Total|Total of all reporting groups
226948|NCT01467505|B2|Baseline|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226949|NCT01467505|B1|Baseline|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226950|NCT01467505|P2|Participant Flow|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving cyclosporine (CsA) based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226964|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226951|NCT01467505|P1|Participant Flow|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving tacrolimus (TAC) based immunosuppressant regimen at baseline, received telaprevir (T) 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226952|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226953|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226954|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226955|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226956|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226957|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226958|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226959|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226960|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226961|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226962|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226963|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
227079|NCT01466881|B1|Baseline|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
227360|NCT01466387|B1|Baseline|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
226965|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226966|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226967|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226968|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226969|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226970|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226971|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226972|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226973|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226974|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226975|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226976|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226977|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226978|NCT01467505|E2|Reported Event|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226979|NCT01467505|E1|Reported Event|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
226980|NCT01467492|B3|Baseline|Total|Total of all reporting groups
226981|NCT01467492|B2|Baseline|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
226982|NCT01467492|B1|Baseline|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
226983|NCT01467492|P2|Participant Flow|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
226984|NCT01467492|P1|Participant Flow|Group A - Black|Black/African American participants received telaprevir 750 milligram (mg) tablet 3 times per day for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) (for participants weighing <75 kilograms [kg]) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
226985|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
226986|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
226987|NCT01467492|O1|Outcome|All Participants|All enrolled participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
226988|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
226989|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
226990|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
226991|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
226992|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
226993|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
226994|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
226995|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
226996|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
226997|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
227244|NCT01466595|P1|Participant Flow|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
226998|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
226999|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
227000|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
227001|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
227002|NCT01467492|E2|Reported Event|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
227003|NCT01467492|E1|Reported Event|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
227004|NCT01467479|B4|Baseline|Total|Total of all reporting groups
227005|NCT01467479|B3|Baseline|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227006|NCT01467479|B2|Baseline|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227007|NCT01467479|B1|Baseline|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227008|NCT01467479|P3|Participant Flow|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving raltegravir (RAL) based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227009|NCT01467479|P2|Participant Flow|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving efavirenz (EFV) based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227010|NCT01467479|P1|Participant Flow|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving atazanavir/ritonavir (ATV/r) based HAART at baseline, received Telaprevir (T)1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227011|NCT01467479|O1|Outcome|T/PR + HAART Regimen|Participants who were receiving either ATV/r based HAART or EFV based HAART or RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily or 1125 mg three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their respective HAART, as per standard practice and investigator discretion.
227012|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227013|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227014|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
261435|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
227015|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227016|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227017|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227018|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227019|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227020|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227021|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227022|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227023|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227024|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227025|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227026|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227027|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227028|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227029|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227080|NCT01466881|P1|Participant Flow|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
227081|NCT01466881|O2|Outcome|Responders|Eligible Patients who received protocol treatment and achieved complete or partial response.
227030|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227031|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227032|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227033|NCT01467479|E3|Reported Event|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227034|NCT01467479|E2|Reported Event|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227035|NCT01467479|E1|Reported Event|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
227036|NCT01467427|B3|Baseline|Total|Total of all reporting groups
227037|NCT01467427|B2|Baseline|Older Children (7-12 Years)|Subjects (7-12 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
227038|NCT01467427|B1|Baseline|Younger Children (0-6 Years)|Subjects (0-6 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
227039|NCT01467427|P2|Participant Flow|Older Children (7-12 Years)|Subjects (7-12 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
227040|NCT01467427|P1|Participant Flow|Younger Children (0-6 Years)|Subjects (0-6 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
227041|NCT01467427|O2|Outcome|Older Children (7-12 Years)|Subjects (7-12 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
227042|NCT01467427|O1|Outcome|Younger Children (0-6 Years)|Subjects (0-6 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
227043|NCT01467427|O2|Outcome|Older Children (7-12 Years)|Subjects (7-12 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
227044|NCT01467427|O1|Outcome|Younger Children (0-6 Years)|Subjects (0-6 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
227045|NCT01467427|O2|Outcome|Older Children (7-12 Years)|Subjects (7-12 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
227046|NCT01467427|O1|Outcome|Younger Children (0-6 Years)|Subjects (0-6 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
227082|NCT01466881|O1|Outcome|Non-responders|Eligible patients who received protocol treatment and did not respond to the protocol treatment. Patients for whom response assessment was inadequate were considered non-responders.
227047|NCT01467427|O2|Outcome|Older Children (7-12 Years)|Subjects (7-12 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
227048|NCT01467427|O1|Outcome|Younger Children (0-6 Years)|Subjects (0-6 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
227049|NCT01467427|O2|Outcome|Older Children (7-12 Years)|Subjects (7-12 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
227050|NCT01467427|O1|Outcome|Younger Children (0-6 Years)|Subjects (0-6 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
227051|NCT01467427|O2|Outcome|Older Children (7-12 Years)|Subjects (7-12 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
227052|NCT01467427|O1|Outcome|Younger Children (0-6 Years)|Subjects (0-6 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
227053|NCT01467427|O2|Outcome|Older Children (7-12 Years)|Subjects (7-12 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
227054|NCT01467427|O1|Outcome|Younger Children (0-6 Years)|Subjects (0-6 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
227055|NCT01467427|E2|Reported Event|Older Children (7 - 12 Years)|Subjects (7-12 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
227056|NCT01467427|E1|Reported Event|Younger Children (0 - 6 Years)|Subjects (0-6 years) received nonacog beta pegol 40 U/kg intravenous (i.v. once weekly for 52 weeks. Bleeding episodes were treated as soon as they were identified. The dose for treatment of an uncomplicated mild/moderate bleeding episode, e.g. a joint bleed, was a single dose of nonacog beta pegol 40 U/kg i.v. Severe bleeding episodes were treated immediately with 80 U/kg.
227057|NCT01467076|B4|Baseline|Total|Total of all reporting groups
227058|NCT01467076|B3|Baseline|High Dose IPGE1|300 ng/kg/min
227059|NCT01467076|B2|Baseline|Low Dose IPGE1|150 ng/kg/min
227060|NCT01467076|B1|Baseline|Control|Aerosolized saline
227061|NCT01467076|P3|Participant Flow|High Dose IPGE1|300 ng/kg/min
227062|NCT01467076|P2|Participant Flow|Low Dose IPGE1|150 ng/kg/min
227063|NCT01467076|P1|Participant Flow|Control|Aerosolized saline
227064|NCT01467076|O3|Outcome|High Dose IPGE1|300 ng/kg/min
227065|NCT01467076|O2|Outcome|Low Dose IPGE1|150 ng/kg/min
227066|NCT01467076|O1|Outcome|Control|Aerosolized saline
227067|NCT01467076|E3|Reported Event|High Dose IPGE1|300 ng/kg/min
227068|NCT01467076|E2|Reported Event|Low Dose IPGE1|150 ng/kg/min
227069|NCT01467076|E1|Reported Event|Control|Aerosolized saline
227070|NCT01467037|B3|Baseline|Total|Total of all reporting groups
227071|NCT01467037|B2|Baseline|Rotavirus -Positive|All stool were initially tested for rotavirus via enzyme immunoassay. Rotavirus-positives were confirmed via real-time reverse-transcriptase polymerase chain reactions (RT-PCR). RT-PCR results were used in the event of discordant EIA results. Rotavirus genotyping was performed.
227072|NCT01467037|B1|Baseline|Rotavirus-negative|All stool samples were initially tested for rotavirus via enzyme immunoassay. Patients with a negative result are included in this group.
227073|NCT01467037|P1|Participant Flow|Vaccine Effectiveness Study Population|Among patients eligible for active surveillance of acute gastroenteritis, patients aged <15 months at RV1 program implementation (November 1, 2011), AND aged ≥16 weeks at symptom onset
227074|NCT01467037|O2|Outcome|≥1 Versus 0 Dose|We compared Rotavirus VE between patients that received 1 versus 0 dose of RV1.
227075|NCT01467037|O1|Outcome|2 Versus 0 Doses|We compared Rotavirus VE between patients that received 2 versus 0 doses of RV1.
227076|NCT01467037|O2|Outcome|Rotavirus-positive|All stool were initially tested for rotavirus via enzyme immunoassay. Rotavirus positives were confirmed via realtime reversetranscriptase polymerase chain reactions (RTPCR). RTPCR results were used in the event of discordant EIA results. Rotavirus genotyping was performed.
227077|NCT01467037|O1|Outcome|Rotavirus-negative|All stool samples were initially tested for rotavirus via enzyme immunoassay. Patients with a negative result are included in this group.
227078|NCT01467037|E1|Reported Event|Vaccine Effectiveness Study Population|Among patients eligible for active surveillance of acute gastroenteritis, patients aged <15 months at RV1 program implementation (November 1, 2011), AND aged ≥16 weeks at symptom onset
261436|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
227084|NCT01466881|O1|Outcome|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
227085|NCT01466881|O1|Outcome|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
227086|NCT01466881|O1|Outcome|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
227087|NCT01466881|E1|Reported Event|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
227088|NCT01466790|B9|Baseline|Total|Total of all reporting groups
227089|NCT01466790|B8|Baseline|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
227090|NCT01466790|B7|Baseline|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
227091|NCT01466790|B6|Baseline|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
227092|NCT01466790|B5|Baseline|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
227093|NCT01466790|B4|Baseline|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
227094|NCT01466790|B3|Baseline|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
227095|NCT01466790|B2|Baseline|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
227096|NCT01466790|B1|Baseline|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
227097|NCT01466790|P8|Participant Flow|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
227098|NCT01466790|P7|Participant Flow|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
227099|NCT01466790|P6|Participant Flow|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
227100|NCT01466790|P5|Participant Flow|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
227101|NCT01466790|P4|Participant Flow|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
227102|NCT01466790|P3|Participant Flow|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
227103|NCT01466790|P2|Participant Flow|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
227104|NCT01466790|P1|Participant Flow|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
227105|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
227106|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
227107|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
227108|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
227109|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
227110|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
227111|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
227112|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
227113|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
227114|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
227115|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
227116|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
227117|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
227118|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
227119|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
227120|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
227121|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
227122|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
227123|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
227124|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
227125|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
227126|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
227127|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
227128|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
227129|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
227130|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
227131|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
227132|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
227133|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
227134|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
227135|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
227136|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
227137|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
227138|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
227139|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
227140|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
227141|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
227142|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
227143|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
227144|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
227145|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
227146|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
227147|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
227245|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227540|NCT01466127|P1|Participant Flow|Placebo|"Matched nasal spray placebo.~Placebo: Matched nasal spray placebo"
227148|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
227149|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
227150|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
227151|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
227152|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
227153|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
227154|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
227155|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
227156|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
227157|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
227158|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
227159|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
227160|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
227161|NCT01466790|E4|Reported Event|Cohort 1 and 2: TMC435 and PSI-7977 for 12 Weeks|Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
227162|NCT01466790|E3|Reported Event|Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
227163|NCT01466790|E2|Reported Event|Cohort 1 and 2: TMC435 and PSI-7977 for 24 Weeks|Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
227164|NCT01466790|E1|Reported Event|Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
227165|NCT01466764|B3|Baseline|Total|Total of all reporting groups
227166|NCT01466764|B2|Baseline|Saline Injection|"Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery."
227167|NCT01466764|B1|Baseline|Anakinra|"Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery."
227168|NCT01466764|P2|Participant Flow|Saline Injection|"Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery."
229018|NCT01461369|O1|Outcome|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
227169|NCT01466764|P1|Participant Flow|Anakinra|"Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery."
227170|NCT01466764|O2|Outcome|Saline Injection|"Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery."
227171|NCT01466764|O1|Outcome|Anakinra|"Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery."
227172|NCT01466764|O2|Outcome|Saline Injection|"Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery."
227173|NCT01466764|O1|Outcome|Anakinra|"Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery."
227174|NCT01466764|O2|Outcome|Saline Injection|"Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery."
227175|NCT01466764|O1|Outcome|Anakinra|"Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery."
227176|NCT01466764|O2|Outcome|Saline Injection|"Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery."
227177|NCT01466764|O1|Outcome|Anakinra|"Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery."
227178|NCT01466764|O2|Outcome|Saline Injection|"Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery."
227179|NCT01466764|O1|Outcome|Anakinra|"Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery."
227180|NCT01466764|O2|Outcome|Saline Injection|"Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery."
227181|NCT01466764|O1|Outcome|Anakinra|"Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery."
227182|NCT01466764|O2|Outcome|Saline Injection|"Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery."
227183|NCT01466764|O1|Outcome|Anakinra|"Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery."
227184|NCT01466764|E2|Reported Event|Saline Injection|"Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery."
227185|NCT01466764|E1|Reported Event|Anakinra|"Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.~Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery."
227186|NCT01466673|B3|Baseline|Total|Total of all reporting groups
227187|NCT01466673|B2|Baseline|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
227188|NCT01466673|B1|Baseline|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
227189|NCT01466673|P2|Participant Flow|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
227190|NCT01466673|P1|Participant Flow|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
227191|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
227246|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227192|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
227193|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
227194|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
227195|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
227196|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
227197|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
227198|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
227199|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
227200|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
227201|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
227202|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
227203|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
227204|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
227205|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
227206|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
227207|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
227208|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
227209|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
227210|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
227211|NCT01466673|E2|Reported Event|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
227212|NCT01466673|E1|Reported Event|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
227213|NCT01466660|B3|Baseline|Total|Total of all reporting groups
227214|NCT01466660|B2|Baseline|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
227215|NCT01466660|B1|Baseline|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40mg, dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
227216|NCT01466660|P2|Participant Flow|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
227217|NCT01466660|P1|Participant Flow|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40 milligram (mg), dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
227218|NCT01466660|O2|Outcome|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
227219|NCT01466660|O1|Outcome|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40mg, dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
227220|NCT01466660|O2|Outcome|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
227221|NCT01466660|O1|Outcome|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40mg, dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
227222|NCT01466660|O2|Outcome|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
227223|NCT01466660|O1|Outcome|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40mg, dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
227224|NCT01466660|O2|Outcome|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
227225|NCT01466660|O1|Outcome|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40mg, dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
227226|NCT01466660|O2|Outcome|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
227227|NCT01466660|O1|Outcome|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40mg, dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
227228|NCT01466660|O2|Outcome|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
227229|NCT01466660|O1|Outcome|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40mg, dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
227230|NCT01466660|O2|Outcome|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
227231|NCT01466660|O1|Outcome|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40mg, dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
227232|NCT01466660|O2|Outcome|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
227233|NCT01466660|O1|Outcome|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40mg, dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
227234|NCT01466660|O2|Outcome|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
227235|NCT01466660|O1|Outcome|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40mg, dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
227236|NCT01466660|O2|Outcome|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
227237|NCT01466660|O1|Outcome|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40mg, dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
227238|NCT01466660|E2|Reported Event|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
227239|NCT01466660|E1|Reported Event|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40mg, dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
227240|NCT01466595|B3|Baseline|Total|Total of all reporting groups
227241|NCT01466595|B2|Baseline|Arm B: No Study Treatment|No study treatment for 4 weeks
227242|NCT01466595|B1|Baseline|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227243|NCT01466595|P2|Participant Flow|Arm B: No Study Treatment|No study treatment for 4 weeks
227248|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227249|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227250|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227251|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227252|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227253|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227254|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227255|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227256|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227257|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227258|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227259|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227260|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227261|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227262|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227263|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227264|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227265|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227266|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227267|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227268|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227269|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227270|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227271|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227272|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227273|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227274|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227275|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227276|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227277|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227278|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227279|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227280|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227281|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227282|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227283|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227284|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227285|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227286|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227287|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227288|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227289|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227290|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227291|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227292|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227293|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227294|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227295|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227296|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227297|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227544|NCT01466127|E1|Reported Event|Placebo|"Matched nasal spray placebo.~Placebo: Matched nasal spray placebo"
227298|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227299|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227300|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227301|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227302|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227303|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227304|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227305|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227306|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227307|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227308|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227309|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227310|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227311|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227312|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227313|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227314|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227315|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227316|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227317|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227318|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227319|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227320|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227321|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227322|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227323|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227324|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227325|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227326|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227327|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227328|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227329|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
227330|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227331|NCT01466595|E2|Reported Event|Arm B: No Study Treatment|No study treatment for 4 weeks
227332|NCT01466595|E1|Reported Event|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
227333|NCT01466491|B5|Baseline|Total|Total of all reporting groups
227334|NCT01466491|B4|Baseline|4-site PCB Followed by no Wait|"Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
227335|NCT01466491|B3|Baseline|4-Site PCB Followed by 3-minute Wait|"Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
227357|NCT01466387|B4|Baseline|JE+Rabies+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
227358|NCT01466387|B3|Baseline|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine.
227359|NCT01466387|B2|Baseline|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
227336|NCT01466491|B2|Baseline|2-site Injection|"The superior technique of Phase 1 will be compared to a 2-site technique (2 mL injected at the tenaculum site, 18 mL equally distributed between 4 and 8 o’clock) in a randomized fashion (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
227337|NCT01466491|B1|Baseline|4-site Injection|"The superior technique of Phase 1 will be compared to a 4-site technique (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
227338|NCT01466491|P4|Participant Flow|4-site PCB Followed by no Wait|"Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
227339|NCT01466491|P3|Participant Flow|4-Site PCB Followed by 3-minute Wait|"Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
227340|NCT01466491|P2|Participant Flow|2-site Injection|"The superior technique of Phase 1 will be compared to a 2-site technique (2 mL injected at the tenaculum site, 18 mL equally distributed between 4 and 8 o’clock) in a randomized fashion (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
227341|NCT01466491|P1|Participant Flow|4-site Injection|"The superior technique of Phase 1 will be compared to a 4-site technique (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
227342|NCT01466491|O4|Outcome|4-site PCB Followed by no Wait|"Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
227343|NCT01466491|O3|Outcome|4-Site PCB Followed by 3-minute Wait|"Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
227353|NCT01466491|E1|Reported Event|4-site Injection|"The superior technique of Phase 1 will be compared to a 4-site technique (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
227354|NCT01466387|B7|Baseline|Total|Total of all reporting groups
227344|NCT01466491|O2|Outcome|2-site Injection|"The superior technique of Phase 1 will be compared to a 2-site technique (2 mL injected at the tenaculum site, 18 mL equally distributed between 4 and 8 o’clock) in a randomized fashion (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
227345|NCT01466491|O1|Outcome|4-site Injection|"The superior technique of Phase 1 will be compared to a 4-site technique (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
227346|NCT01466491|O4|Outcome|4-site PCB Followed by no Wait|"Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
227347|NCT01466491|O3|Outcome|4-Site PCB Followed by 3-minute Wait|"Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
227348|NCT01466491|O2|Outcome|2-site Injection|"The superior technique of Phase 1 will be compared to a 2-site technique (2 mL injected at the tenaculum site, 18 mL equally distributed between 4 and 8 o’clock) in a randomized fashion (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
227349|NCT01466491|O1|Outcome|4-site Injection|"The superior technique of Phase 1 will be compared to a 4-site technique (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
227350|NCT01466491|E4|Reported Event|4-site PCB Followed by no Wait|"Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
227351|NCT01466491|E3|Reported Event|4-Site PCB Followed by 3-minute Wait|"Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
227352|NCT01466491|E2|Reported Event|2-site Injection|"The superior technique of Phase 1 will be compared to a 2-site technique (2 mL injected at the tenaculum site, 18 mL equally distributed between 4 and 8 o’clock) in a randomized fashion (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).~Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
227361|NCT01466387|P6|Participant Flow|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
227362|NCT01466387|P5|Participant Flow|Rabies|Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine.
227363|NCT01466387|P4|Participant Flow|JE+Rabies+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
227364|NCT01466387|P3|Participant Flow|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine.
227365|NCT01466387|P2|Participant Flow|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
227366|NCT01466387|P1|Participant Flow|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
227367|NCT01466387|O2|Outcome|JE + Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
227368|NCT01466387|O1|Outcome|JE + Rabies + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
227369|NCT01466387|O3|Outcome|Rabies|Subjects ≥18 years to ≤60 yars of age who received three doses of Rabies vaccine.
227370|NCT01466387|O2|Outcome|JE + Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
227371|NCT01466387|O1|Outcome|JE + Rabies + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
227372|NCT01466387|O3|Outcome|Rabies|Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine
227373|NCT01466387|O2|Outcome|JE + Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of rabies vaccine.
227374|NCT01466387|O1|Outcome|JE + Rabies + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
227375|NCT01466387|O2|Outcome|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
227376|NCT01466387|O1|Outcome|JE + Rab + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
227377|NCT01466387|O2|Outcome|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
227378|NCT01466387|O1|Outcome|JE + Rab + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
227379|NCT01466387|O2|Outcome|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
227380|NCT01466387|O1|Outcome|TF + YF + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
227381|NCT01466387|O2|Outcome|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
227382|NCT01466387|O1|Outcome|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
227383|NCT01466387|O2|Outcome|JE+Rabies+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine and one dose of Meningococcal conjugate vaccine.
227384|NCT01466387|O1|Outcome|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
227385|NCT01466387|O2|Outcome|JE+Rabies+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
227386|NCT01466387|O1|Outcome|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
227387|NCT01466387|O2|Outcome|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
227388|NCT01466387|O1|Outcome|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
227389|NCT01466387|O2|Outcome|JE+Rab+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine and one dose of Meningococcal conjugate vaccine.
227390|NCT01466387|O1|Outcome|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
227391|NCT01466387|O2|Outcome|JE+Rab+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine and one dose of Meningococcal conjugate vaccine.
227392|NCT01466387|O1|Outcome|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
227393|NCT01466387|O2|Outcome|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
227394|NCT01466387|O1|Outcome|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
227395|NCT01466387|O2|Outcome|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
227396|NCT01466387|O1|Outcome|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
227397|NCT01466387|E6|Reported Event|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
227398|NCT01466387|E5|Reported Event|Rabies|Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine.
227399|NCT01466387|E4|Reported Event|JE+Rabies+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
227400|NCT01466387|E3|Reported Event|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine.
227401|NCT01466387|E2|Reported Event|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
227402|NCT01466387|E1|Reported Event|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
227403|NCT01466361|B5|Baseline|Total|Total of all reporting groups
227404|NCT01466361|B4|Baseline|Placebo Lozenge 2 (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
227405|NCT01466361|B3|Baseline|Nicotine Lozenge 1.5mg (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
227406|NCT01466361|B2|Baseline|Placebo Lozenge 1 (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
227407|NCT01466361|B1|Baseline|Nicotine Lozenge 4 mg (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
227408|NCT01466361|P4|Participant Flow|Placebo Lozenge (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
227409|NCT01466361|P3|Participant Flow|Nicotine Lozenge 1.5mg (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
227410|NCT01466361|P2|Participant Flow|Placebo Lozenge (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
227411|NCT01466361|P1|Participant Flow|Nicotine Lozenge 4 Milligrams (mg) (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
227412|NCT01466361|O4|Outcome|Placebo Lozenge 2 (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
227413|NCT01466361|O3|Outcome|Nicotine Lozenge 1.5mg (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
227414|NCT01466361|O2|Outcome|Placebo Lozenge 1 (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
227415|NCT01466361|O1|Outcome|Nicotine Lozenge 4 mg (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
227416|NCT01466361|O2|Outcome|Heavy Smokers Group|Participants smoking more than 20 cigarettes per day at baseline and responded to nicotine craving provocative paradigm before treatment
227417|NCT01466361|O1|Outcome|Light Smokers Group|Participants smoking between 6-20 cigarettes per day at baseline and responded to nicotine craving provocative paradigm before treatment
227418|NCT01466361|O2|Outcome|Placebo Lozenge 1 (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
227419|NCT01466361|O1|Outcome|Nicotine Lozenge 4mg (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
227420|NCT01466361|O2|Outcome|Placebo Lozenge 2 (Light Smokers Group)|Participants smoking between 6-20 cigarettes/day, received a single dose of placebo lozenge, through oral route.
227421|NCT01466361|O1|Outcome|Nicotine Lozenge 1.5mg (Light Smokers Group)|Participants smoking between 6-20 cigarettes/day, received a single dose of 1.5mg nicotine lozenge, through oral route.
227422|NCT01466361|E4|Reported Event|Placebo Lozenge 2 (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
227423|NCT01466361|E3|Reported Event|Placebo Lozenge 1 (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
227424|NCT01466361|E2|Reported Event|Nicotine Lozenge 4mg (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
227425|NCT01466361|E1|Reported Event|Nicotine Lozenge 1.5mg (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
227426|NCT01466348|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline measures.
227427|NCT01466348|P2|Participant Flow|Paracetamol Powder Then Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of paracetamol soluble powder (1000 mg), then 200 mL solution of two soluble tablets [each tablet containing 500 mg paracetamol and 65 mg of caffeine]. A washout period of 5 hours was maintained.
227428|NCT01466348|P1|Participant Flow|Paracetamol/ Caffeine Tablet Then Paracetamol Powder|Participants were orally administered with 200 millilitre (mL) solution of two soluble tablets, [each tablet containing 500 milligram (mg) paracetamol and 65 mg of caffeine], then 200 mL solution of paracetamol soluble powder (1000 mg). A washout period of 5 hours was maintained.
227429|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
227430|NCT01466348|O1|Outcome|Paracetamol/Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
227431|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
227432|NCT01466348|O1|Outcome|Paracetamol/Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
227433|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
227434|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine
229019|NCT01461369|O3|Outcome|Placebo|Placebo: Capsule
227435|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
227436|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
227437|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
227438|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
227439|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
227440|NCT01466348|O1|Outcome|Paracetamol/Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
227441|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
227442|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
227443|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
227444|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
227445|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
227446|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
227447|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
227448|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine
227449|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
227450|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
227451|NCT01466348|E2|Reported Event|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
227452|NCT01466348|E1|Reported Event|Paracetamol/Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
227453|NCT01466270|B3|Baseline|Total|Total of all reporting groups
227454|NCT01466270|B2|Baseline|Arm II - Placebo|Patients receive placebo PO QD.
227455|NCT01466270|B1|Baseline|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
227456|NCT01466270|P2|Participant Flow|Arm II - Placebo|Patients receive placebo PO QD.
227457|NCT01466270|P1|Participant Flow|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
227458|NCT01466270|O2|Outcome|Arm II - Placebo|Patients receive placebo PO QD.
227459|NCT01466270|O1|Outcome|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
227460|NCT01466270|O2|Outcome|Arm II - Placebo|Patients receive placebo PO QD.
227461|NCT01466270|O1|Outcome|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
227462|NCT01466270|O2|Outcome|Arm II - Placebo|Patients receive placebo PO QD.
227463|NCT01466270|O1|Outcome|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
227464|NCT01466270|O2|Outcome|Arm II|"Patients receive placebo PO QD.~Placebo: Given PO"
227465|NCT01466270|O1|Outcome|Arm I|"Patients receive donepezil hydrochloride PO QD.~donepezil hydrochloride: Given PO"
227466|NCT01466270|E2|Reported Event|Arm II - Placebo|Patients receive placebo PO QD.
227467|NCT01466270|E1|Reported Event|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
227468|NCT01466192|B1|Baseline|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
227469|NCT01466192|P1|Participant Flow|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
227470|NCT01466192|O1|Outcome|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
227471|NCT01466192|E1|Reported Event|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
227472|NCT01466179|B1|Baseline|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
227473|NCT01466179|P1|Participant Flow|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
227474|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
227475|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
227541|NCT01466127|O2|Outcome|Oxytocin|"Liquid intranasal oxytocin administered in a nasal spray.~Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once."
227476|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
227477|NCT01466179|O3|Outcome|Cycle 2: Blinatumomab 28 μg/Day|Participants receiving 28 μg/day blinatumomab by continuous intravenous (CIV) infusion during Cycle 2.
227478|NCT01466179|O2|Outcome|Cycle 1: Blinatumomab 28 μg/Day|Participants receiving 28 μg/day blinatumomab by continuous intravenous (CIV) infusion during Cycle 1.
227479|NCT01466179|O1|Outcome|Cycle 1: Blinatumomab 9 μg/Day|Participants receiving 9 μg/day blinatumomab by continuous intravenous (CIV) infusion during Cycle 1.
227480|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
227481|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
227482|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
227483|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
227484|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
227485|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
227486|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
227487|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
227488|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
227489|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
227490|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
227491|NCT01466179|E1|Reported Event|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The the initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
227492|NCT01466153|B4|Baseline|TOTAL|Total of all reporting groups
227493|NCT01466153|B3|Baseline|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227494|NCT01466153|B2|Baseline|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227495|NCT01466153|B1|Baseline|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
227496|NCT01466153|P3|Participant Flow|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227497|NCT01466153|P2|Participant Flow|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227498|NCT01466153|P1|Participant Flow|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
261437|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
227499|NCT01466153|O2|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227500|NCT01466153|O1|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227501|NCT01466153|O2|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227502|NCT01466153|O1|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227503|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227504|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227505|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
227506|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227507|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227508|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
227509|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227510|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227511|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
227512|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227513|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227514|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
227515|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227516|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227517|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
227542|NCT01466127|O1|Outcome|Placebo|"Matched nasal spray placebo.~Placebo: Matched nasal spray placebo"
227543|NCT01466127|E2|Reported Event|Oxytocin|"Liquid intranasal oxytocin administered in a nasal spray.~Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once."
227518|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227519|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227520|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
227521|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227522|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227523|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
227524|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227525|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227526|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
227527|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227528|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227529|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
227530|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227531|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227532|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
227533|NCT01466153|E3|Reported Event|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227534|NCT01466153|E2|Reported Event|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
227535|NCT01466153|E1|Reported Event|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
227536|NCT01466127|B3|Baseline|Total|Total of all reporting groups
227537|NCT01466127|B2|Baseline|Oxytocin|"Liquid intranasal oxytocin administered in a nasal spray.~Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once."
227538|NCT01466127|B1|Baseline|Placebo|"Matched nasal spray placebo.~Placebo: Matched nasal spray placebo"
227539|NCT01466127|P2|Participant Flow|Oxytocin|"Liquid intranasal oxytocin administered in a nasal spray.~Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once."
227545|NCT01466075|B1|Baseline|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.~Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
227546|NCT01466075|P1|Participant Flow|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.~Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
227547|NCT01466075|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.~Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
227548|NCT01466075|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.~Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
227549|NCT01466075|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.~Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
227550|NCT01466075|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.~Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
227551|NCT01466075|E1|Reported Event|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.~Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
227552|NCT01466062|B1|Baseline|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
227553|NCT01466062|P1|Participant Flow|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
227554|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
227555|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
227556|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
227557|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
227558|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
227559|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
227560|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
227561|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
227562|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
227563|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
227564|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
227565|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
227566|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
227567|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
227568|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
227569|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
227570|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
227571|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
227572|NCT01466062|E1|Reported Event|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
227573|NCT01465997|B3|Baseline|Total Title|
227574|NCT01465997|B2|Baseline|Carbamazepine-Controlled Release (CBZ-CR)|200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
227575|NCT01465997|B1|Baseline|Lacosamide|50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
227576|NCT01465997|P2|Participant Flow|Carbamazepine-Controlled Release (CBZ-CR)|200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
227577|NCT01465997|P1|Participant Flow|Lacosamide|50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
227578|NCT01465997|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
227579|NCT01465997|O1|Outcome|Lacosamide|50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
227580|NCT01465997|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
227581|NCT01465997|O1|Outcome|Lacosamide|50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
227582|NCT01465997|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR) (SS)|200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
227583|NCT01465997|O1|Outcome|Lacosamide (SS)|50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
227584|NCT01465997|E2|Reported Event|Carbamazepine-Controlled Release (CBZ-CR) (SS)|200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
227585|NCT01465997|E1|Reported Event|Lacosamide (SS)|50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
227586|NCT01465958|B1|Baseline|Safety Population|The safety population consisted of all subjects who received any amount of GAMUNEX-C. In the Run-in Phase, subjects received intravenous infusions of Gamunex-C at a dose between 200 to 600 mg/kg every three or four weeks for 3 months. In the subsequent IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks. In the SC Phase, subjects received weekly subcutaneous infusion of Gamunex-C at a mg/kg dose based on intravenous dose of the subject and dosing interval x 1.37 conversion factor for 12 weeks.
227587|NCT01465958|P2|Participant Flow|Subcutaneous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified: weekly subcutaneous infusion at a mg/kg dose based on intravenous dose of subject and dosing interval x 1.37 conversion factor for 12 weeks.
227588|NCT01465958|P1|Participant Flow|Intravenous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified: In the Run-in Phase, subjects received intravenous infusions of Gamunex-C at a dose between 200 to 600 mg/kg every three or four weeks for 3 months. In the subsequent IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks.
227589|NCT01465958|O2|Outcome|Subcutaneous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Subcutaneous Administration: weekly subcutaneous infusion at a mg/kg dose based on intravenous dose and dosing interval x 1.37 conversion factor for 12 weeks.
227668|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
227590|NCT01465958|O1|Outcome|Intravenous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Intravenous Administration: Two intravenous infusions at a dose of 200-600 mg/kg per intravenous infusion every 3-4 weeks for 4 to 5 weeks.
227591|NCT01465958|O2|Outcome|Subcutaneous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Subcutaneous Administration: weekly subcutaneous infusion at a mg/kg dose based on intravenous dose and dosing interval x 1.37 conversion factor for 12 weeks.
227592|NCT01465958|O1|Outcome|Intravenous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Intravenous Administration: In the IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks.
227593|NCT01465958|E2|Reported Event|Subcutaneous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Subcutaneous Administration: weekly subcutaneous infusion at a mg/kg dose based on intravenous dose and dosing interval x 1.37 conversion factor for 12 weeks.
227594|NCT01465958|E1|Reported Event|Intravenous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified: In the Run-in Phase, subjects received intravenous infusions of Gamunex-C at a dose between 200 to 600 mg/kg every three or four weeks for 3 months. In the subsequent IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks.
227595|NCT01465802|B6|Baseline|Total|Total of all reporting groups
227596|NCT01465802|B5|Baseline|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
227597|NCT01465802|B4|Baseline|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
227598|NCT01465802|B3|Baseline|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
227599|NCT01465802|B2|Baseline|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
227600|NCT01465802|B1|Baseline|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
227601|NCT01465802|P5|Participant Flow|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
227602|NCT01465802|P4|Participant Flow|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
227603|NCT01465802|P3|Participant Flow|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05 percent (%) applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
227604|NCT01465802|P2|Participant Flow|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
227605|NCT01465802|P1|Participant Flow|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 milligram (mg) tablets orally (PO) taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
227606|NCT01465802|O5|Outcome|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
227607|NCT01465802|O4|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
227669|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
227608|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
227609|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
227610|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
227611|NCT01465802|O5|Outcome|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
227612|NCT01465802|O4|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
227613|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
227614|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
227615|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
227616|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
227617|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
227618|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
227619|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
227620|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
227621|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
227622|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
227623|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
227624|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
227625|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
227670|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
229020|NCT01461369|O2|Outcome|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
227626|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
227627|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
227628|NCT01465802|O1|Outcome|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
227629|NCT01465802|O1|Outcome|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
227630|NCT01465802|O1|Outcome|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
227631|NCT01465802|O5|Outcome|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
227632|NCT01465802|O4|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
227633|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
227634|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
227635|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
227636|NCT01465802|O1|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
227637|NCT01465802|O1|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
227638|NCT01465802|O1|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
227639|NCT01465802|O1|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
227640|NCT01465802|O1|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
227641|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
227642|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
227643|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
227644|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
227645|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
227646|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
227647|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
227648|NCT01465802|E5|Reported Event|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
227649|NCT01465802|E4|Reported Event|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
227650|NCT01465802|E3|Reported Event|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
227651|NCT01465802|E2|Reported Event|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
227652|NCT01465802|E1|Reported Event|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
227653|NCT01465763|B4|Baseline|Total|Total of all reporting groups
227654|NCT01465763|B3|Baseline|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
227655|NCT01465763|B2|Baseline|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
227656|NCT01465763|B1|Baseline|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
227657|NCT01465763|P3|Participant Flow|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
227658|NCT01465763|P2|Participant Flow|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
227659|NCT01465763|P1|Participant Flow|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
227660|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
227661|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
227662|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
227663|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
227664|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
227665|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
227666|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
227667|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
229021|NCT01461369|O1|Outcome|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
227671|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
227672|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
227673|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
227674|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
227675|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
227676|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
227677|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
227678|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
227679|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
227680|NCT01465763|E3|Reported Event|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
227681|NCT01465763|E2|Reported Event|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
227682|NCT01465763|E1|Reported Event|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
227683|NCT01465412|B5|Baseline|Total|Total of all reporting groups
227684|NCT01465412|B4|Baseline|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
227685|NCT01465412|B3|Baseline|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
227686|NCT01465412|B2|Baseline|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
227687|NCT01465412|B1|Baseline|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
227688|NCT01465412|P4|Participant Flow|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
227689|NCT01465412|P3|Participant Flow|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
227690|NCT01465412|P2|Participant Flow|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
227691|NCT01465412|P1|Participant Flow|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
227692|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
227693|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
227694|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
227695|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
227696|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
227697|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
227698|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
227699|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
227700|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
227701|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
227702|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
227703|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
227704|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
227705|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
227706|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
227707|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
227708|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
227709|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
227710|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
227711|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
227712|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
227713|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
227714|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
227715|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
227716|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
227717|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
227718|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
227719|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
227720|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
227721|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
227722|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
227723|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
227724|NCT01465412|E4|Reported Event|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
227725|NCT01465412|E3|Reported Event|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
227726|NCT01465412|E2|Reported Event|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
227727|NCT01465412|E1|Reported Event|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
227728|NCT01465386|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~bortezomib: Given SC"
227729|NCT01465386|P1|Participant Flow|Treated Patients|"Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~bortezomib: Given SC"
227730|NCT01465386|O1|Outcome|Treated Patients|"Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~bortezomib: Given SC"
227731|NCT01465386|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|"Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~bortezomib: Given SC"
227732|NCT01465347|B1|Baseline|TSC 0.25 mg/kg for 9 or 18 Doses|Trans Sodium Crocetinate (TSC): TSC administered intravenously as a bolus injection prior to radiation therapy sessions during 6 weeks of radiotherapy.
227733|NCT01465347|P2|Participant Flow|TSC 0.25 mg/kg - 18 Dose Group|Phase 2: 6 weeks of TSC (18 doses in total) with concomitant RT and temozolomide for 6 weeks
227734|NCT01465347|P1|Participant Flow|TSC 0.25 mg/kg - 9 Dose Group|Phase 1: 3 weeks of TSC (9 doses in total) with concomitant RT and temozolomide for 6 weeks
227735|NCT01465347|O2|Outcome|TSC 0.25 mg/kg - 18 Dose Group - Phase 2|Trans Sodium Crocetinate (TSC): TSC administered intravenously for 18 doses as a bolus injection prior to radiation therapy sessions during 6 weeks of radiotherapy.
227784|NCT01465022|O2|Outcome|Progestin-only Pill|"Study Arm B is one of two interventions (Progestin-only pill)~Progestin-only pill: .35 mg norethindrone once a day orally"
228082|NCT01464229|P2|Participant Flow|Placebo, Then Iloperidone|Placebo: Placebo for 4 weeks, then iloperidone for 4 weeks; in addition to standard SSRI antidepressant
227736|NCT01465347|O1|Outcome|TSC 0.25mg/kg - 9 Dose Group - Phase 1|Phase 1 was the safety lead-in portion of the study conducted to evaluate an initial TSC dosage regimen in a smaller number of subjects and for a shorter period before a larger number of subjects were studied for a longer period in phase 2. Three (3) subjects were dosed with TSC at 0.25mg/kg for 3 weeks for a total of 9 doses with monitoring for dose-limiting toxicity (DLT). A Safety Monitoring Committee (SMC) evaluated the safety data and recommended TSC 0.25mg/kg for phase 2.
227737|NCT01465347|O1|Outcome|TSC 0.25 mg/kg - 18 Dose Group - Phase 2|Trans Sodium Crocetinate (TSC): TSC administered intravenously for 18 doses as a bolus injection prior to radiation therapy sessions during 6 weeks of radiotherapy.
227738|NCT01465347|O1|Outcome|TSC 0.25 mg/kg - 18 Dose Group - Phase 2|Trans Sodium Crocetinate (TSC): TSC administered intravenously for 18 doses as a bolus injection prior to radiation therapy sessions during 6 weeks of radiotherapy.
227739|NCT01465347|O2|Outcome|TSC 0.25 mg/kg - 18 Dose Group|Phase 2: 6 weeks of TSC (18 doses in total) with concomitant RT and temozolomide for 6 weeks
227740|NCT01465347|O1|Outcome|TSC 0.25 mg/kg - 9 Dose Group|Phase 1: 3 weeks of TSC (9 doses in total) with concomitant RT and temozolomide for 6 weeks
227741|NCT01465347|E2|Reported Event|TSC 0.25 mg/kg - 18 Dose Group|Phase 2: 6 weeks of TSC (18 doses in total) with concomitant RT and temozolomide for 6 weeks
227742|NCT01465347|E1|Reported Event|TSC 0.25 mg/kg - 9 Dose Group|Phase 1: 3 weeks of TSC (9 doses in total) with concomitant RT and temozolomide for 6 weeks
227743|NCT01465230|B1|Baseline|Lenalidomide|"Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.~Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide"
227744|NCT01465230|P1|Participant Flow|Lenalidomide|"Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.~Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide"
227745|NCT01465230|O1|Outcome|Lenalidomide|"Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.~Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide"
227746|NCT01465230|E1|Reported Event|Lenalidomide|"Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.~Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide"
227747|NCT01465178|B3|Baseline|Total|Total of all reporting groups
227748|NCT01465178|B2|Baseline|Placebo|"Non-matching placebo, gelatin filled capsules~Placebo: matching placebo"
227749|NCT01465178|B1|Baseline|2000 IU Vitamin D3|"Cholecalciferol 2,000 IU capsules~cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily"
227750|NCT01465178|P2|Participant Flow|Placebo|"Non-matching placebo, gelatin filled capsules~Placebo: matching placebo"
227751|NCT01465178|P1|Participant Flow|2000 IU Vitamin D3|"Cholecalciferol 2,000 IU capsules~cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily"
227752|NCT01465178|O2|Outcome|Placebo|"Non-matching placebo, gelatin filled capsules~Placebo: matching placebo"
227753|NCT01465178|O1|Outcome|2000 IU Vitamin D3|"Cholecalciferol 2,000 IU capsules~cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily"
227754|NCT01465178|O2|Outcome|Placebo|"Non-matching placebo, gelatin filled capsules~Placebo: matching placebo"
227755|NCT01465178|O1|Outcome|2000 IU Vitamin D3|"Cholecalciferol 2,000 IU capsules~cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily"
227756|NCT01465178|E2|Reported Event|Placebo|"Non-matching placebo, gelatin filled capsules~Placebo: matching placebo"
227757|NCT01465178|E1|Reported Event|2000 IU Vitamin D3|"Cholecalciferol 2,000 IU capsules~cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily"
227758|NCT01465048|B4|Baseline|Total|Total of all reporting groups
227759|NCT01465048|B3|Baseline|PfSPZ Challenge 25,000 IM|
227760|NCT01465048|B2|Baseline|PfSPZ Challenge 2,500 IM|
227761|NCT01465048|B1|Baseline|PfSPZ Challenge 2,500 ID|
227762|NCT01465048|P3|Participant Flow|PfSPZ Challenge 25,000 IM|
227763|NCT01465048|P2|Participant Flow|PfSPZ Challenge 2,500 IM|
227764|NCT01465048|P1|Participant Flow|PfSPZ Challenge 2,500 ID|
227765|NCT01465048|O3|Outcome|PfSPZ Challenge 25,000 IM|
227766|NCT01465048|O2|Outcome|PfSPZ Challenge 2,500 IM|
227767|NCT01465048|O1|Outcome|PfSPZ Challenge 2,500 ID|
227768|NCT01465048|E3|Reported Event|PfSPZ Challenge 25,000 IM|
227769|NCT01465048|E2|Reported Event|PfSPZ Challenge 2,500 IM|
227770|NCT01465048|E1|Reported Event|PfSPZ Challenge 2,500 ID|
227771|NCT01465022|B4|Baseline|Total|Total of all reporting groups
227772|NCT01465022|B3|Baseline|Not Randomized|70 women who were enrolled.
227773|NCT01465022|B2|Baseline|Progestin-only Pill|Study Arm B is one of two interventions (POP).
227774|NCT01465022|B1|Baseline|Combined Estrogen-progestin Pill|Study Arm A is one of two interventions (OCP).
227775|NCT01465022|P3|Participant Flow|Not Randomized|Participants who were consented but not randomized.
227776|NCT01465022|P2|Participant Flow|Progestin-only Pill|Study Arm B is one of two interventions.
227777|NCT01465022|P1|Participant Flow|Combined Estrogen-progestin Pill|Study Arm A is one of two interventions.
227778|NCT01465022|O2|Outcome|Progestin-only Pill|"Study Arm B is one of two interventions (Progestin-only pill)~Progestin-only pill: .35 mg norethindrone once a day orally"
227779|NCT01465022|O1|Outcome|Combined Estrogen-progestin Pill|"Study Arm A is one of two interventions (Combined estrogen-progestin pill)~Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo"
227780|NCT01465022|O2|Outcome|Progestin-only Pill|"Study Arm B is one of two interventions (Progestin-only pill)~Progestin-only pill: .35 mg norethindrone once a day orally"
227781|NCT01465022|O1|Outcome|Combined Estrogen-progestin Pill|"Study Arm A is one of two interventions (Combined estrogen-progestin pill)~Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo"
227782|NCT01465022|O2|Outcome|Progestin-only Pill|"Study Arm B is one of two interventions (Progestin-only pill)~Progestin-only pill: .35 mg norethindrone once a day orally"
227783|NCT01465022|O1|Outcome|Combined Estrogen-progestin Pill|"Study Arm A is one of two interventions (Combined estrogen-progestin pill)~Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo"
227785|NCT01465022|O1|Outcome|Combined Estrogen-progestin Pill|"Study Arm A is one of two interventions (Combined estrogen-progestin pill)~Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo"
227786|NCT01465022|O2|Outcome|Progestin-only Pill|"Study Arm B is one of two interventions (Progestin-only pill)~Progestin-only pill: .35 mg norethindrone once a day orally"
227787|NCT01465022|O1|Outcome|Combined Estrogen-progestin Pill|"Study Arm A is one of two interventions (Combined estrogen-progestin pill)~Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo"
227788|NCT01465022|E2|Reported Event|Progestin-only Pill|"Study Arm B is one of two interventions (Progestin-only pill)~Progestin-only pill: .35 mg norethindrone once a day orally"
227789|NCT01465022|E1|Reported Event|Combined Estrogin-progestin Pill|"Study Arm A is one of two interventions (Combined estrogen-progestin pill)~Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo"
227790|NCT01464996|B1|Baseline|All Study Participants|Will include composite restorations placed using both dental adhesives OptiBond XTR and OptiBond FL.
227791|NCT01464996|P1|Participant Flow|All Study Participants|"Will include composite restorations placed using both the dental adhesive OptiBond XTR and OptiBond FL.~Participants were randomized to receive either type of intervention"
227792|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.~Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
227793|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.~Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
227794|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.~Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
227795|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.~Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
227796|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.~Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
227797|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.~Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
227798|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.~Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
227799|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.~Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
227800|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.~Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
227801|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.~Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
227802|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.~Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
227803|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.~Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
227804|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.~Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
227805|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.~Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
227806|NCT01464996|E2|Reported Event|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.~Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
227807|NCT01464996|E1|Reported Event|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.~Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
227808|NCT01464931|B3|Baseline|Total|Total of all reporting groups
227809|NCT01464931|B2|Baseline|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
227810|NCT01464931|B1|Baseline|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
227811|NCT01464931|P2|Participant Flow|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
227812|NCT01464931|P1|Participant Flow|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
227813|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
227814|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
227815|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
229022|NCT01461369|O3|Outcome|Placebo|Placebo: Capsule
227816|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
227817|NCT01464931|O2|Outcome|ESRD - Dose 2|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 29.
227818|NCT01464931|O1|Outcome|Severe CKD - Dose 2|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 29.
227819|NCT01464931|O2|Outcome|ESRD - Dose 1|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 1.
227820|NCT01464931|O1|Outcome|Severe CKD - Dose 1|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 1.
227821|NCT01464931|O4|Outcome|ESRD - Dose 2|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 29.
227822|NCT01464931|O3|Outcome|Severe CKD - Dose 2|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 29.
227823|NCT01464931|O2|Outcome|ESRD - Dose 1|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 1.
227824|NCT01464931|O1|Outcome|Severe CKD - Dose 1|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 1.
227825|NCT01464931|O4|Outcome|ESRD - Dose 2|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 29.
227826|NCT01464931|O3|Outcome|Severe CKD - Dose 2|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 29.
227827|NCT01464931|O2|Outcome|ESRD - Dose 1|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 1.
227828|NCT01464931|O1|Outcome|Severe CKD - Dose 1|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 1.
227829|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
227830|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
227831|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
227832|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
227833|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
227834|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
227835|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
227836|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
227837|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
227838|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
227839|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
227840|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
227841|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
227842|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
227843|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
227844|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
227845|NCT01464931|E3|Reported Event|Denosumab 120 mg - All Subjects|Participants received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
227846|NCT01464931|E2|Reported Event|Denosumab 120 mg - ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
227847|NCT01464931|E1|Reported Event|Denosumab 120 mg - Severe|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
227848|NCT01464879|B1|Baseline|Testosterone Topical|Initially study subjects self-applied 2.50 mL (two strokes) of testosterone gel by hand every day for seven days followed by a 7-day washout period. After washout period, study subjects sequentially self-applied ascending doses of testosterone gel with the applicator; 1.25 mL (one stroke), 2.50 mL (two strokes), and 3.75 mL (three strokes), respectively every day for seven days with no washout period in between.
227849|NCT01464879|P1|Participant Flow|Testosterone Topical|Initially subjects self-applied 2.50 mL (two strokes) of testosterone gel by hand every day for seven days followed by a 7-day washout period. After washout period, subjects sequentially self-applied ascending doses of testosterone gel with the applicator; 1.25 mL (one stroke), 2.50 mL (two strokes), and 3.75 mL (three strokes), respectively every day for seven days with no washout period in between.
227995|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received parenting intervention after completing 2 study visits 12 week apart.
227850|NCT01464879|O1|Outcome|Testosterone 2.50 mL (Hand)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
227851|NCT01464879|O1|Outcome|Testosterone 2.50 mL (Hand)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
227852|NCT01464879|O1|Outcome|Testosterone 2.50 mL (Hand)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
227853|NCT01464879|O1|Outcome|Testosterone 2.50 mL (Hand)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
227854|NCT01464879|O1|Outcome|Testosterone 2.50 mL (Hand)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
227855|NCT01464879|O1|Outcome|Testosterone 2.50 mL (Hand)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
227856|NCT01464879|O3|Outcome|Testosterone 3.75 mL (Applicator)|Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
227857|NCT01464879|O2|Outcome|Testosterone 2.50 mL (Applicator)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
227858|NCT01464879|O1|Outcome|Testosterone 1.25 mL (Applicator)|Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
227859|NCT01464879|O3|Outcome|Testosterone 3.75 mL (Applicator)|Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
227860|NCT01464879|O2|Outcome|Testosterone 2.50 mL (Applicator)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
227861|NCT01464879|O1|Outcome|Testosterone 1.25 mL (Applicator)|Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
227862|NCT01464879|O3|Outcome|Testosterone 3.75 mL (Applicator)|Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
227863|NCT01464879|O2|Outcome|Testosterone 2.50 mL (Applicator)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
227864|NCT01464879|O1|Outcome|Testosterone 1.25 mL (Applicator)|Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
227865|NCT01464879|O3|Outcome|Testosterone 3.75 mL (Applicator)|Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
227866|NCT01464879|O2|Outcome|Testosterone 2.50 mL (Applicator)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
227867|NCT01464879|O1|Outcome|Testosterone 1.25 mL (Applicator)|Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
227868|NCT01464879|O3|Outcome|Testosterone 3.75 mL (Applicator)|Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
227869|NCT01464879|O2|Outcome|Testosterone 2.50 mL (Applicator)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
227870|NCT01464879|O1|Outcome|Testosterone 1.25 mL (Applicator)|Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
227871|NCT01464879|O3|Outcome|Testosterone 3.75 mL (Applicator)|Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
227872|NCT01464879|O2|Outcome|Testosterone 2.50 mL (Applicator)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
227873|NCT01464879|O1|Outcome|Testosterone 1.25 mL (Applicator)|Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
227874|NCT01464879|O1|Outcome|Testosterone 2.50 mL (Hand)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
227875|NCT01464879|O3|Outcome|Testosterone 3.75 mL (Applicator)|Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
227996|NCT01464619|O1|Outcome|Intervention|Subjects received parenting intervention immediately
229023|NCT01461369|O2|Outcome|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
227876|NCT01464879|O2|Outcome|Testosterone 2.50 mL (Applicator)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
227877|NCT01464879|O1|Outcome|Testosterone 1.25 mL (Applicator)|Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
227878|NCT01464879|E4|Reported Event|Testosterone 3.75 mL (Applicator)|Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
227879|NCT01464879|E3|Reported Event|Testosterone 2.50 mL (Applicator)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
227880|NCT01464879|E2|Reported Event|Testosterone 1.25 mL (Applicator)|Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
227881|NCT01464879|E1|Reported Event|Testosterone 2.50 mL (Hand)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
227882|NCT01464840|B4|Baseline|Total|Total of all reporting groups
227883|NCT01464840|B3|Baseline|60 Minutes|"500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
227884|NCT01464840|B2|Baseline|30 Minutes|"500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
227885|NCT01464840|B1|Baseline|15 Minutes|"500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
227886|NCT01464840|P3|Participant Flow|60 Minutes|"500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
227887|NCT01464840|P2|Participant Flow|30 Minutes|"500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
227888|NCT01464840|P1|Participant Flow|15 Minutes|"500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
227889|NCT01464840|O3|Outcome|60 Minutes|"500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
227890|NCT01464840|O2|Outcome|15 Minutes|"500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
227891|NCT01464840|O1|Outcome|30 Minutes|"500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
227892|NCT01464840|E3|Reported Event|60 Minutes|"500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
227893|NCT01464840|E2|Reported Event|30 Minutes|"500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
227894|NCT01464840|E1|Reported Event|15 Minutes|"500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
227895|NCT01464827|B15|Baseline|Total|Total of all reporting groups
227896|NCT01464827|B14|Baseline|Group N|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
227897|NCT01464827|B13|Baseline|Group M|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
227898|NCT01464827|B12|Baseline|Group L|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
227899|NCT01464827|B11|Baseline|Group K|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
227900|NCT01464827|B10|Baseline|Group J|Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
227901|NCT01464827|B9|Baseline|Group I|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
227902|NCT01464827|B8|Baseline|Group H|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
227903|NCT01464827|B7|Baseline|Group G|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
227904|NCT01464827|B6|Baseline|Group F|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
227905|NCT01464827|B5|Baseline|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
227906|NCT01464827|B4|Baseline|Group D|Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
227907|NCT01464827|B3|Baseline|Group C|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
227908|NCT01464827|B2|Baseline|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
227909|NCT01464827|B1|Baseline|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks.
227910|NCT01464827|P14|Participant Flow|Group N|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
227911|NCT01464827|P13|Participant Flow|Group M|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
227912|NCT01464827|P12|Participant Flow|Group L|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
227913|NCT01464827|P11|Participant Flow|Group K|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
227914|NCT01464827|P10|Participant Flow|Group J|Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
227915|NCT01464827|P9|Participant Flow|Group I|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
227916|NCT01464827|P8|Participant Flow|Group H|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
227917|NCT01464827|P7|Participant Flow|Group G|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
227918|NCT01464827|P6|Participant Flow|Group F|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
227919|NCT01464827|P5|Participant Flow|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
227920|NCT01464827|P4|Participant Flow|Group D|Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
227921|NCT01464827|P3|Participant Flow|Group C|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
227922|NCT01464827|P2|Participant Flow|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
227923|NCT01464827|P1|Participant Flow|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks.
227924|NCT01464827|O2|Outcome|Groups K + L + M + N|Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 or 24 weeks.
227925|NCT01464827|O1|Outcome|Groups F + G + H + I|Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 or 24 weeks.
227926|NCT01464827|O2|Outcome|Groups F + G + K + L|Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
227927|NCT01464827|O1|Outcome|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily, for 12 weeks.
227928|NCT01464827|O3|Outcome|Groups F + G + K + L|Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
227929|NCT01464827|O2|Outcome|Groups C + D + J|Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 200 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
227930|NCT01464827|O1|Outcome|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
227931|NCT01464827|O3|Outcome|Groups H + I + M + N|Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
227932|NCT01464827|O2|Outcome|Groups F + G + K + L|Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
227933|NCT01464827|O1|Outcome|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 8 weeks.
227934|NCT01464827|O14|Outcome|Group N|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
227935|NCT01464827|O13|Outcome|Group M|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
227936|NCT01464827|O12|Outcome|Group L|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
229024|NCT01461369|O1|Outcome|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
227937|NCT01464827|O11|Outcome|Group K|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
227938|NCT01464827|O10|Outcome|Group J|Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
227939|NCT01464827|O9|Outcome|Group I|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
227940|NCT01464827|O8|Outcome|Group H|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
227941|NCT01464827|O7|Outcome|Group G|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
227942|NCT01464827|O6|Outcome|Group F|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
227943|NCT01464827|O5|Outcome|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
227944|NCT01464827|O4|Outcome|Group D|Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
227945|NCT01464827|O3|Outcome|Group C|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
227946|NCT01464827|O2|Outcome|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
227947|NCT01464827|O1|Outcome|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks.
227948|NCT01464827|O9|Outcome|Group M + N|Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
227949|NCT01464827|O8|Outcome|Group K + L|Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
227950|NCT01464827|O7|Outcome|Group J|Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
227951|NCT01464827|O6|Outcome|Group H + I|Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
227952|NCT01464827|O5|Outcome|Group F + G|Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
227953|NCT01464827|O4|Outcome|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
227954|NCT01464827|O3|Outcome|Group C + D|Treatment-naïve participants received ABT-450 (100 mg or 200 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
227955|NCT01464827|O2|Outcome|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
227956|NCT01464827|O1|Outcome|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 8 weeks.
227957|NCT01464827|E9|Reported Event|Group M + N|Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
227958|NCT01464827|E8|Reported Event|Group K + L|Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
227959|NCT01464827|E7|Reported Event|Group J|Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
227960|NCT01464827|E6|Reported Event|Group H + I|Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
227961|NCT01464827|E5|Reported Event|Group F + G|Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
227962|NCT01464827|E4|Reported Event|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
227963|NCT01464827|E3|Reported Event|Group C + D|Treatment-naïve participants received ABT-450 (100 mg or 200 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
227964|NCT01464827|E2|Reported Event|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
227965|NCT01464827|E1|Reported Event|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 8 weeks.
227966|NCT01464788|B4|Baseline|Total|Total of all reporting groups
227967|NCT01464788|B3|Baseline|Rt-PA (Alteplase)|rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
227968|NCT01464788|B2|Baseline|High Dose Argatroban + Rt-PA|100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
227969|NCT01464788|B1|Baseline|Low Dose Argatroban + Rt-PA|100 micrograms/kilogram bolus, followed by 1 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
227970|NCT01464788|P3|Participant Flow|Rt-PA (Alteplase) Only|Intravenous rt-PA (alteplase) 0.9mg/kg (max dose 90mg); 10% bolus and remaining over 1 hour.
227971|NCT01464788|P2|Participant Flow|High Dose Argatroban + Rt-PA (Alteplase)|"Argatroban: 100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours.~and~Intravenous rt-PA (alteplase) 0.9mg/kg (max dose 90mg); 10% bolus and remaining over 1 hour."
227972|NCT01464788|P1|Participant Flow|Low-dose Argatroban + Rt-PA (Alteplase)|"100 micrograms/kilogram bolus, followed by 1 micrograms/kilogram/minute IV infusion for 48 hours.~and~Intravenous rt-PA (alteplase) 0.9mg/kg (max dose 90mg); 10% bolus and remaining over 1 hour."
227973|NCT01464788|O3|Outcome|Rt-PA (Alteplase)|rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
227974|NCT01464788|O2|Outcome|High Dose Argatroban + Rt-PA (Alteplase)|100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
227975|NCT01464788|O1|Outcome|Low Dose Argatroban + Rt-PA (Alteplase)|100 micrograms/kilogram bolus, followed by 1 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
227976|NCT01464788|O3|Outcome|Rt-PA (Alteplase)|rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
227977|NCT01464788|O2|Outcome|High Dose Argatroban + Rt-PA|100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
227978|NCT01464788|O1|Outcome|Low Dose Argatroban + Rt-PA|100 micrograms/kilogram bolus, followed by 1 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
227979|NCT01464788|E3|Reported Event|Rt-PA (Alteplase)|rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
227980|NCT01464788|E2|Reported Event|High Dose Argatroban + Rt-PA|100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
227981|NCT01464788|E1|Reported Event|Low Dose Argatroban + Rt-PA|100 micrograms/kilogram bolus, followed by 1 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
227982|NCT01464619|B3|Baseline|Total|Total of all reporting groups
227983|NCT01464619|B2|Baseline|Intervention|"Caregivers assigned to the intervention arm will be assigned to the Incredible Years parenting intervention immediately after enrollment. They will also receive enhanced mental health referrals and monthly follow-up phone calls.~The Incredible Years Parenting Intervention: The Incredible Years Parents, Babies, and Toddlers Program is a validated group parenting education program, which has been adapted for use with depressed caregivers by inclusion of psychoeducational depression materials."
227984|NCT01464619|B1|Baseline|Delayed Intervention|"Those assigned to the delayed intervention arm will receive enhanced mental health referrals, monthly follow-up phone calls, and will be assigned to the parenting intervention 3-4 months after enrollment.~Delayed Intervention: Caregivers assigned to delayed intervention will be assigned to the Incredible Years parenting intervention 3-4 months after enrollment."
227985|NCT01464619|P2|Participant Flow|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
227986|NCT01464619|P1|Participant Flow|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
227987|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
227988|NCT01464619|O1|Outcome|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
227989|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
227990|NCT01464619|O1|Outcome|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
227991|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
227992|NCT01464619|O1|Outcome|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
227993|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
227994|NCT01464619|O1|Outcome|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
229025|NCT01461369|O3|Outcome|Placebo|Placebo: Capsule
227997|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
227998|NCT01464619|O1|Outcome|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
227999|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received parenting intervention after completing 2 study visits 12 week apart.
228000|NCT01464619|O1|Outcome|Intervention|Subjects received parenting intervention immediately
228001|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
228002|NCT01464619|O1|Outcome|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
228003|NCT01464619|E2|Reported Event|Delayed Intervention|Subjects received parenting intervention after completing 2 study visits 12 week apart.
228004|NCT01464619|E1|Reported Event|Intervention|Subjects received parenting intervention immediately
228005|NCT01464424|B1|Baseline|Overall|Travoprost 0.004% and bimatoprost 0.01% in cross-over fashion, as randomized, 6 weeks each
228006|NCT01464424|P2|Participant Flow|LUMIGAN, Then TRAVATAN|Bimatoprost 0.01% ophthalmic solution (LUMIGAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by travoprost 0.004% ophthalmic solution (TRAVATAN), same dose, same duration, as randomized, for a total duration of 12 weeks
228007|NCT01464424|P1|Participant Flow|TRAVATAN, Then LUMIGAN|Travoprost 0.004% ophthalmic solution (TRAVATAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by bimatoprost 0.01% ophthalmic solution (LUMIGAN), same dose, same duration, as randomized, for a total duration of 12 weeks
228008|NCT01464424|O2|Outcome|LUMIGAN|Bimatoprost 0.01% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
228009|NCT01464424|O1|Outcome|TRAVATAN|Travoprost 0.004% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
228010|NCT01464424|O2|Outcome|LUMIGAN|Bimatoprost 0.01% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
228011|NCT01464424|O1|Outcome|TRAVATAN|Travoprost 0.004% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
228012|NCT01464424|E2|Reported Event|LUMIGAN|Bimatoprost 0.01% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
228013|NCT01464424|E1|Reported Event|TRAVATAN|Travoprost 0.004% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
228014|NCT01464359|B1|Baseline|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
228015|NCT01464359|P1|Participant Flow|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
228016|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
228017|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
228027|NCT01464346|P3|Participant Flow|Enlite Sensor Buttock/Buttock|Subjects wearing 2 Enlite sensors in Buttock. Some subjects participated in Frequent Sampling Tests during the first 12 hours of days 1, 3 and 6 while others participated during the last 12 hours of days 1, 3, and 6.
228018|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
228019|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
228020|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
228021|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
228022|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
228023|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
228024|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
228025|NCT01464359|E1|Reported Event|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
228026|NCT01464346|B1|Baseline|All Subjects Entering the Study|All Subjects who provided consent, met inclusion/exclusion criteria and worn Enlite sensors
229026|NCT01461369|O2|Outcome|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
228028|NCT01464346|P2|Participant Flow|Enlite Sensor Abdomen/Buttock|Subjects wearing one Enlite sensor in Abdomen and one Enlite sensor in Buttock. Some subjects participated in Frequent Sampling Tests during the first 12 hours of days 1, 3 and 6 while others participated during the last 12 hours of days 1, 3, and 6.
228029|NCT01464346|P1|Participant Flow|Enlite Sensor Abdomen/Abdomen|Subjects wearing 2 Enlite sensors in abdomen. Some subjects participated in Frequent Sampling Tests during the first 12 hours of days 1, 3 and 6 while others participated during the last 12 hours of days 1, 3, and 6.
228030|NCT01464346|O1|Outcome|All Subjects With Buttock Insertion|All subjects who enrolled in the study and had sensors inserted in the buttock insertion area.
228031|NCT01464346|O1|Outcome|All Subjects With Buttock Insertion|All subjects that enrolled in the study who had sensors inserted in the buttock insertion site.
228032|NCT01464346|O1|Outcome|All Subjects With Abdomen Insertion|All subjects that enrolled in the study and had sensors inserted in the abdomen insertion area.
228033|NCT01464346|O1|Outcome|All Subjects With Abdomen Insertion|This group contains all subjects with sensors inserted in the abdomen
228034|NCT01464346|O1|Outcome|All Subjects|This group contains all subjects that enrolled in the study
228035|NCT01464346|O1|Outcome|All Subjects|This group contains all subjects that enrolled in the study
228036|NCT01464346|E1|Reported Event|All Completed Subjects|All subjects that completed the study
228037|NCT01464307|B3|Baseline|Total|Total of all reporting groups
228038|NCT01464307|B2|Baseline|Main Period: Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.~Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
228039|NCT01464307|B1|Baseline|Main Period: IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
228040|NCT01464307|P2|Participant Flow|Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.~Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
228041|NCT01464307|P1|Participant Flow|IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9 percent (%) Sodium Chloride (NaCl), 400 units, total volume 8.0 milliliter (mL); Mode of administration: intramuscular injection.~IncobotulinumtoxinA (400 Units): Open-Label Extension Period: All subjects receive three injection sessions of solution, prepared by reconstitution of powder with 0.9% NaCl, 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
228042|NCT01464307|O2|Outcome|Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.~Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
228043|NCT01464307|O1|Outcome|IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
228044|NCT01464307|O2|Outcome|Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.~Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
228045|NCT01464307|O1|Outcome|IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
228046|NCT01464307|O2|Outcome|Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.~Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
228047|NCT01464307|O1|Outcome|IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
228048|NCT01464307|O2|Outcome|Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.~Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
228049|NCT01464307|O1|Outcome|IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
228081|NCT01464229|B1|Baseline|Iloperidone, Then Placebo|Iloperidone: Iloperidone 1-8 mg for 4 weeks then placebo for 4 weeks, in addition to SSRI antidepressant
261438|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
228050|NCT01464307|E3|Reported Event|Open-Label Extension: IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Open-Label Extension Period: All subjects receive three injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
228051|NCT01464307|E2|Reported Event|Main Period: Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.~Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
228052|NCT01464307|E1|Reported Event|Main Period: IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
228053|NCT01464255|B3|Baseline|Total|Total of all reporting groups
228054|NCT01464255|B2|Baseline|Ocufilcon B Then Ocufilcon D|Participants were randomized to wear ocufilcon B lenses for 1 week and then crossed over to the ocufilcon D lens pair for 1 week.
228055|NCT01464255|B1|Baseline|Ocufilcon D Then Ocufilcon B|Participants were randomized to wear ocufilcon D lenses for 1 week and then crossed over to the ocufilcon B lens pair for 1 week.
228056|NCT01464255|P2|Participant Flow|Ocufulcon B Then Ocufilcon D|Participants were randomized to wear ocufilcon B lenses for 1 week and then crossed over to the ocufilcon D lens pair for 1 week.
228057|NCT01464255|P1|Participant Flow|Ocufilcon D Then Ocufilcon B|Participants were randomized to wear ocufilcon D lenses for 1 week and then crossed over to the ocufilcon B lens pair for 1 week.
228058|NCT01464255|O2|Outcome|Ocufilcon B Then Ocufilcon D|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
228059|NCT01464255|O1|Outcome|Ocufilcon D Then Ocufilcon B|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
228060|NCT01464255|O2|Outcome|Ocufilcon B Then Ocufilcon D|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
228061|NCT01464255|O1|Outcome|Ocufilcon D Then Ocufilcon B|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
228062|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
228063|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
228064|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
228065|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
228066|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
228067|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
228068|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
228069|NCT01464255|O2|Outcome|Ocufilcon B Then Ocufilcon D|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
228070|NCT01464255|O1|Outcome|Ocufilcon D Then Ocufilcon B|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
228071|NCT01464255|O2|Outcome|Ocufilcon B Then Ocufilcon D|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
228072|NCT01464255|O1|Outcome|Ocufilcon D Then Ocufilcon B|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
228073|NCT01464255|O2|Outcome|Ocufilcon B Then Ocufilcon D|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
228074|NCT01464255|O1|Outcome|Ocufilcon D Then Ocufilcon B|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
228075|NCT01464255|O2|Outcome|Ocufilcon B Then Ocufilcon D|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
228076|NCT01464255|O1|Outcome|Ocufilcon D Then Ocufilcon B|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
228077|NCT01464255|E2|Reported Event|Ocufilcon B|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
228078|NCT01464255|E1|Reported Event|Ocufilcon D|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
228079|NCT01464229|B3|Baseline|Total|Total of all reporting groups
228080|NCT01464229|B2|Baseline|Placebo, Then Iloperidone|Placebo: Placebo for 4 weeks then iloperidone for 4 weeks; addition to standard SSRI antidepressant
228083|NCT01464229|P1|Participant Flow|Iloperidone, Then Placebo|Iloperidone (1-8 mg) for 4 weeks, then placebo for 4 weeks; in addition to standard SSRI antidepressant
228084|NCT01464229|O2|Outcome|Placebo, Then Iloperidone|Placebo: Placebo for 4 weeks then iloperidone for 4 weeks; addition to standard SSRI antidepressant
228085|NCT01464229|O1|Outcome|Iloperidone, Then Placebo|Iloperidone: Iloperidone 1-8 mg for 4 weeks then placebo for 4 weeks; addition to SSRI antidepressant
228086|NCT01464229|E2|Reported Event|Placebo|
228087|NCT01464229|E1|Reported Event|Iloperidone|
228088|NCT01464190|B3|Baseline|Total|Total of all reporting groups
228089|NCT01464190|B2|Baseline|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
228090|NCT01464190|B1|Baseline|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
228091|NCT01464190|P2|Participant Flow|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
228092|NCT01464190|P1|Participant Flow|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day)
228093|NCT01464190|O2|Outcome|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
228094|NCT01464190|O1|Outcome|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
228095|NCT01464190|O2|Outcome|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
228096|NCT01464190|O1|Outcome|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
228097|NCT01464190|O2|Outcome|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
228098|NCT01464190|O1|Outcome|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
228099|NCT01464190|E2|Reported Event|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
228100|NCT01464190|E1|Reported Event|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
228101|NCT01464021|B1|Baseline|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
228102|NCT01464021|P1|Participant Flow|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
228103|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
228104|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
228105|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
228106|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
228107|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
228108|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
228109|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
228110|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
228111|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
228112|NCT01464021|E1|Reported Event|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
228113|NCT01463982|B5|Baseline|Total|Total of all reporting groups
228114|NCT01463982|B4|Baseline|Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
228115|NCT01463982|B3|Baseline|Capecitabine 800mg/㎡ + Oratecan 20mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
228116|NCT01463982|B2|Baseline|Capecitabine 800mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
228117|NCT01463982|B1|Baseline|Capecitabine 800mg/㎡ + Oratecan 10mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
229027|NCT01461369|O1|Outcome|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
228118|NCT01463982|P4|Participant Flow|Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
228119|NCT01463982|P3|Participant Flow|Capecitabine 800mg/㎡ + Oratecan 20mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
228120|NCT01463982|P2|Participant Flow|Capecitabine 800mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
228121|NCT01463982|P1|Participant Flow|Capecitabine 800mg/㎡ + Oratecan 10mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
228122|NCT01463982|O4|Outcome|Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
228123|NCT01463982|O3|Outcome|Capecitabine 800mg/㎡ + Oratecan 20mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
228124|NCT01463982|O2|Outcome|Capecitabine 800mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
228125|NCT01463982|O1|Outcome|Capecitabine 800mg/㎡ + Oratecan 10mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
228126|NCT01463982|O4|Outcome|Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
228127|NCT01463982|O3|Outcome|Capecitabine 800mg/㎡ + Oratecan 20mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
228128|NCT01463982|O2|Outcome|Capecitabine 800mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
228129|NCT01463982|O1|Outcome|Capecitabine 800mg/㎡ + Oratecan 10mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
228130|NCT01463982|E4|Reported Event|Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
228131|NCT01463982|E3|Reported Event|Capecitabine 800mg/㎡ + Oratecan 20mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
228132|NCT01463982|E2|Reported Event|Capecitabine 800mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
228133|NCT01463982|E1|Reported Event|Capecitabine 800mg/㎡ + Oratecan 10mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
228134|NCT01463878|B3|Baseline|Total|Total of all reporting groups
228135|NCT01463878|B2|Baseline|Control - Jevity|The control arm of the study. Patients to receive Jevity
228136|NCT01463878|B1|Baseline|Glycerna|Diabetic specific formula
228137|NCT01463878|P2|Participant Flow|Control - Jevity|The control arm of the study. Patients to receive Jevity
228138|NCT01463878|P1|Participant Flow|Glycerna|Diabetic specific formula
228139|NCT01463878|O2|Outcome|Control - Jevity|The control arm of the study. Patients to receive Jevity
228140|NCT01463878|O1|Outcome|Glycerna|Diabetic specific formula
228141|NCT01463878|E2|Reported Event|Control - Jevity|The control arm of the study. Patients to receive Jevity
228142|NCT01463878|E1|Reported Event|Glycerna|Diabetic specific formula
228143|NCT01463696|B9|Baseline|Total|Total of all reporting groups
228144|NCT01463696|B8|Baseline|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
228145|NCT01463696|B7|Baseline|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
228146|NCT01463696|B6|Baseline|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
228147|NCT01463696|B5|Baseline|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
228148|NCT01463696|B4|Baseline|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
228149|NCT01463696|B3|Baseline|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
228150|NCT01463696|B2|Baseline|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
228151|NCT01463696|B1|Baseline|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
228152|NCT01463696|P8|Participant Flow|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
228153|NCT01463696|P7|Participant Flow|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
228154|NCT01463696|P6|Participant Flow|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
228155|NCT01463696|P5|Participant Flow|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
228156|NCT01463696|P4|Participant Flow|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
228157|NCT01463696|P3|Participant Flow|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
228158|NCT01463696|P2|Participant Flow|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
228159|NCT01463696|P1|Participant Flow|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered orally (PO) twice a day (BID) on Days 1-6 and PO once daily (QD) in the morning on Day 7 of the 21-day cycle to accommodate pharmacokinetic (PK) sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
228160|NCT01463696|O8|Outcome|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
228161|NCT01463696|O7|Outcome|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
228162|NCT01463696|O6|Outcome|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
228163|NCT01463696|O5|Outcome|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
228164|NCT01463696|O4|Outcome|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
228165|NCT01463696|O3|Outcome|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
228166|NCT01463696|O2|Outcome|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
228167|NCT01463696|O1|Outcome|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
228168|NCT01463696|O8|Outcome|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
228169|NCT01463696|O7|Outcome|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
228170|NCT01463696|O6|Outcome|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
228225|NCT01463683|E1|Reported Event|V232-2XP SC|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
228171|NCT01463696|O5|Outcome|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
228172|NCT01463696|O4|Outcome|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
228173|NCT01463696|O3|Outcome|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
228174|NCT01463696|O2|Outcome|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
228175|NCT01463696|O1|Outcome|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
228176|NCT01463696|O8|Outcome|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
228177|NCT01463696|O7|Outcome|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
228178|NCT01463696|O6|Outcome|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
228179|NCT01463696|O5|Outcome|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
228180|NCT01463696|O4|Outcome|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
228181|NCT01463696|O3|Outcome|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
228182|NCT01463696|O2|Outcome|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
228183|NCT01463696|O1|Outcome|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
228184|NCT01463696|O8|Outcome|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
228185|NCT01463696|O7|Outcome|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
228186|NCT01463696|O6|Outcome|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
228187|NCT01463696|O5|Outcome|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
228188|NCT01463696|O4|Outcome|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
228189|NCT01463696|O3|Outcome|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
228190|NCT01463696|O2|Outcome|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
228191|NCT01463696|O1|Outcome|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
228192|NCT01463696|O8|Outcome|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
228226|NCT01463527|B3|Baseline|Total|Total of all reporting groups
228227|NCT01463527|B2|Baseline|Capnography Blind|Staff members were blinded to screen on capnography monitor and all alarms turned off for the sedation.
228193|NCT01463696|O7|Outcome|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
228194|NCT01463696|O6|Outcome|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
228195|NCT01463696|O5|Outcome|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
228196|NCT01463696|O4|Outcome|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
228197|NCT01463696|O3|Outcome|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
228198|NCT01463696|O2|Outcome|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
228199|NCT01463696|O1|Outcome|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
228200|NCT01463696|E8|Reported Event|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
228201|NCT01463696|E7|Reported Event|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
228202|NCT01463696|E6|Reported Event|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
228203|NCT01463696|E5|Reported Event|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
228204|NCT01463696|E4|Reported Event|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
228205|NCT01463696|E3|Reported Event|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
228206|NCT01463696|E2|Reported Event|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
228207|NCT01463696|E1|Reported Event|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
228208|NCT01463683|B4|Baseline|Total|Total of all reporting groups
228209|NCT01463683|B3|Baseline|V232-2XP IM|2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
228210|NCT01463683|B2|Baseline|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
228211|NCT01463683|B1|Baseline|V232-2XP SC|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
228212|NCT01463683|P3|Participant Flow|V232-2XP Intramuscular (IM)|2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
228213|NCT01463683|P2|Participant Flow|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
228214|NCT01463683|P1|Participant Flow|V232-2XP Subcutaneous (SC)|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
228215|NCT01463683|O3|Outcome|V232-2XP IM|2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
228216|NCT01463683|O2|Outcome|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
228217|NCT01463683|O1|Outcome|V232-2XP SC|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
228218|NCT01463683|O3|Outcome|V232-2XP IM|2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
228219|NCT01463683|O2|Outcome|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
228220|NCT01463683|O1|Outcome|V232-2XP SC|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
228221|NCT01463683|O2|Outcome|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
228222|NCT01463683|O1|Outcome|V232-2XP SC|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
228223|NCT01463683|E3|Reported Event|V232-2XP IM|2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
228224|NCT01463683|E2|Reported Event|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
228228|NCT01463527|B1|Baseline|Open Capnography|Staff members able to view capnography monitor during sedation.
228229|NCT01463527|P2|Participant Flow|Capnography Blind|Staff members blinded to capnography screen and alarms turned off during sedation.
228230|NCT01463527|P1|Participant Flow|Open Capnography|Staff members able to view capnography monitor during sedation.
228231|NCT01463527|O2|Outcome|Capnography Blind|Staff blinded to capnography screen and alarms turned off during sedation.
228232|NCT01463527|O1|Outcome|Open Capnography|Staff able to view capnography monitor during sedation.
228233|NCT01463527|O2|Outcome|Capnography Blind|Staff blinded to capnography screen and alarms turned off during sedation.
228234|NCT01463527|O1|Outcome|Open Capnography|Staff able to view capnography monitor during sedation.
228235|NCT01463527|E2|Reported Event|Capnography Blind|Nellcor NPB-70 Capnograph: Use of capnography as an additional monitor during sedation to detect hypoventilation and apnea prior to declines in pulse oximetry and clinical examination findings
228236|NCT01463527|E1|Reported Event|Open Capnography|Nellcor NPB-70 Capnograph: Use of capnography as an additional monitor during sedation to detect hypoventilation and apnea prior to declines in pulse oximetry and clinical examination findings
228237|NCT01463384|B1|Baseline|Minocycline|Subjects administered 50mg minocycline twice daily for 6 months
228238|NCT01463384|P1|Participant Flow|Minocycline|Subjects were administered 50mg minocycline twice daily for 6 months
228239|NCT01463384|O3|Outcome|Minocycline NC|Normal control subjects who were administered 50mg minocycline twice daily.
228240|NCT01463384|O2|Outcome|Minocycline MCI|Mild cognitively impaired subject who was administered 50mg minocycline twice daily.
228241|NCT01463384|O1|Outcome|Minocycline AD|Alzheimer subjects who were administered 50mg minocycline twice daily.
228242|NCT01463384|O3|Outcome|Minocycline NC|Normal control subjects who were administered 50mg minocycline twice daily.
228243|NCT01463384|O2|Outcome|Minocycline MCI|Mild cognitively impaired subject who was administered 50mg minocycline twice daily.
228244|NCT01463384|O1|Outcome|Minocycline AD|Alzheimer subjects who were administered 50mg minocycline twice daily.
228245|NCT01463384|O3|Outcome|Minocycline NC|Normal control subjects who were administered 50mg minocycline twice daily.
228246|NCT01463384|O2|Outcome|Minocycline MCI|Mild cognitively impaired subject who was administered 50mg minocycline twice daily.
228247|NCT01463384|O1|Outcome|Minocycline AD|Alzheimer subjects who were administered 50mg minocycline twice daily.
228248|NCT01463384|E1|Reported Event|Minocycline|No adverse events were reported in any subjects who were taking minocycline. All subjects underwent monthly blood tests to monitor alanine transaminase and blood urea nitrogen levels.
228249|NCT01463293|B4|Baseline|Total|Total of all reporting groups
228250|NCT01463293|B3|Baseline|Placebo|"Placebo capsule~Placebo: Capsule containing no probiotic once a day"
228251|NCT01463293|B2|Baseline|Low Dose Probiotic|"Capsule containing 1 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day"
228252|NCT01463293|B1|Baseline|High-dose Probiotic|"Capsule containing 10 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day"
228253|NCT01463293|P3|Participant Flow|Placebo|"Placebo capsule~Placebo: Capsule containing no probiotic once a day"
228254|NCT01463293|P2|Participant Flow|Low Dose Probiotic|"Capsule containing 1 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day"
228255|NCT01463293|P1|Participant Flow|High-dose Probiotic|"Capsule containing 10 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day"
228256|NCT01463293|O3|Outcome|Placebo|"Placebo capsule~Placebo: Capsule containing no probiotic once a day"
228257|NCT01463293|O2|Outcome|Low Dose Probiotic|"Capsule containing 1 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day"
228258|NCT01463293|O1|Outcome|High-dose Probiotic|"Capsule containing 10 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day"
228259|NCT01463293|E3|Reported Event|Placebo|"Placebo capsule~Placebo: Capsule containing no probiotic once a day"
228260|NCT01463293|E2|Reported Event|Low Dose Probiotic|"Capsule containing 1 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day"
228261|NCT01463293|E1|Reported Event|High-dose Probiotic|"Capsule containing 10 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day"
228262|NCT01463202|B3|Baseline|Total|Total of all reporting groups
228263|NCT01463202|B2|Baseline|DMPA at 4-6 Weeks After Delivery|"Depot medroxyprogesterone acetate at 4-6 weeks after delivery~Depot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)"
228264|NCT01463202|B1|Baseline|DMPA Postpartum|"Depot medroxyprogesterone acetate postpartum~Depot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)"
228265|NCT01463202|P2|Participant Flow|DMPA at 4-6 Weeks After Delivery|"Depot medroxyprogesterone acetate at 4-6 weeks after delivery~Depot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)"
228266|NCT01463202|P1|Participant Flow|DMPA Postpartum|"Depot medroxyprogesterone acetate postpartum~Depot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)"
228267|NCT01463202|O2|Outcome|DMPA at 4-6 Weeks After Delivery|"Depot medroxyprogesterone acetate at 4-6 weeks after delivery~Depot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)"
228268|NCT01463202|O1|Outcome|DMPA Postpartum|"Depot medroxyprogesterone acetate postpartum~Depot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)"
228269|NCT01463202|O2|Outcome|DMPA at 4-6 Weeks After Delivery|"Depot medroxyprogesterone acetate at 4-6 weeks after delivery~Depot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)"
228270|NCT01463202|O1|Outcome|DMPA Postpartum|"Depot medroxyprogesterone acetate postpartum~Depot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)"
228271|NCT01463202|E2|Reported Event|DMPA at 4-6 Weeks After Delivery|"Depot medroxyprogesterone acetate at 4-6 weeks after delivery~Depot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)"
229028|NCT01461369|E3|Reported Event|Placebo|Placebo: Capsule
228272|NCT01463202|E1|Reported Event|DMPA Postpartum|"Depot medroxyprogesterone acetate postpartum~Depot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)"
228273|NCT01463111|B1|Baseline|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.~Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
228274|NCT01463111|P1|Participant Flow|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.~Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
228275|NCT01463111|O1|Outcome|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.~Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
228276|NCT01463111|O1|Outcome|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.~Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
228277|NCT01463111|O1|Outcome|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.~Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
228278|NCT01463111|O1|Outcome|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.~Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
228279|NCT01463111|O1|Outcome|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.~Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
228280|NCT01463111|E1|Reported Event|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.~Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
228281|NCT01463033|B3|Baseline|Total|Total of all reporting groups
228282|NCT01463033|B2|Baseline|Observational|60 subjects with acute head injury with a high risk for developing post-traumatic epilepsy enrolled 8-24 hours after injury will not receive levetiracetam. Subjects will receive phenytoin for 1 week following head injury as standard clinical care.
228283|NCT01463033|B1|Baseline|Levetiracetam|66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy will receive levetiracetam 55 mg/kg/day in a b.i.d. schedule. Treatment will commence within 8 hours of the acute head injury and will last for 30 days. In addition, subjects will receive phenytoin for 1 week following head injury as standard clinical care.
228284|NCT01463033|P2|Participant Flow|Observational|60 subjects with acute head injury with a high risk for developing post-traumatic epilepsy enrolled 8-24 hours after injury will not receive levetiracetam. Subjects will receive phenytoin for 1 week following head injury as standard clinical care.
228285|NCT01463033|P1|Participant Flow|Levetiracetam|66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy will receive levetiracetam 55 mg/kg/day in a b.i.d. schedule. Treatment will commence within 8 hours of the acute head injury and will last for 30 days. In addition, subjects will receive phenytoin for 1 week following head injury as standard clinical care.
228286|NCT01463033|O1|Outcome|Participants|The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. schedule were monitored for adverse events through the 30 day treatment period.
228287|NCT01463033|O2|Outcome|Observational|60 subjects with acute head injury with a high risk for developing post-traumatic epilepsy enrolled 8-24 hours after injury will not receive levetiracetam. Subjects will receive phenytoin for 1 week following head injury as standard clinical care.
228288|NCT01463033|O1|Outcome|Levetiracetam|66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy will receive levetiracetam 55 mg/kg/day in a b.i.d. schedule. Treatment will commence within 8 hours of the acute head injury and will last for 30 days. In addition, subjects will receive phenytoin for 1 week following head injury as standard clinical care.
228289|NCT01463033|E2|Reported Event|Observational|Adverse events were not monitored for the Observational group
228290|NCT01463033|E1|Reported Event|Levetiracetam|The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.
228291|NCT01463007|B1|Baseline|Radiation|"AccuBoost APBI- 34.0 Gy in 10fx~Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions"
228292|NCT01463007|P1|Participant Flow|Radiation|"AccuBoost APBI- 34.0 Gy in 10fx~Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions"
228293|NCT01463007|O1|Outcome|Radiation|"AccuBoost APBI- 34.0 Gy in 10fx~Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions"
228294|NCT01463007|O2|Outcome|Extended to 5 Years of Follow Up-Rhode Island Hospital Only|Follow up has been extended to include follow up visits at 2,6 weeks and at 4,6,12,18,24 months then annually (+/- 6 months) for an additional 3 years for a total of approximately 5 years of follow up.
228295|NCT01463007|O1|Outcome|Radiation|"AccuBoost APBI- 34.0 Gy in 10fx~Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions"
228296|NCT01463007|E1|Reported Event|Radiation|"AccuBoost APBI- 34.0 Gy in 10fx~Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions"
228297|NCT01462942|B6|Baseline|Total|Total of all reporting groups
228298|NCT01462942|B5|Baseline|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228299|NCT01462942|B4|Baseline|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228300|NCT01462942|B3|Baseline|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228301|NCT01462942|B2|Baseline|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228302|NCT01462942|B1|Baseline|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228303|NCT01462942|P5|Participant Flow|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228304|NCT01462942|P4|Participant Flow|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228305|NCT01462942|P3|Participant Flow|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228306|NCT01462942|P2|Participant Flow|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228307|NCT01462942|P1|Participant Flow|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228308|NCT01462942|O5|Outcome|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228309|NCT01462942|O4|Outcome|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228310|NCT01462942|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228311|NCT01462942|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228312|NCT01462942|O1|Outcome|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228313|NCT01462942|O5|Outcome|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228314|NCT01462942|O4|Outcome|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228315|NCT01462942|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228316|NCT01462942|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228317|NCT01462942|O1|Outcome|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228318|NCT01462942|O5|Outcome|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228319|NCT01462942|O4|Outcome|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228320|NCT01462942|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228321|NCT01462942|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228322|NCT01462942|O1|Outcome|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228323|NCT01462942|O5|Outcome|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228324|NCT01462942|O4|Outcome|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228325|NCT01462942|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228326|NCT01462942|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228327|NCT01462942|O1|Outcome|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
228328|NCT01462942|E5|Reported Event|Formoterol 12 μg|
228329|NCT01462942|E4|Reported Event|Aclidinium 400 μg|
228330|NCT01462942|E3|Reported Event|Aclidinium/Formoterol 400/6 μg|
228331|NCT01462942|E2|Reported Event|Aclidinium/Formoterol 400/12 μg|
228332|NCT01462942|E1|Reported Event|Placebo|
228333|NCT01462929|B4|Baseline|Total|Total of all reporting groups
228334|NCT01462929|B3|Baseline|Placebo|"Placebo~Route of administration:~Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h)."
228335|NCT01462929|B2|Baseline|Tiotropium 18 μg Once-daily|"Tiotropium 18 μg administered once daily~Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler.~Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)~AND~1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler."
228336|NCT01462929|B1|Baseline|Aclidinium Bromide 400 µg BID|"Aclidinium bromide 400 µg administered twice per day~Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler.~Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)~AND~1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler."
228337|NCT01462929|P3|Participant Flow|Placebo|"Placebo~Route of administration:~Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h)."
228338|NCT01462929|P2|Participant Flow|Tiotropium 18 μg Once-daily|"Tiotropium 18 μg administered once daily~Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler.~Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)~AND~1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler."
228339|NCT01462929|P1|Participant Flow|Aclidinium Bromide 400 µg BID|"Aclidinium bromide 400 µg administered twice per day~Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler.~Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)~AND~1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler."
228340|NCT01462929|O3|Outcome|Placebo|"Placebo~Route of administration:~Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h)."
228341|NCT01462929|O2|Outcome|Tiotropium 18 μg Once-daily|"Tiotropium 18 μg administered once daily~Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler.~Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)~AND~1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler."
228342|NCT01462929|O1|Outcome|Aclidinium Bromide 400 µg BID|"Aclidinium bromide 400 µg administered twice per day~Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler.~Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)~AND~1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler."
228343|NCT01462929|O3|Outcome|Placebo|"Placebo~Route of administration:~Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h)."
228344|NCT01462929|O2|Outcome|Tiotropium 18 μg Once-daily|"Tiotropium 18 μg administered once daily~Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler.~Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)~AND~1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler."
228345|NCT01462929|O1|Outcome|Aclidinium Bromide 400 µg BID|"Aclidinium bromide 400 µg administered twice per day~Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler.~Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)~AND~1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler."
228346|NCT01462929|E3|Reported Event|Placebo|"Placebo~Route of administration:~Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h)."
228347|NCT01462929|E2|Reported Event|Tiotropium 18 μg Once-daily|"Tiotropium 18 μg administered once daily~Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler.~Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)~AND~1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler."
228348|NCT01462929|E1|Reported Event|Aclidinium Bromide 400 µg BID|"Aclidinium bromide 400 µg administered twice per day~Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler.~Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)~AND~1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler."
228349|NCT01462877|B1|Baseline|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
228350|NCT01462877|P1|Participant Flow|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
228351|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
228352|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
228353|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
228354|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
228355|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
228356|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
228357|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
228358|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
228359|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
228360|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
228361|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
228362|NCT01462877|E1|Reported Event|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
228363|NCT01462812|B3|Baseline|Total|Total of all reporting groups
228364|NCT01462812|B2|Baseline|Sumatriptan|Sumatriptan : Sumatriptan 20mg
228365|NCT01462812|B1|Baseline|Matching Placebo|Placebo : Matching placebo
228366|NCT01462812|P2|Participant Flow|Sumatriptan|Sumatriptan : Sumatriptan 20mg
228367|NCT01462812|P1|Participant Flow|Matching Placebo|Placebo : Matching placebo
228368|NCT01462812|O2|Outcome|Sumatriptan|Sumatriptan : Sumatriptan 20mg
228369|NCT01462812|O1|Outcome|Matching Placebo|Placebo : Matching placebo
228370|NCT01462812|E2|Reported Event|Sumatriptan|Sumatriptan : Sumatriptan 20mg
228371|NCT01462812|E1|Reported Event|Matching Placebo|Placebo : Matching placebo
228372|NCT01462773|B1|Baseline|Treatment (Enzyme Inhibitor, Interferon Therapy)|Patients receive bortezomib IV over 3-5 seconds on days 1, 8, 15, and 22 and recombinant interferon alfa-2b SC on days 1, 3, and 5 (days 1 and 3 only in week 4 course 1) of weeks 1-4. Treatment repeats every 5 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.
228373|NCT01462773|P1|Participant Flow|Bortezomib & Interferon-a|Bortezomib was administered intravenously weekly along with IFN-a thrice weekly.
228374|NCT01462773|O1|Outcome|Bortezomib & Interferon-a|Bortezomib was administered intravenously weekly along with IFN-a thrice weekly.
228375|NCT01462773|O1|Outcome|Bortezomib & Interferon-a|Patients were treated on a 5-week cycle. Week 1 of cycle 1, patients received 5 million U/m(2) IFN-a subcutaneously thrice weekly. Weeks 2-4 of cycle 1, bortezomib was administered intravenously weely along with IFN-a thrice weekly. A break from treatment during week 5. Folllowing cycle 1, bortezomib was administered in combination iwth IFN-a. Bortezomib was administered in escalating doses to cohorts of 3 patients.
228465|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
228376|NCT01462773|E1|Reported Event|Treatment (Enzyme Inhibitor, Interferon Therapy)|Patients were treated on a 5-week cycle. In week 1 of cycle 1, patients received 5 million U/m(2) IFN-α subcutaneously thrice weekly. During weeks 2-4 of cycle 1, bortezomib was administered intravenously weekly along with IFN-α thrice weekly. There was a treatment break during week 5. After cycle 1, bortezomib was administered in combination with IFN-α. Bortezomib was administered in escalating doses (1.0, 1.3, or 1.6 mg/m) to cohorts of 3 patients.
228377|NCT01462695|B3|Baseline|Total|Total of all reporting groups
228378|NCT01462695|B2|Baseline|Stratum B: Recurrent Ependymoma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
228379|NCT01462695|B1|Baseline|Stratum A: Recurrent High Grade Glioma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
228380|NCT01462695|P2|Participant Flow|Stratum B: Recurrent Ependymoma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
228381|NCT01462695|P1|Participant Flow|Stratum A: Recurrent High Grade Glioma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
228382|NCT01462695|O2|Outcome|Stratum B: Recurrent Ependymoma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
228383|NCT01462695|O1|Outcome|Stratum A: Recurrent High Grade Glioma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
228384|NCT01462695|E2|Reported Event|Stratum B: Recurrent Ependymoma|Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
228385|NCT01462695|E1|Reported Event|Stratum A: Recurrent High Grade Glioma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
228386|NCT01462565|B1|Baseline|Epoprostenol Sodium for Injection|Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
228387|NCT01462565|P1|Participant Flow|Epoprostenol Sodium for Injection|Participants received new thermo stable 100 milliliter (mL) formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
228388|NCT01462565|O1|Outcome|Epoprostenol Sodium for Injection|Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
228389|NCT01462565|O1|Outcome|Epoprostenol Sodium for Injection|Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
228390|NCT01462565|O1|Outcome|Epoprostenol Sodium for Injection|Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
228391|NCT01462565|O1|Outcome|Epoprostenol Sodium for Injection|Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
228392|NCT01462565|O1|Outcome|Epoprostenol Sodium for Injection|Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
228393|NCT01462565|O1|Outcome|Epoprostenol Sodium for Injection|Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
228394|NCT01462565|O1|Outcome|Epoprostenol Sodium for Injection|Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
228395|NCT01462565|O1|Outcome|Epoprostenol Sodium for Injection|Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
228396|NCT01462565|O1|Outcome|Epoprostenol Sodium for Injection|Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
228397|NCT01462565|O1|Outcome|Epoprostenol Sodium for Injection|Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
228398|NCT01462565|O1|Outcome|Epoprostenol Sodium for Injection|Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
228399|NCT01462565|O1|Outcome|Epoprostenol Sodium for Injection|Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
228400|NCT01462565|O1|Outcome|Epoprostenol Sodium for Injection|Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
228401|NCT01462565|O1|Outcome|Epoprostenol Sodium for Injection|Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
228402|NCT01462565|O1|Outcome|Epoprostenol Sodium for Injection|Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
228403|NCT01462565|E1|Reported Event|Epoprostenol Sodium for Injection|Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
228404|NCT01462435|B5|Baseline|Total|Total of all reporting groups
228405|NCT01462435|B4|Baseline|Placebo|Placebo : Capsules
228406|NCT01462435|B3|Baseline|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
228407|NCT01462435|B2|Baseline|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
228408|NCT01462435|B1|Baseline|Celecoxib|Celecoxib : 200 mg Capsules
228409|NCT01462435|P4|Participant Flow|Placebo|Placebo : Capsules
228410|NCT01462435|P3|Participant Flow|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
228411|NCT01462435|P2|Participant Flow|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
228412|NCT01462435|P1|Participant Flow|Celecoxib|Celecoxib : 200 mg Capsules
228413|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
228414|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
228415|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
228416|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
228417|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
228418|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
228419|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
228420|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
228421|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
228422|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
228423|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
228424|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
228425|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
228426|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
228427|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
228428|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
228429|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
228430|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
228431|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
228432|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
228433|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
228434|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
228435|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
228436|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
228437|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
228438|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
228439|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
228440|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
228441|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
228442|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
228443|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
228444|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
228445|NCT01462435|E4|Reported Event|Placebo|Placebo : Capsules
228446|NCT01462435|E3|Reported Event|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
228447|NCT01462435|E2|Reported Event|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
228448|NCT01462435|E1|Reported Event|Celecoxib|Celecoxib : 200 mg Capsules
228449|NCT01462370|B1|Baseline|All Randomized Participants|All participants randomized into the study.
228450|NCT01462370|P2|Participant Flow|Ibuprofen Up to 2400 mg / Etoricoxib 120 mg|Ibuprofen 600 mg given orally up to for times a day as needed for a maximum of 2400 mg/day in menstrual cyle 1. In menstrual cycle 2, etoricoxib 120 mg ws given orally for one dose.
228451|NCT01462370|P1|Participant Flow|Etoricoxib 120 mg/ Ibuprofen Up to 2400 mg|Etoricoxib 120 mg tablet given orally or one dose in menstrual cycle 1. In menstrual cycle 2, ibuprofen was administered at a dose of 600 mg every 4 hours as needed up to 2400 mg/day.
228452|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
228453|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
228454|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
228455|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
228456|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
228457|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
228458|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
228459|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
228460|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
228461|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
228462|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
228463|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
228464|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
228466|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
228467|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
228468|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
228469|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
228470|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
228471|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
228472|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
228473|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
228474|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
228475|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
228476|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
228477|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
228478|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
228479|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
228480|NCT01462370|E2|Reported Event|Ibuprofen up to 2400 mg / Etoricoxib 120 mg|Ibuprofen 600 mg given orally up to four times a day as needed, for a maximum of 2400 mg/day in menstrual cycle 1. In menstrual cycle 2, etoricoxib was administered at a dose of 120 mg daily.
228481|NCT01462370|E1|Reported Event|Etoricoxib 120 mg / Ibuprofen up to 2400 mg/Daily|Etoricoxib 120 mg tablet given orally for one dose in menstrual cycle 1. In menstrual cycle 2, ibuprofen was administered at a dose of 600 mg every 4 hours as needed up to 2400 mg/day.
228482|NCT01462357|B4|Baseline|Total|Total of all reporting groups
228483|NCT01462357|B3|Baseline|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228484|NCT01462357|B2|Baseline|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228485|NCT01462357|B1|Baseline|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228486|NCT01462357|P3|Participant Flow|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228487|NCT01462357|P2|Participant Flow|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228488|NCT01462357|P1|Participant Flow|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228489|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228490|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228491|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228492|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228493|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228494|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228495|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228496|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228497|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228498|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228499|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228689|NCT01462227|B2|Baseline|Naltrexone (Higher Dose)|Naltrexone: Naltrexone 100mg, 1 tablet given every 12 hours orally
261439|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
228500|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228501|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228502|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228503|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228504|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228505|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228506|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228507|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228508|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228509|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228510|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228511|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228512|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228513|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228514|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228515|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228516|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228517|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228518|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228519|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228520|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228521|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228522|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228523|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228524|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228525|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228526|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228527|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228690|NCT01462227|B1|Baseline|Naltrexone (Lower Dose)|Naltrexone: Naltrexone 50 mg, 1 tablet given every 12 hours orally
228528|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228529|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228530|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228531|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228532|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228533|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228534|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228535|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228536|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228537|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228538|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228539|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228540|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228541|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228542|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228543|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228544|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228545|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228546|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228547|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228548|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228549|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228550|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228551|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228552|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228553|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228554|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228555|NCT01462357|E3|Reported Event|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228785|NCT01461993|E3|Reported Event|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
228556|NCT01462357|E2|Reported Event|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228557|NCT01462357|E1|Reported Event|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
228558|NCT01462344|B3|Baseline|Total|Total of all reporting groups
228559|NCT01462344|B2|Baseline|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
228560|NCT01462344|B1|Baseline|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
228561|NCT01462344|P2|Participant Flow|Fluticasone Propionate (FP)|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
228562|NCT01462344|P1|Participant Flow|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
228563|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
228564|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
228565|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
228566|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
228567|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
228568|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
228569|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
228691|NCT01462227|P4|Participant Flow|Placebo First / Naltrexone (Higher Dose) Second|Placebo given 12 hours prior to visit orally Naltrexone 100 mg (1 tablet) given at time of visit orally
228570|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
228571|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
228572|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
228573|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
228574|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
228575|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
228576|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
228577|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
228578|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
228579|NCT01462344|E2|Reported Event|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
228580|NCT01462344|E1|Reported Event|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
228581|NCT01462318|B3|Baseline|Total|Total of all reporting groups
228582|NCT01462318|B2|Baseline|TP-DI Sub-study|"In Period 1 (Week -1), the probe-drug cocktail (consisting of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg, where the oral vitamin K was used prophylactically to counteract warfarin’s anticoagulant effect) was administered 7 days before the first dose of DAC HYP 150 mg in the 3-year extension phase.~In Period 2, pretreatment with DAC HYP 150 mg was administered at Weeks 0, 4, and 8. The probe-drug cocktail was administered 7 days after the third dose of DAC HYP."
228692|NCT01462227|P3|Participant Flow|Naltrexone (Higher Dose) First /Placebo Second|Naltrexone 100 mg, 1 tablet given 12 hours prior to visit orally Placebo given at time of visit orally
228583|NCT01462318|B1|Baseline|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.~Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
228584|NCT01462318|P3|Participant Flow|Extension Phase|After completion of the washout period from the Main Study or the TP-DI sub-study, eligible participants had the option to resume monthly open-label treatment with DAC HYP 150 mg in the extension phase of the study for up to 3 additional years.
228585|NCT01462318|P2|Participant Flow|Therapeutic Protein-Drug Interaction (TP-DI)Sub-study|"In Period 1 (Week -1), the probe-drug cocktail (consisting of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg, where the oral vitamin K was used prophylactically to counteract warfarin’s anticoagulant effect) was administered 7 days before the first dose of DAC HYP 150 mg in the 3-year extension phase.~In Period 2, pretreatment with DAC HYP 150 mg was administered at Weeks 0, 4, and 8. The probe-drug cocktail was administered 7 days after the third dose of DAC HYP."
228586|NCT01462318|P1|Participant Flow|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.~Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
228587|NCT01462318|O1|Outcome|TP-DI Sub-study|"In Period 1 (Week -1), the probe-drug cocktail (consisting of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg, where the oral vitamin K was used prophylactically to counteract warfarin’s anticoagulant effect) was administered 7 days before the first dose of DAC HYP 150 mg in the 3-year extension phase.~In Period 2, pretreatment with DAC HYP 150 mg was administered at Weeks 0, 4, and 8. The probe-drug cocktail was administered 7 days after the third dose of DAC HYP."
228588|NCT01462318|O1|Outcome|TP-DI Sub-study|"In Period 1 (Week -1), the probe-drug cocktail (consisting of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg, where the oral vitamin K was used prophylactically to counteract warfarin’s anticoagulant effect) was administered 7 days before the first dose of DAC HYP 150 mg in the 3-year extension phase.~In Period 2, pretreatment with DAC HYP 150 mg was administered at Weeks 0, 4, and 8. The probe-drug cocktail was administered 7 days after the third dose of DAC HYP."
228589|NCT01462318|O1|Outcome|TP-DI Sub-study|"In Period 1 (Week -1), the probe-drug cocktail (consisting of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg, where the oral vitamin K was used prophylactically to counteract warfarin’s anticoagulant effect) was administered 7 days before the first dose of DAC HYP 150 mg in the 3-year extension phase.~In Period 2, pretreatment with DAC HYP 150 mg was administered at Weeks 0, 4, and 8. The probe-drug cocktail was administered 7 days after the third dose of DAC HYP."
228590|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.~Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
228591|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.~Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
228592|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.~Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
228593|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.~Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
228594|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.~Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
228595|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.~Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
228596|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.~Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
228597|NCT01462318|O1|Outcome|TP-DI Sub-study|"In Period 1 (Week -1), the probe-drug cocktail (consisting of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg, where the oral vitamin K was used prophylactically to counteract warfarin’s anticoagulant effect) was administered 7 days before the first dose of DAC HYP 150 mg in the 3-year extension phase.~In Period 2, pretreatment with DAC HYP 150 mg was administered at Weeks 0, 4, and 8. The probe-drug cocktail was administered 7 days after the third dose of DAC HYP."
228693|NCT01462227|P2|Participant Flow|Placebo First/ Naltrexone (Lower Dose) Second|Placebo given given 12 hours prior to visit orally Naltrexone 50 mg (1 tablet) given at time of visit orally
228598|NCT01462318|O1|Outcome|TP-DI Sub-study|"In Period 1 (Week -1), the probe-drug cocktail (consisting of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg, where the oral vitamin K was used prophylactically to counteract warfarin’s anticoagulant effect) was administered 7 days before the first dose of DAC HYP 150 mg in the 3-year extension phase.~In Period 2, pretreatment with DAC HYP 150 mg was administered at Weeks 0, 4, and 8. The probe-drug cocktail was administered 7 days after the third dose of DAC HYP."
228599|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.~Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
228600|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.~Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
228601|NCT01462318|E1|Reported Event|DAC HYP 150 mg|DAC HYP 150 mg by SC injection using the PFS every 4 weeks for24 weeks followed by a 20-week washout period. After completion of the washout period, participants could resume monthly DAC HYP 150 mg using the PFS for up to 3 additional years. Participants in the TP-DI sub-study received s probe-drug cocktail administration at Weeks 43 and 53. The probe-drug cocktail consisted of midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg. The oral vitamin K was used to counteract warfarin’s anticoagulant effect prophylactically.
228602|NCT01462292|B4|Baseline|Total|Total of all reporting groups
228603|NCT01462292|B3|Baseline|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg/mL.
228604|NCT01462292|B2|Baseline|GSK2402968 3 mg/kg/Week|The participants in this arm were administered with 3 mg per kilogram kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg/mL.
228605|NCT01462292|B1|Baseline|Placebo (Combined)|The participants in this arm were administered matching placebo subcutaneously for 24 Weeks. It was provided as 3 mL vials containing 1 mL sterile solution.
228606|NCT01462292|P3|Participant Flow|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg/mL
228607|NCT01462292|P2|Participant Flow|GSK2402968 3 mg/kg/Week|The participants in this arm were administered with 3 milligram (mg) per kilogram (kg) GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg/mL
228608|NCT01462292|P1|Participant Flow|Placebo (Combined)|The participants in this arm were administered matching placebo subcutaneously for 24 Weeks. It was provided as 3 milliliter (mL) vials containing 1 mL sterile solution.
228609|NCT01462292|O3|Outcome|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
228610|NCT01462292|O2|Outcome|GSK2402968 3 mg/kg/Week|The participants in this arm were administered with 3 mg per kilogram kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
228611|NCT01462292|O1|Outcome|Placebo (Combined)|The participants in this arm were administered matching placebo subcutaneously for 24 Weeks. It was provided as 3 mL vials containing 1 mL sterile solution
228612|NCT01462292|O3|Outcome|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
228613|NCT01462292|O2|Outcome|GSK2402968 3 mg/kg/Week|The participants in this arm were administered with 3 mg per kilogram kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
228614|NCT01462292|O1|Outcome|Placebo (Combined)|The participants in this arm were administered matching placebo subcutaneously for 24 Weeks. It was provided as 3 mL vials containing 1 mL sterile solution
228615|NCT01462292|O3|Outcome|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
228616|NCT01462292|O2|Outcome|GSK2402968 3 mg/kg/Week|The participants in this arm were administered with 3 mg per kilogram kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
228617|NCT01462292|O1|Outcome|Placebo (Combined)|The participants in this arm were administered matching placebo subcutaneously for 24 Weeks. It was provided as 3 mL vials containing 1 mL sterile solution
228618|NCT01462292|O3|Outcome|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
228619|NCT01462292|O2|Outcome|GSK2402968 3 mg/kg/Week|The participants in this arm were administered with 3 mg per kilogram kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
228620|NCT01462292|O1|Outcome|Placebo (Combined)|The participants in this arm were administered matching placebo subcutaneously for 24 Weeks. It was provided as 3 mL vials containing 1 mL sterile solution
228621|NCT01462292|O3|Outcome|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
228786|NCT01461993|E2|Reported Event|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
228622|NCT01462292|O2|Outcome|GSK2402968 3 mg/kg/Week|The participants in this arm were administered with 3 mg per kilogram kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
228623|NCT01462292|O1|Outcome|Placebo (Combined)|The participants in this arm were administered matching placebo subcutaneously for 24 Weeks. It was provided as 3 mL vials containing 1 mL sterile solution
228624|NCT01462292|O3|Outcome|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
228625|NCT01462292|O2|Outcome|GSK2402968 3 mg/kg/Week|The participants in this arm were administered with 3 mg per kilogram kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
228626|NCT01462292|O1|Outcome|Placebo (Combined)|The participants in this arm were administered matching placebo subcutaneously for 24 Weeks. It was provided as 3 mL vials containing 1 mL sterile solution
228627|NCT01462292|O3|Outcome|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
228628|NCT01462292|O2|Outcome|GSK2402968 3 mg/kg/Week|The participants in this arm were administered with 3 mg per kilogram kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
228629|NCT01462292|O1|Outcome|Placebo (Combined)|The participants in this arm were administered matching placebo subcutaneously for 24 Weeks. It was provided as 3 mL vials containing 1 mL sterile solution
228630|NCT01462292|O3|Outcome|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
228631|NCT01462292|O2|Outcome|GSK2402968 3 mg/kg/Week|The participants in this arm were administered with 3 mg per kilogram kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
228632|NCT01462292|O1|Outcome|Placebo (Combined)|The participants in this arm were administered matching placebo subcutaneously for 24 Weeks. It was provided as 3 mL vials containing 1 mL sterile solution
228633|NCT01462292|O3|Outcome|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
228634|NCT01462292|O2|Outcome|GSK2402968 3 mg/kg/Week|The participants in this arm were administered with 3 mg per kilogram kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
228635|NCT01462292|O1|Outcome|Placebo (Combined)|The participants in this arm were administered matching placebo subcutaneously for 24 Weeks. It was provided as 3 mL vials containing 1 mL sterile solution
228636|NCT01462292|O3|Outcome|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
228637|NCT01462292|O2|Outcome|GSK2402968 3 mg/kg/Week|The participants in this arm were administered with 3 mg per kilogram kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
228638|NCT01462292|O1|Outcome|Placebo (Combined)|The participants in this arm were administered matching placebo subcutaneously for 24 Weeks. It was provided as 3 mL vials containing 1 mL sterile solution
228639|NCT01462292|O3|Outcome|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
228640|NCT01462292|O2|Outcome|GSK2402968 3 mg/kg/Week|The participants in this arm were administered with 3 mg per kilogram kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
228641|NCT01462292|O1|Outcome|Placebo (Combined)|The participants in this arm were administered matching placebo subcutaneously for 24 Weeks. It was provided as 3 mL vials containing 1 mL sterile solution
228642|NCT01462292|O3|Outcome|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
228643|NCT01462292|O2|Outcome|GSK2402968 3 mg/kg/Week|The participants in this arm were administered with 3 mg per kilogram kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
228644|NCT01462292|O1|Outcome|Placebo (Combined)|The participants in this arm were administered matching placebo subcutaneously for 24 Weeks. It was provided as 3 mL vials containing 1 mL sterile solution
228645|NCT01462292|O3|Outcome|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
228646|NCT01462292|O2|Outcome|GSK2402968 3 mg/kg/Week|The participants in this arm were administered with 3 mg per kilogram kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg per mL
228647|NCT01462292|O1|Outcome|Placebo (Combined)|The participants in this arm were administered matching placebo subcutaneously for 24 Weeks. It was provided as 3 mL vials containing 1 mL sterile solution
228648|NCT01462292|O3|Outcome|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg/mL
228694|NCT01462227|P1|Participant Flow|Naltrexone (Lower Dose) First /Placebo Second|Naltrexone 50 mg, 1 tablet given 12 hours prior to visit orally Placebo given at time of visit orally
228649|NCT01462292|O2|Outcome|GSK2402968 3 mg/kg/Week|The participants in this arm were administered with 3 mg per kilogram kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg/mL
228650|NCT01462292|O1|Outcome|Placebo (Combined)|The participants in this arm were administered matching placebo subcutaneously for 24 Weeks. It was provided as 3 mL vials containing 1 mL sterile solution
228651|NCT01462292|O3|Outcome|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg/mL
228652|NCT01462292|O2|Outcome|GSK2402968 3 mg/kg/Week|The participants in this arm were administered with 3 mg per kilogram kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg/mL
228653|NCT01462292|O1|Outcome|Placebo (Combined)|The participants in this arm were administered matching placebo subcutaneously for 24 Weeks. It was provided as 3 mL vials containing 1 mL sterile solution
228654|NCT01462292|O3|Outcome|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg/mL
228655|NCT01462292|O2|Outcome|GSK2402968 3 mg/kg/Week|The participants in this arm were administered with 3 mg per kilogram kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg/mL
228656|NCT01462292|O1|Outcome|Placebo (Combined)|The participants in this arm were administered matching placebo subcutaneously for 24 Weeks. It was provided as 3 mL vials containing 1 mL sterile solution
228657|NCT01462292|O3|Outcome|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg/mL
228658|NCT01462292|O2|Outcome|GSK2402968 3 mg/kg/Week|The participants in this arm were administered with 3 mg per kilogram kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg/mL
228659|NCT01462292|O1|Outcome|Placebo (Combined)|The participants in this arm were administered matching placebo subcutaneously for 24 Weeks. It was provided as 3 mL vials containing 1 mL sterile solution
228660|NCT01462292|O3|Outcome|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg/mL.
228661|NCT01462292|O2|Outcome|GSK2402968 3 mg/kg/Week|The participants in this arm were administered with 3 mg per kilogram kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg/mL
228662|NCT01462292|O1|Outcome|Placebo (Combined)|The participants in this arm were administered matching placebo subcutaneously for 24 Weeks. It was provided as 3 mL vials containing 1 mL sterile solution
228663|NCT01462292|E3|Reported Event|GSK2402968 6 mg/kg/Week|The participants in this arm were administered with 6 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg/mL
228664|NCT01462292|E2|Reported Event|GSK2402968 3 mg/kg/Week|The participants in this arm were administered with 3 mg per kg GSK2402968, subcutaneously for 24 weeks. It was provided as 3 mL vials containing 1 mL sterile solution. The concentration of drisapersen solution was 200 mg/mL
228665|NCT01462292|E1|Reported Event|Placebo (Combined)|The participants in this arm were administered matching placebo subcutaneously for 24 Weeks. It was provided as 3 mL vials containing 1 mL sterile solution
228666|NCT01462279|B1|Baseline|Thiamine|"Open label - 200mg IV~Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once"
228667|NCT01462279|P1|Participant Flow|Thiamine|"Open label - 200mg IV~Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once"
228668|NCT01462279|O1|Outcome|Thiamine|"Open label - 200mg IV~Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once"
228669|NCT01462279|O1|Outcome|Thiamine|"Open label - 200mg IV~Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once"
228670|NCT01462279|E1|Reported Event|Thiamine|"Open label - 200mg IV~Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once"
228671|NCT01462266|B3|Baseline|Total|Total of all reporting groups
228672|NCT01462266|B2|Baseline|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
228673|NCT01462266|B1|Baseline|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
228674|NCT01462266|P2|Participant Flow|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
228675|NCT01462266|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
228676|NCT01462266|O2|Outcome|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
228677|NCT01462266|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
228678|NCT01462266|O2|Outcome|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
228679|NCT01462266|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
228680|NCT01462266|O2|Outcome|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
228681|NCT01462266|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
228682|NCT01462266|O2|Outcome|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
228683|NCT01462266|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
228684|NCT01462266|O2|Outcome|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
228685|NCT01462266|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
228686|NCT01462266|E2|Reported Event|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
228687|NCT01462266|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
228688|NCT01462227|B3|Baseline|Total|Total of all reporting groups
228695|NCT01462227|O2|Outcome|Naltrexone (Higher Dose)|Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
228696|NCT01462227|O1|Outcome|Naltrexone (Lower Dose)|Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
228697|NCT01462227|O2|Outcome|Naltrexone (Higher Dose)|Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
228698|NCT01462227|O1|Outcome|Naltrexone (Lower Dose)|Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
228699|NCT01462227|O2|Outcome|Naltrexone (Higher Dose)|Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
228700|NCT01462227|O1|Outcome|Naltrexone (Lower Dose)|Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
228701|NCT01462227|O2|Outcome|Naltrexone (Higher Dose)|Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
228702|NCT01462227|O1|Outcome|Naltrexone (Lower Dose)|Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
228703|NCT01462227|O2|Outcome|Naltrexone (Higher Dose)|Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
228704|NCT01462227|O1|Outcome|Naltrexone (Lower Dose)|Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
228705|NCT01462227|O2|Outcome|Naltrexone (Higher Dose)|Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
228706|NCT01462227|O1|Outcome|Naltrexone (Lower Dose)|Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
228707|NCT01462227|E4|Reported Event|Placebo (Higher Dose)|Placebo 1 tablet given 12 hours and again at 1 hour prior to testing (orally).
228708|NCT01462227|E3|Reported Event|Naltrexone (100 mg)|Naltrexone 100 mg, 1 tablet given 12 hours and again at 1 hour prior to testing (orally).
228709|NCT01462227|E2|Reported Event|Placebo (Lower Dose Group)|Placebo 1 tablet given 12 hours and again at 1 hour prior to testing (orally).
228710|NCT01462227|E1|Reported Event|Naltrexone (50 mg)|Naltrexone 50 mg, 1 tablet given 12 hours and again at 1 hour prior to testing (orally).
228711|NCT01462162|B1|Baseline|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who had been considered and proposed by rheumatologist to start treatment with tocilizumab (RoActemra) according to the indications of the summary of product characteristics and the standard clinical practice of each participating center were followed-up for 6 months.
228712|NCT01462162|P1|Participant Flow|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who had been considered and proposed by rheumatologist to start treatment with tocilizumab (RoActemra) according to the indications of the summary of product characteristics and the standard clinical practice of each participating center were followed-up for 6 months.
228713|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
228714|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
228715|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
228716|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
228717|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
228718|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
228719|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
228720|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
228784|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
228721|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
228722|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
228723|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
228724|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
228725|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
228726|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
228727|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
228728|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
228729|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
228730|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
228731|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
228732|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
228733|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
228734|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who had been considered and proposed by rheumatologist to start treatment with tocilizumab (RoActemra) according to the indications of the summary of product characteristics and the standard clinical practice of each participating center were followed-up for 6 months.
228735|NCT01462162|E1|Reported Event|All Participants|Participants with moderate to severe RA who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
228736|NCT01462084|B1|Baseline|Overall Study Population|All study patients included in final analysis.
228737|NCT01462084|P2|Participant Flow|Bi-Level PAP|Bi-level PAP delivers two pressures, IPAP and EPAP. Both pressures are fixed and do not adjust based on the individuals breathing events. This is a crossover study, so patients in this arm used Bi-Level PAP therapy the first night and then crossed over and used ASV the second night.
228738|NCT01462084|P1|Participant Flow|Adaptive Servo-ventilation (ASV)|Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual. ASV adjusts to the breathing events the individual is experiencing and provides enough PAP to resolve the breathing event. This is a crossover study, so patients in this arm used ASV therapy the first night and then crossed over and used BiLevel PAP the second night.
228739|NCT01462084|O2|Outcome|Bi-Level PAP|Bi-level pressure delivers two pressures, IPAP and EPAP. Both pressures are fixed and do not adjust based on the individuals breathing events. This is a crossover study, so all patients enter both treatment groups.
231394|NCT01454583|B2|Baseline|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
228740|NCT01462084|O1|Outcome|Adaptive Servo-ventilation (ASV)|Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual. ASV adjusts to the breathing events the individual is experiencing and provides enough PAP to resolve the breathing event. Both pressures are fixed and do not adjust based on the individuals breathing events.
228741|NCT01462084|O2|Outcome|Bi-Level PAP|Bi-level pressure delivers two pressures, IPAP and EPAP. Both pressures are fixed and do not adjust based on the individuals breathing events. This is a crossover study, so all patients enter both treatment groups.
228742|NCT01462084|O1|Outcome|Adaptive Servo-Ventilation (ASV)|All patients received 1 night of therapy using Adaptive servo-ventilation (ASV) and 1 night of therapy using Bi-level PAP. Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual. ASV adjusts to the breathing events the individual is experiencing and provides enough PAP to resolve the breathing event. This is a crossover study, so all patients enter both treatment groups.
228743|NCT01462084|E2|Reported Event|Bi-Level PAP|Bi-level pressure delivers two pressures, IPAP and EPAP. Both pressures are fixed and do not adjust based on the individuals breathing events. This is a crossover study, so all patients enter both treatment groups.
228744|NCT01462084|E1|Reported Event|Adaptive Servo-Ventilation (ASV)|Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual. ASV adjusts to the breathing events the individual is experiencing and provides enough PAP to resolve the breathing event. This is a crossover study, so all patients enter both treatment groups.
228745|NCT01462045|B4|Baseline|Total|Total of all reporting groups
228746|NCT01462045|B3|Baseline|Base Group|Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.
228747|NCT01462045|B2|Baseline|Control Group|Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
228748|NCT01462045|B1|Baseline|Exercise Group|Participants who are screened positive for PTSD and participate in the mindfulness-based exercise.
228749|NCT01462045|P3|Participant Flow|Base Group|Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.
228750|NCT01462045|P2|Participant Flow|Control Group|Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
228751|NCT01462045|P1|Participant Flow|Exercise Group|Participants who are screened positive for PTSD and participate in the mindfulness-based exercise.
228752|NCT01462045|O3|Outcome|Base Group|Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.
228753|NCT01462045|O2|Outcome|Control Group|Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
228754|NCT01462045|O1|Outcome|Exercise Group|Participants who are screened positive for PTSD and participate in the mindfulness-based exercise.
228755|NCT01462045|O3|Outcome|Base Group|Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.
228756|NCT01462045|O2|Outcome|Control Group|Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
228757|NCT01462045|O1|Outcome|Exercise Group|Participants who are screened positive for PTSD and participate in the mindfulness-based exercise.
228758|NCT01462045|E3|Reported Event|Base Group|Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.
228759|NCT01462045|E2|Reported Event|Control Group|Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
228760|NCT01462045|E1|Reported Event|Exercise Group|Participants who are screened positive for PTSD and participate in the mindfulness-based exercise.
228761|NCT01461993|B4|Baseline|Total|Total of all reporting groups
228762|NCT01461993|B3|Baseline|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
228763|NCT01461993|B2|Baseline|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
228764|NCT01461993|B1|Baseline|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
228765|NCT01461993|P3|Participant Flow|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
228766|NCT01461993|P2|Participant Flow|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
228767|NCT01461993|P1|Participant Flow|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
228768|NCT01461993|O3|Outcome|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
228769|NCT01461993|O2|Outcome|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
228770|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
228771|NCT01461993|O2|Outcome|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
228772|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
228773|NCT01461993|O2|Outcome|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
228774|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
228775|NCT01461993|O2|Outcome|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
228776|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
228777|NCT01461993|O2|Outcome|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
228778|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
228779|NCT01461993|O2|Outcome|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
228780|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
228781|NCT01461993|O2|Outcome|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
228782|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
228783|NCT01461993|O2|Outcome|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
261440|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
228787|NCT01461993|E1|Reported Event|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
228788|NCT01461980|B4|Baseline|Total|Total of all reporting groups
228789|NCT01461980|B3|Baseline|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
228790|NCT01461980|B2|Baseline|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
228791|NCT01461980|B1|Baseline|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
228792|NCT01461980|P3|Participant Flow|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
228793|NCT01461980|P2|Participant Flow|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
228794|NCT01461980|P1|Participant Flow|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
228795|NCT01461980|O3|Outcome|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
228796|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
228797|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
228798|NCT01461980|O2|Outcome|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
228799|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
228800|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
228801|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
228802|NCT01461980|O2|Outcome|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
228803|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
228804|NCT01461980|O2|Outcome|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
228805|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
228806|NCT01461980|O2|Outcome|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
228807|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
228808|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
228809|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
228810|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
228811|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
228812|NCT01461980|O2|Outcome|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
228813|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
228814|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
228815|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
228816|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
228817|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
228818|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
228819|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
228820|NCT01461980|E3|Reported Event|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
228821|NCT01461980|E2|Reported Event|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
228822|NCT01461980|E1|Reported Event|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
228823|NCT01461824|B4|Baseline|Total|Total of all reporting groups
228824|NCT01461824|B3|Baseline|75mg DMPA|Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
228825|NCT01461824|B2|Baseline|104mg DMPA|Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
228826|NCT01461824|B1|Baseline|150 mg DMPA|Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
228827|NCT01461824|P3|Participant Flow|75mg DMPA|Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
228828|NCT01461824|P2|Participant Flow|104mg DMPA|Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
228829|NCT01461824|P1|Participant Flow|150 mg DMPA|Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
228830|NCT01461824|O3|Outcome|75mg DMPA|Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
228831|NCT01461824|O2|Outcome|104mg DMPA|Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
228832|NCT01461824|O1|Outcome|150 mg DMPA|Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
228833|NCT01461824|O3|Outcome|75mg DMPA|Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
228834|NCT01461824|O2|Outcome|104mg DMPA|Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
228835|NCT01461824|O1|Outcome|150 mg DMPA|Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
228836|NCT01461824|O3|Outcome|75mg DMPA|Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
228837|NCT01461824|O2|Outcome|104mg DMPA|Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
228838|NCT01461824|O1|Outcome|150 mg DMPA|Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
228839|NCT01461824|E3|Reported Event|75 mg DMPA|Depot medroxyprogesterone acetate (DMPA):75mg DMPA, IM, every 12 weeks for 12 months
228840|NCT01461824|E2|Reported Event|104 mg DMPA|Depot medroxyprogesterone acetate (DMPA):104mg DMPA, IM, every 12 weeks for 12 months
228841|NCT01461824|E1|Reported Event|150 mg DMPA|Depot medroxyprogesterone acetate (DMPA):150mg DMPA, IM, every 12 weeks for 12 months
228842|NCT01461811|B3|Baseline|Total|Total of all reporting groups
228843|NCT01461811|B2|Baseline|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
228844|NCT01461811|B1|Baseline|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
228845|NCT01461811|P2|Participant Flow|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
228846|NCT01461811|P1|Participant Flow|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
228847|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
228848|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
228849|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
228850|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
228851|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
228852|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
228853|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
228854|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
228855|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
228856|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
228857|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
228858|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
228859|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
228860|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
228861|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
228862|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
228863|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
228864|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
228865|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
228866|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
228867|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
228868|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
228869|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
228870|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
228871|NCT01461811|E2|Reported Event|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
228872|NCT01461811|E1|Reported Event|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
228873|NCT01461733|B3|Baseline|Total|Total of all reporting groups
228874|NCT01461733|B2|Baseline|Placebo|Placebo: placebo delivered blinded
228875|NCT01461733|B1|Baseline|Amiodarone|"standard dose amiodarone~amiodarone: standard dose amiodarone"
228876|NCT01461733|P2|Participant Flow|Placebo|
228877|NCT01461733|P1|Participant Flow|Amiodarone|standard dose amiodarone
228878|NCT01461733|O2|Outcome|Placebo|Placebo: placebo delivered blinded
228879|NCT01461733|O1|Outcome|Amiodarone|"standard dose amiodarone~amiodarone: standard dose amiodarone"
228880|NCT01461733|E2|Reported Event|Placebo|Placebo: placebo delivered blinded
228881|NCT01461733|E1|Reported Event|Amiodarone|"standard dose amiodarone~amiodarone: standard dose amiodarone"
228882|NCT01461707|B3|Baseline|Total|Total of all reporting groups
228883|NCT01461707|B2|Baseline|Activity Monitor Group|Participants in the group will receive an activity monitor
228884|NCT01461707|B1|Baseline|Mobile App Plus Activity Monitor Group|"Participants in the group will receive a study mobile phone application and an activity monitor~Mobile phone-based physical activity program: Participants in the intervention group will receive an activity monitor and the mobile phone based physical activity intervention."
228885|NCT01461707|P2|Participant Flow|Activity Monitor Group|Participants in the group will receive an activity monitor
228886|NCT01461707|P1|Participant Flow|Mobile App Plus Activity Monitor Group|"Participants in the group will receive a study mobile phone application and an activity monitor~Mobile phone-based physical activity program: Participants in the intervention group will receive an activity monitor and the mobile phone based physical activity intervention."
228887|NCT01461707|O2|Outcome|Activity Monitor Group|Participants in the group will receive an activity monitor
228888|NCT01461707|O1|Outcome|Mobile App Plus Activity Monitor Group|"Participants in the group will receive a study mobile phone application and an activity monitor~Mobile phone-based physical activity program: Participants in the intervention group will receive an activity monitor and the mobile phone based physical activity intervention."
228889|NCT01461707|O2|Outcome|Activity Monitor Group|Participants in the group will receive an activity monitor
228890|NCT01461707|O1|Outcome|Mobile App Plus Activity Monitor Group|"Participants in the group will receive a study mobile phone application and an activity monitor~Mobile phone-based physical activity program: Participants in the intervention group will receive an activity monitor and the mobile phone based physical activity intervention."
228891|NCT01461707|E2|Reported Event|Activity Monitor Group|Participants in the group will receive an activity monitor
228892|NCT01461707|E1|Reported Event|Mobile App Plus Activity Monitor Group|"Participants in the group will receive a study mobile phone application and an activity monitor~Mobile phone-based physical activity program: Participants in the intervention group will receive an activity monitor and the mobile phone based physical activity intervention."
228893|NCT01461668|B3|Baseline|Total|Total of all reporting groups
228894|NCT01461668|B2|Baseline|Placebo|"Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of a placebo with follow up bilateral nares swab one week following completion of therapy (~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (placebo) to begin one week following swab collection (~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (~D47).~Placebo: Two times a day for 5 days"
228895|NCT01461668|B1|Baseline|Retapamulin|"Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of retapamulin with follow up bilateral nares swab one week following completion of therapy (~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (retapamulin) to begin one week following swab collection (~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (~D47).~Retapamulin: Two times a day for 5 days"
228957|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
228896|NCT01461668|P2|Participant Flow|Placebo|"Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of a placebo with follow up bilateral nares swab one week following completion of therapy (~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (placebo) to begin one week following swab collection (~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (~D47).~Placebo: Two times a day for 5 days"
228897|NCT01461668|P1|Participant Flow|Retapamulin|"Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of retapamulin with follow up bilateral nares swab one week following completion of therapy (~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (retapamulin) to begin one week following swab collection (~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (~D47).~Retapamulin: Two times a day for 5 days"
228898|NCT01461668|O2|Outcome|Placebo|"Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of a placebo with follow up bilateral nares swab one week following completion of therapy (~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (placebo) to begin one week following swab collection (~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (~D47).~Placebo: Two times a day for 5 days"
228899|NCT01461668|O1|Outcome|Retapamulin|"Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of retapamulin with follow up bilateral nares swab one week following completion of therapy (~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (retapamulin) to begin one week following swab collection (~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (~D47).~Retapamulin: Two times a day for 5 days"
228900|NCT01461668|E2|Reported Event|Placebo|"Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of a placebo with follow up bilateral nares swab one week following completion of therapy (~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (placebo) to begin one week following swab collection (~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (~D47).~Placebo: Two times a day for 5 days"
228901|NCT01461668|E1|Reported Event|Retapamulin|"Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of retapamulin with follow up bilateral nares swab one week following completion of therapy (~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (retapamulin) to begin one week following swab collection (~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (~D47).~Retapamulin: Two times a day for 5 days"
228902|NCT01461655|B1|Baseline|Topical Retinoid - Placebo, Topical Retinoid - NSAID|"marketed topical retinoid : once daily application, 4 weeks~vehicle gel : once daily application, 4 weeks"
228903|NCT01461655|P1|Participant Flow|Topical Retinoid - Placebo, Topical Retinoid - NSAID|"Using a left-right split face set up, the study evaluated the effect of sequential application of topical retinoid 0.1% gel and NSAID 5% gel in comparison with the sequential application of topical retinoid 0.1% gel and vehicle gel for the treatment of acne vulgaris.~The randomised subjects received the following products:~NSAID 5% gel , in the morning on the appropriate hemiface.~Topical retinoid 0.1% gel, in the evening on the entire face.~Vehicle gel, in the morning on the appropriate hemiface."
228904|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks~marketed topical retinoid : once daily application, 4 weeks"
228905|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks~vehicle gel : once daily application, 4 weeks"
228906|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks~marketed topical retinoid : once daily application, 4 weeks"
228907|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks~vehicle gel : once daily application, 4 weeks"
228908|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks~marketed topical retinoid : once daily application, 4 weeks"
228909|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks~vehicle gel : once daily application, 4 weeks"
228910|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks~marketed topical retinoid : once daily application, 4 weeks"
228911|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks~vehicle gel : once daily application, 4 weeks"
228912|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks~marketed topical retinoid : once daily application, 4 weeks"
228913|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks~vehicle gel : once daily application, 4 weeks"
228914|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks~marketed topical retinoid : once daily application, 4 weeks"
228915|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks~vehicle gel : once daily application, 4 weeks"
228916|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks~marketed topical retinoid : once daily application, 4 weeks"
228917|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks~vehicle gel : once daily application, 4 weeks"
228918|NCT01461655|E1|Reported Event|Topical Retinoid - Placebo, Topical Retinoid - NSAID|
228919|NCT01461551|B4|Baseline|Total|Total of all reporting groups
229003|NCT01461369|B4|Baseline|Total|Total of all reporting groups
229004|NCT01461369|B3|Baseline|Placebo|Placebo: Capsule
228920|NCT01461551|B3|Baseline|Combine of Sevoflurane and Propofol|combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)
228921|NCT01461551|B2|Baseline|Propofol|Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)
228922|NCT01461551|B1|Baseline|Sevoflurane|Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
228923|NCT01461551|P3|Participant Flow|Combine of Sevoflurane and Propofol|combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)
228924|NCT01461551|P2|Participant Flow|Propofol|Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)
228925|NCT01461551|P1|Participant Flow|Sevoflurane|Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
228926|NCT01461551|O3|Outcome|Combine of Sevoflurane and Propofol|combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)
228927|NCT01461551|O2|Outcome|Propofol|Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)
228928|NCT01461551|O1|Outcome|Sevoflurane|Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
228929|NCT01461551|E3|Reported Event|Combine of Sevoflurane and Propofol|combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)
228930|NCT01461551|E2|Reported Event|Propofol|Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)
228931|NCT01461551|E1|Reported Event|Sevoflurane|Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
228932|NCT01461538|B4|Baseline|Total|Total of all reporting groups
228933|NCT01461538|B3|Baseline|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
228934|NCT01461538|B2|Baseline|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
228935|NCT01461538|B1|Baseline|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
228936|NCT01461538|P3|Participant Flow|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
228937|NCT01461538|P2|Participant Flow|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
228938|NCT01461538|P1|Participant Flow|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
228939|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
228940|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
228941|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
228942|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
228943|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
228944|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
228945|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
228946|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
228947|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
228948|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
228949|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
228950|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
228951|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
228952|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
228953|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
228954|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
228955|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
228956|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
228958|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
228959|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
228960|NCT01461538|O2|Outcome|Leukemia|Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
228961|NCT01461538|O1|Outcome|Solid Tumors|Participants with solid tumors
228962|NCT01461538|O2|Outcome|Leukemia|Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
228963|NCT01461538|O1|Outcome|Solid Tumors|Participants with solid tumors
228964|NCT01461538|O2|Outcome|Leukemia|Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
228965|NCT01461538|O1|Outcome|Solid Tumors|Participants with solid tumors
228966|NCT01461538|O2|Outcome|Leukemia|Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
228967|NCT01461538|O1|Outcome|Solid Tumors|Participants with solid tumors
228968|NCT01461538|O2|Outcome|Leukemia|Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
228969|NCT01461538|O1|Outcome|Solid Tumors|Participants with solid tumors
228970|NCT01461538|E3|Reported Event|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
228971|NCT01461538|E2|Reported Event|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
228972|NCT01461538|E1|Reported Event|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
228973|NCT01461499|B3|Baseline|Total|Total of all reporting groups
228974|NCT01461499|B2|Baseline|Angiotensin Receptor Blockers|any angiotensin receptor blockers: The patient will start taking one a standard dose of an ARB in Japan. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of the ARB will be given. In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (DRI, another ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.
228975|NCT01461499|B1|Baseline|Direct Renin Inhibitor|Aliskiren: The patient will start taking one a daily 150 mg/day of aliskiren. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of aliskiren will be given.In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.
228976|NCT01461499|P2|Participant Flow|Angiotensin Receptor Blockers|A total of 118 patients were randomly assigned to receive angiotensin receptor blockers. Four patients dropped out during the observation period and a total of 114 patients were studied in this group.
228977|NCT01461499|P1|Participant Flow|Direct Renin Inhibitor|"Aliskiren:~A total of 119 patients were randomly assigned to receive direct renin inhibitor. Eight patients dropped out during the observation period and a total of 111 patients were studied in this group."
228978|NCT01461499|O2|Outcome|Angiotensin Receptor Blockers|Angiotensin receptor blockers: A total of 378 patients were enrolled for screening, and 141 were not meeting inclusion criteria. Thus, 237 were randomly assigned to receive either direct renin inhibitor (119) or angiotensin receptor blockers (118). Four patients dropped out during the observation period and a total of 114 patients were studied in this group.
228979|NCT01461499|O1|Outcome|Direct Renin Inhibitor|"Aliskiren:~A total of 378 patients were enrolled for screening, and 141 were not meeting inclusion criteria. Thus, 237 were randomly assigned to receive either direct renin inhibitor (119) or angiotensin receptor blockers (118). Eight patients dropped out during the observation period and a total of 111 patients were studied in this group."
228980|NCT01461499|O2|Outcome|Angiotensin Receptor Blockers|"any angiotensin receptor blockers: The patient will start taking one a standard dose of an ARB in Japan. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of the ARB will be given. In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (DRI, another ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.~A total of 378 patients were enrolled for screening, and 141 were not meeting inclusion criteria. Thus, 237 were randomly assigned to receive either direct renin inhibitor (119) or angiotensin receptor blockers (118). Four patients dropped out during the observation period and a total of 114 patients were studied in this group."
228981|NCT01461499|O1|Outcome|Direct Renin Inhibitor|"Aliskiren: The patient will start taking one a daily 150 mg/day of aliskiren. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of aliskiren will be given.In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.~A total of 378 patients were enrolled for screening, and 141 were not meeting inclusion criteria. Thus, 237 were randomly assigned to receive either direct renin inhibitor (119) or angiotensin receptor blockers (118). Eight patients dropped out during the observation period and a total of 111 patients were studied in this group."
228982|NCT01461499|E2|Reported Event|Angiotensin Receptor Blockers|"any angiotensin receptor blockers: The patient will start taking one a standard dose of an ARB in Japan. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of the ARB will be given. In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (DRI, another ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.~378 patients were enrolled for screening, and 237 were randomly assigned to receive either direct renin inhibitor (119) or angiotensin receptor blockers (118). Four patients dropped out during the observation period and a total of 114 patients were studied in this group."
229005|NCT01461369|B2|Baseline|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
229006|NCT01461369|B1|Baseline|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
229007|NCT01461369|P3|Participant Flow|Placebo|Placebo: Capsule
229008|NCT01461369|P2|Participant Flow|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
229009|NCT01461369|P1|Participant Flow|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
228983|NCT01461499|E1|Reported Event|Direct Renin Inhibitor|"Aliskiren: The patient will start taking one a daily 150 mg/day of aliskiren. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of aliskiren will be given.In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.~378 patients were enrolled for screening, and 237 were randomly assigned to receive either direct renin inhibitor (119) or angiotensin receptor blockers (118). Eight patients dropped out during the observation period and a total of 111 patients were studied in this group."
228984|NCT01461473|B3|Baseline|Total|Total of all reporting groups
228985|NCT01461473|B2|Baseline|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).~Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
228986|NCT01461473|B1|Baseline|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).~Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
228987|NCT01461473|P2|Participant Flow|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).~Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
228988|NCT01461473|P1|Participant Flow|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).~Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
228989|NCT01461473|O2|Outcome|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).~Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
228990|NCT01461473|O1|Outcome|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).~Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
228991|NCT01461473|O2|Outcome|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).~Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
228992|NCT01461473|O1|Outcome|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).~Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
228993|NCT01461473|O2|Outcome|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).~Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
228994|NCT01461473|O1|Outcome|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).~Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
228995|NCT01461473|O2|Outcome|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).~Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
228996|NCT01461473|O1|Outcome|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).~Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
228997|NCT01461473|O2|Outcome|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).~Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
228998|NCT01461473|O1|Outcome|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).~Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
228999|NCT01461473|O2|Outcome|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).~Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
229000|NCT01461473|O1|Outcome|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).~Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
229001|NCT01461473|E2|Reported Event|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).~Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
229002|NCT01461473|E1|Reported Event|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).~Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
229029|NCT01461369|E2|Reported Event|Diclofenac 35 mg Three Times Daily|Diclofenac Test (three times daily): Capsules
229030|NCT01461369|E1|Reported Event|Diclofenac 35 mg Two Times Daily|Diclofenac Test (two times daily): Capsules
229031|NCT01461096|B3|Baseline|Total|Total of all reporting groups
229032|NCT01461096|B2|Baseline|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
229033|NCT01461096|B1|Baseline|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
229034|NCT01461096|P2|Participant Flow|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
229035|NCT01461096|P1|Participant Flow|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
229036|NCT01461096|O2|Outcome|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
229037|NCT01461096|O1|Outcome|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
229038|NCT01461096|O2|Outcome|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
229039|NCT01461096|O1|Outcome|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
229040|NCT01461096|O2|Outcome|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
229041|NCT01461096|O1|Outcome|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
229042|NCT01461096|O2|Outcome|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
229043|NCT01461096|O1|Outcome|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
229044|NCT01461096|O2|Outcome|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
229045|NCT01461096|O1|Outcome|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
229046|NCT01461096|E2|Reported Event|Placebo|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
229047|NCT01461096|E1|Reported Event|qHPV|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
229048|NCT01461057|B3|Baseline|Total|Total of all reporting groups
229049|NCT01461057|B2|Baseline|Pertuzumab 840/840 mg|Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg q3w for subsequent cycles.
229409|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229050|NCT01461057|B1|Baseline|Pertuzumab 840/420 mg|Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) q3w for subsequent cycles.
229051|NCT01461057|P2|Participant Flow|Pertuzumab 840/840 mg|Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg q3w for subsequent cycles.
229052|NCT01461057|P1|Participant Flow|Pertuzumab 840/420 mg|Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) q3w for subsequent cycles.
229053|NCT01461057|O2|Outcome|Pertuzumab 840/840 mg|Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg q3w for subsequent cycles.
229054|NCT01461057|O1|Outcome|Pertuzumab 840/420 mg|Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) q3w for subsequent cycles.
229055|NCT01461057|O2|Outcome|Pertuzumab 840/840 mg|Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg q3w for subsequent cycles.
229056|NCT01461057|O1|Outcome|Pertuzumab 840/420 mg|Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) q3w for subsequent cycles.
229057|NCT01461057|E2|Reported Event|Pertuzumab 840/840 mg|Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg q3w for subsequent cycles.
229058|NCT01461057|E1|Reported Event|Pertuzumab 840/420 mg|Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) q3w for subsequent cycles.
229059|NCT01461044|B3|Baseline|Total|Total of all reporting groups
229060|NCT01461044|B2|Baseline|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229061|NCT01461044|B1|Baseline|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229062|NCT01461044|P2|Participant Flow|Bevacizumab: Triple Negative (TN) Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229441|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229063|NCT01461044|P1|Participant Flow|Bevacizumab: Hormone Receptor-Positive (HR+) Breast Cancer|Participants with human epidermal growth factor receptor 2 negative (HER2-) metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for greater than or equal to (>=) 12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229064|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229065|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229066|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229067|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229068|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229069|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229070|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229071|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229072|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229073|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229074|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229573|NCT01458951|P2|Participant Flow|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg tablets, orally, BID for 9 weeks of double blind treatment period.
229075|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229076|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229077|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229078|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229079|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229080|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229081|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229082|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229083|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229084|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229085|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229086|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229193|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229087|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229088|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229089|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229090|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HR+ cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months.
229091|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229092|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229093|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229094|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229095|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229096|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229097|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229098|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229194|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229574|NCT01458951|P1|Participant Flow|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
229099|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229100|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229101|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229102|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229103|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229104|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229105|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229106|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229107|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229108|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229109|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229110|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229195|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229111|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229112|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229113|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229114|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229115|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229116|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229117|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229118|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229119|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229120|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229121|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229122|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229123|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229196|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229124|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229125|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229126|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229127|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229128|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229129|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229130|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229131|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229132|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229133|NCT01461044|E2|Reported Event|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229134|NCT01461044|E1|Reported Event|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
229135|NCT01460940|B1|Baseline|Lenalidomide and Panobinostat|"In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design.~panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days.~lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days."
229136|NCT01460940|P1|Participant Flow|Lenalidomide and Panobinostat|"In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design.~panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days.~lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days."
229137|NCT01460940|O1|Outcome|Lenalidomide and Panobinostat|"In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design.~panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days.~lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days."
229225|NCT01460303|B3|Baseline|Total|Total of all reporting groups
261441|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
229138|NCT01460940|O1|Outcome|Lenalidomide and Panobinostat|"In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design.~panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days.~lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days."
229139|NCT01460940|O1|Outcome|Lenalidomide and Panobinostat|"In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design.~panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days.~lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days."
229140|NCT01460940|E1|Reported Event|Lenalidomide and Panobinostat|"In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design.~panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days.~lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days."
229141|NCT01460927|B1|Baseline|TriActive+ RF|Healthy male or female subjects 30-60 years of age, having at least two facial sub-areas (left peri-orbital, right peri-orbital or peri-oral) with visible lines/wrinkles and elastosis, which correlate to a score of 2-6 on the Fitzpatrick Classification of Wrinkling and Degree of Elastosis.
229142|NCT01460927|P1|Participant Flow|TriActive+RF|"Subjects will receive up to 8 treatments on at least two facial sub areas (e.g., left peri-orbital, right peri-orbital and/or peri-oral). Treatments will be administered once a week (±2days) with evaluation follow-up visits at one (1) week (±2days), one (1) month (±4days), and three (3) months (±4days) following the final treatment. The treatments start at a low power (3W for the small tip, 10W for the medium and large tips) and then gradually increase the setting up to the highest powers available within the tips, checking the subject’s tolerability and reaction of the tissue.~The power is adjusted to suit the subject’s sensitivity and the “depth” of tissue to be treated (deeper tissue requires the larger tip). The goal is to progressively and smoothly reach an epidermal temperature end-point of 43°C. The treatment end-point correlates directly with the measurement of the skin temperature.~The temperature of 43°C should be maintained at the end point for several minutes (3-5min)."
229143|NCT01460927|O5|Outcome|3 Month FU|3 Months after the 8th treatment
229144|NCT01460927|O4|Outcome|1 Month FU|1 Month after the 8th treatment
229145|NCT01460927|O3|Outcome|Pre Treatment 8|After 7 treatments
229146|NCT01460927|O2|Outcome|Pre Treatment 4|After 3 treatments
229147|NCT01460927|O1|Outcome|Baseline|Baseline (before Treatments)
229148|NCT01460927|E1|Reported Event|TriActive+RF|Subjects will receive up to 8 treatments with the TriActive+ RF on at least two facial sub areas (e.g., left peri-orbital, right peri-orbital and/or peri-oral). Treatments will be administered once a week (±2 days).
229149|NCT01460732|B1|Baseline|All Patients|All patients analyzed
229150|NCT01460732|P1|Participant Flow|All Patients|All patients analyzed
229151|NCT01460732|O2|Outcome|HBPM-Nocturnal|Dippers defined by HBPM-Nocturnal.
229152|NCT01460732|O1|Outcome|ABPM|Dippers defined by ABPM.
229153|NCT01460732|O1|Outcome|All Patients|All patients analyzed
229154|NCT01460732|O1|Outcome|All Patients|All patients analyzed
229155|NCT01460732|O1|Outcome|All Patients|All patients analyzed
229156|NCT01460732|O1|Outcome|All Patients|All patients analyzed
229157|NCT01460732|O1|Outcome|All Patients|All patients analyzed
229158|NCT01460732|O1|Outcome|All Patients|All patients analyzed
229159|NCT01460732|O1|Outcome|All Patients|All patients analyzed
229160|NCT01460732|O1|Outcome|All Patients|All patients analyzed
229161|NCT01460732|E1|Reported Event|All Patients|All patients analyzed
229162|NCT01460628|B1|Baseline|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
229163|NCT01460628|P1|Participant Flow|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
229164|NCT01460628|O1|Outcome|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
229165|NCT01460628|O1|Outcome|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
229166|NCT01460628|O1|Outcome|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
229167|NCT01460628|O1|Outcome|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
229168|NCT01460628|O1|Outcome|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
229169|NCT01460628|O1|Outcome|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
229170|NCT01460628|O1|Outcome|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
229171|NCT01460628|E1|Reported Event|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
229172|NCT01460446|B3|Baseline|Total|Total of all reporting groups
229173|NCT01460446|B2|Baseline|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229174|NCT01460446|B1|Baseline|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229175|NCT01460446|P2|Participant Flow|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229176|NCT01460446|P1|Participant Flow|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229177|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229178|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229179|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229180|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229181|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229182|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229183|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229184|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229185|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229186|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229187|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229188|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229189|NCT01460446|O1|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229190|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229191|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229192|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
261442|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
229197|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229198|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229199|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229200|NCT01460446|E2|Reported Event|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229201|NCT01460446|E1|Reported Event|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
229202|NCT01460342|B3|Baseline|Total|Total of all reporting groups
229203|NCT01460342|B2|Baseline|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
229204|NCT01460342|B1|Baseline|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
229205|NCT01460342|P2|Participant Flow|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
229206|NCT01460342|P1|Participant Flow|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
229207|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
229208|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
229209|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
229210|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
229211|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
229212|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
229213|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
229214|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
229215|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
229216|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
229217|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
229218|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
229219|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
229220|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
229221|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
229222|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
229223|NCT01460342|E2|Reported Event|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
229224|NCT01460342|E1|Reported Event|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
229226|NCT01460303|B2|Baseline|Transurethral Catheter w/Leg Bag|"Patients who fail postop bladder challenge and are randomized to indwelling catheter with leg bag arm will be instructed in the use and care of this catheter, discharged home with it in place and given an appointment between 5-10 days postop for a bladder challenge.~Transurethral catheter with leg bag: Transurethral catheter w/leg bag urine storage, worn maximum of 30 days post-up until bladder challenge is passed. Bladder challenge is considered passed when a patient is able to void adequately and spontaneously (without the assistance of a catheter)."
229227|NCT01460303|B1|Baseline|OPTION-vf Patient Controlled Catheter|"Patients who fail postop bladder challenge and are randomized to OPTION-vf arm will be instructed in the use and care of this catheter, discharged home with it in place and given an appointment between 5-10 days postop for a bladder challenge.~Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag: OPTION-vf patient controlled catheter (transurethral catheter with external drainage valve to provide on-demand drainage of urine stored directly from the bladder), worn maximum of 30 days post-op until bladder challenge is passed. Bladder challenge is considered passed when a patient is able to void adequately and spontaneously (without the assistance of a catheter)."
229228|NCT01460303|P2|Participant Flow|Transurethral Catheter w/Leg Bag|"Patients who fail postop bladder challenge and are randomized to indwelling catheter with leg bag arm will be instructed in the use and care of this catheter, discharged home with it in place and given an appointment between 5-10 days postop for a bladder challenge.~Transurethral catheter with leg bag: Transurethral catheter w/leg bag urine storage, worn maximum of 30 days post-up until bladder challenge is passed. Bladder challenge is considered passed when a patient is able to void adequately and spontaneously (without the assistance of a catheter)."
229229|NCT01460303|P1|Participant Flow|OPTION-vf Patient Controlled Catheter|"Patients who fail postop bladder challenge and are randomized to OPTION-vf arm will be instructed in the use and care of this catheter, discharged home with it in place and given an appointment between 5-10 days postop for a bladder challenge.~Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag: OPTION-vf patient controlled catheter (transurethral catheter with external drainage valve to provide on-demand drainage of urine stored directly from the bladder), worn maximum of 30 days post-op until bladder challenge is passed. Bladder challenge is considered passed when a patient is able to void adequately and spontaneously (without the assistance of a catheter)."
229230|NCT01460303|O2|Outcome|Transurethral Catheter w/Leg Bag|"Patients who fail postop bladder challenge and are randomized to indwelling catheter with leg bag arm.~Transurethral catheter with leg bag: Transurethral catheter w/leg bag urine storage, worn maximum of 30 days post-up until bladder challenge is passed. Bladder challenge is considered passed when a patient is able to void adequately and spontaneously (without the assistance of a catheter)."
229231|NCT01460303|O1|Outcome|OPTION-vf Patient Controlled Catheter|"Patients who fail postop bladder challenge and are randomized to OPTION-vf arm.~Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag: OPTION-vf patient controlled catheter (transurethral catheter with external drainage valve to provide on-demand drainage of urine stored directly from the bladder), worn maximum of 30 days post-op until bladder challenge is passed. Bladder challenge is considered passed when a patient is able to void adequately and spontaneously (without the assistance of a catheter)."
229232|NCT01460303|O2|Outcome|Transurethral Catheter w/Leg Bag|"Patients who fail postop bladder challenge and are randomized to indwelling catheter with leg bag arm.~Transurethral catheter with leg bag: Transurethral catheter w/leg bag urine storage, worn maximum of 30 days post-up until bladder challenge is passed. Bladder challenge is considered passed when a patient is able to void adequately and spontaneously (without the assistance of a catheter)."
229233|NCT01460303|O1|Outcome|OPTION-vf Patient Controlled Catheter|"Patients who fail postop bladder challenge and are randomized to OPTION-vf arm.~Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag: OPTION-vf patient controlled catheter (transurethral catheter with external drainage valve to provide on-demand drainage of urine stored directly from the bladder), worn maximum of 30 days post-op until bladder challenge is passed. Bladder challenge is considered passed when a patient is able to void adequately and spontaneously (without the assistance of a catheter)."
229234|NCT01460303|E2|Reported Event|Transurethral Catheter w/Leg Bag|"Patients who fail postop bladder challenge and are randomized to indwelling catheter with leg bag arm will be instructed in the use and care of this catheter, discharged home with it in place and given an appointment between 5-10 days postop for a bladder challenge.~Transurethral catheter with leg bag: Transurethral catheter w/leg bag urine storage, worn maximum of 30 days post-up until bladder challenge is passed. Bladder challenge is considered passed when a patient is able to void adequately and spontaneously (without the assistance of a catheter)."
229235|NCT01460303|E1|Reported Event|OPTION-vf Patient Controlled Catheter|"Patients who fail postop bladder challenge and are randomized to OPTION-vf arm will be instructed in the use and care of this catheter, discharged home with it in place and given an appointment between 5-10 days postop for a bladder challenge.~Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag: OPTION-vf patient controlled catheter (transurethral catheter with external drainage valve to provide on-demand drainage of urine stored directly from the bladder), worn maximum of 30 days post-op until bladder challenge is passed. Bladder challenge is considered passed when a patient is able to void adequately and spontaneously (without the assistance of a catheter)."
229236|NCT01460290|B1|Baseline|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg/day and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study."
229237|NCT01460290|P1|Participant Flow|Asenapine|12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
229238|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
229442|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229239|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
229240|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
229241|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
229242|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
229243|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
229244|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
229245|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
229246|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
229247|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
229248|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
229249|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
229250|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
229251|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
229252|NCT01460290|O1|Outcome|Asenapine|12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
229253|NCT01460290|O1|Outcome|Asenapine|12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
229254|NCT01460290|O1|Outcome|Asenapine|12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
229255|NCT01460290|E1|Reported Event|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
229256|NCT01459913|B5|Baseline|Total|Total of all reporting groups
229307|NCT01459796|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
229257|NCT01459913|B4|Baseline|Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
229258|NCT01459913|B3|Baseline|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
229259|NCT01459913|B2|Baseline|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
229260|NCT01459913|B1|Baseline|Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
229261|NCT01459913|P4|Participant Flow|Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
229262|NCT01459913|P3|Participant Flow|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
229263|NCT01459913|P2|Participant Flow|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
229264|NCT01459913|P1|Participant Flow|Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met rapid viral response (RVR, undetectable Hepatitis C Virus [HCV] Ribonucleic Acid [RNA] at Week 4) criteria, were randomized in this group, as planned, and did not receive any further treatment.
229265|NCT01459913|O4|Outcome|Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
229266|NCT01459913|O3|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
229267|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
229268|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
229269|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
229575|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
229270|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
229271|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
229272|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
229273|NCT01459913|O5|Outcome|Telaprevir+Peg-IFN-alfa-2a, RBV (Total)|All subjects who received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, up to 48 weeks.
229274|NCT01459913|O4|Outcome|Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
229275|NCT01459913|O3|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
229276|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
229277|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
229278|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
229279|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
229280|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
229281|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
229282|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
229283|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
229308|NCT01459796|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
231395|NCT01454583|B1|Baseline|Group A|Patients treated with Aliskiren (DRI)
229284|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
229285|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
229286|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
229287|NCT01459913|O1|Outcome|Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
229288|NCT01459913|E4|Reported Event|Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
229289|NCT01459913|E3|Reported Event|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
229290|NCT01459913|E2|Reported Event|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
229291|NCT01459913|E1|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
229292|NCT01459796|B3|Baseline|Total|Total of all reporting groups
229293|NCT01459796|B2|Baseline|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
229294|NCT01459796|B1|Baseline|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
229295|NCT01459796|P2|Participant Flow|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
229296|NCT01459796|P1|Participant Flow|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 51.
229297|NCT01459796|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
229298|NCT01459796|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
229299|NCT01459796|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
229300|NCT01459796|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
229301|NCT01459796|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
229302|NCT01459796|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
229303|NCT01459796|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
229304|NCT01459796|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
229305|NCT01459796|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
229306|NCT01459796|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
261443|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
229309|NCT01459796|E2|Reported Event|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
229310|NCT01459796|E1|Reported Event|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
229311|NCT01459783|B3|Baseline|Total|Total of all reporting groups
229312|NCT01459783|B2|Baseline|Dementia Care Management Telephone Only|"The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up."
229313|NCT01459783|B1|Baseline|Dementia Care Management in Person|"The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems."
229314|NCT01459783|P2|Participant Flow|Dementia Care Management Telephone Only|"The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up."
229315|NCT01459783|P1|Participant Flow|Dementia Care Management in Person|"The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems."
229316|NCT01459783|O2|Outcome|Dementia Care Management Telephone Only|"The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up."
229317|NCT01459783|O1|Outcome|Dementia Care Management in Person|"The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems."
229329|NCT01459705|O2|Outcome|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
229378|NCT01459653|O1|Outcome|EP2006: Any CIN/FN-related Chemotherapy Disturbance|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN who had any CIN/FN-related chemotherapy disturbance
229576|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
229318|NCT01459783|O2|Outcome|Dementia Care Management Telephone Only|"The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up."
229319|NCT01459783|O1|Outcome|Dementia Care Management in Person|"The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems."
229320|NCT01459783|E2|Reported Event|Dementia Care Management Telephone Only|"The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up."
229321|NCT01459783|E1|Reported Event|Dementia Care Management in Person|"The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems."
229322|NCT01459705|B4|Baseline|Total|Total of all reporting groups
229323|NCT01459705|B3|Baseline|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.~Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
229324|NCT01459705|B2|Baseline|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
229325|NCT01459705|B1|Baseline|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
229326|NCT01459705|P3|Participant Flow|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.~Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
229327|NCT01459705|P2|Participant Flow|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
229328|NCT01459705|P1|Participant Flow|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
229375|NCT01459653|O2|Outcome|EP2006: Secondary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN
229376|NCT01459653|O1|Outcome|EP2006: Primary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN.
229330|NCT01459705|O1|Outcome|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
229331|NCT01459705|O2|Outcome|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
229332|NCT01459705|O1|Outcome|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
229333|NCT01459705|O3|Outcome|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.~Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
229334|NCT01459705|O2|Outcome|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
229335|NCT01459705|O1|Outcome|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
229336|NCT01459705|O3|Outcome|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.~Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
229337|NCT01459705|O2|Outcome|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
229338|NCT01459705|O1|Outcome|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
229339|NCT01459705|O3|Outcome|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.~Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
229340|NCT01459705|O2|Outcome|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
229341|NCT01459705|O1|Outcome|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
229342|NCT01459705|E3|Reported Event|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.~Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
229343|NCT01459705|E2|Reported Event|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
229377|NCT01459653|O2|Outcome|EP2006: No CIN/FN-related Chemotherapy Disturbance|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN who had no CIN/FN-related chemotherapy disturbance
229577|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
229344|NCT01459705|E1|Reported Event|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
229345|NCT01459653|B1|Baseline|EP2006, Evaluable Sample|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. Only patients who had no major protocol violations and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data) belong to the evaluable sample and are analyzed.
229346|NCT01459653|P1|Participant Flow|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229347|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN
229348|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229349|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229350|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229351|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN
229352|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229353|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229354|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229355|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229356|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229357|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229358|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229359|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229360|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229361|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229362|NCT01459653|O2|Outcome|EP2006 - Group 2|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229363|NCT01459653|O1|Outcome|EP2006 - Group 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229364|NCT01459653|O2|Outcome|EP2006 - Group 2|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229365|NCT01459653|O1|Outcome|EP2006 - Group 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229366|NCT01459653|O2|Outcome|EP2006 - Group 2|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229367|NCT01459653|O1|Outcome|EP2006 - Group 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229368|NCT01459653|O2|Outcome|EP2006 - Group 2|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229369|NCT01459653|O1|Outcome|EP2006 - Group 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229370|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229371|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229372|NCT01459653|O3|Outcome|EP2006: Over Treated|Over treated cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229373|NCT01459653|O2|Outcome|EP2006: Correctly Treated|Correctly treated cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229374|NCT01459653|O1|Outcome|EP2006: Undertreated|Undertreated cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229662|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229379|NCT01459653|O2|Outcome|EP2006: No Grade 4 CIN/FN|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with no grade 4 CIN/FN
229380|NCT01459653|O1|Outcome|EP2006: Any Grade 4 CIN/FN|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with any grade 4 CIN/FN
229381|NCT01459653|O2|Outcome|EP2006: no CIN/FN-related Chemotherapy Disturbance|Cancer patients having no CIN/FN-related chemotherapy disturbance treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229382|NCT01459653|O1|Outcome|EP2006: Any CIN/FN-related Chemotherapy Disturbance|Cancer patients having any CIN/FN-related chemotherapy disturbance treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229383|NCT01459653|O2|Outcome|EP2006: No Grade 4 CIN/FN|Cancer patients with no grade 4 CIN/FIN treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229384|NCT01459653|O1|Outcome|EP2006: Any Grade 4 CIN/FN|Cancer patients with any grade 4 CIN/FIN treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229385|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229386|NCT01459653|O3|Outcome|EP2006: >=6 Days Duration|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with >=6 days of study drug duration.
229387|NCT01459653|O2|Outcome|EP2006: 4-5 Days Duration|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with 4-5 days of study drug duration.
229388|NCT01459653|O1|Outcome|EP2006: 1-3 Days Duration|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with 1-3 days of study drug duration.
229389|NCT01459653|O3|Outcome|EP2006: Day 4 or Later|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on day 4 or later
229390|NCT01459653|O2|Outcome|EP2006: Days 1-3 (Per Guidelines)|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on days 1-3 (per guidelines)
229391|NCT01459653|O1|Outcome|EP2006: Day 0 (During Chemotherapy)|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on day 0 (during chemotherapy)
229392|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229393|NCT01459653|O3|Outcome|EP2006: Mean GIS 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 1
229394|NCT01459653|O2|Outcome|EP2006: Mean GIS 0.51-0.99|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 0.51-0.99
229395|NCT01459653|O1|Outcome|EP2006: Mean GIS 0-0.5|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 0-0.5
229396|NCT01459653|O2|Outcome|EP2006: 48MIU/Day|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, treated with 48MIU/day
229397|NCT01459653|O1|Outcome|EP2006: 30MIU/Day|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, treated with 30MIU/day
229398|NCT01459653|O3|Outcome|EP2006: Overtreated|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, overtreated relative to guidelines.
229399|NCT01459653|O2|Outcome|EP2006: Correctly Treated|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, correctly treated relative to guidelines
229400|NCT01459653|O1|Outcome|EP2006: Undertreated|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, undertreated relative to guidelines
229401|NCT01459653|O2|Outcome|EP2006: Secondary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN
229402|NCT01459653|O1|Outcome|EP2006: Primary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN
229403|NCT01459653|O3|Outcome|EP2006: High (>20%) Risk|Cancer patients treated with chemotherapy with high risk(>20%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229404|NCT01459653|O2|Outcome|EP2006: Medium (10-20%) Risk|Cancer patients treated with chemotherapy with medium risk(10-20%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229405|NCT01459653|O1|Outcome|EP2006: Low (<10%) Risk|Cancer patients treated with chemotherapy with low risk(<10%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229406|NCT01459653|O1|Outcome|EP2006 Cycle Level|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229407|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229408|NCT01459653|O1|Outcome|EP2006 Cycles|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
231464|NCT01454583|E1|Reported Event|Group A|Patients treated with Aliskiren (DRI)
229410|NCT01459653|O3|Outcome|EP2006 - Hematological Tumor|Cancer patients (Hematological tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229411|NCT01459653|O2|Outcome|EP2006 - Solid Tumor|Cancer patients (Solid tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229412|NCT01459653|O1|Outcome|EP2006 - All Patients|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229413|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229414|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229415|NCT01459653|O3|Outcome|EP2006: EP2006 Initiation Later (Day 4 or More)^|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (EP2006 initiation later (day 4 or more).
229416|NCT01459653|O2|Outcome|EP2006: EP 2006 Initiation Per Guidelines (Days 1-3)|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (EP 2006 initiation per guidelines (days 1-3).
229417|NCT01459653|O1|Outcome|EP2006: EP2006 Initiation During Chemotherapy (Day 0)|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (EP2006 initiation during chemotherapy, day 0).
229418|NCT01459653|O3|Outcome|EP2006: Hematological Tumor|Cancer patients (Hematological tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229419|NCT01459653|O2|Outcome|EP2006: Solid Tumor|Cancer patients (Solid tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229420|NCT01459653|O1|Outcome|EP2006: All Patients|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229421|NCT01459653|O3|Outcome|EP2006, <10% Chemo-associated FN Risk|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (<10% chemo-associated FN risk).
229422|NCT01459653|O2|Outcome|EP2006, 10-20% Chemo-associated FN Risk|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (10-20% chemo-associated FN risk).
229423|NCT01459653|O1|Outcome|EP2006, >20% Chemo-associated FN Risk|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (>20% chemo-associated FN risk)
229424|NCT01459653|O3|Outcome|EP2006 - Hematological Tumor|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (Hematological tumor).
229425|NCT01459653|O2|Outcome|EP2006 - Solid Tumor|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (Solid tumor).
229426|NCT01459653|O1|Outcome|EP2006 - All Patients|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (all patients).
229427|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229428|NCT01459653|O2|Outcome|EP2006 - Group 2|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229429|NCT01459653|O1|Outcome|EP2006 - Group 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229430|NCT01459653|O1|Outcome|EP2006 - Group 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229431|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229432|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229433|NCT01459653|O3|Outcome|EP2006: >20% Risk|Cancer patients treated with chemotherapy with high toxicity (>20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229434|NCT01459653|O2|Outcome|EP2006: 10-20% Risk|Cancer patients treated with chemotherapy with medium toxicity (10-20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229435|NCT01459653|O1|Outcome|EP2006: <10% Risk|Cancer patients treated with chemotherapy with low toxicity (<10% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229436|NCT01459653|O2|Outcome|EP2006: Secondary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN.
229437|NCT01459653|O1|Outcome|EP2006: Primary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN.
229438|NCT01459653|O2|Outcome|EP2006: Hematological Tumor|Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229439|NCT01459653|O1|Outcome|EP2006: Solid Tumor|Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229440|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229663|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229443|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229444|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229445|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229446|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229447|NCT01459653|O3|Outcome|EP2006: >20% Risk|Cancer patients treated with chemotherapy with high toxicity (>20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229448|NCT01459653|O2|Outcome|EP2006: 10-20% Risk|Cancer patients treated with chemotherapy with medium toxicity (10-20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229449|NCT01459653|O1|Outcome|EP2006: <10% Risk|Cancer patients treated with chemotherapy with low toxicity (<10% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229450|NCT01459653|O2|Outcome|EP2006: Secondary Prophylaxis|Cancer patients treated with chemotherapy as and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN.
229451|NCT01459653|O1|Outcome|EP2006: Primary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN.
229452|NCT01459653|O2|Outcome|EP2006: Hematological Tumor|Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229453|NCT01459653|O1|Outcome|EP2006: Solid Tumor|Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229454|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229455|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229456|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229457|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229458|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229459|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229460|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229461|NCT01459653|O3|Outcome|EP2006: Risk >20%|Cancer patients with chemotherapy toxicity >20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229462|NCT01459653|O2|Outcome|EP2006: Risk 10-20%|Cancer patients with chemotherapy toxicity 10-20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229463|NCT01459653|O1|Outcome|EP2006: Risk <10%|Cancer patients with chemotherapy toxicity <10% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229464|NCT01459653|O2|Outcome|EP2006: Hematological Tumor|Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229465|NCT01459653|O1|Outcome|EP2006: Solid Tumor|Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229466|NCT01459653|O2|Outcome|EP2006: Hematological Tumor|Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229467|NCT01459653|O1|Outcome|EP2006: Solid Tumor|Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229468|NCT01459653|O2|Outcome|EP2006: >65kg|Cancer patients weighing >65kg treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229469|NCT01459653|O1|Outcome|EP2006: <=65kg|Cancer patients weighing <=65kg treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229470|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229471|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229472|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229473|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229474|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229475|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
231899|NCT01453374|O1|Outcome|<7 Injections|Subjects who received less than 7 VIVITROL injections
229476|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229477|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229478|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229479|NCT01459653|O2|Outcome|EP2006: Hematological Tumor|Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229480|NCT01459653|O1|Outcome|EP2006: Solid Tumor|Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229481|NCT01459653|O2|Outcome|EP2006: >=65 Years|Cancer patients >=65 years treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229482|NCT01459653|O1|Outcome|EP2006: <65 Years|Cancer patients <65 years treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229483|NCT01459653|O2|Outcome|EP2006: Female|Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229484|NCT01459653|O1|Outcome|EP2006: Male|Male cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229485|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229486|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229487|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229488|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229489|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
229490|NCT01459653|E1|Reported Event|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. Number 1496 refers to the total number of patients who received at least one dose of study medication EP2006.
229491|NCT01459588|B5|Baseline|Total|Total of all reporting groups
229492|NCT01459588|B4|Baseline|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
229493|NCT01459588|B3|Baseline|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
229494|NCT01459588|B2|Baseline|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
229495|NCT01459588|B1|Baseline|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
229496|NCT01459588|P4|Participant Flow|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
229497|NCT01459588|P3|Participant Flow|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
229498|NCT01459588|P2|Participant Flow|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
229499|NCT01459588|P1|Participant Flow|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
229500|NCT01459588|O4|Outcome|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
229501|NCT01459588|O3|Outcome|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
229502|NCT01459588|O2|Outcome|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
229503|NCT01459588|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
229504|NCT01459588|O4|Outcome|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
229505|NCT01459588|O3|Outcome|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
229506|NCT01459588|O2|Outcome|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
261444|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
229507|NCT01459588|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
229508|NCT01459588|O4|Outcome|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
229509|NCT01459588|O3|Outcome|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
229510|NCT01459588|O2|Outcome|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
229511|NCT01459588|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
229512|NCT01459588|O4|Outcome|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
229513|NCT01459588|O3|Outcome|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
229514|NCT01459588|O2|Outcome|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
229515|NCT01459588|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
229516|NCT01459588|O4|Outcome|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
229517|NCT01459588|O3|Outcome|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
229518|NCT01459588|O2|Outcome|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
229519|NCT01459588|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
229520|NCT01459588|E4|Reported Event|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
229521|NCT01459588|E3|Reported Event|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
229522|NCT01459588|E2|Reported Event|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
229523|NCT01459588|E1|Reported Event|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
229524|NCT01459068|B3|Baseline|Total|Total of all reporting groups
229525|NCT01459068|B2|Baseline|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
229526|NCT01459068|B1|Baseline|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
229527|NCT01459068|P2|Participant Flow|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
229528|NCT01459068|P1|Participant Flow|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
229542|NCT01459068|E1|Reported Event|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
229543|NCT01459016|B1|Baseline|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
229529|NCT01459068|O2|Outcome|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
229530|NCT01459068|O1|Outcome|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
229531|NCT01459068|O2|Outcome|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
229532|NCT01459068|O1|Outcome|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
229533|NCT01459068|O2|Outcome|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
229534|NCT01459068|O1|Outcome|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
229535|NCT01459068|O2|Outcome|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
229536|NCT01459068|O1|Outcome|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
229537|NCT01459068|O2|Outcome|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
229538|NCT01459068|O1|Outcome|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
229539|NCT01459068|O2|Outcome|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
229540|NCT01459068|O1|Outcome|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
229541|NCT01459068|E2|Reported Event|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
261445|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
229544|NCT01459016|P1|Participant Flow|Standard of Care|Participants with prodromal to mild Alzheimer’s Disease (AD) underwent a florbetapir F 18 positron emission tomography (PET) scan. (Single intravenous microdose of 260 to 370 megabecquerels (MBq) [7 to 10 millicuries (mCi)] of florbetapir.) Those who tested amyloid positive and met other entry criteria received standard of care for up to 12 months (mos). No therapeutic investigational drug intended to treat AD was administered.
229545|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
229546|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
229547|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
229548|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
229549|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
229550|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
229551|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
229552|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
229553|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
229554|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
229555|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
229556|NCT01459016|E1|Reported Event|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
229557|NCT01458990|B3|Baseline|Total|Total of all reporting groups
229558|NCT01458990|B2|Baseline|PPI Withdrawal|The intervention here is systematically withdrawing chronic PPI for 14 days
229559|NCT01458990|B1|Baseline|PPI Inititation|Adding 40mg omeprazole QD for 14 days
229560|NCT01458990|P2|Participant Flow|PPI Withdrawal|The intervention here is systematically withdrawing chronic PPI for 14 days
229561|NCT01458990|P1|Participant Flow|PPI Inititation|Adding 40mg omeprazole QD for 14 days
229562|NCT01458990|O2|Outcome|PPI Withdrawal|No safety signals were identified
229563|NCT01458990|O1|Outcome|PPI Initiation|No safety signals were identified
229564|NCT01458990|O2|Outcome|PPI Withdrawal|"The intervention here is systematically withdrawing chronic PPI for 14 days~Omeprazole: 20mg PO BID for 20 days"
229565|NCT01458990|O1|Outcome|PPI Inititation|"Adding 40mg omeprazole QD for 14 days~Omeprazole: 20mg PO BID for 20 days"
229566|NCT01458990|E2|Reported Event|PPI Withdrawal|The intervention here is systematically withdrawing chronic PPI for 14 days
229567|NCT01458990|E1|Reported Event|PPI Inititation|Adding 40mg omeprazole QD for 14 days
229568|NCT01458951|B4|Baseline|Total|Total of all reporting groups
229569|NCT01458951|B3|Baseline|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
229570|NCT01458951|B2|Baseline|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg tablets, orally, BID for 9 weeks of double blind treatment period.
229571|NCT01458951|B1|Baseline|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
229572|NCT01458951|P3|Participant Flow|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
229664|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229578|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
229579|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
229580|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
229581|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
229582|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
229583|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
229584|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
229585|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
229586|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
229587|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
229588|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
229589|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
229590|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
229591|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
229592|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
229593|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
229594|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
229595|NCT01458951|E3|Reported Event|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
229596|NCT01458951|E2|Reported Event|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg tablets, orally, BID for 9 weeks of double blind treatment period.
229597|NCT01458951|E1|Reported Event|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
229598|NCT01458639|B1|Baseline|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
229599|NCT01458639|P1|Participant Flow|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
229600|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
229601|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
229602|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
229603|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
229604|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
229605|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
229606|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
229607|NCT01458639|E1|Reported Event|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
229608|NCT01458587|B3|Baseline|Total|Total of all reporting groups
229609|NCT01458587|B2|Baseline|Vehicle|Vehicle applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
261446|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
229610|NCT01458587|B1|Baseline|Aminolevulinic Acid|ALA applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
229611|NCT01458587|P2|Participant Flow|Vehicle|Vehicle applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
229612|NCT01458587|P1|Participant Flow|Aminolevulinic Acid|ALA applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
229613|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229614|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229615|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229616|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229617|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229618|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229619|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229620|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229621|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229622|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229623|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229624|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229625|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229626|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229627|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229628|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229629|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229630|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229631|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229632|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229633|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229634|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229635|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229636|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229637|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229638|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229639|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229640|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229641|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229642|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229643|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229644|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229645|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229646|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229647|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229648|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229649|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229650|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229651|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229652|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229653|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229654|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229655|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229656|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229657|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229658|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229659|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229660|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229661|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229665|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229666|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229667|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229668|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229669|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229670|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229671|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229672|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229673|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229674|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229675|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229676|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229677|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229678|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229679|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229680|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229681|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229682|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229683|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229684|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229685|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229686|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229687|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229688|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229689|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229690|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229691|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229692|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229693|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229694|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229695|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229696|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229697|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229698|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229699|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229700|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229701|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229702|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229703|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229704|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229705|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229706|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229707|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229708|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229709|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229710|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229711|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229712|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229713|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229714|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229715|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229716|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229717|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
261447|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
229718|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229719|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229720|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229721|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229722|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229723|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229724|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229725|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229726|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229727|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229728|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229729|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229730|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229731|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229732|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229733|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229734|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229735|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229736|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229737|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229738|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229739|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229740|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229741|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229742|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229743|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229744|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229745|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229746|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229747|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229748|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229749|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229750|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229751|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229752|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229753|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229754|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229755|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229756|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229757|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229758|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229759|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229760|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229761|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229762|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229763|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229764|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229765|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
229766|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
229767|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
229768|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
229769|NCT01458587|E2|Reported Event|Vehicle|Vehicle applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
230036|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
229770|NCT01458587|E1|Reported Event|Aminolevulinic Acid|ALA applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
229771|NCT01458574|B4|Baseline|Total|Total of all reporting groups
229772|NCT01458574|B3|Baseline|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229773|NCT01458574|B2|Baseline|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229774|NCT01458574|B1|Baseline|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229775|NCT01458574|P3|Participant Flow|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229776|NCT01458574|P2|Participant Flow|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229777|NCT01458574|P1|Participant Flow|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229778|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229779|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229780|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229781|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229782|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229783|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229784|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229785|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229786|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229787|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229788|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229789|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229790|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229791|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229792|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229793|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229794|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229795|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229796|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229797|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229798|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229799|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
261448|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
229800|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229801|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229802|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229803|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229804|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229805|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229806|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229807|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229808|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229809|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229810|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229811|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229812|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229813|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229814|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229815|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229816|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229817|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229818|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229819|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229820|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229821|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229822|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229823|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229824|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229825|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229826|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229827|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229828|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
232360|NCT01451983|O4|Outcome|Siblings|Siblings of individuals with autism spectrum disorders.
229829|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229830|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229831|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229832|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229833|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229834|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229835|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229836|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229837|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229838|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229839|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229840|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229841|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229842|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229843|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229844|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229845|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229846|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229847|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229848|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229849|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229850|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229851|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229852|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229853|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229854|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229855|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229856|NCT01458574|E3|Reported Event|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229857|NCT01458574|E2|Reported Event|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
230515|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
229858|NCT01458574|E1|Reported Event|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
229859|NCT01458561|B3|Baseline|Total|Total of all reporting groups
229860|NCT01458561|B2|Baseline|Gelfoam Plus|"Control of bleeding using Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
229861|NCT01458561|B1|Baseline|BioFoam Surgical Matrix|"Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
229862|NCT01458561|P2|Participant Flow|Gelfoam Plus|"Control of bleeding using Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
229863|NCT01458561|P1|Participant Flow|BioFoam Surgical Matrix|"Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
229864|NCT01458561|O2|Outcome|Complications/Adverse Events in Subj. Receiving Gelfoam Plus|"Number of complications/adverse events recorded for subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
229865|NCT01458561|O1|Outcome|Complications/Adverse Events in Subjects Receiving BioFoam|"Number of complications/adverse events recorded for subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
229866|NCT01458561|O2|Outcome|Anti-Bovine Serum Albumin (Anti-BSA) Titer in Gelfoam Plus Sub|"Evaluation of anti-bovine serum albumin (anti-BSA) antibodies in subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
229867|NCT01458561|O1|Outcome|Anti-Bovine Serum Albumin (Anti-BSA) Titers in BioFoam Subj|"Evaluation of anti-bovine serum albumin (anti-BSA) antibodies in subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
229868|NCT01458561|O2|Outcome|# of Gelfoam Plus Subj. Requiring Hospitalization/Intervention|"Number of subjects receiving Gelfoam Plus as a surgical adjunct that required hospitalization or intervention following final wound closure through the 2 year follow-up visit~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
229869|NCT01458561|O1|Outcome|# of BioFoam Subjects Requiring Hospitalization/Intervention|"Number of subjects receiving BioFoam Surgical Matrix as a surgical adjunct that required hospitalization or intervention following final wound closure through the 2 year follow-up visit~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
229870|NCT01458561|O2|Outcome|Length of Hospital Stay for Gelfoam Plus Subjects|"Length of hospital stay for subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
229871|NCT01458561|O1|Outcome|Length of Hospital Stay for BioFoam Surgical Matrix Subjects|"Length of hospital stay for subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
229872|NCT01458561|O2|Outcome|Core Body Temp of Gelfoam Plus During Hemostat Application|"Core body temp during prescribed topical hemostat application for subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
229873|NCT01458561|O1|Outcome|Core Body Temp of BioFoam Subjects During Hemostat Application|"Core body temp during prescribed topical hemostat application for subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
229874|NCT01458561|O2|Outcome|Total Time of Procedure for Gelfoam Plus Subjects|"Total time of procedure for subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
229875|NCT01458561|O1|Outcome|Total Time of Procedure for BioFoam Surgical Matrix Subjects|"Total time of procedure for subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
229876|NCT01458561|O2|Outcome|Gelfoam Plus Subj. Requiring Reop. Due to Bleeding/Bili. Leak|"Number of subjects requiring reoperation due to bleeding and/or biliary leakage in subjects who received Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
229877|NCT01458561|O1|Outcome|BioFoam Subj. Requiring Reop. Due to Bleeding/Biliary Leakage|"Number of subjects requiring reoperation due to bleeding and/or biliary leakage in subjects who received BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
229878|NCT01458561|O2|Outcome|Presence of Device Via MRI in Gelfoam Plus Subjects|"Evaluation for presence of device via magnetic resonance imaging (MRI) in subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
229879|NCT01458561|O1|Outcome|Presence of Device Via MRI in BioFoam Surgical Matrix Subjects|"Evaluation for presence of device via magnetic resonance imaging (MRI) in subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
229880|NCT01458561|O2|Outcome|Laboratory Evaluations for Gelfoam Plus Subjects Out of Range|"Number of out of range lab evaluations for subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
229881|NCT01458561|O1|Outcome|Laboratory Evaluations for BioFoam Subjects Out of Range|"Number of out of range lab evaluations for subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
229882|NCT01458561|O2|Outcome|Amt. of Intraop. Blood Products Rec'd by Gelfoam Plus Subjects|"Amount of blood products administered intraoperatively to subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
229883|NCT01458561|O1|Outcome|Amt. of Intraop. Blood Products Rec'd by BioFoam Subjects|"Amount of blood products administered intraoperatively to subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
229884|NCT01458561|O2|Outcome|Duration of Postoperative Drainage in Gelfoam Plus Subjects|"Duration of postoperative drainage in subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
229885|NCT01458561|O1|Outcome|Duration of Postoperative Drainage in BioFoam Subjects|"Duration of postoperative drainage in subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
229886|NCT01458561|O2|Outcome|Gelfoam Plus|"Control of bleeding using Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
229887|NCT01458561|O1|Outcome|BioFoam Surgical Matrix|"Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
229888|NCT01458561|O2|Outcome|Gelfoam Plus|"Control of bleeding using Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
229889|NCT01458561|O1|Outcome|BioFoam Surgical Matrix|"Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
229890|NCT01458561|O2|Outcome|Intraop. Blood Loss in Gelfoam Plus Subjects|"Amount of blood lost intraoperatively in subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
229891|NCT01458561|O1|Outcome|Intraop. Blood Loss in BioFoam Surgical Matrix Subjects|"Amount of blood lost intraoperatively in subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
229892|NCT01458561|O2|Outcome|Achievement of Immediate Hemostasis in Gelfoam Plus Subjects|"Number of subjects achieving immediate hemostasis (1 minute following application of hemostatic agent) in subjects/participants receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
229893|NCT01458561|O1|Outcome|Achieve Immediate Hemostasis in BioFoam Subjects/Participants|"Number of subjects achieving immediate hemostasis (1 minute following application of hemostatic agent) in subjects/participants receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
229894|NCT01458561|O2|Outcome|Subjects/Participants Receiving Gelfoam Plus|"Number of subjects achieving hemostasis (y/n) at predetermined time points (1, 3, 5, 7, 10 min) in subjects/participants receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
229895|NCT01458561|O1|Outcome|Subjects/Participants Receiving BioFoam|"Number of subjects achieving hemostasis (y/n) at predetermined time points (1, 3, 5, 7, 10 min) in subjects/participants receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
229896|NCT01458561|O2|Outcome|Control Bleeding in Gelfoam Plus Subjects/Participants|"Control of bleeding in subjects/participants who receive Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
229897|NCT01458561|O1|Outcome|Control Bleeding in BioFoam Subjects/Participants|"Control of bleeding in subjects/participants who receive BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
229898|NCT01458561|E2|Reported Event|Gelfoam Plus|"Control of bleeding using Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
229899|NCT01458561|E1|Reported Event|BioFoam Surgical Matrix|"Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
229900|NCT01458535|B7|Baseline|Total|Total of all reporting groups
229901|NCT01458535|B6|Baseline|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
229902|NCT01458535|B5|Baseline|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
229903|NCT01458535|B4|Baseline|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
229904|NCT01458535|B3|Baseline|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
229905|NCT01458535|B2|Baseline|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
229906|NCT01458535|B1|Baseline|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
229907|NCT01458535|P6|Participant Flow|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
229908|NCT01458535|P5|Participant Flow|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
229909|NCT01458535|P4|Participant Flow|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
229910|NCT01458535|P3|Participant Flow|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
229911|NCT01458535|P2|Participant Flow|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
229912|NCT01458535|P1|Participant Flow|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided twice daily (BID) in treatment-naïve genotype 1 participants.
229913|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
229914|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
229915|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
261449|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
229916|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
229917|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
229918|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
229919|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
229920|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
229921|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
229922|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
229923|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
229924|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
229925|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
229926|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
229927|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
229928|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
229929|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
229930|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
229931|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
229932|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
229933|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
229934|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
229935|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
229936|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
229937|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
229938|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
229939|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
229940|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
229941|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
229942|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
229943|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
229944|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
229945|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
229946|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
229947|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
229948|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
229949|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
229950|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
229951|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
229952|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
229953|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
229954|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
229955|NCT01458535|E6|Reported Event|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 3 infection.
229956|NCT01458535|E5|Reported Event|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 2 infection.
229957|NCT01458535|E4|Reported Event|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 1 infection.
229958|NCT01458535|E3|Reported Event|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 3 infection.
229959|NCT01458535|E2|Reported Event|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 2 infection.
229960|NCT01458535|E1|Reported Event|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided twice daily (BID) in treatment-naïve participants with HCV genotype 1 infection.
229961|NCT01458392|B4|Baseline|Total|Total of all reporting groups
229962|NCT01458392|B3|Baseline|Dalantercept 1.2 mg/kg|Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
229963|NCT01458392|B2|Baseline|Dalantercept 0.6 mg/kg|Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
229964|NCT01458392|B1|Baseline|Dalantercept 80 mg|Subcutaneous 80 mg dose of dalantercept once every 3 weeks.
229965|NCT01458392|P3|Participant Flow|Dalantercept 1.2 mg/kg|Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
229966|NCT01458392|P2|Participant Flow|Dalantercept 0.6 mg/kg|Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
229967|NCT01458392|P1|Participant Flow|Dalantercept 80 mg|Subcutaneous 80 mg dose of dalantercept once every 3 weeks.
229968|NCT01458392|O2|Outcome|Dalantercept 1.2 mg/kg|Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
229969|NCT01458392|O1|Outcome|Dalantercept 0.6 mg/kg|Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
229970|NCT01458392|O2|Outcome|Dalantercept 1.2 mg/kg|Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
229971|NCT01458392|O1|Outcome|Dalantercept 0.6 mg/kg|Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
229972|NCT01458392|O2|Outcome|Dalantercept 1.2 mg/kg|Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
229973|NCT01458392|O1|Outcome|Dalantercept 0.6 mg/kg|Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
229974|NCT01458392|O2|Outcome|Dalantercept 1.2 mg/kg|Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
229975|NCT01458392|O1|Outcome|Dalantercept 0.6 mg/kg|Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
229976|NCT01458392|O2|Outcome|Dalantercept 1.2 mg/kg|Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
229977|NCT01458392|O1|Outcome|Dalantercept 0.6 mg/kg|Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
229978|NCT01458392|O3|Outcome|Dalantercept 1.2 mg/kg|Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
229979|NCT01458392|O2|Outcome|Dalantercept 0.6 mg/kg|Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
229980|NCT01458392|O1|Outcome|Dalantercept 80 mg|Subcutaneous 80 mg dose of dalantercept once every 3 weeks.
229981|NCT01458392|O2|Outcome|Dalantercept 1.2 mg/kg|Subcutaneous 1.2-mg/kg dose of dalantercept once every 3 weeks.
229982|NCT01458392|O1|Outcome|Dalantercept 0.6 mg/kg|Subcutaneous 0.6-mg/kg dose of dalantercept once every 3 weeks.
229983|NCT01458392|E3|Reported Event|Dalantercept 1.2 mg/kg|Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
229984|NCT01458392|E2|Reported Event|Dalantercept 0.6 mg/kg|Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
229985|NCT01458392|E1|Reported Event|Dalantercept 80 mg|Subcutaneous 80 mg dose of dalantercept once every 3 weeks.
229986|NCT01458288|B1|Baseline|TG-0054 (3.14 mg/kg Administrated Via 15-min IV Infusion)|"TG-0054 (3.14 mg/kg)~TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)"
229987|NCT01458288|P1|Participant Flow|TG-0054 (3.14 mg/kg TG-0054 Administrated Via 15-min IV Infus)|"TG-0054 (3.14 mg/kg)~TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)"
229988|NCT01458288|O2|Outcome|TG-0054 (3.14 mg/kg)+G-CSF|Patients followed administration of TG-0054 (3.14 mg/kg) combined with granulocyte colony-stimulating factor (G-CSF) and leukapheresis start from study day 8.
229989|NCT01458288|O1|Outcome|TG-0054 (3.14 mg/kg)|Patients followed administration of TG-0054 (3.14 mg/kg) alone and leukapheresis start from study day 1.
229990|NCT01458288|O2|Outcome|TG-0054 (3.14 mg/kg)+G-CSF|Patients followed administration of TG-0054 (3.14 mg/kg) combined with granulocyte colony-stimulating factor (G-CSF) and leukapheresis start from study day 8.
230516|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
229991|NCT01458288|O1|Outcome|TG-0054 (3.14 mg/kg)|Patients followed administration of TG-0054 (3.14 mg/kg) alone and leukapheresis start from study day 1.
229992|NCT01458288|O2|Outcome|TG-0054 (3.14 mg/kg)+G-CSF|Patients followed administration of TG-0054 (3.14 mg/kg) combined with granulocyte colony-stimulating factor (G-CSF) and leukapheresis start from study day 8.
229993|NCT01458288|O1|Outcome|TG-0054 (3.14 mg/kg)|Patients followed administration of TG-0054 (3.14 mg/kg) alone and leukapheresis start from study day 1.
229994|NCT01458288|E1|Reported Event|TG-0054 (3.14 mg/kg Administrated Via 15-min IV Infusion)|"TG-0054 (3.14 mg/kg)~TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)"
229995|NCT01458275|B4|Baseline|Total|Total of all reporting groups
229996|NCT01458275|B3|Baseline|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
229997|NCT01458275|B2|Baseline|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
229998|NCT01458275|B1|Baseline|Placebo|Placebo: Placebo - one actuation per nostril
229999|NCT01458275|P3|Participant Flow|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
230000|NCT01458275|P2|Participant Flow|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
230001|NCT01458275|P1|Participant Flow|Placebo|Placebo: Placebo - one actuation per nostril
230002|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
230003|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
230004|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
230005|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
230006|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
230007|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
230008|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
230009|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
230010|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
230011|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
230012|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
230013|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
230014|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
230015|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
230016|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
230017|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
230018|NCT01458275|O1|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
230019|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
230020|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
230021|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
230022|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
230023|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
230024|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
230025|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
230026|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
230027|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
230028|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
230029|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
230030|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
230031|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
230032|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
230033|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
230034|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
230035|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
230037|NCT01458275|E3|Reported Event|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
230038|NCT01458275|E2|Reported Event|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
230039|NCT01458275|E1|Reported Event|Placebo|Placebo: Placebo - one actuation per nostril
230040|NCT01458249|B3|Baseline|Total|Total of all reporting groups
230041|NCT01458249|B2|Baseline|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
230042|NCT01458249|B1|Baseline|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
230043|NCT01458249|P1|Participant Flow|All Treated Participants (Arm 1 and Arm 2)|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks).
230044|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
230045|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
230046|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
230047|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
230048|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
230049|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
230050|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
230051|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
230052|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
230053|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
230054|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
230055|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
230056|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
230057|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
230058|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
230059|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
230060|NCT01458249|E1|Reported Event|All Treated Participants (Arm 1 and Arm 2)|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks).
230061|NCT01458210|B1|Baseline|Overall Study|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively).~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
230062|NCT01458210|P1|Participant Flow|Overall Study|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively).~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
230063|NCT01458210|O2|Outcome|Ortho-Cyclen + Dulaglutide (Period 2)|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 2 sample was taken during the second 28-day course.~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
230064|NCT01458210|O1|Outcome|Ortho-Cyclen Alone (Period 1)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course.
230065|NCT01458210|O2|Outcome|Ortho-Cyclen + Dulaglutide (Period 2)|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 2 sample was taken during the second 28-day course.~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
230066|NCT01458210|O1|Outcome|Ortho-Cyclen Alone (Period 1)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course.
230067|NCT01458210|O2|Outcome|Ortho-Cyclen + Dulaglutide (Period 2)|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 2 sample was taken during the second 28-day course.~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
230068|NCT01458210|O1|Outcome|Ortho-Cyclen Alone (Period 1)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course.
230069|NCT01458210|O2|Outcome|Ortho-Cyclen + Dulaglutide (Period 2)|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 2 sample was taken during the second 28-day course.~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
230070|NCT01458210|O1|Outcome|Ortho-Cyclen Alone (Period 1)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course.
230071|NCT01458210|O2|Outcome|Ortho-Cyclen + Dulaglutide (Period 2)|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 2 sample was taken during the second 28-day course.~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
230072|NCT01458210|O1|Outcome|Ortho-Cyclen Alone (Period 1)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course.
230228|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
230073|NCT01458210|O2|Outcome|Ortho-Cyclen + Dulaglutide (Period 2)|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 2 sample was taken during the second 28-day course.~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
230074|NCT01458210|O1|Outcome|Ortho-Cyclen Alone (Period 1)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course.
230075|NCT01458210|E3|Reported Event|Ortho-Cyclen + Dulaglutide|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively).~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
230076|NCT01458210|E2|Reported Event|Ortho-Cyclen Alone|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively).
230077|NCT01458210|E1|Reported Event|Lead-in (1st Course of Ortho-Cyclen)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in).
230078|NCT01458171|B1|Baseline|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
230079|NCT01458171|P1|Participant Flow|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
230080|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
230081|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
230082|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
230083|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
230084|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
230085|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
230086|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
230087|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
230088|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
230089|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
230090|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
230091|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
230092|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
230093|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
230094|NCT01458171|O1|Outcome|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
230095|NCT01458171|O1|Outcome|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
230096|NCT01458171|O1|Outcome|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
261450|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
230097|NCT01458171|O1|Outcome|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
230098|NCT01458171|E1|Reported Event|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
230099|NCT01458106|B3|Baseline|Total|Total of all reporting groups
230100|NCT01458106|B2|Baseline|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
230101|NCT01458106|B1|Baseline|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
230102|NCT01458106|P2|Participant Flow|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
230103|NCT01458106|P1|Participant Flow|Participants < 6 Years Old|"Pharmacokinetic (PK) subgroup: After a Washout Period of ≥72 hrs, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5±2 minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for PK assessment. Following a second Washout Period of ≥72 hrs, participants receive a single IV injection of rFVIIIFc over 5±2 mins at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
230104|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230105|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230106|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230229|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
261451|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
230107|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230108|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230109|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230110|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230111|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230112|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230113|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230114|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230115|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230116|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230117|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230118|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230119|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230120|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230121|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230122|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230123|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230124|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230125|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230126|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230127|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230128|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230129|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230130|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230131|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230132|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230133|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230134|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230135|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230136|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230137|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230138|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230139|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230140|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230141|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230142|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230143|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230144|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230145|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230146|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230147|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230148|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230149|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230150|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230151|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230152|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230153|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230154|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230155|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
230181|NCT01457950|P3|Participant Flow|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230517|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
230156|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
230157|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
230158|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
230159|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
230160|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
230161|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
230162|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
230182|NCT01457950|P2|Participant Flow|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
230518|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230163|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
230164|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
230165|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
230166|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
230167|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
230168|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
230169|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
230183|NCT01457950|P1|Participant Flow|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
232807|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
230170|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
230171|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
230172|NCT01458106|O3|Outcome|All Arms: Total|
230173|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
230174|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
230175|NCT01458106|E2|Reported Event|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥ 72 hours, at the Baseline Visit (28 ± 7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (± 2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥ 72 hours, participants receive a single IV injection of rFVIIIFc over 5 (± 2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
230176|NCT01458106|E1|Reported Event|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥ 72 hours, at the Baseline Visit (28 ± 7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (± 2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥ 72 hours, participants receive a single IV injection of rFVIIIFc over 5 (± 2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
230177|NCT01457950|B3|Baseline|Total|Total of all reporting groups
230178|NCT01457950|B2|Baseline|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
230179|NCT01457950|B1|Baseline|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
230180|NCT01457950|P4|Participant Flow|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
232808|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
230184|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230185|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230186|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230187|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230188|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230189|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230190|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230191|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230192|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230193|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230194|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230195|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230196|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230197|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230198|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230199|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230200|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230201|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230202|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230203|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230204|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230205|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230206|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230207|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230208|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230227|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
230519|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
261452|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
230209|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230210|NCT01457950|O1|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230211|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230212|NCT01457950|O1|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230213|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230214|NCT01457950|O1|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230215|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230216|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
230217|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
230218|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
230219|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
230220|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
230221|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
230222|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
230223|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
230224|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
230225|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
230226|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
230230|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
230231|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
230232|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
230233|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
230234|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
230235|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
230236|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
230237|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
230238|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
230239|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
230240|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
230241|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
230242|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
230243|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
230244|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
230245|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
230246|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
230247|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
230248|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
230249|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
230250|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
230251|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
230252|NCT01457950|E4|Reported Event|Open Label Denosumab 60 mg (Previously Randomized Placebo)|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230520|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230253|NCT01457950|E3|Reported Event|Open Label Denosumab 60 mg (Previously Randomized Denosumab)|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
230254|NCT01457950|E2|Reported Event|Randomized Phase: Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
230255|NCT01457950|E1|Reported Event|Randomized Phase: Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
230256|NCT01457924|B6|Baseline|Total|Total of all reporting groups
230257|NCT01457924|B5|Baseline|Ofatumumab 60mg q4w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230258|NCT01457924|B4|Baseline|Ofatumumab 60 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230259|NCT01457924|B3|Baseline|Ofatumumab 30 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230260|NCT01457924|B2|Baseline|Ofatumumab 3 mg q12w|Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230261|NCT01457924|B1|Baseline|Placebo/Ofatumumab 3 mg|Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230262|NCT01457924|P5|Participant Flow|Ofatumumab 60mg q4w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230263|NCT01457924|P4|Participant Flow|Ofatumumab 60 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230264|NCT01457924|P3|Participant Flow|Ofatumumab 30 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230265|NCT01457924|P2|Participant Flow|Ofatumumab 3 mg q12w|Par. received ofatumumab 3 mg SC injection every 12th week (q12w) on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230266|NCT01457924|P1|Participant Flow|Placebo/Ofatumumab 3 mg|Par. received ofatumumab matching placebo subcutaneous (SC) injection every 4 weeks (q4w) from Week 0 to Week 20, except on Week 12 participants received 3 milligrams (mg) ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 gram (g) and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230267|NCT01457924|O5|Outcome|Ofatumumab 60mg q4w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230268|NCT01457924|O4|Outcome|Ofatumumab 60 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230269|NCT01457924|O3|Outcome|Ofatumumab 30 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230270|NCT01457924|O2|Outcome|Ofatumumab 3 mg q12w|Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230521|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
230271|NCT01457924|O1|Outcome|Placebo/Ofatumumab 3 mg|Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230272|NCT01457924|O5|Outcome|Ofatumumab 60mg q4w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230273|NCT01457924|O4|Outcome|Ofatumumab 60 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230274|NCT01457924|O3|Outcome|Ofatumumab 30 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230275|NCT01457924|O2|Outcome|Ofatumumab 3 mg q12w|Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230276|NCT01457924|O1|Outcome|Placebo/Ofatumumab 3 mg|Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230277|NCT01457924|O5|Outcome|Ofatumumab 60mg q4w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230278|NCT01457924|O4|Outcome|Ofatumumab 60 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230279|NCT01457924|O3|Outcome|Ofatumumab 30 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230280|NCT01457924|O2|Outcome|Ofatumumab 3 mg q12w|Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230281|NCT01457924|O1|Outcome|Placebo/Ofatumumab 3 mg|Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230282|NCT01457924|O5|Outcome|Ofatumumab 60mg q4w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230283|NCT01457924|O4|Outcome|Ofatumumab 60 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230284|NCT01457924|O3|Outcome|Ofatumumab 30 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230285|NCT01457924|O2|Outcome|Ofatumumab 3 mg q12w|Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230286|NCT01457924|O1|Outcome|Placebo/Ofatumumab 3 mg|Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230287|NCT01457924|O5|Outcome|Ofatumumab 60mg q4w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230288|NCT01457924|O4|Outcome|Ofatumumab 60 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230289|NCT01457924|O3|Outcome|Ofatumumab 30 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230290|NCT01457924|O2|Outcome|Ofatumumab 3 mg q12w|Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230291|NCT01457924|O1|Outcome|Placebo/Ofatumumab 3 mg|Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230292|NCT01457924|O5|Outcome|Ofatumumab 60mg q4w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230293|NCT01457924|O4|Outcome|Ofatumumab 60 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230294|NCT01457924|O3|Outcome|Ofatumumab 30 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230295|NCT01457924|O2|Outcome|Ofatumumab 3 mg q12w|Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230296|NCT01457924|O1|Outcome|Placebo/Ofatumumab 3 mg|Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230297|NCT01457924|O5|Outcome|Ofatumumab 60mg q4w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230298|NCT01457924|O4|Outcome|Ofatumumab 60 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230299|NCT01457924|O3|Outcome|Ofatumumab 30 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230300|NCT01457924|O2|Outcome|Ofatumumab 3 mg q12w|Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230301|NCT01457924|O1|Outcome|Placebo/Ofatumumab 3 mg|Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230302|NCT01457924|O5|Outcome|Ofatumumab 60mg q4w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230303|NCT01457924|O4|Outcome|Ofatumumab 60 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230304|NCT01457924|O3|Outcome|Ofatumumab 30 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230305|NCT01457924|O2|Outcome|Ofatumumab 3 mg q12w|Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230306|NCT01457924|O1|Outcome|Placebo/Ofatumumab 3 mg|Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230307|NCT01457924|O5|Outcome|Ofatumumab 60mg q4w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230308|NCT01457924|O4|Outcome|Ofatumumab 60 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230309|NCT01457924|O3|Outcome|Ofatumumab 30 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230310|NCT01457924|O2|Outcome|Ofatumumab 3 mg q12w|Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230311|NCT01457924|O1|Outcome|Placebo/Ofatumumab 3 mg|Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230312|NCT01457924|O5|Outcome|Ofatumumab 60mg q4w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230313|NCT01457924|O4|Outcome|Ofatumumab 60 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230314|NCT01457924|O3|Outcome|Ofatumumab 30 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230315|NCT01457924|O2|Outcome|Ofatumumab 3 mg q12w|Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230316|NCT01457924|O1|Outcome|Placebo/Ofatumumab 3 mg|Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230317|NCT01457924|O5|Outcome|Ofatumumab 60mg q4w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230318|NCT01457924|O4|Outcome|Ofatumumab 60 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230319|NCT01457924|O3|Outcome|Ofatumumab 30 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230320|NCT01457924|O2|Outcome|Ofatumumab 3 mg q12w|Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230321|NCT01457924|O1|Outcome|Placebo/Ofatumumab 3 mg|Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230322|NCT01457924|E5|Reported Event|Ofatumumab 60mg q4w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230323|NCT01457924|E4|Reported Event|Ofatumumab 60 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230361|NCT01457703|O2|Outcome|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology"
230522|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230324|NCT01457924|E3|Reported Event|Ofatumumab 30 mg q12w|Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230325|NCT01457924|E2|Reported Event|Ofatumumab 3 mg q12w|Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230326|NCT01457924|E1|Reported Event|Placebo/Ofatumumab 3 mg|Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
230327|NCT01457885|B1|Baseline|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant~Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
230328|NCT01457885|P1|Participant Flow|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant~Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
230329|NCT01457885|O1|Outcome|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant~Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
230330|NCT01457885|O1|Outcome|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant~Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
230331|NCT01457885|O1|Outcome|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant~Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
230332|NCT01457885|E1|Reported Event|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant~Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
230333|NCT01457846|B3|Baseline|Total|Total of all reporting groups
230334|NCT01457846|B2|Baseline|AZD4547|80mg BD 2 weeks on/1 week off
230335|NCT01457846|B1|Baseline|Paclitaxel|80mg / m^2
230336|NCT01457846|P2|Participant Flow|Paclitaxel|80mg / m^2
230337|NCT01457846|P1|Participant Flow|AZD4547|80mg BD 2 weeks on/1 week off
230338|NCT01457846|O2|Outcome|Paclitaxel|80mg / m^2
230339|NCT01457846|O1|Outcome|AZD4547|80mg BD 2 weeks on/1 week off
230340|NCT01457846|O2|Outcome|Paclitaxel|80mg / m^2
230341|NCT01457846|O1|Outcome|AZD4547|80mg BD 2 weeks on/1 week off
230342|NCT01457846|O2|Outcome|Paclitaxel|80mg / m^2
230343|NCT01457846|O1|Outcome|AZD4547|80mg BD 2 weeks on/1 week off
230344|NCT01457846|O2|Outcome|Paclitaxel|80mg / m^2
230345|NCT01457846|O1|Outcome|AZD4547|80mg BD 2 weeks on/1 week off
230346|NCT01457846|O2|Outcome|Paclitaxel|80mg / m^2
230347|NCT01457846|O1|Outcome|AZD4547|80mg BD 2 weeks on/1 week off
230348|NCT01457846|E2|Reported Event|Paclitaxel|80mg / m^2
230349|NCT01457846|E1|Reported Event|AZD4547|80mg BD 2 weeks on/1 week off
230350|NCT01457703|B3|Baseline|Total|Total of all reporting groups
230351|NCT01457703|B2|Baseline|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
230352|NCT01457703|B1|Baseline|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
230353|NCT01457703|P2|Participant Flow|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
230354|NCT01457703|P1|Participant Flow|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
230355|NCT01457703|O2|Outcome|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology"
230356|NCT01457703|O1|Outcome|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology"
230357|NCT01457703|O2|Outcome|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
230358|NCT01457703|O1|Outcome|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
230359|NCT01457703|O2|Outcome|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology"
230360|NCT01457703|O1|Outcome|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology"
230499|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
230362|NCT01457703|O1|Outcome|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology"
230363|NCT01457703|O2|Outcome|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
230364|NCT01457703|O1|Outcome|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
230365|NCT01457703|E2|Reported Event|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
230366|NCT01457703|E1|Reported Event|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
230367|NCT01457573|B1|Baseline|All Study Participants|Men > 50 years old with urinary frequency symptoms, who entered study not taking any bladder related medications and on study took tamsulosin and solifenacin orally everyday throughout the study with follow-up assessments at Month 1/week 4, Month 2 week 8, and Month 3/week 12.
230368|NCT01457573|P1|Participant Flow|Single Arm (Tamsulosin and Solifenacin)|10 Men with lower urinary tract symptoms (LUTS), consistent with BPH, were screened in our urology clinics for participation in a clinical trial.
230369|NCT01457573|O1|Outcome|Baseline Characteristics|Men > 50 years old with symptomatic LUTS (IPSS > 8), PSA < 10, PVR < 150 mls and maximum urinary flow rate > 10 mls/sec could enter the trial.
230370|NCT01457573|O1|Outcome|Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg|"All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg and Solifenacin (Vesicare) 5 mg orally at the same time.~Solifenacin (Vesicare) 5 mg orally at the same time.: Drug: Tamsulosin 0.4 mg in combination with Solifenacin 5 mg~All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg and Solifenacin (Vesicare) 5 mg orally at the same time."
230371|NCT01457573|O1|Outcome|Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg|"All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg and Solifenacin (Vesicare) 5 mg orally at the same time.~Solifenacin (Vesicare) 5 mg orally at the same time.: Drug: Tamsulosin 0.4 mg in combination with Solifenacin 5 mg~All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg and Solifenacin (Vesicare) 5 mg orally at the same time."
230372|NCT01457573|O1|Outcome|Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg|"All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg and Solifenacin (Vesicare) 5 mg orally at the same time.~Solifenacin (Vesicare) 5 mg orally at the same time.: Drug: Tamsulosin 0.4 mg in combination with Solifenacin 5 mg~All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg and Solifenacin (Vesicare) 5 mg orally at the same time."
230373|NCT01457573|O1|Outcome|Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg|"All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg and Solifenacin (Vesicare) 5 mg orally at the same time.~Solifenacin (Vesicare) 5 mg orally at the same time.: Drug: Tamsulosin 0.4 mg in combination with Solifenacin 5 mg~All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg and Solifenacin (Vesicare) 5 mg orally at the same time."
230374|NCT01457573|O1|Outcome|Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg|"All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg and Solifenacin (Vesicare) 5 mg orally at the same time.~Solifenacin (Vesicare) 5 mg orally at the same time.: Drug: Tamsulosin 0.4 mg in combination with Solifenacin 5 mg~All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg and Solifenacin (Vesicare) 5 mg orally at the same time."
230375|NCT01457573|O1|Outcome|Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg|"All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg and Solifenacin (Vesicare) 5 mg orally at the same time.~Solifenacin (Vesicare) 5 mg orally at the same time.: Drug: Tamsulosin 0.4 mg in combination with Solifenacin 5 mg~All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg and Solifenacin (Vesicare) 5 mg orally at the same time."
230376|NCT01457573|O1|Outcome|Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg|"All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg and Solifenacin (Vesicare) 5 mg orally at the same time.~Solifenacin (Vesicare) 5 mg orally at the same time.: Drug: Tamsulosin 0.4 mg in combination with Solifenacin 5 mg~All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg and Solifenacin (Vesicare) 5 mg orally at the same time."
230377|NCT01457573|O1|Outcome|Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg|"All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg and Solifenacin (Vesicare) 5 mg orally at the same time.~Solifenacin (Vesicare) 5 mg orally at the same time.: Drug: Tamsulosin 0.4 mg in combination with Solifenacin 5 mg~All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg and Solifenacin (Vesicare) 5 mg orally at the same time."
230378|NCT01457573|O1|Outcome|Baseline Characteristics|Men > 50 years old with symptomatic LUTS (IPSS > 8), PSA < 10, PVR < 150 mls and maximum urinary flow rate > 10 mls/sec could enter the trial.
230379|NCT01457573|O1|Outcome|Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg|"All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg and Solifenacin (Vesicare) 5 mg orally at the same time.~Solifenacin (Vesicare) 5 mg orally at the same time.: Drug: Tamsulosin 0.4 mg in combination with Solifenacin 5 mg~All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg and Solifenacin (Vesicare) 5 mg orally at the same time."
230380|NCT01457573|E1|Reported Event|Participant Flow|10 Men with lower urinary tract symptoms (LUTS), consistent with BPH, were screened in our urology clinics for participation in a clinical trial.
230381|NCT01457521|B3|Baseline|Total|Total of all reporting groups
230382|NCT01457521|B2|Baseline|Therapeutic|Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period.
230383|NCT01457521|B1|Baseline|Prophylactic|Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period.
230384|NCT01457521|P2|Participant Flow|Therapeutic|Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period.
230500|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230385|NCT01457521|P1|Participant Flow|Prophylactic|Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period.
230386|NCT01457521|O2|Outcome|Therapeutic|Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period.
230387|NCT01457521|O1|Outcome|Prophylactic|Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period.
230388|NCT01457521|E2|Reported Event|Therapeutic|Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period.
230389|NCT01457521|E1|Reported Event|Prophylactic|Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period.
230390|NCT01457430|B1|Baseline|Icatibant|Icatibant: 30 mg subcutaneous dose of Icatibant
230391|NCT01457430|P1|Participant Flow|Icatibant|Icatibant: 30 mg subcutaneous dose of Icatibant
230392|NCT01457430|O2|Outcome|Icatibant Treatment by Self Administration|Icatibant: 30 mg subcutaneous dose of Icatibant given to treat an acute attack of HAE by self administration.
230393|NCT01457430|O1|Outcome|Icatibant Treatment With Health Care Provider|Icatibant: 30 mg subcutaneous dose of Icatibant given to treat an acute attack of HAE by a health care provider.
230394|NCT01457430|O2|Outcome|Icatibant Treatment by Self Administration|Icatibant: 30 mg subcutaneous dose of Icatibant given to treat an acute attack of HAE by self administration.
230395|NCT01457430|O1|Outcome|Icatibant Treatment With Health Care Provider|Icatibant: 30 mg subcutaneous dose of Icatibant given to treat an acute attack of HAE by a health care provider.
230396|NCT01457430|E1|Reported Event|Icatibant|"Open-label study~Icatibant: 30 mg subcutaneous dose of Icatibant"
230397|NCT01457417|B6|Baseline|Total|Total of all reporting groups
230398|NCT01457417|B5|Baseline|300 mg DKN-01 Part B|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
230399|NCT01457417|B4|Baseline|600 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230400|NCT01457417|B3|Baseline|300 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230401|NCT01457417|B2|Baseline|150 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
230402|NCT01457417|B1|Baseline|75 Milligram (mg) DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230403|NCT01457417|P5|Participant Flow|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
230404|NCT01457417|P4|Participant Flow|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230501|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
230502|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230503|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
230504|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230405|NCT01457417|P3|Participant Flow|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230406|NCT01457417|P2|Participant Flow|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
230407|NCT01457417|P1|Participant Flow|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230408|NCT01457417|O1|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
230409|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
230410|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230411|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230412|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
230413|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230414|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
230415|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230505|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
230416|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230417|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
230418|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230419|NCT01457417|O1|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
230420|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
230421|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230422|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230423|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
230424|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230425|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
230426|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230506|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
232809|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
230427|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230428|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
230429|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230430|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
230431|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230432|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230433|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
230434|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230435|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
230436|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230507|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
230508|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230509|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
230437|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230438|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
230439|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230440|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
230441|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230442|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230443|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
230444|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230445|NCT01457417|O6|Outcome|Total|Total across all treatment groups
230446|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
230447|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230510|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230511|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
230512|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230448|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230449|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
230450|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230451|NCT01457417|O6|Outcome|Total|Total across all treatment groups
230452|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
230453|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230454|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230455|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
230456|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230457|NCT01457417|E5|Reported Event|300 mg DKN-01 Part B|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
230458|NCT01457417|E4|Reported Event|600 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230513|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
230514|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
232810|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
230459|NCT01457417|E3|Reported Event|300 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230460|NCT01457417|E2|Reported Event|150 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
230461|NCT01457417|E1|Reported Event|75 Milligram (mg) DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
230462|NCT01457339|B3|Baseline|Total|Total of all reporting groups
230463|NCT01457339|B2|Baseline|SPD489 (Lisdexamfetamine Dimesylate)(All Doses)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
230464|NCT01457339|B1|Baseline|Placebo|Placebo Capsule(s) for oral use taken once daily for 30 days
230465|NCT01457339|P2|Participant Flow|SPD489 (Lisdexamfetamine Dimesylate)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
230466|NCT01457339|P1|Participant Flow|Placebo|Placebo Capsule(s) for oral use taken once daily for 30 days
230467|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
230468|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230469|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
230470|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230471|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
230472|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230473|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
230474|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230475|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
230476|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230477|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
230478|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230479|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
230480|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230481|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
230482|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230483|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
230484|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230485|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
230486|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230487|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
230488|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230489|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
230490|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230491|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
230492|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230493|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
230494|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230495|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
230496|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230497|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
230498|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230523|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
230524|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230525|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
230526|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230527|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
230528|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230529|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
230530|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230531|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
230532|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230533|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
230534|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230535|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
230536|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230537|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
230538|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230539|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
230540|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230541|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
230542|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230543|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
230544|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230545|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
230546|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230547|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
230548|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230549|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
230550|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230551|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
230552|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230553|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
230554|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230555|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
230556|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230557|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
230558|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230559|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
230560|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230561|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
230562|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230563|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
230564|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230565|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
230566|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230567|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
230568|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230569|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
230570|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230571|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
230572|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230573|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
230574|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230575|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
230576|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
230577|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
230578|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
230579|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
230580|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230581|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
230582|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230583|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
230584|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230585|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
230586|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230587|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
230588|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230589|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
230590|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230591|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
230592|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230593|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
230594|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230595|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
230596|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230597|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
230598|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230599|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
230600|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230601|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
230602|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230603|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
230604|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230605|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
230606|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230607|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
230608|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230609|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
230610|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
230611|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
230612|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
230613|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
230614|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
230615|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
230616|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
230617|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
230618|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230619|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
230620|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230621|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
230622|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
230623|NCT01457339|E8|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(All Doses)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
230624|NCT01457339|E7|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
230625|NCT01457339|E6|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
230626|NCT01457339|E5|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
230627|NCT01457339|E4|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
230628|NCT01457339|E3|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
230629|NCT01457339|E2|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
230630|NCT01457339|E1|Reported Event|Placebo|Placebo Capsule(s) for oral use taken once daily for 30 days
230631|NCT01457053|B1|Baseline|All Study Participants|2 subjects completed the study. 2 subjects did not complete either arm and did not have usable data.
230632|NCT01457053|P2|Participant Flow|Diuretic Therapy|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretic therapy. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.~Loop diuretics (furosemide, torsemide, bumetanide): Patients with ADHF and hypervolemia will be enrolled in a prospective, randomized fashion.~Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization for the management of fluid overload.~Patients randomized to diuretic therapy will be treated with intravenous loop diuretics (e.g. furosemide, bumetanide, torsemide). The selection of diuretic, dose and frequency of diuretic administration will be determined by the treating physicians based upon clinical assessment of volume status, response to medication, and perceived safety."
230633|NCT01457053|P1|Participant Flow|Ultrafiltration|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretics. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.~Ultrafiltration: Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization or outpatient heart failure clinic for the management of fluid overload. If randomized to the ultrafiltration arm, on admission to the hospital patients will be initiated on ultrafiltration therapy for 2-5 days.~Patients randomized to UF will be treated using the Aquadex System 100 ultrafiltration device (CHF Solutions, Minneapolis, MN). The selection of ultrafiltration rate (fluid removal rate)will be determined by the treating physicians based upon clinical assessment of volume status and perceived safety."
230634|NCT01457053|O2|Outcome|Diuretic Therapy|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretic therapy. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.~Loop diuretics (furosemide, torsemide, bumetanide): Patients with ADHF and hypervolemia will be enrolled in a prospective, randomized fashion.~Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization for the management of fluid overload.~Patients randomized to diuretic therapy will be treated with intravenous loop diuretics (e.g. furosemide, bumetanide, torsemide). The selection of diuretic, dose and frequency of diuretic administration will be determined by the treating physicians based upon clinical assessment of volume status, response to medication, and perceived safety."
230635|NCT01457053|O1|Outcome|Ultrafiltration|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretics. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.~Ultrafiltration: Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization or outpatient heart failure clinic for the management of fluid overload. If randomized to the ultrafiltration arm, on admission to the hospital patients will be initiated on ultrafiltration therapy for 2-5 days.~Patients randomized to UF will be treated using the Aquadex System 100 ultrafiltration device (CHF Solutions, Minneapolis, MN). The selection of ultrafiltration rate (fluid removal rate)will be determined by the treating physicians based upon clinical assessment of volume status and perceived safety."
230636|NCT01457053|E2|Reported Event|Diuretic Therapy|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretic therapy. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.~Loop diuretics (furosemide, torsemide, bumetanide): Patients with ADHF and hypervolemia will be enrolled in a prospective, randomized fashion.~Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization for the management of fluid overload.~Patients randomized to diuretic therapy will be treated with intravenous loop diuretics (e.g. furosemide, bumetanide, torsemide). The selection of diuretic, dose and frequency of diuretic administration will be determined by the treating physicians based upon clinical assessment of volume status, response to medication, and perceived safety."
230637|NCT01457053|E1|Reported Event|Ultrafiltration|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretics. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.~Ultrafiltration: Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization or outpatient heart failure clinic for the management of fluid overload. If randomized to the ultrafiltration arm, on admission to the hospital patients will be initiated on ultrafiltration therapy for 2-5 days.~Patients randomized to UF will be treated using the Aquadex System 100 ultrafiltration device (CHF Solutions, Minneapolis, MN). The selection of ultrafiltration rate (fluid removal rate)will be determined by the treating physicians based upon clinical assessment of volume status and perceived safety."
230638|NCT01457014|B1|Baseline|Total Group|34 subjects completed part 1 of the study which consisted of diagnostic PSG screening and met all inclusion/exclusion criteria
230639|NCT01457014|P4|Participant Flow|Servo Ventilation Manual (Manual SV)|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference.~servo ventilation manual: servo ventilation titrated in manual mode"
230640|NCT01457014|P3|Participant Flow|Servo Ventilation Auto Mode (autoSV)|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device.~servo ventilation auto: Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
230641|NCT01457014|P2|Participant Flow|Continuous Positive Airway Pressure (CPAP)|"Airway pressure delivered at a constant pressure level.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
230642|NCT01457014|P1|Participant Flow|Diagnostic Polysomnography (PSG)|A Diagnostic PSG was performed using the core equipment available to determine eligibility into the overnight portion of the study.
230643|NCT01457014|O4|Outcome|Servo Ventilation Manual|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference.~servo ventilation manual: servo ventilation titrated in manual mode"
230644|NCT01457014|O3|Outcome|Servo Ventilation Auto Mode|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device.~servo ventilation auto: Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
230645|NCT01457014|O2|Outcome|CPAP|"Airway pressure delivered at a constant pressure level.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
230646|NCT01457014|O1|Outcome|Diagnostic PSG|Baseline overnight PSG.
230647|NCT01457014|O4|Outcome|Servo Ventilation Manual|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference.~servo ventilation manual: servo ventilation titrated in manual mode"
230648|NCT01457014|O3|Outcome|Servo Ventilation Auto Mode|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device.~servo ventilation auto: Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
230649|NCT01457014|O2|Outcome|CPAP|"Airway pressure delivered at a constant pressure level.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
230650|NCT01457014|O1|Outcome|Diagnostic PSG|Baseline overnight PSG.
230651|NCT01457014|O4|Outcome|Servo Ventilation Manual|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference.~servo ventilation manual: servo ventilation titrated in manual mode"
230652|NCT01457014|O3|Outcome|Servo Ventilation Auto Mode|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device.~servo ventilation auto: Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
230653|NCT01457014|O2|Outcome|CPAP|"Airway pressure delivered at a constant pressure level.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
230654|NCT01457014|O1|Outcome|Diagnostic Polysomnography (PSG)|Baseline overnight Polysomnography (PSG)
230655|NCT01457014|E1|Reported Event|Total Group|34 subjects completed part 1 of the study which consisted of diagnostic PSG screening and met all inclusion/exclusion criteria
230656|NCT01456962|B3|Baseline|Total|Total of all reporting groups
230657|NCT01456962|B2|Baseline|Atazanavir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with ritonavir (RIT)-boosted atazanavir (ATZ) with a CD4+ T-cells/mm3 >300 and HIV RNA copies/mL <48 for a minimum of 6 months.
230658|NCT01456962|B1|Baseline|Raltegravir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with raltegravir (RAL) with a CD4+ T-cells/mm3 >300 and HIV RNA copies/mL <48 for a minimum of 6 months.
230659|NCT01456962|P2|Participant Flow|Atazanavir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with ritonavir (RIT)-boosted atazanavir (ATZ) with a CD4+ T-cells/mm3 >300 and HIV RNA copies/mL <48 for a minimum of 6 months.
230660|NCT01456962|P1|Participant Flow|Raltegravir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with raltegravir (RAL) with a CD4+ T-cells/mm3 >300 and HIV RNA copies/mL <48 for a minimum of 6 months.
230661|NCT01456962|O2|Outcome|Atazanavir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with ritonavir (RIT)-boosted atazanavir (ATZ)
230662|NCT01456962|O1|Outcome|Raltegravir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with raltegravir (RAL)
230663|NCT01456962|E2|Reported Event|Atazanavir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with ritonavir (RIT)-boosted atazanavir (ATZ)
230664|NCT01456962|E1|Reported Event|Raltegravir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with raltegravir (RAL)
230665|NCT01456936|B5|Baseline|Total|Total of all reporting groups
230666|NCT01456936|B4|Baseline|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230667|NCT01456936|B3|Baseline|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230668|NCT01456936|B2|Baseline|Bupropion|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230669|NCT01456936|B1|Baseline|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230670|NCT01456936|P4|Participant Flow|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230826|NCT01456195|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
230827|NCT01456195|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
230671|NCT01456936|P3|Participant Flow|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230672|NCT01456936|P2|Participant Flow|Bupropion|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230673|NCT01456936|P1|Participant Flow|Varenicline|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg daily once (QD) x 3 days, 0.5 mg twice daily (BID) x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230674|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230675|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230676|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230677|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230678|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230679|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230680|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230681|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230682|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230683|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230684|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230685|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230686|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230785|NCT01456780|O3|Outcome|Bausch & Lomb Lubricant Drops|"Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks.~Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks."
261453|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
230687|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230688|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230689|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230690|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230691|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230692|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230693|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230694|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230695|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230696|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230697|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230698|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230699|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230700|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230701|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230702|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230786|NCT01456780|O2|Outcome|Lotemax|"Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation.~Loteprednol: Eye drops, 1 drop twice a day for 4 weeks"
261454|NCT01355523|E2|Reported Event|Placebo|6 mg oral placebo daily
230703|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230704|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230705|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230706|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230707|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230708|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230709|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230710|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230711|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230712|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230713|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230714|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230715|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230716|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230717|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230718|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230787|NCT01456780|O1|Outcome|Zylet|"Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic.~Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks."
230719|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230720|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230721|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230722|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230723|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230724|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230725|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230726|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230727|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230728|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230729|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230730|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230731|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230732|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230733|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230734|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230788|NCT01456780|O3|Outcome|Bausch & Lomb Lubricant Drops|"Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks.~Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks."
232811|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
230735|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230736|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230737|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230738|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230739|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230740|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230741|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230742|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230743|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230744|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230745|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230746|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230747|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230748|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230749|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230750|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230789|NCT01456780|O2|Outcome|Lotemax|"Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation.~Loteprednol: Eye drops, 1 drop twice a day for 4 weeks"
232812|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
230751|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230752|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230753|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230754|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230755|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230756|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230757|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230758|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230759|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230760|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230761|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230762|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230763|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230764|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230765|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230766|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230790|NCT01456780|O1|Outcome|Zylet|"Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic.~Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks."
230767|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230768|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230769|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230770|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230771|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230772|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230773|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230774|NCT01456936|E4|Reported Event|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
230775|NCT01456936|E3|Reported Event|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
230776|NCT01456936|E2|Reported Event|Bupropion|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
230777|NCT01456936|E1|Reported Event|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
230778|NCT01456780|B4|Baseline|Total|Total of all reporting groups
230779|NCT01456780|B3|Baseline|Bausch & Lomb Lubricant Drops|"Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks.~Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks."
230780|NCT01456780|B2|Baseline|Lotemax|"Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation.~Loteprednol: Eye drops, 1 drop twice a day for 4 weeks"
230781|NCT01456780|B1|Baseline|Zylet|"Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic.~Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks."
230782|NCT01456780|P3|Participant Flow|Bausch & Lomb Lubricant Drops|"Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks.~Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks."
230783|NCT01456780|P2|Participant Flow|Lotemax|"Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation.~Loteprednol: Eye drops, 1 drop twice a day for 4 weeks"
230784|NCT01456780|P1|Participant Flow|Zylet|"Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic.~Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks."
232813|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
230791|NCT01456780|O3|Outcome|Bausch & Lomb Lubricant Drops|"Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks.~Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks."
230792|NCT01456780|O2|Outcome|Lotemax|"Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation.~Loteprednol: Eye drops, 1 drop twice a day for 4 weeks"
230793|NCT01456780|O1|Outcome|Zylet|"Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic.~Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks."
230794|NCT01456780|O3|Outcome|Bausch & Lomb Lubricant Drops|"Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks.~Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks."
230795|NCT01456780|O2|Outcome|Lotemax|"Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation.~Loteprednol: Eye drops, 1 drop twice a day for 4 weeks"
230796|NCT01456780|O1|Outcome|Zylet|"Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic.~Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks."
230797|NCT01456780|E3|Reported Event|Bausch & Lomb Lubricant Drops|"Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks.~Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks."
230798|NCT01456780|E2|Reported Event|Lotemax|"Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation (swelling).~Loteprednol: Eye drops, 1 drop twice a day for 4 weeks"
230799|NCT01456780|E1|Reported Event|Zylet|"Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation (swelling). Tobramycin is an antibiotic.~Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks."
230800|NCT01456299|B4|Baseline|Total|Total of all reporting groups
230801|NCT01456299|B3|Baseline|Remifentanil 2|"The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml~remifentanil 2: Patients received no remifentanil"
230802|NCT01456299|B2|Baseline|Remifentanil 1|"The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml~control: Patients received a normal saline only"
230803|NCT01456299|B1|Baseline|Control|"The control group, which received an infusion of normal saline~remifentanil 1: The patients received an infusion of remifentanil"
230804|NCT01456299|P3|Participant Flow|Remifentanil 2|"The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml~remifentanil 2: Patients received no remifentanil"
230805|NCT01456299|P2|Participant Flow|Control|"The control group, which received an infusion of normal saline~remifentanil 1: The patients received an infusion of remifentanil"
230806|NCT01456299|P1|Participant Flow|Remifentanil 1|"The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml~control: Patients received a normal saline only"
230807|NCT01456299|O3|Outcome|Remifentanil 2|"The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml~remifentanil 2: Patients received no remifentanil"
230808|NCT01456299|O2|Outcome|Remifentanil 1|"The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml~control: Patients received a normal saline only"
230809|NCT01456299|O1|Outcome|Control|"The control group, which received an infusion of normal saline~remifentanil 1: The patients received an infusion of remifentanil"
230810|NCT01456299|E3|Reported Event|Remifentanil 2|"The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml~remifentanil 2: Patients received no remifentanil"
230811|NCT01456299|E2|Reported Event|Remifentanil 1|"The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml~control: Patients received a normal saline only"
230812|NCT01456299|E1|Reported Event|Control|"The control group, which received an infusion of normal saline~remifentanil 1: The patients received an infusion of remifentanil"
230813|NCT01456195|B4|Baseline|Total|Total of all reporting groups
230814|NCT01456195|B3|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
230815|NCT01456195|B2|Baseline|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
230816|NCT01456195|B1|Baseline|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
230817|NCT01456195|P3|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
230818|NCT01456195|P2|Participant Flow|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
230819|NCT01456195|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
230820|NCT01456195|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
230821|NCT01456195|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
230822|NCT01456195|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
230823|NCT01456195|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
230824|NCT01456195|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
230825|NCT01456195|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
232814|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
230828|NCT01456195|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
230829|NCT01456195|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
230830|NCT01456195|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
230831|NCT01456195|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
230832|NCT01456195|E3|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
230833|NCT01456195|E2|Reported Event|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
230834|NCT01456195|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
230835|NCT01456169|B4|Baseline|Total|Total of all reporting groups
230836|NCT01456169|B3|Baseline|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
230837|NCT01456169|B2|Baseline|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
230838|NCT01456169|B1|Baseline|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
230839|NCT01456169|P3|Participant Flow|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
230840|NCT01456169|P2|Participant Flow|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
230841|NCT01456169|P1|Participant Flow|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
230842|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
230843|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
230844|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
230845|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
230846|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
230847|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
230848|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
230849|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
230850|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
230851|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
230852|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
230853|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
230854|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
230855|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
230856|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
230857|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
230858|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
230859|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
230860|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
230861|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
230862|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
230863|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
230864|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
230865|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
230866|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
230867|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
230868|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
232815|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
230869|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
230870|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
230871|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
230872|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
230873|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
230874|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
230875|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
230876|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
230877|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
230878|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
230879|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
230880|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
230881|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
230882|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
230883|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
230884|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
230885|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
230886|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
230887|NCT01456169|E4|Reported Event|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks during the Double-Blind Treatment Period.
230888|NCT01456169|E3|Reported Event|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks during the Double-Blind Treatment Period.
230889|NCT01456169|E2|Reported Event|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks during the Double-Blind Treatment Period.
230890|NCT01456169|E1|Reported Event|Monotherapy: Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for 4 weeks during the Single-Blind Monotherapy Treatment Period. All enrolled participants, including those who were not randomized to double-blind treatment are included in this group.
230891|NCT01456143|B1|Baseline|HRME With Proflavine Hemisulfate|High Resolution Microendoscopy imaging device used in conjunction with proflavine hemisulfate as a contrast agent
230892|NCT01456143|P1|Participant Flow|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
230893|NCT01456143|O1|Outcome|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
230894|NCT01456143|O1|Outcome|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
230895|NCT01456143|O1|Outcome|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
230896|NCT01456143|O1|Outcome|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
230897|NCT01456143|O1|Outcome|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
232816|NCT01451411|E2|Reported Event|Placebo|Placebo: Intravenous
230898|NCT01456143|O1|Outcome|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
230899|NCT01456143|E1|Reported Event|HRME With Proflavine Hemisulfate|High Resolution Microendoscopy imaging device used in conjunction with proflavine hemisulfate as a contrast agent
230900|NCT01456130|B1|Baseline|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
230901|NCT01456130|P1|Participant Flow|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
230902|NCT01456130|O1|Outcome|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
230903|NCT01456130|O1|Outcome|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
230904|NCT01456130|O1|Outcome|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
230905|NCT01456130|O1|Outcome|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
230906|NCT01456130|E1|Reported Event|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
230907|NCT01456052|B4|Baseline|Total|Total of all reporting groups
230908|NCT01456052|B3|Baseline|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
230909|NCT01456052|B2|Baseline|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
230910|NCT01456052|B1|Baseline|Placebo|Placebo: Matching placebo administered orally
230911|NCT01456052|P3|Participant Flow|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
230912|NCT01456052|P2|Participant Flow|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
230913|NCT01456052|P1|Participant Flow|Placebo|Placebo: Matching placebo administered orally
230914|NCT01456052|O3|Outcome|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
230915|NCT01456052|O2|Outcome|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
230916|NCT01456052|O1|Outcome|Placebo|Placebo: Matching placebo administered orally
230917|NCT01456052|O3|Outcome|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
230918|NCT01456052|O2|Outcome|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
230919|NCT01456052|O1|Outcome|Placebo|Placebo: Matching placebo administered orally
230920|NCT01456052|O3|Outcome|Placebo|Placebo: Matching placebo administered orally
230921|NCT01456052|O2|Outcome|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
230922|NCT01456052|O1|Outcome|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
230923|NCT01456052|O3|Outcome|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
230924|NCT01456052|O2|Outcome|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
230925|NCT01456052|O1|Outcome|Placebo|Placebo: Matching placebo administered orally
230926|NCT01456052|E3|Reported Event|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
230927|NCT01456052|E2|Reported Event|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
230928|NCT01456052|E1|Reported Event|Placebo|Placebo: Matching placebo administered orally
230929|NCT01456039|B4|Baseline|Total|Total of all reporting groups
230930|NCT01456039|B3|Baseline|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230931|NCT01456039|B2|Baseline|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230932|NCT01456039|B1|Baseline|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
230933|NCT01456039|P3|Participant Flow|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230934|NCT01456039|P2|Participant Flow|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230935|NCT01456039|P1|Participant Flow|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
230936|NCT01456039|O4|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230937|NCT01456039|O3|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230938|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230939|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
230940|NCT01456039|O4|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230941|NCT01456039|O3|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230942|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
232817|NCT01451411|E1|Reported Event|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
230943|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
230944|NCT01456039|O3|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230945|NCT01456039|O2|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230946|NCT01456039|O1|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230947|NCT01456039|O3|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230948|NCT01456039|O2|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230949|NCT01456039|O1|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230950|NCT01456039|O3|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230951|NCT01456039|O2|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230952|NCT01456039|O1|Outcome|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230953|NCT01456039|O3|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230954|NCT01456039|O2|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230955|NCT01456039|O1|Outcome|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230956|NCT01456039|O4|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230957|NCT01456039|O3|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230958|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230959|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
230960|NCT01456039|O4|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230961|NCT01456039|O3|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230962|NCT01456039|O2|Outcome|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230963|NCT01456039|O1|Outcome|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
230964|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230965|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
230966|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230967|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
230968|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230969|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
230970|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230971|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
230972|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230973|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
230974|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230975|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
230976|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230977|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
230978|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230979|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
230980|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230981|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
230982|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230983|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
230984|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230985|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
230986|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230987|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
230988|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230989|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
230990|NCT01456039|O4|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230991|NCT01456039|O3|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230992|NCT01456039|O2|Outcome|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230993|NCT01456039|O1|Outcome|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
230994|NCT01456039|O4|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230995|NCT01456039|O3|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230996|NCT01456039|O2|Outcome|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230997|NCT01456039|O1|Outcome|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
230998|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
230999|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
231000|NCT01456039|E4|Reported Event|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
231001|NCT01456039|E3|Reported Event|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
231002|NCT01456039|E2|Reported Event|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
231003|NCT01456039|E1|Reported Event|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
231004|NCT01456000|B3|Baseline|Total|Total of all reporting groups
231005|NCT01456000|B2|Baseline|Control Arm Ablation|"Treatment with standard ablation. Randomized and treated cohort.~Control Arm Ablation: Treatment with standard radiofrequency (RF) ablation."
231006|NCT01456000|B1|Baseline|EAS-AC (HeartLight)|"Treatment with the EAS-AC. Randomized and treated cohort.~EAS-AC (HeartLight): Pulmonary vien isolation"
231007|NCT01456000|P2|Participant Flow|Control Arm Ablation|"Treatment with standard ablation.~Control Arm Ablation: Treatment with standard ablation.~ITT Population 175 Participants"
231008|NCT01456000|P1|Participant Flow|EAS-AC (HeartLight)|"Treatment with the EAS-AC.~EAS-AC (HeartLight): Pulmonary vien isolation~ITT Population 178 participants"
231009|NCT01456000|O2|Outcome|Control Arm Ablation|"Treatment with standard ablation and evaluable for efficacy.~Control Arm Ablation: Treatment with standard ablation."
231010|NCT01456000|O1|Outcome|EAS-AC (HeartLight)|"Treatment with the EAS-AC and evaluable for efficacy.~EAS-AC (HeartLight): Pulmonary vien isolation"
231011|NCT01456000|E2|Reported Event|Control Arm Ablation|"Treatment with standard ablation.~Control Arm Ablation: Treatment with standard ablation.~ITT Population 175 Participants"
231012|NCT01456000|E1|Reported Event|EAS-AC (HeartLight)|"Treatment with the EAS-AC.~EAS-AC (HeartLight): Pulmonary vien isolation~ITT Population 178 participants"
231013|NCT01455545|B1|Baseline|Asthmatic Patients|"Patient group with bad control defined as participants with an Asthma Control Test (ACT) score = or < 19. Patient group with good control defined as participants with an Asthma Control Test (ACT)score > 19.~In both groups there were patients with mild, moderate and severe asthma according the Global Initiative for Asthma (GINA)."
231014|NCT01455545|P2|Participant Flow|Good Control|Patient group with good control defined as participants with an Asthma Control Test (ACT)> 19 points.
231015|NCT01455545|P1|Participant Flow|Bad Control|Patient group with bad control defined as participants with an Asthma Control Test (ACT) = or < 19 points.
231016|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
231017|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
231018|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
231019|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
231020|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score > 19 .
231021|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test (ACT). Bad control if ACT score < or = 19 .
231022|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
231023|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
231024|NCT01455545|O2|Outcome|Good Control|Patients with asthma and goog control. Good control if ACT score > 19.
231025|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control. Bad control if ACT score < or = 19.
231026|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
231027|NCT01455545|O1|Outcome|Bad Control Asthmatic Patients|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
231028|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
231029|NCT01455545|O1|Outcome|Bad Control Asthmatic Patients|Patients with asthma and bad control evaluated by Asthma Control Test (ACT). Bad control if ACT score < or = 19.
231030|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19 .
231031|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19 .
231032|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19 .
231033|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
231034|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
231035|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19 .
231036|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score > 19.
231037|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test (ACT). Bad control if ACT score < or = 19 .
231038|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score > 19.
231039|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19 .
231040|NCT01455545|E2|Reported Event|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control more than 19 score.
231041|NCT01455545|E1|Reported Event|Bad Control Asthmatic Patients|Patients with asthma and bad control evaluated by Asthma Control Test. Good control less than 20 score.
231042|NCT01455519|B3|Baseline|Total|Total of all reporting groups
231043|NCT01455519|B2|Baseline|Hydromorphone ER|"Subjects received study drug: Hydromorphone ER~Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used."
231044|NCT01455519|B1|Baseline|Sugar Pill|Subjects may receive a pill with no medicine.
231045|NCT01455519|P2|Participant Flow|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
231046|NCT01455519|P1|Participant Flow|Sugar Pill|Subjects may receive a pill with no medicine.
231047|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
231048|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
231049|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
231050|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
231051|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
231052|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
231053|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
231054|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
231055|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
231056|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
231199|NCT01455194|P1|Participant Flow|Baseline Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, metered dose inhaler (MDI), inhalational, twice daily for up to 3 weeks in the baseline period.
231255|NCT01455064|B1|Baseline|Observational Group|Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours).
231057|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
231058|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
231059|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
231060|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
231061|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
231062|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
231063|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
231064|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
231065|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
231066|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
231067|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
231068|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
231069|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
231070|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
231071|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
231072|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
231073|NCT01455519|E2|Reported Event|Hydromorphone ER|"Subjects received study drug: Hydromorphone ER~Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used."
231074|NCT01455519|E1|Reported Event|Sugar Pill|Subjects may receive a pill with no medicine.
231075|NCT01455428|B3|Baseline|Total|Total of all reporting groups
231076|NCT01455428|B2|Baseline|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks.
231200|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231201|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231077|NCT01455428|B1|Baseline|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231078|NCT01455428|P2|Participant Flow|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks.
231079|NCT01455428|P1|Participant Flow|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231080|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
231081|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231082|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
231083|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231084|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
231085|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231086|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
231087|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231088|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
231089|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231090|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
231091|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231092|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
231093|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231094|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
231095|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231096|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
231097|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231098|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
231202|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231203|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231099|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231100|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
231101|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231102|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
231103|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231104|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
231105|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231106|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
231107|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231108|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
231109|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231110|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
231111|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231112|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
231113|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231114|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
231115|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231116|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
231117|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231118|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
231119|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231120|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
231204|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231205|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231121|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231122|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
231123|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231124|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
231125|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231126|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
231127|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231128|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
231129|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231130|NCT01455428|E2|Reported Event|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks.
231131|NCT01455428|E1|Reported Event|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
231132|NCT01455415|B3|Baseline|Total|Total of all reporting groups
231133|NCT01455415|B2|Baseline|Placebo/Pregablin|Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (150 - 300 mg/day). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231134|NCT01455415|B1|Baseline|Pregabalin/Placebo|Participants were randomized to double-blind treatment with pregabalin for 6 weeks (150 - 300 mg/day) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231135|NCT01455415|P2|Participant Flow|Placebo/Pregablin|Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (150 - 300 mg/day). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231136|NCT01455415|P1|Participant Flow|Pregabalin/Placebo|Participants were randomized to double-blind treatment with pregabalin for 6 weeks (150 - 300 mg/day) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231137|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231138|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231139|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231206|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231140|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231141|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231142|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231143|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231144|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231145|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231146|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231147|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231148|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231149|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231150|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231151|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231207|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231208|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231152|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231153|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231154|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231155|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231156|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231157|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231158|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231159|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231160|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231161|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231162|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231163|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231209|NCT01455194|O4|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231210|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231164|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231165|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231166|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231167|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231168|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231169|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231170|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231171|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231172|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231173|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231174|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231175|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231211|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231212|NCT01455194|O1|Outcome|Baseline Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 3 weeks in the baseline period.
231176|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231177|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231178|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231179|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231180|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231181|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231182|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231183|NCT01455415|E2|Reported Event|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231184|NCT01455415|E1|Reported Event|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
231185|NCT01455220|B1|Baseline|Tysabri|All patients were receiving commercial Tysabri
231186|NCT01455220|P1|Participant Flow|All Patients|
231187|NCT01455220|O1|Outcome|MSQOL-54 Total (Baseline to 6 Months)|
231188|NCT01455220|O1|Outcome|FAMS (Baseline to 6 Months)|
231189|NCT01455220|O1|Outcome|MSQOL-54, Physical (Baseline to 6 Months)|
231190|NCT01455220|O1|Outcome|Baseline to 6 Months (MSISQ-19 Scores)|All enrolled participants
231191|NCT01455220|E1|Reported Event|All Patients|no Adverse events were experienced
231192|NCT01455194|B4|Baseline|Total|Total of all reporting groups
231193|NCT01455194|B3|Baseline|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231194|NCT01455194|B2|Baseline|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231195|NCT01455194|B1|Baseline|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231196|NCT01455194|P4|Participant Flow|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231197|NCT01455194|P3|Participant Flow|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231198|NCT01455194|P2|Participant Flow|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, metered dose inhaler (MDI), inhalational, twice daily for up to 3 weeks in the baseline period. Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231254|NCT01455181|E1|Reported Event|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
231213|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231214|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231215|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231216|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231217|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231218|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231219|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231220|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231221|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231222|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231223|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231224|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231225|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231226|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231227|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231228|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231229|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231230|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231231|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231232|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231233|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231234|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231235|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231236|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231237|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231238|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231239|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231240|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231241|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231242|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231243|NCT01455194|E4|Reported Event|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231244|NCT01455194|E3|Reported Event|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231245|NCT01455194|E2|Reported Event|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
231246|NCT01455194|E1|Reported Event|Baseline Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 3 weeks in the baseline period.
231247|NCT01455181|B1|Baseline|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
231248|NCT01455181|P1|Participant Flow|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
231249|NCT01455181|O1|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
231250|NCT01455181|O1|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
231251|NCT01455181|O1|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
231252|NCT01455181|O1|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
231253|NCT01455181|O1|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
231256|NCT01455064|P1|Participant Flow|Observational Group|Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours).
231257|NCT01455064|O1|Outcome|Observational Group|Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours).
231258|NCT01455064|E1|Reported Event|Observational Group|Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours).
231259|NCT01455012|B3|Baseline|Total|Total of all reporting groups
231260|NCT01455012|B2|Baseline|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231261|NCT01455012|B1|Baseline|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231262|NCT01455012|P2|Participant Flow|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231263|NCT01455012|P1|Participant Flow|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231264|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231265|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231266|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231267|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231268|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231269|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231270|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231271|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231272|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231273|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231274|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231465|NCT01454531|B1|Baseline|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
231275|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231276|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231277|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231278|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231279|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231280|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231281|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231282|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231283|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231284|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231285|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231286|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231287|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231288|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231289|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231290|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231363|NCT01454791|B1|Baseline|Diclofenac Sodium Topical Gel Followed by Placebo|"diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks followed by two weeks of placebo~Placebo: a placebo gel is applied 1-4 times per day for two weeks."
231291|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231292|NCT01455012|E2|Reported Event|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231293|NCT01455012|E1|Reported Event|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
231294|NCT01454947|B9|Baseline|Total|Total of all reporting groups
231295|NCT01454947|B8|Baseline|SA, AJ, PC|Participants are given all 3 interventions.
231296|NCT01454947|B7|Baseline|AJ, PC|Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternative intervention.
231297|NCT01454947|B6|Baseline|SA, PC|Participants receive the Suggested Alternative and Peer Comparison interventions, but not the Accountable Justification intervention.
231298|NCT01454947|B5|Baseline|SA, AJ|Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention.
231299|NCT01454947|B4|Baseline|Peer Comparison (PC)|Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.
231300|NCT01454947|B3|Baseline|Accountable Justification (AJ)|Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
231301|NCT01454947|B2|Baseline|Suggested Alternatives (SA)|Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
231302|NCT01454947|B1|Baseline|Education Control|Participants do not receive any of the 3 interventions.
231303|NCT01454947|P8|Participant Flow|SA, AJ, PC|Participants are given all 3 interventions.
231304|NCT01454947|P7|Participant Flow|AJ, PC|Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternative intervention.
231305|NCT01454947|P6|Participant Flow|SA, PC|Participants receive the Suggested Alternative and Peer Comparison interventions, but not the Accountable Justification intervention.
231306|NCT01454947|P5|Participant Flow|SA, AJ|Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention.
231307|NCT01454947|P4|Participant Flow|Peer Comparison (PC)|Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.
231308|NCT01454947|P3|Participant Flow|Accountable Justification (AJ)|Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
231309|NCT01454947|P2|Participant Flow|Suggested Alternatives (SA)|Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
231310|NCT01454947|P1|Participant Flow|Education Control|Participants do not receive any of the 3 interventions.
231311|NCT01454947|O8|Outcome|SA+AJ+PC|Participants receive all three interventions: Suggested Alternatives, Accountable Justification, and Peer Comparison interventions
231312|NCT01454947|O7|Outcome|Accountable Justification + Peer Comparison|Participants receive the Accountable Justification and Peer Comparison interventions, but do not receive the Suggested Alternatives intervention
231313|NCT01454947|O6|Outcome|Suggested Alternatives + Peer Comparison|Participants receive the Suggested Alternatives and Peer Comparison interventions, but do not receive the Accountable Justification intervention
231314|NCT01454947|O5|Outcome|Suggested Alternatives + Accountable Justification|Participants receive the Suggested Alternatives and Accountable Justification interventions, but do not receive the Peer Comparison intervention
231315|NCT01454947|O4|Outcome|Peer Comparison (PC)|Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.
231316|NCT01454947|O3|Outcome|Accountable Justification (AJ)|Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
231317|NCT01454947|O2|Outcome|Suggested Alternatives (SA)|Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
231318|NCT01454947|O1|Outcome|Control|Participants received no study interventions
231319|NCT01454947|E8|Reported Event|SA, AJ, PC|Participants are given all 3 interventions.
231320|NCT01454947|E7|Reported Event|AJ, PC|Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternative intervention.
231321|NCT01454947|E6|Reported Event|SA, PC|Participants receive the Suggested Alternative and Peer Comparison interventions, but not the Accountable Justification intervention.
231322|NCT01454947|E5|Reported Event|SA, AJ|Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention.
231323|NCT01454947|E4|Reported Event|Peer Comparison (PC)|Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.
231324|NCT01454947|E3|Reported Event|Accountable Justification (AJ)|Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
231325|NCT01454947|E2|Reported Event|Suggested Alternatives (SA)|Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
231326|NCT01454947|E1|Reported Event|Education Control|Participants do not receive any of the 3 interventions.
231327|NCT01454934|B3|Baseline|Total|Total of all reporting groups
231328|NCT01454934|B2|Baseline|Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed|Treatment of Physician's Choice (TPC): Vinorelbine (30 mg/m2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m2 ) was administered IV on Day 1 every 21 days (nonsquamous histology only).
231329|NCT01454934|B1|Baseline|Arm A: Erubulin Mesilate|Eribulin mesilate (1.4 mg/m2) was administered intravenously (IV) over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
231330|NCT01454934|P2|Participant Flow|Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed|Treatment of Physician's Choice (TPC): Vinorelbine (30 mg/m2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m2 ) was administered IV on Day 1 every 21 days (nonsquamous histology only).
231331|NCT01454934|P1|Participant Flow|Arm A: Erubulin Mesilate|Eribulin mesilate (1.4 mg/m2) was administered intravenously (IV) over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
231332|NCT01454934|O2|Outcome|Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed|Treatment of Physician's Choice (TPC): Vinorelbine (30 mg/m2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m2 ) was administered IV on Day 1 every 21 days (nonsquamous histology only).
231333|NCT01454934|O1|Outcome|Arm A: Erubulin Mesilate|Eribulin mesilate (1.4 mg/m2) was administered intravenously (IV) over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
231334|NCT01454934|O2|Outcome|Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed|Treatment of Physician's Choice (TPC): Vinorelbine (30 mg/m2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m2 ) was administered IV on Day 1 every 21 days (nonsquamous histology only).
231335|NCT01454934|O1|Outcome|Arm A: Erubulin Mesilate|Eribulin mesilate (1.4 mg/m2) was administered intravenously (IV) over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
231336|NCT01454934|O2|Outcome|Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed|Treatment of Physician's Choice (TPC): Vinorelbine (30 mg/m2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m2 ) was administered IV on Day 1 every 21 days (nonsquamous histology only).
231337|NCT01454934|O1|Outcome|Arm A: Erubulin Mesilate|Eribulin mesilate (1.4 mg/m2) was administered intravenously (IV) over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
231338|NCT01454934|E2|Reported Event|Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed|Treatment of Physician's Choice (TPC): Vinorelbine (30 mg/m2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m2 ) was administered IV on Day 1 every 21 days (nonsquamous histology only).
231339|NCT01454934|E1|Reported Event|Arm A: Erubulin Mesilate|Eribulin mesilate (1.4 mg/m2) was administered intravenously (IV) over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
231340|NCT01454830|B3|Baseline|Total|Total of all reporting groups
231341|NCT01454830|B2|Baseline|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
231342|NCT01454830|B1|Baseline|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
231343|NCT01454830|P2|Participant Flow|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
231344|NCT01454830|P1|Participant Flow|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
231345|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
231346|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
231391|NCT01454726|E1|Reported Event|Experimental Group|receiving both Diaoshi Jifa therapy and the Western medical treatment.
231347|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
231348|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
231349|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
231350|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
231351|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
231352|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
231353|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
231354|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
231355|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
231356|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
231357|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
231358|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
231359|NCT01454830|E2|Reported Event|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
231360|NCT01454830|E1|Reported Event|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
231361|NCT01454791|B3|Baseline|Total|Total of all reporting groups
231362|NCT01454791|B2|Baseline|Placebo Followed by Diclofenac Sodium Gel|"placebo for 2 weeks followed by diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks~Placebo: a placebo gel is applied 1-4 times per day for two weeks."
231392|NCT01454583|B4|Baseline|Total|Total of all reporting groups
231393|NCT01454583|B3|Baseline|Group C|Patients without any RAS inhibition (No-RAS-I)
231364|NCT01454791|P2|Participant Flow|Placebo Followed by Diclofenac Sodium Topical Gel|"Placebo for two weeks followed by diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks~Placebo: a placebo gel is applied 1-4 times per day for two weeks."
231365|NCT01454791|P1|Participant Flow|Diclofenac Sodium Topical Gel Followed by Placebo|"diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks followed by two weeks of placebo~Placebo: a placebo gel is applied 1-4 times per day for two weeks."
231366|NCT01454791|O2|Outcome|Placebo|Placebo for two weeks: a placebo gel is applied 1-4 times per day
231367|NCT01454791|O1|Outcome|Diclofenac Sodium Topical Gel|diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks
231368|NCT01454791|O2|Outcome|Placebo|Placebo for 2 weeks: a placebo gel is applied 1-4 times per day
231369|NCT01454791|O1|Outcome|Diclofenac Sodium Topical Gel|diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks
231370|NCT01454791|O2|Outcome|Placebo|Placebo for 2 weeks: a placebo gel is applied 1-4 times per day.
231371|NCT01454791|O1|Outcome|Diclofenac Sodium Topical Gel|diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks
231372|NCT01454791|E2|Reported Event|Placebo|"1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active).~diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo~Placebo: a placebo gel is applied 1-4 times per day for two weeks."
231373|NCT01454791|E1|Reported Event|Diclofenac Sodium Topical Gel|"1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active).~diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo~Placebo: a placebo gel is applied 1-4 times per day for two weeks."
231374|NCT01454778|B1|Baseline|Paclitaxel|"Paclitaxel: Paclitaxel in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
231375|NCT01454778|P1|Participant Flow|Paclitaxel|"Paclitaxel: Paclitaxel in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
231376|NCT01454778|O1|Outcome|Paclitaxel|"Paclitaxel: Paclitaxel coating in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
231377|NCT01454778|O1|Outcome|Paclitaxel|"Paclitaxel: Paclitaxel coating in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
231378|NCT01454778|O1|Outcome|Paclitaxel|"Paclitaxel: Paclitaxel coating in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
231379|NCT01454778|O1|Outcome|Paclitaxel|"Paclitaxel: Paclitaxel coating in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
231380|NCT01454778|O1|Outcome|Paclitaxel|"Paclitaxel: Paclitaxel coating in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
231381|NCT01454778|O1|Outcome|Paclitaxel|"Paclitaxel: Paclitaxel coating in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
231382|NCT01454778|E1|Reported Event|Paclitaxel|"Paclitaxel: Paclitaxel in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
231383|NCT01454726|B3|Baseline|Total|Total of all reporting groups
231384|NCT01454726|B2|Baseline|Control Group|receiving the Western medical treatment alone.
231385|NCT01454726|B1|Baseline|Experimental Group|receiving both Diaoshi Jifa therapy and the Western medical treatment.
231386|NCT01454726|P2|Participant Flow|Control Group|receiving the Western medical treatment alone.
231387|NCT01454726|P1|Participant Flow|Experimental Group|receiving both Diaoshi Jifa therapy and the Western medical treatment.
231388|NCT01454726|O2|Outcome|Control Group|receiving the Western medical treatment alone.
231389|NCT01454726|O1|Outcome|Experimental Group|receiving both Diaoshi Jifa therapy and the Western medical treatment.
231390|NCT01454726|E2|Reported Event|Control Group|receiving the Western medical treatment alone.
231396|NCT01454583|P3|Participant Flow|No RAS-inhibition|Patients treated with no RAS-inhibition drugs at baseline. In the 3rd year period, only patients with Diabetes Mellitus (DM) or Heart Failure (HF) were considered.
231397|NCT01454583|P2|Participant Flow|ACE-I/ARB|Patients treated with ACE-I or ARB (ARB/ACE-I) at baseline. In the 3rd year period, only patients with Diabetes Mellitus (DM) or Heart Failure (HF) were considered.
231398|NCT01454583|P1|Participant Flow|Aliskiren|Patients treated with Aliskiren (DRI) at baseline. In the 3rd year period, only patients with Diabetes Mellitus (DM) or Heart Failure (HF) were considered.
231399|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
231400|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
231401|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
231402|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
231403|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
231404|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
231405|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
231406|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
231407|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
231408|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
231409|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
231410|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
231411|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
231412|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
231413|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
231414|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
231415|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
231416|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
231417|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
231418|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
231419|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
231420|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
231421|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
231422|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
231423|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
231424|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
231425|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
231426|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
231427|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
231428|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
231429|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
231430|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
231431|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
231432|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
231433|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
231434|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
231435|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
231436|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
231437|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
231438|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
231439|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
231440|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
231441|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
231442|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
231443|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
231444|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
231445|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
231446|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
231447|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
231448|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
231449|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
231450|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
231451|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
231452|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
231453|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
231454|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
231455|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
231456|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
231457|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
231458|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
231459|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
231460|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
231461|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
231462|NCT01454583|E3|Reported Event|Group C|Patients without any RAS inhibition (No-RAS-I)
231463|NCT01454583|E2|Reported Event|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
231466|NCT01454531|P1|Participant Flow|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
231467|NCT01454531|O1|Outcome|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
231468|NCT01454531|O1|Outcome|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
231469|NCT01454531|O1|Outcome|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
231470|NCT01454531|O1|Outcome|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
231471|NCT01454531|O1|Outcome|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
231472|NCT01454531|O1|Outcome|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
231473|NCT01454531|E1|Reported Event|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
231474|NCT01454505|B4|Baseline|Total|Total of all reporting groups
231475|NCT01454505|B3|Baseline|Stage B/Vehicle|Vehicle nasal spray, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
231476|NCT01454505|B2|Baseline|Stage B/AL-53817|AL-53817 nasal spray solution, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
231477|NCT01454505|B1|Baseline|Stage A/Healthy Volunteers|AL-53817 nasal spray solution in 1 of 3 concentration doses, 1 or 2 sprays per nostril, OR Vehicle, 1 spray per nostril
231478|NCT01454505|P4|Participant Flow|Stage B/Vehicle|Vehicle nasal spray, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
231479|NCT01454505|P3|Participant Flow|Stage B/AL-53817|AL-53817 nasal spray solution, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
231480|NCT01454505|P2|Participant Flow|Stage A/Vehicle|Vehicle, 1 or 2 sprays per nostril, single dose
231481|NCT01454505|P1|Participant Flow|Stage A/AL-53817|AL-53817 nasal spray solution in 1 of 3 concentrations, 1 or 2 sprays per nostril, single dose
231482|NCT01454505|O2|Outcome|Stage B/Vehicle|Vehicle nasal spray, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC.
231483|NCT01454505|O1|Outcome|Stage B/AL-53817|AL-53817 nasal spray solution, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC.
231484|NCT01454505|O2|Outcome|Stage B/Vehicle|Vehicle nasal spray, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC.
231485|NCT01454505|O1|Outcome|Stage B/AL-53817|AL-53817 nasal spray solution, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC.
231486|NCT01454505|O2|Outcome|Stage A/Vehicle|Vehicle, 1 or 2 sprays per nostril, single dose
231487|NCT01454505|O1|Outcome|Stage A/AL-53817|AL-53817 nasal spray solution in 1 of 3 concentrations, 1 or 2 sprays per nostril, single dose
231488|NCT01454505|E4|Reported Event|Stage B/Vehicle|Vehicle nasal spray, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
231489|NCT01454505|E3|Reported Event|Stage B/AL-53817|AL-53817 nasal spray solution, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
231490|NCT01454505|E2|Reported Event|Stage A/Vehicle|Vehicle, 1 or 2 sprays per nostril, single dose
231491|NCT01454505|E1|Reported Event|Stage A/AL-53817|AL-53817 nasal spray solution in 1 of 3 concentrations, 1 or 2 sprays per nostril, single dose
231492|NCT01454414|B3|Baseline|Total|Total of all reporting groups
231493|NCT01454414|B2|Baseline|Placebo|Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
231494|NCT01454414|B1|Baseline|Permethrin Impregnated Uniforms|"Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin.~Permethrin Impregnated Uniforms: Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc."
231495|NCT01454414|P2|Participant Flow|Placebo|Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
231496|NCT01454414|P1|Participant Flow|Permethrin Impregnated Uniforms|"Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin.~Permethrin Impregnated Uniforms: Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc."
231497|NCT01454414|O2|Outcome|Placebo|Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
231498|NCT01454414|O1|Outcome|Permethrin Impregnated Uniforms|"Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin.~Permethrin Impregnated Uniforms: Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc."
231499|NCT01454414|E2|Reported Event|Placebo|Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
231500|NCT01454414|E1|Reported Event|Permethrin Impregnated Uniforms|"Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin.~Permethrin Impregnated Uniforms: Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc."
231501|NCT01454401|B1|Baseline|LeucoPatch Treatment of Diabetic Foot Ulcers|"Weekly treatment~LeucoPatch device: weekly treatment"
231502|NCT01454401|P1|Participant Flow|LeucoPatch Treatment of Diabetic Foot Ulcers|Weekly LeucoPatch treatment of diabetic foot ulcers
231503|NCT01454401|O1|Outcome|LeucoPatch|LeucoPatch: weekly treatment
231504|NCT01454401|O1|Outcome|LeucoPatch|LeucoPatch: weekly treatment
231505|NCT01454401|E1|Reported Event|All Patients Consenting to be Enrolled in the Study.|"60 patients were included for a 2 week run-in period. If ulcer area decreased more than 40% during that time the ulcer were deemed healing and NOT included for treatment. 16 patients were excluded during the run-in period - 44 were treated. For safety analysis all patients were included"
231506|NCT01454284|B3|Baseline|Total|Total of all reporting groups
231507|NCT01454284|B2|Baseline|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231623|NCT01454063|B3|Baseline|Total|Total of all reporting groups
231508|NCT01454284|B1|Baseline|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231509|NCT01454284|P2|Participant Flow|Insulin Glargine + Insulin Lispro|"Includes participants randomized to receive Insulin Glargine plus Insulin Lispro.~Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231510|NCT01454284|P1|Participant Flow|LY2605541 + Insulin Lispro|"Includes participants randomized to receive LY2605541 plus Insulin Lispro.~Participant-specific dose of LY2605541 was administered subcutaneously (SC) once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231511|NCT01454284|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231512|NCT01454284|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231513|NCT01454284|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231514|NCT01454284|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231515|NCT01454284|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231516|NCT01454284|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231517|NCT01454284|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231518|NCT01454284|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231519|NCT01454284|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231520|NCT01454284|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231521|NCT01454284|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231522|NCT01454284|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231523|NCT01454284|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231524|NCT01454284|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231525|NCT01454284|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231526|NCT01454284|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231527|NCT01454284|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231528|NCT01454284|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231529|NCT01454284|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231530|NCT01454284|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231531|NCT01454284|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231532|NCT01454284|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231533|NCT01454284|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231534|NCT01454284|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231535|NCT01454284|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231536|NCT01454284|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231537|NCT01454284|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231538|NCT01454284|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231539|NCT01454284|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231540|NCT01454284|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231541|NCT01454284|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231542|NCT01454284|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231543|NCT01454284|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231544|NCT01454284|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231545|NCT01454284|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231546|NCT01454284|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231547|NCT01454284|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231548|NCT01454284|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231549|NCT01454284|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231550|NCT01454284|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231551|NCT01454284|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231552|NCT01454284|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231553|NCT01454284|O2|Outcome|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231554|NCT01454284|O1|Outcome|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231555|NCT01454284|E2|Reported Event|Insulin Glargine + Insulin Lispro|"Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231556|NCT01454284|E1|Reported Event|LY2605541 + Insulin Lispro|"Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.~Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks."
231557|NCT01454258|B1|Baseline|Cohort|Surgical patients from 10 hospitals over a period of 13 months
231558|NCT01454258|P1|Participant Flow|Cohort|Surgical patients from 10 hospitals over a period of 13 months
231559|NCT01454258|O3|Outcome|Other Colloids|gelatine, albumin,
231560|NCT01454258|O2|Outcome|Hydroxyethyl Starch|HES
231561|NCT01454258|O1|Outcome|Crystalloids|crystalloids
231562|NCT01454258|E1|Reported Event|Cohort|Surgical patients
231563|NCT01454076|B6|Baseline|Total|Total of all reporting groups
231564|NCT01454076|B5|Baseline|Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg|Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231565|NCT01454076|B4|Baseline|Arm 4: Ixazomib 4 mg + Rifampin 600 mg|Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231675|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231566|NCT01454076|B3|Baseline|Arm 3: Ixazomib 4 mg Fasted or Fed|Ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fed state, once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, under fed state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231567|NCT01454076|B2|Baseline|Arm 2: Ixazomib 4 mg Capsule A or B|Ixazomib 4 mg, capsule A, orally, once on Day 1 followed by ixazomib 4 mg, capsule B once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, once on Day 1 followed by ixazomib 4 mg, capsule A once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231568|NCT01454076|B1|Baseline|Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg|Ixazomib 2.5 milligram (mg), capsule B, orally, once on Day 1 and 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231569|NCT01454076|P5|Participant Flow|Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg|Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231570|NCT01454076|P4|Participant Flow|Arm 4: Ixazomib 4 mg + Rifampin 600 mg|Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231571|NCT01454076|P3|Participant Flow|Arm 3: Ixazomib 4 mg Fasted or Fed|Ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fed state, once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, under fed state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231572|NCT01454076|P2|Participant Flow|Arm 2: Ixazomib 4 mg Capsule A or B|Ixazomib 4 mg, capsule A, orally, once on Day 1 followed by ixazomib 4 mg, capsule B once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, once on Day 1 followed by ixazomib 4 mg, capsule A once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231573|NCT01454076|P1|Participant Flow|Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg|Ixazomib 2.5 milligram (mg), capsule B, orally, once on Day 1 and 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231574|NCT01454076|O8|Outcome|Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg|Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle).
231575|NCT01454076|O7|Outcome|Arm 4: Ixazomib 4 mg + Rifampin 600 mg|Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle).
231576|NCT01454076|O6|Outcome|Arm 3: Ixazomib 4 mg Fed|Ixazomib 4 mg, capsule B, orally, under fed conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
231577|NCT01454076|O5|Outcome|Arm 3: Ixazomib 4 mg Fasted|Ixazomib 4 mg, capsule B, orally, under fasted conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
231578|NCT01454076|O4|Outcome|Arm 2: Ixazomib 4 mg Capsule B|Ixazomib 4 mg, capsule B, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
231579|NCT01454076|O3|Outcome|Arm 2: Ixazomib 4 mg Capsule A|Ixazomib 4 mg, capsule A, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
231580|NCT01454076|O2|Outcome|Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg|Ixazomib 2.5 mg, capsule B, orally, once on Day 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle).
231581|NCT01454076|O1|Outcome|Arm 1: Ixazomib 2.5 mg|Ixazomib 2.5 mg, capsule B, orally, once on Day 1 of Cycle 1 (28-day treatment cycle).
231582|NCT01454076|O5|Outcome|Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg|Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles (28-day treatment cycle), until disease progression or unacceptable toxicity.
231583|NCT01454076|O4|Outcome|Arm 4: Ixazomib 4 mg + Rifampin 600 mg|Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231584|NCT01454076|O3|Outcome|Arm 3: Ixazomib 4 mg Fasted or Fed|Ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fed state, once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, under fed state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231585|NCT01454076|O2|Outcome|Arm 2: Ixazomib 4 mg Capsule A or B|Ixazomib 4 mg, capsule A, orally, once on Day 1 followed by ixazomib 4 mg, capsule B once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, once on Day 1 followed by ixazomib 4 mg, capsule A once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231586|NCT01454076|O1|Outcome|Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg|Ixazomib 2.5 mg, capsule B, orally, once on Day 1 and 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231587|NCT01454076|O5|Outcome|Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg|Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles (28-day treatment cycle), until disease progression or unacceptable toxicity.
231588|NCT01454076|O4|Outcome|Arm 4: Ixazomib 4 mg + Rifampin 600 mg|Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231589|NCT01454076|O3|Outcome|Arm 3: Ixazomib 4 mg Fasted or Fed|Ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fed state, once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, under fed state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231590|NCT01454076|O2|Outcome|Arm 2: Ixazomib 4 mg Capsule A or B|Ixazomib 4 mg, capsule A, orally, once on Day 1 followed by ixazomib 4 mg, capsule B once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, once on Day 1 followed by ixazomib 4 mg, capsule A once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231591|NCT01454076|O1|Outcome|Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg|Ixazomib 2.5 mg, capsule B, orally, once on Day 1 and 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231592|NCT01454076|O5|Outcome|Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg|Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles (28-day treatment cycle), until disease progression or unacceptable toxicity.
231593|NCT01454076|O4|Outcome|Arm 4: Ixazomib 4 mg + Rifampin 600 mg|Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231594|NCT01454076|O3|Outcome|Arm 3: Ixazomib 4 mg Fasted or Fed|Ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fed state, once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, under fed state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231595|NCT01454076|O2|Outcome|Arm 2: Ixazomib 4 mg Capsule A or B|Ixazomib 4 mg, capsule A, orally, once on Day 1 followed by ixazomib 4 mg, capsule B once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, once on Day 1 followed by ixazomib 4 mg, capsule A once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231596|NCT01454076|O1|Outcome|Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg|Ixazomib 2.5 mg, capsule B, orally, once on Day 1 and 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231597|NCT01454076|O5|Outcome|Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg|Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles (28-day treatment cycle), until disease progression or unacceptable toxicity.
231598|NCT01454076|O4|Outcome|Arm 4: Ixazomib 4 mg + Rifampin 600 mg|Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle). Participant received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231702|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231599|NCT01454076|O3|Outcome|Arm 3: Ixazomib 4 mg Fasted or Fed|Ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fed state, once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, under fed state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231600|NCT01454076|O2|Outcome|Arm 2: Ixazomib 4 mg Capsule A or B|Ixazomib 4 mg, capsule A, orally, once on Day 1 followed by ixazomib 4 mg, capsule B once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, once on Day 1 followed by ixazomib 4 mg, capsule A once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231601|NCT01454076|O1|Outcome|Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg|Ixazomib 2.5 mg, capsule B, orally, once on Day 1 and 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231602|NCT01454076|O8|Outcome|Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg|Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle).
231603|NCT01454076|O7|Outcome|Arm 4: Ixazomib 4 mg + Rifampin 600 mg|Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle).
231604|NCT01454076|O6|Outcome|Arm 3: Ixazomib 4 mg Fed|Ixazomib 4 mg, capsule B, orally, under fed conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
231605|NCT01454076|O5|Outcome|Arm 3: Ixazomib 4 mg Fasted|Ixazomib 4 mg, capsule B, orally, under fasted conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
231606|NCT01454076|O4|Outcome|Arm 2: Ixazomib 4 mg Capsule B|Ixazomib 4 mg, capsule B, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
231607|NCT01454076|O3|Outcome|Arm 2: Ixazomib 4 mg Capsule A|Ixazomib 4 mg, capsule A, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
231608|NCT01454076|O2|Outcome|Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg|Ixazomib 2.5 mg, capsule B, orally, once on Day 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle).
231609|NCT01454076|O1|Outcome|Arm 1: Ixazomib 2.5 mg|Ixazomib 2.5 mg, capsule B, orally, once on Day 1 of Cycle 1 (28-day treatment cycle).
231610|NCT01454076|O8|Outcome|Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg|Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle).
231611|NCT01454076|O7|Outcome|Arm 4: Ixazomib 4 mg + Rifampin 600 mg|Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle).
231612|NCT01454076|O6|Outcome|Arm 3: Ixazomib 4 mg Fed|Ixazomib 4 mg, capsule B, orally, under fed conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
231613|NCT01454076|O5|Outcome|Arm 3: Ixazomib 4 mg Fasted|Ixazomib 4 mg, capsule B, orally, under fasted conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
231614|NCT01454076|O4|Outcome|Arm 2: Ixazomib 4 mg Capsule B|Ixazomib 4 mg, capsule B, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
231615|NCT01454076|O3|Outcome|Arm 2: Ixazomib 4 mg Capsule A|Ixazomib 4 mg, capsule A, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
231616|NCT01454076|O2|Outcome|Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg|Ixazomib 2.5 mg, capsule B, orally, once on Day 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle).
231617|NCT01454076|O1|Outcome|Arm 1: Ixazomib 2.5 mg|Ixazomib 2.5 mg, capsule B, orally, once on Day 1 of Cycle 1 (28-day treatment cycle).
231618|NCT01454076|E5|Reported Event|Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg|Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231619|NCT01454076|E4|Reported Event|Arm 4: Ixazomib 4 mg + Rifampin 600 mg|Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231620|NCT01454076|E3|Reported Event|Arm 3: Ixazomib 4 mg Fasted or Fed|Ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fed state, once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, under fed state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231621|NCT01454076|E2|Reported Event|Arm 2: Ixazomib 4 mg Capsule A or B|Ixazomib 4 mg, capsule A, orally, once on Day 1 followed by ixazomib 4 mg, capsule B once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, once on Day 1 followed by ixazomib 4 mg, capsule A once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231622|NCT01454076|E1|Reported Event|Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg|Ixazomib 2.5 mg, capsule B, orally, once on Day 1 and 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
231624|NCT01454063|B2|Baseline|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
231625|NCT01454063|B1|Baseline|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine hydrochloride (HCl) and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
231626|NCT01454063|P2|Participant Flow|Placebo|"Placebo diluted in Balanced Salt Solution (BSS) and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
231627|NCT01454063|P1|Participant Flow|OMS302|"OMS302 diluted in Balanced Salt Solution (BSS) and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 millimolar (mM) phenylephrine hydrochloride (HCl) and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
231628|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
231629|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
231630|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
231631|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
231632|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
231633|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
231634|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
231648|NCT01453998|P3|Participant Flow|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
232818|NCT01451398|B3|Baseline|Total|Total of all reporting groups
231635|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
231636|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
231637|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
231638|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
231639|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
231640|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
231641|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
231642|NCT01454063|E2|Reported Event|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
231643|NCT01454063|E1|Reported Event|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
231644|NCT01453998|B4|Baseline|Total|Total of all reporting groups
231645|NCT01453998|B3|Baseline|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231646|NCT01453998|B2|Baseline|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231647|NCT01453998|B1|Baseline|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231649|NCT01453998|P2|Participant Flow|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231650|NCT01453998|P1|Participant Flow|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231651|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231652|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231653|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231654|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231655|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231656|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231657|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231658|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231659|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231660|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231661|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231781|NCT01453569|O1|Outcome|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
231782|NCT01453569|O3|Outcome|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
231662|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231663|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231664|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231665|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231666|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231667|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231668|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231669|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231670|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231671|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231672|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231673|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231674|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231783|NCT01453569|O2|Outcome|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
231900|NCT01453374|E1|Reported Event|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
231676|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231677|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231678|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231679|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231680|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231681|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231682|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231683|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231684|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231685|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231686|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231687|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231688|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231784|NCT01453569|O1|Outcome|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
231785|NCT01453569|O3|Outcome|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
231689|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231690|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231691|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231692|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231693|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231694|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231695|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231696|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231697|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231698|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231699|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231700|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231701|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231786|NCT01453569|O2|Outcome|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
232551|NCT01451554|O1|Outcome|Portion Control Intervention|Individuals will be given a portion control plate and dietary counseling
231703|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231704|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231705|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231706|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231707|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231708|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231709|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231710|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231711|NCT01453998|E3|Reported Event|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231712|NCT01453998|E2|Reported Event|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231713|NCT01453998|E1|Reported Event|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
231714|NCT01453946|B1|Baseline|Entocort|Entocort 6 mg/day
231715|NCT01453946|P1|Participant Flow|Entocort|Entocort 6 mg/day
231716|NCT01453946|O1|Outcome|Entocort|Entocort 6 mg/day
231717|NCT01453946|O1|Outcome|Entocort|Entocort 6 mg/day
231718|NCT01453946|O1|Outcome|Entocort|Entocort 6 mg/day
231719|NCT01453946|E1|Reported Event|Entocort|Entocort 6 mg/day
231720|NCT01453894|B3|Baseline|Total|Total of all reporting groups
231721|NCT01453894|B2|Baseline|Usual Care Control Group|Patients assigned to this arm will receive usual care.
231746|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
231787|NCT01453569|O1|Outcome|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
231788|NCT01453569|O3|Outcome|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
231722|NCT01453894|B1|Baseline|Reminder and Outreach Intervention|"Participants randomized to this arm will receive the Reminder and Outreach intervention.~Reminder and Outreach Intervention: This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results."
231723|NCT01453894|P2|Participant Flow|Usual Care Control Group|Patients assigned to this arm will receive usual care.
231724|NCT01453894|P1|Participant Flow|Reminder and Outreach Intervention|"Participants randomized to this arm will receive the Reminder and Outreach intervention.~Reminder and Outreach Intervention: This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results."
231725|NCT01453894|O2|Outcome|Usual Care Control Group|Patients assigned to this arm will receive usual care.
231726|NCT01453894|O1|Outcome|Reminder and Outreach Intervention|"Participants randomized to this arm will receive the Reminder and Outreach intervention.~Reminder and Outreach Intervention: This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results."
231727|NCT01453894|E2|Reported Event|Usual Care Control Group|Patients assigned to this arm will receive usual care.
231728|NCT01453894|E1|Reported Event|Reminder and Outreach Intervention|"Participants randomized to this arm will receive the Reminder and Outreach intervention.~Reminder and Outreach Intervention: This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results."
231729|NCT01453855|B3|Baseline|Total|Total of all reporting groups
231730|NCT01453855|B2|Baseline|TRAVATAN|Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
231731|NCT01453855|B1|Baseline|Travoprost 0.003%|Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
231732|NCT01453855|P2|Participant Flow|TRAVATAN|Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
231733|NCT01453855|P1|Participant Flow|Travoprost 0.003%|Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
231734|NCT01453855|O2|Outcome|TRAVATAN|Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
231735|NCT01453855|O1|Outcome|Travoprost 0.003%|Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
231736|NCT01453855|E2|Reported Event|TRAVATAN|Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
231737|NCT01453855|E1|Reported Event|Travoprost 0.003%|Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
231738|NCT01453725|B3|Baseline|Total|Total of all reporting groups
231739|NCT01453725|B2|Baseline|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
231740|NCT01453725|B1|Baseline|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
231741|NCT01453725|P2|Participant Flow|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
231742|NCT01453725|P1|Participant Flow|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered subcutaneously (SC) every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
231743|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
231744|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
231745|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
231780|NCT01453569|O2|Outcome|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
231747|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
231748|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
231749|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
231750|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
231751|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
231752|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
231753|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
231754|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
231755|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
231756|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
231757|NCT01453725|E4|Reported Event|Part 2: Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
231758|NCT01453725|E3|Reported Event|Part 2: Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
231759|NCT01453725|E2|Reported Event|Part 1: Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
231760|NCT01453725|E1|Reported Event|Part 1: Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
231761|NCT01453595|B4|Baseline|Total|Total of all reporting groups
231762|NCT01453595|B3|Baseline|Cohort -1a: BEZ235 300mg|Cohort -1a: BEZ235 300mg by mouth twice daily
231763|NCT01453595|B2|Baseline|Cohort -1: BEZ235 200mg|Cohort -1: BEZ235 200mg by mouth twice daily
231764|NCT01453595|B1|Baseline|Cohort 1: BEZ235 400mg|Cohort 1: BEZ235 400mg by mouth twice daily
231765|NCT01453595|P3|Participant Flow|Cohort -1a: BEZ235 300mg|Cohort -1a: BEZ235 300mg by mouth twice daily
231766|NCT01453595|P2|Participant Flow|Cohort -1: BEZ235 200mg|Cohort -1: BEZ235 200mg by mouth twice daily
231767|NCT01453595|P1|Participant Flow|Cohort 1: BEZ235 400mg|Cohort 1: BEZ235 400mg by mouth twice daily
231768|NCT01453595|O1|Outcome|Cohort -1: BEZ235 200mg|Cohort -1: BEZ235 200mg by mouth twice daily
231769|NCT01453595|E3|Reported Event|Cohort -1a: BEZ235 300mg|Cohort -1a: BEZ235 300mg by mouth twice daily
231770|NCT01453595|E2|Reported Event|Cohort -1: BEZ235 200mg|Cohort -1: BEZ235 200mg by mouth twice daily
231771|NCT01453595|E1|Reported Event|Cohort 1: BEZ235 400mg|Cohort 1: BEZ235 400mg by mouth twice daily
231772|NCT01453569|B4|Baseline|Total|Total of all reporting groups
231773|NCT01453569|B3|Baseline|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
231774|NCT01453569|B2|Baseline|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
231775|NCT01453569|B1|Baseline|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
231776|NCT01453569|P3|Participant Flow|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
231777|NCT01453569|P2|Participant Flow|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
231778|NCT01453569|P1|Participant Flow|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
231779|NCT01453569|O3|Outcome|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
231789|NCT01453569|O2|Outcome|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
231790|NCT01453569|O1|Outcome|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
231791|NCT01453569|E3|Reported Event|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
231792|NCT01453569|E2|Reported Event|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
231793|NCT01453569|E1|Reported Event|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
231794|NCT01453413|B1|Baseline|People With Type 2 Diabetes|People with type 2 diabetes who were in attendance at a diabetes conference were asked for their perceived Blood Glucose (BG) value. Then, after staff measured BG on Contour® Blood Glucose meter, subjects were informed of their BG value. Three subjects were excluded from all analyses due to inconsistencies in responses to inclusion / exclusion questions. So 294 subjects were included in demographics analyses.
231795|NCT01453413|P1|Participant Flow|People With Type 2 Diabetes|Perceived BG value versus measured BG for people with type 2 diabetes who are in attendance at a diabetes conference
231796|NCT01453413|O1|Outcome|People With Type 2 Diabetes|People with type 2 diabetes who were in attendance at a diabetes conference were asked for their perceived Blood Glucose (BG) value. Then, after staff measured BG on Contour® Blood Glucose meter, subjects were informed of their BG value. Three subjects were excluded from all analyses due to inconsistencies in responses to inclusion / exclusion questions. So 294 subjects were included in demographics analyses.
231797|NCT01453413|O1|Outcome|People With Type 2 Diabetes|People with type 2 diabetes who were in attendance at a diabetes conference were asked for their perceived Blood Glucose (BG) value. Then, after staff measured BG on Contour® Blood Glucose meter, subjects were informed of their BG value. Three subjects were excluded from all analyses due to inconsistencies in responses to inclusion / exclusion questions. So 294 subjects were included in demographics analyses.
231798|NCT01453413|E1|Reported Event|People With Type 2 Diabetes|Perceived BG value versus measured BG for people with type 2 diabetes who are in attendance at a diabetes conference
231799|NCT01453387|B3|Baseline|Total|Total of all reporting groups
231800|NCT01453387|B2|Baseline|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
231801|NCT01453387|B1|Baseline|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until maximum tolerated dose (MTD) was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
231802|NCT01453387|P2|Participant Flow|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
231803|NCT01453387|P1|Participant Flow|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until maximum tolerated dose (MTD) was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
231804|NCT01453387|O2|Outcome|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, which was escalated to 200 mcg.
231805|NCT01453387|O1|Outcome|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg.
231806|NCT01453387|O2|Outcome|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, which was escalated to 200 mcg.
231807|NCT01453387|O1|Outcome|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg.
231808|NCT01453387|O2|Outcome|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, which was escalated to 200 mcg.
231809|NCT01453387|O1|Outcome|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg.
231810|NCT01453387|O9|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 2)|MSC2015103B 200 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
231811|NCT01453387|O8|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 2)|MSC2015103B 150 mcg was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
231812|NCT01453387|O7|Outcome|Part 1 - MSC2015103B 1500 mcg (Schedule 1)|MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231813|NCT01453387|O6|Outcome|Part 1 - MSC2015103B 1000 mcg (Schedule 1)|MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231814|NCT01453387|O5|Outcome|Part 1 - MSC2015103B 650 mcg (Schedule 1)|MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231815|NCT01453387|O4|Outcome|Part 1 - MSC2015103B 450 mcg (Schedule 1)|MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231816|NCT01453387|O3|Outcome|Part 1 - MSC2015103B 300 mcg (Schedule 1)|MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231817|NCT01453387|O2|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 1)|MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231818|NCT01453387|O1|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 1)|MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231859|NCT01453387|O5|Outcome|Part 1 - MSC2015103B 650 mcg (Schedule 1)|MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231819|NCT01453387|O9|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 2)|MSC2015103B 200 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
231820|NCT01453387|O8|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 2)|MSC2015103B 150 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
231821|NCT01453387|O7|Outcome|Part 1 - MSC2015103B 1500 mcg (Schedule 1)|MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231822|NCT01453387|O6|Outcome|Part 1 - MSC2015103B 1000 mcg (Schedule 1)|MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231823|NCT01453387|O5|Outcome|Part 1 - MSC2015103B 650 mcg (Schedule 1)|MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231824|NCT01453387|O4|Outcome|Part 1 - MSC2015103B 450 mcg (Schedule 1)|MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231825|NCT01453387|O3|Outcome|Part 1 - MSC2015103B 300 mcg (Schedule 1)|MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231826|NCT01453387|O2|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 1)|MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231827|NCT01453387|O1|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 1)|MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231828|NCT01453387|O9|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 2)|MSC2015103B 200 mcg was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
231829|NCT01453387|O8|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 2)|MSC2015103B 150 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
231830|NCT01453387|O7|Outcome|Part 1 - MSC2015103B 1500 mcg (Schedule 1)|MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231831|NCT01453387|O6|Outcome|Part 1 - MSC2015103B 1000 mcg (Schedule 1)|MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231832|NCT01453387|O5|Outcome|Part 1 - MSC2015103B 650 mcg (Schedule 1)|MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231833|NCT01453387|O4|Outcome|Part 1 - MSC2015103B 450 mcg (Schedule 1)|MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231834|NCT01453387|O3|Outcome|Part 1 - MSC2015103B 300 mcg (Schedule 1)|MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231835|NCT01453387|O2|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 1)|MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231836|NCT01453387|O1|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 1)|MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231837|NCT01453387|O9|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 2)|MSC2015103B 200 mcg was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
231838|NCT01453387|O8|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 2)|MSC2015103B 150 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
231839|NCT01453387|O7|Outcome|Part 1 - MSC2015103B 1500 mcg (Schedule 1)|MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231840|NCT01453387|O6|Outcome|Part 1 - MSC2015103B 1000 mcg (Schedule 1)|MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231841|NCT01453387|O5|Outcome|Part 1 - MSC2015103B 650 mcg (Schedule 1)|MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231842|NCT01453387|O4|Outcome|Part 1 - MSC2015103B 450 mcg (Schedule 1)|MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231843|NCT01453387|O3|Outcome|Part 1 - MSC2015103B 300 mcg (Schedule 1)|MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231844|NCT01453387|O2|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 1)|MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231845|NCT01453387|O1|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 1)|MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231846|NCT01453387|O9|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 2)|MSC2015103B 200 mcg was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
231847|NCT01453387|O8|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 2)|MSC2015103B 150 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
231848|NCT01453387|O7|Outcome|Part 1 - MSC2015103B 1500 mcg (Schedule 1)|MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231849|NCT01453387|O6|Outcome|Part 1 - MSC2015103B 1000 mcg (Schedule 1)|MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231850|NCT01453387|O5|Outcome|Part 1 - MSC2015103B 650 mcg (Schedule 1)|MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231851|NCT01453387|O4|Outcome|Part 1 - MSC2015103B 450 mcg (Schedule 1)|MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231852|NCT01453387|O3|Outcome|Part 1 - MSC2015103B 300 mcg (Schedule 1)|MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231853|NCT01453387|O2|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 1)|MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231854|NCT01453387|O1|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 1)|MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231855|NCT01453387|O9|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 2)|MSC2015103B 200 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
231856|NCT01453387|O8|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 2)|MSC2015103B 150 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
231857|NCT01453387|O7|Outcome|Part 1 - MSC2015103B 1500 mcg (Schedule 1)|MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231858|NCT01453387|O6|Outcome|Part 1 - MSC2015103B 1000 mcg (Schedule 1)|MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231860|NCT01453387|O4|Outcome|Part 1 - MSC2015103B 450 mcg (Schedule 1)|MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231861|NCT01453387|O3|Outcome|Part 1 - MSC2015103B 300 mcg (Schedule 1)|MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231862|NCT01453387|O2|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 1)|MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231863|NCT01453387|O1|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 1)|MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231864|NCT01453387|O9|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 2)|MSC2015103B 200 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
231865|NCT01453387|O8|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 2)|MSC2015103B 150 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
231866|NCT01453387|O7|Outcome|Part 1 - MSC2015103B 1500 mcg (Schedule 1)|MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231867|NCT01453387|O6|Outcome|Part 1 - MSC2015103B 1000 mcg (Schedule 1)|MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231868|NCT01453387|O5|Outcome|Part 1 - MSC2015103B 650 mcg (Schedule 1)|MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231869|NCT01453387|O4|Outcome|Part 1 - MSC2015103B 450 mcg (Schedule 1)|MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231870|NCT01453387|O3|Outcome|Part 1 - MSC2015103B 300 mcg (Schedule 1)|MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231871|NCT01453387|O2|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 1)|MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231872|NCT01453387|O1|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 1)|MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
231873|NCT01453387|O2|Outcome|Part 1 - MSC2015103B (Schedule 2)|The planned dose of MSC2015103B (150 mcg and 200 mcg) was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
231874|NCT01453387|O1|Outcome|Part 1 - MSC2015103B (Schedule 1)|The planned dose of MSC2015103B (150 mcg, 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg) was orally administered once weekly on Days 1, 8, and 15 of a 21-day cycle.
231875|NCT01453387|O2|Outcome|Part 1 - MSC2015103B (Schedule 2)|The planned dose of MSC2015103B (150 mcg and 200 mcg) was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
231876|NCT01453387|O1|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 1)|The planned dose of MSC2015103B (150 mcg, 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg) was orally administered once weekly on Days 1, 8, and 15 of a 21-day cycle.
231877|NCT01453387|O2|Outcome|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
231878|NCT01453387|O1|Outcome|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
231879|NCT01453387|O2|Outcome|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
231880|NCT01453387|O1|Outcome|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
231881|NCT01453387|O2|Outcome|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
231882|NCT01453387|O1|Outcome|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until maximum tolerated dose (MTD) was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
231883|NCT01453387|E2|Reported Event|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
231884|NCT01453387|E1|Reported Event|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
231885|NCT01453374|B1|Baseline|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
231886|NCT01453374|P1|Participant Flow|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
231887|NCT01453374|O1|Outcome|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
231888|NCT01453374|O2|Outcome|All 7 Injections|Subjects who received all 7 VIVITROL injections
231889|NCT01453374|O1|Outcome|<7 Injections|Subjects who received less than 7 VIVITROL injections
231890|NCT01453374|O1|Outcome|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
231891|NCT01453374|O1|Outcome|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
231892|NCT01453374|O1|Outcome|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
231893|NCT01453374|O1|Outcome|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
231894|NCT01453374|O2|Outcome|All 7 Injections|Subjects who received all 7 VIVITROL injections
231895|NCT01453374|O1|Outcome|<7 Injections|Subjects who received less than 7 VIVITROL injections
231896|NCT01453374|O2|Outcome|All 7 Injections|Subjects who received all 7 VIVITROL injections
231897|NCT01453374|O1|Outcome|<7 Injections|Subjects who received less than 7 VIVITROL injections
231898|NCT01453374|O2|Outcome|All 7 Injections|Subjects who received all 7 VIVITROL injections
231901|NCT01453361|B1|Baseline|Vigil™ Vaccine|"Autologous Vigil™ vaccine will be supplied by Gradalis, Inc. Patients will receive 1 x 10e7 cells via intradermal injection one day each month for a minimum maximum of 12 doses as long as subject is clinically stable.~Vigil™ Vaccine"
231902|NCT01453361|P1|Participant Flow|Vigil™ Vaccine|"Autologous Vigil™ vaccine will be supplied by Gradalis, Inc. Patients will receive 1 x 10e7 cells via intradermal injection one day each month for a minimum maximum of 12 doses as long as subject is clinically stable.~Vigil™ Vaccine"
231903|NCT01453361|O1|Outcome|Vigil™ Vaccine|"Autologous Vigil™ vaccine will be supplied by Gradalis, Inc. Patients will receive 1 x 10e7 cells via intradermal injection one day each month for a minimum maximum of 12 doses as long as subject is clinically stable.~Vigil™ Vaccine"
231904|NCT01453361|O1|Outcome|Vigil™ Vaccine|"Autologous Vigil™ vaccine will be supplied by Gradalis, Inc. Patients will receive 1 x 10e7 cells via intradermal injection one day each month for a minimum maximum of 12 doses as long as subject is clinically stable.~Vigil™ Vaccine"
231905|NCT01453361|E1|Reported Event|Vigil™ Vaccine|"Autologous Vigil™ vaccine will be supplied by Gradalis, Inc. Patients will receive 1 x 10e7 cells via intradermal injection one day each month for a minimum maximum of 12 doses as long as subject is clinically stable.~Vigil™ Vaccine"
231906|NCT01453348|B4|Baseline|Total|Total of all reporting groups
231907|NCT01453348|B3|Baseline|MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
231908|NCT01453348|B2|Baseline|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
231909|NCT01453348|B1|Baseline|HepA/B|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
231910|NCT01453348|P3|Participant Flow|MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
231911|NCT01453348|P2|Participant Flow|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
231912|NCT01453348|P1|Participant Flow|HepA/B|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
231913|NCT01453348|O3|Outcome|MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
231914|NCT01453348|O2|Outcome|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
231915|NCT01453348|O1|Outcome|HepA/B|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
231916|NCT01453348|O2|Outcome|MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
232273|NCT01452347|O2|Outcome|Predicted|This includes the predicted Ctrough,ss value for all patients in the PKS who have a corresponding observed value.
231917|NCT01453348|O1|Outcome|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine ; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
231918|NCT01453348|O2|Outcome|MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
231919|NCT01453348|O1|Outcome|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine ; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
231920|NCT01453348|O2|Outcome|HepA/B|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
231921|NCT01453348|O1|Outcome|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine ; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
231922|NCT01453348|O2|Outcome|HepA/B|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
231923|NCT01453348|O1|Outcome|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine ; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
231924|NCT01453348|E3|Reported Event|ACWY|Subject ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
231925|NCT01453348|E2|Reported Event|HepA/B+ACWY|Subject ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
231926|NCT01453348|E1|Reported Event|HepA/B|Subject ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
232274|NCT01452347|O1|Outcome|Observed|This includes the observed Ctrough,ss value for all patients in the PKS who have a corresponding predicted value.
232552|NCT01451554|O2|Outcome|Usual Care|Provided with self-help booklets on diet and exercise.
231927|NCT01453296|B1|Baseline|VI 25 µg/Placebo or Placebo/VI 25 µg|Participants received either vilanterol (VI) 25 micrograms (µg) or matching placebo in the first of two 14-day treatment periods, followed by a repeat dose of the other therapy (the therapy not received in the first treatment period) in the second 14-day treatment period. Inhaled VI 25 µg or matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231928|NCT01453296|P2|Participant Flow|Sequence 2: Placebo Followed by VI 25 µg|Participants received placebo and VI 25 µg in Treatment Periods 1 and 2, respectively. Inhaled VI 25 µg and matching placebo were administered once daily in the morning (Day 1 to Day 14) via a Dry Powder Inhaler. The washout period between the 14-day treatment periods was at least 7 days.
231929|NCT01453296|P1|Participant Flow|Sequence 1: VI 25 µg Followed by Placebo|Participants received vilanterol (VI) 25 micrograms (µg) and matching placebo in Treatment Periods 1 and 2, respectively. Inhaled VI 25 µg and matching placebo were administered once daily in the morning (Day 1 to Day 14) via ae Dry Powder Inhaler. The washout period between the 14-day treatment periods was at least 7 days.
231930|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231931|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231932|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231933|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231934|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231935|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231936|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231937|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231938|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231939|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231940|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231941|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231942|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231943|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231944|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231945|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231946|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231947|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231948|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232275|NCT01452347|O2|Outcome|Predicted|This includes the predicted Ctrough,ss value for all patients in the PKS who have a corresponding observed value.
231949|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231950|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231951|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231952|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231953|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231954|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231955|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231956|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231957|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231958|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231959|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231960|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231961|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231962|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231963|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231964|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231965|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231966|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231967|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231968|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231969|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231970|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231971|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232276|NCT01452347|O1|Outcome|Observed|This includes the observed Ctrough,ss value for all patients in the PKS who have a corresponding predicted value.
231972|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231973|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231974|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231975|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231976|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231977|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231978|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231979|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231980|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231981|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231982|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231983|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231984|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231985|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231986|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231987|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231988|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231989|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231990|NCT01453296|E2|Reported Event|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231991|NCT01453296|E1|Reported Event|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
231992|NCT01453205|B4|Baseline|TOTAL|Total of all reporting groups
231993|NCT01453205|B3|Baseline|MEDI-551 4 mg/kg + ICE/DHAP|Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232277|NCT01452347|O2|Outcome|Predicted|This includes the predicted Ctrough,ss value for all patients in the PKS who have a corresponding observed value.
231994|NCT01453205|B2|Baseline|MEDI-551 2 mg/kg + ICE/DHAP|Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
231995|NCT01453205|B1|Baseline|Rituximab+ ICE/DHAP|Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
231996|NCT01453205|P3|Participant Flow|MEDI-551 4 mg/kg + ICE/DHAP|Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
231997|NCT01453205|P2|Participant Flow|MEDI-551 2 mg/kg + ICE/DHAP|Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
231998|NCT01453205|P1|Participant Flow|Rituximab+ ICE/DHAP|Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
231999|NCT01453205|O2|Outcome|MEDI-551 4 mg/kg + ICE/DHAP|Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232000|NCT01453205|O1|Outcome|MEDI-551 2 mg/kg + ICE/DHAP|Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232001|NCT01453205|O2|Outcome|MEDI-551 4 mg/kg + ICE/DHAP|Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232278|NCT01452347|O1|Outcome|Observed|This includes the observed Ctrough,ss value for all patients in the pharmacokinetic set (PKS) who have a corresponding predicted value.
234942|NCT01444417|O1|Outcome|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
232002|NCT01453205|O1|Outcome|MEDI-551 2 mg/kg + ICE/DHAP|Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232003|NCT01453205|O2|Outcome|MEDI-551 4 mg/kg + ICE/DHAP|Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232004|NCT01453205|O1|Outcome|MEDI-551 2 mg/kg + ICE/DHAP|Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232005|NCT01453205|O3|Outcome|MEDI-551 4 mg/kg + ICE/DHAP|Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232006|NCT01453205|O2|Outcome|MEDI-551 2 mg/kg + ICE/DHAP|Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232007|NCT01453205|O1|Outcome|Rituximab+ ICE/DHAP|Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232008|NCT01453205|O3|Outcome|MEDI-551 4 mg/kg + ICE/DHAP|Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232009|NCT01453205|O2|Outcome|MEDI-551 2 mg/kg + ICE/DHAP|Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232185|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232010|NCT01453205|O1|Outcome|Rituximab+ ICE/DHAP|Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232011|NCT01453205|O3|Outcome|MEDI-551 4 mg/kg + ICE/DHAP|Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232012|NCT01453205|O2|Outcome|MEDI-551 2 mg/kg + ICE/DHAP|Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232013|NCT01453205|O1|Outcome|Rituximab+ ICE/DHAP|Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232014|NCT01453205|O3|Outcome|MEDI-551 4 mg/kg + ICE/DHAP|Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232015|NCT01453205|O2|Outcome|MEDI-551 2 mg/kg + ICE/DHAP|Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232016|NCT01453205|O1|Outcome|Rituximab+ ICE/DHAP|Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232017|NCT01453205|O1|Outcome|MEDI-551|Participants were received MEDI-551 2 mg/kg or 4 mg/kg by IV infusion. Recommended MEDI-551 dose was selected based on the DMC reviews.
232018|NCT01453205|O3|Outcome|MEDI-551 4 mg/kg + ICE/DHAP|Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232019|NCT01453205|O2|Outcome|MEDI-551 2 mg/kg + ICE/DHAP|Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232020|NCT01453205|O1|Outcome|Rituximab+ ICE/DHAP|Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232021|NCT01453205|O3|Outcome|MEDI-551 4 mg/kg + ICE/DHAP|Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232022|NCT01453205|O2|Outcome|MEDI-551 2 mg/kg + ICE/DHAP|Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232023|NCT01453205|O1|Outcome|Rituximab+ ICE/DHAP|Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232024|NCT01453205|O3|Outcome|MEDI-551 4 mg/kg + ICE/DHAP|Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232025|NCT01453205|O2|Outcome|MEDI-551 2 mg/kg + ICE/DHAP|Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232026|NCT01453205|O1|Outcome|Rituximab+ ICE/DHAP|Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232279|NCT01452347|E2|Reported Event|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
232027|NCT01453205|O3|Outcome|MEDI-551 4 mg/kg + ICE/DHAP|Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232028|NCT01453205|O2|Outcome|MEDI-551 2 mg/kg + ICE/DHAP|Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232029|NCT01453205|O1|Outcome|Rituximab+ ICE/DHAP|Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232030|NCT01453205|O3|Outcome|MEDI-551 4 mg/kg + ICE/DHAP|Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232031|NCT01453205|O2|Outcome|MEDI-551 2 mg/kg + ICE/DHAP|Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232032|NCT01453205|O1|Outcome|Rituximab+ ICE/DHAP|Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232033|NCT01453205|O3|Outcome|MEDI-551 4 mg/kg + ICE/DHAP|Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232034|NCT01453205|O2|Outcome|MEDI-551 2 mg/kg + ICE/DHAP|Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232186|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232035|NCT01453205|O1|Outcome|Rituximab+ ICE/DHAP|Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232036|NCT01453205|O3|Outcome|MEDI-551 4 mg/kg + ICE/DHAP|Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232037|NCT01453205|O2|Outcome|MEDI-551 2 mg/kg + ICE/DHAP|Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232038|NCT01453205|O1|Outcome|Rituximab+ ICE/DHAP|Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232039|NCT01453205|O3|Outcome|MEDI-551 4 mg/kg + ICE/DHAP|Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232040|NCT01453205|O2|Outcome|MEDI-551 2 mg/kg + ICE/DHAP|Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232041|NCT01453205|O1|Outcome|Rituximab+ ICE/DHAP|Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232042|NCT01453205|E3|Reported Event|MEDI-551 4 mg/kg + ICE/DHAP|Participants received MEDI-551 (4 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (4 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232235|NCT01452854|P1|Participant Flow|Cancer|The study cohort will include adult women of childbearing potential with a diagnosis of low grade glioma (WHO grade II) who are being treated with low doses of Temozolomide (Temodar).
232043|NCT01453205|E2|Reported Event|MEDI-551 2 mg/kg + ICE/DHAP|Participants received MEDI-551 (2 mg/kg) in combination with ICE or DHAP for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). MEDI-551 (2 mg/kg) was administered IV on 7 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of MEDI-551, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of MEDI-551, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232044|NCT01453205|E1|Reported Event|Rituximab+ ICE/DHAP|Participants received Rituximab in combination with ifosfamide + carboplatin + etoposide (ICE) or dexamethasone + cisplatin + cytarabine (DHAP) for 3 cycles (21-day cycles) and were followed until end of the study (36 months after the date of randomization for last participant, or date the sponsor stops the trial, whichever occurs first). Rituximab (375 mg/m^2) was administered intravenous (IV) on 2 days before the start of Cycle 1 and on Day 1 of each cycle. After completion of rituximab, IV infusion of ICE as: ifosfamide 5 g/ m^2 continuously for 24 hours with mesna on Day 2; carboplatin AUC=5 mg/mL x min (800 mg maximum) on Day 2; etoposide 100 mg/ m^2 on Days 1, 2, and 3 in 21-day cycles. After completion of rituximab, IV infusion of DHAP as: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m^2 continuously for 24 hours on Day 1; cytarabine 2 g/m^2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
232045|NCT01453166|B4|Baseline|Total|Total of all reporting groups
232046|NCT01453166|B3|Baseline|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
232047|NCT01453166|B2|Baseline|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
232048|NCT01453166|B1|Baseline|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
232049|NCT01453166|P3|Participant Flow|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
232050|NCT01453166|P2|Participant Flow|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
232051|NCT01453166|P1|Participant Flow|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
232052|NCT01453166|O3|Outcome|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
232053|NCT01453166|O2|Outcome|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
232054|NCT01453166|O1|Outcome|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
232553|NCT01451554|O1|Outcome|Portion Control Intervention|Individuals will be given a portion control plate and dietary counseling
232055|NCT01453166|O3|Outcome|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
232056|NCT01453166|O2|Outcome|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
232057|NCT01453166|O1|Outcome|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
232058|NCT01453166|O3|Outcome|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
232059|NCT01453166|O2|Outcome|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
232060|NCT01453166|O1|Outcome|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
232061|NCT01453166|O3|Outcome|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
232062|NCT01453166|O2|Outcome|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
232063|NCT01453166|O1|Outcome|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
232064|NCT01453166|O3|Outcome|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
232065|NCT01453166|O2|Outcome|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
232066|NCT01453166|O1|Outcome|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
232236|NCT01452854|O1|Outcome|Cancer|The study cohort will include adult women of childbearing potential with a diagnosis of low grade glioma (WHO grade II) who are being treated with low doses of Temozolomide (Temodar).
232067|NCT01453166|E3|Reported Event|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
232068|NCT01453166|E2|Reported Event|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
232069|NCT01453166|E1|Reported Event|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
232070|NCT01453075|B3|Baseline|Total|Total of all reporting groups
232071|NCT01453075|B2|Baseline|Arm 2: Placebo|"Assigned patients will receiving matching placebo twice daily~Placebo: Matching placebo twice daily"
232072|NCT01453075|B1|Baseline|Arm 1: Valacyclovir|"Assigned patients will take 1.5 mg po valacyclovir twice daily~Valacyclovir: Valacyclovir 1.5 mg po bid"
232073|NCT01453075|P2|Participant Flow|Arm 2: Placebo|"Assigned patients will receiving matching placebo twice daily~Placebo: Matching placebo twice daily"
232074|NCT01453075|P1|Participant Flow|Arm 1: Valacyclovir|"Assigned patients will take 1.5 mg po valacyclovir twice daily~Valacyclovir: Valacyclovir 1.5 mg po bid"
232075|NCT01453075|O2|Outcome|Arm 2: Placebo|"Assigned patients will receiving matching placebo twice daily~Placebo: Matching placebo twice daily"
232076|NCT01453075|O1|Outcome|Arm 1: Valacyclovir|"Assigned patients will take 1.5 mg po valacyclovir twice daily~Valacyclovir: Valacyclovir 1.5 mg po bid"
232077|NCT01453075|E2|Reported Event|Arm 2: Placebo|"Assigned patients will receiving matching placebo twice daily~Placebo: Matching placebo twice daily"
232078|NCT01453075|E1|Reported Event|Arm 1: Valacyclovir|"Assigned patients will take 1.5 mg po valacyclovir twice daily~Valacyclovir: Valacyclovir 1.5 mg po bid"
232079|NCT01453049|B3|Baseline|Total|Total of all reporting groups
232080|NCT01453049|B2|Baseline|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232081|NCT01453049|B1|Baseline|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232082|NCT01453049|P2|Participant Flow|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232083|NCT01453049|P1|Participant Flow|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232084|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232085|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232086|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232157|NCT01453036|P2|Participant Flow|Mutation Test Group|Mutation test group is composed of two groups, clarithromycin group and metronidazole group Clarithromycin subgroup ; no point mutation at 23S rRNA apply clarithromycin 500 mg bid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Metronidazole subgroup ; point mutation at 23S rRNA apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
232087|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232088|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232089|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232090|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232091|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232092|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232093|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232094|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232095|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232096|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232097|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232098|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232099|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232158|NCT01453036|P1|Participant Flow|Conventional AOC Group|The investigators do not perform mutation test in the conventional group apply amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks
232100|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232101|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232102|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232103|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232104|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232105|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232106|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232107|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232108|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232109|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232110|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232111|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232112|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232126|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232113|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232114|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232115|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232116|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232117|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232118|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232119|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232120|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232121|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232122|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232123|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232124|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232125|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232156|NCT01453036|P3|Participant Flow|Convential AOM Group|The investigators do not perform mutation test in the conventional group apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
232127|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232128|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232129|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232130|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232131|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232132|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232133|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232134|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232135|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232136|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232137|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232138|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232139|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232159|NCT01453036|O3|Outcome|Convential AOM Group|The investigators do not perform mutation test in the conventional group apply amoxicillin 1 g, bid , rabeprazole 20 mg bid, metronidazole 500mg tid during 1weeks
232140|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232141|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232142|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232143|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232144|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232145|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232146|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232147|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232148|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232149|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232150|NCT01453049|E2|Reported Event|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232151|NCT01453049|E1|Reported Event|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
232152|NCT01453036|B4|Baseline|Total|Total of all reporting groups
232153|NCT01453036|B3|Baseline|Convential AOM Group|The investigators do not perform mutation test in the conventional group apply amoxicillin 1 g, bid , rabeprazole 20 mg bid, metronidazole 500mg tid during 1weeks
232154|NCT01453036|B2|Baseline|Mutation Test Group|Mutation test group is composed of two groups, clarithromycin group and metronidazole group Clarithromycin subgroup ; no point mutation at 23S rRNA apply clarithromycin 500 mg bid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Metronidazole subgroup ; point mutation at 23S rRNA apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
232155|NCT01453036|B1|Baseline|Convential AOC Group|amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks
232160|NCT01453036|O2|Outcome|Mutation Test Group|Mutation test group is composed of two groups, clarithromycin group and metronidazole group Clarithromycin subgroup ; no point mutation at 23S rRNA apply clarithromycin 500 mg bid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Metronidazole subgroup ; point mutation at 23S rRNA apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
232161|NCT01453036|O1|Outcome|Convential AOC Group|amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks
232162|NCT01453036|E3|Reported Event|Mutation Test Group|
232163|NCT01453036|E2|Reported Event|Convential AOM Group|
232164|NCT01453036|E1|Reported Event|Convential AOC Group|amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks
232165|NCT01453023|B1|Baseline|FF 100 µg/VI 25 µg and FF 100 µg in TPs 1 and 2|All participants who received FF 100 µg/VI 25 µg in Treatment Period 1 and FF 100 µg in Treatment Period 2 or FF 100 µg in Treatment Period 1 and FF 100 µg/VI 25 µg in Treatment Period 2. The first 14-day treatment period was followed by a washout period of at least 7 days. Inhaled FF 100 µg/VI 25 µg and FF 100 µg were administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler.
232166|NCT01453023|P2|Participant Flow|FF 100 µg in TP 1 and FF 100 µg/VI 25 µg in TP 2|Participants received FF 100 µg in Treatment Period 1 and FF 100 µg/VI 25 µg in Treatment Period 2. The first 14-day treatment period was followed by a washout period of at least 7 days. Inhaled FF 100 µg/VI 25 µg and FF 100 µg were administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler.
232167|NCT01453023|P1|Participant Flow|FF 100 µg/VI 25 µg in TP 1 and FF 100 µg in TP 2|Participants received fluticasone furoate (FF) 100 micrograms (µg)/Vilanterol (VI) 25 µg in Treatment Period 1 and FF 100 µg in Treatment Period 2. The first 14-day treatment period was followed by a washout period of at least 7 days. Inhaled FF 100 µg/VI 25 µg and FF 100 µg were administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler.
232168|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232169|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232170|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232171|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232172|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232173|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232174|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232175|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232176|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232177|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232178|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232179|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232180|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232181|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232182|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232183|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232184|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232187|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232188|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232189|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232190|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232191|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232192|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232193|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232194|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232195|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232196|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232197|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232198|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232199|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232200|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232201|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232202|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232203|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232204|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232205|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232206|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232207|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232208|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232209|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232210|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
261455|NCT01355523|E1|Reported Event|Melatonin|6 mg oral melatonin daily
232211|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232212|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232213|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232214|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232215|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232216|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232217|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232218|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232219|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232220|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232221|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232222|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232223|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232224|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232225|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232226|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232227|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232228|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232229|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232230|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232231|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232232|NCT01453023|E2|Reported Event|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232233|NCT01453023|E1|Reported Event|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
232234|NCT01452854|B1|Baseline|Cancer|The study cohort will include adult women of childbearing potential with a diagnosis of low grade glioma (WHO grade II) who are being treated with low doses of Temozolomide (Temodar).
232554|NCT01451554|E2|Reported Event|Usual Care|Provided with self-help booklets on diet and exercise.
232237|NCT01452854|E1|Reported Event|Cancer|"The study cohort will include adult women of childbearing potential with a diagnosis of low grade glioma (WHO grade II) who are being treated with low doses of Temozolomide (Temodar).~Low recruitment necessitated the closing of the study. No results available."
232238|NCT01452529|B3|Baseline|Total|Total of all reporting groups
232239|NCT01452529|B2|Baseline|Placebo|"Placebo to match hydrocodone bitartrate once daily tablets~Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily"
232240|NCT01452529|B1|Baseline|Hydrocodone Bitartrate|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
232241|NCT01452529|P3|Participant Flow|Placebo|"Placebo to match hydrocodone bitartrate once daily tablets~Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily"
232242|NCT01452529|P2|Participant Flow|Hydrocodone Bitartrate|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
232243|NCT01452529|P1|Participant Flow|Open-label Run-in Dose-titration Period Hydrocodone Bitartrate|The open-label run-in dose-titration period was designed to assess subjects qualification for randomization
232244|NCT01452529|O2|Outcome|Placebo|"Placebo to match hydrocodone bitartrate once daily tablets~Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily"
232245|NCT01452529|O1|Outcome|Hydrocodone Bitartrate|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
232246|NCT01452529|O2|Outcome|Placebo|"Placebo to match hydrocodone bitartrate once daily tablets~Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily"
232247|NCT01452529|O1|Outcome|Hydrocodone Bitartrate|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
232248|NCT01452529|O2|Outcome|Placebo|"Placebo to match hydrocodone bitartrate once daily tablets~Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily"
232249|NCT01452529|O1|Outcome|Hydrocodone Bitartrate|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
232250|NCT01452529|O2|Outcome|Placebo|"Placebo to match hydrocodone bitartrate once daily tablets~Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily"
232251|NCT01452529|O1|Outcome|Hydrocodone Bitartrate|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
232252|NCT01452529|O2|Outcome|Placebo|"Placebo to match hydrocodone bitartrate once daily tablets~Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily"
232253|NCT01452529|O1|Outcome|Hydrocodone Bitartrate|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
232254|NCT01452529|E3|Reported Event|Placebo|"Placebo to match hydrocodone bitartrate once daily tablets~Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily"
232255|NCT01452529|E2|Reported Event|Hydrocodone Bitartrate|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
232256|NCT01452529|E1|Reported Event|Open-label Run-in Dose-titration Period Hydrocodone Bitartrate|The open-label run-in dose-titration period was designed to assess subjects' qualification for randomization
232257|NCT01452425|B1|Baseline|Tourniquet|No adverse event
232258|NCT01452425|P1|Participant Flow|Tourniquet|"Inflation of a tourniquet~Tourniquet: Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion"
232259|NCT01452425|O1|Outcome|Tourniquet|
232260|NCT01452425|O1|Outcome|Tourniquet|"Inflation of a tourniquet~Tourniquet: Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion"
232261|NCT01452425|E1|Reported Event|Tourniquet|No adverse event
232262|NCT01452347|B3|Baseline|Total|Total of all reporting groups
232263|NCT01452347|B2|Baseline|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
232264|NCT01452347|B1|Baseline|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily
232265|NCT01452347|P2|Participant Flow|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
232266|NCT01452347|P1|Participant Flow|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily
232267|NCT01452347|O1|Outcome|Patients Evaluated|All patients treated orally with either 150mg, 220mg or 300mg of dabigatran etexilate (DE) twice daily.
232268|NCT01452347|O1|Outcome|Patients Evaluated|All patients treated orally with either 150mg, 220mg or 300mg of dabigatran etexilate (DE) twice daily.
232269|NCT01452347|O1|Outcome|Patients Evaluated|All patients treated orally with either 150mg, 220mg or 300mg of dabigatran etexilate (DE) twice daily.
232270|NCT01452347|O1|Outcome|Patients Evaluated|All patients treated orally with either 150mg, 220mg or 300mg of dabigatran etexilate (DE) twice daily.
232271|NCT01452347|O2|Outcome|Predicted|This includes the predicted Ctrough,ss value for all patients in the PKS who have a corresponding observed value.
232272|NCT01452347|O1|Outcome|Observed|This includes the observed Ctrough,ss value for all patients in the PKS who have a corresponding predicted value.
232280|NCT01452347|E1|Reported Event|Dabigatran Etexilate|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily
232281|NCT01452269|B3|Baseline|Total|Total of all reporting groups
232282|NCT01452269|B2|Baseline|Delayed Intervention Group|"This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
232283|NCT01452269|B1|Baseline|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
232284|NCT01452269|P2|Participant Flow|Delayed Intervention Group|"This arm received the Group intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
232285|NCT01452269|P1|Participant Flow|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
232286|NCT01452269|O2|Outcome|Delayed Intervention Group|"This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
232287|NCT01452269|O1|Outcome|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
232288|NCT01452269|O2|Outcome|Delayed Intervention Group|"This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
232303|NCT01452152|O1|Outcome|Genotype-directed, Clopidogrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.~clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year"
232289|NCT01452269|O1|Outcome|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
232290|NCT01452269|O2|Outcome|Delayed Intervention Group|"This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
232291|NCT01452269|O1|Outcome|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
232292|NCT01452269|E2|Reported Event|Delayed Intervention Group|"This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
232293|NCT01452269|E1|Reported Event|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
232294|NCT01452152|B4|Baseline|Total|Total of all reporting groups
232295|NCT01452152|B3|Baseline|Standard of Care|Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
232296|NCT01452152|B2|Baseline|Genotype-directed, Prasugrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.~prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year"
232297|NCT01452152|B1|Baseline|Genotype-directed, Clopidogrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.~clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year"
232298|NCT01452152|P3|Participant Flow|Standard of Care|Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
232299|NCT01452152|P2|Participant Flow|Genotype-directed, Prasugrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.~prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year"
232300|NCT01452152|P1|Participant Flow|Genotype-directed, Clopidogrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.~clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year"
232301|NCT01452152|O3|Outcome|Standard of Care|Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
232302|NCT01452152|O2|Outcome|Genotype-directed, Prasugrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.~prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year"
232304|NCT01452152|O3|Outcome|Standard of Care|Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
232305|NCT01452152|O2|Outcome|Genotype-directed, Prasugrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.~prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year"
232306|NCT01452152|O1|Outcome|Genotype-directed, Clopidogrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.~clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year"
232307|NCT01452152|O3|Outcome|Standard of Care|Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
232308|NCT01452152|O2|Outcome|Genotype-directed, Prasugrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.~prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year"
232309|NCT01452152|O1|Outcome|Genotype-directed, Clopidogrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.~clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year"
232310|NCT01452152|O3|Outcome|Standard of Care|Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
232311|NCT01452152|O2|Outcome|Genotype-directed, Prasugrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.~prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year"
232312|NCT01452152|O1|Outcome|Genotype-directed, Clopidogrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.~clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year"
232313|NCT01452152|O3|Outcome|Standard of Care|Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
232314|NCT01452152|O2|Outcome|Genotype-directed, Prasugrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.~prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year"
232315|NCT01452152|O1|Outcome|Genotype-directed, Clopidogrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.~clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year"
232316|NCT01452152|O3|Outcome|Standard of Care|Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
232317|NCT01452152|O2|Outcome|Genotype-directed, Prasugrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.~prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year"
232318|NCT01452152|O1|Outcome|Genotype-directed, Clopidogrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.~clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year"
232319|NCT01452152|E3|Reported Event|Standard of Care|Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
232320|NCT01452152|E2|Reported Event|Genotype-directed, Prasugrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.~prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year"
232321|NCT01452152|E1|Reported Event|Genotype-directed, Clopidogrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.~clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year"
232322|NCT01452126|B1|Baseline|Ropivacaine|Each patient received ropivacaine-based nerve blockade at a fixed volume, with concentration determined per protocol
232323|NCT01452126|P1|Participant Flow|Ropivacaine|"Sequential allocation of ropivacaine concentration depending on the success or failure of surgical anesthesia of the previous patient~Ropivacaine concentration: Single shot preoperative perineural injection of ropivacaine to achieve surgical anesthesia. The concentration of ropivacaine is lowered by 0.05% after every successful surgical anesthesia specific to that block and raised by 0.05% after every unsuccessful surgical anesthesia specific to that block"
232324|NCT01452126|O1|Outcome|Ropivacaine|"Sequential allocation of ropivacaine concentration depending on the success or failure of surgical anesthesia of the previous patient~Ropivacaine concentration: Single shot preoperative perineural injection of ropivacaine to achieve surgical anesthesia. The concentration of ropivacaine is lowered by 0.05% after every successful surgical anesthesia specific to that block and raised by 0.05% after every unsuccessful surgical anesthesia specific to that block"
232325|NCT01452126|O4|Outcome|Popliteal Nerve Block|Ropivacaine-based blockade of the popliteal nerve, with concentration per protocol.
232326|NCT01452126|O3|Outcome|Infraclavicular Blockade|Ropivacaine-based blockade of the brachial plexus nerves via an infraclavicular approach, with concentration per protocol.
232327|NCT01452126|O2|Outcome|Supraclavicular Blockade|Ropivacaine-based blockade of the brachial plexus nerves via a supraclavicular approach, with concentration per protocol.
232328|NCT01452126|O1|Outcome|Femoral Nerve Block|Ropivacaine-based blockade of the femoral nerve, with concentration per protocol.
232359|NCT01451983|P1|Participant Flow|ASD With PTEN|Individuals with autism spectrum disorder who are also found to have a PTEN mutation.
261456|NCT01355484|B3|Baseline|Total|Total of all reporting groups
232329|NCT01452126|E1|Reported Event|Ropivacaine|"Sequential allocation of ropivacaine concentration depending on the success or failure of surgical anesthesia of the previous patient~Ropivacaine concentration: Single shot preoperative perineural injection of ropivacaine to achieve surgical anesthesia. The concentration of ropivacaine is lowered by 0.05% after every successful surgical anesthesia specific to that block and raised by 0.05% after every unsuccessful surgical anesthesia specific to that block"
232330|NCT01451996|B5|Baseline|Total|Total of all reporting groups
232331|NCT01451996|B4|Baseline|Zyrtec Ads, Allergy-|"Subject, without allergies, will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.~Claritin: Subject will be given 10mg Claritin tablet."
232332|NCT01451996|B3|Baseline|Claritin Ads, Allergy-|"Subject, without allergies, will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.~Claritin: Subject will be given 10mg Claritin tablet."
232333|NCT01451996|B2|Baseline|Zyrtec Ads, Allergy+|"Subject, with positive skin test to at least one common allergen (grass, trees, mold, dust mites, ragweed, cats), will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.~Claritin: Subject will be given 10mg Claritin tablet."
232334|NCT01451996|B1|Baseline|Claritin Ads, Allergy+|"Subject, with positive skin test to at least one common allergen (grass, trees, mold, dust mites, ragweed, cats), will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.~Claritin: Subject will be given 10mg Claritin tablet."
232335|NCT01451996|P4|Participant Flow|Zyrtec Ads, Allergy-|"Subject, without allergies, will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.~Claritin: Subject will be given 10mg Claritin tablet."
232336|NCT01451996|P3|Participant Flow|Claritin Ads, Allergy-|"Subject, without allergies, will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.~Claritin: Subject will be given 10mg Claritin tablet."
232337|NCT01451996|P2|Participant Flow|Zyrtec Ads, Allergy+|"Subject, with positive skin test to at least one common allergen (grass, trees, mold, dust mites, ragweed, cats), will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.~Claritin: Subject will be given 10mg Claritin tablet."
232338|NCT01451996|P1|Participant Flow|Claritin Ads, Allergy+|"Subject, with positive skin test to at least one common allergen (grass, trees, mold, dust mites, ragweed, cats), will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.~Claritin: Subject will be given 10mg Claritin tablet."
232339|NCT01451996|O4|Outcome|Zyrtec Ads, Allergy-|"Subject, without allergies, will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.~Claritin: Subject will be given 10mg Claritin tablet."
232340|NCT01451996|O3|Outcome|Claritin Ads, Allergy-|"Subject, without allergies, will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.~Claritin: Subject will be given 10mg Claritin tablet."
232341|NCT01451996|O2|Outcome|Zyrtec Ads, Allergy+|"Subject, with positive skin test to at least one common allergen (grass, trees, mold, dust mites, ragweed, cats), will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.~Claritin: Subject will be given 10mg Claritin tablet."
232342|NCT01451996|O1|Outcome|Claritin Ads, Allergy+|"Subject, with positive skin test to at least one common allergen (grass, trees, mold, dust mites, ragweed, cats), will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.~Claritin: Subject will be given 10mg Claritin tablet."
232343|NCT01451996|O4|Outcome|Zyrtec Ads, Allergy-|"Subject, without allergies, will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.~Claritin: Subject will be given 10mg Claritin tablet."
232344|NCT01451996|O3|Outcome|Claritin Ads, Allergy-|"Subject, without allergies, will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.~Claritin: Subject will be given 10mg Claritin tablet."
232345|NCT01451996|O2|Outcome|Zyrtec Ads, Allergy+|"Subject, with positive skin test to at least one common allergen (grass, trees, mold, dust mites, ragweed, cats), will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.~Claritin: Subject will be given 10mg Claritin tablet."
232346|NCT01451996|O1|Outcome|Claritin Ads, Allergy+|"Subject, with positive skin test to at least one common allergen (grass, trees, mold, dust mites, ragweed, cats), will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.~Claritin: Subject will be given 10mg Claritin tablet."
232347|NCT01451996|E4|Reported Event|Zyrtec Ads, Allergy-|"Subject, without allergies, will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.~Claritin: Subject will be given 10mg Claritin tablet."
232348|NCT01451996|E3|Reported Event|Claritin Ads, Allergy-|"Subject, without allergies, will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.~Claritin: Subject will be given 10mg Claritin tablet."
232349|NCT01451996|E2|Reported Event|Zyrtec Ads, Allergy+|"Subject, with positive skin test to at least one common allergen (grass, trees, mold, dust mites, ragweed, cats), will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.~Claritin: Subject will be given 10mg Claritin tablet."
232350|NCT01451996|E1|Reported Event|Claritin Ads, Allergy+|"Subject, with positive skin test to at least one common allergen (grass, trees, mold, dust mites, ragweed, cats), will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.~Claritin: Subject will be given 10mg Claritin tablet."
232351|NCT01451983|B5|Baseline|Total|Total of all reporting groups
232352|NCT01451983|B4|Baseline|Siblings|Siblings of individuals with autism spectrum disorders.
232353|NCT01451983|B3|Baseline|ASD no PTEN no Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation without a large head circumference.
232354|NCT01451983|B2|Baseline|ASD no PTEN Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation with a large head circumference.
232355|NCT01451983|B1|Baseline|ASD With PTEN|Individuals with autism spectrum disorder who are also found to have a PTEN mutation.
232356|NCT01451983|P4|Participant Flow|Siblings|Siblings of individuals with autism spectrum disorders.
232357|NCT01451983|P3|Participant Flow|ASD no PTEN no Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation without a large head circumference.
232358|NCT01451983|P2|Participant Flow|ASD no PTEN Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation with a large head circumference.
232361|NCT01451983|O3|Outcome|ASD no PTEN no Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation without a large head circumference.
232362|NCT01451983|O2|Outcome|ASD no PTEN Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation with a large head circumference.
232363|NCT01451983|O1|Outcome|ASD With PTEN|Individuals with autism spectrum disorder who are also found to have a PTEN mutation.
232364|NCT01451983|E4|Reported Event|Siblings|Siblings of individuals with autism spectrum disorders.
232365|NCT01451983|E3|Reported Event|ASD no PTEN no Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation without a large head circumference.
232366|NCT01451983|E2|Reported Event|ASD no PTEN Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation with a large head circumference.
232367|NCT01451983|E1|Reported Event|ASD With PTEN|Individuals with autism spectrum disorder who are also found to have a PTEN mutation.
232368|NCT01451931|B4|Baseline|Total|Total of all reporting groups
232369|NCT01451931|B3|Baseline|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
232370|NCT01451931|B2|Baseline|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
232371|NCT01451931|B1|Baseline|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
232372|NCT01451931|P3|Participant Flow|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
232373|NCT01451931|P2|Participant Flow|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
232374|NCT01451931|P1|Participant Flow|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
232375|NCT01451931|O3|Outcome|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
232376|NCT01451931|O2|Outcome|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
232377|NCT01451931|O1|Outcome|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
232378|NCT01451931|O3|Outcome|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
232379|NCT01451931|O2|Outcome|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
232380|NCT01451931|O1|Outcome|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
232381|NCT01451931|O3|Outcome|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
232382|NCT01451931|O2|Outcome|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
232383|NCT01451931|O1|Outcome|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
232384|NCT01451931|O3|Outcome|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
232385|NCT01451931|O2|Outcome|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
232386|NCT01451931|O1|Outcome|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
232387|NCT01451931|O3|Outcome|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
232388|NCT01451931|O2|Outcome|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
232389|NCT01451931|O1|Outcome|Point-of-care Ultrasound|"Patient with suspected urolithiasis will receive ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
232390|NCT01451931|E3|Reported Event|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
232391|NCT01451931|E2|Reported Event|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
232555|NCT01451554|E1|Reported Event|Portion Control Intervention|Individuals will be given a portion control plate and dietary counseling
232392|NCT01451931|E1|Reported Event|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
232393|NCT01451814|B3|Baseline|Total|Total of all reporting groups
232394|NCT01451814|B2|Baseline|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition~Nicotine polacrilex: 8 weeks of nicotine patch~Relaxation training: Instructions in progressive muscle relaxation~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
232395|NCT01451814|B1|Baseline|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Nicotine polacrilex: 8 weeks of nicotine patch~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
232396|NCT01451814|P2|Participant Flow|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition~Nicotine polacrilex: 8 weeks of nicotine patch~Relaxation training: Instructions in progressive muscle relaxation~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
232397|NCT01451814|P1|Participant Flow|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Nicotine polacrilex: 8 weeks of nicotine patch~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
232398|NCT01451814|O2|Outcome|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition~Nicotine polacrilex: 8 weeks of nicotine patch~Relaxation training: Instructions in progressive muscle relaxation~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
232399|NCT01451814|O1|Outcome|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Nicotine polacrilex: 8 weeks of nicotine patch~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
232400|NCT01451814|O2|Outcome|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition~Nicotine polacrilex: 8 weeks of nicotine patch~Relaxation training: Instructions in progressive muscle relaxation~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
232401|NCT01451814|O1|Outcome|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Nicotine polacrilex: 8 weeks of nicotine patch~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
232402|NCT01451814|O2|Outcome|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition~Nicotine polacrilex: 8 weeks of nicotine patch~Relaxation training: Instructions in progressive muscle relaxation~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
232403|NCT01451814|O1|Outcome|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Nicotine polacrilex: 8 weeks of nicotine patch~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
232404|NCT01451814|E2|Reported Event|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition~Nicotine polacrilex: 8 weeks of nicotine patch~Relaxation training: Instructions in progressive muscle relaxation~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
232441|NCT01451749|P2|Participant Flow|Donepezil|"Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.~Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
232442|NCT01451749|P1|Participant Flow|Shenwu Capsule|Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months
232556|NCT01451541|B4|Baseline|Total|Total of all reporting groups
263092|NCT01350401|O3|Outcome|Subject 2 - Manufactured Product|
232405|NCT01451814|E1|Reported Event|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Nicotine polacrilex: 8 weeks of nicotine patch~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
232406|NCT01451775|B1|Baseline|Study Overall|Total number of patients randomised and treated in the study. This was a randomised 3 period crossover trial. 18 patients were randomised to one of six treatment sequences and treated. The trial was open label with washout periods of at least 7 days between treatments.
232407|NCT01451775|P6|Participant Flow|Empa 10mg Fasted / Empa 25mg Fed / Empa 25mg Fasted|"Patients were administered three treatments in the following order:~A single dose of 10 mg empa after an overnight fast of at least 10 hours.~A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast~A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours."
232408|NCT01451775|P5|Participant Flow|Empa 10mg Fasted / Empa 25mg Fasted / Empa 25mg Fed|"Patients were administered three treatments in the following order:~A single dose of 10 mg empa after an overnight fast of at least 10 hours.~A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.~A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast"
232409|NCT01451775|P4|Participant Flow|Empa 25mg Fed / Empa 10mg Fasted / Empa 25mg Fasted|"Patients were administered three treatments in the following order:~A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast~A single dose of 10 mg empa after an overnight fast of at least 10 hours.~A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours."
232410|NCT01451775|P3|Participant Flow|Empa 25mg Fed / Empa 25mg Fasted / Empa 10mg Fasted|"Patients were administered three treatments in the following order:~A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast~A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.~A single dose of 10 mg empa after an overnight fast of at least 10 hours."
232411|NCT01451775|P2|Participant Flow|Empa 25mg Fasted / Empa 10mg Fasted / Empa 25mg Fed|"Patients were administered three treatments in the following order:~A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.~A single dose of 10 mg empa after an overnight fast of at least 10 hours.~A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast"
232412|NCT01451775|P1|Participant Flow|Empa 25mg Fasted / Empa 25mg Fed / Empa 10mg Fasted|"Patients were administered three treatments in the following order:~A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.~A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast~A single dose of 10 mg empa after an overnight fast of at least 10 hours."
232413|NCT01451775|O3|Outcome|Empa 10 mg Fasted|A single dose of 10 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
232414|NCT01451775|O2|Outcome|Empa 25 mg Fed|A single dose of 25 mg empagliflozin (empa) after a standardised high-fat, high-caloric breakfast.
232415|NCT01451775|O1|Outcome|Empa 25 mg Fasted|A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
232416|NCT01451775|O3|Outcome|Empa 10 mg Fasted|A single dose of 10 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
232417|NCT01451775|O2|Outcome|Empa 25 mg Fed|A single dose of 25 mg empagliflozin (empa) after a standardised high-fat, high-caloric breakfast.
232418|NCT01451775|O1|Outcome|Empa 25 mg Fasted|A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
232419|NCT01451775|O3|Outcome|Empa 10 mg Fasted|A single dose of 10 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
232420|NCT01451775|O2|Outcome|Empa 25 mg Fed|A single dose of 25 mg empagliflozin (empa) after a standardised high-fat, high-caloric breakfast.
232421|NCT01451775|O1|Outcome|Empa 25 mg Fasted|A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
232422|NCT01451775|E3|Reported Event|Empa 10 mg Fasted|A single dose of 10 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
232423|NCT01451775|E2|Reported Event|Empa 25 mg Fed|A single dose of 25 mg empagliflozin (empa) after a standardised high-fat, high-caloric breakfast.
232424|NCT01451775|E1|Reported Event|Empa 25 mg Fasted|A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
232425|NCT01451762|B4|Baseline|Total|Total of all reporting groups
232426|NCT01451762|B3|Baseline|50 mg Diphenhydramine IV|50 mg diphenhydramine IV administered before surgery
232427|NCT01451762|B2|Baseline|25 mg Diphenhydramine IV|25 mg diphenhydramine IV administered before surgery
232428|NCT01451762|B1|Baseline|Placebo|.9 normal saline IV
232429|NCT01451762|P3|Participant Flow|50 mg Diphenhydramine IV|50 mg diphenhydramine IV administered before surgery
232430|NCT01451762|P2|Participant Flow|25 mg Diphenhydramine IV|25 mg diphenhydramine IV administered before surgery
232431|NCT01451762|P1|Participant Flow|Placebo|.9 normal saline IV
232432|NCT01451762|O3|Outcome|50 mg Diphenhydramine IV|50 mg diphenhydramine IV administered before surgery
232433|NCT01451762|O2|Outcome|25 mg Diphenhydramine IV|25 mg diphenhydramine IV administered before surgery
232434|NCT01451762|O1|Outcome|Placebo|.9 normal saline IV
232435|NCT01451762|E3|Reported Event|50 mg Diphenhydramine IV|50 mg diphenhydramine IV administered before surgery
232436|NCT01451762|E2|Reported Event|25 mg Diphenhydramine IV|25 mg diphenhydramine IV administered before surgery
232437|NCT01451762|E1|Reported Event|Placebo|.9 normal saline IV
232438|NCT01451749|B3|Baseline|Total|Total of all reporting groups
232439|NCT01451749|B2|Baseline|Donepezil|"Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.~Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
232440|NCT01451749|B1|Baseline|Shenwu Capsule|Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months
232600|NCT01451541|E1|Reported Event|Placebo|Placebo: placebo - one dose per nostril
232443|NCT01451749|O2|Outcome|Donepezil|"1 tablet contains 5 mg of donepezil, 1 tablet/time, 1time/day for 6 months.~Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.~Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
232444|NCT01451749|O1|Outcome|Shenwu Capsule|"1 capsule contains 451 mg of Shenwu extracts. 5 capsules/time, 3 times/day for 6 months.~Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months"
232445|NCT01451749|O2|Outcome|Donepezil|"1 tablet contains 5 mg of donepezil, 1 tablet/time, 1time/day for 6 months.~Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.~Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
232446|NCT01451749|O1|Outcome|Shenwu Capsule|"1 capsule contains 451 mg of Shenwu extracts. 5 capsules/time, 3 times/day for 6 months.~Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months"
232447|NCT01451749|O2|Outcome|Donepezil|"Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.~Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
232448|NCT01451749|O1|Outcome|Shenwu Capsule|Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months
232449|NCT01451749|E2|Reported Event|Donepezil|"1 tablet contains 5 mg of donepezil, 1 tablet/time, 1time/day for 6 months.~Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.~Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
232450|NCT01451749|E1|Reported Event|Shenwu Capsule|"1 capsule contains 451 mg of Shenwu extracts. 5 capsules/time, 3 times/day for 6 months.~Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months"
232451|NCT01451723|B3|Baseline|Total|Total of all reporting groups
232452|NCT01451723|B2|Baseline|Placebo|"Matching placebo capsules.~Placebo: Matching placebo capsules"
232453|NCT01451723|B1|Baseline|Polyphenon E 400mg Twice a Day|"Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.~Polyphenon E: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food."
232454|NCT01451723|P2|Participant Flow|Placebo|"Matching placebo capsules.~Placebo: Matching placebo capsules"
232455|NCT01451723|P1|Participant Flow|Polyphenon E 400mg Twice a Day|"Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.~Polyphenon E: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food."
232456|NCT01451723|O2|Outcome|Placebo|"Matching placebo capsules.~Placebo: Matching placebo capsules"
232457|NCT01451723|O1|Outcome|Polyphenon E 400mg Twice a Day|"Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.~Polyphenon E: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food."
232458|NCT01451723|O2|Outcome|Placebo|"Matching placebo capsules.~Placebo: Matching placebo capsules"
232459|NCT01451723|O1|Outcome|Polyphenon E 400mg Twice a Day|"Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.~Polyphenon E: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food."
232460|NCT01451723|E2|Reported Event|Placebo|"Matching placebo capsules.~Placebo: Matching placebo capsules"
232461|NCT01451723|E1|Reported Event|Polyphenon E 400mg Twice a Day|"Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.~Polyphenon E: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food."
232462|NCT01451645|B3|Baseline|Total|Total of all reporting groups
232463|NCT01451645|B2|Baseline|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
232464|NCT01451645|B1|Baseline|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
232465|NCT01451645|P2|Participant Flow|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
232466|NCT01451645|P1|Participant Flow|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
232467|NCT01451645|O2|Outcome|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
232468|NCT01451645|O1|Outcome|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
232469|NCT01451645|O2|Outcome|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
232470|NCT01451645|O1|Outcome|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
232471|NCT01451645|O2|Outcome|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
232472|NCT01451645|O1|Outcome|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
232473|NCT01451645|O2|Outcome|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
232474|NCT01451645|O1|Outcome|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
232475|NCT01451645|E2|Reported Event|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
232476|NCT01451645|E1|Reported Event|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
232477|NCT01451632|B3|Baseline|Total|Total of all reporting groups
232478|NCT01451632|B2|Baseline|Part 2: MM-121 + Cetuximab + Irinotecan|"increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
232479|NCT01451632|B1|Baseline|Part 1: MM-121 + Cetuximab|"increasing doses of weekly MM-121 + weekly cetuximab~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
232480|NCT01451632|P10|Participant Flow|Part 2: Expansion Cohort|"MM-121: 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
232481|NCT01451632|P9|Participant Flow|Part 2: Cohort 2|"MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
232482|NCT01451632|P8|Participant Flow|Part 2: Cohort 1|"MM-121: 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
232483|NCT01451632|P7|Participant Flow|Part 1: Expansion Cohort|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
232484|NCT01451632|P6|Participant Flow|Part 1: Cohort 4|MM-121: 40 mg/kg one time loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 one-time loading dose followed by 250 mg/m2 maintenance IV QW
232485|NCT01451632|P5|Participant Flow|Part 1: Cohort 3b|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
232486|NCT01451632|P4|Participant Flow|Part 1: Cohort 3a|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
232487|NCT01451632|P3|Participant Flow|Part 1: Cohort 2b|MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
232488|NCT01451632|P2|Participant Flow|Part 1: Cohort 2a|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
232489|NCT01451632|P1|Participant Flow|Part 1: Cohort 1|MM-121: 12 mg/kg IV weekly in 4-week cycles Cetuximab: 400 mg/m2 IV one-time loading dose followed by 200 mg/m2 IV weekly maintenance doses
232490|NCT01451632|O10|Outcome|Part 2: Expansion Cohort|"MM-121: 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
232491|NCT01451632|O9|Outcome|Part 2: Cohort 2|"MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
232492|NCT01451632|O8|Outcome|Part 2: Cohort 1|"MM-121: 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
232493|NCT01451632|O7|Outcome|Part 1: Expansion Cohort|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
232494|NCT01451632|O6|Outcome|Part 1: Cohort 4|MM-121: 40 mg/kg one time loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 one-time loading dose followed by 250 mg/m2 maintenance IV QW
232495|NCT01451632|O5|Outcome|Part 1: Cohort 3b|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
232496|NCT01451632|O4|Outcome|Part 1: Cohort 3a|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
232497|NCT01451632|O3|Outcome|Part 1: Cohort 2b|MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
232498|NCT01451632|O2|Outcome|Part 1: Cohort 2a|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
232499|NCT01451632|O1|Outcome|Part 1: Cohort 1|MM-121: 12 mg/kg IV weekly in 4-week cycles Cetuximab: 400 mg/m2 IV one-time loading dose followed by 200 mg/m2 IV weekly maintenance doses
232500|NCT01451632|O5|Outcome|Part 2: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance doses plus cetuximab 400/250 mg/m2 plus irinotecan 180 mg/m2
232501|NCT01451632|O4|Outcome|Part 2: 20 mg/kg|MM-121: 20 mg/kg plus cetuximab at 400/250 mg/m2 plus irinotecan at 180 mg/m2
232502|NCT01451632|O3|Outcome|Part 1: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance doses Plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
232503|NCT01451632|O2|Outcome|Part 1: 20 mg/kg|MM-121: 20 mg/kg Plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
232504|NCT01451632|O1|Outcome|Part 1: 12 mg/kg|MM-121 mg/kg plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
232505|NCT01451632|O5|Outcome|Part 2: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance doses plus cetuximab 400/250 mg/m2 plus irinotecan 180 mg/m2
232506|NCT01451632|O4|Outcome|Part 2: 20 mg/kg|MM-121: 20 mg/kg plus cetuximab at 400/250 mg/m2 plus irinotecan at 180 mg/m2
232507|NCT01451632|O3|Outcome|Part 1: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance doses Plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
232508|NCT01451632|O2|Outcome|Part 1: 20 mg/kg|MM-121: 20 mg/kg Plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
232509|NCT01451632|O1|Outcome|Part 1: 12 mg/kg|MM-121 mg/kg plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
232510|NCT01451632|O10|Outcome|Part 2: Expansion Cohort|"MM-121: 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
232511|NCT01451632|O9|Outcome|Part 2: Cohort 2|"MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
232512|NCT01451632|O8|Outcome|Part 2: Cohort 1|"MM-121: 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
232513|NCT01451632|O7|Outcome|Part 1: Expansion Cohort|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
232514|NCT01451632|O6|Outcome|Part 1: Cohort 4|MM-121: 40 mg/kg one time loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 one-time loading dose followed by 250 mg/m2 maintenance IV QW
232515|NCT01451632|O5|Outcome|Part 1: Cohort 3b|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
232516|NCT01451632|O4|Outcome|Part 1: Cohort 3a|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
232517|NCT01451632|O3|Outcome|Part 1: Cohort 2b|MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
232518|NCT01451632|O2|Outcome|Part 1: Cohort 2a|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
232802|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
232519|NCT01451632|O1|Outcome|Part 1: Cohort 1|MM-121: 12 mg/kg IV weekly in 4-week cycles Cetuximab: 400 mg/m2 IV one-time loading dose followed by 200 mg/m2 IV weekly maintenance doses
232520|NCT01451632|O2|Outcome|Part 2: MM-121 + Cetuximab + Irinotecan|"increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
232521|NCT01451632|O1|Outcome|Part 1: MM-121 + Cetuximab|"increasing doses of weekly MM-121 + weekly cetuximab~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
232522|NCT01451632|O2|Outcome|Part 2: MM-121 + Cetuximab + Irinotecan|"increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
232523|NCT01451632|O1|Outcome|Part 1: MM-121 + Cetuximab|"increasing doses of weekly MM-121 + weekly cetuximab~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
232524|NCT01451632|O8|Outcome|Part 2: Cohort 2|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W
232525|NCT01451632|O7|Outcome|Part 2: Cohort 1|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W
232526|NCT01451632|O6|Outcome|Part 1: Cohort 4|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
232527|NCT01451632|O5|Outcome|Part 1: Cohort 3b|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
232528|NCT01451632|O4|Outcome|Part 1: Cohort 3a|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
232529|NCT01451632|O3|Outcome|Part 1: Cohort 2b|MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
232530|NCT01451632|O2|Outcome|Part 1: Cohort 2a|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
232531|NCT01451632|O1|Outcome|Part 1: Cohort 1|MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
232532|NCT01451632|E2|Reported Event|Part 2: MM-121 + Cetuximab + Irinotecan|"increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
232533|NCT01451632|E1|Reported Event|Part 1: MM-121 + Cetuximab|"increasing doses of weekly MM-121 + weekly cetuximab~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
232534|NCT01451606|B3|Baseline|Total|Total of all reporting groups
232535|NCT01451606|B2|Baseline|Duloxetine|"The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).~Duloxetine: 30 mg dose once daily, administered orally for 1 week, 60 mg dose once daily, administered orally for 5 weeks, 30 mg dose once daily, administered orally for 1 week"
232536|NCT01451606|B1|Baseline|Placebo Pill|"A pill that looks like the active drug, but does not contain any active ingredients.~Placebo: To serve as placebo for duloxetine. Administration schedule same as for active drug."
232537|NCT01451606|P2|Participant Flow|Duloxetine|"The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).~Duloxetine: 30 mg dose once daily, administered orally for 1 week, 60 mg dose once daily, administered orally for 5 weeks, 30 mg dose once daily, administered orally for 1 week"
232538|NCT01451606|P1|Participant Flow|Placebo Pill|"A pill that looks like the active drug, but does not contain any active ingredients.~Placebo: To serve as placebo for duloxetine. Administration schedule same as for active drug."
232539|NCT01451606|O2|Outcome|Duloxetine|"The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).~Duloxetine: 30 mg dose once daily, administered orally for 1 week, 60 mg dose once daily, administered orally for 5 weeks, 30 mg dose once daily, administered orally for 1 week"
232540|NCT01451606|O1|Outcome|Placebo Pill|"A pill that looks like the active drug, but does not contain any active ingredients.~Placebo: To serve as placebo for duloxetine. Administration schedule same as for active drug."
232541|NCT01451606|O2|Outcome|Duloxetine|"The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).~Duloxetine: 30 mg dose once daily, administered orally for 1 week, 60 mg dose once daily, administered orally for 5 weeks, 30 mg dose once daily, administered orally for 1 week"
232542|NCT01451606|O1|Outcome|Placebo Pill|"A pill that looks like the active drug, but does not contain any active ingredients.~Placebo: To serve as placebo for duloxetine. Administration schedule same as for active drug."
232543|NCT01451606|E2|Reported Event|Duloxetine|"The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).~Duloxetine: 30 mg dose once daily, administered orally for 1 week, 60 mg dose once daily, administered orally for 5 weeks, 30 mg dose once daily, administered orally for 1 week"
232544|NCT01451606|E1|Reported Event|Placebo Pill|"A pill that looks like the active drug, but does not contain any active ingredients.~Placebo: To serve as placebo for duloxetine. Administration schedule same as for active drug."
232545|NCT01451554|B3|Baseline|Total|Total of all reporting groups
232546|NCT01451554|B2|Baseline|Usual Care|Provided with self-help booklets on diet and exercise.
232547|NCT01451554|B1|Baseline|Portion Control Intervention|Individuals will be given a portion control plate and dietary counseling
232548|NCT01451554|P2|Participant Flow|Usual Care|Provided with self-help booklets on diet and exercise.
232549|NCT01451554|P1|Participant Flow|Portion Control Intervention|Individuals will be given a portion control plate and dietary counseling
232550|NCT01451554|O2|Outcome|Usual Care|Provided with self-help booklets on diet and exercise.
232557|NCT01451541|B3|Baseline|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
232558|NCT01451541|B2|Baseline|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
232559|NCT01451541|B1|Baseline|Placebo|Placebo: placebo - one dose per nostril
232560|NCT01451541|P3|Participant Flow|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
232561|NCT01451541|P2|Participant Flow|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
232562|NCT01451541|P1|Participant Flow|Placebo|Placebo: placebo - one dose per nostril
232563|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
232564|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
232565|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
232566|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
232567|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
232568|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
232569|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
232570|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
232571|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
232572|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
232573|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
232574|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
232575|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
232576|NCT01451541|O1|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
232577|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
232578|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
232579|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
232580|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
232581|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
232582|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
232583|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
232584|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
232585|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
232586|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
232587|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
232588|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
232589|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
232590|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
232591|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
232592|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
232593|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
232594|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
232595|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
232596|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
232597|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
232598|NCT01451541|E3|Reported Event|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
232599|NCT01451541|E2|Reported Event|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
263093|NCT01350401|O2|Outcome|Subject 1 - Day 60|
232601|NCT01451463|B1|Baseline|Individuals on Stable Doses of Tetrabenazine|11 Individuals on stable doses of tetrabenazine were studied while off medication and then following resumption of medication.
232602|NCT01451463|P1|Participant Flow|Individuals on Stable Doses of Tetrabenazine|Individuals on stable doses of tetrabenazine were studied while off medication and then following resumption of medication.
232603|NCT01451463|O2|Outcome|Individuals Off Their Stable Dose of Tetrabenazine for > 18 hr|11 Individuals who have been on stable doses of tetrabenazine were studied after being off medication for > 18 hours.
232604|NCT01451463|O1|Outcome|Individuals Resuming Their Stable Doses of Tetrabenazine|11 Individuals on stable doses of tetrabenazine were studied two hours after resuming their medication after being off medication for > 18 hours.
232605|NCT01451463|O2|Outcome|Individuals Off Their Stable Dose of Tetrabenazine for > 18 hr|11 Individuals on stable doses of tetrabenazine were studied on the 5 times sit to stand test while off medication
232606|NCT01451463|O1|Outcome|Individuals 2 Hours After Resuming Tetrabenazine|11 Individuals on stable doses of tetrabenazine were studied on the 5 times sit to stand test following resumption of medication . > 18 hours after being off their medication.
232607|NCT01451463|O2|Outcome|Individuals Off Their Stable Dose of Tetrabenazine for > 18 hr|11 Individuals on stable doses of tetrabenazine were studied on the Tinetti Mobility Test after being off their stable dose of medication for > 18 hours
232608|NCT01451463|O1|Outcome|Individuals 2 Hours After Resuming Tetrabenazine|11 Individuals on stable doses of tetrabenazine were studied on the Tinetti Mobility Test following resumption of medication > 18 hours after being off their regular stable dose of medication.
232609|NCT01451463|E1|Reported Event|Individuals on Stable Doses of Tetrabenazine|Individuals on stable doses of tetrabenazine were studied while off medication and then following resumption of medication.
232610|NCT01451437|B10|Baseline|Total|Total of all reporting groups
232611|NCT01451437|B9|Baseline|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
232612|NCT01451437|B8|Baseline|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
232613|NCT01451437|B7|Baseline|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
232614|NCT01451437|B6|Baseline|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
232615|NCT01451437|B5|Baseline|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
232616|NCT01451437|B4|Baseline|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232617|NCT01451437|B3|Baseline|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232618|NCT01451437|B2|Baseline|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232619|NCT01451437|B1|Baseline|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232620|NCT01451437|P9|Participant Flow|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
232621|NCT01451437|P8|Participant Flow|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
232622|NCT01451437|P7|Participant Flow|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
232623|NCT01451437|P6|Participant Flow|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
232624|NCT01451437|P5|Participant Flow|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
232625|NCT01451437|P4|Participant Flow|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232626|NCT01451437|P3|Participant Flow|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232627|NCT01451437|P2|Participant Flow|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232628|NCT01451437|P1|Participant Flow|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232629|NCT01451437|O9|Outcome|Pt 2 Arm A: MK-8242 300 mg BID|Participants to receive MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg to be administered QD in the morning) in Part 2 Arm A.
232630|NCT01451437|O8|Outcome|Pt 2 Arm A: MK-8242 250 mg BID|Participants to receive MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg to be administered QD in the morning) in Part 2 Arm A.
232631|NCT01451437|O7|Outcome|Pt 2 Arm A: MK-8242 210 mg BID|Participants to receive MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg to be administered QD in the morning) in Part 2 Arm A.
232632|NCT01451437|O6|Outcome|Pt 2 Arm A: MK-8242 170 mg BID|Participants to receive MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg to be administered QD in the morning) in Part 2 Arm A.
232633|NCT01451437|O5|Outcome|Pt 2 Arm A: MK-8242 120 mg BID|Participants to receive MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg to be administered QD in the morning) in Part 2 Arm A.
232634|NCT01451437|O4|Outcome|Pt 2 Arm A: MK-8242 250 mg QD|Participants to receive MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 2 Arm A.
232635|NCT01451437|O3|Outcome|Pt 2 Arm A: MK-8242 120 mg QD|Participants to receive MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 2 Arm A.
232636|NCT01451437|O2|Outcome|Pt 2 Arm A: MK-8242 60 mg QD|Participants to receive MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 2 Arm A.
232637|NCT01451437|O1|Outcome|Pt 2 Arm A: MK-8242 30 mg QD|Participants to receive MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 2 Arm A.
232638|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
232639|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
232640|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
232641|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
232642|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
232643|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232644|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232645|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232646|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232647|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
232648|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
232649|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
232650|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
232651|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
232652|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232653|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232654|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232655|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232656|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
232657|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
232658|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
232659|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
232660|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
232661|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232662|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232663|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232664|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232665|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
232666|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
232667|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
232668|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
232669|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
232670|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232671|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232672|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232673|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232674|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
232675|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
232676|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
232677|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
232678|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
232679|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232680|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232681|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232682|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232683|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
232684|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
232685|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
232686|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
232687|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
232688|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232689|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232690|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232691|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232692|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
232693|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
232694|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
232695|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
232696|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
232697|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232698|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232699|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232700|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232701|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
232702|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
232703|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
232704|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
232705|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
232706|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232707|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232708|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232709|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232710|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
232711|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
232712|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
232713|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
232714|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
232715|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232716|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232717|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232718|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232719|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
232720|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
232721|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
232722|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
232723|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
232724|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232725|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232726|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232727|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232728|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
232729|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
232803|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
232804|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
232730|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
232731|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
232732|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
232733|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232734|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232735|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232736|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232737|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
232738|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
232739|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
232740|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
232741|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
232742|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232743|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232744|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232745|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232746|NCT01451437|E9|Reported Event|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
232747|NCT01451437|E8|Reported Event|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
232748|NCT01451437|E7|Reported Event|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
232749|NCT01451437|E6|Reported Event|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
232750|NCT01451437|E5|Reported Event|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
232751|NCT01451437|E4|Reported Event|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232752|NCT01451437|E3|Reported Event|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232753|NCT01451437|E2|Reported Event|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232754|NCT01451437|E1|Reported Event|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
232755|NCT01451424|B5|Baseline|Total|Total of all reporting groups
232756|NCT01451424|B4|Baseline|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks"
232757|NCT01451424|B3|Baseline|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 weeks Includes subjects from both arms 1 and 3 (PK group and non-PK groups)"
232758|NCT01451424|B2|Baseline|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
232759|NCT01451424|B1|Baseline|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
232760|NCT01451424|P4|Participant Flow|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks~All subjects completed the placebo run-in period and started active dosing."
232761|NCT01451424|P3|Participant Flow|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 or 16 weeks~The first 6 subjects dosed at 12 mg (arm 1, PK group) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks~The first 6 subjects (arm 1) had no placebo run-in period. Arm 3 subjects all completed the placebo run-in period and started active dosing."
232805|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
232806|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
232762|NCT01451424|P2|Participant Flow|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks~All subjects completed the placebo run-in period and started active dosing."
232763|NCT01451424|P1|Participant Flow|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks~All subjects completed the placebo run-in period and started active dosing."
232764|NCT01451424|O4|Outcome|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks"
232765|NCT01451424|O3|Outcome|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 or 16 weeks~The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks"
232766|NCT01451424|O2|Outcome|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
232767|NCT01451424|O1|Outcome|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
232768|NCT01451424|O4|Outcome|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks"
232769|NCT01451424|O3|Outcome|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 or 16 weeks~The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks"
232770|NCT01451424|O2|Outcome|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
232771|NCT01451424|O1|Outcome|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
232772|NCT01451424|O4|Outcome|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks"
232773|NCT01451424|O3|Outcome|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 or 16 weeks~The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks"
232774|NCT01451424|O2|Outcome|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
232775|NCT01451424|O1|Outcome|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
232776|NCT01451424|O4|Outcome|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks"
232777|NCT01451424|O3|Outcome|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 or 16 weeks~The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks"
232778|NCT01451424|O2|Outcome|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
232779|NCT01451424|O1|Outcome|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
232780|NCT01451424|O5|Outcome|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks"
232781|NCT01451424|O4|Outcome|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 or 16 weeks~The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks"
232782|NCT01451424|O3|Outcome|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
232783|NCT01451424|O2|Outcome|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
232784|NCT01451424|O1|Outcome|Proellex 12 mg PK Group|"Subjects receiving 12 mg Proellex administered vaginally, and completing a PK arm consisting of 1 x 24 hr PK of Proellex, 14 days of daily Proellex trough measurements, and 1 x 24 hr PK of Proellex after 14 days of daily dosing. 12 mg PK subjects will continue with the protocol as written after the first 2 week period.~Proellex: vaginal suppository, daily, for 12 weeks"
232785|NCT01451424|O4|Outcome|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks"
232786|NCT01451424|O3|Outcome|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 or 16 weeks~The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks"
232787|NCT01451424|O2|Outcome|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
232788|NCT01451424|O1|Outcome|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
232789|NCT01451424|E4|Reported Event|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 12 weeks"
232790|NCT01451424|E3|Reported Event|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
232791|NCT01451424|E2|Reported Event|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
232792|NCT01451424|E1|Reported Event|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
232793|NCT01451411|B3|Baseline|Total|Total of all reporting groups
232794|NCT01451411|B2|Baseline|Placebo|Placebo: Intravenous
232795|NCT01451411|B1|Baseline|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
232796|NCT01451411|P2|Participant Flow|Placebo|Placebo: Intravenous
232797|NCT01451411|P1|Participant Flow|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
232798|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
232799|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
232800|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
232801|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
232819|NCT01451398|B2|Baseline|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232820|NCT01451398|B1|Baseline|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232821|NCT01451398|P2|Participant Flow|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232822|NCT01451398|P1|Participant Flow|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232823|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232824|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232825|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232826|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232827|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232828|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232829|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232830|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232831|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232832|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232833|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232834|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232835|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232836|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232837|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232838|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232839|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232840|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232841|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232842|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232843|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232844|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232845|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232846|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232847|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232848|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232849|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232850|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
232851|NCT01451398|E2|Reported Event|Technosphere Powder|"technosphere powder (with no insulin) administered via the Gen2 inhaler added to 1 - 3 stable OADs~Technosphere Powder: Placebo Comparator"
232852|NCT01451398|E1|Reported Event|TI Inhalation Powder|"Technosphere® Insulin powder administered via the Gen2 inhaler added to 1 - 3 stable OADs~Technosphere® Insulin: Technosphere® Insulin Inhalation Powder"
232853|NCT01451203|B3|Baseline|Total|Total of all reporting groups
232854|NCT01451203|B2|Baseline|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
232855|NCT01451203|B1|Baseline|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
232856|NCT01451203|P2|Participant Flow|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
232857|NCT01451203|P1|Participant Flow|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
232858|NCT01451203|O2|Outcome|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
232859|NCT01451203|O1|Outcome|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
232860|NCT01451203|O2|Outcome|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
232861|NCT01451203|O1|Outcome|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
232862|NCT01451203|O2|Outcome|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
232863|NCT01451203|O1|Outcome|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
232864|NCT01451203|O2|Outcome|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
232865|NCT01451203|O1|Outcome|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
232866|NCT01451203|O2|Outcome|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
232867|NCT01451203|O1|Outcome|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
232868|NCT01451203|E2|Reported Event|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
232869|NCT01451203|E1|Reported Event|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
232870|NCT01450813|B5|Baseline|Total|Total of all reporting groups
232871|NCT01450813|B4|Baseline|Group 4|Rocuronium dose 0.6 mg/kg prior to laryngoscopy
232872|NCT01450813|B3|Baseline|Group 3|Rocuronium dose 0.4 mg/kg prior to laryngoscopy
232873|NCT01450813|B2|Baseline|Group 2|Rocuronium dose 0.2 mg/kg prior to laryngoscopy
232874|NCT01450813|B1|Baseline|Group 1|Rocuronium dose 0 mg/kg prior to laryngoscopy
232875|NCT01450813|P4|Participant Flow|Group 4|Rocuronium 0.6 mg/kg
232876|NCT01450813|P3|Participant Flow|Group 3|Rocuronium 0.4 mg/kg
232877|NCT01450813|P2|Participant Flow|Group 2|Rocuronium 0.2 mg/kg
232878|NCT01450813|P1|Participant Flow|Group 1|Saline 0.06 ml/kg
232879|NCT01450813|O2|Outcome|Remifentanil 8 ng/ml|The anesthesia provider will titrate propofol as appropriate throughout the procedure to maintain a BIS level between 45- 60.
232880|NCT01450813|O1|Outcome|Remifentanil 2ng/ml|The anesthesia provider will titrate propofol as appropriate throughout the procedure to maintain a BIS level between 45- 60.
232881|NCT01450813|O4|Outcome|Group 4|Rocuronium 0.6mg/kg
232882|NCT01450813|O3|Outcome|Group 3|Rocuronium 0.4mg/kg
232883|NCT01450813|O2|Outcome|Group 2|Rocuronium 0.2mg/kg
232884|NCT01450813|O1|Outcome|Group 1|Rocuronium 0mg/kg
232885|NCT01450813|E4|Reported Event|Group 4|Rocuronium dose 0.6 mg/kg
232886|NCT01450813|E3|Reported Event|Group 3|Rocuronium dose 0.4 mg/kg
232887|NCT01450813|E2|Reported Event|Group 2|Rocuronium dose 0.2 mg/kg
232888|NCT01450813|E1|Reported Event|Group 1|Rocuronium dose 0 mg/kg
232889|NCT01450800|B3|Baseline|Total|Total of all reporting groups
232890|NCT01450800|B2|Baseline|Placebo|Participants randomized to receive placebo instructed to take placebo 1 tablet by mouth daily starting on postoperative day 1 for up to 7 days during catheterization
263451|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
232891|NCT01450800|B1|Baseline|Nitrofurantoin|Participants randomized to receive antibiotics instructed to take nitrofurantoin 100mg by mouth daily starting on postoperative day 1 for up to 7 days during catheterization
232892|NCT01450800|P2|Participant Flow|Placebo|Randomized to placebo 1 tablet daily for each day of catheterization for up to 7 days
232893|NCT01450800|P1|Participant Flow|Nitrofurantoin|Randomized to nitrofurantoin 100mg daily for each day of catheterization for up to 7 days
232894|NCT01450800|O1|Outcome|Urine Cultures Performed|All participants in the final analysis were examined
232895|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
232896|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
232897|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
232898|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
232899|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
232900|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
232901|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
232902|NCT01450800|O2|Outcome|Placebo|Randomized to placebo 1 tab daily while using a catheter for up to 7 days
232903|NCT01450800|O1|Outcome|Nitrofurantoin|Randomized to nitrofurantoin 100mg daily while using a catheter for up to 7 days
232904|NCT01450800|E2|Reported Event|Placebo|Participants randomized to receive placebo 1 tablet by mouth daily each day of catheterization for up to one week after surgery
232905|NCT01450800|E1|Reported Event|Nitrofurantoin|Participants randomized to receive nitrofurantoin 100mg by mouth daily each day of catheterization for up to one week after surgery
232906|NCT01450787|B3|Baseline|Total|Total of all reporting groups
232907|NCT01450787|B2|Baseline|Non Diabetics|non diabetics over age 40
232908|NCT01450787|B1|Baseline|Diabetics|diabetics over age 40
232909|NCT01450787|P2|Participant Flow|Non Diabetics|non diabetics over age 40
232910|NCT01450787|P1|Participant Flow|Diabetics|diabetics over age 40
232911|NCT01450787|O2|Outcome|Non Diabetics|non diabetics over age 40
232912|NCT01450787|O1|Outcome|Diabetics|diabetics over age 40
232913|NCT01450787|O2|Outcome|Non Diabetics|non diabetics over age 40
232914|NCT01450787|O1|Outcome|Diabetics|diabetics over age 40
232915|NCT01450787|O2|Outcome|Non Diabetics|non diabetics over age 40
232916|NCT01450787|O1|Outcome|Diabetics|diabetics over age 40
232917|NCT01450787|O2|Outcome|Non Diabetics|non diabetics over age 40
232918|NCT01450787|O1|Outcome|Diabetics|diabetics over age 40
232919|NCT01450787|O2|Outcome|Non Diabetics|non diabetics over age 40
232920|NCT01450787|O1|Outcome|Diabetics|diabetics over age 40
232921|NCT01450787|O2|Outcome|Non Diabetics|non diabetics over age 40
232922|NCT01450787|O1|Outcome|Diabetics|diabetics over age 40
232923|NCT01450787|E2|Reported Event|Non Diabetics|non diabetics over age 40
232924|NCT01450787|E1|Reported Event|Diabetics|diabetics over age 40
232925|NCT01450761|B3|Baseline|Total|Total of all reporting groups
232926|NCT01450761|B2|Baseline|Placebo and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
232927|NCT01450761|B1|Baseline|Ipilimumab and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
232928|NCT01450761|P2|Participant Flow|Placebo and Platinum/Etoposide|During the lead-in chemotherapy (induction) phase, participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles, with placebo every 3 weeks for cycles 3-6. During the treatment with blinded study therapy phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
232929|NCT01450761|P1|Participant Flow|Ipilimumab and Platinum/Etoposide|During the lead-in chemotherapy (induction) phase, participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles, with ipilimumab (10 mg/kg IV) every 3 weeks for cycles 3-6. During the treatment with blinded study therapy phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
232930|NCT01450761|O2|Outcome|Placebo and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
232931|NCT01450761|O1|Outcome|Ipilimumab and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
232932|NCT01450761|O2|Outcome|Placebo and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
233285|NCT01449734|P1|Participant Flow|Family Satisfaction|family satisfaction in the intensive care unit (ICU) and areas for improvement
232933|NCT01450761|O1|Outcome|Ipilimumab and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
232934|NCT01450761|O2|Outcome|Placebo and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
232935|NCT01450761|O1|Outcome|Ipilimumab and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
232936|NCT01450761|E2|Reported Event|PLACEBO + PLATINUM/ETOPOSIDE|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
232937|NCT01450761|E1|Reported Event|10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
232938|NCT01450696|B3|Baseline|Total|Total of all reporting groups
232939|NCT01450696|B2|Baseline|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
232940|NCT01450696|B1|Baseline|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
232941|NCT01450696|P2|Participant Flow|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
232942|NCT01450696|P1|Participant Flow|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 milligrams per kilogram (mg/kg) on Day 1 of Cycle 1 followed by 6 mg/kg every three weeks (q3w) as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 milligrams per meter-squared (mg/m^2) intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
232943|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
232944|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
232945|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
232946|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
232947|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
232997|NCT01450306|P1|Participant Flow|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
234517|NCT01446289|O4|Outcome|Infants Placebo|Infants born from mothers who received one injection of saline solution.
232948|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
232949|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
232950|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
232951|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
232952|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
232953|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
232954|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
232955|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
232956|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
232957|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
232958|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
232959|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
232960|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
232961|NCT01450696|E2|Reported Event|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
232998|NCT01450306|O2|Outcome|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
232962|NCT01450696|E1|Reported Event|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
232963|NCT01450683|B1|Baseline|Itraconazole|"Itraconazole: 600 mg/day oral (PO)~IUPAC name: (2R,4S)-rel-1-(Butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one"
232964|NCT01450683|P1|Participant Flow|Itraconazole|"Itraconazole: 600 mg/day oral (PO)~IUPAC name: (2R,4S)-rel-1-(Butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one"
232965|NCT01450683|O1|Outcome|Itraconazole|"Itraconazole: 600 mg/day oral (PO)~IUPAC name: (2R,4S)-rel-1-(Butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one"
232966|NCT01450683|E1|Reported Event|Itraconazole|"Itraconazole: 600 mg/day oral (PO)~IUPAC name: (2R,4S)-rel-1-(Butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one"
232967|NCT01450631|B3|Baseline|Total|Total of all reporting groups
232968|NCT01450631|B2|Baseline|Prevena™ (PIMS)|"PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.~Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister."
232969|NCT01450631|B1|Baseline|Standard Dressing|"Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.~Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy."
232970|NCT01450631|P2|Participant Flow|Prevena™ (PIMS)|"PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.~Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister."
232971|NCT01450631|P1|Participant Flow|Standard Dressing|"Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.~Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy."
232972|NCT01450631|O2|Outcome|Prevena™ (PIMS)|"PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.~Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister."
232973|NCT01450631|O1|Outcome|Standard Dressing|"Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.~Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy."
232974|NCT01450631|O2|Outcome|Prevena™ (PIMS)|"PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.~Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister."
232975|NCT01450631|O1|Outcome|Standard Dressing|"Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.~Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy."
232976|NCT01450631|E2|Reported Event|Prevena™ (PIMS)|"PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.~Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister."
232977|NCT01450631|E1|Reported Event|Standard Dressing|"Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.~Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy."
232978|NCT01450397|B1|Baseline|XIAFLEX|Patient who have received XIAFLEX
232979|NCT01450397|P1|Participant Flow|XIAFLEX|0.58 mg of Xiaflex injected into a palpable Dupuytren's cord
232980|NCT01450397|O1|Outcome|XIAFLEX|Subjects receiving one Xiaflex injection
232981|NCT01450397|E1|Reported Event|XIAFLEX|Patient who received XIAFLEX
232982|NCT01450319|B1|Baseline|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
232983|NCT01450319|P1|Participant Flow|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
232984|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
232985|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
232986|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
232987|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
232988|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
232989|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
232990|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
232991|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
232992|NCT01450319|E1|Reported Event|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
232993|NCT01450306|B3|Baseline|Total|Total of all reporting groups
232994|NCT01450306|B2|Baseline|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
232995|NCT01450306|B1|Baseline|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
232996|NCT01450306|P2|Participant Flow|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
234518|NCT01446289|O3|Outcome|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
232999|NCT01450306|O1|Outcome|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
233000|NCT01450306|O2|Outcome|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
233001|NCT01450306|O1|Outcome|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
233002|NCT01450306|O2|Outcome|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
233003|NCT01450306|O1|Outcome|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
233004|NCT01450306|E2|Reported Event|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
233005|NCT01450306|E1|Reported Event|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
233006|NCT01450189|B4|Baseline|Total|Total of all reporting groups
233007|NCT01450189|B3|Baseline|Behavioral Intervention Plus Antiretrovirals (BIA)|"The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.~ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks."
233008|NCT01450189|B2|Baseline|Behavioral Intervention Arm|"The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233009|NCT01450189|B1|Baseline|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection."
233010|NCT01450189|P3|Participant Flow|Behavioral Intervention Plus Antiretrovirals (BIA)|"The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.~ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks."
233011|NCT01450189|P2|Participant Flow|Behavioral Intervention Arm|"The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233012|NCT01450189|P1|Participant Flow|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection."
233013|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
233086|NCT01450189|O2|Outcome|Behavioral Intervention Arm|"The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233014|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233015|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
233016|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
233017|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233018|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
233019|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
233020|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233021|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
233022|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
233110|NCT01450007|O1|Outcome|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
233111|NCT01450007|O3|Outcome|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
233023|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233024|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
233025|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
233026|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233027|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
233028|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
233029|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233030|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
233031|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
233112|NCT01450007|O2|Outcome|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
234519|NCT01446289|O2|Outcome|Mothers Placebo|Pregnant women who received one injection of saline solution.
233032|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233033|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
233034|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
233035|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233036|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
233037|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
233038|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233039|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
233040|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
233113|NCT01450007|O1|Outcome|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
233114|NCT01450007|O3|Outcome|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
233041|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233042|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
233043|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
233044|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233045|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
233046|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
233047|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233048|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
233049|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
233115|NCT01450007|O2|Outcome|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
234520|NCT01446289|O1|Outcome|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
233050|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233051|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
233052|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
233053|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233054|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
233055|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
233056|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233057|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
233058|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
233116|NCT01450007|O1|Outcome|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
233117|NCT01450007|E3|Reported Event|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
233059|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233060|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
233061|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
233062|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233063|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
233064|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
233065|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233066|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
233067|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
233118|NCT01450007|E2|Reported Event|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
234521|NCT01446289|E4|Reported Event|Infants Placebo|Infants born from mothers who received one injection of saline solution.
233068|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233069|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
233070|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
233071|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233072|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
233073|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
233074|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233075|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
233076|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
233119|NCT01450007|E1|Reported Event|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
233120|NCT01449955|B3|Baseline|Total|Total of all reporting groups
233121|NCT01449955|B2|Baseline|Placebo|15mg Placebo administered once in pill form
233077|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233078|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
233079|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
233080|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233081|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
233082|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
233083|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233084|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
233085|NCT01450189|O3|Outcome|Behavioral Intervention Plus Antiretrovirals (BIA)|"The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.~ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks."
233122|NCT01449955|B1|Baseline|Rapamycin|15mg Rapamycin administered once in pill form
233123|NCT01449955|P2|Participant Flow|Placebo|15mg Placebo administered once in pill form
233124|NCT01449955|P1|Participant Flow|Rapamycin (e.g., Sirolimus)|15mg Rapamycin administered once in pill form
233125|NCT01449955|O2|Outcome|Placebo|15 mg Placebo administered once in pill form
233126|NCT01449955|O1|Outcome|Rapamycin (e.g., Sirolimus)|15mg Rapamycin administered once in pill form
233087|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection."
233088|NCT01450189|O1|Outcome|Combined Behavioral Intervention Arms|Both the behavioral intervention and behavioral intervention plus antiretroviral arms are combined in this outcome
233089|NCT01450189|O3|Outcome|Behavioral Intervention Plus Antiretrovirals (BIA)|"The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.~ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks."
233090|NCT01450189|O2|Outcome|Behavioral Intervention Arm|"The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233091|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection."
233092|NCT01450189|O1|Outcome|Overall|
233093|NCT01450189|O1|Outcome|Overall|
233094|NCT01450189|O1|Outcome|Overall|All arms combined
233095|NCT01450189|E3|Reported Event|Behavioral Intervention Plus Antiretrovirals (BIA)|"The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.~ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks."
233096|NCT01450189|E2|Reported Event|Behavioral Intervention Arm|"The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
233097|NCT01450189|E1|Reported Event|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection."
233098|NCT01450007|B4|Baseline|Total|Total of all reporting groups
233099|NCT01450007|B3|Baseline|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
233100|NCT01450007|B2|Baseline|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
233101|NCT01450007|B1|Baseline|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
233102|NCT01450007|P3|Participant Flow|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
233103|NCT01450007|P2|Participant Flow|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
233104|NCT01450007|P1|Participant Flow|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
233105|NCT01450007|O3|Outcome|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
233106|NCT01450007|O2|Outcome|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
233107|NCT01450007|O1|Outcome|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
233108|NCT01450007|O3|Outcome|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
233109|NCT01450007|O2|Outcome|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
233130|NCT01449929|B2|Baseline|DRV 800 mg + RTV 100 mg QD|Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
233131|NCT01449929|B1|Baseline|DTG 50 mg QD|Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
233132|NCT01449929|P3|Participant Flow|Extension DTG 50 mg|DTG participants who successfully completed 96 Weeks of randomized phase continued to receive DTG 50 mg QD during Extension phase
233133|NCT01449929|P2|Participant Flow|DRV 800 mg + RTV 100 mg QD|Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
233134|NCT01449929|P1|Participant Flow|DTG 50 mg QD|Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
233135|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg QD|Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
233136|NCT01449929|O1|Outcome|DTG 50 mg QD|Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
233137|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg QD|Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
233138|NCT01449929|O1|Outcome|DTG 50 mg QD|Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
233139|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg QD|Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
233140|NCT01449929|O1|Outcome|DTG 50 mg QD|Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
233141|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg QD|Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
233142|NCT01449929|O1|Outcome|DTG 50 mg QD|Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
233143|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg QD|Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
233144|NCT01449929|O1|Outcome|DTG 50 mg QD|Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
233145|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg QD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
233146|NCT01449929|O1|Outcome|DTG 50 mg QD|Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
233147|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
233148|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg OD during an Extension Phase of the study.
233149|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg QD|Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
233150|NCT01449929|O1|Outcome|DTG 50 mg QD|Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
233151|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg QD|Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
233152|NCT01449929|O1|Outcome|DTG 50 mg QD|Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
233153|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg QD|Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
233154|NCT01449929|O1|Outcome|DTG 50 mg QD|Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
233155|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg QD|Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
233156|NCT01449929|O1|Outcome|DTG 50 mg QD|Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
233157|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg QD|Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
233158|NCT01449929|O1|Outcome|DTG 50 mg QD|Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
233286|NCT01449734|O1|Outcome|Family Satisfaction|All 215 surveyed relatives are contained in this group, since the study was observational without intervention.
233159|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
233160|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg OD during an Extension Phase of the study.
233161|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg QD|Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
233162|NCT01449929|O1|Outcome|DTG 50 mg QD|Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
233163|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg QD|Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
233164|NCT01449929|O1|Outcome|DTG 50 mg QD|Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
233165|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg QD|Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
233166|NCT01449929|O1|Outcome|DTG 50 mg QD|Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
233167|NCT01449929|E3|Reported Event|Extension DTG 50 mg|DTG participants who successfully completed 96 Weeks of randomized phase continued to receive DTG 50 mg QD during Extension phase
233168|NCT01449929|E2|Reported Event|DRV 800 mg + RTV 100 mg QD|Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
233169|NCT01449929|E1|Reported Event|DTG 50mg QD|Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
233170|NCT01449812|B4|Baseline|Total|Total of all reporting groups
233171|NCT01449812|B3|Baseline|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233172|NCT01449812|B2|Baseline|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233173|NCT01449812|B1|Baseline|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233174|NCT01449812|P3|Participant Flow|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233175|NCT01449812|P2|Participant Flow|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233176|NCT01449812|P1|Participant Flow|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233177|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233178|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233179|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233287|NCT01449734|E1|Reported Event|Family Satisfaction|family satisfaction in the intensive care unit (ICU) and areas for improvement
233288|NCT01449721|B3|Baseline|Total|Total of all reporting groups
235135|NCT01443923|B1|Baseline|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
233180|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233181|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233182|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233183|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233184|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233185|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233186|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233187|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233188|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233189|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233190|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233191|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233192|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233193|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233194|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233289|NCT01449721|B2|Baseline|Interventional Arm|"Protocolized empiric resuscitation delivering weight-based intravenous fluid resuscitation targeting lactate normalization~Intravenous fluid: 0.9% Sodium chloride intravenous fluid"
233290|NCT01449721|B1|Baseline|Control|Standard medical care by the primary treatment team.
233195|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233196|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233197|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233198|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233199|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233200|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233201|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233202|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233203|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233204|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233205|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233206|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233207|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233208|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233209|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233291|NCT01449721|P2|Participant Flow|Interventional Arm|"Protocolized empiric resuscitation delivering weight-based intravenous fluid resuscitation targeting lactate normalization~Intravenous fluid: 0.9% Sodium chloride intravenous fluid"
233292|NCT01449721|P1|Participant Flow|Control|Standard medical care by the primary treatment team.
233210|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233211|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233212|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233213|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233214|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233215|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233216|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233217|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233218|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233219|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233220|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233221|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233222|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233223|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233224|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233293|NCT01449721|O2|Outcome|Interventional Arm|"Protocolized empiric resuscitation delivering weight-based intravenous fluid resuscitation targeting lactate normalization~Intravenous fluid: 0.9% Sodium chloride intravenous fluid"
233294|NCT01449721|O1|Outcome|Control|Standard medical care by the primary treatment team.
233225|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233226|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233227|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233228|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233229|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233230|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233231|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233232|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233233|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233234|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233235|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233236|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233237|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233238|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233239|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233295|NCT01449721|O2|Outcome|Interventional Arm|"Protocolized empiric resuscitation delivering weight-based intravenous fluid resuscitation targeting lactate normalization~Intravenous fluid: 0.9% Sodium chloride intravenous fluid"
233296|NCT01449721|O1|Outcome|Control|Standard medical care by the primary treatment team.
233240|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233241|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233242|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233243|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233244|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233245|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233246|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233247|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233248|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233249|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233250|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233251|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233252|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233253|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233254|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233297|NCT01449721|O2|Outcome|Interventional Arm|"Protocolized empiric resuscitation delivering weight-based intravenous fluid resuscitation targeting lactate normalization~Intravenous fluid: 0.9% Sodium chloride intravenous fluid"
233298|NCT01449721|O1|Outcome|Control|Standard medical care by the primary treatment team.
233255|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233256|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233257|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233258|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233259|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233260|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233261|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233262|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233263|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233264|NCT01449812|E3|Reported Event|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233265|NCT01449812|E2|Reported Event|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233266|NCT01449812|E1|Reported Event|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
233267|NCT01449747|B3|Baseline|Total|Total of all reporting groups
233268|NCT01449747|B2|Baseline|Responder|Sitagliptin response patients
233269|NCT01449747|B1|Baseline|Non-responder|Sitagliptin non-response patients
233270|NCT01449747|P2|Participant Flow|Responder|Sitagliptin response patients
233271|NCT01449747|P1|Participant Flow|Non-responder|Sitagliptin non-response patients
233272|NCT01449747|O2|Outcome|Responder|Sitagliptin response patients
233273|NCT01449747|O1|Outcome|Non-responder|Sitagliptin non-response patients
233274|NCT01449747|O2|Outcome|Responder|Sitagliptin response patients
233275|NCT01449747|O1|Outcome|Non-responder|Sitagliptin non-response patients
233276|NCT01449747|O2|Outcome|Responder|Sitagliptin response patients
233277|NCT01449747|O1|Outcome|Non-responder|Sitagliptin non-response patients
233278|NCT01449747|O2|Outcome|Responder|Sitagliptin response patients
233279|NCT01449747|O1|Outcome|Non-responder|Sitagliptin non-response patients
233280|NCT01449747|O2|Outcome|Responder|Sitagliptin response patients
233281|NCT01449747|O1|Outcome|Non-responder|Sitagliptin non-response patients
233282|NCT01449747|E2|Reported Event|Responder|Sitagliptin response patients
233283|NCT01449747|E1|Reported Event|Non-responder|Sitagliptin non-response patients
233284|NCT01449734|B1|Baseline|Family Satisfaction|family satisfaction in the intensive care unit (ICU) and areas for improvement
233299|NCT01449721|E2|Reported Event|Interventional Arm|"Protocolized empiric resuscitation delivering weight-based intravenous fluid resuscitation targeting lactate normalization~Intravenous fluid: 0.9% Sodium chloride intravenous fluid"
233300|NCT01449721|E1|Reported Event|Control|Standard medical care by the primary treatment team.
233301|NCT01449708|B3|Baseline|Total|Total of all reporting groups
233302|NCT01449708|B2|Baseline|TIVA|"patients in both groups receive antiemetic prophylaxis~patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively~postop management in both groups is similar in both groups"
233303|NCT01449708|B1|Baseline|Classic/Balanced Anesthesia|"Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice.~patients in both groups receive antiemetic prophylaxis~postop management in both groups is similar in both groups"
233304|NCT01449708|P2|Participant Flow|TIVA|"TIVA NoNarc (Study): - patients in both groups receive antiemetic prophylaxis~- patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively"
233305|NCT01449708|P1|Participant Flow|Classic/Balanced Anesthesia|"Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice. (Control)~postop management in both groups is similar in both groups"
233306|NCT01449708|O1|Outcome|All Study Participants|measure included all119 patients depending on surgical procedure
233307|NCT01449708|O2|Outcome|TIVA|"TIVA NoNarc (Study): - patients in both groups receive antiemetic prophylaxis~- patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively"
233308|NCT01449708|O1|Outcome|Classic/Balanced Anesthesia|"Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice. (Control)~postop management in both groups is similar in both groups"
233309|NCT01449708|O2|Outcome|TIVA|patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively
233310|NCT01449708|O1|Outcome|Classic / Balanced Anesthesia|Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. (Control)
233311|NCT01449708|E2|Reported Event|TIVA|patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively
233312|NCT01449708|E1|Reported Event|Classic/Balanced Anesthesia|Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. (Control)
233313|NCT01449682|B3|Baseline|Total|Total of all reporting groups
233314|NCT01449682|B2|Baseline|Ozurdex q16 Weeks|"Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and every 16 weeks~Other Name: Ozurdex PRN"
233315|NCT01449682|B1|Baseline|Ozurdex PRN|"Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and PRN every 16 weeks~Other Name: Ozurdex PRN"
233316|NCT01449682|P2|Participant Flow|Active Comparator: Ozurdex q16 Weeks|"Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and every 16 weeks~Other Name: Ozurdex q16 weeks"
233317|NCT01449682|P1|Participant Flow|Active Comparator: Ozurdex PRN|"Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and PRN every 16 weeks~Other Name: Ozurdex PRN"
233318|NCT01449682|O2|Outcome|Ozurdex Q16 Weeks|"0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks~Ozurdex: 0.7 mg intravitreal DEX implant on first visit then every 16 weeks"
233319|NCT01449682|O1|Outcome|Ozurdex PRN|"0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT~Ozurdex: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies"
233320|NCT01449682|O2|Outcome|Ozurdex Q16 Weeks|"0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks~Ozurdex: 0.7 mg intravitreal DEX implant on first visit then every 16 weeks"
233321|NCT01449682|O1|Outcome|Ozurdex PRN|"0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT~Ozurdex: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies"
233322|NCT01449682|O2|Outcome|Ozurdex Q16 Weeks|"0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks~Ozurdex: 0.7 mg intravitreal DEX implant on first visit then every 16 weeks"
233323|NCT01449682|O1|Outcome|Ozurdex PRN|"0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT~Ozurdex: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies"
233324|NCT01449682|O2|Outcome|Ozurdex Q16 Weeks|"0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks~Ozurdex: 0.7 mg intravitreal DEX implant on first visit then every 16 weeks"
233325|NCT01449682|O1|Outcome|Ozurdex PRN|"0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT~Ozurdex: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies"
233326|NCT01449682|E2|Reported Event|Ozurdex Q16 Weeks|"0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks~Ozurdex: 0.7 mg intravitreal DEX implant on first visit then every 16 weeks"
233327|NCT01449682|E1|Reported Event|Ozurdex PRN|"0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT~Ozurdex: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies"
233328|NCT01449539|B1|Baseline|Hyperbaric Oxygen Therapy|Treatment Monday through Friday in a monoplace hyperbaric chamber 100% oxygen at 2.0 atmospheres for 90 minutes at pressure. Treatment lasts about 2 hours as time is allowed for gradual pressurization and depressurization. Treated for two weeks a total of 10 HBOT treatments.
233329|NCT01449539|P1|Participant Flow|Hyperbaric Oxygen Therapy|Daily HBOT treatments (100% oxygen at 2.0 atmospheres (14.7) PSI for 90 minutes) for 10 days (Monday-Friday for two weeks) in conjunction with standard growth factor treatment regimens
233330|NCT01449539|O1|Outcome|Hyperbaric Oxygen Therapy|Treatment Monday through Friday in a monoplace hyperbaric chamber 100% oxygen at 2.0 atmospheres (the equivalent of being under 33 feet of sea water) for 90 minutes. Treatment lasts 2 hours as time is allowed for gradual pressurization and depressurization. Each participant will be treated for two weeks for a total of 10 HBOT treatments.
263452|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
233331|NCT01449539|E1|Reported Event|Hyperbaric Oxygen Therapy|Daily HBOT treatments (100% oxygen at 2.0 atmospheres (14.7) PSI for 90 minutes) for 10 days (Monday-Friday for two weeks) in conjunction with standard growth factor treatment regimens
233332|NCT01449526|B3|Baseline|Total|Total of all reporting groups
233333|NCT01449526|B2|Baseline|B&L PureVision Contact Lens|"The Bausch + Lomb PureVision silicone hydrogel contact lens~B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
233334|NCT01449526|B1|Baseline|B&L Investigational Contact Lens|"The Bausch + Lomb investigational silicone hydrogel contact lens~B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
233335|NCT01449526|P2|Participant Flow|B&L PureVision Contact Lens|"The Bausch + Lomb PureVision silicone hydrogel contact lens~B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
233336|NCT01449526|P1|Participant Flow|B&L Investigational Contact Lens|"The Bausch + Lomb investigational silicone hydrogel contact lens~B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
233337|NCT01449526|O2|Outcome|B&L PureVision Contact Lens|"The Bausch + Lomb PureVision silicone hydrogel contact lens~B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
233338|NCT01449526|O1|Outcome|B&L Investigational Contact Lens|"The Bausch + Lomb investigational silicone hydrogel contact lens~B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
233339|NCT01449526|O2|Outcome|B&L PureVision Contact Lens|"The Bausch + Lomb PureVision silicone hydrogel contact lens~B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
233340|NCT01449526|O1|Outcome|B&L Investigational Contact Lens|"The Bausch + Lomb investigational silicone hydrogel contact lens~B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
233341|NCT01449526|E2|Reported Event|B&L PureVision Contact Lens|"The Bausch + Lomb PureVision silicone hydrogel contact lens~B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
233342|NCT01449526|E1|Reported Event|B&L Investigational Contact Lens|"The Bausch + Lomb investigational silicone hydrogel contact lens~B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
233343|NCT01449513|B3|Baseline|Total|Total of all reporting groups
233344|NCT01449513|B2|Baseline|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233345|NCT01449513|B1|Baseline|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233346|NCT01449513|P2|Participant Flow|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233347|NCT01449513|P1|Participant Flow|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233348|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233349|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233350|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233351|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233352|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233353|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233354|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233355|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233356|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233357|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233358|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233359|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233360|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233361|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233362|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233363|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233364|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233365|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233366|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233367|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233368|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233369|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233370|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233371|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233372|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233373|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233374|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233375|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233376|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233377|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233378|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233379|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233380|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233381|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233382|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233383|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233384|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233385|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233386|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233387|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233388|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233389|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233390|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233391|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233392|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233393|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233394|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233395|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233396|NCT01449513|E2|Reported Event|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
233397|NCT01449513|E1|Reported Event|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
233398|NCT01449461|B7|Baseline|Total|Total of all reporting groups
233399|NCT01449461|B6|Baseline|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, once daily (QD) or 120 mg, twice daily (BID) or 300 mg once daily, tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
233400|NCT01449461|B5|Baseline|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, twice daily (BID), tablets, orally in each cycle of 28 days (approximately, up to 44.4 months).
233401|NCT01449461|B4|Baseline|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days.
233402|NCT01449461|B3|Baseline|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
233403|NCT01449461|B2|Baseline|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233404|NCT01449461|B1|Baseline|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233405|NCT01449461|P6|Participant Flow|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, once daily (QD) or 120 mg, twice daily (BID) or 300 mg once daily, tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
233406|NCT01449461|P5|Participant Flow|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, twice daily (BID), tablets, orally in each cycle of 28 days (approximately, up to 44.4 months).
233407|NCT01449461|P4|Participant Flow|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days.
233408|NCT01449461|P3|Participant Flow|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
233409|NCT01449461|P2|Participant Flow|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233410|NCT01449461|P1|Participant Flow|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233411|NCT01449461|O6|Outcome|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, once daily (QD) or 120 mg, twice daily (BID) or 300 mg once daily, tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
233412|NCT01449461|O5|Outcome|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, twice daily (BID), tablets, orally in each cycle of 28 days (approximately, up to 44.4 months).
233413|NCT01449461|O4|Outcome|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days.
233414|NCT01449461|O3|Outcome|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
233415|NCT01449461|O2|Outcome|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233416|NCT01449461|O1|Outcome|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233417|NCT01449461|O6|Outcome|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, once daily (QD) or 120 mg, twice daily (BID) or 300 mg once daily, tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
233418|NCT01449461|O5|Outcome|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, twice daily (BID), tablets, orally in each cycle of 28 days (approximately, up to 44.4 months).
233419|NCT01449461|O4|Outcome|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days.
233420|NCT01449461|O3|Outcome|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
233421|NCT01449461|O2|Outcome|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233422|NCT01449461|O1|Outcome|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233423|NCT01449461|O6|Outcome|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, once daily (QD) or 120 mg, twice daily (BID) or 300 mg once daily, tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
233424|NCT01449461|O5|Outcome|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, twice daily (BID), tablets, orally in each cycle of 28 days (approximately, up to 44.4 months).
233425|NCT01449461|O4|Outcome|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days.
233426|NCT01449461|O3|Outcome|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
233427|NCT01449461|O2|Outcome|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233428|NCT01449461|O1|Outcome|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233429|NCT01449461|O6|Outcome|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, once daily (QD) or 120 mg, twice daily (BID) or 300 mg once daily, tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
233430|NCT01449461|O5|Outcome|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, twice daily (BID), tablets, orally in each cycle of 28 days (approximately, up to 44.4 months).
233431|NCT01449461|O4|Outcome|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days.
233432|NCT01449461|O3|Outcome|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
233433|NCT01449461|O2|Outcome|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233434|NCT01449461|O1|Outcome|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233435|NCT01449461|O6|Outcome|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, once daily (QD) or 120 mg, twice daily (BID) or 300 mg once daily, tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
233436|NCT01449461|O5|Outcome|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, twice daily (BID), tablets, orally in each cycle of 28 days (approximately, up to 44.4 months).
233437|NCT01449461|O4|Outcome|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days.
233438|NCT01449461|O3|Outcome|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
233439|NCT01449461|O2|Outcome|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233440|NCT01449461|O1|Outcome|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233441|NCT01449461|O6|Outcome|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, once daily (QD) or 120 mg, twice daily (BID) or 300 mg once daily, tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
233442|NCT01449461|O5|Outcome|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, twice daily (BID), tablets, orally in each cycle of 28 days (approximately, up to 44.4 months).
233443|NCT01449461|O4|Outcome|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days.
233444|NCT01449461|O3|Outcome|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
233445|NCT01449461|O2|Outcome|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233446|NCT01449461|O1|Outcome|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233447|NCT01449461|O6|Outcome|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, once daily (QD) or 120 mg, twice daily (BID) or 300 mg once daily, tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
233448|NCT01449461|O5|Outcome|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, twice daily (BID), tablets, orally in each cycle of 28 days (approximately, up to 44.4 months).
233449|NCT01449461|O4|Outcome|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days.
233450|NCT01449461|O3|Outcome|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
233451|NCT01449461|O2|Outcome|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233452|NCT01449461|O1|Outcome|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233453|NCT01449461|O6|Outcome|Brigatinib 240 mg|Brigatinib 240 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
233454|NCT01449461|O5|Outcome|Brigatinib 180 mg|Brigatinib 180 mg, tablets, orally once daily in each cycle of 28 days (approximately, up to 44.4 months).
233455|NCT01449461|O4|Outcome|Brigatinib 120 mg|Brigatinib 120 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
233456|NCT01449461|O3|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily or twice daily in each cycle of 28 days (approximately, up to 44.4 months).
233457|NCT01449461|O2|Outcome|Brigatinib 60 mg|Brigatinib 60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233458|NCT01449461|O1|Outcome|Brigatinib 30 mg|Brigatinib 30 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233459|NCT01449461|O7|Outcome|Brigatinib 300 mg|Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
233460|NCT01449461|O6|Outcome|Brigatinib 240 mg|Brigatinib 240 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
233461|NCT01449461|O5|Outcome|Brigatinib 180 mg|Brigatinib 180 mg, tablets, orally once daily in each cycle of 28 days (approximately, up to 44.4 months).
233462|NCT01449461|O4|Outcome|Brigatinib 120 mg|Brigatinib 120 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
233463|NCT01449461|O3|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily or twice daily in each cycle of 28 days (approximately, up to 44.4 months).
233464|NCT01449461|O2|Outcome|Brigatinib 60 mg|Brigatinib 60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233465|NCT01449461|O1|Outcome|Brigatinib 30 mg|Brigatinib 30 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233466|NCT01449461|O7|Outcome|Brigatinib 300 mg|Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
233467|NCT01449461|O6|Outcome|Brigatinib 240 mg|Brigatinib 240 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
233468|NCT01449461|O5|Outcome|Brigatinib 180 mg|Brigatinib 180 mg, tablets, orally once daily in each cycle of 28 days (approximately, up to 44.4 months).
233469|NCT01449461|O4|Outcome|Brigatinib 120 mg|Brigatinib 120 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
233470|NCT01449461|O3|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily or twice daily in each cycle of 28 days (approximately, up to 44.4 months).
233471|NCT01449461|O2|Outcome|Brigatinib 60 mg|Brigatinib 60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233472|NCT01449461|O1|Outcome|Brigatinib 30 mg|Brigatinib 30 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233473|NCT01449461|O7|Outcome|Brigatinib 300 mg|Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
233474|NCT01449461|O6|Outcome|Brigatinib 240 mg|Brigatinib 240 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
233475|NCT01449461|O5|Outcome|Brigatinib 180 mg|Brigatinib 180 mg, tablets, orally once daily in each cycle of 28 days (approximately, up to 44.4 months).
233476|NCT01449461|O4|Outcome|Brigatinib 120 mg|Brigatinib 120 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
233477|NCT01449461|O3|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily or twice daily in each cycle of 28 days (approximately, up to 44.4 months).
233478|NCT01449461|O2|Outcome|Brigatinib 60 mg|Brigatinib 60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233479|NCT01449461|O1|Outcome|Brigatinib 30 mg|Brigatinib 30 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233480|NCT01449461|O7|Outcome|Brigatinib 300 mg|Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
233481|NCT01449461|O6|Outcome|Brigatinib 240 mg|Brigatinib 240 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
233482|NCT01449461|O5|Outcome|Brigatinib 180 mg|Brigatinib 180 mg, tablets, orally once daily in each cycle of 28 days (approximately, up to 44.4 months).
233483|NCT01449461|O4|Outcome|Brigatinib 120 mg|Brigatinib 120 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
233484|NCT01449461|O3|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily or twice daily in each cycle of 28 days (approximately, up to 44.4 months).
233485|NCT01449461|O2|Outcome|Brigatinib 60 mg|Brigatinib 60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233486|NCT01449461|O1|Outcome|Brigatinib 30 mg|Brigatinib 30 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
238520|NCT01434186|B2|Baseline|Saxagliptin|saxagliptin 2.5 or 5 mg according to body weight
233487|NCT01449461|O7|Outcome|Brigatinib 300 mg|Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
233488|NCT01449461|O6|Outcome|Brigatinib 240 mg|Brigatinib 240 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
233489|NCT01449461|O5|Outcome|Brigatinib 180 mg|Brigatinib 180 mg, tablets, orally once daily in each cycle of 28 days (approximately, up to 44.4 months).
233490|NCT01449461|O4|Outcome|Brigatinib 120 mg|Brigatinib 120 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
233491|NCT01449461|O3|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily or twice daily in each cycle of 28 days (approximately, up to 44.4 months).
233492|NCT01449461|O2|Outcome|Brigatinib 60 mg|Brigatinib 60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233493|NCT01449461|O1|Outcome|Brigatinib 30 mg|Brigatinib 30 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233494|NCT01449461|O7|Outcome|Brigatinib 300 mg|Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
233495|NCT01449461|O6|Outcome|Brigatinib 240 mg|Brigatinib 240 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
233496|NCT01449461|O5|Outcome|Brigatinib 180 mg|Brigatinib 180 mg, tablets, orally once daily in each cycle of 28 days (approximately, up to 44.4 months).
233497|NCT01449461|O4|Outcome|Brigatinib 120 mg|Brigatinib 120 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
233498|NCT01449461|O3|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily or twice daily in each cycle of 28 days (approximately, up to 44.4 months).
233499|NCT01449461|O2|Outcome|Brigatinib 60 mg|Brigatinib 60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233500|NCT01449461|O1|Outcome|Brigatinib 30 mg|Brigatinib 30 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233501|NCT01449461|O1|Outcome|Dose Escalation Phase|Participants received brigatinib tablets, orally, once daily (QD) starting at 30 mg in each cycle of 28 days (approximately, up to 44.4 months).
233502|NCT01449461|O6|Outcome|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, once daily (QD) or 120 mg, twice daily (BID) or 300 mg once daily, tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
233503|NCT01449461|O5|Outcome|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, twice daily (BID), tablets, orally in each cycle of 28 days (approximately, up to 44.4 months).
233504|NCT01449461|O4|Outcome|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days.
233505|NCT01449461|O3|Outcome|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
233506|NCT01449461|O2|Outcome|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233507|NCT01449461|O1|Outcome|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233508|NCT01449461|O6|Outcome|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, once daily (QD) or 120 mg, twice daily (BID) or 300 mg once daily, tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
233509|NCT01449461|O5|Outcome|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, twice daily (BID), tablets, orally in each cycle of 28 days (approximately, up to 44.4 months).
233510|NCT01449461|O4|Outcome|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days.
233511|NCT01449461|O3|Outcome|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
233512|NCT01449461|O2|Outcome|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233513|NCT01449461|O1|Outcome|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233514|NCT01449461|O1|Outcome|Brigatinib|All participants who received brigatinib, tablets, orally, once daily in each cycle of 28 days.
233515|NCT01449461|E6|Reported Event|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, once daily (QD) or 120 mg, twice daily (BID) or 300 mg once daily, tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
233516|NCT01449461|E5|Reported Event|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, twice daily (BID), tablets, orally in each cycle of 28 days (approximately, up to 44.4 months).
233517|NCT01449461|E4|Reported Event|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days.
233518|NCT01449461|E3|Reported Event|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
233519|NCT01449461|E2|Reported Event|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233520|NCT01449461|E1|Reported Event|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
233521|NCT01449370|B26|Baseline|Total|Total of all reporting groups
233522|NCT01449370|B25|Baseline|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233665|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg|Cohort 2: TAK-117 150 mg, capsules, orally, QD, continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233523|NCT01449370|B24|Baseline|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233524|NCT01449370|B23|Baseline|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233525|NCT01449370|B22|Baseline|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233526|NCT01449370|B21|Baseline|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233527|NCT01449370|B20|Baseline|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233528|NCT01449370|B19|Baseline|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233529|NCT01449370|B18|Baseline|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233530|NCT01449370|B17|Baseline|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233531|NCT01449370|B16|Baseline|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233532|NCT01449370|B15|Baseline|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233533|NCT01449370|B14|Baseline|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233534|NCT01449370|B13|Baseline|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233535|NCT01449370|B12|Baseline|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233536|NCT01449370|B11|Baseline|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233537|NCT01449370|B10|Baseline|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233538|NCT01449370|B9|Baseline|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233539|NCT01449370|B8|Baseline|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233540|NCT01449370|B7|Baseline|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233541|NCT01449370|B6|Baseline|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233542|NCT01449370|B5|Baseline|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233543|NCT01449370|B4|Baseline|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233544|NCT01449370|B3|Baseline|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233545|NCT01449370|B2|Baseline|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233546|NCT01449370|B1|Baseline|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233547|NCT01449370|P25|Participant Flow|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233548|NCT01449370|P24|Participant Flow|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233666|NCT01449370|O1|Outcome|Process A: TAK-117 100 mg|Cohort 1: TAK-117 100 mg, capsules, orally, once a day (QD), continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233549|NCT01449370|P23|Participant Flow|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233550|NCT01449370|P22|Participant Flow|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233551|NCT01449370|P21|Participant Flow|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233552|NCT01449370|P20|Participant Flow|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233553|NCT01449370|P19|Participant Flow|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233554|NCT01449370|P18|Participant Flow|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233555|NCT01449370|P17|Participant Flow|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233556|NCT01449370|P16|Participant Flow|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233557|NCT01449370|P15|Participant Flow|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233558|NCT01449370|P14|Participant Flow|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233559|NCT01449370|P13|Participant Flow|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233560|NCT01449370|P12|Participant Flow|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233561|NCT01449370|P11|Participant Flow|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233562|NCT01449370|P10|Participant Flow|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233563|NCT01449370|P9|Participant Flow|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233564|NCT01449370|P8|Participant Flow|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233565|NCT01449370|P7|Participant Flow|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233566|NCT01449370|P6|Participant Flow|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233567|NCT01449370|P5|Participant Flow|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233568|NCT01449370|P4|Participant Flow|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233569|NCT01449370|P3|Participant Flow|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233570|NCT01449370|P2|Participant Flow|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233571|NCT01449370|P1|Participant Flow|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233572|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233573|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233574|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
234522|NCT01446289|E3|Reported Event|Infants GBS|Infants born from mothers who received one dose of GBS vaccine.
233575|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233576|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233577|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233578|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233579|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233580|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233581|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233582|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233583|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233584|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233585|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233586|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233587|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233588|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233589|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233590|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233591|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233592|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233593|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233594|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233595|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233596|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233597|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233598|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233599|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233600|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233601|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233602|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233603|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233604|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233605|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233606|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233607|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233608|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233609|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233610|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233611|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233612|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233613|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233614|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233615|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233616|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233617|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233618|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233619|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233620|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233621|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233622|NCT01449370|O15|Outcome|Process B: TAK-117 1500 mg|Cohort 21: TAK-117 1500 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233623|NCT01449370|O14|Outcome|Process B: TAK-117 1200 mg|Cohort 17: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW ; Cohort 20: TAK-117 1200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233624|NCT01449370|O13|Outcome|Process B: TAK-117 900 mg|Cohort 16: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 19: TAK-117 900 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233625|NCT01449370|O12|Outcome|Process B: TAK-117 600 mg|Cohort 15: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 18: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW; Cohort 25: TAK-117 600 mg, capsules, orally, intermittently, BID every other day on MWF QW. TAK-117 was administered in all the 3 cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233626|NCT01449370|O11|Outcome|Process B: TAK-117 500 mg|Cohort 24: TAK-117 500 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233627|NCT01449370|O10|Outcome|Process B: TAK-117 400 mg|Cohort 23: TAK-117 400 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233628|NCT01449370|O9|Outcome|Process B: TAK-117 300 mg|Cohort 22: TAK-117 300 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233629|NCT01449370|O8|Outcome|Process A: TAK-117 1200 mg|Cohort 10: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233630|NCT01449370|O7|Outcome|Process A: TAK-117 900 mg|Cohort 9: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 14: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233631|NCT01449370|O6|Outcome|Process A: TAK-117 600 mg|Cohort 8: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 13: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233632|NCT01449370|O5|Outcome|Process A: TAK-117 400 mg|Cohort 7: TAK-117 400 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 12: TAK-117 400 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233633|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg|Cohort 4: TAK-117 300 mg, capsules, orally, QD, continuously; Cohort 6: TAK-117 300 mg, capsules, orally, intermittently, once every other day on MWF QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233634|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg|Cohort 3: TAK-117 200 mg, capsules, orally, QD, continuously; Cohort 5: TAK-117 200 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 11: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in all 3 cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233635|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg|Cohort 2: TAK-117 150 mg, capsules, orally, QD, continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233636|NCT01449370|O1|Outcome|Process A: TAK-117 100 mg|Cohort 1: TAK-117 100 mg, capsules, orally, once a day (QD), continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233637|NCT01449370|O15|Outcome|Process B: TAK-117 1500 mg|Cohort 21: TAK-117 1500 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233638|NCT01449370|O14|Outcome|Process B: TAK-117 1200 mg|Cohort 17: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW ; Cohort 20: TAK-117 1200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233639|NCT01449370|O13|Outcome|Process B: TAK-117 900 mg|Cohort 16: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 19: TAK-117 900 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233640|NCT01449370|O12|Outcome|Process B: TAK-117 600 mg|Cohort 15: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 18: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW; Cohort 25: TAK-117 600 mg, capsules, orally, intermittently, BID every other day on MWF QW. TAK-117 was administered in all the 3 cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233641|NCT01449370|O11|Outcome|Process B: TAK-117 500 mg|Cohort 24: TAK-117 500 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233642|NCT01449370|O10|Outcome|Process B: TAK-117 400 mg|Cohort 23: TAK-117 400 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233643|NCT01449370|O9|Outcome|Process B: TAK-117 300 mg|Cohort 22: TAK-117 300 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233644|NCT01449370|O8|Outcome|Process A: TAK-117 1200 mg|Cohort 10: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233645|NCT01449370|O7|Outcome|Process A: TAK-117 900 mg|Cohort 9: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 14: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233704|NCT01449370|O8|Outcome|Process A: TAK-117 1200 mg|Cohort 10: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233646|NCT01449370|O6|Outcome|Process A: TAK-117 600 mg|Cohort 8: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 13: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233647|NCT01449370|O5|Outcome|Process A: TAK-117 400 mg|Cohort 7: TAK-117 400 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 12: TAK-117 400 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233648|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg|Cohort 4: TAK-117 300 mg, capsules, orally, QD, continuously; Cohort 6: TAK-117 300 mg, capsules, orally, intermittently, once every other day on MWF QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233649|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg|Cohort 3: TAK-117 200 mg, capsules, orally, QD, continuously; Cohort 5: TAK-117 200 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 11: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in all 3 cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233650|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg|Cohort 2: TAK-117 150 mg, capsules, orally, QD, continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233651|NCT01449370|O1|Outcome|Process A: TAK-117 100 mg|Cohort 1: TAK-117 100 mg, capsules, orally, once a day (QD), continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233652|NCT01449370|O15|Outcome|Process B: TAK-117 1500 mg|Cohort 21: TAK-117 1500 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233653|NCT01449370|O14|Outcome|Process B: TAK-117 1200 mg|Cohort 17: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW ; Cohort 20: TAK-117 1200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233654|NCT01449370|O13|Outcome|Process B: TAK-117 900 mg|Cohort 16: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 19: TAK-117 900 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233655|NCT01449370|O12|Outcome|Process B: TAK-117 600 mg|Cohort 15: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 18: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW; Cohort 25: TAK-117 600 mg, capsules, orally, intermittently, BID every other day on MWF QW. TAK-117 was administered in all the 3 cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233656|NCT01449370|O11|Outcome|Process B: TAK-117 500 mg|Cohort 24: TAK-117 500 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233657|NCT01449370|O10|Outcome|Process B: TAK-117 400 mg|Cohort 23: TAK-117 400 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233658|NCT01449370|O9|Outcome|Process B: TAK-117 300 mg|Cohort 22: TAK-117 300 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233659|NCT01449370|O8|Outcome|Process A: TAK-117 1200 mg|Cohort 10: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233660|NCT01449370|O7|Outcome|Process A: TAK-117 900 mg|Cohort 9: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 14: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233661|NCT01449370|O6|Outcome|Process A: TAK-117 600 mg|Cohort 8: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 13: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233662|NCT01449370|O5|Outcome|Process A: TAK-117 400 mg|Cohort 7: TAK-117 400 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 12: TAK-117 400 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233663|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg|Cohort 4: TAK-117 300 mg, capsules, orally, QD, continuously; Cohort 6: TAK-117 300 mg, capsules, orally, intermittently, once every other day on MWF QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233664|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg|Cohort 3: TAK-117 200 mg, capsules, orally, QD, continuously; Cohort 5: TAK-117 200 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 11: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in all 3 cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233667|NCT01449370|O15|Outcome|Process B: TAK-117 1500 mg|Cohort 21: TAK-117 1500 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233668|NCT01449370|O14|Outcome|Process B: TAK-117 1200 mg|Cohort 17: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW ; Cohort 20: TAK-117 1200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233669|NCT01449370|O13|Outcome|Process B: TAK-117 900 mg|Cohort 16: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 19: TAK-117 900 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233670|NCT01449370|O12|Outcome|Process B: TAK-117 600 mg|Cohort 15: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 18: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW; Cohort 25: TAK-117 600 mg, capsules, orally, intermittently, BID every other day on MWF QW. TAK-117 was administered in all the 3 cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233671|NCT01449370|O11|Outcome|Process B: TAK-117 500 mg|Cohort 24: TAK-117 500 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233672|NCT01449370|O10|Outcome|Process B: TAK-117 400 mg|Cohort 23: TAK-117 400 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233673|NCT01449370|O9|Outcome|Process B: TAK-117 300 mg|Cohort 22: TAK-117 300 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233674|NCT01449370|O8|Outcome|Process A: TAK-117 1200 mg|Cohort 10: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233675|NCT01449370|O7|Outcome|Process A: TAK-117 900 mg|Cohort 9: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 14: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233676|NCT01449370|O6|Outcome|Process A: TAK-117 600 mg|Cohort 8: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 13: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233677|NCT01449370|O5|Outcome|Process A: TAK-117 400 mg|Cohort 7: TAK-117 400 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 12: TAK-117 400 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233678|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg|Cohort 4: TAK-117 300 mg, capsules, orally, QD, continuously; Cohort 6: TAK-117 300 mg, capsules, orally, intermittently, once every other day on MWF QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233679|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg|Cohort 3: TAK-117 200 mg, capsules, orally, QD, continuously; Cohort 5: TAK-117 200 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 11: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in all 3 cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233680|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg|Cohort 2: TAK-117 150 mg, capsules, orally, QD, continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233681|NCT01449370|O1|Outcome|Process A: TAK-117 100 mg|Cohort 1: TAK-117 100 mg, capsules, orally, once a day (QD), continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233682|NCT01449370|O15|Outcome|Process B: TAK-117 1500 mg|Cohort 21: TAK-117 1500 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233683|NCT01449370|O14|Outcome|Process B: TAK-117 1200 mg|Cohort 17: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW ; Cohort 20: TAK-117 1200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233684|NCT01449370|O13|Outcome|Process B: TAK-117 900 mg|Cohort 16: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 19: TAK-117 900 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233728|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
238521|NCT01434186|B1|Baseline|Placebo|Placebo matching saxagliptin
233685|NCT01449370|O12|Outcome|Process B: TAK-117 600 mg|Cohort 15: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 18: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW; Cohort 25: TAK-117 600 mg, capsules, orally, intermittently, BID every other day on MWF QW. TAK-117 was administered in all the 3 cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233686|NCT01449370|O11|Outcome|Process B: TAK-117 500 mg|Cohort 24: TAK-117 500 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233687|NCT01449370|O10|Outcome|Process B: TAK-117 400 mg|Cohort 23: TAK-117 400 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233688|NCT01449370|O9|Outcome|Process B: TAK-117 300 mg|Cohort 22: TAK-117 300 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233689|NCT01449370|O8|Outcome|Process A: TAK-117 1200 mg|Cohort 10: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233690|NCT01449370|O7|Outcome|Process A: TAK-117 900 mg|Cohort 9: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 14: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233691|NCT01449370|O6|Outcome|Process A: TAK-117 600 mg|Cohort 8: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 13: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233692|NCT01449370|O5|Outcome|Process A: TAK-117 400 mg|Cohort 7: TAK-117 400 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 12: TAK-117 400 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233693|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg|Cohort 4: TAK-117 300 mg, capsules, orally, QD, continuously; Cohort 6: TAK-117 300 mg, capsules, orally, intermittently, once every other day on MWF QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233694|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg|Cohort 3: TAK-117 200 mg, capsules, orally, QD, continuously; Cohort 5: TAK-117 200 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 11: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in all 3 cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233695|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg|Cohort 2: TAK-117 150 mg, capsules, orally, QD, continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233696|NCT01449370|O1|Outcome|Process A: TAK-117 100 mg|Cohort 1: TAK-117 100 mg, capsules, orally, once a day (QD), continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233697|NCT01449370|O15|Outcome|Process B: TAK-117 1500 mg|Cohort 21: TAK-117 1500 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233698|NCT01449370|O14|Outcome|Process B: TAK-117 1200 mg|Cohort 17: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW ; Cohort 20: TAK-117 1200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233699|NCT01449370|O13|Outcome|Process B: TAK-117 900 mg|Cohort 16: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 19: TAK-117 900 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233700|NCT01449370|O12|Outcome|Process B: TAK-117 600 mg|Cohort 15: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 18: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW; Cohort 25: TAK-117 600 mg, capsules, orally, intermittently, BID every other day on MWF QW. TAK-117 was administered in all the 3 cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233701|NCT01449370|O11|Outcome|Process B: TAK-117 500 mg|Cohort 24: TAK-117 500 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233702|NCT01449370|O10|Outcome|Process B: TAK-117 400 mg|Cohort 23: TAK-117 400 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
233703|NCT01449370|O9|Outcome|Process B: TAK-117 300 mg|Cohort 22: TAK-117 300 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
263453|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
233705|NCT01449370|O7|Outcome|Process A: TAK-117 900 mg|Cohort 9: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 14: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233706|NCT01449370|O6|Outcome|Process A: TAK-117 600 mg|Cohort 8: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 13: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233707|NCT01449370|O5|Outcome|Process A: TAK-117 400 mg|Cohort 7: TAK-117 400 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 12: TAK-117 400 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233708|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg|Cohort 4: TAK-117 300 mg, capsules, orally, QD, continuously; Cohort 6: TAK-117 300 mg, capsules, orally, intermittently, once every other day on MWF QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233709|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg|Cohort 3: TAK-117 200 mg, capsules, orally, QD, continuously; Cohort 5: TAK-117 200 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 11: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in all 3 cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233710|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg|Cohort 2: TAK-117 150 mg, capsules, orally, QD, continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233711|NCT01449370|O1|Outcome|Process A: TAK-117 100 mg|Cohort 1: TAK-117 100 mg, capsules, orally, once a day (QD), continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
233712|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233713|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233714|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233715|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233716|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233717|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233718|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233719|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233720|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233721|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233722|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233723|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233724|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233725|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233726|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233727|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
234523|NCT01446289|E2|Reported Event|Mothers Placebo|Pregnant women who received one injection of saline solution.
233729|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233730|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233731|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233732|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233733|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233734|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233735|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233736|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233737|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233738|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233739|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233740|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233741|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233742|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233743|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233744|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233745|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233746|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233747|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233748|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233749|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233750|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233751|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233752|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233753|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233754|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233755|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233783|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233756|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233757|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233758|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233759|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233760|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233761|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233762|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233763|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233764|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233765|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233766|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233767|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233768|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233769|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233770|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233771|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233772|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233773|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233774|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233775|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233776|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233777|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233778|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233779|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233780|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233781|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233782|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
234524|NCT01446289|E1|Reported Event|Mothers GBS|Pregnant women who received one dose of GBS vaccine.
233784|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233785|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233786|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233787|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233788|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233789|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233790|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233791|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233792|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233793|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233794|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233795|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233796|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233797|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233798|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233799|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233800|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233801|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233802|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233803|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233804|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233805|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233806|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233807|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233808|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233809|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233810|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233811|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233812|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233813|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233814|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233815|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233816|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233817|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233818|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233819|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233820|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233821|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233822|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233823|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233824|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233825|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233826|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233827|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233828|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233829|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233830|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233831|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233832|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233833|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233834|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233835|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233836|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233837|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233838|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233839|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233840|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233841|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233842|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233843|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233844|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233845|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233846|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233847|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233848|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233849|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233850|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233851|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233852|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233853|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233854|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233855|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233856|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233857|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233858|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233859|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233860|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233861|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233862|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233863|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233864|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233865|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233866|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233867|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233868|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233869|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233870|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233871|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233872|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233873|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233874|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233875|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233876|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233877|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233878|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233879|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233880|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233881|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233882|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233883|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233884|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233885|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233886|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233887|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233888|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233889|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233890|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233891|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233892|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233893|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233894|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233895|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233896|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233897|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233898|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233899|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233900|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233901|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233902|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233903|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233904|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233905|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233906|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233907|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233908|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233909|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233910|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233911|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233912|NCT01449370|O6|Outcome|Process B: Total FM BID MWF QW 300-600 mg|TAK-117 300-600 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233913|NCT01449370|O5|Outcome|Process B: Total FM MTW QW 600-1500 mg|TAK-117 600-1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233914|NCT01449370|O4|Outcome|Process B: Total FM MWF QW TAK-117 600-1200 mg|TAK-117 600-1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233915|NCT01449370|O3|Outcome|Process A: Total MTW QW 200-900 mg|TAK-117 200-900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233916|NCT01449370|O2|Outcome|Process A: Total MWF QW 200-1200 mg|TAK-117 200-1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233917|NCT01449370|O1|Outcome|Process A: Total QD TAK-117 100-300 mg|TAK-117 100-300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233918|NCT01449370|E25|Reported Event|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233919|NCT01449370|E24|Reported Event|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
234000|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
238522|NCT01434186|P2|Participant Flow|Saxagliptin|saxagliptin 2.5 or 5 mg according to body weight
233920|NCT01449370|E23|Reported Event|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233921|NCT01449370|E22|Reported Event|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233922|NCT01449370|E21|Reported Event|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233923|NCT01449370|E20|Reported Event|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233924|NCT01449370|E19|Reported Event|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233925|NCT01449370|E18|Reported Event|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233926|NCT01449370|E17|Reported Event|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233927|NCT01449370|E16|Reported Event|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233928|NCT01449370|E15|Reported Event|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
233929|NCT01449370|E14|Reported Event|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233930|NCT01449370|E13|Reported Event|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233931|NCT01449370|E12|Reported Event|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233932|NCT01449370|E11|Reported Event|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233933|NCT01449370|E10|Reported Event|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233934|NCT01449370|E9|Reported Event|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233935|NCT01449370|E8|Reported Event|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233936|NCT01449370|E7|Reported Event|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233937|NCT01449370|E6|Reported Event|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233938|NCT01449370|E5|Reported Event|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
233939|NCT01449370|E4|Reported Event|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233940|NCT01449370|E3|Reported Event|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233941|NCT01449370|E2|Reported Event|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233942|NCT01449370|E1|Reported Event|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
233943|NCT01449305|B1|Baseline|Nanoone Woman Underwear|"Nanoone negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles."
233944|NCT01449305|P1|Participant Flow|Nanoone Woman Underwear|"Nanoone negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles."
234001|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
234525|NCT01446250|B1|Baseline|All Enrolled Participants|Analysis was performed on all enrolled participants.
233945|NCT01449305|O1|Outcome|Nanoone Woman Underwear|"Nanoone negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles."
233946|NCT01449305|O1|Outcome|Nanoone Woman Underwear|"Nanoone negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles."
233947|NCT01449305|E1|Reported Event|Nanoone Woman Underwear|"Nanoone negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles."
233948|NCT01449279|B1|Baseline|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.~Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.~Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
233949|NCT01449279|P1|Participant Flow|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.~Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.~Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
233950|NCT01449279|O1|Outcome|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.~Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.~Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
233951|NCT01449279|O1|Outcome|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.~Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.~Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
233952|NCT01449279|O1|Outcome|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.~Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.~Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
233953|NCT01449279|O1|Outcome|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.~Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.~Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
233954|NCT01449279|O1|Outcome|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.~Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.~Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
238523|NCT01434186|P1|Participant Flow|Placebo|Placebo matching saxagliptin
233955|NCT01449279|O1|Outcome|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.~Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.~Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
233956|NCT01449279|O1|Outcome|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.~Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.~Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
233957|NCT01449279|O1|Outcome|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.~Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.~Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
233958|NCT01449279|E1|Reported Event|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.~Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.~Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
233959|NCT01449266|B1|Baseline|Dotarem®-Injected Patients|"Male or female, aged ≥18 years~• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)~Dotarem®: Dotarem® was administered at a dose of 0.1 mmoL/kg (0.2 mL/kg)."
233960|NCT01449266|P1|Participant Flow|Dotarem® Injected Patients|"Male or female, aged ≥18 years~• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)~Dotarem®: Dotarem® was administered at a dose of 0.1 mmoL/kg (0.2 mL/kg)."
233961|NCT01449266|O1|Outcome|Dotarem® Injected Patients|"Male or female, aged ≥18 years~• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)"
233962|NCT01449266|O1|Outcome|Dotarem® Injected Patients|"Male or female, aged ≥18 years~• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)"
233963|NCT01449266|O1|Outcome|Dotarem® Injected Patients|"Male or female, aged ≥18 years~• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)"
233964|NCT01449266|O1|Outcome|Dotarem® Injected Patients|"Male or female, aged ≥18 years~• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)"
233965|NCT01449266|E1|Reported Event|Dotarem® Injected Patients|"Male or female, aged ≥18 years~• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)~Dotarem: Dotarem® was administered at a single dose of 0.1 mmoL/kg (0.2 mL/kg)."
233966|NCT01449240|B1|Baseline|No Investigational Treatment or Control Group|This was an observational study for the collection and study of CSF in patients with Hunter syndrome. No investigational treatment was given.
233967|NCT01449240|P1|Participant Flow|No Investigational Treatment or Control Group|This was an observational study for the collection and study of cerebrospinal fluid (CSF) in patients with Hunter syndrome. No investigational treatment was given.
233968|NCT01449240|O1|Outcome|No Investigational Treatment or Control Group|This was an observational study for the collection and study of CSF in patients with Hunter syndrome. No investigational treatment was given.
233969|NCT01449240|O1|Outcome|No Investigational Treatment or Control Group|This was an observational study for the collection and study of CSF in patients with Hunter syndrome. No investigational treatment was given.
233970|NCT01449240|E1|Reported Event|No Investigational Treatment or Control Group|This was an observational study for the collection and study of CSF in patients with Hunter syndrome. No investigational treatment was given. Safety analyses were performed in the Safety Population, which was defined as all patients who had undergone a procedure for CSF sample collection. This included a patient who underwent unsuccessful CSF sample collection; no CSF or urine GAG data were available for this adult patient.
233971|NCT01449006|B3|Baseline|Total|Total of all reporting groups
234592|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
233972|NCT01449006|B2|Baseline|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.~Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
233973|NCT01449006|B1|Baseline|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
233974|NCT01449006|P2|Participant Flow|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.~Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
233975|NCT01449006|P1|Participant Flow|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
233976|NCT01449006|O2|Outcome|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.~Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
233977|NCT01449006|O1|Outcome|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
233978|NCT01449006|O2|Outcome|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.~Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
233979|NCT01449006|O1|Outcome|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
233980|NCT01449006|O2|Outcome|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.~Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
233981|NCT01449006|O1|Outcome|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
233982|NCT01449006|O2|Outcome|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.~Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
233983|NCT01449006|O1|Outcome|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
233984|NCT01449006|E2|Reported Event|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.~Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
233985|NCT01449006|E1|Reported Event|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
233986|NCT01448850|B3|Baseline|Total|Total of all reporting groups
233987|NCT01448850|B2|Baseline|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
233988|NCT01448850|B1|Baseline|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
233989|NCT01448850|P2|Participant Flow|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
233990|NCT01448850|P1|Participant Flow|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
233991|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
233992|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
233993|NCT01448850|O1|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
233994|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
233995|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
233996|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
233997|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
233998|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
233999|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
238524|NCT01434186|O2|Outcome|Placebo|Saxagliptin matching placebo
234002|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
234003|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
234004|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
234005|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
234006|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
234007|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
234008|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
234009|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
234010|NCT01448850|E2|Reported Event|MEDI8968 300 mg|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 5.
234011|NCT01448850|E1|Reported Event|PLACEBO|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
234012|NCT01448707|B3|Baseline|Total|Total of all reporting groups
234013|NCT01448707|B2|Baseline|DRV/Rtv + 2NRTIs|Darunavir (DRV), ritonavir (rtv) and 2 N[t]RTIs: 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).
234014|NCT01448707|B1|Baseline|DRV/Rtv MONO|Darunavir (DRV) and ritonavir (rtv): 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
234015|NCT01448707|P2|Participant Flow|DRV/Rtv + 2NRTIs|Darunavir (DRV), ritonavir (rtv) and 2 N[t]RTIs: 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).
234016|NCT01448707|P1|Participant Flow|DRV/Rtv MONO|Darunavir (DRV) and ritonavir (rtv): 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
234017|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
234018|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
234019|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
234020|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
234021|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
234022|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
234023|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
234024|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
234025|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
234026|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
234027|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
234028|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
234029|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
234030|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
234063|NCT01448525|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
234031|NCT01448707|E2|Reported Event|DRV/Rtv + 2NRTIs|Darunavir (DRV), ritonavir (rtv) and 2 N[t]RTIs: 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).
234032|NCT01448707|E1|Reported Event|DRV/Rtv MONO|Darunavir (DRV) and ritonavir (rtv): 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
234033|NCT01448616|B4|Baseline|Total|Total of all reporting groups
234034|NCT01448616|B3|Baseline|Oral Placebo + Vaginal Placebo Gel|Participants received matching oral tab and placebo gel both to be used daily
234035|NCT01448616|B2|Baseline|Oral Placebo + Vaginal TFV Gel|Participants randomized to receive matching oral placebo tab once daily + tenofovir (TFV) 1% vaginal gel (40mg in 4ml) to be used daily
234036|NCT01448616|B1|Baseline|Oral TDF + Vaginal Placebo Gel|Participants randomized to receive 300mg Tenofovir Disaproxil Fumarate (TDF) 1 tab daily + the universal placebo vaginal gel (4ml) to be used daily.
234037|NCT01448616|P4|Participant Flow|Placebo Oral + Placebo Vaginal Gel|This group received the matching placebos to both study products
234038|NCT01448616|P3|Participant Flow|Oral Placebo + Vaginal Tenofovir 1% Gel|Participants received a matching oral placebo to study product and 40mg of TFV gel both to be used daily
234039|NCT01448616|P2|Participant Flow|Oral TDF + Vaginal Placebo Gel|"Women received daily TDF tablets at 300mg + universal placebo gel for daily application"
234040|NCT01448616|P1|Participant Flow|Observational Group|All enrolled participants completed 28 days of twice-daily genital swabbing for HSV DNA. Only women completing >90% of requested swabs were randomized.
234041|NCT01448616|O3|Outcome|Placebo Oral + Placebo Vaginal Gel|This group received the matching placebos to both study products
234042|NCT01448616|O2|Outcome|Oral Placebo + Vaginal Tenofovir 1% Gel|Participants received a matching oral placebo to study product and 40mg of TFV gel both to be used daily
234043|NCT01448616|O1|Outcome|Oral TDF + Vaginal Placebo Gel|"Women received daily TDF tablets at 300mg + universal placebo gel for daily application"
234044|NCT01448616|O3|Outcome|Placebo Oral + Placebo Vaginal Gel|This group received the matching placebos to both study products
234045|NCT01448616|O2|Outcome|Oral Placebo + Vaginal Tenofovir 1% Gel|Participants received a matching oral placebo to study product and 40mg/4ml of TFV gel both to be used daily
234046|NCT01448616|O1|Outcome|Oral TDF + Vaginal Placebo Gel|"Women received daily TDF tablets at 300mg + universal placebo gel for daily application"
234047|NCT01448616|O3|Outcome|Placebo Oral + Placebo Vaginal Gel|This group received the matching placebos to both study products
234048|NCT01448616|O2|Outcome|Oral Placebo + Vaginal Tenofovir 1% Gel|Participants received a matching oral placebo to study product and 40mg of TFV gel both to be used daily
234049|NCT01448616|O1|Outcome|Oral TDF + Vaginal Placebo Gel|"Women received daily TDF tablets at 300mg + universal placebo gel for daily application"
234050|NCT01448616|O3|Outcome|Oral Placebo + Vaginal Placebo|"placebo tablets: TDF placebo tablets are film-coated and contain denatonium benzoate, a bittering agent, in addition to other inactive ingredients. Study participants are instructed to take the one tablet, by mouth, once each day without regard to meals.~placebo gel: Study participants are instructed to insert one dose (the entire contents of one applicator) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible.~The placebo gel (known as the 'universal' placebo gel) is formulated to minimize any possible effects — negative or positive — on study endpoints."
234051|NCT01448616|O2|Outcome|Oral Placebo + Vaginal TFV Gel|"Tenofovir: Tenofovir 1% gel (w/w) is a gel formulation of tenofovir. Study participants are instructed to insert one dose (the entire contents of one applicator 40mg/4ml) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible.~placebo tablets: TDF placebo tablets are film-coated and contain denatonium benzoate, a bittering agent, in addition to other inactive ingredients. Study participants are instructed to take the one tablet, by mouth, once each day without regard to meals."
234052|NCT01448616|O1|Outcome|Oral TDF + Vaginal Placebo Gel|"tenofovir disoproxil fumarate (TDF): Oral tenofovir will be administered as tablets. TDF (Viread®) tablets contain 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil. Study participants are instructed to take the one tablet, by mouth, once each day without regard to meals.~placebo gel: Study participants are instructed to insert one dose (the entire contents of one applicator) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible.~The placebo gel (known as the 'universal' placebo gel) is formulated to minimize any possible effects — negative or positive — on study endpoints."
234053|NCT01448616|E4|Reported Event|Placebo Oral + Placebo Vaginal Gel|This group received the matching placebos to both study products
234054|NCT01448616|E3|Reported Event|Oral Placebo + Vaginal Tenofovir 1% Gel|Participants received a matching oral placebo to study product and 40mg of TFV gel both to be used daily
234055|NCT01448616|E2|Reported Event|Oral TDF + Vaginal Placebo Gel|"Women received daily TDF tablets at 300mg + universal placebo gel for daily application"
234056|NCT01448616|E1|Reported Event|Observational Group|All enrolled participants completed 28 days of twice-daily genital swabbing for HSV DNA. Only women completing >90% of requested swabs were randomized.
234057|NCT01448525|B3|Baseline|Total|Total of all reporting groups
234058|NCT01448525|B2|Baseline|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
234059|NCT01448525|B1|Baseline|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
234060|NCT01448525|P2|Participant Flow|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
234061|NCT01448525|P1|Participant Flow|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
234062|NCT01448525|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
234064|NCT01448525|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
234065|NCT01448525|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
234066|NCT01448525|E2|Reported Event|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
234067|NCT01448525|E1|Reported Event|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
234068|NCT01448486|B3|Baseline|Total|Total of all reporting groups
234069|NCT01448486|B2|Baseline|Standard of Care HAART|Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
234070|NCT01448486|B1|Baseline|Raltegravir|"Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID).~Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year."
234071|NCT01448486|P2|Participant Flow|Standard of Care HAART|Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
234072|NCT01448486|P1|Participant Flow|Raltegravir|"Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID).~Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year."
234073|NCT01448486|O2|Outcome|Standard of Care HAART|Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
234074|NCT01448486|O1|Outcome|Raltegravir|"Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID).~Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year."
234075|NCT01448486|O2|Outcome|Standard of Care HAART|Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
234076|NCT01448486|O1|Outcome|Raltegravir|"Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID).~Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year."
234077|NCT01448486|E2|Reported Event|Standard of Care HAART|Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
234078|NCT01448486|E1|Reported Event|Raltegravir|"Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID).~Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year."
234079|NCT01448356|B1|Baseline|Temperature and Humidity|All conditions were tested in a CAE chamber on the same day.
234080|NCT01448356|P1|Participant Flow|Temperature and Humidity|All conditions were tested in a CAE chamber on the same day.
234081|NCT01448356|O1|Outcome|Temperature and Humidity|average of three measurements
234082|NCT01448356|O1|Outcome|Temperature and Humidity|Tear evaporation of overall surface
234083|NCT01448356|E1|Reported Event|Temperature and Humidity|All conditions were tested in a CAE chamber on the same day.
234084|NCT01448213|B3|Baseline|Total|Total of all reporting groups
234085|NCT01448213|B2|Baseline|Prednisolone Acetate 1% Solution|"Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.~Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study."
234086|NCT01448213|B1|Baseline|Fluorometholone 0.1% Solution|"Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.~Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study."
234087|NCT01448213|P2|Participant Flow|Prednisolone Acetate 1% Solution|"Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.~Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study."
234088|NCT01448213|P1|Participant Flow|Fluorometholone 0.1% Solution|"Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.~Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study."
234089|NCT01448213|O2|Outcome|Prednisolone Acetate 1% Solution|"Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.~Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study."
263454|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
234090|NCT01448213|O1|Outcome|Fluorometholone 0.1% Solution|"Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.~Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study."
234091|NCT01448213|O2|Outcome|Prednisolone Acetate 1% Solution|"Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.~Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study."
234092|NCT01448213|O1|Outcome|Fluorometholone 0.1% Solution|"Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.~Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study."
234093|NCT01448213|E2|Reported Event|Prednisolone Acetate 1% Solution|"Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.~Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study."
234094|NCT01448213|E1|Reported Event|Fluorometholone 0.1% Solution|"Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.~Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study."
234095|NCT01448057|B3|Baseline|Total|Total of all reporting groups
234096|NCT01448057|B2|Baseline|Arm B|"Paracetamol (500 mg) tablets~Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets"
234097|NCT01448057|B1|Baseline|Arm A|"Combination Product~Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets"
234098|NCT01448057|P2|Participant Flow|Paracetamol Tablets|"Paracetamol (500 mg) tablets~Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets"
234099|NCT01448057|P1|Participant Flow|Combination Product|"Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets~Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets"
234100|NCT01448057|O2|Outcome|Arm B|"Paracetamol (500 mg) tablets~Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets"
234101|NCT01448057|O1|Outcome|Arm A|Combination Product Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
234102|NCT01448057|O2|Outcome|Arm B|"Paracetamol (500 mg) tablets~Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets"
234103|NCT01448057|O1|Outcome|Arm A|Combination Product Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
234104|NCT01448057|E2|Reported Event|Arm B|"Paracetamol (500 mg) tablets~Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets"
234105|NCT01448057|E1|Reported Event|Arm A|"Combination Product~Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets"
234106|NCT01448044|B3|Baseline|Total|Total of all reporting groups
234107|NCT01448044|B2|Baseline|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
234108|NCT01448044|B1|Baseline|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
234109|NCT01448044|P2|Participant Flow|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
234110|NCT01448044|P1|Participant Flow|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
234111|NCT01448044|O2|Outcome|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
234112|NCT01448044|O1|Outcome|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
234113|NCT01448044|O2|Outcome|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
234114|NCT01448044|O1|Outcome|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
234115|NCT01448044|O2|Outcome|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
234116|NCT01448044|O1|Outcome|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
234117|NCT01448044|O2|Outcome|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
234118|NCT01448044|O1|Outcome|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
234119|NCT01448044|O2|Outcome|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
234120|NCT01448044|O1|Outcome|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
234121|NCT01448044|E2|Reported Event|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
234122|NCT01448044|E1|Reported Event|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
234123|NCT01447927|B3|Baseline|Total|Total of all reporting groups
234124|NCT01447927|B2|Baseline|Placebo|Patients receive extended-release placebo PO QD on week 1and BID on weeks 2-12 (QAM and QPM on week 3) in the absence of unacceptable toxicity or disease progression.
234125|NCT01447927|B1|Baseline|Metformin|Patients receive extended-release metformin hydrochloride PO QD on week 1, and BID on weeks 2-12 (QAM QPM on week 3) in the absence of unacceptable toxicity or disease progression.
234126|NCT01447927|P2|Participant Flow|Placebo|Patients receive extended-release placebo orally (PO) once daily (QD) on week 1and BID on weeks 2-12 (every morning (QAM) and every evening (QPM) on week 3) in the absence of unacceptable toxicity or disease progression.
234127|NCT01447927|P1|Participant Flow|Metformin|Patients receive extended-release metformin hydrochloride orally (PO) once daily (QD) on week 1, and twice daily (BID) on weeks 2-12 (every morning (QAM) every evening (QPM) on week 3) in the absence of unacceptable toxicity or disease progression.
234128|NCT01447927|O2|Outcome|Placebo|Patients receive extended-release placebo PO QD on week 1and BID on weeks 2-12 (QAM and QPM on week 3) in the absence of unacceptable toxicity or disease progression.
234129|NCT01447927|O1|Outcome|Metformin|Patients receive extended-release metformin hydrochloride PO QD on week 1, and BID on weeks 2-12 (QAM QPM on week 3) in the absence of unacceptable toxicity or disease progression.
234130|NCT01447927|O2|Outcome|Placebo|Patients receive extended-release placebo PO QD on week 1and BID on weeks 2-12 (QAM and QPM on week 3) in the absence of unacceptable toxicity or disease progression.
234511|NCT01446289|O2|Outcome|Mothers Placebo|Pregnant women who received one injection of saline solution.
234131|NCT01447927|O1|Outcome|Metformin|Patients receive extended-release metformin hydrochloride PO QD on week 1, and BID on weeks 2-12 (QAM QPM on week 3) in the absence of unacceptable toxicity or disease progression.
234132|NCT01447927|E2|Reported Event|Metformin|Patients receive extended-release metformin hydrochloride PO QD on week 1, and BID on weeks 2-12 (QAM QPM on week 3) in the absence of unacceptable toxicity or disease progression.
234133|NCT01447927|E1|Reported Event|Placebo|Patients receive extended-release placebo PO QD on week 1and BID on weeks 2-12 (QAM and QPM on week 3) in the absence of unacceptable toxicity or disease progression.
234134|NCT01447914|B1|Baseline|Tivantinib Treatment|Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)
234135|NCT01447914|P1|Participant Flow|Tivantinib Treatment|Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)
234136|NCT01447914|O1|Outcome|Tivantinib Treatment|Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)
234137|NCT01447914|O1|Outcome|Tivantinib Treatment|Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)
234138|NCT01447914|E1|Reported Event|Tivantinib Treatment|Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)
234139|NCT01447849|B5|Baseline|Total|Total of all reporting groups
234140|NCT01447849|B4|Baseline|Controls on Placebo Then Lubiprostone|"Control group received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.~lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week"
234141|NCT01447849|B3|Baseline|Controls on Lubiprostone Then Placebo|"Control group received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.~lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week"
234142|NCT01447849|B2|Baseline|Chronic Constipation (CC)Subjects on Placebo Then Lubiprostone|"Subjects with chronic constipation (CC)received 1 week of therapy with placebo,then washed out for 1 week, then received 1 week of therapy with lubiprostone.~placebo pill: twice a day (BID) for 1 week; lubiprostone: 24mcg twice a day (BID)for 1 week"
234143|NCT01447849|B1|Baseline|Chronic Constipation(CC) Subjects on Lubiprostone Then Placebo|"Subjects with chronic constipation (CC) received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.~lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week"
234144|NCT01447849|P4|Participant Flow|Controls on Placebo Then Lubiprostone|"Control group received 1 week of therapy with placebo,then washed out for 1 week, then received 1 week of therapy with lubiprostone.~placebo pill: twice a day (BID) for 1 week; lubiprostone: 24mcg twice a day (BID)for 1 week"
234145|NCT01447849|P3|Participant Flow|Controls on Lubiprostone Then Placebo|"Control group received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.~lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week"
234146|NCT01447849|P2|Participant Flow|Chronic Constipation (CC)Subjects on Placebo Then Lubiprostone|"Subjects with chronic constipation received 1 week of therapy with placebo,then washed out for 1 week, then received 1 week of therapy with lubiprostone.~placebo pill: twice a day (BID) for 1 week; lubiprostone: 24mcg twice a day (BID)for 1 week"
234147|NCT01447849|P1|Participant Flow|Chronic Constipation (CC)Subjects on Lubiprostone Then Placebo|"Subjects with chronic constipation received 1 week of therapy with lubiprostone,then washed out for 1 week, then received 1 week of therapy with placebo.~lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week"
234148|NCT01447849|O2|Outcome|Placebo|Both controls and patients with chronic constipation received lubiprostone 24mcg twice daily for one week and placebo pills twice daily for one week in cross over design.
234149|NCT01447849|O1|Outcome|Lubiprostone 24 mcg Bid|Both controls and patients with chronic constipation received lubiprostone 24 mcg twice daily for one week and placebo pills twice daily for one week in cross over design.
234150|NCT01447849|O2|Outcome|Placebo|Both controls and patients with chronic constipation received 1 week of therapy with lubiprostone (24 mcg twice a day)and 1 week of placebo (twice a day) in crossover design
234151|NCT01447849|O1|Outcome|Lubiprostone 24 mcg BID|Both controls and patients with chronic constipation received 1 week of therapy with lubiprostone (24 mcg twice a day)and 1 week of placebo (twice a day) in crossover design
234152|NCT01447849|E4|Reported Event|Controls on Placebo Then Lubiprostone|Control group who received 1 week of therapy with placebo, then washed out for 1 week, then received 1 week of therapy with lubiprostone.
234153|NCT01447849|E3|Reported Event|Controls on Lubiprostone Then Placebo|Control group who received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.
234154|NCT01447849|E2|Reported Event|Chronic Constipation Subjects on Placebo Then Lubiprostone|Subjects with chronic constipation who received 1 week of therapy with placebo, then washed out for 1 week, then received 1 week of therapy with lubiprostone.
234155|NCT01447849|E1|Reported Event|Chronic Constipation Subjects on Lubiprostone Then Placebo|Subjects with chronic constipation who received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.
234156|NCT01447719|B1|Baseline|All Autopsy Population|Group of subjects with valid images who came to autopsy within 2 years of scan
234157|NCT01447719|P1|Participant Flow|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
234158|NCT01447719|O1|Outcome|Autopsy Within 1 Year of Scan|Group of subjects with valid images who came to autopsy within 1 year of scan
234159|NCT01447719|O1|Outcome|All Autopsy Population|Group of subjects with valid images who came to autopsy within 2 years of scan
234160|NCT01447719|O1|Outcome|All Autopsy Population|Group of subjects with valid images who came to autopsy within 2 years of scan
234161|NCT01447719|O1|Outcome|Subjects With no or Sparse Plaques at Autopsy|Group of subjects with valid images who came to autopsy within 1 year of scan and had no or sparse neuritic plaques at autopsy (no AD or possible AD)
234162|NCT01447719|O1|Outcome|Subjects With Moderate or Frequent Plaques at Autopsy|Group of subjects with valid images who came to autopsy within 1 years of scan and had moderate to frequent neuritic plaques at autopsy (probable AD or definite AD)
234163|NCT01447719|O1|Outcome|All Autopsy Population|Group of subjects with valid images who came to autopsy within 2 years of scan
234164|NCT01447719|O1|Outcome|Subjects With no or Sparse Plaques at Autopsy|Group of subjects with valid images who came to autopsy within 2 years of scan and had no or sparse neuritic plaques at autopsy (no AD or possible AD)
234165|NCT01447719|O1|Outcome|Subjects With Moderate or Frequent Plaques at Autopsy|Group of subjects with valid images who came to autopsy within 2 years of scan and had moderate to frequent neuritic plaques at autopsy (probable AD or definite AD)
234166|NCT01447719|E1|Reported Event|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
234167|NCT01447706|B3|Baseline|Total|Total of all reporting groups
234168|NCT01447706|B2|Baseline|Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
234169|NCT01447706|B1|Baseline|MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
234170|NCT01447706|P2|Participant Flow|Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
234171|NCT01447706|P1|Participant Flow|MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
234172|NCT01447706|O4|Outcome|HRG Low: MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
234173|NCT01447706|O3|Outcome|HRG Low: Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
234174|NCT01447706|O2|Outcome|HRG High: Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
234175|NCT01447706|O1|Outcome|HRG High: MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
234176|NCT01447706|O2|Outcome|Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
234177|NCT01447706|O1|Outcome|MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
234178|NCT01447706|O2|Outcome|Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
234179|NCT01447706|O1|Outcome|MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
234180|NCT01447706|E2|Reported Event|Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
234181|NCT01447706|E1|Reported Event|MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
234182|NCT01447576|B1|Baseline|Brexpiprazole+ADT|All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
234183|NCT01447576|P1|Participant Flow|Brexpiprazole +ADT|All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
234184|NCT01447576|O1|Outcome|Brexpiprazole+ADT|All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
234185|NCT01447576|O1|Outcome|Brexpiprazole+ADT|All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
234186|NCT01447576|O1|Outcome|Brexpiprazole+ADT|All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
234187|NCT01447576|E1|Reported Event|Brexpiprazole+ADT|Participants received brexpiprazole 0.25 to 3.0mg/day plus ADT.
234188|NCT01447511|B6|Baseline|Total|Total of all reporting groups
234189|NCT01447511|B5|Baseline|CYP2C9*3/*3 Genotype|Individuals with the CYP2C9*3/*3 genotype have two *3 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
234190|NCT01447511|B4|Baseline|CYP2C9*2/*3 Genotype|Individuals with the CYP2C9*2/*3 genotype have one *2 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
234191|NCT01447511|B3|Baseline|CYP2C9*1/*3 Genotype|Individuals with the CYP2C9*1/*3 genotype have one *1 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
234192|NCT01447511|B2|Baseline|CYP2C9*1B/*1B Haplotype|Individuals with the CYP2C9*1B/*1B haplotype have two *1B alleles and participated in the following periods: Control Period and Rifampin Period.
234193|NCT01447511|B1|Baseline|CYP2C9*1/*1 Genotype|This genotype is considered the wild type genotype. Individuals with the CYP2C9*1/*1 genotype have two *1 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
234194|NCT01447511|P5|Participant Flow|CYP2C9*3/*3 Genotype|Individuals with the CYP2C9*3/*3 genotype have two *3 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
234195|NCT01447511|P4|Participant Flow|CYP2C9*2/*3 Genotype|Individuals with the CYP2C9*2/*3 genotype have one *2 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
234196|NCT01447511|P3|Participant Flow|CYP2C9*1/*3 Genotype|Individuals with the CYP2C9*1/*3 genotype have one *1 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
234197|NCT01447511|P2|Participant Flow|CYP2C9*1B/*1B Haplotype|Individuals with the CYP2C9*1B/*1B haplotype have two *1B alleles and participated in the following periods: Control Period and Rifampin Period.
234198|NCT01447511|P1|Participant Flow|CYP2C9*1/*1 Genotype|This genotype is considered the wild type genotype. Individuals with the CYP2C9*1/*1 genotype have two *1 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
234199|NCT01447511|O5|Outcome|CYP2C9*3/*3 Genotype|Individuals with the CYP2C9*3/*3 genotype have two *3 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
234200|NCT01447511|O4|Outcome|CYP2C9*2/*3 Genotype|Individuals with the CYP2C9*2/*3 genotype have one *2 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
263455|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
234201|NCT01447511|O3|Outcome|CYP2C9*1/*3 Genotype|Individuals with the CYP2C9*1/*3 genotype have one *1 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
234202|NCT01447511|O2|Outcome|CYP2C9*1B/*1B Haplotype|Individuals with the CYP2C9*1B/*1B haplotype have two *1B alleles and participated in the following periods: Control Period and Rifampin Period.
234203|NCT01447511|O1|Outcome|CYP2C9*1/*1 Genotype|This genotype is considered the wild type genotype. Individuals with the CYP2C9*1/*1 genotype have two *1 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
234204|NCT01447511|E5|Reported Event|CYP2C9*3/*3 Genotype|Individuals with the CYP2C9*3/*3 genotype have two *3 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
234205|NCT01447511|E4|Reported Event|CYP2C9*2/*3 Genotype|Individuals with the CYP2C9*2/*3 genotype have one *2 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
234206|NCT01447511|E3|Reported Event|CYP2C9*1/*3 Genotype|Individuals with the CYP2C9*1/*3 genotype have one *1 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
234207|NCT01447511|E2|Reported Event|CYP2C9*1B/*1B Haplotype|Individuals with the CYP2C9*1B/*1B haplotype have two *1B alleles and participated in the following periods: Control Period and Rifampin Period.
234208|NCT01447511|E1|Reported Event|CYP2C9*1/*1 Genotype|This genotype is considered the wild type genotype. Individuals with the CYP2C9*1/*1 genotype have two *1 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
234209|NCT01447446|B7|Baseline|Total|Total of all reporting groups
234210|NCT01447446|B6|Baseline|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234211|NCT01447446|B5|Baseline|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234212|NCT01447446|B4|Baseline|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234213|NCT01447446|B3|Baseline|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234214|NCT01447446|B2|Baseline|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234215|NCT01447446|B1|Baseline|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234216|NCT01447446|P6|Participant Flow|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234217|NCT01447446|P5|Participant Flow|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234218|NCT01447446|P4|Participant Flow|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234219|NCT01447446|P3|Participant Flow|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234220|NCT01447446|P2|Participant Flow|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (pegylated interferon alfa-2b [peg-IFN Alfa-2b] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234221|NCT01447446|P1|Participant Flow|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (pegylated interferon alfa-2a [peg-IFN Alfa-2a] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234222|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234223|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234224|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234225|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234226|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (pegylated interferon alfa-2b [peg-IFN Alfa-2b] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234227|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (pegylated interferon alfa-2a [peg-IFN Alfa-2a] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234228|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234229|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234230|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234231|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234232|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (pegylated interferon alfa-2b [peg-IFN Alfa-2b] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234233|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (pegylated interferon alfa-2a [peg-IFN Alfa-2a] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234234|NCT01447446|O4|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234235|NCT01447446|O3|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234236|NCT01447446|O2|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234237|NCT01447446|O1|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234238|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234239|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234240|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234241|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234242|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234243|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234244|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234245|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234246|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234247|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234248|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234249|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234250|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234251|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234252|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234253|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234254|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234255|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234256|NCT01447446|O4|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234257|NCT01447446|O3|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234258|NCT01447446|O2|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234259|NCT01447446|O1|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234260|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234261|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234262|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234263|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234264|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234265|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234266|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234267|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234268|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234269|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234512|NCT01446289|O1|Outcome|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
234270|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234271|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234272|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234273|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234274|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234275|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234276|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234277|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234278|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234279|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234280|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234281|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234282|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234283|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234284|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234285|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234286|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234287|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234288|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234289|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234290|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234291|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234513|NCT01446289|O2|Outcome|Mothers Placebo|Pregnant women who received one injection of saline solution.
263456|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
234292|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234293|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234294|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234295|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234296|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234297|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234298|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234299|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234300|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234301|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234302|NCT01447446|E6|Reported Event|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234303|NCT01447446|E5|Reported Event|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234304|NCT01447446|E4|Reported Event|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234305|NCT01447446|E3|Reported Event|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234306|NCT01447446|E2|Reported Event|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234307|NCT01447446|E1|Reported Event|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
234308|NCT01447433|B3|Baseline|Total|Total of all reporting groups
234309|NCT01447433|B2|Baseline|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
234310|NCT01447433|B1|Baseline|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
234311|NCT01447433|P2|Participant Flow|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
234312|NCT01447433|P1|Participant Flow|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
234313|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
234314|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
234315|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
234316|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
234317|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
234318|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
234319|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
234514|NCT01446289|O1|Outcome|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
234320|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
234321|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
234322|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
234323|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
234324|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
234325|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
234326|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
234327|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
234328|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
234329|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
234330|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
234331|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
234332|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
234333|NCT01447433|E2|Reported Event|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
234334|NCT01447433|E1|Reported Event|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
234335|NCT01447420|B4|Baseline|Total|Total of all reporting groups
234336|NCT01447420|B3|Baseline|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
234337|NCT01447420|B2|Baseline|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered with peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
234338|NCT01447420|B1|Baseline|Peginterferon Alfa-2a Plus Ribavirin With Genotype – CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
234339|NCT01447420|P3|Participant Flow|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
234340|NCT01447420|P2|Participant Flow|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
234341|NCT01447420|P1|Participant Flow|Peginterferon Alfa-2a Plus Ribavirin With Genotype – CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
234342|NCT01447420|O3|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
234343|NCT01447420|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
234344|NCT01447420|O1|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
234345|NCT01447420|O3|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
234346|NCT01447420|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
234347|NCT01447420|O1|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
238525|NCT01434186|O1|Outcome|Saxagliptin|Saxagliptin 2.5 mg or 5 mg according to bodyweight
234348|NCT01447420|O3|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
234349|NCT01447420|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
234350|NCT01447420|O1|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
234351|NCT01447420|O1|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants were administered peginterferon alfa-2a 180 mcg SC weekly, 48 weeks and Ribavirin 1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg, orally daily, 48 weeks
234352|NCT01447420|O3|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
234353|NCT01447420|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
234354|NCT01447420|O1|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
234355|NCT01447420|E1|Reported Event|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants were administered peginterferon alfa-2a, 180 mcg SC weekly, 48 weeks and Ribavirin 1000 mg per day for < 75 kg and 1200 mg per day for >= 75 kg, orally daily, 48 weeks.
234356|NCT01447225|B5|Baseline|Total|Total of all reporting groups
234357|NCT01447225|B4|Baseline|MM-121 Plus Cabazitaxel|"escalating doses of MM-121 and cabazitaxel on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Cabazitaxel: administered IV at 20 mg/m2 or 25 mg/m2"
234358|NCT01447225|B3|Baseline|MM-121 Plus Pemetrexed|"pemetrexed at 500 mg/m2 with escalating doses of MM-121 on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Pemetrexed: administered IV at 500 mg/m2"
234359|NCT01447225|B2|Baseline|MM-121 Plus Carboplatin|"carboplatin at AUC 6 with escalating doses of MM-121 on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Carboplatin: administered at AUC 6"
234360|NCT01447225|B1|Baseline|MM-121 Plus Gemcitabine|"escalating doses of MM-121 and gemcitabine on Day 1 and Day 8 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV"
234361|NCT01447225|P10|Participant Flow|MM-121 Plus Cabazitaxel: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle"
234362|NCT01447225|P9|Participant Flow|MM-121 Plus Cabazitaxel: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
234363|NCT01447225|P8|Participant Flow|MM-121 Plus Cabazitaxel: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
234364|NCT01447225|P7|Participant Flow|MM-121 Plus Pemetrexed: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
234365|NCT01447225|P6|Participant Flow|MM-121 Plus Pemetrexed: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
234366|NCT01447225|P5|Participant Flow|MM-121 Plus Carboplatin: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
234367|NCT01447225|P4|Participant Flow|MM-121 Plus Carboplatin: Cohort 2|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
234368|NCT01447225|P3|Participant Flow|MM-121 Plus Carboplatin: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 6 Day 1 of every 3 week cycle"
234369|NCT01447225|P2|Participant Flow|MM-121 Plus Gemcitabine: Cohort 2|"MM-121 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Gemcitabine: 1000 mg/m2 IV on Day 1 And Day 8 of each 3-week cycle"
234370|NCT01447225|P1|Participant Flow|MM-121 Plus Gemcitabine: Cohort 1|"MM-121 20 mg/kg one-time loading dose on Cycle 1, Week 1 followed 12 mg/kg IV maintenance doses weekly for 3-week cycles~gemcitabine 1000 mg/m2 IV on Days 1 and 8 of each 3-week cycle"
234371|NCT01447225|O10|Outcome|MM-121 Plus Cabazitaxel: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle"
234372|NCT01447225|O9|Outcome|MM-121 Plus Cabazitaxel: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
234515|NCT01446289|O2|Outcome|Mothers Placebo|Pregnant women who received one injection of saline solution.
234373|NCT01447225|O8|Outcome|MM-121 Plus Cabazitaxel: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
234374|NCT01447225|O7|Outcome|MM-121 Plus Pemetrexed: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
234375|NCT01447225|O6|Outcome|MM-121 Plus Pemetrexed: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
234376|NCT01447225|O5|Outcome|MM-121 Plus Carboplatin: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
234377|NCT01447225|O4|Outcome|MM-121 Plus Carboplatin: Cohort 2|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
234378|NCT01447225|O3|Outcome|MM-121 Plus Carboplatin: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 6 Day 1 of every 3 week cycle"
234379|NCT01447225|O2|Outcome|MM-121 Plus Gemcitabine: Cohort 2|"MM-121 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Gemcitabine: 1000 mg/m2 IV on Day 1 And Day 8 of each 3-week cycle"
234380|NCT01447225|O1|Outcome|MM-121 Plus Gemcitabine: Cohort 1|"MM-121 20 mg/kg one-time loading dose on Cycle 1, Week 1 followed 12 mg/kg IV maintenance doses weekly for 3-week cycles~gemcitabine 1000 mg/m2 IV on Days 1 and 8 of each 3-week cycle"
234381|NCT01447225|O8|Outcome|MM-121 + Cisplatin: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus Cisplatin 25 mg/m2
234382|NCT01447225|O7|Outcome|MM-121 + Pemetrexed: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus pemetrexed 500 mg/m²
234383|NCT01447225|O6|Outcome|MM-121 + Carboplatin: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus carboplatin AUC 6
234384|NCT01447225|O5|Outcome|MM-121 + Gemcitabine: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose plus gemcitabine 1000mg/m² or 1250mg/m²
234385|NCT01447225|O4|Outcome|MM-121 + Cisplatin: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus Cisplatin 20 mg/m2 or 25 mg/m2
234386|NCT01447225|O3|Outcome|MM-121 + Pemetrexed: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus pemetrexed 500 mg/m²
234387|NCT01447225|O2|Outcome|MM-121 + Carboplatin: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus carboplatin AUC 6
234388|NCT01447225|O1|Outcome|MM-121 + Gemcitabine: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose plus gemcitabine 1000mg/m² or 1250mg/m²
234389|NCT01447225|O8|Outcome|MM-121 + Cisplatin: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus Cisplatin 25 mg/m2
234390|NCT01447225|O7|Outcome|MM-121 + Pemetrexed: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus pemetrexed 500 mg/m²
234391|NCT01447225|O6|Outcome|MM-121 + Carboplatin: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus carboplatin AUC 6
234392|NCT01447225|O5|Outcome|MM-121 + Gemcitabine: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose plus gemcitabine 1000mg/m² or 1250mg/m²
234393|NCT01447225|O4|Outcome|MM-121 + Cisplatin: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus Cisplatin 20 mg/m2 or 25 mg/m2
234394|NCT01447225|O3|Outcome|MM-121 + Pemetrexed: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus pemetrexed 500 mg/m²
234395|NCT01447225|O2|Outcome|MM-121 + Carboplatin: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus carboplatin AUC 6
234396|NCT01447225|O1|Outcome|MM-121 + Gemcitabine: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose plus gemcitabine 1000mg/m² or 1250mg/m²
234397|NCT01447225|O10|Outcome|MM-121 Plus Cabazitaxel: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle"
234398|NCT01447225|O9|Outcome|MM-121 Plus Cabazitaxel: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
234399|NCT01447225|O8|Outcome|MM-121 Plus Cabazitaxel: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
234400|NCT01447225|O7|Outcome|MM-121 Plus Pemetrexed: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
234401|NCT01447225|O6|Outcome|MM-121 Plus Pemetrexed: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
234402|NCT01447225|O5|Outcome|MM-121 Plus Carboplatin: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
234403|NCT01447225|O4|Outcome|MM-121 Plus Carboplatin: Cohort 2|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
234404|NCT01447225|O3|Outcome|MM-121 Plus Carboplatin: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 6 Day 1 of every 3 week cycle"
234405|NCT01447225|O2|Outcome|MM-121 Plus Gemcitabine: Cohort 2|"MM-121 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Gemcitabine: 1000 mg/m2 IV on Day 1 And Day 8 of each 3-week cycle"
234516|NCT01446289|O1|Outcome|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
234406|NCT01447225|O1|Outcome|MM-121 Plus Gemcitabine: Cohort 1|"MM-121 20 mg/kg one-time loading dose on Cycle 1, Week 1 followed 12 mg/kg IV maintenance doses weekly for 3-week cycles~gemcitabine 1000 mg/m2 IV on Days 1 and 8 of each 3-week cycle"
234407|NCT01447225|O10|Outcome|MM-121 Plus Cabazitaxel: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle"
234408|NCT01447225|O9|Outcome|MM-121 Plus Cabazitaxel: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
234409|NCT01447225|O8|Outcome|MM-121 Plus Cabazitaxel: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
234410|NCT01447225|O7|Outcome|MM-121 Plus Pemetrexed: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
234411|NCT01447225|O6|Outcome|MM-121 Plus Pemetrexed: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
234412|NCT01447225|O5|Outcome|MM-121 Plus Carboplatin: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
234413|NCT01447225|O4|Outcome|MM-121 Plus Carboplatin: Cohort 2|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
234414|NCT01447225|O3|Outcome|MM-121 Plus Carboplatin: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 6 Day 1 of every 3 week cycle"
234415|NCT01447225|O2|Outcome|MM-121 Plus Gemcitabine: Cohort 2|"MM-121 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Gemcitabine: 1000 mg/m2 IV on Day 1 And Day 8 of each 3-week cycle"
234416|NCT01447225|O1|Outcome|MM-121 Plus Gemcitabine: Cohort 1|"MM-121 20 mg/kg one-time loading dose on Cycle 1, Week 1 followed 12 mg/kg IV maintenance doses weekly for 3-week cycles~gemcitabine 1000 mg/m2 IV on Days 1 and 8 of each 3-week cycle"
234417|NCT01447225|O1|Outcome|MM-121 + Cabazitaxel|MTD of MM-121 + Cabazitaxel combination - NOTE: MTD of MM-121 for this combination provided in separate endpoint
234418|NCT01447225|O1|Outcome|MM-121 + Pemetrexed|MTD of combination of MM-121 + Pemetrexed - NOTE: MTD of MM-121 for this combination provided in separate endpoint
234419|NCT01447225|O1|Outcome|MM-121 + Carboplatin|MTD of the MM-121 + Carboplatin combination NOTE: MTD of MM-121 for this combination provided in separate endpoint
234420|NCT01447225|O1|Outcome|MM-121 + Gemcitabine|
234421|NCT01447225|O4|Outcome|MM-121 Plus Cabazitaxel|"escalating doses of MM-121 and cabazitaxel on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Cabazitaxel: administered IV at 20 mg/m2 or 25 mg/m2"
234422|NCT01447225|O3|Outcome|MM-121 Plus Pemetrexed|"pemetrexed at 500 mg/m2 with escalating doses of MM-121 on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Pemetrexed: administered IV at 500 mg/m2"
234423|NCT01447225|O2|Outcome|MM-121 Plus Carboplatin|"carboplatin at AUC 6 with escalating doses of MM-121 on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Carboplatin: administered at AUC 6"
234424|NCT01447225|O1|Outcome|MM-121 Plus Gemcitabine|"escalating doses of MM-121 and gemcitabine on Day 1 and Day 8 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Gemcitabine: administered IV at 1000 mg/m2 or 1250 mg/m2"
234425|NCT01447225|O10|Outcome|MM-121 Plus Cabazitaxel: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle"
234426|NCT01447225|O9|Outcome|MM-121 Plus Cabazitaxel: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
234427|NCT01447225|O8|Outcome|MM-121 Plus Cabazitaxel: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
234428|NCT01447225|O7|Outcome|MM-121 Plus Pemetrexed: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
234429|NCT01447225|O6|Outcome|MM-121 Plus Pemetrexed: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
234430|NCT01447225|O5|Outcome|MM-121 Plus Carboplatin: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
234431|NCT01447225|O4|Outcome|MM-121 Plus Carboplatin: Cohort 2|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
234432|NCT01447225|O3|Outcome|MM-121 Plus Carboplatin: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 6 Day 1 of every 3 week cycle"
234433|NCT01447225|O2|Outcome|MM-121 Plus Gemcitabine: Cohort 2|"MM-121 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Gemcitabine: 1000 mg/m2 IV on Day 1 And Day 8 of each 3-week cycle"
234434|NCT01447225|O1|Outcome|MM-121 Plus Gemcitabine: Cohort 1|"MM-121 20 mg/kg one-time loading dose on Cycle 1, Week 1 followed 12 mg/kg IV maintenance doses weekly for 3-week cycles~gemcitabine 1000 mg/m2 IV on Days 1 and 8 of each 3-week cycle"
263457|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
234435|NCT01447225|E4|Reported Event|MM-121 Plus Cabazitaxel|"escalating doses of MM-121 and cabazitaxel on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Cabazitaxel: administered IV at 20 mg/m2 or 25 mg/m2"
234436|NCT01447225|E3|Reported Event|MM-121 Plus Pemetrexed|"pemetrexed at 500 mg/m2 with escalating doses of MM-121 on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Pemetrexed: administered IV at 500 mg/m2"
234437|NCT01447225|E2|Reported Event|MM-121 Plus Carboplatin|"carboplatin at AUC 6 with escalating doses of MM-121 on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Carboplatin: administered at AUC 6"
234438|NCT01447225|E1|Reported Event|MM-121 Plus Gemcitabine|"escalating doses of MM-121 and gemcitabine on Day 1 and Day 8 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV"
234439|NCT01447121|B1|Baseline|Intended Users of the System|Study results from 2 subjects were excluded from all data analysis, because study staff inadvertently performed study tasks that could be considered 'training' them. (According to protocol, training was not allowed.)
234440|NCT01447121|P1|Participant Flow|Intended Users of the System|"Untrained subjects with diabetes use an investigational blood glucose monitoring system (Tatsu/Tradewind Investigational BG Monitoring System) to self-test capillary blood obtained from fingerstick.~Tatsu/Tradewind Investigational BG Monitoring System : Tradewind is a Bayer investigational meter that used an investigational sensor."
234441|NCT01447121|O1|Outcome|Study Staff|Study staff also used the investigational Blood Glucose Monitoring System (BGMS) (Tatus/Tradewind Investigational Blood Glucose Meter)
234442|NCT01447121|O1|Outcome|Intended Users of the System|"Untrained subjects with diabetes use an investigational blood glucose monitoring system (Tatsu/Tradewind Investigational BG Monitoring System) to self-test capillary blood obtained from fingerstick.~Tatsu/Tradewind Investigational BG Monitoring System : Tradewind is a Bayer investigational meter that used an investigational sensor."
234443|NCT01447121|E1|Reported Event|Intended Users of the System|"Untrained subjects with diabetes use an investigational blood glucose monitoring system (Tatsu/Tradewind Investigational BG Monitoring System) to self-test capillary blood obtained from fingerstick.~Tatsu/Tradewind Investigational BG Monitoring System : Tradewind is a Bayer investigational meter that used an investigational sensor."
234444|NCT01447017|B3|Baseline|Total|Total of all reporting groups
234445|NCT01447017|B2|Baseline|Placebo for DPK-060 Ear Drops|Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
234446|NCT01447017|B1|Baseline|DPK-060 2% Ear Drops|DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
234447|NCT01447017|P2|Participant Flow|Placebo for DPK-060 Ear Drops|Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
234448|NCT01447017|P1|Participant Flow|DPK-060 2% Ear Drops|DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
234449|NCT01447017|O2|Outcome|Placebo for DPK-060 Ear Drops|Patients randomized to treatment with Placebo for DPK-060 ear drops (0.3 mL/pipette, 3 times daily for 7 or 10 days, as applicable)
234450|NCT01447017|O1|Outcome|DPK-060 2% Ear Drops|Patients randomized to treatment with DPK-060 2% ear drops (0.3 mL/pipette, 3 times daily for 7 or 10 days, as applicable)
234451|NCT01447017|E2|Reported Event|Placebo for DPK-060 Ear Drops|Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
234452|NCT01447017|E1|Reported Event|DPK-060 2% Ear Drops|DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
234453|NCT01446796|B1|Baseline|Continuous RV Pacing|Study terminated early due to recruitment
234454|NCT01446796|P2|Participant Flow|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
234455|NCT01446796|P1|Participant Flow|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
234456|NCT01446796|O2|Outcome|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
234457|NCT01446796|O1|Outcome|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
234458|NCT01446796|O2|Outcome|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
234459|NCT01446796|O1|Outcome|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
234460|NCT01446796|O2|Outcome|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
234461|NCT01446796|O1|Outcome|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
234462|NCT01446796|O2|Outcome|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
234463|NCT01446796|O1|Outcome|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
234464|NCT01446796|E2|Reported Event|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
238526|NCT01434186|E2|Reported Event|Saxagliptin|saxagliptin 2.5 or 5 mg according to body weight
234465|NCT01446796|E1|Reported Event|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
234466|NCT01446705|B3|Baseline|Total|Total of all reporting groups
234467|NCT01446705|B2|Baseline|Enrolled in HIE|"Patients in this arm will represent Veterans seen at the Indianapolis VAMC for whom information exchange has been activated by the patient choosing to opt-in."
234468|NCT01446705|B1|Baseline|Control (Not Enrolled)|Patients in this arm will represent Veterans seen at the Indianapolis VAMC for whom information exchange has not been activated.
234469|NCT01446705|P2|Participant Flow|Patients Enrolled in HIE|"Patients in this arm will represent Veterans seen at the Indianapolis VAMC for whom information exchange has been activated by the patient choosing to opt-in."
234470|NCT01446705|P1|Participant Flow|Controls (Not Enrolled)|Patients in this arm will represent Veterans seen at the Indianapolis VA Medical Center (VAMC) for whom information exchange has not been activated.
234471|NCT01446705|O2|Outcome|Enrolled in HIE|Patients in this arm represent Veterans seen at the Indianapolis VAMC enrolled in VLER who have readily identifiable cost information. The analysis will determine any difference among baseline variables
234472|NCT01446705|O1|Outcome|Control (Not Enrolled)|Patients in this arm represent Veterans seen at the Indianapolis VAMC NOT enrolled in VLER who have readily identifiable cost information. The analysis will determine any difference among baseline variables
234473|NCT01446705|O2|Outcome|Enrolled in HIE|This group represents veterans were enrolled in Health Information Exchange via VLER
234474|NCT01446705|O1|Outcome|Control (Not Enrolled)|Patients in this group were not enrolled in Health Information Exchange.
234475|NCT01446705|E2|Reported Event|Patients Enrolled in HIE|"Patients in this arm will represent Veterans seen at the Indianapolis VAMC for whom information exchange has been activated by the patient choosing to opt-in."
234476|NCT01446705|E1|Reported Event|Controls (Not Enrolled)|Patients in this arm will represent Veterans seen at the Indianapolis VAMC for whom information exchange has not been activated.
234477|NCT01446419|B3|Baseline|Total|Total of all reporting groups
234478|NCT01446419|B2|Baseline|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
234479|NCT01446419|B1|Baseline|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
234480|NCT01446419|P2|Participant Flow|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
234481|NCT01446419|P1|Participant Flow|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
234482|NCT01446419|O2|Outcome|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
234483|NCT01446419|O1|Outcome|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
234484|NCT01446419|O2|Outcome|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
234485|NCT01446419|O1|Outcome|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
234486|NCT01446419|O2|Outcome|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
234487|NCT01446419|O1|Outcome|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
234488|NCT01446419|E2|Reported Event|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
234489|NCT01446419|E1|Reported Event|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
234490|NCT01446289|B5|Baseline|Total|Total of all reporting groups
234491|NCT01446289|B4|Baseline|Infants Placebo|Infants born from mothers who received one injection of saline solution.
234492|NCT01446289|B3|Baseline|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
234493|NCT01446289|B2|Baseline|Mothers Placebo|Pregnant women who received one injection of saline solution.
234494|NCT01446289|B1|Baseline|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
234495|NCT01446289|P4|Participant Flow|Infants Placebo|Infants born from mothers who received one injection of saline solution.
234496|NCT01446289|P3|Participant Flow|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
234497|NCT01446289|P2|Participant Flow|Mothers Placebo|Pregnant women who received one injection of saline solution.
234498|NCT01446289|P1|Participant Flow|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
234499|NCT01446289|O2|Outcome|Infants Placebo|Infants born from mothers who received one injection of saline solution.
234500|NCT01446289|O1|Outcome|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
234501|NCT01446289|O2|Outcome|Mothers Placebo|Pregnant women who received one injection of saline solution.
234502|NCT01446289|O1|Outcome|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
234503|NCT01446289|O2|Outcome|Mothers Placebo|Pregnant women who received one injection of saline solution.
234504|NCT01446289|O1|Outcome|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
234505|NCT01446289|O2|Outcome|Infants Placebo|Infants born from mothers who received one injection of saline solution.
234506|NCT01446289|O1|Outcome|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
234507|NCT01446289|O2|Outcome|Infants Placebo|Infants born from mothers who received one injection of saline solution.
234508|NCT01446289|O1|Outcome|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
234509|NCT01446289|O2|Outcome|Infants Placebo|Infants born from mothers who received one injection of saline solution.
234510|NCT01446289|O1|Outcome|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
234526|NCT01446250|P4|Participant Flow|No Intervention|Participants who had an End of Treatment Response (ETR) were followed-up for 24 weeks after the last dose of BOC triple therapy (in Treatment Period 2) and participants who did not respond for any reason or discontinued the treatment early were followed-up for 12 weeks after the last dose of BOC (in Treatment Period 2).
234527|NCT01446250|P3|Participant Flow|PEGinf + RBV|Participants who received ALV in Treatment Period 1 were put on clinical hold but continued receiving PEGinf and RBV for 4 weeks, after which they switched to BOC triple therapy in Treatment Period 2.
234528|NCT01446250|P2|Participant Flow|Boceprevir|Participants randomized to Treatment C received Boceprevir (BOC) 800 mg three times daily (TID) with PEGinf and RBV in Treatment Period 1. Participants who received ALV in Treatment Period 1 and were put on clinical hold for 4 weeks, received BOC 800 mg TID with PEGinf and RBV in Treatment Period 2.
234529|NCT01446250|P1|Participant Flow|Alisporivir|Participants randomized to Treatment A and B received Alisporivir (ALV) 400 mg twice daily (BID) with Peginterferon alfa-2a (PEGinf) and Ribavirin (RBV) in Treatment Period 1.
234530|NCT01446250|O2|Outcome|Boceprevir|Participants randomized to Treatment C received Boceprevir (BOC) 800 mg three times daily (TID) with PEGinf and RBV in Treatment Period 1. Participants who received ALV in Treatment Period 1 and were put on clinical hold for 4 weeks, received BOC 800 mg TID with PEGinf and RBV in Treatment Period 2.
234531|NCT01446250|O1|Outcome|Alisporivir|Participants randomized to Treatment A and B received Alisporivir (ALV) 400 mg twice daily (BID) with Peginterferon alfa-2a (PEGinf) and Ribavirin (RBV) in Treatment Period 1.
234532|NCT01446250|O2|Outcome|Boceprevir|Participants randomized to Treatment C received Boceprevir (BOC) 800 mg three times daily (TID) with PEGinf and RBV in Treatment Period 1. Participants who received ALV in Treatment Period 1 and were put on clinical hold for 4 weeks, received BOC 800 mg TID with PEGinf and RBV in Treatment Period 2.
234533|NCT01446250|O1|Outcome|Alisporivir|Participants randomized to Treatment A and B received Alisporivir (ALV) 400 mg twice daily (BID) with Peginterferon alfa-2a (PEGinf) and Ribavirin (RBV) in Treatment Period 1.
234534|NCT01446250|O2|Outcome|Boceprevir|Participants randomized to Treatment C received Boceprevir (BOC) 800 mg three times daily (TID) with PEGinf and RBV in Treatment Period 1. Participants who received ALV in Treatment Period 1 and were put on clinical hold for 4 weeks, received BOC 800 mg TID with PEGinf and RBV in Treatment Period 2.
234535|NCT01446250|O1|Outcome|Alisporivir|Participants randomized to Treatment A and B received Alisporivir (ALV) 400 mg twice daily (BID) with Peginterferon alfa-2a (PEGinf) and Ribavirin (RBV) in Treatment Period 1.
234536|NCT01446250|E4|Reported Event|No Intervention|AE was discovered while taking no intervention.
234537|NCT01446250|E3|Reported Event|PEGinf + RBV|AE occurred while taking only PEGinf + RBV.
234538|NCT01446250|E2|Reported Event|Boceprevir|AE occurred while taking Boceprevir + PEGinf + RBV.
234539|NCT01446250|E1|Reported Event|Alisporivir|Adverse event (AE) occurred while taking Alisporivir + PEGinf + RBV.
234540|NCT01446237|B1|Baseline|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
234541|NCT01446237|P1|Participant Flow|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (Benzoyl Peroxide[BPO]) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 percent salicylic acid [SA]) each evening over an application period of 12 weeks.
234542|NCT01446237|O1|Outcome|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
234543|NCT01446237|O1|Outcome|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
234544|NCT01446237|O1|Outcome|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
234545|NCT01446237|O1|Outcome|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
234546|NCT01446237|O1|Outcome|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
234547|NCT01446237|E1|Reported Event|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
234548|NCT01446003|B1|Baseline|All Participants|
234549|NCT01446003|P2|Participant Flow|Placebo-MK-8457 Sequence|Participants received Placebo for 10 days followed by MK-8457 100 mg BID for 10 days. Each treatment was separated by a 10-day washout.
234550|NCT01446003|P1|Participant Flow|MK-8457-Placebo Sequence|Participants received MK-8457 100 mg twice daily (BID) for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout.
234551|NCT01446003|O2|Outcome|Placebo|Participants received Placebo for 10 days followed by MK-8457 100 mg BID for 10 days. Each treatment was separated by a 10-day washout.
234552|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout.
238527|NCT01434186|E1|Reported Event|Placebo|Placebo matching saxagliptin
234553|NCT01446003|O2|Outcome|Placebo|Participants received Placebo for 10 days followed by MK-8457 100 mg BID for 10 days. Each treatment was separated by a 10-day washout.
234554|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout.
234555|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout.
234556|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout.
234557|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout.
234558|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout.
234559|NCT01446003|O2|Outcome|Placebo|Participants received Placebo for 10 days followed by MK-8457 100 mg BID for 10 days. Each treatment was separated by a 10-day washout.
234560|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout.
234561|NCT01446003|O2|Outcome|Placebo|Participants received Placebo for 10 days followed by MK-8457 100 mg BID for 10 days. Each treatment was separated by a 10-day washout.
234562|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout.
234563|NCT01446003|O2|Outcome|Placebo|Participants received Placebo for 10 days followed by MK-8457 100 mg BID for 10 days. Each treatment was separated by a 10-day washout.
234564|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout.
234565|NCT01446003|E2|Reported Event|Placebo|Participants received Placebo for MK-8457 for 10 days
234566|NCT01446003|E1|Reported Event|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days
234567|NCT01445951|B4|Baseline|Total|Total of all reporting groups
234568|NCT01445951|B3|Baseline|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
234569|NCT01445951|B2|Baseline|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
234570|NCT01445951|B1|Baseline|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
234571|NCT01445951|P3|Participant Flow|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
234572|NCT01445951|P2|Participant Flow|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
234573|NCT01445951|P1|Participant Flow|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
234574|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
234575|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
234576|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
234577|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
234578|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
234579|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
234580|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
234581|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
234582|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
234583|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
234584|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
234585|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
234586|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
234587|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
234588|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
234589|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
234590|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
234591|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
234593|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
234594|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
234595|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
234596|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
234597|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
234598|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
234599|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
234600|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
234601|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
234602|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
234603|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
234604|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
234605|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
234606|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
234607|NCT01445951|E3|Reported Event|Aspart Group|"Subjects will receive insulin aspart and remain on the basal insulin they were taking prior to study entry~Insulin Aspart in combination with a basal insulin: Injectable insulin"
234608|NCT01445951|E2|Reported Event|Technosphere® Insulin With MedTone C Inhaler|"Subjects will receive TI with the MedToneC inhaler and remain on the basal insulin they were taking prior to study entry~Technosphere® Insulin with MedTone C Inhaler: Inhalation Powder and injectable insulin"
234609|NCT01445951|E1|Reported Event|Technosphere ® Insulin-Gen2 Group|"Subject will receive Technosphere Insulin with Gen2 Inhaler and remain on the basal insulin they were taking prior to study entry~Technosphere ®Insulin with Gen2 Inhaler: Inhalation Powder and injectable insulin"
234610|NCT01445873|B1|Baseline|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234611|NCT01445873|P1|Participant Flow|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234612|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234613|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234614|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234615|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234616|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234617|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234618|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234619|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234620|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234621|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234622|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234623|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234624|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234625|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234626|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234627|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234628|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234629|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234630|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234631|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234632|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234633|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234634|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234635|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234636|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234637|NCT01445873|E1|Reported Event|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
234638|NCT01445847|B3|Baseline|Total|Total of all reporting groups
234639|NCT01445847|B2|Baseline|Placebo|Placebo group received 1 mL/10 kg bolus once inhalational gas (Desflurane) is discontinued
234640|NCT01445847|B1|Baseline|Lidocaine|Lidocaine group received 1 mL/10 kg (or 1 mg/kg) bolus once inhalational gas (Desflurane) is discontinued
238528|NCT01434121|B4|Baseline|Total|Total of all reporting groups
234641|NCT01445847|P2|Participant Flow|Placebo|Placebo group received 1 ml per 10 kg bolus once inhalational gas (Desflurane) is discontinued
234642|NCT01445847|P1|Participant Flow|Lidocaine|Lidocaine group received 1 mL/10 kg (or 1 mg/kg) bolus once inhalational gas (Desflurane) is discontinued
234643|NCT01445847|O2|Outcome|Placebo|Placebo group received 1 ml per 10 kg (0.2 mL per 2 kg) bolus once inhalational gas (Desflurane) is discontinued
234644|NCT01445847|O1|Outcome|Lidocaine|Lidocaine group received 1 mg per kg (1mL per 10kg) bolus once inhalational gas (Desflurane) is discontinued
234645|NCT01445847|E2|Reported Event|Placebo|Placebo group received 1 ml per 10 kg bolus once inhalational gas (Desflurane) is discontinued
234646|NCT01445847|E1|Reported Event|Lidocaine|Lidocaine group received 1 ml/10 kg (or 1mg/kg) bolus once inhalational gas (Desflurane) is discontinued
234647|NCT01445769|B1|Baseline|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥ 100 x 10^9/L at week 12 or ≥ 150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
234648|NCT01445769|P1|Participant Flow|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported Patients' Global Impression of Change (PGIC) score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
234649|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥ 100 x 10^9/L at week 12 or ≥ 150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
234650|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
234651|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
234652|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
234653|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
234654|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
234655|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
234672|NCT01445678|O2|Outcome|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
234673|NCT01445678|O1|Outcome|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
238678|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
234656|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
234657|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
234658|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
234659|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
234660|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
234661|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
234662|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia. Only the subjects who had Week 24 spleen volume data are summarized.
234663|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia. Only the subjects who had Week 24 spleen volume data are summarized.
234664|NCT01445769|E1|Reported Event|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
234665|NCT01445678|B3|Baseline|Total|Total of all reporting groups
234666|NCT01445678|B2|Baseline|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
234667|NCT01445678|B1|Baseline|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
234668|NCT01445678|P2|Participant Flow|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days Of the 979 treated subjects in the integrated analysis set, 497 received meropenem.
234669|NCT01445678|P1|Participant Flow|CXA-201 and Metronidazole as Treatment for cIAI|"CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days.~Of the 979 treated subjects in the integrated analysis set, 482 received CXA."
234670|NCT01445678|O2|Outcome|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
234671|NCT01445678|O1|Outcome|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
234674|NCT01445678|O2|Outcome|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
234675|NCT01445678|O1|Outcome|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
234676|NCT01445678|O2|Outcome|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
234677|NCT01445678|O1|Outcome|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
234678|NCT01445678|O2|Outcome|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
234679|NCT01445678|O1|Outcome|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
234680|NCT01445678|O2|Outcome|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
234681|NCT01445678|O1|Outcome|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
234682|NCT01445678|E2|Reported Event|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
234683|NCT01445678|E1|Reported Event|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
234684|NCT01445652|B3|Baseline|Total|Total of all reporting groups
234685|NCT01445652|B2|Baseline|Spectacles|Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
234686|NCT01445652|B1|Baseline|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months
234687|NCT01445652|P2|Participant Flow|Spectacles|Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
234688|NCT01445652|P1|Participant Flow|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months
234689|NCT01445652|O2|Outcome|Spectacles|Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
234690|NCT01445652|O1|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months
234691|NCT01445652|O2|Outcome|Spectacles|Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
234692|NCT01445652|O1|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months
234693|NCT01445652|E2|Reported Event|Spectacles|Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
234694|NCT01445652|E1|Reported Event|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months
234695|NCT01445626|B1|Baseline|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
234696|NCT01445626|P1|Participant Flow|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
234697|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
234698|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
234699|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
234700|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
234701|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
234702|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
234703|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
234704|NCT01445626|E1|Reported Event|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
234705|NCT01445613|B1|Baseline|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
234706|NCT01445613|P1|Participant Flow|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
234707|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
234708|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
234709|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
234710|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
234711|NCT01445613|O2|Outcome|In Non-octogenarian Group|Non-octogenarian: A person who is less than 80 years old.
234712|NCT01445613|O1|Outcome|In Octogenarian Group|Octogenarian: A person with age >= 80 years.
234713|NCT01445613|O2|Outcome|In Non-octogenarian Group|Non-octogenarian: A person who is less than 80 years old.
234714|NCT01445613|O1|Outcome|In Octogenarian Group|Octogenarian: A person with age >= 80 years.
234715|NCT01445613|O2|Outcome|In Asymptomatic Group|Asymptomatic Subject: Subject does not have a history of symptoms, stroke or TIA (hemispheric or ocular/Amaurosis Fugax) in the hemisphere supplied by the target vessel in the last 180 days.
234716|NCT01445613|O1|Outcome|In Symptomatic Group|Symptomatic subject: Subject with Amaurosis Fugax (a temporary (≤10 minutes) loss of vision in one eye due to insufficient blood flow to the retina), stroke or TIA (hemispheric or ocular) in the hemisphere supplied by the target vessel in the last 180-days prior to procedure.
234717|NCT01445613|O2|Outcome|Composite of Peri-procedural DS in the Asymptomatic Group|Asymptomatic Subject: Subject does not have a history of symptoms, stroke or TIA (hemispheric or ocular/Amaurosis Fugax) in the hemisphere supplied by the target vessel in the last 180 days.
234718|NCT01445613|O1|Outcome|Composite of Peri-procedural DS in the Symptomatic Group|Symptomatic subject: Subject with Amaurosis Fugax (a temporary (≤10 minutes) loss of vision in one eye due to insufficient blood flow to the retina), stroke or transient ischemic attack (TIA) (hemispheric or ocular) in the hemisphere supplied by the target vessel in the last 180-days prior to procedure.
234719|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
234720|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
234721|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
234722|NCT01445613|E1|Reported Event|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
234723|NCT01445548|B1|Baseline|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
234724|NCT01445548|P1|Participant Flow|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
234725|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
234726|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
234727|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
234728|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
234729|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
234730|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
234731|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
234732|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
234733|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
234734|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
234735|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
238679|NCT01433263|O1|Outcome|30mg/kg BYM338|
234736|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
234737|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
234738|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
234739|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
234740|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
234741|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
234742|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
234743|NCT01445548|E1|Reported Event|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
234744|NCT01445301|B4|Baseline|Total|Total of all reporting groups
234745|NCT01445301|B3|Baseline|CLDM Twice Daily|Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234746|NCT01445301|B2|Baseline|GSK2585823 Twice Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234747|NCT01445301|B1|Baseline|GSK2585823 Once Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234748|NCT01445301|P3|Participant Flow|CLDM Twice Daily|Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234749|NCT01445301|P2|Participant Flow|GSK2585823 Twice Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234750|NCT01445301|P1|Participant Flow|GSK2585823 Once Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 gram (g) containing clindamycin (CLDM) 10 milligram (mg) and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU (Finger Tip Unit).
234751|NCT01445301|O3|Outcome|CLDM Twice Daily|Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234752|NCT01445301|O2|Outcome|GSK2585823 Twice Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234753|NCT01445301|O1|Outcome|GSK2585823 Once Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234754|NCT01445301|O3|Outcome|CLDM Twice Daily|Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234755|NCT01445301|O2|Outcome|GSK2585823 Twice Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234756|NCT01445301|O1|Outcome|GSK2585823 Once Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234856|NCT01444781|O3|Outcome|Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
238680|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
234757|NCT01445301|O3|Outcome|CLDM Twice Daily|Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234758|NCT01445301|O2|Outcome|GSK2585823 Twice Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234759|NCT01445301|O1|Outcome|GSK2585823 Once Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234760|NCT01445301|O3|Outcome|CLDM Twice Daily|Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234761|NCT01445301|O2|Outcome|GSK2585823 Twice Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234762|NCT01445301|O1|Outcome|GSK2585823 Once Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234763|NCT01445301|O3|Outcome|CLDM Twice Daily|Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234764|NCT01445301|O2|Outcome|GSK2585823 Twice Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234765|NCT01445301|O1|Outcome|GSK2585823 Once Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234766|NCT01445301|O3|Outcome|CLDM Twice Daily|Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234767|NCT01445301|O2|Outcome|GSK2585823 Twice Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234768|NCT01445301|O1|Outcome|GSK2585823 Once Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234769|NCT01445301|O3|Outcome|CLDM Twice Daily|Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234770|NCT01445301|O2|Outcome|GSK2585823 Twice Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234771|NCT01445301|O1|Outcome|GSK2585823 Once Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234772|NCT01445301|O3|Outcome|CLDM Twice Daily|Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234773|NCT01445301|O2|Outcome|GSK2585823 Twice Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234774|NCT01445301|O1|Outcome|GSK2585823 Once Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234775|NCT01445301|O3|Outcome|CLDM Twice Daily|Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234776|NCT01445301|O2|Outcome|GSK2585823 Twice Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
238681|NCT01433263|O1|Outcome|30mg/kg BYM338|
234777|NCT01445301|O1|Outcome|GSK2585823 Once Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234778|NCT01445301|O3|Outcome|CLDM Twice Daily|Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234779|NCT01445301|O2|Outcome|GSK2585823 Twice Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234780|NCT01445301|O1|Outcome|GSK2585823 Once Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234781|NCT01445301|E3|Reported Event|CLDM Twice Daily|Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234782|NCT01445301|E2|Reported Event|GSK2585823 Twice Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234783|NCT01445301|E1|Reported Event|GSK2585823 Once Daily|Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
234784|NCT01445028|B3|Baseline|Total|Total of all reporting groups
234785|NCT01445028|B2|Baseline|Recurrent RD Associated With PVR|"Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy~Isotretinoin: Isotretinoin 20mg daily for 12 weeks"
234786|NCT01445028|B1|Baseline|Primary, High-risk Retinal Detachment|Isotretinoin: Isotretinoin 20mg daily for 12 weeks
234787|NCT01445028|P2|Participant Flow|Recurrent RD Associated With PVR|"Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy~Isotretinoin: Isotretinoin 20mg daily for 12 weeks"
234788|NCT01445028|P1|Participant Flow|Primary, High-risk Retinal Detachment|Isotretinoin: Isotretinoin 20mg daily for 12 weeks
234789|NCT01445028|O2|Outcome|Recurrent RD Associated With PVR|"Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy~Isotretinoin: Isotretinoin 20mg daily for 12 weeks"
234790|NCT01445028|O1|Outcome|Primary, High-risk Retinal Detachment|Isotretinoin: Isotretinoin 20mg daily for 12 weeks
234791|NCT01445028|E2|Reported Event|Recurrent RD Associated With PVR|"Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy~Isotretinoin: Isotretinoin 20mg daily for 12 weeks"
234792|NCT01445028|E1|Reported Event|Primary, High-risk Retinal Detachment|Isotretinoin: Isotretinoin 20mg daily for 12 weeks
234793|NCT01444924|B3|Baseline|Total|Total of all reporting groups
234794|NCT01444924|B2|Baseline|Placebo|"TAP block with placebo placed prior to surgery~Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline."
234795|NCT01444924|B1|Baseline|Bupivicaine|"TAP block with bupivicaine/epinephrine placed prior to surgery.~Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis"
234796|NCT01444924|P2|Participant Flow|Placebo|"TAP block with placebo placed prior to surgery~Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline."
234797|NCT01444924|P1|Participant Flow|Bupivicaine|"TAP block with bupivicaine/epinephrine placed prior to surgery.~Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis"
234798|NCT01444924|O2|Outcome|Placebo|"TAP block with placebo placed prior to surgery~Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline."
234799|NCT01444924|O1|Outcome|Bupivicaine|"TAP block with bupivicaine/epinephrine placed prior to surgery.~Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis"
234800|NCT01444924|O2|Outcome|Placebo|"TAP block with placebo placed prior to surgery~Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline."
234801|NCT01444924|O1|Outcome|Bupivicaine|"TAP block with bupivicaine/epinephrine placed prior to surgery.~Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis"
234802|NCT01444924|E2|Reported Event|Placebo|"TAP block with placebo placed prior to surgery~Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline."
234880|NCT01444651|B2|Baseline|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
234803|NCT01444924|E1|Reported Event|Bupivicaine|"TAP block with bupivicaine/epinephrine placed prior to surgery.~Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis"
234804|NCT01444911|B3|Baseline|Total|Total of all reporting groups
234805|NCT01444911|B2|Baseline|Standard of Care|"This will consist of still vaginal dilator and/or lubricant.~Vaginal Dilator: Still vaginal dilator with lubricant."
234806|NCT01444911|B1|Baseline|Vaginal Renewal Program|Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.
234807|NCT01444911|P2|Participant Flow|Standard of Care|"This will consist of still vaginal dilator and/or lubricant.~Vaginal Dilator: Still vaginal dilator with lubricant."
234808|NCT01444911|P1|Participant Flow|Vaginal Renewal Program|Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.
234809|NCT01444911|O2|Outcome|Standard of Care|"This will consist of still vaginal dilator and/or lubricant.~Vaginal Dilator: Still vaginal dilator with lubricant."
234810|NCT01444911|O1|Outcome|Vaginal Renewal Program|Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.
234811|NCT01444911|O2|Outcome|Standard of Care|"This will consist of still vaginal dilator and/or lubricant.~Vaginal Dilator: Still vaginal dilator with lubricant."
234812|NCT01444911|O1|Outcome|Vaginal Renewal Program|Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.
234813|NCT01444911|O2|Outcome|Standard of Care|"This will consist of still vaginal dilator and/or lubricant.~Vaginal Dilator: Still vaginal dilator with lubricant."
234814|NCT01444911|O1|Outcome|Vaginal Renewal Program|Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.
234815|NCT01444911|O2|Outcome|Standard of Care|"This will consist of still vaginal dilator and/or lubricant.~Vaginal Dilator: Still vaginal dilator with lubricant."
234816|NCT01444911|O1|Outcome|Vaginal Renewal Program|Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.
234817|NCT01444911|E2|Reported Event|Standard of Care|"This will consist of still vaginal dilator and/or lubricant.~Vaginal Dilator: Still vaginal dilator with lubricant."
234818|NCT01444911|E1|Reported Event|Vaginal Renewal Program|Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.
234819|NCT01444898|B1|Baseline|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
234820|NCT01444898|P1|Participant Flow|Exenatide|All subjects enrolled in this study will be given Exenatide for 6 months. The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months).
234821|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
234822|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
234823|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
234824|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
234825|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
234826|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
234827|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
238682|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
234828|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
234829|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
234830|NCT01444898|E1|Reported Event|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
234831|NCT01444781|B4|Baseline|Total|Total of all reporting groups
234832|NCT01444781|B3|Baseline|Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster Group.|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
234833|NCT01444781|B2|Baseline|DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster Group|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
234834|NCT01444781|B1|Baseline|DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster Group|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of DTaP IPV Hep B PRP T vaccine and one dose of Prevenar (PCV7)
234835|NCT01444781|P3|Participant Flow|Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
234836|NCT01444781|P2|Participant Flow|Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
234837|NCT01444781|P1|Participant Flow|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
234838|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
234839|NCT01444781|O2|Outcome|Group 2: DTaP-IPV-HepB-PRP~Tprimary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
234840|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~ T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
234841|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
234842|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
234843|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
234844|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
234845|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
234846|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
234847|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
234848|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
234849|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
234850|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
234851|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
234852|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
234853|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
234854|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
234855|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
234881|NCT01444651|B1|Baseline|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
234857|NCT01444781|O2|Outcome|Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
234858|NCT01444781|O1|Outcome|Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of DTaP IPV Hep B PRP T vaccine and one dose of Prevenar (PCV7)
234859|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
234860|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
234861|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
234862|NCT01444781|O3|Outcome|Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
234863|NCT01444781|O2|Outcome|Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
234864|NCT01444781|O1|Outcome|Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of DTaP IPV Hep B PRP T vaccine and one dose of Prevenar (PCV7)
234865|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
234866|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
234867|NCT01444781|O1|Outcome|Group 1: DTaP-IPV Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
234868|NCT01444781|O3|Outcome|Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
234869|NCT01444781|O2|Outcome|Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
234870|NCT01444781|O1|Outcome|Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of DTaP IPV Hep B PRP T vaccine and one dose of Prevenar (PCV7)
234871|NCT01444781|E3|Reported Event|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
234872|NCT01444781|E2|Reported Event|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
234873|NCT01444781|E1|Reported Event|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
234874|NCT01444742|B1|Baseline|Clofarabine + Cytarabine|"Induction:~Clofarabine 10 mg/m2 1-2 hours by vein daily for 5 days (days 1-5) Cytarabine 20 mg subcutaneously twice daily for 7 days (days 1-7)~Consolidation:~Clofarabine 10 mg/m2 1-2 hours by vein daily for 3 days (days 1-3) Cytarabine 20 mg subcutaneously twice daily for 5 days (days 1-5)~Clofarabine: Induction:~10 mg/m2 by vein over 1-2 hours daily for 5 days (days 1-5)~Consolidation:~10 mg/m2 by vein over 1-2 hours daily for 3 days (days 1-3)~Cytarabine: Induction:~20 mg subcutaneously twice daily for 7 days (days 1-7)~Consolidation:~20 mg subcutaneously twice daily for 5 days (days 1-5)"
234875|NCT01444742|P1|Participant Flow|Clofarabine + Cytarabine|"Induction:~Clofarabine 10 mg/m2 1-2 hours by vein daily for 5 days (days 1-5) Cytarabine 20 mg subcutaneously twice daily for 7 days (days 1-7)~Consolidation:~Clofarabine 10 mg/m2 1-2 hours by vein daily for 3 days (days 1-3) Cytarabine 20 mg subcutaneously twice daily for 5 days (days 1-5)~Clofarabine: Induction:~10 mg/m2 by vein over 1-2 hours daily for 5 days (days 1-5)~Consolidation:~10 mg/m2 by vein over 1-2 hours daily for 3 days (days 1-3)~Cytarabine: Induction:~20 mg subcutaneously twice daily for 7 days (days 1-7)~Consolidation:~20 mg subcutaneously twice daily for 5 days (days 1-5)"
234876|NCT01444742|O1|Outcome|Clofarabine + Cytarabine|"Induction:~Clofarabine 10 mg/m2 1-2 hours by vein daily for 5 days (days 1-5) Cytarabine 20 mg subcutaneously twice daily for 7 days (days 1-7)~Consolidation:~Clofarabine 10 mg/m2 1-2 hours by vein daily for 3 days (days 1-3) Cytarabine 20 mg subcutaneously twice daily for 5 days (days 1-5)~Clofarabine: Induction:~10 mg/m2 by vein over 1-2 hours daily for 5 days (days 1-5)~Consolidation:~10 mg/m2 by vein over 1-2 hours daily for 3 days (days 1-3)~Cytarabine: Induction:~20 mg subcutaneously twice daily for 7 days (days 1-7)~Consolidation:~20 mg subcutaneously twice daily for 5 days (days 1-5)"
234877|NCT01444742|O1|Outcome|Clofarabine + Cytarabine|"Induction:~Clofarabine 10 mg/m2 1-2 hours by vein daily for 5 days (days 1-5) Cytarabine 20 mg subcutaneously twice daily for 7 days (days 1-7)~Consolidation:~Clofarabine 10 mg/m2 1-2 hours by vein daily for 3 days (days 1-3) Cytarabine 20 mg subcutaneously twice daily for 5 days (days 1-5)~Clofarabine: Induction:~10 mg/m2 by vein over 1-2 hours daily for 5 days (days 1-5)~Consolidation:~10 mg/m2 by vein over 1-2 hours daily for 3 days (days 1-3)~Cytarabine: Induction:~20 mg subcutaneously twice daily for 7 days (days 1-7)~Consolidation:~20 mg subcutaneously twice daily for 5 days (days 1-5)"
234878|NCT01444742|E1|Reported Event|Clofarabine + Cytarabine|"Induction:~Clofarabine 10 mg/m2 1-2 hours by vein daily for 5 days (days 1-5) Cytarabine 20 mg subcutaneously twice daily for 7 days (days 1-7)~Consolidation:~Clofarabine 10 mg/m2 1-2 hours by vein daily for 3 days (days 1-3) Cytarabine 20 mg subcutaneously twice daily for 5 days (days 1-5)~Clofarabine: Induction:~10 mg/m2 by vein over 1-2 hours daily for 5 days (days 1-5)~Consolidation:~10 mg/m2 by vein over 1-2 hours daily for 3 days (days 1-3)~Cytarabine: Induction:~20 mg subcutaneously twice daily for 7 days (days 1-7)~Consolidation:~20 mg subcutaneously twice daily for 5 days (days 1-5)"
234879|NCT01444651|B3|Baseline|Total|Total of all reporting groups
234882|NCT01444651|P2|Participant Flow|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
234883|NCT01444651|P1|Participant Flow|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
234884|NCT01444651|O2|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
234885|NCT01444651|O1|Outcome|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
234886|NCT01444651|O2|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
234887|NCT01444651|O1|Outcome|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
234888|NCT01444651|O2|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
234889|NCT01444651|O1|Outcome|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
234890|NCT01444651|O2|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
234891|NCT01444651|O1|Outcome|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
234892|NCT01444651|O2|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
234893|NCT01444651|O1|Outcome|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
234894|NCT01444651|O2|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
234895|NCT01444651|O1|Outcome|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
234896|NCT01444651|E2|Reported Event|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
234897|NCT01444651|E1|Reported Event|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
234898|NCT01444456|B1|Baseline|Darbepoetin Alfa or Other ESA|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice.
234899|NCT01444456|P1|Participant Flow|Darbepoetin Alfa or Other ESA|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice.
234900|NCT01444456|O1|Outcome|Darbepoetin Alfa|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
234901|NCT01444456|O1|Outcome|Darbepoetin Alfa|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
234902|NCT01444456|O1|Outcome|Darbepoetin Alfa|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
234903|NCT01444456|O1|Outcome|Darbepoetin Alfa|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
234904|NCT01444456|O1|Outcome|Darbepoetin Alfa|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
234905|NCT01444456|O1|Outcome|Darbepoetin Alfa|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
234906|NCT01444456|E1|Reported Event|Darbepoetin Alfa or Other ESA|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice.
234907|NCT01444430|B3|Baseline|Total|Total of all reporting groups
234908|NCT01444430|B2|Baseline|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
234909|NCT01444430|B1|Baseline|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
234910|NCT01444430|P2|Participant Flow|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
234911|NCT01444430|P1|Participant Flow|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
234912|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
234913|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
234914|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
234915|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
234916|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
234917|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
234918|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
234919|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
234920|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
234921|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
234922|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
234923|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
234924|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
234925|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
234926|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
234927|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
234928|NCT01444430|E2|Reported Event|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
234929|NCT01444430|E1|Reported Event|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
234930|NCT01444417|B3|Baseline|Total|Total of all reporting groups
234931|NCT01444417|B2|Baseline|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
234932|NCT01444417|B1|Baseline|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
234933|NCT01444417|P2|Participant Flow|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
234934|NCT01444417|P1|Participant Flow|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
234935|NCT01444417|O2|Outcome|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
234936|NCT01444417|O1|Outcome|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
234937|NCT01444417|O2|Outcome|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
234938|NCT01444417|O1|Outcome|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
234939|NCT01444417|O2|Outcome|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
234940|NCT01444417|O1|Outcome|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
234941|NCT01444417|O2|Outcome|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
234943|NCT01444417|O2|Outcome|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
234944|NCT01444417|O1|Outcome|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
234945|NCT01444417|O2|Outcome|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
234946|NCT01444417|O1|Outcome|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
234947|NCT01444417|E2|Reported Event|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
234948|NCT01444417|E1|Reported Event|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
234949|NCT01444391|B1|Baseline|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
234950|NCT01444391|P1|Participant Flow|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
234951|NCT01444391|O1|Outcome|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
234952|NCT01444391|O1|Outcome|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
234953|NCT01444391|O1|Outcome|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
234954|NCT01444391|O1|Outcome|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
234955|NCT01444391|O1|Outcome|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
234956|NCT01444391|E1|Reported Event|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
234957|NCT01444378|B1|Baseline|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234958|NCT01444378|P1|Participant Flow|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234959|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234960|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234961|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234962|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234963|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234964|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234965|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234966|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234967|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234968|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234969|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234970|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
238683|NCT01433263|O1|Outcome|30mg/kg BYM338|
234971|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234972|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234973|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234974|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234975|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234976|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234977|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234978|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234979|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234980|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234981|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234982|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234983|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234984|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234985|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234986|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234987|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234988|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234989|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234990|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234991|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234992|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234993|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234994|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234995|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234996|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234997|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234998|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
234999|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235000|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235001|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235002|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235003|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235004|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235005|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235006|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235007|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235008|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235009|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235010|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235011|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235012|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235013|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235014|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235015|NCT01444378|O3|Outcome|Stair Climbing Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235016|NCT01444378|O2|Outcome|Walking Speed Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235017|NCT01444378|O1|Outcome|Walking Distance Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235018|NCT01444378|O3|Outcome|Stair Climbing Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235019|NCT01444378|O2|Outcome|Walking Speed Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235020|NCT01444378|O1|Outcome|Walking Distance Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235021|NCT01444378|O3|Outcome|Stair Climbing Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235022|NCT01444378|O2|Outcome|Walking Speed Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235023|NCT01444378|O1|Outcome|Walking Distance Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235024|NCT01444378|O3|Outcome|Stair Climbing Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235025|NCT01444378|O2|Outcome|Walking Speed Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
238684|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
235026|NCT01444378|O1|Outcome|Walking Distance Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235027|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235028|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235029|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235030|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235031|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235032|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235033|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235034|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235035|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235036|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235037|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235038|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235039|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235040|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235041|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235042|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235043|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235044|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235045|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235046|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235047|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235048|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235049|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235050|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235051|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235052|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
238685|NCT01433263|O1|Outcome|30mg/kg BYM338|
235053|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235054|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235055|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235056|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235057|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235058|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235059|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235060|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235061|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235062|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235063|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235064|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235065|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235066|NCT01444378|E1|Reported Event|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
235067|NCT01444300|B3|Baseline|Total|Total of all reporting groups
235068|NCT01444300|B2|Baseline|Placebo|Placebo: placebo pill, twice daily (bid), for 12 weeks
235069|NCT01444300|B1|Baseline|Dalfampridine|Dalfampridine: 10mg, twice daily (bid), pill taken by mouth for 12 weeks
235070|NCT01444300|P2|Participant Flow|Placebo|Placebo: placebo pill, twice daily, for 12 weeks
235071|NCT01444300|P1|Participant Flow|Dalfampridine|Dalfampridine: 10mg, twice daily, pill taken by mouth for 12 weeks
235072|NCT01444300|O2|Outcome|Placebo|Placebo: placebo pill, twice daily (bid), pill taken by mouth for for 12 weeks
235073|NCT01444300|O1|Outcome|Dalfampridine|Dalfampridine: 10mg, twice daily (bid), pill taken by mouth for 12 weeks
235074|NCT01444300|O2|Outcome|Placebo|Placebo: placebo pill, twice daily (bid), pill taken by mouth for 12 weeks
235075|NCT01444300|O1|Outcome|Dalfampridine|Dalfampridine: 10mg, twice daily (bid), pill taken by mouth for 12 weeks
235076|NCT01444300|O2|Outcome|Placebo|Placebo: placebo pill, twice daily (bid), pill taken by mouth for 12 weeks
235077|NCT01444300|O1|Outcome|Dalfampridine|Dalfampridine: 10mg, twice daily (bid), pill taken by mouth for 12 weeks
235078|NCT01444300|E2|Reported Event|Placebo|Placebo: placebo pill, twice daily, for 12 weeks
235079|NCT01444300|E1|Reported Event|Dalfampridine|Dalfampridine: 10mg, twice daily, pill taken by mouth for 12 weeks
235080|NCT01444287|B1|Baseline|All Subjects|Subjects who were enrolled and randomized to a trial arm.
235081|NCT01444287|P1|Participant Flow|All Study Participants|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations. The four arms were Spectacles (no contact lenses), Narafilcon B, Polymacon A, and Lotrafilcon A, in random order during the sessions.
235082|NCT01444287|O4|Outcome|Lotrafilcon A (Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
235083|NCT01444287|O3|Outcome|Polymacon (+ Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
235084|NCT01444287|O2|Outcome|Narafilcon B (Test)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
235085|NCT01444287|O1|Outcome|Spectacles No Lenses (Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
235086|NCT01444287|O4|Outcome|Lotrafilcon A (Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
235087|NCT01444287|O3|Outcome|Polymacon (+ Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
235088|NCT01444287|O2|Outcome|Narafilcon B (Test)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
235089|NCT01444287|O1|Outcome|Spectacles No Lenses (Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
235090|NCT01444287|O4|Outcome|Lotrafilcon A|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
235091|NCT01444287|O3|Outcome|Polymacon|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
235092|NCT01444287|O2|Outcome|Narafilcon B|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
235093|NCT01444287|O1|Outcome|Spectacles No Lenses|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
235094|NCT01444287|O4|Outcome|Lotrafilcon A|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
235095|NCT01444287|O3|Outcome|Polymacon|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
235096|NCT01444287|O2|Outcome|Narafilcon B|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
235097|NCT01444287|O1|Outcome|Spectacles No Lenses|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
235098|NCT01444287|E4|Reported Event|Lotrafilcon A|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
235099|NCT01444287|E3|Reported Event|Polymacon A|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
235100|NCT01444287|E2|Reported Event|Narafilcon B|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
235101|NCT01444287|E1|Reported Event|Spectacles No Lenses|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
235102|NCT01444092|B1|Baseline|Entocort|Entocort™ EC 9/6/3 mg
235103|NCT01444092|P1|Participant Flow|Entocort|Entocort™ EC 9/6/3 mg
235104|NCT01444092|O1|Outcome|Entocort|Entocort™ EC 9/6/3 mg
235105|NCT01444092|O1|Outcome|Entocort|Entocort™ EC 9/6/3 mg
235106|NCT01444092|O1|Outcome|Entocort|Entocort™ EC 9/6/3 mg
235107|NCT01444092|E1|Reported Event|Entocort|Entocort™ EC 9/6/3 mg
235108|NCT01444027|B4|Baseline|Total|Total of all reporting groups
235109|NCT01444027|B3|Baseline|Intervention Group 2 (Video)|"This group receives Problem Solving Therapy via video.~Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist."
235110|NCT01444027|B2|Baseline|Intervention Group 1 (Face to Face)|"This group receives Problem Solving Therapy in face to face visits.~Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist."
235111|NCT01444027|B1|Baseline|Attention Control|"This group receives standard care with the attention of social support/ friendly interactions and serves as an attention control group."
235112|NCT01444027|P3|Participant Flow|Intervention Group 2 (Video)|"This group receives Problem Solving Therapy via video.~Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist."
235113|NCT01444027|P2|Participant Flow|Intervention Group 1 (Face to Face)|"This group receives Problem Solving Therapy in face to face visits.~Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist."
235114|NCT01444027|P1|Participant Flow|Attention Control|"This group receives standard care with the attention of social support/ friendly interactions and serves as an attention control group."
235115|NCT01444027|O3|Outcome|Intervention Group 2 (Video)|"This group receives Problem Solving Therapy via video.~Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist."
235116|NCT01444027|O2|Outcome|Intervention Group 1 (Face to Face)|"This group receives Problem Solving Therapy in face to face visits.~Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist."
235117|NCT01444027|O1|Outcome|Attention Control|"This group receives standard care with the attention of social support/ friendly interactions and serves as an attention control group."
235136|NCT01443923|P2|Participant Flow|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
235137|NCT01443923|P1|Participant Flow|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
235118|NCT01444027|O3|Outcome|Intervention Group 2 (Video)|"This group receives Problem Solving Therapy via video.~Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist."
235119|NCT01444027|O2|Outcome|Intervention Group 1 (Face to Face)|"This group receives Problem Solving Therapy in face to face visits.~Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist."
235120|NCT01444027|O1|Outcome|Attention Control|"This group receives standard care with the attention of social support/ friendly interactions and serves as an attention control group."
235121|NCT01444027|O3|Outcome|Intervention Group 2 (Video)|"This group receives Problem Solving Therapy via video.~Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist."
235122|NCT01444027|O2|Outcome|Intervention Group 1 (Face to Face)|"This group receives Problem Solving Therapy in face to face visits.~Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist."
235123|NCT01444027|O1|Outcome|Attention Control|"This group receives standard care with the attention of social support/ friendly interactions and serves as an attention control group."
235124|NCT01444027|O3|Outcome|Intervention Group 2 (Video)|"This group receives Problem Solving Therapy via video.~Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist."
235125|NCT01444027|O2|Outcome|Intervention Group 1 (Face to Face)|"This group receives Problem Solving Therapy in face to face visits.~Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist."
235126|NCT01444027|O1|Outcome|Attention Control|"This group receives standard care with the attention of social support/ friendly interactions and serves as an attention control group."
235127|NCT01444027|O3|Outcome|Intervention Group 2 (Video)|"This group receives Problem Solving Therapy via video.~Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist."
235128|NCT01444027|O2|Outcome|Intervention Group 1 (Face to Face)|"This group receives Problem Solving Therapy in face to face visits.~Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist."
235129|NCT01444027|O1|Outcome|Attention Control|"This group receives standard care with the attention of social support/ friendly interactions and serves as an attention control group."
235130|NCT01444027|E3|Reported Event|Intervention Group 2 (Video)|"This group receives Problem Solving Therapy via video.~Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist."
235131|NCT01444027|E2|Reported Event|Intervention Group 1 (Face to Face)|"This group receives Problem Solving Therapy in face to face visits.~Problem Solving Therapy: Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist."
235132|NCT01444027|E1|Reported Event|Attention Control|"This group receives standard care with the attention of social support/ friendly interactions and serves as an attention control group."
235133|NCT01443923|B3|Baseline|Total|Total of all reporting groups
235134|NCT01443923|B2|Baseline|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
235138|NCT01443923|O2|Outcome|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
235139|NCT01443923|O1|Outcome|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
235140|NCT01443923|O2|Outcome|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
235141|NCT01443923|O1|Outcome|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
235142|NCT01443923|O2|Outcome|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
235143|NCT01443923|O1|Outcome|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
235144|NCT01443923|O2|Outcome|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
235145|NCT01443923|O1|Outcome|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
235146|NCT01443923|O2|Outcome|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
235147|NCT01443923|O1|Outcome|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
235148|NCT01443923|E2|Reported Event|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
235149|NCT01443923|E1|Reported Event|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
235150|NCT01443858|B4|Baseline|Total|Total of all reporting groups
235151|NCT01443858|B3|Baseline|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
235152|NCT01443858|B2|Baseline|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
235153|NCT01443858|B1|Baseline|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
235154|NCT01443858|P3|Participant Flow|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
235155|NCT01443858|P2|Participant Flow|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
235156|NCT01443858|P1|Participant Flow|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
235157|NCT01443858|O3|Outcome|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
235187|NCT01443845|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
235188|NCT01443845|E2|Reported Event|Roflumilast|Roflumilast 500 µg, oral administration, once per day
235189|NCT01443845|E1|Reported Event|Placebo|Dose-matched placebo, oral administration, once per day.
238686|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
235158|NCT01443858|O2|Outcome|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
235159|NCT01443858|O1|Outcome|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
235160|NCT01443858|O3|Outcome|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
235161|NCT01443858|O2|Outcome|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
235162|NCT01443858|O1|Outcome|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
235163|NCT01443858|O3|Outcome|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
235164|NCT01443858|O2|Outcome|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
235165|NCT01443858|O1|Outcome|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
235166|NCT01443858|O3|Outcome|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
235190|NCT01443494|B1|Baseline|Septic Shock Patients Despite EGDT With Hypertension|Patients with previous hypertension requiring norepinephrine to maintain a MAP of 65 mm Hg despite fluid resuscitation to central venous pressure above 8 mm Hg.
235191|NCT01443494|P1|Participant Flow|Septic Shock Patients Despite EGDT With Hypertension|Patients with previous hypertension requiring norepinephrine to maintain a MAP of 65 mm Hg despite fluid resuscitation to central venous pressure above 8 mm Hg.
238687|NCT01433263|O1|Outcome|30mg/kg BYM338|
235167|NCT01443858|O2|Outcome|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
235168|NCT01443858|O1|Outcome|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
235169|NCT01443858|O3|Outcome|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
235170|NCT01443858|O2|Outcome|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
235171|NCT01443858|O1|Outcome|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
235172|NCT01443858|E3|Reported Event|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
235173|NCT01443858|E2|Reported Event|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
235174|NCT01443858|E1|Reported Event|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
235175|NCT01443845|B3|Baseline|Total|Total of all reporting groups
235176|NCT01443845|B2|Baseline|Roflumilast|Roflumilast 500 µg, oral administration, once per day
235177|NCT01443845|B1|Baseline|Placebo|Dose-matched placebo, oral administration, once per day.
235178|NCT01443845|P2|Participant Flow|Roflumilast|Roflumilast 500 µg, oral administration, once per day
235179|NCT01443845|P1|Participant Flow|Placebo|Dose-matched placebo, oral administration, once per day.
235180|NCT01443845|O2|Outcome|Roflumilast|Roflumilast 500 µg, oral administration, once per day
235181|NCT01443845|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
235182|NCT01443845|O2|Outcome|Roflumilast|Roflumilast 500 µg, oral administration, once per day
235183|NCT01443845|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
235184|NCT01443845|O2|Outcome|Roflumilast|Roflumilast 500 µg, oral administration, once per day
235185|NCT01443845|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
235186|NCT01443845|O2|Outcome|Roflumilast|Roflumilast 500 µg, oral administration, once per day
238688|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
235192|NCT01443494|O1|Outcome|Septic Shock Patients Despite EGDT|After stabilization for 30 min, basal measurements including hemodynamic and microcirculatory measurements were taken, 20 min apart, the NE doses were increased to titrate MAP to the target level. Patients were allowed to stabilize for 30 min before taking new measurements.
235193|NCT01443494|O1|Outcome|Septic Shock Patients Despite EGDT|After stabilization for 30 min, basal measurements including hemodynamic and microcirculatory measurements were taken, 20 min apart, the NE doses were increased to titrate MAP to the target level. Patients were allowed to stabilize for 30 min before taking new measurements.
235194|NCT01443494|E1|Reported Event|Septic Shock Patients Despite EGDT|Patients requiring norepinephrine to maintain a MAP of 65 mm Hg despite fluid resuscitation to central venous pressure above 8 mm Hg.
235195|NCT01443403|B5|Baseline|Total|Total of all reporting groups
235196|NCT01443403|B4|Baseline|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235197|NCT01443403|B3|Baseline|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235198|NCT01443403|B2|Baseline|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235199|NCT01443403|B1|Baseline|Placebo|Participants received placebo orally once daily for 28 days.
235200|NCT01443403|P4|Participant Flow|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235201|NCT01443403|P3|Participant Flow|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235202|NCT01443403|P2|Participant Flow|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235203|NCT01443403|P1|Participant Flow|Placebo|Participants received placebo orally once daily for 28 days.
235204|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235205|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235206|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235207|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235208|NCT01443403|O3|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235209|NCT01443403|O2|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235210|NCT01443403|O1|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235211|NCT01443403|O3|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235212|NCT01443403|O2|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235213|NCT01443403|O1|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235214|NCT01443403|O3|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235215|NCT01443403|O2|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235216|NCT01443403|O1|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235217|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235218|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235219|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235220|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235221|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235222|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235223|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235224|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235225|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235226|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235227|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235228|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235229|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235230|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235231|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235232|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235233|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235234|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235235|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235236|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235237|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235238|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235239|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235240|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235241|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235242|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235243|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235244|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235245|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235246|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235247|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235248|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235249|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235250|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235251|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235252|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235253|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235254|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235255|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235256|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235257|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235258|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235259|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235260|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235261|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235262|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235263|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235264|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235265|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235266|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235267|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235268|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235269|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235270|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235271|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235272|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235273|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235274|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235275|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235276|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235277|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235278|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235279|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235280|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235281|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235282|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235283|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235284|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235285|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235286|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235287|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235288|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235289|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235290|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235291|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235292|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235293|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235294|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235295|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235296|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235297|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235298|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235299|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235300|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235301|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235302|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235303|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235304|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235305|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235306|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235307|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235308|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235309|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235310|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235311|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235312|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235313|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235314|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235315|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235316|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235317|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235318|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235319|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235320|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235321|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235322|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235323|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235324|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235325|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235326|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235327|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235328|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235329|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235330|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235331|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235332|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235333|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235334|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235335|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235336|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235337|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235338|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235339|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235340|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235341|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235342|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235343|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235344|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
235345|NCT01443403|E4|Reported Event|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
235346|NCT01443403|E3|Reported Event|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
235347|NCT01443403|E2|Reported Event|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
235348|NCT01443403|E1|Reported Event|Placebo|Participants received placebo orally once daily for 28 days.
235349|NCT01443364|B1|Baseline|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235350|NCT01443364|P1|Participant Flow|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235351|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235474|NCT01443130|B5|Baseline|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
238689|NCT01433263|O1|Outcome|30mg/kg BYM338|
235352|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235353|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235354|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235355|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235356|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235357|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235358|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235359|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235360|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235361|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235362|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235363|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235364|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235365|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235366|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235367|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235368|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235369|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235370|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235371|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235475|NCT01443130|B4|Baseline|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
235372|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235373|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235374|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235375|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235376|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235377|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235378|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235379|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235380|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235381|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235382|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235383|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235384|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235385|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235386|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235387|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235388|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235389|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235390|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235391|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235588|NCT01442493|B3|Baseline|Total|Total of all reporting groups
238690|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
235392|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235393|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235394|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235395|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235396|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235397|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235398|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235399|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235400|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235401|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235402|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235403|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235404|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235405|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235406|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235407|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235408|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235409|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235410|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235411|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235638|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications
238691|NCT01433263|O1|Outcome|30mg/kg BYM338|
235412|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235413|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235414|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235415|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235416|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235417|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235418|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235419|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235420|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235421|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235422|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235423|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235424|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235425|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235426|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235427|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235428|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235429|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235430|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235431|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235639|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
235432|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235433|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235434|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235435|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235436|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235437|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235438|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235439|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235440|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235441|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235442|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235443|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235444|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235445|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235446|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235447|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235448|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235449|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235450|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235451|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235640|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications
263458|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
235452|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235453|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235454|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235455|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235456|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235457|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235458|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235459|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235460|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235461|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235462|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235463|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235464|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235465|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235466|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235467|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235468|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235469|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235470|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235471|NCT01443364|E1|Reported Event|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
235472|NCT01443130|B7|Baseline|Total|Total of all reporting groups
235473|NCT01443130|B6|Baseline|Infant SP IPT|Infants born to maternal participants who received SP IPT.
235476|NCT01443130|B3|Baseline|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235477|NCT01443130|B2|Baseline|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235478|NCT01443130|B1|Baseline|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
235479|NCT01443130|P6|Participant Flow|Infant SP IPT|Infants born to maternal participants who received SP IPT.
235480|NCT01443130|P5|Participant Flow|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
235481|NCT01443130|P4|Participant Flow|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
235482|NCT01443130|P3|Participant Flow|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235483|NCT01443130|P2|Participant Flow|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235484|NCT01443130|P1|Participant Flow|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
235485|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235486|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235487|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
235488|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235489|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235490|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
235491|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235492|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235493|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
235494|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235495|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235496|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
235497|NCT01443130|O3|Outcome|Infant SP IPT|Infants born to maternal participants who received SP IPT.
235498|NCT01443130|O2|Outcome|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
235499|NCT01443130|O1|Outcome|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
235500|NCT01443130|O3|Outcome|Infant SP IPT|Infants born to maternal participants who received SP IPT.
235501|NCT01443130|O2|Outcome|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
235502|NCT01443130|O1|Outcome|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
235503|NCT01443130|O3|Outcome|Infant SP IPT|Infants born to maternal participants who received SP IPT.
235504|NCT01443130|O2|Outcome|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
235505|NCT01443130|O1|Outcome|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
235506|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235507|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235508|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
238692|NCT01433263|E5|Reported Event|Follow-up - 30mg/kg BYM338 Late|Follow-up - 30mg/kg BYM338 Late
235509|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235510|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235511|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
235512|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235513|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235514|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
235515|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235516|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235517|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
235518|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235519|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235520|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
235521|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235522|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235523|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
235524|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235525|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235526|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
235527|NCT01443130|E6|Reported Event|Infant SP IPT|Infants born to maternal participants who received SP IPT.
235528|NCT01443130|E5|Reported Event|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
235529|NCT01443130|E4|Reported Event|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
235530|NCT01443130|E3|Reported Event|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235531|NCT01443130|E2|Reported Event|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
235532|NCT01443130|E1|Reported Event|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
235533|NCT01443078|B1|Baseline|All Patients|Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
235534|NCT01443078|P1|Participant Flow|All Patients|Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
235535|NCT01443078|O1|Outcome|All Patients|Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
235536|NCT01443078|E1|Reported Event|All Patients|Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
235537|NCT01443026|B3|Baseline|Total|Total of all reporting groups
235538|NCT01443026|B2|Baseline|Placebo|Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)
235539|NCT01443026|B1|Baseline|Lycopene|Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)
235540|NCT01443026|P2|Participant Flow|Placebo|"Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)~Lycopene 30 mg or Placebo: Taken until clinically-indicated repeat biopsy performed (approximately 6 months)"
238693|NCT01433263|E4|Reported Event|Follow-up - Placebo|Follow-up - Placebo
235541|NCT01443026|P1|Participant Flow|Lycopene|"Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)~Lycopene 30 mg or Placebo: Taken until clinically-indicated repeat biopsy performed (approximately 6 months)"
235542|NCT01443026|O2|Outcome|Placebo|Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)
235543|NCT01443026|O1|Outcome|Lycopene|Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)
235544|NCT01443026|E2|Reported Event|Placebo|Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)
235545|NCT01443026|E1|Reported Event|Lycopene|Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)
235546|NCT01442844|B3|Baseline|Total|Total of all reporting groups
235547|NCT01442844|B2|Baseline|No Intervention|No intervention will be performed. Subject will receive dressings that are standard of care.
235548|NCT01442844|B1|Baseline|Micrografting|"Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound.~Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound."
235549|NCT01442844|P2|Participant Flow|No Intervention|No intervention will be performed. Subject will receive dressings that are standard of care.
235550|NCT01442844|P1|Participant Flow|Micrografting|"Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound.~Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound."
235551|NCT01442844|O2|Outcome|No Intervention|No intervention will be performed. Subject will receive dressings that are standard of care.
235552|NCT01442844|O1|Outcome|Micrografting|"Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound.~Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound."
235553|NCT01442844|E2|Reported Event|No Intervention|No intervention will be performed. Subject will receive dressings that are standard of care.
235554|NCT01442844|E1|Reported Event|Micrografting|"Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound.~Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound."
235555|NCT01442779|B1|Baseline|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
235556|NCT01442779|P1|Participant Flow|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
235557|NCT01442779|O1|Outcome|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
235558|NCT01442779|O1|Outcome|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
235559|NCT01442779|O1|Outcome|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
235560|NCT01442779|E1|Reported Event|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
235561|NCT01442714|B1|Baseline|Azacitidine Plus Lenalidomide|Azacitidine + Lenalidomide Combo
235562|NCT01442714|P1|Participant Flow|Azacitidine Plus Lenalidomide|"Patients will receive a single dose of azacitidine 75mg/m2 SC/IV on d 1 to 7, followed by lenalidomide 50mg PO daily on d 8 to 28 of a 42-day cycle.~Azacitidine is a chemical analogue of the cytosine nucleoside used in DNA and RNA. Azacitidine is thought to induce antineoplastic activity via two mechanisms; inhibition of DNA methyltransferase at low doses, causing hypomethylation of DNA, and direct cytotoxicity in abnormal hematopoietic cells in the bone marrow through its incorporation into DNA and RNA at high doses, resulting in cell death~Lenalidomide: Lenalidomide has been used to successfully treat both inflammatory disorders and cancers. In vitro, lenalidomide has three main activities: direct anti-tumor effect, inhibition of angiogenesis, and immunomodulatory role. In vivo, lenalidomide induces tumor cell apoptosis directly and indirectly by inhibition of bone marrow stromal cell support, by anti-angiogenic and anti-osteoclastogenic effects, and by immunomodulatory"
235563|NCT01442714|O1|Outcome|Azacitidine Plus Lenalidomide|"Patients will receive a single dose of azacitidine 75mg/m2 SC/IV on d 1 to 7, followed by lenalidomide 50mg PO daily on d 8 to 28 of a 42-day cycle.~Azacitidine is a chemical analogue of the cytosine nucleoside used in DNA and RNA. Azacitidine is thought to induce antineoplastic activity via two mechanisms; inhibition of DNA methyltransferase at low doses, causing hypomethylation of DNA, and direct cytotoxicity in abnormal hematopoietic cells in the bone marrow through its incorporation into DNA and RNA at high doses, resulting in cell death~Lenalidomide: Lenalidomide has been used to successfully treat both inflammatory disorders and cancers. In vitro, lenalidomide has three main activities: direct anti-tumor effect, inhibition of angiogenesis, and immunomodulatory role. In vivo, lenalidomide induces tumor cell apoptosis directly and indirectly by inhibition of bone marrow stromal cell support, by anti-angiogenic and anti-osteoclastogenic effects, and by immunomodulatory"
235786|NCT01441765|P1|Participant Flow|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
235564|NCT01442714|O1|Outcome|Azacitidine Plus Lenalidomide|"Patients will receive a single dose of azacitidine 75mg/m2 SC/IV on d 1-7, followed by lenalidomide 50mg PO daily on d 8-28 of a 42-day cycle.~Azacitidine is a chemical analogue of the cytosine nucleoside used in DNA and RNA. Azacitidine is thought to induce antineoplastic activity via two mechanisms; inhibition of DNA methyltransferase at low doses, causing hypomethylation of DNA, and direct cytotoxicity in abnormal hematopoietic cells in the bone marrow through its incorporation into DNA and RNA at high doses, resulting in cell death. Lenalidomide: Lenalidomide has been used to successfully treat both inflammatory disorders and cancers. In vitro, lenalidomide has three main activities: direct anti-tumor effect, inhibition of angiogenesis, and immunomodulatory role. In vivo, lenalidomide induces tumor cell apoptosis directly and indirectly by inhibition of bone marrow stromal cell support, by anti-angiogenic and anti-osteoclastogenic effects, and by immunomodulatory."
235565|NCT01442714|O1|Outcome|Azacitidine Plus Lenalidomide|Acute myeloid leukemia (AML) ORR was defined as the sum of Complete Response (CR) + CR with incomplete count recovery (CRi) + Partial Response (PR): (CR + CRi + PR)
235566|NCT01442714|E1|Reported Event|Azacitidine Plus Lenalidomide|"Patients will receive a single dose of azacitidine 75mg/m2 SC/IV on d 1 to 7, followed by lenalidomide 50mg PO daily on d 8 to 28 of a 42-day cycle.~Azacitidine is a chemical analogue of the cytosine nucleoside used in DNA and RNA. Azacitidine is thought to induce antineoplastic activity via two mechanisms; inhibition of DNA methyltransferase at low doses, causing hypomethylation of DNA, and direct cytotoxicity in abnormal hematopoietic cells in the bone marrow through its incorporation into DNA and RNA at high doses, resulting in cell death~Lenalidomide: Lenalidomide has been used to successfully treat both inflammatory disorders and cancers. In vitro, lenalidomide has three main activities: direct anti-tumor effect, inhibition of angiogenesis, and immunomodulatory role. In vivo, lenalidomide induces tumor cell apoptosis directly and indirectly by inhibition of bone marrow stromal cell support, by anti-angiogenic and anti-osteoclastogenic effects, and by immunomodulatory."
235567|NCT01442688|B3|Baseline|Total|Total of all reporting groups
235568|NCT01442688|B2|Baseline|Amoxicillin + MMX Mesalazine/Mesalamine First|MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for first intervention. Then, MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for second intervention.
235569|NCT01442688|B1|Baseline|Amoxicillin + MMX Placebo First|MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for first intervention. Then, MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for second intervention.
235570|NCT01442688|P2|Participant Flow|Amoxicillin + MMX Mesalazine/Mesalamine First|MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for first intervention. Then, MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for second intervention.
235571|NCT01442688|P1|Participant Flow|Amoxicillin + MMX Placebo First|MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for first intervention. Then, MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for second intervention.
235572|NCT01442688|O2|Outcome|Amoxicillin + MMX Mesalazine/Mesalamine|MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4.
235573|NCT01442688|O1|Outcome|Amoxicillin + MMX Placebo|MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4.
235574|NCT01442688|O2|Outcome|Amoxicillin + MMX Mesalazine/Mesalamine|MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4.
235575|NCT01442688|O1|Outcome|Amoxicillin + MMX Placebo|MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4.
235576|NCT01442688|E2|Reported Event|Amoxicillin + MMX Mesalazine/Mesalamine|MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4.
235577|NCT01442688|E1|Reported Event|Amoxicillin + MMX Placebo|MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4.
235578|NCT01442675|B1|Baseline|Menactra® Vaccine Group|Participants <56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra in this study.
235579|NCT01442675|P1|Participant Flow|Menactra® Vaccine Group|Participants <56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine in this study.
235580|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
235581|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
235582|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
235583|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
235584|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
235585|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
235586|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra in this study.
235587|NCT01442675|E1|Reported Event|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age >= 11 years received a single dose of Menactra vaccine
235589|NCT01442493|B2|Baseline|Methadone Treatment as Usual|"Methadone treatment provided as usual in the U.S.~Methadone Treatment as usual: Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic."
235590|NCT01442493|B1|Baseline|Patient-Centered Methadone Treatment|"Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.~Patient-Centered Methadone Treatment: Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event."
235591|NCT01442493|P2|Participant Flow|Methadone Treatment as Usual|"Methadone treatment provided as usual in the U.S.~Methadone Treatment as usual: Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic."
235592|NCT01442493|P1|Participant Flow|Patient-Centered Methadone Treatment|"Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.~Patient-Centered Methadone Treatment: Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event."
235593|NCT01442493|O2|Outcome|Methadone Treatment as Usual|"Methadone treatment provided as usual in the U.S.~Methadone Treatment as usual: Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic."
235594|NCT01442493|O1|Outcome|Patient-Centered Methadone Treatment|"Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.~Patient-Centered Methadone Treatment: Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event."
235595|NCT01442493|O2|Outcome|Methadone Treatment as Usual|"Methadone treatment provided as usual in the U.S.~Methadone Treatment as usual: Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic."
235596|NCT01442493|O1|Outcome|Patient-Centered Methadone Treatment|"Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.~Patient-Centered Methadone Treatment: Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event."
235597|NCT01442493|O2|Outcome|Methadone Treatment as Usual|"Methadone treatment provided as usual in the U.S.~Methadone Treatment as usual: Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic."
235598|NCT01442493|O1|Outcome|Patient-Centered Methadone Treatment|"Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.~Patient-Centered Methadone Treatment: Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event."
235599|NCT01442493|O2|Outcome|Methadone Treatment as Usual|"Methadone treatment provided as usual in the U.S.~Methadone Treatment as usual: Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic."
235600|NCT01442493|O1|Outcome|Patient-Centered Methadone Treatment|"Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.~Patient-Centered Methadone Treatment: Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event."
235601|NCT01442493|O2|Outcome|Methadone Treatment as Usual|"Methadone treatment provided as usual in the U.S.~Methadone Treatment as usual: Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic."
235602|NCT01442493|O1|Outcome|Patient-Centered Methadone Treatment|"Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.~Patient-Centered Methadone Treatment: Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event."
235603|NCT01442493|O2|Outcome|Methadone Treatment as Usual|"Methadone treatment provided as usual in the U.S.~Methadone Treatment as usual: Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic."
235604|NCT01442493|O1|Outcome|Patient-Centered Methadone Treatment|"Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.~Patient-Centered Methadone Treatment: Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event."
235605|NCT01442493|O2|Outcome|Methadone Treatment as Usual|"Methadone treatment provided as usual in the U.S.~Methadone Treatment as usual: Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic."
235606|NCT01442493|O1|Outcome|Patient-Centered Methadone Treatment|"Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.~Patient-Centered Methadone Treatment: Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event."
235607|NCT01442493|E2|Reported Event|Methadone Treatment as Usual|"Methadone treatment provided as usual in the U.S.~Methadone Treatment as usual: Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic."
235608|NCT01442493|E1|Reported Event|Patient-Centered Methadone Treatment|"Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.~Patient-Centered Methadone Treatment: Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event."
235609|NCT01442376|B4|Baseline|Total|Total of all reporting groups
235610|NCT01442376|B3|Baseline|Ondansetron|"Ondansetron and placebo to Palonosetron~Drug:~Comparator: Ondansetron~Ondansetron: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg~Placebo to Palonosetron"
235611|NCT01442376|B2|Baseline|Palonosetron 20 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg~Placebo to Ondansetron"
235612|NCT01442376|B1|Baseline|Palonosetron 10 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg~Placebo to Ondansetron"
235613|NCT01442376|P3|Participant Flow|Ondansetron|"Ondansetron and placebo to Palonosetron~Drug:~Comparator: Ondansetron~Ondansetron: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg~Placebo to Palonosetron"
235614|NCT01442376|P2|Participant Flow|Palonosetron 20 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg~Placebo to Ondansetron"
235615|NCT01442376|P1|Participant Flow|Palonosetron 10 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg~Placebo to Ondansetron"
235616|NCT01442376|O3|Outcome|Ondansetron|"Ondansetron and placebo to Palonosetron~Drug:~Comparator: Ondansetron~Ondansetron: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg~Placebo to Palonosetron"
235617|NCT01442376|O2|Outcome|Palonosetron 20 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg~Placebo to Ondansetron"
235618|NCT01442376|O1|Outcome|Palonosetron 10 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg~Placebo to Ondansetron"
235619|NCT01442376|O3|Outcome|Ondansetron|"Ondansetron and placebo to Palonosetron~Drug:~Comparator: Ondansetron~Ondansetron: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg~Placebo to Palonosetron"
235620|NCT01442376|O2|Outcome|Palonosetron 20 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg~Placebo to Ondansetron"
235621|NCT01442376|O1|Outcome|Palonosetron 10 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg~Placebo to Ondansetron"
235622|NCT01442376|E3|Reported Event|Ondansetron|"Ondansetron and placebo to Palonosetron~Drug:~Comparator: Ondansetron~Ondansetron: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg~Placebo to Palonosetron"
235623|NCT01442376|E2|Reported Event|Palonosetron 20 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg~Placebo to Ondansetron"
235624|NCT01442376|E1|Reported Event|Palonosetron 10 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg~Placebo to Ondansetron"
235625|NCT01442181|B3|Baseline|Total|Total of all reporting groups
235626|NCT01442181|B2|Baseline|Medical Therapy|Patients are treated with rhythm and rate control medications.
235627|NCT01442181|B1|Baseline|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
235628|NCT01442181|P2|Participant Flow|Medical Therapy|Patients are treated with rhythm and rate control medications.
235629|NCT01442181|P1|Participant Flow|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
235630|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications.
235631|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
235632|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications.
235633|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
235634|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications.
235635|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
235636|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications.
235637|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
235641|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
235642|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications
235643|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
235644|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications
235645|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
235646|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications
235647|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
235648|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications
235649|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
235650|NCT01442181|E2|Reported Event|Medical Therapy|Patients are treated with rhythm and rate control medications.
235651|NCT01442181|E1|Reported Event|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
235652|NCT01442155|B1|Baseline|Capecitabine + Oxaliplatin|"Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.~Capecitabine: Administered according to the Summary of Product Characteristics.~Oxaliplatin: Administered according to the Summary of Product Characteristics."
235653|NCT01442155|P1|Participant Flow|Capecitabine + Oxaliplatin|"Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.~Capecitabine: Administered according to the Summary of Product Characteristics.~Oxaliplatin: Administered according to the Summary of Product Characteristics."
235654|NCT01442155|O1|Outcome|Capecitabine + Oxaliplatin|"Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.~Capecitabine: Administered according to the Summary of Product Characteristics.~Oxaliplatin: Administered according to the Summary of Product Characteristics."
235655|NCT01442155|O1|Outcome|Capecitabine + Oxaliplatin|"Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.~Capecitabine: Administered according to the Summary of Product Characteristics.~Oxaliplatin: Administered according to the Summary of Product Characteristics."
235656|NCT01442155|E1|Reported Event|Capecitabine + Oxaliplatin|"Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.~Capecitabine: Administered according to the Summary of Product Characteristics.~Oxaliplatin: Administered according to the Summary of Product Characteristics."
235657|NCT01442129|B3|Baseline|Total|Total of all reporting groups
235658|NCT01442129|B2|Baseline|Control Solution|"Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO~50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO: Injection of control solution during the LVAD implantation."
235659|NCT01442129|B1|Baseline|MPC Intramyocardial Injection|"Intramyocardial injections of 25 million MPCs~Mesenchymal Precursor Cell Injection: Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation"
235660|NCT01442129|P2|Participant Flow|Control Solution|"Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO~50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO: Injection of control solution during the LVAD implantation."
235661|NCT01442129|P1|Participant Flow|MPC Intramyocardial Injection|"Intramyocardial injections of 25 million MPCs~Mesenchymal Precursor Cell Injection: Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation"
235662|NCT01442129|O2|Outcome|Control Solution|"Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO~50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO: Injection of control solution during the LVAD implantation."
235663|NCT01442129|O1|Outcome|MPC Intramyocardial Injection|"Intramyocardial injections of 25 million MPCs~Mesenchymal Precursor Cell Injection: Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation"
235664|NCT01442129|O2|Outcome|Control Solution|"Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO~50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO: Injection of control solution during the LVAD implantation."
235665|NCT01442129|O1|Outcome|MPC Intramyocardial Injection|"Intramyocardial injections of 25 million MPCs~Mesenchymal Precursor Cell Injection: Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation"
235666|NCT01442129|E2|Reported Event|Control Solution|"Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO~50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO: Injection of control solution during the LVAD implantation."
235667|NCT01442129|E1|Reported Event|MPC Intramyocardial Injection|"Intramyocardial injections of 25 million MPCs~Mesenchymal Precursor Cell Injection: Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation"
235668|NCT01442103|B1|Baseline|Silver Gel, Chronic Wounds|Open, non-comparative, single-centre investigation exploring the clinical utility of a new silver gel for use on chronic wounds.
235669|NCT01442103|P1|Participant Flow|Silver Gel, Chronic Wounds|The patients will present with chronic wounds in need of initial treatment prior to initiating standard of care (i.e. wound bed with eschar or slough), in need of treatment after debridement or with presenting inflammation along with need for treatment.Only one wound will be chosen for treatment in the study and the area should not exceed 10x10 cm and not be deeper than 6 cm. Photos of the wound will be taken at each visit.
235670|NCT01442103|O1|Outcome|Device Common Dressing|Normlgel® Ag is an opaque, amorphous hyrdrogel containing a high (>80%) water content and water soluble polymer chains.
238694|NCT01433263|E3|Reported Event|Follow-up - 30mg/kg BYM338|Follow-up - 30mg/kg BYM338
235671|NCT01442103|E1|Reported Event|Device Common Dressing|Normal Ag is an opaque, amorphous hydrogel containing a high watersoluble polymer chains and an antimicrobial silver compund
235672|NCT01442064|B7|Baseline|Total|Total of all reporting groups
235673|NCT01442064|B6|Baseline|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
235674|NCT01442064|B5|Baseline|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
235675|NCT01442064|B4|Baseline|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
235676|NCT01442064|B3|Baseline|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
235677|NCT01442064|B2|Baseline|Ranibizumab (0.3 mg BRAVO)|In this extension study participant received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
235678|NCT01442064|B1|Baseline|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
235679|NCT01442064|P6|Participant Flow|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
235680|NCT01442064|P5|Participant Flow|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
235681|NCT01442064|P4|Participant Flow|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
235682|NCT01442064|P3|Participant Flow|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
235683|NCT01442064|P2|Participant Flow|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
235684|NCT01442064|P1|Participant Flow|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
235685|NCT01442064|O6|Outcome|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received 0.5 mg Ranibuzumab intravitreal injections in the 6 month treatment period of CRUISE.
235686|NCT01442064|O5|Outcome|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
235687|NCT01442064|O4|Outcome|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year)for 24 months. Participants in this group received sham intravitreal injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
235688|NCT01442064|O3|Outcome|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
235689|NCT01442064|O2|Outcome|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
235817|NCT01441596|E1|Reported Event|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
235818|NCT01441570|B3|Baseline|Total|Total of all reporting groups
235690|NCT01442064|O1|Outcome|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
235691|NCT01442064|O6|Outcome|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibuzumab intravitreal injections in the 6 month treatment period of CRUISE.
235692|NCT01442064|O5|Outcome|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
235693|NCT01442064|O4|Outcome|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received sham intravitreal injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
235694|NCT01442064|O3|Outcome|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
235695|NCT01442064|O2|Outcome|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
235696|NCT01442064|O1|Outcome|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
235697|NCT01442064|O6|Outcome|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibuzumab intravitreal injections in the 6 month treatment period of CRUISE.
235698|NCT01442064|O5|Outcome|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
235699|NCT01442064|O4|Outcome|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received sham intravitreal injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
235700|NCT01442064|O3|Outcome|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
235701|NCT01442064|O2|Outcome|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
235702|NCT01442064|O1|Outcome|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
235703|NCT01442064|O6|Outcome|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibuzumab intravitreal injections in the 6 month treatment period of CRUISE.
235704|NCT01442064|O5|Outcome|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
235705|NCT01442064|O4|Outcome|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received sham intravitreal injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
235706|NCT01442064|O3|Outcome|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
235707|NCT01442064|O2|Outcome|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
235819|NCT01441570|B2|Baseline|Metoprolol Succinate|Metoprolol succinate: Subject will take metoprolol succinate daily for 12 weeks.
235708|NCT01442064|O1|Outcome|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
235709|NCT01442064|O6|Outcome|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibuzumab intravitreal injections in the 6 month treatment period of CRUISE.
235710|NCT01442064|O5|Outcome|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
235711|NCT01442064|O4|Outcome|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received sham intravitreal injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
235712|NCT01442064|O3|Outcome|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
235713|NCT01442064|O2|Outcome|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
235714|NCT01442064|O1|Outcome|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
235715|NCT01442064|E3|Reported Event|Ranibizumab (0.5 mg)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO or the 6 month treatment period of CRUISE.
235716|NCT01442064|E2|Reported Event|Ranibizumab (0.3 mg)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO or the 6 month treatment period of CRUISE.
235717|NCT01442064|E1|Reported Event|Ranibizumab (Sham)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO or the 6 month treatment period of CRUISE and received Ranibizumab during the 6 month observation period of the initial study or this extension study.
235718|NCT01442038|B3|Baseline|Total|Total of all reporting groups
235719|NCT01442038|B2|Baseline|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
235720|NCT01442038|B1|Baseline|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
235721|NCT01442038|P2|Participant Flow|Placebo|Ranolazine placebo (1 tablet) for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
235722|NCT01442038|P1|Participant Flow|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
235723|NCT01442038|O2|Outcome|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
235724|NCT01442038|O1|Outcome|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
235725|NCT01442038|O2|Outcome|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
235726|NCT01442038|O1|Outcome|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
235727|NCT01442038|O2|Outcome|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
235820|NCT01441570|B1|Baseline|Nebivolol|Nebivolol: Subject will take nebivolol daily for 12 weeks.
235728|NCT01442038|O1|Outcome|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
235729|NCT01442038|O2|Outcome|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
235730|NCT01442038|O1|Outcome|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
235731|NCT01442038|E2|Reported Event|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
235732|NCT01442038|E1|Reported Event|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
235733|NCT01441973|B3|Baseline|Total|Total of all reporting groups
235734|NCT01441973|B2|Baseline|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
235735|NCT01441973|B1|Baseline|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
235736|NCT01441973|P2|Participant Flow|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
235737|NCT01441973|P1|Participant Flow|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
235738|NCT01441973|O3|Outcome|Elotuzumab, All Dosages|All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms
235739|NCT01441973|O2|Outcome|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
235740|NCT01441973|O1|Outcome|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
235741|NCT01441973|O3|Outcome|Elotuzumab, All Dosages|All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms
235742|NCT01441973|O2|Outcome|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
235743|NCT01441973|O1|Outcome|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
235744|NCT01441973|O3|Outcome|Elotuzumab, All Dosages|All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms
235745|NCT01441973|O2|Outcome|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
235746|NCT01441973|O1|Outcome|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
235747|NCT01441973|O3|Outcome|Elotuzumab, All Dosages|All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms
235748|NCT01441973|O2|Outcome|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
235749|NCT01441973|O1|Outcome|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
235750|NCT01441973|O3|Outcome|Elotuzumab, All Dosages|All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms
235751|NCT01441973|O2|Outcome|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
235752|NCT01441973|O1|Outcome|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
235753|NCT01441973|O3|Outcome|Elotuzumab, All Dosages|All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms
235754|NCT01441973|O2|Outcome|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
235755|NCT01441973|O1|Outcome|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
235756|NCT01441973|E2|Reported Event|Elotuzumab(E) : 20 mg/kg/Dose|
235757|NCT01441973|E1|Reported Event|Elotuzumab(E) : 10 mg/kg/Dose|
235758|NCT01441960|B1|Baseline|Succinylcholine and Rocuronium|All study participants
235821|NCT01441570|P2|Participant Flow|Metoprolol Succinate|Metoprolol succinate: Subject will take metoprolol succinate daily for 12 weeks.
238695|NCT01433263|E2|Reported Event|Core - Placebo|Core - Placebo
235759|NCT01441960|P2|Participant Flow|Rocuronium First , Then Succinylcholine|"After induction of anesthesia Rocuronium (Zemuron®, Oganon USA Inc) 0.4 mg/kg (1.33 × ED95) mg/kg was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline. After the ECT treatment and when appropriate, as determined by the practicing anesthesiologist, the rocuronium-induced neuromuscular blockade was reversed with neostigmine 50 microgram/kg, administered with glycopyrrolate 10 microgram/kg.~By identifying the optimal (minimal effective) dose of rocuronium, in the subsequent treatment of the subject, Succinylcholine (Quelicin®, Hospira Inc., Lake Forest, IL) 0.8 (2.67 × ED95) mg/kg was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline."
235760|NCT01441960|P1|Participant Flow|Succinylcholine First, Then Rocuronium|"After induction of anesthesia Succinylcholine (Quelicin®, Hospira Inc., Lake Forest, IL) 0.8 (2.67 × ED95) mg/kg was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline.~By identifying the optimal (minimal effective) dose of succinylcholine, Rocuronium bromide (Zemuron®, Oganon USA Inc) 0.4 mg/kg (1.33 × ED95) was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline. After the ECT treatment and when appropriate, as determined by the practicing anesthesiologist, the induced neuromuscular blockade was reversed with neostigmine 50 microgram/kg, administered with glycopyrrolate 10 microgram/kg."
235761|NCT01441960|O2|Outcome|Rocuronium|Duration of induced seizure
235762|NCT01441960|O1|Outcome|Succinylcholine|Duration of induced seizure after standard ECT
235763|NCT01441960|O2|Outcome|Rocuronium|Time to recovery after single bolus administered at the beginning of ECT therapy
235764|NCT01441960|O1|Outcome|Succinylchline|Time to recovery after single bolus administered at the beginning of ECT therapy
235765|NCT01441960|O2|Outcome|NMBA- Rocuronium|Cross-over randomized controlled, assessor blinded clinical trial. Rocuronium: Rocuronium will be given during the series of ECT treatments. The initial dose will be defined by the anesthesiologist in charge for clinical care. The Dixon's up and down method will be used in consecutive treatments.
235766|NCT01441960|O1|Outcome|NMBA: Sux|"Cross-over randomized controlled, assessor blinded clinical trial.~Succinylcholine: Succinylcholine will be given during the series of ECT treatments. The initial dose will be defined by the anesthesiologist in charge for clinical care. The Dixon's up and down method will be used in consecutive treatments. The investigators will switch to the second compound as soon as the patient has received one neuromuscular blocking agent dose that resulted in 'acceptable muscle relaxation', and another dose that resulted in 'unacceptable' conditions'."
235767|NCT01441960|E2|Reported Event|NMBA: Rocuronium|No adverse events occurred during the study
235768|NCT01441960|E1|Reported Event|NMBA: Succinylcholine|No adverse events occurred during the study
235769|NCT01441882|B1|Baseline|Treatment (Dasatinib)|"Patients receive dasatinib PO QD during course 1 and if tolerated, BID in subsequent courses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Dasatinib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
235770|NCT01441882|P1|Participant Flow|Treatment (Dasatinib)|"Patients receive dasatinib PO QD during course 1 and if tolerated, BID in subsequent courses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Dasatinib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
235771|NCT01441882|O1|Outcome|Treatment (Dasatinib)|"Patients receive dasatinib PO QD during course 1 and if tolerated, BID in subsequent courses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Dasatinib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
235772|NCT01441882|E1|Reported Event|Treatment (Dasatinib)|"Patients receive dasatinib PO QD during course 1 and if tolerated, BID in subsequent courses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Dasatinib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
235773|NCT01441843|B3|Baseline|Total|Total of all reporting groups
235774|NCT01441843|B2|Baseline|NaCl 0.9%|"NaCl 0.9% 4ml~NaCl 0.9% (Sodium Chloride) : Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery"
235775|NCT01441843|B1|Baseline|Lorazepam|"Lorazepam 4mg/4ml~Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery"
235776|NCT01441843|P2|Participant Flow|NaCl 0.9%|"NaCl 0.9% 4ml~NaCl 0.9% (Sodium Chloride) : Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery"
235777|NCT01441843|P1|Participant Flow|Lorazepam|"Lorazepam 4mg/4ml~Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery"
235778|NCT01441843|O2|Outcome|NaCl 0.9%|"NaCl 0.9% 4ml~NaCl 0.9% (Sodium Chloride) : Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery"
235779|NCT01441843|O1|Outcome|Lorazepam|"Lorazepam 4mg/4ml~Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery"
235780|NCT01441843|E2|Reported Event|NaCl 0.9%|"NaCl 0.9% 4ml~NaCl 0.9% (Sodium Chloride) : Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery"
235781|NCT01441843|E1|Reported Event|Lorazepam|"Lorazepam 4mg/4ml~Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery"
235782|NCT01441765|B3|Baseline|Total|Total of all reporting groups
235783|NCT01441765|B2|Baseline|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
235784|NCT01441765|B1|Baseline|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
235785|NCT01441765|P2|Participant Flow|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
235908|NCT01441401|O2|Outcome|Long Term|Participants who received gabapentin for 1 year or more
235787|NCT01441765|O2|Outcome|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
235788|NCT01441765|O1|Outcome|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
235789|NCT01441765|O2|Outcome|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
235790|NCT01441765|O1|Outcome|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
235791|NCT01441765|O2|Outcome|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
235792|NCT01441765|O1|Outcome|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
235793|NCT01441765|O2|Outcome|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
235794|NCT01441765|O1|Outcome|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
235795|NCT01441765|O2|Outcome|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
235796|NCT01441765|O1|Outcome|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
235797|NCT01441765|E2|Reported Event|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
235798|NCT01441765|E1|Reported Event|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
235799|NCT01441596|B4|Baseline|Total|Total of all reporting groups
235800|NCT01441596|B3|Baseline|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
235801|NCT01441596|B2|Baseline|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
235802|NCT01441596|B1|Baseline|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
235803|NCT01441596|P3|Participant Flow|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
235804|NCT01441596|P2|Participant Flow|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
235805|NCT01441596|P1|Participant Flow|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
235806|NCT01441596|O3|Outcome|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
235807|NCT01441596|O2|Outcome|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
235808|NCT01441596|O1|Outcome|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
235809|NCT01441596|O3|Outcome|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
235810|NCT01441596|O2|Outcome|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
235811|NCT01441596|O1|Outcome|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
235812|NCT01441596|O3|Outcome|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
235813|NCT01441596|O2|Outcome|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
235814|NCT01441596|O1|Outcome|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
235815|NCT01441596|E3|Reported Event|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
235816|NCT01441596|E2|Reported Event|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
235822|NCT01441570|P1|Participant Flow|Nebivolol|Nebivolol: Subject will take nebivolol daily for 12 weeks.
235823|NCT01441570|O2|Outcome|Metoprolol|Metoprolol succinate: Subject will take metoprolol succinate daily for 12 weeks.
235824|NCT01441570|O1|Outcome|Nebivolol|Nebivolol: Subject will take nebivolol daily for 12 weeks.
235825|NCT01441570|O2|Outcome|Metoprolol|Metoprolol succinate: Subject will take metoprolol succinate daily for 12 weeks.
235826|NCT01441570|O1|Outcome|Nebivolol|Nebivolol: Subject will take nebivolol daily for 12 weeks.
235827|NCT01441570|E2|Reported Event|Metoprolol|Metoprolol succinate: Subject will take metoprolol succinate daily for 12 weeks.
235828|NCT01441570|E1|Reported Event|Nebivolol|Nebivolol: Subject will take nebivolol daily for 12 weeks.
235829|NCT01441466|B3|Baseline|Total|Total of all reporting groups
235830|NCT01441466|B2|Baseline|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
235831|NCT01441466|B1|Baseline|Group Without Isolation|Patients in this arm are nursed together (in the same room) independent of viral agent.
235832|NCT01441466|P2|Participant Flow|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
235833|NCT01441466|P1|Participant Flow|Group Without Isolation|Patients in this arm are nursed together (in the same room) independent of viral agent.
235834|NCT01441466|O2|Outcome|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
235835|NCT01441466|O1|Outcome|Group Without Isolation|"Patients in this arm are nursed together (in the same room) independent of viral agent.~Isolation: Patients in this arm are nursed together (in the same room) independent of viral agent"
235836|NCT01441466|O2|Outcome|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
235837|NCT01441466|O1|Outcome|Group Without Isolation|"Patients in this arm are nursed together (in the same room) independent of viral agent.~Isolation: Patients in this arm are nursed together (in the same room) independent of viral agent"
235838|NCT01441466|O2|Outcome|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
235839|NCT01441466|O1|Outcome|Group Without Isolation|"Patients in this arm are nursed together (in the same room) independent of viral agent.~Isolation: Patients in this arm are nursed together (in the same room) independent of viral agent"
235840|NCT01441466|O2|Outcome|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
235841|NCT01441466|O1|Outcome|Group Without Isolation|"Patients in this arm are nursed together (in the same room) independent of viral agent.~Isolation: Patients in this arm are nursed together (in the same room) independent of viral agent"
235842|NCT01441466|O2|Outcome|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
235843|NCT01441466|O1|Outcome|Group Without Isolation|"Patients in this arm are nursed together (in the same room) independent of viral agent.~Isolation: Patients in this arm are nursed together (in the same room) independent of viral agent"
235844|NCT01441466|O2|Outcome|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
235845|NCT01441466|O1|Outcome|Group Without Isolation|Patients in this arm are nursed together (in the same room) independent of viral agent.
235846|NCT01441466|E2|Reported Event|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
235847|NCT01441466|E1|Reported Event|Group Without Isolation|Patients in this arm are nursed together (in the same room) independent of viral agent.
235848|NCT01441440|B4|Baseline|Total|Total of all reporting groups
235849|NCT01441440|B3|Baseline|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
235850|NCT01441440|B2|Baseline|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
235851|NCT01441440|B1|Baseline|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
235852|NCT01441440|P3|Participant Flow|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
235909|NCT01441401|O1|Outcome|Non-Long Term|Participants who received gabapentin for less than 1 year
235853|NCT01441440|P2|Participant Flow|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
235854|NCT01441440|P1|Participant Flow|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
235855|NCT01441440|O3|Outcome|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
235856|NCT01441440|O2|Outcome|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
235857|NCT01441440|O1|Outcome|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
235858|NCT01441440|O3|Outcome|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
235859|NCT01441440|O2|Outcome|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
235860|NCT01441440|O1|Outcome|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
235861|NCT01441440|O3|Outcome|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
235862|NCT01441440|O2|Outcome|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
235863|NCT01441440|O1|Outcome|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
235864|NCT01441440|O3|Outcome|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
235865|NCT01441440|O2|Outcome|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
235866|NCT01441440|O1|Outcome|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
235867|NCT01441440|O3|Outcome|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
235868|NCT01441440|O2|Outcome|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
235869|NCT01441440|O1|Outcome|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
235870|NCT01441440|O3|Outcome|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
235871|NCT01441440|O2|Outcome|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
235872|NCT01441440|O1|Outcome|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
235873|NCT01441440|E3|Reported Event|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
263459|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
235874|NCT01441440|E2|Reported Event|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
235875|NCT01441440|E1|Reported Event|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
235876|NCT01441414|B1|Baseline|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
235877|NCT01441414|P1|Participant Flow|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
235878|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
235879|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
235880|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
235881|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
235882|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
235883|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
235884|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
235885|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
235886|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
235887|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
235888|NCT01441414|O4|Outcome|All-causality CTCAE Grade 5|Number of participants who had serious TEAEs (all-causality) of CTCAE Grade 5 TEAEs are presented
235889|NCT01441414|O3|Outcome|All-causality CTCAE Grade 4|Number of participants who had serious TEAEs (all-causality) of CTCAE Grade 4 TEAEs are presented
235890|NCT01441414|O2|Outcome|All-causality CTCAE Grade 3|Number of participants who had serious TEAEs (all-causality) of CTCAE Grade 3 TEAEs are presented
235891|NCT01441414|O1|Outcome|All-causality CTCAE Grade 2|Number of participants who had serious TEAEs (all-causality) of CTCAE Grade 2 TEAEs are presented
235892|NCT01441414|O8|Outcome|Treatment-related Overall|Incidence and severity of treatment-related CTCAE Grades 3,4, and 5 are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
235893|NCT01441414|O7|Outcome|All-causality Overall|Incidence and severity of all-causality CTCAE Grades 3, 4, and 5 are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
235894|NCT01441414|O6|Outcome|Treatment-related CTCAE Grade 5|Incidence and severity of treatment-related CTCAE Grade 5 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
235895|NCT01441414|O5|Outcome|Treatment-related CTCAE Grade 4|Incidence and severity of treatment-related CTCAE Grade 4 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
235896|NCT01441414|O4|Outcome|Treatment-related CTCAE Grade 3|Incidence and severity of treatment-related CTCAE Grade 3 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
235897|NCT01441414|O3|Outcome|All-causality CTCAE Grade 5|Incidence and severity of all-causality CTCAE Grade 5 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
235898|NCT01441414|O2|Outcome|All-causality CTCAE Grade 4|Incidence and severity of all-causality CTCAE Grade 4 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
235899|NCT01441414|O1|Outcome|All-causality CTCAE Grade 3|Incidence and severity of all-causality CTCAE Grade 3 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
235900|NCT01441414|E1|Reported Event|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
235901|NCT01441401|B1|Baseline|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
235902|NCT01441401|P1|Participant Flow|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
235903|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
235904|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
235905|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
235906|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
235907|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
235910|NCT01441401|O5|Outcome|Four or More Concomitant Antiepileptic Drugs|Participants taking four or more concomitant antiepileptic drugs at baseline
235911|NCT01441401|O4|Outcome|Three Concomitant Antiepileptic Drugs|Participants taking three concomitant antiepileptic drugs at baseline
235912|NCT01441401|O3|Outcome|Two Concomitant Antiepileptic Drugs|Participants taking two concomitant antiepileptic drugs at baseline
235913|NCT01441401|O2|Outcome|One Concomitant Antiepileptic Drug|Participants taking one concomitant antiepileptic drug at baseline
235914|NCT01441401|O1|Outcome|No Concomitant Antiepileptic Drug|Participants taking no concomitant antiepileptic drug at baseline
235915|NCT01441401|O3|Outcome|Unknown|Participants with unknown frequency of baseline epileptic seizure
235916|NCT01441401|O2|Outcome|>8 Episodes|Participants with baseline episodes of epileptic seizure more than 8
235917|NCT01441401|O1|Outcome|<=8 Episodes|Participants with baseline episodes of epileptic seizure 8 or less
235918|NCT01441401|O4|Outcome|Unknown|Participants with unknown severity of baseline epileptic seizure
235919|NCT01441401|O3|Outcome|Severe|Participants with severe epileptic seizure at baseline
235920|NCT01441401|O2|Outcome|Moderate|Participants with moderate epileptic seizure at baseline
235921|NCT01441401|O1|Outcome|Mild|Participants with mild epileptic seizure at baseline
235922|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
235923|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
235924|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
235925|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
235926|NCT01441401|E1|Reported Event|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
235927|NCT01441245|B3|Baseline|Total|Total of all reporting groups
235928|NCT01441245|B2|Baseline|iIV Group|The group that received the intermittent infusion of furosemide (iIV), consisted of 27 patients.
235929|NCT01441245|B1|Baseline|cIV Group|The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients.
235930|NCT01441245|P2|Participant Flow|iIV Group|The second group that received the same drug in bolus injections twice a day (iIV), consisted of 27 patients.
235931|NCT01441245|P1|Participant Flow|cIV Group|The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients.
235932|NCT01441245|O2|Outcome|Dopamine Infusion in iIV|Prevalence of dopamine infusion in intermittent intravenous furosemide infusion.
235933|NCT01441245|O1|Outcome|Dopamine Infusion in cIV|Prevalence of dopamine infusion in continuous intravenous furosemide infusion.
235934|NCT01441245|O2|Outcome|GFR at Discharge in iIV|Mean GFR at discharge in intermittent intravenous fursoemide infusion.
235935|NCT01441245|O1|Outcome|GFR at Discharge in cIV|Mean GFR at discharge in continuous intravenous fursoemide infusion.
263460|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
235936|NCT01441245|O2|Outcome|GFR Change in iIV|Mean GFR change in intermittent intravenous fursoemide infusion.
235937|NCT01441245|O1|Outcome|GFR Change in cIV|Mean GFR change in continuous intravenous fursoemide infusion.
235938|NCT01441245|O2|Outcome|BNP Change in iIV|Evaluation of BNP change in Intermittent intravenous furosemide infusion group
235939|NCT01441245|O1|Outcome|BNP Change in cIV|Evaluation of BNP change in Intermittent intravenous furosemide infusion group
235940|NCT01441245|O2|Outcome|BNP Levels at Discharge in iIV Group|"The group that received the bolus infusion of furosemide (iIV), consisted of 27 patients~furosemide infusion: Patients were randomized in a 1:1 ratio to receive furosemide dose divided into twice-daily bolus injection (group 0) or continuous infusion (group 1)(mixed as a 1:1 ratio in 5% dextrose in water) for a time period ranging from 72 to 120 hours. The mean daily diuretic dosage was similar in the two groups. The median time from presentation to randomization was 16 hours, and the median duration of study-drug administration was 112± 24 hours"
235941|NCT01441245|O1|Outcome|BNP Levels at Discharge in cIV Group|"The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients~furosemide infusion: Patients were randomized in a 1:1 ratio to receive furosemide dose divided into twice-daily bolus injection (group 0) or continuous infusion (group 1)(mixed as a 1:1 ratio in 5% dextrose in water) for a time period ranging from 72 to 120 hours. The mean daily diuretic dosage was similar in the two groups. The median time from presentation to randomization was 16 hours, and the median duration of study-drug administration was 112± 24 hours"
235942|NCT01441245|O2|Outcome|Changes in Creatinine in iIV Group|"The group that received the bolus infusion of furosemide (iIV), consisted of 27 patients~furosemide infusion: Patients were randomized in a 1:1 ratio to receive furosemide dose divided into twice-daily bolus injection (group 0) or continuous infusion (group 1)(mixed as a 1:1 ratio in 5% dextrose in water) for a time period ranging from 72 to 120 hours. The mean daily diuretic dosage was similar in the two groups. The median time from presentation to randomization was 16 hours, and the median duration of study-drug administration was 112± 24 hours"
235943|NCT01441245|O1|Outcome|Changes in Creatinine in cIV Group|"The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients~furosemide infusion: Patients were randomized in a 1:1 ratio to receive furosemide dose divided into twice-daily bolus injection (group 0) or continuous infusion (group 1)(mixed as a 1:1 ratio in 5% dextrose in water) for a time period ranging from 72 to 120 hours. The mean daily diuretic dosage was similar in the two groups. The median time from presentation to randomization was 16 hours, and the median duration of study-drug administration was 112± 24 hours"
235944|NCT01441245|O2|Outcome|Creatinine at Discharge in iIV|Mean creatinine at discharge in intermittent intravenous fursoemide infusion.
235945|NCT01441245|O1|Outcome|Creatinine at Discharge in cIV|Mean creatinine at discharge in continuous intravenous fursoemide infusion.
235946|NCT01441245|O2|Outcome|Lenght of Hospitalization in iIV|Prevalence of hospital stay > 10 days in intermittent intravenous furosemide infusion.
235947|NCT01441245|O1|Outcome|Lenght of Hospitalization in cIV|Prevalence of hospital stay > 10 days in continuous intravenous furosemide infusion.
235948|NCT01441245|O2|Outcome|Urine Output in iIV|Evaluation of urine output in Intermittent intravenous furosemide infusion group
235949|NCT01441245|O1|Outcome|Urine Output in cIV|Evaluation of urine output in Intermittent intravenous furosemide infusion group
235950|NCT01441245|E2|Reported Event|iIV Group|The second group that received the same drug in bolus injections twice a day (iIV), consisted of 27 patients.
235951|NCT01441245|E1|Reported Event|cIV Group|The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients.
235952|NCT01441180|B4|Baseline|Total|Total of all reporting groups
235953|NCT01441180|B3|Baseline|Phase 2 Arm B|(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
235954|NCT01441180|B2|Baseline|Phase 2 Arm A|(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
235955|NCT01441180|B1|Baseline|Phase 1|(N =10): Participants will be enrolled and will receive GS-7977 QD in combination with RBV for a total of 24 weeks. The study team will perform an interim evaluation of data and safety at the end of 12 weeks of treatment.
235956|NCT01441180|P3|Participant Flow|Phase 2 Arm B|(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
235957|NCT01441180|P2|Participant Flow|Phase 2 Arm A|(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
235958|NCT01441180|P1|Participant Flow|Phase 1|(N =10): Participants will be enrolled and will receive GS-7977 QD in combination with RBV for a total of 24 weeks. The study team will perform an interim evaluation of data and safety at the end of 12 weeks of treatment.
235959|NCT01441180|O3|Outcome|Phase 2 Arm B|"(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).~GS7977~RBV"
235960|NCT01441180|O2|Outcome|Phase 2 Arm A|"(N =25) 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)~GS7977~RBV"
235961|NCT01441180|O1|Outcome|Phase 1|"Participants (N =10) will receive GS-7977 QD in combination with RBV for a total of 24 weeks. The study team will perform an interim evaluation of data and safety at the end of 12 weeks of treatment.~GS7977~RBV"
235962|NCT01441180|O3|Outcome|Phase 2 Arm B (Sofosbuvir + Low-dose RBV)|(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
235963|NCT01441180|O2|Outcome|Phase 2 Arm A (Sofosbuvir + Weight Based RBV)|(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
235964|NCT01441180|O1|Outcome|Phase 1|
235965|NCT01441180|E3|Reported Event|Phase 2 Arm B (Sofosbuvir + Low-dose RBV)|(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
235966|NCT01441180|E2|Reported Event|Phase 2 Arm A (Sofosbuvir + Weight Based RBV)|(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
235967|NCT01441180|E1|Reported Event|Phase 1 (Sofosbuvir + Weight Based RBV)|(N =10): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
235968|NCT01441102|B1|Baseline|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
235969|NCT01441102|P1|Participant Flow|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
235970|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
235971|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
235972|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
235973|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
235974|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
235975|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
235976|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
235977|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
235978|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
235979|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
235980|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
235981|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
235982|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
235983|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
235984|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
235985|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
235986|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
235987|NCT01441102|E1|Reported Event|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
235988|NCT01441076|B1|Baseline|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
235989|NCT01441076|P1|Participant Flow|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
235990|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
235991|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
235992|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
235993|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
235994|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
235995|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
235996|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
235997|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
235998|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
235999|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
236000|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
236001|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
236002|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
236003|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
236004|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
236005|NCT01441076|E1|Reported Event|Anakinra|Treatment with Anakinra 100mg subcutaneous daily
236006|NCT01440972|B3|Baseline|Total|Total of all reporting groups
236007|NCT01440972|B2|Baseline|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
236008|NCT01440972|B1|Baseline|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
236091|NCT01440816|O1|Outcome|All Patients: Tavo-EP|All patients from Cohort A and Cohort B.
236009|NCT01440972|P2|Participant Flow|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
236010|NCT01440972|P1|Participant Flow|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
236011|NCT01440972|O2|Outcome|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
236012|NCT01440972|O1|Outcome|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
236013|NCT01440972|O2|Outcome|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
236014|NCT01440972|O1|Outcome|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
236015|NCT01440972|O2|Outcome|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
236016|NCT01440972|O1|Outcome|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
236017|NCT01440972|O2|Outcome|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
236018|NCT01440972|O1|Outcome|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
236019|NCT01440972|O2|Outcome|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
236020|NCT01440972|O1|Outcome|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
236021|NCT01440972|E2|Reported Event|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
236022|NCT01440972|E1|Reported Event|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
236023|NCT01440959|B1|Baseline|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
236024|NCT01440959|P1|Participant Flow|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
236025|NCT01440959|O1|Outcome|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
236026|NCT01440959|O1|Outcome|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
236027|NCT01440959|O1|Outcome|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
236028|NCT01440959|O1|Outcome|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
236029|NCT01440959|O1|Outcome|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
236030|NCT01440959|E1|Reported Event|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
236031|NCT01440946|B3|Baseline|Total|Total of all reporting groups
236032|NCT01440946|B2|Baseline|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236033|NCT01440946|B1|Baseline|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236034|NCT01440946|P2|Participant Flow|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236035|NCT01440946|P1|Participant Flow|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single intravenous (IV) injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last pharmacokinetic (PK) sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236036|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236037|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236092|NCT01440816|O1|Outcome|All Patients: Tavo-EP|All patients from Cohort A and Cohort B.
236116|NCT01440764|O2|Outcome|Aerosol Furosemide (80mg)|"Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes on 1 test day.~To be compared to Aerosol Saline (8ml) Arm.~Furosemide"
238696|NCT01433263|E1|Reported Event|Core - 30mg/kg BYM338|Core - 30mg/kg BYM338
236038|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236039|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236040|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236041|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236042|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236043|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236044|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236045|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236046|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236047|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236048|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236049|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236050|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236093|NCT01440816|O1|Outcome|Cohort B: Tavo-EP|Patients in Cohort B received up to 4 cycles (3 daily treatments on Days 1, 5, and 8, per cycle) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, with 12 weeks planned between each cycle, lasting up to 12 months.
236750|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
236051|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236052|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236053|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236054|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236055|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236056|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236057|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236058|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236059|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236060|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236061|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236062|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236063|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236094|NCT01440816|O2|Outcome|Cohort B: Tavo-EP|Patients in Cohort B received up to 4 cycles (3 daily treatments on Days 1, 5, and 8, per cycle) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, with 12 weeks planned between each cycle, lasting up to 12 months.
236858|NCT01438996|P3|Participant Flow|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
236064|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236065|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236066|NCT01440946|O3|Outcome|Total|All Participants
236067|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236068|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236069|NCT01440946|E2|Reported Event|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236070|NCT01440946|E1|Reported Event|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
236071|NCT01440881|B3|Baseline|Total|Total of all reporting groups
236072|NCT01440881|B2|Baseline|Placebo|"infuses at 0.01MCG/KG/min for 48 hours~Placebo: infuses at 0.01MCG/KG/min for 48 hours"
236073|NCT01440881|B1|Baseline|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours~Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
236074|NCT01440881|P2|Participant Flow|Placebo|"infuses at 0.01micrograms (MCG)/kilograms (KG)/minute (min) for 48 hours~Placebo: infuses at 0.01MCG/KG/min for 48 hours"
236075|NCT01440881|P1|Participant Flow|Nesiritide|"infuses at 0.01 micrograms (MCG)/kilograms (KG)/minute (min) for 48 hours~Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
236076|NCT01440881|O2|Outcome|Placebo|infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
236077|NCT01440881|O1|Outcome|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours~Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
236078|NCT01440881|O2|Outcome|Placebo|infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
236079|NCT01440881|O1|Outcome|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours~Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
236080|NCT01440881|O2|Outcome|Placebo|infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
236081|NCT01440881|O1|Outcome|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours~Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
236082|NCT01440881|O2|Outcome|Placebo|"infuses at 0.01MCG/KG/min for 48 hours~Placebo: infuses at 0.01MCG/KG/min for 48 hours"
236083|NCT01440881|O1|Outcome|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours~Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
236084|NCT01440881|E2|Reported Event|Placebo|"infuses at 0.01MCG/KG/min for 48 hours~Placebo: infuses at 0.01MCG/KG/min for 48 hours"
236085|NCT01440881|E1|Reported Event|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours~Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
236086|NCT01440816|B3|Baseline|Total|Total of all reporting groups
236087|NCT01440816|B2|Baseline|Cohort B: Tavo-EP|Patients in Cohort B received up to 4 cycles (3 daily treatments on Days 1, 5, and 8, per cycle) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, with 12 weeks planned between each cycle, lasting up to 12 months.
236088|NCT01440816|B1|Baseline|Cohort A: Tavo-EP|Patients in Cohort A received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, after which they proceeded to definitive treatment (surgery and/or radiation therapy) which started between 2 and 4 weeks after the first injection.
236089|NCT01440816|P2|Participant Flow|Cohort B: Tavo-EP|Patients in Cohort B received up to 4 cycles (3 daily treatments on Days 1, 5, and 8, per cycle) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, with 12 weeks planned between each cycle, lasting up to 12 months.
236090|NCT01440816|P1|Participant Flow|Cohort A: Tavo-EP|Patients in Cohort A received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, after which they proceeded to definitive treatment (surgery and/or radiation therapy) which started between 2 and 4 weeks after the first injection.
236095|NCT01440816|O1|Outcome|Cohort A: Tavo-EP|Patients in Cohort A received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, after which they proceeded to definitive treatment (surgery and/or radiation therapy) which started between 2 and 4 weeks after the first injection.
236096|NCT01440816|O1|Outcome|Cohort B: Tavo-EP|Patients in Cohort B received up to 4 cycles (3 daily treatments on Days 1, 5, and 8, per cycle) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, with 12 weeks planned between each cycle, lasting up to 12 months.
236097|NCT01440816|O1|Outcome|Cohort B: Tavo-EP|Patients in Cohort B received up to 4 cycles (3 daily treatments on Days 1, 5, and 8, per cycle) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, with 12 weeks planned between each cycle, lasting up to 12 months.
236098|NCT01440816|O2|Outcome|Cohort B: Tavo-EP|Patients in Cohort B received up to 4 cycles (3 daily treatments on Days 1, 5, and 8, per cycle) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, with 12 weeks planned between each cycle, lasting up to 12 months.
236099|NCT01440816|O1|Outcome|Cohort A: Tavo-EP|Patients in Cohort A received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, after which they proceeded to definitive treatment (surgery and/or radiation therapy) which started between 2 and 4 weeks after the first injection.
236100|NCT01440816|O1|Outcome|Cohort B: Tavo-EP|Patients in Cohort B received up to 4 cycles (3 daily treatments on Days 1, 5, and 8, per cycle) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, with 12 weeks planned between each cycle, lasting up to 12 months.
236101|NCT01440816|E2|Reported Event|Cohort B: Tavo-EP|Patients in Cohort B received up to 4 cycles (3 daily treatments on Days 1, 5, and 8, per cycle) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, with 12 weeks planned between each cycle, lasting up to 12 months.
236102|NCT01440816|E1|Reported Event|Cohort A: Tavo-EP|Patients in Cohort A received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, after which they proceeded to definitive treatment (surgery and/or radiation therapy) which started between 2 and 4 weeks after the first injection.
236103|NCT01440764|B3|Baseline|Total|Total of all reporting groups
236104|NCT01440764|B2|Baseline|F(80) Participants|Participants who consented to participate in the study and receive the Aerosol Furosemide (80mg/8ml solution of Saline) and two Aerosol Saline (8ml) Interventions in any sequence or receive the Aerosol Furosemide (80mg/8ml solution of Saline), Aerosol Saline (8ml), and IV Furosemide (15mg/8ml Saline) Interventions in any sequence.
236105|NCT01440764|B1|Baseline|F(40) Participants|Participants who consented to participate in the study and receive the Aerosol Furosemide (40mg/4ml solution of Saline), Aerosol Saline (4ml), and IV Furosemide (15mg/8ml Saline) Interventions in any sequence.
236106|NCT01440764|P7|Participant Flow|Saline, Then Saline, Then F(80)|"On Test Day 1, participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.~On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.~On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes."
236107|NCT01440764|P6|Participant Flow|Saline, Then F(80), Then Saline|"On Test Day 1, participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.~On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes.~On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes."
236108|NCT01440764|P5|Participant Flow|F(80), Then Saline, Then Saline|"On Test Day 1, participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes.~On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.~On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes."
236109|NCT01440764|P4|Participant Flow|Saline, Then F(80), Then IV.F|"On Test Day 1, participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes.~On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.~On Test Day 3 (at least 24 hours after Test Day 2), participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes."
236110|NCT01440764|P3|Participant Flow|Saline, Then F(40), Then IV.F|"On Test Day 1, participants received Aerosol Saline 4ml by inhalation for 5-10 minutes.~On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes.~On Test Day 3 (at least 24 hours after Test Day 2), participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes."
236111|NCT01440764|P2|Participant Flow|IV.F, Then F(40), Then Saline|"On Test Day 1, participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes.~On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes.~On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 4ml by inhalation for 5-10 minutes."
236112|NCT01440764|P1|Participant Flow|F(40), Then Saline, Then IV.F|"On Test Day 1, participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes.~On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 4ml by inhalation for 5-10 minutes.~On Test Day 3 (at least 24 hours after Test Day 2), participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes."
236113|NCT01440764|O5|Outcome|IV Furosemide|"Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes on 1 test day.~To be compared to Aerosol Furosemide (40mg) Arm and Aerosol Saline (4 ml) Arm.~Furosemide"
236114|NCT01440764|O4|Outcome|Aerosol Saline (8 ml)|"Aerosol Saline 8ml by inhalation for 5-10 minutes on 2 test days.~To be compared to Aerosol Furosemide (80mg) Arm.~Saline"
236115|NCT01440764|O3|Outcome|Aerosol Saline (4 ml)|"Aerosol Saline 4ml by inhalation for 5-10 minutes on 1 test day.~To be compared to Aerosol Furosemide (40mg) Arm and IV Furosemide Arm.~Saline"
236117|NCT01440764|O1|Outcome|Aerosol Furosemide (40 mg)|"Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes on 1 test day.~To be compared to Aerosol Saline (4ml) Arm and IV Furosemide Arm.~Furosemide"
236118|NCT01440764|O2|Outcome|Aerosol Furosemide (80mg)|"Participants who received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes on a single test day and met quality control.~Of the 12 participants who consented to receive this intervention, all 12 participants received the intervention and completed the study day. However, it was later discovered that 1 subject's data did not pass a priori requirements for quality control and the subject's data was excluded. Therefore, this analysis includes only the 11 subjects who met quality control."
236119|NCT01440764|O1|Outcome|Aerosol Furosemide (40 mg)|"Participants who received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes on a single test day and met quality control.~Of the 12 participants who consented to receive this intervention, all 12 participants received the intervention and completed the study day. However, it was later discovered that 1 subject had used cannabis recently and their information was discarded. Therefore, this analysis includes only the 11 subjects who met quality control."
236120|NCT01440764|O5|Outcome|Aerosol Saline (8 ml)|"Aerosol Saline 8ml by inhalation for 5-10 minutes on 2 test days and met quality control.~12 participants who consented to receive this intervention received the intervention and completed the study day. However, 1 subject's physiological data did not meet quality control and was discarded. Therefore, this analysis includes only the 11 subjects who met quality control."
236121|NCT01440764|O4|Outcome|Aerosol Furosemide (80mg)|"Participants who received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes on 1 test day and met quality control.~12 participants who consented to receive this intervention received the intervention and completed the study day. However, 1 subject's physiological data did not meet quality control and was discarded. Therefore, this analysis includes only the 11 subjects who met quality control."
236122|NCT01440764|O3|Outcome|IV Furosemide|"Participants who received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes on 1 test day and met quality control.~Of the 13 participants who consented to receive this intervention, only 12 participants received the intervention and completed the study day (one withdrew before starting this intervention).~Additionally, it was later discovered that 1 subject had used cannabis recently and their data was discarded. Also, 1 subject's data did not meet quality control and was excluded.~Therefore, this analysis includes only the 10 subjects who met quality control."
236123|NCT01440764|O2|Outcome|Aerosol Saline (4 ml)|"Participants who received Aerosol Saline (4ml) by inhalation for 5-10 minutes on a single test day and met quality control.~Of the 12 participants who consented to receive this intervention, only 11 participants received the intervention and completed the study day (one withdrew before starting this intervention).~Additionally, it was later discovered that 1 subject had used cannabis recently and their data was discarded.~Therefore, this analysis includes only the 10 subjects who met quality control."
236124|NCT01440764|O1|Outcome|Aerosol Furosemide (40 mg)|"Participants who received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes on a single test day and met quality control.~Of the 12 participants who consented to receive this intervention, all 12 participants received the intervention and completed the study day. However, it was later discovered that 1 subject had used cannabis recently and their information was discarded. Therefore, this analysis includes only the 11 subjects who met quality control."
236125|NCT01440764|E5|Reported Event|IV Furosemide|Any subject who received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes on 1 test day.
236126|NCT01440764|E4|Reported Event|Aerosol Saline (8 ml)|Any subject who received Aerosol Saline 8ml by inhalation for 5-10 minutes on 2 test days.
236127|NCT01440764|E3|Reported Event|Aerosol Saline (4 ml)|Any subject who received Aerosol Saline 4ml by inhalation for 5-10 minutes on 1 test day.
236128|NCT01440764|E2|Reported Event|Aerosol Furosemide (80mg)|Any subject who received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes on 1 test day.
236129|NCT01440764|E1|Reported Event|Aerosol Furosemide (40 mg)|Any subject who received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes on 1 test day.
236130|NCT01440647|B3|Baseline|Total|Total of all reporting groups
236131|NCT01440647|B2|Baseline|CPAP|After extubation this arm was placed on CPAP and was not offered NIPPV in the first month on life
236132|NCT01440647|B1|Baseline|NIPPV|Extubation to NIPPV (nasal intermittent positive pressure ventilation)
236133|NCT01440647|P2|Participant Flow|CPAP|After extubation this arm was placed on CPAP (continuous positive airway pressure)and was not offered NIPPV in the first month on life
236134|NCT01440647|P1|Participant Flow|NIPPV|Extubation to NIPPV (nasal intermittent positive pressure ventilation)
236135|NCT01440647|O2|Outcome|CPAP|Extubation to CPAP at the discretion of the medical team after extubation criteria were reached
236136|NCT01440647|O1|Outcome|NIPPV|Extubation to NIPPV when reaching extubation criteria
236137|NCT01440647|O2|Outcome|CPAP|Extubation to CPAP at the discretion of the medical team after extubation criteria were reached
236138|NCT01440647|O1|Outcome|NIPPV|Extubation to NIPPV when reaching extubation criteria
236139|NCT01440647|E2|Reported Event|CPAP|After extubation this arm was placed on CPAP and was not offered NIPPV in the first month on life
236140|NCT01440647|E1|Reported Event|NIPPV|Extubation to NIPPV (nasal intermittent positive pressure ventilation)
236141|NCT01440634|B3|Baseline|Total|Total of all reporting groups
236142|NCT01440634|B2|Baseline|Standard of Care|Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home.
236143|NCT01440634|B1|Baseline|Supervised Exercise|It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month.
236144|NCT01440634|P2|Participant Flow|Standard of Care|Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home.
236178|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
236145|NCT01440634|P1|Participant Flow|Supervised Exercise|It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month.
236146|NCT01440634|O2|Outcome|Standard of Care|Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home.
236147|NCT01440634|O1|Outcome|Supervised Exercise|It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month.
236148|NCT01440634|E2|Reported Event|Standard of Care|Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home.
236149|NCT01440634|E1|Reported Event|Supervised Exercise|It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month.
236150|NCT01440595|B3|Baseline|Total|Total of all reporting groups
236151|NCT01440595|B2|Baseline|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
236152|NCT01440595|B1|Baseline|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
236153|NCT01440595|P3|Participant Flow|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
236154|NCT01440595|P2|Participant Flow|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
236155|NCT01440595|P1|Participant Flow|Grazoprevir 200 mg + Peg-IFN + RBV|Grazoprevir 200 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
236156|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
236157|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
236158|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
236159|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
236160|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
236161|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
236162|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
236163|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
236164|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
236165|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
236166|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
236167|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
236168|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
236169|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
236170|NCT01440595|E2|Reported Event|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
236171|NCT01440595|E1|Reported Event|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
236172|NCT01440569|B3|Baseline|Total|Total of all reporting groups
236173|NCT01440569|B2|Baseline|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
236174|NCT01440569|B1|Baseline|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
236175|NCT01440569|P2|Participant Flow|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
236176|NCT01440569|P1|Participant Flow|Treatment-Naive|Treatment-naive participants received darunavir (DRV; 800 mg; 2 × 400 mg tablets) + cobicistat (COBI; 1 × 150 mg tablet) once daily + two nucleoside analogue reverse transcriptase inhibitors (NRTIs; per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
236177|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
236179|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
236180|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
236181|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
236182|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
236183|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
236184|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
236185|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
236186|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
236187|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
236188|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
236189|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
236190|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
236191|NCT01440569|E2|Reported Event|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
236192|NCT01440569|E1|Reported Event|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
236193|NCT01440543|B5|Baseline|Total|Total of all reporting groups
236194|NCT01440543|B4|Baseline|Air/Air|room air insufflation during both colonoscope insertion and withdrawal
236195|NCT01440543|B3|Baseline|Water/CO2|water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
236196|NCT01440543|B2|Baseline|CO2/CO2|CO2 insufflation during both colonoscope insertion and withdrawal
236197|NCT01440543|B1|Baseline|Water/Air|Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
236198|NCT01440543|P4|Participant Flow|Air/Air|room air insufflation during both colonoscope insertion and withdrawal
236199|NCT01440543|P3|Participant Flow|Water/CO2|water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
236200|NCT01440543|P2|Participant Flow|CO2/CO2|CO2 insufflation during both colonoscope insertion and withdrawal
236201|NCT01440543|P1|Participant Flow|Water/Air|Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
236202|NCT01440543|O4|Outcome|Air/Air|room air insufflation during both colonoscope insertion and withdrawal
236203|NCT01440543|O3|Outcome|Water/CO2|water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
236204|NCT01440543|O2|Outcome|Water/Air|Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
236205|NCT01440543|O1|Outcome|CO2/CO2|CO2 insufflation during both colonoscope insertion and withdrawal
236206|NCT01440543|E4|Reported Event|Air/Air|room air insufflation during both colonoscope insertion and withdrawal
236207|NCT01440543|E3|Reported Event|Water/CO2|water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
236208|NCT01440543|E2|Reported Event|CO2/CO2|CO2 insufflation during both colonoscope insertion and withdrawal
236209|NCT01440543|E1|Reported Event|Water/Air|Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
236210|NCT01440517|B1|Baseline|Tc99m-Maraciclatide Injection|The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
236211|NCT01440517|P1|Participant Flow|Tc99m-Maraciclatide Injection|The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
236212|NCT01440517|O1|Outcome|Tc99m-Maraciclatide Injection|The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
236213|NCT01440517|O1|Outcome|Tc99m-Maraciclatide Injection|The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
236214|NCT01440517|E1|Reported Event|Tc99m-Maraciclatide Injection|The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
236216|NCT01440387|B2|Baseline|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
236217|NCT01440387|B1|Baseline|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
236218|NCT01440387|P2|Participant Flow|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
236219|NCT01440387|P1|Participant Flow|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
236220|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
236221|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
236222|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
236223|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
236224|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
236225|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
236226|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
236227|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
236228|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
236229|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
236230|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
236231|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
236232|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
236233|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
236234|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
236235|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
236236|NCT01440387|E2|Reported Event|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
236237|NCT01440387|E1|Reported Event|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
236238|NCT01440374|B4|Baseline|Total|Total of all reporting groups
236239|NCT01440374|B3|Baseline|Part 2: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
236240|NCT01440374|B2|Baseline|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
236241|NCT01440374|B1|Baseline|Part 1: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. After all participants finished the 8 week treatment period, platelet response and safety were analyzed before initiating Part 2 of the study. Supportive standard of care was allowed as needed. The duration of Part 1 was 8 weeks.
236278|NCT01440322|B2|Baseline|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
236934|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
236242|NCT01440374|P4|Participant Flow|Part 3: Eltrombopag|"23 subjects of the 47 randomized to the placebo group in Part 2 entered part 3. 36 subjects of the 98 randomized to the Etrombopag group in Part 2 entered part 3.~All subjects received eltrombopag. Part 3 subjects could also have received treatment for their disease per local SOC, including azacitidine, decitabine, lenalidomide, and chemotherapy. The duration of Part 3 was to be 10 months for subjects from Part 1and 9 months for subjects from Part 2."
236243|NCT01440374|P3|Participant Flow|Part 2: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
236244|NCT01440374|P2|Participant Flow|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
236245|NCT01440374|P1|Participant Flow|Part 1: Eltrombopag|The eltrombopag starting dose the participants received was 100 milligrams (mg) daily (50 mg for participants of East Asian heritage). The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. After all participants finished the 8 week treatment period, platelet response and safety were analyzed before initiating Part 2 of the study. Supportive standard of care was allowed as needed. The duration of Part 1 was 8 weeks.
236246|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
236247|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
236248|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
236249|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
236250|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
236251|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
236252|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
236253|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
236254|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
236255|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
236256|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
236257|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
236258|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
236259|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
236260|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
236261|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
236262|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
236263|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
236264|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
236265|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
236266|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
236267|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
236268|NCT01440374|O1|Outcome|Part 2: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. After all participants finished the 8 week treatment period, platelet response and safety were analyzed before initiating Part 2 of the study. Supportive standard of care was allowed as needed. The duration of Part 1 was 8 weeks.
236269|NCT01440374|O1|Outcome|Part 1: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. After all participants finished the 8 week treatment period, platelet response and safety were analyzed before initiating Part 2 of the study. Supportive standard of care was allowed as needed. The duration of Part 1 was 8 weeks.
236270|NCT01440374|O2|Outcome|Part 2: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
236271|NCT01440374|O1|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
236272|NCT01440374|O1|Outcome|Part 1: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. After all participants finished the 8 week treatment period, platelet response and safety were analyzed before initiating Part 2 of the study. Supportive standard of care was allowed as needed. The duration of Part 1 was 8 weeks.
236273|NCT01440374|E4|Reported Event|Eltrombopag, Part 3 Plus 30 Days From Part 2 Subjects|Eltrombopag, Part 3 plus 30 Days from Part 2 subjects
236274|NCT01440374|E3|Reported Event|Placebo, Part 2 Plus 1 Day From Part 2 Subjects|Placebo, Part 2 plus 1 day from Part 2 subjects
236275|NCT01440374|E2|Reported Event|Eltrombopag, Part 2 Plus 1 Day From Part 2 Subjects|Eltrombopag, Part 2 plus 1 day from Part 2 subjects
236276|NCT01440374|E1|Reported Event|Eltrombopag, Part 1 Subjects|Eltrombopag, Part 1 subjects
236279|NCT01440322|B1|Baseline|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
236280|NCT01440322|P2|Participant Flow|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
236281|NCT01440322|P1|Participant Flow|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
236282|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
236283|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
236284|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
236285|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
236286|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
236287|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
236288|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
236289|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
236290|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
236291|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
236292|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
236293|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
236294|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
236295|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
236296|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
236297|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
236298|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
236299|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
236300|NCT01440322|E2|Reported Event|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
236301|NCT01440322|E1|Reported Event|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
236302|NCT01440283|B1|Baseline|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.~Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
236303|NCT01440283|P1|Participant Flow|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.~Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
236304|NCT01440283|O1|Outcome|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.~Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
236305|NCT01440283|O6|Outcome|Left Kidney: S-I|Nine participants who underwent all 3 scans.
236306|NCT01440283|O5|Outcome|Left Kidney: A-P|Nine participants who underwent all 3 scans.
236307|NCT01440283|O4|Outcome|Left Kidney: M-L|Nine participants who underwent all 3 scans.
236308|NCT01440283|O3|Outcome|Right Kidney: S-I|Nine participants who underwent all 3 scans.
236309|NCT01440283|O2|Outcome|Right Kidney: A-P|Nine participants who underwent all 3 scans.
236310|NCT01440283|O1|Outcome|Right Kidney: M-L|Nine participants who underwent all 3 scans.
236348|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
236349|NCT01440101|E3|Reported Event|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
236350|NCT01440101|E2|Reported Event|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
238697|NCT01433250|B3|Baseline|Total|Total of all reporting groups
236311|NCT01440283|O1|Outcome|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.~Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
236312|NCT01440283|O1|Outcome|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.~Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
236313|NCT01440283|E1|Reported Event|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.~Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
236314|NCT01440101|B4|Baseline|Total|Total of all reporting groups
236315|NCT01440101|B3|Baseline|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
236316|NCT01440101|B2|Baseline|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
236317|NCT01440101|B1|Baseline|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
236318|NCT01440101|P3|Participant Flow|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
236319|NCT01440101|P2|Participant Flow|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
236320|NCT01440101|P1|Participant Flow|Open Label Natalizumab|300 mg intravenous (IV) infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
236321|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
236322|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
236323|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
236324|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
236325|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
236326|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
236327|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
236328|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
236329|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
236330|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
236331|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
236332|NCT01440101|O1|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
236333|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
236334|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
236335|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
236336|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
236337|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
236338|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
236339|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
236340|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
236341|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
236342|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
236343|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
236344|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
236345|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
236346|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
236347|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
263461|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
236351|NCT01440101|E1|Reported Event|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
236352|NCT01440049|B1|Baseline|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236353|NCT01440049|P1|Participant Flow|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236354|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236355|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236356|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236357|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236358|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236359|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236360|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236361|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236362|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236363|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236364|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236365|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236366|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236367|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236368|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236369|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236370|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236371|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236372|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236373|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236935|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
236374|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236375|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236376|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236377|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236378|NCT01440049|E1|Reported Event|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
236379|NCT01439971|B6|Baseline|Total|Total of all reporting groups
236380|NCT01439971|B5|Baseline|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236381|NCT01439971|B4|Baseline|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236382|NCT01439971|B3|Baseline|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236383|NCT01439971|B2|Baseline|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236384|NCT01439971|B1|Baseline|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236385|NCT01439971|P5|Participant Flow|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236386|NCT01439971|P4|Participant Flow|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236387|NCT01439971|P3|Participant Flow|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236388|NCT01439971|P2|Participant Flow|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236389|NCT01439971|P1|Participant Flow|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236390|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236391|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236392|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236393|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236394|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236395|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236396|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236397|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236398|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236399|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236400|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236401|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236402|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236403|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236404|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236405|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236406|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236407|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236408|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236447|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236409|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236410|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236411|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236412|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236413|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236414|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236415|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236416|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236417|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236418|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236419|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236420|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236421|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236422|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236423|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236424|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236425|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236426|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236427|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236428|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236429|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236430|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236431|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236432|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236433|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236434|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236435|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236436|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236437|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236438|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236439|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236440|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236441|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236442|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236443|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236444|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236445|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236446|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
263462|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
236448|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236449|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236450|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236451|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236452|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236453|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236454|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236455|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236456|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236457|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236458|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236459|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236460|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236461|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236462|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236463|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236464|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236465|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236466|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236467|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236468|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236469|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236470|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236471|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236472|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236473|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236474|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236475|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236476|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236477|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236478|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236479|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236480|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236481|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236482|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236483|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236484|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236485|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
263463|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
236486|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236487|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236488|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236489|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236490|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236491|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236492|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236493|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236494|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236495|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236496|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236497|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236498|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236499|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236500|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236501|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236502|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236503|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236504|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236505|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236506|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236507|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236508|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236509|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236510|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236511|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236512|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236513|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236514|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236515|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236516|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236517|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236518|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236519|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236520|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236521|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236522|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236523|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236562|NCT01439971|E3|Reported Event|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236524|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236525|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236526|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236527|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236528|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236529|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236530|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236531|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236532|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236533|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236534|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236535|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236536|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236537|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236538|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236539|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236540|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236541|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236542|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236543|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236544|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236545|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236546|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236547|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236548|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236549|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236550|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236551|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236552|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236553|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236554|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236555|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236556|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236557|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236558|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236559|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236560|NCT01439971|E5|Reported Event|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236561|NCT01439971|E4|Reported Event|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236563|NCT01439971|E2|Reported Event|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
236564|NCT01439971|E1|Reported Event|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
236565|NCT01439945|B4|Baseline|Total|Total of all reporting groups
236566|NCT01439945|B3|Baseline|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.~Week 2:~Patients take one placebo tablets orally (PO) daily (QD).~Week 3:~Patients take two placebo tablets daily (QD).~Weeks 4-9:~Patients take two or three placebo tablets daily (QD)."
236567|NCT01439945|B2|Baseline|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
236568|NCT01439945|B1|Baseline|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
236569|NCT01439945|P4|Participant Flow|High Dose Placebo|"Week 2:~Patients take one placebo tablets orally (PO) daily (QD).~Week 3:~Patients take two placebo tablets daily (QD).~Weeks 4-9:~Patients take three placebo tablets daily (QD)."
236570|NCT01439945|P3|Participant Flow|Low Dose Placebo|"Week 2:~Patients take one placebo tablets orally (PO) daily (QD).~Week 3:~Patients take two placebo tablets daily (QD).~Weeks 4-9:~Patients take two placebo tablets daily (QD)."
236571|NCT01439945|P2|Participant Flow|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
236572|NCT01439945|P1|Participant Flow|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
236573|NCT01439945|O3|Outcome|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.~Week 2:~Patients take one placebo tablets orally (PO) daily (QD).~Week 3:~Patients take two placebo tablets daily (QD).~Weeks 4-9:~Patients take two or three placebo tablets daily (QD)."
236574|NCT01439945|O2|Outcome|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
236575|NCT01439945|O1|Outcome|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
236576|NCT01439945|O2|Outcome|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.~Week 2:~Patients take one placebo tablets orally (PO) daily (QD).~Week 3:~Patients take two placebo tablets daily (QD).~Weeks 4-9:~Patients take two or three placebo tablets daily (QD)."
236577|NCT01439945|O1|Outcome|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
236578|NCT01439945|O3|Outcome|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.~Week 2:~Patients take one placebo tablets orally (PO) daily (QD).~Week 3:~Patients take two placebo tablets daily (QD).~Weeks 4-9:~Patients take two or three placebo tablets daily (QD)."
236579|NCT01439945|O2|Outcome|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
236580|NCT01439945|O1|Outcome|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
236581|NCT01439945|O3|Outcome|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.~Week 2:~Patients take one placebo tablets orally (PO) daily (QD).~Week 3:~Patients take two placebo tablets daily (QD).~Weeks 4-9:~Patients take two or three placebo tablets daily (QD)."
236582|NCT01439945|O2|Outcome|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
236583|NCT01439945|O1|Outcome|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
236584|NCT01439945|O3|Outcome|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.~Week 2:~Patients take one placebo tablets orally (PO) daily (QD).~Week 3:~Patients take two placebo tablets daily (QD).~Weeks 4-9:~Patients take two or three placebo tablets daily (QD)."
236585|NCT01439945|O2|Outcome|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
236586|NCT01439945|O1|Outcome|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
236606|NCT01439867|O3|Outcome|Total|Participants received cinacalcet administered daily for 24 weeks.
263464|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
236587|NCT01439945|O3|Outcome|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.~Week 2:~Patients take one placebo tablets orally (PO) daily (QD).~Week 3:~Patients take two placebo tablets daily (QD).~Weeks 4-9:~Patients take two or three placebo tablets daily (QD)."
236588|NCT01439945|O2|Outcome|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
236589|NCT01439945|O1|Outcome|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
236590|NCT01439945|E4|Reported Event|Optional Continuation Phase|After the double blind phase patient questionnaire booklet has been completed and returned to the investigator, the patient will be told whether she was on magnesium or placebo. If the patient wishes to continue or start the magnesium, and healthcare provider approves that this is an appropriate option, she may be registered on the Optional Continuation Phase of the study. This phase will last up to 4 weeks of treatment following either 800 or 1200 mg/day treatment group.
236591|NCT01439945|E3|Reported Event|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.~Week 2:~Patients take one placebo tablets orally (PO) daily (QD).~Week 3:~Patients take two placebo tablets daily (QD).~Weeks 4-9:~Patients take two or three placebo tablets daily (QD)."
236592|NCT01439945|E2|Reported Event|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
236593|NCT01439945|E1|Reported Event|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
236594|NCT01439867|B3|Baseline|Total|Total of all reporting groups
236595|NCT01439867|B2|Baseline|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
236596|NCT01439867|B1|Baseline|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
236597|NCT01439867|P2|Participant Flow|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
236598|NCT01439867|P1|Participant Flow|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
236599|NCT01439867|O2|Outcome|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
236600|NCT01439867|O1|Outcome|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
236601|NCT01439867|O2|Outcome|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
236602|NCT01439867|O1|Outcome|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
236603|NCT01439867|O3|Outcome|Total|Participants received cinacalcet administered daily for 24 weeks.
236604|NCT01439867|O2|Outcome|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
236605|NCT01439867|O1|Outcome|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
236607|NCT01439867|O2|Outcome|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
236608|NCT01439867|O1|Outcome|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
236609|NCT01439867|O3|Outcome|Total|Participants received cinacalcet administered daily for 24 weeks.
236610|NCT01439867|O2|Outcome|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
236611|NCT01439867|O1|Outcome|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
236612|NCT01439867|O3|Outcome|Total|Participants received cinacalcet administered daily for 24 weeks.
236613|NCT01439867|O2|Outcome|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
236614|NCT01439867|O1|Outcome|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
236615|NCT01439867|O3|Outcome|Total|Participants received cinacalcet administered daily for 24 weeks.
236616|NCT01439867|O2|Outcome|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
236617|NCT01439867|O1|Outcome|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
236618|NCT01439867|O3|Outcome|Total|Participants received cinacalcet administered daily for 24 weeks.
236619|NCT01439867|O2|Outcome|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
236620|NCT01439867|O1|Outcome|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
236621|NCT01439867|O3|Outcome|Total|Participants received cinacalcet administered daily for 24 weeks.
236622|NCT01439867|O2|Outcome|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
236623|NCT01439867|O1|Outcome|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
236624|NCT01439867|O3|Outcome|Total|Participants received cinacalcet administered daily for 24 weeks.
236625|NCT01439867|O2|Outcome|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
236626|NCT01439867|O1|Outcome|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
236627|NCT01439867|O3|Outcome|Total|Participants received cinacalcet administered daily for 24 weeks.
236660|NCT01439373|B3|Baseline|Total|Total of all reporting groups
236628|NCT01439867|O2|Outcome|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
236629|NCT01439867|O1|Outcome|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
236630|NCT01439867|O3|Outcome|Total|Participants received cinacalcet administered daily for 24 weeks.
236631|NCT01439867|O2|Outcome|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
236632|NCT01439867|O1|Outcome|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
236633|NCT01439867|E3|Reported Event|Total|Participants received cinacalcet administered daily for 24 weeks.
236634|NCT01439867|E2|Reported Event|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
236635|NCT01439867|E1|Reported Event|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
236636|NCT01439724|B3|Baseline|Total|Total of all reporting groups
236637|NCT01439724|B2|Baseline|Low Level Laser Therapy|"The investigators used a diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.~Low Level Laser Therapy- (DMC, São Paulo, Brazil): Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region."
236638|NCT01439724|B1|Baseline|Placebo|"Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.~Placebo (DMC, São Paulo, Brazil): The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light."
236639|NCT01439724|P2|Participant Flow|Low Level Laser Therapy|"The investigators used a diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100mW, 4 Joules(J)/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.~Low Level Laser Therapy- (DMC, São Paulo, Brazil): Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region."
236640|NCT01439724|P1|Participant Flow|Placebo|"Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.~Placebo (DMC, São Paulo, Brazil): The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light."
236641|NCT01439724|O2|Outcome|Low Level Laser Therapy|"The investigators used a diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.~Low Level Laser Therapy- (DMC, São Paulo, Brazil): Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region."
236642|NCT01439724|O1|Outcome|Placebo|"Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.~Placebo (DMC, São Paulo, Brazil): The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light."
236711|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
236643|NCT01439724|E2|Reported Event|Low Level Laser Therapy|"The investigators used a diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.~Low Level Laser Therapy- (DMC, São Paulo, Brazil): Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region."
236644|NCT01439724|E1|Reported Event|Placebo|"Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.~Placebo (DMC, São Paulo, Brazil): The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light."
236645|NCT01439711|B1|Baseline|Letrozole + MRI|Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.
236646|NCT01439711|P1|Participant Flow|Letrozole + MRI|Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.
236647|NCT01439711|O1|Outcome|Letrozole + MRI|Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.
236648|NCT01439711|O1|Outcome|Letrozole + MRI|Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.
236649|NCT01439711|O1|Outcome|Letrozole + MRI|Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.
236650|NCT01439711|O1|Outcome|Letrozole + MRI|Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.
236651|NCT01439711|O1|Outcome|Letrozole + MRI|Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.
236652|NCT01439711|O1|Outcome|Letrozole + MRI|Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.
236653|NCT01439711|O1|Outcome|Letrozole + MRI|Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.
236654|NCT01439711|O1|Outcome|Letrozole + MRI|Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.
236655|NCT01439711|E1|Reported Event|Letrozole + MRI|Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.
236656|NCT01439672|B1|Baseline|Insulin Sensitivity|"Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity.~Mixed meal and insulin challenge: The subject will undergo a mixed meal and insulin challenge as follows: an insulin bolus will be administered and a mixed meal nutrition drink will be consumed over 1-5 minutes. The mixed meal nutrition drink will be selected for that individual to be most likely to raise the glucose levels by 100mg/dl and then return to baseline within a four-hour time period. The nutrition drink will selected from the following types of product lines: Boost products (Nestle Nutrition), Ensure products (Abbott Nutrition), Carnation Instant Breakfast (Nestle Nutrition) or Glucerna (Abbott Nutrition).The pre-meal insulin bolus will be calculated to bring the subject to ~100mg/dl at 1100."
236657|NCT01439672|P1|Participant Flow|Insulin Sensitivity|"Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity.~Mixed meal and insulin challenge: The subject will undergo a mixed meal and insulin challenge as follows: an insulin bolus will be administered and a mixed meal nutrition drink will be consumed over 1-5 minutes. The mixed meal nutrition drink will be selected for that individual to be most likely to raise the glucose levels by 100mg/dl and then return to baseline within a four-hour time period. The nutrition drink will selected from the following types of product lines: Boost products (Nestle Nutrition), Ensure products (Abbott Nutrition), Carnation Instant Breakfast (Nestle Nutrition) or Glucerna (Abbott Nutrition).The pre-meal insulin bolus will be calculated to bring the subject to ~100mg/dl at 1100."
236658|NCT01439672|O1|Outcome|Insulin Sensitivity|"Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity. Each subject will be admitted twice approximately 3 weeks apart.~Mixed meal and insulin challenge: The subject will undergo a mixed meal and insulin challenge as follows: an insulin bolus will be administered and a mixed meal nutrition drink will be consumed over 1-5 minutes. The mixed meal nutrition drink will be selected for that individual to be most likely to raise the glucose levels by 100mg/dl and then return to baseline within a four-hour time period. The nutrition drink will selected from the following types of product lines: Boost products (Nestle Nutrition), Ensure products (Abbott Nutrition), Carnation Instant Breakfast (Nestle Nutrition) or Glucerna (Abbott Nutrition).The pre-meal insulin bolus will be calculated to bring the subject to ~100mg/dl at 1100."
236659|NCT01439672|E1|Reported Event|Insulin Sensitivity|"Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity.~Mixed meal and insulin challenge: The subject will undergo a mixed meal and insulin challenge as follows: an insulin bolus will be administered and a mixed meal nutrition drink will be consumed over 1-5 minutes. The mixed meal nutrition drink will be selected for that individual to be most likely to raise the glucose levels by 100mg/dl and then return to baseline within a four-hour time period. The nutrition drink will selected from the following types of product lines: Boost products (Nestle Nutrition), Ensure products (Abbott Nutrition), Carnation Instant Breakfast (Nestle Nutrition) or Glucerna (Abbott Nutrition).The pre-meal insulin bolus will be calculated to bring the subject to ~100mg/dl at 1100."
236661|NCT01439373|B2|Baseline|Placebo + PEG + RIBA|Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236662|NCT01439373|B1|Baseline|GSK2336805 60 mg + PEG + RIBA|Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236663|NCT01439373|P2|Participant Flow|Placebo + PEG + RIBA|Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236664|NCT01439373|P1|Participant Flow|GSK2336805 60 mg + PEG + RIBA|Eligible participants received GSK2336805 60 milligram (mg) orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with peginterferon alfa-2a (PEG) 180 microgram (mcg) per week as subcutaneous injection (SC) and ribavirin (RIBA) 1000 mg (if <75 kilogram [kg]) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236665|NCT01439373|O1|Outcome|GSK2336805 60 mg (Part A)|Eligible participants received GSK2336805 60 mg once daily on Day 1 (Part A) of the study
236666|NCT01439373|O1|Outcome|GSK2336805 60 mg|Eligible participants received GSK2336805 60 mg once daily on Day 1 (Part A) of the study
236667|NCT01439373|O1|Outcome|GSK2336805 60 mg (Part A)|Eligible participants received GSK2336805 60 mg once daily on Day 1 (Part A) of the study
236668|NCT01439373|O1|Outcome|GSK2336805 60 mg (Part A)|Eligible participants received GSK2336805 60 mg once daily on Day 1 (Part A) of the study
236669|NCT01439373|O1|Outcome|GSK2336805 60 mg (Part A)|Eligible participants received GSK2336805 60 mg once daily on Day 1 (Part A) of the study
236670|NCT01439373|O2|Outcome|Placebo + PEG + RIBA|Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236671|NCT01439373|O1|Outcome|GSK2336805 60 mg + PEG + RIBA|Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236672|NCT01439373|O2|Outcome|Placebo + PEG + RIBA|Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236673|NCT01439373|O1|Outcome|GSK2336805 60 mg + PEG + RIBA|Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236674|NCT01439373|O2|Outcome|Placebo + PEG + RIBA|Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236675|NCT01439373|O1|Outcome|GSK2336805 60 mg + PEG + RIBA|Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236676|NCT01439373|O2|Outcome|Placebo + PEG + RIBA|Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236677|NCT01439373|O1|Outcome|GSK2336805 60 mg + PEG + RIBA|Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236678|NCT01439373|O2|Outcome|Placebo + PEG + RIBA|Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236679|NCT01439373|O1|Outcome|GSK2336805 60 mg + PEG + RIBA|Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236680|NCT01439373|O2|Outcome|Placebo + PEG + RIBA|Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236681|NCT01439373|O1|Outcome|GSK2336805 60 mg + PEG + RIBA|Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236682|NCT01439373|O2|Outcome|Placebo + PEG + RIBA|Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236683|NCT01439373|O1|Outcome|GSK2336805 60 mg + PEG + RIBA|Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236684|NCT01439373|O2|Outcome|Placebo + PEG + RIBA|Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236685|NCT01439373|O1|Outcome|GSK2336805 60 mg + PEG + RIBA|Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236686|NCT01439373|O2|Outcome|Placebo + PEG + RIBA|Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236687|NCT01439373|O1|Outcome|GSK2336805 60 mg + PEG + RIBA|Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236688|NCT01439373|O2|Outcome|Placebo + PEG + RIBA|Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236689|NCT01439373|O1|Outcome|GSK2336805 60 mg + PEG + RIBA|Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236690|NCT01439373|O2|Outcome|Placebo (Part A)|Eligible participants received matching placebo once daily on Day 1 (Part A) of the study
236691|NCT01439373|O1|Outcome|GSK2336805 60 mg (Part A)|Eligible participants received GSK2336805 60 mg once daily on Day 1 (Part A) of the study.
236692|NCT01439373|O2|Outcome|Placebo + PEG + RIBA|Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236693|NCT01439373|O1|Outcome|GSK2336805 60 mg + PEG + RIBA|Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236694|NCT01439373|O2|Outcome|Placebo + PEG + RIBA|Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236695|NCT01439373|O1|Outcome|GSK2336805 60 mg + PEG + RIBA|Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236696|NCT01439373|O2|Outcome|Placebo + PEG + RIBA|Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236697|NCT01439373|O1|Outcome|GSK2336805 60 mg + PEG + RIBA|Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236698|NCT01439373|O2|Outcome|Placebo + PEG + RIBA|Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236699|NCT01439373|O1|Outcome|GSK2336805 60 mg + PEG + RIBA|Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236700|NCT01439373|O2|Outcome|Placebo + PEG + RIBA|Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236701|NCT01439373|O1|Outcome|GSK2336805 60 mg + PEG + RIBA|Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236702|NCT01439373|E2|Reported Event|Placebo + PEG + RIBA|Eligible participants received matching placebo orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of matching placebo once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236703|NCT01439373|E1|Reported Event|GSK2336805 60 mg + PEG + RIBA|Eligible participants received GSK2336805 60 mg orally once daily on Day 1 (Part A) of the study. Part 2 of the study then proceeded without interruption with the co-administration of GSK2336805 60 mg once daily with PEG 180 mcg per week as SC and RIBA 1000 mg (if <75 kg) or 1200 mg (if <75 kg) orally in 2 divided doses with food (morning and evening) (2 or three 200 mg tablets in the morning and three 200 mg tablets in the evening) through 4 weeks of treatment from Day 2 through Day 28 of the study.
236704|NCT01439360|B3|Baseline|Total|Total of all reporting groups
236705|NCT01439360|B2|Baseline|Control|In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
236706|NCT01439360|B1|Baseline|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
236707|NCT01439360|P2|Participant Flow|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
236708|NCT01439360|P1|Participant Flow|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
236709|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
236710|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
236712|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
236713|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
236714|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
236715|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
236716|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
236717|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
236718|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
236719|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
236720|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
236721|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
236722|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
236723|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
236724|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
236725|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
236726|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
236727|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
236728|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
236729|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
236730|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
236731|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
236732|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
236733|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
236734|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
236735|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
236736|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
236737|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
236738|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
236739|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
236740|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
236741|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
236742|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
236743|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
236744|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
236745|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
236746|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
236747|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
236748|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
236749|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
263465|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
236751|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
236752|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
236753|NCT01439360|E2|Reported Event|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
236754|NCT01439360|E1|Reported Event|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
236755|NCT01439282|B3|Baseline|Total|Total of all reporting groups
236756|NCT01439282|B2|Baseline|Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine|Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
236757|NCT01439282|B1|Baseline|Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
236758|NCT01439282|P2|Participant Flow|Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine|Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
236759|NCT01439282|P1|Participant Flow|Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an intravenous (IV) infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally twice a day (BID) on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
236760|NCT01439282|O2|Outcome|Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine|Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
236761|NCT01439282|O1|Outcome|Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
236762|NCT01439282|O2|Outcome|Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine|Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
236763|NCT01439282|O1|Outcome|Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
236764|NCT01439282|E2|Reported Event|Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
236765|NCT01439282|E1|Reported Event|Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
236766|NCT01439204|B3|Baseline|Total|Total of all reporting groups
236767|NCT01439204|B2|Baseline|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236768|NCT01439204|B1|Baseline|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236769|NCT01439204|P2|Participant Flow|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236770|NCT01439204|P1|Participant Flow|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236771|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236772|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236773|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236774|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236775|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236776|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236777|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236778|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236779|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236780|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236781|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236782|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236783|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236784|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236785|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236786|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236787|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236788|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236789|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236790|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236791|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236792|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236793|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236794|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236795|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236856|NCT01438996|B2|Baseline|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
236796|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236797|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236798|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236799|NCT01439204|E2|Reported Event|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236800|NCT01439204|E1|Reported Event|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
236801|NCT01439165|B3|Baseline|Total|Total of all reporting groups
236802|NCT01439165|B2|Baseline|Td Adsorbed Vaccine|Healthy adults <65 years of age who received Adacel 10 years ago received TENIVAC® (Td Adsorbed vaccine).
236803|NCT01439165|B1|Baseline|Adacel Vaccine|Healthy adults <65 years of age who received Adacel 10 years ago received a repeat dose of Adacel vaccine.
236804|NCT01439165|P2|Participant Flow|Td Adsorbed Vaccine|Healthy adults <65 years of age who received Adacel 10 years ago received TENIVAC® (Td Adsorbed vaccine).
236805|NCT01439165|P1|Participant Flow|Adacel Vaccine|Healthy adults <65 years of age who received Adacel 10 years ago received a repeat dose of Adacel vaccine.
236806|NCT01439165|O2|Outcome|Td Adsorbed Vaccine|Healthy adults <65 years of age who received Adacel 10 years ago received TENIVAC® (Td Adsorbed vaccine).
236807|NCT01439165|O1|Outcome|Adacel Vaccine|Healthy adults <65 years of age who received Adacel 10 years ago received a repeat dose of Adacel vaccine.
236808|NCT01439165|O1|Outcome|Adacel Vaccine|Healthy adults <65 years of age who received Adacel 10 years ago received a repeat dose of Adacel vaccine.
236809|NCT01439165|O1|Outcome|Adacel Vaccine|Healthy adults <65 years of age who received Adacel 10 years ago received a repeat dose of Adacel vaccine.
236810|NCT01439165|O2|Outcome|Td Adsorbed Vaccine|Healthy adults <65 years of age who received Adacel 10 years ago received TENIVAC® (Td Adsorbed vaccine).
236811|NCT01439165|O1|Outcome|Adacel Vaccine|Healthy adults <65 years of age who received Adacel 10 years ago received a repeat dose of Adacel vaccine.
236812|NCT01439165|O2|Outcome|Td Adsorbed Vaccine|Healthy adults <65 years of age who received Adacel 10 years ago received TENIVAC® (Td Adsorbed vaccine).
236813|NCT01439165|O1|Outcome|Adacel Vaccine|Healthy adults <65 years of age who received Adacel 10 years ago received a repeat dose of Adacel vaccine.
236814|NCT01439165|E2|Reported Event|Td Adsorbed Vaccine|Healthy adults <65 years of age who received Adacel 10 years ago received TENIVAC® (Td Adsorbed vaccine).
236815|NCT01439165|E1|Reported Event|Adacel Vaccine|Healthy adults <65 years of age who received Adacel 10 years ago received a repeat dose of Adacel vaccine.
236816|NCT01439126|B3|Baseline|Total|Total of all reporting groups
236817|NCT01439126|B2|Baseline|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
236818|NCT01439126|B1|Baseline|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
236819|NCT01439126|P2|Participant Flow|Subjects on Placebo|"Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study~Of 67 Subjects randomized to Placebo:~26 (38.8%) oral dose of 0.4 mg/day 24 (35.8%) oral dose of 0.3 mg/day 15 (22.4%) oral dose of 0.2 mg/day 2 (3.0%) oral dose of 0.1 mg/day"
236820|NCT01439126|P1|Participant Flow|Subjects on KAPVAY (Clonidine Hydrochloride)|"Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period.~All subjects were given study medication at the baseline visit (Visit 2, open label) and instructed to take 1 x 0.1 mg tablet each evening (Day 1) at bedtime until the next visit. Subjects who required an increase in total dose to 0.2 mg/day took 1 x 0.1 mg tablet (0.1 mg) in the morning and at bedtime until the next visit. Those who required a further increase in dose to 0.3 mg/day took 1 x 0.1 mg tablet in the morning and 2 x 0.1 mg tablets at bedtime until the next visit. Patient increasing dose to 0.4 mg/day were instructed to take 2 x 0.1 mg tablets in the morning and at bedtime until the next visit.~Of 68 Subjects randomized to KAPVAY:~24 (35.3%) oral dose of 0.4 mg/day 25 (36.8%) oral dose of 0.3 mg/day 14 (20.6%) oral dose of 0.2 mg/day 5 (7.4%) oral dose of 0.1 mg/day"
236821|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
236822|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
236823|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
236824|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
236857|NCT01438996|B1|Baseline|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
236825|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
236826|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
236827|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
236828|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
236829|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
236830|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
236831|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
236832|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
236833|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
236834|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
236835|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
236836|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
236837|NCT01439126|E2|Reported Event|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
236838|NCT01439126|E1|Reported Event|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
236839|NCT01439074|B3|Baseline|Total|Total of all reporting groups
236840|NCT01439074|B2|Baseline|SSD Ag Cream|"Silver Sulphadiazine Ag white cream, 1% SSD Ag, 40g/tube~Silver sulphadiazine: Cream"
236841|NCT01439074|B1|Baseline|Mepilex Ag|"Mepilex Ag consists of a Safetac® soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.~Mepilex Ag: Dressing"
236842|NCT01439074|P2|Participant Flow|SSD Ag Cream|"Silver Sulphadiazine Ag cream~Silver sulphadiazine: Cream"
236843|NCT01439074|P1|Participant Flow|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.~Mepilex Ag: Dressing"
236844|NCT01439074|O2|Outcome|SSD Ag Cream|"Silver Sulphadiazine Ag cream~Silver sulphadiazine: Cream"
236845|NCT01439074|O1|Outcome|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.~Mepilex Ag: Dressing"
236846|NCT01439074|O2|Outcome|SSD Ag Cream|"Silver Sulphadiazine Ag cream~Silver sulphadiazine: Cream"
236847|NCT01439074|O1|Outcome|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.~Mepilex Ag: Dressing"
236848|NCT01439074|O2|Outcome|SSD Ag Cream|"Silver Sulphadiazine Ag cream~Silver sulphadiazine: Cream"
236849|NCT01439074|O1|Outcome|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.~Mepilex Ag: Dressing"
236850|NCT01439074|O2|Outcome|SSD Ag Cream|"Silver Sulphadiazine Ag cream~Silver sulphadiazine: Cream"
236851|NCT01439074|O1|Outcome|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.~Mepilex Ag: Dressing"
236852|NCT01439074|E2|Reported Event|SSD Ag Cream|"Silver Sulphadiazine Ag cream~Silver sulphadiazine: Cream"
236853|NCT01439074|E1|Reported Event|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.~Mepilex Ag: Dressing"
236854|NCT01438996|B4|Baseline|Total|Total of all reporting groups
236855|NCT01438996|B3|Baseline|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
236859|NCT01438996|P2|Participant Flow|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
236860|NCT01438996|P1|Participant Flow|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
236861|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
236862|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
236863|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
236864|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
236865|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
236866|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
236867|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
236868|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
236869|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
236870|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
236871|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
236872|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
236873|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
236874|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
236875|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
236876|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
236877|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
236878|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
236879|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
236880|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
236881|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
236882|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
236883|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
236884|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
236885|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
236886|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
236887|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
236888|NCT01438996|E3|Reported Event|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
236889|NCT01438996|E2|Reported Event|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
236890|NCT01438996|E1|Reported Event|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
236891|NCT01438840|B3|Baseline|Total|Total of all reporting groups
236892|NCT01438840|B2|Baseline|Avatrombopag (Core Study)|Avatrombopag was administered orally as 5 mg, 10 mg, 20 mg, 30 mg, or 40 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 20 mg avatrombopag, one daily and they were allowed to have their dose titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on their response to study drug.
236893|NCT01438840|B1|Baseline|Placebo (Core Study)|Placebo was administered as 5 mg, 10 mg, 20 mg, 30 mg or 40 mg in a flexible dose design for 26 weeks. Placebo was administered orally at a starting dose of 20 mg, once daily. Afterwards the dose could be titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on the participant's response to the study drug; placebo titration was used to maintain the blind.
236894|NCT01438840|P3|Participant Flow|Avatrombopag (Extension Phase)|Participants who met all the eligibility criteria requirements of extension phase and who discontinued the core study because of lack of treatment effect continued into the extension phase. Avatrombopag was administered to participants who entered extension phase, with a starting dose of 20 mg avatrombopag, once daily for 76 weeks and underwent dose titration.
236895|NCT01438840|P2|Participant Flow|Avatrombopag (Core Study)|Avatrombopag was administered orally as 5 mg, 10 mg, 20 mg, 30 mg, or 40 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 20 mg avatrombopag, one daily and they were allowed to have their dose titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on their response to study drug.
236896|NCT01438840|P1|Participant Flow|Placebo (Core Study)|Placebo was administered as 5 mg, 10 mg, 20 mg, 30 mg or 40 mg in a flexible dose design for 26 weeks. Placebo was administered orally at a starting dose of 20 mg, once daily. Afterwards the dose could be titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on the participant's response to the study drug; placebo titration was used to maintain the blind.
236897|NCT01438840|O2|Outcome|Avatrombopag (Core Study)|Avatrombopag was administered orally as 5 mg, 10 mg, 20 mg, 30 mg, or 40 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 20 mg avatrombopag, one daily and they were allowed to have their dose titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on their response to study drug.
236898|NCT01438840|O1|Outcome|Placebo (Core Study)|Placebo was administered as 5 mg, 10 mg, 20 mg, 30 mg or 40 mg in a flexible dose design for 26 weeks. Placebo was administered orally at a starting dose of 20 mg, once daily. Afterwards the dose could be titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on the participant's response to the study drug; placebo titration was used to maintain the blind.
236899|NCT01438840|O2|Outcome|Avatrombopag (Core Study)|Avatrombopag was administered orally as 5 mg, 10 mg, 20 mg, 30 mg, or 40 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 20 mg avatrombopag, one daily and they were allowed to have their dose titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on their response to study drug.
236900|NCT01438840|O1|Outcome|Placebo (Core Study)|Placebo was administered as 5 mg, 10 mg, 20 mg, 30 mg or 40 mg in a flexible dose design for 26 weeks. Placebo was administered orally at a starting dose of 20 mg, once daily. Afterwards the dose could be titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on the participant's response to the study drug; placebo titration was used to maintain the blind.
236901|NCT01438840|O2|Outcome|Avatrombopag (Core Study)|Avatrombopag was administered orally as 5 mg, 10 mg, 20 mg, 30 mg, or 40 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 20 mg avatrombopag, one daily and they were allowed to have their dose titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on their response to study drug.
236902|NCT01438840|O1|Outcome|Placebo (Core Study)|Placebo was administered as 5 mg, 10 mg, 20 mg, 30 mg or 40 mg in a flexible dose design for 26 weeks. Placebo was administered orally at a starting dose of 20 mg, once daily. Afterwards the dose could be titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on the participant's response to the study drug; placebo titration was used to maintain the blind.
236903|NCT01438840|E3|Reported Event|Avatrombopag (Extension Phase)|Participants who met all eligibility criteria requirements of extension phase and who discontinued the core study because of lack of treatment effect continued into the extension phase. Avatrombopag was administered to participants who entered extension phase, with a starting dose of 20 mg avatrombopag, once daily for 76 weeks and underwent dose titration.
236904|NCT01438840|E2|Reported Event|Avatrombopag (Core Study)|Avatrombopag was administered orally as 5 mg, 10 mg, 20 mg, 30 mg, or 40 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 20 mg avatrombopag, one daily and they were allowed to have their dose titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on their response to study drug.
236905|NCT01438840|E1|Reported Event|Placebo (Core Study)|Placebo was administered as 5 mg, 10 mg, 20 mg, 30 mg or 40 mg in a flexible dose design for 26 weeks. Placebo was administered orally at a starting dose of 20 mg, once daily. Afterwards the dose could be titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on the participant's response to the study drug; placebo titration was used to maintain the blind.
236906|NCT01438814|B3|Baseline|Total|Total of all reporting groups
236907|NCT01438814|B2|Baseline|Met Bid|Patients treated with metformin alone twice daily.
236908|NCT01438814|B1|Baseline|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
236909|NCT01438814|P2|Participant Flow|Met Bid|Patients treated with metformin alone twice daily.
236910|NCT01438814|P1|Participant Flow|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
236911|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
236912|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
236913|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
236914|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
236915|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
236916|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
236917|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
236918|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
236919|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
236920|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
236921|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
236922|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
236923|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
236924|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
236925|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
236926|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
236927|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
236928|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
236929|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
236930|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
236931|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
236932|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
236933|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
236936|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
236937|NCT01438814|E2|Reported Event|Met Bid|Patients treated with metformin alone twice daily.
236938|NCT01438814|E1|Reported Event|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
236939|NCT01438710|B1|Baseline|Prograf|"Tacrolimus capsules for twice daily oral administration~Prograf: Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice."
236940|NCT01438710|P2|Participant Flow|Prograf|"All patients received Prograf/generic Tacrolimus capsules for twice daily oral administration during the first week of treatment.~Prograf: Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice."
236941|NCT01438710|P1|Participant Flow|LCP-Tacro|"After the first weeks treatment with Prograf/generic Tacrolimus, all patients were switched to LCP Tacro tables for once daily oral administration for one week.~LCP-Tacro: LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL."
236942|NCT01438710|O1|Outcome|LCP-Tacro|"After the first weeks treatment with Prograf/generic Tacrolimus, all patients were switched to LCP Tacro tables for once daily oral administration for one week.~LCP-Tacro: LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL."
236943|NCT01438710|E2|Reported Event|Prograf|"All patients received Prograf/generic Tacrolimus capsules for twice daily oral administration during the first week of treatment.~Prograf: Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice."
236944|NCT01438710|E1|Reported Event|LCP-Tacro|"After the first weeks treatment with Prograf/generic Tacrolimus, all patients were switched to LCP Tacro tables for once daily oral administration for one week.~LCP-Tacro: LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL."
236945|NCT01438541|B1|Baseline|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
236946|NCT01438541|P1|Participant Flow|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
236947|NCT01438541|O1|Outcome|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
236948|NCT01438541|O1|Outcome|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
236949|NCT01438541|O1|Outcome|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
236950|NCT01438541|E1|Reported Event|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
236951|NCT01438489|B4|Baseline|Total|Total of all reporting groups
236952|NCT01438489|B3|Baseline|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236953|NCT01438489|B2|Baseline|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236954|NCT01438489|B1|Baseline|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
236955|NCT01438489|P3|Participant Flow|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236956|NCT01438489|P2|Participant Flow|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236957|NCT01438489|P1|Participant Flow|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
236958|NCT01438489|O2|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236959|NCT01438489|O1|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236960|NCT01438489|O2|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236961|NCT01438489|O1|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236962|NCT01438489|O2|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236963|NCT01438489|O1|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236964|NCT01438489|O2|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236965|NCT01438489|O1|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236966|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236967|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236968|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
236969|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236970|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
263466|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
236971|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
236972|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236973|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236974|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
236975|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236976|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236977|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
236978|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236979|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236980|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
236981|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236982|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236983|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
236984|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236985|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236986|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
236987|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236988|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236989|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
236990|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236991|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236992|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
236993|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236994|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236995|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
236996|NCT01438489|E3|Reported Event|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236997|NCT01438489|E2|Reported Event|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
236998|NCT01438489|E1|Reported Event|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
236999|NCT01438424|B1|Baseline|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir once daily (QD) with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
237000|NCT01438424|P1|Participant Flow|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir once daily (QD) with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
237001|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
237002|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
237003|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
237004|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
237005|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
237006|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg QD, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine. All participants, regardless of dosing or regimen, included in these safety analyses.
237007|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
237008|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
237009|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
237153|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237010|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
237011|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg QD, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine. All participants, regardless of dosing or regimen, included in these safety analyses.
237012|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
237013|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
237014|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
237015|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
237016|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
237017|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
237018|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
237019|NCT01438424|O1|Outcome|Entecavir, 1.0 mg, With or Without Lamivudine|Participants received 1 mg of entecavir QD with or without lamivudine.
237020|NCT01438424|O1|Outcome|Entecavir, 1.0 mg, With or Without Lamivudine|Participants received 1 mg of entecavir QD with or without lamivudine.
237021|NCT01438424|O1|Outcome|Entecavir, 1.0 mg, With or Without Lamivudine|Participants received 1 mg of entecavir QD with or without lamivudine.
237022|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
237023|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg QD, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir once daily (QD) with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine. All participants, regardless of dosing or regimen, included in these safety analyses.
237024|NCT01438424|O1|Outcome|Entecavir, 1.0 mg, With or Without Lamivudine|Participants received 1 mg of entecavir QD with or without lamivudine.
237025|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
237026|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
237027|NCT01438424|E8|Reported Event|Placebo|Participants originally assigned to placebo before protocol change to study drug.
237028|NCT01438424|E7|Reported Event|Missing|Category missing
237029|NCT01438424|E6|Reported Event|Lamovidine, 100 mg|Participants originally received lamovidine with entecavir
237030|NCT01438424|E5|Reported Event|Entecavir, 1.0 mg|Participants originally received lower doses of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
237031|NCT01438424|E4|Reported Event|Entecavir, 0.5 mg|Participants received entecavir QD with lamovidine
237032|NCT01438424|E3|Reported Event|Entecavir, 0.1 mg|Participants originally received lower doses of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
237033|NCT01438424|E2|Reported Event|Entecavir, 0.02588 mg|Participants originally received lower doses of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
237034|NCT01438424|E1|Reported Event|Adefovir, 10 mg|Participants who received adefovir concomitantly at postdosing follow-up
237035|NCT01438307|B3|Baseline|Total|Total of all reporting groups
237036|NCT01438307|B2|Baseline|Schedule B|Cabazitaxel 8.4 mg/m2 weekly on Days 1, 85, 15, and 22 of a 5 week cycle with a planned dose escalation to 10 mg/m2 weekly if no dose limiting toxicities (DLTs) were observed.
237037|NCT01438307|B1|Baseline|Schedule A|Cabazitaxel 20 mg/m2 every 3 weeks as a 1 hour IV infusion with a planned dose escalation of to 25 mg/m2 if no dose limiting toxicities (DLTs) were observed.
237038|NCT01438307|P2|Participant Flow|Treatment Schedule B|"Cabazitaxel 8.4 mg/m2 weekly on Days 1, 85, 15, and 22 of a 5 week cycle with a planned dose escalation to 10 mg/m2 weekly if no dose limiting toxicities (DLTs) were observed.~All subjects will be followed for survival/progression after every 2 cycles of therapy with imaging studies."
237039|NCT01438307|P1|Participant Flow|Treatment Schedule A|"Cabazitaxel 20 mg/m2 every 3 weeks as a 1 hour IV infusion with a planned dose escalation of to 25 mg/m2 if no dose limiting toxicities (DLTs) were observed.~All subjects will be followed for survival/progression after every 2 cycles of therapy with imaging studies."
237040|NCT01438307|O2|Outcome|Schedule B|"Subjects with advanced NSCLC who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258, different from Schedule A.~Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.~Cabazitaxel-XRP6258 (5-week cycle): Subjects in Schedule B will begin with an initial dose of 8.4 mg/m2 as a 1 hour IV infusion on days 1, 8, 15, and 22 of a 5-week cycle. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 10 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual de"
237342|NCT01437319|P2|Participant Flow|Comfilcon A|Subjects that received comfilcon A lens in Phase II.
237041|NCT01438307|O1|Outcome|Schedule A|"Subjects with advanced non-small cell lung cancer who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258.~Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.~Cabazitaxel-XRP6258 (3-week cycle): Subjects in Schedule A will begin with an initial dose of 20 mg/m2 every 3 weeks as a 1 hour IV infusion. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 25 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual decision from the investigator."
237042|NCT01438307|O2|Outcome|Schedule B|"Subjects with advanced NSCLC who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258, different from Schedule A.~Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.~Cabazitaxel-XRP6258 (5-week cycle): Subjects in Schedule B will begin with an initial dose of 8.4 mg/m2 as a 1 hour IV infusion on days 1, 8, 15, and 22 of a 5-week cycle. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 10 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual de"
237043|NCT01438307|O1|Outcome|Schedule A|"Subjects with advanced non-small cell lung cancer who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258.~Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.~Cabazitaxel-XRP6258 (3-week cycle): Subjects in Schedule A will begin with an initial dose of 20 mg/m2 every 3 weeks as a 1 hour IV infusion. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 25 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual decision from the investigator."
237044|NCT01438307|O2|Outcome|Schedule B|"Subjects with advanced NSCLC who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258, different from Schedule A.~Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.~Cabazitaxel-XRP6258 (5-week cycle): Subjects in Schedule B will begin with an initial dose of 8.4 mg/m2 as a 1 hour IV infusion on days 1, 8, 15, and 22 of a 5-week cycle. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 10 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual de"
237045|NCT01438307|O1|Outcome|Schedule A|"Subjects with advanced non-small cell lung cancer who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258.~Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.~Cabazitaxel-XRP6258 (3-week cycle): Subjects in Schedule A will begin with an initial dose of 20 mg/m2 every 3 weeks as a 1 hour IV infusion. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 25 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual decision from the investigator."
237046|NCT01438307|O2|Outcome|Schedule B|"Subjects with advanced NSCLC who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258, different from Schedule A.~Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.~Cabazitaxel-XRP6258 (5-week cycle): Subjects in Schedule B will begin with an initial dose of 8.4 mg/m2 as a 1 hour IV infusion on days 1, 8, 15, and 22 of a 5-week cycle. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 10 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual de"
237047|NCT01438307|O1|Outcome|Schedule A|"Subjects with advanced non-small cell lung cancer who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258.~Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.~Cabazitaxel-XRP6258 (3-week cycle): Subjects in Schedule A will begin with an initial dose of 20 mg/m2 every 3 weeks as a 1 hour IV infusion. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 25 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual decision from the investigator."
237048|NCT01438307|E2|Reported Event|Treatment Schedule B|"Cabazitaxel 8.4 mg/m2 weekly on Days 1, 85, 15, and 22 of a 5 week cycle with a planned dose escalation to 10 mg/m2 weekly if no dose limiting toxicities (DLTs) were observed.~All subjects will be followed for survival/progression after every 2 cycles of therapy with imaging studies."
237049|NCT01438307|E1|Reported Event|Treatment Schedule A|"Cabazitaxel 20 mg/m2 every 3 weeks as a 1 hour IV infusion with a planned dose escalation of to 25 mg/m2 if no dose limiting toxicities (DLTs) were observed.~All subjects will be followed for survival/progression after every 2 cycles of therapy with imaging studies."
237050|NCT01438294|B3|Baseline|Total|Total of all reporting groups
237051|NCT01438294|B2|Baseline|Video Game|"The training with video game will be done with heart rate monitors with intensity required to achieve 70% of maximum heart rate reached the maximum test for thirty minutes.Will be used Kinect games ( reflex ridge- Adventure).~Video game group: The training with video game will be done with heart rate monitors with intensity required to achieve 70% of maximum heart rate reached the maximum test for thirty minutes.Will be used Kinect games ( adventure- reflex ridge)."
237052|NCT01438294|B1|Baseline|Aerobic Exercise|"The aerobic training will be done on the treadmill with heart monitors with intensity required to achieve 70% of maximum heart rate reached the maximum test for thirty minutes.~Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011)."
237053|NCT01438294|P2|Participant Flow|Video Game|The game “Reflex Ridge” of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA).
237054|NCT01438294|P1|Participant Flow|Aerobic Exercise|Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011).
237055|NCT01438294|O2|Outcome|Video Game|The game “Reflex Ridge” of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA).
237056|NCT01438294|O1|Outcome|Aerobic Exercise|Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011).
237057|NCT01438294|O2|Outcome|Video Game|The game “Reflex Ridge” of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA).
237058|NCT01438294|O1|Outcome|Aerobic Exercise|Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011).
237059|NCT01438294|O2|Outcome|Video Game|The game “Reflex Ridge” of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA).
237060|NCT01438294|O1|Outcome|Aerobic Exercise|Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011).
237061|NCT01438294|E2|Reported Event|Video Game|The game “Reflex Ridge” of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA).
237062|NCT01438294|E1|Reported Event|Aerobic Exercise|Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011).
237063|NCT01438229|B1|Baseline|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237064|NCT01438229|P1|Participant Flow|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237065|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237066|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237067|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237068|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237069|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237070|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237071|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237072|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237073|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237074|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237075|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237076|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237077|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237078|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237079|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237080|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237081|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237082|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237083|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237084|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237085|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237343|NCT01437319|P1|Participant Flow|Lotrafilcon A|All subjects received lotrafilcon A in Phase I.
237086|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237087|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237088|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237089|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237090|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237091|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237092|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237093|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237094|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237095|NCT01438229|E1|Reported Event|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
237096|NCT01438177|B1|Baseline|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.~Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.~Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.~Each cycle is 42 days in length."
237097|NCT01438177|P1|Participant Flow|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.~Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.~Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.~Each cycle is 42 days in length."
237098|NCT01438177|O1|Outcome|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.~Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.~Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.~Each cycle is 42 days in length."
237099|NCT01438177|O1|Outcome|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.~Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.~Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.~Each cycle is 42 days in length."
237100|NCT01438177|O1|Outcome|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.~Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.~Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.~Each cycle is 42 days in length."
237101|NCT01438177|E1|Reported Event|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.~Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.~Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.~Each cycle is 42 days in length."
237102|NCT01438151|B1|Baseline|Remicade|"If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.~Remicade: The first potential for dose augmentation will be at infusion #3. Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved."
237103|NCT01438151|P1|Participant Flow|Remicade|"If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.~Remicade: The first potential for dose augmentation will be at infusion #3. Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved."
237104|NCT01438151|O1|Outcome|Remicade|"If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.~Remicade: The first potential for dose augmentation will be at infusion #3. Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved."
238698|NCT01433250|B2|Baseline|Placebo/AIN457|Placebo for core study and AIN in extension study
237105|NCT01438151|E1|Reported Event|Remicade|"If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.~Remicade: The first potential for dose augmentation will be at infusion #3. Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved."
237106|NCT01438060|B3|Baseline|Total|Total of all reporting groups
237107|NCT01438060|B2|Baseline|Aripiprazole|Acute Phase: Dosed at 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237108|NCT01438060|B1|Baseline|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks)
237109|NCT01438060|P2|Participant Flow|Aripiprazole|Acute Phase: Dosed at 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237110|NCT01438060|P1|Participant Flow|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks)
237111|NCT01438060|O1|Outcome|Aripiprazole|Treatment beyond 140 weeks: Dosed at 2-15 mg/day (flexible dosing).
237112|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
237113|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
237114|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
237115|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
237116|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
237117|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
237118|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
237119|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
237120|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
237121|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
237122|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237123|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237124|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: Dosed at 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237125|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks)
237126|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237127|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237128|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237129|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237130|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237131|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237132|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237133|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237134|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237135|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237136|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237137|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237138|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237139|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237140|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237141|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237142|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237143|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237144|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237145|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237146|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237147|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237148|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237149|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237150|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237151|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237152|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237154|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237155|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237156|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237157|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237158|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237159|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237160|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237161|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237162|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237163|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237164|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237165|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237166|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237167|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237168|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237169|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237170|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237171|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237172|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237173|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237174|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237175|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237176|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237177|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237178|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237179|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237180|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237181|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237182|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
237183|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
237184|NCT01438060|E3|Reported Event|3 Ext - Aripiprazole|
237185|NCT01438060|E2|Reported Event|2 Double Blind Placebo|
237186|NCT01438060|E1|Reported Event|1 Double Blind Aripiprazole|
237187|NCT01437995|B4|Baseline|Total|Total of all reporting groups
237188|NCT01437995|B3|Baseline|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol~Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
237189|NCT01437995|B2|Baseline|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily~Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
237190|NCT01437995|B1|Baseline|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily~Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
237191|NCT01437995|P3|Participant Flow|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol~Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
237192|NCT01437995|P2|Participant Flow|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily~Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
237193|NCT01437995|P1|Participant Flow|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily~Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
237194|NCT01437995|O3|Outcome|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol~Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
237195|NCT01437995|O2|Outcome|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily~Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
237196|NCT01437995|O1|Outcome|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily~Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
237197|NCT01437995|O3|Outcome|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol~Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
237198|NCT01437995|O2|Outcome|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily~Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
237199|NCT01437995|O1|Outcome|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily~Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
237200|NCT01437995|O3|Outcome|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol~Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
237201|NCT01437995|O2|Outcome|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily~Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
238699|NCT01433250|B1|Baseline|AIN457/ AIN457|AIN in core study , continued AIN in extension study
237202|NCT01437995|O1|Outcome|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily~Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
237203|NCT01437995|O3|Outcome|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol~Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
237204|NCT01437995|O2|Outcome|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily~Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
237205|NCT01437995|O1|Outcome|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily~Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
237206|NCT01437995|O3|Outcome|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol~Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
237207|NCT01437995|O2|Outcome|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily~Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
237208|NCT01437995|O1|Outcome|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily~Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
237209|NCT01437995|E3|Reported Event|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol~Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
237210|NCT01437995|E2|Reported Event|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily~Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
237211|NCT01437995|E1|Reported Event|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily~Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
237212|NCT01437943|B3|Baseline|Total|Total of all reporting groups
237213|NCT01437943|B2|Baseline|Placebo|"Placebo daily for 180 days~Placebo: Take 1 tablet (0 mg) daily for 180 days"
237214|NCT01437943|B1|Baseline|Aliskiren|"Aliskiren 150 mg daily for 180 days~Aliskiren: Take 1 tablet (150 mg) by mouth daily for 180 days"
237215|NCT01437943|P2|Participant Flow|Placebo|"Placebo daily for 180 days~Placebo: Take 1 tablet by mouth daily for 180 days"
237216|NCT01437943|P1|Participant Flow|Aliskiren|"Aliskiren 150 mg daily for 180 days~Aliskiren: Take 1 tablet (150 mg) by mouth daily for 180 days"
237217|NCT01437943|O2|Outcome|Placebo|"Placebo identical to Aliskiren drug daily for 180 days~Placebo: Take 1 tablet (0 mg) daily for 180 days."
237218|NCT01437943|O1|Outcome|Aliskiren|"Aliskiren 150 mg daily for 180 days~Aliskiren: Take 1 tablet (150 mg) by mouth daily for 180 days"
237219|NCT01437943|E2|Reported Event|Placebo|"Placebo daily for 180 days~Placebo: Take 1 tablet by mouth daily for 180 days"
237220|NCT01437943|E1|Reported Event|Aliskiren|"Aliskiren 150 mg daily for 180 days~Aliskiren: Take 1 tablet (150 mg) by mouth daily for 180 days"
237221|NCT01437878|B3|Baseline|Total|Total of all reporting groups
237222|NCT01437878|B2|Baseline|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
237223|NCT01437878|B1|Baseline|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
237224|NCT01437878|P2|Participant Flow|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
237225|NCT01437878|P1|Participant Flow|Iloprost|"single dose inhalation using the power disc-6 with I-neb Adaptive Aerosol Delivery (AAD) system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
237226|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
237227|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
237228|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
237229|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
237230|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
237231|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
237232|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
237233|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
237234|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
237235|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
237236|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
237237|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
237238|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
237239|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
237240|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
237241|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
237242|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
238758|NCT01433081|O2|Outcome|Placebo|.9 normal saline infusion
237243|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
237244|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
237245|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
237246|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
237247|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
237248|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
237249|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
237250|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
237251|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
237252|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
237253|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
237254|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
237255|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
237256|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
237257|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
237258|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
237259|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
237260|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
237261|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
237262|NCT01437878|E2|Reported Event|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
237263|NCT01437878|E1|Reported Event|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
237264|NCT01437540|B3|Baseline|Total|Total of all reporting groups
237265|NCT01437540|B2|Baseline|Formoterol 12 μg|Formoterol 12 μg administered BID via dry-powder inhaler
237266|NCT01437540|B1|Baseline|Aclidinium/Formoterol 400 μg/12 μg|Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
237267|NCT01437540|P2|Participant Flow|Formoterol 12 μg|Formoterol 12 μg administered BID via dry-powder inhaler
237268|NCT01437540|P1|Participant Flow|Aclidinium/Formoterol 400 μg/12 μg|Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
237269|NCT01437540|O2|Outcome|Formoterol 12 μg|Formoterol 12 μg administered BID via dry-powder inhaler
237270|NCT01437540|O1|Outcome|Aclidinium/Formoterol 400 μg/12 μg|Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
237271|NCT01437540|O2|Outcome|Formoterol 12 μg|Formoterol 12 μg administered BID via dry-powder inhaler
237272|NCT01437540|O1|Outcome|Aclidinium/Formoterol 400 μg/12 μg|Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
237273|NCT01437540|O2|Outcome|Formoterol 12 μg|Formoterol 12 μg administered BID via dry-powder inhaler
237274|NCT01437540|O1|Outcome|Aclidinium/Formoterol 400 μg/12 μg|Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
237275|NCT01437540|O2|Outcome|Formoterol 12 μg|Formoterol 12 μg administered BID via dry-powder inhaler
237276|NCT01437540|O1|Outcome|Aclidinium/Formoterol 400 μg/12 μg|Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
237277|NCT01437540|E2|Reported Event|Formoterol 12 μg|Formoterol 12 μg administered BID via dry-powder inhaler
237278|NCT01437540|E1|Reported Event|Aclidinium/Formoterol 400 μg/12 μg|Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
237279|NCT01437501|B3|Baseline|Total|Total of all reporting groups
237280|NCT01437501|B2|Baseline|Placebo Beverage|placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
237281|NCT01437501|B1|Baseline|Broccoli Sprout Extract Beverage|Broccoli Sprout Extract Beverage : Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
237282|NCT01437501|P2|Participant Flow|Placebo Beverage|placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
237283|NCT01437501|P1|Participant Flow|Broccoli Sprout Extract Beverage|Broccoli Sprout Extract Beverage : Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
237284|NCT01437501|O2|Outcome|Broccoli Sprout Extract Beverage|Broccoli Sprout Extract Beverage: Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
237285|NCT01437501|O1|Outcome|Placebo Beverage|placebo beverage: 100 mL of dilute pineapple and lime juice daily for 84 days.
238759|NCT01433081|O1|Outcome|Magnesium Sulfate Infusion|Administration of magnesium suflate
237286|NCT01437501|O2|Outcome|Placebo Beverage|placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
237287|NCT01437501|O1|Outcome|Broccoli Sprout Extract Beverage|Broccoli Sprout Extract Beverage : Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
237288|NCT01437501|E2|Reported Event|Placebo Beverage|placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
237289|NCT01437501|E1|Reported Event|Broccoli Sprout Extract Beverage|Broccoli Sprout Extract Beverage : Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
237290|NCT01437488|B1|Baseline|Cabazitaxel|"Cabazitaxel following platinum-based chemotherapy~Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days~Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion~Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator~Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks) Blood Draw: Approximately 2 tablespoons of blood will be taken to test complete blood count, glucose, hematology, electrolytes, liver function, creatinine clearance, and a chemistry profile. This week be done weekly durin"
237291|NCT01437488|P1|Participant Flow|Cabazitaxel|"Cabazitaxel following platinum-based chemotherapy Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days~Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion~Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator~Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days~CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks)~Blood Draw: Approximately 2 tablespoons of blood will be taken to test complete blood count, glucose, hematology, electrolytes, liver function, creatinine clearance, and a chemistry profile. This week be done weekly durin"
237292|NCT01437488|O1|Outcome|Cabazitaxel|"Cabazitaxel following platinum-based chemotherapy~Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days~Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion~Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator~Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days~CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks)~Blood Draw: Approximately 2 tablespoons of blood will be taken to test complete blood count, glucose, hematology, electrolytes, liver function, creatinine clearance, and a chemistry profile."
237293|NCT01437488|O1|Outcome|Cabazitaxel|"Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days~Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion~Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator~Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days~CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks)~Blood Draw: Approximately 2 tablespoons of blood will be taken to test complete blood count, glucose, hematology, electrolytes, liver function, creatinine clearance, and a chemistry profile. This week be done weekly during the first cycle of treatment"
237294|NCT01437488|O1|Outcome|Cabazitaxel|"Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days~Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion~Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks) Blood Draw: Approximately 2 tablespoons of blood will be taken to test complete blood count, glucose, hematology, electrolytes, liver function, creatinine clearance, and a chemistry profile. This week be done weekly during the first cycle of treatment"
237295|NCT01437488|O1|Outcome|Cabazitaxel|"Cabazitaxel following platinum-based chemotherapy Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days~Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion~Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator~Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days~CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks)~Blood Draw: Approximately 2 tablespoons of blood will be taken to test complete blood count, glucose, hematology, electrolytes, liver function, creatinine clearance, and a chemistry profile. This week be done weekly durin"
237344|NCT01437319|O2|Outcome|Non-repeat Mucin Ball Former|Subjects that were classified as Non-repeat Mucin Ball Former
237345|NCT01437319|O1|Outcome|Repeat Mucin Ball Former|Subjects that were classified as being repeat Mucin Ball former
237346|NCT01437319|O2|Outcome|Non-repeat Mucin Ball Former|Subjects that were classified as Non-repeat Mucin Ball Former.
237347|NCT01437319|O1|Outcome|Repeat Mucin Ball Former|Subjects that were classified as being repeat Mucin Ball former.
237348|NCT01437319|E3|Reported Event|Lotrafilcon A|All Subjects received lotrafilcon A in Phase I of the study.
237349|NCT01437319|E2|Reported Event|Balafilcon A|Subjects who received balafilcon A in Phase II of the study
237296|NCT01437488|E1|Reported Event|Cabazitaxel|"Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days~Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion~Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator~Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days~CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks)~Blood Draw: Approximately 2 tablespoons of blood will be taken to test complete blood count, glucose, hematology, electrolytes, liver function, creatinine clearance, and a chemistry profile. This week be done weekly during the first cycle of treatment"
237297|NCT01437423|B1|Baseline|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
237298|NCT01437423|P1|Participant Flow|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
237299|NCT01437423|O1|Outcome|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
237300|NCT01437423|O1|Outcome|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
237301|NCT01437423|O1|Outcome|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
237302|NCT01437423|O1|Outcome|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
237303|NCT01437423|E1|Reported Event|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
237304|NCT01437397|B6|Baseline|Total|Total of all reporting groups
237305|NCT01437397|B5|Baseline|Placebo|Administered BID by inhalation
237306|NCT01437397|B4|Baseline|Formoterol 12 μg|Administered BID by inhalation
237307|NCT01437397|B3|Baseline|Aclidinium 400 μg|Administered BID by inhalation
237308|NCT01437397|B2|Baseline|Aclidinium/Formoterol 400/6 μg|Fixed-dose combination (FDC) administered BID by inhalation
237309|NCT01437397|B1|Baseline|Aclidinium/Formoterol 400/12 μg|Fixed-dose combination (FDC) administered BID by inhalation
237310|NCT01437397|P5|Participant Flow|Placebo|Administered BID by inhalation
237311|NCT01437397|P4|Participant Flow|Formoterol 12 μg|Administered BID by inhalation
237312|NCT01437397|P3|Participant Flow|Aclidinium 400 μg|Administered BID by inhalation
237313|NCT01437397|P2|Participant Flow|Aclidinium/Formoterol 400/6 μg|Fixed-dose combination (FDC) administered BID by inhalation
237314|NCT01437397|P1|Participant Flow|Aclidinium/Formoterol 400/12 μg|Fixed-dose combination (FDC) administered BID by inhalation
237315|NCT01437397|O5|Outcome|Placebo|Administered BID by inhalation
237316|NCT01437397|O4|Outcome|Formoterol 12 μg|Administered BID by inhalation
237317|NCT01437397|O3|Outcome|Aclidinium 400 μg|Administered BID by inhalation
237318|NCT01437397|O2|Outcome|Aclidinium/Formoterol 400/6 μg|Fixed-dose combination (FDC) administered BID by inhalation
237319|NCT01437397|O1|Outcome|Aclidinium/Formoterol 400/12 μg|Fixed-dose combination (FDC) administered BID by inhalation
237320|NCT01437397|O5|Outcome|Placebo|Administered BID by inhalation
237321|NCT01437397|O4|Outcome|Formoterol 12 μg|Administered BID by inhalation
237322|NCT01437397|O3|Outcome|Aclidinium 400 μg|Administered BID by inhalation
237323|NCT01437397|O2|Outcome|Aclidinium/Formoterol 400/6 μg|Fixed-dose combination (FDC) administered BID by inhalation
237324|NCT01437397|O1|Outcome|Aclidinium/Formoterol 400/12 μg|Fixed-dose combination (FDC) administered BID by inhalation
237325|NCT01437397|O5|Outcome|Placebo|Administered BID by inhalation
237326|NCT01437397|O4|Outcome|Formoterol 12 μg|Administered BID by inhalation
237327|NCT01437397|O3|Outcome|Aclidinium 400 μg|Administered BID by inhalation
237328|NCT01437397|O2|Outcome|Aclidinium/Formoterol 400/6 μg|Fixed-dose combination (FDC) administered BID by inhalation
237329|NCT01437397|O1|Outcome|Aclidinium/Formoterol 400/12 μg|Fixed-dose combination (FDC) administered BID by inhalation
237330|NCT01437397|O5|Outcome|Placebo|Administered BID by inhalation
237331|NCT01437397|O4|Outcome|Formoterol 12 μg|Administered BID by inhalation
237332|NCT01437397|O3|Outcome|Aclidinium 400 μg|Administered BID by inhalation
237333|NCT01437397|O2|Outcome|Aclidinium/Formoterol 400/6 μg|Fixed-dose combination (FDC) administered BID by inhalation
237334|NCT01437397|O1|Outcome|Aclidinium/Formoterol 400/12 μg|Fixed-dose combination (FDC) administered BID by inhalation
237335|NCT01437397|E5|Reported Event|Placebo|Administered BID by inhalation
237336|NCT01437397|E4|Reported Event|Formoterol 12 μg|Administered BID by inhalation
237337|NCT01437397|E3|Reported Event|Aclidinium 400 μg|Administered BID by inhalation
237338|NCT01437397|E2|Reported Event|Aclidinium/Formoterol 400/6 μg|Fixed-dose combination (FDC) administered BID by inhalation
237339|NCT01437397|E1|Reported Event|Aclidinium/Formoterol 400/12 μg|Fixed-dose combination (FDC) administered BID by inhalation
237340|NCT01437319|B1|Baseline|Overall|The analysis population consists of all subjects that were enrolled into the study.
237341|NCT01437319|P3|Participant Flow|Balfilcon A|Subjects that received balafilcon A lens in Phase II.
237350|NCT01437319|E1|Reported Event|Comfilcon A|Subjects who received comfilcon A in Phase II of the study.
237351|NCT01437267|B7|Baseline|Total|Total of all reporting groups
237352|NCT01437267|B6|Baseline|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
237353|NCT01437267|B5|Baseline|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
237354|NCT01437267|B4|Baseline|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
237355|NCT01437267|B3|Baseline|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
237356|NCT01437267|B2|Baseline|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
237357|NCT01437267|B1|Baseline|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
237358|NCT01437267|P6|Participant Flow|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
237359|NCT01437267|P5|Participant Flow|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
237360|NCT01437267|P4|Participant Flow|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
237361|NCT01437267|P3|Participant Flow|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
237362|NCT01437267|P2|Participant Flow|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
237363|NCT01437267|P1|Participant Flow|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
237364|NCT01437267|O6|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
237365|NCT01437267|O5|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
237366|NCT01437267|O4|Outcome|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
237367|NCT01437267|O3|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
237368|NCT01437267|O2|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
237369|NCT01437267|O1|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
237370|NCT01437267|O6|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
237371|NCT01437267|O5|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
237372|NCT01437267|O4|Outcome|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
237373|NCT01437267|O3|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
237374|NCT01437267|O2|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
237375|NCT01437267|O1|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
237376|NCT01437267|O6|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
237377|NCT01437267|O5|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
237378|NCT01437267|O4|Outcome|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
237379|NCT01437267|O3|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
237380|NCT01437267|O2|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
237381|NCT01437267|O1|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
237382|NCT01437267|O6|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
237383|NCT01437267|O5|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
237384|NCT01437267|O4|Outcome|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
237385|NCT01437267|O3|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
237386|NCT01437267|O2|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
237387|NCT01437267|O1|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
237388|NCT01437267|O6|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
237389|NCT01437267|O5|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
237390|NCT01437267|O4|Outcome|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
237391|NCT01437267|O3|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
237392|NCT01437267|O2|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
237393|NCT01437267|O1|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
237394|NCT01437267|E6|Reported Event|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
237395|NCT01437267|E5|Reported Event|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
237396|NCT01437267|E4|Reported Event|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
237397|NCT01437267|E3|Reported Event|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
237398|NCT01437267|E2|Reported Event|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
237399|NCT01437267|E1|Reported Event|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
237400|NCT01437124|B1|Baseline|Ceramic on Metal THA|Those who have received a ceramic on metal total hip replacement
237401|NCT01437124|P1|Participant Flow|Ceramic on Metal THA|Those who have received a ceramic on metal total hip replacement
237402|NCT01437124|O1|Outcome|Ceramic on Metal THA|Those who have received a ceramic on metal total hip replacement
237403|NCT01437124|O1|Outcome|Ceramic on Metal THA|Those who have received a ceramic on metal total hip replacement
237404|NCT01437124|E1|Reported Event|Ceramic on Metal THA|Those who have received a ceramic on metal total hip replacement
237405|NCT01437111|B1|Baseline|Fosamax Plus: All Treated Participants|All participants who received at least one oral dose combination tablet of Fosamax Plus.
237406|NCT01437111|P1|Participant Flow|Fosamax Plus: All Participants|All participants who were enrolled in the study to receive one oral combination tablet of Fosamax Plus weekly.
237407|NCT01437111|O4|Outcome|Fosamax Plus: All Treated Participants|All participants who received at least one oral dose combination tablet of Fosamax Plus.
237408|NCT01437111|O3|Outcome|Fosamax Plus: Treatment Naive at Baseline|Participants that were treatment-naïve or not recently treated at baseline were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
237409|NCT01437111|O2|Outcome|Fosamax Plus: Other Osteoporosis Therapy at Baseline|Participants receiving other osteoporosis drugs at baseline (besides bisphosphonate, strontium, estrogen, or SERM) were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
237410|NCT01437111|O1|Outcome|Fosamax Plus: Recent/Current Osteoporosis Therapy at Baseline|Participants receiving recent/current osteoporosis therapy at baseline (including bisphosphonate, strontium, estrogen, or SERM were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
237411|NCT01437111|O4|Outcome|Fosamax Plus: All Treated Participants|All participants who received at least one oral dose combination tablet of Fosamax Plus.
237412|NCT01437111|O3|Outcome|Fosamax Plus: Treatment Naive at Baseline|Participants that were treatment-naïve or not recently treated at baseline were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
237413|NCT01437111|O2|Outcome|Fosamax Plus: Other Osteoporosis Therapy at Baseline|Participants receiving other osteoporosis drugs at baseline (besides bisphosphonate, strontium, estrogen, or SERM) were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
237414|NCT01437111|O1|Outcome|Fosamax Plus: Recent/Current Osteoporosis Therapy at Baseline|Participants receiving recent/current osteoporosis therapy at baseline (including bisphosphonate, strontium, estrogen, or SERM were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
237415|NCT01437111|E1|Reported Event|Fosamax Plus: All Treated Participants|All participants who received at least one oral dose combination tablet of Fosamax Plus.
237416|NCT01437098|B1|Baseline|MDT-2111 TAVI|Transcatheter Aortic Valve Implantation (TAVI) with MDT-2111 system.
237417|NCT01437098|P1|Participant Flow|MDT-2111 TAVI|Transcatheter Aortic Valve Implantation (TAVI) with MDT-2111 system.
237418|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237419|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237420|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237421|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237422|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237423|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
237424|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
237425|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
237426|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
237427|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
237428|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
237429|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
237488|NCT01436643|O4|Outcome|Fingolimod|2 Week Pre-treatment Period: Fingolimod 0.5 mg per capsule (hard gelatin capsules) was taken p.o. once during 2 week pre-treatment period.
238760|NCT01433081|O2|Outcome|Placebo|Normal saline infusion
237430|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
237431|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
237432|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
237433|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237434|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237435|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237436|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237437|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237438|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237439|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237440|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237441|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237442|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237443|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237444|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237445|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237446|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237447|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237448|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237449|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237450|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237451|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237452|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237453|NCT01437098|O1|Outcome|As Treated Population With Index Procedure|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed. Index procedure was defined as introduction of the MDT-2111 TAV system delivery catheter.
237454|NCT01437098|O1|Outcome|As Treated Population With Index Procedure|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed. Index procedure was defined as introduction of the MDT-2111 TAV system delivery catheter.
237455|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed..
237456|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed..
237457|NCT01437098|O1|Outcome|As Treated (AT) Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
237489|NCT01436643|O3|Outcome|Citalopram and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg
237458|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
237459|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
237460|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237461|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237462|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237463|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237464|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237465|NCT01437098|O2|Outcome|Iliofemoral Implanted Subjects|The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237466|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
237467|NCT01437098|E4|Reported Event|All Subjects (As Treated Subjects)|This includes subjects from all access approaches, iliofemoral, subclavian and direct aortic.
237468|NCT01437098|E3|Reported Event|Direct Aortic (As Treated Subjects)|For patients who would benefit from the therapy but have unfavorable non-aortic vasculature of the transfemoral and subclavian/axillary access sites (i.e. excessive atherosclerosis, calcifications, or tortuosity of arteries), the direct aortic approach is currently being used in oversea(EU and US) in clinical practice with similar outcomes to transfemoral and subclavian/ axillary artery approaches.
237469|NCT01437098|E2|Reported Event|Subclavian (As Treated Subjects)|The subclavian access is additionally chosen (as the secondary access site) when physicians may require an alternative to the femoral access site for patients who would benefit from the therapy but have unfavorable peripheral vasculature such as excessive atherosclerosis, calcifications, or tortuosity of common femoral arteries.
237470|NCT01437098|E1|Reported Event|Iliofemoral (As Treated Subjects)|The iliofemoral approach is used as the primary access site because there is a large body of clinical data in the past using this approach in patients.
237471|NCT01436799|B3|Baseline|Total|Total of all reporting groups
237472|NCT01436799|B2|Baseline|Propofol|anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1, alfentanil 10 μg kg-1, and rocuronium 0.6 mg kg-1. A commercially available target controlled infusion (TCI) pump (Orchestra®, Fresenius Vial, France) was used and the pharmacokinetic set used to calculate target effect-site concentrations for propofol was Schnider and colleagues' model
237473|NCT01436799|B1|Baseline|Desflurane|anaesthesia was induced with thiopental sodium 2 mg kg-1, alfentanil 10 μg kg-1 and rocuronium 0.6 mg kg-1. Anesthetic maintenance by desflurane
237474|NCT01436799|P2|Participant Flow|Propofol|anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1, alfentanil 10 μg kg-1, and rocuronium 0.6 mg kg-1. A commercially available target controlled infusion (TCI) pump (Orchestra®, Fresenius Vial, France) was used and the pharmacokinetic set used to calculate target effect-site concentrations for propofol was Schnider and colleagues' model
237475|NCT01436799|P1|Participant Flow|Desflurane|anaesthesia was induced with thiopental sodium 2 mg kg-1, alfentanil 10 μg kg-1 and rocuronium 0.6 mg kg-1. Anesthetic maintenance by desflurane
237476|NCT01436799|O2|Outcome|Propofol|anesthetic maintanence with propofol
237477|NCT01436799|O1|Outcome|Desflurane|anesthetic maintenence with desflurane
237478|NCT01436799|E2|Reported Event|Propofol|anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1, alfentanil 10 μg kg-1, and rocuronium 0.6 mg kg-1. A commercially available target controlled infusion (TCI) pump (Orchestra®, Fresenius Vial, France) was used and the pharmacokinetic set used to calculate target effect-site concentrations for propofol was Schnider and colleagues' model
237479|NCT01436799|E1|Reported Event|Desflurane|anaesthesia was induced with thiopental sodium 2 mg kg-1, alfentanil 10 μg kg-1 and rocuronium 0.6 mg kg-1. Anesthetic maintenance by desflurane
237480|NCT01436643|B4|Baseline|Total|Total of all reporting groups
237481|NCT01436643|B3|Baseline|Citalopram and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg
237482|NCT01436643|B2|Baseline|Venlafaxine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg
237483|NCT01436643|B1|Baseline|Fluoxetine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg
237484|NCT01436643|P4|Participant Flow|Pre-treatment With Fingolimod|During 2weeks pre-treatment period patients received Fingolimod 0.5 mg per capsule (hard gelatin capsules) orally once daily.
237485|NCT01436643|P3|Participant Flow|Citalopram and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg
237486|NCT01436643|P2|Participant Flow|Venlafaxine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg
237487|NCT01436643|P1|Participant Flow|Fluoxetine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg
237490|NCT01436643|O2|Outcome|Venlafaxine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg
237491|NCT01436643|O1|Outcome|Fluoxetine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg
237492|NCT01436643|E4|Reported Event|Fluoxetine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg
237493|NCT01436643|E3|Reported Event|Citalopram and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg
237494|NCT01436643|E2|Reported Event|Venlafaxine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg
237495|NCT01436643|E1|Reported Event|Fingolimod|2 Week Pre-treatment Period: Fingolimod 0.5 mg per capsule (hard gelatin capsules) was taken p.o. once during 2 week pre-treatment period.
237496|NCT01436526|B3|Baseline|Total|Total of all reporting groups
237497|NCT01436526|B2|Baseline|Rivaroxaban (Xarelto, BAY59-7939) First 1*10 mg, Then 2*5 mg|Single oral dose of rivaroxaban administered under fasting conditions 1*10 mg tablet in first intervention period and 2*5 mg tablet in second intervention period (after washout period)
237498|NCT01436526|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939) First 2*5 mg , Then 1*10 mg|Single oral dose of rivaroxaban administered under fasting conditions 2*5 mg tablet in first intervention period and 1*10 mg tablet in second intervention period (after washout period)
237499|NCT01436526|P2|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939) First 1*10 mg, Then 2*5 mg|Single oral dose of rivaroxaban administered under fasting conditions 1*10 mg tablet in first intervention period and 2*5 mg tablet in second intervention period (after washout period)
237500|NCT01436526|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939) First 2*5 mg, Then 1*10 mg|Single oral dose of rivaroxaban administered under fasting conditions 2*5 mg tablet in first intervention period and 1*10 mg tablet in second intervention period (after washout period)
237501|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
237502|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
237503|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
237504|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
237505|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
237506|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
237507|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
237508|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
237509|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
237510|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
237511|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
237512|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
237513|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
237514|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
237515|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
237516|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
237517|NCT01436526|E2|Reported Event|Rivaroxaban 1*10 mg (Xarelto, BAY59-7939)|Single oral dose of 1*10 mg rivaroxaban tablet administered under fasting conditions
237518|NCT01436526|E1|Reported Event|Rivaroxaban 2*5 mg (Xarelto, BAY59-7939)|Single oral dose of 2*5 mg rivaroxaban tablets administered under fasting conditions
237519|NCT01436500|B3|Baseline|Total|Total of all reporting groups
237520|NCT01436500|B2|Baseline|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
237521|NCT01436500|B1|Baseline|Ifetroban Injection|5, 15, 50, or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
237522|NCT01436500|P5|Participant Flow|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
237523|NCT01436500|P4|Participant Flow|150 mg Ifetroban|150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
237524|NCT01436500|P3|Participant Flow|50 mg Ifetroban|50 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
237525|NCT01436500|P2|Participant Flow|15 mg Ifetroban|15 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
237526|NCT01436500|P1|Participant Flow|5 mg Ifetroban|5 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
237527|NCT01436500|O2|Outcome|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
237528|NCT01436500|O1|Outcome|Ifetroban Injection|5, 15, 50, or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
237529|NCT01436500|O2|Outcome|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
237530|NCT01436500|O1|Outcome|Ifetroban Injection|5, 15, 50, or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
237531|NCT01436500|O2|Outcome|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
237532|NCT01436500|O1|Outcome|Ifetroban Injection|5, 15, 50, or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
237533|NCT01436500|O2|Outcome|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
237534|NCT01436500|O1|Outcome|Ifetroban Injection|5, 15, 50, or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
237535|NCT01436500|O7|Outcome|150 mg Ifetroban, Type 2|"60-minute intravenous infusion of 150 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
237536|NCT01436500|O6|Outcome|50 mg Ifetroban, Type 2|"60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
237537|NCT01436500|O5|Outcome|50 mg Ifetroban, Type 1|"60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
237538|NCT01436500|O4|Outcome|15 mg Ifetroban, Type 2|"60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
237539|NCT01436500|O3|Outcome|15 mg Ifetroban, Type 1|"60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
237540|NCT01436500|O2|Outcome|5 mg Ifetroban, Type 2|"60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
237541|NCT01436500|O1|Outcome|5 mg Ifetroban, Type 1|"60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
237542|NCT01436500|O7|Outcome|150 mg Ifetroban, Type 2|"60-minute intravenous infusion of 150 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
237543|NCT01436500|O6|Outcome|50 mg Ifetroban, Type 2|"60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
237544|NCT01436500|O5|Outcome|50 mg Ifetroban, Type 1|"60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
237545|NCT01436500|O4|Outcome|15 mg Ifetroban, Type 2|"60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
237546|NCT01436500|O3|Outcome|15 mg Ifetroban, Type 1|"60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
237547|NCT01436500|O2|Outcome|5 mg Ifetroban, Type 2|"60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
237548|NCT01436500|O1|Outcome|5 mg Ifetroban, Type 1|"60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
237549|NCT01436500|O7|Outcome|150 mg Ifetroban, Type 2|"60-minute intravenous infusion of 150 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
237550|NCT01436500|O6|Outcome|50 mg Ifetroban, Type 2|"60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
237551|NCT01436500|O5|Outcome|50 mg Ifetroban, Type 1|"60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
237552|NCT01436500|O4|Outcome|15 mg Ifetroban, Type 2|"60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
237553|NCT01436500|O3|Outcome|15 mg Ifetroban, Type 1|"60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
237554|NCT01436500|O2|Outcome|5 mg Ifetroban, Type 2|"60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
237555|NCT01436500|O1|Outcome|5 mg Ifetroban, Type 1|"60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
237556|NCT01436500|E2|Reported Event|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
237557|NCT01436500|E1|Reported Event|Ifetroban|5, 15, 50 or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
237558|NCT01436435|B1|Baseline|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
237559|NCT01436435|P1|Participant Flow|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
237560|NCT01436435|O1|Outcome|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
237622|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
237561|NCT01436435|O1|Outcome|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
237562|NCT01436435|O1|Outcome|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
237563|NCT01436435|O1|Outcome|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
237564|NCT01436435|O1|Outcome|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
237565|NCT01436435|O1|Outcome|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
237566|NCT01436435|E1|Reported Event|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
237567|NCT01436370|B9|Baseline|Total|Total of all reporting groups
237568|NCT01436370|B8|Baseline|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
237569|NCT01436370|B7|Baseline|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
237570|NCT01436370|B6|Baseline|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
237571|NCT01436370|B5|Baseline|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
237572|NCT01436370|B4|Baseline|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
237573|NCT01436370|B3|Baseline|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
237574|NCT01436370|B2|Baseline|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
237575|NCT01436370|B1|Baseline|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
237576|NCT01436370|P8|Participant Flow|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
237577|NCT01436370|P7|Participant Flow|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
237578|NCT01436370|P6|Participant Flow|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
237579|NCT01436370|P5|Participant Flow|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
237580|NCT01436370|P4|Participant Flow|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
237581|NCT01436370|P3|Participant Flow|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
237582|NCT01436370|P2|Participant Flow|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
237583|NCT01436370|P1|Participant Flow|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
237584|NCT01436370|O4|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
237585|NCT01436370|O3|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
237586|NCT01436370|O2|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
237587|NCT01436370|O1|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
237588|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
237589|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
237590|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
238282|NCT01435122|O1|Outcome|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
237591|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
237592|NCT01436370|O4|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
237593|NCT01436370|O3|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
237594|NCT01436370|O2|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
237595|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
237596|NCT01436370|O2|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
237597|NCT01436370|O1|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
237598|NCT01436370|O2|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
237599|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
237600|NCT01436370|O2|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
237601|NCT01436370|O1|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
237602|NCT01436370|O8|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
237603|NCT01436370|O7|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
237604|NCT01436370|O6|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
237605|NCT01436370|O5|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
237606|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
237607|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
237608|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
237609|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
237610|NCT01436370|O8|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
237611|NCT01436370|O7|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
237612|NCT01436370|O6|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
237613|NCT01436370|O5|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
237614|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
237615|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
237616|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
237617|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
237618|NCT01436370|O8|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
237619|NCT01436370|O7|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
237620|NCT01436370|O6|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
237621|NCT01436370|O5|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
238761|NCT01433081|O1|Outcome|Magnesium Sulfate Infusion|Administration of magnesium suflate
237623|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
237624|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
237625|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
237626|NCT01436370|O8|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
237627|NCT01436370|O7|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
237628|NCT01436370|O6|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
237629|NCT01436370|O5|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
237630|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
237631|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
237632|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
237633|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
237634|NCT01436370|O4|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
237635|NCT01436370|O3|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
237636|NCT01436370|O2|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
237637|NCT01436370|O1|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
237638|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
237639|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
237640|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
237641|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
237642|NCT01436370|O8|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
237643|NCT01436370|O7|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
237644|NCT01436370|O6|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
237645|NCT01436370|O5|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
237646|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
237647|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
237648|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
237649|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
237650|NCT01436370|O2|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
237651|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
237652|NCT01436370|E8|Reported Event|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
237653|NCT01436370|E7|Reported Event|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
237654|NCT01436370|E6|Reported Event|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
237655|NCT01436370|E5|Reported Event|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
237656|NCT01436370|E4|Reported Event|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
237657|NCT01436370|E3|Reported Event|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
237658|NCT01436370|E2|Reported Event|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
237659|NCT01436370|E1|Reported Event|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
237660|NCT01436305|B4|Baseline|Total|Total of all reporting groups
237661|NCT01436305|B3|Baseline|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237662|NCT01436305|B2|Baseline|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237663|NCT01436305|B1|Baseline|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237664|NCT01436305|P3|Participant Flow|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237665|NCT01436305|P2|Participant Flow|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237666|NCT01436305|P1|Participant Flow|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237775|NCT01436279|O2|Outcome|Osmotic Dilators|"Placed 20-24 hours prior to procedure~osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure"
237776|NCT01436279|O1|Outcome|Mifepristone + Misoprostol|"Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure~Mifepristone: 200 mg po 20-24 hours prior to the procedure"
238424|NCT01434680|B1|Baseline|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
237667|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237668|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237669|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237670|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237671|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237672|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237673|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237674|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237675|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237676|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237677|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237678|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237679|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237680|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237681|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237690|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237682|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237683|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237684|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237685|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237686|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237687|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237688|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237689|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237691|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237692|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237693|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237694|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237695|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237696|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237697|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237698|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237699|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237700|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237701|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237702|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237703|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237704|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237705|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237714|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237706|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237707|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237708|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237709|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237710|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237711|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237712|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237713|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237715|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237716|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237717|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237718|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237719|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237720|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237721|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237722|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237723|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237724|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237725|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237726|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237727|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237728|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237729|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237738|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237730|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237731|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237732|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237733|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237734|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237735|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237736|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237737|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237739|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237740|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237741|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237742|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237743|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237744|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237745|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237746|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237747|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237748|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237749|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237750|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237751|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237752|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237753|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237770|NCT01436279|O1|Outcome|Mifepristone + Misoprostol|"Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure~Mifepristone: 200 mg po 20-24 hours prior to the procedure"
237771|NCT01436279|O2|Outcome|Osmotic Dilators|Placed 20-24 hours prior to procedure
237772|NCT01436279|O1|Outcome|Mifepristone + Misoprostol|Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure
237773|NCT01436279|O2|Outcome|Osmotic Dilators|Placed 20-24 hours prior to procedure
237774|NCT01436279|O1|Outcome|Mifepristone + Misoprostol|Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure
238511|NCT01434290|O2|Outcome|12 Fractions|51.6 Gy IMRT in 12 fractions over two and a half weeks
237754|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237755|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237756|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237757|NCT01436305|E3|Reported Event|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
237758|NCT01436305|E2|Reported Event|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
237759|NCT01436305|E1|Reported Event|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.~Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.~Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.~Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.~Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
237760|NCT01436279|B3|Baseline|Total|Total of all reporting groups
237761|NCT01436279|B2|Baseline|Osmotic Dilators|Placed 20-24 hours prior to procedure
237762|NCT01436279|B1|Baseline|Mifepristone + Misoprostol|Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure
237763|NCT01436279|P2|Participant Flow|Osmotic Dilators|"Placed 20-24 hours prior to procedure~osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure"
237764|NCT01436279|P1|Participant Flow|Mifepristone + Misoprostol|"Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure~Mifepristone: 200 mg po 20-24 hours prior to the procedure"
237765|NCT01436279|O2|Outcome|Osmotic Dilators|"Placed 20-24 hours prior to procedure~osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure"
237766|NCT01436279|O1|Outcome|Mifepristone + Misoprostol|"Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure~Mifepristone: 200 mg po 20-24 hours prior to the procedure"
237767|NCT01436279|O2|Outcome|Osmotic Dilators|"Placed 20-24 hours prior to procedure~osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure"
237768|NCT01436279|O1|Outcome|Mifepristone + Misoprostol|"Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure~Mifepristone: 200 mg po 20-24 hours prior to the procedure"
237769|NCT01436279|O2|Outcome|Osmotic Dilators|"Placed 20-24 hours prior to procedure~osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure"
237777|NCT01436279|O2|Outcome|Osmotic Dilators|"Placed 20-24 hours prior to procedure~osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure"
237778|NCT01436279|O1|Outcome|Mifepristone + Misoprostol|"Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure~Mifepristone: 200 mg po 20-24 hours prior to the procedure"
237779|NCT01436279|O2|Outcome|Osmotic Dilators|Placed 20-24 hours prior to procedure
237780|NCT01436279|O1|Outcome|Mifepristone + Misoprostol|Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure
237781|NCT01436279|E2|Reported Event|Osmotic Dilators|"Placed 20-24 hours prior to procedure~osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure"
237782|NCT01436279|E1|Reported Event|Mifepristone + Misoprostol|"Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure~Mifepristone: 200 mg po 20-24 hours prior to the procedure"
237783|NCT01436266|B3|Baseline|Total|Total of all reporting groups
237784|NCT01436266|B2|Baseline|Placebo Comparator: Placebo (Folic Acid)|Two 1-mg tablets buccally 2 hours prior to procedure
237785|NCT01436266|B1|Baseline|Active Comparator: Misoprostol|400 mcg buccally 2 hours prior to procedure
237786|NCT01436266|P2|Participant Flow|Placebo Comparator: Placebo (Folic Acid)|Two 1-mg tablets buccally 2 hours prior to procedure
237787|NCT01436266|P1|Participant Flow|Active Comparator: Misoprostol|400 mcg buccally 2 hours prior to procedure
237788|NCT01436266|O2|Outcome|Placebo Comparator: Placebo (Folic Acid)|Two 1-mg tablets buccally 2 hours prior to procedure
237789|NCT01436266|O1|Outcome|Active Comparator: Misoprostol|400 mcg buccally 2 hours prior to procedure
237790|NCT01436266|E2|Reported Event|Placebo (Folic Acid)|"Two 1-mg tablets buccally 2 hours prior to procedure~Folic acid: 2mg buccally 2 hours prior to procedure"
237791|NCT01436266|E1|Reported Event|Misoprostol|"400 mcg buccally 2 hours prior to procedure~Misoprostol: 400 mcg buccally 2 hours prior to procedure"
237792|NCT01436253|B1|Baseline|All Participants|Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid levels on their current therapy.
237793|NCT01436253|P1|Participant Flow|All Participants|Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid levels on their current therapy.
237794|NCT01436253|O1|Outcome|All Participants|Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid values on their current therapy.
237795|NCT01436253|O1|Outcome|All Participants|Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid values on their current therapy.
237796|NCT01436253|E1|Reported Event|All Participants|Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid levels on their current therapy.
237797|NCT01436201|B1|Baseline|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 17.~Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
237798|NCT01436201|P1|Participant Flow|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 17.~Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
237799|NCT01436201|O2|Outcome|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 8 to Day 17.~Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
237800|NCT01436201|O1|Outcome|Digoxin Only|Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 7.
237801|NCT01436201|O2|Outcome|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 8 to Day 17.~Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
237802|NCT01436201|O1|Outcome|Digoxin Only|Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 7.
237803|NCT01436201|O2|Outcome|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 8 to Day 17.~Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
237804|NCT01436201|O1|Outcome|Digoxin Only|Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 7.
237805|NCT01436201|E2|Reported Event|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 8 to Day 17.~Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
237806|NCT01436201|E1|Reported Event|Digoxin|Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 7.
237807|NCT01436175|B1|Baseline|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
237808|NCT01436175|P1|Participant Flow|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
237809|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
238762|NCT01433081|E2|Reported Event|Placebo|.9 normal saline infusion
237810|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
237811|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
237812|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
237813|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
237814|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
237815|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
237816|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
237817|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 (Lisdexamfetamine dimesylate) + Antidepressant: SPD489 20mg, 30mg, 50mg, or 70mg + Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily for 52 weeks
237818|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
237819|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
237820|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
237821|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
237822|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
237823|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
237824|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
237825|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
237826|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
237827|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
238512|NCT01434290|O1|Outcome|5 Fractions|36.25 Gy IMRT in 5 fractions over two and a half weeks
237828|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
237829|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
237830|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
237831|NCT01436175|E1|Reported Event|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
237832|NCT01436162|B3|Baseline|Total|Total of all reporting groups
237833|NCT01436162|B2|Baseline|Antidepressant + Double-blind Placebo|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489) for 8 weeks.
237834|NCT01436162|B1|Baseline|Antidepressant + Double-blind SPD489|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride), plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among a 20, 30, 50, or 70 mg dose) for 8 weeks.
237835|NCT01436162|P3|Participant Flow|Antidepressant + Double-blind Placebo|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489).
237836|NCT01436162|P2|Participant Flow|Antidepressant + Double-blind SPD489|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride), plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among a 20, 30, 50, or 70 mg dose).
237837|NCT01436162|P1|Participant Flow|Antidepressant + Single-blind Placebo|Subjects received unblinded oral, once daily standard antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily placebo (matching SPD489).
237838|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks
237839|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
237840|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
237841|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
237842|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
237843|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
237844|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
237845|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
237846|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
237847|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
237848|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
237849|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
263467|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
237850|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
237851|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
237852|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
237853|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
237854|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
237855|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
237856|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
237857|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
237858|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
237859|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
237860|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
237861|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
237862|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
237863|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
237864|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
237865|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
237866|NCT01436162|E2|Reported Event|Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks
237867|NCT01436162|E1|Reported Event|SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate ): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + SPD489 (oral, 20, 30, 50 or 70 mg, once daily) for 8 weeks
237868|NCT01436149|B3|Baseline|Total|Total of all reporting groups
237869|NCT01436149|B2|Baseline|Antidepressant + Double-blind SPD489|Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among 20, 30, 50, or 70 mg dose) for 8 weeks.
237870|NCT01436149|B1|Baseline|Antidepressant + Double-blind Placebo|Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489) for 8 weeks.
237871|NCT01436149|P3|Participant Flow|Antidepressant + Double-blind SPD489|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among 20, 30, 50, or 70 mg dose).
237872|NCT01436149|P2|Participant Flow|Antidepressant + Double-blind Placebo|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489).
237987|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
237873|NCT01436149|P1|Participant Flow|Antidepressant + Single-blind Placebo|Subjects received unblinded oral, once daily standard antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended-release, or duloxetine hydrochloride) plus oral, once daily placebo (matching SPD489).
237874|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
237875|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
237876|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
237877|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
237878|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
237879|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
237880|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
237881|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
237882|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
237883|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
237884|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
237885|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
237886|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
237887|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
237888|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
237889|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
237890|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
237891|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
237892|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
237893|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
237894|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
237895|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
237896|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
237897|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
237898|NCT01436149|E2|Reported Event|Antidepressant + SPD489|Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride), plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among 20, 30, 50 or 70 mg dose).
237899|NCT01436149|E1|Reported Event|Antidepressant + Placebo|Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489).
237900|NCT01436110|B4|Baseline|Total|Total of all reporting groups
237901|NCT01436110|B3|Baseline|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237902|NCT01436110|B2|Baseline|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237903|NCT01436110|B1|Baseline|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237904|NCT01436110|P3|Participant Flow|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237905|NCT01436110|P2|Participant Flow|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237906|NCT01436110|P1|Participant Flow|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237907|NCT01436110|O3|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237908|NCT01436110|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237909|NCT01436110|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237910|NCT01436110|O3|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237911|NCT01436110|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237912|NCT01436110|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237913|NCT01436110|O3|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237914|NCT01436110|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237915|NCT01436110|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237916|NCT01436110|O3|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237917|NCT01436110|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237918|NCT01436110|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237919|NCT01436110|O3|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237920|NCT01436110|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237921|NCT01436110|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237922|NCT01436110|O3|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237923|NCT01436110|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237924|NCT01436110|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237925|NCT01436110|E3|Reported Event|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237926|NCT01436110|E2|Reported Event|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237927|NCT01436110|E1|Reported Event|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237928|NCT01436084|B1|Baseline|SB1518|400 mg orally a day for 28 day cycle.
237929|NCT01436084|P1|Participant Flow|SB1518|400 mg orally a day for 28 day cycle.
237930|NCT01436084|O1|Outcome|SB1518|400 mg orally a day for 28 day cycle.
237931|NCT01436084|E1|Reported Event|SB1518|400 mg orally a day for 28 day cycle.
237932|NCT01436071|B3|Baseline|Total|Total of all reporting groups
237933|NCT01436071|B2|Baseline|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237934|NCT01436071|B1|Baseline|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237935|NCT01436071|P2|Participant Flow|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237936|NCT01436071|P1|Participant Flow|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237937|NCT01436071|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237938|NCT01436071|O1|Outcome|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237939|NCT01436071|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237940|NCT01436071|O1|Outcome|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237941|NCT01436071|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237942|NCT01436071|O1|Outcome|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237943|NCT01436071|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237944|NCT01436071|O1|Outcome|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237945|NCT01436071|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237946|NCT01436071|O1|Outcome|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237947|NCT01436071|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
263468|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
237948|NCT01436071|O1|Outcome|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237949|NCT01436071|E2|Reported Event|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237950|NCT01436071|E1|Reported Event|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
237951|NCT01436045|B1|Baseline|All Study Partipants|Participants who received either intranasal glulisine (0.10 milliliter (mL) in each nostril, 20 IU total) or placebo (0.10 mL in each nostril) at the 2nd or 3rd study visit.
237952|NCT01436045|P2|Participant Flow|Placebo, Then Insulin Glulisine|"A randomized, double-blind, placebo-controlled, cross-over designed - all subject will receive intervention (insulin glulisine) and placebo (saline) during separate visits.~Placebo (5 minutes), Washout (1 week), Insulin Glulisine (5 minutes)~Insulin glulisine: Single treatment, 20 IU/Intranasal (.1ml/10 units Intranasally in each nostril)~Placebo: Single treatment,(saline) 20 IU/Intranasal (.1ml/10units intranasally in each nostril)"
237953|NCT01436045|P1|Participant Flow|Insulin Glulisine, Then Placebo|"A randomized, double-blind, placebo-controlled, cross-over designed - all subject will receive intervention (insulin glulisine) and placebo (saline) during separate visits.~Insulin glulisine (5 minutes), Washout (1 week), Placebo (5 minutes)~Insulin glulisine: Single treatment, 20 IU/Intranasal (.1ml/10 units Intranasally in each nostril)~Placebo: Single treatment,(saline) 20 IU/Intranasal (.1ml/10units intranasally in each nostril)"
237954|NCT01436045|O2|Outcome|Post-Placebo|Results of cognitive assessment after intranasal treatment with Placebo.
237955|NCT01436045|O1|Outcome|Post-Insulin Glulisine|Results of cognitive assessment after intranasal treatment with Insulin Glulisine.
237956|NCT01436045|O2|Outcome|Post-Placebo|Results of cognitive assessment after intranasal treatment with Placebo.
237957|NCT01436045|O1|Outcome|Post-Insulin Glulisine|Results of cognitive assessment after intranasal treatment with Insulin Glulisine.
237958|NCT01436045|O2|Outcome|Post Placebo|Results of cognitive assessment after intranasal treatment with Placebo.
237959|NCT01436045|O1|Outcome|Post-Insulin Glulisine|Results of cognitive assessment after intranasal treatment with Insulin Glulisine.
237960|NCT01436045|O2|Outcome|Post-Placebo|Results of cognitive assessment after intranasal treatment with Placebo.
237961|NCT01436045|O1|Outcome|Post-Insulin Glulisine|Results of cognitive assessment after intranasal treatment with Insulin Glulisine.
237962|NCT01436045|E1|Reported Event|All Study Partipants|Participants who received either intranasal glulisine (0.10 mL in each nostril, 20 IU total) or placebo (0.10 mL in each nostril) at the 2nd or 3rd study visit.
237963|NCT01436006|B1|Baseline|CT Scan|patient with cancer
237964|NCT01436006|P1|Participant Flow|CT Scan|"A total of 65 radiology departments, with 70 MDCT scanners, collected data of 5942 adult patients, randomly chosen, who underwent to CT examinations for common clinical for 5 common different protocols including also new examination that will be in the near future common practise as cardiac CT.~A prevalence of multiphasic study was documented in many chest abdomen and pelvis (CAP) studies and abdominal studies."
237965|NCT01436006|O1|Outcome|CT Adult Spine|Adult patients submitted to spine CT
237966|NCT01436006|O1|Outcome|Adult Patient Chest Abdomen and Pelvis|Adult patients submitted to chest abdomen and pelvis CT examinations.
237967|NCT01436006|O1|Outcome|Adult Cardiac CT|Adult patients submitted to cardiac CT
237968|NCT01436006|O2|Outcome|Abdomen CT Pediatric|Pediatric patients submitted to abdomen CT
237969|NCT01436006|O1|Outcome|Abdomen CT Adults|Adult patients submitted to abdomen CT
237970|NCT01436006|O2|Outcome|Chest CT- Pediatric|Pediatric patients submitted to chest CT
237971|NCT01436006|O1|Outcome|Chest CT- Adult|Adult patients submitted to chest CT
237972|NCT01436006|O2|Outcome|Pediatric|Pediatric patients submitted to head CT scan
237973|NCT01436006|O1|Outcome|Adult|Adult patients submitted to head CT scan
237974|NCT01436006|E1|Reported Event|Adverse Reaction to CT|Patients submitted to CT
237975|NCT01435928|B3|Baseline|Total|Total of all reporting groups
237976|NCT01435928|B2|Baseline|Placebo|During double blind phase subjects received matching placebo.
237977|NCT01435928|B1|Baseline|Lurasidone|During double blind phase subjects received Lurasidone flexibly dosed 40 or 80 mg once daily
237978|NCT01435928|P3|Participant Flow|Placebo|During double blind phase subjects received matching placebo.
237979|NCT01435928|P2|Participant Flow|Lurasidone|During double blind phase subjects received Lurasidone flexibly dosed 40 or 80 mg once daily
237980|NCT01435928|P1|Participant Flow|All Subjects|During the Open Label Phase subjects will receive Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating
237981|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
237982|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
237983|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
237984|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
237985|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
237986|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
238513|NCT01434290|O2|Outcome|12 Fractions|51.6 Gy IMRT in 12 fractions over two and a half weeks
237988|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
237989|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
237990|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
237991|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
237992|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
237993|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
237994|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
237995|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
237996|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
237997|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
237998|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
237999|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
238000|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
238001|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
238002|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
238003|NCT01435928|E3|Reported Event|Placebo|During double blind phase subjects received matching placebo.
238004|NCT01435928|E2|Reported Event|Lurasidone|During double blind phase subjects received Lurasidone flexibly dosed 40 or 80 mg once daily
238005|NCT01435928|E1|Reported Event|All Subjects|During the Open Label Phase subjects will receive Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating
238006|NCT01435798|B1|Baseline|Dextromethorphan Dose Response Clinical Trial|Each subject received four doses of dextromethorphan; 0% (placebo), 25%, 50%, and 100% of the maximum tolerated dose in a balanced randomized order. Each dose was administered for a period of 28 days; on day 21 of each phase, subjects traveled to the study site to undergo study procedures in a nested clinical trial (not described here).
238007|NCT01435798|P1|Participant Flow|Dextromethorphan Dose Response (DDR) Clinical Trial|Each subject received four doses of dextromethorphan; 0% (placebo), 25%, 50%, and 100% of the maximum tolerated dose in a balanced randomized order. Each dose was administered for a period of 28 days; on day 21 of each phase, subjects traveled to the study site to undergo study procedures in a nested clinical trial (not described here).
238008|NCT01435798|O4|Outcome|100% MTD Dex|100% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
238009|NCT01435798|O3|Outcome|50% MTD Dex|50% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
238010|NCT01435798|O2|Outcome|25% MTD Dex|25% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
238011|NCT01435798|O1|Outcome|0% MTD Dex|0% (placebo) of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
238012|NCT01435798|O4|Outcome|100% MTD Dex|100% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
238013|NCT01435798|O3|Outcome|50% MTD Dex|50% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
238014|NCT01435798|O2|Outcome|25% MTD Dex|25% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
238015|NCT01435798|O1|Outcome|0% MTD Dex|0% (placebo) of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
238016|NCT01435798|E4|Reported Event|100% MTD Dex|100% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
238017|NCT01435798|E3|Reported Event|50% MTD Dex|50% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
238514|NCT01434290|O1|Outcome|5 Fractions|36.25 Gy IMRT in 5 fractions over two and a half weeks
238018|NCT01435798|E2|Reported Event|25% MTD Dex|25% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
238019|NCT01435798|E1|Reported Event|0% MTD Dex|0% (placebo) of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
238020|NCT01435772|B4|Baseline|Total|Total of all reporting groups
238021|NCT01435772|B3|Baseline|BMN 701 20 mg/kg|IV infusion at dose levels of 20 mg/kg
238022|NCT01435772|B2|Baseline|BMN 701 10 mg/kg|IV infusion at dose levels of 10 mg/kg
238023|NCT01435772|B1|Baseline|BMN 701 5 mg/kg|IV infusion at dose levels of 5 mg/kg
238024|NCT01435772|P3|Participant Flow|BMN 701 20 mg/kg|IV infusion at dose levels of 20 mg/kg
238025|NCT01435772|P2|Participant Flow|BMN 701 10 mg/kg|IV infusion at dose levels of 10 mg/kg
238026|NCT01435772|P1|Participant Flow|BMN 701 5 mg/kg|IV infusion at dose levels of 5 mg/kg
238027|NCT01435772|O3|Outcome|BMN 701 20 mg/kg|IV infusion at dose levels of 20 mg/kg
238028|NCT01435772|O2|Outcome|BMN 701 10 mg/kg|IV infusion at dose levels of 10 mg/kg
238029|NCT01435772|O1|Outcome|BMN 701 5 mg/kg|IV infusion at dose levels of 5 mg/kg
238030|NCT01435772|O3|Outcome|BMN 701 20 mg/kg|IV infusion at dose levels of 20 mg/kg
238031|NCT01435772|O2|Outcome|BMN 701 10 mg/kg|IV infusion at dose levels of 10 mg/kg
238032|NCT01435772|O1|Outcome|BMN 701 5 mg/kg|IV infusion at dose levels of 5 mg/kg
238033|NCT01435772|O3|Outcome|BMN 701 20 mg/kg|IV infusion at dose levels of 20 mg/kg
238034|NCT01435772|O2|Outcome|BMN 701 10 mg/kg|IV infusion at dose levels of 10 mg/kg
238035|NCT01435772|O1|Outcome|BMN 701 5 mg/kg|IV infusion at dose levels of 5 mg/kg
238036|NCT01435772|O3|Outcome|BMN 701 20 mg/kg|IV infusion at dose levels of 20 mg/kg
238037|NCT01435772|O2|Outcome|BMN 701 10 mg/kg|IV infusion at dose levels of 10 mg/kg
238038|NCT01435772|O1|Outcome|BMN 701 5 mg/kg|IV infusion at dose levels of 5 mg/kg
238039|NCT01435772|O3|Outcome|BMN 701 20 mg/kg|IV infusion at dose levels of 20 mg/kg
238040|NCT01435772|O2|Outcome|BMN 701 10 mg/kg|IV infusion at dose levels of 10 mg/kg
238041|NCT01435772|O1|Outcome|BMN 701 5 mg/kg|IV infusion at dose levels of 5 mg/kg
238042|NCT01435772|O3|Outcome|BMN 701 20 mg/kg|IV infusion at dose levels of 20 mg/kg
238043|NCT01435772|O2|Outcome|BMN 701 10 mg/kg|IV infusion at dose levels of 10 mg/kg
238044|NCT01435772|O1|Outcome|BMN 701 5 mg/kg|IV infusion at dose levels of 5 mg/kg
238045|NCT01435772|O3|Outcome|BMN 701 20 mg/kg|IV infusion at dose levels of 20 mg/kg
238046|NCT01435772|O2|Outcome|BMN 701 10 mg/kg|IV infusion at dose levels of 10 mg/kg
238047|NCT01435772|O1|Outcome|BMN 701 5 mg/kg|IV infusion at dose levels of 5 mg/kg
238048|NCT01435772|O3|Outcome|BMN 701 20 mg/kg|IV infusion at dose levels of 20 mg/kg
238049|NCT01435772|O2|Outcome|BMN 701 10 mg/kg|IV infusion at dose levels of 10 mg/kg
238050|NCT01435772|O1|Outcome|BMN 701 5 mg/kg|IV infusion at dose levels of 5 mg/kg
238051|NCT01435772|O3|Outcome|BMN 701 20 mg/kg|IV infusion at dose levels of 20 mg/kg
238052|NCT01435772|O2|Outcome|BMN 701 10 mg/kg|IV infusion at dose levels of 10 mg/kg
238053|NCT01435772|O1|Outcome|BMN 701 5 mg/kg|IV infusion at dose levels of 5 mg/kg
238054|NCT01435772|O3|Outcome|BMN 701 20 mg/kg|IV infusion at dose levels of 20 mg/kg
238055|NCT01435772|O2|Outcome|BMN 701 10 mg/kg|IV infusion at dose levels of 10 mg/kg
238056|NCT01435772|O1|Outcome|BMN 701 5 mg/kg|IV infusion at dose levels of 5 mg/kg
238057|NCT01435772|O3|Outcome|BMN 701 20 mg/kg|IV infusion at dose levels of 20 mg/kg
238058|NCT01435772|O2|Outcome|BMN 701 10 mg/kg|IV infusion at dose levels of 10 mg/kg
238059|NCT01435772|O1|Outcome|BMN 701 5 mg/kg|IV infusion at dose levels of 5 mg/kg
238060|NCT01435772|O3|Outcome|BMN 701 20 mg/kg|IV infusion at dose levels of 20 mg/kg
238061|NCT01435772|O2|Outcome|BMN 701 10 mg/kg|IV infusion at dose levels of 10 mg/kg
238062|NCT01435772|O1|Outcome|BMN 701 5 mg/kg|IV infusion at dose levels of 5 mg/kg
238063|NCT01435772|O3|Outcome|BMN 701 20 mg/kg|IV infusion at dose levels of 20 mg/kg
238064|NCT01435772|O2|Outcome|BMN 701 10 mg/kg|IV infusion at dose levels of 10 mg/kg
238065|NCT01435772|O1|Outcome|BMN 701 5 mg/kg|IV infusion at dose levels of 5 mg/kg
238066|NCT01435772|E4|Reported Event|Total|Total
238067|NCT01435772|E3|Reported Event|BMN 701 20 mg/kg|BMN 701 20 mg/kg
238068|NCT01435772|E2|Reported Event|BMN 701 10 mg/kg|BMN 701 10 mg/kg
238069|NCT01435772|E1|Reported Event|BMN 701 5 mg/kg|BMN 701 5 mg/kg
238070|NCT01435759|B6|Baseline|Total|Total of all reporting groups
238071|NCT01435759|B5|Baseline|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
238072|NCT01435759|B4|Baseline|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
238073|NCT01435759|B3|Baseline|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
238074|NCT01435759|B2|Baseline|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
238075|NCT01435759|B1|Baseline|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
238076|NCT01435759|P6|Participant Flow|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
238077|NCT01435759|P5|Participant Flow|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
238078|NCT01435759|P4|Participant Flow|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
238079|NCT01435759|P3|Participant Flow|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
238080|NCT01435759|P2|Participant Flow|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
238081|NCT01435759|P1|Participant Flow|Antidepressant + Single-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily single-blind placebo (matching SPD489).
238082|NCT01435759|O5|Outcome|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
238083|NCT01435759|O4|Outcome|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
238084|NCT01435759|O3|Outcome|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
238085|NCT01435759|O2|Outcome|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
238086|NCT01435759|O1|Outcome|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
238087|NCT01435759|O5|Outcome|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
238088|NCT01435759|O4|Outcome|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
238089|NCT01435759|O3|Outcome|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
238090|NCT01435759|O2|Outcome|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
238091|NCT01435759|O1|Outcome|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
238092|NCT01435759|O5|Outcome|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
238093|NCT01435759|O4|Outcome|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
238094|NCT01435759|O3|Outcome|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
238095|NCT01435759|O2|Outcome|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
238096|NCT01435759|O1|Outcome|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
238097|NCT01435759|O5|Outcome|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
238098|NCT01435759|O4|Outcome|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
238515|NCT01434290|O2|Outcome|12 Fractions|51.6 Gy IMRT in 12 fractions over two and a half weeks
238099|NCT01435759|O3|Outcome|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
238100|NCT01435759|O2|Outcome|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
238101|NCT01435759|O1|Outcome|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
238102|NCT01435759|E5|Reported Event|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
238103|NCT01435759|E4|Reported Event|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
238104|NCT01435759|E3|Reported Event|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
238105|NCT01435759|E2|Reported Event|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
238106|NCT01435759|E1|Reported Event|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
238107|NCT01435655|B1|Baseline|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
238108|NCT01435655|P1|Participant Flow|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
238109|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
238110|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
238111|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
238112|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
238113|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
238114|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
238115|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
238116|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
238117|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
238118|NCT01435655|E1|Reported Event|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
238119|NCT01435616|B3|Baseline|Total|Total of all reporting groups
238120|NCT01435616|B2|Baseline|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 or 78 weeks
238121|NCT01435616|B1|Baseline|LY2605541|LY2605541 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 or 78 weeks
238122|NCT01435616|P2|Participant Flow|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 or 78 weeks
238123|NCT01435616|P1|Participant Flow|LY2605541|LY2605541 titrated based on blood glucose readings, administered subcutaneously (SC), once daily in combination with at least 2 pre-study oral antihyperglycemic medications (OAMs) prescribed by the personal physician, for 52 or 78 weeks
238124|NCT01435616|O2|Outcome|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238125|NCT01435616|O1|Outcome|LY2605541|LY2605541 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238126|NCT01435616|O2|Outcome|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238127|NCT01435616|O1|Outcome|LY2605541|LY2605541 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238128|NCT01435616|O2|Outcome|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238129|NCT01435616|O1|Outcome|LY2605541|LY2605541 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238130|NCT01435616|O2|Outcome|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238131|NCT01435616|O1|Outcome|LY2605541|LY2605541 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238132|NCT01435616|O2|Outcome|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 or 78 weeks
238133|NCT01435616|O1|Outcome|LY2605541|LY2605541 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 or 78 weeks
238134|NCT01435616|O2|Outcome|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238135|NCT01435616|O1|Outcome|LY2605541|LY2605541 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238136|NCT01435616|O2|Outcome|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238137|NCT01435616|O1|Outcome|LY2605541|LY2605541 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238138|NCT01435616|O2|Outcome|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238139|NCT01435616|O1|Outcome|LY2605541|LY2605541 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238140|NCT01435616|O2|Outcome|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238141|NCT01435616|O1|Outcome|LY2605541|LY2605541 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238142|NCT01435616|O2|Outcome|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238143|NCT01435616|O1|Outcome|LY2605541|LY2605541 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238144|NCT01435616|O2|Outcome|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238145|NCT01435616|O1|Outcome|LY2605541|LY2605541 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238146|NCT01435616|O2|Outcome|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238147|NCT01435616|O1|Outcome|LY2605541|LY2605541 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238148|NCT01435616|O2|Outcome|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238149|NCT01435616|O1|Outcome|LY2605541|LY2605541 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238150|NCT01435616|O2|Outcome|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238151|NCT01435616|O1|Outcome|LY2605541|LY2605541 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238152|NCT01435616|O2|Outcome|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238153|NCT01435616|O1|Outcome|LY2605541|LY2605541 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238154|NCT01435616|O2|Outcome|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238155|NCT01435616|O1|Outcome|LY2605541|LY2605541 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238156|NCT01435616|O2|Outcome|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238157|NCT01435616|O1|Outcome|LY2605541|LY2605541 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238158|NCT01435616|O2|Outcome|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238159|NCT01435616|O1|Outcome|LY2605541|LY2605541 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238160|NCT01435616|O2|Outcome|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238161|NCT01435616|O1|Outcome|LY2605541|LY2605541 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238283|NCT01435122|O1|Outcome|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
238162|NCT01435616|O2|Outcome|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238163|NCT01435616|O1|Outcome|LY2605541|LY2605541 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238164|NCT01435616|E2|Reported Event|Glargine|Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238165|NCT01435616|E1|Reported Event|LY2605541|LY2605541 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
238166|NCT01435603|B3|Baseline|Total|Total of all reporting groups
238167|NCT01435603|B2|Baseline|Advice Plus Lifestyle Intervention|"Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting.~Standard Lifestyle Advice: See Standard Lifestyle Advice arm.~Advice Plus Lifestyle Intervention: Standard clinical education offered by the participant's usual primary care team. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team."
238168|NCT01435603|B1|Baseline|Standard Lifestyle Advice|"Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant).~Standard Lifestyle Advice: Standard clinical education is offered routinely by the participant's usual primary care team. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months."
238169|NCT01435603|P2|Participant Flow|Advice Plus Lifestyle Intervention|"Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting.~Standard Lifestyle Advice: See Standard Lifestyle Advice arm.~Advice Plus Lifestyle Intervention: Standard clinical education offered by the participant's usual primary care team. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team."
238170|NCT01435603|P1|Participant Flow|Standard Lifestyle Advice|"Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant).~Standard Lifestyle Advice: Standard clinical education is offered routinely by the participant's usual primary care team. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months."
238171|NCT01435603|O2|Outcome|Advice Plus Lifestyle Intervention|"Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting.~Standard Lifestyle Advice: See Standard Lifestyle Advice arm.~Advice Plus Lifestyle Intervention: Standard clinical education offered by the participant's usual primary care team. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team."
238172|NCT01435603|O1|Outcome|Standard Lifestyle Advice|"Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant).~Standard Lifestyle Advice: Standard clinical education is offered routinely by the participant's usual primary care team. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months."
238173|NCT01435603|E2|Reported Event|Advice Plus Lifestyle Intervention|"Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting.~Standard Lifestyle Advice: See Standard Lifestyle Advice arm.~Advice Plus Lifestyle Intervention: Standard clinical education offered by the participant's usual primary care team. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team."
238174|NCT01435603|E1|Reported Event|Standard Lifestyle Advice|"Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant).~Standard Lifestyle Advice: Standard clinical education is offered routinely by the participant's usual primary care team. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months."
238175|NCT01435577|B3|Baseline|Total|Total of all reporting groups
238176|NCT01435577|B2|Baseline|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
238177|NCT01435577|B1|Baseline|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
238208|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
238407|NCT01434693|B1|Baseline|Placebo|Placebo: single dose
238178|NCT01435577|P2|Participant Flow|Matching Placebo Intravenous|"Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.~65 Randomized participants, 65 Participants in the Safety Set (SAF), 65 Participants in the Full Analysis Set(FAS). The FAS comprised all randomized subjects who were administered at least 1 dose and had a baseline pain assessment."
238179|NCT01435577|P1|Participant Flow|Tapentadol Intravenous|"Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.~64 Participants Randomized, 64 Participants in the Safety Set (SAF), 64 Participants in the Full Analysis Set (FAS). The FAS comprised all randomized subjects who were administered at least 1 dose and had a baseline pain assessment."
238180|NCT01435577|O1|Outcome|Matching Placebo Intravenous|Matching Placebo will be given by intravenous infusion. Matching Placebo will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
238181|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
238182|NCT01435577|O1|Outcome|Tapentadol Intravenous|Pharmacokinetic samples were taken from all participants, however only samples from the tapentadol treatment group were analyzed.
238183|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
238184|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
238185|NCT01435577|O1|Outcome|Tapentadol Intravenous|Pharmacokinetic samples were taken from all participants, however only samples from the tapentadol treatment group were analyzed.
238186|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone. Values collected after 12 hours were censored, i.e. participants scored as having no meaningful pain relief.
238187|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
238188|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
238189|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
238190|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
238191|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
238192|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
238193|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
238194|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
238195|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
238196|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
238197|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
238198|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
238199|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
238200|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
238201|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
238202|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
238203|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
238204|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
238205|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
238206|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
238207|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
238209|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
238210|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
238211|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
238212|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
238213|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
238214|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
238215|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
238216|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
238217|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
238218|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
238219|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
238220|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
238221|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
238222|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
238223|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
238224|NCT01435577|E2|Reported Event|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
238225|NCT01435577|E1|Reported Event|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
238226|NCT01435460|B3|Baseline|Total|Total of all reporting groups
238227|NCT01435460|B2|Baseline|Patanol|Ophthalmic solution containing olopatadine, 0.1%
238228|NCT01435460|B1|Baseline|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
238229|NCT01435460|P2|Participant Flow|Patanol|Ophthalmic solution containing olopatadine, 0.1%
238230|NCT01435460|P1|Participant Flow|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
238231|NCT01435460|O2|Outcome|Patanol|Ophthalmic solution containing olopatadine, 0.1%
238232|NCT01435460|O1|Outcome|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
238233|NCT01435460|O2|Outcome|Patanol|Ophthalmic solution containing olopatadine, 0.1%
238234|NCT01435460|O1|Outcome|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
238235|NCT01435460|O2|Outcome|Patanol|Ophthalmic solution containing olopatadine, 0.1%
238236|NCT01435460|O1|Outcome|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
238237|NCT01435460|O2|Outcome|Patanol|Ophthalmic solution containing olopatadine, 0.1%
238238|NCT01435460|O1|Outcome|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
238239|NCT01435460|E2|Reported Event|Patanol|Ophthalmic solution containing olopatadine, 0.1%
238240|NCT01435460|E1|Reported Event|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
238241|NCT01435304|B3|Baseline|Total|Total of all reporting groups
238242|NCT01435304|B2|Baseline|Cell Saver|Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)
238243|NCT01435304|B1|Baseline|Hemobag®|"Hemobag® method of returning residual CPB blood (study group)~method of returning residual CPB blood ( Hemobag®): The Hemobag® is a collection reservoir used to facilitate ultrafiltration of the CPB circuit after the patient has been disconnected from CPB)."
238244|NCT01435304|P2|Participant Flow|Cell Saver|Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)
238245|NCT01435304|P1|Participant Flow|Hemobag®|"Hemobag® method of returning residual CPB blood (study group)~method of returning residual CPB blood ( Hemobag®): The Hemobag® is a collection reservoir used to facilitate ultrafiltration of the CPB circuit after the patient has been disconnected from CPB)."
238246|NCT01435304|O2|Outcome|Cell Saver|Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)
238247|NCT01435304|O1|Outcome|Hemobag®|"Hemobag® method of returning residual CPB blood (study group)~method of returning residual CPB blood ( Hemobag®): The Hemobag® is a collection reservoir used to facilitate ultrafiltration of the CPB circuit after the patient has been disconnected from CPB)."
238248|NCT01435304|O2|Outcome|Cell Saver|Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)
238249|NCT01435304|O1|Outcome|Hemobag®|"Hemobag® method of returning residual CPB blood (study group)~method of returning residual CPB blood ( Hemobag®): The Hemobag® is a collection reservoir used to facilitate ultrafiltration of the CPB circuit after the patient has been disconnected from CPB)."
238250|NCT01435304|O2|Outcome|Cell Saver|Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)
238251|NCT01435304|O1|Outcome|Hemobag®|"Hemobag® method of returning residual CPB blood (study group)~method of returning residual CPB blood ( Hemobag®): The Hemobag® is a collection reservoir used to facilitate ultrafiltration of the CPB circuit after the patient has been disconnected from CPB)."
238252|NCT01435304|O2|Outcome|Cell Saver|Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)
238253|NCT01435304|O1|Outcome|Hemobag®|"Hemobag® method of returning residual CPB blood (study group)~method of returning residual CPB blood ( Hemobag®): The Hemobag® is a collection reservoir used to facilitate ultrafiltration of the CPB circuit after the patient has been disconnected from CPB)."
238254|NCT01435304|O2|Outcome|Cell Saver|Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)
238255|NCT01435304|O1|Outcome|Hemobag®|"Hemobag® method of returning residual CPB blood (study group)~method of returning residual CPB blood ( Hemobag®): The Hemobag® is a collection reservoir used to facilitate ultrafiltration of the CPB circuit after the patient has been disconnected from CPB)."
238256|NCT01435304|O2|Outcome|Cell Saver|Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)
238257|NCT01435304|O1|Outcome|Hemobag®|"Hemobag® method of returning residual CPB blood (study group)~method of returning residual CPB blood ( Hemobag®): The Hemobag® is a collection reservoir used to facilitate ultrafiltration of the CPB circuit after the patient has been disconnected from CPB)."
238258|NCT01435304|E2|Reported Event|Cell Saver|Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)
238259|NCT01435304|E1|Reported Event|Hemobag®|"Hemobag® method of returning residual CPB blood (study group)~method of returning residual CPB blood ( Hemobag®): The Hemobag® is a collection reservoir used to facilitate ultrafiltration of the CPB circuit after the patient has been disconnected from CPB)."
238260|NCT01435265|B3|Baseline|Total|Total of all reporting groups
238261|NCT01435265|B2|Baseline|Additional Nurse Education-|Subjects will receive additional nurse education beyond the normal education materials provided by their physician
238262|NCT01435265|B1|Baseline|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
238263|NCT01435265|P2|Participant Flow|Additional Nurse Education-|Subjects will receive additional nurse education beyond the normal education materials provided by their physician
238264|NCT01435265|P1|Participant Flow|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
238265|NCT01435265|O2|Outcome|Additional Nurse Education-|Subjects will receive additional nurse education beyond the normal education materials provided by their physician
238266|NCT01435265|O1|Outcome|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
238267|NCT01435265|O2|Outcome|Additional Nurse Education-|Subjects will receive additional nurse education beyond the normal education materials provided by their physician
238268|NCT01435265|O1|Outcome|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
238269|NCT01435265|O2|Outcome|Additional Nurse Education-|Subjects will receive additional nurse education beyond the normal education materials provided by their physician
238270|NCT01435265|O1|Outcome|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
238271|NCT01435265|E2|Reported Event|Additional Nurse Education|Experimental: Additional Nurse Education- Subjects will receive additional nurse education beyond the normal education materials provided by their physician
238272|NCT01435265|E1|Reported Event|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
238273|NCT01435174|B1|Baseline|Ranolazine|"End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.~Ranolazine: A single dose of two oral ranolazine extended release 500 mg tablets~Pharmacokinetic Blood and Dialysate Sampling: Blood samples collected to assess ranolazine plasma and dialysate concentrations.~QT Interval: Calculation of a QT interval will be performed throughout subject participation."
238274|NCT01435174|P1|Participant Flow|Ranolazine|"End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.~Ranolazine: A single dose of two oral ranolazine extended release 500 mg tablets~Pharmacokinetic Blood and Dialysate Sampling: Blood samples collected to assess ranolazine plasma and dialysate concentrations.~QT Interval: Calculation of a QT interval will be performed throughout subject participation."
238275|NCT01435174|O1|Outcome|Ranolazine|"End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.~Ranolazine: A single dose of two oral ranolazine extended release 500 mg tablets~Pharmacokinetic Blood and Dialysate Sampling: Blood samples collected to assess ranolazine plasma and dialysate concentrations.~QT Interval: Calculation of a QT interval will be performed throughout subject participation."
238276|NCT01435174|E1|Reported Event|Ranolazine|"End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.~Ranolazine: A single dose of two oral ranolazine extended release 500 mg tablets~Pharmacokinetic Blood and Dialysate Sampling: Blood samples collected to assess ranolazine plasma and dialysate concentrations.~QT Interval: Calculation of a QT interval will be performed throughout subject participation."
238277|NCT01435122|B1|Baseline|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
238278|NCT01435122|P1|Participant Flow|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
238279|NCT01435122|O1|Outcome|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
238280|NCT01435122|O1|Outcome|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
238281|NCT01435122|O1|Outcome|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
238284|NCT01435122|O1|Outcome|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
238285|NCT01435122|E1|Reported Event|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
238286|NCT01435031|B1|Baseline|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238287|NCT01435031|P1|Participant Flow|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238288|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238289|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238290|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238291|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238292|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238293|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238294|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238295|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238296|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238408|NCT01434693|P4|Participant Flow|TSO 7500|Trichuris suis ova : single dose
238409|NCT01434693|P3|Participant Flow|TSO 2500|Trichuris suis ova : single dose
238410|NCT01434693|P2|Participant Flow|TSO 500|Trichuris suis ova : single dose
238411|NCT01434693|P1|Participant Flow|Placebo|Placebo: single dose
238412|NCT01434693|O4|Outcome|TSO 7500|Trichuris suis ova : single dose
238297|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238298|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238299|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238300|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238301|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238302|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238303|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238304|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238305|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238306|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238307|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238308|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238413|NCT01434693|O3|Outcome|TSO 2500|Trichuris suis ova : single dose
238414|NCT01434693|O2|Outcome|TSO 500|Trichuris suis ova : single dose
238309|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238310|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238311|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238312|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238313|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238314|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238315|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238316|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238317|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238318|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238319|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238320|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238415|NCT01434693|O1|Outcome|Placebo|Placebo: single dose
238416|NCT01434693|E4|Reported Event|TSO 7500|Trichuris suis ova : single dose
238321|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238322|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238323|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238324|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238325|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238326|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238327|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238328|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238329|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238330|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238331|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238332|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238417|NCT01434693|E3|Reported Event|TSO 2500|Trichuris suis ova : single dose
238418|NCT01434693|E2|Reported Event|TSO 500|Trichuris suis ova : single dose
238333|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238334|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238335|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238336|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238337|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238338|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238339|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238340|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238341|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238342|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238343|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238344|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238419|NCT01434693|E1|Reported Event|Placebo|Placebo: single dose
238420|NCT01434680|B5|Baseline|Total|Total of all reporting groups
238345|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238346|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238347|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238348|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238349|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238350|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238351|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238352|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238353|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238354|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238355|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238356|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238421|NCT01434680|B4|Baseline|MenC-CRM ROS_EMV|Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
238357|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238358|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238359|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238360|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238361|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238362|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238363|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238364|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238365|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238366|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238367|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238368|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238422|NCT01434680|B3|Baseline|MenC-CRM EMV|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
238369|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238370|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238371|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238372|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238373|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238374|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238375|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238376|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238377|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238378|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238379|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238380|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238423|NCT01434680|B2|Baseline|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
238381|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238382|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238383|NCT01435031|E1|Reported Event|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
238384|NCT01434823|B3|Baseline|Total|Total of all reporting groups
238385|NCT01434823|B2|Baseline|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
238386|NCT01434823|B1|Baseline|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
238387|NCT01434823|P2|Participant Flow|Control - Standard of Care|"The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).~Randomization was blocked such that 1 week of a 2-week attending block of service was randomized to nocturnal coverage. We also calculated the proportion of covered nights for each patient's ICU stay."
238388|NCT01434823|P1|Participant Flow|Intervention - Nocturnal Coverage|"Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.~Randomization was blocked such that 1 week of a 2-week attending block of service was randomized to nocturnal coverage. We also calculated the proportion of covered nights for each patient's ICU stay in secondary analyses."
238389|NCT01434823|O2|Outcome|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
238390|NCT01434823|O1|Outcome|Intervention - Nocturnal Coverage|"Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.~Nocturnal coverage: The investigators will randomize, by week, nocturnal coverage. During the intervention weeks, intensivists will be in the MICU from 7pm until 7am.~For the Intensivist Sleep and Work sub-study:~Measurements of Daytime Intensivist work hours, sleep, and attention will be measured with actigraphy, PVT, Sleep and Work Diaries, and Surveys. Results will be compared between periods with standard staffing to periods with overnight intensivist coverage."
238391|NCT01434823|O2|Outcome|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
238392|NCT01434823|O1|Outcome|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
238393|NCT01434823|O2|Outcome|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
238394|NCT01434823|O1|Outcome|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
238395|NCT01434823|O2|Outcome|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
238396|NCT01434823|O1|Outcome|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
238397|NCT01434823|O2|Outcome|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
238398|NCT01434823|O1|Outcome|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
238399|NCT01434823|O2|Outcome|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
238400|NCT01434823|O1|Outcome|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
238401|NCT01434823|E2|Reported Event|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
238402|NCT01434823|E1|Reported Event|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
238403|NCT01434693|B5|Baseline|Total|Total of all reporting groups
238404|NCT01434693|B4|Baseline|TSO 7500|Trichuris suis ova : single dose
238405|NCT01434693|B3|Baseline|TSO 2500|Trichuris suis ova : single dose
238406|NCT01434693|B2|Baseline|TSO 500|Trichuris suis ova : single dose
238425|NCT01434680|P4|Participant Flow|MenC-CRM ROS_EMV|Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
238426|NCT01434680|P3|Participant Flow|MenC-CRM EMV|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
238427|NCT01434680|P2|Participant Flow|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
238428|NCT01434680|P1|Participant Flow|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
238429|NCT01434680|O4|Outcome|MenC-CRM ROS_EMV|Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
238430|NCT01434680|O3|Outcome|MenC-CRM EMV|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
238431|NCT01434680|O2|Outcome|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
238432|NCT01434680|O1|Outcome|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
238433|NCT01434680|O2|Outcome|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
238434|NCT01434680|O1|Outcome|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
238435|NCT01434680|O3|Outcome|MenC-CRM EMV|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
238436|NCT01434680|O2|Outcome|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
238437|NCT01434680|O1|Outcome|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
238438|NCT01434680|E4|Reported Event|MenC-CRM ROS_EMV|Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
238439|NCT01434680|E3|Reported Event|MenC-CRM EMV|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
238440|NCT01434680|E2|Reported Event|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
238441|NCT01434680|E1|Reported Event|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
238442|NCT01434654|B3|Baseline|Total|Total of all reporting groups
238443|NCT01434654|B2|Baseline|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
238444|NCT01434654|B1|Baseline|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
238445|NCT01434654|P2|Participant Flow|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
238446|NCT01434654|P1|Participant Flow|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
238447|NCT01434654|O2|Outcome|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
238448|NCT01434654|O1|Outcome|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
238449|NCT01434654|O2|Outcome|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
238450|NCT01434654|O1|Outcome|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
238451|NCT01434654|O2|Outcome|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are allocated to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
238516|NCT01434290|O1|Outcome|5 Fractions|36.25 Gy IMRT in 5 fractions over two and a half weeks
238517|NCT01434290|E2|Reported Event|12 Fractions|51.6 Gy IMRT in 12 fractions over two and a half weeks
238452|NCT01434654|O1|Outcome|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are allocated to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
238453|NCT01434654|O2|Outcome|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are allocated to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
238454|NCT01434654|O1|Outcome|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are allocated to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
238455|NCT01434654|E2|Reported Event|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
238456|NCT01434654|E1|Reported Event|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
238457|NCT01434641|B1|Baseline|Myocardial Perfusion SPECT|The 102 study patients underwent a very low-activity stress/high-activity rest, single-day myocardial perfusion SPECT ith a conventional sodium iodide camera and wide beam reconstruction processing.
238458|NCT01434641|P1|Participant Flow|Stress/Rest Myocardial Perfusion SPECT Patients|All patients referred for clinically indicated myocardial perfusion SPECT are eligible candidates for this protocol. Low-dose stress/high-dose rest myocardial perfusion SPECT is performed according to the protocol and image quality and rest/stress myocardial count density ratios are assessed.
238459|NCT01434641|O1|Outcome|Myocardial Perfusion SPECT|Participants underwent novel low-dose rest/high-dose Tc-99m sestamibi SPECT protocol with wide beam reconstruction SPECT processing
238460|NCT01434641|O1|Outcome|Myocardial Perfusion SPECT|Participants underwent novel low-dose rest/high-dose Tc-99m sestamibi SPECT protocol with wide beam reconstruction SPECT processing
238461|NCT01434641|E1|Reported Event|Myocardial Perfusion SPECT|
238462|NCT01434511|B1|Baseline|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
238463|NCT01434511|P1|Participant Flow|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
238464|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
238465|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
238466|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
238467|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
238468|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
238469|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
238470|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
238471|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
238472|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
238473|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
238474|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
238475|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
238476|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
238477|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
238478|NCT01434511|E1|Reported Event|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
238479|NCT01434342|B3|Baseline|Total|Total of all reporting groups
238480|NCT01434342|B2|Baseline|Arm II|Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute’s “Clearing the Air” smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
238481|NCT01434342|B1|Baseline|Arm I - Quitline|"Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff. The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Participants also learn behavioral tips and coping skills.~Nicotine Replacement Patch: Study participants will receive a baseline assessment after they consent to participate and before randomization. The intervention period will last 12 weeks (approximately 1 week for the in-office intervention and 12 weeks for all components of the Quitline intervention- telephone counseling and habitrol patches). Follow-up assessments will be administered at 3, 6, 12, & 24 we"
238518|NCT01434290|E1|Reported Event|5 Fractions|36.25 Gy IMRT in 5 fractions over two and a half weeks
238519|NCT01434186|B3|Baseline|Total|Total of all reporting groups
238482|NCT01434342|P2|Participant Flow|Arm II - Usual Care|Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute’s “Clearing the Air” smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
238483|NCT01434342|P1|Participant Flow|Arm I - Quitline|"Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff. The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Participants also learn behavioral tips and coping skills.~Nicotine Replacement Patch: Study participants will receive a baseline assessment after they consent to participate and before randomization. The intervention period will last 12 weeks (approximately 1 week for the in-office intervention and 12 weeks for all components of the Quitline intervention- telephone counseling and habitrol patches). Follow-up assessments will be administered at 3, 6, 12, & 24 we"
238484|NCT01434342|O2|Outcome|Arm II - Usual Care|Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute’s “Clearing the Air” smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
238485|NCT01434342|O1|Outcome|Arm I - Quitline|"Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff.~The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients.~Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period.~Participants also learn behavioral tips and coping skills."
238486|NCT01434342|O2|Outcome|Arm II - Usual Care|Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute’s “Clearing the Air” smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
238487|NCT01434342|O1|Outcome|Arm I - Quitline|"Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff.~The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients.~Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period.~Participants also learn behavioral tips and coping skills."
238488|NCT01434342|E2|Reported Event|Arm II - Usual Care|Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute’s “Clearing the Air” smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
238489|NCT01434342|E1|Reported Event|Arm I - Quitline|"Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff. The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Participants also learn behavioral tips and coping skills.~Nicotine Replacement Patch: Study participants will receive a baseline assessment after they consent to participate and before randomization. The intervention period will last 12 weeks (approximately 1 week for the in-office intervention and 12 weeks for all components of the Quitline intervention- telephone counseling and habitrol patches). Follow-up assessments will be administered at 3, 6, 12, & 24 we"
238490|NCT01434290|B3|Baseline|Total|Total of all reporting groups
238491|NCT01434290|B2|Baseline|12 Fractions|51.6 Gy IMRT in 12 fractions over two and a half weeks
238492|NCT01434290|B1|Baseline|5 Fractions|36.25 Gy IMRT in 5 fractions over two and a half weeks
238493|NCT01434290|P2|Participant Flow|12 Fractions|51.6 Gy IMRT in 12 fractions over two and a half weeks
238494|NCT01434290|P1|Participant Flow|5 Fractions|36.25 Gy IMRT (intensity modulated radiation therapy) in 5 fractions over two and a half weeks
238495|NCT01434290|O2|Outcome|12 Fractions|51.6 Gy IMRT in 12 fractions over two and a half weeks
238496|NCT01434290|O1|Outcome|5 Fractions|36.25 Gy IMRT (intensity modulated radiation therapy) in 5 fractions over two and a half weeks
238497|NCT01434290|O2|Outcome|12 Fractions|51.6 Gy IMRT in 12 fractions over two and a half weeks
238498|NCT01434290|O1|Outcome|5 Fractions|36.25 Gy IMRT in 5 fractions over two and a half weeks
238499|NCT01434290|O2|Outcome|12 Fractions|51.6 Gy IMRT in 12 fractions over two and a half weeks
238500|NCT01434290|O1|Outcome|5 Fractions|36.25 Gy IMRT in 5 fractions over two and a half weeks
238501|NCT01434290|O2|Outcome|12 Fractions|51.6 Gy IMRT in 12 fractions over two and a half weeks
238502|NCT01434290|O1|Outcome|5 Fractions|36.25 Gy IMRT in 5 fractions over two and a half weeks
238503|NCT01434290|O2|Outcome|12 Fractions|51.6 Gy IMRT in 12 fractions over two and a half weeks
238504|NCT01434290|O1|Outcome|5 Fractions|36.25 Gy IMRT in 5 fractions over two and a half weeks
238505|NCT01434290|O2|Outcome|12 Fractions|51.6 Gy IMRT in 12 fractions over two and a half weeks
238506|NCT01434290|O1|Outcome|5 Fractions|36.25 Gy IMRT in 5 fractions over two and a half weeks
238507|NCT01434290|O2|Outcome|12 Fractions|51.6 Gy IMRT in 12 fractions over two and a half weeks
238508|NCT01434290|O1|Outcome|5 Fractions|36.25 Gy IMRT in 5 fractions over two and a half weeks
238509|NCT01434290|O2|Outcome|12 Fractions|51.6 Gy IMRT in 12 fractions over two and a half weeks
238510|NCT01434290|O1|Outcome|5 Fractions|36.25 Gy IMRT in 5 fractions over two and a half weeks
263469|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
238529|NCT01434121|B3|Baseline|Placebo|"Subject receives an infusion of saline~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238530|NCT01434121|B2|Baseline|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238531|NCT01434121|B1|Baseline|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238532|NCT01434121|P3|Participant Flow|Placebo|"Subject receives an infusion of saline~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238533|NCT01434121|P2|Participant Flow|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238534|NCT01434121|P1|Participant Flow|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238535|NCT01434121|O3|Outcome|Placebo|"Subject receives an infusion of saline~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238536|NCT01434121|O2|Outcome|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238537|NCT01434121|O1|Outcome|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238538|NCT01434121|O3|Outcome|Placebo|"Subject receives an infusion of saline~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238539|NCT01434121|O2|Outcome|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238540|NCT01434121|O1|Outcome|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238541|NCT01434121|O3|Outcome|Placebo|"Subject receives an infusion of saline~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238542|NCT01434121|O2|Outcome|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238543|NCT01434121|O1|Outcome|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238544|NCT01434121|O3|Outcome|Placebo|"Subject receives an infusion of saline~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238545|NCT01434121|O2|Outcome|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238546|NCT01434121|O1|Outcome|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238547|NCT01434121|O3|Outcome|Placebo|"Subject receives an infusion of saline~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238548|NCT01434121|O2|Outcome|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238549|NCT01434121|O1|Outcome|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238550|NCT01434121|O3|Outcome|Placebo|"Subject receives an infusion of saline~Placebo"
238551|NCT01434121|O2|Outcome|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C~Ascorbic Acid: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238552|NCT01434121|O1|Outcome|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C~Ascorbic Acid: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238553|NCT01434121|O3|Outcome|Placebo|"Subject receives an infusion of saline~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238554|NCT01434121|O2|Outcome|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238555|NCT01434121|O1|Outcome|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238556|NCT01434121|E3|Reported Event|Placebo|"Subject receives an infusion of saline~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238557|NCT01434121|E2|Reported Event|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238558|NCT01434121|E1|Reported Event|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
238559|NCT01434030|B1|Baseline|Behavioral Observer|Behavioral: This is a field study that will investigate behavioral events (e.g. meals, exercise) in T1DM and daily glucose patterns using an insulin pump, continuous glucose monitoring (CGM) data, and frequent SMBG tagged with behavioral markers (recent food and activity). From these data, a learning algorithm – behavioral observer - will be able to track over time key recurrent elements, such as wake-up time, meals, exercise, and daily patterns of risks for hypo- or hyperglycemia. In future controllers, behavioral observation such as this will be used to forecast upcoming routine events, enabling open-loop and closed-loop control algorithms to deal with the probabilistic patterns of patients’ self-treatment behavior.
238763|NCT01433081|E1|Reported Event|Magnesium Sulfate Infusion|Administration of magnesium suflate
238560|NCT01434030|P1|Participant Flow|Behavioral Observer|Focus group methodology was chosen to obtain qualitative and quantitative data on participants’ desire to use glucose advisory systems to manage their diabetes, their concerns about and desired features and functions of these systems, and their perceived confidence with behavioral event recording. At the outset of each interview, the personalized glucose advisory system (PGASystem) was described to participants as a system composed of a continuous glucose monitor (CGM) device and insulin pump, into which they would input daily information about their insulin, food, and physical activity. The system would then use their data to create personalized algorithms and advice about various aspects of their diabetes management, such as suggestions regarding bolus and basal rate dosing. The interview consisted of open-ended, multiple choice, and dichotomous questions.
238561|NCT01434030|O1|Outcome|Behavioral Observer|Behavioral: This is a field study that will investigate behavioral events (e.g. meals, exercise) in T1DM and daily glucose patterns using an insulin pump, continuous glucose monitoring (CGM) data, and frequent SMBG tagged with behavioral markers (recent food and activity). From these data, a learning algorithm – behavioral observer - will be able to track over time key recurrent elements, such as wake-up time, meals, exercise, and daily patterns of risks for hypo- or hyperglycemia. In future controllers, behavioral observation such as this will be used to forecast upcoming routine events, enabling open-loop and closed-loop control algorithms to deal with the probabilistic patterns of patients’ self-treatment behavior.
238562|NCT01434030|O1|Outcome|Behavioral Observer|Focus group methodology was chosen to obtain qualitative and quantitative data on participants’ desire to use glucose advisory systems to manage their diabetes, their concerns about and desired features and functions of these systems, and their perceived confidence with behavioral event recording. At the outset of each interview, the personalized glucose advisory system (PGASystem) was described to participants as a system composed of a continuous glucose monitor (CGM) device and insulin pump, into which they would input daily information about their insulin, food, and physical activity. The system would then use their data to create personalized algorithms and advice about various aspects of their diabetes management, such as suggestions regarding bolus and basal rate dosing. The interview consisted of open-ended, multiple choice, and dichotomous questions.
238563|NCT01434030|E1|Reported Event|Behavioral Observer|Behavioral: This is a field study that will investigate behavioral events (e.g. meals, exercise) in T1DM and daily glucose patterns using an insulin pump, continuous glucose monitoring (CGM) data, and frequent SMBG tagged with behavioral markers (recent food and activity). From these data, a learning algorithm – behavioral observer - will be able to track over time key recurrent elements, such as wake-up time, meals, exercise, and daily patterns of risks for hypo- or hyperglycemia. In future controllers, behavioral observation such as this will be used to forecast upcoming routine events, enabling open-loop and closed-loop control algorithms to deal with the probabilistic patterns of patients’ self-treatment behavior.
238564|NCT01433978|B3|Baseline|Total|Total of all reporting groups
238565|NCT01433978|B2|Baseline|Avatrombopag (Core Study)|Avatrombopag was administered orally as 5 mg, 10 mg, 20 mg, 30 mg or 40 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 20 mg avatrombopag, once daily and they were allowed to have their dose titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on their response to study drug.
238566|NCT01433978|B1|Baseline|Eltrombopag (Core Study)|Eltrombopag was administered orally as 25 mg, 50 mg, or 75 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 50 mg eltrombopag once daily and they were allowed to have their dose titrated up (maximum dose of 75 mg eltrombopag) or down (minimum dose of 25 mg eltrombopag) depending on their response to study drug.
238567|NCT01433978|P3|Participant Flow|Avatrombopag (Open-label Extension Phase)|Participants who met the eligibility requirements for the Open-label Extension (OLE) Phase or who discontinued the Core Study early because of lack of treatment effect were eligible to continue into the OLE Phase for up to 104 weeks of open-label avatrombopag therapy. Participants entering the OLE from the Core Study received a starting dose of open-label avatrombopag that was determined by the last dose of study drug at the End of Treatment (EOT) Visit (Visit 22) of the Core Study. Participants who discontinued the Core Study early because of lack of treatment effect and entered the OLE received open-label avatrombopag at a starting dose of 20 mg once daily of open-label avatrombopag.
238568|NCT01433978|P2|Participant Flow|Avatrombopag (Core Study)|Avatrombopag was administered orally as 5 mg, 10 mg, 20 mg, 30 mg or 40 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 20 mg avatrombopag, once daily and they were allowed to have their dose titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on their response to study drug.
238569|NCT01433978|P1|Participant Flow|Eltrombopag (Core Study)|Eltrombopag was administered orally as 25 mg, 50 mg, or 75 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 50 mg eltrombopag once daily and they were allowed to have their dose titrated up (maximum dose of 75 mg eltrombopag) or down (minimum dose of 25 mg eltrombopag) depending on their response to study drug.
238570|NCT01433978|O2|Outcome|Avatrombopag (Core Study)|Avatrombopag was administered orally as 5 mg, 10 mg, 20 mg, 30 mg or 40 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 20 mg avatrombopag, once daily and they were allowed to have their dose titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on their response to study drug.
238571|NCT01433978|O1|Outcome|Eltrombopag (Core Study)|Eltrombopag was administered orally as 25 mg, 50 mg, or 75 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 50 mg eltrombopag once daily and they were allowed to have their dose titrated up (maximum dose of 75 mg eltrombopag) or down (minimum dose of 25 mg eltrombopag) depending on their response to study drug.
238572|NCT01433978|E3|Reported Event|Avatrombopag (Extension Phase)|Participants who met the eligibility requirements for the Open-label Extension (OLE) Phase or who discontinued the Core Study early because of lack of treatment effect were eligible to continue into the OLE Phase for up to 104 weeks of open-label avatrombopag therapy. Participants entering the OLE from the Core Study received a starting dose of open-label avatrombopag that was determined by the last dose of study drug at the End of Treatment (EOT) Visit (Visit 22) of the Core Study. Participants who discontinued the Core Study early because of lack of treatment effect and entered the OLE received open-label avatrombopag at a starting dose of 20 mg once daily of open-label avatrombopag.
238764|NCT01433055|B3|Baseline|Total|Total of all reporting groups
238573|NCT01433978|E2|Reported Event|Avatrombopag (Core Study)|Avatrombopag was administered orally as 5 mg, 10 mg, 20 mg, 30 mg or 40 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 20 mg avatrombopag, once daily and they were allowed to have their dose titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on their response to study drug.
238574|NCT01433978|E1|Reported Event|Eltrombopag (Core Study)|Eltrombopag was administered orally as 25 mg, 50 mg, or 75 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 50 mg eltrombopag once daily and they were allowed to have their dose titrated up (maximum dose of 75 mg eltrombopag) or down (minimum dose of 25 mg eltrombopag) depending on their response to study drug.
238575|NCT01433913|B3|Baseline|Total|Total of all reporting groups
238576|NCT01433913|B2|Baseline|Arm II (Placebo)|Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets until the day before surgery) for 4-12 weeks.
238577|NCT01433913|B1|Baseline|Arm I (Metformin Hydrochloride)|Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg metformin tablets until the day before surgery) for 4-12 weeks.
238578|NCT01433913|P2|Participant Flow|Arm II (Placebo)|Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
238579|NCT01433913|P1|Participant Flow|Arm I (Metformin Hydrochloride)|Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
238580|NCT01433913|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
238581|NCT01433913|O1|Outcome|Arm I (Metformin Hydrochloride)|Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
238582|NCT01433913|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
238583|NCT01433913|O1|Outcome|Arm I (Metformin Hydrochloride)|Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
238584|NCT01433913|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
238585|NCT01433913|O1|Outcome|Arm I (Metformin Hydrochloride)|Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
238586|NCT01433913|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
238587|NCT01433913|O1|Outcome|Arm I (Metformin Hydrochloride)|Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
238588|NCT01433913|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
238589|NCT01433913|O1|Outcome|Arm I (Metformin Hydrochloride)|Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
238590|NCT01433913|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
238591|NCT01433913|O1|Outcome|Arm I (Metformin Hydrochloride)|Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
238592|NCT01433913|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
238593|NCT01433913|O1|Outcome|Arm I (Metformin Hydrochloride)|Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
238594|NCT01433913|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
238595|NCT01433913|O1|Outcome|Arm I (Metformin Hydrochloride)|Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
238596|NCT01433913|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
238852|NCT01432600|E4|Reported Event|D: Crossover Arm|Phase II: Participants who crossed over from Arm B to Arm D.
238597|NCT01433913|O1|Outcome|Arm I (Metformin Hydrochloride)|Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
238598|NCT01433913|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
238599|NCT01433913|O1|Outcome|Arm I (Metformin Hydrochloride)|Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
238600|NCT01433913|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
238601|NCT01433913|O1|Outcome|Arm I (Metformin Hydrochloride)|Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
238602|NCT01433913|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
238603|NCT01433913|O1|Outcome|Arm I (Metformin Hydrochloride)|Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
238604|NCT01433913|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
238605|NCT01433913|O1|Outcome|Arm I (Metformin Hydrochloride)|Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
238606|NCT01433913|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.
238607|NCT01433913|O1|Outcome|Arm I (Metformin Hydrochloride)|Patients receive extended-release metformin hydrochloride PO QD (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg metformin tablets daily until the day before surgery) for 4-12 weeks.
238608|NCT01433913|E2|Reported Event|Arm II (Placebo)|"Patients receive placebo PO QD for 4-12 weeks.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
238609|NCT01433913|E1|Reported Event|Arm I (Metformin Hydrochloride)|"Patients receive extended-release metformin hydrochloride PO QD for 4-12 weeks.~metformin hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
238610|NCT01433731|B5|Baseline|Total|Total of all reporting groups
238611|NCT01433731|B4|Baseline|SHAPE (SHP-141) 1.0% BID|SHAPE (SHP-141): topical gelled solution at 1.0% concentration twice daily
238612|NCT01433731|B3|Baseline|SHAPE (SHP-141) 0.5% BID|SHAPE (SHP-141): topical gelled solution at 0.5% concentration twice daily
238613|NCT01433731|B2|Baseline|SHAPE (SHP-141) 0.1% BID|SHAPE (SHP-141): topical gelled solution at 0.1% concentration twice daily
238614|NCT01433731|B1|Baseline|Placebo for SHAPE (SHP-141)|placebo for SHAPE (SHP-141): topical gel
238615|NCT01433731|P4|Participant Flow|SHAPE (SHP-141) 1.0% BID|SHAPE (SHP-141): topical gelled solution at 1.0% concentration twice daily
238616|NCT01433731|P3|Participant Flow|SHAPE (SHP-141) 0.5% BID|SHAPE (SHP-141): topical gelled solution at 0.5% concentration twice daily
238617|NCT01433731|P2|Participant Flow|SHAPE (SHP-141) 0.1% BID|SHAPE (SHP-141): topical gelled solution at 0.1% concentration twice daily
238618|NCT01433731|P1|Participant Flow|Placebo for SHAPE (SHP-141)|placebo for SHAPE (SHP-141): topical gelled solution
238619|NCT01433731|O2|Outcome|Placebo for SHAPE (SHP-141)|placebo for SHAPE (SHP-141): topical gel
238620|NCT01433731|O1|Outcome|SHAPE (SHP-141)|"Histone deacetylase inhibitor~SHAPE (SHP-141): topical gel"
238621|NCT01433731|E4|Reported Event|SHAPE (SHP-141) 1.0% BID|SHAPE (SHP-141): topical gelled solution at 1.0% concentration twice daily
238622|NCT01433731|E3|Reported Event|SHAPE (SHP-141) 0.5% BID|SHAPE (SHP-141): topical gelled solution at 0.5% concentration twice daily
238623|NCT01433731|E2|Reported Event|SHAPE (SHP-141) 0.1% BID|SHAPE (SHP-141): topical gelled solution at 0.1% concentration twice daily
238624|NCT01433731|E1|Reported Event|Placebo for SHAPE (SHP-141)|placebo for SHAPE (SHP-141): topical gelled solution
238625|NCT01433549|B1|Baseline|Overall|Lotrafilcon B and Senofilcon A worn in cross-over fashion as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
238626|NCT01433549|P2|Participant Flow|Senofilcon A / Lotrafilcon B|Senofilcon A worn first, with lotrafilcon B worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
238627|NCT01433549|P1|Participant Flow|Lotrafilcon B / Senofilcon A|Lotrafilcon B worn first, with senofilcon A worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
238628|NCT01433549|O2|Outcome|Senofilcon A|Senofilcon A worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
238629|NCT01433549|O1|Outcome|Lotrafilcon B|Lotrafilcon B worn worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
240060|NCT01429584|E1|Reported Event|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
238630|NCT01433549|O2|Outcome|Senofilcon A|Senofilcon A worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
238631|NCT01433549|O1|Outcome|Lotrafilcon B|Lotrafilcon B worn worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
238632|NCT01433549|E2|Reported Event|Senofilcon A|Senofilcon A worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
238633|NCT01433549|E1|Reported Event|Lotrafilcon B|Lotrafilcon B worn worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
238634|NCT01433471|B3|Baseline|Total|Total of all reporting groups
238635|NCT01433471|B2|Baseline|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
238636|NCT01433471|B1|Baseline|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
238637|NCT01433471|P2|Participant Flow|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
238638|NCT01433471|P1|Participant Flow|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
238639|NCT01433471|O2|Outcome|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
238640|NCT01433471|O1|Outcome|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
238641|NCT01433471|O2|Outcome|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
238642|NCT01433471|O1|Outcome|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
238643|NCT01433471|O2|Outcome|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
238644|NCT01433471|O1|Outcome|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
238645|NCT01433471|O2|Outcome|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
238646|NCT01433471|O1|Outcome|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
238647|NCT01433471|O2|Outcome|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
238648|NCT01433471|O1|Outcome|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
238649|NCT01433471|O2|Outcome|Placebo|
238650|NCT01433471|O1|Outcome|Trichuris Suis Ova|
238651|NCT01433471|E2|Reported Event|Placebo|
238652|NCT01433471|E1|Reported Event|Trichuris Suis Ova|
238653|NCT01433354|B1|Baseline|AFQ056|Participants from a previous AFQ056 study who entered the open-label extension study were administered AFQ056 capsules at a starting dose of 25 milligram (mg) twice daily (bid) and then titrated to 50 mg bid, 75 mg bid and 100 mg bid at weekly intervals.
238654|NCT01433354|P1|Participant Flow|AFQ056|Participants from a previous AFQ056 study who entered the open-label extension study were administered AFQ056 capsules at a starting dose of 25 milligram (mg) twice daily (bid) and then titrated to 50 mg bid, 75 mg bid and 100 mg bid at weekly intervals.
238655|NCT01433354|O6|Outcome|AFQ056 100 mg Bid|
238656|NCT01433354|O5|Outcome|AFQ056 75 mg Bid|
238657|NCT01433354|O4|Outcome|AFQ056 50 mg Bid|
238658|NCT01433354|O3|Outcome|AFQ056 25 mg Bid|
238659|NCT01433354|O2|Outcome|Prior to Ext. First Dose|
238660|NCT01433354|O1|Outcome|AFQ056|Total
238661|NCT01433354|E6|Reported Event|Total|Total
238662|NCT01433354|E5|Reported Event|AFQ056 100 mg Bid|AFQ056 100 mg bid
238663|NCT01433354|E4|Reported Event|AFQ056 75 mg Bid|AFQ056 75 mg bid
238664|NCT01433354|E3|Reported Event|AFQ056 50 mg Bid|AFQ056 50 mg bid
238665|NCT01433354|E2|Reported Event|AFQ056 25 mg Bid|AFQ056 25 mg bid
238666|NCT01433354|E1|Reported Event|Prior to Ext.First Dose|Prior to Ext.first dose
238667|NCT01433263|B3|Baseline|Total|Total of all reporting groups
238668|NCT01433263|B2|Baseline|Placebo / Late 30mg/kg BYM338|
238669|NCT01433263|B1|Baseline|30mg/kg BYM338|
238670|NCT01433263|P2|Participant Flow|Placebo / Late 30mg/kg BYM338|
238671|NCT01433263|P1|Participant Flow|30mg/kg BYM338|
238672|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
238673|NCT01433263|O1|Outcome|30mg/kg BYM338|
238674|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
238675|NCT01433263|O1|Outcome|30mg/kg BYM338|
238676|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
238677|NCT01433263|O1|Outcome|30mg/kg BYM338|
238700|NCT01433250|P2|Participant Flow|AIN Placebo/ AIN457 Extension|"Placebo in core study and AIN in extension study~(10 mg/kg iv every four weeks)"
238701|NCT01433250|P1|Participant Flow|AIN457 Core / AIN457 Extension|AIN in core study , continued AIN in extension study ( 10 mg/Kg iv every four weeks)
238702|NCT01433250|O2|Outcome|PBO/AIN|placebo first 24 weeks/ AIN extension for 52 weeks
238703|NCT01433250|O1|Outcome|AIN/AIN|AIN core 24 weeks/AIN extension 1 year
238704|NCT01433250|O2|Outcome|PBO/AIN|placebo first 24 weeks/ AIN extension for 52 weeks
238705|NCT01433250|O1|Outcome|AIN/AIN|AIN core 24 weeks/AIN extension 1 year
238706|NCT01433250|O2|Outcome|PBO/AIN|placebo first 24 weeks/ AIN extension for 52 weeks
238707|NCT01433250|O1|Outcome|AIN/AIN|AIN core 24 weeks/AIN extension 1 year
238708|NCT01433250|O2|Outcome|PBO/AIN|placebo first 24 weeks/ AIN extension for 52 weeks
238709|NCT01433250|O1|Outcome|AIN/AIN|AIN core 24 weeks/AIN extension 1 year
238710|NCT01433250|O2|Outcome|PBO/AIN|placebo first 24 weeks/ AIN extension for 52 weeks
238711|NCT01433250|O1|Outcome|AIN/AIN|AIN core 24 weeks/AIN extension 1 year
238712|NCT01433250|O2|Outcome|PBO/AIN|placebo first 24 weeks/ AIN extension for 52 weeks
238713|NCT01433250|O1|Outcome|AIN/AIN|AIN core 24 weeks/AIN extension 1 year
238714|NCT01433250|E2|Reported Event|AIN457(Core)/AIN457(Extension)|AIN457(core)/AIN457(extension)
238715|NCT01433250|E1|Reported Event|Placebo(Core)/AIN457(Extension)|Placebo(core)/AIN457(extension)
238716|NCT01433172|B4|Baseline|Total|Total of all reporting groups
238717|NCT01433172|B3|Baseline|Phase II Arm B Vaccinations|Arm B participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
238718|NCT01433172|B2|Baseline|Phase II Arm A Vaccinations|Arm A participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals.
238719|NCT01433172|B1|Baseline|Phase I Vaccinations|Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
238720|NCT01433172|P3|Participant Flow|Phase II Arm B GM.CD40L.CCL21 Vaccinations|Phase II Arm B: Participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals. Note on either Arms A and B: the use of steroid medication is to be avoided for 4 weeks before to the initiation of vaccine therapy and during the vaccine treatment period.
238721|NCT01433172|P2|Participant Flow|Phase II Arm A GM.CD40L Cells Vaccinations|Phase II Arm A: Participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals. Note on either Arms A and B: the use of steroid medication is to be avoided for 4 weeks before to the initiation of vaccine therapy and during the vaccine treatment period.
238722|NCT01433172|P1|Participant Flow|Phase I GM.CD40L.CCL21 Vaccinations|Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals. Note for the phase I portion: the use of steroid medication is to be avoided for 4 weeks prior to the initiation of vaccine therapy and during the vaccine treatment period.
238723|NCT01433172|O2|Outcome|Phase II Arm B GM.CD40L.CCL21 Vaccinations|Arm B participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
238724|NCT01433172|O1|Outcome|Phase II Arm A GM.CD40L Cells Vaccinations|Arm A participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals.
238725|NCT01433172|O2|Outcome|Phase II Arm B GM.CD40L.CCL21 Vaccinations|Arm B participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
238726|NCT01433172|O1|Outcome|Phase II Arm A GM.CD40L Cells Vaccinations|Arm A participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals.
238727|NCT01433172|O1|Outcome|Phase I GM.CD40L.CCL21 Vaccinations|Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
238728|NCT01433172|E3|Reported Event|Phase II Arm B GM.CD40L.CCL21 Vaccinations|Arm B participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
238729|NCT01433172|E2|Reported Event|Phase II Arm A GM.CD40L Vaccinations|Arm A participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals.
238730|NCT01433172|E1|Reported Event|Phase I GM.CD40L.CCL21 Vaccinations|Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
238731|NCT01433159|B3|Baseline|Total|Total of all reporting groups
238732|NCT01433159|B2|Baseline|Various Standard Care|Standard Care at each site other than Xenaderm Ointment or other BCT2-containing products
238733|NCT01433159|B1|Baseline|HP011-101|Xenaderm Ointment
238734|NCT01433159|P2|Participant Flow|Various Standard Care|Standard Care at each site other than Xenaderm Ointment or other BCT2-containing products
238735|NCT01433159|P1|Participant Flow|HP011-101|Xenaderm Ointment
238736|NCT01433159|O2|Outcome|Various Standard Care|Standard Care at each site other than Xenaderm Ointment or other BCT-containing products
238737|NCT01433159|O1|Outcome|HP011-101|Xenaderm Ointment
238738|NCT01433159|E2|Reported Event|Various Standard Care|Standard Care at each site other than Xenaderm Ointment or other BCT2-containing products
238739|NCT01433159|E1|Reported Event|HP011-101|Xenaderm Ointment
238740|NCT01433107|B3|Baseline|Total|Total of all reporting groups
238741|NCT01433107|B2|Baseline|Placebo|Drug
238742|NCT01433107|B1|Baseline|Terbinafine|Drug
238743|NCT01433107|P2|Participant Flow|Placebo|Drug
238744|NCT01433107|P1|Participant Flow|Terbinafine|Drug
238745|NCT01433107|O2|Outcome|Placebo|Drug
238746|NCT01433107|O1|Outcome|Terbinafine|Drug
238747|NCT01433107|O2|Outcome|Placebo|Drug
238748|NCT01433107|O1|Outcome|Terbinafine|Drug
238749|NCT01433107|O2|Outcome|Placebo|Drug
238750|NCT01433107|O1|Outcome|Terbinafine|Drug
238751|NCT01433107|E2|Reported Event|Placebo|Drug
238752|NCT01433107|E1|Reported Event|Terbinafine|Drug
238753|NCT01433081|B3|Baseline|Total|Total of all reporting groups
238754|NCT01433081|B2|Baseline|Placebo|.9 normal saline infusion
238755|NCT01433081|B1|Baseline|Magnesium Sulfate Infusion|Administration of magnesium suflate
238756|NCT01433081|P2|Participant Flow|Placebo|Normal saline infusion
238757|NCT01433081|P1|Participant Flow|Magnesium Sulfate Infusion|Administration of magnesium suflate
238765|NCT01433055|B2|Baseline|Sugar Pill|"Placebo: Placebo Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
238766|NCT01433055|B1|Baseline|Minocycline|"Minocycline: Minocycline Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
238767|NCT01433055|P2|Participant Flow|Sugar Pill|"Placebo: Placebo Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
238768|NCT01433055|P1|Participant Flow|Minocycline|"Minocycline: Minocycline Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
238769|NCT01433055|O2|Outcome|Sugar Pill|"Placebo: Placebo Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
238770|NCT01433055|O1|Outcome|Minocycline|"Minocycline: Minocycline Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
238771|NCT01433055|O2|Outcome|Sugar Pill|"Placebo: Placebo Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
238772|NCT01433055|O1|Outcome|Minocycline|"Minocycline: Minocycline Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
238773|NCT01433055|O2|Outcome|Sugar Pill|"Placebo: Placebo Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
238818|NCT01432756|B3|Baseline|Wait-list Control - Adolescent Participants|Adolescent wait-list control participants have parents who are in the wait-list control group. Their parents will not receive the intervention until after the 3-month follow-up assessment.
240061|NCT01429532|B4|Baseline|Total|Total of all reporting groups
238774|NCT01433055|O1|Outcome|Minocycline|"Minocycline: Minocycline Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
238775|NCT01433055|O2|Outcome|Sugar Pill|"Placebo: Placebo Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
238776|NCT01433055|O1|Outcome|Minocycline|"Minocycline: Minocycline Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
238777|NCT01433055|O2|Outcome|Sugar Pill|"Placebo: Placebo Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
238778|NCT01433055|O1|Outcome|Minocycline|"Minocycline: Minocycline Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
238779|NCT01433055|E2|Reported Event|Sugar Pill|"Placebo: Placebo Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
238780|NCT01433055|E1|Reported Event|Minocycline|"Minocycline: Minocycline Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
238781|NCT01433042|B1|Baseline|Capsule Endoscopy|capsule endoscopy : capsule endoscopy procedure
238782|NCT01433042|P1|Participant Flow|Capsule Endoscopy|capsule endoscopy : capsule endoscopy procedure
238783|NCT01433042|O1|Outcome|Capsule Endoscopy|capsule endoscopy : capsule endoscopy procedure
238784|NCT01433042|E1|Reported Event|Capsule Endoscopy|capsule endoscopy : capsule endoscopy procedure
238785|NCT01433016|B1|Baseline|Suspected HCC|Subjects at high risk for hepatocellular carcinoma (HCC), such as cirrhotics and patients with advanced liver disease will be asked to perform a single Octanoate Breath test, where their breath will be analyzed before and after ingestion of 100 milligrams of Octanoate dissolved in a cup of tap water. The actual breath test procedure lasts approximately one hour.
238786|NCT01433016|P1|Participant Flow|Suspected HCC|Subjects at high risk for hepatocellular carcinoma (HCC), such as cirrhotics and patients with advanced liver disease will be asked to perform a single Octanoate Breath test, where their breath will be analyzed before and after ingestion of 100 milligrams of Octanoate dissolved in a cup of tap water. The actual breath test procedure lasts approximately one hour.
238787|NCT01433016|O1|Outcome|Suspected HCC|Subjects at high risk for Hepatocellular carcinoma (HCC), such as cirrhotics and patients with advanced liver disease
238788|NCT01433016|E1|Reported Event|Suspected HCC|Subjects at high risk for Hepatocellular carcinoma (HCC), such as cirrhotics and patients with advanced liver disease
238789|NCT01432938|B1|Baseline|Entire Study Population|Participants who received at least one dose of study drug (dulaglutide or warfarin).
239176|NCT01431703|B1|Baseline|NBI With Magnification|Patients with lesions diagnosed by Sano classification using NBI with magnification
238790|NCT01432938|P2|Participant Flow|Dulaglutide + Warfarin First, Then Warfarin|"First Intervention: A single, 1.5-mg subcutaneous dose of dulaglutide on Day 1, followed by a single, 10-mg dose of warfarin administered orally on Day 3 (Treatment 2).~There was a washout period of at least 24 days between intervention periods.~Second Intervention: A single, 10-mg dose of warfarin administered orally on Day 1 (Treatment 1)."
238791|NCT01432938|P1|Participant Flow|Warfarin First, Then Dulaglutide + Warfarin|"First Intervention: A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 (Treatment 1).~There was a washout period of at least 24 days between treatment periods.~Second Intervention: A single, 1.5-mg subcutaneous dose of dulaglutide on Day 1, followed by a single, 10-mg dose of warfarin administered orally on Day 3 (Treatment 2)."
238792|NCT01432938|O2|Outcome|Dulaglutide + Warfarin|A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2.
238793|NCT01432938|O1|Outcome|Warfarin Alone|A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 of Treatment 1.
238794|NCT01432938|O2|Outcome|Dulaglutide + Warfarin|A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2.
238795|NCT01432938|O1|Outcome|Warfarin Alone|A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 of Treatment 1.
238796|NCT01432938|O2|Outcome|Dulaglutide + Warfarin|A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2.
238797|NCT01432938|O1|Outcome|Warfarin Alone|A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 of Treatment 1.
238798|NCT01432938|O2|Outcome|Dulaglutide + Warfarin|A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2.
238799|NCT01432938|O1|Outcome|Warfarin Alone|A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 of Treatment 1.
238800|NCT01432938|O2|Outcome|Dulaglutide + Warfarin|A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2.
238801|NCT01432938|O1|Outcome|Warfarin Alone|A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 of Treatment 1.
238802|NCT01432938|E3|Reported Event|Dulaglutide + Warfarin|"A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2~Timeframe: After dosing of warfarin on Day 3 of Treatment 2"
238803|NCT01432938|E2|Reported Event|Dulaglutide Alone|"A single, 1.5-mg dose administered subcutaneously on Day 1 of Treatment 2.~Timeframe: Day 1 to Day 3 before dosing of warfarin in Treatment 2"
238804|NCT01432938|E1|Reported Event|Warfarin Alone|"A single, 10-milligram (mg) dose administered orally on Day 1 of Treatment 1.~Timeframe: Treatment 1"
238805|NCT01432886|B3|Baseline|Total|Total of all reporting groups
238806|NCT01432886|B2|Baseline|E7389 With Tri-weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
238807|NCT01432886|B1|Baseline|E7389 With Weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
238808|NCT01432886|P2|Participant Flow|E7389 With Tri-weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
238809|NCT01432886|P1|Participant Flow|E7389 With Weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
238810|NCT01432886|O2|Outcome|E7389 With Triweekly Trastuzumab|"Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle.~Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses."
238811|NCT01432886|O1|Outcome|E7389 With Weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
238812|NCT01432886|O2|Outcome|E7389 With Tri-weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
238813|NCT01432886|O1|Outcome|E7389 With Weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
238814|NCT01432886|E2|Reported Event|E7389 With Tri-weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
238815|NCT01432886|E1|Reported Event|E7389 With Weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
238816|NCT01432756|B5|Baseline|Total|Total of all reporting groups
238817|NCT01432756|B4|Baseline|Let's Talk Worksite Parenting Program -Adolescent Participants|"Adolescent participants will have parents who are in the Let's Talk Worksite Parenting Program.~The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child."
238819|NCT01432756|B2|Baseline|Let's Talk Worskite Parenting Program - Parent Participants|"The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child.~Let's Talk Worksite Parenting Program: The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence;"
238820|NCT01432756|B1|Baseline|Wait-list Control - Parent Participants|Participants in the wait-list control group will not receive the intervention until after the 3-month follow-up assessment.
238821|NCT01432756|P4|Participant Flow|Let's Talk Worksite Parenting Program - Adolescent Participant|"Adolescent participants will have parents who are in the Let's Talk Worksite Parenting Program.~The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child."
238822|NCT01432756|P3|Participant Flow|Wait-list Control - Adolescent Partipants|Adolescent wait-list control participants have parents who are in the wait-list control group. Their parents will not receive the intervention until after the 3-month follow-up assessment.
238823|NCT01432756|P2|Participant Flow|Let's Talk Worskite Parenting Program - Parent Participants|"The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child.~Let's Talk Worksite Parenting Program: The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence;"
238824|NCT01432756|P1|Participant Flow|Wait-list Control - Parent Participants|Parent participants in the wait-list control group will not receive the intervention until after the 3-month follow-up assessment.
238825|NCT01432756|O4|Outcome|Let's Talk Worksite Parenting Program -Adolescent Participants|"Adolescent participants will have parents who are in the Let's Talk Worksite Parenting Program.~The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child."
238826|NCT01432756|O3|Outcome|Wait-list Control - Adolescent Participants|Adolescent wait-list control participants have parents who are in the wait-list control group. Their parents will not receive the intervention until after the 3-month follow-up assessment.
238827|NCT01432756|O2|Outcome|Let's Talk Worskite Parenting Program - Parent Participants|"The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child.~Let's Talk Worksite Parenting Program: The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence;"
238828|NCT01432756|O1|Outcome|Wait-list Control - Parent Participants|Parent participants in the wait-list control group will not receive the intervention until after the 3-month follow-up assessment.
238829|NCT01432756|E2|Reported Event|Let's Talk Worskite Parenting Program|"The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child.~Let's Talk Worksite Parenting Program: The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence;"
238830|NCT01432756|E1|Reported Event|Wait-list Control|Participants in the wait-list control group will not receive the intervention until after the 3-month follow-up assessment.
238850|NCT01432600|O1|Outcome|B: Pomalidomide and Dexamethasone|"Phase II: Pomalidomide and high dose dexamethasone.~Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.~Arm D participants may be referenced separately in some Outcome Measures."
238851|NCT01432600|O1|Outcome|A: Dose Escalation of Cyclophosphamide|Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.
238831|NCT01432626|B1|Baseline|Stress Induced Cardiomyopathy Patients|"Patients with stress induced cardiomyopathy, by the Mayo criteria (normal coronary anatomy, EKG changes/Enzyme abnormalities, wall motion abnormalities consistent with stress induced cardiomyopathy and no evidence of pheochromocytoma) and signing informed consent, will receive an I123-mIBG scan to determine the sympathetic function of the heart during the acute presentation and after functional recovery.~I-123 radiolabeled metaiodobenzylguanidine cardiac imaging: All subjects will receive an intravenous injection of 10 mCi (370 MBq) of 123I-mIBG. A ±10% tolerance of the nominal dose will be allowed, thus yielding an acceptable dose range of 9 to 11 mCi (333 to 407 MBq). The patient will have planar and SPECT imaging performed after the dose is administered. This dosing and imaging procedure will be performed during the acute phase and after the patient has recovered cardiac function, approximately 6 weeks later."
238832|NCT01432626|P1|Participant Flow|Stress Induced Cardiomyopathy Patients|"Patients with stress induced cardiomyopathy, by the Mayo criteria (normal coronary anatomy, EKG changes/Enzyme abnormalities, wall motion abnormalities consistent with stress induced cardiomyopathy and no evidence of pheochromocytoma) and signing informed consent, will receive an I123-mIBG scan to determine the sympathetic function of the heart during the acute presentation and after functional recovery.~I-123 radiolabeled metaiodobenzylguanidine cardiac imaging: All subjects will receive an intravenous injection of 10 mCi (370 MBq) of 123I-mIBG. A ±10% tolerance of the nominal dose will be allowed, thus yielding an acceptable dose range of 9 to 11 mCi (333 to 407 MBq). The patient will have planar and SPECT imaging performed after the dose is administered. This dosing and imaging procedure will be performed during the acute phase and after the patient has recovered cardiac function, approximately 6 weeks later."
238833|NCT01432626|O1|Outcome|Stress Induced Cardiomyopathy Patients|"Patients with stress induced cardiomyopathy, by the Mayo criteria (normal coronary anatomy, EKG changes/Enzyme abnormalities, wall motion abnormalities consistent with stress induced cardiomyopathy and no evidence of pheochromocytoma) and signing informed consent, will receive an I123-mIBG scan to determine the sympathetic function of the heart during the acute presentation and after functional recovery.~I-123 radiolabeled metaiodobenzylguanidine cardiac imaging: All subjects will receive an intravenous injection of 10 mCi (370 MBq) of 123I-mIBG. A ±10% tolerance of the nominal dose will be allowed, thus yielding an acceptable dose range of 9 to 11 mCi (333 to 407 MBq). The patient will have planar and SPECT imaging performed after the dose is administered. This dosing and imaging procedure will be performed during the acute phase and after the patient has recovered cardiac function, approximately 6 weeks later."
238834|NCT01432626|E1|Reported Event|Stress Induced Cardiomyopathy Patients|"Patients with stress induced cardiomyopathy, by the Mayo criteria (normal coronary anatomy, EKG changes/Enzyme abnormalities, wall motion abnormalities consistent with stress induced cardiomyopathy and no evidence of pheochromocytoma) and signing informed consent, will receive an I123-mIBG scan to determine the sympathetic function of the heart during the acute presentation and after functional recovery.~I-123 radiolabeled metaiodobenzylguanidine cardiac imaging: All subjects will receive an intravenous injection of 10 mCi (370 MBq) of 123I-mIBG. A ±10% tolerance of the nominal dose will be allowed, thus yielding an acceptable dose range of 9 to 11 mCi (333 to 407 MBq). The patient will have planar and SPECT imaging performed after the dose is administered. This dosing and imaging procedure will be performed during the acute phase and after the patient has recovered cardiac function, approximately 6 weeks later."
238835|NCT01432600|B4|Baseline|Total|Total of all reporting groups
238836|NCT01432600|B3|Baseline|C: Pomalidomide, Dexamethasone, Cyclophosphamide|Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
238837|NCT01432600|B2|Baseline|B: Pomalidomide and Dexamethasone|"Phase II: Pomalidomide and high dose dexamethasone.~Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.~Arm D participants may be referenced separately in some Outcome Measures."
238838|NCT01432600|B1|Baseline|A: Dose Escalation of Cyclophosphamide|Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.
238839|NCT01432600|P3|Participant Flow|C: Pomalidomide, Dexamethasone, Cyclophosphamide|Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
238840|NCT01432600|P2|Participant Flow|B: Pomalidomide and Dexamethasone|"Phase II: Pomalidomide and high dose dexamethasone.~Arm D participants may be referenced separately in some Outcome Measures."
238841|NCT01432600|P1|Participant Flow|A: Dose Escalation of Cyclophosphamide|Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.
238842|NCT01432600|O3|Outcome|D: Crossover Arm|Phase II: Participants who crossed over from Arm B to Arm D. Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.
238843|NCT01432600|O2|Outcome|C: Pomalidomide, Dexamethasone, Cyclophosphamide|Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
238844|NCT01432600|O1|Outcome|B: Pomalidomide and Dexamethasone|"Phase II: Pomalidomide and high dose dexamethasone.~Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.~Arm D participants may be referenced separately in some Outcome Measures."
238845|NCT01432600|O2|Outcome|C: Pomalidomide, Dexamethasone, Cyclophosphamide|Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
238846|NCT01432600|O1|Outcome|B: Pomalidomide and Dexamethasone|"Phase II: Pomalidomide and high dose dexamethasone.~Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.~Arm D participants may be referenced separately in some Outcome Measures."
238847|NCT01432600|O2|Outcome|C: Pomalidomide, Dexamethasone, Cyclophosphamide|Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
238848|NCT01432600|O1|Outcome|B: Pomalidomide and Dexamethasone|"Phase II: Pomalidomide and high dose dexamethasone.~Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.~Arm D participants may be referenced separately in some Outcome Measures."
238849|NCT01432600|O2|Outcome|C: Pomalidomide, Dexamethasone, Cyclophosphamide|Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
238853|NCT01432600|E3|Reported Event|C: Pomalidomide, Dexamethasone, Cyclophosphamide|Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
238854|NCT01432600|E2|Reported Event|B: Pomalidomide and Dexamethasone|"Phase II: Pomalidomide and high dose dexamethasone.~Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.~Arm D participants may be referenced separately in some Outcome Measures."
238855|NCT01432600|E1|Reported Event|A: Dose Escalation of Cyclophosphamide|Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.
238856|NCT01432574|B1|Baseline|Gardasil Vaccine|"Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.~Gardasil: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3)."
238857|NCT01432574|P1|Participant Flow|Gardasil Vaccine|"Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.~Gardasil: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3)."
238858|NCT01432574|O2|Outcome|Gardasil Vaccine - Month 7|"Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.~Gardasil: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3)."
238859|NCT01432574|O1|Outcome|Gardasil Vaccine - Day 1|"Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.~Gardasil: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3)."
238860|NCT01432574|O1|Outcome|Gardasil Vaccine - Month 7|
238861|NCT01432574|E1|Reported Event|Gardasil Vaccine|"Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.~Gardasil: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3)."
238862|NCT01432561|B1|Baseline|Cysteamine Bitartrate|"Cysteamine bitartrate, 500mg once a day, three days.~Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4 which must occur within a 14 day period."
238863|NCT01432561|P1|Participant Flow|Cysteamine Bitartrate|"Cysteamine bitartrate, 500mg once a day, three days.~Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4 which must occur within a 14 day period."
238864|NCT01432561|O1|Outcome|Cysteamine Bitartrate|Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4
238865|NCT01432561|O1|Outcome|Cysteamine Bitartrate|Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4
238866|NCT01432561|O1|Outcome|Cysteamine Bitartrate|Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4
238867|NCT01432561|E1|Reported Event|Cysteamine Bitartrate|"Cysteamine bitartrate, 500mg once a day, three days.~Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4 which must occur within a 14 day period."
238868|NCT01432535|B4|Baseline|Total|Total of all reporting groups
238869|NCT01432535|B3|Baseline|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238870|NCT01432535|B2|Baseline|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238871|NCT01432535|B1|Baseline|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238872|NCT01432535|P3|Participant Flow|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238873|NCT01432535|P2|Participant Flow|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238874|NCT01432535|P1|Participant Flow|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238875|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238876|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238877|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238878|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238879|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238880|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238908|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
239247|NCT01431300|O1|Outcome|0.01 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
238881|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238882|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238883|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238884|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238885|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238886|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238887|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238888|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238889|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238890|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238891|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238892|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238893|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238894|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238895|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238896|NCT01432535|E3|Reported Event|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238897|NCT01432535|E2|Reported Event|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238898|NCT01432535|E1|Reported Event|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
238899|NCT01432457|B4|Baseline|Total|Total of all reporting groups
238900|NCT01432457|B3|Baseline|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
238901|NCT01432457|B2|Baseline|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
238902|NCT01432457|B1|Baseline|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
238903|NCT01432457|P3|Participant Flow|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
238904|NCT01432457|P2|Participant Flow|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
238905|NCT01432457|P1|Participant Flow|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
238906|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
238907|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
239289|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
238909|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
238910|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
238911|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
238912|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
238913|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
238914|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
238915|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
238916|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
238917|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
238918|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
238919|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
238920|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
238921|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
238922|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
238923|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
238924|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
238925|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
238926|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
238927|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
238928|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
238929|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
238930|NCT01432457|E3|Reported Event|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
238931|NCT01432457|E2|Reported Event|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
238932|NCT01432457|E1|Reported Event|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
238933|NCT01432444|B1|Baseline|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
238934|NCT01432444|P3|Participant Flow|Extension Phase (Phase C)|Participants who completed the 24-Week treatment period (Phase B), and whom the study physician believes would receive benefit from continued treatment with aripiprazole IM depot, were eligible to enter Phase C. During Phase C, participants were to continue treatment with aripiprazole IM depot until approximately 400 subjects have enrolled in Phase B (in order to achieve approximately 200 Phase B completers).
240062|NCT01429532|B3|Baseline|Group III|3.0-mm-incision-size phacoemulsification system
238935|NCT01432444|P2|Participant Flow|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
238936|NCT01432444|P1|Participant Flow|Tolerability/Cross-titration Phase (Phase A)|In Phase A, participants who had no history of tolerating oral aripiprazole entered a Tolerability Assessment/Cross-titration Phase in order to assess tolerability to oral aripiprazole. The recommended initial dose of oral aripiprazole in the Tolerability Assessment/Cross-titration Phase was 10 mg or 15 mg/day, depending on the participant's symptoms and the study physician's judgment. Participants were seen in the clinic at baseline and weekly thereafter for a minimum of 1 week and maximum of 4 weeks/28 days, until tolerability to oral aripiprazole had been determined, based on physician's discretion, or until the participant was terminated from the study.
238937|NCT01432444|O1|Outcome|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
238938|NCT01432444|O1|Outcome|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
238939|NCT01432444|O1|Outcome|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
238940|NCT01432444|O1|Outcome|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
238941|NCT01432444|O1|Outcome|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
238942|NCT01432444|O1|Outcome|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
238943|NCT01432444|E2|Reported Event|Extension Phase (Phase C)|Participants who completed the 24-Week treatment period (Phase B), and whom the study physician believed would benefit from continued treatment with aripiprazole IM depot, were eligible to enter Phase C. During Phase C, participants were to continue treatment with aripiprazole IM depot until approximately 400 subjects have enrolled in Phase B (in order to achieve approximately 200 Phase B completers).
238944|NCT01432444|E1|Reported Event|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
238945|NCT01432405|B3|Baseline|Total|Total of all reporting groups
238976|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
238946|NCT01432405|B2|Baseline|Pioglitazone|"Pioglitazone 45 mg daily orally for 12 months~Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
238947|NCT01432405|B1|Baseline|Pioglitazone and Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months.~Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
238948|NCT01432405|P2|Participant Flow|Pioglitazone|"Pioglitazone 45 mg daily orally for 12 months~Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
238949|NCT01432405|P1|Participant Flow|Pioglitazone and Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months.~Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
238950|NCT01432405|O2|Outcome|Pioglitazone|"Pioglitazone 45 mg daily orally for 12 months~Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
238951|NCT01432405|O1|Outcome|Pioglitazone and Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months.~Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
238952|NCT01432405|O2|Outcome|Pioglitazone|"Pioglitazone 45 mg daily orally for 12 months~Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
238953|NCT01432405|O1|Outcome|Pioglitazone and Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months.~Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
238954|NCT01432405|E2|Reported Event|Pioglitazone|"Pioglitazone 45 mg daily orally for 12 months~Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
238977|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
263470|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
238955|NCT01432405|E1|Reported Event|Pioglitazone and Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months.~Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
238956|NCT01432379|B1|Baseline|Botulinum Toxin Type A|155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
238957|NCT01432379|P1|Participant Flow|Botulinum Toxin Type A|155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
238958|NCT01432379|O1|Outcome|Botulinum Toxin Type A|155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
238959|NCT01432379|O1|Outcome|Botulinum Toxin Type A|155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
238960|NCT01432379|E1|Reported Event|Botulinum Toxin Type A|155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
238961|NCT01432366|B1|Baseline|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
238962|NCT01432366|P1|Participant Flow|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
238963|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
238964|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
238965|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
238966|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
238967|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
238968|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
238969|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
238970|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
238971|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
238972|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
238973|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
238974|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
238975|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
240063|NCT01429532|B2|Baseline|Group II|2.2-mm-incision-size phacoemulsification system
238978|NCT01432366|E1|Reported Event|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
238979|NCT01432327|B5|Baseline|Total|Total of all reporting groups
238980|NCT01432327|B4|Baseline|Coaching Group|Participants receive real-time feedback on their energy expenditure, step count and minutes of physical activity by means of the SenseWear Display and weekly meet with a Personal Coach to discuss their progress
238981|NCT01432327|B3|Baseline|Display Group|Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display
238982|NCT01432327|B2|Baseline|Step Group|This group receives feedback about the daily amount of steps by means of a pedometer.
238983|NCT01432327|B1|Baseline|Control Group|This group receives no kind of feedback during the intervention period
238984|NCT01432327|P4|Participant Flow|Coaching Group|Participants receive real-time feedback on their energy expenditure, step count and minutes of physical activity by means of the SenseWear Display and weekly meet with a Personal Coach to discuss their progress
238985|NCT01432327|P3|Participant Flow|Display Group|Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display
238986|NCT01432327|P2|Participant Flow|Step Group|This group receives feedback about the daily amount of steps by means of a pedometer.
238987|NCT01432327|P1|Participant Flow|Control Group|This group receives no kind of feedback during the intervention period
238988|NCT01432327|O4|Outcome|Coaching Group|Participants receive real-time feedback on their energy expenditure, step count and minutes of physical activity by means of the SenseWear Display and weekly meet with a Personal Coach to discuss their progress
238989|NCT01432327|O3|Outcome|Display Group|Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display
238990|NCT01432327|O2|Outcome|Step Group|This group receives feedback about the daily amount of steps by means of a pedometer.
238991|NCT01432327|O1|Outcome|Control Group|This group receives no kind of feedback during the intervention period
238992|NCT01432327|E4|Reported Event|Coaching Group|Participants receive real-time feedback on their energy expenditure, step count and minutes of physical activity by means of the SenseWear Display and weekly meet with a Personal Coach to discuss their progress
238993|NCT01432327|E3|Reported Event|Display Group|Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display
238994|NCT01432327|E2|Reported Event|Step Group|This group receives feedback about the daily amount of steps by means of a pedometer.
238995|NCT01432327|E1|Reported Event|Control Group|This group receives no kind of feedback during the intervention period
238996|NCT01432275|B1|Baseline|Per Protocol Population|Subjects who completed the study.
238997|NCT01432275|P2|Participant Flow|Comparator, Then ADC, Then ADC With Calculator|Subject used a comparator blood glucose meter for 7 days, followed by the ADC blood glucose meter for 7 days, with the insulin calculator not activated. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active.
238998|NCT01432275|P1|Participant Flow|ADC, Then Comparator, Then ADC With Calculator|Subject used the ADC blood glucose meter for 7 days with the insulin calculator not activated, followed by a comparator blood glucose meter for 7 days. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active.
238999|NCT01432275|O1|Outcome|Per Protocol Population|Subjects completing the study using the FreeStyle InsuLinx Blood Glucose Meter and one of the comparator blood glucose meters
239000|NCT01432275|O1|Outcome|Per Protocol Population|Subjects completing the study using the FreeStyle InsuLinx Blood Glucose Meter and one of the comparator blood glucose meters
239001|NCT01432275|E3|Reported Event|ADC Blood Glucose Meter With Calculator|ADC blood glucose meter for 10 days with the insulin calculator active.
239002|NCT01432275|E2|Reported Event|Comparator Blood Glucose Meter|Comparator blood glucose meter for 7 days.
239003|NCT01432275|E1|Reported Event|ADC Blood Glucose Meter|ADC blood glucose meter for 7 days with the insulin calculator not activated.
239004|NCT01432262|B3|Baseline|Total|Total of all reporting groups
239005|NCT01432262|B2|Baseline|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
239006|NCT01432262|B1|Baseline|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
239007|NCT01432262|P2|Participant Flow|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
239008|NCT01432262|P1|Participant Flow|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
239009|NCT01432262|O2|Outcome|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
239010|NCT01432262|O1|Outcome|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
239011|NCT01432262|O2|Outcome|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
239012|NCT01432262|O1|Outcome|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
239013|NCT01432262|O2|Outcome|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
239014|NCT01432262|O1|Outcome|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
263471|NCT01349816|E6|Reported Event|FF MDI 9.6 µg|FF MDI 9.6 µg BID
239015|NCT01432262|O2|Outcome|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
239016|NCT01432262|O1|Outcome|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
239017|NCT01432262|O2|Outcome|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
239018|NCT01432262|O1|Outcome|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
239019|NCT01432262|O2|Outcome|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
239020|NCT01432262|O1|Outcome|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
239021|NCT01432262|E2|Reported Event|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
239022|NCT01432262|E1|Reported Event|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
239023|NCT01432236|B3|Baseline|Total|Total of all reporting groups
239024|NCT01432236|B2|Baseline|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239025|NCT01432236|B1|Baseline|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239026|NCT01432236|P2|Participant Flow|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239027|NCT01432236|P1|Participant Flow|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239028|NCT01432236|O1|Outcome|All Participants|All randomized participants were included in this analysis.
239029|NCT01432236|O1|Outcome|All Participants|All randomized participants were included in this analysis.
239030|NCT01432236|O1|Outcome|All Participants|All randomized participants were included in this analysis.
239031|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
239032|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239033|NCT01432236|O2|Outcome|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239034|NCT01432236|O1|Outcome|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239035|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
239099|NCT01431989|E2|Reported Event|Reference Product in Period 1 and Test Product in Period 2|Reference product: Amoxil 500 mg/5 mL in Period 1; followed by a 14-day washout period during which no medication was administered; followed by test product: Clamoxyl 500 mg/5 mL in Period 2
263472|NCT01349816|E5|Reported Event|GP MDI 36 µg|GP MDI 36 µg BID
239036|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239037|NCT01432236|O2|Outcome|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239038|NCT01432236|O1|Outcome|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239039|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
239040|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239041|NCT01432236|O2|Outcome|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239042|NCT01432236|O1|Outcome|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239043|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
239044|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239045|NCT01432236|O2|Outcome|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239046|NCT01432236|O1|Outcome|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239047|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
239059|NCT01432236|O2|Outcome|Placebo|This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239048|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239049|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
239050|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239051|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
239052|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239053|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
239054|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239055|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
239056|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239057|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
239058|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239094|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
239095|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
239096|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
239060|NCT01432236|O1|Outcome|Pregabalin|This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239061|NCT01432236|O2|Outcome|Placebo|This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
239062|NCT01432236|O1|Outcome|Pregabalin|This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239063|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
239064|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239065|NCT01432236|O2|Outcome|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process in period 2. There was a 2-week single-blind taper/washout period between treatment periods
239066|NCT01432236|O1|Outcome|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239067|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
239068|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239069|NCT01432236|E2|Reported Event|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
239070|NCT01432236|E1|Reported Event|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
239071|NCT01432015|B3|Baseline|Total|Total of all reporting groups
239072|NCT01432015|B2|Baseline|Aprepitant Including Placebo|"Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) with Intravenous Placebo and 80 mg orally once daily in the morning on Days 2 and 3 with Placebo Intravenously on day 1. patient will receive standard pre-medications on day 1.~aprepitant including placebo: Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications"
239097|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
239098|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
239177|NCT01431703|P1|Participant Flow|NBI With Magnification|Patients with lesions diagnosed by Sano classification using NBI with magnification
239073|NCT01432015|B1|Baseline|Fosaprepitant Including Placebo|"Fosaprepitant (EMEND™) for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy.Oral Placebo 125 mg given 1 hour prior to infusion of chemotherapy on day 1 and oral Placebo 80 mg on day 2 and day 3.Patient will receive standard pre-medications on day 1~Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3~fosaprepitant including placebo: Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Patient will receive standard pre-medications"
239074|NCT01432015|P2|Participant Flow|Aprepitant and Placebo|Aprepitant is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) with Intravenous Placebo on day 1 and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications on day 1.
239075|NCT01432015|P1|Participant Flow|Fosaprepitant and Placebo|Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy.Oral Placebo 125 mg given 1 hour prior to infusion of chemotherapy on day 1 and oral Placebo 80 mg on day 2 and day 3. Patient will receive standard pre-medications on day 1
239076|NCT01432015|O2|Outcome|Aprepitant Including Placebo|"Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) with Intravenous Placebo and 80 mg orally once daily in the morning on Days 2 and 3 with Placebo Intravenously on day 1. patient will receive standard pre-medications on day 1.~aprepitant including placebo: Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications"
239077|NCT01432015|O1|Outcome|Fosaprepitant Including Placebo|"Fosaprepitant (EMEND™) for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy.Oral Placebo 125 mg given 1 hour prior to infusion of chemotherapy on day 1 and oral Placebo 80 mg on day 2 and day 3.Patient will receive standard pre-medications on day 1~Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3~fosaprepitant including placebo: Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Patient will receive standard pre-medications"
239078|NCT01432015|O2|Outcome|Aprepitant Including Placebo|"Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) with Intravenous Placebo and 80 mg orally once daily in the morning on Days 2 and 3 with Placebo Intravenously on day 1. patient will receive standard pre-medications on day 1.~aprepitant including placebo: Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications"
239079|NCT01432015|O1|Outcome|Fosaprepitant Including Placebo|"Fosaprepitant (EMEND™) for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy.Oral Placebo 125 mg given 1 hour prior to infusion of chemotherapy on day 1 and oral Placebo 80 mg on day 2 and day 3.Patient will receive standard pre-medications on day 1~Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3~fosaprepitant including placebo: Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Patient will receive standard pre-medications"
239080|NCT01432015|E2|Reported Event|Aprepitant and Placebo|Aprepitant is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) with Intravenous Placebo on day 1 and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications on day 1.
239081|NCT01432015|E1|Reported Event|Fosaprepitant and Placebo|Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy.Oral Placebo 125 mg given 1 hour prior to infusion of chemotherapy on day 1 and oral Placebo 80 mg on day 2 and day 3.Patient will receive standard pre-medications on day 1
239082|NCT01431989|B1|Baseline|Participants Receiving Both Test and Reference Products|Participants receiving either test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, in Period 1; followed by a 14-day washout period during which no medication was administered; followed by reference product, Amoxil 500 mg/5 mL powder for oral suspension, in Period 2 or reference product in Period 1 and test product inPeriod 2
239083|NCT01431989|P2|Participant Flow|Reference Product in Period 1: Test Product in Period 2|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, in Period 1; followed by a 14-day washout period during which no medication was administered; followed by test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, in Period 2
239084|NCT01431989|P1|Participant Flow|Test Product in Period 1: Reference Product in Period 2|Test product, Amoxicillin (Clamoxyl) 500 milligrams (mg)/5 milliliter (mL) powder for oral suspension, in Period 1; followed by a 14-day washout period during which no medication was administered; followed by reference product, Amoxil 500 mg/5 mL powder for oral suspension, in Period 2
239085|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
239086|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
239087|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
239088|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
239089|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
239090|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
239091|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
239092|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
239093|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
239100|NCT01431989|E1|Reported Event|Test Product in Period 1 and Reference Product in Period 2|Test product: Amoxicillin powder for oral suspension (Clamoxyl) 500 mg/5 mL in Period 1; followed by a 14-day washout period during which no medication was administered; followed by reference product; Amoxil 50 mg/5 mL in Period 2
239101|NCT01431976|B1|Baseline|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
239102|NCT01431976|P1|Participant Flow|Lamotrigine|In the EP, lamotrigine 0.3 milligrams per kilogram per day (mg/kg/day) was administered orally once daily from Week W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, whichever was less (WWL), until a seizure-free (SF) status was confirmed by hyperventilation (HV)-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
239103|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
239104|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
239105|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
239106|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
239107|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
239150|NCT01431755|O1|Outcome|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
239178|NCT01431703|O1|Outcome|NBI With Magnification|Patients with lesions diagnosed by Sano classification using NBI with magnification
240064|NCT01429532|B1|Baseline|Group I|1.8-mm-incision-size phacoemulsification system
239108|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
239109|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
239110|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
239111|NCT01431976|E1|Reported Event|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at &gt;=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose &lt;1.2 mg/kg/day or &gt;10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
239112|NCT01431963|B1|Baseline|Lamotrigine|In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
239113|NCT01431963|P1|Participant Flow|Lamotrigine|In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
239114|NCT01431963|O1|Outcome|Lamotrigine|In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
239115|NCT01431963|O1|Outcome|Lamotrigine|In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
239116|NCT01431963|O1|Outcome|Lamotrigine|In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
239117|NCT01431963|E1|Reported Event|Lamotrigine|In the EP, lamotrigine 25 mg/day was orally administered QD; in the evening(PM) as the initial dose from W1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD(in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, Lamotrigine 200 mg/day was orally administered QD(PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at greater than or equal to 1 week intervals. A dose greater than 200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose less than 100 or greater than 400 mg/day was judged to be necessary, the participant was withdrawn from the study.
239118|NCT01431950|B3|Baseline|Total|Total of all reporting groups
239119|NCT01431950|B2|Baseline|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
239120|NCT01431950|B1|Baseline|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
239121|NCT01431950|P2|Participant Flow|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
239122|NCT01431950|P1|Participant Flow|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
239123|NCT01431950|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
239124|NCT01431950|O1|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
239125|NCT01431950|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
239126|NCT01431950|O1|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
239127|NCT01431950|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
239128|NCT01431950|O1|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
239129|NCT01431950|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
239130|NCT01431950|O1|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
239131|NCT01431950|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
239132|NCT01431950|O1|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
239133|NCT01431950|E2|Reported Event|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
239134|NCT01431950|E1|Reported Event|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
239135|NCT01431846|B4|Baseline|Total|Total of all reporting groups
239151|NCT01431755|O1|Outcome|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
239136|NCT01431846|B3|Baseline|Arm 3|"Informed by the interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1)PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention~Intervention: Informed by the interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1) PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical att"
239137|NCT01431846|B2|Baseline|Arm 2|Three providers who refer patients to the Denver VA Medical Center for cardiac care were interviewed to identify barriers and facilitators from their perspective of following-up with patients after their hospitalization at Denver VAMC. Additionally, the same information was asked of providers who participated in two focus groups in the Grand Junction VA.
239138|NCT01431846|B1|Baseline|Arm 1|Eight patients who were being discharged from Denver VA Medical Center for cardiac care to their primary care providers were recruited at the time of discharge and completed an interview two weeks following their discharge. Patients were asked to describe their transition to home and identify barriers and facilitators of this process, their understanding of their medical condition, new medications prescribed, timeliness of follow-up visit with their PCP and knowledge of signs/symptoms in which they should seek medical attention.
239139|NCT01431846|P3|Participant Flow|Arm 3|Informed by interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1)PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention Intervention: Informed by the interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1) PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention
239140|NCT01431846|P2|Participant Flow|Arm 2|Three providers who refer patients to the Denver VA Medical Center for cardiac care were interviewed to identify barriers and facilitators from their perspective of following-up with patients after their hospitalization at Denver VAMC. Additionally, the same information was asked of providers who participated in two focus groups in the Grand Junction VA.
239141|NCT01431846|P1|Participant Flow|Arm 1|Eight patients who were being discharged from Denver VA Medical Center for cardiac care to their primary care providers were recruited at the time of discharge and completed an interview two weeks following their discharge. Patients were asked to describe their transition to home and identify barriers and facilitators of this process, their understanding of their medical condition, new medications prescribed, timeliness of follow-up visit with their PCP and knowledge of signs/symptoms in which they should seek medical attention.
239142|NCT01431846|O3|Outcome|Arm 3|Informed by interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1)PCP follow-up within 2-4 weeks of hospital discharge; 2)medications reconciled between pre and post-hospital discharge; 3)discharge summary available to PCP at time of visit; and 4)patient awareness of symptoms that require medical attention Intervention: Informed by the interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1) PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention
239143|NCT01431846|O2|Outcome|Arm 2|Three providers who refer patients to the Denver VA Medical Center for cardiac care were interviewed to identify barriers and facilitators from their perspective of following-up with patients after their hospitalization at Denver VAMC. Additionally, the same information was asked of providers who participated in two focus groups in the Grand Junction VA.
239144|NCT01431846|O1|Outcome|Arm 1|Eight patients who were being discharged from Denver VA Medical Center for cardiac care to their primary care providers were recruited at the time of discharge and completed an interview two weeks following their discharge. Patients were asked to describe their transition to home and identify barriers and facilitators of this process, their understanding of their medical condition, new medications prescribed, timeliness of follow-up visit with their PCP and knowledge of signs/symptoms in which they should seek medical attention.
239145|NCT01431846|E3|Reported Event|Intervention|Total number at risk was 8. Zero adverse events were seen.
239146|NCT01431846|E2|Reported Event|Providers|Total number at risk was 3. Zero adverse events were seen.
239147|NCT01431846|E1|Reported Event|Discharged Patients|Total number at risk was 8. Zero adverse events were seen.
239148|NCT01431755|B1|Baseline|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended
239149|NCT01431755|P1|Participant Flow|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
240065|NCT01429532|P3|Participant Flow|Group III|3.0-mm-incision-size phacoemulsification system
239152|NCT01431755|O1|Outcome|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
239153|NCT01431755|O1|Outcome|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
239154|NCT01431755|O1|Outcome|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
239155|NCT01431755|O1|Outcome|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
239156|NCT01431755|E3|Reported Event|Restylane SubQ Lidocaine: Localized|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.Hence, all subjects received injections with both products at the same time
239157|NCT01431755|E2|Reported Event|Restylane SubQ: Localized|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.Hence, all subjects received injections with both products at the same time
239158|NCT01431755|E1|Reported Event|Restylane SubQ/Restylane SubQ Lidocaine: Systemic|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.Hence, all subjects received injections with both products at the same time.
239159|NCT01431716|B1|Baseline|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
239160|NCT01431716|P1|Participant Flow|Epoprostenol for Injection (EFI/ACT-385781A)|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
239161|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
239162|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
239163|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
239164|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
239165|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
239166|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
239167|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
239168|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
239169|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
239170|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
239171|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
239172|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
239173|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
239174|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
239175|NCT01431716|E1|Reported Event|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
239179|NCT01431703|E1|Reported Event|NBI With Magnification|Patients with lesions diagnosed by Sano classification using NBI with magnification
239180|NCT01431521|B5|Baseline|Total|Total of all reporting groups
239181|NCT01431521|B4|Baseline|Placebo for Pioglitazone|Participants will receive oral doses of placebo to match pioglitazone hydrochloride once daily for 4 weeks.
239182|NCT01431521|B3|Baseline|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
239183|NCT01431521|B2|Baseline|Placebo for MK-4074|Participants will receive oral doses of placebo to match MK-4074 twice daily for 4 weeks.
239184|NCT01431521|B1|Baseline|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
239185|NCT01431521|P4|Participant Flow|Placebo for Pioglitazone|Participants will receive oral doses of placebo to match pioglitazone hydrochloride once daily for 4 weeks.
239186|NCT01431521|P3|Participant Flow|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
239187|NCT01431521|P2|Participant Flow|Placebo for MK-4074|Participants will receive oral doses of placebo to match MK-4074 twice daily for 4 weeks.
239188|NCT01431521|P1|Participant Flow|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
239189|NCT01431521|O3|Outcome|Placebo|Participants will receive oral doses of placebo to match MK-4074 or pioglitazone hydrochloride once daily for 4 weeks.
239190|NCT01431521|O2|Outcome|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
239191|NCT01431521|O1|Outcome|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
239192|NCT01431521|O3|Outcome|Placebo|Participants will receive oral doses of placebo to match MK-4074 or pioglitazone hydrochloride once daily for 4 weeks.
239193|NCT01431521|O2|Outcome|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
239194|NCT01431521|O1|Outcome|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
239195|NCT01431521|O3|Outcome|Placebo|Participants will receive oral doses of placebo to match MK-4074 or pioglitazone hydrochloride once daily for 4 weeks.
239196|NCT01431521|O2|Outcome|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
239197|NCT01431521|O1|Outcome|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
239198|NCT01431521|O3|Outcome|Placebo|Participants will receive oral doses of placebo to match MK-4074 or pioglitazone hydrochloride once daily for 4 weeks.
239199|NCT01431521|O2|Outcome|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
239200|NCT01431521|O1|Outcome|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
239201|NCT01431521|O3|Outcome|Placebo|Participants will receive oral doses of placebo to match MK-4074 or pioglitazone hydrochloride once daily for 4 weeks.
239202|NCT01431521|O2|Outcome|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
239203|NCT01431521|O1|Outcome|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
239204|NCT01431521|E4|Reported Event|Placebo for Pioglitazone|Participants will receive oral doses of placebo to match pioglitazone hydrochloride once daily for 4 weeks.
239205|NCT01431521|E3|Reported Event|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg once daily for 4 weeks.
239206|NCT01431521|E2|Reported Event|Placebo for MK-4074|Participants will receive oral doses of placebo matching MK-4074 twice daily for 4 weeks.
239207|NCT01431521|E1|Reported Event|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
239208|NCT01431508|B1|Baseline|Losartan 50 mg / HCTZ 12.5 mg|Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / HCTZ 12.5 mg once-a-day for 12 weeks.
239209|NCT01431508|P1|Participant Flow|Losartan 50 mg / HCTZ 12.5 mg|Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg once-a-day for 12 weeks.
239210|NCT01431508|O1|Outcome|Losartan 50 mg / HCTZ 12.5 mg|Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg once-a-day for 12 weeks.
239211|NCT01431508|E1|Reported Event|Losartan 50 mg/HCTZ 12.5 mg|
239212|NCT01431391|B3|Baseline|Total|Total of all reporting groups
239213|NCT01431391|B2|Baseline|Arm 2: ADT Followed by Sipuleucel-T|Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
239214|NCT01431391|B1|Baseline|Arm 1: Sipuleucel-T Followed by ADT|Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
239215|NCT01431391|P2|Participant Flow|Arm 2: ADT Followed by Sipuleucel-T|Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
239245|NCT01431300|O3|Outcome|0.03 mmol/kg|"FDA-approved dose for lower extremity arterial imaging~gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent"
239246|NCT01431300|O2|Outcome|0.02 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
263545|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
239216|NCT01431391|P1|Participant Flow|Arm 1:Sipuleucel-T Followed by ADT|Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started androgen deprivation therapy (ADT) with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
239217|NCT01431391|O2|Outcome|Arm 2: ADT Followed by Sipuleucel-T|Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
239218|NCT01431391|O1|Outcome|Arm 1:Sipuleucel-T Followed by ADT|Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started androgen deprivation therapy (ADT) with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
239219|NCT01431391|O2|Outcome|Arm 2: ADT Followed by Sipuleucel-T|Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
239220|NCT01431391|O1|Outcome|Arm 1: Sipuleucel-T Followed by ADT|Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
239221|NCT01431391|E2|Reported Event|Arm 2: ADT Followed by Sipuleucel-T|Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
239222|NCT01431391|E1|Reported Event|Arm 1: Sipuleucel-T Followed by ADT|Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
239223|NCT01431339|B3|Baseline|Total|Total of all reporting groups
239224|NCT01431339|B2|Baseline|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
239225|NCT01431339|B1|Baseline|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
239226|NCT01431339|P2|Participant Flow|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
239227|NCT01431339|P1|Participant Flow|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
239228|NCT01431339|O2|Outcome|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
239229|NCT01431339|O1|Outcome|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
239230|NCT01431339|O2|Outcome|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
239231|NCT01431339|O1|Outcome|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
239232|NCT01431339|O2|Outcome|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
239233|NCT01431339|O1|Outcome|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
239234|NCT01431339|O2|Outcome|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
239235|NCT01431339|O1|Outcome|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
239236|NCT01431339|E2|Reported Event|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
239237|NCT01431339|E1|Reported Event|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
239238|NCT01431300|B4|Baseline|Total|Total of all reporting groups
239239|NCT01431300|B3|Baseline|0.03 mmol/kg|"FDA-approved dose for lower extremity arterial imaging~gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent"
239240|NCT01431300|B2|Baseline|0.02 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
239241|NCT01431300|B1|Baseline|0.01 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
239242|NCT01431300|P3|Participant Flow|0.03 mmol/kg of Gadofosveset|Intravenous administration of gadofosveset via power injector at onset of MRI image acquisition. This is the FDA-approved dose for lower extremity arterial imaging
239243|NCT01431300|P2|Participant Flow|0.02 mmol/kg of Gadofosveset|Intravenous administration of gadofosveset via power injector at onset of MRI image acquisition
239244|NCT01431300|P1|Participant Flow|0.01 mmol/kg of Gadofosveset|Intravenous administration of gadofosveset via power injector at onset of MRI image acquisition
239248|NCT01431300|O3|Outcome|0.03 mmol/kg|"FDA-approved dose for lower extremity arterial imaging~gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent"
239249|NCT01431300|O2|Outcome|0.02 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
239250|NCT01431300|O1|Outcome|0.01 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
239251|NCT01431300|E3|Reported Event|0.03 mmol/kg|"FDA-approved dose for lower extremity arterial imaging~gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent"
239252|NCT01431300|E2|Reported Event|0.02 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
239253|NCT01431300|E1|Reported Event|0.01 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
239254|NCT01431287|B6|Baseline|Total|Total of all reporting groups
239255|NCT01431287|B5|Baseline|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239256|NCT01431287|B4|Baseline|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239257|NCT01431287|B3|Baseline|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239258|NCT01431287|B2|Baseline|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239259|NCT01431287|B1|Baseline|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239260|NCT01431287|P5|Participant Flow|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239261|NCT01431287|P4|Participant Flow|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239262|NCT01431287|P3|Participant Flow|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239263|NCT01431287|P2|Participant Flow|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239264|NCT01431287|P1|Participant Flow|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239265|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239266|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239267|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239268|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239269|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239270|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239271|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239272|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239273|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239274|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239275|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239276|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239277|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239278|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239279|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239280|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239281|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239282|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239283|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239284|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239285|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239286|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239287|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239288|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239290|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239291|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239292|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239293|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239294|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239295|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239296|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239297|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239298|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239299|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239300|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239301|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239302|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239303|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239304|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239305|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239306|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239307|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239308|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239309|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239310|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239311|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239312|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239313|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239314|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239315|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239316|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239317|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239318|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239319|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239320|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239321|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239322|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239323|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239324|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239325|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239326|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239327|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239328|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239329|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239330|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239372|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239331|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239332|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239333|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239334|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239335|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239336|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239337|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239338|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239339|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239340|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239341|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239342|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239343|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239344|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239345|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239346|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239347|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239348|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239349|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239350|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239351|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239352|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239353|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239354|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239355|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239356|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239357|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239358|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239359|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239360|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239361|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239362|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239363|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239364|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239365|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239366|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239367|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239368|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239369|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239370|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239371|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
240066|NCT01429532|P2|Participant Flow|Group II|2.2-mm-incision-size phacoemulsification system
239373|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239374|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239375|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239376|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239377|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239378|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239379|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239380|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239381|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239382|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239383|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239384|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239385|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239386|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239387|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239388|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239389|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239390|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239391|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239392|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239393|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239394|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239395|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239396|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239397|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239398|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239399|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239400|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239401|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239402|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239403|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239404|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239405|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239406|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239407|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239408|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239409|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239410|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239411|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
239412|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239413|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
239414|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
239415|NCT01431287|E5|Reported Event|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239416|NCT01431287|E4|Reported Event|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239417|NCT01431287|E3|Reported Event|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239418|NCT01431287|E2|Reported Event|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239419|NCT01431287|E1|Reported Event|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239420|NCT01431274|B6|Baseline|Total|Total of all reporting groups
239421|NCT01431274|B5|Baseline|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239422|NCT01431274|B4|Baseline|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239423|NCT01431274|B3|Baseline|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239424|NCT01431274|B2|Baseline|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239425|NCT01431274|B1|Baseline|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239426|NCT01431274|P5|Participant Flow|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239427|NCT01431274|P4|Participant Flow|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239428|NCT01431274|P3|Participant Flow|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239429|NCT01431274|P2|Participant Flow|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239430|NCT01431274|P1|Participant Flow|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239431|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239432|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239433|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239434|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239435|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239436|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239437|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239438|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239439|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239440|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239441|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239442|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239443|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239444|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239445|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239446|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239447|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239764|NCT01430624|B3|Baseline|Standard Care (Completing Baseline)|Standard Care Condition completing baseline
239448|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239449|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239450|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239451|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239452|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239453|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239454|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239455|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239456|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239457|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239458|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239459|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239460|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239461|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239462|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239463|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239464|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239465|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239466|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239467|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239468|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239469|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239470|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239471|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239472|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239473|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239474|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239475|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239476|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239477|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239478|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239479|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239480|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239481|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239482|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239483|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239484|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239485|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239486|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239487|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239488|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239489|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239490|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239491|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239492|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239493|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239494|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239495|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239496|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239497|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239498|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239499|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239500|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239501|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239502|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239503|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239504|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239505|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239506|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239507|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239508|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239509|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239510|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239511|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239512|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239513|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239514|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239515|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239516|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239517|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239518|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239519|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239520|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239521|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239522|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239523|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239524|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239525|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239526|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239527|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239528|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239529|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239530|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239531|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239532|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239533|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239534|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239535|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239536|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239537|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239538|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239539|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239540|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239541|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239542|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239543|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239544|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239545|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239546|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239547|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239548|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239765|NCT01430624|B2|Baseline|PIRI (Completing Baseline)|Pleasant Imagery and Relaxation Instruction
239549|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239550|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239551|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239552|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239553|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239554|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239555|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239556|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239557|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239558|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239559|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239560|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239561|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239562|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239563|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239564|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239565|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239566|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239567|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239568|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239569|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239570|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239571|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239572|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239573|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239574|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239575|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239576|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239577|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239578|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239579|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239580|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239581|NCT01431274|E5|Reported Event|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239766|NCT01430624|B1|Baseline|PPRS (Completing Baseline)|Prevention of Post-Sexual Assault Stress
239767|NCT01430624|P3|Participant Flow|Standard Care|Treatment as usual
239582|NCT01431274|E4|Reported Event|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239583|NCT01431274|E3|Reported Event|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239584|NCT01431274|E2|Reported Event|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239585|NCT01431274|E1|Reported Event|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
239586|NCT01431170|B3|Baseline|Total|Total of all reporting groups
239587|NCT01431170|B2|Baseline|Polytrim Treatment Group|Subjects received Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days.
239588|NCT01431170|B1|Baseline|Besivance Treatment Group|Subjects received Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days.
239589|NCT01431170|P2|Participant Flow|Polytrim Treatment Group|Subjects receive Polytrim ophthalmic solution one drop in the study eye three times daily for 10 days.
239590|NCT01431170|P1|Participant Flow|Besivance Treatment Group|Subjects receive Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily for 10 days.
239591|NCT01431170|O2|Outcome|Polytrim Treatment Group|Number of subjects treated with Polytrim ophthalmic solution, who achieved treatment success by the study close-out visit (week 16).
239592|NCT01431170|O1|Outcome|Besivance Treatment Group|Number of subjects treated with Besivance™ ophthalmic suspension, 0.6%, who achieved treatment success by the study close-out visit (week 16).
239593|NCT01431170|O2|Outcome|Polytrim Safety Outcomes|Number of reported medication safety issues in the Polytrim Treatment Group
239594|NCT01431170|O1|Outcome|Besivance Safety Outcomes|Number of reported medication safety issues in the Besivance Treatment Group.
239595|NCT01431170|O2|Outcome|Polytrim Treatment Group|Number of Treatment Failures for subjects randomized to the Polytrim treatment group.
239596|NCT01431170|O1|Outcome|Besivance Treatment Group|Number of Treatment Failures for subjects randomized to the Besivance treatment group.
239597|NCT01431170|O2|Outcome|Efficacy of Polytrim Treatment Group|Number of subjects who had a recurrence randomized to the Polytrim treatment group,
239598|NCT01431170|O1|Outcome|Efficacy of Besivance Treatment Group|Number of subjects who had a recurrence randomized to the Besivance treatment group.
239599|NCT01431170|O2|Outcome|Polytrim Treatment Group|Number of subjects who had a recurrence randomized to the Polytrim treatment group,
239600|NCT01431170|O1|Outcome|Besivance Treatment Group|Number of subjects who had a recurrence randomized to the Besivance treatment group.
239601|NCT01431170|O2|Outcome|Polytrim Treatment Group|Subjects received Polytrim ophthalmic solution in the study eye, one drop three times daily for ten days.
239602|NCT01431170|O1|Outcome|Besivance Treatment Group|Subjects received Besivance ophthalmic solution in the study eye, one drop three times a day for ten days
239603|NCT01431170|E2|Reported Event|Polytrim Treatment Group|Subjects randomized to the Polytrim treatment group.
239604|NCT01431170|E1|Reported Event|Besivance Treatment Group|Subjects randomized to the Besivance treatment group.
239605|NCT01431144|B3|Baseline|Total|Total of all reporting groups
239606|NCT01431144|B2|Baseline|Connective Tissue Autograft|A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
239607|NCT01431144|B1|Baseline|Connective Tissue Allograft|A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
239608|NCT01431144|P2|Participant Flow|Connective Tissue Autograft|A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
239609|NCT01431144|P1|Participant Flow|Connective Tissue Allograft|A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
239610|NCT01431144|O2|Outcome|Connective Tissue Autograft|A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
239611|NCT01431144|O1|Outcome|Connective Tissue Allograft|A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
239612|NCT01431144|E2|Reported Event|Connective Tissue Autograft|A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
239613|NCT01431144|E1|Reported Event|Connective Tissue Allograft|A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
239614|NCT01431131|B3|Baseline|Total|Total of all reporting groups
239615|NCT01431131|B2|Baseline|Intrasocket Plus Facial Overlay Graft|Intrasocket cancellous allograft plus a facial overlay bovine xenograft
239616|NCT01431131|B1|Baseline|Intrasocket Graft|Positive control, an intrasocket cancellous allograft was placed
239617|NCT01431131|P2|Participant Flow|Intrasocket Plus Facial Overlay Graft|Intrasocket cancellous allograft plus a facial overlay bovine xenograft
239618|NCT01431131|P1|Participant Flow|Intrasocket Graft|Positive control, an intrasocket cancellous allograft is placed
239619|NCT01431131|O2|Outcome|Intrasocket Plus Facial Overlay Graft|Intrasocket cancellous allograft plus a facial overlay bovine xenograft
239620|NCT01431131|O1|Outcome|Intrasocket Graft|Positive control, an intrasocket cancellous allograft was placed
239621|NCT01431131|O2|Outcome|Intrasocket Plus Facial Overlay Graft|Intrasocket cancellous allograft plus a facial overlay bovine xenograft
239622|NCT01431131|O1|Outcome|Intrasocket Graft|Positive control, an intrasocket cancellous allograft was placed
239623|NCT01431131|E2|Reported Event|Intrasocket Plus Facial Overlay Graft|Intrasocket cancellous allograft plus a facial overlay bovine xenograft
239624|NCT01431131|E1|Reported Event|Intrasocket Graft|Positive control, an intrasocket cancellous allograft will be placed
239625|NCT01431079|B3|Baseline|Total|Total of all reporting groups
239626|NCT01431079|B2|Baseline|Knowledge-based Education|"This comparison arm will provide education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
239627|NCT01431079|B1|Baseline|Health Belief Model Based Education|"This experimental arm will provide an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
239628|NCT01431079|P2|Participant Flow|Knowledge-based Education|"This comparison arm will provide education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
239629|NCT01431079|P1|Participant Flow|Health Belief Model Based Education|"This experimental arm will provide an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
239630|NCT01431079|O6|Outcome|Follow-up Knowledge-based Education|This comparison arm will provide follow-up data for education based on knowledge regarding HPV vaccine acceptability.
239631|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
239632|NCT01431079|O4|Outcome|Post Test Knowledge-based Education|This comparison arm will provide post test data for education based on knowledge regarding HPV vaccine acceptability.
239633|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide post test data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
239634|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
239635|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
239636|NCT01431079|O6|Outcome|Follow-up Knowledge Based Education|This comparison arm will provide follow-up data for education based on knowledge regarding HPV vaccine acceptability.
239637|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
239638|NCT01431079|O4|Outcome|Post Test Knowledge-based Education|This comparison arm will provide post test data for education based on knowledge regarding HPV vaccine acceptability.
239639|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide post test data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
239640|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
239641|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
239642|NCT01431079|O6|Outcome|Follow-up Knowledge-based Education|This comparison arm will provide follow-up data for education based on knowledge regarding HPV vaccine acceptability.
239643|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
239644|NCT01431079|O4|Outcome|Post Test Knowledge-based Education|This comparison arm will provide post test data for education based on knowledge regarding HPV vaccine acceptability.
239645|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide post test data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
239646|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
239647|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
239648|NCT01431079|O6|Outcome|Follow-up Knowledge Based Education|This comparison arm will provide follow-up data for an education based on knowledge regarding HPV vaccine acceptability.
239649|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
239650|NCT01431079|O4|Outcome|Post Test Knowledge-based Education|This comparison arm will provide post test data for an education based on knowledge regarding HPV vaccine acceptability.
239651|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide posttest data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
240067|NCT01429532|P1|Participant Flow|Group I|1.8-mm-incision-size phacoemulsification system
239652|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for an education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
239653|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
239654|NCT01431079|O6|Outcome|Follow-up Knowledge Based Education|This comparison arm will provide follow-up data for education based on knowledge regarding HPV vaccine acceptability.
239655|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
239656|NCT01431079|O4|Outcome|Post Test Knowledge Based Education|This comparison arm will provide post test data for education based on knowledge regarding HPV vaccine acceptability.
239657|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide post test data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
239658|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
239659|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide base line data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
239660|NCT01431079|O6|Outcome|Follow-up Knowledge Based Education|This control group will provide follow-up data for knowledge based education for HPV vaccine
239661|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental group will provide follow-up data for an Health belief model based educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
239662|NCT01431079|O4|Outcome|Post Test Knowledge Based Education|This control group will provide post test data for knowledge based education for HPV vaccine
239663|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental group will provide post test data for an HBM based educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
239664|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
239665|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
239666|NCT01431079|O6|Outcome|Follow-up Knowledge Based Education|This comparison arm will provide follow-up data regarding education based on knowledge regarding HPV vaccine acceptability.
239667|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
239668|NCT01431079|O4|Outcome|Post Test Knowledge Based Education|This comparison arm will provide post test data regarding education based on knowledge regarding HPV vaccine acceptability.
239669|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide post test data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
239670|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data regarding education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
239671|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
239672|NCT01431079|O6|Outcome|Follow-up Knowledge-based Education|This comparison arm will provide follow-up data for number of people who have taken the HPV vaccine after an education based on knowledge regarding HPV vaccine acceptability.
239673|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for number of people who have taken HPV vaccine upto 3 months after an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
239674|NCT01431079|O4|Outcome|Post Test Knowledge-based Education|This comparison arm will provide post test data for number of people who have taken the HPV vaccine after an education based on knowledge regarding HPV vaccine acceptability.
239675|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide post test data for number of people who have taken HPV vaccine after an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
239676|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for number of people who have taken the HPV vaccine before an education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
240068|NCT01429532|O3|Outcome|Group III|3.0-mm-incision-size phacoemulsification system
239677|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for number of people who have taken HPV vaccine before an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
239678|NCT01431079|E2|Reported Event|Knowledge-based Education|"This comparison arm will provide education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
239679|NCT01431079|E1|Reported Event|Health Belief Model Based Education|"This experimental arm will provide an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
239680|NCT01431014|B3|Baseline|Total|Total of all reporting groups
239681|NCT01431014|B2|Baseline|"DexamethasoneLow-dose"|"5mg~Dexamethasonelow-dose : 5mg"
239682|NCT01431014|B1|Baseline|"DexamethasoneHigh-dose"|"15mg~Dexamethasonehigh-dose : 15 mg"
239683|NCT01431014|P2|Participant Flow|"DexamethasoneLow-dose"|"5mg~Dexamethasonelow-dose : 5mg"
239684|NCT01431014|P1|Participant Flow|"DexamethasoneHigh-dose"|"15mg~Dexamethasonehigh-dose : 15 mg"
239685|NCT01431014|O2|Outcome|"DexamethasoneLow-dose"|"5mg Dexamethasonelow-dose : 5 mg"
239686|NCT01431014|O1|Outcome|"DexamethasoneHigh-dose"|"15mg Dexamethasonehigh-dose : 15 mg"
239687|NCT01431014|E2|Reported Event|"DexamethasoneHigh-dose"|"15mg~Dexamethasonehigh-dose: 15 mg"
239688|NCT01431014|E1|Reported Event|"DexamethasoneLow-dose"|"5mg~Dexamethasonelow-dose: 5mg"
239689|NCT01430819|B3|Baseline|Total|Total of all reporting groups
239690|NCT01430819|B2|Baseline|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
239691|NCT01430819|B1|Baseline|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
239692|NCT01430819|P2|Participant Flow|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine, Fluzone® High-Dose 2011-2012 Formulation.
239693|NCT01430819|P1|Participant Flow|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation
239694|NCT01430819|O2|Outcome|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
239695|NCT01430819|O1|Outcome|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
239696|NCT01430819|O2|Outcome|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
239697|NCT01430819|O1|Outcome|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
239698|NCT01430819|O2|Outcome|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
239699|NCT01430819|O1|Outcome|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
239700|NCT01430819|O2|Outcome|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
239701|NCT01430819|O1|Outcome|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
239702|NCT01430819|E2|Reported Event|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
239703|NCT01430819|E1|Reported Event|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
239704|NCT01430754|B4|Baseline|Total|Total of all reporting groups
239705|NCT01430754|B3|Baseline|Placebo (Randomized)|"Placebo capsules~Placebo: Placebo capsules, daily"
239706|NCT01430754|B2|Baseline|Tasimelteon (Randomized)|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
239707|NCT01430754|B1|Baseline|Run-In - Not Randomized|"20 mg tasimelteon capsules~tasimelteon: 20 mg capsules, daily"
239708|NCT01430754|P2|Participant Flow|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
239709|NCT01430754|P1|Participant Flow|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
239710|NCT01430754|O2|Outcome|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
239711|NCT01430754|O1|Outcome|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
239712|NCT01430754|O2|Outcome|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
239713|NCT01430754|O1|Outcome|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
239714|NCT01430754|O2|Outcome|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
239715|NCT01430754|O1|Outcome|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
239716|NCT01430754|O2|Outcome|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
239717|NCT01430754|O1|Outcome|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
239718|NCT01430754|O2|Outcome|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
239719|NCT01430754|O1|Outcome|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
239720|NCT01430754|O2|Outcome|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
239721|NCT01430754|O1|Outcome|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
239722|NCT01430754|E4|Reported Event|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
239723|NCT01430754|E3|Reported Event|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
239724|NCT01430754|E2|Reported Event|Run-In - Not Randomized|"20 mg tasimelteon capsules~tasimelteon: 20 mg capsules, daily"
239725|NCT01430754|E1|Reported Event|Total Run-In|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
239726|NCT01430741|B5|Baseline|Total|Total of all reporting groups
240069|NCT01429532|O2|Outcome|Group II|2.2-mm-incision-size phacoemulsification system
239727|NCT01430741|B4|Baseline|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans
239728|NCT01430741|B3|Baseline|Enhanced Implementation Approach GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
239729|NCT01430741|B2|Baseline|MISSION-Vet - IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans."
239730|NCT01430741|B1|Baseline|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
239731|NCT01430741|P4|Participant Flow|GTO MISSION Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans.
239732|NCT01430741|P3|Participant Flow|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
239733|NCT01430741|P2|Participant Flow|MISSION-Vet IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
239734|NCT01430741|P1|Participant Flow|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
239735|NCT01430741|O4|Outcome|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans.
239736|NCT01430741|O3|Outcome|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
239737|NCT01430741|O2|Outcome|MISSION-Vet IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
239738|NCT01430741|O1|Outcome|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
239739|NCT01430741|O4|Outcome|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans.
239740|NCT01430741|O3|Outcome|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
239741|NCT01430741|O2|Outcome|MISSION-Vet IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
239742|NCT01430741|O1|Outcome|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
239743|NCT01430741|O4|Outcome|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans.
239744|NCT01430741|O3|Outcome|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
239768|NCT01430624|P2|Participant Flow|PIRI Video|"Pleasant imagery and relaxation instruction~PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
240004|NCT01430091|O2|Outcome|ODT on Top of Tongue|5-mg prasugrel orally disintegrating tablet (ODT) placed on the tongue and allowed to disintegrate, no liquid given.
239745|NCT01430741|O2|Outcome|MISSION-Vet IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
239746|NCT01430741|O1|Outcome|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
239747|NCT01430741|O4|Outcome|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans.
239748|NCT01430741|O3|Outcome|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
239749|NCT01430741|O2|Outcome|MISSION-Vet IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
239750|NCT01430741|O1|Outcome|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
239751|NCT01430741|O4|Outcome|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans.
239752|NCT01430741|O3|Outcome|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
239753|NCT01430741|O2|Outcome|MISSION-Vet IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
239754|NCT01430741|O1|Outcome|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
239755|NCT01430741|O4|Outcome|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans.
239756|NCT01430741|O3|Outcome|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
239757|NCT01430741|O2|Outcome|MISSION-Vet IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
239758|NCT01430741|O1|Outcome|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
239759|NCT01430741|E4|Reported Event|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans
239760|NCT01430741|E3|Reported Event|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
239761|NCT01430741|E2|Reported Event|MISSION-Vet - IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
239762|NCT01430741|E1|Reported Event|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
239763|NCT01430624|B4|Baseline|Total|Total of all reporting groups
239769|NCT01430624|P1|Participant Flow|PPRS Video|"Prevention of post sexual assault stress~PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
239770|NCT01430624|O3|Outcome|Standard Care|Treatment as usual which included standard care
239771|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction~PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
239772|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress~PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
239773|NCT01430624|O3|Outcome|Standard Care|Treatment as usual
239774|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction~PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
239775|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress~PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
239776|NCT01430624|O3|Outcome|Standard Care|Treatment as usual
239777|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction~PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
239778|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress~PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
239779|NCT01430624|O3|Outcome|Standard Care|Treatment as usual
239780|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction~PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
239781|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress~PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
239782|NCT01430624|O3|Outcome|Standard Care|Treatment as usual
239783|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction~PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
239784|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress~PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
239785|NCT01430624|O3|Outcome|SC Condition|Standard Care Completing Follow-up
239786|NCT01430624|O2|Outcome|PIRI|Pleasant Imagery and Relaxation Condition
239787|NCT01430624|O1|Outcome|PPRS|Prevention of Post-Sexual Assault Stress
239788|NCT01430624|O3|Outcome|Standard Care|Treatment as usual
239789|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction~PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
239790|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress~PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
239791|NCT01430624|O3|Outcome|Standard Care|Treatment as usual
239792|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction~PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
239793|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress~PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
239794|NCT01430624|E3|Reported Event|Standard Care Condition|Standard Care Condition
239795|NCT01430624|E2|Reported Event|PIRI|Pleasant Imagery and Relaxation Instruction
239796|NCT01430624|E1|Reported Event|PPRS|Prevention of Post-Sexual Assault Stress
239797|NCT01430611|B3|Baseline|Total|Total of all reporting groups
239798|NCT01430611|B2|Baseline|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
239799|NCT01430611|B1|Baseline|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
239800|NCT01430611|P2|Participant Flow|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
239801|NCT01430611|P1|Participant Flow|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
239802|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
239803|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
239804|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
239805|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
239806|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
239807|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
239808|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
239809|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
240005|NCT01430091|O1|Outcome|Clinical Tablet|5-milligrams (mg) prasugrel clinical tablet swallowed whole with approximately 180 milliliters (ml) water.
239810|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
239811|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
239812|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
239813|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
239814|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
239815|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
239816|NCT01430611|E2|Reported Event|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
239817|NCT01430611|E1|Reported Event|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
239818|NCT01430585|B1|Baseline|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
239819|NCT01430585|P1|Participant Flow|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
239820|NCT01430585|O3|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
239821|NCT01430585|O2|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
239822|NCT01430585|O1|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
239823|NCT01430585|O3|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
239824|NCT01430585|O2|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
239825|NCT01430585|O1|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
239826|NCT01430585|O4|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
239827|NCT01430585|O3|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
239828|NCT01430585|O2|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
239829|NCT01430585|O1|Outcome|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
239830|NCT01430585|O4|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
239831|NCT01430585|O3|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
239832|NCT01430585|O2|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
239833|NCT01430585|O1|Outcome|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
239834|NCT01430585|O1|Outcome|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
239835|NCT01430585|O4|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
239836|NCT01430585|O3|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
239861|NCT01430455|P1|Participant Flow|Tranylcypromine|"Active, open-label tranylcypromine treatment~Tranylcypromine: Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study"
239837|NCT01430585|O2|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
239838|NCT01430585|O1|Outcome|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
239839|NCT01430585|O4|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
239840|NCT01430585|O3|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
239841|NCT01430585|O2|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
239842|NCT01430585|O1|Outcome|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
239843|NCT01430585|O3|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
239844|NCT01430585|O2|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
239845|NCT01430585|O1|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
239846|NCT01430585|O3|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
239847|NCT01430585|O2|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
239848|NCT01430585|O1|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
239849|NCT01430585|O1|Outcome|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
239850|NCT01430585|E1|Reported Event|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
239851|NCT01430468|B3|Baseline|Total|Total of all reporting groups
239852|NCT01430468|B2|Baseline|Standard Group|Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.
239853|NCT01430468|B1|Baseline|Glenoid Positioning System|"For the patients randomized to the GPS group, the surgeon will be given the GPS patient specific instrumentation and a model of the glenoid surface showing the exact placement and fit of the GPS alignment instruments.~Glenoid Positioning System: Design and fabrication of patient specific instrument for placement of a guide pin to be used to aid in bone preparation for placement of a metaglene and its fixation screws or anatomic glenoid component"
239854|NCT01430468|P2|Participant Flow|Standard Group|Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.
239855|NCT01430468|P1|Participant Flow|Glenoid Positioning System|"For the patients randomized to the GPS group, the surgeon will be given the GPS patient specific instrumentation and a model of the glenoid surface showing the exact placement and fit of the GPS alignment instruments.~Glenoid Positioning System: Design and fabrication of patient specific instrument for placement of a guide pin to be used to aid in bone preparation for placement of a metaglene and its fixation screws or anatomic glenoid component"
239856|NCT01430468|O2|Outcome|Standard Group|Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.
239857|NCT01430468|O1|Outcome|Glenoid Positioning System|"For the patients randomized to the GPS group, the surgeon will be given the GPS patient specific instrumentation and a model of the glenoid surface showing the exact placement and fit of the GPS alignment instruments.~Glenoid Positioning System: Design and fabrication of patient specific instrument for placement of a guide pin to be used to aid in bone preparation for placement of a metaglene and its fixation screws or anatomic glenoid component"
239858|NCT01430468|E2|Reported Event|Standard Group|Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.
239859|NCT01430468|E1|Reported Event|Glenoid Positioning System|"For the patients randomized to the GPS group, the surgeon will be given the GPS patient specific instrumentation and a model of the glenoid surface showing the exact placement and fit of the GPS alignment instruments.~Glenoid Positioning System: Design and fabrication of patient specific instrument for placement of a guide pin to be used to aid in bone preparation for placement of a metaglene and its fixation screws or anatomic glenoid component"
239860|NCT01430455|B1|Baseline|Tranylcypromine|"Active, open-label tranylcypromine treatment~Tranylcypromine: Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study"
239862|NCT01430455|O1|Outcome|Tranylcypromine|"Active, open-label tranylcypromine treatment~Tranylcypromine: Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study"
239863|NCT01430455|E1|Reported Event|Tranylcypromine|"Active, open-label tranylcypromine treatment~Tranylcypromine: Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study"
239864|NCT01430403|B4|Baseline|Total|Total of all reporting groups
239865|NCT01430403|B3|Baseline|Placebo|Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.
239866|NCT01430403|B2|Baseline|Inhaled Corticosteroid Boost Therapy (ICS)|Participants in the Inhaled Corticosteroid (ICS) boost arm received active ICS and placebo injections of omalizumab (Xolair(R)). Self-administered fluticasone (Flovent (R) Diskus) inhalers sufficient to deliver the required 200 mcg or 500 mcg daily boost of fluticasone were used. All participants received standardized specialist asthma care.
239867|NCT01430403|B1|Baseline|Omalizumab|Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
239868|NCT01430403|P3|Participant Flow|Placebo|Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.
239869|NCT01430403|P2|Participant Flow|Inhaled Corticosteroid Boost Therapy (ICS)|Participants in the Inhaled Corticosteroid (ICS) boost arm received active ICS and placebo injections of omalizumab (Xolair(R)). Self-administered fluticasone (Flovent (R) Diskus) inhalers sufficient to deliver the required 200 mcg or 500 mcg daily boost of fluticasone were used. All participants received standardized specialist asthma care.
239870|NCT01430403|P1|Participant Flow|Omalizumab|Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
239871|NCT01430403|O2|Outcome|Placebo|Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.
239872|NCT01430403|O1|Outcome|Omalizumab|Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
239873|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239874|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239875|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239876|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239877|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239878|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239879|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239880|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239881|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239940|NCT01430325|E3|Reported Event|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
239882|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239883|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239884|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239885|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239886|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239887|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239888|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239889|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239890|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239891|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239892|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239893|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239894|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239895|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239896|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239897|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239941|NCT01430325|E2|Reported Event|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
239898|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239899|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239900|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239901|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239902|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239903|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239904|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239905|NCT01430403|O2|Outcome|Placebo|Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.
239906|NCT01430403|O1|Outcome|Omalizumab|Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
239907|NCT01430403|O2|Outcome|Placebo|Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.
239908|NCT01430403|O1|Outcome|Omalizumab|Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
239909|NCT01430403|O2|Outcome|Samples Without Exacerbations|These nasal mucus samples were not associated with an exacerbation (defined as a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at >/= 20mg per day for 3 of any 5 consecutive days; or dexamethasone at >/= 10mg per day for >/= 1 day)
239910|NCT01430403|O1|Outcome|Samples With Exacerbations|These nasal mucus samples were associated with an exacerbation (defined as a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at >/= 20mg per day for 3 of any 5 consecutive days; or dexamethasone at >/= 10mg per day for >/= 1 day)
239911|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239912|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239913|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239942|NCT01430325|E1|Reported Event|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
239943|NCT01430299|B3|Baseline|Total|Total of all reporting groups
239914|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
239915|NCT01430403|E3|Reported Event|Placebo|Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.
239916|NCT01430403|E2|Reported Event|Inhaled Corticosteroid Boost Therapy (ICS)|Participants in the Inhaled Corticosteroid (ICS) boost arm received active ICS and placebo injections of omalizumab (Xolair(R)). Self-administered fluticasone (Flovent (R) Diskus) inhalers sufficient to deliver the required 200 mcg or 500 mcg daily boost of fluticasone were used. All participants received standardized specialist asthma care.
239917|NCT01430403|E1|Reported Event|Omalizumab|Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
239918|NCT01430325|B5|Baseline|Total|Total of all reporting groups
239919|NCT01430325|B4|Baseline|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
239920|NCT01430325|B3|Baseline|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
239921|NCT01430325|B2|Baseline|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
239922|NCT01430325|B1|Baseline|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
239923|NCT01430325|P4|Participant Flow|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
239924|NCT01430325|P3|Participant Flow|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
239925|NCT01430325|P2|Participant Flow|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
239926|NCT01430325|P1|Participant Flow|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
239927|NCT01430325|O4|Outcome|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
239928|NCT01430325|O3|Outcome|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
239929|NCT01430325|O2|Outcome|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
239930|NCT01430325|O1|Outcome|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
239931|NCT01430325|O4|Outcome|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
239932|NCT01430325|O3|Outcome|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
239933|NCT01430325|O2|Outcome|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
239934|NCT01430325|O1|Outcome|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
239935|NCT01430325|O4|Outcome|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
239936|NCT01430325|O3|Outcome|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
239937|NCT01430325|O2|Outcome|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
239938|NCT01430325|O1|Outcome|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
239939|NCT01430325|E4|Reported Event|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
239944|NCT01430299|B2|Baseline|rhBMP-2|Retrospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with rhBMP-2 in the posterolateral space.
239945|NCT01430299|B1|Baseline|OsteoSurg 300|Prospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with OsteoSurge 300 in the posterolateral space.
239946|NCT01430299|P2|Participant Flow|rhBMP-2|Retrospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with rhBMP-2 in the posterolateral space.
239947|NCT01430299|P1|Participant Flow|OsteoSurg 300|Prospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with OsteoSurge 300 in the posterolateral space.
239948|NCT01430299|O2|Outcome|rhBMP-2|Retrospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with rhBMP-2 in the posterolateral space.
239949|NCT01430299|O1|Outcome|OsteoSurg 300|Prospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with OsteoSurge 300 in the posterolateral space.
239950|NCT01430299|E2|Reported Event|rhBMP-2|Retrospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with rhBMP-2 in the posterolateral space.
239951|NCT01430299|E1|Reported Event|OsteoSurg 300|Prospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with OsteoSurge 300 in the posterolateral space.
239952|NCT01430182|B3|Baseline|Total|Total of all reporting groups
239953|NCT01430182|B2|Baseline|Morphine 0.2 mg/kg|"0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Morphine: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
239954|NCT01430182|B1|Baseline|Methadone 0.2 mg/kg|"0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Methadone: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
239955|NCT01430182|P2|Participant Flow|Morphine 0.2 mg/kg|"0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Morphine: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
239956|NCT01430182|P1|Participant Flow|Methadone 0.2 mg/kg|"0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Methadone: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
239957|NCT01430182|O2|Outcome|Morphine 0.2 mg/kg|"0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Morphine: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
239958|NCT01430182|O1|Outcome|Methadone 0.2 mg/kg|"0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Methadone: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
239959|NCT01430182|E2|Reported Event|Morphine 0.2 mg/kg|"0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Morphine: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
239960|NCT01430182|E1|Reported Event|Methadone 0.2 mg/kg|"0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Methadone: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
239961|NCT01430169|B1|Baseline|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
239962|NCT01430169|P1|Participant Flow|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg (First Injection is administered on Day 1 and the second Injection is administered on Day 2)"
239963|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
239964|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
239965|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
239966|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
239967|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
239968|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
239969|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
239970|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
239971|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
239972|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
239973|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
239974|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
239975|NCT01430169|E1|Reported Event|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
239976|NCT01430130|B1|Baseline|All Study Participants|Half of the revised incision was treated with the embrace device. Half of the revised incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
239977|NCT01430130|P1|Participant Flow|All Study Participants|Half of the revised incision was treated with the embrace device. Half of the revised incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
239978|NCT01430130|O2|Outcome|Control Side|Half of the revised incision was treated according to the investigator’s standard of care. Participant served as his own control.
239979|NCT01430130|O1|Outcome|Treated Side|Half of the revised incision was treated with the embrace device.
239980|NCT01430130|E2|Reported Event|Control Side|Half of the revised incision was treated according to the investigator’s standard of care. Participant served as his own control.
239981|NCT01430130|E1|Reported Event|Treated Side|Half of the revised incision was treated with the embrace device.
239982|NCT01430104|B1|Baseline|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the planned Teriparatide dose during the 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
239983|NCT01430104|P1|Participant Flow|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the planned Teriparatide dose during the 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
239984|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period and after the planned Teriparatide dose during the 7-day Follow-up Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
239985|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period and after the planned Teriparatide dose during the 7-day Follow-up Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
239986|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
239987|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
239988|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
239989|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide planned dose during 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
239990|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the planned Teriparatide dose during the 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
239991|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
239992|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
239993|NCT01430104|E1|Reported Event|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period and the 7-day Follow-up Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
239994|NCT01430091|B1|Baseline|Participants|Total Number of Study Participants
239995|NCT01430091|P1|Participant Flow|Participants|Received 5 milligrams (mg) prasugrel as either the clinical tablet or as an orally disintegrating tablet (ODT).
239996|NCT01430091|O5|Outcome|ODT Placed Under the Tongue|5-mg prasugrel ODT placed under the tongue and allowed to disintegrate, no liquid given.
239997|NCT01430091|O4|Outcome|ODT Chewed and Swallowed|5-mg prasugrel ODT chewed and swallowed, no liquid given.
239998|NCT01430091|O3|Outcome|ODT on Top of Tongue With Juice Chaser|5-mg prasugrel ODT placed on the tongue and allowed to disintegrate, followed by approximately 180 milliliters (ml) apple juice chaser.
239999|NCT01430091|O2|Outcome|ODT on Top of Tongue|5-mg prasugrel orally disintegrating table (ODT) placed on the tongue and allowed to disintegrate, no liquid given.
240000|NCT01430091|O1|Outcome|Clinical Tablet|5-milligrams (mg) prasugrel clinical tablet swallowed whole approximately 180 milliliters (ml) with water.
240001|NCT01430091|O5|Outcome|ODT Placed Under the Tongue|5-mg prasugrel ODT placed under the tongue and allowed to disintegrate, no liquid given.
240002|NCT01430091|O4|Outcome|ODT Chewed and Swallowed|5-mg prasugrel ODT chewed and swallowed, no liquid given.
240003|NCT01430091|O3|Outcome|ODT on Top of Tongue With Juice Chaser|5-mg prasugrel ODT placed on the tongue and allowed to disintegrate, followed by approximately 180 milliliters (ml) apple juice chaser.
240006|NCT01430091|O5|Outcome|ODT Placed Under the Tongue|5-mg prasugrel ODT placed under the tongue and allowed to disintegrate, no liquid given.
240007|NCT01430091|O4|Outcome|ODT Chewed and Swallowed|5-mg prasugrel ODT chewed and swallowed, no liquid given.
240008|NCT01430091|O3|Outcome|ODT on Top of Tongue With Juice Chaser|5-mg prasugrel ODT placed on the tongue and allowed to disintegrate, followed by approximately 180 milliliters (ml) apple juice chaser.
240009|NCT01430091|O2|Outcome|ODT on Top of Tongue|5-mg prasugrel orally disintegrating tablet (ODT) placed on the tongue and allowed to disintegrate, no liquid given.
240010|NCT01430091|O1|Outcome|Clinical Tablet|5-milligrams (mg) prasugrel clinical tablet swallowed whole with approximately 180 milliliters (ml) water.
240011|NCT01430091|E5|Reported Event|ODT (Under Tongue)|5-mg prasugrel ODT placed under the tongue and allowed to disintegrate, no liquid given.
240012|NCT01430091|E4|Reported Event|ODT (Chew and Swallow)|5-mg prasugrel ODT chewed and swallowed, no liquid given.
240013|NCT01430091|E3|Reported Event|ODT (Juice Chaser)|5-mg prasugrel ODT placed on the tongue and allowed to disintegrate, followed by approximately 180 milliliters (ml) apple juice chaser.
240014|NCT01430091|E2|Reported Event|ODT (Top of Tongue)|5-mg prasugrel orally disintegrating tablet (ODT) placed on the tongue and allowed to disintegrate, no liquid given.
240015|NCT01430091|E1|Reported Event|Clinical Tablet|5-milligrams (mg) prasugrel clinical tablet swallowed whole with approximately 180 milliliters (ml) water.
240016|NCT01429987|B5|Baseline|Total|Total of all reporting groups
240017|NCT01429987|B4|Baseline|Placebo|Subjects received placebo orally for 12 consecutive weeks
240018|NCT01429987|B3|Baseline|Plecanatide 3.0 mg|Subjects received plecanatide 3.0 mg orally for 12 consecutive weeks
240019|NCT01429987|B2|Baseline|Plecanatide 1.0 mg|Subjects received plecanatide 1.0 mg orally for 12 consecutive weeks
240020|NCT01429987|B1|Baseline|Plecanatide 0.3 mg|Subjects received plecanatide 0.3 mg orally for 12 consecutive weeks
240021|NCT01429987|P4|Participant Flow|Placebo|Subjects received placebo orally for 12 consecutive weeks
240022|NCT01429987|P3|Participant Flow|Plecanatide 3.0 mg|Subjects received plecanatide 3.0 mg orally for 12 consecutive weeks
240023|NCT01429987|P2|Participant Flow|Plecanatide 1.0 mg|Subjects received plecanatide 1.0 mg orally for 12 consecutive weeks
240024|NCT01429987|P1|Participant Flow|Plecanatide 0.3 mg|Subjects received plecanatide 0.3 mg orally for 12 consecutive weeks
240025|NCT01429987|O4|Outcome|Placebo|Subjects received placebo for 12 consecutive weeks
240026|NCT01429987|O3|Outcome|Plecanatide 3.0 mg|Subjects received plecanatide 3.0 mg for 12 consecutive weeks
240027|NCT01429987|O2|Outcome|Plecanatide 1.0 mg|Subjects received plecanatide 1.0 mg for 12 consecutive weeks
240028|NCT01429987|O1|Outcome|Plecanatide 0.3 mg|Subjects received plecanatide 0.3 mg for 12 consecutive weeks
240029|NCT01429987|E4|Reported Event|Placebo|Subjects received placebo orally for 12 consecutive weeks
240030|NCT01429987|E3|Reported Event|Plecanatide 3.0 mg|Subjects received plecanatide 3.0 mg orally for 12 consecutive weeks
240031|NCT01429987|E2|Reported Event|Plecanatide 1.0 mg|Subjects received plecanatide 1.0 mg orally for 12 consecutive weeks
240032|NCT01429987|E1|Reported Event|Plecanatide 0.3 mg|Subjects received plecanatide 0.3 mg orally for 12 consecutive weeks
240033|NCT01429623|B3|Baseline|Total|Total of all reporting groups
240034|NCT01429623|B2|Baseline|Placebo Control|"drug product excipients~Placebo: Placebo comparator"
240035|NCT01429623|B1|Baseline|Ladostigil Hemitartrate|"10mg ladostigil base~ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule"
240036|NCT01429623|P2|Participant Flow|Placebo Control|"drug product excipients~Placebo: Placebo comparator"
240037|NCT01429623|P1|Participant Flow|Ladostigil Hemitartrate|"10mg ladostigil base~ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule"
240038|NCT01429623|O2|Outcome|Placebo Control|"drug product excipients~Placebo: Placebo comparator"
240039|NCT01429623|O1|Outcome|Ladostigil Hemitartrate|"10mg ladostigil base~ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule"
240040|NCT01429623|O2|Outcome|Placebo Control|"drug product excipients~Placebo: Placebo comparator"
240041|NCT01429623|O1|Outcome|Ladostigil Hemitartrate|"10mg ladostigil base~ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule"
240042|NCT01429623|O2|Outcome|Placebo Control|"drug product excipients~Placebo: Placebo comparator"
240043|NCT01429623|O1|Outcome|Ladostigil Hemitartrate|"10mg ladostigil base~ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule"
240044|NCT01429623|O2|Outcome|Placebo Control|"drug product excipients~Placebo: Placebo comparator"
240045|NCT01429623|O1|Outcome|Ladostigil Hemitartrate|"10mg ladostigil base~ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule"
240046|NCT01429623|E2|Reported Event|Placebo Control|"drug product excipients~Placebo: Placebo comparator"
240047|NCT01429623|E1|Reported Event|Ladostigil Hemitartrate|"10mg ladostigil base~ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule"
240048|NCT01429584|B3|Baseline|Total|Total of all reporting groups
240049|NCT01429584|B2|Baseline|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
240050|NCT01429584|B1|Baseline|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
240051|NCT01429584|P2|Participant Flow|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
240052|NCT01429584|P1|Participant Flow|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
240053|NCT01429584|O2|Outcome|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
240054|NCT01429584|O1|Outcome|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
240055|NCT01429584|O2|Outcome|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
240056|NCT01429584|O1|Outcome|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
240057|NCT01429584|O2|Outcome|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
240058|NCT01429584|O1|Outcome|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
240059|NCT01429584|E2|Reported Event|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
240070|NCT01429532|O1|Outcome|Group I|1.8-mm-incision-size phacoemulsification system
240071|NCT01429532|O3|Outcome|Group III|3.0-mm-incision-size phacoemulsification system
240072|NCT01429532|O2|Outcome|Group II|2.2-mm-incision-size phacoemulsification system
240073|NCT01429532|O1|Outcome|Group I|1.8-mm-incision-size phacoemulsification system
240074|NCT01429532|O3|Outcome|Group III|3.0-mm-incision-size phacoemulsification system
240075|NCT01429532|O2|Outcome|Group II|2.2-mm-incision-size phacoemulsification system
240076|NCT01429532|O1|Outcome|Group I|1.8-mm-incision-size phacoemulsification system
240077|NCT01429532|E3|Reported Event|Group III|3.0-mm-incision-size phacoemulsification system
240078|NCT01429532|E2|Reported Event|Group II|2.2-mm-incision-size phacoemulsification system
240079|NCT01429532|E1|Reported Event|Group I|1.8-mm-incision-size phacoemulsification system
240080|NCT01429441|B3|Baseline|Total|Total of all reporting groups
240081|NCT01429441|B2|Baseline|Sham|Subjects in the sham group received a single sham injection
240082|NCT01429441|B1|Baseline|Ocriplasmin|Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
240083|NCT01429441|P2|Participant Flow|Sham|Subjects in the sham group received a single sham injection
240084|NCT01429441|P1|Participant Flow|Ocriplasmin|Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
240085|NCT01429441|O2|Outcome|Sham|Subjects in the sham group received a single sham injection
240086|NCT01429441|O1|Outcome|Ocriplasmin|Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
240087|NCT01429441|O2|Outcome|Sham|Subjects in the sham group received a single sham injection
240088|NCT01429441|O1|Outcome|Ocriplasmin|Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
240089|NCT01429441|E2|Reported Event|Sham|Subjects in the sham group received a single sham injection
240090|NCT01429441|E1|Reported Event|Ocriplasmin|Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
240091|NCT01429298|B3|Baseline|Total|Total of all reporting groups
240092|NCT01429298|B2|Baseline|Usual Care|"The attending physician administers whatever IV opioid he/she deems appropriate in whatever dose he/she chooses for initial dosing~Usual care: Attending administers IV opioid of his choosing"
240093|NCT01429298|B1|Baseline|Hydromorphone|"2 mg of IV dilaudid will be administered over 2-3 minutes as initial dose.~2 mg IV hydromorphone: 2 mg IV hydromorphone over to 2-3 minutes"
240094|NCT01429298|P2|Participant Flow|Usual Care|"The attending physician administers whatever IV opioid he/she deems appropriate in whatever dose he/she chooses for initial dosing~Usual care: Attending administers IV opioid of his choosing"
240095|NCT01429298|P1|Participant Flow|Hydromorphone|"2 mg of IV dilaudid will be administered over 2-3 minutes as initial dose.~2 mg IV hydromorphone: 2 mg IV hydromorphone over to 2-3 minutes"
240096|NCT01429298|O2|Outcome|Usual Care|"The attending physician administers whatever IV opioid he/she deems appropriate in whatever dose he/she chooses for initial dosing~Usual care: Attending administers IV opioid of his choosing"
240097|NCT01429298|O1|Outcome|Hydromorphone|"2 mg of IV dilaudid will be administered over 2-3 minutes as initial dose.~2 mg IV hydromorphone: 2 mg IV hydromorphone over to 2-3 minutes"
240098|NCT01429298|O2|Outcome|Usual Care|"The attending physician administers whatever IV opioid he/she deems appropriate in whatever dose he/she chooses for initial dosing~Usual care: Attending administers IV opioid of his choosing"
240099|NCT01429298|O1|Outcome|Hydromorphone|"2 mg of IV dilaudid will be administered over 2-3 minutes as initial dose.~2 mg IV hydromorphone: 2 mg IV hydromorphone over to 2-3 minutes"
240100|NCT01429298|O2|Outcome|Usual Care|"The attending physician administers whatever IV opioid he/she deems appropriate in whatever dose he/she chooses for initial dosing~Usual care: Attending administers IV opioid of his choosing"
240101|NCT01429298|O1|Outcome|Hydromorphone|"2 mg of IV dilaudid will be administered over 2-3 minutes as initial dose.~2 mg IV hydromorphone: 2 mg IV hydromorphone over to 2-3 minutes"
240102|NCT01429298|O2|Outcome|Usual Care|"The attending physician administers whatever IV opioid he/she deems appropriate in whatever dose he/she chooses for initial dosing~Usual care: Attending administers IV opioid of his choosing"
240103|NCT01429298|O1|Outcome|Hydromorphone|"2 mg of IV dilaudid will be administered over 2-3 minutes as initial dose.~2 mg IV hydromorphone: 2 mg IV hydromorphone over to 2-3 minutes"
240104|NCT01429298|O2|Outcome|Usual Care|"The attending physician administers whatever IV opioid he/she deems appropriate in whatever dose he/she chooses for initial dosing~Usual care: Attending administers IV opioid of his choosing"
240105|NCT01429298|O1|Outcome|Hydromorphone|"2 mg of IV dilaudid will be administered over 2-3 minutes as initial dose.~2 mg IV hydromorphone: 2 mg IV hydromorphone over to 2-3 minutes"
240106|NCT01429298|E2|Reported Event|Usual Care|"The attending physician administers whatever IV opioid he/she deems appropriate in whatever dose he/she chooses for initial dosing~Usual care: Attending administers IV opioid of his choosing"
240107|NCT01429298|E1|Reported Event|Hydromorphone|"2 mg of IV dilaudid will be administered over 2-3 minutes as initial dose.~2 mg IV hydromorphone: 2 mg IV hydromorphone over to 2-3 minutes"
240108|NCT01429285|B3|Baseline|Total|Total of all reporting groups
240109|NCT01429285|B2|Baseline|Usual Care|"Usual care~Usual care: Attending administers any IV opioid in any dose he chooses"
240110|NCT01429285|B1|Baseline|Hydromorphone|"Hydromorphone protocol~Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose"
240111|NCT01429285|P2|Participant Flow|Usual Care|"Usual care~Usual care: Attending administers any IV opioid in any dose he chooses"
240112|NCT01429285|P1|Participant Flow|Hydromorphone|"Hydromorphone protocol~Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose"
240113|NCT01429285|O2|Outcome|Usual Care|"Usual care~Usual care: Attending administers any IV opioid in any dose he chooses"
240114|NCT01429285|O1|Outcome|Hydromorphone|"Hydromorphone protocol~Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose"
240115|NCT01429285|O2|Outcome|Usual Care|"Usual care~Usual care: Attending administers any IV opioid in any dose he chooses"
241074|NCT01425801|O5|Outcome|LAS100977 2.5 μg|Dry powder for inhalation administered via Genuair®
240116|NCT01429285|O1|Outcome|Hydromorphone|"Hydromorphone protocol~Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose"
240117|NCT01429285|O2|Outcome|Usual Care|"Usual care~Usual care: Attending administers any IV opioid in any dose he chooses"
240118|NCT01429285|O1|Outcome|Hydromorphone|"Hydromorphone protocol~Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose"
240119|NCT01429285|O2|Outcome|Usual Care|"Usual care~Usual care: Attending administers any IV opioid in any dose he chooses"
240120|NCT01429285|O1|Outcome|Hydromorphone|"Hydromorphone protocol~Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose"
240121|NCT01429285|O2|Outcome|Usual Care|"Usual care~Usual care: Attending administers any IV opioid in any dose he chooses"
240122|NCT01429285|O1|Outcome|Hydromorphone|"Hydromorphone protocol~Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose"
240123|NCT01429285|O2|Outcome|Usual Care|"Usual care~Usual care: Attending administers any IV opioid in any dose he chooses"
240124|NCT01429285|O1|Outcome|Hydromorphone|"Hydromorphone protocol~Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose"
240125|NCT01429285|O2|Outcome|Usual Care|"Usual care~Usual care: Attending administers any IV opioid in any dose he chooses"
240126|NCT01429285|O1|Outcome|Hydromorphone|"Hydromorphone protocol~Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose"
240127|NCT01429285|E2|Reported Event|Usual Care|"Usual care~Usual care: Attending administers any IV opioid in any dose he chooses"
240128|NCT01429285|E1|Reported Event|Hydromorphone|"Hydromorphone protocol~Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose"
240129|NCT01429272|B5|Baseline|Total|Total of all reporting groups
240130|NCT01429272|B4|Baseline|Placebo + Aspirin|placebo minocycline + active aspirin
240131|NCT01429272|B3|Baseline|Placebo + Minocycline|placebo aspirin + active minocycline
240132|NCT01429272|B2|Baseline|Minocycline & Aspirin|"Minocycline 100mg PO BID for 6 weeks & Aspirin 81 mg PO BID for 6 weeks~Minocycline: 100 mg po bid for 6 weeks~Aspirin: 81 mg po bid for 6 weeks"
240133|NCT01429272|B1|Baseline|Placebo & Placebo|"Placebo for minocycline & placebo for aspirin~placebo: placebo for minocycline and/or aspirin"
240134|NCT01429272|P4|Participant Flow|Placebo + Aspirin|placebo minocycline + active aspirin
240135|NCT01429272|P3|Participant Flow|Placebo + Minocycline|placebo aspirin + active minocycline
240136|NCT01429272|P2|Participant Flow|Minocycline & Aspirin|"Minocycline 100mg PO BID for 6 weeks & Aspirin 81 mg PO BID for 6 weeks~Minocycline: 100 mg po bid for 6 weeks~Aspirin: 81 mg po bid for 6 weeks"
240137|NCT01429272|P1|Participant Flow|Placebo & Placebo|"Placebo for minocycline & placebo for aspirin~placebo: placebo for minocycline and/or aspirin"
240138|NCT01429272|O4|Outcome|Placebo + Aspirin|placebo minocycline + active aspirin
240139|NCT01429272|O3|Outcome|Placebo + Minocycline|placebo aspirin + active minocycline
240140|NCT01429272|O2|Outcome|Minocycline & Aspirin|"Minocycline 100mg PO BID for 6 weeks & Aspirin 81 mg PO BID for 6 weeks~Minocycline: 100 mg po bid for 6 weeks~Aspirin: 81 mg po bid for 6 weeks"
240141|NCT01429272|O1|Outcome|Placebo & Placebo|"Placebo for minocycline & placebo for aspirin~placebo: placebo for minocycline and/or aspirin"
240142|NCT01429272|O4|Outcome|Placebo + Aspirin|placebo minocycline + active aspirin
240143|NCT01429272|O3|Outcome|Placebo + Minocycline|placebo aspirin + active minocycline
240144|NCT01429272|O2|Outcome|Minocycline & Aspirin|"Minocycline 100mg PO BID for 6 weeks & Aspirin 81 mg PO BID for 6 weeks~Minocycline: 100 mg po bid for 6 weeks~Aspirin: 81 mg po bid for 6 weeks"
240145|NCT01429272|O1|Outcome|Placebo & Placebo|"Placebo for minocycline & placebo for aspirin~placebo: placebo for minocycline and/or aspirin"
240146|NCT01429272|E4|Reported Event|Placebo + Aspirin|placebo minocycline + active aspirin
240147|NCT01429272|E3|Reported Event|Placebo + Minocycline|placebo aspirin + active minocycline
240148|NCT01429272|E2|Reported Event|Minocycline & Aspirin|"Minocycline 100mg PO BID for 6 weeks & Aspirin 81 mg PO BID for 6 weeks~Minocycline: 100 mg po bid for 6 weeks~Aspirin: 81 mg po bid for 6 weeks"
240149|NCT01429272|E1|Reported Event|Placebo & Placebo|"Placebo for minocycline & placebo for aspirin~placebo: placebo for minocycline and/or aspirin"
240150|NCT01429259|B1|Baseline|Meropenem 3 Hour Prolonged Infusion|"All 30 participants will receive meropenem as a 3 hour infusion.~meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion."
240151|NCT01429259|P1|Participant Flow|Meropenem 3 Hour Prolonged Infusion|"All 30 participants will receive meropenem as a 3 hour infusion.~meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion."
240152|NCT01429259|O1|Outcome|Meropenem 3 Hour Prolonged Infusion|"All 30 participants will receive meropenem as a 3 hour infusion.~meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion."
240153|NCT01429259|O1|Outcome|Meropenem 3 Hour Prolonged Infusion|"All 30 participants will receive meropenem as a 3 hour infusion.~meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion."
240154|NCT01429259|E1|Reported Event|Meropenem 3 Hour Prolonged Infusion|"All 30 participants will receive meropenem as a 3 hour infusion.~meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion."
240155|NCT01429077|B3|Baseline|Total|Total of all reporting groups
240156|NCT01429077|B2|Baseline|Inactive Pill|
240157|NCT01429077|B1|Baseline|Levodopa|
240158|NCT01429077|P2|Participant Flow|Inactive Pill|The inactive pill was received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks.
240159|NCT01429077|P1|Participant Flow|Levodopa|The study drug (100 mg levodopa / 25 mg carbidopa), was received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks.
240160|NCT01429077|O2|Outcome|Inactive Pill|
240161|NCT01429077|O1|Outcome|Levodopa/Carbidopa|
240162|NCT01429077|E2|Reported Event|Inactive Pill|
240163|NCT01429077|E1|Reported Event|Levodopa|
240164|NCT01429064|B5|Baseline|Total|Total of all reporting groups
241075|NCT01425801|O4|Outcome|LAS100977 1.25 μg|Dry powder for inhalation administered via Genuair®
240165|NCT01429064|B4|Baseline|Patients From Arades 3104001 Dose Expansion (1400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
240166|NCT01429064|B3|Baseline|Patients From Arades 3104001 Dose Expansion (400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
240167|NCT01429064|B2|Baseline|Patients From Arades 3104001 Dose Expansion (200mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
240168|NCT01429064|B1|Baseline|Patients From Arades 3104001 Dose Escalation|200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
240169|NCT01429064|P4|Participant Flow|Patients From Arades 3104001 Dose Expansion (1400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
240170|NCT01429064|P3|Participant Flow|Patients From Arades 3104001 Dose Expansion (400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
240171|NCT01429064|P2|Participant Flow|Patients From Arades 3104001 Dose Expansion (200mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
240172|NCT01429064|P1|Participant Flow|Patients From Arades 3104001 Dose Escalation|200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
240173|NCT01429064|O4|Outcome|Patients From Arades 3104001 Dose Expansion (1400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
240174|NCT01429064|O3|Outcome|Patients From Arades 3104001 Dose Expansion (400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
240175|NCT01429064|O2|Outcome|Patients From Arades 3104001 Dose Expansion (200mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
240176|NCT01429064|O1|Outcome|Patients From Arades 3104001 Dose Escalation|200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
240177|NCT01429064|E4|Reported Event|Patients From Arades 3104001 Dose Expansion (1400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
240178|NCT01429064|E3|Reported Event|Patients From Arades 3104001 Dose Expansion (400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
240179|NCT01429064|E2|Reported Event|Patients From Arades 3104001 Dose Expansion (200mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
240180|NCT01429064|E1|Reported Event|Patients From Arades 3104001 Dose Escalation|200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
240181|NCT01429051|B1|Baseline|Intranasal Fentanyl Spray (INFS)|All participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase (I). Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence. Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.
240182|NCT01429051|P1|Participant Flow|Intranasal Fentanyl Spray (INFS)|All participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase (I). Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence. Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.
240183|NCT01429051|O3|Outcome|Tolerability Phase|Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.
240184|NCT01429051|O2|Outcome|Efficacy Phase|Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence.
240185|NCT01429051|O1|Outcome|Titration Phase|All participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase.
240186|NCT01429051|O2|Outcome|Placebo|In the Efficacy Phase Participants received placebo intranasal spray for 2 episodes of breakthrough pain.
240187|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|In the Efficacy phase participants received 400 μg INFS for 6 episodes of breakthrough pain.
240188|NCT01429051|O2|Outcome|Placebo|In the Efficacy Phase Participants received placebo intranasal spray for 2 episodes of breakthrough pain.
240189|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|In the Efficacy phase participants received 400 μg INFS for 6 episodes of breakthrough pain.
240190|NCT01429051|O2|Outcome|Placebo|In the Efficacy Phase Participants received placebo intranasal spray for 2 episodes of breakthrough pain.
240191|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|In the Efficacy phase participants received 400 μg INFS for 6 episodes of breakthrough pain.
240192|NCT01429051|O2|Outcome|Placebo|In the Efficacy Phase Participants received placebo intranasal spray for 2 episodes of breakthrough pain.
240193|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|In the Efficacy phase participants received 400 μg INFS for 6 episodes of breakthrough pain.
240194|NCT01429051|O2|Outcome|Placebo|In the Efficacy Phase Participants received placebo intranasal spray for 2 episodes of breakthrough pain.
240195|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|In the Efficacy phase participants received 400 μg INFS for 6 episodes of breakthrough pain.
240303|NCT01428258|E1|Reported Event|GMP Diet/GMP Medical Foods|All subjects received the Glycomacropeptide (GMP) diet either in the first or second period. The intervention consists of a low-Phe diet in combination with medical foods made from glycomacropeptide, a low-Phe whey protein.
241076|NCT01425801|O3|Outcome|LAS100977 0.625 μg|Dry powder for inhalation administered via Genuair®
240196|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|All participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase (I). Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence. Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.
240197|NCT01429051|O2|Outcome|Placebo|In the Efficacy Phase Participants received placebo intranasal spray for 2 episodes of breakthrough pain.
240198|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|In the Efficacy phase participants received 400 μg INFS for 6 episodes of breakthrough pain.
240199|NCT01429051|E3|Reported Event|Tolerability Phase|Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.
240200|NCT01429051|E2|Reported Event|Efficacy Phase|Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence.
240201|NCT01429051|E1|Reported Event|Titration Phase|Participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase (I).
240202|NCT01428882|B3|Baseline|Total|Total of all reporting groups
240203|NCT01428882|B2|Baseline|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion~Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
240204|NCT01428882|B1|Baseline|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion~Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
240205|NCT01428882|P2|Participant Flow|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion~Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
240206|NCT01428882|P1|Participant Flow|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion~Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
240207|NCT01428882|O2|Outcome|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion~Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
240208|NCT01428882|O1|Outcome|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion~Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
240209|NCT01428882|O2|Outcome|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion~Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
240210|NCT01428882|O1|Outcome|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion~Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
240211|NCT01428882|O2|Outcome|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion~Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
240212|NCT01428882|O1|Outcome|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion~Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
240213|NCT01428882|O2|Outcome|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion~Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
240214|NCT01428882|O1|Outcome|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion~Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
240215|NCT01428882|E2|Reported Event|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion~Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
240216|NCT01428882|E1|Reported Event|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion~Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
240217|NCT01428765|B1|Baseline|All Patients|
240218|NCT01428765|P1|Participant Flow|All Patients|
240219|NCT01428765|O1|Outcome|All Patients|
240220|NCT01428765|O1|Outcome|All Patients|
240221|NCT01428765|O1|Outcome|All Patients|
240222|NCT01428765|O1|Outcome|All Patients|
240223|NCT01428765|O1|Outcome|All Patients|
240224|NCT01428765|O1|Outcome|All Patients|
240225|NCT01428765|O1|Outcome|All Patients|
240226|NCT01428765|O1|Outcome|All Patients|
240227|NCT01428765|E1|Reported Event|All Patients|
240322|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
240323|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
240228|NCT01428713|B1|Baseline|All Study Participants|"Group A: TA first, then COCP:~Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents <18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles.~Subsequently, patients who initially received TA, received COCP.~Group B: COCP first, then TA:~Patients received COCP first. COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles. Each medication was prescribed for 3 menstrual cycles with a 1 month wash out in-between TA and COCP.~Subsequently, patients who initially received COCP, received TA."
240229|NCT01428713|P2|Participant Flow|Group B: COCP First, Then TA|"Patients received COCP first. COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles. Each medication was prescribed for 3 menstrual cycles with a 1 month wash out in-between COCP and TA.~Subsequently, patients who initially received COCP, received TA. Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents <18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles."
240230|NCT01428713|P1|Participant Flow|Group A: TA First, Then COCP|"Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents <18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles.~Subsequently, patients who initially received TA, received COCP. COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles. Each medication was prescribed for 3 menstrual cycles with a 1 month wash out in-between TA and COCP."
240231|NCT01428713|O2|Outcome|Group: COCP|Patients received COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles.
240232|NCT01428713|O1|Outcome|Group: TA|Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents <18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles.
240233|NCT01428713|E2|Reported Event|Combined Oral Contraceptives (COCP)|COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles. Each medication was prescribed for 3 menstrual cycles with a 1 month wash out in-between medications.
240234|NCT01428713|E1|Reported Event|Tranexamic Acid (TA)|"Patients received oral tranexamic acid at 1300 mg three times each day on days 1 to 5 of menstrual cycle for 3 cycles. The mean age of the study population was 14.2 years. Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents <18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles.~Subsequently, patients who initially received TA, received COCP and patients who initially received COCP, then received TA."
240235|NCT01428661|B4|Baseline|Total|Total of all reporting groups
240236|NCT01428661|B3|Baseline|Open Label Tasimelteon|20 mg capsules, PO daily for 52 weeks
240237|NCT01428661|B2|Baseline|Placebo|Placebo capsules, PO daily for 8 weeks
240238|NCT01428661|B1|Baseline|Tasimelteon|20 mg tasimelteon capsules, PO daily for 8 weeks
240239|NCT01428661|P3|Participant Flow|Open Label Tasimelteon|20 mg capsules, PO daily for 52 weeks
240240|NCT01428661|P2|Participant Flow|Placebo|Placebo capsules, PO daily for 8 weeks
240241|NCT01428661|P1|Participant Flow|Tasimelteon|20 mg tasimelteon capsules, PO daily for 8 weeks
240242|NCT01428661|O3|Outcome|Open Label Tasimelteon|20 mg capsules, PO daily for 52 weeks
240243|NCT01428661|O2|Outcome|Placebo|Placebo capsules, PO daily for 8 weeks
240244|NCT01428661|O1|Outcome|Tasimelteon|20 mg tasimelteon capsules, PO daily for 8 weeks
240245|NCT01428661|E3|Reported Event|Open Label Tasimelteon|20 mg capsules, PO daily for 52 weeks
240246|NCT01428661|E2|Reported Event|Placebo|Placebo capsules, PO daily for 8 weeks
240247|NCT01428661|E1|Reported Event|Tasimelteon|20 mg tasimelteon capsules, PO daily for 8 weeks
240248|NCT01428583|B1|Baseline|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
240249|NCT01428583|P1|Participant Flow|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
240250|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
240324|NCT01428115|O1|Outcome|Adalimumab|40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
240325|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
240251|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
240252|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
240253|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
240254|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
240255|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
240256|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
240257|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
240258|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
240259|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
240260|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
240261|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
240262|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
240326|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
240327|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
241077|NCT01425801|O2|Outcome|LAS100977 0.313 μg|Dry powder administered via the Genuair® inhaler
240263|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
240264|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
240265|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
240266|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
240267|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
240268|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
240269|NCT01428583|E1|Reported Event|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
240270|NCT01428336|B3|Baseline|Total|Total of all reporting groups
240271|NCT01428336|B2|Baseline|Volunteers|Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test
240272|NCT01428336|B1|Baseline|Patients|Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test
240273|NCT01428336|P2|Participant Flow|Volunteers|Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test
240274|NCT01428336|P1|Participant Flow|Patients|Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test
240275|NCT01428336|O2|Outcome|Volunteers|Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test
240276|NCT01428336|O1|Outcome|Patients|Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test
240277|NCT01428336|O1|Outcome|Patients + Volunteers|Every participant underwent three ACTH stimulation test and one Insulin tolerance test.
240278|NCT01428336|O1|Outcome|Patients + Volunteers|Every participant underwent three ACTH stimulation test and one Insulin tolerance test.
240279|NCT01428336|E4|Reported Event|Insulin Tolerance Test|"Subjects will undergo an Insulin Tolerance Test~Insulin tolerance test: subjects will undergo an insulin tolerance test"
240280|NCT01428336|E3|Reported Event|25 ug Cortrosyn Stimulation Test|"Subjects will undergo an ACTH stimulation test using a 25 ug cortosyn dose~25 ug Cortrosyn stimulation test: ACTH stimulation test using a 25 ug cortrosyn dose"
240281|NCT01428336|E2|Reported Event|250 ug Cortrosyn Dose Stimulation Test|"Subjects will undergo an ACTH stimulation test using 250 ug cortrosyn dose~250 ug ACTH stimulation test: ACTH stimulation test will be done using 250 ug cortrosyn dose"
240282|NCT01428336|E1|Reported Event|1ug Cortrosyn Dose Stimulation Test|"Subjects will undergo an ACTH stimulation test using a dose of 1 ug cotrosyn~ACTH stimulation test: 1 ug cortrosyn dose~1 ug cortrosyn test: Subjects will undergo an ACTH test using a 1 ug dose cortrosyn"
240283|NCT01428258|B3|Baseline|Total|Total of all reporting groups
240304|NCT01428219|B1|Baseline|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
263659|NCT01349114|E1|Reported Event|Aliskiren|aliskiren 300 mg daily
240284|NCT01428258|B2|Baseline|AA Diet - GMP Diet|"In this randomized crossover study, half of subjects will be assigned to an arm that consists of the AA diet followed by the GMP diet referred to as the Amino Acid (AA) Diet given first intervention.~Amino Acid (AA) Diet Given First: The intervention compares the usual amino acid (AA) low-phenylalanine (phe) dietary therapy with a new dietary therapy for PKU, a low-phe diet containing foods and beverages made from glycomacropeptide (GMP). PKU subjects in the AA Diet-GMP Diet Arm will follow their usual AA diet for 3 weeks followed by a 3 wk wash out period. They will then replace all of the protein equivalents provided in their diet by AA formula with foods and beverages made from GMP using Glytactin as provided by Cambrooke Foods, LLC. Each dietary treatment period will maintain constant intake of total protein and phe and last for 3 weeks in subjects living at home."
240285|NCT01428258|B1|Baseline|GMP Diet-AA Diet|"In this randomized crossover study, half of subjects will be assigned to an arm that consists of the the GMP diet followed by the AA diet referred to as the Glycomacropeptide (GMP) diet given first intervention.~Glycomacropeptide (GMP) diet given first: The intervention compares a new low-phenylalanine (phe) dietary therapy for PKU, a diet containing foods and beverages made from GMP using Glytactin provided by Cambrooke Foods LLC, with the usual amino acid (AA) low-phe dietary therapy. PKU subjects in the GMP Diet-AA Diet Arm will follow the GMP diet that will replace all of the dietary protein equivalents provided by AA formula with foods and beverages made from GMP for 3 weeks followed by a 3 wk wash out period. They will then follow the usual AA diet for 3 weeks. Each dietary treatment period will maintain constant intake of total protein and phe and last for 3 weeks in subjects living at home."
240286|NCT01428258|P2|Participant Flow|AA Diet - GMP Diet|"In this randomized crossover study, half of subjects will be assigned to an arm that consists of the AA diet followed by the GMP diet referred to as the Amino Acid (AA) Diet given first intervention.~Amino Acid (AA) Diet Given First: The intervention compares the usual amino acid (AA) low-phenylalanine (phe) dietary therapy with a new dietary therapy for PKU, a low-phe diet containing foods and beverages made from glycomacropeptide (GMP). PKU subjects in the AA Diet-GMP Diet Arm will follow their usual AA diet for 3 weeks followed by a 3 wk wash out period. They will then replace all of the protein equivalents provided in their diet by AA formula with foods and beverages made from GMP using Glytactin as provided by Cambrooke Foods, LLC. Each dietary treatment period will maintain constant intake of total protein and phe and last for 3 weeks in subjects living at home."
240287|NCT01428258|P1|Participant Flow|GMP Diet-AA Diet|"In this randomized crossover study, half of subjects will be assigned to an arm that consists of the the GMP diet followed by the AA diet referred to as the Glycomacropeptide (GMP) diet given first intervention.~Glycomacropeptide (GMP) diet given first: The intervention compares a new low-phenylalanine (phe) dietary therapy for PKU, a diet containing foods and beverages made from GMP using Glytactin provided by Cambrooke Foods LLC, with the usual amino acid (AA) low-phe dietary therapy. PKU subjects in the GMP Diet-AA Diet Arm will follow the GMP diet that will replace all of the dietary protein equivalents provided by AA formula with foods and beverages made from GMP for 3 weeks followed by a 3 wk wash out period. They will then follow the usual AA diet for 3 weeks. Each dietary treatment period will maintain constant intake of total protein and phe and last for 3 weeks in subjects living at home."
240288|NCT01428258|O2|Outcome|AA Diet/AA Medical Foods|The intervention administered as the first or second dietary treatment consists of a low-Phe diet in combination with each subjects usual AA medical foods.
240289|NCT01428258|O1|Outcome|GMP Diet/GMP Medical Foods|The intervention administered as the first or second dietary treatment consists of a low-Phe diet in combination with medical foods made with glycomacropeptide.
240290|NCT01428258|O2|Outcome|AA Diet/AA Medical Foods|The intervention followed as the first or second treatment consists of a low-Phe diet in combination with each subjects usual AA medical foods.
240291|NCT01428258|O1|Outcome|GMP Diet/GMP Medical Foods|The intervention followed as the first or second treatment consists of a low-Phe diet in combination with medical foods made with glycomacropeptide.
240292|NCT01428258|O2|Outcome|Phe Concentration in Dried Blood Spots, Tandem Mass Spec|Subjects spotted their blood on filter paper at the same time as plasma was obtained at 3 or 4 time periods, dried blood spots were obtained, and analyzed for Phe concentration using tandem mass spectrometry.
240293|NCT01428258|O1|Outcome|Phe Concentration in Plasma, Ion Exchange Chromatography|Blood was collected by venipuncture at 3 to 4 time points, plasma was isolated and the concentration of Phe was determined by ion exchange chromatography.
240294|NCT01428258|O2|Outcome|AA Diet/AA Medical Foods|All subjects received the Amino Acid (AA) Diet in either the first or second period. The intervention consists of a low-Phe diet in combination with each subject's usual AA medical formula.
240295|NCT01428258|O1|Outcome|GMP Diet/GMP Medical Foods|All subjects received the Glycomacropeptide (GMP) diet either in the first or second period. The intervention consists of a low-Phe diet in combination with medical foods made from glycomacropeptide, a low-Phe whey protein.
240296|NCT01428258|O2|Outcome|AA Diet/AA Medical Foods|The intervention followed as the first or second treatment consists of a low-Phe diet in combination with each subjects usual AA medical foods.
240297|NCT01428258|O1|Outcome|GMP Diet/GMP Medical Foods|The intervention followed as the first or second treatment consists of a low-Phe diet in combination with medical foods made from glycomacropeptide .
240298|NCT01428258|O2|Outcome|AA Diet/AA Medical Foods|All subjects received the Amino Acid (AA) Diet in either the first or second period. The intervention consists of a low-Phe diet in combination with each subject's usual AA medical formula.
240299|NCT01428258|O1|Outcome|GMP Diet|All subjects received the Glycomacropeptide (GMP) diet either in the first or second period. The intervention consists of a low-Phe diet in combination with medical foods made from glycomacropeptide, a low-Phe whey protein.
240300|NCT01428258|O2|Outcome|AA Diet/AA Medical Foods|All subjects received the Amino Acid (AA) Diet in either the first or second period. The intervention consists of a low-Phe diet in combination with each subject's usual AA medical formula.
240301|NCT01428258|O1|Outcome|GMP Diet/GMP Medical Foods|All subjects received the Glycomacropeptide (GMP) diet either in the first or second period. The intervention consists of a low-Phe diet in combination with medical foods made from glycomacropeptide, a low-Phe whey protein.
240302|NCT01428258|E2|Reported Event|AA Diet/AA Medical Foods|All subjects received the Amino Acid (AA) Diet in either the first or second period. The intervention consists of a low-Phe diet in combination with each subject's usual AA medical formula.
240423|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
240305|NCT01428219|P1|Participant Flow|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
240306|NCT01428219|O1|Outcome|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
240307|NCT01428219|O1|Outcome|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
240308|NCT01428219|O1|Outcome|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
240309|NCT01428219|O1|Outcome|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
240310|NCT01428219|O1|Outcome|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
240311|NCT01428219|O1|Outcome|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
240312|NCT01428219|O1|Outcome|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
240313|NCT01428219|O1|Outcome|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
240314|NCT01428219|E1|Reported Event|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
240315|NCT01428128|B1|Baseline|Arsenic Trioxide|Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
240316|NCT01428128|P1|Participant Flow|Arsenic Trioxide|Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
240317|NCT01428128|O1|Outcome|Complete Blood Count|Blood is drawn at 9 days to obtain a complete blood count
240318|NCT01428128|O1|Outcome|Arsenic Trioxide|Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
240319|NCT01428128|E1|Reported Event|Arsenic Trioxide|Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
240320|NCT01428115|B1|Baseline|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
240321|NCT01428115|P1|Participant Flow|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
240328|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
240329|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
240330|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
240331|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
240332|NCT01428115|E1|Reported Event|Adalimumab|40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
240333|NCT01428076|B3|Baseline|Total|Total of all reporting groups
240334|NCT01428076|B2|Baseline|Polidocanol 2%|polidocanol intravenous foam 2% concentration
240335|NCT01428076|B1|Baseline|Polidocanol 1%|polidocanol injectable foam 1% concentration
240336|NCT01428076|P2|Participant Flow|Polidocanol 2%|polidocanol injectable foam 2% concentration
240337|NCT01428076|P1|Participant Flow|Polidocanol 1%|polidocanol injectable foam 1% concentration
240338|NCT01428076|O4|Outcome|Females- Polidocanol 2%|polidocanol injectable foam 2% concentration
240339|NCT01428076|O3|Outcome|Females-polidocanol 1%|polidocanol injectable foam 1% concentration
240340|NCT01428076|O2|Outcome|Males-polidocanol 2%|polidocanol injectable foam 2% concentration
240341|NCT01428076|O1|Outcome|Males-polidocanol 1%|polidocanol injectable foam 1% concentration
240342|NCT01428076|E2|Reported Event|Polidocanol 2%|polidocanol injectable foam 2% concentration
240343|NCT01428076|E1|Reported Event|Polidocanol 1%|polidocanol injectable foam 1% concentration
240344|NCT01428063|B4|Baseline|Total|Total of all reporting groups
240345|NCT01428063|B3|Baseline|Daclatasvir + pegIFN-2a+ Ribavirin|Patients received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
240346|NCT01428063|B2|Baseline|Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin|Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
240347|NCT01428063|B1|Baseline|Daclatasvir + Asunaprevir|Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks
240348|NCT01428063|P3|Participant Flow|Daclatasvir + pegIFN-2a+ Ribavirin|Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240349|NCT01428063|P2|Participant Flow|Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin|Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
240350|NCT01428063|P1|Participant Flow|Daclatasvir + Asunaprevir|Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks
240351|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240352|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
240353|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
240354|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240355|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240356|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240357|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240358|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin|Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240359|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
263660|NCT01348854|B3|Baseline|Total|Total of all reporting groups
240360|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240361|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
240362|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
240363|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240364|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240365|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240366|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240367|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin|Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240368|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
240369|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240370|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
240371|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
240372|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240373|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240374|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240375|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240376|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin|Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240377|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
240378|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240379|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
240605|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
240380|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
240381|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240382|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240383|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240384|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240385|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin|Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240386|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
240387|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240388|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
240389|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
240390|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240391|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240392|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240393|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240394|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin|Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240395|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
240396|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240397|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
240398|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
240399|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240400|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240401|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240402|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240403|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin|Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240404|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
240405|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240406|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
240407|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
240408|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240409|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240410|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240411|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240412|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin (Genotype 4)|Genotype 4 participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240413|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
240414|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin (NR)|Participants received daclatasvir, 60-mg tablet by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly for 24 weeks + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
240415|NCT01428063|E3|Reported Event|Daclatasvir + pegIFN-2a+ Ribavirin|Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
240416|NCT01428063|E2|Reported Event|Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin|Participants received daclatasvir, 60-mg tablet by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly for 24 weeks + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
240417|NCT01428063|E1|Reported Event|Daclatasvir + Asunaprevir|Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks.
240418|NCT01427933|B3|Baseline|Total|Total of all reporting groups
240419|NCT01427933|B2|Baseline|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
240420|NCT01427933|B1|Baseline|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
240421|NCT01427933|P2|Participant Flow|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
240422|NCT01427933|P1|Participant Flow|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 milligrams/kilogram (mg/kg) administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 milligrams/square meter (mg/m²) administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
240424|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
240425|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
240426|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
240427|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
240428|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
240429|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
240430|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
240431|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
240432|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
240433|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
240434|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 milligrams/kilogram (mg/kg) administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 milligrams/square meter (mg/m²) administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
240435|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
240436|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
240437|NCT01427933|E2|Reported Event|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
240438|NCT01427933|E1|Reported Event|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
240439|NCT01427920|B3|Baseline|Total|Total of all reporting groups
240440|NCT01427920|B2|Baseline|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
240441|NCT01427920|B1|Baseline|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
240442|NCT01427920|P2|Participant Flow|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
240443|NCT01427920|P1|Participant Flow|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
240444|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
240523|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
240445|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
240446|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
240447|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
240448|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
240449|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
240450|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
240451|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
240452|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
240453|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
240489|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
240454|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
240455|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
240456|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
240457|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
240458|NCT01427920|E2|Reported Event|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
240459|NCT01427920|E1|Reported Event|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
240460|NCT01427907|B3|Baseline|Total|Total of all reporting groups
240461|NCT01427907|B2|Baseline|Sequence II: Sevelamer Then COS|Sevelamer Carbonate for 4 weeks then Calcium Acetate Oral Solution for 4 weeks
240462|NCT01427907|B1|Baseline|Sequence I: COS Then Sevelamer|Sequence I: Calcium Acetate Oral Solution for 4 weeks then Sevelamer Carbonate for 4 weeks
240463|NCT01427907|P2|Participant Flow|Sequence II: Sevelamer (4 Weeks) Then COS (4 Weeks)|Patient receive Sevelamer tablets for 4 weeks, then cross over to take COS for 4 weeks.
240464|NCT01427907|P1|Participant Flow|Sequence I: COS (4 Weeks) Then Sevelamar (4 Weeks)|Patient receive Calcium Acetate Oral Solution (COS) for 4 weeks then cross over to Sevelamer tablets for 4 weeks.
240465|NCT01427907|O2|Outcome|Sevelamer Carbonate|Sevelamer Carbonate for periods 1 and 2
240466|NCT01427907|O1|Outcome|Calcium Acetate Oral Solution|Calcium Acetate Oral Solution for periods 1 and 2
240467|NCT01427907|E2|Reported Event|Sevelamer Carbonate|Sevelamer Carbonate for periods 1 and 2
240468|NCT01427907|E1|Reported Event|Calcium Acetate Oral Solution|Sequence I: Calcium Acetate Oral Solution for periods 1 and 2
240469|NCT01427881|B1|Baseline|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
240490|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
240648|NCT01426867|B4|Baseline|Total|Total of all reporting groups
240470|NCT01427881|P1|Participant Flow|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
240471|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
240472|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
240473|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
240474|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
240475|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
240476|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
240491|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
240492|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
263763|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
240477|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
240478|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
240479|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
240480|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
240481|NCT01427881|E1|Reported Event|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
240482|NCT01427803|B3|Baseline|Total|Total of all reporting groups
240483|NCT01427803|B2|Baseline|Reasons for Misuse Interviewed Population|A subject was included in the Reasons for Misuse Interviewed Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Reasons for Misuse Cohort, misused on one or more occasions (did not comply with the label directions [took more than one tablet per dose or a subsequent dose less than 22 hours later]), and completed the reasons for misuse questions.
240484|NCT01427803|B1|Baseline|Patterns of Use User Population|A subject was included in the Patterns of Use User Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Patterns of Use Cohort, and provided e-diary data regarding their use.
240485|NCT01427803|P2|Participant Flow|Reasons for Misuse Cohort|A subject was included in the Reasons for Misuse Interviewed Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Reasons for Misuse Cohort, misused on one or more occasions (did not comply with the label directions [took more than one tablet per dose or a subsequent dose less than 22 hours later]), and completed the reasons for misuse questions.
240486|NCT01427803|P1|Participant Flow|Patterns of Use Cohort|A subject was included in the Patterns of Use User Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Patterns of Use Cohort, and provided e-diary data regarding their use.
240487|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
240488|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
240522|NCT01427738|P1|Participant Flow|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
240493|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
240494|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
240495|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
240496|NCT01427803|E1|Reported Event|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
240497|NCT01427751|B3|Baseline|Total|Total of all reporting groups
240498|NCT01427751|B2|Baseline|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
240499|NCT01427751|B1|Baseline|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
240500|NCT01427751|P2|Participant Flow|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
240501|NCT01427751|P1|Participant Flow|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
240502|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
240503|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
240504|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
240505|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
240506|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
240507|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
240508|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
240509|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
240510|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
240511|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
240512|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
240513|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
240514|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
240515|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
240516|NCT01427751|E2|Reported Event|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
240517|NCT01427751|E1|Reported Event|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
240518|NCT01427738|B3|Baseline|Total|Total of all reporting groups
240519|NCT01427738|B2|Baseline|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
240520|NCT01427738|B1|Baseline|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
240521|NCT01427738|P2|Participant Flow|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
240602|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
241134|NCT01425801|O5|Outcome|LAS100977 2.5 μg|Dry powder for inhalation administered via Genuair®
240524|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
240525|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
240526|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
240527|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
240528|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
240529|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
240530|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
240531|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
240532|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
240533|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
240534|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
240535|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
240536|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
240537|NCT01427738|E2|Reported Event|Nystatin|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
240538|NCT01427738|E1|Reported Event|Gentian Violet|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
240539|NCT01427517|B4|Baseline|Total|Total of all reporting groups
240540|NCT01427517|B3|Baseline|NAC in Controls|single intravenous administration of N-acetylcysteine in control subjects
240541|NCT01427517|B2|Baseline|NAC in GD|single intravenous administration of N-acetylcysteine in GD patients
240542|NCT01427517|B1|Baseline|NAC in PD|single intravenous administration of N-acetylcysteine in PD patients
240543|NCT01427517|P3|Participant Flow|NAC in Controls|single intravenous administration of N-acetylcysteine in control subjects
240544|NCT01427517|P2|Participant Flow|NAC in GD|single intravenous administration of N-acetylcysteine in GD patients
240545|NCT01427517|P1|Participant Flow|NAC in PD|single intravenous administration of N-acetylcysteine in PD patients
240546|NCT01427517|O3|Outcome|NAC in Controls|single intravenous administration of N-acetylcysteine in control subjects
240547|NCT01427517|O2|Outcome|NAC in GD|single intravenous administration of N-acetylcysteine in GD patients
240548|NCT01427517|O1|Outcome|NAC in PD|single intravenous administration of N-acetylcysteine in PD patients
240549|NCT01427517|E3|Reported Event|NAC in Controls|single intravenous administration of N-acetylcysteine in control subjects
240550|NCT01427517|E2|Reported Event|NAC in GD|single intravenous administration of N-acetylcysteine in GD patients
240551|NCT01427517|E1|Reported Event|NAC in PD|single intravenous administration of N-acetylcysteine in PD patients
240552|NCT01427504|B7|Baseline|Total|Total of all reporting groups
240553|NCT01427504|B6|Baseline|Sequence 3b|Sequence 3,2,1: Both boceprevir and etravirine, then etravirine only, then boceprevir only.
240554|NCT01427504|B5|Baseline|Sequence 3a|Sequence 3,1,2: both boceprevir and etravirine, then boceprevir only, then etravirine only.
240555|NCT01427504|B4|Baseline|Sequence 2b|Sequence 2,3,1: etravirine only, then both boceprevir and etravirine, then boceprevir only.
240556|NCT01427504|B3|Baseline|Sequence 2a|Sequence 2,1,3: etravirine only, then boceprevir only, then both boceprevir and etravirine.
240557|NCT01427504|B2|Baseline|Sequence 1b|Sequence 1,3,2: boceprevir only, then both boceprevir and etravirine, then etravirine only.
240558|NCT01427504|B1|Baseline|Sequence 1a|Sequence 1,2,3: boceprevir only, then etravirine only, then both boceprevir and etravirine.
240603|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
240604|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
240559|NCT01427504|P6|Participant Flow|Sequence 3b|Sequence 3,2,1: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
240560|NCT01427504|P5|Participant Flow|Sequence 3a|Sequence 3,1,2: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
240561|NCT01427504|P4|Participant Flow|Sequence 2b|Sequence 2,3,1: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
240562|NCT01427504|P3|Participant Flow|Sequence 2a|Sequence 2,1,3: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
240563|NCT01427504|P2|Participant Flow|Sequence 1b|Sequence 1,3,2: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
240564|NCT01427504|P1|Participant Flow|Sequence 1a|Sequence 1,2,3: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
240565|NCT01427504|O1|Outcome|Etravirine Cmin Coadministered With Boceprevir|Geometric mean ratio of etravirine Cmin when coadministered with boceprevir
240566|NCT01427504|O1|Outcome|Etravirine Cmax|Geometric mean ratio of etravirine Cmax when coadministered with boceprevir
240567|NCT01427504|O1|Outcome|Etravirine AUC Coadministered With Boceprevir|Geometric mean ratio of etravirine AUC when coadministered with boceprevir
240568|NCT01427504|O1|Outcome|Boceprevir C8 Coadministered With Etravirine|Geometric mean ratio of boceprevir C8 when coadministered with etravirine
240569|NCT01427504|O1|Outcome|Boceprevir Cmax Coadministered With Etravirine|Geometric mean ratio of boceprevir Cmax when coadministered with etravirine
240570|NCT01427504|O1|Outcome|Boceprevir AUC Coadministered With Etravirine|Geometric mean ratio of boceprevir AUC when coadministered with etravirine
240571|NCT01427504|O1|Outcome|Etravirine Cmin|Geometric mean of etravirine Cmin when administered alone.
240572|NCT01427504|O1|Outcome|Etravirine Cmax|Geometric mean of etravirine Cmax when administered alone.
240573|NCT01427504|O1|Outcome|Etravirine AUC|Geometric mean of etravirine AUC when administered alone.
240574|NCT01427504|O1|Outcome|Boceprevir C8|Geometric mean of boceprevir Cmax when administered alone.
240575|NCT01427504|O1|Outcome|Boceprevir Cmax|Geometric mean of boceprevir Cmax when administered alone.
240576|NCT01427504|O1|Outcome|Boceprevir AUC|Geometric mean of boceprevir AUC administered alone.
240577|NCT01427504|E3|Reported Event|Boceprevir Coadministered With Etravirine|Boceprevir, 800 mg thrice daily, coadministered with etravirine, 200 mg twice daily for 10-14 days.
240578|NCT01427504|E2|Reported Event|Etravirine Alone|Subjects took etravirine alone, 200 mg twice daily, for 10-14 days
240579|NCT01427504|E1|Reported Event|Boceprevir Alone|Subjects took boceprevir alone, 800 mg thrice daily, for 10-14 days.
240580|NCT01427309|B5|Baseline|Total|Total of all reporting groups
240581|NCT01427309|B4|Baseline|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
240582|NCT01427309|B3|Baseline|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
240583|NCT01427309|B2|Baseline|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
240584|NCT01427309|B1|Baseline|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
240585|NCT01427309|P4|Participant Flow|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
240586|NCT01427309|P3|Participant Flow|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
240587|NCT01427309|P2|Participant Flow|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
240588|NCT01427309|P1|Participant Flow|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
240589|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
240590|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
240591|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
240592|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
240593|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
240594|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
240595|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
240596|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
240597|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
240598|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
240599|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
240600|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
240601|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
240606|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
240607|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
240608|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
240609|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
240610|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
240611|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
240612|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
240613|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
240614|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
240615|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
240616|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
240617|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
240618|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
240619|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
240620|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
240621|NCT01427309|E4|Reported Event|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
240622|NCT01427309|E3|Reported Event|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
240623|NCT01427309|E2|Reported Event|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
240624|NCT01427309|E1|Reported Event|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
240625|NCT01427296|B3|Baseline|Total|Total of all reporting groups
240626|NCT01427296|B2|Baseline|HalfLytely and Bisacodyl Tablet|Polyethylene glycol: HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L
240627|NCT01427296|B1|Baseline|OsmoPrep Tablets|Oral sodium phosphate solution: OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
240628|NCT01427296|P2|Participant Flow|HalfLytely and Bisacodyl Tablet|Polyethylene glycol: HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L
240629|NCT01427296|P1|Participant Flow|OsmoPrep Tablets|Oral sodium phosphate solution: OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
240630|NCT01427296|O2|Outcome|HalfLytely and Bisacodyl Tablet|Polyethylene glycol: HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L
240631|NCT01427296|O1|Outcome|OsmoPrep Tablets|Oral sodium phosphate solution: OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
240632|NCT01427296|E2|Reported Event|HalfLytely and Bisacodyl Tablet|Polyethylene glycol: HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L
240633|NCT01427296|E1|Reported Event|OsmoPrep Tablets|Oral sodium phosphate solution: OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
240634|NCT01426958|B1|Baseline|Overall Study|This is an open-label, randomized, three-way crossover clinical phase I trial in healthy volunteers.
240635|NCT01426958|P1|Participant Flow|All Participants|This is an open-label, randomized, three-way crossover clinical phase I trial in healthy volunteers.
240636|NCT01426958|O3|Outcome|Afatinib + Timed Rtv|Subjects were treated with Rtv 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 six hours prior to third Rtv dose.
240637|NCT01426958|O2|Outcome|Afatinib + Concomittant Rtv|Subjects were treated with Ritonavir (Rtv) 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 with third Rtv dose.
240638|NCT01426958|O1|Outcome|Afatinib|Subjects were treated with a single dose of Afatinib 40mg on Day 1.
240639|NCT01426958|O3|Outcome|Afatinib + Timed Rtv|Subjects were treated with Rtv 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 six hours prior to third Rtv dose.
240640|NCT01426958|O2|Outcome|Afatinib + Concomittant Rtv|Subjects were treated with Ritonavir (Rtv) 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 with third Rtv dose.
240641|NCT01426958|O1|Outcome|Afatinib|Subjects were treated with a single dose of Afatinib 40mg on Day 1.
240642|NCT01426958|O3|Outcome|Afatinib + Timed Rtv|Subjects were treated with Rtv 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 six hours prior to third Rtv dose.
240643|NCT01426958|O2|Outcome|Afatinib + Concomittant Rtv|Subjects were treated with Ritonavir (Rtv) 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 with third Rtv dose.
240644|NCT01426958|O1|Outcome|Afatinib|Subjects were treated with a single dose of Afatinib 40mg on Day 1.
240645|NCT01426958|E3|Reported Event|Afatinib + Timed Rtv|Subjects were treated with Rtv 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 six hours prior to third Rtv dose.
240646|NCT01426958|E2|Reported Event|Afatinib + Concomittant Rtv|Subjects were treated with Ritonavir (Rtv) 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 with third Rtv dose.
240647|NCT01426958|E1|Reported Event|Afatinib|Subjects were treated with a single dose of Afatinib 40mg on Day 1.
240649|NCT01426867|B3|Baseline|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
240650|NCT01426867|B2|Baseline|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
240651|NCT01426867|B1|Baseline|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
240652|NCT01426867|P3|Participant Flow|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
240653|NCT01426867|P2|Participant Flow|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
240654|NCT01426867|P1|Participant Flow|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
240655|NCT01426867|O3|Outcome|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
240656|NCT01426867|O2|Outcome|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
240657|NCT01426867|O1|Outcome|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
240658|NCT01426867|E3|Reported Event|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
240659|NCT01426867|E2|Reported Event|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
240660|NCT01426867|E1|Reported Event|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
240661|NCT01426854|B3|Baseline|Total|Total of all reporting groups
240662|NCT01426854|B2|Baseline|Placebo|Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
240663|NCT01426854|B1|Baseline|Nepafenac|Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
240664|NCT01426854|P2|Participant Flow|Placebo|Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
240665|NCT01426854|P1|Participant Flow|Nepafenac|Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
240666|NCT01426854|O2|Outcome|Placebo|Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
240667|NCT01426854|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
240668|NCT01426854|O2|Outcome|Placebo|Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
240669|NCT01426854|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
240670|NCT01426854|E2|Reported Event|Placebo|Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
240671|NCT01426854|E1|Reported Event|Nepafenac|Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
240672|NCT01426789|B3|Baseline|Total|Total of all reporting groups
240673|NCT01426789|B2|Baseline|Placebo|Placebo i.v.
240674|NCT01426789|B1|Baseline|Secukinumab|10 mg/kg intravenous (I.V.)
240675|NCT01426789|P6|Participant Flow|Group 4|Part 1: placebo; Part 2: no study treatment
240676|NCT01426789|P5|Participant Flow|Group 3|Part 1: placebo; Part 2: secukinumab 4 x 300 mg sc loading dose (at weeks 12, 13, 14 and 16), then 300 mg sc monthly
240677|NCT01426789|P4|Participant Flow|Group 2|Part 1: secukinumab 6 x 10 mg/kg i.v.; part 2: no study treatment
240678|NCT01426789|P3|Participant Flow|Group 1|Part 1: secukinumab 6 x 10 mg/kg i.v.; Part 2: secukinumab 300 mg sc monthly
240679|NCT01426789|P2|Participant Flow|Placebo|Placebo i.v.
240680|NCT01426789|P1|Participant Flow|Secukinumab|10 mg/kg intravenous (I.V.)
240681|NCT01426789|O2|Outcome|Placebo|Placebo i.v.
240682|NCT01426789|O1|Outcome|Secukinumab|10 mg/kg intravenous (I.V.)
240683|NCT01426789|O2|Outcome|Placebo|Placebo i.v.
240684|NCT01426789|O1|Outcome|Secukinumab|10 mg/kg intravenous (I.V.)
240685|NCT01426789|O2|Outcome|Placebo|Placebo i.v.
240686|NCT01426789|O1|Outcome|Secukinumab|10 mg/kg intravenous (I.V.)
240687|NCT01426789|O2|Outcome|Placebo|Placebo i.v.
240688|NCT01426789|O1|Outcome|Secukinumab|10 mg/kg intravenous (I.V.)
240689|NCT01426789|E4|Reported Event|Group 3|Part 1: placebo; Part 2: secukinumab 4 x 300 mg sc loading dose (at weeks 12, 13, 14 and 16), then 300 mg sc monthly
240690|NCT01426789|E3|Reported Event|Group 1|Part 1: secukinumab 6 x 10 mg/kg i.v.; Part 2: secukinumab 300 mg sc monthly
240691|NCT01426789|E2|Reported Event|Placebo|Placebo i.v.
240692|NCT01426789|E1|Reported Event|Secukinumab|10mg/kg i.v.
240693|NCT01426763|B3|Baseline|Total|Total of all reporting groups
240694|NCT01426763|B2|Baseline|SC CINRYZE With rHuPH20 Dose Level 2|Subcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks
241135|NCT01425801|O4|Outcome|LAS100977 1.25 μg|Dry powder for inhalation administered via Genuair®
240695|NCT01426763|B1|Baseline|SC CINRYZE With rHuPH20 Dose Level 1|Subcutaneous injection of 1000 Units of CINRYZE with 20,000 Units of rHuPH20 twice weekly for two weeks
240696|NCT01426763|P2|Participant Flow|SC CINRYZE With rHuPH20 Dose Level 2|Subcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks
240697|NCT01426763|P1|Participant Flow|SC CINRYZE With rHuPH20 Dose Level 1|Subcutaneous (SC) injection of 1000 Units of CINRYZE with 20,000 Units of recombinant human hyaluronidase (rHuPH20) twice weekly for two weeks
240698|NCT01426763|O2|Outcome|SC CINRYZE With rHuPH20 Dose Level 2|Subcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks
240699|NCT01426763|O1|Outcome|SC CINRYZE With rHuPH20 Dose Level 1|Subcutaneous injection of 1000 Units of CINRYZE with 20,000 Units of rHuPH20 twice weekly for two weeks
240700|NCT01426763|E2|Reported Event|SC CINRYZE With rHuPH20 Dose Level 2|Subcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks
240701|NCT01426763|E1|Reported Event|SC CINRYZE With rHuPH20 Dose Level 1|Subcutaneous injection of 1000 Units of CINRYZE with 20,000 Units of rHuPH20 twice weekly for two weeks
240702|NCT01426555|B3|Baseline|Total|Total of all reporting groups
240703|NCT01426555|B2|Baseline|Rowing Arm|Thirty five subjects, in each arm age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were enrolled.
240704|NCT01426555|B1|Baseline|ZA Infusion Arm|Thirty five subjects in each arm, age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were enrolled.
240705|NCT01426555|P2|Participant Flow|ZA Infusion Arm|"Prior to FES-row, subjects undertook a 2 -12 weeks strength-training program at SRH, depending on how the subjects respond to the FES-strength training. Subjects who completed strength training, progressed to rowing.~In the FES-Rowing program, the goal was for each subject to achieve an exercise intensity of 75-85% maintained for a continuous 40 minutes performed 3 times each week in additional to maintaining strength training at home on days when they are not rowing.~After the observation period, subjects in the FES rowing plus zoledronic acid arm were planned to receive Zoledronic Acid (Reclast ®) administered as a dose of 5mg intravenously.~All subjects received a daily minimum supplementation of 1000mg Calcium & 1000 IUs of Vitamin-D supplementation during the duration of the program."
240706|NCT01426555|P1|Participant Flow|Rowing Arm|"Prior to FES-row, subjects undertook a 2 -12 weeks strength-training program at SRH, depending on how the subjects respond to the FES-strength training. Subjects who completed strength training, progressed to rowing.~In the FES-Rowing program, the goal was for each subject to achieve an exercise intensity of 75-85% maintained for a continuous 40 minutes performed 3 times each week in additional to maintaining strength training at home on days when they are not rowing.~All subjects received a daily minimum supplementation of 1000mg Calcium & 1000 IUs of Vitamin-D supplementation during the duration of the program."
240707|NCT01426555|O2|Outcome|Rowing Arm|"Thirty Five subjects, in each arm age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI, enrolled.~Dataset unavailable for analysis to VABHS study team. The study was closed by the VABHS IRB."
240708|NCT01426555|O1|Outcome|ZA Infusion Arm|"Thirty Five subjects in each arm, age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI, were enrolled.~Dataset unavailable for analysis to VABHS study team. The study was closed by the VABHS IRB."
240709|NCT01426555|O2|Outcome|Rowing Arm|"Thirty Five subjects, in each arm age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were planned to be enrolled.~No Data was analyzed because dataset is not available to VABHS Study team."
240710|NCT01426555|O1|Outcome|ZA Infusion Arm|"Thirty Five subjects in each arm, age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were planned to be enrolled.~No Data was analyzed because dataset is not available to VABHS Study team."
240711|NCT01426555|E2|Reported Event|Rowing Arm|No adverse event data were available for the remaining 16 participants.
240712|NCT01426555|E1|Reported Event|ZA Infusion Arm|No adverse event data were available for the remaining 9 participants.
240713|NCT01426516|B3|Baseline|Total|Total of all reporting groups
240714|NCT01426516|B2|Baseline|Genecept Assay|"Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account.~Genecept Assay: Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders"
240715|NCT01426516|B1|Baseline|Treatment as Usual (TAU)|Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.
240716|NCT01426516|P2|Participant Flow|Genecept Assay|"Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account.~Genecept Assay: Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders"
240717|NCT01426516|P1|Participant Flow|Treatment as Usual (TAU)|Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.
240718|NCT01426516|O2|Outcome|Genecept Assay|"Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account.~Genecept Assay: Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders"
240719|NCT01426516|O1|Outcome|Treatment as Usual (TAU)|Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.
240720|NCT01426516|E2|Reported Event|Genecept Assay|"Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account.~Genecept Assay: Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders"
240721|NCT01426516|E1|Reported Event|Treatment as Usual (TAU)|Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.
240722|NCT01426438|B3|Baseline|Total|Total of all reporting groups
240723|NCT01426438|B2|Baseline|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
240724|NCT01426438|B1|Baseline|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
240725|NCT01426438|P2|Participant Flow|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
240726|NCT01426438|P1|Participant Flow|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
240727|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
240728|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
240729|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
240730|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
240731|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
240732|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
240733|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
240734|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
240735|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
240736|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
240737|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
240738|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
240739|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
240740|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
240741|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
240742|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
240743|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
240744|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
240745|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
240746|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
240747|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
240748|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
240749|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
240750|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
240751|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
240785|NCT01426360|O1|Outcome|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
240752|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
240753|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
240754|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
240755|NCT01426438|E2|Reported Event|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
240756|NCT01426438|E1|Reported Event|Arm A: Extended-release Niacin With Aspirin|Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24) Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24.
240757|NCT01426425|B1|Baseline|mITT Set|The modified intent-to-treat (mITT) set.
240758|NCT01426425|P1|Participant Flow|All Participants|All subjects enrolled into the study.
240759|NCT01426425|O1|Outcome|mITT Subjects With Acute Procedural Success|The modified intent-to-treat (mITT) subjects who had acute procedural success with cryoablation for the treatment of AVNRT.
240760|NCT01426425|O1|Outcome|mITT Set|The modified intent-to-treat (mITT) set.
240761|NCT01426425|O1|Outcome|mITT Set|The modified intent-to-treat (mITT) set.
240762|NCT01426425|E1|Reported Event|mITT Set|Subjects in the modified intent-to-treat (mITT) set.
240763|NCT01426373|B1|Baseline|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
240764|NCT01426373|P1|Participant Flow|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
240765|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
240766|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
240767|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
240768|NCT01426373|O2|Outcome|Month 12 After Last Treatment|
240769|NCT01426373|O1|Outcome|Month 3 After Last Treatment|
240770|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
240771|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
240772|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
240773|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
240774|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
240775|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
240776|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
240777|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
240778|NCT01426373|E1|Reported Event|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
240779|NCT01426360|B3|Baseline|Total|Total of all reporting groups
240780|NCT01426360|B2|Baseline|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
240781|NCT01426360|B1|Baseline|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
240782|NCT01426360|P2|Participant Flow|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
240783|NCT01426360|P1|Participant Flow|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
240784|NCT01426360|O2|Outcome|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
263764|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
240786|NCT01426360|O2|Outcome|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
240787|NCT01426360|O1|Outcome|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
240788|NCT01426360|O2|Outcome|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
240789|NCT01426360|O1|Outcome|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
240790|NCT01426360|O2|Outcome|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
240791|NCT01426360|O1|Outcome|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
240792|NCT01426360|E2|Reported Event|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
240793|NCT01426360|E1|Reported Event|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
240794|NCT01426347|B3|Baseline|Total|Total of all reporting groups
240795|NCT01426347|B2|Baseline|Ergocalciferol|"Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.~Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks"
240796|NCT01426347|B1|Baseline|Placebo Group|"RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms.~Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.~Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule."
240797|NCT01426347|P2|Participant Flow|Ergocalciferol|"Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.~Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks"
240798|NCT01426347|P1|Participant Flow|Placebo Group|"Rheumatoid Arthritis (RA) patients with vitamin D deficiency will be randomized to placebo and active intervention arms.~Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.~Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule."
240799|NCT01426347|O2|Outcome|Ergocalciferol|"Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.~Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks"
240800|NCT01426347|O1|Outcome|Placebo Group|"RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms.~Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.~Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule."
240801|NCT01426347|O2|Outcome|Ergocalciferol|"Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.~Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks"
240802|NCT01426347|O1|Outcome|Placebo Group|"RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms.~Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.~Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule."
240803|NCT01426347|E2|Reported Event|Ergocalciferol|"Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.~Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks"
240804|NCT01426347|E1|Reported Event|Placebo Group|"RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms.~Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.~Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule."
240805|NCT01426269|B1|Baseline|Period 1: Oral Doxycycline and Topical Metronidazole|"Subjects will receive oral doxycycline and topical metronidazole during period 1 (12 weeks)~Oral Doxycycline and Topical Metronidazole: period 1, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning and MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area"
240806|NCT01426269|P3|Participant Flow|Placebo|"Subjects will receive placebo during phase 2 (week 12 – week 52)~Placebo: During phase 2 (week 12 - week 52): placebo, oral, one capsule daily in the morning"
240807|NCT01426269|P2|Participant Flow|Oral Doxycycline|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during phase 2 (week 12 - week 52)~Oral Doxycycline: During phase 2 week 12 - week 52: Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
240808|NCT01426269|P1|Participant Flow|Doxycycline and Metronidazole Regimen|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)~Oral Doxycycline and Topical Metronidazole: During phase 1 (baseline - week 12): Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning and MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area.~After Period 1, subjects who meet criteria for phase 2 will be randomized to receive doxycycline or placebo during phase 2"
240838|NCT01426230|O1|Outcome|Open Label - Cohort >70 Yrs Old|"Cohort by age-~- Patients >70 Yrs old"
240809|NCT01426269|O4|Outcome|Week 12|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
240810|NCT01426269|O3|Outcome|Week 8|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
240811|NCT01426269|O2|Outcome|Week 4|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
240812|NCT01426269|O1|Outcome|Baseline|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
240813|NCT01426269|O4|Outcome|Week 12|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
240814|NCT01426269|O3|Outcome|Week 8|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
240815|NCT01426269|O2|Outcome|Week 4|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
240816|NCT01426269|O1|Outcome|Baseline|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
240817|NCT01426269|O4|Outcome|Week 12|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
240818|NCT01426269|O3|Outcome|Week 8|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
240819|NCT01426269|O2|Outcome|Week 4|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
240820|NCT01426269|O1|Outcome|Baseline|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
240821|NCT01426269|O2|Outcome|Placebo|"Subjects will receive placebo during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Placebo: During period 2, placebo, oral, one capsule daily in the morning"
240822|NCT01426269|O1|Outcome|Oral Doxycycline|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Oral Doxycycline: During period 2, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
240823|NCT01426269|O2|Outcome|Placebo|"Subjects will receive placebo during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Placebo: During period 2, placebo, oral, one capsule daily in the morning"
240824|NCT01426269|O1|Outcome|Oral Doxycycline|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Oral Doxycycline: During period 2, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
240825|NCT01426269|O2|Outcome|Placebo|"Subjects will receive placebo during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Placebo: During period 2, placebo, oral, one capsule daily in the morning"
240826|NCT01426269|O1|Outcome|Oral Doxycycline|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Oral Doxycycline: During period 2, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
240827|NCT01426269|O2|Outcome|Placebo|"Subjects will receive placebo during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Placebo: During period 2, placebo, oral, one capsule daily in the morning"
240828|NCT01426269|O1|Outcome|Oral Doxycycline|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Oral Doxycycline: During period 2, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
240829|NCT01426269|E3|Reported Event|Period 2: Placebo|"Subjects will receive placebo during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Placebo: period 2, placebo, oral, one capsule daily in the morning"
240830|NCT01426269|E2|Reported Event|Period 2: Oral Doxycycline|"Subjects will receive oral doxycycline during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Oral Doxycycline: period 2, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
240831|NCT01426269|E1|Reported Event|Period 1: Oral Doxycycline and Topical Metronidazole|"Subjects will receive oral doxycycline and topical metronidazole during period 1 (12 weeks)~Oral Doxycycline and Topical Metronidazole: period 1, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning and MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area"
240832|NCT01426230|B3|Baseline|Total|Total of all reporting groups
240833|NCT01426230|B2|Baseline|Open Label - Cohort <=70 Yrs Old|"Cohort by age-~- Patients <=70 Yrs old"
240834|NCT01426230|B1|Baseline|Open Label - Cohort >70 Yrs Old|"Cohort by age-~- Patients >70 Yrs old"
240835|NCT01426230|P2|Participant Flow|Open Label - Cohort <=70 Yrs Old|"Cohort by age-~- Patients <=70 Yrs old"
240836|NCT01426230|P1|Participant Flow|Open Label - Cohort >70 Yrs Old|"Cohort by age-~- Patients >70 Yrs old"
240837|NCT01426230|O2|Outcome|Open Label - Cohort <=70 Yrs Old|"Cohort by age-~- Patients <=70 Yrs old"
240841|NCT01426113|B2|Baseline|Timolol Ophthalmic Solution|1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
240842|NCT01426113|B1|Baseline|Bimatoprost Ophthalmic Solution Formulation A and Vehicle|1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
240843|NCT01426113|P2|Participant Flow|Timolol Ophthalmic Solution|1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
240844|NCT01426113|P1|Participant Flow|Bimatoprost Ophthalmic Solution Formulation A and Vehicle|1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
240845|NCT01426113|O2|Outcome|Timolol Ophthalmic Solution|1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
240846|NCT01426113|O1|Outcome|Bimatoprost Ophthalmic Solution Formulation A and Vehicle|1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
240847|NCT01426113|E2|Reported Event|Timolol Ophthalmic Solution|1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
240848|NCT01426113|E1|Reported Event|Bimatoprost Ophthalmic Solution Formulation A and Vehicle|1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
240849|NCT01426009|B1|Baseline|Total Particiants|total of all participants in the study
240850|NCT01426009|P1|Participant Flow|Total|"total subjects which includes:EP-101 via nebulizer (eFlow®), Tiotropium bromide via (Spiriva® Handihaler®), Ipratropium bromide Inhalation Solution via Handihaler® DPI , and Placebo EP-101,"
240851|NCT01426009|O6|Outcome|Tiotropium Bromide Via (Spiriva® Handihaler®)|"Tiotropium bromide via (Spiriva® Handihaler®)~Tiotropium bromide via (Spiriva® Handihaler®): Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI"
240852|NCT01426009|O5|Outcome|Ipratropium Bromide Inhalation Solution|"Ipratropium bromide Inhalation Solution via Handihaler® DPI~Ipratropium bromide Inhalation Solution via Handihaler® DPI: Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer"
240853|NCT01426009|O4|Outcome|EP-101 Via Nebulizer (eFlow®) 200 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240854|NCT01426009|O3|Outcome|EP-101 Via Nebulizer (eFlow®)100 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240855|NCT01426009|O2|Outcome|EP-101 Via Nebulizer (eFlow®) 50 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240856|NCT01426009|O1|Outcome|EP-101 Via Nebulizer (eFlow®) 25 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240857|NCT01426009|O7|Outcome|Placebo|"Placebo~Placebo : Placebo administered once daily for 7 days"
240858|NCT01426009|O6|Outcome|Tiotropium Bromide Via (Spiriva® Handihaler®)|"Tiotropium bromide via (Spiriva® Handihaler®)~Tiotropium bromide via (Spiriva® Handihaler®): Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI"
240859|NCT01426009|O5|Outcome|Ipratropium Bromide Inhalation Solution|"Ipratropium bromide Inhalation Solution via Handihaler® DPI~Ipratropium bromide Inhalation Solution via Handihaler® DPI: Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer"
240860|NCT01426009|O4|Outcome|EP-101 Via Nebulizer (eFlow®) 200 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240861|NCT01426009|O3|Outcome|EP-101 Via Nebulizer (eFlow®)100 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240862|NCT01426009|O2|Outcome|EP-101 Via Nebulizer (eFlow®) 50 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240863|NCT01426009|O1|Outcome|EP-101 Via Nebulizer (eFlow®) 25 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240864|NCT01426009|O7|Outcome|Placebo|"Placebo~Placebo : Placebo administered once daily for 7 days"
240865|NCT01426009|O6|Outcome|Tiotropium Bromide Via (Spiriva® Handihaler®)|"Tiotropium bromide via (Spiriva® Handihaler®)~Tiotropium bromide via (Spiriva® Handihaler®): Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI"
240866|NCT01426009|O5|Outcome|Ipratropium Bromide Inhalation Solution|"Ipratropium bromide Inhalation Solution via Handihaler® DPI~Ipratropium bromide Inhalation Solution via Handihaler® DPI: Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer"
240867|NCT01426009|O4|Outcome|EP-101 Via Nebulizer (eFlow®) 200 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240868|NCT01426009|O3|Outcome|EP-101 Via Nebulizer (eFlow®)100 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240869|NCT01426009|O2|Outcome|EP-101 Via Nebulizer (eFlow®) 50 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240870|NCT01426009|O1|Outcome|EP-101 Via Nebulizer (eFlow®) 25 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240871|NCT01426009|O6|Outcome|Tiotropium Bromide Via (Spiriva® Handihaler®)|"Tiotropium bromide via (Spiriva® Handihaler®)~Tiotropium bromide via (Spiriva® Handihaler®): Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI"
240872|NCT01426009|O5|Outcome|Ipratropium Bromide Inhalation Solution|"Ipratropium bromide Inhalation Solution via Handihaler® DPI~Ipratropium bromide Inhalation Solution via Handihaler® DPI: Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer"
240873|NCT01426009|O4|Outcome|EP-101 Via Nebulizer (eFlow®) 200 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240874|NCT01426009|O3|Outcome|EP-101 Via Nebulizer (eFlow®)100 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240875|NCT01426009|O2|Outcome|EP-101 Via Nebulizer (eFlow®) 50 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240876|NCT01426009|O1|Outcome|EP-101 Via Nebulizer (eFlow®) 25 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240877|NCT01426009|O7|Outcome|Placebo|"Placebo~Placebo : Placebo administered once daily for 7 days"
240878|NCT01426009|O6|Outcome|Tiotropium Bromide Via (Spiriva® Handihaler®)|"Tiotropium bromide via (Spiriva® Handihaler®)~Tiotropium bromide via (Spiriva® Handihaler®): Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI"
240879|NCT01426009|O5|Outcome|Ipratropium Bromide Inhalation Solution|"Ipratropium bromide Inhalation Solution via Handihaler® DPI~Ipratropium bromide Inhalation Solution via Handihaler® DPI: Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer"
240880|NCT01426009|O4|Outcome|EP-101 Via Nebulizer (eFlow®) 200 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240881|NCT01426009|O3|Outcome|EP-101 Via Nebulizer (eFlow®)100 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240882|NCT01426009|O2|Outcome|EP-101 Via Nebulizer (eFlow®) 50 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240883|NCT01426009|O1|Outcome|EP-101 Via Nebulizer (eFlow®) 25 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240884|NCT01426009|O7|Outcome|Placebo|"Placebo~Placebo : Placebo administered once daily for 7 days"
240885|NCT01426009|O6|Outcome|Tiotropium Bromide Via (Spiriva® Handihaler®)|"Tiotropium bromide via (Spiriva® Handihaler®)~Tiotropium bromide via (Spiriva® Handihaler®): Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI"
240886|NCT01426009|O5|Outcome|Ipratropium Bromide Inhalation Solution|"Ipratropium bromide Inhalation Solution via Handihaler® DPI~Ipratropium bromide Inhalation Solution via Handihaler® DPI: Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer"
240887|NCT01426009|O4|Outcome|EP-101 Via Nebulizer (eFlow®) 200 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240888|NCT01426009|O3|Outcome|EP-101 Via Nebulizer (eFlow®)100 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240889|NCT01426009|O2|Outcome|EP-101 Via Nebulizer (eFlow®) 50 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240890|NCT01426009|O1|Outcome|EP-101 Via Nebulizer (eFlow®) 25 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240891|NCT01426009|O7|Outcome|Placebo|"Placebo~Placebo : Placebo administered once daily for 7 days"
240892|NCT01426009|O6|Outcome|Tiotropium Bromide Via (Spiriva® Handihaler®)|"Tiotropium bromide via (Spiriva® Handihaler®)~Tiotropium bromide via (Spiriva® Handihaler®): Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI"
240893|NCT01426009|O5|Outcome|Ipratropium Bromide Inhalation Solution|"Ipratropium bromide Inhalation Solution via Handihaler® DPI~Ipratropium bromide Inhalation Solution via Handihaler® DPI: Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer"
240894|NCT01426009|O4|Outcome|EP-101 Via Nebulizer (eFlow®) 200 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240895|NCT01426009|O3|Outcome|EP-101 Via Nebulizer (eFlow®)100 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240896|NCT01426009|O2|Outcome|EP-101 Via Nebulizer (eFlow®) 50 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240897|NCT01426009|O1|Outcome|EP-101 Via Nebulizer (eFlow®) 25 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240898|NCT01426009|E7|Reported Event|Placebo|"Placebo~Placebo : Placebo administered once daily for 7 days"
240899|NCT01426009|E6|Reported Event|Tiotropium Bromide Via (Spiriva® Handihaler®)|"Tiotropium bromide via (Spiriva® Handihaler®)~Tiotropium bromide via (Spiriva® Handihaler®): Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI"
240900|NCT01426009|E5|Reported Event|Ipratropium Bromide Inhalation Solution|"Ipratropium bromide Inhalation Solution via Handihaler® DPI~Ipratropium bromide Inhalation Solution via Handihaler® DPI: Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer"
240901|NCT01426009|E4|Reported Event|EP-101 Via Nebulizer (eFlow®) 200 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240902|NCT01426009|E3|Reported Event|EP-101 Via Nebulizer (eFlow®)100 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240903|NCT01426009|E2|Reported Event|EP-101 Via Nebulizer (eFlow®) 50 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240904|NCT01426009|E1|Reported Event|EP-101 Via Nebulizer (eFlow®) 25 mcg|"EP-101 via nebulizer (eFlow®)~EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days~EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days"
240905|NCT01425879|B1|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
240906|NCT01425879|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
240907|NCT01425879|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
240908|NCT01425879|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
240909|NCT01425879|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
240910|NCT01425879|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
240911|NCT01425879|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
240912|NCT01425853|B3|Baseline|Total|Total of all reporting groups
240913|NCT01425853|B2|Baseline|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
240914|NCT01425853|B1|Baseline|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. Anatomical Therapeutic Chemical Classification System (ATC) code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
240915|NCT01425853|P2|Participant Flow|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
240916|NCT01425853|P1|Participant Flow|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
240917|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
240918|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. Anatomical Therapeutic Chemical Classification System (ATC) code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
240919|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
240920|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. Anatomical Therapeutic Chemical Classification System (ATC) code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
240921|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
240922|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. Anatomical Therapeutic Chemical Classification System (ATC) code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
240923|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
240924|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
240925|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
240926|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
240927|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
240928|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
240929|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
240930|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
240931|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
240932|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
240933|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
240934|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
240935|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
240936|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
240937|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
240938|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
240939|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
240940|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
240941|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
240942|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
240943|NCT01425853|E2|Reported Event|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
240944|NCT01425853|E1|Reported Event|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
240945|NCT01425814|B1|Baseline|Overall Population|All patients who were randomized and received at least one dose of investigational medicinal product
240946|NCT01425814|P6|Participant Flow|Sequence F|Placebo - Indacaterol 150 μg - LAS100977 5 μg - LAS100977 10 μg - LAS100977 2.5 μg - LAS100977 0.625 μg
240947|NCT01425814|P5|Participant Flow|Sequence E|LAS100977 5 μg - Placebo - LAS100977 2.5 μg - Indacaterol 150 μg - LAS100977 0.625 μg - LAS100977 10 μg
240948|NCT01425814|P4|Participant Flow|Sequence D|LAS100977 2.5 μg - LAS100977 5 μg - LAS100977 0.625 μg - Placebo - LAS100977 10 μg - Indacaterol 150 μg
240949|NCT01425814|P3|Participant Flow|Sequence C|LAS100977 0.625 μg - LAS100977 2.5 μg - LAS100977 10 μg - LAS100977 5 μg - Indacaterol 150 μg - Placebo
240950|NCT01425814|P2|Participant Flow|Sequence B|LAS100977 10 μg - LAS100977 0.625 μg - Indacaterol 150 μg - LAS100977 2.5 μg - Placebo - LAS100977 5 μg
240951|NCT01425814|P1|Participant Flow|Sequence A|Indacaterol 150 μg - LAS100977 10 μg - Placebo - LAS100977 0.625 μg - LAS100977 5 μg- LAS100977 2.5 μg
240952|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
240953|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
240954|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
240955|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
240956|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
240957|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
240958|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
240959|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
240960|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
240961|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
240962|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
240963|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
240964|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
240965|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
240966|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
240967|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
240968|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
240969|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
240970|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
240971|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
240972|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
240973|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
240974|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
240975|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
240976|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
240977|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
240978|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
240979|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
240980|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
240981|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
240982|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
240983|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
240984|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
240985|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
240986|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
240987|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
240988|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
240989|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
240990|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
240991|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
240992|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
240993|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
240994|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
240995|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
240996|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
240997|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
240998|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
240999|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
241000|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
241001|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
241002|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
241003|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
241004|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
241005|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
241006|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
241007|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
241008|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
241009|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
241010|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
241011|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
241012|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
241013|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
241014|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
241015|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
241016|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
241017|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
241018|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
241019|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
241020|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
241021|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
241022|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
241023|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
241024|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
241025|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
241026|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
241027|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
241028|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
241029|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
241030|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
241031|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
241032|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
241033|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
241034|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
241035|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
241036|NCT01425814|E6|Reported Event|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
241037|NCT01425814|E5|Reported Event|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
241038|NCT01425814|E4|Reported Event|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
241039|NCT01425814|E3|Reported Event|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
241040|NCT01425814|E2|Reported Event|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
241041|NCT01425814|E1|Reported Event|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
241042|NCT01425801|B1|Baseline|Overall Population|Safety population defined as all patients who were randomized and received at least one dose of investigational medicinal product
241043|NCT01425801|P6|Participant Flow|Sequence F|Placebo - Salbutamol 400 μg - LAS100977 2.5 μg - LAS100977 0.313 μg - LAS100977 1.25 μg - LAS100977 0.625 μg
241044|NCT01425801|P5|Participant Flow|Sequence E|LAS100977 2.5 μg - Placebo - LAS100977 1.25 μg - Salbutamol 400 μg - LAS100977 0.625 μg - LAS100977 0.313 μg
241045|NCT01425801|P4|Participant Flow|Sequence D|LAS100977 1.25 μg - LAS100977 2.5 μg - LAS100977 0.625 μg - Placebo - LAS100977 0.313 μg - Salbutamol 400 μg
241046|NCT01425801|P3|Participant Flow|Sequence C|LAS100977 0.625 μg - LAS100977 1.25 μg - LAS100977 0.313 μg - LAS100977 2.5 μg - Salbutamol 400 μg - Placebo
241047|NCT01425801|P2|Participant Flow|Sequence B|LAS100977 0.313 μg - LAS100977 0.625 μg - Salbutamol 400 μg - LAS100977 1.25 μg - Placebo - LAS100977 2.5 μg
241048|NCT01425801|P1|Participant Flow|Sequence A|Salbutamol 400 μg - LAS100977 0.313 μg - Placebo - LAS100977 0.625 μg - LAS100977 2.5 μg - LAS100977 1.25 μg
241049|NCT01425801|O6|Outcome|Salbutamol 400 μg|Pressurised inhalation suspension administered via Ventolin Evohaler®
241050|NCT01425801|O5|Outcome|LAS100977 2.5 μg|Dry powder for inhalation administered via Genuair®
241051|NCT01425801|O4|Outcome|LAS100977 1.25 μg|Dry powder for inhalation administered via Genuair®
241052|NCT01425801|O3|Outcome|LAS100977 0.625 μg|Dry powder for inhalation administered via Genuair®
241053|NCT01425801|O2|Outcome|LAS100977 0.313 μg|Dry powder administered via the Genuair® inhaler
241054|NCT01425801|O1|Outcome|Placebo|Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
241055|NCT01425801|O6|Outcome|Salbutamol 400 μg|Pressurised inhalation suspension administered via Ventolin Evohaler®
241056|NCT01425801|O5|Outcome|LAS100977 2.5 μg|Dry powder for inhalation administered via Genuair®
241057|NCT01425801|O4|Outcome|LAS100977 1.25 μg|Dry powder for inhalation administered via Genuair®
241058|NCT01425801|O3|Outcome|LAS100977 0.625 μg|Dry powder for inhalation administered via Genuair®
241059|NCT01425801|O2|Outcome|LAS100977 0.313 μg|Dry powder administered via the Genuair® inhaler
241060|NCT01425801|O1|Outcome|Placebo|Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
241061|NCT01425801|O6|Outcome|Salbutamol 400 μg|Pressurised inhalation suspension administered via Ventolin Evohaler®
241062|NCT01425801|O5|Outcome|LAS100977 2.5 μg|Dry powder for inhalation administered via Genuair®
241063|NCT01425801|O4|Outcome|LAS100977 1.25 μg|Dry powder for inhalation administered via Genuair®
241064|NCT01425801|O3|Outcome|LAS100977 0.625 μg|Dry powder for inhalation administered via Genuair®
241065|NCT01425801|O2|Outcome|LAS100977 0.313 μg|Dry powder administered via the Genuair® inhaler
241066|NCT01425801|O1|Outcome|Placebo|Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
241067|NCT01425801|O6|Outcome|Salbutamol 400 μg|Pressurised inhalation suspension administered via Ventolin Evohaler®
241068|NCT01425801|O5|Outcome|LAS100977 2.5 μg|Dry powder for inhalation administered via Genuair®
241069|NCT01425801|O4|Outcome|LAS100977 1.25 μg|Dry powder for inhalation administered via Genuair®
241070|NCT01425801|O3|Outcome|LAS100977 0.625 μg|Dry powder for inhalation administered via Genuair®
241071|NCT01425801|O2|Outcome|LAS100977 0.313 μg|Dry powder administered via the Genuair® inhaler
241072|NCT01425801|O1|Outcome|Placebo|Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
241073|NCT01425801|O6|Outcome|Salbutamol 400 μg|Pressurised inhalation suspension administered via Ventolin Evohaler®
241078|NCT01425801|O1|Outcome|Placebo|Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
241079|NCT01425801|O6|Outcome|Salbutamol 400 μg|Pressurised inhalation suspension administered via Ventolin Evohaler®
241080|NCT01425801|O5|Outcome|LAS100977 2.5 μg|Dry powder for inhalation administered via Genuair®
241081|NCT01425801|O4|Outcome|LAS100977 1.25 μg|Dry powder for inhalation administered via Genuair®
241082|NCT01425801|O3|Outcome|LAS100977 0.625 μg|Dry powder for inhalation administered via Genuair®
241083|NCT01425801|O2|Outcome|LAS100977 0.313 μg|Dry powder administered via the Genuair® inhaler
241084|NCT01425801|O1|Outcome|Placebo|Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
241085|NCT01425801|O6|Outcome|Salbutamol 400 μg|Pressurised inhalation suspension administered via Ventolin Evohaler®
241086|NCT01425801|O5|Outcome|LAS100977 2.5 μg|Dry powder for inhalation administered via Genuair®
241087|NCT01425801|O4|Outcome|LAS100977 1.25 μg|Dry powder for inhalation administered via Genuair®
241088|NCT01425801|O3|Outcome|LAS100977 0.625 μg|Dry powder for inhalation administered via Genuair®
241089|NCT01425801|O2|Outcome|LAS100977 0.313 μg|Dry powder administered via the Genuair® inhaler
241090|NCT01425801|O1|Outcome|Placebo|Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
241091|NCT01425801|O6|Outcome|Salbutamol 400 μg|Pressurised inhalation suspension administered via Ventolin Evohaler®
241092|NCT01425801|O5|Outcome|LAS100977 2.5 μg|Dry powder for inhalation administered via Genuair®
241093|NCT01425801|O4|Outcome|LAS100977 1.25 μg|Dry powder for inhalation administered via Genuair®
241094|NCT01425801|O3|Outcome|LAS100977 0.625 μg|Dry powder for inhalation administered via Genuair®
241095|NCT01425801|O2|Outcome|LAS100977 0.313 μg|Dry powder administered via the Genuair® inhaler
241096|NCT01425801|O1|Outcome|Placebo|Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
241097|NCT01425801|O6|Outcome|Salbutamol 400 μg|Pressurised inhalation suspension administered via Ventolin Evohaler®
241098|NCT01425801|O5|Outcome|LAS100977 2.5 μg|Dry powder for inhalation administered via Genuair®
241099|NCT01425801|O4|Outcome|LAS100977 1.25 μg|Dry powder for inhalation administered via Genuair®
241100|NCT01425801|O3|Outcome|LAS100977 0.625 μg|Dry powder for inhalation administered via Genuair®
241101|NCT01425801|O2|Outcome|LAS100977 0.313 μg|Dry powder administered via the Genuair® inhaler
241102|NCT01425801|O1|Outcome|Placebo|Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
241103|NCT01425801|O6|Outcome|Salbutamol 400 μg|Pressurised inhalation suspension administered via Ventolin Evohaler®
241104|NCT01425801|O5|Outcome|LAS100977 2.5 μg|Dry powder for inhalation administered via Genuair®
241105|NCT01425801|O4|Outcome|LAS100977 1.25 μg|Dry powder for inhalation administered via Genuair®
241106|NCT01425801|O3|Outcome|LAS100977 0.625 μg|Dry powder for inhalation administered via Genuair®
241107|NCT01425801|O2|Outcome|LAS100977 0.313 μg|Dry powder administered via the Genuair® inhaler
241108|NCT01425801|O1|Outcome|Placebo|Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
241109|NCT01425801|O6|Outcome|Salbutamol 400 μg|Pressurised inhalation suspension administered via Ventolin Evohaler®
241110|NCT01425801|O5|Outcome|LAS100977 2.5 μg|Dry powder for inhalation administered via Genuair®
241111|NCT01425801|O4|Outcome|LAS100977 1.25 μg|Dry powder for inhalation administered via Genuair®
241112|NCT01425801|O3|Outcome|LAS100977 0.625 μg|Dry powder for inhalation administered via Genuair®
241113|NCT01425801|O2|Outcome|LAS100977 0.313 μg|Dry powder administered via the Genuair® inhaler
241114|NCT01425801|O1|Outcome|Placebo|Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
241115|NCT01425801|O6|Outcome|Salbutamol 400 μg|Pressurised inhalation suspension administered via Ventolin Evohaler®
241116|NCT01425801|O5|Outcome|LAS100977 2.5 μg|Dry powder for inhalation administered via Genuair®
241117|NCT01425801|O4|Outcome|LAS100977 1.25 μg|Dry powder for inhalation administered via Genuair®
241118|NCT01425801|O3|Outcome|LAS100977 0.625 μg|Dry powder for inhalation administered via Genuair®
241119|NCT01425801|O2|Outcome|LAS100977 0.313 μg|Dry powder administered via the Genuair® inhaler
241120|NCT01425801|O1|Outcome|Placebo|Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
241121|NCT01425801|O6|Outcome|Salbutamol 400 μg|Pressurised inhalation suspension administered via Ventolin Evohaler®
241122|NCT01425801|O5|Outcome|LAS100977 2.5 μg|Dry powder for inhalation administered via Genuair®
241123|NCT01425801|O4|Outcome|LAS100977 1.25 μg|Dry powder for inhalation administered via Genuair®
241124|NCT01425801|O3|Outcome|LAS100977 0.625 μg|Dry powder for inhalation administered via Genuair®
241125|NCT01425801|O2|Outcome|LAS100977 0.313 μg|Dry powder administered via the Genuair® inhaler
241126|NCT01425801|O1|Outcome|Placebo|Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
241127|NCT01425801|O6|Outcome|Salbutamol 400 μg|Pressurised inhalation suspension administered via Ventolin Evohaler®
241128|NCT01425801|O5|Outcome|LAS100977 2.5 μg|Dry powder for inhalation administered via Genuair®
241129|NCT01425801|O4|Outcome|LAS100977 1.25 μg|Dry powder for inhalation administered via Genuair®
241130|NCT01425801|O3|Outcome|LAS100977 0.625 μg|Dry powder for inhalation administered via Genuair®
241131|NCT01425801|O2|Outcome|LAS100977 0.313 μg|Dry powder administered via the Genuair® inhaler
241132|NCT01425801|O1|Outcome|Placebo|Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
241133|NCT01425801|O6|Outcome|Salbutamol 400 μg|Pressurised inhalation suspension administered via Ventolin Evohaler®
241136|NCT01425801|O3|Outcome|LAS100977 0.625 μg|Dry powder for inhalation administered via Genuair®
241137|NCT01425801|O2|Outcome|LAS100977 0.313 μg|Dry powder administered via the Genuair® inhaler
241138|NCT01425801|O1|Outcome|Placebo|Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
241139|NCT01425801|O6|Outcome|Salbutamol 400 μg|Pressurised inhalation suspension administered via Ventolin Evohaler®
241140|NCT01425801|O5|Outcome|LAS100977 2.5 μg|Dry powder for inhalation administered via Genuair®
241141|NCT01425801|O4|Outcome|LAS100977 1.25 μg|Dry powder for inhalation administered via Genuair®
241142|NCT01425801|O3|Outcome|LAS100977 0.625 μg|Dry powder for inhalation administered via Genuair®
241143|NCT01425801|O2|Outcome|LAS100977 0.313 μg|Dry powder administered via the Genuair® inhaler
241144|NCT01425801|O1|Outcome|Placebo|Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
241145|NCT01425801|E6|Reported Event|Salbutamol 400 μg|Pressurised inhalation suspension administered via Ventolin Evohaler®
241146|NCT01425801|E5|Reported Event|LAS100977 2.5 μg|Dry powder for inhalation administered via Genuair®
241147|NCT01425801|E4|Reported Event|LAS100977 1.25 μg|Dry powder for inhalation administered via Genuair®
241148|NCT01425801|E3|Reported Event|LAS100977 0.625 μg|Dry powder for inhalation administered via Genuair®
241149|NCT01425801|E2|Reported Event|LAS100977 0.313 μg|Dry powder administered via the Genuair® inhaler
241150|NCT01425801|E1|Reported Event|Placebo|Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler®
241151|NCT01425749|B3|Baseline|Total|Total of all reporting groups
241152|NCT01425749|B2|Baseline|Arm B|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
241153|NCT01425749|B1|Baseline|Arm A|"Intramuscular injections.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
241154|NCT01425749|P2|Participant Flow|Arm B: Intradermal/Subcutaneous Injections|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
241155|NCT01425749|P1|Participant Flow|Arm A: Intramuscular Injections|"Intramuscular injections.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
241156|NCT01425749|O1|Outcome|Arm B|"Intradermal/Subcutaneous injections of recMAGE-A3 + AS15 ASCI. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
241157|NCT01425749|O2|Outcome|Arm B|"Intradermal/Subcutaneous injections of recMAGE-A3 + AS15 ASCI. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
241158|NCT01425749|O1|Outcome|Arm A|"Intramuscular injections of recMAGE-A3 + AS15 ASCI.~recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
241159|NCT01425749|O2|Outcome|Arm B|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
241160|NCT01425749|O1|Outcome|Arm A|"Intramuscular injections.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
241161|NCT01425749|O2|Outcome|Arm B|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
241162|NCT01425749|O1|Outcome|Arm A|"Intramuscular injections.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
241163|NCT01425749|O2|Outcome|Arm B|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
241164|NCT01425749|O1|Outcome|Arm A|"Intramuscular injections.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
241165|NCT01425749|O2|Outcome|Arm B|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
241631|NCT01424306|O1|Outcome|Fructose Arm - Day 9|Gene expression measured on day 9 of fructose-sweetened beverage intervention period
241166|NCT01425749|O1|Outcome|Arm A|"Intramuscular injections.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
241167|NCT01425749|E2|Reported Event|Arm B|"Intradermal/Subcutaneous injections of recMAGE-A3 + AS15 ASCI. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
241168|NCT01425749|E1|Reported Event|Arm A|"Intramuscular injections of recMAGE-A3 + AS15 ASCI.~recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
241169|NCT01425632|B4|Baseline|Total|Total of all reporting groups
241170|NCT01425632|B3|Baseline|Placebo|TAU-284 placebo twice daily for 2 weeks
241171|NCT01425632|B2|Baseline|TAU-284 High|TAU-284 10mg twice daily for 2 weeks
241172|NCT01425632|B1|Baseline|TAU-284 Low|TAU-284 5mg twice daily for 2 weeks
241173|NCT01425632|P3|Participant Flow|Placebo|TAU-284 placebo twice daily for 2 weeks
241174|NCT01425632|P2|Participant Flow|TAU-284 High|TAU-284 10mg twice daily for 2 weeks
241175|NCT01425632|P1|Participant Flow|TAU-284 Low|TAU-284 5mg twice daily for 2 weeks
241176|NCT01425632|O3|Outcome|Placebo|TAU-284 placebo twice daily for 2 weeks
241177|NCT01425632|O2|Outcome|TAU-284 High|TAU-284 10mg twice daily for 2 weeks
241178|NCT01425632|O1|Outcome|TAU-284 Low|TAU-284 5mg twice daily for 2 weeks
241179|NCT01425632|E3|Reported Event|Placebo|TAU-284 placebo twice daily for 2 weeks
241180|NCT01425632|E2|Reported Event|TAU-284 High|TAU-284 10mg twice daily for 2 weeks
241181|NCT01425632|E1|Reported Event|TAU-284 Low|TAU-284 5mg twice daily for 2 weeks
241182|NCT01425528|B3|Baseline|Total|Total of all reporting groups
241183|NCT01425528|B2|Baseline|Cohort 2|"Participants in cohort 2 will be enrolled after the analysis of cohort 1 data has taken place. Dosing for cohort 2 will be based on results obtained in cohort 1.~Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
241184|NCT01425528|B1|Baseline|Cohort 1|"This cohort will be enrolled first. Analysis will be done to determine the optimum dosing of Kuvan to normalize BH4 levels in the Cerebral Spinal Fluid.~Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
241185|NCT01425528|P2|Participant Flow|Cohort 2|Participants in cohort 2 will be enrolled after the analysis of cohort 1 data has taken place. Dosing for cohort 2 will be based on results obtained in cohort 1.
241186|NCT01425528|P1|Participant Flow|Cohort 1|This cohort will be enrolled first. Analysis will be done to determine the optimum dosing of Kuvan to normalize BH4 levels in the Cerebral Spinal Fluid.
241187|NCT01425528|O2|Outcome|Cohort 2|"Participants in cohort 2 will be enrolled after the analysis of cohort 1 data has taken place. Dosing for cohort 2 will be based on results obtained in cohort 1.~Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
241188|NCT01425528|O1|Outcome|Cohort 1|"This cohort will be enrolled first. Analysis will be done to determine the optimum dosing of Kuvan to normalize BH4 levels in the Cerebral Spinal Fluid.~Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
241189|NCT01425528|E2|Reported Event|Cohort 2|"Participants in cohort 2 will be enrolled after the analysis of cohort 1 data has taken place. Dosing for cohort 2 will be based on results obtained in cohort 1.~Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
241190|NCT01425528|E1|Reported Event|Cohort 1|"This cohort will be enrolled first. Analysis will be done to determine the optimum dosing of Kuvan to normalize BH4 levels in the Cerebral Spinal Fluid.~Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
241191|NCT01425463|B3|Baseline|Total|Total of all reporting groups
241192|NCT01425463|B2|Baseline|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
241193|NCT01425463|B1|Baseline|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
241194|NCT01425463|P2|Participant Flow|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
241195|NCT01425463|P1|Participant Flow|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
241196|NCT01425463|O2|Outcome|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
241197|NCT01425463|O1|Outcome|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
241198|NCT01425463|O2|Outcome|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
241199|NCT01425463|O1|Outcome|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
241200|NCT01425463|O2|Outcome|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
241201|NCT01425463|O1|Outcome|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
241202|NCT01425463|O2|Outcome|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
241203|NCT01425463|O1|Outcome|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
241204|NCT01425463|O2|Outcome|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
241205|NCT01425463|O1|Outcome|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
241206|NCT01425463|E2|Reported Event|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
241207|NCT01425463|E1|Reported Event|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
241208|NCT01425359|B3|Baseline|Total|Total of all reporting groups
241209|NCT01425359|B2|Baseline|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
241210|NCT01425359|B1|Baseline|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
241356|NCT01424644|B2|Baseline|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
263766|NCT01348165|O6|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
241211|NCT01425359|P2|Participant Flow|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
241212|NCT01425359|P1|Participant Flow|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
241213|NCT01425359|O2|Outcome|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
241214|NCT01425359|O1|Outcome|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
241215|NCT01425359|O2|Outcome|Qualifying Phase: Participants Entered a 2-week Washout Period|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
241216|NCT01425359|O1|Outcome|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
241217|NCT01425359|O2|Outcome|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
241218|NCT01425359|O1|Outcome|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
241219|NCT01425359|O2|Outcome|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
241220|NCT01425359|O1|Outcome|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
241221|NCT01425359|O2|Outcome|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
241247|NCT01425268|O2|Outcome|Saline Tissue Expansion|"Saline Tissue Expansion inflated by needle injections of saline~Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline."
241357|NCT01424644|B1|Baseline|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
241222|NCT01425359|O1|Outcome|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
241223|NCT01425359|O2|Outcome|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
241224|NCT01425359|O1|Outcome|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
241225|NCT01425359|E2|Reported Event|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
241226|NCT01425359|E1|Reported Event|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
241227|NCT01425307|B3|Baseline|Total|Total of all reporting groups
241228|NCT01425307|B2|Baseline|Treatment Arm|"Hydroxyurea will be provided as capsules or liquid~Hydroxyurea: Capsules (300 mg, 400 mg, or 500 mg) taken once daily or liquid formulation (100 mg/mL)"
241229|NCT01425307|B1|Baseline|Standard Therapy|Standard Therapy of monthly transfusions
241230|NCT01425307|P2|Participant Flow|Treatment Arm|"Hydroxyurea will be provided as capsules or liquid~Hydroxyurea: Capsules (300 mg, 400 mg, or 500 mg) taken once daily or liquid formulation (100 mg/mL)"
241231|NCT01425307|P1|Participant Flow|Standard Therapy|Standard Therapy of monthly transfusions
241232|NCT01425307|O2|Outcome|Treatment Arm|Hydroxyurea will be provided as capsules and liquid
241233|NCT01425307|O1|Outcome|Standard Therapy|Standard Therapy of monthly transfusions
241234|NCT01425307|O2|Outcome|Treatment Arm|Hydroxyurea will be provided as capsules and liquid
241235|NCT01425307|O1|Outcome|Standard Therapy|Standard Therapy of monthly transfusions
241236|NCT01425307|O2|Outcome|Standard Therapy|Standard Therapy of monthly transfusions
241237|NCT01425307|O1|Outcome|Treatment Arm|"Hydroxyurea will be provided as capsules or liquid~Hydroxyurea: Capsules (300 mg, 400 mg, or 500 mg) taken once daily or liquid formulation (100 mg/mL)"
241238|NCT01425307|E2|Reported Event|Treatment Arm|"Hydroxyurea will be provided as capsules or liquid~Hydroxyurea: Capsules (300 mg, 400 mg, or 500 mg) taken once daily or liquid formulation (100 mg/mL)"
241239|NCT01425307|E1|Reported Event|Standard Therapy|Standard Therapy of monthly transfusions
241240|NCT01425268|B3|Baseline|Total|Total of all reporting groups
241241|NCT01425268|B2|Baseline|Saline Tissue Expansion|"Saline Tissue Expansion inflated by needle injections of saline~Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline."
241242|NCT01425268|B1|Baseline|AeroForm Tissue Expansion|"AeroForm Tissue Expansion inflation with carbon dioxide by remote control~AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander."
241243|NCT01425268|P2|Participant Flow|Saline Tissue Expansion|"Saline Tissue Expansion inflated by needle injections of saline~Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline."
241244|NCT01425268|P1|Participant Flow|AeroForm Tissue Expansion|"AeroForm Tissue Expansion inflation with carbon dioxide by remote control~AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander."
241245|NCT01425268|O2|Outcome|Saline Tissue Expansion|"Saline Tissue Expansion inflated by needle injections of saline~Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline."
241246|NCT01425268|O1|Outcome|AeroForm Tissue Expansion|"AeroForm Tissue Expansion inflation with carbon dioxide by remote control~AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander."
241632|NCT01424306|O3|Outcome|HFCS Arm - Day 9|Gene expression measured on day 9 of HFCS-sweetened beverage intervention period
263767|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
241248|NCT01425268|O1|Outcome|AeroForm Tissue Expansion|"AeroForm Tissue Expansion inflation with carbon dioxide by remote control~AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander."
241249|NCT01425268|E2|Reported Event|Saline Tissue Expansion|"Saline Tissue Expansion inflated by needle injections of saline~Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline."
241250|NCT01425268|E1|Reported Event|AeroForm Tissue Expansion|"AeroForm Tissue Expansion inflation with carbon dioxide by remote control~AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander."
241251|NCT01425229|B1|Baseline|Bosentan|Bosentan PK
241252|NCT01425229|P1|Participant Flow|Bosentan|Bosentan pharmacokinetics
241253|NCT01425229|O3|Outcome|Bosentan During Clarithromycin|administration of bosentan 125 mg p.o. b.i.d. on day 11-14 and administration of clarithromycin 500 mg p.o b.i.d. on day 11-14
241254|NCT01425229|O2|Outcome|Bosentan at Steady-state|administration of bosentan 125 mg p.o. b.i.d. on day 2-10
241255|NCT01425229|O1|Outcome|Bosentan After First Dose|administration of bosentan 125 mg p.o. single dose
241256|NCT01425229|O3|Outcome|Bosentan During Clarithromycin|administration of bosentan 125 mg p.o. b.i.d. on day 11-14 and administration of clarithromycin 500 mg p.o b.i.d. on day 11-14
241257|NCT01425229|O2|Outcome|Bosentan at Steady-state|administration of bosentan 125 mg p.o. b.i.d. on day 2-10
241258|NCT01425229|O1|Outcome|Bosentan After First Dose|administration of bosentan 125 mg p.o. single dose
241259|NCT01425229|E3|Reported Event|Bosentan During Clarithromycin|Bosentan PK during clarithromycin
241260|NCT01425229|E2|Reported Event|Bosentan at Steady-state|Bosentan PK at steady-state
241261|NCT01425229|E1|Reported Event|Bosentan After First Dose|Bosentan PK after first dose
241262|NCT01425203|B3|Baseline|Total|Total of all reporting groups
241263|NCT01425203|B2|Baseline|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
241264|NCT01425203|B1|Baseline|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
241265|NCT01425203|P3|Participant Flow|Crossover Arm|Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
241266|NCT01425203|P2|Participant Flow|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
241267|NCT01425203|P1|Participant Flow|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
241268|NCT01425203|O3|Outcome|Crossover Arm|Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
241269|NCT01425203|O2|Outcome|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
241270|NCT01425203|O1|Outcome|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
241271|NCT01425203|O3|Outcome|Crossover Arm|Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
241272|NCT01425203|O2|Outcome|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
241273|NCT01425203|O1|Outcome|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
241274|NCT01425203|O3|Outcome|Crossover Arm|Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
241275|NCT01425203|O2|Outcome|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
241276|NCT01425203|O1|Outcome|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
241277|NCT01425203|E3|Reported Event|Crossover Arm|Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
241278|NCT01425203|E2|Reported Event|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
241279|NCT01425203|E1|Reported Event|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
241280|NCT01425190|B4|Baseline|Total|Total of all reporting groups
241323|NCT01424930|P1|Participant Flow|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
241281|NCT01425190|B3|Baseline|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
241282|NCT01425190|B2|Baseline|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
241283|NCT01425190|B1|Baseline|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
241284|NCT01425190|P3|Participant Flow|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
241285|NCT01425190|P2|Participant Flow|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
241286|NCT01425190|P1|Participant Flow|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
241287|NCT01425190|O3|Outcome|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
241288|NCT01425190|O2|Outcome|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
241289|NCT01425190|O1|Outcome|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
241290|NCT01425190|O3|Outcome|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
241291|NCT01425190|O2|Outcome|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
241292|NCT01425190|O1|Outcome|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
241293|NCT01425190|O3|Outcome|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
241294|NCT01425190|O2|Outcome|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
241295|NCT01425190|O1|Outcome|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
241296|NCT01425190|O3|Outcome|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
241354|NCT01424813|E1|Reported Event|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
241297|NCT01425190|O2|Outcome|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
241298|NCT01425190|O1|Outcome|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
241299|NCT01425190|E3|Reported Event|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
241300|NCT01425190|E2|Reported Event|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
241301|NCT01425190|E1|Reported Event|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
241302|NCT01424943|B3|Baseline|Total|Total of all reporting groups
241303|NCT01424943|B2|Baseline|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
241304|NCT01424943|B1|Baseline|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
241305|NCT01424943|P2|Participant Flow|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
241306|NCT01424943|P1|Participant Flow|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
241307|NCT01424943|O2|Outcome|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
241308|NCT01424943|O1|Outcome|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
241309|NCT01424943|O2|Outcome|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
241310|NCT01424943|O1|Outcome|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
241311|NCT01424943|O2|Outcome|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
241312|NCT01424943|O1|Outcome|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
241313|NCT01424943|O2|Outcome|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
241314|NCT01424943|O1|Outcome|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
241315|NCT01424943|O2|Outcome|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
241316|NCT01424943|O1|Outcome|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
241317|NCT01424943|E2|Reported Event|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
241318|NCT01424943|E1|Reported Event|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
241319|NCT01424930|B3|Baseline|Total|Total of all reporting groups
241320|NCT01424930|B2|Baseline|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
241321|NCT01424930|B1|Baseline|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
241322|NCT01424930|P2|Participant Flow|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
241355|NCT01424644|B3|Baseline|Total|Total of all reporting groups
241324|NCT01424930|O2|Outcome|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
241325|NCT01424930|O1|Outcome|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
241326|NCT01424930|O2|Outcome|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
241327|NCT01424930|O1|Outcome|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
241328|NCT01424930|O2|Outcome|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
241329|NCT01424930|O1|Outcome|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
241330|NCT01424930|O2|Outcome|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
241331|NCT01424930|O1|Outcome|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
241332|NCT01424930|E2|Reported Event|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
241333|NCT01424930|E1|Reported Event|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
241334|NCT01424813|B3|Baseline|Total|Total of all reporting groups
241335|NCT01424813|B2|Baseline|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
241336|NCT01424813|B1|Baseline|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
241337|NCT01424813|P2|Participant Flow|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
241338|NCT01424813|P1|Participant Flow|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
241339|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
241340|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
241341|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
241342|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
241343|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
241344|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
241345|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
241346|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
241347|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
241348|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
241349|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
241350|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
241351|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
241352|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
241353|NCT01424813|E2|Reported Event|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
241633|NCT01424306|O2|Outcome|Glucose Arm - Day 9|Gene expression measured on day 9 of glucose-sweetened beverage intervention period
241358|NCT01424644|P2|Participant Flow|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
241359|NCT01424644|P1|Participant Flow|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
241360|NCT01424644|O2|Outcome|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
241361|NCT01424644|O1|Outcome|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
241362|NCT01424644|O2|Outcome|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
241363|NCT01424644|O1|Outcome|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
241364|NCT01424644|O2|Outcome|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
241365|NCT01424644|O1|Outcome|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
241366|NCT01424644|O2|Outcome|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
241367|NCT01424644|O1|Outcome|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
241368|NCT01424644|O2|Outcome|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
241369|NCT01424644|O1|Outcome|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
241370|NCT01424644|E2|Reported Event|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
241371|NCT01424644|E1|Reported Event|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
241372|NCT01424566|B1|Baseline|Single-blind Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 2 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
241373|NCT01424566|P3|Participant Flow|Double-blind Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
241374|NCT01424566|P2|Participant Flow|Double-blind Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in Numerical Rating Scale (NRS) pain scores during the single-blind treatment period (Part A).
241375|NCT01424566|P1|Participant Flow|Single-blind Nabiximols|Nabiximols was self-administered by participants as a 100 microliter (μL) oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 2 weeks. Nabiximols oromucosal spray contained delta-9-tetrahydrocannabinol (THC) (27 milligrams [mg]/milliliter [mL]):cannabidiol (CBD) (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
241376|NCT01424566|O2|Outcome|Double-blind Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
241377|NCT01424566|O1|Outcome|Double-blind Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
241418|NCT01424514|O1|Outcome|SB-705498 12 mg|Participants received repeat doses of intranasal spray of SB-705498 12 mg as an active intervention once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241378|NCT01424566|O2|Outcome|Double-blind Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
241379|NCT01424566|O1|Outcome|Double-blind Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
241380|NCT01424566|O2|Outcome|Double-blind Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
241381|NCT01424566|O1|Outcome|Double-blind Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
241382|NCT01424566|O2|Outcome|Double-blind Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
241383|NCT01424566|O1|Outcome|Double-blind Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
241384|NCT01424566|O2|Outcome|Double-blind Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
241385|NCT01424566|O1|Outcome|Double-blind Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
241386|NCT01424566|O2|Outcome|Double-blind Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
241387|NCT01424566|O1|Outcome|Double-blind Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
241388|NCT01424566|O2|Outcome|Double-blind Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
241389|NCT01424566|O1|Outcome|Double-blind Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
241390|NCT01424566|O2|Outcome|Double-blind Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
241391|NCT01424566|O1|Outcome|Double-blind Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
241392|NCT01424566|O2|Outcome|Double-blind Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
241393|NCT01424566|O1|Outcome|Double-blind Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
241394|NCT01424566|O2|Outcome|Double-blind Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
241395|NCT01424566|O1|Outcome|Double-blind Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
241396|NCT01424566|O2|Outcome|Double-blind Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
241397|NCT01424566|O1|Outcome|Double-blind Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
241398|NCT01424566|E3|Reported Event|Double-blind Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
241419|NCT01424514|O2|Outcome|SB-705498 12 mg|Participants received repeat doses of intranasal spray of SB-705498 12 mg as an active intervention once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241420|NCT01424514|O1|Outcome|Placebo|Participants received repeat doses of matching placebo once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241399|NCT01424566|E2|Reported Event|Double-blind Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening for 5 weeks, at the same level of dosing attained during the last 4 days of the single-blind period; however, the number of sprays could be decreased based upon tolerability throughout the study. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD. To enter the double-blind treatment period (Part B), participants had to achieve at least a 15% improvement in NRS pain scores during the single-blind treatment period (Part A).
241400|NCT01424566|E1|Reported Event|Single-blind Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 2 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD. Two participants did not receive study drug and are not included in the safety set.
241401|NCT01424514|B1|Baseline|All Treatments Combined|The study consisted of 2 treatment periods, each of 14 days (2 weeks). The treatment periods were separated by at least 4 weeks of washout period. Participants were administered intranasal spray of SB-705498 12 milligram (mg) or matching placebo as repeat doses for 14 days once daily in treatment period 1 (TP1), and the converse treatments in TP2 two treatment sequences (active/placebo [A/P] or placebo/active [P/A]) with respect to the randomization.
241402|NCT01424514|P2|Participant Flow|Placebo Then Active|Participants received repeat doses of matching placebo once daily for 14 days during intervention period 1 according to a plan of randomization. After a washout period of 4 weeks, participants then received repeat doses of intranasal spray of SB-705498 12 mg as an active intervention once daily for 14 days during intervention
241403|NCT01424514|P1|Participant Flow|Active Then Placebo|Participants received repeat doses of intranasal spray of SB-705498 12 milligram (mg) as an active intervention once daily for 14 days during intervention period 1 according to a plan of randomization. After a washout period of 4 weeks, participants then received repeat doses of matching placebo once daily for 14 days during intervention period 2.
241404|NCT01424514|O2|Outcome|SB-705498 12 mg|Participants received repeat doses of intranasal spray of SB-705498 12 milligram (mg) as an active intervention once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241405|NCT01424514|O1|Outcome|Placebo|Participants received repeat doses of matching placebo once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241406|NCT01424514|O2|Outcome|SB-705498 12 mg|Participants received repeat doses of intranasal spray of SB-705498 12 milligram (mg) as an active intervention once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241407|NCT01424514|O1|Outcome|Placebo|Participants received repeat doses of matching placebo once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241408|NCT01424514|O2|Outcome|SB-705498 12 mg|Participants received repeat doses of intranasal spray of SB-705498 12 milligram (mg) as an active intervention once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241409|NCT01424514|O1|Outcome|Placebo|Participants received repeat doses of matching placebo once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241410|NCT01424514|O2|Outcome|SB-705498 12 mg|Participants received repeat doses of intranasal spray of SB-705498 12 milligram (mg) as an active intervention once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241411|NCT01424514|O1|Outcome|Placebo|Participants received repeat doses of matching placebo once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241412|NCT01424514|O2|Outcome|SB-705498 12 mg|Participants received repeat doses of intranasal spray of SB-705498 12 milligram (mg) as an active intervention once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241413|NCT01424514|O1|Outcome|Placebo|Participants received repeat doses of matching placebo once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241414|NCT01424514|O2|Outcome|SB-705498 12 mg|Participants received repeat doses of intranasal spray of SB-705498 12 milligram (mg) as an active intervention once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241415|NCT01424514|O1|Outcome|Placebo|Participants received repeat doses of matching placebo once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241416|NCT01424514|O1|Outcome|SB-705498 12 mg|Participants received repeat doses of intranasal spray of SB-705498 12 mg as an active intervention once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241417|NCT01424514|O1|Outcome|SB-705498 12 mg|Participants received repeat doses of intranasal spray of SB-705498 12 mg as an active intervention once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241626|NCT01424306|O3|Outcome|HFCS Arm - Day 9|Gene expression measured on day 9 of HFCS-sweetened beverage intervention period
241421|NCT01424514|O2|Outcome|SB-705498 12 mg|Participants received repeat doses of intranasal spray of SB-705498 12 mg as an active intervention once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241422|NCT01424514|O1|Outcome|Placebo|Participants received repeat doses of matching placebo once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241423|NCT01424514|O2|Outcome|SB-705498 12 mg|Eligible participants received intranasal spray of SB-705498 12 mg once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241424|NCT01424514|O1|Outcome|Placebo|Eligible participants received matching placebo to SB-705498 12 mg once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active)separated by at least 4 weeks of washout period.
241425|NCT01424514|O2|Outcome|SB-705498 12 mg|Eligible participants received intranasal spray of SB-705498 12 mg once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241426|NCT01424514|O1|Outcome|Placebo|Eligible participants received matching placebo to SB-705498 12 mg once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241427|NCT01424514|O2|Outcome|SB-705498 12 mg|Eligible participants received intranasal spray of SB-705498 12 mg once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241428|NCT01424514|O1|Outcome|Placebo|Eligible participants received matching placebo to SB-705498 12 mg once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241429|NCT01424514|O2|Outcome|SB-705498 12 mg|Eligible participants received intranasal spray of SB-705498 12 mg once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241430|NCT01424514|O1|Outcome|Placebo|Eligible participants received matching placebo to SB-705498 12 mg once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241431|NCT01424514|O2|Outcome|SB-705498 12 mg|Eligible participants received intranasal spray of SB-705498 12 mg once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241432|NCT01424514|O1|Outcome|Placebo|Eligible participants received matching placebo to SB-705498 12 mg once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241433|NCT01424514|O2|Outcome|SB-705498 12 mg|Eligible participants received intranasal spray of SB-705498 12 mg once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241434|NCT01424514|O1|Outcome|Placebo|Eligible participants received matching placebo to SB-705498 12 mg once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241435|NCT01424514|O2|Outcome|SB-705498 12 mg|Eligible participants received intranasal spray of SB-705498 12 mg once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241436|NCT01424514|O1|Outcome|Placebo|Eligible participants received matching placebo to SB-705498 12 mg once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241437|NCT01424514|O2|Outcome|SB-705498 12 mg|Eligible participants received intranasal spray of SB-705498 12 mg once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241438|NCT01424514|O1|Outcome|Placebo|Eligible participants received matching placebo to SB-705498 12 mg once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241439|NCT01424514|E2|Reported Event|SB-705498 12 mg|Participants received repeat doses of intranasal spray of SB-705498 12 milligram (mg) as an active intervention once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241440|NCT01424514|E1|Reported Event|Placebo|Participants received repeat doses of matching placebo once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.
241441|NCT01424501|B7|Baseline|Total|Total of all reporting groups
241442|NCT01424501|B6|Baseline|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241443|NCT01424501|B5|Baseline|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241444|NCT01424501|B4|Baseline|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241445|NCT01424501|B3|Baseline|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241446|NCT01424501|B2|Baseline|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241447|NCT01424501|B1|Baseline|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241448|NCT01424501|P6|Participant Flow|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241449|NCT01424501|P5|Participant Flow|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241450|NCT01424501|P4|Participant Flow|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241451|NCT01424501|P3|Participant Flow|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241452|NCT01424501|P2|Participant Flow|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241453|NCT01424501|P1|Participant Flow|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241454|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241455|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241456|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241457|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241458|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241459|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241460|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241461|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241462|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241463|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241464|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241465|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241466|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241467|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241468|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241469|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241470|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241471|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241472|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241473|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241474|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
263768|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
241475|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241476|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241477|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241478|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241479|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241480|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241481|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241482|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241483|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241484|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241485|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241486|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241487|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241488|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241489|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241490|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241491|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241492|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241493|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241494|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241495|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241496|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241497|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241498|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241499|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241500|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241501|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241502|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241503|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241504|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241627|NCT01424306|O2|Outcome|Glucose Arm - Day 9|Gene expression measured on day 9 of glucose-sweetened beverage intervention period
241505|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241506|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241507|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241508|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241509|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241510|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241511|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241512|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241513|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241514|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241515|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241516|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241517|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241518|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241519|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241520|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241521|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241522|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241523|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241524|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241525|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241526|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241527|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241528|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241529|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241530|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241531|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241532|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241533|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241534|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241628|NCT01424306|O1|Outcome|Fructose Arm - Day 9|Gene expression measured on day 9 of fructose-sweetened beverage intervention period
241535|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241536|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241537|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241538|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241539|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241540|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241541|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241542|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241543|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241544|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241545|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241546|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241547|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241548|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241549|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241550|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241551|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241552|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241553|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241554|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241555|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241556|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241557|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241558|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241559|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241560|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241561|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241562|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241563|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241564|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241629|NCT01424306|O3|Outcome|HFCS Arm - Day 9|Gene expression measured on day 9 of HFCS-sweetened beverage intervention period
241565|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241566|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241567|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241568|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241569|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241570|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241571|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241572|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241573|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241574|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241575|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241576|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241577|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241578|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241579|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241580|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241581|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241582|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241583|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241584|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241585|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241586|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241587|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241588|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241589|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241590|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241591|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241592|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241593|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241594|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241630|NCT01424306|O2|Outcome|Glucose Arm - Day 9|Gene expression measured on day 9 of glucose-sweetened beverage intervention period
241595|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241596|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241597|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1
241598|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241599|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241600|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241601|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241602|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241603|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241604|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241605|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241606|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241607|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241608|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241609|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241610|NCT01424501|E6|Reported Event|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241611|NCT01424501|E5|Reported Event|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241612|NCT01424501|E4|Reported Event|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241613|NCT01424501|E3|Reported Event|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241614|NCT01424501|E2|Reported Event|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
241615|NCT01424501|E1|Reported Event|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
241616|NCT01424306|B1|Baseline|Study Subjects|All six treatment orders combined
241617|NCT01424306|P6|Participant Flow|Glucose - HFCS - Fructose|"Subjects treated in the order glucose-sweetened beverage - wash out - HFCS-sweetened beverage- wash out - fructose-sweetened beverage~Treatments each lasted 8 days and were separated by a 20-day washout."
241618|NCT01424306|P5|Participant Flow|Glucose - Fructose - HFCS|"Subjects treated in the order glucose-sweetened beverage - wash out - fructose-sweetened beverage- wash out - HFCS-sweetened beverage~Treatments each lasted 8 days and were separated by a 20-day washout."
241619|NCT01424306|P4|Participant Flow|HFCS - Glucose - Fructose|"Subjects treated in the order HFCS-sweetened beverage - wash out - glucose-sweetened beverage- wash out - fructose-sweetened beverage~Treatments each lasted 8 days and were separated by a 20-day washout."
241620|NCT01424306|P3|Participant Flow|HFCS - Fructose - Glucose|"Subjects treated in the order HFCS-sweetened beverage - wash out - fructose-sweetened beverage- wash out - glucose-sweetened beverage~Treatments each lasted 8 days and were separated by a 20-day washout."
241621|NCT01424306|P2|Participant Flow|Fructose - HFCS - Glucose|"Subjects treated in the order fructose-sweetened beverage - wash out - HFCS-sweetened beverage- wash out - glucose-sweetened beverage~Treatments each lasted 8 days and were separated by a 20-day washout."
241622|NCT01424306|P1|Participant Flow|Fructose - Glucose - HFCS|"Subjects treated in the order fructose-sweetened beverage - wash out - glucose-sweetened beverage- wash out - HFCS-sweetened beverage~Treatments each lasted 8 days and were separated by a 20-day washout."
241623|NCT01424306|O3|Outcome|HFCS Arm - Day 9|Gene expression measured on day 9 of HFCS-sweetened beverage intervention period
241624|NCT01424306|O2|Outcome|Glucose Arm - Day 9|Gene expression measured on day 9 of glucose-sweetened beverage intervention period
241625|NCT01424306|O1|Outcome|Fructose Arm - Day 9|Gene expression measured on day 9 of fructose-sweetened beverage intervention period
241634|NCT01424306|O1|Outcome|Fructose Arm - Day 9|Gene expression measured on day 9 of fructose-sweetened beverage intervention period
241635|NCT01424306|O3|Outcome|HFCS Arm - Day 9|Gene expression measured on day 9 of HFCS-sweetened beverage intervention period
241636|NCT01424306|O2|Outcome|Glucose Arm - Day 9|Gene expression measured on day 9 of glucose-sweetened beverage intervention period
241637|NCT01424306|O1|Outcome|Fructose Arm - Day 9|Gene expression measured on day 9 of fructose-sweetened beverage intervention period
241638|NCT01424306|O3|Outcome|HFCS Arm - Day 9|Gene expression measured on day 9 of HFCS-sweetened beverage intervention period
241639|NCT01424306|O2|Outcome|Glucose Arm - Day 9|Gene expression measured on day 9 of glucose-sweetened beverage intervention period
241640|NCT01424306|O1|Outcome|Fructose Arm - Day 9|Gene expression measured on day 9 of fructose-sweetened beverage intervention period
241641|NCT01424306|O3|Outcome|HFCS Arm - Day 9|LBP measured on day 9 of HFCS-sweetened beverage intervention period
241642|NCT01424306|O2|Outcome|Glucose Arm - Day 9|LBP measured on day 9 of glucose-sweetened beverage intervention period
241643|NCT01424306|O1|Outcome|Fructose Arm - Day 9|LBP measured on day 9 of fructose-sweetened beverage intervention period
241644|NCT01424306|O3|Outcome|HFCS Arm - Day 9|Zonulin measured on day 9 of HFCS-sweetened beverage intervention period
241645|NCT01424306|O2|Outcome|Glucose Arm - Day 9|Zonulin measured on day 9 of glucose-sweetened beverage intervention period
241646|NCT01424306|O1|Outcome|Fructose Arm - Day 9|Zonulin measured on day 9 of fructose-sweetened beverage intervention period
241647|NCT01424306|O3|Outcome|HFCS Arm - Day 9|Lactulose:Mannitol ratio measured on day 9 of HFCS-sweetened beverage intervention period
241648|NCT01424306|O2|Outcome|Glucose Arm - Day 9|Lactulose:Mannitol ratio measured on day 9 of glucose-sweetened beverage intervention period
241649|NCT01424306|O1|Outcome|Fructose Arm - Day 9|Lactulose:Mannitol ratio measured on day 9 of fructose-sweetened beverage intervention period
241650|NCT01424306|O3|Outcome|HFCS Arm|Average total energy consumed each day during the HFCS-sweetened beverage intervention period
241651|NCT01424306|O2|Outcome|Glucose Arm|Average total energy consumed each day during the glucose-sweetened beverage intervention period
241652|NCT01424306|O1|Outcome|Fructose Arm|Average total energy consumed each day during the fructose-sweetened beverage intervention period
241653|NCT01424306|O3|Outcome|HFCS Arm - Day 9|Adiponectin measured on day 9 of HFCS-sweetened beverage intervention period
241654|NCT01424306|O2|Outcome|Glucose Arm - Day 9|Adiponectin measured on day 9 of glucose-sweetened beverage intervention period
241655|NCT01424306|O1|Outcome|Fructose Arm - Day 9|Adiponectin measured on day 9 of fructose-sweetened beverage intervention period
241656|NCT01424306|O3|Outcome|HFCS Arm - Day 9|IL-6 measured on day 9 of HFCS-sweetened beverage intervention period
241657|NCT01424306|O2|Outcome|Glucose Arm - Day 9|IL-6 measured on day 9 of glucose-sweetened beverage intervention period
241658|NCT01424306|O1|Outcome|Fructose Arm - Day 9|IL-6 measured on day 9 of fructose-sweetened beverage intervention period
241659|NCT01424306|O6|Outcome|HFCS Arm - Day 9|CRP measured on day 9 of HFCS-sweetened beverage intervention period
241660|NCT01424306|O5|Outcome|HFCS Arm - Day 1|CRP measured on day 1 of HFCS-sweetened beverage intervention period
241661|NCT01424306|O4|Outcome|Glucose Arm - Day 9|CRP measured on day 9 of glucose-sweetened beverage intervention period
241662|NCT01424306|O3|Outcome|Glucose Arm - Day 1|CRP measured on day 1 of glucose-sweetened beverage intervention period
241663|NCT01424306|O2|Outcome|Fructose Arm - Day 9|CRP measured on day 9 of fructose-sweetened beverage intervention period
241664|NCT01424306|O1|Outcome|Fructose Arm - Day 1|CRP measured on day 1 of fructose-sweetened beverage intervention period
241665|NCT01424306|E3|Reported Event|HFCS Arm|HFCS liquid mixed with powdered drink flavoring (Lemon) and aspartame to match sweetness
241666|NCT01424306|E2|Reported Event|Glucose Arm|Powdered dextrose mixed with powdered drink flavoring (Lemon) and aspartame to match sweetness
241667|NCT01424306|E1|Reported Event|Fructose Arm|Powdered fructose mixed with powdered drink flavoring (Lemon)
241668|NCT01424228|B3|Baseline|Total|Total of all reporting groups
241669|NCT01424228|B2|Baseline|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
241670|NCT01424228|B1|Baseline|Placebo|Tablet once daily before breakfast
241671|NCT01424228|P2|Participant Flow|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
241672|NCT01424228|P1|Participant Flow|Placebo|Tablet once daily before breakfast
241673|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
241674|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
241675|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
241676|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
241677|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
241678|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
241679|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
241680|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
241681|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
241682|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
241683|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
241684|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
241685|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
241686|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
241687|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
241688|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
241689|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
241690|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
241691|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
241692|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
241693|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
241694|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
241695|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
241696|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
241697|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
241698|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
241699|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
241700|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
241701|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
241702|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
241703|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
241704|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
241705|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
241706|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
241707|NCT01424228|E2|Reported Event|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
241708|NCT01424228|E1|Reported Event|Placebo|Tablet once daily before breakfast
241709|NCT01424189|B3|Baseline|Total|Total of all reporting groups
241710|NCT01424189|B2|Baseline|ReSTOR IOL|AcrySof® ReSTOR® Multifocal IOL Model SA60D3, bilateral implantation
241711|NCT01424189|B1|Baseline|ReSTOR Toric IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
241712|NCT01424189|P2|Participant Flow|ReSTOR IOL|AcrySof® ReSTOR® Multifocal IOL Model SA60D3, bilateral implantation
241713|NCT01424189|P1|Participant Flow|ReSTOR Toric IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
241714|NCT01424189|O2|Outcome|ReSTOR IOL|AcrySof® ReSTOR® Multifocal IOL Model SA60D3
241715|NCT01424189|O1|Outcome|ReSTOR Toric IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
241716|NCT01424189|O2|Outcome|ReSTOR IOL|AcrySof® ReSTOR® Multifocal IOL Model SA60D3
241717|NCT01424189|O1|Outcome|ReSTOR Toric IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
241718|NCT01424189|O2|Outcome|ReSTOR IOL|AcrySof® ReSTOR® Multifocal IOL Model SA60D3
241719|NCT01424189|O1|Outcome|ReSTOR Toric IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
241720|NCT01424189|O2|Outcome|ReSTOR IOL|AcrySof® ReSTOR® Multifocal IOL Model SA60D3
241721|NCT01424189|O1|Outcome|ReSTOR Toric IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
241722|NCT01424189|E2|Reported Event|ReSTOR IOL|AcrySof® ReSTOR® Multifocal IOL Model SA60D3
241723|NCT01424189|E1|Reported Event|ReSTOR Toric IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
241724|NCT01424072|B4|Baseline|Total|Total of all reporting groups
241725|NCT01424072|B3|Baseline|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
241726|NCT01424072|B2|Baseline|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.~auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
241727|NCT01424072|B1|Baseline|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.~auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
241728|NCT01424072|P3|Participant Flow|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
241729|NCT01424072|P2|Participant Flow|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.~auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
241730|NCT01424072|P1|Participant Flow|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.~auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
241731|NCT01424072|O3|Outcome|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
241732|NCT01424072|O2|Outcome|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.~auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
241733|NCT01424072|O1|Outcome|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.~auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
241734|NCT01424072|O3|Outcome|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
241735|NCT01424072|O2|Outcome|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.~auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
241736|NCT01424072|O1|Outcome|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.~auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
241737|NCT01424072|O3|Outcome|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
241738|NCT01424072|O2|Outcome|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.~auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
241739|NCT01424072|O1|Outcome|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.~auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
241740|NCT01424072|O3|Outcome|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
241741|NCT01424072|O2|Outcome|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.~auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
241742|NCT01424072|O1|Outcome|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.~auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
241743|NCT01424072|E3|Reported Event|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
241744|NCT01424072|E2|Reported Event|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.~auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
241745|NCT01424072|E1|Reported Event|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.~auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
241746|NCT01424033|B1|Baseline|N-Acetylcysteine|"This is an open label trial, all patient will be entered into one treatment arm.~N-Acetylcysteine: 600mg by mouth, three times daily for 12 months"
241747|NCT01424033|P1|Participant Flow|N-Acetylcysteine|"This is an open label trial, all patient will be entered into one treatment arm.~N-Acetylcysteine: 600mg by mouth, three times daily for 12 months"
241748|NCT01424033|O1|Outcome|N-Acetylcysteine|"This is an open label trial, all patient will be entered into one treatment arm.~N-Acetylcysteine: 600mg by mouth, three times daily for 12 months"
241749|NCT01424033|E1|Reported Event|N-Acetylcysteine|"This is an open label trial, all patient will be entered into one treatment arm.~N-Acetylcysteine: 600mg by mouth, three times daily for 12 months"
241750|NCT01423916|B4|Baseline|Total|Total of all reporting groups
241751|NCT01423916|B3|Baseline|Moxifloxacin/Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
241752|NCT01423916|B2|Baseline|Brexpiprzole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241753|NCT01423916|B1|Baseline|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241754|NCT01423916|P3|Participant Flow|Moxifloxacin/Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
241755|NCT01423916|P2|Participant Flow|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241756|NCT01423916|P1|Participant Flow|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD (once daily) on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241757|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
241758|NCT01423916|O3|Outcome|Moxifloxacin|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
241759|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants were randomised to 1 of 4 arms in a ratio of 2:2:1:1. On Day 1, all participants received brexpiprazole placebo tablets. Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241760|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants were randomised to 1 of 4 arms in a ratio of 2:2:1:1. On Day 1, all participants received brexpiprazole placebo tablets. Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241923|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
241761|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
241762|NCT01423916|O3|Outcome|Moxifloxacin 400mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
241763|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241764|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241765|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
241766|NCT01423916|O3|Outcome|Moxifloxacin 400mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
241767|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241768|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241769|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
241770|NCT01423916|O3|Outcome|Moxifloxacin 400mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
241771|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241772|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241773|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
241774|NCT01423916|O3|Outcome|Moxifloxacin 400mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
241775|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241776|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241777|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
241778|NCT01423916|O3|Outcome|Moxifloaxcin 400mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
241779|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241780|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241781|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
241782|NCT01423916|O3|Outcome|Moxifloxacin 400mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
241783|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241784|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241785|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
241786|NCT01423916|O3|Outcome|Moxifloxacin 400 mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
241787|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241788|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241789|NCT01423916|O3|Outcome|Moxifloxacin/ Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
241790|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241791|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241792|NCT01423916|O3|Outcome|Moxifloxacin/ Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
241793|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241794|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241795|NCT01423916|O3|Outcome|Moxifloxacin/ Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
241796|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241797|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241798|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
241799|NCT01423916|O3|Outcome|Moxifloxacin|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
241800|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241801|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241802|NCT01423916|O3|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241803|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241804|NCT01423916|O1|Outcome|Moxifloxacin/Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
241805|NCT01423916|E4|Reported Event|Placebo|Placebo arm comprised of all participants who received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
241806|NCT01423916|E3|Reported Event|Moxifloxacin|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
241807|NCT01423916|E2|Reported Event|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241808|NCT01423916|E1|Reported Event|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
241809|NCT01423812|B3|Baseline|Total|Total of all reporting groups
241810|NCT01423812|B2|Baseline|Twice-daily Darunavir/Ritonavir|"Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily~Twice-daily Darunavir/ritonavir: Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily"
241811|NCT01423812|B1|Baseline|Once-daily Darunavir/Ritonavir|"Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily to Darunavir 800mg plus Ritonavir 100mg once-daily~Once-daily Darunavir/ritonavir: Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily at baseline to Darunavir 800mg plus Ritonavir 100mg once-daily for 48 weeks"
241812|NCT01423812|P2|Participant Flow|Twice-daily Darunavir/Ritonavir|"Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily~Twice-daily Darunavir/ritonavir: Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily"
241813|NCT01423812|P1|Participant Flow|Once-daily Darunavir/Ritonavir|"Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily to Darunavir 800mg plus Ritonavir 100mg once-daily~Once-daily Darunavir/ritonavir: Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily at baseline to Darunavir 800mg plus Ritonavir 100mg once-daily for 48 weeks"
241814|NCT01423812|O2|Outcome|Twice-daily Darunavir and Ritonavir|"Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily~Twice-daily Darunavir and ritonavir: Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily"
241815|NCT01423812|O1|Outcome|Once-daily Darunavir and Ritonavir|"Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily to Darunavir 800mg plus Ritonavir 100mg once-daily~Once-daily Darunavir and ritonavir: Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily at baseline to Darunavir 800mg plus Ritonavir 100mg once-daily for 48 weeks"
241816|NCT01423812|O2|Outcome|Twice-daily Darunavir/Ritonavir|"Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily~Twice-daily Darunavir/ritonavir: Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily"
241817|NCT01423812|O1|Outcome|Once-daily Darunavir/Ritonavir|"Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily to Darunavir 800mg plus Ritonavir 100mg once-daily~Once-daily Darunavir/ritonavir: Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily at baseline to Darunavir 800mg plus Ritonavir 100mg once-daily for 48 weeks"
241818|NCT01423812|E2|Reported Event|Twice-daily Darunavir/Ritonavir|"Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily~Twice-daily Darunavir/ritonavir: Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily"
241819|NCT01423812|E1|Reported Event|Once-daily Darunavir/Ritonavir|"Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily to Darunavir 800mg plus Ritonavir 100mg once-daily~Once-daily Darunavir/ritonavir: Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily at baseline to Darunavir 800mg plus Ritonavir 100mg once-daily for 48 weeks"
241820|NCT01423773|B1|Baseline|Overall|Each product worn bilaterally for two consecutive days in either Period One or Period Two. A wash-out of 24 hours minimum to 3 weeks maximum separated the two periods.
241821|NCT01423773|P2|Participant Flow|Lotrafilcon A Control, Then Lotrafilcon A Test|Lotrafilcon A control contact lenses worn in Period One, with lotrafilcon A test contact lenses worn in Period Two. Each product was worn bilaterally for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2. A wash-out of 24 hours minimum to 3 weeks maximum separated the two periods.
241822|NCT01423773|P1|Participant Flow|Lotrafilcon A Test, Then Lotrafilcon A Control|Lotrafilcon A test contact lenses worn in Period One, with lotrafilcon A control contact lenses worn in Period Two. Each product was worn bilaterally for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2. A wash-out of 24 hours minimum to 3 weeks maximum separated the two periods.
241823|NCT01423773|O2|Outcome|Lotrafilcon A Control|Lotrafilcon A control contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2.
241824|NCT01423773|O1|Outcome|Lotrafilcon A Test|Lotrafilcon A test contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2.
241825|NCT01423773|E2|Reported Event|Lotrafilcon A Control|Lotrafilcon A control contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2.
241826|NCT01423773|E1|Reported Event|Lotrafilcon A Test|Lotrafilcon A test contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2.
241827|NCT01423760|B3|Baseline|Total|Total of all reporting groups
241828|NCT01423760|B2|Baseline|Multiple Myeloma|"Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.~Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide."
241829|NCT01423760|B1|Baseline|Non-small Cell Lung Cancer (NSCLC)|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals. Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide.
241830|NCT01423760|P2|Participant Flow|Multiple Myeloma|"Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.~Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide."
241831|NCT01423760|P1|Participant Flow|Non-small Cell Lung Cancer (NSCLC)|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals. Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide.
241832|NCT01423760|O2|Outcome|Multiple Myeloma|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
241833|NCT01423760|O1|Outcome|Non-small Cell Lung Cancer (NSCLC)|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
241834|NCT01423760|O2|Outcome|Multiple Myeloma|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
241835|NCT01423760|O1|Outcome|Non-small Cell Lung Cancer (NSCLC)|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
241836|NCT01423760|E2|Reported Event|Multiple Myeloma|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
241924|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
263769|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
241837|NCT01423760|E1|Reported Event|NSCLC|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
241838|NCT01423617|B3|Baseline|Total|Total of all reporting groups
241839|NCT01423617|B2|Baseline|Placebo|Placebo: 3 tablets 2 times daily
241840|NCT01423617|B1|Baseline|Zenoctil|Zenoctil: 3 tablets 2 times daily
241841|NCT01423617|P2|Participant Flow|Placebo|Placebo: 3 tablets 2 times daily
241842|NCT01423617|P1|Participant Flow|Zenoctil|Zenoctil: 3 tablets 2 times daily
241843|NCT01423617|O2|Outcome|Placebo|Placebo: 3 tablets 2 times daily
241844|NCT01423617|O1|Outcome|Zenoctil|Zenoctil: 3 tablets 2 times daily
241845|NCT01423617|O2|Outcome|Placebo|Placebo: 3 tablets 2 times daily
241846|NCT01423617|O1|Outcome|Zenoctil|Zenoctil: 3 tablets 2 times daily
241847|NCT01423617|O2|Outcome|Placebo|Placebo: 3 tablets 2 times daily
241848|NCT01423617|O1|Outcome|Zenoctil|Zenoctil: 3 tablets 2 times daily
241849|NCT01423617|O2|Outcome|Placebo|Placebo: 3 tablets 2 times daily
241850|NCT01423617|O1|Outcome|Zenoctil|Zenoctil: 3 tablets 2 times daily
241851|NCT01423617|O2|Outcome|Placebo|Placebo: 3 tablets 2 times daily
241852|NCT01423617|O1|Outcome|Zenoctil|Zenoctil: 3 tablets 2 times daily
241853|NCT01423617|E2|Reported Event|Placebo|Placebo: 3 tablets 2 times daily
241854|NCT01423617|E1|Reported Event|Zenoctil|Zenoctil: 3 tablets 2 times daily
241855|NCT01423604|B4|Baseline|Total|Total of all reporting groups
241856|NCT01423604|B3|Baseline|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
241857|NCT01423604|B2|Baseline|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
241858|NCT01423604|B1|Baseline|Ruxolitinib - Safety Run-In|Subjects received capecitabine 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]) + ruxolitinib at 15 mg BID.
241859|NCT01423604|P2|Participant Flow|Placebo|Part 2: Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
241860|NCT01423604|P1|Participant Flow|Ruxolitinib|"Part 1: Subjects received capecitabine 2000 mg/m^2 (1000 mg/m^2 twice a day (BID)) + ruxolitinib 15 mg BID.~Part 2: Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID])."
241861|NCT01423604|O2|Outcome|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
241862|NCT01423604|O1|Outcome|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
241863|NCT01423604|O2|Outcome|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
241864|NCT01423604|O1|Outcome|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
241865|NCT01423604|O2|Outcome|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
241866|NCT01423604|O1|Outcome|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
241867|NCT01423604|O2|Outcome|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
241868|NCT01423604|O1|Outcome|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
241869|NCT01423604|O2|Outcome|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
241870|NCT01423604|O1|Outcome|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
241871|NCT01423604|E3|Reported Event|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
241872|NCT01423604|E2|Reported Event|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
241873|NCT01423604|E1|Reported Event|Ruxolitinib (Safety Run-In)|Subjects received capecitabine 2000 mg/m^2 daily (taken as 1000 mg/m2 twice daily [BID]) + ruxolitinib 15 mg BID
241874|NCT01423253|B1|Baseline|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
241875|NCT01423253|P1|Participant Flow|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
241876|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
241877|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
241878|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
241879|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
241880|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
241881|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
241882|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
241883|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
241884|NCT01423253|E1|Reported Event|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
241885|NCT01423162|B3|Baseline|Total|Total of all reporting groups
241886|NCT01423162|B2|Baseline|Drink Without Vit C Then Drink With Vit C|Dietary Intervention (without Vitamin C): Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C
241887|NCT01423162|B1|Baseline|Drink With Vit C Then Drink Without Vit C|Dietary Intervention (with Vitamin C): Fortified oat drink with vitamin C followed by fortified oat drink without Vit C
241888|NCT01423162|P2|Participant Flow|Drink Without Vitamin C Then Drink With Vit C|Dietary Intervention: Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C.
241889|NCT01423162|P1|Participant Flow|Drink With Vit C Then Drink Without Vit C|Dietary Intervention: Fortified oat drink with vitamin C followed by fortified oat drink without viatamin C
241890|NCT01423162|O2|Outcome|Fortified Oat Drink Without Vitamin C|
241891|NCT01423162|O1|Outcome|Fortified Oat Drink With Vitamin C|
241892|NCT01423162|E2|Reported Event|Drink Without Vitamin C Then Drink With Vit C|Dietary Intervention: Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C.
241893|NCT01423162|E1|Reported Event|Drink With Vit C Then Drink Without Vit C|Dietary Intervention: Fortified oat drink with vitamin C followed by fortified oat drink without viatamin C
241894|NCT01423084|B3|Baseline|Total|Total of all reporting groups
241895|NCT01423084|B2|Baseline|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
241896|NCT01423084|B1|Baseline|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
241897|NCT01423084|P2|Participant Flow|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
241898|NCT01423084|P1|Participant Flow|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
241899|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
241900|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
241901|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
241902|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
241903|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
241904|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
241905|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
241906|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
241907|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
241908|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
241909|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
241910|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
241911|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
241912|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
241913|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
241914|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
241915|NCT01423084|O2|Outcome|MenB Lot 2|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
241916|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
241917|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
241918|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
241919|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
241920|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
241921|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
241922|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
242029|NCT01422538|O3|Outcome|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment
241925|NCT01423084|E2|Reported Event|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
241926|NCT01423084|E1|Reported Event|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
241927|NCT01422915|B1|Baseline|Colestipol Therapy of Protoporphyria|4 subjects were assigned, all between 18-65 years of age.
241928|NCT01422915|P1|Participant Flow|Colestipol Treatment|Colestipol 2 grams twice daily for 5-6 months. Completion of sun sensitivity questionnaire and blood protoporphyrin concentrations. were obtained monthly.
241929|NCT01422915|O1|Outcome|Colestipol Treatment|Sun sensitivity and protoporphyrin levels
241930|NCT01422915|O1|Outcome|Colestipol Treatment|"gram morning and bedtime for 90 days; then~grams morning and bedtime for 90 days. Sun sensitivity questionnaires and blood protoporphyrin concns. were determined monthly."
241931|NCT01422915|E1|Reported Event|1st Period - Colestipol Optimal Dosage|"gram morning and bedtime for 90 days; then~grams morning and bedtime for 90 days. Sun sensitivity questionnaires and blood protoporphyrin concentrations were determined monthly."
241932|NCT01422889|B1|Baseline|ION Registry|The ION Registry population contains 1120 enrolled subjects with 1111 eligible for analysis. Subjects eligible for analysis includes subjects with at least one study stent implanted.
241933|NCT01422889|P1|Participant Flow|ION Registry|The ION Registry population consists of 1111 subjects that were enrolled and received a study stent.
241934|NCT01422889|O1|Outcome|ION Registry|The ION Registry includes the 1111 enrolled subjects that received a study stent.
241935|NCT01422889|O1|Outcome|ION Registry|The ION Registry includes the 1111 enrolled subjects that received a study stent.
241936|NCT01422889|E1|Reported Event|ION Registry|The ION Registry population will contain the first 1115 consecutive, consenting patients
241937|NCT01422876|B11|Baseline|Total|Total of all reporting groups
241938|NCT01422876|B10|Baseline|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
241939|NCT01422876|B9|Baseline|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
241940|NCT01422876|B8|Baseline|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
241941|NCT01422876|B7|Baseline|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
241942|NCT01422876|B6|Baseline|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
241943|NCT01422876|B5|Baseline|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
241944|NCT01422876|B4|Baseline|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
241945|NCT01422876|B3|Baseline|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
241946|NCT01422876|B2|Baseline|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
241947|NCT01422876|B1|Baseline|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~. Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
241948|NCT01422876|P10|Participant Flow|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
241949|NCT01422876|P9|Participant Flow|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
241950|NCT01422876|P8|Participant Flow|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
242030|NCT01422538|O2|Outcome|Group B|Subjects received Sculptra® treatment only
241951|NCT01422876|P7|Participant Flow|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
241952|NCT01422876|P6|Participant Flow|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
241953|NCT01422876|P5|Participant Flow|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
241954|NCT01422876|P4|Participant Flow|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
241955|NCT01422876|P3|Participant Flow|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
241956|NCT01422876|P2|Participant Flow|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
241957|NCT01422876|P1|Participant Flow|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin: Oral
241958|NCT01422876|O5|Outcome|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
241959|NCT01422876|O4|Outcome|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
241960|NCT01422876|O3|Outcome|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
241961|NCT01422876|O2|Outcome|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
241962|NCT01422876|O1|Outcome|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
241963|NCT01422876|O5|Outcome|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
241964|NCT01422876|O4|Outcome|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
241965|NCT01422876|O3|Outcome|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
241966|NCT01422876|O2|Outcome|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
241967|NCT01422876|O1|Outcome|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
241968|NCT01422876|O5|Outcome|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
241969|NCT01422876|O4|Outcome|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
241970|NCT01422876|O3|Outcome|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
241971|NCT01422876|O2|Outcome|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
241972|NCT01422876|O1|Outcome|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
241973|NCT01422876|O5|Outcome|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
241974|NCT01422876|O4|Outcome|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
241975|NCT01422876|O3|Outcome|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
241976|NCT01422876|O2|Outcome|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
241977|NCT01422876|O1|Outcome|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
241978|NCT01422876|O5|Outcome|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
241979|NCT01422876|O4|Outcome|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
241980|NCT01422876|O3|Outcome|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
241981|NCT01422876|O2|Outcome|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
241982|NCT01422876|O1|Outcome|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
241983|NCT01422876|O5|Outcome|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
241984|NCT01422876|O4|Outcome|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
241985|NCT01422876|O3|Outcome|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
241986|NCT01422876|O2|Outcome|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
241987|NCT01422876|O1|Outcome|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
241988|NCT01422876|O5|Outcome|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
241989|NCT01422876|O4|Outcome|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Ora"
241990|NCT01422876|O3|Outcome|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
241991|NCT01422876|O2|Outcome|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
241992|NCT01422876|O1|Outcome|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
241993|NCT01422876|O5|Outcome|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
241994|NCT01422876|O4|Outcome|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
241995|NCT01422876|O3|Outcome|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
241996|NCT01422876|O2|Outcome|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
241997|NCT01422876|O1|Outcome|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
241998|NCT01422876|E5|Reported Event|Linagliptin 5 mg|Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral
241999|NCT01422876|E4|Reported Event|Empagliflozin 10 mg|Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral
242000|NCT01422876|E3|Reported Event|Empagliflozin 25 mg|Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral
242001|NCT01422876|E2|Reported Event|Empagliflozin 10 mg/Linagliptin 5 mg|Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral
242002|NCT01422876|E1|Reported Event|Empagliflozin 25 mg/Linagliptin 5 mg|Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral
242003|NCT01422850|B1|Baseline|ALECSAT|
242004|NCT01422850|P1|Participant Flow|ALECSAT|After inclusion in the ALECSAT trial, the subject donates 200 ml blood sample for the first ALECSAT product, and after 6 and 11 weeks the subject donated 200 ml again for the second and third product. ALECSAT was thereafter administered at week 4, 9, and week 14.
242005|NCT01422850|O1|Outcome|ALECSAT|
242006|NCT01422850|O1|Outcome|Trends Towards Possible Treatment Response|No significant conclusion of efficacy is possible due to the study design with only one active group of patients. However by analyzing and comparing the outcome with the data the individual patient presented at baseline some trends of efficacy are possible. Scintigraphy and blood tests (PSA, ALP, LDH and Creatinine)were used for this analysis.
242007|NCT01422850|O1|Outcome|ALCESAT|
242008|NCT01422850|E1|Reported Event|ALECSAT|
242009|NCT01422824|B1|Baseline|Mircera|Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling.
242010|NCT01422824|P1|Participant Flow|Mircera|Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current summaries of product characteristics (SPCs)/local labeling.
242011|NCT01422824|O1|Outcome|Mircera|Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling.
242012|NCT01422824|O1|Outcome|Mircera|Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling.
242013|NCT01422824|E1|Reported Event|Mircera|Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling.
242014|NCT01422720|B1|Baseline|Esl 800 mg|Eslicarbazepine Acetate (Esl) tablets (800 mg) QD
242015|NCT01422720|P1|Participant Flow|Esl 800 mg|Eslicarbazepine Acetate (Esl) tablets (800 mg) QD
242016|NCT01422720|O4|Outcome|PPS- Treatment Period|The Per Protocol Set (PPS) consisted of all subjects in the FAS who had completed the Treatment Period and did not have any protocol deviation (e.g. poor compliance, diaries not properly filled) in a sufficiently serious manner to warrant data (but not subject) exclusion.
242017|NCT01422720|O3|Outcome|PPS - Baseline Period|The Per Protocol Set (PPS) consisted of all subjects in the FAS who had completed the Treatment Period and did not have any protocol deviation (e.g. poor compliance, diaries not properly filled) in a sufficiently serious manner to warrant data (but not subject) exclusion.
242018|NCT01422720|O2|Outcome|FAS - Treatment Period|The Full Analysis Set (FAS) consisted of all subjects who received at least one dose of IMP and had at least one day of seizure evaluation reported in the patient diary after Visit 2.
242019|NCT01422720|O1|Outcome|FAS - Baseline Period|The Full Analysis Set (FAS) consisted of all subjects who received at least one dose of IMP and had at least one day of seizure evaluation reported in the patient diary after Visit 2.
242020|NCT01422720|O1|Outcome|Esl 800 mg|Eslicarbazepine Acetate (Esl) tablets (800 mg) QD
242021|NCT01422720|E1|Reported Event|Esl 800 mg|Eslicarbazepine Acetate (Esl) tablets (800 mg) QD
242022|NCT01422538|B4|Baseline|Total|Total of all reporting groups
242023|NCT01422538|B3|Baseline|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment. Study subjects in Group C received approximately 400 lines of Ultherapy treatment (5.0PLUS Guideline followed).
242024|NCT01422538|B2|Baseline|Group B|Subjects received Sculptra® treatment only
242025|NCT01422538|B1|Baseline|Group A|Subjects received Ultherapy® Treatment only. Study subjects in Group A received approximately 400 lines of Ultherapy treatment (5.0PLUS Guideline followed).
242026|NCT01422538|P3|Participant Flow|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment
242027|NCT01422538|P2|Participant Flow|Group B|Subjects received Sculptra® treatment only
242028|NCT01422538|P1|Participant Flow|Group A|Subjects received Ultherapy® Treatment only.
242031|NCT01422538|O1|Outcome|Group A|Subjects received Ultherapy® Treatment only.
242032|NCT01422538|O3|Outcome|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment
242033|NCT01422538|O2|Outcome|Group B|Subjects received Sculptra® treatment only
242034|NCT01422538|O1|Outcome|Group A|Subjects received Ultherapy® Treatment only.
242035|NCT01422538|O2|Outcome|Group C|Subjects received Sculptra® and Ultherapy® Treatment.
242036|NCT01422538|O1|Outcome|Group A|Subjects received Ultherapy® Treatment only.
242037|NCT01422538|O3|Outcome|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment
242038|NCT01422538|O2|Outcome|Group B|Subjects received Sculptra® treatment only
242039|NCT01422538|O1|Outcome|Group A|Subjects received Ultherapy® Treatment only.
242040|NCT01422538|O3|Outcome|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment
242041|NCT01422538|O2|Outcome|Group B|Subjects received Sculptra® treatment only
242042|NCT01422538|O1|Outcome|Group A|Subjects received Ultherapy® Treatment only.
242043|NCT01422538|O3|Outcome|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment
242044|NCT01422538|O2|Outcome|Group B|Subjects received Sculptra® treatment only
242045|NCT01422538|O1|Outcome|Group A|Subjects received Ultherapy® Treatment only.
242046|NCT01422538|E3|Reported Event|Group C|Subjects received Sculptra® and Ultherapy® Treatment.
242047|NCT01422538|E2|Reported Event|Group B|Subjects received Sculptra® only.
242048|NCT01422538|E1|Reported Event|Group A|Subjects received Ultherapy® Treatment only.
242049|NCT01422434|B4|Baseline|Total|Total of all reporting groups
242050|NCT01422434|B3|Baseline|Rinderon® - DP Ointment|"Applied once daily for 4 weeks~Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
242051|NCT01422434|B2|Baseline|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.~LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
242052|NCT01422434|B1|Baseline|Dovonex® Ointment|"Applied twice daily for 4 weeks.~Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
242053|NCT01422434|P3|Participant Flow|Rinderon® - DP Ointment (Betamethasone Dipropionate)|"Applied once daily for 4 weeks~Rinderon® - DP ointment ( betamethasone dipropionate) : Applied once daily for 4 weeks."
242054|NCT01422434|P2|Participant Flow|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.~LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
242055|NCT01422434|P1|Participant Flow|Dovonex® Ointment|"Applied twice daily for 4 weeks.~Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
242056|NCT01422434|O3|Outcome|Rinderon® - DP Ointment|"Applied once daily for 4 weeks~Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
242057|NCT01422434|O2|Outcome|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.~LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
242058|NCT01422434|O1|Outcome|Dovonex® Ointment|"Applied twice daily for 4 weeks.~Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
242059|NCT01422434|O3|Outcome|Rinderon® - DP Ointment|"Applied once daily for 4 weeks~Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
242060|NCT01422434|O2|Outcome|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.~LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
242061|NCT01422434|O1|Outcome|Dovonex® Ointment|"Applied twice daily for 4 weeks.~Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
242062|NCT01422434|O3|Outcome|Rinderon® - DP Ointment|"Applied once daily for 4 weeks~Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
242063|NCT01422434|O2|Outcome|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.~LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
242064|NCT01422434|O1|Outcome|Dovonex® Ointment|"Applied twice daily for 4 weeks.~Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
242065|NCT01422434|O3|Outcome|Rinderon® - DP Ointment|"Applied once daily for 4 weeks~Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
242066|NCT01422434|O2|Outcome|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.~LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
242067|NCT01422434|O1|Outcome|Dovonex® Ointment|"Applied twice daily for 4 weeks.~Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
242068|NCT01422434|E3|Reported Event|Rinderon® - DP Ointment|"Applied once daily for 4 weeks~Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
242069|NCT01422434|E2|Reported Event|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.~LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
242070|NCT01422434|E1|Reported Event|Dovonex® Ointment|"Applied twice daily for 4 weeks.~Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
242071|NCT01422408|B1|Baseline|Supportive Care|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242072|NCT01422408|P1|Participant Flow|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242073|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242074|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
263770|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
242075|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242076|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242077|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242078|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242079|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242080|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242081|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242082|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242083|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242084|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242085|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242086|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242087|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242088|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242089|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242090|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242091|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242092|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242093|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242177|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
242178|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
242179|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
242094|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242095|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242096|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242097|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242098|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242099|NCT01422408|E1|Reported Event|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.~All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
242100|NCT01422382|B1|Baseline|All Subjects|All randomized subjects.
242101|NCT01422382|P1|Participant Flow|All Subjects|All randomized subjects.
242102|NCT01422382|O1|Outcome|All Subjects|All randomized subjects.
242103|NCT01422382|O1|Outcome|All Subjects|All randomized subjects.
242104|NCT01422382|E1|Reported Event|All Subjects|All randomized subjects.
242105|NCT01422369|B1|Baseline|All Subjects|All randomized subjects
242106|NCT01422369|P1|Participant Flow|All Subjects|All randomized subjects
242107|NCT01422369|O1|Outcome|All Subjects|All randomized subjects
242108|NCT01422369|O1|Outcome|NK-104|NK-104 4mg once daily (QD)
242109|NCT01422369|E1|Reported Event|All Subjects|All randomized subjects
242110|NCT01422356|B1|Baseline|12 Month Cohort|
242111|NCT01422356|P1|Participant Flow|12 Month Cohort|16-20 year old males
242112|NCT01422356|O1|Outcome|Baseline Prevalence|
242113|NCT01422356|E1|Reported Event|12 Month Cohort|
242114|NCT01422304|B3|Baseline|Total|Total of all reporting groups
242115|NCT01422304|B2|Baseline|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
242116|NCT01422304|B1|Baseline|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
242117|NCT01422304|P2|Participant Flow|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
242118|NCT01422304|P1|Participant Flow|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
242119|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
242120|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
242121|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
242122|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
242123|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
242124|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
242125|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
242126|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
242127|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
242128|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
242129|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
242130|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
242131|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
242132|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
242133|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
242134|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
242149|NCT01422239|B1|Baseline|Tailored Behavioral Counseling|"The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. The last 5 counseling sessions will be based on perceived risks of quitting."
242135|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
242136|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
242137|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
242138|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
242139|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
242140|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
242141|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
242142|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
242143|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
242144|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
242145|NCT01422304|E2|Reported Event|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
242146|NCT01422304|E1|Reported Event|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
242147|NCT01422239|B3|Baseline|Total|Total of all reporting groups
242148|NCT01422239|B2|Baseline|Standard Behavioral Counseling|"The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual."
242174|NCT01422213|P2|Participant Flow|Vortioxetine 10 mg|encapsulated tablets; daily; orally
242175|NCT01422213|P1|Participant Flow|Placebo|capsules; daily; orally
242176|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
242299|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
242150|NCT01422239|P2|Participant Flow|Standard Behavioral Counseling|The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's smoking cessation manual. All of the material for sessions 4-8 for the standard behavioral counseling condition will cover topics from the Mayo Clinic's smoking cessation manual - Session 4: coping with triggers to smoke and nicotine withdrawal, Session 5: Stress Management, Session 6: Time Management and Self-Image, Session 7: Communication Skills and Wellness, Session 8: Focusing on the Future (maintenance of smoking abstinence).
242151|NCT01422239|P1|Participant Flow|Tailored Behavioral Counseling|The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session, coping with withdrawal symptoms in the third session, and on coping with triggers and withdrawal in the forth session using the Mayo Clinic's smoking cessation manual. The focus of sessions 5-7 will be the three perceive risks of quitting that were not covered during the first three session (i.e., the three least highly endorsed risks). Session 8 will cover maintenance of smoking abstinence using the Mayo Clinic manual.
242152|NCT01422239|O2|Outcome|Standard Behavioral Counseling|"The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual."
242153|NCT01422239|O1|Outcome|Tailored Behavioral Counseling|"The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. The last 5 counseling sessions will be based on perceived risks of quitting."
242154|NCT01422239|O2|Outcome|Standard Behavioral Counseling|"The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual."
242155|NCT01422239|O1|Outcome|Tailored Behavioral Counseling|"The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. The last 5 counseling sessions will be based on perceived risks of quitting."
242156|NCT01422239|O2|Outcome|Standard Behavioral Counseling|"The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual."
242157|NCT01422239|O1|Outcome|Tailored Behavioral Counseling|"The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. The last 5 counseling sessions will be based on perceived risks of quitting."
242158|NCT01422239|E2|Reported Event|Standard Behavioral Counseling|"The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual."
242159|NCT01422239|E1|Reported Event|Tailored Behavioral Counseling|"The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. The last 5 counseling sessions will be based on perceived risks of quitting."
242160|NCT01422226|B3|Baseline|Total|Total of all reporting groups
242161|NCT01422226|B2|Baseline|Placebo Comparator|Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
242162|NCT01422226|B1|Baseline|Experimental Active Comparator|Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
242163|NCT01422226|P2|Participant Flow|Placebo Comparator|Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
242164|NCT01422226|P1|Participant Flow|Experimental Active Comparator|Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
242165|NCT01422226|O2|Outcome|Placebo Comparator|Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
242166|NCT01422226|O1|Outcome|Experimental Active Comparator|Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
242167|NCT01422226|E2|Reported Event|Placebo Comparator|Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
242168|NCT01422226|E1|Reported Event|Experimental Active Comparator|Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
242169|NCT01422213|B4|Baseline|Total|Total of all reporting groups
242170|NCT01422213|B3|Baseline|Vortioxetine 20 mg|encapsulated tablets, daily, orally
242171|NCT01422213|B2|Baseline|Vortioxetine 10 mg|encapsulated tablets, daily, orally
242172|NCT01422213|B1|Baseline|Placebo|capsules, daily, orally
242173|NCT01422213|P3|Participant Flow|Vortioxetine 20 mg|encapsulated tablets; daily; orally
242180|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
242181|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
242182|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
242183|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
242184|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
242185|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
242186|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
242187|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
242188|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
242189|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
242190|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
242191|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
242192|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
242193|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
242194|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
242195|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
242196|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
242197|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
242198|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
242199|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
242200|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
242201|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
242202|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
242203|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
242204|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
242205|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
242206|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
242207|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
242208|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
242209|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
242210|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
242211|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
242212|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
242213|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
242214|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
242215|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
242216|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
242217|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
242218|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
242219|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
242220|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
242221|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
242222|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
242223|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
242224|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
242225|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
242226|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
242227|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
242228|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
242229|NCT01422213|E3|Reported Event|Vortioxetine 20 mg|
242230|NCT01422213|E2|Reported Event|Vortioxetine 10 mg|
242231|NCT01422213|E1|Reported Event|Placebo|
242232|NCT01422187|B4|Baseline|Total|Total of all reporting groups
242233|NCT01422187|B3|Baseline|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
242234|NCT01422187|B2|Baseline|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
242235|NCT01422187|B1|Baseline|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
242236|NCT01422187|P3|Participant Flow|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
242237|NCT01422187|P2|Participant Flow|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
242238|NCT01422187|P1|Participant Flow|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
242239|NCT01422187|O3|Outcome|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
242240|NCT01422187|O2|Outcome|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
242241|NCT01422187|O1|Outcome|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
242242|NCT01422187|O3|Outcome|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
242243|NCT01422187|O2|Outcome|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
242244|NCT01422187|O1|Outcome|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
242245|NCT01422187|O3|Outcome|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
242246|NCT01422187|O2|Outcome|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
242247|NCT01422187|O1|Outcome|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
242248|NCT01422187|O3|Outcome|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
242249|NCT01422187|O2|Outcome|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
242250|NCT01422187|O1|Outcome|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
242251|NCT01422187|E3|Reported Event|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
242252|NCT01422187|E2|Reported Event|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
242253|NCT01422187|E1|Reported Event|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
242254|NCT01422070|B3|Baseline|Total|Total of all reporting groups
242255|NCT01422070|B2|Baseline|Units Without Intermediate Care Unit|Patients admitted to intensive care unit without intermediate care unit in the hospital
242256|NCT01422070|B1|Baseline|Units With Intermediate Care Unit|Patients admitted to intensive care unit with intermediate care unit in the hospital
242257|NCT01422070|P2|Participant Flow|Units in Hospitals Without Intermediate Care Unit|Adult patients consecutively admitted to Intensive Care Units in hospitals without intermediate care unit
242258|NCT01422070|P1|Participant Flow|Units in Hospitals With Intermediate Care Unit|Adult patients consecutively admitted to Intensive Care Units in hospitals with intermediate care unit
242259|NCT01422070|O2|Outcome|Units in Hospitals Without Intermediate Care Unit|Patients admitted to intensive care unit without intermediate care unit in the hospital
242260|NCT01422070|O1|Outcome|Units in Hospitals With Intermediate Care Unit|Patients admitted to intensive care unit with intermediate care unit in the hospital
242261|NCT01422070|O2|Outcome|Units in Hospitals Without Intermediate Care Unit|Patients admitted to intensive care unit without intermediate care unit in the hospital
242262|NCT01422070|O1|Outcome|Units in Hospitals With Intermediate Care Unit|Patients admitted to intensive care unit with intermediate care unit in the hospital
242263|NCT01422070|O2|Outcome|Units in Hospitals Without Intermediate Care Unit|Patients admitted to intensive care unit without intermediate care unit in the hospital
242264|NCT01422070|O1|Outcome|Units in Hospitals With Intermediate Care Unit|Patients admitted to intensive care unit with intermediate care unit in the hospital
242265|NCT01422070|O2|Outcome|Units in Hospitals Without Intermediate Care Unit|Patients admitted to intensive care unit without intermediate care unit in the hospital
242266|NCT01422070|O1|Outcome|Units in Hospitals With Intermediate Care Unit|Patients admitted to intensive care unit with intermediate care unit in the hospital
242267|NCT01422070|E1|Reported Event|Adverse Events Not Collected|Adverse events were not collected
242268|NCT01421719|B1|Baseline|Botulinum Toxin Treatment|Injection of Botox into urinary bladder for neurogenic symptoms.
242269|NCT01421719|P1|Participant Flow|Botulinum Toxin Treatment|Injection of Botox into urinary bladder for neurogenic symptoms.
242270|NCT01421719|O1|Outcome|Botulinum Toxin Treatment|Injection of Botox into urinary bladder for neurogenic symptoms.
242271|NCT01421719|O1|Outcome|Urinary Leaks Per Day|3-day voiding diary produced the clinical observation as an average per evaluation milestone.
242272|NCT01421719|E1|Reported Event|Botulinum Toxin Treatment|Injection of Botox into urinary bladder for neurogenic symptoms.
242273|NCT01421667|B5|Baseline|Total|Total of all reporting groups
242274|NCT01421667|B4|Baseline|CD30+ DLBCL, BV+R|
242275|NCT01421667|B3|Baseline|CD30u DLBCL, BV|
242276|NCT01421667|B2|Baseline|CD30+ B-Cell NHL, BV|
242277|NCT01421667|B1|Baseline|CD30+ T-Cell NHL, BV|
242278|NCT01421667|P4|Participant Flow|CD30+ DLBCL, BV+R|Part B - Brentuximab vedotin (BV) 1.8 mg/kg plus rituximab (R; first 8 cycles only) (375 mg/m2) every 3 weeks by intravenous (IV) infusion in patients with CD30-positive diffuse large B-cell lymphoma (DLBCL)
242279|NCT01421667|P3|Participant Flow|CD30u DLBCL, BV|Part C - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with diffuse large B-cell lymphoma (DLBCL) with undetectable CD30 (CD30u)
242280|NCT01421667|P2|Participant Flow|CD30+ B-Cell NHL, BV|Part A - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive B-cell non-Hodgkin lymphomas (NHL), including CD30-positive diffuse large B-cell lymphoma (DLBCL) and other CD30-positive B-cell NHLs
242281|NCT01421667|P1|Participant Flow|CD30+ T-Cell NHL, BV|Part A - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in with CD30-positive mature T-cell non-Hodgkin lymphomas (NHL)
242282|NCT01421667|O3|Outcome|CD30u DLBCL, BV|
242283|NCT01421667|O2|Outcome|CD30+ B-Cell NHL, BV|
242284|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
242285|NCT01421667|O3|Outcome|CD30u DLBCL, BV|
242286|NCT01421667|O2|Outcome|CD30+ B-Cell NHL, BV|
242287|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
242288|NCT01421667|O3|Outcome|CD30u DLBCL, BV|
242289|NCT01421667|O2|Outcome|CD30+ B-Cell NHL, BV|
242290|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
242291|NCT01421667|O3|Outcome|CD30u DLBCL, BV|
242292|NCT01421667|O2|Outcome|CD30+ B-Cell NHL, BV|
242293|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
242294|NCT01421667|O3|Outcome|CD30u DLBCL, BV|
242295|NCT01421667|O2|Outcome|CD30+ B-Cell NHL, BV|
242296|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
242297|NCT01421667|O3|Outcome|CD30u DLBCL, BV|
242298|NCT01421667|O2|Outcome|CD30+ B-Cell NHL, BV|
242322|NCT01421667|O1|Outcome|CD30+ DLBCL, BV+R|Part B - CD30-positive diffuse large B-cell lymphoma (DLBCL) includes only the pathological diagnosis of DLBCL.
242323|NCT01421667|O4|Outcome|CD30u DLBCL, BV|Part C - CD30u diffuse large B-cell lymphoma (DLBCL) includes only the pathological diagnosis of DLBCL.
242324|NCT01421667|O3|Outcome|CD30+ DLBCL, BV|Part A - CD30-positive diffuse large B-cell lymphoma (DLBCL) include pathological diagnoses of DLBCL, Epstein-Barr Virus (EBV)-associated DLBCL of the elderly, and T-cell rich B-cell lymphoma.
242325|NCT01421667|O2|Outcome|CD30+ Other B-Cell NHL, BV|Part A - CD30-positive other B-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of follicular lymphoma, gray zone lymphoma, primary mediastinal B-cell lymphoma (PMBL), post-transplant lymphoproliferative disease (PTLD), and plasmablastic lymphoma.
242326|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|Part A - CD30-positive T-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of angioimmunoblastic T-cell lymphoma (AITL) and peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS).
242327|NCT01421667|E3|Reported Event|CD30+ DLBCL, BV+R|Brentuximab vedotin (BV) 1.8 mg/kg plus rituximab (R; first 8 cycles only) (375 mg/m2) every 3 weeks by intravenous (IV) infusion in patients in Part B with diffuse large B-cell lymphoma (DLBCL)
242328|NCT01421667|E2|Reported Event|CD30u DLBCL, BV|Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in Part C with diffuse large B-cell lymphoma (DLBCL) with undetectable CD30 (CD30u)
242329|NCT01421667|E1|Reported Event|CD30+ NHL (T-Cell and B-Cell), BV|Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in with CD30-positive non-Hodgkin lymphomas (NHL), including T-cell lymphomas and B-cell lymphomas, as well as diffuse large B-cell lymphoma (DLBCL)
242330|NCT01421654|B3|Baseline|Total|Total of all reporting groups
242331|NCT01421654|B2|Baseline|Fixed Mode Only|S9 Elite Flow Generator with Fixed Mode only
242332|NCT01421654|B1|Baseline|Fixed Mode + Acclimate|S9 Elite flow generator with Acclimate feature activated.
242333|NCT01421654|P2|Participant Flow|Fixed Mode Only|S9 Elite Flow Generator with Fixed Mode only
242334|NCT01421654|P1|Participant Flow|Fixed Mode + Acclimate|S9 Elite flow generator with Acclimate feature activated.
242335|NCT01421654|O2|Outcome|Fixed Mode Only|S9 Elite Flow Generator with Fixed Mode only
242336|NCT01421654|O1|Outcome|Fixed Mode + Acclimate|S9 Elite flow generator with Acclimate feature activated.
242337|NCT01421654|E2|Reported Event|Fixed Mode Only|S9 Elite Flow Generator with Fixed Mode only
242338|NCT01421654|E1|Reported Event|Fixed Mode + Acclimate|S9 Elite flow generator with Acclimate feature activated.
242339|NCT01421641|B3|Baseline|Total|Total of all reporting groups
242340|NCT01421641|B2|Baseline|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
242341|NCT01421641|B1|Baseline|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
242342|NCT01421641|P2|Participant Flow|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
242343|NCT01421641|P1|Participant Flow|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
242344|NCT01421641|O2|Outcome|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
242345|NCT01421641|O1|Outcome|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
242346|NCT01421641|O2|Outcome|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
242347|NCT01421641|O1|Outcome|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
242348|NCT01421641|O2|Outcome|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
242349|NCT01421641|O1|Outcome|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
242350|NCT01421641|E2|Reported Event|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
242351|NCT01421641|E1|Reported Event|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
242352|NCT01421589|B1|Baseline|Growth Hormone|Growth hormone treatment: Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
242353|NCT01421589|P1|Participant Flow|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
242354|NCT01421589|O1|Outcome|Growth Hormone|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
242355|NCT01421589|O1|Outcome|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
242356|NCT01421589|O1|Outcome|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
242357|NCT01421589|O1|Outcome|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
242358|NCT01421589|O1|Outcome|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
242359|NCT01421589|O1|Outcome|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
242360|NCT01421589|O1|Outcome|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
242361|NCT01421589|E1|Reported Event|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
242362|NCT01421511|B3|Baseline|Total|Total of all reporting groups
242363|NCT01421511|B2|Baseline|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
242364|NCT01421511|B1|Baseline|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo.
242365|NCT01421511|P2|Participant Flow|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
242366|NCT01421511|P1|Participant Flow|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
242367|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
242368|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
242369|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
242370|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
242371|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
242372|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
242373|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
242374|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
242375|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
242376|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
242377|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
242378|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
242379|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
242380|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
242381|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
242382|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo.
242383|NCT01421511|E2|Reported Event|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
242384|NCT01421511|E1|Reported Event|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
242385|NCT01421498|B3|Baseline|Total|Total of all reporting groups
242386|NCT01421498|B2|Baseline|Placebo|
242387|NCT01421498|B1|Baseline|Lifitegrast 5.0%|
242388|NCT01421498|P2|Participant Flow|Placebo|
242389|NCT01421498|P1|Participant Flow|Lifitegrast 5.0%|
242390|NCT01421498|O2|Outcome|Placebo|
242391|NCT01421498|O1|Outcome|Lifitegrast 5.0%|
242392|NCT01421498|O2|Outcome|Placebo|
242393|NCT01421498|O1|Outcome|Lifitegrast 5.0%|
242394|NCT01421498|E2|Reported Event|Placebo|
242395|NCT01421498|E1|Reported Event|Lifitegrast 5.0%|
242396|NCT01421472|B5|Baseline|Total|Total of all reporting groups
242397|NCT01421472|B4|Baseline|TN: Paclitaxel|"Triple negative (TN) patients randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
242398|NCT01421472|B3|Baseline|TN: MM-121 + Paclitaxel|"Triple Negative (TN) patients randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
242399|NCT01421472|B2|Baseline|HR+: Paclitaxel Only|"Hormone-receptor positive (HR+) sub-group randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
242400|NCT01421472|B1|Baseline|HR+: MM-121+ Paclitaxel|"Hormone-receptor positive (HR+) sub-group randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
242401|NCT01421472|P4|Participant Flow|TN: Paclitaxel|"Triple negative (TN) patients randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
242402|NCT01421472|P3|Participant Flow|TN: MM-121 + Paclitaxel|"Triple Negative (TN) patients randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
242403|NCT01421472|P2|Participant Flow|HR+: Paclitaxel Only|"Hormone-receptor positive (HR+) sub-group randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
242404|NCT01421472|P1|Participant Flow|HR+: MM-121+ Paclitaxel|"Hormone-receptor positive (HR+) sub-group randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
242405|NCT01421472|O4|Outcome|TN: Paclitaxel|"Triple negative (TN) patients randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
242434|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
242406|NCT01421472|O3|Outcome|TN: MM-121 + Paclitaxel|"Triple Negative (TN) patients randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
242407|NCT01421472|O2|Outcome|HR+: Paclitaxel Only|"Hormone-receptor positive (HR+) sub-group randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
242408|NCT01421472|O1|Outcome|HR+: MM-121+ Paclitaxel|"Hormone-receptor positive (HR+) sub-group randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
242409|NCT01421472|E4|Reported Event|TN: Paclitaxel|"Triple negative (TN) patients randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
242410|NCT01421472|E3|Reported Event|TN: MM-121 + Paclitaxel|"Triple Negative (TN) patients randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
242411|NCT01421472|E2|Reported Event|HR+: Paclitaxel Only|"Hormone-receptor positive (HR+) sub-group randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
242412|NCT01421472|E1|Reported Event|HR+: MM-121+ Paclitaxel|"Hormone-receptor positive (HR+) sub-group randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
242413|NCT01421459|B3|Baseline|Total|Total of all reporting groups
242414|NCT01421459|B2|Baseline|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
242415|NCT01421459|B1|Baseline|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
242416|NCT01421459|P2|Participant Flow|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
242417|NCT01421459|P1|Participant Flow|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
242418|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
242419|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
242420|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
242421|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
242422|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
242423|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
242424|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
242425|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
242426|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
242427|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
242428|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
242429|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
242430|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
242431|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
242432|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
242433|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
242435|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
242436|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
242437|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
242438|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
242439|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
242440|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
242441|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
242442|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
242443|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
242444|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
242445|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
242446|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
242447|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
242448|NCT01421459|E2|Reported Event|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
242449|NCT01421459|E1|Reported Event|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
242450|NCT01421355|B1|Baseline|Atazanavir 300 mg BID|"Atazanavir 300 mg BID for 4 days.~Atazanavir: The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug."
242451|NCT01421355|P1|Participant Flow|Atazanavir 300 mg BID|"Atazanavir 300 mg BID for 4 days.~Atazanavir: The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug."
242452|NCT01421355|O1|Outcome|Atazanavir 300 mg BID|"Atazanavir 300 mg BID for 4 days.~Atazanavir: The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug."
242453|NCT01421355|E1|Reported Event|Atazanavir 300 mg BID|"Atazanavir 300 mg BID for 4 days.~Atazanavir: The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug."
242454|NCT01421342|B4|Baseline|Total|Total of all reporting groups
242455|NCT01421342|B3|Baseline|Augmenting: Antidepressant + Aripiprazole|"Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.~And~Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."
242456|NCT01421342|B2|Baseline|Augmenting: Antidepressant + Bupropion-SR|"Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.~And~Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."
242457|NCT01421342|B1|Baseline|Switching: Bupropion-SR|Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
242458|NCT01421342|P3|Participant Flow|Augmenting: Antidepressant + Aripiprazole|"Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.~And~Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."
242563|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
242564|NCT01421134|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
242459|NCT01421342|P2|Participant Flow|Augmenting: Antidepressant + Bupropion-SR|"Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.~And~Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."
242460|NCT01421342|P1|Participant Flow|Switching: Bupropion-SR|Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
242461|NCT01421342|O3|Outcome|Augmenting: Antidepressant + Aripiprazole|"Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.~And~Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."
242462|NCT01421342|O2|Outcome|Augmenting: Antidepressant + Bupropion-SR|"Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.~And~Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."
242463|NCT01421342|O1|Outcome|Switching: Bupropion-SR|Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
242464|NCT01421342|O3|Outcome|Augmenting: Antidepressant + Aripiprazole|"Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.~And~Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."
242465|NCT01421342|O2|Outcome|Augmenting: Antidepressant + Bupropion-SR|"Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.~And~Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."
242466|NCT01421342|O1|Outcome|Switching: Bupropion-SR|Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
242467|NCT01421342|O3|Outcome|Augmenting: Antidepressant + Aripiprazole|"Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.~And~Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."
242468|NCT01421342|O2|Outcome|Augmenting: Antidepressant + Bupropion-SR|"Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.~And~Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."
242469|NCT01421342|O1|Outcome|Switching: Bupropion-SR|Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
242470|NCT01421342|O3|Outcome|Augmenting: Antidepressant + Aripiprazole|"Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.~And~Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."
242471|NCT01421342|O2|Outcome|Augmenting: Antidepressant + Bupropion-SR|"Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.~And~Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."
242493|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
242472|NCT01421342|O1|Outcome|Switching: Bupropion-SR|Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
242473|NCT01421342|E3|Reported Event|Augmenting: Antidepressant + Aripiprazole|"Augmenting: Antidepressant + Aripiprazole~Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.~And~Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."
242474|NCT01421342|E2|Reported Event|Augmenting: Antidepressant + Bupropion-SR|"Augmenting: Antidepressant + Bupropion-SR~Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.~And~Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."
242475|NCT01421342|E1|Reported Event|Switching: Bupropion-SR|"Switching: Bupropion-SR~Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."
242476|NCT01421303|B1|Baseline|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
242477|NCT01421303|P1|Participant Flow|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
242478|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
242479|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
242480|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
242481|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
242482|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
242483|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
242484|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
242485|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
242486|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
242487|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
242488|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
242489|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
242490|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
242491|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
242492|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
242557|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
242558|NCT01421134|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
242494|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
242495|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
242496|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
242497|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
242498|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
242499|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
242500|NCT01421303|E1|Reported Event|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
242501|NCT01421277|B3|Baseline|Total|Total of all reporting groups
242502|NCT01421277|B2|Baseline|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
242503|NCT01421277|B1|Baseline|Participants Enrolled in Protocol Version V1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
242504|NCT01421277|P2|Participant Flow|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
242505|NCT01421277|P1|Participant Flow|Participants Enrolled in Protocol Version (V)1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
242506|NCT01421277|O2|Outcome|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
242507|NCT01421277|O1|Outcome|Participants Enrolled in Protocol Version V1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
242508|NCT01421277|O2|Outcome|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
242509|NCT01421277|O1|Outcome|Participants Enrolled in Protocol Version V1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
242510|NCT01421277|O2|Outcome|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
242511|NCT01421277|O1|Outcome|Participants Enrolled in Protocol Version V1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
242512|NCT01421277|E2|Reported Event|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
242513|NCT01421277|E1|Reported Event|Participants Enrolled in Protocol Version V1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
242514|NCT01421147|B3|Baseline|Total|Total of all reporting groups
242515|NCT01421147|B2|Baseline|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242516|NCT01421147|B1|Baseline|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242559|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
242560|NCT01421134|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
263849|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
242517|NCT01421147|P2|Participant Flow|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242518|NCT01421147|P1|Participant Flow|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242519|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242520|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242521|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242522|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242523|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242524|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242525|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242526|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242527|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242528|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242529|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242530|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242531|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242532|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242561|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
242562|NCT01421134|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
242533|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242534|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242535|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242536|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242537|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242538|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242539|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242540|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242541|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242542|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242543|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242544|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242545|NCT01421147|E2|Reported Event|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242546|NCT01421147|E1|Reported Event|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
242547|NCT01421134|B3|Baseline|Total|Total of all reporting groups
242548|NCT01421134|B2|Baseline|Placebo|"Placebo~Placebo: Placebo"
242549|NCT01421134|B1|Baseline|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
242550|NCT01421134|P2|Participant Flow|Placebo|"Placebo~Placebo: Placebo"
242551|NCT01421134|P1|Participant Flow|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
242552|NCT01421134|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
242553|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
242554|NCT01421134|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
242555|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
242556|NCT01421134|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
242565|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
242566|NCT01421134|E2|Reported Event|Placebo|"Placebo~Placebo: Placebo"
242567|NCT01421134|E1|Reported Event|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
242568|NCT01420926|B3|Baseline|Total|Total of all reporting groups
242569|NCT01420926|B2|Baseline|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
242570|NCT01420926|B1|Baseline|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
242571|NCT01420926|P2|Participant Flow|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
242572|NCT01420926|P1|Participant Flow|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
242573|NCT01420926|O2|Outcome|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
242574|NCT01420926|O1|Outcome|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
242575|NCT01420926|O2|Outcome|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
242576|NCT01420926|O1|Outcome|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
242590|NCT01420848|P2|Participant Flow|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
242591|NCT01420848|P1|Participant Flow|Auriculotherapy Group|"The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.~Two points were chosen to treat stress and anxiety (Shenmen and Brainstem).~Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological."
242577|NCT01420926|O2|Outcome|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
242578|NCT01420926|O1|Outcome|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
242579|NCT01420926|O2|Outcome|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
242580|NCT01420926|O1|Outcome|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
242581|NCT01420926|O2|Outcome|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
242582|NCT01420926|O1|Outcome|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
242583|NCT01420926|E2|Reported Event|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
242584|NCT01420926|E1|Reported Event|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
242585|NCT01420848|B4|Baseline|Total|Total of all reporting groups
242586|NCT01420848|B3|Baseline|Placebo Group|Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
242587|NCT01420848|B2|Baseline|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
242588|NCT01420848|B1|Baseline|Auriculotherapy Group|"The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.~Two points were chosen to treat stress and anxiety (Shenmen and Brainstem).~Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological."
242589|NCT01420848|P3|Participant Flow|Placebo Group|Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
263850|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
242592|NCT01420848|O3|Outcome|Placebo Group|Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
242593|NCT01420848|O2|Outcome|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
242594|NCT01420848|O1|Outcome|Auriculotherapy Group|"The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.~Two points were chosen to treat stress and anxiety (Shenmen and Brainstem).~Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological."
242595|NCT01420848|O3|Outcome|Placebo Group|Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
242596|NCT01420848|O2|Outcome|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
242597|NCT01420848|O1|Outcome|Auriculotherapy Group|"The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.~Two points were chosen to treat stress and anxiety (Shenmen and Brainstem).~Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological."
242598|NCT01420848|E3|Reported Event|Placebo Group|Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
242599|NCT01420848|E2|Reported Event|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
242600|NCT01420848|E1|Reported Event|Auriculotherapy Group|"The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.~Two points were chosen to treat stress and anxiety (Shenmen and Brainstem).~Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological."
242601|NCT01420289|B3|Baseline|Total|Total of all reporting groups
242602|NCT01420289|B2|Baseline|Excercise|Walking on a graded treadmill for 45 minutes once daily
242603|NCT01420289|B1|Baseline|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
242604|NCT01420289|P2|Participant Flow|Excercise|Walking on a graded treadmill for 45 minutes once daily
242605|NCT01420289|P1|Participant Flow|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
242606|NCT01420289|O2|Outcome|Excercise|Walking on a graded treadmill for 45 minutes once daily
242607|NCT01420289|O1|Outcome|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
242608|NCT01420289|O2|Outcome|Excercise|Walking on a graded treadmill for 45 minutes once daily
242609|NCT01420289|O1|Outcome|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
242610|NCT01420289|O2|Outcome|Excercise|Walking on a graded treadmill for 45 minutes once daily
242611|NCT01420289|O1|Outcome|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
242612|NCT01420289|O2|Outcome|Excercise|Walking on a graded treadmill for 45 minutes once daily
242613|NCT01420289|O1|Outcome|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
242614|NCT01420289|E2|Reported Event|Excercise|Walking on a graded treadmill for 45 minutes once daily
242615|NCT01420289|E1|Reported Event|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
242616|NCT01420146|B1|Baseline|Zr89-trastuzumab PET/CT|Zr89-trastuzumab (trastuzumab labelled with zirconium 89) for PET/CT single arm
242617|NCT01420146|P1|Participant Flow|Zr89-trastuzumab PET/CT|Zr89-trastuzumab (trastuzumab labelled with zirconium 89) for PET/CT single arm
242618|NCT01420146|O1|Outcome|Zr89-trastuzumab PET/CT|Zr89-trastuzumab (trastuzumab labelled with zirconium 89) for PET/CT single arm
242619|NCT01420146|E1|Reported Event|Zr89-trastuzumab PET/CT|"Zr89-trastuzumab PET/CT single arm~Zr89-trastuzumab: trastuzumab labelled with zirconium 89 for PET/CT"
242620|NCT01420081|B10|Baseline|Total|Total of all reporting groups
242621|NCT01420081|B9|Baseline|LIC PF-05212384 (154 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 154 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
242622|NCT01420081|B8|Baseline|LIC PF-05212384 (89 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 89 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
242623|NCT01420081|B7|Baseline|Lead-in-cohort (LIC) PF-04691502 (4 mg)|Participants who were enrolled in the PF-04691502 LIC began dosing with PF-04691502 4 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05691502 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
242624|NCT01420081|B6|Baseline|PF-05212384 154 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
242625|NCT01420081|B5|Baseline|PF-05212384 154 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
242626|NCT01420081|B4|Baseline|PF-04691502 6 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
243017|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
242627|NCT01420081|B3|Baseline|PF-04691502 8 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
242628|NCT01420081|B2|Baseline|PF-04691502 6 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
242629|NCT01420081|B1|Baseline|PF-04691502 8 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
242630|NCT01420081|P9|Participant Flow|LIC PF-05212384 (154 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 154 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
242631|NCT01420081|P8|Participant Flow|LIC PF-05212384 (89 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 89 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
242632|NCT01420081|P7|Participant Flow|Lead-in-cohort (LIC) PF-04691502 (4 mg)|Participants who were enrolled in the PF-04691502 LIC began dosing with PF-04691502 4 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05691502 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
242633|NCT01420081|P6|Participant Flow|PF-05212384 154 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
242634|NCT01420081|P5|Participant Flow|PF-05212384 154 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, once weekly (Quaque, QW) until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
242635|NCT01420081|P4|Participant Flow|PF-04691502 6 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
242636|NCT01420081|P3|Participant Flow|PF-04691502 8 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
242637|NCT01420081|P2|Participant Flow|PF-04691502 6 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
242638|NCT01420081|P1|Participant Flow|PF-04691502 8 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 8 mg orally, once daily (QD) until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
242639|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242640|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242641|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242642|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242643|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242644|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242645|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242646|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242647|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242648|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242649|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242650|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242651|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242652|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242653|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242654|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242655|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242656|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242657|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242658|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242659|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242660|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242661|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242662|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242663|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242664|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242665|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242666|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242667|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242668|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242669|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242670|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242671|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242672|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242673|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242674|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242675|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242676|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242677|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242839|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
242678|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242679|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242680|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242681|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242682|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242683|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242684|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242685|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242686|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242687|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242688|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242689|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242690|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242691|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242692|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242693|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242694|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242695|NCT01420081|O2|Outcome|PF-04691502 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
242696|NCT01420081|O1|Outcome|PF-04691502 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
242697|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242698|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242699|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242700|NCT01420081|O2|Outcome|PF-04691502 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
242701|NCT01420081|O1|Outcome|PF-04691502 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
242702|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242703|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242704|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
242840|NCT01419236|E2|Reported Event|Placebo|Placebo solution applied topically once daily for 16 weeks.
242705|NCT01420081|O2|Outcome|PF-04691502 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
242706|NCT01420081|O1|Outcome|PF-04691502 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
242707|NCT01420081|E9|Reported Event|LIC PF-05212384 (154 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 154 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
242708|NCT01420081|E8|Reported Event|LIC PF-05212384 (89 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 89 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
242709|NCT01420081|E7|Reported Event|Lead-in-cohort (LIC) PF-04691502 (4 mg)|Participants who were enrolled in the PF-04691502 LIC began dosing with PF-04691502 4 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05691502 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
242710|NCT01420081|E6|Reported Event|PF-05212384 154 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
242711|NCT01420081|E5|Reported Event|PF-05212384 154 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW (Quaque [Once Weekly]) until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
242712|NCT01420081|E4|Reported Event|PF-04691502 6 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
242713|NCT01420081|E3|Reported Event|PF-04691502 8 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
242714|NCT01420081|E2|Reported Event|PF-04691502 6 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
242715|NCT01420081|E1|Reported Event|PF-04691502 8 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
242716|NCT01419977|B3|Baseline|Total|Total of all reporting groups
242717|NCT01419977|B2|Baseline|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
242718|NCT01419977|B1|Baseline|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
242719|NCT01419977|P2|Participant Flow|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
242720|NCT01419977|P1|Participant Flow|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
242721|NCT01419977|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
242722|NCT01419977|O1|Outcome|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
242723|NCT01419977|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
242724|NCT01419977|O1|Outcome|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
242725|NCT01419977|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
242726|NCT01419977|O1|Outcome|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
242727|NCT01419977|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
242728|NCT01419977|O1|Outcome|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
242729|NCT01419977|E2|Reported Event|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
242730|NCT01419977|E1|Reported Event|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
242731|NCT01419795|B3|Baseline|Total|Total of all reporting groups
242732|NCT01419795|B2|Baseline|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
242806|NCT01419249|P1|Participant Flow|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
242868|NCT01419184|B3|Baseline|Total|Total of all reporting groups
242733|NCT01419795|B1|Baseline|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
242734|NCT01419795|P2|Participant Flow|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
242735|NCT01419795|P1|Participant Flow|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
242736|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
242737|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
242738|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
242739|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
242740|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
242741|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
242742|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
242743|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
242744|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
242745|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
242746|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
245518|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
242747|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
242748|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
242749|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
242750|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
242751|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
242752|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
242753|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
242754|NCT01419795|E2|Reported Event|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
242755|NCT01419795|E1|Reported Event|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
242756|NCT01419769|B1|Baseline|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
242757|NCT01419769|P1|Participant Flow|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
242758|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
243018|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
242759|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
242760|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
242761|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
242762|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
242763|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
242764|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
242765|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
242766|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
242767|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
245572|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
242768|NCT01419769|E1|Reported Event|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
242769|NCT01419639|B1|Baseline|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
242770|NCT01419639|P1|Participant Flow|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
242771|NCT01419639|O1|Outcome|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
242772|NCT01419639|O1|Outcome|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
242773|NCT01419639|O1|Outcome|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
242774|NCT01419639|E1|Reported Event|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
242775|NCT01419314|B3|Baseline|Total|Total of all reporting groups
242776|NCT01419314|B2|Baseline|Splint Liner Application|The liner or protective sheath from the Walkabout™ splint was applied to the LEs, with the structural frame of the splint removed by the researcher in advance.
242777|NCT01419314|B1|Baseline|LE Splints Group|Participants were asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
242778|NCT01419314|P2|Participant Flow|Splint Liner Application|The liner or protective sheath from the Walkabout™ splint will be applied to the LEs, with the structural frame of the splint removed by the researcher in advance.
242779|NCT01419314|P1|Participant Flow|Splinting Application|Participants will be asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
242780|NCT01419314|O2|Outcome|Splint Liner|Night time application of lower extremity splint liner
242781|NCT01419314|O1|Outcome|Lower Extremity Splinting Application|nighttime splint application to the lower extremities
242782|NCT01419314|O2|Outcome|Splint Liner|Night time application of lower extremity splint liner
242783|NCT01419314|O1|Outcome|Lower Extremity Splinting Application|nighttime splint application to the lower extremities
242784|NCT01419314|O2|Outcome|Splint Liner Application|The liner or protective sheath from the Walkabout™ splint will be applied to the LEs, with the structural frame of the splint removed by the researcher in advance, patients will be blinded to this arm of the study.
242785|NCT01419314|O1|Outcome|Splinting Application|Participants will be asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
242786|NCT01419314|O2|Outcome|Splint Liner Application|The liner or protective sheath from the Walkabout™ splint was applied to the LEs, with the structural frame of the splint removed by the researcher in advance.
242787|NCT01419314|O1|Outcome|Splinting Application|Participants were asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
242788|NCT01419314|O2|Outcome|Splint Liner|Night time application of lower extremity splint liner
242789|NCT01419314|O1|Outcome|Lower Extremity Splinting Application|nighttime splint application to the lower extremities
242790|NCT01419314|O2|Outcome|Splint Liner|Night time application of lower extremity splint liner
242791|NCT01419314|O1|Outcome|Lower Extremity Splinting Application|nighttime splint application to the lower extremities
242792|NCT01419314|O2|Outcome|Splint Liner Application|The liner or protective sheath from the Walkabout™ splint was applied to the LEs, with the structural frame of the splint removed by the researcher in advance.
242793|NCT01419314|O1|Outcome|Splinting Application|Participants were asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
242794|NCT01419314|O2|Outcome|Splint Liner|Night time application of lower extremity splint liner
242795|NCT01419314|O1|Outcome|Lower Extremity Splinting Application|nighttime splint application to the lower extremities
242796|NCT01419314|E2|Reported Event|Splint Liner|Night time application of lower extremity splint liner
242797|NCT01419314|E1|Reported Event|Lower Extremity Splinting Application|nighttime splint application to the lower extremities
242798|NCT01419275|B1|Baseline|Moyamoya|Participants with Moyamoya disease received arterial spin label MRI with xenon contrast agent.
242799|NCT01419275|P1|Participant Flow|Moyamoya|Participants with Moyamoya disease received arterial spin label magnetic resonance imaging (MRI) with xenon contrast agent.
242800|NCT01419275|O1|Outcome|Moyamoya|Participants with Moyamoya disease received arterial spin label MRI with xenon contrast agent.
242801|NCT01419275|E1|Reported Event|Moyamoya|Participants with Moyamoya disease received arterial spin label MRI with xenon contrast agent.
242802|NCT01419249|B3|Baseline|Total|Total of all reporting groups
242803|NCT01419249|B2|Baseline|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
242804|NCT01419249|B1|Baseline|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
242805|NCT01419249|P2|Participant Flow|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
242807|NCT01419249|O2|Outcome|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
242808|NCT01419249|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
242809|NCT01419249|O2|Outcome|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
242810|NCT01419249|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
242811|NCT01419249|O1|Outcome|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
242812|NCT01419249|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
242813|NCT01419249|O2|Outcome|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
242814|NCT01419249|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
242815|NCT01419249|E2|Reported Event|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
242816|NCT01419249|E1|Reported Event|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
242817|NCT01419236|B3|Baseline|Total|Total of all reporting groups
242818|NCT01419236|B2|Baseline|Placebo|Placebo solution applied topically once daily for 16 weeks.
242819|NCT01419236|B1|Baseline|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
242820|NCT01419236|P2|Participant Flow|Placebo|Placebo solution applied topically once daily for 16 weeks.
242821|NCT01419236|P1|Participant Flow|Testosterone Solution 2%|Testosterone solution 2% [60 milligrams (mg) applied topically once daily with a potential 1-time titration to 30 milligrams per day (mg/day) or 90 mg/day] for 16 weeks.
242822|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
242823|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
242824|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
242825|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
242826|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
242827|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
242828|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
242829|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
242830|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
242831|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
242832|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
242833|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
242834|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
242835|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
242836|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
242837|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
242838|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
242841|NCT01419236|E1|Reported Event|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
242842|NCT01419197|B3|Baseline|Total|Total of all reporting groups
242843|NCT01419197|B2|Baseline|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
242844|NCT01419197|B1|Baseline|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
242845|NCT01419197|P2|Participant Flow|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and human epidermal growth factor receptor 2 (HER2)-directed therapy.
242846|NCT01419197|P1|Participant Flow|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
242847|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
242848|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
242849|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
242850|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
242851|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
242852|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
242853|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
242854|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
242855|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
242856|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
242857|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
242858|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
242859|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
242860|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
242861|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
242862|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
242863|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
242864|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
242865|NCT01419197|E3|Reported Event|Trastuzumab Emtansine - Post TPC Treatment Switch|Participants, who switched treatment in the Treatment of Physician's Choice arm to trastuzumab emtansine, were administered trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
242866|NCT01419197|E2|Reported Event|Treatment of Physician’s Choice (TPC)|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
242867|NCT01419197|E1|Reported Event|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
242869|NCT01419184|B2|Baseline|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
242870|NCT01419184|B1|Baseline|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
242871|NCT01419184|P2|Participant Flow|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed per investigator’s discretion and was administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occured first. Investigators treated participants according to their usual decision-making and discretion.
242872|NCT01419184|P1|Participant Flow|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for complicated skin and skin structure infections (cSSSI) or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
242873|NCT01419184|O2|Outcome|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
242874|NCT01419184|O1|Outcome|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
242875|NCT01419184|O2|Outcome|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
242876|NCT01419184|O1|Outcome|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
242877|NCT01419184|O2|Outcome|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
242878|NCT01419184|O1|Outcome|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
242879|NCT01419184|O2|Outcome|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
242880|NCT01419184|O1|Outcome|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
242881|NCT01419184|O2|Outcome|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
242882|NCT01419184|O1|Outcome|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
242883|NCT01419184|O2|Outcome|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
242884|NCT01419184|O1|Outcome|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
242885|NCT01419184|E2|Reported Event|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
242886|NCT01419184|E1|Reported Event|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
242887|NCT01419171|B1|Baseline|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
242888|NCT01419171|P1|Participant Flow|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
242889|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
242890|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
242891|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
245697|NCT01405950|O1|Outcome|Dose Level 1|Zanaflex Capsules : 0.025 mg/kg
242892|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
242893|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
242894|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
242895|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
242896|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
242897|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
242898|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
242899|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
242900|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
242901|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
242902|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
242903|NCT01419171|E1|Reported Event|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
242904|NCT01419028|B1|Baseline|Retrospective Observational|Patients with severe perinatal and/or infantile onset HPP (ie, where signs of the disease are present before 6 months of age).
242905|NCT01419028|P1|Participant Flow|Retrospective Observational|Patients with severe perinatal and/or infantile onset HPP (ie, where signs of the disease are present before 6 months of age).
242906|NCT01419028|O1|Outcome|Retrospective Observational|Patients with severe perinatal and/or infantile onset HPP (ie, where signs of the disease are present before 6 months of age).
242907|NCT01419028|O1|Outcome|Retrospective Observational|Patients with severe perinatal and/or infantile onset HPP (ie, where signs of the disease are present before 6 months of age).
242908|NCT01419028|E1|Reported Event|Retrospective Observational|Patients with severe perinatal and/or infantile onset HPP (ie, where signs of the disease are present before 6 months of age).
242909|NCT01418937|B1|Baseline|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
242910|NCT01418937|P1|Participant Flow|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
242911|NCT01418937|O1|Outcome|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
242912|NCT01418937|O1|Outcome|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
242913|NCT01418937|O1|Outcome|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
242914|NCT01418937|O1|Outcome|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
242915|NCT01418937|E1|Reported Event|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
242916|NCT01418703|B3|Baseline|Total|Total of all reporting groups
242917|NCT01418703|B2|Baseline|Enhanced Control to Range (eCTR)|The two modules of the eCTR are the SSM and an enhanced range control module based on an MPC algorithm that aims to maintain glycemia in a target range. eCTR also uses insulin-on-board constraints (29) intended to prevent insulin overdose during intensified therapy. The rationale behind MPC was presented in detail in a recent review (7). Controller aggressiveness was individualized for each subject based on readily available patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery) (30). In this application, the MPC worked using information from the individual’s conventional therapy. Premeal boluses were triggered by the patient, with the carbohydrate amount measured in the CRC kitchen but automatically calculated by eCTR.
242918|NCT01418703|B1|Baseline|Standard Control to Range (sCTR)|The two modules of sCTR are the SSM and a standard range control module that avoids prolonged hyperglycemic excursions. Both modules use a real-time estimate of the patient 's metabolic state based on CGM and insulin infusion data. This estimate is used for prediction of the risks of hypo-and hyperglycemia 30-45 min ahead of the event. If a risk for hypoglycemia is predicted, the SSM attenuates automatically any insulin requests proportionally to the predicted risk level. How aggressively the system attenuates insulin is determined with patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery). If a risk for hyperglycemia is predicted, the range controller gives a correction bolus using the predicted plasma glucose and the patient's CSII parameters; the system injects only half of the computed bolus and can do so once every hour.
242948|NCT01418365|E1|Reported Event|Metronidazole + MMX Placebo|Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally
242949|NCT01418209|B4|Baseline|Total|Total of all reporting groups
245698|NCT01405950|O4|Outcome|Dose Level 4|Zanaflex Capsules: 0.1 mg/kg
242919|NCT01418703|P4|Participant Flow|eCTR Closed-Loop First, Then Open-Loop|"Participants completed open-loop admission, then completed eCTR closed-loop admission.~The two modules of the eCTR are the SSM and an enhanced range control module based on an MPC algorithm that aims to maintain glycemia in a target range. eCTR also uses insulin-on-board constraints (29) intended to prevent insulin overdose during intensified therapy. The rationale behind MPC was presented in detail in a recent review (7). Controller aggressiveness was individualized for each subject based on readily available patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery) (30). In this application, the MPC worked using information from the individual's conventional therapy. Premeal boluses were triggered by the patient, with the carbohydrate amount measured in the CRC kitchen but automatically calculated by eCTR."
242920|NCT01418703|P3|Participant Flow|Open-Loop First, Then eCTR Closed-Loop|"Participants completed open-loop admission, then completed eCTR (Enhanced Control to Range) closed-loop admission.~The two modules of the eCTR are the SSM and an enhanced range control module based on an MPC (model predictive control) algorithm that aims to maintain glycemia in a target range. eCTR also uses insulin-on-board constraints (29) intended to prevent insulin overdose during intensified therapy. The rationale behind MPC was presented in detail in a recent review (7). Controller aggressiveness was individualized for each subject based on readily available patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery) (30). In this application, the MPC worked using information from the individual's conventional therapy. Premeal boluses were triggered by the patient, with the carbohydrate amount measured in the clinical research center (CRC) kitchen but automatically calculated by eCTR."
242921|NCT01418703|P2|Participant Flow|sCTR Closed-Loop First, Then Open-Loop|"Participants completed sCTR Closed-Loop admission, then completed open-loop admission.~The two modules of sCTR are the SSM and a standard range control module that avoids prolonged hyperglycemic excursions. Both modules use a real-time estimate of the patient 's metabolic state based on CGM and insulin infusion data. This estimate is used for prediction of the risks of hypo-and hyperglycemia 30-45 min ahead of the event. If a risk for hypoglycemia is predicted, the SSM attenuates automatically any insulin requests proportionally to the predicted risk level. How aggressively the system attenuates insulin is determined with patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery). If a risk for hyperglycemia is predicted, the range controller gives a correction bolus using the predicted plasma glucose and the patient's CSII parameters; the system injects only half of the computed bolus and can do so once every hour."
242922|NCT01418703|P1|Participant Flow|Open-Loop First, Then sCTR Closed-Loop|"Completed open-loop, then sCTR (Standard Control to Range ) Closed-Loop admission.~The two modules of sCTR are the SSM (safety supervision module) and a standard range control module that avoids prolonged hyperglycemic excursions. Both modules use a real-time estimate of the patient 's metabolic state based on CGM (continuous glucose monitor) and insulin infusion data. This estimate is used for prediction of the risks of hypo-and hyperglycemia 30-45 min ahead of the event. If a risk for hypoglycemia is predicted, the SSM attenuates automatically any insulin requests proportionally to the predicted risk level. How aggressively the system attenuates insulin is determined with patient characteristics (e.g. body weight, insulin-to-carbohydrate ratio, and basal insulin delivery). If a risk for hyperglycemia is predicted, the range controller gives a correction bolus using the predicted plasma glucose and the patient's CSII (continuous subcutaneous insulin infusion) parameters."
242923|NCT01418703|O2|Outcome|Closed Loop|"The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Closed Loop Control (CLC): During the closed-loop admission, the computer used CGM values to make recommendations of insulin treatment based on the algorithms."
242924|NCT01418703|O1|Outcome|Open Loop|"The subject were in charge of their insulin treatment.~Open Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Subjects use their own pump. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...)."
242925|NCT01418703|O2|Outcome|Closed Loop|"The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Closed Loop Control (CLC): During the closed-loop admission, the computer used CGM values to make recommendations of insulin treatment based on the algorithms."
242926|NCT01418703|O1|Outcome|Open Loop|"The subject were in charge of their insulin treatment.~Open Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Subjects use their own pump. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...)."
242950|NCT01418209|B3|Baseline|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
243019|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
243020|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
243021|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
245699|NCT01405950|O3|Outcome|Dose Level 3|Zanaflex Capsules: 0.075 mg/kg
242927|NCT01418703|O2|Outcome|Closed Loop|"The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Closed Loop Control (CLC): During the closed-loop admission, the computer used CGM values to make recommendations of insulin treatment based on the algorithms."
242928|NCT01418703|O1|Outcome|Open Loop|"The subject were in charge of their insulin treatment.~Open Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Subjects use their own pump. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...)."
242929|NCT01418703|E3|Reported Event|eCTR Closed-Loop Control|The two modules of the eCTR are the SSM and an enhanced range control module based on an MPC algorithm that aims to maintain glycemia in a target range. eCTR also uses insulin-on-board constraints (29) intended to prevent insulin overdose during intensified therapy. The rationale behind MPC was presented in detail in a recent review (7). Controller aggressiveness was individualized for each subject based on readily available patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery) (30). In this application, the MPC worked using information from the individual's conventional therapy. Premeal boluses were triggered by the patient, with the carbohydrate amount measured in the CRC kitchen but automatically calculated by eCTR.
242930|NCT01418703|E2|Reported Event|sCTR Closed-Loop Control|The two modules of sCTR are the SSM and a standard range control module that avoids prolonged hyperglycemic excursions. Both modules use a real-time estimate of the patient 's metabolic state based on CGM and insulin infusion data. This estimate is used for prediction of the risks of hypo-and hyperglycemia 30-45 min ahead of the event. If a risk for hypoglycemia is predicted, the SSM attenuates automatically any insulin requests proportionally to the predicted risk level. How aggressively the system attenuates insulin is determined with patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery). If a risk for hyperglycemia is predicted, the range controller gives a correction bolus using the predicted plasma glucose and the patient's CSII parameters; the system injects only half of the computed bolus and can do so once every hour.
242931|NCT01418703|E1|Reported Event|Open-Loop|This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Subjects use their own pump. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...).
242932|NCT01418482|B1|Baseline|Mepilex Border Ag|Mepilex Border Ag, ( a silver dressing)
242933|NCT01418482|P1|Participant Flow|Mepilex Border Ag|Mepilex Border Ag, a silver dressing
242934|NCT01418482|O1|Outcome|Mepilex Border Ag|Mepilex Border Ag
242935|NCT01418482|O1|Outcome|Mepilex Border Ag|Mepilex Border Ag
242936|NCT01418482|O1|Outcome|Mepilex Border Ag|Mepilex Border Ag
242937|NCT01418482|E1|Reported Event|Mepilex Border Ag|Mepilex Border Ag
242938|NCT01418365|B3|Baseline|Total|Total of all reporting groups
242939|NCT01418365|B2|Baseline|Metronidazole + MMX Mesalazine/Mesalamine First|Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, first; then Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally, second
242940|NCT01418365|B1|Baseline|Metronidazole + MMX Placebo First|Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally,first; then Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, second
242941|NCT01418365|P2|Participant Flow|Metronidazole + MMX Mesalazine/Mesalamine First|Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, first; then Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally, second
242942|NCT01418365|P1|Participant Flow|Metronidazole + MMX Placebo First|Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally,first; then Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, second
242943|NCT01418365|O2|Outcome|Metronidazole + MMX Mesalazine/Mesalamine|Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally
242944|NCT01418365|O1|Outcome|Metronidazole + MMX Placebo|Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally
242945|NCT01418365|O2|Outcome|Metronidazole + MMX Mesalazine/Mesalamine|Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally
242946|NCT01418365|O1|Outcome|Metronidazole + MMX Placebo|Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally
242947|NCT01418365|E2|Reported Event|Metronidazole + MMX Mesalazine/Mesalamine|Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally
243012|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
242951|NCT01418209|B2|Baseline|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
242952|NCT01418209|B1|Baseline|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
242953|NCT01418209|P3|Participant Flow|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
242954|NCT01418209|P2|Participant Flow|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
242955|NCT01418209|P1|Participant Flow|Low-dose 17-ß-Estradiol With Progesterone Taper|Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably. The 8 week estradiol treatment is followed 14 days (2 weeks) of progesterone taper (as medroxy-progesterone 10 mg/day).
242956|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
242957|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
242958|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
242959|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
242960|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
242961|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
242962|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
242963|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
242964|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
242965|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
243013|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
243014|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
242966|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
242967|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
242968|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
242969|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
242970|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
242971|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
242972|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
242973|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
242974|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
242975|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
242976|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
242977|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
242978|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
242979|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
242980|NCT01418209|E3|Reported Event|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
243015|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
243016|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
242981|NCT01418209|E2|Reported Event|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
242982|NCT01418209|E1|Reported Event|Low-dose 17-ß-estradiol|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
242983|NCT01418001|B1|Baseline|Level 1: Pazopanib 400 mg QD Gemcitabine and Docetaxel in Com|Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
242984|NCT01418001|P1|Participant Flow|Pazopanib 400 mg QD|Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
242985|NCT01418001|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
242986|NCT01418001|O1|Outcome|Level 1: Pazopanib 400 mg QD|Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
242987|NCT01418001|E1|Reported Event|Level 1: Pazopanib 400 mg QD|Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
242988|NCT01417936|B1|Baseline|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
242989|NCT01417936|P1|Participant Flow|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
242990|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
242991|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
242992|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
242993|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
242994|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
242995|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
242996|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
242997|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
242998|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
242999|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
243000|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
243001|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
243002|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
243003|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
243004|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
243005|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
243006|NCT01417936|E1|Reported Event|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
243007|NCT01417481|B3|Baseline|Total|Total of all reporting groups
243008|NCT01417481|B2|Baseline|Placebo, Then Glycine|"First intervention (8 weeks) with Placebo (sugar glass, 0.5 g/kg/day divided in three doses).~Washout period of 2 weeks. Second intervention (8 weeks) with Glycine (0.5 g/kg/day divided in three doses)."
243009|NCT01417481|B1|Baseline|Glycine, Then Placebo|"First intervention (8 weeks) with Glycine (0.5 g/kg/day divided in three doses).~Washout period of 2 weeks. Second intervention (8 weeks) with Placebo (sugar glass, 0.5 g/kg/day divided in three doses)."
243010|NCT01417481|P2|Participant Flow|Placebo, Then Glycine|"First intervention (8 weeks) with Placebo (sugar glass, 0.5 g/kg/day divided in three doses).~Washout period of 2 weeks. Second intervention (8 weeks) with Glycine (0.5 g/kg/day divided in three doses)."
243011|NCT01417481|P1|Participant Flow|Glycine, Then Placebo|"First intervention (8 weeks) with Glycine (0.5 g/kg/day divided in three doses).~Washout period of 2 weeks. Second intervention (8 weeks) with Placebo (sugar glass, 0.5 g/kg/day divided in three doses)."
245700|NCT01405950|O2|Outcome|Dose Level 2|Zanaflex Capsules : 0.05 mg/kg
243022|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
243023|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
243024|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
243025|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
243026|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
243027|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
243028|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
243029|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
243030|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
243031|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
243032|NCT01417481|E2|Reported Event|Placebo|Patients received a daily oral supplement of sugar glass at a dose of 0.5 g/kg divided in three doses during 8 weeks, dissolved in any liquid.
243033|NCT01417481|E1|Reported Event|Glycine|Patients received a daily oral supplement of glycine at a dose of 0.5 g/kg divided in three doses during 8 weeks, dissolved in any liquid.
243034|NCT01417455|B9|Baseline|Total|Total of all reporting groups
243035|NCT01417455|B8|Baseline|Controls|Healthy donors age and sex matched to the patients
243036|NCT01417455|B7|Baseline|Ankylosing Spondylitis With TNF-blockers|Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
243037|NCT01417455|B6|Baseline|Ankylosing Spondylitis Baseline for TNF Blocker|Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
243038|NCT01417455|B5|Baseline|Ankylosing Spondylitis|Active Ankylosing Spondylitis
243039|NCT01417455|B4|Baseline|Rheumatoid Arthritis With TNF-blockers|RA patients recruited at least 6 months after the start of a TNF-blocker
243040|NCT01417455|B3|Baseline|Rheumatoid Arthritis Baseline for TNF-blockers|RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
243041|NCT01417455|B2|Baseline|Rheumatoid Arthritis With DMARDs|Patients that started DMARD therapy after the Baseline collection
243042|NCT01417455|B1|Baseline|Rheumatoid Arthritis|Active Rheumatoid Arthritis patients
243043|NCT01417455|P8|Participant Flow|Controls|Healthy donors age and sex matched to the patients
243044|NCT01417455|P7|Participant Flow|Ankylosing Spondylitis With TNF-blockers|Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
243045|NCT01417455|P6|Participant Flow|Ankylosing Spondylitis Baseline for TNF Blocker|Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
243046|NCT01417455|P5|Participant Flow|Ankylosing Spondylitis|Active Ankylosing Spondylitis
243047|NCT01417455|P4|Participant Flow|Rheumatoid Arthritis With TNF-blockers|RA patients recruited at least 6 months after the start of a TNF-blocker
243048|NCT01417455|P3|Participant Flow|Rheumatoid Arthritis Baseline for TNF-blockers|RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
243049|NCT01417455|P2|Participant Flow|Rheumatoid Arthritis With DMARDs|Patients that started DMARD therapy after the Baseline collection
243050|NCT01417455|P1|Participant Flow|Rheumatoid Arthritis|Active Rheumatoid Arthritis patients
243051|NCT01417455|O8|Outcome|Controls|Healthy donors age and sex matched to the patients
243052|NCT01417455|O7|Outcome|Ankylosing Spondylitis With TNF-blockers|Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
243053|NCT01417455|O6|Outcome|Ankylosing Spondylitis Baseline for TNF Blocker|Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
243054|NCT01417455|O5|Outcome|Ankylosing Spondylitis|Active Ankylosing Spondylitis
243055|NCT01417455|O4|Outcome|Rheumatoid Arthritis With TNF-blockers|RA patients recruited at least 6 months after the start of a TNF-blocker
243056|NCT01417455|O3|Outcome|Rheumatoid Arthritis Baseline for TNF-blockers|RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
243057|NCT01417455|O2|Outcome|Rheumatoid Arthritis With DMARDs|Patients that started DMARD therapy after the Baseline collection
243058|NCT01417455|O1|Outcome|Rheumatoid Arthritis|Active Rheumatoid Arthritis patients
243059|NCT01417455|O8|Outcome|Controls|Healthy donors age and sex matched to the patients
243060|NCT01417455|O7|Outcome|Ankylosing Spondylitis With TNF-blockers|Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
243061|NCT01417455|O6|Outcome|Ankylosing Spondylitis Baseline for TNF Blocker|Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
243062|NCT01417455|O5|Outcome|Ankylosing Spondylitis|Active Ankylosing Spondylitis
243063|NCT01417455|O4|Outcome|Rheumatoid Arthritis With TNF-blockers|RA patients recruited at least 6 months after the start of a TNF-blocker
243064|NCT01417455|O3|Outcome|Rheumatoid Arthritis Baseline for TNF-blockers|RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
243065|NCT01417455|O2|Outcome|Rheumatoid Arthritis With DMARDs|Patients that started DMARD therapy after the Baseline collection
243066|NCT01417455|O1|Outcome|Rheumatoid Arthritis|Active Rheumatoid Arthritis patients
243067|NCT01417455|E8|Reported Event|Controls|Healthy donors age and sex matched to the patients - Healthy donors were not under any therapy therefore they were not at risk and Adverse effects were not assessed.
243068|NCT01417455|E7|Reported Event|Ankylosing Spondylitis With TNF-blockers|Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
245701|NCT01405950|O1|Outcome|Dose Level 1|Zanaflex Capsules : 0.025 mg/kg
243069|NCT01417455|E6|Reported Event|Ankylosing Spondylitis Baseline for TNF Blocker|Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
243070|NCT01417455|E5|Reported Event|Ankylosing Spondylitis|Active Ankylosing Spondylitis
243071|NCT01417455|E4|Reported Event|Rheumatoid Arthritis With TNF-blockers|RA patients recruited at least 6 months after the start of a TNF-blocker
243072|NCT01417455|E3|Reported Event|Rheumatoid Arthritis Baseline for TNF-blockers|RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
243073|NCT01417455|E2|Reported Event|Rheumatoid Arthritis With DMARDs|Patients that started DMARD therapy after the Baseline collection
243074|NCT01417455|E1|Reported Event|Rheumatoid Arthritis|Active Rheumatoid Arthritis patients
243075|NCT01417377|B1|Baseline|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
243076|NCT01417377|P1|Participant Flow|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
243077|NCT01417377|O1|Outcome|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
243078|NCT01417377|O1|Outcome|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
243079|NCT01417377|O1|Outcome|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
243080|NCT01417377|O1|Outcome|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
243081|NCT01417377|E1|Reported Event|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
243082|NCT01417195|B3|Baseline|Total|Total of all reporting groups
243083|NCT01417195|B2|Baseline|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur and administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
243084|NCT01417195|B1|Baseline|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
243085|NCT01417195|P2|Participant Flow|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
243086|NCT01417195|P1|Participant Flow|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
243087|NCT01417195|O2|Outcome|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur and administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
243088|NCT01417195|O1|Outcome|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
243089|NCT01417195|O2|Outcome|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
243090|NCT01417195|O1|Outcome|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
243091|NCT01417195|O2|Outcome|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur and administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
243092|NCT01417195|O1|Outcome|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
243093|NCT01417195|O2|Outcome|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur and administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
243094|NCT01417195|O1|Outcome|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
243095|NCT01417195|O2|Outcome|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur and administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
243096|NCT01417195|O1|Outcome|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
243097|NCT01417195|O2|Outcome|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
243098|NCT01417195|O1|Outcome|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
243099|NCT01417195|E2|Reported Event|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
243100|NCT01417195|E1|Reported Event|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
243101|NCT01417156|B1|Baseline|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
243102|NCT01417156|P1|Participant Flow|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
243103|NCT01417156|O1|Outcome|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
243104|NCT01417156|O1|Outcome|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
243105|NCT01417156|O1|Outcome|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
243106|NCT01417156|O1|Outcome|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
243107|NCT01417156|O1|Outcome|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
243108|NCT01417156|E1|Reported Event|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
243109|NCT01417104|B3|Baseline|Total|Total of all reporting groups
243110|NCT01417104|B2|Baseline|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
243111|NCT01417104|B1|Baseline|Aliskiren|Aliskiren will be administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
243112|NCT01417104|P2|Participant Flow|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
243113|NCT01417104|P1|Participant Flow|Aliskiren|Aliskiren will be administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
243114|NCT01417104|O2|Outcome|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
243115|NCT01417104|O1|Outcome|Aliskiren|Aliskiren was administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
243116|NCT01417104|O2|Outcome|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
243117|NCT01417104|O1|Outcome|Aliskiren|Aliskiren was administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
243118|NCT01417104|O2|Outcome|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
243119|NCT01417104|O1|Outcome|Aliskiren|Aliskiren was administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
243120|NCT01417104|E2|Reported Event|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
243121|NCT01417104|E1|Reported Event|Aliskiren|Aliskiren was administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
243122|NCT01417078|B1|Baseline|Diazepam Nasal Spray|Diazepam: single-dose; dosage in mg, based on patient body weight
243123|NCT01417078|P1|Participant Flow|Diazepam Nasal Spray|Diazepam: single-dose; dosage in mg, based on patient body weight
243124|NCT01417078|O2|Outcome|Nordiazepam|Diazepam was slowly converted to nordiazepam following intranasal administration.
243125|NCT01417078|O1|Outcome|Diazepam Nasal Spray|Diazepam: single-dose; dosage in mg, based on patient body weight
243126|NCT01417078|O2|Outcome|Nordiazepam|Diazepam was slowly converted to nordiazepam following intranasal administration
243127|NCT01417078|O1|Outcome|Diazepam Nasal Spray|Diazepam: single-dose; dosage in mg, based on patient body weight
243128|NCT01417078|O1|Outcome|Diazepam Nasal Spray|Diazepam: single-dose; dosage in mg, based on patient body weight
243129|NCT01417078|O2|Outcome|Nordiazepam|Diazepam was slowly converted to nordiazepam following intranasal administration
243130|NCT01417078|O1|Outcome|Diazepam Nasal Spray|Diazepam: single-dose; dosage in mg, based on patient body weight
243131|NCT01417078|E1|Reported Event|Diazepam Nasal Spray|Diazepam: single-dose; dosage in mg, based on patient body weight
243132|NCT01417026|B3|Baseline|Total|Total of all reporting groups
243133|NCT01417026|B2|Baseline|Intranasal Placebo|"Intranasal placebo~The placebo is identical to the oxytocin formulation with the exception of the active compound.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.~One dose equals 6 spray puffs (3 puffs in each nostril).~Placebo will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
243134|NCT01417026|B1|Baseline|Intranasal Oxytocin|"Intranasal oxytocin (Trade name: Syntocinon)~Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days.~One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril).~Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
243135|NCT01417026|P2|Participant Flow|Intranasal Placebo|"Intranasal placebo~The placebo is identical to the oxytocin formulation with the exception of the active compound.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.~One dose equals 6 spray puffs (3 puffs in each nostril).~Placebo will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
243136|NCT01417026|P1|Participant Flow|Intranasal Oxytocin|"Intranasal oxytocin (Trade name: Syntocinon)~Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days.~One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril).~Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
243137|NCT01417026|O2|Outcome|Intranasal Placebo|"Intranasal placebo~The placebo is identical to the oxytocin formulation with the exception of the active compound.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.~One dose equals 6 spray puffs (3 puffs in each nostril).~Placebo will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
243138|NCT01417026|O1|Outcome|Intranasal Oxytocin|"Intranasal oxytocin (Trade name: Syntocinon)~Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days.~One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril).~Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
243337|NCT01416142|P2|Participant Flow|Spectacles:PureVision2 HD|Participants crossed over from spectacle wear to PureVision2 HD contact lenses during the movie intermission.
243139|NCT01417026|O2|Outcome|Intranasal Placebo|"Intranasal placebo~The placebo is identical to the oxytocin formulation with the exception of the active compound.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.~One dose equals 6 spray puffs (3 puffs in each nostril).~Placebo will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
243140|NCT01417026|O1|Outcome|Intranasal Oxytocin|"Intranasal oxytocin (Trade name: Syntocinon)~Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days.~One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril).~Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
243141|NCT01417026|O2|Outcome|Intranasal Placebo|"Intranasal placebo~The placebo is identical to the oxytocin formulation with the exception of the active compound.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.~One dose equals 6 spray puffs (3 puffs in each nostril).~Placebo will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
243142|NCT01417026|O1|Outcome|Intranasal Oxytocin|"Intranasal oxytocin (Trade name: Syntocinon)~Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days.~One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril).~Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
243143|NCT01417026|E2|Reported Event|Intranasal Placebo|"Intranasal placebo~The placebo is identical to the oxytocin formulation with the exception of the active compound.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.~One dose equals 6 spray puffs (3 puffs in each nostril).~Placebo will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
243144|NCT01417026|E1|Reported Event|Intranasal Oxytocin|"Intranasal oxytocin (Trade name: Syntocinon)~Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days.~One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril).~Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
243145|NCT01417000|B3|Baseline|Total|Total of all reporting groups
243146|NCT01417000|B2|Baseline|Cy/GVAX|200 mg/m^2 Cy administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1, 4, 7, 10, 13, 16.
243147|NCT01417000|B1|Baseline|Cy/GVAX + CRS-207|200 mg/m^2 Cy administered by IV infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.
243148|NCT01417000|P2|Participant Flow|Cy/GVAX|200 mg/m^2 Cy administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16; GVAX (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1, 4, 7, 10, 13, 16.
243149|NCT01417000|P1|Participant Flow|Cy/GVAX + CRS-207|200 mg per square meter (mg/m^2) cyclophosphamide (Cy) administered by intravenous (IV) infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (GVAX, 5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 colony forming units [CFU]) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.
243150|NCT01417000|O2|Outcome|Cy/GVAX|200 mg/m^2 Cy administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1, 4, 7, 10, 13, 16.
243151|NCT01417000|O1|Outcome|Cy/GVAX + CRS-207|200 mg/m^2 Cy administered by IV infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.
243152|NCT01417000|O2|Outcome|Cy/GVAX|200 mg/m^2 Cy administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1, 4, 7, 10, 13, 16.
243153|NCT01417000|O1|Outcome|Cy/GVAX + CRS-207|200 mg/m^2 Cy administered by IV infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.
243154|NCT01417000|E2|Reported Event|Cy/GVAX|200 mg/m^2 Cy administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1, 4, 7, 10, 13, 16.
243155|NCT01417000|E1|Reported Event|Cy/GVAX + CRS-207|200 mg/m^2 Cy administered by IV infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.
243156|NCT01416610|B1|Baseline|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
243157|NCT01416610|P1|Participant Flow|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
243158|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
243159|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
243160|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
243161|NCT01416610|O4|Outcome|End of Follow-up|End of Follow-up Visit
243162|NCT01416610|O3|Outcome|End of Treatment|End of Treatment Visit
243163|NCT01416610|O2|Outcome|Week 12|Week 12 Visit
243164|NCT01416610|O1|Outcome|Baseline|Baseline Visit
243165|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
243166|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
243167|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
243168|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
243169|NCT01416610|E1|Reported Event|Safety Population|Participants who started treatment
243170|NCT01416584|B4|Baseline|Total|Total of all reporting groups
243171|NCT01416584|B3|Baseline|Methadone & Abstinence Contingency|Participants will only be able to access work if they enroll in the methadone treatment and consistently take their medication, but also will receive a decrease in base pay if they test positive for opiates or cocaine on the drug screens.
243172|NCT01416584|B2|Baseline|Methadone Contingency Group|Participants in this group will only be allowed to work and earn wages as long as they enroll in the methadone treatment and continue to take does of methadone consistently.
243173|NCT01416584|B1|Baseline|Usual Care Control|Participants in this group will be offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They will be offered the methadone treatment but are not required to join in order to gain access to the workplace.
243174|NCT01416584|P3|Participant Flow|Methadone & Abstinence Contingency|Participants were be able to access work if they enroll in the methadone treatment and consistently take their medication, but also received a decrease in base pay if they test positive for opiates or cocaine on the drug screens.
243175|NCT01416584|P2|Participant Flow|Methadone Contingency Group|Participants in this group were allowed to work and earn wages as long as they enrolled in the methadone treatment and continued to take does of methadone consistently.
243176|NCT01416584|P1|Participant Flow|Usual Care Control|Participants in this group were offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They were offered the methadone treatment but are not required to join in order to gain access to the workplace.
243177|NCT01416584|O3|Outcome|Methadone & Abstinence Contingency|Participants were required to stay enrolled in methadone treatment to work and earn wages and provide urine samples negative for opiates and cocaine to maintain maximum pay.
243178|NCT01416584|O2|Outcome|Methadone Contingency Group|Participants were required to stay enrolled in methadone treatment to work and earn wages.
243179|NCT01416584|O1|Outcome|Usual Care Control|Participants could work and earn stipends, but did not have to enter methadone treatment or provide drug-free urine samples to work or earn money.
243180|NCT01416584|O3|Outcome|Methadone & Abstinence Contingency|Participants in this group were able to access work if they enrolled in the methadone treatment and consistently took their medication, but they also received a decrease in base pay if they test positive for opiates or cocaine on the drug screens.
243181|NCT01416584|O2|Outcome|Methadone Contingency Group|Participants in this group were allowed to work and earn wages as long as they enrolled in the methadone treatment and continued to take does of methadone consistently.
243182|NCT01416584|O1|Outcome|Usual Care Control|Participants in this group were offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They were offered the methadone treatment but were not required to join in order to gain access to the workplace.
243183|NCT01416584|O3|Outcome|Methadone & Abstinence Contingency|Participants in this group were able to access work if they enrolled in the methadone treatment and consistently took their medication, but they also received a decrease in base pay if they test positive for opiates or cocaine on the drug screens.
243184|NCT01416584|O2|Outcome|Methadone Contingency Group|Participants in this group were allowed to work and earn wages as long as they enrolled in the methadone treatment and continued to take does of methadone consistently.
243185|NCT01416584|O1|Outcome|Usual Care Control|Participants in this group were offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They were offered the methadone treatment but were not required to join in order to gain access to the workplace.
243186|NCT01416584|O3|Outcome|Methadone & Abstinence Contingency|Participants in this group were able to access work if they enrolled in the methadone treatment and consistently took their medication, but they also received a decrease in base pay if they test positive for opiates or cocaine on the drug screens.
245702|NCT01405950|E2|Reported Event|Dose Level 2|Zanaflex Capsules : 0.05 mg/kg
243187|NCT01416584|O2|Outcome|Methadone Contingency Group|Participants in this group were allowed to work and earn wages as long as they enrolled in the methadone treatment and continued to take does of methadone consistently.
243188|NCT01416584|O1|Outcome|Usual Care Control|Participants in this group were offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They were offered the methadone treatment but were not required to join in order to gain access to the workplace.
243189|NCT01416584|O3|Outcome|Methadone & Abstinence Contingency|Participants in this group were able to access work if they enrolled in the methadone treatment and consistently took their medication, but they also received a decrease in base pay if they test positive for opiates or cocaine on the drug screens.
243190|NCT01416584|O2|Outcome|Methadone Contingency Group|Participants in this group were allowed to work and earn wages as long as they enrolled in the methadone treatment and continued to take does of methadone consistently.
243191|NCT01416584|O1|Outcome|Usual Care Control|Participants in this group were offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They were offered the methadone treatment but were not required to join in order to gain access to the workplace.
243192|NCT01416584|O3|Outcome|Methadone & Abstinence Contingency|Participants in this group were able to access work if they enrolled in the methadone treatment and consistently took their medication, but they also received a decrease in base pay if they test positive for opiates or cocaine on the drug screens.
243193|NCT01416584|O2|Outcome|Methadone Contingency Group|Participants in this group were allowed to work and earn wages as long as they enrolled in the methadone treatment and continued to take does of methadone consistently.
243194|NCT01416584|O1|Outcome|Usual Care Control|Participants in this group were offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They were offered the methadone treatment but were not required to join in order to gain access to the workplace.
243195|NCT01416584|O3|Outcome|Methadone & Abstinence Contingency|Participants in this group were able to access work if they enrolled in the methadone treatment and consistently took their medication, but they also received a decrease in base pay if they test positive for opiates or cocaine on the drug screens.
243196|NCT01416584|O2|Outcome|Methadone Contingency Group|Participants in this group were allowed to work and earn wages as long as they enrolled in the methadone treatment and continued to take does of methadone consistently.
243197|NCT01416584|O1|Outcome|Usual Care Control|Participants in this group were offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They were offered the methadone treatment but were not required to join in order to gain access to the workplace.
243198|NCT01416584|O3|Outcome|Methadone & Abstinence Contingency|Participants in this group were able to access work if they enrolled in the methadone treatment and consistently took their medication, but they also received a decrease in base pay if they test positive for opiates or cocaine on the drug screens.
243199|NCT01416584|O2|Outcome|Methadone Contingency Group|Participants in this group were allowed to work and earn wages as long as they enrolled in the methadone treatment and continued to take does of methadone consistently.
243200|NCT01416584|O1|Outcome|Usual Care Control|Participants in this group were offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They were offered the methadone treatment but were not required to join in order to gain access to the workplace.
243201|NCT01416584|O3|Outcome|Methadone & Abstinence Contingency|Participants will only be able to access work if they enroll in the methadone treatment and consistently take their medication, but also will receive a decrease in base pay if they test positive for opiates or cocaine on the drug screens.
243202|NCT01416584|O2|Outcome|Methadone Contingency Group|Participants in this group will only be allowed to work and earn wages as long as they enroll in the methadone treatment and continue to take does of methadone consistently.
243203|NCT01416584|O1|Outcome|Usual Care Control|Participants in this group will be offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They will be offered the methadone treatment but are not required to join in order to gain access to the workplace.
243204|NCT01416584|O3|Outcome|Methadone & Abstinence Contingency|Participants in this group were able to access work if they enrolled in the methadone treatment and consistently took their medication, but they also received a decrease in base pay if they test positive for opiates or cocaine on the drug screens.
243205|NCT01416584|O2|Outcome|Methadone Contingency Group|Participants in this group were allowed to work and earn wages as long as they enrolled in the methadone treatment and continued to take does of methadone consistently.
243206|NCT01416584|O1|Outcome|Usual Care Control|Participants in this group were offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They were offered the methadone treatment but were not required to join in order to gain access to the workplace.
243207|NCT01416584|E3|Reported Event|Methadone & Abstinence Contingency|Participants will only be able to access work if they enroll in the methadone treatment and consistently take their medication, but also will receive a decrease in base pay if they test positive for opiates or cocaine on the drug screens.
243208|NCT01416584|E2|Reported Event|Methadone Contingency Group|Participants in this group will only be allowed to work and earn wages as long as they enroll in the methadone treatment and continue to take does of methadone consistently.
243209|NCT01416584|E1|Reported Event|Usual Care Control|Participants in this group will be offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They will be offered the methadone treatment but are not required to join in order to gain access to the workplace.
243210|NCT01416571|B1|Baseline|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
243211|NCT01416571|P1|Participant Flow|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
244563|NCT01410565|O1|Outcome|Apaziquone|"Apaziquone: Apaziquone 4 mg in 40 mL diluent~Apaziquone in the Double Blind Phase"
243212|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
243213|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
243214|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
243215|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
243216|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
243217|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
243218|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
243219|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
243220|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
243221|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
243222|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
243223|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
243224|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
243225|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
243226|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
243227|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
243228|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
243229|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
243230|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
243231|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
243232|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
243233|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
243234|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
243235|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
243236|NCT01416571|E1|Reported Event|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
243237|NCT01416389|B3|Baseline|Total|Total of all reporting groups
243238|NCT01416389|B2|Baseline|Ixabepilone|"Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.~Dosage determined by calculating participant's body surface area (40 mg/m^2).~If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met."
243239|NCT01416389|B1|Baseline|LY2523355 + Pegfilgrastim or Filgrastim|"LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day [mg/m^2/day]).~Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.~If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met."
243240|NCT01416389|P2|Participant Flow|Ixabepilone|"Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.~Dosage determined by calculating participant's body surface area (40 mg/m^2).~If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met."
243241|NCT01416389|P1|Participant Flow|LY2523355 + Pegfilgrastim or Filgrastim|"LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day [mg/m^2/day]). One participant was mistakenly dosed with 6 mg/m^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis.~Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.~If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met."
243242|NCT01416389|O1|Outcome|LY2523355|LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day [mg/m^2/day]).
243243|NCT01416389|O1|Outcome|LSN2546307|LSN2546307 is the metabolite of LY2523355. LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day [mg/m^2/day]).
243244|NCT01416389|O2|Outcome|Ixabepilone|"Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.~Dosage determined by calculating participant's body surface area (40 mg/m^2).~If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met."
243245|NCT01416389|O1|Outcome|LY2523355 + Pegfilgrastim or Filgrastim|"LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day [mg/m^2/day]).~Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.~If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met."
243246|NCT01416389|O1|Outcome|LY2523355|LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day [mg/m^2/day]).
243247|NCT01416389|O2|Outcome|Ixabepilone|"Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.~Dosage determined by calculating participant's body surface area (40 mg/m^2).~If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met."
243248|NCT01416389|O1|Outcome|LY2523355 + Pegfilgrastim or Filgrastim|"LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day [mg/m^2/day]).~Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.~If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met."
243249|NCT01416389|O2|Outcome|Ixabepilone|"Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.~Dosage determined by calculating participant's body surface area (40 mg/m^2).~If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met."
243250|NCT01416389|O1|Outcome|LY2523355 + Pegfilgrastim or Filgrastim|"LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day [mg/m^2/day]).~Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.~If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met."
243251|NCT01416389|O2|Outcome|Ixabepilone|"Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.~Dosage determined by calculating participant's body surface area (40 mg/m^2).~If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met."
243275|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243276|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243252|NCT01416389|O1|Outcome|LY2523355 + Pegfilgrastim or Filgrastim|"LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day [mg/m^2/day]).~Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.~If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met."
243253|NCT01416389|O2|Outcome|Ixabepilone|"Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.~Dosage determined by calculating participant's body surface area (40 mg/m^2).~If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met."
243254|NCT01416389|O1|Outcome|LY2523355 + Pegfilgrastim or Filgrastim|"LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day [mg/m^2/day]).~Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.~If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met."
243255|NCT01416389|E2|Reported Event|Ixabepilone|"Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.~Dosage determined by calculating participant's body surface area (40 mg/m^2).~If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met."
243256|NCT01416389|E1|Reported Event|LY2523355 + Pegfilgrastim or Filgrastim|"LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day [mg/m^2/day]). One participant was mistakenly dosed with 6 mg/m^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis.~Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.~If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met."
243257|NCT01416272|B1|Baseline|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care~KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
243258|NCT01416272|P1|Participant Flow|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care~KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
243259|NCT01416272|O1|Outcome|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care~KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
243260|NCT01416272|O1|Outcome|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care~KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
243261|NCT01416272|O1|Outcome|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care~KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
243262|NCT01416272|E1|Reported Event|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care~KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
243263|NCT01416181|B3|Baseline|Total|Total of all reporting groups
243264|NCT01416181|B2|Baseline|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243265|NCT01416181|B1|Baseline|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243266|NCT01416181|P2|Participant Flow|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243267|NCT01416181|P1|Participant Flow|Placebo|Part 1: participants were randomized to receive placebo intravenously (IV) every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243268|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243269|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243270|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243271|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243272|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243273|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243274|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
244564|NCT01410565|O2|Outcome|Placebo|"Placebo~Placebo in the Double Blind Phase"
243277|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243278|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243279|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243280|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243281|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243282|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243283|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243284|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243285|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243286|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243287|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243288|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243289|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243290|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243291|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243292|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243293|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243294|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243295|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243296|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243297|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243298|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243299|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243300|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243301|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243302|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243303|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243304|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
263851|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
243305|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243306|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243307|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243308|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243309|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243310|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243311|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243312|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243313|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243314|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243315|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243316|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243317|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243318|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243319|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243320|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243321|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243322|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243323|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243324|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243325|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243326|NCT01416181|E2|Reported Event|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243327|NCT01416181|E1|Reported Event|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
243328|NCT01416155|B1|Baseline|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
243329|NCT01416155|P1|Participant Flow|Natalizumab|300 mg intravenous (IV) infusions of natalizumab open label every 4 weeks
243330|NCT01416155|O1|Outcome|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
243331|NCT01416155|O1|Outcome|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
243332|NCT01416155|O1|Outcome|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
243333|NCT01416155|O1|Outcome|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
243334|NCT01416155|E1|Reported Event|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
243335|NCT01416142|B1|Baseline|All Eligible Baseline Participants|Participants crossed over from PureVision2 HD contact lenses to spectacle wear during the movie intermission. Following the movie, all subjects were to wear the dispensed contact lenses on a daily wear basis for approximately one week.
243336|NCT01416142|P3|Participant Flow|PureVision2 HD|Following the movie participants wore PureVision2 HD lenses on a daily wear basis for one week.
243338|NCT01416142|P1|Participant Flow|PureVision2 HD:Spectacles|Participants:crossed over from PureVision2 HD contact lenses to spectacle wear during the movie intermission.
243339|NCT01416142|O3|Outcome|No Difference|Participants reporting no difference between the PureVision2 HD lens and spectacles
243340|NCT01416142|O2|Outcome|Spectacles|The subject's habitual spectacles (updated or confirmed as correct within the last 2 years).
243341|NCT01416142|O1|Outcome|PureVision2 Lenses|The currently marketed Bausch + Lomb PureVision2 HD contact lenses. Bausch + Lomb Biotrue® multi-purpose solution was dispensed with the lenses.
243342|NCT01416142|O2|Outcome|Spectacles|The subject's habitual spectacles (updated or confirmed as correct within the last 2 years).
243343|NCT01416142|O1|Outcome|PureVision2 Lenses|The currently marketed Bausch + Lomb PureVision2 HD contact lenses. Bausch + Lomb Biotrue® multi-purpose solution was dispensed with the lenses. The lower the mean logMAR the better the VA.
243344|NCT01416142|E2|Reported Event|Spectacles|The subject's habitual spectacles (updated or confirmed as correct within the last 2 years).
243345|NCT01416142|E1|Reported Event|PureVision2 Lenses|The currently marketed Bausch + Lomb PureVision2 HD contact lenses. Bausch + Lomb Biotrue® multi-purpose solution was dispensed with the lenses.
243346|NCT01416129|B3|Baseline|Total|Total of all reporting groups
243347|NCT01416129|B2|Baseline|Active Comparator: Prosthetic Brimless Socket|This is the experimental socket condition that includes lower trimlines, below the level of the ischial tuberosity.
243348|NCT01416129|B1|Baseline|Active Comparator: Prosthetic Socket Standard of Care|This socket is the standard of care and is defined by higher trimlines and a medial wall that contains the ischial tuberosity.
243349|NCT01416129|P2|Participant Flow|Prosthetic Socket (Experimental): Brimless Socket|5 subjects randomized to the experimental condition then, following assessment, crossed over to accommodate and re-test with the standard of care (ischial containment socket).
243350|NCT01416129|P1|Participant Flow|Standard of Care Prosthetic Socket (Ischial Containment)|In this crossover study, 5 subjects were randomized to continue using their ischial containment socket socket first. After assessment, subjects crossed over into the other condition.
243351|NCT01416129|O2|Outcome|Active Comparator/Experimental: Prosthetic Brimless Socket|
243352|NCT01416129|O1|Outcome|Control Condition: Prosthetic Socket Standard of Care|
243353|NCT01416129|E2|Reported Event|Standard of Care Socket|
243354|NCT01416129|E1|Reported Event|Vacuum Assisted Socket|
243355|NCT01416025|B3|Baseline|Total|Total of all reporting groups
243356|NCT01416025|B2|Baseline|Standard Dosing|Standard doses of voriconazole will be used
243357|NCT01416025|B1|Baseline|Prospective TDM Arm|"Voriconazole dose will be adjusted based on per protocol obtained TDM levels~Prospective TDM Arm: Voriconazole dose will be adjusted based on per protocol obtained TDM levels"
243358|NCT01416025|P2|Participant Flow|Standard Dosing|Standard doses of voriconazole will be used
243359|NCT01416025|P1|Participant Flow|Prospective TDM Arm|"Voriconazole dose will be adjusted based on per protocol obtained TDM levels~Prospective TDM Arm: Voriconazole dose will be adjusted based on per protocol obtained TDM levels"
243360|NCT01416025|O2|Outcome|Standard Dosing|Standard doses of voriconazole will be used
243361|NCT01416025|O1|Outcome|Prospective TDM Arm|"Voriconazole dose will be adjusted based on per protocol obtained TDM levels~Prospective TDM Arm: Voriconazole dose will be adjusted based on per protocol obtained TDM levels"
243362|NCT01416025|E2|Reported Event|Standard Dosing|Standard doses of voriconazole will be used
243363|NCT01416025|E1|Reported Event|Prospective TDM Arm|"Voriconazole dose will be adjusted based on per protocol obtained TDM levels~Prospective TDM Arm: Voriconazole dose will be adjusted based on per protocol obtained TDM levels"
243364|NCT01415986|B1|Baseline|Group 1|Interstitial Photodynamic Therapy (I-PDT)
243365|NCT01415986|P1|Participant Flow|Group 1|Interstitial Photodynamic Therapy (I-PDT). This subject was adminatred with 0.15 mg/kg Foscan on day 1. He was trtaed with I-PDT using 652-nm light at 20 J/cm, 4 days after the drug adminstration. He stayed in a outpatient facility for 3 more days and discharged home.
243366|NCT01415986|O1|Outcome|Group 1|Interstitial Photodynamic Therapy (I-PDT)
243367|NCT01415986|O1|Outcome|Group 1|Interstitial Photodynamic Therapy (PDT)
243368|NCT01415986|E1|Reported Event|Group 1|Interstitial Photodynamic Therapy (I-PDT)
243369|NCT01415960|B1|Baseline|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im injection, twice during the study, three months apart"
243370|NCT01415960|P1|Participant Flow|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im injection, twice during the study, three months apart"
243371|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
243372|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
243373|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
243374|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
243375|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
243376|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
244565|NCT01410565|O1|Outcome|Apaziquone|"Apaziquone: Apaziquone 4 mg in 40 mL diluent~Apaziquone in the Double Blind Phase"
243377|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
243378|NCT01415960|E1|Reported Event|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im injection, twice during the study, three months apart"
243379|NCT01415921|B3|Baseline|Total|Total of all reporting groups
243380|NCT01415921|B2|Baseline|Placebo|"Matching placebo forced titration 15-60 mg as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
243381|NCT01415921|B1|Baseline|Pyridostigmine Bromide|"Forced titration protocol 15-60 mg every 8 hours as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
243382|NCT01415921|P2|Participant Flow|Placebo|"Matching placebo forced titration 15-60 mg as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
243383|NCT01415921|P1|Participant Flow|Pyridostigmine Bromide|"Forced titration protocol 15-60 mg every 8 hours as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
243384|NCT01415921|O2|Outcome|Placebo|"Matching placebo forced titration 15-60 mg as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
243385|NCT01415921|O1|Outcome|Pyridostigmine Bromide|"Forced titration protocol 15-60 mg every 8 hours as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
243386|NCT01415921|O2|Outcome|Placebo|"Matching placebo forced titration 15-60 mg as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
243387|NCT01415921|O1|Outcome|Pyridostigmine Bromide|"Forced titration protocol 15-60 mg every 8 hours as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
243388|NCT01415921|E2|Reported Event|Placebo|"Matching placebo forced titration 15-60 mg as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
243389|NCT01415921|E1|Reported Event|Pyridostigmine Bromide|"Forced titration protocol 15-60 mg every 8 hours as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
243390|NCT01415908|B3|Baseline|Total|Total of all reporting groups
243391|NCT01415908|B2|Baseline|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
243392|NCT01415908|B1|Baseline|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
243393|NCT01415908|P2|Participant Flow|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
243394|NCT01415908|P1|Participant Flow|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
243395|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
243396|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
243397|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
243398|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
243399|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
243400|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
244566|NCT01410565|O2|Outcome|Placebo|"Placebo~Placebo in the Double Blind Phase"
243401|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
243402|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
243403|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
243404|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
243405|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
243406|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
243407|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
243408|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
243409|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
243410|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
243411|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
243412|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
243413|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
243414|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
243415|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
243416|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
243417|NCT01415908|E2|Reported Event|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
243418|NCT01415908|E1|Reported Event|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
243419|NCT01415583|B3|Baseline|Total|Total of all reporting groups
243420|NCT01415583|B2|Baseline|Dexamethasone|Dexamethasone: 0.5mg/kg (max dose 20mg)
243421|NCT01415583|B1|Baseline|Saline|Dexamethasone: 0.5mg/kg (max dose 20mg)
243422|NCT01415583|P2|Participant Flow|Dexamethasone|Dexamethasone: 0.5mg/kg (max dose 20mg)
243423|NCT01415583|P1|Participant Flow|Saline|Dexamethasone: 0.5mg/kg (max dose 20mg)
243424|NCT01415583|O2|Outcome|Dexamethasone|Dexamethasone: 0.5mg/kg (max dose 20mg)
243425|NCT01415583|O1|Outcome|Saline|Dexamethasone: 0.5mg/kg (max dose 20mg)
243426|NCT01415583|E2|Reported Event|Dexamethasone|Dexamethasone: 0.5mg/kg (max dose 20mg)
243427|NCT01415583|E1|Reported Event|Saline|Dexamethasone: 0.5mg/kg (max dose 20mg)
243428|NCT01415531|B3|Baseline|Total|Total of all reporting groups
243429|NCT01415531|B2|Baseline|Nebivolol|Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
243430|NCT01415531|B1|Baseline|Placebo|Dose-matched placebo
243431|NCT01415531|P2|Participant Flow|Nebivolol|Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
243432|NCT01415531|P1|Participant Flow|Placebo|Dose-matched placebo
243433|NCT01415531|O2|Outcome|Nebivolol|Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
243434|NCT01415531|O1|Outcome|Placebo|Dose-matched placebo
243435|NCT01415531|O2|Outcome|Nebivolol|Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
243436|NCT01415531|O1|Outcome|Placebo|Dose-matched placebo
243437|NCT01415531|E2|Reported Event|Nebivolol|Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
243438|NCT01415531|E1|Reported Event|Placebo|Dose-matched placebo
243439|NCT01415518|B3|Baseline|Total|Total of all reporting groups
243440|NCT01415518|B2|Baseline|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243441|NCT01415518|B1|Baseline|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243442|NCT01415518|P2|Participant Flow|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
245703|NCT01405950|E1|Reported Event|Dose Level 1|Zanaflex Capsules : 0.025 mg/kg
243443|NCT01415518|P1|Participant Flow|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243444|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243445|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243446|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243447|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243448|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243449|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243450|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243451|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243452|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243453|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243454|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243455|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243456|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243457|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243458|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243459|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243460|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243461|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243462|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243463|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243464|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243465|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243466|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243467|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243468|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243469|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243470|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243544|NCT01415401|O1|Outcome|AZARGA|Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
245704|NCT01405937|B3|Baseline|Total|Total of all reporting groups
243471|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243472|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243473|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243474|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243475|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243476|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243477|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243478|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243479|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243480|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243481|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243482|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243483|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243484|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243485|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243486|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243487|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243488|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243489|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243490|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243491|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243492|NCT01415518|E2|Reported Event|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243493|NCT01415518|E1|Reported Event|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
243494|NCT01415453|B1|Baseline|Retinitis Pigmentosa|Subject will have retinitis pigmentosa and will be legally blind in one or both eyes
243495|NCT01415453|P1|Participant Flow|Retinitis Pigmentosa|Subject will have retinitis pigmentosa and will be legally blind in one or both eyes
243496|NCT01415453|O1|Outcome|Retinitis Pigmentosa|Subject will have retinitis pigmentosa and will be legally blind in one or both eyes
243497|NCT01415453|E1|Reported Event|Retinitis Pigmentosa|Subject will have retinitis pigmentosa and will be legally blind in one or both eyes
243498|NCT01415427|B5|Baseline|Total|Total of all reporting groups
243499|NCT01415427|B4|Baseline|QW-QW|BMN110 2.0 mg/kg/qw in MOR004 + BMN110 2.0 mg/kg/qw in MOR005
243500|NCT01415427|B3|Baseline|QOW-QOW|BMN110 2.0 mg/kg/qow in MOR004 + BMN110 2.0 mg/kg/qow in MOR005
243501|NCT01415427|B2|Baseline|PBO-QW|Placebo in MOR004 + BMN110 2.0 mg/kg/qw in MOR005
243502|NCT01415427|B1|Baseline|PBO-QOW|Placebo in MOR004 + BMN110 2.0 mg/kg/qow in MOR005
243503|NCT01415427|P4|Participant Flow|QW-QW|Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
244567|NCT01410565|O1|Outcome|Apaziquone|"Apaziquone: Apaziquone 4 mg in 40 mL diluent~Apaziquone in the Double Blind Phase"
243504|NCT01415427|P3|Participant Flow|QOW-QOW|Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
243505|NCT01415427|P2|Participant Flow|PBO-QW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
243506|NCT01415427|P1|Participant Flow|PBO-QOW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
243507|NCT01415427|O5|Outcome|Total|All treatment groups
243508|NCT01415427|O4|Outcome|QW-QW|Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
243509|NCT01415427|O3|Outcome|QOW-QOW|Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
243510|NCT01415427|O2|Outcome|PBO-QW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
243511|NCT01415427|O1|Outcome|PBO-QOW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
243512|NCT01415427|O5|Outcome|Total|All treatment groups
243513|NCT01415427|O4|Outcome|QW-QW|Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
243514|NCT01415427|O3|Outcome|QOW-QOW|Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
243515|NCT01415427|O2|Outcome|PBO-QW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
243516|NCT01415427|O1|Outcome|PBO-QOW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
243517|NCT01415427|O5|Outcome|Total|All treatment groups
243518|NCT01415427|O4|Outcome|QW-QW|Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
243519|NCT01415427|O3|Outcome|QOW-QOW|Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
243520|NCT01415427|O2|Outcome|PBO-QW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
243521|NCT01415427|O1|Outcome|PBO-QOW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
243522|NCT01415427|O5|Outcome|Total|All treatment groups
243523|NCT01415427|O4|Outcome|QW-QW|Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
243524|NCT01415427|O3|Outcome|QOW-QOW|Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
243525|NCT01415427|O2|Outcome|PBO-QW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
243526|NCT01415427|O1|Outcome|PBO-QOW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
243527|NCT01415427|O5|Outcome|Total|All treatment groups
243528|NCT01415427|O4|Outcome|QW-QW|Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
243529|NCT01415427|O3|Outcome|QOW-QOW|Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
243530|NCT01415427|O2|Outcome|PBO-QW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
243531|NCT01415427|O1|Outcome|PBO-QOW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
243532|NCT01415427|O5|Outcome|Total|All treatment groups
243533|NCT01415427|O4|Outcome|QW-QW|Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
243534|NCT01415427|O3|Outcome|QOW-QOW|Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
243535|NCT01415427|O2|Outcome|PBO-QW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
243536|NCT01415427|O1|Outcome|PBO-QOW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
243537|NCT01415427|E5|Reported Event|Total|Total
243538|NCT01415427|E4|Reported Event|QW-QW|QW-QW
243539|NCT01415427|E3|Reported Event|QOW-QOW|QOW-QOW
243540|NCT01415427|E2|Reported Event|PBO-QW|PBO-QW
243541|NCT01415427|E1|Reported Event|PBO-QOW|PBO-QOW
243542|NCT01415401|B1|Baseline|AZARGA|Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
243543|NCT01415401|P1|Participant Flow|AZARGA|Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
243545|NCT01415401|O1|Outcome|AZARGA|Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
243546|NCT01415401|E1|Reported Event|AZARGA|Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
243547|NCT01415349|B1|Baseline|Safety Analysis Set|Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
243548|NCT01415349|P2|Participant Flow|SSP-002358 + Omeprazole First|A single dose of 1 mg SSP-002358 + a single dose of 40 mg Omeprazole in treatment period 1, a washout period, then a single dose of 1 mg SSP-002358 in treatment period 2
243549|NCT01415349|P1|Participant Flow|SSP-002358 First|A single dose of 1 mg SSP-002358 in treatment period 1, a washout period, then a single dose of 1 mg SSP-002358 + a single dose of 40 mg Omeprazole in treatment period 2
243550|NCT01415349|O2|Outcome|SSP-002358 + Omeprazole|All subjects that received SSP-002358 + Omeprazole
243551|NCT01415349|O1|Outcome|SSP-002358 Alone|All subjects that received only SSP-002358
243552|NCT01415349|O2|Outcome|SSP-002358 + Omeprazole|All subjects that received SSP-002358 + Omeprazole
243553|NCT01415349|O1|Outcome|SSP-002358 Alone|All subjects that received only SSP-002358
243554|NCT01415349|E2|Reported Event|SSP-002358 + Omeprazole|All subjects that received SSP-002358 + Omeprazole
243555|NCT01415349|E1|Reported Event|SSP-002358 Alone|All subjects that received only SSP-002358
243556|NCT01415232|B1|Baseline|Ultrasound Measurement|Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth to epidural space in morbidly obese parturients.
243557|NCT01415232|P1|Participant Flow|Ultrasound Measurement|Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth to epidural space in morbidly obese parturients.
243558|NCT01415232|O1|Outcome|Ultrasound Measurement|Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth from the skin to the epidural space in morbidly obese parturients
243559|NCT01415232|E1|Reported Event|Ultrasound Measurement|Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth to epidural space in morbidly obese parturients.
243560|NCT01414855|B1|Baseline|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
243561|NCT01414855|P1|Participant Flow|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy (cyclophosphamide, doxorubicin, vincristine and prednisone) for 6 cycles.
243562|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
243563|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
243564|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
243565|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
243566|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
243567|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
243568|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
243569|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
243570|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
243571|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
243572|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
243573|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
243574|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
243575|NCT01414855|E1|Reported Event|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
243576|NCT01414634|B1|Baseline|ETIMS Dose Escalation|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
243577|NCT01414634|P8|Participant Flow|ETIMS 3x10^9|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
263852|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
243578|NCT01414634|P7|Participant Flow|ETIMS 2.5x10^9|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
243579|NCT01414634|P6|Participant Flow|ETIMS 1x10^9|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
243580|NCT01414634|P5|Participant Flow|ETIMS 5x10^8|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
243581|NCT01414634|P4|Participant Flow|ETIMS 1x10^8|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
243582|NCT01414634|P3|Participant Flow|ETIMS 1x10^7|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
243583|NCT01414634|P2|Participant Flow|ETIMS 1x10^5|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
243584|NCT01414634|P1|Participant Flow|ETIMS 1x10^3|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
243585|NCT01414634|O1|Outcome|ETIMS Dose Escalation|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
243586|NCT01414634|E8|Reported Event|ETIMS 3x10^9|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
243587|NCT01414634|E7|Reported Event|ETIMS 2.5x10^9|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
243588|NCT01414634|E6|Reported Event|ETIMS 1x10^9|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
243589|NCT01414634|E5|Reported Event|ETIMS 5x10^8|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
243590|NCT01414634|E4|Reported Event|ETIMS 1x10^8|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
243591|NCT01414634|E3|Reported Event|ETIMS 1x10^7|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
243592|NCT01414634|E2|Reported Event|ETIMS 1x10^5|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
243593|NCT01414634|E1|Reported Event|ETIMS 1x10^3|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
243594|NCT01414413|B3|Baseline|Total|Total of all reporting groups
243595|NCT01414413|B2|Baseline|Clinic-based ART Assessment and Initiation|8466 adults resident in 3397 households
243596|NCT01414413|B1|Baseline|Home Assessment and Initiation of ART|8194 adults resident in 3213 households
243597|NCT01414413|P2|Participant Flow|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
243598|NCT01414413|P1|Participant Flow|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
243599|NCT01414413|O2|Outcome|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
243600|NCT01414413|O1|Outcome|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
243601|NCT01414413|O2|Outcome|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
243602|NCT01414413|O1|Outcome|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
243603|NCT01414413|O2|Outcome|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
243604|NCT01414413|O1|Outcome|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
243605|NCT01414413|O2|Outcome|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
243606|NCT01414413|O1|Outcome|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
243607|NCT01414413|E2|Reported Event|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
243608|NCT01414413|E1|Reported Event|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
243609|NCT01414244|B3|Baseline|Total|Total of all reporting groups
243610|NCT01414244|B2|Baseline|Placebo|Oral Whey Protein Powder
243611|NCT01414244|B1|Baseline|Glutamine|Oral Glutamine Powder
243612|NCT01414244|P2|Participant Flow|Placebo|Oral Whey Protein Powder
243613|NCT01414244|P1|Participant Flow|Glutamine|Oral Glutamine Powder
243614|NCT01414244|O2|Outcome|Placebo|Oral Whey Protein Powder
243615|NCT01414244|O1|Outcome|Glutamine|Oral Glutamine Powder
243616|NCT01414244|O2|Outcome|Placebo|Oral Whey Protein Powder
243617|NCT01414244|O1|Outcome|Glutamine|Oral Glutamine Powder
243618|NCT01414244|O2|Outcome|Placebo|Oral Whey Protein Powder
243619|NCT01414244|O1|Outcome|Glutamine|Oral Glutamine Powder
243620|NCT01414244|O2|Outcome|Placebo|Oral Whey Protein Powder
243621|NCT01414244|O1|Outcome|Glutamine|Oral Glutamine Powder
243622|NCT01414244|E2|Reported Event|Placebo|Oral Whey Protein Powder
243623|NCT01414244|E1|Reported Event|Glutamine|Oral Glutamine Powder
243624|NCT01414205|B3|Baseline|Total|Total of all reporting groups
243625|NCT01414205|B2|Baseline|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243626|NCT01414205|B1|Baseline|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243627|NCT01414205|P2|Participant Flow|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243628|NCT01414205|P1|Participant Flow|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243629|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
244568|NCT01410565|E2|Reported Event|Placebo|"Placebo~Placebo: Placebo in the Double Blind Phase"
243630|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243631|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243632|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243633|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243634|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243635|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243636|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243637|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243638|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243639|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243640|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243641|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243642|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243643|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243644|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243645|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243646|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243647|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243648|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243649|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243650|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243651|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243652|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243653|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243817|NCT01413958|P2|Participant Flow|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243654|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243655|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243656|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243657|NCT01414205|E2|Reported Event|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243658|NCT01414205|E1|Reported Event|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
243659|NCT01414192|B5|Baseline|Total|Total of all reporting groups
243660|NCT01414192|B4|Baseline|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
243661|NCT01414192|B3|Baseline|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
243662|NCT01414192|B2|Baseline|Ezetimibe Monotherpay With Prior Treatment|Enrolled participants with prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
243663|NCT01414192|B1|Baseline|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
243664|NCT01414192|P4|Participant Flow|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
243665|NCT01414192|P3|Participant Flow|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
243666|NCT01414192|P2|Participant Flow|Ezetimibe Monotherpay With Prior Treatment|Enrolled participants with prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
243667|NCT01414192|P1|Participant Flow|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
243668|NCT01414192|O4|Outcome|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
243669|NCT01414192|O3|Outcome|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
243670|NCT01414192|O2|Outcome|Ezetimibe Monotherapy With Prior Treatment|Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
243671|NCT01414192|O1|Outcome|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
243672|NCT01414192|O4|Outcome|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
243673|NCT01414192|O3|Outcome|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
243674|NCT01414192|O2|Outcome|Ezetimibe Monotherapy With Prior Treatment|Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
243675|NCT01414192|O1|Outcome|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
243676|NCT01414192|O3|Outcome|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
243677|NCT01414192|O2|Outcome|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
243678|NCT01414192|O1|Outcome|Ezetimibe Monotherapy With or Without Prior Treatment|Enrolled participants with or without prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
243679|NCT01414192|O4|Outcome|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
243680|NCT01414192|O3|Outcome|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
243681|NCT01414192|O2|Outcome|Ezetimibe Monotherapy With Prior Treatment|Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
243682|NCT01414192|O1|Outcome|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
243683|NCT01414192|O3|Outcome|Ezetimibe Plus Statin or Ezetimibe/Simvastatin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin or were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
243684|NCT01414192|O2|Outcome|Ezetimibe Monotherapy With Prior Treatment|Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
243685|NCT01414192|O1|Outcome|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
243686|NCT01414192|O4|Outcome|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
243687|NCT01414192|O3|Outcome|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
243688|NCT01414192|O2|Outcome|Ezetimibe Monotherapy With Prior Treatment|Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
243689|NCT01414192|O1|Outcome|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
243690|NCT01414192|E4|Reported Event|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
243691|NCT01414192|E3|Reported Event|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
243692|NCT01414192|E2|Reported Event|Ezetimibe Monotherapy With Prior Treatment|Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
243693|NCT01414192|E1|Reported Event|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
243694|NCT01414166|B3|Baseline|Total|Total of all reporting groups
243695|NCT01414166|B2|Baseline|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
243696|NCT01414166|B1|Baseline|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
243697|NCT01414166|P2|Participant Flow|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
243698|NCT01414166|P1|Participant Flow|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
243699|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
243700|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
243701|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
243702|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
243703|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
243704|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
243705|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
243706|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
243707|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
243708|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
243709|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
243710|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
243711|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
243712|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
243713|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
243714|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
243715|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
243716|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
244949|NCT01409837|B2|Baseline|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
243717|NCT01414166|E2|Reported Event|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
243718|NCT01414166|E1|Reported Event|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
243719|NCT01414153|B5|Baseline|Total|Total of all reporting groups
243720|NCT01414153|B4|Baseline|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
243721|NCT01414153|B3|Baseline|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
243722|NCT01414153|B2|Baseline|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
243723|NCT01414153|B1|Baseline|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
243724|NCT01414153|P4|Participant Flow|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
243725|NCT01414153|P3|Participant Flow|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
243726|NCT01414153|P2|Participant Flow|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
243727|NCT01414153|P1|Participant Flow|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
243728|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
243729|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
243730|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
243731|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
243732|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
243733|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
243734|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
243735|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
243736|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
243737|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
243738|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
243739|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
243740|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
243741|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
243742|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
243743|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
243744|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
243745|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
243746|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
243747|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
243748|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
243749|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
243750|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
243751|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
243752|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
243753|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
243754|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
243755|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
243818|NCT01413958|P1|Participant Flow|Phenylephrine|Phenylephrine hydrochloride, 30 mg extended-release tablets, one tablet every 12 hours for 7 days
243756|NCT01414153|E4|Reported Event|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
243757|NCT01414153|E3|Reported Event|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
243758|NCT01414153|E2|Reported Event|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
243759|NCT01414153|E1|Reported Event|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
243760|NCT01414114|B1|Baseline|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
243761|NCT01414114|P1|Participant Flow|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
243762|NCT01414114|O3|Outcome|Baseline PTH > 700 pg/mL|Participants with baseline PTH > 700 pg/mL
243763|NCT01414114|O2|Outcome|Baseline PTH ≤ 700 pg/mL|Participants with baseline PTH ≤ 700 pg/mL
243764|NCT01414114|O1|Outcome|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
243765|NCT01414114|O3|Outcome|Baseline PTH > 700 pg/mL|Participants with baseline PTH > 700 pg/mL
243766|NCT01414114|O2|Outcome|Baseline PTH ≤ 700 pg/mL|Participants with baseline PTH ≤ 700 pg/mL
243767|NCT01414114|O1|Outcome|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
243768|NCT01414114|O3|Outcome|Baseline PTH > 700 pg/mL|Participants with baseline PTH > 700 pg/mL
243769|NCT01414114|O2|Outcome|Baseline PTH ≤ 700 pg/mL|Participants with baseline PTH ≤ 700 pg/mL
243770|NCT01414114|O1|Outcome|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
243771|NCT01414114|O3|Outcome|Baseline PTH > 700 pg/mL|Participants with baseline PTH > 700 pg/mL
243772|NCT01414114|O2|Outcome|Baseline PTH ≤ 700 pg/mL|Participants with baseline PTH ≤ 700 pg/mL
243773|NCT01414114|O1|Outcome|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
243774|NCT01414114|O3|Outcome|Baseline PTH > 700 pg/mL|Participants with baseline PTH > 700 pg/mL
243775|NCT01414114|O2|Outcome|Baseline PTH ≤ 700 pg/mL|Participants with baseline PTH ≤ 700 pg/mL
243776|NCT01414114|O1|Outcome|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
243777|NCT01414114|E1|Reported Event|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
243778|NCT01414036|B3|Baseline|Total|Total of all reporting groups
243779|NCT01414036|B2|Baseline|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.~Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
243780|NCT01414036|B1|Baseline|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.~Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
243781|NCT01414036|P2|Participant Flow|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.~Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
264001|NCT01348087|O5|Outcome|AFQ056 100mg Bid|
243782|NCT01414036|P1|Participant Flow|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.~Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
243783|NCT01414036|O2|Outcome|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.~Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
243784|NCT01414036|O1|Outcome|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.~Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
243785|NCT01414036|O2|Outcome|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.~Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
243786|NCT01414036|O1|Outcome|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.~Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
243787|NCT01414036|O2|Outcome|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.~Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
243788|NCT01414036|O1|Outcome|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.~Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
243789|NCT01414036|E2|Reported Event|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.~Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
243790|NCT01414036|E1|Reported Event|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.~Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
243791|NCT01414010|B5|Baseline|Total|Total of all reporting groups
243792|NCT01414010|B4|Baseline|Control|Control group, no intervention given.
243793|NCT01414010|B3|Baseline|Antibiotic|Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days
243794|NCT01414010|B2|Baseline|Probiotic|Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days
243795|NCT01414010|B1|Baseline|Prebiotic|Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days
243796|NCT01414010|P4|Participant Flow|Control|Control group, no intervention given.
243797|NCT01414010|P3|Participant Flow|Antibiotic|Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days
243798|NCT01414010|P2|Participant Flow|Probiotic|Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days
243799|NCT01414010|P1|Participant Flow|Prebiotic|Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days
243800|NCT01414010|O10|Outcome|Saccharomyces Boulardii - After Treatment|Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days
243801|NCT01414010|O9|Outcome|Saccharomyces Boulardii - During Treatment|Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days
243802|NCT01414010|O8|Outcome|Saccharomyces Boulardii - Before Treatment|Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days
243803|NCT01414010|O7|Outcome|Trametes Versicolor Extract - After Treatment|Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days
243804|NCT01414010|O6|Outcome|Trametes Versicolor Extract - During Treatment|Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days
243805|NCT01414010|O5|Outcome|Trametes Versicolor Extract - Before Treatment|Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days
243806|NCT01414010|O4|Outcome|Control|Control group - no intervention given.
243807|NCT01414010|O3|Outcome|Amoxicillin - After Treatment|Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days
243808|NCT01414010|O2|Outcome|Amoxicillin - During Treatment|Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days
243809|NCT01414010|O1|Outcome|Amoxicillin - Before Treatment|Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days
243810|NCT01414010|E4|Reported Event|Control|Control group, no intervention given.
243811|NCT01414010|E3|Reported Event|Antibiotic|Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days
243812|NCT01414010|E2|Reported Event|Probiotic|Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days
243813|NCT01414010|E1|Reported Event|Prebiotic|Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days
243814|NCT01413958|B3|Baseline|Total|Total of all reporting groups
243815|NCT01413958|B2|Baseline|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243816|NCT01413958|B1|Baseline|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
244950|NCT01409837|B1|Baseline|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
243819|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243820|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243821|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243822|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243823|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243824|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243825|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243826|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243827|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243828|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243829|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243830|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243831|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243832|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243833|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride 30 mg extended release tablets, one dose every 12 hours for 7 days
243834|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243835|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243836|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243837|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243838|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243839|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243840|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243841|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243842|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243843|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243844|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243845|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243846|NCT01413958|E2|Reported Event|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243847|NCT01413958|E1|Reported Event|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
243848|NCT01413750|B5|Baseline|Total|Total of all reporting groups
243849|NCT01413750|B4|Baseline|Phase II (Placebo)|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
243850|NCT01413750|B3|Baseline|Phase II (Vorinostat)|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
243851|NCT01413750|B2|Baseline|Phase I: Dose Level 2|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
243852|NCT01413750|B1|Baseline|Phase I: Dose Level 1|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 600 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
243853|NCT01413750|P4|Participant Flow|Phase II: Placebo|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to placebo on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
243854|NCT01413750|P3|Participant Flow|Phase II: Vorinostat|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
243855|NCT01413750|P2|Participant Flow|Phase I: Dose Level 2|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
243856|NCT01413750|P1|Participant Flow|Phase I: Dose Level 1|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 600 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
243857|NCT01413750|O1|Outcome|Phase I|All patients enrolled on the Phase I (safety lead-in) portion of the study.
243858|NCT01413750|O2|Outcome|Phase I: Dose Level 2|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
243859|NCT01413750|O1|Outcome|Phase I: Dose Level 1|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 600 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
243860|NCT01413750|O2|Outcome|Phase II: Placebo|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to placebo on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
243861|NCT01413750|O1|Outcome|Phase II: Vorinostat|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
243862|NCT01413750|E4|Reported Event|Phase II: Placebo|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to placebo on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
243863|NCT01413750|E3|Reported Event|Phase II: Vorinostat|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Voninostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
243864|NCT01413750|E2|Reported Event|Phase I: Dose Level 2|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
243865|NCT01413750|E1|Reported Event|Phase I: Dose Level 1|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 600 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
243866|NCT01413542|B3|Baseline|Total|Total of all reporting groups
243867|NCT01413542|B2|Baseline|Group 2|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effect of brain natriuretic peptide and glucagon like receptor-1 (GLP-1) on forearm blood flow and tPA release was studied.
243868|NCT01413542|B1|Baseline|Group 1|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat on forearm blood flow and tPA responses to bradykinin and substance P were studied.
243869|NCT01413542|P4|Participant Flow|Sitagliptin (DPP4 Inhibition) Then Placebo = Group 2|Participants first received Sitagliptin 200 mg then Placebo by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the forearm blood flow and tPA responses to brain natriuretic peptide (BNP) and glucagon-like receptor 1 (GLP-1).
243870|NCT01413542|P3|Participant Flow|Placebo Then Sitagliptin (DPP4 Inhibition)=Group 2|Participants first received Placebo then Sitagliptin 200 mg by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the forearm blood flow and tPA responses to brain natriuretic peptide (BNP) and glucagon-like receptor 1 (GLP-1).
243871|NCT01413542|P2|Participant Flow|Sitagliptin (DPP4 Inhibition) Then Placebo=Group 1|Participants first received Sitagliptin 200 mg then Placebo by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the effect of vehicle and enalaprilat on the forearm blood flow and tPA responses to bradykinin and substance P.
243872|NCT01413542|P1|Participant Flow|Placebo Then Sitagliptin (DPP4 Inhibibition)=Group 1|Participants first received Placebo then Sitagliptin 200 mg by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the effect of vehicle and enalaprilat on the forearm blood flow and tPA responses to bradykinin and substance P.
243873|NCT01413542|O1|Outcome|Group 2|The effect of treatment (placebo vs. DPP4 inhibition) on venous GLP-1 levels during intra-arterial GLP-1 infusion.
243874|NCT01413542|O1|Outcome|Group 1|Participants were randomized to sitagliptin 200 mg (DPP4 inhibitor) vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat (ACE inhibitor) on forearm blood flow and tPA responses to bradykinin (peptide 1) and substance P (SP) (peptide 2) were studied.
243875|NCT01413542|O1|Outcome|Group 1|The effect of ACE and/or DPP4 inhibition on change in heart rate in response to substance P (SP) was evaluated.
243876|NCT01413542|O2|Outcome|Group 1 (Females)|The effect of ACE inhibition and/or DPP4 inhibition on tPA release in response to bradykinin and substance P (SP) was evaluated.
243877|NCT01413542|O1|Outcome|Group 1 (Males)|The effect of ACE inhibition and/or DPP4 inhibition on tPA release in response to bradykinin and substance P (SP) was evaluated.
243878|NCT01413542|O2|Outcome|Group 2|Participants were randomized to sitagliptin 200 mg (DPP4 inhibitor) vs. placebo on each of two study days. On each study day, the effect of study drug on FBF response to glucagon like peptide-1 (peptide 1) and brain natriuretic peptide (peptide 2) was studied.
243879|NCT01413542|O1|Outcome|Group 1|Participants were randomized to sitagliptin 200 mg (DPP4 inhibitor) vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat (ACE inhibitor) on forearm blood flow and tPA responses to bradykinin (peptide 1) and substance P (SP) (peptide 2) were studied.
243880|NCT01413542|E4|Reported Event|Group 2 (Sitagliptin Arm)|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effect of brain natriuretic peptide and glucagon like receptor-1 (GLP-1) on forearm blood flow and tPA release was studied.
243881|NCT01413542|E3|Reported Event|Group 2 (Placebo Arm)|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effect of brain natriuretic peptide and glucagon like receptor-1 (GLP-1) on forearm blood flow and tPA release was studied.
243882|NCT01413542|E2|Reported Event|Group 1 (Sitagliptin Arm)|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat on forearm blood flow and tPA responses to bradykinin and substance P were studied.
243883|NCT01413542|E1|Reported Event|Group 1 (Placebo Arm)|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat on forearm blood flow and tPA responses to bradykinin and substance P were studied.
243884|NCT01413516|B3|Baseline|Total|Total of all reporting groups
243885|NCT01413516|B2|Baseline|Experimental: Varenicline|"Smoking counseling, Varenicline: Experimental~Interventions:~Behavioral: smoking counseling~Drug: varenicline~Smoking counseling: Counseling sessions provided by trained smoking counselor along with varenicline~Varenicline: Varenicline (an approved medication for smoking cessation)"
243886|NCT01413516|B1|Baseline|Control: Sugar Pill Without Any Active Medication|"Smoking counseling, Placebo: Placebo comparator~Interventions:~Behavior: smoking counseling~Drug: placebo (sugar pill without any active medication)~Smoking counseling: Counseling sessions provided by a trained smoking counselor along with placebo during 1st day of study~Placebo: Sugar pill without any active medication"
243887|NCT01413516|P2|Participant Flow|Experimental: Varenicline|"Smoking counseling, Varenicline: Experimental~Interventions:~Behavioral: smoking counseling~Drug: varenicline~Smoking counseling: Counseling sessions provided by trained smoking counselor during 1st day of study along with 28 day supply of varenicline~Varenicline: Varenicline (an approved medication for smoking cessation)"
243888|NCT01413516|P1|Participant Flow|Control: Sugar Pill Without Any Active Medication|"Smoking counseling, Placebo: Placebo comparator~Interventions:~Behavior: smoking counseling~Drug: placebo (sugar pill without any active medication)~Smoking counseling: Counseling sessions provided by a trained smoking counselor during 1st day of study along with 28 day supply of placebo~Placebo: Sugar pill without any active medication"
243889|NCT01413516|O2|Outcome|Experimental: Varenicline|"Smoking counseling, Varenicline: Experimental~Interventions:~Behavioral: smoking counseling~Drug: varenicline~Smoking counseling: Counseling sessions provided by trained smoking counselor along with varenicline~Varenicline: Varenicline (an approved medication for smoking cessation)"
243890|NCT01413516|O1|Outcome|Sugar Pill Without Any Active Medication|"Smoking counseling, Placebo: Placebo comparator~Interventions:~Behavior: smoking counseling~Drug: placebo (sugar pill without any active medication)~Smoking counseling: Counseling sessions provided by a trained smoking counselor along with placebo during 1st day of study~Placebo: Sugar pill without any active medication"
243891|NCT01413516|E2|Reported Event|Experimental: Varenicline|"Smoking counseling, Varenicline: Experimental~Interventions:~Behavioral: smoking counseling~Drug: varenicline~Smoking counseling: Counseling sessions provided by trained smoking counselor during 1st day of study along with 28 day supply of varenicline~Varenicline: Varenicline (an approved medication for smoking cessation)"
243892|NCT01413516|E1|Reported Event|Control: Sugar Pill Without Any Active Medication|"Smoking counseling, Placebo: Placebo comparator~Interventions:~Behavior: smoking counseling~Drug: placebo (sugar pill without any active medication)~Smoking counseling: Counseling sessions provided by a trained smoking counselor during 1st day of study along with 28 day supply of placebo~Placebo: Sugar pill without any active medication"
243893|NCT01413360|B1|Baseline|HD Vitamin C|"High dose vitamin C~High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL"
243894|NCT01413360|P1|Participant Flow|HD Vitamin C|"High dose vitamin C~High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL"
243895|NCT01413360|O1|Outcome|HD Vitamin C|"High dose vitamin C~High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL"
243896|NCT01413360|O1|Outcome|HD Vitamin C|"High dose vitamin C~High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL"
243897|NCT01413360|E1|Reported Event|HD Vitamin C|"High dose vitamin C~High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL"
243898|NCT01413204|B4|Baseline|Total|Total of all reporting groups
243899|NCT01413204|B3|Baseline|Placebo|TA-7284 Placebo, once daily for 24 weeks
243900|NCT01413204|B2|Baseline|TA-7284 High|TA-7284 high dose, once daily for 24 weeks
243901|NCT01413204|B1|Baseline|TA-7284 Low|TA-7284 low dose, once daily for 24 weeks
243902|NCT01413204|P3|Participant Flow|Placebo|TA-7284 Placebo, once daily for 24 weeks
243903|NCT01413204|P2|Participant Flow|TA-7284 High|TA-7284 high dose, once daily for 24 weeks
243904|NCT01413204|P1|Participant Flow|TA-7284 Low|TA-7284 low dose, once daily for 24 weeks
243905|NCT01413204|O3|Outcome|Placebo|TA-7284 Placebo, once daily for 24 weeks
243906|NCT01413204|O2|Outcome|TA-7284 High|TA-7284 high dose, once daily for 24 weeks
243907|NCT01413204|O1|Outcome|TA-7284 Low|TA-7284 low dose, once daily for 24 weeks
243908|NCT01413204|E3|Reported Event|Placebo|TA-7284 Placebo, once daily for 24 weeks
243909|NCT01413204|E2|Reported Event|TA-7284 High|TA-7284 high dose, once daily for 24 weeks
243910|NCT01413204|E1|Reported Event|TA-7284 Low|TA-7284 low dose, once daily for 24 weeks
243911|NCT01413191|B1|Baseline|CixutumumabTreatment|Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
243912|NCT01413191|P1|Participant Flow|CixutumumabTreatment|Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
243913|NCT01413191|O1|Outcome|CixutumumabTreatment|Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
243914|NCT01413191|E1|Reported Event|CixutumumabTreatment|Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
243915|NCT01412983|B1|Baseline|Overall Study|All 99 participants in study
244511|NCT01411137|O1|Outcome|Part 1: Conversion (Baseline)|Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
243916|NCT01412983|P2|Participant Flow|Ciba Vision Soft Contact Lens Then Bausch+Lomb Test Lens|"Ciba Vision Air Optix Aqua soft contact lens~Ciba Vision lens:Bausch+Lomb Test Lens. Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
243917|NCT01412983|P1|Participant Flow|Bausch+Lomb Test Lens Then Ciba Vision Lens|"Bausch+Lomb investigational soft contact lens~Bausch+Lomb Test lens:Ciba Vision Lens. Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
243918|NCT01412983|O2|Outcome|Ciba Vision Soft Contact Lens|"Ciba Vision Air Optix Aqua soft contact lens~Ciba Vision soft contact lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
243919|NCT01412983|O1|Outcome|Bausch + Lomb Test Lens|"Bausch + Lomb investigational soft contact lens~Bausch + Lomb Test lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
243920|NCT01412983|O2|Outcome|Ciba Vision Soft Contact Lens|"Ciba Vision Air Optix Aqua soft contact lens~Ciba Vision soft contact lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
243921|NCT01412983|O1|Outcome|Bausch+Lomb Test Lens|"Bausch+Lomb investigational soft contact lens~Bausch+Lomb Test lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch+Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
243922|NCT01412983|E2|Reported Event|Ciba Vision Soft Contact Lens|"Ciba Vision Air Optix Aqua soft contact lens~Ciba Vision soft contact lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
243923|NCT01412983|E1|Reported Event|Bausch & Lomb Test Lens|"Bausch + Lomb investigational soft contact lens~Bausch & Lomb Test lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
243924|NCT01412957|B3|Baseline|Total|Total of all reporting groups
243925|NCT01412957|B2|Baseline|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
243926|NCT01412957|B1|Baseline|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
243927|NCT01412957|P2|Participant Flow|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
243928|NCT01412957|P1|Participant Flow|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
243929|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
243930|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
243931|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
243932|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
243933|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
243934|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
243935|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
243936|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
243937|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
243938|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
243939|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
243940|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
243941|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
243942|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
243943|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
243944|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
243945|NCT01412957|E2|Reported Event|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
243946|NCT01412957|E1|Reported Event|Panitumumab Plus BSC|
243947|NCT01412944|B3|Baseline|Total|Total of all reporting groups
244554|NCT01410604|E2|Reported Event|Placebo|
243948|NCT01412944|B2|Baseline|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
243949|NCT01412944|B1|Baseline|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
243950|NCT01412944|P6|Participant Flow|AIN457 300 mg - AIN457 10 mg/kg I.V.|
243951|NCT01412944|P5|Participant Flow|AIN457 150 mg - AIN457 10 mg/kg I.V.|
243952|NCT01412944|P4|Participant Flow|AIN457 300 mg - AIN457 300 mg s.c.|
243953|NCT01412944|P3|Participant Flow|I.V. Period: AIN457 150 mg - AIN457 300 mg s.c.|
243954|NCT01412944|P2|Participant Flow|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
243955|NCT01412944|P1|Participant Flow|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
243956|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
243957|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
243958|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
243959|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
243960|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
243961|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
243962|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
243963|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
243964|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
243965|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
243966|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
243967|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
243968|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
243969|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
243970|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
243971|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
243972|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
243973|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
244231|NCT01412333|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
243974|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
243975|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
243976|NCT01412944|E12|Reported Event|Follow-up: AIN457 150 mg - 10 mg/kg i.v.|
243977|NCT01412944|E11|Reported Event|Follow-up: AIN457 150 mg - 300 mg s.c.|
243978|NCT01412944|E10|Reported Event|Follow-up: AIN457 300 mg - 10 mg/kg i.v.|
243979|NCT01412944|E9|Reported Event|Follow up: AIN457 300 mg - AIN457 300 mg s.c.|
243980|NCT01412944|E8|Reported Event|Entire Period: AIN457 300 mg - AIN457 10 mg/kg i.v.|
243981|NCT01412944|E7|Reported Event|Entire Period: AIN457 150 mg - AIN457 10 mg/kg i.v.|
243982|NCT01412944|E6|Reported Event|Entire Period: AIN457 300 mg - AIN457 300 mg s.c.|
243983|NCT01412944|E5|Reported Event|Entire Period: AIN457 150 mg - AIN457 300 mg s.c.|
243984|NCT01412944|E4|Reported Event|I.V. Period: AIN457 300 mg - AIN457 10 mg/kg i.v.|
243985|NCT01412944|E3|Reported Event|I.V. Period: AIN457 150 mg - AIN457 10 mg/kg i.v.|
243986|NCT01412944|E2|Reported Event|I.V. Period: AIN457 300 mg - AIN457 300 mg s.c.|
243987|NCT01412944|E1|Reported Event|I.V. Period: AIN457 150 mg - AIN457 300 mg s.c.|
243988|NCT01412918|B3|Baseline|Total|Total of all reporting groups
243989|NCT01412918|B2|Baseline|No Tinnitus|Individuals without tinnitus.
243990|NCT01412918|B1|Baseline|Tinnitus|"Individual with tinnitus.~The Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device"
243991|NCT01412918|P2|Participant Flow|No Tinnitus|Individuals without tinnitus.
243992|NCT01412918|P1|Participant Flow|Tinnitus|"Individual with tinnitus.~The Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device"
243993|NCT01412918|O2|Outcome|No Tinnitus|Individuals without tinnitus.
243994|NCT01412918|O1|Outcome|Tinnitus|"Individual with tinnitus.~The Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device"
243995|NCT01412918|O1|Outcome|Tinnitus|Tinnitus. genetic sample collection (no intervention)
243996|NCT01412918|E2|Reported Event|No Tinnitus|Individuals without tinnitus.
243997|NCT01412918|E1|Reported Event|Tinnitus|"Individual with tinnitus. Intervention: inhibitor device demonstration.~The Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device"
243998|NCT01412879|B3|Baseline|Total|Total of all reporting groups
243999|NCT01412879|B2|Baseline|Arm 2: R-Bendamustine (Induction Therapy)|R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
244000|NCT01412879|B1|Baseline|Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy)|The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
244001|NCT01412879|P3|Participant Flow|Consolidation Therapy: Stem Cell Transplant|"Patients receive stem cell transplant with non-TBI containing regimen (BCV or BEAM Chemotherapy) for patients 61 years or older or TBI-containing regimen (TBI/VP-16/Cyclophosphamide). BCV chemotherapy: Carmustine IV over 2 hours on days -6 to -4; etoposide IV over 4 hours on day -4; and cyclophosphamide IV over 1 hour on day -2. BEAM chemotherapy: Carmustine IV over 4 hours on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2, and melphalan IV on day -1.~TBI, etoposide, cyclophosphamide: Patients undergo total-body irradiation (TBI)** twice daily on days -8 to -5. Patients also receive etoposide IV on day -4 and cyclophosphamide IV over 1 hour on day -2. * *TBI may not be used for patients 61 years of age and older. Stem cell transplantation: Patients then undergo autologous peripheral blood stem cell transplantation on day 0."
244002|NCT01412879|P2|Participant Flow|Arm 2: R-Bendamustine (Induction Therapy)|R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
244003|NCT01412879|P1|Participant Flow|Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy)|The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
244004|NCT01412879|O2|Outcome|Arm 2: R-Bendamustine (Induction Therapy)|R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
244386|NCT01411696|E1|Reported Event|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
244005|NCT01412879|O1|Outcome|Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy)|The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
244006|NCT01412879|O2|Outcome|Arm 2: R-Bendamustine (Induction Therapy)|R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
244007|NCT01412879|O1|Outcome|Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy)|The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
244008|NCT01412879|O3|Outcome|Stem Cell Transplant (Consolidation Therapy)|"Patients receive stem cell transplant with non-TBI containing regimen (BCV or BEAM Chemotherapy) for patients 61 years or older or TBI-containing regimen (TBI/VP-16/Cyclophosphamide). BCV chemotherapy: Carmustine IV over 2 hours on days -6 to -4; etoposide IV over 4 hours on day -4; and cyclophosphamide IV over 1 hour on day -2. BEAM chemotherapy: Carmustine IV over 4 hours on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2, and melphalan IV on day -1.~TBI, etoposide, cyclophosphamide: Patients undergo total-body irradiation (TBI)** twice daily on days -8 to -5. Patients also receive etoposide IV on day -4 and cyclophosphamide IV over 1 hour on day -2. * *TBI may not be used for patients 61 years of age and older. Stem cell transplantation: Patients then undergo autologous peripheral blood stem cell transplantation on day 0."
244009|NCT01412879|O2|Outcome|R-Bendamustine (Induction Therapy)|R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
244010|NCT01412879|O1|Outcome|R-HCVAD/MTX/Ara-C (Induction Therapy)|The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
244011|NCT01412879|O2|Outcome|Arm 2: R-Bendamustine (Induction Therapy)|R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
244012|NCT01412879|O1|Outcome|Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy)|The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
244013|NCT01412879|E3|Reported Event|Stem Cell Transplant (Consolidation Therapy)|"Patients receive stem cell transplant with non-TBI containing regimen (BCV or BEAM Chemotherapy) for patients 61 years or older or TBI-containing regimen (TBI/VP-16/Cyclophosphamide). BCV chemotherapy: Carmustine IV over 2 hours on days -6 to -4; etoposide IV over 4 hours on day -4; and cyclophosphamide IV over 1 hour on day -2. BEAM chemotherapy: Carmustine IV over 4 hours on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2, and melphalan IV on day -1.~TBI, etoposide, cyclophosphamide: Patients undergo total-body irradiation (TBI)** twice daily on days -8 to -5. Patients also receive etoposide IV on day -4 and cyclophosphamide IV over 1 hour on day -2. * *TBI may not be used for patients 61 years of age and older. Stem cell transplantation: Patients then undergo autologous peripheral blood stem cell transplantation on day 0."
244014|NCT01412879|E2|Reported Event|R-Bendamustine (Induction Therapy)|R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
244045|NCT01412801|O2|Outcome|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
244387|NCT01411592|B3|Baseline|Total|Total of all reporting groups
244555|NCT01410604|E1|Reported Event|Metformin|
244015|NCT01412879|E1|Reported Event|R-HCVAD/MTX/Ara-C (Induction Therapy)|The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
244016|NCT01412801|B7|Baseline|Total|Total of all reporting groups
244017|NCT01412801|B6|Baseline|HIVneg (Infants)|Infants born to HIV-antibody negative maternal subjects
244018|NCT01412801|B5|Baseline|HIVposCD4HIGH (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
244019|NCT01412801|B4|Baseline|HIVposCD4LOW (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL
244020|NCT01412801|B3|Baseline|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
244021|NCT01412801|B2|Baseline|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
244022|NCT01412801|B1|Baseline|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
244023|NCT01412801|P6|Participant Flow|HIVneg(Infants)|Infants born to HIV-antibody negative maternal subjects
244024|NCT01412801|P5|Participant Flow|HIVposCD4HIGH(Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
244025|NCT01412801|P4|Participant Flow|HIVposCD4LOW(Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL .
244026|NCT01412801|P3|Participant Flow|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
244027|NCT01412801|P2|Participant Flow|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
244028|NCT01412801|P1|Participant Flow|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
244029|NCT01412801|O3|Outcome|HIVneg|"Maternal subjects: HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine.~Infants: Infants born to HIV-antibody negative maternal subjects"
244030|NCT01412801|O2|Outcome|HIVposCD4HIGH|Maternal Subjects:HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine Infants:Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
244031|NCT01412801|O1|Outcome|HIVposCD4LOW|Maternal Subjects:HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine Infants:Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL
244032|NCT01412801|O3|Outcome|HIVneg (Infants)|Infants born to HIV-antibody negative maternal subjects
244033|NCT01412801|O2|Outcome|HIVposCD4HIGH (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
244034|NCT01412801|O1|Outcome|HIVposCD4LOW (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL
244035|NCT01412801|O3|Outcome|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
244036|NCT01412801|O2|Outcome|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
244037|NCT01412801|O1|Outcome|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
244038|NCT01412801|O3|Outcome|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
244039|NCT01412801|O2|Outcome|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
244040|NCT01412801|O1|Outcome|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
244041|NCT01412801|O3|Outcome|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
244042|NCT01412801|O2|Outcome|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
244043|NCT01412801|O1|Outcome|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
244044|NCT01412801|O3|Outcome|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine.
244556|NCT01410565|B3|Baseline|Total|Total of all reporting groups
244046|NCT01412801|O1|Outcome|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
244047|NCT01412801|O3|Outcome|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
244048|NCT01412801|O2|Outcome|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
244049|NCT01412801|O1|Outcome|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
244050|NCT01412801|O6|Outcome|HIVneg(Infants)|Infants born to HIV-antibody negative maternal subjects
244051|NCT01412801|O5|Outcome|HIVposCD4HIGH(Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
244052|NCT01412801|O4|Outcome|HIVposCD4LOW(Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL .
244053|NCT01412801|O3|Outcome|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
244054|NCT01412801|O2|Outcome|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
244055|NCT01412801|O1|Outcome|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
244056|NCT01412801|E8|Reported Event|Total Maternal Subjects|Total number of Maternal subjects participated in the study
244057|NCT01412801|E7|Reported Event|HIVneg_Maternal Subjects|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine.
244058|NCT01412801|E6|Reported Event|HIVposCD4HIGH_Maternal Subjects|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/μL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine.
244059|NCT01412801|E5|Reported Event|HIVposCD4LOW_Maternal Subjects|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/μL but > 50 cells/μL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine.
244060|NCT01412801|E4|Reported Event|Total (Infants)|Total number of Infants participated in the study
244061|NCT01412801|E3|Reported Event|HIVneg (Infants)|Infants born to HIV-antibody negative maternal subjects
244062|NCT01412801|E2|Reported Event|HIVposCD4HIGH (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/μL .
244063|NCT01412801|E1|Reported Event|HIVposCD4LOW (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/μL but > 50 cells/μL
244064|NCT01412710|B3|Baseline|Total|Total of all reporting groups
244065|NCT01412710|B2|Baseline|6000 IU Group|This group will be given cholecalciferol 6000 IU once daily, orally for 6 months.
244066|NCT01412710|B1|Baseline|4000 IU Group|This group will be given cholecalciferol 4000 IU once daily, orally for 6 months.
244067|NCT01412710|P2|Participant Flow|6000 IU Group|This group received 6000 IU/day vitamin D3 for 6 months.
244068|NCT01412710|P1|Participant Flow|4000 IU Group|This group received 4000 IU/day vitamin D3 for 6 months.
244069|NCT01412710|O2|Outcome|6000 IU Group|Vitamin D 6000 IU/day
244070|NCT01412710|O1|Outcome|4000 IU Group|Vitamin D 4000 IU/day
244071|NCT01412710|O2|Outcome|6000 IU Group|Vitamin D 6000 IU/day
244072|NCT01412710|O1|Outcome|4000 IU Group|Vitamin D 4000 IU/day
244073|NCT01412710|E2|Reported Event|6000 IU Vitamin D3/Day|This group will be given cholecalciferol 6000 IU once daily, orally for 6 months.
244074|NCT01412710|E1|Reported Event|4000 IU Vitamin D3/Day|This group will be given cholecalciferol 4000 IU once daily, orally for 6 months.
244075|NCT01412541|B3|Baseline|Total|Total of all reporting groups
244076|NCT01412541|B2|Baseline|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244077|NCT01412541|B1|Baseline|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244078|NCT01412541|P2|Participant Flow|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244079|NCT01412541|P1|Participant Flow|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244080|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244081|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244082|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244083|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244084|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244557|NCT01410565|B2|Baseline|Placebo|"Placebo~Placebo in the Double Blind Phase"
244085|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244086|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244087|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244088|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244089|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244090|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244091|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244092|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244093|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244094|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244095|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244096|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244097|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244098|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244099|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244100|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244101|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244102|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244103|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244104|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244105|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244106|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244107|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244108|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244109|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244110|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244111|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244112|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244113|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244114|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
264002|NCT01348087|O4|Outcome|AFQ056 75mg Bid|
244115|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244116|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244117|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244118|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244119|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244120|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244121|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244122|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244123|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244124|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244125|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244126|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244127|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244128|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244129|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244130|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244131|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244132|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244133|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244134|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244135|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244136|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244137|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244138|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244139|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244140|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244141|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244142|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244143|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244144|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
245744|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
244145|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244146|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244147|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244148|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244149|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244150|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244151|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244152|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244153|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244154|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244155|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244156|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244157|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244158|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244159|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244160|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244161|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244162|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244163|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244164|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244165|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244166|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244167|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244168|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244169|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244170|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244171|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244172|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244173|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244174|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
264003|NCT01348087|O3|Outcome|AFQ056 50mg Bid|
244175|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244176|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244177|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244178|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244179|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244180|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244181|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244182|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244183|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244184|NCT01412541|E2|Reported Event|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244185|NCT01412541|E1|Reported Event|Lutonix 035 Drug Coated Balloon (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
244186|NCT01412424|B1|Baseline|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
244187|NCT01412424|P1|Participant Flow|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
244188|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
244189|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
244190|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
244191|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
244192|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
244193|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
244194|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
244195|NCT01412424|O4|Outcome|Octreotide 40, 60, or 80 mg - All Participants|Participants received octreotide 40, 60, or 80 mg orally for up to 13 months.
244196|NCT01412424|O3|Outcome|Octreotide 80 mg|Participants received octreotide 40 mg in the morning and octreotide 40 mg in the evening orally for up to 13 months.
244197|NCT01412424|O2|Outcome|Octreotide 60 mg|Participants received octreotide 40 mg in the morning and octreotide 20 mg in the evening orally for up to 13 months.
244198|NCT01412424|O1|Outcome|Octreotide 40 mg|Participants received octreotide 20 mg orally twice a day for up to 13 months.
244199|NCT01412424|E3|Reported Event|Octreotide 80 mg|Participants received octreotide 40 mg in the morning and octreotide 40 mg in the evening orally for up to 13 months.
244200|NCT01412424|E2|Reported Event|Octreotide 60 mg|Participants received octreotide 40 mg in the morning and octreotide 20 mg in the evening orally for up to 13 months.
244201|NCT01412424|E1|Reported Event|Octreotide 40 mg|Participants received octreotide 20 mg orally twice a day for up to 13 months.
244202|NCT01412333|B3|Baseline|Total|Total of all reporting groups
245745|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
244203|NCT01412333|B2|Baseline|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
244204|NCT01412333|B1|Baseline|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
244205|NCT01412333|P2|Participant Flow|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
244206|NCT01412333|P1|Participant Flow|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
244207|NCT01412333|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
244208|NCT01412333|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
244209|NCT01412333|O1|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
244210|NCT01412333|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
244211|NCT01412333|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
244212|NCT01412333|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
244213|NCT01412333|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
244214|NCT01412333|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
244215|NCT01412333|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
244216|NCT01412333|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
244217|NCT01412333|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
244218|NCT01412333|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
244219|NCT01412333|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
244220|NCT01412333|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
244221|NCT01412333|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
244222|NCT01412333|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
244223|NCT01412333|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
244224|NCT01412333|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
244225|NCT01412333|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
244226|NCT01412333|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
244227|NCT01412333|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
244228|NCT01412333|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
244229|NCT01412333|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
244230|NCT01412333|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
244558|NCT01410565|B1|Baseline|Apaziquone|"Apaziquone 4 mg in 40 mL diluent~Apaziquone in the Double Blind Phase"
244232|NCT01412333|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
244233|NCT01412333|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
244234|NCT01412333|E2|Reported Event|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
244235|NCT01412333|E1|Reported Event|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
244236|NCT01412281|B5|Baseline|Total|Total of all reporting groups
244237|NCT01412281|B4|Baseline|>60 Years - CSL HA Antigen|
244238|NCT01412281|B3|Baseline|>60 Years - AdImmune HA Antigen|
244239|NCT01412281|B2|Baseline|≥18 to ≤60 Years - CSL HA Antigen|
244240|NCT01412281|B1|Baseline|≥18 to ≤60 Years - AdImmune HA Antigen|
244241|NCT01412281|P4|Participant Flow|>60 Years - CSL HA Antigen|
244242|NCT01412281|P3|Participant Flow|>60 Years - AdImmune HA Antigen|
244243|NCT01412281|P2|Participant Flow|≥18 to ≤60 Years - CSL HA Antigen|
244244|NCT01412281|P1|Participant Flow|≥18 to ≤60 Years - AdImmune HA Antigen|
244245|NCT01412281|O4|Outcome|>60 Years - CSL HA Antigen|
244246|NCT01412281|O3|Outcome|>60 Years - AdImmune HA Antigen|
244247|NCT01412281|O2|Outcome|≥18 to ≤60 Years - CSL HA Antigen|
244248|NCT01412281|O1|Outcome|≥18 to ≤60 Years - AdImmune HA Antigen|
244249|NCT01412281|O4|Outcome|>60 Years - CSL HA Antigen|
244250|NCT01412281|O3|Outcome|>60 Years - AdImmune HA Antigen|
244251|NCT01412281|O2|Outcome|≥18 to ≤60 Years - CSL HA Antigen|
244252|NCT01412281|O1|Outcome|≥18 to ≤60 Years - AdImmune HA Antigen|
244253|NCT01412281|O4|Outcome|>60 Years - CSL HA Antigen|
244254|NCT01412281|O3|Outcome|>60 Years - AdImmune HA Antigen|
244255|NCT01412281|O2|Outcome|≥18 to ≤60 Years - CSL HA Antigen|
244256|NCT01412281|O1|Outcome|≥18 to ≤60 Years - AdImmune HA Antigen|
244257|NCT01412281|O4|Outcome|>60 Years - CSL HA Antigen|
244258|NCT01412281|O3|Outcome|>60 Years - AdImmune HA Antigen|
244259|NCT01412281|O2|Outcome|≥18 to ≤60 Years - CSL HA Antigen|
244260|NCT01412281|O1|Outcome|≥18 to ≤60 Years - AdImmune HA Antigen|
244261|NCT01412281|E4|Reported Event|>60 Years - CSL HA Antigen|
244262|NCT01412281|E3|Reported Event|>60 Years - AdImmune HA Antigen|
244263|NCT01412281|E2|Reported Event|≥18 to ≤60 Years - CSL HA Antigen|
244264|NCT01412281|E1|Reported Event|≥18 to ≤60 Years - AdImmune HA Antigen|
244265|NCT01412229|B1|Baseline|Treatment|"nab-paclitaxel 100mg/m2~Carboplatin AUC2 (IV)~Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks~Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.~Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.~Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
244266|NCT01412229|P1|Participant Flow|Treatment|"nab-paclitaxel 100mg/m2~Carboplatin Area under the Curve (AUC2) (IV)~Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks~Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.~Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.~Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
244267|NCT01412229|O1|Outcome|Treatment|"nab-paclitaxel 100mg/m2~Carboplatin AUC2 (IV)~Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks~Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.~Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.~Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
244268|NCT01412229|O1|Outcome|Treatment|"nab-paclitaxel 100mg/m2~Carboplatin AUC2 (IV)~Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks~Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.~Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.~Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
244269|NCT01412229|O1|Outcome|Treatment|"nab-paclitaxel 100mg/m2~Carboplatin AUC2 (IV)~Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks~Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.~Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.~Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
244270|NCT01412229|O1|Outcome|Treatment|"nab-paclitaxel 100mg/m2~Carboplatin AUC2 (IV)~Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks~Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.~Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.~Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
244271|NCT01412229|O1|Outcome|Treatment|"nab-paclitaxel 100mg/m2~Carboplatin AUC2 (IV)~Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks~Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.~Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.~Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
244298|NCT01411995|O1|Outcome|2% Lidocaine Gel|"Women randomized to the Lidocaine arm will receive a total of 3-5cc of 2% gel at the tenaculum site and within the endocervical canal~2% lidocaine gel: 3-5cc of 2% lidocaine gel will be applied to the lip of the cervix and within the endocervical canal prior to IUD insertion"
244272|NCT01412229|O1|Outcome|Treatment|"nab-paclitaxel 100mg/m2~Carboplatin area under curve (AUC)2 (IV)~Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks~Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.~Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.~Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
244273|NCT01412229|O1|Outcome|Treatment|"nab-paclitaxel 100mg/m2~Carboplatin AUC2 (IV)~Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks~Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.~Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.~Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
244274|NCT01412229|O1|Outcome|Treatment|"nab-paclitaxel 100mg/m2~Carboplatin AUC2 (IV)~Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks~Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.~Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.~Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
244275|NCT01412229|O1|Outcome|Treatment|"nab-paclitaxel 100mg/m2~Carboplatin AUC2 (IV)~Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks~Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.~Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.~Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
244276|NCT01412229|E1|Reported Event|Treatment|"nab-paclitaxel 100mg/m2~Carboplatin AUC2 (IV)~Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks~Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.~Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.~Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
244277|NCT01412164|B1|Baseline|Firehawk|"Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD~FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD"
244278|NCT01412164|P1|Participant Flow|Firehawk|"Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD~FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD"
244279|NCT01412164|O1|Outcome|Firehawk|"Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD~FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD"
244280|NCT01412164|E1|Reported Event|Firehawk|"Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD~FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD"
244281|NCT01412151|B1|Baseline|Creatine Monohydrate|Twice daily with a meal mixed in a liquid for a total daily dosage of 30 grams. Daily dosage adjustments (e.g. reductions, suspensions, rechallenges) were allowed to manage adverse events.
244282|NCT01412151|P1|Participant Flow|Creatine Monohydrate|Twice daily with a meal mixed in a liquid for a total daily dosage of 30 grams. Daily dosage adjustments (e.g. reductions, suspensions, rechallenges) were allowed to manage adverse events.
244283|NCT01412151|O1|Outcome|Creatine Monohydrate|Creatine monohydrate: Creatine taken twice daily for a total of 30 grams daily dosage or subject's highest tolerated dose
244284|NCT01412151|O1|Outcome|Creatine Monohydrate|"Creatine monohydrate: Creatine taken twice daily for a total of 30 grams daily dosage or subject's highest tolerated dose.~Data not analyzed."
244285|NCT01412151|O1|Outcome|Creatine Monohydrate|Twice daily with a meal mixed in a liquid for a total daily dosage of 30 grams. Daily dosage adjustments (e.g. reductions, suspensions, rechallenges) were allowed to manage adverse events.
244286|NCT01412151|E1|Reported Event|Creatine Monohydrate|Twice daily with a meal mixed in a liquid for a total daily dosage of 30 grams. Daily dosage adjustments (e.g. reductions, suspensions, rechallenges) were allowed to manage adverse events.
244287|NCT01412086|B1|Baseline|All Participants|Healthy volunteers. No treatment (intervention) was received.
244288|NCT01412086|P1|Participant Flow|All Participants|Healthy volunteers. No treatment (intervention) was received.
244289|NCT01412086|O1|Outcome|All Participants|Healthy volunteers. No treatment (intervention) was received.
244290|NCT01412086|O1|Outcome|All Participants|Healthy volunteers. No treatment (intervention) was received.
244291|NCT01412086|E1|Reported Event|All Participants|Healthy volunteers. No treatment (intervention) was received.
244292|NCT01411995|B3|Baseline|Total|Total of all reporting groups
244293|NCT01411995|B2|Baseline|Water Based Lubricant|"Women randomized to the placebo arm will receive a total of 3-5cc of water based lubricant at the tenaculum site and within the the endocervical canal~Water based lubricant: 3-5cc of water based lubricant will be applied to the lip of the cervix and within the endocervical canal prior to IUD insertion"
244294|NCT01411995|B1|Baseline|2% Lidocaine Gel|"Women randomized to the Lidocaine arm will receive a total of 3-5cc of 2% gel at the tenaculum site and within the endocervical canal~2% lidocaine gel: 3-5cc of 2% lidocaine gel will be applied to the lip of the cervix and within the endocervical canal prior to IUD insertion"
244295|NCT01411995|P2|Participant Flow|Water Based Lubricant|"Women randomized to the placebo arm will receive a total of 3-5cc of water based lubricant at the tenaculum site and within the the endocervical canal~Water based lubricant: 3-5cc of water based lubricant will be applied to the lip of the cervix and within the endocervical canal prior to IUD insertion"
244296|NCT01411995|P1|Participant Flow|2% Lidocaine Gel|"Women randomized to the Lidocaine arm will receive a total of 3-5cc of 2% gel at the tenaculum site and within the endocervical canal~2% lidocaine gel: 3-5cc of 2% lidocaine gel will be applied to the lip of the cervix and within the endocervical canal prior to IUD insertion"
244297|NCT01411995|O2|Outcome|Water Based Lubricant|"Women randomized to the placebo arm will receive a total of 3-5cc of water based lubricant at the tenaculum site and within the the endocervical canal~Water based lubricant: 3-5cc of water based lubricant will be applied to the lip of the cervix and within the endocervical canal prior to IUD insertion"
244325|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
244299|NCT01411995|E2|Reported Event|Water Based Lubricant|"Women randomized to the placebo arm will receive a total of 3-5cc of water based lubricant at the tenaculum site and within the the endocervical canal~Water based lubricant: 3-5cc of water based lubricant will be applied to the lip of the cervix and within the endocervical canal prior to IUD insertion"
244300|NCT01411995|E1|Reported Event|2% Lidocaine Gel|"Women randomized to the Lidocaine arm will receive a total of 3-5cc of 2% gel at the tenaculum site and within the endocervical canal~2% lidocaine gel: 3-5cc of 2% lidocaine gel will be applied to the lip of the cervix and within the endocervical canal prior to IUD insertion"
244301|NCT01411891|B3|Baseline|Total|Total of all reporting groups
244302|NCT01411891|B2|Baseline|Chlorhexidine Impregnated Patch.|Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
244303|NCT01411891|B1|Baseline|Control|Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
244304|NCT01411891|P2|Participant Flow|Chlorhexidine Impregnated Patch.|Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
244305|NCT01411891|P1|Participant Flow|Control|Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
244306|NCT01411891|O2|Outcome|Chlorhexidine Impregnated Patch.|Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
244307|NCT01411891|O1|Outcome|Control|Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
244308|NCT01411891|E2|Reported Event|Chlorhexidine Impregnated Patch.|Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
244309|NCT01411891|E1|Reported Event|Control|Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
244310|NCT01411852|B3|Baseline|Total|Total of all reporting groups
244311|NCT01411852|B2|Baseline|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
244312|NCT01411852|B1|Baseline|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
244313|NCT01411852|P2|Participant Flow|0.9% Sodium Chloride 250 mL Bolus|"0.9% Sodium Chloride 250 mL bolus - A large bore IV will be placed and a 250cc bag of normal saline (NS) will be hung. If IV placement is difficult, NS can be given through an intraosseous line. The procedure will continue until 2 hours after arrival to the hospital or until hemorrhage control is achieved whichever occurs first.~0.9% Sodium Chloride 250 mL bolus: Either systolic blood pressure (SBP) or radial pulse is the endpoint for fluid resuscitation to patients randomized to the experimental group. Patients receive 250 ml bolus of normal saline (NS) only if the SBP is less than 70 mmHg or the radial pulse is not palpable. If the SBP is greater than or equal to 70 mmHg or the radial pulse is palpable, NS is given only to keep the vein open. The study will continue repeating the randomization procedure using only 250 ml bags of NS until 2 hours after arrival to the hospital or until hemorrhage control is achieved whichever occurs first."
244314|NCT01411852|P1|Participant Flow|0.9% Sodium Chloride 2000 mL Bolus|"0.9% Sodium Chloride 2000 mL bolus - An intravenous line (IV) will be placed and a 1000cc bag of normal saline will be hung. If IV placement is difficult, fluid can be given through an intraosseous line. This procedure will continue until either 2 hours after hospital arrival or until control of hemorrhage is achieved whichever occurs first.~0.9% Sodium Chloride 2000 mL bolus: The systolic blood pressure (SBP) is the endpoint for delivering fluid resuscitation to patients randomized to the control group. If the SBP is equal to or less than 90 mmHg, the EMS personnel will start infusing a 1000 ml bolus of normal saline (NS) and will continue using only 1000 ml bags of NS as needed. Once the total fluid reaches 2 liters and the SBP exceeds 110 mmHg, the fluid will be stopped and restarted as necessary to maintain a goal SBP of 110 mmHg."
244315|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
244316|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
244317|NCT01411852|O2|Outcome|Controlled Resuscitation|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
244318|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
244319|NCT01411852|O2|Outcome|Controlled Resuscitation|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
244320|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
244321|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
244322|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
244323|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
244324|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
244326|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
244327|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
244328|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
244329|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
244330|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
244331|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
244332|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
244333|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
244334|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
244335|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
244336|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
244337|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
244338|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
244339|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
244340|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
244341|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
244342|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
244343|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
244344|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
244345|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
244346|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
244347|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
244348|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
244349|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
244350|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
244351|NCT01411852|O3|Outcome|ECV Difference [Standard - Controlled]|ECV treatment difference between SR and CR
244352|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
244353|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
244384|NCT01411696|O1|Outcome|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
244385|NCT01411696|O1|Outcome|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
244354|NCT01411852|E2|Reported Event|Controlled Resuscitation (CR)|"Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.~The total number of patients at risk is one less than the total number of patients enrolled. Regulatory restrictions for prisoners required that no data collection, including severe adverse events, be performed for the patient who was determined to have been in police custody at the time of enrollment."
244355|NCT01411852|E1|Reported Event|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
244356|NCT01411839|B3|Baseline|Total|Total of all reporting groups
244357|NCT01411839|B2|Baseline|Control-Standard Care|Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.
244358|NCT01411839|B1|Baseline|Cognitive-Behavioral Therapy (CBT-AD)|"CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session.~Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions"
244359|NCT01411839|P2|Participant Flow|Control-Standard Care|Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.
244360|NCT01411839|P1|Participant Flow|Cognitive-Behavioral Therapy (CBT-AD)|"CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session.~Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions"
244361|NCT01411839|O2|Outcome|Control-Standard Care|Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.
244362|NCT01411839|O1|Outcome|Cognitive-Behavioral Therapy (CBT-AD)|"CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session.~Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions"
244363|NCT01411839|O2|Outcome|Control-Standard Care|Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.
244364|NCT01411839|O1|Outcome|Cognitive-Behavioral Therapy (CBT-AD)|"CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session.~Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions"
244365|NCT01411839|O2|Outcome|Control-Standard Care|Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.
244366|NCT01411839|O1|Outcome|Cognitive-Behavioral Therapy (CBT-AD)|"CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session.~Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions"
244367|NCT01411839|E2|Reported Event|Control-Standard Care|Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.
244368|NCT01411839|E1|Reported Event|Cognitive-Behavioral Therapy (CBT-AD)|"CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session.~Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions"
244369|NCT01411774|B3|Baseline|Total|Total of all reporting groups
244370|NCT01411774|B2|Baseline|Cognitive-behavioral Therapy Plus D-cycloserine|"This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with d-cycloserine taken 1 hour before the session.~Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.~d-cycloserine: D-cycloserine will be encapsulated into 25mg with identical placebo capsules. Youth will take (1 or 2) DCS or identical placebo capsule 1 hour before sessions 4-10. A 0.7mg/kg dosage corresponds with dosages found to be effective in adult studies (50mg/estimated average adult weight of 70kg=.71mg/kg)."
244371|NCT01411774|B1|Baseline|Cognitive-behavioral Therapy Plus Pill Placebo|"This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with pill placebo taken 1 hour before the session.~Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.~Pill placebo: The pill placebo will be identical to the active study medication in every respect (e.g., size, shape, number of capsules, etc.)."
244372|NCT01411774|P2|Participant Flow|Cognitive-behavioral Therapy Plus D-cycloserine|"This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with d-cycloserine taken 1 hour before the session.~Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.~d-cycloserine: D-cycloserine will be encapsulated into 25mg with identical placebo capsules. Youth will take (1 or 2) DCS or identical placebo capsule 1 hour before sessions 4-10. A 0.7mg/kg dosage corresponds with dosages found to be effective in adult studies (50mg/estimated average adult weight of 70kg=.71mg/kg)."
244373|NCT01411774|P1|Participant Flow|Cognitive-behavioral Therapy Plus Pill Placebo|"This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with pill placebo taken 1 hour before the session.~Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.~Pill placebo: The pill placebo will be identical to the active study medication in every respect (e.g., size, shape, number of capsules, etc.)."
244374|NCT01411774|O2|Outcome|Cognitive-behavioral Therapy Plus D-cycloserine|"This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with d-cycloserine taken 1 hour before the session.~Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.~d-cycloserine: D-cycloserine will be encapsulated into 25mg with identical placebo capsules. Youth will take (1 or 2) DCS or identical placebo capsule 1 hour before sessions 4-10. A 0.7mg/kg dosage corresponds with dosages found to be effective in adult studies (50mg/estimated average adult weight of 70kg=.71mg/kg)."
244375|NCT01411774|O1|Outcome|Cognitive-behavioral Therapy Plus Pill Placebo|"This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with pill placebo taken 1 hour before the session.~Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.~Pill placebo: The pill placebo will be identical to the active study medication in every respect (e.g., size, shape, number of capsules, etc.)."
244376|NCT01411774|O2|Outcome|Cognitive-behavioral Therapy Plus D-cycloserine|"This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with d-cycloserine taken 1 hour before the session.~Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.~d-cycloserine: D-cycloserine will be encapsulated into 25mg with identical placebo capsules. Youth will take (1 or 2) DCS or identical placebo capsule 1 hour before sessions 4-10. A 0.7mg/kg dosage corresponds with dosages found to be effective in adult studies (50mg/estimated average adult weight of 70kg=.71mg/kg)."
244377|NCT01411774|O1|Outcome|Cognitive-behavioral Therapy Plus Pill Placebo|"This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with pill placebo taken 1 hour before the session.~Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.~Pill placebo: The pill placebo will be identical to the active study medication in every respect (e.g., size, shape, number of capsules, etc.)."
244378|NCT01411774|E2|Reported Event|Cognitive-behavioral Therapy Plus D-cycloserine|"This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with d-cycloserine taken 1 hour before the session.~Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.~d-cycloserine: D-cycloserine will be encapsulated into 25mg with identical placebo capsules. Youth will take (1 or 2) DCS or identical placebo capsule 1 hour before sessions 4-10. A 0.7mg/kg dosage corresponds with dosages found to be effective in adult studies (50mg/estimated average adult weight of 70kg=.71mg/kg)."
244379|NCT01411774|E1|Reported Event|Cognitive-behavioral Therapy Plus Pill Placebo|"This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with pill placebo taken 1 hour before the session.~Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.~Pill placebo: The pill placebo will be identical to the active study medication in every respect (e.g., size, shape, number of capsules, etc.)."
244380|NCT01411696|B1|Baseline|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
244381|NCT01411696|P1|Participant Flow|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
244382|NCT01411696|O1|Outcome|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
244383|NCT01411696|O1|Outcome|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
244559|NCT01410565|P3|Participant Flow|Open Label-Apaziquone|
244388|NCT01411592|B2|Baseline|Panavia 21 TC|"16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Patients were recalled after 6 and 12 months, and then annually."
244389|NCT01411592|B1|Baseline|Multilink|"14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer).~Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).~Patients were recalled after 6 and 12 months, and then annually."
244390|NCT01411592|P2|Participant Flow|Panavia 21 TC|"16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Patients were recalled after 6 and 12 months, and then annually."
244391|NCT01411592|P1|Participant Flow|Multilink|"14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer).~Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).~Patients were recalled after 6 and 12 months, and then annually."
244392|NCT01411592|O2|Outcome|Panavia 21 TC|"16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Patients were recalled after 6 and 12 months, and then annually."
244393|NCT01411592|O1|Outcome|Multilink|"14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer).~Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).~Patients were recalled after 6 and 12 months, and then annually."
244394|NCT01411592|O2|Outcome|Panavia 21 TC|"16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Patients were recalled after 6 and 12 months, and then annually."
244395|NCT01411592|O1|Outcome|Multilink|"14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer).~Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).~Patients were recalled after 6 and 12 months, and then annually."
244396|NCT01411592|E2|Reported Event|Panavia 21 TC|"16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Patients were recalled after 6 and 12 months, and then annually."
244397|NCT01411592|E1|Reported Event|Multilink|"14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer).~Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).~Patients were recalled after 6 and 12 months, and then annually."
244398|NCT01411501|B5|Baseline|Total|Total of all reporting groups
244399|NCT01411501|B4|Baseline|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
244400|NCT01411501|B3|Baseline|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244401|NCT01411501|B2|Baseline|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244402|NCT01411501|B1|Baseline|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244403|NCT01411501|P4|Participant Flow|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
244404|NCT01411501|P3|Participant Flow|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244405|NCT01411501|P2|Participant Flow|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244406|NCT01411501|P1|Participant Flow|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244407|NCT01411501|O4|Outcome|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
244408|NCT01411501|O3|Outcome|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244409|NCT01411501|O2|Outcome|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244410|NCT01411501|O1|Outcome|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244411|NCT01411501|O4|Outcome|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
244412|NCT01411501|O3|Outcome|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244471|NCT01411215|B1|Baseline|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244560|NCT01410565|P2|Participant Flow|Placebo|"Placebo~Placebo: Placebo in the Double Blind Phase"
244413|NCT01411501|O2|Outcome|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244414|NCT01411501|O1|Outcome|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244415|NCT01411501|O4|Outcome|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
244416|NCT01411501|O3|Outcome|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244417|NCT01411501|O2|Outcome|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244418|NCT01411501|O1|Outcome|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244419|NCT01411501|O4|Outcome|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
244420|NCT01411501|O3|Outcome|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244421|NCT01411501|O2|Outcome|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244422|NCT01411501|O1|Outcome|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244423|NCT01411501|O4|Outcome|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
244472|NCT01411215|P2|Participant Flow|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244473|NCT01411215|P1|Participant Flow|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244424|NCT01411501|O3|Outcome|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244425|NCT01411501|O2|Outcome|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244426|NCT01411501|O1|Outcome|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244427|NCT01411501|O4|Outcome|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
244428|NCT01411501|O3|Outcome|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244429|NCT01411501|O2|Outcome|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244430|NCT01411501|O1|Outcome|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244431|NCT01411501|E4|Reported Event|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
244432|NCT01411501|E3|Reported Event|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244433|NCT01411501|E2|Reported Event|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244474|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244475|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244561|NCT01410565|P1|Participant Flow|Apaziquone|"Apaziquone: Apaziquone 4 mg in 40 mL diluent~Apaziquone: Apaziquone in the Double Blind Phase"
244434|NCT01411501|E1|Reported Event|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
244435|NCT01411488|B3|Baseline|Total|Total of all reporting groups
244436|NCT01411488|B2|Baseline|Fecal Management System- Company 2|"38 adult patients to be randomly assigned to receive a fecal management system by ConvaTec~Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions~45% male; 39.1% had history of hemorrhoids"
244437|NCT01411488|B1|Baseline|Fecal Management System- Company 1|"41 adult patients to be randomly assigned to receive a fecal management system by Bard Medical~Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions~55% male; 60% had history of hemorrhoids"
244438|NCT01411488|P2|Participant Flow|Fecal Management System- Company 2|"43 adult patients to be randomly assigned to receive a fecal management system by ConvaTec~Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions~Note: not all patients were retained"
244439|NCT01411488|P1|Participant Flow|Fecal Management System- Company 1|"47 adult patients to be randomly assigned to receive a fecal management system by Bard Medical~Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions~Note, not all patients were retained"
244440|NCT01411488|O2|Outcome|Fecal Management System- Company 2|"38 adult patients to be randomly assigned to receive a fecal management system by ConvaTec~Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions"
244441|NCT01411488|O1|Outcome|Fecal Management System- Company 1|"41 adult patients to be randomly assigned to receive a fecal management system by Bard Medical~Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions"
244442|NCT01411488|E2|Reported Event|Fecal Management System- Company 2|"38 adult patients to be randomly assigned to receive a fecal management system by ConvaTec~Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions"
244443|NCT01411488|E1|Reported Event|Fecal Management System- Company 1|"41 adult patients to be randomly assigned to receive a fecal management system by Bard Medical~Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions"
244444|NCT01411228|B4|Baseline|Total|Total of all reporting groups
244445|NCT01411228|B3|Baseline|Dose Adjusted|Taliglucerase alfa: Dose increased from 30 Units/kg to 45 or 60 Units/kg
244446|NCT01411228|B2|Baseline|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
244447|NCT01411228|B1|Baseline|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
244448|NCT01411228|P3|Participant Flow|Switchover|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
244449|NCT01411228|P2|Participant Flow|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
244450|NCT01411228|P1|Participant Flow|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
244451|NCT01411228|O3|Outcome|Switchover|Taliglucerase alfa: Maintained dose from PB-06-002 study
244452|NCT01411228|O2|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
244453|NCT01411228|O1|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
244454|NCT01411228|O3|Outcome|Switchover|Taliglucerase alfa: Maintained dose from PB-06-002 study
244455|NCT01411228|O2|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
244456|NCT01411228|O1|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
244457|NCT01411228|O3|Outcome|Switchover|Taliglucerase alfa: Maintained dose from PB-06-002 study
244458|NCT01411228|O2|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
244459|NCT01411228|O1|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
244460|NCT01411228|O3|Outcome|Switchover|Taliglucerase alfa: Maintained dose from PB-06-002 study
244461|NCT01411228|O2|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
244462|NCT01411228|O1|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
244463|NCT01411228|O3|Outcome|Switchover|Taliglucerase alfa: Maintained dose from PB-06-002 study
244464|NCT01411228|O2|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
244465|NCT01411228|O1|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
244466|NCT01411228|E3|Reported Event|Switchover|Taliglucerase alfa: Maintained dose from PB-06-002 study
244467|NCT01411228|E2|Reported Event|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
244468|NCT01411228|E1|Reported Event|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
244469|NCT01411215|B3|Baseline|Total|Total of all reporting groups
244470|NCT01411215|B2|Baseline|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244510|NCT01411137|O2|Outcome|Part 1: Conversion (Week 6)|Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
244476|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244477|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244478|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244479|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244480|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244481|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244482|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244483|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244484|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244485|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244486|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244487|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244488|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244489|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244490|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244491|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244492|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244493|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244494|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244495|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244496|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244497|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244498|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244499|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244500|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244501|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244502|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244503|NCT01411215|E2|Reported Event|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244504|NCT01411215|E1|Reported Event|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
244505|NCT01411137|B1|Baseline|All Study Participants|"Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.~Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.~Following the successful completion of Part 2 of the study, eligible subjects could participate in Part 3, an additional 6-month open-label extension study."
244506|NCT01411137|P1|Participant Flow|IPX066|extended-release CD-LD
244507|NCT01411137|O5|Outcome|Part 1 or 2 Early Termination|"Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.~Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study."
244508|NCT01411137|O4|Outcome|Part 2: Open-Label Extension (Month 6)|Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
244509|NCT01411137|O3|Outcome|Part 2: Open-Label Extension (Month 3)|Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
244562|NCT01410565|O2|Outcome|Placebo|"Placebo~Placebo in the Double Blind Phase"
244512|NCT01411137|O4|Outcome|Part 1 or 2 Early Termination|"Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.~Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study."
244513|NCT01411137|O3|Outcome|Part 2: Open-Label Extension (Month 6)|Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
244514|NCT01411137|O2|Outcome|Part 2: Open-Label Extension (Month 3)|Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
244515|NCT01411137|O1|Outcome|Part 1: Conversion|Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
244516|NCT01411137|O4|Outcome|Part 1 or 2 Early Termination|"Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.~Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study."
244517|NCT01411137|O3|Outcome|Part 2: Open-Label Extension (Month 6)|Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
244518|NCT01411137|O2|Outcome|Part 2: Open-Label Extension (Month 3)|Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
244519|NCT01411137|O1|Outcome|Part 1: Conversion|Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
244520|NCT01411137|E4|Reported Event|Overall|All treated subjects
244521|NCT01411137|E3|Reported Event|Part 3: Open-Label Extension 2|Following the successful completion of Part 2 of the study, eligible subjects could participate in Part 3, a 6-month open-label extension study.
244522|NCT01411137|E2|Reported Event|Part 2: Open-Label Extension 1|Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
244523|NCT01411137|E1|Reported Event|Part 1: Conversion|Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
244524|NCT01411085|B1|Baseline|Risperidone + Desipramine|All participants were treated with risperidone (or risperidone-like agent, including risperidone long-acting, paliperidone or paliperidone palmitate) at the time treatment with desipramine was initiated. The target dose of oral risperidone was 4 mg/day, though variations were allowed. The target dose of desipramine was 100 mg/day.
244525|NCT01411085|P1|Participant Flow|Risperidone + Desipramine|All participants were treated with risperidone (or risperidone-like agent, including risperidone long-acting, paliperidone and paliperidone palmitate) at the time that treatment with desipramine was initiated. The target of oral risperidone was 4 mg/day, though variations were allowed. The target dose of desipramine was 100 mg/day.
244526|NCT01411085|O1|Outcome|Risperidone + Desipramine|All participants were treated with risperidone (or a risperidone-like agent, including risperidone long-acting, paliperidone or paliperidone palmitate). The target dose of oral risperidone was 4 mg/day, though variations were allowed. The target dose of desipramine was 100 mg/day.
244527|NCT01411085|E1|Reported Event|Risperidone + Desipramine|"All participants were treated with risperidone (or a risperidone-like agent including: risperidone long-acting, paliperdione, and paliperidone palmitate) at the time treatment with desipramine is initiated. The target dose of oral risperidone is 4mg/day though variations were allowed. The target dose of desipramine was 100mg/day.~Risperidone + Desipramine"
244528|NCT01410773|B1|Baseline|Intended Users of the System|"Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.~Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor."
244529|NCT01410773|P1|Participant Flow|Intended Users of the System|"Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.~Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor."
244530|NCT01410773|O1|Outcome|Intended Users of the System|"Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.~Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor."
244531|NCT01410773|O1|Outcome|Intended Users of the System|"Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.~Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor."
244532|NCT01410773|E1|Reported Event|Intended Users of the System|"Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.~Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor."
244533|NCT01410604|B3|Baseline|Total|Total of all reporting groups
244534|NCT01410604|B2|Baseline|Placebo|
244535|NCT01410604|B1|Baseline|Metformin|
244536|NCT01410604|P2|Participant Flow|Placebo|
244537|NCT01410604|P1|Participant Flow|Metformin|
244538|NCT01410604|O2|Outcome|Placebo|
244539|NCT01410604|O1|Outcome|Metformin|
244540|NCT01410604|O2|Outcome|Placebo|
244541|NCT01410604|O1|Outcome|Metformin|
244542|NCT01410604|O2|Outcome|Placebo|
244543|NCT01410604|O1|Outcome|Metformin|
244544|NCT01410604|O2|Outcome|Placebo|
244545|NCT01410604|O1|Outcome|Metformin|
244546|NCT01410604|O2|Outcome|Placebo|
244547|NCT01410604|O1|Outcome|Metformin|
244548|NCT01410604|O2|Outcome|Placebo|
244549|NCT01410604|O1|Outcome|Metformin|
244550|NCT01410604|O2|Outcome|Placebo|
244551|NCT01410604|O1|Outcome|Metformin|
244552|NCT01410604|O2|Outcome|Placebo|
244553|NCT01410604|O1|Outcome|Metformin|
244569|NCT01410565|E1|Reported Event|Apaziquone|"Apaziquone: Apaziquone 4 mg in 40 mL diluent~Apaziquone: Apaziquone in the Double Blind Phase"
244570|NCT01410552|B1|Baseline|Single Arm|ICD or CRT-D with PARAD+
244571|NCT01410552|P1|Participant Flow|ICD or CRT-D With PARAD+|"only 1 arm is the study: all patients implanted with ICD or CRT-D with PARAD+ enabled, no comparator~PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770: PARADYM ICD and CRT-d with PARAD+ algorithm available"
244572|NCT01410552|O1|Outcome|Single Arm|ICD or CRT-D with PARAD+
244573|NCT01410552|O1|Outcome|Single Arm|ICD or CRT-D with PARAD+
244574|NCT01410552|E1|Reported Event|ICD or CRT-D With PARAD+|"only 1 arm is the study: all patients implanted with ICD or CRT-D with PARAD+ enabled, no comparator~PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770: PARADYM ICD and CRT-d with PARAD+ algorithm available"
244575|NCT01410474|B3|Baseline|Total|Total of all reporting groups
244576|NCT01410474|B2|Baseline|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
244577|NCT01410474|B1|Baseline|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
244578|NCT01410474|P2|Participant Flow|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
244579|NCT01410474|P1|Participant Flow|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
244580|NCT01410474|O3|Outcome|Overall (6-18 Years)|Subjects 6-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1
244581|NCT01410474|O2|Outcome|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1
244582|NCT01410474|O1|Outcome|6-10 Years|Subjects 6-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1
244583|NCT01410474|O1|Outcome|2-5 Years|Subjects 2-5 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1
244584|NCT01410474|O3|Outcome|Overall (2 to 18 Years)|Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
244585|NCT01410474|O2|Outcome|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
244586|NCT01410474|O1|Outcome|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
244587|NCT01410474|O3|Outcome|Overall (2 to 18 Years)|Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
244588|NCT01410474|O2|Outcome|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
244589|NCT01410474|O1|Outcome|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
244590|NCT01410474|O3|Outcome|Overall (2 to 18 Years)|Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
244591|NCT01410474|O2|Outcome|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
244592|NCT01410474|O1|Outcome|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
244593|NCT01410474|O2|Outcome|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
244594|NCT01410474|O1|Outcome|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
244595|NCT01410474|O1|Outcome|Overall (2 to 18 Years)|Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
244596|NCT01410474|E3|Reported Event|Overall (2 to 18 Years)|Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
244597|NCT01410474|E2|Reported Event|11–18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
244598|NCT01410474|E1|Reported Event|2–10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
244599|NCT01410448|B3|Baseline|Total|Total of all reporting groups
244600|NCT01410448|B2|Baseline|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
244601|NCT01410448|B1|Baseline|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
244602|NCT01410448|P2|Participant Flow|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
244603|NCT01410448|P1|Participant Flow|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
244604|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
244605|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
244951|NCT01409837|P2|Participant Flow|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill taken once daily. Then crossed over to Lisinopril 2.5 mg taken once a day.
244606|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
244607|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
244608|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
244609|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
244610|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
244611|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
244612|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
244613|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
244614|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
244615|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
244616|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
244617|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
244618|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
244619|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
244620|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
244621|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
244622|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
244623|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
244624|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
244625|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
244626|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
244627|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
244628|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
244629|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
264004|NCT01348087|O2|Outcome|AFQ056 25mg Bid|
244630|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
244631|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
244632|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
244633|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
244634|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
244635|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
244636|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
244637|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
244638|NCT01410448|E2|Reported Event|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
244639|NCT01410448|E1|Reported Event|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
244640|NCT01410409|B3|Baseline|Total|Total of all reporting groups
244641|NCT01410409|B2|Baseline|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
244642|NCT01410409|B1|Baseline|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
244643|NCT01410409|P2|Participant Flow|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
244644|NCT01410409|P1|Participant Flow|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
244673|NCT01410357|O1|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244645|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
244646|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
244647|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
244648|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
244649|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
244650|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
244651|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
244652|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
244674|NCT01410357|O2|Outcome|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244742|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244653|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
244654|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
244655|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
244656|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
244657|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
244658|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
244659|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
244660|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
244737|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244738|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
264005|NCT01348087|O1|Outcome|Prior to Ext First Dose|
244661|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
244662|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
244663|NCT01410409|E2|Reported Event|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
244664|NCT01410409|E1|Reported Event|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
244665|NCT01410357|B3|Baseline|Total|Total of all reporting groups
244666|NCT01410357|B2|Baseline|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244667|NCT01410357|B1|Baseline|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244668|NCT01410357|P2|Participant Flow|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244669|NCT01410357|P1|Participant Flow|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM (diabetes mellitus) and SMI (serious mental illness) from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244670|NCT01410357|O2|Outcome|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244671|NCT01410357|O1|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244672|NCT01410357|O2|Outcome|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244739|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244740|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
264006|NCT01348087|E6|Reported Event|AFQ056 Total|
244675|NCT01410357|O1|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244676|NCT01410357|O2|Outcome|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244677|NCT01410357|O1|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244678|NCT01410357|O2|Outcome|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244679|NCT01410357|O1|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244680|NCT01410357|O2|Outcome|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244681|NCT01410357|O1|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244682|NCT01410357|O2|Outcome|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244683|NCT01410357|O1|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244684|NCT01410357|O2|Outcome|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244685|NCT01410357|O1|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244686|NCT01410357|O2|Outcome|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244687|NCT01410357|O1|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244688|NCT01410357|O2|Outcome|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244741|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244743|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244689|NCT01410357|O1|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244690|NCT01410357|O2|Outcome|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244691|NCT01410357|O1|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244692|NCT01410357|O2|Outcome|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244693|NCT01410357|O1|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244694|NCT01410357|O2|Outcome|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244695|NCT01410357|O1|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244696|NCT01410357|O2|Outcome|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244697|NCT01410357|O1|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244698|NCT01410357|O2|Outcome|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244699|NCT01410357|O1|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244700|NCT01410357|O2|Outcome|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244701|NCT01410357|O1|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244702|NCT01410357|O2|Outcome|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244772|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
245155|NCT01408719|B5|Baseline|Sequence 5|3g HMW, followed by 3g LMW, followed by control, followed by 5g LMW
244703|NCT01410357|O1|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244704|NCT01410357|O2|Outcome|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244705|NCT01410357|O1|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244706|NCT01410357|O2|Outcome|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244707|NCT01410357|O1|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244708|NCT01410357|O2|Outcome|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244709|NCT01410357|O1|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244710|NCT01410357|O2|Outcome|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244711|NCT01410357|O1|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244712|NCT01410357|O2|Outcome|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244713|NCT01410357|O1|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244714|NCT01410357|O2|Outcome|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244715|NCT01410357|O1|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244716|NCT01410357|O2|Outcome|Treatment As Usual (TAU)|Participants in this arm will continue to receive Treatment as Usual from their usual medical and mental health care providers. They will not receive any intervention.
244870|NCT01410227|O1|Outcome|Full Analysis Set|Comprised of participants treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) for whom at least one efficacy rating scale was available.
244717|NCT01410357|O1|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm will receive the TTIM intervention as well as receiving regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blends psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, has been adapted to the primary care setting and targeted for SMI-DM participants. Generalizability is enhanced with relatively brief in-person participation requirements and by utilizing professional staff typically found in primary care. TTIM will stress information sharing that is accessible to participants, and through a collaborative process, foster motivation for SMI-DM self-management."
244718|NCT01410357|O2|Outcome|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244719|NCT01410357|O1|Outcome|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244720|NCT01410357|E2|Reported Event|Treatment As Usual (TAU)|Participants in this arm received Treatment as Usual from their usual medical and mental health care providers. They did not receive any intervention.
244721|NCT01410357|E1|Reported Event|Targeted Training in Illness Management (TTIM)|"Participants in this arm received the TTIM intervention as well as regular treatment for their DM and SMI from their normal medical and mental health care providers.~Targeted Training in Illness Management (TTIM): This intervention blended psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, and was adapted to the primary care setting and targeted SMI-DM participants. Generalizability was enhanced with relatively brief in-person participation requirements and professional staff typically found in primary care were utilized. TTIM stressed information sharing that is accessible to participants, and through a collaborative process, fostered motivation for SMI-DM self-management."
244722|NCT01410344|B1|Baseline|Allogeneic Transplant|One regimen from either reduced-intensity conditioning (RIC) (Fludarabine and Busulfan; or Fludarabine and Melphalan) or myeloablative conditioning (MAC) (Busulfan and Fludarabine; or Cyclophosphamide and Total Body Irradiation) will be administered prior to allogeneic hematopoietic cell transplantation (HCT).
244723|NCT01410344|P1|Participant Flow|Allogeneic Transplant|One regimen from either reduced-intensity conditioning (RIC) (Fludarabine and Busulfan; or Fludarabine and Melphalan) or myeloablative conditioning (MAC) (Busulfan and Fludarabine; or Cyclophosphamide and Total Body Irradiation) will be administered prior to allogeneic hematopoietic cell transplantation (HCT).
244724|NCT01410344|O1|Outcome|Allogeneic Transplant|One regimen from either reduced-intensity conditioning (RIC) (Fludarabine and Busulfan; or Fludarabine and Melphalan) or myeloablative conditioning (MAC) (Busulfan and Fludarabine; or Cyclophosphamide and Total Body Irradiation) will be administered prior to allogeneic hematopoietic cell transplantation (HCT).
244725|NCT01410344|E1|Reported Event|Allogeneic Transplant|One regimen from either reduced-intensity conditioning (RIC) (Fludarabine and Busulfan; or Fludarabine and Melphalan) or myeloablative conditioning (MAC) (Busulfan and Fludarabine; or Cyclophosphamide and Total Body Irradiation) will be administered prior to allogeneic hematopoietic cell transplantation (HCT).
244726|NCT01410240|B4|Baseline|Total|Total of all reporting groups
244727|NCT01410240|B3|Baseline|FLOSEAL + Standard of Care (SoC) - Run-In|"Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.~FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~Standard of Care: Conventional hemostatic techniques, such as cautery and manual compression"
244728|NCT01410240|B2|Baseline|FLOSEAL + Standard of Care (SoC) - Non-Run-In|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~Standard of Care: Conventional hemostatic techniques, such as cautery and manual compression"
244729|NCT01410240|B1|Baseline|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244730|NCT01410240|P3|Participant Flow|FLOSEAL + Standard of Care (SoC) Run-In Participants|"This arm/group only includes the 12 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures and the use of FLOSEAL)~FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244731|NCT01410240|P2|Participant Flow|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244732|NCT01410240|P1|Participant Flow|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244733|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244734|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244735|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244736|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244744|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244745|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244746|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244747|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244748|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244749|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244750|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC) Including Run-In Participants|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression.~Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL."
244751|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244752|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC) Including Run-In Participants|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression.~Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL."
244753|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244754|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC) Including Run-In Participants|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression.~Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL."
244755|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244756|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244757|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244758|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244759|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244760|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244761|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244762|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244763|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244764|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244765|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244766|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244767|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244768|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244769|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244770|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244771|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244773|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244774|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244775|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244776|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244777|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244778|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244779|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244780|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244781|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244782|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244783|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244784|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244785|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244786|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244787|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244788|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244789|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244790|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244791|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244792|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244793|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244794|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244795|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244796|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244797|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244798|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244799|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244800|NCT01410240|E2|Reported Event|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
244801|NCT01410240|E1|Reported Event|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
244802|NCT01410227|B1|Baseline|All Subjects Treated With Study Product|All subjects treated with study product
244871|NCT01410227|O1|Outcome|Full Analysis Set|Comprised of participants treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) for whom at least one efficacy rating scale was available.
264007|NCT01348087|E5|Reported Event|AFQ056 100 mg Bid|AFQ056 100 mg bid
244803|NCT01410227|P4|Participant Flow|Arm 4: Treatment Only|In Part A, participants received on-demand treatment for bleeding episodes (BEs) with study product (recombinant von Willebrand Factor [rVWF] administered together with recombinant Factor VIII [rFVIII] (rVWF:rFVIII) or rVWF alone), where BEs were initially treated with rVWF:rFVIII and subsequently with rVWF with or without rFVIII, based on FVIII levels. If not available, the individual participant's PK data was used to determine rFVIII dose at discretion of investigator. Participants received on-demand treatment for 6 months after the first study product infusion. In part, B participants continued to receive on-demand treatment for BEs with study product [VWF:rFVIII or rVWF] for a further 6 months. No pharmacokinetic (PK) assessments were conducted in this arm.
244804|NCT01410227|P3|Participant Flow|Arm 3: PK80 + Treatment|In Part A, participants initially underwent a first PK assessment of an infusion of 80 IU/kg recombinant von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF]. After the first PK assessment participants received on demand treatment for bleeding episodes (BEs) with study product [VWF:rFVIII or rVWF], where BEs were initially treated with rVWF:rFVIII and subsequently with rWVF with or without rFVIII, based on FVIII levels. If FVIII levels not available, the individual participant's PK data was used to determine rFVIII dose at discretion of investigator. Participants received on-demand treatment for 6 months after the first study product infusion. After 6 months participants underwent a second PK assessment of an infusion of 80 IU/kg rVWF. In part B, participants continued to receive on-demand treatment for BEs with study product [VWF:rFVIII or rVWF] for a further 6 months.
244805|NCT01410227|P2|Participant Flow|Arm 2: PK50 Only|In Part A, (pharmacokinetic [PK] assessment followed by on-demand treatment for bleeding episodes [BEs] for 6 months) participants were initially infused either with 50 IU/kg recombinant von Willebrand Factor:von Willebrand Ristocetin cofactor (VWF:RCo rVWF) [rVWF] administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline. Participants then crossed over to the alternate infusion after washout (PK). For on-demand treatment, participants received study product [VWF:rFVIII or rVWF], where BEs were initially treated with rVWF:rFVIII and subsequently with rVWF with or without rFVIII, based on FVIII levels (dose based on previous FVIII levels or if not available from the individual participant's PK data at discretion of investigator). Participants then exited the study or could opt to sign informed consent to move to Arm 1 receive treatment for bleeding episodes with study product.
244806|NCT01410227|P1|Participant Flow|Arm 1: PK50 + Treatment|In Part A, (pharmacokinetic [PK] assessment followed by on-demand treatment for bleeding episodes [BEs] for 6 months) participants were initially infused either with 50 IU/kg recombinant von Willebrand Factor:von Willebrand Ristocetin cofactor (VWF:RCo rVWF) [rVWF] administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline. Participants then crossed over to the alternate infusion after washout (PK). For on-demand treatment, participants received study product [VWF:rFVIII or rVWF], where BEs were initially treated with rVWF:rFVIII and subsequently with rVWF with or without rFVIII, based on FVIII levels (dose based on previous FVIII levels or if not available from the individual participant's PK data at discretion of investigator). In part, B participants continued to receive on-demand treatment for BEs with study product [VWF:rFVIII or rVWF] for a further 6 months.
244807|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
244808|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
244809|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
244810|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
244811|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
244812|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
244813|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
244814|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
244815|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
244816|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
244872|NCT01410227|O1|Outcome|Full Analysis Set|Comprised of participants treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) for whom at least one efficacy rating scale was available.
244817|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
244818|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
244819|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
244820|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
244821|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
244822|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
244823|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
244824|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
244825|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
244826|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
244827|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
244828|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
244829|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
244830|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
244831|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244832|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244833|NCT01410227|O1|Outcome|Overall Study Arm|
244834|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244835|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244873|NCT01410227|O1|Outcome|Full Analysis Set|Comprises of participants treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) for whom at least one efficacy rating scale was available.
244836|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244837|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244838|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244839|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244840|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244841|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244842|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244843|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244844|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244845|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244846|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244847|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244848|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244849|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244925|NCT01409993|B3|Baseline|Total|Total of all reporting groups
244850|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244851|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244852|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244853|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244854|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244855|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244856|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244857|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244858|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total of participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
244859|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
244860|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
244861|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
244862|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
244863|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
244864|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
244865|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
244866|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
244867|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
244868|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
244869|NCT01410227|O1|Outcome|Full Analysis Set|Comprised of participants treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) for whom at least one efficacy rating scale was available.
244874|NCT01410227|E1|Reported Event|Safety Analysis Set|Comprises of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
244875|NCT01410110|B3|Baseline|Total|Total of all reporting groups
244876|NCT01410110|B2|Baseline|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
244877|NCT01410110|B1|Baseline|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
244878|NCT01410110|P2|Participant Flow|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
244879|NCT01410110|P1|Participant Flow|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
244880|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
244881|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
244882|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
244883|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
244884|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
244885|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
244886|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
244887|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
244888|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
244889|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
244890|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
244891|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
244892|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
244893|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
244894|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
244895|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
244896|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
244897|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
244898|NCT01410110|E2|Reported Event|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
244899|NCT01410110|E1|Reported Event|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
244900|NCT01410097|B3|Baseline|Total|Total of all reporting groups
244901|NCT01410097|B2|Baseline|Diabetes Support and Education (DSE)|Diabetes Support and Education offers an educational program to participants focusing on diet, physical activity, and social support (information on behavioral strategies are not presented).
244902|NCT01410097|B1|Baseline|Intensive Lifestyle Intervention (ILI)|Intensive Lifestyle Intervention that includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
244903|NCT01410097|P2|Participant Flow|Diabetes Support and Education (DSE)|"It offers an educational program to participants including developing support groups. Providing such benefits helps retain these participants in the trial.~Diabetes Support Education: It offers an educational program to participants including developing support groups. Providing such benefits helps retain these participants in the trial."
244904|NCT01410097|P1|Participant Flow|Lifestyle Intervention|"Intensive Lifestyle Intervention that includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.~Lifestyle intervention: Intensive Lifestyle Intervention that includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight."
244905|NCT01410097|O2|Outcome|Diabetes Support and Education (DSE)|Diabetes Support and Education offers an educational program to participants focusing on diet, physical activity, and social support (information on behavioral strategies are not presented).
244906|NCT01410097|O1|Outcome|Intensive Lifestyle Intervention (ILI)|Intensive Lifestyle Intervention includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
244907|NCT01410097|O2|Outcome|Diabetes Support and Education (DSE)|Diabetes Support and Education offers an educational program to participants focusing on diet, physical activity, and social support (information on behavioral strategies are not presented).
244908|NCT01410097|O1|Outcome|Intensive Lifestyle Intervention (ILI)|Intensive Lifestyle Intervention includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
244909|NCT01410097|O2|Outcome|Diabetes Support and Education (DSE)|Diabetes Support and Education offers an educational program to participants focusing on diet, physical activity, and social support (information on behavioral strategies are not presented).
244910|NCT01410097|O1|Outcome|Intensive Lifestyle Intervention (ILI)|Intensive Lifestyle Intervention includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
244911|NCT01410097|O2|Outcome|Diabetes Support and Education (DSE)|Diabetes Support and Education offers an educational program to participants focusing on diet, physical activity, and social support (information on behavioral strategies are not presented).
244912|NCT01410097|O1|Outcome|Intensive Lifestyle Intervention (ILI)|Intensive Lifestyle Intervention includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
244913|NCT01410097|O2|Outcome|Diabetes Support and Education (DSE)|Diabetes Support and Education offers an educational program to participants focusing on diet, physical activity, and social support (information on behavioral strategies are not presented).
244914|NCT01410097|O1|Outcome|Intensive Lifestyle Intervention (ILI)|Intensive Lifestyle Intervention includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
244915|NCT01410097|O2|Outcome|Diabetes Support and Education (DSE)|Diabetes Support and Education offers an educational program to participants focusing on diet, physical activity, and social support (information on behavioral strategies are not presented).
244916|NCT01410097|O1|Outcome|Intensive Lifestyle Intervention (ILI)|Intensive Lifestyle Intervention includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
244917|NCT01410097|O2|Outcome|Diabetes Support and Education (DSE)|Diabetes Support and Education offers an educational program to participants focusing on diet, physical activity, and social support (information on behavioral strategies are not presented).
244918|NCT01410097|O1|Outcome|Intensive Lifestyle Intervention (ILI)|Intensive Lifestyle Intervention includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
244919|NCT01410097|O2|Outcome|Diabetes Support and Education (DSE)|Diabetes Support and Education offers an educational program to participants focusing on diet, physical activity, and social support (information on behavioral strategies are not presented).
244920|NCT01410097|O1|Outcome|Intensive Lifestyle Intervention (ILI)|Intensive Lifestyle Intervention includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
244921|NCT01410097|O2|Outcome|Diabetes Support and Education (DSE)|Diabetes Support and Education offers an educational program to participants focusing on diet, physical activity, and social support (information on behavioral strategies are not presented).
244922|NCT01410097|O1|Outcome|Intensive Lifestyle Intervention (ILI)|Intensive Lifestyle Intervention includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
244923|NCT01410097|E2|Reported Event|Diabetes Support and Education (DSE)|"It offers an educational program to participants including developing support groups. Providing such benefits helps retain these participants in the trial.~Diabetes Support Education: It offers an educational program to participants including developing support groups. Providing such benefits helps retain these participants in the trial."
244924|NCT01410097|E1|Reported Event|Lifestyle Intervention|"Intensive Lifestyle Intervention that includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.~Lifestyle intervention: Intensive Lifestyle Intervention that includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight."
244926|NCT01409993|B2|Baseline|Placebo|"matching placebo p.o. tid~Administration of placebo: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) or a euglycemic (Aim 2) clamp and then receive sildenafil or placebo for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
244927|NCT01409993|B1|Baseline|Sildenafil|"sildenafil 25 mg p.o. tid~Administration of sildenafil: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) or a euglycemic (Aim 2) clamp and then receive sildenafil for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
244928|NCT01409993|P4|Participant Flow|Placebo Aim 2|Administration of Placebo: Subjects with prediabetes will have a baseline hyperinsulinemic euglycemic (Aim 2) and then receive placebo for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.
244929|NCT01409993|P3|Participant Flow|Sildenafil Aim 2|Administration of Sildenafil: Subjects with prediabetes will have a baseline hyperinsulinemic euglycemic (Aim 2) and then receive sildenafil for 3 months. Another euglycemic will be performed followed by another 3 months off drug and an oral glucose tolerance test.
244930|NCT01409993|P2|Participant Flow|Placebo Aim 1|"matching placebo p.o. tid~Administration of Placebo: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) and then receive placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
244931|NCT01409993|P1|Participant Flow|Sildenafil Aim 1|"sildenafil 25 mg p.o. tid~Administration of Sildenafil: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) and then receive sildenafil for 3 months. Another hyperglycemic will be performed followed by another 3 months off drug and an oral glucose tolerance test."
244932|NCT01409993|O4|Outcome|Placebo Aim 2|"matching placebo p.o. tid~Placebo: Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive placebo for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
244933|NCT01409993|O3|Outcome|Sildenafil Aim 2|"sildenafil 25 mg p.o. tid~Sildenafil: Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive sildenafil for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
244934|NCT01409993|O2|Outcome|Placebo Aim 1|"matching placebo p.o. tid~Placebo: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
244935|NCT01409993|O1|Outcome|Sildenafil Aim 1|"sildenafil 25 mg p.o. tid~Sildenafil: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive sildenafil for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
244936|NCT01409993|O4|Outcome|Placebo Aim 2|"matching placebo p.o. tid~Placebo: Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive placebo for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
244937|NCT01409993|O3|Outcome|Sildenafil Aim 2|"sildenafil 25 mg p.o. tid~Sildenafil: Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive sildenafil for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
244938|NCT01409993|O2|Outcome|Placebo Aim 1|"matching placebo p.o. tid~Administration of Placebo: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) and then receive sildenafil or placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
244939|NCT01409993|O1|Outcome|Sildenafil Aim 1|"sildenafil 25 mg p.o. tid~Administration of Sildenafil : Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) and then receive sildenafil for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
244940|NCT01409993|O2|Outcome|Placebo Aim 2|"matching placebo p.o. tid~Administration of Placebo: Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive placebo for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
244941|NCT01409993|O1|Outcome|Sildenafil Aim 2|"sildenafil 25 mg p.o. tid~Administration of Sildenafil : Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive sildenafil for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
244942|NCT01409993|O2|Outcome|Placebo Aim 1|"matching placebo p.o. tid~Administration of Placebo: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
244943|NCT01409993|O1|Outcome|Sildenafil Aim 1|"sildenafil 25 mg p.o. tid~Administration of Sildenafil: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive sildenafil for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
244944|NCT01409993|O2|Outcome|Placebo Aim 1|"matching placebo p.o. tid~Administration of Placebo: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
244945|NCT01409993|O1|Outcome|Sildenafil Aim 1|"sildenafil 25 mg p.o. tid~Administration of Sildenafil: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive sildenafil for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
244946|NCT01409993|E2|Reported Event|Placebo - Aims 1 and 2|"matching placebo p.o. tid~Administration of Placebo: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) or a euglycemic (Aim 2) and then receive placebo for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
244947|NCT01409993|E1|Reported Event|Sildenafil - Aims 1 and 2|"sildenafil 25 mg p.o. tid~Administration of Sildenafil: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) or a euglycemic (Aim 2) and then receive sildenafil for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
244952|NCT01409837|P1|Participant Flow|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril 2.5 mg taken once a day. Then crossed over to Sugar Pill taken also once a day. The Lisinopril and the Sugar Pill were made indistinguishable in appearance.
244953|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
244954|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
244955|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
244956|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
244957|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
244958|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
244959|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
244960|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
244961|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
244962|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
244963|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, then crossed over to Lisinopril
244964|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, then crossed over to Sugar Pill
244965|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, then crossed over to Lisinopril
244966|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, then crossed over to Sugar Pill
244967|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
244968|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
244969|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
244970|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
244971|NCT01409837|E2|Reported Event|Events Reported During Treatment With Placebo|All the events reported by patients in either group A or group B while receiving the Sugar Pill.
244972|NCT01409837|E1|Reported Event|Events Reported During Treatment With Lisinopril|All the events reported by patients in either group A or group B while receiving Lisinopril.
244973|NCT01409707|B4|Baseline|Total|Total of all reporting groups
244974|NCT01409707|B3|Baseline|Motivational Enhancement + Trauma-focused Exposure Therapy|A one session, 90 min. trauma-focused motivational enhancement therapy session was provided prior to starting the trauma-focused exposure therapy. EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
244975|NCT01409707|B2|Baseline|Trauma-focused Exposure Therapy|EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
244976|NCT01409707|B1|Baseline|Healthy Lifestyles Sessions|HLS is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided.
244977|NCT01409707|P3|Participant Flow|Motivational Enhancement + Trauma-focused Exposure Therapy|A one session, 90 min. trauma-focused motivational enhancement therapy session was provided prior to starting exposure therapy. Exposure therapy is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of posttraumatic stress disorder. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about posttraumatic stress disorder, a rationale for exposure therapy, and were taught breathing retraining as a method to manage arousal associated with posttraumatic stress disorder. Nine to 12 50-60 minutes sessions were provided.
244978|NCT01409707|P2|Participant Flow|Trauma-focused Exposure Therapy|Trauma-focused exposure therapy is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of posttraumatic stress disorder. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about posttraumatic stress disorder, a rationale for trauma-focused exposure therapy, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
244979|NCT01409707|P1|Participant Flow|Healthy Lifestyles Sessions|Healthy lifestyles sessions is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided.
244980|NCT01409707|O3|Outcome|Motivational Enhancement + Trauma-focused Exposure Therapy|One 90 min. motivational enhancement therapy session was provided prior to beginning trauma focused therapy. EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
244981|NCT01409707|O2|Outcome|Trauma-focused Exposure Therapy|EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
244982|NCT01409707|O1|Outcome|Healthy Lifestyles Sessions|HLS is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided.
244983|NCT01409707|O3|Outcome|Motivational Enhancement + Trauma-focused Exposure Therapy|One 90 min. motivational enhancement therapy session was provided prior to beginning trauma focused therapy. EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
244984|NCT01409707|O2|Outcome|Trauma-focused Exposure Therapy|EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
244985|NCT01409707|O1|Outcome|Healthy Lifestyles Sessions|HLS is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided.
244986|NCT01409707|E2|Reported Event|Trauma-focused Exposure Therapy|EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
244987|NCT01409707|E1|Reported Event|Healthy Lifestyles Sessions|HLS is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided.
244988|NCT01409564|B3|Baseline|Total|Total of all reporting groups
244989|NCT01409564|B2|Baseline|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
244990|NCT01409564|B1|Baseline|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
244991|NCT01409564|P2|Participant Flow|Placebo|Placebo group includes dementia patients receiving donepezil with placebo. All the patients were randomly assigned as placebo group and received 10 mg of Donepezil along with the same dose of sugar pill as normal cilostazol. All the clinical assessments and medications were doubly blinded. All the medications were orally administered.
244992|NCT01409564|P1|Participant Flow|Cilostazol|Cilostazol group includes dementia patients receiving donepezil with cilostazol augmentation. All the randomly assigned AD patients in cilostazol group received 10 mg of Donepezil along with 200 mg of cilostazol per a day, doubly blinded. All the medications were orally administered. For the initial two weeks, patients only received 100 mg of cilstazol per a day to minimize the instabilities. Afterwards, for 22 weeks, patients received 200 mg of cilostazol.
244993|NCT01409564|O2|Outcome|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
244994|NCT01409564|O1|Outcome|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
244995|NCT01409564|O2|Outcome|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
244996|NCT01409564|O1|Outcome|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
244997|NCT01409564|O2|Outcome|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
244998|NCT01409564|O1|Outcome|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
244999|NCT01409564|O2|Outcome|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
245000|NCT01409564|O1|Outcome|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
245001|NCT01409564|O2|Outcome|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
245002|NCT01409564|O1|Outcome|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
245003|NCT01409564|O4|Outcome|Placebo, 24-week|Placebo group means dementia patients group receiving donepezil with placebo after 24 weeks.
245004|NCT01409564|O3|Outcome|Placebo, Baseline|Placebo group means dementia patients group receiving donepezil with placebo at the baseline.
245005|NCT01409564|O2|Outcome|Cilostazol, 24-week|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation after 24 weeks.
245006|NCT01409564|O1|Outcome|Cilostazol, Baseline|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation at the baseline.
245007|NCT01409564|E2|Reported Event|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
245008|NCT01409564|E1|Reported Event|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
245009|NCT01409434|B1|Baseline|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
245010|NCT01409434|P1|Participant Flow|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
245011|NCT01409434|O1|Outcome|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
245012|NCT01409434|O1|Outcome|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
245013|NCT01409434|O1|Outcome|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
245014|NCT01409434|O1|Outcome|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
245015|NCT01409434|O1|Outcome|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
245016|NCT01409434|E1|Reported Event|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
245017|NCT01409382|B3|Baseline|Total|Total of all reporting groups
245018|NCT01409382|B2|Baseline|Standard Follow-up|Prenatal care will proceed according to the routine
245019|NCT01409382|B1|Baseline|Lifestyle Counseling|Daily brisk walking plus a carbohydrate-restricted diet
245020|NCT01409382|P2|Participant Flow|Standard Follow-up|Prenatal care will proceed according to the routine. Antidepressants will be not discontinued, but patients on paroxetine and sertraline will be switched to fluoxetine.
245021|NCT01409382|P1|Participant Flow|Lifestyle Counseling|Daily brisk walking plus a carbohydrate-restricted diet. Patients assigned to the intervention protocol will be instructed to walk briskly for at least 40 minutes seven days a week, to avoid high-carbohydrate meals (such as snacks, candies, fiber-free juices and sugar-sweetened beverages), and to eat at least two daily servings of meat, poultry, fish (e.g. 2 g/kg) or other protein-rich food, starting when they decided to get pregnant and continuing until delivery. Antidepressants will be not discontinued, but patients on paroxetine and sertraline will be switched to fluoxetine.
245022|NCT01409382|O2|Outcome|Standard Follow-up|Prenatal care will proceed according to the routine.
245023|NCT01409382|O1|Outcome|Lifestyle Counseling|Daily brisk walking plus a carbohydrate-restricted diet
245024|NCT01409382|O2|Outcome|Neonates Born to Controls|Neonates with hypoglycemia detected 1, 2 or 4 hours after birth
245025|NCT01409382|O1|Outcome|Neonates Born to Mothers Assigned to Protocol Walking+Diet|Neonates with hypoglycemia (blood glucose levels ≤ 40 mg/dL) at 1, 2 or 4 hours after birth
245026|NCT01409382|O2|Outcome|Standard Follow-up|Prenatal care will proceed according to the routine.
245027|NCT01409382|O1|Outcome|Lifestyle Counseling|Daily brisk walking plus a carbohydrate-restricted diet
245028|NCT01409382|E4|Reported Event|Lifestyle Counseling (Babies)|Exercise plus a carbohydrate-controlled diet.
245029|NCT01409382|E3|Reported Event|Standard Follow-up (Babies)|Prenatal care will proceed according to the routine.
245030|NCT01409382|E2|Reported Event|Lifestyle Counseling (Mothers)|Exercise plus a carbohydrate-controlled diet.
245031|NCT01409382|E1|Reported Event|Standard Follow-up (Mothers)|Prenatal care will proceed according to the routine.
245032|NCT01409291|B3|Baseline|Total|Total of all reporting groups
245033|NCT01409291|B2|Baseline|Children|Children between ages 3 and 18 years whose mothers were participating in the Financial Success Program.
245034|NCT01409291|B1|Baseline|Mothers|All participants of the Financial Success Program were approached for the study. This was a single arm descriptive study.
245035|NCT01409291|P2|Participant Flow|Children|Children between ages 3 and 18 years whose mothers were participating in the Financial Success Program.
245036|NCT01409291|P1|Participant Flow|Mothers|All participants of the Financial Success Program were approached for the study. This was a single arm descriptive study.
245037|NCT01409291|O2|Outcome|Children|Children between ages 3 and 18 years whose mothers were participating in the Financial Success Program.
245038|NCT01409291|O1|Outcome|Mothers|All participants of the Financial Success Program were approached for the study. This was a single arm descriptive study.
245039|NCT01409291|O2|Outcome|Children|Children between ages 3 and 18 years whose mothers were participating in the Financial Success Program.
245040|NCT01409291|O1|Outcome|Mothers|All participants of the Financial Success Program were approached for the study. This was a single arm descriptive study.
245041|NCT01409291|E2|Reported Event|Children|Children between ages 3 and 18 years whose mothers were participating in the Financial Success Program.
245042|NCT01409291|E1|Reported Event|Mothers|All participants of the Financial Success Program were approached for the study. This was a single arm descriptive study.
245043|NCT01409239|B3|Baseline|Total|Total of all reporting groups
245044|NCT01409239|B2|Baseline|Intravenous Insulin|IV insulin was started at 0500 hours the morning following consent. Patients continued to receive prandial and correction insulin until the IV insulin was started, after which only the prandial component was continued. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which was adapted from a published protocol and has a target glucose of 6.1-8.3 mmol/l. All floor nurses are trained in its use. Patients were transitioned from the infusion at 1700 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
245045|NCT01409239|B1|Baseline|Subcutaneous Insulin|Among patients receiving subcutaneous insulin, basal and prandial insulin were administered in approximately equal total daily doses with correction dosing. Daily adjustments were based upon 10-20% of the total daily dose.
245126|NCT01408888|E1|Reported Event|LY2189265|"LY2189265: a single, 1.5-milligram (mg) dose of LY2189265 administered subcutaneously on Day 1 of Treatment 1~Time frame: Treatment 1"
245746|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
245046|NCT01409239|P2|Participant Flow|Intravenous Insulin|IV insulin was started at 0500 hours the morning following consent. Patients continued to receive prandial and correction insulin until the IV insulin was started, after which only the prandial component was continued. All patients receiving IV insulin were managed using our hospital's universal nursing run guideline, which was adapted from a published protocol and has a target glucose of 6.1-8.3 mmol/l. All floor nurses are trained in its use. Patients were transitioned from the infusion at 1700 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
245047|NCT01409239|P1|Participant Flow|Subcutaneous Insulin|Among patients receiving subcutaneous insulin, basal and prandial insulin were administered in approximately equal total daily doses with correction dosing. Daily adjustments were based upon 10-20% of the total daily dose.
245048|NCT01409239|O2|Outcome|Intravenous Insulin|IV insulin was started at 0500 hours the morning following consent. Patients continued to receive prandial and correction insulin until the IV insulin was started, after which only the prandial component was continued. All patients receiving IV insulin were managed using our hospital's universal nursing run guideline, which was adapted from a published protocol and has a target glucose of 6.1-8.3 mmol/l. All floor nurses are trained in its use. Patients were transitioned from the infusion at 1700 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
245049|NCT01409239|O1|Outcome|Subcutaneous Insulin|Among patients receiving subcutaneous insulin, basal and prandial insulin were administered in approximately equal total daily doses with correction dosing. Daily adjustments were based upon 10-20% of the total daily dose.
245050|NCT01409239|E2|Reported Event|Intravenous Insulin|IV insulin was started at 0500 hours the morning following consent. Patients continued to receive prandial and correction insulin until the IV insulin was started, after which only the prandial component was continued. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which was adapted from a published protocol and has a target glucose of 6.1-8.3 mmol/l. All floor nurses are trained in its use. Patients were transitioned from the infusion at 1700 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
245051|NCT01409239|E1|Reported Event|Subcutaneous Insulin|Among patients receiving subcutaneous insulin, basal and prandial insulin were administered in approximately equal total daily doses with correction dosing. Daily adjustments were based upon 10-20% of the total daily dose.
245052|NCT01409213|B1|Baseline|All Enrolled Participants|Full analysis set (FAS) consisted of 1522 participants; one participant was excluded from the FAS due to missing data at baseline.
245053|NCT01409213|P1|Participant Flow|All Enrolled Participants|
245054|NCT01409213|O1|Outcome|All Enrolled Participants|All enrolled participants with available data.
245055|NCT01409213|O1|Outcome|All Enrolled Participants|All enrolled participants with available data.
245056|NCT01409213|E1|Reported Event|All Enrolled Participants|
245057|NCT01409096|B3|Baseline|Total|Total of all reporting groups
245058|NCT01409096|B2|Baseline|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.~Placebo: Inactive ingredient matching the active medication in appearance."
245059|NCT01409096|B1|Baseline|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.~Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
245060|NCT01409096|P2|Participant Flow|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.~Placebo: Inactive ingredient matching the active medication in appearance."
245061|NCT01409096|P1|Participant Flow|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.~Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
245062|NCT01409096|O2|Outcome|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.~Placebo: Inactive ingredient matching the active medication in appearance."
245063|NCT01409096|O1|Outcome|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.~Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
245064|NCT01409096|O2|Outcome|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.~Placebo: Inactive ingredient matching the active medication in appearance."
245065|NCT01409096|O1|Outcome|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.~Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
245066|NCT01409096|O2|Outcome|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.~Placebo: Inactive ingredient matching the active medication in appearance."
245067|NCT01409096|O1|Outcome|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.~Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
245068|NCT01409096|O2|Outcome|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.~Placebo: Inactive ingredient matching the active medication in appearance."
245069|NCT01409096|O1|Outcome|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.~Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
245070|NCT01409096|E2|Reported Event|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.~Placebo: Inactive ingredient matching the active medication in appearance."
245747|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
245071|NCT01409096|E1|Reported Event|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.~Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
245072|NCT01408992|B1|Baseline|Community People|The Phu Wieng district in Khon Kaen Province was chosen as a representative rural community in Thailand. A total of 551 subjects were required to obtain an 80% sensitivity rate for the original test, at a 95% confidence level, with 80% power, and a 7% margin of error. Considering 22.7% as the estimated prevalence of hearing loss [Prasansuk, 2000] and a 10% drop out rate, the total number of subjects needed was 606. The subjects were recruited from different target villages. The villages had been divided according to their municipality. The target villages were simply randomly selected from a list of villages that have more than 300 adults in their populations. One village was from a municipal area and the other village was from a non-municipal area. All of the people in the target villages, who were older
245073|NCT01408992|P1|Participant Flow|Community People|The Phu Wieng district in Khon Kaen Province was chosen as a representative rural community in Thailand. This district comprises 114 villages and has a population of 24,201 inhabitants. Of these, 13,001 inhabitants lived in municipal areas, whereas the rest lived in non-municipal areas. The subjects were recruited from different target villages. The villages had been divided according to their municipality. The target villages were simply randomly selected from a list of villages that have more than 300 adults in their populations. One village was from a municipal area and the other village was from a non-municipal area. All of the people in the target villages, who were older than 18 years, could read or understand the Thai language, and wanted to participate, were recruited. Those who had aphasia, severe mental disability, or other conditions that precluded audiometry were excluded.
245074|NCT01408992|O1|Outcome|Hearing Loss|The severity of hearing loss was defined by the pure tone average air-conduction threshold at the speech frequencies of the better hearing ears, according to the ASHA criteria. Normal hearing means PTA of less than or equal 25 dB. Mild hearing loss means PTA of 26-40 dB. Moderate hearing loss means PTA of 41-55 dB. Moderately severe hearing loss means PTA of 56-74 dB. Severe hearing loss means PTA of 75-90 dB. Profound hearing loss means PTA > 90 dB.
245075|NCT01408992|O1|Outcome|FMHT|"FMHT Score is the sum of value of the answers for each question. If the subject answers never, it will be scored as 0, occasionally will be 1, half the time will be 2, and almost always will be 3."
245076|NCT01408992|O7|Outcome|Mixed Hearing Loss|Air and bone conduction threshold are more than 25 dB with air-bone gap
245077|NCT01408992|O6|Outcome|Sensorineural Hearing Loss|Air and bone conduction thresholds are more than 25 dB
245078|NCT01408992|O5|Outcome|Conductive Hearing Loss|Air-bone gap and bone conduction thresholds are lower than 25 dB
245079|NCT01408992|O4|Outcome|Chronic Otitis Media|Tympanic membrane perforation with or without ear discharge
245080|NCT01408992|O3|Outcome|Otitis Media With Effusion|Fluid in middle ear, whether serous, mucoid, mucous, or pus
245081|NCT01408992|O2|Outcome|Ear Wax|Impacted cerumen
245082|NCT01408992|O1|Outcome|Normal Ears and Hearing|Normal ear examination and normal hearing
245083|NCT01408992|E1|Reported Event|Community People|All people who live in the Phu Wieng district in Khon Kaen Province was chosen as a representative of community people in Thailand.
245084|NCT01408914|B4|Baseline|Total|Total of all reporting groups
245085|NCT01408914|B3|Baseline|20 mg/kg|20 mg/kg RIF
245086|NCT01408914|B2|Baseline|15 mg/kg|15 mg/kg RIF
245087|NCT01408914|B1|Baseline|10 mg/kg|10 mg/kg RIF
245088|NCT01408914|P3|Participant Flow|20 mg/kg|20 mg/kg RIF
245089|NCT01408914|P2|Participant Flow|15 mg/kg|15 mg/kg RIF
245090|NCT01408914|P1|Participant Flow|10 mg/kg|10 mg/kg RIF
245091|NCT01408914|O3|Outcome|20 mg/kg|20 mg/kg RIF
245092|NCT01408914|O2|Outcome|15 mg/kg|15 mg/kg RIF
245093|NCT01408914|O1|Outcome|10 mg/kg|10 mg/kg RIF
245094|NCT01408914|O3|Outcome|20 mg/kg|20 mg/kg RIF
245095|NCT01408914|O2|Outcome|15 mg/kg|15 mg/kg RIF
245096|NCT01408914|O1|Outcome|10 mg/kg|10 mg/kg RIF
245097|NCT01408914|O3|Outcome|20 mg/kg|20 mg/kg RIF
245098|NCT01408914|O2|Outcome|15 mg/kg|15 mg/kg RIF
245099|NCT01408914|O1|Outcome|10 mg/kg|10 mg/kg RIF
245100|NCT01408914|E3|Reported Event|20 mg/kg|20 mg/kg RIF
245101|NCT01408914|E2|Reported Event|15 mg/kg|15 mg/kg RIF
245102|NCT01408914|E1|Reported Event|10 mg/kg|10 mg/kg RIF
245103|NCT01408888|B1|Baseline|Entire Study Population|Participants who received at least one dose of study drug (LY2189265 or Sitagliptin).
245104|NCT01408888|P2|Participant Flow|Sitagliptin + LY2189265, LY2189265|"First Intervention Period: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2).~Second Intervention Period: A single 1.5-mg SC injection of LY2189265 on Day 1 (Treatment 1).~There was a washout of at least 21 days between treatments."
245105|NCT01408888|P1|Participant Flow|LY2189265, Sitagliptin + LY2189265|"First Intervention Period: A single 1.5-milligram (mg) subcutaneous (SC) injection of LY2189265 on Day 1 (Treatment 1).~Second Intervention Period: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2).~There was a washout of at least 21 days between treatments."
245106|NCT01408888|O3|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 12)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 12 of Treatment 2.
245124|NCT01408888|E3|Reported Event|Sitagliptin + LY2189265|"Sitagliptin + LY2189265: 100-mg dose of sitagliptin administered orally, once daily from Day 5 to Day 18 of Treatment 2 in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 of Treatment 2.~Time Frame: Day 5 to end of Treatment 2"
245748|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
245107|NCT01408888|O2|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 5)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 5 of Treatment 2.
245108|NCT01408888|O1|Outcome|1.5 mg LY2189265 (Day 1)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 1 of Treatment 1.
245109|NCT01408888|O3|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 12)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5 mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 12 of Treatment 2.
245110|NCT01408888|O2|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 5)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5 mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 5 of Treatment 2.
245111|NCT01408888|O1|Outcome|1.5 mg LY2189265 (Day 1)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5 mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 1 of Treatment 1.
245112|NCT01408888|O3|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 12)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 12 of Treatment 2.
245113|NCT01408888|O2|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 5)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 5 of Treatment 2.
245114|NCT01408888|O1|Outcome|1.5 mg LY2189265 (Day 1)|Sitagliptin + LY2189265: A single, 1.5-milligram (mg) dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 1 of Treatment 1.
245115|NCT01408888|O3|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 13)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 13.
245116|NCT01408888|O2|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 6)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 6.
245117|NCT01408888|O1|Outcome|100 mg Sitagliptin (Day 4)|Sitagliptin + LY2189265: 100 milligrams (mg) of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single subcutaneous (SC) injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 4.
245118|NCT01408888|O3|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 13)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 13.
245119|NCT01408888|O2|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 6)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg of LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 6.
245120|NCT01408888|O1|Outcome|100 mg Sitagliptin (Day 4)|Sitagliptin + LY2189265: 100 milligrams (mg) of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single subcutaneous (SC) injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 4.
245121|NCT01408888|O3|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 13)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 13.
245122|NCT01408888|O2|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 6)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 6.
245123|NCT01408888|O1|Outcome|100 mg Sitagliptin (Day 4)|Sitagliptin + LY2189265: 100 milligrams (mg) of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single subcutaneous (SC) injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 4.
245125|NCT01408888|E2|Reported Event|Sitagliptin|"Sitagliptin: 100-mg dose of sitagliptin, administered orally, once daily before the LY2189265 dose on Day 1 to Day 5 of Treatment 2.~Time Frame: Day 1 to Day 5 of Treatment 2"
245749|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
245127|NCT01408862|B1|Baseline|Controls|Platelets from healthy human subjects who were not taken any medication in the previous 10 days were studied. Blood samples (30 ml) were drawn with i) ACD-C (9:1, v/v) (7 mmol/L citric acid, 93 mmol/L citrate, 139 mmol/L dextrose, pH 6.4) for gene expression and western blot studies; ii) with 1% EDTA for flow cytometry and iii) with 3.8% sodium citrate for functional studies. Blood samples were centrifuged at 150 g for 10 min to obtain platelet-rich plasma (PRP).
245128|NCT01408862|P1|Participant Flow|Controls|"20 healthy volunteers were asked to donor a 10-80 ml blood through a venous puncture~venous puncture: Blood for in vitro studies were drawn"
245129|NCT01408862|O1|Outcome|Controls|"Healthy volunteers were asked to donor a 10-80 ml blood through a venous puncture~venous puncture: Blood for in vitro studies were drawn"
245130|NCT01408862|O1|Outcome|Controls|Flow cytometry studies In order to test the presence of GLP1 and GIP receptors on normal platelet membrane, indirect immunodetection was carried out in platelet samples from 20 normal donors.
245131|NCT01408862|E1|Reported Event|Controls|"Healthy volunteers were asked to donor a 10-80 ml blood through a venous puncture~venous puncture: Blood for in vitro studies were drawn"
245132|NCT01408732|B1|Baseline|Entire Study Population|
245133|NCT01408732|P2|Participant Flow|Standard Treatment Then Sclerotherapy|"The standard treatment group will continue their pre-study standard treatment methods to treat epistaxis on the first 6 weeks of the study, followed by intervention with sclerotherapy on the second 6 weeks of the study, plus any additionally needed standard treatments for breakthrough epistaxis. Wash out period 2 weeks"
245134|NCT01408732|P1|Participant Flow|Sclerotherapy Intervention Then Standard Treatment|This group will receive, on the first period of the study, sclerotherapy with STS to any visible lesions in the nose at the outset, followed by any needed standard treatments for breakthrough epistaxis. Washout period of 2 weeks
245135|NCT01408732|O2|Outcome|Standard Treatment|"The standard treatment group will continue their pre-study standard treatment methods to treat epistaxis on the first period of the study, followed by intervention with sclerotherapy on the second period of the study, plus any additionally needed standard treatments for breakthrough epistaxis. Standard treatment may include nasal packing, cauterization, laser treatments, microdebrider, septodermoplasty, and any other treatments that the patient reports using that are accepted as standard of care.~Sodium tetradecyl sulfate (STS) is injected into the nasal lesions as a solution prepared by foaming STS with air at a 4:1 ratio. Individual injection amounts vary between lesions, patients and treatment sessions. No more than a total of 3 ml of solution is used in each session. Multiple lesions can be treated bilaterally, each with a separate injection.~Standard Treatment"
245136|NCT01408732|O1|Outcome|Sclerotherapy Intervention|"This group will receive, on the first period of the study, sclerotherapy with STS to any visible lesions in the nose at the outset, followed by any needed standard treatments for breakthrough epistaxis. On the second period of the study this group will continue with standard treatments that they had been receiving for epistaxis prior to the study. Standard treatment may include nasal packing, cauterization, laser treatments, microdebrider, and septodermoplasty.~Sodium tetradecyl sulfate (sotradecol): 3% Sodium tetradecyl sulfate (STS) is mixed with air at a ratio of 4 parts air to 1 part STS for injection into the affected vessels in the nose. Topical anesthetic is applied to the nasal mucosa prior to injections. Once the mixture is ready for injection, the needle is placed into the vessel, in a submucosal fashion, penetrating 1-2 mm, and very small quantities of foam are injected"
245137|NCT01408732|E2|Reported Event|Standard Treatment|"The standard treatment group will continue their pre-study standard treatment methods to treat epistaxis on the first period of the study, followed by intervention with sclerotherapy on the second period of the study, plus any additionally needed standard treatments for breakthrough epistaxis. Standard treatment may include nasal packing, cauterization, laser treatments, microdebrider, septodermoplasty, and any other treatments that the patient reports using that are accepted as standard of care.~Sodium tetradecyl sulfate (STS) is injected into the nasal lesions as a solution prepared by foaming STS with air at a 4:1 ratio. Individual injection amounts vary between lesions, patients and treatment sessions. No more than a total of 3 ml of solution is used in each session. Multiple lesions can be treated bilaterally, each with a separate injection.~Standard Treatment"
245138|NCT01408732|E1|Reported Event|Sclerotherapy Intervention|"This group will receive, on the first period of the study, sclerotherapy with STS to any visible lesions in the nose at the outset, followed by any needed standard treatments for breakthrough epistaxis. On the second period of the study this group will continue with standard treatments that they had been receiving for epistaxis prior to the study. Standard treatment may include nasal packing, cauterization, laser treatments, microdebrider, and septodermoplasty.~Individual injection amounts vary between lesions, patients and treatment sessions. No more than 3 ml of solution is used in each session."
245139|NCT01408719|B21|Baseline|Total|Total of all reporting groups
245140|NCT01408719|B20|Baseline|Sequence 20|3g HMW, followed by 5g LMW, followed by control, followed by 3g LMW
245141|NCT01408719|B19|Baseline|Sequence 19|Control, followed by 3g HMW, followed by 3g LMW, followed by 5g LMW
245142|NCT01408719|B18|Baseline|Sequence 18|5g LMW, followed by 3g HMW, followed by control, followed by 3g LMW
245143|NCT01408719|B17|Baseline|Sequence 17|3g HMW, followed by 3g LMW, followed 5g LMW, followed by control
245144|NCT01408719|B16|Baseline|Sequence 16|3g HMW, followed by 5g LMW, followed 3g LMW, followed by control
245145|NCT01408719|B15|Baseline|Sequence 15|3g LMW, followed by 5g LMW, followed by control, followed by 3g HMW
245146|NCT01408719|B14|Baseline|Sequence 14|3g LMW, followed by 5g LMW, followed by 3g HMW, followed by control
245147|NCT01408719|B13|Baseline|Sequence 13|3g HMW, followed by control, followed by 3g LMW, followed by 5g LMW
245148|NCT01408719|B12|Baseline|Sequence 12|5g LMW, followed by control, followed by 3g LMW, followed by 3g HMW
245149|NCT01408719|B11|Baseline|Sequence 11|3g HMW, followed by control, followed by 5g LMW, followed by 3g LMW
245150|NCT01408719|B10|Baseline|Sequence 10|Control, followed by 3g LMW, followed by 5g LMW, followed by 3g HMW
245151|NCT01408719|B9|Baseline|Sequence 9|Control, followed by 5g HMW, followed by 3g LMW, followed by 3g HMW
245152|NCT01408719|B8|Baseline|Sequence 8|3g LMW, followed by 3g HMW, followed by control, followed by 5g HMW
245153|NCT01408719|B7|Baseline|Sequence 7|5g LMW, followed by 3g LMW, followed control, followed by 3g HMW
245154|NCT01408719|B6|Baseline|Sequence 6|control, followed by 5g LMW, followed by 3g HMW, followed by 3g LMW
245156|NCT01408719|B4|Baseline|Sequence 4|5g LMW, followed by 3g LMW, followed by 3g HMW, followed by control
245157|NCT01408719|B3|Baseline|Sequence 3|3g LMW, followed by 3g HMW, followed by 5g LMW, followed by control
245158|NCT01408719|B2|Baseline|Sequence 2|Control, followed by 3g HMW, followed by 5g LMW, followed by 3g LMW
245159|NCT01408719|B1|Baseline|Sequence 1|3g LMW followed by control, followed by 3g HMW, followed by 5g LMW
245160|NCT01408719|P20|Participant Flow|Sequence 20|3g HMW, followed by 5g LMW, followed by control, followed by 3g LMW
245161|NCT01408719|P19|Participant Flow|Sequence 19|Control, followed by 3g HMW, followed by 3g LMW, followed by 5g LMW
245162|NCT01408719|P18|Participant Flow|Sequence 18|5g LMW, followed by 3g HMW, followed by control, followed by 3g LMW
245163|NCT01408719|P17|Participant Flow|Sequence 17|3g HMW, followed by 3g LMW, followed 5g LMW, followed by control
245164|NCT01408719|P16|Participant Flow|Sequence 16|3g HMW, followed by 5g LMW, followed 3g LMW, followed by control
245165|NCT01408719|P15|Participant Flow|Sequence 15|3g LMW, followed by 5g LMW, followed by control, followed by 3g HMW
245166|NCT01408719|P14|Participant Flow|Sequence 14|3g LMW, followed by 5g LMW, followed by 3g HMW, followed by control
245167|NCT01408719|P13|Participant Flow|Sequence 13|3g HMW, followed by control, followed by 3g LMW, followed by 5g LMW
245168|NCT01408719|P12|Participant Flow|Sequence 12|5g LMW, followed by control, followed by 3g LMW, followed by 3g HMW
245169|NCT01408719|P11|Participant Flow|Sequence 11|3g HMW, followed by control, followed by 5g LMW, followed by 3g LMW
245170|NCT01408719|P10|Participant Flow|Sequence 10|Control, followed by 3g LMW, followed by 5g LMW, followed by 3g HMW
245171|NCT01408719|P9|Participant Flow|Sequence 9|Control, followed by 5g HMW, followed by 3g LMW, followed by 3g HMW
245172|NCT01408719|P8|Participant Flow|Sequence 8|3g LMW, followed by 3g HMW, followed by control, followed by 5g HMW
245173|NCT01408719|P7|Participant Flow|Sequence 7|5g LMW, followed by 3g LMW, followed control, followed by 3g HMW
245174|NCT01408719|P6|Participant Flow|Sequence 6|control, followed by 5g LMW, followed by 3g HMW, followed by 3g LMW
245175|NCT01408719|P5|Participant Flow|Sequence 5|3g HMW, followed by 3g LMW, followed by control, followed by 5g LMW
245176|NCT01408719|P4|Participant Flow|Sequence 4|5g LMW, followed by 3g LMW, followed by 3g HMW, followed by control
245177|NCT01408719|P3|Participant Flow|Sequence 3|3g LMW, followed by 3g HMW, followed by 5g LMW, followed by control
245178|NCT01408719|P2|Participant Flow|Sequence 2|Control, followed by 3g HMW, followed by 5g LMW, followed by 3g LMW
245179|NCT01408719|P1|Participant Flow|Sequence 1|3g LMW followed by control, followed by 3g HMW, followed by 5g LMW
245180|NCT01408719|O4|Outcome|Control|"control diet containing negligible amount of beta glucan~3g HMW beta-glucan: 3 grams of high molecular weight beta-glucan"
245181|NCT01408719|O3|Outcome|3g LMW Beta Glucan|"3 grams of low molecular weight beta-glucan diet for 35 days~5g LMW beta-glucan: 5 grams beta-glucan"
245182|NCT01408719|O2|Outcome|3g HMW Beta Glucan|"3 gram high molecular weight barley beta-glucan diet for 35 days~3g LMW beta-glucan: 3grams beta-glucan"
245183|NCT01408719|O1|Outcome|5g LMW Beta Glucan|"5 gram low molecular weight barley beta-glucan diet for 35 days~Control: Minimal beta-glucan"
245184|NCT01408719|E4|Reported Event|5g LMW Beta-glucan|5 grams low molecular weight barley beta-glucan
245185|NCT01408719|E3|Reported Event|3g LMW Beta-glucan|3 grams low molecular weight barley beta-glucan
245186|NCT01408719|E2|Reported Event|3g HMW Beta-glucan|3 grams high molecular weight barley beta-glucan
245187|NCT01408719|E1|Reported Event|Control|Minimal barley and minimal beta-glucan
245188|NCT01408706|B3|Baseline|Total|Total of all reporting groups
245189|NCT01408706|B2|Baseline|Radiadyne Immobilizer Treatment Device|"Use of Radiadyne Immobilizer Treatment Device to fix prostate location and displace rectal tissue during radiation therapy~Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
245190|NCT01408706|B1|Baseline|Miller Enema Air Tip|"Use of Miller enema air tip to fix prostate location and displace rectal tissue during radiation therapy.~Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
245191|NCT01408706|P2|Participant Flow|Radiadyne Immobilizer Treatment Device|"Use of Radiadyne Immobilizer Treatment Device to fix prostate location and displace rectal tissue during radiation therapy~Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
245192|NCT01408706|P1|Participant Flow|Miller Enema Air Tip|"Use of Miller enema air tip to fix prostate location and displace rectal tissue during radiation therapy.~Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
245193|NCT01408706|O2|Outcome|Radiadyne Immobilizer Treatment Device|The Radiadyne Immobilizer Treatment Device is inserted into the rectum prior to radiation simulation and also prior to each radiation treatment to immobilize prostate gland and displace rectal tissue during radiation therapy
245194|NCT01408706|O1|Outcome|Miller Enema Air Tip|The Miller enema air tip rectal balloon is inserted into the rectum prior to radiation simulation and also prior to each radiation treatment to immobilize prostate gland and displace rectal tissue during radiation therapy.
245195|NCT01408706|O2|Outcome|Radiadyne Immobilizer Treatment Device|"Use of Radiadyne Immobilizer Treatment Device to fix prostate location and displace rectal tissue during radiation therapy~Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
245219|NCT01408537|P1|Participant Flow|JEVAC|JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
245196|NCT01408706|O1|Outcome|Miller Enema Air Tip|"Use of Miller enema air tip to fix prostate location and displace rectal tissue during radiation therapy.~Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
245197|NCT01408706|O2|Outcome|Radiadyne Immobilizer Treatment Device|"Use of Radiadyne Immobilizer Treatment Device to fix prostate location and displace rectal tissue during radiation therapy~Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
245198|NCT01408706|O1|Outcome|Miller Enema Air Tip|"Use of Miller enema air tip to fix prostate location and displace rectal tissue during radiation therapy.~Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
245199|NCT01408706|E2|Reported Event|Radiadyne Immobilizer Treatment Device|"Use of Radiadyne Immobilizer Treatment Device to fix prostate location and displace rectal tissue during radiation therapy~Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
245200|NCT01408706|E1|Reported Event|Miller Enema Air Tip|"Use of Miller enema air tip to fix prostate location and displace rectal tissue during radiation therapy.~Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
245201|NCT01408641|B3|Baseline|Total|Total of all reporting groups
245202|NCT01408641|B2|Baseline|Placebo (Sugar Pill)|"Placebo arm will receive matching capsules without topiramate.~Placebo: Placebo capsules without topiramate"
245203|NCT01408641|B1|Baseline|Topiramate|"Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose.~Topiramate: Topiramate titrated over 6 weeks to 400mg or highest tolerated dose."
245204|NCT01408641|P2|Participant Flow|Placebo (Sugar Pill)|"Placebo arm will receive matching capsules without topiramate.~Placebo: Placebo capsules without topiramate"
245205|NCT01408641|P1|Participant Flow|Topiramate|"Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose.~Topiramate: Topiramate titrated over 6 weeks to 400mg or highest tolerated dose."
245206|NCT01408641|O2|Outcome|Placebo (Sugar Pill)|"Placebo arm will receive matching capsules without topiramate.~Placebo: Placebo capsules without topiramate"
245207|NCT01408641|O1|Outcome|Topiramate|"Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose.~Topiramate: Topiramate titrated over 6 weeks to 400mg or highest tolerated dose."
245208|NCT01408641|O2|Outcome|Placebo (Sugar Pill)|"Placebo arm will receive matching capsules without topiramate.~Placebo: Placebo capsules without topiramate"
245209|NCT01408641|O1|Outcome|Topiramate|"Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose.~Topiramate: Topiramate titrated over 6 weeks to 400mg or highest tolerated dose."
245210|NCT01408641|E2|Reported Event|Placebo (Sugar Pill)|"Placebo arm will receive matching capsules without topiramate.~Placebo: Placebo capsules without topiramate"
245211|NCT01408641|E1|Reported Event|Topiramate|"Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose.~Topiramate: Topiramate titrated over 6 weeks to 400mg or highest tolerated dose."
245212|NCT01408628|B1|Baseline|Internet Insulin Education|Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (“live”) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of < 7.0% using an established treat-to-target algorithm.
245213|NCT01408628|P1|Participant Flow|Internet Insulin Education|Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (“live”) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of < 7.0% using an established treat-to-target algorithm.
245214|NCT01408628|O1|Outcome|Internet Insulin Education|Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (“live”) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of < 7.0% using an established treat-to-target algorithm.
245215|NCT01408628|O1|Outcome|Internet Insulin Education|Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (“live”) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of < 7.0% using an established treat-to-target algorithm.
245216|NCT01408628|O1|Outcome|Internet Insulin Education|Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (“live”) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of ≤ 7.0% using an established treat-to-target algorithm.
245217|NCT01408628|E1|Reported Event|Internet Insulin Education|Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (“live”) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of < 7.0% using an established treat-to-target algorithm.
245218|NCT01408537|B1|Baseline|JEVAC|JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
264008|NCT01348087|E4|Reported Event|AFQ056 75 mg Bid|AFQ056 75 mg bid
245220|NCT01408537|O1|Outcome|JEVAC|JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
245221|NCT01408537|O8|Outcome|SAEs Entire the Study|SAEs which occured entire the study period were recorded.
245222|NCT01408537|O7|Outcome|Unsolicited AEs After Each Vaccination|unsolicited AEs after each vaccinations (3 doses). Episode of unsolicited AEs (excluded SAEs) were collected up to 28 days after each vaccination
245223|NCT01408537|O6|Outcome|Urticaria After Vaccination|Urticaria after each vaccinations (3 doses). Episode of Urticaria was collected up to 28 days after each vaccination.
245224|NCT01408537|O5|Outcome|Vomiting After Vaccination|Vomiting after each vaccinations (3 doses). Episode of vomiting was collected up to 28 days after each vaccination.
245225|NCT01408537|O4|Outcome|Poor Appetite After Vaccination|Poor appetite after each vaccinations (3 doses). Episode of poor appetite was collected up to 28 days after each vaccination.
245226|NCT01408537|O3|Outcome|Chills After Vaccination|Chills after each vaccinations (3 doses). Episode of chills was collected up to 28 days after each vaccination.
245227|NCT01408537|O2|Outcome|Local AE JEVAC After Vaccination|"Local Adverse event (tenderness, redness, ecchymosis, hematoma and swelling) after each vaccinations the first vaccination was on day of enrollment, the second dose was Day7 (+21day))~, Booster vaccine was on 1 year(+30days). Local AEs were collected up to 28 days after each vaccination."
245228|NCT01408537|O1|Outcome|Fever After Vaccination|Fever (Temp > =37.5 Axillary )after each vaccinations (3 doses). Episode of fever was collected up to 28 days after each vaccination.
245229|NCT01408537|O3|Outcome|GMT of NT Titer After Booster Vaccine|GMT of NT of subject at 28 days after booster vaccination. Exclude NT titer >=10 before first vaccination and subjects received JE vaccine outside the study.
245230|NCT01408537|O2|Outcome|GMT of NT Before Booster Vaccine|GMT of NT of subject at 1 year before booster vaccination. Exclude NT titer >=10 before first vaccination and subjects received JE vaccine outside the study.
245231|NCT01408537|O1|Outcome|GMT of NT on 28days After Vaccination|GMT of NT titer of subjects on 28 days after vaccination (excluded the subject who had NT titer > =10 before first vaccination).
245232|NCT01408537|O1|Outcome|JEVAC|JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
245233|NCT01408537|E1|Reported Event|JEVAC|JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
245234|NCT01408485|B1|Baseline|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:~Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter~IBI 1500T9 V1.43 RF Generator"
245235|NCT01408485|P1|Participant Flow|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:~Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter~IBI 1500T9 V1.43 RF Generator"
245236|NCT01408485|O1|Outcome|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:~Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter~IBI 1500T9 V1.43 RF Generator"
245237|NCT01408485|O1|Outcome|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:~Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter~IBI 1500T9 V1.43 RF Generator"
245238|NCT01408485|O1|Outcome|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:~Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter~IBI 1500T9 V1.43 RF Generator"
245239|NCT01408485|E1|Reported Event|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:~Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter~IBI 1500T9 V1.43 RF Generator"
245240|NCT01408329|B3|Baseline|Total|Total of all reporting groups
245241|NCT01408329|B2|Baseline|Cyclic Hypoxic Group|Rapidly fluctuating pressures simulating altitude up to 6096 meters
245242|NCT01408329|B1|Baseline|Sham Group|Slowly fluctuating pressures simulating altitude up to 607 meters
245243|NCT01408329|P2|Participant Flow|Cyclic Hypoxic Group|Rapidly fluctuating pressures simulating altitude up to 6096 meters
245244|NCT01408329|P1|Participant Flow|Sham Group|Slowly fluctuating pressures simulating altitude up to 607 meters
245245|NCT01408329|O2|Outcome|Cyclic Hypoxic Group|Rapidly fluctuating pressures simulating altitude up to 6097m
245246|NCT01408329|O1|Outcome|Sham Group|Slowly fluctuating pressures simulating altitude up to 607 meters
245247|NCT01408329|E2|Reported Event|Cyclic Hypoxic Group|Rapidly fluctuating simulated altitude up to 6097 meters
245248|NCT01408329|E1|Reported Event|Sham Group|Slowly fluctuating simulated altitude up to 607 meters.
245249|NCT01408303|B4|Baseline|Total|Total of all reporting groups
245250|NCT01408303|B3|Baseline|Placebo|"placebo, 1 g capsule~placebo : 4 x 1 g capsule daily for 6 weeks"
245251|NCT01408303|B2|Baseline|Epanova, 4 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids: omega-3-carboxylic acids 4 x 1 g capsule daily for 6 weeks
245252|NCT01408303|B1|Baseline|Epanova, 2 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids + placebo : omega-3-carboxylic acids 2 x 1 g capsule + placebo 2 x 1 g capsule daily for 6 weeks
245253|NCT01408303|P3|Participant Flow|Olive Oil + Statin|"olive oil, 1 g capsule~olive oil: 4 x 1 g capsule daily for 6 weeks~prescribed statin"
245254|NCT01408303|P2|Participant Flow|Epanova, 4 g + Statin|"omega-3 carboxylic acids, 1 g capsule~omega-3 carboxylic acids: omega-3 carboxylic acids 4 x 1 g capsule daily for 6 weeks~prescribed statin"
245255|NCT01408303|P1|Participant Flow|Epanova, 2 g + Statin|"omega-3 carboxylic acids, 1 g capsule~omega-3 carboxylic acids + olive oil: omega-3 carboxylic acids 2 x 1 g capsule + olive oil 2 x 1 g capsule daily for 6 weeks~prescribe statin"
245256|NCT01408303|O3|Outcome|Placebo|"placebo, 1 g capsule~placebo : 4 x 1 g capsule daily for 6 weeks"
264009|NCT01348087|E3|Reported Event|AFQ056 50 mg Bid|AFQ056 50 mg bid
245257|NCT01408303|O2|Outcome|Epanova 4 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids: omega-3-carboxylic acids 4 x 1 g capsule daily for 6 weeks
245258|NCT01408303|O1|Outcome|Epanova 2 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids + placebo: omega-3-carboxylic acids 2 x 1 g capsule + placebo 2 x 1 g capsule daily for 6 weeks
245259|NCT01408303|E3|Reported Event|Placebo|"placebo, 1 g capsule~placebo : 4 x 1 g capsule daily for 6 weeks"
245260|NCT01408303|E2|Reported Event|Epanova, 4 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids: omega-3-carboxylic acids 4 x 1 g capsule daily for 6 weeks
245261|NCT01408303|E1|Reported Event|Epanova, 2 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids + placebo : omega-3-carboxylic acids 2 x 1 g capsule + placebo 2 x 1 g capsule daily for 6 weeks
245262|NCT01408277|B3|Baseline|Total|Total of all reporting groups
245263|NCT01408277|B2|Baseline|Control|Standard Care
245264|NCT01408277|B1|Baseline|Santyl|Collagenase (SANTYL®) Ointment
245265|NCT01408277|P2|Participant Flow|Control|Standard Care
245266|NCT01408277|P1|Participant Flow|Santyl|Collagenase (SANTYL®) Ointment
245267|NCT01408277|O2|Outcome|Control|"Control = Standard Care~Standard Care is defined as the standard wound care protocol for chronic wounds used by each Investigator, in their clinic (e.g., wet-to-dry, compression, sharp debridement, etc.)."
245268|NCT01408277|O1|Outcome|Santyl®|Collagenase (Santyl®) Ointment
245269|NCT01408277|E2|Reported Event|Control|Standard Care
245270|NCT01408277|E1|Reported Event|Santyl|Collagense (Santyl®) Ointment
245271|NCT01407575|B3|Baseline|Total|Total of all reporting groups
245272|NCT01407575|B2|Baseline|Placebo|Placebo: matched placebo
245273|NCT01407575|B1|Baseline|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
245274|NCT01407575|P2|Participant Flow|Placebo|Placebo: matched placebo
245275|NCT01407575|P1|Participant Flow|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
245276|NCT01407575|O2|Outcome|Placebo|Placebo: matched placebo
245277|NCT01407575|O1|Outcome|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
245278|NCT01407575|O2|Outcome|Placebo|"matching placebo- sublingual- over the course of 8 weeks~Placebo: matched placebo"
245279|NCT01407575|O1|Outcome|Buprenorphine|"0.2 to 1.6mg of buprenorphine sublingual over the course of 8 weeks~Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)"
245280|NCT01407575|O2|Outcome|Placebo|Placebo: matched placebo
245281|NCT01407575|O1|Outcome|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
245282|NCT01407575|O2|Outcome|Placebo|Placebo: matched placebo
245283|NCT01407575|O1|Outcome|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
245284|NCT01407575|O2|Outcome|Placebo|Placebo: matched placebo
245285|NCT01407575|O1|Outcome|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
245286|NCT01407575|O2|Outcome|Placebo|Placebo: matched placebo
245287|NCT01407575|O1|Outcome|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
245288|NCT01407575|O2|Outcome|Placebo|Placebo: matched placebo
245289|NCT01407575|O1|Outcome|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
245290|NCT01407575|E2|Reported Event|Placebo|Placebo: matched placebo
245291|NCT01407575|E1|Reported Event|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
245292|NCT01407523|B1|Baseline|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
245293|NCT01407523|P1|Participant Flow|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
245294|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
245295|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
245296|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
245297|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
245298|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
245331|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
245750|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
245299|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
245300|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
245301|NCT01407523|E1|Reported Event|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
245302|NCT01407354|B1|Baseline|All Study Participants|Baseline data reflects all participants who received both aquatic exercise and lokomat training during the study.
245303|NCT01407354|P2|Participant Flow|Aquatic Therapy First Then Lokomat Intervention|"Aquatic exercise therapy~Aquatic exercise therapy: Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session, participants received lokomat intervention after aquatic exercise"
245304|NCT01407354|P1|Participant Flow|Lokomat First Then Aquatic Exercise|"Lokomat robotic assisted treadmill training Lokomat Treadmill Training~Lokomat treadmill training: Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session, participants received aquatic exercise after lokomat"
245305|NCT01407354|O2|Outcome|Aquatic Therapy|"Aquatic exercise therapy~Aquatic exercise therapy: Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session"
245306|NCT01407354|O1|Outcome|Lokomat|"Lokomat robotic assisted treadmill training Lokomat Treadmill Training~Lokomat treadmill training: Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session,"
245307|NCT01407354|O2|Outcome|Aquatic Therapy|"Aquatic exercise therapy~Aquatic exercise therapy: Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session"
245308|NCT01407354|O1|Outcome|Lokomat Training|"Lokomat robotic assisted treadmill training Lokomat Treadmill Training~Lokomat treadmill training: Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session"
245309|NCT01407354|E2|Reported Event|Aquatic Therapy|"Aquatic exercise therapy~Aquatic exercise therapy: Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session"
245310|NCT01407354|E1|Reported Event|Lokomat Training|"Lokomat robotic assisted treadmill training Lokomat Treadmill Training~Lokomat treadmill training: Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session"
245311|NCT01407276|B9|Baseline|Total|Total of all reporting groups
245312|NCT01407276|B8|Baseline|Part 2: Control to Match Panel G (Panel H)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel G.
245313|NCT01407276|B7|Baseline|Part 2: ESRD Requiring HD (Panel G)|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD)
245314|NCT01407276|B6|Baseline|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
245315|NCT01407276|B5|Baseline|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
245316|NCT01407276|B4|Baseline|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
245317|NCT01407276|B3|Baseline|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
245318|NCT01407276|B2|Baseline|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
245319|NCT01407276|B1|Baseline|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
245320|NCT01407276|P8|Participant Flow|Part 2: Control to Match Panel G (Panel H)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel G.
245321|NCT01407276|P7|Participant Flow|Part 2: ESRD Requiring HD (Panel G)|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD)
245322|NCT01407276|P6|Participant Flow|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
245323|NCT01407276|P5|Participant Flow|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
245324|NCT01407276|P4|Participant Flow|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
245325|NCT01407276|P3|Participant Flow|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
245326|NCT01407276|P2|Participant Flow|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
245327|NCT01407276|P1|Participant Flow|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
245328|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
245329|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Periods 1 and 2|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G.
245330|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
245464|NCT01406938|B2|Baseline|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
245332|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
245333|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
245334|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
245335|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
245336|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
245337|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Periods 1 and 2|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G.
245338|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
245339|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
245340|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
245341|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
245342|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
245343|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
245344|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
245345|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
245346|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
245347|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD. One participant did not have an estimable parameter.
245348|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
245349|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
245350|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
245351|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
245352|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
245353|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
245354|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
245355|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
245356|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
245357|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD.
245358|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
245359|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
245360|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
245361|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
245362|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
245363|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
245751|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
245364|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
245365|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
245366|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
245367|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
245368|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
245369|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
245370|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
245371|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
245372|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
245373|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
245374|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
245375|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
245376|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
245377|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
245378|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
245379|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
245380|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
245381|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
245382|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
245383|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
245384|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
245385|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD. One participant did not have an estimable parameter.
245386|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
245387|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
245388|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
245389|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
245390|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
245391|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
245392|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from the study was not included.
245393|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
245394|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
245395|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD. One participant did not have an estimable parameter.
245396|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
245397|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
245398|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
245399|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
245400|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
245401|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
245402|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
245403|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
245404|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
245405|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD.
245406|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
245407|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
245408|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
245409|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
245410|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
245411|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
245412|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
245413|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
245414|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
245415|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD.
245416|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
245417|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
245418|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
245419|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
245420|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
245421|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
245422|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
245423|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
245424|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
245425|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD.
245426|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
245427|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
245517|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
245428|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
245429|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
245430|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
245431|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
245432|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
245433|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
245434|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
245435|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD. One participant did not have an estimable parameter.
245436|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
245437|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
245438|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
245439|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
245440|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
245441|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
245442|NCT01407276|E8|Reported Event|Part 2: Control to Match Panel G (Panel H)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
245443|NCT01407276|E7|Reported Event|Part 2: ESRD Requiring HD (Panel G)|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD)
245444|NCT01407276|E6|Reported Event|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
245445|NCT01407276|E5|Reported Event|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
245446|NCT01407276|E4|Reported Event|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
245447|NCT01407276|E3|Reported Event|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
245448|NCT01407276|E2|Reported Event|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
245449|NCT01407276|E1|Reported Event|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
245450|NCT01407068|B1|Baseline|AA4500|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
245451|NCT01407068|P1|Participant Flow|AA4500|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
245452|NCT01407068|O2|Outcome|AA4500 PIP|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand in the interphalangeal (PIP) joint cord"
245453|NCT01407068|O1|Outcome|AA4500 MP|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand in the metacarpophalangeal (MP) joint cord"
245454|NCT01407068|O1|Outcome|AA4500|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
245455|NCT01407068|O1|Outcome|AA4500|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
245456|NCT01407068|O1|Outcome|AA4500|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
245457|NCT01407068|O1|Outcome|AA4500|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
245458|NCT01407068|E1|Reported Event|AA4500|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
245459|NCT01406990|B1|Baseline|Aspirin 81 mg|Women with CAD taking 81 mg aspirin.
245460|NCT01406990|P1|Participant Flow|Aspirin 81 mg|Women with CAD taking 81 mg aspirin.
245461|NCT01406990|O1|Outcome|Aspirin 81 mg|Women with CAD taking 81 mg aspirin.
245462|NCT01406990|E1|Reported Event|Aspirin 81 mg|Women with CAD taking 81 mg aspirin.
245463|NCT01406938|B3|Baseline|Total|Total of all reporting groups
245465|NCT01406938|B1|Baseline|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
245466|NCT01406938|P6|Participant Flow|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
245467|NCT01406938|P5|Participant Flow|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
245468|NCT01406938|P4|Participant Flow|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
245469|NCT01406938|P3|Participant Flow|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
245470|NCT01406938|P2|Participant Flow|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
245471|NCT01406938|P1|Participant Flow|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
245472|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
245473|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
245474|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
245475|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
245476|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
245477|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
245478|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
245479|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
245480|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
245481|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
245482|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
245483|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
245484|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
245485|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
245486|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
245487|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
245488|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
245489|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
245490|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
245491|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
245492|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
245493|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
245494|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
245495|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
245496|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
245497|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
245498|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
245499|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
245500|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
245501|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
245502|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
245503|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
245504|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
245505|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
245506|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
245507|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
245508|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
245509|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
245510|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
245511|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
245512|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
245513|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
245514|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
245515|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
245516|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
264010|NCT01348087|E2|Reported Event|AFQ056 25 mg Bid|AFQ056 25 mg bid
245519|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
245520|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
245521|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
245522|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
245523|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
245524|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
245525|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
245526|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
245527|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
245528|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
245529|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
245530|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
245531|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
245532|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
245533|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
245534|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
245535|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
245536|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
245537|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
245538|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
245539|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
245540|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
245541|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
245542|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
245543|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
245544|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
245545|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
245546|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
245547|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
245548|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
245549|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
245550|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
245551|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
245552|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
245553|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
245554|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
245555|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
245556|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
245557|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
245558|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
245559|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
245560|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
245561|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
245562|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
245563|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
245564|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
245565|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
245566|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
245567|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
245568|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
245569|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
245570|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
245571|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
245573|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
245574|NCT01406938|E12|Reported Event|FOLLOW UP-AIN457 300 mg SoR|FOLLOW UP-AIN457 300 mg SoR
245575|NCT01406938|E11|Reported Event|FOLLOW UP-AIN457 150 mg SoR|FOLLOW UP-AIN457 150 mg SoR
245576|NCT01406938|E10|Reported Event|FOLLOW UP-AIN457 300 mg|FOLLOW UP-AIN457 300 mg
245577|NCT01406938|E9|Reported Event|FOLLOW UP-AIN457 150 mg|FOLLOW UP-AIN457 150 mg
245578|NCT01406938|E8|Reported Event|FOLLOW UP-AIN457 300mg IPO|FOLLOW UP-AIN457 300mg IPO
245579|NCT01406938|E7|Reported Event|FOLLOW UP-AIN457 150mg IPO|FOLLOW UP-AIN457 150mg IPO
245580|NCT01406938|E6|Reported Event|ENTIRE-AIN457 300 mg SoR|ENTIRE-AIN457 300 mg SoR
245581|NCT01406938|E5|Reported Event|ENTIRE-AIN457 150 mg SoR|ENTIRE-AIN457 150 mg SoR
245582|NCT01406938|E4|Reported Event|ENTIRE-AIN457 300mg|ENTIRE-AIN457 300mg
245583|NCT01406938|E3|Reported Event|ENTIRE-AIN457 150mg|ENTIRE-AIN457 150mg
245584|NCT01406938|E2|Reported Event|INDUCTION-AIN457 300mg|INDUCTION-AIN457 300mg
245585|NCT01406938|E1|Reported Event|INDUCTION-AIN457 150mg|INDUCTION-AIN457 150mg
245586|NCT01406873|B3|Baseline|Total|Total of all reporting groups
245587|NCT01406873|B2|Baseline|Placebo|This group received 150 mg/kg placebo capsules taken by mouth, three times daily for 6 months
245588|NCT01406873|B1|Baseline|Mexiletine|This group received 150 mg/kg Mexiletine capsules taken by mouth, three times daily for 6 months
245589|NCT01406873|P2|Participant Flow|Placebo|This group received 150 mg/kg placebo capsules taken by mouth, three times daily for 6 months
245590|NCT01406873|P1|Participant Flow|Mexiletine|This group received 150 mg/kg Mexiletine capsules taken by mouth, three times daily for 6 months
245591|NCT01406873|O2|Outcome|Placebo|Mean Change from Baseline in Patient-Reported Disease Burden and Quality of Life for Patients who Received Placebo (150 mg/kg capsules taken by mouth, three times daily for 6 months)
245592|NCT01406873|O1|Outcome|Mexiletine|Mean Change from Baseline in Patient-Reported Disease Burden and Quality of Life for Patients who Received Mexiletine (150 mg/kg capsules taken by mouth, three times daily for 6 months)
245593|NCT01406873|O2|Outcome|Placebo|This group received 150 mg/kg placebo capsules taken by mouth, three times daily for 6 months
245594|NCT01406873|O1|Outcome|Mexiletine|This group received 150 mg/kg Mexiletine capsules taken by mouth, three times daily for 6 months
245595|NCT01406873|O2|Outcome|Placebo|Mean Change from Baseline in Manual Muscle Testing (MMT) Score for Patients who Received Placebo (150 mg/kg capsules taken by mouth, three times daily for 6 months)
245596|NCT01406873|O1|Outcome|Mexiletine|Mean Change from Baseline in Manual Muscle Testing (MMT) Score for Patients who Received Mexiletine (150 mg/kg capsules taken by mouth, three times daily for 6 months)
245597|NCT01406873|O2|Outcome|Placebo|Mean Change from Baseline in Quantitative Measure of Hand Grip Myotonia for Patients who Received Placebo (150 mg/kg capsules taken by mouth, three times daily for 6 months)
245598|NCT01406873|O1|Outcome|Mexiletine|Mean Change from Baseline in Quantitative Measure of Hand Grip Myotonia for Patients who Received Mexiletine (150 mg/kg capsules taken by mouth, three times daily for 6 months)
245599|NCT01406873|O2|Outcome|Placebo|Percentage of Participants that had a dose Reduction or a Study Drug Withdrawal or Suspension for Patients who Received Placebo (150 mg/kg capsules taken by mouth, three times daily for 6 months)
245600|NCT01406873|O1|Outcome|Mexiletine|Percentage of Participants that had a dose Reduction or a Study Drug Withdrawal or Suspension for Patients who Received Mexiletine (150 mg/kg capsules taken by mouth, three times daily for 6 months)
245601|NCT01406873|O2|Outcome|Placebo|Mean Change from Baseline in Ambulation using the 6 Minute Walk Test in Patients who Received Placebo (150 mg/kg capsules taken by mouth, three times daily for 6 months)
245602|NCT01406873|O1|Outcome|Mexiletine|Mean Change from Baseline in Ambulation using the 6 Minute Walk Test in Patients who Received Mexiletine (150 mg/kg capsules taken by mouth, three times daily for 6 months)
245603|NCT01406873|E2|Reported Event|Placebo|Adverse Events for Patients who Received Placebo (150 mg/kg capsules taken by mouth, three times daily for 6 months)
245604|NCT01406873|E1|Reported Event|Mexiletine|Adverse Events for Patients who Received Mexiletine (150 mg/kg capsules taken by mouth, three times daily for 6 months)
245605|NCT01406860|B3|Baseline|Total|Total of all reporting groups
245606|NCT01406860|B2|Baseline|Metoclopramide + Diphenhydramine|"Metoclopramide: Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses.~Diphenhydramine: Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion."
245607|NCT01406860|B1|Baseline|Droperidol|Droperidol: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes
245608|NCT01406860|P2|Participant Flow|Metoclopramide + Diphenhydramine|Metoclopramide: Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses + Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion.
245609|NCT01406860|P1|Participant Flow|Droperidol|Droperidol: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes
245610|NCT01406860|O2|Outcome|Metoclopramide|Metoclopramide: Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses + Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion.
245611|NCT01406860|O1|Outcome|Droperidol|Droperidol: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes
245612|NCT01406860|O2|Outcome|Metoclopramide|Metoclopramide: Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses + Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion.
245613|NCT01406860|O1|Outcome|Droperidol|Droperidol: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes
245614|NCT01406860|O2|Outcome|Metoclopramide|Metoclopramide: Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses + Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion.
245615|NCT01406860|O1|Outcome|Droperidol|Droperidol: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes
245616|NCT01406860|O2|Outcome|Metoclopramide + Diphenhydramine|"Metoclopramide: Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses.~Diphenhydramine: Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion."
245617|NCT01406860|O1|Outcome|Droperidol|Droperidol: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes
245618|NCT01406860|E2|Reported Event|Metoclopramide|"Metoclopramide: Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses.~Diphenhydramine: Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion."
245619|NCT01406860|E1|Reported Event|Droperidol|Droperidol: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes
245620|NCT01406795|B1|Baseline|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
245621|NCT01406795|P1|Participant Flow|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
245622|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
245623|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
245624|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
245625|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
245626|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
245627|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
245628|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
245629|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
245630|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
245631|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
245632|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
245633|NCT01406795|E1|Reported Event|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
245634|NCT01406574|B1|Baseline|OPB-31121|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
245635|NCT01406574|P4|Participant Flow|OPB-31121: 400mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
245636|NCT01406574|P3|Participant Flow|OPB-31121: 200mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
245637|NCT01406574|P2|Participant Flow|OPB-31121: 100mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
245638|NCT01406574|P1|Participant Flow|OPB-31121: 50mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
245639|NCT01406574|O1|Outcome|OPB-31121|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
245640|NCT01406574|O4|Outcome|OPB-31121: 400 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
245641|NCT01406574|O3|Outcome|OPB-31121: 200 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
245642|NCT01406574|O2|Outcome|OPB-31121: 100 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
245643|NCT01406574|O1|Outcome|OPB-31121: 50 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
245644|NCT01406574|O1|Outcome|OPB-31121|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
245645|NCT01406574|E4|Reported Event|OPB-31121: 400 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
245646|NCT01406574|E3|Reported Event|OPB-31121: 200 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
245647|NCT01406574|E2|Reported Event|OPB-31121: 100 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
245648|NCT01406574|E1|Reported Event|OPB-31121: 50 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
245649|NCT01406223|B5|Baseline|Total|Total of all reporting groups
245650|NCT01406223|B4|Baseline|Post-quit NRT|"Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.~Nicotine patches~Placebo varenicline~Placebo bupropion~Placebo patch"
245651|NCT01406223|B3|Baseline|Varenicline + Bupropion|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches.~Varenicline~Bupropion~Nicotine patches~Placebo patch"
245652|NCT01406223|B2|Baseline|NRT (Nicotine Patches Only)|"21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.~Nicotine patches~Placebo varenicline~Placebo bupropion"
245653|NCT01406223|B1|Baseline|Varenicline|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches.~Varenicline~Nicotine patches~Placebo bupropion~Placebo patch"
245654|NCT01406223|P4|Participant Flow|Post-quit NRT|"Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.~Nicotine patches~Placebo varenicline~Placebo bupropion~Placebo patch"
245655|NCT01406223|P3|Participant Flow|Varenicline + Bupropion|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches.~Varenicline~Bupropion~Nicotine patches~Placebo patch"
245656|NCT01406223|P2|Participant Flow|NRT (Nicotine Patches Only)|"21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.~Nicotine patches~Placebo varenicline~Placebo bupropion"
245657|NCT01406223|P1|Participant Flow|Varenicline|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches.~Varenicline~Nicotine patches~Placebo bupropion~Placebo patch"
245658|NCT01406223|O4|Outcome|Post-quit NRT|"Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.~Nicotine patches~Placebo varenicline~Placebo bupropion~Placebo patch"
245659|NCT01406223|O3|Outcome|Varenicline + Bupropion|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches.~Varenicline~Bupropion~Nicotine patches~Placebo patch"
245660|NCT01406223|O2|Outcome|NRT (Nicotine Patches Only)|"21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.~Nicotine patches~Placebo varenicline~Placebo bupropion"
245705|NCT01405937|B2|Baseline|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
245706|NCT01405937|B1|Baseline|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
245661|NCT01406223|O1|Outcome|Varenicline|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches.~Varenicline~Nicotine patches~Placebo bupropion~Placebo patch"
245662|NCT01406223|O4|Outcome|Post-quit NRT|"Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.~Nicotine patches~Placebo varenicline~Placebo bupropion~Placebo patch"
245663|NCT01406223|O3|Outcome|Varenicline + Bupropion|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches.~Varenicline~Bupropion~Nicotine patches~Placebo patch"
245664|NCT01406223|O2|Outcome|NRT (Nicotine Patches Only)|"21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.~Nicotine patches~Placebo varenicline~Placebo bupropion"
245665|NCT01406223|O1|Outcome|Varenicline|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches.~Varenicline~Nicotine patches~Placebo bupropion~Placebo patch"
245666|NCT01406223|E4|Reported Event|Post-quit NRT|"Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.~Nicotine patches~Placebo varenicline~Placebo bupropion~Placebo patch"
245667|NCT01406223|E3|Reported Event|Varenicline + Bupropion|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches.~Varenicline~Bupropion~Nicotine patches~Placebo patch"
245668|NCT01406223|E2|Reported Event|NRT (Nicotine Patches Only)|"21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.~Nicotine patches~Placebo varenicline~Placebo bupropion"
245669|NCT01406223|E1|Reported Event|Varenicline|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches.~Varenicline~Nicotine patches~Placebo bupropion~Placebo patch"
245670|NCT01406015|B3|Baseline|Total|Total of all reporting groups
245671|NCT01406015|B2|Baseline|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
245672|NCT01406015|B1|Baseline|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
245673|NCT01406015|P2|Participant Flow|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
245674|NCT01406015|P1|Participant Flow|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
245675|NCT01406015|O2|Outcome|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
245676|NCT01406015|O1|Outcome|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
245677|NCT01406015|O2|Outcome|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
245678|NCT01406015|O1|Outcome|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
245679|NCT01406015|O2|Outcome|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
245680|NCT01406015|O1|Outcome|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
245681|NCT01406015|O2|Outcome|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
245682|NCT01406015|O1|Outcome|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
245683|NCT01406015|O2|Outcome|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
245684|NCT01406015|O1|Outcome|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
245685|NCT01406015|E2|Reported Event|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
245686|NCT01406015|E1|Reported Event|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
245687|NCT01405950|B3|Baseline|Total|Total of all reporting groups
245688|NCT01405950|B2|Baseline|Dose Level 2|Zanaflex Capsules : 0.05 mg/kg
245689|NCT01405950|B1|Baseline|Dose Level 1|Zanaflex Capsules : 0.025 mg/kg
245690|NCT01405950|P4|Participant Flow|Dose Level 4|Zanaflex Capsules : 0.1 mg/kg
245691|NCT01405950|P3|Participant Flow|Dose Level 3|Zanaflex Capsules : 0.075 mg/kg
245692|NCT01405950|P2|Participant Flow|Dose Level 2|Zanaflex Capsules : 0.05 mg/kg
245693|NCT01405950|P1|Participant Flow|Dose Level 1|Zanaflex Capsules : 0.025 mg/kg
245694|NCT01405950|O4|Outcome|Dose Level 4|Zanaflex Capsules: 0.1 mg/kg
245695|NCT01405950|O3|Outcome|Dose Level 3|Zanaflex Capsules: 0.075 mg/kg
245696|NCT01405950|O2|Outcome|Dose Level 2|Zanaflex Capsules : 0.05 mg/kg
245707|NCT01405937|P2|Participant Flow|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
245708|NCT01405937|P1|Participant Flow|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
245709|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
245710|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
245711|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
245712|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
245713|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
245714|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
245715|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
245716|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
245717|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
245718|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
245719|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
245720|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
245721|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
245722|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
245723|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
245724|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
245725|NCT01405937|E2|Reported Event|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
245726|NCT01405937|E1|Reported Event|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
245727|NCT01405924|B1|Baseline|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
245728|NCT01405924|P1|Participant Flow|Fosaprepitant 150 mg|Women with breast cancer receiving anthracycline-cyclophosphamide (AC)-like chemotherapy and women with gynecological cancer receiving carboplatin-paclitaxel (CT) chemotherapy receive fosaprepitant 150 mg administered intravenously (IV) on Day 1 of Cycle 2 of chemotherapy
245729|NCT01405924|O1|Outcome|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
245730|NCT01405924|O1|Outcome|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
245731|NCT01405924|O1|Outcome|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
245732|NCT01405924|O1|Outcome|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
245733|NCT01405924|O2|Outcome|Fosaprepitant 150 mg: CT Chemotherapy|Women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
245734|NCT01405924|O1|Outcome|Fosaprepitant 150 mg: AC-like Chemotherapy|Women with breast cancer receiving AC-like chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
245735|NCT01405924|O1|Outcome|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
245736|NCT01405924|E1|Reported Event|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
245737|NCT01405898|B3|Baseline|Total|Total of all reporting groups
245738|NCT01405898|B2|Baseline|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
245739|NCT01405898|B1|Baseline|Beetroot Juice|Beetroot juice 4 weeks 250ml daily
245740|NCT01405898|P2|Participant Flow|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
245741|NCT01405898|P1|Participant Flow|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
245742|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
245743|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
245752|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
245753|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
245754|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
245755|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
245756|NCT01405898|E2|Reported Event|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
245757|NCT01405898|E1|Reported Event|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
245758|NCT01405820|B7|Baseline|Total|Total of all reporting groups
245759|NCT01405820|B6|Baseline|Randomized Period: Natalizumab 150 mg SC Every 12 Weeks|Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
245760|NCT01405820|B5|Baseline|Randomized Period: Natalizumab 150 mg IV Every 12 Weeks|Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
245761|NCT01405820|B4|Baseline|Randomized Period: Natalizumab 300 mg SC Every 12 Weeks|Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
245762|NCT01405820|B3|Baseline|Randomized Period: Natalizumab 300 mg IV Every 12 Weeks|Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
245763|NCT01405820|B2|Baseline|Randomized Period: Natalizumab 300 mg SC Every 4 Weeks|Natalizumab 300 mg SC every 4 weeks for 60 weeks.
245764|NCT01405820|B1|Baseline|Randomized Period: Natalizumab 300 mg IV Every 4 Weeks|Natalizumab 300 mg IV every 4 weeks for 60 weeks.
245765|NCT01405820|P6|Participant Flow|Natalizumab 150 mg SC Every 12 Weeks|Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
245766|NCT01405820|P5|Participant Flow|Natalizumab 150 mg IV Every 12 Weeks|Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
245767|NCT01405820|P4|Participant Flow|Natalizumab 300 mg SC Every 12 Weeks|Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
245768|NCT01405820|P3|Participant Flow|Natalizumab 300 mg IV Every 12 Weeks|Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
245769|NCT01405820|P2|Participant Flow|Natalizumab 300 mg Subcutaneous (SC) Every 4 Weeks|Natalizumab 300 mg SC every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
245770|NCT01405820|P1|Participant Flow|Natalizumab 300 mg Intravenous (IV) Every 4 Weeks|Natalizumab 300 mg IV every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
245771|NCT01405820|O6|Outcome|Randomized Period: Natalizumab 150 mg SC Every 12 Weeks|Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
245772|NCT01405820|O5|Outcome|Randomized Period: Natalizumab 150 mg IV Every 12 Weeks|Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
245773|NCT01405820|O4|Outcome|Randomized Period: Natalizumab 300 mg SC Every 12 Weeks|Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
245774|NCT01405820|O3|Outcome|Randomized Period: Natalizumab 300 mg IV Every 12 Weeks|Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
245775|NCT01405820|O2|Outcome|Randomized Period: Natalizumab 300 mg SC Every 4 Weeks|Natalizumab 300 mg SC every 4 weeks for 60 weeks.
245776|NCT01405820|O1|Outcome|Randomized Period: Natalizumab 300 mg IV Every 4 Weeks|Natalizumab 300 mg IV every 4 weeks for 60 weeks.
245777|NCT01405820|E12|Reported Event|Open-label Period: Natalizumab 150 mg SC Every 12 Weeks|Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
245778|NCT01405820|E11|Reported Event|Open-label Period: Natalizumab 150 mg IV Every 12 Weeks|Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
245779|NCT01405820|E10|Reported Event|Open-label Period: Natalizumab 300 mg SC Every 12 Weeks|Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
245780|NCT01405820|E9|Reported Event|Open-label Period: Natalizumab 300 mg IV Every 12 Weeks|Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
245781|NCT01405820|E8|Reported Event|Open-label Period: Natalizumab 300 mg SC Every 4 Weeks|Natalizumab 300 mg SC every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
245782|NCT01405820|E7|Reported Event|Open-label Period: Natalizumab 300 mg IV Every 4 Weeks|Natalizumab 300 mg IV every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
245783|NCT01405820|E6|Reported Event|Randomized Period: Natalizumab 150 mg SC Every 12 Weeks|Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
245784|NCT01405820|E5|Reported Event|Randomized Period: Natalizumab 150 mg IV Every 12 Weeks|Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
245785|NCT01405820|E4|Reported Event|Randomized Period: Natalizumab 300 mg SC Every 12 Weeks|Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
245786|NCT01405820|E3|Reported Event|Randomized Period: Natalizumab 300 mg IV Every 12 Weeks|Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
245787|NCT01405820|E2|Reported Event|Randomized Period: Natalizumab 300 mg SC Every 4 Weeks|Natalizumab 300 mg SC every 4 weeks for 60 weeks.
245788|NCT01405820|E1|Reported Event|Randomized Period: Natalizumab 300 mg IV Every 4 Weeks|Natalizumab 300 mg IV every 4 weeks for 60 weeks.
245789|NCT01405794|B1|Baseline|All Participants|
245790|NCT01405794|P1|Participant Flow|All Study Participants|All participants were dosed with the placebo (14 days), then they all had a 72hr washout period. Last all participants were dosed with the 32ppm Oral Silver for (14 days).
245791|NCT01405794|O2|Outcome|32ppm Oral Silver|
245792|NCT01405794|O1|Outcome|Placebo|
245793|NCT01405794|O2|Outcome|32ppm Oral Silver|
245794|NCT01405794|O1|Outcome|Placebo|
245795|NCT01405794|O2|Outcome|32ppm Oral Silver|
245796|NCT01405794|O1|Outcome|Placebo|
245797|NCT01405794|O2|Outcome|32ppm Oral Silver|
245798|NCT01405794|O1|Outcome|Placebo|
245799|NCT01405794|O2|Outcome|32ppm Oral Silver|
245800|NCT01405794|O1|Outcome|Placebo|
245801|NCT01405794|O2|Outcome|32ppm Oral Silver|
245802|NCT01405794|O1|Outcome|Placebo|
245803|NCT01405794|O2|Outcome|32ppm Oral Silver|
245804|NCT01405794|O1|Outcome|Placebo|
245805|NCT01405794|O2|Outcome|32ppm Oral Silver|
245806|NCT01405794|O1|Outcome|Placebo|
245807|NCT01405794|O2|Outcome|32ppm Oral Silver|
245808|NCT01405794|O1|Outcome|Placebo|
245809|NCT01405794|O2|Outcome|32ppm Oral Silver|
245810|NCT01405794|O1|Outcome|Placebo|
245811|NCT01405794|O2|Outcome|32ppm Oral Silver|
245812|NCT01405794|O1|Outcome|Placebo|
245813|NCT01405794|O2|Outcome|32ppm Oral Silver|
245814|NCT01405794|O1|Outcome|Placebo|
245815|NCT01405794|O2|Outcome|32ppm Oral Silver|
245816|NCT01405794|O1|Outcome|Placebo|
245817|NCT01405794|O2|Outcome|32ppm Oral Silver|
245818|NCT01405794|O1|Outcome|Placebo|
245819|NCT01405794|O2|Outcome|32ppm Oral Silver|
245820|NCT01405794|O1|Outcome|Placebo|
245821|NCT01405794|O2|Outcome|32ppm Oral Silver|
245822|NCT01405794|O1|Outcome|Placebo|
245823|NCT01405794|O2|Outcome|32ppm Oral Silver|
245824|NCT01405794|O1|Outcome|Placebo|
245825|NCT01405794|O2|Outcome|32ppm Oral Silver|
245826|NCT01405794|O1|Outcome|Placebo|
245827|NCT01405794|O2|Outcome|32ppm Oral Silver|
245828|NCT01405794|O1|Outcome|Placebo|
245829|NCT01405794|O2|Outcome|32ppm Oral Silver|
245830|NCT01405794|O1|Outcome|Placebo|
245831|NCT01405794|O2|Outcome|32ppm Oral Silver|
245832|NCT01405794|O1|Outcome|Placebo|
245833|NCT01405794|O2|Outcome|32ppm Oral Silver|
245834|NCT01405794|O1|Outcome|Placebo|
245835|NCT01405794|O2|Outcome|32ppm Oral Silver|
245836|NCT01405794|O1|Outcome|Placebo|
245837|NCT01405794|O2|Outcome|32ppm Oral Silver|
245838|NCT01405794|O1|Outcome|Placebo|
245839|NCT01405794|O2|Outcome|32ppm Oral Silver|
245840|NCT01405794|O1|Outcome|Placebo|
245841|NCT01405794|O2|Outcome|32ppm Oral Silver|
245842|NCT01405794|O1|Outcome|Placebo|
245843|NCT01405794|O2|Outcome|32ppm Oral Silver|
245844|NCT01405794|O1|Outcome|Placebo|
245845|NCT01405794|O2|Outcome|32ppm Oral Silver|
245846|NCT01405794|O1|Outcome|Placebo|
245847|NCT01405794|O2|Outcome|32ppm Oral Silver|
245848|NCT01405794|O1|Outcome|Placebo|
245849|NCT01405794|O2|Outcome|32ppm Oral Silver|
245850|NCT01405794|O1|Outcome|Placebo|
245851|NCT01405794|O2|Outcome|32ppm Oral Silver|
245852|NCT01405794|O1|Outcome|Placebo|
245853|NCT01405794|O2|Outcome|32ppm Oral Silver|
245854|NCT01405794|O1|Outcome|Placebo|
245855|NCT01405794|O2|Outcome|32ppm Oral Silver|
245856|NCT01405794|O1|Outcome|Placebo|
245857|NCT01405794|O2|Outcome|32ppm Oral Silver|
245858|NCT01405794|O1|Outcome|Placebo|
245859|NCT01405794|O2|Outcome|32ppm Oral Silver|
245860|NCT01405794|O1|Outcome|Placebo|
245861|NCT01405794|E2|Reported Event|Silver Biotics 32 Ppm Diluent|
245862|NCT01405794|E1|Reported Event|ASAP 32 Ppm Solution Experimental|
245863|NCT01405768|B3|Baseline|Total|Total of all reporting groups
245864|NCT01405768|B2|Baseline|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.~sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
245865|NCT01405768|B1|Baseline|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
245866|NCT01405768|P2|Participant Flow|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.~sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
245867|NCT01405768|P1|Participant Flow|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
245868|NCT01405768|O2|Outcome|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.~sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
245869|NCT01405768|O1|Outcome|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
245870|NCT01405768|O2|Outcome|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.~sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
265238|NCT01344460|O2|Outcome|Unenhanced MRA|
245871|NCT01405768|O1|Outcome|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
245872|NCT01405768|O2|Outcome|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.~sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
245873|NCT01405768|O1|Outcome|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
245874|NCT01405768|O2|Outcome|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.~sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
245875|NCT01405768|O1|Outcome|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
245876|NCT01405768|E2|Reported Event|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.~sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
245877|NCT01405768|E1|Reported Event|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
245878|NCT01405742|B1|Baseline|Severe Hemophilia A|Subjects will be randomized to receive either once-weekly F.VIII at 40 IU/kg (Arm A) or thrice-weekly F.VIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will undergo “Cross-Over”, that is, switch to the alternative Study Arm for the last 26 weeks, following a 72 hour washout period.
245879|NCT01405742|P2|Participant Flow|Thrice-Weekly Then Once-Weekly FVIII|Subjects randomized to receive either once-weekly F.VIII at 40 IU/kg (Arm A) or thrice-weekly F.VIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will undergo “Cross-Over”, that is, switch to the alternative Study Arm for the last 26 weeks, following a 72 hour washout period. Group 1, will receive Arm A for the first 26 weeks, and Arm B for the last 26 weeks. Group 2, will receive Arm B for the first 26 weeks and Arm A for the last 26 weeks.
245880|NCT01405742|P1|Participant Flow|Once-Weekly Then Thrice-Weekly FVIII|Subjects randomized to receive either once-weekly F.VIII at 40 IU/kg (Arm A) or thrice-weekly F.VIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will undergo “Cross-Over”, that is, switch to the alternative Study Arm for the last 26 weeks, following a 72 hour washout period. Group 1, will receive Arm A for the first 26 weeks, and Arm B for the last 26 weeks. Group 2, will receive Arm B for the first 26 weeks and Arm A for the last 26 weeks.
245881|NCT01405742|O2|Outcome|Thrice Weekly FVIII|Subjects will be randomized to receive thrice-weekly FVIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will cross-over to once-weekly FVIII at 40 IU/kg (Arm A) for weeks 26-52, following a 72 hour washout period.
245882|NCT01405742|O1|Outcome|Once Weekly FVIII|Subjects will be randomized to receive once-weekly FVIII at 40 IU/kg (Arm A) for the first 26 weeks. Then at 26 weeks, they will cross-over to thrice-weekly FVIII at 40 IU/kg (Arm B) for weeks 26-52, following a 72 hour washout period.
245883|NCT01405742|O2|Outcome|Thrice Weekly FVIII|Subjects will be randomized to receive thrice-weekly FVIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will cross-over to once-weekly FVIII at 40 IU/kg (Arm A) for weeks 26-52, following a 72 hour washout period.
245884|NCT01405742|O1|Outcome|Once Weekly FVIII|Subjects will be randomized to receive once-weekly FVIII at 40 IU/kg (Arm A) for the first 26 weeks. Then at 26 weeks, they will cross-over to thrice-weekly FVIII at 40 IU/kg (Arm B) for weeks 26-52, following a 72 hour washout period.
245885|NCT01405742|O2|Outcome|Thrice Weekly FVIII|Subjects will be randomized to receive thrice-weekly FVIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will cross-over to once-weekly FVIII at 40 IU/kg (Arm A) for weeks 26-52, following a 72 hour washout period.
245886|NCT01405742|O1|Outcome|Once Weekly FVIII|Subjects will be randomized to receive once-weekly FVIII at 40 IU/kg (Arm A) for the first 26 weeks. Then at 26 weeks, they will cross-over to thrice-weekly FVIII at 40 IU/kg (Arm B) for weeks 26-52, following a 72 hour washout period.
245887|NCT01405742|E2|Reported Event|Arm B Thrice-weekly F.VIII at 40 IU/kg|Subjects will be randomized to receive thrice-weekly F.VIII at 40 IU/kg for the first 26 weeks of study. Then, at 26 weeks, they will undergo “Cross-Over”, that is, switch to the alternative Study Arm (once-weekly) for the last 26 weeks, following a 72 hour washout period.
245888|NCT01405742|E1|Reported Event|Arm A Once-weekly F.VIII at 40 IU/kg|Subjects in Arm A will be randomized to receive either once-weekly F.VIII at 40 IU/kg for the first 26 weeks of study. Then, at 26 weeks, they will undergo “Cross-Over”, that is, switch to the alternative Study Arm (thrice-weekly) for the last 26 weeks, following a 72 hour washout period.
245889|NCT01405560|B1|Baseline|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
245890|NCT01405560|P1|Participant Flow|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
245891|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
245892|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
245893|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
245894|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
245895|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
245896|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
245897|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
246739|NCT01402102|B2|Baseline|Placebo|Oral intake placebo(6.0g/day) for 12weeks
245898|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
245899|NCT01405560|E1|Reported Event|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
245900|NCT01405508|B5|Baseline|Total Title|
245901|NCT01405508|B4|Baseline|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
245902|NCT01405508|B3|Baseline|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
245903|NCT01405508|B2|Baseline|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
245904|NCT01405508|B1|Baseline|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
245905|NCT01405508|P4|Participant Flow|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
245906|NCT01405508|P3|Participant Flow|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
245907|NCT01405508|P2|Participant Flow|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
245908|NCT01405508|P1|Participant Flow|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
245909|NCT01405508|O4|Outcome|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
245910|NCT01405508|O3|Outcome|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
245948|NCT01405456|O2|Outcome|Placebo and Lifestyle|"First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification~placebo and lifestyle: placebo pill daily and lifestyle counseling"
245972|NCT01405313|O2|Outcome|Conventional ASV AHI|1 night of conventional ASV therapy with full polysomnography measurements
245911|NCT01405508|O2|Outcome|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
245912|NCT01405508|O1|Outcome|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
245913|NCT01405508|O4|Outcome|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
245914|NCT01405508|O3|Outcome|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
245915|NCT01405508|O2|Outcome|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
245916|NCT01405508|O1|Outcome|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
245917|NCT01405508|O4|Outcome|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
245918|NCT01405508|O3|Outcome|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
245919|NCT01405508|O2|Outcome|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
245920|NCT01405508|O1|Outcome|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
245921|NCT01405508|E4|Reported Event|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
245949|NCT01405456|O1|Outcome|Eplerenone and Lifestyle|"First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)~Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling"
245922|NCT01405508|E3|Reported Event|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
245923|NCT01405508|E2|Reported Event|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
245924|NCT01405508|E1|Reported Event|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
245925|NCT01405469|B1|Baseline|POEM Patients|pilot study, first 16 patients who received POEM for treatment of achalasia
245926|NCT01405469|P1|Participant Flow|POEM Patients|pilot group of achalasia patients who received POEM Treatment: Endoscopic Myotomy of the Lower Esophageal Sphincter
245927|NCT01405469|O1|Outcome|POEM Patients|pilot study, first 16 patients who received POEM for treatment of achalasia
245928|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
245929|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
245930|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
245931|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
245932|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
245933|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
245934|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
245935|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
245936|NCT01405469|E1|Reported Event|POEM Patients|pilot group of achalasia patients who received POEM treatment
245937|NCT01405456|B3|Baseline|Total|Total of all reporting groups
245938|NCT01405456|B2|Baseline|Placebo and Lifestyle|"First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification~placebo and lifestyle: placebo pill daily and lifestyle counseling"
245939|NCT01405456|B1|Baseline|Eplerenone and Lifestyle|"First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)~Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling"
245940|NCT01405456|P2|Participant Flow|Placebo and Lifestyle|"First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification~placebo and lifestyle: placebo pill daily and lifestyle counseling"
245941|NCT01405456|P1|Participant Flow|Eplerenone and Lifestyle|"First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)~Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling"
245942|NCT01405456|O2|Outcome|Placebo and Lifestyle|"First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification~placebo and lifestyle: placebo pill daily and lifestyle counseling"
245943|NCT01405456|O1|Outcome|Eplerenone and Lifestyle|"First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)~Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling"
245944|NCT01405456|O2|Outcome|Placebo and Lifestyle|"First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification~placebo and lifestyle: placebo pill daily and lifestyle counseling"
245945|NCT01405456|O1|Outcome|Eplerenone and Lifestyle|"First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)~Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling"
245946|NCT01405456|O2|Outcome|Placebo and Lifestyle|"First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification~placebo and lifestyle: placebo pill daily and lifestyle counseling"
245947|NCT01405456|O1|Outcome|Eplerenone and Lifestyle|"First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)~Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling"
246140|NCT01404611|P1|Participant Flow|DF289|"Ear drops~DF289: Ear drops"
245950|NCT01405456|O2|Outcome|Placebo and Lifestyle|"First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification~placebo and lifestyle: placebo pill daily and lifestyle counseling"
245951|NCT01405456|O1|Outcome|Eplerenone and Lifestyle|"First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)~Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling"
245952|NCT01405456|O2|Outcome|Placebo and Lifestyle|"First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification~placebo and lifestyle: placebo pill daily and lifestyle counseling"
245953|NCT01405456|O1|Outcome|Eplerenone and Lifestyle|"First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)~Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling"
245954|NCT01405456|O2|Outcome|Placebo and Lifestyle|"First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification~placebo and lifestyle: placebo pill daily and lifestyle counseling"
245955|NCT01405456|O1|Outcome|Eplerenone and Lifestyle|"First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)~Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling"
245956|NCT01405456|O2|Outcome|Placebo and Lifestyle|"First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification~placebo and lifestyle: placebo pill daily and lifestyle counseling"
245957|NCT01405456|O1|Outcome|Eplerenone and Lifestyle|"First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)~Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling"
245958|NCT01405456|O2|Outcome|Placebo and Lifestyle|"First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification~placebo and lifestyle: placebo pill daily and lifestyle counseling"
245959|NCT01405456|O1|Outcome|Eplerenone and Lifestyle|"First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)~Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling"
245960|NCT01405456|O2|Outcome|Placebo and Lifestyle|"First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification~placebo and lifestyle: placebo pill daily and lifestyle counseling"
245961|NCT01405456|O1|Outcome|Eplerenone and Lifestyle|"First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)~Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling"
245962|NCT01405456|O2|Outcome|Placebo and Lifestyle|"First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification~placebo and lifestyle: placebo pill daily and lifestyle counseling"
245963|NCT01405456|O1|Outcome|Eplerenone and Lifestyle|"First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)~Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling"
245964|NCT01405456|O2|Outcome|Placebo and Lifestyle|"First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification~placebo and lifestyle: placebo pill daily and lifestyle counseling"
245965|NCT01405456|O1|Outcome|Eplerenone and Lifestyle|"First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)~Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling"
245966|NCT01405456|E2|Reported Event|Placebo and Lifestyle|"First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification~placebo and lifestyle: placebo pill daily and lifestyle counseling"
245967|NCT01405456|E1|Reported Event|Eplerenone and Lifestyle|"First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)~Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling"
245968|NCT01405313|B1|Baseline|Modified ASV/Conventional ASV|Therapy used was Modified ASV and then Conventional ASV
245969|NCT01405313|P1|Participant Flow|First Modified ASV Then Conventional ASV|Patients receive Modified ASV algorithm as therapy for 1 night, then Conventional ASV for 1 night
245970|NCT01405313|O2|Outcome|Conventional ASV ODI|1 night of conventional ASV therapy with full polysomnography measurements
245971|NCT01405313|O1|Outcome|Modified ASV ODI|1 night of modified ASV therapy with full polysomnography measurements
245973|NCT01405313|O1|Outcome|Modified ASV AHI|1 night of modified ASV therapy with full polysomnography measurements
245974|NCT01405313|E2|Reported Event|Modified ASV|Intervention was modified ASV therapy
245975|NCT01405313|E1|Reported Event|Conventional ASV|Intervention was conventional ASV therapy
245976|NCT01405196|B5|Baseline|Total|Total of all reporting groups
245977|NCT01405196|B4|Baseline|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
245978|NCT01405196|B3|Baseline|PF-04236921 200 mg|Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
245979|NCT01405196|B2|Baseline|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
245980|NCT01405196|B1|Baseline|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
245981|NCT01405196|P4|Participant Flow|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
245982|NCT01405196|P3|Participant Flow|PF-04236921 200 mg|Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
245983|NCT01405196|P2|Participant Flow|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
245984|NCT01405196|P1|Participant Flow|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
245985|NCT01405196|O3|Outcome|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
245986|NCT01405196|O2|Outcome|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
245987|NCT01405196|O1|Outcome|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
245988|NCT01405196|O3|Outcome|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
245989|NCT01405196|O2|Outcome|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
245990|NCT01405196|O1|Outcome|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
245991|NCT01405196|O3|Outcome|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
245992|NCT01405196|O2|Outcome|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
245993|NCT01405196|O1|Outcome|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
245994|NCT01405196|O3|Outcome|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
245995|NCT01405196|O2|Outcome|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
245996|NCT01405196|O1|Outcome|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
245997|NCT01405196|O3|Outcome|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
245998|NCT01405196|O2|Outcome|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
245999|NCT01405196|O1|Outcome|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246000|NCT01405196|O3|Outcome|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246001|NCT01405196|O2|Outcome|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246002|NCT01405196|O1|Outcome|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246003|NCT01405196|O3|Outcome|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246004|NCT01405196|O2|Outcome|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246005|NCT01405196|O1|Outcome|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246006|NCT01405196|O3|Outcome|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246007|NCT01405196|O2|Outcome|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246008|NCT01405196|O1|Outcome|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246009|NCT01405196|O3|Outcome|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246010|NCT01405196|O2|Outcome|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246011|NCT01405196|O1|Outcome|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246012|NCT01405196|O3|Outcome|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246013|NCT01405196|O2|Outcome|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246014|NCT01405196|O1|Outcome|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246015|NCT01405196|O3|Outcome|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246016|NCT01405196|O2|Outcome|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246017|NCT01405196|O1|Outcome|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246018|NCT01405196|O3|Outcome|PF-04236921 200 mg|Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246019|NCT01405196|O2|Outcome|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246020|NCT01405196|O1|Outcome|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246021|NCT01405196|O4|Outcome|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246022|NCT01405196|O3|Outcome|PF-04236921 200 mg|Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246023|NCT01405196|O2|Outcome|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246024|NCT01405196|O1|Outcome|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246025|NCT01405196|O4|Outcome|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246026|NCT01405196|O3|Outcome|PF-04236921 200 mg|Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246027|NCT01405196|O2|Outcome|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246028|NCT01405196|O1|Outcome|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246029|NCT01405196|O4|Outcome|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246030|NCT01405196|O3|Outcome|PF-04236921 200 mg|Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246031|NCT01405196|O2|Outcome|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246032|NCT01405196|O1|Outcome|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246033|NCT01405196|O4|Outcome|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246034|NCT01405196|O3|Outcome|PF-04236921 200 mg|Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246035|NCT01405196|O2|Outcome|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246036|NCT01405196|O1|Outcome|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246037|NCT01405196|O4|Outcome|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246038|NCT01405196|O3|Outcome|PF-04236921 200 mg|Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246039|NCT01405196|O2|Outcome|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246040|NCT01405196|O1|Outcome|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246041|NCT01405196|O4|Outcome|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246042|NCT01405196|O3|Outcome|PF-04236921 200 mg|Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246043|NCT01405196|O2|Outcome|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246044|NCT01405196|O1|Outcome|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246045|NCT01405196|O4|Outcome|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246046|NCT01405196|O3|Outcome|PF-04236921 200 mg|Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246047|NCT01405196|O2|Outcome|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246048|NCT01405196|O1|Outcome|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246049|NCT01405196|O3|Outcome|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246050|NCT01405196|O2|Outcome|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246051|NCT01405196|O1|Outcome|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246052|NCT01405196|O3|Outcome|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246053|NCT01405196|O2|Outcome|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246054|NCT01405196|O1|Outcome|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246055|NCT01405196|O3|Outcome|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246056|NCT01405196|O2|Outcome|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246057|NCT01405196|O1|Outcome|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246058|NCT01405196|O3|Outcome|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246059|NCT01405196|O2|Outcome|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246060|NCT01405196|O1|Outcome|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246061|NCT01405196|O3|Outcome|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246062|NCT01405196|O2|Outcome|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246063|NCT01405196|O1|Outcome|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246064|NCT01405196|E4|Reported Event|Placebo|Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246065|NCT01405196|E3|Reported Event|PF-04236921 200 mg|Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246066|NCT01405196|E2|Reported Event|PF-04236921 50 mg|Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246067|NCT01405196|E1|Reported Event|PF-04236921 10 Milligram (10 mg)|Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
246068|NCT01405027|B3|Baseline|Total|Total of all reporting groups
246069|NCT01405027|B2|Baseline|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
246070|NCT01405027|B1|Baseline|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.~No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
246071|NCT01405027|P2|Participant Flow|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
246072|NCT01405027|P1|Participant Flow|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.~No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
246073|NCT01405027|O2|Outcome|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
246074|NCT01405027|O1|Outcome|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.~No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
246141|NCT01404611|O3|Outcome|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
246142|NCT01404611|O2|Outcome|DF277|"Ear drops~DF277: Ear drops"
246075|NCT01405027|O2|Outcome|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
246076|NCT01405027|O1|Outcome|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.~No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
246077|NCT01405027|O2|Outcome|Group B - Community Sites|"Group B - community physicians treating HCV but without clinical trial experience with an HCV protease inhibitor received patient education and management skills training from Hepatology Centers of Educational Expertise (HCEEs) during four (4) educational interventions.~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
246078|NCT01405027|O1|Outcome|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor. HCEE investigators provided patient education and management skills training during four (4) educational interventions to Community Site investigators.~Patient education and management skills training: Community sites received patient education and management skills training by HCEE investigators during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
246079|NCT01405027|O2|Outcome|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
246080|NCT01405027|O1|Outcome|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.~No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
246081|NCT01405027|O2|Outcome|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
246082|NCT01405027|O1|Outcome|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.~No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
246083|NCT01405027|E2|Reported Event|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
246084|NCT01405027|E1|Reported Event|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.~No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
246085|NCT01404988|B4|Baseline|Total|Total of all reporting groups
246086|NCT01404988|B3|Baseline|Attention Placebo Intervention (API)|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
246087|NCT01404988|B2|Baseline|Behavioral and Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education. Behavioral and Environmental Intervention will be delivered over the phone
246088|NCT01404988|B1|Baseline|Comprehensive Behavioral Intervention (BI)|Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.Behavioral Intervention will be delivered over the phone.
246089|NCT01404988|P3|Participant Flow|Attention Placebo Group (API) -|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
246090|NCT01404988|P2|Participant Flow|Behavioral & Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education. Behavioral and Environmental Intervention will be delivered over the phone
246091|NCT01404988|P1|Participant Flow|Comprehensive Behavioral Intervention (BI)|Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement over the phone.
246092|NCT01404988|O3|Outcome|Attention Placebo Group (API)|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
246093|NCT01404988|O2|Outcome|Behavioral & Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education. Behavioral and Environmental Intervention will be delivered over the phone
246094|NCT01404988|O1|Outcome|Comprehensive Behavioral Intervention (BI)|"Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.~Behavioral Intervention will be delivered over the phone."
246095|NCT01404988|O3|Outcome|Attention Placebo Group (API)|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
246096|NCT01404988|O2|Outcome|Behavioral & Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education. Behavioral and Environmental Intervention will be delivered over the phone
246097|NCT01404988|O1|Outcome|Comprehensive Behavioral Intervention (BI)|Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement. Behavioral Intervention will be delivered over the phone.
246098|NCT01404988|O3|Outcome|Attention Placebo Group (API)|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
246099|NCT01404988|O2|Outcome|Behavioral & Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education.Behavioral and Environmental Intervention will be delivered over the phone
246100|NCT01404988|O1|Outcome|Comprehensive Behavioral Intervention (BI)|Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement. Behavioral Intervention will be delivered over the phone.
246101|NCT01404988|O3|Outcome|Attention Placebo Group (API)|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
246102|NCT01404988|O2|Outcome|Behavioral & Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education.Behavioral and Environmental Intervention will be delivered over the phone
246103|NCT01404988|O1|Outcome|Comprehensive Behavioral Intervention (BI) -|"Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.~Behavioral Intervention will be delivered over the phone."
246104|NCT01404988|E3|Reported Event|Arm 3|"Attention Placebo Group (API) - patients will receive non-tailored counseling on general health topics.~Telephone-Delivered API: Attention Placebo Intervention will be delivered over the phone"
246143|NCT01404611|O1|Outcome|DF289|"Ear drops~DF289: Ear drops"
246144|NCT01404611|E3|Reported Event|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
246145|NCT01404611|E2|Reported Event|DF277|"Ear drops~DF277: Ear drops"
246146|NCT01404611|E1|Reported Event|DF289|"Ear drops~DF289: Ear drops"
246614|NCT01402427|E1|Reported Event|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
246105|NCT01404988|E2|Reported Event|Arm 2|"Behavioral & Environmental Intervention (BEI) - Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education.~Telephone-Delivered BEI: Behavioral and Environmental Intervention will be delivered over the phone"
246106|NCT01404988|E1|Reported Event|Arm 1|"Comprehensive behavioral intervention (BI) - Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.~Telephone-Delivered BI: Behavioral Intervention will be delivered over the phone."
246107|NCT01404936|B1|Baseline|Interferon-2A + Chemotherapy|Interferon-2A 4 (x106 IU/m^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)
246108|NCT01404936|P1|Participant Flow|Interferon-2A + Chemotherapy|Interferon-2A 4 (x106 IU/m^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)
246109|NCT01404936|O1|Outcome|Interferon-2A + Chemotherapy|Interferon-2A 4 (x106 IU/m^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)
246110|NCT01404936|E1|Reported Event|Interferon-2A + Chemotherapy|Interferon-2A 4 (x106 IU/m^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)
246111|NCT01404923|B3|Baseline|Total|Total of all reporting groups
246112|NCT01404923|B2|Baseline|Standard of Care|anti spasmodic agents: best standard of care prescriptions
246113|NCT01404923|B1|Baseline|Meteospasmyl|alverine citrate, simeticone: on-demand therapy
246114|NCT01404923|P2|Participant Flow|Standard of Care|anti spasmodic agents: best standard of care prescriptions
246115|NCT01404923|P1|Participant Flow|Meteospasmyl|alverine citrate, simeticone: on-demand therapy
246116|NCT01404923|O2|Outcome|Standard of Care|anti spasmodic agents: best standard of care prescriptions
246117|NCT01404923|O1|Outcome|Meteospasmyl|alverine citrate, simeticone: on-demand therapy
246118|NCT01404923|O2|Outcome|Standard of Care|anti spasmodic agents: best standard of care prescriptions
246119|NCT01404923|O1|Outcome|Meteospasmyl|alverine citrate, simeticone: on-demand therapy
246120|NCT01404923|E2|Reported Event|Standard of Care|anti spasmodic agents: best standard of care prescriptions
246121|NCT01404923|E1|Reported Event|Meteospasmyl|alverine citrate, simeticone: on-demand therapy
246122|NCT01404832|B1|Baseline|Patients Whose PPI Was Changed to Lansoprazole|In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
246123|NCT01404832|P1|Participant Flow|Patients Whose PPI Was Changed to Lansoprazole|In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
246124|NCT01404832|O1|Outcome|Patients Whose PPI Was Changed to Lansoprazole|In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
246125|NCT01404832|O1|Outcome|Patients Whose PPI Was Changed to Lansoprazole|In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
246126|NCT01404832|E1|Reported Event|Patients Whose PPI Was Changed to Lansoprazole|In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
246127|NCT01404650|B1|Baseline|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
246128|NCT01404650|P1|Participant Flow|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
246129|NCT01404650|O1|Outcome|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
246130|NCT01404650|O1|Outcome|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
246131|NCT01404650|O1|Outcome|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
246132|NCT01404650|O1|Outcome|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
246133|NCT01404650|E1|Reported Event|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
246134|NCT01404611|B4|Baseline|Total|Total of all reporting groups
246135|NCT01404611|B3|Baseline|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
246136|NCT01404611|B2|Baseline|DF277|"Ear drops~DF277: Ear drops"
246137|NCT01404611|B1|Baseline|DF289|"Ear drops~DF289: Ear drops"
246138|NCT01404611|P3|Participant Flow|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
246139|NCT01404611|P2|Participant Flow|DF277|"Ear drops~DF277: Ear drops"
246147|NCT01404572|B1|Baseline|All Treated|All participants tasted atazanavir, 15 mg/5 mL, in the current formulation and 2 new powder for oral use formulations in 3 different sequences
246148|NCT01404572|P3|Participant Flow|Treatment Sequence C, A, B|Participants in this sequence first tasted (Treatment C) atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose followed by at least a 45-minute washout period. Next, participants tasted (Treatment A) atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame. Following another at least 45-minute washout period, participants tasted (Treatment B) atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame.
246149|NCT01404572|P2|Participant Flow|Treatment Sequence B, C, A|Participants in this sequence first tasted (Treatment B) atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame. Following at least a 45-minute washout period, participants tasted (Treatment C) atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose. Following another 45-minute washout period, participants then tasted (Treatment A) atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame.
246150|NCT01404572|P1|Participant Flow|Treatment Sequence A, B, C|Participants in this sequence first tasted (Treatment A) atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame followed by at least a 45-minute washout period. Next, participants tasted (Treatment B) atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame. Following another at least 45-minute washout period, participants tasted (Treatment C) atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose.
246151|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
246152|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
246153|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
246154|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
246155|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
246156|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
246157|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
246158|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
246159|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
246160|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C).
246161|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
246162|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
246163|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame+ 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
246164|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
246165|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
246166|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
246167|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted received atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
246168|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
246169|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
246170|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
246171|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
246172|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
246173|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
246174|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
246175|NCT01404572|E3|Reported Event|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
246372|NCT01403090|E1|Reported Event|Angel Catheter|
246176|NCT01404572|E2|Reported Event|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
246177|NCT01404572|E1|Reported Event|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A)
246178|NCT01404559|B3|Baseline|Total|Total of all reporting groups
246179|NCT01404559|B2|Baseline|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
246180|NCT01404559|B1|Baseline|Transtibial Amputees|This arm included unilateral transtibial amputees who who were crossed over into 3 different prosthetic feet and assessed per intervention.
246181|NCT01404559|P4|Participant Flow|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
246182|NCT01404559|P3|Participant Flow|Prosthetic Foot 3 (Endolite Elite Blade)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3(Endolite Elite Blade; 1 week) the prosthetic foot 1(Ossur Variflex; 1 week) then prosthetic foot 2(Ossur Ceterus; 1 week).~Endolite Elite Blade prosthetic foot: Multi-axial prosthetic foot"
246183|NCT01404559|P2|Participant Flow|Prosthetic Foot 2 (Ossur Ceterus)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2(Ossur Ceterus; 1 week) then prosthetic foot 1 (Ossur Variflex; 1 week) then prosthetic foot 3(Endolite Elite Blade; 1 week).~Ossur Ceterus prosthetic foot: Shock-absorbing prosthetic foot"
246184|NCT01404559|P1|Participant Flow|Prosthetic Foot 1 (Ossur Variflex)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1 (Ossur Variflex; 1 week) then prosthetic foot 2(Ossur Ceterus; 1 week) then prosthetic foot 3(Endolite Elite Blade;1 week).~Ossur Variflex prosthetic foot: Lightweight energy-storing prosthetic foot"
246185|NCT01404559|O4|Outcome|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
246186|NCT01404559|O3|Outcome|Prosthetic Foot 3 (Endolite Elite Blade)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3.~Endolite Elite Blade prosthetic foot: Multi-axial prosthetic foot"
246187|NCT01404559|O2|Outcome|Prosthetic Foot 2 (Ossur Ceterus)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2.~Ossur Ceterus prosthetic foot: Shock-absorbing prosthetic foot"
246188|NCT01404559|O1|Outcome|Prosthetic Foot 1 (Ossur Variflex)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1.~Ossur Variflex prosthetic foot: Lightweight energy-storing prosthetic foot"
246189|NCT01404559|O4|Outcome|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
246190|NCT01404559|O3|Outcome|Prosthetic Foot 3 (Endolite Elite Blade)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3.~Endolite Elite Blade prosthetic foot: Multi-axial prosthetic foot"
246191|NCT01404559|O2|Outcome|Prosthetic Foot 2 (Ossur Ceterus)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2.~Ossur Ceterus prosthetic foot: Shock-absorbing prosthetic foot"
246192|NCT01404559|O1|Outcome|Prosthetic Foot 1 (Ossur Variflex)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1.~Ossur Variflex prosthetic foot: Lightweight energy-storing prosthetic foot"
246193|NCT01404559|E1|Reported Event|Unilateral Transtibial Amputees|This arm/group included unilateral transtibial amputees who who were assessed three times. They were exposed to 3 different prosthetic feet interventions.
246194|NCT01404429|B3|Baseline|Total|Total of all reporting groups
246195|NCT01404429|B2|Baseline|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
246196|NCT01404429|B1|Baseline|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
246197|NCT01404429|P2|Participant Flow|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
246198|NCT01404429|P1|Participant Flow|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
246199|NCT01404429|O2|Outcome|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
246200|NCT01404429|O1|Outcome|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
246201|NCT01404429|O2|Outcome|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
246202|NCT01404429|O1|Outcome|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
246203|NCT01404429|O2|Outcome|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
246204|NCT01404429|O1|Outcome|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
246205|NCT01404429|O2|Outcome|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
246206|NCT01404429|O1|Outcome|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
246207|NCT01404429|E2|Reported Event|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
246208|NCT01404429|E1|Reported Event|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
246209|NCT01404260|B3|Baseline|Total|Total of all reporting groups
246210|NCT01404260|B2|Baseline|Arm B|gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression
246211|NCT01404260|B1|Baseline|Arm A|"Arm A: gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, gefitinib 250mg/d every cycle d15-25, and gefitinib 250mg/d from d15 of last cycle until disease progression~gefitinib: gefitinib 250mg/d every cycle d15-25,and gefitinib 250mg/d from d15 of last cycle until disease progression"
246212|NCT01404260|P2|Participant Flow|Arm B: Gemcitabine + Carboplatin|Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression
246213|NCT01404260|P1|Participant Flow|Arm A: Gefitinib + Gemcitabine + Carboplatin|Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, Gefitinib 250mg/d every cycle d15-25, and Gefitinib 250mg/d from d15 of last cycle until disease progression
246214|NCT01404260|O2|Outcome|Arm B: Gemcitabine +Carboplatin|Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression
246215|NCT01404260|O1|Outcome|Arm A: Gefitinib+Gemcitabine +Carboplatin|Arm A: Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, Gefitinib 250mg/d every cycle d15-25, and Gefitinib 250mg/d from d15 of last cycle until disease progression
246216|NCT01404260|E2|Reported Event|Arm B|gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression
246217|NCT01404260|E1|Reported Event|Arm A|"Arm A: gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, gefitinib 250mg/d every cycle d15-25, and gefitinib 250mg/d from d15 of last cycle until disease progression~gefitinib: gefitinib 250mg/d every cycle d15-25,and gefitinib 250mg/d from d15 of last cycle until disease progression"
246218|NCT01404234|B1|Baseline|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
246219|NCT01404234|P1|Participant Flow|AZLI|Participants received three 28-day courses of Aztreonam for Inhalation Solution (AZLI), each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
246220|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
246221|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
246222|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
246223|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
246224|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
246225|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
246226|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
246227|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
246228|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
246229|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
246230|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
246231|NCT01404234|E1|Reported Event|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
246232|NCT01404208|B3|Baseline|Total|Total of all reporting groups
246233|NCT01404208|B2|Baseline|Sugar Pill|Placebo: Sugar pill
246234|NCT01404208|B1|Baseline|D-Cycloserine|D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
246235|NCT01404208|P2|Participant Flow|Sugar Pill|Placebo: Sugar pill
246236|NCT01404208|P1|Participant Flow|D-Cycloserine|D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
246237|NCT01404208|O2|Outcome|Sugar Pill|Placebo: Sugar pill
246238|NCT01404208|O1|Outcome|D-Cycloserine|D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
246239|NCT01404208|O2|Outcome|Sugar Pill|Placebo: Sugar pill
246240|NCT01404208|O1|Outcome|D-Cycloserine|D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
246241|NCT01404208|E2|Reported Event|Sugar Pill|Placebo: Sugar pill
246373|NCT01403051|B3|Baseline|Total|Total of all reporting groups
246242|NCT01404208|E1|Reported Event|D-Cycloserine|D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
246243|NCT01404078|B3|Baseline|Total|Total of all reporting groups
246244|NCT01404078|B2|Baseline|Polycap Double Dose Plus Potassium|"Patients in this arm received one dose of low strength Polycap with potassium~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
246245|NCT01404078|B1|Baseline|Polycap Single Dose|Patients in this arm received single dose of low strength Polycap only Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin
246246|NCT01404078|P2|Participant Flow|Two Doses of Low Strength Polycap|"Patients in this arm will receive 2 doses of low strength Polycap.~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
246247|NCT01404078|P1|Participant Flow|One Dose of Low Srength Polycap|"Patients in this arm will receive one dose of low strength Polycap~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
246248|NCT01404078|O2|Outcome|One Dose of Low Srength Polycap|"Patients in this arm will receive one dose of low strength Polycap~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
246249|NCT01404078|O1|Outcome|Two Doses of Low Strength Polycap|"Patients in this arm will receive 2 doses of low strength Polycap.~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
246250|NCT01404078|E2|Reported Event|One Dose of Low Srength Polycap|"Patients in this arm will receive one dose of low strength Polycap~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
246251|NCT01404078|E1|Reported Event|Two Doses of Low Strength Polycap|"Patients in this arm will receive 2 doses of low strength Polycap.~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
246252|NCT01404039|B10|Baseline|Total|Total of all reporting groups
246253|NCT01404039|B9|Baseline|Mental Imagery (MI) - Control|
246254|NCT01404039|B8|Baseline|Mental Imagery (MI) - Real|
246255|NCT01404039|B7|Baseline|Observational Task (OT) - Control|
246256|NCT01404039|B6|Baseline|Observational Task (OT) - Real|
246257|NCT01404039|B5|Baseline|Somatosensory Learning (SL) Control Group|
246258|NCT01404039|B4|Baseline|Somatosensory Activation (S Activation)|
246259|NCT01404039|B3|Baseline|Somatosensory Learning (SL Blind)|
246260|NCT01404039|B2|Baseline|Somatosensory Learning (SL Sighted)|
246261|NCT01404039|B1|Baseline|Motor Learning (ML)|This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.
246262|NCT01404039|P13|Participant Flow|tDCS - Sham|This experimental arm will be conducted in a cross-over design (active tDCS and sham tDCS).
246263|NCT01404039|P12|Participant Flow|tDCS - Active|This experimental arm will be conducted in a cross-over design (active tDCS and sham tDCS).
246264|NCT01404039|P11|Participant Flow|Mental Imagery (MI) - Control Group|Control Group - Mental Imagery: Subjects will be asked to perform simple mental math calculations for 20 minutes. (ex. adding or subtracting a one digit number from a starting number (1+1=2; 2+1=3; 3+1= 4 and so on.)
246265|NCT01404039|P10|Participant Flow|Mental Imagery (MI)|Mental Imagery: Subjects will be seated in a chair and are asked to keep their arm and hand muscles fully relaxed. Then they will be asked to imagine repetitive movement of the left index finger to the left thumb for 5 minutes. Subjects then will be asked to imagine sequential movement of left finger to left thumb (thumb to 2nd, 3rd, 4th, 5th) for 5 minutes.
246266|NCT01404039|P9|Participant Flow|Observational Task (OT) - Control Group|Control Group -- Observational Task: Subjects in this group will be asked to watch a video of random geometric forms for the same duration of time as those in the observational task group.
246267|NCT01404039|P8|Participant Flow|Observational Task (OT)|Observational Task: Subjects in this group will watch a 10 second video of a right-handed person performing movements of their left index finger at a 1 Hz rate on a screen at a distance of 1 meter away. Subjects will be instructed to watch the video without any other specific instruction.
246268|NCT01404039|P7|Participant Flow|Somatosensory Learning (SL) Control Group|"In this arm,the subjects will not receive any somatosensory input (SL control group).~There will be an anticipated total of 10 subjects in this experimental arm. This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control)."
246269|NCT01404039|P6|Participant Flow|Somatosensory Activation (S Activation)|"In this arm, subject will receive simple sensory stimulation over their left index finger - Sactivation.~There will be an anticipated total of 10 subjects in this experimental arm.This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control)."
246270|NCT01404039|P5|Participant Flow|Somatosensory Learning (SL Blind)|"In this arm, subject will perform sensory Learning without visual feedback - SL blind.~There will be an anticipated total of 10 subjects in this experimental arm. This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control)."
246271|NCT01404039|P4|Participant Flow|Somatosensory Learning (SL Sighted)|"In this arm, subject will perform sensory Learning with visual feedback - SL sighted.~There will be an anticipated total of 10 subjects in this experimental arm. This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control)."
246272|NCT01404039|P3|Participant Flow|Motor Learning (ML) MLcontrol Group/MLsighted/MLblind|This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.
246414|NCT01402986|P3|Participant Flow|Placebo, Q2/4W - Cohort 2|Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246273|NCT01404039|P2|Participant Flow|Motor Learning (ML) MLblind/MLcontrol/MLsighted|This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.
246274|NCT01404039|P1|Participant Flow|Motor Learning - MLsighted/MLblind/MLcontrol|This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.
246275|NCT01404039|O11|Outcome|Mental Imagery (MI) - MI Control|
246276|NCT01404039|O10|Outcome|Mental Imagery (MI) - MI Real|
246277|NCT01404039|O9|Outcome|Observational Task (OT)- OT Control|
246278|NCT01404039|O8|Outcome|Observational Task (OT)- OT Real|
246279|NCT01404039|O7|Outcome|Somatosensory Learning (SL)-SL Control|
246280|NCT01404039|O6|Outcome|Somatosensory Learning (SL)-SL Activation|
246281|NCT01404039|O5|Outcome|Somatosensory Learning (SL)-SL Blind|
246282|NCT01404039|O4|Outcome|Somatosensory Learning (SL)- SL Sighted|
246283|NCT01404039|O3|Outcome|Motor Learning - ML Control|
246284|NCT01404039|O2|Outcome|Motor Learning -ML Blind|
246285|NCT01404039|O1|Outcome|Motor Learning (ML)-Sighted|
246286|NCT01404039|E11|Reported Event|Mental Imagery (MI) - Control|
246287|NCT01404039|E10|Reported Event|Mental Imagery (MI) - Real|
246288|NCT01404039|E9|Reported Event|Observational Task (OT) - Control|
246289|NCT01404039|E8|Reported Event|Observational Task (OT) - Real|
246290|NCT01404039|E7|Reported Event|Somatosensory Learning (SL) Control|
246291|NCT01404039|E6|Reported Event|Somatosensory Activation (SA)|
246292|NCT01404039|E5|Reported Event|Somatosensory Learning (SL) Blind|
246293|NCT01404039|E4|Reported Event|Somatosensory Learning (SL) Sighted|
246294|NCT01404039|E3|Reported Event|Motor Learning (ML) Control|
246295|NCT01404039|E2|Reported Event|Motor Learning (ML) Blind|
246296|NCT01404039|E1|Reported Event|Motor Learning (ML) Sighted|
246297|NCT01403987|B4|Baseline|Total|Total of all reporting groups
246298|NCT01403987|B3|Baseline|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
246299|NCT01403987|B2|Baseline|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
246300|NCT01403987|B1|Baseline|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
246301|NCT01403987|P3|Participant Flow|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
246302|NCT01403987|P2|Participant Flow|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
246303|NCT01403987|P1|Participant Flow|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
246304|NCT01403987|O3|Outcome|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
246305|NCT01403987|O2|Outcome|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
246306|NCT01403987|O1|Outcome|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
246307|NCT01403987|O3|Outcome|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
246308|NCT01403987|O2|Outcome|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
246309|NCT01403987|O1|Outcome|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
246310|NCT01403987|O3|Outcome|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
246311|NCT01403987|O2|Outcome|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
246312|NCT01403987|O1|Outcome|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
246416|NCT01402986|P1|Participant Flow|Placebo, Q2W - Cohort 1|Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246313|NCT01403987|E3|Reported Event|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
246314|NCT01403987|E2|Reported Event|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
246315|NCT01403987|E1|Reported Event|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
246316|NCT01403805|B3|Baseline|Total|Total of all reporting groups
246317|NCT01403805|B2|Baseline|Oral Care With Influenza and Pneumococcal Vaccines|"Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;~1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material."
246318|NCT01403805|B1|Baseline|Influenza Vaccine|Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).
246319|NCT01403805|P2|Participant Flow|Oral Care With Influenza and Pneumococcal Vaccines|"Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;~1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material."
246320|NCT01403805|P1|Participant Flow|Influenza Vaccine|Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).
246321|NCT01403805|O1|Outcome|Died Before Oral Care Starting|Number of resident died before the start of oral care
246322|NCT01403805|O1|Outcome|Reject Vaccine|Number of resident to reject vaccine
246323|NCT01403805|O1|Outcome|Reject Oral Care|Number of resident to reject oral care
246324|NCT01403805|O1|Outcome|Leaving Nursing Home|Numer of resident for leaving nursing home
246325|NCT01403805|O2|Outcome|Oral Care With Influenza and Pneumococcal Vaccines|"Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;~1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material."
246326|NCT01403805|O1|Outcome|Influenza Vaccine|Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).
246327|NCT01403805|O2|Outcome|Oral Care With Influenza and Pneumococcal Vaccines|"Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;~1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material."
246328|NCT01403805|O1|Outcome|Influenza Vaccine|Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).
246329|NCT01403805|E2|Reported Event|Oral Care With Influenza and Pneumococcal Vaccines|"Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;~1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material."
246330|NCT01403805|E1|Reported Event|Influenza Vaccine|Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).
246331|NCT01403441|B1|Baseline|Open Treatment Study|Open treatment with Cyberknife System targeting brain area cingulate 25.
246332|NCT01403441|P1|Participant Flow|Open Treatment Study|All three subjects had Cyberknife treatment targeting the subgenual cingulate cortex, and then followed for 12 months observation and assessments of depression severity.
246615|NCT01402375|B7|Baseline|Total|Total of all reporting groups
246333|NCT01403441|O1|Outcome|Open Treatment Study|Subjects had precision targeted radiotherapy using the Cyberknife System that targeted the subgenual cingulate cortex (approximating Brodmann area 25), and then had assessments of depression severity at intervals for 12 months.
246334|NCT01403441|O1|Outcome|Open Treatment Study|Subjects had precision targeted radiotherapy using the Cyberknife System that targeted the subgenual cingulate cortex (approximating Brodmann area 25), and then had assessments of depression severity at intervals for 12 months.
246335|NCT01403441|O1|Outcome|Open Treatment Study|All three subjects had Cyberknife treatment, and then followed for 12 months observation and assessments.
246336|NCT01403441|O1|Outcome|Radiosurgical Neuromodulation|"Bilateral Radiosurgical Neuromodulation using the Cyberknife~Radiosurgical Neuromodulation using the Cyberknife: our team has selected 60 Gy as the dose to the target margin to be used for radiosurgical neuromodulation in patients with intractable bipolar disorder; the target being the anterior cingulate that correlates with Brodmann area 25 (Cg25)."
246337|NCT01403441|E1|Reported Event|Radiosurgical Neuromodulation|"Precision stereotactic radiotherapy targeted the subgenual cingulate cortex (which approximates Brodmann area cingulate 25) using 60 Gy as the dose to the target margin using the CyberKnife System.~Subject 3 had a signal abnormality on the MRI of the brain at 9 month time point which was unchanged 12 months on both T1 and T2 acquisition images. This is one adverse event that was sustained. The presence of the signal abnormality at 9 and 12 months indicates it did not change. A change in this type of signal abnormality would not be expected to resolve on that time scale. This adverse event is one occurrence that sustained for the next 3 months."
246338|NCT01403376|B4|Baseline|Total|Total of all reporting groups
246339|NCT01403376|B3|Baseline|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
246340|NCT01403376|B2|Baseline|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
246341|NCT01403376|B1|Baseline|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
246342|NCT01403376|P3|Participant Flow|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
246343|NCT01403376|P2|Participant Flow|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
246344|NCT01403376|P1|Participant Flow|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
246345|NCT01403376|O3|Outcome|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
246346|NCT01403376|O2|Outcome|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
246347|NCT01403376|O1|Outcome|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
246348|NCT01403376|O3|Outcome|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
246349|NCT01403376|O2|Outcome|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
246350|NCT01403376|O1|Outcome|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
246351|NCT01403376|O3|Outcome|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
246352|NCT01403376|O2|Outcome|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
246353|NCT01403376|O1|Outcome|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
246354|NCT01403376|O3|Outcome|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
246355|NCT01403376|O2|Outcome|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
246356|NCT01403376|O1|Outcome|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
246357|NCT01403376|O3|Outcome|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
246358|NCT01403376|O2|Outcome|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
246359|NCT01403376|O1|Outcome|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
246360|NCT01403376|E3|Reported Event|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
246361|NCT01403376|E2|Reported Event|Teriflunomide 14mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
246362|NCT01403376|E1|Reported Event|Teriflunomide 7mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
246363|NCT01403194|B1|Baseline|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
246364|NCT01403194|P1|Participant Flow|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
246365|NCT01403194|O1|Outcome|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
246366|NCT01403194|O1|Outcome|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
246367|NCT01403194|O1|Outcome|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
246368|NCT01403194|E1|Reported Event|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
246369|NCT01403090|B1|Baseline|Angel Catheter|Angel Catheter Placement : The Angel Catheter will be inserted in the femoral vein following standard central line placement techniques. Once the catheter is on the Inferior Vena Cava, the filter will be deployed following the manufacturer instructions and secured to the skin.
246370|NCT01403090|P1|Participant Flow|Angel Catheter|Angel Catheter Placement : The Angel Catheter will be inserted in the femoral vein following standard central line placement techniques. Once the catheter is on the Inferior Vena Cava, the filter will be deployed following the manufacturer instructions and secured to the skin.
246371|NCT01403090|O1|Outcome|Angel Catheter|Angel Catheter Placement : The Angel Catheter will be inserted in the femoral vein following standard central line placement techniques. Once the catheter is on the Inferior Vena Cava, the filter will be deployed following the manufacturer instructions and secured to the skin.
246374|NCT01403051|B2|Baseline|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246375|NCT01403051|B1|Baseline|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246376|NCT01403051|P2|Participant Flow|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246377|NCT01403051|P1|Participant Flow|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246378|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246379|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246380|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246381|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246382|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246383|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246384|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246385|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246608|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
246719|NCT01402128|E2|Reported Event|Placebo|Placebo for 12 weeks
246386|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246387|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246388|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246389|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246390|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246391|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246392|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246393|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246394|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246395|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246396|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246397|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246415|NCT01402986|P2|Participant Flow|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246398|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246399|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246400|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246401|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246402|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246403|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246404|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246405|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246406|NCT01403051|E2|Reported Event|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246407|NCT01403051|E1|Reported Event|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
246408|NCT01402986|B5|Baseline|Total|Total of all reporting groups
246409|NCT01402986|B4|Baseline|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246410|NCT01402986|B3|Baseline|Placebo, Q2/4W - Cohort 2|Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246411|NCT01402986|B2|Baseline|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246412|NCT01402986|B1|Baseline|Placebo, Q2W - Cohort 1|Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246413|NCT01402986|P4|Participant Flow|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246609|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
246417|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246418|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246419|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246420|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246421|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246422|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246423|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246424|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246425|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246426|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246427|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246428|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246429|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246430|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246431|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246432|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246433|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246434|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246435|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246436|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246437|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246438|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246439|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246440|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246441|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246442|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246443|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246444|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246445|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246446|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246447|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246448|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246449|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246450|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246451|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246452|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246453|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246454|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246455|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246456|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246457|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246458|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246459|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246460|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246461|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246462|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246463|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246464|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246465|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246466|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246467|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246468|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246469|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246470|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246471|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246472|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246473|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246474|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246475|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246476|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246477|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246478|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246479|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246480|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246481|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246482|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246483|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246484|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246485|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246486|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246487|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246488|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246489|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246490|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246491|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246492|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246493|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246494|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246495|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246496|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246497|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246498|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246499|NCT01402986|O1|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246500|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246501|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246502|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246503|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246504|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246505|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246506|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246507|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246508|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246509|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246510|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246511|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246512|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246513|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246514|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246515|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246516|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246517|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246518|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246519|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246520|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246521|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246522|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246523|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246524|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246610|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
246525|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246526|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246527|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246528|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246529|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246530|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246531|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246532|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246533|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246534|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246535|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246536|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246537|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246538|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246539|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246540|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246541|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246542|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246543|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246544|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246545|NCT01402986|E3|Reported Event|Tralokinumab 300 mg Q2/4W|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246546|NCT01402986|E2|Reported Event|Tralokinumab 300 mg Q2W|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
246547|NCT01402986|E1|Reported Event|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
246548|NCT01402947|B3|Baseline|Total|Total of all reporting groups
246549|NCT01402947|B2|Baseline|MMX Mesalazine/Mesalamine + Ciprofloxacin First|MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for first intervention; then MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for second intervention
246550|NCT01402947|B1|Baseline|MMX Placebo + Ciprofloxacin First|MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for first intervention; then MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for second intervention
265239|NCT01344460|O1|Outcome|Gadobutrol-Enhanced MRA|
246551|NCT01402947|P2|Participant Flow|MMX Mesalazine/Mesalamine + Ciprofloxacin First|MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for first intervention; then MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for second intervention
246552|NCT01402947|P1|Participant Flow|MMX Placebo + Ciprofloxacin First|MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for first intervention; then MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for second intervention
246553|NCT01402947|O2|Outcome|MMX Mesalazine/Mesalamine + Ciprofloxacin|MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4
246554|NCT01402947|O1|Outcome|MMX Placebo + Ciprofloxacin|MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4
246555|NCT01402947|O2|Outcome|MMX Mesalazine/Mesalamine + Ciprofloxacin|MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4
246556|NCT01402947|O1|Outcome|MMX Placebo + Ciprofloxacin|MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4
246557|NCT01402947|E2|Reported Event|MMX Mesalazine/Mesalamine + Ciprofloxacin|MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4
246558|NCT01402947|E1|Reported Event|MMX Placebo + Ciprofloxacin|MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4
246559|NCT01402869|B4|Baseline|Total|Total of all reporting groups
246560|NCT01402869|B3|Baseline|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
246561|NCT01402869|B2|Baseline|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
246562|NCT01402869|B1|Baseline|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
246563|NCT01402869|P3|Participant Flow|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
246564|NCT01402869|P2|Participant Flow|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
246565|NCT01402869|P1|Participant Flow|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
246566|NCT01402869|O3|Outcome|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
246567|NCT01402869|O2|Outcome|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
246568|NCT01402869|O1|Outcome|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
246569|NCT01402869|O3|Outcome|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
246570|NCT01402869|O2|Outcome|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
246571|NCT01402869|O1|Outcome|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
246572|NCT01402869|O3|Outcome|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
246573|NCT01402869|O2|Outcome|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
246574|NCT01402869|O1|Outcome|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
246575|NCT01402869|E3|Reported Event|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
246576|NCT01402869|E2|Reported Event|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
246577|NCT01402869|E1|Reported Event|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
246578|NCT01402817|B1|Baseline|Sutent®/Sunitinib|Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Again, subjects will take that dose for 28 days followed by a rest period of 14 days. Adults who tolerate the increase will go up to the maximum dose of 50mg.The maximum dose for children is 15mg/m2/day.
246611|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
246612|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
246613|NCT01402427|E2|Reported Event|Placebo|Placebo: Intraarterial administration of 10 mL saline.
246720|NCT01402128|E1|Reported Event|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
246579|NCT01402817|P1|Participant Flow|Sutent®/Sunitinib|Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Again, subjects will take that dose for 28 days followed by a rest period of 14 days. Adults who tolerate the increase will go up to the maximum dose of 50mg.The maximum dose for children is 15mg/m2/day.
246580|NCT01402817|O1|Outcome|Sutent®/Sunitinib|Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Again, subjects will take that dose for 28 days followed by a rest period of 14 days. Adults who tolerate the increase will go up to the maximum dose of 50mg.The maximum dose for children is 15mg/m2/day.
246581|NCT01402817|O1|Outcome|Sutent®/Sunitinib|Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Adults who tolerate the increase will go up to the maximum dose of 50mg. The maximum dose for children is 15mg/m2/day.
246582|NCT01402817|E1|Reported Event|Sutent®/Sunitinib|Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Again, subjects will take that dose for 28 days followed by a rest period of 14 days. Adults who tolerate the increase will go up to the maximum dose of 50mg.The maximum dose for children is 15mg/m2/day.
246583|NCT01402700|B1|Baseline|Visi-Pro™ Balloon Expandable Stent System|"The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery."
246584|NCT01402700|P1|Participant Flow|Visi-Pro™ Balloon Expandable Stent System|"The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery."
246585|NCT01402700|O1|Outcome|Visi-Pro™ Balloon Expandable Stent System|"The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery."
246586|NCT01402700|E1|Reported Event|Visi-Pro™ Balloon Expandable Stent System|"The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery."
246587|NCT01402570|B1|Baseline|Study Group|All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
246588|NCT01402570|P1|Participant Flow|Study Group|All subjects took a three month trials of 1,000 mg of glutathione supplement
246589|NCT01402570|O1|Outcome|Study Group|All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
246590|NCT01402570|O1|Outcome|Study Group|All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
246591|NCT01402570|O1|Outcome|Study Group|All subjects took a three month trials of 1,000 mg of glutathione supplement
246592|NCT01402570|O1|Outcome|Study Group|All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
246593|NCT01402570|E1|Reported Event|Study Group|All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
246594|NCT01402427|B3|Baseline|Total|Total of all reporting groups
246595|NCT01402427|B2|Baseline|Placebo|Placebo: Intraarterial administration of 10 mL saline.
246596|NCT01402427|B1|Baseline|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
246597|NCT01402427|P2|Participant Flow|Placebo|Placebo: Intraarterial administration of 10 mL saline.
246598|NCT01402427|P1|Participant Flow|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
246599|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
246600|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
246601|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
246602|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
246603|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
246604|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
246605|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
246606|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
246607|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
246721|NCT01402115|B3|Baseline|Total|Total of all reporting groups
246616|NCT01402375|B6|Baseline|Hydrocodone (Third Trial)|"Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.~Hydrocodone (third trial): Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain."
246617|NCT01402375|B5|Baseline|Oxycodone (Third Trial)|"Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.~Oxycodone (third trial): Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain"
246618|NCT01402375|B4|Baseline|Codeine (for Second Trial)|"Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Codeine (for second trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain"
246619|NCT01402375|B3|Baseline|Oxycodone (for Second Trial)|"Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Oxycodone (for second trial): Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain"
246620|NCT01402375|B2|Baseline|Codeine (First Trial)|"Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Codeine (first trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain"
246621|NCT01402375|B1|Baseline|Hydrocodone (First Trial)|"Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Hydrocodone (first trial): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain"
246622|NCT01402375|P6|Participant Flow|Hydrocodone (Third Trial)|"Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.~Hydrocodone (third trial): Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain."
246623|NCT01402375|P5|Participant Flow|Oxycodone (Third Trial)|"Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.~Oxycodone (third trial): Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain"
246624|NCT01402375|P4|Participant Flow|Codeine (for Second Trial)|"Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Codeine (for second trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain"
246625|NCT01402375|P3|Participant Flow|Oxycodone (for Second Trial)|"Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Oxycodone (for second trial): Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain"
246626|NCT01402375|P2|Participant Flow|Codeine (First Trial)|"Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Codeine (first trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain"
246627|NCT01402375|P1|Participant Flow|Hydrocodone (First Trial)|"Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Hydrocodone (first trial): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain"
246628|NCT01402375|O6|Outcome|Hydrocodone (Third Trial)|"Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.~Hydrocodone (third trial): Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain."
246629|NCT01402375|O5|Outcome|Oxycodone (Third Trial)|"Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.~Oxycodone (third trial): Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain"
246630|NCT01402375|O4|Outcome|Codeine (for Second Trial)|"Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Codeine (for second trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain"
246631|NCT01402375|O3|Outcome|Oxycodone (for Second Trial)|"Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Oxycodone (for second trial): Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain"
246632|NCT01402375|O2|Outcome|Codeine (First Trial)|"Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Codeine (first trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain"
246633|NCT01402375|O1|Outcome|Hydrocodone (First Trial)|"Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Hydrocodone (first trial): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain"
246634|NCT01402375|O6|Outcome|Hydrocodone (Third Trial)|"Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.~Hydrocodone (third trial): Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain."
246635|NCT01402375|O5|Outcome|Oxycodone (Third Trial)|"Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.~Oxycodone (third trial): Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain"
246636|NCT01402375|O4|Outcome|Codeine (for Second Trial)|"Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Codeine (for second trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain"
246637|NCT01402375|O3|Outcome|Oxycodone (for Second Trial)|"Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Oxycodone (for second trial): Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain"
246638|NCT01402375|O2|Outcome|Codeine (First Trial)|"Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Codeine (first trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain"
246639|NCT01402375|O1|Outcome|Hydrocodone (First Trial)|"Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Hydrocodone (first trial): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain"
246640|NCT01402375|O6|Outcome|Hydrocodone (Third Trial)|"Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.~Hydrocodone (third trial): Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain."
246641|NCT01402375|O5|Outcome|Oxycodone (Third Trial)|"Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.~Oxycodone (third trial): Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain"
246642|NCT01402375|O4|Outcome|Codeine (for Second Trial)|"Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Codeine (for second trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain"
246643|NCT01402375|O3|Outcome|Oxycodone (for Second Trial)|"Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Oxycodone (for second trial): Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain"
246644|NCT01402375|O2|Outcome|Codeine (First Trial)|"Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Codeine (first trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain"
246645|NCT01402375|O1|Outcome|Hydrocodone (First Trial)|"Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Hydrocodone (first trial): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain"
246646|NCT01402375|O6|Outcome|Hydrocodone (Third Trial)|"Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.~Hydrocodone (third trial): Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain."
246647|NCT01402375|O5|Outcome|Oxycodone (Third Trial)|"Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.~Oxycodone (third trial): Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain"
246648|NCT01402375|O4|Outcome|Codeine (for Second Trial)|"Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Codeine (for second trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain"
246649|NCT01402375|O3|Outcome|Oxycodone (for Second Trial)|"Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Oxycodone (for second trial): Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain"
246650|NCT01402375|O2|Outcome|Codeine (First Trial)|"Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Codeine (first trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain"
246651|NCT01402375|O1|Outcome|Hydrocodone (First Trial)|"Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Hydrocodone (first trial): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain"
246652|NCT01402375|E6|Reported Event|Hydrocodone (Third Trial)|"Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.~Hydrocodone (third trial): Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain."
246653|NCT01402375|E5|Reported Event|Oxycodone (Third Trial)|"Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.~Oxycodone (third trial): Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain"
246654|NCT01402375|E4|Reported Event|Codeine (for Second Trial)|"Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Codeine (for second trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain"
246655|NCT01402375|E3|Reported Event|Oxycodone (for Second Trial)|"Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Oxycodone (for second trial): Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain"
246656|NCT01402375|E2|Reported Event|Codeine (First Trial)|"Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Codeine (first trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain"
246657|NCT01402375|E1|Reported Event|Hydrocodone (First Trial)|"Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.~Hydrocodone (first trial): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain"
246658|NCT01402284|B1|Baseline|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
246659|NCT01402284|P1|Participant Flow|Carfilzomib, Lenalidomide, and Dexamethasone Therapy|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
246722|NCT01402115|B2|Baseline|Placebo|Placebo 15mg for 12 weeks
246723|NCT01402115|B1|Baseline|Polycan|Polycan 150mg for 12 weeks
246724|NCT01402115|P2|Participant Flow|Placebo|Placebo 15mg for 12 weeks
246725|NCT01402115|P1|Participant Flow|Polycan|Polycan 150mg for 12 weeks
246660|NCT01402284|O1|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
246661|NCT01402284|O1|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
246662|NCT01402284|O1|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
246663|NCT01402284|O1|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
246664|NCT01402284|O1|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
246665|NCT01402284|O1|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
246666|NCT01402284|O1|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
246726|NCT01402115|O2|Outcome|Placebo|Placebo 15mg for 12 weeks
246727|NCT01402115|O1|Outcome|Polycan|Polycan 150mg for 12 weeks
246728|NCT01402115|O2|Outcome|Placebo|Placebo 15mg for 12 weeks
246729|NCT01402115|O1|Outcome|Polycan|Polycan 150mg for 12 weeks
246730|NCT01402115|O2|Outcome|Placebo|Placebo 15mg for 12 weeks
246667|NCT01402284|O1|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
246668|NCT01402284|E1|Reported Event|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
246669|NCT01402141|B3|Baseline|Total|Total of all reporting groups
246670|NCT01402141|B2|Baseline|Placebo(35g)|
246671|NCT01402141|B1|Baseline|Chungkookjang(35g)|
246672|NCT01402141|P2|Participant Flow|Placebo|"Placebo(3times/day, 3packs/day, 35g/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Chungkookjang."
246673|NCT01402141|P1|Participant Flow|Chungkookjang|"Chungkookjang(3times/day, 3packs/day, 35g/day) for 12weeks~Chungkookjang: The Chungkookjang was manufactured from raw beans, peels made after freeze-drying"
246674|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
246675|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
246676|NCT01402141|O2|Outcome|Placeb|Oral intake placebo(35g/day) for 12weeks
246677|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
246678|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
246679|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
246680|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
246681|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
246682|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
246683|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
246684|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
246685|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
246686|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
246687|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
246688|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
246689|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
246690|NCT01402141|E2|Reported Event|Placebo(35g)|Oral intake placebo(35g/day) for 12weeks
246691|NCT01402141|E1|Reported Event|Chungkookjang(35g)|Oral intake Chungkookjang(35g) for 12weeks.
246692|NCT01402128|B3|Baseline|Total|Total of all reporting groups
246693|NCT01402128|B2|Baseline|Placebo|Placebo for 12 weeks
246694|NCT01402128|B1|Baseline|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
246695|NCT01402128|P2|Participant Flow|Placebo|"Placebo(1times/day, 1packs/day, 3g/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Barley beta-glucan"
246696|NCT01402128|P1|Participant Flow|Barley Beta-glucan|"Barley beta-glucan(1times/day, 1packs/day, 3g/day) for 12weeks~Barley beta-glucan: Barley as raw material is milled by crushing the liquefaction and saccharification enzymes reacted after baking yeast (S. cereviasiae) for 48 h, is produced through the fermentation process."
246697|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
246698|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
246699|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
246700|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
246701|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
246702|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
246703|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
246704|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
246705|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
246706|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
246707|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
246708|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
246709|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
246710|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
246711|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
246712|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
246713|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
246714|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
246715|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
246716|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
246717|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
246718|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
246740|NCT01402102|B1|Baseline|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
246741|NCT01402102|P2|Participant Flow|Placebo|Oral intake placebo(6.0g/day) for 12weeks
246742|NCT01402102|P1|Participant Flow|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
246743|NCT01402102|O2|Outcome|Placebo|Oral intake placebo(6.0g/day) for 12weeks
246744|NCT01402102|O1|Outcome|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
246745|NCT01402102|O2|Outcome|Placebo|Oral intake placebo(6.0g/day) for 12weeks
246746|NCT01402102|O1|Outcome|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
246747|NCT01402102|O2|Outcome|Placebo|Oral intake placebo(6.0g/day) for 12weeks
246748|NCT01402102|O1|Outcome|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
246749|NCT01402102|O2|Outcome|Placebo|Oral intake placebo(6.0g/day) for 12weeks
246750|NCT01402102|O1|Outcome|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
246751|NCT01402102|O2|Outcome|Placebo|Placebo 6.0g/day oral intake
246752|NCT01402102|O1|Outcome|Aged Garlic Powder|Aged garlic powder 6.0g/day oral intake
246753|NCT01402102|O2|Outcome|Placebo|Placebo 6.0g/day oral intake
246754|NCT01402102|O1|Outcome|Aged Garlic Powder|Aged garlic powder 6.0g/day oral intake
246755|NCT01402102|O2|Outcome|Placebo|Oral intake placebo(6.0g/day) for 12weeks
246756|NCT01402102|O1|Outcome|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
246757|NCT01402102|E2|Reported Event|Placebo|Oral intake placebo(6.0g/day) for 12weeks
246758|NCT01402102|E1|Reported Event|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
246759|NCT01402063|B3|Baseline|Total|Total of all reporting groups
246760|NCT01402063|B2|Baseline|Radiation + Temozolomide|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days~Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum"
246761|NCT01402063|B1|Baseline|Radiation Plus PPX(CT2103|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ intravenous PPX every week x 6 weeks for a total of 6 treatments~PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum."
246762|NCT01402063|P2|Participant Flow|Radiation + Temozolomide|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days~Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum"
246763|NCT01402063|P1|Participant Flow|Radiation Plus PPX(CT2103|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ intravenous PPX every week x 6 weeks for a total of 6 treatments~PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum."
246764|NCT01402063|O2|Outcome|Radiation + Temozolomide|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days~Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum"
246765|NCT01402063|O1|Outcome|Radiation Plus PPX(CT2103|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ intravenous PPX every week x 6 weeks for a total of 6 treatments~PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum."
246766|NCT01402063|E2|Reported Event|Radiation + Temozolomide and Maintenance|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days~Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum"
246767|NCT01402063|E1|Reported Event|Radiation Plus PPX and Maintenance|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ intravenous PPX every week x 6 weeks for a total of 6 treatments~PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum."
246768|NCT01401959|B4|Baseline|Total|Total of all reporting groups
246769|NCT01401959|B3|Baseline|Cohort C: HER2-positive Breast Cancer Patients|Patients with HER2-postive breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route. Patients will also concurrently receive trastuzumab 6 mg/kg IV on Day 1 every 21 days.
246770|NCT01401959|B2|Baseline|Cohort B: ER/PR Positive/HER2-negative Breast Cancer Patients|Patients with hormone receptor positive (ER and/or PR positive), HER negative breast cancer breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
246771|NCT01401959|B1|Baseline|Cohort A: Triple-negative Breast Cancer Patients|Patients with triple-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
246804|NCT01401907|O2|Outcome|Standard of Care|Subjects receives standard of care
246805|NCT01401907|O1|Outcome|Early Palliative Care|"Subjects receive standard of care with early palliative care.~early palliative care: patient assigned to the intervention will receive early palliative care along with standard oncology care."
246772|NCT01401959|P3|Participant Flow|Cohort C: HER2-positive Breast Cancer Patients|Patients with HER2-postive breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route. Patients will also concurrently receive trastuzumab 6 mg/kg IV on Day 1 every 21 days.
246773|NCT01401959|P2|Participant Flow|Cohort B: ER/PR Positive/HER2-negative Breast Cancer|Patients with ER positive and/or PR positive, HER-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
246774|NCT01401959|P1|Participant Flow|Cohort A: Triple-negative Breast Cancer Patients|Patients with Triple-Negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
246775|NCT01401959|O3|Outcome|Cohort C: HER2-positive Breast Cancer Patients|Patients with HER2-postive breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route. Patients will also concurrently receive trastuzumab 6 mg/kg IV on Day 1 every 21 days.
246776|NCT01401959|O2|Outcome|Cohort B: ER/PR Positive/HER2-negative Breast Cancer|Patients with ER positive and/or PR positive, HER-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
246777|NCT01401959|O1|Outcome|Cohort A: Triple-negative Breast Cancer Patients|Patients with Triple-Negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
246778|NCT01401959|O3|Outcome|Cohort C: HER2-positive Breast Cancer Patients|Patients with HER2-postive breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route. Patients will also concurrently receive trastuzumab 6 mg/kg IV on Day 1 every 21 days.
246779|NCT01401959|O2|Outcome|Cohort B: ER/PR Positive/HER2-negative Breast Cancer|Patients with ER positive and/or PR positive, HER-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
246780|NCT01401959|O1|Outcome|Cohort A: Triple-negative Breast Cancer Patients|Patients with Triple-Negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
246781|NCT01401959|O3|Outcome|Cohort C: HER2-positive Breast Cancer Patients|Patients with HER2-postive breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route. Patients will also concurrently receive trastuzumab 6 mg/kg IV on Day 1 every 21 days.
246782|NCT01401959|O2|Outcome|Cohort B: ER/PR Positive/HER2-negative Breast Cancer Patients|Patients with hormone receptor positive (ER and/or PR positive), HER negative breast cancer breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
246783|NCT01401959|O1|Outcome|Cohort A: Triple-negative Breast Cancer Patients|Patients with triple-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
246784|NCT01401959|E3|Reported Event|Cohort C: HER2 Positive Breast Cancer|Patients with HER2-postive breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route. Patients will also concurrently receive trastuzumab 6 mg/kg IV on Day 1 every 21 days.
246785|NCT01401959|E2|Reported Event|Cohort B: ER/PR Positive/HER2-negative Breast Cancer|Patients with ER positive and/or PR positive, HER-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
246786|NCT01401959|E1|Reported Event|Cohort A: Triple-negative Breast Cancer|Patients with Triple-Negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
246787|NCT01401907|B3|Baseline|Total|Total of all reporting groups
246788|NCT01401907|B2|Baseline|Standard of Care|Subjects receives standard of care
246789|NCT01401907|B1|Baseline|Early Palliative Care|"Subjects receive standard of care with early palliative care.~early palliative care: patient assigned to the intervention will receive early palliative care along with standard oncology care."
246790|NCT01401907|P2|Participant Flow|Standard of Care|Subjects receives standard of care
246791|NCT01401907|P1|Participant Flow|Early Palliative Care|"Subjects receive standard of care with early palliative care.~early palliative care: patient assigned to the intervention will receive early palliative care along with standard oncology care."
246792|NCT01401907|O2|Outcome|Standard Oncology Care|
246793|NCT01401907|O1|Outcome|Early Palliative Care|
246794|NCT01401907|O2|Outcome|Standard Oncology Care|
246795|NCT01401907|O1|Outcome|Early Palliative Care|
246796|NCT01401907|O2|Outcome|Standard Oncology Care|
246797|NCT01401907|O1|Outcome|Early Palliative Care|
246798|NCT01401907|O2|Outcome|Standard Oncology Care|
246799|NCT01401907|O1|Outcome|Early Palliative Care|
246800|NCT01401907|O2|Outcome|Standard Oncology Care|
246801|NCT01401907|O1|Outcome|Early Palliative Care|
246802|NCT01401907|O2|Outcome|Standard of Care|Subjects receives standard of care
246803|NCT01401907|O1|Outcome|Early Palliative Care|"Subjects receive standard of care with early palliative care.~early palliative care: patient assigned to the intervention will receive early palliative care along with standard oncology care."
246806|NCT01401907|E2|Reported Event|Standard of Care|Subjects receives standard of care
246807|NCT01401907|E1|Reported Event|Early Palliative Care|"Subjects receive standard of care with early palliative care.~early palliative care: patient assigned to the intervention will receive early palliative care along with standard oncology care."
246808|NCT01401842|B3|Baseline|Total|Total of all reporting groups
246809|NCT01401842|B2|Baseline|Stabilization Exercise|Low intensity core stabilization exercise
246810|NCT01401842|B1|Baseline|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
246811|NCT01401842|P2|Participant Flow|Stabilization Exercise|Low intensity core stabilization exercise
246812|NCT01401842|P1|Participant Flow|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
246813|NCT01401842|O2|Outcome|Stabilization Exercise|Low intensity core stabilization exercise
246814|NCT01401842|O1|Outcome|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
246815|NCT01401842|O2|Outcome|Stabilization Exercise|Low intensity core stabilization exercise
246816|NCT01401842|O1|Outcome|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
246817|NCT01401842|O2|Outcome|Stabilization Exercise|Low intensity core stabilization exercise
246818|NCT01401842|O1|Outcome|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
246819|NCT01401842|E2|Reported Event|Stabilization Exercise|Low intensity core stabilization exercise
246820|NCT01401842|E1|Reported Event|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
246821|NCT01401647|B4|Baseline|Total|Total of all reporting groups
246822|NCT01401647|B3|Baseline|Normal Saline|"IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.~Normal saline: 6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists."
246823|NCT01401647|B2|Baseline|Lidocaine|"IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.~Lidocaine: 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists."
246824|NCT01401647|B1|Baseline|Amiodarone|"Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.~amiodarone: 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists."
246825|NCT01401647|P3|Participant Flow|Normal Saline|"IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.~Normal saline: 6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists."
246826|NCT01401647|P2|Participant Flow|Lidocaine|"IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.~Lidocaine: 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists."
246827|NCT01401647|P1|Participant Flow|Amiodarone|"Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.~amiodarone: 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists."
246828|NCT01401647|O3|Outcome|Normal Saline|"IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.~Normal saline: 6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists."
246829|NCT01401647|O2|Outcome|Lidocaine|"IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.~Lidocaine: 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists."
246830|NCT01401647|O1|Outcome|Amiodarone|"Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.~amiodarone: 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists."
246876|NCT01401517|O2|Outcome|40 mg Sodium Nitrite|"40 mg dose, BID~sodium nitrite: 40 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
246877|NCT01401517|O1|Outcome|Placebo|0 mg twice each day for 11 weeks.
246878|NCT01401517|E3|Reported Event|80 mg Sodium Nitrite|"80 mg dose, BID~sodium nitrite: 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
246831|NCT01401647|O3|Outcome|Normal Saline|"IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.~Normal saline: 6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists."
246832|NCT01401647|O2|Outcome|Lidocaine|"IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.~Lidocaine: 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists."
246833|NCT01401647|O1|Outcome|Amiodarone|"Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.~amiodarone: 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists."
246834|NCT01401647|E3|Reported Event|Normal Saline|"IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.~Normal saline: 6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists."
246835|NCT01401647|E2|Reported Event|Lidocaine|"IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.~Lidocaine: 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists."
246836|NCT01401647|E1|Reported Event|Amiodarone|"Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.~amiodarone: 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists."
246837|NCT01401595|B3|Baseline|Total|Total of all reporting groups
246838|NCT01401595|B2|Baseline|Control Subjects|10 control participants completed the baseline screening and SPECT scans.
246839|NCT01401595|B1|Baseline|Night Eaters|31 participants screened and diagnosed with NES attended the baseline treatment session and at least one follow-up appointment.
246840|NCT01401595|P2|Participant Flow|Control Subjects|"At the beginning of the study, control subjects were given a medical history, height and weight was measured, and BMI calculated. Initial outpatient assessment included diary measurement of food intake and nighttime awakenings (and associated food intake) together with psychological testing.~An ADAM SPECT-CT study of SERT binding was conducted which will compare SERT binding of the 10 control subjects with that of the 30 night eating subjects to assess SPECT-CT images of night eaters and controls following up our pilot SPECT study of night eaters and controls."
246841|NCT01401595|P1|Participant Flow|Night Eaters|"Subjects were given a medical history, and height and weight was measured. Initial outpatient assessment included diary measurement of food intake and nighttime awakenings (and associated food intake) together with psychological testing. For women, a pregnancy test was also administered no more than 48 hours before SPECT-CT imaging and the beginning of Lexapro treatment. Lexapro treatment lasted 12 weeks.~escitalopram oxalate: The purpose of this study is to determine the effectiveness of the anti-depressant Lexapro in the treatment of the Night Eating Syndrome. An ADAM SPECT-CT study of SERT binding was conducted which will compare SERT binding in 30 night eaters with that of 10 controls. The first procedure assessed SPECT-CT images of night eaters and controls. Medication was administered starting at 10 mg daily, with increases up to 20 mg, as indicated and tolerated, for up to three months. Visits occured at baseline and weeks 1, 2, 4, 6, 8, 10, and 12."
246842|NCT01401595|O2|Outcome|Controls|The controls did not participate in the escitalopram treatment portion of the study. The just completed the baseline screening and SPECT scan.
246843|NCT01401595|O1|Outcome|Night Eating Syndrome Open Label Escitalopram Treatment|All NES subjects received the open label escitalopram treatment
246844|NCT01401595|O2|Outcome|Controls|The controls did not participate in the escitalopram treatment portion of the study. The just completed the baseline screening and SPECT scan.
246845|NCT01401595|O1|Outcome|Night Eating Syndrome Open Label Escitalopram Treatment|All NES subjects received the open label escitalopram treatment
246846|NCT01401595|O2|Outcome|Controls|The control participants did not participate in the treatment part of the study - only the baseline SPECT scans.
246847|NCT01401595|O1|Outcome|Night Eating Syndrome Open Label Escitalopram Treatment|All subjects with NES participated in the open label treatment with escitalopram, although of the 32 participants, 1 did not return after her initial medication visit. As it is unknown if this participants started the medication, only the 31 participants who returned to a second visit or more were included in the analysis
246848|NCT01401595|E1|Reported Event|Night Eating Syndrome Open Label Treatment Group|Only the 32 participants with NES participated in the open label escitalopram treatment trial. One participant did not return after the first visit, and it is unknown if she ever started the medication. Thus 31 participants were included in the statistical analyses.
246849|NCT01401582|B3|Baseline|Total|Total of all reporting groups
246879|NCT01401517|E2|Reported Event|40 mg Sodium Nitrite|"40 mg dose, BID~sodium nitrite: 40 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
246880|NCT01401517|E1|Reported Event|Placebo|sodium nitrite: 0 mg twice each day for 11 weeks .
246881|NCT01401478|B1|Baseline|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
246850|NCT01401582|B2|Baseline|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system~Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers.~published in Thyrian et al. (2016). Journal of Alzheimer´s Disease (52); 69-617."
246851|NCT01401582|B1|Baseline|Care as Usual|"care as usual, no intervention, just observation of natural change/ trajectories over time~published in Thyrian et al. (2016). Journal of Alzheimer´s Disease (52); 69-617."
246852|NCT01401582|P2|Participant Flow|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system~Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers."
246853|NCT01401582|P1|Participant Flow|Care as Usual|care as usual, no intervention, just observation of natural change/ trajectories over time
246854|NCT01401582|O2|Outcome|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system~Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers."
246855|NCT01401582|O1|Outcome|Care as Usual|care as usual, no intervention, just observation of natural change/ trajectories over time
246856|NCT01401582|O2|Outcome|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system~Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers.~published in Thyrian et al. (2016). Journal of Alzheimer´s Disease (52); 69-617."
246857|NCT01401582|O1|Outcome|Care as Usual|"care as usual, no intervention, just observation of natural change/ trajectories over time~published in Thyrian et al. (2016). Journal of Alzheimer´s Disease (52); 69-617."
246858|NCT01401582|O2|Outcome|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system~Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers."
246859|NCT01401582|O1|Outcome|Care as Usual|care as usual, no intervention, just observation of natural change/ trajectories over time
246860|NCT01401582|O2|Outcome|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system~Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers.~published in Thyrian et al. (2016). Journal of Alzheimer´s Disease (52); 69-617."
246861|NCT01401582|O1|Outcome|Care as Usual|"care as usual, no intervention, just observation of natural change/ trajectories over time~published in Thyrian et al. (2016). Journal of Alzheimer´s Disease (52); 69-617."
246862|NCT01401582|O2|Outcome|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system~Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers."
246863|NCT01401582|O1|Outcome|Care as Usual|care as usual, no intervention, just observation of natural change/ trajectories over time
246864|NCT01401582|O2|Outcome|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system~Implementation of Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers."
246865|NCT01401582|O1|Outcome|Care as Usual|care as usual, no intervention, just observation of natural change/ trajectories over time
246866|NCT01401582|E2|Reported Event|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system~Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers."
246867|NCT01401582|E1|Reported Event|Care as Usual|care as usual, no intervention, just observation of natural change/ trajectories over time
246868|NCT01401517|B4|Baseline|Total|Total of all reporting groups
246869|NCT01401517|B3|Baseline|80 mg Sodium Nitrite|"80 mg dose, BID~sodium nitrite: 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
246870|NCT01401517|B2|Baseline|40 mg Sodium Nitrite|"40 mg dose, BID~40 mg sodium nitrite: 40 twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
246871|NCT01401517|B1|Baseline|Placebo|Placebo twice each day for 11 weeks
246872|NCT01401517|P3|Participant Flow|80 mg Sodium Nitrite|"80 mg dose, BID~sodium nitrite: 0, 40 or 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
246873|NCT01401517|P2|Participant Flow|40 mg Sodium Nitrite|"40 mg dose, BID~sodium nitrite: 0, 40 or 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
246874|NCT01401517|P1|Participant Flow|Placebo|sodium nitrite: 0, 40 or 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose.
246875|NCT01401517|O3|Outcome|80 mg Sodium Nitrite|"80 mg dose, BID~sodium nitrite:80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
246949|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
246882|NCT01401478|P1|Participant Flow|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
246883|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
246884|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
246885|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
246886|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
246887|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
246888|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
246889|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
246890|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
246891|NCT01401478|E1|Reported Event|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
246892|NCT01401465|B3|Baseline|Total|Total of all reporting groups
246893|NCT01401465|B2|Baseline|Sequence MOM / CIC|Sequence MOM/CIC: Treatment Period 1 = mometasone nasal inhalation 200 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = ciclesonide Nasal aerosol 74 mcg once daily for two weeks
246894|NCT01401465|B1|Baseline|Sequence CIC / MOM|Sequence CIC/MOM: Treatment Period 1 = ciclesonide nasal aerosol 74 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = mometasone nasal inhalation 200 mcg once daily for two weeks
246895|NCT01401465|P2|Participant Flow|MOM / CIC|Sequence MOM/CIC: Treatment Period 1 = mometasone nasal inhalation 200 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = ciclesonide Nasal aerosol 74 mcg once daily for two weeks
246896|NCT01401465|P1|Participant Flow|CIC / MOM|Sequence CIC/MOM: Treatment Period 1 = ciclesonide nasal aerosol 74 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = mometasone nasal inhalation 200 mcg once daily for two weeks
246897|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
246898|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
246899|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
246900|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
246901|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
246902|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
246903|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
246904|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
246905|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg once daily
246906|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg once daily
246907|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg once daily
246908|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg once daily
246909|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg once daily
246910|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg once daily
246911|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
246912|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
246913|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
246914|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
246915|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
246916|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
246917|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
246918|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
246919|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
246920|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
246921|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
246922|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
246923|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
246924|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
246925|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
246926|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
246927|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
246928|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
246929|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
246930|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
246931|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
246932|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
246933|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
246934|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
246935|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
246936|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
246937|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
246938|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
246939|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
246940|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
246941|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
246942|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
246943|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
246944|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
246945|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
246946|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
246947|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
246948|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
246955|NCT01401465|O1|Outcome|Ciclesonide Versus Mometasone|This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide
246956|NCT01401465|E2|Reported Event|Mometasone|Mometasone AQ 200 mcg
246957|NCT01401465|E1|Reported Event|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
246958|NCT01401452|B1|Baseline|Participants With Psoriasis and at Least One Co-morbid Disease|Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
246959|NCT01401452|P1|Participant Flow|Participants With Psoriasis and at Least One Co-morbid Disease|Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
246960|NCT01401452|O1|Outcome|Participants With Psoriasis and at Least One Co-morbid Disease|Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
246961|NCT01401452|O1|Outcome|Participants With Psoriasis and at Least One Co-morbid Disease|Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
246962|NCT01401452|O1|Outcome|Participants With Psoriasis and at Least One Co-morbid Disease|Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
246963|NCT01401452|O1|Outcome|Participants With Psoriasis and at Least One Co-morbid Disease|Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
246964|NCT01401452|O1|Outcome|Participants With Psoriasis and at Least One Co-morbid Disease|Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
246965|NCT01401452|O1|Outcome|Participants With Psoriasis and at Least One Co-morbid Disease|Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
246966|NCT01401452|O1|Outcome|Participants With Psoriasis and at Least One Co-morbid Disease|Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
246967|NCT01401452|O1|Outcome|Participants With Psoriasis and at Least One Co-morbid Disease|Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
246968|NCT01401452|O1|Outcome|Participants With Psoriasis and at Least One Co-morbid Disease|Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
246969|NCT01401452|E1|Reported Event|Participants With Psoriasis and at Least One Co-morbid Disease|Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
246970|NCT01401361|B1|Baseline|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
246971|NCT01401361|P1|Participant Flow|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
246972|NCT01401361|O1|Outcome|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
246973|NCT01401361|O1|Outcome|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
246974|NCT01401361|O1|Outcome|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
246975|NCT01401361|E1|Reported Event|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
246976|NCT01401322|B1|Baseline|Lenalidomide 50 mg/Day x 28 Days|Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.
247751|NCT01398514|E1|Reported Event|Active Medication|Escitalopram 10mg/day
246977|NCT01401322|P1|Participant Flow|Lenalidomide 50 mg/Day x 28 Days|Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.
246978|NCT01401322|O1|Outcome|Lenalidomide 50 mg/Day x 28 Days|"Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.~Lenalidomide: 50 mg; po"
246979|NCT01401322|E1|Reported Event|Lenalidomide 50 mg/Day x 28 Days|Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.
246980|NCT01401283|B3|Baseline|Total|Total of all reporting groups
246981|NCT01401283|B2|Baseline|Control Group|hemodynamic management according to institutional clinical standards
246982|NCT01401283|B1|Baseline|Study Group|"intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation~measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation"
246983|NCT01401283|P2|Participant Flow|Control Group|hemodynamic management according to institutional clinical standards
246984|NCT01401283|P1|Participant Flow|Study Group|"intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation~measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation"
246985|NCT01401283|O2|Outcome|Control Group|hemodynamic management according to institutional clinical standards
246986|NCT01401283|O1|Outcome|Study Group|"intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation~measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation"
246987|NCT01401283|O2|Outcome|Control Group|hemodynamic management according to institutional clinical standards
246988|NCT01401283|O1|Outcome|Study Group|"intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation~measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation"
246989|NCT01401283|E2|Reported Event|Control Group|hemodynamic management according to institutional clinical standards
246990|NCT01401283|E1|Reported Event|Study Group|"intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation~measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation"
246991|NCT01401257|B5|Baseline|Total|Total of all reporting groups
246992|NCT01401257|B4|Baseline|Placebo|"Oral Liquid formulation, bid, 12 months~Placebo: Liquid,5 ml, twice a day, 12-month treatment"
246993|NCT01401257|B3|Baseline|PXT3003 High Dose|"Oral Liquid formulation, 1/10, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
246994|NCT01401257|B2|Baseline|PXT3003 Intermediate Dose|"Oral Liquid formulation, 1/50, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
246995|NCT01401257|B1|Baseline|PXT3003 Low Dose|"Oral Liquid formulation, 1/100, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
246996|NCT01401257|P4|Participant Flow|Placebo|"Oral Liquid formulation, bid, 12 months~Placebo: Liquid,5 ml, twice a day, 12-month treatment"
246997|NCT01401257|P3|Participant Flow|PXT3003 High Dose|"Oral Liquid formulation, 1/10, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
246998|NCT01401257|P2|Participant Flow|PXT3003 Intermediate Dose|"Oral Liquid formulation, 1/50, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
246999|NCT01401257|P1|Participant Flow|PXT3003 Low Dose|"Oral Liquid formulation, 1/100, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
247000|NCT01401257|O4|Outcome|Placebo|"Oral Liquid formulation, bid, 12 months~Placebo: Liquid,5 ml, twice a day, 12-month treatment"
247001|NCT01401257|O3|Outcome|PXT3003 High Dose|"Oral Liquid formulation, 1/10, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
247002|NCT01401257|O2|Outcome|PXT3003 Intermediate Dose|"Oral Liquid formulation, 1/50, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
247003|NCT01401257|O1|Outcome|PXT3003 Low Dose|"Oral Liquid formulation, 1/100, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
247004|NCT01401257|E4|Reported Event|Placebo|"Oral Liquid formulation, bid, 12 months~Placebo: Liquid,5 ml, twice a day, 12-month treatment"
247005|NCT01401257|E3|Reported Event|PXT3003 High Dose|"Oral Liquid formulation, 1/10, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
247006|NCT01401257|E2|Reported Event|PXT3003 Intermediate Dose|"Oral Liquid formulation, 1/50, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
247007|NCT01401257|E1|Reported Event|PXT3003 Low Dose|"Oral Liquid formulation, 1/100, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
247008|NCT01401166|B3|Baseline|Total|Total of all reporting groups
247009|NCT01401166|B2|Baseline|Cohort 2 Overall: SC (Vial) and IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via handheld syringe using the vial formulation for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received SC Herceptin for up to 10 remaining cycles. Administration was performed by HCP throughout the study. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given.
247028|NCT01401166|O3|Outcome|Cohort 2: SC (Vial) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
265240|NCT01344460|O1|Outcome|Computed Tomographic Angiography (CTA)|
247010|NCT01401166|B1|Baseline|Cohort 1 Overall: SC (SID) and IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given.
247011|NCT01401166|P4|Participant Flow|Cohort 2: IV Then SC (Vial) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
247012|NCT01401166|P3|Participant Flow|Cohort 2: SC (Vial) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
247013|NCT01401166|P2|Participant Flow|Cohort 1: IV Then SC (SID) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
247014|NCT01401166|P1|Participant Flow|Cohort 1: SC (SID) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via single-use injection device (SID), and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by healthcare professional (HCP). Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 milligrams (mg) for all cycles where SC Herceptin was given, and the IV dose was 6 milligrams per kilogram (mg/kg) for all cycles where IV Herceptin was given.
247015|NCT01401166|O2|Outcome|Cohort 1: IV Then SC (SID) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
247016|NCT01401166|O1|Outcome|Cohort 1: SC (SID) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
247017|NCT01401166|O2|Outcome|Cohort 1: IV Then SC (SID) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
247018|NCT01401166|O1|Outcome|Cohort 1: SC (SID) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
247807|NCT01398176|E2|Reported Event|6 Ounces of Mushrooms|6 ounces of mushrooms consumed daily for 4 weeks
247019|NCT01401166|O4|Outcome|Cohort 2: IV Then SC (Vial) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
247020|NCT01401166|O3|Outcome|Cohort 2: SC (Vial) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
247021|NCT01401166|O2|Outcome|Cohort 1: IV Then SC (SID) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
247022|NCT01401166|O1|Outcome|Cohort 1: SC (SID) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
247023|NCT01401166|O4|Outcome|Cohort 2: IV Then SC (Vial) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
247024|NCT01401166|O3|Outcome|Cohort 2: SC (Vial) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
247025|NCT01401166|O2|Outcome|Cohort 1: IV Then SC (SID) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
247026|NCT01401166|O1|Outcome|Cohort 1: SC (SID) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
247027|NCT01401166|O4|Outcome|Cohort 2: IV Then SC (Vial) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
247038|NCT01401166|E9|Reported Event|Cohort 2: SC (Vial) Herceptin (Continuation)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP.
247268|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247029|NCT01401166|O2|Outcome|Cohort 1: IV Then SC (SID) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
247030|NCT01401166|O1|Outcome|Cohort 1: SC (SID) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
247031|NCT01401166|O1|Outcome|All HCPs: SC and IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID (Cohort 1) or vial (Cohort 2) for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin (Cohort 1) or SC Herceptin (Cohort 2) for up to 10 remaining cycles. Participants in Cohort 1 with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered to self-administer SC Herceptin via SID under the direction of a trained HCP, whereas in Cohort 2, administration was performed by HCP throughout the study. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for both SID and vial.
247032|NCT01401166|O1|Outcome|All HCPs: SC and IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID (Cohort 1) or vial (Cohort 2) for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin (Cohort 1) or SC Herceptin (Cohort 2) for up to 10 remaining cycles. Participants in Cohort 1 with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered to self-administer SC Herceptin via SID under the direction of a trained HCP, whereas in Cohort 2, administration was performed by HCP throughout the study. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for both SID and vial.
247033|NCT01401166|O4|Outcome|Cohort 2: IV Then SC (Vial) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
247034|NCT01401166|O3|Outcome|Cohort 2: SC (Vial) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
247035|NCT01401166|O2|Outcome|Cohort 1: IV Then SC (SID) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
247036|NCT01401166|O1|Outcome|Cohort 1: SC (SID) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
247037|NCT01401166|E10|Reported Event|Cohort 2 Overall: SC (Vial) and IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via handheld syringe using the vial formulation for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received SC Herceptin for up to 10 remaining cycles. Administration was performed by HCP throughout the study. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given.
247039|NCT01401166|E8|Reported Event|Cohort 2: IV Herceptin (Continuation)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. In the continuation period, participants were planned to receive SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. However, under protocol deviation a small number of participants received IV Herceptin as a 6-mg/kg dose for this period. Administration was performed by HCP.
247040|NCT01401166|E7|Reported Event|Cohort 2: IV Herceptin (Crossover)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. IV Herceptin was given as a 6-mg/kg dose during four consecutive cycles of the crossover period. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg (instead of 6 mg/kg) for de novo participants who started Herceptin treatment in the study. Administration was performed by HCP.
247041|NCT01401166|E6|Reported Event|Cohort 2: SC (Vial) Herceptin (Crossover)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. SC Herceptin was administered via handheld syringe using the vial formulation as a 600-mg dose during four consecutive cycles of the crossover period. Administration was performed by HCP.
247042|NCT01401166|E5|Reported Event|Cohort 1 Overall: SC (SID) and IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given.
247043|NCT01401166|E4|Reported Event|Cohort 1: SC (SID) Herceptin (Continuation)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID as a 600-mg dose under the direction of a trained HCP.
247044|NCT01401166|E3|Reported Event|Cohort 1: IV Herceptin (Continuation)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. In the continuation period, participants received IV Herceptin as a 6-mg/kg dose for up to 10 remaining cycles. Administration was performed by HCP.
247045|NCT01401166|E2|Reported Event|Cohort 1: IV Herceptin (Crossover)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. IV Herceptin was given as a 6-mg/kg dose during four consecutive cycles of the crossover period. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg (instead of 6 mg/kg) for de novo participants who started Herceptin treatment in the study. Administration was performed by HCP.
247046|NCT01401166|E1|Reported Event|Cohort 1: SC (SID) Herceptin (Crossover)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. SC Herceptin was administered via SID as a 600-mg dose during four consecutive cycles of the crossover period. Administration was performed by HCP.
247047|NCT01401153|B3|Baseline|Total|Total of all reporting groups
247048|NCT01401153|B2|Baseline|Skipping Lunch|No lunch (water)
247049|NCT01401153|B1|Baseline|Having Lunch|Lunch ad libitum (pasta Bolognese, apple and water)
247050|NCT01401153|P2|Participant Flow|Skipping Lunch|No lunch (water)
247051|NCT01401153|P1|Participant Flow|Having Lunch|Lunch ad libitum (pasta Bolognese, apple and water)
247052|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
247053|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
247054|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
247055|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
247056|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
247057|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
247058|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
247059|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
247060|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
247061|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
247062|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
247063|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
247064|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
247065|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
247066|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
247067|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
247068|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
247069|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
247070|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water) o
247071|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
247072|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
247073|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
247074|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
247075|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
247076|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
247077|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
247078|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
247079|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
247080|NCT01401153|E2|Reported Event|Skipping Lunch|No lunch (water)
247081|NCT01401153|E1|Reported Event|Having Lunch|Lunch ad libitum
247082|NCT01401101|B3|Baseline|Total|Total of all reporting groups
247083|NCT01401101|B2|Baseline|Treatment-as-Usual (TAU)|"The TAU condition will consist of only the clinician education and patient screening without written feedback.~Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback."
247101|NCT01401062|O1|Outcome|Arm 1 (Fresolimumab 1 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).~Fresolimumab~Radiation Therapy"
247084|NCT01401101|B1|Baseline|PTSD Care Management (PCM)|"There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.~quality improvement: Care Manager (CM) intervention"
247085|NCT01401101|P2|Participant Flow|Treatment-as-Usual (TAU)|"The TAU condition will consist of only the clinician education and patient screening without written feedback.~Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback."
247086|NCT01401101|P1|Participant Flow|PTSD Care Management (PCM)|"There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.~quality improvement: Care Manager (CM) intervention"
247087|NCT01401101|O2|Outcome|Treatment-as-Usual (TAU)|"The TAU condition will consist of only the clinician education and patient screening without written feedback.~Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback."
247088|NCT01401101|O1|Outcome|PTSD Care Management (PCM)|"There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.~quality improvement: Care Manager (CM) intervention"
247089|NCT01401101|O2|Outcome|Treatment-as-Usual (TAU)|"The TAU condition will consist of only the clinician education and patient screening without written feedback.~Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback."
247090|NCT01401101|O1|Outcome|PTSD Care Management (PCM)|"There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.~quality improvement: Care Manager (CM) intervention"
247091|NCT01401101|O2|Outcome|Treatment-as-Usual (TAU)|"The TAU condition will consist of only the clinician education and patient screening without written feedback.~Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback."
247092|NCT01401101|O1|Outcome|PTSD Care Management (PCM)|"There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.~quality improvement: Care Manager (CM) intervention"
247093|NCT01401101|E2|Reported Event|Treatment-as-Usual (TAU)|The TAU condition consists of only the clinician education and patient screening without written feedback.
247094|NCT01401101|E1|Reported Event|PTSD Care Management (PCM)|There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.
247095|NCT01401062|B3|Baseline|Total|Total of all reporting groups
247096|NCT01401062|B2|Baseline|Arm 2 (Fresolimumab 10 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).~Fresolimumab~Radiation Therapy"
247097|NCT01401062|B1|Baseline|Arm 1 (Fresolimumab 1 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).~Fresolimumab~Radiation Therapy"
247098|NCT01401062|P2|Participant Flow|Arm 2 (Fresolimumab 10 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).~Fresolimumab~Radiation Therapy"
247099|NCT01401062|P1|Participant Flow|Arm 1 (Fresolimumab 1 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).~Fresolimumab~Radiation Therapy"
247100|NCT01401062|O2|Outcome|Arm 2 (Fresolimumab 10 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).~Fresolimumab~Radiation Therapy"
247408|NCT01400243|O2|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
247102|NCT01401062|E2|Reported Event|Arm 2 (Fresolimumab 10 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).~Fresolimumab~Radiation Therapy"
247103|NCT01401062|E1|Reported Event|Arm 1 (Fresolimumab 1 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).~Fresolimumab~Radiation Therapy"
247104|NCT01401049|B3|Baseline|Total|Total of all reporting groups
247105|NCT01401049|B2|Baseline|Propofol/Lidocaine|"The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).~Propofol/Lidocaine: We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion)."
247106|NCT01401049|B1|Baseline|Fospropofol|"To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.~Fospropofol: To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control."
247107|NCT01401049|P2|Participant Flow|Propofol/Lidocaine|"The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).~Propofol/Lidocaine: We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion)."
247108|NCT01401049|P1|Participant Flow|Fospropofol|"To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.~Fospropofol: To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control."
247109|NCT01401049|O2|Outcome|Propofol/Lidocaine|"The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).~Propofol/Lidocaine: We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion)."
247110|NCT01401049|O1|Outcome|Fospropofol|"To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.~Fospropofol: To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control."
247111|NCT01401049|O2|Outcome|Propofol/Lidocaine|"The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).~Propofol/Lidocaine: We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion)."
247112|NCT01401049|O1|Outcome|Fospropofol|"To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.~Fospropofol: To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control."
247113|NCT01401049|E2|Reported Event|Propofol/Lidocaine|"The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).~Propofol/Lidocaine: We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion)."
247114|NCT01401049|E1|Reported Event|Fospropofol|"To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.~Fospropofol: To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control."
247115|NCT01401023|B1|Baseline|CDAD Patient|"Open non-comparative trial~Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
247116|NCT01401023|P1|Participant Flow|Clostridium Difficile Patient|"Open non-comparative trial~Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
247117|NCT01401023|O1|Outcome|Clostridium Difficile Patient|"Open non-comparative trial~Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
247118|NCT01401023|O1|Outcome|Clostridium Difficile Patient|"Open non-comparative trial~Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
247119|NCT01401023|O1|Outcome|Clostridium Difficile Patient|"Open non-comparative trial~Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
247120|NCT01401023|E1|Reported Event|CDAD Patient|"Open non-comparative trial~Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
247121|NCT01401010|B3|Baseline|Total|Total of all reporting groups
247122|NCT01401010|B2|Baseline|Doripenem 1000 mg|pharmacokinetics/pharmacodynamics
247123|NCT01401010|B1|Baseline|Doripenem 500 mg|pharmacokinetics/pharmacodynamics
247124|NCT01401010|P2|Participant Flow|Doripenem 1000 mg|pharmacokinetics/pharmacodynamics
247125|NCT01401010|P1|Participant Flow|Doripenem 500 mg|pharmacokinetics/pharmacodynamics
247126|NCT01401010|O3|Outcome|Combined Results for Both 500 and 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Combined Results
247127|NCT01401010|O2|Outcome|Doripenem 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 1000 mg Dosing
247128|NCT01401010|O1|Outcome|Doripenem 500 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 500mg Dosing
247129|NCT01401010|O3|Outcome|Combined Results for Both 500 and 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Combined Results
247130|NCT01401010|O2|Outcome|Doripenem 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 1000 mg Dosing
247131|NCT01401010|O1|Outcome|Doripenem 500 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 500mg Dosing
247132|NCT01401010|O3|Outcome|Combined Results for Both 500 and 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Combined Results
247133|NCT01401010|O2|Outcome|Doripenem 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 1000 mg Dosing
247134|NCT01401010|O1|Outcome|Doripenem 500 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 500mg Dosing
247135|NCT01401010|O3|Outcome|Combined Results for Both 500 and 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Combined Results
247136|NCT01401010|O2|Outcome|Doripenem 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 1000 mg Dosing
247137|NCT01401010|O1|Outcome|Doripenem 500 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 500mg Dosing
247138|NCT01401010|O4|Outcome|1000 mg Doripenem 4 Hour Infusion|Probability of target attainment (40%fT>MIC) against Gram-negative pathogens using Monte Carlo simulations
247139|NCT01401010|O3|Outcome|1000 mg Doripenem 1 Hour Infusion|Probability of target attainment (40%fT>MIC) against Gram-negative pathogens using Monte Carlo simulations
247140|NCT01401010|O2|Outcome|500 mg Doripenem 4 Hour Infusion|Probability of target attainment (40%fT>MIC) against Gram-negative pathogens using Monte Carlo simulations
247141|NCT01401010|O1|Outcome|500 mg Doripenem 1 Hour Infusion|Probability of target attainment (40%fT>MIC) against Gram-negative pathogens using Monte Carlo simulations
247142|NCT01401010|O3|Outcome|Combined Results for Both 500 and 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Combined Results
247143|NCT01401010|O2|Outcome|Doripenem 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 1000 mg Dosing
247144|NCT01401010|O1|Outcome|Doripenem 500 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 500mg Dosing
247145|NCT01401010|E2|Reported Event|Doripenem 1000 mg|pharmacokinetics/pharmacodynamics
247146|NCT01401010|E1|Reported Event|Doripenem 500 mg|pharmacokinetics/pharmacodynamics
247147|NCT01400958|B3|Baseline|Total|Total of all reporting groups
247148|NCT01400958|B2|Baseline|Placebo Comparator: B: Placebo|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
247149|NCT01400958|B1|Baseline|Active Comparator: A: Nuvigil®|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
247150|NCT01400958|P2|Participant Flow|Placebo Comparator: B: Placebo|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
247169|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
247170|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
247151|NCT01400958|P1|Participant Flow|Active Comparator: A: Nuvigil®|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
247152|NCT01400958|O2|Outcome|Placebo Comparator: B: Placebo|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
247153|NCT01400958|O1|Outcome|Active Comparator: A: Nuvigil®|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
247154|NCT01400958|O2|Outcome|Placebo Comparator: B: Placebo|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
247155|NCT01400958|O1|Outcome|Active Comparator: A: Nuvigil®|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
247156|NCT01400958|E2|Reported Event|Placebo Comparator: B: Placebo|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
247157|NCT01400958|E1|Reported Event|Active Comparator: A: Nuvigil®|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
247158|NCT01400932|B3|Baseline|Total|Total of all reporting groups
247159|NCT01400932|B2|Baseline|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
247160|NCT01400932|B1|Baseline|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
247161|NCT01400932|P2|Participant Flow|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
247162|NCT01400932|P1|Participant Flow|GI148512|Participants applied 2 finger tip units (FTU) of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
247163|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
247164|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
247165|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
247166|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
247167|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
247168|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
247171|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
247172|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
247173|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
247174|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
247175|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
247176|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
247177|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
247178|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
247179|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
247180|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
247181|NCT01400932|E2|Reported Event|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
247182|NCT01400932|E1|Reported Event|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
247183|NCT01400919|B1|Baseline|Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems|"The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.: Implantation of one or more study devices in the common and/or external iliac artery."
247184|NCT01400919|P1|Participant Flow|Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems|"The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.: Implantation of one or more study devices in the common and/or external iliac artery."
247185|NCT01400919|O1|Outcome|Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems|"The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.: Implantation of one or more study devices in the common and/or external iliac artery."
247186|NCT01400919|E1|Reported Event|Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems|"The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.: Implantation of one or more study devices in the common and/or external iliac artery."
247187|NCT01400906|B1|Baseline|Placebo, FP 100 µg, and FP 500 µg in 1 of 6 Sequences|All participants received one of the following three treatments in one of three treatment periods, one inhalation in the morning and evening from Day 1 to 6 and one inhalation on the morning on Day 7, from the Dry Powder Inhaler (DPI): Placebo; Fluticasone propionate (FP) 100 micrograms (µg); and FP 500 µg. Participants were randomized to receive treatment in one of the six following sequences: (1) Placebo, FP 100 µg, FP 500 µg; (2) Placebo, FP 500 µg, FP 100 µg; (3) FP 100 µg, Placebo, FP 500 µg; (4) FP 100 µg, FP 500 µg, Placebo; (5) FP 500 µg, Placebo, FP 100 µg; (6) FP 500 µg, FP 100 µg, Placebo. The three treatment periods were separated by a washout period of 14 days.
247188|NCT01400906|P6|Participant Flow|Sequence 6: FP 500 µg, FP 100 µg, Placebo|Participants received FP 500 µg, FP 100 µg, and Placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
247189|NCT01400906|P5|Participant Flow|Sequence 5: FP 500 µg, Placebo, FP 100 µg|Participants received FP 500 µg, Placebo, and FP 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
247190|NCT01400906|P4|Participant Flow|Sequence 4: FP 100 µg, FP 500 µg, Placebo|Participants received FP 100 µg, FP 500 µg, and Placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
247409|NCT01400243|O1|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
265241|NCT01344460|O2|Outcome|Unenhanced MRA|
247191|NCT01400906|P3|Participant Flow|Sequence 3: FP 100 µg, Placebo, FP 500 µg|Participants received FP 100 µg, Placebo, and FP 500 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
247192|NCT01400906|P2|Participant Flow|Sequence 2: Placebo, FP 500 µg, FP 100 µg|Participants received Placebo, FP 500 µg, and FP 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
247193|NCT01400906|P1|Participant Flow|Sequence 1: Placebo, FP 100 µg, FP 500 µg|Participants received placebo, Fluticasone Propionate (FP) 100 micrograms (µg), and FP 500 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the Dry Powder Inhaler (DPI). The three treatment periods were separated by a washout period of 14 days.
247194|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247195|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247196|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247197|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247198|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247199|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247200|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247201|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247202|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247203|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247204|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247205|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247206|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247207|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247208|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247209|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247210|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247211|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247212|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247410|NCT01400243|O2|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
247213|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247214|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247215|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247216|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247217|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247218|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247219|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247220|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247221|NCT01400906|E3|Reported Event|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247222|NCT01400906|E2|Reported Event|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247223|NCT01400906|E1|Reported Event|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
247224|NCT01400893|B3|Baseline|Total|Total of all reporting groups
247225|NCT01400893|B2|Baseline|CRRT Alone|Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized.
247226|NCT01400893|B1|Baseline|CRRT + SCD|"Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized.~SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits."
247227|NCT01400893|P2|Participant Flow|CRRT Alone|Patients with a diagnosis of acute kidney injury and multiorgan failure requiring CRRT will be randomized
247228|NCT01400893|P1|Participant Flow|CRRT + SCD|"Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized~SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits."
247229|NCT01400893|O2|Outcome|CRRT Alone|Patients with a diagnosis of AKI will be randomized
247230|NCT01400893|O1|Outcome|CRRT + SCD|"Patients with a diagnosis of AKI will be randomized~SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits."
247231|NCT01400893|O2|Outcome|CRRT Alone|Patients with a diagnosis of AKI requires CRRT will be randomized
247232|NCT01400893|O1|Outcome|CRRT + SCD|"Patients with a diagnosis of AKI requires CRRT will be randomized~SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits."
247233|NCT01400893|E2|Reported Event|CRRT Alone|Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized.
247266|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247267|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247411|NCT01400243|O1|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
247234|NCT01400893|E1|Reported Event|CRRT + SCD|"Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized.~SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits."
247235|NCT01400880|B1|Baseline|Primary|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation
247236|NCT01400880|P1|Participant Flow|Electrode Sensor, TOCO and IUPC|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, TOCO and IUPC
247237|NCT01400880|O1|Outcome|Electrode Sensor, TOCO and IUPC|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation studied with electrode sensor, Tocodynamometer and IUPC
247238|NCT01400880|E1|Reported Event|Primary|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation
247239|NCT01400841|B1|Baseline|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247240|NCT01400841|P1|Participant Flow|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247241|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247242|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247243|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247244|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247245|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247246|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247247|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247248|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247249|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247250|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247251|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247252|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247253|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247254|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247255|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247256|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247257|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247258|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247259|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247260|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247261|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247262|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247263|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247264|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247265|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247269|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247270|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247271|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247272|NCT01400841|E1|Reported Event|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
247273|NCT01400698|B5|Baseline|Total|Total of all reporting groups
247274|NCT01400698|B4|Baseline|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
247275|NCT01400698|B3|Baseline|Final Height: Not Treated|Includes all participants who achieved the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
247276|NCT01400698|B2|Baseline|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
247277|NCT01400698|B1|Baseline|Non-Final Height: Not Treated|Includes all participants who did not achieve the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
247278|NCT01400698|P6|Participant Flow|Observation (C)|Participants with bone age >12 years for girls or 14 years for boys or refused to be treated in any of the above groups were followed without treatment until they reached final height for a maximum duration of 10.6 years.
247279|NCT01400698|P5|Participant Flow|Observed Then Randomized to Observation (B2)|Participants with bone age <=12 years for girls or 14 years for boys and height >-2 SD were observed until first signs of puberty and if remained at a height >-2 SD, were randomized to observation group with no treatment until they reached final height for a maximum duration of 10.6 years. Participants whose height fell to <=-2 SD before the first sign of puberty, were randomized to either Saizen® Continuous (A1) or Saizen® Intermittent (A2) treatment group.
247280|NCT01400698|P4|Participant Flow|Observed Then Randomized to Saizen® (B1)|Participants with bone age <=12 years for girls or 14 years for boys and height >-2 SD were observed until first signs of puberty and if remained at a height >-2 SD, were randomized to receive continuous treatment with r-hGH 0.067 mg/kg/day sc until they reached final height for a maximum duration of 10.6 years. Participants whose height fell to <=-2 SD before the first sign of puberty, were randomized to either Saizen® Continuous (A1) or Saizen® Intermittent (A2) treatment group.
247281|NCT01400698|P3|Participant Flow|Observed, Not Randomized (B0)|Participants with bone age <=12 years for girls or 14 years for boys and height greater than (>) -2 SD were observed until first signs of puberty but not randomized.
247282|NCT01400698|P2|Participant Flow|Saizen® Intermittent (A2)|Participants with bone age <=12 years for girls or 14 years for boys and height <=-2 SD received intermittent treatment with r-hGH 0.067 mg/kg/day sc until they reached final height for a maximum duration of 10.6 years. Intermittent treatment was given on an individual basis depending on the height achieved during the study.
247283|NCT01400698|P1|Participant Flow|Saizen® Continuous (A1)|Participants with bone age less than or equal to (<=) 12 years for girls or 14 years for boys and height <=-2 standard deviation (SD) received continuous treatment with recombinant human Growth Hormone (r-hGH) 0.067 milligram/kilogram/day (mg/kg/day) subcutaneously (sc) until they reached final height for a maximum duration of 10.6 years.
247284|NCT01400698|O4|Outcome|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
247285|NCT01400698|O3|Outcome|Final Height: Not Treated|Includes all participants who achieved the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
247286|NCT01400698|O2|Outcome|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
247287|NCT01400698|O1|Outcome|Non-Final Height: Not Treated|Includes all participants who did not achieve the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
247288|NCT01400698|O2|Outcome|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
247289|NCT01400698|O1|Outcome|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
247290|NCT01400698|O4|Outcome|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
247291|NCT01400698|O3|Outcome|Final Height: Not Treated|Includes all participants who achieved the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
247292|NCT01400698|O2|Outcome|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
247293|NCT01400698|O1|Outcome|Non-Final Height: Not Treated|Includes all participants who did not achieve the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
247294|NCT01400698|O4|Outcome|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
247295|NCT01400698|O3|Outcome|Final Height: Not Treated|Includes all participants who achieved the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
247296|NCT01400698|O2|Outcome|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
247412|NCT01400243|O2|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
247297|NCT01400698|O1|Outcome|Non-Final Height: Not Treated|Includes all participants who did not achieve the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
247298|NCT01400698|O4|Outcome|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
247299|NCT01400698|O3|Outcome|Final Height: Not Treated|Includes all participants who achieved the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
247300|NCT01400698|O2|Outcome|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
247301|NCT01400698|O1|Outcome|Non-Final Height: Not Treated|Includes all participants who did not achieve the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
247302|NCT01400698|E2|Reported Event|Treated|Included all participants who received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
247303|NCT01400698|E1|Reported Event|Not Treated|Included all participants who did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
247304|NCT01400516|B3|Baseline|Total|Total of all reporting groups
247305|NCT01400516|B2|Baseline|Teriparatide|The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
247306|NCT01400516|B1|Baseline|Control Arm|The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
247307|NCT01400516|P2|Participant Flow|Teriparatide|The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
247308|NCT01400516|P1|Participant Flow|Control Arm|The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
247309|NCT01400516|O2|Outcome|Teriparatide|The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
247310|NCT01400516|O1|Outcome|Control Arm|The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
247311|NCT01400516|O2|Outcome|Teriparatide|The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
247312|NCT01400516|O1|Outcome|Control Arm|The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
247313|NCT01400516|O2|Outcome|Teriparatide|The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
247314|NCT01400516|O1|Outcome|Control Arm|The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
247315|NCT01400516|E2|Reported Event|Teriparatide|The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
247316|NCT01400516|E1|Reported Event|Control Arm|The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
247317|NCT01400503|B1|Baseline|Siltuximab|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
247318|NCT01400503|P1|Participant Flow|Siltuximab|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
247319|NCT01400503|O1|Outcome|Siltuximab|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
247320|NCT01400503|O1|Outcome|Siltuximab|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
247413|NCT01400243|O1|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
247321|NCT01400503|O1|Outcome|Siltuximab|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
247322|NCT01400503|O1|Outcome|Siltuximab|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
247323|NCT01400503|O1|Outcome|Siltuximab|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
247324|NCT01400503|O1|Outcome|Siltuximab|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
247325|NCT01400503|E1|Reported Event|Siltuximab|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
247326|NCT01400451|B4|Baseline|Total|Total of all reporting groups
247327|NCT01400451|B3|Baseline|720 mg Vemurafenib|These participants were receiving 720 mg vemurafenib in the Lead in Period prior to starting ipilimumab but after the dose limiting toxicities (DLTs) were identified, ipilimumab was not started. Due to disease stabilization, they continued on 720 mg vemurafenib alone orally twice daily.
247328|NCT01400451|B2|Baseline|3 mg/kg Ipilimumab + 720 mg Vemurafenib|"Lead In Period: 28 Days of 720 mg vemurafenib orally twice daily (starting Day -27 or -13).~Combination Treatment (Induction of ipilimumab) Period: 3 milligrams per kilogram body weight (mg/kg) ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily throughout combination treatment."
247329|NCT01400451|B1|Baseline|3 mg/kg Ipilimumab + 960 mg Vemurafenib|"Lead In Period: 28 Days of 960 mg vemurafenib orally twice daily (starting Day -27 or -13).~Combination Treatment (Induction of ipilimumab) Period: 3 milligrams per kilogram body weight (mg/kg) ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1, plus 960 mg vemurafenib orally twice daily throughout combination treatment."
247330|NCT01400451|P3|Participant Flow|720 mg Vemurafenib|These participants were receiving 720 mg vemurafenib in the Lead in Period prior to starting ipilimumab but after the dose limiting toxicities (DLTs) were identified ipilimumab was not started. Due to disease stabilization, they continued on 720 mg vemurafenib alone orally twice daily. Note: the dose of vemurafenib could be escalated from 720 mg to 960 mg, at the investigator’s discretion.
247331|NCT01400451|P2|Participant Flow|3 mg/kg Ipilimumab + 720 mg Vemurafenib|"Lead In Period: 28 Days of 720 mg vemurafenib orally twice daily (starting Day -27 or -13).~Combination Treatment (Induction of ipilimumab) Period: 3 milligrams per kilogram body weight (mg/kg) ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily throughout combination treatment."
247332|NCT01400451|P1|Participant Flow|3 mg/kg Ipilimumab + 960 mg Vemurafenib|"Lead In Period: 28 Days of 960 mg vemurafenib orally twice daily (starting Day -27 or -13).~Combination Treatment (Induction of ipilimumab) Period: 3 milligrams per kilogram body weight (mg/kg) ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 960 mg vemurafenib orally twice daily throughout combination treatment."
247333|NCT01400451|O2|Outcome|3 mg/kg Ipilimumab + 720 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily continuing during combination treatment.
247334|NCT01400451|O1|Outcome|3 mg/kg Ipilimumab + 960 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 960 mg vemurafenib orally twice daily continuing during combination treatment.
247335|NCT01400451|O2|Outcome|3 mg/kg Ipilimumab + 720 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily continuing during combination treatment.
247336|NCT01400451|O1|Outcome|3 mg/kg Ipilimumab + 960 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 960 mg vemurafenib orally twice daily and continuing during combination treatment.
247337|NCT01400451|O3|Outcome|720 mg Vemurafenib Alone|"These participants were receiving 720 mg vemurafenib in the Lead in Period prior to starting ipilimumab but after the DLTs were identified, ipilimumab was not started. Due to disease stabilization, they continued on 720 mg vemurafenib alone orally twice daily.~Events from first day of vemurafenib to last day of treatment + 90 days, up to date of data cut off for Primary Endpoint."
247338|NCT01400451|O2|Outcome|720 mg Vemurafenib Lead in Period|"Lead In Period: 28 Days of 720 mg vemurafenib orally twice daily (starting Day -27 or -13).~Events between the first vemurafenib dose and the day prior to the first ipilimumab dose."
247339|NCT01400451|O1|Outcome|960 mg Vemurafenib Lead in Period|"Lead In Period: 28 Days of 960 mg vemurafenib orally twice daily (starting Day -27 or -13).~Events between the first vemurafenib dose and the day prior to the first ipilimumab dose."
247340|NCT01400451|E5|Reported Event|3 mg/kg Ipilimumab + 720 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily continuing during combination treatment.
247341|NCT01400451|E4|Reported Event|3 mg/kg Ipilimumab + 960 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 960 mg vemurafenib orally twice daily and continuing during combination treatment.
247342|NCT01400451|E3|Reported Event|Lead- In Period 720 mg Vemurafenib Alone|These participants were receiving 720 mg vemurafenib in the Lead in Period prior to starting ipilimumab but after the DLTs were identified, ipilimumab was not started. Due to disease stabilization, they continued on 720 mg vemurafenib alone orally twice daily.
247343|NCT01400451|E2|Reported Event|Lead-In Period 720 mg Vemurafenib|"Lead In Period: 28 Days of 720 mg vemurafenib orally twice daily (starting Day -27 or -13).~Events between the first vemurafenib dose and the day prior to the first ipilimumab dose."
247810|NCT01397890|B2|Baseline|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247344|NCT01400451|E1|Reported Event|Lead-In Period 960 mg Vemurafenib|"Lead In Period: 28 Days of 960 mg vemurafenib orally twice daily (starting Day -27 or -13).~Events between the first vemurafenib dose and the day prior to the first ipilimumab dose."
247345|NCT01400425|B1|Baseline|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
247346|NCT01400425|P1|Participant Flow|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
247347|NCT01400425|O1|Outcome|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
247348|NCT01400425|O1|Outcome|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
247349|NCT01400425|O1|Outcome|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
247350|NCT01400425|O3|Outcome|Subjects With a Negative Scan|Subjects with progressive cognitive decline that received a negative scan.
247351|NCT01400425|O2|Outcome|Subjectss With a Positive Scan|Subjects with progressive cognitive decline that received a positive florbetapir scan.
247352|NCT01400425|O1|Outcome|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
247353|NCT01400425|O1|Outcome|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
247354|NCT01400425|O1|Outcome|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
247355|NCT01400425|E1|Reported Event|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
247356|NCT01400412|B3|Baseline|Total|Total of all reporting groups
247357|NCT01400412|B2|Baseline|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
247414|NCT01400243|O2|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
247415|NCT01400243|O1|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
247416|NCT01400243|O2|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
247417|NCT01400243|O1|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
265242|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
247358|NCT01400412|B1|Baseline|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
247359|NCT01400412|P2|Participant Flow|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
247360|NCT01400412|P1|Participant Flow|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
247361|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
247362|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
247363|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
247364|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
247365|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
247366|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
247418|NCT01400243|O2|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
247419|NCT01400243|O1|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
247420|NCT01400243|O2|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
247421|NCT01400243|O1|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
247422|NCT01400243|O2|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
247367|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
247368|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
247369|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
247370|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
247371|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
247372|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
247373|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
247374|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
247375|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
247423|NCT01400243|O1|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
247424|NCT01400243|O2|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
247425|NCT01400243|O1|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
247426|NCT01400243|E2|Reported Event|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
248064|NCT01397461|E3|Reported Event|Retapamulin 1% Ointment|"1% ointment~retapamulin 1% ointment: ointment"
247376|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
247377|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
247378|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
247379|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
247380|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
247381|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
247382|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
247383|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
247384|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
247427|NCT01400243|E1|Reported Event|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
247428|NCT01400139|B1|Baseline|HYD Core Study|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
247429|NCT01400139|P1|Participant Flow|Hydrocodone Bitartrate (HYD)|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
265243|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
247385|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
247386|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
247387|NCT01400412|O2|Outcome|TDF Arm: DRV/r + TDF + FTC + MVC Placebo|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one tablet."
247388|NCT01400412|O1|Outcome|MVC Arm: DRV/r + MVC + FTC + TDF Placebo|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.~Maraviroc: Maraviroc was administered orally once a day as one 150 mg tablet."
247389|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
247390|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
247391|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
247392|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
247393|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
247430|NCT01400139|O2|Outcome|HYD Extension Period|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
247431|NCT01400139|O1|Outcome|HYD Core Study|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
248065|NCT01397461|E2|Reported Event|Ozenoxacin Placebo|"cream~ozenoxacin placebo: cream"
247394|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
247395|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
247396|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
247397|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
247398|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
247399|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
247400|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
247401|NCT01400412|E2|Reported Event|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
247402|NCT01400412|E1|Reported Event|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
247403|NCT01400243|B3|Baseline|Total|Total of all reporting groups
247404|NCT01400243|B2|Baseline|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
247405|NCT01400243|B1|Baseline|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
247406|NCT01400243|P2|Participant Flow|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
247407|NCT01400243|P1|Participant Flow|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
247705|NCT01398943|O1|Outcome|All COPD Patients|Patients with COPD
247432|NCT01400139|O2|Outcome|HYD Extension Period|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
247433|NCT01400139|O1|Outcome|HYD Core Study|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
247434|NCT01400139|E2|Reported Event|HYD Extension Period|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
247435|NCT01400139|E1|Reported Event|HYD Core Study|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
247436|NCT01400113|B3|Baseline|Total|Total of all reporting groups
247437|NCT01400113|B2|Baseline|Placebo|60 patients were randomized to this group
247438|NCT01400113|B1|Baseline|Asenapine|60 patients were randomized to this group
247439|NCT01400113|P2|Participant Flow|Placebo|60 patients were randomized to this group
247440|NCT01400113|P1|Participant Flow|Asenapine|60 patients were randomized to this group
247441|NCT01400113|O2|Outcome|Placebo|60 patients were randomized to this group
247442|NCT01400113|O1|Outcome|Asenapine|60 patients were randomized to this group
247443|NCT01400113|E2|Reported Event|Placebo|Placebo: Placebo Sublingual Tablet, single-dose
247444|NCT01400113|E1|Reported Event|Asenapine|Asenapine: Asenapine Sublingual Tablet 10mg, single-dose
247445|NCT01399866|B3|Baseline|Total|Total of all reporting groups
247446|NCT01399866|B2|Baseline|D-cycloserine|"50 mg capsule,single dose, twice, one week apart, by mouth~D-cycloserine: 2 single weekly doses, 50 mg capsule"
247447|NCT01399866|B1|Baseline|Placebo|"50 mg capsule,single dose, twice, one week apart, by mouth~Placebo"
247448|NCT01399866|P2|Participant Flow|D-cycloserine|"50 mg capsule,single dose, twice, one week apart, by mouth~D-cycloserine: 2 single weekly doses, 50 mg capsule"
247449|NCT01399866|P1|Participant Flow|Placebo|"50 mg capsule,single dose, twice, one week apart, by mouth~Placebo"
247450|NCT01399866|O2|Outcome|D-cycloserine|"50 mg capsule,single dose, twice, one week apart, by mouth~D-cycloserine: 2 single weekly doses, 50 mg capsule"
247451|NCT01399866|O1|Outcome|Placebo|"50 mg capsule,single dose, twice, one week apart, by mouth~Placebo"
247452|NCT01399866|O2|Outcome|D-cycloserine|"50 mg capsule,single dose, twice, one week apart, by mouth~D-cycloserine: 2 single weekly doses, 50 mg capsule"
247453|NCT01399866|O1|Outcome|Placebo|"50 mg capsule,single dose, twice, one week apart, by mouth~Placebo"
247454|NCT01399866|O2|Outcome|D-cycloserine|"50 mg capsule,single dose, twice, one week apart, by mouth~D-cycloserine: 2 single weekly doses, 50 mg capsule"
247455|NCT01399866|O1|Outcome|Placebo|"50 mg capsule,single dose, twice, one week apart, by mouth~Placebo"
247456|NCT01399866|O2|Outcome|D-cycloserine|"50 mg capsule,single dose, twice, one week apart, by mouth~D-cycloserine: 2 single weekly doses, 50 mg capsule"
247457|NCT01399866|O1|Outcome|Placebo|"50 mg capsule,single dose, twice, one week apart, by mouth~Placebo"
247458|NCT01399866|O2|Outcome|D-cycloserine|"50 mg capsule,single dose, twice, one week apart, by mouth~D-cycloserine: 2 single weekly doses, 50 mg capsule"
247459|NCT01399866|O1|Outcome|Placebo|"50 mg capsule,single dose, twice, one week apart, by mouth~Placebo"
247460|NCT01399866|O2|Outcome|D-cycloserine|"50 mg capsule,single dose, twice, one week apart, by mouth~D-cycloserine: 2 single weekly doses, 50 mg capsule"
247461|NCT01399866|O1|Outcome|Placebo|"50 mg capsule,single dose, twice, one week apart, by mouth~Placebo"
247462|NCT01399866|E2|Reported Event|D-cycloserine|"50 mg capsule,single dose, twice, one week apart, by mouth~D-cycloserine: 2 single weekly doses, 50 mg capsule"
247463|NCT01399866|E1|Reported Event|Placebo|"50 mg capsule,single dose, twice, one week apart, by mouth~Placebo"
247464|NCT01399788|B1|Baseline|Entire Study Population|Includes participants randomized to receive Myrin-P Forte first and four single drug references first.
247465|NCT01399788|P2|Participant Flow|Four Single Drug References First, Then Myrin-P Forte|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in first intervention period; and single oral dose of 4 FDC tablets of Myrin-P Forte (each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide) in second intervention period. A washout period of at least 1 week was maintained between each period.
247466|NCT01399788|P1|Participant Flow|Myrin-P Forte First, Then Four Single Drug References|Single oral dose of 4 fixed dose combination (FDC) tablets of Myrin-P Forte (each tablet contains 150 milligram (mg) rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide) in first intervention period; and single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in second intervention period. A washout period of at least 1 week was maintained between each period.
247467|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
247468|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
247469|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
247470|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
247471|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
247472|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
247473|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
247474|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
247475|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
247476|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
247477|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
247478|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
247479|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
247480|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
247481|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
247482|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
247483|NCT01399788|E2|Reported Event|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
247484|NCT01399788|E1|Reported Event|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
247485|NCT01399723|B3|Baseline|Total|Total of all reporting groups
247486|NCT01399723|B2|Baseline|Penicillin|Benzyl penicillin 50000 IU 6 hourly
247487|NCT01399723|B1|Baseline|Amoxicillin|Amoxicillin 45mg/kg 12 hourly
247488|NCT01399723|P2|Participant Flow|Benzyl Penicillin 50,000IU/kg 6 Hourly|Benzyl penicillin: Intravenous 50,000IU/kg 6 hourly
247489|NCT01399723|P1|Participant Flow|Amoxicillin 45mg/kg 12 Hourly|Amoxicillin: Oral 45mg/kg 12 hourly
247490|NCT01399723|O2|Outcome|Penicillin|Benzyl Penicillin 50,000IU/kg 6 hourly
247491|NCT01399723|O1|Outcome|Amoxicillin|Amoxicillin 45mg/kg 12 hourly
247492|NCT01399723|O2|Outcome|Penicillin|Benzyl Penicillin 50,000IU/kg 6 hourly
247493|NCT01399723|O1|Outcome|Amoxicillin|Amoxicillin 45mg/kg 12 hourly
247494|NCT01399723|O2|Outcome|Penicillin|Benzyl penicillin 50000 IU/kg 6 hourly
247495|NCT01399723|O1|Outcome|Amoxicillin|Amoxicillin 45mg/kg 12 hourly
247496|NCT01399723|E2|Reported Event|Benzyl Penicillin|Benzyl Penicillin 50,000IU/kg 6 hourly
247497|NCT01399723|E1|Reported Event|Amoxicillin|Amoxicillin 45mg/kg 12 hourly
247498|NCT01399697|B4|Baseline|Total|Total of all reporting groups
247499|NCT01399697|B3|Baseline|TCZ + Placebo (Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules, orally, at stable dose (10, 15, 17.5, or 20 mg per week, but no maximum dose was defined) weekly, from Weeks 1 through 16 followed by matching placebo capsules, orally, weekly through Week 24.
247500|NCT01399697|B2|Baseline|TCZ + MTX (Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg/week, but no maximum dose was defined), weekly, from Weeks 1 through 24.
247501|NCT01399697|B1|Baseline|TCZ + MTX (Not Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules orally, at a stable dose (10, 15, 17.5, or 20 mg, no maximum dose was defined) weekly from Week 1 through 16.
247502|NCT01399697|P3|Participant Flow|TCZ + Placebo (Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules, orally, at stable dose (10, 15, 17.5, or 20 mg per week, but no maximum dose was defined) weekly, from Weeks 1 through 16 followed by matching placebo capsules, orally, weekly through Week 24.
247503|NCT01399697|P2|Participant Flow|TCZ + MTX (Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg/week, but no maximum dose was defined), weekly, from Weeks 1 through 24.
247504|NCT01399697|P1|Participant Flow|Tocilizumab (TCZ) Plus (+) Methotrexate (Not Randomized)|Participants received TCZ 8 milligrams per kilogram (mg/kg; maximum 800 mg) via intravenous (IV) infusion every 4 weeks (q4w) through Week 24 (total of 7 infusions). Participants also received methotrexate (MTX) capsules orally, at a stable dose (10, 15, 17.5, or 20 mg, no maximum dose was defined) weekly from Week 1 through 16.
247505|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
247506|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
247507|NCT01399697|O2|Outcome|Tocilizumab + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
247508|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
247509|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
247510|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
247511|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
247512|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
247513|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
247514|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
247515|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
247516|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
247517|NCT01399697|O2|Outcome|Tocilizumab + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
247518|NCT01399697|O1|Outcome|Tocilizumab + Methotrexate (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
247519|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
247520|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
247521|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
247522|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
247523|NCT01399697|E5|Reported Event|TCZ + Placebo (Post-randomization)|TCZ 8 mg/kg (maximum 800 mg) q4w via IV infusion up to Week 16 (total of 4 infusions). Participants also received MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg/week but no maximum dose was set) weekly, up to Week 16. Participants with a response were randomized to receive 3 additional IV infusions of TCZ 8 mg/kg between Week 16 and Week 24 and matching placebo MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg per week, but no maximum dose was set), weekly through Week 24. Response was defined as participants having DAS28 score <=3.2.
247524|NCT01399697|E4|Reported Event|TCZ + MTX (Post-randomization)|TCZ 8 mg/kg (maximum 800 mg) q4w via IV infusion up to Week 16 (total of 4 infusions). Participants also received MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg/week but no maximum dose was set) weekly, up to Week 16. Participants with a response were randomized to receive 3 additional IV infusions of TCZ 8 mg/kg between Week 16 and Week 24 and MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg per week, but no maximum dose was set), weekly through Week 24. Response was defined as participants having DAS28 score <=3.2.
247525|NCT01399697|E3|Reported Event|TCZ + Placebo (Pre-randomization)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w up to Week 16 (total of 4 infusions). Participants also received MTX capsules, orally at a stable dose (10, 15, 17.5, or 20 mg/week but no maximum dose was set) weekly, up to Week 16. Participants with a response were randomized to receive TCZ and matching MTX placebo in the second part of the study. Response was defined as participants having DAS28 score <=3.2.
247526|NCT01399697|E2|Reported Event|TCZ + MTX (Pre-randomization)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w up to Week 16 (total of 4 infusions). Participants also received MTX capsules, orally at a stable dose (10, 15, 17.5, or 20 mg/week but no maximum dose was set) weekly, up to Week 16. Participants with a response were randomized to receive TCZ and MTX in the second part of the study. Response was defined as participants having DAS28 score less than or equal to (<=)3.2.
247527|NCT01399697|E1|Reported Event|TCZ + MTX (Not Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules orally, at a stable dose (10, 15, 17.5, or 20 mg, no maximum dose was defined) weekly from Week 1 through 16.
247528|NCT01399619|B3|Baseline|Total|Total of all reporting groups
247529|NCT01399619|B2|Baseline|Faldaprevir 240mg -T|patient to receive Faldaprevir 240 mg once a day for 12 or 24 weeks and PegIFN/RBV for 24 or 48 weeks + patients who received Faldaprevir 240 mg and discontinued prior to week 12.
247530|NCT01399619|B1|Baseline|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247531|NCT01399619|P4|Participant Flow|Faldaprevir 240 mg -NR (Prior to Re-randomization at Week 12)|Patients initially assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at WK 12.
247532|NCT01399619|P3|Participant Flow|Faldaprevir 240mg-24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247533|NCT01399619|P2|Participant Flow|Faldaprevir 240mg -12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247534|NCT01399619|P1|Participant Flow|Faldaprevir 120mg -24W|Faldaprevir (BI 201335) 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247535|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
247536|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
247537|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247538|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247539|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247540|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
247541|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
247542|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247543|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247544|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247545|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
247546|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
247547|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247548|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247549|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247550|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
247551|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
247552|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247553|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247554|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247555|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
247556|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
247557|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247558|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247559|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247560|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
247561|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
247562|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247563|NCT01399619|O2|Outcome|Faldaprevir 240mg -12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247564|NCT01399619|O1|Outcome|Faldaprevir 120mg -24W|Faldaprevir 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247565|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
247566|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
247567|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247568|NCT01399619|O2|Outcome|Faldaprevir 240mg -12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247569|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247570|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
247571|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
247572|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247573|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247574|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247575|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
247576|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
247577|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247578|NCT01399619|O2|Outcome|Faldaprevir 240mg -12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247579|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247580|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
247581|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
247582|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247583|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247584|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247585|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
247586|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
247587|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue BI 201335 to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247588|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247589|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247590|NCT01399619|E4|Reported Event|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
247591|NCT01399619|E3|Reported Event|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247592|NCT01399619|E2|Reported Event|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247593|NCT01399619|E1|Reported Event|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
247594|NCT01399593|B3|Baseline|Total|Total of all reporting groups
247595|NCT01399593|B2|Baseline|Standard of Care (SOC)|Patients in the standard of care (SOC) treatment group received prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg.
247596|NCT01399593|B1|Baseline|Eculizumab|"Patients in the eculizumab treatment group were to receive eculizumab for 9 weeks according to the following dosing regimen:~Eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9). All doses of eculizumab were administered intravenously."
247597|NCT01399593|P2|Participant Flow|Standard of Care|Patients received standard of care (SOC) prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg.
247598|NCT01399593|P1|Participant Flow|Eculizumab|Patients were to receive eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9).
247599|NCT01399593|O2|Outcome|Standard of Care|Patients in the standard of care (SOC) treatment group received prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg.
247600|NCT01399593|O1|Outcome|Eculizumab|Patients were to receive eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9). All doses of eculizumab were administered intravenously.
247601|NCT01399593|E2|Reported Event|Standard of Care|Patients received standard of care (SOC) prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg.
247602|NCT01399593|E1|Reported Event|Eculizumab|Patients were to receive eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9). All doses of eculizumab were administered intravenously.
247603|NCT01399268|B3|Baseline|Total|Total of all reporting groups
247604|NCT01399268|B2|Baseline|Control|"Saline IV Q8hr x3~Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times"
247605|NCT01399268|B1|Baseline|Steroid|"Hydrocortisone 100 mg IV Q 8hrs x3~Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times"
247750|NCT01398514|E2|Reported Event|Placebo|Matched pill placebo
247606|NCT01399268|P2|Participant Flow|Control|"Saline IV Q8hr x3~Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times"
247607|NCT01399268|P1|Participant Flow|Steroid|"Hydrocortisone 100 mg IV Q 8hrs x3~Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times"
247608|NCT01399268|O2|Outcome|Control|"Saline IV Q8hr x3~Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times"
247609|NCT01399268|O1|Outcome|Steroid|"Hydrocortisone 100 mg IV Q 8hrs x3~Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times"
247610|NCT01399268|O2|Outcome|Control|"Saline IV Q8hr x3~Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times"
247611|NCT01399268|O1|Outcome|Steroid|"Hydrocortisone 100 mg IV Q 8hrs x3~Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times"
247612|NCT01399268|O2|Outcome|Control|"Saline IV Q8hr x3~Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times"
247613|NCT01399268|O1|Outcome|Steroid|"Hydrocortisone 100 mg IV Q 8hrs x3~Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times"
247614|NCT01399268|O2|Outcome|Control|"Saline IV Q8hr x3~Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times"
247615|NCT01399268|O1|Outcome|Steroid|"Hydrocortisone 100 mg IV Q 8hrs x3~Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times"
247616|NCT01399268|O2|Outcome|Control|"Saline IV Q8hr x3~Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times"
247617|NCT01399268|O1|Outcome|Steroid|"Hydrocortisone 100 mg IV Q 8hrs x3~Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times"
247618|NCT01399268|O2|Outcome|Control|"Saline IV Q8hr x3~Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times"
247619|NCT01399268|O1|Outcome|Steroid|"Hydrocortisone 100 mg IV Q 8hrs x3~Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times"
247620|NCT01399268|O2|Outcome|Control|"Saline IV Q8hr x3~Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times"
247621|NCT01399268|O1|Outcome|Steroid|"Hydrocortisone 100 mg IV Q 8hrs x3~Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times"
247622|NCT01399268|E2|Reported Event|Control|"Saline IV Q8hr x3~Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times"
247623|NCT01399268|E1|Reported Event|Steroid|"Hydrocortisone 100 mg IV Q 8hrs x3~Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times"
247624|NCT01399229|B1|Baseline|Pregnant|The study focused on recruiting laboring preterm patients, nonlaboring preterm patients, and nonlaboring term patients.
247625|NCT01399229|P3|Participant Flow|Pregnant, Term, Non Labor|Pregnant term women independently determined to be in labor.
247626|NCT01399229|P2|Participant Flow|Pregnant, Preterm, Non Labor|Pregnant preterm women independently determined to not be in labor.
247627|NCT01399229|P1|Participant Flow|Pregnant, Preterm, In Labor|Pregnant preterm women independently determined to be in labor.
247628|NCT01399229|O1|Outcome|Pregnant Patents With Uterine Contractions|Patient contractions were monitored with both SureCALL® Labor Monitor® and Tocodynamometer. The times of peak contractions recorded by both devices were compared, and the time differences between contractions were assessed.
247629|NCT01399229|E1|Reported Event|Pregnant|
247630|NCT01399190|B1|Baseline|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
247631|NCT01399190|P1|Participant Flow|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
247632|NCT01399190|O1|Outcome|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
247633|NCT01399190|O1|Outcome|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
247634|NCT01399190|O1|Outcome|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
247635|NCT01399190|E1|Reported Event|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
247636|NCT01399125|B3|Baseline|Total|Total of all reporting groups
247637|NCT01399125|B2|Baseline|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
247638|NCT01399125|B1|Baseline|Rivastigmine Patch|Once-daily target patch size 10 cm²
247639|NCT01399125|P2|Participant Flow|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
247640|NCT01399125|P1|Participant Flow|Rivastigmine Patch|Once-daily target patch size 10 cm²
247641|NCT01399125|O2|Outcome|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
247642|NCT01399125|O1|Outcome|Rivastigmine Patch|Once-daily target patch size 10 cm²
247643|NCT01399125|O2|Outcome|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
247644|NCT01399125|O1|Outcome|Rivastigmine Patch|Once-daily target patch size 10 cm²
247645|NCT01399125|O2|Outcome|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
247646|NCT01399125|O1|Outcome|Rivastigmine Patch|Once-daily target patch size 10 cm²
247647|NCT01399125|O2|Outcome|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
247648|NCT01399125|O1|Outcome|Rivastigmine Patch|Once-daily target patch size 10 cm²
247649|NCT01399125|O2|Outcome|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
247650|NCT01399125|O1|Outcome|Rivastigmine Patch|Once-daily target patch size 10 cm²
247651|NCT01399125|E2|Reported Event|Rivastigmine Capsule|Twice-daily target dose of 6 mg oral capsule
247652|NCT01399125|E1|Reported Event|Rivastigmine Patch|Once-daily target patch size 10 cm²
247653|NCT01399099|B1|Baseline|All Study Participants|Half of the abdomnioplasty incision was treated with the embrace device. Half of the abdomnioplasty incision was treated according to the investigator’s standard of care. Participant served as his own control.
247654|NCT01399099|P1|Participant Flow|All Study Participants|Half of the abdomnioplasty incision was treated with the embrace device. Half of the abdomnioplasty incision was treated according to the investigator’s standard of care. Participant served as his own control.
247655|NCT01399099|O2|Outcome|Control Side|Half of the abdomnioplasty incision was treated according to the Investigator’s standard of care. Participant served as his/her own control.
247656|NCT01399099|O1|Outcome|Treated Side|Half of the abdomnioplasty incision was treated with the embrace device.
247657|NCT01399099|E1|Reported Event|All Study Participants|Half of the abdomnioplasty incision was treated with the embrace device. Half of the abdomnioplasty incision was treated according to the investigator’s standard of care. Participant served as his own control.
247658|NCT01399047|B3|Baseline|Total|Total of all reporting groups
247659|NCT01399047|B2|Baseline|Group B: Placebo to Mycophenolate Crossover|Subjects received one treatment period (8 weeks) of placebo, then, after a 4-week washout, received one treatment period (8 weeks) of mycophenolate, in a blinded manner.
247660|NCT01399047|B1|Baseline|Group A: Mycophenolate to Placebo Crossover|Subjects received one treatment period (8 weeks) of mycophenolate, then, after a 4-week washout, received one treatment period (8 weeks) of placebo, in a blinded manner.
247661|NCT01399047|P2|Participant Flow|Group B: Placebo to Mycophenolate Crossover|Subjects received one treatment period (8 weeks) of placebo, then, after a 4-week washout, received one treatment period (8 weeks) of mycophenolate, in a blinded manner.
247662|NCT01399047|P1|Participant Flow|Group A: Mycophenolate to Placebo Crossover|Subjects received one treatment period (8 weeks) of mycophenolate, then, after a 4-week washout, received one treatment period (8 weeks) of placebo, in a blinded manner.
247663|NCT01399047|O2|Outcome|Placebo|Includes data from all subjects while on placebo, regardless of treatment order.
247664|NCT01399047|O1|Outcome|Mycophenolate|Includes data from all subjects while on mycophenolate, regardless of treatment order.
247665|NCT01399047|E2|Reported Event|Placebo|Includes data from all subjects while on placebo, regardless of order.
247666|NCT01399047|E1|Reported Event|Mycophenolate|Includes data from all subjects while on mycophenolate, regardless of order.
247667|NCT01399008|B4|Baseline|Total|Total of all reporting groups
247668|NCT01399008|B3|Baseline|Placebo|Placebo plus Allopurinol 300 mg
247669|NCT01399008|B2|Baseline|Arhalofenate 600 mg|Arhalofenate 600 mg plus allopurinol 300 mg
247670|NCT01399008|B1|Baseline|Arhalofenate 400 mg|Arhalofenate 400 mg plus allopurinol 300 mg
247671|NCT01399008|P3|Participant Flow|Placebo|Placebo plus Allopurinol 300 mg
247672|NCT01399008|P2|Participant Flow|Arhalofenate 600 mg|Arhalofenate 600 mg plus allopurinol 300 mg
247673|NCT01399008|P1|Participant Flow|Arhalofenate 400 mg|Arhalofenate 400 mg plus allopurinol 300 mg
247674|NCT01399008|O3|Outcome|Placebo|Placebo plus Allopurinol 300 mg
247675|NCT01399008|O2|Outcome|Arhalofenate 600 mg|Arhalofenate 600 mg plus allopurinol 300 mg
247676|NCT01399008|O1|Outcome|Arhalofenate 400 mg|Arhalofenate 400 mg plus allopurinol 300 mg
247677|NCT01399008|E3|Reported Event|Placebo Plus Allopurinol 300 mg|Placebo plus allopurinol 300 mg (Safety Population)
247678|NCT01399008|E2|Reported Event|Arhalofenate 600 mg Plus Allopurinol 300 mg|Arhalofenate 600 mg plus allopurinol 300 mg (Safety Population)
247679|NCT01399008|E1|Reported Event|Arhalofenate 400 mg Plus Allopurinol 300 mg|Arhalofenate 400 mg plus allopurinol 300 mg (Safety Population)
247680|NCT01398982|B3|Baseline|Total|Total of all reporting groups
247681|NCT01398982|B2|Baseline|Bupivacaine (Study Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
247682|NCT01398982|B1|Baseline|Isotonic Saline (Control Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
247683|NCT01398982|P2|Participant Flow|Bupivacaine (Study Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
247684|NCT01398982|P1|Participant Flow|Isotonic Saline (Control Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
247685|NCT01398982|O2|Outcome|Bupivacaine (Study Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
247686|NCT01398982|O1|Outcome|Isotonic Saline (Control Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
247687|NCT01398982|E2|Reported Event|Bupivacaine (Study Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
247688|NCT01398982|E1|Reported Event|Isotonic Saline (Control Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
247689|NCT01398956|B1|Baseline|Levetiracetam|Levetiracetam dose was be adjusted at the investigator’s discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study
247690|NCT01398956|P1|Participant Flow|Levetiracetam|Levetiracetam dose was be adjusted at the investigator’s discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study
247691|NCT01398956|O1|Outcome|Levetiracetam (SS)|Levetiracetam dose was be adjusted at the investigator’s discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study
247692|NCT01398956|O1|Outcome|Levetiracetam (FAS)|Levetiracetam dose was be adjusted at the investigator’s discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study
247693|NCT01398956|O1|Outcome|Levetiracetam (SS)|Levetiracetam dose was be adjusted at the investigator’s discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study
247694|NCT01398956|E1|Reported Event|Levetiracetam (SS)|Levetiracetam dose was be adjusted at the investigator’s discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study
247695|NCT01398943|B3|Baseline|Total|Total of all reporting groups
247696|NCT01398943|B2|Baseline|All Controls|Healthy age- and sex- matched controls
247697|NCT01398943|B1|Baseline|All COPD Patients|Patients with COPD
247698|NCT01398943|P4|Participant Flow|Controls: Placebo First, Then AOC|"Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) was assessed at baseline and 2 hours following ingestion of microcrystalline cellulose capsules as a placebo.~After a minimum of 2 days washout, subjects returned to perform all measures again but were given an oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid."
247699|NCT01398943|P3|Participant Flow|Controls: AOC First, Then Placebo|"Healthy age- and sex- matched controls~Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) were assessed at baseline and 2 hours following ingestion of an oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.~After a minimum of 2 days washout, subjects returned to perform all measures again but were given microcrystalline cellulose capsules as a placebo."
247700|NCT01398943|P2|Participant Flow|COPD: Placebo First, Then AOC|"Patients with COPD~Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) was assessed at baseline and 2 hours following ingestion of microcrystalline cellulose capsules as a placebo.~After a minimum of 2 days washout, patients returned to perform all measures again but were given an oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid."
247701|NCT01398943|P1|Participant Flow|COPD: AOC First, Then Placebo|"Patients with COPD~Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) were assessed at baseline and 2 hours following ingestion of an oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.~After a minimum of 2 days washout, patients returned to perform all measures again but were given microcrystalline cellulose capsules as a placebo."
247702|NCT01398943|O2|Outcome|All Controls|"Healthy age- and sex- matched controls~Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) will be assessed at baseline and 2 hours following ingestion of a single oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid"
247703|NCT01398943|O1|Outcome|All COPD Patients|"Patients with COPD~Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) will be assessed at baseline and 2 hours following ingestion of a single oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid"
247704|NCT01398943|O2|Outcome|All Controls|Healthy age- and sex- matched controls
247706|NCT01398943|E2|Reported Event|Controls|"Healthy age- and sex- matched controls~Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) will be assessed at baseline and 2 hours following ingestion of a single oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid"
247707|NCT01398943|E1|Reported Event|COPD Patients|"Patients with COPD~Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) will be assessed at baseline and 2 hours following ingestion of a single oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid"
247708|NCT01398852|B1|Baseline|CXL Treatment|All eyes to be treated with riboflavin and UV light
247709|NCT01398852|P1|Participant Flow|CXL Treatment|All eyes to be treated with riboflavin and UV light
247710|NCT01398852|O1|Outcome|CXL Treatment|All eyes to be treated with riboflavin and UV light
247711|NCT01398852|E1|Reported Event|CXL Treatment|All eyes to be treated with riboflavin and UV light
247712|NCT01398839|B3|Baseline|Total|Total of all reporting groups
247713|NCT01398839|B2|Baseline|Sham Control|Riboflavin : Both treatment and sham groups will receive riboflavin
247714|NCT01398839|B1|Baseline|CXL Treatment|"VEGA UV-A Illumination System : Only subjects assigned to the treatment group will receive treatment with the UV Light~Riboflavin : Both treatment and sham groups will receive riboflavin"
247715|NCT01398839|P2|Participant Flow|Sham Control|Riboflavin : Both treatment and sham groups will receive riboflavin
247716|NCT01398839|P1|Participant Flow|CXL Treatment|"VEGA UV-A Illumination System : Only subjects assigned to the treatment group will receive treatment with the UV Light~Riboflavin : Both treatment and sham groups will receive riboflavin"
247717|NCT01398839|O2|Outcome|Sham Control|Riboflavin : Both treatment and sham groups will receive riboflavin
247718|NCT01398839|O1|Outcome|CXL Treatment|"VEGA UV-A Illumination System : Only subjects assigned to the treatment group will receive treatment with the UV Light~Riboflavin : Both treatment and sham groups will receive riboflavin"
247719|NCT01398839|E2|Reported Event|Sham Control|Riboflavin : Both treatment and sham groups will receive riboflavin
247720|NCT01398839|E1|Reported Event|CXL Treatment|"VEGA UV-A Illumination System : Only subjects assigned to the treatment group will receive treatment with the UV Light~Riboflavin : Both treatment and sham groups will receive riboflavin"
247721|NCT01398787|B1|Baseline|AIR OPTIX® COLORS/FRESHLOOK® COLORBLENDS|AIR OPTIX® COLORS and FRESHLOOK® COLORBLENDS, contralateral wear
247722|NCT01398787|P1|Participant Flow|AIR OPTIX® COLORS/FRESHLOOK® COLORBLENDS|AIR OPTIX® COLORS and FRESHLOOK® COLORBLENDS, contralateral wear
247723|NCT01398787|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
247724|NCT01398787|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes
247725|NCT01398787|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
247726|NCT01398787|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes
247727|NCT01398787|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
247728|NCT01398787|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes
247729|NCT01398787|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
247730|NCT01398787|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes
247731|NCT01398787|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
247732|NCT01398787|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes
247733|NCT01398787|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
247734|NCT01398787|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes
247735|NCT01398787|E2|Reported Event|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye, up to 10 minutes each
247736|NCT01398787|E1|Reported Event|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 4 colors (gray, blue, green, pure hazel) worn in one eye, up to 10 minutes each
247737|NCT01398514|B3|Baseline|Total|Total of all reporting groups
247738|NCT01398514|B2|Baseline|Placebo|Matched pill placebo
247739|NCT01398514|B1|Baseline|Active Medication|Escitalopram 10mg/day
247740|NCT01398514|P2|Participant Flow|Placebo|Matched pill placebo
247741|NCT01398514|P1|Participant Flow|Active Medication|Escitalopram 10mg/day
247742|NCT01398514|O4|Outcome|Placebo CS+|
247743|NCT01398514|O3|Outcome|Placebo CS-|
247744|NCT01398514|O2|Outcome|Active Medication CS+|Matched pill placebo
247745|NCT01398514|O1|Outcome|Active Medication CS-|Escitalopram 10mg/day
247746|NCT01398514|O4|Outcome|Placebo CS+|
247747|NCT01398514|O3|Outcome|Placebo CS-|
247748|NCT01398514|O2|Outcome|Active Medication CS+|Matched pill placebo
247749|NCT01398514|O1|Outcome|Active Medication CS-|Escitalopram 10mg/day
247752|NCT01398475|B1|Baseline|Entire Study Population|"Includes groups randomized to receive any of the following study drugs as the first intervention.~LY3009104 Reference Formulation (RF): 8-milligram (mg) dose of LY3009104 RF (two 4-mg phosphate salt capsules) administered once in a fasted state.~LY3009104 Test Formulation 1 (TF1), 20 micrometers (mcm): 8-mg dose of LY3009104 TF1 [one 8-mg tablet, free base formulation, target active pharmaceutical ingredient (API) particle size of 20 mcm] administered once in a fasted state.~LY3009104 Test Formulation 2 (TF2), 50 mcm, fasted: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state.~LY3009104 TF2, 50 mcm, fed: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal."
247753|NCT01398475|P4|Participant Flow|LY 50-mcm Fed, LY 50-mcm Fasted, LY RF, LY 20-mcm|"First intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal.~Second intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state.~Third intervention: 8-mg dose of LY3009104 RF (two 4-mg phosphate salt capsules) administered once in a fasted state.~Fourth Intervention: 8-mg dose of LY3009104 TF1 (one 8-mg tablet, free base formulation, target API particle size of 20 mcm) administered once in a fasted state.~There was a washout period of 5 to 7 days between doses of study drug."
247754|NCT01398475|P3|Participant Flow|LY 50-mcm Fasted, LY 20-mcm, LY 50-mcm Fed, LY RF|"First intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state.~Second intervention: 8-mg dose of LY3009104 TF1 (one 8-mg tablet, free base formulation, target API particle size of 20 mcm) administered once in a fasted state.~Third intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal.~Fourth intervention: 8-mg dose of LY3009104 RF (two 4-mg phosphate salt capsules) administered once in a fasted state.~There was a washout period of 5 to 7 days between doses of study drug."
247755|NCT01398475|P2|Participant Flow|LY 20-mcm, LY RF, LY 50-mcm Fasted, LY 50-mcm Fed|"First intervention: 8-mg dose of LY3009104 TF1 (one 8-mg tablet, free base formulation, target API particle size of 20 mcm) administered once in a fasted state.~Second intervention: 8-mg dose of LY3009104 RF (two 4-mg phosphate salt capsules) administered once in a fasted state.~Third intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state.~Fourth intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal.~There was a washout period of 5 to 7 days between doses of study drug."
247756|NCT01398475|P1|Participant Flow|LY3009104 (LY) RF, LY 50-mcm Fed, LY 20-mcm, LY 50-mcm Fasted|"First intervention: 8-milligram (mg) dose of LY3009104 reference formulation (RF, two 4-mg phosphate salt capsules) administered once in a fasted state.~Second intervention: 8-mg dose of LY3009104 test formulation 2 [TF2, one 8-mg tablet, free base formulation, target active pharmaceutical ingredient (API) particle size of 50 micrometers (mcm)] administered once with a high-fat, high calorie meal.~Third intervention: 8-mg dose of LY3009104 test formulation 1 (TF1, one 8-mg tablet, free base formulation, target API particle size of 20 mcm) administered once in a fasted state.~Fourth intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state.~There was a washout period of 5 to 7 days between doses of study drug."
247757|NCT01398475|O4|Outcome|LY3009104 Test Formulation 2 (50-mcm, Fasted)|8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state in Period 1, 2, 3, or 4.
247758|NCT01398475|O3|Outcome|LY3009104 Test Formulation 2 (50-mcm, Fed)|8-mg dose of LY3009104 test formulation 2 (TF2, one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal in Period 1, 2, 3, or 4.
247759|NCT01398475|O2|Outcome|LY3009104 Test Formulation 1 (20-mcm)|8-mg dose of LY3009104 test formulation 1 [TF1, one 8-mg tablet, free base formulation, target active pharmaceutical ingredient (API) particle size of 20 micrometers (mcm)] administered once in a fasted state in Period 1, 2, 3, or 4.
247760|NCT01398475|O1|Outcome|LY3009104 Reference Formulation|8-milligram (mg) dose of LY3009104 reference formulation (RF, two 4-mg phosphate salt capsules) administered once in a fasted state in Period 1, 2, 3, or 4.
247761|NCT01398475|O4|Outcome|LY3009104 Test Formulation 2 (50-mcm, Fasted)|8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state in Period 1, 2, 3, or 4.
247762|NCT01398475|O3|Outcome|LY3009104 Test Formulation 2 (50-mcm, Fed)|8-mg dose of LY3009104 test formulation 2 (TF2, one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal in Period 1, 2, 3, or 4.
247763|NCT01398475|O2|Outcome|LY3009104 Test Formulation 1 (20-mcm)|8-mg dose of LY3009104 test formulation 1 [TF1, one 8-mg tablet, free base formulation, target active pharmaceutical ingredient (API) particle size of 20 micrometers (mcm)] administered once in a fasted state in Period 1, 2, 3, or 4.
247764|NCT01398475|O1|Outcome|LY3009104 Reference Formulation|8-milligram (mg) dose of LY3009104 reference formulation (RF, two 4-mg phosphate salt capsules) administered once in a fasted state in Period 1, 2, 3, or 4.
247765|NCT01398475|O4|Outcome|LY3009104 Test Formulation 2 (50-mcm, Fasted)|8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state in Period 1, 2, 3, or 4.
247766|NCT01398475|O3|Outcome|LY3009104 Test Formulation 2 (50-mcm, Fed)|8-mg dose of LY3009104 test formulation 2 (TF2, one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal in Period 1, 2, 3, or 4.
247767|NCT01398475|O2|Outcome|LY3009104 Test Formulation 1 (20-mcm)|8-mg dose of LY3009104 test formulation 1 [TF1, one 8-mg tablet, free base formulation, target active pharmaceutical ingredient (API) particle size of 20 micrometers (mcm)] administered once in a fasted state in Period 1, 2, 3, or 4.
247768|NCT01398475|O1|Outcome|LY3009104 Reference Formulation|8-milligram (mg) dose of LY3009104 reference formulation (RF, two 4-mg phosphate salt capsules) administered once in a fasted state in Period 1, 2, 3, or 4.
247769|NCT01398475|E4|Reported Event|LY3009104 Test Formulation 2 (50-mcm, Fasted)|8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state in Period 1, 2, 3, or 4.
247770|NCT01398475|E3|Reported Event|LY3009104 Test Formulation 1 (20-mcm)|8-mg dose of LY3009104 test formulation 1 (TF1, one 8-mg tablet, free base formulation, target API particle size of 20 mcm) administered once in a fasted state in Period 1, 2, 3, or 4.
247771|NCT01398475|E2|Reported Event|LY3009104 Test Formulation 2 (50-mcm, Fed)|8-mg dose of LY3009104 test formulation 2 [TF2, one 8-mg tablet, free base formulation, target active pharmaceutical ingredient (API) particle size of 50 micrometer (mcm)] administered once with a high-fat, high calorie meal in Period 1, 2, 3, or 4.
247772|NCT01398475|E1|Reported Event|LY3009104 Reference Formulation|8-milligram (mg) dose of LY3009104 reference formulation (RF, two 4-mg phosphate salt capsules) administered once in a fasted state in Period 1, 2, 3, or 4.
247773|NCT01398410|B3|Baseline|Total|Total of all reporting groups
247774|NCT01398410|B2|Baseline|Rabeprazole 10 mg|Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
247775|NCT01398410|B1|Baseline|Rabeprazole 5 mg|Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
247776|NCT01398410|P2|Participant Flow|Rabeprazole 10 mg|Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
247777|NCT01398410|P1|Participant Flow|Rabeprazole 5 mg|Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
247778|NCT01398410|O2|Outcome|Rabeprazole 10 mg|Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
247779|NCT01398410|O1|Outcome|Rabeprazole 5 mg|Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
247780|NCT01398410|O2|Outcome|Rabeprazole 10 mg|Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
247781|NCT01398410|O1|Outcome|Rabeprazole 5 mg|Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
247782|NCT01398410|E2|Reported Event|Rabeprazole10 mg|Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
247783|NCT01398410|E1|Reported Event|Rabeprazole 5 mg|Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
247784|NCT01398358|B4|Baseline|Total|Total of all reporting groups
247785|NCT01398358|B3|Baseline|POPS + Incredible Years Series (IYS)|"Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention. In the classroom, children also receive a series of lessons about emotional and behavioral self-regulation delivered by a trained mental health specialist. The parents also are invited to classes about child behavioral and emotional self-regulation delivered by a mental health specialist.~Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge an"
247786|NCT01398358|B2|Baseline|Parents of Preschoolers Series (POPS)|"Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention.~Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge and self-efficacy.~The POPS-Child Intervention uses children's stories with embedded healthy nutrition themes. Five lessons (6 books) are delivered over 12 weeks. Activities include classroom cooking experiences, games/activities associated with the story's nutrition themes, and goal"
247787|NCT01398358|B1|Baseline|Usual Head Start Exposure|Children will attend their usual Head Start classroom and receive the usual educational interventions provided in that classroom.
247788|NCT01398358|P3|Participant Flow|POPS + Incredible Years Series (IYS)|"Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention. In the classroom, children also receive a series of lessons about emotional and behavioral self-regulation delivered by a trained mental health specialist. The parents also are invited to classes about child behavioral and emotional self-regulation delivered by a mental health specialist~Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge an"
247789|NCT01398358|P2|Participant Flow|Parents of Preschoolers Series (POPS)|"Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention.~Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge and self-efficacy.~The POPS-Child Intervention uses children's stories with embedded healthy nutrition themes. Five lessons (6 books) are delivered over 12 weeks. Activities include classroom cooking experiences, games/activities associated with the story's nutrition themes, and goal"
247790|NCT01398358|P1|Participant Flow|Usual Head Start Exposure|Children will attend their usual Head Start classroom and receive the usual educational interventions provided in that classroom.
247808|NCT01398176|E1|Reported Event|3 Ounces of Mushrooms|3 ounces of mushrooms consumed daily for 4 weeks
247809|NCT01397890|B3|Baseline|Total|Total of all reporting groups
265244|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
247791|NCT01398358|O3|Outcome|POPS + Incredible Years Series (IYS)|"Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention. In the classroom, children also receive a series of lessons about emotional and behavioral self-regulation delivered by a trained mental health specialist. The parents also are invited to classes about child behavioral and emotional self-regulation delivered by a mental health specialist.~Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge an"
247792|NCT01398358|O2|Outcome|Parents of Preschoolers Series (POPS)|"Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention.~Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge and self-efficacy.~The POPS-Child Intervention uses children's stories with embedded healthy nutrition themes. Five lessons (6 books) are delivered over 12 weeks. Activities include classroom cooking experiences, games/activities associated with the story's nutrition themes, and goal"
247793|NCT01398358|O1|Outcome|Usual Head Start Exposure|Children will attend their usual Head Start classroom and receive the usual educational interventions provided in that classroom.
247794|NCT01398358|O3|Outcome|POPS + Incredible Years Series (IYS)|"Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention. In the classroom, children also receive a series of lessons about emotional and behavioral self-regulation delivered by a trained mental health specialist. The parents also are invited to classes about child behavioral and emotional self-regulation delivered by a mental health specialist.~Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge an"
247795|NCT01398358|O2|Outcome|Parents of Preschoolers Series (POPS)|"Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention.~Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge and self-efficacy.~The POPS-Child Intervention uses children's stories with embedded healthy nutrition themes. Five lessons (6 books) are delivered over 12 weeks. Activities include classroom cooking experiences, games/activities associated with the story's nutrition themes, and goal"
247796|NCT01398358|O1|Outcome|Usual Head Start Exposure|Children will attend their usual Head Start classroom and receive the usual educational interventions provided in that classroom.
247797|NCT01398358|E3|Reported Event|POPS + Incredible Years Series (IYS)|"Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention. In the classroom, children also receive a series of lessons about emotional and behavioral self-regulation delivered by a trained mental health specialist. The parents also are invited to classes about child behavioral and emotional self-regulation delivered by a mental health specialist.~Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge an"
247798|NCT01398358|E2|Reported Event|Parents of Preschoolers Series (POPS)|"Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention.~Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge and self-efficacy.~The POPS-Child Intervention uses children's stories with embedded healthy nutrition themes. Five lessons (6 books) are delivered over 12 weeks. Activities include classroom cooking experiences, games/activities associated with the story's nutrition themes, and goal"
247799|NCT01398358|E1|Reported Event|Usual Head Start Exposure|Children will attend their usual Head Start classroom and receive the usual educational interventions provided in that classroom.
247800|NCT01398176|B3|Baseline|Total|Total of all reporting groups
247801|NCT01398176|B2|Baseline|6 Ounces of Mushrooms|6 ounces of mushrooms consumed daily for 4 weeks
247802|NCT01398176|B1|Baseline|3 Ounces of Mushrooms|3 ounces of mushrooms consumed daily for 4 weeks
247803|NCT01398176|P2|Participant Flow|6 Ounces of Mushrooms|6 ounces of mushrooms consumed daily for 4 weeks
247804|NCT01398176|P1|Participant Flow|3 Ounces of Mushrooms|3 ounces of mushrooms consumed daily for 4 weeks
247805|NCT01398176|O2|Outcome|6 Ounces of Mushrooms|6 ounces of mushrooms consumed daily for 4 weeks
247806|NCT01398176|O1|Outcome|3 Ounces of Mushrooms|3 ounces of mushrooms consumed daily for 4 weeks
247811|NCT01397890|B1|Baseline|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247812|NCT01397890|P2|Participant Flow|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247813|NCT01397890|P1|Participant Flow|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247814|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247815|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247816|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247817|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247818|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247819|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247820|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247821|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247822|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247823|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247824|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247825|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247826|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247827|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247828|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247829|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247830|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247831|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247832|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247833|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247834|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247835|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247836|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247837|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247838|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247839|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247840|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247841|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247842|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247843|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247844|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247845|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247846|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247847|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247848|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247849|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247850|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247851|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247852|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247853|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247854|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247855|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247856|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247857|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247858|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247859|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247860|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247861|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247862|NCT01397890|E2|Reported Event|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
247863|NCT01397890|E1|Reported Event|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
247864|NCT01397851|B3|Baseline|Total|Total of all reporting groups
247865|NCT01397851|B2|Baseline|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
247866|NCT01397851|B1|Baseline|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net~Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
247867|NCT01397851|P2|Participant Flow|Treatment|
247868|NCT01397851|P1|Participant Flow|Control|
247869|NCT01397851|O2|Outcome|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
247870|NCT01397851|O1|Outcome|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net~Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
247871|NCT01397851|O2|Outcome|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
247872|NCT01397851|O1|Outcome|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net~Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
247873|NCT01397851|O2|Outcome|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
247874|NCT01397851|O1|Outcome|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net~Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
247875|NCT01397851|O2|Outcome|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
247876|NCT01397851|O1|Outcome|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net~Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
247877|NCT01397851|E2|Reported Event|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
247878|NCT01397851|E1|Reported Event|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net~Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
247879|NCT01397825|B5|Baseline|Total|Total of all reporting groups
247880|NCT01397825|B4|Baseline|Dose Escalation, Alisertib 50 mg|Alisertib 50 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247881|NCT01397825|B3|Baseline|Dose Escalation, Alisertib 40 mg|Alisertib 40 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247882|NCT01397825|B2|Baseline|Dose Escalation, Alisertib 30 mg|Alisertib 30 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1, plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247883|NCT01397825|B1|Baseline|Safety Lead-in|Alisertib 50 mg, enteric coated tablets (ECT), orally, twice daily (BID), on Days 1 to 7 followed by a 14-day rest period in 21-day cycles plus rituximab 375 mg/m^2, intravenous (IV), infusion on Day 1 of each 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247884|NCT01397825|P5|Participant Flow|Phase 2: Alisertib|Phase 2: Alisertib (MLN8237) at the Recommended Phase 2 Dose, ECT orally twice/day on Days 1-7 & rituximab as an IV infusion on Day 1 & vincristine IV on Days 1 & 8 in a 21 Day cycle for up to 8 cycles was planned but not conducted.
248035|NCT01397617|P2|Participant Flow|NobelActive External|"NobelActive External implant~NobelActive External implant"
248036|NCT01397617|P1|Participant Flow|NobelActive Internal|"NobelActive Internal implant~NobelActive Internal implant"
247885|NCT01397825|P4|Participant Flow|Dose Escalation, Alisertib 50 mg|Alisertib 50 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247886|NCT01397825|P3|Participant Flow|Dose Escalation, Alisertib 40 mg|Alisertib 40 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247887|NCT01397825|P2|Participant Flow|Dose Escalation, Alisertib 30 mg|Alisertib 30 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1, plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247888|NCT01397825|P1|Participant Flow|Safety Lead-in|Alisertib 50 mg, enteric coated tablets (ECT), orally, twice daily (BID), on Days 1 to 7 followed by a 14-day rest period in 21-day cycles plus rituximab 375 mg/m^2, intravenous (IV), infusion on Day 1 of each 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247889|NCT01397825|O3|Outcome|Dose Escalation, Alisertib 50 mg|Alisertib 50 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247890|NCT01397825|O2|Outcome|Dose Escalation, Alisertib 40 mg|Alisertib 40 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247891|NCT01397825|O1|Outcome|Dose Escalation, Alisertib 30 mg|Alisertib 30 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1, plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247892|NCT01397825|O3|Outcome|Dose Escalation, Alisertib 50 mg|Alisertib 50 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247893|NCT01397825|O2|Outcome|Dose Escalation, Alisertib 40 mg|Alisertib 40 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247894|NCT01397825|O1|Outcome|Dose Escalation, Alisertib 30 mg|Alisertib 30 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1, plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247895|NCT01397825|O3|Outcome|Dose Escalation, Alisertib 50 mg|Alisertib 50 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247896|NCT01397825|O2|Outcome|Dose Escalation, Alisertib 40 mg|Alisertib 40 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247897|NCT01397825|O1|Outcome|Dose Escalation, Alisertib 30 mg|Alisertib 30 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1, plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247898|NCT01397825|O3|Outcome|Dose Escalation, Alisertib 50 mg|Alisertib 50 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247914|NCT01397825|O1|Outcome|Phase 2: Alisertib|Phase 2: Alisertib (MLN8237) at the Recommended Phase 2 Dose, ECT orally twice/day on Days 1-7 & rituximab as an IV infusion on Day 1 & vincristine IV on Days 1 & 8 in a 21 Day cycle for up to 8 cycles was planned but not conducted.
248066|NCT01397461|E1|Reported Event|Ozenoxacin 1% Cream|"1% cream~ozenoxacin 1% cream: 1% cream"
247899|NCT01397825|O2|Outcome|Dose Escalation, Alisertib 40 mg|Alisertib 40 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247900|NCT01397825|O1|Outcome|Dose Escalation, Alisertib 30 mg|Alisertib 30 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1, plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247901|NCT01397825|O4|Outcome|Dose Escalation, Alisertib 50 mg|Alisertib 50 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247902|NCT01397825|O3|Outcome|Dose Escalation, Alisertib 40 mg|Alisertib 40 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247903|NCT01397825|O2|Outcome|Dose Escalation, Alisertib 30 mg|Alisertib 30 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1, plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247904|NCT01397825|O1|Outcome|Safety Lead-in|Alisertib 50 mg, enteric coated tablets (ECT), orally, twice daily (BID), on Days 1 to 7 followed by a 14-day rest period in 21-day cycles plus rituximab 375 mg/m^2, intravenous (IV), infusion on Day 1 of each 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247905|NCT01397825|O4|Outcome|Dose Escalation, Alisertib 50 mg|Alisertib 50 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247906|NCT01397825|O3|Outcome|Dose Escalation, Alisertib 40 mg|Alisertib 40 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247907|NCT01397825|O2|Outcome|Dose Escalation, Alisertib 30 mg|Alisertib 30 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1, plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247908|NCT01397825|O1|Outcome|Safety Lead-in|Alisertib 50 mg, enteric coated tablets (ECT), orally, twice daily (BID), on Days 1 to 7 followed by a 14-day rest period in 21-day cycles plus rituximab 375 mg/m^2, intravenous (IV), infusion on Day 1 of each 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247909|NCT01397825|O4|Outcome|Dose Escalation, Alisertib 50 mg|Alisertib 50 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247910|NCT01397825|O3|Outcome|Dose Escalation, Alisertib 40 mg|Alisertib 40 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247911|NCT01397825|O2|Outcome|Dose Escalation, Alisertib 30 mg|Alisertib 30 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1, plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247912|NCT01397825|O1|Outcome|Safety Lead-in|Alisertib 50 mg, enteric coated tablets (ECT), orally, twice daily (BID), on Days 1 to 7 followed by a 14-day rest period in 21-day cycles plus rituximab 375 mg/m^2, intravenous (IV), infusion on Day 1 of each 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247913|NCT01397825|O1|Outcome|Phase 2: Alisertib|Phase 2: Alisertib (MLN8237) at the Recommended Phase 2 Dose, ECT orally twice/day on Days 1-7 & rituximab as an IV infusion on Day 1 & vincristine IV on Days 1 & 8 in a 21 Day cycle for up to 8 cycles was planned but not conducted.
248037|NCT01397617|O3|Outcome|NobelReplace Tapered Groovy|"NobelReplace Tapered Groovy implant~NobelReplace Tapered Groovy implant: Dental implant"
247915|NCT01397825|O1|Outcome|Phase 2: Alisertib|Phase 2: Alisertib (MLN8237) at the Recommended Phase 2 Dose, ECT orally twice/day on Days 1-7 & rituximab as an IV infusion on Day 1 & vincristine IV on Days 1 & 8 in a 21 Day cycle for up to 8 cycles was planned but not conducted.
247916|NCT01397825|O1|Outcome|Phase 2: Alisertib|Phase 2: Alisertib (MLN8237) at the Recommended Phase 2 Dose, ECT orally twice/day on Days 1-7 & rituximab as an IV infusion on Day 1 & vincristine IV on Days 1 & 8 in a 21 Day cycle for up to 8 cycles was planned but not conducted.
247917|NCT01397825|O1|Outcome|Phase 2: Alisertib|Phase 2: Alisertib (MLN8237) at the Recommended Phase 2 Dose, ECT orally twice/day on Days 1-7 & rituximab as an IV infusion on Day 1 & vincristine IV on Days 1 & 8 in a 21 Day cycle for up to 8 cycles was planned but not conducted.
247918|NCT01397825|O1|Outcome|Phase 2: Alisertib|Phase 2: Alisertib (MLN8237) at the Recommended Phase 2 Dose, ECT orally twice/day on Days 1-7 & rituximab as an IV infusion on Day 1 & vincristine IV on Days 1 & 8 in a 21 Day cycle for up to 8 cycles was planned but not conducted.
247919|NCT01397825|O1|Outcome|Phase 2: Alisertib|Phase 2: Alisertib (MLN8237) at the Recommended Phase 2 Dose, ECT orally twice/day on Days 1-7 & rituximab as an IV infusion on Day 1 & vincristine IV on Days 1 & 8 in a 21 Day cycle for up to 8 cycles was planned but not conducted.
247920|NCT01397825|O1|Outcome|Phase 2: Alisertib|Phase 2: Alisertib (MLN8237) at the Recommended Phase 2 Dose, ECT orally twice/day on Days 1-7 & rituximab as an IV infusion on Day 1 & vincristine IV on Days 1 & 8 in a 21 Day cycle for up to 8 cycles was planned but not conducted.
247921|NCT01397825|O4|Outcome|Dose Escalation, Alisertib 50 mg|Alisertib 50 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247922|NCT01397825|O3|Outcome|Dose Escalation, Alisertib 40 mg|Alisertib 40 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247923|NCT01397825|O2|Outcome|Dose Escalation, Alisertib 30 mg|Alisertib 30 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1, plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247924|NCT01397825|O1|Outcome|Safety Lead-in|Alisertib 50 mg, enteric coated tablets (ECT), orally, twice daily (BID), on Days 1 to 7 followed by a 14-day rest period in 21-day cycles plus rituximab 375 mg/m^2, intravenous (IV), infusion on Day 1 of each 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247925|NCT01397825|O1|Outcome|Phase 2: Alisertib|Phase 2: Alisertib (MLN8237) at the Recommended Phase 2 Dose, ECT orally twice/day on Days 1-7 & rituximab as an IV infusion on Day 1 & vincristine IV on Days 1 & 8 in a 21 Day cycle for up to 8 cycles was planned but not conducted.
247926|NCT01397825|O4|Outcome|Dose Escalation, Alisertib 50 mg|Alisertib 50 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247927|NCT01397825|O3|Outcome|Dose Escalation, Alisertib 40 mg|Alisertib 40 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247928|NCT01397825|O2|Outcome|Dose Escalation, Alisertib 30 mg|Alisertib 30 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1, plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247929|NCT01397825|O1|Outcome|Safety Lead-in|Alisertib 50 mg, enteric coated tablets (ECT), orally, twice daily (BID), on Days 1 to 7 followed by a 14-day rest period in 21-day cycles plus rituximab 375 mg/m^2, intravenous (IV), infusion on Day 1 of each 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247930|NCT01397825|O4|Outcome|Dose Escalation, Alisertib 50 mg|Alisertib 50 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247931|NCT01397825|O3|Outcome|Dose Escalation, Alisertib 40 mg|Alisertib 40 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247967|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
248067|NCT01397448|B4|Baseline|Total|Total of all reporting groups
247932|NCT01397825|O2|Outcome|Dose Escalation, Alisertib 30 mg|Alisertib 30 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1, plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247933|NCT01397825|O1|Outcome|Safety Lead-in|Alisertib 50 mg, enteric coated tablets (ECT), orally, twice daily (BID), on Days 1 to 7 followed by a 14-day rest period in 21-day cycles plus rituximab 375 mg/m^2, intravenous (IV), infusion on Day 1 of each 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247934|NCT01397825|O4|Outcome|Dose Escalation, Alisertib 50 mg|Alisertib 50 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247935|NCT01397825|O3|Outcome|Dose Escalation, Alisertib 40 mg|Alisertib 40 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247936|NCT01397825|O2|Outcome|Dose Escalation, Alisertib 30 mg|Alisertib 30 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1, plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247937|NCT01397825|O1|Outcome|Safety Lead-in|Alisertib 50 mg, enteric coated tablets (ECT), orally, twice daily (BID), on Days 1 to 7 followed by a 14-day rest period in 21-day cycles plus rituximab 375 mg/m^2, intravenous (IV), infusion on Day 1 of each 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247938|NCT01397825|O4|Outcome|Dose Escalation, Alisertib 50 mg|Alisertib 50 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247939|NCT01397825|O3|Outcome|Dose Escalation, Alisertib 40 mg|Alisertib 40 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247940|NCT01397825|O2|Outcome|Dose Escalation, Alisertib 30 mg|Alisertib 30 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1, plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247941|NCT01397825|O1|Outcome|Safety Lead-in|Alisertib 50 mg, enteric coated tablets (ECT), orally, twice daily (BID), on Days 1 to 7 followed by a 14-day rest period in 21-day cycles plus rituximab 375 mg/m^2, intravenous (IV), infusion on Day 1 of each 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247942|NCT01397825|O4|Outcome|Dose Escalation, Alisertib 50 mg|Alisertib 50 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247943|NCT01397825|O3|Outcome|Dose Escalation, Alisertib 40 mg|Alisertib 40 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247944|NCT01397825|O2|Outcome|Dose Escalation, Alisertib 30 mg|Alisertib 30 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1, plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247945|NCT01397825|O1|Outcome|Safety Lead-in|Alisertib 50 mg, enteric coated tablets (ECT), orally, twice daily (BID), on Days 1 to 7 followed by a 14-day rest period in 21-day cycles plus rituximab 375 mg/m^2, intravenous (IV), infusion on Day 1 of each 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247946|NCT01397825|O4|Outcome|Dose Escalation, Alisertib 50 mg|Alisertib 50 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247947|NCT01397825|O3|Outcome|Dose Escalation, Alisertib 40 mg|Alisertib 40 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247948|NCT01397825|O2|Outcome|Dose Escalation, Alisertib 30 mg|Alisertib 30 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1, plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247949|NCT01397825|O1|Outcome|Safety Lead-in|Alisertib 50 mg, enteric coated tablets (ECT), orally, twice daily (BID), on Days 1 to 7 followed by a 14-day rest period in 21-day cycles plus rituximab 375 mg/m^2, intravenous (IV), infusion on Day 1 of each 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247950|NCT01397825|E4|Reported Event|Dose Escalation, Alisertib 50 mg|Alisertib 50 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247951|NCT01397825|E3|Reported Event|Dose Escalation, Alisertib 40 mg|Alisertib 40 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247952|NCT01397825|E2|Reported Event|Dose Escalation, Alisertib 30 mg|Alisertib 30 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m^2, IV, infusion on Day 1, plus vincristine 1.4 mg/m^2, IV (max 2 mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247953|NCT01397825|E1|Reported Event|Safety Lead-in|Alisertib 50 mg, enteric coated tablets (ECT), orally, twice daily (BID), on Days 1 to 7 followed by a 14-day rest period in 21-day cycles plus rituximab 375 mg/m^2, intravenous (IV), infusion on Day 1 of each 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
247954|NCT01397786|B4|Baseline|Total|Total of all reporting groups
247955|NCT01397786|B3|Baseline|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247956|NCT01397786|B2|Baseline|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247957|NCT01397786|B1|Baseline|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247958|NCT01397786|P3|Participant Flow|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247959|NCT01397786|P2|Participant Flow|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247960|NCT01397786|P1|Participant Flow|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786 .
247961|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247962|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247963|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247964|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247965|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247966|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247968|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247969|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247970|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247971|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247972|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247973|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247974|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247975|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247976|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247977|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247978|NCT01397786|O3|Outcome|De Novo|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247979|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247980|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247981|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247982|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247983|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247984|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247985|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247986|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247987|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247988|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
248011|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247989|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247990|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247991|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247992|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247993|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247994|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247995|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247996|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247997|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247998|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
247999|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
248000|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
248001|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
248002|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
248003|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
248004|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
248005|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
248006|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
248007|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
248008|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
248009|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
248010|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
248034|NCT01397617|P3|Participant Flow|NobelReplace Tapered Groovy|"NobelReplace Tapered Groovy implant~NobelReplace Tapered Groovy implant"
265245|NCT01344460|O2|Outcome|Unenhanced MRA|
248012|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
248013|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
248014|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
248015|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
248016|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
248017|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
248018|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
248019|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
248020|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
248021|NCT01397786|E4|Reported Event|De Novo (Phase B)|"Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. Participants who received at least 1 dose of study drug were included in this phase.~NOTE: Five participants from Phase B - Denovo were excluded in this analysis."
248022|NCT01397786|E3|Reported Event|Prior Placebo (Phase B)|"Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.~Participants who received at least 1 dose of study drug were included in this phase.~NOTE: One participant each from the trials P33110230 and P33110231 were excluded in this analysis."
248023|NCT01397786|E2|Reported Event|Prior Brexpiprazole (Phase B)|"Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. Participants who received at least 1 dose of study drug were included in this phase.~NOTE: Six participants from the trial P33110231 were excluded in this analysis."
248024|NCT01397786|E1|Reported Event|De Novo (Phase A)|"Participants underwent cross-titration to oral brexpiprazole for 4 weeks in Phase A. DeNovo participants in Phase A received brexpiprazole monotherapy starting dose of 2 mg daily at the conversion Week 4 visit (baseline visit of Phase B). Participants who received at least 1 dose of study drug were included in this phase.~NOTE: 12 participants from the trial P33110232 were excluded in this analysis."
248025|NCT01397747|B1|Baseline|Average Risk Patients|Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a noninvasive, multitarget stool DNA test with fecal immunochemical test (FIT) in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
248026|NCT01397747|P1|Participant Flow|Average Risk Patients|Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a noninvasive, multitarget stool DNA test with fecal immunochemical test (FIT) in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
248027|NCT01397747|O2|Outcome|FIT Test Results|Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a fecal immunochemical test (FIT) in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
248028|NCT01397747|O1|Outcome|Multitarget DNA Test Results|Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a noninvasive, multitarget stool DNA test in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
248029|NCT01397747|E1|Reported Event|Average Risk Patients|Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a noninvasive, multitarget stool DNA test with fecal immunochemical test (FIT) in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
248030|NCT01397617|B4|Baseline|Total|Total of all reporting groups
248031|NCT01397617|B3|Baseline|NobelReplace Tapered Groovy|"NobelReplace Tapered Groovy implant~NobelReplace Tapered Groovy implant"
248032|NCT01397617|B2|Baseline|NobelActive External|"NobelActive External implant~NobelActive External implant"
248033|NCT01397617|B1|Baseline|NobelActive Internal|"NobelActive Internal implant~NobelActive Internal implant"
248038|NCT01397617|O2|Outcome|NobelActive External|"NobelActive External implant~NobelActive External implant: Dental implant"
248039|NCT01397617|O1|Outcome|NobelActive Internal|"NobelActive Internal implant~NobelActive Internal implant: Dental implant"
248040|NCT01397617|O3|Outcome|NobelReplace Tapered Groovy|"NobelReplace Tapered Groovy implant~NobelReplace Tapered Groovy implant"
248041|NCT01397617|O2|Outcome|NobelActive Internal|"NobelActive Internal implant~NobelActive Internal implant"
248042|NCT01397617|O1|Outcome|NobelActive External|"NobelActive External implant~NobelActive External implant"
248043|NCT01397617|E3|Reported Event|NobelReplace Tapered Groovy|"NobelReplace Tapered Groovy implant~NobelReplace Tapered Groovy implant"
248044|NCT01397617|E2|Reported Event|NobelActive Internal|"NobelActive Internal implant~NobelActive Internal implant"
248045|NCT01397617|E1|Reported Event|NobelActive External|"NobelActive External implant~NobelActive External implant"
248046|NCT01397591|B1|Baseline|Ofatumumab in Combination With Bortezomib|All patients were given Ofatumumab in combination with Bortezomib in treatment cycles lasting 28 days. Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.
248047|NCT01397591|P1|Participant Flow|Ofatumumab in Combination With Bortezomib|All patients were given Ofatumumab in combination with Bortezomib in treatment cycles lasting 28 days. Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.
248048|NCT01397591|O1|Outcome|Treatment (Monoclonal Antibody and Enzyme Inhibitor Therapy)|"Patients receive ofatumumab IV over 2.5 hours on days 1 and 8 of course 1, and day 1 of all subsequent courses. Patients also receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~biopsy: Optional correlative studies~quality-of-life assessment: Ancillary studies~polymorphism analysis: Correlative studies~flow cytometry: Correlative studies"
248049|NCT01397591|O1|Outcome|Ofatumumab in Combination With Bortezomib|"All patients were given Ofatumumab in combination with Bortezomib in treatment cycles lasting 28 days. Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.~ofatumumab: Given IV~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~biopsy: Optional correlative studies~quality-of-life assessment: Ancillary studies~polymorphism analysis: Correlative studies~flow cytometry: Correlative studies"
248050|NCT01397591|O1|Outcome|Treatment (Monoclonal Antibody and Enzyme Inhibitor Therapy)|"Patients receive ofatumumab IV over 2.5 hours on days 1 and 8 of course 1, and day 1 of all subsequent courses. Patients also receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~biopsy: Optional correlative studies~quality-of-life assessment: Ancillary studies~polymorphism analysis: Correlative studies~flow cytometry: Correlative studies"
248051|NCT01397591|O1|Outcome|Treatment (Monoclonal Antibody and Enzyme Inhibitor Therapy)|"Patients receive ofatumumab IV over 2.5 hours on days 1 and 8 of course 1, and day 1 of all subsequent courses. Patients also receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~biopsy: Optional correlative studies~quality-of-life assessment: Ancillary studies~polymorphism analysis: Correlative studies~flow cytometry: Correlative studies"
248052|NCT01397591|O1|Outcome|Treatment (Monoclonal Antibody and Enzyme Inhibitor Therapy)|"Patients receive ofatumumab IV over 2.5 hours on days 1 and 8 of course 1, and day 1 of all subsequent courses. Patients also receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~biopsy: Optional correlative studies~quality-of-life assessment: Ancillary studies~polymorphism analysis: Correlative studies~flow cytometry: Correlative studies"
248053|NCT01397591|E1|Reported Event|Ofatumumab in Combination With Bortezomib|All patients were given Ofatumumab in combination with Bortezomib in treatment cycles lasting 28 days. Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.
248054|NCT01397461|B4|Baseline|Total|Total of all reporting groups
248055|NCT01397461|B3|Baseline|Retapamulin 1% Ointment|"1% ointment~retapamulin 1% ointment: ointment"
248056|NCT01397461|B2|Baseline|Ozenoxacin Placebo|"cream~ozenoxacin placebo: cream"
248057|NCT01397461|B1|Baseline|Ozenoxacin 1% Cream|"1% cream~ozenoxacin 1% cream: 1% cream"
248058|NCT01397461|P3|Participant Flow|Retapamulin 1% Ointment|"1% ointment~retapamulin 1% ointment: ointment"
248059|NCT01397461|P2|Participant Flow|Ozenoxacin Placebo|"cream~ozenoxacin placebo: cream"
248060|NCT01397461|P1|Participant Flow|Ozenoxacin 1% Cream|"1% cream~ozenoxacin 1% cream: 1% cream"
248061|NCT01397461|O3|Outcome|Retapamulin 1% Ointment|"1% ointment~retapamulin 1% ointment: ointment"
248062|NCT01397461|O2|Outcome|Ozenoxacin Placebo|"cream~ozenoxacin placebo: cream"
248063|NCT01397461|O1|Outcome|Ozenoxacin 1% Cream|"1% cream~ozenoxacin 1% cream: 1% cream"
265246|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
248068|NCT01397448|B3|Baseline|Teprenone 150 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
248069|NCT01397448|B2|Baseline|Rabeprazole 10 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
248070|NCT01397448|B1|Baseline|Rabeprazole 5 mg|Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
248071|NCT01397448|P3|Participant Flow|Teprenone 150 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
248072|NCT01397448|P2|Participant Flow|Rabeprazole 10 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
248073|NCT01397448|P1|Participant Flow|Rabeprazole 5 mg|Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
248074|NCT01397448|O3|Outcome|Teprenone 150 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
248075|NCT01397448|O2|Outcome|Rabeprazole 10 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
248076|NCT01397448|O1|Outcome|Rabeprazole 5 mg|Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
248077|NCT01397448|O3|Outcome|Teprenone 150 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
248078|NCT01397448|O2|Outcome|Rabeprazole 10 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
248079|NCT01397448|O1|Outcome|Rabeprazole 5 mg|Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
248080|NCT01397448|E3|Reported Event|Teprenone 150 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
248081|NCT01397448|E2|Reported Event|Rabeprazole 10 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
248082|NCT01397448|E1|Reported Event|Rabeprazole 5 mg|Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
248083|NCT01397422|B5|Baseline|Total|Total of all reporting groups
248084|NCT01397422|B4|Baseline|ADS-5102 (420 mg)|420 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)
248085|NCT01397422|B3|Baseline|ADS-5102 (340 mg)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
248086|NCT01397422|B2|Baseline|ADS-5102 (260 mg)|260 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks
248087|NCT01397422|B1|Baseline|Placebo|ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
248088|NCT01397422|P4|Participant Flow|ADS-5102 (420 mg)|420 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)
248089|NCT01397422|P3|Participant Flow|ADS-5102 (340 mg)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
248090|NCT01397422|P2|Participant Flow|ADS-5102 (260 mg)|260 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks
248091|NCT01397422|P1|Participant Flow|Placebo|ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
248092|NCT01397422|O4|Outcome|ADS-5102 (420 mg)|420 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)
248093|NCT01397422|O3|Outcome|ADS-5102 (340 mg)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
248094|NCT01397422|O2|Outcome|ADS-5102 (260 mg)|260 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks
248095|NCT01397422|O1|Outcome|Placebo|ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
248096|NCT01397422|O4|Outcome|ADS-5102 (420 mg)|420 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)
248097|NCT01397422|O3|Outcome|ADS-5102 (340 mg)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
248098|NCT01397422|O2|Outcome|ADS-5102 (260 mg)|260 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks
248099|NCT01397422|O1|Outcome|Placebo|ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
248100|NCT01397422|O4|Outcome|ADS-5102 (420 mg)|420 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)
248101|NCT01397422|O3|Outcome|ADS-5102 (340 mg)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
248102|NCT01397422|O2|Outcome|ADS-5102 (260 mg)|260 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks
248103|NCT01397422|O1|Outcome|Placebo|ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
248104|NCT01397422|O4|Outcome|ADS-5102 (420 mg)|420 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)
248105|NCT01397422|O3|Outcome|ADS-5102 (340 mg)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
248106|NCT01397422|O2|Outcome|ADS-5102 (260 mg)|260 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks
248107|NCT01397422|O1|Outcome|Placebo|ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
248108|NCT01397422|O4|Outcome|ADS-5102 (420 mg)|420 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)
248109|NCT01397422|O3|Outcome|ADS-5102 (340 mg)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
248110|NCT01397422|O2|Outcome|ADS-5102 (260 mg)|260 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks
248111|NCT01397422|O1|Outcome|Placebo|ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
248112|NCT01397422|O4|Outcome|ADS-5102 (420 mg)|420 mg dose of ADS-5102 (amantadine HClextended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)
248113|NCT01397422|O3|Outcome|ADS-5102 (340 mg)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
248114|NCT01397422|O2|Outcome|ADS-5102 (260 mg)|260 mg dose of ADS-5102 (amantadine HClextended release): oral capsules administered once daily at bedtime for 8 weeks
248115|NCT01397422|O1|Outcome|Placebo|ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
248116|NCT01397422|E4|Reported Event|ADS-5102 (420 mg)|420 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)
248117|NCT01397422|E3|Reported Event|ADS-5102 (340 mg)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
248118|NCT01397422|E2|Reported Event|ADS-5102 (260 mg)|260 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks
248119|NCT01397422|E1|Reported Event|Placebo|ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
248120|NCT01397409|B11|Baseline|Total|Total of all reporting groups
248121|NCT01397409|B10|Baseline|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks
248122|NCT01397409|B9|Baseline|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
248123|NCT01397409|B8|Baseline|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
248124|NCT01397409|B7|Baseline|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
248125|NCT01397409|B6|Baseline|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
248126|NCT01397409|B5|Baseline|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
248127|NCT01397409|B4|Baseline|Stage 1: AGN-150998 1.0 mg|Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
248128|NCT01397409|B3|Baseline|Stage 1: AGN-150998 2.0 mg|Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection
248129|NCT01397409|B2|Baseline|Stage 1: AGN-150998 3.0 mg|Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
248130|NCT01397409|B1|Baseline|Stage 1: AGN-150998 4.2 mg|Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
248131|NCT01397409|P10|Participant Flow|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks
248132|NCT01397409|P9|Participant Flow|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
248133|NCT01397409|P8|Participant Flow|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
248134|NCT01397409|P7|Participant Flow|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
248135|NCT01397409|P6|Participant Flow|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
248136|NCT01397409|P5|Participant Flow|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
248137|NCT01397409|P4|Participant Flow|Stage 1: AGN-150998 1.0 mg|Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
248138|NCT01397409|P3|Participant Flow|Stage 1: AGN-150998 2.0 mg|Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection
248139|NCT01397409|P2|Participant Flow|Stage 1: AGN-150998 3.0 mg|Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
248140|NCT01397409|P1|Participant Flow|Stage 1: AGN-150998 4.2 mg|Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
248141|NCT01397409|O3|Outcome|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks.
248142|NCT01397409|O2|Outcome|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16
248143|NCT01397409|O1|Outcome|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
248144|NCT01397409|O3|Outcome|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks.
248145|NCT01397409|O2|Outcome|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16
248146|NCT01397409|O1|Outcome|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
248147|NCT01397409|O3|Outcome|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
248148|NCT01397409|O2|Outcome|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
248149|NCT01397409|O1|Outcome|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
248150|NCT01397409|O3|Outcome|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
248151|NCT01397409|O2|Outcome|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
248152|NCT01397409|O1|Outcome|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
248153|NCT01397409|O3|Outcome|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
248154|NCT01397409|O2|Outcome|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
248155|NCT01397409|O1|Outcome|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
248156|NCT01397409|O3|Outcome|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks.
248157|NCT01397409|O2|Outcome|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16
248158|NCT01397409|O1|Outcome|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
248159|NCT01397409|O3|Outcome|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
248160|NCT01397409|O2|Outcome|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
248161|NCT01397409|O1|Outcome|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
248162|NCT01397409|O4|Outcome|Stage 1: AGN-150998 1.0 mg|Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection
248163|NCT01397409|O3|Outcome|Stage 1: AGN-150998 2.0 mg|Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection.
248164|NCT01397409|O2|Outcome|Stage 1: AGN-150998 3.0 mg|Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection
248165|NCT01397409|O1|Outcome|Stage 1: AGN-150998 4.2 mg|Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
248166|NCT01397409|O1|Outcome|Stage 1 All Participants|Participants in Stage 1 received an intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
248167|NCT01397409|E10|Reported Event|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks
248168|NCT01397409|E9|Reported Event|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
248169|NCT01397409|E8|Reported Event|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
248170|NCT01397409|E7|Reported Event|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
248171|NCT01397409|E6|Reported Event|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
248172|NCT01397409|E5|Reported Event|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
248173|NCT01397409|E4|Reported Event|Stage 1: AGN-150998 1.0 mg|Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
248174|NCT01397409|E3|Reported Event|Stage 1: AGN-150998 2.0 mg|Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection
248175|NCT01397409|E2|Reported Event|Stage 1: AGN-150998 3.0 mg|Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
248176|NCT01397409|E1|Reported Event|Stage 1: AGN-150998 4.2 mg|Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
248177|NCT01397253|B3|Baseline|Total|Total of all reporting groups
248458|NCT01396382|O1|Outcome|68Ga-DOTATATE PET|68Ga-DOTATATE PET scan will be administered to patients in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
248178|NCT01397253|B2|Baseline|Automated Communication Tools|"An enhanced version of MedTrak (the present system of PCP notification). Electronic medical record links will be developed and used to allow automated communication with the PCP.~Automated communication tools will include:~PCP notification of patient admission and location~Data on medications begun on admission~Automated alerts on changes in patient status and location while the patient is hospitalized~Links to the EMR and to hospital physician contact information on all email alerts~Real-time delivery of discharge information (medications, instructions, and follow-up) to the PCP~Automatic reporting to PCPs of test results pending at discharge~Electronic delivery of final discharge summaries"
248179|NCT01397253|B1|Baseline|(Usual) MedTrak System of PCP Notification|MedTrak, the information system used by the University of Pittsburgh Medical Center (UPMC), currently notifies PCPs when patients are admitted and discharged from the hospital.
248180|NCT01397253|P2|Participant Flow|Automated Communication Tools|"An enhanced version of MedTrak (the present system of PCP notification). Electronic medical record links will be developed and used to allow automated communication with the PCP.~Automated communication tools will include:~PCP notification of patient admission and location~Data on medications begun on admission~Automated alerts on changes in patient status and location while the patient is hospitalized~Links to the EMR and to hospital physician contact information on all email alerts~Real-time delivery of discharge information (medications, instructions, and follow-up) to the PCP~Automatic reporting to PCPs of test results pending at discharge~Electronic delivery of final discharge summaries"
248181|NCT01397253|P1|Participant Flow|(Usual) MedTrak System of PCP Notification|MedTrak, the information system used by the University of Pittsburgh Medical Center (UPMC), currently notifies PCPs when patients are admitted and discharged from the hospital.
248182|NCT01397253|O2|Outcome|Automated Communication Tools|"An enhanced version of MedTrak (the present system of PCP notification). Electronic medical record links will be developed and used to allow automated communication with the PCP.~Automated communication tools will include:~PCP notification of patient admission and location~Data on medications begun on admission~Automated alerts on changes in patient status and location while the patient is hospitalized~Links to the EMR and to hospital physician contact information on all email alerts~Real-time delivery of discharge information (medications, instructions, and follow-up) to the PCP~Automatic reporting to PCPs of test results pending at discharge~Electronic delivery of final discharge summaries"
248183|NCT01397253|O1|Outcome|(Usual) MedTrak System of PCP Notification|MedTrak, the information system used by the University of Pittsburgh Medical Center (UPMC), currently notifies PCPs when patients are admitted and discharged from the hospital.
248184|NCT01397253|E2|Reported Event|Automated Communication Tools|"An enhanced version of MedTrak (the present system of PCP notification). Electronic medical record links will be developed and used to allow automated communication with the PCP.~Automated communication tools will include:~PCP notification of patient admission and location~Data on medications begun on admission~Automated alerts on changes in patient status and location while the patient is hospitalized~Links to the EMR and to hospital physician contact information on all email alerts~Real-time delivery of discharge information (medications, instructions, and follow-up) to the PCP~Automatic reporting to PCPs of test results pending at discharge~Electronic delivery of final discharge summaries"
248185|NCT01397253|E1|Reported Event|(Usual) MedTrak System of PCP Notification|MedTrak, the information system used by the University of Pittsburgh Medical Center (UPMC), currently notifies PCPs when patients are admitted and discharged from the hospital.
248186|NCT01397084|B1|Baseline|Esomeprazole 20 mg|esomeprazole 20 mg : esomeprazole 20 mg once daily for 8 weeks
248187|NCT01397084|P1|Participant Flow|Esomeprazole 20 mg|esomeprazole 20 mg : esomeprazole 20 mg once daily for 8 weeks
248188|NCT01397084|O1|Outcome|Esomeprazole 20 mg|esomeprazole 20 mg once daily for 8 weeks
248189|NCT01397084|O1|Outcome|Esomeprazole 20 mg|esomeprazole 20 mg once daily for 8 weeks
248190|NCT01397084|O1|Outcome|Esomeprazole 20 mg|esomeprazole 20 mg once daily for 8 weeks
248191|NCT01397084|O1|Outcome|Esomeprazole 20 mg|esomeprazole 20 mg once daily for 8 weeks
248192|NCT01397084|E1|Reported Event|Esomeprazole 20 mg|esomeprazole 20 mg once daily for 8 weeks
248193|NCT01396525|B1|Baseline|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248194|NCT01396525|P1|Participant Flow|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248195|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248196|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248197|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248198|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248199|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248459|NCT01396382|E1|Reported Event|68Ga-DOTATATE PET Scan|Patients will receive 68Ga-DOTATATE PET scans. 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
248200|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248201|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248202|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248203|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248204|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248205|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248206|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248207|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248208|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248209|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248210|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248211|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248212|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248213|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248214|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248215|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248216|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248217|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248218|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248219|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248220|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248460|NCT01396317|B3|Baseline|Total|Total of all reporting groups
248221|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248222|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248223|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248224|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248225|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248226|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248227|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248228|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248229|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248230|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248231|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248232|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248233|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248234|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248235|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248236|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248237|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248238|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248239|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248240|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248241|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248541|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
248242|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248243|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248244|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248245|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248246|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248247|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248248|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248249|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248250|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248251|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248252|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248253|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248254|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248255|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248256|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248257|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248258|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248259|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248260|NCT01396525|O3|Outcome|Stair Climbing Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248261|NCT01396525|O2|Outcome|Walking Speed Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248262|NCT01396525|O1|Outcome|Walking Distance Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248479|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
248263|NCT01396525|O3|Outcome|Stair Climbing Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248264|NCT01396525|O2|Outcome|Walking Speed Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248265|NCT01396525|O1|Outcome|Walking Distance Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248266|NCT01396525|O3|Outcome|Stair Climbing Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248267|NCT01396525|O2|Outcome|Walking Speed Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248268|NCT01396525|O1|Outcome|Walking Distance Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248269|NCT01396525|O3|Outcome|Stair Climbing Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248270|NCT01396525|O2|Outcome|Walking Speed Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248271|NCT01396525|O1|Outcome|Walking Distance Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248272|NCT01396525|O3|Outcome|Stair Climbing Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248273|NCT01396525|O2|Outcome|Walking Speed Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248274|NCT01396525|O1|Outcome|Walking Distance Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248275|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248276|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248277|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248278|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248279|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248280|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248281|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248282|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248283|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248284|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248480|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
248542|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
248285|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248286|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248287|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248288|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248289|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248290|NCT01396525|E1|Reported Event|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
248291|NCT01396512|B3|Baseline|Total|Total of all reporting groups
248292|NCT01396512|B2|Baseline|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
248293|NCT01396512|B1|Baseline|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
248294|NCT01396512|P2|Participant Flow|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
248295|NCT01396512|P1|Participant Flow|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
248296|NCT01396512|O2|Outcome|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
248297|NCT01396512|O1|Outcome|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
248298|NCT01396512|O2|Outcome|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
248299|NCT01396512|O1|Outcome|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
248300|NCT01396512|O2|Outcome|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
248301|NCT01396512|O1|Outcome|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
248302|NCT01396512|O2|Outcome|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
248303|NCT01396512|O1|Outcome|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
248304|NCT01396512|E2|Reported Event|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
248305|NCT01396512|E1|Reported Event|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
248306|NCT01396447|B5|Baseline|Total|Total of all reporting groups
248307|NCT01396447|B4|Baseline|Cariprazine 3.0 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.
248308|NCT01396447|B3|Baseline|Cariprazine 1.5 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.
248309|NCT01396447|B2|Baseline|Cariprazine 0.75 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.
248310|NCT01396447|B1|Baseline|Placebo|Participants received placebo orally once a day for 8 weeks.
248311|NCT01396447|P4|Participant Flow|Cariprazine 3.0 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.
248312|NCT01396447|P3|Participant Flow|Cariprazine 1.5 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.
248313|NCT01396447|P2|Participant Flow|Cariprazine 0.75 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.
248314|NCT01396447|P1|Participant Flow|Placebo|Participants received placebo orally once a day for 8 weeks.
248315|NCT01396447|O4|Outcome|Cariprazine 3.0 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.
248316|NCT01396447|O3|Outcome|Cariprazine 1.5 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.
248317|NCT01396447|O2|Outcome|Cariprazine 0.75 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.
248318|NCT01396447|O1|Outcome|Placebo|Participants received placebo orally once a day for 8 weeks.
248543|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
248319|NCT01396447|O4|Outcome|Cariprazine 3.0 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.
248320|NCT01396447|O3|Outcome|Cariprazine 1.5 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.
248321|NCT01396447|O2|Outcome|Cariprazine 0.75 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.
248322|NCT01396447|O1|Outcome|Placebo|Participants received placebo orally once a day for 8 weeks.
248323|NCT01396447|E4|Reported Event|Cariprazine 3.0 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.
248324|NCT01396447|E3|Reported Event|Cariprazine 1.5 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.
248325|NCT01396447|E2|Reported Event|Cariprazine 0.75 mg|Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.
248326|NCT01396447|E1|Reported Event|Placebo|Participants received placebo orally once a day for 8 weeks.
248327|NCT01396434|B4|Baseline|Total|Total of all reporting groups
248328|NCT01396434|B3|Baseline|13vPnC (Prevenar 13), Cohort 3|13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
248329|NCT01396434|B2|Baseline|13vPnC (Prevenar 13), Cohort 2|13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.
248330|NCT01396434|B1|Baseline|13vPnC (Prevenar 13), Cohort 1|Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.
248331|NCT01396434|P3|Participant Flow|13vPnC (Prevenar 13), Cohort 3|13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
248332|NCT01396434|P2|Participant Flow|13vPnC (Prevenar 13), Cohort 2|13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.
248333|NCT01396434|P1|Participant Flow|13vPnC (Prevenar 13), Cohort 1|Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.
248334|NCT01396434|O3|Outcome|13vPnC (Prevenar 13), Cohort 3|13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
248335|NCT01396434|O2|Outcome|13vPnC (Prevenar 13), Cohort 2|13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.
248336|NCT01396434|O1|Outcome|13vPnC (Prevenar 13), Cohort 1|Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.
248337|NCT01396434|E3|Reported Event|13vPnC (Prevenar 13), Cohort 3|13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
248338|NCT01396434|E2|Reported Event|13vPnC (Prevenar 13), Cohort 2|13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.
248339|NCT01396434|E1|Reported Event|13vPnC (Prevenar 13), Cohort 1|Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.
248340|NCT01396421|B5|Baseline|Total|Total of all reporting groups
248341|NCT01396421|B4|Baseline|Placebo|Placebo tablet once daily for 6 weeks.
248342|NCT01396421|B3|Baseline|Brexpiprazole 0.25 mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
248343|NCT01396421|B2|Baseline|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
248344|NCT01396421|B1|Baseline|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
248345|NCT01396421|P4|Participant Flow|Placebo|Placebo tablet once daily for 6 weeks.
248346|NCT01396421|P3|Participant Flow|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
248347|NCT01396421|P2|Participant Flow|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
248348|NCT01396421|P1|Participant Flow|Brexpiprazole 4 mg|"Brexpiprazole 4 milligram (mg) tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
248349|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
248350|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
248544|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
248351|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
248352|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
248353|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks
248354|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
248355|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of placebo over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
248356|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of placebo over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
248357|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
248358|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
248359|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
248360|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
248361|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
248362|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
248363|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
248364|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
248365|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
248366|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
248367|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
248368|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
248369|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
248370|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
248371|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
248372|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
248373|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
248374|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
248375|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day by Day 5."
248376|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
248377|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
248378|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
248379|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
248380|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
248381|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
248382|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
248383|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
248481|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
248384|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2"
248385|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
248386|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
248387|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
248388|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
248389|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
248390|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
248391|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
248392|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
248393|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
248394|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
248395|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a r5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
248396|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
248397|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
248398|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
248399|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
248400|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
248401|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
248402|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
248403|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5)."
248404|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1),and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
248405|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
248406|NCT01396421|O3|Outcome|Brexpiprazole 0.25 mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
248407|NCT01396421|O2|Outcome|Brexpiprazole 2 mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
248408|NCT01396421|O1|Outcome|Brexpiprazole 4 mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
248409|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
248410|NCT01396421|O3|Outcome|Brexpiprazole 0.25 mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks
248411|NCT01396421|O2|Outcome|Brexpiprazole 2 mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
248412|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1),and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
248413|NCT01396421|E4|Reported Event|Placebo|Placebo tablet once daily for 6 weeks.
248414|NCT01396421|E3|Reported Event|Brexpiprazile 0.25 mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
248415|NCT01396421|E2|Reported Event|Brexpiprazole 2 mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
248416|NCT01396421|E1|Reported Event|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
248417|NCT01396395|B3|Baseline|Total|Total of all reporting groups
248418|NCT01396395|B2|Baseline|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
248419|NCT01396395|B1|Baseline|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies ( aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
248420|NCT01396395|P2|Participant Flow|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
248421|NCT01396395|P1|Participant Flow|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 milligram (mg) tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors (ACEIs) as permitted by disease condition or as per standard local practices or prescribed per discretion of the investigators.
248422|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
248423|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
248424|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
248425|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
248426|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
248427|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
248428|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
248429|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
248430|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
248431|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
248432|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
248433|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
248434|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
248435|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
248436|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
248482|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
265247|NCT01344460|O2|Outcome|Unenhanced MRA|
248437|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
248438|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
248439|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
248440|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
248441|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
248442|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
248443|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
248444|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
248445|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
248446|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
248447|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
248448|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies ( aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
248449|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
248450|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
248451|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
248452|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
248453|NCT01396395|E2|Reported Event|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
248454|NCT01396395|E1|Reported Event|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
248455|NCT01396382|B1|Baseline|Imaging/Scans|68Ga-DOTATATE PET scans performed on subjects. 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
248456|NCT01396382|P1|Participant Flow|68Ga-DOTATATE PET Scan|68Ga-DOTATATE PET scans performed on subjects. 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
248457|NCT01396382|O1|Outcome|68Ga-DOTATATE PET|68Ga-DOTATATE will be administered to patient in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
248461|NCT01396317|B2|Baseline|Control (Corticosteroid Taper Alone)|A cohort of consecutively evaluated patients with newly diagnosed PMR who declined participation in the trial, or failed to meet inclusion criteria, served as a comparator group.These patients were treated contemporaneously with the comparator group by a single rheumatologist with expertise in PMR and received glucocorticoids alone, tapered at the treating physician’s discretion, as is the standard of care in PMR.
248462|NCT01396317|B1|Baseline|Tocilizumab + Corticosteroid Taper|"All subjects will receive the open-label active study treatment for 12 months, and will then be evaluated for 3 months of long-term follow-up.~Tocilizumab: Tocilizumab is a humanized anti-interleukin-6 receptor antibody that has been FDA approved for the treatment of rheumatoid arthritis (RA). This molecule binds to the IL-6 binding site of human IL-6 receptor, and competitively inhibits IL-6 signaling."
248463|NCT01396317|P2|Participant Flow|Control (Corticosteroid Taper Alone)|A cohort of consecutively evaluated patients with newly diagnosed PMR who declined participation in the trial or failed to meet inclusion criteria served as a control group. These patients were treated contemporaneously by a single rheumatologist with expertise in PMR and received CS alone, tapered at the treating physician’s discretion.
248464|NCT01396317|P1|Participant Flow|Tocilizumab + Corticosteroid Taper|In a single-center open-label study, subjects with newly diagnosed PMR (Healey criteria) and prior treatment with <1 month of corticosteroids (CS) were treated with TCZ 8mg/kg IV monthly for 12 months plus a rapid CS taper. Subjects were followed for 15 months. Those with concurrent GCA or those treated with >30mg prednisone were excluded.
248465|NCT01396317|O2|Outcome|Control (Corticosteroid Taper Alone)|A cohort of consecutively evaluated patients with newly diagnosed PMR who declined participation in the trial, or failed to meet inclusion criteria, served as a comparator group.These patients were treated contemporaneously with the comparator group by a single rheumatologist with expertise in PMR and received glucocorticoids alone, tapered at the treating physician’s discretion, as is the standard of care in PMR.
248466|NCT01396317|O1|Outcome|Tocilizumab + Corticosteroid Taper|"All subjects will receive the open-label active study treatment for 12 months, and will then be evaluated for 3 months of long-term follow-up.~Tocilizumab: Tocilizumab is a humanized anti-interleukin-6 receptor antibody that has been FDA approved for the treatment of rheumatoid arthritis (RA). This molecule binds to the IL-6 binding site of human IL-6 receptor, and competitively inhibits IL-6 signaling."
248467|NCT01396317|O2|Outcome|Control (Corticosteroid Taper Alone)|A cohort of consecutively evaluated patients with newly diagnosed PMR who declined participation in the trial, or failed to meet inclusion criteria, served as a comparator group.These patients were treated contemporaneously with the comparator group by a single rheumatologist with expertise in PMR and received glucocorticoids alone, tapered at the treating physician’s discretion, as is the standard of care in PMR.
248468|NCT01396317|O1|Outcome|Tocilizumab + Corticosteroid Taper|"All subjects will receive the open-label active study treatment for 12 months, and will then be evaluated for 3 months of long-term follow-up.~Tocilizumab: Tocilizumab is a humanized anti-interleukin-6 receptor antibody that has been FDA approved for the treatment of rheumatoid arthritis (RA). This molecule binds to the IL-6 binding site of human IL-6 receptor, and competitively inhibits IL-6 signaling."
248469|NCT01396317|O2|Outcome|Control (Corticosteroid Taper Alone)|A cohort of consecutively evaluated patients with newly diagnosed PMR who declined participation in the trial, or failed to meet inclusion criteria, served as a comparator group.These patients were treated contemporaneously with the comparator group by a single rheumatologist with expertise in PMR and received glucocorticoids alone, tapered at the treating physician’s discretion, as is the standard of care in PMR.
248470|NCT01396317|O1|Outcome|Tocilizumab + Corticosteroid Taper|"All subjects will receive the open-label active study treatment for 12 months, and will then be evaluated for 3 months of long-term follow-up.~Tocilizumab: Tocilizumab is a humanized anti-interleukin-6 receptor antibody that has been FDA approved for the treatment of rheumatoid arthritis (RA). This molecule binds to the IL-6 binding site of human IL-6 receptor, and competitively inhibits IL-6 signaling."
248471|NCT01396317|O2|Outcome|Control (Corticosteroid Taper Alone)|A cohort of consecutively evaluated patients with newly diagnosed PMR who declined participation in the trial or failed to meet inclusion criteria served as a control group. These patients were treated contemporaneously by a single rheumatologist with expertise in PMR and received CS alone, tapered at the treating physician’s discretion.
248472|NCT01396317|O1|Outcome|Tocilizumab + Corticosteroid Taper|In a single-center open-label study, subjects with newly diagnosed PMR (Healey criteria) and prior treatment with <1 month of corticosteroids (CS) were treated with TCZ 8mg/kg IV monthly for 12 months plus a rapid CS taper. Subjects were followed for 15 months. Those with concurrent GCA or those treated with >30mg prednisone were excluded.
248473|NCT01396317|O1|Outcome|Tocilizumab|"This is a single-arm study. All subjects will receive the active study treatment for 12 months, and will then be evaluated for 3 months of long-term follow-up.~Tocilizumab: Tocilizumab is a humanized anti-interleukin-6 receptor antibody that has been FDA approved for the treatment of rheumatoid arthritis (RA). This molecule binds to the IL-6 binding site of human IL-6 receptor, and competitively inhibits IL-6 signaling."
248474|NCT01396317|O2|Outcome|Control (Corticosteroid Taper Alone)|A cohort of consecutively evaluated patients with newly diagnosed PMR who declined participation in the trial or failed to meet inclusion criteria served as a control group. These patients were treated contemporaneously by a single rheumatologist with expertise in PMR and received CS alone, tapered at the treating physician’s discretion.
248475|NCT01396317|O1|Outcome|Tocilizumab + Corticosteroid Taper|In a single-center open-label study, subjects with newly diagnosed PMR (Healey criteria) and prior treatment with <1 month of corticosteroids (CS) were treated with TCZ 8mg/kg IV monthly for 12 months plus a rapid CS taper. Subjects were followed for 15 months. Those with concurrent GCA or those treated with >30mg prednisone were excluded.
248476|NCT01396317|E1|Reported Event|Tocilizumab + Corticosteroid Taper|In a single-center open-label study, subjects with newly diagnosed PMR (Healey criteria) and prior treatment with <1 month of corticosteroids (CS) were treated with TCZ 8mg/kg IV monthly for 12 months plus a rapid CS taper. Subjects were followed for 15 months. Those with concurrent GCA or those treated with >30mg prednisone were excluded.
248477|NCT01396265|B1|Baseline|Overall Study|This was a open-label, two period, fixed sequence trial clinical phase I trial in healthy male volunteers.
248478|NCT01396265|P1|Participant Flow|Overall Group|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
248483|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
248484|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
248485|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
248486|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
248487|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
248488|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
248489|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
248490|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
248491|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
248492|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
248493|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
248494|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
248495|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
248496|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
248497|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
248498|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
248499|NCT01396265|E2|Reported Event|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
248500|NCT01396265|E1|Reported Event|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
248501|NCT01396239|B4|Baseline|Total|Total of all reporting groups
248502|NCT01396239|B3|Baseline|Placebo|Placebo: phosphate buffered saline solution identical in appearance to eteplirsen for 24 weeks
248503|NCT01396239|B2|Baseline|AVI-4658 (Eteplirsen) 50 mg/kg|50 mg/kg eteplirsen for 24 weeks
248504|NCT01396239|B1|Baseline|AVI-4658 (Eteplirsen) 30 mg/kg|30 mg/kg eteplirsen for 24 weeks
248505|NCT01396239|P4|Participant Flow|Placebo - Week 24 Biopsy|Placebo for 24 weeks with muscle biopsy at Week 24
248506|NCT01396239|P3|Participant Flow|AVI-4658 (Eteplirsen) 30 mg/kg|30 mg/kg eteplirsen for 24 weeks
248507|NCT01396239|P2|Participant Flow|Placebo - Week 12 Biopsy|Placebo for 24 Weeks with muscle Biopsy at Week 12
248508|NCT01396239|P1|Participant Flow|AVI-4658 (Eteplirsen) 50 mg/kg|50 mg/kg eteplirsen for 24 weeks
248509|NCT01396239|O3|Outcome|Placebo|Placebo for 24 weeks - Phosphate buffered saline solution identical in appearance to eteplirsen
248510|NCT01396239|O2|Outcome|AVI-4658 (Eteplirsen) - 50mg/kg|50 mg/kg eteplirsen for 24 weeks
248511|NCT01396239|O1|Outcome|AVI-4658 (Eteplirsen) - 30mg/kg|30 mg/kg eteplirsen for 24 weeks
248512|NCT01396239|O3|Outcome|Placebo|Placebo for 24 weeks - Phosphate buffered saline solution identical in appearance to eteplirsen
248513|NCT01396239|O2|Outcome|AVI-4658 (Eteplirsen) - 50mg/kg|50 mg/kg eteplirsen for 24 weeks
248514|NCT01396239|O1|Outcome|AVI-4658 (Eteplirsen) - 30mg/kg|30 mg/kg eteplirsen for 24 weeks
248515|NCT01396239|O3|Outcome|Placebo|Placebo for 24 weeks
248516|NCT01396239|O2|Outcome|50mg/kg Eteplirsen|50mg/kg eteplirsen for 24 weeks
248517|NCT01396239|O1|Outcome|30mg/kg Eteplirsen|30mg/kg eteplirsen for 24 weeks
248518|NCT01396239|O3|Outcome|Placebo|Placebo for 24 weeks
248519|NCT01396239|O2|Outcome|50 mg/kg Eteplirsen|50 mg/kg eteplirsen for 24 weeks
248520|NCT01396239|O1|Outcome|30 mg/kg Eteplirsen|30 mg/kg eteplirsen for 24 weeks
248521|NCT01396239|O4|Outcome|Placebo - Week 12 Biopsy|Placebo - Biopsied after 12 weeks of dosing
248522|NCT01396239|O3|Outcome|AVI-4658 (Eteplirsen) 50 mg/kg|50 mg/kg eteplirsen - Biopsied after 12 weeks of dosing
248523|NCT01396239|O2|Outcome|Placebo - Week 24 Biopsy|Placebo: Biopsied after 24 weeks of dosing
248524|NCT01396239|O1|Outcome|AVI-4658 (Eteplirsen) 30 mg/kg|30 mg/kg eteplirsen - Biopsied after 24 weeks of dosing
248525|NCT01396239|E3|Reported Event|Placebo|Placebo for 24 weeks - Phosphate buffered saline solution identical in appearance to eteplirsen
248526|NCT01396239|E2|Reported Event|AVI-4658 (Eteplirsen) - 50mg/kg|50 mg/kg eteplirsen for 24 weeks
248527|NCT01396239|E1|Reported Event|AVI-4658 (Eteplirsen) - 30mg/kg|30 mg/kg eteplirsen for 24 weeks
248528|NCT01396226|B3|Baseline|Total|Total of all reporting groups
248529|NCT01396226|B2|Baseline|PLACEBO|Placebo solution for infusion
248530|NCT01396226|B1|Baseline|AZD2927|AZD2927 solution for infusion
248531|NCT01396226|P2|Participant Flow|PLACEBO|Placebo solution for infusion
248532|NCT01396226|P1|Participant Flow|AZD2927|AZD2927 solution for infusion
248533|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
248534|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
248535|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
248536|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
248537|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
248538|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
248539|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
248540|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
248545|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
248546|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
248547|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
248548|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
248549|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
248550|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
248551|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
248552|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
248553|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
248554|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
248555|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
248556|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
248557|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
248558|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
248559|NCT01396226|E2|Reported Event|PLACEBO|Placebo solution for infusion
248560|NCT01396226|E1|Reported Event|AZD2927|AZD2927 solution for infusion
248561|NCT01396187|B6|Baseline|Total|Total of all reporting groups
248562|NCT01396187|B5|Baseline|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248563|NCT01396187|B4|Baseline|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248564|NCT01396187|B3|Baseline|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
248565|NCT01396187|B2|Baseline|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248566|NCT01396187|B1|Baseline|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248567|NCT01396187|P5|Participant Flow|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248568|NCT01396187|P4|Participant Flow|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248569|NCT01396187|P3|Participant Flow|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
248570|NCT01396187|P2|Participant Flow|PF-05231023 5 mg|PF-05231023 5 mg (milligram) intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248571|NCT01396187|P1|Participant Flow|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248572|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248573|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248574|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
248575|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248576|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248577|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248578|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
248579|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248580|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248581|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248582|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
248583|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248584|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248585|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248586|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
248587|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248588|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248589|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248590|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
248591|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248592|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248593|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248594|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
248837|NCT01396044|E1|Reported Event|Electronic Checklist|Electronic checklist
248595|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248596|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248597|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248598|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
248599|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248600|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248601|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248602|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
248603|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248604|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248605|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248606|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
248607|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248608|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248609|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248610|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
248611|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248612|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248613|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248614|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
248615|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248616|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248617|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248618|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
248619|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248620|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248621|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248622|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
248623|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248624|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248625|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248626|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
248627|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248628|NCT01396187|O5|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248629|NCT01396187|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248630|NCT01396187|O3|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
248631|NCT01396187|O2|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248632|NCT01396187|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248633|NCT01396187|O5|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248634|NCT01396187|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248635|NCT01396187|O3|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
248636|NCT01396187|O2|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248637|NCT01396187|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248638|NCT01396187|O5|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248639|NCT01396187|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248640|NCT01396187|O3|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
248641|NCT01396187|O2|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248642|NCT01396187|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248643|NCT01396187|O5|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248644|NCT01396187|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248645|NCT01396187|O3|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
248646|NCT01396187|O2|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248647|NCT01396187|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248648|NCT01396187|O5|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248649|NCT01396187|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248650|NCT01396187|O3|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
248651|NCT01396187|O2|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248652|NCT01396187|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248653|NCT01396187|O5|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248654|NCT01396187|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248655|NCT01396187|O3|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
248656|NCT01396187|O2|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248657|NCT01396187|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248658|NCT01396187|E5|Reported Event|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248659|NCT01396187|E4|Reported Event|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248660|NCT01396187|E3|Reported Event|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
248661|NCT01396187|E2|Reported Event|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248662|NCT01396187|E1|Reported Event|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
248663|NCT01396161|B8|Baseline|Total|Total of all reporting groups
248664|NCT01396161|B7|Baseline|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
248665|NCT01396161|B6|Baseline|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
248666|NCT01396161|B5|Baseline|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules PF-05175157 QD for 14 days
248667|NCT01396161|B4|Baseline|PF-05175157 100 mg QD -HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
248668|NCT01396161|B3|Baseline|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
248669|NCT01396161|B2|Baseline|Placebo - T2DM|T2DM participants administered orally matched placebo capsules QD for 14 days
248670|NCT01396161|B1|Baseline|Placebo - HOV|HOV participants administered orally matched placebo capsules QD for 14 days
248671|NCT01396161|P7|Participant Flow|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
248672|NCT01396161|P6|Participant Flow|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 twice daily (BID) for 14 days
248673|NCT01396161|P5|Participant Flow|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
248674|NCT01396161|P4|Participant Flow|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
248675|NCT01396161|P3|Participant Flow|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 milligram (mg) capsules of PF-05175157 QD for 14 days
248676|NCT01396161|P2|Participant Flow|Placebo - Type 2 Diabetes Mellitus Participants (T2DM)|T2DM participants administered orally matched placebo capsules QD for 14 days
248677|NCT01396161|P1|Participant Flow|Placebo - Healthy and Overweight Participants (HOV)|HOV participants administered orally matched placebo capsules once daily (QD) for 14 days
248678|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
248679|NCT01396161|O4|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
248680|NCT01396161|O3|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
248681|NCT01396161|O2|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
248682|NCT01396161|O1|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
248683|NCT01396161|O7|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
248684|NCT01396161|O6|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
248685|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
248686|NCT01396161|O4|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
248687|NCT01396161|O3|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
248688|NCT01396161|O2|Outcome|Placebo - T2DM|T2DM participants administered orally matched placebo capsules QD for 14 days
248689|NCT01396161|O1|Outcome|Placebo - HOV|HOV participants administered orally matched placebo capsules QD for 14 days
248690|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
248691|NCT01396161|O4|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
248692|NCT01396161|O3|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
248693|NCT01396161|O2|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
248694|NCT01396161|O1|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
248695|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
248696|NCT01396161|O4|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
248697|NCT01396161|O3|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
248698|NCT01396161|O2|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
248699|NCT01396161|O1|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
248700|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
248701|NCT01396161|O4|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
248702|NCT01396161|O3|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
248703|NCT01396161|O2|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
248704|NCT01396161|O1|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
248705|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
248706|NCT01396161|O4|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
248707|NCT01396161|O3|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
248708|NCT01396161|O2|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
248709|NCT01396161|O1|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
248710|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
248711|NCT01396161|O4|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
248712|NCT01396161|O3|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
248713|NCT01396161|O2|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
248714|NCT01396161|O1|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
248715|NCT01396161|O7|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
248716|NCT01396161|O6|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
248717|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
248718|NCT01396161|O4|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
248719|NCT01396161|O3|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
248720|NCT01396161|O2|Outcome|Placebo - T2DM|T2DM participants administered orally matched placebo capsules QD for 14 days
248721|NCT01396161|O1|Outcome|Placebo - HOV|HOV participants administered orally matched placebo capsules QD for 14 days
248722|NCT01396161|E7|Reported Event|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
248723|NCT01396161|E6|Reported Event|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
248724|NCT01396161|E5|Reported Event|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
248725|NCT01396161|E4|Reported Event|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
248726|NCT01396161|E3|Reported Event|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
248727|NCT01396161|E2|Reported Event|Placebo - T2DM|T2DM participants administered orally matched placebo capsules QD for 14 days
248728|NCT01396161|E1|Reported Event|Placebo - HOV|HOV participants administered orally matched placebo capsules QD for 14 days
248729|NCT01396148|B1|Baseline|Sunitinib|Participants received Sunitinib capsules orally at a dose based on body surface area (BSA) (minimum dose of 15 milligram/ meter square [mg/m^2] up to a maximum dose of 30 mg/m^2) once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) until completion of study treatment, disease progression, unacceptable toxicity, required a treatment rest (greater than [>4] weeks), withdrawal of participant consent, or if other withdrawal criteria were met.
248776|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
248777|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
248730|NCT01396148|P1|Participant Flow|Sunitinib|Participants received Sunitinib capsules orally at a dose based on body surface area (BSA) (minimum dose of 15 milligram/ meter square [mg/m^2] up to a maximum dose of 30 mg/m^2) once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) until completion of study treatment, disease progression, unacceptable toxicity, required a treatment rest (greater than [>4] weeks), withdrawal of participant consent, or if other withdrawal criteria were met.
248731|NCT01396148|O1|Outcome|Sunitinib|Participants received Sunitinib capsules orally at a dose based on body surface area (BSA) (minimum dose of 15 milligram/ meter square [mg/m^2] up to a maximum dose of 30 mg/m^2) once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) until completion of study treatment, disease progression, unacceptable toxicity, required a treatment rest (greater than [>4] weeks), withdrawal of participant consent, or if other withdrawal criteria were met.
248732|NCT01396148|O1|Outcome|Sunitinib|Participants received Sunitinib capsules orally at a dose based on body surface area (BSA) (minimum dose of 15 milligram/ meter square [mg/m^2] up to a maximum dose of 30 mg/m^2) once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) until completion of study treatment, disease progression, unacceptable toxicity, required a treatment rest (greater than [>4] weeks), withdrawal of participant consent, or if other withdrawal criteria were met.
248733|NCT01396148|O1|Outcome|Sunitinib|Participants received Sunitinib capsules orally at a dose based on body surface area (BSA) (minimum dose of 15 milligram/ meter square [mg/m^2] up to a maximum dose of 30 mg/m^2) once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) until completion of study treatment, disease progression, unacceptable toxicity, required a treatment rest (greater than [>4] weeks), withdrawal of participant consent, or if other withdrawal criteria were met.
248734|NCT01396148|O2|Outcome|Sunitinib: Higher Exposure|Participants who received Sunitinib capsules orally at a dose based on BSA (minimum dose of 15 mg/m^2 up to a maximum dose of 30 mg/m^2 once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) and had total drug (sunitinib + SU012662) trough plasma concentration (Ctrough) >= the median Ctrough value
248735|NCT01396148|O1|Outcome|Sunitinib: Lower Exposure|Participants who received Sunitinib capsules orally at a dose based on BSA (minimum dose of 15 mg/m^2 up to a maximum dose of 30 mg/m^2 once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) and had total drug (sunitinib + SU012662) trough plasma concentration (Ctrough) < the median Ctrough value
248736|NCT01396148|O2|Outcome|Sunitinib: Higher Exposure|Participants who received Sunitinib capsules orally at a dose based on BSA (minimum dose of 15 mg/m^2 up to a maximum dose of 30 mg/m^2 once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) and had total drug (sunitinib + SU012662) trough plasma concentration (Ctrough) >= the median Ctrough value
248737|NCT01396148|O1|Outcome|Sunitinib: Lower Exposure|Participants who received Sunitinib capsules orally at a dose based on BSA (minimum dose of 15 mg/m^2 up to a maximum dose of 30 mg/m^2 once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) and had total drug (sunitinib + SU012662) trough plasma concentration (Ctrough) < the median Ctrough value
248738|NCT01396148|O1|Outcome|Sunitinib|Participants received Sunitinib capsules orally at a dose based on body surface area (BSA) (minimum dose of 15 milligram/ meter square [mg/m^2] up to a maximum dose of 30 mg/m^2) once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) until completion of study treatment, disease progression, unacceptable toxicity, required a treatment rest (greater than [>4] weeks), withdrawal of participant consent, or if other withdrawal criteria were met.
248739|NCT01396148|O1|Outcome|Sunitinib|Participants received Sunitinib capsules orally at a dose based on body surface area (BSA) (minimum dose of 15 milligram/ meter square [mg/m^2] up to a maximum dose of 30 mg/m^2) once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) until completion of study treatment, disease progression, unacceptable toxicity, required a treatment rest (greater than [>4] weeks), withdrawal of participant consent, or if other withdrawal criteria were met.
248740|NCT01396148|O2|Outcome|Sunitinib: Higher Exposure|Participants who received Sunitinib capsules orally at a dose based on BSA (minimum dose of 15 mg/m^2 up to a maximum dose of 30 mg/m^2 once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) and had total drug (sunitinib + SU012662) trough plasma concentration (Ctrough) >= the median Ctrough value
248741|NCT01396148|O1|Outcome|Sunitinib: Lower Exposure|Participants who received Sunitinib capsules orally at a dose based on BSA (minimum dose of 15 mg/m^2 up to a maximum dose of 30 mg/m^2 once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) and had total drug (sunitinib + SU012662) trough plasma concentration (Ctrough) < the median Ctrough value
248742|NCT01396148|O1|Outcome|Sunitinib|Participants received Sunitinib capsules orally at a dose based on body surface area (BSA) (minimum dose of 15 milligram/ meter square [mg/m^2] up to a maximum dose of 30 mg/m^2) once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) until completion of study treatment, disease progression, unacceptable toxicity, required a treatment rest (greater than [>4] weeks), withdrawal of participant consent, or if other withdrawal criteria were met.
248743|NCT01396148|O1|Outcome|Sunitinib|Participants received Sunitinib capsules orally at a dose based on body surface area (BSA) (minimum dose of 15 milligram/ meter square [mg/m^2] up to a maximum dose of 30 mg/m^2) once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) until completion of study treatment, disease progression, unacceptable toxicity, required a treatment rest (greater than [>4] weeks), withdrawal of participant consent, or if other withdrawal criteria were met.
248744|NCT01396148|O1|Outcome|Sunitinib|Participants received Sunitinib capsules orally at a dose based on body surface area (BSA) (minimum dose of 15 milligram/ meter square [mg/m^2] up to a maximum dose of 30 mg/m^2) once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) until completion of study treatment, disease progression, unacceptable toxicity, required a treatment rest (greater than [>4] weeks), withdrawal of participant consent, or if other withdrawal criteria were met.
248745|NCT01396148|O1|Outcome|Sunitinib|Participants received Sunitinib capsules orally at a dose based on body surface area (BSA) (minimum dose of 15 milligram/ meter square [mg/m^2] up to a maximum dose of 30 mg/m^2) once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) until completion of study treatment, disease progression, unacceptable toxicity, required a treatment rest (greater than [>4] weeks), withdrawal of participant consent, or if other withdrawal criteria were met.
248746|NCT01396148|O1|Outcome|Sunitinib|Participants received Sunitinib capsules orally at a dose based on body surface area (BSA) (minimum dose of 15 milligram/ meter square [mg/m^2] up to a maximum dose of 30 mg/m^2) once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) until completion of study treatment, disease progression, unacceptable toxicity, required a treatment rest (greater than [>4] weeks), withdrawal of participant consent, or if other withdrawal criteria were met.
248747|NCT01396148|O1|Outcome|Sunitinib|Participants received Sunitinib capsules orally at a dose based on body surface area (BSA) (minimum dose of 15 milligram/ meter square [mg/m^2] up to a maximum dose of 30 mg/m^2) once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) until completion of study treatment, disease progression, unacceptable toxicity, required a treatment rest (greater than [>4] weeks), withdrawal of participant consent, or if other withdrawal criteria were met.
248748|NCT01396148|O1|Outcome|Sunitinib|Participants received Sunitinib capsules orally at a dose based on body surface area (BSA) (minimum dose of 15 milligram/ meter square [mg/m^2] up to a maximum dose of 30 mg/m^2) once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) until completion of study treatment, disease progression, unacceptable toxicity, required a treatment rest (greater than [>4] weeks), withdrawal of participant consent, or if other withdrawal criteria were met.
248749|NCT01396148|O1|Outcome|Sunitinib|Participants received Sunitinib capsules orally at a dose based on body surface area (BSA) (minimum dose of 15 milligram/ meter square [mg/m^2] up to a maximum dose of 30 mg/m^2) once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) until completion of study treatment, disease progression, unacceptable toxicity, required a treatment rest (greater than [>4] weeks), withdrawal of participant consent, or if other withdrawal criteria were met.
248750|NCT01396148|O1|Outcome|Sunitinib|Participants received Sunitinib capsules orally at a dose based on body surface area (BSA) (minimum dose of 15 milligram/ meter square [mg/m^2] up to a maximum dose of 30 mg/m^2) once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) until completion of study treatment, disease progression, unacceptable toxicity, required a treatment rest (greater than [>4] weeks), withdrawal of participant consent, or if other withdrawal criteria were met.
248751|NCT01396148|O1|Outcome|Sunitinib|Participants received Sunitinib capsules orally at a dose based on body surface area (BSA) (minimum dose of 15 milligram/ meter square [mg/m^2] up to a maximum dose of 30 mg/m^2) once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) until completion of study treatment, disease progression, unacceptable toxicity, required a treatment rest (greater than [>4] weeks), withdrawal of participant consent, or if other withdrawal criteria were met.
248752|NCT01396148|O1|Outcome|Sunitinib|Participants received Sunitinib capsules orally at a dose based on body surface area (BSA) (minimum dose of 15 milligram/ meter square [mg/m^2] up to a maximum dose of 30 mg/m^2) once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) until completion of study treatment, disease progression, unacceptable toxicity, required a treatment rest (greater than [>4] weeks), withdrawal of participant consent, or if other withdrawal criteria were met.
248753|NCT01396148|E1|Reported Event|Sunitinib|Participants received Sunitinib capsules orally at a dose based on body surface area (BSA) (minimum dose of 15 milligram/ meter square [mg/m^2] up to a maximum dose of 30 mg/m^2) once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) until completion of study treatment, disease progression, unacceptable toxicity, required a treatment rest (greater than [>4] weeks), withdrawal of participant consent, or if other withdrawal criteria were met.
248754|NCT01396083|B3|Baseline|Total|Total of all reporting groups
248755|NCT01396083|B2|Baseline|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
248756|NCT01396083|B1|Baseline|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
248757|NCT01396083|P2|Participant Flow|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
248758|NCT01396083|P1|Participant Flow|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
248759|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
248760|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
248761|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
248762|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
248763|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
248764|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
248765|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
248766|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
248767|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
248768|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
248769|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
248770|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
248771|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
248772|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
248773|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
248774|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
248775|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
248836|NCT01396044|E2|Reported Event|Verbal Prompting|Verbal prompting with written checklist
248778|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
248779|NCT01396083|E2|Reported Event|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
248780|NCT01396083|E1|Reported Event|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
248781|NCT01396070|B1|Baseline|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)
248782|NCT01396070|P1|Participant Flow|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)
248783|NCT01396070|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)
248784|NCT01396070|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)
248785|NCT01396070|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)
248786|NCT01396070|O1|Outcome|Overall Response Rate (%)|Overall Response Rate of all patients
248787|NCT01396070|E1|Reported Event|All Participants|All reported AE's on trial
248788|NCT01396057|B3|Baseline|Total|Total of all reporting groups
248789|NCT01396057|B2|Baseline|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
248790|NCT01396057|B1|Baseline|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
248791|NCT01396057|P2|Participant Flow|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
248792|NCT01396057|P1|Participant Flow|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
248793|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
248794|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
248795|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
248796|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
248797|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
248798|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
248799|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
248800|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
248801|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
248802|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
248803|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
248804|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
248805|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
248806|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
248807|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
248808|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
248809|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
248810|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
248811|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
248812|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
248813|NCT01396057|E2|Reported Event|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
248814|NCT01396057|E1|Reported Event|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
248815|NCT01396044|B3|Baseline|Total|Total of all reporting groups
248816|NCT01396044|B2|Baseline|Verbal Prompting|Verbal prompting with written checklist
248817|NCT01396044|B1|Baseline|Electronic Checklist|Electronic checklist
248818|NCT01396044|P2|Participant Flow|Verbal Prompting|Verbal prompting with written checklist
248819|NCT01396044|P1|Participant Flow|Electronic Checklist|Electronic checklist
248820|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
248821|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
248822|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
248823|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
248824|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
248825|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
248826|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
248827|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
248828|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
248829|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
248830|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
248831|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
248832|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
248833|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
248834|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
248835|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
248839|NCT01396005|B2|Baseline|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
248840|NCT01396005|B1|Baseline|Methadone + Boceprevir|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
248841|NCT01396005|P2|Participant Flow|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
248842|NCT01396005|P1|Participant Flow|Methadone + Boceprevir|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
248843|NCT01396005|O2|Outcome|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
248844|NCT01396005|O1|Outcome|Buprenorphine/Naloxone Alone|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
248845|NCT01396005|O2|Outcome|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
248846|NCT01396005|O1|Outcome|Buprenorphine/Naloxone Alone|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
248847|NCT01396005|O2|Outcome|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
248848|NCT01396005|O1|Outcome|Buprenorphine/Naloxone Alone|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
248849|NCT01396005|O2|Outcome|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
248850|NCT01396005|O1|Outcome|Buprenorphine/Naloxone Alone|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
248851|NCT01396005|O2|Outcome|Methadone + Boceprevir|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
248852|NCT01396005|O1|Outcome|Methadone Alone|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
248853|NCT01396005|O2|Outcome|Methadone + Boceprevir|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
248854|NCT01396005|O1|Outcome|Methadone Alone|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
248855|NCT01396005|E2|Reported Event|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
248856|NCT01396005|E1|Reported Event|Methadone + Boceprevir|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
248857|NCT01395966|B4|Baseline|Total|Total of all reporting groups
248858|NCT01395966|B3|Baseline|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
248859|NCT01395966|B2|Baseline|DF277|"Ear drops~DF277: Ear drops"
248860|NCT01395966|B1|Baseline|DF289|"Ear drops~DF289: Ear drops"
248861|NCT01395966|P3|Participant Flow|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
248862|NCT01395966|P2|Participant Flow|DF277|"Ear drops~DF277: Ear drops"
248863|NCT01395966|P1|Participant Flow|DF289|"Ear drops~DF289: Ear drops"
248864|NCT01395966|O3|Outcome|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
248865|NCT01395966|O2|Outcome|DF277|"Ear drops~DF277: Ear drops"
248866|NCT01395966|O1|Outcome|DF289|"Ear drops~DF289: Ear drops"
248867|NCT01395966|E3|Reported Event|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
248868|NCT01395966|E2|Reported Event|DF277|"Ear drops~DF277: Ear drops"
248869|NCT01395966|E1|Reported Event|DF289|"Ear drops~DF289: Ear drops"
248870|NCT01395914|B3|Baseline|Total|Total of all reporting groups
248871|NCT01395914|B2|Baseline|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
248872|NCT01395914|B1|Baseline|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
248873|NCT01395914|P2|Participant Flow|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
248874|NCT01395914|P1|Participant Flow|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
249566|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
248875|NCT01395914|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
248876|NCT01395914|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
248877|NCT01395914|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
248878|NCT01395914|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
248879|NCT01395914|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
248880|NCT01395914|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
248881|NCT01395914|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
248882|NCT01395914|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
248883|NCT01395914|E2|Reported Event|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
248884|NCT01395914|E1|Reported Event|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
248885|NCT01395901|B3|Baseline|Total|Total of all reporting groups
248886|NCT01395901|B2|Baseline|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
248887|NCT01395901|B1|Baseline|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
248888|NCT01395901|P2|Participant Flow|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
248889|NCT01395901|P1|Participant Flow|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
248890|NCT01395901|O2|Outcome|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
248891|NCT01395901|O1|Outcome|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
248892|NCT01395901|O2|Outcome|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
248893|NCT01395901|O1|Outcome|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
248894|NCT01395901|O2|Outcome|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
248895|NCT01395901|O1|Outcome|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
248896|NCT01395901|O2|Outcome|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
248897|NCT01395901|O1|Outcome|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
248898|NCT01395901|O2|Outcome|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
248899|NCT01395901|O1|Outcome|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
248900|NCT01395901|E2|Reported Event|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
248901|NCT01395901|E1|Reported Event|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
248902|NCT01395888|B3|Baseline|Total|Total of all reporting groups
248903|NCT01395888|B2|Baseline|Tiotropium Bromide 18 µg|Participants self-administered one inhalation of placebo via an DPI followed by 2 inhalations from a single capsule containing Tiotropiuum Bromide 18 µg via a HandiHaler. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of COPD symptoms.
248904|NCT01395888|B1|Baseline|FF/VI 100/25 µg|Participants self-administered one inhalation of Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) via a dry powder inhaler (DPI) followed by 2 inhalations from a single placebo capsule delivered via a HandiHaler in the morning for 12 weeks. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of Chronic Obstructive Pulmonary Disease (COPD) symptoms.
248990|NCT01395784|O1|Outcome|All Participants|Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.
248905|NCT01395888|P3|Participant Flow|Tiotropium Bromide 18 µg|Participants self-administered one inhalation of placebo via an DPI followed by 2 inhalations from a single capsule containing Tiotropiuum Bromide 18 µg via a HandiHaler. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of COPD symptoms.
248906|NCT01395888|P2|Participant Flow|FF/VI 100/25 µg|Participants (par.) self-administered one inhalation of Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) via a dry powder inhaler (DPI) followed by 2 inhalations from a single placebo capsule delivered via a HandiHaler in the morning for 12 weeks. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of Chronic Obstructive Pulmonary Disease (COPD) symptoms.
248907|NCT01395888|P1|Participant Flow|Salb/Alb + IBr|Participants were provided with an inhaled short-acting beta2-receptor agonist, salbutamol/albuterol (Salb/Alb), for use as needed throughout the Run-in Period for relief of chronic obstructive pulmonary disease (COPD) symptoms. Ipratropium bromide (IBr) was permitted during the Run-in Period and for up to 4 hours prior to Randomization (Visit 2) if the participant was on a stable dose prior to Screening (Visit 1). Following randomization, IBr was not permitted during exposure to study treatment.
248908|NCT01395888|O2|Outcome|Tiotropium Bromide 18 µg|Participants self-administered one inhalation of placebo via an DPI followed by 2 inhalations from a single capsule containing Tiotropiuum Bromide 18 µg via a HandiHaler. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of COPD symptoms.
248909|NCT01395888|O1|Outcome|FF/VI 100/25 µg|Participants self-administered one inhalation of Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) via a dry powder inhaler (DPI) followed by 2 inhalations from a single placebo capsule delivered via a HandiHaler in the morning for 12 weeks. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of Chronic Obstructive Pulmonary Disease (COPD) symptoms.
248910|NCT01395888|E2|Reported Event|Tiotropium Bromide 18 µg|Participants self-administered one inhalation of placebo via an DPI followed by 2 inhalations from a single capsule containing Tiotropiuum Bromide 18 µg via a HandiHaler. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of COPD symptoms.
248911|NCT01395888|E1|Reported Event|FF/VI 100/25 µg|Participants self-administered one inhalation of Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) via a dry powder inhaler (DPI) followed by 2 inhalations from a single placebo capsule delivered via a HandiHaler in the morning for 12 weeks. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of Chronic Obstructive Pulmonary Disease (COPD) symptoms.
248912|NCT01395823|B3|Baseline|Total|Total of all reporting groups
248913|NCT01395823|B2|Baseline|Placebo|placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
248914|NCT01395823|B1|Baseline|Ergocalciferol Supplementation|ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
248915|NCT01395823|P2|Participant Flow|Placebo|placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
248916|NCT01395823|P1|Participant Flow|Ergocalciferol Supplementation|ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
248917|NCT01395823|O2|Outcome|Placebo|placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
248918|NCT01395823|O1|Outcome|Ergocalciferol Supplementation|ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
248919|NCT01395823|E2|Reported Event|Placebo|placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
248920|NCT01395823|E1|Reported Event|Ergocalciferol Supplementation|ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
248921|NCT01395810|B5|Baseline|Total|Total of all reporting groups
248922|NCT01395810|B4|Baseline|On-demand|Subjects in the on-demand group were administered with the single dose of 40 IU/kg of nonacog beta pegol. The recommended dose for treatment of a mild or moderate bleeding episode, for example a joint bleed, was a single dose of 40 IU/kg nonacog beta pegol. If there was no observed effect of 40 IU/kg, the investigator was to be contacted prior to administration of the second dose of 40 IU/kg. The recommended dose for severe bleeds was 80 IU/kg nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
248923|NCT01395810|B3|Baseline|Prophylaxis 80 IU/kg|Subjects were dosed with 80 IU/kg every second week. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
248924|NCT01395810|B2|Baseline|Prophylaxis 40 IU/kg|Subjects were given 40 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
248925|NCT01395810|B1|Baseline|Prophylaxis 10 IU/kg|Subjects were given 10 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
248991|NCT01395784|E1|Reported Event|All Participants|Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.
248992|NCT01395758|B3|Baseline|Total|Total of all reporting groups
265248|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
248926|NCT01395810|P4|Participant Flow|On-demand|Subjects in the on-demand group were administered with the single dose of 40 IU/kg of nonacog beta pegol. The recommended dose for treatment of a mild or moderate bleeding episode, for example a joint bleed, was a single dose of 40 IU/kg nonacog beta pegol. If there was no observed effect of 40 IU/kg, the investigator was to be contacted prior to administration of the second dose of 40 IU/kg. The recommended dose for severe bleeds was 80 IU/kg nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
248927|NCT01395810|P3|Participant Flow|Prophylaxis 80 IU/kg|Subjects were dosed with 80 IU/kg every second week. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
248928|NCT01395810|P2|Participant Flow|Prophylaxis 40 IU/kg|Subjects were given 40 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
248929|NCT01395810|P1|Participant Flow|Prophylaxis 10 IU/kg|Subjects were given 10 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an intravenous (i.v.) bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
248930|NCT01395810|O4|Outcome|On-demand|Subjects in the on-demand group were administered with the single dose of 40 IU/kg of nonacog beta pegol. The recommended dose for treatment of a mild or moderate bleeding episode, for example a joint bleed, was a single dose of 40 IU/kg nonacog beta pegol. If there was no observed effect of 40 IU/kg, the investigator was to be contacted prior to administration of the second dose of 40 IU/kg. The recommended dose for severe bleeds was 80 IU/kg nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
248931|NCT01395810|O3|Outcome|Prophylaxis 80 IU/kg|Subjects were dosed with 80 IU/kg every second week. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
248932|NCT01395810|O2|Outcome|Prophylaxis 40 IU/kg|Subjects were given 40 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
248933|NCT01395810|O1|Outcome|Prophylaxis 10 IU/kg|Subjects were given 10 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
248934|NCT01395810|O4|Outcome|On-demand|Subjects in the on-demand group were administered with the single dose of 40 IU/kg of nonacog beta pegol. The recommended dose for treatment of a mild or moderate bleeding episode, for example a joint bleed, was a single dose of 40 IU/kg nonacog beta pegol. If there was no observed effect of 40 IU/kg, the investigator was to be contacted prior to administration of the second dose of 40 IU/kg. The recommended dose for severe bleeds was 80 IU/kg nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
248935|NCT01395810|O3|Outcome|Prophylaxis 80 IU/kg|Subjects were dosed with 80 IU/kg every second week. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
248936|NCT01395810|O2|Outcome|Prophylaxis 40 IU/kg|Subjects were given 40 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
248937|NCT01395810|O1|Outcome|Prophylaxis 10 IU/kg|Subjects were given 10 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
248938|NCT01395810|O2|Outcome|Prophylaxis 40 IU/kg|Subjects were given 40 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
249090|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
248939|NCT01395810|O1|Outcome|Prophylaxis 10 IU/kg|Subjects were given 10 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
248940|NCT01395810|O3|Outcome|Prophylaxis 80 IU/kg|Subjects were dosed with 80 IU/kg every second week. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
248941|NCT01395810|O2|Outcome|Prophylaxis 40 IU/kg|Subjects were given 40 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
248942|NCT01395810|O1|Outcome|Prophylaxis 10 IU/kg|Subjects were given 10 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
248943|NCT01395810|O5|Outcome|Total|Subjects received nonacog beta pegol as prophylaxis treatment or on-demand treatment. Subjects in the prophylaxis treatment received either 10 IU/kg once weekly, 40 IU/kg once weekly or 80 IU/kg once every second week. Subjects in the on-demand group were administered with a single dose of 40 IU/kg of nonacog beta pegol. Subjects with on-demand treatment and prophylaxis treatments who experienced a bleeding episode were to be treated with single dose of 40 IU/kg unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
248944|NCT01395810|O4|Outcome|On-demand|Subjects in the on-demand group were administered with the single dose of 40 IU/kg of nonacog beta pegol. The recommended dose for treatment of a mild or moderate bleeding episode, for example a joint bleed, was a single dose of 40 IU/kg nonacog beta pegol. If there was no observed effect of 40 IU/kg, the investigator was to be contacted prior to administration of the second dose of 40 IU/kg. The recommended dose for severe bleeds was 80 IU/kg nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
248945|NCT01395810|O3|Outcome|Prophylaxis 80 IU/kg|Subjects were dosed with 80 IU/kg every second week. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
248946|NCT01395810|O2|Outcome|Prophylaxis 40 IU/kg|Subjects were given 40 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
248947|NCT01395810|O1|Outcome|Prophylaxis 10 IU/kg|Subjects were given 10 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
248948|NCT01395810|O4|Outcome|On-demand|Subjects in the on-demand group were administered with the single dose of 40 IU/kg of nonacog beta pegol. The recommended dose for treatment of a mild or moderate bleeding episode, for example a joint bleed, was a single dose of 40 IU/kg nonacog beta pegol. If there was no observed effect of 40 IU/kg, the investigator was to be contacted prior to administration of the second dose of 40 IU/kg. The recommended dose for severe bleeds was 80 IU/kg nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
248949|NCT01395810|O3|Outcome|Prophylaxis 80 IU/kg|Subjects were dosed with 80 IU/kg every second week. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
248950|NCT01395810|O2|Outcome|Prophylaxis 40 IU/kg|Subjects were given 40 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
248951|NCT01395810|O1|Outcome|Prophylaxis 10 IU/kg|Subjects were given 10 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
248952|NCT01395810|E4|Reported Event|On-demand|Subjects in the on-demand group were administered with the single dose of 40 IU/kg of nonacog beta pegol. The recommended dose for treatment of a mild or moderate bleeding episode, for example a joint bleed, was a single dose of 40 IU/kg nonacog beta pegol. If there was no observed effect of 40 IU/kg, the investigator was to be contacted prior to administration of the second dose of 40 IU/kg. The recommended dose for severe bleeds was 80 IU/kg nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
248953|NCT01395810|E3|Reported Event|Prophylaxis 80 U/kg|Subjects were dosed with 80 IU/kg every second week. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
248954|NCT01395810|E2|Reported Event|Prophylaxis 40 U/kg|Subjects were given 40 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
248955|NCT01395810|E1|Reported Event|Prophylaxis 10 U/kg|Subjects were given 10 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an intravenous (i.v.) bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
248956|NCT01395797|B7|Baseline|Total|Total of all reporting groups
248957|NCT01395797|B6|Baseline|Pio High Dose - Nicotine|"High dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
248958|NCT01395797|B5|Baseline|Pio Low Dose - Nicotine|"Low dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
248959|NCT01395797|B4|Baseline|Placebo - Nicotine|"Control condition for active arms.~Pioglitazone: 0, 15, and 45 mg per day."
248960|NCT01395797|B3|Baseline|Pio High Dose - Heroin|"High dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
248961|NCT01395797|B2|Baseline|Pio Low Dose - Heroin|"Low dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
248962|NCT01395797|B1|Baseline|Placebo - Heroin|"Control condition for active arms.~Placebo: Placebo - Heroin"
248963|NCT01395797|P6|Participant Flow|Pio High Dose - Nicotine|"High dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
248964|NCT01395797|P5|Participant Flow|Pio Low Dose - Nicotine|"Low dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
248965|NCT01395797|P4|Participant Flow|Placebo - Nicotine|"Control condition for active arms.~Pioglitazone: 0, 15, and 45 mg per day."
248966|NCT01395797|P3|Participant Flow|Pio High Dose - Heroin|"High dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
248967|NCT01395797|P2|Participant Flow|Pio Low Dose - Heroin|"Low dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
248968|NCT01395797|P1|Participant Flow|Placebo - Heroin|"Control condition for active arms.~Placebo: Placebo - Heroin"
248969|NCT01395797|O6|Outcome|Pio High Dose - Nicotine|Participants will be maintained on 45 mg of PIO prior to sessions assessing the abuse liability of nicotine
248970|NCT01395797|O5|Outcome|Pio Low Dose- Nicotine|Participants will be maintained on 15 mg of PIO prior to assessing the abuse liability of nicotine.
248971|NCT01395797|O4|Outcome|Placebo - Nicotine|Participants will be maintained on 0 mg of PIO prior to sessions assessing the abuse liability of nicotine.
248972|NCT01395797|O3|Outcome|Pio High Dose - Heroin|Participants will be maintained on 45 mg of PIO prior to sessions assessing the abuse liability of heroin.
248973|NCT01395797|O2|Outcome|Pio Low Dose- Heroin|Participants will be maintained on 15 mg of PIO prior to assessing the abuse liability of heroin.
248974|NCT01395797|O1|Outcome|Placebo - Heroin|"Participants will be maintained on 0 mg of PIO prior to sessions assessing the abuse liability of heroin.~Placebo: Placebo"
248975|NCT01395797|O6|Outcome|Pio High Dose - Nicotine|"High dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
248976|NCT01395797|O5|Outcome|Pio Low Dose- Nicotine|Low dose Pio comparator.
248977|NCT01395797|O4|Outcome|Placebo - Nicotine|"Control condition for active arms.~Pioglitazone: 0, 15, and 45 mg per day."
248978|NCT01395797|O3|Outcome|Pio High Dose - Heroin|"High dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
248979|NCT01395797|O2|Outcome|Pio Low Dose- Heroin|Low dose of Pio comparator
248980|NCT01395797|O1|Outcome|Placebo - Heroin|"Control condition for active arms.~Placebo: Placebo - Heroin"
248981|NCT01395797|E6|Reported Event|Pio High Dose - Nicotine|"High dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
248982|NCT01395797|E5|Reported Event|Pio Low Dose - Nicotine|"Low dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
248983|NCT01395797|E4|Reported Event|Placebo - Nicotine|"Control condition for active arms.~Pioglitazone: 0, 15, and 45 mg per day."
248984|NCT01395797|E3|Reported Event|Pio High Dose - Heroin|"High dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
248985|NCT01395797|E2|Reported Event|Pio Low Dose - Heroin|"Low dose pio comparator.~Pioglitazone: 0, 15, and 45 mg per day."
248986|NCT01395797|E1|Reported Event|Placebo - Heroin|"Control condition for active arms.~Placebo: Placebo - Heroin"
248987|NCT01395784|B1|Baseline|Withing-subjects, Placebo-Controlled|Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.
248988|NCT01395784|P1|Participant Flow|Withing-subjects, Placebo-Controlled|"Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.~pioglitazone: A PPARγ agonist, also marketed as Actos."
248989|NCT01395784|O1|Outcome|All Participants|Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.
249091|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
248993|NCT01395758|B2|Baseline|Chemotherapy Arm|Investigator's choice of single agent chemotherapy (pemetrexed, docetaxel, or gemcitabine) administered in 3-week cycles according to the approved label until disease progression or unacceptable toxicity. Subjects who discontinued chemotherapy could be switched to the crossover arm (tivantinib plus erlotinib) and continue treatment until disease progression or unacceptable toxicity.
248994|NCT01395758|B1|Baseline|Tivantinib Plus Erlotinib Arm|Tivantinib 360 mg BID (total daily dose 720 mg) plus erlotinib 150 mg QD, tablets, orally in 3-week cycles until disease progression or unacceptable toxicity
248995|NCT01395758|P3|Participant Flow|Crossover Arm|"Following radiographically confirmed progression, subjects in the Chemotherapy Arm had the option to enroll in the Crossover Arm to receive tivantinib plus erlotinib.~Crossover subjects were treated with tivantinib 360 mg BID (total daily dose 720 mg) plus erlotinib 150 mg QD, tablets, orally in 3-week cycles until disease progression or unacceptable toxicity."
248996|NCT01395758|P2|Participant Flow|Chemotherapy Arm|Investigator's choice of single agent chemotherapy (pemetrexed, docetaxel, or gemcitabine) administered in 3-week cycles according to the approved label until disease progression or unacceptable toxicity. Subjects who discontinued chemotherapy could be switched to the Crossover Arm (tivantinib plus erlotinib) and continue treatment until disease progression or unacceptable toxicity.
248997|NCT01395758|P1|Participant Flow|Tivantinib Plus Erlotinib Arm|Tivantinib 360 mg twice daily (BID) (total daily dose 720 mg) plus erlotinib 150 mg once daily (QD), tablets, orally in 3-week cycles until disease progression or unacceptable toxicity
248998|NCT01395758|O1|Outcome|Tivantinib Plus Erlotinib Crossover Period|Following radiographically-confirmed progression, subjects randomly assigned to receive chemotherapy had the option to receive erlotinib plus tivantinib and were followed for post-progression objective response rate. Subjects who elected to crossover followed the Erlotinib plus Tivantinib Arm Schedule of Visits, following a post-chemotherapy 21-day washout period, until discontinuation criteria were met.
248999|NCT01395758|O2|Outcome|Chemotherapy Arm|Investigator's choice of single agent chemotherapy (pemetrexed, docetaxel, or gemcitabine) administered in 3-week cycles according to the approved label until disease progression or unacceptable toxicity. Subjects who discontinued chemotherapy could be switched to the crossover arm (tivantinib plus erlotinib) and continue treatment until disease progression or unacceptable toxicity.
249000|NCT01395758|O1|Outcome|Tivantinib Plus Erlotinib Arm|Tivantinib 360 mg BID (total daily dose 720 mg) plus erlotinib 150 mg QD, tablets, orally in 3-week cycles until disease progression or unacceptable toxicity
249001|NCT01395758|O2|Outcome|Chemotherapy Arm|Investigator's choice of single agent chemotherapy (pemetrexed, docetaxel, or gemcitabine) administered in 3-week cycles according to the approved label until disease progression or unacceptable toxicity. Subjects who discontinued chemotherapy could be switched to the crossover arm (tivantinib plus erlotinib) and continue treatment until disease progression or unacceptable toxicity.
249002|NCT01395758|O1|Outcome|Tivantinib Plus Erlotinib Arm|Tivantinib 360 mg BID (total daily dose 720 mg) plus erlotinib 150 mg QD, tablets, orally in 3-week cycles until disease progression or unacceptable toxicity
249003|NCT01395758|O2|Outcome|Chemotherapy Arm|Investigator's choice of single agent chemotherapy (pemetrexed, docetaxel, or gemcitabine) administered in 3-week cycles according to the approved label until disease progression or unacceptable toxicity. Subjects who discontinued chemotherapy could be switched to the crossover arm (tivantinib plus erlotinib) and continue treatment until disease progression or unacceptable toxicity.
249004|NCT01395758|O1|Outcome|Tivantinib Plus Erlotinib Arm|Tivantinib 360 mg BID (total daily dose 720 mg) plus erlotinib 150 mg QD, tablets, orally in 3-week cycles until disease progression or unacceptable toxicity
249005|NCT01395758|E2|Reported Event|Chemotherapy Arm|Investigator's choice of single agent chemotherapy (pemetrexed, docetaxel, or gemcitabine) administered in 3-week cycles according to the approved label until disease progression or unacceptable toxicity. Subjects who discontinued chemotherapy could be switched to the crossover arm (tivantinib plus erlotinib) and continue treatment until disease progression or unacceptable toxicity.
249006|NCT01395758|E1|Reported Event|Tivantinib Plus Erlotinib Arm|Tivantinib 360 mg BID (total daily dose 720 mg) plus erlotinib 150 mg QD, tablets, orally in 3-week cycles until disease progression or unacceptable toxicity
249007|NCT01395524|B4|Baseline|Total|Total of all reporting groups
249008|NCT01395524|B3|Baseline|Placebo|Placebo QD, oral treatment
249009|NCT01395524|B2|Baseline|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
249010|NCT01395524|B1|Baseline|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
249011|NCT01395524|P3|Participant Flow|Placebo|Placebo QD, oral treatment
249012|NCT01395524|P2|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
249013|NCT01395524|P1|Participant Flow|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
249014|NCT01395524|O3|Outcome|Placebo|Placebo QD, oral treatment
249015|NCT01395524|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
249016|NCT01395524|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
249017|NCT01395524|O3|Outcome|Placebo|Placebo QD, oral treatment
249018|NCT01395524|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
249019|NCT01395524|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
249020|NCT01395524|O3|Outcome|Placebo|Placebo QD, oral treatment
249021|NCT01395524|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
249022|NCT01395524|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
249023|NCT01395524|O3|Outcome|Placebo|Placebo QD, oral treatment
249024|NCT01395524|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
249025|NCT01395524|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
249026|NCT01395524|O3|Outcome|Placebo|Placebo QD, oral treatment
249027|NCT01395524|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
249028|NCT01395524|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
249029|NCT01395524|E3|Reported Event|Placebo|
249030|NCT01395524|E2|Reported Event|NKTR-118 25 mg|
249031|NCT01395524|E1|Reported Event|NKTR-118 12.5 mg|
249032|NCT01395394|B4|Baseline|Total|Total of all reporting groups
249092|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
249033|NCT01395394|B3|Baseline|BH4 Responders|"Participants in this group will use their already prescribed BH4 with the meal challenge and be assessed at a single study visit. They will take their prescribed BH4 with the meal.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
249034|NCT01395394|B2|Baseline|Healthy Controls|"Participants in this group match an enrolled PKU participant in terms of age, gender, and body mass index class. They will participate in a single study visit and will not be given BH4.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
249035|NCT01395394|B1|Baseline|BH4 Non-Responders|"Participants in this group have PKU and were deemed unresponsive to the drug. They will attend their first study visit, and proceed through the meal challenge without BH4. They will then take BH4 for 2 weeks. The second meal challenge will be performed with the participant's final dose of BH4.~Kuvan: Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
249036|NCT01395394|P3|Participant Flow|BH4 Responders|"Participants in this group will use their already prescribed BH4 with the meal challenge and be assessed at a single study visit. They will take their prescribed BH4 with the meal.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
249037|NCT01395394|P2|Participant Flow|Healthy Controls|"Participants in this group match an enrolled PKU participant in terms of age, gender, and body mass index class. They will participate in a single study visit and will not be given BH4.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
249038|NCT01395394|P1|Participant Flow|BH4 Non-Responders|"Participants in this group have PKU and were deemed unresponsive to the drug. They will attend their first study visit, and proceed through the meal challenge without BH4. They will then take BH4 for 2 weeks. The second meal challenge will be performed with the participant's final dose of BH4.~Kuvan: Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
249039|NCT01395394|O3|Outcome|BH4 Responders|"Participants in this group will use their already prescribed BH4 with the meal challenge and be assessed at a single study visit. They will take their prescribed BH4 with the meal.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
249040|NCT01395394|O2|Outcome|Healthy Controls|"Participants in this group match an enrolled PKU participant in terms of age, gender, and body mass index class. They will participate in a single study visit and will not be given BH4.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
249041|NCT01395394|O1|Outcome|BH4 Non-Responders|"Participants in this group have PKU and were deemed unresponsive to the drug. They will attend their first study visit, and proceed through the meal challenge without BH4. They will then take BH4 for 2 weeks. The second meal challenge will be performed with the participant's final dose of BH4.~Kuvan: Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
249042|NCT01395394|O3|Outcome|BH4 Responders|"Participants in this group will use their already prescribed BH4 with the meal challenge and be assessed at a single study visit. They will take their prescribed BH4 with the meal.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
249043|NCT01395394|O2|Outcome|Healthy Controls|"Participants in this group match an enrolled PKU participant in terms of age, gender, and body mass index class. They will participate in a single study visit and will not be given BH4.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
249044|NCT01395394|O1|Outcome|BH4 Non-Responders|"Participants in this group have PKU and were deemed unresponsive to the drug. They will attend their first study visit, and proceed through the meal challenge without BH4. They will then take BH4 for 2 weeks. The second meal challenge will be performed with the participant's final dose of BH4.~Kuvan: Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
249045|NCT01395394|E3|Reported Event|BH4 Responders|"Participants in this group will use their already prescribed BH4 with the meal challenge and be assessed at a single study visit. They will take their prescribed BH4 with the meal.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
249046|NCT01395394|E2|Reported Event|Healthy Controls|"Participants in this group match an enrolled PKU participant in terms of age, gender, and body mass index class. They will participate in a single study visit and will not be given BH4.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
249093|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
249094|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
249567|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
249047|NCT01395394|E1|Reported Event|BH4 Non-Responders|"Participants in this group have PKU and were deemed unresponsive to the drug. They will attend their first study visit, and proceed through the meal challenge without BH4. They will then take BH4 for 2 weeks. The second meal challenge will be performed with the participant's final dose of BH4.~Kuvan: Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
249048|NCT01395368|B1|Baseline|Tinnitus|Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month’s duration or longer.
249049|NCT01395368|P1|Participant Flow|Tinnitus|Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month’s duration or longer.
249050|NCT01395368|O1|Outcome|Tinnitus|Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or longer.
249051|NCT01395368|E1|Reported Event|Tinnitus|Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month’s duration or longer.
249052|NCT01395277|B3|Baseline|Total|Total of all reporting groups
249053|NCT01395277|B2|Baseline|Low Flavanol First Then High Flavanol|"The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with low flavanol content. On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with high flavanol content.~During the first visit the low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption."
249054|NCT01395277|B1|Baseline|High Flavanol First Then Low Flavanol|"The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with high flavanol content . On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with low flavanol content.~During the first visit the high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the placebo trial (low flavanol group) will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption."
249055|NCT01395277|P2|Participant Flow|Low Flavanol First Then High Flavanol|"The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with low flavanol content. On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with high flavanol content.~During the first visit the low flavanol measures will be performed before and 2 hours following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption."
249056|NCT01395277|P1|Participant Flow|High Flavanol First Then Low Flavanol|"The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with high flavanol content. On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with low flavanol content.~During the first visit the high flavanol measures will be performed before and 2 hours following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption."
249057|NCT01395277|O2|Outcome|Low Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with low flavanol content, and 2) before and 2 hours following consumption of a beverage with high flavanol content.~The low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The hihg flavanol measures will be performed following consumption of a beverage containing 1,0500 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
249058|NCT01395277|O1|Outcome|High Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with high flavanol content, and 2) before and 2 hours following consumption of a beverage with low flavanol content.~The high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
249095|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
249096|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
249097|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
249098|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
249099|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
249059|NCT01395277|O2|Outcome|Low Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with high flavanol content (experimental trial), and 2) before and 2 hours following consumption of a beverage with low flavanol content (placebo trial).~Placebo Trial: CocoaVia Dark Chocolate Flavored Drink: The placebo trial (low flavanol content) will be performed following consumption of a beverage containing 75 mg of Cocoa Flavanols. This cocoa flavanol powder will be purchased from Mars Incorporated (Hackettstown, New Jersey) and will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
249060|NCT01395277|O1|Outcome|High Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with high flavanol content (experimental trial), and 2) before and 2 hours following consumption of a beverage with low flavanol content (placebo trial).~CocoaVia Dark Chocolate Flavored Drink: The experimental trial (high flavanol group) will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols. This cocoa flavanol powder will be purchased from Mars Incorporated (Hackettstown, New Jersey) and will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
249061|NCT01395277|E2|Reported Event|Low Flavanol First Then High Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with low flavanol content, and 2) before and 2 hours following consumption of a beverage with high flavanol content.~The low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
249062|NCT01395277|E1|Reported Event|High Flavanol First Then Low Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with high flavanol content, and 2) before and 2 hours following consumption of a beverage with low flavanol content.~The high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
249063|NCT01395043|B1|Baseline|Bilateral Ultrasoundguide TAP-catheter|All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2.5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters
249064|NCT01395043|P1|Participant Flow|Bilateral Ultrasoundguide TAP-catheter|All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2.5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters
249065|NCT01395043|O1|Outcome|Bilateral Ultrasoundguide TAP-catheter|All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2.5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters.
249066|NCT01395043|O1|Outcome|Bilateral Ultrasoundguide TAP-catheter|All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2,5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters
249067|NCT01395043|E1|Reported Event|Bilateral Ultrasoundguide TAP-catheter|All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2.5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters
249068|NCT01395017|B3|Baseline|Total|Total of all reporting groups
249069|NCT01395017|B2|Baseline|Placebo + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
249070|NCT01395017|B1|Baseline|Dasatinib + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD.
249071|NCT01395017|P2|Participant Flow|Placebo + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
249072|NCT01395017|P1|Participant Flow|Dasatinib + GEM|GEM 1000 mg/m2 by intravenous (IV) infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth once daily (QD).
249073|NCT01395017|O2|Outcome|Placebo + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
249074|NCT01395017|O1|Outcome|Dasatinib + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD.
249075|NCT01395017|O2|Outcome|Placebo + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
249076|NCT01395017|O1|Outcome|Dasatinib + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD
249077|NCT01395017|E2|Reported Event|Placebo + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
249078|NCT01395017|E1|Reported Event|Dasatinib + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD
249079|NCT01394991|B3|Baseline|Total|Total of all reporting groups
249080|NCT01394991|B2|Baseline|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
249081|NCT01394991|B1|Baseline|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
249082|NCT01394991|P2|Participant Flow|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
249083|NCT01394991|P1|Participant Flow|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
249084|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
249085|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
249086|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
249087|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
249088|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
249089|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
249100|NCT01394991|E2|Reported Event|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
249101|NCT01394991|E1|Reported Event|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
249102|NCT01394978|B3|Baseline|Total|Total of all reporting groups
249103|NCT01394978|B2|Baseline|ProGEL Pleural Air Leak Sealant|"Standard surgical technique plus Progel Pleural Air Leak Sealant.~ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG)."
249104|NCT01394978|B1|Baseline|Control|"No treatment.~Control: Standard surgical techniques including staples and sutures."
249105|NCT01394978|P2|Participant Flow|ProGEL Pleural Air Leak Sealant|"Standard surgical technique plus Progel Pleural Air Leak Sealant.~ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG)."
249106|NCT01394978|P1|Participant Flow|Control|"No treatment.~Control: Standard surgical techniques including staples and sutures."
249107|NCT01394978|O2|Outcome|ProGEL Pleural Air Leak Sealant|"Standard surgical technique plus Progel Pleural Air Leak Sealant.~ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG)."
249108|NCT01394978|O1|Outcome|Control|"No treatment.~Control: Standard surgical techniques including staples and sutures."
249109|NCT01394978|E2|Reported Event|ProGEL Pleural Air Leak Sealant|"Standard surgical technique plus Progel Pleural Air Leak Sealant.~ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG)."
249110|NCT01394978|E1|Reported Event|Control|"No treatment.~Control: Standard surgical techniques including staples and sutures."
249111|NCT01394926|B1|Baseline|Optison|Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
249112|NCT01394926|P1|Participant Flow|Optison|Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
249113|NCT01394926|O3|Outcome|Dose Level 3: 1.5mL Optison 8 Minutes|Dose Level 3: Injection of 1.5mL of Optison 8 minutes post dose level 2.
249114|NCT01394926|O2|Outcome|Dose Level 2: 0.5mL Optison at Time 6.5 Minutes|Dose Level 2: Injection given of 0.5mL of Optison at 6.5 minutes post dose level 1.
249115|NCT01394926|O1|Outcome|Dose Level 1: Injection of 0.15mL Optison at Time 0.|Dose Level 1: Injection of 0.15mL Optison at time 0.
249116|NCT01394926|O3|Outcome|Dose Level 3: 1.5mL Optison 8 Minutes|Dose Level 3: Injection of 1.5mL of Optison 8 minutes post level 2.
249117|NCT01394926|O2|Outcome|Dose Level 2: 0.5mL of Optsion at Time 6.5 Minutes|Dose Level 2: Inj. of 0.5mL Optsion at time 6.5 minutes post dose level 1.
249118|NCT01394926|O1|Outcome|Dose Level 1: Injection of 0.15mL Optison at Time 0.|Dose Level 1 given as an Injection of 0.15mL of Optison at time 0.
249119|NCT01394926|E1|Reported Event|Optison|Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
249120|NCT01394718|B3|Baseline|Total|Total of all reporting groups
249121|NCT01394718|B2|Baseline|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
249122|NCT01394718|B1|Baseline|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
249123|NCT01394718|P2|Participant Flow|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
249124|NCT01394718|P1|Participant Flow|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
249125|NCT01394718|O2|Outcome|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
249126|NCT01394718|O1|Outcome|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
249158|NCT01394614|O2|Outcome|Unexposed Narcoleptic Subjects|Unexposed narcoleptic subjects (non-vaccinated or vaccinated after onset of symptoms)
249159|NCT01394614|O1|Outcome|Exposed Narcoleptic Subjects|"Exposed (vaccinated and onset of narcolepsy is post-vaccination) narcoleptic subjects~Intervention: Adjuvanted (ASO3) A/H1N1 pandemic vaccine Arepanrix."
249568|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
249127|NCT01394718|O2|Outcome|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
249128|NCT01394718|O1|Outcome|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
249129|NCT01394718|O2|Outcome|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
249130|NCT01394718|O1|Outcome|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
249131|NCT01394718|O2|Outcome|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
249132|NCT01394718|O1|Outcome|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
249133|NCT01394718|E2|Reported Event|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
249134|NCT01394718|E1|Reported Event|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
249135|NCT01394692|B3|Baseline|Total|Total of all reporting groups
249136|NCT01394692|B2|Baseline|Conventional Group|standard microsurgical tumor resection
249137|NCT01394692|B1|Baseline|Intraoperative MRI|tumor resection with intraoperative MRI-guidance
249138|NCT01394692|P2|Participant Flow|Conventional Group|standard microsurgical tumor resection
249139|NCT01394692|P1|Participant Flow|Intraoperative MRI|tumor resection with intraoperative MRI-guidance
249140|NCT01394692|O2|Outcome|Conventional Group|standard microsurgical tumor resection
249141|NCT01394692|O1|Outcome|Intraoperative MRI|tumor resection with intraoperative MRI-guidance
249142|NCT01394692|E2|Reported Event|Conventional Group|standard microsurgical tumor resection
249143|NCT01394692|E1|Reported Event|Intraoperative MRI|tumor resection with intraoperative MRI-guidance
249144|NCT01394627|B1|Baseline|All Participants|
249145|NCT01394627|P2|Participant Flow|Eplerenone (Period 1) /Washout (Period 2)/Placebo (Period 3)|"hypoglycemia of 50 mg/dl with 1 day of eplerenone (100 mg x 2) pretreatment~then after 1-3 month washout~hypoglycemia of 50 mg/dl with 1 day of placebo pretreatment"
249146|NCT01394627|P1|Participant Flow|Placebo (Period 1) /Washout (Period 2)/Eplerenone (Period 3)|"hypoglycemia of 50 mg/dl with 1 day of placebo pretreatment~then after 1-3 month washout~hypoglycemia of 50 mg/dl with 1 day of eplerenone (100 mg x 2) pretreatment"
249147|NCT01394627|O2|Outcome|Placebo|"hypoglycemia of 50 mg/dl plus placebo~Placebo"
249148|NCT01394627|O1|Outcome|Eplerenone|"hypoglycemia (50 mg/dl) with pretreatment with two doses of eplerenone (100 mg of eplerenone per dose)~Eplerenone: 100mg x 2"
249149|NCT01394627|O2|Outcome|Placebo|"hypoglycemia of 50 mg/dl plus placebo~Placebo"
249150|NCT01394627|O1|Outcome|Eplerenone|"hypoglycemia (50 mg/dl) with pretreatment with two doses of eplerenone (100 mg of eplerenone per dose)~Eplerenone: 100mg x 2"
249151|NCT01394627|E2|Reported Event|Placebo|hypoglycemia of 50 mg/dl plus placebo Placebo
249152|NCT01394627|E1|Reported Event|Eplerenone|hypoglycemia (50 mg/dl) with pretreatment with two doses of eplerenone (100 mg of eplerenone per dose) Eplerenone: 100mg x 2
249153|NCT01394614|B3|Baseline|Total|Total of all reporting groups
249154|NCT01394614|B2|Baseline|Unexposed Narcoleptic Subjects|Unexposed (non-vaccinated or vaccinated after onset of symptoms) narcoleptic subjects to adjuvanted A/H1N1 vaccine
249155|NCT01394614|B1|Baseline|Exposed Narcoleptic Subjects|Exposed (vaccinated and onset of narcolepsy is after vaccine administration) narcoleptic subjects to adjuvanted A/H1N1 vaccine
249156|NCT01394614|P2|Participant Flow|Unexposed Narcoleptic Subjects|Unexposed narcoleptic subjects (not vaccinated or vaccinated after the onset of symptoms)
249157|NCT01394614|P1|Participant Flow|Narcoleptic Subjects Exposed to Vaccine|Exposed narcoleptic subjects (vaccinated and onset of narcolepsy is after vaccine administration)
249160|NCT01394614|E2|Reported Event|Unexposed Narcoleptic Subjects|Unexposed narcoleptic subjects (non-vaccinated or vaccinated after onset of symptoms)
249161|NCT01394614|E1|Reported Event|Exposed Narcoleptic Subjects|"Exposed narcoleptic subjects (vaccinated and onset of narcolepsy is post-vaccination)~Intervention: Adjuvanted (ASO3) A/H1N1 pandemic vaccine (Arepanrix)"
249162|NCT01394523|B4|Baseline|Total|Total of all reporting groups
249163|NCT01394523|B3|Baseline|Local|"The surgeon will inject either 0.5% Bupivicaine 0.5ml/kg or 0.25% Bupivicaine 1ml/kg at the surgeon's discretion.~Bupivacaine: 0.25% or 0.5%"
249164|NCT01394523|B2|Baseline|Rectus Sheath|"The rectus sheath block will be performed with 0.1ml/kg of 0.25% Bupivacaine on each side at the T9-T10 distribution under ultrasound guidance.~Bupivacaine: 0.25% or 0.5%"
249165|NCT01394523|B1|Baseline|Caudal Epidural|"The caudal epidural block will be delivered with 1.5ml/kg of 0.25% Bupivacaine up to a maximum of 30 mL.~Bupivacaine: 0.25% or 0.5%"
249166|NCT01394523|P3|Participant Flow|Local|"The surgeon injected either 0.5% Bupivicaine 0.5ml/kg or 0.25% Bupivicaine 1ml/kg at the surgeon's discretion.~Bupivacaine: 0.25% or 0.5%"
249167|NCT01394523|P2|Participant Flow|Rectus Sheath|"The rectus sheath block was performed with 0.1ml/kg of 0.25% Bupivacaine on each side at the T9-T10 distribution under ultrasound guidance.~Bupivacaine: 0.25% or 0.5%"
249168|NCT01394523|P1|Participant Flow|Caudal Epidural|"The caudal epidural block was delivered with 1.5ml/kg of 0.25% Bupivacaine up to a maximum of 30 mL.~Bupivacaine: 0.25% or 0.5%"
249169|NCT01394523|O3|Outcome|Local|"The surgeon injected either 0.5% Bupivicaine 0.5ml/kg or 0.25% Bupivicaine 1ml/kg at the surgeon's discretion.~Bupivacaine: 0.25% or 0.5%"
249170|NCT01394523|O2|Outcome|Rectus Sheath|"The rectus sheath block was performed with 0.1ml/kg of 0.25% Bupivacaine on each side at the T9-T10 distribution under ultrasound guidance.~Bupivacaine: 0.25% or 0.5%"
249171|NCT01394523|O1|Outcome|Caudal Epidural|"The caudal epidural block was delivered with 1.5ml/kg of 0.25% Bupivacaine up to a maximum of 30 mL.~Bupivacaine: 0.25% or 0.5%"
249172|NCT01394523|E3|Reported Event|Local|"The surgeon will inject either 0.5% Bupivicaine 0.5ml/kg or 0.25% Bupivicaine 1ml/kg at the surgeon's discretion.~Bupivacaine: 0.25% or 0.5%"
249173|NCT01394523|E2|Reported Event|Rectus Sheath|"The rectus sheath block will be performed with 0.1ml/kg of 0.25% Bupivacaine on each side at the T9-T10 distribution under ultrasound guidance.~Bupivacaine: 0.25% or 0.5%"
249174|NCT01394523|E1|Reported Event|Caudal Epidural|"The caudal epidural block will be delivered with 1.5ml/kg of 0.25% Bupivacaine up to a maximum of 30 mL.~Bupivacaine: 0.25% or 0.5%"
249175|NCT01394510|B1|Baseline|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.~N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
249176|NCT01394510|P1|Participant Flow|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.~N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
249177|NCT01394510|O1|Outcome|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.~N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
249178|NCT01394510|O1|Outcome|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.~N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
249179|NCT01394510|O1|Outcome|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.~N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
249180|NCT01394510|E1|Reported Event|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.~N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
249181|NCT01394276|B1|Baseline|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
249182|NCT01394276|P1|Participant Flow|Tocilizumab|Participants with moderate to severe Rheumatoid arthritis (RA) who had received RoActemra [Tocilizumab (TCZ)] treatment for 6 months prior to initiation of study and are inadequate responders to Disease Modifying Anti-Rheumatic Drugs (DMARDs) and anti-Tumor Necrosis Factors (anti-TNFs) agents were observed. Participants received treatment with TCZ with dose of 8 milligrams per kilogram (mg/kg) body weight, intravenously once every 4 weeks for 12 months according to European Union (EU) approved dosage, and Summary of Product Characteristics (SmPC).
249183|NCT01394276|O2|Outcome|DMARD + Anti-TNF- IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
249184|NCT01394276|O1|Outcome|DMARD- IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
249206|NCT01394250|P2|Participant Flow|Topical Lidocaine 4% Cream|Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
249207|NCT01394250|P1|Participant Flow|Buzzy®|Buzzy® device was applied prior to intravenous cannulation.
249185|NCT01394276|O2|Outcome|DMARD + Anti-TNF- IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
249186|NCT01394276|O1|Outcome|DMARD- IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
249187|NCT01394276|O2|Outcome|DMARD + Anti-TNF-IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
249188|NCT01394276|O1|Outcome|DMARD-IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
249189|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
249190|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents. Participants receiving treatment with TCZ with dose of 8 milligrams mg/kg body weight, intravenously once every 4 weeks for 12 months were observed. Dosage of TCZ was prescribed according to EU approved dosage, and SmPC.
249191|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
249192|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
249193|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
249194|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
249195|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
249196|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
249197|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
249198|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
249199|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
249200|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
249201|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
249202|NCT01394276|E1|Reported Event|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
249203|NCT01394250|B3|Baseline|Total|Total of all reporting groups
249204|NCT01394250|B2|Baseline|Topical Lidocaine 4% Cream|Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
249205|NCT01394250|B1|Baseline|Buzzy®|Buzzy® device was applied prior to intravenous cannulation.
249208|NCT01394250|O2|Outcome|Topical Lidocaine 4% Cream|Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
249209|NCT01394250|O1|Outcome|Buzzy®|Buzzy® device was applied prior to intravenous cannulation.
249210|NCT01394250|O2|Outcome|Topical Lidocaine 4% Cream|Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
249211|NCT01394250|O1|Outcome|Buzzy®|Buzzy® device was applied prior to intravenous cannulation.
249212|NCT01394250|E2|Reported Event|Topical Lidocaine 4% Cream|Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
249213|NCT01394250|E1|Reported Event|Buzzy®|Buzzy® device was applied prior to intravenous cannulation.
249214|NCT01394185|B1|Baseline|All Participants|Participants received dronabinol (PL, 120mg, 240mg/day) in a randomized within-subject crossover design
249215|NCT01394185|P6|Participant Flow|Placebo, 240mg, 120mg|Participants received dronabinol for 12 days in the above order in a within-subject crossover
249216|NCT01394185|P5|Participant Flow|240mg, Placebo, 120mg|Participants received dronabinol for 12 days in the above order in a within-subject crossover
249217|NCT01394185|P4|Participant Flow|120mg, Placebo, 240mg|Participants received dronabinol for 12 days in the above order in a within-subject crossover
249218|NCT01394185|P3|Participant Flow|240mg, 120mg, Placebo|Participants received dronabinol for 12 days in the above order in a within-subject crossover
249219|NCT01394185|P2|Participant Flow|120mg, 240mg, Placebo|Participants received dronabinol for 12 days in the above order in a within-subject crossover
249220|NCT01394185|P1|Participant Flow|Placebo, 120mg, 240mg|Participants received dronabinol for 12 days in the above order in a within-subject crossover
249221|NCT01394185|O3|Outcome|240mg Dronabinol|240mg/day (80mg tid) dronabinol maintenance period
249222|NCT01394185|O2|Outcome|120mg Dronabinol|120mg/day (40mg tid) dronabinol maintenance period
249223|NCT01394185|O1|Outcome|Placebo|Placebo maintenance period
249224|NCT01394185|O3|Outcome|240mg Dronabinol|240mg/day (80mg tid) dronabinol maintenance period
249225|NCT01394185|O2|Outcome|120mg Dronabinol|120mg/day (40mg tid) dronabinol maintenance period
249226|NCT01394185|O1|Outcome|Placebo|Placebo maintenance period
249227|NCT01394185|E3|Reported Event|240mg Dronabinol|240mg (80mg tid) dronabinol maintenance
249228|NCT01394185|E2|Reported Event|120mg Dronabinol|120mg (40mg tid) dronabinol maintenance
249229|NCT01394185|E1|Reported Event|Placebo|Placebo dronabinol maintenance
249230|NCT01394159|B3|Baseline|Total|Total of all reporting groups
249231|NCT01394159|B2|Baseline|FNA Needle|FNA: Acquire tissue with FNA needle
249232|NCT01394159|B1|Baseline|ProCore Biopsy|"Acquire biopsy with procore needle~Procore Biopsy: Acquire tissue with procore biopsy needle"
249233|NCT01394159|P2|Participant Flow|22G FNA Needle|Acquire tissue with 22 gauge fine needle aspiration needle
249234|NCT01394159|P1|Participant Flow|22G ProCore Biopsy|"Acquire biopsy with procore needle~Procore Biopsy: Acquire tissue with procore biopsy needle"
249235|NCT01394159|O2|Outcome|22G FNA Needle|Acquire tissue with 22 gauge fine needle aspiration needle
249236|NCT01394159|O1|Outcome|22G ProCore Biopsy|"Acquire biopsy with procore needle~Procore Biopsy: Acquire tissue with procore biopsy needle"
249237|NCT01394159|O2|Outcome|22G FNA Needle|Acquire tissue with 22 gauge fine needle aspiration needle
249238|NCT01394159|O1|Outcome|22G ProCore Biopsy|"Acquire biopsy with procore needle~Procore Biopsy: Acquire tissue with procore biopsy needle"
249239|NCT01394159|O2|Outcome|22G FNA Needle|Acquire tissue with 22 gauge fine needle aspiration needle
249240|NCT01394159|O1|Outcome|22G ProCore Biopsy|"Acquire biopsy with procore needle~Procore Biopsy: Acquire tissue with procore biopsy needle"
249241|NCT01394159|E2|Reported Event|22G FNA Needle|Acquire tissue with 22 gauge fine needle aspiration needle
249242|NCT01394159|E1|Reported Event|22G ProCore Biopsy|"Acquire biopsy with procore needle~Procore Biopsy: Acquire tissue with procore biopsy needle"
249243|NCT01394081|B3|Baseline|Total|Total of all reporting groups
249244|NCT01394081|B2|Baseline|Administrative Outreach (AO)|The Administrative Outreach includes a VHA enrollment document package without education, patient navigation, or motivational interview. The usual procedures for the VA to enroll the veteran were then followed by VA staff not associated with the research study.
249245|NCT01394081|B1|Baseline|Enhanced Enrollment and Engagement (EEE)|The EEE intervention includes 1) an educational video about the services and mission of the VHA to mitigate possible negative beliefs about the VHA system of care; 2) a motivational interviewing component to address ambivalence and promote behavior change; and 3) a patient navigator model to help patients overcome systems barriers to enrolling and obtaining an initial appointment.
249246|NCT01394081|P2|Participant Flow|Administrative Outreach (AO)|The Administrative Outreach (AO) includes a VHA enrollment document package without education, patient navigation, or motivational interview. The usual procedures for the VA to enroll the veteran were then followed by VA staff not associated with the research study.
249247|NCT01394081|P1|Participant Flow|Enhanced Enrollment and Engagement (EEE)|The EEE intervention includes 1) an educational video about the services and mission of the VHA to mitigate possible negative beliefs about the VHA system of care; 2) a motivational interviewing component to address ambivalence and promote behavior change; and 3) a patient navigator model to help patients overcome systems barriers to enrolling and obtaining an initial appointment. This intervention was provided by a rural health outreach worker.
249248|NCT01394081|O2|Outcome|Administrative Outreach (AO)|Administrative Outreach (AO) includes a VHA enrollment document package without education, patient navigation, or motivational interview. The usual procedures for the VA to enroll the veteran were then followed by VA staff not associated with the research study.
249249|NCT01394081|O1|Outcome|Enhanced Enrollment and Engagement (EEE)|The EEE intervention includes 1) an educational video about the services and mission of the VHA to mitigate possible negative beliefs about the VHA system of care; 2) a motivational interviewing component to address ambivalence and promote behavior change; and 3) a patient navigator model to help patients overcome systems barriers to enrolling and obtaining an initial appointment.
249250|NCT01394081|O2|Outcome|Administrative Outreach (AO)|The Administrative Outreach includes a VHA enrollment document package without education, patient navigation, or motivational interview. The usual procedures for the VA to enroll the veteran were then followed by VA staff not associated with the research study.
249251|NCT01394081|O1|Outcome|Enhanced Enrollment and Engagement(EEE)|The EEE intervention includes 1) an educational video about the services and mission of the VHA to mitigate possible negative beliefs about the VHA system of care; 2) a motivational interviewing component to address ambivalence and promote behavior change; and 3) a patient navigator model to help patients overcome systems barriers to enrolling and obtaining an initial appointment.
249252|NCT01394081|E2|Reported Event|Administrative Outreach (AO)|Administrative Outreach (AO) includes a VHA enrollment document package without education, patient navigation, or motivational interview. The usual procedures for the VA to enroll the veteran were then followed by VA staff not associated with the research study.
249253|NCT01394081|E1|Reported Event|Enhanced Enrollment and Engagement (EEE)|Enhanced Enrollment and Engagement (EEE) intervention includes 1) an educational video about the services and mission of the VHA to mitigate possible negative beliefs about the VHA system of care; 2) a motivational interviewing component to address ambivalence and promote behavior change; and 3) a patient navigator model to help patients overcome systems barriers to enrolling and obtaining an initial appointment.
249254|NCT01393964|B4|Baseline|Total|Total of all reporting groups
249255|NCT01393964|B3|Baseline|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
249256|NCT01393964|B2|Baseline|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
249257|NCT01393964|B1|Baseline|Elotuzumab + LD in Normal Renal Function (NRF) Participants|Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
249258|NCT01393964|P3|Participant Flow|Elotuzumab + LD in End Stage Renal Disease(ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle(per product label). Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD = requires hemodialysis.
249259|NCT01393964|P2|Participant Flow|Elotuzumab + LD in Severe Renal Impairment(SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle(per product label). Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI = estimated CrCl < 30 ml/min but no dialysis.
249260|NCT01393964|P1|Participant Flow|Elotuzumab + LD in Normal Renal Function(NRF) Participants|Combination of lenalidomide and dexamethasone (LD). Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle (per product label). Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF = CrCl ≥ 90 milliliters per minute (mL/min).
249261|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
249332|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
249333|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
249262|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
249263|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
249264|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
249265|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
249266|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
249267|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
249268|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
249269|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
249334|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
249335|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
249270|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
249271|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
249272|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
249273|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
249274|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
249275|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
249276|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
249277|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
249336|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
249337|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
249338|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
249278|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
249279|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
249280|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
249281|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
249282|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
249283|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
249284|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
249285|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
249339|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
249340|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
249286|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
249287|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
249288|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
249289|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
249290|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
249291|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
249292|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
249293|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
249294|NCT01393964|E3|Reported Event|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
249341|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
249342|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
249295|NCT01393964|E2|Reported Event|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
249296|NCT01393964|E1|Reported Event|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
249297|NCT01393899|B4|Baseline|Total|Total of all reporting groups
249298|NCT01393899|B3|Baseline|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
249299|NCT01393899|B2|Baseline|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
249300|NCT01393899|B1|Baseline|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
249301|NCT01393899|P3|Participant Flow|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
249302|NCT01393899|P2|Participant Flow|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
249303|NCT01393899|P1|Participant Flow|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
249304|NCT01393899|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
249305|NCT01393899|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
249306|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
249307|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
249308|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
249309|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
249310|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
249311|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
249312|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
249313|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
249314|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
249315|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
249316|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
249317|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
249318|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
249319|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
249320|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
249321|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
249322|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
249323|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
249324|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
249325|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
249326|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
249327|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
249328|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
249329|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
249330|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
249331|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
249343|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
249344|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
249345|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
249346|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
249347|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
249348|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
249349|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
249350|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
249351|NCT01393899|E3|Reported Event|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
249352|NCT01393899|E2|Reported Event|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
249353|NCT01393899|E1|Reported Event|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
249354|NCT01393743|B3|Baseline|Total|Total of all reporting groups
249355|NCT01393743|B2|Baseline|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
249356|NCT01393743|B1|Baseline|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day, before bedtime and with food.
249357|NCT01393743|P3|Participant Flow|Perampanel (Extension Phase)|The Extension Phase consisted of two parts: Part A (6-week blinded Conversion Period plus a 32-week Maintenance Period) and Part B (maximum of 104-week Maintenance Period), which was followed by an additional 4-week Follow-up Period. Part A: Participants who were assigned to the perampanel arm in the Core Study continued to receive blinded perampanel once daily at the dose received during the Maintenance Period of the Core Study. During the Conversion Period, dose adjustments could be made at the investigator’s discretion. Part B: Participants were unblinded to study treatment and remained on the optimal perampanel dose established during the blinded Conversion Period (Part A). Dose adjustment in 2-mg increments (upwards or downwards) was allowed at the investigator's discretion. Participants who could not tolerate a dose of 2 mg/day perampanel during the Extension Period were discontinued from the study. The maximum dose of perampanel allowed during the Extension Phase was 12 mg/day.
249358|NCT01393743|P2|Participant Flow|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
249359|NCT01393743|P1|Participant Flow|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day, before bedtime and with food.
249360|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
249361|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day, before bedtime and with food.
249362|NCT01393743|O2|Outcome|All Seizures|The median percent change from the Pre-perampanel baseline in the seizure frequency per 28 days of all seizures by 13-week intervals through greater than or equal to Week 144.
249363|NCT01393743|O1|Outcome|PGTC Seizures|The median percent change from the Pre-perampanel baseline in PGTC seizure frequency per 28 days by 13-week intervals through greater than or equal to Week 144.
249364|NCT01393743|O1|Outcome|Perampanel (Extension Phase)|The Extension Phase consisted of two parts: Part A (6-week blinded Conversion Period plus a 32-week Maintenance Period) and Part B (maximum of 104-week Maintenance Period), which was followed by an additional 4-week Follow-up Period. Part A: Participants who were assigned to the perampanel arm in the Core Study continued to receive blinded perampanel once daily at the dose received during the Maintenance Period of the Core Study. During the Conversion Period, dose adjustments could be made at the investigator’s discretion. Part B: Participants were unblinded to study treatment and remained on the optimal perampanel dose established during the blinded Conversion Period (Part A). Dose adjustment in 2-mg increments (upwards or downwards) was allowed at the investigator's discretion. Participants who could not tolerate a dose of 2 mg/day perampanel during the Extension Period were discontinued from the study. The maximum dose of perampanel allowed during the Extension Phase was 12 mg/day.
249365|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
249366|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day, before bedtime and with food.
249367|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
249368|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day, before bedtime and with food.
249369|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
249370|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day, before bedtime and with food.
249371|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
249372|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day, before bedtime and with food.
249373|NCT01393743|O1|Outcome|Perampanel Extension Phase|The Extension Phase consisted of two parts: Part A (6-week blinded Conversion Period plus a 32-week Maintenance Period) and Part B (maximum of 104-week Maintenance Period), which was followed by an additional 4-week Follow-up Period. Part A: Participants who received placebo in the Core Study were started on blinded oral perampanel (2 mg/day) and were up-titrated weekly in 2-mg increments to the optimal dose per investigator's discretion, up to 12 mg/day perampanel maximum. Part B: Participants were unblinded to study treatment and remained on the optimal perampanel dose established during the blinded Conversion Period (Part A). Dose adjustment in 2-mg increments (upwards or downwards) was allowed at the investigator's discretion. Participants who could not tolerate a dose of 2 mg/day perampanel during the Extension Period were discontinued from the study. The maximum dose of perampanel allowed during the Extension Phase was 12 mg/day.
249374|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
249375|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day, before bedtime and with food.
249376|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
249377|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day, before bedtime and with food.
249378|NCT01393743|E3|Reported Event|Perampanel (Extension Phase)|The Extension Phase consisted of two parts: Part A (6-week blinded Conversion Period plus a 32-week Maintenance Period) and Part B (maximum of 104-week Maintenance Period), which was followed by an additional 4-week Follow-up Period. Part A: Participants who were assigned to the perampanel arm in the Core Study continued to receive blinded perampanel once daily at the dose received during the Maintenance Period of the Core Study. During the Conversion Period, dose adjustments could be made at the investigator’s discretion. Part B: Participants were unblinded to study treatment and remained on the optimal perampanel dose established during the blinded Conversion Period (Part A). Dose adjustment in 2-mg increments (upwards or downwards) was allowed at the investigator's discretion. Participants who could not tolerate a dose of 2 mg/day perampanel during the Extension Period were discontinued from the study. The maximum dose of perampanel allowed during the Extension Phase was 12 mg/day.
249379|NCT01393743|E2|Reported Event|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
249380|NCT01393743|E1|Reported Event|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day, before bedtime and with food.
249381|NCT01393730|B1|Baseline|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
249382|NCT01393730|P1|Participant Flow|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
249383|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
249384|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
249385|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
249386|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
249387|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
249388|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
249451|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks (N=85).
249569|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
249389|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
249390|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
249391|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
249392|NCT01393730|E1|Reported Event|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
249393|NCT01393717|B1|Baseline|All Study Participants|Patients receive salvage brentuximab vedotin IV.
249394|NCT01393717|P2|Participant Flow|Cohort #2|Patients receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
249395|NCT01393717|P1|Participant Flow|Cohort #1|Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses.
249396|NCT01393717|O1|Outcome|Patients Received BV Followed by AutoHCT|Patients that received brentuximab (BV) vedotin followed by autologous transplants
249397|NCT01393717|O1|Outcome|Patients With BV Followed by AutoHCT|Patients that received brentuximab vedotin followed by autologous transplants.
249398|NCT01393717|O2|Outcome|Cohort #2|Patients receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
249399|NCT01393717|O1|Outcome|Cohort #1|Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses.
249400|NCT01393717|O1|Outcome|Patients in Cohort #2|Patients receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
249401|NCT01393717|O1|Outcome|Patients in Cohort #2|Patients receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
249402|NCT01393717|O1|Outcome|Patients Receive Brentuximab Vedotin|Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses. Patients in the new cohort receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
249403|NCT01393717|O1|Outcome|Patients Receive Brentuximab Vedotin|Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses. Patients in the new cohort receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
249404|NCT01393717|E2|Reported Event|Cohort #2|Patients receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
249405|NCT01393717|E1|Reported Event|Cohort #1|Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses.
249406|NCT01393704|B3|Baseline|Total|Total of all reporting groups
249407|NCT01393704|B2|Baseline|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
249408|NCT01393704|B1|Baseline|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
249409|NCT01393704|P2|Participant Flow|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
249410|NCT01393704|P1|Participant Flow|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
249411|NCT01393704|O2|Outcome|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
249412|NCT01393704|O1|Outcome|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
249413|NCT01393704|O2|Outcome|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
249452|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks (N=90).
249414|NCT01393704|O1|Outcome|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
249415|NCT01393704|O2|Outcome|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
249416|NCT01393704|O1|Outcome|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
249417|NCT01393704|O2|Outcome|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
249418|NCT01393704|O1|Outcome|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
249419|NCT01393704|O2|Outcome|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
249420|NCT01393704|O1|Outcome|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
249421|NCT01393704|E2|Reported Event|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
249422|NCT01393704|E1|Reported Event|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
249423|NCT01393626|B5|Baseline|Total|Total of all reporting groups
249424|NCT01393626|B4|Baseline|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
249425|NCT01393626|B3|Baseline|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
249426|NCT01393626|B2|Baseline|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
249427|NCT01393626|B1|Baseline|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
249428|NCT01393626|P4|Participant Flow|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
249429|NCT01393626|P3|Participant Flow|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
249430|NCT01393626|P2|Participant Flow|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
249431|NCT01393626|P1|Participant Flow|Placebo|Placebo tablets to match tofacitinib 5 milligrams (mg) for oral administration twice daily (BID) for 8 weeks.
249432|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86).
249433|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks (N=85).
249434|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks (N=90).
249435|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks (N=16).
249436|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86).
249437|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks (N=85).
249438|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks (N=90).
249439|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86).
249440|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks (N=85).
249441|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks (N=90).
249442|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks (N=16).
249443|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86).
249444|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks (N=85).
249445|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks (N=90).
249446|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86).
249447|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks (N=85).
249448|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks (N=90).
249449|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks (N=16).
249450|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86).
249453|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
249454|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
249455|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
249456|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
249457|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
249458|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
249459|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
249460|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
249461|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
249462|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
249463|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
249464|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
249465|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86).
249466|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks (N=85).
249467|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks (N=90).
249468|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks (N=16).
249469|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86).
249470|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks (N=85).
249471|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks (N=90).
249472|NCT01393626|O3|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
249473|NCT01393626|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
249474|NCT01393626|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
249475|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
249476|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
249477|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
249478|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
249479|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
249480|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
249481|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
249482|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
249483|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
249484|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
249485|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
249486|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
249487|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
249488|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
249489|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
249490|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
249491|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
249492|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
249493|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
249494|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
249495|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
249496|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
249497|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
249498|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
249499|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
249500|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
249501|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
249502|NCT01393626|E4|Reported Event|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
249503|NCT01393626|E3|Reported Event|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
249504|NCT01393626|E2|Reported Event|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
249505|NCT01393626|E1|Reported Event|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
249506|NCT01393613|B5|Baseline|Total|Total of all reporting groups
249507|NCT01393613|B4|Baseline|Placebo|Placebo tablet once daily for 6 weeks.
249508|NCT01393613|B3|Baseline|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
249509|NCT01393613|B2|Baseline|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
249510|NCT01393613|B1|Baseline|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
249511|NCT01393613|P4|Participant Flow|Placebo|Placebo tablet once daily for 6 weeks.
249512|NCT01393613|P3|Participant Flow|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
249513|NCT01393613|P2|Participant Flow|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
249514|NCT01393613|P1|Participant Flow|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
249515|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
249516|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
249517|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
249518|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
249519|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks. Participants were titrated to the target dose of placebo over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
249520|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks. Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
249521|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
249522|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
249523|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
249524|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
249525|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
249526|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
249527|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
249528|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
249529|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
249530|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
249531|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
249532|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
249533|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
249534|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
249535|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
249536|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
249537|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
249538|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
249539|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
249540|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
249541|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
249542|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
249543|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
249544|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
249545|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
249546|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
249547|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
249548|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
249549|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
249550|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
249551|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
249552|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
249553|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
249554|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
249555|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
249556|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
249557|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
249558|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
249559|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
249560|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
249561|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
249562|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
249563|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
249564|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
249565|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
265249|NCT01344460|O2|Outcome|Unenhanced MRA|
249570|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
249571|NCT01393613|E4|Reported Event|Placebo|Placebo tablet once daily for 6 weeks.
249572|NCT01393613|E3|Reported Event|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
249573|NCT01393613|E2|Reported Event|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
249574|NCT01393613|E1|Reported Event|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
249575|NCT01393600|B1|Baseline|All Subjects|All randomized subjects who received at least one dose of study drug.
249576|NCT01393600|P4|Participant Flow|Valbenazine 50 mg, Then Placebo|Participants first received valbenazine 50 mg solution once daily from Day 1 to 14, then they received Placebo (matching valbenazine solution) once daily from Day 15 to 28.
249577|NCT01393600|P3|Participant Flow|Placebo, Then Valbenazine 50 mg|Participants first received Placebo (matching valbenazine solution) once daily from Day 1 to 14, then they received valbenazine 50 mg solution once daily from Day 15 to 28.
249578|NCT01393600|P2|Participant Flow|Valbenazine 12.5 mg, Then Placebo|Participants first received valbenazine 12.5 mg solution once daily from Day 1 to 14, then they received Placebo (matching valbenazine solution) once daily from Day 15 to 28.
249579|NCT01393600|P1|Participant Flow|Placebo, Then Valbenazine 12.5 mg|Participants first received Placebo (matching valbenazine solution) once daily from Day 1 to 14, then they received valbenazine 12.5 mg solution once daily from Day 15 to 28.
249580|NCT01393600|O3|Outcome|Valbenazine 50 mg|Valbenazine 50 mg solution
249581|NCT01393600|O2|Outcome|Valbenazine 12.5 mg|Valbenazine 12.5 mg solution
249582|NCT01393600|O1|Outcome|Placebo|Placebo (matching valbenazine solution)
249583|NCT01393600|O4|Outcome|Valbenazine 50mg|Participants who received valbenazine 50mg solution once daily from Day 1 to 14 and participants who received valbenazine 50mg solution from Day 15 to 28.
249584|NCT01393600|O3|Outcome|Valbenazine 50mg Placebo|Participants who received Placebo (matching valbenazine 50mg solution) once daily from Day 1 to 14 and participants who received Placebo (matching valbenazine 50mg solution) from Day 15 to 28.
249585|NCT01393600|O2|Outcome|Valbenazine 12.5mg|Participants who received valbenazine 12.5mg solution once daily from Day 1 to 14 and participants who received valbenazine 12.5mg solution from Day 15 to 28.
249586|NCT01393600|O1|Outcome|Valbenazine 12.5mg Placebo|Participants who received Placebo (matching valbenazine 12.5mg solution) once daily from Day 1 to 14 and participants who received Placebo (matching valbenazine 12.5mg solution) from Day 15 to 28.
249587|NCT01393600|O3|Outcome|Valbenazine 50 mg|Valbenazine 50 mg solution
249588|NCT01393600|O2|Outcome|Valbenazine 12.5 mg|Valbenazine 12.5 mg solution
249589|NCT01393600|O1|Outcome|Placebo|Placebo (matching valbenazine solution)
249590|NCT01393600|E3|Reported Event|NBI-98854 50 mg|NBI-98854 50 mg solution for 28 days followed by 7 days of posttreatment.
249591|NCT01393600|E2|Reported Event|NBI-98854 12.5 mg|NBI-98854 12.5 mg solution for 28 days followed by 7 days of posttreatment.
249592|NCT01393600|E1|Reported Event|Placebo|Placebo (matching NBI-98854 solution) for 28 days followed by 7 days of posttreatment.
249593|NCT01393457|B5|Baseline|Total|Total of all reporting groups
249594|NCT01393457|B4|Baseline|Placebo|Placebo
249595|NCT01393457|B3|Baseline|Ldopa|levodopa/carbidopa 800/200 mg/d
249596|NCT01393457|B2|Baseline|Ldopa + Ropinirole High Dose|"levodopa/carbidopa: 800/200 mg/d~Ropinirole 4 mg/d: 4 mg/d"
249597|NCT01393457|B1|Baseline|Ldopa + Ropinirole Low Dose|"levodopa/carbidopa: 800/200 mg/d~Ropinirole 2 mg/d: 2 mg/d"
249598|NCT01393457|P4|Participant Flow|Placebo|Placebo
249599|NCT01393457|P3|Participant Flow|Ldopa|levodopa/carbidopa 800/200 mg/d
249600|NCT01393457|P2|Participant Flow|Ldopa + Ropinirole High Dose|"levodopa/carbidopa: 800/200 mg/d~Ropinirole 4 mg/d: 4 mg/d"
249601|NCT01393457|P1|Participant Flow|Ldopa + Ropinirole Low Dose|"levodopa/carbidopa: 800/200 mg/d~Ropinirole 2 mg/d: 2 mg/d"
249602|NCT01393457|O4|Outcome|Placebo|Placebo
249603|NCT01393457|O3|Outcome|Ldopa|levodopa/carbidopa 800/200 mg/d
249604|NCT01393457|O2|Outcome|Ldopa + Ropinirole High Dose|"levodopa/carbidopa: 800/200 mg/d~Ropinirole 4 mg/d: 4 mg/d"
249605|NCT01393457|O1|Outcome|Ldopa + Ropinirole Low Dose|"levodopa/carbidopa: 800/200 mg/d~Ropinirole 2 mg/d: 2 mg/d"
249606|NCT01393457|O4|Outcome|Placebo|Placebo
249607|NCT01393457|O3|Outcome|Ldopa|levodopa/carbidopa 800/200 mg/d
249608|NCT01393457|O2|Outcome|Ldopa + Ropinirole High Dose|"levodopa/carbidopa: 800/200 mg/d~Ropinirole 4 mg/d: 4 mg/d"
249609|NCT01393457|O1|Outcome|Ldopa + Ropinirole Low Dose|"levodopa/carbidopa: 800/200 mg/d~Ropinirole 2 mg/d: 2 mg/d"
249610|NCT01393457|E4|Reported Event|Placebo|Placebo
249611|NCT01393457|E3|Reported Event|Ldopa|levodopa/carbidopa 800/200 mg/d
249612|NCT01393457|E2|Reported Event|Ldopa + Ropinirole High Dose|"levodopa/carbidopa: 800/200 mg/d~Ropinirole 4 mg/d: 4 mg/d"
249613|NCT01393457|E1|Reported Event|Ldopa + Ropinirole Low Dose|"levodopa/carbidopa: 800/200 mg/d~Ropinirole 2 mg/d: 2 mg/d"
249614|NCT01393444|B1|Baseline|Direct Brain Interface Users|"All participants enrolled in the study will undergo Implantation of ECoG sensors on the brain surface to record neural activity. There is no control group. There are no other arms.~Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants"
249615|NCT01393444|P1|Participant Flow|Direct Brain Interface Users|"All participants enrolled in the study will undergo Implantation of ECoG sensors on the brain surface to record neural activity. There is no control group. There are no other arms.~Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants"
249616|NCT01393444|O1|Outcome|Direct Brain Interface Users|"All participants enrolled in the study will undergo Implantation of ECoG sensors on the brain surface to record neural activity. There is no control group. There are no other arms.~Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants"
249645|NCT01393132|O2|Outcome|Placebo|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
255682|NCT01373450|O1|Outcome|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
249617|NCT01393444|O1|Outcome|Direct Brain Interface Users|"All participants enrolled in the study will undergo Implantation of ECoG sensors on the brain surface to record neural activity. There is no control group. There are no other arms.~Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants"
249618|NCT01393444|E1|Reported Event|Direct Brain Interface Users|"All participants enrolled in the study will undergo Implantation of ECoG sensors on the brain surface to record neural activity. There is no control group. There are no other arms.~Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants"
249619|NCT01393405|B1|Baseline|Induction Period (Week 1-16)|Steroid taper for 12 weeks and 25 mg MTX sq once weekly + 1 mg folic acid daily
249620|NCT01393405|P3|Participant Flow|Placebo Maintenance (Week 17-48)|Placebo sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine
249621|NCT01393405|P2|Participant Flow|Methotrexate Maintenance (Week 17-48)|25 mg MTX sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine
249622|NCT01393405|P1|Participant Flow|Induction Period (Week 1-16)|Steroid taper for 12 weeks and 25 mg MTX sq once weekly + 1 mg folic acid daily
249623|NCT01393405|O2|Outcome|Placebo Maintenance (Week 17-48)|Placebo sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine
249624|NCT01393405|O1|Outcome|Methotrexate Maintenance (Week 17-48)|25 mg MTX sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine
249625|NCT01393405|O1|Outcome|Induction Period (Week 1-16)|All patients treated with open label methotrexate 25 mg/kg bodyweight for 16 weeks in the Induction Period and a steroid taper week 0-12.
249626|NCT01393405|O2|Outcome|Placebo Maintenance (Week 17-48)|"Placebo sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine~Methotrexate: Induction period (week 1-16) (Open label):~25 mg MTX sq once weekly + Steroid taper + 1 mg folic acid daily~Maintenance period (week 17-48) (Randomization):~Placebo sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine"
249627|NCT01393405|O1|Outcome|Methotrexate Maintenance (Week 17-48)|"25 mg MTX sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine~Methotrexate: Induction period (week 1-16) (Open label):~25 mg MTX sq once weekly + Steroid taper + 1 mg folic acid daily~Maintenance period (week 17-48) (Randomization):~25 mg MTX sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine"
249628|NCT01393405|O1|Outcome|Induction Period (Week 1-16)|All patients treated with open label methotrexate 25 mg/kg bodyweight for 16 weeks in the Induction Period and a steroid taper week 0-12.
249629|NCT01393405|O2|Outcome|Placebo Maintenance (Week 17-48)|"Placebo sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine~Methotrexate: Induction period (week 1-16) (Open label):~25 mg MTX sq once weekly + Steroid taper + 1 mg folic acid daily~Maintenance period (week 17-48) (Randomization):~Placebo sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine"
249630|NCT01393405|O1|Outcome|Methotrexate Maintenance (Week 17-48)|"25 mg MTX sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine~Methotrexate: Induction period (week 1-16) (Open label):~25 mg MTX sq once weekly + Steroid taper + 1 mg folic acid daily~Maintenance period (week 17-48) (Randomization):~25 mg MTX sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine"
249631|NCT01393405|O2|Outcome|Placebo Maintenance (Week 17-48)|"Placebo sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine~Methotrexate: Induction period (week 1-16) (Open label):~25 mg MTX sq once weekly + Steroid taper + 1 mg folic acid daily~Maintenance period (week 17-48) (Randomization):~Placebo sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine"
249632|NCT01393405|O1|Outcome|Methotrexate Maintenance (Week 17-48)|"25 mg MTX sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine~Methotrexate: Induction period (week 1-16) (Open label):~25 mg MTX sq once weekly + Steroid taper + 1 mg folic acid daily~Maintenance period (week 17-48) (Randomization):~25 mg MTX sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine"
249633|NCT01393405|O2|Outcome|Placebo Maintenance (Week 17-48)|"Placebo sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine~Methotrexate: Induction period (week 1-16) (Open label):~25 mg MTX sq once weekly + Steroid taper + 1 mg folic acid daily~Maintenance period (week 17-48) (Randomization):~Placebo sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine"
249634|NCT01393405|O1|Outcome|Methotrexate Maintenance (Week 17-48)|"25 mg MTX sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine~Methotrexate: Induction period (week 1-16) (Open label):~25 mg MTX sq once weekly + Steroid taper + 1 mg folic acid daily~Maintenance period (week 17-48) (Randomization):~25 mg MTX sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine"
249635|NCT01393405|E3|Reported Event|Placebo Maintenance (Week 17-48)|Placebo sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine
249636|NCT01393405|E2|Reported Event|Methotrexate Maintenance (Week 17-48)|25 mg MTX sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine
249637|NCT01393405|E1|Reported Event|Induction Period (Week 1-16)|Steroid taper for 12 weeks and 25 mg MTX sq once weekly + 1 mg folic acid daily
249638|NCT01393132|B3|Baseline|Total|Total of all reporting groups
249639|NCT01393132|B2|Baseline|Placebo|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
249640|NCT01393132|B1|Baseline|Thymosin|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
249641|NCT01393132|P2|Participant Flow|Placebo|"Arm/Group * Reporting Groups Definition: Arms or comparison groups in a trial~Description Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days."
249642|NCT01393132|P1|Participant Flow|Thymosin|"Arm/Group * Reporting Groups Definition: Arms or comparison groups in a trial~Description Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days.~Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, six times daily for 28 days.~Period Title * Participant Flow: Overall Study~Placebo Thymosin Beta 4 Started 3 6 Completed 3 6"
249643|NCT01393132|O2|Outcome|Placebo|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
249644|NCT01393132|O1|Outcome|Thymosin|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
256539|NCT01370655|O1|Outcome|MK-7145 3 mg|Participants received 3 mg MK-7145 daily for 4 weeks
249646|NCT01393132|O1|Outcome|Thymosin|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
249647|NCT01393132|O2|Outcome|Placebo|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
249648|NCT01393132|O1|Outcome|Thymosin|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
249649|NCT01393132|O2|Outcome|Placebo|Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days
249650|NCT01393132|O1|Outcome|Thymosin|Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, six times daily for 28 days.
249651|NCT01393132|E2|Reported Event|Placebo|: A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days
249652|NCT01393132|E1|Reported Event|Thymosin Beta 4|Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, six times daily for 28 days.
249653|NCT01393106|B1|Baseline|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
249654|NCT01393106|P1|Participant Flow|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
249655|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
249656|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
249657|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
249658|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
249659|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
249660|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
249661|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
249662|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
249663|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
249664|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
249665|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
249666|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
249667|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
249668|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
249669|NCT01393106|E1|Reported Event|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
249670|NCT01392742|B1|Baseline|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
249671|NCT01392742|P1|Participant Flow|Hepatitis C Virus (HCV) Infected Participants|Participants who were infected by HCV and receiving pegylated interferon alfa-2a (PEG-IFN alfa-2a) 180 micrograms per week (µg/week) subcutaneously, plus ribavirin tablets 1000 milligrams (mg) (those weighing less than [<] 75 kilograms [kg]) or 1200 mg (those weighing greater than [>] 75 kg) orally; were observed for approximately up to 24 weeks after end of treatment (EOT). Dose change was as per investigators’ discretion.
249672|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
249673|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
249674|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
249675|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
249676|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
249677|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
249678|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
249679|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
249680|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
249681|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
249682|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
249683|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
249684|NCT01392742|E1|Reported Event|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately 24 weeks. Dose change was as per investigators’ discretion.
249685|NCT01392703|B1|Baseline|All Treated|
249686|NCT01392703|P3|Participant Flow|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
249687|NCT01392703|P2|Participant Flow|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
249688|NCT01392703|P1|Participant Flow|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
249689|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
249690|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
249691|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
249692|NCT01392703|O1|Outcome|All Treated|
249693|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
249694|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
249695|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
249696|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
249720|NCT01392677|O1|Outcome|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
256540|NCT01370655|E4|Reported Event|Placebo|Participants received Placebo MK-7145 daily for 4 weeks
249697|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
249698|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
249699|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
249700|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
249701|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
249702|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
249703|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period..
249704|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
249705|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
249706|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
249707|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
249708|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
249709|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
249710|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
249711|NCT01392703|E3|Reported Event|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
249712|NCT01392703|E2|Reported Event|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
249713|NCT01392703|E1|Reported Event|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
249714|NCT01392677|B3|Baseline|Total|Total of all reporting groups
249715|NCT01392677|B2|Baseline|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
249716|NCT01392677|B1|Baseline|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
249717|NCT01392677|P2|Participant Flow|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
249718|NCT01392677|P1|Participant Flow|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
249719|NCT01392677|O2|Outcome|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
256541|NCT01370655|E3|Reported Event|HCTZ 25 mg|Participants received HCTZ 25 mg daily for 4 weeks
249721|NCT01392677|O2|Outcome|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
249722|NCT01392677|O1|Outcome|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
249723|NCT01392677|O2|Outcome|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
249724|NCT01392677|O1|Outcome|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
249725|NCT01392677|O2|Outcome|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
249726|NCT01392677|O1|Outcome|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
249727|NCT01392677|O2|Outcome|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
249728|NCT01392677|O1|Outcome|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
249729|NCT01392677|E2|Reported Event|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
249730|NCT01392677|E1|Reported Event|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
249731|NCT01392625|B3|Baseline|Total|Total of all reporting groups
249732|NCT01392625|B2|Baseline|Allogeneic hMSCs|"Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.~Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:~Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
249733|NCT01392625|B1|Baseline|Autologous hMSCs|"Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.~Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:~Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
249734|NCT01392625|P2|Participant Flow|Allogeneic hMSCs|"Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.~Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:~Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
249735|NCT01392625|P1|Participant Flow|Autologous hMSCs|"Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.~Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:~Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
249736|NCT01392625|O2|Outcome|Allogeneic hMSCs|"Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.~Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:~Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
249737|NCT01392625|O1|Outcome|Autologous hMSCs|"Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.~Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:~Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
249738|NCT01392625|O2|Outcome|Allogeneic hMSCs|"Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.~Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:~Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
249739|NCT01392625|O1|Outcome|Autologous hMSCs|"Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.~Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:~Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
249740|NCT01392625|O2|Outcome|Allogeneic hMSCs|"Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.~Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:~Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
249741|NCT01392625|O1|Outcome|Autologous hMSCs|"Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.~Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:~Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
249742|NCT01392625|O2|Outcome|Allogeneic hMSCs|"Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.~Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:~Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
249743|NCT01392625|O1|Outcome|Autologous hMSCs|"Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.~Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:~Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
249744|NCT01392625|O2|Outcome|Allogeneic hMSCs|"Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.~Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:~Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
249745|NCT01392625|O1|Outcome|Autologous hMSCs|"Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.~Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:~Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
249746|NCT01392625|O2|Outcome|Allogeneic hMSCs|"Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.~Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:~Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
249747|NCT01392625|O1|Outcome|Autologous hMSCs|"Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.~Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:~Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
249748|NCT01392625|E2|Reported Event|Allogeneic hMSCs|"Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.~Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:~Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
249749|NCT01392625|E1|Reported Event|Autologous hMSCs|"Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.~Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:~Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
249750|NCT01392573|B3|Baseline|Total|Total of all reporting groups
249751|NCT01392573|B2|Baseline|IDeg|Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−5.0 mmol/L).
249752|NCT01392573|B1|Baseline|IDegLira|IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
249753|NCT01392573|P2|Participant Flow|IDeg|Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−5.0 mmol/L).
249779|NCT01392547|E2|Reported Event|rFVIIa 90 µg/kg|Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1−3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed
256542|NCT01370655|E2|Reported Event|MK-7145 6 mg|Participants received 6 mg MK-7145 for 4 weeks
249754|NCT01392573|P1|Participant Flow|IDegLira|Insulin degludec/liraglutide (IDegLira) was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast self-monitored plasma glucose (SMPG) values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
249755|NCT01392573|O2|Outcome|IDeg|Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−5.0 mmol/L).
249756|NCT01392573|O1|Outcome|IDegLira|IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
249757|NCT01392573|O2|Outcome|IDeg|Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−5.0 mmol/L).
249758|NCT01392573|O1|Outcome|IDegLira|IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
249759|NCT01392573|E2|Reported Event|IDeg|Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−5.0 mmol/L).
249760|NCT01392573|E1|Reported Event|IDegLira|IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
249761|NCT01392560|B1|Baseline|Empagliflozin (BI 10773) 25 mg|"Oral once daily~Empagliflozin 25 mg: Oral once daily"
249762|NCT01392560|P1|Participant Flow|Empagliflozin (BI 10773) 25 mg|"Oral once daily~Empagliflozin 25 mg: Oral once daily"
249763|NCT01392560|O3|Outcome|Non-hyperfilterers (Empagliflozin 25 mg)|"Non-hyperfilterers~Empagliflozin 25 mg: Oral once daily~non-hyperfilterers = GFRs of ≥60 mL/min/1.73m2 to <135 mL/min/1.73m2"
249764|NCT01392560|O2|Outcome|Hyperfilterers (Empagliflozin 25 mg)|"Hyperfilterers~Empagliflozin 25 mg: Oral once daily~hyperfilterers = GFRs of ≥135 mL/min/1.73m2"
249765|NCT01392560|O1|Outcome|All Patients (Empagliflozin 25 mg)|"All patients (hyperfilterers and non-hyperfilterers)~Empagliflozin 25 mg: Oral once daily"
249766|NCT01392560|E1|Reported Event|Empagliflozin 25 mg|"Oral once daily~Empagliflozin 25 mg: Oral once daily"
249767|NCT01392547|B1|Baseline|Vatrepcacog Alfa and rFVIIa|Subjects participating in the trial were randomised to receive vatreptacog alfa and rFVIIa in a cross-over manner.
249768|NCT01392547|P1|Participant Flow|Vatreptacog Alfa and rFVIIa (All Subjects)|Subjects participating in the trial were randomised to receive vatreptacog alfa and rFVIIa in a cross-over manner. Subjects participating in the trial had bleeding episodes randomised to treatment with either vatraptacog alfa or rFVIIa in an independent manner for each bleeding episodes. Of the 72 subjects, 3 subjects did not have any bleeds.
249769|NCT01392547|O2|Outcome|rFVIIa 90 µg/kg|Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1−3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed
249770|NCT01392547|O1|Outcome|Vatreptacog Alfa 80 µg/kg|Vatreptacog alfa was administered intravenous bolus, 1−3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed
249771|NCT01392547|O2|Outcome|rFVIIa 90 µg/kg|Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1−3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed
249772|NCT01392547|O1|Outcome|Vatreptacog Alfa 80 µg/kg|Vatreptacog alfa was administered intravenous bolus, 1−3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed
249773|NCT01392547|O2|Outcome|rFVIIa 90 µg/kg|Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1−3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed
249774|NCT01392547|O1|Outcome|Vatreptacog Alfa 80 µg/kg|Vatreptacog alfa was administered intravenous bolus, 1−3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed
249775|NCT01392547|O2|Outcome|rFVIIa 90 µg/kg|Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1−3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed
249776|NCT01392547|O1|Outcome|Vatreptacog Alfa 80 µg/kg|Vatreptacog alfa was administered intravenous bolus, 1−3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed
249777|NCT01392547|O2|Outcome|rFVIIa 90 µg/kg|Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1−3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed
249778|NCT01392547|O1|Outcome|Vatreptacog Alfa 80 µg/kg|Vatreptacog alfa was administered intravenous bolus, 1−3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed
256543|NCT01370655|E1|Reported Event|MK-7145 3 mg|Participants received 3 mg MK-7145 daily for 4 weeks
249780|NCT01392547|E1|Reported Event|Vatreptacog Alfa 80 µg/kg|Vatreptacog alfa was administered intravenous bolus, 1−3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed
249781|NCT01392495|B1|Baseline|QTI571|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
249782|NCT01392495|P1|Participant Flow|QTI571|Participants received 200 mg or 400 mg every day (qd) based on their highest tolerated dose in CQTI571A2102 (NCT01392469).
249783|NCT01392495|O2|Outcome|QTI571 400 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
249784|NCT01392495|O1|Outcome|QTI571 200 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
249785|NCT01392495|O2|Outcome|QTI571 400 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
249786|NCT01392495|O1|Outcome|QTI571 200 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
249787|NCT01392495|O2|Outcome|QTI571 400 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
249788|NCT01392495|O1|Outcome|QTI571 200 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
249789|NCT01392495|O2|Outcome|QTI571 400 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
249790|NCT01392495|O1|Outcome|QTI571 200 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
249791|NCT01392495|E2|Reported Event|QTI571 400mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
249792|NCT01392495|E1|Reported Event|QTI571 200mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
249793|NCT01392378|B6|Baseline|Total|Total of all reporting groups
249794|NCT01392378|B5|Baseline|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
249795|NCT01392378|B4|Baseline|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
249796|NCT01392378|B3|Baseline|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
249797|NCT01392378|B2|Baseline|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
249798|NCT01392378|B1|Baseline|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
249799|NCT01392378|P5|Participant Flow|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
249800|NCT01392378|P4|Participant Flow|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
249801|NCT01392378|P3|Participant Flow|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
249802|NCT01392378|P2|Participant Flow|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
249829|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
249803|NCT01392378|P1|Participant Flow|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
249804|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
249805|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
249806|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
249807|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
249808|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
249809|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
249810|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
249811|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
249812|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
249813|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
249814|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
249815|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
249869|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
249816|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
249817|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
249818|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
249819|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
249820|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
249821|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
249822|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
249823|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
249824|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
249825|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
249826|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
249827|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
249828|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
249997|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
249830|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
249831|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
249832|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
249833|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
249834|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
249835|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
249836|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
249837|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
249838|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
249839|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
249840|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
249841|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
249842|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
249998|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250414|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
249843|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
249844|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
249845|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
249846|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
249847|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
249848|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
249849|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
249850|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
249851|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
249852|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
249853|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
249854|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
249855|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
249909|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
249856|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
249857|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
249858|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
249859|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
249860|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
249861|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
249862|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
249863|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
249864|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
249865|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
249866|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
249867|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
249868|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
249992|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
249870|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
249871|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
249872|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
249873|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
249874|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
249875|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
249876|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
249877|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
249878|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
249879|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
249880|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
249881|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
249882|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
249993|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
251008|NCT01390389|O1|Outcome|Control|Healthy controls with no evidence of current or past psychiatric disorders.
249883|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
249884|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
249885|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
249886|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
249887|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
249888|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
249889|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
249890|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
249891|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
249892|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
249893|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
249894|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
249895|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
249994|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250107|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
249896|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
249897|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
249898|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
249899|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
249900|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
249901|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
249902|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
249903|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
249904|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
249905|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
249906|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
249907|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
249908|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
249995|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
249910|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
249911|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
249912|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
249913|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
249914|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
249915|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
249916|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
249917|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
249918|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
249919|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
249920|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
249921|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
249922|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
249996|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250205|NCT01391559|B1|Baseline|Entire Study Population|Includes groups randomized to receive Arformoterol first and Salmeterol first
249923|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
249924|NCT01392378|E15|Reported Event|13vPnC + INFANRIX Hexa - Toddler Dose|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 366 to 425 days of age, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
249925|NCT01392378|E14|Reported Event|13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -Toddler Dose|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 366 to 425 days of age, along with ibuprofen suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
249926|NCT01392378|E13|Reported Event|13vPnC +INFANRIX Hexa +Paracetamol Thrice Daily -Toddler Dose|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 366 to 425 days of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
249927|NCT01392378|E12|Reported Event|13vPnC +INFANRIX Hexa + Ibuprofen Twice Daily -Toddler Dose|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 366 to 425 days of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
249928|NCT01392378|E11|Reported Event|13vPnC +INFANRIX Hexa + Paracetamol Twice Daily -Toddler Dose|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 366 to 425 days of age, along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
249929|NCT01392378|E10|Reported Event|13vPnC + INFANRIX Hexa - After Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series, assessed after the infant series blood draw up to toddler dose.
249930|NCT01392378|E9|Reported Event|13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -After Inf Ser|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series (Inf Ser), along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed after the infant series blood draw up to toddler dose.
249931|NCT01392378|E8|Reported Event|13vPnC+INFANRIX Hexa +Paracetamol Thrice Daily -After Inf Ser|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series (Inf Ser), along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed after the infant series blood draw up to toddler dose.
249932|NCT01392378|E7|Reported Event|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -After Inf Ser|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series (Inf Ser), along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed after the infant series blood draw up to toddler dose.
249933|NCT01392378|E6|Reported Event|13vPnC +INFANRIX Hexa +Paracetamol Twice Daily -After Inf Ser|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series (Inf Ser), along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed after the infant series blood draw up to toddler dose.
249934|NCT01392378|E5|Reported Event|13vPnC + INFANRIX Hexa - Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series (Inf Ser).
249935|NCT01392378|E4|Reported Event|13vPnC+ INFANRIX Hexa+ Ibuprofen Thrice Daily -Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
249936|NCT01392378|E3|Reported Event|13vPnC+INFANRIX Hexa+Paracetamol Thrice Daily -Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
249937|NCT01392378|E2|Reported Event|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
249938|NCT01392378|E1|Reported Event|13vPnC+ INFANRIX Hexa +Paracetamol Twice Daily -Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series, along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
249939|NCT01392326|B4|Baseline|Total|Total of all reporting groups
249940|NCT01392326|B3|Baseline|Group 3|Placebo match (for 75 and 150 mg)
249941|NCT01392326|B2|Baseline|Group 2|Secukinumab (150 mg)
249942|NCT01392326|B1|Baseline|Group 1|Secukinumab (75mg)
249943|NCT01392326|P3|Participant Flow|Placebo Match for AIN457 ( 75 and 150 mg)|Placebo match (for 75 and 150 mg)
249944|NCT01392326|P2|Participant Flow|AIN457 (150 mg)|Secukinumab (150 mg)
249945|NCT01392326|P1|Participant Flow|AIN457 (75 mg)|Secukinumab (75mg)
249946|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
249947|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
249948|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
249949|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
249950|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
249951|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
249952|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
249953|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
249954|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
249955|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
249956|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
249957|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
249958|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
249959|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
249960|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
249961|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
249962|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
249963|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
249964|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
249965|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
249966|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
249967|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
249968|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
249969|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
249970|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
249971|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
249972|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
249973|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
249974|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
249975|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
249976|NCT01392326|E3|Reported Event|Placebo|Placebo. After week 24, only reponders continued to receive placebo to the end of the trial.
249977|NCT01392326|E2|Reported Event|Any AIN457 150 mg|Any AIN457 150 mg. After week 24 all placebo non responders were re-randomized to either 75 mg or 150 mg 1:1 to complete the trial
249978|NCT01392326|E1|Reported Event|Any AIN457 75 mg|Any AIN457 75 mg. After week 24 all placebo non responders were re-randomized to either 75 mg or 150 mg 1:1 to complete the trial
249979|NCT01392300|B3|Baseline|Total|Total of all reporting groups
249980|NCT01392300|B2|Baseline|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
249981|NCT01392300|B1|Baseline|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
249982|NCT01392300|P3|Participant Flow|OLEX IncobotulinumtoxinA (Xeomin) (400 Units, 3 Injections)|IncobotulinumtoxinA (Xeomin) (400 Units): OLEX period, three injection sessions - open-label treatment assignment
249983|NCT01392300|P2|Participant Flow|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
249984|NCT01392300|P1|Participant Flow|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
249985|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
249986|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
249987|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
249988|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
249989|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
249990|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
249991|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250286|NCT01391468|B3|Baseline|Total|Total of all reporting groups
249999|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250000|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250001|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250002|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250003|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250004|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250005|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250006|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250007|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250008|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250009|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250010|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250011|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250012|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250013|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250014|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250015|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250016|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250017|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250018|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250019|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250020|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250021|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250022|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250023|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250024|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250025|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250026|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250027|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250028|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250029|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250030|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250031|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250032|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250033|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250034|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250035|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250036|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250037|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250038|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250039|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250040|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250041|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250042|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250043|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250044|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250045|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250046|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250047|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250048|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250049|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250050|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250051|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250052|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250053|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250054|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250055|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250056|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250057|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250058|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250059|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250060|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250061|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250062|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250063|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250064|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250065|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250066|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250067|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250068|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250069|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250070|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250071|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250072|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250073|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250074|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250075|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250076|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250077|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250078|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250079|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250080|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250081|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250082|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250083|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250084|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250085|NCT01392300|E3|Reported Event|OLEX IncoboutulinumtoxinA (Xeomin) (400 Units, 3 Injections)|IncobotulinumtoxinA (Xeomin) (400 Units): OLEX period, three injection sessions - open-label treatment assignment
250086|NCT01392300|E2|Reported Event|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250087|NCT01392300|E1|Reported Event|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
250088|NCT01392170|B1|Baseline|PEG-IFNá-2a|PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
250089|NCT01392170|P1|Participant Flow|PEG-IFNá-2a|PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
250090|NCT01392170|O1|Outcome|PEG-IFNá-2a|PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
250091|NCT01392170|E1|Reported Event|PEG-IFNá-2a|PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
250092|NCT01392053|B3|Baseline|Total|Total of all reporting groups
250093|NCT01392053|B2|Baseline|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
250094|NCT01392053|B1|Baseline|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
250095|NCT01392053|P2|Participant Flow|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
250096|NCT01392053|P1|Participant Flow|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
250097|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
250098|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
250099|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
250100|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
250101|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
250102|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
250103|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
250104|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
250105|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
250106|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
250108|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
250109|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
250110|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
250111|NCT01392053|E2|Reported Event|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
250112|NCT01392053|E1|Reported Event|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
250113|NCT01391858|B3|Baseline|Total|Total of all reporting groups
250114|NCT01391858|B2|Baseline|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
250115|NCT01391858|B1|Baseline|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
250116|NCT01391858|P2|Participant Flow|Placebo|Placebo 1-2 hrs. before the surgery and then twice daily for 14 days
250117|NCT01391858|P1|Participant Flow|Pregabalin|Pregabalin 300 mg 1-2 hrs. before the surgery and then 150 mg twice a day for 14 days
250118|NCT01391858|O2|Outcome|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
250119|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
250120|NCT01391858|O2|Outcome|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
250121|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
250122|NCT01391858|O2|Outcome|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
250123|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
250124|NCT01391858|O2|Outcome|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
250125|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
250126|NCT01391858|O2|Outcome|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
250127|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
250128|NCT01391858|O2|Outcome|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
250129|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
250130|NCT01391858|O2|Outcome|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
250131|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
250132|NCT01391858|O2|Outcome|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
250133|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
250134|NCT01391858|E2|Reported Event|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
250135|NCT01391858|E1|Reported Event|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
250136|NCT01391819|B1|Baseline|Dengue Group|Subjects, male and female, aged 5-13 years, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
250137|NCT01391819|P1|Participant Flow|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
250138|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
250139|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
250140|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
250141|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
250142|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
250143|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
250144|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
250145|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
250146|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
250147|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
250148|NCT01391819|O2|Outcome|Dengue 10-17Y Group|Subjects, male and female, aged 10-17 years, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
250149|NCT01391819|O1|Outcome|Dengue 5-9Y Group|Subjects, male and female, aged 5-9 years, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
250150|NCT01391819|O2|Outcome|Dengue 10-17Y Group|Subjects, male and female, aged 10-17 years, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
250151|NCT01391819|O1|Outcome|Dengue 5-9Y Group|Subjects, male and female, aged 5-9 years, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
250152|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
250153|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
256544|NCT01370642|B4|Baseline|Total|Total of all reporting groups
250154|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
250155|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
250156|NCT01391819|O2|Outcome|Dengue 10-17Y Group|Subjects, male and female, aged 10-17 years (Y), enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
250157|NCT01391819|O1|Outcome|Dengue 5-9Y Group|Subjects, male and female, aged 5-9 years (Y), enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
250158|NCT01391819|O2|Outcome|Dengue 10-17Y Group|Subjects, male and female, aged 10-17 years (Y), enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
250159|NCT01391819|O1|Outcome|Dengue 5-9Y Group|Subjects, male and female, aged 5-9 years (Y), enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
250160|NCT01391819|O2|Outcome|Dengue 10-17Y Group|Subjects, male and female, aged 10-17 years (Y), enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
250161|NCT01391819|O1|Outcome|Dengue 5-9Y Group|Subjects, male and female, aged 5-9 years (Y), enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
250162|NCT01391819|E1|Reported Event|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
250163|NCT01391663|B5|Baseline|Total|Total of all reporting groups
250164|NCT01391663|B4|Baseline|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
250165|NCT01391663|B3|Baseline|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
250166|NCT01391663|B2|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
250167|NCT01391663|B1|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
250168|NCT01391663|P4|Participant Flow|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
250169|NCT01391663|P3|Participant Flow|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
250170|NCT01391663|P2|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
250171|NCT01391663|P1|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
250172|NCT01391663|O4|Outcome|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
250173|NCT01391663|O3|Outcome|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
250174|NCT01391663|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
250175|NCT01391663|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
250176|NCT01391663|O4|Outcome|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
250177|NCT01391663|O3|Outcome|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
250178|NCT01391663|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
250179|NCT01391663|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
250180|NCT01391663|O4|Outcome|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
250181|NCT01391663|O3|Outcome|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
250182|NCT01391663|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
250183|NCT01391663|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
250184|NCT01391663|O4|Outcome|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
250185|NCT01391663|O3|Outcome|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
250186|NCT01391663|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
250187|NCT01391663|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
250188|NCT01391663|O4|Outcome|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
250189|NCT01391663|O3|Outcome|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
250190|NCT01391663|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
250191|NCT01391663|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
250192|NCT01391663|O4|Outcome|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
250193|NCT01391663|O3|Outcome|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
250194|NCT01391663|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
250195|NCT01391663|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
250196|NCT01391663|E4|Reported Event|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
250197|NCT01391663|E3|Reported Event|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
250198|NCT01391663|E2|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
250199|NCT01391663|E1|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
250200|NCT01391611|B1|Baseline|Pazopanib Arm|Pazopanib: 800 mg; PO
250201|NCT01391611|P1|Participant Flow|Pazopanib Arm|Pazopanib: 800 mg; PO
250202|NCT01391611|O1|Outcome|Pazopanib Arm|Pazopanib: 800 mg; PO
250203|NCT01391611|O1|Outcome|Pazopanib Arm|Pazopanib: 800 mg; PO
250204|NCT01391611|E1|Reported Event|Pazopanib Arm|Pazopanib: 800 mg; PO
256971|NCT01369745|E2|Reported Event|Dipyridamole|dipyridamole 360 mg once daily
250206|NCT01391559|P2|Participant Flow|Salmeterol First, Then Arformoterol|Salmeterol (50 mcg) Diskus in the first intervention, Arformoterol (15 mcg/2 mL) solution via nebulizer in the second intervention
250207|NCT01391559|P1|Participant Flow|Arformoterol First, Then Salmeterol|Arformoterol (15 mcg/2 mL) solution via nebulizer in the first intervention, Salmeterol (50 mcg) Diskus in the second intervention
250208|NCT01391559|O2|Outcome|Salmeterol|Salmeterol dry powder (50 mcg) via Diskus
250209|NCT01391559|O1|Outcome|Arformoterol|Arformoterol aerosol solution (15 mcg/2 mL)via nebulizer
250210|NCT01391559|E2|Reported Event|Salmeterol|Salmeterol dry powder (50 mcg) via Diskus
250211|NCT01391559|E1|Reported Event|Arformoterol|Arformoterol aerosol solution (15 mcg/2 mL)via nebulizer
250212|NCT01391546|B3|Baseline|Total|Total of all reporting groups
250213|NCT01391546|B2|Baseline|ZOSTAVAX Subcutaneous (SC) Route|Single dose of 0.65 mL via SC injection
250214|NCT01391546|B1|Baseline|ZOSTAVAX Intramuscular (IM) Route|Single dose of 0.65 mL via IM injection
250215|NCT01391546|P2|Participant Flow|ZOSTAVAX Subcutaneous (SC) Route|Single dose of 0.65 mL via SC injection
250216|NCT01391546|P1|Participant Flow|ZOSTAVAX Intramuscular (IM) Route|Single dose of 0.65 mL via IM injection
250217|NCT01391546|O2|Outcome|ZOSTAVAX Subcutaneous (SC) Route|Single dose of 0.65 mL via SC injection
250218|NCT01391546|O1|Outcome|ZOSTAVAX Intramuscular (IM) Route|Single dose of 0.65 mL via IM injection
250219|NCT01391546|O2|Outcome|ZOSTAVAX Subcutaneous (SC) Route|Single dose of 0.65 mL via SC injection
250220|NCT01391546|O1|Outcome|ZOSTAVAX Intramuscular (IM) Route|Single dose of 0.65 mL via IM injection
250221|NCT01391546|O2|Outcome|ZOSTAVAX Subcutaneous (SC) Route|Single dose of 0.65 mL via SC injection
250222|NCT01391546|O1|Outcome|ZOSTAVAX Intramuscular (IM) Route|Single dose of 0.65 mL via IM injection
250223|NCT01391546|O2|Outcome|ZOSTAVAX Subcutaneous (SC) Route|Single dose of 0.65 mL via SC injection
250224|NCT01391546|O1|Outcome|ZOSTAVAX Intramuscular (IM) Route|Single dose of 0.65 mL via IM injection
250225|NCT01391546|O2|Outcome|ZOSTAVAX Subcutaneous (SC) Route|Single dose of 0.65 mL via SC injection
250226|NCT01391546|O1|Outcome|ZOSTAVAX Intramuscular (IM) Route|Single dose of 0.65 mL via IM injection
250227|NCT01391546|O1|Outcome|ZOSTAVAX Subcutaneous (SC) Route|Single dose of 0.65 mL via SC injection
250228|NCT01391546|O1|Outcome|ZOSTAVAX Intramuscular (IM) Route|Single dose of 0.65 mL via IM injection
250229|NCT01391546|O2|Outcome|ZOSTAVAX Subcutaneous (SC) Route|Single dose of 0.65 mL via SC injection
250230|NCT01391546|O1|Outcome|ZOSTAVAX Intramuscular (IM) Route|Single dose of 0.65 mL via IM injection
250231|NCT01391546|E2|Reported Event|ZOSTAVAX Subcutaneous (SC) Route|Single dose of 0.65 mL via SC injection
250232|NCT01391546|E1|Reported Event|ZOSTAVAX Intramuscular (IM) Route|Single dose of 0.65 mL via IM injection
250233|NCT01391507|B5|Baseline|Total|Total of all reporting groups
250234|NCT01391507|B4|Baseline|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250235|NCT01391507|B3|Baseline|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250236|NCT01391507|B2|Baseline|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250237|NCT01391507|B1|Baseline|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250238|NCT01391507|P4|Participant Flow|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250239|NCT01391507|P3|Participant Flow|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250240|NCT01391507|P2|Participant Flow|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250241|NCT01391507|P1|Participant Flow|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250242|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250243|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250244|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250245|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250246|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250247|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250248|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250249|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250250|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250251|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250252|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250253|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250254|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250255|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250256|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250257|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250258|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250259|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250260|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250261|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250262|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250263|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250264|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250265|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250266|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250267|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250268|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250269|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250270|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250271|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250272|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250273|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250274|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250275|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250276|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250277|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250278|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250279|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250280|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250281|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250282|NCT01391507|E4|Reported Event|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250283|NCT01391507|E3|Reported Event|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250284|NCT01391507|E2|Reported Event|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250285|NCT01391507|E1|Reported Event|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
250287|NCT01391468|B2|Baseline|Probiotics|Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
250288|NCT01391468|B1|Baseline|Placebo|Cornstarch: placebo will be given in 6 months
250289|NCT01391468|P2|Participant Flow|Probiotics|Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
250290|NCT01391468|P1|Participant Flow|Placebo|Cornstarch: placebo will be given in 6 months
250291|NCT01391468|O2|Outcome|Placebo|Plabeco group received maltodextrin for 6 months
250292|NCT01391468|O1|Outcome|Probiotics|"probiotics~Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations"
250293|NCT01391468|O2|Outcome|Placebo|Placeo group received maltodextrin for 6 months
250294|NCT01391468|O1|Outcome|Probiotics|"probiotics~Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations"
250295|NCT01391468|O2|Outcome|Probiotics|"probiotics~Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations"
250296|NCT01391468|O1|Outcome|Placebo|"cornstarch~Cornstarch: placebo will be given in 6 months"
250297|NCT01391468|O2|Outcome|Probiotics|Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
250298|NCT01391468|O1|Outcome|Placebo|Cornstarch: placebo will be given in 6 months
250299|NCT01391468|E2|Reported Event|Placebo|Cornstarch: placebo will be given in 6 months
250300|NCT01391468|E1|Reported Event|Probiotics|Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
250301|NCT01391325|B1|Baseline|Allopurinol|"Treatment.~Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
250302|NCT01391325|P1|Participant Flow|Allopurinol|"Treatment.~Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
250303|NCT01391325|O1|Outcome|Allopurinol|"Treatment.~Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
250304|NCT01391325|O1|Outcome|Allopurinol|"Treatment.~Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
250305|NCT01391325|O1|Outcome|Allopurinol|"Treatment.~Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
250306|NCT01391325|O1|Outcome|Allopurinol|"Treatment.~Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
250307|NCT01391325|E1|Reported Event|Allopurinol|"Treatment.~Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
250308|NCT01391312|B3|Baseline|Total|Total of all reporting groups
250309|NCT01391312|B2|Baseline|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
250310|NCT01391312|B1|Baseline|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
250311|NCT01391312|P2|Participant Flow|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
250312|NCT01391312|P1|Participant Flow|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
250313|NCT01391312|O2|Outcome|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
250314|NCT01391312|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
250315|NCT01391312|O2|Outcome|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
250316|NCT01391312|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
250317|NCT01391312|O2|Outcome|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
250318|NCT01391312|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
250319|NCT01391312|E2|Reported Event|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
250320|NCT01391312|E1|Reported Event|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
250321|NCT01391299|B4|Baseline|Total|Total of all reporting groups
250322|NCT01391299|B3|Baseline|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
250323|NCT01391299|B2|Baseline|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
250324|NCT01391299|B1|Baseline|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
250325|NCT01391299|P3|Participant Flow|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
250326|NCT01391299|P2|Participant Flow|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
250327|NCT01391299|P1|Participant Flow|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
250328|NCT01391299|O3|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
250329|NCT01391299|O2|Outcome|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
250330|NCT01391299|O1|Outcome|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
265250|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
250331|NCT01391299|O3|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
250332|NCT01391299|O2|Outcome|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
250333|NCT01391299|O1|Outcome|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
250334|NCT01391299|O3|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
250335|NCT01391299|O2|Outcome|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
250336|NCT01391299|O1|Outcome|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
250337|NCT01391299|O3|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
250338|NCT01391299|O2|Outcome|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
250339|NCT01391299|O1|Outcome|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
250340|NCT01391299|O3|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
250341|NCT01391299|O2|Outcome|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
250342|NCT01391299|O1|Outcome|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
250343|NCT01391299|E3|Reported Event|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
250344|NCT01391299|E2|Reported Event|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
250345|NCT01391299|E1|Reported Event|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
250346|NCT01391286|B3|Baseline|Total|Total of all reporting groups
250347|NCT01391286|B2|Baseline|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
250348|NCT01391286|B1|Baseline|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
250349|NCT01391286|P2|Participant Flow|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
250350|NCT01391286|P1|Participant Flow|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
250351|NCT01391286|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
250352|NCT01391286|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
250353|NCT01391286|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
250354|NCT01391286|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
250355|NCT01391286|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
250356|NCT01391286|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
250357|NCT01391286|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
250358|NCT01391286|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
250359|NCT01391286|E2|Reported Event|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
250360|NCT01391286|E1|Reported Event|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
250361|NCT01391273|B3|Baseline|Total|Total of all reporting groups
250362|NCT01391273|B2|Baseline|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
250363|NCT01391273|B1|Baseline|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
250364|NCT01391273|P2|Participant Flow|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
250365|NCT01391273|P1|Participant Flow|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
250366|NCT01391273|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
250367|NCT01391273|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
250368|NCT01391273|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
250369|NCT01391273|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
250370|NCT01391273|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
250371|NCT01391273|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
250372|NCT01391273|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
250373|NCT01391273|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
250374|NCT01391273|E2|Reported Event|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
250375|NCT01391273|E1|Reported Event|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
250376|NCT01391013|B3|Baseline|Total|Total of all reporting groups
250377|NCT01391013|B2|Baseline|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
250378|NCT01391013|B1|Baseline|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
250379|NCT01391013|P2|Participant Flow|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
250380|NCT01391013|P1|Participant Flow|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
250381|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
250382|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
250383|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
250384|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
250385|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
250386|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
250387|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
250388|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
250389|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
250390|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
250391|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
250392|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
250393|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
250394|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
250395|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
250396|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
250397|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
250398|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
250399|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
250400|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
250401|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
250402|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
250403|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
250404|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
250405|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
250406|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
250407|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
250408|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
250409|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
250410|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
250411|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
250412|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
250413|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
250415|NCT01391013|E2|Reported Event|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
250416|NCT01391013|E1|Reported Event|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
250417|NCT01391000|B3|Baseline|Total|Total of all reporting groups
250418|NCT01391000|B2|Baseline|TENS|"TENS: Transcutaneous Electrical Nerve Application of Stimulation occurs through the use of No. 3 channels (long head of biceps area (CLB), the supraspinatus muscle area, the area medial border of the scapula.~Duration: Twenty (20) minutes, mpulsi: 70 microsec, frequency: 100 Hz, intensity: between 20 and 40 mA."
250419|NCT01391000|B1|Baseline|Laser CO2|LASER CO2: The therapy is performed with the patient sitting, place the unit high above the shoulder with the following indicators: through a pulsed 40 Hz, distance between device and patient 60 cm, 10x15 cm area of application, power 2W; energy between 10 and 15 J/cm2
250420|NCT01391000|P2|Participant Flow|TENS|"TENS: Transcutaneous Electrical Nerve Application of Stimulation occurs through the use of No. 3 channels (long head of biceps area (CLB), the supraspinatus muscle area, the area medial border of the scapula.~Duration: Twenty (20) minutes, mpulsi: 70 microsec, frequency: 100 Hz, intensity: between 20 and 40 mA."
250421|NCT01391000|P1|Participant Flow|Laser CO2|LASER CO2: The therapy is performed with the patient sitting, place the unit high above the shoulder with the following indicators: through a pulsed 40 Hz, distance between device and patient 60 cm, 10x15 cm area of application, power 2W; energy between 10 and 15 J/cm2
250422|NCT01391000|O2|Outcome|TENS|"TENS: Transcutaneous Electrical Nerve Application of Stimulation occurs through the use of No. 3 channels (long head of biceps area (CLB), the supraspinatus muscle area, the area medial border of the scapula.~Duration: Twenty (20) minutes, mpulsi: 70 microsec, frequency: 100 Hz, intensity: between 20 and 40 mA."
250423|NCT01391000|O1|Outcome|Laser CO2|LASER CO2: The therapy is performed with the patient sitting, place the unit high above the shoulder with the following indicators: through a pulsed 40 Hz, distance between device and patient 60 cm, 10x15 cm area of application, power 2W; energy between 10 and 15 J/cm2
250424|NCT01391000|O2|Outcome|TENS|"TENS: Transcutaneous Electrical Nerve Application of Stimulation occurs through the use of No. 3 channels (long head of biceps area (CLB), the supraspinatus muscle area, the area medial border of the scapula.~Duration: Twenty (20) minutes, mpulsi: 70 microsec, frequency: 100 Hz, intensity: between 20 and 40 mA."
250425|NCT01391000|O1|Outcome|Laser CO2|LASER CO2: The therapy is performed with the patient sitting, place the unit high above the shoulder with the following indicators: through a pulsed 40 Hz, distance between device and patient 60 cm, 10x15 cm area of application, power 2W; energy between 10 and 15 J/cm2
250426|NCT01391000|O2|Outcome|TENS|"TENS: Transcutaneous Electrical Nerve Application of Stimulation occurs through the use of No. 3 channels (long head of biceps area (CLB), the supraspinatus muscle area, the area medial border of the scapula.~Duration: Twenty (20) minutes, mpulsi: 70 microsec, frequency: 100 Hz, intensity: between 20 and 40 mA."
250427|NCT01391000|O1|Outcome|Laser CO2|LASER CO2: The therapy is performed with the patient sitting, place the unit high above the shoulder with the following indicators: through a pulsed 40 Hz, distance between device and patient 60 cm, 10x15 cm area of application, power 2W; energy between 10 and 15 J/cm2
250428|NCT01391000|E2|Reported Event|TENS|"TENS: Transcutaneous Electrical Nerve Application of Stimulation occurs through the use of No. 3 channels (long head of biceps area (CLB), the supraspinatus muscle area, the area medial border of the scapula.~Duration: Twenty (20) minutes, mpulsi: 70 microsec, frequency: 100 Hz, intensity: between 20 and 40 mA."
250429|NCT01391000|E1|Reported Event|Laser CO2|LASER CO2: The therapy is performed with the patient sitting, place the unit high above the shoulder with the following indicators: through a pulsed 40 Hz, distance between device and patient 60 cm, 10x15 cm area of application, power 2W; energy between 10 and 15 J/cm2
250430|NCT01390948|B4|Baseline|Total|Total of all reporting groups
250431|NCT01390948|B3|Baseline|Bevacizumab + TMZ Young Patient Cohort (YPC)|Participants aged >/= 6 months and < 3 years received 10 mg/kg Bevacizumab every 2 weeks and 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
250432|NCT01390948|B2|Baseline|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
250433|NCT01390948|B1|Baseline|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
250434|NCT01390948|P3|Participant Flow|Bevacizumab + TMZ Young Patient Cohort (YPC)|Participants aged >/= 6 months and < 3 years received 10 mg/kg Bevacizumab every 2 weeks and 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
250435|NCT01390948|P2|Participant Flow|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 milligrams per kilogram (mg/kg) every 2 weeks throughout the entire treatment period.
251085|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
250436|NCT01390948|P1|Participant Flow|Chemoradiation + TMZ|Participants received a total dose of 54 Grey (Gy) units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 milligrams per meter squared (mg/m^2) TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
250437|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
250438|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
250439|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
250440|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
250441|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
250442|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
250443|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
250444|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
250445|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
250446|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
250447|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
250448|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
250449|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
250450|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
250451|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
250452|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
250453|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
250454|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
250455|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
250456|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
250457|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
250458|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
250459|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
250460|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
250461|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
250462|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
250463|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
250464|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
250465|NCT01390948|E3|Reported Event|Bevacizumab + TMZ Young Patient Cohort (YPC)|Participants aged >/= 6 months and < 3 years received 10 mg/kg Bevacizumab every 2 weeks and 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
250466|NCT01390948|E2|Reported Event|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
250467|NCT01390948|E1|Reported Event|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
250468|NCT01390909|B7|Baseline|Total|Total of all reporting groups
250469|NCT01390909|B6|Baseline|Private, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
250470|NCT01390909|B5|Baseline|Private, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup (602 participants) were matched with participant records in the Medicaid, well-controlled cohort.
250471|NCT01390909|B4|Baseline|Private, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
250472|NCT01390909|B3|Baseline|Medicaid, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
250473|NCT01390909|B2|Baseline|Medicaid, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup (3454 participants) were matched with participant records in the Medicaid, well-controlled cohort.
250474|NCT01390909|B1|Baseline|Medicaid, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
250475|NCT01390909|P6|Participant Flow|Private, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
250476|NCT01390909|P5|Participant Flow|Private, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup were matched with participant records in the Medicaid, well-controlled cohort.
250477|NCT01390909|P4|Participant Flow|Private, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visit
251086|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
250478|NCT01390909|P3|Participant Flow|Medicaid, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
250479|NCT01390909|P2|Participant Flow|Medicaid, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup were matched with participant records in the Medicaid, well-controlled cohort.
250480|NCT01390909|P1|Participant Flow|Medicaid, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
250481|NCT01390909|O8|Outcome|Private, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
250482|NCT01390909|O7|Outcome|Private, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy.
250483|NCT01390909|O6|Outcome|Private, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visit
250484|NCT01390909|O5|Outcome|Private, Uncontrolled, Subgroup|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This subgroup was matched with participant records in the private, well-controlled cohort.
250485|NCT01390909|O4|Outcome|Medicaid, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
250486|NCT01390909|O3|Outcome|Medicaid, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy
250487|NCT01390909|O2|Outcome|Medicaid, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
250488|NCT01390909|O1|Outcome|Medicaid, Uncontrolled, Subgroup|Database records for participants with 2 or more consecutive changes in anti-epileptic drug (AED) therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or emergency department (ED) visits within the next 365 days. This subgroup was matched with participant records in the Medicaid, well-controlled cohort
250489|NCT01390909|E8|Reported Event|Private, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
250490|NCT01390909|E7|Reported Event|Private, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy.
250491|NCT01390909|E6|Reported Event|Private, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visit
250492|NCT01390909|E5|Reported Event|Private, Uncontrolled, Subgroup|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This subgroup was matched with participant records in the private, well-controlled cohort.
250493|NCT01390909|E4|Reported Event|Medicaid, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
250494|NCT01390909|E3|Reported Event|Medicaid, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy
250495|NCT01390909|E2|Reported Event|Medicaid, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
250496|NCT01390909|E1|Reported Event|Medicaid, Uncontrolled, Subgroup|Database records for participants with 2 or more consecutive changes in anti-epileptic drug (AED) therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or emergency department (ED) visits within the next 365 days. This subgroup was matched with participant records in the Medicaid, well-controlled cohort
250497|NCT01390870|B1|Baseline|All Enrolled Participants|Males at least 50 years of age who were residents of the United States with one or more diagnoses of enlarged prostate and one or more filled prescription medications within the past 12 months for enlarged prostate (EP) (alpha blocker [AB], 5-alpha reductase inhibitor [5-ARI], combination therapy)
250498|NCT01390870|P1|Participant Flow|All Enrolled Participants|Males at least 50 years of age who were residents of the United States with one or more diagnoses of enlarged prostate and one or more filled prescription medications within the past 12 months for enlarged prostate (EP) (alpha blocker [AB], 5-alpha reductase inhibitor [5-ARI], combination therapy)
250499|NCT01390870|O1|Outcome|All Enrolled Participants|Males at least 50 years of age who were residents of the United States with one or more diagnoses of enlarged prostate and one or more filled prescription medications within the past 12 months for enlarged prostate (EP) (alpha blocker [AB], 5-alpha reductase inhibitor [5-ARI], combination therapy)
250500|NCT01390870|E1|Reported Event|All Enrolled Participants|Males at least 50 years of age who were residents of the United States with one or more diagnoses of enlarged prostate and one or more filled prescription medications within the past 12 months for enlarged prostate (EP) (alpha blocker [AB], 5-alpha reductase inhibitor [5-ARI], combination therapy)
250501|NCT01390857|B1|Baseline|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
250502|NCT01390857|P1|Participant Flow|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
250503|NCT01390857|O1|Outcome|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
256972|NCT01369745|E1|Reported Event|Prednisolone|Prednisolone 2.7 mg daily
250504|NCT01390857|O1|Outcome|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
250505|NCT01390857|O1|Outcome|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
250506|NCT01390857|O1|Outcome|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
250507|NCT01390857|E1|Reported Event|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
250508|NCT01390844|B5|Baseline|Total|Total of all reporting groups
250509|NCT01390844|B4|Baseline|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
250510|NCT01390844|B3|Baseline|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
250511|NCT01390844|B2|Baseline|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
250512|NCT01390844|B1|Baseline|Boceprevir - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
250513|NCT01390844|P4|Participant Flow|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
250514|NCT01390844|P3|Participant Flow|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
250515|NCT01390844|P2|Participant Flow|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
250516|NCT01390844|P1|Participant Flow|Boceprevir - Korea+Taiwan|PegIntron (pegylated interferon alfa-2b) (PEG) + ribavirin (RBV) for 4 weeks followed by boceprevir (BOC) + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
250517|NCT01390844|O2|Outcome|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
250518|NCT01390844|O1|Outcome|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
250519|NCT01390844|O2|Outcome|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
251087|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
250520|NCT01390844|O1|Outcome|Boceprevir - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
250521|NCT01390844|O2|Outcome|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
250522|NCT01390844|O1|Outcome|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
250523|NCT01390844|O2|Outcome|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
250524|NCT01390844|O1|Outcome|Boceprevir - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
250525|NCT01390844|O2|Outcome|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
250526|NCT01390844|O1|Outcome|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
250527|NCT01390844|O2|Outcome|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
250528|NCT01390844|O1|Outcome|Boceprevir - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
250529|NCT01390844|O2|Outcome|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
250530|NCT01390844|O1|Outcome|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
250531|NCT01390844|O2|Outcome|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
250561|NCT01390818|P11|Participant Flow|Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
251088|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
250532|NCT01390844|O1|Outcome|Boceprevir - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
250533|NCT01390844|O2|Outcome|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
250534|NCT01390844|O1|Outcome|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
250535|NCT01390844|O2|Outcome|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
250536|NCT01390844|O1|Outcome|Boceprevir - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
250537|NCT01390844|E4|Reported Event|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
250538|NCT01390844|E3|Reported Event|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
250539|NCT01390844|E2|Reported Event|Control - Korea + Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
250540|NCT01390844|E1|Reported Event|Boceprevir - Korea + Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
250541|NCT01390818|B16|Baseline|Total|Total of all reporting groups
250542|NCT01390818|B15|Baseline|MEL: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
250543|NCT01390818|B14|Baseline|CRC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
250544|NCT01390818|B13|Baseline|NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
250562|NCT01390818|P10|Participant Flow|Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
251089|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
250545|NCT01390818|B12|Baseline|TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
250546|NCT01390818|B11|Baseline|Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250547|NCT01390818|B10|Baseline|Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250548|NCT01390818|B9|Baseline|Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250549|NCT01390818|B8|Baseline|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250550|NCT01390818|B7|Baseline|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250551|NCT01390818|B6|Baseline|Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250552|NCT01390818|B5|Baseline|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250553|NCT01390818|B4|Baseline|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250554|NCT01390818|B3|Baseline|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250555|NCT01390818|B2|Baseline|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250556|NCT01390818|B1|Baseline|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250557|NCT01390818|P15|Participant Flow|MEL: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
250558|NCT01390818|P14|Participant Flow|CRC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
250559|NCT01390818|P13|Participant Flow|NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
250560|NCT01390818|P12|Participant Flow|TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
250847|NCT01390649|B1|Baseline|IgPro10|IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
250563|NCT01390818|P9|Participant Flow|Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250564|NCT01390818|P8|Participant Flow|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250565|NCT01390818|P7|Participant Flow|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250566|NCT01390818|P6|Participant Flow|Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250567|NCT01390818|P5|Participant Flow|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250568|NCT01390818|P4|Participant Flow|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250569|NCT01390818|P3|Participant Flow|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250570|NCT01390818|P2|Participant Flow|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250571|NCT01390818|P1|Participant Flow|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (Dose Escalation [DE] cohort).
250572|NCT01390818|O15|Outcome|MEL: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250573|NCT01390818|O14|Outcome|CRC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250574|NCT01390818|O13|Outcome|NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250575|NCT01390818|O12|Outcome|TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250576|NCT01390818|O11|Outcome|Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250577|NCT01390818|O10|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250578|NCT01390818|O9|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250579|NCT01390818|O8|Outcome|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250580|NCT01390818|O7|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250581|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250582|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250583|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250584|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250585|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250586|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250587|NCT01390818|O7|Outcome|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
250588|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
250589|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject
250590|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
250591|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
250592|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
250593|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
250594|NCT01390818|O7|Outcome|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
250595|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
250596|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject
250597|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
250621|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250598|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
250599|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
250600|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
250601|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250602|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250603|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250604|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250605|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250606|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250607|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250608|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250609|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250610|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250611|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250612|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250613|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250614|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250615|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
250616|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250617|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250618|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250619|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250620|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250844|NCT01390779|O1|Outcome|SENSIMED Triggerfish|
250845|NCT01390779|O1|Outcome|SENSIMED Triggerfish|
250846|NCT01390779|E1|Reported Event|SENSIMED Triggerfish|
250622|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250623|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250624|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250625|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250626|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250627|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250628|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250629|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250630|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250631|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250632|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250633|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250634|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250635|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250636|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250637|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250638|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250639|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250640|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250641|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250642|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250643|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250644|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250645|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
251090|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
256973|NCT01369732|B3|Baseline|Total|Total of all reporting groups
250646|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250647|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250648|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250649|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250650|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250651|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250652|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250653|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250654|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250655|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250656|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250657|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250658|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250659|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250660|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250661|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250662|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250663|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250664|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250665|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250666|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250667|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250668|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250669|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250941|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
250670|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250671|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250672|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250673|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250674|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250675|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250676|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250677|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250678|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250679|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250680|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250681|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250682|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250683|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250684|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250685|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250686|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250687|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250688|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250689|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250690|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250691|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250692|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250693|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
251091|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
250694|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250695|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250696|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250697|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250698|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250699|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250700|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250701|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250702|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250703|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250704|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250705|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250706|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250707|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250708|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250709|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250710|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250711|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250712|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250713|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250714|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250715|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250716|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
251092|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
266065|NCT01342081|B4|Baseline|Total|Total of all reporting groups
250717|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250718|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250719|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250720|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250721|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250722|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250723|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250724|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250725|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250726|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250727|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250728|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250729|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250730|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250731|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250732|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250733|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250734|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250735|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250736|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250737|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250738|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250739|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250740|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250741|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250742|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250743|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250744|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250745|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250746|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250747|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250748|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250749|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250750|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250751|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250752|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250753|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250754|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250755|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250756|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250757|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250758|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250759|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250760|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250761|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250762|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250763|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250764|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250765|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250766|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250767|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250768|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250769|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250770|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
250771|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250772|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250773|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250774|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250775|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250776|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250777|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250778|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250779|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250780|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250781|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250782|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250783|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250784|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250785|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250786|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250787|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250788|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250789|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250790|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250791|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250792|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250793|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250794|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
250795|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250796|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250797|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250798|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250799|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250800|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250801|NCT01390818|O15|Outcome|MEL: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
250802|NCT01390818|O14|Outcome|CRC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
250803|NCT01390818|O13|Outcome|NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
250804|NCT01390818|O12|Outcome|TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
250805|NCT01390818|O11|Outcome|MSC1936369B (Pimasertib) 45mg and SAR245409 50mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
266518|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
250806|NCT01390818|O10|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250807|NCT01390818|O9|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250808|NCT01390818|O8|Outcome|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250809|NCT01390818|O7|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250810|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250811|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250812|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250813|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250814|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250815|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250816|NCT01390818|O11|Outcome|Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250817|NCT01390818|O10|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250818|NCT01390818|O9|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250819|NCT01390818|O8|Outcome|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250820|NCT01390818|O7|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250821|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250822|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250823|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
251093|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
250824|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250825|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250826|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
250827|NCT01390818|E15|Reported Event|MEL: Pimasertib 60mg and SAR245409 70mg Once Daily|Participants with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).
250828|NCT01390818|E14|Reported Event|CRC: Pimasertib 60mg and SAR245409 70mg Once Daily|Participants with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).
250829|NCT01390818|E13|Reported Event|NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily|Participants with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).
250830|NCT01390818|E12|Reported Event|TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily|Participants with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).
250831|NCT01390818|E11|Reported Event|MSC1936369B (Pimasertib) 45mg and SAR245409 50mg Twice Daily|MSC1936369B (Pimasertib) capsule administered twice at a dose of 45 mg on day 1 and 15 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 and 15 of each cycle (21 days) (DE cohort).
250832|NCT01390818|E10|Reported Event|MSC1936369B (Pimasertib) 60mg and SAR245409 30mg Twice Daily|MSC1936369B (Pimasertib) capsule administered twice at a dose of 60 mg on day 1 and 15 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 and 15 of each cycle (21 days) (DE cohort).
250833|NCT01390818|E9|Reported Event|MSC1936369B (Pimasertib) 60mg and SAR245409 90mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 90 mg on day 1 of each cycle (21 days) (DE cohort).
250834|NCT01390818|E8|Reported Event|MSC1936369B (Pimasertib) 90mg and SAR245409 70mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 90 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).
250835|NCT01390818|E7|Reported Event|MSC1936369B (Pimasertib) 60mg and SAR245409 70mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).
250836|NCT01390818|E6|Reported Event|MSC1936369B (Pimasertib) 30mg and SAR245409 70mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).
250837|NCT01390818|E5|Reported Event|MSC1936369B (Pimasertib) 60mg and SAR245409 50mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).
250838|NCT01390818|E4|Reported Event|MSC1936369B (Pimasertib) 30mg and SAR245409 50mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).
250839|NCT01390818|E3|Reported Event|MSC1936369B (Pimasertib) 15mg and SAR245409 50mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 15 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).
250840|NCT01390818|E2|Reported Event|MSC1936369B (Pimasertib) 30mg and SAR245409 30mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) (DE cohort).
250841|NCT01390818|E1|Reported Event|MSC1936369B (Pimasertib) 15mg and SAR245409 30mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 15 milligram (mg) on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) (DE cohort).
250842|NCT01390779|B1|Baseline|SENSIMED Triggerfish|
250843|NCT01390779|P1|Participant Flow|SENSIMED Triggerfish|"All subjects enrolled in the trial were housed in a sleep laboratory for 24 hours, during which they underwent SENSIMED Triggerfish recording on one randomly selected eye.~Parallel IOP measurements were taken using pneumatonometry on the eye contralateral to the SENSIMED Triggerfish eye before and after sleep onset. During sleep heart rate measurements were collected at specified time points."
250848|NCT01390649|P1|Participant Flow|IgPro10|IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
250849|NCT01390649|O1|Outcome|IgPro10|IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
250850|NCT01390649|O1|Outcome|IgPro10|IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
250851|NCT01390649|E1|Reported Event|IgPro10|IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
250852|NCT01390441|B6|Baseline|Total|Total of all reporting groups
250853|NCT01390441|B5|Baseline|Part B: Rituxan® 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250854|NCT01390441|B4|Baseline|Part B: MabThera® 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250855|NCT01390441|B3|Baseline|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250856|NCT01390441|B2|Baseline|Part A: MabThera® 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250857|NCT01390441|B1|Baseline|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered intravenously (IV) on Day 1 and Day 15; (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250858|NCT01390441|P5|Participant Flow|Part B: Rituxan® 1000 mg / Extension B: MK-8808 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250859|NCT01390441|P4|Participant Flow|Part B: MabThera® 1000 mg / Extension B: MK-8808 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250860|NCT01390441|P3|Participant Flow|Part B: MK-8808 1000 mg / Extension B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250861|NCT01390441|P2|Participant Flow|Part A: MabThera® 500 mg/m^2 / Extension A: MK-8808 1000 mg|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250862|NCT01390441|P1|Participant Flow|Part A: MK-8808 500 mg/m^2 / Extension A: MK-8808 1000 mg|Participants receive one course of MK-8808 (500 mg/m^2) administered intravenously (IV) on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, subcutaneously (SC), or intramuscularly (IM) for the duration of the trial.
250863|NCT01390441|O5|Outcome|Extension B: Rituxan® 1000 mg/MK-8808 1000 mg|Participants who completed Part B Rituxan® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250864|NCT01390441|O4|Outcome|Extension B: MabThera® 1000 mg /MK-8808 1000 mg|Participants who completed Part B MabThera® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250865|NCT01390441|O3|Outcome|Extension B: MK-8808 1000 mg /MK-8808 1000 mg|Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250866|NCT01390441|O2|Outcome|Extension A: MabThera® 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MabThera® therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250867|NCT01390441|O1|Outcome|Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
251094|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
250868|NCT01390441|O5|Outcome|Extension B: Rituxan® 1000 mg/MK-8808 1000 mg|Participants who completed Part B Rituxan® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250869|NCT01390441|O4|Outcome|Extension B: MabThera® 1000 mg /MK-8808 1000 mg|Participants who completed Part B MabThera® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250870|NCT01390441|O3|Outcome|Extension B: MK-8808 1000 mg /MK-8808 1000 mg|Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250871|NCT01390441|O2|Outcome|Extension A: MabThera® 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MabThera® therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250872|NCT01390441|O1|Outcome|Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250873|NCT01390441|O2|Outcome|Part A: MabThera® 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250874|NCT01390441|O1|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, subcutaneously (SC), or IM for the duration of the trial.
250875|NCT01390441|O3|Outcome|Part B: Rituxan® 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250876|NCT01390441|O2|Outcome|Part B: MabThera® 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250877|NCT01390441|O1|Outcome|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250878|NCT01390441|O2|Outcome|Part A: MabThera® 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250879|NCT01390441|O1|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, subcutaneously SC, or IM for the duration of the trial.
250880|NCT01390441|O3|Outcome|Part B: Rituxan® 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250881|NCT01390441|O2|Outcome|Part B: MabThera® 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250882|NCT01390441|O1|Outcome|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250883|NCT01390441|O2|Outcome|Part A: MabThera® 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250884|NCT01390441|O1|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250885|NCT01390441|O10|Outcome|Extension B: Rituxan® 1000 mg/MK-8808 1000 mg|Participants who completed Part B Rituxan® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250886|NCT01390441|O9|Outcome|Extension B: MabThera® 1000 mg /MK-8808 1000 mg|Participants who completed Part B MabThera® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250887|NCT01390441|O8|Outcome|Extension B: MK-8808 1000 mg /MK-8808 1000 mg|Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250888|NCT01390441|O7|Outcome|Extension A: MabThera® 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MabThera® therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
251095|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
250889|NCT01390441|O6|Outcome|Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250890|NCT01390441|O5|Outcome|Part B: Rituxan® 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250891|NCT01390441|O4|Outcome|Part B: MabThera® 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250892|NCT01390441|O3|Outcome|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250893|NCT01390441|O2|Outcome|Part A: MabThera® 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250894|NCT01390441|O1|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250895|NCT01390441|O10|Outcome|Extension B: Rituxan1000 mg/MK-8808 1000 mg|Participants who completed Part B Rituxan will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250896|NCT01390441|O9|Outcome|Extension B: MabThera 1000 mg /MK-8808 1000 mg|Participants who completed Part B MabThera will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250897|NCT01390441|O8|Outcome|Extension B: MK-8808 1000 mg /MK-8808 1000 mg|Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250898|NCT01390441|O7|Outcome|Extension A: MabThera 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MabThera therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250899|NCT01390441|O6|Outcome|Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250900|NCT01390441|O5|Outcome|Part B: Rituxan 1000 mg|Participants receive one course of Rituxan (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250901|NCT01390441|O4|Outcome|Part B: MabThera 1000 mg|Participants receive one course of MabThera (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250902|NCT01390441|O3|Outcome|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250903|NCT01390441|O2|Outcome|Part A: MabThera 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250904|NCT01390441|O1|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250905|NCT01390441|O3|Outcome|Part B: Rituxan® 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250906|NCT01390441|O2|Outcome|Part B: MabThera® 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250907|NCT01390441|O1|Outcome|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250908|NCT01390441|O2|Outcome|Part A: MabThera® 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250909|NCT01390441|O1|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250942|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
251096|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
250910|NCT01390441|E10|Reported Event|Extension B: Rituxan® 1000 mg/MK-8808 1000 mg|Participants who completed Part B Rituxan® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250911|NCT01390441|E9|Reported Event|Extension B: MabThera® 1000 mg /MK-8808 1000 mg|Participants who completed Part B MabThera® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250912|NCT01390441|E8|Reported Event|Extension B: MK-8808 1000 mg /MK-8808 1000 mg|Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250913|NCT01390441|E7|Reported Event|Extension A: MabThera® 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MabThera® therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250914|NCT01390441|E6|Reported Event|Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250915|NCT01390441|E5|Reported Event|Part B: Rituxan 1000 mg|Participants receive one course of Rituxan (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250916|NCT01390441|E4|Reported Event|Part B: MabThera 1000 mg|Participants receive one course of MabThera (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250917|NCT01390441|E3|Reported Event|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250918|NCT01390441|E2|Reported Event|Part A: MabThera 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250919|NCT01390441|E1|Reported Event|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15; (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
250920|NCT01390428|B7|Baseline|Total|Total of all reporting groups
250921|NCT01390428|B6|Baseline|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
250922|NCT01390428|B5|Baseline|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
250923|NCT01390428|B4|Baseline|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
250924|NCT01390428|B3|Baseline|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
250925|NCT01390428|B2|Baseline|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
250926|NCT01390428|B1|Baseline|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
250927|NCT01390428|P6|Participant Flow|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
250928|NCT01390428|P5|Participant Flow|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
250929|NCT01390428|P4|Participant Flow|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
250930|NCT01390428|P3|Participant Flow|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
250931|NCT01390428|P2|Participant Flow|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
250932|NCT01390428|P1|Participant Flow|Part 1-Mild Hepatic Impairment (HI)|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
250933|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
250934|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
250935|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
250936|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
250937|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
250938|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
250939|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
250940|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
250943|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
250944|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
250945|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
250946|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
250947|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
250948|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
250949|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
250950|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
250951|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
250952|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
250953|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
250954|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
250955|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
250956|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
250957|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
250958|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
250959|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
250960|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
250961|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
250962|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
250963|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
250964|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
250965|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
250966|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
250967|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
250968|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
250969|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
250970|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
250971|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
250972|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
250973|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
250974|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
250975|NCT01390428|E6|Reported Event|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
250976|NCT01390428|E5|Reported Event|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
250977|NCT01390428|E4|Reported Event|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
250978|NCT01390428|E3|Reported Event|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
250979|NCT01390428|E2|Reported Event|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
250980|NCT01390428|E1|Reported Event|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
250981|NCT01390415|B3|Baseline|Total|Total of all reporting groups
250982|NCT01390415|B2|Baseline|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
250983|NCT01390415|B1|Baseline|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
250984|NCT01390415|P2|Participant Flow|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
250985|NCT01390415|P1|Participant Flow|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
250986|NCT01390415|O2|Outcome|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
250987|NCT01390415|O1|Outcome|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
250988|NCT01390415|O2|Outcome|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
250989|NCT01390415|O1|Outcome|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
250990|NCT01390415|O2|Outcome|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
250991|NCT01390415|O1|Outcome|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
250992|NCT01390415|E2|Reported Event|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
250993|NCT01390415|E1|Reported Event|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
250994|NCT01390402|B1|Baseline|NK Infusion + Chemotherapy|Fludarabine 40 mg/m^2 intravenous (IV) daily for four (4) consecutive days, Days -13 to -10, immediately followed by Busulfan 130 mg/ m^2 IV for 2 doses on Days -11 to -10 and Natural killer (NK) cell infusion Iv administered on Day -8. Interleukin-2: 0.5 million units subcutaneously daily for 5 days on Day -8 to day -4; Anti-Thymocyte Globulin: 2.5 mg/kg IV for 3 doses on Days -3 to -1. Allogeneic related stem cell transplant IV Day 0. Tacrolimus: Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Methotrexate 5 mg/m2 by vein Days 1, 3 and 6 post transplant. G-CSF 5 mcg/kg/day subcutaneously beginning on Day + 7.
250995|NCT01390402|P1|Participant Flow|NK Infusion + Chemotherapy|Fludarabine 40 mg/m^2 intravenous (IV) daily for four (4) consecutive days, Days -13 to -10, immediately followed by Busulfan 130 mg/ m^2 IV for 2 doses on Days -11 to -10 and Natural killer (NK) cell infusion Iv administered on Day -8. Interleukin-2: 0.5 million units subcutaneously daily for 5 days on Day -8 to day -4; Anti-Thymocyte Globulin: 2.5 mg/kg IV for 3 doses on Days -3 to -1. Allogeneic related stem cell transplant IV Day 0. Tacrolimus: Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Methotrexate 5 mg/m2 by vein Days 1, 3 and 6 post transplant. G-CSF 5 mcg/kg/day subcutaneously beginning on Day + 7.
250996|NCT01390402|O1|Outcome|NK Infusion + Chemotherapy|Fludarabine 40 mg/m^2 intravenous (IV) daily for four (4) consecutive days, Days -13 to -10, immediately followed by Busulfan 130 mg/ m^2 IV for 2 doses on Days -11 to -10 and Natural killer (NK) cell infusion Iv administered on Day -8. Interleukin-2: 0.5 million units subcutaneously daily for 5 days on Day -8 to day -4; Anti-Thymocyte Globulin: 2.5 mg/kg IV for 3 doses on Days -3 to -1. Allogeneic related stem cell transplant IV Day 0. Tacrolimus: Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Methotrexate 5 mg/m2 by vein Days 1, 3 and 6 post transplant. G-CSF 5 mcg/kg/day subcutaneously beginning on Day + 7.
250997|NCT01390402|E1|Reported Event|NK Infusion + Chemotherapy|Fludarabine 40 mg/m^2 intravenous (IV) daily for four (4) consecutive days, Days -13 to -10, immediately followed by Busulfan 130 mg/ m^2 IV for 2 doses on Days -11 to -10 and Natural killer (NK) cell infusion Iv administered on Day -8. Interleukin-2: 0.5 million units subcutaneously daily for 5 days on Day -8 to day -4; Anti-Thymocyte Globulin: 2.5 mg/kg IV for 3 doses on Days -3 to -1. Allogeneic related stem cell transplant IV Day 0. Tacrolimus: Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Methotrexate 5 mg/m2 by vein Days 1, 3 and 6 post transplant. G-CSF 5 mcg/kg/day subcutaneously beginning on Day + 7.
250998|NCT01390389|B3|Baseline|Total|Total of all reporting groups
250999|NCT01390389|B2|Baseline|CoQ10|Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
251000|NCT01390389|B1|Baseline|Control|Healthy controls with no evidence of current or past psychiatric disorders.
251001|NCT01390389|P2|Participant Flow|CoQ10|Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
251002|NCT01390389|P1|Participant Flow|Control|Healthy controls with no evidence of current or past psychiatric disorders.
251003|NCT01390389|O4|Outcome|CoQ10 Week 4|Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
251004|NCT01390389|O3|Outcome|CoQ10 Baseline (Week 0)|Subjects with Bipolar disorder who had not yet received study drug.
251005|NCT01390389|O2|Outcome|Control Week 4|Healthy controls with no evidence of current or past psychiatric disorders. Subjects did not receive study drug.
251006|NCT01390389|O1|Outcome|Control Baseline (Week 0)|Healthy controls with no evidence of current or past psychiatric disorders.
251007|NCT01390389|O2|Outcome|CoQ10|Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
251009|NCT01390389|E2|Reported Event|CoQ10|Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
251010|NCT01390389|E1|Reported Event|Control|Healthy controls with no evidence of current or past psychiatric disorders.
251011|NCT01390259|B1|Baseline|Adolescents|"Adolescents participated in both the Standard Control to Range (sCTR) Closed-Loop Control (CLC) Admission and the Open-Loop admission.~Experimental: The CLC used a computer to make recommendations for their insulin treatment. This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Placebo Comparator: Open Loop. The subjects were in charge of their insulin treatment."
251012|NCT01390259|P2|Participant Flow|Closed-Loop Control First, Then Open-Loop|"Closed-Loop control (CLC) first, then Open-Loop~Experimental, CLC admission: The CLC used a computer to make recommendations for their insulin treatment. This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Placebo Comparator: Open Loop admission. The subjects were in charge of their insulin treatment."
251013|NCT01390259|P1|Participant Flow|Open-Loop First, Then Closed-Loop|"Open-Loop first, then Closed-Loop control (CLC)~Experimental, CLC admission: The CLC used a computer to make recommendations for their insulin treatment. This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Placebo Comparator: Open Loop admission. The subjects were in charge of their insulin treatment."
251014|NCT01390259|O2|Outcome|Open-Loop|"The subjects were in charge of their insulin treatment.~Open-Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...)."
251015|NCT01390259|O1|Outcome|Closed-Loop Control (CLC)|"The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Closed-Loop: During the closed-loop admission, the computer based algorithm used CGM values to make recommendations of insulin treatment. Standard Control to Range (sCTR)."
251016|NCT01390259|O2|Outcome|Open-Loop|"The subjects were in charge of their insulin treatment.~Open-Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...)."
251017|NCT01390259|O1|Outcome|Closed-Loop Control (CLC)|"The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Closed-Loop: During the closed-loop admission, the computer based algorithm used CGM values to make recommendations of insulin treatment. Standard Control to Range (sCTR)."
251018|NCT01390259|O2|Outcome|Open-Loop|"The subjects were in charge of their insulin treatment.~Open-Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...)."
251019|NCT01390259|O1|Outcome|Closed-Loop Control (CLC)|"The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Closed-Loop: During the closed-loop admission, the computer based algorithm used CGM values to make recommendations of insulin treatment. Standard Control to Range (sCTR)."
251070|NCT01389973|E1|Reported Event|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
251071|NCT01389882|B3|Baseline|Total|Total of all reporting groups
251020|NCT01390259|E1|Reported Event|Adolescents|"Adolescents participated in both the Standard Control to Range (sCTR) Closed-Loop Control (CLC) Admission and the Open-Loop admission.~Experimental: The CLC used a computer to make recommendations for their insulin treatment. This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Placebo Comparator: Open Loop. The subjects were in charge of their insulin treatment."
251021|NCT01390246|B3|Baseline|Total|Total of all reporting groups
251022|NCT01390246|B2|Baseline|Placebo|"Subjects received matched bupropion SR placebo tablet orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.~Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."
251023|NCT01390246|B1|Baseline|Bupropion SR|"Subjects received 150 mg tablet bupropion SR orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.~Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."
251024|NCT01390246|P2|Participant Flow|Placebo|"Subjects received matched bupropion SR placebo tablet orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.~Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."
251025|NCT01390246|P1|Participant Flow|Bupropion SR|"Subjects received 150 mg tablet bupropion SR orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.~Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."
251026|NCT01390246|O2|Outcome|Placebo|"Subjects received matched bupropion SR placebo tablet orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.~Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."
251027|NCT01390246|O1|Outcome|Bupropion SR|"Subjects received 150 mg tablet bupropion SR orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.~Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."
251028|NCT01390246|O2|Outcome|Placebo|"Subjects received matched bupropion SR placebo tablet orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.~Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."
251029|NCT01390246|O1|Outcome|Bupropion SR|"Subjects received 150 mg tablet bupropion SR orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.~Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."
251030|NCT01390246|O2|Outcome|Placebo|"Subjects received matched bupropion SR placebo tablet orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.~Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."
251031|NCT01390246|O1|Outcome|Bupropion SR|"Subjects received 150 mg tablet bupropion SR orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.~Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."
251032|NCT01390246|O2|Outcome|Placebo|"Subjects received matched bupropion SR placebo tablet orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.~Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."
251033|NCT01390246|O1|Outcome|Bupropion SR|"Subjects received 150 mg tablet bupropion SR orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.~Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."
251034|NCT01390246|E2|Reported Event|Placebo|"Subjects received matched bupropion SR placebo tablet orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.~Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."
251035|NCT01390246|E1|Reported Event|Bupropion SR|"Subjects received 150 mg tablet bupropion SR orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.~Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."
251036|NCT01390233|B4|Baseline|Total|Total of all reporting groups
251072|NCT01389882|B2|Baseline|NS Group|NAVA first, then SIMV with PS
251073|NCT01389882|B1|Baseline|SN Group|Synchronized intermittent mandatory ventilation (SIMV) with Pressure support (PS) first, then Neurally adjusted ventilatory assist (NAVA)
251074|NCT01389882|P2|Participant Flow|NS Group|NAVA first, then SIMV with PS
251075|NCT01389882|P1|Participant Flow|SN Group|Synchronized intermittent mandatory ventilation (SIMV) with Pressure support (PS) first, then Neurally adjusted ventilatory assist (NAVA)
251076|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
251037|NCT01390233|B3|Baseline|Combined Urinary Catheter & Prepadil Gel|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.~Urinary Balloon Catheter Device and Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment."
251038|NCT01390233|B2|Baseline|Prepadil Only|"Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel in the vagina."
251039|NCT01390233|B1|Baseline|Urinary Balloon Catheter Only|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Urinary Balloon Catheter: Pre-induction cervical ripening using a urinary balloon catheter device."
251040|NCT01390233|P3|Participant Flow|Combined Urinary Catheter & Prepadil Gel|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.~Urinary Balloon Catheter Device and Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment."
251041|NCT01390233|P2|Participant Flow|Prepadil Only|"Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel in the vagina."
251042|NCT01390233|P1|Participant Flow|Urinary Balloon Catheter Only|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Urinary Balloon Catheter: Pre-induction cervical ripening using a urinary balloon catheter device."
251043|NCT01390233|O3|Outcome|Combined Urinary Catheter & Prepadil Gel|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.~Urinary Balloon Catheter Device and Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment."
251044|NCT01390233|O2|Outcome|Prepadil Only|"Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel in the vagina."
251045|NCT01390233|O1|Outcome|Urinary Balloon Catheter Only|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Urinary Balloon Catheter: Pre-induction cervical ripening using a urinary balloon catheter device."
251077|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
251078|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
251079|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
251080|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
251081|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
251082|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
251083|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
251046|NCT01390233|E3|Reported Event|Combined Urinary Catheter & Prepadil Gel|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.~Urinary Balloon Catheter Device and Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment."
251047|NCT01390233|E2|Reported Event|Prepadil Only|"Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel in the vagina."
251048|NCT01390233|E1|Reported Event|Urinary Balloon Catheter Only|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Urinary Balloon Catheter: Pre-induction cervical ripening using a urinary balloon catheter device."
251049|NCT01390181|B1|Baseline|Losartan|Cozaar: Angiotensin II Receptor Blocker
251050|NCT01390181|P1|Participant Flow|Losartan|Cozaar: Angiotensin II Receptor Blocker
251051|NCT01390181|O1|Outcome|Losartan|Cozaar: Angiotensin II Receptor Blocker
251052|NCT01390181|E1|Reported Event|Losartan|Cozaar: Angiotensin II Receptor Blocker
251053|NCT01390038|B1|Baseline|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
251054|NCT01390038|P1|Participant Flow|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
251055|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
251056|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
251057|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
251058|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
251059|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
251060|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
251061|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
251062|NCT01390038|E1|Reported Event|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
251063|NCT01389973|B1|Baseline|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
251064|NCT01389973|P1|Participant Flow|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
251065|NCT01389973|O1|Outcome|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
251066|NCT01389973|O1|Outcome|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
251067|NCT01389973|O1|Outcome|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
251068|NCT01389973|O1|Outcome|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
251069|NCT01389973|O1|Outcome|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
251084|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
251097|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
251098|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
251099|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
251100|NCT01389882|E2|Reported Event|NS Group|NAVA first, then SIMV with PS
251101|NCT01389882|E1|Reported Event|SN Group|Synchronized intermittent mandatory ventilation (SIMV) with Pressure support (PS) first, then Neurally adjusted ventilatory assist (NAVA)
251102|NCT01389856|B3|Baseline|Total|Total of all reporting groups
251103|NCT01389856|B2|Baseline|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
251104|NCT01389856|B1|Baseline|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251105|NCT01389856|P2|Participant Flow|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
251106|NCT01389856|P1|Participant Flow|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251107|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251108|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251109|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251110|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251111|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251112|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251113|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251114|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251115|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251116|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251117|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251118|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251119|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251120|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251121|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251122|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
251123|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251124|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
251125|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251126|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
251127|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251128|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
251129|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251130|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
266519|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
251131|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251132|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
251133|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251134|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
251135|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251136|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
251137|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251138|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
251139|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251140|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
251141|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251142|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
251143|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251144|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
251145|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251146|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
251147|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251148|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
251149|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251150|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
251151|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251152|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
251153|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251154|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
251155|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251156|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
251157|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251158|NCT01389856|E2|Reported Event|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
251159|NCT01389856|E1|Reported Event|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
251160|NCT01389817|B3|Baseline|Total|Total of all reporting groups
251161|NCT01389817|B2|Baseline|Asymptomatic LHON Mutation Carriers|Study Arm 2) asymptomatic LHON mutation carriers. Can be male or female; have some dysfunction, with changes occurring over months. Patients in study arm 2 will not be exposed to NIR-LED, but only undergo diagnostic studies.
251295|NCT01389102|B2|Baseline|Placebo Transdermal Two 90 μL Sprays|Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
251162|NCT01389817|B1|Baseline|Symptomatic LHON Patients.|"Study Arm 1) symptomatic LHON patients. Male and female LHON patients with treatable bilateral optic atrophy. Treat the worse of the 2 eyes if there is a measurable difference in subjective visual functions (visual acuity, peripheral vision).~Near-infrared light-emitting diode (NIR-LED) therapy (Med Light 630 PRO (Medical Devices Inc.)): Subjects will be exposed to light emitted from a Med Light 630 PRO (Medical Devices Inc.) at a wavelength of 630 nm (+/-15nm) with an exposure of 4 J/cm2. This is accomplished by applying the 50 mW/cm2 LED-generated light to the closed study eye for 80 seconds. Treatments involve application of the LED-generated light for 80 seconds, twice daily."
251163|NCT01389817|P2|Participant Flow|Asymptomatic LHON Mutation Carriers|Study Arm 2) asymptomatic LHON mutation carriers. Can be male or female; have some dysfunction, with changes occurring over months. Patients in study arm 2 will not be exposed to NIR-LED, but only undergo diagnostic studies.
251164|NCT01389817|P1|Participant Flow|Symptomatic LHON Patients.|"Study Arm 1) symptomatic LHON patients. Male and female LHON patients with treatable bilateral optic atrophy. Treat the worse of the 2 eyes if there is a measurable difference in subjective visual functions (visual acuity, peripheral vision).~Near-infrared light-emitting diode (NIR-LED) therapy (Med Light 630 PRO (Medical Devices Inc.)): Subjects will be exposed to light emitted from a Med Light 630 PRO (Medical Devices Inc.) at a wavelength of 630 nm (+/-15nm) with an exposure of 4 J/cm2. This is accomplished by applying the 50 mW/cm2 LED-generated light to the closed study eye for 80 seconds. Treatments involve application of the LED-generated light for 80 seconds, twice daily."
251165|NCT01389817|O2|Outcome|Asymptomatic LHON Mutation Carriers|Study Arm 2) asymptomatic LHON mutation carriers. Can be male or female; have some dysfunction, with changes occurring over months. Patients in study arm 2 will not be exposed to NIR-LED, but only undergo diagnostic studies.
251166|NCT01389817|O1|Outcome|Symptomatic LHON Patients.|"Study Arm 1) symptomatic LHON patients. Male and female LHON patients with treatable bilateral optic atrophy. Treat the worse of the 2 eyes if there is a measurable difference in subjective visual functions (visual acuity, peripheral vision).~Near-infrared light-emitting diode (NIR-LED) therapy (Med Light 630 PRO (Medical Devices Inc.)): Subjects will be exposed to light emitted from a Med Light 630 PRO (Medical Devices Inc.) at a wavelength of 630 nm (+/-15nm) with an exposure of 4 J/cm2. This is accomplished by applying the 50 mW/cm2 LED-generated light to the closed study eye for 80 seconds. Treatments involve application of the LED-generated light for 80 seconds, twice daily."
251167|NCT01389817|E2|Reported Event|Asymptomatic LHON Mutation Carriers|Study Arm 2) asymptomatic LHON mutation carriers. Can be male or female; have some dysfunction, with changes occurring over months. Patients in study arm 2 will not be exposed to NIR-LED, but only undergo diagnostic studies.
251168|NCT01389817|E1|Reported Event|Symptomatic LHON Patients.|"Study Arm 1) symptomatic LHON patients. Male and female LHON patients with treatable bilateral optic atrophy. Treat the worse of the 2 eyes if there is a measurable difference in subjective visual functions (visual acuity, peripheral vision).~Near-infrared light-emitting diode (NIR-LED) therapy (Med Light 630 PRO (Medical Devices Inc.)): Subjects will be exposed to light emitted from a Med Light 630 PRO (Medical Devices Inc.) at a wavelength of 630 nm (+/-15nm) with an exposure of 4 J/cm2. This is accomplished by applying the 50 mW/cm2 LED-generated light to the closed study eye for 80 seconds. Treatments involve application of the LED-generated light for 80 seconds, twice daily."
251169|NCT01389596|B4|Baseline|Total|Total of all reporting groups
251170|NCT01389596|B3|Baseline|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
251171|NCT01389596|B2|Baseline|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251172|NCT01389596|B1|Baseline|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251173|NCT01389596|P3|Participant Flow|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
251174|NCT01389596|P2|Participant Flow|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251175|NCT01389596|P1|Participant Flow|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and less than (<) 30 kilograms (kg) in weight, received pregabalin 3.5 milligram per kilogram per day (mg/kg/day) (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and greater than or equal to (>=) 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251176|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
251675|NCT01387230|E2|Reported Event|UMEC 62.5 µg|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
251177|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251178|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251179|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
251180|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251181|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251182|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
251183|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251184|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251185|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
251186|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251187|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251188|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
251189|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251190|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251191|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
251192|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251193|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251194|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
251195|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251196|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251197|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
251198|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251199|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251200|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
251201|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251202|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251203|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
251204|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251205|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251206|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
251207|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251208|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251209|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
251210|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251211|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251212|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
251213|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251214|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251215|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
251216|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251217|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251218|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
251219|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251220|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251221|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
251222|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251223|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251224|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
251225|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251226|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251227|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
251228|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251229|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251230|NCT01389596|E3|Reported Event|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
251231|NCT01389596|E2|Reported Event|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251232|NCT01389596|E1|Reported Event|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
251233|NCT01389323|B1|Baseline|Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin|Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events.
251234|NCT01389323|P1|Participant Flow|Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin|Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events.
251235|NCT01389323|O5|Outcome|Overall Population|Participants received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing <75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
251236|NCT01389323|O4|Outcome|Non-Latino Cohort|Participants belonging to Non-Latino ethnicity, received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing <75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
251237|NCT01389323|O3|Outcome|Latino Cohort|Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
251238|NCT01389323|O2|Outcome|White/Caucasian Cohort|Participants belonging to White/Caucasian race, received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing <75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included Latino and Non-Latino participants.
251239|NCT01389323|O1|Outcome|Black/African American Cohort|Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included Latino and Non-Latino participants.
251240|NCT01389323|O3|Outcome|White Non-Latino Cohort|Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
251241|NCT01389323|O2|Outcome|Latino Cohort|Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
251242|NCT01389323|O1|Outcome|Black/African American Cohort|Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events (AEs). This cohort included Latino and Non-Latino participants.
251267|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
251676|NCT01387230|E1|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
251243|NCT01389323|O3|Outcome|White Non-Latino Cohort|Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
251244|NCT01389323|O2|Outcome|Latino Cohort|Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
251245|NCT01389323|O1|Outcome|Black/African American Cohort|Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events (AEs). This cohort included Latino and Non-Latino participants.
251246|NCT01389323|O3|Outcome|White Non-Latino Cohort|Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
251247|NCT01389323|O2|Outcome|Latino Cohort|Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
251248|NCT01389323|O1|Outcome|Black/African American Cohort|Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events (AEs). This cohort included Latino and Non-Latino participants.
251249|NCT01389323|O3|Outcome|White Non-Latino Cohort|Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
251268|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
251269|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
251296|NCT01389102|B1|Baseline|Placebo Transdermal Three 90 μL Sprays|Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
251250|NCT01389323|O2|Outcome|Latino Cohort|Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
251251|NCT01389323|O1|Outcome|Black/African American Cohort|Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events (AEs). This cohort included Latino and Non-Latino participants.
251252|NCT01389323|E1|Reported Event|Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin|Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events.
251253|NCT01389284|B4|Baseline|Total|Total of all reporting groups
251254|NCT01389284|B3|Baseline|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
251255|NCT01389284|B2|Baseline|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
251256|NCT01389284|B1|Baseline|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
251257|NCT01389284|P3|Participant Flow|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
251258|NCT01389284|P2|Participant Flow|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
251259|NCT01389284|P1|Participant Flow|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
251260|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
251261|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
251262|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
251263|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
251264|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
251265|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
251266|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
251294|NCT01389102|B3|Baseline|Placebo Transdermal One 90 μL Spray|Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
251270|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
251271|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
251272|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
251273|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
251274|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
251275|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
251276|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
251277|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
251278|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
251279|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
251280|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
251281|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
251282|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
251283|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
251284|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
251285|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
251286|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
251287|NCT01389284|E3|Reported Event|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
251288|NCT01389284|E2|Reported Event|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
251289|NCT01389284|E1|Reported Event|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
251290|NCT01389102|B7|Baseline|Total|Total of all reporting groups
251291|NCT01389102|B6|Baseline|Estradiol Transdermal One 90 μL Spray|Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
251292|NCT01389102|B5|Baseline|Estradiol Transdermal Two 90 μL Sprays|Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
251293|NCT01389102|B4|Baseline|Estradiol Transdermal Three 90 μL Sprays|Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
251297|NCT01389102|P6|Participant Flow|Estradiol Transdermal One 90 μL Spray|Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
251298|NCT01389102|P5|Participant Flow|Estradiol Transdermal Two 90 μL Sprays|Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
251299|NCT01389102|P4|Participant Flow|Estradiol Transdermal Three 90 μL Sprays|Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
251300|NCT01389102|P3|Participant Flow|Placebo Transdermal One 90 μL Spray|Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
251301|NCT01389102|P2|Participant Flow|Placebo Transdermal Two 90 μL Sprays|Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
251302|NCT01389102|P1|Participant Flow|Placebo Transdermal Three 90 μL Sprays|Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
251303|NCT01389102|O6|Outcome|Estradiol Transdermal One 90 μL Spray|Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
251304|NCT01389102|O5|Outcome|Estradiol Transdermal Two 90 μL Sprays|Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
251305|NCT01389102|O4|Outcome|Estradiol Transdermal Three 90 μL Sprays|Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
251306|NCT01389102|O3|Outcome|Placebo Transdermal One 90 μL Spray|Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
251307|NCT01389102|O2|Outcome|Placebo Transdermal Two 90 μL Sprays|Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
251308|NCT01389102|O1|Outcome|Placebo Transdermal Three 90 μL Sprays|Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
251309|NCT01389102|O6|Outcome|Estradiol Transdermal One 90 μL Spray|
251310|NCT01389102|O5|Outcome|Estradiol Transdermal Two 90 μL Sprays|
251311|NCT01389102|O4|Outcome|Estradiol Transdermal Three 90 μL Sprays|
251312|NCT01389102|O3|Outcome|Placebo Transdermal One 90 μL Spray|
251313|NCT01389102|O2|Outcome|Placebo Transdermal Two 90 μL Sprays|
251314|NCT01389102|O1|Outcome|Placebo Transdermal Three 90 μL Sprays|
251315|NCT01389102|E6|Reported Event|Estradiol Transdermal One 90 μL Spray|Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
251316|NCT01389102|E5|Reported Event|Estradiol Transdermal Two 90 μL Sprays|Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
251317|NCT01389102|E4|Reported Event|Estradiol Transdermal Three 90 μL Sprays|Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
251318|NCT01389102|E3|Reported Event|Placebo Transdermal One 90 μL Spray|Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
251319|NCT01389102|E2|Reported Event|Placebo Transdermal Two 90 μL Sprays|Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
251320|NCT01389102|E1|Reported Event|Placebo Transdermal Three 90 μL Sprays|Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
251321|NCT01389076|B1|Baseline|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
251322|NCT01389076|P1|Participant Flow|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
251323|NCT01389076|O1|Outcome|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
251324|NCT01389076|O1|Outcome|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
251325|NCT01389076|O1|Outcome|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
251377|NCT01388907|B3|Baseline|Total|Total of all reporting groups
251378|NCT01388907|B2|Baseline|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
251677|NCT01387178|B3|Baseline|Total|Total of all reporting groups
251326|NCT01389076|O1|Outcome|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
251327|NCT01389076|O1|Outcome|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
251328|NCT01389076|E1|Reported Event|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
251329|NCT01388946|B3|Baseline|Total|Total of all reporting groups
251330|NCT01388946|B2|Baseline|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
251331|NCT01388946|B1|Baseline|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
251332|NCT01388946|P2|Participant Flow|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
251333|NCT01388946|P1|Participant Flow|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
251334|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
251335|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
251336|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
251337|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
251338|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
251339|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
251340|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
251341|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
251342|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
251343|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
251344|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
251345|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
251346|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
251347|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
251348|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
251349|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
251350|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
251351|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
251352|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
251353|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
251354|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
251355|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
251356|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
251357|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
251358|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
251359|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
251360|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
251361|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
251362|NCT01388946|E2|Reported Event|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
251363|NCT01388946|E1|Reported Event|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
251364|NCT01388920|B4|Baseline|Total|Total of all reporting groups
251365|NCT01388920|B3|Baseline|Placebo|Placebo for 6 months
251366|NCT01388920|B2|Baseline|Tesamorelin 3 mg|Tesamorelin 3 mg/day for 6 months
251367|NCT01388920|B1|Baseline|Tesamorelin 2 mg|Tesamorelin 2 mg/day for 6 months
251368|NCT01388920|P3|Participant Flow|Placebo|Placebo for 6 monts
251369|NCT01388920|P2|Participant Flow|Tesamorelin 3 mg|Tesamorelin 3 mg/day for 6 months
251370|NCT01388920|P1|Participant Flow|Tesamorelin 2 mg|Tesamorelin 2 mg/day for 6 months
251371|NCT01388920|O3|Outcome|Placebo|Placebo for 6 months
251372|NCT01388920|O2|Outcome|Tesamorelin 3 mg|Tesamorelin 3 mg/day for 6 months
251373|NCT01388920|O1|Outcome|Tesamorelin 2 mg|Tesamorelin 2 mg/day for 6 months
251374|NCT01388920|E3|Reported Event|Placebo|Placebo for 6 months
251375|NCT01388920|E2|Reported Event|Tesamorelin 3 mg|Tesamorelin 3 mg/day for 6 months
251376|NCT01388920|E1|Reported Event|Tesamorelin 2 mg|Tesamorelin 2 mg/day for 6 months
251379|NCT01388907|B1|Baseline|Prevadh™ (P) Group|Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formati.
251380|NCT01388907|P2|Participant Flow|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
251381|NCT01388907|P1|Participant Flow|Prevadh™ (P) Group|Patients randomized in the Prevadh group have been treated with Prevadh film directly applied to the uterine surgical sites at the end of the myomectomy surgery.
251382|NCT01388907|O2|Outcome|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
251383|NCT01388907|O1|Outcome|Prevadh™ (P) Group|Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formati.
251384|NCT01388907|O2|Outcome|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
251385|NCT01388907|O1|Outcome|Prevadh™ (P) Group|Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formati.
251386|NCT01388907|O2|Outcome|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
251387|NCT01388907|O1|Outcome|Prevadh™ (P) Group|Patients randomized in the Prevadh group have been treated with Prevadh film directly applied to the uterine surgical sites at the end of the myomectomy surgery.
251388|NCT01388907|O2|Outcome|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
251389|NCT01388907|O1|Outcome|Prevadh™ (P) Group|Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formation.
251390|NCT01388907|E2|Reported Event|Ringer Lactate™ (R) Group With Adverse Event|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
251391|NCT01388907|E1|Reported Event|Prevadh™ (P) Group With Adverse Event|Patients randomized in the Prevadh group have been treated with Prevadh Film directly applied to the uterine surgical sites at the end of the myomectomy surgery.
251392|NCT01388816|B5|Baseline|Total|Total of all reporting groups
251393|NCT01388816|B4|Baseline|DRL-17822 300 mg|Once daily after breakfast
251394|NCT01388816|B3|Baseline|DRL-17822 150 mg|Once daily after breakfast
251395|NCT01388816|B2|Baseline|DRL-17822 50 mg|Once daily after breakfast
251396|NCT01388816|B1|Baseline|Placebo Capsule|Once daily after breakfast
251397|NCT01388816|P4|Participant Flow|DRL-17822 300 mg|Once daily after breakfast
251398|NCT01388816|P3|Participant Flow|DRL-17822 150 mg|Once daily after breakfast
251399|NCT01388816|P2|Participant Flow|DRL-17822 50 mg|Once daily after breakfast
251400|NCT01388816|P1|Participant Flow|Placebo|Once daily after breakfast
251401|NCT01388816|O4|Outcome|DRL-17822 300 mg|Once daily after breakfast
251402|NCT01388816|O3|Outcome|DRL-17822 150 mg|Once daily after breakfast
251403|NCT01388816|O2|Outcome|DRL-17822 50 mg|Once daily after breakfast
251404|NCT01388816|O1|Outcome|Placebo Capsule|Once daily after breakfast
251405|NCT01388816|O4|Outcome|DRL-17822 300 mg|Once daily after breakfast
251406|NCT01388816|O3|Outcome|DRL-17822 150 mg|Once daily after breakfast
251407|NCT01388816|O2|Outcome|DRL-17822 50 mg|Once daily after breakfast
251408|NCT01388816|O1|Outcome|Placebo Capsule|Once daily after breakfast
251409|NCT01388816|O3|Outcome|DRL-17822 300 mg|Once daily after breakfast
251410|NCT01388816|O2|Outcome|DRL-17822 150 mg|Once daily after breakfast
251411|NCT01388816|O1|Outcome|DRL-17822 50 mg|Once daily after breakfast
251412|NCT01388816|O4|Outcome|DRL-17822 300 mg|Once daily after breakfast
251413|NCT01388816|O3|Outcome|DRL-17822 150 mg|Once daily after breakfast
251414|NCT01388816|O2|Outcome|DRL-17822 50 mg|Once daily after breakfast
251415|NCT01388816|O1|Outcome|Placebo Capsule|Once daily after breakfast
251416|NCT01388816|O4|Outcome|DRL-17822 300 mg|Once daily after breakfast
251417|NCT01388816|O3|Outcome|DRL-17822 150 mg|Once daily after breakfast
251418|NCT01388816|O2|Outcome|DRL-17822 50 mg|Once daily after breakfast
251419|NCT01388816|O1|Outcome|Placebo Capsule|Once daily after breakfast
251420|NCT01388816|O4|Outcome|DRL-17822 300 mg|Once daily after breakfast
251421|NCT01388816|O3|Outcome|DRL-17822 150 mg|Once daily after breakfast
251422|NCT01388816|O2|Outcome|DRL-17822 50 mg|Once daily after breakfast
251423|NCT01388816|O1|Outcome|Placebo Capsule|Once daily after breakfast
251424|NCT01388816|E4|Reported Event|DRL-17822 300 mg|Once daily after breakfast
251425|NCT01388816|E3|Reported Event|DRL-17822 150 mg|Once daily after breakfast
251426|NCT01388816|E2|Reported Event|DRL-17822 50 mg|Once daily after breakfast
251427|NCT01388816|E1|Reported Event|Placebo Capsule|Once daily after breakfast
251428|NCT01388790|B1|Baseline|Cetuximab Plus Cisplatin Plus S-1|Cetuximab once weekly (initial dose 400 milligram per square meter [mg/m^2] followed by subsequent 250 mg/m^2 intravenous infusion), cisplatin (60 mg/m^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
251429|NCT01388790|P1|Participant Flow|Cetuximab Plus Cisplatin Plus S-1|Cetuximab once weekly (initial dose 400 milligram per square meter [mg/m^2] followed by subsequent 250 mg/m^2 intravenous infusion), cisplatin (60 mg/m^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
251430|NCT01388790|O1|Outcome|Cetuximab Plus Cisplatin Plus S-1|Cetuximab once weekly (initial dose 400 milligram per square meter [mg/m^2] followed by subsequent 250 mg/m^2 intravenous infusion), cisplatin (60 mg/m^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
251431|NCT01388790|O1|Outcome|Cetuximab Plus Cisplatin Plus S-1|Cetuximab once weekly (initial dose 400 milligram per square meter [mg/m^2] followed by subsequent 250 mg/m^2 intravenous infusion), cisplatin (60 mg/m^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
251432|NCT01388790|E1|Reported Event|Cetuximab Plus Cisplatin Plus S-1|Cetuximab once weekly (initial dose 400 milligram per square meter [mg/m^2] followed by subsequent 250 mg/m^2 intravenous infusion), cisplatin (60 mg/m^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
251433|NCT01388647|B3|Baseline|Total|Total of all reporting groups
251434|NCT01388647|B2|Baseline|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
251435|NCT01388647|B1|Baseline|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
251436|NCT01388647|P2|Participant Flow|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
251437|NCT01388647|P1|Participant Flow|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
251438|NCT01388647|O2|Outcome|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
251439|NCT01388647|O1|Outcome|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
251440|NCT01388647|O1|Outcome|All Study Participants|All subjects were assigned to receive either a starting dose of eribulin 1.1 mg/m^2 or eribulin 1.4 mg/m^2.
251441|NCT01388647|O2|Outcome|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
251442|NCT01388647|O1|Outcome|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
251443|NCT01388647|O2|Outcome|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
251444|NCT01388647|O1|Outcome|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
251445|NCT01388647|E2|Reported Event|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
251446|NCT01388647|E1|Reported Event|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
251447|NCT01388530|B1|Baseline|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.~EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
251448|NCT01388530|P1|Participant Flow|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.~EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
251449|NCT01388530|O1|Outcome|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.~EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
251450|NCT01388530|O1|Outcome|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.~EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
251451|NCT01388530|O1|Outcome|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.~EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
251452|NCT01388530|O1|Outcome|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.~EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
251453|NCT01388530|E1|Reported Event|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.~EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
251454|NCT01388491|B3|Baseline|Total|Total of all reporting groups
251455|NCT01388491|B2|Baseline|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
251456|NCT01388491|B1|Baseline|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
251457|NCT01388491|P2|Participant Flow|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
251458|NCT01388491|P1|Participant Flow|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
251459|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
251460|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
251841|NCT01386606|O1|Outcome|Androxal 6.25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
251461|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
251462|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
251463|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
251464|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
251465|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
251466|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
251467|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
251468|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
251469|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
251470|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
251471|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
251472|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
251473|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
251474|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
251475|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
251476|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
251477|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
251478|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
251479|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
251480|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
251481|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
251482|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
251483|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
251484|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
251485|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
251486|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
251487|NCT01388491|E2|Reported Event|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
251488|NCT01388491|E1|Reported Event|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
251489|NCT01388361|B4|Baseline|Total|Total of all reporting groups
251490|NCT01388361|B3|Baseline|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
251491|NCT01388361|B2|Baseline|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
251492|NCT01388361|B1|Baseline|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
251493|NCT01388361|P3|Participant Flow|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
251494|NCT01388361|P2|Participant Flow|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
251495|NCT01388361|P1|Participant Flow|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
251496|NCT01388361|O3|Outcome|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
251497|NCT01388361|O2|Outcome|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
251498|NCT01388361|O1|Outcome|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
251499|NCT01388361|O3|Outcome|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
251500|NCT01388361|O2|Outcome|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
251501|NCT01388361|O1|Outcome|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
251502|NCT01388361|O3|Outcome|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
251503|NCT01388361|O2|Outcome|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
251504|NCT01388361|O1|Outcome|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
251505|NCT01388361|O3|Outcome|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
251506|NCT01388361|O2|Outcome|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
251540|NCT01387672|B5|Baseline|0.6 Sublingual (Nitrostat 2) - Treatment Arm 5|"Nitroglycerin 0.6mg Sublingual Tablet~Nitrates (NABT Main trial)"
268763|NCT01334554|O2|Outcome|Placebo|"placebo~Placebo: No active drug"
251507|NCT01388361|O1|Outcome|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
251508|NCT01388361|E3|Reported Event|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
251509|NCT01388361|E2|Reported Event|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
251510|NCT01388361|E1|Reported Event|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
251511|NCT01388166|B1|Baseline|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
251512|NCT01388166|P1|Participant Flow|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
251513|NCT01388166|O1|Outcome|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
251514|NCT01388166|O1|Outcome|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
251515|NCT01388166|O1|Outcome|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
251516|NCT01388166|E1|Reported Event|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) at least 1 months and within product label.
251517|NCT01387789|B1|Baseline|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
251518|NCT01387789|P1|Participant Flow|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
251519|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
251520|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
251521|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
251522|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
251523|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
251524|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
251525|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
251526|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
251527|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
251528|NCT01387789|E1|Reported Event|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
251529|NCT01387737|B3|Baseline|Total|Total of all reporting groups
251530|NCT01387737|B2|Baseline|TA-7284-High|TA-7284 high dose, once daily for 52 weeks
251531|NCT01387737|B1|Baseline|TA-7284-Low|TA-7284 low dose, once daily for 52 weeks
251532|NCT01387737|P2|Participant Flow|TA-7284-High|TA-7284 high dose, once daily for 52 weeks
251533|NCT01387737|P1|Participant Flow|TA-7284-Low|TA-7284 low dose, once daily for 52 weeks
251534|NCT01387737|O2|Outcome|TA-7284-High|TA-7284 high dose, once daily for 52 weeks
251535|NCT01387737|O1|Outcome|TA-7284-Low|TA-7284 low dose, once daily for 52 weeks
251536|NCT01387737|E2|Reported Event|TA-7284-High|TA-7284 high dose, once daily for 52 weeks
251537|NCT01387737|E1|Reported Event|TA-7284-Low|TA-7284 low dose, once daily for 52 weeks
251538|NCT01387672|B7|Baseline|Total|Total of all reporting groups
251539|NCT01387672|B6|Baseline|Placebo Ointment - Treatment Arm 6|"Placebo Ointment~Placebo: Placebo ointment Nitrates (NABT Main trial)"
251900|NCT01385995|P2|Participant Flow|Sham-Continuous Positive Airway Pressure|
251541|NCT01387672|B4|Baseline|0.3 Sublingual (Nitrostat 1) - Treatment Arm 4|"Nitroglycerin 0.3mg Sublingual Tablet~Nitrates (NABT Main trial)"
251542|NCT01387672|B3|Baseline|Ointment (Nitrol) - Treatment Arm 3|"Nitroglycerin Ointment 2% USP~Nitrates (NABT Main trial)"
251543|NCT01387672|B2|Baseline|Patch (Nitro-Dur) - Treatment Arm 2|"Nitroglycerin Extended Release Patch 160mg~Nitrates (NABT Main trial)"
251544|NCT01387672|B1|Baseline|ISMO - Treatment Arm 1|"Isosorbide Mononitrate 20mg Oral Tablet~Nitrates (NABT Main trial)"
251545|NCT01387672|P6|Participant Flow|Placebo Ointment - Treatment Arm 6|"Placebo Ointment~Nitrates (NABT Main trial)"
251546|NCT01387672|P5|Participant Flow|0.6 Sublingual (Nitrostat 2) - Treatment Arm 5|"Nitroglycerin 0.6mg Sublingual Tablet~Nitrates (NABT Main trial)"
251547|NCT01387672|P4|Participant Flow|0.3 Sublingual (Nitrostat 1) - Treatment Arm 4|"Nitroglycerin 0.3mg Sublingual Tablet~Nitrates (NABT Main trial)"
251548|NCT01387672|P3|Participant Flow|Ointment (Nitrol) - Treatment Arm 3|"Nitroglycerin Ointment 2% USP~Nitrates (NABT Main trial)"
251549|NCT01387672|P2|Participant Flow|Patch (Nitro-Dur) - Treatment Arm 2|"Nitroglycerin Extended Release Patch 160mg~Nitrates (NABT Main trial)"
251550|NCT01387672|P1|Participant Flow|ISMO - Treatment Arm 1|"Isosorbide Mononitrate 20mg Oral Tablet~Nitrates (NABT Main trial)"
251551|NCT01387672|O1|Outcome|Run-in Phase|During the run-in phase subjects received, in random order, each of the 5 nitrate formulations for 2 days with a 2 day wash out period between formulations. The severity of headaches was recorded, by subjects, upon awakening, every day during the run in phase using a visual analog scale (VAS).
251552|NCT01387672|O6|Outcome|Placebo Ointment - Treatment Arm 6|"Placebo Ointment~Placebo: Placebo ointment Nitrates (NABT Main trial)"
251553|NCT01387672|O5|Outcome|0.6 Sublingual (Nitrostat 2) - Treatment Arm 5|"Nitroglycerin 0.6mg Sublingual Tablet~Nitrates (NABT Main trial)"
251554|NCT01387672|O4|Outcome|0.3 Sublingual (Nitrostat 1) - Treatment Arm 4|"Nitroglycerin 0.3mg Sublingual Tablet~Nitrates (NABT Main trial)"
251555|NCT01387672|O3|Outcome|Ointment (Nitrol) - Treatment Arm 3|"Nitroglycerin Ointment 2% USP~Nitrates (NABT Main trial)"
251556|NCT01387672|O2|Outcome|Patch (Nitro-Dur) - Treatment Arm 2|"Nitroglycerin Extended Release Patch 160mg~Nitrates (NABT Main trial)"
251557|NCT01387672|O1|Outcome|ISMO - Treatment Arm 1|"Isosorbide Mononitrate 20mg Oral Tablet~Nitrates (NABT Main trial)"
251558|NCT01387672|E6|Reported Event|Placebo Ointment- Treatment Arm 6|"Placebo Ointment~Placebo: Placebo ointment Nitrates (NABT Main trial)"
251559|NCT01387672|E5|Reported Event|0.6 Sublingual (Nitrostat 2) - Treatment Arm 5|"Nitroglycerin 0.6mg Sublingual Tablet~Nitrates (NABT Main trial)"
251560|NCT01387672|E4|Reported Event|0.3 Sublingual (Nitrostat 1) - Treatment Arm 4|"Nitroglycerin 0.3mg Sublingual Tablet~Nitrates (NABT Main trial)"
251561|NCT01387672|E3|Reported Event|Ointment (Nitrol) - Treatment Arm 3|"Nitroglycerin Ointment 2% USP~Nitrates (NABT Main trial)"
251562|NCT01387672|E2|Reported Event|Patch (Nitro-Dur) - Treatment Arm 2|"Nitroglycerin Extended Release Patch 160mg~Nitrates (NABT Main trial)"
251563|NCT01387672|E1|Reported Event|ISMO - Treatment Arm 1|"Isosorbide Mononitrate 20mg Oral Tablet~Nitrates (NABT Main trial)"
251564|NCT01387594|B3|Baseline|Total|Total of all reporting groups
251565|NCT01387594|B2|Baseline|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
251566|NCT01387594|B1|Baseline|Cohort 1: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Prior to treatment, participants underwent 2 lumbar punctures (LP) 2-4 weeks apart. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
251567|NCT01387594|P2|Participant Flow|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
251568|NCT01387594|P1|Participant Flow|Cohort 1: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Prior to treatment, participants underwent 2 lumbar punctures (LP) 2-4 weeks apart. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
251569|NCT01387594|O2|Outcome|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
251570|NCT01387594|O1|Outcome|Cohort 1: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Prior to treatment, participants underwent 2 lumbar punctures (LP) 2-4 weeks apart. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
251593|NCT01387581|E2|Reported Event|With MelaFind|Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
251594|NCT01387581|E1|Reported Event|Without MelaFind|Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
251571|NCT01387594|O2|Outcome|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
251572|NCT01387594|O1|Outcome|Cohort 1: PF-00547659|Participants who had Crohns disease (CD) and who satisfied all study entry criteria were enrolled into the study. Prior to treatment, participants underwent 2 lumbar punctures (LP) 2-4 weeks apart. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
251573|NCT01387594|O2|Outcome|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
251574|NCT01387594|O1|Outcome|Cohort 1: PF-00547659|Participants who had CD and who satisfied all study entry criteria were enrolled into the study. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). 2 LPs were to be performed during participation. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
251575|NCT01387594|O1|Outcome|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
251576|NCT01387594|O1|Outcome|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
251577|NCT01387594|E2|Reported Event|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
251578|NCT01387594|E1|Reported Event|Cohort 1: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Prior to treatment, participants underwent 2 lumbar punctures (LP) 2-4 weeks apart. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
251579|NCT01387581|B4|Baseline|Total|Total of all reporting groups
251580|NCT01387581|B3|Baseline|Experts Without MelaFind|PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
251581|NCT01387581|B2|Baseline|With MelaFind|Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
251582|NCT01387581|B1|Baseline|Without MelaFind|Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
251583|NCT01387581|P3|Participant Flow|Experts Without MelaFind|PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
251584|NCT01387581|P2|Participant Flow|With MelaFind|Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
251585|NCT01387581|P1|Participant Flow|Without MelaFind|Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
251586|NCT01387581|O3|Outcome|Experts Without MelaFind|PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
251587|NCT01387581|O2|Outcome|With MelaFind|Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
251588|NCT01387581|O1|Outcome|Without MelaFind|Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
251589|NCT01387581|O3|Outcome|Experts Without MelaFind|PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
251590|NCT01387581|O2|Outcome|With MelaFind|Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
251591|NCT01387581|O1|Outcome|Without MelaFind|Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
251592|NCT01387581|E3|Reported Event|Experts Without MelaFind|PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
251595|NCT01387542|B1|Baseline|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
251596|NCT01387542|P1|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
251597|NCT01387542|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
251598|NCT01387542|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
251599|NCT01387542|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
251600|NCT01387542|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
251601|NCT01387542|E1|Reported Event|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
251602|NCT01387464|B3|Baseline|Total|Total of all reporting groups
251603|NCT01387464|B2|Baseline|Bromday|0.09% bromfenac dosed QD
251604|NCT01387464|B1|Baseline|ISV-303|0.075% bromfenac in DuraSite vehicle dosed QD
251605|NCT01387464|P2|Participant Flow|Bromday|0.09% bromfenac dosed QD
251606|NCT01387464|P1|Participant Flow|ISV-303|0.075% bromfenac in DuraSite vehicle dosed QD
251607|NCT01387464|O2|Outcome|Bromday|0.09% bromfenac dosed QD
251608|NCT01387464|O1|Outcome|ISV-303|0.075% bromfenac in DuraSite vehicle dosed QD
251609|NCT01387464|E2|Reported Event|Bromday|0.09% bromfenac dosed QD
251610|NCT01387464|E1|Reported Event|ISV-303|0.075% bromfenac in DuraSite vehicle dosed QD
251611|NCT01387347|B3|Baseline|Total|Total of all reporting groups
251612|NCT01387347|B2|Baseline|Thymosin Beta 4|"RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4~Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
251613|NCT01387347|B1|Baseline|Placebo|"The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.~Placebo : A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
251614|NCT01387347|P2|Participant Flow|Thymosin Beta 4|"RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4.~Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
251615|NCT01387347|P1|Participant Flow|Placebo|"The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.~Placebo : A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
251616|NCT01387347|O2|Outcome|Thymosin Beta 4|RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye twice a day for 29 days.
251617|NCT01387347|O1|Outcome|Placebo|Placebo is a preservative-free, sterile eye drop solution containing 0% Tβ4 (w/w) for direct instillation into each eye twice a day for 29 days.
251618|NCT01387347|O2|Outcome|Thymosin Beta 4|Thymosin beta 4 solution is a sterile eye drop solution containing 0.1%(w/w) Tβ4. Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.
251619|NCT01387347|O1|Outcome|Placebo|"The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.~Placebo : A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
251620|NCT01387347|O2|Outcome|Placebo|Placebo is a preservative-free, sterile eye drop solution containing 0% Tβ4 Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0% Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.
251621|NCT01387347|O1|Outcome|Thymosin Beta 4|RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.
251622|NCT01387347|E2|Reported Event|Thymosin Beta 4|"RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4~Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
251623|NCT01387347|E1|Reported Event|Placebo|"The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.~Placebo : A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
251624|NCT01387282|B3|Baseline|Total|Total of all reporting groups
251625|NCT01387282|B2|Baseline|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251626|NCT01387282|B1|Baseline|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251627|NCT01387282|P2|Participant Flow|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251628|NCT01387282|P1|Participant Flow|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251629|NCT01387282|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251630|NCT01387282|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
269056|NCT01333397|O3|Outcome|Dysport NG 50 U|
251631|NCT01387282|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251632|NCT01387282|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251633|NCT01387282|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251634|NCT01387282|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251635|NCT01387282|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251636|NCT01387282|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251637|NCT01387282|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251638|NCT01387282|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251639|NCT01387282|E2|Reported Event|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251640|NCT01387282|E1|Reported Event|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251641|NCT01387269|B3|Baseline|Total|Total of all reporting groups
251642|NCT01387269|B2|Baseline|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251643|NCT01387269|B1|Baseline|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251644|NCT01387269|P2|Participant Flow|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251645|NCT01387269|P1|Participant Flow|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251646|NCT01387269|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251647|NCT01387269|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251648|NCT01387269|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251649|NCT01387269|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251650|NCT01387269|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251651|NCT01387269|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251652|NCT01387269|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251653|NCT01387269|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251654|NCT01387269|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251655|NCT01387269|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251656|NCT01387269|E2|Reported Event|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251657|NCT01387269|E1|Reported Event|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
251658|NCT01387230|B4|Baseline|Total|Total of all reporting groups
251659|NCT01387230|B3|Baseline|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
251660|NCT01387230|B2|Baseline|UMEC 62.5 µg|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
251661|NCT01387230|B1|Baseline|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
251662|NCT01387230|P3|Participant Flow|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
251663|NCT01387230|P2|Participant Flow|UMEC 62.5 µg QD|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) QD via a DPI in the morning for 12 weeks.
251664|NCT01387230|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 12 weeks.
251665|NCT01387230|O3|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
251666|NCT01387230|O2|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
251667|NCT01387230|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
251668|NCT01387230|O3|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
251669|NCT01387230|O2|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
251670|NCT01387230|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
251671|NCT01387230|O3|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
251672|NCT01387230|O2|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
251673|NCT01387230|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
251674|NCT01387230|E3|Reported Event|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
251901|NCT01385995|P1|Participant Flow|Continuous Positive Airway Pressure (CPAP)|
251678|NCT01387178|B2|Baseline|Tiotropium Bromide 18 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for TIO
251679|NCT01387178|B1|Baseline|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC
251680|NCT01387178|P2|Participant Flow|Tiotropium Bromide 18 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for tiotropium bromide (TIO)
251681|NCT01387178|P1|Participant Flow|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Edition, Clinical Modification [ICD-9-CM] code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for fluticasone/propionate 250 µg /50 µg (FSC)
251682|NCT01387178|O2|Outcome|Tiotropium Bromide 18 µg|Participants 40 years of age or older with &gt;=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), &gt;=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), &gt;=1 in the post-index date observation period, and &gt;=1 prescription claim for TIO
251683|NCT01387178|O1|Outcome|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC
251684|NCT01387178|O2|Outcome|Tiotropium Bromide 18 µg|Participants 40 years of age or older with &gt;=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), &gt;=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), &gt;=1 in the post-index date observation period, and &gt;=1 prescription claim for TIO
251685|NCT01387178|O1|Outcome|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC
251686|NCT01387178|O2|Outcome|Tiotropium Bromide 18 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for TIO
251687|NCT01387178|O1|Outcome|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC
251688|NCT01387178|E2|Reported Event|Tiotropium Bromide 18 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for TIO
251689|NCT01387178|E1|Reported Event|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC
251690|NCT01387139|B3|Baseline|Total|Total of all reporting groups
251691|NCT01387139|B2|Baseline|Ketamine Co-Administered With Propofol|
251692|NCT01387139|B1|Baseline|Ketamine Alone|
251693|NCT01387139|P2|Participant Flow|Ketamine Co-Administered With Propofol|Ketamine Co-administered with Propofol: 0.5 mg/kg ketamine and 0.5 mg/kg propofol with additional doses of 0.25 mg/kg ketamine and 0.25 mg/kg propofol as needed (maximum single dose based on 100 kg person)
251694|NCT01387139|P1|Participant Flow|Ketamine Alone|Ketamine: 1.0 milligrams/kilogram (mg/kg) ketamine with additional doses of 0.5 mg/kg ketamine as needed (maximum single dose based on 100 kilogram (kg) person)
251695|NCT01387139|O2|Outcome|Ketamine Co-Administered With Propofol|
251696|NCT01387139|O1|Outcome|Ketamine Alone|
251697|NCT01387139|O2|Outcome|Ketamine Co-Administered With Propofol|
251698|NCT01387139|O1|Outcome|Ketamine Alone|
251699|NCT01387139|O2|Outcome|Ketamine Co-Administered With Propofol|
251700|NCT01387139|O1|Outcome|Ketamine Alone|
251701|NCT01387139|O2|Outcome|Ketamine Co-Administered With Propofol|
251702|NCT01387139|O1|Outcome|Ketamine Alone|
251703|NCT01387139|O2|Outcome|Ketamine Co-Administered With Propofol|
251704|NCT01387139|O1|Outcome|Ketamine Alone|
251705|NCT01387139|O2|Outcome|Ketamine Co-Administered With Propofol|
251706|NCT01387139|O1|Outcome|Ketamine Alone|
251707|NCT01387139|E2|Reported Event|Ketamine Co-Administered With Propofol|
251708|NCT01387139|E1|Reported Event|Ketamine Alone|
251709|NCT01387074|B1|Baseline|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
251902|NCT01385995|O2|Outcome|Sham CPAP|
251710|NCT01387074|P1|Participant Flow|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
251711|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
251712|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
251713|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
251714|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
251715|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
251716|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
251717|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
251718|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
251719|NCT01387074|E1|Reported Event|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
251720|NCT01387022|B3|Baseline|Total|Total of all reporting groups
251721|NCT01387022|B2|Baseline|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
251722|NCT01387022|B1|Baseline|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
251723|NCT01387022|P2|Participant Flow|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
251724|NCT01387022|P1|Participant Flow|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
251725|NCT01387022|O2|Outcome|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
251726|NCT01387022|O1|Outcome|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
251727|NCT01387022|O2|Outcome|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
251728|NCT01387022|O1|Outcome|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
251729|NCT01387022|O2|Outcome|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
251730|NCT01387022|O1|Outcome|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
251731|NCT01387022|O2|Outcome|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
251732|NCT01387022|O1|Outcome|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
251733|NCT01387022|O2|Outcome|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
251734|NCT01387022|O1|Outcome|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
251735|NCT01387022|O2|Outcome|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
251736|NCT01387022|O1|Outcome|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
251737|NCT01387022|E2|Reported Event|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
251738|NCT01387022|E1|Reported Event|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
251739|NCT01386983|B3|Baseline|Total|Total of all reporting groups
251740|NCT01386983|B2|Baseline|Delayed Cohort|Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
251741|NCT01386983|B1|Baseline|Early Cohort|Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users)
251742|NCT01386983|P2|Participant Flow|Delayed Cohort|Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
251743|NCT01386983|P1|Participant Flow|Early Cohort|Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users)
251744|NCT01386983|O2|Outcome|Delayed Cohort|Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
251745|NCT01386983|O1|Outcome|Early Cohort|Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users)
251746|NCT01386983|O2|Outcome|Delayed Cohort|Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
251747|NCT01386983|O1|Outcome|Early Cohort|Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users)
251748|NCT01386983|E2|Reported Event|Delayed Cohort|Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
251749|NCT01386983|E1|Reported Event|Early Cohort|Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users)
251750|NCT01386944|B1|Baseline|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
251751|NCT01386944|P1|Participant Flow|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
251752|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
251753|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
251754|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
251755|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
251756|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
251757|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
251758|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
251759|NCT01386944|E1|Reported Event|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
251760|NCT01386788|B1|Baseline|Smoke Inhalation Victims|Smoke inhalation victims included civil victims and fire workers as specified in the inclusion criteria were observed.
251761|NCT01386788|P1|Participant Flow|Smoke Inhalation Victims|Smoke inhalation victims included civil victims and fire workers as specified in the inclusion criteria were observed.
251762|NCT01386788|O1|Outcome|Smoke Inhalation Victims|Smoke inhalation victims included civil victims and fire workers as specified in the inclusion criteria were observed.
251763|NCT01386788|O1|Outcome|Smoke Inhalation Victims|Smoke inhalation victims included civil victims and fire workers as specified in the inclusion criteria were observed.
251764|NCT01386788|E1|Reported Event|Smoke Inhalation Victim|Smoke inhalation victims included civil victims and fire workers as specified in the inclusion criteria were observed
251765|NCT01386684|B1|Baseline|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251766|NCT01386684|P1|Participant Flow|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251767|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251768|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251769|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251770|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251771|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251772|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251773|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251774|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251775|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251776|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251777|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251778|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251779|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251780|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251781|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251782|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251783|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251784|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251785|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251786|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251787|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251788|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251789|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251790|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251791|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251792|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251793|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251794|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251795|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251796|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251797|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251798|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251799|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251800|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251801|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251802|NCT01386684|O1|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251803|NCT01386684|E1|Reported Event|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
251804|NCT01386632|B3|Baseline|Total|Total of all reporting groups
251805|NCT01386632|B2|Baseline|Placebo|Placebo: Placebo PO or per G-tube twice a day for 8 weeks given in combination with Cisplatin.
251806|NCT01386632|B1|Baseline|DCA (Dichloroacetate) Treatment|"DCA orally 12.5mg/kg or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60 minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)~DCA (dichloroacetate): DCA orally 12.5mg/kg PO or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)"
251807|NCT01386632|P2|Participant Flow|Placebo|Placebo: Placebo PO or per G-tube twice a day for 8 weeks given in combination with Cisplatin.
251808|NCT01386632|P1|Participant Flow|DCA (Dichloroacetate) Treatment|"DCA orally 12.5mg/kg or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60 minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)~DCA (dichloroacetate): DCA orally 12.5mg/kg PO or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)"
251809|NCT01386632|O2|Outcome|Placebo|Placebo: Placebo PO or per G-tube twice a day for 8 weeks given in combination with Cisplatin.
251810|NCT01386632|O1|Outcome|DCA (Dichloroacetate) Treatment|"DCA orally 12.5mg/kg or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60 minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)~DCA (dichloroacetate): DCA orally 12.5mg/kg PO or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)"
251811|NCT01386632|O2|Outcome|Placebo|Placebo: Placebo PO or per G-tube twice a day for 8 weeks given in combination with Cisplatin.
251812|NCT01386632|O1|Outcome|DCA (Dichloroacetate) Treatment|"DCA orally 12.5mg/kg or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60 minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)~DCA (dichloroacetate): DCA orally 12.5mg/kg PO or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)"
251813|NCT01386632|E2|Reported Event|Placebo|Placebo: Placebo PO or per G-tube twice a day for 8 weeks given in combination with Cisplatin.
251814|NCT01386632|E1|Reported Event|DCA (Dichloroacetate) Treatment|"DCA orally 12.5mg/kg or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60 minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)~DCA (dichloroacetate): DCA orally 12.5mg/kg PO or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)"
251815|NCT01386606|B5|Baseline|Total|Total of all reporting groups
251816|NCT01386606|B4|Baseline|AndroGel|"AndroGel 5G topical testosterone~Testosterone: topical gel~1X a day 6 weeks"
251817|NCT01386606|B3|Baseline|Androxal 25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
251818|NCT01386606|B2|Baseline|Androxal 12.5 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
251819|NCT01386606|B1|Baseline|Androxal 6.25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
251820|NCT01386606|P4|Participant Flow|AndroGel|"AndroGel 5G topical testosterone~Testosterone: topical gel~1X a day 6 weeks"
251821|NCT01386606|P3|Participant Flow|Androxal 25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
251822|NCT01386606|P2|Participant Flow|Androxal 12.5 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
251823|NCT01386606|P1|Participant Flow|Androxal 6.25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
251824|NCT01386606|O3|Outcome|Androxal 25 mg|"Androxal 25 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
251825|NCT01386606|O2|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
251826|NCT01386606|O1|Outcome|Androxal 6.25 mg|"Androxal 6.25 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
251827|NCT01386606|O3|Outcome|Androxal 25 mg|"Androxal 25 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
251828|NCT01386606|O2|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
251829|NCT01386606|O1|Outcome|Androxal 6.25 mg|"Androxal 6.25 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
251830|NCT01386606|O4|Outcome|AndroGel|"AndroGel 5G topical testosterone~Testosterone: topical gel~1X a day 6 weeks"
251831|NCT01386606|O3|Outcome|Androxal 25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
251832|NCT01386606|O2|Outcome|Androxal 12.5 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
251833|NCT01386606|O1|Outcome|Androxal 6.25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
251834|NCT01386606|O3|Outcome|Androxal 25 mg|"Androxal 25 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
251835|NCT01386606|O2|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
251836|NCT01386606|O1|Outcome|Androxal 6.25 mg|"Androxal 6.25 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
251837|NCT01386606|O1|Outcome|Androxal Pooled Dose Levels|Androxal 6.25, 12.5, and 25 mg subjects combined into a single group.
251838|NCT01386606|O4|Outcome|AndroGel|"AndroGel 5G topical testosterone~Testosterone: topical gel~1X a day 6 weeks"
251839|NCT01386606|O3|Outcome|Androxal 25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
251840|NCT01386606|O2|Outcome|Androxal 12.5 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
251842|NCT01386606|O4|Outcome|AndroGel|"AndroGel 5G topical testosterone~Testosterone: topical gel~1X a day 6 weeks"
251843|NCT01386606|O3|Outcome|Androxal 25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
251844|NCT01386606|O2|Outcome|Androxal 12.5 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
251845|NCT01386606|O1|Outcome|Androxal 6.25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
251846|NCT01386606|E4|Reported Event|AndroGel|"AndroGel 5G topical testosterone~Testosterone: topical gel~1X a day 6 weeks"
251847|NCT01386606|E3|Reported Event|Androxal 25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
251848|NCT01386606|E2|Reported Event|Androxal 12.5 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
251849|NCT01386606|E1|Reported Event|Androxal 6.25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
251850|NCT01386554|B4|Baseline|Total|Total of all reporting groups
251851|NCT01386554|B3|Baseline|Placbeo|Placebo
251852|NCT01386554|B2|Baseline|Acthar 80U|80 units (U) of Acthar administered 2 times a week
251853|NCT01386554|B1|Baseline|Acthar 40U|40 units (U) of Acthar administered 5 times a week
251854|NCT01386554|P3|Participant Flow|Placbeo|Placebo
251855|NCT01386554|P2|Participant Flow|Acthar 80U|80 units (U) of Acthar administered 2 times a week
251856|NCT01386554|P1|Participant Flow|Acthar 40U|40 units (U) of Acthar administered 5 times a week
251857|NCT01386554|O3|Outcome|Placbeo|Placebo
251858|NCT01386554|O2|Outcome|Acthar 80U|80 units (U) of Acthar administered 2 times a week
251859|NCT01386554|O1|Outcome|Acthar 40U|40 units (U) of Acthar administered 5 times a week
251860|NCT01386554|O3|Outcome|Placbeo|Placebo
251861|NCT01386554|O2|Outcome|Acthar 80U|80 units (U) of Acthar administered 2 times a week
251862|NCT01386554|O1|Outcome|Acthar 40U|40 units (U) of Acthar administered 5 times a week
251863|NCT01386554|O3|Outcome|Placbeo|Placebo
251864|NCT01386554|O2|Outcome|Acthar 80U|80 units (U) of Acthar administered 2 times a week
251865|NCT01386554|O1|Outcome|Acthar 40U|40 units (U) of Acthar administered 5 times a week
251866|NCT01386554|E3|Reported Event|Placbeo|Placebo
251867|NCT01386554|E2|Reported Event|Acthar 80U|80 units (U) of Acthar administered 2 times a week
251868|NCT01386554|E1|Reported Event|Acthar 40U|40 units (U) of Acthar administered 5 times a week
251869|NCT01386528|B1|Baseline|Nonacog Beta Pegol|New patients as well as transferred patients from the pivotal trial (NN7999-3747) or the extension trial(NN7999-3775) received nonacog beta pegol at screening and followed a preventive treatment regimen with nonacog beta pegol until one week before the day of surgery. No more than 4 hours prior to the planned surgical procedure, all patients received a single bolus injection of 80 U/kg of nonacog beta pegol. Postoperatively, the patients received fixed doses of 40 U/kg repeated at the investigator’s discretion aiming for no less than the FIX levels recommended by the World Federation of Hemophilia. Nonacog beta pegol was administered intravenously. The new patients were dosed once with 40 U/kg nonacog beta pegol at screening.From the day after surgery (Day 1) and through Day 6, nonacog beta pegol dosing was adjusted to aim for a FIX activity level of approximately 0.50 U/mL.
251870|NCT01386528|P1|Participant Flow|Nonacog Beta Pegol|New patients as well as transferred patients from the pivotal trial (NN7999-3747) or the extension trial(NN7999-3775) received nonacog beta pegol at screening and followed a preventive treatment regimen with nonacog beta pegol until one week before the day of surgery. No more than 4 hours prior to the planned surgical procedure, all patients received a single bolus injection of 80 U/kg of nonacog beta pegol. Postoperatively, the patients received fixed doses of 40 U/kg repeated at the investigator’s discretion aiming for no less than the FIX levels recommended by the World Federation of Hemophilia. Nonacog beta pegol was administered intravenously. The new patients were dosed once with 40 U/kg nonacog beta pegol at screening.From the day after surgery (Day 1) and through Day 6, nonacog beta pegol dosing was adjusted to aim for a FIX activity level of approximately 0.50 U/mL.
251871|NCT01386528|O1|Outcome|Nonacog Beta Pegol|New patients as well as transferred patients from the pivotal trial (NN7999-3747) or the extension trial(NN7999-3775) received nonacog beta pegol at screening and followed a preventive treatment regimen with nonacog beta pegol until one week before the day of surgery. No more than 4 hours prior to the planned surgical procedure, all patients received a single bolus injection of 80 U/kg of nonacog beta pegol. Postoperatively, the patients received fixed doses of 40 U/kg repeated at the investigator’s discretion aiming for no less than the FIX levels recommended by the World Federation of Hemophilia. Nonacog beta pegol was administered intravenously. The new patients were dosed once with 40 U/kg nonacog beta pegol at screening.From the day after surgery (Day 1) and through Day 6, nonacog beta pegol dosing was adjusted to aim for a FIX activity level of approximately 0.50 U/mL.
251872|NCT01386528|O1|Outcome|Nonacog Beta Pegol|New patients as well as transferred patients from the pivotal trial (NN7999-3747) or the extension trial(NN7999-3775) received nonacog beta pegol at screening and followed a preventive treatment regimen with nonacog beta pegol until one week before the day of surgery. No more than 4 hours prior to the planned surgical procedure, all patients received a single bolus injection of 80 U/kg of nonacog beta pegol. Postoperatively, the patients received fixed doses of 40 U/kg repeated at the investigator’s discretion aiming for no less than the FIX levels recommended by the World Federation of Hemophilia. Nonacog beta pegol was administered intravenously. The new patients were dosed once with 40 U/kg nonacog beta pegol at screening.From the day after surgery (Day 1) and through Day 6, nonacog beta pegol dosing was adjusted to aim for a FIX activity level of approximately 0.50 U/mL.
251873|NCT01386528|O1|Outcome|Nonacog Beta Pegol|New patients as well as transferred patients from the pivotal trial (NN7999-3747) or the extension trial(NN7999-3775) received nonacog beta pegol at screening and followed a preventive treatment regimen with nonacog beta pegol until one week before the day of surgery. No more than 4 hours prior to the planned surgical procedure, all patients received a single bolus injection of 80 U/kg of nonacog beta pegol. Postoperatively, the patients received fixed doses of 40 U/kg repeated at the investigator’s discretion aiming for no less than the FIX levels recommended by the World Federation of Hemophilia. Nonacog beta pegol was administered intravenously. The new patients were dosed once with 40 U/kg nonacog beta pegol at screening.From the day after surgery (Day 1) and through Day 6, nonacog beta pegol dosing was adjusted to aim for a FIX activity level of approximately 0.50 U/mL.
251903|NCT01385995|O1|Outcome|Therapeutic CPAP|
251904|NCT01385995|O2|Outcome|Sham CPAP|
251874|NCT01386528|O1|Outcome|Nonacog Beta Pegol|New patients as well as transferred patients from the pivotal trial (NN7999-3747) or the extension trial(NN7999-3775) received nonacog beta pegol at screening and followed a preventive treatment regimen with nonacog beta pegol until one week before the day of surgery. No more than 4 hours prior to the planned surgical procedure, all patients received a single bolus injection of 80 U/kg of nonacog beta pegol. Postoperatively, the patients received fixed doses of 40 U/kg repeated at the investigator’s discretion aiming for no less than the FIX levels recommended by the World Federation of Hemophilia. Nonacog beta pegol was administered intravenously. The new patients were dosed once with 40 U/kg nonacog beta pegol at screening.From the day after surgery (Day 1) and through Day 6, nonacog beta pegol dosing was adjusted to aim for a FIX activity level of approximately 0.50 U/mL.
251875|NCT01386528|O1|Outcome|Nonacog Beta Pegol|New patients as well as transferred patients from the pivotal trial (NN7999-3747) or the extension trial(NN7999-3775) received nonacog beta pegol at screening and followed a preventive treatment regimen with nonacog beta pegol until one week before the day of surgery. No more than 4 hours prior to the planned surgical procedure, all patients received a single bolus injection of 80 U/kg of nonacog beta pegol. Postoperatively, the patients received fixed doses of 40 U/kg repeated at the investigator’s discretion aiming for no less than the FIX levels recommended by the World Federation of Hemophilia. Nonacog beta pegol was administered intravenously. The new patients were dosed once with 40 U/kg nonacog beta pegol at screening.From the day after surgery (Day 1) and through Day 6, nonacog beta pegol dosing was adjusted to aim for a FIX activity level of approximately 0.50 U/mL.
251876|NCT01386528|O1|Outcome|Nonacog Beta Pegol|New patients as well as transferred patients from the pivotal trial (NN7999-3747) or the extension trial(NN7999-3775) received nonacog beta pegol at screening and followed a preventive treatment regimen with nonacog beta pegol until one week before the day of surgery. No more than 4 hours prior to the planned surgical procedure, all patients received a single bolus injection of 80 U/kg of nonacog beta pegol. Postoperatively, the patients received fixed doses of 40 U/kg repeated at the investigator’s discretion aiming for no less than the FIX levels recommended by the World Federation of Hemophilia. Nonacog beta pegol was administered intravenously. The new patients were dosed once with 40 U/kg nonacog beta pegol at screening.From the day after surgery (Day 1) and through Day 6, nonacog beta pegol dosing was adjusted to aim for a FIX activity level of approximately 0.50 U/mL.
251877|NCT01386528|O1|Outcome|Nonacog Beta Pegol|New patients as well as transferred patients from the pivotal trial (NN7999-3747) or the extension trial(NN7999-3775) received nonacog beta pegol at screening and followed a preventive treatment regimen with nonacog beta pegol until one week before the day of surgery. No more than 4 hours prior to the planned surgical procedure, all patients received a single bolus injection of 80 U/kg of nonacog beta pegol. Postoperatively, the patients received fixed doses of 40 U/kg repeated at the investigator’s discretion aiming for no less than the FIX levels recommended by the World Federation of Hemophilia. Nonacog beta pegol was administered intravenously. The new patients were dosed once with 40 U/kg nonacog beta pegol at screening.From the day after surgery (Day 1) and through Day 6, nonacog beta pegol dosing was adjusted to aim for a FIX activity level of approximately 0.50 U/mL.
251878|NCT01386528|E1|Reported Event|Nonacog Beta Pegol|New patients as well as transferred patients from the pivotal trial (NN7999-3747) or the extension trial(NN7999-3775) received nonacog beta pegol at screening and followed a preventive treatment regimen with nonacog beta pegol until one week before the day of surgery. No more than 4 hours prior to the planned surgical procedure, all patients received a single bolus injection of 80 U/kg of nonacog beta pegol. Postoperatively, the patients received fixed doses of 40 U/kg repeated at the investigator’s discretion aiming for no less than the FIX levels recommended by the World Federation of Hemophilia. Nonacog beta pegol was administered intravenously. The new patients were dosed once with 40 U/kg nonacog beta pegol at screening.From the day after surgery (Day 1) and through Day 6, nonacog beta pegol dosing was adjusted to aim for a FIX activity level of approximately 0.50 U/mL.
251879|NCT01386125|B3|Baseline|Total|Total of all reporting groups
251880|NCT01386125|B2|Baseline|Placebo|Participants receive matching placebo nasal spray BID for 16 weeks
251881|NCT01386125|B1|Baseline|MFNS|Participants receive MFNS 200 mcg BID for 16 weeks
251882|NCT01386125|P2|Participant Flow|Placebo|Participants receive matching placebo nasal spray BID for 16 weeks
251883|NCT01386125|P1|Participant Flow|Mometasone Furoate Nasal Spray (MFNS)|Participants receive mometasone furoate nasal spray (MFNS) 200 mcg twice daily (BID) for 16 weeks
251884|NCT01386125|O2|Outcome|Placebo|Participants receive matching placebo nasal spray BID for 16 weeks
251885|NCT01386125|O1|Outcome|MFNS|Participants receive MFNS 200 mcg BID for 16 weeks
251886|NCT01386125|O2|Outcome|Placebo|Participants receive matching placebo nasal spray BID for 16 weeks
251887|NCT01386125|O1|Outcome|MFNS|Participants receive MFNS 200 mcg BID for 16 weeks
251888|NCT01386125|E2|Reported Event|Placebo|Participants receive matching placebo nasal spray BID for 16 weeks
251889|NCT01386125|E1|Reported Event|MFNS|Participants receive MFNS 200 mcg BID for 16 weeks
251890|NCT01386008|B1|Baseline|Overall Study Group|investigational enfilcon A contact lenses worn daily wear and senofilcon A contact lens worn daily wear
251891|NCT01386008|P1|Participant Flow|Overall Study Group|investigational enfilcon A contact lenses worn daily wear and senofilcon A contact lens worn daily wear
251892|NCT01386008|O1|Outcome|Enfilcon A + Senofilcon A|Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
251893|NCT01386008|O1|Outcome|Enfilcon A + Senofilcon A|Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
251894|NCT01386008|O1|Outcome|Enfilcon A + Senofilcon A|Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
251895|NCT01386008|O1|Outcome|Enfilcon A + Senofilcon A|Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
251896|NCT01386008|E1|Reported Event|Overall Study Group|investigational enfilcon A contact lenses worn daily wear and senofilcon A contact lens worn daily wear
251897|NCT01385995|B3|Baseline|Total|Total of all reporting groups
251898|NCT01385995|B2|Baseline|Sham-Continuous Positive Airway Pressure|
251899|NCT01385995|B1|Baseline|Continuous Positive Airway Pressure (CPAP)|
251910|NCT01385995|O2|Outcome|Sham CPAP|Assessment of number of subjects with normalization of oral glucose tolerance test from baseline after sham CPAP therapy, in total sample, with the sham periods of both sequences combined.
251911|NCT01385995|O1|Outcome|Therapeutic CPAP|Assessment of number of subjects with normalization of oral glucose tolerance test from baseline after therapeutic CPAP therapy, in total sample, with the active periods of both sequences combined.
251912|NCT01385995|E2|Reported Event|Sham-Continuous Positive Airway Pressure|
251913|NCT01385995|E1|Reported Event|Continuous Positive Airway Pressure (CPAP)|
251914|NCT01385748|B4|Baseline|Total|Total of all reporting groups
251915|NCT01385748|B3|Baseline|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets, once a day every day up to 8 weeks
251916|NCT01385748|B2|Baseline|Clonidine Lauriad® 100 µg|Clonidine Lauriad® 100 µg: 100µg muco-adhesive buccal tablets once a day every day up to 8 weeks
251917|NCT01385748|B1|Baseline|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50µg muco-adhesive buccal tablet once a day every day up to 8 weeks
251918|NCT01385748|P3|Participant Flow|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
251919|NCT01385748|P2|Participant Flow|Clonidine Lauriad® 100 µg|Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
251920|NCT01385748|P1|Participant Flow|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
251921|NCT01385748|O4|Outcome|Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled|Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
251922|NCT01385748|O3|Outcome|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
251923|NCT01385748|O2|Outcome|Clonidine Lauriad® 100 µg|Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
251924|NCT01385748|O1|Outcome|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
251925|NCT01385748|O4|Outcome|Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled|Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
251926|NCT01385748|O3|Outcome|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
251927|NCT01385748|O2|Outcome|Clonidine Lauriad® 100µg|Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
251928|NCT01385748|O1|Outcome|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
251929|NCT01385748|O4|Outcome|Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled|Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
251930|NCT01385748|O3|Outcome|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
251931|NCT01385748|O2|Outcome|Clonidine Lauriad® 100 µg|Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
251932|NCT01385748|O1|Outcome|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
251933|NCT01385748|O4|Outcome|Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled|Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
251934|NCT01385748|O3|Outcome|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
251935|NCT01385748|O2|Outcome|Clonidine Lauriad® 100 µg|Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
251936|NCT01385748|O1|Outcome|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50µg muco-adhesive buccal tablet once a day every day up to 8 weeks
251937|NCT01385748|O4|Outcome|Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled|Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
251938|NCT01385748|O3|Outcome|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
251939|NCT01385748|O2|Outcome|Clonidine Lauriad® 100 µg|Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
251940|NCT01385748|O1|Outcome|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
251941|NCT01385748|O4|Outcome|Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled|Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
251942|NCT01385748|O3|Outcome|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
251943|NCT01385748|O2|Outcome|Clonidine Lauriad® 100 µg|Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
251944|NCT01385748|O1|Outcome|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
251945|NCT01385748|O4|Outcome|Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled|Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
251946|NCT01385748|O3|Outcome|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
251947|NCT01385748|O2|Outcome|Clonidine Lauriad® 100 µg|Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
251948|NCT01385748|O1|Outcome|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
251949|NCT01385748|O4|Outcome|Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled|Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
251950|NCT01385748|O3|Outcome|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
251951|NCT01385748|O2|Outcome|Clonidine Lauriad® 100 µg|Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
251952|NCT01385748|O1|Outcome|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
251953|NCT01385748|O3|Outcome|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
251954|NCT01385748|O2|Outcome|Clonidine Lauriad® 100 µg|Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
251955|NCT01385748|O1|Outcome|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50µg muco-adhesive buccal tablet once a day every day up to 8 weeks
251956|NCT01385748|O4|Outcome|Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled|Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
251957|NCT01385748|O3|Outcome|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
251958|NCT01385748|O2|Outcome|Clonidine Lauriad® 100 µg|Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
251959|NCT01385748|O1|Outcome|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
251960|NCT01385748|E4|Reported Event|Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled|Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks
251961|NCT01385748|E3|Reported Event|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets, once a day every day up to 8 weeks
251962|NCT01385748|E2|Reported Event|Clonidine Lauriad® 100µg|Clonidine Lauriad® 100µg: 100µg muco-adhesive buccal tablets once a day every day up to 8 weeks
251963|NCT01385748|E1|Reported Event|Clonidine Lauriad® 50µg|Clonidine Lauriad® 50µg: 50µg muco-adhesive buccal tablet once a day every day up to 8 weeks
251964|NCT01385696|B1|Baseline|Overall Study Safety Population|All patients randomized into the study excluding 1 patient who used Handihaler® once only, Genuair® zero times, & was excluded from the safety population
251965|NCT01385696|P2|Participant Flow|Placebo HandiHaler (Daily) Then Placebo Genuair (Daily)|Each morning, patients used the HandiHaler® (Boehringer Ingelheim) inhaler containing placebo followed by the Genuair® (Almirall S.A.) inhaler containing placebo. The study period consisted of 1 period of 14 days.
251966|NCT01385696|P1|Participant Flow|Placebo Genuair (Daily) Then Placebo HandiHaler (Daily)|Each morning, patients used the Genuair® (Almirall S.A.) inhaler containing placebo followed by the HandiHaler® (Boehringer Ingelheim) inhaler containing placebo. The study period consisted of 1 period of 14 days.
251967|NCT01385696|O2|Outcome|Handihaler Inhaler|Intention-to-treat (ITT) population
251968|NCT01385696|O1|Outcome|Genuair Inhaler|Intention-to-treat (ITT) population
251969|NCT01385696|O2|Outcome|Handihaler Inhaler|Intention-to-treat (ITT) population
251970|NCT01385696|O1|Outcome|Genuair Inhaler|Intention-to-treat (ITT) population
251971|NCT01385696|O1|Outcome|Overall Intention-to-treat Population|Overall intention-to-treat (ITT) population
251972|NCT01385696|E2|Reported Event|HandiHaler Then Genuair|The study period consisted of 1 period of 14 days. Every morning patients used the HandiHaler® (Boehringer Ingelheim)inhaler containing placebo follow by the Genuair® (Almirall S.A.) inhaler containing placebo.
251973|NCT01385696|E1|Reported Event|Genuair Then HandiHaler|The study period consisted of 1 period of 14 days. Every morning patients used the Genuair® (Almirall S.A.) inhaler containing placebo follow by the HandiHaler® (Boehringer Ingelheim) inhaler containing placebo.
251974|NCT01385644|B3|Baseline|Total|Total of all reporting groups
251975|NCT01385644|B2|Baseline|2*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
251976|NCT01385644|B1|Baseline|1*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
251977|NCT01385644|P2|Participant Flow|2*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
251978|NCT01385644|P1|Participant Flow|1*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
251979|NCT01385644|O2|Outcome|2*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
252000|NCT01385566|B5|Baseline|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
251980|NCT01385644|O1|Outcome|1*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
251981|NCT01385644|O2|Outcome|2*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
251982|NCT01385644|O1|Outcome|1*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
251983|NCT01385644|O2|Outcome|2*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
251984|NCT01385644|O1|Outcome|1*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
251985|NCT01385644|O2|Outcome|2*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
251986|NCT01385644|O1|Outcome|1*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
251987|NCT01385644|E2|Reported Event|2*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
251988|NCT01385644|E1|Reported Event|1*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
251989|NCT01385579|B3|Baseline|Total|Total of all reporting groups
251990|NCT01385579|B2|Baseline|Care Manager Outreach|Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit
251991|NCT01385579|B1|Baseline|Usual Care|Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.
251992|NCT01385579|P2|Participant Flow|Care Manager Outreach|Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit
251993|NCT01385579|P1|Participant Flow|Usual Care|Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.
251994|NCT01385579|O2|Outcome|Care Manager Outreach|Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit
251995|NCT01385579|O1|Outcome|Usual Care|Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.
251996|NCT01385579|E2|Reported Event|Care Manager Outreach|Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit
251997|NCT01385579|E1|Reported Event|Usual Care|Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.
251998|NCT01385566|B7|Baseline|Total|Total of all reporting groups
251999|NCT01385566|B6|Baseline|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252001|NCT01385566|B4|Baseline|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252002|NCT01385566|B3|Baseline|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252003|NCT01385566|B2|Baseline|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252004|NCT01385566|B1|Baseline|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
252005|NCT01385566|P6|Participant Flow|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252006|NCT01385566|P5|Participant Flow|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252007|NCT01385566|P4|Participant Flow|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252008|NCT01385566|P3|Participant Flow|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252009|NCT01385566|P2|Participant Flow|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252010|NCT01385566|P1|Participant Flow|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
252011|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252012|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252013|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252014|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252015|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252016|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
252017|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252018|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252019|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252020|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252063|NCT01385371|B1|Baseline|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
252021|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252022|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
252023|NCT01385566|O7|Outcome|Placebo|On Day 1 of the study, participants will receive a dose of ZOSTAVAX™ administered in one limb according to their randomized treatment group, and a dose of saline placebo in the alternate limb. Participants in this group were included in the analyses for the V211 treatment groups, and are replicated here specifically to report injection-site adverse experiences reported for the limb receiving a placebo injection.
252024|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252025|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252026|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252027|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252028|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252029|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
252030|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252031|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252032|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252033|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252034|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252035|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
252036|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252037|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252038|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252039|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252040|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252064|NCT01385371|P2|Participant Flow|Placebo|Participants receiving Placebo
252041|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
252042|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252043|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252044|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252045|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252046|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252047|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
252048|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252049|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252050|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252051|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252052|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252053|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
252054|NCT01385566|E7|Reported Event|Placebo|On Day 1 of the study, participants will receive a dose of ZOSTAVAX™ administered in one limb according to their randomized treatment group, and a dose of saline placebo in the alternate limb. Only injection-site adverse events occurring in the placebo limb are reported; systemic adverse events are reported by V211 treatment group only.
252055|NCT01385566|E6|Reported Event|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252056|NCT01385566|E5|Reported Event|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252057|NCT01385566|E4|Reported Event|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252058|NCT01385566|E3|Reported Event|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252059|NCT01385566|E2|Reported Event|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
252060|NCT01385566|E1|Reported Event|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
252061|NCT01385371|B3|Baseline|Total|Total of all reporting groups
252062|NCT01385371|B2|Baseline|Placebo|Participants receiving Placebo
252117|NCT01385189|O2|Outcome|10 µg Na-GST-1/Alhydrogel/GLA-AF (1 µg)|
252065|NCT01385371|P1|Participant Flow|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
252066|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
252067|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
252068|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
252069|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
252070|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
252071|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
252072|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
252073|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
252074|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
252075|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
252076|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
252077|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
252078|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
252079|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
252080|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
252081|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
252082|NCT01385371|E2|Reported Event|Placebo|Participants receiving Placebo
252083|NCT01385371|E1|Reported Event|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
252084|NCT01385293|B1|Baseline|BKM 120|BKM120 at 100mg orally daily
252085|NCT01385293|P1|Participant Flow|BKM 120|BKM120 at 100mg orally daily
252086|NCT01385293|O1|Outcome|BKM 120|BKM120 at 100mg orally daily
252087|NCT01385293|O1|Outcome|BKM 120|BKM120 at 100mg orally daily
252088|NCT01385293|O1|Outcome|BKM 120|BKM120 at 100mg orally daily
252089|NCT01385293|O1|Outcome|BKM 120|BKM120 at 100mg orally daily
252090|NCT01385293|O1|Outcome|BKM 120|BKM120 at 100mg orally daily
252091|NCT01385293|O1|Outcome|BKM 120|BKM120 at 100mg orally daily
252092|NCT01385293|O1|Outcome|BKM 120|BKM120 at 100mg orally daily
252093|NCT01385293|E1|Reported Event|BKM 120|BKM120 at 100mg orally daily
252094|NCT01385202|B1|Baseline|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
252095|NCT01385202|P1|Participant Flow|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
252096|NCT01385202|O2|Outcome|Calibration Roll-in|Calibration roll-in case(s) is intended to calibrate an investigator’s tactile feel, catheter manipulation technique, and use of other surrogate measures (electrogram signal, impedance, etc.) during the procedure.
252097|NCT01385202|O1|Outcome|THERMOCOOL® SMARTTOUCH™ Catheter-Effective Cohort|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter.
252098|NCT01385202|O1|Outcome|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
252099|NCT01385202|O1|Outcome|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
252100|NCT01385202|E1|Reported Event|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
252101|NCT01385189|B6|Baseline|Total|Total of all reporting groups
252102|NCT01385189|B5|Baseline|Cohort 5|"100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)~100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
252103|NCT01385189|B4|Baseline|Cohort 4|"100 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~100 μg Na-GST-1/Alhydrogel: 3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals"
252104|NCT01385189|B3|Baseline|Cohort 3|"30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)~30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
252105|NCT01385189|B2|Baseline|Cohort 2|"30 μg Na-GST-1/Alhydrogel vs. 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~30 μg Na-GST-1/Alhydrogel: 3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals~30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
252106|NCT01385189|B1|Baseline|Cohort 1|"10 μg Na-GST-1/Alhydrogel vs. 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~10 μg Na-GST-1/Alhydrogel: 3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals~10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
252107|NCT01385189|P5|Participant Flow|Cohort 5|"100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)~100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
252108|NCT01385189|P4|Participant Flow|Cohort 4|"100 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~100 μg Na-GST-1/Alhydrogel: 3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals"
252109|NCT01385189|P3|Participant Flow|Cohort 3|"30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)~30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
252110|NCT01385189|P2|Participant Flow|Cohort 2|"30 μg Na-GST-1/Alhydrogel vs. 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~30 μg Na-GST-1/Alhydrogel: 3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals~30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
252111|NCT01385189|P1|Participant Flow|Cohort 1|"10 μg Na-GST-1/Alhydrogel vs. 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~10 μg Na-GST-1/Alhydrogel: 3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals~10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
252112|NCT01385189|O7|Outcome|100 µg Na-GST-1/Alhydrogel/GLA-AF (5 µg)|
252113|NCT01385189|O6|Outcome|100 µg Na-GST-1/Alhydrogel|
252114|NCT01385189|O5|Outcome|30 µg Na-GST-1/Alhydrogel/GLA-AF (5 µg)|
252115|NCT01385189|O4|Outcome|30 µg Na-GST-1/Alhydrogel/GLA-AF (1 µg)|
252116|NCT01385189|O3|Outcome|30 µg Na-GST-1/Alhydrogel|
252119|NCT01385189|O5|Outcome|Cohort 5|"100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)~100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
252120|NCT01385189|O4|Outcome|Cohort 4|"100 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~100 μg Na-GST-1/Alhydrogel: 3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals"
252121|NCT01385189|O3|Outcome|Cohort 3|"30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)~30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
252122|NCT01385189|O2|Outcome|Cohort 2|"30 μg Na-GST-1/Alhydrogel vs. 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~30 μg Na-GST-1/Alhydrogel: 3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals~30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
252123|NCT01385189|O1|Outcome|Cohort 1|"10 μg Na-GST-1/Alhydrogel vs. 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~10 μg Na-GST-1/Alhydrogel: 3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals~10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
252124|NCT01385189|E5|Reported Event|Cohort 5|"100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)~100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
252125|NCT01385189|E4|Reported Event|Cohort 4|"100 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~100 μg Na-GST-1/Alhydrogel: 3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals"
252126|NCT01385189|E3|Reported Event|Cohort 3|"30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)~30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
252127|NCT01385189|E2|Reported Event|Cohort 2|"30 μg Na-GST-1/Alhydrogel vs. 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~30 μg Na-GST-1/Alhydrogel: 3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals~30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
252128|NCT01385189|E1|Reported Event|Cohort 1|"10 μg Na-GST-1/Alhydrogel vs. 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~10 μg Na-GST-1/Alhydrogel: 3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals~10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
252129|NCT01385137|B3|Baseline|Total|Total of all reporting groups
252130|NCT01385137|B2|Baseline|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
252131|NCT01385137|B1|Baseline|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
252132|NCT01385137|P2|Participant Flow|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
252133|NCT01385137|P1|Participant Flow|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
252134|NCT01385137|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
252135|NCT01385137|O1|Outcome|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
252136|NCT01385137|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
252137|NCT01385137|O1|Outcome|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
252138|NCT01385137|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
252139|NCT01385137|O1|Outcome|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
252140|NCT01385137|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
252141|NCT01385137|O1|Outcome|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
252142|NCT01385137|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
252143|NCT01385137|O1|Outcome|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
252144|NCT01385137|E2|Reported Event|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
252145|NCT01385137|E1|Reported Event|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
252146|NCT01385098|B1|Baseline|Vitamin D3 and Calcium|"Dietary supplement of vitamin D3 and calcium~Vitamin D3 and Calcium: 1500 mg of calcium citrate plus 1000 IU of vitamin D3 and 1000 IU of vitamin D3 bariatric supplements per day"
252147|NCT01385098|P1|Participant Flow|Vitamin D3 and Calcium|"Dietary supplement of vitamin D3 and calcium~Vitamin D3 and Calcium: 1500 mg of calcium citrate plus 1000 IU of vitamin D3 and 1000 IU of vitamin D3 bariatric supplements per day"
252148|NCT01385098|O2|Outcome|Roux-Y Gastric Bypass|"Dietary supplement of vitamin D3 and calcium~Vitamin D3 and Calcium: 1500 mg of calcium citrate plus 1000 IU of vitamin D3 and 1000 IU of vitamin D3 bariatric supplements per day"
252149|NCT01385098|O1|Outcome|Sleeve Gastrectomy|"Dietary supplement of vitamin D3 and calcium~Vitamin D3 and Calcium: 1500 mg of calcium citrate plus 1000 IU of vitamin D3 and 1000 IU of vitamin D3 bariatric supplements per day"
252150|NCT01385098|O1|Outcome|Vitamin D3 and Calcium|"Dietary supplement of vitamin D3 and calcium~Vitamin D3 and Calcium: 1500 mg of calcium citrate plus 1000 IU of vitamin D3 and 1000 IU of vitamin D3 bariatric supplements per day"
252338|NCT01384019|P1|Participant Flow|DP-TA|distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)
252151|NCT01385098|E1|Reported Event|Vitamin D3 and Calcium|"Dietary supplement of vitamin D3 and calcium~Vitamin D3 and Calcium: 1500 mg of calcium citrate plus 1000 IU of vitamin D3 and 1000 IU of vitamin D3 bariatric supplements per day"
252152|NCT01385033|B3|Baseline|Total|Total of all reporting groups
252153|NCT01385033|B2|Baseline|HE Participants|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
252154|NCT01385033|B1|Baseline|AD Participants|AD participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
252155|NCT01385033|P6|Participant Flow|Amnestic Mild Cognitive Impairment Participants (Part III)|Participants with amnestic Mild Cognitive Impairment received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part III)
252156|NCT01385033|P5|Participant Flow|Healthy Young (HY) Participants (Part II)|HY participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
252157|NCT01385033|P4|Participant Flow|HE Participants (Part II)|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
252158|NCT01385033|P3|Participant Flow|AD Participants (Part II)|AD participants received a single intravenous (IV) dose of ~150 megabecquerel (MBq) [18F]MK-3328, followed by PET imaging of the brain (Part II)
252159|NCT01385033|P2|Participant Flow|Healthy Elderly (HE) Participants (Part I)|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part I)
252160|NCT01385033|P1|Participant Flow|Alzheimer's Disease (AD) Participants (Part I)|AD participants received a single intravenous (IV) dose of ~150 megabecquerel (MBq) [18F]MK-3328, followed by positron emission tomography (PET) imaging of the brain (Part I)
252161|NCT01385033|O1|Outcome|HE Participants|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
252162|NCT01385033|O2|Outcome|HE Participants|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
252163|NCT01385033|O1|Outcome|AD Participants|AD participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
252164|NCT01385033|O1|Outcome|AD and HE Participants|AD and HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
252165|NCT01385033|E1|Reported Event|All Study Participants|Participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
252166|NCT01384760|B3|Baseline|Total|Total of all reporting groups
252167|NCT01384760|B2|Baseline|Simple Lifestyle Advice|Simple lifestyle advice: Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.
252168|NCT01384760|B1|Baseline|Lifestyle Modification Program|Lifestyle modification: During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
252169|NCT01384760|P2|Participant Flow|Simple Lifestyle Advice|Simple lifestyle advice: Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.
252170|NCT01384760|P1|Participant Flow|Lifestyle Modification Program|Lifestyle modification: During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
252171|NCT01384760|O2|Outcome|Simple Lifestyle Advice|Simple lifestyle advice: Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.
252172|NCT01384760|O1|Outcome|Lifestyle Modification Program|Lifestyle modification: During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
252173|NCT01384760|O2|Outcome|Simple Lifestyle Advice|Simple lifestyle advice: Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.
252193|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252339|NCT01384019|O2|Outcome|c-PCI|conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
269057|NCT01333397|O2|Outcome|Dysport NG 20 U|
252174|NCT01384760|O1|Outcome|Lifestyle Modification Program|Lifestyle modification: During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
252175|NCT01384760|E2|Reported Event|Simple Lifestyle Advice|Simple lifestyle advice: Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.
252176|NCT01384760|E1|Reported Event|Lifestyle Modification Program|Lifestyle modification: During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
252177|NCT01384591|B4|Baseline|Total|Total of all reporting groups
252178|NCT01384591|B3|Baseline|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252179|NCT01384591|B2|Baseline|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252180|NCT01384591|B1|Baseline|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252181|NCT01384591|P3|Participant Flow|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252182|NCT01384591|P2|Participant Flow|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252183|NCT01384591|P1|Participant Flow|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252184|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252185|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252186|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252187|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252188|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252189|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252190|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252191|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252192|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252337|NCT01384019|P2|Participant Flow|c-PCI|conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
252194|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252195|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252196|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252197|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252198|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252199|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252200|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252201|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252202|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252203|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252204|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252205|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252206|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252207|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252208|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252209|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252210|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252211|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252212|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252213|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252214|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
269058|NCT01333397|O1|Outcome|Placebo|
252215|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252216|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252217|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252218|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252219|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252220|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252221|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252222|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252223|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252224|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252225|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252226|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252227|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252228|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252229|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252230|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252231|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252232|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252233|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252234|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252235|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252236|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252237|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252238|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252239|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252240|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252241|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252242|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252243|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252244|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252245|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252246|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252247|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252248|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252249|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252250|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252251|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252252|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252253|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252254|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252255|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252256|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252257|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252258|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252259|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252260|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252261|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252262|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252263|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252264|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252265|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252266|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252267|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252268|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252269|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252270|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252271|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252272|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252273|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252274|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252275|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252276|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252277|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252278|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252279|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252280|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252281|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252282|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252283|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252284|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252285|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252286|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252287|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252288|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252289|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252290|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252291|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252292|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252293|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252294|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252295|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252296|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252297|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252298|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252299|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252300|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252301|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252302|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252303|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252304|NCT01384591|O3|Outcome|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252305|NCT01384591|O2|Outcome|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252306|NCT01384591|O1|Outcome|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252307|NCT01384591|E3|Reported Event|Losartan and Placebo N-acetylcysteine|"losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252308|NCT01384591|E2|Reported Event|N-acetylcysteine and Placebo Losartan|"N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2."
252309|NCT01384591|E1|Reported Event|Placebo Losartan and Placebo N-acetylcysteine|"Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.~Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2."
252310|NCT01384539|B3|Baseline|Total|Total of all reporting groups
252311|NCT01384539|B2|Baseline|Calcitriol|"Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months~Calcitriol"
252312|NCT01384539|B1|Baseline|Cholecalciferol|"Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months~Cholecalciferol"
252313|NCT01384539|P2|Participant Flow|Calcitriol|"Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months~Calcitriol"
252314|NCT01384539|P1|Participant Flow|Cholecalciferol|"Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months~Cholecalciferol"
252315|NCT01384539|O2|Outcome|Calcitriol|"Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months~Calcitriol"
252316|NCT01384539|O1|Outcome|Cholecalciferol|"Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months~Cholecalciferol"
252317|NCT01384539|E2|Reported Event|Calcitriol|"Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months~Calcitriol"
252318|NCT01384539|E1|Reported Event|Cholecalciferol|"Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months~Cholecalciferol"
252319|NCT01384292|B4|Baseline|Total|Total of all reporting groups
252320|NCT01384292|B3|Baseline|Placebo|Placebo, oral treatment
252321|NCT01384292|B2|Baseline|NKTR-118 25 mg|NKTR-118 25 mg, oral treatment
252322|NCT01384292|B1|Baseline|NKTR-118 12.5 mg|NKTR-118 12.5 mg, oral treatment
252323|NCT01384292|P3|Participant Flow|Placebo|Placebo, oral treatment
252324|NCT01384292|P2|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg, oral treatment
252325|NCT01384292|P1|Participant Flow|NKTR-118 12.5 mg|NKTR-118 12.5 mg, oral treatment
252326|NCT01384292|O3|Outcome|Placebo|Placebo, oral treatment
252327|NCT01384292|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg, oral treatment
252328|NCT01384292|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 mg, oral treatment
252329|NCT01384292|E5|Reported Event|NKTR-118 25 mg - Part B|Part B NKTR-118 25 mg, oral treatment
252330|NCT01384292|E4|Reported Event|NKTR-118 12.5 mg - Part B|Part B NKTR-118 12.5 mg, oral treatment
252331|NCT01384292|E3|Reported Event|Placebo - Part A|Part A Placebo, oral treatment
252332|NCT01384292|E2|Reported Event|NKTR-118 25 mg - Part A|Part A NKTR-118 25 mg, oral treatment
252333|NCT01384292|E1|Reported Event|NKTR-118 12.5 mg - Part A|Part A NKTR-118 12.5 mg, oral treatment
252334|NCT01384019|B3|Baseline|Total|Total of all reporting groups
252335|NCT01384019|B2|Baseline|c-PCI|conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
252336|NCT01384019|B1|Baseline|DP-TA|distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)
269059|NCT01333397|O5|Outcome|Dysport 50 U|
252340|NCT01384019|O1|Outcome|DP-TA|distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)
252341|NCT01384019|E2|Reported Event|c-PCI|conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
252342|NCT01384019|E1|Reported Event|DP-TA|distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)
252343|NCT01383993|B4|Baseline|Total|Total of all reporting groups
252344|NCT01383993|B3|Baseline|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252345|NCT01383993|B2|Baseline|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252346|NCT01383993|B1|Baseline|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252347|NCT01383993|P3|Participant Flow|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252348|NCT01383993|P2|Participant Flow|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252349|NCT01383993|P1|Participant Flow|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252350|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252351|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252352|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252353|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252354|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252355|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252356|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252357|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252358|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252359|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252360|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252361|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252362|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252363|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252364|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252365|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252366|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252367|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252368|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
254116|NCT01379183|O1|Outcome|Erythromycin|"Erythromycin 200 mg i.v. suspension~Erythromycin: 200 mg suspension"
252369|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252370|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252371|NCT01383993|O1|Outcome|All Participants|Immunocompromised children aged 2 to <15 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg or 6 mg/kg on Day 1 and 8 mg/kg or 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg or 200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252372|NCT01383993|O1|Outcome|All Participants|Immunocompromised children aged 2 to <15 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg or 6 mg/kg on Day 1 and 8 mg/kg or 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg or 200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252373|NCT01383993|O1|Outcome|All Participants|Immunocompromised children aged 2 to <15 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg or 6 mg/kg on Day 1 and 8 mg/kg or 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg or 200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252374|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252375|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252376|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252377|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252378|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252379|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252380|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252381|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252396|NCT01383954|P1|Participant Flow|Diclofenac Gel|Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
252382|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252383|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252384|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252385|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252386|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252387|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252388|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252389|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252390|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252391|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252392|NCT01383993|E3|Reported Event|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252393|NCT01383993|E2|Reported Event|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252394|NCT01383993|E1|Reported Event|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
252395|NCT01383954|B1|Baseline|Diclofenac Gel|Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
252397|NCT01383954|O1|Outcome|Diclofenac Gel|Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
252398|NCT01383954|O1|Outcome|Diclofenac Gel|Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
252399|NCT01383954|E1|Reported Event|Diclofenac Gel|Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
252400|NCT01383928|B4|Baseline|Total|Total of all reporting groups
252401|NCT01383928|B3|Baseline|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252402|NCT01383928|B2|Baseline|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252403|NCT01383928|B1|Baseline|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252404|NCT01383928|P3|Participant Flow|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252405|NCT01383928|P2|Participant Flow|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252406|NCT01383928|P1|Participant Flow|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252407|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252408|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252518|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252519|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252738|NCT01383161|E1|Reported Event|Curcumin|"Theracurmin (180mg/day)~Curcumin: Six capsules (containing 30 mg of curcumin each) per day for 18 months."
252409|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252410|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252411|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252412|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252413|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252414|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252415|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252416|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252520|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252521|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252522|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252417|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252418|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252419|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252420|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252421|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252422|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252423|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252424|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252425|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252523|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252524|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252426|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252427|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252428|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252429|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252430|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252431|NCT01383928|O1|Outcome|Phase 1: All Participants|Ixazomib 3 mg or 3.7 mg capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving the same dose of ixazomib (MLN9708) capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252432|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252433|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252434|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252525|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252526|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252739|NCT01383096|B4|Baseline|Total|Total of all reporting groups
254117|NCT01379183|O2|Outcome|Placebo|Matching placebo i.v. suspension
252435|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252436|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252437|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252438|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252439|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252440|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252441|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252442|NCT01383928|O1|Outcome|Phase 1: All Participants|Ixazomib 3 mg or 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252443|NCT01383928|O1|Outcome|Phase 1: All Participants|Ixazomib 3 mg or 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252527|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252528|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
254118|NCT01379183|O1|Outcome|Erythromycin|Erythromycin 200 mg i.v. suspension
252444|NCT01383928|E3|Reported Event|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252445|NCT01383928|E2|Reported Event|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252446|NCT01383928|E1|Reported Event|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
252447|NCT01383720|B1|Baseline|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
252448|NCT01383720|P1|Participant Flow|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
252449|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
252450|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
252451|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
252452|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
252453|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
252454|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
252455|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
252456|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
252457|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
252458|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
252459|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
252460|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
252461|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
252462|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
252463|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
252464|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
252465|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
252466|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
252467|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
252468|NCT01383720|E1|Reported Event|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
252469|NCT01383707|B1|Baseline|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
252529|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252470|NCT01383707|P1|Participant Flow|Bevacizumab + Modified FOLFOX-6 (mFOLFOX-6)|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
252471|NCT01383707|O1|Outcome|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
252472|NCT01383707|O1|Outcome|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
252473|NCT01383707|O1|Outcome|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
252474|NCT01383707|O1|Outcome|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
252475|NCT01383707|O1|Outcome|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
252476|NCT01383707|O1|Outcome|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
252530|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252531|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
254119|NCT01379183|E2|Reported Event|Placebo|Matching placebo i.v. suspension
252477|NCT01383707|E1|Reported Event|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
252478|NCT01383681|B1|Baseline|All Participants|This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
252479|NCT01383681|P1|Participant Flow|All Participants|This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
252480|NCT01383681|O1|Outcome|All Participants|This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
252481|NCT01383681|O1|Outcome|All Participants|This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
252482|NCT01383681|E1|Reported Event|All Participants|This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
252483|NCT01383616|B3|Baseline|Total|Total of all reporting groups
252484|NCT01383616|B2|Baseline|Bipedicular Kyphoplasty Group|In this arm two pedicles were entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.
252485|NCT01383616|B1|Baseline|Unipedicular Kyphoplasty|In this arm only vertebral body pedicle was entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.
252486|NCT01383616|P2|Participant Flow|Bipedicular Kyphoplasty Group|Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
252487|NCT01383616|P1|Participant Flow|Unipedicular Kyphoplasty|Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
252488|NCT01383616|O2|Outcome|Bipedicular Kyphoplasty Group|Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
252532|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252533|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
269060|NCT01333397|O4|Outcome|Dysport NG 75 U|
252489|NCT01383616|O1|Outcome|Unipedicular Kyphoplasty|Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
252490|NCT01383616|O2|Outcome|Bipedicular Kyphoplasty Group|"Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement.~A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden."
252491|NCT01383616|O1|Outcome|Unipedicular Kyphoplasty|"Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement.~A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden."
252492|NCT01383616|O2|Outcome|Bipedicular Kyphoplasty Group|"Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement.~A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden."
252493|NCT01383616|O1|Outcome|Unipedicular Kyphoplasty|"Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement.~A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden."
252494|NCT01383616|O2|Outcome|Bipedicular Kyphoplasty Group|"Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement.~A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden."
252495|NCT01383616|O1|Outcome|Unipedicular Kyphoplasty|"Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement.~A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden."
252496|NCT01383616|O2|Outcome|Bipedicular Kyphoplasty Group|"Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement.~A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden."
254120|NCT01379183|E1|Reported Event|Erythromycin|Erythromycin 200 mg i.v. suspension
252497|NCT01383616|O1|Outcome|Unipedicular Kyphoplasty|"Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement.~A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden."
252498|NCT01383616|O2|Outcome|Bipedicular Kyphoplasty Group|"Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement.~A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden."
252499|NCT01383616|O1|Outcome|Unipedicular Kyphoplasty|"Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement.~A guidewire was placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden."
252500|NCT01383616|O2|Outcome|Bipedicular Kyphoplasty Group|Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
252501|NCT01383616|O1|Outcome|Unipedicular Kyphoplasty|Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
252502|NCT01383616|O2|Outcome|Bipedicular Kyphoplasty Group|Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
252503|NCT01383616|O1|Outcome|Unipedicular Kyphoplasty|Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
252534|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252535|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252536|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252929|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
252504|NCT01383616|O1|Outcome|Bipedicular Kyphoplasty Group|"Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered deliver bone cement.~A guidewire was placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden."
252505|NCT01383616|O2|Outcome|Bipedicular Kyphoplasty Group|Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
252506|NCT01383616|O1|Outcome|Unipedicular Kyphoplasty|Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
252507|NCT01383616|E2|Reported Event|Bipedicular Kyphoplasty Group|Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.
252508|NCT01383616|E1|Reported Event|Unipedicular Kyphoplasty|Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.
252509|NCT01383499|B1|Baseline|Total.|Total number of patients randomised and treated at all in the study.
252510|NCT01383499|P4|Participant Flow|Tio R2.5/Tio R1.25/Placebo|Patients treated with Tiotropium 2.5 mcg in Period 1, with Tiotropium 1.25 mcg in Period 2 and with Placebo in Period 3. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off treatment periods) between treatments.
252511|NCT01383499|P3|Participant Flow|Placebo/Tio R2.5/Tio R5|Patients treated with Placebo in Period 1, with Tiotropium 2.5 mcg in Period 2 and with Tiotropium 5 mcg in Period 3. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off treatment periods) between treatments.
252512|NCT01383499|P2|Participant Flow|Tio R1.25/Tio R5/Tio R2.5|Patients treated with Tiotropium 1.25 mcg in Period 1, with Tiotropium 5 mcg in Period 2 and with Tiotropium 2.5 mcg in Period 3. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off treatment periods) between treatments.
252513|NCT01383499|P1|Participant Flow|Tio R5/Placebo/Tio R1.25|Patients treated with Tiotropium 5 mcg in Period 1, with Placebo in Period 2 and with Tiotropium 1.25 mcg in Period 3. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off treatment periods) between treatments.
252514|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252515|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252516|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252517|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252645|NCT01383356|O1|Outcome|Lina/Met 2.5mg/500mg|Combination tablet
252537|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252538|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252539|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252540|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252541|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252542|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252543|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252544|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252545|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252546|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252547|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252548|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252549|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252550|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252551|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252552|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252553|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252554|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252555|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252556|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252557|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252558|NCT01383499|E4|Reported Event|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252559|NCT01383499|E3|Reported Event|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252560|NCT01383499|E2|Reported Event|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252561|NCT01383499|E1|Reported Event|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
252562|NCT01383486|B1|Baseline|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and 20 Aleve 24 Hour extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
252563|NCT01383486|P1|Participant Flow|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and 20 Aleve 24 Hour extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
252564|NCT01383486|O1|Outcome|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil IR caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
252565|NCT01383486|O1|Outcome|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil IR caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
252646|NCT01383356|O2|Outcome|Lina 2.5mg Plus Met 500mg|Single tablets
252566|NCT01383486|O1|Outcome|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
252567|NCT01383486|E1|Reported Event|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil IR caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
252568|NCT01383447|B1|Baseline|Treatment (Entinostat and Imatinib Mesylate)|"Patients receive entinostat PO daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~entinostat: Given PO~imatinib mesylate: Given PO~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~western blotting: Correlative studies~immunohistochemistry staining method: Correlative studies~flow cytometry: Correlative studies~polymerase chain reaction: Correlative studies~high performance liquid chromatography: Correlative studies~mass spectrometry: Correlative studies"
252569|NCT01383447|P1|Participant Flow|Treatment (Entinostat and Imatinib Mesylate)|"Patients receive entinostat PO daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~entinostat: Given PO~imatinib mesylate: Given PO~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~western blotting: Correlative studies~immunohistochemistry staining method: Correlative studies~flow cytometry: Correlative studies~polymerase chain reaction: Correlative studies~high performance liquid chromatography: Correlative studies~mass spectrometry: Correlative studies"
252570|NCT01383447|O1|Outcome|Treatment (Entinostat and Imatinib Mesylate)|"Patients receive entinostat PO daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~entinostat: Given PO~imatinib mesylate: Given PO~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~western blotting: Correlative studies~immunohistochemistry staining method: Correlative studies~flow cytometry: Correlative studies~polymerase chain reaction: Correlative studies~high performance liquid chromatography: Correlative studies~mass spectrometry: Correlative studies"
252571|NCT01383447|O1|Outcome|Treatment (Entinostat and Imatinib Mesylate)|"Patients receive entinostat PO daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~entinostat: Given PO~imatinib mesylate: Given PO~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~western blotting: Correlative studies~immunohistochemistry staining method: Correlative studies~flow cytometry: Correlative studies~polymerase chain reaction: Correlative studies~high performance liquid chromatography: Correlative studies~mass spectrometry: Correlative studies"
252572|NCT01383447|O1|Outcome|Treatment (Entinostat and Imatinib Mesylate)|"Patients receive entinostat PO daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~entinostat: Given PO~imatinib mesylate: Given PO~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~western blotting: Correlative studies~immunohistochemistry staining method: Correlative studies~flow cytometry: Correlative studies~polymerase chain reaction: Correlative studies~high performance liquid chromatography: Correlative studies~mass spectrometry: Correlative studies"
252573|NCT01383447|O1|Outcome|Treatment (Entinostat and Imatinib Mesylate)|"Patients receive entinostat PO daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~entinostat: Given PO~imatinib mesylate: Given PO~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~western blotting: Correlative studies~immunohistochemistry staining method: Correlative studies~flow cytometry: Correlative studies~polymerase chain reaction: Correlative studies~high performance liquid chromatography: Correlative studies~mass spectrometry: Correlative studies"
252574|NCT01383447|O1|Outcome|Treatment (Entinostat and Imatinib Mesylate)|"Patients receive entinostat PO daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~entinostat: Given PO~imatinib mesylate: Given PO~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~western blotting: Correlative studies~immunohistochemistry staining method: Correlative studies~flow cytometry: Correlative studies~polymerase chain reaction: Correlative studies~high performance liquid chromatography: Correlative studies~mass spectrometry: Correlative studies"
252575|NCT01383447|E1|Reported Event|Treatment (Entinostat and Imatinib Mesylate)|"Patients receive entinostat PO daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~entinostat: Given PO~imatinib mesylate: Given PO~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~western blotting: Correlative studies~immunohistochemistry staining method: Correlative studies~flow cytometry: Correlative studies~polymerase chain reaction: Correlative studies~high performance liquid chromatography: Correlative studies~mass spectrometry: Correlative studies"
252576|NCT01383421|B1|Baseline|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (without taking participation in the study into account), with the first dose corresponding to the Enrollment/Baseline visit.~All participants were offered to participate in the PSP while treated by ADA for their RA."
252577|NCT01383421|P1|Participant Flow|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~All participants were offered to participate in the PSP while treated by ADA for their RA."
252647|NCT01383356|O1|Outcome|Lina/Met 2.5mg/500mg|Combination tablet
252648|NCT01383356|E2|Reported Event|Lina 2.5mg Plus Met 500mg|Single tablets
252578|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252579|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252580|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252581|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252582|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants did not utilize the PSP that was offered."
252583|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252584|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants did not utilize the PSP that was offered."
252585|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252586|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants did not utilize the PSP that was offered."
252587|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252588|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants did not utilize the PSP that was offered."
252589|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252590|NCT01383421|O3|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants did not utilize the PSP that was offered."
252591|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252592|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~All participants were offered to participate in the PSP while treated with ADA for their RA."
252593|NCT01383421|O3|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants did not utilize the PSP that was offered."
252594|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252595|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~All participants were offered to participate in the PSP while treated with ADA for their RA."
252596|NCT01383421|O3|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants did not utilize the PSP that was offered."
252597|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252598|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~All participants were offered to participate in the PSP while treated with ADA for their RA."
252649|NCT01383356|E1|Reported Event|Lina/Met 2.5mg/500mg|Combination tablet
252650|NCT01383317|B3|Baseline|Total|Total of all reporting groups
252599|NCT01383421|O3|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants did not utilize the PSP that was offered."
252600|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252601|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~All participants were offered to participate in the PSP while treated with ADA for their RA."
252602|NCT01383421|O3|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants did not utilize the PSP that was offered."
252603|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252604|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~All participants were offered to participate in the PSP while treated with ADA for their RA."
252605|NCT01383421|O3|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants did not utilize the PSP that was offered."
252606|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252607|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~All participants were offered to participate in the PSP while treated with ADA for their RA."
252608|NCT01383421|O3|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants did not utilize the PSP that was offered."
252609|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252610|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~All participants were offered to participate in the PSP while treated with ADA for their RA."
252611|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants did not utilize the PSP that was offered."
252612|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252613|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants did not utilize the PSP that was offered."
252614|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252615|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants did not utilize the PSP that was offered."
252616|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252617|NCT01383421|O3|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants did not utilize the PSP that was offered."
252618|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252619|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~All participants were offered to participate in the PSP while treated with ADA for their RA."
252930|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
252620|NCT01383421|O3|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants did not utilize the PSP that was offered."
252621|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252622|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~All participants were offered to participate in the PSP while treated with ADA for their RA."
252623|NCT01383421|O3|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants did not utilize the PSP that was offered."
252624|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252625|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~All participants were offered to participate in the PSP while treated with ADA for their RA."
252626|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants did not utilize the PSP that was offered."
252627|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252628|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants did not utilize the PSP that was offered."
252629|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252630|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants did not utilize the PSP that was offered."
252631|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252632|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants did not utilize the PSP that was offered."
252633|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252634|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants did not utilize the PSP that was offered."
252635|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252636|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants did not utilize the PSP that was offered."
252637|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~These participants utilized the PSP that was offered."
252638|NCT01383421|E1|Reported Event|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.~All participants were offered to participate in the PSP while treated with ADA for their RA."
252639|NCT01383356|B1|Baseline|Entire Study Population|Total number of subjects randomised and treated in the study.
252640|NCT01383356|P2|Participant Flow|Lina 2.5mg Plus Met 500mg Then Lina/Met 2.5mg/500mg|Single tablets Linagliptin 2.5mg plus Metformin 500mg followed by combination tablet Linagliptin/Metformin 2.5mg/500mg
252641|NCT01383356|P1|Participant Flow|Lina/Met 2.5mg/500mg Then Lina 2.5mg Plus Met 500mg|Combination tablet Linagliptin (Lina) /Metformin (Met) 2.5mg/500mg followed by single tablets Linagliptin 2.5mg plus Metformin 500mg
252642|NCT01383356|O2|Outcome|Lina 2.5mg Plus Met 500mg|Single tablets
252643|NCT01383356|O1|Outcome|Lina/Met 2.5mg/500mg|Combination tablet
252644|NCT01383356|O2|Outcome|Lina 2.5mg Plus Met 500mg|Single tablets
252651|NCT01383317|B2|Baseline|Sham RIPC|"A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Sham RIPC: Disposable sterile thigh tourniquet"
252652|NCT01383317|B1|Baseline|RIPC|"A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet"
252653|NCT01383317|P2|Participant Flow|Sham RIPC|"A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Sham RIPC: Disposable sterile thigh tourniquet"
252654|NCT01383317|P1|Participant Flow|RIPC|"A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet"
252655|NCT01383317|O2|Outcome|Sham RIPC|"A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Sham RIPC: Disposable sterile thigh tourniquet"
252656|NCT01383317|O1|Outcome|RIPC|"A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet"
252657|NCT01383317|O2|Outcome|Sham RIPC|"A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Sham RIPC: Disposable sterile thigh tourniquet"
252658|NCT01383317|O1|Outcome|RIPC|"A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet"
252659|NCT01383317|O2|Outcome|Sham RIPC|"A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Sham RIPC: Disposable sterile thigh tourniquet"
252660|NCT01383317|O1|Outcome|RIPC|"A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet"
252661|NCT01383317|O2|Outcome|Sham RIPC|"A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Sham RIPC: Disposable sterile thigh tourniquet"
252662|NCT01383317|O1|Outcome|RIPC|"A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet"
252663|NCT01383317|O2|Outcome|Sham RIPC|"A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Sham RIPC: Disposable sterile thigh tourniquet"
252664|NCT01383317|O1|Outcome|RIPC|"A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet"
252665|NCT01383317|O2|Outcome|Sham RIPC|"A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Sham RIPC: Disposable sterile thigh tourniquet"
252666|NCT01383317|O1|Outcome|RIPC|"A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet"
252667|NCT01383317|O2|Outcome|Sham RIPC|"A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Sham RIPC: Disposable sterile thigh tourniquet"
252668|NCT01383317|O1|Outcome|RIPC|"A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet"
252669|NCT01383317|O2|Outcome|Sham RIPC|"A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Sham RIPC: Disposable sterile thigh tourniquet"
252670|NCT01383317|O1|Outcome|RIPC|"A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet"
252671|NCT01383317|O2|Outcome|Sham RIPC|"A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Sham RIPC: Disposable sterile thigh tourniquet"
252672|NCT01383317|O1|Outcome|RIPC|"A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet"
252673|NCT01383317|E2|Reported Event|Sham RIPC|"A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Sham RIPC: Disposable sterile thigh tourniquet"
252674|NCT01383317|E1|Reported Event|RIPC|"A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times~Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet"
252675|NCT01383213|B3|Baseline|Total|Total of all reporting groups
252676|NCT01383213|B2|Baseline|Oxygen Therapy (Group B)|group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%.
252677|NCT01383213|B1|Baseline|CPAP (Group A)|group A will be treated with CPAP using a helmet, initial PEEP of 10 cmH20 and an FiO2 set in order to maintain SpO2 ≥92%
252678|NCT01383213|P2|Participant Flow|Oxygen Therapy (Group B)|group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%.
252679|NCT01383213|P1|Participant Flow|CPAP (Group A)|group A will be treated with CPAP using a helmet, initial PEEP of 10 cmH20 and an FiO2 set in order to maintain SpO2 ≥92%
252680|NCT01383213|O2|Outcome|Oxygen Therapy (Group B)|"group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%.~Oxygen therapy: patient in group oxygen therapy by Venturi Mask will be treated with oxygen until reaching clinical stability, or criteria of endotracheal intubation"
252681|NCT01383213|O1|Outcome|CPAP (Group A)|"group A will be treated with CPAP using a helmet, initial PEEP of 10 cmH20 and an FiO2 set in order to maintain SpO2 ≥92%~Helmet CPAP: patient in group CPAP will be treated with CPAP until reaching clinical stability, or criteria of endotracheal intubation"
252682|NCT01383213|E2|Reported Event|Oxygen Therapy (Group B)|"group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%.~Oxygen therapy: patient in group oxygen therapy by Venturi Mask will be treated with oxygen until reaching clinical stability, or criteria of endotracheal intubation"
252683|NCT01383213|E1|Reported Event|CPAP (Group A)|"group A will be treated with CPAP using a helmet, initial PEEP of 10 cmH20 and an FiO2 set in order to maintain SpO2 ≥92%~Helmet CPAP: patient in group CPAP will be treated with CPAP until reaching clinical stability, or criteria of endotracheal intubation"
252684|NCT01383200|B3|Baseline|Total|Total of all reporting groups
252685|NCT01383200|B2|Baseline|TetracaineLeft Eye /LidocaineRight Eye|0.5% tetracaine drops Left eye / 2% lidocaine gel Right eye
252686|NCT01383200|B1|Baseline|TetracaineRight Eye / LidocaineLeft Eye|0.5% tetracaine drops Right eye /2% lidocaine gel Left eye
252687|NCT01383200|P2|Participant Flow|Tetracaine Left Eye / Lidocaine Right Eye|"Each eye of the Subject was randomized using random number tables to receive either topical 0.5% tetracaine drops or 20% lidocaine gel~11 eyes received 20% lidocaine gel."
252688|NCT01383200|P1|Participant Flow|Tetracaine Right Eye / Lidocaine Left Eye|"Each eye of the Subject was randomized using random number tables to receive either topical 0.5% tetracaine drops or 20% lidocaine gel~11 eyes received 0.5% tetracaine drops."
252689|NCT01383200|O2|Outcome|Lidocaine|2% lidocaine gel
252690|NCT01383200|O1|Outcome|Tetracaine|0.5% tetracaine drops
252691|NCT01383200|E2|Reported Event|Tetracaine Left Eye / Lidocaine Right Eye|0.5% Tetracaine Left eye / 2% Lidocaine Right eye
252692|NCT01383200|E1|Reported Event|Tetracaine Right Eye / Lidocaine Left Eye|0.5% Tetracaine drops Right eye / 2% Lidocaine Left eye
252693|NCT01383174|B3|Baseline|Total|Total of all reporting groups
252694|NCT01383174|B2|Baseline|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
252695|NCT01383174|B1|Baseline|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
252696|NCT01383174|P2|Participant Flow|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
252697|NCT01383174|P1|Participant Flow|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
252698|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
252699|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
252700|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
252701|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
252702|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
252703|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
252704|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
252705|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
252706|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
252736|NCT01383161|O1|Outcome|Curcumin|"Theracurmin (180mg/day)~Curcumin: Six capsules (containing 30 mg of curcumin each) per day for 18 months."
252707|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
252708|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
252709|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
252710|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
252711|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
252712|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
252713|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
252714|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
252715|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
252716|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
252717|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
252718|NCT01383174|E2|Reported Event|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
252719|NCT01383174|E1|Reported Event|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
252720|NCT01383161|B3|Baseline|Total|Total of all reporting groups
252721|NCT01383161|B2|Baseline|Placebo|"Sugar Pill~Placebo: Six capsules per day for 18 months."
252722|NCT01383161|B1|Baseline|Curcumin|"Theracurmin (180mg/day)~Curcumin: Six capsules (containing 30 mg of curcumin each) per day for 18 months."
252723|NCT01383161|P2|Participant Flow|Placebo|"Sugar Pill~Placebo: Six capsules per day for 18 months."
252724|NCT01383161|P1|Participant Flow|Curcumin|"Theracurmin (180mg/day)~Curcumin: Six capsules (containing 30 mg of curcumin each) per day for 18 months."
252725|NCT01383161|O2|Outcome|Placebo|"Sugar Pill~Placebo: Six capsules per day for 18 months."
252726|NCT01383161|O1|Outcome|Curcumin|"Theracurmin (180mg/day)~Curcumin: Six capsules (containing 30 mg of curcumin each) per day for 18 months."
252727|NCT01383161|O2|Outcome|Placebo|"Sugar Pill~Placebo: Six capsules per day for 18 months."
252728|NCT01383161|O1|Outcome|Curcumin|"Theracurmin (180mg/day)~Curcumin: Six capsules (containing 30 mg of curcumin each) per day for 18 months."
252729|NCT01383161|O2|Outcome|Placebo|"Sugar Pill~Placebo: Six capsules per day for 18 months."
252730|NCT01383161|O1|Outcome|Curcumin|"Theracurmin (180mg/day)~Curcumin: Six capsules (containing 30 mg of curcumin each) per day for 18 months."
252731|NCT01383161|O2|Outcome|Placebo|"Sugar Pill~Placebo: Six capsules per day for 18 months."
252732|NCT01383161|O1|Outcome|Curcumin|"Theracurmin (180mg/day)~Curcumin: Six capsules (containing 30 mg of curcumin each) per day for 18 months."
252733|NCT01383161|O2|Outcome|Placebo|"Sugar Pill~Placebo: Six capsules per day for 18 months."
252734|NCT01383161|O1|Outcome|Curcumin|"Theracurmin (180mg/day)~Curcumin: Six capsules (containing 30 mg of curcumin each) per day for 18 months."
252735|NCT01383161|O2|Outcome|Placebo|"Sugar Pill~Placebo: Six capsules per day for 18 months."
252737|NCT01383161|E2|Reported Event|Placebo|"Sugar Pill~Placebo: Six capsules per day for 18 months."
252740|NCT01383096|B3|Baseline|Cohort 3|Subjects received a 800mg single dose of OZ439 prototype solution formulation 1 fasted and then a 400mg single dose of OZ439 of prototype solution formulation 1 fasted.
252741|NCT01383096|B2|Baseline|Cohort 2|Subjects received a single dose of OZ439 800mg PIB Fasted, then OZ439 800mg with milk, OZ439 800mg Prototype 2 Fasted, OZ439 800mg Prototype 2 with milk.
252742|NCT01383096|B1|Baseline|Cohort 1|Subjects received a single dose of OZ439 800mg PIB Fed, then OZ439 PIB Fasted, then OZ439 800mg with milk, OZ439 800mg Prototype 1 Fasted, OZ439 800mg Prototype 1 with milk.
252743|NCT01383096|P3|Participant Flow|Cohort 3|Subjects received a 800mg single dose of OZ439 prototype solution formulation 1 fasted and then a 400mg single dose of OZ439 of prototype solution formulation 1 fasted.
252744|NCT01383096|P2|Participant Flow|Cohort 2|Subjects received a single of OZ439 800mg PIB Fasted, then OZ439 800mg with milk, OZ439 800mg Prototype 2 Fasted, OZ439 800mg Prototype 2 with milk.
252745|NCT01383096|P1|Participant Flow|Cohort 1|Subjects received a single dose of OZ439 800mg PIB Fed, then OZ439 PIB Fasted, then OZ439 800mg with milk, OZ439 800mg Prototype 1 Fasted, OZ439 800mg Prototype 1 with milk.
252746|NCT01383096|O11|Outcome|Cohort 3 - Treatment K: OZ439 400mg Prototype F1 Fasted|OZ439 400 mg as prototype solution formulation 1. Administered fasted.
252747|NCT01383096|O10|Outcome|Cohort 3 - Treatment J: OZ439 800mg Prototype F1 Fasted|OZ439 800 mg (as free base) as prototype solution formulation 1. Administered fasted.
252748|NCT01383096|O9|Outcome|Cohort 2 - Treatment I: OZ349 800mg Prototype F2 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.
252749|NCT01383096|O8|Outcome|Cohort 2 - Treatment H: OZ439 800 mg Prototype F2 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered fasted.
252750|NCT01383096|O7|Outcome|Cohort 2 - Treatment G: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
252751|NCT01383096|O6|Outcome|Cohort 2 - Treatment F: OZ439 800 mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
252752|NCT01383096|O5|Outcome|Cohort 1 - Treatment E: OZ439 800mg Prototype F1 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered with milk.
252753|NCT01383096|O4|Outcome|Cohort 1 - Treatment D: OZ439 800 mg Prototype F1 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered fasted.
252754|NCT01383096|O3|Outcome|Cohort 1 - Treatment C: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
252755|NCT01383096|O2|Outcome|Cohort 1 - Treatment B: OZ439 800mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
252756|NCT01383096|O1|Outcome|Cohort 1 - Treatment A: OZ439 800mg PIB Fed|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to administration. Administered 30 minutes after a standard fatty breakfast.
252757|NCT01383096|O11|Outcome|Cohort 3 - Treatement K: OZ439 400mg Prototype F1 Fasted|OZ439 400 mg as prototype solution formulation 1. Administered fasted.
252758|NCT01383096|O10|Outcome|Cohort 3 - Treatement J: OZ439 800mg Prototype F1 Fasted|OZ439 800 mg (as free base) as prototype solution formulation 1. Administered fasted.
252759|NCT01383096|O9|Outcome|Cohort 2 - Treatement I: OZ349 800mg Prototype F2 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.
252760|NCT01383096|O8|Outcome|Cohort 2 - Treatement H: OZ439 800 mg Prototype F2 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered fasted.
252761|NCT01383096|O7|Outcome|Cohort 2 - Treatement G: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
252762|NCT01383096|O6|Outcome|Cohort 2 - Treatement F: OZ439 800 mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
252763|NCT01383096|O5|Outcome|Cohort 1 - Treatement E: OZ439 800mg Prototype F1 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.
252764|NCT01383096|O4|Outcome|Cohort 1 - Treatement D: OZ439 800 mg Prototype F1 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered fasted.
252765|NCT01383096|O3|Outcome|Cohort 1 - Treatment C:OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
252766|NCT01383096|O2|Outcome|Cohort 1 - Treatement B: OZ439 800mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
252767|NCT01383096|O1|Outcome|Cohort 1 - Treatement A: OZ439 800mg PIB Fed|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to administration. Administered 30 minutes after a standard fatty breakfast.
252768|NCT01383096|O11|Outcome|Cohort 3 - Treatment K: OZ439 400mg Prototype F1 Fasted|OZ439 400 mg as prototype solution formulation 1. Administered fasted.
252769|NCT01383096|O10|Outcome|Cohort 3 - Treatment J: OZ439 800mg Prototype F1 Fasted|OZ439 800 mg (as free base) as prototype solution formulation 1. Administered fasted.
252770|NCT01383096|O9|Outcome|Cohort 2 - Treatment I: OZ349 800mg Prototype F2 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.
252771|NCT01383096|O8|Outcome|Cohort 2 - Treatment H: OZ439 800 mg Prototype F2 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered fasted.
252772|NCT01383096|O7|Outcome|Cohort 2 - Treatment G: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
252773|NCT01383096|O6|Outcome|Cohort 2 - Treatment F: OZ439 800 mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted
252774|NCT01383096|O5|Outcome|Cohort 1 - Treatment E: OZ439 800mg Prototype F1 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered with milk.
252775|NCT01383096|O4|Outcome|Cohort 1 - Treatment D: OZ439 800 mg Prototype F1 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered fasted.
252776|NCT01383096|O3|Outcome|Cohort 1 - Treatment:OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
252777|NCT01383096|O2|Outcome|Cohort 1 - Treatment B: OZ439 800mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
252778|NCT01383096|O1|Outcome|Cohort 1 - Treatment A: OZ439 800mg PIB Fed|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to administration. Administered 30 minutes after a standard fatty breakfast.
252779|NCT01383096|E11|Reported Event|Cohort 3 - Treatment K: OZ439 400mg Prototype F1 Fasted|OZ439 400 mg as prototype solution formulation 1. Administered fasted.
252780|NCT01383096|E10|Reported Event|Cohort 3 - Treatment J: OZ439 800mg Prototype F1 Fasted|OZ439 800 mg (as free base) as prototype solution formulation 1. Administered fasted.
252781|NCT01383096|E9|Reported Event|Cohort 2 - Treatment I: OZ349 800mg Prototype F2 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.
252782|NCT01383096|E8|Reported Event|Cohort 2 - Treatment H: OZ439 800 mg Prototype F2 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered fasted.
252783|NCT01383096|E7|Reported Event|Cohort 2 - Treatment G: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
252784|NCT01383096|E6|Reported Event|Cohort 2 - Treatment F: OZ439 800 mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
252785|NCT01383096|E5|Reported Event|Cohort 1 - Treatment E: OZ439 800mg Prototype F1 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered with milk.
252786|NCT01383096|E4|Reported Event|Cohort 1 - Treatment D: OZ439 800 mg Prototype F1 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered fasted.
252787|NCT01383096|E3|Reported Event|Cohort 1 - Treatment C: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
252788|NCT01383096|E2|Reported Event|Cohort 1 - Treatment B: OZ439 800mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
252789|NCT01383096|E1|Reported Event|Cohort 1 - Treatment A: OZ439 800mg PIB Fed|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to administration. Administered 30 minutes after a standard fatty breakfast.
252790|NCT01383005|B3|Baseline|Total|Total of all reporting groups
252791|NCT01383005|B2|Baseline|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
252792|NCT01383005|B1|Baseline|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
252793|NCT01383005|P2|Participant Flow|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
252794|NCT01383005|P1|Participant Flow|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
252795|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
252796|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
252797|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
252798|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
252799|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
252931|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
252800|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
252801|NCT01383005|O2|Outcome|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
252802|NCT01383005|O1|Outcome|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
252803|NCT01383005|O2|Outcome|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
252804|NCT01383005|O1|Outcome|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
252805|NCT01383005|O2|Outcome|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
252806|NCT01383005|O1|Outcome|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
252807|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
252808|NCT01383005|O2|Outcome|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
252809|NCT01383005|O1|Outcome|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
252810|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
252811|NCT01383005|E1|Reported Event|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
252812|NCT01382940|B1|Baseline|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
252813|NCT01382940|P1|Participant Flow|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
252814|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
252815|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
252816|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
252817|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
252818|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
254121|NCT01378988|B3|Baseline|Total|Total of all reporting groups
252819|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
252820|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
252821|NCT01382940|E1|Reported Event|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
252822|NCT01382901|B3|Baseline|Total|Total of all reporting groups
252823|NCT01382901|B2|Baseline|Placebo|Intravenous (IV) solution of placebo on Day 0 and Day 5.
252824|NCT01382901|B1|Baseline|Ferric Carboxymaltose (FCM) 2 x 500 mg|500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
252825|NCT01382901|P2|Participant Flow|Placebo|Intravenous (IV) solution of placebo on Day 0 and Day 5.
252826|NCT01382901|P1|Participant Flow|Ferric Carboxymaltose (FCM) 2 x 500 mg|500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
252827|NCT01382901|O2|Outcome|Placebo|Intravenous (IV) solution of placebo on Day 0 and Day 5.
252828|NCT01382901|O1|Outcome|Ferric Carboxymaltose (FCM) 2 x 500 mg|500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
252829|NCT01382901|E2|Reported Event|Placebo|Intravenous (IV) solution of placebo on Day 0 and Day 5.
252830|NCT01382901|E1|Reported Event|Ferric Carboxymaltose (FCM) 2 x 500 mg|500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
252831|NCT01382719|B5|Baseline|Total|Total of all reporting groups
252832|NCT01382719|B4|Baseline|Bremelanotide Arm 3|high dose 1.75 mg BMT
252833|NCT01382719|B3|Baseline|Bremelanotide Arm 2|middle dose 1.25 mg BMT
252834|NCT01382719|B2|Baseline|Bremelanotide Arm 1|low dose 0.75 mg BMT
252835|NCT01382719|B1|Baseline|Placebo|identical formulation without active ingredient
252836|NCT01382719|P4|Participant Flow|Bremelanotide Arm 3|high dose 1.75 mg BMT
252837|NCT01382719|P3|Participant Flow|Bremelanotide Arm 2|middle dose 1.25 mg BMT
252838|NCT01382719|P2|Participant Flow|Bremelanotide Arm 1|low dose 0.75 mg BMT
252839|NCT01382719|P1|Participant Flow|Placebo|identical formulation without active ingredient
252840|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
252841|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
252842|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
252843|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
252844|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
252845|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
252846|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
252847|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
252848|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
252849|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
252850|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
252851|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
252852|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
252853|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
252854|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
252855|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
252856|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
252857|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
252858|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
252859|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
252860|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
252861|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
252862|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
252863|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
252864|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
252865|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
252866|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
252867|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
252868|NCT01382719|E4|Reported Event|Bremelanotide Arm 3|high dose 1.75 mg BMT
252869|NCT01382719|E3|Reported Event|Bremelanotide Arm 2|middle dose 1.25 mg BMT
252870|NCT01382719|E2|Reported Event|Bremelanotide Arm 1|low dose 0.75 mg BMT
252871|NCT01382719|E1|Reported Event|Placebo|identical formulation without active ingredient
252872|NCT01382602|B3|Baseline|Total|Total of all reporting groups
252873|NCT01382602|B2|Baseline|Placebo|Subjects received 1 or 2 treatments of placebo delivered via transurethral intrasphincteric injection.
252874|NCT01382602|B1|Baseline|AMDC-USR|Subjects received 1 or 2 treatments of 150 million AMDC-USR delivered via transurethral intrasphincteric injection.
252875|NCT01382602|P2|Participant Flow|Placebo|Subjects received 1 or 2 treatments of placebo delivered via transurethral intrasphincteric injection. After completing 12 months follow-up, subjects were unblinded and could elect to receive open-label AMDC-USR treatment. Subjects that received open-label AMDC-USR treatment were followed for 2 years after initial placebo treatment. Analysis population is based on subjects that received at least 1 treatment of placebo at the 12 months follow-up.
252927|NCT01382225|P1|Participant Flow|Sodium Hyaluronate|Run-in, followed by Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
252928|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
252876|NCT01382602|P1|Participant Flow|AMDC-USR|Subjects received 1 or 2 treatments of 150 million AMDC-USR delivered via transurethral intrasphincteric injection. After completing 12 months follow-up subjects were unblinded. Subjects were followed for 2 years after initial AMDC-USR treatment. Analysis population is based on subjects that received at least 1 treatment of AMDC-USR at the 12 months follow-up.
252877|NCT01382602|O2|Outcome|Placebo|Subjects received 1 or 2 treatments of placebo delivered via transurethral intrasphincteric injection.
252878|NCT01382602|O1|Outcome|AMDC-USR|Subjects received 1 or 2 treatments of 150 million AMDC-USR delivered via transurethral intrasphincteric injection.
252879|NCT01382602|E2|Reported Event|Placebo|Subjects received 1 or 2 treatments of placebo delivered via transurethral intrasphincteric injection. Analysis population is based on subjects that underwent at least 1 treatment of placebo, at the 12 month follow-up.
252880|NCT01382602|E1|Reported Event|AMDC-USR|Subjects received 1 or 2 treatments of 150 million AMDC-USR delivered via transurethral intrasphincteric injection. Analysis population is based on subjects that underwent at least 1 treatment of AMDC-USR, at the 12 month follow-up.
252881|NCT01382446|B3|Baseline|Total|Total of all reporting groups
252882|NCT01382446|B2|Baseline|Chlorhexidine Oral Care Regimen|Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
252883|NCT01382446|B1|Baseline|Standard Oral Care Regimen|Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.
252884|NCT01382446|P2|Participant Flow|Chlorhexidine Oral Care Regimen|Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
252885|NCT01382446|P1|Participant Flow|Standard Oral Care Regimen|Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.
252886|NCT01382446|O2|Outcome|Chlorhexidine Oral Care Regimen|Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
252887|NCT01382446|O1|Outcome|Standard Oral Care Regimen|Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.
252888|NCT01382446|E2|Reported Event|Chlorhexidine Oral Care Regimen|Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
252889|NCT01382446|E1|Reported Event|Standard Oral Care Regimen|Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.
252890|NCT01382303|B3|Baseline|Total|Total of all reporting groups
252891|NCT01382303|B2|Baseline|Placebo|"placebo tablet~Placebo: placebo tablet three times a day"
252892|NCT01382303|B1|Baseline|Pentoxifylline|"Pentoxifylline 400mg three times a day~Pentoxifylline: Pentoxifylline 400mg three times a day"
252893|NCT01382303|P2|Participant Flow|Placebo|"placebo tablet~Placebo: placebo tablet three times a day"
252894|NCT01382303|P1|Participant Flow|Pentoxifylline|"Pentoxifylline 400mg three times a day~Pentoxifylline: Pentoxifylline 400mg three times a day"
252895|NCT01382303|O2|Outcome|Placebo|"placebo tablet~Placebo: placebo tablet three times a day"
252896|NCT01382303|O1|Outcome|Pentoxifylline|"Pentoxifylline 400mg three times a day~Pentoxifylline: Pentoxifylline 400mg three times a day"
252897|NCT01382303|O2|Outcome|Placebo|"placebo tablet~Placebo: placebo tablet three times a day"
252898|NCT01382303|O1|Outcome|Pentoxifylline|"Pentoxifylline 400mg three times a day~Pentoxifylline: Pentoxifylline 400mg three times a day"
252899|NCT01382303|O2|Outcome|Placebo|"placebo tablet~Placebo: placebo tablet three times a day"
252900|NCT01382303|O1|Outcome|Pentoxifylline|"Pentoxifylline 400mg three times a day~Pentoxifylline: Pentoxifylline 400mg three times a day"
252901|NCT01382303|O2|Outcome|Placebo|"placebo tablet~Placebo: placebo tablet three times a day"
252902|NCT01382303|O1|Outcome|Pentoxifylline|"Pentoxifylline 400mg three times a day~Pentoxifylline: Pentoxifylline 400mg three times a day"
252903|NCT01382303|O2|Outcome|Placebo|"placebo tablet~Placebo: placebo tablet three times a day"
252904|NCT01382303|O1|Outcome|Pentoxifylline|"Pentoxifylline 400mg three times a day~Pentoxifylline: Pentoxifylline 400mg three times a day"
252905|NCT01382303|O2|Outcome|Placebo|"placebo tablet~Placebo: placebo tablet three times a day"
252906|NCT01382303|O1|Outcome|Pentoxifylline|"Pentoxifylline 400mg three times a day~Pentoxifylline: Pentoxifylline 400mg three times a day"
252907|NCT01382303|E2|Reported Event|Placebo|"placebo tablet~Placebo: placebo tablet three times a day"
252908|NCT01382303|E1|Reported Event|Pentoxifylline|"Pentoxifylline 400mg three times a day~Pentoxifylline: Pentoxifylline 400mg three times a day"
252909|NCT01382251|B3|Baseline|Total|Total of all reporting groups
252910|NCT01382251|B2|Baseline|Ambulatory Surgery Caregivers|Caregivers were recruited with the patients receiving surgery
252911|NCT01382251|B1|Baseline|Ambulatory Surgery Patients|Only patients with caregivers were recruited
252912|NCT01382251|P2|Participant Flow|Ambulatory Surgery Caregivers|
252913|NCT01382251|P1|Participant Flow|Ambulatory Surgery Patients|
252914|NCT01382251|O2|Outcome|Ambulatory Surgery Caregivers|
252915|NCT01382251|O1|Outcome|Ambulatory Surgery Patients|
252916|NCT01382251|O2|Outcome|Ambulatory Surgery Caregivers|
252917|NCT01382251|O1|Outcome|Ambulatory Surgery Patients|
252918|NCT01382251|O2|Outcome|Ambulatory Surgery Caregivers|
252919|NCT01382251|O1|Outcome|Ambulatory Surgery Patients|
252920|NCT01382251|O2|Outcome|Ambulatory Surgery Caregivers|
252921|NCT01382251|O1|Outcome|Ambulatory Surgery Patients|
252922|NCT01382251|E1|Reported Event|Ambulatory Surgery Patients|
252923|NCT01382225|B3|Baseline|Total|Total of all reporting groups
252924|NCT01382225|B2|Baseline|Vehicle|Run-in, followed by Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
252925|NCT01382225|B1|Baseline|Sodium Hyaluronate|Run-in, followed by Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
252926|NCT01382225|P2|Participant Flow|Vehicle|Run-in, followed by Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
252932|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
252933|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
252934|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
252935|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
252936|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
252937|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
252938|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
252939|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
252940|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
252941|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
252942|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
252943|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
252944|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
252945|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
252946|NCT01382225|E2|Reported Event|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
252947|NCT01382225|E1|Reported Event|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
252948|NCT01382212|B1|Baseline|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
252949|NCT01382212|P1|Participant Flow|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
252950|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
252951|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
252952|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
252953|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
252954|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
252955|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
252956|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
252957|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
252958|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
252959|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
252960|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
252961|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
252962|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
252963|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
252964|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
252965|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
252966|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
252967|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
252968|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
252969|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
252970|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
252971|NCT01382212|E1|Reported Event|Paricalcitol|Open-label paricalcitol (maximum dose of 16 μg), 3 times weekly (no more frequently than every other day) for 12 weeks.
252972|NCT01382186|B3|Baseline|Total|Total of all reporting groups
252973|NCT01382186|B2|Baseline|Random Sampling|Veterans registered for My HealtheVet and opted-in to use Secure Messaging from the Tampa, FL and Boston, MA areas.
252974|NCT01382186|B1|Baseline|Purposive Sampling|Veterans registered for My HealtheVet and opted-in to use Secure Messaging from the Tampa, FL and Boston, MA areas.
252975|NCT01382186|P2|Participant Flow|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
253027|NCT01381900|P2|Participant Flow|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
252976|NCT01382186|P1|Participant Flow|Purposive Sampling|Purposive sampling was used to identify a sample of 33 Veterans who have been Personally Authenticated for the SM feature on MHV. Participants were recruited from each site (Tampa, Boston). Women were purposively recruited to ensure females were represented in data findings.
252977|NCT01382186|O1|Outcome|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
252978|NCT01382186|O1|Outcome|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
252979|NCT01382186|O1|Outcome|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
252980|NCT01382186|O1|Outcome|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
252981|NCT01382186|O1|Outcome|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
252982|NCT01382186|O1|Outcome|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
252983|NCT01382186|O1|Outcome|Purposive Sampling|Purposive sampling was used to identify a sample of 33 Veterans who have been Personally Authenticated for the SM feature on MHV. Participants were recruited from each site (Tampa, Boston). Women were purposively recruited to ensure females were represented in data findings.
252984|NCT01382186|O3|Outcome|Purposive Sampling: Not Able to Complete Task|Veterans in this arm were not able to complete the task.
252985|NCT01382186|O2|Outcome|Purposive Sampling: Able to Complete Task With Difficulty|Veterans in this arm were able to complete task with some difficulty.
252986|NCT01382186|O1|Outcome|Purposive Sampling: Able to Complete Task|Veterans in this arm were able to complete the task.
252987|NCT01382186|E2|Reported Event|Random Sampling|Serious and other [non-serious] adverse events were not collected/assessed.
252988|NCT01382186|E1|Reported Event|Purposive Sampling|Serious and other [non-serious] adverse events were not collected/assessed.
252989|NCT01382108|B3|Baseline|Total|Total of all reporting groups
252990|NCT01382108|B2|Baseline|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
252991|NCT01382108|B1|Baseline|Normal Participants|Participants without meibomian gland dysfunction
252992|NCT01382108|P2|Participant Flow|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
252993|NCT01382108|P1|Participant Flow|Normal Participants|Participants without Meibomian Gland Dysfunction
252994|NCT01382108|O2|Outcome|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
252995|NCT01382108|O1|Outcome|Normal Participants|Participants without meibomian gland dysfunction
252996|NCT01382108|O2|Outcome|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
252997|NCT01382108|O1|Outcome|Normal Participants|Participants without meibomian gland dysfunction
252998|NCT01382108|O2|Outcome|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
252999|NCT01382108|O1|Outcome|Normal Participants|Participants without Meibomian Gland Dysfunction
253000|NCT01382108|E2|Reported Event|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
253001|NCT01382108|E1|Reported Event|Normal Participants|Participants without meibomian gland dysfunction
253002|NCT01381952|B1|Baseline|AlluraXper - ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
253003|NCT01381952|P1|Participant Flow|AlluraXper - ClarityIQ|Angiogram with AlluraXper subsequently followed by angiogram with ClarityIQ
253004|NCT01381952|O1|Outcome|AlluraXper - ClarityIQ|Angiogram with AlluraXper subsequently followed by angiogram with ClarityIQ
253005|NCT01381952|O1|Outcome|AlluraXper - ClarityIQ|Angiogram with AlluraXper subsequently followed by angiogram with ClarityIQ
253006|NCT01381952|O2|Outcome|Allura Clarity|Angiogram with AlluraXper followed by angiogram with ClarityIQ
253007|NCT01381952|O1|Outcome|AlluraXper|Angiogram with AlluraXper followed by angiogram with ClarityIQ
253008|NCT01381952|E1|Reported Event|AlluraXper - ClarityIQ|Angiogram with AlluraXper subsequently followed by angiogram with ClarityIQ
253009|NCT01381926|B3|Baseline|Total|Total of all reporting groups
253010|NCT01381926|B2|Baseline|Exenatide 1st Then Placebo|Study participants in period 1 will receive the study drug, exenatide, at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of exenatide will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no study medication will be given and this will serve as a “wash out” period prior to the second period of the study (placebo). During the fourth and fifth months, study participants will get placebo alternatives to exenatide 5mcg and exenatide 10mcg, respectively, subcutaneously twice daily before meals.
253011|NCT01381926|B1|Baseline|Placebo 1st Then Exenatide|Study participants in period1 will receive the saline placebo at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of saline placebo will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no treatment will be given and this will serve as a “wash out” period prior to the second periods of the study. During the fourth month participants will receive Exenatide 5mcg twice daily before meals. During the fifth month, study participants will get Exenatide 10mcg twice daily before meals.
253012|NCT01381926|P2|Participant Flow|Placebo 1st Then Exenatide|Study participants in periods1 will receive the saline placebo at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of saline placebo will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no treatment will be given and this will serve as a “wash out” period prior to the second periods of the study. During the fourth month participants will receive Exenatide 5mcg twice daily before meals. During the fifth month, study participants will get Exenatide 10mcg twice daily before meals.
253028|NCT01381900|P1|Participant Flow|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
261066|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
253013|NCT01381926|P1|Participant Flow|Exenatide 1st Then Placebo|Study participants in period 1 will receive the study drug, exenatide, at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of exenatide will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no study medication will be given and this will serve as a “wash out” period prior to the second period of the study (placebo). During the fourth and fifth months, study participants will get placebo alternatives to exenatide 5mcg and exenatide 10mcg, respectively, subcutaneously twice daily before meals.
253014|NCT01381926|O2|Outcome|Placebo 1st Then Exenatide|Study participants in phase1 will receive the saline placebo at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of saline placebo will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no treatment will be given and this will serve as a “wash out” period prior to the second phase of the study. During the fourth month participants will receive Exenatide 5mcg twice daily before meals. During the fifth month, study participants will get Exenatide 10mcg twice daily before meals.
253015|NCT01381926|O1|Outcome|Exenatide 1st Then Placebo|Study participants in phase1 will receive the study drug, exenatide, at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of exenatide will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no study medication will be given and this will serve as a “wash out” period prior to the second phase of the study (placebo). During the fourth and fifth months, study participants will get placebo alternatives to exenatide 5mcg and exenatide 10mcg, respectively, subcutaneously twice daily before meals.
253016|NCT01381926|O2|Outcome|Placebo Then Exenatide|"Study participants in phase1 will receive the saline placebo, at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the saline placebo will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no treatment will be given and this will serve as a “wash out” period prior to the second phase of the study. During the fourth month study participants will receive Exenatide 5mcg twice daily with meals. During the fifth month, study participants will receive exenatide 10mcg, subcutaneously twice daily before meals.~exenatide: exenatide 5mcg sq twice daily for one month and exenatide 10mcg twice daily for month 2. The 3rd month is a washout period. Month 4 and 5 saline placebo is given as 5mcg and 10mcg respectively."
253017|NCT01381926|O1|Outcome|Exenatide Then Placebo|"Study participants in phase1 will receive the study drug, exenatide, at a dose of 5mg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of exenatide will be increased to 10mg subcutaneously twice daily before meals for one month. During the third month of the study, no study medication will be given and this will serve as a “wash out” period prior to the second phase of the study (placebo). During the fourth and fifth months, study participants will get placebo alternatives to exenatide 5mg and exenatide 10mg, respectively, subcutaneously twice daily before meals.~exenatide: exenatide 5mcg sq twice daily for one month and exenatide 10mcg twice daily for month 2. The 3rd month is a washout period. Month 4 and 5 saline placebo is given as 5mcg and 10mcg respectively."
253018|NCT01381926|O2|Outcome|Placebo 1st Then Exenatide|Study participants in phase1 will receive the saline placebo at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of saline placebo will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no treatment will be given and this will serve as a “wash out” period prior to the second phase of the study. During the fourth month participants will receive Exenatide 5mcg twice daily before meals. During the fifth month, study participants will get Exenatide 10mcg twice daily before meals.
253019|NCT01381926|O1|Outcome|Exenatide 1st Then Placebo|Study participants in phase1 will receive the study drug, exenatide, at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of exenatide will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no study medication will be given and this will serve as a “wash out” period prior to the second phase of the study (placebo). During the fourth and fifth months, study participants will get placebo alternatives to exenatide 5mcg and exenatide 10mcg, respectively, subcutaneously twice daily before meals.
253020|NCT01381926|E2|Reported Event|Placebo 1st Then Exenatide|Study participants in phase1 will receive the saline placebo at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of saline placebo will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no treatment will be given and this will serve as a “wash out” period prior to the second phase of the study. During the fourth month participants will receive Exenatide 5mcg twice daily before meals. During the fifth month, study participants will get Exenatide 10mcg twice daily before meals.
253021|NCT01381926|E1|Reported Event|Exenatide 1st Then Placebo|Study participants in phase1 will receive the study drug, exenatide, at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of exenatide will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no study medication will be given and this will serve as a “wash out” period prior to the second phase of the study (placebo). During the fourth and fifth months, study participants will get placebo alternatives to exenatide 5mcg and exenatide 10mcg, respectively, subcutaneously twice daily before meals.
253022|NCT01381900|B4|Baseline|Total|Total of all reporting groups
253023|NCT01381900|B3|Baseline|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
253024|NCT01381900|B2|Baseline|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
253025|NCT01381900|B1|Baseline|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
253026|NCT01381900|P3|Participant Flow|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
261067|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
253029|NCT01381900|O3|Outcome|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
253030|NCT01381900|O2|Outcome|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
253031|NCT01381900|O1|Outcome|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
253032|NCT01381900|O3|Outcome|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
253033|NCT01381900|O2|Outcome|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
253034|NCT01381900|O1|Outcome|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
253035|NCT01381900|O3|Outcome|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
253036|NCT01381900|O2|Outcome|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
253037|NCT01381900|O1|Outcome|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
253038|NCT01381900|O3|Outcome|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
253039|NCT01381900|O2|Outcome|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
253040|NCT01381900|O1|Outcome|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
253041|NCT01381900|O3|Outcome|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
253042|NCT01381900|O2|Outcome|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
253043|NCT01381900|O1|Outcome|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
253044|NCT01381900|E3|Reported Event|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
253045|NCT01381900|E2|Reported Event|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
253046|NCT01381900|E1|Reported Event|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
253047|NCT01381679|B1|Baseline|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
253048|NCT01381679|P1|Participant Flow|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
253049|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
253050|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
253051|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
253052|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
253053|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
253054|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
253055|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
253056|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
253057|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
253058|NCT01381679|E1|Reported Event|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
253059|NCT01381575|B4|Baseline|Total|Total of all reporting groups
253060|NCT01381575|B3|Baseline|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253061|NCT01381575|B2|Baseline|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253062|NCT01381575|B1|Baseline|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
254122|NCT01378988|B2|Baseline|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
253063|NCT01381575|P3|Participant Flow|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253064|NCT01381575|P2|Participant Flow|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253065|NCT01381575|P1|Participant Flow|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253066|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253067|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253068|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253069|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253070|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253071|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253072|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253073|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253074|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253075|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253076|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253077|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253078|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253079|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253080|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253081|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253082|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253083|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253084|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253085|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253086|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253087|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253362|NCT01380782|O1|Outcome|Arm A (Bevacizumab-naive) - GBM|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was glioblastoma (GBM).
253088|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253089|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253090|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253091|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253092|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253093|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253094|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253095|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253096|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253097|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253098|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253099|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253100|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253101|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253102|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253103|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253104|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253105|NCT01381575|O1|Outcome|Cervarix1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253106|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253107|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253108|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253109|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253110|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253111|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253112|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253113|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253114|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253115|NCT01381575|E3|Reported Event|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253116|NCT01381575|E2|Reported Event|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253117|NCT01381575|E1|Reported Event|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
253118|NCT01381562|B4|Baseline|Total|Total of all reporting groups
253119|NCT01381562|B3|Baseline|Meropenem 1 g|Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253120|NCT01381562|B2|Baseline|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253121|NCT01381562|B1|Baseline|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253122|NCT01381562|P3|Participant Flow|Meropenem 1.0 g|Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253123|NCT01381562|P2|Participant Flow|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253124|NCT01381562|P1|Participant Flow|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 millilitre (mL) saline solution as intravenous (IV) infusion administered over 60 minutes, twice a day (BID) and meropenem matching placebo solution, 100 ml, administered over 30 minutes, thrice a day (TID) from Day 2 to Day 14 of the study.
253125|NCT01381562|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253126|NCT01381562|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253127|NCT01381562|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253128|NCT01381562|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253129|NCT01381562|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253130|NCT01381562|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253131|NCT01381562|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253132|NCT01381562|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253133|NCT01381562|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253134|NCT01381562|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253135|NCT01381562|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253136|NCT01381562|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253137|NCT01381562|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253138|NCT01381562|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
261068|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
253139|NCT01381562|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253140|NCT01381562|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253141|NCT01381562|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253142|NCT01381562|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253143|NCT01381562|O3|Outcome|Meropenem 1g|Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253144|NCT01381562|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253145|NCT01381562|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253146|NCT01381562|O3|Outcome|Meropenem 1g|Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253147|NCT01381562|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253148|NCT01381562|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253149|NCT01381562|O3|Outcome|Meropenem 1g|Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253150|NCT01381562|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253151|NCT01381562|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253152|NCT01381562|O3|Outcome|Meropenem 1g|Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253153|NCT01381562|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253154|NCT01381562|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253155|NCT01381562|O3|Outcome|Meropenem 1g|Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253156|NCT01381562|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253157|NCT01381562|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253158|NCT01381562|O3|Outcome|Meropenem 1g|Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253159|NCT01381562|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253160|NCT01381562|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253161|NCT01381562|O3|Outcome|Meropenem 1g|Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253162|NCT01381562|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253406|NCT01380730|O5|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253163|NCT01381562|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253164|NCT01381562|O3|Outcome|Meropenem 1g|Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253165|NCT01381562|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253166|NCT01381562|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253167|NCT01381562|O3|Outcome|Meropenem 1g|Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253168|NCT01381562|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253169|NCT01381562|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253170|NCT01381562|O3|Outcome|Meropenem 1g|Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253171|NCT01381562|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253172|NCT01381562|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253173|NCT01381562|O3|Outcome|Meropenem 1g|Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253174|NCT01381562|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253175|NCT01381562|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253176|NCT01381562|O3|Outcome|Meropenem 1g|Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253177|NCT01381562|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253178|NCT01381562|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253179|NCT01381562|O3|Outcome|Meropenem 1g|Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253180|NCT01381562|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253181|NCT01381562|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253182|NCT01381562|O3|Outcome|Meropenem 1g|Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253183|NCT01381562|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253184|NCT01381562|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253185|NCT01381562|E3|Reported Event|Meropenem 1g|Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253186|NCT01381562|E2|Reported Event|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
254123|NCT01378988|B1|Baseline|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
253187|NCT01381562|E1|Reported Event|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.
253188|NCT01381549|B4|Baseline|Total|Total of all reporting groups
253189|NCT01381549|B3|Baseline|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253190|NCT01381549|B2|Baseline|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253191|NCT01381549|B1|Baseline|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253192|NCT01381549|P3|Participant Flow|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253193|NCT01381549|P2|Participant Flow|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253194|NCT01381549|P1|Participant Flow|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 milligram (mg), in 200 or 250 millilitre (mL) saline solution as intravenous (IV) infusion administered over 60 minutes, twice a day (BID) and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253195|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253196|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253197|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, twice a day (BID) and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253198|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253199|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253200|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, twice a day (BID) and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253201|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253202|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253203|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, twice a day (BID) and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253204|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253205|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253206|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, twice a day (BID) and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253207|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253208|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253363|NCT01380782|O1|Outcome|Arm B (Bevacizumab Treated) - GBM|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was glioblastoma (GBM).
253209|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, twice a day (BID) and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253210|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253211|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253212|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, twice a day (BID) and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253213|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253214|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253215|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, twice a day (BID) and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253216|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253217|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253218|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, twice a day (BID) and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253219|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253220|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253221|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, twice a day (BID) and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253222|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253223|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253224|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, twice a day (BID) and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253225|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253226|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253227|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, twice a day (BID) and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253228|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253229|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253274|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253230|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, twice a day (BID) and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253231|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253232|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253233|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253234|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253235|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253236|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253237|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253238|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253239|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253240|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253241|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253242|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253243|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253244|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253245|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253246|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253247|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253248|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253249|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253250|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253251|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, twice a day (BID) and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253252|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253253|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253254|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, twice a day (BID) and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253255|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253256|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253257|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, twice a day (BID) and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253258|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253259|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253260|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, twice a day (BID) and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253261|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253262|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253263|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, twice a day (BID) and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253264|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253265|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253266|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253267|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253268|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253269|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253270|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253271|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253272|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253273|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253275|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253276|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253277|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253278|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253279|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253280|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253281|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253282|NCT01381549|O3|Outcome|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253283|NCT01381549|O2|Outcome|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253284|NCT01381549|O1|Outcome|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253285|NCT01381549|E3|Reported Event|Imipenem-Cilastatin|Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
253286|NCT01381549|E2|Reported Event|GSK2251052 1500 mg|Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253287|NCT01381549|E1|Reported Event|GSK2251052 750 mg|Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, twice a day (BID) and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
253288|NCT01381471|B1|Baseline|Fluticasone Propionate/Salmeterol (FSC)|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification [ICD-9] codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one1 pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)
253289|NCT01381471|P1|Participant Flow|Fluticasone Propionate/Salmeterol (FSC)|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)
253290|NCT01381471|O1|Outcome|Fluticasone Propionate/Salmeterol (FSC)|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification [ICD-9] codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one1 pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)
253291|NCT01381471|O1|Outcome|Fluticasone Propionate/Salmeterol (FSC)|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification [ICD-9] codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one1 pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)
253292|NCT01381471|E1|Reported Event|Fluticasone Propionate/Salmeterol (FSC)|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)
253293|NCT01381406|B3|Baseline|Total|Total of all reporting groups
253294|NCT01381406|B2|Baseline|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
253295|NCT01381406|B1|Baseline|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period.
269061|NCT01333397|O3|Outcome|Dysport NG 50 U|
253296|NCT01381406|P2|Participant Flow|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
253297|NCT01381406|P1|Participant Flow|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period
253298|NCT01381406|O2|Outcome|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
253299|NCT01381406|O1|Outcome|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period.
253300|NCT01381406|O2|Outcome|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
253301|NCT01381406|O1|Outcome|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period.
253302|NCT01381406|O2|Outcome|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
253303|NCT01381406|O1|Outcome|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period.
253304|NCT01381406|E2|Reported Event|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
253305|NCT01381406|E1|Reported Event|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period.
253306|NCT01381120|B3|Baseline|Total|Total of all reporting groups
253307|NCT01381120|B2|Baseline|Narcotic Painkiller|
253308|NCT01381120|B1|Baseline|VESIcare + Narcotic Painkiller|
253309|NCT01381120|P2|Participant Flow|Narcotic Painkiller|
253310|NCT01381120|P1|Participant Flow|VESIcare + Narcotic Painkiller|
253311|NCT01381120|O2|Outcome|Narcotic Painkiller|Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
253312|NCT01381120|O1|Outcome|VESIcare + Narcotic Painkiller|VESIcare: Dosage form: tablet, film coated Dosage: 5 mg Frequency: daily Duration: three months Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
253313|NCT01381120|O2|Outcome|Narcotic Painkiller|Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
253314|NCT01381120|O1|Outcome|VESIcare + Narcotic Painkiller|VESIcare: Dosage form: tablet, film coated Dosage: 5 mg Frequency: daily Duration: three months Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
253315|NCT01381120|E2|Reported Event|Narcotic Painkiller|
253316|NCT01381120|E1|Reported Event|VESIcare + Narcotic Painkiller|
253317|NCT01381016|B3|Baseline|Total|Total of all reporting groups
253318|NCT01381016|B2|Baseline|Experimental|"Group 2 Experimental: Obese (BMI >30 kg/m2)~Estradiol, Lutrelef or gonadorelin"
253319|NCT01381016|B1|Baseline|Control|"Group 1 Control: Normal weight (BMI 18-25 kg/m2)~Estradiol, Lutrelef or gonadorelin"
253320|NCT01381016|P2|Participant Flow|Experimental|"Group 2 Experimental: Obese (BMI >30 kg/m2)~Estradiol, Lutrelef or gonadorelin"
253321|NCT01381016|P1|Participant Flow|Control|"Group 1 Control: Normal weight (BMI 18-25 kg/m2)~Estradiol, Lutrelef or gonadorelin"
253322|NCT01381016|O2|Outcome|Experimental|"Group 2: Obese (BMI >30 kg/m2)~Estradiol, Lutrelef or gonadorelin"
253323|NCT01381016|O1|Outcome|Control|"Group 1: Normal weight (BMI 18-25 kg/m2)~Estradiol, Lutrelef or gonadorelin"
253324|NCT01381016|O2|Outcome|Group 2 - Obese|"Group 2: Obese (BMI >30 kg/m2)~Estradiol, Lutrelef or gonadorelin"
253325|NCT01381016|O1|Outcome|Group 1 - Normal Weight|"Group 1: Normal weight (BMI 18-25 kg/m2)~Estradiol, Lutrelef or gonadorelin"
253326|NCT01381016|E2|Reported Event|Experimental|"Group 2 Experimental: Obese (BMI >30 kg/m2)~Estradiol, Lutrelef or gonadorelin"
253327|NCT01381016|E1|Reported Event|Control|"Group 1 Control: Normal weight (BMI 18-25 kg/m2)~Estradiol, Lutrelef or gonadorelin"
253328|NCT01380834|B3|Baseline|Total|Total of all reporting groups
253329|NCT01380834|B2|Baseline|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.~control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
253330|NCT01380834|B1|Baseline|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.~treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
253331|NCT01380834|P2|Participant Flow|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.~control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
253332|NCT01380834|P1|Participant Flow|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.~treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
253361|NCT01380782|O2|Outcome|Arm A (Bevacizumab-naive) - AG|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was anaplastic glioma (AG).
254124|NCT01378988|P2|Participant Flow|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
253333|NCT01380834|O2|Outcome|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.~control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
253334|NCT01380834|O1|Outcome|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.~treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
253335|NCT01380834|O2|Outcome|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.~control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
253336|NCT01380834|O1|Outcome|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.~treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
253337|NCT01380834|O2|Outcome|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.~control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
253338|NCT01380834|O1|Outcome|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.~treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
253339|NCT01380834|E2|Reported Event|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.~control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
253340|NCT01380834|E1|Reported Event|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.~treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
253341|NCT01380782|B3|Baseline|Total|Total of all reporting groups
253342|NCT01380782|B2|Baseline|Arm B Bevacizumab-treated|Bevacizumab-treated participants
253343|NCT01380782|B1|Baseline|Arm A Bevacizumab-naive|Bevacizumab-naive participants
253344|NCT01380782|P4|Participant Flow|Arm B (Bevacizumab Treated) - AG|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was anaplastic glioma (AG).
253345|NCT01380782|P3|Participant Flow|Arm B (Bevacizumab Treated) - GBM|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was glioblastoma (GBM).
253346|NCT01380782|P2|Participant Flow|Arm A (Bevacizumab-naive) - AG|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was anaplastic glioma (AG).
253347|NCT01380782|P1|Participant Flow|Arm A (Bevacizumab-naive) - GBM|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was glioblastoma (GBM).
253348|NCT01380782|O2|Outcome|Arm B (Bevacizumab Treated) - AG|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was anaplastic glioma (AG).
253349|NCT01380782|O1|Outcome|Arm A (Bevacizumab-naive) - AG|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was anaplastic glioma (AG).
253350|NCT01380782|O1|Outcome|All Participants (Arm A and B)|
253351|NCT01380782|O4|Outcome|Arm B (Bevacizumab Treated) - AG|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was anaplastic glioma (AG).
253352|NCT01380782|O3|Outcome|Arm B (Bevacizumab Treated) - GBM|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was glioblastoma (GBM).
253353|NCT01380782|O2|Outcome|Arm A (Bevacizumab-naive) - AG|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was anaplastic glioma (AG).
253354|NCT01380782|O1|Outcome|Arm A (Bevacizumab-naive) - GBM|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was glioblastoma (GBM).
253355|NCT01380782|O4|Outcome|Arm B (Bevacizumab Treated) - AG|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was anaplastic glioma (AG).
253356|NCT01380782|O3|Outcome|Arm B (Bevacizumab Treated) - GBM|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was glioblastoma (GBM).
253357|NCT01380782|O2|Outcome|Arm A (Bevacizumab-naive) - AG|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was anaplastic glioma (AG).
253358|NCT01380782|O1|Outcome|Arm A (Bevacizumab-naive) - GBM|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was glioblastoma (GBM).
253359|NCT01380782|O4|Outcome|Arm B (Bevacizumab Treated) - AG|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was anaplastic glioma (AG).
253360|NCT01380782|O3|Outcome|Arm B (Bevacizumab Treated) - GBM|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was glioblastoma (GBM).
253364|NCT01380782|O1|Outcome|Arm A (Bevacizumab-naive) - GBM|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was glioblastoma (GBM).
253365|NCT01380782|E2|Reported Event|Arm B|Bevacizumab-treated participants
253366|NCT01380782|E1|Reported Event|Arm A|Bevacizumab-naive participants
253367|NCT01380769|B3|Baseline|Total|Total of all reporting groups
253368|NCT01380769|B2|Baseline|BSC (Best Supportive Care) Alone|Standard therapy consisting of best supportive care (BSC), including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required.
253369|NCT01380769|B1|Baseline|CRLX101 + BSC (Best Supportive Care)|15 mg/m2 CRLX101 infused IV over 60 minutes every other week + Standard therapy consisting of best supportive care (BSC), including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required.
253370|NCT01380769|P2|Participant Flow|BSC (Best Supportive Care) Alone|Standard therapy consisting of best supportive care (BSC), including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required.
253371|NCT01380769|P1|Participant Flow|CRLX101 + BSC (Best Supportive Care)|15 mg/m2 CRLX101 infused IV over 60 minutes every other week + Standard therapy consisting of best supportive care (BSC), including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required.
253372|NCT01380769|O2|Outcome|Best Supportive Care|Best Supportive Care: best supportive care
253373|NCT01380769|O1|Outcome|CRLX101|CRLX101: CRLX101 is administered at 15mg/m2 IV every other week
253374|NCT01380769|O2|Outcome|Best Supportive Care|Best Supportive Care: best supportive care
253375|NCT01380769|O1|Outcome|CRLX101|CRLX101: CRLX101 is administered at 15mg/m2 IV every other week
253376|NCT01380769|E2|Reported Event|Best Supportive Care (BSC) Only|Standard therapy consisting of best supportive care, including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required.
253377|NCT01380769|E1|Reported Event|CRLX101+BSC|15 mg/m2 CRLX101 infused IV over 60 minutes every other week + Standard therapy consisting of best supportive care, including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required.
253378|NCT01380730|B9|Baseline|Total|Total of all reporting groups
253379|NCT01380730|B8|Baseline|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
253380|NCT01380730|B7|Baseline|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
253381|NCT01380730|B6|Baseline|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
253382|NCT01380730|B5|Baseline|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253383|NCT01380730|B4|Baseline|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253384|NCT01380730|B3|Baseline|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253385|NCT01380730|B2|Baseline|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
253386|NCT01380730|B1|Baseline|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
253387|NCT01380730|P8|Participant Flow|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
253388|NCT01380730|P7|Participant Flow|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
253389|NCT01380730|P6|Participant Flow|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
253390|NCT01380730|P5|Participant Flow|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253391|NCT01380730|P4|Participant Flow|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253392|NCT01380730|P3|Participant Flow|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253393|NCT01380730|P2|Participant Flow|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
253394|NCT01380730|P1|Participant Flow|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
253395|NCT01380730|O8|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
253396|NCT01380730|O7|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
253397|NCT01380730|O6|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
253398|NCT01380730|O5|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253399|NCT01380730|O4|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253400|NCT01380730|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253401|NCT01380730|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
253402|NCT01380730|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
253403|NCT01380730|O8|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
253404|NCT01380730|O7|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
253405|NCT01380730|O6|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
269062|NCT01333397|O2|Outcome|Dysport NG 20 U|
253407|NCT01380730|O4|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253408|NCT01380730|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253409|NCT01380730|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
253410|NCT01380730|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
253411|NCT01380730|O8|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
253412|NCT01380730|O7|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
253413|NCT01380730|O6|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
253414|NCT01380730|O5|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253415|NCT01380730|O4|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253416|NCT01380730|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253417|NCT01380730|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
253418|NCT01380730|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
253419|NCT01380730|O8|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
253420|NCT01380730|O7|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
253421|NCT01380730|O6|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
253422|NCT01380730|O5|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253423|NCT01380730|O4|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253424|NCT01380730|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253425|NCT01380730|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
253426|NCT01380730|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
253427|NCT01380730|O8|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
253428|NCT01380730|O7|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
253429|NCT01380730|O6|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
253430|NCT01380730|O5|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253431|NCT01380730|O4|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253432|NCT01380730|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253433|NCT01380730|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
253434|NCT01380730|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
253435|NCT01380730|O8|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
253436|NCT01380730|O7|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
253437|NCT01380730|O6|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
253438|NCT01380730|O5|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253439|NCT01380730|O4|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253440|NCT01380730|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253441|NCT01380730|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
253442|NCT01380730|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
253443|NCT01380730|E8|Reported Event|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
253444|NCT01380730|E7|Reported Event|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
253445|NCT01380730|E6|Reported Event|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
253446|NCT01380730|E5|Reported Event|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253447|NCT01380730|E4|Reported Event|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253448|NCT01380730|E3|Reported Event|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
253449|NCT01380730|E2|Reported Event|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
253450|NCT01380730|E1|Reported Event|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
253451|NCT01380639|B3|Baseline|Total|Total of all reporting groups
253452|NCT01380639|B2|Baseline|Rehabilitation Without Vibration Training|
254125|NCT01378988|P1|Participant Flow|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
253453|NCT01380639|B1|Baseline|Rehabilitation With Vibration Training|whole body vibration training : performing squats for 3x3 minutes while using vibration platform three times a week
253454|NCT01380639|P2|Participant Flow|Rehabilitation Without Vibration Training|
253455|NCT01380639|P1|Participant Flow|Rehabilitation With Vibration Training|whole body vibration training : performing squats for 3x3 minutes while using vibration platform three times a week
253456|NCT01380639|O2|Outcome|Rehabilitation Without Vibration Training|
253457|NCT01380639|O1|Outcome|Rehabilitation With Vibration Training|whole body vibration training : performing squats for 3x3 minutes while using vibration platform three times a week
253458|NCT01380639|E2|Reported Event|Rehabilitation Without Vibration Training|
253459|NCT01380639|E1|Reported Event|Rehabilitation With Vibration Training|whole body vibration training : performing squats for 3x3 minutes while using vibration platform three times a week
253460|NCT01380379|B1|Baseline|Life Skills and Self-defense Training|"Women will participate in a therapeutic group which covers education, skills, and empowerment activities.~Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing."
253461|NCT01380379|P1|Participant Flow|Life Skills and Self-defense Training|"Women will participate in a therapeutic group which covers education, skills, and empowerment activities.~Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing."
253462|NCT01380379|O1|Outcome|Life Skills and Self-defense Training|"Women will participate in a therapeutic group which covers education, skills, and empowerment activities.~Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing."
253463|NCT01380379|O1|Outcome|Life Skills and Self-defense Training|"Women will participate in a therapeutic group which covers education, skills, and empowerment activities.~Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing."
253464|NCT01380379|E1|Reported Event|Life Skills and Self-defense Training|"Women will participate in a therapeutic group which covers education, skills, and empowerment activities.~Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing."
253465|NCT01380366|B1|Baseline|Patients Consented to be Given rHGH|Patients given growth hormone (rHGH) for their short bowel syndrome.
253466|NCT01380366|P1|Participant Flow|Zorptive Subjects|Patients consent to rHGH and Intestinal Permeability in Intestinal Failure Study
253467|NCT01380366|O1|Outcome|Patient Decreased Liver Injury|Results that show decreased liver injury (ALT, AST, bilirubin, alkaline phosphate (ALK or ALP), GGT) will show Zorbtive administration enhanced intestinal permeability and enhanced liver function.
253468|NCT01380366|O1|Outcome|Patients Experiencing Decrease in Concentration of Sucralose|A decrease in concentration of sucralose in urine indicates Zorbtive potentially enhancing intestinal barrier function.
253469|NCT01380366|E1|Reported Event|Patients Consented to be Given rHGH|Patients given growth hormone (rHGH) for their short bowel syndrome.
253470|NCT01380327|B4|Baseline|Total|Total of all reporting groups
253471|NCT01380327|B3|Baseline|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
253472|NCT01380327|B2|Baseline|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
253473|NCT01380327|B1|Baseline|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
253474|NCT01380327|P3|Participant Flow|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
253475|NCT01380327|P2|Participant Flow|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
253476|NCT01380327|P1|Participant Flow|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
253477|NCT01380327|O3|Outcome|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
253478|NCT01380327|O2|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
253479|NCT01380327|O1|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
253480|NCT01380327|O3|Outcome|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
253481|NCT01380327|O2|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
253482|NCT01380327|O1|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
253483|NCT01380327|O3|Outcome|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
253484|NCT01380327|O2|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
253485|NCT01380327|O1|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
253486|NCT01380327|O3|Outcome|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
253487|NCT01380327|O2|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
253488|NCT01380327|O1|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
253489|NCT01380327|O3|Outcome|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
253565|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
269063|NCT01333397|O1|Outcome|Placebo|
253490|NCT01380327|O2|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
253491|NCT01380327|O1|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
253492|NCT01380327|E3|Reported Event|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily or twice-daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
253493|NCT01380327|E2|Reported Event|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
253494|NCT01380327|E1|Reported Event|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) twice-daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
253495|NCT01380197|B3|Baseline|Total|Total of all reporting groups
253496|NCT01380197|B2|Baseline|Randomization to Nubain|"Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients~Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
253497|NCT01380197|B1|Baseline|Randomizing Particiipants to Morphine|"Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis~Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
253498|NCT01380197|P2|Participant Flow|Randomization to Nubain|"Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients~Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
253499|NCT01380197|P1|Participant Flow|Randomizing Particiipants to Morphine|"Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis~Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
253500|NCT01380197|O2|Outcome|Randomization to Nubain|"Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients~Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
253501|NCT01380197|O1|Outcome|Randomizing Particiipants to Morphine|"Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis~Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
253502|NCT01380197|O2|Outcome|Randomization to Nubain|"Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients~Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
253503|NCT01380197|O1|Outcome|Randomizing Particiipants to Morphine|"Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis~Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
253504|NCT01380197|E2|Reported Event|Randomization to Nubain|"Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients~Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
253505|NCT01380197|E1|Reported Event|Randomizing Particiipants to Morphine|"Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis~Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
253506|NCT01380145|B1|Baseline|All Enrolled Subjects|Includes all subjects enrolled in the study.
253507|NCT01380145|P1|Participant Flow|All Enrolled Subjects|Subjects received a total of 8 pre- and post-auto-SCT immunizations with recMAGE-A3 + AS15 administered intramuscularly at a dose of 300 µg recMAGE-A3, with no dose adjustments permitted. The first immunization was administered 6 to 15 week prior to auto-SCT, with subsequent immunizations administered on Days 10, 31, 52, 73, and 94 (± 3 days) and Days 180 and 270 (± 7 days) after auto-SCT.
253508|NCT01380145|O1|Outcome|Evaluable Analysis Set|Includes all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline disease assessment.
253509|NCT01380145|O1|Outcome|Evaluable Analysis Set|Includes all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline disease assessment.
253510|NCT01380145|O1|Outcome|Immunogenicity Analysis Set|Includes all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline immunity assessment.
253511|NCT01380145|O1|Outcome|Immunogenicity Analysis Set|Includes all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline immunity assessment.
253512|NCT01380145|O1|Outcome|Safety Analysis Set|Includes all subjects who received at least 1 immunization with study drug.
253513|NCT01380145|E1|Reported Event|Safety Analysis Set|Includes all subjects who received at least 1 immunization with study drug.
253514|NCT01380093|B1|Baseline|Entire Study Population|Includes all participants enrolled in the study.
253515|NCT01380093|P9|Participant Flow|EMBEDA Then Placebo Then Morphine|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in first intervention period; followed by single dose of matching placebo solution orally in second intervention period; then single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
253516|NCT01380093|P8|Participant Flow|Placebo Then Morphine Then EMBEDA|Single dose of matching placebo solution orally in first intervention period; followed by single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in second intervention period; then single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
253517|NCT01380093|P7|Participant Flow|Morphine Then EMBEDA Then Placebo|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in first intervention period; followed by single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in second intervention period; then single dose of matching placebo solution orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
253518|NCT01380093|P6|Participant Flow|Morphine Then Placebo Then EMBEDA|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in first intervention period; followed by single dose of matching placebo solution orally in second intervention period; then single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
253519|NCT01380093|P5|Participant Flow|EMBEDA Then Morphine Then Placebo|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in first intervention period; followed by single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in second intervention period; then single dose of matching placebo solution orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
253520|NCT01380093|P4|Participant Flow|Placebo Then EMBEDA Then Morphine|Single dose of matching placebo solution orally in first intervention period; followed by single dose of solution of EMBEDA extended release (ER) capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in second intervention period; then single dose of solution of morphine sulfate (MS Contin) controlled release (CR) tablet 120 mg orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
253521|NCT01380093|P3|Participant Flow|Placebo Then Morphine|Single dose of matching placebo solution orally on Day 1 followed by single dose of morphine sulfate 120 mg solution orally on Day 2. Participants in this group were assigned to morphine, placebo and EMBEDA in either of the 6 sequences in the treatment phase of the study.
253522|NCT01380093|P2|Participant Flow|Morphine Then Placebo|Single dose of morphine sulfate 120 mg solution orally on Day 1 followed by single dose of matching placebo solution orally on Day 2. Participants in this group were assigned to morphine, placebo and EMBEDA in either of the 6 sequences in the treatment phase of the study.
253523|NCT01380093|P1|Participant Flow|Naloxone|Naloxone hydrochloride 0.2 milligram (mg) intravenously (IV) followed by additional 0.6 mg naloxone hydrochloride IV, each dose followed by an assessment for signs of withdrawal. Participants in this group were assigned to either morphine then placebo or placebo then morphine in the drug discrimination phase of the study.
253524|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253525|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253526|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253527|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253528|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253529|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253566|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253530|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253531|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253532|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253533|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253534|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253535|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253536|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253537|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253538|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253539|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253540|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253541|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253542|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253543|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253544|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253545|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253546|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253547|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253548|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253549|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253550|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253551|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253552|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253553|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253554|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253555|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253556|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253557|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253558|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253559|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253560|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253561|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253562|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253563|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253564|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
261069|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
253567|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253568|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253569|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253570|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253571|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253572|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253573|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253574|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253575|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253576|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253577|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253578|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253579|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253580|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253581|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253582|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253583|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253584|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253585|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253586|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253587|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253588|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253589|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253590|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253591|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253592|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253593|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253594|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253595|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253596|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253597|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253598|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253599|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253600|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253601|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253602|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253603|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253604|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253605|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
269064|NCT01333397|O5|Outcome|Dysport 50 U|
253606|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253607|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253608|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253609|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253610|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253611|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253612|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253613|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253614|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253615|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253616|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253617|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253618|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253619|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253620|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253621|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253622|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253623|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253624|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253625|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253626|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253627|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253628|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253629|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253630|NCT01380093|O2|Outcome|EMBEDA|Single dose of EMBEDA solution containing 120 mg morphine sulfate / 4.8 mg naltrexone hydrochloride administered orally in either of the first to third intervention periods.
253631|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253632|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253633|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253634|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253635|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253636|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253637|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253638|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253639|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253640|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253641|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253642|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253643|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253644|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
269065|NCT01333397|O4|Outcome|Dysport NG 75 U|
253645|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253646|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253647|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253648|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253649|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253650|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253651|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253652|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253653|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253654|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253655|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253656|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253657|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253658|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253659|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253660|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253661|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253662|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253663|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253664|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253665|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253666|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253667|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253668|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253669|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253670|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253671|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253672|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253673|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253674|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253675|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253676|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253677|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253678|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253679|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253680|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253681|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253682|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253683|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
269066|NCT01333397|O3|Outcome|Dysport NG 50 U|
253684|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253685|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253686|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253687|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253688|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253689|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253690|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253691|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253692|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253693|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253694|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253695|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253696|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253697|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253698|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253699|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253700|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253701|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253702|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253703|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253704|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253705|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253706|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253707|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253708|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253709|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253710|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253711|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253712|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253713|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253714|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253715|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253716|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253717|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253718|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253719|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253720|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253721|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253722|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
269067|NCT01333397|O2|Outcome|Dysport NG 20 U|
253723|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253724|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253725|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253726|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253727|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253728|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253729|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253730|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253731|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253732|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253733|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253734|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253735|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253736|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253737|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253738|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253739|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253740|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253741|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253742|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253743|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253744|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253745|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253746|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253747|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253748|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253749|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253750|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253751|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253752|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253753|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253754|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253755|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253756|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253757|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253758|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253759|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253760|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253761|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
269068|NCT01333397|O1|Outcome|Placebo|
253762|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253763|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253764|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253765|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253766|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253767|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253768|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253769|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253770|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253771|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253772|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253773|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253774|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253775|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253776|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253777|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253778|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253779|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253780|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253781|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253782|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253783|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253784|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253785|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253786|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253787|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253788|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253789|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253790|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253791|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253792|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253793|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253794|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253795|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253796|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253797|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253798|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253799|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253800|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
269069|NCT01333397|O4|Outcome|Dysport NG 75 U|
253801|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253802|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253803|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253804|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253805|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253806|NCT01380093|E6|Reported Event|Morphine (Treatment Phase)|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
253807|NCT01380093|E5|Reported Event|EMBEDA (Treatment Phase)|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
253808|NCT01380093|E4|Reported Event|Placebo (Treatment Phase)|Single dose of matching placebo solution orally in either of the first to third intervention periods.
253809|NCT01380093|E3|Reported Event|Morphine (Drug Discrimination Phase)|Single dose of morphine sulfate 120 mg solution orally on Day 1 or 2.
253810|NCT01380093|E2|Reported Event|Placebo (Drug Discrimination Phase)|Single dose of matching placebo solution orally on Day 1 or 2.
253811|NCT01380093|E1|Reported Event|Naloxone (Naloxone Challenge Phase)|Naloxone hydrochloride 0.2 mg IV followed by additional 0.6 mg naloxone hydrochloride IV, each dose followed by an assessment for signs of withdrawal.
253812|NCT01380080|B3|Baseline|Total|Total of all reporting groups
253813|NCT01380080|B2|Baseline|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
253814|NCT01380080|B1|Baseline|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
253815|NCT01380080|P2|Participant Flow|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
253816|NCT01380080|P1|Participant Flow|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
253817|NCT01380080|O2|Outcome|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
253818|NCT01380080|O1|Outcome|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
253819|NCT01380080|O2|Outcome|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
253854|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253820|NCT01380080|O1|Outcome|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
253821|NCT01380080|O2|Outcome|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
253822|NCT01380080|O1|Outcome|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
253823|NCT01380080|O2|Outcome|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
253824|NCT01380080|O1|Outcome|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
253825|NCT01380080|O2|Outcome|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
253826|NCT01380080|O1|Outcome|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
253827|NCT01380080|O2|Outcome|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
253828|NCT01380080|O1|Outcome|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
253829|NCT01380080|E2|Reported Event|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
253855|NCT01379937|O2|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
254029|NCT01379664|O1|Outcome|Isoflurane|"Isoflurane is to be administered to patients in this arm during surgery~Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
253830|NCT01380080|E1|Reported Event|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
253831|NCT01379963|B1|Baseline|Methoxy-Polyethylene-Glycol-Epoetin Beta|Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
253832|NCT01379963|P1|Participant Flow|Methoxy-Polyethylene-Glycol-Epoetin Beta|Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta (Mircera, Continuous Erythropoietin Receptor Activator [C.E.R.A]) according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
253833|NCT01379963|O1|Outcome|Methoxy-Polyethylene-Glycol-Epoetin Beta|Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
253834|NCT01379963|O1|Outcome|Methoxy-Polyethylene-Glycol-Epoetin Beta|Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
253835|NCT01379963|E1|Reported Event|Methoxy-Polyethylene-Glycol-Epoetin Beta|Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
253836|NCT01379937|B5|Baseline|Total|Total of all reporting groups
253837|NCT01379937|B4|Baseline|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253838|NCT01379937|B3|Baseline|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253839|NCT01379937|B2|Baseline|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253840|NCT01379937|B1|Baseline|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253841|NCT01379937|P4|Participant Flow|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253842|NCT01379937|P3|Participant Flow|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253843|NCT01379937|P2|Participant Flow|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253844|NCT01379937|P1|Participant Flow|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253845|NCT01379937|O2|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253846|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253847|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253848|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253849|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253850|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253851|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253852|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253853|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253930|NCT01379781|E2|Reported Event|Treatment As Usual|Referred to Treatment in the Community.
253856|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253857|NCT01379937|O2|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253858|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253859|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253860|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253861|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253862|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region
253863|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253864|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253865|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253866|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253867|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253868|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253869|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253870|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253871|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253872|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253873|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253874|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253875|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253876|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253877|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253878|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253879|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253880|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
254110|NCT01379183|O1|Outcome|Erythromycin|"Erythromycin 200 mg i.v. suspension~Erythromycin: 200 mg suspension"
253881|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253882|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253883|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region
253884|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253885|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253886|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253887|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253888|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253889|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253890|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253891|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253892|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253893|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253894|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253895|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253896|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253897|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253898|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253899|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253900|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253901|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253902|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253903|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253904|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253905|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253994|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
253906|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253907|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253908|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253909|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253910|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253911|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253912|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253913|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253914|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253915|NCT01379937|O2|Outcome|GSK1562902A Formulation 2 - Havrix/Havrix Jr Pooled Group|Pooled group of subjects who received no or 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253916|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 & 2 - Havrix/Havrix Jr Pooled Group|Pooled group of subjects who received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, no or 1 booster dose of vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 or 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253917|NCT01379937|O2|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253918|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253919|NCT01379937|E4|Reported Event|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253920|NCT01379937|E3|Reported Event|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253921|NCT01379937|E2|Reported Event|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253922|NCT01379937|E1|Reported Event|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
253923|NCT01379781|B3|Baseline|Total|Total of all reporting groups
253924|NCT01379781|B2|Baseline|Treatment As Usual|"Referred to Treatment in the Community.~Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
253925|NCT01379781|B1|Baseline|Behavioral Intervention for PPD|"Behavioral Intervention for PPD delivered over 3 in-person sessions.~Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
253926|NCT01379781|P2|Participant Flow|Treatment As Usual|"Referred to Treatment in the Community.~Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
253927|NCT01379781|P1|Participant Flow|Behavioral Intervention for Postpartum Depression|"Behavioral Intervention for Postpartum Depression delivered over 3 in-person sessions.~Behavioral Intervention for Postpartum Depression: We will select a sample of pregnant women at risk for Postpartum Depression, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
253928|NCT01379781|O2|Outcome|Treatment As Usual|"Referred to Treatment in the Community.~Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
253929|NCT01379781|O1|Outcome|Behavioral Intervention for PPD|"Behavioral Intervention for PPD delivered over 3 in-person sessions.~Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
253931|NCT01379781|E1|Reported Event|Behavioral Intervention for PPD|"Behavioral Intervention for PPD delivered over 3 in-person sessions.~Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
253932|NCT01379768|B4|Baseline|Total|Total of all reporting groups
253933|NCT01379768|B3|Baseline|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
253934|NCT01379768|B2|Baseline|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
253935|NCT01379768|B1|Baseline|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
253936|NCT01379768|P3|Participant Flow|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
253937|NCT01379768|P2|Participant Flow|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
253938|NCT01379768|P1|Participant Flow|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
253939|NCT01379768|O3|Outcome|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
253940|NCT01379768|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
253941|NCT01379768|O1|Outcome|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
253942|NCT01379768|O3|Outcome|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
253943|NCT01379768|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
253944|NCT01379768|O1|Outcome|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
253945|NCT01379768|O3|Outcome|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
253946|NCT01379768|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
253947|NCT01379768|O1|Outcome|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
253948|NCT01379768|O3|Outcome|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
253949|NCT01379768|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
253950|NCT01379768|O1|Outcome|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
253951|NCT01379768|O3|Outcome|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
253952|NCT01379768|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
253953|NCT01379768|O1|Outcome|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
253954|NCT01379768|O3|Outcome|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
253955|NCT01379768|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
253956|NCT01379768|O1|Outcome|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
253957|NCT01379768|E3|Reported Event|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
254111|NCT01379183|O2|Outcome|Placebo|"Matching placebo i.v. suspension~Placebo: 200 mg suspension"
253958|NCT01379768|E2|Reported Event|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
253959|NCT01379768|E1|Reported Event|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
253960|NCT01379703|B1|Baseline|Total Study Population|HIV-1 infected participants who received lopinavir/ritonavir (any formulation) during any part of the study.
253961|NCT01379703|P3|Participant Flow|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
253962|NCT01379703|P2|Participant Flow|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
253963|NCT01379703|P1|Participant Flow|Tablets and Capsules or Oral Solution|HIV-1 infected participants who received both tablet and capsule formulations or oral solution.
253964|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
253965|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
253966|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
253967|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
253968|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
253969|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
253970|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
253971|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
253972|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
253973|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
253974|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
253975|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
253976|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
253977|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
253978|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
253979|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
253980|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
253981|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
253982|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
253983|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
253984|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
253985|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
253986|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
253987|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
253988|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
253989|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
253990|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
253991|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
253992|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
253993|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
253995|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
253996|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
253997|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
253998|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
253999|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
254000|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
254001|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
254002|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
254003|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
254004|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
254005|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
254006|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
254007|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
254008|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
254009|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
254010|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
254011|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
254012|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
254013|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
254014|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
254015|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
254016|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
254017|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
254018|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
254019|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
254020|NCT01379703|E3|Reported Event|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
254021|NCT01379703|E2|Reported Event|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
254022|NCT01379703|E1|Reported Event|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
254023|NCT01379664|B3|Baseline|Total|Total of all reporting groups
254024|NCT01379664|B2|Baseline|Sevoflurane|"Sevoflurane is to be administered to patients in this arm during surgery~Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
254025|NCT01379664|B1|Baseline|Isoflurane|"Isoflurane is to be administered to patients in this arm during surgery~Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
254026|NCT01379664|P2|Participant Flow|Sevoflurane|"Sevoflurane is to be administered to patients in this arm during surgery~Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
254027|NCT01379664|P1|Participant Flow|Isoflurane|"Isoflurane is to be administered to patients in this arm during surgery~Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
254028|NCT01379664|O2|Outcome|Sevoflurane|"Sevoflurane is to be administered to patients in this arm during surgery~Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
254112|NCT01379183|O1|Outcome|Erythromycin|"Erythromycin 200 mg i.v. suspension~Erythromycin: 200 mg suspension"
254113|NCT01379183|O2|Outcome|Placebo|"Matching placebo i.v. suspension~Placebo: 200 mg suspension"
254030|NCT01379664|O2|Outcome|Sevoflurane|"Sevoflurane is to be administered to patients in this arm during surgery~Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
254031|NCT01379664|O1|Outcome|Isoflurane|"Isoflurane is to be administered to patients in this arm during surgery~Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
254032|NCT01379664|O2|Outcome|Sevoflurane|"Sevoflurane is to be administered to patients in this arm during surgery~Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
254033|NCT01379664|O1|Outcome|Isoflurane|"Isoflurane is to be administered to patients in this arm during surgery~Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
254034|NCT01379664|E2|Reported Event|Sevoflurane|"Sevoflurane is to be administered to patients in this arm during surgery~Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
254035|NCT01379664|E1|Reported Event|Isoflurane|"Isoflurane is to be administered to patients in this arm during surgery~Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
254036|NCT01379651|B3|Baseline|Total|Total of all reporting groups
254037|NCT01379651|B2|Baseline|Control|controls were kept on an egg-free diet for 6 months
254038|NCT01379651|B1|Baseline|Specific Oral Tolerance Induction|Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
254039|NCT01379651|P2|Participant Flow|Control|controls were kept on an egg-free diet for 6 months
254040|NCT01379651|P1|Participant Flow|Specific Oral Tolerance Induction|Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
254041|NCT01379651|O2|Outcome|Control|controls were kept on an egg-free diet for 6 months
254042|NCT01379651|O1|Outcome|Specific Oral Tolerance Induction|Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
254043|NCT01379651|O2|Outcome|Control|controls were kept on an egg-free diet for 6 months
254044|NCT01379651|O1|Outcome|Specific Oral Tolerance Induction|Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
254045|NCT01379651|E2|Reported Event|Control|controls were kept on an egg-free diet for 6 months
254046|NCT01379651|E1|Reported Event|Specific Oral Tolerance Induction|Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
254047|NCT01379625|B3|Baseline|Total|Total of all reporting groups
254048|NCT01379625|B2|Baseline|Triheptanoin|"Subject randomized to consume 20% of energy from triheptanoin.~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
254049|NCT01379625|B1|Baseline|Medium Chain Triglyceride (MCT)|"Subjects randomized to consume 20% of energy from MCT~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
254050|NCT01379625|P2|Participant Flow|Triheptanoin|"Subject randomized to consume 20% of energy from triheptanoin.~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
254051|NCT01379625|P1|Participant Flow|Medium Chain Triglyceride (MCT)|"Subjects randomized to consume 20% of energy from MCT~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
254052|NCT01379625|O2|Outcome|Triheptanoin|"Subject randomized to consume 20% of energy from triheptanoin.~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
254053|NCT01379625|O1|Outcome|Medium Chain Triglyceride (MCT)|"Subjects randomized to consume 20% of energy from MCT~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
254054|NCT01379625|O2|Outcome|Triheptanoin|"Subject randomized to consume 20% of energy from triheptanoin.~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
254055|NCT01379625|O1|Outcome|Medium Chain Triglyceride (MCT)|"Subjects randomized to consume 20% of energy from MCT~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
254056|NCT01379625|O2|Outcome|Triheptanoin|"Subject randomized to consume 20% of energy from triheptanoin.~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
254057|NCT01379625|O1|Outcome|Medium Chain Triglyceride (MCT)|"Subjects randomized to consume 20% of energy from MCT~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
254058|NCT01379625|E2|Reported Event|Triheptanoin|"Subject randomized to consume 20% of energy from triheptanoin.~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
254059|NCT01379625|E1|Reported Event|Medium Chain Triglyceride (MCT)|"Subjects randomized to consume 20% of energy from MCT~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
254060|NCT01379534|B3|Baseline|Total|Total of all reporting groups
254061|NCT01379534|B2|Baseline|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
254062|NCT01379534|B1|Baseline|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
254063|NCT01379534|P2|Participant Flow|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
254064|NCT01379534|P1|Participant Flow|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
254065|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
254114|NCT01379183|O1|Outcome|Erythromycin|"Erythromycin 200 mg i.v. suspension~Erythromycin: 200 mg suspension"
254066|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
254067|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
254068|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
254069|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
254070|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
254071|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
254072|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
254073|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
254074|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
254075|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
254076|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
254077|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
254078|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
254079|NCT01379534|E2|Reported Event|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
254080|NCT01379534|E1|Reported Event|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
254081|NCT01379521|B3|Baseline|Total|Total of all reporting groups
254082|NCT01379521|B2|Baseline|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
254083|NCT01379521|B1|Baseline|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
254084|NCT01379521|P2|Participant Flow|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
254085|NCT01379521|P1|Participant Flow|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
254086|NCT01379521|O2|Outcome|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
254087|NCT01379521|O1|Outcome|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
254088|NCT01379521|O2|Outcome|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
254089|NCT01379521|O1|Outcome|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
254090|NCT01379521|O2|Outcome|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
254091|NCT01379521|O1|Outcome|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
254092|NCT01379521|O2|Outcome|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
254093|NCT01379521|O1|Outcome|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
254094|NCT01379521|O2|Outcome|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
254095|NCT01379521|O1|Outcome|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
254096|NCT01379521|O2|Outcome|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
254097|NCT01379521|O1|Outcome|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
254098|NCT01379521|O2|Outcome|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
254099|NCT01379521|O1|Outcome|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
254100|NCT01379521|E2|Reported Event|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
254101|NCT01379521|E1|Reported Event|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
254102|NCT01379183|B3|Baseline|Total|Total of all reporting groups
254103|NCT01379183|B2|Baseline|Placebo|Matching placebo i.v. suspension
254104|NCT01379183|B1|Baseline|Erythromycin|Erythromycin 200 mg i.v. suspension
254105|NCT01379183|P2|Participant Flow|Placebo|Matching placebo i.v. suspension
254106|NCT01379183|P1|Participant Flow|Erythromycin|Erythromycin 200 mg i.v. suspension
254107|NCT01379183|O2|Outcome|Placebo|"Matching placebo i.v. suspension~Placebo: 200 mg suspension"
254108|NCT01379183|O1|Outcome|Erythromycin|"Erythromycin 200 mg i.v. suspension~Erythromycin: 200 mg suspension"
254109|NCT01379183|O2|Outcome|Placebo|"Matching placebo i.v. suspension~Placebo: 200 mg suspension"
254115|NCT01379183|O2|Outcome|Placebo|"Matching placebo i.v. suspension~Placebo: 200 mg suspension"
254126|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
254127|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
254128|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
254129|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
254130|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
254131|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
254132|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
254133|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
254134|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
254135|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
254136|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
254137|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
254138|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
254139|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
254140|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
254141|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
254142|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
254143|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
254144|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
254145|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
254146|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
254147|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
254148|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
254149|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
254150|NCT01378988|E2|Reported Event|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance dose
254151|NCT01378988|E1|Reported Event|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance dose
254152|NCT01378975|B3|Baseline|Total|Total of all reporting groups
254153|NCT01378975|B2|Baseline|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254154|NCT01378975|B1|Baseline|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254155|NCT01378975|P2|Participant Flow|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254156|NCT01378975|P1|Participant Flow|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254157|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254158|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254187|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
254159|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254160|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254161|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254162|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254163|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254164|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254165|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254166|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254167|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254168|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254169|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254170|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254188|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
254171|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254172|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254173|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254174|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254175|NCT01378975|O1|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254176|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254177|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254178|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254179|NCT01378975|E2|Reported Event|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254180|NCT01378975|E1|Reported Event|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
254181|NCT01378962|B1|Baseline|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
254182|NCT01378962|P1|Participant Flow|Erlotinib 150 mg|Erlotinib 150 milligrams (mg) tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
254183|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
254184|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
254185|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
254186|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
255149|NCT01375751|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
254189|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
254190|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
254191|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
254192|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
254193|NCT01378962|E1|Reported Event|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
254194|NCT01378520|B1|Baseline|Entire Study Population|Includes groups randomized to receive Ketoconazole first and inert powder first.
254195|NCT01378520|P2|Participant Flow|First Inert Powder, Then Ketoconazole|Inert powder (in capsule taken orally) in first intervention period and Ketoconzaole (600 mg taken orally) in second intervention period.
254196|NCT01378520|P1|Participant Flow|First Ketoconazole, Then Inert Powder|Ketoconzaole (600 mg taken orally) in first intervention period and inert powder (in capsule taken orally) in second intervention period.
254197|NCT01378520|O2|Outcome|Inert Powder|Inert powder (in capsule taken orally)
254198|NCT01378520|O1|Outcome|Ketoconazole|Ketoconazole (600 mg given orally)
254199|NCT01378520|O2|Outcome|Inert Powder|Inert powder (in capsule taken orally)
254200|NCT01378520|O1|Outcome|Ketoconazole|Ketoconazole (600 mg given orally)
254201|NCT01378520|O2|Outcome|Inert Powder|Inert powder (in capsule taken orally)
254202|NCT01378520|O1|Outcome|Ketoconazole|Ketoconazole (600 mg given orally)
254203|NCT01378520|E2|Reported Event|Inert Powder|Inert powder (in capsule taken orally)
254204|NCT01378520|E1|Reported Event|Ketoconazole|Ketoconazole(600 mg taken orally)
254205|NCT01378429|B3|Baseline|Total|Total of all reporting groups
254206|NCT01378429|B2|Baseline|Ciclesonide Nasal Aerosol (74 mcg)|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
254207|NCT01378429|B1|Baseline|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
254208|NCT01378429|P2|Participant Flow|Ciclesonide Nasal Aerosol|"ciclesonide nasal aerosol (74 mcg)~ciclesonide nasal aerosol: ciclesonide nasal aerosol (74 mcg)"
254209|NCT01378429|P1|Participant Flow|Placebo|Placebo: Placebo
254210|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
254211|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
254212|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril) for 6 weeks
254213|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril) for 6 weeks
254214|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
254215|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
254216|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
254217|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
254218|NCT01378429|O1|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
254219|NCT01378429|O1|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
254220|NCT01378429|O1|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
254221|NCT01378429|O1|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
254222|NCT01378429|O1|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
254223|NCT01378429|O1|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
254224|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril) for 6 weeks
254225|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril) for 6 weeks
254226|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
254227|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
254228|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
254229|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
254230|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
254231|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
254232|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril) for 6 weeks
254233|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril) for 6 weeks
254234|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
254235|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
254236|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
254237|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
269070|NCT01333397|O3|Outcome|Dysport NG 50 U|
254238|NCT01378429|E2|Reported Event|Ciclesonide Nasal Aerosol|"ciclesonide nasal aerosol (74 mcg)~ciclesonide nasal aerosol: ciclesonide nasal aerosol (74 mcg)"
254239|NCT01378429|E1|Reported Event|Placebo|Placebo: Placebo
254240|NCT01378416|B1|Baseline|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
254241|NCT01378416|P1|Participant Flow|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
254242|NCT01378416|O1|Outcome|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
254243|NCT01378416|O1|Outcome|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
254244|NCT01378416|O1|Outcome|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
254245|NCT01378416|O1|Outcome|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
254246|NCT01378416|O1|Outcome|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
254247|NCT01378416|E1|Reported Event|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
254248|NCT01378325|B3|Baseline|Total|Total of all reporting groups
254249|NCT01378325|B2|Baseline|Phenylephrine|PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery
254250|NCT01378325|B1|Baseline|Saline|Prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
254251|NCT01378325|P2|Participant Flow|Saline|crystalloid coload with lactated Ringer solution combined with prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
254252|NCT01378325|P1|Participant Flow|Phenylephrine|"PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery~Phenylephrine: Prophylactic variable rate of phenylephrine infusion started at 0.75 µg/kg/min vs saline"
254253|NCT01378325|O2|Outcome|Saline|crystalloid coload with lactated Ringer solution combined with prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
254254|NCT01378325|O1|Outcome|Phenylephrine|"PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery~Phenylephrine: Prophylactic variable rate of phenylephrine infusion started at 0.75 µg/kg/min vs saline"
254255|NCT01378325|E2|Reported Event|Phenylephrine|Phenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery
254256|NCT01378325|E1|Reported Event|Saline|Prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
254257|NCT01378221|B3|Baseline|Total|Total of all reporting groups
254258|NCT01378221|B2|Baseline|Group 2|cardiac surgery patients aged 75 years and over
254259|NCT01378221|B1|Baseline|Group 1|cardiac surgery patients age 65 years and less
254260|NCT01378221|P2|Participant Flow|Group 2|cardiac surgery patients aged 75 years and over
254261|NCT01378221|P1|Participant Flow|Group 1|cardiac surgery patients age 65 years and less
254262|NCT01378221|O2|Outcome|Group 2|cardiac surgery patients aged 75 years and over
254263|NCT01378221|O1|Outcome|Group 1|cardiac surgery patients age 65 years and less
254264|NCT01378221|E2|Reported Event|Group 2|cardiac surgery patients aged 75 years and over
254265|NCT01378221|E1|Reported Event|Group 1|cardiac surgery patients age 65 years and less
254266|NCT01378195|B3|Baseline|Total|Total of all reporting groups
254267|NCT01378195|B2|Baseline|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
254268|NCT01378195|B1|Baseline|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
254269|NCT01378195|P2|Participant Flow|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
254270|NCT01378195|P1|Participant Flow|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
254271|NCT01378195|O2|Outcome|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
254272|NCT01378195|O1|Outcome|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
254273|NCT01378195|O2|Outcome|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
254274|NCT01378195|O1|Outcome|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
254275|NCT01378195|O2|Outcome|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
254276|NCT01378195|O1|Outcome|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
254277|NCT01378195|E2|Reported Event|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
254278|NCT01378195|E1|Reported Event|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
254279|NCT01378117|B4|Baseline|Total|Total of all reporting groups
254280|NCT01378117|B3|Baseline|Glargine and Lispro + SSI|Glargine once daily and lispro before meals + acqhs supplemental insulin lispro as needed for elevated blod glucose
254281|NCT01378117|B2|Baseline|Sitagliptin and Glargine+ SSI|Sitagliptin 50-100mg po once a day and SQ glargine insulin once daily + acqhs correctional doses of lispro if needed for elevated blood glucose
254282|NCT01378117|B1|Baseline|Sitagliptin + SSI Prn|Sitagliptin once daily plus supplemental doses of lispro if needed.
254283|NCT01378117|P3|Participant Flow|Glargine and Lispro + SSI|Glargine once daily and lispro before meals + acqhs supplemental insulin lispro as needed for elevated blod glucose
254284|NCT01378117|P2|Participant Flow|Sitagliptin and Glargine+ SSI|Sitagliptin 50-100mg po once a day and SQ glargine insulin once daily + acqhs correctional doses of lispro if needed for elevated blood glucose
254285|NCT01378117|P1|Participant Flow|Sitagliptin + SSI Prn|Sitagliptin once daily plus supplemental doses of lispro if needed.
254286|NCT01378117|O3|Outcome|Glargine and Lispro + SSI|Glargine once daily and lispro before meals + acqhs supplemental insulin lispro as needed for elevated blod glucose
254287|NCT01378117|O2|Outcome|Sitagliptin and Glargine+ SSI|Sitagliptin 50-100mg po once a day and SQ glargine insulin once daily + acqhs correctional doses of lispro if needed for elevated blood glucose
254288|NCT01378117|O1|Outcome|Sitagliptin + SSI Prn|Sitagliptin once daily plus supplemental doses of lispro if needed.
254289|NCT01378117|E3|Reported Event|Glargine and Lispro + SSI|Glargine once daily and lispro before meals + acqhs supplemental insulin lispro as needed for elevated blod glucose
254290|NCT01378117|E2|Reported Event|Sitagliptin and Glargine+ SSI|Sitagliptin 50-100mg po once a day and SQ glargine insulin once daily + acqhs correctional doses of lispro if needed for elevated blood glucose
254291|NCT01378117|E1|Reported Event|Sitagliptin + SSI Prn|Sitagliptin once daily plus supplemental doses of lispro if needed.
254292|NCT01378104|B3|Baseline|Total|Total of all reporting groups
254293|NCT01378104|B2|Baseline|80% Dosage Group of Peginterferon Alfa 2a|"This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.~peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable"
254294|NCT01378104|B1|Baseline|100% Dosage Group of Peginterferon Alfa 2a|"These group patients would be treated with standard dose 180 ug/week for 48 weeks.~peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.~In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose."
254295|NCT01378104|P2|Participant Flow|80% Dosage Group of Peginterferon Alfa 2a|"This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.~peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable"
254296|NCT01378104|P1|Participant Flow|100% Dosage Group of Peginterferon Alfa 2a|"These group patients would be treated with standard dose 180 ug/week for 48 weeks.~peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.~In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose."
254297|NCT01378104|O2|Outcome|The Patients With Unfavourable IL28B Genotype|These group patients show the IL28B rs12979860 CT or TT and rs8099917 TG or GG.
254298|NCT01378104|O1|Outcome|Favourable IL28B Genotype|These group patients show the IL28B rs12979860CC and rs8099917TT.
254299|NCT01378104|O2|Outcome|80% Dosage Group of Peginterferon Alfa 2a|"This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.~peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable"
254300|NCT01378104|O1|Outcome|100% Dosage Group of Peginterferon Alfa 2a|"These group patients would be treated with standard dose 180 ug/week for 48 weeks.~peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.~In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose."
254301|NCT01378104|E2|Reported Event|80% Dosage Group of Peginterferon Alfa 2a|"This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.~peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable"
254302|NCT01378104|E1|Reported Event|100% Dosage Group of Peginterferon Alfa 2a|"These group patients would be treated with standard dose 180 ug/week for 48 weeks.~peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.~In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose."
254303|NCT01378065|B1|Baseline|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254304|NCT01378065|P1|Participant Flow|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254305|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254306|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254307|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254308|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
255683|NCT01373450|O2|Outcome|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
254309|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254310|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254311|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254312|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254313|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254314|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254315|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254316|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254317|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254318|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254319|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254320|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254321|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254322|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254323|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254324|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254325|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254326|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254327|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254328|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254329|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254330|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254331|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254332|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254333|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254334|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254335|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254336|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254337|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
255684|NCT01373450|O1|Outcome|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
254338|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254339|NCT01378065|E1|Reported Event|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
254340|NCT01377922|B3|Baseline|Total|Total of all reporting groups
254341|NCT01377922|B2|Baseline|Part 2 and Part 3 Amifampridine Phosphate|"Matching amifampridine phosphate tablets, 10 mg, administered 3-4 times a day for 2 weeks.~Amifampridine Phosphate: 30-80 mg given 3-4 times per day with a maximum single dose of 20 mg (2 x 10 mg tablets)."
254342|NCT01377922|B1|Baseline|Part 2 and Part 3 Placebo|"Matching placebo tablets, administered 3-4 times a day for 2 weeks.~Placebo tablets indistinguishable from amifampridine phosphate tablets. The placebo was administered consistent with the dose and dose regimen of amifampridine phosphate."
254343|NCT01377922|P2|Participant Flow|Part 2 and Part 3 Amifampridine Phosphate|"Matching amifampridine phosphate tablets, 10 mg, administered 3-4 times a day for 2 weeks.~Amifampridine Phosphate: 30-80 mg given 3-4 times per day with a maximum single dose of 20 mg (2 x 10 mg tablets)."
254344|NCT01377922|P1|Participant Flow|Part 2 and Part 3 Placebo|"Matching placebo tablets, administered 3-4 times a day for 2 weeks.~Placebo tablets indistinguishable from amifampridine phosphate tablets. The placebo was administered consistent with the dose and dose regimen of amifampridine phosphate."
254345|NCT01377922|O2|Outcome|Amifampridine Phosphate|"Matching amifampridine phosphate tablets, 10 mg, administered 3-4 times a day for 2 weeks.~Amifampridine Phosphate: 30-80 mg given 3-4 times per day with a maximum single dose of 20 mg (2 x 10 mg tablets)."
254346|NCT01377922|O1|Outcome|Placebo|"Matching placebo tablets administered 3-4 times a day over 2 weeks.~Placebo: Matching number of tablets to the individual patient's tablet count of active at baseline."
254347|NCT01377922|O2|Outcome|Amifampridine Phosphate|"Matching amifampridine phosphate tablets, 10 mg, administered 3-4 times a day for 2 weeks.~Amifampridine Phosphate: 30-80 mg given 3-4 times per day with a maximum single dose of 20 mg (2 x 10 mg tablets)."
254348|NCT01377922|O1|Outcome|Placebo|"Matching placebo tablets administered 3-4 times a day over 2 weeks.~Placebo: Matching number of tablets to the individual patient's tablet count of active at baseline."
254349|NCT01377922|O2|Outcome|Amifampridine Phosphate|"Matching amifampridine phosphate tablets, 10 mg, administered 3-4 times a day for 2 weeks.~Amifampridine Phosphate: 30-80 mg given 3-4 times per day with a maximum single dose of 20 mg (2 x 10 mg tablets)."
254350|NCT01377922|O1|Outcome|Placebo|"Matching placebo tablets administered 3-4 times a day over 2 weeks.~Placebo: Matching number of tablets to the individual patient's tablet count of active at baseline."
254351|NCT01377922|O2|Outcome|Amifampridine Phosphate|"Matching amifampridine phosphate tablets, 10 mg, administered 3-4 times a day for 2 weeks.~Amifampridine Phosphate: 30-80 mg given 3-4 times per day with a maximum single dose of 20 mg (2 x 10 mg tablets)."
254352|NCT01377922|O1|Outcome|Placebo|"Matching placebo tablets administered 3-4 times a day over 2 weeks.~Placebo: Matching number of tablets to the individual patient's tablet count of active at baseline."
254353|NCT01377922|E2|Reported Event|Part 2 and Part 3 Amifampridine Phosphate|"Matching amifampridine phosphate tablets, 10 mg, administered 3-4 times a day for 2 weeks.~Amifampridine Phosphate: 30-80 mg given 3-4 times per day with a maximum single dose of 20 mg (2 x 10 mg tablets)."
254354|NCT01377922|E1|Reported Event|Part 2 and Part 3 Placebo|"Matching placebo tablets, administered 3-4 times a day for 2 weeks.~Placebo tablets indistinguishable from amifampridine phosphate tablets. The placebo was administered consistent with the dose and dose regimen of amifampridine phosphate."
254355|NCT01377636|B1|Baseline|Pre and Post Isoproterenol Infusion|Subjects undergoing catheter ablation for atrial fibrillation had measurements pre and post isoproterenol infusion
254356|NCT01377636|P1|Participant Flow|Pre and Post Isoproterenol Infusion|Bispectral EEG (BIS) monitoring and neurological examinations were repeated throughout an isoproterenol infusion protocol (20 minutes maximum) to measure the changes in arousal and ability to follow commands under anesthesia
254357|NCT01377636|O1|Outcome|Pre and Post Isoproterenol Infusion|Subjects undergoing catheter ablation for atrial fibrillation had measurements pre and post isoproterenol infusion
254358|NCT01377636|O1|Outcome|Pre and Post Isoproterenol Infusion|Subjects undergoing catheter ablation for atrial fibrillation had measurements pre and post isoproterenol infusion
254359|NCT01377636|O1|Outcome|Pre and Post Isoproterenol Infusion|Subjects undergoing catheter ablation for atrial fibrillation had measurements pre and post isoproterenol infusion
254360|NCT01377636|O1|Outcome|Isoproterenol, BIS, Forearm Test|"30 consecutive patients scheduled for EP studies under general anesthesia will participate in the study. Patients with neuromuscular disease precluding the use of succinylcholine will be excluded. The only other exclusions will be patient or cardiologist refusal. No attempts will be made to alter concurrent patient medication.~Isoproterenol: patients will receive isoproterenol, have a BIS monitoring device and a modified isolated forearm test (no neuromuscular blockade)."
254361|NCT01377636|O1|Outcome|Pre and Post Isoproterenol Infusion|Subjects undergoing catheter ablation for atrial fibrillation had measurements pre and post isoproterenol infusion
254362|NCT01377636|O1|Outcome|Pre and Post Isoproterenol Infusion|Subjects undergoing catheter ablation for atrial fibrillation had measurements pre and post isoproterenol infusion
254363|NCT01377636|O1|Outcome|Isoproterenol, BIS, Forearm Test|"30 consecutive patients scheduled for EP studies under general anesthesia will participate in the study. Patients with neuromuscular disease precluding the use of succinylcholine will be excluded. The only other exclusions will be patient or cardiologist refusal. No attempts will be made to alter concurrent patient medication.~Isoproterenol: patients will receive isoproterenol, have a BIS monitoring device and a modified isolated forearm test (no neuromuscular blockade)."
254364|NCT01377636|O1|Outcome|Isoproterenol, BIS, Forearm Test|"30 consecutive patients scheduled for EP studies under general anesthesia will participate in the study. Patients with neuromuscular disease precluding the use of succinylcholine will be excluded. The only other exclusions will be patient or cardiologist refusal. No attempts will be made to alter concurrent patient medication.~Isoproterenol: patients will receive isoproterenol, have a BIS monitoring device and a modified isolated forearm test (no neuromuscular blockade)."
261070|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
254365|NCT01377636|O1|Outcome|Pre and Post Isoproterenol Infusion|BIS monitoring and neurological examinations were repeated throughout an isoproterenol infusion protocol (20 minutes maximum) to measure the changes in arousal and ability to follow commands under anesthesia
254366|NCT01377636|E1|Reported Event|Pre and Post Isoproterenol Infusion|In this study, serious adverse events were considered clinically significant adverse events. The well known isoproterenol effects on heart rate, rhythm, ST segments, and blood pressure were noted.
254367|NCT01377623|B3|Baseline|Total|Total of all reporting groups
254368|NCT01377623|B2|Baseline|Dexmedetomidine Group|Fifty six subjects (28 in each arm) will be enrolled. Subjects undergoing one or two level spinal fusion surgery will be screened for eligibility to participate in the study. Subject will be screened, recruited and randomized during the preadmission visit or the day of surgery. Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
254369|NCT01377623|B1|Baseline|Placebo Group|Subjects undergoing one or two level spinal fusion surgery will be screened for eligibility to participate in the study. Subject will be screened, recruited and randomized during the preadmission visit or the day of surgery. Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
254370|NCT01377623|P2|Participant Flow|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
254371|NCT01377623|P1|Participant Flow|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
254372|NCT01377623|O2|Outcome|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
254373|NCT01377623|O1|Outcome|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
254374|NCT01377623|O2|Outcome|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
254375|NCT01377623|O1|Outcome|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
254376|NCT01377623|O2|Outcome|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
254377|NCT01377623|O1|Outcome|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
254378|NCT01377623|O2|Outcome|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
254379|NCT01377623|O1|Outcome|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
254380|NCT01377623|O2|Outcome|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
254381|NCT01377623|O1|Outcome|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
254382|NCT01377623|E2|Reported Event|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
254383|NCT01377623|E1|Reported Event|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
254384|NCT01377584|B7|Baseline|Total|Total of all reporting groups
254385|NCT01377584|B6|Baseline|Partners in Usual Care|Partners will not attend any intervention sessions
254386|NCT01377584|B5|Baseline|Patients in Usual Care|Patients will not attend any intervention sessions.
254387|NCT01377584|B4|Baseline|Partners in the Patient-oriented Intervention|Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions.
254388|NCT01377584|B3|Baseline|Patients in the Patient-oriented Intervention|"Patients randomly assigned to the patient-oriented (PT) group will attend two face to face sessions and participate in a telephone follow-up session.~Patient-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the patient with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the patient with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use."
254389|NCT01377584|B2|Baseline|Partners in the Couple-oriented Intervention|Partners randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with the patient and participate in an individual telephone follow-up session.
254390|NCT01377584|B1|Baseline|Patients in the Couple-oriented Intervention|"Patients randomly assigned to the couple-oriented (CO) group will attend two face to face sessions and participate in an individual telephone follow-up session.~Couple-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the couple with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the couple with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The individual telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use."
254391|NCT01377584|P6|Participant Flow|Partners in Usual Care|Partners will not attend any intervention sessions.
254392|NCT01377584|P5|Participant Flow|Patients in Usual Care|Patients will not attend any intervention sessions.
254393|NCT01377584|P4|Participant Flow|Partners in the Patient-oriented Intervention|Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions.
254394|NCT01377584|P3|Participant Flow|Patients in the Patient-oriented Intervention|"Patients randomly assigned to the patient-oriented (PT) group will attend two face to face sessions and participate in a telephone follow-up session.~Patient-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the patient with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the patient with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use."
254395|NCT01377584|P2|Participant Flow|Partners in the Couple-oriented Intervention|Partners randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with the patient and participate in an individual telephone follow-up session.
254396|NCT01377584|P1|Participant Flow|Patients in the Couple-oriented Intervention|"Patients randomly assigned to the couple-oriented (CO) group will attend two face to face sessions and participate in an individual telephone follow-up session.~Couple-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the couple with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the couple with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The individual telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use."
254397|NCT01377584|O3|Outcome|Patients in Usual Care|Patients will not attend any intervention sessions.
254398|NCT01377584|O2|Outcome|Patients in the Patient-oriented Intervention|"Patients randomly assigned to the patient-oriented (PT) group will attend two face to face sessions and participate in a telephone follow-up session.~Patient-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the patient with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the patient with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use."
254399|NCT01377584|O1|Outcome|Patients in the Couple-oriented Intervention|"Patients randomly assigned to the couple-oriented (CO) group will attend two face to face sessions and participate in an individual telephone follow-up session.~Couple-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the couple with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the couple with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The individual telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use."
254400|NCT01377584|O6|Outcome|Partners in Usual Care|Partners will not attend any intervention sessions.
254401|NCT01377584|O5|Outcome|Patients in Usual Care|Patients will not attend any intervention sessions.
254402|NCT01377584|O4|Outcome|Partners in the Patient-oriented Intervention|Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions.
254403|NCT01377584|O3|Outcome|Patients in the Patient-oriented Intervention|"Patients randomly assigned to the patient-oriented (PT) group will attend two face to face sessions and participate in a telephone follow-up session.~Patient-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the patient with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the patient with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use."
254404|NCT01377584|O2|Outcome|Partners in the Couple-oriented Intervention|Partners randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with the patient and participate in an individual telephone follow-up session
254405|NCT01377584|O1|Outcome|Patients in the Couple-oriented Intervention|"Patients randomly assigned to the couple-oriented (CO) group will attend two face to face sessions and participate in an individual telephone follow-up session.~Couple-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the couple with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the couple with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The individual telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use."
254406|NCT01377584|O6|Outcome|Partners in Usual Care|Partners will not attend any intervention sessions.
254407|NCT01377584|O5|Outcome|Patients in Usual Care|Patients will not attend any intervention sessions.
254408|NCT01377584|O4|Outcome|Partners in the Patient-oriented Intervention|Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions.
254409|NCT01377584|O3|Outcome|Patients in the Patient-oriented Intervention|"Patients randomly assigned to the patient-oriented (PT) group will attend two face to face sessions and participate in a telephone follow-up session.~Patient-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the patient with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the patient with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use."
255685|NCT01373450|O2|Outcome|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
254410|NCT01377584|O2|Outcome|Partners in the Couple-oriented Intervention|Partners randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with the patient and participate in an individual telephone follow-up session
254411|NCT01377584|O1|Outcome|Patients in the Couple-oriented Intervention|"Patients randomly assigned to the couple-oriented (CO) group will attend two face to face sessions and participate in an individual telephone follow-up session.~Couple-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the couple with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the couple with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The individual telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use."
254412|NCT01377584|O6|Outcome|Partners in Usual Care|Partners will not attend any intervention sessions.
254413|NCT01377584|O5|Outcome|Patients in Usual Care|Patients will not attend any intervention sessions.
254414|NCT01377584|O4|Outcome|Partners in the Patient-oriented Intervention|Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions.
254415|NCT01377584|O3|Outcome|Patients in the Patient-oriented Intervention|"Patients randomly assigned to the patient-oriented (PT) group will attend two face to face sessions and participate in a telephone follow-up session.~Patient-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the patient with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the patient with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use."
254416|NCT01377584|O2|Outcome|Partners in the Couple-oriented Intervention|Partners randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with the patient and participate in an individual telephone follow-up session.
254417|NCT01377584|O1|Outcome|Patients in the Couple-oriented Intervention|"Patients randomly assigned to the couple-oriented (CO) group will attend two face to face sessions and participate in an individual telephone follow-up session.~Couple-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the couple with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the couple with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The individual telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use."
254418|NCT01377584|E6|Reported Event|Partners in Usual Care|Partners will not attend any intervention sessions.
254419|NCT01377584|E5|Reported Event|Patients in Usual Care|Patients will not attend any intervention sessions.
254420|NCT01377584|E4|Reported Event|Partners in the Patient-oriented Intervention|Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions.
254421|NCT01377584|E3|Reported Event|Patients in the Patient-oriented Intervention|"Patients randomly assigned to the patient-oriented (PT) group will attend two face to face sessions and participate in a telephone follow-up session.~Patient-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the patient with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the patient with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use."
254422|NCT01377584|E2|Reported Event|Partners in the Couple-oriented Intervention|Partners randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with the patient and participate in an individual telephone follow-up session
254423|NCT01377584|E1|Reported Event|Patients in the Couple-oriented Intervention|"Patients randomly assigned to the couple-oriented (CO) group will attend two face to face sessions and participate in an individual telephone follow-up session.~Couple-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the couple with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the couple with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The individual telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use."
254424|NCT01377480|B5|Baseline|Total|Total of all reporting groups
254425|NCT01377480|B4|Baseline|Benznidazole + Placebo|BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days
254426|NCT01377480|B3|Baseline|Posaconazole + Benznidazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days and BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
254427|NCT01377480|B2|Baseline|Placebo|POS placebo (10 mL) oral suspension twice daily for 60 days
254428|NCT01377480|B1|Baseline|Posaconazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days
254429|NCT01377480|P4|Participant Flow|Benznidazole + Placebo|BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days
254430|NCT01377480|P3|Participant Flow|Posaconazole + Benznidazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days and BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
254431|NCT01377480|P2|Participant Flow|Placebo|POS placebo (10 mL) oral suspension twice daily for 60 days
254432|NCT01377480|P1|Participant Flow|Posaconazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days
254433|NCT01377480|O4|Outcome|Benznidazole + Placebo|BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days
254434|NCT01377480|O3|Outcome|Posaconazole + Benznidazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days and BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
254435|NCT01377480|O2|Outcome|Placebo|POS placebo (10 mL) oral suspension twice daily for 60 days
254436|NCT01377480|O1|Outcome|Posaconazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days
254437|NCT01377480|E4|Reported Event|Benznidazole + Placebo|BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days
254438|NCT01377480|E3|Reported Event|Posaconazole + Benznidazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days and BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
254439|NCT01377480|E2|Reported Event|Placebo|POS placebo (10 mL) oral suspension twice daily for 60 days
254440|NCT01377480|E1|Reported Event|Posaconazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days
254441|NCT01377467|B3|Baseline|Total|Total of all reporting groups
254442|NCT01377467|B2|Baseline|Control|No treatment
254443|NCT01377467|B1|Baseline|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
254444|NCT01377467|P2|Participant Flow|Control|No treatment
254445|NCT01377467|P1|Participant Flow|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
254446|NCT01377467|O2|Outcome|Control|No treatment
254447|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
254448|NCT01377467|O2|Outcome|Control|No treatment
254449|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
254450|NCT01377467|O2|Outcome|Control|No treatment
254451|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
254452|NCT01377467|O2|Outcome|Control|No treatment
254453|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
254454|NCT01377467|O2|Outcome|Control|No treatment
254455|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
254456|NCT01377467|O2|Outcome|Control|No treatment
254457|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
254458|NCT01377467|O2|Outcome|Control|No treatment
254459|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
254460|NCT01377467|O2|Outcome|Control|No treatment
254461|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
254462|NCT01377467|O2|Outcome|Control|No treatment
254463|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
254464|NCT01377467|O2|Outcome|Control|No treatment
254465|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
254466|NCT01377467|O2|Outcome|Control|No treatment
254467|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
254468|NCT01377467|O2|Outcome|Control|No treatment
254469|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
254470|NCT01377467|O2|Outcome|Control|No treatment
254471|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
254472|NCT01377467|O2|Outcome|Control|No treatment
254473|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
254474|NCT01377467|O2|Outcome|Control|No treatment
254475|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
254476|NCT01377467|O2|Outcome|Control|No treatment
254477|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
254478|NCT01377467|O2|Outcome|Control|No treatment
254479|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
254480|NCT01377467|O2|Outcome|Control|No treatment
254481|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
254482|NCT01377467|O2|Outcome|Control|No treatment
254483|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
254484|NCT01377467|O2|Outcome|Control|No treatment
254485|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
254486|NCT01377467|O2|Outcome|Control|No treatment
254487|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
254488|NCT01377467|E2|Reported Event|Control|No treatment
254489|NCT01377467|E1|Reported Event|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
254490|NCT01377441|B3|Baseline|Total|Total of all reporting groups
254491|NCT01377441|B2|Baseline|Placebo/Saline Solution|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo~Placebo/Saline solution: Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose."
254492|NCT01377441|B1|Baseline|Ibuprofen|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo.~Ibuprofen: Patients will receive either 800mg IV ibuprofen or placebo pre-operatively.~Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose."
254493|NCT01377441|P2|Participant Flow|Placebo/Saline Solution|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo~Placebo/Saline solution: Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose."
254494|NCT01377441|P1|Participant Flow|Ibuprofen|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo.~Ibuprofen: Patients will receive either 800mg IV ibuprofen or placebo pre-operatively.~Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose."
254495|NCT01377441|O2|Outcome|Placebo/Saline Solution|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo~Placebo/Saline solution: Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose."
254496|NCT01377441|O1|Outcome|Ibuprofen|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo.~Ibuprofen: Patients will receive either 800mg IV ibuprofen or placebo pre-operatively.~Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose."
254497|NCT01377441|O2|Outcome|Placebo/Saline Solution|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo~Placebo/Saline solution: Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose."
254498|NCT01377441|O1|Outcome|Ibuprofen|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo.~Ibuprofen: Patients will receive either 800mg IV ibuprofen or placebo pre-operatively.~Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose."
254499|NCT01377441|E2|Reported Event|Placebo/Saline Solution|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo~Placebo/Saline solution: Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose."
254500|NCT01377441|E1|Reported Event|Ibuprofen|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo.~Ibuprofen: Patients will receive either 800mg IV ibuprofen or placebo pre-operatively.~Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose."
254501|NCT01377402|B1|Baseline|Patients With Suspected Acute Coronary Chest Pain|Patients recruited immediately following acute hospital admission for suspected coronary chest pain.
254502|NCT01377402|P1|Participant Flow|Patients With Suspected Acute Coronary Chest Pain|Men and women admitted with chest pain and suspected acute coronary syndrome (ACS).
254503|NCT01377402|O2|Outcome|Myocardial Re-infarction|Patients with one or more myocardial re-infarctions during the course of the study
254504|NCT01377402|O1|Outcome|Cardiovascular Death|Patients with confirmed cardiovascular death during the course of the study
254505|NCT01377402|O1|Outcome|Patients With Suspected ACS|Patients with acute hospitalisation due to suspected coronary chest pain.
254506|NCT01377402|E1|Reported Event|Patients With Suspected ACS|Patients admitted to hospital with acute chest pain.
254507|NCT01377233|B6|Baseline|Total|Total of all reporting groups
254508|NCT01377233|B5|Baseline|Zicronapine 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
254509|NCT01377233|B4|Baseline|Zicronapine 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
254510|NCT01377233|B3|Baseline|Zicronapine 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
254511|NCT01377233|B2|Baseline|Zicronapine 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
254512|NCT01377233|B1|Baseline|Zicronapine Open-label 10 mg Daily|Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label
254513|NCT01377233|P5|Participant Flow|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
254514|NCT01377233|P4|Participant Flow|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
254515|NCT01377233|P3|Participant Flow|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
254516|NCT01377233|P2|Participant Flow|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
254517|NCT01377233|P1|Participant Flow|Zicronapine Open-label 10 mg Daily|Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label
254518|NCT01377233|O4|Outcome|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
255686|NCT01373450|O1|Outcome|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
254519|NCT01377233|O3|Outcome|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
254520|NCT01377233|O2|Outcome|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
254521|NCT01377233|O1|Outcome|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
254522|NCT01377233|O4|Outcome|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
254523|NCT01377233|O3|Outcome|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
254524|NCT01377233|O2|Outcome|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
254525|NCT01377233|O1|Outcome|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
254526|NCT01377233|O4|Outcome|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
254527|NCT01377233|O3|Outcome|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
254528|NCT01377233|O2|Outcome|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
254529|NCT01377233|O1|Outcome|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
254530|NCT01377233|O5|Outcome|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
254531|NCT01377233|O4|Outcome|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
254532|NCT01377233|O3|Outcome|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
254533|NCT01377233|O2|Outcome|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
254534|NCT01377233|O1|Outcome|Zicronapine Open-label 10 mg Daily|Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label
254535|NCT01377233|E5|Reported Event|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
254536|NCT01377233|E4|Reported Event|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
254537|NCT01377233|E3|Reported Event|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
254538|NCT01377233|E2|Reported Event|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
254539|NCT01377233|E1|Reported Event|Zicronapine Open-label 10 mg Daily|Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label
254540|NCT01377194|B4|Baseline|Total|Total of all reporting groups
254541|NCT01377194|B3|Baseline|Levomilnacipran 80 mg|40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.
254542|NCT01377194|B2|Baseline|Levomilnacipran ER 40 mg|40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.
254543|NCT01377194|B1|Baseline|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks.
254544|NCT01377194|P3|Participant Flow|Levomilnacipran ER 80 mg|80mg of Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks
254545|NCT01377194|P2|Participant Flow|Levomilnacipran ER 40 mg|40mg of Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks
254546|NCT01377194|P1|Participant Flow|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks.
254547|NCT01377194|O3|Outcome|Levomilnacipran ER 80 mg|80mg of Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks
254548|NCT01377194|O2|Outcome|Levomilnacipran ER 40 mg|40mg Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks
254549|NCT01377194|O1|Outcome|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks.
254550|NCT01377194|O3|Outcome|Levomilnacipran ER 80 mg|80mg of Levomilnacipran ER oral administration in capsule form, once daily for 8 weeks
254551|NCT01377194|O2|Outcome|Levomilnacipran ER 40 mg|40mg Levomilnacipran ER oral administration in capsule form, once daily, for 8 weeks.
254552|NCT01377194|O1|Outcome|Placebo|Dose matched placebo oral administration in capsule form, once daily, for 8 weeks.
254553|NCT01377194|E3|Reported Event|Levomilnacipran 80 mg|40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.
254554|NCT01377194|E2|Reported Event|Levomilnacipran ER 40 mg|40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.
254555|NCT01377194|E1|Reported Event|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks.
254556|NCT01377012|B4|Baseline|Total|Total of all reporting groups
254557|NCT01377012|B3|Baseline|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
254558|NCT01377012|B2|Baseline|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
254559|NCT01377012|B1|Baseline|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
254591|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
269071|NCT01333397|O2|Outcome|Dysport NG 20 U|
254560|NCT01377012|P3|Participant Flow|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
254561|NCT01377012|P2|Participant Flow|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
254562|NCT01377012|P1|Participant Flow|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks up to Week 100, then AIN457 150 mg s.c. starting at week 104
254563|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
254564|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
254565|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
254566|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
254567|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
254568|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
254569|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
254570|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
254571|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
254572|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
254573|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
254574|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
254575|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
254576|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
254577|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
254578|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
254579|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
254580|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
254581|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
254582|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
254583|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
254584|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
254585|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
254586|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
254587|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
254588|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
254589|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
254590|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
254592|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
254593|NCT01377012|E3|Reported Event|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16 of core. Responders were switched to active treatment in week 24 of core
254594|NCT01377012|E2|Reported Event|Any AIN457 150 mg|Group contains all patients from the core and the extension that ever received AIN 150mg. This includes : participants who were randomized to AIN457 150 mg arm to receive AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 injected every 4 weeks + participants who were re-randomized to switch from placebo to AIN457 150 mg at week 16 or week 24 + participants who completed core study in any arm and continued in the extension study to receive AIN457 150 mg as open-label study drug
254595|NCT01377012|E1|Reported Event|Any AIN457 75 mg|Group contains all patients who received AIN 75mg during core period of the study. Includes : participants who were randomized to receive AIN457 i.v (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 injected every 4 weeks + participants who were re-randomized to switch from placebo to AIN457 75 mg at week 16 or week 24 of core study
254596|NCT01376908|B3|Baseline|Total|Total of all reporting groups
254597|NCT01376908|B2|Baseline|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254598|NCT01376908|B1|Baseline|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254599|NCT01376908|P2|Participant Flow|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254600|NCT01376908|P1|Participant Flow|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254601|NCT01376908|O1|Outcome|Population PK Analysis Set|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254602|NCT01376908|O1|Outcome|Population PK Analysis Set|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254603|NCT01376908|O1|Outcome|Population PK Analysis Set|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254604|NCT01376908|O3|Outcome|Population PK Analysis Set: Age Group 2 (>= 2 Years)|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254605|NCT01376908|O2|Outcome|Population PK Analysis Set: Age Group 2 (1 to 2 Years)|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254606|NCT01376908|O1|Outcome|Population PK Analysis Set: Age Group 1 (< 1 Year)|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
261071|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
254607|NCT01376908|O1|Outcome|Population PK Analysis Set|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254608|NCT01376908|O1|Outcome|Population PK Analysis Set|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254609|NCT01376908|O1|Outcome|Pharmacogenetic Evaluation|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254610|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254611|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254612|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria. After 26 weeks, the starting dose of Kuvan will be 10 mg/kg/day, and the dose may be adjusted by the Investigator, if clinically indicated, but it may not exceed 20 mg/kg/day.
254613|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.After 26 weeks, the dose may be adjusted by the Investigator, if clinically indicated, but it may not exceed 20 mg/kg/day.
254614|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254615|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254616|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254617|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254618|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254619|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254620|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254621|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254622|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254623|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254624|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
255687|NCT01373450|E4|Reported Event|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
254625|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254626|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254627|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254628|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254629|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254630|NCT01376908|E2|Reported Event|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254631|NCT01376908|E1|Reported Event|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
254632|NCT01376804|B1|Baseline|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
254633|NCT01376804|P1|Participant Flow|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose [in milligrams (mg)] was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
254634|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
254635|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
254636|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
254637|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
254638|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
254639|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
254640|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
254641|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
254642|NCT01376804|E1|Reported Event|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
254643|NCT01376700|B1|Baseline|ADVATE - Prophylactic Regimen|Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
254644|NCT01376700|P1|Participant Flow|ADVATE - Prophylactic Regimen|Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
254645|NCT01376700|O2|Outcome|MTPs|≤4 previous FVIII exposures
254646|NCT01376700|O1|Outcome|PUPs|No previous FVIII exposure
254647|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
254713|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
254714|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
254648|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
254649|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
254650|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
254651|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
254652|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
254653|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
254654|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
254655|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
254656|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
254657|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
254715|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
254716|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
254717|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
255688|NCT01373450|E3|Reported Event|Liraglutide 1.2 mg|Liraglutide 1.2 mg subcutaneous
254658|NCT01376700|E1|Reported Event|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
254659|NCT01376557|B6|Baseline|Total|Total of all reporting groups
254660|NCT01376557|B5|Baseline|Placebo qd|Placebo: Subjects will receive placebo once daily.
254661|NCT01376557|B4|Baseline|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
254662|NCT01376557|B3|Baseline|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
254663|NCT01376557|B2|Baseline|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
254664|NCT01376557|B1|Baseline|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
254665|NCT01376557|P5|Participant Flow|Placebo qd|Placebo: Subjects will receive placebo once daily.
254666|NCT01376557|P4|Participant Flow|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
254667|NCT01376557|P3|Participant Flow|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
254668|NCT01376557|P2|Participant Flow|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
254669|NCT01376557|P1|Participant Flow|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
254670|NCT01376557|O5|Outcome|Placebo qd|Placebo: Subjects will receive placebo once daily.
254671|NCT01376557|O4|Outcome|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
254672|NCT01376557|O3|Outcome|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
254673|NCT01376557|O2|Outcome|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
254674|NCT01376557|O1|Outcome|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
254675|NCT01376557|O5|Outcome|Placebo qd|Placebo: Subjects will receive placebo once daily.
254676|NCT01376557|O4|Outcome|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
254677|NCT01376557|O3|Outcome|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
254678|NCT01376557|O2|Outcome|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
254679|NCT01376557|O1|Outcome|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
254680|NCT01376557|O5|Outcome|Placebo qd|Placebo: Subjects will receive placebo once daily.
254681|NCT01376557|O4|Outcome|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
254682|NCT01376557|O3|Outcome|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
254683|NCT01376557|O2|Outcome|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
254684|NCT01376557|O1|Outcome|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
254685|NCT01376557|O5|Outcome|Placebo qd|Placebo: Subjects will receive placebo once daily.
254686|NCT01376557|O4|Outcome|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
254687|NCT01376557|O3|Outcome|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
254688|NCT01376557|O2|Outcome|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
254689|NCT01376557|O1|Outcome|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
254690|NCT01376557|O5|Outcome|Placebo qd|Placebo: Subjects will receive placebo once daily.
254691|NCT01376557|O4|Outcome|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
254692|NCT01376557|O3|Outcome|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
254693|NCT01376557|O2|Outcome|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
254694|NCT01376557|O1|Outcome|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
254695|NCT01376557|O5|Outcome|Placebo qd|Placebo: Subjects will receive placebo once daily.
254696|NCT01376557|O4|Outcome|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
254697|NCT01376557|O3|Outcome|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
254698|NCT01376557|O2|Outcome|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
254699|NCT01376557|O1|Outcome|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
254700|NCT01376557|E5|Reported Event|Placebo qd|Placebo: Subjects will receive placebo once daily.
254701|NCT01376557|E4|Reported Event|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
254702|NCT01376557|E3|Reported Event|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
254703|NCT01376557|E2|Reported Event|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
254704|NCT01376557|E1|Reported Event|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
254705|NCT01376388|B1|Baseline|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
254706|NCT01376388|P1|Participant Flow|UMEC/VI 125/25 µg|Participants received GSK573719/GW642444 (UMEC/VI) 125/25 micrograms (µg) inhalation powder via a dry powder inhaler (DPI) once daily (OD) in the morning for 52 weeks.
254707|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
254708|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
254709|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
254710|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
254711|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
254712|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
255689|NCT01373450|E2|Reported Event|Liraglutide 0.6 mg|Liraglutide 0.6 mg subcutaneous
254718|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
254719|NCT01376388|E1|Reported Event|GSK573719/GW642444|125/25mcg
254720|NCT01376362|B1|Baseline|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
254721|NCT01376362|P1|Participant Flow|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
254722|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
254723|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
254724|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
254725|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
254726|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
254727|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
254728|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
254729|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
254730|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
254731|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
254732|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
254733|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
254734|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
254758|NCT01376323|B2|Baseline|GSK256073 5 mg BID|Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.
255690|NCT01373450|E1|Reported Event|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
254735|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
254736|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
254737|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
254738|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
254739|NCT01376362|E1|Reported Event|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
254740|NCT01376349|B4|Baseline|Total|Total of all reporting groups
254741|NCT01376349|B3|Baseline|Arm III Placebo|"Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks. >~> There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study."
254742|NCT01376349|B2|Baseline|Arm II High Dose DHEA|Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
254743|NCT01376349|B1|Baseline|Arm I Low Dose DHEA|Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone [DHEA]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
254744|NCT01376349|P3|Participant Flow|Arm III Placebo|"Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks.~There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study."
254745|NCT01376349|P2|Participant Flow|Arm II High Dose DHEA|Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
254746|NCT01376349|P1|Participant Flow|Arm I Low Dose DHEA|Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone [DHEA]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
254747|NCT01376349|O3|Outcome|Arm III Placebo|"Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks.~There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study."
254748|NCT01376349|O2|Outcome|Arm II High Dose DHEA|Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
254749|NCT01376349|O1|Outcome|Arm I Low Dose DHEA|Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone [DHEA]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
254750|NCT01376349|E4|Reported Event|Optional Continuation Phase|"Patients randomized to Arm III Placebo who have completed protocol treatment for 12 weeks were offered the option of continuing treatment according to Arm II High Dose DHEA until unacceptable adverse events or patient refusal to continue participation on the study.~94 of the 147 patients randomized to the Placebo arm opted to continue treatment with High Dose DHEA."
254751|NCT01376349|E3|Reported Event|Arm III: Placebo|"Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks.~There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study."
254752|NCT01376349|E2|Reported Event|Arm II: High Dose DHEA|Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
254753|NCT01376349|E1|Reported Event|Arm I: Low Dose DHEA|Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone [DHEA]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
254754|NCT01376323|B6|Baseline|Total|Total of all reporting groups
254755|NCT01376323|B5|Baseline|GSK256073 50 mg Once Daily|Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254756|NCT01376323|B4|Baseline|GSK256073 25 mg BID|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254757|NCT01376323|B3|Baseline|GSK256073 10 mg Once Daily|Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
261072|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
254759|NCT01376323|B1|Baseline|Placebo (Pooled)|Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.
254760|NCT01376323|P5|Participant Flow|GSK256073 50 mg Once Daily|Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254761|NCT01376323|P4|Participant Flow|GSK256073 25 mg BID|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254762|NCT01376323|P3|Participant Flow|GSK256073 10 mg Once Daily|Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254763|NCT01376323|P2|Participant Flow|GSK256073 5 mg BID|Eligible participants in this arm received GSK256073 5 milligrams (mg) capsules BID orally as directed with water for 12 weeks in a fed state.
254764|NCT01376323|P1|Participant Flow|Placebo (Pooled)|Eligible participants in this arm received GSK256073 matching placebo capsules twice a day (BID) and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.
254765|NCT01376323|O5|Outcome|GSK256073 50 mg Once Daily|Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254766|NCT01376323|O4|Outcome|GSK256073 25 mg BID|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254767|NCT01376323|O3|Outcome|GSK256073 10 mg Once Daily|Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254768|NCT01376323|O2|Outcome|GSK256073 5 mg BID|Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254769|NCT01376323|O1|Outcome|Placebo (Pooled)|Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.
254770|NCT01376323|O5|Outcome|GSK256073 50 mg Once Daily|Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254771|NCT01376323|O4|Outcome|GSK256073 25 mg BID|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254772|NCT01376323|O3|Outcome|GSK256073 10 mg Once Daily|Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254773|NCT01376323|O2|Outcome|GSK256073 5 mg BID|Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254774|NCT01376323|O1|Outcome|Placebo (Pooled)|Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.
254775|NCT01376323|O5|Outcome|GSK256073 50 mg Once Daily|Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254776|NCT01376323|O4|Outcome|GSK256073 25 mg BID|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254777|NCT01376323|O3|Outcome|GSK256073 10 mg Once Daily|Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254778|NCT01376323|O2|Outcome|GSK256073 5 mg BID|Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254779|NCT01376323|O1|Outcome|Placebo (Pooled)|Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.
254780|NCT01376323|O5|Outcome|GSK256073 50 mg qd|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254781|NCT01376323|O4|Outcome|GSK256073 25 mg BID|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254782|NCT01376323|O3|Outcome|GSK256073 10 mg qd|Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254783|NCT01376323|O2|Outcome|GSK256073 5 mg BID|Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254784|NCT01376323|O1|Outcome|Placebo (Pooled)|Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.
254785|NCT01376323|O5|Outcome|GSK256073 50 mg Once Daily|Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254786|NCT01376323|O4|Outcome|GSK256073 25 mg BID|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
269072|NCT01333397|O1|Outcome|Placebo|
254787|NCT01376323|O3|Outcome|GSK256073 10 mg Once Daily|Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254788|NCT01376323|O2|Outcome|GSK256073 5 mg BID|Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254789|NCT01376323|O1|Outcome|Placebo (Pooled)|Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.
254790|NCT01376323|O5|Outcome|GSK256073 50 mg Once Daily|Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254791|NCT01376323|O4|Outcome|GSK256073 25 mg BID|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254792|NCT01376323|O3|Outcome|GSK256073 10 mg Once Daily|Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254793|NCT01376323|O2|Outcome|GSK256073 5 mg BID|Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254794|NCT01376323|O1|Outcome|Placebo (Pooled)|Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.
254795|NCT01376323|O5|Outcome|GSK256073 50 mg qd|Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254796|NCT01376323|O4|Outcome|GSK256073 25 mg Bid|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254797|NCT01376323|O3|Outcome|GSK256073 10 mg qd|Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254798|NCT01376323|O2|Outcome|GSK256073 5 mg Bid|Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254799|NCT01376323|O1|Outcome|Placebo (Pooled)|Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.
254800|NCT01376323|O5|Outcome|GSK256073 50 mg Once Daily|Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254801|NCT01376323|O4|Outcome|GSK256073 25 mg BID|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254802|NCT01376323|O3|Outcome|GSK256073 10 mg Once Daily|Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254803|NCT01376323|O2|Outcome|GSK256073 5 mg BID|Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254804|NCT01376323|O1|Outcome|Placebo (Pooled)|Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.
254805|NCT01376323|O5|Outcome|GSK256073 50 mg Once Daily|Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254806|NCT01376323|O4|Outcome|GSK256073 25 mg BID|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254807|NCT01376323|O3|Outcome|GSK256073 10 mg Once Daily|Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254808|NCT01376323|O2|Outcome|GSK256073 5 mg BID|Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254809|NCT01376323|O1|Outcome|Placebo (Pooled)|Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.
254810|NCT01376323|O5|Outcome|GSK256073 50 mg Once Daily|Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254811|NCT01376323|O4|Outcome|GSK256073 25 mg BID|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254812|NCT01376323|O3|Outcome|GSK256073 10 mg Once Daily|Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254813|NCT01376323|O2|Outcome|GSK256073 5 mg BID|Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254814|NCT01376323|O1|Outcome|Placebo (Pooled)|Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.
261073|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
254815|NCT01376323|O5|Outcome|GSK256073 50 mg Once Daily|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254816|NCT01376323|O4|Outcome|GSK256073 25 mg BID|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254817|NCT01376323|O3|Outcome|GSK256073 10 mg Once Daily|Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254818|NCT01376323|O2|Outcome|GSK256073 5 mg BID|Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254819|NCT01376323|O1|Outcome|Placebo (Pooled)|Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.
254820|NCT01376323|O5|Outcome|GSK256073 50 mg Once Daily|Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254821|NCT01376323|O4|Outcome|GSK256073 25 mg BID|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254822|NCT01376323|O3|Outcome|GSK256073 10 mg Once Daily|Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254823|NCT01376323|O2|Outcome|GSK256073 5 mg BID|Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254824|NCT01376323|O1|Outcome|Placebo (Pooled)|Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.
254825|NCT01376323|O5|Outcome|GSK256073 50mg Once Daily|Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254826|NCT01376323|O4|Outcome|GSK256073 25mg BID|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254827|NCT01376323|O3|Outcome|GSK256073 10mg Once Daily|Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254828|NCT01376323|O2|Outcome|GSK256073 5mg BID|Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254829|NCT01376323|O1|Outcome|Placebo (Pooled)|Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.
254830|NCT01376323|O5|Outcome|GSK256073 50mg Once Daily|Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254831|NCT01376323|O4|Outcome|GSK256073 25mg BID|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254832|NCT01376323|O3|Outcome|GSK256073 10mg Once Daily|Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254833|NCT01376323|O2|Outcome|GSK256073 5mg BID|Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254834|NCT01376323|O1|Outcome|Placebo (Pooled)|Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.
254835|NCT01376323|O5|Outcome|GSK256073 50 mg Once Daily|Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254836|NCT01376323|O4|Outcome|GSK256073 25 mg BID|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254837|NCT01376323|O3|Outcome|GSK256073 10 mg Once Daily|Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254838|NCT01376323|O2|Outcome|GSK256073 5 mg BID|Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254839|NCT01376323|O1|Outcome|Placebo (Pooled)|Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.
254840|NCT01376323|E5|Reported Event|GSK256073 50 mg Once Daily|Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254841|NCT01376323|E4|Reported Event|GSK256073 25 mg BID|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
254842|NCT01376323|E3|Reported Event|GSK256073 10 mg Once Daily|Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
254843|NCT01376323|E2|Reported Event|GSK256073 5 mg BID|Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.
255006|NCT01375777|P4|Participant Flow|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
254844|NCT01376323|E1|Reported Event|Placebo (Pooled)|Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.
254845|NCT01376297|B3|Baseline|Total|Total of all reporting groups
254846|NCT01376297|B2|Baseline|Aprepitant and Palonosetron Plus Dexamethasone|"Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle.~Aprepitant~Palonosetron~Dexamethasone"
254847|NCT01376297|B1|Baseline|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
254848|NCT01376297|P2|Participant Flow|Aprepitant and Palonosetron Plus Dexamethasone|"Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle.~Aprepitant~Palonosetron~Dexamethasone"
254849|NCT01376297|P1|Participant Flow|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
254850|NCT01376297|O2|Outcome|Aprepitant and Palonosetron Plus Dexamethasone|"Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle.~Aprepitant~Palonosetron~Dexamethasone"
254851|NCT01376297|O1|Outcome|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
254852|NCT01376297|E2|Reported Event|Aprepitant and Palonosetron Plus Dexamethasone|"Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle.~Aprepitant~Palonosetron~Dexamethasone"
254853|NCT01376297|E1|Reported Event|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
254854|NCT01376245|B5|Baseline|Total|Total of all reporting groups
254855|NCT01376245|B4|Baseline|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
254856|NCT01376245|B3|Baseline|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
254857|NCT01376245|B2|Baseline|FF /VI 50/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
254858|NCT01376245|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
254859|NCT01376245|P5|Participant Flow|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
254860|NCT01376245|P4|Participant Flow|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
254861|NCT01376245|P3|Participant Flow|FF /VI 50/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
254862|NCT01376245|P2|Participant Flow|Placebo|Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
254863|NCT01376245|P1|Participant Flow|Placebo- Run-in|Participants received placebo once daily (OD) in the morning for 2 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
254864|NCT01376245|O4|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
254865|NCT01376245|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
254866|NCT01376245|O2|Outcome|FF/VI 50/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
254867|NCT01376245|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
254868|NCT01376245|O4|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
254869|NCT01376245|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
255007|NCT01375777|P3|Participant Flow|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
254870|NCT01376245|O2|Outcome|FF/VI 50/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
254871|NCT01376245|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
254872|NCT01376245|E4|Reported Event|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
254873|NCT01376245|E3|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
254874|NCT01376245|E2|Reported Event|FF/VI 50/25 µg OD|articipants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
254875|NCT01376245|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
254876|NCT01376167|B4|Baseline|Total|Total of all reporting groups
254877|NCT01376167|B3|Baseline|PQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. Participants were dosed with TQ placebo either on Day 1 or Day 2 and PQ 15 mg was administered once daily for 14 days starting from either Day 1 or Day 2.
254878|NCT01376167|B2|Baseline|TQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and Day 2 and CQ 300 mg on Day 3. Participants were dosed with TQ 300 mg either on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254879|NCT01376167|B1|Baseline|CQ Only|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. TQ placebo was administered on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254880|NCT01376167|P3|Participant Flow|PQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. Participants were dosed with TQ placebo either on Day 1 or Day 2 and PQ 15 mg was administered once daily for 14 days starting from either Day 1 or Day 2.
254881|NCT01376167|P2|Participant Flow|TQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and Day 2 and CQ 300 mg on Day 3. Participants were dosed with TQ 300 mg either on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254882|NCT01376167|P1|Participant Flow|CQ Only|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. TQ placebo was administered on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254883|NCT01376167|O1|Outcome|Participants in TQ Only Arms|TQ only arms
254884|NCT01376167|O1|Outcome|Participants in TQ Only Arms|TQ only arms
254885|NCT01376167|O2|Outcome|First Malaria Recurrence Follow-up|Participants from all treatment arms (CQ only, CQ+TQ and PQ+TQ) who had a follow-up visit for recurrence episode of malaria were included.
254886|NCT01376167|O1|Outcome|First Malaria Recurrence|Participants from all treatment arms (CQ only, CQ+TQ and PQ+TQ) with a recurrence episode of malaria were included.
254887|NCT01376167|O2|Outcome|First Malaria Recurrence Follow-up|Participants from all treatment arms (CQ only, CQ+TQ and PQ+TQ) who had a follow-up visit for recurrence episode of malaria were included.
254888|NCT01376167|O1|Outcome|First Malaria Recurrence|Participants from all treatment arms (CQ only, CQ+TQ and PQ+TQ) with a recurrence episode of malaria were included.
254889|NCT01376167|O2|Outcome|First Malaria Recurrence Follow-up|Participants from all treatment arms (CQ only, CQ+TQ and PQ+TQ) who had a follow-up visit for recurrence episode of malaria were included.
254890|NCT01376167|O1|Outcome|First Malaria Recurrence|Participants from all treatment arms (CQ only, CQ+TQ and PQ+TQ) with a recurrence episode of malaria were included.
254891|NCT01376167|O2|Outcome|First Malaria Recurrence Follow-up|Participants from all treatment arms (CQ only, CQ+TQ and PQ+TQ) who had a follow-up visit for recurrence episode of malaria were included.
254892|NCT01376167|O1|Outcome|First Malaria Recurrence|Participants from all treatment arms (CQ only, CQ+TQ and PQ+TQ) with a recurrence episode of malaria were included.
254893|NCT01376167|O3|Outcome|PQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. Participants were dosed with TQ placebo either on Day 1 or Day 2 and PQ 15 mg was administered once daily for 14 days starting from either Day 1 or Day 2.
254894|NCT01376167|O2|Outcome|TQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and Day 2 and CQ 300 mg on Day 3. Participants were dosed with TQ 300 mg either on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254895|NCT01376167|O1|Outcome|CQ Only|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. TQ placebo was administered on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254896|NCT01376167|O3|Outcome|PQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. Participants were dosed with TQ placebo either on Day 1 or Day 2 and PQ 15 mg was administered once daily for 14 days starting from either Day 1 or Day 2.
254897|NCT01376167|O2|Outcome|TQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and Day 2 and CQ 300 mg on Day 3. Participants were dosed with TQ 300 mg either on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254898|NCT01376167|O1|Outcome|CQ Only|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. TQ placebo was administered on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
255008|NCT01375777|P2|Participant Flow|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
269073|NCT01333397|O5|Outcome|Dysport 50 U|
254899|NCT01376167|O3|Outcome|PQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. Participants were dosed with TQ placebo either on Day 1 or Day 2 and PQ 15 mg was administered once daily for 14 days starting from either Day 1 or Day 2.
254900|NCT01376167|O2|Outcome|TQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and Day 2 and CQ 300 mg on Day 3. Participants were dosed with TQ 300 mg either on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254901|NCT01376167|O1|Outcome|CQ Only|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. TQ placebo was administered on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254902|NCT01376167|O3|Outcome|PQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. Participants were dosed with TQ placebo either on Day 1 or Day 2 and PQ 15 mg was administered once daily for 14 days starting from either Day 1 or Day 2.
254903|NCT01376167|O2|Outcome|TQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and Day 2 and CQ 300 mg on Day 3. Participants were dosed with TQ 300 mg either on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254904|NCT01376167|O1|Outcome|CQ Only|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. TQ placebo was administered on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254905|NCT01376167|O3|Outcome|PQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. Participants were dosed with TQ placebo either on Day 1 or Day 2 and PQ 15 mg was administered once daily for 14 days starting from either Day 1 or Day 2.
254906|NCT01376167|O2|Outcome|TQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and Day 2 and CQ 300 mg on Day 3. Participants were dosed with TQ 300 mg either on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254907|NCT01376167|O1|Outcome|CQ Only|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. TQ placebo was administered on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254908|NCT01376167|O3|Outcome|PQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. Participants were dosed with TQ placebo either on Day 1 or Day 2 and PQ 15 mg was administered once daily for 14 days starting from either Day 1 or Day 2.
254909|NCT01376167|O2|Outcome|TQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and Day 2 and CQ 300 mg on Day 3. Participants were dosed with TQ 300 mg either on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254910|NCT01376167|O1|Outcome|CQ Only|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. TQ placebo was administered on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254911|NCT01376167|O3|Outcome|PQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. Participants were dosed with TQ placebo either on Day 1 or Day 2 and PQ 15 mg was administered once daily for 14 days starting from either Day 1 or Day 2.
254912|NCT01376167|O2|Outcome|TQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and Day 2 and CQ 300 mg on Day 3. Participants were dosed with TQ 300 mg either on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254913|NCT01376167|O1|Outcome|CQ Only|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. TQ placebo was administered on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254914|NCT01376167|O3|Outcome|PQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. Participants were dosed with TQ placebo either on Day 1 or Day 2 and PQ 15 mg was administered once daily for 14 days starting from either Day 1 or Day 2.
254915|NCT01376167|O2|Outcome|TQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and Day 2 and CQ 300 mg on Day 3. Participants were dosed with TQ 300 mg either on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254916|NCT01376167|O1|Outcome|CQ Only|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. TQ placebo was administered on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254917|NCT01376167|O3|Outcome|PQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. Participants were dosed with TQ placebo either on Day 1 or Day 2 and PQ 15 mg was administered once daily for 14 days starting from either Day 1 or Day 2.
254918|NCT01376167|O2|Outcome|TQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and Day 2 and CQ 300 mg on Day 3. Participants were dosed with TQ 300 mg either on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254919|NCT01376167|O1|Outcome|CQ Only|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. TQ placebo was administered on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254920|NCT01376167|O3|Outcome|PQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. Participants were dosed with TQ placebo either on Day 1 or Day 2 and PQ 15 mg was administered once daily for 14 days starting from either Day 1 or Day 2.
254921|NCT01376167|O2|Outcome|TQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and Day 2 and CQ 300 mg on Day 3. Participants were dosed with TQ 300 mg either on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254922|NCT01376167|O1|Outcome|CQ Only|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. TQ placebo was administered on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
255009|NCT01375777|P1|Participant Flow|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
254923|NCT01376167|O3|Outcome|PQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. Participants were dosed with TQ placebo either on Day 1 or Day 2 and PQ 15 mg was administered once daily for 14 days starting from either Day 1 or Day 2.
254924|NCT01376167|O2|Outcome|TQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and Day 2 and CQ 300 mg on Day 3. Participants were dosed with TQ 300 mg either on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254925|NCT01376167|O1|Outcome|CQ Only|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. TQ placebo was administered on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254926|NCT01376167|O3|Outcome|PQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. Participants were dosed with TQ placebo either on Day 1 or Day 2 and PQ 15 mg was administered once daily for 14 days starting from either Day 1 or Day 2.
254927|NCT01376167|O2|Outcome|TQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and Day 2 and CQ 300 mg on Day 3. Participants were dosed with TQ 300 mg either on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254928|NCT01376167|O1|Outcome|CQ Only|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. TQ placebo was administered on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254929|NCT01376167|O3|Outcome|PQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. Participants were dosed with TQ placebo either on Day 1 or Day 2 and PQ 15 mg was administered once daily for 14 days starting from either Day 1 or Day 2.
254930|NCT01376167|O2|Outcome|TQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and Day 2 and CQ 300 mg on Day 3. Participants were dosed with TQ 300 mg either on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254931|NCT01376167|O1|Outcome|CQ Only|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. TQ placebo was administered on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254932|NCT01376167|O3|Outcome|PQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. Participants were dosed with TQ placebo either on Day 1 or Day 2 and PQ 15 mg was administered once daily for 14 days starting from either Day 1 or Day 2.
254933|NCT01376167|O2|Outcome|TQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and Day 2 and CQ 300 mg on Day 3. Participants were dosed with TQ 300 mg either on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254934|NCT01376167|O1|Outcome|CQ Only|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. TQ placebo was administered on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254935|NCT01376167|O3|Outcome|PQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. Participants were dosed with TQ placebo either on Day 1 or Day 2 and PQ 15 mg was administered once daily for 14 days starting from either Day 1 or Day 2.
254936|NCT01376167|O2|Outcome|TQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and Day 2 and CQ 300 mg on Day 3. Participants were dosed with TQ 300 mg either on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254937|NCT01376167|O1|Outcome|CQ Only|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. TQ placebo was administered on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254938|NCT01376167|O3|Outcome|PQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. Participants were dosed with TQ placebo either on Day 1 or Day 2 and PQ 15 mg was administered once daily for 14 days starting from either Day 1 or Day 2.
254939|NCT01376167|O2|Outcome|TQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and Day 2 and CQ 300 mg on Day 3. Participants were dosed with TQ 300 mg either on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254940|NCT01376167|O1|Outcome|CQ Only|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. TQ placebo was administered on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254941|NCT01376167|O3|Outcome|PQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. Participants were dosed with TQ placebo either on Day 1 or Day 2 and PQ 15 mg was administered once daily for 14 days starting from either Day 1 or Day 2.
254942|NCT01376167|O2|Outcome|TQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and Day 2 and CQ 300 mg on Day 3. Participants were dosed with TQ 300 mg either on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254943|NCT01376167|O1|Outcome|CQ Only|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. TQ placebo was administered on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254944|NCT01376167|O3|Outcome|PQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. Participants were dosed with TQ placebo either on Day 1 or Day 2 and PQ 15 mg was administered once daily for 14 days starting from either Day 1 or Day 2.
254945|NCT01376167|O2|Outcome|TQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and Day 2 and CQ 300 mg on Day 3. Participants were dosed with TQ 300 mg either on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254946|NCT01376167|O1|Outcome|CQ Only|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. TQ placebo was administered on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
255010|NCT01375777|O9|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
254947|NCT01376167|E3|Reported Event|PQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. Participants were dosed with TQ placebo either on Day 1 or Day 2 and PQ 15 mg was administered once daily for 14 days starting from either Day 1 or Day 2.
254948|NCT01376167|E2|Reported Event|TQ + CQ|Participants were administered a single oral dose of CQ 600 mg on Days 1 and Day 2 and CQ 300 mg on Day 3. Participants were dosed with TQ 300 mg either on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254949|NCT01376167|E1|Reported Event|CQ Only|Participants were administered a single oral dose of CQ 600 mg on Days 1 and 2 and CQ 300 mg on Day 3. TQ placebo was administered on Day 1 or Day 2. PQ placebo capsule was administered once daily for 14 days starting from either Day 1 or Day 2.
254950|NCT01376089|B3|Baseline|Total|Total of all reporting groups
254951|NCT01376089|B2|Baseline|Arm 2-Iopamidol|
254952|NCT01376089|B1|Baseline|Arm 1-Iodixanol|
254953|NCT01376089|P2|Participant Flow|Arm 2-Iopamidol|Subjects were injected with Iopamidol (Isovue).
254954|NCT01376089|P1|Participant Flow|Arm 1-Iodixanol|Subjects were injected with Iodixanol (Visipaque).
254955|NCT01376089|O2|Outcome|Arm 2-Iopamidol (Isovue 370mgI/mL)|Subject injected with Isovue 370mgI/mL contrast media.
254956|NCT01376089|O1|Outcome|Arm 1-Iodixanol (Visipaque 320mgI/mL)|Subjects injected with Visipaque 320mgI/mL contrast media.
254957|NCT01376089|O2|Outcome|Arm 2-Iopamidol (Isovue 370mgI/mL)|Subjects injected with Isovue 370mgI/mL contrast media. Number of subjects with any Moderate / Severe discomfort.
254958|NCT01376089|O1|Outcome|Arm 1-Iodixanol (Visipaque 320mgI/mL)|Subjects injected with Visipaque 320mgI/mL contrast media. Number of subjects with any Moderate / Severe discomfort.
254959|NCT01376089|O2|Outcome|Arm 2-Iopamidol (Isovue)|Subjects injected with Isovue contrast media. Number of subjects with any Moderate / Severe discomfort.
254960|NCT01376089|O1|Outcome|Arm 1-Iodixanol (Visipaque)|Subjects injected with Visipaque contrast media. Number of subjects with any Moderate / Severe discomfort.
254961|NCT01376089|E2|Reported Event|Arm 2-Iopamidol (Isovue 370mgI/mL)|Subject injected with Isovue 370mgI/mL contrast media.
254962|NCT01376089|E1|Reported Event|Arm 1-Iodixanol (Visipaque 320mgI/mL)|Subjects injected with Visipaque 320mgI/mL contrast media.
254963|NCT01376050|B3|Baseline|Total|Total of all reporting groups
254964|NCT01376050|B2|Baseline|Placebo Laser|Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.
254965|NCT01376050|B1|Baseline|Erchonia ML Scanner (MLS)|Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
254966|NCT01376050|P2|Participant Flow|Placebo Laser|Placebo Laser has the same appearance and function as the Erchonia MLS but not does emit any therapeutic output.
254967|NCT01376050|P1|Participant Flow|Erchonia ML Scanner (MLS)|Erchonia ML Scanner (MLS) comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light-emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
254968|NCT01376050|O2|Outcome|Placebo Laser|Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.
254969|NCT01376050|O1|Outcome|Erchonia ML Scanner (MLS)|Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
254970|NCT01376050|O2|Outcome|Placebo Laser|Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.
254971|NCT01376050|O1|Outcome|Erchonia ML Scanner (MLS)|Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
254972|NCT01376050|E2|Reported Event|Placebo Laser|Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.
254973|NCT01376050|E1|Reported Event|Erchonia ML Scanner (MLS)|Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
254974|NCT01376037|B3|Baseline|Total|Total of all reporting groups
254975|NCT01376037|B2|Baseline|Inactive Placebo Laser Device|"The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output.~inactive placebo laser device : The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output."
254976|NCT01376037|B1|Baseline|Erchonia ML Scanner (MLS)|"The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm ed laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern that is totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter.~Erchonia(r) ML Scanner (MLS) : The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm of red laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is a"
254977|NCT01376037|P2|Participant Flow|Inactive Placebo Laser Device|"The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output.~inactive placebo laser device : The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output."
255011|NCT01375777|O8|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
254978|NCT01376037|P1|Participant Flow|Erchonia ML Scanner (MLS)|The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17 milliWatts (mW) 635nm red laser light. The diodes are mounted in scanner devices positioned 120 degrees tileted from each other at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter.
254979|NCT01376037|O2|Outcome|Inactive Placebo Laser Device|"The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output.~inactive placebo laser device : The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output."
254980|NCT01376037|O1|Outcome|Erchonia ML Scanner (MLS)|"The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm ed laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern that is totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter.~Erchonia(r) ML Scanner (MLS) : The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm of red laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is a"
254981|NCT01376037|E2|Reported Event|Inactive Placebo Laser Device|"The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output.~inactive placebo laser device : The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output."
254982|NCT01376037|E1|Reported Event|Erchonia ML Scanner (MLS)|"The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm ed laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern that is totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter.~Erchonia(r) ML Scanner (MLS) : The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm of red laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is a"
254983|NCT01375946|B1|Baseline|AG200-15 Location|The subject will wear AG200-15 for 7 days and be exposed to one of 5 external conditions (normal, treadmill, cold water, whirlpool, dry sauna).
254984|NCT01375946|P1|Participant Flow|AG200-15 Location|The subject will wear AG200-15 for 7 days and be exposed to one of 5 external conditions (normal, treadmill, cold water, whirlpool, dry sauna).
254985|NCT01375946|O1|Outcome|AG200-15 Location|The subject will wear AG200-15 for 7 days and be exposed to one of 5 external conditions (normal, treadmill, cold water, whirlpool, dry sauna).
254986|NCT01375946|O1|Outcome|AG200-15 Location|The subject will wear AG200-15 for 7 days and be exposed to one of 5 external conditions (normal, treadmill, cold water, whirlpool, dry sauna).
254987|NCT01375946|O1|Outcome|AG200-15 Location|The subject will wear AG200-15 for 7 days and be exposed to one of 5 external conditions (normal, treadmill, cold water, whirlpool, dry sauna).
254988|NCT01375946|O1|Outcome|AG200-15 Location|The subject will wear AG200-15 for 7 days and be exposed to one of 5 external conditions (normal, treadmill, cold water, whirlpool, dry sauna).
254989|NCT01375946|O1|Outcome|AG200-15 Location|The subject will wear AG200-15 for 7 days and be exposed to one of 5 external conditions (normal, treadmill, cold water, whirlpool, dry sauna).
254990|NCT01375946|E1|Reported Event|AG200-15 Location|The subject will wear AG200-15 for 7 days and be exposed to one of 5 external conditions (normal, treadmill, cold water, whirlpool, dry sauna).
254991|NCT01375777|B10|Baseline|Total|Total of all reporting groups
254992|NCT01375777|B9|Baseline|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
254993|NCT01375777|B8|Baseline|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
254994|NCT01375777|B7|Baseline|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
254995|NCT01375777|B6|Baseline|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
254996|NCT01375777|B5|Baseline|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
254997|NCT01375777|B4|Baseline|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
254998|NCT01375777|B3|Baseline|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
254999|NCT01375777|B2|Baseline|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
255000|NCT01375777|B1|Baseline|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
255001|NCT01375777|P9|Participant Flow|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255002|NCT01375777|P8|Participant Flow|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255003|NCT01375777|P7|Participant Flow|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255004|NCT01375777|P6|Participant Flow|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
255005|NCT01375777|P5|Participant Flow|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
255012|NCT01375777|O7|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255013|NCT01375777|O6|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
255014|NCT01375777|O5|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
255015|NCT01375777|O4|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
255016|NCT01375777|O3|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
255017|NCT01375777|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
255018|NCT01375777|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
255019|NCT01375777|O9|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255020|NCT01375777|O8|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255021|NCT01375777|O7|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255022|NCT01375777|O6|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
255023|NCT01375777|O5|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
255024|NCT01375777|O4|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
255025|NCT01375777|O3|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
255026|NCT01375777|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
255027|NCT01375777|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
255028|NCT01375777|O9|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255029|NCT01375777|O8|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255030|NCT01375777|O7|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255031|NCT01375777|O6|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
255032|NCT01375777|O5|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
255033|NCT01375777|O4|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
255034|NCT01375777|O3|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
255035|NCT01375777|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
255036|NCT01375777|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
255037|NCT01375777|O9|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255038|NCT01375777|O8|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255039|NCT01375777|O7|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255040|NCT01375777|O6|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
255041|NCT01375777|O5|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
255042|NCT01375777|O4|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
255043|NCT01375777|O3|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
255044|NCT01375777|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
255045|NCT01375777|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
255046|NCT01375777|O9|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255047|NCT01375777|O8|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255048|NCT01375777|O7|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255049|NCT01375777|O6|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
255050|NCT01375777|O5|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
255051|NCT01375777|O4|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
255052|NCT01375777|O3|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
255053|NCT01375777|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
255054|NCT01375777|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
255055|NCT01375777|O9|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255056|NCT01375777|O8|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255057|NCT01375777|O7|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255058|NCT01375777|O6|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
255059|NCT01375777|O5|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
255060|NCT01375777|O4|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
255061|NCT01375777|O3|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
255062|NCT01375777|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
255063|NCT01375777|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
255064|NCT01375777|E9|Reported Event|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255065|NCT01375777|E8|Reported Event|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255066|NCT01375777|E7|Reported Event|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255067|NCT01375777|E6|Reported Event|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
255068|NCT01375777|E5|Reported Event|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
255069|NCT01375777|E4|Reported Event|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
255070|NCT01375777|E3|Reported Event|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
255071|NCT01375777|E2|Reported Event|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
255072|NCT01375777|E1|Reported Event|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
255073|NCT01375764|B6|Baseline|Total|Total of all reporting groups
255074|NCT01375764|B5|Baseline|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255075|NCT01375764|B4|Baseline|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255076|NCT01375764|B3|Baseline|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255077|NCT01375764|B2|Baseline|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
255078|NCT01375764|B1|Baseline|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
255079|NCT01375764|P5|Participant Flow|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255080|NCT01375764|P4|Participant Flow|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255081|NCT01375764|P3|Participant Flow|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255082|NCT01375764|P2|Participant Flow|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
255083|NCT01375764|P1|Participant Flow|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
255084|NCT01375764|O2|Outcome|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
255085|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
255086|NCT01375764|O4|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255087|NCT01375764|O3|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255088|NCT01375764|O2|Outcome|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255089|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
255090|NCT01375764|O2|Outcome|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
255091|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
255092|NCT01375764|O4|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255093|NCT01375764|O3|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255094|NCT01375764|O2|Outcome|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255095|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
255096|NCT01375764|O2|Outcome|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
255097|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
255098|NCT01375764|O4|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255099|NCT01375764|O3|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255100|NCT01375764|O2|Outcome|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255101|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
255102|NCT01375764|O2|Outcome|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
255103|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
255104|NCT01375764|O4|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255105|NCT01375764|O3|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255106|NCT01375764|O2|Outcome|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255107|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
255108|NCT01375764|O2|Outcome|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
255109|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
255110|NCT01375764|O4|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255111|NCT01375764|O3|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255112|NCT01375764|O2|Outcome|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255113|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
255114|NCT01375764|O2|Outcome|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
255115|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
255116|NCT01375764|O4|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255117|NCT01375764|O3|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255118|NCT01375764|O2|Outcome|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255119|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
255120|NCT01375764|E5|Reported Event|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
255121|NCT01375764|E4|Reported Event|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255122|NCT01375764|E3|Reported Event|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255123|NCT01375764|E2|Reported Event|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255124|NCT01375764|E1|Reported Event|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
255125|NCT01375751|B4|Baseline|Total|Total of all reporting groups
255126|NCT01375751|B3|Baseline|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255127|NCT01375751|B2|Baseline|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255128|NCT01375751|B1|Baseline|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
255129|NCT01375751|P3|Participant Flow|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255130|NCT01375751|P2|Participant Flow|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255131|NCT01375751|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
255132|NCT01375751|O3|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255133|NCT01375751|O2|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255134|NCT01375751|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
255135|NCT01375751|O3|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255136|NCT01375751|O2|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255137|NCT01375751|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
255138|NCT01375751|O3|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255139|NCT01375751|O2|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255140|NCT01375751|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
255141|NCT01375751|O3|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255142|NCT01375751|O2|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255143|NCT01375751|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
255144|NCT01375751|O3|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255145|NCT01375751|O2|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255146|NCT01375751|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
255147|NCT01375751|O3|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255148|NCT01375751|O2|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255150|NCT01375751|E3|Reported Event|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255151|NCT01375751|E2|Reported Event|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
255152|NCT01375751|E1|Reported Event|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
255153|NCT01375660|B3|Baseline|Total|Total of all reporting groups
255154|NCT01375660|B2|Baseline|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
255155|NCT01375660|B1|Baseline|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
255156|NCT01375660|P2|Participant Flow|50K Vitamin D2|supplement of vitamin D 400 units provided to all subjects in addition to 50K vitamin D2.
255157|NCT01375660|P1|Participant Flow|Placebo|supplement of vitamin D 400 units provided to all subjects in addition to placebo.
255158|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
255159|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
255160|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
255161|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
255162|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
255163|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
255164|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
255165|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
255166|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
255167|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
255168|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
255169|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to Placebo.
255170|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
255171|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to Placebo.
255172|NCT01375660|E2|Reported Event|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition get to D2 50K.
255173|NCT01375660|E1|Reported Event|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
255174|NCT01375608|B1|Baseline|Subcutaneous Decitabine in Sickle Cell Disease|decitabine (starting dose of 0.20 mg/kg, 2 days per week) to induce fetal hemoglobin (HbF) in patients with sickle cell anemia who are refractory to or intolerant of hydroxyurea
255175|NCT01375608|P1|Participant Flow|Subcutaneous Decitabine in Sickle Cell Disease|decitabine (starting dose of 0.20 mg/kg, 2 days per week) to induce fetal hemoglobin (HbF) in patients with sickle cell anemia who are refractory to or intolerant of hydroxyurea
255176|NCT01375608|O1|Outcome|Subcutaneous Decitabine in Sickle Cell Disease|decitabine (starting dose of 0.20 mg/kg, 2 days per week) to induce fetal hemoglobin (HbF) in patients with sickle cell anemia who are refractory to or intolerant of hydroxyurea
255177|NCT01375608|E1|Reported Event|Subcutaneous Decitabine in Sickle Cell Disease|decitabine (starting dose of 0.20 mg/kg, 2 days per week) to induce fetal hemoglobin (HbF) in patients with sickle cell anemia who are refractory to or intolerant of hydroxyurea
255178|NCT01375569|B1|Baseline|TRC105 in Liver Cancer|TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
255179|NCT01375569|P1|Participant Flow|TRC105 in Liver Cancer|TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
255180|NCT01375569|O1|Outcome|TRC105 in Liver Cancer|TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
255181|NCT01375569|O1|Outcome|TRC105 in Liver Cancer|TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
255182|NCT01375569|E1|Reported Event|TRC105 in Liver Cancer|TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
255183|NCT01375374|B1|Baseline|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets~Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.~8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.~Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
255222|NCT01375127|O5|Outcome|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255184|NCT01375374|P1|Participant Flow|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets~Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.~8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.~Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
255185|NCT01375374|O1|Outcome|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets~Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.~8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.~Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
255186|NCT01375374|O1|Outcome|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets~Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.~8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.~Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
255187|NCT01375374|O1|Outcome|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets~Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.~8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.~Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
255188|NCT01375374|O1|Outcome|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets~Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.~8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.~Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
255189|NCT01375374|E1|Reported Event|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets~Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.~8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.~Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
255190|NCT01375127|B7|Baseline|Total|Total of all reporting groups
255191|NCT01375127|B6|Baseline|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255192|NCT01375127|B5|Baseline|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255193|NCT01375127|B4|Baseline|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255194|NCT01375127|B3|Baseline|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255195|NCT01375127|B2|Baseline|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255196|NCT01375127|B1|Baseline|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
255197|NCT01375127|P6|Participant Flow|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255198|NCT01375127|P5|Participant Flow|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255199|NCT01375127|P4|Participant Flow|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255200|NCT01375127|P3|Participant Flow|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255201|NCT01375127|P2|Participant Flow|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255363|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
255202|NCT01375127|P1|Participant Flow|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
255203|NCT01375127|O6|Outcome|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255204|NCT01375127|O5|Outcome|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255205|NCT01375127|O4|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255206|NCT01375127|O3|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255207|NCT01375127|O2|Outcome|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255208|NCT01375127|O1|Outcome|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
255209|NCT01375127|O6|Outcome|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255210|NCT01375127|O5|Outcome|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255211|NCT01375127|O4|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255212|NCT01375127|O3|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255213|NCT01375127|O2|Outcome|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255214|NCT01375127|O1|Outcome|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
255215|NCT01375127|O6|Outcome|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255216|NCT01375127|O5|Outcome|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255217|NCT01375127|O4|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255218|NCT01375127|O3|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255219|NCT01375127|O2|Outcome|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255220|NCT01375127|O1|Outcome|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
255221|NCT01375127|O6|Outcome|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
256340|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
255223|NCT01375127|O4|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255224|NCT01375127|O3|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255225|NCT01375127|O2|Outcome|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255226|NCT01375127|O1|Outcome|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
255227|NCT01375127|E6|Reported Event|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255228|NCT01375127|E5|Reported Event|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255229|NCT01375127|E4|Reported Event|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255230|NCT01375127|E3|Reported Event|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255231|NCT01375127|E2|Reported Event|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
255232|NCT01375127|E1|Reported Event|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
255233|NCT01375049|B1|Baseline|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
255234|NCT01375049|P1|Participant Flow|AZLI|Participants received one 28-day course of Aztreonam for Inhalation Solution (AZLI), then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
255235|NCT01375049|O1|Outcome|AZLI - Sensitivity Analysis Set|"Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.~The Sensitivity Analysis Set consists of participants who completed study drug and did not receive an additional antipseudomonal antibiotic during the 28-day AZLI treatment course, and either completed the study through Day 196 with PA-negative cultures at every visit without the use of additional antipseudomonal antibiotics from Day 28 through Day 196 or had evidence of a PA-positive culture from Day 28 through Day 196 or used any additional antipseudomonal antibiotics from Day 28 through Day 196."
255236|NCT01375049|O1|Outcome|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
255237|NCT01375049|O1|Outcome|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
255238|NCT01375049|O1|Outcome|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
255239|NCT01375049|O1|Outcome|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
255240|NCT01375049|O1|Outcome|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
255241|NCT01375049|O1|Outcome|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
255242|NCT01375049|O2|Outcome|AZLI - Did Not Meet Primary Efficacy Endpoint|"This group included participants who did not meet the primary efficacy endpoint, defined as having any PA-positive culture at Day 28 through Day 196 or having used anti-PA antibiotics through Day 196.~Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer."
255243|NCT01375049|O1|Outcome|AZLI - Met Primary Efficacy Endpoint|"This group included participants who met the primary efficacy endpoint, defined as having PA-negative cultures at all time points after cessation of active treatment through Day 196.~Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer."
255364|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
255244|NCT01375049|O2|Outcome|AZLI - Did Not Meet Primary Efficacy Endpoint|"This group included participants who did not meet the primary efficacy endpoint, defined as having any PA-positive culture at Day 28 through Day 196 or having used anti-PA antibiotics through Day 196.~Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer."
255245|NCT01375049|O1|Outcome|AZLI - Met Primary Efficacy Endpoint|"This group included participants who met the primary efficacy endpoint, defined as having PA-negative cultures at all time points after cessation of active treatment through Day 196.~Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer."
255246|NCT01375049|O1|Outcome|AZLI - Evaluable Analysis Set|"Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.~The Evaluable Analysis Set consists of participants who completed study drug and did not receive an additional antipseudomonal antibiotic during the 28-day AZLI treatment course, and either completed the study through Day 196 with PA-negative cultures at every visit without the use of additional antipseudomonal antibiotics from Day 28 through Day 196 or had evidence of a positive PA-positive culture from Day 28 through Day 196."
255247|NCT01375049|E1|Reported Event|AZLI|"Treatment-emergent adverse events and treatment-emergent serious adverse events were collected from Baseline through Day 28 plus 30 days.~Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer."
255248|NCT01374971|B1|Baseline|Certolizumab Pegol (CZP)|"Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Certolizumab Pegol (CZP): CZP is an anti-TNF, humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Arthroscopic synovial tissue biopsy: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver."
255249|NCT01374971|P1|Participant Flow|Certolizumab Pegol (CZP)|"Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Certolizumab Pegol (CZP): CZP is an anti-Tumor Necrosis Factor (TNF), humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Arthroscopic synovial tissue biopsy: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver."
255250|NCT01374971|O1|Outcome|Certolizumab Pegol (CZP)|"Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Certolizumab Pegol (CZP): CZP is an anti-TNF, humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Arthroscopic synovial tissue biopsy: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver."
255251|NCT01374971|O1|Outcome|Certolizumab Pegol (CZP)|"Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Certolizumab Pegol (CZP): CZP is an anti-TNF, humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Arthroscopic synovial tissue biopsy: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver."
255252|NCT01374971|E1|Reported Event|Certolizumab Pegol (CZP)|"Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Certolizumab Pegol (CZP): CZP is an anti-TNF, humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Arthroscopic synovial tissue biopsy: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver."
255253|NCT01374919|B1|Baseline|Total Dose 1020 mg Feramoxytol|All participants receive 1020 mg of Feramoxytol.
255254|NCT01374919|P1|Participant Flow|Total Dose 1020 mg Feramoxytol|All participants receive 1020 mg of Feramoxytol.
255255|NCT01374919|O1|Outcome|Total Dose 1020 mg Feramoxytol|All participants receive 1020 mg of Feramoxytol.
255256|NCT01374919|O1|Outcome|Total Dose 1020 mg Feramoxytol|All participants receive 1020 mg of Feramoxytol.
255257|NCT01374919|E1|Reported Event|Total Dose 1020 mg Feramoxytol|All participants receive 1020 mg of Feramoxytol.
255258|NCT01374906|B3|Baseline|Total|Total of all reporting groups
255365|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
255259|NCT01374906|B2|Baseline|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255260|NCT01374906|B1|Baseline|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255261|NCT01374906|P2|Participant Flow|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255262|NCT01374906|P1|Participant Flow|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255263|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255264|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255265|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255266|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255267|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255268|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255269|NCT01374906|O4|Outcome|40 mg Pasireotide LAR Dose|These patients were dosed with 40 mg of Pasireotide LAR to assess Pharmacokinetics (PK).
255270|NCT01374906|O3|Outcome|5 mg Pasireptide LAR Dose|These patients were dosed with 5 mg of Pasireotide LAR to assess Pharmacokinetics (PK).
255271|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255272|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255273|NCT01374906|O4|Outcome|40 mg Pasireotide LAR Dose|These patients were dosed with 40 mg of Pasireotide LAR to assess Pharmacokinetics (PK).
255274|NCT01374906|O3|Outcome|5 mg Pasireotide LAR Dose|These patients were dosed with 5 mg of Pasireotide LAR to assess Pharmacokinetics (PK).
255275|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255276|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255277|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255278|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255279|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255280|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255281|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255282|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255283|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255284|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255285|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255286|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255287|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255288|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255289|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255290|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255291|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255292|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255293|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255294|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255295|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255296|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255297|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255298|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255299|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255300|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255301|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255302|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255303|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255304|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255305|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255306|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255307|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255308|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255309|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255310|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255311|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255312|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255313|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255314|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255315|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255316|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255317|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255318|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
256341|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
255319|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255320|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255321|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255322|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255323|NCT01374906|O2|Outcome|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255324|NCT01374906|O1|Outcome|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255325|NCT01374906|E3|Reported Event|All Patients|All Patients from both the 10 mg and 30 mg groups.
255326|NCT01374906|E2|Reported Event|30 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.
255327|NCT01374906|E1|Reported Event|10 mg Pasireotide LAR Dose|Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.
255328|NCT01374802|B1|Baseline|All Subjects|"The study was performed as an open-label, multiple-dose, single-group, fixed-sequence study in 14 healthy volunteers.~Period 1: darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r).~Period 2: faldaprevir together with DRV/r."
255329|NCT01374802|P1|Participant Flow|All Subjects|"The study was performed as an open-label, multiple-dose, single-group, fixed-sequence study in 14 healthy volunteers.~Period 1: Darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r).~Period 2: Faldaprevir together with DRV/r."
255330|NCT01374802|O2|Outcome|Faldaprevir+Darunavir+Ritonavir|oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
255331|NCT01374802|O1|Outcome|Darunavir+Ritonavir|oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r) once daily
255332|NCT01374802|O2|Outcome|Faldaprevir+Darunavir+Ritonavir|oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
255333|NCT01374802|O1|Outcome|Darunavir+Ritonavir|oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r) once daily
255334|NCT01374802|O2|Outcome|Faldaprevir+Darunavir+Ritonavir|oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
255335|NCT01374802|O1|Outcome|Darunavir+Ritonavir|oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r) once daily
255336|NCT01374802|O2|Outcome|Faldaprevir+Darunavir+Ritonavir|oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
255337|NCT01374802|O1|Outcome|Darunavir+Ritonavir|oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r) once daily
255338|NCT01374802|E2|Reported Event|Faldaprevir+Darunavir+Ritonavir|oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
255339|NCT01374802|E1|Reported Event|Darunavir+Ritonavir|oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r)once daily
255340|NCT01374568|B3|Baseline|Total|Total of all reporting groups
255341|NCT01374568|B2|Baseline|Placebo|"Placebo~Placebo: 1 pill daily"
255342|NCT01374568|B1|Baseline|Sitagliptin|"Sitagliptin~sitagliptin: sitagliptin 100mg daily"
255343|NCT01374568|P2|Participant Flow|Placebo|"Placebo~Placebo: 1 pill daily"
255344|NCT01374568|P1|Participant Flow|Sitagliptin|"Sitagliptin~sitagliptin: sitagliptin 100mg daily"
255345|NCT01374568|O2|Outcome|Placebo|"Placebo~Placebo: 1 pill daily"
255346|NCT01374568|O1|Outcome|Sitagliptin|"Sitagliptin~sitagliptin: sitagliptin 100mg daily"
255347|NCT01374568|O2|Outcome|Placebo|"Placebo~Placebo: 1 pill daily"
255348|NCT01374568|O1|Outcome|Sitagliptin|"Sitagliptin~sitagliptin: sitagliptin 100mg daily"
255349|NCT01374568|E2|Reported Event|Placebo|"Placebo~Placebo: 1 pill daily"
255350|NCT01374568|E1|Reported Event|Sitagliptin|"Sitagliptin~sitagliptin: sitagliptin 100mg daily"
255351|NCT01374451|B3|Baseline|Total|Total of all reporting groups
255352|NCT01374451|B2|Baseline|Everolimus|everolimus 10 mg once daily po alone
255353|NCT01374451|B1|Baseline|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
255354|NCT01374451|P2|Participant Flow|Everolimus|everolimus 10 mg once daily po alone
255355|NCT01374451|P1|Participant Flow|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
255356|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
255357|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
255358|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
255359|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
255360|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
255361|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
255362|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
255366|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
255367|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
255368|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
255369|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
255370|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
255371|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
255372|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
255373|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
255374|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
255375|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
255376|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
255377|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
255378|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
255379|NCT01374451|E2|Reported Event|Everolimus|everolimus 10 mg once daily po alone
255380|NCT01374451|E1|Reported Event|Everolimus LAR + Pasireotide|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
255381|NCT01374438|B3|Baseline|Total|Total of all reporting groups
255382|NCT01374438|B2|Baseline|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
255383|NCT01374438|B1|Baseline|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
255384|NCT01374438|P2|Participant Flow|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
255385|NCT01374438|P1|Participant Flow|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
255386|NCT01374438|O2|Outcome|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
255387|NCT01374438|O1|Outcome|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
255388|NCT01374438|O2|Outcome|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
255389|NCT01374438|O1|Outcome|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
255390|NCT01374438|O2|Outcome|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
255391|NCT01374438|O1|Outcome|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
255392|NCT01374438|O2|Outcome|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
255393|NCT01374438|O1|Outcome|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
255394|NCT01374438|O2|Outcome|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
255395|NCT01374438|O1|Outcome|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
255396|NCT01374438|E2|Reported Event|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
255397|NCT01374438|E1|Reported Event|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
255398|NCT01374425|B3|Baseline|Total|Total of all reporting groups
255399|NCT01374425|B2|Baseline|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
255400|NCT01374425|B1|Baseline|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
255401|NCT01374425|P2|Participant Flow|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus leucovorin, 5-fluorouracil, and irinotecan (FOLFIRI) until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
255494|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255402|NCT01374425|P1|Participant Flow|Bevacizumab + mFOLFOX6|Participants with untreated metastatic colorectal cancer (mCRC) who were candidates for first-line therapy received bevacizumab plus leucovorin, 5-fluorouracil, and oxaliplatin (mFOLFOX6) until disease progression or unacceptable toxicity. Bevacizumab was given as 5 milligrams per kilogram (mg/kg), leucovorin as 400 milligrams per meter-squared (mg/m^2), oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via intravenous (IV) infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
255403|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
255404|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
255405|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
255406|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
255407|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
255408|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
255409|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (KRAS Mutant)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with mutant KRAS at Baseline were included in separate analyses.
255643|NCT01373918|O2|Outcome|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
255410|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (KRAS Wild-Type)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with wild-type KRAS at Baseline were included in separate analyses.
255411|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
255412|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
255413|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (KRAS Mutant)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with mutant KRAS at Baseline were included in separate analyses.
255414|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (KRAS Wild-Type)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with wild-type KRAS at Baseline were included in separate analyses.
255415|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
255416|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
255417|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (KRAS Mutant)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with mutant KRAS at Baseline were included in separate analyses.
255691|NCT01373346|B1|Baseline|Long Limb Roux-en Y Reconstruction|Total or Subtotal gastrectomized gastric cancer patient with long limb Roux en Y reconstruction
256342|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
255418|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (KRAS Wild-Type)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with wild-type KRAS at Baseline were included in separate analyses.
255419|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255420|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255421|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255422|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255423|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255424|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255425|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255506|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255426|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255427|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255428|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255429|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255430|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255431|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
255432|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
255433|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
255434|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
255453|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255435|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255436|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255437|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255438|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255439|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255440|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255441|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
255442|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
255443|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255692|NCT01373346|P1|Participant Flow|Long Limb Roux-en Y Reconstruction|Total or Subtotal gastrectomized gastric cancer patient with long limb Roux en Y reconstruction
255444|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255445|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255446|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255447|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255448|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255449|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
255450|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
255451|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255452|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255806|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
255454|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255455|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255456|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255457|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
255458|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
255459|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low, VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
255460|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low, VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
255461|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low, VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
255462|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low, VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
255644|NCT01373918|O1|Outcome|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
269074|NCT01333397|O4|Outcome|Dysport NG 75 U|
255463|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High, VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
255464|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High, VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
255465|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High, VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
255466|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High, VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
255467|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
255468|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level >5 picograms per milliliter (pg/mL) at Baseline were included in separate analyses.
255469|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255470|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255482|NCT01374269|P2|Participant Flow|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255471|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255472|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level less than or equal to (≤) 1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255473|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
255474|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level greater than (>) 1.7 × 10^-3 ERCC-1/B-actin messenger ribonucleic acid (mRNA) at Baseline were included in separate analyses.
255475|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
255476|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
255477|NCT01374425|E2|Reported Event|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
255478|NCT01374425|E1|Reported Event|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
255479|NCT01374269|B3|Baseline|Total|Total of all reporting groups
255480|NCT01374269|B2|Baseline|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255481|NCT01374269|B1|Baseline|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
256148|NCT01371786|E2|Reported Event|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
255483|NCT01374269|P1|Participant Flow|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255484|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255485|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255486|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255487|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255488|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255489|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255490|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255491|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255492|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255493|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255668|NCT01373450|P3|Participant Flow|Pbo--> OXM--> Lg-0.6-->Pbo|Participants received Placebo in the first, Oxyntomodulin 3.0 pmol/kg/min in the second, Liraglutide 0.6 mg in the third, and Placebo in the fourth period
255495|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255496|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255497|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255498|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255499|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255500|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255501|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255502|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255503|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255504|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255505|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255669|NCT01373450|P2|Participant Flow|Lg-0.6 mg--> Pbo--> OXM--> Pbo|Participants received Liraglutide 0.6 mg in the first, Placebo in the second, Oxyntomodulin 3.0 pmol/kg/min in the third, and Placebo in the fourth period
255507|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255508|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255509|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255510|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255511|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255512|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255513|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255514|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255515|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255516|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255517|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255670|NCT01373450|P1|Participant Flow|OXM --> Lg-0.6--> Pbo--> Lg-1.2|Participants received Oxyntomodulin (OXM) 3.0 pmol/kg/min in the first, Liraglutide (Lg) 0.6 mg in the second, Placebo (Pbo) in the third, and Liraglutide 1.2 mg in the fourth period
255518|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255519|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255520|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255521|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255522|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255523|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255524|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255525|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255526|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255527|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255528|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255540|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255529|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255530|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255531|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255532|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255533|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255534|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255535|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255536|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255537|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255538|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255539|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255671|NCT01373450|O4|Outcome|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
255672|NCT01373450|O3|Outcome|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
255541|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255542|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255543|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255544|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255545|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255546|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255547|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255548|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255549|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255550|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255551|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255673|NCT01373450|O2|Outcome|Liraglutide 1.2 mg|Liraglutide 1.2 mg subcutaneous
255674|NCT01373450|O1|Outcome|Liraglutide 0.6 mg|Liraglutide 0.6 mg subcutaneous
269075|NCT01333397|O3|Outcome|Dysport NG 50 U|
255552|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255553|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255554|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255555|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255556|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255557|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255558|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255559|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255560|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255561|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255562|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255574|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255563|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255564|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255565|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255566|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255567|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255568|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255569|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255570|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255571|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255572|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255573|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255675|NCT01373450|O4|Outcome|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
255676|NCT01373450|O3|Outcome|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
255575|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255576|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255577|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255578|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255579|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255580|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255581|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255582|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255583|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255584|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255585|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255677|NCT01373450|O2|Outcome|Liraglutide 1.2 mg|Liraglutide 1.2 mg subcutaneous
255678|NCT01373450|O1|Outcome|Liraglutide 0.6 mg|Liraglutide 0.6 mg subcutaneous
269076|NCT01333397|O2|Outcome|Dysport NG 20 U|
255586|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255587|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255588|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255589|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255590|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255591|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255592|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255593|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255594|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255595|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255596|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255608|NCT01374269|E2|Reported Event|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255597|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255598|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255599|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255600|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255601|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255602|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255603|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255604|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255605|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255606|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
255607|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255679|NCT01373450|O2|Outcome|Placebo Period 2|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
255680|NCT01373450|O1|Outcome|Placebo Period 1|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
255609|NCT01374269|E1|Reported Event|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
255610|NCT01374178|B1|Baseline|Entire Study Population|"For the LY2963016 first, then Lantus group: A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg Lantus dose was administered subcutaneously during Period 2 (1 period=24 hours).~For the Lantus first, then LY2963016 group: A single 0.5-U/kg dose of Lantus was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg dose of LY2963016 was administered subcutaneously during Period 2 (1 period=24 hours)."
255611|NCT01374178|P2|Participant Flow|Lantus First, Then LY2963016|A single 0.5-U/kg dose of Lantus was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg dose of LY2963016 was administered subcutaneously during Period 2 (1 period=24 hours).
255612|NCT01374178|P1|Participant Flow|LY2963016 First, Then Lantus|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg Lantus dose was administered subcutaneously during Period 2 (1 period=24 hours).
255613|NCT01374178|O2|Outcome|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
255614|NCT01374178|O1|Outcome|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
255615|NCT01374178|O2|Outcome|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
255616|NCT01374178|O1|Outcome|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
255617|NCT01374178|O2|Outcome|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
255618|NCT01374178|O1|Outcome|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
255619|NCT01374178|O2|Outcome|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
255620|NCT01374178|O1|Outcome|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
255621|NCT01374178|O2|Outcome|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
255622|NCT01374178|O1|Outcome|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
255623|NCT01374178|O2|Outcome|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
255624|NCT01374178|O1|Outcome|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
255625|NCT01374178|E2|Reported Event|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
255626|NCT01374178|E1|Reported Event|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
255627|NCT01374087|B3|Baseline|Total|Total of all reporting groups
255628|NCT01374087|B2|Baseline|Brachytherapy|Brachytherapy: Low or high dose rate.
255629|NCT01374087|B1|Baseline|Brachytherapy + Triptorelin 22.5 mg|Brachytherapy: Low or high dose rate. Triptorelin: A single, intramuscular injection (22.5 mg), preferably 2 months before brachytherapy.
255630|NCT01374087|P2|Participant Flow|Brachytherapy|Brachytherapy: Low or high dose rate.
255631|NCT01374087|P1|Participant Flow|Brachytherapy + Triptorelin 22.5 mg|Brachytherapy: Low or high dose rate. Triptorelin: A single, intramuscular injection (22.5 mg), preferably 2 months before brachytherapy.
255632|NCT01374087|O2|Outcome|Brachytherapy|Brachytherapy: Low or high dose rate.
255633|NCT01374087|O1|Outcome|Brachytherapy + Triptorelin 22.5 mg|Brachytherapy: Low or high dose rate. Triptorelin: A single, intramuscular injection (22.5 mg), preferably 2 months before brachytherapy.
255634|NCT01374087|O2|Outcome|Brachytherapy|Brachytherapy: Low or high dose rate.
255635|NCT01374087|O1|Outcome|Brachytherapy + Triptorelin 22.5 mg|Brachytherapy: Low or high dose rate. Triptorelin: A single, intramuscular injection (22.5 mg), preferably 2 months before brachytherapy.
255636|NCT01374087|E2|Reported Event|Brachytherapy|Brachytherapy: Low or high dose rate.
255637|NCT01374087|E1|Reported Event|Brachytherapy + Triptorelin 22.5 mg|Brachytherapy: Low or high dose rate. Triptorelin: A single, intramuscular injection (22.5 mg), preferably 2 months before brachytherapy.
255638|NCT01373918|B3|Baseline|Total|Total of all reporting groups
255639|NCT01373918|B2|Baseline|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
255640|NCT01373918|B1|Baseline|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
255641|NCT01373918|P2|Participant Flow|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
255642|NCT01373918|P1|Participant Flow|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
255681|NCT01373450|O2|Outcome|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
269077|NCT01333397|O1|Outcome|Placebo|
255645|NCT01373918|O2|Outcome|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
255646|NCT01373918|O1|Outcome|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
255647|NCT01373918|O2|Outcome|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
255648|NCT01373918|O1|Outcome|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
255649|NCT01373918|O2|Outcome|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
255650|NCT01373918|O1|Outcome|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
255651|NCT01373918|E2|Reported Event|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
255652|NCT01373918|E1|Reported Event|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
255653|NCT01373671|B1|Baseline|Mammography Exam|"Siemens DBT scan~SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM: DBT scan"
255654|NCT01373671|P1|Participant Flow|Mammography Exam|"Siemens DBT scan~SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM: DBT scan"
255655|NCT01373671|O2|Outcome|FFDM Only|FFDM exam only
255656|NCT01373671|O1|Outcome|FFDM and DBT|FFDM exam and DBT scan on Siemens MAMMOMAT Inspiration
255657|NCT01373671|E1|Reported Event|Mammography Exam|"Siemens DBT scan~SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM: DBT scan"
255658|NCT01373580|B1|Baseline|Raindrop|"A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near vision.~The Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay is implanted in the cornea for treatment of presbyopia"
255659|NCT01373580|P1|Participant Flow|Raindrop|"A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near vision.~The Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay is implanted in the cornea for treatment of presbyopia"
255660|NCT01373580|O1|Outcome|Raindrop|"A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near vision.~The Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay is implanted in the cornea for treatment of presbyopia"
255661|NCT01373580|O1|Outcome|Raindrop|"A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near vision.~The Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay is implanted in the cornea for treatment of presbyopia"
255662|NCT01373580|O1|Outcome|Raindrop|"A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near vision.~The Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay is implanted in the cornea for treatment of presbyopia"
255663|NCT01373580|E1|Reported Event|Raindrop|"A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near vision.~The Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay is implanted in the cornea for treatment of presbyopia"
255664|NCT01373450|B1|Baseline|All Treated Participants|
255665|NCT01373450|P6|Participant Flow|Pbo--> Lg-0.6--> OXM--> Lg-1.2|Participants received Placebo in the first, Liraglutide 0.6 mg in the second, Oxyntomodulin 3.0 pmol/kg/min in the third, and Liraglutide 1.2 mg in the fourth period
255666|NCT01373450|P5|Participant Flow|OXM--> Pbo--> Lg-0.6--> Pbo|Participants received Oxyntomodulin 3.0 pmol/kg/min in the first; Placebo in the second, Liraglutide 0.6 mg in the third, and Placebo in the fourth period
255667|NCT01373450|P4|Participant Flow|Lg-0.6--> OXM--> Pbo--> Lg-1.2|Participants received Liraglutide 0.6 mg in the first, Oxyntomodulin 3.0 pmol/kg/min in the second, Placebo in the third and Liraglutide 1.2 mg in the fourth period
255693|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
255694|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
255695|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
255696|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
255697|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
255698|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
255699|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
255700|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
255701|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction|"Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy.~Until end of study (on average 14.8 months), operation related mortality of Gastric cancer patient with type 2 diabetes who receive total or Subtotal gastrectomy with long limb Roux en Y reconstruction were analyzed."
255702|NCT01373346|O1|Outcome|Long Limb Roux en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
255703|NCT01373346|O1|Outcome|Long Limb Roux en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
255704|NCT01373346|O1|Outcome|Long Limb Roux en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
255705|NCT01373346|O1|Outcome|Long Limb Roux en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
255706|NCT01373346|O1|Outcome|Long Limb Roux en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
255807|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
255808|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
255707|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
255708|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
255709|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction|Morbidity after operation were analyzed until end of study (on average 14.8 months)
255710|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
255711|NCT01373346|E1|Reported Event|Long-limb Roux-en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy.
255712|NCT01373294|B3|Baseline|Total|Total of all reporting groups
255713|NCT01373294|B2|Baseline|B: Control Arm|Bacille Calmette-Guerrin (BCG).
255714|NCT01373294|B1|Baseline|A: Combination Arm|Bacille Calmette-Guerrin (BCG) and lenalidomide.
255715|NCT01373294|P2|Participant Flow|B: Control Arm|Bacille Calmette-Guerrin (BCG).
255716|NCT01373294|P1|Participant Flow|A: Combination Arm|Bacille Calmette-Guerrin (BCG) and lenalidomide.
255717|NCT01373294|O2|Outcome|B: Control Arm|Bacille Calmette-Guerrin (BCG).
255718|NCT01373294|O1|Outcome|A: Combination Arm|Bacille Calmette-Guerrin (BCG) and lenalidomide.
255719|NCT01373294|O1|Outcome|A: Combination Arm|Bacille Calmette-Guerrin (BCG) and lenalidomide.
255720|NCT01373294|E2|Reported Event|B: Control Arm|Bacille Calmette-Guerrin (BCG).
255721|NCT01373294|E1|Reported Event|A: Combination Arm|Bacille Calmette-Guerrin (BCG) and lenalidomide.
255722|NCT01373281|B3|Baseline|Total|Total of all reporting groups
255723|NCT01373281|B2|Baseline|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
255724|NCT01373281|B1|Baseline|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
255725|NCT01373281|P2|Participant Flow|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
255726|NCT01373281|P1|Participant Flow|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
255727|NCT01373281|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
255728|NCT01373281|O1|Outcome|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
255729|NCT01373281|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
255730|NCT01373281|O1|Outcome|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
255731|NCT01373281|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
255732|NCT01373281|O1|Outcome|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
255733|NCT01373281|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
255734|NCT01373281|O1|Outcome|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
255735|NCT01373281|O2|Outcome|Placebo Group|Subset of subjects who received at least one dose of the placebo vaccine.
255736|NCT01373281|O1|Outcome|CYD Dengue Vaccine Group|Subset of subjects who received at least one dose of CYD Dengue vaccine.
255737|NCT01373281|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
255738|NCT01373281|O1|Outcome|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
255739|NCT01373281|E2|Reported Event|Placebo Group|Safety data were collected in subjects that received at least 1 dose of placebo vaccine.
255740|NCT01373281|E1|Reported Event|CYD Dengue Vaccine Group|Safety data were collected in subjects that received at least 1 dose of CYD dengue vaccine.
255741|NCT01373229|B1|Baseline|Lenalidomide + Plerixafor+ Rituximab|"Lenalidomide 5mg by mouth (PO) daily beginning cycle 1 day 1.~Stage 1: increase by 2.5mg every 7 days to a maximum dose of 10mg.~Stage 2: plerixafor will be added after 28 days of 10mg dose maintenance and white blood cell count (WBC) <100.0 x 109 / L.~Dose cohorts of escalating subcutaneous (SC) thrice weekly plerixafor with continuous 10mg lenalidomide:~Cohort 1: 0.24 mg/kg~Cohort 2: 0.32 mg/kg~Stage 3: Rituximab 375mg/m2 will be added on day 1 of cycles 5-12, day 1 of combination therapy for subjects with PR.~Subjects will then continue single agent lenalidomide until disease progression."
255742|NCT01373229|P1|Participant Flow|Lenalidomide + Plerixafor+ Rituximab|"Lenalidomide 5mg by mouth (PO) daily beginning cycle 1 day 1.~Stage 1: increase by 2.5mg every 7 days to a maximum dose of 10mg.~Stage 2: plerixafor will be added after 28 days of 10mg dose maintenance and white blood cell count (WBC) <100.0 x 109 / L.~Dose cohorts of escalating subcutaneous (SC) thrice weekly plerixafor with continuous 10mg lenalidomide:~Cohort 1: 0.24 mg/kg~Cohort 2: 0.32 mg/kg~Stage 3: Rituximab 375mg/m2 will be added on day 1 of cycles 5-12, day 1 of combination therapy for subjects with PR.~Subjects will then continue single agent lenalidomide until disease progression."
255743|NCT01373229|O1|Outcome|Lenalidomide + Plerixafor+ Rituximab|"Lenalidomide 5mg by mouth (PO) daily beginning cycle 1 day 1.~Stage 1: increase by 2.5mg every 7 days to a maximum dose of 10mg.~Stage 2: plerixafor will be added after 28 days of 10mg dose maintenance and white blood cell count (WBC) <100.0 x 109 / L.~Dose cohorts of escalating subcutaneous (SC) thrice weekly plerixafor with continuous 10mg lenalidomide:~Cohort 1: 0.24 mg/kg~Cohort 2: 0.32 mg/kg~Stage 3: Rituximab 375mg/m2 will be added on day 1 of cycles 5-12, day 1 of combination therapy for subjects with PR.~Subjects will then continue single agent lenalidomide until disease progression."
255744|NCT01373229|O1|Outcome|Lenalidomide + Plerixafor+ Rituximab|"Lenalidomide 5mg by mouth (PO) daily beginning cycle 1 day 1.~Stage 1: increase by 2.5mg every 7 days to a maximum dose of 10mg.~Stage 2: plerixafor will be added after 28 days of 10mg dose maintenance and white blood cell count (WBC) <100.0 x 109 / L.~Dose cohorts of escalating subcutaneous (SC) thrice weekly plerixafor with continuous 10mg lenalidomide:~Cohort 1: 0.24 mg/kg~Cohort 2: 0.32 mg/kg~Stage 3: Rituximab 375mg/m2 will be added on day 1 of cycles 5-12, day 1 of combination therapy for subjects with PR.~Subjects will then continue single agent lenalidomide until disease progression."
255745|NCT01373229|O1|Outcome|Lenalidomide + Plerixafor+ Rituximab|"Lenalidomide 5mg by mouth (PO) daily beginning cycle 1 day 1.~Stage 1: increase by 2.5mg every 7 days to a maximum dose of 10mg.~Stage 2: plerixafor will be added after 28 days of 10mg dose maintenance and white blood cell count (WBC) <100.0 x 109 / L.~Dose cohorts of escalating subcutaneous (SC) thrice weekly plerixafor with continuous 10mg lenalidomide:~Cohort 1: 0.24 mg/kg~Cohort 2: 0.32 mg/kg~Stage 3: Rituximab 375mg/m2 will be added on day 1 of cycles 5-12, day 1 of combination therapy for subjects with PR.~Subjects will then continue single agent lenalidomide until disease progression."
255746|NCT01373229|O1|Outcome|Lenalidomide + Plerixafor+ Rituximab|"Lenalidomide 5mg by mouth (PO) daily beginning cycle 1 day 1.~Stage 1: increase by 2.5mg every 7 days to a maximum dose of 10mg.~Stage 2: plerixafor will be added after 28 days of 10mg dose maintenance and white blood cell count (WBC) <100.0 x 109 / L.~Dose cohorts of escalating subcutaneous (SC) thrice weekly plerixafor with continuous 10mg lenalidomide:~Cohort 1: 0.24 mg/kg~Cohort 2: 0.32 mg/kg~Stage 3: Rituximab 375mg/m2 will be added on day 1 of cycles 5-12, day 1 of combination therapy for subjects with PR.~Subjects will then continue single agent lenalidomide until disease progression."
255747|NCT01373229|O1|Outcome|Lenalidomide + Plerixafor+ Rituximab|"Lenalidomide 5mg by mouth (PO) daily beginning cycle 1 day 1.~Stage 1: increase by 2.5mg every 7 days to a maximum dose of 10mg.~Stage 2: plerixafor will be added after 28 days of 10mg dose maintenance and white blood cell count (WBC) <100.0 x 109 / L.~Dose cohorts of escalating subcutaneous (SC) thrice weekly plerixafor with continuous 10mg lenalidomide:~Cohort 1: 0.24 mg/kg~Cohort 2: 0.32 mg/kg~Stage 3: Rituximab 375mg/m2 will be added on day 1 of cycles 5-12, day 1 of combination therapy for subjects with PR.~Subjects will then continue single agent lenalidomide until disease progression."
255748|NCT01373229|O1|Outcome|Lenalidomide + Plerixafor+ Rituximab|"Lenalidomide 5mg by mouth (PO) daily beginning cycle 1 day 1.~Stage 1: increase by 2.5mg every 7 days to a maximum dose of 10mg.~Stage 2: plerixafor will be added after 28 days of 10mg dose maintenance and white blood cell count (WBC) <100.0 x 109 / L.~Dose cohorts of escalating subcutaneous (SC) thrice weekly plerixafor with continuous 10mg lenalidomide:~Cohort 1: 0.24 mg/kg~Cohort 2: 0.32 mg/kg~Stage 3: Rituximab 375mg/m2 will be added on day 1 of cycles 5-12, day 1 of combination therapy for subjects with PR.~Subjects will then continue single agent lenalidomide until disease progression."
255749|NCT01373229|E1|Reported Event|Lenalidomide + Plerixafor+ Rituximab|"Lenalidomide 5mg by mouth (PO) daily beginning cycle 1 day 1.~Stage 1: increase by 2.5mg every 7 days to a maximum dose of 10mg.~Stage 2: plerixafor will be added after 28 days of 10mg dose maintenance and white blood cell count (WBC) <100.0 x 109 / L.~Dose cohorts of escalating subcutaneous (SC) thrice weekly plerixafor with continuous 10mg lenalidomide:~Cohort 1: 0.24 mg/kg~Cohort 2: 0.32 mg/kg~Stage 3: Rituximab 375mg/m2 will be added on day 1 of cycles 5-12, day 1 of combination therapy for subjects with PR.~Subjects will then continue single agent lenalidomide until disease progression."
255750|NCT01373164|B6|Baseline|Total|Total of all reporting groups
255751|NCT01373164|B5|Baseline|Phase 2: Placebo + Gemcitabine|"Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks. participants may continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met."
255752|NCT01373164|B4|Baseline|Phase 2: 300 mg Galunisertib + Gemcitabine|"Galunisertib recommended dose (300 mg) determined from phase 1, administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255753|NCT01373164|B3|Baseline|Phase 1b: 300 mg Galunisertib + Gemcitabine|"Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255754|NCT01373164|B2|Baseline|Phase 1b: 160 mg Galunisertib + Gemcitabine|"Cohort 2: 80 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255755|NCT01373164|B1|Baseline|Phase 1b: 80 mg Galunisertib + Gemcitabine|"Cohort 1: 40 mg Galunisertib was administered orally twice daily (BID) for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255756|NCT01373164|P5|Participant Flow|Phase 2: Placebo + Gemcitabine|"Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255757|NCT01373164|P4|Participant Flow|Phase 2: 300 mg Galunisertib + Gemcitabine|"Galunisertib recommended dose (300 mg) determined from phase 1, administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255809|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
255758|NCT01373164|P3|Participant Flow|Phase 1b: 300 mg Galunisertib + Gemcitabine|"Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255759|NCT01373164|P2|Participant Flow|Phase 1b: 160 mg Galunisertib + Gemcitabine|"Cohort 2: 80 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255760|NCT01373164|P1|Participant Flow|Phase 1b: 80 mg (Milligrams) Galunisertib + Gemcitabine|"Cohort 1: 40 mg Galunisertib was administered orally twice daily (BID) for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 (milligrams per square meter) was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255761|NCT01373164|O2|Outcome|Phase 2: Placebo + Gemcitabine|"Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255762|NCT01373164|O1|Outcome|Phase 2: 300 mg Galunisertib + Gemcitabine|"Galunisertib recommended dose (300 mg) determined from phase 1, administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255763|NCT01373164|O2|Outcome|Placebo+Gemcitabine|"Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255764|NCT01373164|O1|Outcome|Phase 2: 300 mg Galunisertib + Gemcitabine|"Galunisertib recommended dose (300 mg) determined from phase 1, administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255765|NCT01373164|O1|Outcome|Phase 2: 300 mg Galunisertib + Gemcitabine|"Galunisertib recommended dose (300 mg) determined from phase 1, administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255766|NCT01373164|O1|Outcome|Phase 2: 300 mg Galunisertib + Gemcitabine|"Galunisertib recommended dose (300 mg) determined from phase 1, administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255767|NCT01373164|O2|Outcome|Phase 2: Placebo + Gemcitabine|"Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255768|NCT01373164|O1|Outcome|Phase 2: 300 mg Galunisertib + Gemcitabine|"Galunisertib recommended dose (300 mg) determined from phase 1, administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255769|NCT01373164|O2|Outcome|Phase 2: Placebo + Gemcitabine|"Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255770|NCT01373164|O1|Outcome|Phase 2: 300 mg Galunisertib + Gemcitabine|"Galunisertib recommended dose (300 mg) determined from phase 1, administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255771|NCT01373164|O2|Outcome|Phase 2: Placebo + Gemcitabine|"Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255772|NCT01373164|O1|Outcome|Phase 2: 300 mg Galunisertib + Gemcitabine|"Galunisertib recommended dose (300 mg) determined from phase 1, administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255773|NCT01373164|O3|Outcome|Phase 1b: 300 mg Galunisertib + Gemcitabine|"Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255774|NCT01373164|O2|Outcome|Phase 1b: 160 mg Galunisertib + Gemcitabine|"Cohort 2: 80 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255775|NCT01373164|O1|Outcome|Phase 1b: 80 mg Galunisertib + Gemcitabine|"Cohort 1: 40 mg Galunisertib was administered orally twice daily (BID) for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255776|NCT01373164|O3|Outcome|Phase 1b: 300 mg Galunisertib + Gemcitabine|"Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255777|NCT01373164|O2|Outcome|Phase 1b: 160 mg Galunisertib + Gemcitabine|"Cohort 2: 80 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255778|NCT01373164|O1|Outcome|Phase 1b: 80 mg Galunisertib + Gemcitabine|"Cohort 1: 40 mg Galunisertib was administered orally twice daily (BID) for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255779|NCT01373164|O3|Outcome|Phase 1b: 300 mg Galunisertib + Gemcitabine|"Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255780|NCT01373164|O2|Outcome|Phase 1b: 160 mg Galunisertib + Gemcitabine|"Cohort 2: 80 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255781|NCT01373164|O1|Outcome|Phase 1b: 80 mg Galunisertib + Gemcitabine|"Cohort 1: 40 mg Galunisertib was administered orally twice daily (BID) for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255782|NCT01373164|O2|Outcome|Phase 2: Placebo + Gemcitabine|"Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks. Participant's may continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met."
255783|NCT01373164|O1|Outcome|Phase 2: 300 mg Galunisertib + Gemcitabine|"Galunisertib recommended dose (300 mg) determined from phase 1, administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255784|NCT01373164|O1|Outcome|Phase 1b Participants|Participants received galunisertib at a starting dose of 80 mg/day in combination with gemcitabine. Dose escalation proceeded in cohorts of between 3 to 6 evaluable participants until ≥2 participants experienced a dose limiting toxicity (DLT) or an galunisertib dose level of 300 mg/day was reached.
255785|NCT01373164|E5|Reported Event|Phase 2: Placebo + Gemcitabine|"Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255786|NCT01373164|E4|Reported Event|Phase 2: 300 mg Galunisertib + Gemcitabine|"Galunisertib recommended dose (300 mg) determined from phase 1, administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255787|NCT01373164|E3|Reported Event|Phase 1b: 300 mg Galunisertib + Gemcitabine|"Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255788|NCT01373164|E2|Reported Event|Phase 1b: 160 mg Galunisertib + Gemcitabine|"Cohort 2: 80 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255789|NCT01373164|E1|Reported Event|Phase 1b: 80 mg Galunisertib + Gemcitabine|"Cohort 1: 40 mg Galunisertib was administered orally twice daily (BID) for 14 days followed by 14 days of rest (28 day cycle).~Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks."
255790|NCT01372995|B4|Baseline|Total|Total of all reporting groups
255791|NCT01372995|B3|Baseline|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
255792|NCT01372995|B2|Baseline|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
255793|NCT01372995|B1|Baseline|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
255794|NCT01372995|P3|Participant Flow|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
255795|NCT01372995|P2|Participant Flow|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
255796|NCT01372995|P1|Participant Flow|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
255797|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
255798|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
255799|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
255800|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
255801|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
255802|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
255803|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
255804|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
255805|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
269078|NCT01333397|O4|Outcome|Dysport NG 75 U|
255810|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
255811|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
255812|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
255813|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
255814|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
255815|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
255816|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
255817|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
255818|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
255819|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
255820|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
255821|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
255822|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
255823|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
255824|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
255825|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
255826|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
255827|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
255828|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
255829|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
255830|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
255831|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
255832|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
255833|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
255834|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
255835|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
255836|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
255837|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
255838|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
255839|NCT01372995|E3|Reported Event|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally.
255840|NCT01372995|E2|Reported Event|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally.
255841|NCT01372995|E1|Reported Event|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
255842|NCT01372878|B1|Baseline|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison"
255843|NCT01372878|P1|Participant Flow|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison"
255844|NCT01372878|O1|Outcome|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison"
255845|NCT01372878|O1|Outcome|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison"
255863|NCT01372748|P2|Participant Flow|Continuous Chest Compressions|"Continuous compression CPR~Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation."
269079|NCT01333397|O3|Outcome|Dysport NG 50 U|
255846|NCT01372878|E1|Reported Event|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison"
255847|NCT01372813|B1|Baseline|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
255848|NCT01372813|P1|Participant Flow|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
255849|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
255850|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
255851|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
255852|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
255853|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
255854|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
255855|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
255856|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
255857|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
255858|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
255859|NCT01372813|E1|Reported Event|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
255860|NCT01372748|B3|Baseline|Total|Total of all reporting groups
255861|NCT01372748|B2|Baseline|Continuous Chest Compressions|"Continuous compression CPR~Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation."
255862|NCT01372748|B1|Baseline|Standard CPR|"American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations~Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first."
255864|NCT01372748|P1|Participant Flow|Standard CPR|"American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations~Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first."
255865|NCT01372748|O2|Outcome|Continuous Chest Compressions|"Continuous compression CPR~Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation."
255866|NCT01372748|O1|Outcome|Standard CPR|"American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations~Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first."
255867|NCT01372748|O2|Outcome|Continuous Chest Compressions|"Continuous compression CPR~Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation."
255868|NCT01372748|O1|Outcome|Standard CPR|"American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations~Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first."
255869|NCT01372748|E2|Reported Event|Continuous Chest Compressions|"Continuous compression CPR~Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation."
255870|NCT01372748|E1|Reported Event|Standard CPR|"American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations~Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first."
255871|NCT01372618|B1|Baseline|SOM 230/Pasireotide|"Treatment with SOM230 600mcg twice daily for 20 days.~SOM 230 / Pasireotide: SOM230/Pasireotide is a multi-receptor targeted somatostatin analogue. In this trial, 600 mcg of SOM230/Pasireotide are taken twice daily subcutaneously."
255872|NCT01372618|P1|Participant Flow|SOM 230/Pasireotide|"Treatment with SOM230 600mcg twice daily for 20 days.~SOM 230 / Pasireotide: SOM230/Pasireotide is a multi-receptor targeted somatostatin analogue. In this trial, 600 mcg of SOM230/Pasireotide are taken twice daily subcutaneously."
255873|NCT01372618|O1|Outcome|SOM 230/Pasireotide|"Treatment with SOM230 600mcg twice daily for 20 days.~SOM 230 / Pasireotide: SOM230/Pasireotide is a multi-receptor targeted somatostatin analogue. In this trial, 600 mcg of SOM230/Pasireotide are taken twice daily subcutaneously."
255874|NCT01372618|O1|Outcome|SOM 230/Pasireotide|"Treatment with SOM230 600mcg twice daily for 20 days.~SOM 230 / Pasireotide: SOM230/Pasireotide is a multi-receptor targeted somatostatin analogue. In this trial, 600 mcg of SOM230/Pasireotide are taken twice daily subcutaneously."
255875|NCT01372618|O1|Outcome|SOM 230/Pasireotide|"Treatment with SOM230 600mcg twice daily for 20 days.~SOM 230 / Pasireotide: SOM230/Pasireotide is a multi-receptor targeted somatostatin analogue. In this trial, 600 mcg of SOM230/Pasireotide are taken twice daily subcutaneously."
255876|NCT01372618|E1|Reported Event|SOM 230/Pasireotide|"Treatment with SOM230 600mcg twice daily for 20 days.~SOM 230 / Pasireotide: SOM230/Pasireotide is a multi-receptor targeted somatostatin analogue. In this trial, 600 mcg of SOM230/Pasireotide are taken twice daily subcutaneously."
255877|NCT01372605|B3|Baseline|Total|Total of all reporting groups
255878|NCT01372605|B2|Baseline|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
255879|NCT01372605|B1|Baseline|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
255880|NCT01372605|P2|Participant Flow|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
255881|NCT01372605|P1|Participant Flow|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
255882|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
255883|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
255884|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
255885|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
255886|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
255887|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
255888|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
255889|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
255890|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
255891|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
255892|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
255893|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
255894|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
255895|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
255896|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
255897|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
255898|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
255899|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
255900|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
255901|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
255902|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
255903|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
255904|NCT01372605|E2|Reported Event|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
261074|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
255905|NCT01372605|E1|Reported Event|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
255906|NCT01372501|B1|Baseline|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
255907|NCT01372501|P1|Participant Flow|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device.~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
255908|NCT01372501|O1|Outcome|EndoBarrier Liner Device|Endobarrier Liner: Medical device placed endoscopically in the duodenum
255909|NCT01372501|O1|Outcome|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
255910|NCT01372501|E1|Reported Event|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
255911|NCT01372462|B1|Baseline|Overall Study Group|Crossover design. Subject were randomized to complete all 4 study arms: 1) NIOV - Oxygen, 2) NIOV - Room Air, 3) Oxygen Nasal Cannula, 4) No treatment
255912|NCT01372462|P1|Participant Flow|All Study Participants|"All subjects completed all 4 visit days in which they were randomized to receive which treatment to receive first: 1) NIOV - Oxygen, 2) NIOV - Room Air, 3) Oxygen Nasal Cannula, 4) No treatment.~Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and Nasal Cannula Oxygen."
255913|NCT01372462|O4|Outcome|No Treatment|Control arm. Subjects exercise without using supplemental oxygen or NIOV.
255914|NCT01372462|O3|Outcome|Nasal Cannula Oxygen|"Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).~Nasal Cannula Oxygen: Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen."
255915|NCT01372462|O2|Outcome|NIOV - Oxygen|"Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).~NIOV - Oxygen: Noninvasive ventilation with device powered by compressed medical (100%) oxygen."
255916|NCT01372462|O1|Outcome|NIOV - Room Air|"Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).~NIOV - Room Air: Noninvasive ventilation with device powered by compressed room air."
255917|NCT01372462|O4|Outcome|No Treatment|Control arm. Subjects exercise without using supplemental oxygen or NIOV.
255918|NCT01372462|O3|Outcome|Nasal Cannula Oxygen|"Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).~Nasal Cannula Oxygen: Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen."
255919|NCT01372462|O2|Outcome|NIOV - Oxygen|"Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).~NIOV - Oxygen: Noninvasive ventilation with device powered by compressed medical (100%) oxygen."
255920|NCT01372462|O1|Outcome|NIOV - Room Air|"Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).~NIOV - Room Air: Noninvasive ventilation with device powered by compressed room air."
255921|NCT01372462|O4|Outcome|No Treatment|Control arm. Subjects exercise without using supplemental oxygen or NIOV.
255922|NCT01372462|O3|Outcome|Nasal Cannula Oxygen|"Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).~Nasal Cannula Oxygen: Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen."
255923|NCT01372462|O2|Outcome|NIOV - Oxygen|"Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).~NIOV - Oxygen: Noninvasive ventilation with device powered by compressed medical (100%) oxygen."
255924|NCT01372462|O1|Outcome|NIOV - Room Air|"Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).~NIOV - Room Air: Noninvasive ventilation with device powered by compressed room air."
255925|NCT01372462|E4|Reported Event|No Treatment|Control arm. Subjects exercise without using supplemental oxygen or NIOV.
255926|NCT01372462|E3|Reported Event|Nasal Cannula Oxygen|"Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).~Nasal Cannula Oxygen: Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen."
255927|NCT01372462|E2|Reported Event|NIOV - Oxygen|"Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).~NIOV - Oxygen: Noninvasive ventilation with device powered by compressed medical (100%) oxygen."
255928|NCT01372462|E1|Reported Event|NIOV - Room Air|"Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).~NIOV - Room Air: Noninvasive ventilation with device powered by compressed room air."
255929|NCT01372410|B1|Baseline|All Study Treatments|Participants received a sequence containing 3 of the following 8 possible treatments: placebo; UMEC 15.6 µg, 31.25 µg, 62.5 µg, and 125 µg QD; UMEC 15.6 µg and 31.25 µg BID; TIO 18 µg QD. Participants received each of the treatments in 1 of 3 7-day treatment periods, each of which was followed by a Washout Period. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255930|NCT01372410|P8|Participant Flow|TIO 18 µg QD|Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255931|NCT01372410|P7|Participant Flow|UMEC 31.25 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255932|NCT01372410|P6|Participant Flow|UMEC 15.6 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255933|NCT01372410|P5|Participant Flow|UMEC 125 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255934|NCT01372410|P4|Participant Flow|UMEC 62.5 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255935|NCT01372410|P3|Participant Flow|UMEC 31.25 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255936|NCT01372410|P2|Participant Flow|UMEC 15.6 µg QD|Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255937|NCT01372410|P1|Participant Flow|Placebo|Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255938|NCT01372410|O8|Outcome|TIO 18 µg QD|Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255939|NCT01372410|O7|Outcome|UMEC 31.25 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255940|NCT01372410|O6|Outcome|UMEC 15.6 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255941|NCT01372410|O5|Outcome|UMEC 125 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255942|NCT01372410|O4|Outcome|UMEC 62.5 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255943|NCT01372410|O3|Outcome|UMEC 31.25 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255944|NCT01372410|O2|Outcome|UMEC 15.6 µg QD|Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255945|NCT01372410|O1|Outcome|Placebo|Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255946|NCT01372410|O1|Outcome|All Study Treatments|Participants received a sequence containing 3 of the following 8 possible treatments: placebo; UMEC 15.6 µg, 31.25 µg, 62.5 µg, and 125 µg QD; UMEC 15.6 µg and 31.25 µg BID; TIO 18 µg QD. Participants received each of the treatments in 1 of 3 7-day treatment periods, each of which was followed by a Washout Period. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255947|NCT01372410|O1|Outcome|All Study Treatments|Participants received a sequence containing 3 of the following 8 possible treatments: placebo; UMEC 15.6 µg, 31.25 µg, 62.5 µg, and 125 µg QD; UMEC 15.6 µg and 31.25 µg BID; TIO 18 µg QD. Participants received each of the treatments in 1 of 3 7-day treatment periods, each of which was followed by a Washout Period. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255948|NCT01372410|O8|Outcome|TIO 18 µg QD|Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255949|NCT01372410|O7|Outcome|UMEC 31.25 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255950|NCT01372410|O6|Outcome|UMEC 15.6 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255951|NCT01372410|O5|Outcome|UMEC 125 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255952|NCT01372410|O4|Outcome|UMEC 62.5 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255953|NCT01372410|O3|Outcome|UMEC 31.25 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255954|NCT01372410|O2|Outcome|UMEC 15.6 µg QD|Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255955|NCT01372410|O1|Outcome|Placebo|Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255956|NCT01372410|O8|Outcome|TIO 18 µg QD|Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255957|NCT01372410|O7|Outcome|UMEC 31.25 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255958|NCT01372410|O6|Outcome|UMEC 15.6 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255959|NCT01372410|O5|Outcome|UMEC 125 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255960|NCT01372410|O4|Outcome|UMEC 62.5 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255961|NCT01372410|O3|Outcome|UMEC 31.25 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255962|NCT01372410|O2|Outcome|UMEC 15.6 µg QD|Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255963|NCT01372410|O1|Outcome|Placebo|Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255964|NCT01372410|O1|Outcome|All Study Treatments|Participants received a sequence containing 3 of the following 8 possible treatments: placebo; UMEC 15.6 µg, 31.25 µg, 62.5 µg, and 125 µg QD; UMEC 15.6 µg and 31.25 µg BID; TIO 18 µg QD. Participants received each of the treatments in 1 of 3 7-day treatment periods, each of which was followed by a Washout Period. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255965|NCT01372410|E8|Reported Event|TIO 18 µg QD|Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255966|NCT01372410|E7|Reported Event|UMEC 31.25 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
256031|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
255967|NCT01372410|E6|Reported Event|UMEC 15.6 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255968|NCT01372410|E5|Reported Event|UMEC 125 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255969|NCT01372410|E4|Reported Event|UMEC 62.5 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255970|NCT01372410|E3|Reported Event|UMEC 31.25 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255971|NCT01372410|E2|Reported Event|UMEC 15.6 µg QD|Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255972|NCT01372410|E1|Reported Event|Placebo|Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
255973|NCT01372384|B1|Baseline|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
255974|NCT01372384|P1|Participant Flow|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
255975|NCT01372384|O1|Outcome|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
255976|NCT01372384|O1|Outcome|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
255977|NCT01372384|O1|Outcome|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
255978|NCT01372384|O1|Outcome|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
255979|NCT01372384|E1|Reported Event|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
255980|NCT01372202|B4|Baseline|Total|Total of all reporting groups
255981|NCT01372202|B3|Baseline|Arm C|Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
255982|NCT01372202|B2|Baseline|Arm B|"Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy~Cisplatin: Paclitaxel and cisplatin:~Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.~Cisplatin and 5-fluorouracil:~5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.~Cisplatin 75 mg/m² days 1, 29.~Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.~5-Fu: Oxaliplatin & 5-fu:~Oxaliplatin 85 mg/m2 days 1, 15, 29.~5-Fu 180 mg/m2 prolonged infusion day 1 of radiation & completing on the final day of radiation~Cisplatin/5-fluorouracil:~5-Fu 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.~Cisplatin 75 mg/m² days 1, 29.~Radiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy."
255983|NCT01372202|B1|Baseline|Arm A|"Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy~Paclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin: Paclitaxel and cisplatin:~Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.~Cisplatin and 5-fluorouracil:~5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.~Cisplatin 75 mg/m² days 1, 29.~Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.~Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 – 56)."
255984|NCT01372202|P3|Participant Flow|Cisplatin With 5 Fu|Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
255985|NCT01372202|P2|Participant Flow|Arm B|"Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy~Cisplatin: Paclitaxel and cisplatin:~Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.~Cisplatin and 5-fluorouracil:~5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.~Cisplatin 75 mg/m² days 1, 29.~Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.~5-Fu: Oxaliplatin & 5-fu:~Oxaliplatin 85 mg/m2 days 1, 15, 29.~5-Fu 180 mg/m2 prolonged infusion day 1 of radiation & completing on the final day of radiation~Cisplatin/5-fluorouracil:~5-Fu 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.~Cisplatin 75 mg/m² days 1, 29.~Radiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy."
256068|NCT01371877|O1|Outcome|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.~Vitamin D: Vitamin D 4000 IU per day for 3 months"
255986|NCT01372202|P1|Participant Flow|Arm A|"Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy~Paclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin: Paclitaxel and cisplatin:~Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.~Cisplatin and 5-fluorouracil:~5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.~Cisplatin 75 mg/m² days 1, 29.~Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.~Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 – 56)."
255987|NCT01372202|O3|Outcome|Arm C|Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
255988|NCT01372202|O2|Outcome|Arm B|"Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy~Cisplatin: Paclitaxel and cisplatin:~Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.~Cisplatin and 5-fluorouracil:~5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.~Cisplatin 75 mg/m² days 1, 29.~Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.~5-Fu: Oxaliplatin & 5-fu:~Oxaliplatin 85 mg/m2 days 1, 15, 29.~5-Fu 180 mg/m2 prolonged infusion day 1 of radiation & completing on the final day of radiation~Cisplatin/5-fluorouracil:~5-Fu 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.~Cisplatin 75 mg/m² days 1, 29.~Radiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy."
255989|NCT01372202|O1|Outcome|Arm A|"Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy~Paclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin: Paclitaxel and cisplatin:~Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.~Cisplatin and 5-fluorouracil:~5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.~Cisplatin 75 mg/m² days 1, 29.~Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.~Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 – 56)."
255990|NCT01372202|E3|Reported Event|Cisplatin With 5 Fu|Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
255991|NCT01372202|E2|Reported Event|Arm B|"Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy~Cisplatin: Paclitaxel and cisplatin:~Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.~Cisplatin and 5-fluorouracil:~5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.~Cisplatin 75 mg/m² days 1, 29.~Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.~5-Fu: Oxaliplatin & 5-fu:~Oxaliplatin 85 mg/m2 days 1, 15, 29.~5-Fu 180 mg/m2 prolonged infusion day 1 of radiation & completing on the final day of radiation~Cisplatin/5-fluorouracil:~5-Fu 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.~Cisplatin 75 mg/m² days 1, 29.~Radiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy."
255992|NCT01372202|E1|Reported Event|Arm A|"Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy~Paclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin: Paclitaxel and cisplatin:~Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.~Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.~Cisplatin and 5-fluorouracil:~5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.~Cisplatin 75 mg/m² days 1, 29.~Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.~Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 – 56)."
255993|NCT01372150|B4|Baseline|Total|Total of all reporting groups
255994|NCT01372150|B3|Baseline|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
255995|NCT01372150|B2|Baseline|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
255996|NCT01372150|B1|Baseline|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
255997|NCT01372150|P3|Participant Flow|Desvenlafaxine Succinate Sustained Release (DVS SR)|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
255998|NCT01372150|P2|Participant Flow|Fluoxetine|Fluoxetine capsules 10 (milligram) mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily as appropriate for 1 week (taper/transition phase).
255999|NCT01372150|P1|Participant Flow|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
256000|NCT01372150|O3|Outcome|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
256001|NCT01372150|O2|Outcome|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
256002|NCT01372150|O1|Outcome|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
256069|NCT01371877|O2|Outcome|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.~Vitamin D: Vitamin D 600 IU per day"
256003|NCT01372150|O3|Outcome|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
256004|NCT01372150|O2|Outcome|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
256005|NCT01372150|O1|Outcome|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
256006|NCT01372150|O3|Outcome|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
256007|NCT01372150|O2|Outcome|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
256008|NCT01372150|O1|Outcome|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
256009|NCT01372150|O3|Outcome|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
256010|NCT01372150|O2|Outcome|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
256011|NCT01372150|O1|Outcome|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
256012|NCT01372150|E3|Reported Event|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
256013|NCT01372150|E2|Reported Event|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
256014|NCT01372150|E1|Reported Event|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
256015|NCT01371994|B3|Baseline|Total|Total of all reporting groups
256016|NCT01371994|B2|Baseline|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
256017|NCT01371994|B1|Baseline|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
256018|NCT01371994|P2|Participant Flow|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
256019|NCT01371994|P1|Participant Flow|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
256020|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
256021|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
256022|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
256023|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
256024|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
256025|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
256026|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
256027|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
256028|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
256029|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
256030|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
256032|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
256033|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
256034|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
256035|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
256036|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
256037|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
256038|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
256039|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
256040|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
256041|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
256042|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
256043|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
256044|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
256045|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
256046|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
256047|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
256048|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
256049|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
256050|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
256051|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
256052|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
256053|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
256054|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
256055|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
256056|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
256057|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
256058|NCT01371994|E2|Reported Event|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
256059|NCT01371994|E1|Reported Event|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
256060|NCT01371877|B3|Baseline|Total|Total of all reporting groups
256061|NCT01371877|B2|Baseline|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.~Vitamin D: Vitamin D 600 IU per day"
256062|NCT01371877|B1|Baseline|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.~Vitamin D: Vitamin D 4000 IU per day for 3 months"
256063|NCT01371877|P2|Participant Flow|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.~Vitamin D: Vitamin D 600 IU per day"
256064|NCT01371877|P1|Participant Flow|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.~Vitamin D: Vitamin D 4000 IU per day for 3 months"
256065|NCT01371877|O2|Outcome|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.~Vitamin D: Vitamin D 600 IU per day"
256066|NCT01371877|O1|Outcome|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.~Vitamin D: Vitamin D 4000 IU per day for 3 months"
256067|NCT01371877|O2|Outcome|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.~Vitamin D: Vitamin D 600 IU per day"
269080|NCT01333397|O2|Outcome|Dysport NG 20 U|
256070|NCT01371877|O1|Outcome|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.~Vitamin D: Vitamin D 4000 IU per day for 3 months"
256071|NCT01371877|E2|Reported Event|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.~Vitamin D: Vitamin D 600 IU per day"
256072|NCT01371877|E1|Reported Event|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.~Vitamin D: Vitamin D 4000 IU per day for 3 months"
256073|NCT01371851|B3|Baseline|Total|Total of all reporting groups
256074|NCT01371851|B2|Baseline|Placebo|"Participants will be maintained on placebo (cellulose) throughout the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
256075|NCT01371851|B1|Baseline|Doxazosin|"Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
256076|NCT01371851|P2|Participant Flow|Placebo|"Participants will be maintained on placebo (cellulose) throughout the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
256077|NCT01371851|P1|Participant Flow|Doxazosin|"Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
256078|NCT01371851|O2|Outcome|Placebo|"Participants will be maintained on placebo (cellulose) throughout the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
256079|NCT01371851|O1|Outcome|Doxazosin|"Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
256080|NCT01371851|E2|Reported Event|Placebo|"Participants will be maintained on placebo (cellulose) throughout the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
256081|NCT01371851|E1|Reported Event|Doxazosin|"Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
256082|NCT01371838|B3|Baseline|Total|Total of all reporting groups
256083|NCT01371838|B2|Baseline|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
256084|NCT01371838|B1|Baseline|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
256085|NCT01371838|P2|Participant Flow|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
256086|NCT01371838|P1|Participant Flow|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
256087|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
256088|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
256089|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
256090|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
256091|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
256092|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
256093|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
256094|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
256095|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
256096|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
256097|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
256098|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
256099|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
256100|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
256101|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
256102|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
256103|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
256104|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
256105|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
256106|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
256107|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
256108|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
256109|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
256110|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
256111|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
256112|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
256113|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
256114|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
256115|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
256116|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
256117|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
256118|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
256119|NCT01371838|E2|Reported Event|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
256120|NCT01371838|E1|Reported Event|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
256121|NCT01371825|B1|Baseline|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
256122|NCT01371825|P1|Participant Flow|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
256123|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
256124|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
256125|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
256145|NCT01371786|O1|Outcome|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
256146|NCT01371786|O2|Outcome|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
256147|NCT01371786|O1|Outcome|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
261075|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
256126|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
256127|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
256128|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
256129|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
256130|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
256131|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
256132|NCT01371825|E1|Reported Event|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
256133|NCT01371786|B3|Baseline|Total|Total of all reporting groups
256134|NCT01371786|B2|Baseline|Sequence Mometasone Aqueous / Ciclesonide Nasal Aerosol|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle followed by a washout period of 120 hours and a radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canistermometasone Aqueous (AQ) nasal spray : A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
256135|NCT01371786|B1|Baseline|Sequence Ciclesonide Nasal Aerosol /Mometsasone Aqueous|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister followed by a washout period of 120 hours and a radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
256136|NCT01371786|P2|Participant Flow|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle followed by a washout period of 120 hours and a radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
256137|NCT01371786|P1|Participant Flow|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister followed by a washout period of 120 hours and a radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
256138|NCT01371786|O2|Outcome|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
256139|NCT01371786|O1|Outcome|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
256140|NCT01371786|O2|Outcome|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
256141|NCT01371786|O1|Outcome|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
256142|NCT01371786|O2|Outcome|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
256143|NCT01371786|O1|Outcome|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
256144|NCT01371786|O2|Outcome|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
256149|NCT01371786|E1|Reported Event|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
256150|NCT01371747|B7|Baseline|Total|Total of all reporting groups
256151|NCT01371747|B6|Baseline|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
256152|NCT01371747|B5|Baseline|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day
256153|NCT01371747|B4|Baseline|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
256154|NCT01371747|B3|Baseline|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
256155|NCT01371747|B2|Baseline|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
256156|NCT01371747|B1|Baseline|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
256157|NCT01371747|P6|Participant Flow|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
256158|NCT01371747|P5|Participant Flow|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
256159|NCT01371747|P4|Participant Flow|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
256160|NCT01371747|P3|Participant Flow|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
256161|NCT01371747|P2|Participant Flow|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
256162|NCT01371747|P1|Participant Flow|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
256163|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
256164|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
256165|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
256166|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
256167|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
256168|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
256169|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
256170|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
256171|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
256172|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
256173|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
256174|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day
256175|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
256176|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
256177|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
256178|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
256179|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
256180|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
256181|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
256182|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
256183|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
256184|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
256185|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
256186|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
256187|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
256188|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
256189|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
256190|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
256191|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
256192|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
256193|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
256194|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
256195|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
256196|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
256197|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
256198|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
256199|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
256200|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
256201|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
256202|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
256203|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
256204|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
256205|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
256206|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
256207|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
256208|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
256209|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
256210|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
256211|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
256212|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
256213|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
256214|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
256215|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
261076|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
256216|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
256217|NCT01371747|E6|Reported Event|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
256218|NCT01371747|E5|Reported Event|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
256219|NCT01371747|E4|Reported Event|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
256220|NCT01371747|E3|Reported Event|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
256221|NCT01371747|E2|Reported Event|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
256222|NCT01371747|E1|Reported Event|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
256223|NCT01371734|B4|Baseline|Total|Total of all reporting groups
256224|NCT01371734|B3|Baseline|DVS SR High Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
256225|NCT01371734|B2|Baseline|DVS SR Low Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
256226|NCT01371734|B1|Baseline|Placebo|Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
256227|NCT01371734|P3|Participant Flow|DVS SR High Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
256228|NCT01371734|P2|Participant Flow|DVS SR Low Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
256229|NCT01371734|P1|Participant Flow|Placebo|Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
256230|NCT01371734|O3|Outcome|DVS SR High Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
256231|NCT01371734|O2|Outcome|DVS SR Low Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
256232|NCT01371734|O1|Outcome|Placebo|Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
256233|NCT01371734|O3|Outcome|DVS SR High Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
256234|NCT01371734|O2|Outcome|DVS SR Low Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
256235|NCT01371734|O1|Outcome|Placebo|Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
256236|NCT01371734|O3|Outcome|DVS SR High Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
256268|NCT01371721|O4|Outcome|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256269|NCT01371721|O3|Outcome|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256237|NCT01371734|O2|Outcome|DVS SR Low Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
256238|NCT01371734|O1|Outcome|Placebo|Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
256239|NCT01371734|O3|Outcome|DVS SR High Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
256240|NCT01371734|O2|Outcome|DVS SR Low Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
256241|NCT01371734|O1|Outcome|Placebo|Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
256242|NCT01371734|E3|Reported Event|DVS SR High Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
256243|NCT01371734|E2|Reported Event|DVS SR Low Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
256244|NCT01371734|E1|Reported Event|Placebo|Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
256245|NCT01371721|B4|Baseline|Total|Total of all reporting groups
256246|NCT01371721|B3|Baseline|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256247|NCT01371721|B2|Baseline|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256248|NCT01371721|B1|Baseline|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256249|NCT01371721|P3|Participant Flow|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256250|NCT01371721|P2|Participant Flow|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256251|NCT01371721|P1|Participant Flow|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256252|NCT01371721|O4|Outcome|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256253|NCT01371721|O3|Outcome|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256254|NCT01371721|O2|Outcome|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256255|NCT01371721|O1|Outcome|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256256|NCT01371721|O4|Outcome|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256257|NCT01371721|O3|Outcome|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256258|NCT01371721|O2|Outcome|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256259|NCT01371721|O1|Outcome|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256260|NCT01371721|O4|Outcome|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256261|NCT01371721|O3|Outcome|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256262|NCT01371721|O2|Outcome|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256263|NCT01371721|O1|Outcome|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256264|NCT01371721|O4|Outcome|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256265|NCT01371721|O3|Outcome|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256266|NCT01371721|O2|Outcome|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256267|NCT01371721|O1|Outcome|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
269081|NCT01333397|O1|Outcome|Placebo|
256270|NCT01371721|O2|Outcome|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256271|NCT01371721|O1|Outcome|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256272|NCT01371721|O4|Outcome|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256273|NCT01371721|O3|Outcome|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256274|NCT01371721|O2|Outcome|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256275|NCT01371721|O1|Outcome|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256276|NCT01371721|E4|Reported Event|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256277|NCT01371721|E3|Reported Event|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256278|NCT01371721|E2|Reported Event|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256279|NCT01371721|E1|Reported Event|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
256280|NCT01371708|B4|Baseline|Total|Total of all reporting groups
256281|NCT01371708|B3|Baseline|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256282|NCT01371708|B2|Baseline|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256283|NCT01371708|B1|Baseline|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256284|NCT01371708|P3|Participant Flow|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256285|NCT01371708|P2|Participant Flow|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256286|NCT01371708|P1|Participant Flow|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256287|NCT01371708|O1|Outcome|Combination Group|Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
256288|NCT01371708|O3|Outcome|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256289|NCT01371708|O2|Outcome|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256290|NCT01371708|O1|Outcome|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256291|NCT01371708|O1|Outcome|Combination Group|Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
256292|NCT01371708|O3|Outcome|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256293|NCT01371708|O2|Outcome|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256294|NCT01371708|O1|Outcome|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256295|NCT01371708|O1|Outcome|Combination Group|Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
256296|NCT01371708|O3|Outcome|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256297|NCT01371708|O2|Outcome|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256298|NCT01371708|O1|Outcome|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256299|NCT01371708|O1|Outcome|Combination Group|Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
256300|NCT01371708|O3|Outcome|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256301|NCT01371708|O2|Outcome|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256339|NCT01371552|O1|Outcome|Delefilcon A - All Wearers|Delefilcon A contact lenses worn in a daily disposable mode for 7 days in Part 2, all wearers
256302|NCT01371708|O1|Outcome|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256303|NCT01371708|O1|Outcome|Combination Group|Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
256304|NCT01371708|O3|Outcome|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256305|NCT01371708|O2|Outcome|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256306|NCT01371708|O1|Outcome|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256307|NCT01371708|O1|Outcome|Combination Group|Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
256308|NCT01371708|O3|Outcome|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256309|NCT01371708|O2|Outcome|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256310|NCT01371708|O1|Outcome|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256311|NCT01371708|E4|Reported Event|Combination Group|Combination of 3 groups of participants from previous study B2061032 received DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256312|NCT01371708|E3|Reported Event|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256313|NCT01371708|E2|Reported Event|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing(20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256314|NCT01371708|E1|Reported Event|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
256315|NCT01371643|B3|Baseline|Total|Total of all reporting groups
256316|NCT01371643|B2|Baseline|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured~Octreotide LAR~transsphenoidal surgery"
256317|NCT01371643|B1|Baseline|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery~Octreotide LAR"
256318|NCT01371643|P2|Participant Flow|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured~Octreotide LAR~transsphenoidal surgery"
256319|NCT01371643|P1|Participant Flow|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery~Octreotide LAR"
256320|NCT01371643|O2|Outcome|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured~Octreotide LAR~transsphenoidal surgery"
256321|NCT01371643|O1|Outcome|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery~Octreotide LAR"
256322|NCT01371643|O2|Outcome|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured~Octreotide LAR~transsphenoidal surgery"
256323|NCT01371643|O1|Outcome|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery~Octreotide LAR"
256324|NCT01371643|O2|Outcome|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured~Octreotide LAR~transsphenoidal surgery"
256325|NCT01371643|O1|Outcome|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery~Octreotide LAR"
256326|NCT01371643|E2|Reported Event|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured~Octreotide LAR~transsphenoidal surgery"
256327|NCT01371643|E1|Reported Event|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery~Octreotide LAR"
256328|NCT01371565|B1|Baseline|Mifepristone|At doses from 300mg/day up to 1200mg/day
256329|NCT01371565|P1|Participant Flow|Mifepristone|At doses from 300mg/day up to 1200mg/day
256330|NCT01371565|O1|Outcome|Mifepristone|At doses from 300mg/day up to 1200mg/day
256331|NCT01371565|E1|Reported Event|Mifepristone|At doses from 300mg/day up to 1200mg/day
256332|NCT01371552|B1|Baseline|Overall Study|This reporting group includes all enrolled participants.
256333|NCT01371552|P6|Participant Flow|Filcon II 3 / Delefilcon A / Narafilcon A|Part 1: Filcon II 3, then Delefilcon A, then Narafilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
256334|NCT01371552|P5|Participant Flow|Narafilcon A / Delefilcon A / Filcon II 3|Part 1: Narafilcon A, then Delefilcon A, then Filcon II 3, 3 days each. Part 2: Delefilcon A for 1 week.
256335|NCT01371552|P4|Participant Flow|Delefilcon A / Narafilcon A / Filcon II 3|Part 1: Delefilcon A, then Narafilcon A, then Filcon II 3, 3 days each. Part 2: Delefilcon A for 1 week.
256336|NCT01371552|P3|Participant Flow|Filcon II 3 / Narafilcon A / Delefilcon A|Part 1: Filcon II 3, then Narafilcon A, the Delefilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
256337|NCT01371552|P2|Participant Flow|Narafilcon A / Filcon II 3 / Delefilcon A|Part 1: Narafilcon A, then Filcon II 3, then Delefilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
256338|NCT01371552|P1|Participant Flow|Delefilcon A / Filcon II 3 / Narafilcon A|Part 1: Delefilcon A, then Filcon II 3, then Narafilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
256343|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
256344|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
256345|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
256346|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
256347|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
256348|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
256349|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
256350|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
256351|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
256352|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
256353|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
256354|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
256355|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
256356|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
256357|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
256358|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
256359|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
256360|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
256361|NCT01371552|E3|Reported Event|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
256362|NCT01371552|E2|Reported Event|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
256363|NCT01371552|E1|Reported Event|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
256364|NCT01371539|B1|Baseline|Overall|All enrolled and dispensed participants
256365|NCT01371539|P2|Participant Flow|Comfilcon A / Lotrafilcon B|Comfilcon A contact lenses worn first, with lotrafilcon B contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
256366|NCT01371539|P1|Participant Flow|Lotrafilcon B / Comfilcon A|Lotrafilcon B contact lenses worn first, with comfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
256367|NCT01371539|O2|Outcome|Comfilcon A|Comfilcon A contact lenses worn bilaterally on a daily wear basis for one week.
256368|NCT01371539|O1|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn bilaterally on a daily wear basis for one week.
256369|NCT01371539|O2|Outcome|Comfilcon A|Comfilcon A contact lenses worn bilaterally on a daily wear basis for one week.
256370|NCT01371539|O1|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn bilaterally on a daily wear basis for one week.
256371|NCT01371539|E2|Reported Event|Comfilcon A|Comfilcon A contact lenses worn bilaterally on a daily wear basis for one week.
256372|NCT01371539|E1|Reported Event|Lotrafilcon B|Lotrafilcon B contact lenses worn bilaterally on a daily wear basis for one week.
256373|NCT01371110|B3|Baseline|Total|Total of all reporting groups
256374|NCT01371110|B2|Baseline|Midazolam (Randomized Wk 1, Cross Over Ketamine Wk 3)|"Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam~Midazolam: Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant."
256375|NCT01371110|B1|Baseline|Ketamine (Randomized Week 1, Cross Over Midazolam Week 3))|"Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride~Ketamine: Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter."
256376|NCT01371110|P2|Participant Flow|Midazolam (Randomized Wk 1, Cross Over Ketamine Wk 3)|"Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam~Midazolam: Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant."
256377|NCT01371110|P1|Participant Flow|Ketamine (Randomized Week 1, Cross Over Midazolam Week 3))|"Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride~Ketamine: Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter."
256378|NCT01371110|O2|Outcome|Midazolam (Randomized Wk 1, Cross Over Ketamine Wk 3)|"Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam~Midazolam: Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant."
256379|NCT01371110|O1|Outcome|Ketamine (Randomized Week 1, Cross Over Midazolam Week 3))|"Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride~Ketamine: Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter."
256380|NCT01371110|O2|Outcome|Midazolam (Randomized Wk 1, Cross Over Ketamine Wk 3)|"Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam~Midazolam: Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant."
256381|NCT01371110|O1|Outcome|Ketamine (Randomized Week 1, Cross Over Midazolam Week 3))|"Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride~Ketamine: Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter."
269082|NCT01333397|O4|Outcome|Dysport NG 75 U|
256382|NCT01371110|E2|Reported Event|Midazolam|"Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam~Midazolam: Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant."
256383|NCT01371110|E1|Reported Event|Ketamine|"Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride~Ketamine: Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter."
256384|NCT01371006|B3|Baseline|Total|Total of all reporting groups
256385|NCT01371006|B2|Baseline|Group B: 600 mg Efavirenz+240 mg Feldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day until day 18.~Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.~oral administration with water after food intake."
256386|NCT01371006|B1|Baseline|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
256387|NCT01371006|P2|Participant Flow|Group B: 600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day until day 18.~Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.~oral administration with water after food intake."
256388|NCT01371006|P1|Participant Flow|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
256389|NCT01371006|O5|Outcome|Total On-treatment|Total number of participants with drug related adverse events during treatment.
256390|NCT01371006|O4|Outcome|Faldaprevir+Midazolam+Efavirenz|During treatment with Faldaprevir, Efavirenz, and single-dose Midazolam
256391|NCT01371006|O3|Outcome|Faldaprevir+Midazolam|During treatment with Faldaprevir and single-dose Midazolam.
256392|NCT01371006|O2|Outcome|Faldaprevir|During treatment with Faldaprevir.
256393|NCT01371006|O1|Outcome|Midazolam|Treatment with single-dose Midazolam.
256394|NCT01371006|O4|Outcome|Total On-treatment|Total number of participants with drug related adverse events during treatment.
256395|NCT01371006|O3|Outcome|Efavirenz+Faldaprevir|During treatment with Faldaprevir and single-dose Efavirenz.
256396|NCT01371006|O2|Outcome|Faldaprevir|During treatment with Faldaprevir.
256397|NCT01371006|O1|Outcome|Efavirenz|Treatment with single-dose Efavirenz.
256398|NCT01371006|O2|Outcome|Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.~oral administration with water after food intake."
256399|NCT01371006|O1|Outcome|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
256400|NCT01371006|O1|Outcome|Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.~oral administration with water after food intake."
256401|NCT01371006|O1|Outcome|Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.~oral administration with water after food intake."
256402|NCT01371006|O1|Outcome|Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.~oral administration with water after food intake."
256403|NCT01371006|O1|Outcome|Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day until day 18.~Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.~oral administration with water after food intake."
256404|NCT01371006|O1|Outcome|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
256405|NCT01371006|O1|Outcome|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
256406|NCT01371006|O1|Outcome|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
256407|NCT01371006|O1|Outcome|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
256408|NCT01371006|O1|Outcome|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
256409|NCT01371006|O2|Outcome|7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz|single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
256410|NCT01371006|O1|Outcome|7.5 mg Midazolam+240 mg Faldaprevir|single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
261077|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
256411|NCT01371006|O2|Outcome|7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz|single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
256412|NCT01371006|O1|Outcome|7.5 mg Midazolam+240 mg Faldaprevir|single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
256413|NCT01371006|O2|Outcome|7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz|single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
256414|NCT01371006|O1|Outcome|7.5 mg Midazolam+240 mg Faldaprevir|single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
256415|NCT01371006|O2|Outcome|50 mg Efavirenz+240 mg Faldaprevir|single oral administration of 50 mg Efavirenz dosed with Faldaprevir at steady state (Day 14)
256416|NCT01371006|O1|Outcome|50 mg Efavirenz|single oral administration of 50 mg Efavirenz dosed alone (Day 1)
256417|NCT01371006|O2|Outcome|50 mg Efavirenz+240 mg Faldaprevir|single oral administration of 50 mg Efavirenz dosed with Faldaprevir at steady state (Day 14)
256418|NCT01371006|O1|Outcome|50 mg Efavirenz|single oral administration of 50 mg Efavirenz dosed alone (Day 1)
256419|NCT01371006|E7|Reported Event|Group B: Faldaprevir+Midazolam+Efavirenz|During treatment with Faldaprevir, Efavirenz, and single-dose Midazolam in Group B.
256420|NCT01371006|E6|Reported Event|Group B: Faldaprevir+Midazolam|During treatment with Faldaprevir and single-dose Midazolam in Group B.
256421|NCT01371006|E5|Reported Event|Group B: Faldaprevir|During treatment with Faldaprevir in Group B.
256422|NCT01371006|E4|Reported Event|Group B: Midazolam|Treatment with single-dose Midazolam in Group B.
256423|NCT01371006|E3|Reported Event|Group A: Faldaprevir+Efavirenz|During treatment with Faldaprevir and single-dose Efavirenz in Group A.
256424|NCT01371006|E2|Reported Event|Group A: Faldaprevir|During treatment with Faldaprevir in Group A.
256425|NCT01371006|E1|Reported Event|Group A: Efavirenz|Treatment with single-dose Efavirenz in Group A.
256426|NCT01370863|B3|Baseline|Total|Total of all reporting groups
256427|NCT01370863|B2|Baseline|Placebo|Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment
256428|NCT01370863|B1|Baseline|SPD557|0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
256429|NCT01370863|P2|Participant Flow|Placebo|Matching placebo tablet administered three times daily (t.i.d.) for 4 weeks in addition to stable PPI treatment
256430|NCT01370863|P1|Participant Flow|SPD557|0.5 mg tablet administered 3 times daily (t.i.d.) for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
256431|NCT01370863|O2|Outcome|Placebo|Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment
256432|NCT01370863|O1|Outcome|SPD557|0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
256433|NCT01370863|O2|Outcome|Placebo|Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment
256434|NCT01370863|O1|Outcome|SPD557|0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
256435|NCT01370863|O2|Outcome|Placebo|Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment
256436|NCT01370863|O1|Outcome|SPD557|0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
256437|NCT01370863|E2|Reported Event|Placebo|Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment
256438|NCT01370863|E1|Reported Event|SPD557|0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
256439|NCT01370837|B4|Baseline|Total|Total of all reporting groups
256440|NCT01370837|B3|Baseline|Polyneuropathy|"Patients with diabetes and polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
256441|NCT01370837|B2|Baseline|Diabetes|"Patients with diabetes mellitus without polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
256442|NCT01370837|B1|Baseline|Healthy Controls|"Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
256443|NCT01370837|P3|Participant Flow|Polyneuropathy|"Patients with diabetes and polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
256444|NCT01370837|P2|Participant Flow|Diabetes|"Patients with diabetes mellitus without polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
256445|NCT01370837|P1|Participant Flow|Healthy Controls|"Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
256488|NCT01370655|B12|Baseline|Treatment D → Treament B|Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
256446|NCT01370837|O3|Outcome|Polyneuropathy|"Patients with diabetes and polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
256447|NCT01370837|O2|Outcome|Diabetes|"Patients with diabetes mellitus without polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
256448|NCT01370837|O1|Outcome|Healthy Controls|"Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
256449|NCT01370837|E3|Reported Event|Polyneuropathy|"Patients with diabetes and polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
256450|NCT01370837|E2|Reported Event|Diabetes|"Patients with diabetes mellitus without polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
256451|NCT01370837|E1|Reported Event|Healthy Controls|"Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
256452|NCT01370733|B3|Baseline|Total|Total of all reporting groups
256453|NCT01370733|B2|Baseline|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
256454|NCT01370733|B1|Baseline|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
256455|NCT01370733|P2|Participant Flow|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
256456|NCT01370733|P1|Participant Flow|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
256457|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
256458|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
256459|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
256460|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
256461|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
256462|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
256463|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
256464|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
256465|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
256466|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
256467|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
256489|NCT01370655|B11|Baseline|Treatment B → Treatment D|Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received Placebo MK-715 daily for 4 weeks.
256468|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
256469|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
256470|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
256471|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
256472|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
256473|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
256474|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
256475|NCT01370733|E2|Reported Event|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
256476|NCT01370733|E1|Reported Event|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
256477|NCT01370694|B1|Baseline|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
256478|NCT01370694|P1|Participant Flow|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
256479|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
256480|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
256481|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
256482|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
256483|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
256484|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
256485|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
256486|NCT01370694|E1|Reported Event|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
256487|NCT01370655|B13|Baseline|Total|Total of all reporting groups
256490|NCT01370655|B10|Baseline|Treatment C → Treatment B|Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
256491|NCT01370655|B9|Baseline|Treatment B → Treatment C|Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received HCTZ 25 mg daily for 4 weeks.
256492|NCT01370655|B8|Baseline|Treatment B → Treatment A|Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
256493|NCT01370655|B7|Baseline|Treatment A → Treatment B|Participants received 6 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
256494|NCT01370655|B6|Baseline|Treatment C → Treatment D|Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received Placebo MK-7145 daily for 4 weeks.
256495|NCT01370655|B5|Baseline|Treament D → Treatment C|Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received HCTZ 25 mg placebo daily for 4 weeks.
256496|NCT01370655|B4|Baseline|Treatment D → Treatment A|Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
256497|NCT01370655|B3|Baseline|Treatment A → Treatment D|Participants received 6 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received Placebo MK-7145 daily for 4 weeks.
256498|NCT01370655|B2|Baseline|Treatment C → Treatment A|Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
256499|NCT01370655|B1|Baseline|Treatment A → Treatment C|Participants received 6 mg MK-7145 for 4 weeks and then after a 4 week washout, received HCTZ 25 mg, daily, for 4 weeks
256500|NCT01370655|P12|Participant Flow|Treatment D → Treament B|Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
256501|NCT01370655|P11|Participant Flow|Treatment B → Treatment D|Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received Placebo MK-715 daily for 4 weeks.
256502|NCT01370655|P10|Participant Flow|Treatment C → Treatment B|Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
256503|NCT01370655|P9|Participant Flow|Treatment B → Treatment C|Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received HCTZ 25 mg daily for 4 weeks.
256504|NCT01370655|P8|Participant Flow|Treatment B → Treatment A|Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
256505|NCT01370655|P7|Participant Flow|Treatment A → Treatment B|Participants received 6 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
256506|NCT01370655|P6|Participant Flow|Treatment C → Treatment D|Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received Placebo MK-7145 daily for 4 weeks.
256507|NCT01370655|P5|Participant Flow|Treament D → Treatment C|Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received HCTZ 25 mg placebo daily for 4 weeks.
256508|NCT01370655|P4|Participant Flow|Treatment D → Treatment A|Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
256509|NCT01370655|P3|Participant Flow|Treatment A → Treatment D|Participants received 6 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received Placebo MK-7145 daily for 4 weeks.
256510|NCT01370655|P2|Participant Flow|Treatment C → Treatment A|Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
256511|NCT01370655|P1|Participant Flow|Treatment A → Treatment C|Participants received 6 mg MK-7145 for 4 weeks and then after a 4 week washout, received HCTZ 25 mg, daily, for 4 weeks
256512|NCT01370655|O4|Outcome|Placebo|Participants received Placebo MK-7145 daily for 4 weeks
256513|NCT01370655|O3|Outcome|HCTZ 25 mg|Participants received HCTZ 25 mg daily for 4 weeks
256514|NCT01370655|O2|Outcome|MK-7145 6 mg|Participants received 6 mg MK-7145 for 4 weeks
256515|NCT01370655|O1|Outcome|MK-7145 3 mg|Participants received 3 mg MK-7145 daily for 4 weeks
256516|NCT01370655|O4|Outcome|Placebo|Participants received Placebo MK-7145 daily for 4 weeks
256517|NCT01370655|O3|Outcome|HCTZ 25 mg|Participants received HCTZ 25 mg daily for 4 weeks
256518|NCT01370655|O2|Outcome|MK-7145 6 mg|Participants received 6 mg MK-7145 for 4 weeks
256519|NCT01370655|O1|Outcome|MK-7145 3 mg|Participants received 3 mg MK-7145 daily for 4 weeks
256520|NCT01370655|O4|Outcome|Placebo|Participants received Placebo MK-7145 daily for 4 weeks
256521|NCT01370655|O3|Outcome|HCTZ 25 mg|Participants received HCTZ 25 mg daily for 4 weeks
256522|NCT01370655|O2|Outcome|MK-7145 6 mg|Participants received 6 mg MK-7145 for 4 weeks
256523|NCT01370655|O1|Outcome|MK-7145 3 mg|Participants received 3 mg MK-7145 daily for 4 weeks
256524|NCT01370655|O4|Outcome|Placebo|Participants received Placebo MK-7145 daily for 4 weeks
256525|NCT01370655|O3|Outcome|HCTZ 25 mg|Participants received HCTZ 25 mg daily for 4 weeks
256526|NCT01370655|O2|Outcome|MK-7145 6 mg|Participants received 6 mg MK-7145 for 4 weeks
256527|NCT01370655|O1|Outcome|MK-7145 3 mg|Participants received 3 mg MK-7145 daily for 4 weeks
256528|NCT01370655|O4|Outcome|Placebo|Participants received Placebo MK-7145 daily for 4 weeks
256529|NCT01370655|O3|Outcome|HCTZ 25 mg|Participants received HCTZ 25 mg daily for 4 weeks
256530|NCT01370655|O2|Outcome|MK-7145 6 mg|Participants received 6 mg MK-7145 for 4 weeks
256531|NCT01370655|O1|Outcome|MK-7145 3 mg|Participants received 3 mg MK-7145 daily for 4 weeks
256532|NCT01370655|O4|Outcome|Placebo|Participants received Placebo MK-7145 daily for 4 weeks
256533|NCT01370655|O3|Outcome|HCTZ 25 mg|Participants received HCTZ 25 mg daily for 4 weeks
256534|NCT01370655|O2|Outcome|MK-7145 6 mg|Participants received 6 mg MK-7145 for 4 weeks
256535|NCT01370655|O1|Outcome|MK-7145 3 mg|Participants received 3 mg MK-7145 daily for 4 weeks
256536|NCT01370655|O4|Outcome|Placebo|Participants received Placebo MK-7145 daily for 4 weeks
256537|NCT01370655|O3|Outcome|HCTZ 25 mg|Participants received HCTZ 25 mg daily for 4 weeks
256538|NCT01370655|O2|Outcome|MK-7145 6 mg|Participants received 6 mg MK-7145 for 4 weeks
256545|NCT01370642|B3|Baseline|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
256546|NCT01370642|B2|Baseline|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
256547|NCT01370642|B1|Baseline|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
256548|NCT01370642|P3|Participant Flow|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
256549|NCT01370642|P2|Participant Flow|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
256550|NCT01370642|P1|Participant Flow|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
256551|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
256552|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
256553|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
256554|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
256555|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
256556|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
256557|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
256558|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
256559|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
256560|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
256561|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
256562|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
256563|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
256564|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
256565|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
256566|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
256567|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
256568|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
256569|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
256570|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
256571|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
256572|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
256573|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
256574|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
256575|NCT01370642|E3|Reported Event|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
256576|NCT01370642|E2|Reported Event|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
256577|NCT01370642|E1|Reported Event|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
256578|NCT01370616|B3|Baseline|Total|Total of all reporting groups
256579|NCT01370616|B2|Baseline|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
256580|NCT01370616|B1|Baseline|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
256581|NCT01370616|P2|Participant Flow|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
256582|NCT01370616|P1|Participant Flow|Ertapenem Sodium|Participants received 1.0 g intravenous (IV) ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
256583|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
256584|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
256585|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
256586|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
256587|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
256588|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
256589|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
256590|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
256591|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
256592|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
256593|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
256594|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
256595|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
256596|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
256597|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
256598|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
256599|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
261078|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
256600|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
256601|NCT01370616|E2|Reported Event|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
256602|NCT01370616|E1|Reported Event|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
256603|NCT01370603|B3|Baseline|Total|Total of all reporting groups
256604|NCT01370603|B2|Baseline|Combination/Co-administration Sequence|Ezetimibe/Atorvastatin 10 mg/40 mg fixed-dose combination then Co-administration Ezetimibe 10 mg and Atorvastatin 40 mg
256605|NCT01370603|B1|Baseline|Co-administration/Combination Sequence|Co-administration Ezetimibe 10 mg and Atorvastatin 40 mg then Ezetimibe/Atorvastatin 10 mg/40 mg fixed-dose combination
256606|NCT01370603|P2|Participant Flow|Combination/Co-administration Sequence|Ezetimibe/Atorvastatin 10 mg/40 mg fixed-dose combination then Co-administration Ezetimibe 10 mg and Atorvastatin 40 mg
256607|NCT01370603|P1|Participant Flow|Co-administration/Combination Sequence|Co-administration Ezetimibe 10 mg and Atorvastatin 40 mg then Ezetimibe/Atorvastatin 10 mg/40 mg fixed-dose combination
256608|NCT01370603|O2|Outcome|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks
256609|NCT01370603|O1|Outcome|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
256610|NCT01370603|O2|Outcome|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks
256611|NCT01370603|O1|Outcome|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
256612|NCT01370603|O2|Outcome|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks
256613|NCT01370603|O1|Outcome|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
256614|NCT01370603|O2|Outcome|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks
256615|NCT01370603|O1|Outcome|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
256616|NCT01370603|O2|Outcome|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks
256617|NCT01370603|O1|Outcome|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
256618|NCT01370603|O2|Outcome|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks
256619|NCT01370603|O1|Outcome|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
256620|NCT01370603|E2|Reported Event|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 20 mg once daily for 6 weeks
256621|NCT01370603|E1|Reported Event|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
256622|NCT01370590|B3|Baseline|Total|Total of all reporting groups
256623|NCT01370590|B2|Baseline|Combination/Coadministered Sequence|Ezetimibe/Atorvastatin 10 mg/20 mg fixed-dose combination then Co-administration Ezetimibe 10 mg and Atorvastatin 20 mg
256624|NCT01370590|B1|Baseline|Coadministered/Combination Sequence|Co-administration Ezetimibe 10 mg and Atorvastatin 20 mg then Ezetimibe/Atorvastatin 10 mg/20 mg fixed-dose combination
256625|NCT01370590|P2|Participant Flow|Combination/Coadministered Sequence|Ezetimibe/Atorvastatin 10 mg/20 mg fixed-dose combination then Co-administration Ezetimibe 10 mg and Atorvastatin 20 mg
256626|NCT01370590|P1|Participant Flow|Coadministered/Combination Sequence|Co-administration Ezetimibe 10 mg and Atorvastatin 20 mg then Ezetimibe/Atorvastatin 10 mg/20 mg fixed-dose combination
256627|NCT01370590|O2|Outcome|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with~atorvastatin 20 mg once daily for 6 weeks"
256628|NCT01370590|O1|Outcome|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
256629|NCT01370590|O2|Outcome|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with~atorvastatin 20 mg once daily for 6 weeks"
256630|NCT01370590|O1|Outcome|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
256631|NCT01370590|O2|Outcome|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with~atorvastatin 20 mg once daily for 6 weeks"
256632|NCT01370590|O1|Outcome|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
256633|NCT01370590|O2|Outcome|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with~atorvastatin 20 mg once daily for 6 weeks"
256634|NCT01370590|O1|Outcome|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
256635|NCT01370590|O2|Outcome|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with~atorvastatin 20 mg once daily for 6 weeks"
256636|NCT01370590|O1|Outcome|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
256637|NCT01370590|O2|Outcome|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with~atorvastatin 20 mg once daily for 6 weeks"
256638|NCT01370590|O1|Outcome|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
256639|NCT01370590|E2|Reported Event|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with~atorvastatin 20 mg once daily for 6 weeks"
269083|NCT01333397|O3|Outcome|Dysport NG 50 U|
256640|NCT01370590|E1|Reported Event|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
256641|NCT01370538|B3|Baseline|Total|Total of all reporting groups
256642|NCT01370538|B2|Baseline|Placebo|Placebo for Esomeprazole
256643|NCT01370538|B1|Baseline|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
256644|NCT01370538|P2|Participant Flow|Placebo|Placebo for Esomeprazole
256645|NCT01370538|P1|Participant Flow|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
256646|NCT01370538|O2|Outcome|Placebo|Placebo for Esomeprazole
256647|NCT01370538|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
256648|NCT01370538|O2|Outcome|Placebo|Placebo for Esomeprazole
256649|NCT01370538|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
256650|NCT01370538|O2|Outcome|Placebo|Placebo for Esomeprazole
256651|NCT01370538|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
256652|NCT01370538|O2|Outcome|Placebo|Placebo for Esomeprazole
256653|NCT01370538|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
256654|NCT01370538|O2|Outcome|Placebo|Placebo for Esomeprazole
256655|NCT01370538|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
256656|NCT01370538|E2|Reported Event|Placebo|Placebo for Esomeprazole
256657|NCT01370538|E1|Reported Event|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
256658|NCT01370525|B3|Baseline|Total|Total of all reporting groups
256659|NCT01370525|B2|Baseline|Placebo|Placebo for Esomeprazole
256660|NCT01370525|B1|Baseline|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
256661|NCT01370525|P2|Participant Flow|Placebo|Placebo for Esomeprazole
256662|NCT01370525|P1|Participant Flow|Esomeprazole|Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate
256663|NCT01370525|O2|Outcome|Placebo|Placebo for Esomeprazole
256664|NCT01370525|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
256665|NCT01370525|O2|Outcome|Placebo|Placebo for Esomeprazole
256666|NCT01370525|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
256667|NCT01370525|O2|Outcome|Placebo|Placebo for Esomeprazole
256668|NCT01370525|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
256669|NCT01370525|O2|Outcome|Placebo|Placebo for Esomeprazole
256670|NCT01370525|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
256671|NCT01370525|O2|Outcome|Placebo|Placebo for Esomeprazole
256672|NCT01370525|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
256673|NCT01370525|E2|Reported Event|Placebo|Placebo for Esomeprazole
256674|NCT01370525|E1|Reported Event|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
256675|NCT01370460|B3|Baseline|Total|Total of all reporting groups
256676|NCT01370460|B2|Baseline|Placebo|100mL 0.9% NS, applied topically
256677|NCT01370460|B1|Baseline|Tranexamic Acid|Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
256678|NCT01370460|P2|Participant Flow|Placebo|100mL 0.9% NS, applied topically
256679|NCT01370460|P1|Participant Flow|Tranexamic Acid|Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
256680|NCT01370460|O2|Outcome|Placebo|100mL 0.9% NS, applied topically
256681|NCT01370460|O1|Outcome|Tranexamic Acid|Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
256682|NCT01370460|O2|Outcome|Tranexamic Acid|Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
256683|NCT01370460|O1|Outcome|Placebo|100mL 0.9% NS, applied topically
256684|NCT01370460|E1|Reported Event|Adverse Events Not Collected|Adverse Events Not Collected
256685|NCT01370408|B1|Baseline|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
256686|NCT01370408|P1|Participant Flow|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
256687|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
256688|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
256703|NCT01370369|O1|Outcome|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
269084|NCT01333397|O2|Outcome|Dysport NG 20 U|
256689|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
256690|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
256691|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
256692|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
256693|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
256694|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
256695|NCT01370408|E1|Reported Event|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
256696|NCT01370369|B1|Baseline|Testosterone Topical|"For single dose PKs, a single application of 2.50 mL (two strokes) of the testosterone gel 2% was applied to the inner thigh followed by a 7-day washout period. After this washout period, the second single application of 2.50 mL (two strokes) of the testosterone gel 2% was applied to the abdomen followed by another 7-day washout period. After this washout period, the third single application of 2.50 mL (2 strokes) of the testosterone gel 2% was applied to the shoulder/upper arm.~After the last 24 hour PK sampling from the shoulder/upper arm, 3 ascending doses of testosterone gel 2%, 1.25, 2.50 and 3.75 mL (1 stroke, 2 strokes and 3 strokes, respectively), were sequentially applied once daily for 10 consecutive days to the shoulder/upper arm. Steady-state PK evaluations were performed starting on the morning of the last administered dose. There was no washout between each of the 10-day treatments."
256697|NCT01370369|P1|Participant Flow|Testosterone Topical|"For single dose pharmacokinetics (PKs), a single application of 2.50 mL (two strokes) of the testosterone gel 2% was applied to the inner thigh followed by a 7-day washout period. After this washout period, the second single application of 2.50 mL (two strokes) of the testosterone gel 2% was applied to the abdomen followed by another 7-day washout period. After this washout period, the third single application of 2.50 mL (two strokes) of the testosterone gel 2% was applied to the shoulder/upper arm.~After the last 24 hour PK sampling from the shoulder/upper arm, three ascending doses of testosterone gel 2%, 1.25, 2.50 and 3.75 mL (one stroke, two strokes and three strokes, respectively), were sequentially applied once daily for 10 consecutive days to the shoulder/upper arm. Steady-state PK evaluations were performed starting on the morning of the last administered dose. There was no washout between each of the 10-day treatments."
256698|NCT01370369|O3|Outcome|Testosterone 3.75|Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256699|NCT01370369|O2|Outcome|Testosterone 2.50|Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256700|NCT01370369|O1|Outcome|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256701|NCT01370369|O3|Outcome|Testosterone 3.75|Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256702|NCT01370369|O2|Outcome|Testosterone 2.50|Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
269085|NCT01333397|O1|Outcome|Placebo|
256704|NCT01370369|O3|Outcome|Testosterone 3.75|Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256705|NCT01370369|O2|Outcome|Testosterone 2.50|Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256706|NCT01370369|O1|Outcome|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256707|NCT01370369|O3|Outcome|Testosterone 3.75|Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256708|NCT01370369|O2|Outcome|Testosterone 2.50|Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256709|NCT01370369|O1|Outcome|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256710|NCT01370369|O3|Outcome|Testosterone 3.75|Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256711|NCT01370369|O2|Outcome|Testosterone 2.50|Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256712|NCT01370369|O1|Outcome|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256713|NCT01370369|O3|Outcome|Testosterone 3.75|Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256714|NCT01370369|O2|Outcome|Testosterone 2.50|Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256715|NCT01370369|O1|Outcome|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256716|NCT01370369|O3|Outcome|Testosterone 3.75|Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256717|NCT01370369|O2|Outcome|Testosterone 2.50|Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256718|NCT01370369|O1|Outcome|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256719|NCT01370369|O3|Outcome|Testosterone 3.75|Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256720|NCT01370369|O2|Outcome|Testosterone 2.50|Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256721|NCT01370369|O1|Outcome|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256722|NCT01370369|O3|Outcome|Testosterone 3.75|Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256723|NCT01370369|O2|Outcome|Testosterone 2.50|Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256724|NCT01370369|O1|Outcome|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (One stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256725|NCT01370369|O3|Outcome|Testosterone 3.75|Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256726|NCT01370369|O2|Outcome|Testosterone 2.50|Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256727|NCT01370369|O1|Outcome|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256728|NCT01370369|O3|Outcome|Single Testosterone Dose (Shoulder/Upper Arm)|Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the shoulder/upper arm.
256729|NCT01370369|O2|Outcome|Single Testosterone Dose (Abdomen)|Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the abdomen followed by a 7-day washout period.
256730|NCT01370369|O1|Outcome|Single Testosterone Dose (Inner Thigh)|Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the inner thigh followed by a 7-day washout period.
256731|NCT01370369|O3|Outcome|Single Testosterone Dose (Shoulder/Upper Arm)|Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the shoulder/upper arm.
256732|NCT01370369|O2|Outcome|Single Testosterone Dose (Abdomen)|Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the abdomen thigh followed by a seven day washout period.
256733|NCT01370369|O1|Outcome|Single Testosterone Dose (Inner Thigh)|Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the inner thigh followed by a 7-day washout period.
256734|NCT01370369|O3|Outcome|Single Testosterone Dose (Shoulder/Upper Arm)|Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the shoulder/upper arm.
256815|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
256735|NCT01370369|O2|Outcome|Single Testosterone Dose (Abdomen)|Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the abdomen followed by a 7-day washout period.
256736|NCT01370369|O1|Outcome|Single Testosterone Dose (Inner Thigh)|Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the inner thigh followed by a 7-day washout period.
256737|NCT01370369|O3|Outcome|Testosterone 3.75|Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256738|NCT01370369|O2|Outcome|Testosterone 2.50|Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256739|NCT01370369|O1|Outcome|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256740|NCT01370369|E3|Reported Event|Testosterone 3.75|Subjects received testosterone gel 2% at dose of 3.75 mL (3 strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256741|NCT01370369|E2|Reported Event|Testosterone 2.50|Subjects received testosterone gel 2% at dose of 2.50 mL (2 strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256742|NCT01370369|E1|Reported Event|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (1 stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
256743|NCT01370356|B3|Baseline|Total|Total of all reporting groups
256744|NCT01370356|B2|Baseline|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed. Data below are presented for the treated population.
256745|NCT01370356|B1|Baseline|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID. One participant was assigned to varenicline as a male but is in fact female. Data below are presented for the treated population.
256746|NCT01370356|P2|Participant Flow|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed. Data below are presented for the treated population.
256747|NCT01370356|P1|Participant Flow|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg twice daily [BID]). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID. Data below are presented for the treated population.
256748|NCT01370356|O2|Outcome|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
256749|NCT01370356|O1|Outcome|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
256750|NCT01370356|O2|Outcome|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
256751|NCT01370356|O1|Outcome|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
256752|NCT01370356|O2|Outcome|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
256753|NCT01370356|O1|Outcome|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
256754|NCT01370356|O2|Outcome|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
256755|NCT01370356|O1|Outcome|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
256756|NCT01370356|O2|Outcome|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
256757|NCT01370356|O1|Outcome|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
256758|NCT01370356|E2|Reported Event|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
256759|NCT01370356|E1|Reported Event|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
256760|NCT01370265|B1|Baseline|Entire Study Population|Includes groups randomized to receive Regadenoson first and Adenosine first.
256761|NCT01370265|P2|Participant Flow|Adenosine, Then Regadenoson|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes in the first intervention period. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered. After a washout period, Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush in the second intervention period.
256816|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
269086|NCT01333397|O5|Outcome|Dysport 50 U|
256762|NCT01370265|P1|Participant Flow|Regadenoson, Then Adenosine|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush in the first intervention period. Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes in the second intervention period (after washout period). Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
256763|NCT01370265|O2|Outcome|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
256764|NCT01370265|O1|Outcome|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
256765|NCT01370265|O2|Outcome|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
256766|NCT01370265|O1|Outcome|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
256767|NCT01370265|O2|Outcome|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
256768|NCT01370265|O1|Outcome|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
256769|NCT01370265|O2|Outcome|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
256770|NCT01370265|O1|Outcome|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
256771|NCT01370265|O2|Outcome|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
256772|NCT01370265|O1|Outcome|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
256773|NCT01370265|O1|Outcome|Entire Study Population|Includes groups randomized to receive Regadenoson first and Adenosine first.
256774|NCT01370265|O2|Outcome|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
256775|NCT01370265|O1|Outcome|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
256776|NCT01370265|E2|Reported Event|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
256777|NCT01370265|E1|Reported Event|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
256778|NCT01370083|B3|Baseline|Total|Total of all reporting groups
256779|NCT01370083|B2|Baseline|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.~Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
256780|NCT01370083|B1|Baseline|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.~Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
256781|NCT01370083|P2|Participant Flow|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.~Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
256782|NCT01370083|P1|Participant Flow|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.~Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
256783|NCT01370083|O2|Outcome|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.~Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
256817|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
256818|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
256819|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
256784|NCT01370083|O1|Outcome|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.~Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
256785|NCT01370083|O2|Outcome|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.~Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
256786|NCT01370083|O1|Outcome|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.~Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
256787|NCT01370083|O2|Outcome|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.~Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
256788|NCT01370083|O1|Outcome|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.~Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
256789|NCT01370083|E2|Reported Event|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.~Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
256790|NCT01370083|E1|Reported Event|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.~Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
256791|NCT01370005|B4|Baseline|Total|Total of all reporting groups
256792|NCT01370005|B3|Baseline|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
256793|NCT01370005|B2|Baseline|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
256794|NCT01370005|B1|Baseline|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
256795|NCT01370005|P3|Participant Flow|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
256796|NCT01370005|P2|Participant Flow|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
256797|NCT01370005|P1|Participant Flow|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
256798|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
256799|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
256800|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
256801|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
256802|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
256803|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
256804|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
256805|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
256806|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
256807|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
256808|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
256809|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
256810|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
256811|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
256812|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
256813|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
256814|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
256820|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
256821|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
256822|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
256823|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
256824|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
256825|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
256826|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
256827|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
256828|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
256829|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
256830|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
256831|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
256832|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
256833|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
256834|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
256835|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
256836|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
256837|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
256838|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
256839|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
256840|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
256841|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
256842|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
256843|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
256844|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
256845|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
256846|NCT01370005|E3|Reported Event|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
256847|NCT01370005|E2|Reported Event|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
256848|NCT01370005|E1|Reported Event|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
256849|NCT01369888|B5|Baseline|Total|Total of all reporting groups
256850|NCT01369888|B4|Baseline|IL-15 Following Young TIL (2 mcg)|"2 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
256851|NCT01369888|B3|Baseline|IL-15 Following Young TIL (10.50 mcg)|"1 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
256852|NCT01369888|B2|Baseline|IL-15 Following Young TIL (0.50 mcg)|"0.50 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
256853|NCT01369888|B1|Baseline|IL-15 Following Young TIL (0.25 mcg)|"0.25 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
256854|NCT01369888|P4|Participant Flow|IL-15 Following Young TIL (2 mcg)|"2 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
256855|NCT01369888|P3|Participant Flow|IL-15 Following Young TIL (1 mcg)|"1 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
256856|NCT01369888|P2|Participant Flow|IL-15 Following Young TIL (0.50 mcg)|"0.50 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
256857|NCT01369888|P1|Participant Flow|IL-15 Following Young TIL (0.25 mcg)|"0.25 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
256858|NCT01369888|O2|Outcome|IL-15 Following Young TIL (0.50 mcg)|"0.50 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
256859|NCT01369888|O1|Outcome|IL-15 Following Young TIL (0.25 mcg)|"0.25 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
256860|NCT01369888|O2|Outcome|IL-15 Following Young TIL (0.50 mcg)|"0.50 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
256861|NCT01369888|O1|Outcome|IL-15 Following Young TIL (0.25 mcg)|"0.25 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
256862|NCT01369888|E2|Reported Event|IL-15 Following Young TIL (0.50 mcg)|"0.50 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
256863|NCT01369888|E1|Reported Event|IL-15 Following Young TIL (0.25 mcg)|"0.25 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
256864|NCT01369875|B3|Baseline|Total|Total of all reporting groups
256865|NCT01369875|B2|Baseline|ECCE Young TIL|"Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
256866|NCT01369875|B1|Baseline|Standard Young TIL|"Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
256867|NCT01369875|P2|Participant Flow|ECCE Young TIL|"Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
256868|NCT01369875|P1|Participant Flow|Standard Young TIL|"Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
256869|NCT01369875|O2|Outcome|ECCE Young TIL|"Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
256870|NCT01369875|O1|Outcome|Standard Young TIL|"Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
256871|NCT01369875|O2|Outcome|ECCE Young TIL|"Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
256872|NCT01369875|O1|Outcome|Standard Young TIL|"Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
256873|NCT01369875|E2|Reported Event|ECCE Young TIL|"Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
256960|NCT01369745|O3|Outcome|Prednisone|Prednisone 5 mg once daily
256961|NCT01369745|O2|Outcome|Dipyridamole|dipyridamole 360 mg once daily
256874|NCT01369875|E1|Reported Event|Standard Young TIL|"Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
256875|NCT01369849|B4|Baseline|Total|Total of all reporting groups
256876|NCT01369849|B3|Baseline|Phase II|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
256877|NCT01369849|B2|Baseline|Phase I: Dose Level 2|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 135 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
256878|NCT01369849|B1|Baseline|Phase I: Dose Level 1|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
256879|NCT01369849|P3|Participant Flow|Phase II|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
256880|NCT01369849|P2|Participant Flow|Phase I: Dose Level 2|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 135 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
256881|NCT01369849|P1|Participant Flow|Phase I: Dose Level 1|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
256882|NCT01369849|O1|Outcome|All Patients|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO (90 or 135 mg) on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
256883|NCT01369849|O1|Outcome|All Patients|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO (90 or 135 mg) on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
256884|NCT01369849|O1|Outcome|All Patients|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO (90 or 135 mg) on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
256885|NCT01369849|O1|Outcome|All Patients|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO (90 or 135 mg) on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
256886|NCT01369849|O3|Outcome|Phase II|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
256887|NCT01369849|O2|Outcome|Phase I: Dose Level 2|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 135 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
256888|NCT01369849|O1|Outcome|Phase I: Dose Level 1|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
256889|NCT01369849|O3|Outcome|Phase II|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
256890|NCT01369849|O2|Outcome|Phase I: Dose Level 2|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 135 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
256891|NCT01369849|O1|Outcome|Phase I: Dose Level 1|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
256892|NCT01369849|O3|Outcome|Phase II|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
256962|NCT01369745|O1|Outcome|Prednisolone|Prednisolone 2.7 mg once daily
256963|NCT01369745|O5|Outcome|Placebo|placebo once daily
256964|NCT01369745|O4|Outcome|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily
256893|NCT01369849|O2|Outcome|Phase I: Dose Level 2|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 135 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
256894|NCT01369849|O1|Outcome|Phase I: Dose Level 1|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
256895|NCT01369849|O1|Outcome|Dose Level 1|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
256896|NCT01369849|O3|Outcome|Phase II|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
256897|NCT01369849|O2|Outcome|Phase I: Dose Level 2|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 135 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
256898|NCT01369849|O1|Outcome|Phase I: Dose Level 1|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
256899|NCT01369849|E3|Reported Event|Phase II|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
256900|NCT01369849|E2|Reported Event|Phase I: Dose Level 2|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 135 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
256901|NCT01369849|E1|Reported Event|Phase I: Dose Level 1|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
256902|NCT01369784|B1|Baseline|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
256903|NCT01369784|P1|Participant Flow|Refractory/Relapsed LDCBG (Diffuse Large-B-cell Lymphoma)|patients with refractory/relapsed diffuse large B-cell lymphoma
256904|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
256905|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
256906|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
256907|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
256908|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
256909|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
256910|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
256911|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
256912|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
256913|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
256914|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
256915|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
256916|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
256917|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
256918|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
256919|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
256920|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
256921|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
256922|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
256923|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
256924|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
256925|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
256926|NCT01369784|E1|Reported Event|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
256965|NCT01369745|O3|Outcome|Prednisone|Prednisone 5 mg once daily
256966|NCT01369745|O2|Outcome|Dipyridamole|dipyridamole 360 mg once daily
256967|NCT01369745|O1|Outcome|Prednisolone|Prednisolone 2.7 mg once daily
256968|NCT01369745|E5|Reported Event|Placebo|placebo once daily
256969|NCT01369745|E4|Reported Event|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily
256927|NCT01369758|B1|Baseline|Intrauterine Pathology, Myomectomy|"Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure.~MyoSure Tissue Removal System: The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade. When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle."
256928|NCT01369758|P1|Participant Flow|Intrauterine Pathology, Myomectomy|"Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure.~MyoSure Tissue Removal System: The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade. When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle."
256929|NCT01369758|O1|Outcome|Intrauterine Pathology, Myomectomy|"Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure.~MyoSure Tissue Removal System: The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade. When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle."
256930|NCT01369758|O1|Outcome|Intrauterine Pathology, Myomectomy|"Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure.~MyoSure Tissue Removal System: The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade. When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle."
256931|NCT01369758|E1|Reported Event|Intrauterine Pathology, Myomectomy|"Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure.~MyoSure Tissue Removal System: The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade. When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle."
256932|NCT01369745|B6|Baseline|Total|Total of all reporting groups
256933|NCT01369745|B5|Baseline|Placebo|placebo once daily
256934|NCT01369745|B4|Baseline|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily The trial would progress from Stage 3 to Stage 5 if the posterior probability that Z102 is superior to prednisolone 2.7 was greater than 0.975.
256935|NCT01369745|B3|Baseline|Prednisone|Prednisone 5 mg once daily The trial would progress from Stage 2 to Stage 4 if the posterior probability that Z102 is superior to prednisolone 2.7 was greater than 0.975.
256936|NCT01369745|B2|Baseline|Dipyridamole|dipyridamole 360 mg once daily The trial would progress from Stage 2 to Stage 3 if the posterior probability that Z102 is superior to dipyridamole was greater than 0.975.
256937|NCT01369745|B1|Baseline|Prednisolone|Prednisolone 2.7 mg once daily The trial would progress from Stage 1 to Stage 2 if the posterior probability that Z102 is superior to placebo was greater than 0.975.
256938|NCT01369745|P5|Participant Flow|Placebo|placebo once daily
256939|NCT01369745|P4|Participant Flow|Z102|2.7 mg prednisolone plus 360 mg dipyridamole once daily
256940|NCT01369745|P3|Participant Flow|Prednisone|Prednisone 5 mg once daily
256941|NCT01369745|P2|Participant Flow|Dipyridamole|dipyridamole 360 mg once daily
256942|NCT01369745|P1|Participant Flow|Prednisolone|Prednisolone 2.7 mg once daily
256943|NCT01369745|O5|Outcome|Placebo|placebo once daily
256944|NCT01369745|O4|Outcome|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily
256945|NCT01369745|O3|Outcome|Prednisone|Prednisone 5 mg once daily
256946|NCT01369745|O2|Outcome|Dipyridamole|dipyridamole 360 mg once daily
256947|NCT01369745|O1|Outcome|Prednisolone|Prednisolone 2.7 mg once daily
256948|NCT01369745|O5|Outcome|Placebo|placebo once daily
256949|NCT01369745|O4|Outcome|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily
256950|NCT01369745|O3|Outcome|Prednisone|Prednisone 5 mg once daily
256951|NCT01369745|O2|Outcome|Dipyridamole|dipyridamole 360 mg once daily
256952|NCT01369745|O1|Outcome|Prednisolone|Prednisolone 2.7 mg once daily
256953|NCT01369745|O5|Outcome|Placebo|placebo once daily
256954|NCT01369745|O4|Outcome|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily
256955|NCT01369745|O3|Outcome|Prednisone|Prednisone 5 mg once daily
256956|NCT01369745|O2|Outcome|Dipyridamole|dipyridamole 360 mg once daily
256957|NCT01369745|O1|Outcome|Prednisolone|Prednisolone 2.7 mg once daily
256958|NCT01369745|O5|Outcome|Placebo|placebo once daily
256959|NCT01369745|O4|Outcome|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily
256974|NCT01369732|B2|Baseline|Erythropoietin Group|We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
256975|NCT01369732|B1|Baseline|Saline Group|We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.
256976|NCT01369732|P2|Participant Flow|Erythropoietin Group|We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
256977|NCT01369732|P1|Participant Flow|Saline Group|We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.
256978|NCT01369732|O2|Outcome|Erythropoietin Group|We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
256979|NCT01369732|O1|Outcome|Saline Group|We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.
256980|NCT01369732|E2|Reported Event|Erythropoietin Group|We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
256981|NCT01369732|E1|Reported Event|Saline Group|We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.
256982|NCT01369706|B1|Baseline|Hand-held Metal Detector|"Exposure to two hand-held metal detectors~Hand-held metal detector: 2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)"
256983|NCT01369706|P1|Participant Flow|Hand-held Metal Detector|"Exposure to two hand-held metal detectors~Hand-held metal detector: 2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)"
256984|NCT01369706|O1|Outcome|Hand-held Metal Detector|"Exposure to two hand-held metal detectors~Hand-held metal detector: 2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)"
256985|NCT01369706|E1|Reported Event|Hand-held Metal Detector|"Exposure to two hand-held metal detectors~Hand-held metal detector: 2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)"
256986|NCT01369680|B5|Baseline|Total|Total of all reporting groups
256987|NCT01369680|B4|Baseline|Ketamine 1.5 mg/kg/Dose|Cohort of three participants treated at 1.5 mg/kg/dose oral ketamine.
256988|NCT01369680|B3|Baseline|Ketamine 1 mg/kg/Dose|Cohort of three participants treated at 1 mg/kg/dose oral ketamine.
256989|NCT01369680|B2|Baseline|Ketamine 0.5 mg/kg/Dose|Cohort of three participants treated at 0.5 mg/kg/dose oral ketamine.
256990|NCT01369680|B1|Baseline|Ketamine 0.25 mg/kg/Dose|Cohort of three participants treated at 0.25 mg/kg/dose oral ketamine.
256991|NCT01369680|P4|Participant Flow|Ketamine 1.5 mg/kg/Dose|Cohort of three participants treated at 1.5 mg/kg/dose oral ketamine.
256992|NCT01369680|P3|Participant Flow|Ketamine 1 mg/kg/Dose|Cohort of three participants treated at 1 mg/kg/dose oral ketamine.
256993|NCT01369680|P2|Participant Flow|Ketamine 0.5 mg/kg/Dose|Cohort of three participants treated at 0.5 mg/kg/dose oral ketamine.
256994|NCT01369680|P1|Participant Flow|Ketamine 0.25 mg/kg/Dose|Cohort of three participants treated at 0.25 mg/kg/dose oral ketamine.
256995|NCT01369680|O4|Outcome|Ketamine 1.5 mg/kg/Dose|Cohort of three subjects administered 1.5 mg/kg/dose oral ketamine.
256996|NCT01369680|O3|Outcome|Ketamine 1 mg/kg/Dose|Cohort of three subjects administered 0.25 mg/kg/dose oral ketamine.
256997|NCT01369680|O2|Outcome|Ketamine 0.5 mg/kg/Dose|Cohort of three subjects administered 0.5 mg/kg/dose oral ketamine.
256998|NCT01369680|O1|Outcome|Ketamine 0.25 mg/kg/Dose|Cohort of three subjects administered 0.25 mg/kg/dose oral ketamine.
256999|NCT01369680|O3|Outcome|Ketamine 1 mg/kg/Dose|Subjects treated at 1 mg/kg/dose consenting for separate pharmacokinetics test at week 1 of study.
257000|NCT01369680|O2|Outcome|Ketamine 0.5 mg/kg/Dose|Subjects treated at 0.5 mg/kg/dose consenting for separate pharmacokinetics test at week 1 of study.
257001|NCT01369680|O1|Outcome|Ketamine 0.25 mg/kg/Dose|Subjects treated at 0.25 mg/kg/dose consenting for separate pharmacokinetics test at week 1 of study.
257002|NCT01369680|O4|Outcome|Ketamine 1.5 mg/kg/Dose|Cohort of three subjects administered 1.5 mg/kg/dose oral ketamine. Measure was for clinically significant decline in neurocognitive scores.
257003|NCT01369680|O3|Outcome|Ketamine 1 mg/kg/Dose|Cohort of three subjects administered 1 mg/kg/dose oral ketamine. Measure was for clinically significant decline in neurocognitive scores.
257004|NCT01369680|O2|Outcome|Ketamine 0.5 mg/kg/Dose|Cohort of three subjects administered 0.5 mg/kg/dose oral ketamine. Measure was for clinically significant decline in neurocognitive scores.
257005|NCT01369680|O1|Outcome|Ketamine 0.25 mg/kg/Dose|Cohort of three subjects administered 0.25 mg/kg/dose oral ketamine. Measure was for clinically significant decline in neurocognitive scores.
257006|NCT01369680|O4|Outcome|Ketamine 1.5 mg/kg/Dose|Cohort of three subjects administered 1.5 mg/kg/dose oral ketamine
257007|NCT01369680|O3|Outcome|Ketamine 1 mg/kg/Dose|Cohort of three subjects administered 1 mg/kg/dose oral ketamine
257008|NCT01369680|O2|Outcome|Ketamine 0.5 mg/kg/Dose|Cohort of three subjects administered 0.5 mg/kg/dose oral ketamine
257009|NCT01369680|O1|Outcome|Ketamine 0.25 mg/kg/Dose|Cohort of three subjects administered 0.25 mg/kg/dose oral ketamine
257010|NCT01369680|E4|Reported Event|Ketamine 1.5 mg/kg/Dose|Cohort of three participants treated at 1.5 mg/kg/dose oral ketamine.
257011|NCT01369680|E3|Reported Event|Ketamine 1 mg/kg/Dose|Cohort of three participants treated at 1 mg/kg/dose oral ketamine.
257012|NCT01369680|E2|Reported Event|Ketamine 0.5 mg/kg/Dose|Cohort of three participants treated at 0.5 mg/kg/dose oral ketamine.
257013|NCT01369680|E1|Reported Event|Ketamine 0.25 mg/kg/Dose|Cohort of three participants treated at 0.25 mg/kg/dose oral ketamine.
257014|NCT01369641|B1|Baseline|Sodium Thiosulfate (STS) Ear & Placebo Ear|"Subjects enrolled to study will have their ears randomized for treatment with STS. The experimental ear will receive STS treatments, while the comparator ear will receive a placebo.~Insertion of Pressure Equalization (PE) Tubes: If the subject consents to participate in the study, a separate consent for insertion of pressure equalization (PE) tubes will be obtained. The PE tubes will then be inserted into the posterior inferior quadrant of the tympanic membrane in the office under topical anesthesia.~Sodium Thiosulfate (STS): Drops of STS will be added to the experimental ear only prior to initial cisplatin infusion.~Cisplatin: Cisplatin chemotherapy infusion in the dose range of 80-120mg/m2"
257015|NCT01369641|P1|Participant Flow|Sodium Thiosulfate (STS) Ear & Placebo Ear|"Subjects enrolled to study will have their ears randomized for treatment with STS. The experimental ear will receive STS treatments, while the comparator ear will receive a placebo.~Insertion of Pressure Equalization (PE) Tubes: If the subject consents to participate in the study, a separate consent for insertion of pressure equalization (PE) tubes will be obtained. The PE tubes will then be inserted into the posterior inferior quadrant of the tympanic membrane in the office under topical anesthesia.~Sodium Thiosulfate (STS): Drops of STS will be added to the experimental ear only prior to initial cisplatin infusion.~Cisplatin: Cisplatin chemotherapy infusion in the dose range of 80-120mg/m2"
257016|NCT01369641|O1|Outcome|Sodium Thiosulfate (STS) Ear & Placebo Ear|"Subjects enrolled to study will have their ears randomized for treatment with STS. The experimental ear will receive STS treatments, while the comparator ear will receive a placebo.~Insertion of Pressure Equalization (PE) Tubes: If the subject consents to participate in the study, a separate consent for insertion of pressure equalization (PE) tubes will be obtained. The PE tubes will then be inserted into the posterior inferior quadrant of the tympanic membrane in the office under topical anesthesia.~Sodium Thiosulfate (STS): Drops of STS will be added to the experimental ear only prior to initial cisplatin infusion.~Cisplatin: Cisplatin chemotherapy infusion in the dose range of 80-120mg/m2"
257017|NCT01369641|E1|Reported Event|Sodium Thiosulfate (STS) Ear & Placebo Ear|"Subjects enrolled to study will have their ears randomized for treatment with STS. The experimental ear will receive STS treatments, while the comparator ear will receive a placebo.~Insertion of Pressure Equalization (PE) Tubes: If the subject consents to participate in the study, a separate consent for insertion of pressure equalization (PE) tubes will be obtained. The PE tubes will then be inserted into the posterior inferior quadrant of the tympanic membrane in the office under topical anesthesia.~Sodium Thiosulfate (STS): Drops of STS will be added to the experimental ear only prior to initial cisplatin infusion.~Cisplatin: Cisplatin chemotherapy infusion in the dose range of 80-120mg/m2"
257018|NCT01369615|B3|Baseline|Total|Total of all reporting groups
257019|NCT01369615|B2|Baseline|≥ 12 to ≤ 16 Years|Children 12 to ≤ 16 years of age
257020|NCT01369615|B1|Baseline|6 to < 12 Years|Children 6 to < 12 years of age
257021|NCT01369615|P2|Participant Flow|≥ 12 to ≤ 16 Years|Although the protocol for study OTR3002 defined the age range as 6 to 17 years inclusive, no patients greater than 16 years of age were included in the study. Therefore the data summaries presented the upper limit of the older age group as ≤ 16 years.
257022|NCT01369615|P1|Participant Flow|6 to < 12 Years|Children 6 to < 12 years of age
257023|NCT01369615|O2|Outcome|≥ 12 to ≤ 16 Years|Test treatment: open-label oxycodone HCl CR tablets, 20 mg to 240 mg total daily
257024|NCT01369615|O1|Outcome|6 to < 12 Years|Test treatment: open-label oxycodone HCl CR tablets, 20 mg to 240 mg total daily
257025|NCT01369615|E2|Reported Event|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
257026|NCT01369615|E1|Reported Event|6 to < 12 Years|Children 6 to < 12 years of age
257027|NCT01369485|B3|Baseline|Total|Total of all reporting groups
257028|NCT01369485|B2|Baseline|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257029|NCT01369485|B1|Baseline|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257030|NCT01369485|P2|Participant Flow|Randomized Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete.~Patients completing ther randomized phase of the study were rolled over to receive active treatment with VERV™ System for up to 9 additional months."
257031|NCT01369485|P1|Participant Flow|Randomized Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete.~Patients completing ther randomized phase of the study were rolled over to receive active treatment with VERV™ System for up to 9 additional months."
257032|NCT01369485|O4|Outcome|Open Label Sham Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
257033|NCT01369485|O3|Outcome|Open Label Active Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
257034|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257035|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257036|NCT01369485|O4|Outcome|Open Label Sham Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
257037|NCT01369485|O3|Outcome|Open Label Active Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
257038|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257039|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
269087|NCT01333397|O4|Outcome|Dysport NG 75 U|
257040|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257041|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257042|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257043|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257044|NCT01369485|O4|Outcome|Open Label Sham Treatement Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
257045|NCT01369485|O3|Outcome|Open Label Active Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
257046|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257047|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257048|NCT01369485|O4|Outcome|Open Label Sham Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
257049|NCT01369485|O3|Outcome|Open Label Active Treatment Group.|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
257050|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257051|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257052|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257053|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257054|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257055|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257056|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257057|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257058|NCT01369485|O4|Outcome|Open Label Sham Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257059|NCT01369485|O3|Outcome|Open Label Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257060|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257061|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257062|NCT01369485|O4|Outcome|Open Label Sham Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
257063|NCT01369485|O3|Outcome|Open Label Active Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
257119|NCT01369342|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
257064|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257065|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257066|NCT01369485|E4|Reported Event|Open Label Sham Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for up to 9 additional months, one per week during the open label phase."
257067|NCT01369485|E3|Reported Event|Open Label Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for up to 9 additional months, one per week during the open label phase."
257068|NCT01369485|E2|Reported Event|Randomized Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257069|NCT01369485|E1|Reported Event|Randomized Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
257070|NCT01369355|B7|Baseline|Total|Total of all reporting groups
257071|NCT01369355|B6|Baseline|UST-I-nonRsp - UST-90mg Subcutaneously (SC) Q8W Maintenance|Participants (who were not in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab 90 mg SC on entry into maintenance followed by Ustekinumab 90 mg SC q8w beginning at Week 8 of maintenance (if in response).
257072|NCT01369355|B5|Baseline|PBO-I-nonRsp - UST-130mg Intravenous/90mg SC Q12W Maintenance|Participants (who were not in clinical response to placebo IV at Week 8 of an induction study) received Ustekinumab 130 mg IV on entry into maintenance followed by Ustekinumab 90 mg SC q12 weeks beginning at Week 8 of maintenance (if in response).
257073|NCT01369355|B4|Baseline|Placebo (PBO)-I-Rsp - PBO Maintenance|Participants (who were in clinical response to placebo IV at Week 8 of an induction study) received placebo SC q4w in the maintenance study.
257074|NCT01369355|B3|Baseline|UST-I-Rsp-UST-90 mg Q8W Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study.
257075|NCT01369355|B2|Baseline|UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 milligrams (mg) q12w in the maintenance study.
257076|NCT01369355|B1|Baseline|Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
257077|NCT01369355|P6|Participant Flow|UST-I-nonRsp - UST-90mg Subcutaneously (SC) Q8W Maintenance|Participants (who were not in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab 90 mg SC on entry into maintenance followed by Ustekinumab 90 mg SC q8w beginning at Week 8 of maintenance (if in response).
257078|NCT01369355|P5|Participant Flow|PBO-I-nonRsp - UST-130mg Intravenous/90mg SC Q12W Maintenance|Participants (who were not in clinical response to placebo IV at Week 8 of an induction study) received Ustekinumab 130 mg IV on entry into maintenance followed by Ustekinumab 90 mg SC q12 weeks beginning at Week 8 of maintenance (if in response).
257079|NCT01369355|P4|Participant Flow|Placebo (PBO)-I-Rsp - PBO Maintenance|Participants (who were in clinical response to placebo IV at Week 8 of an induction study) received placebo SC q4w in the maintenance study.
257080|NCT01369355|P3|Participant Flow|UST-I-Rsp-UST-90 mg Q8W Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study.
257081|NCT01369355|P2|Participant Flow|UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 milligrams (mg) q12w in the maintenance study.
257082|NCT01369355|P1|Participant Flow|Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
257083|NCT01369355|O3|Outcome|Ustekinumab 90 mg SC q8w|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study.
257084|NCT01369355|O2|Outcome|Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q12w in the maintenance study.
257085|NCT01369355|O1|Outcome|Placebo Subcutaneously (SC)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
257086|NCT01369355|O3|Outcome|Ustekinumab 90 mg SC q8w|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study.
257087|NCT01369355|O2|Outcome|Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q12w in the maintenance study.
257088|NCT01369355|O1|Outcome|Placebo Subcutaneously (SC)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
257089|NCT01369355|O3|Outcome|Ustekinumab 90 mg SC q8w|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study.
257090|NCT01369355|O2|Outcome|Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q12w in the maintenance study.
261079|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
257091|NCT01369355|O1|Outcome|Placebo Subcutaneously (SC)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
257092|NCT01369355|O3|Outcome|Ustekinumab 90 mg SC q8w|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study.
257093|NCT01369355|O2|Outcome|Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q12w in the maintenance study.
257094|NCT01369355|O1|Outcome|Placebo Subcutaneously (SC)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
257095|NCT01369355|O3|Outcome|Ustekinumab 90 mg SC q8w|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study.
257096|NCT01369355|O2|Outcome|Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q12w in the maintenance study.
257097|NCT01369355|O1|Outcome|Placebo Subcutaneously (SC)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
257098|NCT01369355|E9|Reported Event|UST IV-I-nonRsp - UST-90 mg SC Q8W Maintenance|Participants (who were not in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab 90 mg SC on entry into maintenance followed by Ustekinumab 90 mg SC q8w beginning at Week 8 of maintenance (if in response); not randomized.
257099|NCT01369355|E8|Reported Event|PBO-I-nonRsp- UST-130mg Intravenous/90mg SC Q12W Maintenance|Participants (who were not in clinical response to placebo IV at Week 8 of an induction study) received Ustekinumab 130 mg IV on entry into maintenance followed by Ustekinumab 90 mg SC q12 weeks beginning at Week 8 of maintenance (if in response); not randomized.
257100|NCT01369355|E7|Reported Event|Placebo (PBO)-I-Rsp PBO Maintenance|Participants (who were in clinical response to placebo IV at Week 8 of an induction study) received placebo SC; not randomized.
257101|NCT01369355|E6|Reported Event|UST IV-I-Rsp-UST-90mg Maintenance-UST-90mg SC Q8W Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab SC 90 mg q8 weeks and remained on ustekinumab 90 mg q8w upon loss of response (includes events from the time of loss of response onward).
257102|NCT01369355|E5|Reported Event|UST-I-Rsp-UST 90 mg SC Q8W Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab SC 90 mg q8w (includes events up to the time of loss of response).
257103|NCT01369355|E4|Reported Event|UST-I-Rsp-UST 90 mg SC Q12W/Q8W Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab SC 90 mg q12w and had dose adjustment to Ustekinumab SC 90 mg q8w in the maintenance study (includes events from the time of loss of response onward).
257104|NCT01369355|E3|Reported Event|UST-I-Rsp-UST 90 mg SC Every 12 Weeks (Q12W) Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab SC 90 milligrams (mg) q12w in the maintenance study (includes events up to the time of loss of response).
257105|NCT01369355|E2|Reported Event|UST -I-Rsp -PBO Maintenance -UST-90mg SC Q8W- Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) received placebo SC and had dose adjustment to Ustekinumab SC 90 mg q8w (includes events from the time of loss of response onward).
257106|NCT01369355|E1|Reported Event|Ustekinumab Induction Responders(USTIRsp) Placebo Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) received placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study (includes events up to the time of loss of response).
257107|NCT01369342|B4|Baseline|Total|Total of all reporting groups
257108|NCT01369342|B3|Baseline|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
257109|NCT01369342|B2|Baseline|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
257110|NCT01369342|B1|Baseline|Placebo IV|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
257111|NCT01369342|P3|Participant Flow|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
257112|NCT01369342|P2|Participant Flow|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
257113|NCT01369342|P1|Participant Flow|Placebo IV|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
257114|NCT01369342|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
257115|NCT01369342|O2|Outcome|Ustekinumab 130 mg|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
257116|NCT01369342|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
257117|NCT01369342|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
257118|NCT01369342|O2|Outcome|Ustekinumab 130 mg|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
257120|NCT01369342|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
257121|NCT01369342|O2|Outcome|Ustekinumab 130 mg|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
257122|NCT01369342|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
257123|NCT01369342|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
257124|NCT01369342|O2|Outcome|Ustekinumab 130 mg|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
257125|NCT01369342|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
257126|NCT01369342|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
257127|NCT01369342|O2|Outcome|Ustekinumab 130 mg|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
257128|NCT01369342|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
257129|NCT01369342|E3|Reported Event|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants received a single tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
257130|NCT01369342|E2|Reported Event|Ustekinumab 130 Milligram (mg)|Participants received single dose of ustekinumab 130 milligram (mg) IV at week 0.
257131|NCT01369342|E1|Reported Event|Placebo IV|Participants received single dose of Placebo Intravenous (IV) infusion at week 0.
257132|NCT01369329|B4|Baseline|Total|Total of all reporting groups
257133|NCT01369329|B3|Baseline|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
257134|NCT01369329|B2|Baseline|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
257135|NCT01369329|B1|Baseline|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
257136|NCT01369329|P3|Participant Flow|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
257137|NCT01369329|P2|Participant Flow|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
257138|NCT01369329|P1|Participant Flow|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
257139|NCT01369329|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
257140|NCT01369329|O2|Outcome|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
257141|NCT01369329|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
257142|NCT01369329|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
257143|NCT01369329|O2|Outcome|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
257144|NCT01369329|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
257145|NCT01369329|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
257146|NCT01369329|O2|Outcome|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
257147|NCT01369329|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
257148|NCT01369329|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
257149|NCT01369329|O2|Outcome|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
257150|NCT01369329|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
257182|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
257151|NCT01369329|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
257152|NCT01369329|O2|Outcome|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
257153|NCT01369329|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
257154|NCT01369329|E3|Reported Event|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants received tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
257155|NCT01369329|E2|Reported Event|Ustekinumab 130 Milligram (mg)|Participants received a single dose of ustekinumab 130 milligram (mg) IV at week 0.
257156|NCT01369329|E1|Reported Event|Placebo|Participants received a single dose of Placebo Intravenous (IV) infusion at week 0.
257157|NCT01369225|B7|Baseline|Total|Total of all reporting groups
257158|NCT01369225|B6|Baseline|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
257159|NCT01369225|B5|Baseline|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
257160|NCT01369225|B4|Baseline|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
257161|NCT01369225|B3|Baseline|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
257162|NCT01369225|B2|Baseline|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
257163|NCT01369225|B1|Baseline|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
257164|NCT01369225|P6|Participant Flow|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
257165|NCT01369225|P5|Participant Flow|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
257166|NCT01369225|P4|Participant Flow|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
257167|NCT01369225|P3|Participant Flow|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
257168|NCT01369225|P2|Participant Flow|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
257169|NCT01369225|P1|Participant Flow|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
257170|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
257171|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
257172|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
257173|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
257174|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
257175|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
257176|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
257177|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
257178|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
257179|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
257180|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
257181|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
257278|NCT01368965|O1|Outcome|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52)
257183|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
257184|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
257185|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
257186|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
257187|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
257188|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
257189|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
257190|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
257191|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
257192|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
257193|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
257194|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
257195|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
257196|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
257197|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
257198|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
257199|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
257200|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
257201|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
257202|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
257203|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
257204|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
257205|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
257206|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
257207|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
257208|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
257209|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
257210|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
257211|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
257212|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
257213|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
257214|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
257215|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
257216|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
257217|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
257218|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
257219|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
257220|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
257221|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
257222|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
257223|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
257224|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
257225|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
257226|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
257227|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
257228|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
257229|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
257230|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
257231|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
257232|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
257233|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
257234|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
257235|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
257236|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
257237|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
257238|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
257239|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
257240|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
257241|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
257242|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
257243|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
257244|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
257245|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
257246|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
257247|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
257248|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
257249|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
257250|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
257251|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
257252|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
257253|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
257254|NCT01369225|E6|Reported Event|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
257255|NCT01369225|E5|Reported Event|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
257256|NCT01369225|E4|Reported Event|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
257257|NCT01369225|E3|Reported Event|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
257258|NCT01369225|E2|Reported Event|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
257259|NCT01369225|E1|Reported Event|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
257260|NCT01369108|B1|Baseline|All Participants|"Each enrolled patient possessed two teeth that met the inclusion criteria. Of these, 120 teeth, 60 were allocated to the comparator group (Filtek Supreme Ultra Universal restorative) and 60 were allocated to the experimental group (Filtek Supreme Ultra Flowable.~Flowable composite: Restoration of small Class V and I cavities in molar and premolar teeth~Conventional composite restorative: Restoration of small Class V and I cavities in molar and premolar teeth"
257261|NCT01369108|P1|Participant Flow|All Participants|"Each enrolled patient possessed two teeth that met the inclusion criteria. Of these, 120 teeth, 60 were allocated to the comparator group (Filtek Supreme Ultra Universal restorative) and 60 were allocated to the experimental group (Filtek Supreme Ultra Flowable.~Flowable composite: Restoration of small Class V and I cavities in molar and premolar teeth~Conventional composite restorative: Restoration of small Class V and I cavities in molar and premolar teeth"
257262|NCT01369108|O2|Outcome|Conventional Composite|"Highly filled conventional composite restorative~Conventional composite restorative: Restoration of small Class V and I cavities in molar and premolar teeth"
257263|NCT01369108|O1|Outcome|Flowable Composite|"Flowable composite~Flowable composite: Restoration of small Class V and I cavities in molar and premolar teeth"
257264|NCT01369108|O2|Outcome|Conventional Composite|"Highly filled conventional composite restorative~Conventional composite restorative: Restoration of small Class V and I cavities in molar and premolar teeth"
257265|NCT01369108|O1|Outcome|Flowable Composite|"Flowable composite~Flowable composite: Restoration of small Class V and I cavities in molar and premolar teeth"
257266|NCT01369108|E1|Reported Event|All Participants|"Each enrolled patient possessed two teeth that met the inclusion criteria. Of these, 120 teeth, 60 were allocated to the comparator group (Filtek Supreme Ultra Universal restorative) and 60 were allocated to the experimental group (Filtek Supreme Ultra Flowable.~Flowable composite: Restoration of small Class V and I cavities in molar and premolar teeth~Conventional composite restorative: Restoration of small Class V and I cavities in molar and premolar teeth"
257267|NCT01369030|B1|Baseline|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
257268|NCT01369030|P1|Participant Flow|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
257269|NCT01369030|O1|Outcome|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
257270|NCT01369030|O1|Outcome|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
257271|NCT01369030|O1|Outcome|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
257272|NCT01369030|E1|Reported Event|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
257273|NCT01368965|B1|Baseline|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52)
257274|NCT01368965|P1|Participant Flow|Treated Subjects|All treated study subjects received a full face Ulthera® treatment.
257275|NCT01368965|O1|Outcome|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52).
257276|NCT01368965|O1|Outcome|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52)
257277|NCT01368965|O1|Outcome|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52)
261080|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
257279|NCT01368965|O1|Outcome|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52)
257280|NCT01368965|O1|Outcome|Treated Subjects|All treated study subjects received a full face Ulthera® treatment.
257281|NCT01368965|E1|Reported Event|Enrolled Subjects|Includes all subjects enrolled, including 52 treated subjects and 2 non-treated subjects who withdrew consent prior to treatment.
257282|NCT01368900|B1|Baseline|Treated Subjects|All study subjects received an Ulthera treatment to the upper face.
257283|NCT01368900|P1|Participant Flow|Treated Subjects|"The FWCS, a 9 point scale used to classify wrinkle severity, was used to qualify subjects for study participation.~Score 1-3 = Fine wrinkles; 4-6 = Fine to moderate-depth wrinkles, moderate number of lines; 7-9 = Fine to deep wrinkles, Numerous lines with or without redundant skin folds.~All study subjects received an Ulthera treatment to the upper face."
257284|NCT01368900|O1|Outcome|Treated Subjects|All study subjects received an Ulthera treatment to the upper face.
257285|NCT01368900|O1|Outcome|Treated Subjects|All study subjects received an Ulthera treatment to the upper face.
257286|NCT01368900|O1|Outcome|Subjects Treated|All study subjects received an Ulthera treatment to the upper face.
257287|NCT01368900|O1|Outcome|Subjects Treated|All study subjects received an Ulthera treatment to the upper face.
257288|NCT01368900|O1|Outcome|Subjects Treated|All study subjects received an Ulthera treatment to the upper face.
257289|NCT01368900|O1|Outcome|Subjects Treated|All study subject received an Ulthera treatment to the upper face.
257290|NCT01368900|O1|Outcome|Subjects Treated|All study subjects received an Ulthera treatment to the upper face.
257291|NCT01368900|E1|Reported Event|Treated Subjects|All study subjects received an Ulthera treatment to the upper face.
257292|NCT01368874|B4|Baseline|Total|Total of all reporting groups
257293|NCT01368874|B3|Baseline|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
257294|NCT01368874|B2|Baseline|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
257295|NCT01368874|B1|Baseline|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
257296|NCT01368874|P3|Participant Flow|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
257297|NCT01368874|P2|Participant Flow|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
257298|NCT01368874|P1|Participant Flow|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
257299|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
257300|NCT01368874|O4|Outcome|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
257301|NCT01368874|O3|Outcome|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
257302|NCT01368874|O2|Outcome|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region.
257303|NCT01368874|O1|Outcome|All Subjects Treated|Treated subjects completing a 180 day post-treatment visit.
257304|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
257305|NCT01368874|O4|Outcome|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
257306|NCT01368874|O3|Outcome|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
257307|NCT01368874|O2|Outcome|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
257308|NCT01368874|O1|Outcome|All Subjects Treated|Treated subjects completing a 90 day post-treatment visit.
257309|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
257310|NCT01368874|O4|Outcome|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
257311|NCT01368874|O3|Outcome|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
257312|NCT01368874|O2|Outcome|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
257313|NCT01368874|O1|Outcome|All Subjects Treated|Treated subjects completing a 60 day post-treatment visit.
257314|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions. Twenty-nine (29) participants completed the 180-day study visit.
257315|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) participants completed the 180-day study visit.
257316|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the 180-day study visit.
257317|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy®® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-one (31) participants completed the 180-day study visit.
257318|NCT01368874|O1|Outcome|All Subjects Treated|Sixty (60) of 64 treated participants completed the 180-day study visit.
257319|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions. Twenty-nine (29) participants completed the 90-day study visit.
258823|NCT01363700|E4|Reported Event|Olopatadine Ophthalmic Solution Period2|Count unit was defined each eye.
257320|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) participants completed the 90-day study visit.
257321|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the 90-day study visit.
257322|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy®® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-two (32) participants completed the 90-day study visit.
257323|NCT01368874|O1|Outcome|All Subjects Treated|Sixty-one (61) of 64 treated participants completed the 90-day study visit.
257324|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions. Twenty-nine (29) participants completed the 180-day study visit.
257325|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) participants completed the 180-day study visit.
257326|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the study visit.
257327|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy®® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-one (31) participants completed the 180-day study visit.
257328|NCT01368874|O1|Outcome|All Subjects Treated|Sixty(60) of 64 treated participants completed the 180-day study visit.
257329|NCT01368874|O4|Outcome|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
257330|NCT01368874|O3|Outcome|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
257331|NCT01368874|O2|Outcome|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
257332|NCT01368874|O1|Outcome|All Subjects Treated|Sixty-four 64) treated participants' assessment of pain was completed during the Ulthera® treatment.
257333|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular, and lower neck regions.
257334|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions.
257335|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental,submandibular,and lower neck regions.
257336|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region.
257337|NCT01368874|O1|Outcome|All Subjects Treated|A data set of 42 of the 61 participants were re-analyzed. Data were removed for 19 participants whose pre-treatment and/or post-treatment photos were of poor photo quality, i.e., poor lighting, poor focus, poor positioning, creating the potential for biasing the masked assessment results.
257338|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions. Twenty-nine (29) participants completed the 90-day study visit.
257339|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four(24) participants completed the 90-day study visit.
257340|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the 90-day study visit.
257341|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy®® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-two (32) participants completed the 90-day study visit.
257342|NCT01368874|O1|Outcome|All Subjects Treated|Sixty-one (61) of 64 treated participants completed the 90-day study visit.
257343|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions. Thirty (30) participants completed the 60-day study visit.
257344|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-five (25) participants completed the 60-day study visit.
257345|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the 60-day study visit.
257346|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy®® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-one (31) participants completed the 60-day study visit.
257347|NCT01368874|O1|Outcome|All Subjects Treated|Sixty-one (61) of 64 treated participants completed the 60- visit.
257348|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
257349|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) of 25 participants completed the 90-day study visit; 1 participant was lost-to-follow-up
257350|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face, submental, submandibular, and lower neck regions.
257351|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-two (32) of 34 Group A participants completed the 90-day study visit; two participants were lost-to-follow-up.
257445|NCT01368432|O2|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram intervention and represents their anxiety score.
257352|NCT01368874|O1|Outcome|All Subjects Treated|Sixty-one (61) of 64 treated participants completed the 90-day study visit; 2 participants (1 each from Groups A and C)were lost-to-follow-up, 1 participant(Group A) missed the visit.
257353|NCT01368874|E4|Reported Event|Groups B/C|
257354|NCT01368874|E3|Reported Event|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
257355|NCT01368874|E2|Reported Event|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
257356|NCT01368874|E1|Reported Event|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
257357|NCT01368835|B1|Baseline|Ulthera Treatment|Treatment to the lower face and submental region.
257358|NCT01368835|P1|Participant Flow|Ulthera Treatment|Subjects will receive one dual-depth focused ultrasound treatment to their lower face and submental regions.
257359|NCT01368835|O1|Outcome|Ulthera Treatment|Treatment to the lower face and submental region.
257360|NCT01368835|O1|Outcome|Ulthera Treatment|Treatment to the lower face and submental region.
257361|NCT01368835|O1|Outcome|Ulthera Treatment|Treatment to the lower face and submental region.
257362|NCT01368835|O1|Outcome|Ulthera Treatment|Subjects who received one focused ultrasound treatment to the lower face and submental regions using the Ultera System.
257363|NCT01368835|E1|Reported Event|Ulthera Treatment|Treatment to the lower face and submental region.
257364|NCT01368809|B3|Baseline|Total|Total of all reporting groups
257365|NCT01368809|B2|Baseline|Saline Solution|"Saline Solution 2 ml at induction, 1-2 ml boluses as needed~Fentanyl: Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed"
257366|NCT01368809|B1|Baseline|Fentanyl|"Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed~Saline: 2 ml at induction 1-2 ml boluses as needed"
257367|NCT01368809|P2|Participant Flow|Saline Solution|Saline Solution 2 ml at induction, 1-2 ml boluses as needed
257368|NCT01368809|P1|Participant Flow|Fentanyl|Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed
257369|NCT01368809|O2|Outcome|Saline Solution|Saline Solution 2 ml at induction, 1-2 ml boluses as needed
257370|NCT01368809|O1|Outcome|Fentanyl|Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed
257371|NCT01368809|O2|Outcome|Saline Solution|Saline Solution 2 ml at induction, 1-2 ml boluses as needed
257372|NCT01368809|O1|Outcome|Fentanyl|Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed
257373|NCT01368809|O2|Outcome|Saline Solution|"Saline Solution 2 ml at induction, 1-2 ml boluses as needed~Fentanyl: Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed"
257374|NCT01368809|O1|Outcome|Fentanyl|"Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed~Saline: 2 ml at induction 1-2 ml boluses as needed"
257375|NCT01368809|E2|Reported Event|Saline Solution|"Saline Solution 2 ml at induction, 1-2 ml boluses as needed~Fentanyl: Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed"
257376|NCT01368809|E1|Reported Event|Fentanyl|"Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed~Saline: 2 ml at induction 1-2 ml boluses as needed"
257377|NCT01368653|B3|Baseline|Total|Total of all reporting groups
257378|NCT01368653|B2|Baseline|Standard Treatment+Practice Quitting|"In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.~Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
257379|NCT01368653|B1|Baseline|Standard Treatment|"In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking~Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
257380|NCT01368653|P2|Participant Flow|Standard Treatment+Practice Quitting|"In this arm, participants receive standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.~Standard treatment+practice quitting: This intervention includes standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
257381|NCT01368653|P1|Participant Flow|Standard Treatment|"In this arm, smokers receive a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking~Standard treatment: Standard treatment includes a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
257382|NCT01368653|O4|Outcome|Advice and Encouragement Only|Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a very-low-nicotine-cigarette condition (n=20) at the 4-week follow-up. In this control condition, smokers received advice and encouragement to try to stop smoking again at the 4-week follow-up after they slipped (returned to smoking) during a stop smoking attempt.
257383|NCT01368653|O3|Outcome|Very Low Nicotine Cigarettes|"Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a smoking cessation advice and encouragement control condition (n=20) at the 4-week follow-up. In this condition, smokers received a 6-week supply of cigarettes that contained tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine. This treatment was designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking~Very low nicotine cigarettes: Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These were to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks."
257384|NCT01368653|O2|Outcome|Standard Treatment+Practice Quitting|"In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.~Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
257385|NCT01368653|O1|Outcome|Standard Treatment|"In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking~Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
257386|NCT01368653|O4|Outcome|Advice and Encouragement Only|Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a very-low-nicotine-cigarette condition (n=20) at the 4-week follow-up. In this control condition, smokers received advice and encouragement to try to stop smoking again at the 4-week follow-up after they slipped (returned to smoking) during a stop smoking attempt.
257387|NCT01368653|O3|Outcome|Very Low Nicotine Cigarettes|"Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a smoking cessation advice and encouragement control condition (n=20) at the 4-week follow-up. In this condition, smokers received a 6-week supply of cigarettes that contained tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine. This treatment was designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking~Very low nicotine cigarettes: Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These were to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks."
257388|NCT01368653|O2|Outcome|Standard Treatment+Practice Quitting|"In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.~Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
257389|NCT01368653|O1|Outcome|Standard Treatment|"In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking~Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
257390|NCT01368653|O2|Outcome|Standard Treatment+Practice Quitting|"In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involved practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.~Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involved practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
257391|NCT01368653|O1|Outcome|Standard Treatment|"In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking~Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
257392|NCT01368653|E4|Reported Event|Advice and Encouragement Only|Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a very-low-nicotine-cigarette condition (n=20) at the 4-week follow-up. In this control condition, smokers received advice and encouragement to try to stop smoking again at the 4-week follow-up after they slipped (returned to smoking) during a stop smoking attempt.
257393|NCT01368653|E3|Reported Event|Very Low Nicotine Cigarettes|"Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a smoking cessation advice and encouragement control condition (n=20) at the 4-week follow-up. In this condition, smokers received a 6-week supply of cigarettes that contained tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine. This treatment was designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking~Very low nicotine cigarettes: Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These were to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks."
257394|NCT01368653|E2|Reported Event|Standard Treatment+Practice Quitting|"In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.~Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
257395|NCT01368653|E1|Reported Event|Standard Treatment|"In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking~Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
257396|NCT01368536|B4|Baseline|Total|Total of all reporting groups
258824|NCT01363700|E3|Reported Event|Epinastine (DE-114) Ophthalmic Solution Period2|Count unit was defined each eye.
257397|NCT01368536|B3|Baseline|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
257398|NCT01368536|B2|Baseline|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
257399|NCT01368536|B1|Baseline|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
257400|NCT01368536|P3|Participant Flow|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
257401|NCT01368536|P2|Participant Flow|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
257402|NCT01368536|P1|Participant Flow|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
257403|NCT01368536|O3|Outcome|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
257404|NCT01368536|O2|Outcome|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
257405|NCT01368536|O1|Outcome|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
257406|NCT01368536|O3|Outcome|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
257407|NCT01368536|O2|Outcome|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
257408|NCT01368536|O1|Outcome|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
257409|NCT01368536|O3|Outcome|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
257410|NCT01368536|O2|Outcome|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
257411|NCT01368536|O1|Outcome|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
257412|NCT01368536|O3|Outcome|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
257446|NCT01368432|O1|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention and represents their anxiety score.
258825|NCT01363700|E2|Reported Event|Placebo Ophthalmic Solution Period1|Count unit was defined each eye.
257413|NCT01368536|O2|Outcome|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
257414|NCT01368536|O1|Outcome|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
257415|NCT01368536|O2|Outcome|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
257416|NCT01368536|O1|Outcome|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
257417|NCT01368536|O2|Outcome|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
257418|NCT01368536|O1|Outcome|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
257419|NCT01368536|E3|Reported Event|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
257420|NCT01368536|E2|Reported Event|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
257421|NCT01368536|E1|Reported Event|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
257422|NCT01368432|B3|Baseline|Total|Total of all reporting groups
257423|NCT01368432|B2|Baseline|Escitalopram|Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
257424|NCT01368432|B1|Baseline|Placebo|The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.
257425|NCT01368432|P2|Participant Flow|Escitalopram|Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
257426|NCT01368432|P1|Participant Flow|Placebo|The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.
257427|NCT01368432|O2|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram intervention.
257428|NCT01368432|O1|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention.
257429|NCT01368432|O2|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram intervention.
257430|NCT01368432|O1|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention.
257431|NCT01368432|O2|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram intervention.
257432|NCT01368432|O1|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention.
257433|NCT01368432|O2|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram intervention.
257434|NCT01368432|O1|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention.
257435|NCT01368432|O2|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram intervention.
257436|NCT01368432|O1|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention.
257437|NCT01368432|O2|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram intervention.
257438|NCT01368432|O1|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention.
257439|NCT01368432|O2|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram intervention.
257440|NCT01368432|O1|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention.
257441|NCT01368432|O2|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram intervention.
257442|NCT01368432|O1|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention.
257443|NCT01368432|O2|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram intervention and represents their anxiety score.
257444|NCT01368432|O1|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention and represents their anxiety score.
257447|NCT01368432|O2|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram and represents their global health at 12 weeks.
257448|NCT01368432|O1|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention and represents their global health score at 12 weeks
257449|NCT01368432|O2|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram and represents their baseline global health
257450|NCT01368432|O1|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention and represents their baseline global health.
257451|NCT01368432|O2|Outcome|Treatment Group MADRS 12 Weeks|This group consists of participants who received escitalopram and their level of depression as assessed by the MADRS scoring system.
257452|NCT01368432|O1|Outcome|Placebo Group MADRS 12 Weeks|This group consists of participants who received the placebo intervention and their level of depression as assessed by the MADRS scoring system.
257453|NCT01368432|O2|Outcome|Treatment Group Baseline|Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
257454|NCT01368432|O1|Outcome|Placebo Group Baseline|The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.
257455|NCT01368432|E2|Reported Event|Escitalopram|Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week.
257456|NCT01368432|E1|Reported Event|Placebo|The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.
257457|NCT01368406|B3|Baseline|Total|Total of all reporting groups
257458|NCT01368406|B2|Baseline|Treatment as Usual|treatment as usual received by the patients
257459|NCT01368406|B1|Baseline|Wellness Program|12-week weight management intervention in patients with severe mental disorders. In the 1-hour weekly group sessions topics like dietary choices, lifestyle, physical activity and self-esteem were discussed with outpatients and their relatives
257460|NCT01368406|P2|Participant Flow|Treatment as Usual|treatment as usual received by the patients
257461|NCT01368406|P1|Participant Flow|Wellness Program|12-week weight management intervention in patients with severe mental disorders. In the 1-hour weekly group sessions topics like dietary choices, lifestyle, physical activity and self-esteem were discussed with outpatients and their relatives
257462|NCT01368406|O2|Outcome|Treatment as Usual|treatment as usual received by the patients
257463|NCT01368406|O1|Outcome|Wellness Program|lifestyle intervention for 12 weeks
257464|NCT01368406|E2|Reported Event|Treatment as Usual|treatment as usual received by the patients
257465|NCT01368406|E1|Reported Event|Wellness Program|12-week weight management intervention in patients with severe mental disorders. In the 1-hour weekly group sessions topics like dietary choices, lifestyle, physical activity and self-esteem were discussed with outpatients and their relatives
257466|NCT01368276|B3|Baseline|Total|Total of all reporting groups
257467|NCT01368276|B2|Baseline|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ PFU/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
257468|NCT01368276|B1|Baseline|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
257469|NCT01368276|P2|Participant Flow|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ plaque forming units (PFU)/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
257470|NCT01368276|P1|Participant Flow|GM-CSF|Granulocyte macrophage colony-stimulating factor (GM-CSF) was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
257471|NCT01368276|O2|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ PFU/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
257472|NCT01368276|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
257473|NCT01368276|O2|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ PFU/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
257474|NCT01368276|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
257475|NCT01368276|O2|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ PFU/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
257476|NCT01368276|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
257477|NCT01368276|E2|Reported Event|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ PFU/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
257478|NCT01368276|E1|Reported Event|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
257479|NCT01368263|B4|Baseline|Total|Total of all reporting groups
257480|NCT01368263|B3|Baseline|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
257481|NCT01368263|B2|Baseline|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
257482|NCT01368263|B1|Baseline|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
257483|NCT01368263|P3|Participant Flow|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
257484|NCT01368263|P2|Participant Flow|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
257485|NCT01368263|P1|Participant Flow|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
257486|NCT01368263|O3|Outcome|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
257487|NCT01368263|O2|Outcome|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
257488|NCT01368263|O1|Outcome|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
257489|NCT01368263|O3|Outcome|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
257692|NCT01367834|E2|Reported Event|Control|Subjects will receive no GH or placebo.
257490|NCT01368263|O2|Outcome|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
257491|NCT01368263|O1|Outcome|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
257492|NCT01368263|O3|Outcome|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
257493|NCT01368263|O2|Outcome|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
257494|NCT01368263|O1|Outcome|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
257495|NCT01368263|O3|Outcome|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
257496|NCT01368263|O2|Outcome|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
257497|NCT01368263|O1|Outcome|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
257498|NCT01368263|O3|Outcome|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
257499|NCT01368263|O2|Outcome|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
257500|NCT01368263|O1|Outcome|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
257501|NCT01368263|E3|Reported Event|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
257502|NCT01368263|E2|Reported Event|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
257503|NCT01368263|E1|Reported Event|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
257504|NCT01368211|B3|Baseline|Total|Total of all reporting groups
257505|NCT01368211|B2|Baseline|Reference First, Then Mirasol|"This study arm will receive first a reference untreated 2-4-day-old platelet transfusion and then a Mirasol treated 2-4-day-old platelet transfusion (Reference-Mirasol sequence).~Mirasol-treated Platelets: Mirasol-treated platelet units with:~Platelet yield between 2.4x10e11 and 4.5x10e11~Plasma carryover of >32%~Cell count > 800x103/µL"
257506|NCT01368211|B1|Baseline|Mirasol First, Then Reference|"This study arm will receive first a Mirasol treated 2-4-day-old platelet transfusion and then a reference 2-4-day-old platelet transfusion (Mirasol-Reference sequence).~Mirasol-treated Platelets: Mirasol-treated platelet units with:~Platelet yield between 2.4x10e11 and 4.5x10e11~Plasma carryover of >32%~Cell count > 800x103/µL"
258826|NCT01363700|E1|Reported Event|Epinastine (DE-114) Ophthalmic Solution Period1|Count unit was defined each eye.
257507|NCT01368211|P2|Participant Flow|Reference First, Then Mirasol|"This study arm received first a reference untreated 2-4-day-old platelet transfusion and then a Mirasol treated 2-4-day-old platelet transfusion (Reference-Mirasol sequence).~Mirasol-treated Platelets: Mirasol-treated platelet units with:~Platelet yield between 2.4x10e11 and 4.5x10e11~Plasma carryover of >32%~Cell count > 800x103/µL"
257508|NCT01368211|P1|Participant Flow|Mirasol First, Then Reference|"This study arm received first a Mirasol treated 2-4-day-old platelet transfusion and then a reference 2-4-day-old platelet transfusion (Mirasol-Reference sequence).~Mirasol-treated Platelets: Mirasol-treated platelet units with:~Platelet yield between 2.4x10e11 and 4.5x10e11~Plasma carryover of >32%~Cell count > 800x103/µL"
257509|NCT01368211|O2|Outcome|Untreated Reference|Untreated 2-4-day old platelet transfusion
257510|NCT01368211|O1|Outcome|Mirasol|Mirasol-treated 2-4-day old platelet transfusion
257511|NCT01368211|O2|Outcome|Untreated Reference|Untreated 2-4-day old platelet transfusion
257512|NCT01368211|O1|Outcome|Mirasol|Mirasol-treated 2-4-day old platelet transfusion
257513|NCT01368211|E2|Reported Event|Untreated Reference Platelets|Patients that received an untreated reference2-4-day-old platelet transfusion.
257514|NCT01368211|E1|Reported Event|Mirasol-treated Platelets|Patients that received a Mirasol treated 2-4-day-old platelet transfusion.
257515|NCT01368185|B1|Baseline|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
257516|NCT01368185|P1|Participant Flow|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
257517|NCT01368185|O1|Outcome|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
257518|NCT01368185|O1|Outcome|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
257519|NCT01368185|O1|Outcome|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
257520|NCT01368185|O1|Outcome|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
257521|NCT01368185|E1|Reported Event|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
257522|NCT01368081|B14|Baseline|Total|Total of all reporting groups
257523|NCT01368081|B13|Baseline|Glinide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
257524|NCT01368081|B12|Baseline|Glinide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
257525|NCT01368081|B11|Baseline|DPP−IV Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
257526|NCT01368081|B10|Baseline|DPP−IV Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
257527|NCT01368081|B9|Baseline|Alpha Glucosidase Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
257528|NCT01368081|B8|Baseline|Alpha Glucosidase Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
257529|NCT01368081|B7|Baseline|Thiazolidinedione: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
257530|NCT01368081|B6|Baseline|Thiazolidinedione: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
257531|NCT01368081|B5|Baseline|Biguanide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
257532|NCT01368081|B4|Baseline|Biguanide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
257533|NCT01368081|B3|Baseline|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
257534|NCT01368081|B2|Baseline|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
257535|NCT01368081|B1|Baseline|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
257536|NCT01368081|P13|Participant Flow|Glinide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
257537|NCT01368081|P12|Participant Flow|Glinide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
257538|NCT01368081|P11|Participant Flow|DPP−IV Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of dipeptidyl peptidase IV (DPP−IV) inhibitor
257539|NCT01368081|P10|Participant Flow|DPP−IV Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of dipeptidyl peptidase IV (DPP−IV) inhibitor
257540|NCT01368081|P9|Participant Flow|Alpha Glucosidase Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
257541|NCT01368081|P8|Participant Flow|Alpha Glucosidase Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
257542|NCT01368081|P7|Participant Flow|Thiazolidinedione: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
257543|NCT01368081|P6|Participant Flow|Thiazolidinedione: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
257544|NCT01368081|P5|Participant Flow|Biguanide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
257545|NCT01368081|P4|Participant Flow|Biguanide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
257546|NCT01368081|P3|Participant Flow|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
257547|NCT01368081|P2|Participant Flow|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
257548|NCT01368081|P1|Participant Flow|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
257549|NCT01368081|O13|Outcome|Glinide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
257550|NCT01368081|O12|Outcome|Glinide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
257551|NCT01368081|O11|Outcome|DPP−IV Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
257552|NCT01368081|O10|Outcome|DPP−IV Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
257553|NCT01368081|O9|Outcome|Alpha Glucosidase Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
257554|NCT01368081|O8|Outcome|Alpha Glucosidase Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
257555|NCT01368081|O7|Outcome|Thiazolidinedione: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
257556|NCT01368081|O6|Outcome|Thiazolidinedione: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
257557|NCT01368081|O5|Outcome|Biguanide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
257558|NCT01368081|O4|Outcome|Biguanide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
257559|NCT01368081|O3|Outcome|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
257560|NCT01368081|O2|Outcome|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
257561|NCT01368081|O1|Outcome|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
257562|NCT01368081|O13|Outcome|Glinide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
257563|NCT01368081|O12|Outcome|Glinide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
257564|NCT01368081|O11|Outcome|DPP−IV Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
257565|NCT01368081|O10|Outcome|DPP−IV Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
257566|NCT01368081|O9|Outcome|Alpha Glucosidase Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
257567|NCT01368081|O8|Outcome|Alpha Glucosidase Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
257568|NCT01368081|O7|Outcome|Thiazolidinedione: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
257569|NCT01368081|O6|Outcome|Thiazolidinedione: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
257570|NCT01368081|O5|Outcome|Biguanide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
257571|NCT01368081|O4|Outcome|Biguanide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
257572|NCT01368081|O3|Outcome|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
257573|NCT01368081|O2|Outcome|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
257574|NCT01368081|O1|Outcome|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
257575|NCT01368081|O13|Outcome|Glinide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
257576|NCT01368081|O12|Outcome|Glinide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
257577|NCT01368081|O11|Outcome|DPP−IV Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
258827|NCT01363661|B3|Baseline|Total|Total of all reporting groups
257578|NCT01368081|O10|Outcome|DPP−IV Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
257579|NCT01368081|O9|Outcome|Alpha Glucosidase Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
257580|NCT01368081|O8|Outcome|Alpha Glucosidase Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
257581|NCT01368081|O7|Outcome|Thiazolidinedione: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
257582|NCT01368081|O6|Outcome|Thiazolidinedione: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
257583|NCT01368081|O5|Outcome|Biguanide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
257584|NCT01368081|O4|Outcome|Biguanide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
257585|NCT01368081|O3|Outcome|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
257586|NCT01368081|O2|Outcome|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
257587|NCT01368081|O1|Outcome|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
257588|NCT01368081|E13|Reported Event|Glinide: Empa 25mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
257589|NCT01368081|E12|Reported Event|Glinide: Empa 10mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
257590|NCT01368081|E11|Reported Event|DPP-4 Inhibitor: Empa 25mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-4 inhibitor
257591|NCT01368081|E10|Reported Event|DPP-4 Inhibitor: Empa 10mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-4 inhibitor
257592|NCT01368081|E9|Reported Event|Alpha-GI: Empa 25mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha-GI
257593|NCT01368081|E8|Reported Event|Alpha-GI: Empa 10mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha-GI
257594|NCT01368081|E7|Reported Event|Thiazolidinedione: Empa 25mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
257595|NCT01368081|E6|Reported Event|Thiazolidinedione: Empa 10mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
257596|NCT01368081|E5|Reported Event|Biguanide: Empa 25mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
257597|NCT01368081|E4|Reported Event|Biguanide: Empa 10mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
257598|NCT01368081|E3|Reported Event|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
257599|NCT01368081|E2|Reported Event|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
257600|NCT01368081|E1|Reported Event|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
257601|NCT01368042|B1|Baseline|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
257602|NCT01368042|P1|Participant Flow|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
257603|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
257604|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
257605|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
257606|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
257607|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
257608|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
257609|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
257610|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
257611|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
257612|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
257613|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
257614|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
257615|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
257616|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
257617|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
257618|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
257619|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
257620|NCT01368042|E1|Reported Event|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible patients treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
257621|NCT01367886|B1|Baseline|Fesoterodine|Overactive bladder subjects took Fesoterodine 4 mg daily for 6 weeks.
257622|NCT01367886|P1|Participant Flow|Fesoterodine|"Females with overactive bladder symptoms were given Fesoterodine 4 mg. daily for six weeks.~Fesoterodine : Fesoterodine 4 mg. tablet by mouth daily for six weeks"
257623|NCT01367886|O1|Outcome|Fesoterodine|"Females with overactive bladder symptoms will be given fesoterodine 4 mg. daily for six weeks.~fesoterodine: Fesoterodine 4 mg. tablet by mouth daily for six weeks"
257624|NCT01367886|O1|Outcome|Fesoterodine|"Females with overactive bladder symptoms will be given fesoterodine 4 mg. daily for six weeks.~fesoterodine: Fesoterodine 4 mg. tablet by mouth daily for six weeks"
257625|NCT01367886|O1|Outcome|Fesoterodine|"Females with overactive bladder symptoms will be given fesoterodine 4 mg. daily for six weeks.~fesoterodine : Fesoterodine 4 mg. tablet by mouth daily for six weeks"
257626|NCT01367886|O1|Outcome|Fesoterodine|"Females with overactive bladder symptoms will be given fesoterodine 4 mg. daily for six weeks.~fesoterodine : Fesoterodine 4 mg. tablet by mouth daily for six weeks"
257627|NCT01367886|E1|Reported Event|Fesoterodine|"Females with overactive bladder symptoms will be given Fesoterodine 4 mg. daily for six weeks.~Fesoterodine : Fesoterodine 4 mg. tablet by mouth daily for six weeks"
257628|NCT01367860|B3|Baseline|Total|Total of all reporting groups
257629|NCT01367860|B2|Baseline|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
257630|NCT01367860|B1|Baseline|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
257631|NCT01367860|P2|Participant Flow|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
257632|NCT01367860|P1|Participant Flow|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
257633|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
257634|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
257635|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
257706|NCT01367704|E1|Reported Event|Control School|Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')
257636|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
257637|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
257638|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
257639|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
257640|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
257641|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
257642|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
257643|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
257644|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
257645|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
257646|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
257647|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
257648|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
257649|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
257650|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
257651|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
257652|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
257653|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
257654|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
257655|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
257656|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
257657|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
257658|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
257659|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
257660|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
257661|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
257662|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
257663|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
257664|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
257665|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
257666|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
257667|NCT01367860|E2|Reported Event|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
257668|NCT01367860|E1|Reported Event|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
257669|NCT01367834|B3|Baseline|Total|Total of all reporting groups
257670|NCT01367834|B2|Baseline|Control|Subjects will receive no GH or placebo.
257671|NCT01367834|B1|Baseline|Growth Hormone|"Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.~somatotropin: Subjects will receive 5 mg somatotropin (growth hormone) pens with cartridges. Subcutaneous injections are to be given every evening around bedtime. Dosing regimen: 50 mcg/kg/day to be adjusted at 4 month intervals to the closest 0.1 mg. Subjects will be given 12 months of treatment (from 12 to 24 months of life). Subjects will visit their pediatrician or pediatric endocrinologist at 4 and 8 months of life."
257672|NCT01367834|P2|Participant Flow|Control|Subjects will receive no GH or placebo.
257673|NCT01367834|P1|Participant Flow|Growth Hormone|"Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.~somatotropin: Subjects will receive 5 mg somatotropin (growth hormone) pens with cartridges. Subcutaneous injections are to be given every evening around bedtime. Dosing regimen: 50 mcg/kg/day to be adjusted at 4 month intervals to the closest 0.1 mg. Subjects will be given 12 months of treatment (from 12 to 24 months of life). Subjects will visit their pediatrician or pediatric endocrinologist at 4 and 8 months of life."
257674|NCT01367834|O2|Outcome|Control|No intervention
257675|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
257676|NCT01367834|O2|Outcome|Control|No intervention
257677|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
257678|NCT01367834|O2|Outcome|Control|No intervention
257679|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
257680|NCT01367834|O2|Outcome|Control|No intervention
257681|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
257682|NCT01367834|O2|Outcome|Control|No intervention
257683|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
257684|NCT01367834|O2|Outcome|Control|No intervention
257685|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
257686|NCT01367834|O2|Outcome|Control|No intervention
257687|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
257688|NCT01367834|O2|Outcome|Control|No intervention
257689|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
257690|NCT01367834|O2|Outcome|Control|No intervention
257691|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
257693|NCT01367834|E1|Reported Event|Growth Hormone|"Subjects in the somatotropin (growth hormone, GH) arm will receive GH injections from 12-24 months of life.~somatotropin: Subjects will receive 5 mg somatotropin (growth hormone) pens with cartridges. Subcutaneous injections are to be given every evening around bedtime. Dosing regimen: 50 mcg/kg/day to be adjusted at 4 month intervals to the closest 0.1 mg. Subjects will be given 12 months of treatment (from 12 to 24 months of life). Subjects will visit their pediatrician or pediatric endocrinologist at 4 and 8 months of life."
257694|NCT01367704|B3|Baseline|Total|Total of all reporting groups
257695|NCT01367704|B2|Baseline|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
257696|NCT01367704|B1|Baseline|Control School|Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')
257697|NCT01367704|P2|Participant Flow|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
257698|NCT01367704|P1|Participant Flow|Control School|Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')
257699|NCT01367704|O2|Outcome|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
257700|NCT01367704|O1|Outcome|Control School|"Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
257701|NCT01367704|O2|Outcome|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
257702|NCT01367704|O1|Outcome|Control School|"Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
257703|NCT01367704|O2|Outcome|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
257704|NCT01367704|O1|Outcome|Control School|"Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
257705|NCT01367704|E2|Reported Event|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
257707|NCT01367457|B4|Baseline|Total|Total of all reporting groups
257708|NCT01367457|B3|Baseline|MCL: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
257709|NCT01367457|B2|Baseline|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
257710|NCT01367457|B1|Baseline|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
257711|NCT01367457|P3|Participant Flow|MCL: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
257712|NCT01367457|P2|Participant Flow|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
257713|NCT01367457|P1|Participant Flow|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
257714|NCT01367457|O3|Outcome|MCC: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
257715|NCT01367457|O2|Outcome|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
257716|NCT01367457|O1|Outcome|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
257717|NCT01367457|O3|Outcome|MCC: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
257718|NCT01367457|O2|Outcome|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
257719|NCT01367457|O1|Outcome|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
257720|NCT01367457|O3|Outcome|MCC: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
257721|NCT01367457|O2|Outcome|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
257722|NCT01367457|O1|Outcome|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
257723|NCT01367457|O3|Outcome|MCC: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
257724|NCT01367457|O2|Outcome|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
257725|NCT01367457|O1|Outcome|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
257726|NCT01367457|O3|Outcome|MCC: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
257727|NCT01367457|O2|Outcome|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
257728|NCT01367457|O1|Outcome|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
257729|NCT01367457|E3|Reported Event|MCL: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
257730|NCT01367457|E2|Reported Event|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
257731|NCT01367457|E1|Reported Event|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
257732|NCT01367249|B3|Baseline|Total|Total of all reporting groups
257733|NCT01367249|B2|Baseline|Placebo|"One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution"
257734|NCT01367249|B1|Baseline|Bromfenac Ophthalmic Solution|"Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Bromfenac Ophthalmic Solution: Sterile ophthalmic solution"
257735|NCT01367249|P2|Participant Flow|Placebo|"One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution"
257736|NCT01367249|P1|Participant Flow|Bromfenac Ophthalmic Solution|"Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Bromfenac Ophthalmic Solution: Sterile ophthalmic solution"
257737|NCT01367249|O2|Outcome|Placebo|"One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution"
257738|NCT01367249|O1|Outcome|Bromfenac Ophthalmic Solution|"Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Bromfenac Ophthalmic Solution: Sterile ophthalmic solution"
257739|NCT01367249|O2|Outcome|Placebo|"One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution"
257740|NCT01367249|O1|Outcome|Bromfenac Ophthalmic Solution|"Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Bromfenac Ophthalmic Solution: Sterile ophthalmic solution"
257741|NCT01367249|E2|Reported Event|Placebo|"One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution"
257742|NCT01367249|E1|Reported Event|Bromfenac Ophthalmic Solution|"Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Bromfenac Ophthalmic Solution: Sterile ophthalmic solution"
257743|NCT01367158|B12|Baseline|Total|Total of all reporting groups
257744|NCT01367158|B11|Baseline|1ACWY|One dose of MenACWY vaccine followed by one dose of placebo in the primary study and one dose of Tdap in the current study
257745|NCT01367158|B10|Baseline|2 B|Two doses of rMenB vaccine in the primary study and one dose of Tdap in the current study
257746|NCT01367158|B9|Baseline|3 B|Two doses of rMenB vaccine in the primary study and one dose of the same vaccine in the current study
257747|NCT01367158|B8|Baseline|2ABCWYqOMV|Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of Tdap in the current study
257748|NCT01367158|B7|Baseline|3ABCWYqOMV|Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of the same vaccine in the current study
257749|NCT01367158|B6|Baseline|2ABCWY+OMV|Two doses MenABCWY+OMV vaccine in the primary study and one dose of Tdap in the current study
257750|NCT01367158|B5|Baseline|3ABCWY+OMV|Two doses MenABCWY+OMV vaccine in the primary study and one dose of the same vaccine in the current study
257751|NCT01367158|B4|Baseline|2ABx2CWY|Two doses of MenABx2CWY vaccine in the primary study and one dose of Tdap in the current study
257752|NCT01367158|B3|Baseline|3ABx2CWY|Two doses of MenABx2CWY vaccine in the primary study and one dose of the same vaccine in the current study
257753|NCT01367158|B2|Baseline|2ABCWY|Two doses of MenABCWY vaccine (no OMV) in the primary study and one dose of Tdap in the current study
257754|NCT01367158|B1|Baseline|3ABCWY|Two doses of MenABCWY vaccine (no outer membrane vesicle {OMV}) in the primary study and one dose of the same vaccine in the current study
257755|NCT01367158|P11|Participant Flow|1ACWY|One dose of MenACWY vaccine followed by one dose of placebo in the primary study and one dose of Tdap in the current study
257756|NCT01367158|P10|Participant Flow|2 B|Two doses of rMenB vaccine in the primary study and one dose of Tdap in the current study
257757|NCT01367158|P9|Participant Flow|3 B|Two doses of rMenB vaccine in the primary study and one dose of the same vaccine in the current study
257758|NCT01367158|P8|Participant Flow|2ABCWYqOMV|Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of Tdap in the current study
257759|NCT01367158|P7|Participant Flow|3ABCWYqOMV|Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of the same vaccine in the current study
257760|NCT01367158|P6|Participant Flow|2ABCWY+OMV|Two doses MenABCWY+OMV vaccine in the primary study and one dose of Tdap in the current study
257761|NCT01367158|P5|Participant Flow|3ABCWY+OMV|Two doses MenABCWY+OMV vaccine in the primary study and one dose of the same vaccine in the current study
257762|NCT01367158|P4|Participant Flow|2ABx2CWY|Two doses of MenABx2CWY vaccine in the primary study and one dose of Tdap in the current study
257763|NCT01367158|P3|Participant Flow|3ABx2CWY|Two doses of MenABx2CWY vaccine in the primary study and one dose of the same vaccine in the current study
257764|NCT01367158|P2|Participant Flow|2ABCWY|Two doses of MenABCWY vaccine (no OMV) in the primary study and one dose of Tdap in the current study
257765|NCT01367158|P1|Participant Flow|3ABCWY|Two doses of MenABCWY vaccine (no outer membrane vesicle {OMV}) in the primary study and one dose of the same vaccine in the current study
257766|NCT01367158|O11|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
257767|NCT01367158|O10|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
257768|NCT01367158|O9|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
257769|NCT01367158|O8|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
257770|NCT01367158|O7|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
258828|NCT01363661|B2|Baseline|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
257771|NCT01367158|O6|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
257772|NCT01367158|O5|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
257773|NCT01367158|O4|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
257774|NCT01367158|O3|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257775|NCT01367158|O2|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
257776|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257777|NCT01367158|O11|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
257778|NCT01367158|O10|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
257779|NCT01367158|O9|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
257780|NCT01367158|O8|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
257781|NCT01367158|O7|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
257782|NCT01367158|O6|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
257783|NCT01367158|O5|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
257784|NCT01367158|O4|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
257785|NCT01367158|O3|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257786|NCT01367158|O2|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
257787|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257788|NCT01367158|O11|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
257789|NCT01367158|O10|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
257790|NCT01367158|O9|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
257791|NCT01367158|O8|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
257792|NCT01367158|O7|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
257793|NCT01367158|O6|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
257794|NCT01367158|O5|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
257795|NCT01367158|O4|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
257796|NCT01367158|O3|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257908|NCT01367119|B1|Baseline|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
269088|NCT01333397|O3|Outcome|Dysport NG 50 U|
257797|NCT01367158|O2|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
257798|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257799|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
257800|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
257801|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
257802|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
257803|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257804|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257805|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
257806|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
257807|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
257808|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
257809|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257810|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257811|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
257812|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
257813|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
257814|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
257815|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257816|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257817|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
257818|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
257819|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
257820|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
257821|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257822|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257823|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
257824|NCT01367158|O5|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
257825|NCT01367158|O4|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
257826|NCT01367158|O3|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
257827|NCT01367158|O2|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
257828|NCT01367158|O1|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
257829|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
257830|NCT01367158|O5|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
257831|NCT01367158|O4|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study.
257832|NCT01367158|O3|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
257833|NCT01367158|O2|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
257834|NCT01367158|O1|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
257835|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
257836|NCT01367158|O5|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
257837|NCT01367158|O4|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
257838|NCT01367158|O3|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
257839|NCT01367158|O2|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
257840|NCT01367158|O1|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
257841|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
257842|NCT01367158|O5|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
257843|NCT01367158|O4|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
257844|NCT01367158|O3|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
257845|NCT01367158|O2|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
257846|NCT01367158|O1|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
257847|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
257848|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
257849|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
257850|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
257851|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
269089|NCT01333397|O2|Outcome|Dysport NG 20 U|
257852|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257853|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
257854|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
257855|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
257856|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
257857|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257858|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257859|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
257860|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
257861|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
257862|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
257863|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257864|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257865|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
257866|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
257867|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
257868|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
257869|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257870|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257871|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
257872|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
257873|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
257874|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
257875|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257876|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257877|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
257878|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
257879|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
257880|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
257881|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257882|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257883|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
257884|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
257885|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
257886|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
257887|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257888|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257889|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
257890|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
257891|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
257892|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
257893|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257894|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257895|NCT01367158|E11|Reported Event|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
257896|NCT01367158|E10|Reported Event|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
257897|NCT01367158|E9|Reported Event|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
257898|NCT01367158|E8|Reported Event|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
257899|NCT01367158|E7|Reported Event|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
257900|NCT01367158|E6|Reported Event|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
257901|NCT01367158|E5|Reported Event|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
257902|NCT01367158|E4|Reported Event|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
257903|NCT01367158|E3|Reported Event|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257904|NCT01367158|E2|Reported Event|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
257905|NCT01367158|E1|Reported Event|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
257906|NCT01367119|B3|Baseline|Total|Total of all reporting groups
257907|NCT01367119|B2|Baseline|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
257909|NCT01367119|P2|Participant Flow|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
257910|NCT01367119|P1|Participant Flow|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
257911|NCT01367119|O2|Outcome|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
257912|NCT01367119|O1|Outcome|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
257913|NCT01367119|O2|Outcome|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
257914|NCT01367119|O1|Outcome|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
257915|NCT01367119|O2|Outcome|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
257916|NCT01367119|O1|Outcome|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
257917|NCT01367119|E2|Reported Event|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
257918|NCT01367119|E1|Reported Event|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
257919|NCT01367080|B3|Baseline|Total|Total of all reporting groups
257920|NCT01367080|B2|Baseline|B Group|Etravil tablet 25mg once daily in first intervention period and Etravil tablet 10mg once daily in second intervention period (10days washout period, Intervention period : 1day)
257921|NCT01367080|B1|Baseline|A Group|Etravil tablet 10mg once daily in first intervention period and Etravil tablet 25mg once daily in second intervention period (10days washout period, Intervention period : 1day)
257922|NCT01367080|P2|Participant Flow|B Group|Etravil tablet 25mg once daily in first intervention period and Etravil tablet 10mg once daily in second intervention period (10days washout period, Intervention period : 1day)
257923|NCT01367080|P1|Participant Flow|A Group|Etravil tablet 10mg once daily in first intervention period and Etravil tablet 25mg once daily in second intervention period (10days washout period, Intervention period : 1day)
257924|NCT01367080|O2|Outcome|Etravil 25mg Group|Amitryptiline Hydrochloride 25mg Administration Group
257925|NCT01367080|O1|Outcome|Etravil 10mg Group|Amitryptiline Hydrochloride 10mg Administration Group
257926|NCT01367080|O2|Outcome|Etravil 25mg Group|Amitryptiline Hydrochloride 25mg Administration Group
257927|NCT01367080|O1|Outcome|Etravil 10mg Group|Amitryptiline Hydrochloride 10mg Administration Group
257928|NCT01367080|O2|Outcome|Etravil 25mg Group|Amitryptiline Hydrochloride 25mg Administration Group
257929|NCT01367080|O1|Outcome|Etravil 10mg Group|Amitryptiline Hydrochloride 10mg Administration Group
257930|NCT01367080|O2|Outcome|Etravil 25mg Group|Amitryptiline hydrochloride 25mg administration Group
257931|NCT01367080|O1|Outcome|Etravil 10mg Group|Amitryptiline Hydrochloride 10mg administration Group
257932|NCT01367080|E2|Reported Event|Etravil 25mg Group|Amitryptyline hydrochloride 25mg administration Group
257933|NCT01367080|E1|Reported Event|Etravil 10mg Group|Amitryptyline hydrochloride 10mg administration Group
257934|NCT01366976|B3|Baseline|Total|Total of all reporting groups
257935|NCT01366976|B2|Baseline|Placebo|Saline in equivalent volume as study drug
257936|NCT01366976|B1|Baseline|Acetaminophen|IV acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
257937|NCT01366976|P2|Participant Flow|Placebo|Saline in equivalent volume as study drug
257938|NCT01366976|P1|Participant Flow|Acetaminophen|IV acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
257939|NCT01366976|O2|Outcome|Placebo|Saline infusion
257940|NCT01366976|O1|Outcome|Acetaminophen|IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
257941|NCT01366976|O2|Outcome|Placebo|Saline infusion
257942|NCT01366976|O1|Outcome|Acetaminophen|IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
257943|NCT01366976|O2|Outcome|Placebo|Saline infusion
257944|NCT01366976|O1|Outcome|Acetaminophen|IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
257945|NCT01366976|O2|Outcome|Placebo|Saline infusion
257946|NCT01366976|O1|Outcome|Acetaminophen|IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
257947|NCT01366976|E2|Reported Event|Placebo|Saline infusion
257948|NCT01366976|E1|Reported Event|Acetaminophen|IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
257949|NCT01366885|B1|Baseline|Intervention During Pregnancy|"5000 IU Vitamin D3 to be given to the mother during pregnancy. 7000 IU Vitamin D3 to be given during breast feeding if breast feeding. If not breastfeeding, infant to be given 400 IU Vitamin D3 during first year of age, then increased to 1000 IU D3 until completion of research trial.~Vitamin D3: 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age."
257950|NCT01366885|P1|Participant Flow|Intervention During Pregnancy|"5000 IU Vitamin D3 to be given to the mother during pregnancy. 7000 IU Vitamin D3 to be given during breast feeding if breast feeding. If not breastfeeding, infant to be given 400 IU Vitamin D3 during first year of age, then increased to 1000 IU D3 until completion of research trial.~Vitamin D3: 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age."
257951|NCT01366885|O1|Outcome|Intervention During Pregnancy|"5000 IU Vitamin D3 to be given to the mother during pregnancy. 7000 IU Vitamin D3 to be given during breast feeding if breast feeding. If not breastfeeding, infant to be given 400 IU Vitamin D3 during first year of age, then increased to 1000 IU D3 until completion of research trial.~Vitamin D3: 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age."
258194|NCT01366196|O1|Outcome|Control Group (C)|Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.
257952|NCT01366885|O1|Outcome|Intervention During Pregnancy|"5000 IU Vitamin D3 to be given to the mother during pregnancy. 7000 IU Vitamin D3 to be given during breast feeding if breast feeding. If not breastfeeding, infant to be given 400 IU Vitamin D3 during first year of age, then increased to 1000 IU D3 until completion of research trial.~Vitamin D3: 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age."
257953|NCT01366885|E1|Reported Event|Intervention During Pregnancy|"5000 IU Vitamin D3 to be given to the mother during pregnancy. 7000 IU Vitamin D3 to be given during breast feeding if breast feeding. If not breastfeeding, infant to be given 400 IU Vitamin D3 during first year of age, then increased to 1000 IU D3 until completion of research trial.~Vitamin D3: 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age."
257954|NCT01366872|B1|Baseline|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
257955|NCT01366872|P1|Participant Flow|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
257956|NCT01366872|O1|Outcome|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
257957|NCT01366872|O1|Outcome|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
257958|NCT01366872|O1|Outcome|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
257959|NCT01366872|E1|Reported Event|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
257960|NCT01366846|B5|Baseline|Total|Total of all reporting groups
257961|NCT01366846|B4|Baseline|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
257962|NCT01366846|B3|Baseline|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
257963|NCT01366846|B2|Baseline|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
257964|NCT01366846|B1|Baseline|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
257965|NCT01366846|P4|Participant Flow|Positive Stratum – Peanut Avoidance After Peanut Consumption G|Participants who had a positive response to a peanut allergen skin prick test (a wheal measuring between 1 and 4 mm) and were then randomized into the peanut consumption group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial).
257966|NCT01366846|P3|Participant Flow|Positive Stratum – Continued Peanut Avoidance Group|Participants who had a positive response to a peanut allergen skin prick test (a wheal measuring between 1 and 4 mm) and were then randomized into the peanut avoidance group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial).
257967|NCT01366846|P2|Participant Flow|Negative Stratum – Peanut Avoidance After Consumption Group|Participants who had a negative response to a peanut allergen skin prick test (no measurable wheal) and were then randomized into the peanut consumption group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial).
257968|NCT01366846|P1|Participant Flow|Negative Stratum – Continued Peanut Avoidance Group|Participants who had a negative response to a peanut allergen skin prick test (no measurable wheal) and were then randomized into the peanut avoidance group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial)
257969|NCT01366846|O1|Outcome|Peanut Avoidance After Peanut Consumption Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut consumption group were asked to consume at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. Upon transitioning from LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784) to LEAP-On (this trial), participants were instructed to avoid peanut protein during study participation.
257970|NCT01366846|O1|Outcome|Peanut Avoidance After Peanut Consumption Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut consumption group were asked to consume at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. Upon transitioning from LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784) to LEAP-On (this trial), participants were instructed to avoid peanut protein during study participation.
258240|NCT01365650|O2|Outcome|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
257971|NCT01366846|O2|Outcome|Peanut Avoidance After Peanut Consumption Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut consumption group were asked to consume at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. Upon transitioning from LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784) to LEAP-On (this trial), participants were instructed to avoid peanut protein during study participation.
257972|NCT01366846|O1|Outcome|Continued Peanut Avoidance Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation. This group continued to avoid peanut protein throughout LEAP-On (this trial).
257973|NCT01366846|O4|Outcome|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
257974|NCT01366846|O3|Outcome|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
257975|NCT01366846|O2|Outcome|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
257976|NCT01366846|O1|Outcome|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
257977|NCT01366846|O2|Outcome|Peanut Avoidance After Peanut Consumption Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut consumption group were asked to consume at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. Upon transitioning from LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784) to LEAP-On (this trial), participants were instructed to avoid peanut protein during study participation.
257978|NCT01366846|O1|Outcome|Continued Peanut Avoidance Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation. This group continued to avoid peanut protein throughout LEAP-On (this trial).
257979|NCT01366846|O4|Outcome|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
257980|NCT01366846|O3|Outcome|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
257981|NCT01366846|O2|Outcome|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
257982|NCT01366846|O1|Outcome|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
257983|NCT01366846|E4|Reported Event|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
257984|NCT01366846|E3|Reported Event|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
257985|NCT01366846|E2|Reported Event|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
257986|NCT01366846|E1|Reported Event|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
257987|NCT01366638|B4|Baseline|Total|Total of all reporting groups
257988|NCT01366638|B3|Baseline|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
258241|NCT01365650|O1|Outcome|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
257989|NCT01366638|B2|Baseline|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
257990|NCT01366638|B1|Baseline|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
257991|NCT01366638|P3|Participant Flow|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
257992|NCT01366638|P2|Participant Flow|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
257993|NCT01366638|P1|Participant Flow|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
257994|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
257995|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
257996|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
257997|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
257998|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
257999|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
258000|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
258001|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
258002|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
258003|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
258004|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
258005|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
258006|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
258007|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
258008|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
258009|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
258010|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
258011|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
258012|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
258013|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
258014|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
258015|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
258016|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
258017|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
258018|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
258019|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
258020|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
258021|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
258022|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
258023|NCT01366638|E3|Reported Event|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
258024|NCT01366638|E2|Reported Event|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
258272|NCT01365624|O1|Outcome|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
269090|NCT01333397|O1|Outcome|Placebo|
258025|NCT01366638|E1|Reported Event|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
258026|NCT01366534|B4|Baseline|Total|Total of all reporting groups
258027|NCT01366534|B3|Baseline|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
258028|NCT01366534|B2|Baseline|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258029|NCT01366534|B1|Baseline|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258030|NCT01366534|P3|Participant Flow|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
258031|NCT01366534|P2|Participant Flow|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258032|NCT01366534|P1|Participant Flow|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258033|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258034|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258035|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
258036|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258037|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258038|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
258039|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258040|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258041|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
258042|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258043|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258044|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
258045|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258046|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258047|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
258048|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258049|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258050|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
258051|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258052|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258053|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
258054|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258055|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258056|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
258057|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258058|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258059|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
258060|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258061|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258062|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
258063|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258064|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258065|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258066|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258067|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258068|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258069|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258273|NCT01365624|O2|Outcome|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
258070|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258071|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
258072|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258073|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258074|NCT01366534|E3|Reported Event|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
258075|NCT01366534|E2|Reported Event|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258076|NCT01366534|E1|Reported Event|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
258077|NCT01366521|B5|Baseline|Total|Total of all reporting groups
258078|NCT01366521|B4|Baseline|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258079|NCT01366521|B3|Baseline|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258080|NCT01366521|B2|Baseline|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258081|NCT01366521|B1|Baseline|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258082|NCT01366521|P4|Participant Flow|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258083|NCT01366521|P3|Participant Flow|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258084|NCT01366521|P2|Participant Flow|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258085|NCT01366521|P1|Participant Flow|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258086|NCT01366521|O4|Outcome|Mepolizumab SC Overall|Combined results for participants receiving either mepolizumab 12.5 mg, 125 mg or 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258087|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258088|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258089|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258090|NCT01366521|O4|Outcome|Mepolizumab SC Overall|Combined results for participants receiving either mepolizumab 12.5 mg, 125 mg or 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258091|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258274|NCT01365624|O1|Outcome|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
275135|NCT01315158|B3|Baseline|Total|Total of all reporting groups
258092|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258093|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258094|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258095|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258096|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258097|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258098|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258099|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258100|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258101|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258102|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258103|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258104|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258105|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258106|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258107|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258108|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258109|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258110|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258111|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258112|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258113|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258275|NCT01365624|O2|Outcome|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
258114|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258115|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258116|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258117|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258118|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258119|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258120|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258121|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258122|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258123|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258124|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258125|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258126|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258127|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258128|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258129|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258130|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258131|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258132|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258133|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258134|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258135|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258276|NCT01365624|O1|Outcome|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
258136|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258137|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258138|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258139|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258140|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258141|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258142|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258143|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258144|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258145|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258146|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258147|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258148|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258149|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258150|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258151|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258152|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258153|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258154|NCT01366521|E5|Reported Event|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258155|NCT01366521|E4|Reported Event|Mepolizumab SC Overall|Combined results for participants receiving either mepolizumab 12.5 mg, 125 mg or 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258156|NCT01366521|E3|Reported Event|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258157|NCT01366521|E2|Reported Event|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258829|NCT01363661|B1|Baseline|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
258158|NCT01366521|E1|Reported Event|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
258159|NCT01366443|B1|Baseline|Women Pregnant|Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.
258160|NCT01366443|P1|Participant Flow|Women Pregnant|Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.
258161|NCT01366443|O2|Outcome|Pregnant Women (ROM Plus vs. Chart Review)|This study was a multi-center prospective observational study performed in patients presenting with signs or symptoms of rupture of amniotic membranes. Initial evaluation included the new combination immunoassay ROM Plus containing a combination of monoclonal and polyclonal antibodies to Placental Protein 12 (PP12) and Alpha-fetoprotein (AFP). The clinical diagnosis of rupture of membranes was confirmed on review of the medical chart records following delivery.
258162|NCT01366443|O1|Outcome|Pregnant Women (Clinical Assessment vs. Chart Review)|This study was a multi-center prospective observational study performed in patients presenting with signs or symptoms of rupture of amniotic membranes. Initial evaluation included the standard clinical assessment for rupture of membranes. The clinical diagnosis of rupture of membranes was confirmed on review of the medical chart records following delivery.
258163|NCT01366443|E1|Reported Event|Women Pregnant|Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.
258164|NCT01366417|B1|Baseline|ChloraPrep One Step and 70% Isopropyl Alcohol|All subjects received a single topical treatment with both the test article (ChloraPrep One Step) and the positive control (Isopropyl Alcohol)
258165|NCT01366417|P1|Participant Flow|ChloraPrep One Step and 70% Isopropyl Alcohol|All subjects received a single topical treatment with both the test article (ChloraPrep One Step) and the positive control (Isopropyl Alcohol)
258166|NCT01366417|O2|Outcome|70% Isopropyl Alcohol|All subjects received a single topical application of 70% Isopropyl Alcohol.
258167|NCT01366417|O1|Outcome|ChloraPrep One Step|All subjects received a single topical application of ChloraPrep One Step.
258168|NCT01366417|O2|Outcome|70% Isopropyl Alcohol|All subjects received a single topical application of 70% Isopropyl Alcohol.
258169|NCT01366417|O1|Outcome|ChloraPrep One Step|All subjects received a single topical application of ChloraPrep One Step.
258170|NCT01366417|E1|Reported Event|ChloraPrep One Step and 70% Isopropyl Alcohol|All subjects received a single topical treatment with both the test article (ChloraPrep One Step) and the positive control (Isopropyl Alcohol)
258171|NCT01366209|B3|Baseline|Total|Total of all reporting groups
258172|NCT01366209|B2|Baseline|Placebo Arm|Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
258173|NCT01366209|B1|Baseline|Active Arm|Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
258174|NCT01366209|P2|Participant Flow|Placebo Arm|Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
258175|NCT01366209|P1|Participant Flow|Active Arm|Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
258176|NCT01366209|O2|Outcome|Placebo Arm|Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
258177|NCT01366209|O1|Outcome|Active Arm|Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
258178|NCT01366209|E2|Reported Event|Placebo Arm|Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
258179|NCT01366209|E1|Reported Event|Active Arm|Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
258180|NCT01366196|B3|Baseline|Total|Total of all reporting groups
258181|NCT01366196|B2|Baseline|Pregabalin Group (P)|Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.
258182|NCT01366196|B1|Baseline|Control Group (C)|Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.
258183|NCT01366196|P2|Participant Flow|Pregabalin Group (P)|Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.
258184|NCT01366196|P1|Participant Flow|Control Group (C)|Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.
258185|NCT01366196|O2|Outcome|Pregabalin Group (P)|Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.
258186|NCT01366196|O1|Outcome|Control Group (C)|Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.
258187|NCT01366196|O2|Outcome|Pregabalin Group (P)|Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.
258188|NCT01366196|O1|Outcome|Control Group (C)|Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.
258189|NCT01366196|O2|Outcome|Pregabalin Group (P)|Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.
258190|NCT01366196|O1|Outcome|Control Group (C)|Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.
258191|NCT01366196|O2|Outcome|Pregabalin Group (P)|Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.
258192|NCT01366196|O1|Outcome|Control Group (C)|Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.
258193|NCT01366196|O2|Outcome|Pregabalin Group (P)|Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.
258195|NCT01366196|E2|Reported Event|Pregabalin Group (P)|"Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.~Postoperative pain will be assessed daily until discharge using a verbal Numerical Rating Scale (NRS) at rest and during physical therapy, by both physical therapists and blinded research assistants.~All narcotics (i.v. PCA, oral or IM/SQ rescue doses) will be tabulated during their hospital stay, and patients will be asked to document their oral narcotic use after discharge.~On the day of discharge, patients will be given a self report data sheet, in which they will be asked to record their daily pain level at rest, with movement, and whether their pain interfered with sleep.~Pregabalin 150 mg: Patients will receive two 75 mg capsules of pregabalin 1 hour before surgery. They continue to take 2 capsules of 75 mg (total 150 mg) until POD 14."
258196|NCT01366196|E1|Reported Event|Control Group (C)|"Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.~Postoperative pain will be assessed daily until discharge using a verbal Numerical Rating Scale (NRS) at rest and during physical therapy, by both physical therapists and blinded research assistants.~All narcotics (i.v. PCA, oral or IM/SQ rescue doses) will be tabulated during their hospital stay, and patients will be asked to document their oral narcotic use after discharge.~On the day of discharge, patients will be given a self report data sheet, in which they will be asked to record their daily pain level at rest, with movement, and whether their pain interfered with sleep.~Placebo: Patients will first receive two capsules of the placebo drug (with no active ingredients per dose) one hour before surgery. Patients will continue taking two capsules per day until POD 14."
258197|NCT01366092|B1|Baseline|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
258198|NCT01366092|P1|Participant Flow|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
258199|NCT01366092|O1|Outcome|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
258200|NCT01366092|O1|Outcome|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
258201|NCT01366092|O1|Outcome|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
258202|NCT01366092|O1|Outcome|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
258203|NCT01366092|O1|Outcome|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
258204|NCT01366092|O1|Outcome|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
258205|NCT01366092|E1|Reported Event|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
258206|NCT01365910|B1|Baseline|Treatment (Enzyme Inhibitor)|Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
258207|NCT01365910|P1|Participant Flow|Treatment (Enzyme Inhibitor)|ABT-869/Linifanib will be administered orally on a daily basis at 17.5 mg/day (fixed dose). The drug is provided in tablets of 2.5 mg or 10 mg tablets.This course of treatment repeats every 28 days until disease progression, intolerability, investigator decision or patient withdrawal of consent.
258208|NCT01365910|O1|Outcome|Treatment (Enzyme Inhibitor)|"Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~linifanib: Given PO"
258209|NCT01365910|O1|Outcome|Treatment (Enzyme Inhibitor)|"Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~linifanib: Given PO"
258210|NCT01365910|O1|Outcome|Treatment (Enzyme Inhibitor)|"Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~linifanib: Given PO"
258211|NCT01365910|O1|Outcome|Treatment (Enzyme Inhibitor)|"Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~linifanib: Given PO"
258212|NCT01365910|E1|Reported Event|Treatment (Enzyme Inhibitor)|"Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~linifanib: Given PO"
258213|NCT01365845|B1|Baseline|Breast Patients Planned With Both Proton & Conventional Plans|"Each patient is planned with both proton and conventional plans and the superior plan is chosen for treatment.~Conventional plan: 50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction~Proton plan: 50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction"
258214|NCT01365845|P3|Participant Flow|3D-Proton/Conventional Plan or 3D-proton Only|"3D-Proton/Conventional plan or 3D-proton only: 50.4 Cobalt Gray Equivalent (CGE)/Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 CGE/Gy~This number will automatically be equal to 0 during the 'induction phase' period and will only have a count in the 'treatment phase' period if a patient was actually assigned to this treatment."
258215|NCT01365845|P2|Participant Flow|Conventional Photon Plan|"Conventional (photon): 50.4 Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction~This number will automatically be equal to 0 during the 'induction phase' period and will only have a count in the 'treatment phase' period if a patient was actually assigned to this treatment."
258216|NCT01365845|P1|Participant Flow|Induction Phase|During this phase, each patient will have both a proton and conventional radiation plan performed. The superior plan in regard to minimizing dose to heart will be the plan actually chosen for treating the patient.
258217|NCT01365845|O2|Outcome|3D-Proton/Conventional Plan or 3D-proton Only|3D-Proton/Conventional plan or 3D-proton only: 50.4 Cobalt Gray Equivalent (CGE)/Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 CGE/Gy per fraction
258218|NCT01365845|O1|Outcome|Conventional Photon Plan|Photon: 50.4 Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction
258239|NCT01365650|O3|Outcome|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
258219|NCT01365845|E1|Reported Event|Breast Patients Planned With Both Proton & Conventional Plans|"All patients ultimately treated under the proton plan, so the denominator for all adverse events refers exclusively to the proton arm and not conventional.~Each patient was planned with both proton and conventional plans and the superior plan was chosen for treatment.~Conventional plan: 50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction~Proton plan: 50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction"
258220|NCT01365819|B3|Baseline|Total|Total of all reporting groups
258221|NCT01365819|B2|Baseline|Varenicline|"Varenicline (Chantix (R))~Varenicline: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
258222|NCT01365819|B1|Baseline|Sugar Pill|"Placebo~Placebo: Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
258223|NCT01365819|P2|Participant Flow|Varenicline|"Varenicline (Chantix (R))~Varenicline: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
258224|NCT01365819|P1|Participant Flow|Sugar Pill|"Placebo~Placebo: Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
258225|NCT01365819|O2|Outcome|Varenicline|"Varenicline (Chantix (R))~Varenicline: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
258226|NCT01365819|O1|Outcome|Sugar Pill|"Placebo~Placebo: Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
258227|NCT01365819|O2|Outcome|Varenicline|"Varenicline (Chantix (R))~Varenicline: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
258228|NCT01365819|O1|Outcome|Sugar Pill|"Placebo~Placebo: Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
258229|NCT01365819|O2|Outcome|Varenicline|"Varenicline (Chantix (R))~Varenicline: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
258230|NCT01365819|O1|Outcome|Sugar Pill|"Placebo~Placebo: Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
258231|NCT01365819|O2|Outcome|Varenicline|"Varenicline (Chantix (R))~Varenicline: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
258232|NCT01365819|O1|Outcome|Sugar Pill|"Placebo~Placebo: Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
258233|NCT01365819|O2|Outcome|Varenicline|"Varenicline (Chantix (R))~Varenicline: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
258234|NCT01365819|O1|Outcome|Sugar Pill|"Placebo~Placebo: Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
258235|NCT01365819|E2|Reported Event|Varenicline|"Varenicline (Chantix (R))~Varenicline: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
258236|NCT01365819|E1|Reported Event|Sugar Pill|"Placebo~Placebo: Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
258237|NCT01365650|B1|Baseline|All Study Participants|Treatment A: Single intranasal (i.n.) dose of Ketorolac tromethamine (KT) 30 mg (one 15 mg spray into each nostril) on day 1 of Period 1 followed by a 2-7 day washout interval Treatment B: Single i.n. dose of oxymetazoline hydrochloride (OH) followed 30 minutes later by a single i.n. dose of KT 30 mg (one 15 mg spray into each nostril) of Period 2 followed by a 2-7 day washout interval Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of KT 30 mg (one 15 mg spray into each nostril) on day 1 of Period 3
258238|NCT01365650|P1|Participant Flow|Symptomatic Allergic Rhinitis|Treatment A: Single intranasal (i.n.) dose of Ketorolac tromethamine (KT) 30 mg (one 15 mg spray into each nostril) on day 1 of Period 1 followed by a 2-7 day washout interval Treatment B: Single i.n. dose of oxymetazoline hydrochloride (OH) followed 30 minutes later by a single i.n. dose of KT 30 mg (one 15 mg spray into each nostril) of Period 2 followed by a 2-7 day washout interval Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of KT 30 mg (one 15 mg spray into each nostril) on day 1 of Period 3
258277|NCT01365624|E2|Reported Event|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
258242|NCT01365650|O3|Outcome|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
258243|NCT01365650|O2|Outcome|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
258244|NCT01365650|O1|Outcome|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
258245|NCT01365650|O3|Outcome|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
258246|NCT01365650|O2|Outcome|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
258247|NCT01365650|O1|Outcome|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
258248|NCT01365650|O3|Outcome|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
258249|NCT01365650|O2|Outcome|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
258250|NCT01365650|O1|Outcome|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
258251|NCT01365650|O3|Outcome|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
258252|NCT01365650|O2|Outcome|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
258253|NCT01365650|O1|Outcome|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
258254|NCT01365650|O3|Outcome|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
258255|NCT01365650|O2|Outcome|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
258256|NCT01365650|O1|Outcome|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
258257|NCT01365650|E3|Reported Event|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
258258|NCT01365650|E2|Reported Event|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
258259|NCT01365650|E1|Reported Event|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
258260|NCT01365624|B3|Baseline|Total|Total of all reporting groups
258261|NCT01365624|B2|Baseline|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
258262|NCT01365624|B1|Baseline|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
258263|NCT01365624|P2|Participant Flow|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
258264|NCT01365624|P1|Participant Flow|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
258265|NCT01365624|O2|Outcome|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
258266|NCT01365624|O1|Outcome|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
258267|NCT01365624|O2|Outcome|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
258268|NCT01365624|O1|Outcome|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
258269|NCT01365624|O2|Outcome|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
258270|NCT01365624|O1|Outcome|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
258271|NCT01365624|O2|Outcome|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
261081|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
258278|NCT01365624|E1|Reported Event|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
258279|NCT01365611|B1|Baseline|All Study Participants|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6. Subjects received a single daily intranasal dose of 200mg fluticasone propionate on Days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
258280|NCT01365611|P1|Participant Flow|All Study Participants|"A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.~Subjects received a single daily intranasal dose of 200mg fluticasone propionate on Days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6."
258281|NCT01365611|O2|Outcome|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
258282|NCT01365611|O1|Outcome|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
258283|NCT01365611|O2|Outcome|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
258284|NCT01365611|O1|Outcome|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
258285|NCT01365611|O2|Outcome|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
258286|NCT01365611|O1|Outcome|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
258287|NCT01365611|O2|Outcome|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
258288|NCT01365611|O1|Outcome|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
258289|NCT01365611|O2|Outcome|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
258290|NCT01365611|O1|Outcome|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
258291|NCT01365611|O2|Outcome|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
258292|NCT01365611|O1|Outcome|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
258293|NCT01365611|E2|Reported Event|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
258294|NCT01365611|E1|Reported Event|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
258295|NCT01365585|B1|Baseline|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
258296|NCT01365585|P1|Participant Flow|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
258297|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
258298|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
258299|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
258300|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
258301|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
258302|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
258303|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
277028|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
258304|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
258305|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
258306|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
258307|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
258308|NCT01365585|E1|Reported Event|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
258309|NCT01365546|B1|Baseline|Human VWF/FVIII Concentrate|human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery
258310|NCT01365546|P1|Participant Flow|Human VWF/FVIII Concentrate|human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery
258311|NCT01365546|O1|Outcome|Post-operative Assessment by IDMC|
258312|NCT01365546|O1|Outcome|Intra-operative Assessment by IDMC|
258313|NCT01365546|O3|Outcome|All Surgeries|
258314|NCT01365546|O2|Outcome|Major Surgery|
258315|NCT01365546|O1|Outcome|Minor Surgery|human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery
258316|NCT01365546|E1|Reported Event|Human VWF/FVIII Concentrate|human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery
258317|NCT01365507|B3|Baseline|Total|Total of all reporting groups
258318|NCT01365507|B2|Baseline|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
258319|NCT01365507|B1|Baseline|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
258320|NCT01365507|P2|Participant Flow|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
258321|NCT01365507|P1|Participant Flow|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
258322|NCT01365507|O2|Outcome|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
258323|NCT01365507|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
258324|NCT01365507|O2|Outcome|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
258325|NCT01365507|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
258326|NCT01365507|O2|Outcome|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
258327|NCT01365507|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
258328|NCT01365507|O2|Outcome|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
258830|NCT01363661|P2|Participant Flow|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
279174|NCT01303224|O2|Outcome|Ibodutant 3 mg|oral tablet, once daily
258329|NCT01365507|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
258330|NCT01365507|O2|Outcome|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
258331|NCT01365507|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
258332|NCT01365507|E2|Reported Event|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
258333|NCT01365507|E1|Reported Event|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
258334|NCT01365494|B3|Baseline|Total|Total of all reporting groups
258335|NCT01365494|B2|Baseline|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedules."
258336|NCT01365494|B1|Baseline|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedules."
258337|NCT01365494|P2|Participant Flow|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
258338|NCT01365494|P1|Participant Flow|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to either Zagreb schedule."
258339|NCT01365494|O2|Outcome|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
258340|NCT01365494|O1|Outcome|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule."
258341|NCT01365494|O2|Outcome|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
258342|NCT01365494|O1|Outcome|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb schedule) (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule."
258343|NCT01365494|O2|Outcome|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
258344|NCT01365494|O1|Outcome|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule."
258345|NCT01365494|O2|Outcome|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
258346|NCT01365494|O1|Outcome|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule."
258347|NCT01365494|E2|Reported Event|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
258348|NCT01365494|E1|Reported Event|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule."
258349|NCT01365481|B5|Baseline|Total|Total of all reporting groups
258350|NCT01365481|B4|Baseline|Non-CKD Patients: Valsartan Alone|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
258351|NCT01365481|B3|Baseline|Non-CKD Patients: Valsartan + Antihypertensive Group|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
258352|NCT01365481|B2|Baseline|CKD Patients: Valsartan Alone|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
258353|NCT01365481|B1|Baseline|CKD Patients: Valsartan + Antihypertensive Group|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
258354|NCT01365481|P4|Participant Flow|Non-CKD Patients: Valsartan Alone|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
258355|NCT01365481|P3|Participant Flow|Non-CKD Patients: Valsartan + Antihypertensive Group|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
258356|NCT01365481|P2|Participant Flow|CKD Patients: Valsartan Alone|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
258357|NCT01365481|P1|Participant Flow|CKD Patients: Valsartan + Antihypertensive Group|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
258358|NCT01365481|O2|Outcome|Valsartan Alone|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
258359|NCT01365481|O1|Outcome|Valsartan + Antihypertensive Group|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
258360|NCT01365481|O2|Outcome|Valsartan Alone|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
258361|NCT01365481|O1|Outcome|Valsartan + Antihypertensive Group|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
258362|NCT01365481|O2|Outcome|Valsartan Alone|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
258363|NCT01365481|O1|Outcome|Valsartan + Antihypertensive Group|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
258831|NCT01363661|P1|Participant Flow|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
258364|NCT01365481|O2|Outcome|Valsartan Alone|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
258365|NCT01365481|O1|Outcome|Valsartan + Antihypertensive Group|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
258366|NCT01365481|O2|Outcome|Valsartan Alone|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
258367|NCT01365481|O1|Outcome|Valsartan + Antihypertensive Group|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
258368|NCT01365481|E6|Reported Event|Non-CKD Patients: Valsartan Alone|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
258369|NCT01365481|E5|Reported Event|Non-CKD Patients: Valsartan + Antihypertensive Group|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
258370|NCT01365481|E4|Reported Event|CKD Patients: Valsartan Alone|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
258371|NCT01365481|E3|Reported Event|CKD Patients: Valsartan + Antihypertensive Group|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
258372|NCT01365481|E2|Reported Event|Valsartan Alone|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
258373|NCT01365481|E1|Reported Event|Valsartan + Antihypertensive Group|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
258374|NCT01365468|B3|Baseline|Total|Total of all reporting groups
258375|NCT01365468|B2|Baseline|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
258376|NCT01365468|B1|Baseline|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
258377|NCT01365468|P2|Participant Flow|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
258378|NCT01365468|P1|Participant Flow|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
261082|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
258379|NCT01365468|O2|Outcome|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
258380|NCT01365468|O1|Outcome|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
258381|NCT01365468|O2|Outcome|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
258382|NCT01365468|O1|Outcome|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
258383|NCT01365468|O2|Outcome|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
258384|NCT01365468|O1|Outcome|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
258385|NCT01365468|O1|Outcome|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
258386|NCT01365468|O1|Outcome|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
258387|NCT01365468|E2|Reported Event|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
258388|NCT01365468|E1|Reported Event|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
258389|NCT01365455|B4|Baseline|Total|Total of all reporting groups
258390|NCT01365455|B3|Baseline|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258391|NCT01365455|B2|Baseline|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258392|NCT01365455|B1|Baseline|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258393|NCT01365455|P5|Participant Flow|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258394|NCT01365455|P4|Participant Flow|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258395|NCT01365455|P3|Participant Flow|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258619|NCT01364649|B1|Baseline|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
258396|NCT01365455|P2|Participant Flow|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258397|NCT01365455|P1|Participant Flow|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258398|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258399|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258400|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258401|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258402|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258403|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258404|NCT01365455|O5|Outcome|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258405|NCT01365455|O4|Outcome|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258406|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258407|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258408|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258409|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258410|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258411|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258412|NCT01365455|O5|Outcome|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258413|NCT01365455|O4|Outcome|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258414|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258832|NCT01363661|O2|Outcome|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
258415|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258416|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258417|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258418|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258419|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258420|NCT01365455|O5|Outcome|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258421|NCT01365455|O4|Outcome|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258422|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258423|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258424|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258425|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258426|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258427|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258428|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258429|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258430|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258431|NCT01365455|O5|Outcome|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258432|NCT01365455|O4|Outcome|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258433|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
259514|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
258434|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258435|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258436|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258437|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258438|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258439|NCT01365455|O5|Outcome|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258440|NCT01365455|O4|Outcome|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258441|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258442|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258443|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258444|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258445|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258446|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258447|NCT01365455|O5|Outcome|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258448|NCT01365455|O4|Outcome|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258449|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258450|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258451|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258452|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
259515|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
258453|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258454|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258455|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258456|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258457|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258458|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258459|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258460|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258461|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258462|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258463|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258464|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258465|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258466|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258467|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258468|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258469|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258470|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
258833|NCT01363661|O1|Outcome|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
258471|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258472|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
258473|NCT01365455|E11|Reported Event|FOLLOW UP-Placebo|FOLLOW UP-Placebo
258474|NCT01365455|E10|Reported Event|FOLLOW UP-Any AIN457 300mg|FOLLOW UP-Any AIN457 300mg
258475|NCT01365455|E9|Reported Event|FOLLOW UP-Any AIN457 150mg|FOLLOW UP-Any AIN457 150mg
258476|NCT01365455|E8|Reported Event|ENTIRE-Placebo|ENTIRE-Placebo
258477|NCT01365455|E7|Reported Event|ENTIRE-Any AIN457 300mg|ENTIRE-Any AIN457 300mg
258478|NCT01365455|E6|Reported Event|ENTIRE-Any AIN457 150mg|ENTIRE-Any AIN457 150mg
258479|NCT01365455|E5|Reported Event|ENTIRE-AIN457 300mg|ENTIRE-AIN457 300mg
258480|NCT01365455|E4|Reported Event|ENTIRE-AIN457 150mg|ENTIRE-AIN457 150mg
258481|NCT01365455|E3|Reported Event|INDUCTION-Placebo|INDUCTION-Placebo
258482|NCT01365455|E2|Reported Event|INDUCTION-AIN457 300mg|INDUCTION-AIN457 300mg
258483|NCT01365455|E1|Reported Event|INDUCTION-AIN457 150mg|INDUCTION-AIN457 150mg
258484|NCT01365273|B3|Baseline|Total|Total of all reporting groups
258485|NCT01365273|B2|Baseline|Mepitel One|Device
258486|NCT01365273|B1|Baseline|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
258487|NCT01365273|P2|Participant Flow|Mepitel One|Device
258488|NCT01365273|P1|Participant Flow|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
258489|NCT01365273|O2|Outcome|Mepitel One|Device
258490|NCT01365273|O1|Outcome|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
258491|NCT01365273|O2|Outcome|Mepitel One|Device
258492|NCT01365273|O1|Outcome|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
258493|NCT01365273|O2|Outcome|Mepitel One|Device
258494|NCT01365273|O1|Outcome|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
258495|NCT01365273|E2|Reported Event|Mepitel One|Device
258496|NCT01365273|E1|Reported Event|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
258497|NCT01365130|B1|Baseline|Real Drug|"patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity~jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression"
258498|NCT01365130|P1|Participant Flow|Real Drug|"patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity~jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression"
258499|NCT01365130|O1|Outcome|Real Drug|"patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity~jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression"
258500|NCT01365130|O1|Outcome|Real Drug|"patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity~jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression"
258501|NCT01365130|E1|Reported Event|Real Drug|"patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity~jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression"
258502|NCT01365091|B5|Baseline|Total|Total of all reporting groups
258503|NCT01365091|B4|Baseline|Arm 4: Treatments G/ H, H/G|"Period 1: Participants received a single oral dose of saxagliptin , 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fed state (Treatment G)."
258504|NCT01365091|B3|Baseline|Arm 3:Treatments E/ F, F/E|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5- mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fasted state (Treatment E)."
258505|NCT01365091|B2|Baseline|Arm 2: Treatments C/D, D/C|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metforminXR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fed state (Treatment C)."
258506|NCT01365091|B1|Baseline|Arm 1: Treatments A/B, B/A|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg, tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fasted state (Treatment A)."
258834|NCT01363661|O2|Outcome|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
258507|NCT01365091|P4|Participant Flow|Arm 4: Treatments G/ H, H/G|"Period 1: Participants received a single oral dose of saxagliptin , 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fed state (Treatment G)."
258508|NCT01365091|P3|Participant Flow|Arm 3:Treatments E/ F, F/E|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5- mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fasted state (Treatment E)."
258509|NCT01365091|P2|Participant Flow|Arm 2: Treatments C/D, D/C|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metforminXR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fed state (Treatment C)."
258510|NCT01365091|P1|Participant Flow|Arm 1: Treatments A/B, B/A|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg, tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fasted state (Treatment A)."
258511|NCT01365091|O4|Outcome|Sax, 5 mg/Met 1000 mg XR FDC to Individual Tablets, Fed|"Arm 4: Treatments G,H/H,G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fed state (Treatment G)."
258512|NCT01365091|O3|Outcome|Sax, 5 mg/Met 1000 mg XR FDC to Individual Tablets, Fasted|"Arm 3: Treatment E, F/F, G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 1000-mg tablets, together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fasted state (Treatment E)."
258513|NCT01365091|O2|Outcome|Sax, 5 mg/Met 500 mg XR FDC to Individual Tablets, Fed|"Arm 2: Treatment C, D/D, C. Period 1: Participants received a single oral dose of saxagliptin (sax) 5-mg/metformin (met) 500-mg, extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 500-mg XR FDC, in the fed state (Treatment C)."
258514|NCT01365091|O1|Outcome|Sax, 5 mg/Met 500 mg XR FDC to Individual Tablets, Fasted|"Arm 1: Treatments A, B/B, A. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 500-mg extended-release (XR) fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500-mg FDC, in the fasted state (Treatment A)."
258515|NCT01365091|O4|Outcome|Arm 4: Treatments G,H/H,G|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fed state (Treatment G)."
258555|NCT01365039|P2|Participant Flow|Test Lens|"Test contact lens will be worn on a daily disposable wear basis.~Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
258516|NCT01365091|O3|Outcome|Arm 3: Treatments E,F/ F,E|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5- mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fasted state (Treatment E)."
258517|NCT01365091|O2|Outcome|Arm 2: Treatments C,D/D,C|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metforminXR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fed state (Treatment C)."
258518|NCT01365091|O1|Outcome|Arm 1: Treatments A,B/B,A|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg, tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fasted state (Treatment A)."
258519|NCT01365091|O4|Outcome|Sax, 5 mg/Met XR, 1000 mg: Sax, 5 mg/Met, 1000 mg FDC Fed|"Arm 4: Treatments G,H/H,G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fed state (Treatment G)."
258520|NCT01365091|O3|Outcome|Sax, 5 mg/Met XR, 1000 mg: Sax, 5 mg/Met, 1000 mg FDC Fasting|"Arm 3: Treatment E, F/F, G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 1000-mg tablets, together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fasted state (Treatment E)."
258521|NCT01365091|O2|Outcome|Sax, 5 mg/Met, 500 mg: Sax, 5 mg/Met 500 mg FDC Fed|"Arm 2: Treatment C, D/D, C. Period 1: Participants received a single oral dose of saxagliptin (sax) 5-mg/metformin (met) 500-mg, extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 500-mg XR FDC, in the fed state (Treatment C)."
258522|NCT01365091|O1|Outcome|Sax, 5 mg/Met, 500 mg: Sax, 5 mg/Met, 500 mg FDC Fasting|"Arm 1: Treatments A, B/B, A. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 500-mg extended-release (XR) fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500-mg FDC, in the fasted state (Treatment A)."
258523|NCT01365091|O4|Outcome|Sax, 5 mg/Met 1000 mg XR FDC to Individual Tablets, Fed|"Arm 4: Treatments G,H/H,G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fed state (Treatment G)."
258524|NCT01365091|O3|Outcome|Sax, 5 mg/Met 1000 mg XR FDC to Individual Tablets, Fasted|"Arm 3: Treatment E, F/F, G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 1000-mg tablets, together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fasted state (Treatment E)."
258617|NCT01364649|B3|Baseline|Total|Total of all reporting groups
258835|NCT01363661|O1|Outcome|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
258525|NCT01365091|O2|Outcome|Sax, 5 mg/Met 500 mg vs FDC to Individual Tablets, Fed|"Arm 2: Treatment C, D/D, C. Period 1: Participants received a single oral dose of saxagliptin (sax) 5-mg/metformin (met) 500-mg, extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 500-mg XR FDC, in the fed state (Treatment C)."
258526|NCT01365091|O1|Outcome|Sax, 5 mg/Met 500 mg XR FDC vs Individual Tablets, Fasted|"Arm 1: Treatments A, B/B, A. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 500-mg extended-release (XR) fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500-mg FDC, in the fasted state (Treatment A)."
258527|NCT01365091|E8|Reported Event|Saxagliptin, 5 mg/Metformin, 500 mg FDC Fed|FDC=fixed-dose combination
258528|NCT01365091|E7|Reported Event|Saxagliptin, 5 mg/Metformin, 500 mg FDC Fasting|FDC=fixed-dose combination
258529|NCT01365091|E6|Reported Event|Saxagliptin, 5 mg/Metformin, 1000 mg FDC Fed|FDC=fixed-dose combination
258530|NCT01365091|E5|Reported Event|Saxagliptin, 5 mg/Metformin, 1000 mg FDC Fasting|FDC=fixed-dose combination
258531|NCT01365091|E4|Reported Event|Saxagliptin, 5 mg/Metformin XR, 500 mg Fed|XR=extended release
258532|NCT01365091|E3|Reported Event|Saxagliptin, 5 mg/Metformin XR, 500 mg Fasting|XR=extended release
258533|NCT01365091|E2|Reported Event|Saxagliptin, 5 mg/Metformin XR, 1000 mg Fed|XR=extended release
258534|NCT01365091|E1|Reported Event|Saxagliptin, 5 mg/Metformin XR, 1000 mg Fasting|XR=extended release
258535|NCT01365052|B3|Baseline|Total|Total of all reporting groups
258536|NCT01365052|B2|Baseline|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
258537|NCT01365052|B1|Baseline|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
258538|NCT01365052|P2|Participant Flow|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
258539|NCT01365052|P1|Participant Flow|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
258540|NCT01365052|O2|Outcome|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
258541|NCT01365052|O1|Outcome|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
258542|NCT01365052|O2|Outcome|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
258543|NCT01365052|O1|Outcome|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
258544|NCT01365052|O2|Outcome|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
258545|NCT01365052|O1|Outcome|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
258546|NCT01365052|O2|Outcome|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
258547|NCT01365052|O1|Outcome|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
258548|NCT01365052|O2|Outcome|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
258549|NCT01365052|O1|Outcome|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
258550|NCT01365052|E2|Reported Event|Placebo|2 over-encapsulated tablets of placebo are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
258551|NCT01365052|E1|Reported Event|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
258552|NCT01365039|B3|Baseline|Total|Total of all reporting groups
258553|NCT01365039|B2|Baseline|Test Lens|"Test contact lens will be worn on a daily disposable wear basis.~Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
258554|NCT01365039|B1|Baseline|SofLens|"The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.~SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
258836|NCT01363661|O2|Outcome|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
258556|NCT01365039|P1|Participant Flow|SofLens Lens|"The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.~SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
258557|NCT01365039|O2|Outcome|Test Lens|"Test contact lens will be worn on a daily disposable wear basis.~Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
258558|NCT01365039|O1|Outcome|SofLens|"The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.~SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
258559|NCT01365039|O2|Outcome|Test Lens|"Test contact lens will be worn on a daily disposable wear basis.~Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
258560|NCT01365039|O1|Outcome|SofLens Lens|"The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.~SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
258561|NCT01365039|E2|Reported Event|Test Lens|"Test contact lens will be worn on a daily disposable wear basis.~Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
258562|NCT01365039|E1|Reported Event|SofLens Lens|"The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.~SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
258563|NCT01364922|B4|Baseline|Total|Total of all reporting groups
258564|NCT01364922|B3|Baseline|DB Placebo|1 placebo tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive placebo during the double-blind period.
258565|NCT01364922|B2|Baseline|DB Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive hydrocodone/acetaminophen extended release during the double-blind period.
258566|NCT01364922|B1|Baseline|OL Hydrocodone/Acetaminophen Extended Release (Nonrandomized)|2 hydrocodone/acetaminophen extended release tablets, twice daily, for 2 weeks. These participants enrolled in the study and received at least one dose of study drug during the open-label period; these participants were not randomized and did not progress to the double-blind period.
258567|NCT01364922|P3|Participant Flow|Double-blind Placebo|1 placebo tablet, twice daily, for 2 weeks.
258568|NCT01364922|P2|Participant Flow|Double-blind Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks.
258569|NCT01364922|P1|Participant Flow|Open-label Hydrocodone/Acetaminophen Extended Release|2 hydrocodone/acetaminophen extended release tablets, twice daily, for 2 weeks.
258570|NCT01364922|O2|Outcome|Double-blind Placebo|1 placebo tablet, twice daily, for 2 weeks.
258571|NCT01364922|O1|Outcome|Double-blind Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks.
258572|NCT01364922|O2|Outcome|Double-blind Placebo|1 placebo tablet, twice daily, for 2 weeks.
258573|NCT01364922|O1|Outcome|Double-blind Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks.
258574|NCT01364922|O2|Outcome|Double-blind Placebo|1 placebo tablet, twice daily, for 2 weeks.
258575|NCT01364922|O1|Outcome|Double-blind Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks.
258576|NCT01364922|E3|Reported Event|Double-blind Placebo|1 placebo tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive placebo during the double-blind period.
258577|NCT01364922|E2|Reported Event|Double-blind Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive hydrocodone/acetaminophen extended release during the double-blind period.
258578|NCT01364922|E1|Reported Event|Open-label Hydrocodone/Acetaminophen Extended Release|2 hydrocodone/acetaminophen extended release tablets, twice daily, for 2 weeks. These participants enrolled in the study and received at least one dose of study drug during the open-label period.
258579|NCT01364896|B1|Baseline|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent~Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:~Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)~High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria~Anal cytology testing"
258618|NCT01364649|B2|Baseline|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
258580|NCT01364896|P1|Participant Flow|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent~Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:~Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)~High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria~Anal cytology testing"
258581|NCT01364896|O1|Outcome|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent~Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:~Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)~High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria~Anal cytology testing"
258582|NCT01364896|O1|Outcome|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent~Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:~Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)~High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria~Anal cytology testing"
258583|NCT01364896|O1|Outcome|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent~Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:~Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)~High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria~Anal cytology testing"
258584|NCT01364896|O1|Outcome|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent~Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:~Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)~High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria~Anal cytology testing"
258585|NCT01364896|O1|Outcome|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent~Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:~Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)~High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria~Anal cytology testing"
258586|NCT01364896|E1|Reported Event|Inflammatory Bowel Disease, Immunosuppressive Agent|Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent
258587|NCT01364870|B4|Baseline|Total|Total of all reporting groups
258588|NCT01364870|B3|Baseline|Standard Care|"Subjects randomized to Standard Care will be given no TENS unit."
258589|NCT01364870|B2|Baseline|Placebo TENS|"Subjects randomized to the placebo group will use an EMPI TENS Select device that emits a current for 45 seconds then shuts off. They will be asked when they first feel the current, then the device will be turned down a half-point to provide treatment at a sub-sensory level. This unit displays an active indicator light suggesting to the subject that the unit is actively emitting current. At discharge, subject will be sent home with an adequate supply of batteries and asked to change batteries when the device goes below 4 bars, further suggesting that the device is actively working."
258590|NCT01364870|B1|Baseline|Intense TENS|"High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).~Intense TENS (EMPI Select TENS): High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs)."
258591|NCT01364870|P3|Participant Flow|Standard Care|"Subjects randomized to Standard Care will be given no TENS unit."
258592|NCT01364870|P2|Participant Flow|Placebo TENS|"Subjects randomized to the placebo group will use an EMPI TENS Select device that emits a current for 45 seconds then shuts off. They will be asked when they first feel the current, then the device will be turned down a half-point to provide treatment at a sub-sensory level. This unit displays an active indicator light suggesting to the subject that the unit is actively emitting current. At discharge, subject will be sent home with an adequate supply of batteries and asked to change batteries when the device goes below 4 bars, further suggesting that the device is actively working."
258593|NCT01364870|P1|Participant Flow|Intense TENS|"High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).~Intense TENS (EMPI Select TENS): High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs)."
258594|NCT01364870|O3|Outcome|Standard Care|"Subjects randomized to Standard Care will be given no TENS unit."
258595|NCT01364870|O2|Outcome|Placebo TENS|"Placebo TENS: Subjects randomized to the placebo group will use an EMPI TENS Select device that emits a current for 45 seconds then shuts off. They will be asked when they first feel the current, then the device will be turned down a half-point to provide treatment at a sub-sensory level. This unit displays an active indicator light suggesting to the subject that the unit is actively emitting current. At discharge, subject will be sent home with an adequate supply of batteries and asked to change batteries when the device goes below 4 bars, further suggesting that the device is actively working."
258596|NCT01364870|O1|Outcome|Intense TENS|"High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).~Intense TENS (EMPI Select TENS): High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs)."
258597|NCT01364870|O3|Outcome|Standard Care|"Subjects randomized to Standard Care will be given no TENS unit."
258598|NCT01364870|O2|Outcome|Placebo TENS|"Placebo TENS: Subjects randomized to the placebo group will use an EMPI TENS Select device that emits a current for 45 seconds then shuts off. They will be asked when they first feel the current, then the device will be turned down a half-point to provide treatment at a sub-sensory level. This unit displays an active indicator light suggesting to the subject that the unit is actively emitting current. At discharge, subject will be sent home with an adequate supply of batteries and asked to change batteries when the device goes below 4 bars, further suggesting that the device is actively working."
258599|NCT01364870|O1|Outcome|Intense TENS|"High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).~Intense TENS (EMPI Select TENS): High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs)."
258600|NCT01364870|E3|Reported Event|Standard Care|"Subjects randomized to Standard Care will be given no TENS unit."
258601|NCT01364870|E2|Reported Event|Placebo TENS|"Subjects randomized to the placebo group will use an EMPI TENS Select device that emits a current for 45 seconds then shuts off. They will be asked when they first feel the current, then the device will be turned down a half-point to provide treatment at a sub-sensory level. This unit displays an active indicator light suggesting to the subject that the unit is actively emitting current. At discharge, subject will be sent home with an adequate supply of batteries and asked to change batteries when the device goes below 4 bars, further suggesting that the device is actively working."
258602|NCT01364870|E1|Reported Event|Intense TENS|"High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).~Intense TENS (EMPI Select TENS): High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs)."
258603|NCT01364740|B1|Baseline|PMP-300E, In-Lab PSG|"PMP-300E, In-Lab PSG: PMP-300E, A 7-channel (nasal pressure, effort, snoring, SpO2, pulse rate, body position and movement) Level 3 portable monitor (11.2 x 3.3 x 5.5cm, 80g, Pacific Medico Co., LTD) to measure sleep-related breathing will be tested against conventional gold-standard In-Lab Polysomnography (sleep study)~PMP-300E: Data collected from Level 3 device~In-lab PSG: Data collected from Type I In-Lab Polysomnography"
258604|NCT01364740|P1|Participant Flow|SmartWatch PMP-300E|"Investigational device Smart Watch PMP-300E to measure sleep-related breathing was tested against conventional gold-standard In-Lab Polysomnography (sleep studies)~Smart Watch PMP-300E: Data collected from a Level 3 portable monitoring device~In-lab Polysomnography: Data collected from Type I In-Lab Polysomnography"
258605|NCT01364740|O1|Outcome|PMP-300E|Patient questionnaire data collected after one night with the PMP-300E
258606|NCT01364740|O1|Outcome|PMP-300E, In-Lab Polysomnography|Patient data from one night with the PMP-300E, compared to In-Lab PSG data
258607|NCT01364740|O1|Outcome|PMP-300E, In-Lab Polysomnography|Patient data from one night with the PMP-300E, compared to In-Lab PSG data
258608|NCT01364740|O1|Outcome|PMP-300E, In-Lab Polysomnography|Patient data from one night with the PMP-300E, compared to In-Lab PSG data
258609|NCT01364740|O1|Outcome|PMP-300E, In-Lab Polysomnography|Patient data from one night with the PMP-300E, compared to In-Lab PSG data
258610|NCT01364740|E1|Reported Event|PMP-300E, In-Lab Polysomnography|Patient data from one night with the PMP-300E, compared to In-Lab PSG data
258611|NCT01364727|B1|Baseline|Amrubicin|Amrubicin 35mg/m2 IV days 1-3 every 3 weeks until progression or toxicity
258612|NCT01364727|P1|Participant Flow|Amrubicin|Amrubicin 35mg/m2 IV days 1-3 every 3 weeks until progression or toxicity
258613|NCT01364727|O1|Outcome|Amrubicin|Amrubicin 35mg/m2 IV days 1-3 every 3 weeks until progression or toxicity
258614|NCT01364727|O1|Outcome|Amrubicin|Amrubicin 35mg/m2 IV days 1 to 3 every 3 weeks until progression or toxicity
258615|NCT01364727|O1|Outcome|Amrubicin|
258616|NCT01364727|E1|Reported Event|Amrubicin|Amrubicin 35mg/m2 IV days 1-3 every 3 weeks until progression or toxicity
258620|NCT01364649|P2|Participant Flow|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
258621|NCT01364649|P1|Participant Flow|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
258622|NCT01364649|O2|Outcome|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
258623|NCT01364649|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
258624|NCT01364649|O2|Outcome|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
258625|NCT01364649|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
258626|NCT01364649|O2|Outcome|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
258627|NCT01364649|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
258628|NCT01364649|E2|Reported Event|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
258629|NCT01364649|E1|Reported Event|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
258630|NCT01364558|B1|Baseline|Diazepam Nasal Spray Suspension/Spray/Injection|
258631|NCT01364558|P3|Participant Flow|Diazepam Injection|Diazepam injection
258632|NCT01364558|P2|Participant Flow|Diazepam Nasal Spray Solution|Diazepam Nasal Spray Solution
258633|NCT01364558|P1|Participant Flow|Diazepam Nasal Spray Suspension|Diazepam Nasal Spray Suspension
258634|NCT01364558|O3|Outcome|Diazepam Injection|Diazepam injection
258635|NCT01364558|O2|Outcome|Diazepam Nasal Spray Solution|Diazepam Nasal Spray Solution
258636|NCT01364558|O1|Outcome|Diazepam Nasal Spray Suspension|Diazepam Nasal Spray Suspension
258637|NCT01364558|E3|Reported Event|Diazepam Injection|
258638|NCT01364558|E2|Reported Event|Diazepam Nasal Spray Solution|
258639|NCT01364558|E1|Reported Event|Diazepam Nasal Spray Suspension|
258640|NCT01364428|B3|Baseline|Total|Total of all reporting groups
258641|NCT01364428|B2|Baseline|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
258642|NCT01364428|B1|Baseline|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
258643|NCT01364428|P2|Participant Flow|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
258644|NCT01364428|P1|Participant Flow|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
258645|NCT01364428|O2|Outcome|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
258646|NCT01364428|O1|Outcome|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
258647|NCT01364428|O2|Outcome|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
258648|NCT01364428|O1|Outcome|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
279175|NCT01303224|O1|Outcome|Ibodutant 1 mg|oral tablet, once daily
258649|NCT01364428|O2|Outcome|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
258650|NCT01364428|O1|Outcome|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
258651|NCT01364428|O2|Outcome|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
258652|NCT01364428|O1|Outcome|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
258653|NCT01364428|O2|Outcome|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
258654|NCT01364428|O1|Outcome|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
258655|NCT01364428|E2|Reported Event|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
258656|NCT01364428|E1|Reported Event|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
258657|NCT01364389|B4|Baseline|Total|Total of all reporting groups
258658|NCT01364389|B3|Baseline|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
258659|NCT01364389|B2|Baseline|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
258660|NCT01364389|B1|Baseline|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
258661|NCT01364389|P3|Participant Flow|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
258662|NCT01364389|P2|Participant Flow|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
258663|NCT01364389|P1|Participant Flow|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
258664|NCT01364389|O3|Outcome|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
258665|NCT01364389|O2|Outcome|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
258747|NCT01363908|B1|Baseline|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258666|NCT01364389|O1|Outcome|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
258667|NCT01364389|O3|Outcome|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
258668|NCT01364389|O2|Outcome|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
258669|NCT01364389|O1|Outcome|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
258670|NCT01364389|O3|Outcome|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
258671|NCT01364389|O2|Outcome|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
258672|NCT01364389|O1|Outcome|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
258673|NCT01364389|O3|Outcome|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
258674|NCT01364389|O2|Outcome|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
258675|NCT01364389|O1|Outcome|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
258676|NCT01364389|E3|Reported Event|Prednisone 20mg|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
258677|NCT01364389|E2|Reported Event|AIN457 3mg/kg|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
258678|NCT01364389|E1|Reported Event|ACZ885 3mg/kg|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
258679|NCT01364298|B3|Baseline|Total|Total of all reporting groups
258680|NCT01364298|B2|Baseline|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
258681|NCT01364298|B1|Baseline|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
258682|NCT01364298|P2|Participant Flow|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
279176|NCT01303224|O4|Outcome|Placebo|oral tablet, once daily
258683|NCT01364298|P1|Participant Flow|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
258684|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
258685|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
258686|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
258687|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
258688|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
258689|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
258690|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
258691|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
258692|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
258693|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
258694|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
258695|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
258696|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
258748|NCT01363908|P2|Participant Flow|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258697|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
258698|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
258699|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
258700|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
258701|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
258702|NCT01364298|E2|Reported Event|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
258703|NCT01364298|E1|Reported Event|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
258704|NCT01364259|B3|Baseline|Total|Total of all reporting groups
258705|NCT01364259|B2|Baseline|Amifostine|"Amifostine and CyberKnife stereotactic radiosurgery~CyberKnife stereotactic radiosurgery + amofostine"
258706|NCT01364259|B1|Baseline|Placebo|"Placebo and SRS~CyberKnife stereotactic radiosurgery + saline"
258707|NCT01364259|P2|Participant Flow|Amifostine|"Amifostine and SRS~CyberKnife stereotactic radiosurgery and Amifostine"
258708|NCT01364259|P1|Participant Flow|Placebo|"Placebo and SRS~CyberKnife stereotactic radiosurgery (srs)"
258709|NCT01364259|O2|Outcome|Amifostine|"Amifostine and SRS~CyberKnife stereotactic radiosurgery and Amifostine"
258710|NCT01364259|O1|Outcome|Placebo|"Placebo and SRS~CyberKnife stereotactic radiosurgery (srs)"
258711|NCT01364259|O2|Outcome|Amifostine|"Amifostine and SRS~CyberKnife stereotactic radiosurgery and Amifostine"
258712|NCT01364259|O1|Outcome|Placebo|"Placebo and SRS~CyberKnife stereotactic radiosurgery (srs)"
258713|NCT01364259|E2|Reported Event|Amifostine|"Amifostine and SRS~CyberKnife stereotactic radiosurgery and Amifostine"
258714|NCT01364259|E1|Reported Event|Placebo|"Placebo and SRS~CyberKnife stereotactic radiosurgery (srs)"
258715|NCT01364207|B1|Baseline|All Participants Who Completed Both Study Visits|Only those 106 participants who completed both study visits were included in baseline and final data analyses. The 6 participants who did not complete both study visits were not included in any baseline or final data analyses.
258716|NCT01364207|P2|Participant Flow|Decaffeinated Coffee 1st Visit, Caffeinated Coffee 2nd Visit|Participants drank an 8 oz cup of decaffeinated coffee on the their first visit, and then an 8 oz cup of caffeinated coffee on their second visit. The second visit was completed 2 days to 4 weeks after the first visit, depending on the participants' schedules. Participants did not ingest caffeine in any form starting from 12:01am the day of the visit until after the visit that day except for the study coffee we gave to them.
258717|NCT01364207|P1|Participant Flow|Caffeinated Coffee 1st Visit, Decaffeinated Coffee 2nd Visit|Participants drank an 8 oz cup of caffeinated coffee on the their first visit, and then an 8 oz cup of decaffeinated coffee on their second visit. The second visit was completed 2 days to 4 weeks after the first visit, depending on the participants' schedules. Participants did not ingest caffeine in any form starting from 12:01am the day of the visit until after the visit that day except for the study coffee we gave to them.
258718|NCT01364207|O2|Outcome|Decaffeinated Coffee|Participants drank an 8 oz cup of decaffeinated coffee.
258719|NCT01364207|O1|Outcome|Caffeinated Coffee|Participants drank an 8 oz cup of caffeinated coffee.
258720|NCT01364207|O2|Outcome|Decaffeinated Coffee|Participants drank an 8 oz cup of decaffeinated coffee.
258721|NCT01364207|O1|Outcome|Caffeinated Coffee|Participants drank an 8 oz cup of caffeinated coffee.
258722|NCT01364207|E2|Reported Event|Decaffeinated Coffee|Participants drank an 8 oz cup of decaffeinated coffee.
258723|NCT01364207|E1|Reported Event|Caffeinated Coffee|Participants drank an 8 oz cup of caffeinated coffee.
258724|NCT01364090|B4|Baseline|Total|Total of all reporting groups
258725|NCT01364090|B3|Baseline|Discontinued Prior to RVR|Participants who discontinued therapy prior to RVR assessment at week 4 and were therefore not placed in either study arms.
258820|NCT01363700|O2|Outcome|Placebo Ophthalmic Solution|Count unit was defined each eye.
258726|NCT01364090|B2|Baseline|Shortened Treatment Duration (12 Weeks)|"Subjects with undetectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total).~Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.~Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses."
258727|NCT01364090|B1|Baseline|Standard Treatment Duration (24 Weeks)|"Subjects with detectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total).~Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.~Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses."
258728|NCT01364090|P3|Participant Flow|Discontinued Prior to RVR|Participants who discontinued therapy prior to RVR assessment at week 4 and were therefore not placed in either study arms.
258729|NCT01364090|P2|Participant Flow|Shortened Treatment Duration (12 Weeks)|"Subjects with undetectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total).~Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.~Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses."
258730|NCT01364090|P1|Participant Flow|Standard Treatment Duration (24 Weeks)|"Subjects with detectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total).~Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.~Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses."
258731|NCT01364090|O3|Outcome|Discontinued Prior to RVR|Participants who discontinued therapy prior to RVR assessment at week 4 and were therefore not placed in either study arms.
258732|NCT01364090|O2|Outcome|Shortened Treatment Duration (12 Weeks)|"Subjects with undetectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total).~Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.~Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses."
258733|NCT01364090|O1|Outcome|Standard Treatment Duration (24 Weeks)|"Subjects with detectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total).~Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.~Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses."
258734|NCT01364090|E3|Reported Event|Discontinued Prior to RVR|Participants who discontinued therapy prior to RVR assessment at week 4 and were therefore not placed in either study arms.
258735|NCT01364090|E2|Reported Event|Shortened Treatment Duration (12 Weeks)|"Subjects with undetectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total).~Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.~Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses."
258736|NCT01364090|E1|Reported Event|Standard Treatment Duration (24 Weeks)|"Subjects with detectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total).~Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.~Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses."
258737|NCT01363986|B1|Baseline|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
258738|NCT01363986|P1|Participant Flow|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 milligrams per kilogram (mg/kg) trastuzumab intravenously (i.v.) on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
258739|NCT01363986|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
258740|NCT01363986|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
258741|NCT01363986|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
258742|NCT01363986|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
258743|NCT01363986|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
258744|NCT01363986|E1|Reported Event|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
258745|NCT01363908|B3|Baseline|Total|Total of all reporting groups
258746|NCT01363908|B2|Baseline|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258821|NCT01363700|O1|Outcome|Epinastine (DE-114) Ophthalmic Solution|Count unit was defined each eye.
258749|NCT01363908|P1|Participant Flow|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258750|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258751|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258752|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258753|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258754|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258755|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258756|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258757|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258758|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258759|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258760|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258761|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258762|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258763|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258764|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258765|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258766|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258822|NCT01363700|E5|Reported Event|Placebo Ophthalmic Solution Period2|Count unit was defined each eye.
258767|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258768|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258769|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258770|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258771|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258772|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258773|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258774|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258775|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258776|NCT01363908|E2|Reported Event|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258777|NCT01363908|E1|Reported Event|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
258778|NCT01363843|B1|Baseline|Study Arm|"Induction therapy - Modified FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV, followed by 5-FU 400 mg/m2 IV, followed 5-FU 2400 mg/m2 IV by continuous infusion over 46 hours - Repeat q14 days x 8 cycles~Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion starting the morning of the first dose of radiation and ending the morning after the last dose of radiation~Capecitabine 825 mg/m2 PO BID~50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)~Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)~Capecitabine"
258779|NCT01363843|P1|Participant Flow|Study Arm Only|"Induction therapy - Modified FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV, followed by 5-FU 400 mg/m2 IV, followed 5-FU 2400 mg/m2 IV by continuous infusion over 46 hours - Repeat q14 days x 8 cycles~Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion starting the morning of the first dose of radiation and ending the morning after the last dose of radiation~Capecitabine 825 mg/m2 PO BID~50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)~Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)~Capecitabine"
258780|NCT01363843|O1|Outcome|Study Arm Only|"Induction therapy - Modified FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV, followed by 5-FU 400 mg/m2 IV, followed 5-FU 2400 mg/m2 IV by continuous infusion over 46 hours - Repeat q14 days x 8 cycles~Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion starting the morning of the first dose of radiation and ending the morning after the last dose of radiation~Capecitabine 825 mg/m2 PO BID~50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)~Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)~Capecitabine"
279177|NCT01303224|O3|Outcome|Ibodutant 10 mg|oral tablet, once daily
258781|NCT01363843|E1|Reported Event|Study Arm Only|"Induction therapy - Modified FOLFOX6 - Repeat q14 days x 8 cycles~Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)~Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)~Capecitabine"
258782|NCT01363765|B3|Baseline|Total|Total of all reporting groups
258783|NCT01363765|B2|Baseline|Sputum Smear|Sputum smears arriving in the laboratory during the observation period will be submitted to the classic routine smear staining
258784|NCT01363765|B1|Baseline|Xpert MTB/Rif|One sample of sputum specimens arriving during intervention period were submitted to this technology instead, a real-time automated polymerase chain reaction test
258785|NCT01363765|P2|Participant Flow|Sputum Smear|Sputum smears arriving in the laboratory during the observation period were submitted to the classic routine AFB smear staining, as per national guidelines. Two smears were requested.
258786|NCT01363765|P1|Participant Flow|Xpert MTB/Rif|Sputum specimens arriving during intervention period were submitted to this technology, a real-time automated polymerase chain reaction test
258787|NCT01363765|O2|Outcome|Sputum Smear|Sputum smears arriving in the laboratory during the observation period will be submitted to the classic routine smear staining
258788|NCT01363765|O1|Outcome|Xpert MTB/Rif|One sample of sputum specimens arriving during intervention period were submitted to this technology instead, a real-time automated polymerase chain reaction test
258789|NCT01363765|O2|Outcome|Sputum Smear|Sputum smears arriving in the laboratory during the observation period will be submitted to the classic routine smear staining
258790|NCT01363765|O1|Outcome|Xpert MTB/Rif|One sample of sputum specimens arriving during intervention period were submitted to this technology instead, a real-time automated polymerase chain reaction test
258791|NCT01363765|O2|Outcome|Sputum Smear|Sputum smears arriving in the laboratory during the observation period will be submitted to the classic routine smear staining
258792|NCT01363765|O1|Outcome|Xpert MTB/Rif|One sample of sputum specimens arriving during intervention period were submitted to this technology instead, a real-time automated polymerase chain reaction test
258793|NCT01363765|O2|Outcome|Sputum Smear|Sputum smears arriving in the laboratory during the observation period were submitted to the classic routine smear staining
258794|NCT01363765|O1|Outcome|Xpert MTB/Rif|One sample of sputum specimens arriving during intervention period was submitted to this technology
258795|NCT01363765|E2|Reported Event|Sputum Smear|Sputum smears arriving in the laboratory during the observation period were submitted to the classic routine AFB smear staining, as per national guidelines. Two smears were requested.
258796|NCT01363765|E1|Reported Event|Xpert MTB/Rif|Sputum specimens arriving during intervention period were submitted to this technology, a real-time automated polymerase chain reaction test
258797|NCT01363713|B1|Baseline|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
258798|NCT01363713|P1|Participant Flow|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
258799|NCT01363713|O1|Outcome|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
258800|NCT01363713|O1|Outcome|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
258801|NCT01363713|O1|Outcome|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
258802|NCT01363713|E1|Reported Event|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
258803|NCT01363700|B4|Baseline|Total|Total of all reporting groups
258804|NCT01363700|B3|Baseline|Placebo / Placebo Period1|Placebo / Placebo : vehicle of DE-114 ophthalmic solution, 1 drop in each eye at designated visits.
258805|NCT01363700|B2|Baseline|Epinastine / Epinastine Period1|Epinastine / Epinastine : DE-114 ophthalmic solution, 1 drop in each eye at designated visits.
258806|NCT01363700|B1|Baseline|Epinastine / Placebo Period1|Epinastine / Placebo : DE-114 ophthalmic solution in one eye and vehicle of DE-114 ophthalmic solution in the other eye, Both eye received 1 drop at designated visits.
258807|NCT01363700|P5|Participant Flow|Epinastine / Placebo Period2|Epinastine / Placebo : Epinastine ophthalmic solution in one eye and vehicle of DE-114 ophthalmic solution in the other eye, Both eye received 1 drop at designated visits.
258808|NCT01363700|P4|Participant Flow|Olopatadine / Placebo Period2|Olopatadine / Placebo : Olopatadine ophthalmic solution in one eye and vehicle of DE-114 ophthalmic solution in the other eye, Both eye received 1 drop at designated visits.
258809|NCT01363700|P3|Participant Flow|Placebo / Placebo Period1|Placebo / Placebo : vehicle of DE-114 ophthalmic solution, 1 drop in each eye at designated visits.
258810|NCT01363700|P2|Participant Flow|Epinastine / Epinastine Period1|Epinastine / Epinastine : Epinastine ophthalmic solution, 1 drop in each eye at designated visits.
258811|NCT01363700|P1|Participant Flow|Epinastine / Placebo Period1|Epinastine / Placebo : Epinastine ophthalmic solution in one eye and vehicle of DE-114 ophthalmic solution in the other eye, Both eye received 1 drop at designated visits.
258812|NCT01363700|O3|Outcome|Placebo Ophthalmic Solution|Count unit was defined each eye.
258813|NCT01363700|O2|Outcome|Olopatadine Ophthalmic Solution|Count unit was defined each eye.
258814|NCT01363700|O1|Outcome|Epinastine (DE-114) Ophthalmic Solution|Count unit was defined each eye.
258815|NCT01363700|O3|Outcome|Placebo Ophthalmic Solution|Count unit was defined each eye.
258816|NCT01363700|O2|Outcome|Olopatadine Ophthalmic Solution|Count unit was defined each eye.
258817|NCT01363700|O1|Outcome|Epinastine (DE-114) Ophthalmic Solution|Count unit was defined each eye.
258818|NCT01363700|O2|Outcome|Placebo Ophthalmic Solution|Count unit was defined each eye.
258819|NCT01363700|O1|Outcome|Epinastine (DE-114) Ophthalmic Solution|Count unit was defined each eye.
258837|NCT01363661|O1|Outcome|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
258838|NCT01363661|O2|Outcome|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
258839|NCT01363661|O1|Outcome|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
258840|NCT01363661|O2|Outcome|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
258841|NCT01363661|O1|Outcome|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
258842|NCT01363661|O2|Outcome|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
258843|NCT01363661|O1|Outcome|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
258844|NCT01363661|E2|Reported Event|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
258845|NCT01363661|E1|Reported Event|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
258846|NCT01363492|B1|Baseline|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
258847|NCT01363492|P1|Participant Flow|Replagal® (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes every other week (EOW)
258848|NCT01363492|O1|Outcome|Replagal 0.2 mg/kg|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
258849|NCT01363492|O1|Outcome|Replagal 0.2 mg/kg|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
258850|NCT01363492|O1|Outcome|Replagal 0.2 mg/kg|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
258851|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
258852|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
258853|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
258854|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
258855|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
258856|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
258857|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes every other week (EOW)
258858|NCT01363492|E1|Reported Event|Replagal® (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
258859|NCT01363479|B3|Baseline|Total|Total of all reporting groups
258860|NCT01363479|B2|Baseline|I.V. Palonosetron Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~I.V. palonosetron~Dexamethasone"
258861|NCT01363479|B1|Baseline|Oral Palonosteron Plus Dexamethasone|"Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~Oral palonosetron~Dexamethasone"
258862|NCT01363479|P2|Participant Flow|I.V. Palonosetron Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~I.V. palonosetron~Dexamethasone"
258863|NCT01363479|P1|Participant Flow|Oral Palonosteron Plus Dexamethasone|"Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~Oral palonosetron~Dexamethasone"
258864|NCT01363479|O2|Outcome|I.V. Palonosetron Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~I.V. palonosetron~Dexamethasone"
258865|NCT01363479|O1|Outcome|Oral Palonosteron Plus Dexamethasone|"Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~Oral palonosetron~Dexamethasone"
258866|NCT01363479|E2|Reported Event|I.V. Palonosetron Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~I.V. palonosetron~Dexamethasone"
258867|NCT01363479|E1|Reported Event|Oral Palonosteron Plus Dexamethasone|"Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~Oral palonosetron~Dexamethasone"
258868|NCT01363440|B4|Baseline|Total|Total of all reporting groups
258869|NCT01363440|B3|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
258870|NCT01363440|B2|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
258871|NCT01363440|B1|Baseline|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
258872|NCT01363440|P3|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
258873|NCT01363440|P2|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
258874|NCT01363440|P1|Participant Flow|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
258875|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
279178|NCT01303224|O2|Outcome|Ibodutant 3 mg|oral tablet, once daily
258876|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
258877|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
258878|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
258879|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
258880|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
258881|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
258882|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
258883|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
258884|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
258885|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
258886|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
258887|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
258888|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
258889|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
258890|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
258891|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
258892|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
258893|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
258894|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
258895|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
258896|NCT01363440|E6|Reported Event|IAI;EYLEA®;BAY86-5321) 2Q8 (Week 0 to Week 148)|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
258897|NCT01363440|E5|Reported Event|IAI;EYLEA®;BAY86-5321 2Q4 (Week 0 to Week 148)|Participants received 2mg Intravitreal aflibercept injection(IAI) every 4 weeks.
258898|NCT01363440|E4|Reported Event|Control (Week 0 to Week 148)|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
258899|NCT01363440|E3|Reported Event|IAI;EYLEA®;BAY86-5321) 2Q8 (Week 0 to Week 100)|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
258900|NCT01363440|E2|Reported Event|IAI;EYLEA®;BAY86-5321 2Q4 (Week 0 to Week 100)|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
258901|NCT01363440|E1|Reported Event|Control (Week 0 to Week 100)|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
258902|NCT01363401|B3|Baseline|Total|Total of all reporting groups
258903|NCT01363401|B2|Baseline|No Treatment|"No treatment with HYNR-CS inj.~Take each 50mg 1 hour before a meal or 2 hours after a meal at least at an interval of 12 hours, 28 weeks(12 weeks of run-in phase plus 16 weeks of treatment phase)"
258904|NCT01363401|B1|Baseline|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.~intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
258905|NCT01363401|P2|Participant Flow|No Treatment|No treatment with HYNR-CS inj.
258906|NCT01363401|P1|Participant Flow|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.~intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
258907|NCT01363401|O2|Outcome|No Treatment|No treatment with HYNR-CS inj.
258908|NCT01363401|O1|Outcome|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.~intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
258909|NCT01363401|O2|Outcome|No Treatment|No treatment with HYNR-CS inj.
258910|NCT01363401|O1|Outcome|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.~intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
258911|NCT01363401|O2|Outcome|No Treatment|No treatment with HYNR-CS inj.
258912|NCT01363401|O1|Outcome|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.~intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
258913|NCT01363401|O2|Outcome|No Treatment|No treatment with HYNR-CS inj.
259516|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
258914|NCT01363401|O1|Outcome|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.~intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
258915|NCT01363401|E2|Reported Event|No Treatment|No treatment with HYNR-CS inj.
258916|NCT01363401|E1|Reported Event|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.~intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
258917|NCT01363349|B3|Baseline|Total|Total of all reporting groups
258918|NCT01363349|B2|Baseline|Risperidone|"2-6 mg, 6 months~Risperidone"
258919|NCT01363349|B1|Baseline|CYP-1020|CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
258920|NCT01363349|P2|Participant Flow|Risperidone|"2-6 mg, 6 months~Risperidone"
258921|NCT01363349|P1|Participant Flow|CYP-1020|CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
258922|NCT01363349|O2|Outcome|Risperidone|"2-6 mg, 6 months~Risperidone"
258923|NCT01363349|O1|Outcome|CYP-1020|CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
258924|NCT01363349|E2|Reported Event|Risperidone|"2-6 mg, 6 months~Risperidone"
258925|NCT01363349|E1|Reported Event|CYP-1020|CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
258926|NCT01363297|B6|Baseline|Total|Total of all reporting groups
258927|NCT01363297|B5|Baseline|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258928|NCT01363297|B4|Baseline|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258929|NCT01363297|B3|Baseline|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258930|NCT01363297|B2|Baseline|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258931|NCT01363297|B1|Baseline|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
258932|NCT01363297|P5|Participant Flow|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258933|NCT01363297|P4|Participant Flow|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258934|NCT01363297|P3|Participant Flow|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258935|NCT01363297|P2|Participant Flow|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258936|NCT01363297|P1|Participant Flow|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
258937|NCT01363297|O1|Outcome|Pharmacogenomics Population|All participants who gave consent for the optional blood sample for pharmacogenomic analyses, received at least 1 dose of any study drug, and had at least 1 biomarker parameter from the corresponding assay sample with both a baseline and post-treatment assessment.
258938|NCT01363297|O6|Outcome|All Doses|
258939|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258940|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258941|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258942|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258943|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
258944|NCT01363297|O6|Outcome|All Doses|
258945|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258946|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258947|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258948|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258949|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
258950|NCT01363297|O6|Outcome|All Doses|
258951|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
261083|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
258952|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258953|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258954|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258955|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
258956|NCT01363297|O6|Outcome|All Doses|
258957|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258958|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258959|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258960|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258961|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
258962|NCT01363297|O6|Outcome|All Doses|
258963|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258964|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258965|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258966|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258967|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
258968|NCT01363297|O6|Outcome|All Doses|
258969|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258970|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258971|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258972|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258973|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
258974|NCT01363297|O6|Outcome|All Doses|
258975|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258976|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258977|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258978|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258979|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
258980|NCT01363297|O6|Outcome|All Doses|
258981|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258982|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258983|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258984|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
259141|NCT01362907|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
258985|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
258986|NCT01363297|O6|Outcome|All Doses|
258987|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258988|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258989|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258990|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258991|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
258992|NCT01363297|O6|Outcome|All Doses|
258993|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258994|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258995|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258996|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
258997|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
258998|NCT01363297|O6|Outcome|All Doses|
258999|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
259000|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
259001|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
259002|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
259003|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
259004|NCT01363297|O1|Outcome|All Doses|
259005|NCT01363297|O6|Outcome|All Doses|
259006|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
259007|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
259008|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
259009|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
259010|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
259011|NCT01363297|O1|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
259012|NCT01363297|O1|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
259013|NCT01363297|O1|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
259014|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
259015|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
259016|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
259017|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
259142|NCT01362907|O2|Outcome|Etafilcon A|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
259018|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
259019|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
259020|NCT01363297|E5|Reported Event|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
259021|NCT01363297|E4|Reported Event|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
259022|NCT01363297|E3|Reported Event|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
259023|NCT01363297|E2|Reported Event|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
259024|NCT01363297|E1|Reported Event|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
259025|NCT01363076|B3|Baseline|Total|Total of all reporting groups
259026|NCT01363076|B2|Baseline|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
259027|NCT01363076|B1|Baseline|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
259028|NCT01363076|P2|Participant Flow|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
259029|NCT01363076|P1|Participant Flow|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
259030|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
259031|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
259032|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
259033|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
259034|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
259035|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
259036|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
259037|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
259038|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
259039|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
259040|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
259041|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
259042|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
259043|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
259044|NCT01363076|E2|Reported Event|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
259045|NCT01363076|E1|Reported Event|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
259046|NCT01363050|B1|Baseline|Ketorolac Tromethamine|Ketorolac tromethamine : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
259047|NCT01363050|P1|Participant Flow|Ketorolac Tromethamine|Ketorolac tromethamine : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
259048|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
259049|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
259050|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
259051|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
259052|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
259053|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
259143|NCT01362907|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
259054|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 1): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
259055|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 1) : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
259056|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 1) : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
259057|NCT01363050|E1|Reported Event|Ketorolac Tromethamine|Ketorolac tromethamine : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
259058|NCT01363011|B3|Baseline|Total|Total of all reporting groups
259059|NCT01363011|B2|Baseline|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
259060|NCT01363011|B1|Baseline|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
259061|NCT01363011|P2|Participant Flow|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to cobicistat (Tybost®; COBI) 150 mg, while continuing the other components of their ARV regimen (atazanavir (ATV) 300 mg or darunavir (DRV) 800 mg plus 2 nucleoside reverse transcriptase inhibitors (NRTI)) for up to 96 weeks. These 2 NRTIs may have included abacavir (ABC), lamivudine (3TC)/zidovudine (ZDV), didanosine (DDI), emtricitabine (FTC), ABC/3TC, 3TC, tenofovir disoproxil fumarate (TDF), or emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF), administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
259062|NCT01363011|P1|Participant Flow|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior antiretroviral (ARV) treatment and who were virologically unsuppressed at baseline initiated treatment with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) (150/150/200/300 mg) single-tablet regimen (STR) once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
259063|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
259064|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
259065|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
259066|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
259067|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
259068|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
259082|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
259069|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
259070|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
259071|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
259072|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
259073|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
259074|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
259075|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
259076|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
259077|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
259078|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
259079|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
259080|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
259081|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
259139|NCT01362907|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
259083|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
259084|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
259085|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
259086|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
259087|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
259088|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
259089|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
259090|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
259091|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
259092|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
259093|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
259094|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
259095|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
259140|NCT01362907|O2|Outcome|Etafilcon A|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
259096|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
259097|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
259098|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
259099|NCT01363011|E2|Reported Event|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTI) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
259100|NCT01363011|E1|Reported Event|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
259101|NCT01362946|B1|Baseline|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259102|NCT01362946|P2|Participant Flow|Standard Behavior Treatment Then Modified Behavior Treatment|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During the first four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. During the last four weeks of treatment, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments.
259103|NCT01362946|P1|Participant Flow|Modified Behavior Treatment Then Standard Behavior Treatment|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During the first four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During the last four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment.
259104|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons.
259105|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons.
259106|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259107|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259108|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259109|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259110|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259111|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259112|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259113|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259114|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259115|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259116|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259117|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259118|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259119|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259120|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259121|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259122|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
261084|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
259123|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259124|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259125|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259126|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259127|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259128|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259129|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259130|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259131|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259132|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
259133|NCT01362946|E2|Reported Event|Standard Behavior Treatment Then Modified Behavior Treatment|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During the first four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. During the last four weeks of treatment, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments.
259134|NCT01362946|E1|Reported Event|Modified Behavior Treatment Then Standard Behavior Treatment|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During the first four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During the last four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment.
259135|NCT01362907|B1|Baseline|Overall|All enrolled participants
259136|NCT01362907|P2|Participant Flow|Etafilcon A / Delefilcon A|Etafilcon A contact lenses worn first, with delefilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
259137|NCT01362907|P1|Participant Flow|Delefilcon A / Etafilcon A|Delefilcon A contact lenses worn first, with etafilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
259138|NCT01362907|O2|Outcome|Etafilcon A|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
259517|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
259144|NCT01362907|O2|Outcome|Etafilcon A|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
259145|NCT01362907|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
259146|NCT01362907|O2|Outcome|Etafilcon A|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
259147|NCT01362907|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
259148|NCT01362907|E2|Reported Event|Etafilcon A|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
259149|NCT01362907|E1|Reported Event|Delefilcon A|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
259150|NCT01362894|B1|Baseline|Overall|All enrolled and dispensed participants.
259151|NCT01362894|P2|Participant Flow|Etafilcon A / Nelfilcon A|Etafilcon A lenses worn first, with nelfilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
259152|NCT01362894|P1|Participant Flow|Nelfilcon A / Etafilcon A|Nelfilcon A lenses worn first, with etafilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
259153|NCT01362894|O2|Outcome|Etafilcon A|Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
259154|NCT01362894|O1|Outcome|Nelfilcon A|Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
259155|NCT01362894|O2|Outcome|Etafilcon A|Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
259156|NCT01362894|O1|Outcome|Nelfilcon A|Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
259157|NCT01362894|O2|Outcome|Etafilcon A|Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
259158|NCT01362894|O1|Outcome|Nelfilcon A|Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
259159|NCT01362894|O2|Outcome|Etafilcon A|Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
259160|NCT01362894|O1|Outcome|Nelfilcon A|Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
259161|NCT01362894|O2|Outcome|Etafilcon A|Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
259162|NCT01362894|O1|Outcome|Nelfilcon A|Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
259163|NCT01362894|E2|Reported Event|Etafilcon A|Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
259164|NCT01362894|E1|Reported Event|Nelfilcon A|Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
259165|NCT01362686|B4|Baseline|Total|Total of all reporting groups
259166|NCT01362686|B3|Baseline|Rivastigmine|"See intervention note.~Rivastigmine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
259167|NCT01362686|B2|Baseline|Galantamine|"See intervention note.~Galantamine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
259168|NCT01362686|B1|Baseline|Donepezil|"See intervention note.~Donepezil: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
259169|NCT01362686|P3|Participant Flow|Rivastigmine|"See intervention note.~Rivastigmine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
259170|NCT01362686|P2|Participant Flow|Galantamine|"See intervention note.~Galantamine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
259171|NCT01362686|P1|Participant Flow|Donepezil|"See intervention note.~Donepezil: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
259172|NCT01362686|O3|Outcome|Rivastigmine|"See intervention note.~Rivastigmine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
259173|NCT01362686|O2|Outcome|Galantamine|"See intervention note.~Galantamine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
259541|NCT01362049|B5|Baseline|Total|Total of all reporting groups
259174|NCT01362686|O1|Outcome|Donepezil|"See intervention note.~Donepezil: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
259175|NCT01362686|O3|Outcome|Rivastigmine|"See intervention note.~Rivastigmine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
259176|NCT01362686|O2|Outcome|Galantamine|"See intervention note.~Galantamine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
259177|NCT01362686|O1|Outcome|Donepezil|"See intervention note.~Donepezil: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
259178|NCT01362686|O3|Outcome|Rivastigmine|"See intervention note.~Rivastigmine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
259179|NCT01362686|O2|Outcome|Galantamine|"See intervention note.~Galantamine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
259180|NCT01362686|O1|Outcome|Donepezil|"See intervention note.~Donepezil: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
259181|NCT01362686|E3|Reported Event|Rivastigmine|"See intervention note.~Rivastigmine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
259182|NCT01362686|E2|Reported Event|Galantamine|"See intervention note.~Galantamine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
259183|NCT01362686|E1|Reported Event|Donepezil|"See intervention note.~Donepezil: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
259184|NCT01362608|B3|Baseline|Total|Total of all reporting groups
259185|NCT01362608|B2|Baseline|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
259186|NCT01362608|B1|Baseline|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
259187|NCT01362608|P2|Participant Flow|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
259188|NCT01362608|P1|Participant Flow|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
259189|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
259190|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
259191|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
259192|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
259193|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
259194|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
259195|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
259196|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
259197|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
259198|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
259199|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
261085|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
259200|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
259201|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
259202|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
259203|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
259204|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
259205|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
259206|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
259207|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
259208|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
259209|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
259210|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
259211|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
259212|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
259213|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
259214|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
259215|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
259216|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
259217|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
259218|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
259219|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
259220|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
259221|NCT01362608|E2|Reported Event|Triam 40mg im|Triam 40mg im
259222|NCT01362608|E1|Reported Event|ACZ885 150mg sc|ACZ885 150mg sc
259223|NCT01362530|B3|Baseline|Total|Total of all reporting groups
259224|NCT01362530|B2|Baseline|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
259225|NCT01362530|B1|Baseline|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
259226|NCT01362530|P2|Participant Flow|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
259227|NCT01362530|P1|Participant Flow|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
259228|NCT01362530|O2|Outcome|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
259229|NCT01362530|O1|Outcome|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
259230|NCT01362530|O2|Outcome|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
259231|NCT01362530|O1|Outcome|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
261086|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
259232|NCT01362530|O2|Outcome|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
259233|NCT01362530|O1|Outcome|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
259234|NCT01362530|O2|Outcome|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
259235|NCT01362530|O1|Outcome|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
259236|NCT01362530|E3|Reported Event|Aprepitant Regimen Cycles 2-6|Participants completing Cycle 1 from either the aprepitant or the control regimen who meet eligibility criteria: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg).
259237|NCT01362530|E2|Reported Event|Control Regimen Cycle 1|Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg).
259238|NCT01362530|E1|Reported Event|Aprepitant Regimen Cycle 1|Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg).
259239|NCT01362517|B1|Baseline|Quinvaxem|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen~One dose of Quinvaxem given at 2, 3 and 4 months of age"
259240|NCT01362517|P1|Participant Flow|Quinvaxem|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen~One dose of Quinvaxem given at 2, 3 and 4 months of age"
259241|NCT01362517|O1|Outcome|Quinvaxem|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen~One dose of Quinvaxem given at 2, 3 and 4 months of age"
259242|NCT01362517|O1|Outcome|Quinvaxem|
259243|NCT01362517|O1|Outcome|Quinvaxem|
259244|NCT01362517|E3|Reported Event|Third Dose|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen~One dose given at 4 months of age"
259245|NCT01362517|E2|Reported Event|Second Dose|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen~One dose given at 3 months of age"
259246|NCT01362517|E1|Reported Event|First Dose|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen~One dose given at 2 months of age"
259247|NCT01362491|B4|Baseline|Total|Total of all reporting groups
259248|NCT01362491|B3|Baseline|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259249|NCT01362491|B2|Baseline|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259250|NCT01362491|B1|Baseline|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
259251|NCT01362491|P3|Participant Flow|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259252|NCT01362491|P2|Participant Flow|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259253|NCT01362491|P1|Participant Flow|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
259254|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259425|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259255|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259256|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
259257|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259258|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259259|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
259260|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259261|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259262|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
259263|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259264|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259265|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
259266|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259267|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259268|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
259269|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259270|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259271|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
259272|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259273|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259274|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
259275|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259276|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259277|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
259278|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259279|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259280|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
259281|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259282|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259283|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
259284|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259506|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
259285|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259286|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
259287|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259288|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259289|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
259290|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259291|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259292|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
259293|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259294|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
259295|NCT01362491|O2|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259296|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
259297|NCT01362491|E3|Reported Event|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259298|NCT01362491|E2|Reported Event|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
259299|NCT01362491|E1|Reported Event|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
259300|NCT01362439|B1|Baseline|Paliperidone ER|Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
259301|NCT01362439|P1|Participant Flow|Paliperidone ER|Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
259302|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
259303|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
259304|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
259305|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
259306|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
259307|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
259308|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
259309|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
259310|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
259311|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
259312|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
259507|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
259313|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
259314|NCT01362439|E1|Reported Event|Paliperidone ER|Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
259315|NCT01362348|B1|Baseline|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
259316|NCT01362348|P1|Participant Flow|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 micro liters ) of the pazopanib ophthalmic solution 10 milligram per millimeter (mg/mL) via topical ocular route to the study eye at approximate 5 hour intervals four times a day (QID) during the non-sleep period for a duration of 12 weeks.
259317|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
259318|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
259319|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
259320|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
259321|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
259322|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
259323|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
259324|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
259325|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
259326|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
259327|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
259328|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
259329|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
259330|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
259331|NCT01362348|E1|Reported Event|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
259332|NCT01362296|B3|Baseline|Total|Total of all reporting groups
259333|NCT01362296|B2|Baseline|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
259334|NCT01362296|B1|Baseline|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
259381|NCT01362296|E2|Reported Event|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced.
259335|NCT01362296|P4|Participant Flow|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
259336|NCT01362296|P3|Participant Flow|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
259337|NCT01362296|P2|Participant Flow|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
259338|NCT01362296|P1|Participant Flow|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
259339|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
259340|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
259341|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
259342|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
259343|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
259344|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
259345|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
259346|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
259347|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
259348|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
259349|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
259422|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259350|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
259351|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
259352|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
259353|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
259354|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
259355|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
259356|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
259357|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
259358|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
259359|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
259360|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
259361|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
259362|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
259363|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
259364|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
259423|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259365|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
259366|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
259367|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
259368|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
259369|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
259370|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
259371|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
259372|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
259373|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
259374|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
259375|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
259376|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
259377|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
259378|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
259379|NCT01362296|E4|Reported Event|Docetaxel 75 mg/m^2 in CP|Participants who experienced disease progression in the RP were given the option of crossing over to docetaxel 75 mg/m^2 and continuing in the CP.
259380|NCT01362296|E3|Reported Event|GSK1120212 2 mg in CP|Participants who experienced disease progression in the RP were given the option of crossing over to GSK1120212 2 mg and continuing in the Cross-over Phase (CP).
259424|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259382|NCT01362296|E1|Reported Event|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced.
259383|NCT01362244|B3|Baseline|Total|Total of all reporting groups
259384|NCT01362244|B2|Baseline|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259385|NCT01362244|B1|Baseline|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion
259386|NCT01362244|P2|Participant Flow|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259387|NCT01362244|P1|Participant Flow|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259388|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259389|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259390|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259391|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259392|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259393|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259394|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259395|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259396|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259397|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259398|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259399|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259400|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259401|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259402|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259403|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259404|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259405|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259406|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259407|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259408|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259409|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259410|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259411|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259412|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259413|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259414|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259415|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259416|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259417|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259418|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259419|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259420|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259421|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
261087|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
259426|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259427|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259428|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259429|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259430|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259431|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259432|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259433|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259434|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259435|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259436|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259437|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259438|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259439|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259440|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259441|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259442|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259443|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259444|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259445|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259446|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259447|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259448|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259449|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259450|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259451|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259452|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259453|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259454|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
259455|NCT01362244|E2|Reported Event|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
259456|NCT01362244|E1|Reported Event|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion
259457|NCT01362205|B3|Baseline|Total|Total of all reporting groups
259458|NCT01362205|B2|Baseline|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.~Placebo: Sterile, clear saline 0.9%"
259459|NCT01362205|B1|Baseline|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.~Dexmedetomidine: See arm details"
259460|NCT01362205|P2|Participant Flow|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.~Placebo: Sterile, clear saline 0.9%"
259508|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
259509|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
259510|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
259511|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
259512|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
259461|NCT01362205|P1|Participant Flow|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.~Dexmedetomidine: See arm details"
259462|NCT01362205|O2|Outcome|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.~Placebo: Sterile, clear saline 0.9%"
259463|NCT01362205|O1|Outcome|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.~Dexmedetomidine: See arm details"
259464|NCT01362205|O2|Outcome|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.~Placebo: Sterile, clear saline 0.9%"
259465|NCT01362205|O1|Outcome|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.~Dexmedetomidine: See arm details"
259466|NCT01362205|O2|Outcome|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.~Placebo: Sterile, clear saline 0.9%"
259467|NCT01362205|O1|Outcome|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.~Dexmedetomidine: See arm details"
259468|NCT01362205|O2|Outcome|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.~Placebo: Sterile, clear saline 0.9%"
259469|NCT01362205|O1|Outcome|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.~Dexmedetomidine: See arm details"
259470|NCT01362205|O2|Outcome|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.~Placebo: Sterile, clear saline 0.9%"
259471|NCT01362205|O1|Outcome|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.~Dexmedetomidine: See arm details"
259472|NCT01362205|O2|Outcome|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.~Placebo: Sterile, clear saline 0.9%"
259473|NCT01362205|O1|Outcome|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.~Dexmedetomidine: See arm details"
259474|NCT01362205|O2|Outcome|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.~Placebo: Sterile, clear saline 0.9%"
259475|NCT01362205|O1|Outcome|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.~Dexmedetomidine: See arm details"
259476|NCT01362205|O2|Outcome|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.~Placebo: Sterile, clear saline 0.9%"
259513|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
259477|NCT01362205|O1|Outcome|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.~Dexmedetomidine: See arm details"
259478|NCT01362205|O2|Outcome|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.~Placebo: Sterile, clear saline 0.9%"
259479|NCT01362205|O1|Outcome|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.~Dexmedetomidine: See arm details"
259480|NCT01362205|O2|Outcome|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.~Placebo: Sterile, clear saline 0.9%"
259481|NCT01362205|O1|Outcome|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.~Dexmedetomidine: See arm details"
259482|NCT01362205|O2|Outcome|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.~Placebo: Sterile, clear saline 0.9%"
259483|NCT01362205|O1|Outcome|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.~Dexmedetomidine: See arm details"
259484|NCT01362205|E2|Reported Event|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.~Placebo: Sterile, clear saline 0.9%"
259485|NCT01362205|E1|Reported Event|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.~Dexmedetomidine: See arm details"
259486|NCT01362192|B1|Baseline|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
259487|NCT01362192|P1|Participant Flow|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
259488|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
259489|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
259490|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
259491|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
259492|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
259493|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
259494|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
259495|NCT01362192|E1|Reported Event|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
259496|NCT01362140|B3|Baseline|Total|Total of all reporting groups
259497|NCT01362140|B2|Baseline|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
259498|NCT01362140|B1|Baseline|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
259499|NCT01362140|P2|Participant Flow|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
259500|NCT01362140|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
259501|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
259502|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
259503|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
259504|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
259505|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
261088|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
259518|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
259519|NCT01362140|E2|Reported Event|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
259520|NCT01362140|E1|Reported Event|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
259521|NCT01362062|B3|Baseline|Total|Total of all reporting groups
259522|NCT01362062|B2|Baseline|RA Cohort (Retrospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed retrospectively for a total duration of 12 months.
259523|NCT01362062|B1|Baseline|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
259524|NCT01362062|P2|Participant Flow|RA Cohort (Retrospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed retrospectively for a total duration of 12 months.
259525|NCT01362062|P1|Participant Flow|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic disease modifying anti-rheumatoid drug (DMARD) and/or anti-tumor necrosis factor (anti-TNF) therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
259526|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
259527|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
259528|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
259529|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
259530|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
259531|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
259532|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
259533|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
259534|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
259535|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
259536|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
259537|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
259538|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
259539|NCT01362062|O1|Outcome|RA Cohort (Prospective + Retrospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.
259540|NCT01362062|E1|Reported Event|RA Cohort (Prospective + Retrospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.
259542|NCT01362049|B4|Baseline|'Ineligible' Subject Group - STAB Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria.~Received STAB treatment"
259543|NCT01362049|B3|Baseline|'Ineligible' Subject Group - MSI Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria.~Received MSI-match treatment"
259544|NCT01362049|B2|Baseline|'Eligible' Subject Group - STAB Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level. Received STAB treatment"
259545|NCT01362049|B1|Baseline|'Eligible' Subject Group - MSI Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level. Received MSI-match treatment"
259546|NCT01362049|P4|Participant Flow|'Ineligible' Subject Group – STAB Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria.~Received STAB treatment"
259547|NCT01362049|P3|Participant Flow|'Ineligible' Subject Group - MSI Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria.~Received MSI- matched treatment"
259548|NCT01362049|P2|Participant Flow|'Eligible' Subject Group - STAB Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level. Received STAB treatment"
259549|NCT01362049|P1|Participant Flow|'Eligible' Subject Group - MSI Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level. Received MSI match treatment"
259550|NCT01362049|O4|Outcome|'Ineligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
259551|NCT01362049|O3|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises.
259552|NCT01362049|O2|Outcome|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level.~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
259553|NCT01362049|O1|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises
259554|NCT01362049|O4|Outcome|'Ineligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
259555|NCT01362049|O3|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises.
259556|NCT01362049|O2|Outcome|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level.~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
259557|NCT01362049|O1|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises.
259558|NCT01362049|O4|Outcome|'Ineligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
259559|NCT01362049|O3|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises
259560|NCT01362049|O2|Outcome|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level.~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
259561|NCT01362049|O1|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises
259562|NCT01362049|O4|Outcome|'Ineligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
259563|NCT01362049|O3|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises
259564|NCT01362049|O2|Outcome|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level.~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
259565|NCT01362049|O1|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises.
259566|NCT01362049|O4|Outcome|'Ineligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
259567|NCT01362049|O3|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises.
259568|NCT01362049|O2|Outcome|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level.~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
259569|NCT01362049|O1|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises.
259570|NCT01362049|O4|Outcome|'Ineligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
259571|NCT01362049|O3|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises.
259572|NCT01362049|O2|Outcome|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level.~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
259573|NCT01362049|O1|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises
259574|NCT01362049|O4|Outcome|'Ineligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
259575|NCT01362049|O3|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises.
259576|NCT01362049|O2|Outcome|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level.~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
259577|NCT01362049|O1|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises.
259578|NCT01362049|O4|Outcome|'Ineligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
259579|NCT01362049|O3|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises for treatment.
259580|NCT01362049|O2|Outcome|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level.~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
259581|NCT01362049|O1|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises for treatment
259582|NCT01362049|E4|Reported Event|'Ineligible' Subject Group - STAB Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria.~Received STAB treatment"
259583|NCT01362049|E3|Reported Event|'Ineligible' Subject Group - MSI Treatment|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria Received MSI-matched treatment
259584|NCT01362049|E2|Reported Event|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level. Received STAB treatment"
259585|NCT01362049|E1|Reported Event|'Eligible' Subject Group - MSI Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level. Received MSI-matched treatment"
259586|NCT01361867|B1|Baseline|Robot-induced Perturbations|"The subject walks on a treadmill with his/her legs strapped to a robotic system (Lokomat by Hocoma AG) that generates mechanical perturbations aimed to modify the subject's walking pattern.~Robot-induced perturbations: A robotic system is used to generate mechanical perturbations and study how subjects generate motor adaptations in response to the mechanical perturbations."
259587|NCT01361867|P1|Participant Flow|Robot-induced Perturbations|"The subject walks on a treadmill with his/her legs strapped to a robotic system (Lokomat by Hocoma AG) that generates mechanical perturbations aimed to modify the subject's walking pattern.~Robot-induced perturbations: A robotic system is used to generate mechanical perturbations and study how subjects generate motor adaptations in response to the mechanical perturbations."
259588|NCT01361867|O1|Outcome|Robot-induced Perturbations|"The subject walks on a treadmill with his/her legs strapped to a robotic system (Lokomat by Hocoma AG) that generates mechanical perturbations aimed to modify the subject's walking pattern.~Robot-induced perturbations: A robotic system is used to generate mechanical perturbations and study how subjects generate motor adaptations in response to the mechanical perturbations."
259589|NCT01361867|O1|Outcome|Robot-induced Perturbations|"The subject walks on a treadmill with his/her legs strapped to a robotic system (Lokomat by Hocoma AG) that generates mechanical perturbations aimed to modify the subject's walking pattern.~Robot-induced perturbations: A robotic system is used to generate mechanical perturbations and study how subjects generate motor adaptations in response to the mechanical perturbations."
259590|NCT01361867|E1|Reported Event|Robot-induced Perturbations|"The subject walks on a treadmill with his/her legs strapped to a robotic system (Lokomat by Hocoma AG) that generates mechanical perturbations aimed to modify the subject's walking pattern.~Robot-induced perturbations: A robotic system is used to generate mechanical perturbations and study how subjects generate motor adaptations in response to the mechanical perturbations."
259591|NCT01361854|B1|Baseline|Polysomnography for Suspicion of SDB|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography: home-based polysomnography with hook-up performed ar at home or in the hospital"
259592|NCT01361854|P2|Participant Flow|Hospital Hook-up First, Then Home Hook-up|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography: home-based polysomnography with hook-up performed at the hospital Croosover design. 2nd polysomnography with home hook-up performed within 2 weeks"
259593|NCT01361854|P1|Participant Flow|Home Hook-up First Then Hook-up in the Hospital|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography: home-based polysomnography with hook-up performed at home first.~Croosover design. 2nd polysomnography with in-lab hook-up performed within 2 weeks"
259594|NCT01361854|O2|Outcome|Lab Hook up First|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography:home polysomnography with in-lab hook up first"
259595|NCT01361854|O1|Outcome|Home Hook up First|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography: home-based polysomnography with home hook-up first"
259596|NCT01361854|E2|Reported Event|Lab Hook up First|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography: home-based polysomnography with hook-up performed in the sleep lab"
259597|NCT01361854|E1|Reported Event|Home Hook up First|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography: home-based polysomnography with hook-up performed at home"
259598|NCT01361633|B3|Baseline|Total|Total of all reporting groups
259599|NCT01361633|B2|Baseline|Sugar Pill|Placebo Control
259600|NCT01361633|B1|Baseline|Medication|250 mg d-cycloserine
259601|NCT01361633|P2|Participant Flow|Sugar Pill|Placebo Control
259602|NCT01361633|P1|Participant Flow|Medication|250 mg d-cycloserine
259603|NCT01361633|O2|Outcome|Sugar Pill|Placebo control
259604|NCT01361633|O1|Outcome|Medication|250mg d-cycloserine
259605|NCT01361633|E2|Reported Event|Sugar Pill|Placebo Control
259606|NCT01361633|E1|Reported Event|Medication|250 mg d-cycloserine
259607|NCT01361620|B1|Baseline|Aspirin|All subjects took 7-10 days of 81 mg aspirin
259608|NCT01361620|P1|Participant Flow|Aspirin|All subjects took 7-10 days of 81 mg aspirin
259609|NCT01361620|O1|Outcome|Aspirin|All subjects took 7-10 days of 81 mg aspirin
259610|NCT01361620|E1|Reported Event|Aspirin|All subjects took 7-10 days of 81 mg aspirin
259611|NCT01361607|B3|Baseline|Total|Total of all reporting groups
259612|NCT01361607|B2|Baseline|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
259613|NCT01361607|B1|Baseline|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
259614|NCT01361607|P2|Participant Flow|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
259615|NCT01361607|P1|Participant Flow|Nabiximols|Nabiximols was self-administered by participants as a 100 microliter (μL) oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained delta-9-tetrahydrocannabinol (THC) (27 milligram [mg]/milliliter [mL]):cannabidiol (CBD) (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
259616|NCT01361607|O2|Outcome|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
261089|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
259617|NCT01361607|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
259618|NCT01361607|O2|Outcome|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
259619|NCT01361607|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
259620|NCT01361607|O2|Outcome|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
259621|NCT01361607|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
259622|NCT01361607|O2|Outcome|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
259623|NCT01361607|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
259624|NCT01361607|O2|Outcome|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
259625|NCT01361607|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
259626|NCT01361607|O2|Outcome|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
259627|NCT01361607|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
259628|NCT01361607|O2|Outcome|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
259629|NCT01361607|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
259630|NCT01361607|O2|Outcome|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
259631|NCT01361607|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
259632|NCT01361607|O2|Outcome|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
259633|NCT01361607|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
259634|NCT01361607|O2|Outcome|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
259635|NCT01361607|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray, up to a maximum of 10 sprays per day in the morning and evening, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
259676|NCT01361568|O2|Outcome|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
259677|NCT01361568|O1|Outcome|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
259636|NCT01361607|O2|Outcome|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
259637|NCT01361607|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
259638|NCT01361607|E2|Reported Event|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
259639|NCT01361607|E1|Reported Event|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
259640|NCT01361594|B3|Baseline|Total|Total of all reporting groups
259641|NCT01361594|B2|Baseline|Conventional Insulin Treatment|"Conventional insulin treatment (BG target: 141-180 mg/dl)~Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl"
259642|NCT01361594|B1|Baseline|Intensive Insulin Treatment|"Intensive insulin treatment (BG target: 100-140 mg/dL)~Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL"
259643|NCT01361594|P2|Participant Flow|Conventional Insulin Treatment|"Conventional insulin treatment (BG target: 141-180 mg/dl)~Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl"
259644|NCT01361594|P1|Participant Flow|Intensive Insulin Treatment|"Intensive insulin treatment (BG target: 100-140 mg/dL)~Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL"
259645|NCT01361594|O2|Outcome|Conventional Insulin Treatment|"Conventional insulin treatment (BG target: 141-180 mg/dl)~Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl"
259646|NCT01361594|O1|Outcome|Intensive Insulin Treatment|"Intensive insulin treatment (BG target: 100-140 mg/dL)~Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL"
259647|NCT01361594|O2|Outcome|Conventional Insulin Treatment|"Conventional insulin treatment (BG target: 141-180 mg/dl)~Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl"
259648|NCT01361594|O1|Outcome|Intensive Insulin Treatment|"Intensive insulin treatment (BG target: 100-140 mg/dL)~Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL"
259649|NCT01361594|E2|Reported Event|Conventional Insulin Treatment|"Conventional insulin treatment (BG target: 141-180 mg/dl)~Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl"
259650|NCT01361594|E1|Reported Event|Intensive Insulin Treatment|"Intensive insulin treatment (BG target: 100-140 mg/dL)~Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL"
259651|NCT01361568|B7|Baseline|Total|Total of all reporting groups
259652|NCT01361568|B6|Baseline|Placebo-No Postoperative Treatment|Placebo administered preoperatively and no study drug administered postoperatively
259653|NCT01361568|B5|Baseline|CR845-No Postoperative Treatment|CR845 administered preoperatively and no study drug administered postoperatively
259654|NCT01361568|B4|Baseline|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
259655|NCT01361568|B3|Baseline|CR845-CR845|CR845 administered both preoperatively and postoperatively
259656|NCT01361568|B2|Baseline|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
259657|NCT01361568|B1|Baseline|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
259658|NCT01361568|P6|Participant Flow|Placebo-No Postoperative Treatment|Placebo administered preoperatively and no study drug administered postoperatively
259659|NCT01361568|P5|Participant Flow|CR845-No Postoperative Treatment|CR845 administered preoperatively and no study drug administered postoperatively
259660|NCT01361568|P4|Participant Flow|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
259661|NCT01361568|P3|Participant Flow|CR845-CR845|CR845 administered both preoperatively and postoperatively
259662|NCT01361568|P2|Participant Flow|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
259663|NCT01361568|P1|Participant Flow|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
259664|NCT01361568|O2|Outcome|CR845|Patients administered CR845 either preoperatively and/or postoperatively
259665|NCT01361568|O1|Outcome|Placebo|Patients administered placebo only, either preoperatively and/or postoperatively
259666|NCT01361568|O2|Outcome|CR845|Patients administered CR845 either preoperatively and/or postoperatively
259667|NCT01361568|O1|Outcome|Placebo|Patients administered placebo only, either preoperatively and/or postoperatively
259668|NCT01361568|O2|Outcome|CR845|Patients administered CR845 either preoperatively and/or postoperatively
259669|NCT01361568|O1|Outcome|Placebo|Patients administered placebo only either preoperatively and/or postoperatively
259670|NCT01361568|O4|Outcome|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
259671|NCT01361568|O3|Outcome|CR845-CR845|CR845 administered both preoperatively and postoperatively
259672|NCT01361568|O2|Outcome|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
259673|NCT01361568|O1|Outcome|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
259674|NCT01361568|O4|Outcome|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
259675|NCT01361568|O3|Outcome|CR845-CR845|CR845 administered both preoperatively and postoperatively
261090|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
259678|NCT01361568|O4|Outcome|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
259679|NCT01361568|O3|Outcome|CR845-CR845|CR845 administered both preoperatively and postoperatively
259680|NCT01361568|O2|Outcome|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
259681|NCT01361568|O1|Outcome|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
259682|NCT01361568|O4|Outcome|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
259683|NCT01361568|O3|Outcome|CR845-CR845|CR845 administered both preoperatively and postoperatively
259684|NCT01361568|O2|Outcome|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
259685|NCT01361568|O1|Outcome|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
259686|NCT01361568|E6|Reported Event|Placebo-No Postoperative Treatment|Placebo administered preoperatively and no study drug administered postoperatively
259687|NCT01361568|E5|Reported Event|CR845-No Postoperative Treatment|CR845 administered preoperatively and no study drug administered postoperatively
259688|NCT01361568|E4|Reported Event|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
259689|NCT01361568|E3|Reported Event|CR845-CR845|CR845 administered both preoperatively and postoperatively
259690|NCT01361568|E2|Reported Event|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
259691|NCT01361568|E1|Reported Event|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
259692|NCT01361464|B1|Baseline|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
259693|NCT01361464|P1|Participant Flow|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
259694|NCT01361464|O1|Outcome|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
259695|NCT01361464|O1|Outcome|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
259696|NCT01361464|O1|Outcome|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
259697|NCT01361464|O1|Outcome|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
259698|NCT01361464|E1|Reported Event|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
259699|NCT01361308|B3|Baseline|Total|Total of all reporting groups
259700|NCT01361308|B2|Baseline|Placebo Capsules|Subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
259701|NCT01361308|B1|Baseline|Brisdelle (Paroxetine Mesylate) Capsules|Subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
259702|NCT01361308|P2|Participant Flow|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
259703|NCT01361308|P1|Participant Flow|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
259704|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
259705|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
259706|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
259707|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
259708|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
259709|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
259710|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
259711|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
259712|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
259713|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
259714|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
259715|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
279179|NCT01303224|O1|Outcome|Ibodutant 1 mg|oral tablet, once daily
259716|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
259717|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
259718|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
259719|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
259720|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
259721|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
259722|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
259723|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
259724|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
259725|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
259726|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
259727|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
259728|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
259729|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
259730|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
259731|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
259732|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
259733|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
259734|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
259735|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
259736|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
259737|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
259738|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
259739|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
259740|NCT01361308|E2|Reported Event|Placebo Capsules|Subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
259741|NCT01361308|E1|Reported Event|Brisdelle (Paroxetine Mesylate) Capsules|Subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
259742|NCT01361178|B3|Baseline|Total|Total of all reporting groups
259743|NCT01361178|B2|Baseline|Transplant Patients Who Receive SQ IVIG|"Patients participating in the observational arm of the study who are randomized to receive a dosage of SQ IVIG due to low IgG level.~SQ IVIG: Group 1 will receive SQ IgG at the lower end of the dosing range at 100 mg/kg/week and group 2 will receive SQ IgG at the higher end of the dosing range at 200 mg/kg/week"
259744|NCT01361178|B1|Baseline|Transplant Patients Who do Not Receive SQ IVIG|Patients participating in the observational arm of the study who do not need to receive IgG replacement.
259745|NCT01361178|P2|Participant Flow|Transplant Patients Who Receive SQ IVIG|"Patients participating in the observational arm of the study who are randomized to receive a dosage of SQ IVIG due to low IgG level.~SQ IVIG: Group 1 will receive SQ IgG at the lower end of the dosing range at 100 mg/kg/week and group 2 will receive SQ IgG at the higher end of the dosing range at 200 mg/kg/week"
259778|NCT01361048|B3|Baseline|Neo Penotran Forte Once a Day|neo penotran forte vaginal suppository once a day for 7 days
259746|NCT01361178|P1|Participant Flow|Transplant Patients Who do Not Receive SQ IVIG|Patients participating in the observational arm of the study who do not need to receive IgG replacement.
259747|NCT01361178|O2|Outcome|Transplant Patients Who Receive SQ IVIG|"Patients participating in the observational arm of the study who are randomized to receive a dosage of SQ IVIG due to low IgG level.~SQ IVIG: Group 1 will receive SQ IgG at the lower end of the dosing range at 100 mg/kg/week and group 2 will receive SQ IgG at the higher end of the dosing range at 200 mg/kg/week"
259748|NCT01361178|O1|Outcome|Transplant Patients Who do Not Receive SQ IVIG|Patients participating in the observational arm of the study who do not need to receive IgG replacement.
259749|NCT01361178|E2|Reported Event|Transplant Patients Who Receive SQ IVIG|"Patients participating in the observational arm of the study who are randomized to receive a dosage of SQ IVIG due to low IgG level.~SQ IVIG: Group 1 will receive SQ IgG at the lower end of the dosing range at 100 mg/kg/week and group 2 will receive SQ IgG at the higher end of the dosing range at 200 mg/kg/week"
259750|NCT01361178|E1|Reported Event|Transplant Patients Who do Not Receive SQ IVIG|Patients participating in the observational arm of the study who do not need to receive IgG replacement.
259751|NCT01361126|B3|Baseline|Total|Total of all reporting groups
259752|NCT01361126|B2|Baseline|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg. After completion of the PK evaluation period, subjects entered the treatment period and were administered 1 or more IV infusions of rIX-FP at a dose of at least 25 IU/kg to treat minor, moderate or major bleeding episodes. The dose of rIX-FP was calculated by the investigator.
259753|NCT01361126|B1|Baseline|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg. After completion of the PK evaluation period, subjects entered the treatment period and were administered a single IV infusion of rIX-FP once a week at a dose of 15 to 35 IU/kg, or at a dose determined by the investigator. The dose was adjusted up to 75 IU/kg to maintain the trough FIX activity level > 1% between infusions.
259754|NCT01361126|P2|Participant Flow|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg. After completion of the PK evaluation period, subjects entered the treatment period and were administered 1 or more IV infusions of rIX-FP at a dose of at least 25 IU/kg to treat minor, moderate or major bleeding episodes. The dose of rIX-FP was calculated by the investigator.
259755|NCT01361126|P1|Participant Flow|Prophylactic|For the PK evaluation, subjects received a single intravenous (IV) infusion of Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) at a dose of 25 IU/kg. After completion of the PK evaluation period, subjects entered the treatment period and were administered a single IV infusion of rIX-FP once a week at a dose of 15 to 35 IU/kg, or at a dose determined by the investigator. The dose was adjusted up to 75 IU/kg to maintain the trough FIX activity level > 1% between infusions.
259756|NCT01361126|O1|Outcome|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg. After completion of the PK evaluation period, subjects entered the treatment period and were administered a single IV infusion of rIX-FP once a week at a dose of 15 to 35 IU/kg, or at a dose determined by the investigator. The dose was adjusted up to 75 IU/kg to maintain the trough FIX activity level > 1% between infusions.
259757|NCT01361126|O2|Outcome|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
259758|NCT01361126|O1|Outcome|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
259759|NCT01361126|O2|Outcome|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
259760|NCT01361126|O1|Outcome|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
259761|NCT01361126|O2|Outcome|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
259762|NCT01361126|O1|Outcome|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
259763|NCT01361126|O2|Outcome|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
259764|NCT01361126|O1|Outcome|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
259765|NCT01361126|O1|Outcome|All Subjects|Subjects received rIX-FP as prophylactic treatment once a week or on-demand to treat bleeding episodes administered by IV infusion for 20 weeks.
259766|NCT01361126|O1|Outcome|All Subjects|Subjects received rIX-FP as prophylactic treatment once a week or on-demand to treat bleeding episodes administered by IV infusion for 20 weeks.
259767|NCT01361126|O1|Outcome|All Subjects|Subjects received rIX-FP as prophylactic treatment once a week or on-demand to treat bleeding episodes administered by IV infusion for 20 weeks.
259768|NCT01361126|E1|Reported Event|All Subjects|Subjects received rIX-FP administered by IV infusion as prophylactic treatment once a week or on demand to treat bleeding episodes for 20 weeks.
259769|NCT01361113|B1|Baseline|Single Arm Neoadjuvant Pazopanib|"Pazopanib 800 mg PO once daily for 8 weeks~Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy"
259770|NCT01361113|P1|Participant Flow|Single Arm Neoadjuvant Pazopanib|"Pazopanib 800 mg PO once daily for 8 weeks~Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy"
259771|NCT01361113|O1|Outcome|Single Arm Neoadjuvant Pazopanib|"Pazopanib 800 mg PO once daily for 8 weeks~Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy"
259772|NCT01361113|O1|Outcome|Single Arm Neoadjuvant Pazopanib|"Pazopanib 800 mg PO once daily for 8 weeks~Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy"
259773|NCT01361113|O2|Outcome|2 Year Recurrence Free Survival|"Single Arm Neoadjuvant Pazopanib~Pazopanib 800 mg PO once daily for 8 weeks~Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy"
259774|NCT01361113|O1|Outcome|1 Year Recurrence Free Survival|"Single Arm Neoadjuvant Pazopanib~Pazopanib 800 mg PO once daily for 8 weeks~Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy"
259775|NCT01361113|O1|Outcome|Single Arm Neoadjuvant Pazopanib|"Pazopanib 800 mg PO once daily for 8 weeks~Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy"
259776|NCT01361113|E1|Reported Event|Single Arm Neoadjuvant Pazopanib|"Pazopanib 800 mg PO once daily for 8 weeks~Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy"
259777|NCT01361048|B4|Baseline|Total|Total of all reporting groups
279180|NCT01303224|E4|Reported Event|Placebo|oral tablet, once daily
259779|NCT01361048|B2|Baseline|Neo Penotran Forte Twice a Day|neo penotran forte vaginal suppository twice a day for 7 days
259780|NCT01361048|B1|Baseline|Oral Metronidazole|control arm
259781|NCT01361048|P3|Participant Flow|Neo Penotran Forte Once a Day|neo penotran forte vaginal suppository once a day for 7 days
259782|NCT01361048|P2|Participant Flow|Neo Penotran Forte|neo penotran forte vaginal suppository twice a day for 7 days
259783|NCT01361048|P1|Participant Flow|Oral Metronidazole|control arm
259784|NCT01361048|O3|Outcome|Neo Penotran Forte Once a Day|"neo penotran forte vaginal suppository once a day for 7 days~neo penotran forte once a day: neo penotran forte intravaginally once a day for 7 days"
259785|NCT01361048|O2|Outcome|Neo Penotran Forte|"neo penotran forte vaginal suppository twice a day for 7 days~neo penotran forte: neo penotran forte intravaginal twice a day for 7 days"
259786|NCT01361048|O1|Outcome|Oral Metronidazole|"control arm~oral metronidazole: 2 gm oral once"
259787|NCT01361048|O3|Outcome|Neo Penotran Forte Once a Day|neo penotran forte vaginal suppository once a day for 7 days
259788|NCT01361048|O2|Outcome|Neo Penotran Forte|neo penotran forte vaginal suppository twice a day for 7 days
259789|NCT01361048|O1|Outcome|Oral Metronidazole 2 gm Stat Dose|control arm
259790|NCT01361048|E3|Reported Event|Neo Penotran Forte Once a Day|neo penotran forte vaginal suppository once a day for 7 days
259791|NCT01361048|E2|Reported Event|Neo Penotran Forte|neo penotran forte vaginal suppository twice a day for 7 days
259792|NCT01361048|E1|Reported Event|Oral Metronidazole|control arm
259793|NCT01361009|B1|Baseline|Pramipexole Goup|
259794|NCT01361009|P1|Participant Flow|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
259795|NCT01361009|O1|Outcome|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
259796|NCT01361009|O1|Outcome|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
259797|NCT01361009|O1|Outcome|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
259798|NCT01361009|O1|Outcome|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
259799|NCT01361009|E1|Reported Event|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
259800|NCT01360996|B4|Baseline|Total|Total of all reporting groups
259801|NCT01360996|B3|Baseline|3 mg DRSP/20 μg EE- Grade 1 Obese|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~BMI 30-34.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
259802|NCT01360996|B2|Baseline|3 mg DRSP/20 μg EE- Overweight|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~BMI 25-29.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
259803|NCT01360996|B1|Baseline|3 mg DRSP/20 μg EE--normal Weight|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~Normal weight -BMI 18-24.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
259804|NCT01360996|P3|Participant Flow|3 mg DRSP/20 μg EE- Grade 1 Obese|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~BMI 30-34.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
259805|NCT01360996|P2|Participant Flow|3 mg DRSP/20 μg EE- Overweight|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~BMI 25-29.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
259806|NCT01360996|P1|Participant Flow|3 mg DRSP/20 μg EE--normal Weight|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~Normal weight -BMI 18-24.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
259807|NCT01360996|O2|Outcome|Obese|"Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 30-34.9 kg/m2 (obese grade 10"
259808|NCT01360996|O1|Outcome|Non-Obese|"There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese~Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 18-29.9 kg/m2"
259809|NCT01360996|O2|Outcome|Obese|"Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 30-34.9 kg/m2 (obese grade 10"
259810|NCT01360996|O1|Outcome|Non-Obese|"There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese~Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 18-29.9 kg/m2"
259811|NCT01360996|O2|Outcome|Obese|"Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 30-34.9 kg/m2 (obese grade 10"
259812|NCT01360996|O1|Outcome|Non-Obese|"There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese~Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 18-29.9 kg/m2"
259813|NCT01360996|O2|Outcome|Obese|"Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 30-34.9 kg/m2 (obese grade 10"
259814|NCT01360996|O1|Outcome|Non-Obese|"There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese~Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 18-29.9 kg/m2"
259815|NCT01360996|O2|Outcome|Obese|"Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 30-34.9 kg/m2 (obese grade 10"
260747|NCT01358175|B3|Baseline|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
259816|NCT01360996|O1|Outcome|Non-Obese|"There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese~Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 18-29.9 kg/m2"
259817|NCT01360996|O2|Outcome|Obese|"Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 30-34.9 kg/m2 (obese grade 10"
259818|NCT01360996|O1|Outcome|Non-Obese|"There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese~Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 18-29.9 kg/m2"
259819|NCT01360996|O2|Outcome|Obese|"Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 30-34.9 kg/m2 (obese grade 10"
259820|NCT01360996|O1|Outcome|Non-Obese|"There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese~Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 18-29.9 kg/m2"
259821|NCT01360996|E3|Reported Event|3 mg DRSP/20 μg EE- Grade 1 Obese|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~BMI 30-34.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
259822|NCT01360996|E2|Reported Event|3 mg DRSP/20 μg EE- Overweight|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~BMI 25-29.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
259823|NCT01360996|E1|Reported Event|3 mg DRSP/20 μg EE--normal Weight|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~Normal weight -BMI 18-24.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
259824|NCT01360840|B4|Baseline|Total|Total of all reporting groups
259825|NCT01360840|B3|Baseline|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259826|NCT01360840|B2|Baseline|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259827|NCT01360840|B1|Baseline|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259828|NCT01360840|P3|Participant Flow|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259829|NCT01360840|P2|Participant Flow|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259830|NCT01360840|P1|Participant Flow|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the standard of care (SoC) consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259831|NCT01360840|O2|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259832|NCT01360840|O1|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259885|NCT01360645|P1|Participant Flow|Single-blind Placebo + ADT|In Phase A, participants were administered placebo as an adjunctive therapy to an open label ADT for 8 weeks
259886|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259833|NCT01360840|O2|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259834|NCT01360840|O1|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259835|NCT01360840|O2|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259836|NCT01360840|O1|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259837|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259838|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259839|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259840|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259841|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259842|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259843|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259844|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259887|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
261091|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
259845|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259846|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259847|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259848|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259849|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259850|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259851|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259852|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259853|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259854|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259855|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259856|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259888|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259986|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
259857|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259858|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259859|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259860|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259861|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259862|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259863|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259864|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259865|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259866|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259867|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259868|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259889|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259987|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
259869|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259870|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259871|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259872|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259873|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259874|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259875|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259876|NCT01360840|E3|Reported Event|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259877|NCT01360840|E2|Reported Event|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 milligram (mg) (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259878|NCT01360840|E1|Reported Event|Placebo + SoC|Subjects were administered with placebo 0.9 percent (%) sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
259879|NCT01360645|B3|Baseline|Total|Total of all reporting groups
259880|NCT01360645|B2|Baseline|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259881|NCT01360645|B1|Baseline|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259882|NCT01360645|P4|Participant Flow|Phase A+ Placebo + ADT|Participants who did not meet criteria for randomization and a follow-up of 30 (+2) days after the last dose of study medication were in Phase A+
259883|NCT01360645|P3|Participant Flow|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259884|NCT01360645|P2|Participant Flow|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
260789|NCT01357980|P4|Participant Flow|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
259890|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259891|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259892|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259893|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259894|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259895|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259896|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259897|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259898|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259899|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259900|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259901|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259902|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259903|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259904|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259905|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259906|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259907|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259908|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259909|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259910|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259911|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259912|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259913|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259914|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259915|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259916|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259917|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259918|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259919|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259920|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259921|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259922|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259923|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259924|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259925|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259926|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259927|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259928|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259929|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259930|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259931|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259932|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259933|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259934|NCT01360645|E2|Reported Event|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259935|NCT01360645|E1|Reported Event|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
259936|NCT01360632|B4|Baseline|Total|Total of all reporting groups
259937|NCT01360632|B3|Baseline|Placebo + ADT|Participants were administered placebo as an adjunctive therapy to an open label ADT.
259938|NCT01360632|B2|Baseline|Brexpiprazole (3mg + ADT)|Participants were administered brexpiprazole of 3mg as an adjunctive therapy to an assigned open-label ADT.
259939|NCT01360632|B1|Baseline|Brexpiprazole (1mg + ADT)|Participants were administered brexpiprazole of 1mg as an adjunctive therapy to an assigned open-label ADT.
259940|NCT01360632|P5|Participant Flow|Phase A+ Placebo + ADT|Participants who did not meet criteria for randomization and a follow-up of 30 (+2) days after the last dose of study medication were in Phase A+
259941|NCT01360632|P4|Participant Flow|Double-blind Placebo + ADT|In phase B, participants were administered placebo as an adjunctive therapy to an open label ADT for 6 weeks.
259942|NCT01360632|P3|Participant Flow|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole of 3mg as an adjunctive therapy to an assigned open-label ADT.
259943|NCT01360632|P2|Participant Flow|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole of [1mg (milligram)] as an adjunctive therapy to an assigned open-label ADT (anti-depressant therapy).
259944|NCT01360632|P1|Participant Flow|Single-blind Placebo + ADT|In Phase A, participants were administered placebo as an adjunctive therapy to an open label ADT for 8 weeks.
259945|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
259946|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
259947|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
259948|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
259949|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
259950|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
259951|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
259952|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
259953|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
259954|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
259955|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
259956|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
259957|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
259958|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
259959|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
259960|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
259961|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
259962|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
259963|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
259964|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
259965|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
259966|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
259967|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
259968|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
259969|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
259970|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
259971|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
259972|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
259973|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
259974|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
259975|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
259976|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
259977|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
259978|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
259979|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
259980|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
259981|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
259982|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
259983|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
259984|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
259985|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
261092|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
259988|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
259989|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
259990|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
259991|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
259992|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
259993|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
259994|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
259995|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
259996|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
259997|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
259998|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
259999|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
260000|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
260001|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
260002|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
260003|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
260004|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
260005|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
260006|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
260007|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
260008|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
260009|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
260010|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
260011|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
260012|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
260013|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
260014|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
260015|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
260016|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
260017|NCT01360632|E3|Reported Event|Placebo + ADT|Participants were administered placebo as an adjunctive therapy to an open label ADT.
260018|NCT01360632|E2|Reported Event|Brexpiprazole (3mg + ADT)|Participants were administered brexpiprazole of 3mg as an adjunctive therapy to an assigned open-label ADT.
260019|NCT01360632|E1|Reported Event|Brexpiprazole (1mg + ADT)|Participants were administered brexpiprazole of 1mg as an adjunctive therapy to an assigned open-label ADT.
260020|NCT01360554|B3|Baseline|Total|Total of all reporting groups
260021|NCT01360554|B2|Baseline|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260022|NCT01360554|B1|Baseline|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260023|NCT01360554|P2|Participant Flow|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260024|NCT01360554|P1|Participant Flow|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260102|NCT01359943|B2|Baseline|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
261093|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
260025|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260026|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260027|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260028|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260029|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260030|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260031|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260032|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260033|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260034|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260035|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260036|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260037|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260038|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260039|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260040|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260041|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260042|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260043|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260044|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260045|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260046|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260047|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260048|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260049|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260050|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260051|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260052|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260053|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260054|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260055|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260056|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260057|NCT01360554|E2|Reported Event|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260058|NCT01360554|E1|Reported Event|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
260059|NCT01360450|B3|Baseline|Total|Total of all reporting groups
260060|NCT01360450|B2|Baseline|Control|"Infants will receive place (saline) (if receiving it IV) or orally (sterile water) if receiving it orally~saline: Infants randomized to placebo will be administered IV saline or oral sterile water in the same volume as study drug. The placebo will be give every 4 hrs as outlined in the algorithm for the study."
260061|NCT01360450|B1|Baseline|Treatment|"Infants will receive intravenous or oral clonidine(Duraclon) for the treatment of pain and sedation~Clonidine HCL: At day 5 on opioid and/or benzodiazepine (BZD), the infant will be randomized to receive either placebo (normal saline) or clonidine 1μg/kg/q 4 hrs to a maximum dose of 2μg/kg/q 4. Weaning from the study drug: When the opioid is no longer required, 24 hrs later the study drug (placebo or study drug) will be reduced by 50% and then discontinued 24 hours later provided that the Modified Finnegan scores remain between < 9."
260062|NCT01360450|P2|Participant Flow|Control|"Infants will receive place (saline) (if receiving it IV) or orally (sterile water) if receiving it orally~saline: Infants randomized to placebo will be administered IV saline or oral sterile water in the same volume as study drug. The placebo will be give every 4 hrs as outlined in the algorithm for the study."
260137|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
280595|NCT01299454|B5|Baseline|Total|Total of all reporting groups
260063|NCT01360450|P1|Participant Flow|Treatment|"Infants will receive intravenous or oral clonidine(Duraclon) for the treatment of pain and sedation~Clonidine Hydrochloride: At day 5 on opioid and/or benzodiazepine (BZD), the infant will be randomized to receive either placebo (normal saline) or clonidine 1μg/kg/q 4 hrs to a maximum dose of 2μg/kg/q 4. Weaning from the study drug: When the opioid is no longer required, 24 hrs later the study drug (placebo or study drug) will be reduced by 50% and then discontinued 24 hours later provided that the Modified Finnegan scores remain between < 9."
260064|NCT01360450|O2|Outcome|Control|"Infants will receive place (saline) (if receiving it IV) or orally (sterile water) if receiving it orally~saline: Infants randomized to placebo will be administered IV saline or oral sterile water in the same volume as study drug. The placebo will be give every 4 hrs as outlined in the algorithm for the study."
260065|NCT01360450|O1|Outcome|Treatment|"Infants will receive intravenous or oral clonidine(Duraclon) for the treatment of pain and sedation~Clonidine Hydrochloride: At day 5 on opioid and/or benzodiazepine (BZD), the infant will be randomized to receive either placebo (normal saline) or clonidine 1μg/kg/q 4 hrs to a maximum dose of 2μg/kg/q 4. Weaning from the study drug: When the opioid is no longer required, 24 hrs later the study drug (placebo or study drug) will be reduced by 50% and then discontinued 24 hours later provided that the Modified Finnegan scores remain between < 9."
260066|NCT01360450|O2|Outcome|Control|"Infants will receive place (saline) (if receiving it IV) or orally (sterile water) if receiving it orally~saline: Infants randomized to placebo will be administered IV saline or oral sterile water in the same volume as study drug. The placebo will be give every 4 hrs as outlined in the algorithm for the study."
260067|NCT01360450|O1|Outcome|Treatment|"Infants will receive intravenous or oral clonidine(Duraclon) for the treatment of pain and sedation~Clonidine Hydrochloride: At day 5 on opioid and/or benzodiazepine (BZD), the infant will be randomized to receive either placebo (normal saline) or clonidine 1μg/kg/q 4 hrs to a maximum dose of 2μg/kg/q 4. Weaning from the study drug: When the opioid is no longer required, 24 hrs later the study drug (placebo or study drug) will be reduced by 50% and then discontinued 24 hours later provided that the Modified Finnegan scores remain between < 9."
260068|NCT01360450|O2|Outcome|Control|"Infants will receive place (saline) (if receiving it IV) or orally (sterile water) if receiving it orally~saline: Infants randomized to placebo will be administered IV saline or oral sterile water in the same volume as study drug. The placebo will be give every 4 hrs as outlined in the algorithm for the study."
260069|NCT01360450|O1|Outcome|Treatment|"Infants will receive intravenous or oral clonidine(Duraclon) for the treatment of pain and sedation~Clonidine HCL: At day 5 on opioid and/or benzodiazepine (BZD), the infant will be randomized to receive either placebo (normal saline) or clonidine 1μg/kg/q 4 hrs to a maximum dose of 2μg/kg/q 4. Weaning from the study drug: When the opioid is no longer required, 24 hrs later the study drug (placebo or study drug) will be reduced by 50% and then discontinued 24 hours later provided that the Modified Finnegan scores remain between < 9."
260070|NCT01360450|E2|Reported Event|Control|"Infants will receive place (saline) (if receiving it IV) or orally (sterile water) if receiving it orally~saline: Infants randomized to placebo will be administered IV saline or oral sterile water in the same volume as study drug. The placebo will be give every 4 hrs as outlined in the algorithm for the study."
260071|NCT01360450|E1|Reported Event|Treatment|"Infants will receive intravenous or oral clonidine(Duraclon) for the treatment of pain and sedation~Clonidine HCL: At day 5 on opioid and/or benzodiazepine (BZD), the infant will be randomized to receive either placebo (normal saline) or clonidine 1μg/kg/q 4 hrs to a maximum dose of 2μg/kg/q 4. Weaning from the study drug: When the opioid is no longer required, 24 hrs later the study drug (placebo or study drug) will be reduced by 50% and then discontinued 24 hours later provided that the Modified Finnegan scores remain between < 9."
260072|NCT01360021|B4|Baseline|Total|Total of all reporting groups
260073|NCT01360021|B3|Baseline|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
260074|NCT01360021|B2|Baseline|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
260075|NCT01360021|B1|Baseline|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
260076|NCT01360021|P3|Participant Flow|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
260077|NCT01360021|P2|Participant Flow|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
260078|NCT01360021|P1|Participant Flow|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
260079|NCT01360021|O3|Outcome|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
260080|NCT01360021|O2|Outcome|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
260081|NCT01360021|O1|Outcome|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
260082|NCT01360021|O3|Outcome|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
260083|NCT01360021|O2|Outcome|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
260084|NCT01360021|O1|Outcome|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
260085|NCT01360021|O3|Outcome|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
260086|NCT01360021|O2|Outcome|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
260087|NCT01360021|O1|Outcome|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
260088|NCT01360021|O3|Outcome|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
260089|NCT01360021|O2|Outcome|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
260090|NCT01360021|O1|Outcome|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
260091|NCT01360021|O3|Outcome|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
260092|NCT01360021|O2|Outcome|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
260093|NCT01360021|O1|Outcome|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
260094|NCT01360021|O3|Outcome|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
260095|NCT01360021|O2|Outcome|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
260096|NCT01360021|O1|Outcome|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
260097|NCT01360021|E3|Reported Event|Symbicort pMDI|
260098|NCT01360021|E2|Reported Event|Symbicort BA MDI|
260099|NCT01360021|E1|Reported Event|Budesonide|
260100|NCT01359943|B4|Baseline|Total|Total of all reporting groups
260101|NCT01359943|B3|Baseline|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
261094|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
260103|NCT01359943|B1|Baseline|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260104|NCT01359943|P3|Participant Flow|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
260105|NCT01359943|P2|Participant Flow|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260106|NCT01359943|P1|Participant Flow|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260107|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
260108|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260109|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260110|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
260111|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260112|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260113|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
260114|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260115|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260116|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
260117|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260118|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260119|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
260120|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260121|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260122|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
260123|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260124|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260125|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
260126|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260127|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260128|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
260129|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260130|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260131|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
260132|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260133|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260134|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
260135|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260136|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
261095|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
260138|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260139|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260140|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
260141|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260142|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260143|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
260144|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260145|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260146|NCT01359943|E5|Reported Event|AIN457 Pooled Treatment Groups - Follow-up Period|Follow-up period: week 52 through week 60 - AIN457 150 mg sc open label
260147|NCT01359943|E4|Reported Event|AIN457 Pooled Treatment Groups - Open Label Period|Week 16 through week 52: AIN457 150 mg s.c. open label
260148|NCT01359943|E3|Reported Event|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
260149|NCT01359943|E2|Reported Event|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260150|NCT01359943|E1|Reported Event|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
260151|NCT01359904|B3|Baseline|Total|Total of all reporting groups
260152|NCT01359904|B2|Baseline|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
260153|NCT01359904|B1|Baseline|High Dialysate Bath|additive is put in the dialysate to increase the concentration of glucose to 10mmol/l
260154|NCT01359904|P2|Participant Flow|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
260155|NCT01359904|P1|Participant Flow|High Dialysate Bath|additive is put in the dialysate to increase the concentration of glucose to 10mmol/l
260156|NCT01359904|O2|Outcome|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
260157|NCT01359904|O1|Outcome|High Dialysate Bath|"additive is put in the dialysate to increase the concentration of glucose to 10mmol/l~High Dialysate bath: The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution."
260158|NCT01359904|O2|Outcome|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
260159|NCT01359904|O1|Outcome|High Dialysate Bath|"additive is put in the dialysate to increase the concentration of glucose to 10mmol/l~High Dialysate bath: The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution."
260160|NCT01359904|O2|Outcome|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
260161|NCT01359904|O1|Outcome|High Dialysate Bath|"additive is put in the dialysate to increase the concentration of glucose to 10mmol/l~High Dialysate bath: The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution."
260162|NCT01359904|O2|Outcome|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
260163|NCT01359904|O1|Outcome|High Dialysate Bath|"additive is put in the dialysate to increase the concentration of glucose to 10mmol/l~High Dialysate bath: The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution."
260164|NCT01359904|E2|Reported Event|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
260165|NCT01359904|E1|Reported Event|High Dialysate Bath|"additive is put in the dialysate to increase the concentration of glucose to 10mmol/l~High Dialysate bath: The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution."
260166|NCT01359748|B5|Baseline|Total|Total of all reporting groups
260167|NCT01359748|B4|Baseline|Wrist Size >=17.75|Subjects, males or females, with wrist size specified.
260168|NCT01359748|B3|Baseline|Wrist Size >=16.5 Cm|Subjects, males or females, with wrist size specified.
260169|NCT01359748|B2|Baseline|Wrist Size<=16.40 Cm|Subjects, males or females, with wrist size specified.
260170|NCT01359748|B1|Baseline|Wrist Size <=14.25Cm|Subjects, males or females, with wrist size specified.
260171|NCT01359748|P4|Participant Flow|Subjects With Wrist Size >=17.75Cm|"Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference.~The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm."
260172|NCT01359748|P3|Participant Flow|Subjects With Wrist Size >=16.50Cm|"Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference.~The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm."
260173|NCT01359748|P2|Participant Flow|Subjects With Wrist Size <=14.25Cm|"Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference.~The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm."
260250|NCT01359644|E9|Reported Event|Treatment I: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
260174|NCT01359748|P1|Participant Flow|Subjects With Wrist Size >=14.26Cm|"Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference.~The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm."
260175|NCT01359748|O1|Outcome|Subjects|Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009
260176|NCT01359748|O1|Outcome|Subjects|Subjects who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009
260177|NCT01359748|E4|Reported Event|Wrist Size >=17.75 Cm|Subjects with wrist size equal or higher than 17.75 Cm
260178|NCT01359748|E3|Reported Event|Wrist Size >=16.5 Cm|Subjects with wrist size equal or higher than 16.5 Cm
260179|NCT01359748|E2|Reported Event|Wrist Size <=16.4Cm|Subjects with wrist size equal or less than 16.40 Cm
260180|NCT01359748|E1|Reported Event|Wrist Size <=14.25 Cm|Subjects with wrist size equal or less than 14.25 Cm
260181|NCT01359735|B3|Baseline|Total|Total of all reporting groups
260182|NCT01359735|B2|Baseline|Bacitracin Ointment|"bacitracin antibiotic ointment~Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed)."
260183|NCT01359735|B1|Baseline|HP802-247|"allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly~HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed"
260184|NCT01359735|P2|Participant Flow|Bacitracin Ointment|"bacitracin antibiotic ointment~Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed)."
260185|NCT01359735|P1|Participant Flow|HP802-247|"allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly~HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed"
260186|NCT01359735|O2|Outcome|Bacitracin Ointment|"bacitracin antibiotic ointment~Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed)."
260187|NCT01359735|O1|Outcome|HP802-247|"allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly~HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed"
260188|NCT01359735|O2|Outcome|Bacitracin Ointment|"bacitracin antibiotic ointment~Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed)."
260189|NCT01359735|O1|Outcome|HP802-247|"allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly~HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed"
260190|NCT01359735|O2|Outcome|Bacitracin Ointment|"bacitracin antibiotic ointment~Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed)."
260191|NCT01359735|O1|Outcome|HP802-247|"allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly~HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed"
260192|NCT01359735|O2|Outcome|Bacitracin Ointment|"bacitracin antibiotic ointment~Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed)."
260193|NCT01359735|O1|Outcome|HP802-247|"allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly~HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed"
260194|NCT01359735|O2|Outcome|Bacitracin Ointment|"bacitracin antibiotic ointment~Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed)."
260195|NCT01359735|O1|Outcome|HP802-247|"allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly~HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed"
260196|NCT01359735|E2|Reported Event|Bacitracin Ointment|"bacitracin antibiotic ointment~Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed)."
260197|NCT01359735|E1|Reported Event|HP802-247|"allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly~HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed"
260198|NCT01359644|B11|Baseline|Total|Total of all reporting groups
260199|NCT01359644|B10|Baseline|Treatment J: Sofosbuvir +Daclatasvir +Ribavirin|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg once daily, daclatasvir, 60 mg, once daily for 24 weeks and ribavarin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg) and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥75 kg) for 24 weeks.
260200|NCT01359644|B9|Baseline|Treatment I: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg once daily and daclatasvir, 60 mg, once daily for 24 weeks.
260201|NCT01359644|B8|Baseline|Treatment H: Sofosbuvir +Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥ 75 kg) for 12 weeks.
260202|NCT01359644|B7|Baseline|Treatment G: Sofosbuvir + Daclatasvir|Participants with genotype1 a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks..
260203|NCT01359644|B6|Baseline|Treatment F: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.
260278|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
260204|NCT01359644|B5|Baseline|Treatment E: Sofosbuvir +Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
260205|NCT01359644|B4|Baseline|Treatment D: Sofosbuvir + Daclatasvir|Participants with genotype-2 or -3 received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks..
260206|NCT01359644|B3|Baseline|Treatment C: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
260207|NCT01359644|B2|Baseline|Treatment: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
260208|NCT01359644|B1|Baseline|Treatment A: Sofosbuvir + Daclatasvir|Participants with hepatitis C virus genotype 1a or 1b received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
260209|NCT01359644|P10|Participant Flow|Treatment J: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 24 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥75 kg) for 24 weeks.
260210|NCT01359644|P9|Participant Flow|Treatment I: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
260211|NCT01359644|P8|Participant Flow|Treatment H : Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥ 75 kg) for 12 weeks.
260212|NCT01359644|P7|Participant Flow|Treatment G: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.
260213|NCT01359644|P6|Participant Flow|Treatment F: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.
260214|NCT01359644|P5|Participant Flow|Treatment E: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
260215|NCT01359644|P4|Participant Flow|Treatment D: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
260216|NCT01359644|P3|Participant Flow|Treatment C: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
260217|NCT01359644|P2|Participant Flow|Treatment B: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
260218|NCT01359644|P1|Participant Flow|Treatment A: Sofosbuvir + Daclatasvir|Participants with hepatitis C virus (HCV) genotypes 1a or 1b received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
260219|NCT01359644|O4|Outcome|Daclatasvir + Sofosbuvir Without Ribivirin (24 Weeks)|Participants received sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 12 weeks.
260220|NCT01359644|O3|Outcome|Daclatasvir + Sofosbuvir Without Ribivirin (12 Weeks)|Participants received sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 12 weeks.
260221|NCT01359644|O2|Outcome|Daclatasvir + Sofosbuvir With Ribivirin (24 Weeks)|Participants received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 24 weeks.
260222|NCT01359644|O1|Outcome|Daclatasvir + Sofosbuvir + Ribivirin (12 Weeks)|Participants received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 12 weeks.
260223|NCT01359644|O4|Outcome|Daclatasvir + Sofosbuvir Without Ribivirin (24 Weeks)|Participants received sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 12 weeks.
260224|NCT01359644|O3|Outcome|Daclatasvir + Sofosbuvir Without Ribivirin (12 Weeks)|Participants received sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 12 weeks.
260225|NCT01359644|O2|Outcome|Daclatasvir + Sofosbuvir With Ribivirin (24 Weeks)|Participants received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 24 weeks.
260226|NCT01359644|O1|Outcome|Daclatasvir + Sofosbuvir + Ribivirin (12 Weeks)|Participants received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 12 weeks.
260227|NCT01359644|O10|Outcome|Treatment J: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets at AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
260228|NCT01359644|O9|Outcome|Treatment I: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure were administered with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.
260229|NCT01359644|O8|Outcome|Treatment H: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received with sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 12 weeks.
260230|NCT01359644|O7|Outcome|Treatment G: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.
260231|NCT01359644|O6|Outcome|Treatment F: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.
260232|NCT01359644|O5|Outcome|Treatment E: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
260233|NCT01359644|O4|Outcome|Treatment D: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.
260234|NCT01359644|O3|Outcome|Treatment C: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
260235|NCT01359644|O2|Outcome|Treatment B: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
260236|NCT01359644|O1|Outcome|Treatment A: Sofosbuvir + Daclatasvir|Participants with hepatitis C virus genotypes 1a or 1b received sofosbuvir, 400 mg, once daily) for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
260237|NCT01359644|O3|Outcome|Telaprevir or Boceprevir Failures With Genotype 1|Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
260238|NCT01359644|O2|Outcome|Treatment-naive Participants With Genotype 2 or 3|Participants with genotype 2 or 3 and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.
260239|NCT01359644|O1|Outcome|Treatment-naive Participants With Genotype 1|Participants with genotype 1a or 1b and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg, ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
260240|NCT01359644|O3|Outcome|Telaprevir or Boceprevir Failures With Genotype 1|Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
260241|NCT01359644|O2|Outcome|Treatment-naive Participants With Genotype 2 or 3|Participants with genotype 2 or 3 and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.
260242|NCT01359644|O1|Outcome|Treatment-naive Participants With Genotype 1|Participants with genotype 1a or 1b and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg, ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
260243|NCT01359644|O3|Outcome|Telaprevir/Boceprevir Failures With Genotype 1|Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 24 weeks.
260244|NCT01359644|O2|Outcome|Treatment-naive Participants With Genotype 2 or 3|Participants with genotype 2 or 3 and no previous exposure to an interferon formulation or ribavirin or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.
260245|NCT01359644|O1|Outcome|Treatment-naive Participants With Genotype 1|Participants with genotype 1a or 1b and no previous exposure to an interferon formulation or ribavirin or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir 400 mg tablets + daclatasvir 60 mg tablets ± ribavirin (a total daily dose of 1000 mg/1200mg) tablets once daily for 12 or 24 weeks.
260246|NCT01359644|O3|Outcome|Telaprevir or Boceprevir Failures With Genotype 1|Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 24 weeks.
260247|NCT01359644|O2|Outcome|Treatment-naive Participants With Genotype 2 or 3|Participants with genotype 2 or 3 and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.
260248|NCT01359644|O1|Outcome|Treatment-naive Participants With Genotype 1|Participants with genotype 1a or 1b and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg, ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
260249|NCT01359644|E10|Reported Event|Treatment J: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 24 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥75 kg) for 24 weeks.
261096|NCT01357239|O3|Outcome|Placebo|2 capsules of placebo per intake
260251|NCT01359644|E8|Reported Event|Treatment H : Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥ 75 kg) for 12 weeks.
260252|NCT01359644|E7|Reported Event|Treatment G: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.
260253|NCT01359644|E6|Reported Event|Treatment F: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks
260254|NCT01359644|E5|Reported Event|Treatment E: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
260255|NCT01359644|E4|Reported Event|Treatment D: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
260256|NCT01359644|E3|Reported Event|Treatment C: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
260257|NCT01359644|E2|Reported Event|Treatment B: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks
260258|NCT01359644|E1|Reported Event|Treatment A: Sofosbuvir + Daclatasvir|Participants with hepatitis C virus (HCV) genotypes 1a or 1b received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
260259|NCT01359449|B3|Baseline|Total|Total of all reporting groups
260260|NCT01359449|B2|Baseline|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
260261|NCT01359449|B1|Baseline|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
260262|NCT01359449|P2|Participant Flow|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
260263|NCT01359449|P1|Participant Flow|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
260264|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
260265|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
260266|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
260267|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
260268|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
260269|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
260270|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
260271|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
260272|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
260273|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
260274|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
260275|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
260276|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
260277|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
261097|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
260279|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
260280|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
260281|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
260282|NCT01359449|E2|Reported Event|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
260283|NCT01359449|E1|Reported Event|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
260284|NCT01359410|B3|Baseline|Total|Total of all reporting groups
260285|NCT01359410|B2|Baseline|Stapled Transection Without Mesh Reinforcement|
260286|NCT01359410|B1|Baseline|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
260287|NCT01359410|P2|Participant Flow|Stapled Transection Without Mesh Reinforcement|
260288|NCT01359410|P1|Participant Flow|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
260289|NCT01359410|O2|Outcome|Stapled Transection Without Mesh Reinforcement|
260290|NCT01359410|O1|Outcome|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
260291|NCT01359410|O2|Outcome|Stapled Transection Without Mesh Reinforcement|
260292|NCT01359410|O1|Outcome|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
260293|NCT01359410|O2|Outcome|Stapled Transection Without Mesh Reinforcement|
260294|NCT01359410|O1|Outcome|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
260295|NCT01359410|O2|Outcome|Stapled Transection Without Mesh Reinforcement|
260296|NCT01359410|O1|Outcome|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
260297|NCT01359410|O2|Outcome|Stapled Transection Without Mesh Reinforcement|
260298|NCT01359410|O1|Outcome|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
260299|NCT01359410|E2|Reported Event|Stapled Transection Without Mesh Reinforcement|
260300|NCT01359410|E1|Reported Event|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
260301|NCT01359371|B1|Baseline|Volunteer Telephone Cessation Counseling|The cohort is discharged veteran smokers who received the standard-of-care Tobacco Tactics intervention while in the hospital.
260302|NCT01359371|P1|Participant Flow|Volunteer Telephone Cessation Counseling|The cohort is discharged veteran smokers who received the standard-of-care Tobacco Tactics intervention while in the hospital.
260303|NCT01359371|O2|Outcome|Number of Times Reached for Peer Telephone Counseling:3-4times|The cohort is discharged veteran smokers who received the standard-of-care Tobacco Tactics intervention while in the hospital. This group was reached 3-4 times for peer telephone counseling.
260304|NCT01359371|O1|Outcome|Number of Times Reached for Peer Telephone Counseling:0-2times|The cohort is discharged veteran smokers who received the standard-of-care Tobacco Tactics intervention while in the hospital. This group was reached 0-2 times for peer telephone counseling.
260305|NCT01359371|E1|Reported Event|Volunteer Telephone Cessation Counseling|The cohort is discharged veteran smokers who received the standard-of-care Tobacco Tactics intervention while in the hospital.
260306|NCT01359254|B3|Baseline|Total|Total of all reporting groups
260307|NCT01359254|B2|Baseline|Fludarabine, Busulfan, ATG, and TBI|"Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.~Busulfan: Busulfan is given daily for 4 days.~Total Body Irradiation (TBI): TBI is given twice on the last day."
260308|NCT01359254|B1|Baseline|Fludarabine, Melphalan, and ATG|"Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)~Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days."
260309|NCT01359254|P2|Participant Flow|Fludarabine, Busulfan, ATG, and TBI|"Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.~Busulfan: Busulfan is given daily for 4 days.~Total Body Irradiation (TBI): TBI is given twice on the last day."
260310|NCT01359254|P1|Participant Flow|Fludarabine, Melphalan, and ATG|"Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)~Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days."
260311|NCT01359254|O2|Outcome|Fludarabine, Busulfan, ATG, and TBI|"Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.~Busulfan: Busulfan is given daily for 4 days.~Total Body Irradiation (TBI): TBI is given twice on the last day."
260312|NCT01359254|O1|Outcome|Fludarabine, Melphalan, and ATG|"Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)~Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days."
260537|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
260313|NCT01359254|O2|Outcome|Fludarabine, Busulfan, ATG, and TBI|"Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.~Busulfan: Busulfan is given daily for 4 days.~Total Body Irradiation (TBI): TBI is given twice on the last day."
260314|NCT01359254|O1|Outcome|Fludarabine, Melphalan, and ATG|"Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)~Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days."
260315|NCT01359254|E2|Reported Event|Fludarabine, Busulfan, ATG, and TBI|"Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.~Busulfan: Busulfan is given daily for 4 days.~Total Body Irradiation (TBI): TBI is given twice on the last day."
260316|NCT01359254|E1|Reported Event|Fludarabine, Melphalan, and ATG|"Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)~Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days."
260317|NCT01359150|B3|Baseline|Total|Total of all reporting groups
260318|NCT01359150|B2|Baseline|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
260319|NCT01359150|B1|Baseline|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
260320|NCT01359150|P2|Participant Flow|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
260321|NCT01359150|P1|Participant Flow|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
260322|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
260323|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
260324|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
260325|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
260326|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
260327|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
260328|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
260329|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
260330|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
260331|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
260332|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
260333|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
260698|NCT01358526|O2|Outcome|Placebo Group|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
260334|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
260335|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
260336|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
260337|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
260338|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
260339|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
260340|NCT01359150|E2|Reported Event|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
260341|NCT01359150|E1|Reported Event|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
260342|NCT01359111|B1|Baseline|Intradermal Adapter|Saline injection with intradermal adapter
260343|NCT01359111|P1|Participant Flow|Intradermal Adapter|Saline injection with intradermal adapter
260344|NCT01359111|O2|Outcome|Bevel Down|Saline injection with intradermal adapter used with needle bevel oriented down relative to the surface of the skin
260345|NCT01359111|O1|Outcome|Bevel Up|Saline injection with intradermal adapter used with needle bevel oriented up relative to the surface of the skin
260346|NCT01359111|O1|Outcome|Intradermal Adapter|Saline injection with intradermal adapter
260347|NCT01359111|O1|Outcome|Intradermal Adapter|Saline injection with intradermal adapter
260348|NCT01359111|E1|Reported Event|Intradermal Adapter|Saline injection with intradermal adapter
260349|NCT01359007|B1|Baseline|FOLFIRINOX|"Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded.~Irinotecan, Oxaliplatin, Leucovorin, 5-FU: 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently"
260350|NCT01359007|P1|Participant Flow|FOLFIRINOX|"Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded.~Irinotecan, Oxaliplatin, Leucovorin, 5-FU: 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently"
260351|NCT01359007|O1|Outcome|FOLFIRINOX|"Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded.~Irinotecan, Oxaliplatin, Leucovorin, 5-FU: 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently"
260352|NCT01359007|O1|Outcome|FOLFIRINOX|"Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded.~Irinotecan, Oxaliplatin, Leucovorin, 5-FU: 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently"
260435|NCT01358864|P4|Participant Flow|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
260451|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
260353|NCT01359007|O1|Outcome|FOLFIRINOX|"Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded.~Irinotecan, Oxaliplatin, Leucovorin, 5-FU: 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently"
260354|NCT01359007|O1|Outcome|FOLFIRINOX|"Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded.~Irinotecan, Oxaliplatin, Leucovorin, 5-FU: 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently"
260355|NCT01359007|O1|Outcome|5-FU, Leucovorin, Oxaliplatin, Irinotecan|As per above
260356|NCT01359007|E1|Reported Event|FOLFIRINOX|"Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded.~Irinotecan, Oxaliplatin, Leucovorin, 5-FU: 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently"
260357|NCT01358877|B3|Baseline|Total|Total of all reporting groups
260358|NCT01358877|B2|Baseline|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260359|NCT01358877|B1|Baseline|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260360|NCT01358877|P2|Participant Flow|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 milligrams per kilogram [mg/kg] loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 milligrams per square meter (mg/m^2) + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 milligrams [mg]).
260361|NCT01358877|P1|Participant Flow|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) intravenously (IV) every 3 weeks (Q3W) for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 once weekly (QW); 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260362|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
261098|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
260363|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260364|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260365|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260366|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260367|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260368|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260369|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260436|NCT01358864|P3|Participant Flow|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
260472|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260370|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260371|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260372|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260373|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260374|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260375|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260376|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260437|NCT01358864|P2|Participant Flow|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir (BI 201335) 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
260438|NCT01358864|P1|Participant Flow|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
260377|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260378|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260379|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260380|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260381|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260382|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260383|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260439|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260440|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
261099|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
260384|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260385|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260386|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260387|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260388|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260389|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260390|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260441|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260442|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260790|NCT01357980|P3|Participant Flow|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
260391|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260392|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260393|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260394|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260395|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260396|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260397|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260443|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
260444|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
261100|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
260398|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260399|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260400|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260401|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260402|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260403|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260404|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260445|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
260446|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
281736|NCT01296646|O1|Outcome|Placebo|Placebo taken once daily.
260405|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260406|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260407|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260408|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260409|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260410|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260411|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260447|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260448|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260791|NCT01357980|P2|Participant Flow|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
260412|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260413|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260414|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260415|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260416|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260417|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260418|NCT01358877|O2|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260449|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260450|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260792|NCT01357980|P1|Participant Flow|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
260419|NCT01358877|O1|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260420|NCT01358877|E2|Reported Event|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
260421|NCT01358877|E1|Reported Event|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
260422|NCT01358864|B9|Baseline|Total|Total of all reporting groups
260423|NCT01358864|B8|Baseline|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260424|NCT01358864|B7|Baseline|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260425|NCT01358864|B6|Baseline|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260426|NCT01358864|B5|Baseline|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260427|NCT01358864|B4|Baseline|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
260428|NCT01358864|B3|Baseline|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
260429|NCT01358864|B2|Baseline|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
260430|NCT01358864|B1|Baseline|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
260431|NCT01358864|P8|Participant Flow|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260432|NCT01358864|P7|Participant Flow|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260433|NCT01358864|P6|Participant Flow|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260434|NCT01358864|P5|Participant Flow|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260793|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
260452|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
260453|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
260454|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
260455|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260456|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260457|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260458|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260459|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
260460|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
260461|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
260462|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
260463|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260464|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260465|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260466|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260467|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
260468|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
260469|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
260470|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
260471|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260794|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
260473|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260474|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260475|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
260476|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
260477|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
260478|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
260479|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260480|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260481|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260482|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260483|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
260484|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
260485|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
260486|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
260487|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260488|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260489|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260490|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260491|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
260492|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
260536|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
260493|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
260494|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
260495|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260496|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260497|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260498|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260499|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
260500|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
260501|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
260502|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
260503|NCT01358864|O5|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260504|NCT01358864|O4|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260505|NCT01358864|O3|Outcome|Relapser & Partial: Faldaprevir 24 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
260506|NCT01358864|O2|Outcome|Relapser & Partial: Faldaprevir 12 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
260507|NCT01358864|O1|Outcome|Relapser & Partial: Placebo|Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
260508|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260509|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260510|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260511|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260512|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
282293|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
260513|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
260514|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
260515|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
260516|NCT01358864|O5|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260517|NCT01358864|O4|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260518|NCT01358864|O3|Outcome|Relapser & Partial: Faldaprevir 24 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
260519|NCT01358864|O2|Outcome|Relapser & Partial: Faldaprevir 12 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
260520|NCT01358864|O1|Outcome|Relapser & Partial: Placebo|Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
260521|NCT01358864|E5|Reported Event|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260522|NCT01358864|E4|Reported Event|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
260523|NCT01358864|E3|Reported Event|Relapser & Partial: Faldaprevir 24 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
260524|NCT01358864|E2|Reported Event|Relapser & Partial: Faldaprevir 12 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
260525|NCT01358864|E1|Reported Event|Relapser & Partial: Placebo|Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
260526|NCT01358825|B3|Baseline|Total|Total of all reporting groups
260527|NCT01358825|B2|Baseline|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
260528|NCT01358825|B1|Baseline|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
260529|NCT01358825|P2|Participant Flow|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
260530|NCT01358825|P1|Participant Flow|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
260531|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
260532|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
260533|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
260534|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
260535|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
260795|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
260538|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
260539|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
260540|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
260541|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
260542|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
260543|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
260544|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
260545|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
260546|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
260547|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
260548|NCT01358825|E2|Reported Event|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
260549|NCT01358825|E1|Reported Event|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
260550|NCT01358760|B4|Baseline|Total|Total of all reporting groups
260551|NCT01358760|B3|Baseline|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260552|NCT01358760|B2|Baseline|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260553|NCT01358760|B1|Baseline|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260554|NCT01358760|P3|Participant Flow|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260555|NCT01358760|P2|Participant Flow|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260556|NCT01358760|P1|Participant Flow|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260557|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260558|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260559|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260560|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260561|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260562|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260563|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260564|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260565|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260566|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260567|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260568|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260569|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260570|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260571|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260572|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
282602|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
260573|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260574|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260575|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260576|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260577|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260578|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260579|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260580|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260581|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260582|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260583|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260584|NCT01358760|E3|Reported Event|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260585|NCT01358760|E2|Reported Event|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260586|NCT01358760|E1|Reported Event|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
260587|NCT01358734|B4|Baseline|Total|Total of all reporting groups
260588|NCT01358734|B3|Baseline|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
260589|NCT01358734|B2|Baseline|Azacitidine + Lenalidomide|Azacitidine 75 mg/m^2/ daily subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg daily PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
260590|NCT01358734|B1|Baseline|Lenalidomide|Lenalidomide 50 mg/day by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg daily PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily
260591|NCT01358734|P3|Participant Flow|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
260592|NCT01358734|P2|Participant Flow|Azacitidine Plus Lenalidomide|Azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
260593|NCT01358734|P1|Participant Flow|Lenalidomide|Lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus best supportive care (BSC), including antibiotics and transfusions, at the investigator's discretion.
260594|NCT01358734|O3|Outcome|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
260595|NCT01358734|O2|Outcome|Azacitidine Plus Lenalidomide|Azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
260596|NCT01358734|O1|Outcome|Lenalidomide|Lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus best supportive care (BSC), including antibiotics and transfusions, at the investigator's discretion.
260597|NCT01358734|O3|Outcome|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
260598|NCT01358734|O2|Outcome|Azacitidine Plus Lenalidomide|Azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
260599|NCT01358734|O1|Outcome|Lenalidomide|Lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus best supportive care (BSC), including antibiotics and transfusions, at the investigator's discretion.
260600|NCT01358734|O3|Outcome|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
260601|NCT01358734|O2|Outcome|Azacitidine Plus Lenalidomide|Azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
260602|NCT01358734|O1|Outcome|Lenalidomide|Lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus best supportive care (BSC), including antibiotics and transfusions, at the investigator's discretion.
260603|NCT01358734|O3|Outcome|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
260604|NCT01358734|O2|Outcome|Azacitidine Plus Lenalidomide|Azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
260748|NCT01358175|B2|Baseline|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
260605|NCT01358734|O1|Outcome|Lenalidomide|Lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus best supportive care (BSC), including antibiotics and transfusions, at the investigator's discretion.
260606|NCT01358734|E3|Reported Event|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
260607|NCT01358734|E2|Reported Event|Azacitidine Plus Lenalidomide|Azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
260608|NCT01358734|E1|Reported Event|Lenalidomide|Lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus best supportive care (BSC), including antibiotics and transfusions, at the investigator's discretion.
260609|NCT01358708|B3|Baseline|Total|Total of all reporting groups
260610|NCT01358708|B2|Baseline|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
260611|NCT01358708|B1|Baseline|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
260612|NCT01358708|P2|Participant Flow|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
260613|NCT01358708|P1|Participant Flow|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
260614|NCT01358708|O3|Outcome|LACTEOL® 340 mg Open-Label Period|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
260615|NCT01358708|O2|Outcome|PLACEBO Double-Blind Period|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
260616|NCT01358708|O1|Outcome|LACTEOL® 340 mg Double-Blind Period|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
260617|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
260618|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
260619|NCT01358708|O2|Outcome|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
260620|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
260621|NCT01358708|O2|Outcome|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
260622|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
260623|NCT01358708|O2|Outcome|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
260624|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
260625|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
260626|NCT01358708|O2|Outcome|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
260627|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
260628|NCT01358708|E3|Reported Event|LACTEOL® 340 mg Open-Label Period|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
260629|NCT01358708|E2|Reported Event|PLACEBO Double-Blind Period|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
260630|NCT01358708|E1|Reported Event|LACTEOL® 340 mg Double-Blind Period|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
260631|NCT01358578|B5|Baseline|Total|Total of all reporting groups
260632|NCT01358578|B4|Baseline|Etanercept|Etanercept
260633|NCT01358578|B3|Baseline|Placebo|Placebo
260634|NCT01358578|B2|Baseline|AIN457 300mg|AIN457 300mg
260635|NCT01358578|B1|Baseline|AIN457 150mg|AIN457 150mg
260636|NCT01358578|P6|Participant Flow|AIN457 300mg From Placebo|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 300 in maintenance
260637|NCT01358578|P5|Participant Flow|AIN457 150mg From Placebo|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 150 in maintenance
260638|NCT01358578|P4|Participant Flow|Etanercept|"Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c.~injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab."
260699|NCT01358526|O1|Outcome|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
260639|NCT01358578|P3|Participant Flow|Placebo|s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
260640|NCT01358578|P2|Participant Flow|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
260641|NCT01358578|P1|Participant Flow|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
260642|NCT01358578|O6|Outcome|Etanercept|Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab
260643|NCT01358578|O5|Outcome|Placebo|s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to treatment groups based on their PASI 75 response status at Week 12:
260644|NCT01358578|O4|Outcome|PLACEBO-300 mg AIN457|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 300 in maintenance
260645|NCT01358578|O3|Outcome|PLACEBO-150 mg AIN457|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 150 in maintenance
260646|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
260647|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
260648|NCT01358578|O3|Outcome|Etanercept|etanercept 50 mg twice per week until Week 12
260649|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
260650|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
260651|NCT01358578|O3|Outcome|Placebo|AIN457A exact match Placebo
260652|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
260653|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
260654|NCT01358578|O3|Outcome|Etanercept|Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.
260655|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
260656|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
260657|NCT01358578|O3|Outcome|Etanercept|Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.
260658|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
260659|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
260660|NCT01358578|O3|Outcome|Etanercept|Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.
260661|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
260662|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
260700|NCT01358526|O2|Outcome|Placebo Group|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
260663|NCT01358578|O3|Outcome|Etanercept|Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.
260664|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
260665|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
260666|NCT01358578|O4|Outcome|Placebo|s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
260667|NCT01358578|O3|Outcome|Etanercept|"Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c.~injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab."
260668|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
260669|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
260670|NCT01358578|O3|Outcome|Placebo|s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
260671|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
260672|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
260673|NCT01358578|O3|Outcome|Placebo|s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
260674|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
260675|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
260676|NCT01358578|E14|Reported Event|FOLLOW UP-Etanercept|FOLLOW UP-Etanercept
260677|NCT01358578|E13|Reported Event|FOLLOW UP-Placebo|FOLLOW UP-Placebo
260678|NCT01358578|E12|Reported Event|FOLLOW UP-Any AIN457 300mg|FOLLOW UP-Any AIN457 300mg
260679|NCT01358578|E11|Reported Event|FOLLOW UP-Any AIN457 150mg|FOLLOW UP-Any AIN457 150mg
260680|NCT01358578|E10|Reported Event|ENTIRE-Etanercept|ENTIRE-Etanercept
260681|NCT01358578|E9|Reported Event|ENTIRE-Placebo|ENTIRE-Placebo
260682|NCT01358578|E8|Reported Event|ENTIRE-Any AIN457 300mg|ENTIRE-Any AIN457 300mg
260683|NCT01358578|E7|Reported Event|ENTIRE-Any AIN457 150mg|ENTIRE-Any AIN457 150mg
260684|NCT01358578|E6|Reported Event|ENTIRE-AIN457 300mg|ENTIRE-AIN457 300mg
260685|NCT01358578|E5|Reported Event|ENTIRE-AIN457 150mg|ENTIRE-AIN457 150mg
260686|NCT01358578|E4|Reported Event|INDUCTION-Etanercept|INDUCTION-Etanercept
260687|NCT01358578|E3|Reported Event|INDUCTION-Placebo|INDUCTION-Placebo
260688|NCT01358578|E2|Reported Event|INDUCTION-AIN457 300mg|INDUCTION-AIN457 300mg
260689|NCT01358578|E1|Reported Event|INDUCTION-AIN457 150mg|INDUCTION-AIN457 150mg
260690|NCT01358526|B3|Baseline|Total|Total of all reporting groups
260691|NCT01358526|B2|Baseline|Placebo Group|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
260692|NCT01358526|B1|Baseline|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
260693|NCT01358526|P3|Participant Flow|Placebo Group|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
260694|NCT01358526|P2|Participant Flow|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
260695|NCT01358526|P1|Participant Flow|Open-label Titration OXN|The open-label titration was designed to identify a stable, effective, and tolerable dose of OXN for each subject.
260696|NCT01358526|O2|Outcome|Placebo Group|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
260697|NCT01358526|O1|Outcome|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
260746|NCT01358175|B4|Baseline|Total|Total of all reporting groups
260701|NCT01358526|O1|Outcome|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
260702|NCT01358526|O2|Outcome|Placebo Group|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
260703|NCT01358526|O1|Outcome|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
260704|NCT01358526|O2|Outcome|Placebo Group|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
260705|NCT01358526|O1|Outcome|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
260706|NCT01358526|E3|Reported Event|Double-blind OXN|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
260707|NCT01358526|E2|Reported Event|Double-blind Placebo|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
260708|NCT01358526|E1|Reported Event|Open-label Titration OXN|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
260709|NCT01358357|B3|Baseline|Total|Total of all reporting groups
260710|NCT01358357|B2|Baseline|Placebo|Placebo: 20-80 mg flexible dose
260711|NCT01358357|B1|Baseline|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
260712|NCT01358357|P3|Participant Flow|All Subjects|During the Open-label stabilization phase, subjects received flexible does of lurasidone 20 - 80 mg daily.
260713|NCT01358357|P2|Participant Flow|Placebo|Placebo: 20-80 mg flexible dose
260714|NCT01358357|P1|Participant Flow|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
260715|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
260716|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
260717|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
260718|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
260719|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
260720|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
260721|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
260722|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
260723|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
260724|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
260725|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
260726|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
260727|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
260728|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
260729|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
260730|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
260731|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
260732|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
260733|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
260734|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
260735|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
260736|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
260737|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
260738|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
260739|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
260740|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
260741|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
260742|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
260743|NCT01358357|E3|Reported Event|All Subjects|During the open-label stabilization phase, subjects received flexible does of lurasidone 20-80 mg daily
260744|NCT01358357|E2|Reported Event|Placebo|Placebo: 20-80 mg flexible dose
260745|NCT01358357|E1|Reported Event|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
260749|NCT01358175|B1|Baseline|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
260750|NCT01358175|P3|Participant Flow|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
260751|NCT01358175|P2|Participant Flow|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
260752|NCT01358175|P1|Participant Flow|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
260753|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
260754|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
260755|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
260756|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
260757|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
260758|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
260759|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
260760|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
260761|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
260762|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
260763|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
260764|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
260765|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
260766|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
260767|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
260768|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
260769|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
260770|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
260771|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
260772|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
260773|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
260774|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
260775|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
260776|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
260777|NCT01358175|E7|Reported Event|Placebo Resp Secukinumab 150 mg|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 24 to Secukinumab 150 mg
260778|NCT01358175|E6|Reported Event|Placebo Resp Secukinumab 75 mg|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 24 to Secukinumab 75 mg
260779|NCT01358175|E5|Reported Event|Placebo Non-Resp Secukinumab 150 mg|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 16 to Secukinumab 150 mg
260780|NCT01358175|E4|Reported Event|Placebo Non-Resp Secukinumab 75 mg|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 16 to Secukinumab 75 mg
260781|NCT01358175|E3|Reported Event|Placebo Secukinumab|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 up to end of Study
260782|NCT01358175|E2|Reported Event|Secukinumab 10mg/kg -150 mg|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
260783|NCT01358175|E1|Reported Event|Secukinumab 10mg/kg -75 mg|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
260784|NCT01357980|B5|Baseline|Total|Total of all reporting groups
260785|NCT01357980|B4|Baseline|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
260786|NCT01357980|B3|Baseline|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
260787|NCT01357980|B2|Baseline|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
260788|NCT01357980|B1|Baseline|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
260796|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
260797|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
260798|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
260799|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
260800|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
260801|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
260802|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
260803|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
260804|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
260805|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
260806|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
260807|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
260808|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
260809|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
260810|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
260811|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
260812|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
260813|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
260814|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
260815|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
260816|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
260817|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
260818|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
260819|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
260820|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
260821|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
260822|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
260823|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
260824|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
260825|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
260826|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
260827|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
260828|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
260829|NCT01357980|E4|Reported Event|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
260830|NCT01357980|E3|Reported Event|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U using different administration regimen, intra detrusor injection on day 1 (single dose)
260831|NCT01357980|E2|Reported Event|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
260832|NCT01357980|E1|Reported Event|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U using different administration regimen, intra detrusor injection on day 1 (single dose)
260833|NCT01357915|B3|Baseline|Total|Total of all reporting groups
260834|NCT01357915|B2|Baseline|GSK149203A S+ Group|Male subjects who were assessed as being naturally infected with CMV at the screening visit of the primary study 108890 (NCT00435396).
260835|NCT01357915|B1|Baseline|GSK149203A S- Group|Male subjects who received 3 doses of GSK Biologicals’ candidate GSK149203A vaccine according to a 0-1-6 month schedule in the primary study 108890 (NCT00435396).
260836|NCT01357915|P2|Participant Flow|GSK149203A S+ Group|Male subjects who were assessed as being naturally infected with Cytomegalovirus (CMV) at the screening visit of the primary study 108890 (NCT00435396).
260837|NCT01357915|P1|Participant Flow|GSK149203A S- Group|Male subjects who received 3 doses of GSK Biologicals’ candidate GSK149203A vaccine according to a 0-1-6 month schedule in the primary study 108890 (NCT00435396).
260838|NCT01357915|O1|Outcome|GSK149203A S- Group|Male subjects who received 3 doses of GSK Biologicals’ candidate GSK149203A vaccine according to a 0-1-6 month schedule in the primary study 108890 (NCT00435396).
260839|NCT01357915|O2|Outcome|GSK149203A S+ Group|Male subjects who were assessed as being naturally infected with CMV at the screening visit of the primary study 108890 (NCT00435396).
260840|NCT01357915|O1|Outcome|GSK149203A S- Group|Male subjects who received 3 doses of GSK Biologicals’ candidate GSK149203A vaccine according to a 0-1-6 month schedule in the primary study 108890 (NCT00435396).
261101|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
282603|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
260841|NCT01357915|O2|Outcome|GSK149203A S+ Group|Male subjects who were assessed as being naturally infected with CMV at the screening visit of the primary study 108890 (NCT00435396).
260842|NCT01357915|O1|Outcome|GSK149203A S- Group|Male subjects who received 3 doses of GSK Biologicals’ candidate GSK149203A vaccine according to a 0-1-6 month schedule in the primary study 108890 (NCT00435396).
260843|NCT01357915|O2|Outcome|GSK149203A S+ Group|Male subjects who were assessed as being naturally infected with CMV at the screening visit of the primary study 108890 (NCT00435396).
260844|NCT01357915|O1|Outcome|GSK149203A S- Group|Male subjects who received 3 doses of GSK Biologicals’ candidate GSK149203A vaccine according to a 0-1-6 month schedule in the primary study 108890 (NCT00435396).
260845|NCT01357915|O2|Outcome|GSK149203A S+ Group|Male subjects who were assessed as being naturally infected with CMV at the screening visit of the primary study 108890 (NCT00435396).
260846|NCT01357915|O1|Outcome|GSK149203A S- Group|Male subjects who received 3 doses of GSK Biologicals’ candidate GSK149203A vaccine according to a 0-1-6 month schedule in the primary study 108890 (NCT00435396).
260847|NCT01357915|E2|Reported Event|GSK149203A S+ Group|Male subjects who were assessed as being naturally infected with Cytomegalovirus (CMV) at the screening visit of the primary study 108890 (NCT00435396).
260848|NCT01357915|E1|Reported Event|GSK149203A S- Group|Male subjects who received 3 doses of GSK Biologicals’ candidate GSK149203A vaccine according to a 0-1-6 month schedule in the primary study 108890 (NCT00435396).
260849|NCT01357889|B3|Baseline|Total|Total of all reporting groups
260850|NCT01357889|B2|Baseline|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
260851|NCT01357889|B1|Baseline|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
260852|NCT01357889|P2|Participant Flow|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
260853|NCT01357889|P1|Participant Flow|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
260854|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260855|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260856|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260857|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260858|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
260879|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260859|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
260860|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
260861|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
260862|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
260863|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
260864|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
260865|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
260866|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
260880|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260881|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
261102|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
260867|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
260868|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
260869|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
260870|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
260871|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
260872|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
260873|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
260874|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260875|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260876|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260877|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260878|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
261059|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
260882|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260883|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260884|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260885|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260886|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
260887|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
260888|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
260889|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
260890|NCT01357889|E2|Reported Event|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
260891|NCT01357889|E1|Reported Event|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
260892|NCT01357850|B5|Baseline|Total|Total of all reporting groups
260893|NCT01357850|B4|Baseline|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260894|NCT01357850|B3|Baseline|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260895|NCT01357850|B2|Baseline|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260896|NCT01357850|B1|Baseline|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260897|NCT01357850|P4|Participant Flow|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
261060|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
260898|NCT01357850|P3|Participant Flow|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260899|NCT01357850|P2|Participant Flow|Albiglutide 3.75 mg|Participants received albiglutide 3.75 milligrams (mg) weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260900|NCT01357850|P1|Participant Flow|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260901|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260902|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260903|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260904|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260905|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260906|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260907|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260908|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260909|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260910|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260911|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260912|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260913|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260914|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260915|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260916|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260917|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260918|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260919|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260920|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260921|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260922|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260923|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260924|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260925|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260926|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260927|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260928|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260929|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260930|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260931|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260932|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
261061|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
260933|NCT01357850|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260934|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260935|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260936|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260937|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260938|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260939|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260940|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260941|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260942|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260943|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260944|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260945|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260946|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260947|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260948|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260949|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260950|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260951|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260952|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260953|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260954|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260955|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260956|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260957|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260958|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260959|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260960|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260961|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260962|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260963|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260964|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260965|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260966|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260967|NCT01357850|E4|Reported Event|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
261062|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
260968|NCT01357850|E3|Reported Event|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260969|NCT01357850|E2|Reported Event|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260970|NCT01357850|E1|Reported Event|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
260971|NCT01357720|B3|Baseline|Total|Total of all reporting groups
260972|NCT01357720|B2|Baseline|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
260973|NCT01357720|B1|Baseline|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
260974|NCT01357720|P2|Participant Flow|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
260975|NCT01357720|P1|Participant Flow|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
260976|NCT01357720|O2|Outcome|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
260977|NCT01357720|O1|Outcome|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
260978|NCT01357720|O2|Outcome|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
260979|NCT01357720|O1|Outcome|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
260980|NCT01357720|O2|Outcome|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
260981|NCT01357720|O1|Outcome|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
260982|NCT01357720|O2|Outcome|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
260983|NCT01357720|O1|Outcome|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
260984|NCT01357720|O2|Outcome|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
260985|NCT01357720|O1|Outcome|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
260986|NCT01357720|E2|Reported Event|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
260987|NCT01357720|E1|Reported Event|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
260988|NCT01357655|B3|Baseline|Total|Total of all reporting groups
260989|NCT01357655|B2|Baseline|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).~Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
260990|NCT01357655|B1|Baseline|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
260991|NCT01357655|P2|Participant Flow|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).~Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
260992|NCT01357655|P1|Participant Flow|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
260993|NCT01357655|O2|Outcome|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).~Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
260994|NCT01357655|O1|Outcome|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
260995|NCT01357655|O2|Outcome|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).~Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
260996|NCT01357655|O1|Outcome|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
260997|NCT01357655|O2|Outcome|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).~Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
260998|NCT01357655|O1|Outcome|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
261063|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
261064|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
261065|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
260999|NCT01357655|O2|Outcome|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).~Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
261000|NCT01357655|O1|Outcome|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
261001|NCT01357655|O2|Outcome|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).~Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
261002|NCT01357655|O1|Outcome|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
261003|NCT01357655|O2|Outcome|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).~Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
261004|NCT01357655|O1|Outcome|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
261005|NCT01357655|E1|Reported Event|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, Once daily, approximately 1 year
261006|NCT01357616|B3|Baseline|Total|Total of all reporting groups
261007|NCT01357616|B2|Baseline|AZOPT + TIMOLOL|Brinzolamide 1% ophthalmic suspension and Timolol 0.5% ophthalmic solution, 1 drop of each component instilled in the affected eye(s), waiting approximately 10 minutes between instillation of the 2 drops. Study drugs were instilled twice daily (9AM and 9PM) for 8 weeks.
261008|NCT01357616|B1|Baseline|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
261009|NCT01357616|P2|Participant Flow|AZOPT + TIMOLOL|Brinzolamide 1% ophthalmic suspension and Timolol 0.5% ophthalmic solution, 1 drop of each component instilled in the affected eye(s), waiting approximately 10 minutes between instillation of the 2 drops. Study drugs were instilled twice daily (9AM and 9PM) for 8 weeks.
261010|NCT01357616|P1|Participant Flow|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
261011|NCT01357616|O2|Outcome|AZOPT + Timolol|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in the affected eye(s), followed by Timolol 0.5% ophthalmic solution, 1 drop instilled in the affected eye(s). Approximately 10 minutes separated the 2 instillations. The study drugs were instilled twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
261012|NCT01357616|O1|Outcome|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
261013|NCT01357616|O2|Outcome|AZOPT + Timolol|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in the affected eye(s), followed by Timolol 0.5% ophthalmic solution, 1 drop instilled in the affected eye(s). Approximately 10 minutes separated the 2 instillations. The study drugs were instilled twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
261014|NCT01357616|O1|Outcome|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
261015|NCT01357616|O2|Outcome|AZOPT + Timolol|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in the affected eye(s), followed by Timolol 0.5% ophthalmic solution, 1 drop instilled in the affected eye(s). Approximately 10 minutes separated the 2 instillations. The study drugs were instilled twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
261016|NCT01357616|O1|Outcome|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
261017|NCT01357616|O2|Outcome|AZOPT + Timolol|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in the affected eye(s), followed by Timolol 0.5% ophthalmic solution, 1 drop instilled in the affected eye(s). Approximately 10 minutes separated the 2 instillations. The study drugs were instilled twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
261018|NCT01357616|O1|Outcome|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
261019|NCT01357616|E2|Reported Event|AZOPT + TIMOLOL (Control Group)|"Brinzolamide 1% ophthalmic suspension and Timolol 0.5% ophthalmic solution, 1 drop of each component instilled in the affected eye(s), waiting approximately 10 minutes between instillation of the 2 drops. Study drugs were instilled twice daily (9AM and 9PM) for 8 weeks.~Brinzolamide 1% ophthalmic suspension and Timolol 0.5% ophthalmic solution"
261020|NCT01357616|E1|Reported Event|AZARGA (Test Group)|"Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks.~Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension"
261021|NCT01357551|B3|Baseline|Total|Total of all reporting groups
261022|NCT01357551|B2|Baseline|Usual Care|Participants are randomized to receive usual care for 56 weeks
261023|NCT01357551|B1|Baseline|Maintenance Intervention|"Participants are randomized to a theoretically-informed maintenance intervention for 42 weeks, followed by 14 weeks of no intervention contact to examine sustainability. The maintenance intervention will involve in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time.~Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time."
261024|NCT01357551|P2|Participant Flow|Usual Care|Participants receive usual care for 56 weeks
261025|NCT01357551|P1|Participant Flow|Maintenance Intervention|"Participants receive theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability.~Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist gradually decreases over time."
261026|NCT01357551|O2|Outcome|Usual Care|Participants receive usual care for 56 weeks
261027|NCT01357551|O1|Outcome|Maintenance Intervention|"Participants receive theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability.~Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist gradually decreases over time."
261028|NCT01357551|O2|Outcome|Usual Care|Participants receive usual care for 56 weeks
261029|NCT01357551|O1|Outcome|Maintenance Intervention|"Participants receive a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time.~Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time."
261030|NCT01357551|O2|Outcome|Usual Care|Participants receive usual care for 56 weeks
261031|NCT01357551|O1|Outcome|Maintenance Intervention|"Participants receive a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time.~Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time."
261032|NCT01357551|O2|Outcome|Usual Care|Participants are randomized to receive usual care for 56 weeks
261033|NCT01357551|O1|Outcome|Maintenance Intervention|"Participants are randomized to a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention will involve in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time.~Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time."
261034|NCT01357551|E2|Reported Event|Usual Care|Participants receive usual care for 56 weeks
261035|NCT01357551|E1|Reported Event|Maintenance Intervention|"Participants receive a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time.~Maintenance intervention: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time."
261036|NCT01357512|B3|Baseline|Total|Total of all reporting groups
261037|NCT01357512|B2|Baseline|no MRI|No MRI before prostate biopsies
261038|NCT01357512|B1|Baseline|MRI Done|"Subjects with MRI prior prostate biopsies~magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device"
261039|NCT01357512|P2|Participant Flow|no MRI|No MRI before prostate biopsies
261040|NCT01357512|P1|Participant Flow|MRI Done|"Subjects with MRI prior prostate biopsies~magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device"
261041|NCT01357512|O2|Outcome|no MRI|No MRI before prostate biopsies
261042|NCT01357512|O1|Outcome|MRI Done|"Subjects with MRI prior prostate biopsies~magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device"
261043|NCT01357512|O2|Outcome|no MRI|No MRI before prostate biopsies
261044|NCT01357512|O1|Outcome|MRI Done|"Subjects with MRI prior prostate biopsies~magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device"
261045|NCT01357512|E2|Reported Event|no MRI|No MRI before prostate biopsies
261046|NCT01357512|E1|Reported Event|MRI Done|"Subjects with MRI prior prostate biopsies~magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device"
261047|NCT01357239|B5|Baseline|Total|Total of all reporting groups
261048|NCT01357239|B4|Baseline|Placebo|2 capsules of placebo per intake
261049|NCT01357239|B3|Baseline|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
261050|NCT01357239|B2|Baseline|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
261051|NCT01357239|B1|Baseline|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
261052|NCT01357239|P4|Participant Flow|Placebo|2 capsules of placebo per intake
261053|NCT01357239|P3|Participant Flow|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
261054|NCT01357239|P2|Participant Flow|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
261055|NCT01357239|P1|Participant Flow|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
261056|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
261057|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
261058|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
261104|NCT01357239|O1|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
261105|NCT01357239|E4|Reported Event|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
261106|NCT01357239|E3|Reported Event|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
261107|NCT01357239|E2|Reported Event|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
261108|NCT01357239|E1|Reported Event|Placebo|2 capsules of placebo per intake
261109|NCT01357161|B4|Baseline|Total|Total of all reporting groups
261110|NCT01357161|B3|Baseline|Part 2: Placebo + Paclitaxel +Carboplatin|During Part 2, participants received matched placebo to MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received placebo in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
261111|NCT01357161|B2|Baseline|Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin|During Part 2, participants received 225 mg MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
261112|NCT01357161|B1|Baseline|Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin|During the open-label run-in, participants received 225 mg MK-1775 twice daily (BID) starting on Day 1 of Cycle 1 (cycle=21 days) for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (area under the curve [AUC] 5).
261113|NCT01357161|P3|Participant Flow|Part 2: Placebo + Paclitaxel +Carboplatin|During Part 2, participants received matched placebo to MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received placebo in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
261114|NCT01357161|P2|Participant Flow|Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin|During Part 2, participants received 225 mg MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
261115|NCT01357161|P1|Participant Flow|Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin|During the open-label run-in, participants received 225 mg MK-1775 twice daily (BID) starting on Day 1 of Cycle 1 (cycle=21 days) for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (area under the curve [AUC] 5).
261116|NCT01357161|O3|Outcome|Part 2: Placebo + Paclitaxel +Carboplatin|During Part 2, participants received matched placebo to MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received placebo in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
261117|NCT01357161|O2|Outcome|Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin|During Part 2, participants received 225 mg MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
261118|NCT01357161|O1|Outcome|Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin|During the open-label run-in, participants received 225 mg MK-1775 twice daily (BID) starting on Day 1 of Cycle 1 (cycle=21 days) for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (area under the curve [AUC] 5).
261119|NCT01357161|O3|Outcome|Part 2: Placebo + Paclitaxel +Carboplatin|During Part 2, participants received matched placebo to MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received placebo in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
261120|NCT01357161|O2|Outcome|Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin|During Part 2, participants received 225 mg MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
261121|NCT01357161|O1|Outcome|Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin|During the open-label run-in, participants received 225 mg MK-1775 twice daily (BID) starting on Day 1 of Cycle 1 (cycle=21 days) for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (area under the curve [AUC] 5).
261122|NCT01357161|O3|Outcome|Part 2: Placebo + Paclitaxel +Carboplatin|During Part 2, participants received matched placebo to MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received placebo in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
261123|NCT01357161|O2|Outcome|Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin|During Part 2, participants received 225 mg MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
261124|NCT01357161|O1|Outcome|Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin|During the open-label run-in, participants received 225 mg MK-1775 twice daily (BID) starting on Day 1 of Cycle 1 (cycle=21 days) for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (area under the curve [AUC] 5).
261125|NCT01357161|O3|Outcome|Part 2: Placebo + Paclitaxel +Carboplatin|During Part 2, participants received matched placebo to MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received placebo in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
261126|NCT01357161|O2|Outcome|Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin|During Part 2, participants received 225 mg MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
261127|NCT01357161|O1|Outcome|Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin|During the open-label run-in, participants received 225 mg MK-1775 twice daily (BID) starting on Day 1 of Cycle 1 (cycle=21 days) for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (area under the curve [AUC] 5).
261128|NCT01357161|O3|Outcome|Part 2: Placebo + Paclitaxel +Carboplatin|During Part 2, participants received matched placebo to MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received placebo in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
261129|NCT01357161|O2|Outcome|Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin|During Part 2, participants received 225 mg MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
261159|NCT01357135|O2|Outcome|Metformin + Sulfonylurea|Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
261516|NCT01355289|O1|Outcome|Placebo (Core Study)|Placebo, was given orally for up to 21 days once daily.
261130|NCT01357161|O1|Outcome|Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin|During the open-label run-in, participants received 225 mg MK-1775 twice daily (BID) starting on Day 1 of Cycle 1 (cycle=21 days) for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (area under the curve [AUC] 5).
261131|NCT01357161|O3|Outcome|Part 2: Placebo + Paclitaxel +Carboplatin|During Part 2, participants received matched placebo to MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received placebo in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
261132|NCT01357161|O2|Outcome|Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin|During Part 2, participants received 225 mg MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
261133|NCT01357161|O1|Outcome|Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin|During the open-label run-in, participants received 225 mg MK-1775 twice daily (BID) starting on Day 1 of Cycle 1 (cycle=21 days) for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (area under the curve [AUC] 5).
261134|NCT01357161|O3|Outcome|Part 2: Placebo + Paclitaxel +Carboplatin|During Part 2, participants received matched placebo to MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received placebo in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
261135|NCT01357161|O2|Outcome|Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin|During Part 2, participants received 225 mg MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
261136|NCT01357161|O1|Outcome|Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin|During the open-label run-in, participants received 225 mg MK-1775 twice daily (BID) starting on Day 1 of Cycle 1 (cycle=21 days) for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (area under the curve [AUC] 5).
261137|NCT01357161|O3|Outcome|Part 2: Placebo + Paclitaxel +Carboplatin|During Part 2, participants received matched placebo to MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received placebo in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
261138|NCT01357161|O2|Outcome|Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin|During Part 2, participants received 225 mg MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
261139|NCT01357161|O1|Outcome|Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin|During the open-label run-in, participants received 225 mg MK-1775 twice daily (BID) starting on Day 1 of Cycle 1 (cycle=21 days) for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (area under the curve [AUC] 5).
261140|NCT01357161|E3|Reported Event|Part 2: Placebo + Paclitaxel +Carboplatin|During Part 2, participants received matched placebo to MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received placebo in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
261141|NCT01357161|E2|Reported Event|Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin|During Part 2, participants received 225 mg MK-1775 BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (AUC 5).
261142|NCT01357161|E1|Reported Event|Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin|During the open-label run-in, participants received 225 mg MK-1775 twice daily (BID) starting on Day 1 of Cycle 1 (cycle=21 days) for a total of 5 doses. Participants received MK-1775 in combination with paclitaxel (175 mg/m^2) and carboplatin (area under the curve [AUC] 5).
261143|NCT01357148|B1|Baseline|Sitagliptin Phosphate/Metformin HCl|Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
261144|NCT01357148|P1|Participant Flow|Sitagliptin Phosphate/Metformin HCl|Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
261145|NCT01357148|O1|Outcome|Sitagliptin Phosphate/Metformin HCl|
261146|NCT01357148|O1|Outcome|Sitagliptin Phosphate/Metformin HCl|
261147|NCT01357148|O1|Outcome|Sitagliptin Phosphate/Metformin HCl|Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
261148|NCT01357148|O1|Outcome|Sitagliptin Phosphate/Metformin HCl|Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
261149|NCT01357148|E1|Reported Event|Sitagliptin Phosphate/Metformin HCl|Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
261150|NCT01357135|B4|Baseline|Total|Total of all reporting groups
261151|NCT01357135|B3|Baseline|Sitagliptin +/- Other Antihyperglycemic Medication|Participants taking sitagliptin +/- other antihyperglycemic medications (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof.
261152|NCT01357135|B2|Baseline|Metformin + Sulfonylurea|Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
261153|NCT01357135|B1|Baseline|Metformin + Sitagliptin|Participants taking metformin + sitagliptin (Januvia®/Xelevia®) as prescribed in routine clinical practice.
261154|NCT01357135|P3|Participant Flow|Sitagliptin +/- Other Antihyperglycemic Medication|Participants taking sitagliptin +/- other antihyperglycemic medications (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof.
261155|NCT01357135|P2|Participant Flow|Metformin + Sulfonylurea|Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
261156|NCT01357135|P1|Participant Flow|Metformin + Sitagliptin|Participants taking metformin + sitagliptin (Januvia®/Xelevia®) as prescribed in routine clinical practice.
261157|NCT01357135|O2|Outcome|Metformin + Sulfonylurea|Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
261158|NCT01357135|O1|Outcome|Metformin + Sitagliptin|Participants taking metformin + sitagliptin as prescribed in routine clinical practice.
261411|NCT01355523|B3|Baseline|Total|Total of all reporting groups
261160|NCT01357135|O1|Outcome|Metformin + Sitagliptin|Participants taking metformin + sitagliptin as prescribed in routine clinical practice.
261161|NCT01357135|E3|Reported Event|Sitagliptin +/- Other Antihyperglycemic Medication|Participants taking sitagliptin +/- other antihyperglycemic medications (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof.
261162|NCT01357135|E2|Reported Event|Metformin + Sulfonylurea|Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
261163|NCT01357135|E1|Reported Event|Metformin + Sitagliptin|Participants taking metformin + sitagliptin as prescribed in routine clinical practice.
261164|NCT01356966|B3|Baseline|Total|Total of all reporting groups
261165|NCT01356966|B2|Baseline|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
261166|NCT01356966|B1|Baseline|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
261167|NCT01356966|P2|Participant Flow|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
261168|NCT01356966|P1|Participant Flow|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
261169|NCT01356966|O2|Outcome|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
261170|NCT01356966|O1|Outcome|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
261171|NCT01356966|O2|Outcome|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
261172|NCT01356966|O1|Outcome|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
261173|NCT01356966|O2|Outcome|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
261174|NCT01356966|O1|Outcome|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
261175|NCT01356966|E2|Reported Event|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
261176|NCT01356966|E1|Reported Event|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
261177|NCT01356940|B3|Baseline|Total|Total of all reporting groups
261178|NCT01356940|B2|Baseline|Placebo Followed by Dalfampridine ER 10mg Bid|"• Age 18-75 inclusive, Male or Female identical placebo tablet administered bid for four weeks~Group B: identical placebo tablet administered bid for four weeks, 2 week washout, then dalfampridine ER 10mg bid for 4 weeks"
261179|NCT01356940|B1|Baseline|Dalfampridine ER 10mg Bid Followed by Placebo|"• Age 18-75 inclusive, Male or Female 4 week administration of dalfampridine ER 10mg bid~Group A: dalfampridine ER 10mg bid for 4 weeks, 2 week washout, then matching placebo for 4 weeks"
261180|NCT01356940|P2|Participant Flow|Placebo-dalfampridine ER 10mg Bid|placebo tablet administered bid for four weeks followed by 2 week washout and dalfampridine ER: dalfampridine ER 10mg bid for 4 weeks
261181|NCT01356940|P1|Participant Flow|Dalfampridine ER 10mg Bid- Placebo|4 week administration of dalfampridine ER 10mg bid followed by 2 week washout and 4 weeks of placebo
261182|NCT01356940|O2|Outcome|Placebo|"identical placebo tablet administered bid for four weeks~placebo: identical placebo tablet administered bid for four weeks"
261183|NCT01356940|O1|Outcome|Dalfampridine ER 10mg Bid|"4 week administration of dalfampridine ER 10mg bid~dalfampridine ER: dalfampridine ER 10mg bid for 4 weeks"
261184|NCT01356940|E2|Reported Event|Placebo|"identical placebo tablet administered bid for four weeks~placebo: identical placebo tablet administered bid for four weeks"
261185|NCT01356940|E1|Reported Event|Dalfampridine ER 10mg Bid|"4 week administration of dalfampridine ER 10mg bid~dalfampridine ER: dalfampridine ER 10mg bid for 4 weeks"
261186|NCT01356667|B3|Baseline|Total|Total of all reporting groups
261187|NCT01356667|B2|Baseline|Drum-Assisted Recovery Therapy for Native Americans|12-week treatment protocol consisting of drum therapy for Native Americans
261188|NCT01356667|B1|Baseline|Treatment-As-Usual|Substance Abuse treatment typically received at United American Indian Involvement (UAII)
261189|NCT01356667|P2|Participant Flow|Drum-Assisted Recovery Therapy for Native Americans|12-week treatment protocol consisting of drum therapy for Native Americans
261190|NCT01356667|P1|Participant Flow|Treatment-As-Usual|Substance Abuse treatment typically received at United American Indian Involvement (UAII)
261191|NCT01356667|O2|Outcome|DARTNA|"12-week DARTNA program~DARTNA: 3-hour protocol provided 2x/week over 12 weeks"
261192|NCT01356667|O1|Outcome|Treatment-As-Usual|"Substance Abuse treatment typically received~Treatment-As-Usual: Participants will receive typical substance abuse behavior treatment interventions typically provided to patients including individual counseling, group therapy, and standard culturally-based interventions."
261193|NCT01356667|O2|Outcome|Drum-Assisted Recovery Therapy for Native Americans|12-week treatment protocol consisting of drum therapy for Native Americans
261194|NCT01356667|O1|Outcome|Treatment-As-Usual|Substance Abuse treatment typically received at United American Indian Involvement (UAII)
261195|NCT01356667|O2|Outcome|Drum-Assisted Recovery Therapy for Native Americans|12-week treatment protocol consisting of drum therapy for Native Americans
261196|NCT01356667|O1|Outcome|Treatment-As-Usual|Substance Abuse treatment typically received at United American Indian Involvement (UAII)
261197|NCT01356667|E2|Reported Event|Drum-Assisted Recovery Therapy for Native Americans|12-week treatment protocol consisting of drum therapy for Native Americans
261198|NCT01356667|E1|Reported Event|Treatment-As-Usual|Substance Abuse treatment typically received at United American Indian Involvement (UAII)
261199|NCT01356628|B1|Baseline|PD-0332991|"PD-0332991 in the Treatment in Patients with Advanced Hepatocellular Carcinoma~PD-0332991: PD-0332991, 125mg, 3 cycles"
261200|NCT01356628|P1|Participant Flow|PD-0332991|"PD-0332991 in the Treatment in Patients with Advanced Hepatocellular Carcinoma~PD-0332991: PD-0332991, 125mg, 3 cycles"
261201|NCT01356628|O1|Outcome|PD-0332991|"PD-0332991 in the Treatment in Patients with Advanced Hepatocellular Carcinoma~PD-0332991: PD-0332991, 125mg, 3 cycles"
261202|NCT01356628|O1|Outcome|PD-0332991|"PD-0332991 in the Treatment in Patients with Advanced Hepatocellular Carcinoma~PD-0332991: PD-0332991, 125mg, 3 cycles"
261203|NCT01356628|E1|Reported Event|PD-0332991|"PD-0332991 in the Treatment in Patients with Advanced Hepatocellular Carcinoma~PD-0332991: PD-0332991, 125mg, 3 cycles"
261204|NCT01356602|B4|Baseline|Total|Total of all reporting groups
261205|NCT01356602|B3|Baseline|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
261206|NCT01356602|B2|Baseline|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
261207|NCT01356602|B1|Baseline|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
261208|NCT01356602|P3|Participant Flow|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
261209|NCT01356602|P2|Participant Flow|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
261210|NCT01356602|P1|Participant Flow|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
261211|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
261212|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
261213|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
261214|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
261215|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
261216|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
261217|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
261218|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
261219|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
261220|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
261221|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
261222|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
261223|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
261224|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
261225|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
261226|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
261412|NCT01355523|B2|Baseline|Placebo|6 mg oral placebo daily
261227|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
261228|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
261229|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
261230|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
261231|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
261232|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
261233|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
261234|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
261235|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
261236|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
261237|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
261238|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
261239|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
261240|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
261241|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
261242|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
261243|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
261244|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
261245|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
261246|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
261247|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
261248|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
261249|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
261250|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
261251|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
261252|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
261253|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
261254|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
261255|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
261256|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
261257|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
261258|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
261259|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
261260|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
261261|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
261262|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
261263|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
261264|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
261265|NCT01356602|E3|Reported Event|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
261266|NCT01356602|E2|Reported Event|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
261267|NCT01356602|E1|Reported Event|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
261268|NCT01356589|B1|Baseline|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants’ medical files.
261269|NCT01356589|P1|Participant Flow|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants’ medical files.
261270|NCT01356589|O1|Outcome|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants’ medical files.
261271|NCT01356589|O1|Outcome|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants’ medical files.
261272|NCT01356589|O1|Outcome|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants’ medical files.
261273|NCT01356589|E1|Reported Event|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants’ medical files.
261274|NCT01356498|B7|Baseline|Total|Total of all reporting groups
261275|NCT01356498|B6|Baseline|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261413|NCT01355523|B1|Baseline|Melatonin|6 mg oral melatonin daily
261414|NCT01355523|P2|Participant Flow|Placebo|6 mg oral placebo daily
261276|NCT01356498|B5|Baseline|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261277|NCT01356498|B4|Baseline|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261278|NCT01356498|B3|Baseline|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
261279|NCT01356498|B2|Baseline|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261280|NCT01356498|B1|Baseline|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
261281|NCT01356498|P6|Participant Flow|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261282|NCT01356498|P5|Participant Flow|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261283|NCT01356498|P4|Participant Flow|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261284|NCT01356498|P3|Participant Flow|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
261285|NCT01356498|P2|Participant Flow|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261286|NCT01356498|P1|Participant Flow|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
261287|NCT01356498|O6|Outcome|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261288|NCT01356498|O5|Outcome|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261289|NCT01356498|O4|Outcome|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261290|NCT01356498|O3|Outcome|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
261291|NCT01356498|O2|Outcome|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261292|NCT01356498|O1|Outcome|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
261293|NCT01356498|O6|Outcome|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261294|NCT01356498|O5|Outcome|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261295|NCT01356498|O4|Outcome|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261296|NCT01356498|O3|Outcome|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
261297|NCT01356498|O2|Outcome|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261298|NCT01356498|O1|Outcome|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
261299|NCT01356498|O6|Outcome|Placebo in RCT, q4 in OLE|Placebo arm in RCT, initiated pegloticase treatment q4 wk in OLE
261300|NCT01356498|O5|Outcome|q4 RCT, Non-responder|Non-responder in Pegloticase every 4 wk arm of RCT, continued to received pegloticase (q2 wk or q4 wk) in OLE
261301|NCT01356498|O4|Outcome|q2 RCT, Non-responder|Non-responder in pegloticase every 2 wk arm of RCT, continued to received pegloticase (q2 wk or q4 wk) in OLE
261302|NCT01356498|O3|Outcome|Placebo in RCT, q2 in OLE|Placebo arm in RCT, initiated pegloticase treatment q2 wk in OLE
261303|NCT01356498|O2|Outcome|q4 RCT Responder|REsponder in Pegloticase every 4 wk arm of RCT, contuned to received pegloticase (q2 wk or q4 wk) in OLE
261304|NCT01356498|O1|Outcome|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of RCT, continued to received pegloticase (q2 wk or q4 wk) in OLE
261305|NCT01356498|O6|Outcome|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261306|NCT01356498|O5|Outcome|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261307|NCT01356498|O4|Outcome|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261308|NCT01356498|O3|Outcome|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
261415|NCT01355523|P1|Participant Flow|Melatonin|6 mg oral melatonin daily
261309|NCT01356498|O2|Outcome|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261310|NCT01356498|O1|Outcome|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
261311|NCT01356498|O6|Outcome|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261312|NCT01356498|O5|Outcome|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261313|NCT01356498|O4|Outcome|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261314|NCT01356498|O3|Outcome|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
261315|NCT01356498|O2|Outcome|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261316|NCT01356498|O1|Outcome|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
261317|NCT01356498|E6|Reported Event|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261318|NCT01356498|E5|Reported Event|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261319|NCT01356498|E4|Reported Event|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261320|NCT01356498|E3|Reported Event|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
261321|NCT01356498|E2|Reported Event|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
261322|NCT01356498|E1|Reported Event|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
261323|NCT01356407|B3|Baseline|Total|Total of all reporting groups
261324|NCT01356407|B2|Baseline|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
261325|NCT01356407|B1|Baseline|PICOPREP|"“Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
261326|NCT01356407|P2|Participant Flow|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
261327|NCT01356407|P1|Participant Flow|PICOPREP|"“Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
261328|NCT01356407|O2|Outcome|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
261329|NCT01356407|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
261330|NCT01356407|O2|Outcome|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
261331|NCT01356407|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
261332|NCT01356407|O2|Outcome|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
261333|NCT01356407|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
261334|NCT01356407|O2|Outcome|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
261335|NCT01356407|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
261336|NCT01356407|O2|Outcome|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
261337|NCT01356407|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
261338|NCT01356407|O2|Outcome|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
261339|NCT01356407|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
261416|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
261340|NCT01356407|E2|Reported Event|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
261341|NCT01356407|E1|Reported Event|PICOPREP|"“Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
261342|NCT01356147|B3|Baseline|Total|Total of all reporting groups
261343|NCT01356147|B2|Baseline|Dornase Alfa|"Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation~Dornase alfa: 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation"
261344|NCT01356147|B1|Baseline|Sham Placebo|"No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit.~Placebo: No therapy will be given to placebo arm"
261345|NCT01356147|P2|Participant Flow|Dornase Alfa|"Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation~Dornase alfa: 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation"
261346|NCT01356147|P1|Participant Flow|Sham Placebo|"No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit.~Placebo: No therapy will be given to placebo arm"
261347|NCT01356147|O2|Outcome|Dornase Alfa|"Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation~Dornase alfa: 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation"
261348|NCT01356147|O1|Outcome|Sham Placebo|"No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit.~Placebo: No therapy will be given to placebo arm"
261349|NCT01356147|E2|Reported Event|Dornase Alfa|"Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation~Dornase alfa: 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation"
261350|NCT01356147|E1|Reported Event|Sham Placebo|"No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit.~Placebo: No therapy will be given to placebo arm"
261351|NCT01355978|B1|Baseline|Noninvasive Open Ventilation System|Portable noninvasive open ventilator & nasal interface. Noninvasive Open Ventilation System used during activities of daily living.
261352|NCT01355978|P1|Participant Flow|Noninvasive Open Ventilation System|"Portable noninvasive open ventilator & nasal interface.~Noninvasive Open Ventilation System: Noninvasive ventilation system"
261353|NCT01355978|O1|Outcome|Noninvasive Open Ventilation System|"Portable noninvasive open ventilator & nasal interface.~Noninvasive Open Ventilation System: Noninvasive ventilation system"
261354|NCT01355978|O1|Outcome|Noninvasive Open Ventilation System|"Portable noninvasive open ventilator & nasal interface.~Noninvasive Open Ventilation System: Noninvasive ventilation system"
261355|NCT01355978|O1|Outcome|Noninvasive Open Ventilation System|"Portable noninvasive open ventilator & nasal interface.~Noninvasive Open Ventilation System: Noninvasive ventilation system"
261356|NCT01355978|E1|Reported Event|Noninvasive Open Ventilation System|"Portable noninvasive open ventilator & nasal interface.~Noninvasive Open Ventilation System: Noninvasive ventilation system"
261357|NCT01355705|B1|Baseline|Amrubicin + Lenalidomide + Dexamethasone|"Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.~Concurrent therapeutic medications:~Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14~Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)~Other drugs:~Aspirin: 81 or 325 mg daily oral~Pegfilgrastim subcutaneous on Day 2"
261358|NCT01355705|P1|Participant Flow|Amrubicin + Lenalidomide + Dexamethasone|"Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.~Concurrent therapeutic medications:~Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14~Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)~Other drugs:~Aspirin: 81 or 325 mg daily oral~Pegfilgrastim subcutaneous on Day 2"
261359|NCT01355705|O1|Outcome|Amrubicin + Lenalidomide + Dexamethasone|"Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.~Concurrent therapeutic medications:~Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14~Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)~Other drugs:~Aspirin: 81 or 325 mg daily oral~Pegfilgrastim subcutaneous on Day 2"
261360|NCT01355705|O1|Outcome|Amrubicin + Lenalidomide + Dexamethasone|"Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.~Concurrent therapeutic medications:~Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14~Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)~Other drugs:~Aspirin: 81 or 325 mg daily oral~Pegfilgrastim subcutaneous on Day 2"
261361|NCT01355705|O1|Outcome|Amrubicin + Lenalidomide + Dexamethasone|"Amrubicin will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.~Concurrent therapeutic medications:~Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14~Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)~Other drugs:~Aspirin: 81 or 325 mg daily oral~Pegfilgrastim subcutaneous on Day 2~Amrubicin: 40, 60, or 80 mg/m2 intravenous (IV)~Lenalidomide: 15 mg daily by mouth~Dexamethasone: 40 mg weekly by mouth~Aspirin: 81 or 325 mg daily by mouth~Pegfilgrastim: 6 mg subcutaneous on Day 2"
261362|NCT01355705|O1|Outcome|Amrubicin + Lenalidomide + Dexamethasone|"Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.~Concurrent therapeutic medications:~Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14~Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)~Other drugs:~Aspirin: 81 or 325 mg daily oral~Pegfilgrastim subcutaneous on Day 2"
261363|NCT01355705|E1|Reported Event|Amrubicin + Lenalidomide + Dexamethasone|"Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.~Concurrent therapeutic medications:~Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14~Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)~Other drugs:~Aspirin: 81 or 325 mg daily oral~Pegfilgrastim subcutaneous on Day 2"
261364|NCT01355679|B1|Baseline|Guided Therapy|All subjects receive guided therapy in therapeutic combination (up to 4 agents) provided it includes medications contained in the study report.
261365|NCT01355679|P1|Participant Flow|Guided Therapy|"A total of 14 neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).~Guided Therapy: A total of 14 neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for disease response, progression and safety. All patients will be"
261366|NCT01355679|O1|Outcome|Guided Therapy|A total of 14 eligible neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).
261367|NCT01355679|O1|Outcome|Guided Therapy|A total of 14 eligible neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).
261368|NCT01355679|O1|Outcome|Guided Therapy|A total of 14 eligible neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).
261369|NCT01355679|O1|Outcome|Guided Therapy|All subjects receive guided therapy in therapeutic combination (up to 4 agents) provided it includes medications contained in the study report.
261370|NCT01355679|E1|Reported Event|Guided Therapy|A total of 14 eligible neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).
261371|NCT01355627|B3|Baseline|Total|Total of all reporting groups
261372|NCT01355627|B2|Baseline|Current Practice Group|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
261373|NCT01355627|B1|Baseline|TachoSil®|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
261374|NCT01355627|P2|Participant Flow|Current Practice Group|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
261375|NCT01355627|P1|Participant Flow|TachoSil®|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
261376|NCT01355627|O2|Outcome|Current Practice Group|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
261377|NCT01355627|O1|Outcome|TachoSil®|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
261378|NCT01355627|O2|Outcome|Current Practice Group|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
261379|NCT01355627|O1|Outcome|TachoSil®|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
261380|NCT01355627|E2|Reported Event|Current Practice Group|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
261381|NCT01355627|E1|Reported Event|TachoSil®|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
261382|NCT01355588|B5|Baseline|Total|Total of all reporting groups
261383|NCT01355588|B4|Baseline|Treatment D, Treatment A, Treatment B, Treatment C|Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
261417|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
261384|NCT01355588|B3|Baseline|Treatment C, Treatment B, Treatment A, Treatment D|Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
261385|NCT01355588|B2|Baseline|Treatment B, Treatment D, Treatment C, Treatment A|Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
261386|NCT01355588|B1|Baseline|Treatment A, Treatment C, Treatment D, Treatment B|Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
261387|NCT01355588|P4|Participant Flow|Treatment D, Treatment A, Treatment B, Treatment C|Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
261388|NCT01355588|P3|Participant Flow|Treatment C, Treatment B, Treatment A, Treatment D|Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
261389|NCT01355588|P2|Participant Flow|Treatment B, Treatment D, Treatment C, Treatment A|Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
261390|NCT01355588|P1|Participant Flow|Treatment A, Treatment C, Treatment D, Treatment B|Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
261391|NCT01355588|O4|Outcome|Ketorolac Tromethamine With 6% Lidocaine HCl|30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
261392|NCT01355588|O3|Outcome|Ketorolac Tromethamine With 5% Lidocaine HCl|Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
261393|NCT01355588|O2|Outcome|Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)|Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
261394|NCT01355588|O1|Outcome|Ketorolac Tromethamine|Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
261395|NCT01355588|O4|Outcome|Ketorolac Tromethamine With 6% Lidocaine HCl|30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
261396|NCT01355588|O3|Outcome|Ketorolac Tromethamine With 5% Lidocaine HCl|Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
261397|NCT01355588|O2|Outcome|Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)|Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
261398|NCT01355588|O1|Outcome|Ketorolac Tromethamine|Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
261399|NCT01355588|O4|Outcome|Ketorolac Tromethamine With 6% Lidocaine HCl|30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
261400|NCT01355588|O3|Outcome|Ketorolac Tromethamine With 5% Lidocaine HCl|Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
261401|NCT01355588|O2|Outcome|Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)|Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
261402|NCT01355588|O1|Outcome|Ketorolac Tromethamine|Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
261403|NCT01355588|O4|Outcome|Ketorolac Tromethamine With 6% Lidocaine HCl|30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
261404|NCT01355588|O3|Outcome|Ketorolac Tromethamine With 5% Lidocaine HCl|Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
261405|NCT01355588|O2|Outcome|Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)|Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
261406|NCT01355588|O1|Outcome|Ketorolac Tromethamine|Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
261407|NCT01355588|E4|Reported Event|Ketorolac Tromethamine With 6% Lidocaine HCl|30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
261408|NCT01355588|E3|Reported Event|Ketorolac Tromethamine With 5% Lidocaine HCl|Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
261409|NCT01355588|E2|Reported Event|Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)|Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
261410|NCT01355588|E1|Reported Event|Ketorolac Tromethamine|Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
261457|NCT01355484|B2|Baseline|Placebo|"subject will receive placebo for the duration of the trial~placebo: subject will receive placebo for the duration of the trial"
261458|NCT01355484|B1|Baseline|GTx-024|"subject will receive GTx-024 treatment for the duration of the trial~GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial."
261459|NCT01355484|P2|Participant Flow|Placebo|"subject will receive placebo for the duration of the trial~placebo: subject will receive placebo for the duration of the trial"
261460|NCT01355484|P1|Participant Flow|GTx-024|"subject will receive GTx-024 treatment for the duration of the trial~GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial."
261461|NCT01355484|O2|Outcome|Placebo|"subject will receive placebo for the duration of the trial~placebo: subject will receive placebo for the duration of the trial"
261462|NCT01355484|O1|Outcome|GTx-024|"subject will receive GTx-024 treatment for the duration of the trial~GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial."
261463|NCT01355484|O2|Outcome|Placebo|"subject will receive placebo for the duration of the trial~placebo: subject will receive placebo for the duration of the trial"
261464|NCT01355484|O1|Outcome|GTx-024|"subject will receive GTx-024 treatment for the duration of the trial~GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial."
261465|NCT01355484|E2|Reported Event|Placebo|"subject will receive placebo for the duration of the trial~placebo: subject will receive placebo for the duration of the trial"
261466|NCT01355484|E1|Reported Event|GTx-024|"subject will receive GTx-024 treatment for the duration of the trial~GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial."
261467|NCT01355471|B3|Baseline|Total|Total of all reporting groups
261468|NCT01355471|B2|Baseline|Placebo|
261469|NCT01355471|B1|Baseline|CD07805/47 Gel|
261470|NCT01355471|P2|Participant Flow|Placebo|
261471|NCT01355471|P1|Participant Flow|CD07805/47 Gel|
261472|NCT01355471|O2|Outcome|Placebo|
261473|NCT01355471|O1|Outcome|CD07805/47 Gel|
261474|NCT01355471|E2|Reported Event|Placebo|
261475|NCT01355471|E1|Reported Event|CD07805/47 Gel|
261476|NCT01355458|B3|Baseline|Total|Total of all reporting groups
261477|NCT01355458|B2|Baseline|Placebo|
261478|NCT01355458|B1|Baseline|CD07805/47 Gel|
261479|NCT01355458|P2|Participant Flow|Placebo|
261480|NCT01355458|P1|Participant Flow|CD07805/47 Gel|
261481|NCT01355458|O2|Outcome|Placebo|
261482|NCT01355458|O1|Outcome|CD07805/47 Gel|
261483|NCT01355458|E2|Reported Event|Placebo|
261484|NCT01355458|E1|Reported Event|CD07805/47 Gel|
261485|NCT01355419|B1|Baseline|Obstructive Sleep Apnea, CPAP|moderate to severe obstructive sleep apnea requiring CPAP therapy
261486|NCT01355419|P1|Participant Flow|Obstructive Sleep Apnea, CPAP|moderate to severe obstructive sleep apnea requiring CPAP therapy
261487|NCT01355419|O1|Outcome|Obstructive Sleep Apnea, CPAP|moderate to severe obstructive sleep apnea requiring CPAP therapy
261488|NCT01355419|O1|Outcome|Obstructive Sleep Apnea, CPAP|moderate to severe obstructive sleep apnea requiring CPAP therapy
261489|NCT01355419|E1|Reported Event|Obstructive Sleep Apnea, CPAP|moderate to severe obstructive sleep apnea requiring CPAP therapy
261490|NCT01355302|B1|Baseline|Phase 1b: Golvatinib+Capecitabine+Cisplatin|Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by intravenous (IV) infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a dose-limiting toxicity (DLT) in the first 3 participants.
261491|NCT01355302|P3|Participant Flow|Phase 2: Capecitabine + Cisplatin|Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by intravenous (IV) infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes.
261492|NCT01355302|P2|Participant Flow|Phase 2: Golvatinib+Capecitabine+Cisplatin|"The dose of golvatinib was to be the maximum tolerated dose (MTD) as determined during the Phase 1b portion of the study in combination with capecitabine and cisplatin as described for Phase 1b.~The study was terminated prior to Phase 2."
261493|NCT01355302|P1|Participant Flow|Phase 1b: Golvatinib+Capecitabine+Cisplatin|Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by intravenous (IV) infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a dose-limiting toxicity (DLT) in the first 3 participants.
261494|NCT01355302|O2|Outcome|Phase 2: Capecitabine + Cisplatin|"The dose of golvatinib was to be the MTD as determined during the Phase 1b portion of the study in combination with capecitabine and cisplatin as described for Phase 1b.~The study was terminated prior to Phase 2."
261495|NCT01355302|O1|Outcome|Phase 2: Golvatinib+Capecitabine+Cisplatin|"The dose of golvatinib was to be the MTD as determined during the Phase 1b portion of the study in combination with capecitabine and cisplatin as described for Phase 1b.~The study was terminated prior to Phase 2."
261496|NCT01355302|O2|Outcome|Phase 2: Capecitabine + Cisplatin|"The dose of golvatinib was to be the MTD as determined during the Phase 1b portion of the study in combination with capecitabine and cisplatin as described for Phase 1b.~The study was terminated prior to Phase 2."
261497|NCT01355302|O1|Outcome|Phase 2: Golvatinib+Capecitabine+Cisplatin|"The dose of golvatinib was to be the maximum tolerated dose (MTD) as determined during the Phase 1b portion of the study in combination with capecitabine and cisplatin as described for Phase 1b.~The study was terminated prior to Phase 2."
261498|NCT01355302|O1|Outcome|Phase 1b: Golvatinib+Capecitabine+Cisplatin|Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by IV infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a DLT in the first 3 participants.
261499|NCT01355302|O1|Outcome|Phase 1b: Golvatinib+Capecitabine+Cisplatin|Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by IV infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a DLT in the first 3 participants.
261500|NCT01355302|O1|Outcome|Phase 1b: Golvatinib+Capecitabine+Cisplatin|Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by IV infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a DLT in the first 3 participants.
261501|NCT01355302|O1|Outcome|Phase 1b: Golvatinib+Capecitabine+Cisplatin|Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by intravenous (IV) infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a dose-limiting toxicity (DLT) in the first 3 participants.
261502|NCT01355302|E1|Reported Event|Phase 1b: Golvatinib+Capecitabine+Cisplatin|Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by intravenous (IV) infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a dose-limiting toxicity (DLT) in the first 3 participants.
261503|NCT01355289|B5|Baseline|Total|Total of all reporting groups
261504|NCT01355289|B4|Baseline|Avatrombopag 30 mg (Core Study)|Avatrombopag 30 mg, was administered orally, once daily, preferably with food for up to 21 days.
261505|NCT01355289|B3|Baseline|Avatrombopag 20 mg (Core Study)|Avatrombopag 20 mg, was administered orally, once daily, preferably with food for up to 21 days.
261506|NCT01355289|B2|Baseline|Avatrombopag 10 mg (Core Study)|Avatrombopag 10 mg, was administered orally, once daily, preferably with food for up to 21 days.
261507|NCT01355289|B1|Baseline|Placebo (Core Study)|Placebo, was given orally for upto 21 days once daily.
261508|NCT01355289|P5|Participant Flow|Avatrombopag (Open Label Extension)|Avatrombopag was initiated at a dose of 20 mg, once daily in the open label extension (OLE) period. The avatrombopag dose was titrated up or down in accordance with their individual response within the range of a minimum of 5 mg and a maximum of 50 mg for up to 48 weeks.
261509|NCT01355289|P4|Participant Flow|Avatrombopag 30 mg (Core Study)|Avatrombopag 30 mg, was administered orally, once daily, preferably with food for up to 21 days.
261510|NCT01355289|P3|Participant Flow|Avatrombopag 20 mg (Core Study)|Avatrombopag 20 mg, was administered orally, once daily, preferably with food for up to 21 days.
261511|NCT01355289|P2|Participant Flow|Avatrombopag 10 mg (Core Study)|Avatrombopag 10 mg, was administered orally, once daily, preferably with food for up to 21 days.
261512|NCT01355289|P1|Participant Flow|Placebo (Core Study)|Placebo, was given orally for up to 21 days once daily.
261513|NCT01355289|O4|Outcome|Avatrombopag 30 mg (Core Study)|Avatrombopag 30 mg, was administered orally, once daily, preferably with food for up to 21 days.
261514|NCT01355289|O3|Outcome|Avatrombopag 20 mg (Core Study)|Avatrombopag 20 mg, was administered orally, once daily, preferably with food for up to 21 days.
261515|NCT01355289|O2|Outcome|Avatrombopag 10 mg (Core Study)|Avatrombopag 10 mg, was administered orally, once daily, preferably with food for up to 21 days.
261517|NCT01355289|O4|Outcome|Avatrombopag 30 mg (Core Study)|Avatrombopag 30 mg, was administered orally, once daily, preferably with food for up to 21 days.
261518|NCT01355289|O3|Outcome|Avatrombopag 20 mg (Core Study)|Avatrombopag 20 mg, was administered orally, once daily, preferably with food for up to 21 days.
261519|NCT01355289|O2|Outcome|Avatrombopag 10 mg (Core Study)|Avatrombopag 10 mg, was administered orally, once daily, preferably with food for up to 21 days.
261520|NCT01355289|O1|Outcome|Placebo (Core Study)|Placebo, was given orally for up to 21 days once daily.
261521|NCT01355289|O4|Outcome|Avatrombopag 30 mg (Core Study)|Avatrombopag 30 mg, was administered orally, once daily, preferably with food for up to 21 days.
261522|NCT01355289|O3|Outcome|Avatrombopag 20 mg (Core Study)|Avatrombopag 20 mg, was administered orally, once daily, preferably with food for up to 21 days.
261523|NCT01355289|O2|Outcome|Avatrombopag 10 mg (Core Study)|Avatrombopag 10 mg, was administered orally, once daily, preferably with food for up to 21 days.
261524|NCT01355289|O1|Outcome|Placebo (Core Study)|Placebo, was given orally for up to 21 days once daily.
261525|NCT01355289|O4|Outcome|Avatrombopag 30 mg (Core Study)|Avatrombopag 30 mg, was administered orally, once daily, preferably with food for up to 21 days
261526|NCT01355289|O3|Outcome|Avatrombopag 20 mg (Core Study)|Avatrombopag 20 mg, was administered orally, once daily, preferably with food for up to 21 days
261527|NCT01355289|O2|Outcome|Avatrombopag 10 mg (Core Study)|Avatrombopag 10 mg, was administered orally, once daily, preferably with food for up to 21 days.
261528|NCT01355289|O1|Outcome|Placebo (Core Study)|Placebo, was given orally for up to 21 days once daily.
261529|NCT01355289|E5|Reported Event|Avatrombopag (Open Label Extension)|Avatrombopag was initiated at a dose of 20 mg, once daily in the open label extension (OLE) period. The avatrombopag dose was titrated up or down in accordance with their individual response within the range of a minimum of 5 mg and a maximum of 50 mg for up to 48 weeks.
261530|NCT01355289|E4|Reported Event|Avatrombopag 30 mg (Core Study)|Avatrombopag 30 mg, was administered orally, once daily, preferably with food for up to 21 days.
261531|NCT01355289|E3|Reported Event|Avatrombopag 20 mg (Core Study)|Avatrombopag 20 mg, was administered orally, once daily, preferably with food for up to 21 days.
261532|NCT01355289|E2|Reported Event|Avatrombopag 10 mg (Core Study)|Avatrombopag 10 mg, was administered orally, once daily, preferably with food for up to 21 days.
261533|NCT01355289|E1|Reported Event|Placebo (Core Study)|Placebo, was given orally for up to 21 days once daily.
261534|NCT01355224|B5|Baseline|Total|Total of all reporting groups
261535|NCT01355224|B4|Baseline|Both Genetic and Lifestyle Risk Feedback|"FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.~Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV)."
261536|NCT01355224|B3|Baseline|Lifestyle Risk Feedback|Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV).
261537|NCT01355224|B2|Baseline|Genetic Risk Feedback|FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.
261538|NCT01355224|B1|Baseline|No Risk Feedback|No risk feedback for obesity was provided.
261539|NCT01355224|P4|Participant Flow|Both Genetic and Lifestyle Risk Feedback|"FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.~Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV)."
261540|NCT01355224|P3|Participant Flow|Lifestyle Risk Feedback|Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV).
261541|NCT01355224|P2|Participant Flow|Genetic Risk Feedback|FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.
261542|NCT01355224|P1|Participant Flow|No Risk Feedback|No risk feedback for obesity was provided.
261543|NCT01355224|O5|Outcome|High Genetic Risk + High Lifestyle Risk Feedback|Feedback received: Had elevated risk for obesity based on FTO; Had elevated risk for obesity based on lifestyle behavior.
261544|NCT01355224|O4|Outcome|High Genetic Risk + Low Lifestyle Risk Feedback|Feedback received: Had elevated risk for obesity based on FTO; did not have elevated risk for obesity based on lifestyle behavior.
261545|NCT01355224|O3|Outcome|Low Genetic Risk + High Lifestyle Risk Feedback|Feedback received: Did not have elevated risk for obesity based on FTO; had elevated risk for obesity based on lifestyle behavior.
261546|NCT01355224|O2|Outcome|Low Genetic Risk + Low Lifestyle Risk Feedback|Feedback received: Did not have elevated risk for obesity based on FTO; did not have elevated risk for obesity based on lifestyle behavior.
261547|NCT01355224|O1|Outcome|No Risk Feedback|Control - no obesity risk feedback provided.
261548|NCT01355224|O5|Outcome|High Lifestyle Risk Feedback|Lifestyle feedback arm; had elevated risk for obesity based on lifestyle behavior alone.
261549|NCT01355224|O4|Outcome|Low Lifestyle Risk Feedback|Lifestyle feedback arm; did not have elevated risk for obesity based on lifestyle behavior alone.
261550|NCT01355224|O3|Outcome|High Genetic Risk Feedback|Genetic feedback arm; had elevated risk for obesity based on FTO alone.
261551|NCT01355224|O2|Outcome|Low Genetic Risk Feedback|Genetic feedback arm; did not have elevated risk for obesity based on FTO alone.
261552|NCT01355224|O1|Outcome|No Risk Feedback|Control - no obesity risk feedback provided.
261553|NCT01355224|O4|Outcome|Genetic and Lifestyle Risk Feedback|"FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.~Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV)."
261554|NCT01355224|O3|Outcome|Lifestyle Risk Feedback|Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV).
261555|NCT01355224|O2|Outcome|Genetic Risk Feedback|FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.
261556|NCT01355224|O1|Outcome|No Risk Feedback|Control - no obesity risk feedback provided.
263271|NCT01350115|O2|Outcome|Placebo|Participants received matching placebo.
261557|NCT01355224|E4|Reported Event|Both Genetic and Lifestyle Risk Feedback|"FTO variant: Relative risk estimates will be presented based on individuals'risk for obesity based on genotype results.~Lifestyle: Relative risk estimates will be presented based on individuals' risk for obesity due to lifestyle factors."
261558|NCT01355224|E3|Reported Event|Lifestyle Risk Feedback|Lifestyle: Relative risk estimates will be presented based on individuals' risk for obesity due to lifestyle factors.
261559|NCT01355224|E2|Reported Event|Genetic Risk Feedback|FTO variant: Relative risk estimates will be presented based on individuals'risk for obesity based on genotype results.
261560|NCT01355224|E1|Reported Event|No Risk Feedback|Control arm - no obesity risk feedback provided
261561|NCT01355081|B4|Baseline|Total|Total of all reporting groups
261562|NCT01355081|B3|Baseline|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
261563|NCT01355081|B2|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
261564|NCT01355081|B1|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
261565|NCT01355081|P3|Participant Flow|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
261566|NCT01355081|P2|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
261567|NCT01355081|P1|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
261568|NCT01355081|O3|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
261569|NCT01355081|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
261570|NCT01355081|O1|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
261571|NCT01355081|O3|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
261572|NCT01355081|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
261573|NCT01355081|O1|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
261574|NCT01355081|O3|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
261575|NCT01355081|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
261576|NCT01355081|O1|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
261577|NCT01355081|O3|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
261578|NCT01355081|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
261579|NCT01355081|O1|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
261580|NCT01355081|O3|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
261581|NCT01355081|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
261582|NCT01355081|O1|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
261583|NCT01355081|O3|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
261584|NCT01355081|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
261585|NCT01355081|O1|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
261586|NCT01355081|E3|Reported Event|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
261587|NCT01355081|E2|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
261588|NCT01355081|E1|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
261589|NCT01355068|B1|Baseline|Entire Study Population|Includes participants randomized to receive Epanutin (phenytoin) infatabs 50 mg first and Dilantin (phenytoin) infatabs 50 mg first.
261590|NCT01355068|P2|Participant Flow|Dilantin Infatabs 50 mg First, Then Epanutin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet in first intervention period; and single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet in second intervention period. A washout period of at least 7 days was maintained between each period.
261591|NCT01355068|P1|Participant Flow|Epanutin Infatabs 50 mg First, Then Dilantin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 milligram (mg) chewable tablet in first intervention period; and single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet in second intervention period. A washout period of at least 7 days was maintained between each period.
261592|NCT01355068|O2|Outcome|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
261593|NCT01355068|O1|Outcome|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
261594|NCT01355068|O2|Outcome|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
261595|NCT01355068|O1|Outcome|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
261596|NCT01355068|O2|Outcome|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
261597|NCT01355068|O1|Outcome|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
261598|NCT01355068|O2|Outcome|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
261599|NCT01355068|O1|Outcome|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
261600|NCT01355068|O2|Outcome|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
282604|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
261601|NCT01355068|O1|Outcome|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
261602|NCT01355068|O2|Outcome|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
261603|NCT01355068|O1|Outcome|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
261604|NCT01355068|E2|Reported Event|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
261605|NCT01355068|E1|Reported Event|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
261606|NCT01354990|B1|Baseline|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
261607|NCT01354990|P1|Participant Flow|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
261608|NCT01354990|O1|Outcome|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
261609|NCT01354990|O1|Outcome|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
261610|NCT01354990|O1|Outcome|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
261611|NCT01354990|O1|Outcome|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
261612|NCT01354990|E1|Reported Event|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
261613|NCT01354938|B1|Baseline|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
261614|NCT01354938|P1|Participant Flow|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
261615|NCT01354938|O1|Outcome|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
261616|NCT01354938|O1|Outcome|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
261617|NCT01354938|O1|Outcome|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
261618|NCT01354938|E1|Reported Event|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
261619|NCT01354899|B1|Baseline|Window|"WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.~Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer."
261620|NCT01354899|P1|Participant Flow|Window|"WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.~Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer."
261621|NCT01354899|O1|Outcome|Window|"WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.~Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer."
261622|NCT01354899|O1|Outcome|Window|"WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.~Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer."
261623|NCT01354899|E1|Reported Event|Window|"WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.~Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer."
261624|NCT01354652|B4|Baseline|Total|Total of all reporting groups
261625|NCT01354652|B3|Baseline|no NRTI Group|hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
261626|NCT01354652|B2|Baseline|Lamivudine|"Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
261627|NCT01354652|B1|Baseline|Entecavir|"Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
261628|NCT01354652|P3|Participant Flow|no NRTI Group|hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
261629|NCT01354652|P2|Participant Flow|Lamivudine|"Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
261630|NCT01354652|P1|Participant Flow|Entecavir|"Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
261631|NCT01354652|O3|Outcome|no NRTI Group|hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
261632|NCT01354652|O2|Outcome|Lamivudine|"Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
261633|NCT01354652|O1|Outcome|Entecavir|"Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
261634|NCT01354652|O3|Outcome|no NRTI Group|hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
261635|NCT01354652|O2|Outcome|Lamivudine|"Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
261678|NCT01354431|O3|Outcome|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
261679|NCT01354431|O2|Outcome|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
261680|NCT01354431|O1|Outcome|0.3 mg/kg Nivolumab|Nivolumab Solution, Intravenous (IV), 0.3 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
261681|NCT01354431|O3|Outcome|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
261636|NCT01354652|O1|Outcome|Entecavir|"Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
261637|NCT01354652|O3|Outcome|no NRTI Group|hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
261638|NCT01354652|O2|Outcome|Lamivudine|"Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
261639|NCT01354652|O1|Outcome|Entecavir|"Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
261640|NCT01354652|O3|Outcome|no NRTI Group|hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
261641|NCT01354652|O2|Outcome|Lamivudine|"Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
261642|NCT01354652|O1|Outcome|Entecavir|"Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
261643|NCT01354652|O3|Outcome|no NRTI Group|hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
261644|NCT01354652|O2|Outcome|Lamivudine|"Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
261645|NCT01354652|O1|Outcome|Entecavir|"Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
261646|NCT01354652|O3|Outcome|no NRTI Group|hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
261647|NCT01354652|O2|Outcome|Lamivudine|"Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
261682|NCT01354431|O2|Outcome|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
261683|NCT01354431|O1|Outcome|0.3 mg/kg Nivolumab|Nivolumab Solution, Intravenous (IV), 0.3 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
261684|NCT01354431|O3|Outcome|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons.
261685|NCT01354431|O2|Outcome|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons.
261648|NCT01354652|O1|Outcome|Entecavir|"Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
261649|NCT01354652|E3|Reported Event|no NRTI Group|hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
261650|NCT01354652|E2|Reported Event|Lamivudine|"Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
261651|NCT01354652|E1|Reported Event|Entecavir|"Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
261652|NCT01354444|B3|Baseline|Total|Total of all reporting groups
261653|NCT01354444|B2|Baseline|Placebo|"Non active substance~Placebo: a pill that will look like the active drug but will not contain any carvedilol"
261654|NCT01354444|B1|Baseline|Carvedilol|"Carvedilol is a is a beta-blocker. Beta-blockers are generally used to reduce the workload on the heart and help it to beat more regularly.~Carvedilol: target dose of 25 mg daily which is half the maximum dose used in clinical practice"
261655|NCT01354444|P2|Participant Flow|Placebo|"Non active substance~Placebo: a pill that will look like the active drug but will not contain any carvedilol"
261656|NCT01354444|P1|Participant Flow|Carvedilol|"Carvedilol is a is a beta-blocker. Beta-blockers are generally used to reduce the workload on the heart and help it to beat more regularly.~Carvedilol: target dose of 25 mg daily which is half the maximum dose used in clinical practice"
261657|NCT01354444|O2|Outcome|Placebo|"Non active substance~Placebo: a pill that will look like the active drug but will not contain any carvedilol"
261658|NCT01354444|O1|Outcome|Carvedilol|"Carvedilol is a is a beta-blocker. Beta-blockers are generally used to reduce the workload on the heart and help it to beat more regularly.~Carvedilol: target dose of 25 mg daily which is half the maximum dose used in clinical practice"
261659|NCT01354444|O2|Outcome|Placebo|"Non active substance~Placebo: a pill that will look like the active drug but will not contain any carvedilol"
261660|NCT01354444|O1|Outcome|Carvedilol|"Carvedilol is a is a beta-blocker. Beta-blockers are generally used to reduce the workload on the heart and help it to beat more regularly.~Carvedilol: target dose of 25 mg daily which is half the maximum dose used in clinical practice"
261661|NCT01354444|O2|Outcome|HVLT Score in Treatment Group|Descriptive statistics for immediate recall in the Hopkins Verbal Learning Test in the treatment group
261662|NCT01354444|O1|Outcome|HVLT Score in Placebo Group|Descriptive statistics for immediate recall in the Hopkins Verbal Learning Test in the placebo group
261663|NCT01354444|E2|Reported Event|Placebo|"Non active substance~Placebo: a pill that will look like the active drug but will not contain any carvedilol"
261664|NCT01354444|E1|Reported Event|Carvedilol|"Carvedilol is a is a beta-blocker. Beta-blockers are generally used to reduce the workload on the heart and help it to beat more regularly.~Carvedilol: target dose of 25 mg daily which is half the maximum dose used in clinical practice"
261665|NCT01354431|B4|Baseline|Total|Total of all reporting groups
261666|NCT01354431|B3|Baseline|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
261667|NCT01354431|B2|Baseline|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
261668|NCT01354431|B1|Baseline|0.3 mg/kg Nivolumab|Nivolumab Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (q 3 weeks), until Progressive disease (PD), toxicity or discontinued for other reasons
261669|NCT01354431|P3|Participant Flow|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
261670|NCT01354431|P2|Participant Flow|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinued for other reasons
261671|NCT01354431|P1|Participant Flow|0.3 mg/kg Nivolumab|Nivolumab Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinued for other reasons
261672|NCT01354431|O3|Outcome|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
261673|NCT01354431|O2|Outcome|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
261674|NCT01354431|O1|Outcome|0.3 mg/kg Nivolumab|Nivolumab Solution, IV, 0.3 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
261675|NCT01354431|O3|Outcome|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
261676|NCT01354431|O2|Outcome|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
261677|NCT01354431|O1|Outcome|0.3 mg/kg Nivolumab|Nivolumab Solution, IV, 0.3 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
261686|NCT01354431|O1|Outcome|0.3 mg/kg Nivolumab|Nivolumab Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (q 3 weeks), until progressive disease (PD), toxicity or discontinued for other reasons.
261687|NCT01354431|E3|Reported Event|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons.
261688|NCT01354431|E2|Reported Event|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons.
261689|NCT01354431|E1|Reported Event|0.3 mg/kg Nivolumab|Nivolumab Solution, IV, 0.3 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons.
261690|NCT01354314|B5|Baseline|Total|Total of all reporting groups
261691|NCT01354314|B4|Baseline|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261692|NCT01354314|B3|Baseline|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261693|NCT01354314|B2|Baseline|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261694|NCT01354314|B1|Baseline|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261695|NCT01354314|P4|Participant Flow|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261696|NCT01354314|P3|Participant Flow|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261697|NCT01354314|P2|Participant Flow|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261698|NCT01354314|P1|Participant Flow|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261699|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261700|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261701|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261702|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261703|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261704|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261705|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261706|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261707|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261708|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261709|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261710|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261711|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261712|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261713|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261714|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261715|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261716|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261717|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261718|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261719|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261720|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261721|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261722|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261723|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261724|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261725|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261726|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261727|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261728|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261729|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261730|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261731|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261732|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261733|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261734|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261735|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261736|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261737|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261738|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261739|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261740|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261741|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261742|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261743|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261744|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261745|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261746|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261747|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261748|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261749|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261750|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261751|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261752|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261753|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261754|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261755|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261756|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261757|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261758|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261759|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261760|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261761|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261762|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261763|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261764|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261765|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261766|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261767|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261768|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261769|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261770|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261771|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261772|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261773|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261774|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261775|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261776|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261777|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261842|NCT01354223|O2|Outcome|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
261778|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261779|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261780|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261781|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261782|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261783|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261784|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261785|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261786|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261787|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261788|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261789|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261790|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261791|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261792|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261793|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261794|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261795|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261796|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261797|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261798|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261799|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261800|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261801|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261802|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261803|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261804|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261805|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261806|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261807|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261808|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261809|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261810|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261811|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261812|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261813|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261814|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261815|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261816|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261817|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261818|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261819|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261820|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261821|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261822|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261823|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261824|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261825|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261826|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261827|NCT01354314|E4|Reported Event|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
261828|NCT01354314|E3|Reported Event|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
261829|NCT01354314|E2|Reported Event|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
261830|NCT01354314|E1|Reported Event|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
261831|NCT01354223|B3|Baseline|Total|Total of all reporting groups
261832|NCT01354223|B2|Baseline|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
261833|NCT01354223|B1|Baseline|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
261834|NCT01354223|P2|Participant Flow|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
261835|NCT01354223|P1|Participant Flow|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
261836|NCT01354223|O2|Outcome|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
261837|NCT01354223|O1|Outcome|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
261838|NCT01354223|O2|Outcome|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
261839|NCT01354223|O1|Outcome|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
261840|NCT01354223|O2|Outcome|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
261841|NCT01354223|O1|Outcome|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
261944|NCT01354028|O1|Outcome|Heart Rate During Massage|Heart rate during massage therapy
261843|NCT01354223|O1|Outcome|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
261844|NCT01354223|O2|Outcome|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
261845|NCT01354223|O1|Outcome|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
261846|NCT01354223|E2|Reported Event|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
261847|NCT01354223|E1|Reported Event|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
261848|NCT01354197|B3|Baseline|Total|Total of all reporting groups
261849|NCT01354197|B2|Baseline|Non-survive at Day 28|The patients who non-survived at 28 days after surgical ICU admission.
261850|NCT01354197|B1|Baseline|Survive at Day 28|The patients who survived at 28 days after surgical ICU admission.
261851|NCT01354197|P1|Participant Flow|All ICU Admission Patients|All ICU admission to surgical intensive care unit at cohort time
261852|NCT01354197|O1|Outcome|All ICU Admission Patients|All ICU admission to surgical intensive care unit at cohort time
261853|NCT01354197|O1|Outcome|All ICU Admission Patients|All ICU admission to surgical intensive care unit at cohort time
261854|NCT01354197|E2|Reported Event|Non-survive at Day 28|Number of participants who Did Not survive at day 28
261855|NCT01354197|E1|Reported Event|Survive at Day 28|Number of participants who survive at day 28
261856|NCT01354145|B3|Baseline|Total|Total of all reporting groups
261857|NCT01354145|B2|Baseline|Celecoxib|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
261858|NCT01354145|B1|Baseline|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
261859|NCT01354145|P2|Participant Flow|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
261860|NCT01354145|P1|Participant Flow|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
261861|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
261862|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
261863|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
261864|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
261865|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
261866|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
261867|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
261868|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
261869|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
261870|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
261871|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
261872|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
261873|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
261874|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
261875|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
261876|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
261877|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
261878|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
261879|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
282605|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
261880|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
261881|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
261882|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
261883|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
261884|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
261885|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
261886|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
261887|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
261888|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
261889|NCT01354145|E2|Reported Event|Celecoxib|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
261890|NCT01354145|E1|Reported Event|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
261891|NCT01354132|B3|Baseline|Total|Total of all reporting groups
261892|NCT01354132|B2|Baseline|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261893|NCT01354132|B1|Baseline|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261894|NCT01354132|P2|Participant Flow|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261895|NCT01354132|P1|Participant Flow|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261896|NCT01354132|O1|Outcome|Placebo Group|Placebo comparison group for study matching effervescent placebo tablets in water 2 in am and 1 in pm
261897|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261898|NCT01354132|O1|Outcome|Placebo Group|Placebo comparison group for study matching effervescent placebo tablets in water 2 in am and 1 in pm
261899|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261900|NCT01354132|O1|Outcome|Placebo Group|Placebo comparison group for study matching effervescent placebo tablets in water 2 in am and 1 in pm
261901|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261902|NCT01354132|O1|Outcome|Placebo Group|"Placebo comparison group for study matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261903|NCT01354132|O1|Outcome|N-acetyl-cysteine|n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM
261904|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261905|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261906|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261907|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261908|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261909|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261910|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261911|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
262081|NCT01353898|P6|Participant Flow|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
261912|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261913|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261914|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261915|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261916|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261917|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261918|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261919|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261920|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261921|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261922|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261923|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261924|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261925|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261926|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261927|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261928|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261929|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261930|NCT01354132|E2|Reported Event|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261931|NCT01354132|E1|Reported Event|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
261932|NCT01354106|B1|Baseline|Infant|Investigational adhesive tape control paper tape
261933|NCT01354106|P1|Participant Flow|Adhesive Medical Tape|"Each study participant received both treatment arms: 3M Kind Removal Silicone Tape (1 x 1.5 sample, applied one time, worn 24 hours) and 3M Micropore Silicone Tape (1 x 1.5 sample, applied one ime, worn 24 hours)."
261934|NCT01354106|O2|Outcome|3M Micropore Medical Tape|"1 x 1.5 sample applied one time, worn for 24 hours."
261935|NCT01354106|O1|Outcome|3M Kind Removal Silicone Tape|"1 x 1.5 sample applied one time, worn for 24 hours."
261936|NCT01354106|E2|Reported Event|Control Paper Tape|
261937|NCT01354106|E1|Reported Event|Investigational Adhesive Tape|
261938|NCT01354028|B1|Baseline|Massage Therapy|Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.
261939|NCT01354028|P2|Participant Flow|No Massage Therapy First Day, Massage Therapy Second Day|"Day one of study: No massage therapy. Actigraph in place to measure sleep for 3 hours.~Day two of study: Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours."
261940|NCT01354028|P1|Participant Flow|Massage Therapy First Day, no Massage Therapy Second Day|"Day one of study: Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.~Day two of study: No massage therapy. Actigraph in place to measure sleep for 3 hours"
261941|NCT01354028|O2|Outcome|No Massage Therapy|This was a crossover trial. The infants received 10 minutes of massage therapy on one day, and no massage therapy (no intervention) the other day. On the day that infants did not receive massage therapy, they were monitored as usual with heart rate and oxygen saturation levels and with the Actigraph that measured sleep efficiency, but there was no intervention.
261942|NCT01354028|O1|Outcome|Massage Therapy|Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.
261943|NCT01354028|O2|Outcome|Heart Rate Without Massage|No intervention. This is a crossover trial. Infants received massage therapy on one day and no massage (no intervention) on the other day. They continued to be monitored for heart rate, oxygen saturation, and sleep efficiency using the Actigraph on the day that they received no intervention, but at corresponding times.
261945|NCT01354028|O2|Outcome|Oxygen Saturation Without Massage|No intervention. This is a crossover trial. Infants received massage therapy on one day and no massage (no intervention) on the other day. They continued to be monitored for heart rate, oxygen saturation, and sleep efficiency using the Actigraph on the day that they received no intervention, but at corresponding times.
261946|NCT01354028|O1|Outcome|Oxygen Saturation During Massage|Oxygen saturation during massage therapy
261947|NCT01354028|O2|Outcome|Sleep Efficiency With no Massage Therapy|No intervention. This is a crossover trial. Infants received massage therapy on one day and no massage (no intervention) on the other day. They continued to be monitored for sleep efficiency using the Actigraph on the day that they received no intervention, but at corresponding times. Actigraph in place to measure sleep efficiency for 3 hours - following 9 AM feeding until approximately 12 noon.
261948|NCT01354028|O1|Outcome|Sleep Efficiency With Massage Therapy|Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep efficiency for 3 hours - following 9 AM feeding until approximately 12 noon.
261949|NCT01354028|E2|Reported Event|No Massage Therapy|This was a crossover trial. The infants received 10 minutes of massage therapy on one day, and no massage therapy (no intervention) the other day. On the day that infants did not receive massage therapy, they were monitored as usual with heart rate and oxygen saturation levels and with the Actigraph that measured sleep efficiency, but there was no intervention.
261950|NCT01354028|E1|Reported Event|Massage Therapy|Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.
261951|NCT01354015|B3|Baseline|Total|Total of all reporting groups
261952|NCT01354015|B2|Baseline|Usual Care|Usual Care
261953|NCT01354015|B1|Baseline|Use of Messaging System|"Use of DRMS~DRMS: USE OF TEXT MESSAGING SYSTEM"
261954|NCT01354015|P2|Participant Flow|Usual Care|Usual Care
261955|NCT01354015|P1|Participant Flow|Use of Messaging System|"Use of DRMS~DRMS: USE OF TEXT MESSAGING SYSTEM"
261956|NCT01354015|O2|Outcome|Usual Care|Usual Care
261957|NCT01354015|O1|Outcome|Use of Messaging System|"Use of DRMS~DRMS: USE OF TEXT MESSAGING SYSTEM"
261958|NCT01354015|O2|Outcome|Usual Care|Usual Care
261959|NCT01354015|O1|Outcome|Use of Messaging System|"Use of DRMS~DRMS: USE OF TEXT MESSAGING SYSTEM"
261960|NCT01354015|E2|Reported Event|Usual Care|Usual Care
261961|NCT01354015|E1|Reported Event|Use of Messaging System|"Use of DRMS~DRMS: USE OF TEXT MESSAGING SYSTEM"
261962|NCT01353976|B3|Baseline|Total|Total of all reporting groups
261963|NCT01353976|B2|Baseline|Vehicle Foam|Placebo medication
261964|NCT01353976|B1|Baseline|Econazole Nitrate Foam 1%|Study medication
261965|NCT01353976|P2|Participant Flow|Vehicle Foam|Placebo medication
261966|NCT01353976|P1|Participant Flow|Econazole Nitrate Foam 1%|Study medication
261967|NCT01353976|O2|Outcome|Vehicle Foam|Placebo medication
261968|NCT01353976|O1|Outcome|Econazole Nitrate Foam 1%|Study medication
261969|NCT01353976|O2|Outcome|Vehicle Foam|Placebo medication
261970|NCT01353976|O1|Outcome|Econazole Nitrate Foam 1%|Study medication
261971|NCT01353976|O2|Outcome|Vehicle Foam|Placebo medication
261972|NCT01353976|O1|Outcome|Econazole Nitrate Foam 1%|Study medication
261973|NCT01353976|E2|Reported Event|Vehicle Foam|Placebo medication
261974|NCT01353976|E1|Reported Event|Econazole Nitrate Foam 1%|Study medication
261975|NCT01353963|B1|Baseline|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
261976|NCT01353963|P1|Participant Flow|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
261977|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
261978|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
261979|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
262001|NCT01353911|P1|Participant Flow|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262128|NCT01353586|B3|Baseline|Total|Total of all reporting groups
282606|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
261980|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
261981|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
261982|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
261983|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
261984|NCT01353963|E1|Reported Event|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
261985|NCT01353911|B9|Baseline|Total|Total of all reporting groups
261986|NCT01353911|B8|Baseline|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
261987|NCT01353911|B7|Baseline|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
261988|NCT01353911|B6|Baseline|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
261989|NCT01353911|B5|Baseline|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
261990|NCT01353911|B4|Baseline|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
261991|NCT01353911|B3|Baseline|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
261992|NCT01353911|B2|Baseline|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
261993|NCT01353911|B1|Baseline|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
261994|NCT01353911|P8|Participant Flow|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
261995|NCT01353911|P7|Participant Flow|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
261996|NCT01353911|P6|Participant Flow|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
261997|NCT01353911|P5|Participant Flow|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
261998|NCT01353911|P4|Participant Flow|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
261999|NCT01353911|P3|Participant Flow|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262000|NCT01353911|P2|Participant Flow|Grazoprevir 100 mg|TN non-cirrhotic (NC) participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262002|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
262003|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262004|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262005|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262006|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262007|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262008|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262009|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262010|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
262011|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262012|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262013|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262014|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262015|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262016|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262017|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262018|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
262019|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262020|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262021|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262022|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262023|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262024|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262025|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262026|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
262080|NCT01353898|B1|Baseline|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
263272|NCT01350115|O1|Outcome|LDE225|Participants received 400 mg once daily.
262027|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262028|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262029|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262030|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262031|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262032|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262033|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262034|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
262035|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262036|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262037|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262038|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262039|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262040|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262041|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262042|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
262043|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262044|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262045|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262046|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262047|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262048|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262049|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262050|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
262051|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
263273|NCT01350115|E4|Reported Event|Placebo - Long Term Follow-up|
262052|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262053|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262054|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262055|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262056|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262057|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262058|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
262059|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262060|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262061|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262062|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262063|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262064|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262065|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262066|NCT01353911|E8|Reported Event|Non-cirr: Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
262067|NCT01353911|E7|Reported Event|Non-cirr: Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262068|NCT01353911|E6|Reported Event|Non-cirr: Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262069|NCT01353911|E5|Reported Event|Non-cirr: Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262070|NCT01353911|E4|Reported Event|Non-cirr: Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262071|NCT01353911|E3|Reported Event|Non-cirr: Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262072|NCT01353911|E2|Reported Event|Non-cirr: Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262073|NCT01353911|E1|Reported Event|Cirr: OL Grazoprevir 100 mg|TN cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
262074|NCT01353898|B7|Baseline|Total|Total of all reporting groups
262075|NCT01353898|B6|Baseline|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
262076|NCT01353898|B5|Baseline|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
262077|NCT01353898|B4|Baseline|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
262078|NCT01353898|B3|Baseline|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
262079|NCT01353898|B2|Baseline|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
262297|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262082|NCT01353898|P5|Participant Flow|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
262083|NCT01353898|P4|Participant Flow|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
262084|NCT01353898|P3|Participant Flow|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
262085|NCT01353898|P2|Participant Flow|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
262086|NCT01353898|P1|Participant Flow|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
262087|NCT01353898|O6|Outcome|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
262088|NCT01353898|O5|Outcome|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
262089|NCT01353898|O4|Outcome|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
262090|NCT01353898|O3|Outcome|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
262091|NCT01353898|O2|Outcome|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
262092|NCT01353898|O1|Outcome|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
262093|NCT01353898|O6|Outcome|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
262094|NCT01353898|O5|Outcome|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
262095|NCT01353898|O4|Outcome|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
262096|NCT01353898|O3|Outcome|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
262097|NCT01353898|O2|Outcome|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
262098|NCT01353898|O1|Outcome|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
262099|NCT01353898|O6|Outcome|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
262100|NCT01353898|O5|Outcome|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
262101|NCT01353898|O4|Outcome|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
262102|NCT01353898|O3|Outcome|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
262103|NCT01353898|O2|Outcome|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
262104|NCT01353898|O1|Outcome|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
262105|NCT01353898|E6|Reported Event|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
262106|NCT01353898|E5|Reported Event|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
262107|NCT01353898|E4|Reported Event|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
262108|NCT01353898|E3|Reported Event|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
262109|NCT01353898|E2|Reported Event|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
262110|NCT01353898|E1|Reported Event|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
262111|NCT01353859|B1|Baseline|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
262112|NCT01353859|P1|Participant Flow|Tocilizumab + Methotrexate (MTX)|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (minimum dose 480 mg, maximum dose 800 mg), intravenously (IV), once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
262113|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
262114|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
262115|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
262116|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
262117|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
262118|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
262119|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
262120|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
262121|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
262122|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
262123|NCT01353859|E1|Reported Event|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
262124|NCT01353664|B1|Baseline|ROMI 4|Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
262125|NCT01353664|P1|Participant Flow|ROMI 4|Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
262126|NCT01353664|O1|Outcome|ROMI 4|Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
262127|NCT01353664|E1|Reported Event|ROMI 4|Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
262129|NCT01353586|B2|Baseline|NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)|"Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.~These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.~Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are presented for transparency; but cannot be compared statistically against the data from the Main Study group."
262130|NCT01353586|B1|Baseline|nMARQ™ (Main Study- Single Arm)|This group of subjects underwent electrophysiological mapping and radiofrequency ablation with the Biosense Webster nMARQ™ system. The Main Study (167 subjects) consists only of subjects treated with the nMARQ catheter.
262131|NCT01353586|P2|Participant Flow|NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)|"Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.~These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.~Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are presented for transparency; but cannot be compared statistically against the data from the Main Study group."
262132|NCT01353586|P1|Participant Flow|nMARQ™ (Main Study- Single Arm)|This group of subjects underwent electrophysiological mapping and radiofrequency ablation with the Biosense Webster nMARQ™ system. The Main Study (167 subjects) consists only of subjects treated with the nMARQ catheter.
262133|NCT01353586|O2|Outcome|NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)|"Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.~These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.~Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are related for transparency; but cannot be compared statistically against the data from the Main Study group."
262134|NCT01353586|O1|Outcome|nMARQ™ System (SNA Subpopulation)|The nMARQ arm of the SNA subpopulation included 19 subjects treated with the nMARQ™ System.
262135|NCT01353586|O2|Outcome|NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)|"Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.~These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.~Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are presented for transparency; but cannot be compared statistically against the data from the Main Study group."
262136|NCT01353586|O1|Outcome|nMARQ™ System (SNA Subpopulation)|The nMARQ arm of the SNA subpopulation included 19 subjects treated with the nMARQ™ System.
262137|NCT01353586|O1|Outcome|nMARQ™ System (Main Study - Single Arm)|The Main Study group consists of subjects who were treated with the Biosense Webster nMARQ™ system. This group is single-arm and does not include the SNA substudy population (no comparator group).
262138|NCT01353586|O1|Outcome|nMARQ™ System (Main Study - Single Arm)|The Main Study group consists of subjects who were treated with the Biosense Webster nMARQ™ system. This group is single-arm and does not include the SNA substudy population (no comparator group).
262139|NCT01353586|O1|Outcome|nMARQ™ System (Main Study - Single Arm)|The Main Study group consists of subjects who were treated with the Biosense Webster nMARQ™ system. This group is single-arm and does not include the SNA substudy population (no comparator group).
262140|NCT01353586|O1|Outcome|nMARQ™ (Main Study- Single Arm)|The Main Study group consists of subjects who were treated with the Biosense Webster nMARQ™ system. This group is single-arm and does not include the SNA substudy population (no comparator group).
262141|NCT01353586|O1|Outcome|nMARQ™ (Main Study- Single Arm)|The Main Study group consists of subjects who were treated with the Biosense Webster nMARQ™ system. This group is single-arm and does not include the SNA substudy population (no comparator group).
262142|NCT01353586|O1|Outcome|nMARQ™ (Main Study- Single Arm)|The Main Study group consists of subjects who were treated with the Biosense Webster nMARQ™ system. This group is single-arm and does not include the SNA substudy population (no comparator group).
262143|NCT01353586|E2|Reported Event|NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)|"Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.~These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.~Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are presented for transparency; but cannot be compared statistically against the data from the Main Study group."
262144|NCT01353586|E1|Reported Event|nMARQ™ System (Main Study)|nMARQ™ is the Biosense Webster Pulmonary Vein Isolation System consists of Circular and Crescent Mapping and Ablation Catheters and the Multi-channel Radiofrequency Generator. This system is designed to facilitate electrophysiological mapping and transmit radiofrequency from multiple electrodes simultaneously for treating paroxysmal atrial fibrillation (PAF).
262145|NCT01353508|B5|Baseline|Total|Total of all reporting groups
262146|NCT01353508|B4|Baseline|Valsartan to LCZ696 - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
262147|NCT01353508|B3|Baseline|LCZ696 to Valsartan - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
262298|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262148|NCT01353508|B2|Baseline|Valsartan to LCZ696 - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
262149|NCT01353508|B1|Baseline|LCZ696 to Valsartan - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
262150|NCT01353508|P4|Participant Flow|Valsartan to LCZ696 - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
262151|NCT01353508|P3|Participant Flow|LCZ696 to Valsartan - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
262152|NCT01353508|P2|Participant Flow|Valsartan to LCZ696 - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
262153|NCT01353508|P1|Participant Flow|LCZ696 to Valsartan - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
262154|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
262155|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
262156|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
262157|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
262158|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
262159|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
262160|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
262161|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
262162|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
262163|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
262164|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
262165|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
262166|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
262167|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
262168|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
262169|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
262170|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
262171|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
263274|NCT01350115|E3|Reported Event|LDE225 - Long Term Follow-up|
262172|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
262173|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
262174|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
262175|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
262176|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
262177|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
262178|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
262179|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
262180|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
262181|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
262182|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
262183|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
262184|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
262185|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
262186|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
262187|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
262188|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
262189|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
262190|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
262191|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
262192|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
262193|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
262194|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
262195|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
262248|NCT01353144|B2|Baseline|Esomeprazole Plus Aspirin|"esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks~aspirin: aspirin, 100 mg, qd x 8 weeks"
262196|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
262197|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
262198|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
262199|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
262200|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
262201|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
262202|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
262203|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
262204|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
262205|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
262206|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
262207|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
262208|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
262209|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
262210|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
262211|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
262212|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
262213|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
262214|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
262215|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
262216|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
262217|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
262218|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
262219|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
262249|NCT01353144|B1|Baseline|Esomeprazole|esomeprazole (40 mg/day) for 8 weeks
263275|NCT01350115|E2|Reported Event|Placebo - Core|Participants received matching placebo.
262220|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
262221|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
262222|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
262223|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
262224|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
262225|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
262226|NCT01353508|E4|Reported Event|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
262227|NCT01353508|E3|Reported Event|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
262228|NCT01353508|E2|Reported Event|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
262229|NCT01353508|E1|Reported Event|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
262230|NCT01353274|B1|Baseline|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
262231|NCT01353274|P1|Participant Flow|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
262232|NCT01353274|O1|Outcome|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
262233|NCT01353274|O1|Outcome|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
262234|NCT01353274|O1|Outcome|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
262235|NCT01353274|O1|Outcome|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
262236|NCT01353274|O1|Outcome|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
262237|NCT01353274|E1|Reported Event|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
262238|NCT01353222|B3|Baseline|Total|Total of all reporting groups
262239|NCT01353222|B2|Baseline|Standard of Care|Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin-containing chemotherapy is beneficial in the adjuvant setting for this patient population.
262240|NCT01353222|B1|Baseline|DN24-02|DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.
262241|NCT01353222|P2|Participant Flow|Standard of Care|Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin-containing chemotherapy is beneficial in the adjuvant setting for this patient population.
262242|NCT01353222|P1|Participant Flow|DN24-02|DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.
262243|NCT01353222|O2|Outcome|Standard of Care|"Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin containing chemotherapy is beneficial in the adjuvant setting for this patient population.~Standard of Care: Standard of care"
262244|NCT01353222|O1|Outcome|DN24-02|DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.
262245|NCT01353222|E2|Reported Event|Standard of Care|Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin containing chemotherapy is beneficial in the adjuvant setting for this patient population.
262246|NCT01353222|E1|Reported Event|DN24-02|DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.
262247|NCT01353144|B3|Baseline|Total|Total of all reporting groups
263276|NCT01350115|E1|Reported Event|LDE225 - Core|Participants received 400 mg once daily.
262250|NCT01353144|P2|Participant Flow|Esomeprazole Plus Aspirin|"esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks~aspirin: aspirin, 100 mg, qd x 8 weeks"
262251|NCT01353144|P1|Participant Flow|Esomeprazole|esomeprazole (40 mg/day) for 8 weeks
262252|NCT01353144|O2|Outcome|Esomeprazole|esomeprazole (40 mg/day) for 8 weeks
262253|NCT01353144|O1|Outcome|Esomeprazole Plus Aspirin|"esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks~aspirin: aspirin, 100 mg, qd x 8 weeks"
262254|NCT01353144|O2|Outcome|Esomeprazole Plus Aspirin|"esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks~aspirin: aspirin, 100 mg, qd x 8 weeks"
262255|NCT01353144|O1|Outcome|Esomeprazole|esomeprazole (40 mg/day) for 8 weeks
262256|NCT01353144|E2|Reported Event|Esomeprazole Plus Aspirin|"esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks~aspirin: aspirin, 100 mg, qd x 8 weeks"
262257|NCT01353144|E1|Reported Event|Esomeprazole|esomeprazole (40 mg/day) for 8 weeks
262258|NCT01353079|B3|Baseline|Total|Total of all reporting groups
262259|NCT01353079|B2|Baseline|Glycero-COCAs|Placebo: Glycero-COCAS sublingual
262260|NCT01353079|B1|Baseline|Ragweed Allergenic Extract|"Allergy Immunotherapy: Daily administration of Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.~Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
262261|NCT01353079|P2|Participant Flow|Glycero-COCAs|Placebo-Glycero-COCAs sublingual
262262|NCT01353079|P1|Participant Flow|Short Ragweed Pollen Allergenic Extract|"Allergy Immunotherapy: Daily administration of Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 week prior to the ragweed pollen season.~Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
262263|NCT01353079|O2|Outcome|Placebo (Glycero-Cocas)|Placebo: Glycero-COCAs sublingual
262264|NCT01353079|O1|Outcome|Ragweed Allergenic Extract|"Allergy Immunotherapy: Daily administration of Short Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.~Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
262265|NCT01353079|O2|Outcome|Placebo (Glycero-Cocas)|Placebo: Glycero-COCAs sublingual
262266|NCT01353079|O1|Outcome|Ragweed Allergenic Extract|"Allergy Immunotherapy: Daily sublingual administration of Short Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.~Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
262267|NCT01353079|O2|Outcome|Placebo (Glycero-Cocas)|Placebo: Glycero-COCAs sublingual
262268|NCT01353079|O1|Outcome|Ragweed Allergenic Extract|"Allergy Immunotherapy: Daily sublingual administration of Short Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.~Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
262269|NCT01353079|O2|Outcome|Placebo (Glycero-Cocas)|Placebo: Glycero-COCAs sublingual
262270|NCT01353079|O1|Outcome|Ragweed Allergenic Extract|"Allergy Immunotherapy: Daily sublingual administration of ragweed allergenic extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.~Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
262271|NCT01353079|E2|Reported Event|Glycero-Cocas|placebo and short ragweed allergenic extract: Active- short ragweed allergenic extract sublingual Placebo-Glycero-Cocas sublingual
262272|NCT01353079|E1|Reported Event|Ragweed Allergenic Extract|"allergy immunotherapy: Daily administration of ragweed allergenic extract up to 42U Amb a 1 for a minimum of 8 week prior to the ragweed pollen season.~placebo and short ragweed allergenic extract: Active- short ragweed allergenic extract sublingual Placebo-Glycero-Cocas sublingual"
262273|NCT01352845|B3|Baseline|Total|Total of all reporting groups
262274|NCT01352845|B2|Baseline|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262275|NCT01352845|B1|Baseline|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262276|NCT01352845|P2|Participant Flow|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262277|NCT01352845|P1|Participant Flow|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262278|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262279|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262280|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262281|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262282|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262283|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262284|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262285|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262286|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262287|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262288|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262289|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262290|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262291|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262292|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262293|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262294|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262295|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262296|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
263277|NCT01350102|B5|Baseline|Total|Total of all reporting groups
262299|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262300|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262301|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262302|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262303|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262304|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262305|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262306|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262307|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262308|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262309|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262310|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262311|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262312|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262313|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262314|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262315|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262316|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262317|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262318|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262319|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262320|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262321|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262322|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262323|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262324|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262325|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262326|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262327|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262328|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262329|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262330|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262331|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262332|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262333|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262334|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262335|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262336|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262337|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262338|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262339|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262340|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262341|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262342|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262343|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262344|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262345|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262346|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262347|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262348|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262349|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262350|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262351|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262352|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262353|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262354|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262355|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262356|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262357|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262358|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262359|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262360|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262361|NCT01352845|E2|Reported Event|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
262362|NCT01352845|E1|Reported Event|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
262363|NCT01352793|B3|Baseline|Total|Total of all reporting groups
262364|NCT01352793|B2|Baseline|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
262365|NCT01352793|B1|Baseline|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
262366|NCT01352793|P2|Participant Flow|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
262367|NCT01352793|P1|Participant Flow|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
262368|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
262369|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
262370|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
262371|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
262372|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
262373|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
262374|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
262375|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
262376|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
262377|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
262378|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
262379|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
262380|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
262381|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
262382|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
262383|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
262384|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
262385|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
262386|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
262387|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
262388|NCT01352793|E2|Reported Event|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
262389|NCT01352793|E1|Reported Event|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
262390|NCT01352741|B1|Baseline|All Trial Participants|All participants that received at least one dose of tapentadol prolonged release at baseline, in the open-label titration period.
262391|NCT01352741|P2|Participant Flow|Tapentadol Prolonged Release and Pregabalin|At the end of the Open-label Tapentadol Titration Period participants that qualified were randomized to either tapentadol or tapentadol and pregabalin treatment. In this double-blind period participants started on Tapentadol Prolonged Release 300 mg per day (2 x 150 mg) plus Pregabalin 2 x 75 mg (total daily dose of 150 mg). A week later the dose of Pregabalin was increased to a total daily dose of 300 mg per day (2 x 150 mg), the Tapentadol Prolonged Release dose remained at 300 mg per day.
262392|NCT01352741|P1|Participant Flow|Tapentadol Prolonged Release|All participants entered the 3-week Titration Period, Tapentadol Prolonged Release was administered in an open-label fashion. Participants that did not qualify for entry into the Comparative Period were able to enter the open-label Continuation Period. During the double-blind comparator phase the dose was increased to 200 mg twice daily and after a week to 250 mg twice daily. Participants that dropped out due to tolerability issues during the comparative period were able to enter the open-label pick-up arm.
262424|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
263438|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
262393|NCT01352741|O2|Outcome|Tapentadol and Pregabalin in the Comparative Period|Tapentadol Prolonged Release 300 mg per day (2 x 150 mg) plus Pregabalin 2 x 75 mg (total daily dose of 150 mg). A week later the dose of Pregabalin was increased to a total daily dose of 300 mg per day (2 x 150 mg), the Tapentadol Prolonged Release dose remained at 300 mg per day.
262394|NCT01352741|O1|Outcome|Tapentadol in the Comparative Period|The dose of Tapentadol Prolonged Release was increased to 400 mg (2 x 200mg) and a week later to 500 mg (2 x 250 mg) per day and maintained at 500 mg per day.
262395|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period.
262396|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262397|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262398|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262399|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262400|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262401|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262402|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262403|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262404|NCT01352741|O3|Outcome|Randomization Visit (Day 22)|End of open-label titration period. Participants with 100 to 300 mg/day tapentadol.
262405|NCT01352741|O2|Outcome|Baseline Visit (Day 1)|At the end of the washout period prior to starting 100 mg/day tapentadol prolonged release.
262406|NCT01352741|O1|Outcome|Enrollment Visit (Day -12)|Participant feedback at the Enrollment Visit; on previous analgesic medication prior to study drug start.
262407|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262408|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262409|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262410|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262411|NCT01352741|O3|Outcome|Randomization Visit (Day 22)|End of open-label titration period. Participants with 100 to 300 mg/day tapentadol.
262412|NCT01352741|O2|Outcome|Baseline Visit (Day 1)|At the end of the washout period prior to starting 100 mg/day tapentadol prolonged release.
262413|NCT01352741|O1|Outcome|Enrollment Visit (Day -12)|Participant feedback at the Enrollment Visit; on previous analgesic medication prior to study drug start.
262414|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262415|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262416|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262417|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262418|NCT01352741|O3|Outcome|Randomization Visit (Day 22)|End of open-label titration period. Participants with 100 to 300 mg/day tapentadol.
262419|NCT01352741|O2|Outcome|Baseline Visit (Day 1)|At the end of the washout period prior to starting 100 mg/day tapentadol prolonged release.
262420|NCT01352741|O1|Outcome|Enrollment Visit (Day -12)|Participant feedback at the Enrollment Visit; on previous analgesic medication prior to study drug start.
262421|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262422|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262423|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262425|NCT01352741|O3|Outcome|Randomization Visit (Day 22)|End of open-label titration period. Participants with 100 to 300 mg/day tapentadol.
262426|NCT01352741|O2|Outcome|Baseline Visit (Day 1)|At the end of the washout period prior to starting 100 mg/day tapentadol prolonged release.
262427|NCT01352741|O1|Outcome|Enrollment Visit (Day -12)|Participant feedback at the Enrollment Visit; on previous analgesic medication prior to study drug start.
262428|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262429|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262430|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262431|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262432|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262433|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262434|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262435|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262436|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262437|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262438|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262439|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262440|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262441|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262442|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262443|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262444|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262445|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262446|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262447|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262448|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262449|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262450|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262451|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262452|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262621|NCT01352221|O2|Outcome|Placebo Switch to Open-label Extension ST10 Treatment|Open-label extension ST10 treatment arm for placebo subjects completing double-blind phase
262453|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262454|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262455|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262456|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration.
262457|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262458|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262459|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262460|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262461|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration.
262462|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262463|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262464|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262465|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262466|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration.
262467|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262468|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262469|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262470|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262471|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration
262472|NCT01352741|O2|Outcome|Tapentadol Prolonged Release After Tapentadol and Pregabalin|Participants that dropped-out of the Tapentadol Prolonged Release and Pregabalin in the double-blind Comparative Period continued with Tapentadol Prolonged Release at either 300 or 400 mg per day in this Open-Label Pick-up arm.
262473|NCT01352741|O1|Outcome|Tapentadol Prolonged Release After Tapentadol|Participants that drop-out of the double-blind tapentadol prolonged release treatment in the Comparative Period, due to tolerability issues, continued on Tapentadol Prolonged Release at either 300 mg per day or 400 mg per day in this Open-Label Pick-up arm.
262474|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Participants that did not qualify for randomization to the Comparator Period, continued on a stable dose of Tapentadol Prolonged Release 300 mg per day, if they had reached a satisfactory level of pain relief.
262475|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration.
262999|NCT01350804|O9|Outcome|Abatacept Responders|Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).
262476|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
262477|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
262478|NCT01352741|E5|Reported Event|Open-Label Tapentadol Continuation Period|Participants who did not qualify for randomization to the Comparator Period, continued on a stable dose of Tapentadol Prolonged Release 300 mg per day if they had reached a satisfactory level of pain relief.
262479|NCT01352741|E4|Reported Event|Open-Label Tapentadol Pick-Up Arm|Participants that drop-out of the Comparative Period, due to tolerability issues, were permitted to continue on Tapentadol Prolonged Release at either 300 mg per day or 400 mg per day.
262480|NCT01352741|E3|Reported Event|Tapentadol and Pregabalin in the Comparative Period|Tapentadol Prolonged Release 300 mg per day (2 x 150 mg) plus Pregabalin 2 x 75 mg (total daily dose of 150 mg). A week later the dose of Pregabalin was increased to a total daily dose of 300 mg per day (2 x 150 mg), the Tapentadol Prolonged Release dose remained at 300 mg per day.
262481|NCT01352741|E2|Reported Event|Tapentadol in the Comparative Period|The dose of Tapentadol Prolonged Release was increased to 400 mg (2 x 200mg) and a week later to 500 mg (2 x 250 mg) per day and maintained at 500 mg per day.
262482|NCT01352741|E1|Reported Event|Open-Label Tapentadol Titration Period|"During the 3-week Titration Period, Tapentadol Prolonged Release was administered in an open-label fashion.~Titration dose steps on a weekly basis:~First 50 mg administered twice daily, then 100 mg administered twice daily and then 150 mg administered twice daily.~The titration period could be shortened to 10 days, with a participant at a predefined dose level for at least 3 days.~The dose of 300 mg Tapentadol per day was maintained until the Randomization Visit."
262483|NCT01352715|B3|Baseline|Total|Total of all reporting groups
262484|NCT01352715|B2|Baseline|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
262485|NCT01352715|B1|Baseline|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
262486|NCT01352715|P2|Participant Flow|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
262487|NCT01352715|P1|Participant Flow|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
262488|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
262489|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
262490|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
262491|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
262564|NCT01352468|O2|Outcome|Sham Cognitive Training|"Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training~Multifaceted cognitive training: Four computerized training tasks"
263439|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
262492|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
262493|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
262494|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
262495|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
262496|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
262497|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
262498|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
262499|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
262500|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
262501|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
262502|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
262503|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
262565|NCT01352468|O1|Outcome|Multifaceted Cognitive Training|"Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency.~Multifaceted cognitive training: Four computerized training tasks"
262504|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
262505|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
262506|NCT01352715|E2|Reported Event|LPV/r + NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily. Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily. Lamivudine: Lamivudine 150 mg tablet orally twice daily."
262507|NCT01352715|E1|Reported Event|LPV/r + RAL|Participants were administered LPV/r plus RAL orally twice daily. Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily. Raltegravir: Raltegravir 400 mg tablet orally twice daily.
262508|NCT01352585|B1|Baseline|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
262509|NCT01352585|P1|Participant Flow|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
262510|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
262511|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
262512|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
262513|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
262514|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
262515|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
262516|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
262517|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
262518|NCT01352585|E1|Reported Event|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
262519|NCT01352546|B1|Baseline|BOTOX|"Intravaginal (lateral aspects-bulbospongiosum) Botox injections, bupivacaine injections to the side walls of the vagina (cervix to introitus), progressive dilation under anesthesia and post procedure counseling and support to cure vaginismus.~BOTOX: 150 units of Botox, and bupivacaine injected intravaginally into the bulbocavernosum, pubococcygeus and puborectalis muscles along the lateral side walls, left and right as a one time injection under anesthesia."
262520|NCT01352546|P1|Participant Flow|BOTOX|"Intravaginal (lateral aspects-bulbospongiosum) Botox injections, bupivacaine injections to the side walls of the vagina (cervix to introitus), progressive dilation under anesthesia and post procedure counseling and support to cure vaginismus.~BOTOX: 150 units of Botox, and bupivacaine injected intravaginally into the bulbocavernosum, pubococcygeus and puborectalis muscles along the lateral side walls, left and right as a one time injection under anesthesia."
262521|NCT01352546|O1|Outcome|BOTOX|"Intravaginal (lateral aspects-bulbospongiosum) Botox injections, bupivacaine injections to the side walls of the vagina (cervix to introitus), progressive dilation under anesthesia and post procedure counseling and support to cure vaginismus.~BOTOX: 150 units of Botox, and bupivacaine injected intravaginally into the bulbocavernosum, pubococcygeus and puborectalis muscles along the lateral side walls, left and right as a one time injection under anesthesia."
262522|NCT01352546|E1|Reported Event|BOTOX|"Intravaginal (lateral aspects-bulbospongiosum) Botox injections, bupivacaine injections to the side walls of the vagina (cervix to introitus), progressive dilation under anesthesia and post procedure counseling and support to cure vaginismus.~BOTOX: 150 units of Botox, and bupivacaine injected intravaginally into the bulbocavernosum, pubococcygeus and puborectalis muscles along the lateral side walls, left and right as a one time injection under anesthesia."
262523|NCT01352507|B3|Baseline|Total|Total of all reporting groups
262524|NCT01352507|B2|Baseline|Sildenafil Then Tadalafil|"100 mg sildenafil taken orally, as needed, for 8 weeks, followed by 20 mg tadalafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.~At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for ED."
262525|NCT01352507|B1|Baseline|Tadalafil Then Sildenafil|"20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks, followed by 100 mg sildenafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.~At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for erectile dysfunction (ED)."
262566|NCT01352468|O2|Outcome|Sham Cognitive Training|"Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training~Multifaceted cognitive training: Four computerized training tasks"
262526|NCT01352507|P2|Participant Flow|Sildenafil Then Tadalafil|"100 mg sildenafil taken orally, as needed, for 8 weeks, followed by 20 mg tadalafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.~At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for ED."
262527|NCT01352507|P1|Participant Flow|Tadalafil Then Sildenafil|"20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks, followed by 100 mg sildenafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.~At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for erectile dysfunction (ED)."
262528|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
262529|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
262530|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
262531|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
262532|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
262533|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
262534|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
262535|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
262536|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
262537|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
262538|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
262539|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
262540|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
262541|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
262542|NCT01352507|O2|Outcome|Sildenafil|Participants who preferred sildenafil over tadalafil.
262543|NCT01352507|O1|Outcome|Tadalafil|Participants who preferred tadalafil over sildenafil.
262544|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
262545|NCT01352507|O1|Outcome|Tadalafil|20 mg tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
262546|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
262547|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
262548|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
262549|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
262550|NCT01352507|O2|Outcome|Sildenafil|Participants who preferred sildenafil over tadalafil.
262551|NCT01352507|O1|Outcome|Tadalafil|Participants who preferred tadalafil over sildenafil.
262552|NCT01352507|O1|Outcome|All Randomized Participants|Includes participants randomized to initially receive tadalafil (20 mg taken orally, as needed, for 8 weeks) and participants randomized to initially receive sildenafil (100 mg taken orally, as needed, for 8 weeks).
262553|NCT01352507|E4|Reported Event|Sildenafil (Extension Phase)|Participants who preferred sildenafil over tadalafil received 100 mg sildenafil taken orally, as needed, for an additional 8 weeks.
262554|NCT01352507|E3|Reported Event|Tadalafil (Extension Phase)|Participants who preferred tadalafil over sildenafil received 20 mg tadalafil taken orally, as needed, for an additional 8 weeks.
262555|NCT01352507|E2|Reported Event|Sildenafil (Treatment Periods)|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
262556|NCT01352507|E1|Reported Event|Tadalafil (Treatment Periods)|20 mg tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
262557|NCT01352468|B3|Baseline|Total|Total of all reporting groups
262558|NCT01352468|B2|Baseline|Sham Cognitive Training|"Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training~Multifaceted cognitive training: Four computerized training tasks"
262559|NCT01352468|B1|Baseline|Multifaceted Cognitive Training|"Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency.~Multifaceted cognitive training: Four computerized training tasks"
262560|NCT01352468|P2|Participant Flow|Sham Cognitive Training|"Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training~Multifaceted cognitive training: Four computerized training tasks"
262561|NCT01352468|P1|Participant Flow|Multifaceted Cognitive Training|"Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency.~Multifaceted cognitive training: Four computerized training tasks"
262562|NCT01352468|O2|Outcome|Sham Cognitive Training|"Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training~Multifaceted cognitive training: Four computerized training tasks"
262563|NCT01352468|O1|Outcome|Multifaceted Cognitive Training|"Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency.~Multifaceted cognitive training: Four computerized training tasks"
263440|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
262567|NCT01352468|O1|Outcome|Multifaceted Cognitive Training|"Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency.~Multifaceted cognitive training: Four computerized training tasks"
262568|NCT01352468|E2|Reported Event|Sham Cognitive Training|"Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training~Multifaceted cognitive training: Four computerized training tasks"
262569|NCT01352468|E1|Reported Event|Multifaceted Cognitive Training|"Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency.~Multifaceted cognitive training: Four computerized training tasks"
262570|NCT01352442|B1|Baseline|AcuFocus Corneal Inlay|"The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
262571|NCT01352442|P1|Participant Flow|AcuFocus Corneal Inlay|"The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
262572|NCT01352442|O1|Outcome|AcuFocus Corneal Inlay|"The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
262573|NCT01352442|O1|Outcome|AcuFocus Corneal Inlay|"The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
262574|NCT01352442|E1|Reported Event|AcuFocus Corneal Inlay|"The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
262575|NCT01352416|B5|Baseline|Total|Total of all reporting groups
262576|NCT01352416|B4|Baseline|Placebo Pill and Patients Having Non Heart Bypass Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
262577|NCT01352416|B3|Baseline|Ranolazine and Patients Having Non Heart Bypass Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
262578|NCT01352416|B2|Baseline|Placebo Pill and Patients Having Heart Bypass Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
262579|NCT01352416|B1|Baseline|Ranolazine and Patients Having Heart Bypass Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
262580|NCT01352416|P4|Participant Flow|Sugar Pills and Patients Having Non CABG Heart Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects, or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 1 pill twice daily.~Atrial fibrillation : Once the patient goes into atrial fibrillation, the study drug is still continued. Patient will also be treated with standard drug therapy that their doctor chooses"
262581|NCT01352416|P3|Participant Flow|Ranolazine With Patients Having Non CABG Heart Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
262582|NCT01352416|P2|Participant Flow|Sugar Pill and Patients Having CABG Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects, or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 1 pill twice daily.~Atrial fibrillation : Once the patient goes into atrial fibrillation, the study drug is still continued. Patient will also be treated with standard drug therapy that their doctor chooses"
262583|NCT01352416|P1|Participant Flow|Ranolazine and Patients Having CABG Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
262584|NCT01352416|O4|Outcome|Placebo Without CABG|Placebo 2 pills twice daily without CABG
262585|NCT01352416|O3|Outcome|Ranolazine Without CABG|Ranolazine 500 mg 2 pills twice daily without CABG
262586|NCT01352416|O2|Outcome|Placebo With CABG|Placebo 2 pills twice daily with CABG
262587|NCT01352416|O1|Outcome|Ranolazine With Coronary Artery Bypass Graft (CABG)|Ranolazine 500 mg 2 pills twice a day with Coronary Artery Bypass Graft (CABG)
262588|NCT01352416|E4|Reported Event|Placebo Pill and Patients Having Non Heart Bypass Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
262589|NCT01352416|E3|Reported Event|Ranolazine and Patients Having Non Heart Bypass Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
262622|NCT01352221|O1|Outcome|ST10 - Open-label Continuation From Active Arm in Double-blind|Open-label extension of ST10 active treatment arm from double-blind phase
262590|NCT01352416|E2|Reported Event|Placebo Pill and Patients Having Heart Bypass Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
262591|NCT01352416|E1|Reported Event|Ranolazine and Patients Having Heart Bypass Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
262592|NCT01352221|B3|Baseline|Total|Total of all reporting groups
262593|NCT01352221|B2|Baseline|Placebo|Matching Placebo capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
262594|NCT01352221|B1|Baseline|ST10|ST10: 30 mg Ferric Maltol capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
262595|NCT01352221|P4|Participant Flow|Placebo Switch to Open-label Extension ST10 Treatment|Open-label extension ST10 treatment arm for placebo subjects completing double-blind phase
262596|NCT01352221|P3|Participant Flow|ST10 - Open-label Continuation From Active Arm in Double-blind|Open-label extension of ST10 active treatment arm from double-blind phase
262597|NCT01352221|P2|Participant Flow|Placebo|Matching placebo for ST10 capsules - double-blind phase
262598|NCT01352221|P1|Participant Flow|ST10|30mg ST10 capsules BD - double-blind phase
262599|NCT01352221|O2|Outcome|Placebo Switch to Open-label Extension ST10 Treatment|Open-label extension ST10 treatment arm for placebo subjects completing double-blind phase
262600|NCT01352221|O1|Outcome|ST10 - Open-label Continuation From Active Arm in Double-blind|Open-label extension of ST10 active treatment arm from double-blind phase
262601|NCT01352221|O2|Outcome|Placebo|Matching Placebo capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
262602|NCT01352221|O1|Outcome|ST10|ST10: 30 mg Ferric Maltol capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
262603|NCT01352221|O2|Outcome|Placebo Switch to Open-label Extension ST10 Treatment|Open-label extension ST10 treatment arm for placebo subjects completing double-blind phase
262604|NCT01352221|O1|Outcome|ST10 - Open-label Continuation From Active Arm in Double-blind|Open-label extension of ST10 active treatment arm from double-blind phase
262605|NCT01352221|O2|Outcome|Placebo|Matching Placebo capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
262606|NCT01352221|O1|Outcome|ST10|ST10: 30 mg Ferric Maltol capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
262607|NCT01352221|O2|Outcome|Placebo Switch to Open-label Extension ST10 Treatment|Open-label extension ST10 treatment arm for placebo subjects completing double-blind phase
262608|NCT01352221|O1|Outcome|ST10 - Open-label Continuation From Active Arm in Double-blind|Open-label extension of ST10 active treatment arm from double-blind phase
262609|NCT01352221|O2|Outcome|Placebo Switch to Open-label Extension ST10 Treatment|Open-label extension ST10 treatment arm for placebo subjects completing double-blind phase
262610|NCT01352221|O1|Outcome|ST10 - Open-label Continuation From Active Arm in Double-blind|Open-label extension of ST10 active treatment arm from double-blind phase
262611|NCT01352221|O2|Outcome|Placebo|Matching Placebo capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
262612|NCT01352221|O1|Outcome|ST10|ST10: 30 mg Ferric Maltol capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
262613|NCT01352221|O2|Outcome|Placebo|Matching Placebo capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
262614|NCT01352221|O1|Outcome|ST10|ST10: 30 mg Ferric Maltol capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
262615|NCT01352221|O2|Outcome|Placebo|Matching Placebo capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
262616|NCT01352221|O1|Outcome|ST10|ST10: 30 mg Ferric Maltol capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
262617|NCT01352221|O2|Outcome|Placebo|Matching Placebo capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
262618|NCT01352221|O1|Outcome|ST10|ST10: 30 mg Ferric Maltol capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
262619|NCT01352221|O2|Outcome|Placebo Switch to Open-label Extension ST10 Treatment|Open-label extension ST10 treatment arm for placebo subjects completing double-blind phase
262620|NCT01352221|O1|Outcome|ST10 - Open-label Continuation From Active Arm in Double-blind|Open-label extension of ST10 active treatment arm from double-blind phase
262623|NCT01352221|O2|Outcome|Placebo Switch to Open-label Extension ST10 Treatment|Open-label extension ST10 treatment arm for placebo subjects completing double-blind phase
262624|NCT01352221|O1|Outcome|ST10 - Open-label Continuation From Active Arm in Double-blind|Open-label extension of ST10 active treatment arm from double-blind phase
262625|NCT01352221|O2|Outcome|Placebo Switch to Open-label Extension ST10 Treatment|Open-label extension ST10 treatment arm for placebo subjects completing double-blind phase
262626|NCT01352221|O1|Outcome|ST10 - Open-label Continuation From Active Arm in Double-blind|Open-label extension of ST10 active treatment arm from double-blind phase
262627|NCT01352221|O2|Outcome|Placebo Switch to Open-label Extension ST10 Treatment|Open-label extension ST10 treatment arm for placebo subjects completing double-blind phase
262628|NCT01352221|O1|Outcome|ST10 - Open-label Continuation From Active Arm in Double-blind|Open-label extension of ST10 active treatment arm from double-blind phase
262629|NCT01352221|O2|Outcome|Placebo Switch to Open-label Extension ST10 Treatment|Open-label extension ST10 treatment arm for placebo subjects completing double-blind phase
262630|NCT01352221|O1|Outcome|ST10 - Open-label Continuation From Active Arm in Double-blind|Open-label extension of ST10 active treatment arm from double-blind phase
262631|NCT01352221|O2|Outcome|Placebo Switch to Open-label Extension ST10 Treatment|Open-label extension ST10 treatment arm for placebo subjects completing double-blind phase
262632|NCT01352221|O1|Outcome|ST10 - Open-label Continuation From Active Arm in Double-blind|Open-label extension of ST10 active treatment arm from double-blind phase
262633|NCT01352221|O2|Outcome|Placebo Switch to Open-label Extension ST10 Treatment|Open-label extension ST10 treatment arm for placebo subjects completing double-blind phase
262634|NCT01352221|O1|Outcome|ST10 - Open-label Continuation From Active Arm in Double-blind|Open-label extension of ST10 active treatment arm from double-blind phase
262635|NCT01352221|O2|Outcome|Placebo Switch to Open-label Extension ST10 Treatment|Open-label extension ST10 treatment arm for placebo subjects completing double-blind phase
262636|NCT01352221|O1|Outcome|ST10 - Open-label Continuation From Active Arm in Double-blind|Open-label extension of ST10 active treatment arm from double-blind phase
262637|NCT01352221|O2|Outcome|Placebo Switch to Open-label Extension ST10 Treatment|Open-label extension ST10 treatment arm for placebo subjects completing double-blind phase
262638|NCT01352221|O1|Outcome|ST10 - Open-label Continuation From Active Arm in Double-blind|Open-label extension of ST10 active treatment arm from double-blind phase
262639|NCT01352221|O2|Outcome|Placebo|Matching Placebo capsules taken orally twice a day during a 12-week double-blind phase.
262640|NCT01352221|O1|Outcome|ST10|ST10: 30 mg Ferric Maltol capsules taken orally twice a day during a 12-week double-blind phase.
262641|NCT01352221|O2|Outcome|Placebo|Matching Placebo capsules taken orally twice a day during a 12-week double-blind phase.
262642|NCT01352221|O1|Outcome|ST10|ST10: 30 mg Ferric Maltol capsules taken orally twice a day during a 12-week double-blind phase.
262643|NCT01352221|O2|Outcome|Placebo|Matching Placebo capsules taken orally twice a day during a 12-week double-blind phase.
262644|NCT01352221|O1|Outcome|ST10|ST10: 30 mg Ferric Maltol capsules taken orally twice a day during a 12-week double-blind phase.
262645|NCT01352221|O2|Outcome|Placebo|Matching Placebo capsules taken orally twice a day during a 12-week double-blind phase.
262646|NCT01352221|O1|Outcome|ST10|ST10: 30 mg Ferric Maltol capsules taken orally twice a day during a 12-week double-blind phase.
262647|NCT01352221|O2|Outcome|Placebo|Matching Placebo capsules taken orally twice a day during a 12-week double-blind phase.
262648|NCT01352221|O1|Outcome|ST10|ST10: 30 mg Ferric Maltol capsules taken orally twice a day during a 12-week double-blind phase.
262649|NCT01352221|O2|Outcome|Placebo|Matching Placebo capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
262650|NCT01352221|O1|Outcome|ST10|ST10: 30 mg Ferric Maltol capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
262651|NCT01352221|E4|Reported Event|Placebo Switch to ST10 Treatment-Safety Set, Open-label Phase|Adverse events reported in the open-label extension phase from those subjects continuing treatment from the double-blind placebo arm; subjects commenced ST10 open-label treatment after completion of the double-blind phase at the Week 12 visit.
262652|NCT01352221|E3|Reported Event|ST10 Continuation - Safety Set, Open-label Phase|Adverse events reported in the open-label extension phase for continuation of active treatment with ST10 (Ferric Maltol) from the double-blind phase active treatment arm
262653|NCT01352221|E2|Reported Event|Placebo - Safety Set, Double-blind Phase|Adverse events reported in the double-blind phase placebo treatment arm. Matching placebo capsules for ST10 taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase
262654|NCT01352221|E1|Reported Event|ST10 - Safety Set, Double-blind Phase|Adverse events reported in the double-blind phase active treatment arm with ST10 (Ferric Maltol). ST10 30 mg capsules taken orally twice a day during a 12-week double-blind phase. For study participants in the UK, DE and HU only, the 12-week double-blind phase was followed by a 52-week open-label ST10 extension treatment phase.
262655|NCT01352117|B3|Baseline|Total|Total of all reporting groups
262656|NCT01352117|B2|Baseline|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
262657|NCT01352117|B1|Baseline|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
262658|NCT01352117|P2|Participant Flow|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
262659|NCT01352117|P1|Participant Flow|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
262877|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
262660|NCT01352117|O1|Outcome|Arm A: ART With Delayed ET Period (Step 2)|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. This analysis was limited to the ART with delayed ET period (Step 2).
262661|NCT01352117|O1|Outcome|Arm A: ART With Delayed ET Period (Step 2)|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. This analysis was limited to the ART with delayed ET period (Step 2).
262662|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
262663|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
262664|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
262665|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
262666|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
262667|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
262668|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
262669|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
262670|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
262671|NCT01352117|O1|Outcome|Arm A: ART With Delayed ET (Step 2)|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. This analysis is limited to Arm A participants who entered Step 2 to initiate delayed ET.
262672|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
262673|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
262674|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
262675|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
262676|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
262677|NCT01352117|O1|Outcome|Arm A: ART Alone Period (Step 1)|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. This analysis used the ART alone period (Step 1) prior to initiation of delayed ET in Step 2.
262678|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
262679|NCT01352117|O1|Outcome|Arm A: ART Alone Period (Step 1)|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. This analysis used the ART alone period (Step 1) prior to initiation of delayed ET in Step 2.
262680|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
262681|NCT01352117|O1|Outcome|Arm A: ART Alone Period (Step 1)|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. This analysis used the ART alone period (Step 1) prior to initiation of delayed ET in Step 2.
262682|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
262683|NCT01352117|O1|Outcome|Arm A: ART Alone Period (Step 1)|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. This analysis used the ART alone period (Step 1) prior to initiation of delayed ET in Step 2.
262684|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
262685|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
262686|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
262687|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
262688|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
262689|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
262690|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
262691|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
262692|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
262693|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
262694|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
262695|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
262696|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
262697|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
262698|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
262699|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
262700|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
262701|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
262702|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
262703|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
262704|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
262705|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
262706|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
262707|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
262708|NCT01352117|E2|Reported Event|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
262709|NCT01352117|E1|Reported Event|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
262710|NCT01351623|B1|Baseline|Carfilzomib|"A single arm, open-label, single institution phase 2 clinical trial is planned.~Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle."
262711|NCT01351623|P1|Participant Flow|Carfilzomib|"A single arm, open-label, single institution phase 2 clinical trial is planned.~Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle."
262712|NCT01351623|O1|Outcome|Carfilzomib|"A single arm, open-label, single institution phase 2 clinical trial is planned.~Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle."
262713|NCT01351623|E1|Reported Event|Carfilzomib|"A single arm, open-label, single institution phase 2 clinical trial is planned.~Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle."
262714|NCT01351506|B3|Baseline|Total|Total of all reporting groups
262715|NCT01351506|B2|Baseline|ICU Non Survivors|Patients who non survivors from ICU discharge status
262716|NCT01351506|B1|Baseline|ICU Survivors|Patients who survivors from ICU discharge status
262717|NCT01351506|P1|Participant Flow|Cohort Patient|A total of 602 patients as inclusion criteria between May 2011 and August 2012 were enrolled on the ICU admission (day 0). One hundred thirty seven patients were excluded due to a short stay in ICU or were not weighed a second time on day 1. The remainder of 465 patients were included and followed in this study.
262718|NCT01351506|O2|Outcome|> 5%|Maximum weight change upto 7 days more than 5% of admission weight
262719|NCT01351506|O1|Outcome|</= 5%|Maximum weight change upto 7 days less than or equal to 5% of admission body weight
262720|NCT01351506|O2|Outcome|> 5%|Maximum weight change upto 7 days more than 5% of admission weight
262721|NCT01351506|O1|Outcome|</= 5%|Maximum weight change upto 7 days less than or equal to 5% of admission body weight
262722|NCT01351506|O2|Outcome|> 5%|Maximum weight change upto 7 days more than 5% of admission weight
262723|NCT01351506|O1|Outcome|</= 5%|Maximum weight change upto 7 days less than or equal to 5% of admission body weight
262724|NCT01351506|E2|Reported Event|> 5%|Maximum weight change upto 7 days more than 5% of admission weight
262725|NCT01351506|E1|Reported Event|</= 5%|Maximum weight change upto 7 days less than or equal to 5% of admission body weight
262878|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
262726|NCT01351480|B1|Baseline|Abatacept|"open label use of abatacept for 12 months~abatacept: Abatacept administered SC weekly at 125 mg dose"
262727|NCT01351480|P1|Participant Flow|Abatacept|"open label use of abatacept for 12 months~abatacept: Abatacept administered SC weekly at 125 mg dose"
262728|NCT01351480|O1|Outcome|Abatacept|"open label use of abatacept for 12 months~abatacept: Abatacept administered SC weekly at 125 mg dose"
262729|NCT01351480|O1|Outcome|Abatacept|"open label use of abatacept for 12 months~abatacept: Abatacept administered SC weekly at 125 mg dose"
262730|NCT01351480|O1|Outcome|Abatacept|"open label use of abatacept for 12 months~abatacept: Abatacept administered SC weekly at 125 mg dose"
262731|NCT01351480|O1|Outcome|Abatacept|"open label use of abatacept for 12 months~abatacept: Abatacept administered SC weekly at 125 mg dose"
262732|NCT01351480|O1|Outcome|Abatacept|"open label use of abatacept for 12 months~abatacept: Abatacept administered SC weekly at 125 mg dose"
262733|NCT01351480|E1|Reported Event|Abatacept|"open label use of abatacept for 12 months~abatacept: Abatacept administered SC weekly at 125 mg dose"
262734|NCT01351415|B3|Baseline|Total|Total of all reporting groups
262735|NCT01351415|B2|Baseline|Standard of Care|Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
262736|NCT01351415|B1|Baseline|Bevacizumab + Standard of Care|Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
262737|NCT01351415|P2|Participant Flow|Standard of Care|Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
262738|NCT01351415|P1|Participant Flow|Bevacizumab + Standard of Care|Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
262739|NCT01351415|O2|Outcome|Standard of Care|Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
262740|NCT01351415|O1|Outcome|Bevacizumab + Standard of Care|Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
262741|NCT01351415|O2|Outcome|Standard of Care|Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
262742|NCT01351415|O1|Outcome|Bevacizumab + Standard of Care|Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
262743|NCT01351415|O2|Outcome|Standard of Care|Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
262744|NCT01351415|O1|Outcome|Bevacizumab + Standard of Care|Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
262745|NCT01351415|O2|Outcome|Standard of Care|Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
262746|NCT01351415|O1|Outcome|Bevacizumab + Standard of Care|Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
262747|NCT01351415|O2|Outcome|Standard of Care|Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
262748|NCT01351415|O1|Outcome|Bevacizumab + Standard of Care|Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
262749|NCT01351415|O2|Outcome|Standard of Care|Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
262750|NCT01351415|O1|Outcome|Bevacizumab + Standard of Care|Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
262751|NCT01351415|O2|Outcome|Standard of Care|Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
262752|NCT01351415|O1|Outcome|Bevacizumab + Standard of Care|Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
262753|NCT01351415|O2|Outcome|Standard of Care|Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
262754|NCT01351415|O1|Outcome|Bevacizumab + Standard of Care|Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
262755|NCT01351415|E2|Reported Event|Standard of Care|Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
262756|NCT01351415|E1|Reported Event|Bevacizumab + Standard of Care|Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
262757|NCT01351337|B1|Baseline|Intraoperative Functional Monitoring|"intraoperative functional monitoring~diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation: All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
262758|NCT01351337|P1|Participant Flow|Intraoperative Functional Monitoring|"intraoperative functional monitoring and diffusion tensor tractography~All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
262759|NCT01351337|O1|Outcome|Intraoperative Functional Monitoring|"intraoperative functional monitoring and diffusion tensor tractography~All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
262760|NCT01351337|O1|Outcome|Intraoperative Functional Monitoring|"intraoperative functional monitoring~diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation: All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
262761|NCT01351337|O1|Outcome|Intraoperative Functional Monitoring|"intraoperative functional monitoring~diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation: All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
262762|NCT01351337|E1|Reported Event|Intraoperative Functional Monitoring|"intraoperative functional monitoring~diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation: All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
262763|NCT01351090|B4|Baseline|Total|Total of all reporting groups
262764|NCT01351090|B3|Baseline|Placebo Vehicle IN|Intranasal placebo
262765|NCT01351090|B2|Baseline|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
262766|NCT01351090|B1|Baseline|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
262767|NCT01351090|P3|Participant Flow|Placebo Vehicle IN|Intranasal placebo
262768|NCT01351090|P2|Participant Flow|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
262769|NCT01351090|P1|Participant Flow|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
262770|NCT01351090|O3|Outcome|Placebo Vehicle IN|Intranasal placebo
262771|NCT01351090|O2|Outcome|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
262772|NCT01351090|O1|Outcome|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
262773|NCT01351090|O3|Outcome|Placebo Vehicle IN|Intranasal placebo
262774|NCT01351090|O2|Outcome|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
262775|NCT01351090|O1|Outcome|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
262776|NCT01351090|O3|Outcome|Placebo Vehicle IN|Intranasal placebo
262777|NCT01351090|O2|Outcome|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
262778|NCT01351090|O1|Outcome|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
262779|NCT01351090|O3|Outcome|Placebo Vehicle IN|Intranasal placebo
262780|NCT01351090|O2|Outcome|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
262781|NCT01351090|O1|Outcome|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
262782|NCT01351090|E3|Reported Event|Placebo Vehicle IN|Intranasal placebo
262783|NCT01351090|E2|Reported Event|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
262784|NCT01351090|E1|Reported Event|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
262785|NCT01351077|B3|Baseline|Total|Total of all reporting groups
262786|NCT01351077|B2|Baseline|CHICA DevScreen Control|This arm will get CHICA without the developmental screening module
262787|NCT01351077|B1|Baseline|CHICA DevScreen Module|"This arm will get the CHICA Developmental Screening Module~CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening"
262788|NCT01351077|P2|Participant Flow|CHICA DevScreen Control|This arm will get CHICA without the developmental screening module
262789|NCT01351077|P1|Participant Flow|CHICA DevScreen Module|"This arm will get the CHICA Developmental Screening Module~CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening"
262790|NCT01351077|O2|Outcome|CHICA DevScreen Control|This arm will get CHICA without the developmental screening module
262791|NCT01351077|O1|Outcome|CHICA DevScreen Module|"This arm will get the CHICA Developmental Screening Module~CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening"
262792|NCT01351077|O2|Outcome|CHICA DevScreen Control|This arm will get CHICA without the developmental screening module
262793|NCT01351077|O1|Outcome|CHICA DevScreen Module|"This arm will get the CHICA Developmental Screening Module~CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening"
262794|NCT01351077|O2|Outcome|CHICA DevScreen Control|This arm will get CHICA without the developmental screening module
262795|NCT01351077|O1|Outcome|CHICA DevScreen Module|"This arm will get the CHICA Developmental Screening Module~CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening"
262796|NCT01351077|O2|Outcome|CHICA DevScreen Control|This arm will get CHICA without the developmental screening module
262797|NCT01351077|O1|Outcome|CHICA DevScreen Module|"This arm will get the CHICA Developmental Screening Module~CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening"
262798|NCT01351077|O2|Outcome|CHICA DevScreen Control|This arm will get CHICA without the developmental screening module
262799|NCT01351077|O1|Outcome|CHICA DevScreen Module|"This arm will get the CHICA Developmental Screening Module~CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening"
262800|NCT01351077|E2|Reported Event|CHICA DevScreen Control|This arm will get CHICA without the developmental screening module
262879|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
262801|NCT01351077|E1|Reported Event|CHICA DevScreen Module|"This arm will get the CHICA Developmental Screening Module~CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening"
262802|NCT01351064|B3|Baseline|Total|Total of all reporting groups
262803|NCT01351064|B2|Baseline|CHICA ADHD Control|This arm received CHICA without the ADHD module
262804|NCT01351064|B1|Baseline|CHICA ADHD Module|"This arm received The CHICA ADHD Module~CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD"
262805|NCT01351064|P2|Participant Flow|CHICA ADHD Control|This arm received CHICA without the ADHD module
262806|NCT01351064|P1|Participant Flow|CHICA ADHD Module|"This arm received The Child Health Improvement through Computer Automation (CHICA) Attention Deficit Hyperactivity Disorder (ADHD) Module~CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD"
262807|NCT01351064|O2|Outcome|CHICA ADHD Control|This arm received CHICA without the ADHD module
262808|NCT01351064|O1|Outcome|CHICA ADHD Module|"This arm received The CHICA ADHD Module~CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD"
262809|NCT01351064|O2|Outcome|CHICA ADHD Control|This arm received CHICA without the ADHD module
262810|NCT01351064|O1|Outcome|CHICA ADHD Module|"This arm received The CHICA ADHD Module~CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD"
262811|NCT01351064|E2|Reported Event|CHICA ADHD Control|This arm received CHICA without the ADHD module
262812|NCT01351064|E1|Reported Event|CHICA ADHD Module|"This arm received The CHICA ADHD Module~CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD"
262813|NCT01351025|B3|Baseline|Total|Total of all reporting groups
262814|NCT01351025|B2|Baseline|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
262815|NCT01351025|B1|Baseline|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
262816|NCT01351025|P2|Participant Flow|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
262817|NCT01351025|P1|Participant Flow|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
262818|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
262819|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
262820|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
262821|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
262880|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
262881|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
262822|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
262823|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
262824|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
262825|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
262826|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
262827|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
262828|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
262829|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
262830|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
262831|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
262832|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
262833|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
262834|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
262835|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
262836|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
262837|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
262838|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
262839|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
262840|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
262841|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
262842|NCT01351025|E4|Reported Event|Arm B: Placebo / Atorvastatin After Cross-over (Week 24 - 48)|At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
262843|NCT01351025|E3|Reported Event|Arm A: Atorvastatin / Placebo After Cross-over (Week 24 - 48)|At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
262844|NCT01351025|E2|Reported Event|Arm B: Placebo / Atorvastatin Before Cross-over (Week 0 - 24)|At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
262845|NCT01351025|E1|Reported Event|Arm A: Atorvastatin / Placebo Before Cross-over (Week 0 - 24)|At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
262846|NCT01350999|B4|Baseline|Total|Total of all reporting groups
262847|NCT01350999|B3|Baseline|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
262848|NCT01350999|B2|Baseline|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
262849|NCT01350999|B1|Baseline|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
262850|NCT01350999|P3|Participant Flow|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
262851|NCT01350999|P2|Participant Flow|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
262852|NCT01350999|P1|Participant Flow|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
262853|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
262854|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
262855|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
262856|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
262857|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
262858|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
262859|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
262860|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
262861|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
262862|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
262863|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
262864|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
262865|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
262866|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
262867|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
262868|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
262869|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
262870|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
262871|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
262872|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
262873|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
262874|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
262875|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
262876|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
262882|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
262883|NCT01350999|E3|Reported Event|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
262884|NCT01350999|E2|Reported Event|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
262885|NCT01350999|E1|Reported Event|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
262886|NCT01350973|B4|Baseline|Total|Total of all reporting groups
262887|NCT01350973|B3|Baseline|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
262888|NCT01350973|B2|Baseline|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
262889|NCT01350973|B1|Baseline|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
262890|NCT01350973|P3|Participant Flow|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
262891|NCT01350973|P2|Participant Flow|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
262892|NCT01350973|P1|Participant Flow|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
262893|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
262894|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
262895|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
262896|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
262897|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
262898|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
262899|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
262900|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
262901|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
262902|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
262903|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
262904|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
262905|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
262906|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
262907|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
262908|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
262909|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
262910|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
262911|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
262912|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
262913|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
262914|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
262915|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
262916|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
262917|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
262918|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
262919|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
262920|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
262921|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
262922|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
262923|NCT01350973|E3|Reported Event|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
262924|NCT01350973|E2|Reported Event|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
262925|NCT01350973|E1|Reported Event|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
262926|NCT01350947|B1|Baseline|All Patients|"All participants enrolled.~5-Azacitidine: Administered on Days 1-7 of each Cycle.~Subcutaneous administration:~To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.~The 5-azacitidine suspension is administered subcutaneously.~Intravenous Administration:~5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes."
262927|NCT01350947|P1|Participant Flow|Arm 1 - 5-Azacitidine|"All participants enrolled.~5-Azacitidine: Administered on Days 1-7 of each Cycle.~Subcutaneous administration:~To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.~The 5-azacitidine suspension is administered subcutaneously.~Intravenous Administration:~5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes."
262928|NCT01350947|O1|Outcome|Arm 1 - 5-Azacitidine|"All participants enrolled.~5-Azacitidine: Administered on Days 1-7 of each Cycle.~Subcutaneous administration:~To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.~The 5-azacitidine suspension is administered subcutaneously.~Intravenous Administration:~5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes."
262960|NCT01350804|O11|Outcome|Abatacept Non-responders - AIN457 150mg|Participants switched from abatacept to AIN457 150 mg starting at week 24.
263441|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
262929|NCT01350947|E1|Reported Event|Arm 1 - 5-Azacitidine|"All participants enrolled.~5-Azacitidine: Administered on Days 1-7 of each Cycle.~Subcutaneous administration:~To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.~The 5-azacitidine suspension is administered subcutaneously.~Intravenous Administration:~5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes."
262930|NCT01350934|B3|Baseline|Total|Total of all reporting groups
262931|NCT01350934|B2|Baseline|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
262932|NCT01350934|B1|Baseline|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
262933|NCT01350934|P2|Participant Flow|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
262934|NCT01350934|P1|Participant Flow|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
262935|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
262936|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
262937|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
262938|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
262939|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
262940|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
262941|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
262942|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
262943|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
262944|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
262945|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
262946|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
262947|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
262948|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
262949|NCT01350934|E2|Reported Event|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
262950|NCT01350934|E1|Reported Event|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
262951|NCT01350804|B5|Baseline|Total|Total of all reporting groups
262952|NCT01350804|B4|Baseline|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
262953|NCT01350804|B3|Baseline|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
262954|NCT01350804|B2|Baseline|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
262955|NCT01350804|B1|Baseline|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
262956|NCT01350804|P4|Participant Flow|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
262957|NCT01350804|P3|Participant Flow|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
262958|NCT01350804|P2|Participant Flow|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
262959|NCT01350804|P1|Participant Flow|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
262961|NCT01350804|O10|Outcome|Abatacept Non-responders - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
262962|NCT01350804|O9|Outcome|Abatacept Responders|Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).
262963|NCT01350804|O8|Outcome|Placebo Responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 24.
262964|NCT01350804|O7|Outcome|Placebo Responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
262965|NCT01350804|O6|Outcome|Placebo Non-responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 16.
262966|NCT01350804|O5|Outcome|Placebo Non-responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 16.
262967|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
262968|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
262969|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
262970|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
262971|NCT01350804|O11|Outcome|Abatacept Non-responders - AIN457 150mg|Participants switched from abatacept to AIN457 150 mg starting at week 24.
262972|NCT01350804|O10|Outcome|Abatacept Non-responders - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
262973|NCT01350804|O9|Outcome|Abatacept Responders|Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).
262974|NCT01350804|O8|Outcome|Placebo Responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 24.
262975|NCT01350804|O7|Outcome|Placebo Responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
262976|NCT01350804|O6|Outcome|Placebo Non-responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 16.
262977|NCT01350804|O5|Outcome|Placebo Non-responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 16.
262978|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
262979|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
262980|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
262981|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
262982|NCT01350804|O11|Outcome|Abatacept Non-responders - AIN457 150mg|Participants switched from abatacept to AIN457 150 mg starting at week 24.
262983|NCT01350804|O10|Outcome|Abatacept Non-responders - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
262984|NCT01350804|O9|Outcome|Abatacept Responders|Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).
262985|NCT01350804|O8|Outcome|Placebo Responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 24.
262986|NCT01350804|O7|Outcome|Placebo Responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
262987|NCT01350804|O6|Outcome|Placebo Non-responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 16.
262988|NCT01350804|O5|Outcome|Placebo Non-responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 16.
262989|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
262990|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
262991|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
262992|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
262993|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
262994|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
262995|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
262996|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
262997|NCT01350804|O11|Outcome|Abatacept Non-responders - AIN457 150mg|Participants switched from abatacept to AIN457 150 mg starting at week 24.
262998|NCT01350804|O10|Outcome|Abatacept Non-responders - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
263442|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
263000|NCT01350804|O8|Outcome|Placebo Responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 24.
263001|NCT01350804|O7|Outcome|Placebo Responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
263002|NCT01350804|O6|Outcome|Placebo Non-responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 16.
263003|NCT01350804|O5|Outcome|Placebo Non-responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 16.
263004|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
263005|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
263006|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
263007|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
263008|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
263009|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
263010|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
263011|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
263012|NCT01350804|O11|Outcome|Abatacept Non-responders - AIN457 150mg|Participants switched from abatacept to AIN457 150 mg starting at week 24.
263013|NCT01350804|O10|Outcome|Abatacept Non-respnders - AIN457 75mg|Participants switched from abatacept to AIN457 75 mg starting at week 24.
263014|NCT01350804|O9|Outcome|Abatacept Responders|Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).
263015|NCT01350804|O8|Outcome|Placebo Responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 24.
263016|NCT01350804|O7|Outcome|Placebo Responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
263017|NCT01350804|O6|Outcome|Placebo Non-responder - AIN457 150 mg|Participants switched from placebo to AIN457 150 mg starting at week 16.
263018|NCT01350804|O5|Outcome|Placebo Non-responder - AIN457 75 mg|Participants switched from placebo to AIN457 75 mg starting at week 16.
263019|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
263020|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
263021|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
263022|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
263023|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
263024|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
263025|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
263026|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
263027|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
263028|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
263029|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
263030|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
263031|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
263032|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
263033|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
263034|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
263035|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
263036|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
263037|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
263038|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
263039|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
263040|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
263041|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
263042|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
263043|NCT01350804|E4|Reported Event|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
263044|NCT01350804|E3|Reported Event|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
263045|NCT01350804|E2|Reported Event|Any AIN457 150 mg|Any AIN457 150 mg
263046|NCT01350804|E1|Reported Event|Any AIN457 75 mg|Any AIN457 75 mg
263047|NCT01350583|B1|Baseline|Sodium Bicarbonate Therapy|"Dose Escalation~Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
263048|NCT01350583|P1|Participant Flow|Sodium Bicarbonate Therapy|"Dose Escalation~Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
263049|NCT01350583|O1|Outcome|Sodium Bicarbonate Therapy|"Dose Escalation~Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
263050|NCT01350583|O1|Outcome|Sodium Bicarbonate Therapy|"Dose Escalation~Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
263051|NCT01350583|O1|Outcome|Sodium Bicarbonate Therapy|"Dose Escalation~Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
263052|NCT01350583|E1|Reported Event|Sodium Bicarbonate Therapy|"Dose Escalation~Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
263053|NCT01350544|B3|Baseline|Total|Total of all reporting groups
263054|NCT01350544|B2|Baseline|Treatment Advocacy|Treatment advocacy is a 24-week intervention with booster sessions, including a 4-week intensive intervention followed by a 20-week maintenance period. In the first 4 weeks, participants receive 4 individual weekly 60-minute sessions and 1 group HIV education session. In the next 20 weeks, all participants receive booster sessions in weeks 12 and 20, and a counselor check-in phone call in week 8 regarding need for new referrals and adherence barriers. Participants who have not demonstrated good adherence (≥90%) during the prior 2 weeks receive ≤4 additional booster sessions at weeks 14, 16, 22, and 24. Clients receive additional linkage with APLA's social service programs, as necessary.
263055|NCT01350544|B1|Baseline|Wait-list Control|Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment.
263056|NCT01350544|P2|Participant Flow|Treatment Advocacy|Treatment advocacy is a 24-week intervention with booster sessions, including a 4-week intensive intervention followed by a 20-week maintenance period. In the first 4 weeks, participants receive 4 individual weekly 60-minute sessions and 1 group HIV education session. In the next 20 weeks, all participants receive booster sessions in weeks 12 and 20, and a counselor check-in phone call in week 8 regarding need for new referrals and adherence barriers. Participants who have not demonstrated good adherence (≥90%) during the prior 2 weeks receive ≤4 additional booster sessions at weeks 14, 16, 22, and 24. Clients receive additional linkage with APLA's social service programs, as necessary.
263057|NCT01350544|P1|Participant Flow|Wait-list Control|Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment.
263090|NCT01350401|O1|Outcome|NYESO-1ᶜ²⁵⁹T Cells Administered IV as a Split Dose Over 2 Days|Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 5-10 billion cells)
263091|NCT01350401|O4|Outcome|Subject 2 - Day 60|
263058|NCT01350544|O2|Outcome|Treatment Advocacy|Treatment Advocacy: Treatment advocacy is a 24-week intervention with booster sessions, including a 4-week intensive intervention followed by a 20-week maintenance period. In the first 4 weeks, all participants receive 4 individual weekly 60-minute sessions and 1 group HIV education session. In the next 20 weeks, all participants receive booster sessions in weeks 12 and 20, and a counselor check-in phone call in week 8 regarding need for new referrals and adherence barriers. Participants who have not demonstrated good adherence (≥90%) during the prior 2 weeks receive ≤4 additional booster sessions at weeks 14, 16, 22, and 24. Clients receive additional linkage with APLA's social service programs, as necessary. This description is subject to change after consideration by the community advisory board.
263059|NCT01350544|O1|Outcome|Wait-list Control|Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment.
263060|NCT01350544|E2|Reported Event|Treatment Advocacy|Treatment advocacy is a 24-week intervention with booster sessions, including a 4-week intensive intervention followed by a 20-week maintenance period. In the first 4 weeks, participants receive 4 individual weekly 60-minute sessions and 1 group HIV education session. In the next 20 weeks, all participants receive booster sessions in weeks 12 and 20, and a counselor check-in phone call in week 8 regarding need for new referrals and adherence barriers. Participants who have not demonstrated good adherence (≥90%) during the prior 2 weeks receive ≤4 additional booster sessions at weeks 14, 16, 22, and 24. Clients receive additional linkage with APLA's social service programs, as necessary.
263061|NCT01350544|E1|Reported Event|Wait-list Control|Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment.
263062|NCT01350479|B3|Baseline|Total|Total of all reporting groups
263063|NCT01350479|B2|Baseline|Not MRSA Colonized|Residents not colonized with MRSA by culture at study admission
263064|NCT01350479|B1|Baseline|MRSA Colonized|Residents colonized with MRSA by culture at study admission
263065|NCT01350479|P2|Participant Flow|Not MRSA Colonized|Residents not colonized with MRSA by culture at study admission
263066|NCT01350479|P1|Participant Flow|MRSA Colonized|Residents colonized with MRSA by culture at study admission
263067|NCT01350479|O2|Outcome|Swabs From Interactions With Not MRSA Colonized Residents|Swabs collected from healthcare workers interacting with residents not colonized with MRSA by culture on enrollment
263068|NCT01350479|O1|Outcome|Swabs From Interactions With MRSA Colonized Residents|Swabs collected from healthcare workers interacting with residents colonized with MRSA by culture on enrollment
263069|NCT01350479|E2|Reported Event|Not MRSA Colonized|Residents not colonized with MRSA by culture at study admission
263070|NCT01350479|E1|Reported Event|MRSA Colonized|Residents colonized with MRSA by culture at study admission
263071|NCT01350414|B1|Baseline|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02, NCT00231114).
263072|NCT01350414|P1|Participant Flow|Alair Group|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02)~Bronchial Thermoplasty with the Alair System: Bronchial Thermoplasty with the Alair System"
263073|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol Number 04-02, NCT00231114).
263074|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
263075|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
263076|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
263077|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
263078|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
263079|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).
263080|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).
263081|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
263082|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
263083|NCT01350414|E5|Reported Event|Year 5|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).~Year 5 is defined as 1461 days to 1826 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 5 annual visit or not."
263084|NCT01350414|E4|Reported Event|Year 4|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).~Year 4 is defined as 1096 to 1460 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 4 annual visit or not."
263085|NCT01350414|E3|Reported Event|Year 3|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).~Year 3 is defined as 731 to 1095 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 3 annual visit or not."
263086|NCT01350414|E2|Reported Event|Year 2|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).~Year 2 is defined as 366 to 730 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 2 annual visit or not."
263087|NCT01350414|E1|Reported Event|Year 1|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).~Year 1 is defined as 365 days from the treatment period (6 weeks after the last bronchoscopy). All subjects were considered in the analysis regardless of whether they have completed the Year 1 annual visit or not."
263088|NCT01350401|B1|Baseline|NYESO-1ᶜ²⁵⁹T Cells Administered IV as a Split Dose Over 2 Days|Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 5-10 billion cells)
263089|NCT01350401|P1|Participant Flow|NYESO-1ᶜ²⁵⁹T Cells Administered IV as a Split Dose Over 2 Days|Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 5-10 billion cells)
263094|NCT01350401|O1|Outcome|Subject 1 - Manufactured Product|Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 5-10 billion cells)
263095|NCT01350401|O1|Outcome|NYESO-1ᶜ²⁵⁹T Cells Administered IV as a Split Dose Over 2 Days|Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 5-10 billion cells)
263096|NCT01350401|O1|Outcome|NYESO-1ᶜ²⁵⁹T Cells Administered IV as a Split Dose Over 2 Days|Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 5-10 billion cells)
263097|NCT01350401|E1|Reported Event|NYESO-1ᶜ²⁵⁹T Cells Administered IV as a Split Dose Over 2 Days|Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 5-10 billion cells)
263098|NCT01350388|B3|Baseline|Total|Total of all reporting groups
263099|NCT01350388|B2|Baseline|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
263100|NCT01350388|B1|Baseline|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
263101|NCT01350388|P2|Participant Flow|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
263102|NCT01350388|P1|Participant Flow|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
263103|NCT01350388|O2|Outcome|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
263104|NCT01350388|O1|Outcome|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
263105|NCT01350388|O2|Outcome|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
263106|NCT01350388|O1|Outcome|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
263107|NCT01350388|O2|Outcome|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
263108|NCT01350388|O1|Outcome|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
263109|NCT01350388|O2|Outcome|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
263110|NCT01350388|O1|Outcome|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
263111|NCT01350388|O2|Outcome|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
263112|NCT01350388|O1|Outcome|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
263113|NCT01350388|O2|Outcome|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
263114|NCT01350388|O1|Outcome|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
263115|NCT01350388|E2|Reported Event|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
263116|NCT01350388|E1|Reported Event|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
263117|NCT01350271|B4|Baseline|Total|Total of all reporting groups
263118|NCT01350271|B3|Baseline|Mebendazole Polymorph C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph C 500 mg
263119|NCT01350271|B2|Baseline|Mebendazole Polymorph A and C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph A and C 500 mg
263120|NCT01350271|B1|Baseline|Placebo|Hookworm positive participants randomized to placebo
263121|NCT01350271|P3|Participant Flow|Mebendazole Polymorph C 500 mg|74 were allocated and 48 were followed up in the post treatment.
263122|NCT01350271|P2|Participant Flow|Mebendazole Polymorph A and C 500 mg|70 were allocated and 53 were followed up in the post treatment.
263123|NCT01350271|P1|Participant Flow|Placebo|70 were allocated to this arm and 49 were followed up in the post treatment.
263124|NCT01350271|O3|Outcome|Mebendazole Polymorph C 500 mg|Hookworm positive participants randomized to a single dose Mebendazole polymorph C 500 mg
263125|NCT01350271|O2|Outcome|Mebendazole Polymorph A and C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph A and C 500 mg
263126|NCT01350271|O1|Outcome|Placebo|Hookworm positive participants randomized to placebo
263127|NCT01350271|O3|Outcome|Mebendazole Polymorph C 500 mg|Hookworm positive participants randomized to a single dose Mebendazole polymorph C 500 mg
263128|NCT01350271|O2|Outcome|Mebendazole Polymorph A and C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph A and C 500 mg
263129|NCT01350271|O1|Outcome|Placebo|Hookworm positive participants randomized to placebo
263130|NCT01350271|O3|Outcome|Mebendazole Polymorph C 500 mg|Hookworm infected individuals randomized to a single dose of Mebendazole polymorph C 500 mg
263131|NCT01350271|O2|Outcome|Mebendazole Polymorph A and C 500 mg|Hookworm infected individuals randomized to a single dose of Mebendazole polymorph A and C 500 mg
263132|NCT01350271|O1|Outcome|Placebo|Hookworm infected individual randomized to placebo
263133|NCT01350271|E3|Reported Event|Mebendazole Polymorph C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph C 500 mg
263134|NCT01350271|E2|Reported Event|Mebendazole Polymorph A and C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph A and C 500 mg
263135|NCT01350271|E1|Reported Event|Placebo|Hookworm positive participants randomized to placebo
263136|NCT01350258|B1|Baseline|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
263137|NCT01350258|P1|Participant Flow|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
263167|NCT01350141|P1|Participant Flow|Placebo|Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263138|NCT01350258|O1|Outcome|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
263139|NCT01350258|O1|Outcome|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
263140|NCT01350258|O1|Outcome|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
263141|NCT01350258|O1|Outcome|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
263142|NCT01350258|O1|Outcome|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
263143|NCT01350258|O1|Outcome|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
263144|NCT01350258|E1|Reported Event|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
263145|NCT01350245|B1|Baseline|TJU 2 Step Regimen|"All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.~Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).~Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.~Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days~Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)~Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)~Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do"
263146|NCT01350245|P1|Participant Flow|TJU 2 Step Regimen|"All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.~Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).~Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.~Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days~Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)~Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)~Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do"
263147|NCT01350245|O1|Outcome|TJU 2 Step Regimen|"All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.~Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).~Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.~Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days~Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)~Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)~Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do"
263168|NCT01350141|O2|Outcome|PF-04950615 (RN316) 3 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263443|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
263148|NCT01350245|O1|Outcome|TJU 2 Step Regimen|"All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.~Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).~Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.~Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days~Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)~Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)~Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do"
263149|NCT01350245|E1|Reported Event|TJU 2 Step Regimen|"All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.~Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).~Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.~Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days~Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)~Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)~Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do"
263150|NCT01350232|B1|Baseline|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
263151|NCT01350232|P1|Participant Flow|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
263152|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
263153|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
263154|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
263169|NCT01350141|O1|Outcome|PF-04950615 (RN316) 1 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263170|NCT01350141|O3|Outcome|PF-04950615 (RN316) 3 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263444|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
263155|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
263156|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
263157|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
263158|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
263159|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
263160|NCT01350232|E1|Reported Event|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
263161|NCT01350141|B4|Baseline|Total|Total of all reporting groups
263162|NCT01350141|B3|Baseline|PF-04950615 (RN316) 3 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263163|NCT01350141|B2|Baseline|PF-04950615 (RN316) 1 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263164|NCT01350141|B1|Baseline|Placebo|Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263165|NCT01350141|P3|Participant Flow|PF-04950615 (RN316) 3 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263166|NCT01350141|P2|Participant Flow|PF-04950615 (RN316) 1 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263268|NCT01350115|O1|Outcome|LDE225|Participants received 400 mg once daily.
263269|NCT01350115|O2|Outcome|Placebo|Participants received matching placebo.
263171|NCT01350141|O2|Outcome|PF-04950615 (RN316) 1 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263172|NCT01350141|O1|Outcome|Placebo|Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263173|NCT01350141|O3|Outcome|PF-04950615 (RN316) 3 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263174|NCT01350141|O2|Outcome|PF-04950615 (RN316) 1 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263175|NCT01350141|O1|Outcome|Placebo|Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263176|NCT01350141|O3|Outcome|PF-04950615 (RN316) 3 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263177|NCT01350141|O2|Outcome|PF-04950615 (RN316) 1 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263178|NCT01350141|O1|Outcome|Placebo|Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263179|NCT01350141|O3|Outcome|PF-04950615 (RN316) 3 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263180|NCT01350141|O2|Outcome|PF-04950615 (RN316) 1 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263181|NCT01350141|O1|Outcome|Placebo|Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263182|NCT01350141|O3|Outcome|PF-04950615 (RN316) 3 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263183|NCT01350141|O2|Outcome|PF-04950615 (RN316) 1 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263184|NCT01350141|O1|Outcome|Placebo|Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263185|NCT01350141|O3|Outcome|PF-04950615 (RN316) 3 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263186|NCT01350141|O2|Outcome|PF-04950615 (RN316) 1 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263187|NCT01350141|O1|Outcome|Placebo|Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263188|NCT01350141|O3|Outcome|PF-04950615 (RN316) 3 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263189|NCT01350141|O2|Outcome|PF-04950615 (RN316) 1 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263190|NCT01350141|O1|Outcome|Placebo|Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263191|NCT01350141|O3|Outcome|PF-04950615 (RN316) 3 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263192|NCT01350141|O2|Outcome|PF-04950615 (RN316) 1 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263193|NCT01350141|O1|Outcome|Placebo|Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263194|NCT01350141|O3|Outcome|PF-04950615 (RN316) 3 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263195|NCT01350141|O2|Outcome|PF-04950615 (RN316) 1 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263196|NCT01350141|O1|Outcome|Placebo|Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263197|NCT01350141|E3|Reported Event|PF-04950615 (RN316) 3 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263270|NCT01350115|O1|Outcome|LDE225|Participants received 400 mg once daily.
263198|NCT01350141|E2|Reported Event|PF-04950615 (RN316) 1 mg/kg|Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263199|NCT01350141|E1|Reported Event|Placebo|Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
263200|NCT01350128|B1|Baseline|ITT Population|ITT Population includes all subjects who were randomized, received at least 1 dose of study treatment, and had both baseline and post-baseline efficacy data for that treatment.
263201|NCT01350128|P1|Participant Flow|All Subjects Randomized|
263202|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
263203|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
263204|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
263205|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
263206|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
263207|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
263208|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
263209|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
263210|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
263211|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
263212|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
263213|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
263214|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
263215|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
263216|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
263217|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
263218|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
263219|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
263220|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
263221|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
263222|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
263223|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
263224|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
263225|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
263226|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
263227|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
263228|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
263229|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
263230|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
263231|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
263232|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
263233|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
263234|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
263235|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
263236|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
263237|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
263238|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
263239|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
263240|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
263241|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
263242|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
263243|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
263244|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
263245|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
263246|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
263247|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
263248|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
263249|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
263250|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
263251|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
263252|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
263253|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
263254|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
263255|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
263256|NCT01350128|E6|Reported Event|Placebo BID|Placebo BID.
263257|NCT01350128|E5|Reported Event|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
263258|NCT01350128|E4|Reported Event|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
263259|NCT01350128|E3|Reported Event|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
263260|NCT01350128|E2|Reported Event|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
263261|NCT01350128|E1|Reported Event|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
263262|NCT01350115|B3|Baseline|Total|Total of all reporting groups
263263|NCT01350115|B2|Baseline|Placebo|Participants received matching placebo.
263264|NCT01350115|B1|Baseline|LDE225|Participants received 400 mg once daily.
263265|NCT01350115|P2|Participant Flow|Placebo|Participants received matching placebo.
263266|NCT01350115|P1|Participant Flow|LDE225|Participants received 400 mg once daily.
263267|NCT01350115|O2|Outcome|Placebo|Participants received matching placebo.
263278|NCT01350102|B4|Baseline|AmeriGel® With Vit C|"AmeriGel® wound care dressing with Vitamin C supplementation~AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing~Vitamin C: Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve"
263279|NCT01350102|B3|Baseline|AmeriGel® Wound Care Dressing Alone|"AmeriGel® wound care dressing alone~AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing"
263280|NCT01350102|B2|Baseline|Bacitracin With Vit C|"Bacitracin wound care dressing with Vitamin C supplementation~Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing~Vitamin C: Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve"
263281|NCT01350102|B1|Baseline|Bacitracin Wound Care Dressing Alone|"Bacitracin wound care dressing alone~Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing"
263282|NCT01350102|P4|Participant Flow|AmeriGel® With Vit C|"AmeriGel® wound care dressing with Vitamin C supplementation~AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing~Vitamin C: Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve"
263283|NCT01350102|P3|Participant Flow|AmeriGel® Wound Care Dressing Alone|"AmeriGel® wound care dressing alone~AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing"
263284|NCT01350102|P2|Participant Flow|Bacitracin With Vit C|"Bacitracin wound care dressing with Vitamin C supplementation~Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing~Vitamin C: Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve"
263285|NCT01350102|P1|Participant Flow|Bacitracin Wound Care Dressing Alone|"Bacitracin wound care dressing alone~Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing"
263286|NCT01350102|O4|Outcome|AmeriGel® With Vit C|"AmeriGel® wound care dressing with Vitamin C supplementation~AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing~Vitamin C: Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve"
263287|NCT01350102|O3|Outcome|AmeriGel® Wound Care Dressing Alone|"AmeriGel® wound care dressing alone~AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing"
263288|NCT01350102|O2|Outcome|Bacitracin With Vit C|"Bacitracin wound care dressing with Vitamin C supplementation~Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing~Vitamin C: Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve"
263289|NCT01350102|O1|Outcome|Bacitracin Wound Care Dressing Alone|"Bacitracin wound care dressing alone~Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing"
263290|NCT01350102|O4|Outcome|AmeriGel® With Vit C|"AmeriGel® wound care dressing with Vitamin C supplementation~AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing~Vitamin C: Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve"
263291|NCT01350102|O3|Outcome|AmeriGel® Wound Care Dressing Alone|"AmeriGel® wound care dressing alone~AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing"
263292|NCT01350102|O2|Outcome|Bacitracin With Vit C|"Bacitracin wound care dressing with Vitamin C supplementation~Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing~Vitamin C: Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve"
263293|NCT01350102|O1|Outcome|Bacitracin Wound Care Dressing Alone|"Bacitracin wound care dressing alone~Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing"
263445|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
263446|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
263447|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
263294|NCT01350102|O4|Outcome|AmeriGel® With Vit C|"AmeriGel® wound care dressing with Vitamin C supplementation~AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing~Vitamin C: Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve"
263295|NCT01350102|O3|Outcome|AmeriGel® Wound Care Dressing Alone|"AmeriGel® wound care dressing alone~AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing"
263296|NCT01350102|O2|Outcome|Bacitracin With Vit C|"Bacitracin wound care dressing with Vitamin C supplementation~Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing~Vitamin C: Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve"
263297|NCT01350102|O1|Outcome|Bacitracin Wound Care Dressing Alone|"Bacitracin wound care dressing alone~Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing"
263298|NCT01350102|E4|Reported Event|AmeriGel® With Vit C|"AmeriGel® wound care dressing with Vitamin C supplementation~AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing~Vitamin C: Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve"
263299|NCT01350102|E3|Reported Event|AmeriGel® Wound Care Dressing Alone|"AmeriGel® wound care dressing alone~AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing"
263300|NCT01350102|E2|Reported Event|Bacitracin With Vit C|"Bacitracin wound care dressing with Vitamin C supplementation~Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing~Vitamin C: Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve"
263301|NCT01350102|E1|Reported Event|Bacitracin Wound Care Dressing Alone|"Bacitracin wound care dressing alone~Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.~Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing"
263302|NCT01349972|B3|Baseline|Total|Total of all reporting groups
263303|NCT01349972|B2|Baseline|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.~daunorubicin hydrochloride: Given IV~cytarabine: Given IV"
263304|NCT01349972|B1|Baseline|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.~alvocidib: Given IV~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV"
263305|NCT01349972|P2|Participant Flow|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.~daunorubicin hydrochloride: Given IV~cytarabine: Given IV"
263306|NCT01349972|P1|Participant Flow|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.~alvocidib: Given IV~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV"
263307|NCT01349972|O2|Outcome|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.~daunorubicin hydrochloride: Given IV~cytarabine: Given IV"
263308|NCT01349972|O1|Outcome|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.~alvocidib: Given IV~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV"
263309|NCT01349972|O2|Outcome|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.~daunorubicin hydrochloride: Given IV~cytarabine: Given IV"
263310|NCT01349972|O1|Outcome|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.~alvocidib: Given IV~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV"
263311|NCT01349972|O2|Outcome|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.~daunorubicin hydrochloride: Given IV~cytarabine: Given IV"
263312|NCT01349972|O1|Outcome|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.~alvocidib: Given IV~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV"
263313|NCT01349972|O2|Outcome|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.~daunorubicin hydrochloride: Given IV~cytarabine: Given IV"
263314|NCT01349972|O1|Outcome|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.~alvocidib: Given IV~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV"
263315|NCT01349972|O2|Outcome|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.~daunorubicin hydrochloride: Given IV~cytarabine: Given IV"
263316|NCT01349972|O1|Outcome|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.~alvocidib: Given IV~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV"
263317|NCT01349972|O2|Outcome|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.~daunorubicin hydrochloride: Given IV~cytarabine: Given IV"
263318|NCT01349972|O1|Outcome|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.~alvocidib: Given IV~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV"
263319|NCT01349972|E2|Reported Event|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.~daunorubicin hydrochloride: Given IV~cytarabine: Given IV"
263320|NCT01349972|E1|Reported Event|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.~alvocidib: Given IV~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV"
263321|NCT01349959|B1|Baseline|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.~Azacitidine: Given SC~Entinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
263322|NCT01349959|P1|Participant Flow|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.~Azacitidine: Given SC~Entinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
263323|NCT01349959|O1|Outcome|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.~Azacitidine: Given SC~Entinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
263324|NCT01349959|O1|Outcome|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.~Azacitidine: Given SC~Entinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
263325|NCT01349959|O1|Outcome|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.~Azacitidine: Given SC~Entinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
263326|NCT01349959|E1|Reported Event|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.~Azacitidine: Given SC~Entinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
263327|NCT01349933|B1|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt inhibitor MK2206: Given PO"
263328|NCT01349933|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt inhibitor MK2206: Given PO"
263329|NCT01349933|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt inhibitor MK2206: Given PO"
263330|NCT01349933|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt inhibitor MK2206: Given PO"
263331|NCT01349933|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt inhibitor MK2206: Given PO"
263332|NCT01349933|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt inhibitor MK2206: Given PO"
263333|NCT01349933|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt inhibitor MK2206: Given PO"
263334|NCT01349933|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt inhibitor MK2206: Given PO"
263335|NCT01349933|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt inhibitor MK2206: Given PO"
263336|NCT01349933|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206: Given PO
263337|NCT01349920|B1|Baseline|Infliximab 5mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
263338|NCT01349920|P1|Participant Flow|Infliximab 5mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
263339|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
263340|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
263341|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
263342|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
263343|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
263344|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
263345|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
263346|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
263347|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
263348|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
263349|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
263350|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
263351|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
263352|NCT01349920|E3|Reported Event|Post-study|From last dose of study drug, up to 24 days after last dose of infliximab
263353|NCT01349920|E2|Reported Event|Infliximab 5mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
263354|NCT01349920|E1|Reported Event|Pre-study|From 4 weeks prior to first dose, up to first dose of infliximab
263355|NCT01349907|B3|Baseline|Total|Total of all reporting groups
263356|NCT01349907|B2|Baseline|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263357|NCT01349907|B1|Baseline|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263358|NCT01349907|P2|Participant Flow|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263359|NCT01349907|P1|Participant Flow|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg twice daily (BID), then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263448|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
263360|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263361|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263362|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263363|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263364|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263365|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263366|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263367|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263368|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263369|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263370|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263371|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263372|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263373|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263374|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263375|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263376|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263377|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263378|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263379|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263380|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263381|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263449|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
263450|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
263382|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263383|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263384|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263385|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263386|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263387|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263388|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263389|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263390|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263391|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263392|NCT01349907|E2|Reported Event|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263393|NCT01349907|E1|Reported Event|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
263394|NCT01349829|B3|Baseline|Total|Total of all reporting groups
263395|NCT01349829|B2|Baseline|Havrix|
263396|NCT01349829|B1|Baseline|HAVpur|
263397|NCT01349829|P2|Participant Flow|Havrix|
263398|NCT01349829|P1|Participant Flow|HAVpur|
263399|NCT01349829|O2|Outcome|Havrix|
263400|NCT01349829|O1|Outcome|HAVpur|
263401|NCT01349829|O2|Outcome|Havrix|
263402|NCT01349829|O1|Outcome|HAVpur|
263403|NCT01349829|O2|Outcome|Havrix|
263404|NCT01349829|O1|Outcome|HAVpur|
263405|NCT01349829|O2|Outcome|Havrix|
263406|NCT01349829|O1|Outcome|HAVpur|
263407|NCT01349829|O2|Outcome|Havrix|
263408|NCT01349829|O1|Outcome|HAVpur|
263409|NCT01349829|O2|Outcome|Havrix|
263410|NCT01349829|O1|Outcome|HAVpur|
263411|NCT01349829|E4|Reported Event|Havrix - Second Vaccination|
263412|NCT01349829|E3|Reported Event|HAVPur - Second Vaccination|
263413|NCT01349829|E2|Reported Event|Havrix - First Vaccination|
263414|NCT01349829|E1|Reported Event|HAVpur - First Vaccination|
263415|NCT01349816|B1|Baseline|Overall Study|All patients randomized and treated
263416|NCT01349816|P1|Participant Flow|Overall Study|Overall Study
263417|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
263418|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
263419|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
263420|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
263421|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
263422|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
263423|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
263424|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
263425|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
263426|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
263427|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
263428|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
263429|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
263430|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
263431|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
263432|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
263433|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
263434|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
263435|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
263436|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
263437|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
263473|NCT01349816|E4|Reported Event|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
263474|NCT01349816|E3|Reported Event|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
263475|NCT01349816|E2|Reported Event|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
263476|NCT01349816|E1|Reported Event|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
263477|NCT01349803|B5|Baseline|Total|Total of all reporting groups
263478|NCT01349803|B4|Baseline|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
263479|NCT01349803|B3|Baseline|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
263480|NCT01349803|B2|Baseline|GP MDI (PT001)|GP MDI 36 mcg
263481|NCT01349803|B1|Baseline|FF MDI (PT005)|FF MDI 9.6 mcg
263482|NCT01349803|P4|Participant Flow|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
263483|NCT01349803|P3|Participant Flow|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
263484|NCT01349803|P2|Participant Flow|GP MDI (PT001)|GP MDI 36 mcg
263485|NCT01349803|P1|Participant Flow|FF MDI (PT005)|FF MDI 9.6 mcg
263486|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
263487|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
263488|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg
263489|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
263490|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
263491|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
263492|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
263493|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
263494|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
263495|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
263496|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
263497|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
263498|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
263499|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
263500|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
263501|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
263502|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
263503|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
263504|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
263505|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
263506|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
263507|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
263508|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
263509|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
263510|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
263511|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
263512|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
263513|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
263514|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
263515|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
263516|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
263517|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
263518|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
263519|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
263520|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
263521|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
263522|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
263523|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
263524|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
263525|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
263526|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
263527|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
263528|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
263529|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
263530|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
263531|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=55 Day 14: N=55
263532|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=57 Day 14: N=57
263533|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=59 Day 14: N=58
263534|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
263535|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
263536|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
263537|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=59 Day 14: N=59
263538|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
263539|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
263540|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg
263541|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
263542|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
263543|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
263544|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg
263546|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
263547|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
263548|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg
263549|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
263550|NCT01349803|E4|Reported Event|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
263551|NCT01349803|E3|Reported Event|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
263552|NCT01349803|E2|Reported Event|GP MDI (PT001)|GP MDI 36 mcg
263553|NCT01349803|E1|Reported Event|FF MDI (PT005)|FF MDI 9.6 mcg
263554|NCT01349790|B1|Baseline|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
263555|NCT01349790|P1|Participant Flow|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
263556|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
263557|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
263558|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
263559|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
263560|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
263561|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
263562|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
263563|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
263564|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
263565|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
263566|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
263567|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
263568|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
263569|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
263570|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
263571|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
263572|NCT01349790|E1|Reported Event|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
263573|NCT01349660|B4|Baseline|Total|Total of all reporting groups
263574|NCT01349660|B3|Baseline|Phase II - (60 mg BKM120, 10mg/kg Bevacizumab)|"BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle.~Phase II patients include those with progressive glioblastoma multiforme"
263575|NCT01349660|B2|Baseline|Phase I - Dose Level 2 (80 mg BKM120, 10mg/kg Bevacizumab)|"BKM120: 80mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle.~Phase I patients include those diagnosed with advanced, metastatic solid tumors."
263576|NCT01349660|B1|Baseline|Phase I - Dose Level 1 (60 mg BKM, 10mg/kg Bevacizumab)|"BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle~Phase I patients include those diagnosed with advanced, metastatic solid tumors."
263577|NCT01349660|P3|Participant Flow|Phase II - (60 mg BKM120, 10mg/kg Bevacizumab)|"BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle.~Phase II patients include those with progressive glioblastoma multiforme"
263578|NCT01349660|P2|Participant Flow|Phase I - Dose Level 2 (80 mg BKM120, 10mg/kg Bevacizumab)|"BKM120: 80mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle.~Phase I patients include those diagnosed with advanced, metastatic solid tumors."
263579|NCT01349660|P1|Participant Flow|Phase I - Dose Level 1 (60 mg BKM, 10mg/kg Bevacizumab)|"BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle~Phase I patients include those diagnosed with advanced, metastatic solid tumors."
263580|NCT01349660|O3|Outcome|Phase II - (60 mg BKM120, 10mg/kg Bevacizumab)|"BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle.~Phase II patients include those with progressive glioblastoma multiforme"
263581|NCT01349660|O2|Outcome|Phase I - Dose Level 2 (80 mg BKM120, 10mg/kg Bevacizumab)|"BKM120: 80mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle.~Phase I patients include those diagnosed with advanced, metastatic solid tumors."
263582|NCT01349660|O1|Outcome|Phase I - Dose Level 1 (60 mg BKM, 10mg/kg Bevacizumab)|"BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle~Phase I patients include those diagnosed with advanced, metastatic solid tumors."
263583|NCT01349660|O2|Outcome|Phase II Participants - Bevacizumab Naive|"Phase II participants that have not received bevacizumab treatment prior to enrolling in the study.~Study treatment:~BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle."
263584|NCT01349660|O1|Outcome|Phase II Participants - Prior Bevacizumab|"Phase II participants treated with bevacizumab as part of first-line treatment prior to enrolling in the study.~Study treatment:~BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle."
263585|NCT01349660|O2|Outcome|Phase II Participants - Bevacizumab Naive|"Phase II participants that have not received bevacizumab treatment prior to enrolling in the study.~Study treatment:~BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle."
263652|NCT01349114|P2|Participant Flow|Sugar Pill/Placebo|Sugar pill/placebo arm
263653|NCT01349114|P1|Participant Flow|Aliskiren|aliskiren 300 mg daily
263586|NCT01349660|O1|Outcome|Phase II Participants - Prior Bevacizumab.|"Phase II participants treated with bevacizumab as part of first-line treatment prior to enrolling in the study.~Study treatment:~BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle."
263587|NCT01349660|O2|Outcome|Phase II Patients Without Prior Bevacizumab Treatment|"Phase II patients that had not previously been treated with bevacizumab prior to enrolling in the study.~Study treatment:~BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle."
263588|NCT01349660|O1|Outcome|Phase II Patients With Prior Bevacizumab Treatment.|"Phase II patients previously treated with bevacizumab prior to enrolling in the study.~Study treatment:~BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle."
263589|NCT01349660|O2|Outcome|Phase I Dose Level 2 (80 mg BKM120, 10mg/kg Bevacizumab)|Includes Phase I patients receiving 80mg BKM120 and 10mg/kg bevacizumab
263590|NCT01349660|O1|Outcome|Phase I Dose Level 1 (60 mg BKM120, 10mg/kg Bevacizumab)|Includes Phase I patients receiving 60 mg BKM120 and 10mg/kg bevacizumab.
263591|NCT01349660|E3|Reported Event|Phase II - (60 mg BKM120, 10mg/kg Bevacizumab)|"BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle.~Phase II patients include those with progressive glioblastoma multiforme"
263592|NCT01349660|E2|Reported Event|Phase I - Dose Level 2 (80 mg BKM120, 10mg/kg Bevacizumab)|"BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle.~Phase I patients include those diagnosed with advanced, metastatic solid tumors."
263593|NCT01349660|E1|Reported Event|Phase I - Dose Level 1 (60 mg BKM, 10mg/kg Bevacizumab)|"BKM120: 60mg by mouth (PO), once a day for each 28 day cycle. Bevacizumab: 10 mg/kg administered intravenously (IV) on Day 1 and Day 15 of each 28 day cycle~Phase I patients include those diagnosed with advanced, metastatic solid tumors."
263594|NCT01349595|B3|Baseline|Total|Total of all reporting groups
263595|NCT01349595|B2|Baseline|Standard Post-transplant Treatment|Mayo Clinic standard post kidney transplant follow-up.
263596|NCT01349595|B1|Baseline|Bortezomib|"Bortezomib is a type of targeted chemotherapy~Bortezomib: Patients randomized to bortezomib treatment will receive 2, 4-dose cycles of drug followed by a 2 month hiatus. At the end of this time, subjects will be re-evaluated for the appropriateness of receiving a 3rd and 4th cycle of bortezomib. Bortezomib will be given subcutaneously (under the skin). If unable to give subcutaneously, bortezomib will be given as a single IV (injection into vein) over a time of 3 to 5 seconds. Patients will receive up to 4, four-dose cycles of 1.3 mg/m(2) (based on body surface area)."
263597|NCT01349595|P2|Participant Flow|Standard Post-transplant Treatment|Mayo Clinic standard post kidney transplant follow-up.
263598|NCT01349595|P1|Participant Flow|Bortezomib|"Bortezomib is a type of targeted chemotherapy~Bortezomib: Patients randomized to bortezomib treatment will receive 2, 4-dose cycles of drug followed by a 2 month hiatus. At the end of this time, subjects will be re-evaluated for the appropriateness of receiving a 3rd and 4th cycle of bortezomib. Bortezomib will be given subcutaneously (under the skin). If unable to give subcutaneously, bortezomib will be given as a single IV (injection into vein) over a time of 3 to 5 seconds. Patients will receive up to 4, four-dose cycles of 1.3 mg/m(2) (based on body surface area)."
263599|NCT01349595|O2|Outcome|Standard Post-transplant Treatment|Mayo Clinic standard post kidney transplant follow-up.
263600|NCT01349595|O1|Outcome|Bortezomib|Bortezomib is a type of targeted chemotherapy
263601|NCT01349595|E2|Reported Event|Standard Post-transplant Treatment|Mayo Clinic standard post kidney transplant follow-up.
263602|NCT01349595|E1|Reported Event|Bortezomib|"Bortezomib is a type of targeted chemotherapy~Bortezomib: Patients randomized to bortezomib treatment will receive 2, 4-dose cycles of drug followed by a 2 month hiatus. At the end of this time, subjects will be re-evaluated for the appropriateness of receiving a 3rd and 4th cycle of bortezomib. Bortezomib will be given subcutaneously (under the skin). If unable to give subcutaneously, bortezomib will be given as a single IV (injection into vein) over a time of 3 to 5 seconds. Patients will receive up to 4, four-dose cycles of 1.3 mg/m(2) (based on body surface area)."
263603|NCT01349491|B3|Baseline|Total|Total of all reporting groups
263604|NCT01349491|B2|Baseline|Placebo|"Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion.~Matching placebo: Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months."
263605|NCT01349491|B1|Baseline|Ranolazine|"Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated.~Ranolazine: Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months."
263606|NCT01349491|P2|Participant Flow|Placebo|"Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion.~Matching placebo: Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months."
263607|NCT01349491|P1|Participant Flow|Ranolazine|"Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated.~Ranolazine: Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months."
263608|NCT01349491|O2|Outcome|Placebo|"Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion.~Matching placebo: Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months."
263609|NCT01349491|O1|Outcome|Ranolazine|"Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated.~Ranolazine: Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months."
263654|NCT01349114|O2|Outcome|Placebo|placebo: placebo
282607|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
263610|NCT01349491|E2|Reported Event|Placebo|"Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion.~Matching placebo: Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months."
263611|NCT01349491|E1|Reported Event|Ranolazine|"Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated.~Ranolazine: Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months."
263612|NCT01349465|B3|Baseline|Total|Total of all reporting groups
263613|NCT01349465|B2|Baseline|No SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
263614|NCT01349465|B1|Baseline|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
263615|NCT01349465|P2|Participant Flow|No SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
263616|NCT01349465|P1|Participant Flow|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
263617|NCT01349465|O1|Outcome|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
263618|NCT01349465|O1|Outcome|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
263619|NCT01349465|O2|Outcome|No SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
263620|NCT01349465|O1|Outcome|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
263621|NCT01349465|O1|Outcome|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
263622|NCT01349465|O1|Outcome|No SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
263623|NCT01349465|O1|Outcome|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
263624|NCT01349465|E3|Reported Event|Total|All Enrolled Subjects
263625|NCT01349465|E2|Reported Event|No SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
263626|NCT01349465|E1|Reported Event|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
263627|NCT01349231|B1|Baseline|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.~ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
263628|NCT01349231|P1|Participant Flow|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.~ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
263629|NCT01349231|O1|Outcome|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.~ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
263630|NCT01349231|O1|Outcome|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.~ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
263631|NCT01349231|O1|Outcome|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.~ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
263632|NCT01349231|O1|Outcome|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.~ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
263633|NCT01349231|E1|Reported Event|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.~ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
263634|NCT01349192|B3|Baseline|Total|Total of all reporting groups
263635|NCT01349192|B2|Baseline|Observational|Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
263655|NCT01349114|O1|Outcome|Aliskiren|"aliskiren 300 mg daily~aliskiren: aliskiren 300 mg daily"
263656|NCT01349114|O2|Outcome|Placebo|Sugar pill/ placebo
263657|NCT01349114|O1|Outcome|Aliskiren|aliskiren 300 mg daily
263658|NCT01349114|E2|Reported Event|Placebo|Sugar pill/ placebo
263636|NCT01349192|B1|Baseline|Treatment|"Oral antibiotics:~Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.~Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.~Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.~Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.~Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.~Topical:~Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days.~Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days.~Environmental disinfection of high use areas"
263637|NCT01349192|P2|Participant Flow|Observational|Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
263638|NCT01349192|P1|Participant Flow|Treatment|"Oral antibiotics:~Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.~Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.~Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.~Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.~Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.~Topical:~Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days.~Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days.~Environmental disinfection of high use areas"
263639|NCT01349192|O2|Outcome|Observation|Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
263640|NCT01349192|O1|Outcome|Treatment|"Oral antibiotics:~Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.~Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.~Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.~Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.~Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.~Topical:~Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days. Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days. Environmental disinfection of high use areas"
263641|NCT01349192|O2|Outcome|Observational|Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
263642|NCT01349192|O1|Outcome|Treatment|"Oral antibiotics:~Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.~Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.~Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.~Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.~Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.~Topical:~Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days.~Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days.~Environmental disinfection of high use areas"
263643|NCT01349192|O2|Outcome|Observation|Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
263644|NCT01349192|O1|Outcome|Treatment|"Oral antibiotics:~Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.~Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.~Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.~Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.~Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.~Topical:~Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days. Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days. Environmental disinfection of high use areas"
263645|NCT01349192|O2|Outcome|Observation|Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
263646|NCT01349192|O1|Outcome|Treatment|"Oral antibiotics:~Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.~Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.~Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.~Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.~Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.~Topical:~Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days. Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days. Environmental disinfection of high use areas"
263647|NCT01349192|E2|Reported Event|Observation|Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
263648|NCT01349192|E1|Reported Event|Treatment|"Oral antibiotics:~Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.~Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.~Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.~Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.~Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.~Topical:~Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days. Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days. Environmental disinfection of high use areas"
263649|NCT01349114|B3|Baseline|Total|Total of all reporting groups
263650|NCT01349114|B2|Baseline|Placebo|Sugar pill/placebo
263651|NCT01349114|B1|Baseline|Aliskiren|aliskiren 300 mg daily
263661|NCT01348854|B2|Baseline|Post Cataract With Residual Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.
263662|NCT01348854|B1|Baseline|Natural Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
263663|NCT01348854|P2|Participant Flow|Post Cataract With Residual Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.
263664|NCT01348854|P1|Participant Flow|Natural Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
263665|NCT01348854|O2|Outcome|Post Cataract With Residual Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.
263666|NCT01348854|O1|Outcome|Natural Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
263667|NCT01348854|O2|Outcome|Post Cataract With Residual Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.
263668|NCT01348854|O1|Outcome|Natural Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
263669|NCT01348854|E2|Reported Event|Post Cataract With Residual Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.
263670|NCT01348854|E1|Reported Event|Natural Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
263671|NCT01348789|B1|Baseline|Hair2Go (Mē)|Treatment with Hair2Go (Mē)device
263672|NCT01348789|P1|Participant Flow|Hair2Go (Mē)|Treatment with Hair2Go (Mē)device - 3 treatments in 2-4 day intervals
263673|NCT01348789|O1|Outcome|Hair Clearance From All Areas|Treatment with Hair2Go (Mē) device
263674|NCT01348789|O6|Outcome|Dark Skin - Treat#3|Self assessment of tolerability for skin photo-type V-VI after treatment#3
263675|NCT01348789|O5|Outcome|Dark Skin - Treat#2|Self assessment of tolerability for skin photo-type V-VI after treatment#2
263676|NCT01348789|O4|Outcome|Dark Skin - Treat#1|Self assessment of tolerability for skin photo-type V-VI after treatment#1
263677|NCT01348789|O3|Outcome|Light Skin - Treat#3|Self assessment of tolerability for skin photo-type I-IV after treatment#3.
263678|NCT01348789|O2|Outcome|Light Skin - Treat#2|Self assessment of tolerability for skin photo-type I-IV after treatment#2.
263679|NCT01348789|O1|Outcome|Light Skin - Treat#1|Self assessment of tolerability for skin photo-type I-IV after treatment#1.
263680|NCT01348789|O1|Outcome|Hair2Go (Mē)|Treatment with Hair2Go (Mē)device
263681|NCT01348789|E1|Reported Event|Hair2Go (Mē)|Treatment with Hair2Go (Mē)device
263682|NCT01348776|B1|Baseline|Hair2Go (Me)|Subjects treated with the Hair2Go (Me) Device
263683|NCT01348776|P1|Participant Flow|Hair2Go (Me)|Subjects treated with the Hair2Go (Me) Device
263684|NCT01348776|O1|Outcome|Hair2Go (Mē)|Subjects treated with the Hair2Go (Me) Device
263685|NCT01348776|O4|Outcome|Maintenance Treatment #3|Self assessment of tolerability level of procedure during 3rd maintenance treatment
263686|NCT01348776|O3|Outcome|Treatment #7|Self assessment of tolerability level of procedure during 7th treatment
263687|NCT01348776|O2|Outcome|Treatment #3|Self assessment of tolerability level of procedure during 3rd treatment
263688|NCT01348776|O1|Outcome|Treatment #1|Self assessment of tolerability level of procedure during 1st treatment
263689|NCT01348776|O1|Outcome|Anticipated Skin Effects|Anticipated skin effects included mild to moderate sense of warmth, tingling, or itching, and transient erythema and edema.
263690|NCT01348776|O2|Outcome|No Maintenance Side|Hair clearance after 7 weekly treatments without additional maintenance treatments
263691|NCT01348776|O1|Outcome|Maintenance Side|Hair clearance after 7 weekly treatments+2 additional monthly maintenance treatments
263692|NCT01348776|O2|Outcome|Hair2Go (Mē) no Maintenance Side|Subjects treated with Hair2Go (Mē) Device:the treatment areas include the side that is randomized NOT to receive maintenance treatments.
263693|NCT01348776|O1|Outcome|Hair2Go (Mē) Maintenance Side (Before Maintenance Tx)|Subjects treated with Hair2Go (Mē) Device:the treatment areas include the side that is randomized to receive maintenance treatments. This time point is before maintenance treatments were given.
263694|NCT01348776|E1|Reported Event|Hair2Go (Me)|Subjects treated with the Hair2Go (Me) Device
263695|NCT01348607|B4|Baseline|Total|Total of all reporting groups
263696|NCT01348607|B3|Baseline|Arm III Placebo|Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
263697|NCT01348607|B2|Baseline|Arm II -Modafinil|Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
263698|NCT01348607|B1|Baseline|Arm I - Methylphenidate Hydrochloride|Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
263699|NCT01348607|P3|Participant Flow|Arm III Placebo|Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
263700|NCT01348607|P2|Participant Flow|Arm II -Modafinil|Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
263765|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
263701|NCT01348607|P1|Participant Flow|Arm I - Methylphenidate Hydrochloride|Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
263702|NCT01348607|O3|Outcome|Arm III Placebo|Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
263703|NCT01348607|O2|Outcome|Arm II -Modafinil|Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
263704|NCT01348607|O1|Outcome|Arm I - Methylphenidate Hydrochloride|Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
263705|NCT01348607|O3|Outcome|Arm III Placebo|Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
263706|NCT01348607|O2|Outcome|Arm II -Modafinil|Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
263707|NCT01348607|O1|Outcome|Arm I - Methylphenidate Hydrochloride|Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
263708|NCT01348607|E3|Reported Event|Arm III Placebo|Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
263709|NCT01348607|E2|Reported Event|Arm II -Modafinil|Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
263710|NCT01348607|E1|Reported Event|Arm I - Methylphenidate Hydrochloride|Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
263711|NCT01348425|B3|Baseline|Total|Total of all reporting groups
263712|NCT01348425|B2|Baseline|Shorter Stents|Shorter Zilver PTX Stents : Treatment with Zilver PTX stents 80 mm or shorter only
263713|NCT01348425|B1|Baseline|Longer Stents|Longer Zilver PTX Stents : Treatment with at least one 100 mm or longer Zilver PTX stent
263714|NCT01348425|P2|Participant Flow|Shorter Stents|Shorter Zilver PTX Stents : Treatment with Zilver PTX stents 80 mm or shorter only
263715|NCT01348425|P1|Participant Flow|Longer Stents|Longer Zilver PTX Stents : Treatment with at least one 100 mm or longer Zilver PTX stent
263716|NCT01348425|O2|Outcome|Shorter Stents|Shorter Zilver PTX Stents : Treatment with Zilver PTX stents 80 mm or shorter only
263717|NCT01348425|O1|Outcome|Longer Stents|Longer Zilver PTX Stents : Treatment with at least one 100 mm or longer Zilver PTX stent
263718|NCT01348425|E1|Reported Event|Stented Patients|The adverse events were combined because all patients were treated with Zilver PTX stents. The safety of Zilver PTX has been previously established and the primary objective of this study was changes in post-deployment stent length; i.e. immediately post-procedure.
263719|NCT01348165|B8|Baseline|Total|Total of all reporting groups
263720|NCT01348165|B7|Baseline|0.6 mg|BI 137882 with 0.6 mg Dose level
263721|NCT01348165|B6|Baseline|0.5 mg|BI 137882 with 0.5 mg Dose level
263722|NCT01348165|B5|Baseline|0.25 mg|BI 137882 with 0.25 mg Dose level
263723|NCT01348165|B4|Baseline|0.1 mg|BI 137882 with 0.1 mg Dose level
263724|NCT01348165|B3|Baseline|0.03 mg|BI 137882 with 0.03 mg Dose level
263725|NCT01348165|B2|Baseline|0.01 mg|BI 137882 with 0.01 mg Dose level
263726|NCT01348165|B1|Baseline|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
263727|NCT01348165|P7|Participant Flow|0.6 mg|BI 137882 with 0.6 mg Dose level
263728|NCT01348165|P6|Participant Flow|0.5 mg|BI 137882 with 0.5 mg Dose level
263729|NCT01348165|P5|Participant Flow|0.25 mg|BI 137882 with 0.25 mg Dose level
263730|NCT01348165|P4|Participant Flow|0.1 mg|BI 137882 with 0.1 mg Dose level
263731|NCT01348165|P3|Participant Flow|0.03 mg|BI 137882 with 0.03 mg Dose level
263732|NCT01348165|P2|Participant Flow|0.01 mg|BI 137882 with 0.01 mg Dose level
263733|NCT01348165|P1|Participant Flow|Placebo|A solution of 0.7% sodium dodecyl sulphate (SDS) and volume depends on corresponding dose group
263734|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
263735|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
263736|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
263737|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
263738|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
263739|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
263740|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
263741|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
263742|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
263743|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
263744|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
263745|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
263746|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
263747|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
263748|NCT01348165|O6|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
263749|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
263750|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
263751|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
263752|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
263753|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
263754|NCT01348165|O6|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
263755|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
263756|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
263757|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
263758|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
263759|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
263760|NCT01348165|O6|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
263761|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
263762|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
263771|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
263772|NCT01348165|O6|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
263773|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
263774|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
263775|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
263776|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
263777|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
263778|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
263779|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
263780|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
263781|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
263782|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
263783|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
263784|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
263785|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
263786|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
263787|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
263788|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
263789|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
263790|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
263791|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
263792|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
263793|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
263794|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
263795|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
263796|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
263797|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
263798|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
263799|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
263800|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
263801|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
263802|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
263803|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
263804|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
263805|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
263806|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
263807|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
263808|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
263809|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
263810|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
263811|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
263812|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
263813|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
263814|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
263815|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
263816|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
263817|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
263818|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
263819|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
263820|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
263821|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
263822|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
263823|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
263824|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
263825|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
263826|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
263827|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
263828|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
263829|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
263830|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
263831|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
263832|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
263833|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
263834|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
263835|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
263836|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
263837|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
263838|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
263839|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
263840|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
263841|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
263842|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
263843|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
263844|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
263845|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
263846|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
263847|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
263848|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
263853|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
263854|NCT01348165|E7|Reported Event|0.6 mg|BI 137882 with 0.6 mg Dose level
263855|NCT01348165|E6|Reported Event|0.5 mg|BI 137882 with 0.5 mg Dose level
263856|NCT01348165|E5|Reported Event|0.25 mg|BI 137882 with 0.25 mg Dose level
263857|NCT01348165|E4|Reported Event|0.1 mg|BI 137882 with 0.1 mg Dose level
263858|NCT01348165|E3|Reported Event|0.03 mg|BI 137882 with 0.03 mg Dose level
263859|NCT01348165|E2|Reported Event|0.01 mg|BI 137882 with 0.01 mg Dose level
263860|NCT01348165|E1|Reported Event|Placebo|A solution of 0.7% sodium dodecyl sulphate (SDS) and volume depends on corresponding dose group
263861|NCT01348139|B1|Baseline|Baseline Total|Total number of patients randomised and treated in the study.
263862|NCT01348139|P6|Participant Flow|Placebo / 1200 μg / 1400 μg / 300 μg / 880 μg / 800 μg|Placebo followed by AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 1400 μg SID followed by AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 880 μg SID followed by AZD3199 800 μg SID.
263863|NCT01348139|P5|Participant Flow|1200 μg / 300 μg / Placebo / 800 μg / 1400 μg / 880 μg|AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 300 μg Turbuhaler inhaler followed by Placebo followed by AZD3199 800 μg SID followed by AZD3199 1400 μg SID followed by AZD3199 880 μg SID.
263864|NCT01348139|P4|Participant Flow|300 μg / 800 μg / 1200 μg / 880 μg / Placebo / 1400 μg|AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 800 μg SID followed by AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 880 μg SID followed by Placebo followed by AZD3199 1400 μg SID.
263865|NCT01348139|P3|Participant Flow|800 μg / 880 μg / 300 μg / 1400 μg / 1200 μg / Placebo|AZD3199 800 μg SID followed by AZD3199 880 μg SID followed by AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 1400 μg SID followed by AZD3199 1200 μg Turbuhaler inhaler followed by Placebo.
263866|NCT01348139|P2|Participant Flow|880 μg / 1400 μg / 800 μg / Placebo / 300 μg / 1200 μg|AZD3199 880 μg SID followed by AZD3199 1400 μg SID followed by AZD3199 800 μg SID followed by Placebo followed by AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 1200 μg Turbuhaler inhaler.
263867|NCT01348139|P1|Participant Flow|1400 μg / Placebo / 880 μg / 1200 μg / 800 μg / 300 μg|AZD3199 1400 μg SID followed by Placebo followed by AZD3199 880 μg SID followed by AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 800 μg SID followed by AZD3199 300 μg Turbuhaler inhaler.
263868|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
263869|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
263870|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
263871|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
263872|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
263873|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
263874|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
263875|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
263876|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
263877|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
263878|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
263879|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
263880|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
263881|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
263882|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
263883|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
263884|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
263885|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
263886|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
263887|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
263888|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
263889|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
263890|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
263891|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
263892|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
263893|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
263894|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
263895|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
263896|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
263897|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
263898|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
263899|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
263900|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
263901|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
263902|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
263903|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
263904|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
263905|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
263906|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
263907|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
263908|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
263909|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
263910|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
263911|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
263912|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
263913|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
263914|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
263915|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
263916|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
263917|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
263918|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
263919|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
263920|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
263921|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
263922|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
263923|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
263924|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
263925|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
263926|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
263927|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
263928|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
263929|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
263930|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
263931|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
263932|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
263933|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
263934|NCT01348139|E6|Reported Event|Placebo|Placebo
263935|NCT01348139|E5|Reported Event|AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
263936|NCT01348139|E4|Reported Event|AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
263937|NCT01348139|E3|Reported Event|AZD3199 800 μg|AZD3199 800 μg SID
263938|NCT01348139|E2|Reported Event|AZD3199 880 μg|AZD3199 880 μg SID
263939|NCT01348139|E1|Reported Event|AZD3199 1400 μg|AZD3199 1400 μg SID
263940|NCT01348100|B8|Baseline|Total|Total of all reporting groups
263941|NCT01348100|B7|Baseline|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263942|NCT01348100|B6|Baseline|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263943|NCT01348100|B5|Baseline|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263944|NCT01348100|B4|Baseline|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263945|NCT01348100|B3|Baseline|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263946|NCT01348100|B2|Baseline|Iloperidone 125 mg Crystalline Formulation - Phase A|Participants received a crystalline formulation of iloperidone 125 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
263947|NCT01348100|B1|Baseline|Iloperidone 50 mg Crystalline Formulation - Phase A|Participants received a crystalline formulation of iloperidone 50 mg in a depot intramuscular (IM) injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
263948|NCT01348100|P7|Participant Flow|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263949|NCT01348100|P6|Participant Flow|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263950|NCT01348100|P5|Participant Flow|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263951|NCT01348100|P4|Participant Flow|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263952|NCT01348100|P3|Participant Flow|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263953|NCT01348100|P2|Participant Flow|Iloperidone 125 mg Crystalline Formulation - Phase A|Participants received a crystalline formulation of iloperidone 125 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
263954|NCT01348100|P1|Participant Flow|Iloperidone 50 mg Crystalline Formulation - Phase A|Participants received a crystalline formulation of iloperidone 50 mg in a depot intramuscular (IM) injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
264011|NCT01348087|E1|Reported Event|Prior to Ext.First Dose|Prior to Ext.first dose
263955|NCT01348100|O3|Outcome|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263956|NCT01348100|O2|Outcome|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263957|NCT01348100|O1|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263958|NCT01348100|O3|Outcome|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263959|NCT01348100|O2|Outcome|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263960|NCT01348100|O1|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263961|NCT01348100|O3|Outcome|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263962|NCT01348100|O2|Outcome|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263963|NCT01348100|O1|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263964|NCT01348100|O3|Outcome|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263965|NCT01348100|O2|Outcome|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263966|NCT01348100|O1|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263967|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263968|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263969|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263970|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263971|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263972|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263973|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263974|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
264012|NCT01347931|B1|Baseline|Overall Study Group|All subjects participating in 2-way crossover design study
264046|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
263975|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263976|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263977|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263978|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263979|NCT01348100|O3|Outcome|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263980|NCT01348100|O2|Outcome|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263981|NCT01348100|O1|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263982|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263983|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263984|NCT01348100|E14|Reported Event|Iloperidone 625 mg Microparticle Formulation - Phase C Depot|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart.
263985|NCT01348100|E13|Reported Event|Iloperidone 500 mg Microparticle Formulation - Phase C Depot|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart.
263986|NCT01348100|E12|Reported Event|Iloperidone 250 mg Microparticle Formulation - Phase C Depot|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart.
263987|NCT01348100|E11|Reported Event|Iloperidone 625 mg Microparticle Formulation - Phase C Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263988|NCT01348100|E10|Reported Event|Iloperidone 500 mg Microparticle Formulation - Phase C Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263989|NCT01348100|E9|Reported Event|Iloperidone 250 mg Microparticle Formulation - Phase C Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263990|NCT01348100|E8|Reported Event|Iloperidone 250 mg Microparticle Formulation - Phase B Depot|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time.
263991|NCT01348100|E7|Reported Event|Iloperidone 250 mg Crystalline Formulation - Phase B Depot|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time.
263992|NCT01348100|E6|Reported Event|Iloperidone 250 mg Microparticle Formulation - Phase B Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263993|NCT01348100|E5|Reported Event|Iloperidone 250 mg Crystalline Formulation - Phase B Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
263994|NCT01348100|E4|Reported Event|Iloperidone 125 mg Crystalline Formulation - Phase A Depot|Participants received a crystalline formulation of iloperidone 125 mg in a depot IM injection 1 time.
263995|NCT01348100|E3|Reported Event|Iloperidone 50 mg Crystalline Formulation - Phase A Depot|Participants received a crystalline formulation of iloperidone 50 mg in a depot intramuscular (IM) injection 1 time.
263996|NCT01348100|E2|Reported Event|Iloperidone 125 mg Crystalline Formulation - Phase A Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
263997|NCT01348100|E1|Reported Event|Iloperidone 50 mg Crystalline Formulation - Phase A Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
263998|NCT01348087|B1|Baseline|AFQ056|Participants from a previous AFQ056 study who entered the open-label extension study were administered AFQ056 capsules at a starting dose of 25 milligram (mg) twice daily (bid) and then titrated to 50 mg bid, 75 mg bid and 100 mg bid at weekly intervals
263999|NCT01348087|P1|Participant Flow|AFQ056 Total|Participants from a previous AFQ056 study who entered the open-label extension study were administered AFQ056 capsules at a starting dose of 25 milligram (mg) twice daily (bid) and then titrated to 50 mg bid, 75 mg bid and 100 mg bid at weekly intervals
264000|NCT01348087|O6|Outcome|AFQ056 Total|
264013|NCT01347931|P1|Participant Flow|Standard Oxygen Therapy|"Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.~Breathe NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
264014|NCT01347931|O2|Outcome|Breathe NIOV System|"Noninvasive ventilation delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
264015|NCT01347931|O1|Outcome|Standard Oxygen Therapy|"Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
264016|NCT01347931|O2|Outcome|Breathe NIOV System|"Noninvasive ventilation delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
264017|NCT01347931|O1|Outcome|Standard Oxygen Therapy|"Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
264018|NCT01347931|O2|Outcome|Breathe NIOV System|"Noninvasive ventilation delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
264019|NCT01347931|O1|Outcome|Standard Oxygen Therapy|"Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
264020|NCT01347931|E2|Reported Event|Breathe NIOV System|"Noninvasive ventilation delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
264021|NCT01347931|E1|Reported Event|Standard Oxygen Therapy|"Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
264022|NCT01347879|B3|Baseline|Total|Total of all reporting groups
264023|NCT01347879|B2|Baseline|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
264024|NCT01347879|B1|Baseline|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
264025|NCT01347879|P2|Participant Flow|Visonac Cream With PDT|"active treatment with light dose of 37 J/cm2~Visonac photodynamic therapy (PDT): cream application prior to illumination with red light"
264026|NCT01347879|P1|Participant Flow|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
264027|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
264028|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
264029|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
264030|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
264031|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
264032|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
264033|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
264034|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
264035|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
264036|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
264037|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
264038|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
264039|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
264040|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
264041|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
264042|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
264043|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
264044|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
264045|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
282608|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
264047|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
264048|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
264049|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
264050|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
264051|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
264052|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
264053|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
264054|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
264055|NCT01347879|E2|Reported Event|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
264056|NCT01347879|E1|Reported Event|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
264057|NCT01347840|B1|Baseline|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
264058|NCT01347840|P1|Participant Flow|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
264059|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
264060|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
264061|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
264062|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
264063|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
264064|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
264065|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
264066|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
264067|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
264068|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
264069|NCT01347840|E1|Reported Event|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
264070|NCT01347788|B1|Baseline|Cabozantinib|"Final results have been published Clin Cancer Res. 2013 Jun 1;19(11):3088-94. doi: 10.1158/1078-0432.CCR-13-0319. Epub 2013 Apr 3.~A dose-ranging study of cabozantinib in men with castration-resistant prostate cancer and bone metastases.~Lee RJ, Saylor PJ, Michaelson MD, Rothenberg SM, Smas ME, Miyamoto DT, Gurski CA, Xie W, Maheswaran S, Haber DA, Goldin JG, Smith MR.~Author information Massachusetts General Hospital Cancer Center, Boston, Massachusetts 02114, USA. rjlee@partners.org"
264071|NCT01347788|P3|Participant Flow|Expansion Cohort|Cabozantinib 40 mg daily
264072|NCT01347788|P2|Participant Flow|Dose Level -1|Cabozantinib 20 mg daily
264073|NCT01347788|P1|Participant Flow|Dose Level 0|Cabozantinib 40 mg daily
264074|NCT01347788|O3|Outcome|Expansion Cohort|Dose level 0: cabozantinib 40 mg daily
264075|NCT01347788|O2|Outcome|Cohort 2|Dose level -1: cabozantinib 20 mg daily
264076|NCT01347788|O1|Outcome|Cohort 1|Dose level 0: cabozantinib 40 mg daily
264077|NCT01347788|E3|Reported Event|Cohort 3|Dose level 0: cabozantinib 40 mg daily
264078|NCT01347788|E2|Reported Event|Cohort 2|Dose level -1: cabozantinib 20 mg daily
264079|NCT01347788|E1|Reported Event|Cohort 1|Dose level 0: cabozantinib 40 mg daily
264080|NCT01347710|B1|Baseline|Flurpiridaz F 18|Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
264081|NCT01347710|P1|Participant Flow|Flurpiridaz F 18|Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
264082|NCT01347710|O1|Outcome|Flurpiridaz F 18|Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
264083|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
264084|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
264085|NCT01347710|O1|Outcome|Flurpiridaz F18|"Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
264086|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis
264087|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
264088|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
264089|NCT01347710|O1|Outcome|Flurpiridaz F 18|Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
264090|NCT01347710|O1|Outcome|Flurpiridaz F 18|Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
264091|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
264092|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
264093|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
264094|NCT01347710|E1|Reported Event|Flurpiridaz F 18|Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
264095|NCT01347632|B1|Baseline|Metronidazole|Open Label Study
264096|NCT01347632|P1|Participant Flow|Metronidazole|Open Label Study
264097|NCT01347632|O1|Outcome|Metronidazole|Open Label Study
264098|NCT01347632|O1|Outcome|Metronidazole|Open Label Study
264099|NCT01347632|E1|Reported Event|Metronidazole|Open Label Study
264100|NCT01347580|B3|Baseline|Total|Total of all reporting groups
264101|NCT01347580|B2|Baseline|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264102|NCT01347580|B1|Baseline|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264103|NCT01347580|P2|Participant Flow|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264104|NCT01347580|P1|Participant Flow|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264105|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264106|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264107|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264108|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264109|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264110|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264111|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264112|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264113|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264114|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264115|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264116|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264117|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264118|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264119|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264120|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264121|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264122|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264123|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264124|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264125|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264126|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264127|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264128|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264129|NCT01347580|E2|Reported Event|Ticagrelor Pre-Hosp|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264130|NCT01347580|E1|Reported Event|Ticagrelor In-Hosp|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
264131|NCT01347554|B3|Baseline|Total|Total of all reporting groups
264132|NCT01347554|B2|Baseline|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
264133|NCT01347554|B1|Baseline|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
264134|NCT01347554|P2|Participant Flow|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
264135|NCT01347554|P1|Participant Flow|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
264136|NCT01347554|O2|Outcome|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
264137|NCT01347554|O1|Outcome|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
264138|NCT01347554|O2|Outcome|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
264139|NCT01347554|O1|Outcome|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
264140|NCT01347554|O2|Outcome|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
264141|NCT01347554|O1|Outcome|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
264142|NCT01347554|O2|Outcome|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
264143|NCT01347554|O1|Outcome|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
264144|NCT01347554|E2|Reported Event|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
264145|NCT01347554|E1|Reported Event|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
264146|NCT01347255|B1|Baseline|LEO 90100 Cutaneous Spray, Ointment|"Intra-Individual baseline analysis population, all treated with the following four products:~LEO 90100 cutaneous spray, ointment: once daily application, 4 weeks (6 days a week)~LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate: once daily application, 4 weeks (6 days a week)~LEO 90100 cutaneous spray, ointment, vehicle: once daily application, 4 weeks (6 days a week)~Daivobet® ointment: once daily application, 4 weeks (6 days a week)"
264147|NCT01347255|P1|Participant Flow|All Study Participants|"All subjects received all four treatments:~LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)~LEO 90100 cutaneous spray, ointment, vehicle w. betamethasone. Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)~LEO 90100 cutaneous spray, ointment, vehicle. Served as a negative control for the two cutaneous spray ointments with active ingredients~Daivobet® ointment. Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)~Four test sites of approximately 5 cm2 were selected on predetermined psoriasis lesions (target plaques), delimited with a disposable circular device and mapped on a drawn figure.~The distance between two test sites was at least 2 cm. The products were applied on the four test sites (according to random assignment to specific test sites selected on the psoriasis plaque) once daily 6 days a week (except Sundays) for 4 weeks."
264148|NCT01347255|O4|Outcome|Daivobet® Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
264149|NCT01347255|O3|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle|LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
264150|NCT01347255|O2|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone|Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
264151|NCT01347255|O1|Outcome|LEO 90100 Cutaneous Spray, Ointment|LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
264152|NCT01347255|O4|Outcome|Daivobet® Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
264877|NCT01345591|O1|Outcome|Fat Graft Volume at 3 Months|fat grafting for facial trauma, volume measured at 3 months post-op
264153|NCT01347255|O3|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle|LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
264154|NCT01347255|O2|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone|Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
264155|NCT01347255|O1|Outcome|LEO 90100 Cutaneous Spray, Ointment|LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
264156|NCT01347255|O4|Outcome|Daivobet® Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
264157|NCT01347255|O3|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle|LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
264158|NCT01347255|O2|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone|Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
264159|NCT01347255|O1|Outcome|LEO 90100 Cutaneous Spray, Ointment|LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
264160|NCT01347255|O4|Outcome|Daivobet® Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
264161|NCT01347255|O3|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle|LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
264162|NCT01347255|O2|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone|Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
264163|NCT01347255|O1|Outcome|LEO 90100 Cutaneous Spray, Ointment|LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
264164|NCT01347255|O4|Outcome|Daivobet® Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
264165|NCT01347255|O3|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle|LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
264166|NCT01347255|O2|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone|Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
264167|NCT01347255|O1|Outcome|LEO 90100 Cutaneous Spray, Ointment|LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
264168|NCT01347255|E1|Reported Event|LEO 90100 Cutaneous Spray, Ointment|"Intra-Individual baseline analysis population, all treated with the following four products:~LEO 90100 cutaneous spray, ointment: once daily application, 4weeks~LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate: once daily application, 4 weeks~LEO 90100 cutaneous spray, ointment, vehicle: once daily application, 4weeks~Daivobet® ointment: once daily application, 4weeks"
264169|NCT01347112|B3|Baseline|Total|Total of all reporting groups
264170|NCT01347112|B2|Baseline|Sugar Pill|"Varenicline look alike sugar pill twice daily for 12 weeks~placebo: sugar pill twice daily for 12 weeks"
264171|NCT01347112|B1|Baseline|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks~Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
264172|NCT01347112|P2|Participant Flow|Sugar Pill|"Varenicline look alike sugar pill twice daily for 12 weeks~placebo: sugar pill twice daily for 12 weeks"
264173|NCT01347112|P1|Participant Flow|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks~Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
264174|NCT01347112|O2|Outcome|Sugar Pill|"Varenicline look alike sugar pill twice daily for 12 weeks~placebo: sugar pill twice daily for 12 weeks"
264175|NCT01347112|O1|Outcome|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks~Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
264176|NCT01347112|O2|Outcome|Sugar Pil|"Varenicline look alike sugar pill twice daily for 12 weeks~placebo: sugar pill twice daily for 12 weeks"
264177|NCT01347112|O1|Outcome|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks~Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
264178|NCT01347112|O2|Outcome|Sugar Pil|"Varenicline look alike sugar pill twice daily for 12 weeks~placebo: sugar pill twice daily for 12 weeks"
264179|NCT01347112|O1|Outcome|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks~Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
264180|NCT01347112|E2|Reported Event|Sugar Pill|"Varenicline look alike sugar pill twice daily for 12 weeks~placebo: sugar pill twice daily for 12 weeks"
264181|NCT01347112|E1|Reported Event|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks~Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
264182|NCT01347086|B11|Baseline|Total|Total of all reporting groups
264183|NCT01347086|B10|Baseline|Placebo (Chinese Subjects)|"Chinese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
264184|NCT01347086|B9|Baseline|1200 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264185|NCT01347086|B8|Baseline|800 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264186|NCT01347086|B7|Baseline|400 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264187|NCT01347086|B6|Baseline|Placebo (Japanese Subjects)|"Japanese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
264188|NCT01347086|B5|Baseline|1200mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264189|NCT01347086|B4|Baseline|800 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264190|NCT01347086|B3|Baseline|400 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264191|NCT01347086|B2|Baseline|Placebo (Caucasian Subjects)|"Caucasian subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
264192|NCT01347086|B1|Baseline|1200 mg Deleobuvir (Caucasian Subjects)|"Caucasian subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264193|NCT01347086|P10|Participant Flow|1200 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264194|NCT01347086|P9|Participant Flow|800 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264195|NCT01347086|P8|Participant Flow|400 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264196|NCT01347086|P7|Participant Flow|Placebo (Chinese Subjects)|"Chinese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
264197|NCT01347086|P6|Participant Flow|1200mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264198|NCT01347086|P5|Participant Flow|800 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264199|NCT01347086|P4|Participant Flow|400 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264200|NCT01347086|P3|Participant Flow|Placebo (Japanese Subjects)|"Japanese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
264201|NCT01347086|P2|Participant Flow|1200 mg Deleobuvir (Caucasian Subjects)|"Caucasian subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264202|NCT01347086|P1|Participant Flow|Placebo (Caucasian Subjects)|"Caucasian subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
264203|NCT01347086|O6|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264204|NCT01347086|O5|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264205|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264206|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264207|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264208|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264209|NCT01347086|O6|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264210|NCT01347086|O5|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264211|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264212|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264213|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264214|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264215|NCT01347086|O3|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264216|NCT01347086|O2|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264217|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264218|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264219|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264220|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264221|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264222|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264223|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264224|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264225|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264226|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264227|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264228|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264229|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264230|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264231|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264232|NCT01347086|O5|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264233|NCT01347086|O4|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264234|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264235|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264236|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264237|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264238|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264239|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264240|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264241|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264242|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264243|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264244|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264245|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264246|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264247|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264248|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264249|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264250|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264251|NCT01347086|O4|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264252|NCT01347086|O3|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264253|NCT01347086|O2|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264254|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264255|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264256|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264257|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264258|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264259|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264260|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264261|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264262|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264263|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264264|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264265|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264266|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264267|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264268|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264269|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264270|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264271|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264272|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264273|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264274|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264275|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264276|NCT01347086|O10|Outcome|Placebo (Chinese Subjects)|"Chinese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
264277|NCT01347086|O9|Outcome|1200 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264278|NCT01347086|O8|Outcome|800 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264279|NCT01347086|O7|Outcome|400 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264280|NCT01347086|O6|Outcome|Placebo (Japanese Subjects)|"Japanese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
264281|NCT01347086|O5|Outcome|1200mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264282|NCT01347086|O4|Outcome|800 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264283|NCT01347086|O3|Outcome|400 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264284|NCT01347086|O2|Outcome|Placebo (Caucasian Subjects)|"Caucasian subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
264285|NCT01347086|O1|Outcome|1200 mg Deleobuvir (Caucasian Subjects)|"Caucasian subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264286|NCT01347086|O10|Outcome|Placebo (Chinese Subjects)|"Chinese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
264287|NCT01347086|O9|Outcome|1200 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264288|NCT01347086|O8|Outcome|800 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264289|NCT01347086|O7|Outcome|400 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264290|NCT01347086|O6|Outcome|Placebo (Japanese Subjects)|"Japanese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
264291|NCT01347086|O5|Outcome|1200mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264292|NCT01347086|O4|Outcome|800 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264293|NCT01347086|O3|Outcome|400 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264294|NCT01347086|O2|Outcome|Placebo (Caucasian Subjects)|"Caucasian subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
264295|NCT01347086|O1|Outcome|1200 mg Deleobuvir (Caucasian Subjects)|"Caucasian subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
264296|NCT01347086|E4|Reported Event|1200 mg Deleobuvir|All (Caucasian, Japanese and Chinese) subjects that received 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition.
264297|NCT01347086|E3|Reported Event|800 mg Deleobuvir|All (Japanese and Chinese) subjects that received 800 mg Deleobuvir. Oral with 240 mL of water in fed condition.
264298|NCT01347086|E2|Reported Event|400 mg Deleobuvir|All (Japanese and Chinese) subjects that received 400 mg Deleobuvir. Oral with 240 mL of water in fed condition.
264299|NCT01347086|E1|Reported Event|Placebo|All (Caucasian, Japanese and Chinese) subjects that received matching placebo. Oral with 240 mL of water in fed condition.
264300|NCT01347073|B1|Baseline|HPN-100|The first part of this open-label study consisted of a switch-over period during which patients were switched from the current medication (NaPBA) to HPN-100. The second part of this open-label study consisted of a 12-month long-term treatment phase with HPN-100. All participants in the switch-over were enrolled into the long-term treatment phase.
264301|NCT01347073|P1|Participant Flow|HPN-100|The first part of this open-label study consisted of a switch-over period during which patients were switched from the current medication (NaPBA) to HPN-100. The second part of this open-label study consisted of a 12-month long-term treatment phase with HPN-100. All participants in the switch-over were enrolled into the long-term treatment phase.
264302|NCT01347073|O1|Outcome|HPN-100|Long Term Treatment
264303|NCT01347073|O2|Outcome|Long-term Phase|The second part of this open-label study consisted of a 12-month long-term treatment phase with HPN-100. All participants in the switch-over were enrolled into the long-term treatment phase.
264304|NCT01347073|O1|Outcome|Pre-enrollment|12-months preceding the study
264305|NCT01347073|O2|Outcome|HPN-100|Switch Over and Long Term Treatment
264306|NCT01347073|O1|Outcome|NaPBA|Switch Over
264307|NCT01347073|O2|Outcome|HPN-100|Switch Over and Long Term Treatment
264308|NCT01347073|O1|Outcome|NaPBA|Switch Over
264309|NCT01347073|O2|Outcome|HPN-100|Switch Over and Long Term Treatment Arm
264310|NCT01347073|O1|Outcome|NaPBA|Switch Over Arm
264311|NCT01347073|E1|Reported Event|HPN-100|The first part of this open-label study consisted of a switch-over period during which patients were switched from the current medication (NaPBA) to HPN-100. The second part of this open-label study consisted of a 12-month long-term treatment phase with HPN-100. All participants in the switch-over were enrolled into the long-term treatment phase.
264312|NCT01347060|B3|Baseline|Total|Total of all reporting groups
264313|NCT01347060|B2|Baseline|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
264314|NCT01347060|B1|Baseline|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
264315|NCT01347060|P2|Participant Flow|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
264316|NCT01347060|P1|Participant Flow|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
264317|NCT01347060|O2|Outcome|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
282609|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
264318|NCT01347060|O1|Outcome|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
264319|NCT01347060|O2|Outcome|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
264320|NCT01347060|O1|Outcome|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
264321|NCT01347060|O2|Outcome|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
264322|NCT01347060|O1|Outcome|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
264323|NCT01347060|E2|Reported Event|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
264324|NCT01347060|E1|Reported Event|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
264325|NCT01347034|B3|Baseline|Total|Total of all reporting groups
264326|NCT01347034|B2|Baseline|Experimental: External Beam RT + DC Injection|Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
264327|NCT01347034|B1|Baseline|Active Comparator: External Beam Radiation Therapy (RT)|Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description
264328|NCT01347034|P2|Participant Flow|Experimental: External Beam RT + DC Injection|Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
264329|NCT01347034|P1|Participant Flow|Active Comparator: External Beam Radiation Therapy (RT)|Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description
264330|NCT01347034|O2|Outcome|Experimental: External Beam RT + DC Injection|Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
264331|NCT01347034|O1|Outcome|Active Comparator: External Beam Radiation Therapy (RT)|Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description
264332|NCT01347034|O2|Outcome|Experimental: External Beam RT + DC Injection|Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
264333|NCT01347034|O1|Outcome|Active Comparator: External Beam Radiation Therapy (RT)|Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description
264334|NCT01347034|E2|Reported Event|Experimental: External Beam RT + DC Injection|Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
264335|NCT01347034|E1|Reported Event|Active Comparator: External Beam Radiation Therapy (RT)|Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description
264336|NCT01347008|B3|Baseline|Total|Total of all reporting groups
264337|NCT01347008|B2|Baseline|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
264338|NCT01347008|B1|Baseline|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.~Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
264339|NCT01347008|P2|Participant Flow|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
264340|NCT01347008|P1|Participant Flow|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.~Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
264341|NCT01347008|O2|Outcome|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
264342|NCT01347008|O1|Outcome|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.~Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
264343|NCT01347008|O2|Outcome|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
264344|NCT01347008|O1|Outcome|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.~Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
264345|NCT01347008|O2|Outcome|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
264346|NCT01347008|O1|Outcome|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.~Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
264347|NCT01347008|E2|Reported Event|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
264348|NCT01347008|E1|Reported Event|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.~Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
264349|NCT01346852|B3|Baseline|Total|Total of all reporting groups
264391|NCT01346592|P2|Participant Flow|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264878|NCT01345591|E1|Reported Event|Fat Grafting|fat grafting for facial trauma
264350|NCT01346852|B2|Baseline|Adult Participants Diagnosed With Asthma|Adult (>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
264351|NCT01346852|B1|Baseline|Pediatric Participants Diagnosed With Asthma|Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
264352|NCT01346852|P2|Participant Flow|Adult Participants Diagnosed With Asthma|Adult (>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
264353|NCT01346852|P1|Participant Flow|Pediatric Participants Diagnosed With Asthma|Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
264354|NCT01346852|O2|Outcome|Adult Participants Diagnosed With Asthma|Adult (>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
264355|NCT01346852|O1|Outcome|Pediatric Participants Diagnosed With Asthma|Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
264356|NCT01346852|O2|Outcome|Adult Participants Diagnosed With Asthma|Adult (>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
264357|NCT01346852|O1|Outcome|Pediatric Participants Diagnosed With Asthma|Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
264358|NCT01346852|E2|Reported Event|Adult Participants Diagnosed With Asthma|Adult (>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
264359|NCT01346852|E1|Reported Event|Pediatric Participants Diagnosed With Asthma|Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
264360|NCT01346839|B3|Baseline|Total|Total of all reporting groups
264361|NCT01346839|B2|Baseline|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
264362|NCT01346839|B1|Baseline|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
264539|NCT01346475|P2|Participant Flow|High-dose Valacyclovir First Then Standard-dose Valacyclovir|High-dose valacyclovir (1 gram three times daily) for 5 weeks followed by 1 week wash-out and then standard-dose valacyclovir (500 mg daily) for 5 weeks
264363|NCT01346839|P2|Participant Flow|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
264364|NCT01346839|P1|Participant Flow|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
264365|NCT01346839|O2|Outcome|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
264366|NCT01346839|O1|Outcome|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
264367|NCT01346839|O2|Outcome|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
264368|NCT01346839|O1|Outcome|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
264369|NCT01346839|O2|Outcome|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
264370|NCT01346839|O1|Outcome|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
264392|NCT01346592|P1|Participant Flow|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264393|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264608|NCT01346189|O4|Outcome|Usual Care|
282645|NCT01292642|O1|Outcome|Baseline - Cigarettes Per Day|
264371|NCT01346839|O2|Outcome|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
264372|NCT01346839|O1|Outcome|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
264373|NCT01346839|O2|Outcome|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
264374|NCT01346839|O1|Outcome|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
264375|NCT01346839|E2|Reported Event|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
264376|NCT01346839|E1|Reported Event|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
264377|NCT01346774|B3|Baseline|Total|Total of all reporting groups
264378|NCT01346774|B2|Baseline|Placebo|Placebo powder: 2 placebo powder capsules twice a day
264379|NCT01346774|B1|Baseline|Cranberry Capsules|Cranberry powder: 2 cranberry powder capsules twice a day
264380|NCT01346774|P2|Participant Flow|Placebo|Placebo powder: 2 placebo powder capsules twice a day
264381|NCT01346774|P1|Participant Flow|Cranberry Capsules|Cranberry powder: 2 cranberry powder capsules twice a day
264382|NCT01346774|O2|Outcome|Placebo|Placebo powder: 2 placebo powder capsules twice a day
264383|NCT01346774|O1|Outcome|Cranberry Capsules|Cranberry powder: 2 cranberry powder capsules twice a day
264384|NCT01346774|E2|Reported Event|Placebo Capsules|Placebo powder: 2 placebo powder capsules twice a day
264385|NCT01346774|E1|Reported Event|Cranberry Capsules|Cranberry powder: 2 cranberry powder capsules twice a day
264386|NCT01346592|B4|Baseline|Total|Total of all reporting groups
264387|NCT01346592|B3|Baseline|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264388|NCT01346592|B2|Baseline|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264389|NCT01346592|B1|Baseline|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264390|NCT01346592|P3|Participant Flow|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264394|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264395|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264396|NCT01346592|O3|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264397|NCT01346592|O2|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264398|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264399|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264400|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264401|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264402|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264403|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264404|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264405|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264406|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264407|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264408|NCT01346592|O9|Outcome|TIV (36 to <72 Months)|Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
264409|NCT01346592|O8|Outcome|Comparator TIV (36 to <72 Months)|Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
264410|NCT01346592|O7|Outcome|aTIV (36 to <72 Months)|Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
264411|NCT01346592|O6|Outcome|TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational trivalent split influenza vaccine (TIV)
264412|NCT01346592|O5|Outcome|Compartor TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
264413|NCT01346592|O4|Outcome|aTIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
264414|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine
264415|NCT01346592|O2|Outcome|Compartor TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
264416|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
264417|NCT01346592|O9|Outcome|TIV (36 to <72 Months)|Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
264418|NCT01346592|O8|Outcome|Comparator TIV (36 to <72 Months)|Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
264419|NCT01346592|O7|Outcome|aTIV (36 to <72 Months)|Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
264420|NCT01346592|O6|Outcome|TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational trivalent split influenza vaccine (TIV)
264421|NCT01346592|O5|Outcome|Compartor TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
264422|NCT01346592|O4|Outcome|aTIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
264666|NCT01345929|O2|Outcome|Levofloxacin as Treatment for cUTI|"Levofloxacin IV infusion (750mg qd) for 7 days~Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days"
264423|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine
264424|NCT01346592|O2|Outcome|Compartor TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
264425|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
264426|NCT01346592|O9|Outcome|TIV (36 to <72 Months)|Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
264427|NCT01346592|O8|Outcome|Comparator TIV (36 to <72 Months)|Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
264428|NCT01346592|O7|Outcome|aTIV (36 to <72 Months)|Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
264429|NCT01346592|O6|Outcome|TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational trivalent split influenza vaccine (TIV)
264430|NCT01346592|O5|Outcome|Compartor TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
264431|NCT01346592|O4|Outcome|aTIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
264432|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine
264433|NCT01346592|O2|Outcome|Compartor TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
264434|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
264435|NCT01346592|O9|Outcome|TIV (36 to <72 Months)|Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
264436|NCT01346592|O8|Outcome|Comparator TIV (36 to <72 Months)|Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
264437|NCT01346592|O7|Outcome|aTIV (36 to <72 Months)|Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
264438|NCT01346592|O6|Outcome|TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational trivalent split influenza vaccine (TIV)
264439|NCT01346592|O5|Outcome|Compartor TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
264440|NCT01346592|O4|Outcome|aTIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
264441|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine
264442|NCT01346592|O2|Outcome|Compartor TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
264443|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
264444|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264445|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264446|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264447|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264448|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264449|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264450|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264451|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264514|NCT01346501|O1|Outcome|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
264452|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264453|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264454|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264455|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264456|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264457|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264458|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264459|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264460|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264461|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264462|NCT01346592|O3|Outcome|TIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the investigational trivalent split influenza vaccine (TIV), at Days 1 & 29
264463|NCT01346592|O2|Outcome|Comparator TIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the licensed comparator trivalent split influenza vaccine (comparator TIV), at Days 1 & 29
264464|NCT01346592|O1|Outcome|aTIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the investigational MF59-adjuvanted trivalent split influenza vaccine (aTIV), at Days 1 & 29
264465|NCT01346592|O3|Outcome|TIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the investigational trivalent split influenza vaccine (TIV), at Days 1 & 29
264466|NCT01346592|O2|Outcome|Comparator TIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the licensed comparator trivalent split influenza vaccine (comparator TIV), at Days 1 & 29
264467|NCT01346592|O1|Outcome|aTIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the investigational MF59-adjuvanted trivalent split influenza vaccine (aTIV), at Days 1 & 29
264468|NCT01346592|O2|Outcome|Comparator TIV (6 to <36months)|Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 & 29
264469|NCT01346592|O1|Outcome|TIV (6 to <36months)|Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 & 29
264470|NCT01346592|O2|Outcome|Comparator TIV (6 to <36months)|Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 & 29
264471|NCT01346592|O1|Outcome|TIV (6 to <36months)|Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 & 29
264472|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264473|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264474|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264475|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine
264476|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
264477|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
264478|NCT01346592|E3|Reported Event|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264479|NCT01346592|E2|Reported Event|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264480|NCT01346592|E1|Reported Event|ATIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
264481|NCT01346514|B3|Baseline|Total|Total of all reporting groups
264482|NCT01346514|B2|Baseline|Arm 2/Housing Support Group (HSG)|HSG/ The Housing Support Group is a time and attention control. Veterans assigned to HSG attend a weekly drop-in housing group where housing options are discussed and participants receive support from one another.
264483|NCT01346514|B1|Baseline|Arm 1/Addiction Housing Case Management (AHCM)|AHCM intervention/ AHCM involves intensive case management for housing, substance use, and related issues. Veterans assigned to the AHCM condition will have a case manager who is integrated with the interdisciplinary treatment team. The AHCM will meet with the Veteran weekly, assist the Veteran with potential housing options, support the Veteran in continuing addiction treatment and psychiatric care, visit the Veteran in the community when appropriate, and obtain point of care urine toxicology testing to assess abstinence with the goal of addressing substance use issues proactively. The AHCM will educate the Veteran on needed basic life skills using existing manuals
264484|NCT01346514|P2|Participant Flow|Arm 2/Housing Support Group (HSG)|HSG/ The Housing Support Group is a time and attention control. Veterans assigned to HSG attend a weekly drop-in housing group where housing options are discussed and participants receive support from one another.
264485|NCT01346514|P1|Participant Flow|Arm 1/Addiction Housing Case Management (AHCM)|AHCM intervention/ AHCM involves intensive case management for housing, substance use, and related issues. Veterans assigned to the AHCM condition will have a case manager who is integrated with the interdisciplinary treatment team. The AHCM will meet with the Veteran weekly, assist the Veteran with potential housing options, support the Veteran in continuing addiction treatment and psychiatric care, visit the Veteran in the community when appropriate, and obtain point of care urine toxicology testing to assess abstinence with the goal of addressing substance use issues proactively. The AHCM will educate the Veteran on needed basic life skills using existing manuals
264486|NCT01346514|O2|Outcome|Arm 2: Housing Support Group(HSG)|The HSG condition involved a weekly drop-in housing support group. The HSG focused on gaining support from fellow study participants and learning from those who successfully obtained housing. Group facilitators provided education about housing resources and assistance with housing-related issues.
264487|NCT01346514|O1|Outcome|Arm 1: Addiction/Housing Case Management(AHCM)|The AHCM condition provided individual case management, delivered at the VA and in the community, designed to assist homeless Veterans with SUD issues. Case management focused on : 1) support in obtaining/maintaining housing through education about resources, coordination with VA and community housing program providers, assistance in establishing housing program eligibility, and problem-solving around threats to housing stability; 2) support for SUD and related issues that affect housing status through treatment engagement/re-engagement, referrals for needed services (e.g. psychiatric, medical, vocational), and addressing substance use issues proactively; 3) promotion of residential stability through Life Skills Training, which was designed to improve key skills (room and self-care, money management, and community participation).
264488|NCT01346514|O2|Outcome|Arm 2: Housing Support Group(HSG)|The HSG condition involved a weekly drop-in housing support group. The HSG focused on gaining support from fellow study participants and learning from those who successfully obtained housing. Group facilitators provided education about housing resources and assistance with housing-related issues.
264489|NCT01346514|O1|Outcome|Arm 1: Addiction/Housing Case Management(AHCM)|The AHCM condition provided individual case management, delivered at the VA and in the community, designed to assist homeless Veterans with SUD issues. Case management focused on : 1) support in obtaining/maintaining housing through education about resources, coordination with VA and community housing program providers, assistance in establishing housing program eligibility, and problem-solving around threats to housing stability; 2) support for SUD and related issues that affect housing status through treatment engagement/re-engagement, referrals for needed services (e.g. psychiatric, medical, vocational), and addressing substance use issues proactively; 3) promotion of residential stability through Life Skills Training, which was designed to improve key skills (room and self-care, money management, and community participation).
264490|NCT01346514|O2|Outcome|Arm 2/Housing Support Group (HSG)|The HSG condition involved a weekly drop-in housing support group. The HSG focused on gaining support from fellow study participants and learning from those who successfully obtained housing. Group facilitators provided education about housing resources and assistance with housing-related issues.
264491|NCT01346514|O1|Outcome|Arm 1/Addiction Housing Case Management (AHCM)|The AHCM condition provided individual case management, delivered at the VA and in the community, designed to assist homeless Veterans with SUD issues. Case management focused on : 1) support in obtaining/maintaining housing through education about resources, coordination with VA and community housing program providers, assistance in establishing housing program eligibility, and problem-solving around threats to housing stability; 2) support for SUD and related issues that affect housing status through treatment engagement/re-engagement, referrals for needed services (e.g. psychiatric, medical, vocational), and addressing substance use issues proactively; 3) promotion of residential stability through Life Skills Training, which was designed to improve key skills (room and self-care, money management, and community participation).
264492|NCT01346514|O2|Outcome|Arm 2: Housing Support Group(HSG)|The HSG condition involved a weekly drop-in housing support group. The HSG focused on gaining support from fellow study participants and learning from those who successfully obtained housing. Group facilitators provided education about housing resources and assistance with housing-related issues.
264493|NCT01346514|O1|Outcome|Arm 1: Addiction/Housing Case Management(AHCM)|The AHCM condition provided individual case management, delivered at the VA and in the community, designed to assist homeless Veterans with SUD issues. Case management focused on : 1) support in obtaining/maintaining housing through education about resources, coordination with VA and community housing program providers, assistance in establishing housing program eligibility, and problem-solving around threats to housing stability; 2) support for SUD and related issues that affect housing status through treatment engagement/re-engagement, referrals for needed services (e.g. psychiatric, medical, vocational), and addressing substance use issues proactively; 3) promotion of residential stability through Life Skills Training, which was designed to improve key skills (room and self-care, money management, and community participation).
282646|NCT01292642|E1|Reported Event|Treatment|CBT plus NRT
264494|NCT01346514|O2|Outcome|Arm 2/Housing Support Group (HSG)|The HSG condition involved a weekly drop-in housing support group. The HSG focused on gaining support from fellow study participants and learning from those who successfully obtained housing. Group facilitators provided education about housing resources and assistance with housing-related issues.
264495|NCT01346514|O1|Outcome|Arm 1/Addiction Housing Case Management (AHCM)|The AHCM condition provided individual case management, delivered at the VA and in the community, designed to assist homeless Veterans with SUD issues. Case management focused on : 1) support in obtaining/maintaining housing through education about resources, coordination with VA and community housing program providers, assistance in establishing housing program eligibility, and problem-solving around threats to housing stability; 2) support for SUD and related issues that affect housing status through treatment engagement/re-engagement, referrals for needed services (e.g. psychiatric, medical, vocational), and addressing substance use issues proactively; 3) promotion of residential stability through Life Skills Training, which was designed to improve key skills (room and self-care, money management, and community participation).
264496|NCT01346514|O2|Outcome|Arm 2: Housing Support Group(HSG)|The HSG condition involved a weekly drop-in housing support group. The HSG focused on gaining support from fellow study participants and learning from those who successfully obtained housing. Group facilitators provided education about housing resources and assistance with housing-related issues.
264497|NCT01346514|O1|Outcome|Arm 1: Addiction/Housing Case Management(AHCM)|The AHCM condition provided individual case management, delivered at the VA and in the community, designed to assist homeless Veterans with SUD issues. Case management focused on : 1) support in obtaining/maintaining housing through education about resources, coordination with VA and community housing program providers, assistance in establishing housing program eligibility, and problem-solving around threats to housing stability; 2) support for SUD and related issues that affect housing status through treatment engagement/re-engagement, referrals for needed services (e.g. psychiatric, medical, vocational), and addressing substance use issues proactively; 3) promotion of residential stability through Life Skills Training, which was designed to improve key skills (room and self-care, money management, and community participation).
264498|NCT01346514|O2|Outcome|Arm 2/Housing Support Group (HSG)|The HSG condition involved a weekly drop-in housing support group. The HSG focused on gaining support from fellow study participants and learning from those who successfully obtained housing. Group facilitators provided education about housing resources and assistance with housing-related issues.
264499|NCT01346514|O1|Outcome|Arm 1/Addiction Housing Case Management (AHCM)|The AHCM condition provided individual case management, delivered at the VA and in the community, designed to assist homeless Veterans with SUD issues. Case management focused on : 1) support in obtaining/maintaining housing through education about resources, coordination with VA and community housing program providers, assistance in establishing housing program eligibility, and problem-solving around threats to housing stability; 2) support for SUD and related issues that affect housing status through treatment engagement/re-engagement, referrals for needed services (e.g. psychiatric, medical, vocational), and addressing substance use issues proactively; 3) promotion of residential stability through Life Skills Training, which was designed to improve key skills (room and self-care, money management, and community participation).
264500|NCT01346514|E2|Reported Event|Arm 2/Housing Support Group (HSG)|HSG/ The Housing Support Group is a time and attention control. Veterans assigned to HSG attend a weekly drop-in housing group where housing options are discussed and participants receive support from one another.
264501|NCT01346514|E1|Reported Event|Arm 1/Addiction Housing Case Management (AHCM)|AHCM intervention/ AHCM involves intensive case management for housing, substance use, and related issues. Veterans assigned to the AHCM condition will have a case manager who is integrated with the interdisciplinary treatment team. The AHCM will meet with the Veteran weekly, assist the Veteran with potential housing options, support the Veteran in continuing addiction treatment and psychiatric care, visit the Veteran in the community when appropriate, and obtain point of care urine toxicology testing to assess abstinence with the goal of addressing substance use issues proactively. The AHCM will educate the Veteran on needed basic life skills using existing manuals
264502|NCT01346501|B3|Baseline|Total|Total of all reporting groups
264503|NCT01346501|B2|Baseline|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
264504|NCT01346501|B1|Baseline|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
264505|NCT01346501|P2|Participant Flow|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
264506|NCT01346501|P1|Participant Flow|Adalimumab|Participants with Rheumatoid Arthritis (RA) who continued adalimumab treatment after completion of study M06-859 (HOPEFUL I study; NCT00870467), participated in the observational period of studies P12-069 (HOPEFUL II study; NCT01163292) and P12-707 (HOPEFUL III study; NCT01346501).
264507|NCT01346501|O2|Outcome|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859 and re-started adalimumab treatment during the observational period of studies P12-069 and P12-707.
264508|NCT01346501|O1|Outcome|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
264509|NCT01346501|O2|Outcome|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
264510|NCT01346501|O1|Outcome|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
264511|NCT01346501|O2|Outcome|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
264512|NCT01346501|O1|Outcome|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
264513|NCT01346501|O2|Outcome|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
283110|NCT01290952|B3|Baseline|Total|Total of all reporting groups
264515|NCT01346501|O1|Outcome|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859 and sustained low disease activity (defined as DAS28-CRP score <3.2 at Week 46 and Week 52), participated in the observational period of studies P12-069 and P12-707.
264516|NCT01346501|E2|Reported Event|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859 and re-started adalimumab treatment during the observational period of studies P12-069 and P12-707
264517|NCT01346501|E1|Reported Event|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707
264518|NCT01346488|B1|Baseline|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
264519|NCT01346488|P1|Participant Flow|Participants Receiving Adalimumab|Participants with rheumatoid arthritis (RA) treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
264520|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
264521|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
264522|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
264523|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
264524|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
264525|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
264526|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
264527|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
264528|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
264529|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
264530|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
264531|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
264532|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
264533|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
264534|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
264535|NCT01346488|E1|Reported Event|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
264536|NCT01346475|B3|Baseline|Total|Total of all reporting groups
264537|NCT01346475|B2|Baseline|High Dose Valacyclovir|
264538|NCT01346475|B1|Baseline|Valacyclovir|
264540|NCT01346475|P1|Participant Flow|Standard-dose Valacyclovir First Then High-dose Valacyclovir|Standard-dose valacyclovir (500 mg daily) for 5 weeks followed by 1 week wash-out and then high-dose valacyclovir (1 gram three times daily) for 5 weeks
264541|NCT01346475|O2|Outcome|High-dose Valacyclovir (1 gm Three Times Daily)|
264542|NCT01346475|O1|Outcome|Standard-dose Valacyclovir (500 mg Daily)|
264543|NCT01346475|O2|Outcome|High-dose Valacyclovir (1 gm Three Times Daily)|
264544|NCT01346475|O1|Outcome|Standard-dose Valacyclovir (500 mg Daily)|
264545|NCT01346475|O2|Outcome|High-dose Valacyclovir (1 gm Three Times Daily)|
264546|NCT01346475|O1|Outcome|Standard-dose Valacyclovir (500 mg Daily)|
264547|NCT01346475|O2|Outcome|High-dose Valacyclovir (1 gm Three Times Daily)|
264548|NCT01346475|O1|Outcome|Standard-dose Valacyclovir (500 mg Daily)|
264549|NCT01346475|E2|Reported Event|High Dose Valacyclovir|
264550|NCT01346475|E1|Reported Event|Valacyclovir|
264551|NCT01346410|B1|Baseline|Stereotactic Radiation to Pancreas|"Stereotactic Radiation to Pancreas~Stereotactic Body Radiotherapy: Suggested fractionation is 20-25 Gy / 1 fraction OR 30-36 Gy / 3 fractions (10-12 Gy per fraction) OR 40-45 Gy / 5 fractions (8-9 Gy per fraction)"
264552|NCT01346410|P1|Participant Flow|Stereotactic Radiation to Pancreas|"Stereotactic Radiation to Pancreas~Stereotactic Body Radiotherapy: Suggested fractionation is 20-25 Gy / 1 fraction OR 30-36 Gy / 3 fractions (10-12 Gy per fraction) OR 40-45 Gy / 5 fractions (8-9 Gy per fraction)"
264553|NCT01346410|O1|Outcome|Stereotactic Radiation to Pancreas|"Stereotactic Radiation to Pancreas~Stereotactic Body Radiotherapy: Suggested fractionation is 20-25 Gy / 1 fraction OR 30-36 Gy / 3 fractions (10-12 Gy per fraction) OR 40-45 Gy / 5 fractions (8-9 Gy per fraction)"
264554|NCT01346410|E1|Reported Event|Stereotactic Radiation to Pancreas|"Stereotactic Radiation to Pancreas~Stereotactic Body Radiotherapy: Suggested fractionation is 20-25 Gy / 1 fraction OR 30-36 Gy / 3 fractions (10-12 Gy per fraction) OR 40-45 Gy / 5 fractions (8-9 Gy per fraction)"
264555|NCT01346397|B3|Baseline|Total|Total of all reporting groups
264556|NCT01346397|B2|Baseline|Tacrolimus Group|"tacrolimus group - after alemtuzumab induction tacrolimus was administered~cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered"
264557|NCT01346397|B1|Baseline|Cyclosporine Group|cyclosporine group - after alemtuzumab induction cyclosporine was administered
264558|NCT01346397|P2|Participant Flow|Tacrolimus Group|tacrolimus group - after Campath induction tacrolimus will be administered
264559|NCT01346397|P1|Participant Flow|Cyclosporine Group|cyclosporine group - after Campath induction cyclosporine will be administered
264560|NCT01346397|O2|Outcome|Tacrolimus Group|"tacrolimus group - after alemtuzumab induction tacrolimus was administered~cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered"
264561|NCT01346397|O1|Outcome|Cyclosporine Group|cyclosporine group - after alemtuzumab induction cyclosporine was administered
264562|NCT01346397|O2|Outcome|Tacrolimus Group|"tacrolimus group - after alemtuzumab induction tacrolimus was administered~cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered"
264563|NCT01346397|O1|Outcome|Cyclosporine Group|cyclosporine group - after alemtuzumab induction cyclosporine was administered
264564|NCT01346397|E2|Reported Event|Tacrolimus Group|"tacrolimus group - after alemtuzumab induction tacrolimus was administered~cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered"
264565|NCT01346397|E1|Reported Event|Cyclosporine Group|cyclosporine group - after alemtuzumab induction cyclosporine was administered
264566|NCT01346293|B3|Baseline|Total|Total of all reporting groups
264567|NCT01346293|B2|Baseline|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
264568|NCT01346293|B1|Baseline|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
264569|NCT01346293|P2|Participant Flow|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
264570|NCT01346293|P1|Participant Flow|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
264571|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
264572|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
264573|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
264574|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
264575|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
264576|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
264577|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
264578|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
264579|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
284511|NCT01288079|O2|Outcome|4 mg BID TC-5214|
264580|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
264581|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
264582|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
264583|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
264584|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
264585|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
264586|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
264587|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
264588|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
264589|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
264590|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
264591|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
264592|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
264593|NCT01346293|E2|Reported Event|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
264594|NCT01346293|E1|Reported Event|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
264595|NCT01346189|B5|Baseline|Total|Total of all reporting groups
264596|NCT01346189|B4|Baseline|Usual Care|No Intervention
264597|NCT01346189|B3|Baseline|Physician and Patient Combined Incentives|"(with adherence feedback)~Quarterly payments shared evenly by physician and patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL. Physicians will receive daily information about patients' statin adherence.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
264598|NCT01346189|B2|Baseline|Patient Incentives|"(with adherence feedback)~Quarterly payments to patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
264599|NCT01346189|B1|Baseline|Physician Incentives|"(with adherence feedback)~Quarterly payments to physician combined based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL with daily patient statin adherence information made available.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
264600|NCT01346189|P4|Participant Flow|Usual Care/Control|No Intervention
264601|NCT01346189|P3|Participant Flow|Physician and Patient Combined Incentives|"(with adherence feedback)~Quarterly payments shared evenly by physician and patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL. Physicians will receive daily information about patients' statin adherence.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
264602|NCT01346189|P2|Participant Flow|Patient Incentives|"(with adherence feedback)~Quarterly payments to patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
264603|NCT01346189|P1|Participant Flow|Physician Incentives|"(with adherence feedback)~Quarterly payments to physician combined based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL with daily patient statin adherence information made available.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
264604|NCT01346189|O4|Outcome|Usual Care|
264605|NCT01346189|O3|Outcome|Physician and Patient Combined Incentives|"(with adherence feedback)~Quarterly payments shared evenly by physician and patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL. Physicians will receive daily information about patients' statin adherence.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
264606|NCT01346189|O2|Outcome|Patient Incentives|"(with adherence feedback)~Quarterly payments to patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
264607|NCT01346189|O1|Outcome|Physician Incentives|"(with adherence feedback)~Quarterly payments to physician combined based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL with daily patient statin adherence information made available.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
264609|NCT01346189|O3|Outcome|Physician and Patient Combined Incentives|"(with adherence feedback)~Quarterly payments shared evenly by physician and patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL. Physicians will receive daily information about patients' statin adherence.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
264610|NCT01346189|O2|Outcome|Patient Incentives|"(with adherence feedback)~Quarterly payments to patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
264611|NCT01346189|O1|Outcome|Physician Incentives|"(with adherence feedback)~Quarterly payments to physician combined based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL with daily patient statin adherence information made available.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
264612|NCT01346189|E4|Reported Event|Usual Care/Control|
264613|NCT01346189|E3|Reported Event|Physician and Patient Combined Incentives|"(with adherence feedback)~Quarterly payments shared evenly by physician and patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL. Physicians will receive daily information about patients' statin adherence.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
264614|NCT01346189|E2|Reported Event|Patient Incentives|"(with adherence feedback)~Quarterly payments to patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
264615|NCT01346189|E1|Reported Event|Physician Incentives|"(with adherence feedback)~Quarterly payments to physician combined based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL with daily patient statin adherence information made available.~Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers."
264616|NCT01346176|B4|Baseline|Total|Total of all reporting groups
264617|NCT01346176|B3|Baseline|Forced Choice|Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.
264618|NCT01346176|B2|Baseline|Negative Default|Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections
264619|NCT01346176|B1|Baseline|Positive Default|Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections
264620|NCT01346176|P3|Participant Flow|Forced Choice|Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.
264621|NCT01346176|P2|Participant Flow|Negative Default|Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections
264622|NCT01346176|P1|Participant Flow|Positive Default|Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections
264623|NCT01346176|O3|Outcome|Forced Choice|Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.
264624|NCT01346176|O2|Outcome|Negative Default|Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections
264625|NCT01346176|O1|Outcome|Positive Default|Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections
264626|NCT01346176|O3|Outcome|Forced Choice|Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.
264627|NCT01346176|O2|Outcome|Negative Default|Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections
264628|NCT01346176|O1|Outcome|Positive Default|Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections
264629|NCT01346176|E3|Reported Event|Positive Default|
264630|NCT01346176|E2|Reported Event|Negative Default|
264631|NCT01346176|E1|Reported Event|Forced Choice|
264632|NCT01346085|B1|Baseline|CNI-free Single-group|CNI free immunosuppression: Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).
264633|NCT01346085|P1|Participant Flow|CNI-free Single-group|CNI free immunosuppression: Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).
264634|NCT01346085|O1|Outcome|CNI-free Single-group|CNI free immunosuppression: Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).
264667|NCT01345929|O1|Outcome|CXA-201 as Treatment for cUTI|"CXA-201 IV infusion (1500mg q8) for 7 days~CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days"
264668|NCT01345929|O2|Outcome|Levofloxacin as Treatment for cUTI|"Levofloxacin IV infusion (750mg qd) for 7 days~Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days"
264635|NCT01346085|O1|Outcome|CNI-free Single-group|CNI free immunosuppression: Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).
264636|NCT01346085|E1|Reported Event|CNI-free Single-group|CNI free immunosuppression: Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).
264637|NCT01346072|B3|Baseline|Total|Total of all reporting groups
264638|NCT01346072|B2|Baseline|Tolvaptan Low Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~Low Copeptin < 10 pmol/L at baseline"
264639|NCT01346072|B1|Baseline|Tolvaptan High Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~High Copeptin ≥ 10 pmol/L at baseline"
264640|NCT01346072|P2|Participant Flow|Tolvaptan Low Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~Low Copeptin < 10 pmol/L at baseline"
264641|NCT01346072|P1|Participant Flow|Tolvaptan High Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~High Copeptin ≥ 10 pmol/L at baseline"
264642|NCT01346072|O2|Outcome|Tolvaptan Low Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~Low Copeptin < 10 pmol/L at baseline"
264643|NCT01346072|O1|Outcome|Tolvaptan High Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~High Copeptin ≥ 10 pmol/L at baseline"
264644|NCT01346072|O2|Outcome|Tolvaptan Low Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~Low Copeptin < 10 pmol/L at baseline"
264645|NCT01346072|O1|Outcome|Tolvaptan High Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~High Copeptin ≥ 10 pmol/L at baseline"
264646|NCT01346072|E2|Reported Event|Tolvaptan Low Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~Low Copeptin < 10 pmol/L at baseline"
264647|NCT01346072|E1|Reported Event|Tolvaptan High Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~High Copeptin ≥ 10 pmol/L at baseline"
264648|NCT01346059|B3|Baseline|Total|Total of all reporting groups
264649|NCT01346059|B2|Baseline|Vancomycin|"The vancomycin arm will receive vancomycin solution through the catheter.~Vancomycin: Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline."
264650|NCT01346059|B1|Baseline|Saline|"The saline arm will receive normal saline through the catheter as a placebo.~Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used."
264651|NCT01346059|P2|Participant Flow|Vancomycin|"The vancomycin arm will receive vancomycin solution through the catheter.~Vancomycin: Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline."
264652|NCT01346059|P1|Participant Flow|Saline|"The saline arm will receive normal saline through the catheter as a placebo.~Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used."
264653|NCT01346059|O2|Outcome|Vancomycin|"The vancomycin arm will receive vancomycin solution through the catheter.~Vancomycin: Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline."
264654|NCT01346059|O1|Outcome|Saline|"The saline arm will receive normal saline through the catheter as a placebo.~Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used."
264655|NCT01346059|O2|Outcome|Vancomycin|"The vancomycin arm will receive vancomycin solution through the catheter.~Vancomycin: Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline."
264656|NCT01346059|O1|Outcome|Saline|"The saline arm will receive normal saline through the catheter as a placebo.~Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used."
264657|NCT01346059|O2|Outcome|Vancomycin|"The vancomycin arm will receive vancomycin solution through the catheter.~Vancomycin: Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline."
264658|NCT01346059|O1|Outcome|Saline|"The saline arm will receive normal saline through the catheter as a placebo.~Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used."
264659|NCT01346059|E2|Reported Event|Vancomycin|"The vancomycin arm will receive vancomycin solution through the catheter.~Vancomycin: Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline."
264660|NCT01346059|E1|Reported Event|Saline|"The saline arm will receive normal saline through the catheter as a placebo.~Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used."
264661|NCT01345929|B3|Baseline|Total|Total of all reporting groups
264662|NCT01345929|B2|Baseline|Levofloxacin as Treatment for cUTI|"Levofloxacin IV infusion (750mg qd) for 7 days~Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days"
264663|NCT01345929|B1|Baseline|CXA-201 as Treatment for cUTI|"CXA-201 IV infusion (1500mg q8) for 7 days~CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days"
264664|NCT01345929|P2|Participant Flow|Levofloxacin as Treatment for cUTI|"Levofloxacin IV infusion (750mg qd) for 7 days~Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days~Of the 1083 subjects in the integrated analysis set, 535 received levofloxacin."
264665|NCT01345929|P1|Participant Flow|CXA-201 as Treatment for cUTI|"CXA-201 IV infusion (1500mg q8) for 7 days~CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days~Of the 1083 subjects in the integrated analysis set, 533 received CXA."
264669|NCT01345929|O1|Outcome|CXA-201 as Treatment for cUTI|"CXA-201 IV infusion (1500mg q8) for 7 days~CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days"
264670|NCT01345929|E2|Reported Event|Levofloxacin as Treatment for cUTI|"Levofloxacin IV infusion (750mg qd) for 7 days~Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days"
264671|NCT01345929|E1|Reported Event|CXA-201 as Treatment for cUTI|"CXA-201 IV infusion (1500mg q8) for 7 days~CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days"
264672|NCT01345786|B5|Baseline|Total|Total of all reporting groups
264673|NCT01345786|B4|Baseline|Part 2 - Sequence 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 2 and Period 4. Participants in Part 2 were from Site 2."
264674|NCT01345786|B3|Baseline|Part 2 - Sequence 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B) on the first day of Period 2 and Period 4. Participants in Part 2 were from Site 2."
264675|NCT01345786|B2|Baseline|Part 1 - Sequence 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 2 and Period 4. Participants in Part 1 were from Site 1."
264676|NCT01345786|B1|Baseline|Part 1 - Sequence 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A) on the first day of Period 2 and Period 4. Participants in Part 1 were from Site 1."
264677|NCT01345786|P4|Participant Flow|Part 2 - Sequence 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 2 and Period 4. Participants in Part 2 were from Site 2."
264678|NCT01345786|P3|Participant Flow|Part 2 - Sequence 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B) on the first day of Period 2 and Period 4. Participants in Part 2 were from Site 2."
264679|NCT01345786|P2|Participant Flow|Part 1 - Sequence 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 2 and Period 4. Participants in Part 1 were from Site 1."
264680|NCT01345786|P1|Participant Flow|Part 1 - Sequence 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A) on the first day of Period 2 and Period 4. Participants in Part 1 were from Site 1."
264681|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
264682|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
264683|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
264684|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
264685|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
264686|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
264687|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
264873|NCT01345591|O3|Outcome|Fat Grafting_3 Months Post op|quality of life measurement at 3 months post-op to include SWAP, COPE and CSQ-8 questionnaires
264688|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
264689|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
264690|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
264691|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
264692|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
264693|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
264694|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
264695|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
264696|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
264697|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
264698|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
264699|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
264700|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
264701|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
264702|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
264703|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
264704|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
264747|NCT01345721|O1|Outcome|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
264705|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
264706|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
264707|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
264708|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
264709|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
264710|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
264711|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
264712|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
264713|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
264714|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
264715|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
264716|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
264717|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
264718|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
264719|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
264720|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
264721|NCT01345786|E4|Reported Event|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
264748|NCT01345721|O3|Outcome|MenC (1 Primary Dose) + MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
264722|NCT01345786|E3|Reported Event|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
264723|NCT01345786|E2|Reported Event|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
264724|NCT01345786|E1|Reported Event|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
264725|NCT01345721|B4|Baseline|Total|Total of all reporting groups
264726|NCT01345721|B3|Baseline|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
264727|NCT01345721|B2|Baseline|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
264728|NCT01345721|B1|Baseline|MenACWY (2 Primary +1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
264729|NCT01345721|P3|Participant Flow|MenC (1 Primary Dose) + MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
264730|NCT01345721|P2|Participant Flow|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
264731|NCT01345721|P1|Participant Flow|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
264732|NCT01345721|O3|Outcome|MenC (1 Primary Dose) + MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
264733|NCT01345721|O2|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
264734|NCT01345721|O1|Outcome|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
264735|NCT01345721|O3|Outcome|MenC (1 Primary Dose) + MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
264736|NCT01345721|O2|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
264737|NCT01345721|O1|Outcome|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
264738|NCT01345721|O2|Outcome|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study
264739|NCT01345721|O1|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study
264740|NCT01345721|O2|Outcome|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study
264741|NCT01345721|O1|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study
264742|NCT01345721|O1|Outcome|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
264743|NCT01345721|O1|Outcome|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
264744|NCT01345721|O2|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
264745|NCT01345721|O1|Outcome|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
264746|NCT01345721|O2|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
264874|NCT01345591|O2|Outcome|Fat Grafting_7-21 Days Post op|quality of life measurement at 7-21 days post-op to include SWAP, COPE and CSQ-8 questionnaires
264749|NCT01345721|O2|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
264750|NCT01345721|O1|Outcome|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
264751|NCT01345721|O3|Outcome|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
264752|NCT01345721|O2|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
264753|NCT01345721|O1|Outcome|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
264754|NCT01345721|E3|Reported Event|MenC (1 Primary Dose) + MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
264755|NCT01345721|E2|Reported Event|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
264756|NCT01345721|E1|Reported Event|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
264757|NCT01345682|B3|Baseline|Total|Total of all reporting groups
264758|NCT01345682|B2|Baseline|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264759|NCT01345682|B1|Baseline|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 milligram (mg) once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264760|NCT01345682|P2|Participant Flow|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264761|NCT01345682|P1|Participant Flow|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 milligram (mg) once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264762|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264763|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 milligram (mg) once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264764|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264765|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 milligram (mg) once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264766|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264767|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 milligram (mg) once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264768|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264769|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 milligram (mg) once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264770|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264875|NCT01345591|O1|Outcome|Fat Grafting_evaluation at Baseline|quality of life measurement at baseline to include SWAP, COPE and CSQ-8 questionnaires
264771|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 milligram (mg) once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264772|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264773|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 milligram (mg) once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264774|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264775|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 milligram (mg) once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264776|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264777|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 milligram (mg) once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264778|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264779|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 milligram (mg) once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264780|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264781|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 milligram (mg) once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264782|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264783|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 milligram (mg) once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264784|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264785|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 milligram (mg) once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264786|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264787|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 milligram (mg) once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264788|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264789|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 milligram (mg) once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264840|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264790|NCT01345682|E2|Reported Event|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 milligram per square meter mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264791|NCT01345682|E1|Reported Event|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 milligram (mg) once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
264792|NCT01345669|B3|Baseline|Total|Total of all reporting groups
264793|NCT01345669|B2|Baseline|Placebo|Patient received placebo matching Afatinib film-coated tablets with matching Afatinib dosage regimen, orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
264794|NCT01345669|B1|Baseline|Afatinib (BIBW 2992)|Patient received Afatinib film-coated tablets with starting dose 40 mg (milligram)/day and escalation to 50 mg/day and/or reduction to 40, 30 or 20 mg/day according to absence or presence of drug-related adverse events (AEs), orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
264795|NCT01345669|P2|Participant Flow|Placebo|Patient received placebo matching Afatinib film-coated tablets with matching Afatinib dosage regimen, orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
264796|NCT01345669|P1|Participant Flow|Afatinib (BIBW 2992)|Patient received Afatinib film-coated tablets with starting dose 40 mg (milligram)/day and escalation to 50 mg/day and/or reduction to 40, 30 or 20 mg/day according to absence or presence of drug-related adverse events (AEs), orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
264797|NCT01345669|O2|Outcome|Placebo|Patient received placebo matching Afatinib film-coated tablets with matching Afatinib dosage regimen, orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
264798|NCT01345669|O1|Outcome|Afatinib (BIBW 2992)|Patient received Afatinib film-coated tablets with starting dose 40 mg (milligram)/day and escalation to 50 mg/day and/or reduction to 40, 30 or 20 mg/day according to absence or presence of drug-related adverse events (AEs), orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
264799|NCT01345669|O2|Outcome|Placebo|Patient received placebo matching Afatinib film-coated tablets with matching Afatinib dosage regimen, orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
264800|NCT01345669|O1|Outcome|Afatinib (BIBW 2992)|Patient received Afatinib film-coated tablets with starting dose 40 mg (milligram)/day and escalation to 50 mg/day and/or reduction to 40, 30 or 20 mg/day according to absence or presence of drug-related adverse events (AEs), orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
264801|NCT01345669|O2|Outcome|Placebo|Patient received placebo matching Afatinib film-coated tablets with matching Afatinib dosage regimen, orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
264802|NCT01345669|O1|Outcome|Afatinib (BIBW 2992)|Patient received Afatinib film-coated tablets with starting dose 40 mg (milligram)/day and escalation to 50 mg/day and/or reduction to 40, 30 or 20 mg/day according to absence or presence of drug-related adverse events (AEs), orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
264803|NCT01345669|O2|Outcome|Placebo|Patient received placebo matching Afatinib film-coated tablets with matching Afatinib dosage regimen, orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
264804|NCT01345669|O1|Outcome|Afatinib (BIBW 2992)|Patient received Afatinib film-coated tablets with starting dose 40 mg (milligram)/day and escalation to 50 mg/day and/or reduction to 40, 30 or 20 mg/day according to absence or presence of drug-related adverse events (AEs), orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
264805|NCT01345669|O2|Outcome|Placebo|Patient received placebo matching Afatinib film-coated tablets with matching Afatinib dosage regimen, orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
264806|NCT01345669|O1|Outcome|Afatinib (BIBW 2992)|Patient received Afatinib film-coated tablets with starting dose 40 mg (milligram)/day and escalation to 50 mg/day and/or reduction to 40, 30 or 20 mg/day according to absence or presence of drug-related adverse events (AEs), orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
264807|NCT01345669|O2|Outcome|Placebo|Patient received placebo matching Afatinib film-coated tablets with matching Afatinib dosage regimen, orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
264808|NCT01345669|O1|Outcome|Afatinib (BIBW 2992)|Patient received Afatinib film-coated tablets with starting dose 40 mg (milligram)/day and escalation to 50 mg/day and/or reduction to 40, 30 or 20 mg/day according to absence or presence of drug-related adverse events (AEs), orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
264809|NCT01345669|E2|Reported Event|Placebo|Patient received placebo matching Afatinib film-coated tablets with matching Afatinib dosage regimen, orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
264841|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264810|NCT01345669|E1|Reported Event|Afatinib (BIBW 2992)|Patient received Afatinib film-coated tablets with starting dose 40 mg (milligram)/day and escalation to 50 mg/day and/or reduction to 40, 30 or 20 mg/day according to absence or presence of drug-related adverse events (AEs), orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
264811|NCT01345630|B3|Baseline|Total|Total of all reporting groups
264812|NCT01345630|B2|Baseline|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264813|NCT01345630|B1|Baseline|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264814|NCT01345630|P2|Participant Flow|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264815|NCT01345630|P1|Participant Flow|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264816|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264817|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264818|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264819|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264820|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264821|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264822|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264823|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264824|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264825|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264826|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264827|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264828|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264829|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264830|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264831|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264832|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264833|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264834|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264835|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264836|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264837|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264838|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264839|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264876|NCT01345591|O2|Outcome|Fat Graft Volume at 9 Months|fat grafting for facial trauma, volume measured at 9 months post-op
264842|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264843|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264844|NCT01345630|O4|Outcome|FTC/TDF+DRV/r - Failure|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily. Summary of tropism results corresponding to timepoint at or after PDTF.
264845|NCT01345630|O3|Outcome|FTC/TDF+DRV/r - Baseline|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily. Summary of tropism results by baseline.
264846|NCT01345630|O2|Outcome|MVC+DRV/r - Failure|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily. Summary of tropism results corresponding to timepoint at or after PDTF.
264847|NCT01345630|O1|Outcome|MVC+DRV/r - Baseline|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily. Summary of tropism results by baseline.
264848|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264849|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264850|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264851|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264852|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264853|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264854|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264855|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264856|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264857|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264858|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264859|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264860|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264861|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264862|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264863|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264864|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264865|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264866|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264867|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264868|NCT01345630|E2|Reported Event|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
264869|NCT01345630|E1|Reported Event|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
264870|NCT01345591|B1|Baseline|Fat Grafting|Fat Grafting for facial trauma
264871|NCT01345591|P1|Participant Flow|Fat Grafting|fat grafting for facial trauma
264872|NCT01345591|O4|Outcome|Fat Grafting_9 Months Post-op|quality of life measurement at 9 months post-op to include SWAP, COPE and CSQ-8 questionnaires
284512|NCT01288079|O1|Outcome|1 mg BID TC-5214|
264879|NCT01345318|B1|Baseline|PF-04236921|All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
264880|NCT01345318|P1|Participant Flow|PF-04236921|All participants entering this study were given a 50 mg subcutaneous (SC) dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
264881|NCT01345318|O1|Outcome|PF-04236921|All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
264882|NCT01345318|O1|Outcome|PF-04236921|All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
264883|NCT01345318|E1|Reported Event|PF-04236921|All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
264884|NCT01345292|B4|Baseline|Total|Total of all reporting groups
264885|NCT01345292|B3|Baseline|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
264886|NCT01345292|B2|Baseline|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
264887|NCT01345292|B1|Baseline|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
264888|NCT01345292|P3|Participant Flow|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
264889|NCT01345292|P2|Participant Flow|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
264890|NCT01345292|P1|Participant Flow|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
264891|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
264892|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
264893|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
264894|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
264895|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
264896|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
264897|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
264898|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
264899|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
264900|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
264901|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
264902|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
264903|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
264904|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
264905|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
264906|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
264907|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
264908|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
264909|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
264910|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
264911|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
264912|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
264913|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
264914|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
264915|NCT01345292|E3|Reported Event|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
264916|NCT01345292|E2|Reported Event|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
264917|NCT01345292|E1|Reported Event|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
264918|NCT01345253|B3|Baseline|Total|Total of all reporting groups
264919|NCT01345253|B2|Baseline|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
264920|NCT01345253|B1|Baseline|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
264921|NCT01345253|P2|Participant Flow|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
264922|NCT01345253|P1|Participant Flow|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
264923|NCT01345253|O2|Outcome|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
264924|NCT01345253|O1|Outcome|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
264925|NCT01345253|O2|Outcome|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
264926|NCT01345253|O1|Outcome|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
264927|NCT01345253|O2|Outcome|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
264928|NCT01345253|O1|Outcome|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
264929|NCT01345253|O2|Outcome|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
264930|NCT01345253|O1|Outcome|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
264931|NCT01345253|O2|Outcome|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
264932|NCT01345253|O1|Outcome|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
264933|NCT01345253|E2|Reported Event|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
264934|NCT01345253|E1|Reported Event|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
264935|NCT01345240|B6|Baseline|Total|Total of all reporting groups
264936|NCT01345240|B5|Baseline|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264937|NCT01345240|B4|Baseline|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264938|NCT01345240|B3|Baseline|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265052|NCT01345123|P1|Participant Flow|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
265053|NCT01345123|O3|Outcome|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
265119|NCT01344876|O3|Outcome|OPB-51602 3mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
264939|NCT01345240|B2|Baseline|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264940|NCT01345240|B1|Baseline|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264941|NCT01345240|P5|Participant Flow|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264942|NCT01345240|P4|Participant Flow|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264943|NCT01345240|P3|Participant Flow|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264944|NCT01345240|P2|Participant Flow|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264945|NCT01345240|P1|Participant Flow|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265054|NCT01345123|O2|Outcome|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
265055|NCT01345123|O1|Outcome|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
264946|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264947|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264948|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264949|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264950|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264951|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264952|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264988|NCT01345240|O2|Outcome|Engerix B Group|Subjects in this group were subjects from the Engerix B Regimen A and Engerix B Regimen B groups were administered Engerix B™ as a 3-dose primary vaccination course, at Weeks 0, 4 and 8, followed by a booster dose, at Month 50. Subjects in this group were also administered, according to varied schedules, depending on the vaccination regimen they were allocated too in their respective group, doses Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™ and of vaccines against yellow fever and against measles. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264953|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264954|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264955|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264956|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264957|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264958|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264959|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265037|NCT01345162|B3|Baseline|Total|Total of all reporting groups
265038|NCT01345162|B2|Baseline|Acetaminophene + Tramadol|"acetaminophene 325mg+tramadol 37,5mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
265039|NCT01345162|B1|Baseline|Ketorolac|"Ketorolac 10mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
265230|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
264960|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264961|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264962|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264963|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264964|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264965|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264966|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265040|NCT01345162|P2|Participant Flow|Acetaminophene + Tramadol|"acetaminophene 325mg+tramadol 37,5mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
265041|NCT01345162|P1|Participant Flow|Ketorolac|"Ketorolac 10mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
265042|NCT01345162|O2|Outcome|Acetaminophene + Tramadol|"acetaminophene 325mg+tramadol 37,5mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
264967|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264968|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264969|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264970|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264971|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264972|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264973|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265043|NCT01345162|O1|Outcome|Ketorolac|"Ketorolac 10mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
265044|NCT01345162|E2|Reported Event|Acetaminophene + Tramadol|"acetaminophene 325mg+tramadol 37,5mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
265045|NCT01345162|E1|Reported Event|Ketorolac|"Ketorolac 10mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
265046|NCT01345123|B4|Baseline|Total|Total of all reporting groups
264974|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264975|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264976|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264977|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264978|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264979|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264980|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265047|NCT01345123|B3|Baseline|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
265048|NCT01345123|B2|Baseline|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
265056|NCT01345123|O3|Outcome|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
265231|NCT01344460|O2|Outcome|Unenhanced MRA|
264981|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264982|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264983|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264984|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264985|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264986|NCT01345240|O2|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264987|NCT01345240|O1|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265049|NCT01345123|B1|Baseline|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
265050|NCT01345123|P3|Participant Flow|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
265118|NCT01344876|O4|Outcome|OPB-51602 4mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
265232|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
264989|NCT01345240|O1|Outcome|RTS,S Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in any of its formulations, Lot 1, 2 or 3, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264990|NCT01345240|O2|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264991|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264992|NCT01345240|O2|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264993|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264994|NCT01345240|O2|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264995|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264996|NCT01345240|O2|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265233|NCT01344460|O2|Outcome|Unenhanced MRA|
264997|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264998|NCT01345240|O2|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
264999|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265000|NCT01345240|O2|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265001|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265002|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265003|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265004|NCT01345240|O3|Outcome|RTS,S Lot 3 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 3 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265005|NCT01345240|O2|Outcome|RTS,S Lot 2 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 2 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265006|NCT01345240|O1|Outcome|RTS,S Lot 1 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 1 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265007|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265008|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265009|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265010|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265011|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265012|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265013|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265014|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265015|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265016|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265017|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265018|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265019|NCT01345240|O3|Outcome|RTS,S Lot 3 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 3 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265020|NCT01345240|O2|Outcome|RTS,S Lot 2 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 2 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265234|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
265021|NCT01345240|O1|Outcome|RTS,S Lot 1 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 1 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265022|NCT01345240|O3|Outcome|RTS,S Lot 3 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 3 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265023|NCT01345240|O2|Outcome|RTS,S Lot 2 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 2 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265024|NCT01345240|O1|Outcome|RTS,S Lot 1 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 1 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265025|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265026|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265027|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265028|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265051|NCT01345123|P2|Participant Flow|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
265029|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265030|NCT01345240|O2|Outcome|Engerix B Group|Subjects in this group were subjects from the Engerix B Regimen A and Engerix B Regimen B groups were administered Engerix B™ as a 3-dose primary vaccination course, at Weeks 0, 4 and 8, followed by a booster dose, at Month 50. Subjects in this group were also administered, according to varied schedules, depending on the vaccination regimen they were allocated too in their respective group, doses Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™ and of vaccines against yellow fever and against measles. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265031|NCT01345240|O1|Outcome|RTS,S Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in any of its formulations, Lot 1, 2 or 3, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265032|NCT01345240|E5|Reported Event|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265033|NCT01345240|E4|Reported Event|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265034|NCT01345240|E3|Reported Event|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265035|NCT01345240|E2|Reported Event|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265036|NCT01345240|E1|Reported Event|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
265057|NCT01345123|O2|Outcome|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
265058|NCT01345123|O1|Outcome|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
265059|NCT01345123|O3|Outcome|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
265060|NCT01345123|O2|Outcome|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
265061|NCT01345123|O1|Outcome|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
265062|NCT01345123|O3|Outcome|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
265063|NCT01345123|O2|Outcome|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
265064|NCT01345123|O1|Outcome|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
265065|NCT01345123|O3|Outcome|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
265066|NCT01345123|O2|Outcome|Decision Aid Only|Study participants receiving a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
265067|NCT01345123|O1|Outcome|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
265068|NCT01345123|E3|Reported Event|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
265069|NCT01345123|E2|Reported Event|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
265070|NCT01345123|E1|Reported Event|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
265071|NCT01345058|B3|Baseline|Total|Total of all reporting groups
265072|NCT01345058|B2|Baseline|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
265073|NCT01345058|B1|Baseline|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
265074|NCT01345058|P2|Participant Flow|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
265075|NCT01345058|P1|Participant Flow|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
265076|NCT01345058|O2|Outcome|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
265077|NCT01345058|O1|Outcome|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
265078|NCT01345058|O2|Outcome|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
265079|NCT01345058|O1|Outcome|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
265080|NCT01345058|O2|Outcome|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
265081|NCT01345058|O1|Outcome|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
265082|NCT01345058|O2|Outcome|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
265083|NCT01345058|O1|Outcome|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
265084|NCT01345058|O2|Outcome|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
265085|NCT01345058|O1|Outcome|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
265086|NCT01345058|E2|Reported Event|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
265087|NCT01345058|E1|Reported Event|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
265088|NCT01345019|B3|Baseline|Total|Total of all reporting groups
265089|NCT01345019|B2|Baseline|Denosumab|Participants randomized to receive denosumab 120 mg subcutaneous injection and placebo to zoledronic acid intravenously once every 4 weeks until the required number of events was reached.
265090|NCT01345019|B1|Baseline|Zoledronic Acid|Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneous injection once every 4 weeks until the required number of events was reached.
265091|NCT01345019|P2|Participant Flow|Denosumab|Participants randomized to receive denosumab 120 mg subcutaneous injection and placebo to zoledronic acid intravenously once every 4 weeks until the required number of events was reached.
265092|NCT01345019|P1|Participant Flow|Zoledronic Acid|Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneous injection once every 4 weeks until the required number of events was reached.
265093|NCT01345019|O2|Outcome|Denosumab|Participants randomized to receive denosumab 120 mg subcutaneous injection and placebo to zoledronic acid intravenously once every 4 weeks until the required number of events was reached.
265094|NCT01345019|O1|Outcome|Zoledronic Acid|Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneous injection once every 4 weeks until the required number of events was reached.
265095|NCT01345019|O2|Outcome|Denosumab|Participants randomized to receive denosumab 120 mg subcutaneous injection and placebo to zoledronic acid intravenously once every 4 weeks until the required number of events was reached.
265096|NCT01345019|O1|Outcome|Zoledronic Acid|Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneous injection once every 4 weeks until the required number of events was reached.
265097|NCT01345019|O2|Outcome|Denosumab|Participants randomized to receive denosumab 120 mg subcutaneous injection and placebo to zoledronic acid intravenously once every 4 weeks until the required number of events was reached.
265098|NCT01345019|O1|Outcome|Zoledronic Acid|Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneous injection once every 4 weeks until the required number of events was reached.
265099|NCT01345019|O2|Outcome|Denosumab|Participants randomized to receive denosumab 120 mg subcutaneous injection and placebo to zoledronic acid intravenously once every 4 weeks until the required number of events was reached.
265100|NCT01345019|O1|Outcome|Zoledronic Acid|Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneous injection once every 4 weeks until the required number of events was reached.
265101|NCT01345019|O2|Outcome|Denosumab|Participants randomized to receive denosumab 120 mg subcutaneous injection and placebo to zoledronic acid intravenously once every 4 weeks until the required number of events was reached.
265102|NCT01345019|O1|Outcome|Zoledronic Acid|Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneous injection once every 4 weeks until the required number of events was reached.
265103|NCT01345019|O2|Outcome|Denosumab|Participants randomized to receive denosumab 120 mg subcutaneous injection and placebo to zoledronic acid intravenously once every 4 weeks until the required number of events was reached.
265104|NCT01345019|O1|Outcome|Zoledronic Acid|Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneous injection once every 4 weeks until the required number of events was reached.
265105|NCT01345019|O2|Outcome|Denosumab|Participants randomized to receive denosumab 120 mg subcutaneous injection and placebo to zoledronic acid intravenously once every 4 weeks until the required number of events was reached.
265106|NCT01345019|O1|Outcome|Zoledronic Acid|Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneous injection once every 4 weeks until the required number of events was reached.
265107|NCT01345019|O2|Outcome|Denosumab|Participants randomized to receive denosumab 120 mg subcutaneous injection and placebo to zoledronic acid intravenously once every 4 weeks until the required number of events was reached.
265108|NCT01345019|O1|Outcome|Zoledronic Acid|Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneous injection once every 4 weeks until the required number of events was reached.
265109|NCT01345019|E2|Reported Event|Denosumab|Participants received denosumab 120 mg subcutaneous injection and placebo to zoledronic acid intravenously once every 4 weeks until the required number of events was reached.
265110|NCT01345019|E1|Reported Event|Zoledronic Acid|Participants received zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneous injection once every 4 weeks until the required number of events was reached.
265111|NCT01344876|B1|Baseline|OPB-51602|"OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle~OPB-51602: once daily during the treatment period"
265112|NCT01344876|P5|Participant Flow|OPB-51602: 6mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
265113|NCT01344876|P4|Participant Flow|OPB-51602: 4mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
265114|NCT01344876|P3|Participant Flow|OPB-51602: 3mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
265115|NCT01344876|P2|Participant Flow|OPB-51602: 2mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
265116|NCT01344876|P1|Participant Flow|OPB-51602: 1mg/Day|OPB-51602: 1, 2, 3,4 and 6 mg/day oral once daily (QD) in a 4 week cycle
265117|NCT01344876|O5|Outcome|OPB-51602 6mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
265235|NCT01344460|O2|Outcome|Unenhanced MRA|
265120|NCT01344876|O2|Outcome|OPB-51602 2mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
265121|NCT01344876|O1|Outcome|OPB-51602 1m/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
265122|NCT01344876|O1|Outcome|OPB-51602|"OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle~OPB-51602: once daily during the treatment period"
265123|NCT01344876|O1|Outcome|OPB-51602|"OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle~OPB-51602: once daily during the treatment period"
265124|NCT01344876|E5|Reported Event|OPB-51602 6mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
265125|NCT01344876|E4|Reported Event|OPB-51602 4mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
265126|NCT01344876|E3|Reported Event|OPB-51602 3mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
265127|NCT01344876|E2|Reported Event|OPB-51602 2mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
265128|NCT01344876|E1|Reported Event|OPB-51602 1mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
265129|NCT01344824|B1|Baseline|Single Arm Trial|"Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride~bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).~carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)~erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)~pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)"
265130|NCT01344824|P1|Participant Flow|Bevacizumab, Carboplatin, and Pemetrexed Disodium, With Option|"Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride~bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).~carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)~erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)~pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)"
265131|NCT01344824|O1|Outcome|Bevacizumab, Carboplatin, and Pemetrexed Disodium, With Option|"Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride~bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).~carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)~erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)~pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)"
265132|NCT01344824|O1|Outcome|Single Arm Trial|"Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride~bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).~carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)~erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)~pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)"
265133|NCT01344824|O1|Outcome|Single Arm Trial|"Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride~bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).~carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)~erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)~pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)"
265134|NCT01344824|E1|Reported Event|Single Arm Trial|"Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride~bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).~carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)~erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)~pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)"
265135|NCT01344759|B3|Baseline|Total|Total of all reporting groups
265136|NCT01344759|B2|Baseline|Dexmedetomidine|Dexmedetomidine: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.
265137|NCT01344759|B1|Baseline|Propofol|Propofol: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.
265138|NCT01344759|P2|Participant Flow|Dexmedetomidine|Dexmedetomidine: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.
265139|NCT01344759|P1|Participant Flow|Propofol|Propofol: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.
265140|NCT01344759|O6|Outcome|Severe OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
265141|NCT01344759|O5|Outcome|Severe OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
265142|NCT01344759|O4|Outcome|Moderate OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
265143|NCT01344759|O3|Outcome|Moderate OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
265144|NCT01344759|O2|Outcome|Mild OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
265145|NCT01344759|O1|Outcome|Mild OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
265236|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
265237|NCT01344460|O3|Outcome|Computed Tomographic Angiography|
265146|NCT01344759|O6|Outcome|Severe OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
265147|NCT01344759|O5|Outcome|Severe OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
265148|NCT01344759|O4|Outcome|Moderate OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
265149|NCT01344759|O3|Outcome|Moderate OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
265150|NCT01344759|O2|Outcome|Mild OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
265151|NCT01344759|O1|Outcome|Mild OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
265152|NCT01344759|O6|Outcome|Severe OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
265153|NCT01344759|O5|Outcome|Severe OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
265154|NCT01344759|O4|Outcome|Moderate OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
265155|NCT01344759|O3|Outcome|Moderate OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
265156|NCT01344759|O2|Outcome|Mild OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
265157|NCT01344759|O1|Outcome|Mild OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
265158|NCT01344759|O6|Outcome|Severe OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
265159|NCT01344759|O5|Outcome|Severe OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
265160|NCT01344759|O4|Outcome|Moderate OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
265161|NCT01344759|O3|Outcome|Moderate OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
265162|NCT01344759|O2|Outcome|Mild OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
265163|NCT01344759|O1|Outcome|Mild OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
265164|NCT01344759|O2|Outcome|Dexmedetomidine|"Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump (low dose). Baseline airway images are obtained during this time.~If a subject moves during baseline images a bolus of DEX 0.5 mcg/kg will be given over 3 minutes and infusion rate will be increased to 1.5 mcg/kg/hr. If the subject moves a second time the research study will be terminated and patient will be under care of clinical team.~After the initial set of airway images are obtained, a 2 mcg/kg bolus of DEX will be given over 10 minutes followed by an increase in the infusion rate to 3 mcg/kg/hr (high dose)."
265165|NCT01344759|O1|Outcome|Propofol|"Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump (Low dose). Baseline airway images are obtained during this time.~If a subject moves during baseline images a bolus of Propofol 0.5 mcg/kg will be given over 10 seconds and infusion rate will be increased to 120 mcg/kg/hr. If the subject moves a second time the research study will be terminated and patient will be under care of clinical team.~After the initial set of airway images are obtained, a bolus dose of propofol 2 mcg/kg will be given over 2 minutes followed by an increase in the infusion rate to 200 mcg/kg/hr (high dose)."
265166|NCT01344759|E2|Reported Event|Dexmedetomidine|Dexmedetomidine: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.
265167|NCT01344759|E1|Reported Event|Propofol|Propofol: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.
265168|NCT01344629|B3|Baseline|Total|Total of all reporting groups
265169|NCT01344629|B2|Baseline|Treatment Sequence B|
265170|NCT01344629|B1|Baseline|Treatment Sequence A|
265171|NCT01344629|P2|Participant Flow|Treatment Sequence B|Concomitant use, T80/A 5mg FDC tablet, T80/A 5mg FDC tablet, Concomitant use
265172|NCT01344629|P1|Participant Flow|Treatment Sequence A|T80/A 5mg FDC tablet, Concomitant use, Concomitant use, T80/A 5mg FDC tablet
265173|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
265174|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
265175|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
265176|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
265177|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
265178|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
265179|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
265180|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
265181|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
265182|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
265183|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
265184|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
265185|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
265186|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
265187|NCT01344629|E2|Reported Event|Treatment Sequence B|Concomitant use, T80/A 5mg FDC tablet, T80/A 5mg FDC tablet, Concomitant use
265188|NCT01344629|E1|Reported Event|Treatment Sequence A|T80/A 5mg FDC tablet, Concomitant use, Concomitant use, T80/A 5mg FDC tablet
265189|NCT01344616|B3|Baseline|Total|Total of all reporting groups
265190|NCT01344616|B2|Baseline|Lifestyle Counseling|"computer-based clinical support to patient~lifestyle support: computer-based lifestyle improvement support and clinician support"
265191|NCT01344616|B1|Baseline|Usual Clinical Care|usual clinical care with no intervention
265192|NCT01344616|P2|Participant Flow|Lifestyle Counseling|"computer-based clinical support to patient~lifestyle support: computer-based lifestyle improvement support and clinician support"
265193|NCT01344616|P1|Participant Flow|Usual Clinical Care|usual clinical care with no intervention
265194|NCT01344616|O2|Outcome|Lifestyle Counseling|"computer-based clinical support to patient~lifestyle support: computer-based lifestyle improvement support and clinician support"
265195|NCT01344616|O1|Outcome|Usual Clinical Care|usual clinical care with no intervention
265196|NCT01344616|E2|Reported Event|Lifestyle Counseling|"computer-based clinical support to patient~lifestyle support: computer-based lifestyle improvement support and clinician support"
265197|NCT01344616|E1|Reported Event|Usual Clinical Care|usual clinical care with no intervention
265198|NCT01344538|B3|Baseline|Total|Total of all reporting groups
265199|NCT01344538|B2|Baseline|Lactose Capsule|Placebo Capsule : 2.0 g per day
265200|NCT01344538|B1|Baseline|Ginger Root Extract|Ginger Root Extract (Pure Encapsulations) : 2.0 g per day (10:1 extract)
265201|NCT01344538|P2|Participant Flow|Lactose Capsule|Placebo Capsule : 2.0 g per day
265202|NCT01344538|P1|Participant Flow|Ginger Root Extract|Ginger Root Extract (Pure Encapsulations) : 2.0 g per day (10:1 extract)
265203|NCT01344538|O2|Outcome|Ginger Root Extract|Ginger Root Extract (Pure Encapsulations) : 2.0 g per day (10:1 extract)
265204|NCT01344538|O1|Outcome|Lactose Capsule|Placebo Capsule : 2.0 g per day
265205|NCT01344538|E2|Reported Event|Lactose Capsule|Placebo Capsule: 2.0 g per day
265206|NCT01344538|E1|Reported Event|Ginger Root Extract|Ginger Root Extract (Pure Encapsulations): 2.0 g per day (10:1 extract)
265207|NCT01344460|B1|Baseline|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 mmol/kg body weight (bw) by single intravenous (i.v.) bolus injection. During the course of the study, non-contrast magnetic resonance angiography (MRA) images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
265208|NCT01344460|P1|Participant Flow|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 mmol/kg body weight (bw) by single intravenous (i.v.) bolus injection. During the course of the study, non-contrast magnetic resonance angiography (MRA) images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
265209|NCT01344460|O2|Outcome|Unenhanced MRA|
265210|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
265211|NCT01344460|O2|Outcome|Unenhanced MRA|
265212|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
265213|NCT01344460|O2|Outcome|Unenhanced MRA|
265214|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
265215|NCT01344460|O2|Outcome|Unenhanced MRA|
265216|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
265217|NCT01344460|O2|Outcome|Unenhanced MRA|
265218|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
265219|NCT01344460|O2|Outcome|Unenhanced MRA|
265220|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
265221|NCT01344460|O2|Outcome|Unenhanced MRA|
265222|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
265223|NCT01344460|O2|Outcome|Unenhanced MRA|
265224|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
265225|NCT01344460|O2|Outcome|Unenhanced MRA|
265226|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
265227|NCT01344460|O2|Outcome|Unenhanced MRA|
265228|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
265229|NCT01344460|O2|Outcome|Unenhanced MRA|
265251|NCT01344460|E1|Reported Event|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 mmol/kg body weight (bw) by single intravenous (i.v.) bolus injection. During the course of the study, non-contrast magnetic resonance angiography (MRA) images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
265252|NCT01344447|B1|Baseline|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 millimole per kilogram (mmol/kg) body weight (BW) by single intravenous (IV) bolus injection. During the course of the study, non-contrast MRA images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
265253|NCT01344447|P1|Participant Flow|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 millimole per kilogram (mmol/kg) body weight (BW) by single intravenous (IV) bolus injection. During the course of the study, non-contrast MRA images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
265254|NCT01344447|O2|Outcome|Unenhanced MRA|
265255|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
265256|NCT01344447|O2|Outcome|Unenhanced MRA|
265257|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
265258|NCT01344447|O2|Outcome|Unenhanced MRA|
265259|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
265260|NCT01344447|O2|Outcome|Unenhanced MRA|
265261|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
265262|NCT01344447|O2|Outcome|Unenhanced MRA|
265263|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
265264|NCT01344447|O2|Outcome|Unenhanced MRA|
265265|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
265266|NCT01344447|O2|Outcome|Unenhanced MRA|
265267|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
265268|NCT01344447|O2|Outcome|Unenhanced MRA|
265269|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
265270|NCT01344447|O2|Outcome|Unenhanced MRA|
265271|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
265272|NCT01344447|O2|Outcome|Unenhanced MRA|
265273|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
265274|NCT01344447|O2|Outcome|Unenhanced MRA|
265275|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
265276|NCT01344447|O2|Outcome|Unenhanced MRA|
265277|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
265278|NCT01344447|O2|Outcome|Unenhanced MRA|
265279|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
265280|NCT01344447|O2|Outcome|Unenhanced MRA|
265281|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
265282|NCT01344447|O3|Outcome|Computed Tomographic Angiography|
265283|NCT01344447|O2|Outcome|Unenhanced MRA|
265284|NCT01344447|O1|Outcome|Gadobutrol-Enhanced MRA|
265285|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
265286|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
265287|NCT01344447|O2|Outcome|Non-contrast MRA|
265288|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
265289|NCT01344447|O2|Outcome|Non-contrast MRA|
265290|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
265291|NCT01344447|O2|Outcome|Unenhanced MRA|
265292|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
265293|NCT01344447|E1|Reported Event|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 millimole per kilogram (mmol/kg) body weight (BW) by single intravenous (IV) bolus injection. During the course of the study, non-contrast MRA images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
265294|NCT01344369|B3|Baseline|Total|Total of all reporting groups
265295|NCT01344369|B2|Baseline|FEMCON® Fe (Reference) First|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in first period followed by 0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
265296|NCT01344369|B1|Baseline|Norethindrone/Ethinyl Estradiol (Test) First|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in first period followed by 0.4 mg/0.035 mg FEMCON® Fe Chewable Tablets reference product dosed in the second period.
265297|NCT01344369|P2|Participant Flow|FEMCON® Fe (Reference) First|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in first period followed by 0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
265298|NCT01344369|P1|Participant Flow|Norethindrone/Ethinyl Estradiol (Test) First|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in first period followed by 0.4 mg/0.035 mg FEMCON® Fe Chewable Tablets reference product dosed in the second period.
265299|NCT01344369|O2|Outcome|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
265300|NCT01344369|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
265301|NCT01344369|O2|Outcome|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
265302|NCT01344369|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
265303|NCT01344369|O2|Outcome|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
265304|NCT01344369|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
265305|NCT01344369|O2|Outcome|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
265306|NCT01344369|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
265307|NCT01344369|O2|Outcome|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
265308|NCT01344369|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
265309|NCT01344369|O2|Outcome|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
265310|NCT01344369|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
265311|NCT01344369|E2|Reported Event|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
265312|NCT01344369|E1|Reported Event|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
265313|NCT01344161|B3|Baseline|Total|Total of all reporting groups
265314|NCT01344161|B2|Baseline|Vitamin D|In vitamin D group women used a pill of 25 microgram cholecalciferol every day for 12-weeks.
265315|NCT01344161|B1|Baseline|Lactose|In placebo group women used a pill of 25 microgram lactose every day for 12-weeks.
265316|NCT01344161|P2|Participant Flow|Vitamin D|In vitamin D group women used a pill of 25 microgram cholecalciferol every day for 12-weeks.
265317|NCT01344161|P1|Participant Flow|Lactose|In placebo group women used a pill of 25 microgram lactose every day for 12-weeks.
265318|NCT01344161|O2|Outcome|Placebo|25 microgram lactose
265319|NCT01344161|O1|Outcome|Vitamin D|25 microgram cholecalciferol
265320|NCT01344161|O2|Outcome|Placebo|25 microgram lactose
265321|NCT01344161|O1|Outcome|Vitamin D|25 microgram cholecalciferol
265322|NCT01344161|O2|Outcome|Placebo|25 microgram lactose
265323|NCT01344161|O1|Outcome|Vitamin D|25 microgram cholecalciferol
265324|NCT01344161|O2|Outcome|Placebo|25 microgram lactose
265325|NCT01344161|O1|Outcome|Vitamin D|25 microgram cholecalciferol
265326|NCT01344161|E2|Reported Event|Vitamin D|In vitamin D group women used a pill of 25 microgram cholecalciferol every day for 12-weeks.
265327|NCT01344161|E1|Reported Event|Lactose|In placebo group women used a pill of 25 microgram lactose every day for 12-weeks.
265328|NCT01344057|B1|Baseline|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
265329|NCT01344057|P1|Participant Flow|FLUAD|Participants received a single intramuscular (IM) dose of 0.5 milliliter (mL) of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
265330|NCT01344057|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
265331|NCT01344057|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
265332|NCT01344057|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
265333|NCT01344057|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
265334|NCT01344057|E1|Reported Event|FLUAD|Participants received a single IM 0.5 mL dose of trivalent subunit inactivated adjuvanted influenza vaccine FLUAD during the vaccination visit, according to the study protocol (follow-up period: until day 22).
265335|NCT01343901|B1|Baseline|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
265336|NCT01343901|P1|Participant Flow|Bevacizumab|All participants with metastatic colorectal cancer (mCRC) with exclusively liver or liver and lung metastases for whom bevacizumab (Avastin) was administered as part of first line treatment for potentially resectable liver metastases as per treating physician discretion. All concomitant medications as used in daily routine clinical practice were allowed.
265337|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
265338|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
265339|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
265340|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
265341|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
265342|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
265343|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
265344|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
265345|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
265346|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
265347|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
265348|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
265349|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
265350|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
265351|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
265352|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
265353|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
265354|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
265355|NCT01343901|E1|Reported Event|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
265356|NCT01343888|B4|Baseline|Total|Total of all reporting groups
265357|NCT01343888|B3|Baseline|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
265358|NCT01343888|B2|Baseline|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
265359|NCT01343888|B1|Baseline|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
265360|NCT01343888|P3|Participant Flow|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
265361|NCT01343888|P2|Participant Flow|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24. Patients with ETS stopped all study medication at Week 24; patients without ETS subsequently received PegIFN/RBV alone up to Week 48.
265362|NCT01343888|P1|Participant Flow|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir (BI 201335) 120 mg once daily (oral) plus Pegylated Interferon-alpha (PegIFN)/ Ribavirin (RBV) (subcutaneous injection/oral) for 12 or 24 weeks, depending on achievement of early treatment success (ETS). Patients with ETS received this treatment for 12 weeks and subsequently PegIFN/RBV alone up to Week 24; patients without ETS received this treatment for 24 weeks and subsequently PegIFN/RBV alone up to Week 48.
265363|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
265364|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
265365|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
265366|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
265809|NCT01342523|B14|Baseline|no CIS/no Loz/Emails/Full Website/Brief Booklet|
265367|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
265368|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
265369|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
265370|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
265371|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
265372|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
265373|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
265374|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
265375|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
265376|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
265377|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
265378|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
265379|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
265380|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
265381|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
265382|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
265383|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
265384|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
265385|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
265386|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
265387|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
265388|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
265389|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
265390|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
265391|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
265392|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
265393|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
265394|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
265395|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
265396|NCT01343888|E3|Reported Event|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
265397|NCT01343888|E2|Reported Event|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
265398|NCT01343888|E1|Reported Event|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
265399|NCT01343823|B5|Baseline|Total|Total of all reporting groups
265400|NCT01343823|B4|Baseline|Placebo|
265401|NCT01343823|B3|Baseline|Ecallantide 60 mg|
265402|NCT01343823|B2|Baseline|Ecallantide 30 mg|
265403|NCT01343823|B1|Baseline|Ecallantide 10 mg|
265404|NCT01343823|P4|Participant Flow|Ecallantide 60mg|60 mg administered as two 30 mg SC injections of ecallantide
284513|NCT01288079|E4|Reported Event|Placebo|
265405|NCT01343823|P3|Participant Flow|Ecallantide 30 mg|30 mg administered as one 30 mg SC injection of ecallantide and one matching placebo
265406|NCT01343823|P2|Participant Flow|Ecallantide 10 mg|10 mg administered as one 10 mg SC injection of ecallantide and one matching placebo
265407|NCT01343823|P1|Participant Flow|Placebo|Administered by two subcutaneous injections.
265408|NCT01343823|O4|Outcome|Ecallantide 60 mg|
265409|NCT01343823|O3|Outcome|Ecallantide 30 mg|
265410|NCT01343823|O2|Outcome|Ecallantide 10 mg|
265411|NCT01343823|O1|Outcome|Placebo|
265412|NCT01343823|O4|Outcome|Ecallantide 60 mg|
265413|NCT01343823|O3|Outcome|Ecallantide 30 mg|
265414|NCT01343823|O2|Outcome|Ecallantide 10 mg|
265415|NCT01343823|O1|Outcome|Placebo|
265416|NCT01343823|E4|Reported Event|Placebo|
265417|NCT01343823|E3|Reported Event|Ecallantide 60 mg|
265418|NCT01343823|E2|Reported Event|Ecallantide 30 mg|
265419|NCT01343823|E1|Reported Event|Ecallantide 10 mg|
265420|NCT01343667|B3|Baseline|Total|Total of all reporting groups
265421|NCT01343667|B2|Baseline|GEF EPD|"Carotid artery stenting with Gore Embolic Filter~Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting"
265422|NCT01343667|B1|Baseline|GFRS EPD|"Carotid artery stenting with Gore Flow Reversal System~Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting"
265423|NCT01343667|P2|Participant Flow|GEF EPD|"Carotid artery stenting with Gore Embolic Filter~Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting"
265424|NCT01343667|P1|Participant Flow|GFRS EPD|"Carotid artery stenting with Gore Flow Reversal System~Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting"
265425|NCT01343667|O2|Outcome|GEF EPD|"Carotid artery stenting with Gore Embolic Filter embolic protection device~Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting"
265426|NCT01343667|O1|Outcome|GFRS EPD|"Carotid artery stenting with Gore Flow Reversal System embolic protection device~Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting"
265427|NCT01343667|E2|Reported Event|GEF EPD|"Carotid artery stenting with Gore Embolic Filter~Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting"
265428|NCT01343667|E1|Reported Event|GFRS EPD|"Carotid artery stenting with Gore Flow Reversal System~Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting"
265429|NCT01343485|B3|Baseline|Total|Total of all reporting groups
265430|NCT01343485|B2|Baseline|Intervention, Computer Reminder System|"Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine.~Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series"
265431|NCT01343485|B1|Baseline|Control, Standard Care for HPV Vaccine|Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol
265432|NCT01343485|P2|Participant Flow|Intervention, Computer Reminder System|"Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine.~Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series"
265433|NCT01343485|P1|Participant Flow|Control, Standard Care for HPV Vaccine|Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol
265434|NCT01343485|O2|Outcome|Intervention, Computer Reminder System|"Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine.~Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series"
265435|NCT01343485|O1|Outcome|Control, Standard Care for HPV Vaccine|Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol
265436|NCT01343485|E2|Reported Event|Intervention, Computer Reminder System|"Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine.~Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series"
265437|NCT01343485|E1|Reported Event|Control, Standard Care for HPV Vaccine|Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol
265438|NCT01343368|B3|Baseline|Total|Total of all reporting groups
265439|NCT01343368|B2|Baseline|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.~reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
265440|NCT01343368|B1|Baseline|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.~Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days~hematopoietic cell transplant: Conventional bone marrow transplant regimen."
265441|NCT01343368|P2|Participant Flow|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.~reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
265442|NCT01343368|P1|Participant Flow|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.~Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days~hematopoietic cell transplant: Conventional bone marrow transplant regimen."
265443|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.~reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
265444|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.~Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days~hematopoietic cell transplant: Conventional bone marrow transplant regimen."
265445|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.~reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
265446|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.~Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days~hematopoietic cell transplant: Conventional bone marrow transplant regimen."
265447|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.~reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
265448|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.~Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days~hematopoietic cell transplant: Conventional bone marrow transplant regimen."
265449|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.~reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
265450|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.~Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days~hematopoietic cell transplant: Conventional bone marrow transplant regimen."
265451|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.~reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
265452|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.~Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days~hematopoietic cell transplant: Conventional bone marrow transplant regimen."
265453|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.~reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
265454|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.~Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days~hematopoietic cell transplant: Conventional bone marrow transplant regimen."
265455|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.~reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
265456|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.~Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days~hematopoietic cell transplant: Conventional bone marrow transplant regimen."
265457|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.~reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
265458|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.~Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days~hematopoietic cell transplant: Conventional bone marrow transplant regimen."
265459|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.~reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
265460|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.~Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days~hematopoietic cell transplant: Conventional bone marrow transplant regimen."
265461|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.~reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
265462|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.~Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days~hematopoietic cell transplant: Conventional bone marrow transplant regimen."
265463|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.~reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
265464|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.~Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days~hematopoietic cell transplant: Conventional bone marrow transplant regimen."
265465|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.~reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
265466|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.~Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days~hematopoietic cell transplant: Conventional bone marrow transplant regimen."
265467|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.~reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
265468|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.~Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days~hematopoietic cell transplant: Conventional bone marrow transplant regimen."
265469|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.~reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
265470|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.~Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days~hematopoietic cell transplant: Conventional bone marrow transplant regimen."
265471|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.~reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
265472|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.~Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days~hematopoietic cell transplant: Conventional bone marrow transplant regimen."
265473|NCT01343368|E2|Reported Event|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.~reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
265474|NCT01343368|E1|Reported Event|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.~Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days~hematopoietic cell transplant: Conventional bone marrow transplant regimen."
265475|NCT01343277|B3|Baseline|Total|Total of all reporting groups
265476|NCT01343277|B2|Baseline|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
265477|NCT01343277|B1|Baseline|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
265478|NCT01343277|P2|Participant Flow|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
265599|NCT01343004|O1|Outcome|Placebo|"Placebo identical in appearance to BA058 study drug~Placebo: Placebo 0 mcg subcutaneous daily"
265479|NCT01343277|P1|Participant Flow|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
265480|NCT01343277|O2|Outcome|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
265481|NCT01343277|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
265482|NCT01343277|O2|Outcome|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
265483|NCT01343277|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
265484|NCT01343277|O2|Outcome|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
265485|NCT01343277|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
265486|NCT01343277|O2|Outcome|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
265487|NCT01343277|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
265488|NCT01343277|O2|Outcome|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
265489|NCT01343277|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
265490|NCT01343277|O2|Outcome|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
265491|NCT01343277|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
265492|NCT01343277|E2|Reported Event|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
265493|NCT01343277|E1|Reported Event|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
265494|NCT01343251|B3|Baseline|Total|Total of all reporting groups
265495|NCT01343251|B2|Baseline|Control|control group of non-HeRO patients who are evaluated but do not receive a HeRO graft for any reason
265496|NCT01343251|B1|Baseline|HeRO Graft|patients who are evaluated and receive a HeRO graft implant for hemodialysis
265497|NCT01343251|P2|Participant Flow|Control|control group of non-HeRO patients who are evaluated but do not receive a HeRO graft for any reason
265498|NCT01343251|P1|Participant Flow|HeRO Graft|patients who are evaluated and receive a Hemodialysis Reliable Outflow (HeRO) graft implant for hemodialysis
265499|NCT01343251|O2|Outcome|Control|HeRO eligible patients who did not receive a HeRO Graft
265500|NCT01343251|O1|Outcome|HeRO Graft|HeRO Graft recipients
265501|NCT01343251|O2|Outcome|Control|HeRO eligible patients who did not receive a HeRO Graft
265502|NCT01343251|O1|Outcome|HeRO Graft|HeRO Graft recipients
265503|NCT01343251|O2|Outcome|Control|HeRO eligible patients who did not receive a HeRO
265504|NCT01343251|O1|Outcome|HeRO Graft|HeRO Graft recipients
265505|NCT01343251|O2|Outcome|Control|HeRO eligible patients who did not receive HeRO
265506|NCT01343251|O1|Outcome|HeRO Graft|HeRO Graft recipients
265507|NCT01343251|O2|Outcome|Control|HeRO eligible patients who did not receive HeRO
265508|NCT01343251|O1|Outcome|HeRO Graft|HeRO Graft Recipients
265509|NCT01343251|E2|Reported Event|Control|HeRO eligible patients who did not receive a HeRO Graft
265510|NCT01343251|E1|Reported Event|HeRO Graft|HeRO Graft recipients
265511|NCT01343095|B4|Baseline|Total|Total of all reporting groups
265540|NCT01343082|P3|Participant Flow|Allocated to Tafluprost + Timolol|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5%.
284514|NCT01288079|E3|Reported Event|60 mg QD Duloxetine|
265512|NCT01343095|B3|Baseline|Earplugs and Headphones|"Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)~Noise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies."
265513|NCT01343095|B2|Baseline|Earplugs|"Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)"
265514|NCT01343095|B1|Baseline|Usual Care|Usual Care between 10pm-6am
265515|NCT01343095|P3|Participant Flow|Earplugs and Headphones|"Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)~Noise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies."
265516|NCT01343095|P2|Participant Flow|Earplugs|"Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)"
265517|NCT01343095|P1|Participant Flow|Usual Care|Usual Care between 10pm-6am
265518|NCT01343095|O3|Outcome|Earplugs and Headphones|"Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)~Noise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies."
265519|NCT01343095|O2|Outcome|Earplugs|"Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)"
265520|NCT01343095|O1|Outcome|Usual Care|Usual Care between 10pm-6am
265521|NCT01343095|O3|Outcome|Earplugs and Headphones|"Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)~Noise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies."
265522|NCT01343095|O2|Outcome|Earplugs|"Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)"
265523|NCT01343095|O1|Outcome|Usual Care|Usual Care between 10pm-6am
265524|NCT01343095|O3|Outcome|Earplugs and Headphones|"Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)~Noise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies."
265525|NCT01343095|O2|Outcome|Earplugs|"Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)"
265526|NCT01343095|O1|Outcome|Usual Care|Usual Care between 10pm-6am
265527|NCT01343095|O3|Outcome|Earplugs and Headphones|"Foam Earplugs and Noise canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)~Noise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies."
265528|NCT01343095|O2|Outcome|Earplugs|"Application of foam earplugs from 10pm-6am nightly for seven nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)"
265529|NCT01343095|O1|Outcome|Usual Care|Usual Care between 10pm-6am
265530|NCT01343095|O3|Outcome|Earplugs and Headphones|"Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)~Noise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies."
265531|NCT01343095|O2|Outcome|Earplugs|"Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)"
265532|NCT01343095|O1|Outcome|Usual Care|Usual Care between 10pm-6am
265533|NCT01343095|O3|Outcome|Earplugs and Headphones|"Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)~Noise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies."
265534|NCT01343095|O2|Outcome|Earplugs|"Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)"
265535|NCT01343095|O1|Outcome|Usual Care|Usual Care between 10pm-6am
265536|NCT01343095|E3|Reported Event|Earplugs and Headphones|"Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)~Noise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies."
265537|NCT01343095|E2|Reported Event|Earplugs|"Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.~Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)"
265538|NCT01343095|E1|Reported Event|Usual Care|Usual Care between 10pm-6am
265539|NCT01343082|B1|Baseline|DE-111|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation), Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation), or concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5% .
265689|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265541|NCT01343082|P2|Participant Flow|Allocated to Timolol|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation).
265542|NCT01343082|P1|Participant Flow|Allocated to Tafluprost|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation) .
265543|NCT01343082|O1|Outcome|DE-111|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation), Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation), or concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5% .
265544|NCT01343082|E1|Reported Event|DE-111|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation), Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation), or concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5% .
265545|NCT01343056|B5|Baseline|Total|Total of all reporting groups
265546|NCT01343056|B4|Baseline|Educator Support Follow up|"A diabetes educator will provide follow up support.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265547|NCT01343056|B3|Baseline|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265548|NCT01343056|B2|Baseline|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265549|NCT01343056|B1|Baseline|Office Staff Follow up of Diabetes Education|"A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265550|NCT01343056|P4|Participant Flow|Educator Support Follow up|A diabetes educator provided support to patients with periodic phone calls. Diabetes educators received training in ways to improve patient empowerment and best support their patients following diabetes education.
265551|NCT01343056|P3|Participant Flow|Usual Care|ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call was made by a diabetes educator.
265552|NCT01343056|P2|Participant Flow|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer met with the participant at their 6 week follow up visit and then called the participant monthly to monitor goal attainment."
265553|NCT01343056|P1|Participant Flow|Office Staff Follow up of Diabetes Education|A designee in the office shall be assigned to follow up with the patient for goal attainment. It was suggested that they phone the participant monthly. Staff also received training on how best to provide support to patients.
265554|NCT01343056|O4|Outcome|Educator Support Follow up|"A diabetes educator will provide follow up support and make monthly call to the patient to ascertain goal attainment.~Educator Support: Diabetes educators provided patient follow up support that was problem-focused and patient centered."
265555|NCT01343056|O3|Outcome|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.~Usual Care Support: Diabetes educators provided patient follow up support according to traditional clinical guidelines following completion of diabetes self-management."
265556|NCT01343056|O2|Outcome|Peer Follow up Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.~Peer Support: Community peers trained to provide diabetes support were tasked to follow up with patients via phone following completion of diabetes self-management education."
265557|NCT01343056|O1|Outcome|Office Staff Follow up Education|"A designee in the office staff shall be assigned to follow up with the patient for goal attainment. The office staff will call patients monthly to monitor goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.~Office Staff Support: Office staff of primary care practices trained to provide diabetes support were tasked to follow up with patients via phone following completion of diabetes self-management education."
265558|NCT01343056|O4|Outcome|Educator Support Follow up|"A diabetes educator will provide follow up support.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265559|NCT01343056|O3|Outcome|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265596|NCT01343004|P1|Participant Flow|Placebo|"Placebo identical in appearance to BA058 study drug~Placebo: Placebo 0 mcg subcutaneous daily"
265597|NCT01343004|O3|Outcome|Teriparatide|"Blinded until after randomization, then open-label~teriparatide: teriparatide 20 mcg subcutaneous daily"
265598|NCT01343004|O2|Outcome|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
265560|NCT01343056|O2|Outcome|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265561|NCT01343056|O1|Outcome|Office Staff Follow up of Diabetes Education|"A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265562|NCT01343056|O4|Outcome|Educator Support Follow up|"A diabetes educator will provide follow up support and make monthly call to the patient to ascertain goal attainment.~Educator Support: Diabetes educators provided patient follow up support that was problem-focused and patient centered."
265563|NCT01343056|O3|Outcome|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.~Usual Care Support: Diabetes educators provided patient follow up support according to traditional clinical guidelines following completion of diabetes self-management."
265564|NCT01343056|O2|Outcome|Peer Follow up Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.~Peer Support: Community peers trained to provide diabetes support were tasked to follow up with patients via phone following completion of diabetes self-management education."
265565|NCT01343056|O1|Outcome|Office Staff Follow up Education|"A designee in the office staff shall be assigned to follow up with the patient for goal attainment. The office staff will call patients monthly to monitor goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.~Office Staff Support: Office staff of primary care practices trained to provide diabetes support were tasked to follow up with patients via phone following completion of diabetes self-management education."
265566|NCT01343056|O4|Outcome|Educator Support Follow up|"A diabetes educator will provide follow up support.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265567|NCT01343056|O3|Outcome|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265568|NCT01343056|O2|Outcome|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265569|NCT01343056|O1|Outcome|Office Staff Follow up of Diabetes Education|"A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265570|NCT01343056|O4|Outcome|Educator Support Follow up|"A diabetes educator will provide follow up support.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265571|NCT01343056|O3|Outcome|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265572|NCT01343056|O2|Outcome|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265573|NCT01343056|O1|Outcome|Office Staff Follow up of Diabetes Education|"A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265574|NCT01343056|O4|Outcome|Educator Support Follow up|"A diabetes educator will provide follow up support.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265575|NCT01343056|O3|Outcome|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
284515|NCT01288079|E2|Reported Event|4 mg BID TC-5214|
265576|NCT01343056|O2|Outcome|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265577|NCT01343056|O1|Outcome|Office Staff Follow up of Diabetes Education|"A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265578|NCT01343056|O4|Outcome|Educator Support Follow up|"A diabetes educator will provide follow up support and make monthly call to the patient to ascertain goal attainment.~Educator Support: Diabetes educators provided patient follow up support that was problem-focused and patient centered."
265579|NCT01343056|O3|Outcome|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.~Usual Care Support: Diabetes educators provided patient follow up support according to traditional clinical guidelines following completion of diabetes self-management."
265580|NCT01343056|O2|Outcome|Peer Follow up Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.~Peer Support: Community peers trained to provide diabetes support were tasked to follow up with patients via phone following completion of diabetes self-management education."
265581|NCT01343056|O1|Outcome|Office Staff Follow up Education|"A designee in the office staff shall be assigned to follow up with the patient for goal attainment. The office staff will call patients monthly to monitor goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.~Office Staff Support: Office staff of primary care practices trained to provide diabetes support were tasked to follow up with patients via phone following completion of diabetes self-management education."
265582|NCT01343056|O4|Outcome|Educator Support Follow up|"A diabetes educator will provide follow up support.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265583|NCT01343056|O3|Outcome|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265584|NCT01343056|O2|Outcome|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265585|NCT01343056|O1|Outcome|Office Staff Follow up of Diabetes Education|"A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265586|NCT01343056|E4|Reported Event|Educator Support Follow up|"A diabetes educator will provide follow up support.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265587|NCT01343056|E3|Reported Event|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265588|NCT01343056|E2|Reported Event|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265589|NCT01343056|E1|Reported Event|Office Staff Follow up of Diabetes Education|"A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
265590|NCT01343004|B4|Baseline|Total|Total of all reporting groups
265591|NCT01343004|B3|Baseline|Teriparatide|"Blinded until after randomization, then open-label~teriparatide: teriparatide 20 mcg subcutaneous daily"
265592|NCT01343004|B2|Baseline|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
265593|NCT01343004|B1|Baseline|Placebo|"Placebo identical in appearance to BA058 study drug~Placebo: Placebo 0 mcg subcutaneous daily"
265594|NCT01343004|P3|Participant Flow|Teriparatide|"Blinded until after randomization, then open-label~teriparatide: teriparatide 20 mcg subcutaneous daily"
265595|NCT01343004|P2|Participant Flow|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
265794|NCT01342523|B29|Baseline|No CIS/Loz/Emails/Full Website/Full Booklet|
265600|NCT01343004|O3|Outcome|Teriparatide|"Blinded until after randomization, then open-label~teriparatide: teriparatide 20 mcg subcutaneous daily"
265601|NCT01343004|O2|Outcome|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
265602|NCT01343004|O1|Outcome|Placebo|"Placebo identical in appearance to BA058 study drug~Placebo: Placebo 0 mcg subcutaneous daily"
265603|NCT01343004|O3|Outcome|Teriparatide|"Blinded until after randomization, then open-label~teriparatide: teriparatide 20 mcg subcutaneous daily"
265604|NCT01343004|O2|Outcome|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
265605|NCT01343004|O1|Outcome|Placebo|"Placebo identical in appearance to BA058 study drug~Placebo: Placebo 0 mcg subcutaneous daily"
265606|NCT01343004|O3|Outcome|Teriparatide|"Blinded until after randomization, then open-label~teriparatide: teriparatide 20 mcg subcutaneous daily"
265607|NCT01343004|O2|Outcome|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
265608|NCT01343004|O1|Outcome|Placebo|"Placebo identical in appearance to BA058 study drug~Placebo: Placebo 0 mcg subcutaneous daily"
265609|NCT01343004|O3|Outcome|Teriparatide|"Blinded until after randomization, then open-label~teriparatide: teriparatide 20 mcg subcutaneous daily"
265610|NCT01343004|O2|Outcome|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
265611|NCT01343004|O1|Outcome|Placebo|"Placebo identical in appearance to BA058 study drug~Placebo: Placebo 0 mcg subcutaneous daily"
265612|NCT01343004|O3|Outcome|Teriparatide|"Blinded until after randomization, then open-label~teriparatide: teriparatide 20 mcg subcutaneous daily"
265613|NCT01343004|O2|Outcome|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
265614|NCT01343004|O1|Outcome|Placebo|"Placebo identical in appearance to BA058 study drug~Placebo: Placebo 0 mcg subcutaneous daily"
265615|NCT01343004|E3|Reported Event|Teriparatide|"Blinded until after randomization, then open-label~teriparatide: teriparatide 20 mcg subcutaneous daily"
265616|NCT01343004|E2|Reported Event|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
265617|NCT01343004|E1|Reported Event|Placebo|"Placebo identical in appearance to BA058 study drug~Placebo: Placebo 0 mcg subcutaneous daily"
265618|NCT01342965|B3|Baseline|Total|Total of all reporting groups
265619|NCT01342965|B2|Baseline|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
265620|NCT01342965|B1|Baseline|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
265621|NCT01342965|P2|Participant Flow|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
265622|NCT01342965|P1|Participant Flow|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
265623|NCT01342965|O2|Outcome|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
265624|NCT01342965|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
265625|NCT01342965|O2|Outcome|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
265626|NCT01342965|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
265627|NCT01342965|O2|Outcome|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
265628|NCT01342965|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
265629|NCT01342965|O2|Outcome|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
265630|NCT01342965|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
265631|NCT01342965|O2|Outcome|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
265632|NCT01342965|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
265633|NCT01342965|E2|Reported Event|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
265634|NCT01342965|E1|Reported Event|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
265635|NCT01342926|B5|Baseline|Total|Total of all reporting groups
265636|NCT01342926|B4|Baseline|GSK933776 15 mg/kg|15 mg/kg administration of GSK933776 via intravenous infusion
265637|NCT01342926|B3|Baseline|GSK933776 6 mg/kg|6 mg/kg administration of GSK933776 via intravenous infusion
265638|NCT01342926|B2|Baseline|GSK933776 3 mg/kg|3 mg/kg administration of GSK933776 via intravenous infusion
265639|NCT01342926|B1|Baseline|Placebo|Placebo via intravenous infusion
265640|NCT01342926|P4|Participant Flow|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265641|NCT01342926|P3|Participant Flow|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265642|NCT01342926|P2|Participant Flow|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
265795|NCT01342523|B28|Baseline|CIS/Loz/Emails/Lite Website/Full Booklet|
265643|NCT01342926|P1|Participant Flow|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
265644|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265645|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265646|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
265647|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
265648|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265649|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265650|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
265651|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
265652|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265653|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265654|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
265655|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
265656|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265657|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265658|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
265659|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
265660|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265661|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265662|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
265663|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
265664|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265665|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265666|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
265667|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
265668|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265669|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265670|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
265671|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
265672|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265673|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265674|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
265675|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
265676|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265677|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265678|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
265679|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
265680|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265681|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265682|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
265683|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
265684|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265685|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265686|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
265687|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
265688|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265690|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
265691|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
265692|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265693|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265694|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
265695|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
265696|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265697|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265698|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
265699|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
265700|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265701|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265702|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
265703|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
265704|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265705|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265706|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
265707|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
265708|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265709|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265710|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
265711|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
265712|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265713|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265714|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
265715|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
265716|NCT01342926|E4|Reported Event|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265717|NCT01342926|E3|Reported Event|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
265718|NCT01342926|E2|Reported Event|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
265719|NCT01342926|E1|Reported Event|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
265720|NCT01342913|B3|Baseline|Total|Total of all reporting groups
265721|NCT01342913|B2|Baseline|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
265722|NCT01342913|B1|Baseline|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
265723|NCT01342913|P3|Participant Flow|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
265724|NCT01342913|P2|Participant Flow|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
265725|NCT01342913|P1|Participant Flow|Placebo + Salbutamol|Participants were instructed to take single-blind placebo (ACCUHALER/DISKUS and Novel Dry Powder Inhaler [NDPI]): one inhalation each morning from each device, and one inhalation from the ACCUHALER/DISKUS in the evening. In addition, all participants received supplemental albuterol (salbutamol) (metered dose inhaler [MDI] and/or nebules) to be used on an as-needed basis. Ipratropium bromide alone was permitted, provided that the participant was on a stable dose from Visit 1 (Screening) and remained on the stable dose throughout the study; however, ipratropium must have been withheld for 4 hours prior to and during each clinic visit.
265796|NCT01342523|B27|Baseline|CIS/Loz/Emails/Full Website/Brief Booklet|
265797|NCT01342523|B26|Baseline|no CIS/no Loz/Emails/Full Website/Full Booklet|
265798|NCT01342523|B25|Baseline|No CIS/Loz/no Emails/Full Website/Full Booklet|
265726|NCT01342913|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
265727|NCT01342913|O1|Outcome|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
265728|NCT01342913|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
265729|NCT01342913|O1|Outcome|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
265730|NCT01342913|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
265731|NCT01342913|O1|Outcome|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
265732|NCT01342913|E2|Reported Event|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
265733|NCT01342913|E1|Reported Event|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
265734|NCT01342887|B1|Baseline|Treatment (Immunosuppression, Enzyme Inhibitor, and Chemo)|"Patients receive cyclosporine IV continuously on days 5-9. Patients also receive pravastatin sodium PO every 6 hours on days 1-10, etoposide IV continuously on days 5-9, and mitoxantrone hydrochloride IV continuously on days 5-9. Treatment repeats for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR/CRi may receive 2 additional courses in the absence of disease progression or unacceptable toxicity.~cyclosporine: Given IV~pravastatin sodium: Given PO~mitoxantrone hydrochloride: Given IV~etoposide: Given IV~bone marrow aspiration: Correlative studies"
265735|NCT01342887|P1|Participant Flow|Treatment (Immunosuppression, Enzyme Inhibitor, and Chemo)|"Patients receive cyclosporine IV continuously on days 5-9. Patients also receive pravastatin sodium PO every 6 hours on days 1-10, etoposide IV continuously on days 5-9, and mitoxantrone hydrochloride IV continuously on days 5-9. Treatment repeats for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR/CRi may receive 2 additional courses in the absence of disease progression or unacceptable toxicity.~cyclosporine: Given IV~pravastatin sodium: Given PO~mitoxantrone hydrochloride: Given IV~etoposide: Given IV~bone marrow aspiration: Correlative studies"
265736|NCT01342887|O1|Outcome|Treatment (Immunosuppression, Enzyme Inhibitor, and Chemo)|"Patients receive cyclosporine IV continuously on days 5-9. Patients also receive pravastatin sodium PO every 6 hours on days 1-10, etoposide IV continuously on days 5-9, and mitoxantrone hydrochloride IV continuously on days 5-9. Treatment repeats for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR/CRi may receive 2 additional courses in the absence of disease progression or unacceptable toxicity.~cyclosporine: Given IV~pravastatin sodium: Given PO~mitoxantrone hydrochloride: Given IV~etoposide: Given IV~bone marrow aspiration: Correlative studies"
265737|NCT01342887|O1|Outcome|Treatment (Immunosuppression, Enzyme Inhibitor, and Chemo)|"Patients receive cyclosporine IV continuously on days 5-9. Patients also receive pravastatin sodium PO every 6 hours on days 1-10, etoposide IV continuously on days 5-9, and mitoxantrone hydrochloride IV continuously on days 5-9. Treatment repeats for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR/CRi may receive 2 additional courses in the absence of disease progression or unacceptable toxicity.~cyclosporine: Given IV~pravastatin sodium: Given PO~mitoxantrone hydrochloride: Given IV~etoposide: Given IV~bone marrow aspiration: Correlative studies"
265738|NCT01342887|O1|Outcome|Treatment (Immunosuppression, Enzyme Inhibitor, and Chemo)|"Patients receive cyclosporine IV continuously on days 5-9. Patients also receive pravastatin sodium PO every 6 hours on days 1-10, etoposide IV continuously on days 5-9, and mitoxantrone hydrochloride IV continuously on days 5-9. Treatment repeats for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR/CRi may receive 2 additional courses in the absence of disease progression or unacceptable toxicity.~cyclosporine: Given IV~pravastatin sodium: Given PO~mitoxantrone hydrochloride: Given IV~etoposide: Given IV~bone marrow aspiration: Correlative studies"
265739|NCT01342887|O1|Outcome|Treatment (Immunosuppression, Enzyme Inhibitor, and Chemo)|"Patients receive cyclosporine IV continuously on days 5-9. Patients also receive pravastatin sodium PO every 6 hours on days 1-10, etoposide IV continuously on days 5-9, and mitoxantrone hydrochloride IV continuously on days 5-9. Treatment repeats for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR/CRi may receive 2 additional courses in the absence of disease progression or unacceptable toxicity.~cyclosporine: Given IV~pravastatin sodium: Given PO~mitoxantrone hydrochloride: Given IV~etoposide: Given IV~bone marrow aspiration: Correlative studies"
265799|NCT01342523|B24|Baseline|No CIS/Loz/Emails/Lite Website/Full Booklet|
265800|NCT01342523|B23|Baseline|No CIS/Loz/Emails/Full Website/Brief Booklet|
265801|NCT01342523|B22|Baseline|CIS/no Loz/no Email/Full Website/Full Booklet|
265802|NCT01342523|B21|Baseline|CIS/no Loz/Emails/Lite Website/Full Booklet|
265740|NCT01342887|E1|Reported Event|Treatment (Immunosuppression, Enzyme Inhibitor, and Chemo)|"Patients receive cyclosporine IV continuously on days 5-9. Patients also receive pravastatin sodium PO every 6 hours on days 1-10, etoposide IV continuously on days 5-9, and mitoxantrone hydrochloride IV continuously on days 5-9. Treatment repeats for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR/CRi may receive 2 additional courses in the absence of disease progression or unacceptable toxicity.~cyclosporine: Given IV~pravastatin sodium: Given PO~mitoxantrone hydrochloride: Given IV~etoposide: Given IV~bone marrow aspiration: Correlative studies"
265741|NCT01342770|B1|Baseline|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
265742|NCT01342770|P1|Participant Flow|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
265743|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
265744|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
265745|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
265746|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
265747|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
265748|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
265749|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
265750|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
265751|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
265752|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
265753|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
265754|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
265755|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
265756|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
265757|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
265758|NCT01342770|E1|Reported Event|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
265759|NCT01342757|B1|Baseline|Arm I|"Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.~Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study."
265760|NCT01342757|P1|Participant Flow|Vorinostat and Temozolomide|"Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.~Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study."
265761|NCT01342757|O1|Outcome|Arm I|"Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.~Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study."
265762|NCT01342757|O1|Outcome|Arm I|"Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.~Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study."
265803|NCT01342523|B20|Baseline|CIS/no Loz/Emails/Full Website/Brief Booklet|
265804|NCT01342523|B19|Baseline|CIS/Loz/no Email/Lite Website/Full Booklet|
265805|NCT01342523|B18|Baseline|CIS/Loz/no Email/Full Website/Brief Booklet|
265806|NCT01342523|B17|Baseline|CIS/Loz/Emails/Lite Website/Brief Booklet|
265807|NCT01342523|B16|Baseline|no CIS/no Loz/no Email/Full Website/Full Booklet|
265808|NCT01342523|B15|Baseline|no CIS/no Loz/Emails/Lite Web/Full Booklet|
265763|NCT01342757|O1|Outcome|Arm I|"Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.~Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study."
265764|NCT01342757|O1|Outcome|Arm I|"Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.~Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study."
265765|NCT01342757|E1|Reported Event|Arm I|"Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.~Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study."
265766|NCT01342666|B3|Baseline|Total|Total of all reporting groups
265767|NCT01342666|B2|Baseline|Cucumber Consumption|Participants were randomized to receive 300 g of cucumber (control group).
265768|NCT01342666|B1|Baseline|Tomato Consumption|Participants were randomized to receive 300 g of uncooked tomato (2 daily roma tomatoes approximately).
265769|NCT01342666|P2|Participant Flow|Cucumber Consumption|Participants were randomized to receive 300 g of cucumber (control group).
265770|NCT01342666|P1|Participant Flow|Tomato Consumption|Participants were randomized to receive 300 g of uncooked tomato (2 daily roma tomatoes approximately).
265771|NCT01342666|O2|Outcome|Cucumber Consumption|Participants were randomized to receive 300 g of cucumber (control group).
265772|NCT01342666|O1|Outcome|Tomato Consumption|Participants were randomized to receive 300 g of uncooked tomato (2 daily roma tomatoes approximately).
265773|NCT01342666|E2|Reported Event|Cucumber Consumption|Participants were randomized to receive 300 g of cucumber (control group).
265774|NCT01342666|E1|Reported Event|Tomato Consumption|Participants were randomized to receive 300 g of uncooked tomato (2 daily roma tomatoes approximately).
265775|NCT01342640|B1|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual’s Hb level.
265776|NCT01342640|P1|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta (Mircera, Continuous Erythropoietin Receptor Activator [C.E.R.A]) at a starting dose of 1.2 micrograms per kilogram (mcg/kg) administered via subcutaneous (SC) injection every 4 weeks for 28 weeks. Doses were adjusted according to individual’s hemoglobin (Hb) level.
265777|NCT01342640|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual’s Hb level.
265778|NCT01342640|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual’s Hb level.
265779|NCT01342640|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual’s Hb level.
265780|NCT01342640|E1|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual’s Hb level.
265781|NCT01342549|B3|Baseline|Total|Total of all reporting groups
265782|NCT01342549|B2|Baseline|Arm 2|"naltrexone~Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day"
265783|NCT01342549|B1|Baseline|Arm 1|"sodium valproate~Valproate: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60mg per day. Usual dosage is between 1250mg to 2000mg per day"
265784|NCT01342549|P2|Participant Flow|Arm 2|"naltrexone~Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day"
265785|NCT01342549|P1|Participant Flow|Arm 1|"sodium valproate~Valproate: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60mg per day. Usual dosage is between 1250mg to 2000mg per day"
265786|NCT01342549|O2|Outcome|Arm 2|"naltrexone~Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day"
265787|NCT01342549|O1|Outcome|Arm 1|"sodium valproate~Valproate: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60mg per day. Usual dosage is between 1250mg to 2000mg per day"
265788|NCT01342549|E2|Reported Event|Arm 2|"naltrexone~Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day"
265789|NCT01342549|E1|Reported Event|Arm 1|"sodium valproate~Valproate: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60mg per day. Usual dosage is between 1250mg to 2000mg per day"
265790|NCT01342523|B33|Baseline|Total|Total of all reporting groups
265791|NCT01342523|B32|Baseline|CIS/Loz/Emails/Full Website/Full Booklet|
265792|NCT01342523|B31|Baseline|CIS/Loz/no Emails/Full Website/Full Booklet|
265793|NCT01342523|B30|Baseline|CIS/no Loz/Emails/Full Website/Full Booklet|
265810|NCT01342523|B13|Baseline|No CIS/Loz/No Emails/Full Website/Lite Booklet|
265811|NCT01342523|B12|Baseline|No CIS/Loz/No Emails/Lite Website/Full Booklet|
265812|NCT01342523|B11|Baseline|No CIS/Loz/Emails/Lite Website/Brief Booklet|
265813|NCT01342523|B10|Baseline|CIS/No Loz/no Email/Lite Website/Full Booklet|
265814|NCT01342523|B9|Baseline|CIS/No Loz/no Email/Full Website/Brief Booklet|
265815|NCT01342523|B8|Baseline|CIS/No Loz/Emails/Lite Website/Brief Booklet|
265816|NCT01342523|B7|Baseline|CIS/Loz/No Email/Lite Website/Brief Booklet|
265817|NCT01342523|B6|Baseline|No CIS/No Loz/No Email/Lite Website/Full Booklet|
265818|NCT01342523|B5|Baseline|No CIS/No Loz/No Email/Full Website/Brief Booklet|
265819|NCT01342523|B4|Baseline|No CIS/no Loz/Email/Lite Website/Brief Booklet|
265820|NCT01342523|B3|Baseline|no CIS/Loz/No Email/Lite Website/Brief Booklet|
265821|NCT01342523|B2|Baseline|CIS/No Loz/No Email/Lite Website/Brief Booklet|
265822|NCT01342523|B1|Baseline|No CIS/No Loz/No Email/Lite Website/Brief Booklet|
265823|NCT01342523|P32|Participant Flow|CIS/Loz/Emails/Full Website/Full Booklet|
265824|NCT01342523|P31|Participant Flow|CIS/Loz/no Emails/Full Website/Full Booklet|
265825|NCT01342523|P30|Participant Flow|CIS/no Loz/Emails/Full Website/Full Booklet|
265826|NCT01342523|P29|Participant Flow|No CIS/Loz/Emails/Full Website/Full Booklet|
265827|NCT01342523|P28|Participant Flow|CIS/Loz/Emails/Lite Website/Full Booklet|
265828|NCT01342523|P27|Participant Flow|CIS/Loz/Emails/Full Website/Brief Booklet|
265829|NCT01342523|P26|Participant Flow|no CIS/no Loz/Emails/Full Website/Full Booklet|
265830|NCT01342523|P25|Participant Flow|No CIS/Loz/no Emails/Full Website/Full Booklet|
265831|NCT01342523|P24|Participant Flow|No CIS/Loz/Emails/Lite Website/Full Booklet|
265832|NCT01342523|P23|Participant Flow|No CIS/Loz/Emails/Full Website/Brief Booklet|
265833|NCT01342523|P22|Participant Flow|CIS/no Loz/no Email/Full Website/Full Booklet|
265834|NCT01342523|P21|Participant Flow|CIS/no Loz/Emails/Lite Website/Full Booklet|
265835|NCT01342523|P20|Participant Flow|CIS/no Loz/Emails/Full Website/Brief Booklet|
265836|NCT01342523|P19|Participant Flow|CIS/Loz/no Email/Lite Website/Full Booklet|
265837|NCT01342523|P18|Participant Flow|CIS/Loz/no Email/Full Website/Brief Booklet|
265838|NCT01342523|P17|Participant Flow|CIS/Loz/Emails/Lite Website/Brief Booklet|
265839|NCT01342523|P16|Participant Flow|no CIS/no Loz/no Email/Full Website/Full Booklet|
265840|NCT01342523|P15|Participant Flow|no CIS/no Loz/Emails/Lite Web/Full Booklet|
265841|NCT01342523|P14|Participant Flow|no CIS/no Loz/Emails/Full Website/Brief Booklet|
265842|NCT01342523|P13|Participant Flow|No CIS/Loz/No Emails/Full Website/Lite Booklet|
265843|NCT01342523|P12|Participant Flow|No CIS/Loz/No Emails/Lite Website/Full Booklet|
265844|NCT01342523|P11|Participant Flow|No CIS/Loz/Emails/Lite Website/Brief Booklet|
265845|NCT01342523|P10|Participant Flow|CIS/No Loz/no Email/Lite Website/Full Booklet|
265846|NCT01342523|P9|Participant Flow|CIS/No Loz/no Email/Full Website/Brief Booklet|
265847|NCT01342523|P8|Participant Flow|CIS/No Loz/Emails/Lite Website/Brief Booklet|
265848|NCT01342523|P7|Participant Flow|CIS/Loz/No Email/Lite Website/Brief Booklet|
265849|NCT01342523|P6|Participant Flow|No CIS/No Loz/No Email/Lite Website/Full Booklet|
265850|NCT01342523|P5|Participant Flow|No CIS/No Loz/No Email/Full Website/Brief Booklet|
265851|NCT01342523|P4|Participant Flow|No CIS/no Loz/Email/Lite Website/Brief Booklet|
265852|NCT01342523|P3|Participant Flow|no CIS/Loz/No Email/Lite Website/Brief Booklet|
265853|NCT01342523|P2|Participant Flow|CIS/No Loz/No Email/Lite Website/Brief Booklet|
265854|NCT01342523|P1|Participant Flow|No CIS/No Loz/No Email/Lite Website/Brief Booklet|
265855|NCT01342523|O10|Outcome|Brief Cessation Booklet|"Participants in the Full Cessation Booklet intervention group received a 12-page booklet developed by the investigators. The content of this booklet was the same as contained in the 36-page Clearing the Air booklet except that information directly relevant to coping skill training (identification of smoking triggers, making coping plans) was removed. Approximately half of the total sample of 1034 participants was randomized to receive the Brief Cessation Booklet; the other half received the Full Cessation Booklet."
265856|NCT01342523|O9|Outcome|Full Cessation Booklet|"Participants in the Full Cessation Booklet intervention group received the National Cancer Institute’s 36-page Clearing the Air brochure (www.smokefree.gov/pubs/clearing_the_air.pdf), containing a detailed guide for preparing to quit, quitting, and preventing relapse as well as suggested resources. Approximately half of the total sample of 1034 participants was randomized to receive the Full Cessation Booklet; the other half received a Brief Cessation Booklet."
265857|NCT01342523|O8|Outcome|Lite SmokeFree.Gov Website|Participants in the Lite SmokeFree.gov Website intervention group received received the “Lite” version of the website (developed by the investigators for this research) that included information about smoking and health such as benefits of quitting and information about withdrawal, medications and stress, but contained no interactive features or content that would support skill training. The look and graphics directly mirrored the full smokefree.gov website, but the number of web pages was reduced from over 50 to 16, and external links to resources were virtually eliminated. Approximately half of the total sample of 1034 participants was randomized to receive theLite SmokeFree.gov Website; the other half received the Full SmokeFree.gov Website.
265888|NCT01342484|P2|Participant Flow|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
265889|NCT01342484|P1|Participant Flow|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
265890|NCT01342484|O3|Outcome|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
265891|NCT01342484|O2|Outcome|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
265892|NCT01342484|O1|Outcome|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
265893|NCT01342484|O3|Outcome|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
265894|NCT01342484|O2|Outcome|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
265858|NCT01342523|O7|Outcome|Full SmokeFree.Gov Website|Participants in the Full SmokeFree.gov website intervention group received the standard smokefree.gov website content that included resources to motivate quitting and a step-by-step quitting guide that provided a skill-based intervention for preparing to quit, quitting, and maintaining abstinence. In addition, the active website offered encouragement and support, motivational information, and interactive features and referral links. The active website did not include direct interaction with users (e.g. live help) or interactive audio or video content. User-engagement features included task charts for behavior change, self-monitoring tools (e.g. for cravings and self-assessment), creation of a personal calendar, links to a quitline or to a counselor via text message for live help and social support through social media. No tailoring, feedback or outbound reminders were in use. Approximately half of the total sample of 1034 participants was randomized to receive the Full Smoke
265859|NCT01342523|O6|Outcome|No Email Messaging|Participants in this intervention group received no Email Messaging. Approximately half of the total sample of 1034 participants was randomized to receive no Email Messaging; the other half received 3 months of Email Messaging.
265860|NCT01342523|O5|Outcome|Email Messaging|Participants Email Messaging intervention group received brief email messages that could be accessed by any computer or mobile device that allowed email receipt. Messages were intended to provide: (1) Motivation/encouragement; (2) Quitting tips and information; (3) Adherence/education prompts (to use available resources as recommended), and (4) relapse prevention content. These emailed messages were sent twice/day for two weeks, once/day for an additional month, and then one every 3rd day for an additional 6 weeks (constituting a 3-month-long intervention). Approximately half of the total sample of 1034 participants was randomized to receive Email Messaging; the other half received no Email Messaging.
265861|NCT01342523|O4|Outcome|No Nicotine Replacement Therapy|Participants in this intervention group received no nicotine replacement therapy (NRT), i.e., no nicotine mini-lozenges. Approximately half of the total sample of 1034 participants was randomized to receive no NRT; the other half a 2-week supply of nicotine mini-lozenges.
265862|NCT01342523|O3|Outcome|Nicotine Replacement Therapy (NRT; Mini-Lozenge for 2 Weeks)|Participants in this intervention group received a 2-week starter package of nicotine mini-lozenges, with dose based on time to since first cigarette of the day as per package instructions. Each package contained 2 mini-lozenge dispensers (162 lozenges total) and instructions on proper use. Approximately half of the total sample of 1034 participants was randomized to receive the 2-week supply of mini-lozenges; the other half received no mini-lozenges.
265863|NCT01342523|O2|Outcome|"No Cancer Information Service Counseling (No CIS)"|"Participants in this intervention group did not receive telephone quitline counseling from the Cancer Information Service (CIS). This intervention group will be compared to an intervention group that did receive telephone quitline counseling from the CIS. The original randomization plan called for approximately half of the total sample of 1034 participants to be randomized to this intervention group (No CIS) and the other half to the CIS intervention group. However, due to a problem in the electronic transfer of data from the research coordinating site to CIS, 581 participants were randomized to No CIS group and 453 to the CIS group."
265864|NCT01342523|O1|Outcome|"Cancer Information Service Counseling (CIS)"|"Participants in this intervention group received telephone quitline counseling from the Cancer Information Service (CIS). These proactive calls initiated by CIS included an initial call (30 min), occurring within 3 days of enrollment, plus 4 additional counseling calls (up to 15 min each) scheduled to occur on the quit day or the day after, and then weekly for the next 3 weeks. The content of the counseling calls focused initially on motivating quitting and then setting a quit date, providing support, building self-efficacy, and skill training. The CIS intervention group will be compared to a No CIS group. The original randomization plan called for approximately half of the total sample of 1034 participants to be randomized to this intervention group (CIS) and the other half to the No CIS intervention group. However, due to a problem in the electronic transfer of data from the research coordinating site to CIS, 453 participants were randomized to CIS and 581 to the No CIS group."
265865|NCT01342523|E1|Reported Event|Lozenge|2 week supply of nicotine mini-lozenge. This is the only study arm for which adverse events were appropriate to be collected and analyzed, since all other arms did not involve interventions that could generate an adverse event report.
265866|NCT01342510|B5|Baseline|Total|Total of all reporting groups
265867|NCT01342510|B4|Baseline|Control|0.9% saline in a 10 cc syringe
265868|NCT01342510|B3|Baseline|Lidocaine/Magnesium|Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
265869|NCT01342510|B2|Baseline|Magnesium|Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
265870|NCT01342510|B1|Baseline|Lidocaine|Lidocaine 50 mg in a 10 cc syringe
265871|NCT01342510|P4|Participant Flow|Control|0.9% saline in a 10 cc syringe
265872|NCT01342510|P3|Participant Flow|Lidocaine/Magnesium|Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
265873|NCT01342510|P2|Participant Flow|Magnesium|Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
265874|NCT01342510|P1|Participant Flow|Lidocaine|Lidocaine 50 mg in a 10 cc syringe
265875|NCT01342510|O4|Outcome|Control|0.9% saline in a 10 cc syringe
265876|NCT01342510|O3|Outcome|Lidocaine/Magnesium|Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
265877|NCT01342510|O2|Outcome|Magnesium|Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
265878|NCT01342510|O1|Outcome|Lidocaine|Lidocaine 50 mg in a 10 cc syringe
265879|NCT01342510|E4|Reported Event|Control|0.9% saline in a 10 cc syringe
265880|NCT01342510|E3|Reported Event|Lidocaine/Magnesium|Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
265881|NCT01342510|E2|Reported Event|Magnesium|Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
265882|NCT01342510|E1|Reported Event|Lidocaine|Lidocaine 50 mg in a 10 cc syringe
265883|NCT01342484|B4|Baseline|Total|Total of all reporting groups
265884|NCT01342484|B3|Baseline|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
265885|NCT01342484|B2|Baseline|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
265886|NCT01342484|B1|Baseline|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
265887|NCT01342484|P3|Participant Flow|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
265895|NCT01342484|O1|Outcome|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
265896|NCT01342484|O3|Outcome|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
265897|NCT01342484|O2|Outcome|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
265898|NCT01342484|O1|Outcome|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
265899|NCT01342484|E3|Reported Event|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
265900|NCT01342484|E2|Reported Event|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
265901|NCT01342484|E1|Reported Event|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
265902|NCT01342471|B3|Baseline|Total|Total of all reporting groups
265903|NCT01342471|B2|Baseline|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
265904|NCT01342471|B1|Baseline|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
265905|NCT01342471|P2|Participant Flow|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
265906|NCT01342471|P1|Participant Flow|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
265907|NCT01342471|O2|Outcome|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
265908|NCT01342471|O1|Outcome|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
265909|NCT01342471|O2|Outcome|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
265920|NCT01342458|B2|Baseline|Control Group|During the intervention period, patients from the Control Group (CG) were instructed not to wear Moleca® or other similar minimalist footwear. During everyday activities, the CG group was only permitted to wear a standard, neutral tennis shoe. At the end of the intervention period, all CG participants also received one pair of Moleca® shoes at no cost.
265953|NCT01342445|O2|Outcome|LDX 30-mg|All participants receiving 30-mg LDX for 1 week in a double-blind, crossover design
265954|NCT01342445|O1|Outcome|Placebo|All participants receiving Placebo for 1 week in a double-blind, crossover design
265910|NCT01342471|O1|Outcome|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
265911|NCT01342471|O2|Outcome|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
265912|NCT01342471|O1|Outcome|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
265913|NCT01342471|O2|Outcome|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
265914|NCT01342471|O1|Outcome|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
265915|NCT01342471|O2|Outcome|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
265916|NCT01342471|O1|Outcome|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
265917|NCT01342471|E2|Reported Event|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
265918|NCT01342471|E1|Reported Event|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
265919|NCT01342458|B3|Baseline|Total|Total of all reporting groups
265952|NCT01342445|O3|Outcome|LDX 50-mg|All participants receiving 50-mg LDX for 1 week in a double-blind, crossover design
284516|NCT01288079|E1|Reported Event|1 mg BID TC-5214|
265921|NCT01342458|B1|Baseline|Intervention Group|Daily use of the intervention footwear (Moleca®) for 6 months, for at least 42 hours/week (approximately 6 hours/day, 7 days/week). The Moleca® shoe (Calçados Beira Rio S.A., Novo Hamburgo, Rio Grande do Sul, Brazil) is a low-cost women’s double canvas, flexible, flat, walking shoe without heels, with a 5-mm anti-slip rubber sole and a 3-mm flat insole of ethylene vinyl acetate that provides only protection but no correction. The mean weight of the shoe is 0.172±0.019 kg (range 0.091 to 0.182 kg), depending on size. This minimalist footwear is commonly worn by the elderly of all social classes and its average cost is US$ 6.25.
265922|NCT01342458|P2|Participant Flow|Control Group|During the intervention period, patients from the Control Group (CG) were instructed not to wear Moleca® or other similar minimalist footwear. During everyday activities, the CG group was only permitted to wear a standard, neutral tennis shoe. At the end of the intervention period, all CG participants also received one pair of Moleca® shoes at no cost.
265923|NCT01342458|P1|Participant Flow|Intervention Group|Daily use of the intervention footwear (Moleca®) for 6 months, for at least 42 hours/week (approximately 6 hours/day, 7 days/week). The Moleca® shoe (Calçados Beira Rio S.A., Novo Hamburgo, Rio Grande do Sul, Brazil) is a low-cost women’s double canvas, flexible, flat, walking shoe without heels, with a 5-mm anti-slip rubber sole and a 3-mm flat insole of ethylene vinyl acetate that provides only protection but no correction. The mean weight of the shoe is 0.172±0.019 kg (range 0.091 to 0.182 kg), depending on size. This minimalist footwear is commonly worn by the elderly of all social classes and its average cost is US$ 6.25.
265924|NCT01342458|O2|Outcome|Control Group|A rescue analgesic medication (paracetamol) was allowed only if necessary (2g/day max.)
265925|NCT01342458|O1|Outcome|Intervention Group|A rescue analgesic medication (paracetamol) was allowed only if necessary (2g/day max.)
265926|NCT01342458|O2|Outcome|Control Group|Knee adduction moment (KAM) first peak
265927|NCT01342458|O1|Outcome|Intervention Group|Knee adduction moment (KAM) first peak
265928|NCT01342458|O2|Outcome|Control Group|Six-minute walk test
265929|NCT01342458|O1|Outcome|Intervention Group|Six-minute walk test
265930|NCT01342458|O2|Outcome|Control Group|Global score of the Lequesne´s questionaire algo-functional.
265931|NCT01342458|O1|Outcome|Intervention Group|Global score of the Lequesne´s questionaire algo-functional.
265932|NCT01342458|O2|Outcome|Control Group|The WOMAC total score is the sum of all subscale (pain, function and stiffness).
265933|NCT01342458|O1|Outcome|Intervention Group|The WOMAC total score is the sum of all subscale (pain, function and stiffness).
265934|NCT01342458|O2|Outcome|Control Group|WOMAC Physical function subscale
265935|NCT01342458|O1|Outcome|Intervention Group|WOMAC Physical function subscale
265936|NCT01342458|O2|Outcome|Control Group|WOMAC stiffness subscale
265937|NCT01342458|O1|Outcome|Intervention Group|WOMAC stiffness subscale
265938|NCT01342458|O2|Outcome|Control Group|WOMAC pain subscale
265939|NCT01342458|O1|Outcome|Intervention Group|WOMAC pain subscale
265940|NCT01342458|E2|Reported Event|Control Group|During the intervention period, patients from the Control Group (CG) were instructed not to wear Moleca® or other similar minimalist footwear. During everyday activities, the CG group was only permitted to wear a standard, neutral tennis shoe. At the end of the intervention period, all CG participants also received one pair of Moleca® shoes at no cost.
265941|NCT01342458|E1|Reported Event|Intervention Group|Daily use of the intervention footwear (Moleca®) for 6 months, for at least 42 hours/week (approximately 6 hours/day, 7 days/week). The Moleca® shoe (Calçados Beira Rio S.A., Novo Hamburgo, Rio Grande do Sul, Brazil) is a low-cost women’s double canvas, flexible, flat, walking shoe without heels, with a 5-mm anti-slip rubber sole and a 3-mm flat insole of ethylene vinyl acetate that provides only protection but no correction. The mean weight of the shoe is 0.172±0.019 kg (range 0.091 to 0.182 kg), depending on size. This minimalist footwear is commonly worn by the elderly of all social classes and its average cost is US$ 6.25.
265942|NCT01342445|B3|Baseline|Total|Total of all reporting groups
265943|NCT01342445|B2|Baseline|Healthy Controls|All participants completed the Conners' Adult ADHD Rating Scales–Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning–Adult Version (BRIEF) at baseline only and received no drug.
265944|NCT01342445|B1|Baseline|ADHD Participants|All participants completed the Conners' Adult ADHD Rating Scales–Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning–Adult Version (BRIEF) at baseline and were randomly assigned to one of six medication orders using placebo, 30-mg, 50 and 70 mg LDX in the context of a double-blind, crossover design, with repeated measures at the end of each drug phase. Phase orders (following baseline) were assigned in a counterbalanced fashion across participants. To avoid starting any participant with the highest dosage, the 50-mg condition always preceded the 70-mg condition.
265945|NCT01342445|P2|Participant Flow|Attention-deficit/Hyperactivity Disorder (ADHD) Participants|All participants completed the Conners' Adult ADHD Rating Scales-Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning-Adult Version (BRIEF) at baseline and were randomly assigned to one of six medication orders using placebo, 30-mg, 50 and 70 mg lisdexamfetamine dimesylate (LDX) in the context of a double-blind, crossover design, with repeated measures at the end of each drug phase. Phase orders (following baseline) were assigned in a counterbalanced fashion across participants. To avoid starting any participant with the highest dosage, the 50-mg condition always preceded the 70-mg condition. Each phase was conducted for 1 week, and therefore, the total trial took place over 5 weeks and was able to be completed during a single semester. Participants ingested one pill per day on awakening.
265946|NCT01342445|P1|Participant Flow|Healthy Controls|All participants completed the Conners' Adult ADHD Rating Scales-Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning-Adult Version (BRIEF) at baseline only and received no drug.
265947|NCT01342445|O4|Outcome|LDX 70-mg|All participants receiving 70-mg LDX for 1 week in a double-blind, crossover design
265948|NCT01342445|O3|Outcome|LDX 50-mg|All participants receiving 50-mg LDX for 1 week in a double-blind, crossover design
265949|NCT01342445|O2|Outcome|LDX 30-mg|All participants receiving 30-mg LDX for 1 week in a double-blind, crossover design
265950|NCT01342445|O1|Outcome|Placebo|All participants receiving Placebo for 1 week in a double-blind, crossover design
265951|NCT01342445|O4|Outcome|LDX 70-mg|All participants receiving 70-mg LDX for 1 week in a double-blind, crossover design
265955|NCT01342445|E4|Reported Event|LDX 70-mg|All participants receiving 70-mg LDX for 1 week in a double-blind, crossover design
265956|NCT01342445|E3|Reported Event|LDX 50-mg|All participants receiving 50-mg LDX for 1 week in a double-blind, crossover design
265957|NCT01342445|E2|Reported Event|LDX 30-mg|All participants receiving 30-mg LDX for 1 week in a double-blind, crossover design
265958|NCT01342445|E1|Reported Event|Placebo|All participants receiving Placebo for 1 week in a double-blind, crossover design
265959|NCT01342341|B3|Baseline|Total|Total of all reporting groups
265960|NCT01342341|B2|Baseline|Placebo|"Group B Experimental: Forty moderate to heavy social alcohol users as described above will receive placebo x 14 days.~NOTE: This is a cross-over design and subjects will participate in both arms.~Parafon Forte: Drug: Parafon Forte administered at study visit~Other: Placebo administered at study visit"
265961|NCT01342341|B1|Baseline|Parafon Forte|"Experimental: Twenty moderate to heavy social alcohol users (women=10-25 drinks/week, men=14-30 drinks/week) will receive 250 mg of chlorzoxazone BID (500 mg/day) x 7 days followed by 500 mg of chlorzoxazone BID (1000 mg/day) x 7 days.~Twenty moderate to heavy social alcohol users as described above will receive 500 mg chlorzoxazone BID (1000 mg/day) x 7 days followed by 750 mg chlorzoxazone BID (1500 mg per day) x 7 days.~Parafon Forte: Drug: Parafon Forte administered at study visit~Other: Placebo administered at study visit"
265962|NCT01342341|P2|Participant Flow|Placebo|"Group B Experimental: Forty moderate to heavy social alcohol users as described above will receive placebo x 14 days.~NOTE: This is a cross-over design and subjects will participate in both arms.~Parafon Forte: Drug: Parafon Forte administered at study visit~Other: Placebo administered at study visit"
265963|NCT01342341|P1|Participant Flow|Parafon Forte|"Experimental: Twenty moderate to heavy social alcohol users (women=10-25 drinks/week, men=14-30 drinks/week) will receive 250 mg of chlorzoxazone BID (500 mg/day) x 7 days followed by 500 mg of chlorzoxazone BID (1000 mg/day) x 7 days.~Twenty moderate to heavy social alcohol users as described above will receive 500 mg chlorzoxazone BID (1000 mg/day) x 7 days followed by 750 mg chlorzoxazone BID (1500 mg per day) x 7 days.~Parafon Forte: Drug: Parafon Forte administered at study visit~Other: Placebo administered at study visit"
265964|NCT01342341|O2|Outcome|Placebo|"Group B Experimental: Twenty moderate to heavy social alcohol users as described above will receive placebo x 14 days.~NOTE: This is a cross-over design and subjects will participate in both arms.~Parafon Forte: Drug: Parafon Forte administered at study visit~Other: Placebo administered at study visit"
265965|NCT01342341|O1|Outcome|Parafon Forte|"Experimental: Twenty moderate to heavy social alcohol users (women=10-25 drinks/week, men=14-30 drinks/week) will receive 250 mg of chlorzoxazone BID (500 mg/day) x 7 days followed by 500 mg of chlorzoxazone BID (1000 mg/day) x 7 days.~Twenty moderate to heavy social alcohol users as described above will receive 500 mg chlorzoxazone BID (1000 mg/day) x 7 days followed by 750 mg chlorzoxazone BID (1500 mg per day) x 7 days.~Parafon Forte: Drug: Parafon Forte administered at study visit~Other: Placebo administered at study visit"
265966|NCT01342341|E2|Reported Event|Placebo|"Group B Experimental: Forty moderate to heavy social alcohol users as described above will receive placebo x 14 days.~NOTE: This is a cross-over design and subjects will participate in both arms.~Parafon Forte: Drug: Parafon Forte administered at study visit~Other: Placebo administered at study visit"
265967|NCT01342341|E1|Reported Event|Parafon Forte|"Experimental: Twenty moderate to heavy social alcohol users (women=10-25 drinks/week, men=14-30 drinks/week) will receive 250 mg of chlorzoxazone BID (500 mg/day) x 7 days followed by 500 mg of chlorzoxazone BID (1000 mg/day) x 7 days.~Twenty moderate to heavy social alcohol users as described above will receive 500 mg chlorzoxazone BID (1000 mg/day) x 7 days followed by 750 mg chlorzoxazone BID (1500 mg per day) x 7 days.~Parafon Forte: Drug: Parafon Forte administered at study visit~Other: Placebo administered at study visit"
265968|NCT01342211|B6|Baseline|Total|Total of all reporting groups
265969|NCT01342211|B5|Baseline|PF-04950615 6.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265970|NCT01342211|B4|Baseline|PF-04950615 3.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265971|NCT01342211|B3|Baseline|PF-04950615 1.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265972|NCT01342211|B2|Baseline|PF-04950615 0.25 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265973|NCT01342211|B1|Baseline|Placebo|Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265974|NCT01342211|P5|Participant Flow|PF-04950615 6.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265975|NCT01342211|P4|Participant Flow|PF-04950615 3.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265976|NCT01342211|P3|Participant Flow|PF-04950615 1.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265977|NCT01342211|P2|Participant Flow|PF-04950615 0.25 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265978|NCT01342211|P1|Participant Flow|Placebo|Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266064|NCT01342094|E1|Reported Event|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
265979|NCT01342211|O5|Outcome|PF-04950615 6.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265980|NCT01342211|O4|Outcome|PF-04950615 3.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265981|NCT01342211|O3|Outcome|PF-04950615 1.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265982|NCT01342211|O2|Outcome|PF-04950615 0.25 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265983|NCT01342211|O1|Outcome|Placebo|Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265984|NCT01342211|O5|Outcome|PF-04950615 6.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265985|NCT01342211|O4|Outcome|PF-04950615 3.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265986|NCT01342211|O3|Outcome|PF-04950615 1.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265987|NCT01342211|O2|Outcome|PF-04950615 0.25 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265988|NCT01342211|O1|Outcome|Placebo|Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265989|NCT01342211|O4|Outcome|PF-04950615 6.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265990|NCT01342211|O3|Outcome|PF-04950615 3.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265991|NCT01342211|O2|Outcome|PF-04950615 1.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265992|NCT01342211|O1|Outcome|PF-04950615 0.25 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265993|NCT01342211|O5|Outcome|PF-04950615 6.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265994|NCT01342211|O4|Outcome|PF-04950615 3.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265995|NCT01342211|O3|Outcome|PF-04950615 1.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265996|NCT01342211|O2|Outcome|PF-04950615 0.25 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265997|NCT01342211|O1|Outcome|Placebo|Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265998|NCT01342211|O5|Outcome|PF-04950615 6.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
265999|NCT01342211|O4|Outcome|PF-04950615 3.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266000|NCT01342211|O3|Outcome|PF-04950615 1.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266001|NCT01342211|O2|Outcome|PF-04950615 0.25 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266002|NCT01342211|O1|Outcome|Placebo|Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266003|NCT01342211|O5|Outcome|PF-04950615 6.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266004|NCT01342211|O4|Outcome|PF-04950615 3.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266005|NCT01342211|O3|Outcome|PF-04950615 1.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266006|NCT01342211|O2|Outcome|PF-04950615 0.25 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266007|NCT01342211|O1|Outcome|Placebo|Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266008|NCT01342211|O5|Outcome|PF-04950615 6.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266009|NCT01342211|O4|Outcome|PF-04950615 3.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266010|NCT01342211|O3|Outcome|PF-04950615 1.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266011|NCT01342211|O2|Outcome|PF-04950615 0.25 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266012|NCT01342211|O1|Outcome|Placebo|Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266013|NCT01342211|O5|Outcome|PF-04950615 6.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266014|NCT01342211|O4|Outcome|PF-04950615 3.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266015|NCT01342211|O3|Outcome|PF-04950615 1.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266016|NCT01342211|O2|Outcome|PF-04950615 0.25 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266017|NCT01342211|O1|Outcome|Placebo|Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266018|NCT01342211|O5|Outcome|PF-04950615 6.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266019|NCT01342211|O4|Outcome|PF-04950615 3.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266020|NCT01342211|O3|Outcome|PF-04950615 1.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266021|NCT01342211|O2|Outcome|PF-04950615 0.25 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266022|NCT01342211|O1|Outcome|Placebo|Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266023|NCT01342211|O5|Outcome|PF-04950615 6.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266024|NCT01342211|O4|Outcome|PF-04950615 3.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266025|NCT01342211|O3|Outcome|PF-04950615 1.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266026|NCT01342211|O2|Outcome|PF-04950615 0.25 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266027|NCT01342211|O1|Outcome|Placebo|Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266028|NCT01342211|O5|Outcome|PF-04950615 6.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266029|NCT01342211|O4|Outcome|PF-04950615 3.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266030|NCT01342211|O3|Outcome|PF-04950615 1.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266031|NCT01342211|O2|Outcome|PF-04950615 0.25 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266032|NCT01342211|O1|Outcome|Placebo|Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266033|NCT01342211|O5|Outcome|PF-04950615 6.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266034|NCT01342211|O4|Outcome|PF-04950615 3.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266035|NCT01342211|O3|Outcome|PF-04950615 1.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266036|NCT01342211|O2|Outcome|PF-04950615 0.25 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266037|NCT01342211|O1|Outcome|Placebo|Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266038|NCT01342211|E5|Reported Event|PF-04950615 6.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266039|NCT01342211|E4|Reported Event|PF-04950615 3.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266040|NCT01342211|E3|Reported Event|PF-04950615 1.0 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266041|NCT01342211|E2|Reported Event|PF-04950615 0.25 mg/kg|Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266042|NCT01342211|E1|Reported Event|Placebo|Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
266043|NCT01342172|B1|Baseline|Lenalidomide|lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
266044|NCT01342172|P1|Participant Flow|Lenalidomide|lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
266045|NCT01342172|O1|Outcome|Lenalidomide|lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
266046|NCT01342172|E1|Reported Event|Lenalidomide|lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
266047|NCT01342107|B3|Baseline|Total|Total of all reporting groups
266048|NCT01342107|B2|Baseline|Blister Pack|Contact lens removed directly from the blister pack randomly assigned to right eye, with contact lens soaked overnight in an investigational multi-purpose disinfecting solution assigned to left eye for contralateral wear.
266049|NCT01342107|B1|Baseline|FID 114675A|Contact lens soaked overnight in an investigational multi-purpose disinfecting solution randomly assigned to right eye, with contact lens removed directly from the blister pack assigned to left eye for contralateral wear.
266050|NCT01342107|P2|Participant Flow|Blister Pack|Contact lens removed directly from the blister pack randomly assigned to right eye, with contact lens soaked overnight in an investigational multi-purpose disinfecting solution assigned to left eye for contralateral wear.
266051|NCT01342107|P1|Participant Flow|FID 114675A|Contact lens soaked overnight in an investigational multi-purpose disinfecting solution randomly assigned to right eye, with contact lens removed directly from the blister pack assigned to left eye for contralateral wear.
266052|NCT01342107|O2|Outcome|Blister Pack|Contact lens removed directly from the blister pack and inserted on day of dispense for 16 hours of wear.
266053|NCT01342107|O1|Outcome|FID 114675A|Contact lens soaked overnight in an investigational multi-purpose disinfecting solution and inserted on day of dispense for 16 hours of wear.
266054|NCT01342107|E2|Reported Event|Blister Pack|Contact lens removed directly from the blister pack and inserted on day of dispense for 16 hours of wear.
266055|NCT01342107|E1|Reported Event|FID 114675A|Contact lens soaked overnight in an investigational multi-purpose disinfecting solution and inserted on day of dispense for 16 hours of wear.
266056|NCT01342094|B3|Baseline|Total|Total of all reporting groups
266057|NCT01342094|B2|Baseline|Timolol|Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
266058|NCT01342094|B1|Baseline|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
266059|NCT01342094|P2|Participant Flow|Timolol|Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
266060|NCT01342094|P1|Participant Flow|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
266061|NCT01342094|O2|Outcome|Timolol|Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
266062|NCT01342094|O1|Outcome|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
266063|NCT01342094|E2|Reported Event|Timolol|Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
266066|NCT01342081|B3|Baseline|Tafluprost Plus Timolol|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes.
266067|NCT01342081|B2|Baseline|Tafluprost|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
266068|NCT01342081|B1|Baseline|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
266069|NCT01342081|P3|Participant Flow|Tafluprost Plus Timolol|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes.
266070|NCT01342081|P2|Participant Flow|Tafluprost|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
266071|NCT01342081|P1|Participant Flow|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
266072|NCT01342081|O3|Outcome|Tafluprost Plus Timolol|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes.
266073|NCT01342081|O2|Outcome|Tafluprost|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
266074|NCT01342081|O1|Outcome|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
266075|NCT01342081|E3|Reported Event|Tafluprost Plus Timolol|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes.
266076|NCT01342081|E2|Reported Event|Tafluprost|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
266077|NCT01342081|E1|Reported Event|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
266078|NCT01342029|B1|Baseline|Ranolazine/Placebo|"147 subjects will be enrolled at two clinical sites, with projected 9-10% dropout and anticipated 134 completed subjects.~For Ranolazine first group, subjects will undergo baseline testing and then be randomized into a clinical cross-over trial of stepped dosing of ranolazine or placebo 500-1,000 mg po bid for 2 weeks with exit testing followed by cross-over to the alternate ranolazine or placebo and repeat exit testing.~For Placebo first group, subjects will undergo baseline testing and then be randomized into a clinical cross-over trial of stepped dosing of ranolazine or placebo 500-1,000 mg po bid for 2 weeks with exit testing followed by cross-over to the alternate ranolazine or placebo and repeat exit testing."
266079|NCT01342029|P2|Participant Flow|Placebo First, Then Ranolazine|"147 subjects, with projected 9-10% dropout and anticipated 134 completed subjects will undergo baseline testing and then be randomized into a clinical cross-over trial of stepped dosing of ranolazine or placebo 500-1,000 mg po bid for 2 weeks with exit testing followed by cross-over to the alternate ranolazine or placebo and repeat exit testing.~Placebo: 500-1,000 mg po bid for 2 weeks"
266080|NCT01342029|P1|Participant Flow|Ranolazine First, Then Placebo|"147 subjects, with projected 9-10% dropout and anticipated 134 completed subjects will undergo baseline testing and then be randomized into a clinical cross-over trial of stepped dosing of ranolazine or placebo 500-1,000 mg po bid for 2 weeks with exit testing followed by cross-over to the alternate ranolazine or placebo and repeat exit testing.~Ranolazine: This drug is approved by the U.S. Food and Drug Administration (FDA) for treatment of chronic angina.~500-1,000 mg po bid for 2 weeks"
266081|NCT01342029|O2|Outcome|Placebo|147 subjects with projected 9-10% dropout
266082|NCT01342029|O1|Outcome|Ranolazine|147 subjects, with projected 9-10% dropout and anticipated 134 completed subjects will undergo basel...
266083|NCT01342029|O2|Outcome|Placebo|"147 subjects, with projected 9-10% dropout and anticipated 134 completed subjects will undergo baseline testing and then be randomized into a clinical cross-over trial of stepped dosing of ranolazine or placebo 500-1,000 mg po bid for 2 weeks with exit testing followed by cross-over to the alternate ranolazine or placebo and repeat exit testing.~Placebo: 500-1,000 mg po bid for 2 weeks"
266084|NCT01342029|O1|Outcome|Ranolazine|"147 subjects, with projected 9-10% dropout and anticipated 134 completed subjects will undergo baseline testing and then be randomized into a clinical cross-over trial of stepped dosing of ranolazine or placebo 500-1,000 mg po bid for 2 weeks with exit testing followed by cross-over to the alternate ranolazine or placebo and repeat exit testing.~Ranolazine: This drug is approved by the U.S. Food and Drug Administration (FDA) for treatment of chronic angina.~500-1,000 mg po bid for 2 weeks"
266085|NCT01342029|E2|Reported Event|Placebo|"147 subjects, with projected 9-10% dropout and anticipated 134 completed subjects will undergo baseline testing and then be randomized into a clinical cross-over trial of stepped dosing of ranolazine or placebo 500-1,000 mg po bid for 2 weeks with exit testing followed by cross-over to the alternate ranolazine or placebo and repeat exit testing.~Ranolazine: This drug is approved by the U.S. Food and Drug Administration (FDA) for treatment of chronic angina.~500-1,000 mg po bid for 2 weeks Placebo: 500-1,000 mg po bid for 2 weeks"
266086|NCT01342029|E1|Reported Event|Ranolazine|"147 subjects, with projected 9-10% dropout and anticipated 134 completed subjects will undergo baseline testing and then be randomized into a clinical cross-over trial of stepped dosing of ranolazine or placebo 500-1,000 mg po bid for 2 weeks with exit testing followed by cross-over to the alternate ranolazine or placebo and repeat exit testing.~Ranolazine: This drug is approved by the U.S. Food and Drug Administration (FDA) for treatment of chronic angina.~500-1,000 mg po bid for 2 weeks Placebo: 500-1,000 mg po bid for 2 weeks"
266087|NCT01341990|B3|Baseline|Total|Total of all reporting groups
266088|NCT01341990|B2|Baseline|ReNu MultiPlus|Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
266089|NCT01341990|B1|Baseline|FID 114675A|Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
266090|NCT01341990|P2|Participant Flow|ReNu MultiPlus|Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
266091|NCT01341990|P1|Participant Flow|FID 114675A|Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
266092|NCT01341990|O2|Outcome|ReNu MultiPlus|Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
266093|NCT01341990|O1|Outcome|FID 114675A|Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
266094|NCT01341990|O2|Outcome|ReNu MultiPlus|Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
266095|NCT01341990|O1|Outcome|FID 114675A|Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
266096|NCT01341990|E2|Reported Event|ReNu MultiPlus|Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
266097|NCT01341990|E1|Reported Event|FID 114675A|Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
266098|NCT01341977|B3|Baseline|Total|Total of all reporting groups
266099|NCT01341977|B2|Baseline|ReNu Fresh Multi-Purpose Solution|ReNu Fresh Multi-Purpose Solution (MPS)
266100|NCT01341977|B1|Baseline|Alcon MPDS|Alcon Multi-Purpose Disinfecting Solution (MPDS)
266101|NCT01341977|P2|Participant Flow|ReNu Fresh Multi-Purpose Solution|ReNu Fresh Multi-Purpose Solution (MPS)
266102|NCT01341977|P1|Participant Flow|Alcon MPDS|Alcon Multi-Purpose Disinfecting Solution (MPDS)
266103|NCT01341977|O2|Outcome|ReNu Fresh Multi-Purpose Solution|ReNu Fresh Multi-Purpose Solution (MPS)
266104|NCT01341977|O1|Outcome|Alcon MPDS|Alcon Multi-Purpose Disinfecting Solution (MPDS)
266105|NCT01341977|E2|Reported Event|ReNu Fresh Multi-Purpose Solution|ReNu Fresh Multi-Purpose Solution (MPS)
266106|NCT01341977|E1|Reported Event|Alcon MPDS|Alcon Multi-Purpose Disinfecting Solution (MPDS)
266107|NCT01341912|B1|Baseline|Human-cl rhFVIII|"Recombinant FVIII derived from a human cell line.~Human-cl rhFVIII : Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery."
266108|NCT01341912|P1|Participant Flow|Human-cl rhFVIII|"Recombinant FVIII derived from a human cell line.~Human-cl rhFVIII : Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery."
266109|NCT01341912|O1|Outcome|Human-cl rhFVIII|"Recombinant FVIII derived from a human cell line.~Human-cl rhFVIII : Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery."
266110|NCT01341912|O1|Outcome|Human-cl rhFVIII|"Recombinant FVIII derived from a human cell line.~Human-cl rhFVIII : Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery."
266111|NCT01341912|E1|Reported Event|Human-cl rhFVIII|"Recombinant FVIII derived from a human cell line.~Human-cl rhFVIII : Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery."
266112|NCT01341782|B3|Baseline|Total|Total of all reporting groups
266113|NCT01341782|B2|Baseline|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
266114|NCT01341782|B1|Baseline|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
266115|NCT01341782|P2|Participant Flow|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (intact parathyroid hormone [iPTH] < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
266116|NCT01341782|P1|Participant Flow|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
266117|NCT01341782|O2|Outcome|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
266118|NCT01341782|O1|Outcome|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
266119|NCT01341782|O2|Outcome|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
266120|NCT01341782|O1|Outcome|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
266121|NCT01341782|O2|Outcome|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
266122|NCT01341782|O1|Outcome|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
266123|NCT01341782|O2|Outcome|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
266124|NCT01341782|O1|Outcome|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
266125|NCT01341782|O2|Outcome|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
266126|NCT01341782|O1|Outcome|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
266127|NCT01341782|O2|Outcome|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
266128|NCT01341782|O1|Outcome|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
266129|NCT01341782|E2|Reported Event|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
266130|NCT01341782|E1|Reported Event|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
266131|NCT01341600|B4|Baseline|Total|Total of all reporting groups
266132|NCT01341600|B3|Baseline|Extensive Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 extensive metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
266133|NCT01341600|B2|Baseline|Intermediate Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 intermediate metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
266134|NCT01341600|B1|Baseline|Poor Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 poor metabolizers to clopidogrel 75 mg from participants who previously received clopidogrel as part of another NIH sponsored clinical trial entitled, Pharmacogenetics of Anti-platelet Intervention (PAPI) Study (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
266135|NCT01341600|P3|Participant Flow|Extensive Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI (NCT00799396)) will be recruited. We will select 6 extensive metabolizers to clopidogrel 75 mg in PAPI (NCT00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
266136|NCT01341600|P2|Participant Flow|Intermediate Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI (NCT00799396)) will be recruited. We will select 6 intermediate metabolizers to clopidogrel 75 mg in PAPI (NCT00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
266147|NCT01341600|O3|Outcome|Extensive Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 extensive metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
266137|NCT01341600|P1|Participant Flow|Poor Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI (NCT00799396)) will be recruited. We will select 6 poor metabolizers to clopidogrel 75 mg from participants who previously received clopidogrel as part of another NIH sponsored clinical trial entitled, Pharmacogenetics of Anti-platelet Intervention (PAPI) Study (NCT00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
266138|NCT01341600|O3|Outcome|Extensive Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 extensive metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
266139|NCT01341600|O2|Outcome|Intermediate Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 intermediate metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
266140|NCT01341600|O1|Outcome|Poor Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 poor metabolizers to clopidogrel 75 mg from participants who previously received clopidogrel as part of another NIH sponsored clinical trial entitled, Pharmacogenetics of Anti-platelet Intervention (PAPI) Study (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
266141|NCT01341600|O3|Outcome|Extensive Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 extensive metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
266142|NCT01341600|O2|Outcome|Intermediate Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 intermediate metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
266143|NCT01341600|O1|Outcome|Poor Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 poor metabolizers to clopidogrel 75 mg from participants who previously received clopidogrel as part of another NIH sponsored clinical trial entitled, Pharmacogenetics of Anti-platelet Intervention (PAPI) Study (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
266144|NCT01341600|O3|Outcome|Extensive Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 extensive metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
266145|NCT01341600|O2|Outcome|Intermediate Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 intermediate metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
266146|NCT01341600|O1|Outcome|Poor Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 poor metabolizers to clopidogrel 75 mg from participants who previously received clopidogrel as part of another NIH sponsored clinical trial entitled, Pharmacogenetics of Anti-platelet Intervention (PAPI) Study (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
266169|NCT01341444|E2|Reported Event|Standard of Care for Surgical Incisions|"Sterile gauze and a non-penetrable barrier~Standard of Care for Surgical Incisions: Sterile 4X4 Non-Penetrable barrier"
266520|NCT01340573|E1|Reported Event|All Participants|Genotype 1 CHC Participants and Non-genotype 1 CHC partipants
289214|NCT01275053|O1|Outcome|Leptin|leptin: 0.01mg/kg
266148|NCT01341600|O2|Outcome|Intermediate Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 intermediate metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
266149|NCT01341600|O1|Outcome|Poor Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 poor metabolizers to clopidogrel 75 mg from participants who previously received clopidogrel as part of another NIH sponsored clinical trial entitled, Pharmacogenetics of Anti-platelet Intervention (PAPI) Study (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
266150|NCT01341600|E3|Reported Event|Extensive Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 extensive metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
266151|NCT01341600|E2|Reported Event|Intermediate Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 intermediate metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
266152|NCT01341600|E1|Reported Event|Poor Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 poor metabolizers to clopidogrel 75 mg from participants who previously received clopidogrel as part of another NIH sponsored clinical trial entitled, Pharmacogenetics of Anti-platelet Intervention (PAPI) Study (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
266153|NCT01341587|B3|Baseline|Total|Total of all reporting groups
266154|NCT01341587|B2|Baseline|Intervention|"Home diabetes monitoring by patient using cellular enabled glucometer to communicate information and receive feedback.~Care provider can access raw and analyzed patient data; Physician receives report summary.~Telcare Blood Glucose Meter (BGM): Cellular enabled glucometer"
266155|NCT01341587|B1|Baseline|Control|Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
266156|NCT01341587|P2|Participant Flow|Intervention|"Home diabetes monitoring by patient using cellular enabled glucometer to communicate information and receive feedback.~Care provider can access raw and analyzed patient data; Physician receives report summary.~Telcare Blood Glucose Meter (BGM): Cellular enabled glucometer"
266157|NCT01341587|P1|Participant Flow|Control|Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
266158|NCT01341587|O2|Outcome|Intervention|"Home diabetes monitoring by patient using cellular enabled glucometer to communicate information and receive feedback.~Care provider can access raw and analyzed patient data; Physician receives report summary.~Telcare Blood Glucose Meter (BGM): Cellular enabled glucometer"
266159|NCT01341587|O1|Outcome|Control|Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
266160|NCT01341587|E2|Reported Event|Intervention|"Home diabetes monitoring by patient using cellular enabled glucometer to communicate information and receive feedback.~Care provider can access raw and analyzed patient data; Physician receives report summary.~Telcare Blood Glucose Meter (BGM): Cellular enabled glucometer"
266161|NCT01341587|E1|Reported Event|Control|Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
266162|NCT01341444|B3|Baseline|Total|Total of all reporting groups
266163|NCT01341444|B2|Baseline|Standard of Care for Surgical Incisions|"Sterile gauze and a non-penetrable barrier~Standard of Care for Surgical Incisions: Sterile 4X4 Non-Penetrable barrier"
266164|NCT01341444|B1|Baseline|Prevena Incision Management System|"Negative Pressure Therapy Device~Prevena Incision Management System: It is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy (NPWT)."
266165|NCT01341444|P2|Participant Flow|Standard of Care for Surgical Incisions|"Sterile gauze and a non-penetrable barrier~Standard of Care for Surgical Incisions: Sterile 4X4 Non-Penetrable barrier"
266166|NCT01341444|P1|Participant Flow|Prevena Incision Management System|"Negative Pressure Therapy Device~Prevena Incision Management System: It is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy (NPWT)."
266167|NCT01341444|O2|Outcome|Standard of Care for Surgical Incisions|"Sterile gauze and a non-penetrable barrier~Standard of Care for Surgical Incisions: Sterile 4X4 Non-Penetrable barrier"
266168|NCT01341444|O1|Outcome|Prevena Incision Management System|"Negative Pressure Therapy Device~Prevena Incision Management System: It is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy (NPWT)."
266170|NCT01341444|E1|Reported Event|Prevena Incision Management System|"Negative Pressure Therapy Device~Prevena Incision Management System: It is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy (NPWT)."
266171|NCT01341301|B1|Baseline|Allogeneic HSCT|"CONDITIONING: Patients undergo TBI BID on days -10 to -7. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients receive DLI on day -6 and undergo CD34+ selected allogeneic HSCT on day 0~GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO on days -1 with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID or PO on days -1 to 28.~Total Body Irradiation: Undergo TBI~Donor Lymphocyte Infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Tacrolimus: Given IV or PO~Mycophenolate mofetil: Given IV or PO~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~Laboratory biomarker analysis: Correlative studies"
266172|NCT01341301|P1|Participant Flow|Allogeneic HSCT|"CONDITIONING: Patients undergo total body irradiation (TBI) twice daily (BID) on days -10 to -7. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients receive Donor Lymphocyte Infusion (DLI) on day -6 and undergo cluster of differentiation (CD34+) selected allogeneic HSCT on day 0~Graft-versus-host disease (GVHD) PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO on days -1 with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID or PO on days -1 to 28.~Total Body Irradiation: Undergo TBI~Donor Lymphocyte Infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Tacrolimus: Given IV or PO~Mycophenolate mofetil: Given IV or PO~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~Laboratory biomarker analysis: Correlative studies"
266173|NCT01341301|O1|Outcome|Allogeneic HSCT|"CONDITIONING: Patients undergo total body irradiation (TBI) twice daily (BID) on days -10 to -7. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients receive DLI on day -6 and undergo cluster of differentiation (CD34+) selected allogeneic HSCT on day 0~Graft-versus-host disease (GVHD) PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO on days -1 with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID or PO on days -1 to 28.~Total Body Irradiation: Undergo TBI~Donor Lymphocyte Infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Tacrolimus: Given IV or PO~Mycophenolate mofetil: Given IV or PO~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~Laboratory biomarker analysis: Correlative studies"
266174|NCT01341301|O1|Outcome|Allogeneic HSCT|"CONDITIONING: Patients undergo Total Body Irradiation (TBI) twice daily (BID) on days -10 to -7. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients receive DLI on day -6 and undergo cluster of differentiation 34 (CD34+) selected allogeneic HSCT on day 0~GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO on days -1 with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID or PO on days -1 to 28.~Total Body Irradiation: Undergo TBI~Donor Lymphocyte Infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Tacrolimus: Given IV or PO~Mycophenolate mofetil: Given IV or PO~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~Laboratory biomarker analysis: Correlative studies"
266175|NCT01341301|O1|Outcome|Allogeneic HSCT|"CONDITIONING: Patients undergo TBI BID on days -10 to -7. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients receive DLI on day -6 and undergo CD34+ selected allogeneic HSCT on day 0~GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO on days -1 with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID or PO on days -1 to 28.~Total Body Irradiation: Undergo TBI~Donor Lymphocyte Infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Tacrolimus: Given IV or PO~Mycophenolate mofetil: Given IV or PO~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~Laboratory biomarker analysis: Correlative studies"
266176|NCT01341301|O1|Outcome|Allogeneic HSCT|"CONDITIONING: Patients undergo TBI BID on days -10 to -7. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients receive DLI on day -6 and undergo CD34+ selected allogeneic HSCT on day 0~GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO on days -1 with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID or PO on days -1 to 28.~Total Body Irradiation: Undergo TBI~Donor Lymphocyte Infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Tacrolimus: Given IV or PO~Mycophenolate mofetil: Given IV or PO~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~Laboratory biomarker analysis: Correlative studies"
266177|NCT01341301|E1|Reported Event|Allogeneic HSCT|"CONDITIONING: Patients undergo TBI BID on days -10 to -7. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients receive DLI on day -6 and undergo CD34+ selected allogeneic HSCT on day 0~GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO on days -1 with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID or PO on days -1 to 28.~Total Body Irradiation: Undergo TBI~Donor Lymphocyte Infusion (DLI): Undergo DLI~Cyclophosphamide: Given IV~Tacrolimus: Given IV or PO~Mycophenolate mofetil: Given IV or PO~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~Laboratory biomarker analysis: Correlative studies"
266178|NCT01341067|B1|Baseline|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
266179|NCT01341067|P1|Participant Flow|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
266180|NCT01341067|O1|Outcome|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
266181|NCT01341067|O1|Outcome|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
266182|NCT01341067|O1|Outcome|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
266183|NCT01341067|O1|Outcome|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
266184|NCT01341067|E1|Reported Event|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
266185|NCT01340937|B5|Baseline|Total|Total of all reporting groups
266186|NCT01340937|B4|Baseline|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266187|NCT01340937|B3|Baseline|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266188|NCT01340937|B2|Baseline|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266189|NCT01340937|B1|Baseline|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266190|NCT01340937|P4|Participant Flow|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266191|NCT01340937|P3|Participant Flow|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266192|NCT01340937|P2|Participant Flow|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266193|NCT01340937|P1|Participant Flow|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266194|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266195|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266196|NCT01340937|O2|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266197|NCT01340937|O1|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266198|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266199|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266200|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266201|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266202|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266203|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266204|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266205|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266206|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266207|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266208|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266209|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266210|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266211|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266212|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266609|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
266213|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266214|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266215|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266216|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266217|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266218|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266219|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266220|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266221|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266222|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266223|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266224|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266225|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266226|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266227|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266228|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266229|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266230|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266231|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266232|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266233|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266234|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266235|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266236|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266237|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266658|NCT01340027|B8|Baseline|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266238|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266239|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266240|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266241|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266242|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266243|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266244|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266245|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266246|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266247|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266248|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266249|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266250|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266251|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266252|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266253|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266254|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266255|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266256|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266257|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266258|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266259|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266260|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266261|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266262|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266659|NCT01340027|B7|Baseline|Solifenacin 2.5 mg +Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266263|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266264|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266265|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266266|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266267|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266268|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266269|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266270|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266271|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266272|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266273|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266274|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266275|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266276|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266277|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266278|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266279|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266280|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266281|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266282|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266283|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266284|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266285|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266286|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266287|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266660|NCT01340027|B6|Baseline|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266288|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266289|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266290|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266291|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266292|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266293|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266294|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266295|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266296|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266297|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266298|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266299|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266300|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266301|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266302|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266303|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266304|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266305|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266306|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266307|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266308|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266309|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266310|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266311|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266312|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266367|NCT01340768|B2|Baseline|Sulfonylurea Therapy|Usual sulfonylurea therapy and dose for each participant, with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.
266313|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266314|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266315|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266316|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266317|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266318|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266319|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266320|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266321|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266322|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266323|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266324|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266325|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266326|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266327|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266328|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266329|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266330|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266331|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266332|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266333|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266334|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266335|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266336|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266337|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266507|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
266508|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
266509|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
266338|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266339|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266340|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266341|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266342|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266343|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266344|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266345|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266346|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266347|NCT01340937|E2|Reported Event|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
266348|NCT01340937|E1|Reported Event|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
266349|NCT01340794|B3|Baseline|Total|Total of all reporting groups
266350|NCT01340794|B2|Baseline|Treatment: Pazopanib With Run-in|"Cycle 1:~Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 2:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 3 and beyond:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
266351|NCT01340794|B1|Baseline|Treatment: Pazopanib Without Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
266352|NCT01340794|P2|Participant Flow|Treatment: Pazopanib Run-in|"Cycle 1:~Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 2:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 3 and beyond:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
266353|NCT01340794|P1|Participant Flow|Treatment: Pazopanib With no Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
266354|NCT01340794|O2|Outcome|Treatment: Pazopanib Run-in|"Cycle 1:~Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 2:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 3 and beyond:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
266355|NCT01340794|O1|Outcome|Treatment: Pazopanib With no Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
266356|NCT01340794|O2|Outcome|Treatment: Pazopanib Run-in|"Cycle 1:~Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 2:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 3 and beyond:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
266357|NCT01340794|O1|Outcome|Treatment: Pazopanib With no Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
266358|NCT01340794|O2|Outcome|Treatment: Pazopanib With Run-in|"Cycle 1:~Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 2:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 3 and beyond:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
266359|NCT01340794|O1|Outcome|Treatment: Pazopanib Without Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
266360|NCT01340794|O2|Outcome|Treatment: Pazopanib With Run-in|"Cycle 1:~Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 2:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 3 and beyond:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
266361|NCT01340794|O1|Outcome|Treatment: Pazopanib Without Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
266362|NCT01340794|O2|Outcome|Treatment: Pazopanib Run-in|"Cycle 1:~Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 2:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 3 and beyond:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
266363|NCT01340794|O1|Outcome|Treatment: Pazopanib With no Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
266364|NCT01340794|E2|Reported Event|Treatment: Pazopanib With Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
266365|NCT01340794|E1|Reported Event|Treatment: Pazopanib Without Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
266366|NCT01340768|B3|Baseline|Total|Total of all reporting groups
266510|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
266368|NCT01340768|B1|Baseline|Sitagliptin|Sitagliptin 100mg taken orally once daily with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.
266369|NCT01340768|P2|Participant Flow|Sulfonylurea Therapy|Usual sulfonylurea therapy and dose for each participant, with or without metformin
266370|NCT01340768|P1|Participant Flow|Sitagliptin|Sitagliptin 100mg taken orally once daily, with or without metformin
266371|NCT01340768|O2|Outcome|Sulfonylurea Therapy|Usual sulfonylurea therapy and dose for each participant, with or without metformin
266372|NCT01340768|O1|Outcome|Sitagliptin|Sitagliptin 100mg taken orally once daily, with or without metformin
266373|NCT01340768|O2|Outcome|Sulfonylurea Therapy|Usual sulfonylurea therapy and dose for each participant, with or without metformin
266374|NCT01340768|O1|Outcome|Sitagliptin|Sitagliptin 100mg taken orally once daily, with or without metformin
266375|NCT01340768|E2|Reported Event|Sulfonylurea Therapy|Usual sulfonylurea therapy and dose for each participant, with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.
266376|NCT01340768|E1|Reported Event|Sitagliptin|Sitagliptin 100mg taken orally once daily with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.
266377|NCT01340664|B4|Baseline|Total|Total of all reporting groups
266378|NCT01340664|B3|Baseline|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks.
266379|NCT01340664|B2|Baseline|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks.
266380|NCT01340664|B1|Baseline|Placebo|Each patient received matching placebo twice daily for 18 weeks.
266381|NCT01340664|P3|Participant Flow|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks.
266382|NCT01340664|P2|Participant Flow|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks.
266383|NCT01340664|P1|Participant Flow|Placebo|Each patient received matching placebo twice daily for 18 weeks.
266384|NCT01340664|O3|Outcome|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks
266385|NCT01340664|O2|Outcome|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks
266386|NCT01340664|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 18 weeks.
266387|NCT01340664|O3|Outcome|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks
266388|NCT01340664|O2|Outcome|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks
266389|NCT01340664|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 18 weeks.
266390|NCT01340664|O3|Outcome|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks
266391|NCT01340664|O2|Outcome|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks
266392|NCT01340664|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 18 weeks.
266393|NCT01340664|O3|Outcome|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks
266394|NCT01340664|O2|Outcome|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks
266395|NCT01340664|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 18 weeks.
266396|NCT01340664|E3|Reported Event|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks
266397|NCT01340664|E2|Reported Event|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks.
266398|NCT01340664|E1|Reported Event|Placebo|Each patient received matching placebo twice daily for 18 weeks
266399|NCT01340651|B1|Baseline|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
266400|NCT01340651|P1|Participant Flow|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD. At Week 16, participants transitioned to ruxolitinib 10, 15, or 20 mg immediate release (IR) orally twice daily up to when the last participant completed Week 36 or the commercial availability of ruxolitinib IR, whichever was earlier; the dose received was based on platelet counts at the time of transition.
266401|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD).
266402|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD).
266403|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD).
266404|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
266405|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
266406|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
266407|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
266408|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
266511|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
266409|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
266410|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
266411|NCT01340651|E2|Reported Event|Ruxolitinib - After Week 16|At Week 16, participants transitioned to ruxolitinib 10, 15, or 20 mg immediate release (IR) orally twice daily up to when the last participant completed Week 36 or the commercial availability of ruxolitinib IR, whichever was earlier; the dose received was based on platelet counts at the time of transition.
266412|NCT01340651|E1|Reported Event|Ruxolitinib - Weeks 1-16|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
266413|NCT01340625|B3|Baseline|Total|Total of all reporting groups
266414|NCT01340625|B2|Baseline|Ovcon® 35 Fe (Reference) First|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in first period followed by 0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
266415|NCT01340625|B1|Baseline|Norethindrone/Ethinyl Estradiol (Test) First|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in first period followed by 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in the second period.
266416|NCT01340625|P2|Participant Flow|Ovcon® 35 Fe (Reference) First|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in first period followed by 0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
266417|NCT01340625|P1|Participant Flow|Norethindrone/Ethinyl Estradiol (Test) First|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in first period followed by 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in the second period.
266418|NCT01340625|O2|Outcome|Ovcon® 35 Fe (Reference)|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
266419|NCT01340625|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
266420|NCT01340625|O2|Outcome|Ovcon® 35 Fe (Reference)|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
266421|NCT01340625|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
266422|NCT01340625|O2|Outcome|Ovcon® 35 Fe (Reference)|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
266423|NCT01340625|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
266424|NCT01340625|O2|Outcome|Ovcon® 35 Fe (Reference)|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
266425|NCT01340625|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
266426|NCT01340625|O2|Outcome|Ovcon® 35 Fe (Reference)|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
266427|NCT01340625|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
266428|NCT01340625|O2|Outcome|Ovcon® 35 Fe (Reference)|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
266429|NCT01340625|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
266430|NCT01340625|E2|Reported Event|Ovcon® 35 Fe (Reference) First|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in first period followed by 0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
266431|NCT01340625|E1|Reported Event|Norethindrone/Ethinyl Estradiol (Test) First|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in first period followed by 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in the second period.
266432|NCT01340586|B3|Baseline|Total|Total of all reporting groups
266433|NCT01340586|B2|Baseline|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
266434|NCT01340586|B1|Baseline|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
266435|NCT01340586|P2|Participant Flow|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
266436|NCT01340586|P1|Participant Flow|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
266437|NCT01340586|O2|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
266438|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
266512|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
266513|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
266514|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
266515|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
266439|NCT01340586|O2|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
266440|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
266441|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
266442|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
266443|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
266444|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
266445|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
266446|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
266447|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
266448|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
266449|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
266450|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
266451|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
266452|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
266453|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
266454|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
266455|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
266456|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
266457|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
266458|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis.
266459|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
266460|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
266461|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis.
266462|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
266463|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
266464|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
266465|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis.
266466|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
266467|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
266516|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
266517|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
266468|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
266469|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
266470|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
266471|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
266472|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
266473|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
266474|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
266475|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
266476|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
266477|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
266478|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
266479|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
266480|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis.
266481|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
266482|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
266483|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
266484|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
266485|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
266486|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
266487|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
266488|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
266489|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis.
266490|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
266491|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
266492|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
266493|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
266494|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
266495|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis.
266496|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
266497|NCT01340586|E3|Reported Event|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
266498|NCT01340586|E2|Reported Event|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
266499|NCT01340586|E1|Reported Event|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
266500|NCT01340573|B1|Baseline|All Participants|Genotype 1 CHC Participants and Non-genotype 1 CHC partipants
266501|NCT01340573|P1|Participant Flow|All Participants|Genotype 1 CHC Participants and Non-genotype 1 CHC partipants
266502|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
266503|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
266504|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
266505|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
266506|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
266521|NCT01340495|B1|Baseline|Proton Radiation|"Radiation therapy with proton beam~Proton Radiation: 45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks"
266522|NCT01340495|P1|Participant Flow|Proton Radiation|"Radiation therapy with proton beam~Proton Radiation: 45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks"
266523|NCT01340495|O1|Outcome|Proton Radiation|"Radiation therapy with proton beam~Proton Radiation: 45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks"
266524|NCT01340495|O1|Outcome|Proton Radiation|"Radiation therapy with proton beam~Proton Radiation: 45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks"
266525|NCT01340495|O1|Outcome|Proton Radiation|"Radiation therapy with proton beam~Proton Radiation: 45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks"
266526|NCT01340495|E1|Reported Event|Proton Radiation|"Radiation therapy with proton beam~Proton Radiation: 45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks"
266527|NCT01340300|B5|Baseline|Total|Total of all reporting groups
266528|NCT01340300|B4|Baseline|Control|"Educational information~Educational information: educational information"
266529|NCT01340300|B3|Baseline|Metformin|"Metformin~Metformin: Oral metformin QD for two weeks, then BID"
266530|NCT01340300|B2|Baseline|Exercise Training|"Exercise training with exercise physiologist~Exercise training: Two supervised exercise sessions per week"
266531|NCT01340300|B1|Baseline|Exercise Training With Metformin|"Exercise training with exercise physiologist with oral metformin~Exercise training plus metformin: Two supervised exercise sessions per week. Oral metformin QD for 2 weeks, then BID"
266532|NCT01340300|P4|Participant Flow|Control|"Educational information~Educational information: educational information"
266533|NCT01340300|P3|Participant Flow|Metformin|"Metformin~Metformin: Oral metformin QD for two weeks, then BID"
266534|NCT01340300|P2|Participant Flow|Exercise Training|"Exercise training with exercise physiologist~Exercise training: Two supervised exercise sessions per week"
266535|NCT01340300|P1|Participant Flow|Exercise Training With Metformin|"Exercise training with exercise physiologist with oral metformin~Exercise training plus metformin: Two supervised exercise sessions per week. Oral metformin QD for 2 weeks, then BID"
266536|NCT01340300|O4|Outcome|Control|"Educational information~Educational information: educational information"
266537|NCT01340300|O3|Outcome|Metformin|"Metformin~Metformin: Oral metformin QD for two weeks, then BID"
266538|NCT01340300|O2|Outcome|Exercise Training|"Exercise training with exercise physiologist~Exercise training: Two supervised exercise sessions per week"
266539|NCT01340300|O1|Outcome|Exercise Training With Metformin|"Exercise training with exercise physiologist with oral metformin~Exercise training plus metformin: Two supervised exercise sessions per week. Oral metformin QD for 2 weeks, then BID"
266540|NCT01340300|O4|Outcome|Control|"Educational information~Educational information: educational information"
266541|NCT01340300|O3|Outcome|Metformin|"Metformin~Metformin: Oral metformin QD for two weeks, then BID"
266542|NCT01340300|O2|Outcome|Exercise Training|"Exercise training with exercise physiologist~Exercise training: Two supervised exercise sessions per week"
266543|NCT01340300|O1|Outcome|Exercise Training With Metformin|"Exercise training with exercise physiologist with oral metformin~Exercise training plus metformin: Two supervised exercise sessions per week. Oral metformin QD for 2 weeks, then BID"
266544|NCT01340300|O4|Outcome|Control|"Educational information~Educational information: educational information"
266545|NCT01340300|O3|Outcome|Metformin|"Metformin~Metformin: Oral metformin QD for two weeks, then BID"
266546|NCT01340300|O2|Outcome|Exercise Training|"Exercise training with exercise physiologist~Exercise training: Two supervised exercise sessions per week"
266547|NCT01340300|O1|Outcome|Exercise Training With Metformin|"Exercise training with exercise physiologist with oral metformin~Exercise training plus metformin: Two supervised exercise sessions per week. Oral metformin QD for 2 weeks, then BID"
266548|NCT01340300|O4|Outcome|Control|"Educational information~Educational information: educational information"
266549|NCT01340300|O3|Outcome|Metformin|"Metformin~Metformin: Oral metformin QD for two weeks, then BID"
266550|NCT01340300|O2|Outcome|Exercise Training|"Exercise training with exercise physiologist~Exercise training: Two supervised exercise sessions per week"
266551|NCT01340300|O1|Outcome|Exercise Training With Metformin|"Exercise training with exercise physiologist with oral metformin~Exercise training plus metformin: Two supervised exercise sessions per week. Oral metformin QD for 2 weeks, then BID"
266552|NCT01340300|O4|Outcome|Control|"Educational information~Educational information: educational information"
266553|NCT01340300|O3|Outcome|Metformin|"Metformin~Metformin: Oral metformin QD for two weeks, then BID"
266554|NCT01340300|O2|Outcome|Exercise Training|"Exercise training with exercise physiologist~Exercise training: Two supervised exercise sessions per week"
266555|NCT01340300|O1|Outcome|Exercise Training With Metformin|"Exercise training with exercise physiologist with oral metformin~Exercise training plus metformin: Two supervised exercise sessions per week. Oral metformin QD for 2 weeks, then BID"
266556|NCT01340300|O4|Outcome|Control|"Educational information~Educational information: educational information"
266557|NCT01340300|O3|Outcome|Metformin|"Metformin~Metformin: Oral metformin QD for two weeks, then BID"
266558|NCT01340300|O2|Outcome|Exercise Training|"Exercise training with exercise physiologist~Exercise training: Two supervised exercise sessions per week"
266559|NCT01340300|O1|Outcome|Exercise Training With Metformin|"Exercise training with exercise physiologist with oral metformin~Exercise training plus metformin: Two supervised exercise sessions per week. Oral metformin QD for 2 weeks, then BID"
266560|NCT01340300|E4|Reported Event|Control|"Educational information~Educational information: educational information"
266561|NCT01340300|E3|Reported Event|Metformin|"Metformin~Metformin: Oral metformin QD for two weeks, then BID"
266562|NCT01340300|E2|Reported Event|Exercise Training|"Exercise training with exercise physiologist~Exercise training: Two supervised exercise sessions per week"
266661|NCT01340027|B5|Baseline|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266563|NCT01340300|E1|Reported Event|Exercise Training With Metformin|"Exercise training with exercise physiologist with oral metformin~Exercise training plus metformin: Two supervised exercise sessions per week. Oral metformin QD for 2 weeks, then BID"
266564|NCT01340209|B4|Baseline|Total|Total of all reporting groups
266565|NCT01340209|B3|Baseline|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
266566|NCT01340209|B2|Baseline|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
266567|NCT01340209|B1|Baseline|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
266568|NCT01340209|P3|Participant Flow|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
266569|NCT01340209|P2|Participant Flow|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
266570|NCT01340209|P1|Participant Flow|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
266571|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
266572|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
266573|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
266574|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
266575|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
266576|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
266577|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
266578|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
266579|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
266580|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
266581|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
266582|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
266583|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
266584|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
266585|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
266586|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
266587|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
266588|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
266589|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
266590|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
266591|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
266592|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
266593|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
266594|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
266595|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
266596|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
266597|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
266598|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
266599|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
266600|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
266601|NCT01340209|E3|Reported Event|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
266602|NCT01340209|E2|Reported Event|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
266603|NCT01340209|E1|Reported Event|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
266604|NCT01340196|B1|Baseline|All Participants|tenofovir medium dose (300mg) once daily (qd, oral) for first 15 days; Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (300mg) twice daily (bid) on days 9 through day 22 (morning dose on day 22 only)
266605|NCT01340196|P1|Participant Flow|All Participants|tenofovir medium dose (300mg) once daily (qd, oral) for first 15 days; Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (300mg) twice daily (bid) on days 9 through day 22 (morning dose on day 22 only)
266606|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
266607|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
266608|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
289215|NCT01275053|E1|Reported Event|Leptin|leptin: 0.01mg/kg
266610|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
266611|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
266612|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
266613|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
266614|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
266615|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
266616|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
266617|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
266618|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
266619|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
266620|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
266621|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
266622|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
266623|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7
266624|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
266625|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
266626|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7
266627|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
266628|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
266629|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
266630|NCT01340196|E3|Reported Event|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
266631|NCT01340196|E2|Reported Event|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
266632|NCT01340196|E1|Reported Event|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
266633|NCT01340144|B3|Baseline|Total|Total of all reporting groups
266634|NCT01340144|B2|Baseline|PFC Sigma HP PS TKA (Total Knee Arthoplasty)|One group received primary TKA using the PFC Sigma HP PS TKA.
266635|NCT01340144|B1|Baseline|PFC Sigma PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma PS TKA
266636|NCT01340144|P2|Participant Flow|PFC Sigma HP PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma HP PS TKA.
266637|NCT01340144|P1|Participant Flow|PFC Sigma PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma PS TKA
266638|NCT01340144|O2|Outcome|PFC Sigma HP PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma HP PS TKA.
266639|NCT01340144|O1|Outcome|PFC Sigma PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma PS TKA
266640|NCT01340144|E2|Reported Event|PFC Sigma HP PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma HP PS TKA.
266641|NCT01340144|E1|Reported Event|PFC Sigma PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma PS TKA
266642|NCT01340066|B3|Baseline|Total|Total of all reporting groups
266643|NCT01340066|B2|Baseline|UISH001|At randomization at visit 2, subjects were treated with UISH001.
266644|NCT01340066|B1|Baseline|Matching Placebo|At randomization at visit 2, subjects were treated with matching placebo.
266645|NCT01340066|P3|Participant Flow|UISH001|Subjects were randomized at Visit 2
266646|NCT01340066|P2|Participant Flow|Placebo|Subjects were randomized at Visit 2
266647|NCT01340066|P1|Participant Flow|Placebo Run-In|All subjects entered a one week placebo run in period to qualify for the study.
266648|NCT01340066|O2|Outcome|UISH001|1 drop UISH001 sublingual 3 times/day
266649|NCT01340066|O1|Outcome|Placebo|1 drop Placebo sublingual 3 times/day
266650|NCT01340066|E3|Reported Event|Matching Placebo|Subjects were treated with matching placebo during double blind treatment period.
266651|NCT01340066|E2|Reported Event|UISH001|Subjects were treated with UISH001 during double blind treatment period.
266652|NCT01340066|E1|Reported Event|Non-Randomized Subjects|Adverse Events (AEs) captured for subjects that were not randomized
266653|NCT01340027|B13|Baseline|Total|Total of all reporting groups
266654|NCT01340027|B12|Baseline|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266655|NCT01340027|B11|Baseline|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266656|NCT01340027|B10|Baseline|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266657|NCT01340027|B9|Baseline|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266662|NCT01340027|B4|Baseline|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266663|NCT01340027|B3|Baseline|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266664|NCT01340027|B2|Baseline|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266665|NCT01340027|B1|Baseline|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266666|NCT01340027|P12|Participant Flow|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266667|NCT01340027|P11|Participant Flow|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266668|NCT01340027|P10|Participant Flow|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266669|NCT01340027|P9|Participant Flow|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266670|NCT01340027|P8|Participant Flow|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266671|NCT01340027|P7|Participant Flow|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266672|NCT01340027|P6|Participant Flow|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266673|NCT01340027|P5|Participant Flow|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266674|NCT01340027|P4|Participant Flow|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266675|NCT01340027|P3|Participant Flow|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266676|NCT01340027|P2|Participant Flow|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266677|NCT01340027|P1|Participant Flow|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266678|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266679|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266680|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266681|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266682|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266683|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266684|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266685|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266686|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266687|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266688|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266689|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266690|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266691|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266692|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266693|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266694|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266695|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266696|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266697|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266698|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266699|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266700|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266701|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266702|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266703|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266704|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266705|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266706|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266845|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266707|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266708|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266709|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266710|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266711|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266712|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266713|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266714|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266715|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266716|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266717|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266718|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266719|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266720|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266721|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266722|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266723|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266724|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266725|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266726|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266727|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266728|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266729|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266730|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266731|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266732|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266733|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266734|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266735|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266736|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266737|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266738|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266739|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266740|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266741|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266742|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266743|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266744|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266745|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266746|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266747|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266748|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266749|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266750|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266751|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266752|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
268229|NCT01335867|O1|Outcome|Vigabatrin|Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks
266753|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266754|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266755|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266756|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266757|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266758|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266759|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266760|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266761|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266762|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266763|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266764|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266765|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266766|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266767|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266768|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266769|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266770|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266771|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266772|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266773|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266774|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266775|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266776|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266777|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266778|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266779|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266780|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266781|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266782|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266783|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266784|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266785|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266786|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266787|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266788|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266789|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266790|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266791|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266792|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266793|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266794|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266795|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266796|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266797|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266798|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
268230|NCT01335867|E2|Reported Event|Placebo|Placebo: Placebo pills
266799|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266800|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266801|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266802|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266803|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266804|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266805|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266806|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266807|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266808|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266809|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266810|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266811|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266812|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266813|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266814|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266815|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266816|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266817|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266818|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266819|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266820|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266821|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266822|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266823|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266824|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266825|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266826|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266827|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266828|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266829|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266830|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266831|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266832|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266833|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266834|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266835|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266836|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266837|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266838|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266839|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266840|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266841|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266842|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266843|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266844|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266846|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266847|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266848|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266849|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266850|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266851|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266852|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266853|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266854|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266855|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266856|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266857|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266858|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266859|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266860|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266861|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266862|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266863|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266864|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266865|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266866|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266867|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266868|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266869|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266870|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266871|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266872|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266873|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266874|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266875|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266876|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266877|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266878|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266879|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266880|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266881|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266882|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266883|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266884|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266885|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266886|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266887|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266888|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266889|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266890|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266891|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266892|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266893|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266894|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266895|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266896|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266897|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266898|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266899|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266900|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266901|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266902|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266903|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266904|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266905|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266906|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266907|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266908|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266909|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266910|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266911|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266912|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266913|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266914|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266915|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266916|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266917|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266918|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266919|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266920|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266921|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266922|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266923|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266924|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266925|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266926|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266927|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266928|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266929|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266930|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266931|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266932|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266933|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266934|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266935|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266936|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266937|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266938|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266939|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266940|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266941|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266942|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266943|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266944|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266945|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266946|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266947|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266948|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266949|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266950|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266951|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266952|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266953|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266954|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266955|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266956|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266957|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266958|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266959|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266960|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266961|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266962|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266963|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266964|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266965|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266966|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266967|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266968|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266969|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266970|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266971|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266972|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266973|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266974|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266975|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266976|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266977|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266978|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266979|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266980|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266981|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266982|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266983|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266984|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266985|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266986|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266987|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
266988|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
266989|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
266990|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266991|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266992|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266993|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266994|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
266995|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
266996|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
266997|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
266998|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
266999|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
267000|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
267001|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
267002|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
267003|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
267004|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
267005|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
267006|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
267007|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
267008|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
267009|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
267010|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
267011|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
267012|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
267013|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
267014|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
267015|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
267016|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
267017|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
267018|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
267019|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
267020|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
267021|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
267022|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
267023|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
267024|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
267025|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
267026|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
267027|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
267028|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
267029|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
268239|NCT01335789|O2|Outcome|Saline|"intranasal administration~Saline: 40 IUs"
267030|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
267031|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
267032|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
267033|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
267034|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
267035|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
267036|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
267037|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
267038|NCT01340027|E12|Reported Event|Solifenacin 10 mg and Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
267039|NCT01340027|E11|Reported Event|Solifenacin 10 mg and Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
267040|NCT01340027|E10|Reported Event|Solifenacin 5 mg and Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
267041|NCT01340027|E9|Reported Event|Solifenacin 5 mg and Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
267042|NCT01340027|E8|Reported Event|Solifenacin 2.5 mg and Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
267043|NCT01340027|E7|Reported Event|Solifenacin 2.5 mg and Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
267044|NCT01340027|E6|Reported Event|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
267045|NCT01340027|E5|Reported Event|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
267046|NCT01340027|E4|Reported Event|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
267047|NCT01340027|E3|Reported Event|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
267048|NCT01340027|E2|Reported Event|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
267049|NCT01340027|E1|Reported Event|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
267050|NCT01340014|B3|Baseline|Total|Total of all reporting groups
267051|NCT01340014|B2|Baseline|COSOPT/AZARGA|1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop AZARGA instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods.
267052|NCT01340014|B1|Baseline|AZARGA/COSOPT|1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop COSOPT instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods.
267053|NCT01340014|P2|Participant Flow|COSOPT/AZARGA|1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop AZARGA instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods.
267054|NCT01340014|P1|Participant Flow|AZARGA/COSOPT|1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop COSOPT instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods.
267055|NCT01340014|O2|Outcome|COSOPT|1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1 or Period 2
267056|NCT01340014|O1|Outcome|AZARGA|1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1 or Period 2
267057|NCT01340014|O2|Outcome|COSOPT|1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1 or Period 2
267058|NCT01340014|O1|Outcome|AZARGA|1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1 or Period 2
267059|NCT01340014|E2|Reported Event|COSOPT|1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1 or Period 2
267060|NCT01340014|E1|Reported Event|AZARGA|1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1 or Period 2
267061|NCT01339936|B1|Baseline|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
267062|NCT01339936|P1|Participant Flow|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
267063|NCT01339936|O1|Outcome|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
267064|NCT01339936|O1|Outcome|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
267065|NCT01339936|O1|Outcome|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
267066|NCT01339936|E1|Reported Event|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
267067|NCT01339923|B8|Baseline|TOTAL|Total of all reporting groups
267068|NCT01339923|B7|Baseline|C_35_12|Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.
267069|NCT01339923|B6|Baseline|BC_35_12|Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.
268231|NCT01335867|E1|Reported Event|Vigabatrin|Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks
267070|NCT01339923|B5|Baseline|B_02_6_10|Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
267071|NCT01339923|B4|Baseline|B_02_2_5|Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
267072|NCT01339923|B3|Baseline|B_68_11|Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.
267073|NCT01339923|B2|Baseline|B_3h5_11|Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.
267074|NCT01339923|B1|Baseline|B_2h3h5_11|Subjects, approximately 2.5 months of age received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.
267075|NCT01339923|P7|Participant Flow|C_35_12|Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.
267076|NCT01339923|P6|Participant Flow|BC_35_12|Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.
267077|NCT01339923|P5|Participant Flow|B_02_6_10|Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
267078|NCT01339923|P4|Participant Flow|B_02_2_5|Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
267079|NCT01339923|P3|Participant Flow|B_68_11|Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.
267080|NCT01339923|P2|Participant Flow|B_3h5_11|Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.
267081|NCT01339923|P1|Participant Flow|B_2h3h5_11|Subjects, approximately 2.5 months of age received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.
267082|NCT01339923|O2|Outcome|C_35_12|"Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 13,15 rMenB + OMV vaccine"
267083|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
267084|NCT01339923|O2|Outcome|B_02_6_10|"Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
267085|NCT01339923|O1|Outcome|B_02_2_5|"Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
267086|NCT01339923|O3|Outcome|B_68_11b|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. Blood draw at 8, 9, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
267087|NCT01339923|O2|Outcome|B_3h5_11b|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 5, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)"
267088|NCT01339923|O1|Outcome|B_2h3h5_11b|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 3.5, 6, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
267089|NCT01339923|O2|Outcome|C_35_12|"Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 13,15 rMenB + OMV vaccine"
267090|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
267091|NCT01339923|O2|Outcome|C_35_12|"Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 13,15 rMenB + OMV vaccine"
267131|NCT01339923|O1|Outcome|B_2h3h5_11b|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 3.5, 6, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
268232|NCT01335789|B3|Baseline|Total|Total of all reporting groups
267092|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
267093|NCT01339923|O2|Outcome|B_02_6_10|"Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
267094|NCT01339923|O1|Outcome|B_02_2_5|"Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
267095|NCT01339923|O2|Outcome|B_02_6_10|"Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
267096|NCT01339923|O1|Outcome|B_02_2_5|"Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
267097|NCT01339923|O3|Outcome|B_68_11|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
267098|NCT01339923|O2|Outcome|B_3h5_11|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)"
267099|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
267100|NCT01339923|O3|Outcome|B_68_11b|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. Blood draw at 8, 9, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
267101|NCT01339923|O2|Outcome|B_3h5_11b|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 5, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)"
267102|NCT01339923|O1|Outcome|B_2h3h5_11b|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 3.5, 6, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
267103|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
267104|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
267105|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
267106|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
267107|NCT01339923|O2|Outcome|C_35_12|"Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 ad 15 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 13,15 rMenB + OMV vaccine"
267108|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5 12 rMenB + OMV vaccine"
267109|NCT01339923|O2|Outcome|C_35_12|"Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 13,15 rMenB + OMV vaccine"
268233|NCT01335789|B2|Baseline|Saline|"intranasal administration~Saline: 40 IUs"
267110|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
267111|NCT01339923|O2|Outcome|C_35_12|"Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 13,15 rMenB + OMV vaccine"
267112|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
267113|NCT01339923|O1|Outcome|B_02|"Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
267114|NCT01339923|O3|Outcome|B_68_11|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
267115|NCT01339923|O2|Outcome|B_3h5_11|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)"
267116|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
267117|NCT01339923|O3|Outcome|B_68_11|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
267118|NCT01339923|O2|Outcome|B_3h5_11|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (3.5, 5 months of age) plus booster (11 months of age)"
267119|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
267120|NCT01339923|O3|Outcome|B_68_11|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
267121|NCT01339923|O2|Outcome|B_3h5_11|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (3.5, 5 months of age) plus booster (11 months of age)"
267122|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
267123|NCT01339923|O3|Outcome|B_68_11|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
267124|NCT01339923|O2|Outcome|B_3h5_11|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)"
267125|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
267126|NCT01339923|O3|Outcome|B_68_11b|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. Blood draw at 8, 9, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
267127|NCT01339923|O2|Outcome|B_3h5_11b|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 5, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)"
267128|NCT01339923|O1|Outcome|B_2h3h5_11b|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 3.5, 6, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
267129|NCT01339923|O3|Outcome|B_68_11b|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. Blood draw at 8, 9, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
267130|NCT01339923|O2|Outcome|B_3h5_11b|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 5, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (3.5, 5 months of age) plus booster (11 months of age)"
267949|NCT01336647|P2|Participant Flow|High-Dose Ha44|High-Dose Ha44 Gel 0.74% it was administered topically for 10 minutes as a single dose
267132|NCT01339923|O4|Outcome|B_02|"Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
267133|NCT01339923|O3|Outcome|B_68_11|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
267134|NCT01339923|O2|Outcome|B_3h5_11|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (3.5, 5 months of age) plus booster (11 months of age)"
267135|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
267136|NCT01339923|O1|Outcome|B_02|"Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
267137|NCT01339923|O1|Outcome|B_02|"Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
267138|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months of age) plus booster (11 months of age)"
267139|NCT01339923|O2|Outcome|B_68_11|Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.
267140|NCT01339923|O1|Outcome|B_3h5_11|Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.
267141|NCT01339923|E8|Reported Event|TOTAL|All subjects in the safety population.
267142|NCT01339923|E7|Reported Event|C_35_12|Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.
267143|NCT01339923|E6|Reported Event|BC_35_12|Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.
267144|NCT01339923|E5|Reported Event|B_02_6_10|Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
267145|NCT01339923|E4|Reported Event|B_02_2_5|Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
267146|NCT01339923|E3|Reported Event|B_68_11|Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.
267147|NCT01339923|E2|Reported Event|B_3h5_11|Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.
267148|NCT01339923|E1|Reported Event|B_2h3h5_11|Subjects, approximately 2.5 months of age received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.
267149|NCT01339910|B3|Baseline|Total|Total of all reporting groups
267150|NCT01339910|B2|Baseline|Reduced Intensity Conditioning (RIC)|"One of two different regimens in RIC will be administered; fludarabine and busulfan, or fludarabine and melphalan.~Fludarabine and Busulfan: (Flu/Bu)~Fludarabine: 30 mg/m^2/day on Days -6 to -2 (total dose of 150 mg/m^2)~Busulfan: 4 mg/kg/day PO or 3.2 mg/kg/day (total dose of 8 mg/kg or 6.4 mg/kg, respectively) on Days -5 to -4~Fludarabine and Melphalan: (Flu/Mel)~Fludarabine: 30 mg/m^2/day on Days -5 to -2 (total dose of 120 mg/m^2)~Melphalan: 140 mg/m^2 on Day -2"
267151|NCT01339910|B1|Baseline|Myeloablative Conditioning Regimen (MAC)|"One of three different regimens in MAC will be administered; busulfan and fludarabine, busulfan and cyclophosphamide, or cyclophosphamide and total body irradiation.~Busulfan and Fludarabine: (Bu/Flu)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or mg/m^2/day with Bu Css 900±100 ng/mL (total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m^2, respectively) on Days -5 to -2~Fludarabine: 30 mg/m^2/day on Days -5 to -2: Flu (total dose of 120 mg/m^2)~Busulfan and Cyclophosphamide: (Bu/Cy)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or 130 mg/m^2/day with Bu Css 900 ± 100 ng/mL (total dose of 16 mg/kg or 12.8 mg/kg or 520 mg/m^2, respectively) on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)~Cyclophosphamide and Total Body Irradiation: (Cy/TBI)~TBI: 1200-1420 cGy on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)"
267152|NCT01339910|P2|Participant Flow|Reduced Intensity Conditioning (RIC)|"One of two different regimens in RIC will be administered; fludarabine and busulfan, or fludarabine and melphalan.~Fludarabine and Busulfan: (Flu/Bu)~Fludarabine: 30 mg/m^2/day on Days -6 to -2 (total dose of 150 mg/m^2)~Busulfan: 4 mg/kg/day PO or 3.2 mg/kg/day (total dose of 8 mg/kg or 6.4 mg/kg, respectively) on Days -5 to -4~Fludarabine and Melphalan: (Flu/Mel)~Fludarabine: 30 mg/m^2/day on Days -5 to -2 (total dose of 120 mg/m^2)~Melphalan: 140 mg/m^2 on Day -2"
267153|NCT01339910|P1|Participant Flow|Myeloablative Conditioning Regimen (MAC)|"One of three different regimens in MAC will be administered; busulfan and fludarabine, busulfan and cyclophosphamide, or cyclophosphamide and total body irradiation.~Busulfan and Fludarabine: (Bu/Flu)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or mg/m^2/day with Bu Css 900±100 ng/mL (total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m^2, respectively) on Days -5 to -2~Fludarabine: 30 mg/m^2/day on Days -5 to -2: Flu (total dose of 120 mg/m^2)~Busulfan and Cyclophosphamide: (Bu/Cy)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or 130 mg/m^2/day with Bu Css 900 ± 100 ng/mL (total dose of 16 mg/kg or 12.8 mg/kg or 520 mg/m^2, respectively) on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)~Cyclophosphamide and Total Body Irradiation: (Cy/TBI)~TBI: 1200-1420 cGy on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)"
267255|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
268234|NCT01335789|B1|Baseline|Oxytocin|"intranasal administration~Oxytocin: 40 IUs"
267154|NCT01339910|O2|Outcome|Reduced Intensity Conditioning (RIC)|"One of two different regimens in RIC will be administered; fludarabine and busulfan, or fludarabine and melphalan.~Fludarabine and Busulfan: (Flu/Bu)~Fludarabine: 30 mg/m^2/day on Days -6 to -2 (total dose of 150 mg/m^2)~Busulfan: 4 mg/kg/day PO or 3.2 mg/kg/day (total dose of 8 mg/kg or 6.4 mg/kg, respectively) on Days -5 to -4~Fludarabine and Melphalan: (Flu/Mel)~Fludarabine: 30 mg/m^2/day on Days -5 to -2 (total dose of 120 mg/m^2)~Melphalan: 140 mg/m^2 on Day -2"
267155|NCT01339910|O1|Outcome|Myeloablative Conditioning Regimen (MAC)|"One of three different regimens in MAC will be administered; busulfan and fludarabine, busulfan and cyclophosphamide, or cyclophosphamide and total body irradiation.~Busulfan and Fludarabine: (Bu/Flu)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or mg/m^2/day with Bu Css 900±100 ng/mL (total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m^2, respectively) on Days -5 to -2~Fludarabine: 30 mg/m^2/day on Days -5 to -2: Flu (total dose of 120 mg/m^2)~Busulfan and Cyclophosphamide: (Bu/Cy)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or 130 mg/m^2/day with Bu Css 900 ± 100 ng/mL (total dose of 16 mg/kg or 12.8 mg/kg or 520 mg/m^2, respectively) on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)~Cyclophosphamide and Total Body Irradiation: (Cy/TBI)~TBI: 1200-1420 cGy on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)"
267156|NCT01339910|O2|Outcome|Reduced Intensity Conditioning (RIC)|"One of two different regimens in RIC will be administered; fludarabine and busulfan, or fludarabine and melphalan.~Fludarabine and Busulfan: (Flu/Bu)~Fludarabine: 30 mg/m^2/day on Days -6 to -2 (total dose of 150 mg/m^2)~Busulfan: 4 mg/kg/day PO or 3.2 mg/kg/day (total dose of 8 mg/kg or 6.4 mg/kg, respectively) on Days -5 to -4~Fludarabine and Melphalan: (Flu/Mel)~Fludarabine: 30 mg/m^2/day on Days -5 to -2 (total dose of 120 mg/m^2)~Melphalan: 140 mg/m^2 on Day -2"
267157|NCT01339910|O1|Outcome|Myeloablative Conditioning Regimen (MAC)|"One of three different regimens in MAC will be administered; busulfan and fludarabine, busulfan and cyclophosphamide, or cyclophosphamide and total body irradiation.~Busulfan and Fludarabine: (Bu/Flu)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or mg/m^2/day with Bu Css 900±100 ng/mL (total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m^2, respectively) on Days -5 to -2~Fludarabine: 30 mg/m^2/day on Days -5 to -2: Flu (total dose of 120 mg/m^2)~Busulfan and Cyclophosphamide: (Bu/Cy)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or 130 mg/m^2/day with Bu Css 900 ± 100 ng/mL (total dose of 16 mg/kg or 12.8 mg/kg or 520 mg/m^2, respectively) on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)~Cyclophosphamide and Total Body Irradiation: (Cy/TBI)~TBI: 1200-1420 cGy on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)"
267158|NCT01339910|O2|Outcome|Reduced Intensity Conditioning (RIC)|"One of two different regimens in RIC will be administered; fludarabine and busulfan, or fludarabine and melphalan.~Fludarabine and Busulfan: (Flu/Bu)~Fludarabine: 30 mg/m^2/day on Days -6 to -2 (total dose of 150 mg/m^2)~Busulfan: 4 mg/kg/day PO or 3.2 mg/kg/day (total dose of 8 mg/kg or 6.4 mg/kg, respectively) on Days -5 to -4~Fludarabine and Melphalan: (Flu/Mel)~Fludarabine: 30 mg/m^2/day on Days -5 to -2 (total dose of 120 mg/m^2)~Melphalan: 140 mg/m^2 on Day -2"
267159|NCT01339910|O1|Outcome|Myeloablative Conditioning Regimen (MAC)|"One of three different regimens in MAC will be administered; busulfan and fludarabine, busulfan and cyclophosphamide, or cyclophosphamide and total body irradiation.~Busulfan and Fludarabine: (Bu/Flu)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or mg/m^2/day with Bu Css 900±100 ng/mL (total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m^2, respectively) on Days -5 to -2~Fludarabine: 30 mg/m^2/day on Days -5 to -2: Flu (total dose of 120 mg/m^2)~Busulfan and Cyclophosphamide: (Bu/Cy)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or 130 mg/m^2/day with Bu Css 900 ± 100 ng/mL (total dose of 16 mg/kg or 12.8 mg/kg or 520 mg/m^2, respectively) on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)~Cyclophosphamide and Total Body Irradiation: (Cy/TBI)~TBI: 1200-1420 cGy on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)"
267160|NCT01339910|O2|Outcome|Reduced Intensity Conditioning (RIC)|"One of two different regimens in RIC will be administered; fludarabine and busulfan, or fludarabine and melphalan.~Fludarabine and Busulfan: (Flu/Bu)~Fludarabine: 30 mg/m^2/day on Days -6 to -2 (total dose of 150 mg/m^2)~Busulfan: 4 mg/kg/day PO or 3.2 mg/kg/day (total dose of 8 mg/kg or 6.4 mg/kg, respectively) on Days -5 to -4~Fludarabine and Melphalan: (Flu/Mel)~Fludarabine: 30 mg/m^2/day on Days -5 to -2 (total dose of 120 mg/m^2)~Melphalan: 140 mg/m^2 on Day -2"
267161|NCT01339910|O1|Outcome|Myeloablative Conditioning Regimen (MAC)|"One of three different regimens in MAC will be administered; busulfan and fludarabine, busulfan and cyclophosphamide, or cyclophosphamide and total body irradiation.~Busulfan and Fludarabine: (Bu/Flu)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or mg/m^2/day with Bu Css 900±100 ng/mL (total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m^2, respectively) on Days -5 to -2~Fludarabine: 30 mg/m^2/day on Days -5 to -2: Flu (total dose of 120 mg/m^2)~Busulfan and Cyclophosphamide: (Bu/Cy)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or 130 mg/m^2/day with Bu Css 900 ± 100 ng/mL (total dose of 16 mg/kg or 12.8 mg/kg or 520 mg/m^2, respectively) on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)~Cyclophosphamide and Total Body Irradiation: (Cy/TBI)~TBI: 1200-1420 cGy on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)"
267162|NCT01339910|O2|Outcome|Reduced Intensity Conditioning (RIC)|"One of two different regimens in RIC will be administered; fludarabine and busulfan, or fludarabine and melphalan.~Fludarabine and Busulfan: (Flu/Bu)~Fludarabine: 30 mg/m^2/day on Days -6 to -2 (total dose of 150 mg/m^2)~Busulfan: 4 mg/kg/day PO or 3.2 mg/kg/day (total dose of 8 mg/kg or 6.4 mg/kg, respectively) on Days -5 to -4~Fludarabine and Melphalan: (Flu/Mel)~Fludarabine: 30 mg/m^2/day on Days -5 to -2 (total dose of 120 mg/m^2)~Melphalan: 140 mg/m^2 on Day -2"
267163|NCT01339910|O1|Outcome|Myeloablative Conditioning Regimen (MAC)|"One of three different regimens in MAC will be administered; busulfan and fludarabine, busulfan and cyclophosphamide, or cyclophosphamide and total body irradiation.~Busulfan and Fludarabine: (Bu/Flu)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or mg/m^2/day with Bu Css 900±100 ng/mL (total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m^2, respectively) on Days -5 to -2~Fludarabine: 30 mg/m^2/day on Days -5 to -2: Flu (total dose of 120 mg/m^2)~Busulfan and Cyclophosphamide: (Bu/Cy)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or 130 mg/m^2/day with Bu Css 900 ± 100 ng/mL (total dose of 16 mg/kg or 12.8 mg/kg or 520 mg/m^2, respectively) on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)~Cyclophosphamide and Total Body Irradiation: (Cy/TBI)~TBI: 1200-1420 cGy on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)"
267256|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
267164|NCT01339910|O2|Outcome|Reduced Intensity Conditioning (RIC)|"One of two different regimens in RIC will be administered; fludarabine and busulfan, or fludarabine and melphalan.~Fludarabine and Busulfan: (Flu/Bu)~Fludarabine: 30 mg/m^2/day on Days -6 to -2 (total dose of 150 mg/m^2)~Busulfan: 4 mg/kg/day PO or 3.2 mg/kg/day (total dose of 8 mg/kg or 6.4 mg/kg, respectively) on Days -5 to -4~Fludarabine and Melphalan: (Flu/Mel)~Fludarabine: 30 mg/m^2/day on Days -5 to -2 (total dose of 120 mg/m^2)~Melphalan: 140 mg/m^2 on Day -2"
267165|NCT01339910|O1|Outcome|Myeloablative Conditioning Regimen (MAC)|"One of three different regimens in MAC will be administered; busulfan and fludarabine, busulfan and cyclophosphamide, or cyclophosphamide and total body irradiation.~Busulfan and Fludarabine: (Bu/Flu)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or mg/m^2/day with Bu Css 900±100 ng/mL (total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m^2, respectively) on Days -5 to -2~Fludarabine: 30 mg/m^2/day on Days -5 to -2: Flu (total dose of 120 mg/m^2)~Busulfan and Cyclophosphamide: (Bu/Cy)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or 130 mg/m^2/day with Bu Css 900 ± 100 ng/mL (total dose of 16 mg/kg or 12.8 mg/kg or 520 mg/m^2, respectively) on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)~Cyclophosphamide and Total Body Irradiation: (Cy/TBI)~TBI: 1200-1420 cGy on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)"
267166|NCT01339910|O2|Outcome|Reduced Intensity Conditioning (RIC)|"One of two different regimens in RIC will be administered; fludarabine and busulfan, or fludarabine and melphalan.~Fludarabine and Busulfan: (Flu/Bu)~Fludarabine: 30 mg/m^2/day on Days -6 to -2 (total dose of 150 mg/m^2)~Busulfan: 4 mg/kg/day PO or 3.2 mg/kg/day (total dose of 8 mg/kg or 6.4 mg/kg, respectively) on Days -5 to -4~Fludarabine and Melphalan: (Flu/Mel)~Fludarabine: 30 mg/m^2/day on Days -5 to -2 (total dose of 120 mg/m^2)~Melphalan: 140 mg/m^2 on Day -2"
267167|NCT01339910|O1|Outcome|Myeloablative Conditioning Regimen (MAC)|"One of three different regimens in MAC will be administered; busulfan and fludarabine, busulfan and cyclophosphamide, or cyclophosphamide and total body irradiation.~Busulfan and Fludarabine: (Bu/Flu)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or mg/m^2/day with Bu Css 900±100 ng/mL (total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m^2, respectively) on Days -5 to -2~Fludarabine: 30 mg/m^2/day on Days -5 to -2: Flu (total dose of 120 mg/m^2)~Busulfan and Cyclophosphamide: (Bu/Cy)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or 130 mg/m^2/day with Bu Css 900 ± 100 ng/mL (total dose of 16 mg/kg or 12.8 mg/kg or 520 mg/m^2, respectively) on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)~Cyclophosphamide and Total Body Irradiation: (Cy/TBI)~TBI: 1200-1420 cGy on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)"
267168|NCT01339910|O2|Outcome|Reduced Intensity Conditioning (RIC)|"One of two different regimens in RIC will be administered; fludarabine and busulfan, or fludarabine and melphalan.~Fludarabine and Busulfan: (Flu/Bu)~Fludarabine: 30 mg/m^2/day on Days -6 to -2 (total dose of 150 mg/m^2)~Busulfan: 4 mg/kg/day PO or 3.2 mg/kg/day (total dose of 8 mg/kg or 6.4 mg/kg, respectively) on Days -5 to -4~Fludarabine and Melphalan: (Flu/Mel)~Fludarabine: 30 mg/m^2/day on Days -5 to -2 (total dose of 120 mg/m^2)~Melphalan: 140 mg/m^2 on Day -2"
267169|NCT01339910|O1|Outcome|Myeloablative Conditioning Regimen (MAC)|"One of three different regimens in MAC will be administered; busulfan and fludarabine, busulfan and cyclophosphamide, or cyclophosphamide and total body irradiation.~Busulfan and Fludarabine: (Bu/Flu)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or mg/m^2/day with Bu Css 900±100 ng/mL (total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m^2, respectively) on Days -5 to -2~Fludarabine: 30 mg/m^2/day on Days -5 to -2: Flu (total dose of 120 mg/m^2)~Busulfan and Cyclophosphamide: (Bu/Cy)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or 130 mg/m^2/day with Bu Css 900 ± 100 ng/mL (total dose of 16 mg/kg or 12.8 mg/kg or 520 mg/m^2, respectively) on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)~Cyclophosphamide and Total Body Irradiation: (Cy/TBI)~TBI: 1200-1420 cGy on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)"
267170|NCT01339910|O2|Outcome|Reduced Intensity Conditioning (RIC)|"One of two different regimens in RIC will be administered; fludarabine and busulfan, or fludarabine and melphalan.~Fludarabine and Busulfan: (Flu/Bu)~Fludarabine: 30 mg/m^2/day on Days -6 to -2 (total dose of 150 mg/m^2)~Busulfan: 4 mg/kg/day PO or 3.2 mg/kg/day (total dose of 8 mg/kg or 6.4 mg/kg, respectively) on Days -5 to -4~Fludarabine and Melphalan: (Flu/Mel)~Fludarabine: 30 mg/m^2/day on Days -5 to -2 (total dose of 120 mg/m^2)~Melphalan: 140 mg/m^2 on Day -2"
267171|NCT01339910|O1|Outcome|Myeloablative Conditioning Regimen (MAC)|"One of three different regimens in MAC will be administered; busulfan and fludarabine, busulfan and cyclophosphamide, or cyclophosphamide and total body irradiation.~Busulfan and Fludarabine: (Bu/Flu)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or mg/m^2/day with Bu Css 900±100 ng/mL (total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m^2, respectively) on Days -5 to -2~Fludarabine: 30 mg/m^2/day on Days -5 to -2: Flu (total dose of 120 mg/m^2)~Busulfan and Cyclophosphamide: (Bu/Cy)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or 130 mg/m^2/day with Bu Css 900 ± 100 ng/mL (total dose of 16 mg/kg or 12.8 mg/kg or 520 mg/m^2, respectively) on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)~Cyclophosphamide and Total Body Irradiation: (Cy/TBI)~TBI: 1200-1420 cGy on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)"
267172|NCT01339910|O2|Outcome|Reduced Intensity Conditioning (RIC)|"One of two different regimens in RIC will be administered; fludarabine and busulfan, or fludarabine and melphalan.~Fludarabine and Busulfan: (Flu/Bu)~Fludarabine: 30 mg/m^2/day on Days -6 to -2 (total dose of 150 mg/m^2)~Busulfan: 4 mg/kg/day PO or 3.2 mg/kg/day (total dose of 8 mg/kg or 6.4 mg/kg, respectively) on Days -5 to -4~Fludarabine and Melphalan: (Flu/Mel)~Fludarabine: 30 mg/m^2/day on Days -5 to -2 (total dose of 120 mg/m^2)~Melphalan: 140 mg/m^2 on Day -2"
267173|NCT01339910|O1|Outcome|Myeloablative Conditioning Regimen (MAC)|"One of three different regimens in MAC will be administered; busulfan and fludarabine, busulfan and cyclophosphamide, or cyclophosphamide and total body irradiation.~Busulfan and Fludarabine: (Bu/Flu)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or mg/m^2/day with Bu Css 900±100 ng/mL (total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m^2, respectively) on Days -5 to -2~Fludarabine: 30 mg/m^2/day on Days -5 to -2: Flu (total dose of 120 mg/m^2)~Busulfan and Cyclophosphamide: (Bu/Cy)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or 130 mg/m^2/day with Bu Css 900 ± 100 ng/mL (total dose of 16 mg/kg or 12.8 mg/kg or 520 mg/m^2, respectively) on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)~Cyclophosphamide and Total Body Irradiation: (Cy/TBI)~TBI: 1200-1420 cGy on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)"
267257|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
267174|NCT01339910|O2|Outcome|Reduced Intensity Conditioning (RIC)|"One of two different regimens in RIC will be administered; fludarabine and busulfan, or fludarabine and melphalan.~Fludarabine and Busulfan: (Flu/Bu)~Fludarabine: 30 mg/m^2/day on Days -6 to -2 (total dose of 150 mg/m^2)~Busulfan: 4 mg/kg/day PO or 3.2 mg/kg/day (total dose of 8 mg/kg or 6.4 mg/kg, respectively) on Days -5 to -4~Fludarabine and Melphalan: (Flu/Mel)~Fludarabine: 30 mg/m^2/day on Days -5 to -2 (total dose of 120 mg/m^2)~Melphalan: 140 mg/m^2 on Day -2"
267175|NCT01339910|O1|Outcome|Myeloablative Conditioning Regimen (MAC)|"One of three different regimens in MAC will be administered; busulfan and fludarabine, busulfan and cyclophosphamide, or cyclophosphamide and total body irradiation.~Busulfan and Fludarabine: (Bu/Flu)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or mg/m^2/day with Bu Css 900±100 ng/mL (total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m^2, respectively) on Days -5 to -2~Fludarabine: 30 mg/m^2/day on Days -5 to -2: Flu (total dose of 120 mg/m^2)~Busulfan and Cyclophosphamide: (Bu/Cy)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or 130 mg/m^2/day with Bu Css 900 ± 100 ng/mL (total dose of 16 mg/kg or 12.8 mg/kg or 520 mg/m^2, respectively) on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)~Cyclophosphamide and Total Body Irradiation: (Cy/TBI)~TBI: 1200-1420 cGy on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)"
267176|NCT01339910|O2|Outcome|Reduced Intensity Conditioning (RIC)|"One of two different regimens in RIC will be administered; fludarabine and busulfan, or fludarabine and melphalan.~Fludarabine and Busulfan: (Flu/Bu)~Fludarabine: 30 mg/m^2/day on Days -6 to -2 (total dose of 150 mg/m^2)~Busulfan: 4 mg/kg/day PO or 3.2 mg/kg/day (total dose of 8 mg/kg or 6.4 mg/kg, respectively) on Days -5 to -4~Fludarabine and Melphalan: (Flu/Mel)~Fludarabine: 30 mg/m^2/day on Days -5 to -2 (total dose of 120 mg/m^2)~Melphalan: 140 mg/m^2 on Day -2"
267177|NCT01339910|O1|Outcome|Myeloablative Conditioning Regimen (MAC)|"One of three different regimens in MAC will be administered; busulfan and fludarabine, busulfan and cyclophosphamide, or cyclophosphamide and total body irradiation.~Busulfan and Fludarabine: (Bu/Flu)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or mg/m^2/day with Bu Css 900±100 ng/mL (total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m^2, respectively) on Days -5 to -2~Fludarabine: 30 mg/m^2/day on Days -5 to -2: Flu (total dose of 120 mg/m^2)~Busulfan and Cyclophosphamide: (Bu/Cy)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or 130 mg/m^2/day with Bu Css 900 ± 100 ng/mL (total dose of 16 mg/kg or 12.8 mg/kg or 520 mg/m^2, respectively) on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)~Cyclophosphamide and Total Body Irradiation: (Cy/TBI)~TBI: 1200-1420 cGy on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)"
267178|NCT01339910|O2|Outcome|Reduced Intensity Conditioning (RIC)|"One of two different regimens in RIC will be administered; fludarabine and busulfan, or fludarabine and melphalan.~Fludarabine and Busulfan: (Flu/Bu)~Fludarabine: 30 mg/m^2/day on Days -6 to -2 (total dose of 150 mg/m^2)~Busulfan: 4 mg/kg/day PO or 3.2 mg/kg/day (total dose of 8 mg/kg or 6.4 mg/kg, respectively) on Days -5 to -4~Fludarabine and Melphalan: (Flu/Mel)~Fludarabine: 30 mg/m^2/day on Days -5 to -2 (total dose of 120 mg/m^2)~Melphalan: 140 mg/m^2 on Day -2"
267179|NCT01339910|O1|Outcome|Myeloablative Conditioning Regimen (MAC)|"One of three different regimens in MAC will be administered; busulfan and fludarabine, busulfan and cyclophosphamide, or cyclophosphamide and total body irradiation.~Busulfan and Fludarabine: (Bu/Flu)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or mg/m^2/day with Bu Css 900±100 ng/mL (total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m^2, respectively) on Days -5 to -2~Fludarabine: 30 mg/m^2/day on Days -5 to -2: Flu (total dose of 120 mg/m^2)~Busulfan and Cyclophosphamide: (Bu/Cy)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or 130 mg/m^2/day with Bu Css 900 ± 100 ng/mL (total dose of 16 mg/kg or 12.8 mg/kg or 520 mg/m^2, respectively) on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)~Cyclophosphamide and Total Body Irradiation: (Cy/TBI)~TBI: 1200-1420 cGy on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)"
267180|NCT01339910|O2|Outcome|Reduced Intensity Conditioning (RIC)|"One of two different regimens in RIC will be administered; fludarabine and busulfan, or fludarabine and melphalan.~Fludarabine and Busulfan: (Flu/Bu)~Fludarabine: 30 mg/m^2/day on Days -6 to -2 (total dose of 150 mg/m^2)~Busulfan: 4 mg/kg/day PO or 3.2 mg/kg/day (total dose of 8 mg/kg or 6.4 mg/kg, respectively) on Days -5 to -4~Fludarabine and Melphalan: (Flu/Mel)~Fludarabine: 30 mg/m^2/day on Days -5 to -2 (total dose of 120 mg/m^2)~Melphalan: 140 mg/m^2 on Day -2"
267181|NCT01339910|O1|Outcome|Myeloablative Conditioning Regimen (MAC)|"One of three different regimens in MAC will be administered; busulfan and fludarabine, busulfan and cyclophosphamide, or cyclophosphamide and total body irradiation.~Busulfan and Fludarabine: (Bu/Flu)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or mg/m^2/day with Bu Css 900±100 ng/mL (total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m^2, respectively) on Days -5 to -2~Fludarabine: 30 mg/m^2/day on Days -5 to -2: Flu (total dose of 120 mg/m^2)~Busulfan and Cyclophosphamide: (Bu/Cy)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or 130 mg/m^2/day with Bu Css 900 ± 100 ng/mL (total dose of 16 mg/kg or 12.8 mg/kg or 520 mg/m^2, respectively) on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)~Cyclophosphamide and Total Body Irradiation: (Cy/TBI)~TBI: 1200-1420 cGy on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)"
267182|NCT01339910|O2|Outcome|Reduced Intensity Conditioning (RIC)|"One of two different regimens in RIC will be administered; fludarabine and busulfan, or fludarabine and melphalan.~Fludarabine and Busulfan: (Flu/Bu)~Fludarabine: 30 mg/m^2/day on Days -6 to -2 (total dose of 150 mg/m^2)~Busulfan: 4 mg/kg/day PO or 3.2 mg/kg/day (total dose of 8 mg/kg or 6.4 mg/kg, respectively) on Days -5 to -4~Fludarabine and Melphalan: (Flu/Mel)~Fludarabine: 30 mg/m^2/day on Days -5 to -2 (total dose of 120 mg/m^2)~Melphalan: 140 mg/m^2 on Day -2"
267183|NCT01339910|O1|Outcome|Myeloablative Conditioning Regimen (MAC)|"One of three different regimens in MAC will be administered; busulfan and fludarabine, busulfan and cyclophosphamide, or cyclophosphamide and total body irradiation.~Busulfan and Fludarabine: (Bu/Flu)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or mg/m^2/day with Bu Css 900±100 ng/mL (total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m^2, respectively) on Days -5 to -2~Fludarabine: 30 mg/m^2/day on Days -5 to -2: Flu (total dose of 120 mg/m^2)~Busulfan and Cyclophosphamide: (Bu/Cy)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or 130 mg/m^2/day with Bu Css 900 ± 100 ng/mL (total dose of 16 mg/kg or 12.8 mg/kg or 520 mg/m^2, respectively) on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)~Cyclophosphamide and Total Body Irradiation: (Cy/TBI)~TBI: 1200-1420 cGy on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)"
267258|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
267184|NCT01339910|E2|Reported Event|Reduced Intensity Conditioning (RIC)|"One of two different regimens in RIC will be administered; fludarabine and busulfan, or fludarabine and melphalan.~Fludarabine and Busulfan: (Flu/Bu)~Fludarabine: 30 mg/m^2/day on Days -6 to -2 (total dose of 150 mg/m^2)~Busulfan: 4 mg/kg/day PO or 3.2 mg/kg/day (total dose of 8 mg/kg or 6.4 mg/kg, respectively) on Days -5 to -4~Fludarabine and Melphalan: (Flu/Mel)~Fludarabine: 30 mg/m^2/day on Days -5 to -2 (total dose of 120 mg/m^2)~Melphalan: 140 mg/m^2 on Day -2"
267185|NCT01339910|E1|Reported Event|Myeloablative Conditioning Regimen (MAC)|"One of three different regimens in MAC will be administered; busulfan and fludarabine, busulfan and cyclophosphamide, or cyclophosphamide and total body irradiation.~Busulfan and Fludarabine: (Bu/Flu)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or mg/m^2/day with Bu Css 900±100 ng/mL (total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m^2, respectively) on Days -5 to -2~Fludarabine: 30 mg/m^2/day on Days -5 to -2: Flu (total dose of 120 mg/m^2)~Busulfan and Cyclophosphamide: (Bu/Cy)~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or 130 mg/m^2/day with Bu Css 900 ± 100 ng/mL (total dose of 16 mg/kg or 12.8 mg/kg or 520 mg/m^2, respectively) on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)~Cyclophosphamide and Total Body Irradiation: (Cy/TBI)~TBI: 1200-1420 cGy on Days -7 to -4~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)"
267186|NCT01339897|B5|Baseline|Total|Total of all reporting groups
267187|NCT01339897|B4|Baseline|Placebo|Non-Active
267188|NCT01339897|B3|Baseline|Cohort 3|N6022 - Active 20 mg
267189|NCT01339897|B2|Baseline|Cohort 2|N6022 - Active 10 mg
267190|NCT01339897|B1|Baseline|Cohort 1|N6022 - Active 5 mg
267191|NCT01339897|P4|Participant Flow|20 mg/N6022|Active Group- 20 mg by IV administration (5 mg/minute)
267192|NCT01339897|P3|Participant Flow|10 mg/N6022|Active Group- 10 mg by IV administration (5 mg/minute)
267193|NCT01339897|P2|Participant Flow|Placebo|Non-Active
267194|NCT01339897|P1|Participant Flow|5 mg/N6022|Active Group- 5 mg by IV administration (5 mg/minute)
267195|NCT01339897|O4|Outcome|Placebo|Non-Active
267196|NCT01339897|O3|Outcome|Cohort 3|N6022 Active - 20 mg
267197|NCT01339897|O2|Outcome|Cohort 2|N6022 Active - 10 mg
267198|NCT01339897|O1|Outcome|Cohort 1|N6022 Active - 5 mg
267199|NCT01339897|O4|Outcome|Placebo|Non-Active
267200|NCT01339897|O3|Outcome|Cohort 3|N6022 Active - 20 mg
267201|NCT01339897|O2|Outcome|Cohort 2|N6022 Active - 10 mg
267202|NCT01339897|O1|Outcome|Cohort 1|N6022 Active - 5 mg
267203|NCT01339897|O4|Outcome|Placebo|Non-Active
267204|NCT01339897|O3|Outcome|Cohort 3|N6022 Active - 20 mg
267205|NCT01339897|O2|Outcome|Cohort 2|N6022 Active - 10 mg
267206|NCT01339897|O1|Outcome|Cohort 1|N6022 Active - 5 mg
267207|NCT01339897|O4|Outcome|Placebo|Non-Active
267208|NCT01339897|O3|Outcome|Cohort 3|N6022 Active - 20 mg
267209|NCT01339897|O2|Outcome|Cohort 2|N6022 Active - 10 mg
267210|NCT01339897|O1|Outcome|Cohort 1|N6022 Active - 5 mg
267211|NCT01339897|O4|Outcome|Placebo|Non-Active
267212|NCT01339897|O3|Outcome|Cohort 3|N6022 - Active 20 mg
267213|NCT01339897|O2|Outcome|Cohort 2|N6022 Active - 10 mg
267214|NCT01339897|O1|Outcome|Cohort 1|N6022 - Active 5 mg
267215|NCT01339897|E4|Reported Event|Placebo|Non-Active
267216|NCT01339897|E3|Reported Event|Cohort 3|N6022 - Active 20 mg
267217|NCT01339897|E2|Reported Event|Cohort 2|N6022 Active - 10 mg
267218|NCT01339897|E1|Reported Event|Cohort 1|N6022 - Active 5 mg
267219|NCT01339832|B1|Baseline|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
267220|NCT01339832|P1|Participant Flow|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
267221|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
267222|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
267223|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
267224|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
267225|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
267226|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
267227|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
267228|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
267229|NCT01339832|E1|Reported Event|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
267230|NCT01339429|B1|Baseline|Simplified Negative Pressure Wound Therapy|"The simplified Negative Pressure device will be placed on subjects selected from the hospital wards and meeting the eligibility criteria.~simplified Negative Pressure device: A non-powered negative pressure device utilizing a bellows which is compressed every eight hours."
267231|NCT01339429|P1|Participant Flow|Simplified Negative Pressure Wound Therapy|"The simplified negative pressure wound therapy device was placed on subjects selected from hospital wards and meeting the eligibility criteria regarding wound size and condition. Inclusion criteria included age 14 years or older, adequate adjacent intact skin and wound location for application of the sNPWT dressing, adequate pain control, and anticipated clinically stability and hospitalization for the duration of the study. Exclusion criteria were exposed blood vessels, evidence of ischemia, necrotic tissue requiring further debridement, infection, osteomyelitis, and malignancy in the wound.~Simplified negative pressure wound therapy device: A non-powered negative pressure wound therapy device utilizing a bellows connected to a specialized dressing via a drainage tube."
267232|NCT01339429|O1|Outcome|Simplified Negative Pressure Wound Therapy|"The simplified negative pressure wound therapy device will be placed on subjects selected from the surgical ward and meeting the eligibility criteria regarding wound size and condition.~Simplified negative pressure wound therapy device: A non-powered negative pressure wound therapy device utilizing a bellows connected to a specialized dressing."
267233|NCT01339429|O1|Outcome|Simplified Negative Pressure Wound Therapy|"The simplified negative pressure wound therapy device will be placed on subjects selected from the surgical ward and meeting the eligibility criteria regarding wound size and condition.~Simplified negative pressure wound therapy device: A non-powered negative pressure wound therapy device utilizing a bellows connected to a specialized dressing."
267234|NCT01339429|E1|Reported Event|Simplified Negative Pressure Wound Therapy|"The simplified negative pressure wound therapy device was placed on subjects selected from the hospital wards and meeting the eligibility criteria regarding wound size and condition.~Simplified negative pressure wound therapy device: A non-powered negative pressure wound therapy device utilizing a bellows connected to a specialized dressing."
267235|NCT01339416|B1|Baseline|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
267236|NCT01339416|P1|Participant Flow|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
267237|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
267238|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
267239|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
267240|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
267241|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
267242|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
267243|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
267244|NCT01339416|E1|Reported Event|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
267245|NCT01339403|B3|Baseline|Total|Total of all reporting groups
267246|NCT01339403|B2|Baseline|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
267247|NCT01339403|B1|Baseline|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
267248|NCT01339403|P2|Participant Flow|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
267249|NCT01339403|P1|Participant Flow|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
267250|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
267251|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
267252|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
267253|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
267254|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
268235|NCT01335789|P2|Participant Flow|Saline|"intranasal administration~Saline: 40 IUs"
267259|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
267260|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
267261|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
267262|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
267263|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
267264|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
267265|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
267266|NCT01339403|E2|Reported Event|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
267267|NCT01339403|E1|Reported Event|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
267268|NCT01339390|B3|Baseline|Total|Total of all reporting groups
267269|NCT01339390|B2|Baseline|Arm 2: MOVE!|"As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.~MOVE!: As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs."
267270|NCT01339390|B1|Baseline|Arm 1: MOVE OUT|"The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.~MOVE OUT: The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support."
267271|NCT01339390|P2|Participant Flow|Arm 2: MOVE!|"As part of routine care, all patients who are eligible for the present study are identified by a clinical reminder. This prompts the primary care provider (PCP) to determine if the person would benefit from a weight loss program, and to refer them to MOVE! if they and the patient agree that it would be beneficial. The MOVE! program in Milwaukee can be tailored by patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.~MOVE!: As part of routine care, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE! if they and the patient agree that it would be beneficial. The MOVE! program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs."
267272|NCT01339390|P1|Participant Flow|Arm 1: MOVE OUT|"The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE! program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.~MOVE OUT: The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support."
267273|NCT01339390|O2|Outcome|Arm 2: MOVE!|"As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.~MOVE!: As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs."
267294|NCT01339260|O1|Outcome|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
267295|NCT01339260|O2|Outcome|Palonosetron Plus Dexamethasone|"Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle~Palonosetron~Dexamethasone"
267274|NCT01339390|O1|Outcome|Arm 1: MOVE OUT|"The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.~MOVE OUT: The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support."
267275|NCT01339390|E2|Reported Event|Arm 2: MOVE!|"As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.~MOVE!: As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs."
267276|NCT01339390|E1|Reported Event|Arm 1: MOVE OUT|"The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.~MOVE OUT: The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support."
267277|NCT01339299|B3|Baseline|Total|Total of all reporting groups
267278|NCT01339299|B2|Baseline|Recombinant Luteinizing Hormone|"150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)~recombinant luteinizing hormone (r-LH) : administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
267279|NCT01339299|B1|Baseline|Recombinant Human Chorionic Gonadotrofin|"25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )~recombinant human chorionic gonadotropin (r-hCG) : administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
267280|NCT01339299|P2|Participant Flow|Recombinant Luteinizing Hormone|"150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)~recombinant luteinizing hormone (r-LH) : administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
267281|NCT01339299|P1|Participant Flow|Recombinant Human Chorionic Gonadotrofin|"25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )~recombinant human chorionic gonadotropin (r-hCG) : administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
267282|NCT01339299|O2|Outcome|Recombinant Luteinizing Hormone|"150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)~recombinant luteinizing hormone (r-LH) : administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
267283|NCT01339299|O1|Outcome|Recombinant Human Chorionic Gonadotrofin|"25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )~recombinant human chorionic gonadotropin (r-hCG) : administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
267284|NCT01339299|E2|Reported Event|Recombinant Luteinizing Hormone|"150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)~recombinant luteinizing hormone (r-LH) : administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
267285|NCT01339299|E1|Reported Event|Recombinant Human Chorionic Gonadotrofin|"25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )~recombinant human chorionic gonadotropin (r-hCG) : administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
267286|NCT01339260|B3|Baseline|Total|Total of all reporting groups
267287|NCT01339260|B2|Baseline|Palonosetron Plus Dexamethasone|"Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle~Palonosetron~Dexamethasone"
267288|NCT01339260|B1|Baseline|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
267289|NCT01339260|P2|Participant Flow|Palonosetron Plus Dexamethasone|"Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle~Palonosetron~Dexamethasone"
267290|NCT01339260|P1|Participant Flow|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
267291|NCT01339260|O2|Outcome|Palonosetron Plus Dexamethasone|"Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle~Palonosetron~Dexamethasone"
267292|NCT01339260|O1|Outcome|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
267293|NCT01339260|O2|Outcome|Palonosetron Plus Dexamethasone|"Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle~Palonosetron~Dexamethasone"
267296|NCT01339260|O1|Outcome|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
267297|NCT01339260|E4|Reported Event|Palonosetron+Dexamethasone-multicycle Extension|Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle
267298|NCT01339260|E3|Reported Event|Netupitant and Palonosetron+Dexamethasone-multicycle Extension|Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle
267299|NCT01339260|E2|Reported Event|Palonosetron+Dexamethasone-cycle 1|Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle
267300|NCT01339260|E1|Reported Event|Netupitant and Palonosetron+Dexamethasone-cycle 1|Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle
267301|NCT01339247|B1|Baseline|Participants Receiving Both Test and Reference Product|Participants receiving either test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga – Canada in Period 1; followed by reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2 or reference product in Period 1 and test product in Period 2
267302|NCT01339247|P2|Participant Flow|Reference Product in Period 1; Test Product in Period 2|Reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 1; followed by test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 2
267303|NCT01339247|P1|Participant Flow|Test Product in Period 1; Reference Product in Period 2|Test product: paroxetine hydrochloride tablet with controlled release (Paxil CR) 25 milligrams (mg) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 1; followed by reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2
267304|NCT01339247|O2|Outcome|Reference Product|Reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods
267305|NCT01339247|O1|Outcome|Test Product|Test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods
267306|NCT01339247|O2|Outcome|Reference Product|Reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods
267307|NCT01339247|O1|Outcome|Test Product|Test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods
267308|NCT01339247|O2|Outcome|Reference Product|Reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods
267309|NCT01339247|O1|Outcome|Test Product|Test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods
267310|NCT01339247|E2|Reported Event|Period 2|Participants receiving test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2
267311|NCT01339247|E1|Reported Event|Period 1|Participants receiving test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 1
267312|NCT01339091|B3|Baseline|Total|Total of all reporting groups
267313|NCT01339091|B2|Baseline|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
267314|NCT01339091|B1|Baseline|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
267315|NCT01339091|P2|Participant Flow|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
267316|NCT01339091|P1|Participant Flow|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
267317|NCT01339091|O2|Outcome|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
267318|NCT01339091|O1|Outcome|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
267319|NCT01339091|O2|Outcome|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
267320|NCT01339091|O1|Outcome|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
267321|NCT01339091|O2|Outcome|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
267322|NCT01339091|O1|Outcome|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
267323|NCT01339091|O2|Outcome|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
267324|NCT01339091|O1|Outcome|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
267325|NCT01339091|E2|Reported Event|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
267326|NCT01339091|E1|Reported Event|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
267327|NCT01339052|B3|Baseline|Total|Total of all reporting groups
267328|NCT01339052|B2|Baseline|Cohort 2: Non-surgical Subjects|"Subjects not candidates for surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
267329|NCT01339052|B1|Baseline|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
267330|NCT01339052|P2|Participant Flow|Cohort 2: Non-surgical Subjects|"Subjects not candidates for surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
267331|NCT01339052|P1|Participant Flow|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
267332|NCT01339052|O2|Outcome|Cohorts 2: Non-surgical Subjects|"Subjects not candidates for surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Patients continued treatment until disease progression or unacceptable toxicity."
267333|NCT01339052|O1|Outcome|Cohorts 1: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Patients continued treatment until disease progression or unacceptable toxicity."
267334|NCT01339052|O1|Outcome|Cohort 2: Non-surgical Subjects|"Subjects not candidates for surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
267335|NCT01339052|O1|Outcome|Cohort 2: Non-surgical Subjects|"Subjects not candidates for surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
267336|NCT01339052|O1|Outcome|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
267337|NCT01339052|O1|Outcome|Cohort I: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
267338|NCT01339052|O1|Outcome|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
267339|NCT01339052|O1|Outcome|Cohort I: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
267340|NCT01339052|O1|Outcome|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
267341|NCT01339052|O1|Outcome|Cohort 2: Non-surgical Subjects|"Subjects not candidates for surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
267342|NCT01339052|O1|Outcome|Cohort I: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
267343|NCT01339052|O1|Outcome|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
267344|NCT01339052|O1|Outcome|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
267345|NCT01339052|O1|Outcome|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
267346|NCT01339052|O1|Outcome|Cohort 2: Non-surgical Subjects|"Subjects not candidates for surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
267347|NCT01339052|O1|Outcome|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
267348|NCT01339052|E2|Reported Event|Cohorts 2: Non-surgical Subjects|"Subjects not candidates for surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Patients continued treatment until disease progression or unacceptable toxicity."
267349|NCT01339052|E1|Reported Event|Cohorts 1: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Patients continued treatment until disease progression or unacceptable toxicity."
267350|NCT01339013|B1|Baseline|All Study Participants|Heat and Moisture Exchanger, then AnaConDa, finally Heat and Moisture Exchanger
267351|NCT01339013|P1|Participant Flow|AnaConDa Replaces the Heat and Moisture Exchanger|The conventional Heat and Moisture Exchanger is replaced by the AnaConDa which in turn is replaced by the conventional Heat and Moisture Exchanger.
267352|NCT01339013|O1|Outcome|AnaConDa|Anesthetic Conserving Device (AnaConDa) has a charcoal filter.
267353|NCT01339013|E1|Reported Event|AnaConDa|Anesthetic Conserving Device (AnaConDa or ACD) has a charcoal filter.
267354|NCT01339000|B3|Baseline|Total|Total of all reporting groups
267355|NCT01339000|B2|Baseline|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
267377|NCT01338870|B1|Baseline|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267356|NCT01339000|B1|Baseline|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
267357|NCT01339000|P2|Participant Flow|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
267358|NCT01339000|P1|Participant Flow|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
267359|NCT01339000|O2|Outcome|Arm B - Sequence Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
267360|NCT01339000|O1|Outcome|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
267361|NCT01339000|O2|Outcome|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
267362|NCT01339000|O1|Outcome|Arm A - Sequence 1 Immunizationa|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
267363|NCT01339000|O2|Outcome|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
267378|NCT01338870|P6|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267379|NCT01338870|P5|Participant Flow|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267950|NCT01336647|P1|Participant Flow|Low Dose Ha 44 Gel|Low-Dose Ha44 Gel 0.37%, it was administered topically for 10 minutes as a single dose.
267364|NCT01339000|O1|Outcome|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
267365|NCT01339000|O2|Outcome|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
267366|NCT01339000|O1|Outcome|Arm A -Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
267367|NCT01339000|O2|Outcome|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
267368|NCT01339000|O1|Outcome|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
267369|NCT01339000|E2|Reported Event|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
267370|NCT01339000|E1|Reported Event|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
267371|NCT01338870|B7|Baseline|Total|Total of all reporting groups
267372|NCT01338870|B6|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267373|NCT01338870|B5|Baseline|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267374|NCT01338870|B4|Baseline|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267375|NCT01338870|B3|Baseline|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267376|NCT01338870|B2|Baseline|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267951|NCT01336647|O3|Outcome|Vehicle|Vehicle Gel without active ingredient administered topically to hair and scalp for 10 minutes.
267380|NCT01338870|P4|Participant Flow|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267381|NCT01338870|P3|Participant Flow|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267382|NCT01338870|P2|Participant Flow|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267383|NCT01338870|P1|Participant Flow|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267384|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267385|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267386|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267387|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267388|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267389|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267390|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267391|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267392|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267393|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267394|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267395|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267396|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267397|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267398|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267399|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267400|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267401|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267402|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267403|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267404|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267405|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267406|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267407|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267408|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267409|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267410|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267411|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267412|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267413|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267414|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267415|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267416|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267417|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267418|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267419|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267420|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267421|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267422|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267423|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267424|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267425|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267426|NCT01338870|E6|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267427|NCT01338870|E5|Reported Event|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267428|NCT01338870|E4|Reported Event|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267429|NCT01338870|E3|Reported Event|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267430|NCT01338870|E2|Reported Event|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267454|NCT01338649|O2|Outcome|Dim Red Light|"Dim red light control group.~Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using"
289216|NCT01274897|B3|Baseline|Total|Total of all reporting groups
267431|NCT01338870|E1|Reported Event|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267432|NCT01338857|B1|Baseline|Sorafenib (Nexavar)|"Sorafenib will be administered orally BID (approximately every 12 hours). A cycle is 28 days w/o interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met.~Children/adolescents (< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment) to a maximum of 400 mg PO twice daily~Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily~NF1 patients: 80mg/m2/dose PO 2x daily to max of 150mg PO 2x daily."
267433|NCT01338857|P1|Participant Flow|Sorafenib (Nexavar)|"Sorafenib will be administered orally BID (approximately every 12 hours). A cycle is 28 days w/o interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met.~Children/adolescents (< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment) to a maximum of 400 mg PO twice daily~Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily~NF1 patients: 80mg/m2/dose PO 2x daily to max of 150mg PO 2x daily."
267434|NCT01338857|O1|Outcome|Sorafenib (Nexavar)|"Sorafenib will be administered orally BID (approximately every 12 hours). A cycle is 28 days w/o interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met.~Children/adolescents (< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment) to a maximum of 400 mg PO twice daily~Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily~NF1 patients: 80mg/m2/dose PO 2x daily to max of 150mg PO 2x daily."
267435|NCT01338857|O1|Outcome|Sorafenib (Nexavar)|"Sorafenib will be administered orally BID (approximately every 12 hours). A cycle is 28 days w/o interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met.~Children/adolescents (< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment) to a maximum of 400 mg PO twice daily~Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily~NF1 patients: 80mg/m2/dose PO 2x daily to max of 150mg PO 2x daily."
267436|NCT01338857|E1|Reported Event|Sorafenib (Nexavar)|"Sorafenib will be administered orally BID (approximately every 12 hours). A cycle is 28 days w/o interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met.~Children/adolescents (< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment) to a maximum of 400 mg PO twice daily~Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily~NF1 patients: 80mg/m2/dose PO 2x daily to max of 150mg PO 2x daily."
267437|NCT01338818|B1|Baseline|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40, 60 or 80 mg/day).
267438|NCT01338818|P1|Participant Flow|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40, 60 or 80 mg/day).
267439|NCT01338818|O1|Outcome|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40, 60 or 80 mg/day).
267440|NCT01338818|O1|Outcome|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40, 60 or 80 mg/day).
267441|NCT01338818|O1|Outcome|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40, 60 or 80 mg/day).
267442|NCT01338818|E1|Reported Event|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40, 60 or 80 mg/day).
267443|NCT01338792|B1|Baseline|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
267444|NCT01338792|P1|Participant Flow|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
267445|NCT01338792|O1|Outcome|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
267446|NCT01338792|O1|Outcome|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
267447|NCT01338792|O1|Outcome|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
267448|NCT01338792|E1|Reported Event|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
267449|NCT01338649|B3|Baseline|Total|Total of all reporting groups
267450|NCT01338649|B2|Baseline|Dim Red Light|"Dim red light control group.~Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using"
267451|NCT01338649|B1|Baseline|Bright White|"Bright white light treatment group.~Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day."
267452|NCT01338649|P2|Participant Flow|Dim Red Light|"Dim red light control group.~Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using"
267453|NCT01338649|P1|Participant Flow|Bright White|"Bright white light treatment group.~Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day."
267952|NCT01336647|O2|Outcome|High Dose Ha44|High-Dose Ha44 0.74% Gel administered topically to hair and scalp for 10 minutes.
267455|NCT01338649|O1|Outcome|Bright White|"Bright white light treatment group.~Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day."
267456|NCT01338649|E2|Reported Event|Dim Red Light|"Dim red light control group.~Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using"
267457|NCT01338649|E1|Reported Event|Bright White|"Bright white light treatment group.~Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day."
267458|NCT01338636|B1|Baseline|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
267459|NCT01338636|P1|Participant Flow|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
267460|NCT01338636|O1|Outcome|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
267461|NCT01338636|O1|Outcome|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
267462|NCT01338636|O1|Outcome|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
267463|NCT01338636|O1|Outcome|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
267464|NCT01338636|O1|Outcome|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
267465|NCT01338636|O1|Outcome|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
267466|NCT01338636|O1|Outcome|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
267467|NCT01338636|O1|Outcome|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
267468|NCT01338636|E1|Reported Event|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
267469|NCT01338610|B4|Baseline|Total|Total of all reporting groups
267470|NCT01338610|B3|Baseline|Vehicle|ESBA105 vehicle (Run-In), ESBA105 vehicle (treatment)
267471|NCT01338610|B2|Baseline|ESBA105|ESBA 105 vehicle (Run-In), ESBA105 ophthalmic solution (treatment)
267472|NCT01338610|B1|Baseline|Run-In Only|ESBA105 vehicle
267473|NCT01338610|P3|Participant Flow|Vehicle|ESBA105 vehicle (Run-In), ESBA105 vehicle (treatment)
267474|NCT01338610|P2|Participant Flow|ESBA105|ESBA105 vehicle (Run-In), ESBA105 ophthalmic solution (treatment)
267475|NCT01338610|P1|Participant Flow|Run-In Only|ESBA105 vehicle
267476|NCT01338610|O2|Outcome|Vehicle|ESBA105 vehicle
267477|NCT01338610|O1|Outcome|ESBA105|ESBA105 ophthalmic solution
267478|NCT01338610|E3|Reported Event|Vehicle|ESBA105 vehicle
267479|NCT01338610|E2|Reported Event|ESBA105|ESBA105 ophthalmic solution
267480|NCT01338610|E1|Reported Event|Run-In|ESBA105 vehicle, all participants
267481|NCT01338493|B1|Baseline|Lumbar Spinal Arthroplasty + Maverick™|"Patients requiring total disc replacement~lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc."
267482|NCT01338493|P1|Participant Flow|Lumbar Spinal Arthroplasty + Maverick™|"Patients requiring total disc replacement~lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc."
267483|NCT01338493|O1|Outcome|Lumbar Spinal Arthroplasty + Maverick™|"Patients requiring total disc replacement~lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc."
267484|NCT01338493|O1|Outcome|Lumbar Spinal Arthroplasty + Maverick™|"Patients requiring total disc replacement~lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc."
267485|NCT01338493|E1|Reported Event|Lumbar Spinal Arthroplasty + Maverick™|"Patients requiring total disc replacement~lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc."
267486|NCT01338415|B3|Baseline|Total|Total of all reporting groups
267487|NCT01338415|B2|Baseline|Bosentan 2mg/kg t.i.d.|Patients received 2 mg/kg bosentan t.i.d. during the FUTURE 3 core study and continued with the same dose regimen during the extension study
267488|NCT01338415|B1|Baseline|Bosentan 2mg/kg b.i.d.|Patients received 2 mg/kg bosentan b.i.d. during the FUTURE 3 core study and continued with the same dose regimen during the extension study
268236|NCT01335789|P1|Participant Flow|Oxytocin|"intranasal administration~Oxytocin: 40 IUs"
267489|NCT01338415|P2|Participant Flow|Bosentan 2mg/kg t.i.d.|Patients received 2 mg/kg bosentan 3 times a day (t.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study
267490|NCT01338415|P1|Participant Flow|Bosentan 2mg/kg b.i.d.|Patients received 2 mg/kg bosentan twcie daily (b.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study
267491|NCT01338415|O2|Outcome|Bosentan 2mg/kg t.i.d.|Patients received 2 mg/kg bosentan 3 times a day (t.i.d.) during the FUTURE 3 core study continued with the same dose regimen during the extension study
267492|NCT01338415|O1|Outcome|Bosentan 2mg/kg b.i.d.|Patients received 2 mg/kg bosentan twice daily (b.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study
267493|NCT01338415|O2|Outcome|Bosentan 2mg/kg t.i.d.|Patients received 2 mg/kg bosentan 3 times a day (t.i.d.) during the FUTURE 3 core study continued with the same dose regimen during the extension study
267494|NCT01338415|O1|Outcome|Bosentan 2mg/kg b.i.d.|Patients received 2 mg/kg bosentan twice daily (b.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study
267495|NCT01338415|O2|Outcome|Bosentan 2mg/kg t.i.d.|Patients received 2 mg/kg bosentan 3 times a day (t.i.d.) during the FUTURE 3 core study continued with the same dose regimen during the extension study
267496|NCT01338415|O1|Outcome|Bosentan 2mg/kg b.i.d.|Patients received 2 mg/kg bosentan twice daily (b.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study
267497|NCT01338415|O2|Outcome|Bosentan 2mg/kg t.i.d.|Patients received 2 mg/kg bosentan 3 times a day (t.i.d.) during the FUTURE 3 core study continued with the same dose regimen during the extension study
267498|NCT01338415|O1|Outcome|Bosentan 2mg/kg b.i.d.|Patients received 2 mg/kg bosentan twice daily (b.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study
267499|NCT01338415|O2|Outcome|Bosentan 2mg/kg t.i.d.|Patients received 2 mg/kg bosentan 3 times a day (t.i.d.) during the FUTURE 3 core study continued with the same dose regimen during the extension study
267500|NCT01338415|O1|Outcome|Bosentan 2mg/kg b.i.d.|Patients received 2 mg/kg bosentan twice daily (b.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study
267501|NCT01338415|O2|Outcome|Bosentan 2mg/kg t.i.d.|Patients received 2 mg/kg bosentan 3 times a day (t.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study
267502|NCT01338415|O1|Outcome|Bosentan 2mg/kg b.i.d.|Patients received 2 mg/kg bosentan twcie daily (b.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study
267503|NCT01338415|O2|Outcome|Bosentan 2mg/kg t.i.d.|Patients received 2 mg/kg bosentan 3 times a day (t.i.d.) during the FUTURE 3 core study continued with the same dose regimen during the extension study
267504|NCT01338415|O1|Outcome|Bosentan 2mg/kg b.i.d.|Patients received 2 mg/kg bosentan twice daily (b.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study
267505|NCT01338415|O2|Outcome|Bosentan 2mg/kg t.i.d.|Patients received 2 mg/kg bosentan 3 times a day (t.i.d.) during the FUTURE 3 core study continued with the same dose regimen during the extension study
267506|NCT01338415|O1|Outcome|Bosentan 2mg/kg b.i.d.|Patients received 2 mg/kg bosentan twice daily (b.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study
267507|NCT01338415|E2|Reported Event|Bosentan 2mg/kg t.i.d|2 mg/kg bosentan was administered 3 times a day for a cumulative mean (± SD) duration of 60.4 ± 4.20 weeks (FUTURE 3 core + extension studies)
267508|NCT01338415|E1|Reported Event|Bosentan 2mg/kg b.i.d.|2 mg/kg bosentan was administered twice daily for a cumulative mean (± SD) duration of 64.1 ± 3.38 weeks (FUTURE 3 core + extension studies)
267509|NCT01338298|B3|Baseline|Total|Total of all reporting groups
267510|NCT01338298|B2|Baseline|Placebo|Placebo: The placebo will be sucrose filled capsules that are identical to the active medication. It is double blind so no one will know if the capsule is placebo or aripiprazole.
267511|NCT01338298|B1|Baseline|Aripiprazole|Aripiprazole: Aripiprazole dosing will begin at 5 mg/day once daily and increased to 10mg by mouth once daily at the end of week 2 and then increased to 15 mg/day once daily at the end of week 8 in women who have not yet regained their menstrual period. If a woman gets her menstrual period on the 5 or 10 mg dose she will remain on this dose for the study.
267512|NCT01338298|P2|Participant Flow|Placebo|Placebo: The placebo will be sucrose filled capsules that are identical to the active medication. It is double blind so no one will know if the capsule is placebo or aripiprazole.
267513|NCT01338298|P1|Participant Flow|Aripiprazole|Aripiprazole: Aripiprazole dosing will begin at 5 mg/day once daily and increased to 10mg by mouth once daily at the end of week 2 and then increased to 15 mg/day once daily at the end of week 8 in women who have not yet regained their menstrual period. If a woman gets her menstrual period on the 5 or 10 mg dose she will remain on this dose for the study.
267514|NCT01338298|O2|Outcome|Placebo|Placebo: The placebo will be sucrose filled capsules that are identical to the active medication. It is double blind so no one will know if the capsule is placebo or aripiprazole.
267515|NCT01338298|O1|Outcome|Aripiprazole|Aripiprazole: Aripiprazole dosing will begin at 5 mg/day once daily and increased to 10mg by mouth once daily at the end of week 2 and then increased to 15 mg/day once daily at the end of week 8 in women who have not yet regained their menstrual period. If a woman gets her menstrual period on the 5 or 10 mg dose she will remain on this dose for the study.
267516|NCT01338298|O2|Outcome|Placebo|Placebo: The placebo will be sucrose filled capsules that are identical to the active medication. It is double blind so no one will know if the capsule is placebo or aripiprazole.
267517|NCT01338298|O1|Outcome|Aripiprazole|Aripiprazole: Aripiprazole dosing will begin at 5 mg/day once daily and increased to 10mg by mouth once daily at the end of week 2 and then increased to 15 mg/day once daily at the end of week 8 in women who have not yet regained their menstrual period. If a woman gets her menstrual period on the 5 or 10 mg dose she will remain on this dose for the study.
267518|NCT01338298|E2|Reported Event|Placebo|Placebo: The placebo will be sucrose filled capsules that are identical to the active medication. It is double blind so no one will know if the capsule is placebo or aripiprazole.
267953|NCT01336647|O1|Outcome|Low Dose Ha44|Low-Dose Ha44 0.37% Gel, administered topically to hair and scalp for 10 minutes.
267519|NCT01338298|E1|Reported Event|Aripiprazole|Aripiprazole: Aripiprazole dosing will begin at 5 mg/day once daily and increased to 10mg by mouth once daily at the end of week 2 and then increased to 15 mg/day once daily at the end of week 8 in women who have not yet regained their menstrual period. If a woman gets her menstrual period on the 5 or 10 mg dose she will remain on this dose for the study.
267520|NCT01338025|B3|Baseline|Total|Total of all reporting groups
267521|NCT01338025|B2|Baseline|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider."
267522|NCT01338025|B1|Baseline|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen as prescribed by their primary provider.~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider."
267523|NCT01338025|P2|Participant Flow|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects were randomized to receive 3TC or FTC (the choice of 3TC or FTC was left to the provider.) In Step 2, subjects either began a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~3TC or FTC monotherapy: The study participant was assigned to either 3TC or FTC monotherapy (the choice of 3TC or FTC was left to the provider.)"
267524|NCT01338025|P1|Participant Flow|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects were randomized to continue their non-suppressive HAART regimen.~In Step 2, subjects either began a new HAART regimen, continue randomized treatment, or discontinued therapy while remaining on follow-up, as decided by their provider.~HAART regimen: The study participant continued their non-suppressive HAART regimen as prescribed by their primary provider."
267525|NCT01338025|O2|Outcome|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~3TC or FTC monotherapy: The study participant will be assigned to either 3TC/FTC monotherapy (the choice of 3TC or FTC will be left to the provider."
267526|NCT01338025|O1|Outcome|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen.~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~HAART regimen: The study participant will continue their non-suppressive HAART regimen as prescribed by their primary provider."
267527|NCT01338025|O2|Outcome|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~3TC or FTC monotherapy: The study participant will be assigned to either 3TC/FTC monotherapy (the choice of 3TC or FTC will be left to the provider."
267528|NCT01338025|O1|Outcome|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen.~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~HAART regimen: The study participant will continue their non-suppressive HAART regimen as prescribed by their primary provider."
267529|NCT01338025|O2|Outcome|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~3TC or FTC monotherapy: The study participant will be assigned to either 3TC/FTC monotherapy (the choice of 3TC or FTC will be left to the provider."
267530|NCT01338025|O1|Outcome|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen.~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~HAART regimen: The study participant will continue their non-suppressive HAART regimen as prescribed by their primary provider."
267531|NCT01338025|O2|Outcome|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~3TC or FTC monotherapy: The study participant will be assigned to either 3TC/FTC monotherapy (the choice of 3TC or FTC will be left to the provider."
267532|NCT01338025|O1|Outcome|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen.~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~HAART regimen: The study participant will continue their non-suppressive HAART regimen as prescribed by their primary provider."
267533|NCT01338025|E2|Reported Event|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider."
267534|NCT01338025|E1|Reported Event|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen as prescribed by their primary provider.~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider."
267535|NCT01338012|B1|Baseline|Sipuleucel-T|Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions.
267536|NCT01338012|P1|Participant Flow|Sipuleucel-T|Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions.
267598|NCT01337635|B1|Baseline|Standard Dose Vitamin D|"Treatment with cholecalciferol 400 IU daily at home.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
267537|NCT01338012|O1|Outcome|Sipuleucel-T|Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions.
267538|NCT01338012|E1|Reported Event|Sipuleucel-T|Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions.
267539|NCT01337960|B4|Baseline|Total|Total of all reporting groups
267540|NCT01337960|B3|Baseline|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
267541|NCT01337960|B2|Baseline|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
267542|NCT01337960|B1|Baseline|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
267543|NCT01337960|P3|Participant Flow|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
267544|NCT01337960|P2|Participant Flow|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
267545|NCT01337960|P1|Participant Flow|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
267546|NCT01337960|O3|Outcome|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
267593|NCT01337674|E3|Reported Event|Panel B: MK-4618 + Amlo|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
267594|NCT01337674|E2|Reported Event|Panel A: PBO + Met|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
289921|NCT01272583|O2|Outcome|Sitagliptin Treatment|
267547|NCT01337960|O2|Outcome|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
267548|NCT01337960|O1|Outcome|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
267549|NCT01337960|O3|Outcome|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
267550|NCT01337960|O2|Outcome|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
267551|NCT01337960|O1|Outcome|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
267552|NCT01337960|O3|Outcome|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
267553|NCT01337960|O2|Outcome|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
267554|NCT01337960|O1|Outcome|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
267595|NCT01337674|E1|Reported Event|Panel A: MK-4618 + Met|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
267596|NCT01337635|B3|Baseline|Total|Total of all reporting groups
267644|NCT01337336|E1|Reported Event|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
267555|NCT01337960|O3|Outcome|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
267556|NCT01337960|O2|Outcome|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
267557|NCT01337960|O1|Outcome|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
267558|NCT01337960|O3|Outcome|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
267559|NCT01337960|O2|Outcome|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
267560|NCT01337960|O1|Outcome|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
267561|NCT01337960|E3|Reported Event|Trll Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
267562|NCT01337960|E2|Reported Event|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
267597|NCT01337635|B2|Baseline|High Dose Vitamin D|"Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
267645|NCT01337297|B3|Baseline|Total|Total of all reporting groups
289922|NCT01272583|O1|Outcome|Baseline|
267563|NCT01337960|E1|Reported Event|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
267564|NCT01337739|B3|Baseline|Total|Total of all reporting groups
267565|NCT01337739|B2|Baseline|Active Comparator|Administration of Dexmedetomidine
267566|NCT01337739|B1|Baseline|Placebo Comparator|Continuous infusion of placebo during operative procedure
267567|NCT01337739|P2|Participant Flow|Active Comparator|Administration of Dexmedetomidine
267568|NCT01337739|P1|Participant Flow|Placebo Comparator|Continuous infusion of placebo during operative procedure
267569|NCT01337739|O2|Outcome|Active Comparator|Administration of Dexmedetomidine
267570|NCT01337739|O1|Outcome|Placebo Comparator|Continuous infusion of placebo during operative procedure
267571|NCT01337739|O2|Outcome|Active Comparator|Administration of Dexmedetomidine
267572|NCT01337739|O1|Outcome|Placebo Comparator|Continuous infusion of placebo during operative procedure
267573|NCT01337739|E2|Reported Event|Active Comparator|Administration of Dexmedetomidine
267574|NCT01337739|E1|Reported Event|Placebo Comparator|Continuous infusion of placebo during operative procedure
267575|NCT01337674|B3|Baseline|Total|Total of all reporting groups
267576|NCT01337674|B2|Baseline|Panel B Participants|Once daily oral dose of MK-4618 (two 50-mg tablets) or placebo (two tablets) on Days 1 through 7 in Period 1 followed by the crossover treatment in Period 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
267577|NCT01337674|B1|Baseline|Panel A Participants|Once daily oral dose of MK-4618 (two 50-mg tablets) or placebo (two tablets) on Days 1 through 7 in Period 1 followed by the crossover treatment in Period 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
267578|NCT01337674|P4|Participant Flow|Panel B: PBO + Amlo → MK-4618 + Amlo|Once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 1 followed by MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of amlodipine (Amlo) for the duration of the study. A 2-week washout period follows Period 1.
267579|NCT01337674|P3|Participant Flow|Panel B: MK-4618 + Amlo → PBO + Amlo|Once daily oral dose of MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 1 followed by once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of amlodipine (Amlo) for the duration of the study. A 2-week washout period follows Period 1.
267580|NCT01337674|P2|Participant Flow|Panel A: PBO + Met → MK-4618 + Met|Once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 1 followed by MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of metoprolol (Met) for the duration of the study. A 2-week washout period follows Period 1.
267581|NCT01337674|P1|Participant Flow|Panel A: MK-4618 + Met → PBO + Met|Once daily oral dose of MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 1 followed by once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of metoprolol (Met) for the duration of the study. A 2-week washout period follows Period 1.
267582|NCT01337674|O2|Outcome|Panel B: MK-4618 + Amlo|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
267583|NCT01337674|O1|Outcome|Panel A: MK-4618 + Met|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
267584|NCT01337674|O2|Outcome|Panel B: PBO + Amlo|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
267585|NCT01337674|O1|Outcome|Panel B: MK-4618 + Amlo|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
267586|NCT01337674|O2|Outcome|Panel A: PBO + Met|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
267587|NCT01337674|O1|Outcome|Panel A: MK-4618 + Met|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
267588|NCT01337674|O4|Outcome|Panel B: PBO + Amlo|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
267589|NCT01337674|O3|Outcome|Panel B: MK-4618 + Amlo|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
267590|NCT01337674|O2|Outcome|Panel A: PBO + Met|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
267591|NCT01337674|O1|Outcome|Panel A: MK-4618 + Met|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
267592|NCT01337674|E4|Reported Event|Panel B: PBO + Amlo|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
267954|NCT01336647|O3|Outcome|Vehicle|Vehicle Gel without active ingredient administered topically to hair and scalp for 10 minutes.
267599|NCT01337635|P2|Participant Flow|High Dose Vitamin D|"Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
267600|NCT01337635|P1|Participant Flow|Standard Dose Vitamin D|"Treatment with cholecalciferol 400 IU daily at home.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
267601|NCT01337635|O2|Outcome|High Dose Vitamin D|"Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
267602|NCT01337635|O1|Outcome|Standard Dose Vitamin D|"Treatment with cholecalciferol 400 IU daily at home.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
267603|NCT01337635|E2|Reported Event|High Dose Vitamin D|"Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
267604|NCT01337635|E1|Reported Event|Standard Dose Vitamin D|"Treatment with cholecalciferol 400 IU daily at home.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
267605|NCT01337609|B4|Baseline|Total|Total of all reporting groups
267606|NCT01337609|B3|Baseline|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
267607|NCT01337609|B2|Baseline|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
267608|NCT01337609|B1|Baseline|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
267609|NCT01337609|P3|Participant Flow|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
267610|NCT01337609|P2|Participant Flow|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
267611|NCT01337609|P1|Participant Flow|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
267612|NCT01337609|O3|Outcome|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
267613|NCT01337609|O2|Outcome|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
267614|NCT01337609|O1|Outcome|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
267615|NCT01337609|O3|Outcome|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
267616|NCT01337609|O2|Outcome|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
267617|NCT01337609|O1|Outcome|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
267618|NCT01337609|O3|Outcome|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
267619|NCT01337609|O2|Outcome|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
267620|NCT01337609|O1|Outcome|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
267621|NCT01337609|O3|Outcome|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
267622|NCT01337609|O2|Outcome|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
267623|NCT01337609|O1|Outcome|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
267624|NCT01337609|O3|Outcome|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
267625|NCT01337609|O2|Outcome|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
267626|NCT01337609|O1|Outcome|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
267627|NCT01337609|E3|Reported Event|Placebo for 30 Days, Followed by GanedenBC30 for 30 Days|
267628|NCT01337609|E2|Reported Event|GanedenBC30 for 60 Days|
267629|NCT01337609|E1|Reported Event|Placebo for 60 Days|
267630|NCT01337336|B3|Baseline|Total|Total of all reporting groups
267631|NCT01337336|B2|Baseline|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
267632|NCT01337336|B1|Baseline|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
267633|NCT01337336|P2|Participant Flow|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
267634|NCT01337336|P1|Participant Flow|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
267635|NCT01337336|O2|Outcome|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
267636|NCT01337336|O1|Outcome|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
267637|NCT01337336|O2|Outcome|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
267638|NCT01337336|O1|Outcome|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
267639|NCT01337336|O2|Outcome|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
267640|NCT01337336|O1|Outcome|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
267641|NCT01337336|O2|Outcome|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
267642|NCT01337336|O1|Outcome|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
267643|NCT01337336|E2|Reported Event|AC Cohort|Anticholinergics (AC) include iotropium, and Ipratropium, Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
267646|NCT01337297|B2|Baseline|Sham-tDCS|"the electrodes are positioned in the same manner as the active-tDCS, activated for 20 s (time to climb ramp of the current until reach the current intensity used in the experiment), enough to produce the sensation of itch, and turned off until the end of the session.~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
267647|NCT01337297|B1|Baseline|Active-tDCS|"low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
267648|NCT01337297|P2|Participant Flow|Sham-tDCS|"the electrodes are positioned in the same manner as the active-tDCS, activated for 20 s (time to climb ramp of the current until reach the current intensity used in the experiment), enough to produce the sensation of itch, and turned off until the end of the session.~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
267649|NCT01337297|P1|Participant Flow|Active-tDCS|"low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
267650|NCT01337297|O2|Outcome|Sham-tDCS|"the electrodes are positioned in the same manner as the active-tDCS, activated for 20 s (time to climb ramp of the current until reach the current intensity used in the experiment), enough to produce the sensation of itch, and turned off until the end of the session.~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
267651|NCT01337297|O1|Outcome|Active-tDCS|"low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
267652|NCT01337297|E2|Reported Event|Sham-tDCS|"the electrodes are positioned in the same manner as the active-tDCS, activated for 20 s (time to climb ramp of the current until reach the current intensity used in the experiment), enough to produce the sensation of itch, and turned off until the end of the session.~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
267653|NCT01337297|E1|Reported Event|Active-tDCS|"low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
267654|NCT01337167|B3|Baseline|Total|Total of all reporting groups
267655|NCT01337167|B2|Baseline|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267656|NCT01337167|B1|Baseline|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267657|NCT01337167|P2|Participant Flow|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267658|NCT01337167|P1|Participant Flow|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267659|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267660|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267661|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267662|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267663|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
289923|NCT01272583|E3|Reported Event|Placebo|
267664|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267665|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267666|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267667|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267668|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267669|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267670|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267671|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267672|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267673|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267674|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267675|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267676|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267677|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267678|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267679|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267680|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267681|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267682|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267683|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267684|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267685|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267955|NCT01336647|O2|Outcome|Hig Dose Ha44|Ha44 0.74% Gel administered topically to hair and scalp for 10 minutes.
289924|NCT01272583|E2|Reported Event|Sitagliptin Treatment|
267686|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267687|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267688|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267689|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267690|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267691|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267692|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267693|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267694|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267695|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267696|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267697|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267698|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267699|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267700|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267701|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267702|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267703|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267704|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267705|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267706|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267707|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267956|NCT01336647|O1|Outcome|Low Dose Ha44|Ha44 0.37% Gel administered topically to hair and scalp for 10 minutes.
289925|NCT01272583|E1|Reported Event|Baseline|
267708|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267709|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267710|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267711|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267712|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267713|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267714|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267715|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267716|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267717|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267718|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267719|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267720|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267721|NCT01337167|E2|Reported Event|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267722|NCT01337167|E1|Reported Event|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
267723|NCT01337115|B3|Baseline|Total|Total of all reporting groups
267724|NCT01337115|B2|Baseline|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
267725|NCT01337115|B1|Baseline|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
267726|NCT01337115|P2|Participant Flow|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
267727|NCT01337115|P1|Participant Flow|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
267728|NCT01337115|O2|Outcome|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
267729|NCT01337115|O1|Outcome|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
267730|NCT01337115|O2|Outcome|CFNB+Single Shot SNB|Patients with additional sciatic nerve block
267731|NCT01337115|O1|Outcome|CFNB|Patients with continuous femoral nerve block
267732|NCT01337115|O2|Outcome|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
267759|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267733|NCT01337115|O1|Outcome|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
267734|NCT01337115|O2|Outcome|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
267735|NCT01337115|O1|Outcome|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
267736|NCT01337115|E2|Reported Event|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
267737|NCT01337115|E1|Reported Event|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
267738|NCT01337089|B1|Baseline|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 6 months. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
267739|NCT01337089|P1|Participant Flow|Nabiximols|Nabiximols was self-administered by participants as a 100 microliter (μL) oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 6 months. Nabiximols oromucosal spray contained delta-9-tetrahydrocannabinol (THC) (27 milligram [mg]/milliliter [mL]):cannabidiol (CBD) (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
267740|NCT01337089|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 6 months. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
267741|NCT01337089|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 6 months. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
267742|NCT01337089|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 6 months. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
267743|NCT01337089|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 6 months. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
267744|NCT01337089|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 6 months. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
267745|NCT01337089|E1|Reported Event|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 6 months. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
267746|NCT01337076|B1|Baseline|Implanted|Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation
267747|NCT01337076|P1|Participant Flow|Implanted|Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation
267748|NCT01337076|O1|Outcome|Implanted|Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation
267749|NCT01337076|E1|Reported Event|Implanted|Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation
267750|NCT01337050|B4|Baseline|Total|Total of all reporting groups
267751|NCT01337050|B3|Baseline|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267752|NCT01337050|B2|Baseline|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267753|NCT01337050|B1|Baseline|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267754|NCT01337050|P3|Participant Flow|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267755|NCT01337050|P2|Participant Flow|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267756|NCT01337050|P1|Participant Flow|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267757|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267758|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267760|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267761|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267762|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267763|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267764|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267765|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267766|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267767|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267768|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267769|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267770|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267771|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267772|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267773|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267774|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267775|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267776|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267777|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267778|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267779|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267780|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267781|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267782|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267783|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267784|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267785|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267786|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267787|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267788|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267789|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267790|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
268071|NCT01336413|B3|Baseline|Total|Total of all reporting groups
267791|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267792|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267793|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267794|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267795|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267796|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267797|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267798|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267799|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267800|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267801|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267802|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267803|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267804|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267805|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267806|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267807|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267808|NCT01337050|O1|Outcome|PF-03446962|PF-03446962 4.5, 7.0 or 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267809|NCT01337050|O1|Outcome|PF-03446962|PF-03446962 4.5, 7.0 or 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267810|NCT01337050|E3|Reported Event|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267811|NCT01337050|E2|Reported Event|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267812|NCT01337050|E1|Reported Event|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
267813|NCT01336972|B4|Baseline|Total|Total of all reporting groups
267814|NCT01336972|B3|Baseline|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267815|NCT01336972|B2|Baseline|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267816|NCT01336972|B1|Baseline|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267817|NCT01336972|P3|Participant Flow|eGFR <30 ml/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267818|NCT01336972|P2|Participant Flow|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267819|NCT01336972|P1|Participant Flow|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267820|NCT01336972|O3|Outcome|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267821|NCT01336972|O2|Outcome|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267945|NCT01336647|B3|Baseline|Vehicle|Vehicle Gel without active ingredient of Ha44.
267822|NCT01336972|O1|Outcome|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267823|NCT01336972|O3|Outcome|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267824|NCT01336972|O2|Outcome|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267825|NCT01336972|O1|Outcome|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267826|NCT01336972|O3|Outcome|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267827|NCT01336972|O2|Outcome|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267828|NCT01336972|O1|Outcome|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267829|NCT01336972|O3|Outcome|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267830|NCT01336972|O2|Outcome|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267831|NCT01336972|O1|Outcome|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267832|NCT01336972|O3|Outcome|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267833|NCT01336972|O2|Outcome|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267834|NCT01336972|O1|Outcome|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267835|NCT01336972|O3|Outcome|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267836|NCT01336972|O2|Outcome|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267837|NCT01336972|O1|Outcome|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267838|NCT01336972|O3|Outcome|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267839|NCT01336972|O2|Outcome|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267840|NCT01336972|O1|Outcome|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267841|NCT01336972|O3|Outcome|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267842|NCT01336972|O2|Outcome|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267843|NCT01336972|O1|Outcome|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267844|NCT01336972|O3|Outcome|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267845|NCT01336972|O2|Outcome|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267846|NCT01336972|O1|Outcome|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267847|NCT01336972|O3|Outcome|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability
267848|NCT01336972|O2|Outcome|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267849|NCT01336972|O1|Outcome|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267850|NCT01336972|E3|Reported Event|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267851|NCT01336972|E2|Reported Event|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
290462|NCT01271036|O1|Outcome|Male|Male Participants
267852|NCT01336972|E1|Reported Event|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
267853|NCT01336894|B3|Baseline|Total|Total of all reporting groups
267854|NCT01336894|B2|Baseline|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
267855|NCT01336894|B1|Baseline|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
267856|NCT01336894|P2|Participant Flow|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
267857|NCT01336894|P1|Participant Flow|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
267858|NCT01336894|O2|Outcome|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
267859|NCT01336894|O1|Outcome|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
267860|NCT01336894|O2|Outcome|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
267861|NCT01336894|O1|Outcome|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
267862|NCT01336894|O2|Outcome|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
267863|NCT01336894|O1|Outcome|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
267864|NCT01336894|O2|Outcome|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
267865|NCT01336894|O1|Outcome|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
267866|NCT01336894|O2|Outcome|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
267867|NCT01336894|O1|Outcome|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
267868|NCT01336894|O2|Outcome|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
267869|NCT01336894|O1|Outcome|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
267870|NCT01336894|O2|Outcome|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
267871|NCT01336894|O1|Outcome|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
267872|NCT01336894|E2|Reported Event|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
267873|NCT01336894|E1|Reported Event|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
267874|NCT01336764|B3|Baseline|Total|Total of all reporting groups
267875|NCT01336764|B2|Baseline|Control|"Coping self statements and breathing retraining will be replaced with undirected passive behaviors such as listening to music.~Control: Unguided listening to radio/music."
267876|NCT01336764|B1|Baseline|Active|"individual coping self-statements and stimulus guided paced breathing.~Cognitive reappraisal and breathing retraining: They will be induced to rapidly achieve reduced autonomic arousal through use of a graphics-rich biofeedback procedure and simultaneously engage in the generation and rehearsal of cognitive reappraisal scripts under the coaching of project therapist also in the vehicle."
267877|NCT01336764|P2|Participant Flow|Control|"Coping self statements and breathing retraining will be replaced with undirected passive behaviors such as listening to music.~Control: Unguided listening to radio/music."
267878|NCT01336764|P1|Participant Flow|Active|"individual coping self-statements and stimulus guided paced breathing.~Cognitive reappraisal and breathing retraining: They will be induced to rapidly achieve reduced autonomic arousal through use of a graphics-rich biofeedback procedure and simultaneously engage in the generation and rehearsal of cognitive reappraisal scripts under the coaching of project therapist also in the vehicle."
267879|NCT01336764|O2|Outcome|Control|"Coping self statements and breathing retraining will be replaced with undirected passive behaviors such as listening to music.~Control: Unguided listening to radio/music."
267880|NCT01336764|O1|Outcome|Active|"individual coping self-statements and stimulus guided paced breathing.~Cognitive reappraisal and breathing retraining: They will be induced to rapidly achieve reduced autonomic arousal through use of a graphics-rich biofeedback procedure and simultaneously engage in the generation and rehearsal of cognitive reappraisal scripts under the coaching of project therapist also in the vehicle."
267881|NCT01336764|E2|Reported Event|Control|"Coping self statements and breathing retraining will be replaced with undirected passive behaviors such as listening to music.~Control: Unguided listening to radio/music."
267882|NCT01336764|E1|Reported Event|Active|"individual coping self-statements and stimulus guided paced breathing.~Cognitive reappraisal and breathing retraining: They will be induced to rapidly achieve reduced autonomic arousal through use of a graphics-rich biofeedback procedure and simultaneously engage in the generation and rehearsal of cognitive reappraisal scripts under the coaching of project therapist also in the vehicle."
267883|NCT01336738|B6|Baseline|Total|Total of all reporting groups
267884|NCT01336738|B5|Baseline|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267885|NCT01336738|B4|Baseline|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267886|NCT01336738|B3|Baseline|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267887|NCT01336738|B2|Baseline|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267888|NCT01336738|B1|Baseline|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267889|NCT01336738|P5|Participant Flow|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267890|NCT01336738|P4|Participant Flow|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267891|NCT01336738|P3|Participant Flow|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267892|NCT01336738|P2|Participant Flow|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267893|NCT01336738|P1|Participant Flow|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267894|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267895|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267896|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267897|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267898|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267899|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267900|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267901|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267902|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267903|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267946|NCT01336647|B2|Baseline|High-Dose Ha44|High-Dose Ha44 0.74% Gel, topically administered to hair and scalp for 10 minutes
268072|NCT01336413|B2|Baseline|Placebo|Placebo: Same as active comparator, except placebo dispensed.
267904|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267905|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267906|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267907|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267908|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267909|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267910|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267911|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267912|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267913|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267914|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267915|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267916|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267917|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267918|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267919|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267920|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267921|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267922|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267923|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267947|NCT01336647|B1|Baseline|Low Dose Ha44 Gel|Low-Dose Ha44 0.37% Gel, topically administered to hair and scalp for 10 minutes
267948|NCT01336647|P3|Participant Flow|Vehicle|Vehicle Ha44 Gel with no active incident it was administered topically for 10 minutes as a single dose.
267924|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267925|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267926|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267927|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267928|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267929|NCT01336738|E5|Reported Event|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267930|NCT01336738|E4|Reported Event|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267931|NCT01336738|E3|Reported Event|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267932|NCT01336738|E2|Reported Event|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267933|NCT01336738|E1|Reported Event|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
267934|NCT01336712|B1|Baseline|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
267935|NCT01336712|P1|Participant Flow|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m^2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4~Patient follow up x6 months"
267936|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
267937|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
267938|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
267939|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
267940|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
267941|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
267942|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
267943|NCT01336712|E1|Reported Event|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
267944|NCT01336647|B4|Baseline|Total|Total of all reporting groups
267957|NCT01336647|E3|Reported Event|Vehicle|Vehicle Gel without active ingredient administered topically to hair and scalp for 10 minutes.
267958|NCT01336647|E2|Reported Event|High Dose Ha44 Gel|High-Dose Ha44 0.74% Gel, administered topically to hair and scalp for 10 minutes.
267959|NCT01336647|E1|Reported Event|Low Dose Ha44 Gel|Low-Dose Ha44 0.37% Gel, administered topically to hair and scalp for 10 minutes.
267960|NCT01336634|B4|Baseline|Total|Total of all reporting groups
267961|NCT01336634|B3|Baseline|Combination First-Line|Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given dabrafenib 150 mg BID and trametinib 2 mg OD. It was continued until disease progression or death or unacceptable AEs or at investigator discretion to discontinue.
267962|NCT01336634|B2|Baseline|Combination Second-Line Plus|Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received dabrafenib 150 mg BID and trametinib 2 mg once daily (OD). It was continued until disease progression or death or unacceptable AEs or investigator discretion to discontinue.
267963|NCT01336634|B1|Baseline|Monotherapy All Treated|Participants with or without prior systemic anti-cancer therapy received dabrafenib 150 mg BID. It was continued until disease progression or death or unacceptable adverse event(s) (AEs) or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
267964|NCT01336634|P3|Participant Flow|Combination First-Line|Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given dabrafenib 150 mg BID and trametinib 2 mg OD. It was continued until disease progression or death or unacceptable AEs or at investigator discretion to discontinue.
267965|NCT01336634|P2|Participant Flow|Combination Second-Line Plus|Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received dabrafenib 150 mg BID and trametinib 2 mg once daily (OD). It was continued until disease progression or death or unacceptable AEs or investigator discretion to discontinue.
267966|NCT01336634|P1|Participant Flow|Monotherapy All Treated|Participants with or without prior systemic anti-cancer therapy received dabrafenib 150 mg BID. It was continued until disease progression or death or unacceptable adverse event(s) (AEs) or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
267967|NCT01336634|O3|Outcome|Combination First-Line|Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given dabrafenib 150 mg BID and trametinib 2 mg OD. It was continued until disease progression or death or unacceptable AEs or at investigator discretion to discontinue.
267968|NCT01336634|O2|Outcome|Combination Second-Line Plus|Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received dabrafenib 150 mg BID and trametinib 2 mg once daily (OD). It was continued until disease progression or death or unacceptable AEs or investigator discretion to discontinue.
267969|NCT01336634|O1|Outcome|Monotherapy All Treated|Participants with or without prior systemic anti-cancer therapy received dabrafenib 150 mg BID. It was continued until disease progression or death or unacceptable adverse event(s) (AEs) or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
267970|NCT01336634|O3|Outcome|Combination First-Line|Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given dabrafenib 150 mg BID and trametinib 2 mg OD. It was continued until disease progression or death or unacceptable AEs or at investigator discretion to discontinue
267971|NCT01336634|O2|Outcome|Combination Second-Line Plus|Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received dabrafenib 150 mg BID and trametinib 2 mg once daily (OD). It was continued until disease progression or death or unacceptable AEs or investigator discretion to discontinue.
267972|NCT01336634|O1|Outcome|Monotherapy All Treated|Participants with or without prior systemic anti-cancer therapy received dabrafenib 150 mg BID. It was continued until disease progression or death or unacceptable adverse event(s) (AEs) or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
267973|NCT01336634|O3|Outcome|Combination First-Line|Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given dabrafenib 150 mg BID and trametinib 2 mg OD. It was continued until disease progression or death or unacceptable AEs or at investigator discretion to discontinue.
267974|NCT01336634|O2|Outcome|Combination Second-Line Plus|Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received dabrafenib 150 mg BID and trametinib 2 mg once daily (OD). It was continued until disease progression or death or unacceptable AEs or investigator discretion to discontinue.
267975|NCT01336634|O1|Outcome|Monotherapy All Treated|Participants with or without prior systemic anti-cancer therapy received dabrafenib 150 mg BID. It was continued until disease progression or death or unacceptable adverse event(s) (AEs) or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
267976|NCT01336634|O3|Outcome|Combination First-Line|Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given dabrafenib 150 mg BID and trametinib 2 mg OD. It was continued until disease progression or death or unacceptable AEs or at investigator discretion to discontinue.
267977|NCT01336634|O2|Outcome|Combination Second-Line Plus|Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received dabrafenib 150 mg BID and trametinib 2 mg once daily (OD). It was continued until disease progression or death or unacceptable AEs or investigator discretion to discontinue.
267978|NCT01336634|O1|Outcome|Monotherapy All Treated|Participants with or without prior systemic anti-cancer therapy received dabrafenib 150 mg BID. It was continued until disease progression or death or unacceptable adverse event(s) (AEs) or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
267979|NCT01336634|O3|Outcome|Combination First-Line|Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given dabrafenib 150 mg BID and trametinib 2 mg OD. It was continued until disease progression or death or unacceptable AEs or at investigator discretion to discontinue.
267980|NCT01336634|O2|Outcome|Combination Second-Line Plus|Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received dabrafenib 150 mg BID and trametinib 2 mg once daily (OD). It was continued until disease progression or death or unacceptable AEs or investigator discretion to discontinue.
267981|NCT01336634|O1|Outcome|Monotherapy All Treated|Participants with or without prior systemic anti-cancer therapy received dabrafenib 150 mg BID. It was continued until disease progression or death or unacceptable adverse event(s) (AEs) or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
267982|NCT01336634|O3|Outcome|Combination First-Line|Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given dabrafenib 150 mg BID and trametinib 2 mg OD. It was continued until disease progression or death or unacceptable AEs or at investigator discretion to discontinue.
267983|NCT01336634|O2|Outcome|Combination Second-Line Plus|Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received dabrafenib 150 mg BID and trametinib 2 mg once daily (OD). It was continued until disease progression or death or unacceptable AEs or investigator discretion to discontinue.
267984|NCT01336634|O1|Outcome|Monotherapy All Treated|Participants with or without prior systemic anti-cancer therapy received dabrafenib 150 mg BID. It was continued until disease progression or death or unacceptable adverse event(s) (AEs) or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
267985|NCT01336634|O3|Outcome|Combination First-Line|Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given dabrafenib 150 mg BID and trametinib 2 mg OD. It was continued until disease progression or death or unacceptable AEs or at investigator discretion to discontinue.
267986|NCT01336634|O2|Outcome|Combination Second-Line Plus|Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received dabrafenib 150 mg BID and trametinib 2 mg once daily (OD). It was continued until disease progression or death or unacceptable AEs or investigator discretion to discontinue.
267987|NCT01336634|O1|Outcome|Monotherapy All Treated|Participants with or without prior systemic anti-cancer therapy received dabrafenib 150 mg BID. It was continued until disease progression or death or unacceptable adverse event(s) (AEs) or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
267988|NCT01336634|O3|Outcome|Combination First-Line|Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given dabrafenib 150 mg BID and trametinib 2 mg OD. It was continued until disease progression or death or unacceptable AEs or at investigator discretion to discontinue.
267989|NCT01336634|O2|Outcome|Combination Second-Line Plus|Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received dabrafenib 150 mg BID and trametinib 2 mg once daily (OD). It was continued until disease progression or death or unacceptable AEs or investigator discretion to discontinue.
267990|NCT01336634|O1|Outcome|Monotherapy All Treated|Participants with or without prior systemic anti-cancer therapy received dabrafenib 150 mg BID. It was continued until disease progression or death or unacceptable adverse event(s) (AEs) or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
267991|NCT01336634|O3|Outcome|Combination First-Line|Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given dabrafenib 150 mg BID and trametinib 2 mg OD. It was continued until disease progression or death or unacceptable AEs or at investigator discretion to discontinue.
267992|NCT01336634|O2|Outcome|Combination Second-Line Plus|Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received dabrafenib 150 mg BID and trametinib 2 mg once daily (OD). It was continued until disease progression or death or unacceptable AEs or investigator discretion to discontinue.
267993|NCT01336634|O1|Outcome|Monotherapy Second-Line Plus|Participants who have relapsed or progressed after receiving at least one line of prior anti-cancer therapy for metastatic disease received dabrafenib 150 mg BID. It was continued until disease progression or death or unacceptable AEs or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
267994|NCT01336634|O3|Outcome|Combination First-Line|Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given dabrafenib 150 mg BID and trametinib 2 mg OD. It was continued until disease progression or death or unacceptable AEs or at investigator discretion to discontinue.
267995|NCT01336634|O2|Outcome|Combination Second-Line Plus|Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received dabrafenib 150 mg BID and trametinib 2 mg once daily (OD). It was continued until disease progression or death or unacceptable AEs or investigator discretion to discontinue.
267996|NCT01336634|O1|Outcome|Monotherapy Second-Line Plus|Participants who have relapsed or progressed after receiving at least one line of prior anti-cancer therapy for metastatic disease received dabrafenib 150 mg BID. It was continued until disease progression or death or unacceptable AEs or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
267997|NCT01336634|O3|Outcome|Combination First-Line|Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given dabrafenib 150 mg BID and trametinib 2 mg OD. It was continued until disease progression or death or unacceptable AEs or at investigator discretion to discontinue.
267998|NCT01336634|O2|Outcome|Combination Second-Line Plus|Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received dabrafenib 150 mg BID and trametinib 2 mg once daily (OD). It was continued until disease progression or death or unacceptable AEs or investigator discretion to discontinue
267999|NCT01336634|O1|Outcome|Monotherapy Second-Line Plus|Participants who have relapsed or progressed after receiving at least one line of prior anti-cancer therapy for metastatic disease received dabrafenib 150 mg BID. It was continued until disease progression or death or unacceptable AEs or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
268000|NCT01336634|O3|Outcome|Combination First-Line|Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given dabrafenib 150 mg BID and trametinib 2 mg OD. It was continued until disease progression or death or unacceptable AEs or at investigator discretion to discontinue.
268001|NCT01336634|O2|Outcome|Combination Second-Line Plus|Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received dabrafenib 150 mg BID and trametinib 2 mg once daily (OD). It was continued until disease progression or death or unacceptable AEs or investigator discretion to discontinue.
268237|NCT01335789|O2|Outcome|Saline|"intranasal administration~Saline: 40 IUs"
268002|NCT01336634|O1|Outcome|Monotherapy Second-Line Plus|Participants who have relapsed or progressed after receiving at least one line of prior anti-cancer therapy for metastatic disease received dabrafenib 150 mg BID. It was continued until disease progression or death or unacceptable AEs or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
268003|NCT01336634|E3|Reported Event|Combination First-Line|Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given dabrafenib 150 mg BID and trametinib 2 mg OD. It was continued until disease progression or death or unacceptable AEs or at investigator discretion to discontinue.
268004|NCT01336634|E2|Reported Event|Combination Second-Line Plus|Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received dabrafenib 150 mg BID and trametinib 2 mg once daily (OD). It was continued until disease progression or death or unacceptable AEs or investigator discretion to discontinue.
268005|NCT01336634|E1|Reported Event|Monotherapy All Treated|Participants with or without prior systemic anti-cancer therapy received dabrafenib 150 mg BID. It was continued until disease progression or death or unacceptable adverse event(s) (AEs) or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
268006|NCT01336621|B1|Baseline|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268007|NCT01336621|P1|Participant Flow|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268008|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268009|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268010|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268011|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268012|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268013|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268014|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268015|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268016|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268017|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268018|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268019|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268020|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268021|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268022|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268023|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268024|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268025|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268026|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268027|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268028|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268029|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268030|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268031|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268073|NCT01336413|B1|Baseline|Pregnenolone|Pregnenolone: Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
268074|NCT01336413|P2|Participant Flow|Placebo|Placebo: Same as active comparator, except placebo dispensed.
268032|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268033|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268034|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268035|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268036|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268037|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268038|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268039|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268040|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268041|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268042|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268043|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268044|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268045|NCT01336621|O1|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268075|NCT01336413|P1|Participant Flow|Pregnenolone|Pregnenolone: Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
268076|NCT01336413|O2|Outcome|Placebo|Placebo: Same as active comparator, except placebo dispensed.
268046|NCT01336621|E1|Reported Event|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
268047|NCT01336608|B4|Baseline|Total|Total of all reporting groups
268048|NCT01336608|B3|Baseline|FF/VI 100/25 µg QD|Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
268049|NCT01336608|B2|Baseline|VI 25 µg QD|Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
268050|NCT01336608|B1|Baseline|Placebo QD|Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
268051|NCT01336608|P4|Participant Flow|FF/VI 100/25 µg QD|Participants received fluticasone furoate (FF)/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
268052|NCT01336608|P3|Participant Flow|VI 25 µg QD|Participants received vilanterol (VI) 25 micrograms (µg) inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
268053|NCT01336608|P2|Participant Flow|Placebo QD|Participants received placebo QD in the morning via a dry powder inhaler (DPI) for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
268054|NCT01336608|P1|Participant Flow|Placebo-Run-in|Participants received placebo once daily (QD) in the morning for 2 weeks. In addition, participants were provided an inhaled short-acting beta2-receptor agonist (SABA), albuterol (salbutamol) (metered dose inhaler [MDI] or nebules), to be used as a rescue medication for relief of chronic obstructive pulmonary disease (COPD) symptoms during the Run-in and Treatment Periods.
268055|NCT01336608|O3|Outcome|FF/VI 100/25 µg QD|Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
268056|NCT01336608|O2|Outcome|VI 25 µg QD|Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
268057|NCT01336608|O1|Outcome|Placebo QD|Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
268058|NCT01336608|O3|Outcome|FF/VI 100/25 µg QD|Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
268059|NCT01336608|O2|Outcome|VI 25 µg QD|Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
268060|NCT01336608|O1|Outcome|Placebo QD|Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
268061|NCT01336608|O3|Outcome|FF/VI 100/25 µg QD|Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
268062|NCT01336608|O2|Outcome|VI 25 µg QD|Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
268063|NCT01336608|O1|Outcome|Placebo QD|Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
268064|NCT01336608|E3|Reported Event|FF/VI 100/25 µg QD|Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
268065|NCT01336608|E2|Reported Event|VI 25 µg QD|Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
268066|NCT01336608|E1|Reported Event|Placebo QD|Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
268067|NCT01336569|B1|Baseline|DuoTrav|Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
268068|NCT01336569|P1|Participant Flow|DuoTrav|Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
268069|NCT01336569|O1|Outcome|DuoTrav|Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
268070|NCT01336569|E1|Reported Event|DuoTrav|Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
268077|NCT01336413|O1|Outcome|Pregnenolone|Pregnenolone: Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
268078|NCT01336413|O2|Outcome|Placebo|Placebo: Same as active comparator, except placebo dispensed.
268079|NCT01336413|O1|Outcome|Pregnenolone|Pregnenolone: Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
268080|NCT01336413|O2|Outcome|Placebo|Placebo: Same as active comparator, except placebo dispensed.
268081|NCT01336413|O1|Outcome|Pregnenolone|Pregnenolone: Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
268082|NCT01336413|O2|Outcome|Placebo|Placebo: Same as active comparator, except placebo dispensed.
268083|NCT01336413|O1|Outcome|Pregnenolone|Pregnenolone: Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
268084|NCT01336413|O2|Outcome|Placebo|Placebo: Same as active comparator, except placebo dispensed.
268085|NCT01336413|O1|Outcome|Pregnenolone|Pregnenolone: Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
268086|NCT01336413|O2|Outcome|Placebo|Placebo: Same as active comparator, except placebo dispensed.
268087|NCT01336413|O1|Outcome|Pregnenolone|Pregnenolone: Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
268088|NCT01336413|E2|Reported Event|Placebo|Placebo: Same as active comparator, except placebo dispensed.
268089|NCT01336413|E1|Reported Event|Pregnenolone|Pregnenolone: Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
268090|NCT01336296|B3|Baseline|Total|Total of all reporting groups
268091|NCT01336296|B2|Baseline|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
268092|NCT01336296|B1|Baseline|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
268093|NCT01336296|P2|Participant Flow|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
268094|NCT01336296|P1|Participant Flow|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
268095|NCT01336296|O2|Outcome|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
268096|NCT01336296|O1|Outcome|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
268097|NCT01336296|O2|Outcome|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
268098|NCT01336296|O1|Outcome|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
268099|NCT01336296|O2|Outcome|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
268100|NCT01336296|O1|Outcome|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
268101|NCT01336296|O2|Outcome|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
268102|NCT01336296|O1|Outcome|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
268103|NCT01336296|O2|Outcome|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
268104|NCT01336296|O1|Outcome|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
268105|NCT01336296|E2|Reported Event|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
268193|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
290463|NCT01271036|O2|Outcome|Female|Female Participants
268106|NCT01336296|E1|Reported Event|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
268107|NCT01336205|B3|Baseline|Total|Total of all reporting groups
268108|NCT01336205|B2|Baseline|Usual Care|Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
268109|NCT01336205|B1|Baseline|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
268110|NCT01336205|P2|Participant Flow|Usual Care|Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
268111|NCT01336205|P1|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
268112|NCT01336205|O2|Outcome|Usual Care|Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
268113|NCT01336205|O1|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
268114|NCT01336205|O2|Outcome|Usual Care|Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
268115|NCT01336205|O1|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
268116|NCT01336205|O2|Outcome|Usual Care|Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
268117|NCT01336205|O1|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
268118|NCT01336205|E2|Reported Event|Usual Care|
268119|NCT01336205|E1|Reported Event|NKTR-118 25 mg|
268120|NCT01336140|B3|Baseline|Total|Total of all reporting groups
268121|NCT01336140|B2|Baseline|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
268122|NCT01336140|B1|Baseline|Aminophylline|75 mg of intravenous aminophylline.
268123|NCT01336140|P2|Participant Flow|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
268124|NCT01336140|P1|Participant Flow|Aminophylline|75 mg of intravenous aminophylline.
268125|NCT01336140|O2|Outcome|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
268126|NCT01336140|O1|Outcome|Aminophylline|75 mg of intravenous aminophylline.
268127|NCT01336140|O2|Outcome|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
268128|NCT01336140|O1|Outcome|Aminophylline|75 mg of intravenous aminophylline.
268129|NCT01336140|O2|Outcome|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
268130|NCT01336140|O1|Outcome|Aminophylline|75 mg of intravenous aminophylline.
268131|NCT01336140|O2|Outcome|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
268132|NCT01336140|O1|Outcome|Aminophylline|75 mg of intravenous aminophylline.
268133|NCT01336140|E2|Reported Event|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
268134|NCT01336140|E1|Reported Event|Aminophylline|75 mg of intravenous aminophylline.
268135|NCT01336023|B4|Baseline|Total|Total of all reporting groups
268136|NCT01336023|B3|Baseline|Liraglutide|Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
268137|NCT01336023|B2|Baseline|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
268138|NCT01336023|B1|Baseline|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
268139|NCT01336023|P3|Participant Flow|Liraglutide|Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
268140|NCT01336023|P2|Participant Flow|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
268141|NCT01336023|P1|Participant Flow|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
268142|NCT01336023|O2|Outcome|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
268194|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
268238|NCT01335789|O1|Outcome|Oxytocin|"intranasal administration~Oxytocin: 40 IUs"
268143|NCT01336023|O1|Outcome|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
268144|NCT01336023|O3|Outcome|Liraglutide|Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
268145|NCT01336023|O2|Outcome|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
268146|NCT01336023|O1|Outcome|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
268147|NCT01336023|O3|Outcome|Liraglutide|Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
268148|NCT01336023|O2|Outcome|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
268149|NCT01336023|O1|Outcome|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
268150|NCT01336023|O3|Outcome|Liraglutide|Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
268151|NCT01336023|O2|Outcome|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
268152|NCT01336023|O1|Outcome|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
268153|NCT01336023|O3|Outcome|Liraglutide|Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
268154|NCT01336023|O2|Outcome|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
268155|NCT01336023|O1|Outcome|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
268156|NCT01336023|E3|Reported Event|Liraglutide|Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
268157|NCT01336023|E2|Reported Event|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
268228|NCT01335867|O2|Outcome|Placebo|Placebo: Placebo pills
268158|NCT01336023|E1|Reported Event|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
268159|NCT01335997|B3|Baseline|Total|Total of all reporting groups
268160|NCT01335997|B2|Baseline|ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2)|Study drug was co-administered as extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) (ERN/LRPT + SIM) during Periods I and II for 12 weeks and extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period III for 8 weeks.
268161|NCT01335997|B1|Baseline|ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1)|Study drug was administered as extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period I and II for 12 weeks and extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) during Period III for 8 weeks.
268162|NCT01335997|P2|Participant Flow|ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2)|Study drug was co-administered as extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) (ERN/LRPT + SIM) during Periods I and II for 12 weeks and extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period III for 8 weeks.
268163|NCT01335997|P1|Participant Flow|ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1)|Study drug was administered as extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period I and II for 12 weeks and extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) during Period III for 8 weeks.
268164|NCT01335997|O2|Outcome|ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2)|Study drug was co-administered as extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) (ERN/LRPT + SIM) during Periods I and II for 12 weeks and extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period III for 8 weeks.
268165|NCT01335997|O1|Outcome|ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1)|Study drug was administered as extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period I and II for 12 weeks and extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) during Period III for 8 weeks.
268166|NCT01335997|O2|Outcome|ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2)|Study drug was co-administered as extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) (ERN/LRPT + SIM) during Periods I and II for 12 weeks and extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period III for 8 weeks.
268167|NCT01335997|O1|Outcome|ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1)|Study drug was administered as extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period I and II for 12 weeks and extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) during Period III for 8 weeks.
268168|NCT01335997|E4|Reported Event|Seq 2 (Period III): ERN/LRPT+SIM → ERN/LRPT/SIM|ERN/LRPT/SIMVA 2 g/20 mg for 8 weeks (Period III)
268169|NCT01335997|E3|Reported Event|Seq 1 (Period III): ERN/LRPT/SIMVA → ERN/LRPT+SIMVA|ERN/LRPT 2 g + SIMVA 20 mg for 8 weeks (Period III)
268170|NCT01335997|E2|Reported Event|Seq 2 (Periods I+II): ERN/LRPT+SIM → ERN/LRPT/SIM|ERN/LRPT 1 g + SIMVA 10 mg for 4 weeks (Period I) followed by ERN/LRPT 2 g + SIMVA 20 mg for 8 weeks (Period II)
268171|NCT01335997|E1|Reported Event|Seq 1 (Periods I+II): ERN/LRPT/SIMVA → ERN/LRPT+SIMVA|ERN/LRPT/SIMVA 1 g/10 mg for 4 weeks (Period I) followed by ERN/LRPT/SIMVA 2 g/20 mg for 8 weeks (Period II)
268172|NCT01335971|B4|Baseline|Total|Total of all reporting groups
268173|NCT01335971|B3|Baseline|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
268174|NCT01335971|B2|Baseline|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
268175|NCT01335971|B1|Baseline|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
268176|NCT01335971|P3|Participant Flow|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
268177|NCT01335971|P2|Participant Flow|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
268178|NCT01335971|P1|Participant Flow|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
268179|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
268180|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
268181|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
268182|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
268183|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
268184|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
268185|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
268186|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
268187|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
268188|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
268189|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
268190|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
268191|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
268192|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
268195|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
268196|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
268197|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
268198|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
268199|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
268200|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
268201|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
268202|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
268203|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
268204|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
268205|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
268206|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
268207|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
268208|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
268209|NCT01335971|E3|Reported Event|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
268210|NCT01335971|E2|Reported Event|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
268211|NCT01335971|E1|Reported Event|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
268212|NCT01335932|B3|Baseline|Total|Total of all reporting groups
268213|NCT01335932|B2|Baseline|Placebo|"normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge~Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.~The placebo is an IV solution that does not contain any active medications."
268214|NCT01335932|B1|Baseline|IV Ganciclovir|"5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge~IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose."
268215|NCT01335932|P2|Participant Flow|Placebo|"normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge~Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.~The placebo is an IV solution that does not contain any active medications."
268216|NCT01335932|P1|Participant Flow|IV Ganciclovir|"5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge~IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose."
268217|NCT01335932|O2|Outcome|Placebo|"normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge~Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.~The placebo is an IV solution that does not contain any active medications."
268218|NCT01335932|O1|Outcome|IV Ganciclovir|"5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge~IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose."
268219|NCT01335932|E2|Reported Event|Placebo|"normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge~Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.~The placebo is an IV solution that does not contain any active medications."
268220|NCT01335932|E1|Reported Event|IV Ganciclovir|"5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge~IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose."
268221|NCT01335867|B3|Baseline|Total|Total of all reporting groups
268222|NCT01335867|B2|Baseline|Placebo|Placebo: Placebo pills
268223|NCT01335867|B1|Baseline|Vigabatrin|Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks
268224|NCT01335867|P2|Participant Flow|Placebo|Placebo: Placebo pills
268225|NCT01335867|P1|Participant Flow|Vigabatrin|Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks
268226|NCT01335867|O2|Outcome|Placebo|Placebo: Placebo pills
268227|NCT01335867|O1|Outcome|Vigabatrin|Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks
268240|NCT01335789|O1|Outcome|Oxytocin|"intranasal administration~Oxytocin: 40 IUs"
268241|NCT01335789|O2|Outcome|Saline|"intranasal administration~Saline: 40 IUs"
268242|NCT01335789|O1|Outcome|Oxytocin|"intranasal administration~Oxytocin: 40 IUs"
268243|NCT01335789|E2|Reported Event|Saline|"intranasal administration~Saline: 40 IUs"
268244|NCT01335789|E1|Reported Event|Oxytocin|"intranasal administration~Oxytocin: 40 IUs"
268245|NCT01335750|B1|Baseline|Multipurpose Solution|To obtain results of a clinical comparison of several multipurpose contact lens solutions among adapted hydrogel lens users wearing Avaira contact lenses
268246|NCT01335750|P1|Participant Flow|Multipurpose Solution|To obtain results of a clinical comparison of several multipurpose contact lens solutions among adapted hydrogel lens users wearing Avaira contact lenses
268247|NCT01335750|O4|Outcome|Multipurpose Solution #4|Saline Solution
268248|NCT01335750|O3|Outcome|Multipurpose Solution #3|Ciba ClearCare Multipurpose Solution
268249|NCT01335750|O2|Outcome|Multipurpose Solution #2|B&L Renu Fresh Multipurpose Solution
268250|NCT01335750|O1|Outcome|Multipurpose Solution #1|Optifree Replenish
268251|NCT01335750|O4|Outcome|Multipurpose Solution #4|Saline solution
268252|NCT01335750|O3|Outcome|Multipurpose Solution #3|Ciba ClearCare Multipurpose Solution
268253|NCT01335750|O2|Outcome|Multipurpose Solution #2|B&L Renu Fresh Multipurpose Solution
268254|NCT01335750|O1|Outcome|Mutlipurpose Solution #1|Optifree Replenish Multipurpose Solution
268255|NCT01335750|O4|Outcome|Multipurpose Solution #4|Saline Solution
268256|NCT01335750|O3|Outcome|Multipurpose Solution #3|Ciba ClearCare Multipurpose Solution
268257|NCT01335750|O2|Outcome|Multipurpose Solution #2|Optifree Replenish Multipurpose Solution
268258|NCT01335750|O1|Outcome|Multipurpose Solution #1|B&L Renu Fresh Multipurpose Solution
268259|NCT01335750|O4|Outcome|Multipurpose Solution #4|Saline Multipurpose Solution
268260|NCT01335750|O3|Outcome|Multipurpose Solution #3|Ciba ClearCare Multipurpose Solution
268261|NCT01335750|O2|Outcome|Multipurpose Solution #2|Optifree Replenish Multipurpose Solution
268262|NCT01335750|O1|Outcome|Multipurpose Solution #1|B&L Renu Fresh Multipurpose Solution
268263|NCT01335750|E1|Reported Event|Multipurpose Solution|To obtain results of a clinical comparison of several multipurpose contact lens solutions among adapted hydrogel lens users wearing Avaira contact lenses
268264|NCT01335724|B3|Baseline|Total|Total of all reporting groups
268265|NCT01335724|B2|Baseline|Placebo Gel|
268266|NCT01335724|B1|Baseline|Diclofenac Diethylamine 1.16% Gel|
268267|NCT01335724|P2|Participant Flow|Placebo Gel|
268268|NCT01335724|P1|Participant Flow|Diclofenac Diethylamine 1.16% Gel|
268269|NCT01335724|O2|Outcome|Placebo Gel|
268270|NCT01335724|O1|Outcome|Diclofenac Diethylamine 1.16% Gel|
268271|NCT01335724|O2|Outcome|Placebo Gel|
268272|NCT01335724|O1|Outcome|Diclofenac Diethylamine 1.16% Gel|
268273|NCT01335724|O2|Outcome|Placebo Gel|
268274|NCT01335724|O1|Outcome|Diclofenac Diethylamine 1.16% Gel|
268275|NCT01335724|E2|Reported Event|Placebo Gel|
268276|NCT01335724|E1|Reported Event|Diclofenac Diethylamine 1.16% Gel|
268277|NCT01335698|B6|Baseline|Total|Total of all reporting groups
268278|NCT01335698|B5|Baseline|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268279|NCT01335698|B4|Baseline|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268280|NCT01335698|B3|Baseline|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268281|NCT01335698|B2|Baseline|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 200 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268282|NCT01335698|B1|Baseline|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks.Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268283|NCT01335698|P5|Participant Flow|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268284|NCT01335698|P4|Participant Flow|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268285|NCT01335698|P3|Participant Flow|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268286|NCT01335698|P2|Participant Flow|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268287|NCT01335698|P1|Participant Flow|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268288|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268289|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268290|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268291|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 200 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268292|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268293|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268294|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268295|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268296|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268627|NCT01335191|P2|Participant Flow|Placebo|Two subcutaneous injections of placebo at Day 0 and Week 3.
268297|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268298|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268299|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268300|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268301|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268302|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268303|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268304|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268305|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268306|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 200 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268307|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268308|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets,100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268309|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268477|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268310|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268311|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268312|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268313|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268314|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268315|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268316|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 200 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268317|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268318|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268319|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268320|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268321|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268322|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268622|NCT01335230|E2|Reported Event|10 HCV Mono-infected Subjects|10 subjects infected with HCV only
268323|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268324|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268325|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268326|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268327|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268328|NCT01335698|E5|Reported Event|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268329|NCT01335698|E4|Reported Event|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks.Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268330|NCT01335698|E3|Reported Event|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268331|NCT01335698|E2|Reported Event|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 200 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268332|NCT01335698|E1|Reported Event|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
268333|NCT01335685|B5|Baseline|Total|Total of all reporting groups
268334|NCT01335685|B4|Baseline|Arm D: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles).
268335|NCT01335685|B3|Baseline|Arm C: Ixazomib 3.0 - 4.0 mg|Ixazomib 3.0 - 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles).
268336|NCT01335685|B2|Baseline|Arm B: Ixazomib 3.0 - 5.5 mg|Ixazomib 3.0 - 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1-4 for in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles).
268337|NCT01335685|B1|Baseline|Arm A: Ixazomib 3.0 - 3.7 mg|Ixazomib 3.0 - 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles).
268338|NCT01335685|P8|Participant Flow|Arm D: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles [38 months]).
268339|NCT01335685|P7|Participant Flow|Arm C: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 21 cycles [24 months]).
268340|NCT01335685|P6|Participant Flow|Arm C: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles [40 months]).
268341|NCT01335685|P5|Participant Flow|Arm B: Ixazomib 5.5 mg|Ixazomib 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 24 cycles [24 months]).
268342|NCT01335685|P4|Participant Flow|Arm B: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 cycle plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles [58 months]).
268343|NCT01335685|P3|Participant Flow|Arm B: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 15 maintenance cycles; overall up to 27 cycles [25 months]).
268344|NCT01335685|P2|Participant Flow|Arm A: Ixazomib 3.7 mg|Ixazomib 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 10 maintenance cycles; overall up to 19 cycles [21 months]).
268345|NCT01335685|P1|Participant Flow|Arm A: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle for up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles [34 months]).
268346|NCT01335685|O1|Outcome|Arm B: Ixazomib 4.0 mg (RP2D)|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles [58 months]).
268347|NCT01335685|O8|Outcome|Arm D: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles [38 months]).
268348|NCT01335685|O7|Outcome|Arm C: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 21 cycles [24 months]).
268349|NCT01335685|O6|Outcome|Arm C: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles [40 months]).
268462|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
290464|NCT01271036|O1|Outcome|Male|Male Participants
268350|NCT01335685|O5|Outcome|Arm B: Ixazomib 5.5 mg|Ixazomib 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 24 cycles [24 months]).
268351|NCT01335685|O4|Outcome|Arm B: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 cycle plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles [58 months]).
268352|NCT01335685|O3|Outcome|Arm B: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 15 maintenance cycles; overall up to 27 cycles [25 months]).
268353|NCT01335685|O2|Outcome|Arm A: Ixazomib 3.7 mg|Ixazomib 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 10 maintenance cycles; overall up to 19 cycles [21 months]).
268354|NCT01335685|O1|Outcome|Arm A: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle for up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles [34 months]).
268355|NCT01335685|O1|Outcome|Arm B: Ixazomib 4.0 mg (RP2D)|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles [58 months]).
268356|NCT01335685|O1|Outcome|Arm B: Ixazomib 4.0 mg (RP2D)|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles [58 months]).
268357|NCT01335685|O1|Outcome|Arm B: Ixazomib 4.0 mg (RP2D)|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles [58 months]).
268358|NCT01335685|O1|Outcome|Arm B: Ixazomib 4.0 mg (RP2D)|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles [58 months]).
268359|NCT01335685|O1|Outcome|Arm B: Ixazomib 4.0 mg (RP2D)|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles [58 months]).
268360|NCT01335685|O1|Outcome|Arm B: Ixazomib 4.0 mg (RP2D)|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles [58 months]).
268361|NCT01335685|O8|Outcome|Arm D: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles [38 months]).
268362|NCT01335685|O7|Outcome|Arm C: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 21 cycles [24 months]).
268463|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268464|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268363|NCT01335685|O6|Outcome|Arm C: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles [40 months]).
268364|NCT01335685|O5|Outcome|Arm B: Ixazomib 5.5 mg|Ixazomib 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 24 cycles [24 months]).
268365|NCT01335685|O4|Outcome|Arm B: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 cycle plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles [58 months]).
268366|NCT01335685|O3|Outcome|Arm B: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 15 maintenance cycles; overall up to 27 cycles [25 months]).
268367|NCT01335685|O2|Outcome|Arm A: Ixazomib 3.7 mg|Ixazomib 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 10 maintenance cycles; overall up to 19 cycles [21 months]).
268368|NCT01335685|O1|Outcome|Arm A: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle for up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles [34 months]).
268369|NCT01335685|O8|Outcome|Arm D: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles [38 months]).
268370|NCT01335685|O7|Outcome|Arm C: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 21 cycles [24 months]).
268371|NCT01335685|O6|Outcome|Arm C: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles [40 months]).
268372|NCT01335685|O5|Outcome|Arm B: Ixazomib 5.5 mg|Ixazomib 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 24 cycles [24 months]).
268373|NCT01335685|O4|Outcome|Arm B: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 cycle plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles [58 months]).
268374|NCT01335685|O3|Outcome|Arm B: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 15 maintenance cycles; overall up to 27 cycles [25 months]).
268375|NCT01335685|O2|Outcome|Arm A: Ixazomib 3.7 mg|Ixazomib 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 10 maintenance cycles; overall up to 19 cycles [21 months]).
268465|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268466|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268376|NCT01335685|O1|Outcome|Arm A: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle for up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles [34 months]).
268377|NCT01335685|O8|Outcome|Arm D: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles [38 months]).
268378|NCT01335685|O7|Outcome|Arm C: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 21 cycles [24 months]).
268379|NCT01335685|O6|Outcome|Arm C: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles [40 months]).
268380|NCT01335685|O5|Outcome|Arm B: Ixazomib 5.5 mg|Ixazomib 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 24 cycles [24 months]).
268381|NCT01335685|O4|Outcome|Arm B: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 cycle plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles [58 months]).
268382|NCT01335685|O3|Outcome|Arm B: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 15 maintenance cycles; overall up to 27 cycles [25 months]).
268383|NCT01335685|O2|Outcome|Arm A: Ixazomib 3.7 mg|Ixazomib 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 10 maintenance cycles; overall up to 19 cycles [21 months]).
268384|NCT01335685|O1|Outcome|Arm A: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle for up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles [34 months]).
268385|NCT01335685|O8|Outcome|Arm D: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles [38 months]).
268386|NCT01335685|O7|Outcome|Arm C: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 21 cycles [24 months]).
268387|NCT01335685|O6|Outcome|Arm C: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles [40 months]).
268388|NCT01335685|O5|Outcome|Arm B: Ixazomib 5.5 mg|Ixazomib 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 24 cycles [24 months]).
268467|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268468|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268389|NCT01335685|O4|Outcome|Arm B: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 cycle plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles [58 months]).
268390|NCT01335685|O3|Outcome|Arm B: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 15 maintenance cycles; overall up to 27 cycles [25 months]).
268391|NCT01335685|O2|Outcome|Arm A: Ixazomib 3.7 mg|Ixazomib 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 10 maintenance cycles; overall up to 19 cycles [21 months]).
268392|NCT01335685|O1|Outcome|Arm A: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle for up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles [34 months]).
268393|NCT01335685|O8|Outcome|Arm D: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles [38 months]).
268394|NCT01335685|O7|Outcome|Arm C: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 21 cycles [24 months]).
268395|NCT01335685|O6|Outcome|Arm C: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles [40 months]).
268396|NCT01335685|O5|Outcome|Arm B: Ixazomib 5.5 mg|Ixazomib 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 24 cycles [24 months]).
268397|NCT01335685|O4|Outcome|Arm B: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 cycle plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles [58 months]).
268398|NCT01335685|O3|Outcome|Arm B: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 15 maintenance cycles; overall up to 27 cycles [25 months]).
268399|NCT01335685|O2|Outcome|Arm A: Ixazomib 3.7 mg|Ixazomib 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 10 maintenance cycles; overall up to 19 cycles [21 months]).
268400|NCT01335685|O1|Outcome|Arm A: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle for up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles [34 months]).
268401|NCT01335685|O8|Outcome|Arm D: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles [38 months]).
268469|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268470|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268402|NCT01335685|O7|Outcome|Arm C: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 21 cycles [24 months]).
268403|NCT01335685|O6|Outcome|Arm C: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles [40 months]).
268404|NCT01335685|O5|Outcome|Arm B: Ixazomib 5.5 mg|Ixazomib 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 24 cycles [24 months]).
268405|NCT01335685|O4|Outcome|Arm B: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 cycle plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles [58 months]).
268406|NCT01335685|O3|Outcome|Arm B: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 15 maintenance cycles; overall up to 27 cycles [25 months]).
268407|NCT01335685|O2|Outcome|Arm A: Ixazomib 3.7 mg|Ixazomib 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 10 maintenance cycles; overall up to 19 cycles [21 months]).
268408|NCT01335685|O1|Outcome|Arm A: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle for up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles [34 months]).
268409|NCT01335685|O8|Outcome|Arm D: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles [38 months]).
268410|NCT01335685|O7|Outcome|Arm C: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 21 cycles [24 months]).
268411|NCT01335685|O6|Outcome|Arm C: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles [40 months]).
268412|NCT01335685|O5|Outcome|Arm B: Ixazomib 5.5 mg|Ixazomib 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 24 cycles [24 months]).
268413|NCT01335685|O4|Outcome|Arm B: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 cycle plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles [58 months]).
268414|NCT01335685|O3|Outcome|Arm B: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 15 maintenance cycles; overall up to 27 cycles [25 months]).
268471|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268472|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268415|NCT01335685|O2|Outcome|Arm A: Ixazomib 3.7 mg|Ixazomib 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 10 maintenance cycles; overall up to 19 cycles [21 months]).
268416|NCT01335685|O1|Outcome|Arm A: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle for up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles [34 months]).
268417|NCT01335685|O8|Outcome|Arm D: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles [38 months]).
268418|NCT01335685|O7|Outcome|Arm C: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 21 cycles [24 months]).
268419|NCT01335685|O6|Outcome|Arm C: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles [40 months]).
268420|NCT01335685|O5|Outcome|Arm B: Ixazomib 5.5 mg|Ixazomib 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 24 cycles [24 months]).
268421|NCT01335685|O4|Outcome|Arm B: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 cycle plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles [58 months]).
268422|NCT01335685|O3|Outcome|Arm B: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 15 maintenance cycles; overall up to 27 cycles [25 months]).
268423|NCT01335685|O2|Outcome|Arm A: Ixazomib 3.7 mg|Ixazomib 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 10 maintenance cycles; overall up to 19 cycles [21 months]).
268424|NCT01335685|O1|Outcome|Arm A: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle for up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles [34 months]).
268425|NCT01335685|O8|Outcome|Arm D: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles [38 months]).
268426|NCT01335685|O7|Outcome|Arm C: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 21 cycles [24 months]).
268427|NCT01335685|O6|Outcome|Arm C: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles [40 months]).
268473|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268474|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268428|NCT01335685|O5|Outcome|Arm B: Ixazomib 5.5 mg|Ixazomib 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 24 cycles [24 months]).
268429|NCT01335685|O4|Outcome|Arm B: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 cycle plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles [58 months]).
268430|NCT01335685|O3|Outcome|Arm B: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 15 maintenance cycles; overall up to 27 cycles [25 months]).
268431|NCT01335685|O2|Outcome|Arm A: Ixazomib 3.7 mg|Ixazomib 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 10 maintenance cycles; overall up to 19 cycles [21 months]).
268432|NCT01335685|O1|Outcome|Arm A: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle for up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles [34 months]).
268433|NCT01335685|O1|Outcome|Arm B: Ixazomib 4.0 mg (RP2D)|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles [58 months]).
268434|NCT01335685|O4|Outcome|Arm D: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles).
268435|NCT01335685|O3|Outcome|Arm C: Ixazomib 3.0 - 4.0 mg|Ixazomib 3.0 - 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles).
268436|NCT01335685|O2|Outcome|Arm B: Ixazomib 3.0 - 5.5 mg|Ixazomib 3.0 - 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1-4 for in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles).
268437|NCT01335685|O1|Outcome|Arm A: Ixazomib 3.0 - 3.7 mg|Ixazomib 3.0 - 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles).
268438|NCT01335685|E8|Reported Event|Arm D: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles [38 months]).
268439|NCT01335685|E7|Reported Event|Arm C: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 21 cycles [24 months]).
268440|NCT01335685|E6|Reported Event|Arm C: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles [40 months]).
268475|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268476|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268441|NCT01335685|E5|Reported Event|Arm B: Ixazomib 5.5 mg|Ixazomib 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 24 cycles [24 months]).
268442|NCT01335685|E4|Reported Event|Arm B: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 cycle plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles [58 months]).
268443|NCT01335685|E3|Reported Event|Arm B: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 15 maintenance cycles; overall up to 27 cycles [25 months]).
268444|NCT01335685|E2|Reported Event|Arm A: Ixazomib 3.7 mg|Ixazomib 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 10 maintenance cycles; overall up to 19 cycles [21 months]).
268445|NCT01335685|E1|Reported Event|Arm A: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle for up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles [34 months]).
268446|NCT01335542|B3|Baseline|Total|Total of all reporting groups
268447|NCT01335542|B2|Baseline|Local Infiltration|meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
268448|NCT01335542|B1|Baseline|Epidural Pathway|meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV
268449|NCT01335542|P2|Participant Flow|Local Infiltration|meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
268450|NCT01335542|P1|Participant Flow|Epidural Pathway|meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV
268451|NCT01335542|O2|Outcome|Local Infiltration|meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
268452|NCT01335542|O1|Outcome|Epidural Pathway|meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV
268453|NCT01335542|E2|Reported Event|Local Infiltration|meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
268454|NCT01335542|E1|Reported Event|Epidural Pathway|meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV
268455|NCT01335477|B3|Baseline|Total|Total of all reporting groups
268456|NCT01335477|B2|Baseline|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268457|NCT01335477|B1|Baseline|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268458|NCT01335477|P2|Participant Flow|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268459|NCT01335477|P1|Participant Flow|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268460|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268461|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268478|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268479|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268480|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268481|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268482|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268483|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268484|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268485|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268486|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268487|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268488|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268489|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268490|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268491|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268492|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268493|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268494|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268495|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268496|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268497|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268498|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268499|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268500|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268501|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268502|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268503|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268504|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268505|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268506|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268507|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268508|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268509|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268510|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268511|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268512|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268513|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268514|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268515|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268516|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268517|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
268623|NCT01335230|E1|Reported Event|10 HIV Mono-infected Subjects|10 subjects infected with HIV only
268518|NCT01335477|E2|Reported Event|Nintedanib 150mg Bid|Oral administration of soft gelatine capsules of Nintedanib 150 mg twice daily (bid). Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events.
268519|NCT01335477|E1|Reported Event|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules.
268520|NCT01335464|B3|Baseline|Total|Total of all reporting groups
268521|NCT01335464|B2|Baseline|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268522|NCT01335464|B1|Baseline|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268523|NCT01335464|P2|Participant Flow|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268524|NCT01335464|P1|Participant Flow|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268525|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268526|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268527|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268528|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268529|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268530|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268531|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268532|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268533|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268534|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268535|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268536|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268537|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268538|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268539|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268540|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268541|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268542|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268543|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268544|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268545|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268546|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268547|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268548|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268549|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268550|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268551|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268552|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268553|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268554|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268555|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268556|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268557|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268558|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268559|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268560|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268561|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268562|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268563|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268564|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268565|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268566|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268567|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268568|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268569|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268570|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268571|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268572|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268573|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268574|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268575|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268576|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268577|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268578|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268579|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268580|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268581|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
268582|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
268583|NCT01335464|E2|Reported Event|Nintedanib 150mg Bid|Oral administration of soft gelatine capsules of Nintedanib 150 mg twice daily (bid). Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events.
268584|NCT01335464|E1|Reported Event|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules.
268585|NCT01335308|B4|Baseline|Total|Total of all reporting groups
268586|NCT01335308|B3|Baseline|Higher Dose Motivational Interviewing|Higher Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner and 6 x visits (in phone or in person) with a Registered Dietitian, also trained in Motivational Interviewing. Outcomes will be collected at 1 year and 2 years after enrollment
268587|NCT01335308|B2|Baseline|Moderate Dose Motivational Interviewing|Moderate Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner. Outcomes will be collected at 1 year and 2 years after enrollment
268588|NCT01335308|B1|Baseline|Standard Care With Education Materials|Standard Care: Practitioners will receive 2 hour obesity lecture and ½ day protocol training. Families recruited are given parent education materials. Outcomes will be collected at 1 year and 2 years after enrollment
268589|NCT01335308|P3|Participant Flow|Higher Dose Motivational Interviewing|Higher Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner and 6 x visits (in phone or in person) with a Registered Dietitian, also trained in Motivational Interviewing. Outcomes will be collected at 1 year and 2 years after enrollment
268590|NCT01335308|P2|Participant Flow|Moderate Dose Motivational Interviewing|Moderate Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner. Outcomes will be collected at 1 year and 2 years after enrollment
268591|NCT01335308|P1|Participant Flow|Standard Care With Education Materials|Standard Care: Practitioners will receive 2 hour obesity lecture and ½ day protocol training. Families recruited are given parent education materials. Outcomes will be collected at 1 year and 2 years after enrollment
268624|NCT01335191|B3|Baseline|Total|Total of all reporting groups
268625|NCT01335191|B2|Baseline|Placebo|Two subcutaneous injections of placebo at Day 0 and Week 3.
268626|NCT01335191|B1|Baseline|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
268592|NCT01335308|O3|Outcome|Higher Dose Motivational Interviewing|Higher Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner and 6 x visits (in phone or in person) with a Registered Dietitian, also trained in Motivational Interviewing. Outcomes will be collected at 1 year and 2 years after enrollment
268593|NCT01335308|O2|Outcome|Moderate Dose Motivational Interviewing|Moderate Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner. Outcomes will be collected at 1 year and 2 years after enrollment
268594|NCT01335308|O1|Outcome|Standard Care With Education Materials|Standard Care: Practitioners will receive 2 hour obesity lecture and ½ day protocol training. Families recruited are given parent education materials. Outcomes will be collected at 1 year and 2 years after enrollment
268595|NCT01335308|O3|Outcome|Higher Dose Motivational Interviewing|Higher Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner and 6 x visits (in phone or in person) with a Registered Dietitian, also trained in Motivational Interviewing. Outcomes will be collected at 1 year and 2 years after enrollment
268596|NCT01335308|O2|Outcome|Moderate Dose Motivational Interviewing|Moderate Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner. Outcomes will be collected at 1 year and 2 years after enrollment
268597|NCT01335308|O1|Outcome|Standard Care With Education Materials|Standard Care: Practitioners will receive 2 hour obesity lecture and ½ day protocol training. Families recruited are given parent education materials. Outcomes will be collected at 1 year and 2 years after enrollment
268598|NCT01335308|O3|Outcome|Higher Dose Motivational Interviewing|Higher Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner and 6 x visits (in phone or in person) with a Registered Dietitian, also trained in Motivational Interviewing. Outcomes will be collected at 1 year and 2 years after enrollment
268599|NCT01335308|O2|Outcome|Moderate Dose Motivational Interviewing|Moderate Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner. Outcomes will be collected at 1 year and 2 years after enrollment
268600|NCT01335308|O1|Outcome|Standard Care With Education Materials|Standard Care: Practitioners will receive 2 hour obesity lecture and ½ day protocol training. Families recruited are given parent education materials. Outcomes will be collected at 1 year and 2 years after enrollment
268601|NCT01335308|O3|Outcome|Higher Dose Motivational Interviewing|Higher Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner and 6 x visits (in phone or in person) with a Registered Dietitian, also trained in Motivational Interviewing. Outcomes will be collected at 1 year and 2 years after enrollment
268602|NCT01335308|O2|Outcome|Moderate Dose Motivational Interviewing|Moderate Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner. Outcomes will be collected at 1 year and 2 years after enrollment
268603|NCT01335308|O1|Outcome|Standard Care With Education Materials|Standard Care: Practitioners will receive 2 hour obesity lecture and ½ day protocol training. Families recruited are given parent education materials. Outcomes will be collected at 1 year and 2 years after enrollment
268604|NCT01335308|E3|Reported Event|Higher Dose Motivational Interviewing|Higher Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner and 6 x visits (in phone or in person) with a Registered Dietitian, also trained in Motivational Interviewing. Outcomes will be collected at 1 year and 2 years after enrollment
268605|NCT01335308|E2|Reported Event|Moderate Dose Motivational Interviewing|Moderate Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner. Outcomes will be collected at 1 year and 2 years after enrollment
268606|NCT01335308|E1|Reported Event|Standard Care With Education Materials|Standard Care: Practitioners will receive 2 hour obesity lecture and ½ day protocol training. Families recruited are given parent education materials. Outcomes will be collected at 1 year and 2 years after enrollment
268607|NCT01335230|B5|Baseline|Total|Total of all reporting groups
268608|NCT01335230|B4|Baseline|10 Control Subjects|10 subjects without HIV, HCV, or both
268609|NCT01335230|B3|Baseline|10 HIV/HCV Co-infected Subjects|10 subjects infected with both HIV and HCV
268610|NCT01335230|B2|Baseline|10 HCV Mono-infected Subjects|10 subjects infected with HCV only
268611|NCT01335230|B1|Baseline|10 HIV Mono-infected Subjects|10 subjects infected with HIV only
268612|NCT01335230|P4|Participant Flow|10 Control Subjects|10 subjects without HIV, HCV, or both
268613|NCT01335230|P3|Participant Flow|10 HIV/HCV Co-infected Subjects|10 subjects infected with both HIV and HCV
268614|NCT01335230|P2|Participant Flow|10 HCV Mono-infected Subjects|10 subjects infected with HCV only
268615|NCT01335230|P1|Participant Flow|10 HIV Mono-infected Subjects|10 subjects infected with HIV only
268616|NCT01335230|O4|Outcome|10 Control Subjects|10 subjects without HIV, HCV, or both
268617|NCT01335230|O3|Outcome|10 HIV/HCV Co-infected Subjects|10 subjects infected with both HIV and HCV
268618|NCT01335230|O2|Outcome|10 HCV Mono-infected Subjects|10 subjects infected with HCV only
268619|NCT01335230|O1|Outcome|10 HIV Mono-infected Subjects|10 subjects infected with HIV only
268620|NCT01335230|E4|Reported Event|10 Control Subjects|10 subjects without HIV, HCV, or both
268621|NCT01335230|E3|Reported Event|10 HIV/HCV Co-infected Subjects|10 subjects infected with both HIV and HCV
268628|NCT01335191|P1|Participant Flow|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
268629|NCT01335191|O2|Outcome|Placebo|Two subcutaneous injections of placebo at Day 0 and Week 3.
268630|NCT01335191|O1|Outcome|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
268631|NCT01335191|E2|Reported Event|Placebo|Two subcutaneous injections of placebo at Day 0 and Week 3.
268632|NCT01335191|E1|Reported Event|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
268633|NCT01335061|B1|Baseline|All Participants|The data for all the participants is presented.
268634|NCT01335061|P1|Participant Flow|All Participants|The data for all the participants is presented.
268635|NCT01335061|O1|Outcome|All Participants|The data for all the participants is presented.
268636|NCT01335061|O2|Outcome|Prophylaxis Therapy|The prophylaxis regimen of approximately 100IU/kg once weekly was initiated at Visit 4.
268637|NCT01335061|O1|Outcome|On-Demand Therapy|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
268638|NCT01335061|O2|Outcome|Prophylaxis Therapy|The prophylaxis regimen of approximately 100IU/kg once weekly was initiated at Visit 4.
268639|NCT01335061|O1|Outcome|On-Demand Therapy|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
268640|NCT01335061|O1|Outcome|All Participants|The data for all the participants is presented.
268641|NCT01335061|O1|Outcome|All Population|The data for all the participants is presented.
268642|NCT01335061|O2|Outcome|On-Demand Therapy-Follow-up Infusions|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
268643|NCT01335061|O1|Outcome|On-Demand Therapy-First Infusion|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
268644|NCT01335061|O2|Outcome|Prophylaxis Therapy|The prophylaxis regimen of approximately 100 IU/kg once weekly was initiated at Visit 4.
268645|NCT01335061|O1|Outcome|On-Demand Therapy|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
268646|NCT01335061|E2|Reported Event|Prophylaxis Therapy|The prophylaxis regimen of approximately 100IU/kg once weekly was initiated at Visit 4.
268647|NCT01335061|E1|Reported Event|On-Demand Therapy|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
268648|NCT01334957|B1|Baseline|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
268649|NCT01334957|P1|Participant Flow|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period. A minimum of one dose of intravenous ibuprofen will be administered. At the discretion of the investigator, up to three additional doses of 800 mg intravenous ibuprofen may be administered at six hour intervals.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
268650|NCT01334957|O1|Outcome|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
268651|NCT01334957|O1|Outcome|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
268652|NCT01334957|O1|Outcome|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
268653|NCT01334957|O1|Outcome|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
268654|NCT01334957|O1|Outcome|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
268655|NCT01334957|E1|Reported Event|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
268656|NCT01334944|B1|Baseline|Intravenous Ibuprofen|"Intravenous ibuprofen (400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.~Intravenous ibuprofen: 400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
268657|NCT01334944|P2|Participant Flow|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
268658|NCT01334944|P1|Participant Flow|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
268659|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
268660|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
268689|NCT01334918|O1|Outcome|CTP: 0 Fixed Defects|Participants with zero fixed defects as assessed by regadenoson stress computed tomography perfusion (CTP).
290465|NCT01271036|O2|Outcome|Female|Female Participants
268661|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
268662|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
268663|NCT01334944|O1|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
268664|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
268665|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
268666|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
268667|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
268668|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
268669|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
268670|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
268671|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
268672|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
268673|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
268674|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
268675|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
268676|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
268677|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
268678|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
268679|NCT01334944|E2|Reported Event|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
268680|NCT01334944|E1|Reported Event|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
268681|NCT01334918|B3|Baseline|Total|Total of all reporting groups
268682|NCT01334918|B2|Baseline|Sequence 2: MDCT - SPECT|"Day 1: a regadenoson stress CTP and a rest CCTA/CTP procedure.~Day 2: a rest SPECT and a regadenoson stress SPECT procedure. Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection."
268683|NCT01334918|B1|Baseline|Sequence 1: SPECT - MDCT|"Day 1: a rest Single Photon Emission Computed Tomography (SPECT) and a regadenoson stress SPECT procedure.~Day 2: a regadenoson stress Computed Tomography Perfusion (CTP) and a rest Coronary Computed Tomography Angiography (CCTA)/CTP procedure.~Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection."
268684|NCT01334918|P2|Participant Flow|Sequence 2: MDCT - SPECT|"Day 1: a regadenoson stress CTP and a rest CCTA/CTP procedure.~Day 2: a rest SPECT and a regadenoson stress SPECT procedure. Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection."
268685|NCT01334918|P1|Participant Flow|Sequence 1: SPECT - MDCT|"Day 1: a rest Single Photon Emission Computed Tomography (SPECT) and a regadenoson stress SPECT procedure.~Day 2: a regadenoson stress Computed Tomography Perfusion (CTP) and a rest Coronary Computed Tomography Angiography (CCTA)/CTP procedure.~Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection."
268686|NCT01334918|O1|Outcome|SPECT + MDCT|Participants underwent both a rest and stress SPECT series and a rest and stress MDCT series.
268687|NCT01334918|O3|Outcome|CTP: All Fixed Defects|All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
268688|NCT01334918|O2|Outcome|CTP: ≥ 1 Fixed Defects|Participants with ≥ 1 fixed defects as assessed by regadenoson stress computed tomography perfusion (CTP).
268690|NCT01334918|O3|Outcome|CTP: All Reversible Defects|All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
268691|NCT01334918|O2|Outcome|CTP: ≥ 2 Reversible Defects|Participants with ≥ 2 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
268692|NCT01334918|O1|Outcome|CTP: 0 - 1 Reversible Defects|Participants with 0 - 1 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
268693|NCT01334918|O3|Outcome|CTP: All Reversible Defects|All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
268694|NCT01334918|O2|Outcome|CTP: ≥ 2 Reversible Defects|Participants with ≥ 2 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
268695|NCT01334918|O1|Outcome|CTP: 0 - 1 Reversible Defects|Participants with 0 - 1 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
268696|NCT01334918|O3|Outcome|CTP: All Reversible Defects|All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
268697|NCT01334918|O2|Outcome|CTP: ≥ 2 Reversible Defects|Participants with ≥ 2 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
268698|NCT01334918|O1|Outcome|CTP: 0 - 1 Reversible Defects|Participants with 0 - 1 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
268699|NCT01334918|O6|Outcome|MDCT: Reviewer 3|Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 3.
268700|NCT01334918|O5|Outcome|MDCT: Reviewer 2|Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 2.
268701|NCT01334918|O4|Outcome|MDCT: Reviewer 1|Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 1.
268702|NCT01334918|O3|Outcome|SPECT: Reviewer 3|Analysis of image quality of single photon emission computed tomography (SPECT) images performed by SPECT Reviewer 3.
268703|NCT01334918|O2|Outcome|SPECT: Reviewer 2|Analysis of image quality of single photon emission computed tomography (SPECT) images performed by SPECT Reviewer 2.
268704|NCT01334918|O1|Outcome|SPECT: Reviewer 1|Analysis of image quality of single photon emission computed tomography (SPECT) images performed by SPECT Reviewer 1.
268705|NCT01334918|O3|Outcome|CTP: All Reversible Defects|All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
268706|NCT01334918|O2|Outcome|CTP: ≥ 2 Reversible Defects|Participants with ≥ 2 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
268707|NCT01334918|O1|Outcome|CTP: 0 - 1 Reversible Defects|Participants with 0 - 1 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
268708|NCT01334918|E2|Reported Event|MDCT|Multidetector Computed Tomography (MDCT), composed of CCTA and regadenoson CTP. Regadenoson stress CTP was performed prior to rest CCTA/CTP imaging. Regadenoson 0.4 mg was administered prior to stress CTP as a single bolus injection. The rest CCTA/CTP was performed at least 30 minutes after completion of the stress CTP, after resolution of any symptoms brought on by the regadenoson infusion and after the participant's heart rate had returned to baseline.
268709|NCT01334918|E1|Reported Event|SPECT|Resting SPECT imaging was performed prior to regadenoson stress SPECT imaging. Imaging was conducted with one of two radiotracers (99mTc sestamibi or tetrofosmin). Regadenoson 0.4 mg was administered prior to stress SPECT as a single bolus injection.
268710|NCT01334866|B1|Baseline|Study Completion Cohort|91 subjects were enrolled, with 89 subjects receving the study treatment. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.
268711|NCT01334866|P1|Participant Flow|Minimally Invasive Coronary Artery Bypass Grafting|91 subjects were enrolled, with 89 subjects receving the study treatment. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.
268712|NCT01334866|O1|Outcome|Minimally Invasive Coronary Artery Bypass Grafting|89 Subjects received study treatment
268713|NCT01334866|O1|Outcome|Minimally Invasive Coronary Artery Bypass Grafting|89 Subjects received study treatment
268714|NCT01334866|O1|Outcome|Minimally Invasive Coronary Artery Bypass Grafting|91 subjects were enrolled, with 89 subjects receving the study treatment. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.
268715|NCT01334866|O1|Outcome|Study Procedure Cohort|89 Subjects received study treatment
268716|NCT01334866|O1|Outcome|Minimally Invasive Coronary Artery Bypass Grafting|89 Subjects received study treatment
268717|NCT01334866|E1|Reported Event|Study Procedure Cohort|89 Subjects received study treatment
268718|NCT01334723|B3|Baseline|Total|Total of all reporting groups
268719|NCT01334723|B2|Baseline|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
268720|NCT01334723|B1|Baseline|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
268721|NCT01334723|P2|Participant Flow|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
268722|NCT01334723|P1|Participant Flow|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
268723|NCT01334723|O2|Outcome|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
268724|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
268725|NCT01334723|O2|Outcome|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
268726|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
268727|NCT01334723|O2|Outcome|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
268728|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
268729|NCT01334723|O2|Outcome|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
268730|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
268731|NCT01334723|O2|Outcome|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
268732|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
268733|NCT01334723|O4|Outcome|Prostate Surgery Outcomes Cohort, MPR >80%|Participants in the prostate surgery outcomes cohort with an MPR >80%
268734|NCT01334723|O3|Outcome|Prostate Surgery Outcomes Cohort, MPR <=80%|Participants in the prostate surgery outcomes cohort with an MPR <=80%
268735|NCT01334723|O2|Outcome|Acute Urinary Retention Outcomes Cohort, MPR >80%|Participants in the acute urinary retention outcomes cohort with an >80%
268736|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort, MPR <=80%|Participants in the acute urinary retention outcomes cohort with an MPR <=80%
268737|NCT01334723|O4|Outcome|Prostate Surgery Outcomes Cohort, MPR >75%|Participants in the prostate surgery outcomes cohort with an MPR >75%
268738|NCT01334723|O3|Outcome|Prostate Surgery Outcomes Cohort, MPR <=75%|Participants in the prostate surgery outcomes cohort with an MPR <=75%
268739|NCT01334723|O2|Outcome|Acute Urinary Retention Outcomes Cohort, MPR >75%|Participants in the acute urinary retention outcomes cohort with an MPR >75%
268740|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort, MPR <=75%|Among the Participants in the acute urinary retention outcomes cohort with an MPR <=75%
268741|NCT01334723|O4|Outcome|Prostate Surgery Outocomes Cohort, MPR >70%|Participants in the prostate surgery outcomes cohort with an MPR >70%
268742|NCT01334723|O3|Outcome|Prostate Surgery Outcomes Cohort, MPR <=70%|Participants in the prostate surgery outcomes cohort with an MPR <=70%
268743|NCT01334723|O2|Outcome|Acute Urinary Retention Outcomes Cohort, MPR >70%|Participants in the acute urinary retention outcomes cohort with an MPR >70%
268744|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort, MPR <=70%|Participants in the acute urinary retention outcomes cohort with an MPR <=70%
268745|NCT01334723|E2|Reported Event|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
268746|NCT01334723|E1|Reported Event|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
268747|NCT01334710|B1|Baseline|Sorafenib and OSI-906|"This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.~Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily"
268748|NCT01334710|P1|Participant Flow|Sorafenib and OSI-906|"This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.~Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily"
268749|NCT01334710|O1|Outcome|Sorafenib and OSI-906|"This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.~Sorafenib and OSI-906: Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily"
268750|NCT01334710|O1|Outcome|Sorafenib and OSI-906|"This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.~Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily"
268751|NCT01334710|E1|Reported Event|Sorafenib and OSI-906|"This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.~Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily"
268752|NCT01334606|B1|Baseline|All Study Participants|This includes all subjects randomized to either intervention sequence. Since only 3 subjects completed both study periods, the data are not presented by intervention.
268753|NCT01334606|P1|Participant Flow|All Study Participants|Since only 3 subjects completed both periods of the crossover study before it was prematurely terminated, the primary endpoint analysis could not be performed. Therefore, no tabulations by intervention were prepared.
268754|NCT01334606|O1|Outcome|All Subjects|Due to early termination of the study, only 3 subjects completed both study periods. Analysis of the primary outcome measure requires FRU data from both study periods. Due to the lack of sufficient data, no analysis was performed.
268755|NCT01334606|E3|Reported Event|8mmx31G Pen Needle|Subjects that used the 8mmx31G pen needle, either during Study Period 1 or Study Period 2
268756|NCT01334606|E2|Reported Event|4mmx32G Pen Needle|Subjects that used the 4mmx32G pen needle, either during Study Period 1 or Study Period 2
268757|NCT01334606|E1|Reported Event|All Study Participants|This includes all subjects that participated in the study. A total of 22 adverse events were reported. The investigator reported that 14 of 22 events were not related to the study product, and 8 of 22 events were unlikely related to the study product.
268758|NCT01334554|B3|Baseline|Total|Total of all reporting groups
268759|NCT01334554|B2|Baseline|Placebo|Placebo three times a day for 4 weeks
268760|NCT01334554|B1|Baseline|Sildenafil|Sildenafil 20 mg three times a day for 4 weeks
268761|NCT01334554|P2|Participant Flow|Placebo|Participants received placebo three times a day for 4 weeks
268762|NCT01334554|P1|Participant Flow|Sildenafil|Participants received sildenafil citrate 20 mg three times a day in a fasting condition for 4 weeks
268764|NCT01334554|O1|Outcome|Sildenafil|"Sildenafil 20 mg three times a day~Sildenafil: 20 mg three times a day."
268765|NCT01334554|O2|Outcome|Placebo|Placebo tablets, 1 tablet three times a day
268766|NCT01334554|O1|Outcome|Sildenafil|Sildenafil: 20 mg TID
268767|NCT01334554|E2|Reported Event|Placebo|Participants received placebo three times a day for 4 weeks
268768|NCT01334554|E1|Reported Event|Sildenafil|Participants received sildenafil citrate 20 mg three times a day in a fasting condition for 4 weeks
268769|NCT01334515|B3|Baseline|Total|Total of all reporting groups
268770|NCT01334515|B2|Baseline|Disease Evaluable Only by I-MIBG or BM Histology|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
268771|NCT01334515|B1|Baseline|Disease Measured by Standard Radiographic Criteria|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
268772|NCT01334515|P2|Participant Flow|Disease Evaluable Only by I-MIBG or BM Histology|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
268773|NCT01334515|P1|Participant Flow|Disease Measured by Standard Radiographic Criteria|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
268774|NCT01334515|O2|Outcome|Disease Evaluable Only by I-MIBG or BM Histology|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
268775|NCT01334515|O1|Outcome|Disease Measured by Standard Radiographic Criteria|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
268776|NCT01334515|O2|Outcome|Disease Evaluable Only by I-MIBG or BM Histology|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
268777|NCT01334515|O1|Outcome|Disease Measured by Standard Radiographic Criteria|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
268817|NCT01334125|O2|Outcome|Placebo|"1 capsule once daily by mouth for 9 months~Placebo: 1 capsule once daily by mouth for 9 months"
268778|NCT01334515|E2|Reported Event|Disease Evaluable Only by I-MIBG or BM Histology|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
268779|NCT01334515|E1|Reported Event|Disease Measured by Standard Radiographic Criteria|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
268780|NCT01334229|B3|Baseline|Total|Total of all reporting groups
268781|NCT01334229|B2|Baseline|Placebo First Then Sitagliptin|First intervention: Placebo for 6 weeks Washout: 4 weeks Second intervention: Sitagliptin 100 mg/d for 6 weeks
268782|NCT01334229|B1|Baseline|Sitagliptin First Then Placebo|First intervention: Sitagliptin 100 mg/d for 6 weeks Washout: 4 weeks Second intervention: Pacebo for 6 weeks
268783|NCT01334229|P2|Participant Flow|Placebo First Then Sitagliptin|First intervention: Placebo for 6 weeks Washout: 4 weeks Second intervention: Sitagliptin 100 mg/d for 6 weeks
268784|NCT01334229|P1|Participant Flow|Sitagliptin Then Placebo|First intervention: Sitagliptin 100 mg/d for 6 weeks Washout: 4 weeks Second intervention: Placebo for 6 weeks
268785|NCT01334229|O2|Outcome|Placebo|"Placebo for 6 weeks~Placebo: Placebo for 6 weeks"
268786|NCT01334229|O1|Outcome|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks~Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
268787|NCT01334229|O2|Outcome|Placebo|"Placebo for 6 weeks~Placebo: Placebo for 6 weeks"
268788|NCT01334229|O1|Outcome|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks~Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
268789|NCT01334229|O2|Outcome|Placebo|"Placebo for 6 weeks~Placebo: Placebo for 6 weeks"
268790|NCT01334229|O1|Outcome|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks~Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
268791|NCT01334229|O2|Outcome|Placebo|"Placebo for 6 weeks~Placebo: Placebo for 6 weeks"
268792|NCT01334229|O1|Outcome|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks~Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
268793|NCT01334229|O2|Outcome|Placebo|"Placebo for 6 weeks~Placebo: Placebo for 6 weeks"
268794|NCT01334229|O1|Outcome|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks~Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
268795|NCT01334229|O2|Outcome|Placebo|"Placebo for 6 weeks~Placebo: Placebo for 6 weeks"
268796|NCT01334229|O1|Outcome|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks~Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
268797|NCT01334229|E2|Reported Event|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks~Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
268798|NCT01334229|E1|Reported Event|Placebo|"Placebo for 6 weeks~Placebo: Placebo for 6 weeks"
268799|NCT01334216|B3|Baseline|Total|Total of all reporting groups
268800|NCT01334216|B2|Baseline|CHICA Placebo|"This arm had CHICA without the smoking cessation module~CHICA Placebo: This was CHICA without the study module."
268801|NCT01334216|B1|Baseline|CHICA Smoking Cessation Module|"This arm had the CHICA smoking cessation module turned on~CHICA Smoking Cessation Module: The CHICA module helped to screen parents for smoking and assist them in quitting."
268802|NCT01334216|P2|Participant Flow|CHICA Placebo|"This arm had CHICA without the smoking cessation module~CHICA Placebo: This was CHICA without the study module."
268803|NCT01334216|P1|Participant Flow|CHICA Smoking Cessation Module|"This arm had the CHICA smoking cessation module turned on~CHICA Smoking Cessation Module: The CHICA module helped to screen parents for smoking and assist them in quitting."
268804|NCT01334216|O2|Outcome|CHICA Placebo|"This arm had CHICA without the smoking cessation module~CHICA Placebo: This was CHICA without the study module."
268805|NCT01334216|O1|Outcome|CHICA Smoking Cessation Module|"This arm had the CHICA smoking cessation module turned on~CHICA Smoking Cessation Module: The CHICA module helped to screen parents for smoking and assist them in quitting."
268806|NCT01334216|E2|Reported Event|CHICA Placebo|"This arm had CHICA without the smoking cessation module~CHICA Placebo: This was CHICA without the study module."
268807|NCT01334216|E1|Reported Event|CHICA Smoking Cessation Module|"This arm had the CHICA smoking cessation module turned on~CHICA Smoking Cessation Module: The CHICA module helped to screen parents for smoking and assist them in quitting."
268808|NCT01334125|B3|Baseline|Total|Total of all reporting groups
268809|NCT01334125|B2|Baseline|Placebo|"1 capsule once daily by mouth for 9 months~Placebo: 1 capsules once daily by mouth for 9 months"
268810|NCT01334125|B1|Baseline|Metformin|"Metformin 1000 mg once daily by mouth for 9 months~Metformin: Metformin 1000 mg once daily by mouth for 9 months"
268811|NCT01334125|P2|Participant Flow|Placebo|"1 capsule once daily by mouth for 9 months~Placebo: 1 capsule once daily by mouth for 9 months"
268812|NCT01334125|P1|Participant Flow|Metformin|"Metformin 1000 mg once daily by mouth for 9 months~Metformin: Metformin 1000 mg once daily by mouth for 9 months"
268813|NCT01334125|O2|Outcome|Placebo|"1 capsule once daily by mouth for 9 months~Placebo: 1 capsule once daily by mouth for 9 months"
268814|NCT01334125|O1|Outcome|Metformin|"Metformin 1000 mg once daily by mouth for 9 months~Metformin: Metformin 1000 mg once daily by mouth for 9 months"
268815|NCT01334125|O2|Outcome|Placebo|"1 capsule once daily by mouth for 9 months~Placebo: 1 capsule once daily by mouth for 9 months"
268816|NCT01334125|O1|Outcome|Metformin|"Metformin 1000 mg once daily by mouth for 9 months~Metformin: Metformin 1000 mg once daily by mouth for 9 months"
268941|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
268818|NCT01334125|O1|Outcome|Metformin|"Metformin 1000 mg once daily by mouth for 9 months~Metformin: Metformin 1000 mg once daily by mouth for 9 months"
268819|NCT01334125|O2|Outcome|Placebo|"1 capsule once daily by mouth for 9 months~Placebo: 1 capsules once daily by mouth for 9 months"
268820|NCT01334125|O1|Outcome|Metformin|"Metformin 1000 mg once daily by mouth for 9 months~Metformin: Metformin 1000 mg once daily by mouth for 9 months"
268821|NCT01334125|E2|Reported Event|Placebo|"1 capsule once daily by mouth for 9 months~Placebo: 1 capsule once daily by mouth for 9 months"
268822|NCT01334125|E1|Reported Event|Metformin|"Metformin 1000 mg once daily by mouth for 9 months~Metformin: Metformin 1000 mg once daily by mouth for 9 months"
268823|NCT01333956|B5|Baseline|Total|Total of all reporting groups
268824|NCT01333956|B4|Baseline|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268825|NCT01333956|B3|Baseline|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268826|NCT01333956|B2|Baseline|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268827|NCT01333956|B1|Baseline|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268828|NCT01333956|P4|Participant Flow|150mg Arm|Patients will receive 150mg of pregabalin per dose.
268829|NCT01333956|P3|Participant Flow|100mg Arm|Patients will receive 100mg of pregabalin per dose.
268830|NCT01333956|P2|Participant Flow|50mg Arm|Patients will receive 50mg of pregabalin per dose.
268831|NCT01333956|P1|Participant Flow|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose."
268832|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268833|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268834|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268835|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268836|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268837|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268838|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268839|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268840|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268841|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268842|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268942|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
268943|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
268843|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268844|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268845|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268846|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268847|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268848|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268849|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268850|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268851|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268852|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268853|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268854|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268855|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268856|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268857|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268858|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268859|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of post-operative day (POD)14 and one capsule at bedtime POD15, POD16."
268860|NCT01333956|E4|Reported Event|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268861|NCT01333956|E3|Reported Event|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268944|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
268945|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
268862|NCT01333956|E2|Reported Event|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268863|NCT01333956|E1|Reported Event|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
268864|NCT01333943|B3|Baseline|Total|Total of all reporting groups
268865|NCT01333943|B2|Baseline|Control|"Femoral Nerve Block~Control Group: The control group will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivicaine. The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg)."
268866|NCT01333943|B1|Baseline|Experimental|"Saphenous (Adductor Canal) Nerve Block~Study Group: Experimental: The study group will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivicaine. The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg)."
268867|NCT01333943|P2|Participant Flow|Control|"Femoral Nerve Block~Control Group: The control group will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivicaine. The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg)."
268868|NCT01333943|P1|Participant Flow|Experimental|"Saphenous (Adductor Canal) Nerve Block~Study Group: Experimental: The study group will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivicaine. The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg)."
268869|NCT01333943|O2|Outcome|Control|"Femoral Nerve Block~Control Group: The control group will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivicaine. The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg)."
268870|NCT01333943|O1|Outcome|Experimental|"Saphenous (Adductor Canal) Nerve Block~Study Group: Experimental: The study group will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivicaine. The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg)."
268871|NCT01333943|O2|Outcome|Control|"Femoral Nerve Block~Control Group: The control group will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivicaine. The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg)."
268872|NCT01333943|O1|Outcome|Experimental|"Saphenous (Adductor Canal) Nerve Block~Study Group: Experimental: The study group will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivicaine. The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg)."
268873|NCT01333943|O2|Outcome|Control|"Femoral Nerve Block~Control Group: The control group will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivicaine. The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg)."
268874|NCT01333943|O1|Outcome|Experimental|"Saphenous (Adductor Canal) Nerve Block~Study Group: Experimental: The study group will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivicaine. The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg)."
268875|NCT01333943|O2|Outcome|Control|"Femoral Nerve Block~Control Group: The control group will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivicaine. The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg)."
268876|NCT01333943|O1|Outcome|Experimental|"Saphenous (Adductor Canal) Nerve Block~Study Group: Experimental: The study group will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivicaine. The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg)."
268877|NCT01333943|O2|Outcome|Control|"Femoral Nerve Block~Control Group: The control group will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivicaine. The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg)."
268878|NCT01333943|O1|Outcome|Experimental|"Saphenous (Adductor Canal) Nerve Block~Study Group: Experimental: The study group will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivicaine. The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg)."
268879|NCT01333943|O2|Outcome|Control|"Femoral Nerve Block~Control Group: The control group will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivicaine. The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg)."
268880|NCT01333943|O1|Outcome|Experimental|"Saphenous (Adductor Canal) Nerve Block~Study Group: Experimental: The study group will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivicaine. The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg)."
268881|NCT01333943|E2|Reported Event|Control|"Femoral Nerve Block~Control Group: The control group will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivicaine. The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg)."
268882|NCT01333943|E1|Reported Event|Experimental|"Saphenous (Adductor Canal) Nerve Block~Study Group: Experimental: The study group will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivicaine. The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg)."
268883|NCT01333865|B1|Baseline|Memantine (Namenda) Treatment|"Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer’s disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.~During the 12 weeks of study duration, subjects were evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine was administered in divided dose twice a day in the morning and evening. Titration of study medication was guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects were evaluated."
268884|NCT01333865|P1|Participant Flow|Memantine (Namenda) Treatment|"Memantine: Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer’s disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.~During the 12 weeks of study duration, subjects were evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine was administered in divided dose twice a day in the morning and evening. Titration of study medication was guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects were evaluated."
268885|NCT01333865|O1|Outcome|Memantine (Namenda) Treatment|"Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer’s disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.~During the 12 weeks of study duration, subjects were evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine was administered in divided dose twice a day in the morning and evening. Titration of study medication was guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects were evaluated."
268886|NCT01333865|O1|Outcome|Memantine (Namenda) Treatment|"Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer’s disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.~During the 12 weeks of study duration, subjects were evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine was administered in divided dose twice a day in the morning and evening. Titration of study medication was guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects were evaluated."
268887|NCT01333865|E1|Reported Event|Memantine (Namenda) Treatment|"Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer’s disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.~During the 12 weeks of study duration, subjects were be evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine was administered in divided dose twice a day in the morning and evening. Titration of study medication was guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects were evaluated."
268888|NCT01333813|B1|Baseline|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
268889|NCT01333813|P1|Participant Flow|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
268890|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
268891|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
268892|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
268893|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
268894|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
268895|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
268896|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
268897|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
268898|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
268899|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
268900|NCT01333813|E1|Reported Event|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
268901|NCT01333722|B3|Baseline|Total|Total of all reporting groups
268902|NCT01333722|B2|Baseline|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
268903|NCT01333722|B1|Baseline|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
268904|NCT01333722|P2|Participant Flow|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
268905|NCT01333722|P1|Participant Flow|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
268906|NCT01333722|O2|Outcome|Placebo|placebo, 1 oral tablet every 12 hours
268907|NCT01333722|O1|Outcome|Hydrocodone/Acetaminophen Extended Release|hydrocodone/acetaminophen extended release, 1 oral tablet every 12 hours
268908|NCT01333722|O2|Outcome|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
268909|NCT01333722|O1|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
268910|NCT01333722|O2|Outcome|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
268911|NCT01333722|O1|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
268912|NCT01333722|O2|Outcome|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
268913|NCT01333722|O1|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
268914|NCT01333722|E2|Reported Event|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
268915|NCT01333722|E1|Reported Event|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
268916|NCT01333592|B3|Baseline|Total|Total of all reporting groups
268917|NCT01333592|B2|Baseline|KAD-1229 / Biguanides|
268918|NCT01333592|B1|Baseline|KAD-1229 / DPP-4 Inhibitors|
268919|NCT01333592|P2|Participant Flow|KAD-1229 / Biguanides|
268920|NCT01333592|P1|Participant Flow|KAD-1229 / DPP-4 Inhibitors|
268921|NCT01333592|O2|Outcome|KAD-1229 / Biguanides|
268922|NCT01333592|O1|Outcome|KAD-1229 / DPP-4 Inhibitors|
268923|NCT01333592|O2|Outcome|KAD-1229 / Biguanides|
268924|NCT01333592|O1|Outcome|KAD-1229 / DPP-4 Inhibitors|
268925|NCT01333592|E2|Reported Event|KAD-1229 / Biguanides|
268926|NCT01333592|E1|Reported Event|KAD-1229 / DPP-4 Inhibitors|
268927|NCT01333501|B3|Baseline|Total|Total of all reporting groups
268928|NCT01333501|B2|Baseline|Interferon Beta 1b|250 μg injected s.c. every other day
268929|NCT01333501|B1|Baseline|Fingolimod|0.5 mg in capsules for oral administration once daily
268930|NCT01333501|P2|Participant Flow|Interferon Beta 1b|250 μg injected s.c. every other day
268931|NCT01333501|P1|Participant Flow|Fingolimod|0.5 mg in capsules for oral administration once daily
268932|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
268933|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
268934|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
268935|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
268936|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
268937|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
268938|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
268939|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
268940|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
269052|NCT01333397|O2|Outcome|Dysport NG 20 U|
268946|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
268947|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
268948|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
268949|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
268950|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
268951|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
268952|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
268953|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
268954|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
268955|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
268956|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
268957|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
268958|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
268959|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
268960|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
268961|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
268962|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
268963|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
268964|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
268965|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
268966|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
268967|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
268968|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
268969|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
268970|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
268971|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
268972|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
268973|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
268974|NCT01333501|E2|Reported Event|Interferon Beta 1b|250 μg injected s.c. every other day
268975|NCT01333501|E1|Reported Event|Fingolimod 0.5 mg|0.5 mg in capsules for oral administration once daily
268976|NCT01333488|B4|Baseline|Total|Total of all reporting groups
268977|NCT01333488|B3|Baseline|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.~Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
268978|NCT01333488|B2|Baseline|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.~Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
268979|NCT01333488|B1|Baseline|Conventional Therapy|Standard of care therapy for severe traumatic brain injury.
268980|NCT01333488|P3|Participant Flow|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.~Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
268981|NCT01333488|P2|Participant Flow|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.~Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
268982|NCT01333488|P1|Participant Flow|Conventional Therapy|Standard of Care treatment for severe traumatic brain injury.
268983|NCT01333488|O3|Outcome|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.~Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
268984|NCT01333488|O2|Outcome|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.~Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
268985|NCT01333488|O1|Outcome|Conventional Therapy|Standard of care therapy for severe traumatic brain injury.
268986|NCT01333488|O3|Outcome|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.~Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
268987|NCT01333488|O2|Outcome|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.~Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
268988|NCT01333488|O1|Outcome|Conventional Therapy|Standard of Care treatment for severe traumatic brain injury.
268989|NCT01333488|O3|Outcome|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.~Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
268990|NCT01333488|O2|Outcome|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.~Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
268991|NCT01333488|O1|Outcome|Conventional Therapy|Standard of Care treatment for severe traumatic brain injury.
269053|NCT01333397|O1|Outcome|Placebo|
269054|NCT01333397|O5|Outcome|Dysport 50 U|
269055|NCT01333397|O4|Outcome|Dysport NG 75 U|
268992|NCT01333488|E3|Reported Event|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.~Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
268993|NCT01333488|E2|Reported Event|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.~Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
268994|NCT01333488|E1|Reported Event|Conventional Therapy|Standard of care therapy for severe traumatic brain injury.
268995|NCT01333475|B3|Baseline|Total|Total of all reporting groups
268996|NCT01333475|B2|Baseline|TAC1A|"Cycle = 28 days:MK-2206: 135 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
268997|NCT01333475|B1|Baseline|TAC1|"Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
268998|NCT01333475|P2|Participant Flow|TAC1A|"Cycle = 28 days:MK-2206:135 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
268999|NCT01333475|P1|Participant Flow|TAC1|"Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
269000|NCT01333475|O2|Outcome|TAC1A|"Cycle = 28 days:MK-2206: 135 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
269001|NCT01333475|O1|Outcome|TAC1|"Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
269002|NCT01333475|O2|Outcome|TAC1A|"Cycle = 28 days:MK-2206: 135mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
269003|NCT01333475|O1|Outcome|TAC1|"Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
269004|NCT01333475|E2|Reported Event|TAC1A|"Cycle = 28 days:MK-2206: 135 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
269005|NCT01333475|E1|Reported Event|TAC1|"Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
269006|NCT01333436|B3|Baseline|Total|Total of all reporting groups
269007|NCT01333436|B2|Baseline|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal ( 57% fat, 31% carbohydrate, and 12% protein).
269008|NCT01333436|B1|Baseline|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein.
269009|NCT01333436|P2|Participant Flow|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
269010|NCT01333436|P1|Participant Flow|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
269011|NCT01333436|O2|Outcome|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
269012|NCT01333436|O1|Outcome|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
269013|NCT01333436|O2|Outcome|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
269014|NCT01333436|O1|Outcome|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
269015|NCT01333436|O2|Outcome|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
269016|NCT01333436|O1|Outcome|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
269017|NCT01333436|E2|Reported Event|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
269018|NCT01333436|E1|Reported Event|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
269019|NCT01333397|B6|Baseline|Total|Total of all reporting groups
269020|NCT01333397|B5|Baseline|Dysport 50 U|Botulinum type A toxin (Azzalure), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
269021|NCT01333397|B4|Baseline|Dysport NG 75 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
269022|NCT01333397|B3|Baseline|Dysport NG 50 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
269023|NCT01333397|B2|Baseline|Dysport NG 20 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
269024|NCT01333397|B1|Baseline|Placebo|Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
269025|NCT01333397|P5|Participant Flow|Dysport 50 U|Botulinum type A toxin (Azzalure), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
269026|NCT01333397|P4|Participant Flow|Dysport NG 75 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
269027|NCT01333397|P3|Participant Flow|Dysport NG 50 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
269028|NCT01333397|P2|Participant Flow|Dysport NG 20 U|"Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)~Ready to Use (RU)"
269029|NCT01333397|P1|Participant Flow|Placebo|Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
269030|NCT01333397|O2|Outcome|Dysport 50 U|
269031|NCT01333397|O1|Outcome|Placebo|
269032|NCT01333397|O4|Outcome|Dysport 50 U|
269033|NCT01333397|O3|Outcome|Dysport NG 75 U|
269034|NCT01333397|O2|Outcome|Dysport NG 50 U|
269035|NCT01333397|O1|Outcome|Dysport NG 20 U|
269036|NCT01333397|O4|Outcome|Dysport 50 U|
269037|NCT01333397|O3|Outcome|Dysport NG 75 U|
269038|NCT01333397|O2|Outcome|Dysport NG 50 U|
269039|NCT01333397|O1|Outcome|Dysport NG 20 U|
269040|NCT01333397|O4|Outcome|Dysport 50 U|
269041|NCT01333397|O3|Outcome|Dysport NG 75 U|
269042|NCT01333397|O2|Outcome|Dysport NG 50 U|
269043|NCT01333397|O1|Outcome|Dysport NG 20 U|
269044|NCT01333397|O5|Outcome|Dysport 50 U|
269045|NCT01333397|O4|Outcome|Dysport NG 75 U|
269046|NCT01333397|O3|Outcome|Dysport NG 50 U|
269047|NCT01333397|O2|Outcome|Dysport NG 20 U|
269048|NCT01333397|O1|Outcome|Placebo|
269049|NCT01333397|O5|Outcome|Dysport 50 U|
269050|NCT01333397|O4|Outcome|Dysport NG 75 U|
269051|NCT01333397|O3|Outcome|Dysport NG 50 U|
269091|NCT01333397|O4|Outcome|Dysport NG 75 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
269092|NCT01333397|O3|Outcome|Dysport NG 50 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
269093|NCT01333397|O2|Outcome|Dysport NG 20 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
269094|NCT01333397|O1|Outcome|Placebo|Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
269095|NCT01333397|E5|Reported Event|Dysport 50 U|Botulinum type A toxin ((Azzalure), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
269096|NCT01333397|E4|Reported Event|Dysport NG 75 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
269097|NCT01333397|E3|Reported Event|Dysport NG 50 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
269098|NCT01333397|E2|Reported Event|Dysport NG 20 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
269099|NCT01333397|E1|Reported Event|Placebo|Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
269100|NCT01333189|B3|Baseline|Total|Total of all reporting groups
269101|NCT01333189|B2|Baseline|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
269102|NCT01333189|B1|Baseline|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
269103|NCT01333189|P2|Participant Flow|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
269104|NCT01333189|P1|Participant Flow|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
269105|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
269638|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
290466|NCT01271036|O1|Outcome|Male|Male Participants
269106|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
269107|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
269108|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
269109|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
269110|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
269111|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
269112|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
269113|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
269145|NCT01333111|O2|Outcome|Prophylaxis, High Dose 40 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 40 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269644|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
269114|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
269115|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
269116|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
269117|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
269118|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
269119|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
269120|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
269121|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
269146|NCT01333111|O1|Outcome|Prophylaxis, Low Dose 10 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 10 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269682|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
290467|NCT01271036|O2|Outcome|Female|Female Participants
269122|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
269123|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
269124|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
269125|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
269126|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
269127|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
269128|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
269129|NCT01333189|E2|Reported Event|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
269147|NCT01333111|O2|Outcome|Prophylaxis, High Dose 40 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 40 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269683|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269130|NCT01333189|E1|Reported Event|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
269131|NCT01333111|B4|Baseline|Total|Total of all reporting groups
269132|NCT01333111|B3|Baseline|On-Demand (28 Weeks)|Subjects enrolled in this on-demand arm were treated for bleeding episodes on demand with nonacog beta pegol during a period of 28 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269133|NCT01333111|B2|Baseline|Prophylaxis, High Dose 40 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 40 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269134|NCT01333111|B1|Baseline|Prophylaxis, Low Dose 10 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 10 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269135|NCT01333111|P3|Participant Flow|On-Demand (28 Weeks)|Subjects enrolled in this on-demand arm were treated for bleeding episodes on demand with nonacog beta pegol during a period of 28 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269136|NCT01333111|P2|Participant Flow|Prophylaxis, High Dose 40 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 40 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269137|NCT01333111|P1|Participant Flow|Prophylaxis, Low Dose 10 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 10 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269138|NCT01333111|O1|Outcome|On-Demand (28 Weeks)|Subjects enrolled in this on-demand arm were treated for bleeding episodes on demand with nonacog beta pegol during a period of 28 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269139|NCT01333111|O2|Outcome|Prophylaxis, High Dose 40 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 40 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269140|NCT01333111|O1|Outcome|Prophylaxis, Low Dose 10 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 10 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269141|NCT01333111|O1|Outcome|On-Demand (28 Weeks)|Subjects enrolled in this on-demand arm were treated for bleeding episodes on demand with nonacog beta pegol during a period of 28 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269142|NCT01333111|O2|Outcome|Prophylaxis, High Dose 40 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 40 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269143|NCT01333111|O1|Outcome|Prophylaxis, Low Dose 10 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 10 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269144|NCT01333111|O1|Outcome|On-Demand (28 Weeks)|Subjects enrolled in this on-demand arm were treated for bleeding episodes on demand with nonacog beta pegol during a period of 28 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269224|NCT01332981|O1|Outcome|Transtuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
290468|NCT01271036|O1|Outcome|Male|Male Participants
269148|NCT01333111|O1|Outcome|Prophylaxis, Low Dose 10 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 10 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269149|NCT01333111|O2|Outcome|Prophylaxis, High Dose 40 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 40 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269150|NCT01333111|O1|Outcome|Prophylaxis, Low Dose 10 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 10 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269151|NCT01333111|O1|Outcome|On-Demand (28 Weeks)|Subjects enrolled in this on-demand arm were treated for bleeding episodes on demand with nonacog beta pegol during a period of 28 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269152|NCT01333111|O2|Outcome|Prophylaxis, High Dose 40 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 40 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269153|NCT01333111|O1|Outcome|Prophylaxis, Low Dose 10 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 10 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269154|NCT01333111|O1|Outcome|On-Demand (28 Weeks)|Subjects enrolled in this on-demand arm were treated for bleeding episodes on demand with nonacog beta pegol during a period of 28 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269155|NCT01333111|O2|Outcome|Prophylaxis, High Dose 40 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 40 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269156|NCT01333111|O1|Outcome|Prophylaxis, Low Dose 10 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 10 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269157|NCT01333111|E3|Reported Event|On-Demand (28 Weeks)|Subjects enrolled in this on-demand arm were treated for bleeding episodes on demand with nonacog beta pegol during a period of 28 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269158|NCT01333111|E2|Reported Event|Prophylaxis, High Dose 40 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 40 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269159|NCT01333111|E1|Reported Event|Prophylaxis, Low Dose 10 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 10 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
269160|NCT01332994|B1|Baseline|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269161|NCT01332994|P1|Participant Flow|Tocilizumab (TCZ)/TCZ or TCZ/Rituximab (RTX)|All participants were assigned to receive TCZ 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using Disease Activity Score Based on 28-Joint Count (DAS28) to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of less than (<) 2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score greater than (>) 1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score less than or equal to (≤) 1.2 or a score >3.2, received RTX 1000 milligrams (mg) via IV infusion at Weeks 16 and 18.
269162|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269163|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269164|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269165|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269166|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269167|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269168|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269169|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269225|NCT01332981|O1|Outcome|Transtuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
269226|NCT01332981|E1|Reported Event|Trastuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
269170|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269171|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269172|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269173|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269174|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269175|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269176|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269177|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269227|NCT01332968|B3|Baseline|Total|Total of all reporting groups
269228|NCT01332968|B2|Baseline|Obinutuzumab+Chemotherapy - Induction Period|Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
269684|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269178|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269179|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269180|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269181|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269182|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269183|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269184|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269185|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269229|NCT01332968|B1|Baseline|Rituximab+Chemotherapy - Induction Period|Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
269230|NCT01332968|P8|Participant Flow|Obinutuzumab+Chemotherapy - Follow-Up Period|Finally, participants were followed during a 5-year follow-up period.
269186|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269187|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269188|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269189|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269190|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269191|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269192|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269193|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269231|NCT01332968|P7|Participant Flow|Rituximab+Chemotherapy - Follow-Up Period|Finally, participants were followed during a 5-year follow-up period.
269232|NCT01332968|P6|Participant Flow|Obinutuzumab+Chemotherapy - Observation Period|Obinutuzumab+Chemotherapy – Observation: The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Non-responders received no protocol specified treatment during the 2-year observation period.
269639|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
269194|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269195|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269196|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269197|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269198|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269199|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269200|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269201|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269233|NCT01332968|P5|Participant Flow|Rituximab+Chemotherapy - Observation Period|Rituximab+Chemotherapy – Observation: The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Non-responders received no protocol specified treatment during the 2-year observation period.
269234|NCT01332968|P4|Participant Flow|Obinutuzumab+Chemotherapy - Maintenance Period|The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period.
290469|NCT01271036|E2|Reported Event|Female|Female Participants
269202|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269203|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269204|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269205|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269206|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269207|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269208|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269209|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269235|NCT01332968|P3|Participant Flow|Rituximab+Chemotherapy - Maintenance Period|The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period.
269396|NCT01332435|O4|Outcome|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269210|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269211|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269212|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269213|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269214|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269215|NCT01332994|E1|Reported Event|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
269216|NCT01332981|B1|Baseline|Transtuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
269217|NCT01332981|P1|Participant Flow|Trastuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
269218|NCT01332981|O2|Outcome|Model 2|In the second one (Model 2), a stepwise selection was used on the significant parameters that were not correlated. The significance level for entry was 10% and the significance level for removal was 5%.
269219|NCT01332981|O1|Outcome|Model 1|In the first one (Model 1), a stepwise selection method was used on all parameters that were significant in the univariate analyses, whatever the significance level of the associations between parameters.
269220|NCT01332981|O2|Outcome|Model 2|In the second one (Model 2), a stepwise selection was used on the significant parameters that were not correlated. The significance level for entry was 10% and the significance level for removal was 5%.
269221|NCT01332981|O1|Outcome|Model 1|In the first one (Model 1), a stepwise selection method was used on all parameters that were significant in the univariate analyses, whatever the significance level of the associations between parameters.
269222|NCT01332981|O1|Outcome|Trastuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
269223|NCT01332981|O1|Outcome|Transtuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
269236|NCT01332968|P2|Participant Flow|Obinutuzumab+Chemotherapy - Induction Period|Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
269237|NCT01332968|P1|Participant Flow|Rituximab+Chemotherapy - Induction Period|Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
269238|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269239|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269240|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269241|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269242|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269243|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269244|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
269323|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
269245|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
269246|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
269247|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
269248|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
269249|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
269250|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
269251|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
269252|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269324|NCT01332578|E2|Reported Event|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
269325|NCT01332578|E1|Reported Event|Hot Drink Remedy|Participants then received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid, which was dissolved in 150 mL of radio-labeled water.
269253|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269254|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269255|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269256|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269257|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269258|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269259|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269260|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269326|NCT01332500|B5|Baseline|Total|Total of all reporting groups
269640|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
290470|NCT01271036|E1|Reported Event|Male|Male Participants
269261|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269262|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269263|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269264|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269265|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269266|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269267|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269268|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269375|NCT01332435|B5|Baseline|Total|Total of all reporting groups
269641|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
269269|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269270|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269271|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269272|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269273|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269274|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269275|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269276|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269579|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269277|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269278|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269279|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269280|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269281|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269282|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269283|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269284|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269580|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269285|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269286|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269287|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269288|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269289|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269290|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269291|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269292|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269581|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269293|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269294|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269295|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269296|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269297|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269298|NCT01332968|E2|Reported Event|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269299|NCT01332968|E1|Reported Event|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
269300|NCT01332721|B1|Baseline|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
269376|NCT01332435|B4|Baseline|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269685|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269301|NCT01332721|P1|Participant Flow|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
269302|NCT01332721|O1|Outcome|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
269303|NCT01332721|O1|Outcome|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
269304|NCT01332721|O1|Outcome|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
269305|NCT01332721|E1|Reported Event|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
269306|NCT01332578|B1|Baseline|All Randomized Participants|All randomized participants who received a study treatment during the cross over study.
269307|NCT01332578|P2|Participant Flow|Standard Paracetamol Tablets First, Then Hot Drink Remedy|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water (first intervention period). After a washout period of minimum two days, one sachet of hot drink remedy with 150 mL of radio-labeled water was administered (second intervention period).
269308|NCT01332578|P1|Participant Flow|Hot Drink Remedy First, Then Standard Paracetamol Tablets|Participants received one sachet of hot drink remedy containing 1000 milligram (mg) paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid in 150 milliliter (mL) of radio-labeled water (first intervention period). After a washout period of minimum two days, a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL water were administered (second intervention period).
269309|NCT01332578|O1|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
269310|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
269311|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
269312|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
269313|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
269314|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
269315|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
269316|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
269317|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
269318|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
269319|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
269320|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
269321|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
269322|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
269327|NCT01332500|B4|Baseline|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
269328|NCT01332500|B3|Baseline|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
269329|NCT01332500|B2|Baseline|Naïve - Oral Triptan|"Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan.~Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics."
269330|NCT01332500|B1|Baseline|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
269331|NCT01332500|P4|Participant Flow|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
269332|NCT01332500|P3|Participant Flow|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
269333|NCT01332500|P2|Participant Flow|Naïve - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan.
269334|NCT01332500|P1|Participant Flow|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
269335|NCT01332500|O2|Outcome|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
269336|NCT01332500|O1|Outcome|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
269377|NCT01332435|B3|Baseline|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269642|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
269337|NCT01332500|O2|Outcome|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
269338|NCT01332500|O1|Outcome|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
269339|NCT01332500|O2|Outcome|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
269340|NCT01332500|O1|Outcome|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
269341|NCT01332500|O2|Outcome|Naïve - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
269342|NCT01332500|O1|Outcome|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
269343|NCT01332500|O2|Outcome|Naïve - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
269344|NCT01332500|O1|Outcome|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
269345|NCT01332500|O2|Outcome|Naïve - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
269346|NCT01332500|O1|Outcome|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
269378|NCT01332435|B2|Baseline|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269643|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
269347|NCT01332500|E4|Reported Event|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
269348|NCT01332500|E3|Reported Event|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
269349|NCT01332500|E2|Reported Event|Naïve - Oral Triptan|"Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan.~Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics."
269350|NCT01332500|E1|Reported Event|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
269351|NCT01332487|B3|Baseline|Total|Total of all reporting groups
269352|NCT01332487|B2|Baseline|Delayed Treatment|Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
269353|NCT01332487|B1|Baseline|Early Treatment|Participants who started 5ARI therapy within 30 days of initiating AB treatment
269354|NCT01332487|P2|Participant Flow|Delayed Treatment|Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
269355|NCT01332487|P1|Participant Flow|Early Treatment|Participants who started 5-alpha-reductase inhibitor (5ARI) therapy within 30 days of initiating alpha-blocker (AB) treatment
269356|NCT01332487|O2|Outcome|Delayed Treatment|Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
269357|NCT01332487|O1|Outcome|Early Treatment|Participants who started 5ARI therapy within 30 days of initiating AB treatment
269358|NCT01332487|O2|Outcome|Delayed Treatment|Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
269359|NCT01332487|O1|Outcome|Early Treatment|Participants who started 5ARI therapy within 30 days of initiating AB treatment
269360|NCT01332487|E2|Reported Event|Delayed Treatment|Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
269361|NCT01332487|E1|Reported Event|Early Treatment|Participants who started 5ARI therapy within 30 days of initiating AB treatment
269362|NCT01332461|B3|Baseline|Total|Total of all reporting groups
269363|NCT01332461|B2|Baseline|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
269364|NCT01332461|B1|Baseline|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
269365|NCT01332461|P2|Participant Flow|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
269366|NCT01332461|P1|Participant Flow|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
269367|NCT01332461|O2|Outcome|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
269368|NCT01332461|O1|Outcome|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
269369|NCT01332461|O2|Outcome|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
269370|NCT01332461|O1|Outcome|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
269371|NCT01332461|O2|Outcome|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
269372|NCT01332461|O1|Outcome|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
269373|NCT01332461|E2|Reported Event|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
269374|NCT01332461|E1|Reported Event|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
269379|NCT01332435|B1|Baseline|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
269380|NCT01332435|P4|Participant Flow|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269381|NCT01332435|P3|Participant Flow|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269382|NCT01332435|P2|Participant Flow|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269383|NCT01332435|P1|Participant Flow|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
269384|NCT01332435|O4|Outcome|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269385|NCT01332435|O3|Outcome|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269386|NCT01332435|O2|Outcome|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269387|NCT01332435|O1|Outcome|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
269388|NCT01332435|O4|Outcome|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269389|NCT01332435|O3|Outcome|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269390|NCT01332435|O2|Outcome|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269391|NCT01332435|O1|Outcome|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
269392|NCT01332435|O4|Outcome|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269393|NCT01332435|O3|Outcome|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269394|NCT01332435|O2|Outcome|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269395|NCT01332435|O1|Outcome|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
269582|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269397|NCT01332435|O3|Outcome|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269398|NCT01332435|O2|Outcome|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269399|NCT01332435|O1|Outcome|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
269400|NCT01332435|O4|Outcome|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269401|NCT01332435|O3|Outcome|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269402|NCT01332435|O2|Outcome|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269403|NCT01332435|O1|Outcome|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
269404|NCT01332435|O4|Outcome|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269405|NCT01332435|O3|Outcome|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269406|NCT01332435|O2|Outcome|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269407|NCT01332435|O1|Outcome|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
269408|NCT01332435|E4|Reported Event|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269409|NCT01332435|E3|Reported Event|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269410|NCT01332435|E2|Reported Event|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
269411|NCT01332435|E1|Reported Event|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
269412|NCT01332357|B1|Baseline|Total Population|Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
269413|NCT01332357|P1|Participant Flow|Total Population|Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
269414|NCT01332357|O1|Outcome|Total Population|Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
269415|NCT01332357|E1|Reported Event|Total Population|Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
269416|NCT01332318|B5|Baseline|Total|Total of all reporting groups
269417|NCT01332318|B4|Baseline|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269418|NCT01332318|B3|Baseline|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269419|NCT01332318|B2|Baseline|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269420|NCT01332318|B1|Baseline|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269421|NCT01332318|P4|Participant Flow|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269422|NCT01332318|P3|Participant Flow|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269423|NCT01332318|P2|Participant Flow|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269424|NCT01332318|P1|Participant Flow|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269425|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269426|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269427|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269428|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269429|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269430|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269431|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269583|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269432|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269433|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269434|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269435|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269436|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269437|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269438|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269439|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269440|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269441|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269442|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269443|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269444|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269445|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269446|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
290549|NCT01270841|B5|Baseline|Total|Total of all reporting groups
269447|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269448|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269449|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269450|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269451|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269452|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269453|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269454|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269455|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269456|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269457|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269458|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269459|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269460|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269461|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
271460|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
269462|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269463|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269464|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269465|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269466|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269467|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269468|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269469|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269470|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269471|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269472|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269473|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269474|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269475|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269476|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269477|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
292006|NCT01265667|O1|Outcome|CF101 2 mg|CF101: orally q12h
269478|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269479|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269480|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269481|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269482|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269483|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269484|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269485|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269486|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269487|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269488|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269489|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269490|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269491|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269492|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269493|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
292007|NCT01265667|O2|Outcome|Placebo|Placebo: orally q12h
269494|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269495|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269496|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269497|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269498|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269499|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269500|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269501|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269502|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269503|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269504|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269505|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269506|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269507|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269508|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269509|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
292008|NCT01265667|O1|Outcome|CF101 2 mg|CF101: orally q12h
269510|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269511|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269512|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269513|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269514|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269515|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269516|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269517|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269518|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269519|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269520|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269521|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269522|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269523|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269524|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269525|NCT01332318|E4|Reported Event|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269526|NCT01332318|E3|Reported Event|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269527|NCT01332318|E2|Reported Event|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
269528|NCT01332318|E1|Reported Event|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
269529|NCT01332305|B6|Baseline|Total|Total of all reporting groups
269530|NCT01332305|B5|Baseline|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
269531|NCT01332305|B4|Baseline|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
269532|NCT01332305|B3|Baseline|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
269533|NCT01332305|B2|Baseline|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
269534|NCT01332305|B1|Baseline|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
269535|NCT01332305|P5|Participant Flow|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
269536|NCT01332305|P4|Participant Flow|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
269537|NCT01332305|P3|Participant Flow|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
269538|NCT01332305|P2|Participant Flow|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
269539|NCT01332305|P1|Participant Flow|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
269540|NCT01332305|O5|Outcome|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
269541|NCT01332305|O4|Outcome|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
269584|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269542|NCT01332305|O3|Outcome|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
269543|NCT01332305|O2|Outcome|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
269544|NCT01332305|O1|Outcome|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
269545|NCT01332305|O5|Outcome|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
269546|NCT01332305|O4|Outcome|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
269547|NCT01332305|O3|Outcome|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
269548|NCT01332305|O2|Outcome|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
269549|NCT01332305|O1|Outcome|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
269550|NCT01332305|O5|Outcome|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
269551|NCT01332305|O4|Outcome|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
269552|NCT01332305|O3|Outcome|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
269553|NCT01332305|O2|Outcome|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
269554|NCT01332305|O1|Outcome|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
269555|NCT01332305|E5|Reported Event|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
269556|NCT01332305|E4|Reported Event|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
269557|NCT01332305|E3|Reported Event|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
269558|NCT01332305|E2|Reported Event|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
269559|NCT01332305|E1|Reported Event|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
269560|NCT01332292|B1|Baseline|FF 100 µg/Placebo or Placebo/FF 100 µg|Participants received either fluticasone furoate (FF) 100 micrograms (µg) or matching placebo in the first of two 14-day treatment periods, followed by the other therapy (the therapy not received in the first treatment period) in the second 14-day treatment period. Inhaled FF 100 µg or matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269561|NCT01332292|P2|Participant Flow|Sequence 2: Placebo Followed by FF 100 µg|Participants received placebo in Treatment Period 1 and FF 100 µg in Treatment Period 2. Inhaled FF 100 µg and matching placebo were administered once daily in the morning (Day 1 to Day 14) via a Dry Powder Inhaler. The washout period between the 14-day treatment periods was at least 7 days.
269562|NCT01332292|P1|Participant Flow|Sequence 1: FF 100 µg Followed by Placebo|Participants received fluticasone furoate (FF) 100 micrograms (µg) in Treatment Period 1 and matching placebo in Treatment Period 2. Inhaled FF 100 µg and matching placebo were administered once daily in the morning (Day 1 to Day 14) via a Dry Powder Inhaler. The washout period between the 14-day treatment periods was at least 7 days.
269563|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269564|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269565|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269566|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269567|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269568|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269569|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269570|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269571|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269572|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269573|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269574|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269575|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269576|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269577|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269578|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269686|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269585|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269586|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269587|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269588|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269589|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269590|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269591|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269592|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269593|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269594|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269595|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269596|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269597|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269598|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269599|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269600|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269601|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269602|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269603|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269604|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269605|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269606|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269607|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269637|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
269608|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269609|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269610|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269611|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269612|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269613|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Novel Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269614|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Novel Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269615|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269616|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269617|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269618|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269619|NCT01332292|E2|Reported Event|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269620|NCT01332292|E1|Reported Event|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
269621|NCT01332253|B3|Baseline|Total|Total of all reporting groups
269622|NCT01332253|B2|Baseline|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
269623|NCT01332253|B1|Baseline|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
269624|NCT01332253|P2|Participant Flow|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
269625|NCT01332253|P1|Participant Flow|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
269626|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
269627|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
269628|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
269629|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
269630|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
269631|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
269632|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
269633|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
269634|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
269635|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
269636|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
269645|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
269646|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
269647|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
269648|NCT01332253|E2|Reported Event|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
269649|NCT01332253|E1|Reported Event|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
269650|NCT01332227|B3|Baseline|Total|Total of all reporting groups
269651|NCT01332227|B2|Baseline|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
269652|NCT01332227|B1|Baseline|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
269653|NCT01332227|P2|Participant Flow|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
269654|NCT01332227|P1|Participant Flow|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
269655|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
269656|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
269657|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
269658|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
269659|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
269660|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
269661|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
269662|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
269663|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
269664|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
269665|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
269666|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
269667|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
269668|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
269669|NCT01332227|E2|Reported Event|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
269670|NCT01332227|E1|Reported Event|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
269671|NCT01332188|B5|Baseline|Total|Total of all reporting groups
269672|NCT01332188|B4|Baseline|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269673|NCT01332188|B3|Baseline|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269674|NCT01332188|B2|Baseline|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269675|NCT01332188|B1|Baseline|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269676|NCT01332188|P4|Participant Flow|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269677|NCT01332188|P3|Participant Flow|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269678|NCT01332188|P2|Participant Flow|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269679|NCT01332188|P1|Participant Flow|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269680|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269681|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269687|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269688|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269689|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269690|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269691|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269692|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269693|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269694|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269695|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269696|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269697|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269698|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269699|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269700|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269701|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269702|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269703|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269704|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269705|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269706|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269707|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269708|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269709|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269710|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269711|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269712|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269713|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269714|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269715|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269716|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269717|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269718|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269719|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269720|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269721|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269722|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269723|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269724|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269725|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269726|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269727|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269728|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269729|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269730|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269731|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269732|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269733|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269734|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269735|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269736|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269737|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269738|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269739|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269740|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269741|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
271461|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
269742|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269743|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269744|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269745|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269746|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269747|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269748|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269749|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269750|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269751|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269752|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269753|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269754|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269755|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269756|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269757|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269758|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269759|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269760|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269761|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269762|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269763|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269764|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269765|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269766|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269767|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269768|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269769|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269770|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269771|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269772|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269773|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269774|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269775|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269776|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269777|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269778|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269779|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269780|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269781|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269782|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269783|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269784|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269785|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269786|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269787|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269788|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269789|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269790|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269791|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269792|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269793|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269794|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269795|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269796|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
271462|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
269797|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269798|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269799|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269800|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269801|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269802|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269803|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269804|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269805|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269806|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269807|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269808|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269809|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269810|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269811|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269812|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269813|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269814|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269815|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269816|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269817|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269818|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269819|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269820|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269821|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269822|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269823|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269824|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269825|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269826|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269827|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269828|NCT01332188|E4|Reported Event|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
269829|NCT01332188|E3|Reported Event|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
269830|NCT01332188|E2|Reported Event|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
269831|NCT01332188|E1|Reported Event|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
269832|NCT01332149|B3|Baseline|Total|Total of all reporting groups
269833|NCT01332149|B2|Baseline|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269834|NCT01332149|B1|Baseline|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269835|NCT01332149|P2|Participant Flow|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269836|NCT01332149|P1|Participant Flow|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269837|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269838|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269839|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269840|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269841|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269842|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269843|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269844|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269845|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269846|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269847|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269848|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269849|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269850|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269851|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269852|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269853|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269854|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269855|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269856|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269857|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269937|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269938|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
271463|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
269858|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269859|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269860|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269861|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269862|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269863|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269864|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269865|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269866|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269867|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269868|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269869|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269870|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269871|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269872|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269873|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269874|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269875|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269939|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269940|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
271464|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
269876|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269877|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269878|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269879|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269880|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269881|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269882|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269883|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269884|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269885|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269886|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269887|NCT01332149|E2|Reported Event|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
269888|NCT01332149|E1|Reported Event|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
269889|NCT01332123|B1|Baseline|Alignment Perturbations|"The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation, increased foot outward rotation, increased foot inward rotation (always 15 degrees from the neutral position)~Alignment perturbations: Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation, increased foot outward rotation, increased foot inward rotation (always 15 degrees from the neutral position)"
269890|NCT01332123|P1|Participant Flow|Alignment Perturbations|"The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation, increased foot outward rotation, increased foot inward rotation (always 15 degrees from the neutral position)~Alignment perturbations: Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation, increased foot outward rotation, increased foot inward rotation (always 15 degrees from the neutral position)"
269891|NCT01332123|O1|Outcome|Alignment Perturbations|"The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)~Alignment perturbations: Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)"
269892|NCT01332123|O1|Outcome|Alignment Perturbations|"The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)~All participants were subjected to the same 5 interventions (neutral alignment and 4 perturbations as detailed above) in sequence to allow repeated measures (within-subject) comparisons."
269941|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269893|NCT01332123|E1|Reported Event|Alignment Perturbations|"The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)~Alignment perturbations: Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)"
269894|NCT01332071|B1|Baseline|Participants Receiving Both Test and Reference Product|Participants receiving either test product: Avandamet 4 mg + 1000 mg in Period 1; followed by reference product: Avandamet 2 mg + 500 mg in Period 2 or reference product in Period 1 and test product in Period 2
269895|NCT01332071|P2|Participant Flow|Reference Product in Period 1; Test Product in Period 2|Reference product: Avandamet 2 mg + 500 mg in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: Avandamet 4 mg + 1000 mg in Period 2
269896|NCT01332071|P1|Participant Flow|Test Product in Period 1; Reference Product in Period 2|Test product: Rosiglitazone Maleate + Metformin film coated tablets (Avandamet) 4 milligrams (mg) + 1000 mg (GlaxoSmithKline Brasil Ltda) in Period 1; followed by a 7-day washout period during which no medication was administered; followed by reference product: Avandamet 2 mg + 500 mg (GlaxoSmithKline Brasil Ltda) in Period 2
269897|NCT01332071|O2|Outcome|Reference Product|Reference product: Metformin Hydrochloride 500 mg in both periods
269898|NCT01332071|O1|Outcome|Test Product|Test product: Metformin Hydrochloride 1000 mg in both periods
269899|NCT01332071|O2|Outcome|Reference Product|Reference product: Metformin Hydrochloride 500 mg in both periods
269900|NCT01332071|O1|Outcome|Test Product|Test product: Metformin Hydrochloride 1000 mg in both periods
269901|NCT01332071|O2|Outcome|Reference Product|Reference product: Metformin Hydrochloride 500 mg in both periods
269902|NCT01332071|O1|Outcome|Test Product|Test product: Metformin Hydrochloride 1000 mg in both periods
269903|NCT01332071|O2|Outcome|Reference Product|Reference product: Rosiglitazone Maleate 2 mg in both periods
269904|NCT01332071|O1|Outcome|Test Product|Test product: Rosiglitazone Maleate 4 mg in both periods
269905|NCT01332071|O2|Outcome|Reference Product|Reference product: Rosiglitazone Maleate 2 mg in both periods
269906|NCT01332071|O1|Outcome|Test Product|Test product: Rosiglitazone Maleate 4 mg in both periods
269907|NCT01332071|O2|Outcome|Reference Product|Reference product: Rosiglitazone Maleate 2 mg in both periods
269908|NCT01332071|O1|Outcome|Test Product|Test product: Rosiglitazone Maleate 4 mg in both periods
269909|NCT01332071|E2|Reported Event|Reference Product in Period 1; Test Product in Period 2|Reference product: Avandamet 2 mg + 500 mg in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: Avandamet 4 mg + 1000 mg in Period 2
269910|NCT01332071|E1|Reported Event|Test Product in Period 1; Reference Product in Period 2|Test product: Rosiglitazone Maleate + Metformin film coated tablets (Avandamet) 4 milligrams (mg) + 1000 mg (GlaxoSmithKline Brasil Ltda) in Period 1; followed by a 7-day washout period during which no medication was administered; followed by reference product: Avandamet 2 mg + 500 mg (GlaxoSmithKline Brasil Ltda) in Period 2
269911|NCT01332019|B3|Baseline|Total|Total of all reporting groups
269912|NCT01332019|B2|Baseline|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269913|NCT01332019|B1|Baseline|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269914|NCT01332019|P2|Participant Flow|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269915|NCT01332019|P1|Participant Flow|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269916|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269917|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269918|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269919|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269920|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269921|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269922|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269923|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269924|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269925|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269926|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269927|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269928|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269929|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269930|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269931|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269932|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269933|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269934|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269935|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269936|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
270228|NCT01330394|B3|Baseline|Total|Total of all reporting groups
269942|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269943|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269944|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269945|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269946|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269947|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269948|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269949|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269950|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269951|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269952|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269953|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269954|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269955|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269956|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269957|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269958|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269959|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269960|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269961|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269962|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269963|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269964|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269965|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269966|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269967|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269968|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269969|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269970|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269971|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269972|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269973|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269974|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269975|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269976|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269977|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269978|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269979|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269980|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269981|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269982|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269983|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269984|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269985|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269986|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269987|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269988|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269989|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269990|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269991|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269992|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269993|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269994|NCT01332019|E2|Reported Event|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
269995|NCT01332019|E1|Reported Event|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
269996|NCT01331837|B3|Baseline|Total|Total of all reporting groups
269997|NCT01331837|B2|Baseline|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
269998|NCT01331837|B1|Baseline|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
269999|NCT01331837|P2|Participant Flow|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
270000|NCT01331837|P1|Participant Flow|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
270001|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
270002|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
270003|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
270004|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
270005|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
270006|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
270007|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
270008|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
270009|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
270010|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
270011|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
270012|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
270013|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
270014|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
270015|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
270016|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
270017|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
270018|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
270019|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
270020|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
270021|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
270022|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
270023|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
270024|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
270025|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
270026|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
270027|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
270028|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
270029|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
270030|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
270031|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
270032|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
270033|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
270034|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
270035|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
270036|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
270037|NCT01331837|E2|Reported Event|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
270038|NCT01331837|E1|Reported Event|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
270039|NCT01331824|B1|Baseline|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
270040|NCT01331824|P1|Participant Flow|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
270041|NCT01331824|O1|Outcome|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
270042|NCT01331824|O1|Outcome|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
270043|NCT01331824|O1|Outcome|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
270044|NCT01331824|O1|Outcome|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
270045|NCT01331824|E1|Reported Event|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
270046|NCT01331694|B7|Baseline|Total|Total of all reporting groups
270047|NCT01331694|B6|Baseline|Cost Population: TIO|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
270048|NCT01331694|B5|Baseline|Cost Population: IP|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
270049|NCT01331694|B4|Baseline|Cost Population: FSC|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
270050|NCT01331694|B3|Baseline|Risk Population: TIO|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
270051|NCT01331694|B2|Baseline|Risk Population: IP|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
270052|NCT01331694|B1|Baseline|Risk Population: FSC|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
270053|NCT01331694|P6|Participant Flow|Cost Population: TIO|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
270054|NCT01331694|P5|Participant Flow|Cost Population: IP|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
270055|NCT01331694|P4|Participant Flow|Cost Population: FSC|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
270056|NCT01331694|P3|Participant Flow|Risk Population: TIO|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
270057|NCT01331694|P2|Participant Flow|Risk Population: IP|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
270058|NCT01331694|P1|Participant Flow|Risk Population: FSC|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 micrograms (mcg)/50 mcg
270059|NCT01331694|O3|Outcome|Cost Population: TIO|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
270060|NCT01331694|O2|Outcome|Cost Population: IP|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
270061|NCT01331694|O1|Outcome|Cost Population: FSC|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
270062|NCT01331694|O3|Outcome|Risk Population TIO|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
270063|NCT01331694|O2|Outcome|Risk Population: IP|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
270064|NCT01331694|O1|Outcome|Risk Population: FSC|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
270065|NCT01331694|E6|Reported Event|Cost Population: TIO|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
270229|NCT01330394|B2|Baseline|Active tDCS|active transcranial Direct Current Stimulation
270066|NCT01331694|E5|Reported Event|Cost Population: IP|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
270067|NCT01331694|E4|Reported Event|Cost Population: FSC|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
270068|NCT01331694|E3|Reported Event|Risk Population: TIO|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
270069|NCT01331694|E2|Reported Event|Risk Population: IP|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
270070|NCT01331694|E1|Reported Event|Risk Population: FSC|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
270071|NCT01331681|B4|Baseline|Total|Total of all reporting groups
270072|NCT01331681|B3|Baseline|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
270073|NCT01331681|B2|Baseline|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
270074|NCT01331681|B1|Baseline|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
270075|NCT01331681|P3|Participant Flow|Macular Laser Photocoagulation (Control)|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
270076|NCT01331681|P2|Participant Flow|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
270077|NCT01331681|P1|Participant Flow|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
270078|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
270079|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
270080|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
270081|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
270082|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
270083|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
270084|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
270085|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
270086|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
270087|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
270088|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
270089|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
270090|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
270091|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
270092|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
270093|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
270094|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
270095|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
270096|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
270097|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
271465|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
270098|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
270099|NCT01331681|E3|Reported Event|Macular Laser Photocoagulation (Control)|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks. During year 3 laser patients could receive IAI as needed (PRN) .
270100|NCT01331681|E2|Reported Event|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
270101|NCT01331681|E1|Reported Event|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
270102|NCT01331304|B3|Baseline|Total|Total of all reporting groups
270103|NCT01331304|B2|Baseline|QTP + APT|"Study participants will take quetiapine in addition to any other medications recommended by the study physician.~Quetiapine: 100-800mg a day over 6 months"
270104|NCT01331304|B1|Baseline|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.~Lithium: 600-1200mg per day over 6 months"
270105|NCT01331304|P2|Participant Flow|QTP + APT|"Study participants will take quetiapine in addition to any other medications recommended by the study physician.~Quetiapine: 100-800mg a day over 6 months"
270106|NCT01331304|P1|Participant Flow|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.~Lithium: 600-1200mg per day over 6 months"
270107|NCT01331304|O2|Outcome|QTP + APT|"Study participants will take quetiapine in addition to any other medications recommended by the study physician.~Quetiapine: 100-800mg a day over 6 months"
270108|NCT01331304|O1|Outcome|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.~Lithium: 600-900mg per day over 6 months"
270109|NCT01331304|O2|Outcome|QTP + APT|"Study participants will take quetiapine in addition to any other medications recommended by the study physician.~Quetiapine: 100-800mg a day over 6 months"
270110|NCT01331304|O1|Outcome|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.~Lithium: 600-900mg per day over 6 months"
270111|NCT01331304|O2|Outcome|QTP + APT|"Study participants will take quetiapine in addition to any other medications recommended by the study physician.~Quetiapine: 100-800mg a day over 6 months"
270112|NCT01331304|O1|Outcome|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.~Lithium: 600-1200mg per day over 6 months"
270113|NCT01331304|O2|Outcome|QTP + APT|"Study participants will take quetiapine in addition to any other medications recommended by the study physician.~Quetiapine: 100-800mg a day over 6 months"
270114|NCT01331304|O1|Outcome|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.~Lithium: 600-1200mg per day over 6 months"
270115|NCT01331304|E2|Reported Event|QTP + APT|"Study participants will take quetiapine in addition to any other medications recommended by the study physician.~Quetiapine: 100-800mg a day over 6 months"
270116|NCT01331304|E1|Reported Event|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.~Lithium: 600-1200mg per day over 6 months"
270117|NCT01331291|B3|Baseline|Total|Total of all reporting groups
270118|NCT01331291|B2|Baseline|Arm B|"Patients that are not surgical candidates~bosutinib: Taken orally"
270119|NCT01331291|B1|Baseline|Arm A|"Patients who are surgical candidates~bosutinib: Taken orally"
270120|NCT01331291|P2|Participant Flow|Arm B|"Patients that are not surgical candidates~bosutinib: Taken orally"
270121|NCT01331291|P1|Participant Flow|Arm A|"Patients who are surgical candidates~bosutinib: Taken orally"
270122|NCT01331291|O2|Outcome|Arm B|"Patients that are not surgical candidates~bosutinib: Taken orally"
270123|NCT01331291|O1|Outcome|Arm A|"Patients who are surgical candidates~bosutinib: Taken orally"
270124|NCT01331291|O2|Outcome|Arm B|"Patients that are not surgical candidates~bosutinib: Taken orally"
270125|NCT01331291|O1|Outcome|Arm A|"Patients who are surgical candidates~bosutinib: Taken orally"
270126|NCT01331291|O2|Outcome|Arm B|"Patients that are not surgical candidates~bosutinib: Taken orally"
270127|NCT01331291|O1|Outcome|Arm A|"Patients who are surgical candidates~bosutinib: Taken orally"
270128|NCT01331291|O2|Outcome|Arm B|"Patients that are not surgical candidates~bosutinib: Taken orally"
270129|NCT01331291|O1|Outcome|Arm A|"Patients who are surgical candidates~bosutinib: Taken orally"
270130|NCT01331291|E1|Reported Event|Combined Arms|Adverse Events were measured across all participants, regardless of arm.
270131|NCT01331213|B3|Baseline|Total|Total of all reporting groups
270132|NCT01331213|B2|Baseline|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
270133|NCT01331213|B1|Baseline|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
270134|NCT01331213|P2|Participant Flow|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
270135|NCT01331213|P1|Participant Flow|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
270136|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
270137|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
270138|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
270139|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
270140|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
270141|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
270142|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
270143|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
271466|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
270144|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
270145|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
270146|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
270147|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
270148|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
270149|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
270150|NCT01331213|E2|Reported Event|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
270151|NCT01331213|E1|Reported Event|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
270152|NCT01331161|B3|Baseline|Total|Total of all reporting groups
270153|NCT01331161|B2|Baseline|Age 25-40 Years|Participants between the ages of 25-40 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.
270154|NCT01331161|B1|Baseline|Age 60-79 Years|Participants between the ages of 60-79 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.
270155|NCT01331161|P2|Participant Flow|Younger Group|"Participants between the ages of 25-40~ZOSTAVAX: shingles vaccine, one dose"
270156|NCT01331161|P1|Participant Flow|Older Group|"Participants between the ages of 60-79~ZOSTAVAX: shingles vaccine, one dose"
270157|NCT01331161|O2|Outcome|Age 25-40 Years|Participants between the ages of 25-40 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.
270158|NCT01331161|O1|Outcome|Age 60-79 Years|Participants between the ages of 60-79 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.
270159|NCT01331161|O2|Outcome|Participants 25-40 Years of Age|participants with one dose of vaccine
270160|NCT01331161|O1|Outcome|Participants 60-79 Years|participants who received one dose of vaccine
270161|NCT01331161|E2|Reported Event|Younger Group|"Participants between the ages of 25-40~ZOSTAVAX: shingles vaccine, one dose"
270162|NCT01331161|E1|Reported Event|Older Group|"Participants between the ages of 60-79~ZOSTAVAX: shingles vaccine, one dose"
270163|NCT01331109|B1|Baseline|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
270164|NCT01331109|P1|Participant Flow|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
270165|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
270166|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
270167|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
270168|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
270169|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
270170|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
270171|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
270172|NCT01331109|E1|Reported Event|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
270173|NCT01331005|B3|Baseline|Total|Total of all reporting groups
270174|NCT01331005|B2|Baseline|Nepafenac 0.1% Drops|"Nepafenac drops will be given three times per day for one year~nepafenac 0.1% drops: One drop three times per day for one year"
270175|NCT01331005|B1|Baseline|Placebo|"Placebo will be given three times per day for one year~Nepafenac Vehicle: Placebo"
270176|NCT01331005|P2|Participant Flow|Nepafenac 0.1% Drops|"Nepafenac drops will be given three times per day for one year~nepafenac 0.1% drops: One drop three times per day for one year"
270177|NCT01331005|P1|Participant Flow|Placebo|"Placebo will be given three times per day for one year~Nepafenac Vehicle: Placebo"
270178|NCT01331005|O2|Outcome|Nepafenac 0.1% Drops|"Nepafenac drops will be given three times per day for one year~nepafenac 0.1% drops: One drop three times per day for one year"
270179|NCT01331005|O1|Outcome|Placebo|"Placebo will be given three times per day for one year~Nepafenac Vehicle: Placebo"
270180|NCT01331005|E2|Reported Event|Nepafenac 0.1% Drops|"Nepafenac drops will be given three times per day for one year~nepafenac 0.1% drops: One drop three times per day for one year"
270181|NCT01331005|E1|Reported Event|Placebo|"Placebo will be given three times per day for one year~Nepafenac Vehicle: Placebo"
270182|NCT01330914|B1|Baseline|Gastric Bypass Surgery Patients|Obese men and women undergoing gastric bypass surgery
270183|NCT01330914|P1|Participant Flow|Gastric Bypass Surgery Patients|Obese men and women undergoing gastric bypass surgery
270184|NCT01330914|O1|Outcome|Gastric Bypass Surgery Patients|Obese men and women undergoing gastric bypass surgery
270185|NCT01330914|E1|Reported Event|Gastric Bypass Surgery Patients|Obese men and women undergoing gastric bypass surgery
270186|NCT01330628|B3|Baseline|Total|Total of all reporting groups
270187|NCT01330628|B2|Baseline|Balloon Angioplasty|Balloon angioplasty: standard balloon catheters for PTA
270188|NCT01330628|B1|Baseline|Laser Atherectomy and PTA|"laser, then balloon angioplasty~Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty"
270189|NCT01330628|P2|Participant Flow|Balloon Angioplasty|Balloon angioplasty: standard balloon catheters for PTA
270190|NCT01330628|P1|Participant Flow|Laser Atherectomy and PTA|"laser, then balloon angioplasty~Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty"
270191|NCT01330628|O2|Outcome|Balloon Angioplasty|Balloon angioplasty: standard balloon catheters for PTA
270192|NCT01330628|O1|Outcome|Laser Atherectomy and PTA|"laser, then balloon angioplasty~Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty"
270193|NCT01330628|O2|Outcome|Balloon Angioplasty|Balloon angioplasty: standard balloon catheters for PTA
270194|NCT01330628|O1|Outcome|Laser Atherectomy and PTA|"laser, then balloon angioplasty~Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty"
270195|NCT01330628|E2|Reported Event|Balloon Angioplasty|Balloon angioplasty: standard balloon catheters for PTA
270196|NCT01330628|E1|Reported Event|Laser Atherectomy and PTA|"laser, then balloon angioplasty~Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty"
270197|NCT01330433|B3|Baseline|Total|Total of all reporting groups
270198|NCT01330433|B2|Baseline|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
270199|NCT01330433|B1|Baseline|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
270200|NCT01330433|P2|Participant Flow|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
270201|NCT01330433|P1|Participant Flow|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
270202|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
270203|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
270204|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
270205|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
270206|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
270207|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
270208|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
270209|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
270210|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
270211|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
270212|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
270213|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
270214|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
270215|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
270216|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
270217|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
270218|NCT01330433|E2|Reported Event|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
270219|NCT01330433|E1|Reported Event|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
270220|NCT01330420|B1|Baseline|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session, 1.5 hour, mind body intervention.~The 3RP-D was designed to promote resiliency by reducing the harmful effects of stress through the elicitation of the relaxation response, and through skill training to enhance positive attitudes and beliefs, nutrition, exercise, recuperative sleep, social support, and coping. Specific interventions include: cognitive behavioral therapy (CBT), enhancing social support (SS), cultivating positive attitudes and beliefs (CPE), and promoting Healthy Lifestyle Habits(HL). The 3RP-D program has been manualized for use by group facilitators and health center patients."
270221|NCT01330420|P1|Participant Flow|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.)~The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL)."
270222|NCT01330420|O1|Outcome|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.)~The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL)."
270223|NCT01330420|O1|Outcome|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.)~The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL)."
270224|NCT01330420|O1|Outcome|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.)~The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL)."
270225|NCT01330420|O1|Outcome|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.)~The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL)."
270226|NCT01330420|O1|Outcome|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.)~The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL)."
270227|NCT01330420|E1|Reported Event|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session, 1.5 hour, mind body intervention.~The 3RP-D was designed to promote resiliency by reducing the harmful effects of stress through the elicitation of the relaxation response, and through skill training to enhance positive attitudes and beliefs, nutrition, exercise, recuperative sleep, social support, and coping. Specific interventions include: cognitive behavioral therapy (CBT), enhancing social support (SS), cultivating positive attitudes and beliefs (CPE), and promoting Healthy Lifestyle Habits(HL). The 3RP-D program has been manualized for use by group facilitators and health center patients."
270230|NCT01330394|B1|Baseline|Sham-tDCS Control|simulate control for transcranial Direct Current Stimulation
270231|NCT01330394|P2|Participant Flow|Active tDCS|active transcranial Direct Current Stimulation (tDCS, 5 x 7 cm2, 2 mA, double 13 min stimulation with 20 min interval between them) was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex once a day for 5 consecutive days
270232|NCT01330394|P1|Participant Flow|Sham-tDCS Control|simulate control for bilateral transcranial Direct Current Stimulation on the left and right dorsolateral prefrontal cortex
270233|NCT01330394|O2|Outcome|Active tDCS|active transcranial Direct Current Stimulation
270234|NCT01330394|O1|Outcome|Sham-tDCS Control|simulate control for transcranial Direct Current Stimulation
270235|NCT01330394|E2|Reported Event|Active tDCS|active transcranial Direct Current Stimulation
270236|NCT01330394|E1|Reported Event|Sham-tDCS Control|simulate control for transcranial Direct Current Stimulation
270237|NCT01330381|B3|Baseline|Total|Total of all reporting groups
270238|NCT01330381|B2|Baseline|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
270239|NCT01330381|B1|Baseline|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
270240|NCT01330381|P3|Participant Flow|PEG 4000 (Polyethylene Glycol)|Subjects received PEG 4000 oral solution at a dose of 4 gram to 20 gram once daily.
270241|NCT01330381|P2|Participant Flow|Placebo|"Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution.~Subjects with weight >50 kg received placebo matching prucalopride oral tablet."
270242|NCT01330381|P1|Participant Flow|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
270243|NCT01330381|O2|Outcome|PEG 4000|Subjects received PEG 4000 oral solution at a dose of 4 gram to 20 gram once daily.
270244|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
270245|NCT01330381|O2|Outcome|PEG 4000|Subjects received PEG 4000 oral solution at a dose of 4 gram to 20 gram once daily.
270246|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
270247|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
270248|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
270249|NCT01330381|O2|Outcome|PEG 4000|Subjects received PEG 4000 oral solution at a dose of 4 gram to 20 gram once daily.
270250|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
270251|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
270252|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
270253|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
270254|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
270255|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
270256|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
270257|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
270258|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
270259|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
270260|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
270261|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
270262|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
270263|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
270264|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
270265|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
270412|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
270266|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
270267|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
270268|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
270269|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
270270|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
270271|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
270272|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
270273|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
270274|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
270275|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
270276|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
270277|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
270278|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
270279|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
270280|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
270281|NCT01330381|E4|Reported Event|PEG 4000 (Open-label Period)|Subjects received PEG 4000 oral solution at a dose of 4 gram to 20 gram once daily.
270282|NCT01330381|E3|Reported Event|Prucalopride (Open-label Period)|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
270283|NCT01330381|E2|Reported Event|Placebo (Double-blind Period)|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
270284|NCT01330381|E1|Reported Event|Prucalopride (Double-blind Period)|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
270285|NCT01330355|B3|Baseline|Total|Total of all reporting groups
270286|NCT01330355|B2|Baseline|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution~Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
270287|NCT01330355|B1|Baseline|Besivance|"Besifloxacin 0.6% ophthalmic suspension~Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
270288|NCT01330355|P2|Participant Flow|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution~Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
270289|NCT01330355|P1|Participant Flow|Besivance|"Besifloxacin 0.6% ophthalmic suspension~Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
270290|NCT01330355|O2|Outcome|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution~Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
270291|NCT01330355|O1|Outcome|Besivance|"Besifloxacin 0.6% ophthalmic suspension~Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
270292|NCT01330355|O2|Outcome|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution~Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
270293|NCT01330355|O1|Outcome|Besivance|"Besifloxacin 0.6% ophthalmic suspension~Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
270294|NCT01330355|O2|Outcome|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution~Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
270295|NCT01330355|O1|Outcome|Besivance|"Besifloxacin 0.6% ophthalmic suspension~Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
270296|NCT01330355|O2|Outcome|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution~Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
270297|NCT01330355|O1|Outcome|Besivance|"Besifloxacin 0.6% ophthalmic suspension~Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
270298|NCT01330355|E2|Reported Event|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution~Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
270413|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
270299|NCT01330355|E1|Reported Event|Besivance|"Besifloxacin 0.6% ophthalmic suspension~Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
270300|NCT01330316|B3|Baseline|Total|Total of all reporting groups
270301|NCT01330316|B2|Baseline|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
270302|NCT01330316|B1|Baseline|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
270303|NCT01330316|P2|Participant Flow|Non-relapse|"Faldaprevir (FDV) 240mg once daily combined with Pegylated interferon α-2a (PegIFN)/ Ribavirin (RBV) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV for non-relapser patients.~Non-relapser are non-responder (null and partial) and breakthrough patients. Null responders are patients who did not achieve > 2 log10 decrease in HCV RNA from baseline during the treatment period.~Partial non-responders are patients who achieved > 2 log10 decrease in HCV RNA from baseline but who never achieved an undetectable level of HCV RNA.~Breakthrough are patients who achieved an undetectable HCV RNA during the treatment period but had detectable HCV RNA at the end of treatment."
270304|NCT01330316|P1|Participant Flow|Relapse|"Faldaprevir (FDV) 240 mg once daily combined with Pegylated interferon α-2a (PegIFN)/ Ribavirin (RBV) for 24 weeks was administered for relapser patients.~At week 24, patients who did not achieve early treatment success (ETS) continue with an additional 24 weeks of PegIFN/RBV.~ETS is defined as Hepatitis C virus(HCV) Ribonucleic Acid (RNA) <25 Internalional Units (IU)/millilitre (ml) (detected or undetected) at week 4 and <25 IU/ml (undetected) at week 8.~Patients who had undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels at the end of treatment in one of the previous studies (see recruitment details) but had detectable levels in subsequent assessments are called relapser."
270305|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
270306|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
270307|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
270308|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
270309|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
270310|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
270311|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
270312|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
270313|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
270314|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
270315|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
270316|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
270317|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
270318|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
270319|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
270320|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
270321|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
270322|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
270323|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
270324|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
270325|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
270326|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
270327|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
270328|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
270329|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
270330|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
270331|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
270332|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
270333|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
270334|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
270335|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
270336|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
270337|NCT01330316|E2|Reported Event|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
270338|NCT01330316|E1|Reported Event|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
270339|NCT01330303|B1|Baseline|Participants Receiving Both Test Product and Reference Product|Participants receiving either test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in Period 1; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 2 or reference product in Period 1 and test product in Period 2
270340|NCT01330303|P2|Participant Flow|Reference Product in Period 1; Test Product in Period 2|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in Period 2
270341|NCT01330303|P1|Participant Flow|Test Product in Period 1; Reference Product in Period 2|Test product: tamsulosin hydrochloride 0.4 milligrams (mg) prolonged release hard gelatin capsule in Period 1; followed by a 7-day washout period during which no medication was administered; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 2
270342|NCT01330303|O2|Outcome|Reference Product|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in both period
270343|NCT01330303|O1|Outcome|Test Product|Test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in both periods
270344|NCT01330303|O2|Outcome|Reference Product|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in both period
270345|NCT01330303|O1|Outcome|Test Product|Test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in both periods
270346|NCT01330303|O2|Outcome|Reference Product|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in both periods
270347|NCT01330303|O1|Outcome|Test Product|Test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in both periods
270348|NCT01330303|E2|Reported Event|Reference Product in Period 1; Test Product in Period 2|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in Period 2
270349|NCT01330303|E1|Reported Event|Test Product in Period 1; Reference Product in Period 2|Test product: tamsulosin hydrochloride 0.4 milligrams (mg) prolonged release hard gelatin capsule in Period 1; followed by a 7-day washout period during which no medication was administered; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 2
270350|NCT01330290|B1|Baseline|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
270351|NCT01330290|P1|Participant Flow|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
270352|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
270353|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
270354|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
270414|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
270415|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
270416|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
292009|NCT01265667|O2|Outcome|Placebo|Placebo: orally q12h
270355|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
270356|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
270357|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
270358|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
270359|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
270360|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
270361|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
270362|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
270363|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
270364|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
270365|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
270366|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
270367|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
270417|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
271467|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
270368|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
270369|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
270370|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
270371|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
270372|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
270373|NCT01330290|E1|Reported Event|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
270374|NCT01330108|B1|Baseline|Ambrisentan|"patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.~ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage."
270375|NCT01330108|P1|Participant Flow|Ambrisentan|"patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.~ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage."
270376|NCT01330108|O1|Outcome|Ambrisentan|"patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.~ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage."
270377|NCT01330108|O1|Outcome|Ambrisentan|"patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.~ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage."
270378|NCT01330108|E1|Reported Event|Ambrisentan|"patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.~ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage."
270379|NCT01330043|B3|Baseline|Total|Total of all reporting groups
270380|NCT01330043|B2|Baseline|Extended Treatment|Participants receive 52 weeks of cognitive behavioral therapy (maintenance plus extended treatment). Cognitive behavior therapy (CBT): During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26. All will receive CBT through week 52.
270381|NCT01330043|B1|Baseline|Maintenance Treatment|Participants receive 26 weeks of cognitive behavioral therapy (maintenance treatment) followed by a monthly phone call asking about their smoking status and will not receive any additional behavioral treatment after 26 weeks. Cognitive behavior therapy (CBT): During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26. All will receive CBT through week 26.
270382|NCT01330043|P2|Participant Flow|Extended Treatment|Participants will receive twelve months (52 weeks) of cognitive behavioral therapy.
270383|NCT01330043|P1|Participant Flow|Maintenance Therapy|Participants will receive six months (26 weeks) of cognitive behavioral therapy (maintenance treatment) and a monthly phone call after 26 weeks asking about their smoking status and will not receive any treatment.
270384|NCT01330043|O2|Outcome|Extended Treatment|Participants receive 52 weeks of cognitive behavioral therapy (extended treatment). During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26. All will receive CBT through week 52.
270418|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
270419|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
270420|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
270385|NCT01330043|O1|Outcome|Maintenance Treatment|Participants receive 26 weeks of cognitive behavioral therapy (maintenance treatment) followed by a monthly phone call asking about their smoking status and will not receive any additional behavioral treatment after 26 weeks. During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26. All will receive CBT through week 52.
270386|NCT01330043|O2|Outcome|Extended Treatment|Participants receive 52 weeks of cognitive behavioral therapy (extended treatment). During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26. All will receive CBT through week 52.
270387|NCT01330043|O1|Outcome|Maintenance Treatment|Participants receive 26 weeks of cognitive behavioral therapy (maintenance treatment) followed by a monthly phone call asking about their smoking status and will not receive any additional behavioral treatment after 26 weeks. During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26. All will receive CBT through week 52.
270388|NCT01330043|E2|Reported Event|Extended Treatment|"Participants receive 26 weeks of cognitive behavioral therapy (maintenance treatment) followed by another 26 weeks of cognitive behavioral therapy (extended treatment). Cognitive behavior therapy (CBT): During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26.~Maintenance treatment (cognitive behavioral therapy)(CBT): During open label treatment, all receive CBT and bupropion and NRT patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of cravin"
270389|NCT01330043|E1|Reported Event|Maintenance Treatment|"Participants receive 26 weeks of cognitive behavioral therapy (maintenance treatment) followed by a monthly phone call asking about their smoking status and will not receive any additional behavioral treatment after 26 weeks. Cognitive behavior therapy (CBT): During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26.~Maintenance treatment (cognitive behavioral therapy)(CBT): During open label treatment, all receive CBT and bupropion and NRT patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 1"
270390|NCT01330030|B3|Baseline|Total|Total of all reporting groups
270391|NCT01330030|B2|Baseline|Matching Placebo|"matching placebo worn 24 hours for 8 weeks~matching placebo: placebo/24hrs for 8 weeks"
270392|NCT01330030|B1|Baseline|Drug Selegiline|"6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks~Selegiline: 6mg/24 hrs for 8 weeks"
270393|NCT01330030|P2|Participant Flow|Matching Placebo|matching placebo worn 24 hours for 8 weeks
270394|NCT01330030|P1|Participant Flow|Drug Selegiline|6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks
270395|NCT01330030|O2|Outcome|Matching Placebo|"matching placebo worn 24 hours for 8 weeks~matching placebo: placebo/24hrs for 8 weeks"
270396|NCT01330030|O1|Outcome|Drug Selegiline|"6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks~Selegiline: 6mg/24 hrs for 8 weeks"
270397|NCT01330030|E2|Reported Event|Matching Placebo|"matching placebo worn 24 hours for 8 weeks~matching placebo: placebo/24hrs for 8 weeks"
270398|NCT01330030|E1|Reported Event|Drug Selegiline|"6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks~Selegiline: 6mg/24 hrs for 8 weeks"
270399|NCT01330017|B6|Baseline|Total|Total of all reporting groups
270400|NCT01330017|B5|Baseline|Placebo|Matching placebo was administered orally every 4 hours in combination with background loratadine treatment.
270401|NCT01330017|B4|Baseline|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
270402|NCT01330017|B3|Baseline|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
270403|NCT01330017|B2|Baseline|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
270404|NCT01330017|B1|Baseline|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
270405|NCT01330017|P5|Participant Flow|Placebo|Matching placebo was administered orally every 4 hours in combination with background loratadine treatment.
270406|NCT01330017|P4|Participant Flow|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
270407|NCT01330017|P3|Participant Flow|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
270408|NCT01330017|P2|Participant Flow|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
270409|NCT01330017|P1|Participant Flow|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
270410|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
270411|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
271468|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
270421|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
270422|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
270423|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
270424|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
270425|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
270426|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
270427|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
270428|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
270429|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
270430|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
270431|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
270432|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
270433|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
270434|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
270435|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
270436|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
270437|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
270438|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
270439|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
270440|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
270441|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
270442|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
270443|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
270444|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
270445|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
270446|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
270447|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
270448|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
270449|NCT01330017|E5|Reported Event|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
270450|NCT01330017|E4|Reported Event|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
270451|NCT01330017|E3|Reported Event|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
270452|NCT01330017|E2|Reported Event|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
270453|NCT01330017|E1|Reported Event|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
270454|NCT01329978|B4|Baseline|Total|Total of all reporting groups
270455|NCT01329978|B3|Baseline|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
270456|NCT01329978|B2|Baseline|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
270457|NCT01329978|B1|Baseline|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
270458|NCT01329978|P5|Participant Flow|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
270459|NCT01329978|P4|Participant Flow|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
270460|NCT01329978|P3|Participant Flow|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
270461|NCT01329978|P2|Participant Flow|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
270462|NCT01329978|P1|Participant Flow|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive sofosbuvir (SOF) 400 mg+pegylated interferon alfa-2a (PEG) 180 µg+ribavirin (RBV) 1000-1200 mg for 12 weeks.
270463|NCT01329978|O5|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
270464|NCT01329978|O4|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
271469|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
270465|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
270466|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
270467|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
270468|NCT01329978|O5|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
270469|NCT01329978|O4|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
270470|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
270471|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
270472|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
270473|NCT01329978|O5|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
270474|NCT01329978|O4|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
270475|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
270476|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
270477|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
270478|NCT01329978|O4|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
270479|NCT01329978|O3|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
270480|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
270481|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
270482|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
270483|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
270484|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
270485|NCT01329978|O4|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
270486|NCT01329978|O3|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
270487|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
270488|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
270489|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
270490|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
270491|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
270492|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
270493|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
270494|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
270495|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
270496|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
270497|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
270498|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
270499|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
270500|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
270501|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
292010|NCT01265667|O1|Outcome|CF101 2 mg|CF101: orally q12h
270502|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
270503|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
270504|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
270505|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
270506|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
270507|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
270508|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
270509|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
270510|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
270511|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
270512|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
270513|NCT01329978|O5|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
270514|NCT01329978|O4|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
270515|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
270516|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
270517|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
270518|NCT01329978|O5|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
270519|NCT01329978|O4|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
270520|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
270521|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
270522|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
270523|NCT01329978|O5|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
270524|NCT01329978|O4|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
270525|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
270526|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
270527|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
270528|NCT01329978|E3|Reported Event|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
270529|NCT01329978|E2|Reported Event|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
270530|NCT01329978|E1|Reported Event|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
270531|NCT01329939|B5|Baseline|Total|Total of all reporting groups
270532|NCT01329939|B4|Baseline|Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
270533|NCT01329939|B3|Baseline|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
270534|NCT01329939|B2|Baseline|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
270535|NCT01329939|B1|Baseline|Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
270536|NCT01329939|P4|Participant Flow|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
270537|NCT01329939|P3|Participant Flow|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
270538|NCT01329939|P2|Participant Flow|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
270539|NCT01329939|P1|Participant Flow|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
270540|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
270541|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
270542|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
270543|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
270544|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
270545|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
270546|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
270547|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
270548|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
270549|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
270550|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
270551|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
270552|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
270553|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
270554|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
270555|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
270556|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
270557|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
270558|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
270559|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
270560|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
270561|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
270562|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
270563|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
270564|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
270565|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
270566|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
270567|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
270568|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
270569|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
270570|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
270571|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
270572|NCT01329939|E4|Reported Event|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
270573|NCT01329939|E3|Reported Event|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
270574|NCT01329939|E2|Reported Event|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
270575|NCT01329939|E1|Reported Event|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
270576|NCT01329848|B1|Baseline|Discomfort Symptoms|level of discomfort symptoms while performing near work
270577|NCT01329848|P1|Participant Flow|Discomfort Symptoms|levels of discomfort while performing near work
270578|NCT01329848|O1|Outcome|Discomfort Symptoms|level of discomfort symptoms while performing near work
270579|NCT01329848|O1|Outcome|Discomfort Symptoms|level of discomfort symptoms while performing near work
270580|NCT01329848|E1|Reported Event|Changes in Visual Discomfort From Baseline|Visual discomfort while making auto-refraction recordings.
270581|NCT01329679|B1|Baseline|All Study Participants|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days Placebo: Water, lime juice and cherry flavoring
270582|NCT01329679|P2|Participant Flow|Placebo, Then Energy Drink|
270583|NCT01329679|P1|Participant Flow|Energy Drink, Then Placebo|
270584|NCT01329679|O2|Outcome|Placebo|Placebo: Water, lime juice and cherry flavoring
270585|NCT01329679|O1|Outcome|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
270586|NCT01329679|O2|Outcome|Placebo|Placebo: Water, lime juice and cherry flavoring
270587|NCT01329679|O1|Outcome|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
270588|NCT01329679|O2|Outcome|Placebo|Placebo: Water, lime juice and cherry flavoring
270589|NCT01329679|O1|Outcome|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
270590|NCT01329679|O2|Outcome|Placebo|Placebo: Water, lime juice and cherry flavoring
270591|NCT01329679|O1|Outcome|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
270592|NCT01329679|O2|Outcome|Placebo|
270593|NCT01329679|O1|Outcome|5 Hour Energy|
270594|NCT01329679|O2|Outcome|Placebo|Placebo: Water, lime juice and cherry flavoring
270595|NCT01329679|O1|Outcome|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
270596|NCT01329679|O2|Outcome|Placebo|Placebo: Water, lime juice and cherry flavoring
270597|NCT01329679|O1|Outcome|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
270598|NCT01329679|E2|Reported Event|Placebo|Placebo: Water, lime juice and cherry flavoring
270599|NCT01329679|E1|Reported Event|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
270600|NCT01329562|B3|Baseline|Total|Total of all reporting groups
270601|NCT01329562|B2|Baseline|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270602|NCT01329562|B1|Baseline|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
270603|NCT01329562|P2|Participant Flow|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270604|NCT01329562|P1|Participant Flow|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
270605|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270606|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270607|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
270608|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270609|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270610|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
270611|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270612|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270613|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
270718|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270614|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270615|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270616|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
270617|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270618|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
270619|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270620|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
270621|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270622|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
270623|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270624|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
270625|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270626|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270627|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
270658|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
270628|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270629|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270630|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
270631|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270632|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270633|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
270634|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270635|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270636|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
270637|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270638|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270639|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
270716|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270640|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270641|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
270642|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270643|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
270644|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270645|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
270646|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270647|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
270648|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270649|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
270650|NCT01329562|E2|Reported Event|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
270651|NCT01329562|E1|Reported Event|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
270652|NCT01329549|B1|Baseline|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
270653|NCT01329549|P1|Participant Flow|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
270654|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
270655|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
270656|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
270657|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
270717|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270659|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
270660|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
270661|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
270662|NCT01329549|E1|Reported Event|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
270663|NCT01329419|B1|Baseline|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
270664|NCT01329419|P1|Participant Flow|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
270665|NCT01329419|O1|Outcome|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 mg of adefovir dipivoxil administered once daily
270666|NCT01329419|O1|Outcome|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 mg of adefovir dipivoxil administered once daily
270667|NCT01329419|O1|Outcome|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
270668|NCT01329419|E1|Reported Event|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
270669|NCT01329263|B3|Baseline|Total|Total of all reporting groups
270670|NCT01329263|B2|Baseline|Control|Participants smoked their own menthol brand cigarette throughout the study.
270671|NCT01329263|B1|Baseline|Experimental|Group switched from menthol cigarette to non-menthol cigarette
270672|NCT01329263|P2|Participant Flow|Experimental|Menthol to non-menthol : Switch from smoking menthol to non-menthol cigarettes.
270673|NCT01329263|P1|Participant Flow|Control|Control group: continued to smoke same, own brand cigarette.
270674|NCT01329263|O2|Outcome|Experimental|Menthol to non-menthol : Switch from smoking menthol to non-menthol cigarettes.
270675|NCT01329263|O1|Outcome|Control|Control group: continued to smoke same, own brand cigarette.
270676|NCT01329263|O2|Outcome|Experimental|Menthol to non-menthol : Switch from smoking menthol to non-menthol cigarettes.
270677|NCT01329263|O1|Outcome|Control|Control group: continued to smoke same, own brand cigarette.
270678|NCT01329263|O2|Outcome|Control|Control group smoked their own brand cigarette for entire duration of study.
270679|NCT01329263|O1|Outcome|Experimental|Experimental group switched from menthol cigarette to non-menthol cigarette
270680|NCT01329263|O2|Outcome|Control|Control group smoked their own brand cigarette for entire duration of study.
270681|NCT01329263|O1|Outcome|Experimental|Experimental group switched from menthol cigarette to non-menthol cigarette
270682|NCT01329263|E2|Reported Event|Experimental|Menthol to non-menthol : Switch from smoking menthol to non-menthol cigarettes.
270683|NCT01329263|E1|Reported Event|Control|Control group: continued to smoke same, own brand cigarette.
270684|NCT01329198|B3|Baseline|Total|Total of all reporting groups
270685|NCT01329198|B2|Baseline|Active DBS|"Active stimulation through the Neuropace RNS system at settings to maximally reduce tic frequency & severity, while limiting potential stimulation-induced side-effects~NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
270686|NCT01329198|B1|Baseline|Sham DBS|"Sham stimulation in which no electrical charge is delivered through the Neuropace RNS system.~NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
270687|NCT01329198|P2|Participant Flow|Active DBS|"Active stimulation through the Neuropace RNS system at settings to maximally reduce tic frequency & severity, while limiting potential stimulation-induced side-effects~NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
270688|NCT01329198|P1|Participant Flow|Sham DBS|"Sham stimulation in which no electrical charge is delivered through the Neuropace RNS system.~NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
270689|NCT01329198|O5|Outcome|Subject 5|
270690|NCT01329198|O4|Outcome|Subject 4|
270691|NCT01329198|O3|Outcome|Subject 3|
270692|NCT01329198|O2|Outcome|Subject 2|
270693|NCT01329198|O1|Outcome|Subject 1|
270903|NCT01328574|E1|Reported Event|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously"
270694|NCT01329198|O2|Outcome|Active DBS|"Active stimulation through the Neuropace RNS system at settings to maximally reduce tic frequency & severity, while limiting potential stimulation-induced side-effects~NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
270695|NCT01329198|O1|Outcome|Sham DBS|"Sham stimulation in which no electrical charge is delivered through the Neuropace RNS system.~NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
270696|NCT01329198|E2|Reported Event|Active DBS|"Active stimulation through the Neuropace RNS system at settings to maximally reduce tic frequency & severity, while limiting potential stimulation-induced side-effects~NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
270697|NCT01329198|E1|Reported Event|Sham DBS|"Sham stimulation in which no electrical charge is delivered through the Neuropace RNS system.~NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
270698|NCT01329185|B3|Baseline|Total|Total of all reporting groups
270699|NCT01329185|B2|Baseline|Valganciclovir|"Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date~Valganciclovir: Valganciclovir 450mg twice a day for 14 days prior to transplant date"
270700|NCT01329185|B1|Baseline|Placebo|"Eligible consenting kidney transplant donors who are randomized to receive placebo will be given 1 placebo in morning and 1 in evening for 14 days prior to transplant date~Placebo: 1 capsule twice a day for 14 days prior to transplant date"
270701|NCT01329185|P2|Participant Flow|Valganciclovir|"Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date~Valganciclovir: Valganciclovir 450mg twice a day for 14 days prior to transplant date"
270702|NCT01329185|P1|Participant Flow|Placebo|"Eligible consenting kidney transplant donors who are randomized to receive placebo will be given 1 placebo in morning and 1 in evening for 14 days prior to transplant date~Placebo: 1 capsule twice a day for 14 days prior to transplant date"
270703|NCT01329185|O2|Outcome|Valganciclovir|"Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date~Valganciclovir: Valganciclovir 450mg twice a day for 14 days prior to transplant date"
270704|NCT01329185|O1|Outcome|Placebo|"Eligible consenting kidney transplant donors who are randomized to receive placebo will be given 1 placebo in morning and 1 in evening for 14 days prior to transplant date~Placebo: 1 capsule twice a day for 14 days prior to transplant date"
270705|NCT01329185|E2|Reported Event|Valganciclovir|"Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date~Valganciclovir: Valganciclovir 450mg twice a day for 14 days prior to transplant date"
270706|NCT01329185|E1|Reported Event|Placebo|"Eligible consenting kidney transplant donors who are randomized to receive placebo will be given 1 placebo in morning and 1 in evening for 14 days prior to transplant date~Placebo: 1 capsule twice a day for 14 days prior to transplant date"
270707|NCT01329029|B3|Baseline|Total|Total of all reporting groups
270708|NCT01329029|B2|Baseline|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270709|NCT01329029|B1|Baseline|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270710|NCT01329029|P2|Participant Flow|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270711|NCT01329029|P1|Participant Flow|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270712|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270713|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270714|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270715|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270904|NCT01328548|B3|Baseline|Total|Total of all reporting groups
292011|NCT01265667|O2|Outcome|Placebo|Placebo: orally q12h
270719|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270720|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270721|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270722|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270723|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270724|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270725|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270726|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270727|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270728|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270729|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270730|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270731|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270732|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270733|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270734|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270735|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270736|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270737|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270738|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270739|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270740|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270741|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270742|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270743|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270744|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270745|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270746|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270747|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270748|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270905|NCT01328548|B2|Baseline|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
270749|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270750|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270751|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270752|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270753|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270754|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270755|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270756|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270757|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270758|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270759|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270760|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270761|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270762|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270763|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270764|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270765|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270766|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270767|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270768|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270769|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270770|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270771|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270772|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270773|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270774|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270775|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270776|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270777|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270778|NCT01329029|E2|Reported Event|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270906|NCT01328548|B1|Baseline|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
270779|NCT01329029|E1|Reported Event|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
270780|NCT01328964|B4|Baseline|Total|Total of all reporting groups
270781|NCT01328964|B3|Baseline|Montelukast|Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma
270782|NCT01328964|B2|Baseline|Budesonide|Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
270783|NCT01328964|B1|Baseline|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
270784|NCT01328964|P3|Participant Flow|Montelukast|Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma
270785|NCT01328964|P2|Participant Flow|Budesonide|Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
270786|NCT01328964|P1|Participant Flow|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
270787|NCT01328964|O2|Outcome|Montelukast|Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma
270788|NCT01328964|O1|Outcome|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
270789|NCT01328964|O2|Outcome|Montelukast|Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma
270790|NCT01328964|O1|Outcome|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
270791|NCT01328964|O2|Outcome|Budesonide|Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
270792|NCT01328964|O1|Outcome|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
270793|NCT01328964|O2|Outcome|Budesonide|Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
270794|NCT01328964|O1|Outcome|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
270795|NCT01328964|E3|Reported Event|Montelukast|Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma
270796|NCT01328964|E2|Reported Event|Budesonide|Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
270797|NCT01328964|E1|Reported Event|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
270798|NCT01328951|B3|Baseline|Total|Total of all reporting groups
270799|NCT01328951|B2|Baseline|Early Erlotinib|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not EGFR targeted therapies) or BSC as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
270800|NCT01328951|B1|Baseline|Late Erlotinib|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
270801|NCT01328951|P2|Participant Flow|Early Erlotinib|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not epidermal growth factor receptor [EGFR] targeted therapies) or best supportive care (BSC) as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
270802|NCT01328951|P1|Participant Flow|Late Erlotinib|Participants received blinded placebo tablets orally (PO) once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
270803|NCT01328951|O2|Outcome|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
270804|NCT01328951|O1|Outcome|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
270805|NCT01328951|O2|Outcome|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
270806|NCT01328951|O1|Outcome|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
270807|NCT01328951|O2|Outcome|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
270970|NCT01328444|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
270808|NCT01328951|O1|Outcome|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
270809|NCT01328951|O2|Outcome|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
270810|NCT01328951|O1|Outcome|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
270811|NCT01328951|O2|Outcome|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
270812|NCT01328951|O1|Outcome|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
270813|NCT01328951|O2|Outcome|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
270814|NCT01328951|O1|Outcome|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
270815|NCT01328951|O2|Outcome|Early Erlotinib|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not EGFR targeted therapies) or BSC as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
270816|NCT01328951|O1|Outcome|Late Erlotinib|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
270817|NCT01328951|O2|Outcome|Early Erlotinib|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not EGFR targeted therapies) or BSC as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
270818|NCT01328951|O1|Outcome|Late Erlotinib|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
270819|NCT01328951|O2|Outcome|Early Erlotinib|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not EGFR targeted therapies) or BSC as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
270820|NCT01328951|O1|Outcome|Late Erlotinib|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
270821|NCT01328951|E4|Reported Event|Second-Line Chemotherapy (Early Erlotinib)|Participants who received blinded erlotinib and who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not EGFR targeted therapies) or BSC as chosen by the investigator. This treatment continued during the OLP until disease progression, death, or unacceptable toxicity.
270822|NCT01328951|E3|Reported Event|Second-Line Erlotinib (Late Erlotinib)|Participants who received blinded placebo and who demonstrated disease progression were unblinded and could receive second-line erlotinib as 150-mg tablets PO once daily, provided by the Sponsor. This treatment continued during the OLP until disease progression, death, or unacceptable toxicity.
270823|NCT01328951|E2|Reported Event|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
270824|NCT01328951|E1|Reported Event|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
270825|NCT01328873|B1|Baseline|Laboratory Testing|"All patients will receive the lab testing on bronchoscopy specimens~Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens"
270907|NCT01328548|P2|Participant Flow|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
270826|NCT01328873|P1|Participant Flow|Laboratory Testing|"All patients will receive the lab testing on bronchoscopy specimens~Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens"
270827|NCT01328873|O1|Outcome|Laboratory Testing|"All patients will receive the lab testing on bronchoscopy specimens~Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens"
270828|NCT01328873|O1|Outcome|Laboratory Testing|"All patients will receive the lab testing on bronchoscopy specimens~Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens"
270829|NCT01328873|O1|Outcome|Laboratory Testing|"All patients will receive the lab testing on bronchoscopy specimens~Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens"
270830|NCT01328873|O1|Outcome|Laboratory Testing|"All patients will receive the lab testing on bronchoscopy specimens~Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens"
270831|NCT01328873|O1|Outcome|Laboratory Testing|"Patients were evaluated by changes on the CT and categorized as follows:~Air space~ground glass/reticular nodular~nodular/cavitary~single patchy infiltrate~These were evaluated on CT scans and all units of measure are the same."
270832|NCT01328873|O1|Outcome|All Patients Will Receive Lab Testing on Bronchoscopy Specimen|
270833|NCT01328873|E1|Reported Event|Laboratory Testing|"All patients will receive the lab testing on bronchoscopy specimens~Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens"
270834|NCT01328782|B4|Baseline|Total|Total of all reporting groups
270835|NCT01328782|B3|Baseline|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
270836|NCT01328782|B2|Baseline|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
270837|NCT01328782|B1|Baseline|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
270838|NCT01328782|P3|Participant Flow|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
270839|NCT01328782|P2|Participant Flow|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
270840|NCT01328782|P1|Participant Flow|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
270841|NCT01328782|O3|Outcome|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
270842|NCT01328782|O2|Outcome|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
270843|NCT01328782|O1|Outcome|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
270844|NCT01328782|O3|Outcome|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
270845|NCT01328782|O2|Outcome|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
270846|NCT01328782|O1|Outcome|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
270847|NCT01328782|O3|Outcome|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
270848|NCT01328782|O2|Outcome|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
270849|NCT01328782|O1|Outcome|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
270850|NCT01328782|O3|Outcome|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
270851|NCT01328782|O2|Outcome|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
270852|NCT01328782|O1|Outcome|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
270853|NCT01328782|O3|Outcome|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
270854|NCT01328782|O2|Outcome|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
270855|NCT01328782|O1|Outcome|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
270856|NCT01328782|E3|Reported Event|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
270857|NCT01328782|E2|Reported Event|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
270858|NCT01328782|E1|Reported Event|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
270859|NCT01328769|B3|Baseline|Total|Total of all reporting groups
270860|NCT01328769|B2|Baseline|Placebo|Matching placebo dose 80mg once daily
270861|NCT01328769|B1|Baseline|Febuxostat|80mg daily
270862|NCT01328769|P2|Participant Flow|Placebo|Matching placebo dose 80mg once daily
270863|NCT01328769|P1|Participant Flow|Febuxostat|80mg once daily
270864|NCT01328769|O2|Outcome|Placebo|Matching placebo dose 80mg once daily
270865|NCT01328769|O1|Outcome|Febuxostat|80mg daily
270866|NCT01328769|O2|Outcome|Placebo|Matching placebo dose 80mg once daily
270867|NCT01328769|O1|Outcome|Febuxostat|80mg daily
270868|NCT01328769|E2|Reported Event|Placebo|
270869|NCT01328769|E1|Reported Event|Febuxostat|
270870|NCT01328756|B1|Baseline|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
270871|NCT01328756|P1|Participant Flow|Lisdexamfetamine Dimesylate|"Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 milligram (mg) capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.~At optimization period, participants started SPD489 30 mg and dose was titrated until acceptable response (30% reduction from baseline in ADHD Rating Scale-IV total score, clinical global impression-improvement [CGI-I]score of 1 or 2 with tolerable side effects) was achieved. Maximum dose was 70mg. Dose adjustments were done in dose maintenance period."
270872|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
270873|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
270874|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
270875|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
270876|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
270877|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
270878|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
270879|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
270880|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
270881|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
270882|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
270883|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
270884|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
270885|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
270886|NCT01328756|E1|Reported Event|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (Vyvanse, SPD489) 30 to 70 mg capsule once daily orally.
270887|NCT01328717|B1|Baseline|Intended Users of the System|Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
270888|NCT01328717|P1|Participant Flow|Intended Users of the System|Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
270889|NCT01328717|O1|Outcome|Intended Users of the System|Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
270890|NCT01328717|O1|Outcome|Intended Users of the System|Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
270891|NCT01328717|E1|Reported Event|Intended Users of the System|Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
270892|NCT01328574|B1|Baseline|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously"
270893|NCT01328574|P1|Participant Flow|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously"
270894|NCT01328574|O5|Outcome|TRC105 in Urothelial Carcinoma - Adverse Events - Grade 4|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously Grade 4 (life threatening) adverse events."
270895|NCT01328574|O4|Outcome|TRC105 in Urothelial Carcinoma - Adverse Events - Grade 3|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously Grade 3 (severe) adverse events."
270896|NCT01328574|O3|Outcome|TRC105 in Urothelial Carcinoma - Adverse Events - Grade 2|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously Grade 2 (moderate) adverse events."
270897|NCT01328574|O2|Outcome|TRC105 in Urothelial Carcinoma - Adverse Events - Grade 1|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously Grade 1 (mild) adverse events."
270898|NCT01328574|O1|Outcome|TRC105 in Urothelial Carcinoma - Adverse Events - All Grades|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously~Adverse events grades 1-4 (mild, moderate, severe and life threatening)."
270899|NCT01328574|O1|Outcome|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously"
270900|NCT01328574|O1|Outcome|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously"
270901|NCT01328574|O1|Outcome|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously"
270902|NCT01328574|O1|Outcome|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously"
271470|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
270908|NCT01328548|P1|Participant Flow|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
270909|NCT01328548|O2|Outcome|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
270910|NCT01328548|O1|Outcome|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
270911|NCT01328548|O2|Outcome|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
270912|NCT01328548|O1|Outcome|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
270913|NCT01328548|O2|Outcome|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
270914|NCT01328548|O1|Outcome|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
270915|NCT01328548|O2|Outcome|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
270916|NCT01328548|O1|Outcome|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
270917|NCT01328548|O2|Outcome|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
270918|NCT01328548|O1|Outcome|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
270919|NCT01328548|O2|Outcome|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
270920|NCT01328548|O1|Outcome|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
270921|NCT01328548|O2|Outcome|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
270922|NCT01328548|O1|Outcome|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
270923|NCT01328548|E2|Reported Event|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
270924|NCT01328548|E1|Reported Event|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
270925|NCT01328496|B3|Baseline|Total|Total of all reporting groups
270926|NCT01328496|B2|Baseline|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
270927|NCT01328496|B1|Baseline|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
270928|NCT01328496|P2|Participant Flow|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
270929|NCT01328496|P1|Participant Flow|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
270930|NCT01328496|O2|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
270940|NCT01328496|O1|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
270931|NCT01328496|O1|Outcome|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
270932|NCT01328496|O2|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
270933|NCT01328496|O1|Outcome|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
270934|NCT01328496|O1|Outcome|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
270935|NCT01328496|O2|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.~Intervention: Preparative Regimen Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
270936|NCT01328496|O1|Outcome|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
270937|NCT01328496|O2|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.~Intervention: Preparative Regimen Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
270938|NCT01328496|O1|Outcome|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
270939|NCT01328496|O1|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observationalal arm.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
270969|NCT01328444|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
270941|NCT01328496|O1|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
270942|NCT01328496|O1|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
270943|NCT01328496|O1|Outcome|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
270944|NCT01328496|E2|Reported Event|Observation Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
270945|NCT01328496|E1|Reported Event|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
270946|NCT01328444|B1|Baseline|All Study Treatments|Participants were randomized to receive a sequence consisting of 2 of the following treatments: UMEC/VI 125/25 µg , UMEC/VI 62.5/25 µg , UMEC 125 µg , UMEC 62.5 µg , VI 25 µg , or placebo QD via a DPI. Each treatment was administered in the morning for 12 weeks. The treatment periods were seperated by 14-day washout period.
270947|NCT01328444|P6|Participant Flow|UMEC 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
270948|NCT01328444|P5|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
270949|NCT01328444|P4|Participant Flow|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
270950|NCT01328444|P3|Participant Flow|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
270951|NCT01328444|P2|Participant Flow|UMEC 62.5 µg QD|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) QD via a DPI in the morning for 12 weeks.
270952|NCT01328444|P1|Participant Flow|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
270953|NCT01328444|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
270954|NCT01328444|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
270955|NCT01328444|O4|Outcome|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
270956|NCT01328444|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
270957|NCT01328444|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
270958|NCT01328444|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
270959|NCT01328444|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
270960|NCT01328444|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
270961|NCT01328444|O4|Outcome|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
270962|NCT01328444|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
270963|NCT01328444|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
270964|NCT01328444|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
270965|NCT01328444|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
270966|NCT01328444|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
270967|NCT01328444|O4|Outcome|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
270968|NCT01328444|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
270971|NCT01328444|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
270972|NCT01328444|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
270973|NCT01328444|O4|Outcome|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
270974|NCT01328444|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
270975|NCT01328444|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
270976|NCT01328444|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
270977|NCT01328444|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
270978|NCT01328444|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
270979|NCT01328444|O4|Outcome|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
270980|NCT01328444|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
270981|NCT01328444|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
270982|NCT01328444|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
270983|NCT01328444|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
270984|NCT01328444|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
270985|NCT01328444|O4|Outcome|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
270986|NCT01328444|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
270987|NCT01328444|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
270988|NCT01328444|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
270989|NCT01328444|E6|Reported Event|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
270990|NCT01328444|E5|Reported Event|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
270991|NCT01328444|E4|Reported Event|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
270992|NCT01328444|E3|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
270993|NCT01328444|E2|Reported Event|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
270994|NCT01328444|E1|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
270995|NCT01328431|B3|Baseline|Total|Total of all reporting groups
270996|NCT01328431|B2|Baseline|SBIRT+NRT|"Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.~Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor."
270997|NCT01328431|B1|Baseline|Standard Care|Subjects receive a brochure for the state's Smokers' Quitline only.
270998|NCT01328431|P2|Participant Flow|SBIRT+NRT|"Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.~Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor."
270999|NCT01328431|P1|Participant Flow|Standard Care|Subjects receive a brochure for the state's Smokers' Quitline only.
271000|NCT01328431|O2|Outcome|SBIRT+NRT|"Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.~Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor."
271001|NCT01328431|O1|Outcome|Standard Care|Subjects receive a brochure for the state's Smokers' Quitline only.
271052|NCT01328379|E2|Reported Event|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
271053|NCT01328379|E1|Reported Event|Placebo|placebo, twice daily
271054|NCT01328366|B1|Baseline|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
271088|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
271089|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
271002|NCT01328431|O2|Outcome|SBIRT+NRT|"Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.~Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor."
271003|NCT01328431|O1|Outcome|Standard Care|Subjects receive a brochure for the state's Smokers' Quitline only.
271004|NCT01328431|E2|Reported Event|SBIRT+NRT|"Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.~Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor."
271005|NCT01328431|E1|Reported Event|Standard Care|Subjects receive a brochure for the state's Smokers' Quitline only.
271006|NCT01328405|B3|Baseline|Total|Total of all reporting groups
271007|NCT01328405|B2|Baseline|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
271008|NCT01328405|B1|Baseline|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
271009|NCT01328405|P2|Participant Flow|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
271010|NCT01328405|P1|Participant Flow|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
271011|NCT01328405|O2|Outcome|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
271012|NCT01328405|O1|Outcome|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
271013|NCT01328405|O2|Outcome|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
271014|NCT01328405|O1|Outcome|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
271015|NCT01328405|O2|Outcome|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
271016|NCT01328405|O1|Outcome|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
271017|NCT01328405|O2|Outcome|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
271018|NCT01328405|O1|Outcome|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
271019|NCT01328405|O2|Outcome|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
271020|NCT01328405|O1|Outcome|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
271021|NCT01328405|E2|Reported Event|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
271022|NCT01328405|E1|Reported Event|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
271023|NCT01328379|B4|Baseline|Total|Total of all reporting groups
271024|NCT01328379|B3|Baseline|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
271025|NCT01328379|B2|Baseline|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
271026|NCT01328379|B1|Baseline|Placebo|placebo, twice daily
271027|NCT01328379|P3|Participant Flow|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
271028|NCT01328379|P2|Participant Flow|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
271029|NCT01328379|P1|Participant Flow|Placebo|placebo, twice daily
271030|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
271031|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
271032|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
271033|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
271034|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
271035|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
271036|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
271037|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
271038|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
271039|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
271040|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
271041|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
271042|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
271043|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
271044|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
271045|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
271046|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
271047|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
271048|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
271049|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
271050|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
271051|NCT01328379|E3|Reported Event|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
292012|NCT01265667|O1|Outcome|CF101 2 mg|CF101: orally q12h
271055|NCT01328366|P1|Participant Flow|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
271056|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
271057|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
271058|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
271059|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
271060|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
271061|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
271062|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
271063|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
271064|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
271065|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
271066|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
271067|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
271068|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
271069|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
271070|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
271071|NCT01328366|E1|Reported Event|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
271072|NCT01328184|B1|Baseline|Study Overall|A open label, two-period, fixed sequence trial. Patients received one tablet of Microgynon once daily for 14 days, immediately followed by one tablet of Microgynon once daily plus 25mg empa once daily for 7 days.
271073|NCT01328184|P1|Participant Flow|Study Overall|A open label, two-period, fixed sequence trial. Patients received one tablet of Microgynon once daily for 14 days, immediately followed by one tablet of Microgynon once daily plus 25mg empa once daily for 7 days.
271074|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
271075|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
271076|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
271077|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
271078|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
271079|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
271080|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
271081|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
271082|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
271083|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
271084|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
271085|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
271086|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
271087|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
271471|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
271090|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
271091|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
271092|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
271093|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
271094|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
271095|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
271096|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
271097|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
271098|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
271099|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
271100|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
271101|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
271102|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
271103|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
271104|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
271105|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
271106|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
271107|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
271108|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
271109|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
271110|NCT01328184|E2|Reported Event|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
271111|NCT01328184|E1|Reported Event|Microgynon|One tablet of Microgynon once daily for 14 days.
271112|NCT01328158|B1|Baseline|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271113|NCT01328158|P1|Participant Flow|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271114|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271115|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271116|NCT01328158|O3|Outcome|Lopinavir/Ritonavir: Baseline CDC Category Unknown|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271117|NCT01328158|O2|Outcome|Lopinavir/Ritonavir: Baseline CDC Category C|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271118|NCT01328158|O1|Outcome|Lopinavir/Ritonavir: Baseline CDC Category A|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271119|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271120|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271121|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271122|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271123|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271124|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271125|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271126|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271127|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271128|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271129|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271130|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271131|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271207|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
271132|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271133|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271134|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271135|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271136|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271137|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271138|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271139|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271140|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271141|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271142|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271143|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271144|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271145|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271146|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271147|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271148|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271149|NCT01328158|E1|Reported Event|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
271150|NCT01328080|B1|Baseline|Targeted UV-B|
271151|NCT01328080|P1|Participant Flow|Targeted UVB Phototherapy|All patients were randomly assigned to receive targeted UVB phototherapy 3 times a week for 16 weeks to either the right or the left side of the scalp. The untreated side served as an internal control until the end of week 8, after which both sides of the scalp were treated.
271152|NCT01328080|O1|Outcome|Targeted UVB Phototherapy|All patients were randomly assigned to receive targeted UVB phototherapy 3 times a week for 16 weeks to either the right or the left side of the scalp. The untreated side served as an internal control until the end of week 8, after which both sides of the scalp were treated.
271153|NCT01328080|E1|Reported Event|Targeted UVB Phototherapy|All patients were randomly assigned to receive targeted UVB phototherapy 3 times a week for 16 weeks to either the right or the left side of the scalp. The untreated side served as an internal control until the end of week 8, after which both sides of the scalp were treated.
271154|NCT01328054|B1|Baseline|Placebo and Lapatinib 2000 mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
271155|NCT01328054|P2|Participant Flow|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 milligrams (mg) (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
271156|NCT01328054|P1|Participant Flow|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
271157|NCT01328054|O1|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
271158|NCT01328054|O1|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
271159|NCT01328054|O1|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
271160|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000 mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
271161|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000 mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
271208|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
271209|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
271162|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000 mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
271163|NCT01328054|O1|Outcome|Placebo/ Lapatinib|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
271164|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000 mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
271165|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4
271166|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
271167|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000 mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
271168|NCT01328054|O2|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
271169|NCT01328054|O1|Outcome|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
271170|NCT01328054|O2|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4
271171|NCT01328054|O1|Outcome|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
271172|NCT01328054|O2|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
271173|NCT01328054|O1|Outcome|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
271174|NCT01328054|O2|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
271175|NCT01328054|O1|Outcome|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
271176|NCT01328054|O2|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
271177|NCT01328054|O1|Outcome|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
271178|NCT01328054|E2|Reported Event|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
271179|NCT01328054|E1|Reported Event|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
271180|NCT01328041|B1|Baseline|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
271181|NCT01328041|P1|Participant Flow|Dolutegravir 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice a day (BID).
271182|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
271183|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
271184|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
271185|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
271186|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
271187|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
271188|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
271189|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
271190|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
271191|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
271192|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
271193|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
271194|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
271195|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
271196|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
271197|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
271198|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
271199|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
271200|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
271201|NCT01328041|E1|Reported Event|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
271202|NCT01327989|B1|Baseline|Solitaire™ FR Device|Eligible subjects treated with the Solitaire™ FR device.
271203|NCT01327989|P1|Participant Flow|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
271204|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
271205|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
271206|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
271210|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
271211|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
271212|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
271213|NCT01327989|E1|Reported Event|Solitaire™ FR Device|Eligible subjects treated with the Solitaire™ FR device.
271214|NCT01327976|B3|Baseline|Total|Total of all reporting groups
271215|NCT01327976|B2|Baseline|Sham (Non-active Device)|"The Sham group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period.~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Control device will deliver no vBloc Therapy."
271216|NCT01327976|B1|Baseline|vBloc (Active Device)|"The vBloc group will receive a functional device that will deliver charge to the vagus nerve during the study period.~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Active device will deliver vBloc Therapy."
271217|NCT01327976|P2|Participant Flow|Sham (Non-active Device)|"The control group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period.~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Control device will deliver no vBloc Therapy."
271218|NCT01327976|P1|Participant Flow|vBloc (Active Device)|"The treatment group will receive a functional device that will deliver charge to the vagus nerve during the study period.~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Active device will deliver vBloc Therapy."
271219|NCT01327976|O2|Outcome|Sham (Non-active Device)|The Sham group received a device that dissipated charges into an electronic circuit within the device with no lead placement. Therefore, no charge was delivered to the vagus nerve during the study period.
271220|NCT01327976|O1|Outcome|vBloc (Active Device)|The vBloc group received an active, implantable, vagal blocking medical device (Maestro® Rechargeable System) that delivered charge to the intra-abdominal anterior and posterior vagal trunks during the study period
271221|NCT01327976|O2|Outcome|Sham (Non-active Device)|"The Sham group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Control device will deliver no vBlocTherapy"
271222|NCT01327976|O1|Outcome|vBloc (Active Device)|"The vBloc group will receive a functional device that will deliver charge to the vagus nerve during the study period~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Active device will deliver vBloc Therapy"
271223|NCT01327976|O2|Outcome|Sham (Non-active Device)|The Sham group received a device that dissipated charges into an electronic circuit within the device with no lead placement. Therefore, no charge was delivered to the vagus nerve during the study period.
271224|NCT01327976|O1|Outcome|vBloc (Active Device)|The vBloc group received an active, implantable, vagal blocking medical device (Maestro® Rechargeable System) that delivered charge to the intra-abdominal anterior and posterior vagal trunks during the study period
271225|NCT01327976|E2|Reported Event|Sham (Non-active Device)|"The control group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period.~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Control device will deliver no vBloc Therapy."
271226|NCT01327976|E1|Reported Event|vBloc (Active Device)|"The treatment group will receive a functional device that will deliver charge to the vagus nerve during the study period.~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Active device will deliver vBlocTherapy."
271227|NCT01327885|B3|Baseline|Total|Total of all reporting groups
271228|NCT01327885|B2|Baseline|Arm B: Dacarbazine|Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the Principal Investigator [PI] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
271229|NCT01327885|B1|Baseline|Arm A: Eribulin Mesylate|Eribulin mesylate at a dose of 1.4 mg/m^2 was administered intravenously (IV) as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
271230|NCT01327885|P2|Participant Flow|Arm B: Dacarbazine|Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the Principal Investigator [PI] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
271231|NCT01327885|P1|Participant Flow|Arm A: Eribulin Mesylate|Eribulin mesylate at a dose of 1.4 mg/m^2 was administered intravenously (IV) as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
271232|NCT01327885|O2|Outcome|Arm B: Dacarbazine|Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the PI or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
271233|NCT01327885|O1|Outcome|Arm A: Eribulin Mesylate|Eribulin mesylate at a dose of 1.4 mg/m^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
271234|NCT01327885|O2|Outcome|Arm B: Dacarbazine|Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the PI or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
271235|NCT01327885|O1|Outcome|Arm A: Eribulin Mesylate|Eribulin mesylate at a dose of 1.4 mg/m^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
271236|NCT01327885|O2|Outcome|Arm B: Dacarbazine|Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the PI or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
271315|NCT01327651|O6|Outcome|Cape Town, South Africa, Seroconverted Participant #6|#6 seroconverted participants in Cape Town, South Africa, time-driven arm
271237|NCT01327885|O1|Outcome|Arm A: Eribulin Mesylate|Eribulin mesylate at a dose of 1.4 mg/m^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
271238|NCT01327885|O2|Outcome|Arm B: Dacarbazine|Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the Principal Investigator [PI] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
271239|NCT01327885|O1|Outcome|Arm A: Eribulin Mesylate|Eribulin mesylate at a dose of 1.4 mg/m^2 was administered intravenously (IV) as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
271240|NCT01327885|E2|Reported Event|Arm B: Dacarbazine|Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the Principal Investigator [PI] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
271241|NCT01327885|E1|Reported Event|Arm A: Eribulin Mesylate|Eribulin mesylate at a dose of 1.4 mg/m^2 was administered intravenously (IV) as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
271242|NCT01327703|B1|Baseline|Entire Study Population|Includes randomized participants who received Panzytrat® 25,000 first and Kreon® 25,000 first.
271243|NCT01327703|P2|Participant Flow|Kreon® First, Then Panzytrat®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 Ph.Eur. units lipase/kg body weight/day.
271244|NCT01327703|P1|Participant Flow|Panzytrat® First, Then Kreon®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day.
271245|NCT01327703|O2|Outcome|Kreon® First, Then Panzytrat®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 Ph.Eur. units lipase/kg body weight/day.
271246|NCT01327703|O1|Outcome|Panzytrat® First, Then Kreon®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day.
271247|NCT01327703|O2|Outcome|Kreon® First, Then Panzytrat®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 Ph.Eur. units lipase/kg body weight/day.
271248|NCT01327703|O1|Outcome|Panzytrat® First, Then Kreon®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day.
271249|NCT01327703|O2|Outcome|Kreon®, First, Then Panzytrat®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 Ph.Eur. units lipase/kg body weight/day.
271250|NCT01327703|O1|Outcome|Panzytrat® First, Then Kreon®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day.
271251|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
271252|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
271253|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
271316|NCT01327651|O5|Outcome|Cape Town, South Africa, Seroconverted Participant #5|#5 seroconverted participants in Cape Town, South Africa, time-driven arm
271254|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
271255|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
271256|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
271257|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
271258|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
271259|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
271260|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
271261|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
271262|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
271263|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
271264|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
271265|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
271266|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
271267|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
271268|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
271269|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
271270|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
271271|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
271272|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
271273|NCT01327703|E2|Reported Event|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
271274|NCT01327703|E1|Reported Event|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
271275|NCT01327677|B3|Baseline|Total|Total of all reporting groups
271276|NCT01327677|B2|Baseline|IVPCA Fentanyl|"A patient can self-administer fentanyl intravenously with a Patient Controlled Analgesia (PCA) pump.~Fentanyl: 20mcg/demand dose with an 8 minute lock out"
271277|NCT01327677|B1|Baseline|PRN Fentanyl|"A nurse can administer up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.~Fentanyl: 25-50 mcg every 20 minutes"
271278|NCT01327677|P2|Participant Flow|PCA Fentanyl|"A patient can self-administer fentanyl intravenously using a Patient Controlled Analgesia (PCA) pump.~Fentanyl: 20mcg/demand dose with an 8 minute lock out"
271279|NCT01327677|P1|Participant Flow|PRN Fentanyl|"A nurse can administer up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.~Fentanyl: 25-50 mcg every 20 minutes"
271280|NCT01327677|O2|Outcome|PCA Fentanyl|"A patient can self-administer fentanyl intravenously with a Patient Controlled Analgesia (PCA) pump.~Fentanyl: 20mcg/demand dose with an 8 minute lock out"
271281|NCT01327677|O1|Outcome|PRN Fentanyl|"A nurse can administer up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.~Fentanyl: 25-50 mcg every 20 minutes"
271282|NCT01327677|O2|Outcome|PCA Fentanyl|"A patient can self-administer fentanyl intravenously with a Patient Controlled Analgesia (PCA) pump.~Fentanyl: 20mcg/demand dose with an 8 minute lock out"
271283|NCT01327677|O1|Outcome|PRN Fentanyl|"A nurse can administer up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.~Fentanyl: 25-50 mcg every 20 minutes"
271284|NCT01327677|O2|Outcome|Intravenous Patient-controlled Analgesia (IVPCA) Fentanyl|"Fentanyl will be given with a Patient Controlled Analgesia (PCA) pump.~Fentanyl: 20mcg/demand dose with an 8 minute lock out"
271285|NCT01327677|O1|Outcome|(Pro re Nata) PRN Fentanyl|"A nurse can give the patient up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.~Fentanyl: 25-50 mcg every 20 minutes"
271286|NCT01327677|O2|Outcome|PCA Fentanyl|"A patient can self-administer fentanyl intravenously with a Patient Controlled Analgesia (PCA) pump.~Fentanyl: 20mcg/demand dose with an 8 minute lock out"
271287|NCT01327677|O1|Outcome|PRN Fentanyl|"A nurse can administer up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.~Fentanyl: 25-50 mcg every 20 minutes"
271288|NCT01327677|E2|Reported Event|PCA Fentanyl|"A patient can self-administer fentanyl intravenously with a Patient Controlled Analgesia (PCA) pump.~Fentanyl: 20mcg/demand dose with an 8 minute lock out"
271289|NCT01327677|E1|Reported Event|PRN Fentanyl|"A nurse can administer up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.~Fentanyl: 25-50 mcg every 20 minutes"
271290|NCT01327651|B10|Baseline|Total|Total of all reporting groups
271291|NCT01327651|B9|Baseline|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271292|NCT01327651|B8|Baseline|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271293|NCT01327651|B7|Baseline|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271294|NCT01327651|B6|Baseline|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271295|NCT01327651|B5|Baseline|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271296|NCT01327651|B4|Baseline|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271297|NCT01327651|B3|Baseline|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271298|NCT01327651|B2|Baseline|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271299|NCT01327651|B1|Baseline|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271300|NCT01327651|P9|Participant Flow|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271301|NCT01327651|P8|Participant Flow|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271302|NCT01327651|P7|Participant Flow|Daily Dosing, Harlem|Harlem participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
271303|NCT01327651|P6|Participant Flow|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271304|NCT01327651|P5|Participant Flow|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors"
271305|NCT01327651|P4|Participant Flow|Daily Dosing, Bangkok|Bangkok participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
271306|NCT01327651|P3|Participant Flow|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271307|NCT01327651|P2|Participant Flow|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271308|NCT01327651|P1|Participant Flow|Daily Dosing, Cape Town|Cape Town participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
271309|NCT01327651|O12|Outcome|Harlem, United States, Seroconverted Participant #2|#2 seroconverted participants in Harlem, United States, daily arm
271310|NCT01327651|O11|Outcome|Harlem, United States, Seroconverted Participant #1|#1 seroconverted participants in Harlem, United States, not randomized
271311|NCT01327651|O10|Outcome|Bangkok, Thailand, Seroconverted Participant #2|#2 seroconverted participants in Bangkok, Thailand, not randomized
271312|NCT01327651|O9|Outcome|Bangkok, Thailand, Seroconverted Participant #1|#1 seroconverted participants in Bangkok, Thailand, not randomized
271313|NCT01327651|O8|Outcome|Cape Town, South Africa, Seroconverted Participant #8|#8 seroconverted participants in Cape Town, South Africa, event-driven arm
271314|NCT01327651|O7|Outcome|Cape Town, South Africa, Seroconverted Participant #7|#7 seroconverted participants in Cape Town, South Africa, event-driven arm
271317|NCT01327651|O4|Outcome|Cape Town, South Africa, Seroconverted Participant #4|#4 seroconverted participants in Cape Town, South Africa, daily arm
271318|NCT01327651|O3|Outcome|Cape Town, South Africa, Seroconverted Participant #3|#3 seroconverted participants in Cape Town, South Africa, not randomized
271319|NCT01327651|O2|Outcome|Cape Town, South Africa, Seroconverted Participant #2|#2 seroconverted participants in Cape Town, South Africa, not randomized
271320|NCT01327651|O1|Outcome|Cape Town, South Africa, Seroconverted Participant #1|#1 seroconverted participants in Cape Town, South Africa, not randomized
271321|NCT01327651|O12|Outcome|Harlem, United States, Seroconverted Participant #2|#2 seroconverted participants in Harlem, United States, daily arm
271322|NCT01327651|O11|Outcome|Harlem, United States, Seroconverted Participant #1|#1 seroconverted participants in Harlem, United States, not randomized
271323|NCT01327651|O10|Outcome|Bangkok, Thailand, Seroconverted Participant #2|#2 seroconverted participants in Bangkok, Thailand, not randomized
271324|NCT01327651|O9|Outcome|Bangkok, Thailand, Seroconverted Participant #1|#1 seroconverted participants in Bangkok, Thailand, not randomized
271325|NCT01327651|O8|Outcome|Cape Town, South Africa, Seroconverted Participant #8|#8 seroconverted participants in Cape Town, South Africa, event-driven arm
271326|NCT01327651|O7|Outcome|Cape Town, South Africa, Seroconverted Participant #7|#7 seroconverted participants in Cape Town, South Africa, event-driven arm
271327|NCT01327651|O6|Outcome|Cape Town, South Africa, Seroconverted Participant #6|#6 seroconverted participants in Cape Town, South Africa, time-driven arm
271328|NCT01327651|O5|Outcome|Cape Town, South Africa, Seroconverted Participant #5|#5 seroconverted participants in Cape Town, South Africa, time-driven arm
271329|NCT01327651|O4|Outcome|Cape Town, South Africa, Seroconverted Participant #4|#4 seroconverted participants in Cape Town, South Africa, daily arm
271330|NCT01327651|O3|Outcome|Cape Town, South Africa, Seroconverted Participant #3|#3 seroconverted participants in Cape Town, South Africa, not randomized
271331|NCT01327651|O2|Outcome|Cape Town, South Africa, Seroconverted Participant #2|#2 seroconverted participants in Cape Town, South Africa, not randomized
271332|NCT01327651|O1|Outcome|Cape Town, South Africa, Seroconverted Participant #1|#1 seroconverted participants in Cape Town, South Africa, not randomized
271333|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271334|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271335|NCT01327651|O7|Outcome|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271336|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271337|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271338|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271339|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271340|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271341|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271342|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271343|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271344|NCT01327651|O7|Outcome|Daily Dosing, Harlem|Harlem participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
271345|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271346|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors"
271458|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
271459|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
271347|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|Bangkok participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
271348|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271349|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271350|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|Cape Town participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
271351|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271352|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271353|NCT01327651|O7|Outcome|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271354|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271355|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271356|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271357|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271358|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271359|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271360|NCT01327651|O3|Outcome|Harlem, United States|Columbia University Medical Center Institutional Review Board in New York is the IRB of record for the New York site.
271361|NCT01327651|O2|Outcome|Bangkok, Thailand|The Institutional Review Board, Human Research Protection Office, US Centers for Disease Control and Prevention and the Ethical Review Committee for Research in Human Subjects, Department of Medical Sciences, Ministry of Public Health, Thailand are the IRBs of record for the Bangkok site
271362|NCT01327651|O1|Outcome|Cape Town, South Africa|The University of Cape Town in Cape Town is the IRB of record for the Cape Town site
271363|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271364|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271365|NCT01327651|O7|Outcome|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271366|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271367|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271368|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271369|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271370|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271371|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271372|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271373|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271374|NCT01327651|O7|Outcome|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271375|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271376|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271377|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271378|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271379|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271380|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271381|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271382|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271383|NCT01327651|O7|Outcome|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271384|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271385|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271386|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271387|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271388|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271389|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271390|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271391|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271392|NCT01327651|O7|Outcome|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271393|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
292013|NCT01265667|E2|Reported Event|Placebo|Placebo: orally q12h
271394|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271395|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271396|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271397|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271398|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271399|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271400|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271401|NCT01327651|O7|Outcome|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271402|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271403|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271404|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271405|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271406|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271407|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271408|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271409|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271410|NCT01327651|O7|Outcome|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271411|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271412|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271413|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271414|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271415|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271416|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271417|NCT01327651|E9|Reported Event|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271418|NCT01327651|E8|Reported Event|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271419|NCT01327651|E7|Reported Event|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271420|NCT01327651|E6|Reported Event|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271421|NCT01327651|E5|Reported Event|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271422|NCT01327651|E4|Reported Event|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271423|NCT01327651|E3|Reported Event|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271424|NCT01327651|E2|Reported Event|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271425|NCT01327651|E1|Reported Event|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
271426|NCT01327599|B1|Baseline|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
271427|NCT01327599|P1|Participant Flow|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
271428|NCT01327599|O1|Outcome|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
271429|NCT01327599|O1|Outcome|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
271430|NCT01327599|O1|Outcome|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
271431|NCT01327599|O1|Outcome|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
271432|NCT01327599|O1|Outcome|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
271433|NCT01327599|E1|Reported Event|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
271434|NCT01327547|B3|Baseline|Total|Total of all reporting groups
271435|NCT01327547|B2|Baseline|Placebo|Participants who received placebo in combination with HAART
271436|NCT01327547|B1|Baseline|Maraviroc|Participants who received maraviroc in combination with HAART
271437|NCT01327547|P2|Participant Flow|Placebo|Participants who received placebo in combination with HAART
271438|NCT01327547|P1|Participant Flow|Maraviroc|Participants who received maraviroc in combination with Highly active antiretroviral therapy (HAART)
271439|NCT01327547|O6|Outcome|Alkaline Phosphatase (ALK)|The p-value of change in ALK from baseline versus MVC Cavg at Week 48.
271440|NCT01327547|O5|Outcome|Fibroscan (FSCN)|The p-value of change in FSCN from baseline versus MVC Cavg at Week 48.
271441|NCT01327547|O4|Outcome|Enhanced Liver Fibrosis (ELF)|The p-value of change in ELF from baseline versus MVC Cavg at Week 48.
271442|NCT01327547|O3|Outcome|Bilirubin (BIL)|The p-value of change in BIL from baseline versus MVC Cavg at Week 48.
271443|NCT01327547|O2|Outcome|Alanine Transaminase (ALT)|The p-value of change in ALT levels from baseline versus MVC Cavg at Week 48.
271444|NCT01327547|O1|Outcome|Aspartate Transaminase (AST)|The p-value of change in AST levels from baseline versus MVC Cavg at Week 48.
271445|NCT01327547|O3|Outcome|Maraviroc 600 mg|Participants received Maraviroc 600 mg BID with a potent CYP3A4 inducer (in absence of inhibitor)
271446|NCT01327547|O2|Outcome|Maraviroc 300 mg|Participants received Maraviroc 300mg BID in the absence of a potent CYP3A4 inhibitor and inducer
271447|NCT01327547|O1|Outcome|Maraviroc 150 mg|Participants received Maraviroc 150 mg twice a day (BID) in combination with a potent CYP3A4 inhibitor
271448|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
271449|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
271450|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
271451|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
271452|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
271453|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
271454|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
271455|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
271456|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
271457|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
271472|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
271473|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
271474|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
271475|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
271476|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
271477|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
271478|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
271479|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
271480|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
271481|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
271482|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
271483|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
271484|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
271485|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
271486|NCT01327547|E2|Reported Event|Placebo|Participants who received placebo in combination with HAART
271487|NCT01327547|E1|Reported Event|Maraviroc|Participants who received maraviroc in combination with HAART
271488|NCT01327508|B3|Baseline|Total|Total of all reporting groups
271489|NCT01327508|B2|Baseline|Standard Nailing Instrumentation.|"Free-hand technique utilizes x-rays to find screw holes~Free-hand technique: Free-hand technique utilizes x-rays to find screw holes."
271490|NCT01327508|B1|Baseline|TRIGEN SURESHOT Distal Targeting|"TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.~TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system"
271491|NCT01327508|P2|Participant Flow|Standard Nailing Instrumentation.|"Free-hand technique utilizes x-rays to find screw holes~Free-hand technique: Free-hand technique utilizes x-rays to find screw holes."
271492|NCT01327508|P1|Participant Flow|TRIGEN SURESHOT Distal Targeting|"TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.~TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system"
271493|NCT01327508|O2|Outcome|Standard Nailing Instrumentation.|"Free-hand technique utilizes x-rays to find screw holes~Free-hand technique: Free-hand technique utilizes x-rays to find screw holes."
271494|NCT01327508|O1|Outcome|TRIGEN SURESHOT Distal Targeting|"TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.~TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system"
271495|NCT01327508|O2|Outcome|Standard Nailing Instrumentation.|"Free-hand technique utilizes x-rays to find screw holes~Free-hand technique: Free-hand technique utilizes x-rays to find screw holes."
271496|NCT01327508|O1|Outcome|TRIGEN SURESHOT Distal Targeting|"TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.~TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system"
271497|NCT01327508|E2|Reported Event|Standard Nailing Instrumentation.|"Free-hand technique utilizes x-rays to find screw holes~Free-hand technique: Free-hand technique utilizes x-rays to find screw holes."
271498|NCT01327508|E1|Reported Event|TRIGEN SURESHOT Distal Targeting|"TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.~TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system"
271499|NCT01327495|B7|Baseline|Total|Total of all reporting groups
271500|NCT01327495|B6|Baseline|Arm 6|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks~testosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271501|NCT01327495|B5|Baseline|Arm 5|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks~testosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271502|NCT01327495|B4|Baseline|Arm 4|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks~Testosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271503|NCT01327495|B3|Baseline|Arm 3|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks~Testosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271504|NCT01327495|B2|Baseline|Arm 2|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks~Testosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271505|NCT01327495|B1|Baseline|Arm 1|"Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks~placebo acyline: Placebo acyline subcutaneous injection every 2 weeks~placebo gel: daily placebo testosterone gel applied transdermally x 12 weeks"
271506|NCT01327495|P6|Participant Flow|Arm 6 (Acyline & 15g Testosterone Gel)|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks~testosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271507|NCT01327495|P5|Participant Flow|Arm 5 (Acyline & 10g Testosterone Gel)|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks~testosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271508|NCT01327495|P4|Participant Flow|Arm 4 (Acyline & 5g Testosterone Gel)|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks~Testosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271509|NCT01327495|P3|Participant Flow|Arm 3 (Acyline & 2.5g Testosterone Gel)|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks~Testosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271833|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
271510|NCT01327495|P2|Participant Flow|Arm 2 (Acyline & 1.25g Testosterone Gel)|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks~Testosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271511|NCT01327495|P1|Participant Flow|Arm 1 (Placebo Acyline & Placebo T Gel )|"Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks~placebo acyline: Placebo acyline subcutaneous injection every 2 weeks~placebo gel: daily placebo testosterone gel applied transdermally x 12 weeks"
271512|NCT01327495|O6|Outcome|Arm 6|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks~testosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271513|NCT01327495|O5|Outcome|Arm 5|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks~testosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271514|NCT01327495|O4|Outcome|Arm 4|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks~Testosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271515|NCT01327495|O3|Outcome|Arm 3|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks~Testosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271516|NCT01327495|O2|Outcome|Arm 2|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks~Testosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271517|NCT01327495|O1|Outcome|Arm 1|"Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks~placebo acyline: Placebo acyline subcutaneous injection every 2 weeks~placebo gel: daily placebo testosterone gel applied transdermally x 12 weeks"
271518|NCT01327495|O6|Outcome|Arm 6|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks~testosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271519|NCT01327495|O5|Outcome|Arm 5|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks~testosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271520|NCT01327495|O4|Outcome|Arm 4|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks~Testosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271521|NCT01327495|O3|Outcome|Arm 3|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks~Testosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271522|NCT01327495|O2|Outcome|Arm 2|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks~Testosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271523|NCT01327495|O1|Outcome|Arm 1|"Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks~placebo acyline: Placebo acyline subcutaneous injection every 2 weeks~placebo gel: daily placebo testosterone gel applied transdermally x 12 weeks"
271524|NCT01327495|O6|Outcome|Arm 6|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks~testosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271525|NCT01327495|O5|Outcome|Arm 5|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks~testosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271526|NCT01327495|O4|Outcome|Arm 4|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks~Testosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271527|NCT01327495|O3|Outcome|Arm 3|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks~Testosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271528|NCT01327495|O2|Outcome|Arm 2|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks~Testosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271529|NCT01327495|O1|Outcome|Arm 1|"Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks~placebo acyline: Placebo acyline subcutaneous injection every 2 weeks~placebo gel: daily placebo testosterone gel applied transdermally x 12 weeks"
271530|NCT01327495|O6|Outcome|Arm 6|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks~testosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271531|NCT01327495|O5|Outcome|Arm 5|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks~testosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271532|NCT01327495|O4|Outcome|Arm 4|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks~Testosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271533|NCT01327495|O3|Outcome|Arm 3|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks~Testosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271534|NCT01327495|O2|Outcome|Arm 2|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks~Testosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271535|NCT01327495|O1|Outcome|Arm 1|"Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks~placebo acyline: Placebo acyline subcutaneous injection every 2 weeks~placebo gel: daily placebo testosterone gel applied transdermally x 12 weeks"
271536|NCT01327495|O6|Outcome|Arm 6|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks~testosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271537|NCT01327495|O5|Outcome|Arm 5|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks~testosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271538|NCT01327495|O4|Outcome|Arm 4|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks~Testosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271539|NCT01327495|O3|Outcome|Arm 3|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks~Testosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271540|NCT01327495|O2|Outcome|Arm 2|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks~Testosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271541|NCT01327495|O1|Outcome|Arm 1|"Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks~placebo acyline: Placebo acyline subcutaneous injection every 2 weeks~placebo gel: daily placebo testosterone gel applied transdermally x 12 weeks"
271542|NCT01327495|O6|Outcome|Arm 6|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks~testosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271543|NCT01327495|O5|Outcome|Arm 5|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks~testosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271544|NCT01327495|O4|Outcome|Arm 4|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks~Testosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271545|NCT01327495|O3|Outcome|Arm 3|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks~Testosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271546|NCT01327495|O2|Outcome|Arm 2|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks~Testosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271547|NCT01327495|O1|Outcome|Arm 1|"Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks~placebo acyline: Placebo acyline subcutaneous injection every 2 weeks~placebo gel: daily placebo testosterone gel applied transdermally x 12 weeks"
271548|NCT01327495|O6|Outcome|Arm 6|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks~testosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271549|NCT01327495|O5|Outcome|Arm 5|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks~testosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271550|NCT01327495|O4|Outcome|Arm 4|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks~Testosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271551|NCT01327495|O3|Outcome|Arm 3|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks~Testosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271552|NCT01327495|O2|Outcome|Arm 2|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks~Testosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271553|NCT01327495|O1|Outcome|Arm 1|"Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks~placebo acyline: Placebo acyline subcutaneous injection every 2 weeks~placebo gel: daily placebo testosterone gel applied transdermally x 12 weeks"
271554|NCT01327495|O6|Outcome|Arm 6|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks~testosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271555|NCT01327495|O5|Outcome|Arm 5|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks~testosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271556|NCT01327495|O4|Outcome|Arm 4|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks~Testosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271557|NCT01327495|O3|Outcome|Arm 3|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks~Testosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271558|NCT01327495|O2|Outcome|Arm 2|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks~Testosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271559|NCT01327495|O1|Outcome|Arm 1|"Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks~placebo acyline: Placebo acyline subcutaneous injection every 2 weeks~placebo gel: daily placebo testosterone gel applied transdermally x 12 weeks"
271560|NCT01327495|O6|Outcome|Arm 6|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks~testosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271561|NCT01327495|O5|Outcome|Arm 5|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks~testosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271562|NCT01327495|O4|Outcome|Arm 4|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks~Testosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271563|NCT01327495|O3|Outcome|Arm 3|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks~Testosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
292014|NCT01265667|E1|Reported Event|CF101 2 mg|CF101: orally q12h
271564|NCT01327495|O2|Outcome|Arm 2|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks~Testosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271565|NCT01327495|O1|Outcome|Arm 1|"Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks~placebo acyline: Placebo acyline subcutaneous injection every 2 weeks~placebo gel: daily placebo testosterone gel applied transdermally x 12 weeks"
271566|NCT01327495|O6|Outcome|Arm 6|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks~testosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271567|NCT01327495|O5|Outcome|Arm 5|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks~testosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271568|NCT01327495|O4|Outcome|Arm 4|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks~Testosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271569|NCT01327495|O3|Outcome|Arm 3|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks~Testosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271570|NCT01327495|O2|Outcome|Arm 2|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks~Testosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271571|NCT01327495|O1|Outcome|Arm 1|"Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks~placebo acyline: Placebo acyline subcutaneous injection every 2 weeks~placebo gel: daily placebo testosterone gel applied transdermally x 12 weeks"
271572|NCT01327495|O6|Outcome|Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g|Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks & daily 1% testosterone (T) gel 15g applied transdermally for 12 weeks.
271573|NCT01327495|O5|Outcome|Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g|Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks & daily 1% testosterone (T) gel 10g applied transdermally for 12 weeks.
271574|NCT01327495|O4|Outcome|Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g|Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks & daily 1% testosterone (T) gel 5g applied transdermally for 12 weeks.
271575|NCT01327495|O3|Outcome|Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5|Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks & daily 1% testosterone (T) gel 2.5g applied transdermally for 12 weeks.
271576|NCT01327495|O2|Outcome|Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g|Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks & daily 1% testosterone (T) gel 1.25g applied transdermally for 12 weeks.
271577|NCT01327495|O1|Outcome|Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel|Placebo acyline subcutaneous injection every 2 weeks for 12 weeks & daily placebo testosterone (T) gel applied transdermally for 12 weeks.
271578|NCT01327495|O6|Outcome|Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g|Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks & daily 1% testosterone (T) gel 15g applied transdermally for 12 weeks.
271579|NCT01327495|O5|Outcome|Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g|Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks & daily 1% testosterone (T) gel 10g applied transdermally for 12 weeks.
271580|NCT01327495|O4|Outcome|Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g|Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks & daily 1% testosterone (T) gel 5g applied transdermally for 12 weeks.
271581|NCT01327495|O3|Outcome|Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5|Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks & daily 1% testosterone (T) gel 2.5g applied transdermally for 12 weeks.
271582|NCT01327495|O2|Outcome|Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g|Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks & daily 1% testosterone (T) gel 1.25g applied transdermally for 12 weeks.
271583|NCT01327495|O1|Outcome|Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel|Placebo acyline subcutaneous injection every 2 weeks for 12 weeks & daily placebo testosterone (T) gel applied transdermally for 12 weeks.
271584|NCT01327495|O6|Outcome|Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g|Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks & daily 1% testosterone (T) gel 15g applied transdermally for 12 weeks.
271585|NCT01327495|O5|Outcome|Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g|Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks & daily 1% testosterone (T) gel 10g applied transdermally for 12 weeks.
271586|NCT01327495|O4|Outcome|Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g|Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks & daily 1% testosterone (T) gel 5g applied transdermally for 12 weeks.
271587|NCT01327495|O3|Outcome|Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5|Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks & daily 1% testosterone (T) gel 2.5g applied transdermally for 12 weeks.
271588|NCT01327495|O2|Outcome|Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g|Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks & daily 1% testosterone (T) gel 1.25g applied transdermally for 12 weeks.
271589|NCT01327495|O1|Outcome|Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel|Placebo acyline subcutaneous injection every 2 weeks for 12 weeks & daily placebo testosterone (T) gel applied transdermally for 12 weeks.
271590|NCT01327495|O6|Outcome|Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g|Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks & daily 1% testosterone (T) gel 15g applied transdermally for 12 weeks.
271591|NCT01327495|O5|Outcome|Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g|Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks & daily 1% testosterone (T) gel 10g applied transdermally for 12 weeks.
271592|NCT01327495|O4|Outcome|Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g|Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks & daily 1% testosterone (T) gel 5g applied transdermally for 12 weeks.
271593|NCT01327495|O3|Outcome|Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5|Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks & daily 1% testosterone (T) gel 2.5g applied transdermally for 12 weeks.
272249|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
271594|NCT01327495|O2|Outcome|Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g|Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks & daily 1% testosterone (T) gel 1.25g applied transdermally for 12 weeks.
271595|NCT01327495|O1|Outcome|Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel|Placebo acyline subcutaneous injection every 2 weeks for 12 weeks & daily placebo testosterone (T) gel applied transdermally for 12 weeks.
271596|NCT01327495|E6|Reported Event|Arm 6|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks~testosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271597|NCT01327495|E5|Reported Event|Arm 5|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks~testosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271598|NCT01327495|E4|Reported Event|Arm 4|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks~Testosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271599|NCT01327495|E3|Reported Event|Arm 3|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks~Testosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271600|NCT01327495|E2|Reported Event|Arm 2|"Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks~Testosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks~Acyline: 300 ug/kg subcutaneous injection every 2 weeks"
271601|NCT01327495|E1|Reported Event|Arm 1|"Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks~placebo acyline: Placebo acyline subcutaneous injection every 2 weeks~placebo gel: daily placebo testosterone gel applied transdermally x 12 weeks"
271602|NCT01327482|B1|Baseline|Raltegravir|Healthy volunteers who had regular menses and were not on hormonal contraception
271603|NCT01327482|P1|Participant Flow|Raltegravir|Healthy volunteers who had regular menses and were not on hormonal contraception
271604|NCT01327482|O1|Outcome|Raltegravir|Healthy volunteers who had regular menses and were not on hormonal contraception
271605|NCT01327482|O1|Outcome|Raltegravir|Healthy volunteers who had regular menses and were not on hormonal contraception
271606|NCT01327482|E1|Reported Event|Raltegravir|Healthy volunteers who had regular menses and were not on hormonal contraception
271607|NCT01327339|B1|Baseline|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
271608|NCT01327339|P1|Participant Flow|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 milligrams (mg), 1 mg, 2 mg of ropinirole administered once daily. All subjects will be administered of Requip in normal prescription use. Dosage regimen can be changed by the investigator according to the prescribing information.
271609|NCT01327339|O1|Outcome|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
271610|NCT01327339|O1|Outcome|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
271611|NCT01327339|O1|Outcome|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
271612|NCT01327339|E1|Reported Event|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
271613|NCT01327313|B5|Baseline|Total|Total of all reporting groups
271614|NCT01327313|B4|Baseline|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271615|NCT01327313|B3|Baseline|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271616|NCT01327313|B2|Baseline|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271617|NCT01327313|B1|Baseline|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271618|NCT01327313|P4|Participant Flow|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271619|NCT01327313|P3|Participant Flow|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271620|NCT01327313|P2|Participant Flow|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271621|NCT01327313|P1|Participant Flow|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271622|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271623|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271624|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271625|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271626|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271834|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
271627|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271628|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271629|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271630|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271631|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271632|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271633|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271634|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271635|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271636|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271637|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271638|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271639|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271640|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271641|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271642|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271643|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271644|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271645|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271646|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271647|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271648|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271649|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271650|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271651|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271652|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271653|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271654|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271655|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271656|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271657|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271658|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271659|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271660|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271661|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271662|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271663|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271664|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271665|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271666|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271667|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271668|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271669|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271670|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271671|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271672|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271673|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271674|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271675|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271676|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271677|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271678|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271679|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271680|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271681|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271682|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271683|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271684|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271685|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271686|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271687|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271688|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271689|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271690|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271691|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271692|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271693|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271694|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271695|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271696|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271697|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271698|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271699|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271700|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271701|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271702|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271703|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271704|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271705|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271706|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271707|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271708|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271709|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271710|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271711|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271712|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271713|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271714|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271715|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271716|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271717|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271718|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271719|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271720|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271721|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271722|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271723|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271724|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271725|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271726|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271727|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271728|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271729|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271730|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271731|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271732|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271733|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271734|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271735|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271736|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271737|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271738|NCT01327313|E4|Reported Event|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271739|NCT01327313|E3|Reported Event|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271740|NCT01327313|E2|Reported Event|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271741|NCT01327313|E1|Reported Event|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
271742|NCT01327300|B1|Baseline|All Study Participants|All participants were randomized to receive both mesalamine and placebo.
271743|NCT01327300|P2|Participant Flow|Placebo Then Mesalamine|"This group will receive the Placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm.~Placebo : 4 capsules (.375 gm sugar pill capsules) administered orally once a day. This group will receive the placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm."
271744|NCT01327300|P1|Participant Flow|Mesalamine Then Placebo|"This group received the drug Mesalamine for 12 weeks then a wash out for 3 weeks prior to crossing over to the placebo arm.~Mesalamine : Apriso is a 5-ASA drug with Intellicor ™ extended-release delivery technology. A 1.5 gram dosage of Apriso (equaling four 375 mg capsules) once a day will be administered orally for a period of 12 weeks followed by a 3 week wash out prior to crossing over to the placebo arm."
271745|NCT01327300|O2|Outcome|Placebo|"This group received the placebo for 12 weeks and after a 12 week treatment period, the ratio of lactulose to mannitol was measured.~Two patients in this cross-over study did not provide a 24 hour urine sample needed to obtain the lactulose /mannitol ratio."
271746|NCT01327300|O1|Outcome|Mesalamine|This group received the drug Mesalamine for 12 weeks and after a 12 week treatment period, the ratio of lactulose to mannitol was measured.
271747|NCT01327300|O2|Outcome|Placebo|This group will receive the Placebo for 12 weeks. Comparison of the change in HADS score after 12 weeks of placebo is made to baseline score.
271748|NCT01327300|O1|Outcome|Mesalamine|This group received the drug Mesalamine for 12 weeks . Comparison of the change in HADS score after 12 weeks of mesalamine is made to baseline score.
271749|NCT01327300|O2|Outcome|Placebo|"This group will receive the Placebo for 12 weeks.~The data below show the change in IBS-QOL scores from baseline after 12 weeks of intervention."
271750|NCT01327300|O1|Outcome|Mesalamine|"This group received the drug Mesalamine for 12 weeks.~The data below show the change in IBS-QOL scores from baseline after 12 weeks of intervention."
271751|NCT01327300|O2|Outcome|Placebo|"This group will receive the Placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm.~Values reported at the baseline FBDSI score minus the 12 week FBDSI score with placebo."
271752|NCT01327300|O1|Outcome|Mesalamine|"This group received the drug Mesalamine for 12 weeks then a wash out for 3 weeks prior to crossing over to the placebo arm.~Data is reported as baseline value minus 12 week mean FBDSI value with mesalamine."
271835|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
271753|NCT01327300|O2|Outcome|Placebo|"This group will receive the Placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm.~The data below reflect the change in the increase in inflammation with regards to increased mast cells, eosinophils counts and number of activated T lymphocytes after 12 week mesalamine from baseline level of inflammation"
271754|NCT01327300|O1|Outcome|Mesalamine|"This group received the drug Mesalamine for 12 weeks then a wash out for 3 weeks prior to crossing over to the placebo arm.~The data below reflect the change in the increase in inflammation with regards to increased mast cells, eosinophils counts and number of activated T lymphocytes after 12 week mesalamine from baseline level of inflammation."
271755|NCT01327300|O2|Outcome|Placebo|"This group will receive the Placebo for 12 weeks.~Placebo : 4 capsules (.375 gm sugar pill capsules) administered orally once a day. This group will receive the placebo for 12 weeks."
271756|NCT01327300|O1|Outcome|Mesalamine|This group received the drug Mesalamine for 12 weeks Mesalamine : Apriso is a 5-ASA drug with Intellicor ™ extended-release delivery technology. A 1.5 gram dosage of Apriso (equaling four 375 mg capsules) once a day will be administered orally for a period of 12 weeks
271757|NCT01327300|E2|Reported Event|Placebo Then Mesalamine|"This group will receive the Placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm.~Placebo : 4 capsules (.375 gm sugar pill capsules) administered orally once a day. This group will receive the placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm."
271758|NCT01327300|E1|Reported Event|Mesalamine Then Placebo|"This group received the drug Mesalamine for 12 weeks then a wash out for 3 weeks prior to crossing over to the placebo arm.~Mesalamine : Apriso is a 5-ASA drug with Intellicor ™ extended-release delivery technology. A 1.5 gram dosage of Apriso (equaling four 375 mg capsules) once a day will be administered orally for a period of 12 weeks followed by a 3 week wash out prior to crossing over to the placebo arm."
271759|NCT01327274|B1|Baseline|Treatment Arm|This is a non-randomized study in which otherwise healthy patients, ages 8-14, with severe pectus excavatum (PSI > 3.5) will undergo the interventional treatment by having outpatient surgery, the Magnetic Mini-Mover procedure, to both place and later explant the experimental Magnimplant or Magnetic Mini-Mover device. After surgery and recovery, all subjects will be fitted for an orthotic brace, which houses the external magnet and records brace-wear compliance. They will undergo 3MP treatment for 24 months. Patients will be seen in clinic at least monthly until treatment is complete.
271760|NCT01327274|P1|Participant Flow|Treatment Arm|"This is a non-randomized study in which otherwise healthy patients, ages 8-14, with severe pectus excavatum (PSI > 3.5) underwent the Magnetic Mini-Mover procedure. The internal magnet, or Magnimplant was implanted on the sternum. After surgery and recovery, all subjects were fitted for an orthotic brace, the Magnatract, which is secured to the patient’s chest wall by the attractive force between the coupled internal and external magnets and produces an outward force on the sternum to correct the pectus deformity."
271761|NCT01327274|O1|Outcome|Treatment Arm|All patients who underwent the Magnetic Mini-Mover Procedure.
271762|NCT01327274|O1|Outcome|Treatment Arm|All patients who underwent the Magnetic Mini-Mover Procedure.
271763|NCT01327274|O1|Outcome|Treatment Arm|All patients who underwent the Magnetic Mini-Mover Procedure.
271764|NCT01327274|O1|Outcome|Treatment Arm|All patients who underwent the Magnetic Mini-Mover Procedure
271765|NCT01327274|E1|Reported Event|Treatment Arm|Magnetic Mini-Mover Procedure (Magnimplant): This is a non-randomized study in which otherwise healthy patients, ages 8-14, with severe pectus excavatum (PSI > 3.5) will undergo the Magnetic Mini-Mover procedure outpatient surgery to both place and later explant the Magnimplant or Magnetic Mini-Mover device. Patients will be required to wear a custom-fitted orthotic brace, which houses the external magnet and records brace-wear compliance. They will undergo 3MP treatment for 24 months.
271766|NCT01327053|B3|Baseline|Total|Total of all reporting groups
271767|NCT01327053|B2|Baseline|LDE225 800 mg|The study is double blinded and will enroll at least 100 evaluable patients in the 800 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271768|NCT01327053|B1|Baseline|LDE225 200 mg|The study is double blinded and will enroll at least 50 evaluable patients in the 200 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271769|NCT01327053|P2|Participant Flow|LDE225 800 mg|The study is double blinded and will enroll at least 100 evaluable patients in the 800 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271770|NCT01327053|P1|Participant Flow|LDE225 200 mg|The study is double blinded and will enroll at least 50 evaluable patients in the 200 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271771|NCT01327053|O4|Outcome|LDE225 800mg mBCC|The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271772|NCT01327053|O3|Outcome|LDE225 200mg mBCC|The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271773|NCT01327053|O2|Outcome|LDE225 800mg laBCC|The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
292015|NCT01265615|B5|Baseline|Total|Total of all reporting groups
271774|NCT01327053|O1|Outcome|LDE225 200 mg laBCC|The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271775|NCT01327053|O4|Outcome|LDE225 800mg mBCC|The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271776|NCT01327053|O3|Outcome|LDE225 200mg mBCC|The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271777|NCT01327053|O2|Outcome|LDE225 800mg laBCC|The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271778|NCT01327053|O1|Outcome|LDE225 200 mg laBCC|The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271779|NCT01327053|O4|Outcome|LDE225 800mg mBCC|The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271780|NCT01327053|O3|Outcome|LDE225 200mg mBCC|The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271781|NCT01327053|O2|Outcome|LDE225 800mg laBCC|The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271782|NCT01327053|O1|Outcome|LDE225 200 mg laBCC|The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271783|NCT01327053|O4|Outcome|LDE225 800mg mBCC|The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271784|NCT01327053|O3|Outcome|LDE225 200mg mBCC|The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271785|NCT01327053|O2|Outcome|LDE225 800mg laBCC|The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271786|NCT01327053|O1|Outcome|LDE225 200 mg laBCC|The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271787|NCT01327053|O4|Outcome|LDE225 800mg mBCC|The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271788|NCT01327053|O3|Outcome|LDE225 200mg mBCC|The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271789|NCT01327053|O2|Outcome|LDE225 800mg laBCC|The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271790|NCT01327053|O1|Outcome|LDE225 200 mg laBCC|The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271791|NCT01327053|O4|Outcome|LDE225 800mg mBCC|The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271792|NCT01327053|O3|Outcome|LDE225 200mg mBCC|The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271836|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
272179|NCT01324947|O1|Outcome|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
271793|NCT01327053|O2|Outcome|LDE225 800mg laBCC|The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271794|NCT01327053|O1|Outcome|LDE225 200 mg laBCC|The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271795|NCT01327053|E2|Reported Event|LDE225 800 mg qd|The study is double blinded and will enroll at least 100 evaluable patients in the 800 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271796|NCT01327053|E1|Reported Event|LDE225 200 mg qd|The study is double blinded and will enroll at least 50 evaluable patients in the 200 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
271797|NCT01326962|B1|Baseline|Tocilizumab|Participants received Tocilizumab 8 milligram per kilogram (mg/kg) intravenously (IV) every 4 weeks for a total of 6 infusions up to Week 20. A follow-up visit at Week 24 was planned, after which evaluation of responders was done. Good/moderate EULAR responders continued receiving Tocilizumab every 4 weeks, till 1 year treatment or commercial availability.
271798|NCT01326962|P1|Participant Flow|Tocilizumab|Participants received Tocilizumab 8 milligram per kilogram (mg/kg) intravenously (IV) every 4 weeks for a total of 6 infusions up to Week 20. A follow-up visit at Week 24 was planned, after which evaluation of responders was done. Good/moderate EULAR responders continued receiving Tocilizumab every 4 weeks, till 1 year treatment or commercial availability.
271799|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
271800|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
271801|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
271802|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
271803|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
271804|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
271805|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
271806|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
271807|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
271808|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
271809|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
271810|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
271811|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
271812|NCT01326962|E1|Reported Event|Tocilizumab|Participants received Tocilizumab 8 milligram per kilogram (mg/kg) intravenously (IV) every 4 weeks for a total of 6 infusions up to Week 20. A follow-up visit at Week 24 was planned, after which evaluation of responders was done. Good/moderate EULAR responders continued receiving Tocilizumab every 4 weeks, till 1 year treatment or commercial availability.
271813|NCT01326910|B3|Baseline|Total|Total of all reporting groups
271814|NCT01326910|B2|Baseline|19306-137|Marketed Topical cream applied twice daily (or as needed)
271815|NCT01326910|B1|Baseline|19306-127|Experimental Topical cream applied twice daily (or as needed)
271816|NCT01326910|P2|Participant Flow|19306-137|Marketed Topical cream applied twice daily (or as needed)
271817|NCT01326910|P1|Participant Flow|19306-127|Experimental Topical cream applied twice daily (or as needed)
271818|NCT01326910|O2|Outcome|19306-137|Marketed Topical cream applied twice daily (or as needed)
271819|NCT01326910|O1|Outcome|19306-127|Experimental Topical cream applied twice daily (or as needed)
271820|NCT01326910|O2|Outcome|19306-137|Marketed Topical cream applied twice daily (or as needed)
271821|NCT01326910|O1|Outcome|19306-127|Experimental Topical cream applied twice daily (or as needed)
271822|NCT01326910|O2|Outcome|19306-137|Marketed Topical cream applied twice daily (or as needed)
271823|NCT01326910|O1|Outcome|19306-127|Experimental Topical cream applied twice daily (or as needed)
271824|NCT01326910|O2|Outcome|19306-137|Marketed Topical cream applied twice daily (or as needed)
271825|NCT01326910|O1|Outcome|19306-127|Experimental Topical cream applied twice daily (or as needed)
271826|NCT01326910|E2|Reported Event|19306-137|Marketed Topical cream applied twice daily (or as needed)
271827|NCT01326910|E1|Reported Event|19306-127|Experimental Topical cream applied twice daily (or as needed)
271828|NCT01326845|B3|Baseline|Total|Total of all reporting groups
271829|NCT01326845|B2|Baseline|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
271830|NCT01326845|B1|Baseline|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
271831|NCT01326845|P2|Participant Flow|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
271832|NCT01326845|P1|Participant Flow|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
271837|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
271838|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
271839|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
271840|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
271841|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
271842|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
271843|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
271844|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
271845|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
271846|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
271847|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
271848|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
271849|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
271850|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
271851|NCT01326845|E2|Reported Event|ICL pm|ICL pm
271852|NCT01326845|E1|Reported Event|ICL am|ICL am
271853|NCT01326533|B3|Baseline|Total|Total of all reporting groups
271854|NCT01326533|B2|Baseline|Placebo|Placebo daily
271855|NCT01326533|B1|Baseline|Hydroxychloroquine|Hydroxychloroquine sulfate PO 400 mg daily
271856|NCT01326533|P2|Participant Flow|Placebo|13 weeks of placebo PO
271857|NCT01326533|P1|Participant Flow|Hydroxychloroquine|13 weeks of hydroxychloroquine sulfate PO 400 mg/day
271858|NCT01326533|O2|Outcome|Placebo|PO daily for 13 weeks
271859|NCT01326533|O1|Outcome|Hydroxychloroquine|400 mg PO daily for 13 weeks
271860|NCT01326533|O2|Outcome|Placebo|PO daily for 13 weeks
271861|NCT01326533|O1|Outcome|Hydroxychloroquine|400 mg PO daily for 13 weeks
271862|NCT01326533|E2|Reported Event|Placebo|Placebo PO
271863|NCT01326533|E1|Reported Event|Hydroxychloroquine|Hydroxychloroquine sulfate PO 400mg/day
271864|NCT01326026|B3|Baseline|Total|Total of all reporting groups
271865|NCT01326026|B2|Baseline|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
271866|NCT01326026|B1|Baseline|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
271867|NCT01326026|P2|Participant Flow|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
271868|NCT01326026|P1|Participant Flow|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
271869|NCT01326026|O2|Outcome|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
271870|NCT01326026|O1|Outcome|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
271871|NCT01326026|O2|Outcome|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
271872|NCT01326026|O1|Outcome|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
271873|NCT01326026|O2|Outcome|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
271979|NCT01325623|O1|Outcome|% Sensitivity|Total number of seizures detected by M106 divided by the total number of seizures reported (investigator + confirmation by triple review) during the EMU stay
271874|NCT01326026|O1|Outcome|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
271875|NCT01326026|O2|Outcome|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
271876|NCT01326026|O1|Outcome|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
271877|NCT01326026|O2|Outcome|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
271878|NCT01326026|O1|Outcome|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
271879|NCT01326026|E2|Reported Event|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
271880|NCT01326026|E1|Reported Event|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
271881|NCT01325870|B4|Baseline|Total|Total of all reporting groups
271882|NCT01325870|B3|Baseline|S-CPR|S-CPR: standard manual CPR
271883|NCT01325870|B2|Baseline|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
271884|NCT01325870|B1|Baseline|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
271885|NCT01325870|P3|Participant Flow|S-CPR|S-CPR: standard manual CPR
271886|NCT01325870|P2|Participant Flow|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
271887|NCT01325870|P1|Participant Flow|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
271888|NCT01325870|O3|Outcome|S-CPR|S-CPR: standard manual CPR
271889|NCT01325870|O2|Outcome|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
271890|NCT01325870|O1|Outcome|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
271891|NCT01325870|O3|Outcome|S-CPR|S-CPR: standard manual CPR
271892|NCT01325870|O2|Outcome|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
271893|NCT01325870|O1|Outcome|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
271894|NCT01325870|O3|Outcome|S-CPR|S-CPR: standard manual CPR
271895|NCT01325870|O2|Outcome|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
271896|NCT01325870|O1|Outcome|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
271897|NCT01325870|E3|Reported Event|S-CPR|S-CPR: standard manual CPR
271898|NCT01325870|E2|Reported Event|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
271899|NCT01325870|E1|Reported Event|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
271900|NCT01325792|B1|Baseline|Single-staged Open Complex Ventral Incisional Hernia Repair|"primary or recurrent anterior abdominal wall hernia~GORE BIO-A Tissue Reinforcement: Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure"
271901|NCT01325792|P1|Participant Flow|Single-staged Open Complex Ventral Incisional Hernia Repair|GORE® BIO-A® Tissue Reinforcement to reinforce the midline fascial closure in single-staged open complex ventral incisional (primary or recurrent anterior abdominal wall) hernia repair.
271902|NCT01325792|O1|Outcome|Single-staged Open Complex Ventral Incisional Hernia Repair|"primary or recurrent anterior abdominal wall hernia~GORE BIO-A Tissue Reinforcement: Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure"
271903|NCT01325792|O1|Outcome|Single-staged Open Complex Ventral Incisional Hernia Repair|"primary or recurrent anterior abdominal wall hernia~GORE BIO-A Tissue Reinforcement: Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure"
271904|NCT01325792|E1|Reported Event|GORE® BIO-A® Tissue Reinforcement|Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure after single-staged open complex ventral incisional hernia repair of primary or recurrent anterior abdominal wall hernia.
271905|NCT01325714|B3|Baseline|Total|Total of all reporting groups
271976|NCT01325623|O1|Outcome|Latency Analysis of Ictal Tachycardia Seizures|"The time difference between SDA detection of the ictal tachycardia seizure and the annotated seizure onset time.~Ictal Tachycardia Seizure is defined as a seizure with an increase from a baseline heart rate to a rate that is greater than 100 bpm and is at least a 55% increase or 35 bpm."
271906|NCT01325714|B2|Baseline|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
271907|NCT01325714|B1|Baseline|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
271908|NCT01325714|P2|Participant Flow|Arm 2: Enhanced Usual Care|107 caregivers were randomized to Enhanced Usual Care. Three were excluded at baseline because of aggression and two dropped out prior to baseline (one withdrew and one deceased). 102 caregivers were included in primary analysis. Dyads assigned to EU-PC received 8 weekly 15-minute phone calls to query symptom severity, ascertain needs for immediate psychiatric care, and provide minimal support. Primary care physicians of patients assigned to both groups received American Medical Association Continuing Medical Education print material on treating pain in older adults, as well as feedback progress notes documenting the PWD’s level of pain and depression at baseline, 3 months, 6 months, and 12 months
271909|NCT01325714|P1|Participant Flow|Arm 1: PAVeD Intervention|106 caregivers were randomized to the PAVeD intervention. Five were excluded at baseline because of aggression. 101 caregivers were included in the primary analysis. Dyads assigned to PAVeD received 6 to 8 weekly sessions of 45-minute home visits. PAVeD consists of 4 weekly 45- minute “core” sessions (“Recognizing Pain”; “Recognizing and Responding to Pain and Distress”; “Enhancing Communication”; “Making Daily Activities More Pleasant and Enjoyable”) and 2 of 4 elective sessions (“Medical Treatments and Talking to Your Doctor,” “Rest and Relaxation Strategies,” “Communication Problems and Challenges,” and “Increasing Pleasant Activities”), chosen with the patient and/or caregiver through collaborative goal setting during the first session. The intervention includes didactics, skill-building, discussion, and role-playing guided by a clinician manual and caregiver workbook.
271910|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
271911|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
271912|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
271913|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
271914|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
271915|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
271916|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
271977|NCT01325623|O1|Outcome|Beat Detection Sensitivity By Device IPG|"Cardiac R‐Wave Detection Sensitivity Based on Device IPG and ECG Monitor Comparison for 10 second Detection Window. n denotes the total number of patients with available R‐R wave data at the visit time point."
272180|NCT01324947|O1|Outcome|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
271917|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
271918|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
271919|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
271920|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
271921|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
271922|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
271923|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
271924|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
271925|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
271926|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain.~N = 102"
271927|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months. N = 101"
271928|NCT01325714|E2|Reported Event|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
271978|NCT01325623|O1|Outcome|Potential False Positives|Potential False Positives Based on Heart Rate Increase Associated with Seizures by Randomized SDA Setting (AutoStim Per Hour)
272248|NCT01324622|O2|Outcome|Laminoplasty|Treatment Group: Laminoplasty using ARCH Fixation System with allograft bone spacers
271929|NCT01325714|E1|Reported Event|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
271930|NCT01325701|B3|Baseline|Total|Total of all reporting groups
271931|NCT01325701|B2|Baseline|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
271932|NCT01325701|B1|Baseline|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
271933|NCT01325701|P2|Participant Flow|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
271934|NCT01325701|P1|Participant Flow|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
271935|NCT01325701|O2|Outcome|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
271936|NCT01325701|O1|Outcome|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis
271937|NCT01325701|O2|Outcome|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
271938|NCT01325701|O1|Outcome|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
271939|NCT01325701|O2|Outcome|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
271940|NCT01325701|O1|Outcome|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
271941|NCT01325701|E2|Reported Event|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
271942|NCT01325701|E1|Reported Event|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
271943|NCT01325623|B1|Baseline|VNS Therapy (Safety Population)|The safety population consists of all patients who provided consent and were implanted with the AspireSR VNS Therapy System version 1 or version 2.
271944|NCT01325623|P1|Participant Flow|Enrolled and Treated Population (Safety Population)|"Consists of all patients who provided consent and were implanted with the AspireSR VNS Therapy System version 1 or version 2. The safety population will be used for all safety analyses. (N=31 subjects).~In version 2 of the AspireSR VNS Therapy System, the TVS diodes (present in version 1) were removed from the electrical circuit to address the accumulation of electrical charge on the sensing node (e.g. generator-can) following delivery of a stimulation."
271945|NCT01325623|O1|Outcome|Percentage Change in Heart Rate|Average percentage change in heart rate from pre-stimulation period to heart rate during VNS Therapy Stimulation, following VNS Therapy Stimulation, and following the black-out period.
271946|NCT01325623|O4|Outcome|Unstimulated Seizures|Unstimulated seizures with =>20% increase in heart rate.
271947|NCT01325623|O3|Outcome|Terminated Seizures|Seizures which ended during Automatic Stimulation
271948|NCT01325623|O2|Outcome|All EMU Stimulated Seizures|Stimulated Seizures with >= 20% increase in heart rate
271949|NCT01325623|O1|Outcome|Historical Seizures|Pre-study EEG recordings
271950|NCT01325623|O5|Outcome|QOLIE-31-P Scores at 24 Months|QOLIE‐31‐P Scores at Follow-Up Visits
271951|NCT01325623|O4|Outcome|QOLIE-31-P Scores at 18 Months|QOLIE‐31‐P Scores at Follow-Up Visits
271952|NCT01325623|O3|Outcome|QOLIE-31-P Scores at 12 Months|QOLIE‐31‐P Scores at Follow-Up Visits
271953|NCT01325623|O2|Outcome|QOLIE-31-P Scores at 6 Months|QOLIE‐31‐P Scores at Follow-Up Visits
271954|NCT01325623|O1|Outcome|QOLIE-31-P Scores at 3 Months|QOLIE‐31‐P Scores at Follow-Up Visits
271955|NCT01325623|O3|Outcome|Unstimulated Seizures|Unstimulated seizures with >20% increase in heart rate.
271956|NCT01325623|O2|Outcome|Terminated Seizures|Seizures which ended during Automatic Stimulation
271957|NCT01325623|O1|Outcome|Historical Seizures|Pre-study EEG recordings
271958|NCT01325623|O3|Outcome|Unstimulated Seizures|Unstimulated seizures with >20% increase in heart rate.
271959|NCT01325623|O2|Outcome|Terminated Seizures|Seizures which ended during Automatic Stimulation
271960|NCT01325623|O1|Outcome|Historical Seizures|Pre-study EEG recordings
271961|NCT01325623|O1|Outcome|Proportion of Seizures Ending During Stimulation by Type|EMU seizures that were treated with Automatic Stimulation and ended during the course of the stimulation
271962|NCT01325623|O5|Outcome|SSQ Scores at 24 Months|Change From Baseline at Each Category
271963|NCT01325623|O4|Outcome|SSQ Scores at 18 Months|Change From Baseline at Each Category
271964|NCT01325623|O3|Outcome|SSQ Scores at 12 Months|Change From Baseline at Each Category
271965|NCT01325623|O2|Outcome|SSQ Scores at 6 Months|Change From Baseline at Each Category
271966|NCT01325623|O1|Outcome|SSQ Scores at 3 Months|Change From Baseline at Each Category
271967|NCT01325623|O4|Outcome|Generalized Tonic Clonic Sz|NHS3 Scores at Follow-Up Visits
271968|NCT01325623|O3|Outcome|CPS w/2nd GTC|NHS3 Scores at Follow-Up Visits
271969|NCT01325623|O2|Outcome|Complex Partial Seizures (CPS)|NHS3 Scores at Follow-Up Visits
271970|NCT01325623|O1|Outcome|Simple Partial Seizures|NHS3 Scores at Follow-Up Visits
271971|NCT01325623|O2|Outcome|Partial Seizures|"Summary of Responders (>= 50% Seizure Counts Reduction per Month) by Visit (Partial Seizures)~Partial seizures consist of simple partial, complex partial, complex partial with secondarily generalized seizures."
271972|NCT01325623|O1|Outcome|Overall Seizure Responder Rate|Summary of Responders (>= 50% Seizure Counts Reduction per Month) by Visit (All seizure types)
271973|NCT01325623|O2|Outcome|Day 5 EMU or EMU Discharge|Assessment of Device Usability at EMU (Day 5 or Discharge)
271974|NCT01325623|O1|Outcome|Implant/Recovery|Assessment of Device Usability at Implant and Recovery
271975|NCT01325623|O2|Outcome|Latency Analysis of All Seizure Types|The time difference between SDA seizure detection time and the annotated seizure onset time (ALL seizures).
292456|NCT01264770|O5|Outcome|Dosing Group E|PLACEBO (COMBINED)
271980|NCT01325623|O1|Outcome|% Sensitivity|Total number of seizures detected by M106 divided by the total number of seizures reported (investigator + confirmation by triple review) during the EMU stay
271981|NCT01325623|O3|Outcome|Total|Seizures from an ITT subject that were either identified by the investigator during EMU evaluation or during the triple review process of EEG data.
271982|NCT01325623|O2|Outcome|Reported by Triple Review|All seizures that occurred during EMU stay and that were identified by triple review post EMU.
271983|NCT01325623|O1|Outcome|Reported by Investigators|All seizures that occurred during EMU stay and that were identified by investigators.
271984|NCT01325623|E1|Reported Event|VNS Therapy - Safety Population|All adverse events were collected from baseline up to the 24-month follow-up visit for all subjects treated/implanted with the AspireSR® VNS Therapy® system. All SAEs are reported in the SAE data table, whereas only the most common AEs (> 5%) are reported in the AE data table.
271985|NCT01325532|B3|Baseline|Total|Total of all reporting groups
271986|NCT01325532|B2|Baseline|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device’s green and yellow amperage lights still light up, protecting the blind.~Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
271987|NCT01325532|B1|Baseline|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of “on” and 16.7msec of “off” time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the “on” time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and “off” time is followed by an opposite negative burst and “off” time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.~Active CES: CES current"
271988|NCT01325532|P2|Participant Flow|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device’s green and yellow amperage lights still light up, protecting the blind.~Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
271989|NCT01325532|P1|Participant Flow|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of “on” and 16.7msec of “off” time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the “on” time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and “off” time is followed by an opposite negative burst and “off” time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.~Active CES: CES current"
271990|NCT01325532|O2|Outcome|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device’s green and yellow amperage lights still light up, protecting the blind.~Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
271991|NCT01325532|O1|Outcome|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of “on” and 16.7msec of “off” time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the “on” time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and “off” time is followed by an opposite negative burst and “off” time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.~Active CES: CES current"
271992|NCT01325532|O2|Outcome|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device’s green and yellow amperage lights still light up, protecting the blind.~Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
271993|NCT01325532|O1|Outcome|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of “on” and 16.7msec of “off” time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the “on” time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and “off” time is followed by an opposite negative burst and “off” time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.~Active CES: CES current"
272032|NCT01325350|B2|Baseline|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
271994|NCT01325532|O2|Outcome|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device’s green and yellow amperage lights still light up, protecting the blind.~Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
271995|NCT01325532|O1|Outcome|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of “on” and 16.7msec of “off” time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the “on” time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and “off” time is followed by an opposite negative burst and “off” time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.~Active CES: CES current"
271996|NCT01325532|E2|Reported Event|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device’s green and yellow amperage lights still light up, protecting the blind.~Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
271997|NCT01325532|E1|Reported Event|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of “on” and 16.7msec of “off” time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the “on” time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and “off” time is followed by an opposite negative burst and “off” time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.~Active CES: CES current"
271998|NCT01325493|B3|Baseline|Total|Total of all reporting groups
271999|NCT01325493|B2|Baseline|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
272000|NCT01325493|B1|Baseline|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
272001|NCT01325493|P2|Participant Flow|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
272002|NCT01325493|P1|Participant Flow|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
272003|NCT01325493|O2|Outcome|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
272004|NCT01325493|O1|Outcome|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
272005|NCT01325493|O2|Outcome|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
272006|NCT01325493|O1|Outcome|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
272007|NCT01325493|O2|Outcome|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
272008|NCT01325493|O1|Outcome|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
272009|NCT01325493|O2|Outcome|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
272010|NCT01325493|O1|Outcome|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
272011|NCT01325493|E2|Reported Event|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
272012|NCT01325493|E1|Reported Event|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
272013|NCT01325428|B1|Baseline|Part A: Afatinib Once Daily. Part B: Afatinib+V (Vinorelbine).|"Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until Progression of their Disease (PD). In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.~Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent."
272014|NCT01325428|P1|Participant Flow|Afatinib (Part A). Afatinib+V (Vinorelbine) (Part B).|"Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until Progression of their Disease (PD). In case of treatment-related adverse events (AEs), the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.~Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent."
272015|NCT01325428|O1|Outcome|Afatinib Once Daily (OD). Afatinib+V (Vinorelbine).|"Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until PD. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.~Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval."
272016|NCT01325428|O1|Outcome|Part B: Afatinib Once Daily (OD)+V (Vinorelbine).|Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.
272017|NCT01325428|O1|Outcome|Part A: Afatinib Once Daily (OD).|Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
272018|NCT01325428|O1|Outcome|Part B: Afatinib Once Daily (OD)+V (Vinorelbine).|Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.
272019|NCT01325428|O1|Outcome|Part A: Afatinib Once Daily (OD).|Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
272020|NCT01325428|O1|Outcome|Part B: Afatinib Once Daily (OD)+V (Vinorelbine).|Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.
272021|NCT01325428|O1|Outcome|Part A: Afatinib Once Daily (OD).|Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily. The 95% Confidence Interval is Exact Confidence Interval.
272022|NCT01325428|O1|Outcome|Part B: Afatinib Once Daily (OD)+V (Vinorelbine).|Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.
272023|NCT01325428|O1|Outcome|Part A: Afatinib Once Daily (OD).|Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily. The 95% Confidence Interval is Exact Confidence Interval.
272024|NCT01325428|O1|Outcome|Part B: Afatinib Once Daily (OD)+V (Vinorelbine).|Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.
272025|NCT01325428|O1|Outcome|Part A: Afatinib Once Daily (OD).|"Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until PD. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.~The 95% Confidence Interval is Exact Confidence Interval."
272026|NCT01325428|E2|Reported Event|Part B: Afatinib+V (Vinorelbine).|Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent.
272027|NCT01325428|E1|Reported Event|Part A: Afatinib Once Daily (OD).|Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
272028|NCT01325350|B6|Baseline|Total|Total of all reporting groups
272029|NCT01325350|B5|Baseline|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
272030|NCT01325350|B4|Baseline|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
272031|NCT01325350|B3|Baseline|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
272033|NCT01325350|B1|Baseline|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
272034|NCT01325350|P5|Participant Flow|Minoxidil 2% Solution|Approximately one mL of minoxidil 2% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
272035|NCT01325350|P4|Participant Flow|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
272036|NCT01325350|P3|Participant Flow|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
272037|NCT01325350|P2|Participant Flow|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
272038|NCT01325350|P1|Participant Flow|Bimatoprost Formulation A|Approximately one milliliter (mL) of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
272039|NCT01325350|O5|Outcome|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
272040|NCT01325350|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
272041|NCT01325350|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
272042|NCT01325350|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
272043|NCT01325350|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
272044|NCT01325350|O5|Outcome|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
272045|NCT01325350|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
272046|NCT01325350|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
272047|NCT01325350|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
272048|NCT01325350|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
272049|NCT01325350|O5|Outcome|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
272050|NCT01325350|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
272051|NCT01325350|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
272052|NCT01325350|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
272053|NCT01325350|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
272054|NCT01325350|O5|Outcome|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
272055|NCT01325350|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
272056|NCT01325350|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
272057|NCT01325350|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
272058|NCT01325350|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
272059|NCT01325350|O5|Outcome|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
272060|NCT01325350|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
272061|NCT01325350|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
272062|NCT01325350|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
272063|NCT01325350|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
272064|NCT01325350|O5|Outcome|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
272065|NCT01325350|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
272066|NCT01325350|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
272067|NCT01325350|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
272068|NCT01325350|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
272069|NCT01325350|E5|Reported Event|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
272070|NCT01325350|E4|Reported Event|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
272071|NCT01325350|E3|Reported Event|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
292457|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
272072|NCT01325350|E2|Reported Event|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
272073|NCT01325350|E1|Reported Event|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
272074|NCT01325337|B6|Baseline|Total|Total of all reporting groups
272075|NCT01325337|B5|Baseline|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
272076|NCT01325337|B4|Baseline|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
272077|NCT01325337|B3|Baseline|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
272078|NCT01325337|B2|Baseline|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
272079|NCT01325337|B1|Baseline|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
272080|NCT01325337|P5|Participant Flow|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
272081|NCT01325337|P4|Participant Flow|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
272082|NCT01325337|P3|Participant Flow|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
272083|NCT01325337|P2|Participant Flow|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
272084|NCT01325337|P1|Participant Flow|Bimatoprost Formulation A|Approximately one milliliter (mL) of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
272085|NCT01325337|O5|Outcome|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
272086|NCT01325337|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
272087|NCT01325337|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
272088|NCT01325337|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
272089|NCT01325337|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
272090|NCT01325337|O5|Outcome|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
272091|NCT01325337|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
272092|NCT01325337|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
272093|NCT01325337|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
272094|NCT01325337|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
272095|NCT01325337|O5|Outcome|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
272096|NCT01325337|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
272097|NCT01325337|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
272098|NCT01325337|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
272099|NCT01325337|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
272100|NCT01325337|O5|Outcome|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
272101|NCT01325337|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
272102|NCT01325337|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
272103|NCT01325337|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
272104|NCT01325337|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
272105|NCT01325337|O5|Outcome|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
272106|NCT01325337|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
272107|NCT01325337|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
272108|NCT01325337|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
272109|NCT01325337|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
272110|NCT01325337|O5|Outcome|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
272111|NCT01325337|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
272112|NCT01325337|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
272113|NCT01325337|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
272114|NCT01325337|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
272115|NCT01325337|E5|Reported Event|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
272116|NCT01325337|E4|Reported Event|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
272117|NCT01325337|E3|Reported Event|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
272118|NCT01325337|E2|Reported Event|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
272119|NCT01325337|E1|Reported Event|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
272120|NCT01325311|B3|Baseline|Total|Total of all reporting groups
272121|NCT01325311|B2|Baseline|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
272122|NCT01325311|B1|Baseline|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
272123|NCT01325311|P2|Participant Flow|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
272124|NCT01325311|P1|Participant Flow|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
272125|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
272126|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
272127|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
272128|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
272129|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
272130|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
272131|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
272132|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
272133|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
272134|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
272135|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
272136|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
272137|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
272138|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
298302|NCT01251757|B4|Baseline|Total|Total of all reporting groups
272139|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
272140|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
272141|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
272142|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
272143|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
272144|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
272145|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
272146|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
272147|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
272148|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
272149|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
272150|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
272151|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
272152|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
272153|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
272154|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
272155|NCT01325311|E2|Reported Event|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
272156|NCT01325311|E1|Reported Event|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
272157|NCT01325181|B3|Baseline|Total|Total of all reporting groups
272158|NCT01325181|B2|Baseline|Ranibizumab|
272159|NCT01325181|B1|Baseline|Low-fluence PDT|
272160|NCT01325181|P2|Participant Flow|Ranibizumab|
272161|NCT01325181|P1|Participant Flow|Low-fluence PDT|
272162|NCT01325181|O2|Outcome|Ranibizumab|
272163|NCT01325181|O1|Outcome|Low-fluence PDT|
272164|NCT01325181|E2|Reported Event|Ranibizumab|
272165|NCT01325181|E1|Reported Event|Low-fluence PDT|
272166|NCT01324999|B1|Baseline|Tadalafil|40 mg daily
272167|NCT01324999|P1|Participant Flow|Tadalafil|40 mg daily
272168|NCT01324999|O1|Outcome|Tadalafil|40 mg daily
272169|NCT01324999|O1|Outcome|Tadalafil|40 mg daily
272170|NCT01324999|O1|Outcome|Tadalafil|40 mg daily
272171|NCT01324999|O1|Outcome|Tadalafil|40 mg daily
272172|NCT01324999|O1|Outcome|Tadalafil|40 mg daily
272173|NCT01324999|O1|Outcome|Tadalafil|40 mg daily
272174|NCT01324999|O1|Outcome|Tadalafil|40 mg daily
272175|NCT01324999|O1|Outcome|Tadalafil|40 mg daily
272176|NCT01324999|E1|Reported Event|Tadalafil|40 mg daily
272177|NCT01324947|B1|Baseline|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
272178|NCT01324947|P1|Participant Flow|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
272181|NCT01324947|O1|Outcome|Pomalidomide|"Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity~pomalidomide: Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity"
272182|NCT01324947|O1|Outcome|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
272183|NCT01324947|O1|Outcome|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
272184|NCT01324947|O1|Outcome|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
272185|NCT01324947|O1|Outcome|Pomalidomide|"Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity~pomalidomide: Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity"
272186|NCT01324947|O1|Outcome|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
272187|NCT01324947|E1|Reported Event|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
272188|NCT01324882|B3|Baseline|Total|Total of all reporting groups
272189|NCT01324882|B2|Baseline|Control|This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
272190|NCT01324882|B1|Baseline|Study Arm|This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
272191|NCT01324882|P2|Participant Flow|Control|This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
272192|NCT01324882|P1|Participant Flow|Study Arm|This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
272193|NCT01324882|O2|Outcome|Control|"This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.~Control with standard colonoscope Olympus CF-H180: Standard colonoscopy using the adult scope, Olympus CF-H180."
272194|NCT01324882|O1|Outcome|Study Arm|"This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.~Colonoscopy with Olympus Technically Improved Colonoscope: The standard colonoscopy will be performed using the Olympus Technically Improved Colonoscope."
272195|NCT01324882|O2|Outcome|Control|This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
272196|NCT01324882|O1|Outcome|Study Arm|This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
272197|NCT01324882|E2|Reported Event|Control|This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
272198|NCT01324882|E1|Reported Event|Study Arm|This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
272199|NCT01324700|B5|Baseline|Total|Total of all reporting groups
272200|NCT01324700|B4|Baseline|Low Severity: Placebo|"Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). Participants in the low severity-placebo group had at least 3 steroid bursts in the past 12 months OR Hamilton Rating Scale for Depression (HRSD) score of at least 20. Participants received oral placebo (identical in appearance to the active medication) every 2 weeks for 12 total weeks."
272201|NCT01324700|B3|Baseline|Low Severity: Escitalopram|"Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). Participants in the low severity-escitalopram group had at least 3 steroid bursts in the past 12 months OR Hamilton Rating Scale for Depression (HRSD) score of at least 20. Participants received oral escitalopram at the dose of 10 mg/day with follow-up visits every 2 weeks for 12 total weeks. Participants who had not shown a decrease in HRSD score of at least 30% by week 4, had their dosage of escitalopram increased to 20 mg/day."
272202|NCT01324700|B2|Baseline|High Severity: Placebo|"Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). Participants in the high severity-placebo group had at least 3 steroid bursts in the past 12 months AND Hamilton Rating Scale for Depression (HRSD) score of at least 20. Participants received oral placebo (identical in appearance to the active medication) every 2 weeks for 12 total weeks."
272203|NCT01324700|B1|Baseline|High Severity: Escitalopram|"Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). Participants in the high severity-escitalopram group had at least 3 steroid bursts in the past 12 months AND Hamilton Rating Scale for Depression (HRSD) score of at least 20. Participants received oral escitalopram at the dose of 10 mg/day with follow-up visits every 2 weeks for 12 total weeks. Participants who had not shown a decrease in HRSD score of at least 30% by week 4, had their dosage of escitalopram increased to 20 mg/day."
272204|NCT01324700|P4|Participant Flow|Low Severity: Placebo|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). To be assigned to the low severity group, participants had to have fewer than 3 steroid bursts in the past 12 months OR Hamilton Rating Scale for Depression (HRSD) score of less than 20. Participants received placebo (identical in appearance to the active medication) with follow-up visits every 2 weeks for 12 total weeks.
272205|NCT01324700|P3|Participant Flow|Low Severity: Escitalopram|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). To be assigned to the low severity group, participants had to have fewer than 3 steroid bursts in the past 12 months OR Hamilton Rating Scale for Depression (HRSD) score of less than 20 (or both). Participants received escitalopram (or identical placebo) at the dose of 10 mg/day with follow-up visits every 2 weeks for 12 total weeks. Participants who had not shown a decrease in HRSD score of at least 30% by week 4, had their dosage of escitalopram increased to 20 mg/day (or equivalent placebo).
272206|NCT01324700|P2|Participant Flow|High Severity: Placebo|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). To be assigned to the high severity group, participants had to have at least 3 steroid bursts in the past 12 months AND Hamilton Rating Scale for Depression (HRSD) score of at least 20. Participants received placebo (identical in appearance to the active medication) with follow-up visits every 2 weeks for 12 total weeks.
272207|NCT01324700|P1|Participant Flow|High Severity: Escitalopram|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). To be assigned to the high severity group, participants had to have at least 3 steroid bursts in the past 12 months AND Hamilton Rating Scale for Depression (HRSD) score of at least 20. Participants received escitalopram (or identical placebo) at the dose of 10 mg/day with follow-up visits every 2 weeks for 12 total weeks. Participants who had not shown a decrease in HRSD score of at least 30% by week 4, had their dosage of escitalopram increased to 20 mg/day (or equivalent placebo).
272208|NCT01324700|O4|Outcome|Low Severity: Placebo|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
272209|NCT01324700|O3|Outcome|Low Severity: Escitalopram|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
272210|NCT01324700|O2|Outcome|High Severity: Placebo|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
272211|NCT01324700|O1|Outcome|High Severity: Escitalopram|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
272212|NCT01324700|O4|Outcome|Low Severity: Placebo|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
272213|NCT01324700|O3|Outcome|Low Severity: Escitalopram|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
272214|NCT01324700|O2|Outcome|High Severity: Placebo|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
272215|NCT01324700|O1|Outcome|High Severity: Escitalopram|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
272216|NCT01324700|E4|Reported Event|Low Severity: Placebo|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
272217|NCT01324700|E3|Reported Event|Low Severity: Escitalopram|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
272218|NCT01324700|E2|Reported Event|High Severity: Placebo|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
272219|NCT01324700|E1|Reported Event|High Severity: Escitalopram|Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
272220|NCT01324687|B3|Baseline|Total|Total of all reporting groups
272221|NCT01324687|B2|Baseline|Telemedicine Care|"Cohort with access to telemedicine in the home for acute care issues.~Telemedicine care: Availability of telemedicine"
272222|NCT01324687|B1|Baseline|Control|Group without access to telemedicine in the home for acute care issues.
272223|NCT01324687|P2|Participant Flow|Telemedicine Care|"Cohort with access to telemedicine in the home for acute care issues.~Telemedicine care: Availability of telemedicine"
272224|NCT01324687|P1|Participant Flow|Control|Group without access to telemedicine in the home for acute care issues.
272225|NCT01324687|O2|Outcome|Telemedicine Care|"Cohort with access to telemedicine in the home for acute care issues.~Telemedicine care: Availability of telemedicine"
272226|NCT01324687|O1|Outcome|Control|Group without access to telemedicine in the home for acute care issues.
272227|NCT01324687|O2|Outcome|Telemedicine Care|"Cohort with access to telemedicine in the home for acute care issues.~Telemedicine care: Availability of telemedicine"
272228|NCT01324687|O1|Outcome|Control|Group without access to telemedicine in the home for acute care issues.
272229|NCT01324687|E2|Reported Event|Telemedicine Care|"Cohort with access to telemedicine in the home for acute care issues.~Telemedicine care: Availability of telemedicine"
272230|NCT01324687|E1|Reported Event|Control|Group without access to telemedicine in the home for acute care issues.
272231|NCT01324622|B3|Baseline|Total|Total of all reporting groups
272232|NCT01324622|B2|Baseline|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
272233|NCT01324622|B1|Baseline|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
272234|NCT01324622|P2|Participant Flow|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
272235|NCT01324622|P1|Participant Flow|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
272236|NCT01324622|O2|Outcome|Laminoplasty|Treatment Group: Laminoplasty using ARCH Fixation System with allograft bone spacers
272237|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
272238|NCT01324622|O2|Outcome|Laminoplasty|Treatment Group: Laminoplasty using ARCH Fixation System with allograft bone spacers
272239|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
272240|NCT01324622|O2|Outcome|Laminoplasty|Treatment Group: Laminoplasty using ARCH Fixation System with allograft bone spacers
272241|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
272242|NCT01324622|O2|Outcome|Laminoplasty|Treatment Group: Laminoplasty using ARCH Fixation System with allograft bone spacers
272243|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
272244|NCT01324622|O2|Outcome|Laminoplasty|Treatment Group: Laminoplasty using ARCH Fixation System with allograft bone spacers
272245|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
272246|NCT01324622|O2|Outcome|Laminoplasty|Treatment Group: Laminoplasty using ARCH Fixation System with allograft bone spacers
272247|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
272250|NCT01324622|O2|Outcome|Laminoplasty|Treatment Group: Laminoplasty using ARCH Fixation System with allograft bone spacers
272251|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
272252|NCT01324622|O2|Outcome|Laminoplasty|Treatment Group: Laminoplasty using ARCH Fixation System with allograft bone spacers
272253|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
272254|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
272255|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
272256|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
272257|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
272258|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
272259|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
272260|NCT01324622|E2|Reported Event|Laminoplasty|Treatment group Laminoplasty: Utilizing the ARCH Fixation System (Study device)
272261|NCT01324622|E1|Reported Event|Laminectomy|Control laminectomy: standard procedure
272262|NCT01324570|B3|Baseline|Total|Total of all reporting groups
272263|NCT01324570|B2|Baseline|12 to 16 Years|Children 12 to 16 years of age
272264|NCT01324570|B1|Baseline|7 to 11 Years|Children 7 to 11 years of age
272265|NCT01324570|P2|Participant Flow|12 to 16 Years|Children 12 to 16 years of age
272266|NCT01324570|P1|Participant Flow|7 to 11 Years|Children 7 to 11 years of age
272267|NCT01324570|O1|Outcome|Population PK Analysis Set|Children 7 to 16 years of age (reference patient with IBW of 70 kg)
272268|NCT01324570|O2|Outcome|12 to 16 Years|Children 12 to 16 years of age
272269|NCT01324570|O1|Outcome|7 to 11 Years|Children 7 to 11 years of age
272270|NCT01324570|O1|Outcome|12 to 16 Years|Children 12 to 16 years of age
272271|NCT01324570|O1|Outcome|7 to 11 Years|Children 7 to 11 years of age
272272|NCT01324570|O1|Outcome|Population PK Analysis Set|Children 7 to 16 years of age (reference patient with IBW of 70 kg)
272273|NCT01324570|O2|Outcome|12 to 16 Years|Children 12 to 16 years of age
272274|NCT01324570|O1|Outcome|7 to 11 Years|Children 7 to 11 years of age
272275|NCT01324570|E2|Reported Event|12 to 16 Years|Children 12 to 16 years of age
272276|NCT01324570|E1|Reported Event|7 to 11 Years|Children 7 to 11 years of age
272277|NCT01324453|B3|Baseline|Total|Total of all reporting groups
272278|NCT01324453|B2|Baseline|Standard PCI|Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
272279|NCT01324453|B1|Baseline|Post Conditioning + PCI|Post Conditioning + Primary PCI: Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
272280|NCT01324453|P2|Participant Flow|Standard Percutaneous Coronary Internvention (PCI)|Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
272281|NCT01324453|P1|Participant Flow|Post Conditioning + Percutaneous Coronary Intervertion (PCI)|Post Conditioning + Primary PCI: Four, 30-second percutaneous transluminal coronary angioplasty (PTCA) balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to PCI as clinically indicated.
272282|NCT01324453|O2|Outcome|Standard PCI|Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
272283|NCT01324453|O1|Outcome|Post Conditioning + PCI|Post Conditioning + Primary PCI: Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
272284|NCT01324453|O2|Outcome|Standard PCI|Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
272285|NCT01324453|O1|Outcome|Post Conditioning + PCI|Post Conditioning + Primary PCI: Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
272286|NCT01324453|O2|Outcome|Standard PCI|Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
272287|NCT01324453|O1|Outcome|Post Conditioning + PCI|Post Conditioning + Primary PCI: Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
272288|NCT01324453|O2|Outcome|Standard PCI|Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
272289|NCT01324453|O1|Outcome|Post Conditioning + PCI|Post Conditioning + Primary PCI: Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
272290|NCT01324453|O2|Outcome|Standard PCI|Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
272291|NCT01324453|O1|Outcome|Post Conditioning + PCI|Post Conditioning + Primary PCI: Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
272292|NCT01324453|O2|Outcome|Standard PCI|Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
272293|NCT01324453|O1|Outcome|Post Conditioning + PCI|Post Conditioning + Primary PCI: Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
272294|NCT01324453|O2|Outcome|Standard PCI|Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
272295|NCT01324453|O1|Outcome|Post Conditioning + PCI|Post Conditioning + Primary PCI: Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
272296|NCT01324453|O2|Outcome|Standard PCI|Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
272385|NCT01324310|P1|Participant Flow|Romidepsin and Ketoconazole|"Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8~Ketoconazole 400 mg oral once daily on Days 4-8"
272297|NCT01324453|O1|Outcome|Post Conditioning + PCI|Post Conditioning + Primary PCI: Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
272298|NCT01324453|E2|Reported Event|Standard PCI|Standard Primary PCI: Routine Percutaneous Coronary Intervention as clinically indicated.
272299|NCT01324453|E1|Reported Event|Post Conditioning + PCI|Post Conditioning + Primary PCI: Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
272300|NCT01324440|B3|Baseline|Total|Total of all reporting groups
272301|NCT01324440|B2|Baseline|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
272302|NCT01324440|B1|Baseline|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
272303|NCT01324440|P2|Participant Flow|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
272304|NCT01324440|P1|Participant Flow|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
272305|NCT01324440|O2|Outcome|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
272306|NCT01324440|O1|Outcome|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
272307|NCT01324440|O2|Outcome|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
272308|NCT01324440|O1|Outcome|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
272309|NCT01324440|O2|Outcome|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
272310|NCT01324440|O1|Outcome|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
272311|NCT01324440|O2|Outcome|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
272312|NCT01324440|O1|Outcome|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
272313|NCT01324440|E2|Reported Event|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
272314|NCT01324440|E1|Reported Event|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
272315|NCT01324401|B3|Baseline|Total|Total of all reporting groups
272316|NCT01324401|B2|Baseline|Peanut OIT|Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
272317|NCT01324401|B1|Baseline|Control - Crossover|The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will have the opportunity to cross over to active therapy.
272318|NCT01324401|P2|Participant Flow|Peanut OIT|Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
272319|NCT01324401|P1|Participant Flow|Control - Crossover|The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
272320|NCT01324401|O2|Outcome|Peanut OIT|Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
272321|NCT01324401|O1|Outcome|Control - Crossover|The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
272322|NCT01324401|O2|Outcome|Peanut OIT|Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
272323|NCT01324401|O1|Outcome|Control - Crossover|The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
272324|NCT01324401|E2|Reported Event|Peanut OIT|Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
272325|NCT01324401|E1|Reported Event|Control - Crossover|The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
272326|NCT01324388|B4|Baseline|Total|Total of all reporting groups
272327|NCT01324388|B3|Baseline|Part 2: LY2189265 + Metoprolol Crossover|"Participants received 2 treatments in Part 2 of the study:~Treatment 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1~Treatment 2: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5; Metoprolol: 100 mg, oral, on Days 1 through 7~Participants were randomized to 1 of 2 treatment sequences in Part 2 of the study:~Treatment Sequence A: Treatment 1, Treatment 2~Treatment Sequence B: Treatment 2, Treatment 1~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 to Day 1 for Treatment Sequence A and Day 7 to Day 1 for Treatment Sequence B)."
272328|NCT01324388|B2|Baseline|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
272329|NCT01324388|B1|Baseline|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
272330|NCT01324388|P4|Participant Flow|Part 2: LY2189265 + Metoprolol First, Then LY2189265|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5 of Treatment 2 and on Day 1 of Treatment 1 in Part 2 of the study.~Metoprolol: 100 mg, oral, on Days 1 through 7 of Treatment 1 in Part 2 of the study.~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 7 of Treatment 2 to Day 1 of Treatment 1 in Part 2 of the study)."
272331|NCT01324388|P3|Participant Flow|Part 2: LY2189265 First, Then LY2189265 + Metoprolol|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1 of Treatment 1 and on Day 5 of Treatment 2 in Part 2 of the study.~Metoprolol: 100 mg, oral, on Days 1 through 7 of Treatment 2 in Part 2 of the study.~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 of Treatment 1 to Day 1 of Treatment 2 in Part 2 of the study)."
272332|NCT01324388|P2|Participant Flow|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
272333|NCT01324388|P1|Participant Flow|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
272334|NCT01324388|O1|Outcome|Part 2: LY2189265 + Metoprolol (Treatment 2)|"Participants received 2 treatments in Part 2 of the study:~Treatment 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1~Treatment 2: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5 ; Metoprolol: 100 mg, oral, on Days 1 through 7~Participants were randomized to 1 of 2 treatment sequences in Part 2 of the study:~Treatment Sequence A: Treatment 1, Treatment 2~Treatment Sequence B: Treatment 2, Treatment 1~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 to Day 1 for Treatment Sequence A and Day 7 to Day 1 for Treatment Sequence B)."
272335|NCT01324388|O1|Outcome|Part 2: LY2189265 + Metoprolol (Treatment 2)|"Participants received 2 treatments in Part 2 of the study:~Treatment 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1~Treatment 2: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5; Metoprolol: 100 mg, oral, on Days 1 through 7~Participants were randomized to 1 of 2 treatment sequences in Part 2 of the study:~Treatment Sequence A: Treatment 1, Treatment 2~Treatment Sequence B: Treatment 2, Treatment 1~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 to Day 1 for Treatment Sequence A and Day 7 to Day 1 for Treatment Sequence B)."
272336|NCT01324388|O2|Outcome|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
272337|NCT01324388|O1|Outcome|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
272338|NCT01324388|O1|Outcome|Part 2: LY2189265 + Metoprolol Crossover|"Participants received 2 treatments in Part 2 of the study:~Treatment 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1~Treatment 2: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5; Metoprolol: 100 mg, oral, on Days 1 through 7~Participants were randomized to 1 of 2 treatment sequences in Part 2 of the study:~Treatment Sequence A: Treatment 1, Treatment 2~Treatment Sequence B: Treatment 2, Treatment 1~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 to Day 1 for Treatment Sequence A and Day 7 to Day 1 for Treatment Sequence B)."
272339|NCT01324388|O1|Outcome|Part 2: LY2189265 + Metoprolol Crossover|"Participants received 2 treatments in Part 2 of the study:~Treatment 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1~Treatment 2: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5; Metoprolol: 100 mg, oral, on Days 1 through 7~Participants were randomized to 1 of 2 treatment sequences in Part 2 of the study:~Treatment Sequence A: Treatment 1, Treatment 2~Treatment Sequence B: Treatment 2, Treatment 1~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 to Day 1 for Treatment Sequence A and Day 7 to Day 1 for Treatment Sequence B)."
272340|NCT01324388|O2|Outcome|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
272341|NCT01324388|O1|Outcome|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
272342|NCT01324388|O2|Outcome|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
272386|NCT01324310|O1|Outcome|Romidepsin Plus Ketoconazole|Romidepsin 8 mg/m2 intravenous infused over 4 hours on Day 1 and Day 8. Ketoconazole 400 mg oral once daily on Days 4-8
272343|NCT01324388|O1|Outcome|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
272344|NCT01324388|O2|Outcome|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
272345|NCT01324388|O1|Outcome|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
272346|NCT01324388|E5|Reported Event|Part 2: LY2189265 + Metoprolol|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5 of Treatment 2 in Part 2 of the study.~Metoprolol: 100 mg, oral, on Days 5 through 7 of Treatment 2 in Part 2 of the study.~Time frame: Day 5 to end of Treatment 2"
272347|NCT01324388|E4|Reported Event|Part 2: Metoprolol|"Metoprolol: 100 milligrams (mg), oral, on Days 1 through 4 of Treatment 2 in Part 2 of the study.~Time frame: Days 1 to 4 of Treatment 2"
272348|NCT01324388|E3|Reported Event|Part 2: LY2189265|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1 of Treatment 1 in Part 2 of the study.~Time frame: Treatment 1"
272349|NCT01324388|E2|Reported Event|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
272350|NCT01324388|E1|Reported Event|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
272351|NCT01324349|B3|Baseline|Total|Total of all reporting groups
272352|NCT01324349|B2|Baseline|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®
272353|NCT01324349|B1|Baseline|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
272354|NCT01324349|P2|Participant Flow|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®
272355|NCT01324349|P1|Participant Flow|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
272356|NCT01324349|O2|Outcome|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®.
272357|NCT01324349|O1|Outcome|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
272358|NCT01324349|O2|Outcome|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®.
272359|NCT01324349|O1|Outcome|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
272360|NCT01324349|O2|Outcome|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®.
272361|NCT01324349|O1|Outcome|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
272362|NCT01324349|E2|Reported Event|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®.
272363|NCT01324349|E1|Reported Event|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
272364|NCT01324323|B1|Baseline|Romidepsin and Rifampin|"Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8.~Rifampin 600 mg oral once daily on Days 4-8"
272365|NCT01324323|P1|Participant Flow|Romidepsin and Rifampin|"Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8.~Rifampin 600 mg oral once daily on Days 4-8"
272366|NCT01324323|O1|Outcome|Romidepsin Plus Rifampin|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Days 1 and 8. Rifampin 600 mg oral once daily on Days 4-8
272367|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600 mg oral once daily on Days 4-8
272368|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1.
272369|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600 mg oral once daily on Days 4-8
272370|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1.
272371|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600 mg oral once daily on Days 4-8
272372|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1.
272373|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600 mg oral once daily on Days 4-8
272374|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1.
272375|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600mg oral once daily on Days 4-8
272376|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1.
272377|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600 mg oral once daily on Days 4-8.
272378|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1
272379|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600 mg oral once daily on Days 4-8
272380|NCT01324323|O1|Outcome|Romidepsin Day 1|"Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1.~Rifampin 600 mg oral once daily on Days 4-8"
272381|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600mg oral once daily on Days 4-8.
272382|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8.
272383|NCT01324323|E1|Reported Event|Romidepsin Plus Rifampin|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8 and Rifampin 600 mg oral once daily on Days 4-8.
272384|NCT01324310|B1|Baseline|Romidepsin and Ketoconazole|"Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8.~Ketoconazole 400 mg oral once daily on Days 4-8"
272387|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
272388|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
272389|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
272390|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
272391|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
272392|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
272393|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
272394|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
272395|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
272396|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
272397|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
272398|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
272399|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
272400|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
272401|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
272402|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
272403|NCT01324310|E1|Reported Event|Romidepsin Plus Ketoconazole|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8. Ketoconazole 400 mg oral once daily on Days 4-8
272404|NCT01324271|B1|Baseline|Tympanostomy Tube Placement|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting.
272405|NCT01324271|P2|Participant Flow|Tympanostomy Tube Placement (Study Cohort)|Acclarent Tympanostomy Tube Delivery system (TTDS): Placement of tympanostomy tube under local anesthesia in office/clinic setting
272406|NCT01324271|P1|Participant Flow|Tympanostomy Tube Placement (Lead-In Procedures)|"Acclarent Tympanostomy Tube Delivery system (TTDS):~Placement of tympanostomy tube under local anesthesia in office/clinic setting or under general anesthesia in operating room."
272407|NCT01324271|O1|Outcome|Tympanostomy Tube Placement|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting
272408|NCT01324271|O1|Outcome|Tube Placement Using the TTDS in Office/Clinic Setting|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting
272409|NCT01324271|O1|Outcome|Tympanostomy Tube Placement|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting.
272410|NCT01324271|E1|Reported Event|Tympanostomy Tube Placement|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS).
272411|NCT01324128|B3|Baseline|Total|Total of all reporting groups
272412|NCT01324128|B2|Baseline|Sevelamer Carbonate Stage 1|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
272413|NCT01324128|B1|Baseline|PA21 Stage 1|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
272414|NCT01324128|P4|Participant Flow|PA21-1 (LD) Stage 2|PA21-1 (1.25 g/day) Low Dose (LD) comparator for Stage 2.
272415|NCT01324128|P3|Participant Flow|PA21 (MD) Stage 2|PA21 Maintenance Dose (MD). Continuation of same dose that was being received at the end of Stage 1
272416|NCT01324128|P2|Participant Flow|Sevelamer Carbonate Stage 1|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
272417|NCT01324128|P1|Participant Flow|PA21 Stage 1|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
272418|NCT01324128|O2|Outcome|Sevelamer Carbonate Stage 1|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
272419|NCT01324128|O1|Outcome|PA21 (2.5 g Tablet) Stage 1|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
272420|NCT01324128|O2|Outcome|PA21-1 (LD) Stage 2|PA21-1 Low Dose (LD) comparator (1.25 g/day) for Stage 2
272421|NCT01324128|O1|Outcome|PA21 (MD) Stage 2|PA21 Stage 2 Maintenance Dose (MD). Continuation of same dose that was being received at the end of Stage 1.
272422|NCT01324128|E4|Reported Event|PA21 (MD) Stage 2|PA21 (2.5g tablet) Maintenance Dose (MD). Continuation of same dose that was being received at the end of Stage 1.
272423|NCT01324128|E3|Reported Event|PA21-1 (LD) Stage 2|PA21-1 (1.25 g tablet). Low Dose (LD) comparator (1.25 g/day) for Stage 2.
272424|NCT01324128|E2|Reported Event|Sevelamer Carbonate Stage 1|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
272425|NCT01324128|E1|Reported Event|PA21 Stage 1|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
272426|NCT01324102|B3|Baseline|Total|Total of all reporting groups
272427|NCT01324102|B2|Baseline|Wait List Control|Wait List control: The wait list control did not receive an intervention.
272428|NCT01324102|B1|Baseline|Yoga Therapy Intervention|Intervention: Yoga therapy was 8 week class for two times per week
272429|NCT01324102|P2|Participant Flow|Wait List Control|Wait List control received no intervention for 8 weeks, then joined the yoga group
272430|NCT01324102|P1|Participant Flow|Yoga Therapy Intervention|"Intervention~Yoga therapy received an 8 week 2x weekly Yoga therapy class."
272431|NCT01324102|O2|Outcome|Post Group Values|Patient Reported Outcome Measurement System values for all participants after participation in 8 session Yoga Therapy with home practice
272432|NCT01324102|O1|Outcome|Pre Group Values|Patient Reported Outcome Measurement System values for all participants prior to participation in 8 session Yoga Therapy with home practice
272433|NCT01324102|E3|Reported Event|Wait List on Yoga Therapy|"Received yoga therapy after an 8 week wait.~No participants were hospitalized."
272434|NCT01324102|E2|Reported Event|Wait List|"Received no yoga therapy for 8 weeks while the intervention group received yoga therapy~One participant in the Arm 2, Wait list, age 65, was hospitalized. His principal diagnosis was pneumonia."
272435|NCT01324102|E1|Reported Event|Yoga Therapy|"Received yoga therapy.~One participant in the Arm 1, Yoga therapy, age 80, was hospitalized. His principal diagnosis was influenza."
272436|NCT01324024|B1|Baseline|All Study Participants|Participants were randomized to receive either Lisdexampethamine in titrated doses (20mg/d- 60mg/d) or Placebo tablets (matching Lisdexamphetamine).
272437|NCT01324024|P2|Participant Flow|Placebo First, Then Lisdexamfetamine|Participants first received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks, followed by a 2-week washout, then they received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks (i.e, 20mg/d for 1 week, 40mg/d for 1 week and 60mg/d for 2 weeks).
272438|NCT01324024|P1|Participant Flow|Lisdexamfetamine, Then Placebo|Participants first received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks (i.e, 20mg/d for 1 week, 40mg/d for 1 week and 60mg/d for 2 weeks) followed by a 2-week washout, then they received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.
272439|NCT01324024|O3|Outcome|Placebo|Participants received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.
272440|NCT01324024|O2|Outcome|Lisdexamfetamine|Participants received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks (i.e, 20mg/d for 1 week, 40mg/d for 1 week and 60mg/d for 2 weeks).
272441|NCT01324024|O1|Outcome|Baseline|
272442|NCT01324024|O3|Outcome|Sugar Pill|"Placebo pill, capsules~Lisdexamfetamine: The purpose of this study is to assess whether or not lisdexamfetamine is effective in alleviating cognitive disruptions when compared to a placebo."
272443|NCT01324024|O2|Outcome|Lisdexamfetamine|"Lisdexamfetamine or Vyvanse~Lisdexamfetamine: The purpose of this study is to assess whether or not lisdexamfetamine is effective in alleviating cognitive disruptions when compared to a placebo."
272444|NCT01324024|O1|Outcome|Baseline|
272445|NCT01324024|O3|Outcome|Sugar Pill|"Placebo pill, capsules~Lisdexamfetamine: The purpose of this study is to assess whether or not lisdexamfetamine is effective in alleviating cognitive disruptions when compared to a placebo."
272446|NCT01324024|O2|Outcome|Lisdexamfetamine|Participants who received Lisdexamfetamine 20
272447|NCT01324024|O1|Outcome|Baseline|
272448|NCT01324024|E2|Reported Event|Sugar Pill|"Placebo pill, capsules~Lisdexamfetamine: The purpose of this study is to assess whether or not lisdexamfetamine is effective in alleviating cognitive disruptions when compared to a placebo."
272449|NCT01324024|E1|Reported Event|Lisdexamfetamine|"Lisdexamfetamine or Vyvanse~Lisdexamfetamine: The purpose of this study is to assess whether or not lisdexamfetamine is effective in alleviating cognitive disruptions when compared to a placebo."
272450|NCT01323998|B6|Baseline|Total|Total of all reporting groups
272451|NCT01323998|B5|Baseline|5ARI Plus AB Combination Therapy|Males aged 50 and older who had a new pharmacy claim for 5ARI and a subsequent claim for AB within one year of the initial 5ARI claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
272452|NCT01323998|B4|Baseline|AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI between 30 days and one year of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
272453|NCT01323998|B3|Baseline|AB Plus 5ARI Combination Therapy, Early 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI within 30 days of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
272454|NCT01323998|B2|Baseline|5 Alpha Reductase Inhibitor (5ARI) Monotherapy|Males aged 50 and older who had a new pharmacy claim for 5ARI monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
272455|NCT01323998|B1|Baseline|Alpha-blocker (AB) Monotherapy|Males aged 50 and older who had a new pharmacy claim for AB monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
272456|NCT01323998|P5|Participant Flow|5ARI Plus AB Combination Therapy|Males aged 50 and older who had a new pharmacy claim for 5ARI and a subsequent claim for AB within one year of the initial 5ARI claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
272457|NCT01323998|P4|Participant Flow|AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI between 30 days and one year of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
272458|NCT01323998|P3|Participant Flow|AB Plus 5ARI Combination Therapy, Early 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI within 30 days of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
272459|NCT01323998|P2|Participant Flow|5 Alpha Reductase Inhibitor (5ARI) Monotherapy|Males aged 50 and older who had a new pharmacy claim for 5ARI monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
272460|NCT01323998|P1|Participant Flow|Alpha-blocker (AB) Monotherapy|Males aged 50 and older who had a new pharmacy claim for AB monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 milligram (mg), or a procedure code for prostate surgery
272461|NCT01323998|O5|Outcome|5ARI Plus AB Combination Therapy|Males aged 50 and older who had a new pharmacy claim for 5ARI and a subsequent claim for AB within one year of the initial 5ARI claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
272462|NCT01323998|O4|Outcome|AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI between 30 days and one year of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
272463|NCT01323998|O3|Outcome|AB Plus 5ARI Combination Therapy, Early 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI within 30 days of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
272464|NCT01323998|O2|Outcome|5 Alpha Reductase Inhibitor (5ARI) Monotherapy|Males aged 50 and older who had a new pharmacy claim for 5ARI monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
272465|NCT01323998|O1|Outcome|Alpha-blocker (AB) Monotherapy|Males aged 50 and older who had a new pharmacy claim for AB monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
272466|NCT01323998|E5|Reported Event|5ARI Plus AB Combination Therapy|Males aged 50 and older who had a new pharmacy claim for 5ARI and a subsequent claim for AB within one year of the initial 5ARI claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
272467|NCT01323998|E4|Reported Event|AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI between 30 days and one year of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
272468|NCT01323998|E3|Reported Event|AB Plus 5ARI Combination Therapy, Early 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI within 30 days of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
272469|NCT01323998|E2|Reported Event|5 Alpha Reductase Inhibitor (5ARI) Monotherapy|Males aged 50 and older who had a new pharmacy claim for 5ARI monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
272470|NCT01323998|E1|Reported Event|Alpha-blocker (AB) Monotherapy|Males aged 50 and older who had a new pharmacy claim for AB monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
272471|NCT01323972|B5|Baseline|Total|Total of all reporting groups
272472|NCT01323972|B4|Baseline|GSK 257049-Pilot Group|Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272473|NCT01323972|B3|Baseline|GSK 257049-Lot 3 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272474|NCT01323972|B2|Baseline|GSK 257049-Lot 2 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272475|NCT01323972|B1|Baseline|GSK 257049-Lot 1 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272476|NCT01323972|P4|Participant Flow|GSK 257049-Pilot Group|Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272477|NCT01323972|P3|Participant Flow|GSK 257049-Lot 3 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272478|NCT01323972|P2|Participant Flow|GSK 257049-Lot 2 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272479|NCT01323972|P1|Participant Flow|GSK 257049-Lot 1 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272480|NCT01323972|O4|Outcome|GSK 257049-Pilot Group|Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272574|NCT01323920|O1|Outcome|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate~Other Names:~Velcade~Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
300203|NCT01247090|E3|Reported Event|Placebo|No Dose - Placebo Comparator
272481|NCT01323972|O3|Outcome|GSK 257049-Lot 3 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272482|NCT01323972|O2|Outcome|GSK 257049-Lot 2 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272483|NCT01323972|O1|Outcome|GSK 257049-Lot 1 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272484|NCT01323972|O4|Outcome|GSK 257049-Pilot Group|Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272485|NCT01323972|O3|Outcome|GSK 257049-Lot 3 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272486|NCT01323972|O2|Outcome|GSK 257049-Lot 2 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272487|NCT01323972|O1|Outcome|GSK 257049-Lot 1 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272488|NCT01323972|O4|Outcome|GSK 257049-Pilot Group|Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272489|NCT01323972|O3|Outcome|GSK 257049-Lot 3 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272490|NCT01323972|O2|Outcome|GSK 257049-Lot 2 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272491|NCT01323972|O1|Outcome|GSK 257049-Lot 1 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272492|NCT01323972|O4|Outcome|GSK 257049-Pilot Group|Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272493|NCT01323972|O3|Outcome|GSK 257049-Lot 3 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272494|NCT01323972|O2|Outcome|GSK 257049-Lot 2 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272495|NCT01323972|O1|Outcome|GSK 257049-Lot 1 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272496|NCT01323972|O5|Outcome|GSK 257049-Pilot Group|Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272497|NCT01323972|O4|Outcome|GSK 257049-Pooled Group|This is a pooled group, made up of GSK 257049-Lot 1 Group, GSK 257049-Lot 2 Group and GSK 257049-Lot 3 Group.
272498|NCT01323972|O3|Outcome|GSK 257049-Lot 3 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272499|NCT01323972|O2|Outcome|GSK 257049-Lot 2 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272500|NCT01323972|O1|Outcome|GSK 257049-Lot 1 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272501|NCT01323972|O5|Outcome|GSK 257049-Pilot Group|Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272502|NCT01323972|O4|Outcome|GSK 257049-Pooled Group|This is a pooled group, made up of GSK 257049-Lot 1 Group, GSK 257049-Lot 2 Group and GSK 257049-Lot 3 Group.
272503|NCT01323972|O3|Outcome|GSK 257049-Lot 3 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272575|NCT01323920|O1|Outcome|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate~Other Names:~Velcade~Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
301248|NCT01244061|B3|Baseline|Total|Total of all reporting groups
272504|NCT01323972|O2|Outcome|GSK 257049-Lot 2 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272505|NCT01323972|O1|Outcome|GSK 257049-Lot 1 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272506|NCT01323972|E4|Reported Event|GSK 257049-Pilot Group|Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272507|NCT01323972|E3|Reported Event|GSK 257049-Lot 3 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272508|NCT01323972|E2|Reported Event|GSK 257049-Lot 2 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272509|NCT01323972|E1|Reported Event|GSK 257049-Lot 1 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
272510|NCT01323959|B4|Baseline|Total|Total of all reporting groups
272511|NCT01323959|B3|Baseline|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272512|NCT01323959|B2|Baseline|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272513|NCT01323959|B1|Baseline|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272514|NCT01323959|P3|Participant Flow|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272515|NCT01323959|P2|Participant Flow|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272516|NCT01323959|P1|Participant Flow|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272517|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272518|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272519|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272520|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272521|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272522|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272523|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272524|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272525|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272526|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272576|NCT01323920|O1|Outcome|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate~Other Names:~Velcade~Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
272527|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272528|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272529|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272530|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272531|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272532|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272533|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272534|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272535|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272536|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272537|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272538|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272539|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272540|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272541|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272542|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272543|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272544|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272545|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272546|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272547|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272548|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272549|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272550|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272551|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272552|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272553|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272554|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272555|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272556|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272557|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272558|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272559|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272560|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272561|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272562|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272563|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272564|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272565|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272566|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272567|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272568|NCT01323959|E3|Reported Event|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272569|NCT01323959|E2|Reported Event|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272570|NCT01323959|E1|Reported Event|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
272571|NCT01323920|B1|Baseline|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate~Other Names:~Velcade~Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
272572|NCT01323920|P1|Participant Flow|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate~Other Names:~Velcade~Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
272573|NCT01323920|O1|Outcome|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate~Other Names:~Velcade~Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
301638|NCT01242514|O2|Outcome|Fostamatinib 150 mg qd|Oral treatment
272577|NCT01323920|E1|Reported Event|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate~Other Names:~Velcade~Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
272578|NCT01323855|B6|Baseline|Total|Total of all reporting groups
272579|NCT01323855|B5|Baseline|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272580|NCT01323855|B4|Baseline|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272581|NCT01323855|B3|Baseline|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272582|NCT01323855|B2|Baseline|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272583|NCT01323855|B1|Baseline|Part 1: Severe Renal Impairment|Participants with severe CRI, defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272584|NCT01323855|P5|Participant Flow|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272585|NCT01323855|P4|Participant Flow|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272586|NCT01323855|P3|Participant Flow|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272587|NCT01323855|P2|Participant Flow|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272588|NCT01323855|P1|Participant Flow|Part 1: Severe Renal Impairment|Participants with severe chronic renal impairment (CRI), defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272589|NCT01323855|O5|Outcome|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272590|NCT01323855|O4|Outcome|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272591|NCT01323855|O3|Outcome|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272592|NCT01323855|O2|Outcome|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272593|NCT01323855|O1|Outcome|Part 1: Severe Renal Impairment|Participants with severe CRI, defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272594|NCT01323855|O5|Outcome|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272595|NCT01323855|O4|Outcome|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272596|NCT01323855|O3|Outcome|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272597|NCT01323855|O2|Outcome|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272598|NCT01323855|O1|Outcome|Part 1: Severe Renal Impairment|Participants with severe CRI, defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272599|NCT01323855|O5|Outcome|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272600|NCT01323855|O4|Outcome|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272601|NCT01323855|O3|Outcome|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272602|NCT01323855|O2|Outcome|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272603|NCT01323855|O1|Outcome|Part 1: Severe Renal Impairment|Participants with severe CRI, defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272604|NCT01323855|E5|Reported Event|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272605|NCT01323855|E4|Reported Event|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272606|NCT01323855|E3|Reported Event|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272607|NCT01323855|E2|Reported Event|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272608|NCT01323855|E1|Reported Event|Part 1: Severe Renal Impairment|Participants with severe CRI, defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
272609|NCT01323790|B4|Baseline|Total|Total of all reporting groups
272610|NCT01323790|B3|Baseline|Placebo|Placebo QD, oral treatment
272611|NCT01323790|B2|Baseline|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
272612|NCT01323790|B1|Baseline|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
272613|NCT01323790|P3|Participant Flow|Placebo|Placebo QD, oral treatment
272614|NCT01323790|P2|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
272615|NCT01323790|P1|Participant Flow|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
272616|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
272617|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
272618|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
272619|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
272620|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
272621|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
272622|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
272623|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
272624|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
272625|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
272626|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
272627|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
272628|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
272629|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
272630|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
272631|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
272632|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
272633|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
272634|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
272635|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
272636|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
272637|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
272638|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
272639|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
272640|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
272641|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
272642|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
272643|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
272644|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
272645|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
272646|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
272647|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
272648|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
272649|NCT01323790|E3|Reported Event|Placebo|
272650|NCT01323790|E2|Reported Event|NKTR-118 25 mg|
272651|NCT01323790|E1|Reported Event|NKTR-118 12.5 mg|
272652|NCT01323777|B1|Baseline|ReSTOR +3.0|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
272653|NCT01323777|P1|Participant Flow|ReSTOR +3.0|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
272654|NCT01323777|O3|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
272655|NCT01323777|O2|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
272656|NCT01323777|O1|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
272657|NCT01323777|O5|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
272658|NCT01323777|O4|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
272659|NCT01323777|O3|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
272660|NCT01323777|O2|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
272661|NCT01323777|O1|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
272662|NCT01323777|E1|Reported Event|ReSTOR +3.0|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
272663|NCT01323673|B3|Baseline|Total|Total of all reporting groups
272664|NCT01323673|B2|Baseline|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
272665|NCT01323673|B1|Baseline|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
272666|NCT01323673|P2|Participant Flow|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
272667|NCT01323673|P1|Participant Flow|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
272835|NCT01323387|E1|Reported Event|Treatment|Interbody fusions with Anterior Plating
272668|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
272669|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
272670|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
272671|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
272672|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
272673|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
272674|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
272675|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
272676|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
272677|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
272678|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
272679|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
272680|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
272681|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
272682|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
272683|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
272684|NCT01323673|E2|Reported Event|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
272685|NCT01323673|E1|Reported Event|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
272686|NCT01323660|B1|Baseline|All Study Treatments|Participants were randomized to receive a sequence consisting of 2 of the following treatments: UMEC/VI 125/25 µg , UMEC/VI 62.5/25 µg , UMEC 125 µg , UMEC 62.5 µg , VI 25 µg , or placebo QD via a DPI. Each treatment was administered in the morning for 12 weeks. The treatment periods were seperated by 14-day washout period.
272687|NCT01323660|P6|Participant Flow|UMEC 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
272688|NCT01323660|P5|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
272689|NCT01323660|P4|Participant Flow|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
272690|NCT01323660|P3|Participant Flow|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
272691|NCT01323660|P2|Participant Flow|UMEC 62.5 µg QD|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) QD via a DPI in the morning for 12 weeks.
272692|NCT01323660|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 12weeks.
272693|NCT01323660|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
272694|NCT01323660|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
272695|NCT01323660|O4|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
272696|NCT01323660|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
272697|NCT01323660|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
272698|NCT01323660|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
272699|NCT01323660|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
272836|NCT01323270|B3|Baseline|Total|Total of all reporting groups
272700|NCT01323660|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
272701|NCT01323660|O4|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
272702|NCT01323660|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
272703|NCT01323660|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
272704|NCT01323660|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
272705|NCT01323660|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
272706|NCT01323660|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
272707|NCT01323660|O4|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
272708|NCT01323660|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
272709|NCT01323660|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
272710|NCT01323660|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
272711|NCT01323660|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
272712|NCT01323660|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
272713|NCT01323660|O4|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
272714|NCT01323660|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
272715|NCT01323660|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
272716|NCT01323660|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
272717|NCT01323660|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
272718|NCT01323660|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
272719|NCT01323660|O4|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
272720|NCT01323660|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
272721|NCT01323660|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
272722|NCT01323660|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
272723|NCT01323660|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
272724|NCT01323660|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
272725|NCT01323660|O4|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
272726|NCT01323660|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
272727|NCT01323660|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
272728|NCT01323660|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
272729|NCT01323660|E6|Reported Event|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
272730|NCT01323660|E5|Reported Event|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
272731|NCT01323660|E4|Reported Event|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
272732|NCT01323660|E3|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
272733|NCT01323660|E2|Reported Event|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
272734|NCT01323660|E1|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
272735|NCT01323647|B3|Baseline|Total|Total of all reporting groups
272736|NCT01323647|B2|Baseline|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
272737|NCT01323647|B1|Baseline|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
272738|NCT01323647|P2|Participant Flow|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
272739|NCT01323647|P1|Participant Flow|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
272740|NCT01323647|O2|Outcome|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
272741|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
272742|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
272743|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
272744|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
272797|NCT01323582|O2|Outcome|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
272745|NCT01323647|O2|Outcome|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
272746|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
272747|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
272748|NCT01323647|O2|Outcome|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
272749|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
272750|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
272751|NCT01323647|E2|Reported Event|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
272752|NCT01323647|E1|Reported Event|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
272753|NCT01323634|B3|Baseline|Total|Total of all reporting groups
272754|NCT01323634|B2|Baseline|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
272755|NCT01323634|B1|Baseline|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
272756|NCT01323634|P3|Participant Flow|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
272757|NCT01323634|P2|Participant Flow|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
272758|NCT01323634|P1|Participant Flow|Placebo + Salbutamol|Participants were instructed to take single-blind placebo (ACCUHALER/DISKUS and Novel Dry Powder Inhaler [NDPI]): one inhalation each morning from each device, and one inhalation from the ACCUHALER/DISKUS in the evening. In addition, all participants received supplemental albuterol (salbutamol) (metered dose inhaler [MDI] and/or nebules) to be used on an as-needed basis. Ipratropium bromide alone was permitted, provided that the participant was on a stable dose from Visit 1 (Screening) and remained on the stable dose throughout the study; however, ipratropium must have been withheld for 4 hours prior to and during each clinic visit.
272759|NCT01323634|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
272760|NCT01323634|O1|Outcome|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
272761|NCT01323634|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
272762|NCT01323634|O1|Outcome|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
272763|NCT01323634|E2|Reported Event|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
272764|NCT01323634|E1|Reported Event|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
272765|NCT01323621|B3|Baseline|Total|Total of all reporting groups
272766|NCT01323621|B2|Baseline|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
272767|NCT01323621|B1|Baseline|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
272768|NCT01323621|P3|Participant Flow|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
272769|NCT01323621|P2|Participant Flow|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
272770|NCT01323621|P1|Participant Flow|Placebo + Salbutamol|Participants were instructed to take single-blind placebo (ACCUHALER/DISKUS and Novel Dry Powder Inhaler [NDPI]): one inhalation each morning from each device, and one inhalation from the ACCUHALER/DISKUS in the evening. In addition, all participants received supplemental albuterol (salbutamol) (metered dose inhaler [MDI] and/or nebules) to be used on an as-needed basis. Ipratropium bromide alone was permitted, provided that the participant was on a stable dose from Visit 1 (Screening) and remained on the stable dose throughout the study; however, Ipratropium must have been withheld for 4 hours prior to and during each clinic visit.
272771|NCT01323621|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
272772|NCT01323621|O1|Outcome|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
272773|NCT01323621|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
272774|NCT01323621|O1|Outcome|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
272775|NCT01323621|E2|Reported Event|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
272776|NCT01323621|E1|Reported Event|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
272777|NCT01323595|B3|Baseline|Total|Total of all reporting groups
272778|NCT01323595|B2|Baseline|Sugar Pill|"Sugar pill for 6 days after surgery.~Sugar Pill : Sugar pill PO BID x 6 days"
272779|NCT01323595|B1|Baseline|Celecoxib|"Celecoxib will be given for 6 days after surgery~Celecoxib : Celecoxib 200mg PO BID x 6 days"
272780|NCT01323595|P2|Participant Flow|Sugar Pill|"Sugar pill for 5 days after surgery.~Sugar Pill : Sugar pill PO BID x 6 days"
272781|NCT01323595|P1|Participant Flow|Celecoxib|"Celecoxib will be given for 5 days after surgery~Celecoxib : Celecoxib 200mg PO BID x 6 days"
272782|NCT01323595|O2|Outcome|Celecoxib|Patients received celecoxib
272783|NCT01323595|O1|Outcome|Placebo Treatment|Patients received placebo medication
272784|NCT01323595|E2|Reported Event|Celecoxib|Patients received celecoxib
272785|NCT01323595|E1|Reported Event|Placebo Treatment|Patients received placebo medication
272786|NCT01323582|B3|Baseline|Total|Total of all reporting groups
272787|NCT01323582|B2|Baseline|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
272788|NCT01323582|B1|Baseline|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
272789|NCT01323582|P2|Participant Flow|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
272790|NCT01323582|P1|Participant Flow|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
272791|NCT01323582|O1|Outcome|Azithromycin|The dose of Azithromycin given was previously determined based on our dose-response analysis in 10 healthy subjects to be 50 mg. The total daily dosage of Azithromycin given therefore was 150 mg which was divided three times daily and administered as 50mg/5ml given three times a day as elixir orally, similar to the erythromycin volume.
272792|NCT01323582|O1|Outcome|Erythromycin|"200mg/5ml elixir administered orally three times a day half an hour prior to meals.~Erythromycin: 200mg/5ml elixir administered orally three times a day half an hour prior to meals."
272793|NCT01323582|O1|Outcome|Azithromycin|The dose of Azithromycin given was previously determined based on our dose-response analysis in 10 healthy subjects to be 50 mg. The total daily dosage of Azithromycin given therefore was 150 mg which was divided three times daily and administered as 50mg/5ml given three times a day as elixir orally, similar to the erythromycin volume.
272794|NCT01323582|O1|Outcome|Erythromycin|"200mg/5ml elixir administered orally three times a day half an hour prior to meals.~Erythromycin: 200mg/5ml elixir administered orally three times a day half an hour prior to meals."
272795|NCT01323582|O2|Outcome|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
272796|NCT01323582|O1|Outcome|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
272834|NCT01323387|O1|Outcome|Treatment|Interbody fusions with Anterior Plating
272798|NCT01323582|O1|Outcome|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
272799|NCT01323582|O2|Outcome|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
272800|NCT01323582|O1|Outcome|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
272801|NCT01323582|O2|Outcome|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
272802|NCT01323582|O1|Outcome|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
272803|NCT01323582|E2|Reported Event|Azithromycin|The dose of Azithromycin given was previously determined based on our dose-response analysis in 10 healthy subjects to be 50 mg. The total daily dosage of Azithromycin given therefore was 150 mg which was divided three times daily and administered as 50mg/5ml given three times a day as elixir orally, similar to the erythromycin volume.
272804|NCT01323582|E1|Reported Event|Erythromycin|"200mg/5ml elixir administered orally three times a day half an hour prior to meals.~Erythromycin: 200mg/5ml elixir administered orally three times a day half an hour prior to meals."
272805|NCT01323517|B1|Baseline|Ipilimumab, Melphalan and Dactinomycin|Ipilimumab, Melphalan and Dactinomycin: Isolated limb infusion ((ILI) with Melphalan and Dactinomycin- MSKCC operating room. Ipilimumab- IV administration in outpatient chemotherapy clinic. Induction therapy with Ipilimumab will start 1-3 weeks after ILI in the standard dose of 10mg/kg every 3 weeks for a total of 4 doses. Patients will then receive chronic therapy every 3 months. Patients will be followed every 3 months for 2 years.
272806|NCT01323517|P1|Participant Flow|Ipilimumab, Melphalan and Dactinomycin|Ipilimumab, Melphalan and Dactinomycin: Isolated limb infusion ((ILI) with Melphalan and Dactinomycin- MSKCC operating room. Ipilimumab- IV administration in outpatient chemotherapy clinic. Induction therapy with Ipilimumab will start 1-3 weeks after ILI in the standard dose of 10mg/kg every 3 weeks for a total of 4 doses. Patients will then receive chronic therapy every 3 months. Patients will be followed every 3 months for 2 years.
272807|NCT01323517|O1|Outcome|Ipilimumab, Melphalan and Dactinomycin|Ipilimumab, Melphalan and Dactinomycin: Isolated limb infusion ((ILI) with Melphalan and Dactinomycin- MSKCC operating room. Ipilimumab- IV administration in outpatient chemotherapy clinic. Induction therapy with Ipilimumab will start 1-3 weeks after ILI in the standard dose of 10mg/kg every 3 weeks for a total of 4 doses. Patients will then receive chronic therapy every 3 months. Patients will be followed every 3 months for 2 years.
272808|NCT01323517|O1|Outcome|Ipilimumab, Melphalan and Dactinomycin|Ipilimumab, Melphalan and Dactinomycin: Isolated limb infusion ((ILI) with Melphalan and Dactinomycin- MSKCC operating room. Ipilimumab- IV administration in outpatient chemotherapy clinic. Induction therapy with Ipilimumab will start 1-3 weeks after ILI in the standard dose of 10mg/kg every 3 weeks for a total of 4 doses. Patients will then receive chronic therapy every 3 months. Patients will be followed every 3 months for 2 years.
272809|NCT01323517|O1|Outcome|Ipilimumab, Melphalan and Dactinomycin|Ipilimumab, Melphalan and Dactinomycin: Isolated limb infusion ((ILI) with Melphalan and Dactinomycin- MSKCC operating room. Ipilimumab- IV administration in outpatient chemotherapy clinic. Induction therapy with Ipilimumab will start 1-3 weeks after ILI in the standard dose of 10mg/kg every 3 weeks for a total of 4 doses. Patients will then receive chronic therapy every 3 months. Patients will be followed every 3 months for 2 years.
272810|NCT01323517|O1|Outcome|Ipilimumab, Melphalan and Dactinomycin|Ipilimumab, Melphalan and Dactinomycin: Isolated limb infusion ((ILI) with Melphalan and Dactinomycin- MSKCC operating room. Ipilimumab- IV administration in outpatient chemotherapy clinic. Induction therapy with Ipilimumab will start 1-3 weeks after ILI in the standard dose of 10mg/kg every 3 weeks for a total of 4 doses. Patients will then receive chronic therapy every 3 months. Patients will be followed every 3 months for 2 years.
272811|NCT01323517|E1|Reported Event|Ipilimumab, Melphalan and Dactinomycin|Ipilimumab, Melphalan and Dactinomycin: Isolated limb infusion ((ILI) with Melphalan and Dactinomycin- MSKCC operating room. Ipilimumab- IV administration in outpatient chemotherapy clinic. Induction therapy with Ipilimumab will start 1-3 weeks after ILI in the standard dose of 10mg/kg every 3 weeks for a total of 4 doses. Patients will then receive chronic therapy every 3 months. Patients will be followed every 3 months for 2 years.
272812|NCT01323478|B1|Baseline|Vortioxetine 15 or 20 mg/Day|
272813|NCT01323478|P1|Participant Flow|Vortioxetine 15 or 20 mg/Day|
272814|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
272815|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
272816|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
272817|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
272818|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
272819|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
272820|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
272821|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
272822|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
272823|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
272824|NCT01323478|E1|Reported Event|Vortioxetine 15 or 20 mg/Day|
272825|NCT01323387|B1|Baseline|Treatment|Interbody fusions with Anterior Plating
272826|NCT01323387|P1|Participant Flow|Treatment|Interbody fusions with Anterior Plating
272827|NCT01323387|O1|Outcome|Treatment|Interbody fusions with Anterior Plating
272828|NCT01323387|O1|Outcome|Treatment|Interbody fusions with Anterior Plating
272829|NCT01323387|O1|Outcome|Treatment|Interbody fusions with Anterior Plating
272830|NCT01323387|O1|Outcome|Physical Health Composite Score (MCS)|A self-reported quality of life assessment to measure a participant's interpretation of their physical well-being. A 15% improvement was considered a success.
272831|NCT01323387|O1|Outcome|Treatment|Interbody fusions with Anterior Plating
272832|NCT01323387|O1|Outcome|Treatment|Interbody fusions with Anterior Plating
272833|NCT01323387|O1|Outcome|Physical Health Composite Score (PCS)|A self-reported quality of life assessment to measure a participant's interpretation of their physical well-being. A 15% improvement was considered a success.
272837|NCT01323270|B2|Baseline|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
272838|NCT01323270|B1|Baseline|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
272839|NCT01323270|P2|Participant Flow|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
272840|NCT01323270|P1|Participant Flow|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
272841|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
272842|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
272843|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
272844|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
272845|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
272846|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
272847|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
272848|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
272849|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month
272850|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
272851|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
272852|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
272853|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
272854|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
272855|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
272856|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
272857|NCT01323270|E2|Reported Event|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
272858|NCT01323270|E1|Reported Event|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
272859|NCT01323192|B3|Baseline|Total|Total of all reporting groups
272860|NCT01323192|B2|Baseline|Placebo|Participants received matching placebo orally once daily for 8 weeks.
272861|NCT01323192|B1|Baseline|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
272862|NCT01323192|P2|Participant Flow|Placebo|Participants received matching placebo orally once daily for 8 weeks.
272863|NCT01323192|P1|Participant Flow|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
272864|NCT01323192|O2|Outcome|Placebo|Participants received matching placebo orally once daily for 8 weeks.
272865|NCT01323192|O1|Outcome|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
272866|NCT01323192|O2|Outcome|Placebo|Participants received matching placebo orally once daily for 8 weeks.
272867|NCT01323192|O1|Outcome|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
272868|NCT01323192|O2|Outcome|Placebo|Participants received matching placebo orally once daily for 8 weeks.
272869|NCT01323192|O1|Outcome|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
272870|NCT01323192|O2|Outcome|Placebo|Participants received matching placebo orally once daily for 8 weeks.
272871|NCT01323192|O1|Outcome|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
272872|NCT01323192|O2|Outcome|Placebo|Participants received matching placebo orally once daily for 8 weeks.
272873|NCT01323192|O1|Outcome|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
272874|NCT01323192|O2|Outcome|Placebo|Participants received matching placebo orally once daily for 8 weeks.
272875|NCT01323192|O1|Outcome|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
272876|NCT01323192|E2|Reported Event|Placebo|Participants received matching placebo orally once daily for 8 weeks.
272877|NCT01323192|E1|Reported Event|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
272878|NCT01323140|B1|Baseline|Treatment|
272879|NCT01323140|P1|Participant Flow|Treatment|
272880|NCT01323140|O1|Outcome|Treatment|As specified in the Protocol, subjects were dose-titrated during treatment and subjects at all resulting dose levels were pooled for primary efficacy analysis. After dose-titration, 20 subjects were receiving TMTS at dose level B (one 48 cm2 TMTS) and 18 subjects were receiving TMTS at dose level C (one 48 cm2 and one 28 cm2 TMTS). See also Arm description.
272881|NCT01323140|E1|Reported Event|Treatment|
272882|NCT01323010|B3|Baseline|Total|Total of all reporting groups
272883|NCT01323010|B2|Baseline|Control Group|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
272884|NCT01323010|B1|Baseline|Experimental Group|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
272885|NCT01323010|P2|Participant Flow|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
273795|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
272886|NCT01323010|P1|Participant Flow|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
272887|NCT01323010|O3|Outcome|Arg16Arg Patients|Patients carrying the Arg16Arg genotype
272888|NCT01323010|O2|Outcome|Gly16Gly Patients|Patients carrying the Gly16Gly genotype
272889|NCT01323010|O1|Outcome|Arg16Gly Patients|Patients carrying the Arg16Gly genotype
272890|NCT01323010|O2|Outcome|No Rhinovirus Detected|patients with no rhinovirus detected by PCR
272891|NCT01323010|O1|Outcome|Rhinovirus Detected|patients with rhinovirus detected by PCR
272892|NCT01323010|O2|Outcome|No Virus Detected|patients with no virus detected by PCR
272893|NCT01323010|O1|Outcome|Virus Detected|patients with any virus detected by PCR
272894|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
272895|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
272896|NCT01323010|O2|Outcome|Control Group|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
272897|NCT01323010|O1|Outcome|Experimental Group|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
272898|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
272899|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
272900|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
272901|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
272902|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
272903|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
272904|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
272905|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
272906|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
272907|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
272908|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
272909|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
272910|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
272911|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
272912|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
273027|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
272913|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
272914|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
272915|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
272916|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
272917|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
272918|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
272919|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
272920|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
272921|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
272922|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
272923|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
272924|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
272925|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
272926|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing was dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group received 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
272927|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing was individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group received higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
272928|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing was individualized according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group received 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
272929|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing was individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group received higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
272930|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing was dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group received 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
272931|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing was individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group received higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
272932|NCT01323010|E2|Reported Event|Control Group|"Dosing was dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group received 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
272933|NCT01323010|E1|Reported Event|Experimental Group|"Dosing was individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group received higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
272934|NCT01322971|B3|Baseline|Total|Total of all reporting groups
272935|NCT01322971|B2|Baseline|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm~Placebo: Placebo will be administered orally twice daily for seven days"
272936|NCT01322971|B1|Baseline|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.~Metronidazole: Metronidazole 500mg orally twice daily for seven days"
272937|NCT01322971|P2|Participant Flow|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm~Placebo: Placebo will be administered orally twice daily for seven days"
272938|NCT01322971|P1|Participant Flow|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.~Metronidazole: Metronidazole 500mg orally twice daily for seven days"
272939|NCT01322971|O2|Outcome|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm~Placebo: Placebo will be administered orally twice daily for seven days"
272940|NCT01322971|O1|Outcome|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.~Metronidazole: Metronidazole 500mg orally twice daily for seven days"
272941|NCT01322971|O2|Outcome|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm~Placebo: Placebo will be administered orally twice daily for seven days"
272942|NCT01322971|O1|Outcome|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.~Metronidazole: Metronidazole 500mg orally twice daily for seven days"
272943|NCT01322971|O2|Outcome|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm~Placebo: Placebo will be administered orally twice daily for seven days"
272944|NCT01322971|O1|Outcome|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.~Metronidazole: Metronidazole 500mg orally twice daily for seven days"
272945|NCT01322971|O2|Outcome|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm~Placebo: Placebo will be administered orally twice daily for seven days"
272946|NCT01322971|O1|Outcome|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.~Metronidazole: Metronidazole 500mg orally twice daily for seven days"
272947|NCT01322971|E2|Reported Event|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm~Placebo: Placebo will be administered orally twice daily for seven days"
272948|NCT01322971|E1|Reported Event|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.~Metronidazole: Metronidazole 500mg orally twice daily for seven days"
272949|NCT01322945|B3|Baseline|Total|Total of all reporting groups
272950|NCT01322945|B2|Baseline|Control Group|Patients undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
272951|NCT01322945|B1|Baseline|Endonasal Group|Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
272952|NCT01322945|P2|Participant Flow|Control Group|Patients undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
272953|NCT01322945|P1|Participant Flow|Endonasal Group|Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
272954|NCT01322945|O2|Outcome|Control Group|First 10 patients enrolled undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
272955|NCT01322945|O1|Outcome|Endonasal Group|First 12 patients enrolled undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
272956|NCT01322945|O2|Outcome|Control Group|Patients undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
272957|NCT01322945|O1|Outcome|Endonasal Group|Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
272958|NCT01322945|E2|Reported Event|Control Group|Patients undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
272959|NCT01322945|E1|Reported Event|Endonasal Group|Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
272960|NCT01322841|B3|Baseline|Total|Total of all reporting groups
272961|NCT01322841|B2|Baseline|CHICA Placebo|This arm had CHICA but no additional module CHICA Placebo: This was CHICA without the screening module
272962|NCT01322841|B1|Baseline|CHICA Diagnosis Module|This arm had the CHICA screening module turned on CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia
272963|NCT01322841|P2|Participant Flow|CHICA Placebo|This arm had CHICA but no additional module CHICA Placebo: This was CHICA without the screening module
272964|NCT01322841|P1|Participant Flow|CHICA Diagnosis Module|This arm had the CHICA screening module turned on CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia
272965|NCT01322841|O2|Outcome|CHICA Placebo|"This arm had CHICA but no additional module~CHICA Placebo: This was CHICA without the screening module"
272966|NCT01322841|O1|Outcome|CHICA Diagnosis Module|"This arm had the CHICA screening module turned on~CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia"
272967|NCT01322841|O2|Outcome|CHICA Placebo|"This arm had CHICA but no additional module~CHICA Placebo: This was CHICA without the screening module"
272968|NCT01322841|O1|Outcome|CHICA Diagnosis Module|"This arm had the CHICA screening module turned on~CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia"
272969|NCT01322841|E2|Reported Event|CHICA Placebo|"This arm had CHICA but no additional module~CHICA Placebo: This was CHICA without the screening module"
273025|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
272970|NCT01322841|E1|Reported Event|CHICA Diagnosis Module|"This arm had the CHICA screening module turned on~CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia"
272971|NCT01322815|B3|Baseline|Total|Total of all reporting groups
272972|NCT01322815|B2|Baseline|GI-4000 and Bevacizumab|"maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy~GI-4000: 40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks"
272973|NCT01322815|B1|Baseline|Chemotherapy and GI-4000|"Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks~chemotherapy and GI-4000: Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks"
272974|NCT01322815|P2|Participant Flow|GI-4000 and Bevacizumab|"maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy~GI-4000: 40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks"
272975|NCT01322815|P1|Participant Flow|Chemotherapy and GI-4000|"Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks~chemotherapy and GI-4000: Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks"
272976|NCT01322815|O2|Outcome|GI-4000 and Bevacizumab|"maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy~GI-4000: 40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks"
272977|NCT01322815|O1|Outcome|Chemotherapy and GI-4000|"Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks~chemotherapy and GI-4000: Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks"
272978|NCT01322815|E2|Reported Event|GI-4000 and Bevacizumab|"maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy~GI-4000: 40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks"
272979|NCT01322815|E1|Reported Event|Chemotherapy and GI-4000|"Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks~chemotherapy and GI-4000: Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks"
272980|NCT01322633|B3|Baseline|Total|Total of all reporting groups
272981|NCT01322633|B2|Baseline|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
272982|NCT01322633|B1|Baseline|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
272983|NCT01322633|P2|Participant Flow|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
272984|NCT01322633|P1|Participant Flow|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
272985|NCT01322633|O2|Outcome|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
272986|NCT01322633|O1|Outcome|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
272987|NCT01322633|O2|Outcome|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
272988|NCT01322633|O1|Outcome|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
272989|NCT01322633|O2|Outcome|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
273026|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
301639|NCT01242514|O1|Outcome|Fostamatinib 100 mg Bid|Oral treatment
272990|NCT01322633|O1|Outcome|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
272991|NCT01322633|E2|Reported Event|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
272992|NCT01322633|E1|Reported Event|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
272993|NCT01322607|B3|Baseline|Total|Total of all reporting groups
272994|NCT01322607|B2|Baseline|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)~Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
272995|NCT01322607|B1|Baseline|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise~High-intensity Treadmill Exercise: High-intensity treadmill walking program"
272996|NCT01322607|P2|Participant Flow|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)~Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
272997|NCT01322607|P1|Participant Flow|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise~High-intensity Treadmill Exercise: High-intensity treadmill walking program"
272998|NCT01322607|O2|Outcome|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)~Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
272999|NCT01322607|O1|Outcome|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise~High-intensity Treadmill Exercise: High-intensity treadmill walking program"
273000|NCT01322607|O2|Outcome|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)~Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
273001|NCT01322607|O1|Outcome|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise~High-intensity Treadmill Exercise: High-intensity treadmill walking program"
273002|NCT01322607|O2|Outcome|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)~Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
273003|NCT01322607|O1|Outcome|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise~High-intensity Treadmill Exercise: High-intensity treadmill walking program"
273004|NCT01322607|O2|Outcome|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)~Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
273005|NCT01322607|O1|Outcome|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise~High-intensity Treadmill Exercise: High-intensity treadmill walking program"
273006|NCT01322607|E2|Reported Event|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)~Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
273007|NCT01322607|E1|Reported Event|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise~High-intensity Treadmill Exercise: High-intensity treadmill walking program"
273008|NCT01322594|B7|Baseline|Total|Total of all reporting groups
273009|NCT01322594|B6|Baseline|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273010|NCT01322594|B5|Baseline|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273011|NCT01322594|B4|Baseline|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273012|NCT01322594|B3|Baseline|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273013|NCT01322594|B2|Baseline|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
273014|NCT01322594|B1|Baseline|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273015|NCT01322594|P6|Participant Flow|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273016|NCT01322594|P5|Participant Flow|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273017|NCT01322594|P4|Participant Flow|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273018|NCT01322594|P3|Participant Flow|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273019|NCT01322594|P2|Participant Flow|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
273020|NCT01322594|P1|Participant Flow|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273021|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273022|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273023|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273024|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273028|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273029|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273030|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273031|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273032|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
273033|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273034|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273035|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273036|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273037|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273038|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
273039|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273040|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273041|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273042|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273043|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273044|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
273045|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273046|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273047|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273048|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273049|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273050|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
273051|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273052|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273053|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273054|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273055|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273056|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
273057|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273058|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273059|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273060|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273061|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273062|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
273063|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273064|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273065|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273066|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273067|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273068|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
273069|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273070|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273071|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273072|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273073|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273074|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
273075|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273076|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273077|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273078|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273079|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273080|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
273081|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273082|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273083|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273084|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273085|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273086|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
273087|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273088|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273089|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273090|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273091|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
273092|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
273093|NCT01322594|E6|Reported Event|MEDI2338 1000 MG|
273094|NCT01322594|E5|Reported Event|MEDI2338 300 MG|
273095|NCT01322594|E4|Reported Event|MEDI2338 100 MG|
273096|NCT01322594|E3|Reported Event|MEDI2338 30 MG|
273097|NCT01322594|E2|Reported Event|MEDI2338 10 MG|
273098|NCT01322594|E1|Reported Event|Placebo|
273099|NCT01322386|B3|Baseline|Total|Total of all reporting groups
273100|NCT01322386|B2|Baseline|Oral Vancomycin - PSC|Enrolled- 11, Participated - 10 ,Completed - 9 (Based on Annual Progress Report in Oct 2010)
273101|NCT01322386|B1|Baseline|Oral Vancomycin-BIliary Atresia|Enrolled- 10, Participated - 10,Completed - 10 (Based on Annual Progress Report in Oct 2010)
273102|NCT01322386|P2|Participant Flow|Oral Vancomycin/ Primary Sclerosing Cholangitis|Vancomycin: Oral 50mg/Kg per day up to maximum of 1500 mg a day for three months. Initially 10 children with Primary Sclerosing Cholangitis (PSC) were planned for this study to determine if there was clinical response to oral vancomycin.
273103|NCT01322386|P1|Participant Flow|Oral Vancomycin-Biliary Atresia|Vancomycin: Oral 50mg/Kg per day for three months. Initially 10 infants with Biliary Atresia (BA) were planned for this study to determine if there was clinical response to oral vancomycin.
273104|NCT01322386|O5|Outcome|Liver Biopsy and/or MRI|BA-N/A , PSC- 8/9 participants showed improvement of liver biopsies and/or MRI on Vancomycin.
273105|NCT01322386|O4|Outcome|Colon Biopsies|BA - N/A , PSC - 8/8- who had colonoscopies with colon biopsies showed improvement on Vancomycin therapy.
273106|NCT01322386|O3|Outcome|Liver Biopsy|BA - N/A , PSC - 4/4 who had Liver biopsies showed improvement on Vancomycin therapy.
273107|NCT01322386|O2|Outcome|MRI / MRCP|BA-N/A, PSC - 7/7 showed improvement on Vancomycin therapy.
273108|NCT01322386|O1|Outcome|Liver Blood Test|BA -10/10 , PSC - 9/9 - All had improvement on Vancomycin therapy.
273109|NCT01322386|E1|Reported Event|BA/PSC -Oral Vancomycin|Oral Vancomycin is commercially available (Vancocin, ViroPharma Inc.) for treatment of gastrointestinal infection such as, Clostridium difficile infection. In fact, our published observation of using oral vancomycin in treating PSC was an incidental finding to our treatment for Cl. Difficile gastrointestinal infection in a child with PSC (J Pediatr Gastroenterol Nutr 27:580-3, 1998). Since oral vancomycin is poorly absorbed, no serious adverse events were anticipated in this study.
273110|NCT01322360|B1|Baseline|Morphine Sulfate|Morphine sulfate oral solution and Morphine sulfate tablets
273111|NCT01322360|P1|Participant Flow|Morphine Sulfate|Morphine sulfate oral solution and Morphine sulfate tablets
273112|NCT01322360|O1|Outcome|Morphine Sulfate|"oral solution (10 mg/5 mL or 20 mg/5 mL) or tablets (15 mg or 30 mg)given based on based on the current pediatric prescribing guidelines~Morphine Sulfate"
273113|NCT01322360|O1|Outcome|Morphine Sulfate|Subjects received morphine sulfate either as oral solution or tablet.
273114|NCT01322360|E1|Reported Event|Morphine Sulfate|Morphine sulfate oral solution and Morphine sulfate tablets
273115|NCT01322347|B3|Baseline|Total|Total of all reporting groups
273116|NCT01322347|B2|Baseline|Standard Dialysate (Placebo)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
274305|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
273117|NCT01322347|B1|Baseline|Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
273118|NCT01322347|P2|Participant Flow|Standard Dialysate (Placebo)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
273119|NCT01322347|P1|Participant Flow|Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
273120|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
273121|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
273122|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
273123|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
273124|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
273125|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
273126|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
273127|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
273128|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
273129|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
273130|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
273131|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
273132|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
273133|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
273134|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
273135|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
273136|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
273137|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
273138|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
273139|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
273140|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
273141|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
273142|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
273143|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
273144|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
273145|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
273146|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
273147|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
273148|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
273149|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
273150|NCT01322347|E3|Reported Event|Stage 3 Soluble Ferric Pyrophosphate (SFP)|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Upon completion of Stage 2, patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 3 for up to 72 weeks of total study participation (Stage 2 + Stage 3)."
273151|NCT01322347|E2|Reported Event|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks."
273152|NCT01322347|E1|Reported Event|Stage 2 Standard Dialysate (Placebo)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks."
273153|NCT01322048|B3|Baseline|Total|Total of all reporting groups
273154|NCT01322048|B2|Baseline|Placebo|"Placebo~Placebo: Placebo IV q6h and Per Tube q12, both for 7 days"
273155|NCT01322048|B1|Baseline|Adrenergic Blockade|"Propranolol and Clonidine~IV Propranolol and Per Tube Clonidine: 1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days"
273156|NCT01322048|P2|Participant Flow|Placebo|"Placebo~Placebo: Placebo IV q6h and Per Tube q12, both for 7 days"
273157|NCT01322048|P1|Participant Flow|Adrenergic Blockade|"Propranolol and Clonidine~IV Propranolol and Per Tube Clonidine: 1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days"
273158|NCT01322048|O2|Outcome|Placebo|"Placebo~Placebo: Placebo IV q6h and Per Tube q12, both for 7 days"
273159|NCT01322048|O1|Outcome|Adrenergic Blockade|"Propranolol and Clonidine~IV Propranolol and Per Tube Clonidine: 1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days"
273160|NCT01322048|O2|Outcome|Placebo|"Placebo~Placebo: Placebo IV q6h and Per Tube q12, both for 7 days"
273161|NCT01322048|O1|Outcome|Adrenergic Blockade|"Propranolol and Clonidine~IV Propranolol and Per Tube Clonidine: 1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days"
273162|NCT01322048|E2|Reported Event|Placebo|"Placebo~Placebo: Placebo IV q6h and Per Tube q12, both for 7 days"
273163|NCT01322048|E1|Reported Event|Adrenergic Blockade|"Propranolol and Clonidine~IV Propranolol and Per Tube Clonidine: 1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days"
273164|NCT01322022|B3|Baseline|Total|Total of all reporting groups
273165|NCT01322022|B2|Baseline|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
273166|NCT01322022|B1|Baseline|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
273167|NCT01322022|P2|Participant Flow|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
273168|NCT01322022|P1|Participant Flow|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
273169|NCT01322022|O2|Outcome|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
273170|NCT01322022|O1|Outcome|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
273171|NCT01322022|O2|Outcome|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
273172|NCT01322022|O1|Outcome|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
273173|NCT01322022|O2|Outcome|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
273174|NCT01322022|O1|Outcome|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
273175|NCT01322022|O2|Outcome|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
273176|NCT01322022|O1|Outcome|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
273177|NCT01322022|E2|Reported Event|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
273178|NCT01322022|E1|Reported Event|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
273179|NCT01322009|B3|Baseline|Total|Total of all reporting groups
273180|NCT01322009|B2|Baseline|Placebo|"Placebos will be prepared for the two experimental drugs and administered at identical time periods.~Placebo: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days. Placebo contents include equal volumes and dosing regimens of lactose powder (for opacity) suspended in Ora-Plus and normal saline."
273181|NCT01322009|B1|Baseline|Drug|"Probenecid and N-acetyl cysteine will be administered at standard doses for the first 4 days after TBI.~Probenecid and N-acetyl cysteine: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days or to receive placebos."
273182|NCT01322009|P2|Participant Flow|Placebo|"Placebos will be prepared for the two experimental drugs and administered at identical time periods.~Placebo: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days. Placebo contents include equal volumes and dosing regimens of lactose powder (for opacity) suspended in Ora-Plus and normal saline."
273183|NCT01322009|P1|Participant Flow|Drug|"Probenecid and N-acetyl cysteine will be administered at standard doses for the first 4 days after TBI.~Probenecid and N-acetyl cysteine: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days or to receive placebos."
273184|NCT01322009|O2|Outcome|Placebo|"Placebos will be prepared for the two experimental drugs and administered at identical time periods.~Placebo: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days. Placebo contents include equal volumes and dosing regimens of lactose powder (for opacity) suspended in Ora-Plus and normal saline."
273185|NCT01322009|O1|Outcome|Drug|"Probenecid and N-acetyl cysteine will be administered at standard doses for the first 4 days after TBI.~Probenecid and N-acetyl cysteine: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days or to receive placebos."
273186|NCT01322009|O2|Outcome|Placebo|"Placebos will be prepared for the two experimental drugs and administered at identical time periods.~Placebo: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days. Placebo contents include equal volumes and dosing regimens of lactose powder (for opacity) suspended in Ora-Plus and normal saline."
273187|NCT01322009|O1|Outcome|Drug|"Probenecid and N-acetyl cysteine will be administered at standard doses for the first 4 days after TBI.~Probenecid and N-acetyl cysteine: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days or to receive placebos."
273188|NCT01322009|E2|Reported Event|Placebo|"Placebos will be prepared for the two experimental drugs and administered at identical time periods.~Placebo: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days. Placebo contents include equal volumes and dosing regimens of lactose powder (for opacity) suspended in Ora-Plus and normal saline."
273189|NCT01322009|E1|Reported Event|Drug|"Probenecid and N-acetyl cysteine will be administered at standard doses for the first 4 days after TBI.~Probenecid and N-acetyl cysteine: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days or to receive placebos."
273190|NCT01321749|B3|Baseline|Total|Total of all reporting groups
273191|NCT01321749|B2|Baseline|Stroke Secondary Prevention|Procedure:stroke secondary prevention
273192|NCT01321749|B1|Baseline|RIPC+Stroke Secondary Prevension|"Procedure/Surgery: RIPC The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.~Procedure:stroke secondary prevention"
273193|NCT01321749|P2|Participant Flow|Stroke Secondary Prevention|Procedure:stroke secondary prevention
273194|NCT01321749|P1|Participant Flow|RIPC+Stroke Secondary Prevension|"Procedure/Surgery: RIPC The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.~Procedure:stroke secondary prevention"
273195|NCT01321749|O2|Outcome|Stroke Secondary Prevention|Procedure:stroke secondary prevention
273340|NCT01320722|O3|Outcome|Probenecid|Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
273196|NCT01321749|O1|Outcome|RIPC+Stroke Secondary Prevension|"Procedure/Surgery: RIPC The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.~Procedure:stroke secondary prevention"
273197|NCT01321749|E2|Reported Event|Stroke Secondary Prevention|Procedure:stroke secondary prevention
273198|NCT01321749|E1|Reported Event|RIPC+Stroke Secondary Prevension|"Procedure/Surgery: RIPC The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.~Procedure:stroke secondary prevention"
273199|NCT01321723|B4|Baseline|Total|Total of all reporting groups
273200|NCT01321723|B3|Baseline|Placebo|Placebo : matching tablets, once daily
273201|NCT01321723|B2|Baseline|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
273202|NCT01321723|B1|Baseline|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
273203|NCT01321723|P3|Participant Flow|Placebo|Placebo : matching tablets, once daily
273204|NCT01321723|P2|Participant Flow|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily.
273205|NCT01321723|P1|Participant Flow|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily.
273206|NCT01321723|O3|Outcome|Placebo|Placebo : matching tablets, once daily
273207|NCT01321723|O2|Outcome|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
273208|NCT01321723|O1|Outcome|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
273209|NCT01321723|O2|Outcome|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
273210|NCT01321723|O1|Outcome|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
273211|NCT01321723|O3|Outcome|Placebo|Placebo : matching tablets, once daily
273212|NCT01321723|O2|Outcome|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
273213|NCT01321723|O1|Outcome|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
273214|NCT01321723|O3|Outcome|Placebo|Placebo : matching tablets, once daily
273215|NCT01321723|O2|Outcome|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
273216|NCT01321723|O1|Outcome|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
273217|NCT01321723|O3|Outcome|Placebo|Placebo : matching tablets, once daily
273218|NCT01321723|O2|Outcome|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
273219|NCT01321723|O1|Outcome|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
273220|NCT01321723|E3|Reported Event|Placebo|Placebo : matching tablets, once daily
273221|NCT01321723|E2|Reported Event|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
273222|NCT01321723|E1|Reported Event|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
273223|NCT01321710|B4|Baseline|Total|Total of all reporting groups
273224|NCT01321710|B3|Baseline|Sleep Hygiene & Acetaminophen|"Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep.~Infants in this arm receive an acetaminophen intervention to minimize sleep disturbance following immunization."
273225|NCT01321710|B2|Baseline|Sleep Hygiene & Standard Care|"Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep.~Infants in this arm receive standard immunization care."
273226|NCT01321710|B1|Baseline|Dietary Information & Standard Care|"Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.~Infants in this arm receive standard immunization care."
273227|NCT01321710|P3|Participant Flow|Sleep Hygiene & Acetaminophen|"Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep.~Infants in this arm receive an acetaminophen intervention to minimize sleep disturbance following immunization."
273228|NCT01321710|P2|Participant Flow|Sleep Hygiene & Standard Care|"Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep.~Infants in this arm receive standard immunization care."
273229|NCT01321710|P1|Participant Flow|Dietary Information & Standard Care|"Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.~Infants in this arm receive standard immunization care."
273230|NCT01321710|O2|Outcome|Prophylactic Acetaminophen|Infants in this group received prophylactic acetaminophen administered prior to immunization and 4 subsequent doses administered in the 24 hours following immunization.
273231|NCT01321710|O1|Outcome|Standard Immunization Care|Infants in this group received standard immunization care from their health care provider (may or may not have included prophylactic acetaminophen).
273232|NCT01321710|O2|Outcome|Sleep Hygiene|Mothers in this group received sleep hygiene information.
273233|NCT01321710|O1|Outcome|Dietary Information|Mothers in this group received dietary information for improving sleep.
273234|NCT01321710|O2|Outcome|Sleep Hygiene|Mothers in this group received sleep hygiene information.
273235|NCT01321710|O1|Outcome|Dietary Information|Mothers in this group received dietary information for improving sleep.
273236|NCT01321710|O2|Outcome|Sleep Hygiene|Mothers in this group received sleep hygiene information
273237|NCT01321710|O1|Outcome|Dietary Information|Mothers in this group received dietary information for improving sleep.
273238|NCT01321710|O2|Outcome|Sleep Hygiene|Mothers in this group received sleep hygiene information
273239|NCT01321710|O1|Outcome|Dietary Information|Mothers in this group received dietary information for improving sleep.
273240|NCT01321710|E3|Reported Event|Sleep Hygiene & Acetaminophen|"Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep.~Infants in this arm receive an acetaminophen intervention to minimize sleep disturbance following immunization."
273241|NCT01321710|E2|Reported Event|Sleep Hygiene & Standard Care|"Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep.~Infants in this arm receive standard immunization care."
273242|NCT01321710|E1|Reported Event|Dietary Information & Standard Care|"Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.~Infants in this arm receive standard immunization care."
273341|NCT01320722|O2|Outcome|Placebo- Vitamin D|Placebo soft gel once per week for 8 weeks.
301640|NCT01242514|E3|Reported Event|FOSTA 150 MG QD|
273243|NCT01321697|B1|Baseline|Vulvar Cancer|Routine Leg edema and groin dissection : The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.
273244|NCT01321697|P1|Participant Flow|Vulvar Cancer|Routine Leg edema and groin dissection : The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.
273245|NCT01321697|O1|Outcome|Vulvar Cancer|Routine Leg edema and groin dissection : The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.
273246|NCT01321697|E1|Reported Event|Vulvar Cancer|Routine Leg edema and groin dissection : The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.
273247|NCT01321554|B3|Baseline|Total|Total of all reporting groups
273248|NCT01321554|B2|Baseline|Placebo (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
273249|NCT01321554|B1|Baseline|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
273250|NCT01321554|P4|Participant Flow|Lenvatinib 20 mg (OOL Lenvatinib Treatment Period)|Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib. The starting dose of lenvatinib during the OOL Lenvatinib Treatment Period was 24 mg once daily from 03 Oct 2011 until 15 Feb 2013. The starting dose was lowered at the request of the Data Monitoring Committee to 20mg on 16 Feb 2013.
273251|NCT01321554|P3|Participant Flow|Lenvatinib 24 mg (OOL Lenvatinib Treatment Period)|Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib
273252|NCT01321554|P2|Participant Flow|Placebo (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
273253|NCT01321554|P1|Participant Flow|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
273254|NCT01321554|O1|Outcome|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
273255|NCT01321554|O2|Outcome|Placebo (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
273256|NCT01321554|O1|Outcome|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
273257|NCT01321554|O2|Outcome|Placebo (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
273258|NCT01321554|O1|Outcome|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
273259|NCT01321554|O2|Outcome|Placebo (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
273260|NCT01321554|O1|Outcome|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
273261|NCT01321554|E4|Reported Event|Lenvatinib 20 mg (OOL Lenvatinib Treatment Period)|Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib. The starting dose of lenvatinib during the OOL Lenvatinib Treatment Period was 24 mg once daily from 03 Oct 2011 until 15 Feb 2013. The starting dose was lowered at the request of the Data Monitoring Committee to 20 mg on 16 Feb 2013.
273262|NCT01321554|E3|Reported Event|Lenvatinib 24 mg (OOL Lenvatinib Treatment Period)|Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib
273263|NCT01321554|E2|Reported Event|Placebo (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
273264|NCT01321554|E1|Reported Event|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
273265|NCT01321073|B1|Baseline|DelIVery for Pulmonary Arterial Hypertension Single Arm|"All subjects were enrolled for implantation of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection.~Model 10642 Implantable Intravascular Catheter: This clinical study consists of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection. This study will focus on the safety of delivery of Remodulin Injection in the treatment of patients with PAH who meet the approved Remodulin Injection indication, using the approved formulation, and approved intravenous route of administration."
273342|NCT01320722|O1|Outcome|Vitamin D|Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
273401|NCT01320293|O1|Outcome|Adalimumab|"active~Adalimumab: 40mg subcutaneously, every other week for 6 months"
273266|NCT01321073|P1|Participant Flow|DelIVery for Pulmonary Arterial Hypertension Single Arm|"All subjects were enrolled for implantation of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection.~Model 10642 Implantable Intravascular Catheter: This clinical study consists of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection. This study will focus on the safety of delivery of Remodulin Injection in the treatment of patients with PAH who meet the approved Remodulin Injection indication, using the approved formulation, and approved intravenous route of administration."
273267|NCT01321073|O1|Outcome|DelIVery for Pulmonary Arterial Hypertension Single Arm|"All subjects were enrolled for implantation of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection.~Model 10642 Implantable Intravascular Catheter: This clinical study consists of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection. This study will focus on the safety of delivery of Remodulin Injection in the treatment of patients with PAH who meet the approved Remodulin Injection indication, using the approved formulation, and approved intravenous route of administration."
273268|NCT01321073|E1|Reported Event|Single Arm|"All subjects were enrolled for implantation of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection.~Model 10642 Implantable Intravascular Catheter: This clinical study consists of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection. This study will focus on the safety of delivery of Remodulin Injection in the treatment of patients with PAH who meet the approved Remodulin Injection indication, using the approved formulation, and approved intravenous route of administration."
273269|NCT01321008|B1|Baseline|Radiation + Chemotherapy|Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
273270|NCT01321008|P1|Participant Flow|Radiation + Chemotherapy|Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
273271|NCT01321008|O1|Outcome|Radiation + Chemotherapy|Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
273272|NCT01321008|E1|Reported Event|Radiation + Chemotherapy|Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
273273|NCT01320943|B3|Baseline|Total|Total of all reporting groups
273274|NCT01320943|B2|Baseline|Continue TDF|Participants continued TDF monotherapy 300 mg once daily.
273275|NCT01320943|B1|Baseline|Stop TDF|Participants stopped tenofovir disoproxil fumarate (Viread®; TDF) monotherapy at baseline.
273276|NCT01320943|P2|Participant Flow|Continue TDF|Participants continued TDF monotherapy 300 mg once daily.
273277|NCT01320943|P1|Participant Flow|Stop TDF|Participants stopped tenofovir disoproxil fumarate (Viread®; TDF) monotherapy at baseline.
273278|NCT01320943|O2|Outcome|Continue TDF|Participants continued TDF monotherapy 300 mg once daily.
273279|NCT01320943|O1|Outcome|Stop TDF|Participants stopped TDF monotherapy at baseline.
273280|NCT01320943|O2|Outcome|Re-Start TDF|Stop TDF participants who restarted TDF therapy
273281|NCT01320943|O1|Outcome|Stop TDF (TDF-Free)|Participants who stopped TDF monotherapy at baseline. Participants in this group were TDF free.
273282|NCT01320943|O2|Outcome|Re-Start TDF|Stop TDF participants who restarted TDF therapy
273283|NCT01320943|O1|Outcome|Stop TDF (TDF-Free)|Participants stopped TDF monotherapy at baseline. Participants in this group were TDF free.
273284|NCT01320943|O1|Outcome|Stop TDF|Participants stopped TDF monotherapy at baseline.
273285|NCT01320943|O3|Outcome|Continue TDF|Participants who continued TDF monotherapy 300 mg once daily.
273286|NCT01320943|O2|Outcome|Restart TDF|Stop TDF participants who restarted TDF therapy
273287|NCT01320943|O1|Outcome|Stop TDF (TDF-Free)|Participants who stopped TDF monotherapy at baseline. Participants in this group were TDF free.
273288|NCT01320943|O2|Outcome|Continue TDF|Participants continued TDF monotherapy 300 mg once daily.
273289|NCT01320943|O1|Outcome|Stop TDF|Participants stopped tenofovir disoproxil fumarate monotherapy at baseline.
273290|NCT01320943|O2|Outcome|Continue TDF|Participants continued TDF monotherapy 300 mg once daily.
273291|NCT01320943|O1|Outcome|Stop TDF|Participants stopped tenofovir disoproxil fumarate monotherapy at baseline.
273292|NCT01320943|E3|Reported Event|Continue TDF [TDF Emergent]|Participants continued TDF monotherapy 300 mg once daily.
273293|NCT01320943|E2|Reported Event|Re-start TDF [TDF Emergent]|Stop TDF participants who restarted TDF therapy.
273294|NCT01320943|E1|Reported Event|Stop TDF (TDF-Free) [Termination Emergent]|Participants stopped TDF monotherapy at baseline.
273295|NCT01320826|B1|Baseline|Participants.|All patients having a colonoscopy done by an APC-Endo study physician endoscopist were approached at the time of their endoscopy to consent to the post procedure telephone survey.
273296|NCT01320826|P1|Participant Flow|Patients Undergoing Colonoscopy|All patients having a colonoscopy done by an APC-Endo study physician endoscopist were approached at the time of their endoscopy to consent to the post procedure telephone survey.
273297|NCT01320826|O1|Outcome|Percentage of Females ≥ 50 Years With an Adenoma|"Percentage of patients with an adenoma = (number of patients who had at least one adenoma detected on colonoscopy / total number of colonoscopies attempted) x 100.~For this specific outcome: we explored this outcome for females 50 years and older undergoing first time colonoscopy."
273402|NCT01320293|O1|Outcome|Adalimumab|"active~Adalimumab: 40mg subcutaneously, every other week for 6 months"
273298|NCT01320826|O1|Outcome|Percentage of Patients Referred to a Specialist.|The percentage of patients who, after having a colonoscopy, are referred to another specialist for their gastrointestinal problem. A specialist was defined as a physician more specialized than the person performing the colonoscopy, and a referral was counted if the physician, at the time of colonoscopy, sent or anticipated sending the patient to a specialist for any reason, or if the patient believed they were being sent to a specialist.
273299|NCT01320826|O1|Outcome|Procedural Time|Procedural time was defined as the time from the first insertion of the colonoscope until it was removed from the anus, in minutes
273300|NCT01320826|O1|Outcome|Patient Satisfaction With Hospital Experience|Patient satisfaction with hospital experience measured on 7 point Likert scale. 7 is extremely satisfied, 1 is extremely dissatisfied.
273301|NCT01320826|O1|Outcome|Patient Wait Time Satisfaction|"Patient satisfaction with endoscopy wait time will be recorded using a 7 point Likert scale at the time of the patient phone survey. 7 is extremely satisfied and 1 is extremely dissatisfied~minimum score = 1 maximum score = 7"
273302|NCT01320826|O1|Outcome|Patient Comfort During Colonoscopy|Patient discomfort on 5 point scale 0 is no discomfort; 1 is one or two episodes of discomfort, well tolerated; 2 is more than two episodes of discomfort adequately tolerated; 3 is significant discomfort experienced several times during the procedure; 4 is extreme discomfort experienced frequency throughout the procedure.
273303|NCT01320826|O1|Outcome|Withdraw Times, Minutes|
273304|NCT01320826|O1|Outcome|Colonoscopy Complications|"Potential serious complications of colonoscopy include bleeding, perforation, cardiopulmonary complications secondary to conscious sedation and death.~Potential serious complications will be determined from the case report form (physician reported) and at patient satisfaction phone survey (on average four weeks after colonoscopy).~All potential serious complications of colonoscopy will be externally adjudicated."
273305|NCT01320826|O1|Outcome|Percentage of Males 50 Years and Older Undergoing First Time c|"Percentage of patients with an adenoma = (number of patients who had at least one adenoma detected on colonoscopy / total number of colonoscopies attempted) x 100.~For this specific outcome: we explored this outcome for males 50 years and older undergoing first time colonoscopy."
273306|NCT01320826|O1|Outcome|Adenoma Detection Ratio|The adenoma detection ratio is the number of pathologically verified adenomas per number of colonoscopies performed. Adenoma detection ratio = total number of pathologically confirmed adenomas / number of colonoscopies attempted.
273307|NCT01320826|O1|Outcome|Percentage of Successful Cecal Intubations|The percentage of successful cecal intubations (adjusted) = total number of colonoscopies performed where cecal intubation was achieved / (total number of colonoscopies attempted -incomplete colonoscopies due to poor bowel preparation, colonic stricture, equipment failure or severe endoscopic colitis)
273308|NCT01320826|O1|Outcome|Percentage of Successful Cecal Intubations (Crude)|The percentage of successful cecal intubations (crude) = (total # of colonoscopies performed where cecal intubation was achieved / total # of colonoscopies attempted) x 100
273309|NCT01320826|E1|Reported Event|Participants.|All patients having a colonoscopy done by an APC-Endo study physician endoscopist were approached at the time of their endoscopy to consent to the post procedure telephone survey.
273310|NCT01320735|B1|Baseline|Advanced PCa|Participants with advanced PCa
273311|NCT01320735|P1|Participant Flow|Advanced Prostate Cancer (PCa)|Participants with advanced PCa
273312|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
273313|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
273314|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
273315|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
273316|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
273317|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
273318|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
273319|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
273320|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
273321|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
273322|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
273323|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
273324|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
273325|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
273326|NCT01320735|E1|Reported Event|Advanced PCa|Participants with advanced PCa
273327|NCT01320722|B6|Baseline|Total|Total of all reporting groups
273328|NCT01320722|B5|Baseline|Placebo- Uric Acid|Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
273329|NCT01320722|B4|Baseline|Allopurinol|Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
273330|NCT01320722|B3|Baseline|Probenecid|Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
273331|NCT01320722|B2|Baseline|Placebo- Vitamin D|Placebo soft gel once per week for 8 weeks.
273332|NCT01320722|B1|Baseline|Vitamin D|Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
273333|NCT01320722|P5|Participant Flow|Placebo- Uric Acid|Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
273334|NCT01320722|P4|Participant Flow|Allopurinol|Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
273335|NCT01320722|P3|Participant Flow|Probenecid|Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
273336|NCT01320722|P2|Participant Flow|Placebo- Vitamin D|Placebo soft gel once per week for 8 weeks.
273337|NCT01320722|P1|Participant Flow|Vitamin D|Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
273338|NCT01320722|O5|Outcome|Placebo- Uric Acid|Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
273339|NCT01320722|O4|Outcome|Allopurinol|Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
301641|NCT01242514|E2|Reported Event|FOSTA 100 MG QD|
273343|NCT01320722|O5|Outcome|Placebo- Uric Acid|Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
273344|NCT01320722|O4|Outcome|Allopurinol|Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
273345|NCT01320722|O3|Outcome|Probenecid|Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
273346|NCT01320722|O2|Outcome|Placebo- Vitamin D|Placebo soft gel once per week for 8 weeks.
273347|NCT01320722|O1|Outcome|Vitamin D|Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
273348|NCT01320722|O5|Outcome|Placebo- Uric Acid|Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
273349|NCT01320722|O4|Outcome|Allopurinol|Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
273350|NCT01320722|O3|Outcome|Probenecid|Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
273351|NCT01320722|O2|Outcome|Placebo- Vitamin D|Placebo soft gel once per week for 8 weeks.
273352|NCT01320722|O1|Outcome|Vitamin D|Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
273353|NCT01320722|O3|Outcome|Placebo- Uric Acid|Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
273354|NCT01320722|O2|Outcome|Allopurinol|Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
273355|NCT01320722|O1|Outcome|Probenecid|Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
273356|NCT01320722|O3|Outcome|Placebo- Uric Acid|Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
273357|NCT01320722|O2|Outcome|Allopurinol|Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
273358|NCT01320722|O1|Outcome|Probenecid|Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
273359|NCT01320722|O3|Outcome|Placebo- Uric Acid|Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
273360|NCT01320722|O2|Outcome|Allopurinol|Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
273361|NCT01320722|O1|Outcome|Probenecid|Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
273362|NCT01320722|O2|Outcome|Placebo- Vitamin D|Placebo soft gel once per week for 8 weeks.
273363|NCT01320722|O1|Outcome|Vitamin D|Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
273364|NCT01320722|O2|Outcome|Placebo- Vitamin D|Placebo soft gel once per week for 8 weeks.
273365|NCT01320722|O1|Outcome|Vitamin D|Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
273366|NCT01320722|O2|Outcome|Placebo- Vitamin D|Placebo soft gel once per week for 8 weeks.
273367|NCT01320722|O1|Outcome|Vitamin D|Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
273368|NCT01320722|E5|Reported Event|Placebo- Uric Acid|Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
273369|NCT01320722|E4|Reported Event|Allopurinol|Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
273370|NCT01320722|E3|Reported Event|Probenecid|Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
273371|NCT01320722|E2|Reported Event|Placebo- Vitamin D|Placebo soft gel once per week for 8 weeks.
273372|NCT01320722|E1|Reported Event|Vitamin D|Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
273373|NCT01320683|B1|Baseline|Treatment (Combination Chemotherapy and Radioimmunotherapy)|FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
273374|NCT01320683|P1|Participant Flow|Treatment (Combination Chemotherapy and Radioimmunotherapy)|FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
273398|NCT01320553|E1|Reported Event|1334 H 0.15%|"1334H 0.15% eye drops will be administered in both eyes at 3 occasions~1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions"
273399|NCT01320293|B1|Baseline|Adalimumab|"active~Adalimumab: 40mg subcutaneously, every other week for 6 months"
273400|NCT01320293|P1|Participant Flow|Adalimumab|"active~Adalimumab: 40mg subcutaneously, every other week for 6 months"
301642|NCT01242514|E1|Reported Event|FOSTA 100 MG BID|
273375|NCT01320683|O1|Outcome|Treatment (Combination Chemotherapy and Radioimmunotherapy)|FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
273376|NCT01320683|O1|Outcome|Treatment (Combination Chemotherapy and Radioimmunotherapy)|FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
273377|NCT01320683|E1|Reported Event|Treatment (Combination Chemotherapy and Radioimmunotherapy)|FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
273378|NCT01320553|B5|Baseline|Total|Total of all reporting groups
273379|NCT01320553|B4|Baseline|Placebo|"Placebo eye drops (solution)will be administered in both eyes at 3 occasions~Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions"
273380|NCT01320553|B3|Baseline|1334 H-0.45%|"1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions~1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions"
273381|NCT01320553|B2|Baseline|1334 H-0.3%|"1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions~1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions"
273382|NCT01320553|B1|Baseline|1334 H 0.15%|"1334H 0.15% eye drops will be administered in both eyes at 3 occasions~1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions"
273383|NCT01320553|P4|Participant Flow|Vehicle|"Vehicle eye drops (solution)will be administered in both eyes at 3 occasions~Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions"
273384|NCT01320553|P3|Participant Flow|1334 H-0.45%|"1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions~1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions"
273385|NCT01320553|P2|Participant Flow|1334 H-0.3%|"1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions~1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions"
273386|NCT01320553|P1|Participant Flow|1334 H 0.15%|"1334H 0.15% eye drops will be administered in both eyes at 3 occasions~1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions"
273387|NCT01320553|O4|Outcome|Vehicle|"Vehicle eye drops (solution)will be administered in both eyes at 3 occasions~Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions"
273388|NCT01320553|O3|Outcome|1334 H-0.45%|"1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions~1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions"
273389|NCT01320553|O2|Outcome|1334 H-0.3%|"1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions~1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions"
273390|NCT01320553|O1|Outcome|1334 H 0.15%|"1334H 0.15% eye drops will be administered in both eyes at 3 occasions~1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions"
273391|NCT01320553|O4|Outcome|Vehicle|"Vehicle eye drops (solution)will be administered in both eyes at 3 occasions~Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions"
273392|NCT01320553|O3|Outcome|1334 H-0.45%|"1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions~1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions"
273393|NCT01320553|O2|Outcome|1334 H-0.3%|"1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions~1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions"
273394|NCT01320553|O1|Outcome|1334 H 0.15%|"1334H 0.15% eye drops will be administered in both eyes at 3 occasions~1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions"
273395|NCT01320553|E4|Reported Event|Vehicle|"Vehicle eye drops (solution)will be administered in both eyes at 3 occasions~Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions"
273396|NCT01320553|E3|Reported Event|1334 H-0.45%|"1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions~1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions"
273397|NCT01320553|E2|Reported Event|1334 H-0.3%|"1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions~1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions"
301643|NCT01242371|B3|Baseline|Total|Total of all reporting groups
273403|NCT01320293|O1|Outcome|Adalimumab|"active~Adalimumab: 40mg subcutaneously, every other week for 6 months"
273404|NCT01320293|E1|Reported Event|Adalimumab|"active~Adalimumab: 40mg subcutaneously, every other week for 6 months"
273405|NCT01320202|B3|Baseline|Total|Total of all reporting groups
273406|NCT01320202|B2|Baseline|Standard Dialysate|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 18 months."
273407|NCT01320202|B1|Baseline|Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 18 months."
273408|NCT01320202|P2|Participant Flow|Standard Dialysate|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
273409|NCT01320202|P1|Participant Flow|Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
273410|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
273411|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
273412|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
273413|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
273414|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
273415|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
273416|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
273417|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
273418|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
273419|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
273420|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
273421|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
273422|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
273423|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
273424|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
273425|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
273426|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
273427|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
273428|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
273429|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
273468|NCT01320072|E2|Reported Event|Aspirin-tolerant Asthmatics|Aspirin tolerant asthma patients, N=13
273430|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
273431|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
273432|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
273433|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
273434|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
273435|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
273436|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
273437|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
273438|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
273439|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
273440|NCT01320202|E3|Reported Event|Stage 3 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Upon completion of Stage 2, patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 3 for up to 72 weeks of total study participation (Stage 2 + Stage 3)."
273441|NCT01320202|E2|Reported Event|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks."
273442|NCT01320202|E1|Reported Event|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks."
273443|NCT01320137|B3|Baseline|Total|Total of all reporting groups
273444|NCT01320137|B2|Baseline|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
273445|NCT01320137|B1|Baseline|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
273446|NCT01320137|P2|Participant Flow|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
273447|NCT01320137|P1|Participant Flow|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
273448|NCT01320137|O2|Outcome|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
273449|NCT01320137|O1|Outcome|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
273450|NCT01320137|O2|Outcome|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
273451|NCT01320137|O1|Outcome|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
273452|NCT01320137|O2|Outcome|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
273453|NCT01320137|O1|Outcome|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
273454|NCT01320137|O2|Outcome|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
273455|NCT01320137|O1|Outcome|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
273456|NCT01320137|E2|Reported Event|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
273457|NCT01320137|E1|Reported Event|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
273458|NCT01320072|B3|Baseline|Total|Total of all reporting groups
273459|NCT01320072|B2|Baseline|Aspirin-tolerant Asthmatics|aspirin-tolerant patients with asthma
273460|NCT01320072|B1|Baseline|Aspirin-sensitive Asthmatics|patients with aspirin exacerbated respiratory disease
273461|NCT01320072|P2|Participant Flow|Aspirin-tolerant Asthmatics|Aspirin tolerant asthma patients, N=13
273462|NCT01320072|P1|Participant Flow|Aspirin-sensitive Asthmatics|Patients with aspirin exacerbated respiratory disease, N=16
273463|NCT01320072|O1|Outcome|Aspirin-sensitive Asthmatics|Asthma patients with aspirin exacerbated respiratory disease
273464|NCT01320072|O2|Outcome|Aspirin-tolerant Asthmatics|Aspirin tolerant asthma patients, N=13
273465|NCT01320072|O1|Outcome|Aspirin-sensitive Asthmatics|Patients with aspirin exacerbated respiratory disease, N=16
273466|NCT01320072|O2|Outcome|Aspirin-tolerant Asthmatics|Aspirin tolerant asthma patients, N=13
273467|NCT01320072|O1|Outcome|Aspirin-sensitive Asthmatics|Patients with aspirin exacerbated respiratory disease, N=16
306234|NCT01229228|B2|Baseline|Naproxen Test (Upper Dose)|
273469|NCT01320072|E1|Reported Event|Aspirin-sensitive Asthmatics|Patients with aspirin exacerbated respiratory disease, N=16
273470|NCT01319877|B3|Baseline|Total|Total of all reporting groups
273471|NCT01319877|B2|Baseline|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
273472|NCT01319877|B1|Baseline|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
273473|NCT01319877|P2|Participant Flow|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
273474|NCT01319877|P1|Participant Flow|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
273475|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
273476|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
273477|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
273478|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
273479|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
273480|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
273481|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
273482|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
273483|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
273484|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
273485|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
273486|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
273487|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
273488|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
273489|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
273490|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
273491|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
273492|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
273493|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
273494|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
273495|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
273496|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
273497|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
273498|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
273499|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
273500|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
273501|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
273502|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
273503|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
273504|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
273505|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
273506|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
273507|NCT01319877|E1|Reported Event|First and Second Line Treatment|The participants from the first line and second line treatments were combined for the adverse event analysis.
273508|NCT01319851|B1|Baseline|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
273509|NCT01319851|P1|Participant Flow|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
273510|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
273511|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
273512|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
273513|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
273514|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
273515|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
273516|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
273517|NCT01319851|E1|Reported Event|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
273518|NCT01319812|B3|Baseline|Total|Total of all reporting groups
273519|NCT01319812|B2|Baseline|Pulsar Stent Group|Subjects implanted with an Astron Pulsar or Pulsar-18 stent.
273520|NCT01319812|B1|Baseline|Astron Stent Group|Subjects implanted with an Astron stent.
273521|NCT01319812|P2|Participant Flow|Pulsar Stent Group|Subjects implanted with an Astron Pulsar or Pulsar-18 stent.
273522|NCT01319812|P1|Participant Flow|Astron Stent Group|Subjects implanted with an Astron stent.
273523|NCT01319812|O2|Outcome|Pulsar Stent Group - Long Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
273524|NCT01319812|O1|Outcome|Pulsar Stent Group - Standard Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
273525|NCT01319812|O2|Outcome|Pulsar Stent Group - Long Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
273526|NCT01319812|O1|Outcome|Pulsar Stent Group - Standard Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
273527|NCT01319812|O2|Outcome|Pulsar Stent Group - Long Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
273528|NCT01319812|O1|Outcome|Pulsar Stent Group - Standard Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
273529|NCT01319812|O2|Outcome|Pulsar Stent Group - Long Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
273530|NCT01319812|O1|Outcome|Pulsar Stent Group - Standard Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
273531|NCT01319812|O2|Outcome|Pulsar Stent Group - Long Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
273532|NCT01319812|O1|Outcome|Pulsar Stent Group - Standard Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
273533|NCT01319812|O2|Outcome|Pulsar Stent Group - Long Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
273534|NCT01319812|O1|Outcome|Pulsar Stent Group - Standard Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
273535|NCT01319812|O2|Outcome|Pulsar Stent Group - Long Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
273536|NCT01319812|O1|Outcome|Pulsar Stent Group - Standard Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
273537|NCT01319812|O4|Outcome|Pulsar Stent Group - Non-occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
273538|NCT01319812|O3|Outcome|Pulsar Stent Group - Occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
273539|NCT01319812|O2|Outcome|Astron Stent Group - Non-occlusive|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
273540|NCT01319812|O1|Outcome|Astron Stent Group - Occlusive Lesion|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
273541|NCT01319812|O4|Outcome|Pulsar Stent Group - Non-occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
273542|NCT01319812|O3|Outcome|Pulsar Stent Group - Occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
273583|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
273543|NCT01319812|O2|Outcome|Astron Stent Group - Non-occlusive|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
273544|NCT01319812|O1|Outcome|Astron Stent Group - Occlusive Lesion|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
273545|NCT01319812|O4|Outcome|Pulsar Stent Group - Non-occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
273546|NCT01319812|O3|Outcome|Pulsar Stent Group - Occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
273547|NCT01319812|O2|Outcome|Astron Stent Group - Non-occlusive|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
273548|NCT01319812|O1|Outcome|Astron Stent Group - Occlusive Lesion|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
273549|NCT01319812|O4|Outcome|Pulsar Stent Group - Non-occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
273550|NCT01319812|O3|Outcome|Pulsar Stent Group - Occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
273551|NCT01319812|O2|Outcome|Astron Stent Group - Non-occlusive|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
273552|NCT01319812|O1|Outcome|Astron Stent Group - Occlusive Lesion|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
273553|NCT01319812|O4|Outcome|Pulsar Stent Group - Non-occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
273554|NCT01319812|O3|Outcome|Pulsar Stent Group - Occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
273555|NCT01319812|O2|Outcome|Astron Stent Group - Non-occlusive|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
273556|NCT01319812|O1|Outcome|Astron Stent Group - Occlusive Lesion|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
273557|NCT01319812|O4|Outcome|Pulsar Stent Group - Non-occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
273558|NCT01319812|O3|Outcome|Pulsar Stent Group - Occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
273559|NCT01319812|O2|Outcome|Astron Stent Group - Non-occlusive|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
273560|NCT01319812|O1|Outcome|Astron Stent Group - Occlusive Lesion|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
273561|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
273562|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
273563|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
273564|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
273565|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
273566|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
273567|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
273568|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
273569|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
273570|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
273571|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
273572|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
273573|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
273574|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
273575|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
273576|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
273577|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
273578|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
273579|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
273580|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
273581|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
273582|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
274443|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
273584|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
273585|NCT01319812|O1|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
273586|NCT01319812|O1|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
273587|NCT01319812|O1|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
273588|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
273589|NCT01319812|O1|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
273590|NCT01319812|O1|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
273591|NCT01319812|E2|Reported Event|Pulsar Stent Group|Subjects indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
273592|NCT01319812|E1|Reported Event|Astron Stent Group|Subjects indicated for stenting in iliac atherosclerotic lesions.
273593|NCT01319799|B1|Baseline|Surgical Aortic Valve Replacement|Open heart surgery : TCD count of microembolic signals during surgical aortic valve replacement
273594|NCT01319799|P1|Participant Flow|Surgical Aortic Valve Replacement|Open heart surgery : TCD count of microembolic signals during surgical aortic valve replacement
273595|NCT01319799|O1|Outcome|Surgical Aortic Valve Replacement|Open heart surgery : TCD count of microembolic signals during surgical aortic valve replacement
273596|NCT01319799|O1|Outcome|Surgical Aortic Valve Replacement|Open heart surgery : TCD count of microembolic signals during surgical aortic valve replacement
273597|NCT01319799|E1|Reported Event|Surgical Aortic Valve Replacement|Open heart surgery : TCD count of microembolic signals during surgical aortic valve replacement
273598|NCT01319773|B6|Baseline|Total|Total of all reporting groups
273599|NCT01319773|B5|Baseline|PEP: Cyclosporine Formulation A and Cyclosporine Formulation B|PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B
273600|NCT01319773|B4|Baseline|PEP: Cyclosporine Formulation B and Cyclosporine 0.05%|PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05%
273601|NCT01319773|B3|Baseline|PEP: Cyclosporine Formulation A and Cyclosporine 0.05%|Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05%
273602|NCT01319773|B2|Baseline|PGP: Cyclosporine Formulation B|PGP: cyclosporine ophthalmic emulsion Formulation B
273603|NCT01319773|B1|Baseline|PGP: Cyclosporine Formulation A|Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A
273604|NCT01319773|P5|Participant Flow|PEP: Cyclosporine Formulation A and Cyclosporine Formulation B|PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B
273605|NCT01319773|P4|Participant Flow|PEP: Cyclosporine Formulation B and Cyclosporine 0.05%|PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05%
273606|NCT01319773|P3|Participant Flow|PEP: Cyclosporine Formulation A and Cyclosporine 0.05%|Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05%
273607|NCT01319773|P2|Participant Flow|PGP: Cyclosporine Formulation B|PGP: cyclosporine ophthalmic emulsion Formulation B
273608|NCT01319773|P1|Participant Flow|PGP: Cyclosporine Formulation A|Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A
273609|NCT01319773|O3|Outcome|Cyclosporine 0.05%|
273610|NCT01319773|O2|Outcome|Cyclosporine Formulation B|
273611|NCT01319773|O1|Outcome|Cyclosporine Formulation A|
273612|NCT01319773|O2|Outcome|Cyclosporine Formulation B|
273613|NCT01319773|O1|Outcome|Cyclosporine Formulation A|
273614|NCT01319773|O2|Outcome|Cyclosporine Formulation B|
273615|NCT01319773|O1|Outcome|Cyclosporine Formulation A|
273616|NCT01319773|E5|Reported Event|PEP: Cyclosporine Formulation A and Cyclosporine Formulation B|PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B
273617|NCT01319773|E4|Reported Event|PEP: Cyclosporine Formulation B and Cyclosporine 0.05%|PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05%
273618|NCT01319773|E3|Reported Event|PEP: Cyclosporine Formulation A and Cyclosporine 0.05%|Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05%
273619|NCT01319773|E2|Reported Event|PGP: Cyclosporine Formulation B|PGP: cyclosporine ophthalmic emulsion Formulation B
273620|NCT01319773|E1|Reported Event|PGP: Cyclosporine Formulation A|Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A
273621|NCT01319721|B3|Baseline|Total|Total of all reporting groups
273622|NCT01319721|B2|Baseline|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
273623|NCT01319721|B1|Baseline|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
273624|NCT01319721|P2|Participant Flow|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
273625|NCT01319721|P1|Participant Flow|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
273626|NCT01319721|O2|Outcome|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
273627|NCT01319721|O1|Outcome|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
273628|NCT01319721|O2|Outcome|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
273629|NCT01319721|O1|Outcome|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
273630|NCT01319721|O2|Outcome|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
273631|NCT01319721|O1|Outcome|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
273632|NCT01319721|O2|Outcome|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
273633|NCT01319721|O1|Outcome|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
273634|NCT01319721|O2|Outcome|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
273635|NCT01319721|O1|Outcome|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
273636|NCT01319721|E2|Reported Event|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
273637|NCT01319721|E1|Reported Event|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
273638|NCT01319617|B1|Baseline|SENSIMED Triggerfish|"SENSIMED Triggerfish is a device containing a soft silicone contact lens sensor detecting ocular dimensional changes related to IOP through an integrated strain gauge. The device energy and data transfer between the contact lens sensor and the external recording and data storage unit is done using telemetry.~All study subjects received SENSIMED Triggerfish on one eye for 24 hours at two occasions in ambulatory mode, without restriction of activities apart from those contraindicated by the device instructions for use. The device was installed and removed by the study staff during visits to the study center"
273639|NCT01319617|P1|Participant Flow|SENSIMED Triggerfish|"SENSIMED Triggerfish is a device containing a soft silicone contact lens sensor detecting ocular dimensional changes related to IOP through an integrated strain gauge. The device energy and data transfer between the contact lens sensor and the external recording and data storage unit is done using telemetry.~All study subjects received SENSIMED Triggerfish on one eye for 24 hours at two occasions in ambulatory mode, without restriction of activities apart from those contraindicated by the device instructions for use. The device was installed and removed by the study staff during visits to the study center."
273640|NCT01319617|O1|Outcome|SENSIMED Triggerfish|"SENSIMED Triggerfish is a device containing a soft silicone contact lens sensor detecting ocular dimensional changes related to IOP through an integrated strain gauge. The device energy and data transfer between the contact lens sensor and the external recording and data storage unit is done using telemetry.~All study subjects received SENSIMED Triggerfish on one eye for 24 hours at two occasions in ambulatory mode, without restriction of activities apart from those contraindicated by the device instructions for use. The device was installed and removed by the study staff during visits to the study center"
273641|NCT01319617|E1|Reported Event|SENSIMED Triggerfish|"SENSIMED Triggerfish is a device containing a soft silicone contact lens sensor detecting ocular dimensional changes related to IOP through an integrated strain gauge. The device energy and data transfer between the contact lens sensor and the external recording and data storage unit is done using telemetry.~All study subjects received SENSIMED Triggerfish on one eye for 24 hours at two occasions in ambulatory mode, without restriction of activities apart from those contraindicated by the device instructions for use. The device was installed and removed by the study staff during visits to the study center"
273642|NCT01319552|B1|Baseline|Transfusion|"Fresh transfusion: 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions~1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions Old transfusion: 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions"
273643|NCT01319552|P1|Participant Flow|Transfusion|Fresh transfusion : 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions followed by old transfusion : 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
273644|NCT01319552|O2|Outcome|Old Transfusion|Old transfusion : 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
273645|NCT01319552|O1|Outcome|Fresh Transfusion|Fresh transfusion: 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions
273646|NCT01319552|E1|Reported Event|Transfusion|Fresh transfusion : 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions followed by old transfusion : 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
273647|NCT01319539|B1|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.~Akt Inhibitor MK2206: Given PO~Therapeutic Conventional Surgery: Undergo surgery~Pharmacological Study: Correlative studies~Laboratory Biomarker Analysis: Correlative studies"
273648|NCT01319539|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.~Akt Inhibitor MK2206: Given PO~Therapeutic Conventional Surgery: Undergo surgery~Pharmacological Study: Correlative studies~Laboratory Biomarker Analysis: Correlative studies"
273649|NCT01319539|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.~Akt Inhibitor MK2206: Given PO~Therapeutic Conventional Surgery: Undergo surgery~Pharmacological Study: Correlative studies~Laboratory Biomarker Analysis: Correlative studies"
273650|NCT01319539|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.~Akt Inhibitor MK2206: Given PO~Therapeutic Conventional Surgery: Undergo surgery~Pharmacological Study: Correlative studies~Laboratory Biomarker Analysis: Correlative studies"
273651|NCT01319539|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.~Akt Inhibitor MK2206: Given PO~Therapeutic Conventional Surgery: Undergo surgery~Pharmacological Study: Correlative studies~Laboratory Biomarker Analysis: Correlative studies"
273652|NCT01319539|E3|Reported Event|Treatment (MK2206) Dose Level 90mg|Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.
273653|NCT01319539|E2|Reported Event|Treatment (MK2206) Dose Level 135mg|Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.
273654|NCT01319539|E1|Reported Event|Treatment (MK2206) Dose Level 200mg|Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.
273655|NCT01319500|B3|Baseline|Total|Total of all reporting groups
273656|NCT01319500|B2|Baseline|Other OCs|"Users of OCs except Yasmin (Other OCs)"
273657|NCT01319500|B1|Baseline|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
273658|NCT01319500|P2|Participant Flow|Other OCs|"Users of oral contraceptives (OCs) except Yasmin (Other OCs)"
273659|NCT01319500|P1|Participant Flow|Yasmin|"Users of the drospirenone/ethinylestradiol (DRSP/EE) containing OC Yasmin"
273660|NCT01319500|O5|Outcome|Total|All gynecologists (private and public) and dermatologists
273661|NCT01319500|O4|Outcome|Dermatologists|All dermatologists
273662|NCT01319500|O3|Outcome|Gynecologists (Public Practice Only)|Gynecologists in public practice only
273663|NCT01319500|O2|Outcome|Gynecologists (Private Practice Only)|Gynecologists in private practice only
273664|NCT01319500|O1|Outcome|Gynecologists (All)|All gynecologists (private and public)
273665|NCT01319500|O2|Outcome|Other OCs|"Users of OCs except Yasmin (Other OCs)"
273666|NCT01319500|O1|Outcome|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
273667|NCT01319500|O2|Outcome|Other OCs|"Users of OCs except Yasmin (Other OCs)"
273668|NCT01319500|O1|Outcome|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
273669|NCT01319500|O2|Outcome|Other OCs|"Users of OCs except Yasmin (Other OCs)"
273670|NCT01319500|O1|Outcome|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
273671|NCT01319500|O2|Outcome|Other OCs|"Users of OCs except Yasmin (Other OCs)"
273672|NCT01319500|O1|Outcome|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
273673|NCT01319500|E2|Reported Event|Other OCs|"Users of OCs except Yasmin (Other OCs)"
273674|NCT01319500|E1|Reported Event|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
273675|NCT01319422|B3|Baseline|Total|Total of all reporting groups
273676|NCT01319422|B2|Baseline|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
273677|NCT01319422|B1|Baseline|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
273678|NCT01319422|P2|Participant Flow|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
273679|NCT01319422|P1|Participant Flow|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
273680|NCT01319422|O2|Outcome|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
273681|NCT01319422|O1|Outcome|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
273682|NCT01319422|O2|Outcome|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
273683|NCT01319422|O1|Outcome|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
273684|NCT01319422|O2|Outcome|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
273685|NCT01319422|O1|Outcome|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
273686|NCT01319422|O2|Outcome|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
273687|NCT01319422|O1|Outcome|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
273688|NCT01319422|O2|Outcome|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
273689|NCT01319422|O1|Outcome|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
273690|NCT01319422|E2|Reported Event|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
273691|NCT01319422|E1|Reported Event|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
273692|NCT01319396|B1|Baseline|All Participants|All participants had the difference in indicated breathing rate measured. The 2 devices were the BM07 (device under test) and the Somnoscreen (reference device)
273693|NCT01319396|P1|Participant Flow|All Participants|All participants had the difference in indicated breathing rate measured. The 2 devices were the BM07 (device under test) and the Somnoscreen (reference device)
273694|NCT01319396|O1|Outcome|All Participants|All participants had the difference in indicated breathing rate measured. The 2 devices were the BM07 (device under test) and the Somnoscreen (reference device)
273695|NCT01319396|E1|Reported Event|All Participants|All participants had the difference in indicated breathing rate measured. The 2 devices were the BM07 (device under test) and the Somnoscreen (reference device)
273796|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
273696|NCT01319383|B1|Baseline|Single, Multiple and Interval Dosing Of Vorinostat 400 mg PO|The study was separated into Arms for reporting purposes required in this report. The data representing the eligibility and baseline measures were the same throughout the study and are therefore reported as a composite of the entire study. Vorinostat 400 mg PO was administered in single and multiple doses in both Arm 1 and 2. The entire cohort is described below and representative of all who were enrolled in the study over the 5 year period.
273697|NCT01319383|P2|Participant Flow|Interval Dosing|There are 4 steps in this Arm. Step 1 Baseline leukapheresis (Visit 2) to obtain resting CD4+ T cells for quantitation of resting CD4+ T cell infection (RCI) and resting CD4+ T cell- associated HIV RNA (RCVL). Ex-vivo exposure to measure RCVL responsiveness to Vorinostat. Step 2 involved measurement of in vivo response to single dose of VOR. Step 3 involved 2 doses separated by 48 or 72 hours. In vivo responsiveness measured for optimal dose interval and step advancement. Step 4 measured significance of response to VOR 400 mg PO taken every 72 hours for 10 doses.
273698|NCT01319383|P1|Participant Flow|Single and Multiple Dose|There are 3 Steps in this Arm: Step 1 a Baseline leukapheresis was completed to obtain resting CD4+ T cells for quantitation of resting CD4+ T cell infection (RCI) and resting CD4+ T cell- associated HIV RNA (RCVL); ex-vivo exposure. Step 2 measured the in-vivo response to single dose of VOR; Step 3 measured the in vivo response after each of 2 series of exposure to multiple doses of VOR 400 mg PO. In each series, 11 doses of VOR were administered for 3 days (M-T-W) and no doses for the remaining 4 days. A leukapheresis was completed 4 hours after the 11th dose to measure in vivo response.
273699|NCT01319383|O2|Outcome|2/Interval Doses (Multiple) Step 4|"Participants without dose-limiting symptoms and exhibiting an in vivo response to the paired dose of VOR dose were eligible to receive 10 doses of VOR 400 mg PO, given at the pre-determined interval. Participant took the PO doses at home per schedule with daily telephone assessment of symptoms and clinical assessments at after the 3rd, 5th, 8th and 10th doses. Participant were only given the required doses for administration between visits.~Leukapheresis procedure performed 4 hours after the 10th dose to measure RCVL in-vivo response."
273700|NCT01319383|O1|Outcome|1/Single and Multiple Dose, Step 3|Participants without dose-limiting symptoms and exhibiting an in vivo response to single VOR doses were eligible to receive multiple doses of VOR 400 mg. The first dose was administered in clinic with observation for symptoms for 1 hour post dose. Symptoms were assessed daily and on the third day 4 hours after the dose. These participants took VOR 400 mg (PO) in the AM for 3 days each week (dose every M-T-W) for 3 weeks. On the 4th week, the participant took 2 doses of VOR 400 mg (M-T) in the AM. A leukapheresis was completed 4 hours after the 2nd dose of VOR to measure RCVL in-vivo response. After a 4 – 8 week rest period, participants without dose-limiting symptoms repeated the 4 week cycle.
273701|NCT01319383|O2|Outcome|2/Interval Dosing, Steps 2, 3 and 4|All eligible participants in the Interval Dosing Arm who received at least one dose of VOR 400 mg PO..
273702|NCT01319383|O1|Outcome|1/Single & Multiple Dose, Steps 2 and 3|All eligible participants in the Single and Multiple Arm who received at least one dose of VOR 400 mg PO.
273703|NCT01319383|O2|Outcome|2/Interval Dosing, Steps 2, 3 and 4|All eligible participants in the Interval Dosing Arm who received at least one dose of VOR 400 mg PO.
273704|NCT01319383|O1|Outcome|1/Single & Multiple Dose, Steps 2 and 3|All eligible participants in the Single and Multiple Group Arm who received at least one dose of VOR 400 mg PO.
273705|NCT01319383|O2|Outcome|2/Interval Dosing, Steps 2, 3 and 4|All eligible participants in the Interval Dosing Arm who received at least one dose of VOR 400 mg PO
273706|NCT01319383|O1|Outcome|1/Single & Multiple Dose, Steps 2 and 3|All eligible participants in the Single and Multiple Group Arm who received at least one dose of VOR 400 mg PO
273707|NCT01319383|O1|Outcome|Interval Doses (Multiple) Step 4|"Participants without dose-limiting symptoms and exhibiting an in vivo response to the paired doses of VOR 400 mg PO were eligible to receive 10 doses of VOR, given at the pre-determined interval. Participant took the PO doses at home per schedule with daily telephone assessment of symptoms and clinical assessments at after the 3rd, 5th, 8th and 10th doses. Participant were only given the required doses for administration between visits.~Leukapheresis procedure performed 4 hours after the 10th dose to measure RCVL in-vivo response."
273708|NCT01319383|O2|Outcome|Interval Dosing, Step 3 (72 Hour Interval)|Participants without dose-limiting symptoms and exhibiting an in vivo response to single VOR dose were eligible to receive 2 doses of VOR 400 mg PO, given at the pre-determined interval of 72 hours. Participant took the PO doses at home per schedule with daily telephone assessment of symptoms. Leukapheresis procedure performed 4 hours after the 2nd dose to measure RCVL in-vivo response.
273709|NCT01319383|O1|Outcome|Interval Dosing , Step 3 (48 hr Interval)|Participants without dose-limiting symptoms and exhibiting an in vivo response to single VOR dose were eligible to receive 2 doses of VOR 400 mg PO, given at the pre-determined interval of 48 hours. Participant took the PO doses at home per schedule with daily telephone assessment of symptoms. Leukapheresis procedure performed 4 hours after the 2nd dose to measure RCVL in-vivo response.
273710|NCT01319383|O1|Outcome|Arm 1 - Single and Multiple Dose, Step 3|Participants without dose-limiting symptoms and exhibiting an in vivo response to single VOR doses were eligible to receive multiple doses of VOR 400 mg. The first dose was administered in clinic with observation for symptoms for 1 hour post dose. Symptoms were assessed daily and on the third day 4 hours after the dose. These participants took VOR 400 mg (PO) in the AM for 3 days each week (dose every M-T-W) for 3 weeks. On the 4th week, the participant took 2 doses of VOR 400 mg (M-T) in the AM. A leukapheresis was completed 4 hours after the 2nd dose of VOR to measure RCVL in-vivo response. After a 4 – 8 week rest period, participants without dose-limiting symptoms repeated the 4 week cycle.
273711|NCT01319383|O2|Outcome|2/Interval Dosing, Visit 3|Participants enrolled in Arm 2 receiving a single dose of VOR 400 mg PO after demonstrating an ex vivo response at baseline. Symptoms were assessed over 12 hours and pharmacokinetic samples obtained. Leukapheresis procedure was performed 4 hours after the dose to measure RCVL in-vivo response.
273712|NCT01319383|O1|Outcome|1/Single & Multiple Dose, Step 2, Visit 5|Participants enrolled in Arm 1 were given one dose of VOR 200 mg by mouth (PO), symptoms were assessed over 12 hours and pharmacokinetic samples obtained. Leukapheresis procedure was performed 4 hours after the dose to measure RCVL in-vivo response.
273733|NCT01319045|O1|Outcome|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.~Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
273797|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
273713|NCT01319383|E1|Reported Event|Open Label - Translational Research Study|"Period One: Step 1 (ex-vivo), Step 2 (single dose) and Step 3 (multiple dose). Advancement to each step required demonstration of significant HIV-1 RNA expression per 1 million RCVL response to VOR. Step 1: All participants had an ex-vivo exposure to VOR. Step 2: Participants with and without an ex-vivo response received 1 single dose VOR. Step 3: Participants demonstrating an in vivo response received multiple doses consisting of 2 series of 11 VOR doses each; with in vivo response measured after each series. Period One was stopped due to lack of significant in-vivo response to the multiple doses.~Period Two: Step 1, Step 2 and advancement criteria are the same as above. Step 3 (interval paired dose) and Step 4 (multiple interval doses). Participants without an ex-vivo response did not progress past Step 1. Step 3: Responders received 2 doses separated by 48 or 72 hours. Step 4: Responders then received 10 doses of VOR at pre-determined interval."
273714|NCT01319318|B1|Baseline|Pars Plana Vitrectomy|Pars plana vitrectomy performed in study eye on Day 0.
273715|NCT01319318|P1|Participant Flow|Pars Plana Vitrectomy|Pars plana vitrectomy performed in study eye on Day 0.
273716|NCT01319318|O1|Outcome|Pars Plana Vitrectomy|Pars plana vitrectomy performed in study eye on Day 0.
273717|NCT01319318|E1|Reported Event|Pars Plana Vitrectomy|Pars plana vitrectomy performed in study eye on Day 0.
273718|NCT01319110|B3|Baseline|Total|Total of all reporting groups
273719|NCT01319110|B2|Baseline|Placebo|"Patients will receive 20 ml chocolate Ensure (as a placebo) three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). Placebo will be given through pre-existing NG or OG tube.~Placebo: Patients will be given Chocolate Ensure via NG/ OG 3x daily as a placebo."
273720|NCT01319110|B1|Baseline|CoenzymeQ10|"Patients will receive CoenzymeQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff.~Coenzyme Q10: Patients will receive CoQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff."
273721|NCT01319110|P2|Participant Flow|Placebo|"Patients will receive 20 ml chocolate Ensure (as a placebo) three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). Placebo will be given through pre-existing NG or OG tube.~Placebo: Patients will be given Chocolate Ensure via NG/ OG 3x daily as a placebo."
273722|NCT01319110|P1|Participant Flow|CoenzymeQ10|"Patients will receive CoenzymeQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff.~Coenzyme Q10: Patients will receive CoQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff."
273723|NCT01319110|O2|Outcome|Placebo|"Patients will receive 20 ml chocolate Ensure (as a placebo) three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). Placebo will be given through pre-existing NG or OG tube.~Placebo: Patients will be given Chocolate Ensure via NG/ OG 3x daily as a placebo."
273724|NCT01319110|O1|Outcome|CoenzymeQ10|"Patients will receive CoenzymeQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff.~Coenzyme Q10: Patients will receive CoQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff."
273725|NCT01319110|O2|Outcome|Placebo|"Patients will receive 20 ml chocolate Ensure (as a placebo) three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). Placebo will be given through pre-existing NG or OG tube.~Placebo: Patients will be given Chocolate Ensure via NG/ OG 3x daily as a placebo."
273726|NCT01319110|O1|Outcome|CoenzymeQ10|"Patients will receive CoenzymeQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff.~Coenzyme Q10: Patients will receive CoQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff."
273727|NCT01319110|E2|Reported Event|Placebo|"Patients will receive 20 ml chocolate Ensure (as a placebo) three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). Placebo will be given through pre-existing NG or OG tube.~Placebo: Patients will be given Chocolate Ensure via NG/ OG 3x daily as a placebo."
273728|NCT01319110|E1|Reported Event|CoenzymeQ10|"Patients will receive CoenzymeQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff.~Coenzyme Q10: Patients will receive CoQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff."
273729|NCT01319045|B1|Baseline|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.~Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
273730|NCT01319045|P1|Participant Flow|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.~Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
273731|NCT01319045|O1|Outcome|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.~Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
273732|NCT01319045|O1|Outcome|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.~Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
273734|NCT01319045|O1|Outcome|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.~Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
273735|NCT01319045|E1|Reported Event|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.~Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
273736|NCT01318993|B1|Baseline|GSK1605786A 500 mg BID|Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.
273737|NCT01318993|P1|Participant Flow|GSK1605786A|Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.
273738|NCT01318993|O1|Outcome|GSK1605786A 500 mg BID|Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.
273739|NCT01318993|O1|Outcome|GSK1605786A 500 mg BID|Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.
273740|NCT01318993|O1|Outcome|GSK1605786A 500 mg BID|Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.
273741|NCT01318993|O1|Outcome|GSK1605786A 500 mg BID|Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.
273742|NCT01318993|O1|Outcome|GSK1605786A 500 mg BID|Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.
273743|NCT01318993|O1|Outcome|GSK1605786A 500 mg BID|Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.
273744|NCT01318993|O1|Outcome|GSK1605786A 500 mg BID|Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.
273745|NCT01318993|O1|Outcome|GSK1605786A 500 mg BID|Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.
273746|NCT01318993|O1|Outcome|GSK1605786A 500 mg BID|Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.
273747|NCT01318993|O1|Outcome|GSK1605786A 500 mg BID|Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.
273748|NCT01318993|O1|Outcome|GSK1605786A 500 mg BID|Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.
273749|NCT01318993|O1|Outcome|GSK1605786A 500 mg BID|Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.
273750|NCT01318993|O1|Outcome|GSK1605786A 500 mg BID|Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.
273751|NCT01318993|E1|Reported Event|GSK1605786A|Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.
273752|NCT01318967|B1|Baseline|Furosemide|"With and without furosemide~Furosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide."
273753|NCT01318967|P1|Participant Flow|Furosemide|"With and without furosemide~Furosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide."
273754|NCT01318967|O1|Outcome|MRI After Furosemide|"After the PAH measurement is complete, subjects receive 20 mg furosemide and undergo BOLD MRI to estimate renal blood flow~Furosemide: Renal blood flow is measured after the administration of 20 mg of furosemide during MRI scan only."
273755|NCT01318967|O1|Outcome|Furosemide|"With and without furosemide~Furosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide.~Renal blood flow is measured by PAH method and by MRI method"
273756|NCT01318967|E1|Reported Event|Furosemide|"With and without furosemide~Furosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide."
273757|NCT01318915|B1|Baseline|Induction (Rituximab and ATG)|Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given around day -6 pre-transplant, and the second dose was given on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
306235|NCT01229228|B1|Baseline|Naproxen Test (Lower Dose)|
273758|NCT01318915|P1|Participant Flow|Induction (Rituximab and ATG)|Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given around day -6 pre-transplant, and the second dose was given on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
273759|NCT01318915|O1|Outcome|Induction (Rituximab and ATG)|Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given around day -6 pre-transplant, and the second dose was given on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
273760|NCT01318915|E1|Reported Event|Induction (Rituximab and ATG)|Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given around day -6 pre-transplant, and the second dose was given on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
273761|NCT01318876|B1|Baseline|Health Care Workers|HCW who had completed at least 1 survey (n=6269) and not the number of participants enrolled in the study.
273762|NCT01318876|P1|Participant Flow|Health Care Workers|
273763|NCT01318876|O1|Outcome|HCW From All Sites|
273764|NCT01318876|O1|Outcome|HCW From All Sites|
273765|NCT01318876|E1|Reported Event|HCW From All Sites|
273766|NCT01318733|B1|Baseline|CD07805/47 Gel 0.5%|CD07805/47 Gel 0.5% once daily
273767|NCT01318733|P1|Participant Flow|CD07805/47 Gel 0.5%|CD07805/47 Gel 0.5% once daily
273768|NCT01318733|O1|Outcome|CD07805/47 Gel 0.5% QD|
273769|NCT01318733|E1|Reported Event|CD07805/47 Gel 0.5%|
273770|NCT01318694|B5|Baseline|Total|Total of all reporting groups
273771|NCT01318694|B4|Baseline|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
273772|NCT01318694|B3|Baseline|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
273773|NCT01318694|B2|Baseline|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
273774|NCT01318694|B1|Baseline|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
273775|NCT01318694|P4|Participant Flow|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
273776|NCT01318694|P3|Participant Flow|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg once daily (QD) for 47 weeks
273777|NCT01318694|P2|Participant Flow|Treatment Arm B|Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)
273778|NCT01318694|P1|Participant Flow|Treatment Arm A|Alisporivir (ALV) 600 mg twice daily (BID) with Peginterferon alfa-2a (PEG) and ribavirin (RBV) for 1 week, followed by an additional 23 or 47 weeks according to response-guided treatment duration (RGT)
273779|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
273780|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
273781|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
273782|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
273783|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
273784|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
273785|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
273786|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
273787|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
273788|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
273789|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
273790|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
273791|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
273792|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
273793|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
273794|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
273798|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
273799|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
273800|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
273801|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
273802|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
273803|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
273804|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
273805|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
273806|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
273807|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
273808|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
273809|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
273810|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
273811|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
273812|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
273813|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
273814|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
273815|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
273816|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
273817|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
273818|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
273819|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
273820|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
273821|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
273822|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
273823|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
273824|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
273825|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
273826|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
273827|NCT01318694|E4|Reported Event|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
273828|NCT01318694|E3|Reported Event|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
273829|NCT01318694|E2|Reported Event|Treatment Arm B|Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)
273830|NCT01318694|E1|Reported Event|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
273831|NCT01318538|B3|Baseline|Total|Total of all reporting groups
273832|NCT01318538|B2|Baseline|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community. NOTE: Baseline characteristics reported in Table Below reflect all participants including men assigned to the GDC condition. Analysis of data for study specific aims include only women randomized to WRG (N=52) and GDC (N=48).
273833|NCT01318538|B1|Baseline|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
273834|NCT01318538|P3|Participant Flow|Group Therapist|Therapists who ran and led the group sessions for both the single-gender Women's Recovery Group and mixed-gender Group Drug Counseling.
273870|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of hemoglobin.
273871|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
273835|NCT01318538|P2|Participant Flow|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
273836|NCT01318538|P1|Participant Flow|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
273837|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
273838|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
273839|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
273840|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
273841|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
273842|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
273843|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
273872|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing haemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of haemoglobin.
273873|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
306236|NCT01229228|P5|Participant Flow|Placebo|
273844|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
273845|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
273846|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
273847|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Participants in this analysis are the therapists that lead GDC groups. Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
273848|NCT01318538|O1|Outcome|Women's Recovery Group|Participants in this analysis are the therapists that lead the WRG groups. The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
273849|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
273850|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
273851|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
273852|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
273874|NCT01318512|E1|Reported Event|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
273853|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
273854|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
273855|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
273856|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
273857|NCT01318538|E2|Reported Event|Mixed-gender Group Drug Counseling|The GDC is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance dependence; 3) increase patients’ self-awareness of the problems that substance dependence has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse.
273858|NCT01318538|E1|Reported Event|Women's Recovery Group|The WRG is a manual-based group therapy for women heterogeneous with respect to their substance dependence, co-occurring psychiatric disorders, trauma history, and age and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (b) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (c) help participants with skills and strategies useful in preventing relapse and promote recovery.
273859|NCT01318512|B1|Baseline|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of hemoglobin.
273860|NCT01318512|P1|Participant Flow|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of hemoglobin.
273861|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
273862|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
273863|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
273864|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
273865|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
273866|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
273867|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
273868|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
273869|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
273875|NCT01318499|B4|Baseline|Total|Total of all reporting groups
306237|NCT01229228|P4|Participant Flow|Naprosyn 500 mg|
273876|NCT01318499|B3|Baseline|Nepafenac Vehicle 0.3%|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
273877|NCT01318499|B2|Baseline|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
273878|NCT01318499|B1|Baseline|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
273879|NCT01318499|P3|Participant Flow|Nepafenac Vehicle 0.3%|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
273880|NCT01318499|P2|Participant Flow|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
273881|NCT01318499|P1|Participant Flow|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
273882|NCT01318499|O3|Outcome|Nepafenac 0.3% Vehicle|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
273883|NCT01318499|O2|Outcome|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
273884|NCT01318499|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
273885|NCT01318499|O3|Outcome|Nepafenac 0.3% Vehicle|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
273886|NCT01318499|O2|Outcome|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
273887|NCT01318499|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
273888|NCT01318499|O3|Outcome|Nepafenac Vehicle 0.3%|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
273889|NCT01318499|O2|Outcome|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
273890|NCT01318499|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
273891|NCT01318499|O2|Outcome|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
273892|NCT01318499|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
273893|NCT01318499|O2|Outcome|Nepafenac Vehicle 0.3%|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
273894|NCT01318499|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
273895|NCT01318499|E3|Reported Event|Nepafenac Vehicle 0.3%|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
273896|NCT01318499|E2|Reported Event|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
273897|NCT01318499|E1|Reported Event|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
273898|NCT01318408|B1|Baseline|Open Label|All participants received study drug.
273899|NCT01318408|P1|Participant Flow|Open Label|All participants received study drug.
273900|NCT01318408|O1|Outcome|Open Label|All participants received study drug.
273901|NCT01318408|O1|Outcome|Open Label|All participants received study drug.
273902|NCT01318408|E1|Reported Event|Open Label|All participants received study drug. Four withdrew due to adverse events; related to fatigue.
273903|NCT01318382|B1|Baseline|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker and had the extent of their recovery from NMB monitored by a TOF-Watch SX®.
273904|NCT01318382|P1|Participant Flow|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker and had the extent of their recovery from neuromuscular blockade (NMB) monitored by a TOF-Watch SX®.
273905|NCT01318382|O1|Outcome|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker, had the extent of their recovery from NMB monitored by a TOF-Watch SX® and had an evaluable TOF Ratio at time of PACU arrival.
273906|NCT01318382|O1|Outcome|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker, had the extent of their recovery from NMB monitored by a TOF-Watch SX® and had an evaluable TOF Ratio at time of tracheal extubation.
273907|NCT01318382|O1|Outcome|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker, had the extent of their recovery from NMB monitored by a TOF-Watch SX® and had an evaluable TOF Ratio at time of PACU arrival.
273908|NCT01318382|O1|Outcome|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker, had the extent of their recovery from NMB monitored by a TOF-Watch SX® and had an evaluable TOF Ratio at time of tracheal extubation.
273909|NCT01318382|E1|Reported Event|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker and had the extent of their recovery from NMB monitored by a TOF-Watch SX®.
273910|NCT01318278|B4|Baseline|Total|Total of all reporting groups
273911|NCT01318278|B3|Baseline|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
273912|NCT01318278|B2|Baseline|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
273913|NCT01318278|B1|Baseline|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
273914|NCT01318278|P3|Participant Flow|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
273915|NCT01318278|P2|Participant Flow|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
273916|NCT01318278|P1|Participant Flow|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
273917|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
273918|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
273919|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
273920|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
273921|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
273922|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
273923|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
273924|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
273925|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
273926|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
273927|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
274306|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
273928|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
273929|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
273930|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
273931|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
273932|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
273933|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
273934|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
273935|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
273936|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
273937|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
273938|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
273939|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
273940|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
273941|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
273942|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
273943|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
273944|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
273945|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
273946|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
273947|NCT01318278|O3|Outcome|Comparison Group|Infants not diagnosed with hypotension in first 24 hours
273948|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
273949|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
273950|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
273951|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
273952|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
273953|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
273954|NCT01318278|E3|Reported Event|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
273955|NCT01318278|E2|Reported Event|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
273956|NCT01318278|E1|Reported Event|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
273957|NCT01318135|B5|Baseline|Total|Total of all reporting groups
273958|NCT01318135|B4|Baseline|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
273959|NCT01318135|B3|Baseline|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
273960|NCT01318135|B2|Baseline|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
273961|NCT01318135|B1|Baseline|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
273962|NCT01318135|P8|Participant Flow|Metformin Monotherapy Group* → 25 mg Combination Group|"Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.~*for participants from the metformin 500 mg or 750 mg dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study."
273963|NCT01318135|P7|Participant Flow|Metformin Monotherapy Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.~*for participants from the metformin 500 mg or 750 mg dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study."
273964|NCT01318135|P6|Participant Flow|CCT/006 - 25 mg Dose Group* → 25 mg Combination Group|"Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.~*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study."
273965|NCT01318135|P5|Participant Flow|CCT/006 - 12.5 mg Dose Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.~*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study."
273966|NCT01318135|P4|Participant Flow|Glimepiride Monotherapy Group* → 25 mg Combination Group|"Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.~*for participants from the glimepiride 1, 2, 3 or 4 mg dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study."
273967|NCT01318135|P3|Participant Flow|Glimepiride Monotherapy Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.~*for participants from the glimepiride 1, 2, 3 or 4 mg dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study."
273968|NCT01318135|P2|Participant Flow|CCT/005 - 25 mg Dose Group* → 25 mg Combination Dose Group|"Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.~*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study."
273969|NCT01318135|P1|Participant Flow|CCT/005 - 12.5 mg Dose Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.~*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study."
273970|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
273971|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
273972|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
273973|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
273974|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
273975|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
273976|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
273977|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
273978|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274008|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
273979|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
273980|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
273981|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
273982|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
273983|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
273984|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
273985|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
273986|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
273987|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
273988|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
273989|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
273990|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
273991|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
273992|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
273993|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
273994|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
273995|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
273996|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
273997|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
273998|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
273999|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274000|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274001|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274002|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274003|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274004|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274005|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274006|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274007|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274009|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274010|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274011|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274012|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274013|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274014|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274015|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274016|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274017|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274018|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274019|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274020|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274021|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274022|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274023|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274024|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274025|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274026|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274027|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274028|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274029|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274030|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274031|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274032|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274033|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274034|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274035|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274036|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274037|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
306238|NCT01229228|P3|Participant Flow|Naprosyn 250 mg|
274038|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274039|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274040|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274041|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274042|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274043|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274044|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274045|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274046|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274047|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274048|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274049|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274050|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274051|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274052|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274053|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274054|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274055|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274056|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274057|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274058|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274059|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274060|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274061|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274062|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274063|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274064|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274065|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274066|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274067|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274068|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274069|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274070|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274071|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274072|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274073|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274074|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274075|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274076|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274077|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274078|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274079|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274080|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274081|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274082|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274083|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274084|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274085|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274086|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274087|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274088|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274089|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274090|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274091|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274092|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274093|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274094|NCT01318135|E4|Reported Event|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274095|NCT01318135|E3|Reported Event|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
274096|NCT01318135|E2|Reported Event|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274097|NCT01318135|E1|Reported Event|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
274098|NCT01318122|B3|Baseline|Total|Total of all reporting groups
274099|NCT01318122|B2|Baseline|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274100|NCT01318122|B1|Baseline|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274101|NCT01318122|P4|Participant Flow|Pioglitazone Monotherapy Group* → 25 mg Combination Group|"Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.~*for participants from the pioglitazone 15 mg or 30 mg dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study."
274102|NCT01318122|P3|Participant Flow|Pioglitazone Monotherapy Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.~*for participants from the pioglitazone 15 mg or 30 mg dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study."
274103|NCT01318122|P2|Participant Flow|CCT/004 - 25 mg Dose Group* → 25 mg Combination Dose Group|"Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.~*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study."
274104|NCT01318122|P1|Participant Flow|CCT/004 - 12.5 mg Dose Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.~*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study."
274105|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274106|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274107|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274108|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274109|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274110|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274111|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274112|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274113|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274114|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274115|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274116|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274117|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274118|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274119|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274120|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274121|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274122|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274123|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274124|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274125|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274126|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274303|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
274127|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274128|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274129|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274130|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274131|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274132|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274133|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274134|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274135|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274136|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274137|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274138|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274139|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274140|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274141|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274142|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274143|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274144|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274145|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274146|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274147|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274148|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274149|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274150|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274151|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274152|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274153|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274154|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274155|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274156|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274157|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274158|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274159|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274160|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274161|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274162|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274163|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274164|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274165|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274166|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274167|NCT01318122|E2|Reported Event|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|"Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.~*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study."
274168|NCT01318122|E1|Reported Event|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
274169|NCT01318109|B4|Baseline|Total|Total of all reporting groups
274170|NCT01318109|B3|Baseline|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
274171|NCT01318109|B2|Baseline|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
274172|NCT01318109|B1|Baseline|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
274173|NCT01318109|P3|Participant Flow|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
274174|NCT01318109|P2|Participant Flow|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
274175|NCT01318109|P1|Participant Flow|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
274176|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
274177|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
274178|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
274179|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
274180|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
274181|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
274182|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
274183|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
274184|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
274185|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
274186|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
274187|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
274188|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
274189|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
274190|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
274191|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
274192|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
274193|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
306239|NCT01229228|P2|Participant Flow|Naproxen Test (Upper Dose)|
274194|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
274195|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
274196|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
274197|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
274198|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
274199|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
274200|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
274201|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
274202|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
274203|NCT01318109|E3|Reported Event|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
274204|NCT01318109|E2|Reported Event|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
274205|NCT01318109|E1|Reported Event|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
274206|NCT01318083|B4|Baseline|Total|Total of all reporting groups
274207|NCT01318083|B3|Baseline|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
274208|NCT01318083|B2|Baseline|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
274209|NCT01318083|B1|Baseline|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
274210|NCT01318083|P3|Participant Flow|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
274211|NCT01318083|P2|Participant Flow|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
274212|NCT01318083|P1|Participant Flow|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
274213|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
274214|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
274215|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
274216|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
274217|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
274218|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
274219|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
274220|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
274221|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
274222|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
274223|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
274224|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
274225|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
274226|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
274304|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
274227|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
274228|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
274229|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
274230|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
274231|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
274232|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
274233|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
274234|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
274235|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
274236|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
274237|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
274238|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
274239|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
274240|NCT01318083|E3|Reported Event|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
274241|NCT01318083|E2|Reported Event|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
274242|NCT01318083|E1|Reported Event|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
274243|NCT01318070|B4|Baseline|Total|Total of all reporting groups
274244|NCT01318070|B3|Baseline|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274245|NCT01318070|B2|Baseline|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274246|NCT01318070|B1|Baseline|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274247|NCT01318070|P3|Participant Flow|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274248|NCT01318070|P2|Participant Flow|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274249|NCT01318070|P1|Participant Flow|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274250|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274251|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274252|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274253|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274254|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274255|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274256|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274257|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274258|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274259|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274260|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274261|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274262|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274263|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274264|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274265|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274266|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274267|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274268|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274269|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274270|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274271|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274272|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274273|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274274|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274275|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274276|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274277|NCT01318070|E3|Reported Event|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274278|NCT01318070|E2|Reported Event|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274279|NCT01318070|E1|Reported Event|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
274280|NCT01317901|B3|Baseline|Total|Total of all reporting groups
274281|NCT01317901|B2|Baseline|TRU-016 (20 mg/kg) +Bendamustine+Rituximab|
274282|NCT01317901|B1|Baseline|TRU-016 (10 mg/kg) +Bendamustine+Rituximab|
274283|NCT01317901|P2|Participant Flow|20 mg/kg TRU-016+Bendamustine+Rituximab|"TRU-016: 100 mg TRU-016 lyophilized solution for infusion at 10 mg/kg (or 6 mg/kg, if necessary) on Days 1 and 15 of each 28 day cycle Rituximab: 375 mg/m^2 rituximab was administered by IV infusion on Day 2 of each cycle.~Bendamustine: 90 mg/m^2 bendamustine was administered by IV infusion on Days 1 and 2 of each cycle."
274284|NCT01317901|P1|Participant Flow|10 mg/kg TRU-016+Bendamustine+Rituximab|"TRU-016: 100 mg TRU-016 lyophilized solution for infusion at 10 mg/kg (or 6 mg/kg, if necessary) on Days 1 and 15 of each 28 day cycle Rituximab: 375 mg/m^2 rituximab was administered by IV infusion on Day 2 of each cycle.~Bendamustine: 90 mg/m^2 bendamustine was administered by IV infusion on Days 1 and 2 of each cycle."
274285|NCT01317901|O2|Outcome|20 mg/kg of TRU 016 + Bendamustine + Rituximab|20 mg/kg of TRU 016 combined with rituximab 375 mg/m^2 and bendamustine 90 mg/m^2 were evaluated during up to 6 cycles (28 days each). TRU-016 was administered by intravenous (IV) infusion on Days 1 and 15 of each cycle. Rituximab was administered by IV infusion on Day 2 of each cycle. Bendamustine was administered by IV infusion on Days 1 and 2 of each cycle. Subjects received study treatment for up to 6 cycles.
274286|NCT01317901|O1|Outcome|TRU-016 (10 mg/kg) + Bendamustine + Rituximab|"10 mg/kg of TRU 016 combined with rituximab 375 mg/m^2 and bendamustine 90 mg/m^2 were evaluated during up to 6 cycles (28 days each). TRU-016 was administered by intravenous (IV) infusion on Days 1 and 15 of each cycle. Rituximab was administered by IV infusion on Day 2 of each cycle. Bendamustine was administered by IV infusion on Days 1 and 2 of each cycle. Subjects received study treatment for up to 6 cycles.~TRU-016: 100 mg TRU-016 lyophilized solution for infusion at 10 or 20 mg/kg (or 6 mg/kg, if necessary) on Days 1 and 15 of each 28 day cycle~Bendamustine: Bendamustine by IV administration on Days 1 and 2 of each 28 day cycle.~Rituximab: Rituximab by IV administration at 375 mg/m^2 on Day 2 of each 28 day cycle."
274287|NCT01317901|E2|Reported Event|TRU-016 (20 mg/kg)|TRU-016 (20 mg/kg) + bendamustine + rituximab
274288|NCT01317901|E1|Reported Event|TRU-016 (10 mg/kg)|TRU-016 (10 mg/kg) + bendamustine + rituximab
274289|NCT01317797|B4|Baseline|Total|Total of all reporting groups
274290|NCT01317797|B3|Baseline|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
274291|NCT01317797|B2|Baseline|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
274292|NCT01317797|B1|Baseline|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
274293|NCT01317797|P3|Participant Flow|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
274294|NCT01317797|P2|Participant Flow|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
274295|NCT01317797|P1|Participant Flow|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
274296|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
274297|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
274298|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
274299|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
274300|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
274301|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
274302|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
274307|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
274308|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
274309|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
274310|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
274311|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
274312|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
274313|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
274314|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
274315|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
274316|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
274317|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
274318|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
274319|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
274320|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
274321|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
274322|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
274323|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
274324|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
274325|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
274326|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
274327|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
274328|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
274329|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
274330|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
274331|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
274332|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
274333|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
274334|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
274335|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
274336|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
274337|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
274338|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
274339|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
274340|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
274341|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
274342|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
274343|NCT01317797|E3|Reported Event|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
274344|NCT01317797|E2|Reported Event|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
274345|NCT01317797|E1|Reported Event|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
274346|NCT01317667|B4|Baseline|Total|Total of all reporting groups
274347|NCT01317667|B3|Baseline|Group 3|RVEc vaccine 100 μg/dose x 1 dose
274348|NCT01317667|B2|Baseline|Group 2|RVEc vaccine 50 μg/dose x 3 doses
274349|NCT01317667|B1|Baseline|Group 1|RVEc vaccine 20 μg/dose x 3 doses
274350|NCT01317667|P3|Participant Flow|Group 3|RVEc vaccine 100 μg/dose x 1 dose
274351|NCT01317667|P2|Participant Flow|Group 2|RVEc vaccine 50 μg/dose x 3 doses
274352|NCT01317667|P1|Participant Flow|Group 1|RVEc vaccine 20 μg/dose x 3 doses
274353|NCT01317667|O3|Outcome|Group 3|RVEc vaccine 100 μg/dose x 1 dose
274354|NCT01317667|O2|Outcome|Group 2|RVEc vaccine 50 μg/dose x 3 doses
274355|NCT01317667|O1|Outcome|Group 1|RVEc vaccine 20 μg/dose x 3 doses
274356|NCT01317667|O3|Outcome|Group 3|RVEc vaccine 100 μg/dose x 1 dose
274357|NCT01317667|O2|Outcome|Group 2|RVEc vaccine 50 μg/dose x 3 doses
274358|NCT01317667|O1|Outcome|Group 1|RVEc vaccine 20 μg/dose x 3 doses
274359|NCT01317667|E3|Reported Event|Group 3|RVEc vaccine 100 μg/dose x 1 dose
274360|NCT01317667|E2|Reported Event|Group 2|RVEc vaccine 50 μg/dose x 3 doses
274361|NCT01317667|E1|Reported Event|Group 1|RVEc vaccine 20 μg/dose x 3 doses
274362|NCT01317641|B10|Baseline|Total|Total of all reporting groups
274363|NCT01317641|B9|Baseline|Phase 2 (1400mg/Day ODM-201)|Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously.
274364|NCT01317641|B8|Baseline|Phase 2 (400mg/Day ODM-201)|Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously.
274442|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
274365|NCT01317641|B7|Baseline|Phase 2 (200mg/Day ODM-201)|Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously
274366|NCT01317641|B6|Baseline|Phase 1, 1800mg/Day ODM-201|Dose escalation. Participants received twice daily of oral ODM-201 continuously.
274367|NCT01317641|B5|Baseline|Phase 1, 1400mg/Day ODM-201|Dose escalation. Participants received twice daily of oral ODM-201 continuously.
274368|NCT01317641|B4|Baseline|Phase 1, 1000mg/Day ODM-201|Dose escalation. Participants received twice daily of oral ODM-201 continuously.
274369|NCT01317641|B3|Baseline|Phase 1, 600mg/Day ODM-201|Dose escalation. Participants received twice daily of oral ODM-201 continuously.
274370|NCT01317641|B2|Baseline|Phase 1, 400mg/Day ODM-201|Dose escalation. Participants received twice daily of oral ODM-201 continuously.
274371|NCT01317641|B1|Baseline|Phase 1, 200mg/Day ODM-201|Dose escalation. Participants received twice daily of oral ODM-201 continuously.
274372|NCT01317641|P9|Participant Flow|Phase 2: ODM-201 1400mg/Day|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
274373|NCT01317641|P8|Participant Flow|Phase 2: ODM-201 400mg/Day|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
274374|NCT01317641|P7|Participant Flow|Phase 2: ODM-201 200mg/Day|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
274375|NCT01317641|P6|Participant Flow|Phase 1: ODM-201 1800 mg/Day|Dose escalation
274376|NCT01317641|P5|Participant Flow|Phase 1: ODM-201 1400 mg/Day|Dose escalation
274377|NCT01317641|P4|Participant Flow|Phase 1: ODM-201 1000 mg/Day|Dose escalation
274378|NCT01317641|P3|Participant Flow|Phase 1: ODM-201 600 mg/Day|Dose escalation
274379|NCT01317641|P2|Participant Flow|Phase 1: ODM-201 400 mg/Day|Dose escalation
274380|NCT01317641|P1|Participant Flow|Phase 1: ODM-201 200 mg/Day|Dose escalation
274381|NCT01317641|O6|Outcome|1800 mg/Day ODM-201|Phase 1
274382|NCT01317641|O5|Outcome|1400 mg/Day ODM-201|Phase 1
274383|NCT01317641|O4|Outcome|1000 mg/Day ODM-201|Phase 1
274384|NCT01317641|O3|Outcome|600 mg/Day ODM-201|Phase 1
274385|NCT01317641|O2|Outcome|400 mg/Day ODM-201|Phase 1
274386|NCT01317641|O1|Outcome|200 mg/Day ODM-201|Phase 1
274387|NCT01317641|O6|Outcome|1800 mg/Day ODM-201|Phase 1
274388|NCT01317641|O5|Outcome|1400 mg/Day ODM-201|Phase 1
274389|NCT01317641|O4|Outcome|1000 mg/Day ODM-201|Phase 1
274390|NCT01317641|O3|Outcome|600 mg/Day ODM-201|Phase 1
274391|NCT01317641|O2|Outcome|400 mg/Day ODM-201|Phase 1
274392|NCT01317641|O1|Outcome|200 mg/Day ODM-201|Phase 1
274393|NCT01317641|O6|Outcome|1800 mg/Day ODM-201|Phase 1
274394|NCT01317641|O5|Outcome|1400 mg/Day ODM-201|Phase 1
274395|NCT01317641|O4|Outcome|1000 mg/Day ODM-201|Phase 1
274396|NCT01317641|O3|Outcome|600 mg/Day ODM-201|Phase 1
274397|NCT01317641|O2|Outcome|400 mg/Day ODM-201|Phase 1
274398|NCT01317641|O1|Outcome|200 mg/Day ODM-201|Phase 1
274399|NCT01317641|O6|Outcome|1800 mg/Day ODM-201|Phase 1
274400|NCT01317641|O5|Outcome|1400 mg/Day ODM-201|Phase 1
274401|NCT01317641|O4|Outcome|1000 mg/Day ODM-201|Phase 1
274402|NCT01317641|O3|Outcome|600 mg/Day ODM-201|Phase 1
274403|NCT01317641|O2|Outcome|400 mg/Day ODM-201|Phase 1
274404|NCT01317641|O1|Outcome|200 mg/Day ODM-201|Phase 1
274405|NCT01317641|O6|Outcome|1800 mg/Day ODM-201|Phase 1
274406|NCT01317641|O5|Outcome|1400 mg/Day ODM-201|Phase 1
274407|NCT01317641|O4|Outcome|1000 mg/Day ODM-201|Phase 1
274408|NCT01317641|O3|Outcome|600 mg/Day ODM-201|Phase 1
274409|NCT01317641|O2|Outcome|400 mg/Day ODM-201|Phase 1
274410|NCT01317641|O1|Outcome|200 mg/Day ODM-201|Phase 1
274411|NCT01317641|O6|Outcome|1800 mg/Day ODM-201|Phase 1
274412|NCT01317641|O5|Outcome|1400 mg/Day ODM-201|Phase 1
274413|NCT01317641|O4|Outcome|1000 mg/Day ODM-201|Phase 1
274414|NCT01317641|O3|Outcome|600 mg/Day ODM-201|Phase 1
274415|NCT01317641|O2|Outcome|400 mg/Day ODM-201|Phase 1
274416|NCT01317641|O1|Outcome|200 mg/Day ODM-201|Phase 1
274417|NCT01317641|O4|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
274418|NCT01317641|O3|Outcome|1000mg/Day ODM-201|Phase 1
274419|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
274420|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
274421|NCT01317641|O5|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
274422|NCT01317641|O4|Outcome|1000mg/Day ODM-201|Phase 1
274423|NCT01317641|O3|Outcome|600mg/Day ODM-201|Phase 1
274424|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
274425|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
274426|NCT01317641|O5|Outcome|1800mg/Day ODM-201|Phase 1
274427|NCT01317641|O4|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
274428|NCT01317641|O3|Outcome|1000mg/Day ODM-201|Phase 1
274429|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
274430|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
274431|NCT01317641|O3|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
274432|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
274433|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
274434|NCT01317641|O5|Outcome|1800mg/Day ODM-201|Phase 1
274435|NCT01317641|O4|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
274436|NCT01317641|O3|Outcome|1000mg/Day ODM-201|Phase 1
274437|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
274438|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
274439|NCT01317641|O5|Outcome|1800mg/Day ODM-201|Phase 1
274440|NCT01317641|O4|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
274441|NCT01317641|O3|Outcome|600mg/Day ODM-201|Phase 1
274444|NCT01317641|O4|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
274445|NCT01317641|O3|Outcome|1000mg/Day ODM-201|Phase 1
274446|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
274447|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
274448|NCT01317641|O6|Outcome|1800mg/Day ODM-201|Phase 1
274449|NCT01317641|O5|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
274450|NCT01317641|O4|Outcome|1000mg/Day ODM-201|Phase 1
274451|NCT01317641|O3|Outcome|600mg/Day ODM-201|Phase 1
274452|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
274453|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
274454|NCT01317641|O6|Outcome|1800mg/Day ODM-201|phase 1
274455|NCT01317641|O5|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
274456|NCT01317641|O4|Outcome|1000mg/Day ODM-201|phase 1
274457|NCT01317641|O3|Outcome|600mg/Day ODM-201|phase 1
274458|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
274459|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
274460|NCT01317641|O6|Outcome|Phase 1: ODM-201 1800 mg/Day|Participants received twice daily of oral ODM-201 continuously.
274461|NCT01317641|O5|Outcome|Phase 1: ODM-201 1400 mg/Day|Participants received twice daily of oral ODM-201 continuously.
274462|NCT01317641|O4|Outcome|Phase 1: ODM-201 1000 mg/Day|Participants received twice daily of oral ODM-201 continuously.
274463|NCT01317641|O3|Outcome|Phase 1: ODM-201 600 mg/Day|Participants received twice daily of oral ODM-201 continuously.
274464|NCT01317641|O2|Outcome|Phase 1: ODM-201 400 mg/Day|Participants received twice daily of oral ODM-201 continuously.
274465|NCT01317641|O1|Outcome|Phase 1: ODM-201 200 mg/Day|Participants received twice daily of oral ODM-201 continuously.
274466|NCT01317641|O6|Outcome|Phase 1: ODM-201 1800 mg/Day|Participants received twice daily of oral ODM-201 continuously.
274467|NCT01317641|O5|Outcome|Phase 1: ODM-201 1400 mg/Day|Participants received twice daily of oral ODM-201 continuously.
274468|NCT01317641|O4|Outcome|Phase 1: ODM-201 1000 mg/Day|Participants received twice daily of oral ODM-201 continuously.
274469|NCT01317641|O3|Outcome|Phase 1: ODM-201 600 mg/Day|Participants received twice daily of oral ODM-201 continuously.
274470|NCT01317641|O2|Outcome|Phase 1: ODM-201 400 mg/Day|Participants received twice daily of oral ODM-201 continuously.
274471|NCT01317641|O1|Outcome|Phase 1: ODM-201 200 mg/Day|Participants received twice daily of oral ODM-201 continuously.
274472|NCT01317641|E9|Reported Event|Phase 2, 1400mg/Day ODM-201|Dose expansion
274473|NCT01317641|E8|Reported Event|Phase 2, 400mg/Day ODM-201|Dose expansion
274474|NCT01317641|E7|Reported Event|Phase 2, 200mg/Day ODM-201|Dose expansion
274475|NCT01317641|E6|Reported Event|Phase 1, 1800mg/Day ODM-201|Dose escalation
274476|NCT01317641|E5|Reported Event|Phase 1, 1400mg/Day ODM-201|Dose escalation
274477|NCT01317641|E4|Reported Event|Phase 1, 1000mg/Day ODM-201|Dose escalation
274478|NCT01317641|E3|Reported Event|Phase 1, 600mg/Day ODM-201|Dose escalation
274479|NCT01317641|E2|Reported Event|Phase 1, 400mg/Day ODM-201|Dose escalation
274480|NCT01317641|E1|Reported Event|Phase 1, 200mg/Day ODM-201|Dose escalation
274481|NCT01317615|B1|Baseline|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
274482|NCT01317615|P1|Participant Flow|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
274483|NCT01317615|O1|Outcome|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
274484|NCT01317615|O1|Outcome|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
274485|NCT01317615|O1|Outcome|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
274486|NCT01317615|O1|Outcome|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
274487|NCT01317615|O1|Outcome|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
274488|NCT01317615|O1|Outcome|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
274489|NCT01317615|E1|Reported Event|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
274490|NCT01317160|B3|Baseline|Total|Total of all reporting groups
274491|NCT01317160|B2|Baseline|Intermittent Pneumatic Compression (IPC)|"Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.~Intermittent pneumatic compression (IPC): 6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute."
274492|NCT01317160|B1|Baseline|Routine Care: Plaster Cast Treatment|Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
274522|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
274523|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
274493|NCT01317160|P2|Participant Flow|Intermittent Pneumatic Compression (IPC)|"Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.~Intermittent pneumatic compression (IPC): 6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute."
274494|NCT01317160|P1|Participant Flow|Routine Care: Plaster Cast Treatment|Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
274495|NCT01317160|O2|Outcome|Intermittent Pneumatic Compression (IPC)|"Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.~Intermittent pneumatic compression (IPC): 6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute."
274496|NCT01317160|O1|Outcome|Routine Care: Plaster Cast Treatment|Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
274497|NCT01317160|O2|Outcome|Intermittent Pneumatic Compression (IPC)|"Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.~Intermittent pneumatic compression (IPC): 6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute."
274498|NCT01317160|O1|Outcome|Routine Care: Plaster Cast Treatment|Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
274499|NCT01317160|E2|Reported Event|Intermittent Pneumatic Compression (IPC)|"Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.~Intermittent pneumatic compression (IPC): 6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute."
274500|NCT01317160|E1|Reported Event|Routine Care: Plaster Cast Treatment|Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
274501|NCT01317095|B3|Baseline|Total|Total of all reporting groups
274502|NCT01317095|B2|Baseline|Rigid Fixation|"Patients will have their sternum closed by rigid fixation using Starnalock plates.~Sternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates."
274503|NCT01317095|B1|Baseline|Wire Closure is the Intervention|"Patients will have their sternum closed using stainless steel wires.~Sternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates."
274504|NCT01317095|P2|Participant Flow|Wire Closure is the Intervention|"Patients will have their sternum closed using stainless steel wires.~Sternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates."
274505|NCT01317095|P1|Participant Flow|Rigid Fixation|"Patients will have their sternum closed by rigid fixation using Starnalock plates.~Sternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates."
274506|NCT01317095|O2|Outcome|Wire Closure|Patients will have their sternum closed using stainless steel wires.
274507|NCT01317095|O1|Outcome|Rigid Fixation|Patients will have their sternum closed by rigid fixation using Starnalock plates.
274508|NCT01317095|O2|Outcome|Wire Closure|Patients will have their sternum closed using stainless steel wires.
274509|NCT01317095|O1|Outcome|Rigid Fixation|Patients will have their sternum closed by rigid fixation using Starnalock plates.
274510|NCT01317095|O2|Outcome|Wire Closure|Patients will have their sternum closed using stainless steel wires.
274511|NCT01317095|O1|Outcome|Rigid Fixation|Patients will have their sternum closed by rigid fixation using Starnalock plates.
274512|NCT01317095|O2|Outcome|Wire Closure|Patients will have their sternum closed using stainless steel wires.
274513|NCT01317095|O1|Outcome|Rigid Fixation|Patients will have their sternum closed by rigid fixation using Starnalock plates.
274514|NCT01317095|E2|Reported Event|Rigid Fixation|"Patients will have their sternum closed by rigid fixation using Starnalock plates.~Sternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates."
274515|NCT01317095|E1|Reported Event|Wire Closure is the Intervention|"Patients will have their sternum closed using stainless steel wires.~Sternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates."
274516|NCT01317004|B3|Baseline|Total|Total of all reporting groups
274517|NCT01317004|B2|Baseline|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
274518|NCT01317004|B1|Baseline|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
274519|NCT01317004|P2|Participant Flow|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
274520|NCT01317004|P1|Participant Flow|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
274521|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
306240|NCT01229228|P1|Participant Flow|Naproxen Test (Lower Dose)|
274524|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
274525|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
274526|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
274527|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
274528|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
274529|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
274530|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
274531|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
274532|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
274533|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
274534|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
274535|NCT01317004|E2|Reported Event|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
274536|NCT01317004|E1|Reported Event|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
274537|NCT01316939|B4|Baseline|Total|Total of all reporting groups
274538|NCT01316939|B3|Baseline|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
274539|NCT01316939|B2|Baseline|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274540|NCT01316939|B1|Baseline|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274541|NCT01316939|P3|Participant Flow|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules twice daily (BID).
274542|NCT01316939|P2|Participant Flow|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274543|NCT01316939|P1|Participant Flow|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 milligram (mg) capsules.
274544|NCT01316939|O3|Outcome|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
274545|NCT01316939|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274546|NCT01316939|O1|Outcome|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274547|NCT01316939|O3|Outcome|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
274548|NCT01316939|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274549|NCT01316939|O1|Outcome|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274550|NCT01316939|O3|Outcome|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
274551|NCT01316939|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274552|NCT01316939|O1|Outcome|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274553|NCT01316939|O3|Outcome|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
274554|NCT01316939|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274555|NCT01316939|O1|Outcome|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274556|NCT01316939|O3|Outcome|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
274557|NCT01316939|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274558|NCT01316939|O1|Outcome|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274559|NCT01316939|O3|Outcome|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
274560|NCT01316939|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274561|NCT01316939|O1|Outcome|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274562|NCT01316939|O3|Outcome|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
274563|NCT01316939|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274564|NCT01316939|O1|Outcome|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274565|NCT01316939|O3|Outcome|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
274566|NCT01316939|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274567|NCT01316939|O1|Outcome|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274568|NCT01316939|O3|Outcome|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
274569|NCT01316939|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274570|NCT01316939|O1|Outcome|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274571|NCT01316939|O3|Outcome|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
274572|NCT01316939|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274573|NCT01316939|O1|Outcome|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274574|NCT01316939|O3|Outcome|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
274575|NCT01316939|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274576|NCT01316939|O1|Outcome|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274577|NCT01316939|O3|Outcome|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
274578|NCT01316939|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274579|NCT01316939|O1|Outcome|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274580|NCT01316939|O3|Outcome|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
274581|NCT01316939|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274582|NCT01316939|O1|Outcome|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274583|NCT01316939|O3|Outcome|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
274584|NCT01316939|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274585|NCT01316939|O1|Outcome|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274586|NCT01316939|O3|Outcome|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
274587|NCT01316939|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274588|NCT01316939|O1|Outcome|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274589|NCT01316939|O3|Outcome|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
274590|NCT01316939|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274591|NCT01316939|O1|Outcome|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274592|NCT01316939|O3|Outcome|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
274593|NCT01316939|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274594|NCT01316939|O1|Outcome|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274595|NCT01316939|O3|Outcome|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
274596|NCT01316939|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274597|NCT01316939|O1|Outcome|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274598|NCT01316939|O3|Outcome|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
274599|NCT01316939|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274600|NCT01316939|O1|Outcome|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274601|NCT01316939|O3|Outcome|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
306241|NCT01229228|O5|Outcome|Placebo|
274602|NCT01316939|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274603|NCT01316939|O1|Outcome|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274604|NCT01316939|O3|Outcome|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
274605|NCT01316939|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274606|NCT01316939|O1|Outcome|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274607|NCT01316939|O3|Outcome|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
274608|NCT01316939|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274609|NCT01316939|O1|Outcome|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274610|NCT01316939|O3|Outcome|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
274611|NCT01316939|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274612|NCT01316939|O1|Outcome|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274613|NCT01316939|O3|Outcome|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
274614|NCT01316939|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274615|NCT01316939|O1|Outcome|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274616|NCT01316939|O3|Outcome|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
274617|NCT01316939|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
274618|NCT01316939|O1|Outcome|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274619|NCT01316939|E3|Reported Event|GSK1605786A 500 mg BID|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules twice daily (BID).
274620|NCT01316939|E2|Reported Event|GSK1605786A 500 mg Once Daily|Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 milligram (mg) capsules once daily.
274621|NCT01316939|E1|Reported Event|Placebo|Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
274622|NCT01316926|B1|Baseline|Participants Receiving Both Test and Reference Product|Participants receiving either test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 1; followed by reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2 or reference product in period 1 and test product in period 2
274623|NCT01316926|P2|Participant Flow|Reference Product in Period 1; Test Product in Period 2|Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra in Period 1; followed by test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 2
274624|NCT01316926|P1|Participant Flow|Test Product in Period 1; Reference Product in Period 2|Test product: paroxetine hydrochloride tablet with controlled release (Paxil CR) 25 milligrams (mg), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 1; followed by reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2
274625|NCT01316926|O2|Outcome|Reference Product|Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods
274626|NCT01316926|O1|Outcome|Test Product|Test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods
274627|NCT01316926|O2|Outcome|Reference Product|Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods
274628|NCT01316926|O1|Outcome|Test Product|Test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods
274629|NCT01316926|O2|Outcome|Reference Product|Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra in both periods
274630|NCT01316926|O1|Outcome|Test Product|Test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods
274631|NCT01316926|E2|Reported Event|Period 2|Participants receiving test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2
274632|NCT01316926|E1|Reported Event|Period 1|Participants receiving test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 1
274633|NCT01316913|B5|Baseline|Total|Total of all reporting groups
274634|NCT01316913|B4|Baseline|TIO18 µg QD|Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
274635|NCT01316913|B3|Baseline|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
274636|NCT01316913|B2|Baseline|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
306242|NCT01229228|O4|Outcome|Naprosyn 500 mg|
274637|NCT01316913|B1|Baseline|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
274638|NCT01316913|P4|Participant Flow|TIO18 µg QD|Participants received tiotropium bromide (TIO) 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
274639|NCT01316913|P3|Participant Flow|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
274640|NCT01316913|P2|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
274641|NCT01316913|P1|Participant Flow|UMEC 125 µg QD|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI) and placebo QD via a HandiHaler in the morning for 24 weeks.
274642|NCT01316913|O4|Outcome|TIO18 µg QD|Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
274643|NCT01316913|O3|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
274644|NCT01316913|O2|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
274645|NCT01316913|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
274646|NCT01316913|O4|Outcome|TIO18 µg QD|Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
274647|NCT01316913|O3|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
274648|NCT01316913|O2|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
274649|NCT01316913|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
274650|NCT01316913|O4|Outcome|TIO18 µg QD|Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
274651|NCT01316913|O3|Outcome|UMEC/VI 125/25 QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
274652|NCT01316913|O2|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
274653|NCT01316913|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
274654|NCT01316913|E4|Reported Event|TIO18 µg QD|Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
274655|NCT01316913|E3|Reported Event|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
274656|NCT01316913|E2|Reported Event|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
274657|NCT01316913|E1|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
274658|NCT01316900|B5|Baseline|Total|Total of all reporting groups
274659|NCT01316900|B4|Baseline|Tiotropium 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
274660|NCT01316900|B3|Baseline|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
274661|NCT01316900|B2|Baseline|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
274662|NCT01316900|B1|Baseline|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
274663|NCT01316900|P4|Participant Flow|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
274664|NCT01316900|P3|Participant Flow|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
274665|NCT01316900|P2|Participant Flow|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
274666|NCT01316900|P1|Participant Flow|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
274667|NCT01316900|O4|Outcome|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
274668|NCT01316900|O3|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
274669|NCT01316900|O2|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
274670|NCT01316900|O1|Outcome|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
274671|NCT01316900|O4|Outcome|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
274672|NCT01316900|O3|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
274673|NCT01316900|O2|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
274674|NCT01316900|O1|Outcome|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
274675|NCT01316900|O4|Outcome|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
274676|NCT01316900|O3|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
306243|NCT01229228|O3|Outcome|Naprosyn 250 mg|
274677|NCT01316900|O2|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
274678|NCT01316900|O1|Outcome|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
274679|NCT01316900|E4|Reported Event|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
274680|NCT01316900|E3|Reported Event|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
274681|NCT01316900|E2|Reported Event|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
274682|NCT01316900|E1|Reported Event|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
274683|NCT01316887|B4|Baseline|Total|Total of all reporting groups
274684|NCT01316887|B3|Baseline|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
274685|NCT01316887|B2|Baseline|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
274686|NCT01316887|B1|Baseline|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
274687|NCT01316887|P3|Participant Flow|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
274688|NCT01316887|P2|Participant Flow|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
274689|NCT01316887|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
274690|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
274691|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
274692|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
274693|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
274694|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
274695|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
274696|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
274697|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
274698|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
274699|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
274700|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
274701|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
274702|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
274703|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
274704|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
274705|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
274706|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
274707|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
274708|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
274709|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
274710|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
274711|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
274712|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
274713|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
274714|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
274715|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
274716|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
274717|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
274718|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
275024|NCT01316042|E1|Reported Event|Sugar Pill|2 pills per day for 12 months
274719|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
274720|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
274721|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
274722|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
274723|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
274724|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
274725|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
274726|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
274727|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
274728|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
274729|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
274730|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
274731|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
274732|NCT01316887|O3|Outcome|UMEC/VI 125/25µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
274733|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
274734|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
274735|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
274736|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
274737|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
274738|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
274739|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
274740|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
274741|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
274742|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
274743|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
274744|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
274745|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
274746|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
274747|NCT01316887|E3|Reported Event|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
274748|NCT01316887|E2|Reported Event|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
274749|NCT01316887|E1|Reported Event|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.ve
274750|NCT01316692|B1|Baseline|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
274751|NCT01316692|P1|Participant Flow|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
274752|NCT01316692|O1|Outcome|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
274753|NCT01316692|O1|Outcome|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
274862|NCT01316341|O3|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
274754|NCT01316692|O1|Outcome|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
274755|NCT01316692|O1|Outcome|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
274756|NCT01316692|O1|Outcome|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
274757|NCT01316692|O1|Outcome|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
274758|NCT01316692|E1|Reported Event|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
274759|NCT01316614|B1|Baseline|With Stylet & Without Stylet|There will only be one arm in this study. This arm will undergo EUS-guided FNA with the use of a stylet for half of their FNA passes and without a stylet for the other half. Patients will be exposed to an equal number of passes with and without a stylet.
274760|NCT01316614|P1|Participant Flow|With Stylet & Without Stylet|There will only be one arm in this study. This arm will undergo EUS-guided FNA with the use of a stylet for half of their FNA passes and without a stylet for the other half. Patients will be exposed to an equal number of passes with and without a stylet. Only the order of the passes were randomized.
274761|NCT01316614|O2|Outcome|Without Stylet|Each participant had half of their passes performed without a stylet.
274762|NCT01316614|O1|Outcome|With Stylet|Each participant had half of their passes performed with a stylet.
274763|NCT01316614|O2|Outcome|Without Stylet|Each participant had half of their passes performed without a stylet.
274764|NCT01316614|O1|Outcome|With Stylet|Each participant had half of their passes performed with a stylet.
274765|NCT01316614|O2|Outcome|Without Stylet|Each participant had half of their passes performed without a stylet.
274766|NCT01316614|O1|Outcome|With Stylet|Each participant had half of their passes performed with a stylet.
274767|NCT01316614|O2|Outcome|Without Stylet|Each participant had half of their passes performed without a stylet.
274768|NCT01316614|O1|Outcome|With Stylet|Each participant had half of their passes performed with a stylet.
274769|NCT01316614|O2|Outcome|Without Stylet|Each participant had half of their passes performed without a stylet.
274770|NCT01316614|O1|Outcome|With Stylet|Each participant had half of their passes performed with a stylet.
274771|NCT01316614|O2|Outcome|Without Stylet|Each participant had half of their passes performed without a stylet.
274772|NCT01316614|O1|Outcome|With Stylet|Each participant had half of their passes performed with a stylet.
274773|NCT01316614|E1|Reported Event|With Stylet & Without Stylet|There will only be one arm in this study. This arm will undergo EUS-guided FNA with the use of a stylet for half of their FNA passes and without a stylet for the other half. Patients will be exposed to an equal number of passes with and without a stylet.
274774|NCT01316575|B3|Baseline|Total|Total of all reporting groups
274775|NCT01316575|B2|Baseline|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
274776|NCT01316575|B1|Baseline|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
274777|NCT01316575|P2|Participant Flow|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
274778|NCT01316575|P1|Participant Flow|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
274779|NCT01316575|O2|Outcome|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
274780|NCT01316575|O1|Outcome|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
274781|NCT01316575|O2|Outcome|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
274782|NCT01316575|O1|Outcome|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
274783|NCT01316575|O2|Outcome|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
274784|NCT01316575|O1|Outcome|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
274785|NCT01316575|O2|Outcome|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
274786|NCT01316575|O1|Outcome|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
274787|NCT01316575|E2|Reported Event|Low Flow Oxygen|
274788|NCT01316575|E1|Reported Event|nCPAP|
274789|NCT01316419|B1|Baseline|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
274790|NCT01316419|P1|Participant Flow|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
274791|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
274792|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
274793|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
274794|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
274795|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
274796|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
274797|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
274798|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
274799|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
274800|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
274801|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
274802|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
274803|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
274804|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
274805|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
274806|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
274807|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
274808|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
274809|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
274949|NCT01316302|O1|Outcome|Pristiq|Flexible dose, 50-100mg QD
274950|NCT01316302|O2|Outcome|Placebo|"Matching placebo~Placebo: Matching placebo, taken QD for 12 weeks."
274810|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
274811|NCT01316419|E1|Reported Event|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
274812|NCT01316380|B4|Baseline|Total|Total of all reporting groups
274813|NCT01316380|B3|Baseline|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
274814|NCT01316380|B2|Baseline|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
274815|NCT01316380|B1|Baseline|Placebo|Patients treated with matching placebo
274816|NCT01316380|P3|Participant Flow|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
274817|NCT01316380|P2|Participant Flow|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
274818|NCT01316380|P1|Participant Flow|Placebo|Patients treated with matching placebo
274819|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
274820|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
274821|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
274822|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
274823|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
274824|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
274825|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
274826|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
274827|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
274828|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
274829|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
274830|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
274831|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
274832|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
274833|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
274834|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
274835|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
274836|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
274837|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
274838|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
274839|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
274840|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
274841|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
274842|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
274843|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
274844|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
274845|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
274846|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
274847|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
274848|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
274849|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
274850|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
274851|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
274852|NCT01316380|E3|Reported Event|Tio R5|Enter description here, if needed
274853|NCT01316380|E2|Reported Event|Tio R2.5|Enter description here, if needed
274854|NCT01316380|E1|Reported Event|Placebo|Enter description here, if needed
274855|NCT01316341|B4|Baseline|Total|Total of all reporting groups
274856|NCT01316341|B3|Baseline|Empa 25 mg|25 mg Empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 10mg empa tablet was taken at each drug administration.
274857|NCT01316341|B2|Baseline|Empa 10 mg|10 mg Empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 25mg empa tablet was taken at each drug administration.
274858|NCT01316341|B1|Baseline|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period).
274859|NCT01316341|P3|Participant Flow|Empa 25 mg|25 mg Empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 10mg empa tablet was taken at each drug administration.
274860|NCT01316341|P2|Participant Flow|Empa 10 mg|10 mg Empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 25mg empa tablet was taken at each drug administration.
274861|NCT01316341|P1|Participant Flow|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period).
274863|NCT01316341|O2|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
274864|NCT01316341|O1|Outcome|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally for 7 consecutive days.
274865|NCT01316341|O3|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
274866|NCT01316341|O2|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
274867|NCT01316341|O1|Outcome|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally for 7 consecutive days.
274868|NCT01316341|O3|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 10mg empa tablet was taken at each drug administration.
274869|NCT01316341|O2|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 25mg empa tablet was taken at each drug administration.
274870|NCT01316341|O1|Outcome|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period).
274871|NCT01316341|O2|Outcome|Empa 25 mg|A single dose of 25 mg empagliflozin (empa) taken orally, plus one placebo tablet.
274872|NCT01316341|O1|Outcome|Empa 10 mg|A single dose of 10 mg Empagliflozin (empa) taken orally, plus one placebo tablet.
274873|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
274874|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
274875|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
274876|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
274877|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
274878|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
274879|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
274880|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
274881|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
274882|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
274883|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
274884|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
274885|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
274886|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
274887|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
274888|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
274889|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
274890|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
274891|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
274892|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
274893|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
274894|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
274895|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
274896|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
274951|NCT01316302|O1|Outcome|Pristiq|"Flexible dose, 50-100mg QD~Pristiq: Flexible dose, 50-100mg QD, for 12 weeks."
274897|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
274898|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
274899|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
274900|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
274901|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
274902|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
274903|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
274904|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
274905|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
274906|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
274907|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
274908|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
274909|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
274910|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
274911|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
274912|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
274913|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
274914|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
274915|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
274916|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
274917|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
274918|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
274919|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
274920|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
274921|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
274922|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
274923|NCT01316341|E3|Reported Event|Empa 25 mg|25 mg empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 10mg empa tablet was taken at each drug administration.
274924|NCT01316341|E2|Reported Event|Empa 10 mg|10 mg empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 25mg empa tablet was taken at each drug administration.
274925|NCT01316341|E1|Reported Event|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period).
274926|NCT01316315|B3|Baseline|Total|Total of all reporting groups
274927|NCT01316315|B2|Baseline|Placebo|Non-Active
274928|NCT01316315|B1|Baseline|Active|N6022 - 5 mg
274929|NCT01316315|P2|Participant Flow|Placebo|Non-Active
274930|NCT01316315|P1|Participant Flow|Active|N6022 - Active 5 mg
274931|NCT01316315|O2|Outcome|Placebo|Non-Active
274932|NCT01316315|O1|Outcome|Active|N6022 - Active 5 mg
274933|NCT01316315|O2|Outcome|Placebo|Non-Active
274934|NCT01316315|O1|Outcome|Active|N6022 - Active 5 mg
274935|NCT01316315|O2|Outcome|Placebo|Non-Active
274936|NCT01316315|O1|Outcome|Active|N6022 - Active 5 mg
274937|NCT01316315|O2|Outcome|Placebo|Patients received a single IV administration of 5 mL of placebo on Day 1 in each treatment period and single dose of N6022 on the day 1 of the second period.
274938|NCT01316315|O1|Outcome|N6022|Patients received a single IV administration of 5 mL of N6022 on Day 1 in each treatment period and single dose of placebo on Day 1 of the second period.
274939|NCT01316315|E2|Reported Event|Placebo|Non-Active
274940|NCT01316315|E1|Reported Event|Active|N6022 - Active 5 mg
274941|NCT01316302|B3|Baseline|Total|Total of all reporting groups
274942|NCT01316302|B2|Baseline|Placebo|"Matching placebo~Placebo: Matching placebo, taken QD for 12 weeks."
274943|NCT01316302|B1|Baseline|Pristiq|"Flexible dose, 50-100mg QD~Pristiq: Flexible dose, 50-100mg QD, for 12 weeks."
274944|NCT01316302|P2|Participant Flow|Placebo|"Matching placebo~Placebo: Matching placebo, taken QD for 12 weeks."
274945|NCT01316302|P1|Participant Flow|Pristiq|"Flexible dose, 50-100mg QD~Pristiq: Flexible dose, 50-100mg QD, for 12 weeks."
274946|NCT01316302|O2|Outcome|Placebo|Matching placebo
274947|NCT01316302|O1|Outcome|Pristiq|Flexible dose, 50-100mg QD
274948|NCT01316302|O2|Outcome|Placebo|Matching placebo
274952|NCT01316302|E2|Reported Event|Placebo|"Matching placebo~Placebo: Matching placebo, taken QD for 12 weeks."
274953|NCT01316302|E1|Reported Event|Pristiq|"Flexible dose, 50-100mg QD~Pristiq: Flexible dose, 50-100mg QD, for 12 weeks."
274954|NCT01316263|B3|Baseline|Total|Total of all reporting groups
274955|NCT01316263|B2|Baseline|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
274956|NCT01316263|B1|Baseline|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
274957|NCT01316263|P2|Participant Flow|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
274958|NCT01316263|P1|Participant Flow|PDGFRα Mutation Positive|20 milligrams per kilogram (mg/kg) of Olaratumab (IMC-3G3) was administered intravenously (IV) on Day 1 of each cycle (14-day cycles) to participants with gastrointestinal stromal tumors (GIST) with genotypes that had a platelet-derived growth factor receptor alpha (PDGFRα) mutation.
274959|NCT01316263|O1|Outcome|PDGFRα Mutation Positive and Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation and that did not have a PDGFRα mutation.
274960|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
274961|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
274962|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
274963|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
274964|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
274965|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
274966|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
274967|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
274968|NCT01316263|O1|Outcome|Olaratumab (IMC-3G3)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation or PDGFRα wild type.
274969|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
274970|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
274971|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
274972|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
274973|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
274974|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
274975|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
274976|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
274977|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
274978|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
274979|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
274980|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
274981|NCT01316263|E2|Reported Event|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
274982|NCT01316263|E1|Reported Event|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
274983|NCT01316224|B1|Baseline|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
274984|NCT01316224|P1|Participant Flow|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
274985|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
274986|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
274987|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
274988|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
274989|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
274990|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
274991|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
274992|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
274993|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
274994|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
274995|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
274996|NCT01316224|E1|Reported Event|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with Adalimumab
274997|NCT01316055|B4|Baseline|Total|Total of all reporting groups
274998|NCT01316055|B3|Baseline|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
274999|NCT01316055|B2|Baseline|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
275000|NCT01316055|B1|Baseline|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
275001|NCT01316055|P3|Participant Flow|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
275002|NCT01316055|P2|Participant Flow|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
275003|NCT01316055|P1|Participant Flow|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
275004|NCT01316055|O3|Outcome|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg steady-state dosing in volunteers with moderate renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
275005|NCT01316055|O2|Outcome|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg and steady-state dosing in volunteers with mild renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
275006|NCT01316055|O1|Outcome|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg steady-state dosing in healthy volunteers~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
275007|NCT01316055|O3|Outcome|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
275008|NCT01316055|O2|Outcome|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
275009|NCT01316055|O1|Outcome|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
275010|NCT01316055|O3|Outcome|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
275011|NCT01316055|O2|Outcome|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
275012|NCT01316055|O1|Outcome|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
275013|NCT01316055|E3|Reported Event|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
275014|NCT01316055|E2|Reported Event|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
275015|NCT01316055|E1|Reported Event|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
275016|NCT01316042|B3|Baseline|Total|Total of all reporting groups
275017|NCT01316042|B2|Baseline|Metformin|2 212.5mg pill/day for 12 months
275018|NCT01316042|B1|Baseline|Sugar Pill|2 pills per day for 12 months
275019|NCT01316042|P2|Participant Flow|Metformin|2 212.5mg pill/day for 12 months
275020|NCT01316042|P1|Participant Flow|Sugar Pill|2 pills per day for 12 months
275021|NCT01316042|O2|Outcome|Metformin|2 212.5mg pill/day for 12 months
275022|NCT01316042|O1|Outcome|Sugar Pill|2 pills per day for 12 months
275023|NCT01316042|E2|Reported Event|Metformin|2 212.5mg pill/day for 12 months
275025|NCT01315873|B1|Baseline|Bortezomib and Bendamustine|"Bendamustine: On days 1 and 4 of each cycle, bendamustine is given at 90 mg/m^2 after bortezomib . Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.~Patients will be treated until disease progression after at least one cycle of treatment.~Bortezomib: On days 1 and 4 of each cycle, bortezomib is given first at 1.3 mg/m^2 followed by bendamustine given at 90 mg/m^2. Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.~Patients will be treated until disease progression after at least one cycle of treatment."
275026|NCT01315873|P1|Participant Flow|Bortezomib and Bendamustine|"Bendamustine: On days 1 and 4 of each cycle, bendamustine is given at 90 mg/m^2 after bortezomib . Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.~Patients will be treated until disease progression after at least one cycle of treatment.~Bortezomib: On days 1 and 4 of each cycle, bortezomib is given first at 1.3 mg/m^2 followed by bendamustine given at 90 mg/m^2. Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.~Patients will be treated until disease progression after at least one cycle of treatment."
275027|NCT01315873|O1|Outcome|Bortezomib and Bendamustine|"Bendamustine: On days 1 and 4 of each cycle, bendamustine is given at 90 mg/m^2 after bortezomib . Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.~Patients will be treated until disease progression after at least one cycle of treatment.~Bortezomib: On days 1 and 4 of each cycle, bortezomib is given first at 1.3 mg/m^2 followed by bendamustine given at 90 mg/m^2. Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.~Patients will be treated until disease progression after at least one cycle of treatment."
275028|NCT01315873|O1|Outcome|Bortezomib and Bendamustine|"Bendamustine: On days 1 and 4 of each cycle, bendamustine is given at 90 mg/m^2 after bortezomib . Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.~Patients will be treated until disease progression after at least one cycle of treatment.~Bortezomib: On days 1 and 4 of each cycle, bortezomib is given first at 1.3 mg/m^2 followed by bendamustine given at 90 mg/m^2. Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.~Patients will be treated until disease progression after at least one cycle of treatment."
275029|NCT01315873|O1|Outcome|Bortezomib and Bendamustine|"Bendamustine: On days 1 and 4 of each cycle, bendamustine is given at 90 mg/m^2 after bortezomib . Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.~Patients will be treated until disease progression after at least one cycle of treatment.~Bortezomib: On days 1 and 4 of each cycle, bortezomib is given first at 1.3 mg/m^2 followed by bendamustine given at 90 mg/m^2. Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.~Patients will be treated until disease progression after at least one cycle of treatment."
275030|NCT01315873|E1|Reported Event|Bortezomib and Bendamustine|"Bendamustine: On days 1 and 4 of each cycle, bendamustine is given at 90 mg/m^2 after bortezomib . Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.~Patients will be treated until disease progression after at least one cycle of treatment.~Bortezomib: On days 1 and 4 of each cycle, bortezomib is given first at 1.3 mg/m^2 followed by bendamustine given at 90 mg/m^2. Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.~Patients will be treated until disease progression after at least one cycle of treatment."
275031|NCT01315847|B3|Baseline|Total|Total of all reporting groups
275032|NCT01315847|B2|Baseline|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
275033|NCT01315847|B1|Baseline|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
275034|NCT01315847|P2|Participant Flow|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
275794|NCT01313650|O3|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
275035|NCT01315847|P1|Participant Flow|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline positron emission tomography (PET) imaging of the brain using [11C]MK-4232 tracer (~300 megabecquerel [MBq]) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
275036|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
275037|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
275038|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
275039|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
275040|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
275041|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
275042|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
275043|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
275070|NCT01315574|O2|Outcome|Travoprost (Travatan Z)|"7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.~Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
275071|NCT01315574|O1|Outcome|Latanoprost (Xalatan)|"7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.~Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
275629|NCT01313780|O2|Outcome|Oxycodone|Trade name is Oxycontin. Daily dose can be titrated up to 40mg B.I.D.
275044|NCT01315847|E2|Reported Event|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
275045|NCT01315847|E1|Reported Event|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
275046|NCT01315665|B3|Baseline|Total|Total of all reporting groups
275047|NCT01315665|B2|Baseline|Subjects With Cystic Fibrosis|"Subjects with cystic fibrosis~Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
275048|NCT01315665|B1|Baseline|Healthy Volunteers|"Healthy volunteers~Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
275049|NCT01315665|P2|Participant Flow|Subjects With Cystic Fibrosis|"Subjects with cystic fibrosis~Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
275050|NCT01315665|P1|Participant Flow|Healthy Volunteers|"Healthy volunteers~Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
275051|NCT01315665|O2|Outcome|Subjects With Cystic Fibrosis|"100 grams of raw broccoli sprouts once daily for 5 consecutive days~Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
275052|NCT01315665|O1|Outcome|Healthy Volunteers|"100 grams of raw broccoli sprouts once daily for 5 consecutive days~Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
275053|NCT01315665|O2|Outcome|Subjects With Cystic Fibrosis|"100 grams of raw broccoli sprouts once daily for 5 consecutive days~Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
275054|NCT01315665|O1|Outcome|Healthy Volunteers|"100 grams of raw broccoli sprouts once daily for 5 consecutive days~Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
275055|NCT01315665|O2|Outcome|Subjects With Cystic Fibrosis|"100 grams of raw broccoli sprouts once daily for 5 consecutive days~Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
275056|NCT01315665|O1|Outcome|Healthy Volunteers|"100 grams of raw broccoli sprouts once daily for 5 consecutive days~Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
275057|NCT01315665|O2|Outcome|Subjects With Cystic Fibrosis|"100 grams of raw broccoli sprouts once daily for 5 consecutive days~Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
275058|NCT01315665|O1|Outcome|Healthy Volunteers|"100 grams of raw broccoli sprouts once daily for 5 consecutive days~Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
275059|NCT01315665|O2|Outcome|Subjects With Cystic Fibrosis|"Subjects with cystic fibrosis~Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
275060|NCT01315665|O1|Outcome|Healthy Volunteers|"Healthy volunteers~Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
275061|NCT01315665|E2|Reported Event|Subjects With Cystic Fibrosis|"Subjects with cystic fibrosis~Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
275062|NCT01315665|E1|Reported Event|Healthy Volunteers|"Healthy volunteers~Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
275063|NCT01315574|B3|Baseline|Total|Total of all reporting groups
275064|NCT01315574|B2|Baseline|Travoprost (Travatan Z)|"7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.~Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
275065|NCT01315574|B1|Baseline|Latanoprost (Xalatan)|"7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.~Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
275066|NCT01315574|P2|Participant Flow|Travoprost (Travatan Z)|"7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.~Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
275067|NCT01315574|P1|Participant Flow|Latanoprost (Xalatan)|"7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.~Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
275068|NCT01315574|O2|Outcome|Travoprost (Travatan Z)|"7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.~Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
275069|NCT01315574|O1|Outcome|Latanoprost (Xalatan)|"7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.~Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
309233|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
275072|NCT01315574|O2|Outcome|Travoprost (Travatan Z)|"7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.~Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
275073|NCT01315574|O1|Outcome|Latanoprost (Xalatan)|"7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.~Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
275074|NCT01315574|E2|Reported Event|Travoprost (Travatan Z)|"7 Patients were be randomized to receive BAK-free Travatan Z for treatment of their glaucoma.~Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
275075|NCT01315574|E1|Reported Event|Latanoprost (Xalatan)|"7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.~Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
275076|NCT01315353|B4|Baseline|Total|Total of all reporting groups
275077|NCT01315353|B3|Baseline|Arm C : Ineligible for Randomization to Arm A or B|"Participants were eligible for Arm C under the conditions noted in the inclusion criteria. Participants in Arm C had colposcopy and directed biopsies at entry. If CIN2+ is found by biopsy, then LEEP was performed and a follow-up visit 26 weeks after these procedures was scheduled for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. After the week 26 visit, Arm C participants went off study.~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275078|NCT01315353|B2|Baseline|Arm B: Cytology-based Strategy|"Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed).~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275079|NCT01315353|B1|Baseline|Arm A: Immediate Cryotherapy (HPV Test-and-treat)|"Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP.~Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing.~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275080|NCT01315353|P3|Participant Flow|Arm C : Ineligible for Randomization to Arm A or B|"Participants were eligible for Arm C under the conditions noted in the inclusion criteria. Participants in Arm C had colposcopy and directed biopsies at entry. If CIN2+ is found by biopsy, then LEEP was performed and a follow-up visit 26 weeks after these procedures was scheduled for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. After the week 26 visit, Arm C participants went off study.~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275081|NCT01315353|P2|Participant Flow|Arm B: Cytology-based Strategy|"Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed).~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275082|NCT01315353|P1|Participant Flow|Arm A: Immediate Cryotherapy (HPV Test-and-treat)|"Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP.~Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing.~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275083|NCT01315353|O3|Outcome|Arm C : Ineligible for Randomization to Arm A or B|"Participants were eligible for Arm C under the conditions noted in the inclusion criteria. Participants in Arm C had colposcopy and directed biopsies at entry. If CIN2+ is found by biopsy, then LEEP was performed and a follow-up visit 26 weeks after these procedures was scheduled for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. After the week 26 visit, Arm C participants went off study.~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275084|NCT01315353|O2|Outcome|Arm B: Cytology-based Strategy|"Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed).~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275085|NCT01315353|O1|Outcome|Arm A: Immediate Cryotherapy (HPV Test-and-treat)|"Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP.~Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing.~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275086|NCT01315353|O1|Outcome|Arm A: Immediate Cryotherapy (HPV Test-and-treat)|"Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP.~Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing.~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275131|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
275870|NCT01313520|B1|Baseline|Infliximab|3 mg/kg of Infliximab intravenous infusion
275087|NCT01315353|O2|Outcome|Arm B: Cytology-based Strategy|"Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed).~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275088|NCT01315353|O1|Outcome|Arm A: Immediate Cryotherapy (HPV Test-and-treat)|"Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP.~Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing.~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275089|NCT01315353|O2|Outcome|Arm B: Cytology-based Strategy|"Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed).~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275090|NCT01315353|O1|Outcome|Arm A: Immediate Cryotherapy (HPV Test-and-treat)|"Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP.~Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing.~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275091|NCT01315353|O2|Outcome|Arm B: Cytology-based Strategy|"Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed).~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275092|NCT01315353|O1|Outcome|Arm A: Immediate Cryotherapy (HPV Test-and-treat)|"Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP.~Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing.~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275093|NCT01315353|O2|Outcome|Arm B: Cytology-based Strategy|"Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed).~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275094|NCT01315353|O1|Outcome|Arm A: Immediate Cryotherapy (HPV Test-and-treat)|"Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP.~Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing.~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275095|NCT01315353|O2|Outcome|Arm B: Cytology-based Strategy|"Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed).~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275096|NCT01315353|O1|Outcome|Arm A: Immediate Cryotherapy (HPV Test-and-treat)|"Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP.~Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing.~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275097|NCT01315353|O2|Outcome|Arm B: Cytology-based Strategy|"Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed).~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275098|NCT01315353|O1|Outcome|Arm A: Immediate Cryotherapy (HPV Test-and-treat)|"Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP.~Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing.~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275099|NCT01315353|O2|Outcome|Arm B: Cytology-based Strategy|"Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed).~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275132|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
275133|NCT01315249|E2|Reported Event|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
275134|NCT01315249|E1|Reported Event|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
275100|NCT01315353|O1|Outcome|Arm A: Immediate Cryotherapy (HPV Test-and-treat)|"Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP.~Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing.~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275101|NCT01315353|O2|Outcome|Arm B: Cytology-based Strategy|"Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed).~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275102|NCT01315353|O1|Outcome|Arm A: Immediate Cryotherapy (HPV Test-and-treat)|"Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP.~Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing.~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275103|NCT01315353|E3|Reported Event|Arm C: Ineligible for Randomization to Arm A or B|"Participants were eligible for Arm C under the conditions noted in the inclusion criteria. Participants in Arm C had colposcopy and directed biopsies at entry. If CIN2+ is found by biopsy, then LEEP was performed and a follow-up visit 26 weeks after these procedures was scheduled for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. After the week 26 visit, Arm C participants went off study.~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275104|NCT01315353|E2|Reported Event|Arm B: Cytology-based Strategy|"Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed).~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275105|NCT01315353|E1|Reported Event|Arm A: Immediate Cryotherapy (HPV Test-and-treat)|"Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP.~Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing.~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
275106|NCT01315249|B3|Baseline|Total|Total of all reporting groups
275107|NCT01315249|B2|Baseline|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
275108|NCT01315249|B1|Baseline|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
275109|NCT01315249|P2|Participant Flow|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
275110|NCT01315249|P1|Participant Flow|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
275111|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
275112|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
275113|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
275114|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
275115|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
275116|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
275117|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
275118|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
275119|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
275120|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
275121|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
275122|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
275123|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
275124|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
275125|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
275126|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
275127|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
275128|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
275129|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
275130|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
275136|NCT01315158|B2|Baseline|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
275137|NCT01315158|B1|Baseline|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
275138|NCT01315158|P2|Participant Flow|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
275139|NCT01315158|P1|Participant Flow|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
275140|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
275141|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
275142|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
275143|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
275144|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
275145|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
275146|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
275147|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
275148|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
275165|NCT01315145|O2|Outcome|Lumbar Epidural Steroid Injection|"Injection of epidural steroids into the lumbar spine~Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
275189|NCT01315002|E2|Reported Event|Placebo First, Then Nicotine|"Placebo patch first (single application), then transdermal nicotine patch (single application, one week after administration of placebo patch)~Doses:~non-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch"
275149|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
275150|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
275151|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
275152|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
275153|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
275154|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
275155|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
275156|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
275157|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
275158|NCT01315158|E2|Reported Event|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
275159|NCT01315158|E1|Reported Event|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
275160|NCT01315145|B3|Baseline|Total|Total of all reporting groups
275161|NCT01315145|B2|Baseline|Lumbar Epidural Steroid Injection|"Injection of epidural steroids into the lumbar spine~Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
275162|NCT01315145|B1|Baseline|Percutaneous Lumbar Decompression|"Patients receiving percutaneous decompression using the mild® Device Kit.~Percutaneous Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
275163|NCT01315145|P2|Participant Flow|Lumbar Epidural Steroid Injection|"Injection of epidural steroids into the lumbar spine~Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
275164|NCT01315145|P1|Participant Flow|Percutaneous Lumbar Decompression|"Patients receiving percutaneous decompression using the mild® Device Kit.~Percutaneous Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
309234|NCT01222520|O2|Outcome|Telmisartan|
275166|NCT01315145|O1|Outcome|Percutaneous Lumbar Decompression|"Patients receiving percutaneous decompression using the mild® Device Kit.~Percutaneous Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
275167|NCT01315145|E2|Reported Event|Lumbar Epidural Steroid Injection|"Injection of epidural steroids into the lumbar spine~Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
275168|NCT01315145|E1|Reported Event|Percutaneous Lumbar Decompression|"Patients receiving percutaneous decompression using the mild® Device Kit.~Percutaneous Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
275169|NCT01315028|B3|Baseline|Total|Total of all reporting groups
275170|NCT01315028|B2|Baseline|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
275171|NCT01315028|B1|Baseline|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
275172|NCT01315028|P2|Participant Flow|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
275173|NCT01315028|P1|Participant Flow|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
275174|NCT01315028|O2|Outcome|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
275175|NCT01315028|O1|Outcome|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
275176|NCT01315028|O2|Outcome|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
275177|NCT01315028|O1|Outcome|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
275178|NCT01315028|O2|Outcome|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
275179|NCT01315028|O1|Outcome|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
275180|NCT01315028|O2|Outcome|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
275181|NCT01315028|O1|Outcome|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
275182|NCT01315028|E2|Reported Event|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
275183|NCT01315028|E1|Reported Event|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
275184|NCT01315002|B1|Baseline|All Study Participants|Includes groups randomized to receive nicotine first and placebo first. Number of all study participants = 121.
275185|NCT01315002|P2|Participant Flow|Placebo First, Then Nicotine|"Placebo patch first (single application), then transdermal nicotine patch (single application, one week after administration of placebo patch)~Doses:~non-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch"
275186|NCT01315002|P1|Participant Flow|Nicotine First, Then Placebo|"Transdermal nicotine patch first (single application), then placebo patch (single application, one week after administration of nicotine patch)~Doses:~non-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch"
275187|NCT01315002|O2|Outcome|Placebo Patch|"Placebo patch~Placebo patch: Placebo patch"
275188|NCT01315002|O1|Outcome|Nicotine Patch|"Transdermal nicotine patch~Transdermal nicotine patch: 7mg transdermal nicotine patch (non-smoking subjects) 14mg transdermal nicotine patch (smoking subjects)"
309235|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
275190|NCT01315002|E1|Reported Event|Nicotine First, Then Placebo|"Transdermal nicotine patch first (single application), then placebo patch (single application, one week after administration of nicotine patch)~Doses:~non-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch"
275191|NCT01314963|B1|Baseline|All Participants|This study evaluates the ability of 2 procedures to detect sentinel lymph nodes (SLNs), and does not evaluate between groups of participants.
275192|NCT01314963|P1|Participant Flow|All Participants|This study evaluates the ability of 2 procedures to detect sentinel lymph nodes (SLNs), and does not evaluate between groups of participants.
275193|NCT01314963|O2|Outcome|Gamma Probes (GP)|"Lymphoscintigraphy with standard of care intraoperative gamma probes (GP)~radioactive Tc99M: Lymphoscintigraphy involves injection of 0.4 to 1.0 mCi of radioactive Tc99M sulfur colloid around at the tumor site."
275194|NCT01314963|O1|Outcome|Intraoperative Handheld Gamma Camera (pIHGC)|"The prototype intraoperative handheld gamma camera (pIHGC)~radioactive Tc99M: Lymphoscintigraphy involves injection of 0.4 to 1.0 mCi of radioactive Tc99M sulfur colloid around at the tumor site."
275195|NCT01314963|E2|Reported Event|All Participants - Gamma Probes (GP)|The entire set of sentinel lymph nodes (SLNs) excised from study participants (ie, all participants) were evaluated with the gamma probes (GP).
275196|NCT01314963|E1|Reported Event|All Participants - Intraoperative Handheld Gamma Camera (pIHGC|The entire set of sentinel lymph nodes (SLNs) excised from study participants (ie, all participants) were evaluated with the intraoperative handheld gamma camera (pIHGC).
275197|NCT01314872|B12|Baseline|Total|Total of all reporting groups
275198|NCT01314872|B11|Baseline|Part 2: Vibegron 100 mg + Tolterodine ER 4 mg|Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
275199|NCT01314872|B10|Baseline|Part 2: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
275200|NCT01314872|B9|Baseline|Part 2: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
275201|NCT01314872|B8|Baseline|Part 2: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
275202|NCT01314872|B7|Baseline|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
275203|NCT01314872|B6|Baseline|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
275204|NCT01314872|B5|Baseline|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275205|NCT01314872|B4|Baseline|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275206|NCT01314872|B3|Baseline|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275207|NCT01314872|B2|Baseline|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275208|NCT01314872|B1|Baseline|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
275209|NCT01314872|P15|Participant Flow|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
275210|NCT01314872|P14|Participant Flow|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
275211|NCT01314872|P13|Participant Flow|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
275212|NCT01314872|P12|Participant Flow|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
275213|NCT01314872|P11|Participant Flow|Part 2: Vibegron 100 mg + Tolterodine ER 4 mg|Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
275214|NCT01314872|P10|Participant Flow|Part 2: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
275215|NCT01314872|P9|Participant Flow|Part 2: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
275216|NCT01314872|P8|Participant Flow|Part 2: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
275217|NCT01314872|P7|Participant Flow|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
275218|NCT01314872|P6|Participant Flow|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
275219|NCT01314872|P5|Participant Flow|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275220|NCT01314872|P4|Participant Flow|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275221|NCT01314872|P3|Participant Flow|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275222|NCT01314872|P2|Participant Flow|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275223|NCT01314872|P1|Participant Flow|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
275224|NCT01314872|O4|Outcome|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
275225|NCT01314872|O3|Outcome|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
275226|NCT01314872|O2|Outcome|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
275227|NCT01314872|O1|Outcome|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
275228|NCT01314872|O4|Outcome|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
275229|NCT01314872|O3|Outcome|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
275230|NCT01314872|O2|Outcome|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
275231|NCT01314872|O1|Outcome|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
275232|NCT01314872|O4|Outcome|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
275233|NCT01314872|O3|Outcome|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
275234|NCT01314872|O2|Outcome|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
275235|NCT01314872|O1|Outcome|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
275236|NCT01314872|O4|Outcome|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
275237|NCT01314872|O3|Outcome|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
275238|NCT01314872|O2|Outcome|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
275239|NCT01314872|O1|Outcome|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
275240|NCT01314872|O7|Outcome|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
275241|NCT01314872|O6|Outcome|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
275242|NCT01314872|O5|Outcome|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275243|NCT01314872|O4|Outcome|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275244|NCT01314872|O3|Outcome|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275245|NCT01314872|O2|Outcome|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275246|NCT01314872|O1|Outcome|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
275247|NCT01314872|O7|Outcome|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
275248|NCT01314872|O6|Outcome|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
275249|NCT01314872|O5|Outcome|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275250|NCT01314872|O4|Outcome|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275251|NCT01314872|O3|Outcome|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275252|NCT01314872|O2|Outcome|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275253|NCT01314872|O1|Outcome|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
275254|NCT01314872|O7|Outcome|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
275255|NCT01314872|O6|Outcome|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
275256|NCT01314872|O5|Outcome|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275257|NCT01314872|O4|Outcome|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275630|NCT01313780|O1|Outcome|Oxycodone and Naloxone|Trade name is TARGIN. Daily dose can be titrated up to 40mg B.I.D.
275258|NCT01314872|O3|Outcome|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275259|NCT01314872|O2|Outcome|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275260|NCT01314872|O1|Outcome|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
275261|NCT01314872|O4|Outcome|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
275262|NCT01314872|O3|Outcome|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
275263|NCT01314872|O2|Outcome|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
275264|NCT01314872|O1|Outcome|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
275265|NCT01314872|O4|Outcome|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
275266|NCT01314872|O3|Outcome|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
275267|NCT01314872|O2|Outcome|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
275268|NCT01314872|O1|Outcome|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
275269|NCT01314872|O11|Outcome|Part 2: Vibegron 100 mg + Tolterodine ER 4 mg|Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
275270|NCT01314872|O10|Outcome|Part 2: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
275271|NCT01314872|O9|Outcome|Part 2: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
275272|NCT01314872|O8|Outcome|Part 2: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
275273|NCT01314872|O7|Outcome|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
275274|NCT01314872|O6|Outcome|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
275275|NCT01314872|O5|Outcome|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275276|NCT01314872|O4|Outcome|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275277|NCT01314872|O3|Outcome|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275278|NCT01314872|O2|Outcome|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275279|NCT01314872|O1|Outcome|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
275280|NCT01314872|O11|Outcome|Part 2: Vibegron 100 mg + Tolterodine ER 4 mg|Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
275281|NCT01314872|O10|Outcome|Part 2: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
275282|NCT01314872|O9|Outcome|Part 2: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
275283|NCT01314872|O8|Outcome|Part 2: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
275284|NCT01314872|O7|Outcome|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
275285|NCT01314872|O6|Outcome|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
275286|NCT01314872|O5|Outcome|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275287|NCT01314872|O4|Outcome|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275288|NCT01314872|O3|Outcome|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275289|NCT01314872|O2|Outcome|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275290|NCT01314872|O1|Outcome|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
275291|NCT01314872|O7|Outcome|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
275292|NCT01314872|O6|Outcome|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
275293|NCT01314872|O5|Outcome|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275294|NCT01314872|O4|Outcome|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275295|NCT01314872|O3|Outcome|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275296|NCT01314872|O2|Outcome|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275297|NCT01314872|O1|Outcome|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
275298|NCT01314872|E15|Reported Event|Extension Study: Vibegron 50 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
275299|NCT01314872|E14|Reported Event|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
275300|NCT01314872|E13|Reported Event|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
275301|NCT01314872|E12|Reported Event|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
275302|NCT01314872|E11|Reported Event|Part 2: Vibegron 100 mg + Tolterodine ER 4 mg|Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
275303|NCT01314872|E10|Reported Event|Part 2: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
275304|NCT01314872|E9|Reported Event|Part 2: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
275305|NCT01314872|E8|Reported Event|Part 2: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
275631|NCT01313780|O2|Outcome|Oxycodone|Trade name is Oxycontin. Daily dose can be titrated up to 40mg B.I.D.
275306|NCT01314872|E7|Reported Event|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
275307|NCT01314872|E6|Reported Event|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
275308|NCT01314872|E5|Reported Event|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275309|NCT01314872|E4|Reported Event|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275310|NCT01314872|E3|Reported Event|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275311|NCT01314872|E2|Reported Event|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
275312|NCT01314872|E1|Reported Event|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
275313|NCT01314742|B3|Baseline|Total|Total of all reporting groups
275314|NCT01314742|B2|Baseline|Sterile Water Arm|Sterile Water moisten cotton tipped applicator : One oral care application will be performed every 4 hours, or at touch times, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization.
275315|NCT01314742|B1|Baseline|Biotene OralBalance® Gel Arm|"Biotene OralBalance® gel contains antibacterial active ingredients: lactoperoxidase, lysozyme and lactoferrin. These enzymes occur naturally in the human milk and colostrum and have mimicking properties of the human saliva activity in vivo.~Biotene OralBalance® gel : Biotene OralBalance® gel is dispensed as 42gm, patient specific tube from hospital's Central Pharmacy. One pea-size oral application every 4 hours, or at touch time, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization."
275316|NCT01314742|P2|Participant Flow|Sterile Water Arm|Sterile Water moisten cotton tipped applicator : One oral care application will be performed every 4 hours, or at touch times, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization.
275317|NCT01314742|P1|Participant Flow|Biotene OralBalance® Gel Arm|"Biotene OralBalance® gel contains antibacterial active ingredients: lactoperoxidase, lysozyme and lactoferrin. These enzymes occur naturally in the human milk and colostrum and have mimicking properties of the human saliva activity in vivo.~Biotene OralBalance® gel : Biotene OralBalance® gel is dispensed as 42gm, patient specific tube from hospital's Central Pharmacy. One pea-size oral application every 4 hours, or at touch time, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization."
275318|NCT01314742|O2|Outcome|Sterile Water Arm|Sterile Water moisten cotton tipped applicator : One oral care application will be performed every 4 hours, or at touch times, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization.
275319|NCT01314742|O1|Outcome|Biotene OralBalance® Gel Arm|"Biotene OralBalance® gel contains antibacterial active ingredients: lactoperoxidase, lysozyme and lactoferrin. These enzymes occur naturally in the human milk and colostrum and have mimicking properties of the human saliva activity in vivo.~Biotene OralBalance® gel : Biotene OralBalance® gel is dispensed as 42gm, patient specific tube from hospital's Central Pharmacy. One pea-size oral application every 4 hours, or at touch time, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization."
275320|NCT01314742|O2|Outcome|Sterile Water Group|Study group receiving timed oral care with Sterile Water
275321|NCT01314742|O1|Outcome|Biotene OralBalance® Gel Arm|Study group receiving timed oral care with Biotene OralBalance® gel Arm
275322|NCT01314742|E2|Reported Event|Sterile Water Arm|Sterile Water moisten cotton tipped applicator : One oral care application will be performed every 4 hours, or at touch times, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization.
275323|NCT01314742|E1|Reported Event|Biotene OralBalance® Gel Arm|"Biotene OralBalance® gel contains antibacterial active ingredients: lactoperoxidase, lysozyme and lactoferrin. These enzymes occur naturally in the human milk and colostrum and have mimicking properties of the human saliva activity in vivo.~Biotene OralBalance® gel : Biotene OralBalance® gel is dispensed as 42gm, patient specific tube from hospital's Central Pharmacy. One pea-size oral application every 4 hours, or at touch time, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization."
275324|NCT01314716|B3|Baseline|Total|Total of all reporting groups
275325|NCT01314716|B2|Baseline|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
275326|NCT01314716|B1|Baseline|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
275327|NCT01314716|P2|Participant Flow|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 84 days.
275328|NCT01314716|P1|Participant Flow|AZLI-AZLI|Participants were randomized to receive blinded Aztreonam for Inhalation Solution (AZLI) 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 84 days.
275357|NCT01314443|O4|Outcome|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
309236|NCT01222520|E2|Reported Event|Telmisartan|
275329|NCT01314716|O2|Outcome|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
275330|NCT01314716|O1|Outcome|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
275331|NCT01314716|O2|Outcome|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
275332|NCT01314716|O1|Outcome|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
275333|NCT01314716|O2|Outcome|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
275334|NCT01314716|O1|Outcome|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
275335|NCT01314716|E4|Reported Event|Placebo-AZLI (Open-Label)|Adverse events for this reporting group were reported from Day 112 to Day 196 plus 30 days while participants were receiving open-label AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
275336|NCT01314716|E3|Reported Event|AZLI-AZLI (Open-Label)|Adverse events for this reporting group were reported from Day 112 to Day 196 plus 30 days while participants were receiving open-label AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
275337|NCT01314716|E2|Reported Event|Placebo-AZLI (Double-Blind)|Adverse events for this reporting group were reported from baseline to Day 112 while participants were receiving double-blind placebo; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
275338|NCT01314716|E1|Reported Event|AZLI-AZLI (Double-Blind)|Adverse events for this reporting group were reported from baseline to Day 112 while participants were receiving double-blind AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
275339|NCT01314703|B1|Baseline|Group 1|All subjects received treatment with both the test article and the positive control
275340|NCT01314703|P1|Participant Flow|ChloraPrep and 70% Isopropyl Alcohol|All subjects received treatment with both the ChloraPrep and 70% Isopropyl Alcohol
275341|NCT01314703|O2|Outcome|70% Isopropyl Alcohol, 10.5 mL Applicator|All subjects received single application of treatment with 70% Isopropyl Alcohol 10.5 mL Applicator on two treatment sites (abdomen and groin).
275342|NCT01314703|O1|Outcome|ChloraPrep One Step, 10.5 mL Applicator|All subjects received single application of treatment with ChloraPrep One Step 10.5 mL Applicator on two treatment sites (abdomen and groin).
275343|NCT01314703|E1|Reported Event|Group 1|All subjects received treatment with both the test article and the positive control
275344|NCT01314443|B5|Baseline|Total|Total of all reporting groups
275345|NCT01314443|B4|Baseline|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of NRT
275346|NCT01314443|B3|Baseline|Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of NRT
275347|NCT01314443|B2|Baseline|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
275348|NCT01314443|B1|Baseline|Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
275349|NCT01314443|P4|Participant Flow|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
275350|NCT01314443|P3|Participant Flow|Dietary Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
275351|NCT01314443|P2|Participant Flow|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
275352|NCT01314443|P1|Participant Flow|Dietary Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
275353|NCT01314443|O4|Outcome|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
275354|NCT01314443|O3|Outcome|Dietary Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
275355|NCT01314443|O2|Outcome|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
275356|NCT01314443|O1|Outcome|Dietary Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
275358|NCT01314443|O3|Outcome|Dietary Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
275359|NCT01314443|O2|Outcome|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
275360|NCT01314443|O1|Outcome|Dietary Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
275361|NCT01314443|O4|Outcome|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
275362|NCT01314443|O3|Outcome|Dietary Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
275363|NCT01314443|O2|Outcome|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
275364|NCT01314443|O1|Outcome|Dietary Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
275365|NCT01314443|E4|Reported Event|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
275366|NCT01314443|E3|Reported Event|Dietary Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
275367|NCT01314443|E2|Reported Event|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
275368|NCT01314443|E1|Reported Event|Dietary Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
275369|NCT01314417|B1|Baseline|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275370|NCT01314417|P1|Participant Flow|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275371|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275372|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275373|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275374|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275375|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275376|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275377|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275378|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275379|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275380|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275381|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275382|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275383|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275384|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275385|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275386|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275387|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275388|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275389|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275390|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275391|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275392|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275393|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275394|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275395|NCT01314417|E1|Reported Event|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
275396|NCT01314261|B5|Baseline|Total|Total of all reporting groups
275397|NCT01314261|B4|Baseline|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275398|NCT01314261|B3|Baseline|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275399|NCT01314261|B2|Baseline|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275400|NCT01314261|B1|Baseline|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275401|NCT01314261|P4|Participant Flow|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275402|NCT01314261|P3|Participant Flow|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275403|NCT01314261|P2|Participant Flow|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275404|NCT01314261|P1|Participant Flow|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275405|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275406|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275407|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275408|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275409|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275410|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275411|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275412|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275413|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275414|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275415|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275416|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275417|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275418|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275419|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275420|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275421|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275422|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275423|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275424|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275425|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275426|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275427|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275428|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275429|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275430|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275431|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275432|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275433|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275434|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275435|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275436|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275437|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275438|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275439|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275440|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275441|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275442|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275443|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275444|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275445|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275446|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275447|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275448|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275449|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275450|NCT01314261|E4|Reported Event|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275451|NCT01314261|E3|Reported Event|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275452|NCT01314261|E2|Reported Event|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 10 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275453|NCT01314261|E1|Reported Event|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
275454|NCT01314118|B1|Baseline|Abiraterone Acetate|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
275455|NCT01314118|P1|Participant Flow|Abiraterone Acetate|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
275456|NCT01314118|O1|Outcome|Abiraterone Acetate and Prednisone|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
275457|NCT01314118|O1|Outcome|Abiraterone Acetate and Prednisone|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
275458|NCT01314118|O1|Outcome|Abiraterone Acetate and Prednisone|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
275459|NCT01314118|O1|Outcome|Abiraterone Acetate and Prednisone|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
275460|NCT01314118|E1|Reported Event|Abiraterone Acetate|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
275461|NCT01314105|B3|Baseline|Total|Total of all reporting groups
275462|NCT01314105|B2|Baseline|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275463|NCT01314105|B1|Baseline|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275464|NCT01314105|P2|Participant Flow|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275465|NCT01314105|P1|Participant Flow|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275466|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275467|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275468|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275469|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275470|NCT01314105|O2|Outcome|All Patients|Nintedanib (200 mg or 150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275471|NCT01314105|O1|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275472|NCT01314105|O2|Outcome|All Patients|Nintedanib (200 mg or 150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275473|NCT01314105|O1|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275632|NCT01313780|O1|Outcome|Oxycodone and Naloxone|Trade name is TARGIN. Daily dose can be titrated up to 40mg B.I.D.
275474|NCT01314105|O2|Outcome|All Patients|Nintedanib (200 mg or 150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275475|NCT01314105|O1|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275476|NCT01314105|O2|Outcome|All Patients|Nintedanib (200 mg or 150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275477|NCT01314105|O1|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275478|NCT01314105|O2|Outcome|All Patients|Nintedanib (200 mg or 150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275479|NCT01314105|O1|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275480|NCT01314105|O2|Outcome|All Patients|Nintedanib (200 mg or 150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275481|NCT01314105|O1|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275482|NCT01314105|O2|Outcome|All Patients|Nintedanib (200 mg or 150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275483|NCT01314105|O1|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275484|NCT01314105|O2|Outcome|All Patients|Nintedanib (200 mg or 150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275485|NCT01314105|O1|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275486|NCT01314105|O2|Outcome|All Patients|Nintedanib (200 mg or 150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275487|NCT01314105|O1|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275488|NCT01314105|O2|Outcome|All Patients|Nintedanib (200 mg or 150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275489|NCT01314105|O1|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275490|NCT01314105|O2|Outcome|All Patients|Nintedanib (200 mg or 150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275491|NCT01314105|O1|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275492|NCT01314105|O2|Outcome|All Patients|Nintedanib (200 mg or 150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275493|NCT01314105|O1|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275494|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275495|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275496|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275516|NCT01314001|B2|Baseline|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
275497|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275498|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275499|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275500|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275501|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275502|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275503|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275504|NCT01314105|E2|Reported Event|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275505|NCT01314105|E1|Reported Event|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
275506|NCT01314014|B1|Baseline|Imexon|"Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.~Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment."
275507|NCT01314014|P1|Participant Flow|Imexon|"Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.~Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment."
275508|NCT01314014|O1|Outcome|Imexon|"Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.~Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment."
275509|NCT01314014|O1|Outcome|Imexon|"Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.~Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment."
275510|NCT01314014|E1|Reported Event|Imexon|"Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.~Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment."
275511|NCT01314001|B7|Baseline|Total|Total of all reporting groups
275512|NCT01314001|B6|Baseline|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
275513|NCT01314001|B5|Baseline|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
275514|NCT01314001|B4|Baseline|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
275515|NCT01314001|B3|Baseline|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
275633|NCT01313780|E2|Reported Event|Oxycodone|oxycodone : Trade name is Oxycontin
275517|NCT01314001|B1|Baseline|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
275518|NCT01314001|P6|Participant Flow|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
275519|NCT01314001|P5|Participant Flow|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
275520|NCT01314001|P4|Participant Flow|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
275521|NCT01314001|P3|Participant Flow|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
275522|NCT01314001|P2|Participant Flow|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
275523|NCT01314001|P1|Participant Flow|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
275524|NCT01314001|O6|Outcome|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
275525|NCT01314001|O5|Outcome|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
275526|NCT01314001|O4|Outcome|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
275527|NCT01314001|O3|Outcome|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
275528|NCT01314001|O2|Outcome|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
275529|NCT01314001|O1|Outcome|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
275530|NCT01314001|O6|Outcome|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
275531|NCT01314001|O5|Outcome|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
275532|NCT01314001|O4|Outcome|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
275533|NCT01314001|O3|Outcome|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
275534|NCT01314001|O2|Outcome|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
275535|NCT01314001|O1|Outcome|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
275536|NCT01314001|O6|Outcome|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
275537|NCT01314001|O5|Outcome|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
275538|NCT01314001|O4|Outcome|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
275539|NCT01314001|O3|Outcome|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
275540|NCT01314001|O2|Outcome|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
275541|NCT01314001|O1|Outcome|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
275542|NCT01314001|O6|Outcome|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
275634|NCT01313780|E1|Reported Event|Oxycodone and Naloxone|Oxycodone and naloxone: Trade name is TARGIN.
275543|NCT01314001|O5|Outcome|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
275544|NCT01314001|O4|Outcome|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
275545|NCT01314001|O3|Outcome|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
275546|NCT01314001|O2|Outcome|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
275547|NCT01314001|O1|Outcome|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
275548|NCT01314001|O6|Outcome|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
275549|NCT01314001|O5|Outcome|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
275550|NCT01314001|O4|Outcome|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
275551|NCT01314001|O3|Outcome|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
275552|NCT01314001|O2|Outcome|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
275553|NCT01314001|O1|Outcome|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
275554|NCT01314001|O6|Outcome|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
275555|NCT01314001|O5|Outcome|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
275556|NCT01314001|O4|Outcome|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
275557|NCT01314001|O3|Outcome|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
275558|NCT01314001|O2|Outcome|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
275559|NCT01314001|O1|Outcome|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
275560|NCT01314001|E6|Reported Event|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
275561|NCT01314001|E5|Reported Event|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
275562|NCT01314001|E4|Reported Event|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
275563|NCT01314001|E3|Reported Event|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
275564|NCT01314001|E2|Reported Event|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
275565|NCT01314001|E1|Reported Event|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
275566|NCT01313936|B3|Baseline|Total|Total of all reporting groups
275567|NCT01313936|B2|Baseline|18 mCi/kg of 131I-MIBG|"The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
275568|NCT01313936|B1|Baseline|15 mCi/kg of 131I-MIBG|"The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
275569|NCT01313936|P2|Participant Flow|18 mCi/kg of 131I-MIBG|"The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
275570|NCT01313936|P1|Participant Flow|15 mCi/kg of 131I-MIBG|"The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
275571|NCT01313936|O2|Outcome|18 mCi/kg of 131I-MIBG|"The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
275572|NCT01313936|O1|Outcome|15 mCi/kg of 131I-MIBG|"The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
275573|NCT01313936|O2|Outcome|18 mCi/kg of 131I-MIBG|"The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
275574|NCT01313936|O1|Outcome|15 mCi/kg of 131I-MIBG|"The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
275575|NCT01313936|E2|Reported Event|18 mCi/kg of 131I-MIBG|"The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
275576|NCT01313936|E1|Reported Event|15 mCi/kg of 131I-MIBG|"The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
275577|NCT01313923|B1|Baseline|Sirolimus|All patient will be open-label; Sirolimus. Dosage is variable based on FDA guidelines.
275578|NCT01313923|P1|Participant Flow|Sirolimus|There is one arm to the study. All patients will be open-label, Sirolimus. There is no set dosage: medication dose will be based on FDA approved guidelines.
275579|NCT01313923|O1|Outcome|Sirolimus (Formerly Known as Rapamycin)|No results. Study has been terminated by investigator.
275580|NCT01313923|E1|Reported Event|Sirolimus (Formerly Known as Rapamycin)|No results as study has been terminated early by the investigator.
275581|NCT01313910|B1|Baseline|ImmunoLin®|8-week treatment course
275582|NCT01313910|P1|Participant Flow|ImmunoLin®|2.5 grams twice daily for eight weeks
275583|NCT01313910|O1|Outcome|ImmunoLin®|8-week treatment course
275584|NCT01313910|O1|Outcome|ImmunoLin®|8-week treatment course
275585|NCT01313910|O1|Outcome|ImmunoLin®|8-week treatment course
275586|NCT01313910|O1|Outcome|ImmunoLin®|8-week treatment course
275587|NCT01313910|O1|Outcome|ImmunoLin®|8-week treatment course
275588|NCT01313910|E1|Reported Event|ImmunoLin®|8-week treatment course
275589|NCT01313897|B1|Baseline|Study Treatment|Bortezomib (1.0 mg/m2, IV) Days -9,-6,-2 (3 doses) Mesna (30 mg/kg, IV) Days -7, -6 (2 doses) Cyclophasphamide (60 mg/kg, IV) Day -7 (1 dose) Dexamethasone (40 mg, PO) Days -6 to -3 (4 doses) Expanded Natural Killer (exp-NK) Cell Infusion Day 0 (1 dose) Aldesleukin (IL-2) (3x10^6 IU, SC) Days 0 to 12 (13 doses)
275590|NCT01313897|P1|Participant Flow|Study Treatment|Bortezomib (1.0 mg/m2, IV) Days -9,-6,-2 (3 doses) Mesna (30 mg/kg, IV) Days -7, -6 (2 doses) Cyclophasphamide (60 mg/kg, IV) Day -7 (1 dose) Dexamethasone (40 mg, PO) Days -6 to -3 (4 doses) Expanded Natural Killer (exp-NK) Cell Infusion Day 0 (1 dose) Aldesleukin (IL-2) (3x10^6 IU, SC) Days 0 to 12 (13 doses)
275591|NCT01313897|O1|Outcome|Velcade for Anti-MM Therapy|"Day(s) -9,-6,-2 3 doses of Bortezomib at 1.0 mg/m2, i.v.~Bortezomib: bortezomib given days -9, -6, and -2 at 1.0mg/m2, i.v."
275592|NCT01313897|E1|Reported Event|Study Treatment|Bortezomib (1.0 mg/m2, IV) Days -9,-6,-2 (3 doses) Mesna (30 mg/kg, IV) Days -7, -6 (2 doses) Cyclophasphamide (60 mg/kg, IV) Day -7 (1 dose) Dexamethasone (40 mg, PO) Days -6 to -3 (4 doses) Expanded Natural Killer (exp-NK) Cell Infusion Day 0 (1 dose) Aldesleukin (IL-2) (3x10^6 IU, SC) Days 0 to 12 (13 doses)
275593|NCT01313884|B1|Baseline|Combination Therapy|"Regimen A alternate with Regimen B every 21 days~Regimen A:~Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)~Regimen B:~Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.~Irinotecan: 50 mg/m2/day x 5 days~Vincristine: 2 mg/m2 (capped at 2mg total do)~Temozolomide: 100 mg/m2/day x 5 days~Doxorubicin: 75 mg/m2~Cytoxan: 1200 mg/m2~Pegfilgrastim: 6 mg~Mesna: 240 mg/m2 in 50 ml NS"
275594|NCT01313884|P1|Participant Flow|Combination Therapy|"Regimen A alternate with Regimen B every 21 days~Regimen A:~Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)~Regimen B:~Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.~Irinotecan: 50 mg/m2/day x 5 days~Vincristine: 2 mg/m2 (capped at 2mg total do)~Temozolomide: 100 mg/m2/day x 5 days~Doxorubicin: 75 mg/m2~Cytoxan: 1200 mg/m2~Pegfilgrastim: 6 mg~Mesna: 240 mg/m2 in 50 ml NS"
275628|NCT01313780|P1|Participant Flow|Oxycodone and Naloxone|Trade name is TARGIN. Daily dose can be titrated up to 40mg B.I.D.
275595|NCT01313884|O1|Outcome|Combination Therapy|"Regimen A alternating with Regimen B every 21 days~Regimen A:~Cytoxan 1200mg/m2~Doxorubicin, starting dose 75 mg/m2 to a maximum of 450mg/m2~Vincristine, starting dose 2 mg/m2 to a maximum of 2 mg~Pegfilgrastim, 6 mg subcutaneous within 24 to 48 hours after each cycle~Regimen B:~Irinotecan 50 mg/m2/day x 5 days~Temozolomide 100 mg/m2/day x 5 days followed by 2 weeks treatment-free"
275596|NCT01313884|O1|Outcome|Combination Therapy|"Regimen A alternating with Regimen B every 21 days~Regimen A:~Cytoxan 1200mg/m2~Doxorubicin, starting dose 75 mg/m2 to a maximum of 450mg/m2~Vincristine, starting dose 2 mg/m2 to a maximum of 2 mg~Pegfilgrastim, 6 mg subcutaneous within 24 to 48 hours after each cycle~Regimen B:~Irinotecan 50 mg/m2/day x 5 days~Temozolomide 100 mg/m2/day x 5 days followed by 2 weeks treatment-free"
275597|NCT01313884|E1|Reported Event|Combination Therapy|"Regimen A alternate with Regimen B every 21 days~Regimen A:~Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)~Regimen B:~Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.~Irinotecan: 50 mg/m2/day x 5 days~Vincristine: 2 mg/m2 (capped at 2mg total do)~Temozolomide: 100 mg/m2/day x 5 days~Doxorubicin: 75 mg/m2~Cytoxan: 1200 mg/m2~Pegfilgrastim: 6 mg~Mesna: 240 mg/m2 in 50 ml NS"
275598|NCT01313858|B4|Baseline|Total|Total of all reporting groups
275599|NCT01313858|B3|Baseline|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
275600|NCT01313858|B2|Baseline|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
275601|NCT01313858|B1|Baseline|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
275602|NCT01313858|P3|Participant Flow|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
275603|NCT01313858|P2|Participant Flow|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
275604|NCT01313858|P1|Participant Flow|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
275605|NCT01313858|O3|Outcome|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
275606|NCT01313858|O2|Outcome|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
275607|NCT01313858|O1|Outcome|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
275608|NCT01313858|O3|Outcome|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
275609|NCT01313858|O2|Outcome|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
275610|NCT01313858|O1|Outcome|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
275611|NCT01313858|O3|Outcome|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
275612|NCT01313858|O2|Outcome|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
275613|NCT01313858|O1|Outcome|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
275614|NCT01313858|O3|Outcome|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
275615|NCT01313858|O2|Outcome|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
275616|NCT01313858|O1|Outcome|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
275617|NCT01313858|O3|Outcome|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
275618|NCT01313858|O2|Outcome|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
275619|NCT01313858|O1|Outcome|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
275620|NCT01313858|O3|Outcome|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
275621|NCT01313858|O2|Outcome|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
275622|NCT01313858|O1|Outcome|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
275623|NCT01313858|E1|Reported Event|All Participants|Simponi®-naïve participants with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
275624|NCT01313780|B3|Baseline|Total|Total of all reporting groups
275625|NCT01313780|B2|Baseline|Oxycodone|Trade name is Oxycontin. Daily dose can be titrated up to 40mg B.I.D.
275626|NCT01313780|B1|Baseline|Oxycodone and Naloxone|Trade name is TARGIN. Daily dose can be titrated up to 40mg B.I.D.
275627|NCT01313780|P2|Participant Flow|Oxycodone|Trade name is Oxycontin. Daily dose can be titrated up to 40mg B.I.D.
275635|NCT01313728|B1|Baseline|Overall Study|This was a single-group study with two treatment arms using a split-face model, i.e., all subjects received both interventions on opposite sides of the face.
275636|NCT01313728|P1|Participant Flow|Overall Study|This was a single-group study with two treatment arms using a split-face model, i.e., all subjects received both interventions on opposite sides of the face.
275637|NCT01313728|O2|Outcome|Tretinoin Gel Alone|Tretinoin gel applied once daily to the assigned side of the face
275638|NCT01313728|O1|Outcome|Dapsone Gel + Tretinoin Gel|Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
275639|NCT01313728|O2|Outcome|Tretinoin Gel Alone|Tretinoin gel applied once daily to the assigned side of the face
275640|NCT01313728|O1|Outcome|Dapsone Gel + Tretinoin Gel|Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
275641|NCT01313728|O2|Outcome|Tretinoin Gel Alone|Tretinoin gel applied once daily to the assigned side of the face
275642|NCT01313728|O1|Outcome|Dapsone Gel + Tretinoin Gel|Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
275643|NCT01313728|O2|Outcome|Tretinoin Gel Alone|Tretinoin gel applied once daily to the assigned side of the face
275644|NCT01313728|O1|Outcome|Dapsone Gel + Tretinoin Gel|Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
275645|NCT01313728|O2|Outcome|Tretinoin Gel Alone|Tretinoin gel applied once daily to the assigned side of the face
275646|NCT01313728|O1|Outcome|Dapsone Gel + Tretinoin Gel|Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
275647|NCT01313728|O2|Outcome|Tretinoin Gel Alone|Tretinoin gel applied once daily to the assigned side of the face
275648|NCT01313728|O1|Outcome|Dapsone Gel + Tretinoin Gel|Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
275649|NCT01313728|E1|Reported Event|Overall Study|This was a single-group study with two treatment arms using a split-face model, i.e., all subjects received both interventions on opposite sides of the face.
275650|NCT01313689|B3|Baseline|Total|Total of all reporting groups
275651|NCT01313689|B2|Baseline|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
275652|NCT01313689|B1|Baseline|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275653|NCT01313689|P4|Participant Flow|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275654|NCT01313689|P3|Participant Flow|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275671|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275655|NCT01313689|P2|Participant Flow|Physician's Choice|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
275656|NCT01313689|P1|Participant Flow|Ofatumumab|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275657|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275658|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275659|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
275660|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275661|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275662|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275724|NCT01313676|P3|Participant Flow|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
275787|NCT01313650|P2|Participant Flow|UMEC 62.5 µg QD|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) QD via a DPI in the morning for 24 weeks.
275663|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
275664|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275665|NCT01313689|O3|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275666|NCT01313689|O2|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275667|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275668|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275669|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275670|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
275725|NCT01313676|P2|Participant Flow|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
275793|NCT01313650|O4|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
275672|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275673|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275674|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
275675|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275676|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275677|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275678|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
275679|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275726|NCT01313676|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
275788|NCT01313650|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
275680|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
275681|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275682|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275683|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275684|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
275685|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275686|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275687|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275727|NCT01313676|O4|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
275789|NCT01313650|O4|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
275688|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
275689|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275690|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275691|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275692|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
275693|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275694|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275695|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275728|NCT01313676|O3|Outcome|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
275790|NCT01313650|O3|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
275696|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
275697|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275698|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275699|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275700|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
275701|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275702|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275703|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275729|NCT01313676|O2|Outcome|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
275791|NCT01313650|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
275704|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
275705|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275706|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275707|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275708|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
275709|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275710|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275711|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275730|NCT01313676|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period
275792|NCT01313650|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
275712|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
275713|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275714|NCT01313689|E4|Reported Event|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275715|NCT01313689|E3|Reported Event|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275716|NCT01313689|E2|Reported Event|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
275717|NCT01313689|E1|Reported Event|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
275718|NCT01313676|B5|Baseline|Total|Total of all reporting groups
275719|NCT01313676|B4|Baseline|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
275720|NCT01313676|B3|Baseline|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
275721|NCT01313676|B2|Baseline|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
275722|NCT01313676|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
275723|NCT01313676|P4|Participant Flow|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
275782|NCT01313650|B3|Baseline|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
275783|NCT01313650|B2|Baseline|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
275731|NCT01313676|O4|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
275732|NCT01313676|O3|Outcome|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
275733|NCT01313676|O2|Outcome|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
275734|NCT01313676|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
275735|NCT01313676|O4|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
275736|NCT01313676|O3|Outcome|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
275737|NCT01313676|O2|Outcome|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
275738|NCT01313676|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
275739|NCT01313676|E4|Reported Event|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
275740|NCT01313676|E3|Reported Event|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
275741|NCT01313676|E2|Reported Event|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
275742|NCT01313676|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
275743|NCT01313663|B3|Baseline|Total|Total of all reporting groups
275744|NCT01313663|B2|Baseline|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275745|NCT01313663|B1|Baseline|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275746|NCT01313663|P2|Participant Flow|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275747|NCT01313663|P1|Participant Flow|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275748|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275749|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275784|NCT01313650|B1|Baseline|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
275785|NCT01313650|P4|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
275750|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275751|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275752|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275753|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275754|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275755|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275756|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275757|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275758|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275759|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275760|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275761|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275762|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275763|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275764|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275786|NCT01313650|P3|Participant Flow|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 24 weeks.
309237|NCT01222520|E1|Reported Event|Telmisartan and Amlodipine FDC|
275765|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275766|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275767|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275768|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275769|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275770|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275771|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275772|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275773|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275774|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275775|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275776|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275777|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275778|NCT01313663|E2|Reported Event|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275779|NCT01313663|E1|Reported Event|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
275780|NCT01313650|B5|Baseline|Total|Total of all reporting groups
275781|NCT01313650|B4|Baseline|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
275795|NCT01313650|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
275796|NCT01313650|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
275797|NCT01313650|O4|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
275798|NCT01313650|O3|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
275799|NCT01313650|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
275800|NCT01313650|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
275801|NCT01313650|O4|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
275802|NCT01313650|O3|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
275803|NCT01313650|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
275804|NCT01313650|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
275805|NCT01313650|E4|Reported Event|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
275806|NCT01313650|E3|Reported Event|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
275807|NCT01313650|E2|Reported Event|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
275808|NCT01313650|E1|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
275809|NCT01313637|B5|Baseline|Total|Total of all reporting groups
275810|NCT01313637|B4|Baseline|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
275811|NCT01313637|B3|Baseline|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
275812|NCT01313637|B2|Baseline|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
275813|NCT01313637|B1|Baseline|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
275814|NCT01313637|P4|Participant Flow|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
275815|NCT01313637|P3|Participant Flow|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 24 weeks.
275816|NCT01313637|P2|Participant Flow|UMEC 125 µg QD|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD via a DPI in the morning for 24 weeks.
275817|NCT01313637|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
275818|NCT01313637|O4|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
275819|NCT01313637|O3|Outcome|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
275820|NCT01313637|O2|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
275821|NCT01313637|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
275822|NCT01313637|O4|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
275823|NCT01313637|O3|Outcome|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
275824|NCT01313637|O2|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
275825|NCT01313637|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
275826|NCT01313637|O4|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
275827|NCT01313637|O3|Outcome|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
275828|NCT01313637|O2|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
275829|NCT01313637|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
275830|NCT01313637|O4|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
275831|NCT01313637|O3|Outcome|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
275832|NCT01313637|O2|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
275833|NCT01313637|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
275834|NCT01313637|E4|Reported Event|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
275835|NCT01313637|E3|Reported Event|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
275836|NCT01313637|E2|Reported Event|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
275837|NCT01313637|E1|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
275838|NCT01313624|B3|Baseline|Total|Total of all reporting groups
275839|NCT01313624|B2|Baseline|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
275840|NCT01313624|B1|Baseline|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
275841|NCT01313624|P2|Participant Flow|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
275867|NCT01313559|E1|Reported Event|Cohort A (Pasireotide)|"Patients receive pasireotide IM once every 4 weeks~Pasireotide: Given IM~Laboratory biomarker analysis: Correlative studies"
275868|NCT01313520|B3|Baseline|Total|Total of all reporting groups
275869|NCT01313520|B2|Baseline|Placebo|saline via intravenous infusion
275842|NCT01313624|P1|Participant Flow|AZLI-AZLI|Participants were randomized to receive blinded Aztreonam for Inhalation Solution (AZLI) 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
275843|NCT01313624|O2|Outcome|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
275844|NCT01313624|O1|Outcome|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
275845|NCT01313624|O2|Outcome|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
275846|NCT01313624|O1|Outcome|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
275847|NCT01313624|O2|Outcome|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
275848|NCT01313624|O1|Outcome|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
275849|NCT01313624|E4|Reported Event|Placebo-AZLI (Open-Label)|Adverse events for this reporting group were reported from Day 112 to Day 196 plus 30 days while participants were receiving open-label AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
275850|NCT01313624|E3|Reported Event|AZLI-AZLI (Open-Label)|Adverse events for this reporting group were reported from Day 112 to Day 196 plus 30 days while participants were receiving open-label AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
275851|NCT01313624|E2|Reported Event|Placebo-AZLI (Double-Blind)|Adverse events for this reporting group were reported from baseline to Day 112 while participants were receiving double-blind placebo; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
275852|NCT01313624|E1|Reported Event|AZLI-AZLI (Double-Blind)|Adverse events for this reporting group were reported from baseline to Day 112 while participants were receiving double-blind AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
275853|NCT01313559|B3|Baseline|Total|Total of all reporting groups
275854|NCT01313559|B2|Baseline|Cohort B (Pasireotide and Everolimus)|"Patients receive pasireotide as in cohort A and everolimus PO QD~Pasireotide: Given IM~Everolimus: Given PO~Laboratory biomarker analysis: Correlative studies"
275855|NCT01313559|B1|Baseline|Cohort A (Pasireotide)|"Patients receive pasireotide IM once every 4 weeks~Pasireotide: Given IM~Laboratory biomarker analysis: Correlative studies"
275856|NCT01313559|P2|Participant Flow|Cohort B (Pasireotide and Everolimus)|"Patients receive pasireotide as in cohort A and everolimus PO QD~Pasireotide: Given IM~Everolimus: Given PO~Laboratory biomarker analysis: Correlative studies"
275857|NCT01313559|P1|Participant Flow|Cohort A (Pasireotide)|"Patients receive pasireotide IM once every 4 weeks~Pasireotide: Given IM~Laboratory biomarker analysis: Correlative studies"
275858|NCT01313559|O2|Outcome|Cohort B (Pasireotide and Everolimus)|"Patients receive pasireotide as in cohort A and everolimus PO QD~Pasireotide: Given IM~Everolimus: Given PO~Laboratory biomarker analysis: Correlative studies"
275859|NCT01313559|O1|Outcome|Cohort A (Pasireotide)|"Patients receive pasireotide IM once every 4 weeks~Pasireotide: Given IM~Laboratory biomarker analysis: Correlative studies"
275860|NCT01313559|O2|Outcome|Cohort B (Pasireotide and Everolimus)|"Patients receive pasireotide as in cohort A and everolimus PO QD~Pasireotide: Given IM~Everolimus: Given PO~Laboratory biomarker analysis: Correlative studies"
275861|NCT01313559|O1|Outcome|Cohort A (Pasireotide)|"Patients receive pasireotide IM once every 4 weeks~Pasireotide: Given IM~Laboratory biomarker analysis: Correlative studies"
275862|NCT01313559|O2|Outcome|Cohort B (Pasireotide and Everolimus)|"Patients receive pasireotide as in cohort A and everolimus PO QD~Pasireotide: Given IM~Everolimus: Given PO~Laboratory biomarker analysis: Correlative studies"
275863|NCT01313559|O1|Outcome|Cohort A (Pasireotide)|"Patients receive pasireotide IM once every 4 weeks~Pasireotide: Given IM~Laboratory biomarker analysis: Correlative studies"
275864|NCT01313559|O2|Outcome|Cohort B (Pasireotide and Everolimus)|"Patients receive pasireotide as in cohort A and everolimus PO QD~Pasireotide: Given IM~Everolimus: Given PO~Laboratory biomarker analysis: Correlative studies"
275865|NCT01313559|O1|Outcome|Cohort A (Pasireotide)|"Patients receive pasireotide IM once every 4 weeks~Pasireotide: Given IM~Laboratory biomarker analysis: Correlative studies"
275866|NCT01313559|E2|Reported Event|Cohort B (Pasireotide and Everolimus)|"Patients receive pasireotide as in cohort A and everolimus PO QD~Pasireotide: Given IM~Everolimus: Given PO~Laboratory biomarker analysis: Correlative studies"
314116|NCT01211145|O1|Outcome|Placebo|Placebo to ZOMIG nasal spray
275871|NCT01313520|P2|Participant Flow|Placebo|saline via intravenous infusion
275872|NCT01313520|P1|Participant Flow|Infliximab|3 mg/kg of Infliximab intravenous infusion
275873|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
275874|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab intravenous infusion
275875|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
275876|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab intravenous infusion
275877|NCT01313520|O2|Outcome|Placebo|Saline via intravenous infusion
275878|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab via intravenous infusion
275879|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
275880|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab via intravenous infusion
275881|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
275882|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab via intravenous infusion
275883|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
275884|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab intravenous infusion
275885|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
275886|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab intravenous infusion
275887|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
275888|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab intravenous infusion
275889|NCT01313520|E2|Reported Event|Placebo|saline via intravenous infusion
275890|NCT01313520|E1|Reported Event|Infliximab|3 mg/kg of Infliximab intravenous infusion
275891|NCT01313507|B1|Baseline|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 or 4 weeks for 3 months (5 or 4 total infusions, respectively).
275892|NCT01313507|P1|Participant Flow|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 or 4 weeks for 3 months (5 or 4 total infusions, respectively).
275893|NCT01313507|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 or 4 weeks for 3 months (5 or 4 total infusions, respectively).
275894|NCT01313507|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 or 4 weeks for 3 months (5 or 4 total infusions, respectively).
275895|NCT01313507|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 or 4 weeks for 3 months (5 or 4 total infusions, respectively).
275896|NCT01313507|E1|Reported Event|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 or 4 weeks for 3 months (5 or 4 total infusions, respectively).
275897|NCT01313494|B3|Baseline|Total|Total of all reporting groups
275898|NCT01313494|B2|Baseline|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275899|NCT01313494|B1|Baseline|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275900|NCT01313494|P2|Participant Flow|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275901|NCT01313494|P1|Participant Flow|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275902|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275903|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275904|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275905|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275906|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275907|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275908|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275909|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275910|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275911|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275912|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275913|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275914|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275915|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275916|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275917|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275918|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275919|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275920|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275921|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275922|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275923|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275924|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275925|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275926|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275927|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275928|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275929|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275930|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275931|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275932|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275933|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275934|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275935|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275936|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275937|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275938|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275939|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275940|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275941|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275942|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275943|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275944|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275945|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275946|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275947|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275948|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275949|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275950|NCT01313494|E2|Reported Event|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
275951|NCT01313494|E1|Reported Event|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
275952|NCT01313312|B1|Baseline|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275953|NCT01313312|P1|Participant Flow|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 intramuscular (i.m.) injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275954|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275955|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275956|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
276473|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
275957|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275958|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275959|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275960|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275961|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275962|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275963|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
276018|NCT01313273|P2|Participant Flow|Arm B: Lanreotide + Non Steroidal Anti Androgens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non steroidal anti androgens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
276019|NCT01313273|P1|Participant Flow|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal anti androgens (e.g. bicalutamide 50 mg/day) plus Luteinizing Hormone-Releasing Hormone Analogues (LHRH-a) (e.g. triptorelin 3.75 mg/month) till progression.
276474|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
275964|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275965|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275966|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275967|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275968|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275969|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275970|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
276020|NCT01313273|O2|Outcome|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
276021|NCT01313273|O1|Outcome|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
276128|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
275971|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275972|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275973|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275974|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275975|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275976|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275977|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
276022|NCT01313273|O2|Outcome|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
276023|NCT01313273|O1|Outcome|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
276164|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
275978|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275979|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275980|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275981|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275982|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275983|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275984|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
276024|NCT01313273|O2|Outcome|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
276025|NCT01313273|O1|Outcome|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
276304|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
275985|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275986|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275987|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275988|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275989|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275990|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275991|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
276026|NCT01313273|O2|Outcome|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
276027|NCT01313273|O1|Outcome|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
276305|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
275992|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275993|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275994|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275995|NCT01313312|E1|Reported Event|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
275996|NCT01313299|B4|Baseline|Total|Total of all reporting groups
275997|NCT01313299|B3|Baseline|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
275998|NCT01313299|B2|Baseline|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
275999|NCT01313299|B1|Baseline|Placebo|Placebo intramuscular injection single treatment cycle on day 1
276000|NCT01313299|P3|Participant Flow|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
276001|NCT01313299|P2|Participant Flow|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
276002|NCT01313299|P1|Participant Flow|Placebo|Placebo intramuscular injection single treatment cycle on day 1
276003|NCT01313299|O3|Outcome|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
276004|NCT01313299|O2|Outcome|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
276005|NCT01313299|O1|Outcome|Placebo|Placebo intramuscular injection single treatment cycle on day 1
276006|NCT01313299|O3|Outcome|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
276007|NCT01313299|O2|Outcome|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
276008|NCT01313299|O1|Outcome|Placebo|Placebo intramuscular injection single treatment cycle on day 1
276009|NCT01313299|O3|Outcome|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
276010|NCT01313299|O2|Outcome|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
276011|NCT01313299|O1|Outcome|Placebo|Placebo intramuscular injection single treatment cycle on day 1
276012|NCT01313299|E3|Reported Event|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
276013|NCT01313299|E2|Reported Event|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
276014|NCT01313299|E1|Reported Event|Placebo|Placebo intramuscular injection single treatment cycle on day 1
276015|NCT01313273|B3|Baseline|Total|Total of all reporting groups
276016|NCT01313273|B2|Baseline|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
276017|NCT01313273|B1|Baseline|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
276060|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
276028|NCT01313273|E2|Reported Event|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
276029|NCT01313273|E1|Reported Event|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
276030|NCT01313221|B4|Baseline|Total|Total of all reporting groups
276031|NCT01313221|B3|Baseline|Non-randomized|Enrolled participants received etanercept 50 mg twice weekly but discontinued prior to completing the 12-week open-label treatment period.
276032|NCT01313221|B2|Baseline|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
276033|NCT01313221|B1|Baseline|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
276034|NCT01313221|P3|Participant Flow|Non-randomized|Enrolled participants received etanercept 50 mg twice weekly but discontinued prior to completing the 12-week open-label treatment period.
276035|NCT01313221|P2|Participant Flow|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
276036|NCT01313221|P1|Participant Flow|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
276037|NCT01313221|O2|Outcome|Etanercept + Topical|All participants who used a topical agent at least once during the study, regardless of treatment group assignment.
276038|NCT01313221|O1|Outcome|Etanercept Monotherapy|All participants who received etanercept at any time during the study, who never used a topical agent, regardless of treatment assignment, including those participants who were not randomized at Week 12.
276039|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
276040|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
276041|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
276042|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
276043|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
276044|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
276045|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
276046|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
276047|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
276048|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
276049|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
276050|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
276051|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
276052|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
276053|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
276054|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
276055|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
276056|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
276057|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
276058|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
276059|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
276092|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276061|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
276062|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
276063|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
276064|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
276065|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
276066|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
276067|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
276068|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
276069|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
276070|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
276071|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
276072|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
276073|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
276074|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
276075|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
276076|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
276077|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
276078|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
276079|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
276080|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
276081|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
276082|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
276083|NCT01313221|E2|Reported Event|Etanercept + Topical|All participants who used a topical agent at least once during the study, regardless of treatment group assignment.
276084|NCT01313221|E1|Reported Event|Etanercept Monotherapy|All participants who received etanercept at any time during the study, who never used a topical agent, regardless of treatment assignment, including those participants who were not randomized at Week 12.
276085|NCT01313208|B3|Baseline|Total|Total of all reporting groups
276086|NCT01313208|B2|Baseline|Etanercept|"Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks.~All participants continued their DMARD treatment throughout the 24-week study period."
276087|NCT01313208|B1|Baseline|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.
276088|NCT01313208|P2|Participant Flow|Etanercept|"Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks.~All participants continued their DMARD treatment throughout the 24-week study period."
276089|NCT01313208|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.
276090|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276091|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276670|NCT01311102|O2|Outcome|Normal Saline|Normal Saline : 1.33cc of normal saline
276093|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276094|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276095|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276096|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276097|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276098|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276099|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276100|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276101|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276102|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276103|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276104|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276105|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276106|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276107|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276108|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276109|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276110|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276111|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276112|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276113|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276114|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276115|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276116|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276117|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276118|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276119|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276120|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276121|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276122|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276123|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276124|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276125|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276126|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276127|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276306|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
276129|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276130|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276131|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276132|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276133|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276134|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276135|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276136|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276137|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276138|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276139|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276140|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276141|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276142|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276143|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276144|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276145|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276146|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276147|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276148|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276149|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276150|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276151|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276152|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276153|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276154|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276155|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276156|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276157|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276158|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276159|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276160|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276161|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276162|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276163|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276466|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276165|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276166|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276167|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276168|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
276169|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
276170|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
276171|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks.
276172|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
276173|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks.
276174|NCT01313208|E2|Reported Event|Etanercept-Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks. All participants continued their DMARD treatment throughout the 24-week study period.
276175|NCT01313208|E1|Reported Event|Placebo-Etanercept|Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.
276176|NCT01313182|B3|Baseline|Total|Total of all reporting groups
276177|NCT01313182|B2|Baseline|Bactroban Nasal|"Mupirocin calcium ointment, 2%~mupirocin calcium ointment, 2%: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.~After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares."
276178|NCT01313182|B1|Baseline|3M Skin and Nasal Antiseptic|"Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation~Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds."
276179|NCT01313182|P2|Participant Flow|Bactroban Nasal|"Mupirocin calcium ointment, 2%~mupirocin calcium ointment, 2%: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.~After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares."
276180|NCT01313182|P1|Participant Flow|3M Skin and Nasal Antiseptic|"Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation~Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds."
276181|NCT01313182|O2|Outcome|Bactroban Nasal|"Mupirocin calcium ointment, 2%~mupirocin calcium ointment, 2%: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.~After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares."
276182|NCT01313182|O1|Outcome|3M Skin and Nasal Antiseptic|"Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation~Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds."
276183|NCT01313182|E2|Reported Event|Bactroban Nasal|"Mupirocin calcium ointment, 2%~mupirocin calcium ointment, 2%: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.~After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares."
276184|NCT01313182|E1|Reported Event|3M Skin and Nasal Antiseptic|"Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation~Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds."
276185|NCT01313117|B1|Baseline|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)~Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
276186|NCT01313117|P1|Participant Flow|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)~Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
276187|NCT01313117|O1|Outcome|Alpha Lipoic Acid|The study was designed to first explore the optimal ALA dose. The baseline dose was 100 mg three times daily for four months. Dose escalation was to occur until a maximum tolerated dose (MTD) was found. Once the MTD was established we were then to enroll additional patients at the MTD for efficacy analysis. The study failed to reach the MTD. Only small numbers of patients were enrolled. As such, we were unable to perform any meaningful efficacy (TNS) analysis.
276188|NCT01313117|O1|Outcome|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)~Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
276189|NCT01313117|O1|Outcome|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)~Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
276190|NCT01313117|O1|Outcome|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)~Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
276191|NCT01313117|E1|Reported Event|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)~Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
276192|NCT01313078|B1|Baseline|Pegaspargase in Women With Cancer|Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
276193|NCT01313078|P1|Participant Flow|Pegaspargase in Women With Cancer|Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
276194|NCT01313078|O1|Outcome|Pegaspargase in Women With Cancer|Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
276195|NCT01313078|O1|Outcome|Pegaspargase in Women With Cancer|Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
276196|NCT01313078|E1|Reported Event|Pegaspargase in Women With Cancer|Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
276197|NCT01313039|B1|Baseline|AZD6244|AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
276198|NCT01313039|P1|Participant Flow|Single Arm|AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
276199|NCT01313039|O1|Outcome|Single Arm|AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
276200|NCT01313039|E1|Reported Event|Single Arm|AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
276201|NCT01312961|B3|Baseline|Total|Total of all reporting groups
276202|NCT01312961|B2|Baseline|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
276203|NCT01312961|B1|Baseline|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol were given as rescue medication.
276204|NCT01312961|P2|Participant Flow|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
276205|NCT01312961|P1|Participant Flow|Placebo (for Dupilumab)|Placebo (for Dupilumab) subcutaneous (SC) injection once weekly (qw) for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol were given as rescue medication.
276206|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
276207|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
276208|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
276209|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
276210|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
276211|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
276212|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
276213|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
276214|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
276579|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276215|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
276216|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
276217|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
276218|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
276219|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
276220|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
276221|NCT01312961|O1|Outcome|Placebo|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
276222|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
276223|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
276224|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
276225|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
276226|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
276227|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
276228|NCT01312961|E2|Reported Event|Dupilumab 300 mg qw|Participants exposed to Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (mean exposure of 11 weeks).
276229|NCT01312961|E1|Reported Event|Placebo (for Dupilumab)|Participants exposed to Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (mean exposure of 11 weeks).
276230|NCT01312948|B1|Baseline|Prototype Mask|New paediatric mask system (Pixi) designed for children aged 2-7 years using Positive airway pressure (PAP) therapy
276231|NCT01312948|P1|Participant Flow|Prototype Mask|New paediatric mask system (Pixi) designed for children aged 2-7 years using Positive airway pressure (PAP) therapy
276232|NCT01312948|O2|Outcome|Usual Mask|Apnea hypopnoea index from a monitored sleep study of the child's usual CPAP mask. An apnea hypopnoea index of <5 demonstrates treatment efficacy
276233|NCT01312948|O1|Outcome|Pixi Paediatric Mask|Apnea hypopnoea index from a monitored sleep study of the new Pixi mask. An apnea hypopnoea index of <5 demonstrates treatment efficacy
276234|NCT01312948|O2|Outcome|Usual Mask|Usability (overall performance) score of the child's usual CPAP mask
276235|NCT01312948|O1|Outcome|Pixi Paediatric Mask Usability|Usability (overall performance) score of the Pixi paediatric mask
276236|NCT01312948|E1|Reported Event|Prototype Mask|New paediatric mask system (Pixi) designed for children aged 2-7 years using Positive airway pressure (PAP) therapy
276237|NCT01312844|B3|Baseline|Total|Total of all reporting groups
276238|NCT01312844|B2|Baseline|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
276239|NCT01312844|B1|Baseline|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
276240|NCT01312844|P2|Participant Flow|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
276241|NCT01312844|P1|Participant Flow|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
314117|NCT01211145|O4|Outcome|ZOMIG 5 mg|ZOMIG nasal spray
276242|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
276243|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
276244|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
276245|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
276246|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
276247|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
276248|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
276249|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
276250|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
276251|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
276252|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
276253|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
276254|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
276255|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
276256|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
276257|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
276258|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
276259|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
276260|NCT01312844|E2|Reported Event|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
276261|NCT01312844|E1|Reported Event|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
276262|NCT01312818|B1|Baseline|Chemotherapy|"bortezomib, vorinostat and dexamethasone combination, as well as intrathecal methotrexate and imatinib mesylate.~Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.~Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14~Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.~Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)~Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:~Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
276263|NCT01312818|P1|Participant Flow|Chemotherapy|"bortezomib, vorinostat and dexamethasone combination, as well as intrathecal methotrexate and imatinib mesylate.~Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.~Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14~Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.~Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)~Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:~Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
276264|NCT01312818|O1|Outcome|Chemotherapy|"Bortezomib IV Vorinostat PO Dexamethasone PO Intrathecal Methotrexate Imatinib Mesylate PO (for Ph+ ALL patients only)~Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.~Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14~Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.~Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)~Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:~Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
276265|NCT01312818|O1|Outcome|ALL Treated Patients|"List of toxicities in acute lymphoblastic leukemia (ALL) patients treated with bortezomib, vorinostat and dexamethasone combination, as well as intrathecal methotrexate and imatinib mesylate.~Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.~Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14~Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.~Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)~Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:~Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
276266|NCT01312818|O1|Outcome|ALL Treated Patients|"bortezomib, vorinostat and dexamethasone combination, as well as intrathecal methotrexate and imatinib mesylate.~Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.~Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14~Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.~Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)~Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:~Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
276267|NCT01312818|E1|Reported Event|Chemotherapy|"bortezomib, vorinostat and dexamethasone combination, as well as intrathecal methotrexate and imatinib mesylate.~Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.~Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14~Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.~Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)~Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:~Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
276268|NCT01312805|B3|Baseline|Total|Total of all reporting groups
276269|NCT01312805|B2|Baseline|CHICA Asthma Module|"This arm received the CHICA asthma module~CHICA Asthma Module: This module was added to CHICA to help diagnose and manage asthma"
276270|NCT01312805|B1|Baseline|CHICA Control|"This arm received CHICA without the asthma module~CHICA Control: This is CHICA without the asthma module, and was used as a control"
276271|NCT01312805|P2|Participant Flow|CHICA Asthma Module|"This arm received the CHICA asthma module~CHICA Asthma Module: This module was added to CHICA to help diagnose and manage asthma"
276272|NCT01312805|P1|Participant Flow|CHICA Control|"This arm received CHICA without the asthma module~CHICA Control: This is CHICA without the asthma module, and was used as a control"
276273|NCT01312805|O2|Outcome|CHICA Asthma Module|"This arm received the CHICA asthma module~CHICA Asthma Module: This module was added to CHICA to help diagnose and manage asthma"
276274|NCT01312805|O1|Outcome|CHICA Control|"This arm received CHICA without the asthma module~CHICA Control: This is CHICA without the asthma module, and was used as a control"
276275|NCT01312805|E2|Reported Event|CHICA Asthma Module|"This arm received the CHICA asthma module~CHICA Asthma Module: This module was added to CHICA to help diagnose and manage asthma"
276276|NCT01312805|E1|Reported Event|CHICA Control|"This arm received CHICA without the asthma module~CHICA Control: This is CHICA without the asthma module, and was used as a control"
276277|NCT01312766|B3|Baseline|Total|Total of all reporting groups
276278|NCT01312766|B2|Baseline|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
276279|NCT01312766|B1|Baseline|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
276280|NCT01312766|P2|Participant Flow|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
276281|NCT01312766|P1|Participant Flow|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
276282|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
276283|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
276284|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
276285|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
276286|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
276287|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
276288|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
276289|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
276290|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
276291|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
276292|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
276293|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
276294|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
276295|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
276296|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
276297|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
276298|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
276299|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
276300|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
276301|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
276302|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
276303|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
276307|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
276308|NCT01312766|E2|Reported Event|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
276309|NCT01312766|E1|Reported Event|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
276310|NCT01312519|B3|Baseline|Total|Total of all reporting groups
276311|NCT01312519|B2|Baseline|OnControl Bone Marrow System|Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
276312|NCT01312519|B1|Baseline|Manual Bone Marrow Sampling Device|Hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.
276313|NCT01312519|P2|Participant Flow|OnControl Bone Marrow System|Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
276314|NCT01312519|P1|Participant Flow|Manual Bone Marrow Sampling Device|hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.
276315|NCT01312519|O2|Outcome|OnControl Bone Marrow System|Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
276316|NCT01312519|O1|Outcome|Manual Bone Marrow Sampling Device|hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.
276317|NCT01312519|O2|Outcome|OnControl Bone Marrow System|Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
276318|NCT01312519|O1|Outcome|Manual Bone Marrow Sampling Device|hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.
276319|NCT01312519|E2|Reported Event|OnControl Bone Marrow System|Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
276320|NCT01312519|E1|Reported Event|Manual Bone Marrow Sampling Device|hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.
276321|NCT01312467|B1|Baseline|Prevention (Metformin Hydrochloride)|"Patients receive metformin hydrochloride PO QD during week 1 and then BID during weeks 2-12. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.~metformin hydrochloride: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
276322|NCT01312467|P1|Participant Flow|Prevention (Metformin Hydrochloride)|"Patients receive metformin hydrochloride PO QD during week 1 and then BID during weeks 2-12. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.~metformin hydrochloride: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
276323|NCT01312467|O1|Outcome|Prevention (Metformin Hydrochloride)|"Patients receive metformin hydrochloride PO QD during week 1 and then BID during weeks 2-12. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.~metformin hydrochloride"
276324|NCT01312467|O1|Outcome|Prevention (Metformin Hydrochloride)|"Patients receive metformin hydrochloride PO QD during week 1 and then BID during weeks 2-12. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.~metformin hydrochloride"
276325|NCT01312467|O1|Outcome|Prevention (Metformin Hydrochloride)|"Patients receive metformin hydrochloride PO QD during week 1 and then BID during weeks 2-12. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.~metformin hydrochloride"
276326|NCT01312467|O1|Outcome|Prevention (Metformin Hydrochloride)|"Patients receive metformin hydrochloride PO QD during week 1 and then BID during weeks 2-12. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.~metformin hydrochloride: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
276327|NCT01312467|E1|Reported Event|Prevention (Metformin Hydrochloride)|"Patients receive metformin hydrochloride PO QD during week 1 and then BID during weeks 2-12. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.~metformin hydrochloride: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
276328|NCT01312428|B3|Baseline|Total|Total of all reporting groups
276329|NCT01312428|B2|Baseline|No PAL (No Pelvic Alignment Level)|"The cases randomized into the no PAL group will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group.~Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument."
276330|NCT01312428|B1|Baseline|PAL (Pelvic Alignment Level)|"The cases randomized into the PAL group will have total hip replacement surgery performed utilizing the PAL instrument.~Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument."
276331|NCT01312428|P2|Participant Flow|No PAL (No Pelvic Alignment Level)|"The cases randomized into the No PAL Group will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group.~Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument."
276332|NCT01312428|P1|Participant Flow|PAL (Pelvic Alignment Level)|"The cases randomized into the PAL Group will have total hip replacement surgery performed utilizing the PAL instrument.~Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument."
276333|NCT01312428|O2|Outcome|No PAL (No Pelvic Alignment Level)|"The cases randomized into the No PAL Group will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group.~Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument."
276334|NCT01312428|O1|Outcome|PAL (Pelvic Alignment Level)|"The cases randomized into the PAL Group will have total hip replacement surgery performed utilizing the PAL instrument.~Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument."
276467|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276468|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276335|NCT01312428|O2|Outcome|No PAL (No Pelvic Alignment Level)|"The cases randomized into the no PAL group will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group.~Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument."
276336|NCT01312428|O1|Outcome|PAL (Pelvic Alignment Level)|"The cases randomized into the PAL group will have total hip replacement surgery performed utilizing the PAL instrument.~Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument."
276337|NCT01312428|E2|Reported Event|No PAL (No Pelvic Alignment Level)|"The cases randomized into the no PAL group will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group.~Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument."
276338|NCT01312428|E1|Reported Event|PAL (Pelvic Alignment Level)|"The cases randomized into the PAL group will have total hip replacement surgery performed utilizing the PAL instrument.~Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument."
276339|NCT01312272|B3|Baseline|Total|Total of all reporting groups
276340|NCT01312272|B2|Baseline|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
276341|NCT01312272|B1|Baseline|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
276342|NCT01312272|P2|Participant Flow|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
276343|NCT01312272|P1|Participant Flow|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
276344|NCT01312272|O2|Outcome|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
276345|NCT01312272|O1|Outcome|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
276346|NCT01312272|O2|Outcome|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
276347|NCT01312272|O1|Outcome|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
276348|NCT01312272|O2|Outcome|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
276349|NCT01312272|O1|Outcome|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
276350|NCT01312272|O2|Outcome|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
276351|NCT01312272|O1|Outcome|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
276352|NCT01312272|O2|Outcome|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
276353|NCT01312272|O1|Outcome|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
314118|NCT01211145|O3|Outcome|ZOMIG 2.5 mg|ZOMIG nasal spray
276354|NCT01312272|O2|Outcome|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
276355|NCT01312272|O1|Outcome|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
276356|NCT01312272|E2|Reported Event|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
276357|NCT01312272|E1|Reported Event|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
276358|NCT01312181|B4|Baseline|Total|Total of all reporting groups
276359|NCT01312181|B3|Baseline|HIV/AIDS Health Education - DVD Control|"HIV/AIDS health education - DVD control. The purpose of this condition is to control for clinical attention associated with Motivational Interviewing (MI)participation, and to provide an analogue of standard care, i.e. brief advice but no other intervention.~HIV/AIDS health education: A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
276360|NCT01312181|B2|Baseline|Motivational Interviewing (MI)|"The MI session focuses on reduce ambivalence and increase motivation to reduce non-injection drug use (NIDU), gain a commitment to change, if possible, and ultimately to reduce or eliminate NIDU. The intervention includes: a) identifying pros and cons of using and stopping; b) exploring ambivalence about stopping NIDU; c) eliciting change talk~Motivational Interviewing (MI): A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
276361|NCT01312181|B1|Baseline|HealthCall +Motivational Interviewing|"Patients access HealthCall by calling a toll-free number and putting a four-digit Personal Identification Number (PIN). The HealthCall system will then ask a short script of pre-recorded questions in English or Spanish, on substance use and other variables (e.g., medication adherence, unprotected sex, feeling of physical well-being, stress, etc).~HealthCall and Motivational Interviewing: A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
276362|NCT01312181|P3|Participant Flow|HIV/AIDS Health Education - DVD Control|"HIV/AIDS health education - DVD control. The purpose of this condition is to control for clinical attention associated with Motivational Interviewing (MI)participation, and to provide an analogue of standard care, i.e. brief advice but no other intervention.~HIV/AIDS health education: A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
276363|NCT01312181|P2|Participant Flow|Motivational Interviewing (MI)|"The MI session focuses on reduce ambivalence and increase motivation to reduce non-injection drug use (NIDU), gain a commitment to change, if possible, and ultimately to reduce or eliminate NIDU. The intervention includes: a) identifying pros and cons of using and stopping; b) exploring ambivalence about stopping NIDU; c) eliciting change talk~Motivational Interviewing (MI): A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
276364|NCT01312181|P1|Participant Flow|HealthCall +Motivational Interviewing|"Patients access HealthCall by calling a toll-free number and putting a four-digit Personal Identification Number (PIN). The HealthCall system will then ask a short script of pre-recorded questions in English or Spanish, on substance use and other variables (e.g., medication adherence, unprotected sex, feeling of physical well-being, stress, etc).~HealthCall and Motivational Interviewing: A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
276365|NCT01312181|O3|Outcome|HIV/AIDS Health Education - DVD Control|"HIV/AIDS health education - DVD control. The purpose of this condition is to control for clinical attention associated with Motivational Interviewing (MI)participation, and to provide an analogue of standard care, i.e. brief advice but no other intervention.~HIV/AIDS health education: A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
276366|NCT01312181|O2|Outcome|Motivational Interviewing (MI)|"The MI session focuses on reduce ambivalence and increase motivation to reduce non-injection drug use (NIDU), gain a commitment to change, if possible, and ultimately to reduce or eliminate NIDU. The intervention includes: a) identifying pros and cons of using and stopping; b) exploring ambivalence about stopping NIDU; c) eliciting change talk~Motivational Interviewing (MI): A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
276367|NCT01312181|O1|Outcome|HealthCall +Motivational Interviewing|"Patients access HealthCall by calling a toll-free number and putting a four-digit Personal Identification Number (PIN). The HealthCall system will then ask a short script of pre-recorded questions in English or Spanish, on substance use and other variables (e.g., medication adherence, unprotected sex, feeling of physical well-being, stress, etc).~HealthCall and Motivational Interviewing: A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
276469|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276667|NCT01311102|O1|Outcome|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine
276368|NCT01312181|O3|Outcome|HIV/AIDS Health Education - DVD Control|"HIV/AIDS health education - DVD control. The purpose of this condition is to control for clinical attention associated with Motivational Interviewing (MI)participation, and to provide an analogue of standard care, i.e. brief advice but no other intervention.~HIV/AIDS health education: A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
276369|NCT01312181|O2|Outcome|Motivational Interviewing (MI)|"The MI session focuses on reduce ambivalence and increase motivation to reduce non-injection drug use (NIDU), gain a commitment to change, if possible, and ultimately to reduce or eliminate NIDU. The intervention includes: a) identifying pros and cons of using and stopping; b) exploring ambivalence about stopping NIDU; c) eliciting change talk~Motivational Interviewing (MI): A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
276370|NCT01312181|O1|Outcome|HealthCall +Motivational Interviewing|"Patients access HealthCall by calling a toll-free number and putting a four-digit Personal Identification Number (PIN). The HealthCall system will then ask a short script of pre-recorded questions in English or Spanish, on substance use and other variables (e.g., medication adherence, unprotected sex, feeling of physical well-being, stress, etc).~HealthCall and Motivational Interviewing: A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
276371|NCT01312181|E3|Reported Event|HIV/AIDS Health Education - DVD Control|"HIV/AIDS health education - DVD control. The purpose of this condition is to control for clinical attention associated with Motivational Interviewing (MI)participation, and to provide an analogue of standard care, i.e. brief advice but no other intervention.~HIV/AIDS health education: A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
276372|NCT01312181|E2|Reported Event|Motivational Interviewing (MI)|"The MI session focuses on reduce ambivalence and increase motivation to reduce non-injection drug use (NIDU), gain a commitment to change, if possible, and ultimately to reduce or eliminate NIDU. The intervention includes: a) identifying pros and cons of using and stopping; b) exploring ambivalence about stopping NIDU; c) eliciting change talk~Motivational Interviewing (MI): A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
276373|NCT01312181|E1|Reported Event|HealthCall +Motivational Interviewing|"Patients access HealthCall by calling a toll-free number and putting a four-digit Personal Identification Number (PIN). The HealthCall system will then ask a short script of pre-recorded questions in English or Spanish, on substance use and other variables (e.g., medication adherence, unprotected sex, feeling of physical well-being, stress, etc).~HealthCall and Motivational Interviewing: A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm."
276374|NCT01312129|B3|Baseline|Total|Total of all reporting groups
276375|NCT01312129|B2|Baseline|Sulfasalazine First, Then Placebo|Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the first session (Sulfasalazine 1500mg total) followed by a washout period of 7 days, then Placebo capsule x 3 doses 12 hours apart in the second session.
276376|NCT01312129|B1|Baseline|Placebo First, Then Sulfasalazine|Placebo x 3 doses 12 hours apart in the first session, followed by a washout period of 7 days, then Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the second session (Sulfasalazine 1500mg total)
276377|NCT01312129|P2|Participant Flow|Sulfasalazine First, Then Placebo|Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the first session (Sulfasalazine 1500mg total) followed by a washout period of 7 days, then Placebo capsule x 3 doses 12 hours apart in the second session.
276378|NCT01312129|P1|Participant Flow|Placebo First, Then Sulfasalzine|Placebo x 3 doses 12 hours apart in the first session, followed by a washout period of 7 days, then Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the second session (Sulfasalazine 1500mg total)
276379|NCT01312129|O2|Outcome|Sulfasalazine|Sulfasalazine capsule, 500mg, x 3 doses 12 hours.
276380|NCT01312129|O1|Outcome|Placebo|Placebo x 3 doses 12 hours apart
276381|NCT01312129|E2|Reported Event|Sulfasalazine First, Then Placebo|Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the first session (Sulfasalazine 1500mg total) followed by a washout period of 7 days, then Placebo capsule x 3 doses 12 hours apart in the second session.
276382|NCT01312129|E1|Reported Event|Placebo First, Then Sulfasalazine|Placebo x 3 doses 12 hours apart in the first session, followed by a washout period of 7 days, then Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the second session (Sulfasalazine 1500mg total)
276383|NCT01312038|B3|Baseline|Total|Total of all reporting groups
276384|NCT01312038|B2|Baseline|Placebo|"chewable calcium tablet~Placebo: chewable calcium tablet"
276385|NCT01312038|B1|Baseline|Simethicone|"125 mg tablet~Simethicone: single 125 mg chewable tablet"
276386|NCT01312038|P2|Participant Flow|Placebo|"chewable calcium tablet~Placebo: chewable calcium tablet"
276387|NCT01312038|P1|Participant Flow|Simethicone|"125 mg tablet~Simethicone: single 125 mg chewable tablet"
276388|NCT01312038|O2|Outcome|Placebo|Outcome measure in each evaluable ear
276389|NCT01312038|O1|Outcome|Simethicone-treated|Outcome measure in each evaluable ear.
276390|NCT01312038|E2|Reported Event|Placebo|"chewable calcium tablet~Placebo: chewable calcium tablet"
276391|NCT01312038|E1|Reported Event|Simethicone|"125 mg tablet~Simethicone: single 125 mg chewable tablet"
276392|NCT01311895|B3|Baseline|Total|Total of all reporting groups
276393|NCT01311895|B2|Baseline|1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone)|"1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the following question: Do you want more pain medication?~1+1: 1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?"
276394|NCT01311895|B1|Baseline|H2O (2 mg IV Hydromorphone)|"2 mg IV hydromorphone~H2O: 2 mg IV hydromorphone"
276470|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276395|NCT01311895|P2|Participant Flow|1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone)|"1 mg intravenous (IV) hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the following question: Do you want more pain medication?~1+1: 1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?"
276396|NCT01311895|P1|Participant Flow|H2O (2 mg IV Hydromorphone)|"2 mg IV hydromorphone~H2O: 2 mg intravenous (IV) hydromorphone"
276397|NCT01311895|O2|Outcome|1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone)|"1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the following question: Do you want more pain medication?~1+1: 1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?"
276398|NCT01311895|O1|Outcome|H2O (2 mg IV Hydromorphone)|"2 mg IV hydromorphone administered over 2-3 minutes as initial dose~H2O: 2 mg IV hydromorphone"
276399|NCT01311895|O2|Outcome|1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone)|"1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the following question: Do you want more pain medication?~1+1: 1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?"
276400|NCT01311895|O1|Outcome|H2O (2 mg IV Hydromorphone)|"2 mg IV hydromorphone administered over 2-3 minutes as initial dose~H2O: 2 mg IV hydromorphone"
276401|NCT01311895|O2|Outcome|1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone)|"1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the following question: Do you want more pain medication?~1+1: 1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?"
276402|NCT01311895|O1|Outcome|H2O (2 mg IV Hydromorphone)|"2 mg IV hydromorphone administered over 2-3 minutes as initial dose~H2O: 2 mg IV hydromorphone"
276403|NCT01311895|E2|Reported Event|1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone)|"1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the following question: Do you want more pain medication?~1+1: 1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?"
276404|NCT01311895|E1|Reported Event|H2O (2 mg IV Hydromorphone)|"2 mg IV hydromorphone~H2O: 2 mg IV hydromorphone"
276405|NCT01311687|B3|Baseline|Total|Total of all reporting groups
276406|NCT01311687|B2|Baseline|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
276407|NCT01311687|B1|Baseline|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
276408|NCT01311687|P2|Participant Flow|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
276409|NCT01311687|P1|Participant Flow|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
276410|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
276411|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
276412|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
276413|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
276414|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
276415|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
276416|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
276417|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
276418|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
276471|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276419|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
276420|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
276421|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
276422|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
276423|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
276424|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
276425|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
276426|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
276427|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
276428|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
276429|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
276430|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
276431|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
276432|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
276433|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
276434|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
276435|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
276436|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
276437|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
276438|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
276439|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
276440|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
276472|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276441|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
276442|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
276443|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
276444|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
276445|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
276446|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
276447|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
276448|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
276449|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
276450|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
276451|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
276452|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
276453|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
276454|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
276455|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
276456|NCT01311687|E2|Reported Event|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
276457|NCT01311687|E1|Reported Event|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
276458|NCT01311661|B1|Baseline|Study Total|This was a double-blind, 3-period crossover trial. 206 patients were assigned randomly to one of 12 treatment sequences with either 5 microgram (mcg) Olodaterol (Olo) once daily (qd) and 2.5 mcg Olodaterol twice daily (bid) and placebo (6 sequences) or 10 mcg Olodaterol qd and 5 mcg Olodaterol bid and placebo (6 sequences). The duration of each treatment period was 3 weeks separated by washout periods of 2 weeks.
276459|NCT01311661|P1|Participant Flow|Study Total|This was a double-blind, 3-period crossover trial. 206 patients were assigned randomly to one of 12 treatment sequences with either 5 microgram (mcg) Olodaterol (Olo) once daily (qd) and 2.5 mcg Olodaterol twice daily (bid) and placebo (6 sequences) or 10 mcg Olodaterol qd and 5 mcg Olodaterol bid and placebo (6 sequences). The duration of each treatment period was 3 weeks separated by washout periods of 2 weeks.
276460|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276461|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276462|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276463|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276464|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276465|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276475|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276476|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276477|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276478|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276479|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276480|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276481|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276482|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276483|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276484|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276485|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276486|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276487|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276488|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276489|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276490|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276491|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276492|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276493|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276494|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276495|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276496|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276497|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276498|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276499|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276500|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276501|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276502|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276503|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276504|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276505|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276506|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276507|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276508|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276509|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276510|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276511|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276512|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276513|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276514|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276515|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276516|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276517|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276518|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276519|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276520|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276521|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276522|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276523|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276524|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276525|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276526|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276668|NCT01311102|O2|Outcome|Normal Saline|Normal Saline : 1.33cc of normal saline
276527|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276528|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276529|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276530|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276531|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276532|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276533|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276534|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276535|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276536|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276537|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276538|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276539|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276540|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276541|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276542|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276543|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276544|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276545|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276546|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276547|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276548|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276549|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276550|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276551|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276552|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276553|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276554|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276555|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276556|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276557|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276558|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276559|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276560|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276561|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276562|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276563|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276564|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276565|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276566|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276567|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276568|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276569|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276570|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276571|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276572|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276573|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276574|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276575|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276576|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276577|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276578|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276669|NCT01311102|O1|Outcome|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine
276580|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276581|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276582|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276583|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276584|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276585|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276586|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276587|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276588|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276589|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276590|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276591|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276592|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276593|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276594|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276595|NCT01311661|E5|Reported Event|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276596|NCT01311661|E4|Reported Event|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
276597|NCT01311661|E3|Reported Event|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
276598|NCT01311661|E2|Reported Event|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
276599|NCT01311661|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
276600|NCT01311557|B3|Baseline|Total|Total of all reporting groups
276601|NCT01311557|B2|Baseline|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
276602|NCT01311557|B1|Baseline|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
276603|NCT01311557|P2|Participant Flow|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
276604|NCT01311557|P1|Participant Flow|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
276605|NCT01311557|O2|Outcome|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
276606|NCT01311557|O1|Outcome|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
276607|NCT01311557|O2|Outcome|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
276608|NCT01311557|O1|Outcome|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
276609|NCT01311557|O2|Outcome|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
276610|NCT01311557|O1|Outcome|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
276611|NCT01311557|O2|Outcome|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
276612|NCT01311557|O1|Outcome|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
276613|NCT01311557|O2|Outcome|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
276614|NCT01311557|O1|Outcome|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
276615|NCT01311557|O2|Outcome|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
276616|NCT01311557|O1|Outcome|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
276617|NCT01311557|E2|Reported Event|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
276618|NCT01311557|E1|Reported Event|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
276619|NCT01311505|B1|Baseline|Participants Eligible for Analysis|Includes participants randomized to receive Myrin 2 first and Rimactane first and who had completed the study. It excludes 1 participant who did not meet the weight requirement for the study (protocol violator).
276620|NCT01311505|P2|Participant Flow|Rimactane First, Then Myrin 2|Single oral dose of Rimactane capsule (300 mg rifampicin) in first intervention period; and single oral dose of 2 FDC tablets of Myrin 2 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) in second intervention period. A washout period of at least 7 days was maintained between each period.
276621|NCT01311505|P1|Participant Flow|Myrin 2 First, Then Rimactane|Single oral dose of 2 fixed dose combination (FDC) tablets of Myrin 2 (each tablet contains 150 milligram (mg) rifampicin and 75 mg isoniazid) in first intervention period, and single oral dose of Rimactane capsule (300 mg rifampicin) in second intervention period. A washout period of at least 7 days was maintained between each period.
276622|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
276623|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
276624|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
276625|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
276626|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
276627|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
276628|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
276629|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
276630|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
276631|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
276632|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
276633|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
276634|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.
276635|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.
276636|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.
276637|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.
276638|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.
276639|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.
276640|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.
276641|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.
276642|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane capsule (300 mg capsule) in either first intervention period or second intervention period.
276643|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.
276644|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.
276645|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.
276646|NCT01311505|E2|Reported Event|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
276647|NCT01311505|E1|Reported Event|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
276648|NCT01311362|B1|Baseline|Ambrisentan|administration of ambrisentan 5 mg p.o. single dose administration of ambrisentan 5 mg p.o. q.d. on day 3-10 administration of ambrisentan 5 mg p.o. q.d on day 11-20 and administration of SJW 300 mg p.o. t.i.d. on day 11-20
276649|NCT01311362|P1|Participant Flow|Ambrisentan After First Dose|administration of ambrisentan 5 mg p.o. single dose administration of ambrisentan 5 mg p.o. q.d. on day 3-10 administration of ambrisentan 5 mg p.o. q.d on day 11-20 and administration of SJW 300 mg p.o. t.i.d. on day 11-20
276650|NCT01311362|O3|Outcome|Ambrisentan During St John's Wort|administration of ambrisentan 5 mg p.o. q.d. on day 11-20 and administration of SJW 300 mg p.o. t.i.d. on day 11-20
276651|NCT01311362|O2|Outcome|Ambrisentan at Steady-state|administration of ambrisentan 5 mg p.o. q.d. on day 3-10
276652|NCT01311362|O1|Outcome|Ambrisentan After First Dose|administration of ambrisentan 5 mg p.o. single dose
276653|NCT01311362|O3|Outcome|Ambrisentan During St John's Wort|administration of ambrisentan 5 mg p.o. q.d. on day 11-20 and administration of SJW 300 mg t.i.d. on day 11-20
276654|NCT01311362|O2|Outcome|Ambrisentan at Steady-state|administration of ambrisentan 5 mg p.o. q.d. on day 3-10
276655|NCT01311362|O1|Outcome|Ambrisentan After First Dose|administration of ambrisentan 5 mg p.o. single dose
276656|NCT01311362|E3|Reported Event|Ambrisentan During St John's Wort|administration of ambrisentan 5 mg p.o. q.d. on day 11-20 and administration of SJW 300 mg p.o. t.i.d. on day 11-20
276657|NCT01311362|E2|Reported Event|Ambrisentan at Steady-state|administration of ambrisentan 5 mg p.o. q.d. on day 3-10
276658|NCT01311362|E1|Reported Event|Ambrisentan After First Dose|administration of ambrisentan 5 mg p.o. single dose
276659|NCT01311102|B3|Baseline|Total|Total of all reporting groups
276660|NCT01311102|B2|Baseline|Normal Saline|Normal Saline : 1.33cc of normal saline
276661|NCT01311102|B1|Baseline|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine
276662|NCT01311102|P2|Participant Flow|Normal Saline|Normal Saline : 1.33cc of normal saline
276663|NCT01311102|P1|Participant Flow|Lidocaine|Lidocaine : 1.33 cc of 2% liquid lidocaine
276664|NCT01311102|O2|Outcome|Normal Saline|Normal Saline : 1.33cc of normal saline infused in endo cervix and endometrium.
276665|NCT01311102|O1|Outcome|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine infused in endo cervix and endometrium
276666|NCT01311102|O2|Outcome|Normal Saline|Normal Saline : 1.33cc of normal saline
276671|NCT01311102|O1|Outcome|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine
276672|NCT01311102|E2|Reported Event|Normal Saline|Normal Saline : 1.33cc of normal saline
276673|NCT01311102|E1|Reported Event|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine
276674|NCT01311024|B3|Baseline|Total|Total of all reporting groups
276675|NCT01311024|B2|Baseline|Control-vaccinated Sibling|"Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~hepatitis B vaccine or hepatitis A vaccine: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)"
276676|NCT01311024|B1|Baseline|PCV-vaccinated Sibling (GSK1024850A)|"Older sibling of a child vaccinated with PCV in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Pneumococcal conjugate vaccine GSK1024850A: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)"
276677|NCT01311024|P2|Participant Flow|Control-vaccinated Sibling|"Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~hepatitis B vaccine or hepatitis A vaccine: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Evaluable subjects with NPS sample analysed 518 Siblings of infant-vaccinated children in the control arms and 271 Siblings of catch-up vaccinated children 789 in total"
276678|NCT01311024|P1|Participant Flow|PCV-vaccinated Sibling (GSK1024850A)|"Older sibling of a child vaccinated with PCV in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Pneumococcal conjugate vaccine GSK1024850A: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380).~Evaluable subjects with NPS sample analysed 482 Siblings of infant-vaccinated children in the PCV 2+1 arm and 445 Siblings of infant-vaccinated children in the PCV 3+1 arm and 568 Siblings of catch-up vaccinated children in the PCV arms 1495 in total"
276679|NCT01311024|O2|Outcome|Control-vaccinated Sibling|"Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~hepatitis B vaccine or hepatitis A vaccine: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Evaluable subjects with NPS sample analysed 518 Siblings of infant-vaccinated children in the control arms and 271 Siblings of catch-up vaccinated children 789 in total"
276680|NCT01311024|O1|Outcome|PCV-vaccinated Sibling (GSK1024850A)|"Older sibling of a child vaccinated with PCV in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Pneumococcal conjugate vaccine GSK1024850A: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380).~Evaluable subjects with NPS sample analysed 482 Siblings of infant-vaccinated children in the PCV 2+1 arm and 445 Siblings of infant-vaccinated children in the PCV 3+1 arm and 568 Siblings of catch-up vaccinated children in the PCV arms 1495 in total"
276681|NCT01311024|E2|Reported Event|Control-vaccinated Sibling|"Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~hepatitis B vaccine or hepatitis A vaccine: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Evaluable subjects with NPS sample analysed 518 Siblings of infant-vaccinated children in the control arms and 271 Siblings of catch-up vaccinated children 789 in total"
276682|NCT01311024|E1|Reported Event|PCV-vaccinated Sibling (GSK1024850A)|"Older sibling of a child vaccinated with PCV in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Pneumococcal conjugate vaccine GSK1024850A: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380).~Evaluable subjects with NPS sample analysed 482 Siblings of infant-vaccinated children in the PCV 2+1 arm and 445 Siblings of infant-vaccinated children in the PCV 3+1 arm and 568 Siblings of catch-up vaccinated children in the PCV arms 1495 in total"
276683|NCT01310868|B1|Baseline|5-ALA and Gliadel Wafers|"This is a single arm feasibility study to evaluate the safety and tolerability of combining 2 technologies (5-ALA and Gliadel wafers) in the surgical management of patients with GBM.~5-ALA: 5-ALA is used to generate tumour specific fluorescence as an aid to surgical resection of GBM, prior to the insertion of Gliadel wafers~Gliadel wafers: The implantation of Carmustine Wafers (Gliadel) delivers carmustine- (3-bis 2-chloroethyl 1-1-nitrosourea (BCNU)) directly into the surgical cavity created after tumour resection."
276684|NCT01310868|P1|Participant Flow|5-ALA and Gliadel Wafers|"This is a single arm feasibility study to evaluate the safety and tolerability of combining 2 technologies (5-ALA and Gliadel wafers) in the surgical management of patients with GBM.~5-ALA: 5-ALA is used to generate tumour specific fluorescence as an aid to surgical resection of GBM, prior to the insertion of Gliadel wafers~Gliadel wafers: The implantation of Carmustine Wafers (Gliadel) delivers carmustine- (3-bis 2-chloroethyl 1-1-nitrosourea (BCNU)) directly into the surgical cavity created after tumour resection."
276685|NCT01310868|O1|Outcome|5-ALA and Gliadel Wafers|"This is a single arm feasibility study to evaluate the safety and tolerability of combining 2 technologies (5-ALA and Gliadel wafers) in the surgical management of patients with GBM.~5-ALA: 5-ALA is used to generate tumour specific fluorescence as an aid to surgical resection of GBM, prior to the insertion of Gliadel wafers~Gliadel wafers: The implantation of Carmustine Wafers (Gliadel) delivers carmustine- (3-bis 2-chloroethyl 1-1-nitrosourea (BCNU)) directly into the surgical cavity created after tumour resection."
276686|NCT01310868|O1|Outcome|5-ALA and Gliadel Wafers|"This is a single arm feasibility study to evaluate the safety and tolerability of combining 2 technologies (5-ALA and Gliadel wafers) in the surgical management of patients with GBM.~5-ALA: 5-ALA is used to generate tumour specific fluorescence as an aid to surgical resection of GBM, prior to the insertion of Gliadel wafers~Gliadel wafers: The implantation of Carmustine Wafers (Gliadel) delivers carmustine- (3-bis 2-chloroethyl 1-1-nitrosourea (BCNU)) directly into the surgical cavity created after tumour resection."
314119|NCT01211145|O2|Outcome|ZOMIG 0.5 mg|ZOMIG nasal spray
276687|NCT01310868|O1|Outcome|5-ALA and Gliadel Wafers|"This is a single arm feasibility study to evaluate the safety and tolerability of combining 2 technologies (5-ALA and Gliadel wafers) in the surgical management of patients with GBM.~5-ALA: 5-ALA is used to generate tumour specific fluorescence as an aid to surgical resection of GBM, prior to the insertion of Gliadel wafers~Gliadel wafers: The implantation of Carmustine Wafers (Gliadel) delivers carmustine- (3-bis 2-chloroethyl 1-1-nitrosourea (BCNU)) directly into the surgical cavity created after tumour resection."
276688|NCT01310868|E1|Reported Event|5-ALA and Gliadel Wafers|"This is a single arm feasibility study to evaluate the safety and tolerability of combining 2 technologies (5-ALA and Gliadel wafers) in the surgical management of patients with GBM.~5-ALA: 5-ALA is used to generate tumour specific fluorescence as an aid to surgical resection of GBM, prior to the insertion of Gliadel wafers~Gliadel wafers: The implantation of Carmustine Wafers (Gliadel) delivers carmustine- (3-bis 2-chloroethyl 1-1-nitrosourea (BCNU)) directly into the surgical cavity created after tumour resection."
276689|NCT01310855|B3|Baseline|Total|Total of all reporting groups
276690|NCT01310855|B2|Baseline|Cediranbib & Placebo|"Cediranib maleate 30mg od orally and placebo 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~cediranib maleate~Placebo"
276691|NCT01310855|B1|Baseline|Cediranib & Gefitinib|"Cediranib maleate 30mg od orally and gefitinib 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~cediranib maleate~gefitinib"
276692|NCT01310855|P2|Participant Flow|Cediranbib & Placebo|"Cediranib maleate 30mg od orally and placebo 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~cediranib maleate~Placebo"
276693|NCT01310855|P1|Participant Flow|Cediranib & Gefitinib|"Cediranib maleate 30mg od orally and gefitinib 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~cediranib maleate~gefitinib"
276694|NCT01310855|O2|Outcome|Cediranbib & Placebo|"Cediranib maleate 30mg od orally and placebo 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~cediranib maleate~Placebo"
276695|NCT01310855|O1|Outcome|Cediranib & Gefitinib|"Cediranib maleate 30mg od orally and gefitinib 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~cediranib maleate~gefitinib"
276696|NCT01310855|E2|Reported Event|Cediranbib & Placebo|"Cediranib maleate 30mg od orally and placebo 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~Due to the early discontinuation of Cediranib by AZ, the trial was discontinued early so that only 38 patients (19 per arm) were recruited."
276697|NCT01310855|E1|Reported Event|Cediranib & Gefitinib|"Cediranib maleate 30mg od orally and gefitinib 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~Due to the early discontinuation of Cediranib by AZ, the trial was discontinued early so that only 38 patients (19 per arm) were recruited. One patient in the Cediranib arm did not complete their patient diary, and it was not known how much of the trial treatment they had. Therefore the adverse events reported by the patient could not be attributed to the trial treatment and they were excluded from all analyses."
276698|NCT01310803|B3|Baseline|Total|Total of all reporting groups
276699|NCT01310803|B2|Baseline|No Maintenance (Standard of Care)|"Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy~No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy"
276700|NCT01310803|B1|Baseline|Maintenance Therapy|"Chemotherapeutic: EN3329-301 (VALSTAR)~VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase"
276701|NCT01310803|P2|Participant Flow|No Maintenance (Standard of Care)|"Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy~No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy"
276702|NCT01310803|P1|Participant Flow|Maintenance Therapy|"Chemotherapeutic: EN3329-301 (VALSTAR)~VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase"
276703|NCT01310803|O2|Outcome|No Maintenance (Standard of Care)|"Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy~No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy"
276704|NCT01310803|O1|Outcome|Maintenance Therapy|"Chemotherapeutic: EN3329-301 (VALSTAR)~VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase"
276705|NCT01310803|O2|Outcome|No Maintenance (Standard of Care)|"Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy~No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy"
314120|NCT01211145|O1|Outcome|Placebo|Placebo to ZOMIG nasal spray
276706|NCT01310803|O1|Outcome|Maintenance Therapy|"Chemotherapeutic: EN3329-301 (VALSTAR)~VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase"
276707|NCT01310803|E2|Reported Event|No Maintenance (Standard of Care)|"Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy~No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy"
276708|NCT01310803|E1|Reported Event|Maintenance Therapy|"Chemotherapeutic: EN3329-301 (VALSTAR)~VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase"
276709|NCT01310777|B4|Baseline|Total|Total of all reporting groups
276710|NCT01310777|B3|Baseline|Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
276711|NCT01310777|B2|Baseline|Brinz|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
276712|NCT01310777|B1|Baseline|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
276713|NCT01310777|P3|Participant Flow|Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
276714|NCT01310777|P2|Participant Flow|Brinz|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
276715|NCT01310777|P1|Participant Flow|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
276716|NCT01310777|O3|Outcome|Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
276717|NCT01310777|O2|Outcome|Brinz|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
276718|NCT01310777|O1|Outcome|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
276719|NCT01310777|E3|Reported Event|Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
276720|NCT01310777|E2|Reported Event|Brinz|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
276721|NCT01310777|E1|Reported Event|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
276722|NCT01310699|B3|Baseline|Total|Total of all reporting groups
276723|NCT01310699|B2|Baseline|High Definition White Light Colonoscopy|"Use of high definition white light colonoscopy during examination for polyp detection.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
276724|NCT01310699|B1|Baseline|High Definition NBI Colonoscopy|"Use of high definition narrow band imaging colonoscopy during examination for polyp detection.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
276725|NCT01310699|P2|Participant Flow|High Definition White Light Colonoscopy|"Use of high definition white light colonoscopy during examination for polyp detection.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
276726|NCT01310699|P1|Participant Flow|High Definition NBI Colonoscopy|"Use of high definition narrow band imaging colonoscopy during examination for polyp detection.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
276727|NCT01310699|O2|Outcome|High Definition White Light Colonoscopy|"Use of high definition white light colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
276728|NCT01310699|O1|Outcome|High Definition NBI Colonoscopy|"Use of high definition narrow band imaging colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
276729|NCT01310699|O2|Outcome|High Definition White Light Colonoscopy|"Use of high definition white light colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
276730|NCT01310699|O1|Outcome|High Definition NBI Colonoscopy|"Use of high definition narrow band imaging colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
276731|NCT01310699|O2|Outcome|High Definition White Light Colonoscopy|"Use of high definition white light colonoscopy during examination for polyp detection.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
276732|NCT01310699|O1|Outcome|High Definition NBI Colonoscopy|"Use of high definition narrow band imaging colonoscopy during examination for polyp detection.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
276733|NCT01310699|E2|Reported Event|High Definition White Light Colonoscopy|"Use of high definition white light colonoscopy during examination for polyp detection.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
276734|NCT01310699|E1|Reported Event|High Definition NBI Colonoscopy|"Use of high definition narrow band imaging colonoscopy during examination for polyp detection.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
276735|NCT01310582|B3|Baseline|Total|Total of all reporting groups
276736|NCT01310582|B2|Baseline|Sevoflurane|During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
314121|NCT01211145|O4|Outcome|ZOMIG 5 mg|ZOMIG nasal spray
276737|NCT01310582|B1|Baseline|Desflurane|During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
276738|NCT01310582|P2|Participant Flow|Sevoflurane|During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
276739|NCT01310582|P1|Participant Flow|Desflurane|During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
276740|NCT01310582|O2|Outcome|Sevoflurane|During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
276741|NCT01310582|O1|Outcome|Desflurane|During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
276742|NCT01310582|O2|Outcome|Sevoflurane|During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
276743|NCT01310582|O1|Outcome|Desflurane|During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
276744|NCT01310582|E2|Reported Event|Sevoflurane|During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
276745|NCT01310582|E1|Reported Event|Desflurane|During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
276746|NCT01310413|B7|Baseline|Total|Total of all reporting groups
276747|NCT01310413|B6|Baseline|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276748|NCT01310413|B5|Baseline|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276749|NCT01310413|B4|Baseline|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276750|NCT01310413|B3|Baseline|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276751|NCT01310413|B2|Baseline|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276752|NCT01310413|B1|Baseline|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276753|NCT01310413|P7|Participant Flow|Placebo/Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
276930|NCT01310400|E3|Reported Event|Agrippal 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
277024|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
276754|NCT01310413|P6|Participant Flow|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276755|NCT01310413|P5|Participant Flow|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276756|NCT01310413|P4|Participant Flow|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276757|NCT01310413|P3|Participant Flow|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276758|NCT01310413|P2|Participant Flow|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276759|NCT01310413|P1|Participant Flow|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276760|NCT01310413|O1|Outcome|Placebo/Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 of was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
276761|NCT01310413|O1|Outcome|Placebo/Influenza A (H5N1) Virus Monovalent Vaccine Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
276762|NCT01310413|O1|Outcome|Placebo/Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 of was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
276763|NCT01310413|O1|Outcome|Placebo/Influenza A (H5N1) Virus Monovalent Vaccine Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
276861|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276764|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276765|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276766|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276767|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276768|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276769|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and PInfluenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276770|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276771|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, PInfluenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276772|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
277025|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
276773|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276774|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276775|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276776|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276777|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276778|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&amp;lt;12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&amp;gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276779|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276780|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276789|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
277026|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
276781|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276782|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&amp;lt;12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&amp;gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276783|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276784|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276785|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276786|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276787|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276788|NCT01310413|O1|Outcome|Placebo/ Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 of was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
276807|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276917|NCT01310400|P1|Participant Flow|Inflexal V 0.5 mL|Subjects received 2 doses: 1st dose on Day 0, 2nd dose on Day 28
314122|NCT01211145|O3|Outcome|ZOMIG 2.5 mg|ZOMIG nasal spray
276790|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276791|NCT01310413|O1|Outcome|Placebo/ Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
276792|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276793|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276794|NCT01310413|O1|Outcome|Placebo/ Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
276795|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276796|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276797|NCT01310413|O1|Outcome|Placebo/Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
276860|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
314123|NCT01211145|O2|Outcome|ZOMIG 0.5 mg|ZOMIG nasal spray
276798|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276799|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276800|NCT01310413|O1|Outcome|Placebo/ Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
276801|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276802|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, PInfluenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276803|NCT01310413|O1|Outcome|Placebo/Placebo/ Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
276804|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276805|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276806|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276918|NCT01310400|O3|Outcome|Agrippal 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
276919|NCT01310400|O2|Outcome|Inflexal V 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
276808|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276809|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276810|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276811|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276812|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276813|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276814|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276815|NCT01310413|O3|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276816|NCT01310413|O2|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276817|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276818|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276819|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276820|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276920|NCT01310400|O1|Outcome|Inflexal V 0.5 mL|The safety data are shown for the safety population (N = 452 for this group).
277027|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
276821|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276822|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276823|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276824|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276825|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276826|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276827|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276828|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276829|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276830|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276831|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276832|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276833|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276921|NCT01310400|O3|Outcome|Agrippal 0.25 mL|The immunogenicity results are shown for the per-protocol population (N = 384 for this group).
276922|NCT01310400|O2|Outcome|Inflexal V 0.25 mL|The immunogenicity results are shown for the per-protocol population (N = 380 for this group).
276834|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276835|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276836|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276837|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276838|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276839|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276840|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276841|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276842|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276843|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276844|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276845|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276846|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276923|NCT01310400|O1|Outcome|Inflexal V 0.5 mL|The immunogenicity results are shown for the per-protocol population (N = 423 for this group).
276924|NCT01310400|O3|Outcome|Agrippal 0.25 mL|The immunogenicity results are shown for the per-protocol population (N = 384 for this group).
276847|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276848|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276849|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276850|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276851|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276852|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276853|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276854|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276855|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276856|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276857|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276858|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|SSubjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276859|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276931|NCT01310400|E2|Reported Event|Inflexal V 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
276862|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276863|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276864|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276865|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276866|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276867|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276868|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276869|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276870|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276871|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276872|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276873|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276874|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276925|NCT01310400|O2|Outcome|Inflexal V 0.25 mL|The immunogenicity results are shown for the per-protocol population (N = 380 for this group).
276932|NCT01310400|E1|Reported Event|Inflexal V 0.5 mL|The safety data are shown for the safety population (N = 452 for this group).
276875|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276876|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276877|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276878|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276879|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276880|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276881|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276882|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276883|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276884|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276885|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276886|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276887|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276926|NCT01310400|O1|Outcome|Inflexal V 0.5 mL|The immunogenicity results are shown for the per-protocol population (N = 423 for this group).
276927|NCT01310400|O3|Outcome|Agrippal 0.25 mL|The immunogenicity results are shown for the per-protocol population (N = 384 for this group).
276888|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276889|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276890|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276891|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276892|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276893|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276894|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276895|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276896|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276897|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276898|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276899|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276900|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276928|NCT01310400|O2|Outcome|Inflexal V 0.25 mL|The immunogenicity results are shown for the per-protocol population (N = 380 for this group).
276929|NCT01310400|O1|Outcome|Inflexal V 0.5 mL|The immunogenicity results are shown for the per-protocol population (N = 423 for this group).
276901|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276902|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276903|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276904|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276905|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276906|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276907|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276908|NCT01310413|E3|Reported Event|Placebo/Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6≤36M, Placebo 3≤9Y or Placebo 9≤18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6≤36M, Placebo 3≤9Y and Placebo 9≤18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
276909|NCT01310413|E2|Reported Event|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9≤18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (≥) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276910|NCT01310413|E1|Reported Event|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3≤9Y and Influenza A (H5N1) adjuvanted 9≤18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (≥12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
276911|NCT01310400|B4|Baseline|Total|Total of all reporting groups
276912|NCT01310400|B3|Baseline|Agrippal 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
276913|NCT01310400|B2|Baseline|Inflexal V 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
276914|NCT01310400|B1|Baseline|Inflexal V 0.5 mL|The safety data are shown for the safety population (N = 452 for this group).
276915|NCT01310400|P3|Participant Flow|Agrippal 0.25 mL|Subjects received 2 doses: 1st dose on Day 0, 2nd dose on Day 28
276916|NCT01310400|P2|Participant Flow|Inflexal V 0.25 mL|Subjects received 2 doses: 1st dose on Day 0, 2nd dose on Day 28
276933|NCT01310179|B1|Baseline|Ad/PNP and Fludarabine Monophosphate|"Ad/PNP will be injected three times into the tumor over 2 days followed by three daily intravenous infusions of F-araAMP (fludarabine monophosphate). Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days.~Ad/PNP and fludarabine monophosphate: Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days."
276934|NCT01310179|P1|Participant Flow|Ad/PNP and Fludarabine Monophosphate|"Ad/PNP will be injected three times into the tumor over 2 days followed by three daily intravenous infusions of F-araAMP (fludarabine monophosphate). Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days.~Ad/PNP and fludarabine monophosphate: Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days."
276935|NCT01310179|O1|Outcome|Ad/PNP and Fludarabine Monophosphate|"Ad/PNP will be injected three times into the tumor over 2 days followed by three daily intravenous infusions of F-araAMP (fludarabine monophosphate). Subjects in the first three cohorts will receive 3x10e11 VP for 3 injections and 5, 15 or 25 mg/m2 of F-araAMP daily for 3 days. Subject in the fourth cohort will receive 3x10e12 VP for 3 injections and the highest tolerated dose of F-araAMP daily for 3 days.~Ad/PNP and fludarabine monophosphate: Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days."
276936|NCT01310179|O1|Outcome|Ad/PNP and Fludarabine Monophosphate|"Ad/PNP will be injected three times into the tumor over 2 days followed by three daily intravenous infusions of F-araAMP (fludarabine monophosphate). Subjects in the first three cohorts will receive 3x10e11 VP for 3 injections and 5, 15 or 25 mg/m2 of F-araAMP daily for 3 days. Subject in the fourth cohort will receive 3x10e12 VP for 3 injections and the highest tolerated dose of F-araAMP daily for 3 days.~Ad/PNP and fludarabine monophosphate: Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days."
276937|NCT01310179|E1|Reported Event|Ad/PNP and Fludarabine Monophosphate|"Ad/PNP will be injected three times into the tumor over 2 days followed by three daily intravenous infusions of F-araAMP (fludarabine monophosphate). Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days..~Ad/PNP and fludarabine monophosphate: Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days."
276938|NCT01310127|B3|Baseline|Total|Total of all reporting groups
276939|NCT01310127|B2|Baseline|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
276940|NCT01310127|B1|Baseline|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
276941|NCT01310127|P2|Participant Flow|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
276942|NCT01310127|P1|Participant Flow|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
276943|NCT01310127|O2|Outcome|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
276944|NCT01310127|O1|Outcome|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
276945|NCT01310127|O2|Outcome|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
276946|NCT01310127|O1|Outcome|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
276947|NCT01310127|O2|Outcome|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
276948|NCT01310127|O1|Outcome|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
276949|NCT01310127|O2|Outcome|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
276950|NCT01310127|O1|Outcome|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
276951|NCT01310127|E2|Reported Event|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
276952|NCT01310127|E1|Reported Event|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
276953|NCT01309997|B3|Baseline|Total|Total of all reporting groups
276954|NCT01309997|B2|Baseline|Arm II (Monoclonal Antibody)|Patients receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle is repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity. TDuring the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to imatinib.
276987|NCT01309919|O2|Outcome|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all~Diary: Subjects will keep a bleeding diary for three months"
276955|NCT01309997|B1|Baseline|Arm I (Enzyme Inhibitor)|Patients receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity. During the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to rituximab.
276956|NCT01309997|P2|Participant Flow|Arm II (Monoclonal Antibody)|Patients receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle is repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity. During the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to imatinib.
276957|NCT01309997|P1|Participant Flow|Arm I (Enzyme Inhibitor)|Patients receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity. During the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to rituximab.
276958|NCT01309997|O4|Outcome|Imatinib Nonresponders|Did not attain a SCR with imatinib
276959|NCT01309997|O3|Outcome|Imatinib Responders|Attained a SCR with imatinib
276960|NCT01309997|O2|Outcome|Rituximab Non-responders|Did not attain a SCR with rituximab
276961|NCT01309997|O1|Outcome|Rituximab Responders|Attained a SCR with rituximab
276962|NCT01309997|O2|Outcome|Arm II (Monoclonal Antibody)|Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
276963|NCT01309997|O1|Outcome|Arm I (Enzyme Inhibitor)|Patients randomized to receive imatinib mesylate PO QD as their first therapy. They may take this from 1 mo-18 mo.
276964|NCT01309997|O2|Outcome|Arm II (Monoclonal Antibody)|Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
276965|NCT01309997|O1|Outcome|Arm 1 (Enzyme Inhibitor)|Patients randomized to receive imatinib mesylate PO QD as their first therapy. They may take this from 1 mo-18 mo.
276966|NCT01309997|O2|Outcome|Arm II (Monocolonal Antibody)|Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
276967|NCT01309997|O1|Outcome|Arm 1 (Enzyme Inhibitor)|Patients randomized to receive imatinib mesylate PO QD as their first therapy. They may take this from 1 mo-18 mo.
276968|NCT01309997|O2|Outcome|Arm II (Monoclonal Antibody)|Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
276969|NCT01309997|O1|Outcome|Arm I (Enzyme Inhibitor)|Patients randomized to receive imatinib mesylate PO QD as their first therapy. They may take this from 1 mo-18 mo.
276970|NCT01309997|O2|Outcome|Arm II (Monoclonal Antibody)|Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
276971|NCT01309997|O1|Outcome|Arm I (Enzyme Inhibitor)|Patients randomized to receive imatinib mesylate as their first therapy. They may take this from 1 mo-18 mo.
276972|NCT01309997|O2|Outcome|Arm II (Monoclonal Antibody)|Patients who were randomized to receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle was repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity.
276973|NCT01309997|O1|Outcome|Arm I (Enzyme Inhibitor)|Patients who were randomized to receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity.
276974|NCT01309997|E4|Reported Event|Rituximab as Secondary Therapy|Arm II = rituximab, adverse event occurred after the start date of rituximab. (All participants in this group received imatinib prior).
276975|NCT01309997|E3|Reported Event|Imatinib as Secondary Therapy|Arm II = imatinib, adverse event occurred after the start date of imatinib. (All participants in this group received rituximab prior).
276976|NCT01309997|E2|Reported Event|Rituximab as Initial Therapy|Arm I = rituximab, adverse event occurred after the start date of rituximab and if applicable, prior to start date of imatinib.
276977|NCT01309997|E1|Reported Event|Imatinib as Initial Therapy|Arm I = imatinib, adverse event occurred after the start date of imatinib and if applicable, prior to start date of rituximab.
276978|NCT01309919|B3|Baseline|Total|Total of all reporting groups
276979|NCT01309919|B2|Baseline|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all~Diary: Subjects will keep a bleeding diary for three months"
276980|NCT01309919|B1|Baseline|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)~IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.~Diary: Subjects will keep a bleeding diary for three months"
276981|NCT01309919|P2|Participant Flow|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all~Diary: Subjects will keep a bleeding diary for three months"
276982|NCT01309919|P1|Participant Flow|Intrauterine Device (IUD) Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)~IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.~Diary: Subjects will keep a bleeding diary for three months"
276983|NCT01309919|O2|Outcome|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all~Diary: Subjects will keep a bleeding diary for three months"
276984|NCT01309919|O1|Outcome|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)~IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.~Diary: Subjects will keep a bleeding diary for three months"
276985|NCT01309919|O2|Outcome|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all~Diary: Subjects will keep a bleeding diary for three months"
276986|NCT01309919|O1|Outcome|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)~IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.~Diary: Subjects will keep a bleeding diary for three months"
277023|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
276988|NCT01309919|O1|Outcome|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)~IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.~Diary: Subjects will keep a bleeding diary for three months"
276989|NCT01309919|O2|Outcome|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all~Diary: Subjects will keep a bleeding diary for three months"
276990|NCT01309919|O1|Outcome|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)~IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.~Diary: Subjects will keep a bleeding diary for three months"
276991|NCT01309919|E2|Reported Event|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all~Diary: Subjects will keep a bleeding diary for three months"
276992|NCT01309919|E1|Reported Event|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)~IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.~Diary: Subjects will keep a bleeding diary for three months"
276993|NCT01309893|B1|Baseline|Entire Study Population|All eligible enrolled participants
276994|NCT01309893|P2|Participant Flow|Air Optix Aqua Lens First, Then Investigational Lens|Enrolled participants spent 1 week using Air Optix Aqua Lens, and then crossed over to 1 week using Investigational Lens. The order of contact lens use was randomized and participant-masked.
276995|NCT01309893|P1|Participant Flow|Investigational Lens First, Then Air Optix Aqua Lens|Enrolled participants spent 1 week using Investigational Lens, and then crossed over to 1 week using Air Optix Aqua lens. The order of contact lens use was randomized and participant-masked.
276996|NCT01309893|O2|Outcome|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens~Air Optix Aqua lens: Lenses worn on a daily wear basis for one week"
276997|NCT01309893|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel contact lens~Investigational Lens: Lenses worn on a daily wear basis for one week"
276998|NCT01309893|O2|Outcome|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens~Air Optix Aqua lens: Lenses worn on a daily wear basis for one week"
276999|NCT01309893|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel contact lens~Investigational Lens: Lenses worn on a daily wear basis for one week"
277000|NCT01309893|O2|Outcome|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens~Air Optix Aqua lens: Lenses worn on a daily wear basis for one week"
277001|NCT01309893|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel contact lens~Investigational Lens: Lenses worn on a daily wear basis for one week"
277002|NCT01309893|E2|Reported Event|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens~Air Optix Aqua lens: Lenses worn on a daily wear basis for one week"
277003|NCT01309893|E1|Reported Event|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel contact lens~Investigational Lens: Lenses worn on a daily wear basis for one week"
277004|NCT01309880|B1|Baseline|Overall Study|One-half of the participants (33) were randomized to receive the investigational RD2117-01 ID4 contact lens, and the other half (33) was randomized to receive the Air Optix Aqua contact lens. Both groups wore the lenses on a daily wear basis. After one week of wearing the first lens type, the subjects returned for an exam and crossed over to the second lens type for one week.
277005|NCT01309880|P2|Participant Flow|Test Lens Then Air Optix Aqua|The test lens was an Investigational silicone hydrogel contact lens. Lenses were worn on a daily wear basis. After one week participants crossed over to Ciba Vision Air Optix Aqua contact lens.. All subjects were provided with Bausch + Lomb renu® fresh™ multi-purpose solution and lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses, and Bausch + Lomb Sensitive Eyes® Rewetting Drops for use as needed during the study.
277006|NCT01309880|P1|Participant Flow|Air Optix Aqua Then Test Lens|Ciba Vision Air Optix Aqua contact lens. Lenses were worn on a daily wear basis. After one week participants crossed over to the Test lens. All subjects were provided with Bausch + Lomb renu® fresh™ multi-purpose solution and lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses, and Bausch + Lomb Sensitive Eyes® Rewetting Drops for use as needed during the study.
277007|NCT01309880|O2|Outcome|Test Lens|"Investigational silicone hydrogel contact lens~Test lens: Investigational silicone hydrogel contact lens worn on a daily wear basis"
277008|NCT01309880|O1|Outcome|Air Optix Aqua|"Ciba Vision daily wear contact lens~Air Optix Aqua: Air Optix Aqua contact lens worn on a daily wear basis"
277009|NCT01309880|O2|Outcome|Test Lens|"Investigational silicone hydrogel contact lens~Test lens: Investigational silicone hydrogel contact lens worn on a daily wear basis"
277010|NCT01309880|O1|Outcome|Air Optix Aqua|"Ciba Vision daily wear contact lens~Air Optix Aqua: Air Optix Aqua contact lens worn on a daily wear basis"
277011|NCT01309880|O2|Outcome|Test Lens|"Investigational silicone hydrogel contact lens~Test lens: Investigational silicone hydrogel contact lens worn on a daily wear basis"
277012|NCT01309880|O1|Outcome|Air Optix Aqua|"Ciba Vision daily wear contact lens~Air Optix Aqua: Air Optix Aqua contact lens worn on a daily wear basis"
277013|NCT01309880|E2|Reported Event|Test Lens|"Investigational silicone hydrogel contact lens~Test lens: Investigational silicone hydrogel contact lens worn on a daily wear basis"
277014|NCT01309880|E1|Reported Event|Air Optix Aqua|"Ciba Vision daily wear contact lens~Air Optix Aqua: Air Optix Aqua contact lens worn on a daily wear basis"
277015|NCT01309841|B4|Baseline|Total|Total of all reporting groups
277016|NCT01309841|B3|Baseline|Placebo|Placebo QD, oral treatment
277017|NCT01309841|B2|Baseline|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
277018|NCT01309841|B1|Baseline|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
277019|NCT01309841|P3|Participant Flow|Placebo|Placebo QD, oral treatment
277020|NCT01309841|P2|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
277021|NCT01309841|P1|Participant Flow|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
277022|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
277029|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
277030|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
277031|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
277032|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
277033|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
277034|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
277035|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
277036|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
277037|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
277038|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
277039|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
277040|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
277041|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
277042|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
277043|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
277044|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
277045|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
277046|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
277047|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
277048|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
277049|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
277050|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
277051|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
277052|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
277053|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
277054|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
277055|NCT01309841|E3|Reported Event|Placebo|
277056|NCT01309841|E2|Reported Event|NKTR-118 25 mg|
277057|NCT01309841|E1|Reported Event|NKTR-118 12.5 mg|
277058|NCT01309828|B3|Baseline|Total|Total of all reporting groups
277059|NCT01309828|B2|Baseline|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
277060|NCT01309828|B1|Baseline|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
277061|NCT01309828|P2|Participant Flow|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
277062|NCT01309828|P1|Participant Flow|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
277063|NCT01309828|O2|Outcome|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
277064|NCT01309828|O1|Outcome|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
277065|NCT01309828|O2|Outcome|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
277066|NCT01309828|O1|Outcome|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
277067|NCT01309828|O2|Outcome|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
277068|NCT01309828|O1|Outcome|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
277069|NCT01309828|O2|Outcome|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
277141|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277070|NCT01309828|O1|Outcome|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
277071|NCT01309828|E2|Reported Event|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
277072|NCT01309828|E1|Reported Event|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
277073|NCT01309802|B3|Baseline|Total|Total of all reporting groups
277074|NCT01309802|B2|Baseline|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1~onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
277075|NCT01309802|B1|Baseline|Placebo|no intervention
277076|NCT01309802|P2|Participant Flow|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1~onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
277077|NCT01309802|P1|Participant Flow|Placebo|no intervention
277078|NCT01309802|O2|Outcome|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1~onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
277079|NCT01309802|O1|Outcome|Placebo|no intervention
277080|NCT01309802|O2|Outcome|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1~onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
277081|NCT01309802|O1|Outcome|Placebo|no intervention
277082|NCT01309802|O2|Outcome|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1~onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
277083|NCT01309802|O1|Outcome|Placebo|no intervention
277084|NCT01309802|O2|Outcome|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1~onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
277085|NCT01309802|O1|Outcome|Placebo|no intervention
277086|NCT01309802|O2|Outcome|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1~onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
277087|NCT01309802|O1|Outcome|Placebo|no intervention
277088|NCT01309802|O2|Outcome|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1~onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
277089|NCT01309802|O1|Outcome|Placebo|no intervention
277090|NCT01309802|E2|Reported Event|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1~onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
277091|NCT01309802|E1|Reported Event|Placebo|no intervention
277092|NCT01309737|B4|Baseline|Total|Total of all reporting groups
277093|NCT01309737|B3|Baseline|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
277094|NCT01309737|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277095|NCT01309737|B1|Baseline|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277096|NCT01309737|P5|Participant Flow|Placebo,CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277097|NCT01309737|P4|Participant Flow|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and there after received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277098|NCT01309737|P3|Participant Flow|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
277099|NCT01309737|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277100|NCT01309737|P1|Participant Flow|CP-690,550 5mg|CP-690,550 (tofacitinib) 5 milligram (mg) tablet orally twice daily up to Week 52.
277101|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277102|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277103|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277104|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277105|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
277106|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277107|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277108|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
277109|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277110|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277111|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
277112|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277113|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277114|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
277115|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277116|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277117|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
277118|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277119|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277120|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
277121|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277122|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277123|NCT01309737|O4|Outcome|Placebo, Then CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277124|NCT01309737|O3|Outcome|Placebo, Then CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277125|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277126|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277127|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277128|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277129|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277130|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277131|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277132|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277133|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277134|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277135|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277136|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277137|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277138|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277139|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277140|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277142|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277143|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277144|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277145|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277146|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277147|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277148|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277149|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277150|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277151|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277152|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277153|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277154|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277155|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277156|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277157|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277158|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277159|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277160|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277161|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277162|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277163|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277164|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277165|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277166|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277167|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277168|NCT01309737|O3|Outcome|Placebo, Then CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277169|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277170|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277171|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277172|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277173|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277174|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277175|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277176|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277177|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277178|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277179|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277180|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277181|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277182|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277183|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277184|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
314124|NCT01211145|O1|Outcome|Placebo|Placebo to ZOMIG nasal spray
277185|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277186|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277187|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277188|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277189|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277190|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277191|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277192|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277193|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277194|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277195|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277196|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277197|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277198|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277199|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277200|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277201|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277202|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277203|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277204|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277205|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277206|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277207|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277208|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277209|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277210|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277211|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and there after received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277212|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277213|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277214|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277215|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277216|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277217|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277218|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277219|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277220|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277221|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277222|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277223|NCT01309737|O4|Outcome|Placebo, Then CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277224|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277225|NCT01309737|O2|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277226|NCT01309737|O1|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277227|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277451|NCT01309360|O3|Outcome|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
277228|NCT01309737|O3|Outcome|Placebo,CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277229|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277230|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277231|NCT01309737|O4|Outcome|Placebo, Then CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and there after received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277232|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277233|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277234|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277235|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277236|NCT01309737|O3|Outcome|Placebo,CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277237|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277238|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277239|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277240|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277241|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277242|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277243|NCT01309737|O4|Outcome|Placebo, Then CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277244|NCT01309737|O3|Outcome|Placebo, Then CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277245|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277246|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277247|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
277248|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277249|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277250|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
277251|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277252|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277253|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
277254|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277255|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277256|NCT01309737|O2|Outcome|CP-690,550 10 mg|Participants who received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277257|NCT01309737|O1|Outcome|CP-690,550 5mg|Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277258|NCT01309737|O2|Outcome|CP-690,550 10 mg|Participants who received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277259|NCT01309737|O1|Outcome|CP-690,550 5mg|Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277260|NCT01309737|O2|Outcome|CP-690,550 10 mg|Participants who received CP-690,550 10 mg tablet orally twice daily up to Week 52.
277261|NCT01309737|O1|Outcome|CP-690,550 5mg|Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52.
277262|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
277263|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277264|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277265|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
277266|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277267|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277268|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
277269|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277270|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277271|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
277272|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277273|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
314125|NCT01211145|O4|Outcome|ZOMIG 5 mg|ZOMIG nasal spray
277274|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
277275|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277276|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277277|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
277278|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277279|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277280|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
277281|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277282|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277283|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
277284|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277285|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277286|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
277287|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277288|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
277289|NCT01309737|E5|Reported Event|Placebo|Participants who received placebo matched to CP-690,550 tablet orally twice daily up to Week 16 but were not re-randomized to CP-690,550 treatment.
277290|NCT01309737|E4|Reported Event|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16 and thereafter CP-690,550 10 mg tablet orally twice daily up to Week 52.
277291|NCT01309737|E3|Reported Event|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16 and thereafter CP-690,550 5 mg tablet orally twice daily up to Week 52.
277292|NCT01309737|E2|Reported Event|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
277293|NCT01309737|E1|Reported Event|CP-690,550 5mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Week 52.
277294|NCT01309672|B1|Baseline|Abiraterone Acetate + Prednisone|"Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily~Prednisone, 5 mg, oral, 5 mg twice daily~abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily~Prednisone: 5 mg, oral, 5 mg twice daily"
277295|NCT01309672|P1|Participant Flow|Abiraterone Acetate + Prednisone|"Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily~Prednisone, 5 mg, oral, 5 mg twice daily~abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily~Prednisone: 5 mg, oral, 5 mg twice daily"
277296|NCT01309672|O1|Outcome|Abiraterone Acetate + Prednisone|Abiraterone: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone: 5 mg, oral, 5 mg twice daily
277297|NCT01309672|O1|Outcome|Abiraterone Acetate + Prednisone|"Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily~Prednisone, 5 mg, oral, 5 mg twice daily~abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily~Prednisone: 5 mg, oral, 5 mg twice daily"
277298|NCT01309672|O1|Outcome|Abiraterone Acetate + Prednisone|"Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily~Prednisone, 5 mg, oral, 5 mg twice daily~abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily~Prednisone: 5 mg, oral, 5 mg twice daily"
277299|NCT01309672|O1|Outcome|Abiraterone Acetate + Prednisone|"Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily~Prednisone, 5 mg, oral, 5 mg twice daily~abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily~Prednisone: 5 mg, oral, 5 mg twice daily"
277300|NCT01309672|O1|Outcome|Abiraterone Acetate + Prednisone|"Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily~Prednisone, 5 mg, oral, 5 mg twice daily~abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily~Prednisone: 5 mg, oral, 5 mg twice daily"
277301|NCT01309672|E1|Reported Event|Abiraterone Acetate + Prednisone|Abiraterone: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone: 5 mg, oral, 5 mg twice daily
277302|NCT01309659|B3|Baseline|Total|Total of all reporting groups
277303|NCT01309659|B2|Baseline|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277304|NCT01309659|B1|Baseline|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277404|NCT01309451|O2|Outcome|Combined Group|"Bevacizumab plus Ozurdex~Bevacizumab: intravitreal, 1.25mg., monthly~dexamethasone intravitreal implant: 0.7mg, intravitreal every 4 months"
277405|NCT01309451|O1|Outcome|Bevacizumab Alone|Bevacizumab: intravitreal, 1.25mg., monthly
278122|NCT01307020|O5|Outcome|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
277305|NCT01309659|P2|Participant Flow|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277306|NCT01309659|P1|Participant Flow|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277307|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277308|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277309|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277310|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277311|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277312|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277313|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277314|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277315|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277316|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277317|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277318|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277319|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277320|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
278313|NCT01306253|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
277321|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277322|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277323|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277324|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277325|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277326|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277327|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277328|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277329|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277330|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277331|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277332|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277333|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277334|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277335|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277336|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277452|NCT01309360|O2|Outcome|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
277337|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277338|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277339|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277340|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277341|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277342|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277343|NCT01309659|E2|Reported Event|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277344|NCT01309659|E1|Reported Event|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
277345|NCT01309646|B3|Baseline|Total|Total of all reporting groups
277346|NCT01309646|B2|Baseline|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277347|NCT01309646|B1|Baseline|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277348|NCT01309646|P2|Participant Flow|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277349|NCT01309646|P1|Participant Flow|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277350|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277351|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277406|NCT01309451|E2|Reported Event|Combined Group|bevacizumab 1.25mg intravitreally plus Ozurdex THIS GROUP ALSO INCLUDES PARTICIPANTS WHO HAD BOTH EYES IN THE STUDY (they received bevacizumab alone in one eye and bavacizumab + Ozurdex in the other.
277407|NCT01309451|E1|Reported Event|Bevacizumab Alone Group|bevacizumab 1.25mg intravitreally
277352|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277353|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277354|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277355|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277356|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277357|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277358|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277359|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277360|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277361|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277362|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277363|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277364|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277408|NCT01309386|B3|Baseline|Total|Total of all reporting groups
277409|NCT01309386|B2|Baseline|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
277365|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277366|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277367|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277368|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277369|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277370|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277371|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277372|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277373|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277374|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277375|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277376|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277377|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277410|NCT01309386|B1|Baseline|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
278314|NCT01306253|E2|Reported Event|Elderly|Elderly subjects aged over 60 years
277378|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277379|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277380|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277381|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277382|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277383|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277384|NCT01309646|E2|Reported Event|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277385|NCT01309646|E1|Reported Event|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
277386|NCT01309581|B3|Baseline|Total|Total of all reporting groups
277387|NCT01309581|B2|Baseline|Methohexital|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
277388|NCT01309581|B1|Baseline|Ketamine|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
277389|NCT01309581|P2|Participant Flow|Methohexital|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
277390|NCT01309581|P1|Participant Flow|Ketamine|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
277391|NCT01309581|O2|Outcome|Methohexital|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
277392|NCT01309581|O1|Outcome|Ketamine|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
277393|NCT01309581|O2|Outcome|Methohexital|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
277394|NCT01309581|O1|Outcome|Ketamine|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
277395|NCT01309581|E2|Reported Event|Methohexitol|
277396|NCT01309581|E1|Reported Event|Ketamine|
277397|NCT01309451|B3|Baseline|Total|Total of all reporting groups
277398|NCT01309451|B2|Baseline|Combine Group|Bevacizumab plus Ozurdex
277399|NCT01309451|B1|Baseline|Bevacizumab Alone|Bevacizumab only
277400|NCT01309451|P2|Participant Flow|Combined Group|bevacizumab plus Ozurdex group received bevacizumab at baseline followed by Ozurdex at the one month visit. Retreatment with bevaciumab given at monthly intervals when retreatment criteria met except for months 5 and 10 when retreatment with Ozurdex was given.
277401|NCT01309451|P1|Participant Flow|Bevacizumab Alone|monthly injection of bevacizumab intravitreally when retreatment criteria met
277402|NCT01309451|O2|Outcome|Combined Group|bevacizumab plus Ozurdex group received bevacizumab at baseline followed by Ozurdex at the one month visit. Retreatment with bevaciumab given at monthly intervals when retreatment criteria met except for months 5 and 10 when retreatment with Ozurdex was given.
277403|NCT01309451|O1|Outcome|Bevacizumab Alone|monthly injection of bevacizumab intravitreally when retreatment criteria met
277411|NCT01309386|P2|Participant Flow|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
277412|NCT01309386|P1|Participant Flow|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
277413|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
277414|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
277415|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
277416|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
277417|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
277418|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
277419|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
277420|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
277421|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
277422|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
277423|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
277424|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
277425|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
277426|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
277427|NCT01309386|E2|Reported Event|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
277428|NCT01309386|E1|Reported Event|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
277429|NCT01309360|B4|Baseline|Total|Total of all reporting groups
277430|NCT01309360|B3|Baseline|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
277431|NCT01309360|B2|Baseline|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
277432|NCT01309360|B1|Baseline|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml Prilocaine 1% were administered for axillary plexus block
277433|NCT01309360|P3|Participant Flow|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
277434|NCT01309360|P2|Participant Flow|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
277435|NCT01309360|P1|Participant Flow|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml Prilocaine 1% were administered for axillary plexus block
277436|NCT01309360|O3|Outcome|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
277437|NCT01309360|O2|Outcome|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
277438|NCT01309360|O1|Outcome|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
277439|NCT01309360|O3|Outcome|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
277440|NCT01309360|O2|Outcome|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
277441|NCT01309360|O1|Outcome|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
277442|NCT01309360|O3|Outcome|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
277443|NCT01309360|O2|Outcome|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
277444|NCT01309360|O1|Outcome|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
277445|NCT01309360|O3|Outcome|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
277446|NCT01309360|O2|Outcome|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
277447|NCT01309360|O1|Outcome|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
277448|NCT01309360|O3|Outcome|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
277449|NCT01309360|O2|Outcome|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
277450|NCT01309360|O1|Outcome|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
278315|NCT01306253|E1|Reported Event|Adults|Adults from 18 to 60 years old inclusive
277453|NCT01309360|O1|Outcome|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
277454|NCT01309360|E3|Reported Event|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
277455|NCT01309360|E2|Reported Event|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
277456|NCT01309360|E1|Reported Event|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml Prilocaine 1% were administered for axillary plexus block
277457|NCT01309308|B3|Baseline|Total|Total of all reporting groups
277458|NCT01309308|B2|Baseline|No Sweeping Group|The patients who did not have sweeping of the membranes
277459|NCT01309308|B1|Baseline|The Membranes Swept Group|The patient whose amniotic membranes are detached by the circular movements of the examining fingers
277460|NCT01309308|P2|Participant Flow|No Sweeping Group|The patients who did not have sweeping of the membranes
277461|NCT01309308|P1|Participant Flow|The Membranes Swept Group|The patient whose amniotic membranes are detached by the circular movements of the examining fingers
277462|NCT01309308|O2|Outcome|Not Swept|Patients whose membranes are not swept
277463|NCT01309308|O1|Outcome|Sweeping|In women who had completed 38 weeks of gestation sweeping was performed by separating the lower membranes as much as possible from their cervical attachment, with three circumferential passes of the examining fingers for only once.
277464|NCT01309308|O2|Outcome|Not Swept|Patients whose membranes are not swept
277465|NCT01309308|O1|Outcome|Sweeping|In women who had completed 38 weeks of gestation sweeping was performed by separating the lower membranes as much as possible from their cervical attachment, with three circumferential passes of the examining fingers for only once.
277466|NCT01309308|E2|Reported Event|No Sweeping Group|The patients who did not have sweeping of the membranes
277467|NCT01309308|E1|Reported Event|The Membranes Swept Group|The patient whose amniotic membranes are detached by the circular movements of the examining fingers
277468|NCT01309282|B1|Baseline|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
277469|NCT01309282|P1|Participant Flow|Rituximab|Participants with sero-positive [Rheumatoid Factor (RF) and/or anti-Cyclic Citrullinated Peptide (CCP+)] rheumatoid arthritis (RA), who had commenced therapy with rituximab (MabThera) following lack of response or intolerance to a single tumor necrosis factor (TNF)-inhibitor were included in this arm.
277470|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
277471|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
277472|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
277473|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
277474|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
277475|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
277476|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
277477|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
277478|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
277479|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
277480|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
277481|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
277482|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
277483|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
277484|NCT01309282|E1|Reported Event|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
277485|NCT01309269|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
277486|NCT01309269|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
277631|NCT01308749|O2|Outcome|Sequence 2: Placebo :Oxytocin|8 weeks double blind placebo followed by 8 wks open label oxytocin
277487|NCT01309269|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
277488|NCT01309269|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
277489|NCT01309269|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
277490|NCT01309269|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
277491|NCT01309243|B3|Baseline|Total|Total of all reporting groups
277492|NCT01309243|B2|Baseline|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
277493|NCT01309243|B1|Baseline|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
277494|NCT01309243|P2|Participant Flow|EFV/FTC/TDF|Efavirenz (EFV) 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
277495|NCT01309243|P1|Participant Flow|FTC/RPV/TDF|Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen (STR) administered orally once daily
277496|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
277497|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
277498|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
277499|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
277500|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
277501|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
277502|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
277503|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
277504|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
277505|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
277506|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
277507|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
277508|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
277509|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
277510|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
277511|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
277512|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
277513|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
277514|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
277515|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
277516|NCT01309243|E2|Reported Event|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
277517|NCT01309243|E1|Reported Event|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
277518|NCT01309204|B3|Baseline|Total|Total of all reporting groups
277519|NCT01309204|B2|Baseline|Brinz+Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
277520|NCT01309204|B1|Baseline|Brinz/Brim|Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
277521|NCT01309204|P2|Participant Flow|Brinz+Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
277522|NCT01309204|P1|Participant Flow|Brinz/Brim|Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
277523|NCT01309204|O2|Outcome|Brinz+Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
277524|NCT01309204|O1|Outcome|Brinz/Brim|Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
277525|NCT01309204|E2|Reported Event|Brinz+Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
277526|NCT01309204|E1|Reported Event|Brinz/Brim|Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
277527|NCT01309100|B1|Baseline|Overall Study|Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week.
277528|NCT01309100|P1|Participant Flow|Overall Study|Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week.
277529|NCT01309100|O2|Outcome|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens.~Air Optix Aqua Lens: Ciba Vision Air Optix Aqua contact lens on a daily wear basis for 1 week."
277530|NCT01309100|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel lens(RD2117-01).~Investigational Lens: Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week."
277531|NCT01309100|O2|Outcome|Acuvue Oasys Lens|"Johnson & Johnson Acuvue Oasys contact lens.~Acuvue Oasys Lens: Johnson & Johnson Acuvue Oasys contact lens on a daily wear basis for 1 week."
277532|NCT01309100|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel lens(RD2117-01).~Investigational Lens: Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week."
277533|NCT01309100|O2|Outcome|Acuvue Oasys Lens|"Johnson & Johnson Acuvue Oasys contact lens.~Acuvue Oasys Lens: Johnson & Johnson Acuvue Oasys contact lens on a daily wear basis for 1 week."
277534|NCT01309100|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel lens(RD2117-01).~Investigational Lens: Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week."
277535|NCT01309100|O2|Outcome|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens.~Air Optix Aqua Lens: Ciba Vision Air Optix Aqua contact lens on a daily wear basis for 1 week."
277536|NCT01309100|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel lens (RD2117-01).~Investigational Lens: Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week."
277537|NCT01309100|E1|Reported Event|Overall Study|Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week.
277538|NCT01308918|B1|Baseline|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
277539|NCT01308918|P1|Participant Flow|GlideScope DLT Intubation With GlideRite DLT Stylet|The double lumen tube (DLT) is the technique of choice to obtain lung isolation. The GlideScope® (GLS, video laryngoscope allowing vizualisation of the airway and tube placement, has been used with a high level of success to assist positioning a single lumen tube (SLT) in normal situations and mainly in situations where the airway is considered or proven to be difficult.We have designed a new semi-rigid intubating stylet, the GlideRite DLT Stylet® (GR-DLT-S), which can be used for primary DLT intubation with the GLS. This pilot study was planned to observe the efficiency and the safety of the GR-DLT-S for primary insertion of DLT with the GLS in patients presenting a normal superior airway. After obtaining local IRB approval, 50 patients scheduled for thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy at l’Institut de cardiologie et de pneumologie de Québec, were enrolled in this observational study.
277540|NCT01308918|O1|Outcome|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
277541|NCT01308918|O1|Outcome|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
277542|NCT01308918|O1|Outcome|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
277543|NCT01308918|O1|Outcome|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
277544|NCT01308918|E1|Reported Event|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
277545|NCT01308840|B1|Baseline|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)~Panitumumab: Day 1 and 15 = 6 mg/kg IV~oxaliplatin: Days 1 and 15 = 85mg/m2 IV~gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
277546|NCT01308840|P1|Participant Flow|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)~Panitumumab: Day 1 and 15 = 6 mg/kg IV~oxaliplatin: Days 1 and 15 = 85mg/m2 IV~gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
277547|NCT01308840|O1|Outcome|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)~Panitumumab: Day 1 and 15 = 6 mg/kg IV~oxaliplatin: Days 1 and 15 = 85mg/m2 IV~gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
277548|NCT01308840|O1|Outcome|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)~Panitumumab: Day 1 and 15 = 6 mg/kg IV~oxaliplatin: Days 1 and 15 = 85mg/m2 IV~gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
277632|NCT01308749|O1|Outcome|Sequence 1: Oxytocin-oxytocin|8 weeks of Intervention following randomization
278316|NCT01306214|B4|Baseline|Total|Total of all reporting groups
277549|NCT01308840|O1|Outcome|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)~Panitumumab: Day 1 and 15 = 6 mg/kg IV~oxaliplatin: Days 1 and 15 = 85mg/m2 IV~gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
277550|NCT01308840|O1|Outcome|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)~Panitumumab: Day 1 and 15 = 6 mg/kg IV~oxaliplatin: Days 1 and 15 = 85mg/m2 IV~gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
277551|NCT01308840|E1|Reported Event|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)~Panitumumab: Day 1 and 15 = 6 mg/kg IV~oxaliplatin: Days 1 and 15 = 85mg/m2 IV~gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
277552|NCT01308814|B3|Baseline|Total|Total of all reporting groups
277553|NCT01308814|B2|Baseline|Estradiol|"Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.~Estradiol: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered."
277554|NCT01308814|B1|Baseline|Placebo|"Placebo patches for 12 months and placebo pills for 12 days every 2 months.~Placebo: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months."
277555|NCT01308814|P2|Participant Flow|Estradiol|"Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.~Estradiol: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered."
277556|NCT01308814|P1|Participant Flow|Placebo|"Placebo patches for 12 months and placebo pills for 12 days every 2 months.~Placebo: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months."
277557|NCT01308814|O2|Outcome|Estradiol|"Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.~Estradiol: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered."
277558|NCT01308814|O1|Outcome|Placebo|"Placebo patches for 12 months and placebo pills for 12 days every 2 months.~Placebo: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months."
277559|NCT01308814|O2|Outcome|Estradiol|"Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.~Estradiol: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered."
277560|NCT01308814|O1|Outcome|Placebo|"Placebo patches for 12 months and placebo pills for 12 days every 2 months.~Placebo: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months."
277561|NCT01308814|O2|Outcome|Estradiol|"Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.~Estradiol: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered."
277562|NCT01308814|O1|Outcome|Placebo|"Placebo patches for 12 months and placebo pills for 12 days every 2 months.~Placebo: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months."
277563|NCT01308814|O2|Outcome|Estradiol|"Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.~Estradiol: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered."
277564|NCT01308814|O1|Outcome|Placebo|"Placebo patches for 12 months and placebo pills for 12 days every 2 months.~Placebo: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months."
277565|NCT01308814|O2|Outcome|Estradiol|"Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.~Estradiol: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered."
277566|NCT01308814|O1|Outcome|Placebo|"Placebo patches for 12 months and placebo pills for 12 days every 2 months.~Placebo: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months."
277567|NCT01308814|O2|Outcome|Estradiol|"Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.~Estradiol: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered."
277568|NCT01308814|O1|Outcome|Placebo|"Placebo patches for 12 months and placebo pills for 12 days every 2 months.~Placebo: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months."
277569|NCT01308814|O2|Outcome|Estradiol|"Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.~Estradiol: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered."
277570|NCT01308814|O1|Outcome|Placebo|"Placebo patches for 12 months and placebo pills for 12 days every 2 months.~Placebo: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months."
314126|NCT01211145|O3|Outcome|ZOMIG 2.5 mg|ZOMIG nasal spray
277571|NCT01308814|E2|Reported Event|Estradiol|"Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.~Estradiol: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered."
277572|NCT01308814|E1|Reported Event|Placebo|"Placebo patches for 12 months and placebo pills for 12 days every 2 months.~Placebo: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months."
277573|NCT01308788|B3|Baseline|Total|Total of all reporting groups
277574|NCT01308788|B2|Baseline|Aqueous Outflow|aqueous outflow treated
277575|NCT01308788|B1|Baseline|Aqueous Suppressant|aqueous suppressant treated
277576|NCT01308788|P2|Participant Flow|Aqueous Suppressant|aqueous suppressant treated
277577|NCT01308788|P1|Participant Flow|Aqueous Outflow|aqueous outflow treated
277578|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
277579|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
277580|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
277581|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
277582|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
277583|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
277584|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
277585|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
277586|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
277587|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
277588|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
277589|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
277590|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
277591|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
277592|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
277593|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
277594|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
277595|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
277596|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
277597|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
277598|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
277599|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
277600|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
277601|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
277602|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
277603|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
277604|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
277605|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
277606|NCT01308788|E2|Reported Event|Aqueous Suppressant|aqueous suppressant treated
277607|NCT01308788|E1|Reported Event|Aqueous Outflow|aqueous outflow treated
277608|NCT01308762|B4|Baseline|Total|Total of all reporting groups
277609|NCT01308762|B3|Baseline|Group 3|IMM-101 1.0 mg
277610|NCT01308762|B2|Baseline|Group 2|IMM-101 0.5 mg
277611|NCT01308762|B1|Baseline|Group 1|IMM-101 0.1 mg
277612|NCT01308762|P3|Participant Flow|IMM-101 1.0 mg|Patients received an intradermal injection of IMM-101 1.0 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28.
277613|NCT01308762|P2|Participant Flow|IMM-101 0.5 mg|Patients received an intradermal injection of IMM-101 0.5 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28.
277614|NCT01308762|P1|Participant Flow|IMM-101 0.1 mg|Patients received an intradermal injection of IMM-101 0.1 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28.
277615|NCT01308762|O3|Outcome|Group 3|IMM-101 1.0 mg
277616|NCT01308762|O2|Outcome|Group 2|IMM-101 0.5 mg
277617|NCT01308762|O1|Outcome|Group 1|IMM-101 0.1 mg
277618|NCT01308762|O3|Outcome|IMM-101 1.0 mg|IMM-101 was administered on 3 separate occasions to the same individual over a 4 week period (Day 1, 14 and 28).
277619|NCT01308762|O2|Outcome|IMM-101 0.5 mg|IMM-101 was administered on 3 separate occasions to the same individual over a 4 week period (Day 1, 14 and 28).
277620|NCT01308762|O1|Outcome|IMM-101 0.1 mg|IMM-101 was administered on 3 separate occasions to the same individual over a 4 week period (Day 1, 14 and 28).
277621|NCT01308762|E3|Reported Event|Group 3|IMM-101 1.0 mg
277622|NCT01308762|E2|Reported Event|Group 2|IMM-101 0.5 mg
277623|NCT01308762|E1|Reported Event|Group 1|IMM-101 0.1 mg
277624|NCT01308749|B3|Baseline|Total|Total of all reporting groups
277625|NCT01308749|B2|Baseline|Sequence 1: Oxytocin-oxytocin|"Intervention: Drug: Syntocinon® Nasal Spray~Oxytocin: Subjects will use the Syntocinon® Nasal Spray (oxytocin) twice daily for 8 weeks if they are randomized to that arm in the Randomized Phase. All subjects will use the Syntocinon® Nasal Spray twice daily for 8 weeks in the Open Label Phase.~Subjects ages 3-10 years old will be titrated up to a maximum dose of 24 international units (IU). Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU."
277626|NCT01308749|B1|Baseline|Sequence 2:Placebo-oxytocin|"Intervention: Drug: placebo~Placebo: Placebo Nasal Spray"
277627|NCT01308749|P2|Participant Flow|jSequence 2: Placebo-oxytocin|8 weeks of of double blind placebo followed by 8 weeks of open-label oxytocin; this is the control group
277628|NCT01308749|P1|Participant Flow|Sequence 1: Oxytocin-oxytocin|8 weeks of double blind oxytocin followed by 8 weeks of open label oxytocin
277629|NCT01308749|O2|Outcome|Sequence 2: Placebo :Oxytocin|8 weeks of intervention following randomization
277630|NCT01308749|O1|Outcome|Sequence 1: Oxytocin-oxytocin|8 weeks of Intervention following randomization
278677|NCT01305200|B3|Baseline|Arm III (Enrolled Not Randomized)|Site not able to randomize.
277633|NCT01308749|O2|Outcome|Sequence 2: Placebo :Oxytocin|Subjects who received 8 weeks of placebo treatment (baseline to week 8)
277634|NCT01308749|O1|Outcome|Sequence 1: Oxytocin-oxytocin|8 weeks of Intervention: Drug: oxytocin (Syntocinon) baseline to week 8
277635|NCT01308749|O2|Outcome|Sequence 2: Placebo :Oxytocin|"Intervention: Drug: placebo~Placebo: Placebo Nasal Spray"
277636|NCT01308749|O1|Outcome|Sequence 1: Oxytocin-oxytocin|"Intervention: Drug: Syntocinon® Nasal Spray~Oxytocin: Subjects will use the Syntocinon® Nasal Spray (oxytocin) twice daily for 8 weeks if they are randomized to that arm in the Randomized Phase. All subjects will use the Syntocinon® Nasal Spray twice daily for 8 weeks in the Open Label Phase.~Subjects ages 3-10 years old will be titrated up to a maximum dose of 24IU. Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU."
277637|NCT01308749|O2|Outcome|Sequence 2: Placebo :Oxytocin|"Intervention: Drug: placebo~Placebo: Placebo Nasal Spray"
277638|NCT01308749|O1|Outcome|Sequence 1: Oxytocin-oxytocin|"Intervention: Drug: Syntocinon® Nasal Spray~Oxytocin: Subjects will use the Syntocinon® Nasal Spray (oxytocin) twice daily for 8 weeks if they are randomized to that arm in the Randomized Phase. All subjects will use the Syntocinon® Nasal Spray twice daily for 8 weeks in the Open Label Phase.~Subjects ages 3-10 years old will be titrated up to a maximum dose of 24IU. Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU."
277639|NCT01308749|O2|Outcome|Sequence 2: Placebo :Oxytocin|"Intervention: Drug: placebo~Placebo: Placebo Nasal Spray"
277640|NCT01308749|O1|Outcome|Sequence 1: Oxytocin-oxytocin|"Intervention: Drug: Syntocinon® Nasal Spray~Oxytocin: Subjects will use the Syntocinon® Nasal Spray (oxytocin) twice daily for 8 weeks if they are randomized to that arm in the Randomized Phase. All subjects will use the Syntocinon® Nasal Spray twice daily for 8 weeks in the Open Label Phase.~Subjects ages 3-10 years old will be titrated up to a maximum dose of 24IU. Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU."
277641|NCT01308749|O2|Outcome|Sequence 2: Placebo :Oxytocin|placebo x8 weeks then oxytocin x 8weeks
277642|NCT01308749|O1|Outcome|Sequence 1: Oxytocin-oxytocin|"Intervention: Drug: Syntocinon® Nasal Spray~Oxytocin: Subjects will use the Syntocinon® Nasal Spray (oxytocin) twice daily for 8 weeks if they are randomized to that arm in the Randomized Phase. All subjects will use the Syntocinon® Nasal Spray twice daily for 8 weeks in the Open Label Phase.~Subjects ages 3-10 years old will be titrated up to a maximum dose of 24IU. Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU."
277643|NCT01308749|O2|Outcome|Sequence 2: Placebo :Oxytocin|"Intervention: Drug: placebo~Placebo: Placebo Nasal Spray"
277644|NCT01308749|O1|Outcome|Sequence 1: Oxytocin-oxytocin|"Intervention: Drug: Syntocinon® Nasal Spray~Oxytocin: Subjects will use the Syntocinon® Nasal Spray (oxytocin) twice daily for 8 weeks if they are randomized to that arm in the Randomized Phase. All subjects will use the Syntocinon® Nasal Spray twice daily for 8 weeks in the Open Label Phase.~Subjects ages 3-10 years old will be titrated up to a maximum dose of 24IU. Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU."
277645|NCT01308749|O2|Outcome|Sequence 1: Oxytocin:Oxytocin|"Intervention: Drug: Syntocinon® Nasal Spray~Oxytocin: Subjects will use the Syntocinon® Nasal Spray (oxytocin) twice daily for 8 weeks if they are randomized to that arm in the Randomized Phase. All subjects will use the Syntocinon® Nasal Spray twice daily for 8 weeks in the Open Label Phase.~Subjects ages 3-10 years old will be titrated up to a maximum dose of 24IU. Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU."
277646|NCT01308749|O1|Outcome|Sequence 2: Placebo:Oxytocin|"sequence2: placebo:oxytocin~Placebo: Placebo Nasal Spray"
277647|NCT01308749|O2|Outcome|Sequence 2: Oxytocin:Oxytocin|This accounts for all participants starting from baseline to week 16 who received oxytocin the whole time. All participants participants received oxytocin for the full 16 weeks.
277648|NCT01308749|O1|Outcome|Sequence 2: Placebo:Oxytocin|This is accounts for participants from week 0 to week 16. All participants first received placebo (week 0 to week 8) and then subsequently received oxytocin (week 8 to week 16)
277649|NCT01308749|O2|Outcome|Sequence 1: Oxytocin:Oxytocin|"Intervention: Drug: oxytocin = Syntocinon® Nasal Spray~total of 16 weeks exposure Subjects ages 3-10 years old will be titrated up to a maximum dose of 24IU. Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU."
277650|NCT01308749|O1|Outcome|Sequence 2: Placebo:Oxytocin|Intervention: Drug: placebo double blind for 8 weeks then oxytocin open label for 8 weeks
277651|NCT01308749|E4|Reported Event|Sequence 2: Placebo:Oxytocin Period 2|evaluates acute exposure to oxytocin in sequence 2 participants
277652|NCT01308749|E3|Reported Event|Sequence 1: Oxytocin:Oxytocin Period 2, Weeks 8-16|evaluates longer term adverse events with oxytocin
277653|NCT01308749|E2|Reported Event|Sequence 2: Placebo: Oxytocin Period 1 Weeks 0-8|"Intervention: Drug: placebo~Placebo: Placebo Nasal Spray"
277654|NCT01308749|E1|Reported Event|Sequence 1: Oxytocin:Oxytocin Period 1weeks 0-8|"Intervention: Drug: Syntocinon® Nasal Spray~Oxytocin: Subjects will use the Syntocinon® Nasal Spray (oxytocin) twice daily for 8 weeks if they are randomized to that arm in the Randomized Phase. All subjects will use the Syntocinon® Nasal Spray twice daily for 8 weeks in the Open Label Phase.~Subjects ages 3-10 years old will be titrated up to a maximum dose of 24IU. Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU."
277655|NCT01308736|B3|Baseline|Total|Total of all reporting groups
277656|NCT01308736|B2|Baseline|Placebo Pill|Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
277657|NCT01308736|B1|Baseline|Varenicline|Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
277658|NCT01308736|P2|Participant Flow|Placebo Pill|Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
277659|NCT01308736|P1|Participant Flow|Varenicline|Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
277789|NCT01308463|P1|Participant Flow|Discovery Elbow|This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
277660|NCT01308736|O2|Outcome|Placebo Pill|Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
277661|NCT01308736|O1|Outcome|Varenicline|Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
277662|NCT01308736|E2|Reported Event|Placebo Pill|Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
277663|NCT01308736|E1|Reported Event|Varenicline|Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
277664|NCT01308619|B3|Baseline|Total|Total of all reporting groups
277665|NCT01308619|B2|Baseline|Placebo|placebo
277666|NCT01308619|B1|Baseline|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
277667|NCT01308619|P2|Participant Flow|Placebo Capsules|Placebo capsules for 12 weeks
277668|NCT01308619|P1|Participant Flow|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules for 12 weeks
277669|NCT01308619|O2|Outcome|Placebo|placebo
277670|NCT01308619|O1|Outcome|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
277671|NCT01308619|O2|Outcome|Placebo|placebo
277672|NCT01308619|O1|Outcome|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
277673|NCT01308619|O2|Outcome|Treatment Failure|
277674|NCT01308619|O1|Outcome|Treatment Success|
277675|NCT01308619|O2|Outcome|Placebo|placebo
277676|NCT01308619|O1|Outcome|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
277677|NCT01308619|E2|Reported Event|Placebo|placebo
277678|NCT01308619|E1|Reported Event|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
277679|NCT01308580|B3|Baseline|Total|Total of all reporting groups
277680|NCT01308580|B2|Baseline|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277681|NCT01308580|B1|Baseline|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277682|NCT01308580|P2|Participant Flow|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277683|NCT01308580|P1|Participant Flow|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 intravenous (IV) infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until disease progression (DP), unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277684|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277685|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277686|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277687|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277688|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277689|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277690|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277691|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277692|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277693|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277694|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277695|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277696|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277697|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277698|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277699|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277700|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277701|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277702|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277703|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277704|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277705|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277706|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277707|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277708|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277709|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277710|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277711|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277712|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277713|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277714|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277715|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277716|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277717|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277718|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277719|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
277720|NCT01308580|E2|Reported Event|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant’s refusal of further study treatment or for a maximum of 10 cycles.
277721|NCT01308580|E1|Reported Event|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant’s refusal of further study treatment or for a maximum of 10 cycles.
277722|NCT01308567|B4|Baseline|Total|Total of all reporting groups
277723|NCT01308567|B3|Baseline|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277724|NCT01308567|B2|Baseline|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21–day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277725|NCT01308567|B1|Baseline|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277726|NCT01308567|P3|Participant Flow|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277727|NCT01308567|P2|Participant Flow|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21–day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277728|NCT01308567|P1|Participant Flow|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until disease progression (DP), unacceptable toxicity or participant’s refusal.
277729|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277730|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277731|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277732|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277733|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277734|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277735|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277736|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277737|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277738|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277739|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277740|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277741|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277742|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277743|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277744|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277745|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277746|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277747|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277748|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277749|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277750|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277751|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277752|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277753|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277754|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277755|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277756|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277757|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277758|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277759|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277760|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277761|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
277762|NCT01308567|E3|Reported Event|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
277763|NCT01308567|E2|Reported Event|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
277764|NCT01308567|E1|Reported Event|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
277765|NCT01308476|B3|Baseline|Total|Total of all reporting groups
277766|NCT01308476|B2|Baseline|Control Group|Control group with same medication but not receiving reminder SMS.
277767|NCT01308476|B1|Baseline|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
277768|NCT01308476|P2|Participant Flow|Control Group|Control group with same medication but not receiving reminder SMS.
277769|NCT01308476|P1|Participant Flow|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
277770|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
277771|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
277772|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
277773|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
277774|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
277775|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
277776|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
277777|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
277778|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
277779|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
277780|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
277781|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
277782|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
277783|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
277784|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
277785|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
277786|NCT01308476|E2|Reported Event|Control Group|Control group with same medication but not receiving reminder SMS.
277787|NCT01308476|E1|Reported Event|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
277788|NCT01308463|B1|Baseline|Discovery Elbow|This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
277922|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
277790|NCT01308463|O1|Outcome|Discovery Elbow|This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
277791|NCT01308463|O1|Outcome|Discovery Elbow|This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
277792|NCT01308463|O1|Outcome|Discovery Elbow|This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
277793|NCT01308463|O1|Outcome|Discovery Elbow|This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
277794|NCT01308463|E1|Reported Event|Discovery Elbow|This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
277795|NCT01308450|B1|Baseline|Adolescent and Adult Normative Group|"Males and Females from ages 15 -55 divided into 4 age groups: 15-25; 26-35;36-45 and 46-55 with each group having approximately equal representation of both genders. Subjects will be recruited to represent a normative adolescent and adult sampling of subjects who are not known to have ADHD."
277796|NCT01308450|P1|Participant Flow|Adolescent and Adult Normative Group|"Males and Females from ages 15 -55 divided into 4 age groups: 15-25; 26-35;36-45 and 46-55 with each group having approximately equal representation of both genders. Subjects will be recruited to represent a normative adolescent and adult sampling of subjects who are not known to have ADHD."
277797|NCT01308450|O1|Outcome|Adolescent and Adult Normative Group|"Males and Females from ages 15 -55 divided into 4 age groups: 15-25; 26-35;36-45 and 46-55 with each group having approximately equal representation of both genders. Subjects will be recruited to represent a normative adolescent and adult sampling of subjects who are not known to have ADHD."
277798|NCT01308450|E1|Reported Event|Adolescent and Adult Normative Group|"Males and Females from ages 15 -55 divided into 4 age groups: 15-25; 26-35;36-45 and 46-55 with each group having approximately equal representation of both genders. Subjects will be recruited to represent a normative adolescent and adult sampling of subjects who are not known to have ADHD."
277799|NCT01308424|B3|Baseline|Total|Total of all reporting groups
277800|NCT01308424|B2|Baseline|BTL TML HSV|BTL TML HSV : Sublingual micro-dosing for 7 days
277801|NCT01308424|B1|Baseline|Matching Placebo|Matching placebo : sublingual dosing for 7 days
277802|NCT01308424|P3|Participant Flow|BTL TML HSV|BTL TML HSV : Sublingual micro-dosing for 7 days
277803|NCT01308424|P2|Participant Flow|Matching Placebo|Matching placebo : sublingual dosing for 7 days
277804|NCT01308424|P1|Participant Flow|Baseline Run In|Baseline period to assess eligibility before randomization
277805|NCT01308424|O2|Outcome|BTL TML HSV|BTL TML HSV : Sublingual micro-dosing for 7 days
277806|NCT01308424|O1|Outcome|Matching Placebo|Matching placebo : sublingual dosing for 7 days
277807|NCT01308424|E3|Reported Event|BTL TML HSV|BTL TML HSV : Sublingual micro-dosing for 7 days
277808|NCT01308424|E2|Reported Event|Matching Placebo|Matching placebo : sublingual dosing for 7 days
277809|NCT01308424|E1|Reported Event|Baseline Run In|Baseline period to assess eligibility before randomization
277810|NCT01307956|B1|Baseline|Treatment (Panitumumab, Chemotherapy, Radiation)|Patients receive panitumumab IV over 1 hour on day 1. Patients also receive oxaliplatin IV and leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1 (FOLFOX chemotherapy). Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Within 24 hours of the start of chemotherapy, patients undergo radiation therapy 5 days a week for 5.5 weeks. Patients then undergo surgery within 6-8 weeks after completion of radiation therapy. Patients with residual disease receive 4 additional courses of FOLFOX chemotherapy on days 1, 15, 29, and 42.
277811|NCT01307956|P1|Participant Flow|Treatment (Panitumumab, Chemotherapy, Radiation)|Patients receive panitumumab IV over 1 hour on day 1. Patients also receive oxaliplatin IV and leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1 (FOLFOX chemotherapy). Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Within 24 hours of the start of chemotherapy, patients undergo radiation therapy 5 days a week for 5.5 weeks. Patients then undergo surgery within 6-8 weeks after completion of radiation therapy. Patients with residual disease receive 4 additional courses of FOLFOX chemotherapy on days 1, 15, 29, and 42.
277812|NCT01307956|O1|Outcome|Treatment (Panitumumab, Chemotherapy, Radiation)|Patients receive panitumumab IV over 1 hour on day 1. Patients also receive oxaliplatin IV and leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1 (FOLFOX chemotherapy). Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Within 24 hours of the start of chemotherapy, patients undergo radiation therapy 5 days a week for 5.5 weeks. Patients then undergo surgery within 6-8 weeks after completion of radiation therapy. Patients with residual disease receive 4 additional courses of FOLFOX chemotherapy on days 1, 15, 29, and 42.
277813|NCT01307956|E1|Reported Event|Treatment (Panitumumab, Chemotherapy, Radiation)|Patients receive panitumumab IV over 1 hour on day 1. Patients also receive oxaliplatin IV and leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1 (FOLFOX chemotherapy). Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Within 24 hours of the start of chemotherapy, patients undergo radiation therapy 5 days a week for 5.5 weeks. Patients then undergo surgery within 6-8 weeks after completion of radiation therapy. Patients with residual disease receive 4 additional courses of FOLFOX chemotherapy on days 1, 15, 29, and 42.
277814|NCT01307891|B3|Baseline|Total|Total of all reporting groups
277815|NCT01307891|B2|Baseline|Abraxane Alone|Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).
277816|NCT01307891|B1|Baseline|Abraxane + Tigatuzumab|Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.
277923|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277817|NCT01307891|P2|Participant Flow|Abraxane Alone|Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).
277818|NCT01307891|P1|Participant Flow|Abraxane + Tigatuzumab|Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.
277819|NCT01307891|O2|Outcome|Abraxane Alone|Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).
277820|NCT01307891|O1|Outcome|Abraxane + Tigatuzumab|Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.
277821|NCT01307891|O2|Outcome|Abraxane Alone|Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).
277822|NCT01307891|O1|Outcome|Abraxane + Tigatuzumab|Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.
277823|NCT01307891|O2|Outcome|Abraxane Alone|Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).
277824|NCT01307891|O1|Outcome|Abraxane + Tigatuzumab|Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.
277825|NCT01307891|E2|Reported Event|Abraxane Alone|Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Patients will have the option to crossover to the combination arm based upon the pre-clinical data. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).
277826|NCT01307891|E1|Reported Event|Abraxane + Tigatuzumab|Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks.
277827|NCT01307787|B3|Baseline|Total|Total of all reporting groups
277828|NCT01307787|B2|Baseline|Waiting List Control Group|The waiting list control group did not have an intervention during the evaluation part of the study.The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
277829|NCT01307787|B1|Baseline|Fit-program|"Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component. The physical exercise part took place in group sessions and consisted of a muscle exercise circuit and bicycle training once a week for sixty minutes, sport once a week for sixty minutes and aqua jogging twice a week for thirty minutes.~The educational part consisted of a weekly sixty minutes session. A multi-disciplinary group of healthcare professionals consisting of a psychologist, physical therapist, occupational therapist, dietician and a social worker gave specialist orientated informational advice about how to handle the consequences of RA. Special attention was paid to ensure adjusting the level of each patients activity level to the participants’ actual energy level."
277830|NCT01307787|P2|Participant Flow|Waiting List Control Group|The waiting list control group did not have an intervention during the evaluation part of the study.The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
277831|NCT01307787|P1|Participant Flow|Fit-program|"Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component. The physical exercise part took place in group sessions and consisted of a muscle exercise circuit and bicycle training once a week for sixty minutes, sport once a week for sixty minutes and aqua jogging twice a week for thirty minutes.~The educational part consisted of a weekly sixty minutes session. A multi-disciplinary group of healthcare professionals consisting of a psychologist, physical therapist, occupational therapist, dietician and a social worker gave specialist orientated informational advice about how to handle the consequences of RA. Special attention was paid to ensure adjusting the level of each patients activity level to the participants’ actual energy level."
277832|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention, allowed to follow the program after the study
277833|NCT01307787|O1|Outcome|Intervention Fitprogram Group|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component
277834|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention, allowed to follow the program after the study
277835|NCT01307787|O1|Outcome|Intervention Fitprogram Group|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component
277836|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention, allowed to follow the program after the study
277837|NCT01307787|O1|Outcome|Intervention Fitprogram Group|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component
277838|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention, allowed to follow the program after the study
277839|NCT01307787|O1|Outcome|Intervention Fitprogram Group|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component
277840|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention, allowed to follow the program after the study
277841|NCT01307787|O1|Outcome|Intervention Fitprogram Group|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component
277842|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention, allowed to follow the program after the study
277843|NCT01307787|O1|Outcome|Intervention Fitprogram Group|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component.
277844|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention. WLC was allowed to follow the program after the study.
277845|NCT01307787|O1|Outcome|Intervention Fit Program|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component.
277846|NCT01307787|O2|Outcome|Waiting List Control Group|No intervention. The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
277847|NCT01307787|O1|Outcome|Intervention Fit Program|An eight week multi-disciplinary group-therapy program for people with RA, consisting of physical exercise designed to increase aerobic capacity and muscle strength together with an educational program to improve health status and self-efficacy for disease-self-management.
277848|NCT01307787|E2|Reported Event|Waiting List Control Group|The waiting list control group did not have an intervention during the evaluation part of the study.The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
277849|NCT01307787|E1|Reported Event|Fit-program|"Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component. The physical exercise part took place in group sessions and consisted of a muscle exercise circuit and bicycle training once a week for sixty minutes, sport once a week for sixty minutes and aqua jogging twice a week for thirty minutes.~The educational part consisted of a weekly sixty minutes session. A multi-disciplinary group of healthcare professionals consisting of a psychologist, physical therapist, occupational therapist, dietician and a social worker gave specialist orientated informational advice about how to handle the consequences of RA. Special attention was paid to ensure adjusting the level of each patients activity level to the participants’ actual energy level."
277850|NCT01307631|B1|Baseline|Treatment (Akt Inhibitor MK2206|"Patients receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
277851|NCT01307631|P2|Participant Flow|Treatment (Akt Inhibitor MK2206) Wild Type|"Patients with wild type receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
277852|NCT01307631|P1|Participant Flow|Treatment (Akt Inhibitor MK2206) PIK3CA Mutation|"Patients with PIK3CA mutation receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
277853|NCT01307631|O2|Outcome|Treatment (Akt Inhibitor MK2206) Wild Type|"Patients with wild type receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
277854|NCT01307631|O1|Outcome|Treatment (Akt Inhibitor MK2206) PIK3CA Mutation|"Patients with PIK3CA mutation receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
277855|NCT01307631|O1|Outcome|Treatment (Akt Inhibitor MK2206|"Patients receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
277856|NCT01307631|O1|Outcome|Treatment (Akt Inhibitor MK2206|"Patients receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
277857|NCT01307631|O1|Outcome|Treatment (Akt Inhibitor MK2206|"Patients receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
277858|NCT01307631|E1|Reported Event|Treatment (Akt Inhibitor MK2206|"Patients receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
277859|NCT01307618|B3|Baseline|Total|Total of all reporting groups
277860|NCT01307618|B2|Baseline|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
277861|NCT01307618|B1|Baseline|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
277862|NCT01307618|P2|Participant Flow|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
277884|NCT01307462|O1|Outcome|Treatment (BOS Therapy)|Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
278120|NCT01307020|O7|Outcome|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
277863|NCT01307618|P1|Participant Flow|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
277864|NCT01307618|O2|Outcome|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
277865|NCT01307618|O1|Outcome|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
277866|NCT01307618|O2|Outcome|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
277867|NCT01307618|O1|Outcome|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
277868|NCT01307618|O2|Outcome|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
277869|NCT01307618|O1|Outcome|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
277870|NCT01307618|O2|Outcome|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
277871|NCT01307618|O1|Outcome|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
277872|NCT01307618|O2|Outcome|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
277873|NCT01307618|O1|Outcome|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
277874|NCT01307618|O2|Outcome|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
277875|NCT01307618|O1|Outcome|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
277876|NCT01307618|E2|Reported Event|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
277877|NCT01307618|E1|Reported Event|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
277878|NCT01307462|B1|Baseline|Treatment (BOS Therapy)|Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
277879|NCT01307462|P1|Participant Flow|Treatment (BOS Therapy)|Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
277880|NCT01307462|O1|Outcome|Treatment (BOS Therapy)|Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
277881|NCT01307462|O1|Outcome|Treatment (BOS Therapy)|Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
277882|NCT01307462|O1|Outcome|Treatment (BOS Therapy)|Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
277883|NCT01307462|O1|Outcome|Treatment (BOS Therapy)|Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
277921|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277885|NCT01307462|O1|Outcome|Treatment (BOS Therapy)|Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
277886|NCT01307462|O1|Outcome|Treatment (BOS Therapy)|Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
277887|NCT01307462|O1|Outcome|Treatment (BOS Therapy)|Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
277888|NCT01307462|O1|Outcome|Treatment (BOS Therapy)|Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
277889|NCT01307462|O1|Outcome|Treatment (BOS Therapy)|Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
277890|NCT01307462|E1|Reported Event|Treatment (BOS Therapy)|Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
277891|NCT01307423|B4|Baseline|Total|Total of all reporting groups
277892|NCT01307423|B3|Baseline|Apremilast 30mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
277893|NCT01307423|B2|Baseline|Apremilast 20mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
277894|NCT01307423|B1|Baseline|Placebo|Participants initially randomized to receive placebo tablets twice daily.
277895|NCT01307423|P7|Participant Flow|Placebo / Apremilast 30 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 to receive 30 mg apremilast for up to 4.5 years.
277896|NCT01307423|P6|Participant Flow|Placebo / Apremilast 30 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 30 mg apremilast for up to 4.5 years.
277897|NCT01307423|P5|Participant Flow|Placebo / Apremilast 20 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 (XO) to receive 20 mg apremilast for up to 4.5 years
277898|NCT01307423|P4|Participant Flow|Placebo/ 20mg Apremilast EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 20 mg apremilast for up to 4.5 years.
277899|NCT01307423|P3|Participant Flow|Apremilast 30mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 30 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
277900|NCT01307423|P2|Participant Flow|Apremilast 20mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 20 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
277901|NCT01307423|P1|Participant Flow|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
277902|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277903|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277904|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
277905|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277906|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277907|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
277908|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277909|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277910|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
277911|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277912|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277913|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
277914|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277915|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277916|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
277917|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277918|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277919|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
277920|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277924|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277925|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
277926|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277927|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277928|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
277929|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277930|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277931|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
277932|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277933|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277934|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
277935|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277936|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277937|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
277938|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277939|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277940|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
277941|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277942|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277943|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
277944|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277945|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277946|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
277947|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277948|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277949|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
277950|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277951|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277952|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
277953|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277954|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277955|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
277956|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277957|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277958|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
277959|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277960|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277961|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
277962|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277963|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277964|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
277965|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277966|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277967|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
277968|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277969|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277970|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
277971|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277972|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277973|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
277974|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277975|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277976|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
277977|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277978|NCT01307423|O2|Outcome|Apremilast 20mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277979|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
277980|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277981|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277982|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
277983|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277984|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277985|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
277986|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277987|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277988|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
277989|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277990|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277991|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
277992|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
277993|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
277994|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
277995|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
277996|NCT01307423|O2|Outcome|Apremilast 20mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
277997|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
277998|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
277999|NCT01307423|O2|Outcome|Apremilast 20mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
278000|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
278001|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
278002|NCT01307423|O2|Outcome|Apremilast 20mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
278003|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
278004|NCT01307423|E5|Reported Event|Week 52: Apremilast 30 mg|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Week 52.
278005|NCT01307423|E4|Reported Event|Week 52: Apremilast 20 mg|Participants who received 20 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Week 52.
278006|NCT01307423|E3|Reported Event|Week 24: Apremilast 30 mg|Participants randomized to receive 30 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
278007|NCT01307423|E2|Reported Event|Week 24: Apremilast 20 mg|Participants randomized to receive 20 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
278008|NCT01307423|E1|Reported Event|Week 24: Placebo|Participants randomized to placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for participants who escaped early, and through Week 24 for all other participants.
278009|NCT01307397|B1|Baseline|Vemurafenib|Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
278121|NCT01307020|O6|Outcome|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
278010|NCT01307397|P1|Participant Flow|Vemurafenib|Participants received continuous oral doses of vemurafenib 960 milligrams (mg) (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
278011|NCT01307397|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
278012|NCT01307397|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
278013|NCT01307397|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
278014|NCT01307397|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
278015|NCT01307397|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
278016|NCT01307397|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
278017|NCT01307397|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
278018|NCT01307397|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
278019|NCT01307397|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
278020|NCT01307397|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
278021|NCT01307397|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
278022|NCT01307397|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
278023|NCT01307397|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
278024|NCT01307397|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
278025|NCT01307397|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
278026|NCT01307397|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
278027|NCT01307397|E1|Reported Event|Vemurafenib|Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
278028|NCT01307319|B4|Baseline|Total|Total of all reporting groups
278029|NCT01307319|B3|Baseline|Placebo Nasal Aerosol Once Daily|Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
278030|NCT01307319|B2|Baseline|BDP HFA 160 mcg/Day|Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
278031|NCT01307319|B1|Baseline|BDP HFA 80 mcg/Day|Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
278032|NCT01307319|P3|Participant Flow|Placebo Nasal Aerosol Once Daily|Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
278033|NCT01307319|P2|Participant Flow|BDP HFA 160 mcg/Day|Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
278034|NCT01307319|P1|Participant Flow|BDP HFA 80 mcg/Day|Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
278035|NCT01307319|O3|Outcome|Placebo Nasal Aerosol Once Daily|Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
278036|NCT01307319|O2|Outcome|BDP HFA 160 mcg/Day|Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
278037|NCT01307319|O1|Outcome|BDP HFA 80 mcg/Day|Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
278038|NCT01307319|O3|Outcome|Placebo Nasal Aerosol Once Daily|Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
278039|NCT01307319|O2|Outcome|BDP HFA 160 mcg/Day|Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
278040|NCT01307319|O1|Outcome|BDP HFA 80 mcg/Day|Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
278041|NCT01307319|E3|Reported Event|Placebo Nasal Aerosol Once Daily|Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
278042|NCT01307319|E2|Reported Event|BDP HFA 160 mcg/Day|Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
278043|NCT01307319|E1|Reported Event|BDP HFA 80 mcg/Day|Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
278044|NCT01307111|B4|Baseline|Total|Total of all reporting groups
278045|NCT01307111|B3|Baseline|Not Randomized|Women not eligible to continue to randomization.
278046|NCT01307111|B2|Baseline|Placebo|Pills which are identical to the study drug in appearance, taste, and smell.
278047|NCT01307111|B1|Baseline|Misoprostol|Misoprostol 400 micrograms inserted buccally or vaginally, per the participants desire.
278048|NCT01307111|P2|Participant Flow|Placebo|"Pills which are identical to the study drug in appearance, taste, and smell.~Placebo: Pills which are identical to the study drug in appearance, taste, and smell."
278049|NCT01307111|P1|Participant Flow|Misoprostol|"Misoprostol 400 micrograms inserted buccally or vaginally, per the participants desire.~Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion."
278050|NCT01307111|O2|Outcome|Placebo|Placebo: Pills which are identical to the study drug in appearance, taste, and smell.
278051|NCT01307111|O1|Outcome|Misoprostol|Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.
278052|NCT01307111|O2|Outcome|Placebo|Placebo: Pills which are identical to the study drug in appearance, taste, and smell.
278053|NCT01307111|O1|Outcome|Misoprostol|Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.
278054|NCT01307111|E2|Reported Event|Placebo|Placebo: Pills which are identical to the study drug in appearance, taste, and smell.
278055|NCT01307111|E1|Reported Event|Misoprostol|Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.
278056|NCT01307046|B3|Baseline|Total|Total of all reporting groups
278057|NCT01307046|B2|Baseline|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
278058|NCT01307046|B1|Baseline|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
278059|NCT01307046|P2|Participant Flow|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
278060|NCT01307046|P1|Participant Flow|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
278061|NCT01307046|O2|Outcome|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
278062|NCT01307046|O1|Outcome|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
278063|NCT01307046|O2|Outcome|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
278064|NCT01307046|O1|Outcome|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
278065|NCT01307046|O2|Outcome|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
278066|NCT01307046|O1|Outcome|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
278067|NCT01307046|E2|Reported Event|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
278068|NCT01307046|E1|Reported Event|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
278069|NCT01307033|B3|Baseline|Total|Total of all reporting groups
278070|NCT01307033|B2|Baseline|MK-0954A (L100/H12.5)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension.
278071|NCT01307033|B1|Baseline|MK-0954H (L50/H12.5)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
278072|NCT01307033|P4|Participant Flow|L100/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension
278073|NCT01307033|P3|Participant Flow|L50/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
278074|NCT01307033|P2|Participant Flow|MK-0954A (L100/H12.5) Double Blind Period (Period 1)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5)
278075|NCT01307033|P1|Participant Flow|MK-0954H (L50/H12.5) Double Blind Period (Period 1)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5)
278076|NCT01307033|O2|Outcome|L100/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension
278077|NCT01307033|O1|Outcome|L50/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
278078|NCT01307033|O2|Outcome|MK-0954A (L100/H12.5)|One combination tablet daily for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5)
278079|NCT01307033|O1|Outcome|MK-0954H (L50/H12.5)|One combination tablet daily for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5)
278080|NCT01307033|O2|Outcome|MK-0954A (L100/H12.5)|One combination tablet daily for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5).
278081|NCT01307033|O1|Outcome|MK-0954H (L50/H12.5)|One combination tablet daily for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5).
278082|NCT01307033|E4|Reported Event|L100/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension
278083|NCT01307033|E3|Reported Event|L50/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
278084|NCT01307033|E2|Reported Event|MK-0954A (L100/H12.5) Double Blind Period (Period 1)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5)
278085|NCT01307033|E1|Reported Event|MK-0954H (L50/H12.5) Double Blind Period (Period 1)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5)
278086|NCT01307020|B11|Baseline|Total|Total of all reporting groups
278087|NCT01307020|B10|Baseline|Placebo|Placebo oral film-coated tablet, once
278088|NCT01307020|B9|Baseline|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
278089|NCT01307020|B8|Baseline|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
278090|NCT01307020|B7|Baseline|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
278091|NCT01307020|B6|Baseline|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
278092|NCT01307020|B5|Baseline|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
278093|NCT01307020|B4|Baseline|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
278094|NCT01307020|B3|Baseline|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
278095|NCT01307020|B2|Baseline|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
278096|NCT01307020|B1|Baseline|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
278097|NCT01307020|P10|Participant Flow|Placebo|Placebo oral film-coated tablet, once
278098|NCT01307020|P9|Participant Flow|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
278099|NCT01307020|P8|Participant Flow|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
278100|NCT01307020|P7|Participant Flow|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
278101|NCT01307020|P6|Participant Flow|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
278102|NCT01307020|P5|Participant Flow|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
278103|NCT01307020|P4|Participant Flow|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
278104|NCT01307020|P3|Participant Flow|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
278105|NCT01307020|P2|Participant Flow|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
278106|NCT01307020|P1|Participant Flow|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
278107|NCT01307020|O10|Outcome|Placebo|Placebo oral film-coated tablet, once
278108|NCT01307020|O9|Outcome|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
278109|NCT01307020|O8|Outcome|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
278110|NCT01307020|O7|Outcome|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
278111|NCT01307020|O6|Outcome|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
278112|NCT01307020|O5|Outcome|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
278113|NCT01307020|O4|Outcome|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
278114|NCT01307020|O3|Outcome|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
278115|NCT01307020|O2|Outcome|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
278116|NCT01307020|O1|Outcome|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
278117|NCT01307020|O10|Outcome|Placebo|Placebo oral film-coated tablet, once
278118|NCT01307020|O9|Outcome|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
278119|NCT01307020|O8|Outcome|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
278123|NCT01307020|O4|Outcome|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
278124|NCT01307020|O3|Outcome|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
278125|NCT01307020|O2|Outcome|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
278126|NCT01307020|O1|Outcome|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
278127|NCT01307020|O10|Outcome|Placebo|Placebo oral film-coated tablet, once
278128|NCT01307020|O9|Outcome|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
278129|NCT01307020|O8|Outcome|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
278130|NCT01307020|O7|Outcome|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
278131|NCT01307020|O6|Outcome|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
278132|NCT01307020|O5|Outcome|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
278133|NCT01307020|O4|Outcome|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
278134|NCT01307020|O3|Outcome|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
278135|NCT01307020|O2|Outcome|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
278136|NCT01307020|O1|Outcome|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
278137|NCT01307020|E10|Reported Event|Placebo|Placebo oral film-coated tablet, once
278138|NCT01307020|E9|Reported Event|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
278139|NCT01307020|E8|Reported Event|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
278140|NCT01307020|E7|Reported Event|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
278141|NCT01307020|E6|Reported Event|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
278142|NCT01307020|E5|Reported Event|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
278143|NCT01307020|E4|Reported Event|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
278144|NCT01307020|E3|Reported Event|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
278145|NCT01307020|E2|Reported Event|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
278146|NCT01307020|E1|Reported Event|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
278147|NCT01307007|B3|Baseline|Total|Total of all reporting groups
278148|NCT01307007|B2|Baseline|Iron Dextran Injection|Iron Dextran Injection : Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.
278149|NCT01307007|B1|Baseline|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0
278150|NCT01307007|P2|Participant Flow|Iron Dextran Injection|Iron Dextran Injection : Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.
278151|NCT01307007|P1|Participant Flow|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0
278152|NCT01307007|O2|Outcome|Iron Dextran Injection|Iron Dextran Injection: Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.
278153|NCT01307007|O1|Outcome|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM): 15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0
278154|NCT01307007|E2|Reported Event|Iron Dextran Injection|Iron Dextran Injection : Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.
278155|NCT01307007|E1|Reported Event|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0
278156|NCT01306968|B5|Baseline|Total|Total of all reporting groups
278157|NCT01306968|B4|Baseline|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)~sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
278158|NCT01306968|B3|Baseline|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday~hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
278159|NCT01306968|B2|Baseline|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
278160|NCT01306968|B1|Baseline|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
278161|NCT01306968|P4|Participant Flow|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)~sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
278162|NCT01306968|P3|Participant Flow|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday~hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
278163|NCT01306968|P2|Participant Flow|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
278164|NCT01306968|P1|Participant Flow|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
278165|NCT01306968|O4|Outcome|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)~sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
278166|NCT01306968|O3|Outcome|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday~hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
278167|NCT01306968|O2|Outcome|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
278168|NCT01306968|O1|Outcome|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
278169|NCT01306968|O4|Outcome|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)~sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
278170|NCT01306968|O3|Outcome|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday~hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
278171|NCT01306968|O2|Outcome|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
278172|NCT01306968|O1|Outcome|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
278173|NCT01306968|O4|Outcome|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)~sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
278174|NCT01306968|O3|Outcome|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday~hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
278175|NCT01306968|O2|Outcome|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD) Follow-up visit 2 = Day 56 (up to day 100)
278176|NCT01306968|O1|Outcome|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
278177|NCT01306968|O4|Outcome|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)~sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
278948|NCT01304238|O4|Outcome|Fondaparinux|Participants treated with fondaparinux after HIT II
278178|NCT01306968|O3|Outcome|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday. Each subject will complete 40 sessions.~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
278179|NCT01306968|O2|Outcome|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
278180|NCT01306968|O1|Outcome|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
278181|NCT01306968|E4|Reported Event|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)~sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
278182|NCT01306968|E3|Reported Event|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday~hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
278183|NCT01306968|E2|Reported Event|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
278184|NCT01306968|E1|Reported Event|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
278185|NCT01306877|B3|Baseline|Total|Total of all reporting groups
278186|NCT01306877|B2|Baseline|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
278187|NCT01306877|B1|Baseline|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
278188|NCT01306877|P2|Participant Flow|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set : Surgical device
278189|NCT01306877|P1|Participant Flow|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set : Surgical device
278190|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
278191|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
278192|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
278193|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
278194|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
278195|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
278196|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
278197|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
278198|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
278199|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
278200|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
278201|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
278202|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
278203|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
278204|NCT01306877|E2|Reported Event|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
278205|NCT01306877|E1|Reported Event|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
278206|NCT01306643|B1|Baseline|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
278207|NCT01306643|P1|Participant Flow|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
278208|NCT01306643|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
278209|NCT01306643|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
278210|NCT01306643|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
278211|NCT01306643|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
278212|NCT01306643|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
278213|NCT01306643|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
278214|NCT01306643|E1|Reported Event|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
278215|NCT01306617|B4|Baseline|Total|Total of all reporting groups
278317|NCT01306214|B3|Baseline|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
278216|NCT01306617|B3|Baseline|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
278217|NCT01306617|B2|Baseline|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278218|NCT01306617|B1|Baseline|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278219|NCT01306617|P3|Participant Flow|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
278220|NCT01306617|P2|Participant Flow|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278221|NCT01306617|P1|Participant Flow|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278222|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
278223|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278224|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278225|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
278226|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278227|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278228|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
278229|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278230|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278231|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
278232|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278233|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278234|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
278235|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278236|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278237|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
278238|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278239|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278240|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
278241|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278318|NCT01306214|B2|Baseline|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
278242|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278243|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
278244|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278245|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278246|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
278247|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278248|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278249|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
278250|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278251|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278252|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
278253|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278254|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278255|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
278256|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278257|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278258|NCT01306617|E3|Reported Event|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
278259|NCT01306617|E2|Reported Event|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naive|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278260|NCT01306617|E1|Reported Event|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naive|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
278261|NCT01306305|B3|Baseline|Total|Total of all reporting groups
278262|NCT01306305|B2|Baseline|Elderly|Elderly subjects aged over 60 years
278263|NCT01306305|B1|Baseline|Adults|Adults from 18 to 60 years old inclusive
278264|NCT01306305|P2|Participant Flow|Elderly|Elderly subjects aged over 60 years
278265|NCT01306305|P1|Participant Flow|Adults|Adults from 18 to 60 years old inclusive
278266|NCT01306305|O2|Outcome|Elderly|Elderly subjects aged over 60 years
278267|NCT01306305|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
278268|NCT01306305|O2|Outcome|Elderly|Elderly subjects aged over 60 years
278269|NCT01306305|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
278270|NCT01306305|O2|Outcome|Elderly|Elderly subjects aged over 60 years
278271|NCT01306305|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
278272|NCT01306305|O2|Outcome|Elderly|Elderly subjects aged over 60 years
278273|NCT01306305|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
278274|NCT01306305|O2|Outcome|Elderly|Elderly subjects aged over 60 years
278275|NCT01306305|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
278276|NCT01306305|E2|Reported Event|Elderly|Elderly subjects aged over 60 years
278277|NCT01306305|E1|Reported Event|Adults|Adults from 18 to 60 years old inclusive
278278|NCT01306292|B3|Baseline|Total|Total of all reporting groups
278279|NCT01306292|B2|Baseline|Normal Group|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure <25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL.
278949|NCT01304238|O3|Outcome|Danaparoid|Participants treated with danaparoid after HIT II
278280|NCT01306292|B1|Baseline|Hypertension Group|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL.
278281|NCT01306292|P4|Participant Flow|Normal Group (Placebo First, Then SonoVue)|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure <25.0 mmHg) who were randomized to receive Placebo (normal saline 0.9% for injection) first, then SonoVue. Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes.
278282|NCT01306292|P3|Participant Flow|Normal Group (SonoVue First, Then Placebo)|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure <25.0 mmHg) who were randomized to receive SonoVue first, then Placebo (normal saline 0.9% for injection). Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes.
278283|NCT01306292|P2|Participant Flow|Hypertension Group (Placebo First, Then SonoVue)|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥25.0 mmHg) who were randomized to receive Placebo (normal saline 0.9% for injection) first, then SonoVue. Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes.
278284|NCT01306292|P1|Participant Flow|Hypertension Group (SonoVue First, Then Placebo)|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who were randomized to receive SonoVue first, then Placebo (normal saline 0.9% for injection). Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes.
278285|NCT01306292|O4|Outcome|Normal SonoVue|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure < 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.
278286|NCT01306292|O3|Outcome|Normal Placebo|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure < 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.
278287|NCT01306292|O2|Outcome|Hypertension SonoVue|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.
278288|NCT01306292|O1|Outcome|Hypertension Placebo|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.
278289|NCT01306292|O4|Outcome|Normal SonoVue|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure < 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.
278290|NCT01306292|O3|Outcome|Normal Placebo|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure < 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.
278291|NCT01306292|O2|Outcome|Hypertension SonoVue|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.
278292|NCT01306292|O1|Outcome|Hypertension Placebo|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.
278293|NCT01306292|O4|Outcome|Normal SonoVue|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure < 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.
278294|NCT01306292|O3|Outcome|Normal Placebo|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure < 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.
278295|NCT01306292|O2|Outcome|Hypertension SonoVue|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.
278296|NCT01306292|O1|Outcome|Hypertension Placebo|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.
278297|NCT01306292|E2|Reported Event|Normal Pulmonary Pressure Group|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure <25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL. An interval of at least 10 minutes was allowed between the two injections (SonoVue and Placebo). All adverse events occurred hours after the completion of both injections and for the purposes of this study have been assigned to the administration of SonoVue.
278298|NCT01306292|E1|Reported Event|Hypertension Group|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL. An interval of at least 10 minutes was allowed between the two injections (SonoVue and Placebo). All adverse events occurred hours after the completion of both injections and for the purposes of this study have been assigned to the administration of SonoVue.
278299|NCT01306253|B3|Baseline|Total|Total of all reporting groups
278300|NCT01306253|B2|Baseline|Elderly|Elderly subjects aged over 60 years
278301|NCT01306253|B1|Baseline|Adults|Adults from 18 to 60 years old inclusive
278302|NCT01306253|P2|Participant Flow|Elderly|Elderly subjects aged over 60 years
278303|NCT01306253|P1|Participant Flow|Adults|Adults from 18 to 60 years old inclusive
278304|NCT01306253|O2|Outcome|Elderly|Elderly subjects aged over 60 years
278305|NCT01306253|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
278306|NCT01306253|O2|Outcome|Elderly|Elderly subjects aged over 60 years
278307|NCT01306253|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
278308|NCT01306253|O2|Outcome|Elderly|Elderly subjects aged over 60 years
278309|NCT01306253|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
278310|NCT01306253|O2|Outcome|Elderly|Elderly subjects aged over 60 years
278311|NCT01306253|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
278312|NCT01306253|O2|Outcome|Elderly|Elderly subjects aged over 60 years
278319|NCT01306214|B1|Baseline|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
278320|NCT01306214|P3|Participant Flow|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
278321|NCT01306214|P2|Participant Flow|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
278322|NCT01306214|P1|Participant Flow|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
278323|NCT01306214|O3|Outcome|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
278324|NCT01306214|O2|Outcome|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
278325|NCT01306214|O1|Outcome|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
278326|NCT01306214|O3|Outcome|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
278327|NCT01306214|O2|Outcome|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
278328|NCT01306214|O1|Outcome|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
278329|NCT01306214|O3|Outcome|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
278330|NCT01306214|O2|Outcome|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
278331|NCT01306214|O1|Outcome|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
278332|NCT01306214|O3|Outcome|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
278333|NCT01306214|O2|Outcome|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
278334|NCT01306214|O1|Outcome|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
278335|NCT01306214|E3|Reported Event|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
278336|NCT01306214|E2|Reported Event|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
278337|NCT01306214|E1|Reported Event|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
278338|NCT01306201|B1|Baseline|In-patient Volunteers|In-patients from the hospital who choose to participate in the study
278339|NCT01306201|P1|Participant Flow|Respiration Rate in GCF Patients|In-patients from the hospital general care floor, who choose to participate in the study. Participants were monitored for 30 minute periods to collect respiratory rate information from non-invasive sensors.
278340|NCT01306201|O1|Outcome|In-patient Volunteers|In-patients from the hospital who choose to participate in the study
278341|NCT01306201|O1|Outcome|Overall Study Population|Covidien Respiration Rate, Transthoracic Impedance and Overscored Endtidal Carbon Dioxide derived respiration rates were recorded on all the volunteers simultaneously.
278342|NCT01306201|O3|Outcome|Respiration Rate From Transthoracic Impedance|Respiration Rate derived from Transthoracic Impedance
278343|NCT01306201|O2|Outcome|Respiration Rate From Endtidal Carbon Dioxide Waveform|Respiration rate determined by manual overscoring of capnography waveforms
278344|NCT01306201|O1|Outcome|Respiration Rate From Covidien Respiration Rate Software|Respiration rate determined by novel plethysmographic analysis
278345|NCT01306201|E1|Reported Event|In-patient Volunteers|In-patients from the hospital who choose to participate in the study
278346|NCT01306175|B1|Baseline|Study Total|"This was a randomised, two-period, cross-over trial, the two treatments administered were~A single dose of digoxin 0.5 mg on day 1~Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5~Between treatment periods there was a washout period of at least 14 days."
278347|NCT01306175|P1|Participant Flow|Study Total|"This was a randomised, two-period cross-over trial, the two treatments administered were~A single dose of 0.5mg digoxin on day 1~empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5~Between treatment periods there was a washout period of at least 14 days."
278348|NCT01306175|O2|Outcome|Digoxin and Empa|Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5.
278349|NCT01306175|O1|Outcome|Digoxin Alone|A single dose of digoxin 0.5 mg on day 1.
278350|NCT01306175|O2|Outcome|Digoxin and Empa|Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5.
278351|NCT01306175|O1|Outcome|Digoxin Alone|A single dose of digoxin 0.5 mg on day 1.
278352|NCT01306175|O2|Outcome|Digoxin and Empa|Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5.
278353|NCT01306175|O1|Outcome|Digoxin Alone|A single dose of digoxin 0.5 mg on day 1.
278354|NCT01306175|E2|Reported Event|Digoxin and Empa|Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5.
278355|NCT01306175|E1|Reported Event|Digoxin Alone|A single dose of digoxin 0.5 mg on day 1.
278356|NCT01306162|B5|Baseline|Total|Total of all reporting groups
278357|NCT01306162|B4|Baseline|TrtC -- TrtE -- TrtD -- TrtA|Dabigatran 150mg + Dronedarone 400mg given 2h later (Trt. C), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg (Trt. A)
278358|NCT01306162|B3|Baseline|TrtB -- TrtD -- TrtE -- TrtA|Dabigatran 150mg + Dronedarone 400mg given simultaneously (Trt. B), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg (Trt. A)
278359|NCT01306162|B2|Baseline|TrtA -- TrtC -- TrtE -- TrtD|Dabigatran 150mg (Trt. A), followed by Dabigatran 150mg + Dronedarone 400mg given 2h later (Trt. C), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D)
278360|NCT01306162|B1|Baseline|TrtA -- TrtB -- TrtD -- TrtE|Dabigatran 150mg (Trt. A), followed by Dabigatran 150mg + Dronedarone 400mg given simultaneously (Trt. B), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E)
278361|NCT01306162|P4|Participant Flow|TrtC -- TrtE -- TrtD -- TrtA|Dabigatran 150mg + Dronedarone 400mg given 2h later (Trt. C), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg (Trt. A)
278362|NCT01306162|P3|Participant Flow|TrtB -- TrtD -- TrtE -- TrtA|Dabigatran 150mg + Dronedarone 400mg given simultaneously (Trt. B), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg (Trt. A)
278363|NCT01306162|P2|Participant Flow|TrtA -- TrtC -- TrtE -- TrtD|Dabigatran 150mg (Trt. A), followed by Dabigatran 150mg + Dronedarone 400mg given 2h later (Trt. C), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D)
278364|NCT01306162|P1|Participant Flow|TrtA -- TrtB -- TrtD -- TrtE|Dabigatran 150mg (Trt. A), followed by Dabigatran 150mg + Dronedarone 400mg given simultaneously (Trt. B), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E)
278365|NCT01306162|O5|Outcome|150mg DE + 400mg DR Bid 2h Later (TrtE)|Dabigatran 150mg + Dronedarone 400mg bid given 2h later
278366|NCT01306162|O4|Outcome|150mg DE + 400mg DR Bid Same Time (TrtD)|Dabigatran 150mg + Dronedarone 400mg bid given simultaneously
278367|NCT01306162|O3|Outcome|150mg DE + 400mg DR 2h Later (TrtC)|Dabigatran 150mg + Dronedarone 400mg given 2h later
278368|NCT01306162|O2|Outcome|150mg DE + 400mg DR (TrtB)|Dabigatran 150mg + Dronedarone 400mg given simultaneously
278369|NCT01306162|O1|Outcome|150mg DE (TrtA)|Dabigatran 150mg
278370|NCT01306162|O5|Outcome|150mg DE + 400mg DR Bid 2h Later (TrtE)|Dabigatran 150mg + Dronedarone 400mg bid given 2h later
278371|NCT01306162|O4|Outcome|150mg DE + 400mg DR Bid Same Time (TrtD)|Dabigatran 150mg + Dronedarone 400mg bid given simultaneously
278372|NCT01306162|O3|Outcome|150mg DE + 400mg DR 2h Later (TrtC)|Dabigatran 150mg + Dronedarone 400mg given 2h later
278373|NCT01306162|O2|Outcome|150mg DE + 400mg DR (TrtB)|Dabigatran 150mg + Dronedarone 400mg given simultaneously
278374|NCT01306162|O1|Outcome|150mg DE (TrtA)|Dabigatran 150mg
278375|NCT01306162|O5|Outcome|150mg DE + 400mg DR Bid 2h Later (TrtE)|Dabigatran 150mg + Dronedarone 400mg bid given 2h later
278376|NCT01306162|O4|Outcome|150mg DE + 400mg DR Bid Same Time (TrtD)|Dabigatran 150mg + Dronedarone 400mg bid given simultaneously
278377|NCT01306162|O3|Outcome|150mg DE + 400mg DR 2h Later (TrtC)|Dabigatran 150mg + Dronedarone 400mg given 2h later
278378|NCT01306162|O2|Outcome|150mg DE + 400mg DR (TrtB)|Dabigatran 150mg + Dronedarone 400mg given simultaneously
278379|NCT01306162|O1|Outcome|150mg DE (TrtA)|Dabigatran 150mg
278380|NCT01306162|O5|Outcome|150mg DE + 400mg DR Bid 2h Later (TrtE)|Dabigatran 150mg + Dronedarone 400mg bid given 2h later
278381|NCT01306162|O4|Outcome|150mg DE + 400mg DR Bid Same Time (TrtD)|Dabigatran 150mg + Dronedarone 400mg bid given simultaneously
278382|NCT01306162|O3|Outcome|150mg DE + 400mg DR 2h Later (TrtC)|Dabigatran 150mg + Dronedarone 400mg given 2h later
278383|NCT01306162|O2|Outcome|150mg DE + 400mg DR (TrtB)|Dabigatran 150mg + Dronedarone 400mg given simultaneously
278384|NCT01306162|O1|Outcome|150mg DE (TrtA)|Dabigatran 150mg
278385|NCT01306162|E6|Reported Event|400mg DR + 400mg DR Bid 2h Later (TrtE2)|Dronedarone 400mg + Dronedarone 400mg bid given 2h later
278386|NCT01306162|E5|Reported Event|150mg DE + 400mg DR Bid 2h Later (TrtE)|Dabigatran 150mg + Dronedarone 400mg bid given 2h later
278387|NCT01306162|E4|Reported Event|150mg DE + 400mg DR Bid Same Time (TrtD)|Dabigatran 150mg + Dronedarone 400mg bid given simultaneously
278388|NCT01306162|E3|Reported Event|150mg DE + 400mg DR 2h Later (TrtC)|Dabigatran 150mg + Dronedarone 400mg given 2h later
278389|NCT01306162|E2|Reported Event|150mg DE + 400mg DR (TrtB)|Dabigatran 150mg + Dronedarone 400mg given simultaneously
278390|NCT01306162|E1|Reported Event|150mg DE (TrtA)|Dabigatran 150mg
278391|NCT01306058|B1|Baseline|Sorafenib & TRC105 in Hepatocellular CA|"CA (cancer); 15 mg/kg TRC105 intravenous (IV) every 2 weeks and 400 mg sorafenib by mouth (PO) twice per day~TRC 105: 15 mg/kg IV every 2 weeks~Sorafenib: 400 mg twice a day (bid) continuously in a 28 days cycle"
278392|NCT01306058|P1|Participant Flow|Sorafenib & TRC105 in Hepatocellular CA|"CA (cancer); 15 mg/kg TRC105 intravenous (IV) every 2 weeks and 400 mg sorafenib by mouth (PO) twice per day~TRC 105: 15 mg/kg IV every 2 weeks~Sorafenib: 400 mg twice a day (bid) continuously in a 28 days cycle"
278393|NCT01306058|O1|Outcome|Sorafenib & TRC105 in Hepatocellular CA|"CA (cancer); 15 mg/kg TRC105 intravenous (IV) every 2 weeks and 400 mg sorafenib by mouth (PO) twice per day~TRC 105: 15 mg/kg IV every 2 weeks~Sorafenib: 400 mg twice a day (bid) continuously in a 28 days cycle"
278394|NCT01306058|O1|Outcome|Sorafenib & TRC105 in Hepatocellular CA|"CA (cancer); 15 mg/kg TRC105 intravenous (IV) every 2 weeks and 400 mg sorafenib by mouth (PO) twice per day~TRC 105: 15 mg/kg IV every 2 weeks~Sorafenib: 400 mg twice a day (bid) continuously in a 28 days cycle"
278395|NCT01306058|O1|Outcome|Sorafenib & TRC105 in Hepatocellular CA|"CA (cancer); 15 mg/kg TRC105 intravenous (IV) every 2 weeks and 400 mg sorafenib by mouth (PO) twice per day~TRC 105: 15 mg/kg IV every 2 weeks~Sorafenib: 400 mg twice a day (bid) continuously in a 28 days cycle"
278396|NCT01306058|O1|Outcome|Sorafenib & TRC105 in Hepatocellular CA|"CA (cancer); 15 mg/kg TRC105 intravenous (IV) every 2 weeks and 400 mg sorafenib by mouth (PO) twice per day~TRC 105: 15 mg/kg IV every 2 weeks~Sorafenib: 400 mg twice a day (bid) continuously in a 28 days cycle"
278397|NCT01306058|O1|Outcome|Sorafenib & TRC105 in Hepatocellular CA|"CA (cancer); 15 mg/kg TRC105 intravenous (IV) every 2 weeks and 400 mg sorafenib by mouth (PO) twice per day~TRC 105: 15 mg/kg IV every 2 weeks~Sorafenib: 400 mg twice a day (bid) continuously in a 28 days cycle"
278398|NCT01306058|O1|Outcome|Sorafenib & TRC105 in Hepatocellular CA|"CA (cancer); 15 mg/kg TRC105 intravenous (IV) every 2 weeks and 400 mg sorafenib by mouth (PO) twice per day~TRC 105: 15 mg/kg IV every 2 weeks~Sorafenib: 400 mg twice a day (bid) continuously in a 28 days cycle"
278399|NCT01306058|O1|Outcome|Sorafenib & TRC105 in Hepatocellular CA|"CA (cancer); 15 mg/kg TRC105 intravenous (IV) every 2 weeks and 400 mg sorafenib by mouth (PO) twice per day~TRC 105: 15 mg/kg IV every 2 weeks~Sorafenib: 400 mg twice a day (bid) continuously in a 28 days cycle"
278400|NCT01306058|O1|Outcome|Sorafenib & TRC105 in Hepatocellular CA|"CA (cancer); 15 mg/kg TRC105 intravenous (IV) every 2 weeks and 400 mg sorafenib by mouth (PO) twice per day~TRC 105: 15 mg/kg IV every 2 weeks~Sorafenib: 400 mg twice a day (bid) continuously in a 28 days cycle"
278401|NCT01306058|O1|Outcome|Sorafenib & TRC105 in Hepatocellular CA|"CA (cancer); 15 mg/kg TRC105 intravenous (IV) every 2 weeks and 400 mg sorafenib by mouth (PO) twice per day~TRC 105: 15 mg/kg IV every 2 weeks~Sorafenib: 400 mg twice a day (bid) continuously in a 28 days cycle"
278402|NCT01306058|O1|Outcome|Sorafenib & TRC105 in Hepatocellular CA|"CA (cancer); 15 mg/kg TRC105 intravenous (IV) every 2 weeks and 400 mg sorafenib by mouth (PO) twice per day~TRC 105: 15 mg/kg IV every 2 weeks~Sorafenib: 400 mg twice a day (bid) continuously in a 28 days cycle"
278403|NCT01306058|O1|Outcome|Sorafenib & TRC105 in Hepatocellular CA|"CA (cancer); 15 mg/kg TRC105 intravenous (IV) every 2 weeks and 400 mg sorafenib by mouth (PO) twice per day~TRC 105: 15 mg/kg IV every 2 weeks~Sorafenib: 400 mg twice a day (bid) continuously in a 28 days cycle"
278404|NCT01306058|O1|Outcome|Sorafenib & TRC105 in Hepatocellular CA|"CA (cancer); 15 mg/kg TRC105 intravenous (IV) every 2 weeks and 400 mg sorafenib by mouth (PO) twice per day~TRC 105: 15 mg/kg IV every 2 weeks~Sorafenib: 400 mg twice a day (bid) continuously in a 28 days cycle"
278405|NCT01306058|O1|Outcome|Sorafenib & TRC105 in Hepatocellular CA|"CA (cancer); 15 mg/kg TRC105 intravenous (IV) every 2 weeks and 400 mg sorafenib by mouth (PO) twice per day~TRC 105: 15 mg/kg IV every 2 weeks~Sorafenib: 400 mg twice a day (bid) continuously in a 28 days cycle"
278406|NCT01306058|O1|Outcome|Sorafenib & TRC105 in Hepatocellular CA|"CA (cancer); 15 mg/kg TRC105 intravenous (IV) every 2 weeks and 400 mg sorafenib by mouth (PO) twice per day~TRC 105: 15 mg/kg IV every 2 weeks~Sorafenib: 400 mg twice a day (bid) continuously in a 28 days cycle"
278407|NCT01306058|O1|Outcome|Sorafenib & TRC105 in Hepatocellular CA|"CA (cancer); 15 mg/kg TRC105 intravenous (IV) every 2 weeks and 400 mg sorafenib by mouth (PO) twice per day~TRC 105: 15 mg/kg IV every 2 weeks~Sorafenib: 400 mg twice a day (bid) continuously in a 28 days cycle"
278408|NCT01306058|O1|Outcome|Sorafenib & TRC105 in Hepatocellular CA|"CA (cancer); 15 mg/kg TRC105 intravenous (IV) every 2 weeks and 400 mg sorafenib by mouth (PO) twice per day~TRC 105: 15 mg/kg IV every 2 weeks~Sorafenib: 400 mg twice a day (bid) continuously in a 28 days cycle"
278409|NCT01306058|O1|Outcome|Sorafenib & TRC105 in Hepatocellular CA|"CA (cancer); 15 mg/kg TRC105 intravenous (IV) every 2 weeks and 400 mg sorafenib by mouth (PO) twice per day~TRC 105: 15 mg/kg IV every 2 weeks~Sorafenib: 400 mg twice a day (bid) continuously in a 28 days cycle"
278410|NCT01306058|E1|Reported Event|Sorafenib & TRC105 in Hepatocellular CA|"CA (cancer); 15 mg/kg TRC105 intravenous (IV) every 2 weeks and 400 mg sorafenib by mouth (PO) twice per day~TRC 105: 15 mg/kg IV every 2 weeks~Sorafenib: 400 mg twice a day (bid) continuously in a 28 days cycle"
278411|NCT01306032|B7|Baseline|Total|Total of all reporting groups
278412|NCT01306032|B6|Baseline|Non-Hodgkin’s: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
278413|NCT01306032|B5|Baseline|Non-Hodgkin’s: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO).
278414|NCT01306032|B4|Baseline|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
278415|NCT01306032|B3|Baseline|BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO).
278416|NCT01306032|B2|Baseline|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
278417|NCT01306032|B1|Baseline|Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO).
278418|NCT01306032|P6|Participant Flow|Non-Hodgkin's: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days. Participants in the cyclophosphamide alone arm crossed over to the ABT-888 plus cyclophosphamide arm at time of disease progression.
278419|NCT01306032|P5|Participant Flow|Non-Hodgkin's: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278420|NCT01306032|P4|Participant Flow|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days. Participants in the cyclophosphamide alone arm crossed over to the ABT-888 plus cyclophosphamide arm at time of disease progression.
278421|NCT01306032|P3|Participant Flow|BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278422|NCT01306032|P2|Participant Flow|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days. Participants in the cyclophosphamide alone arm crossed over to the ABT-888 plus cyclophosphamide arm at time of disease progression.
278423|NCT01306032|P1|Participant Flow|Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278424|NCT01306032|O8|Outcome|Non-Hodgkin’s: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
278425|NCT01306032|O7|Outcome|Non-Hodgkin’s: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278426|NCT01306032|O6|Outcome|Triple-negative Breast Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278427|NCT01306032|O5|Outcome|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
278428|NCT01306032|O4|Outcome|Triple-negative Breast Cancer: Cyclophosphamide & ABT-888|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth on a continuous schedule.
278429|NCT01306032|O3|Outcome|BRCA-positive Ovarian Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278430|NCT01306032|O2|Outcome|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
278499|NCT01305772|B1|Baseline|Radiation Therapy|Patients who underwent radiation therapy only, in conjunction with panitumumab therapy
278431|NCT01306032|O1|Outcome|BRCA-positive Ovarian Cancer: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278432|NCT01306032|O8|Outcome|Non-Hodgkin’s: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
278433|NCT01306032|O7|Outcome|Non-Hodgkin’s: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278434|NCT01306032|O6|Outcome|Triple-negative Breast Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278435|NCT01306032|O5|Outcome|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
278436|NCT01306032|O4|Outcome|Triple-negative Breast Cancer: Cyclophosphamide & ABT-888|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth on a continuous schedule.
278437|NCT01306032|O3|Outcome|BRCA-positive Ovarian Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278438|NCT01306032|O2|Outcome|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
278439|NCT01306032|O1|Outcome|BRCA-positive Ovarian Cancer: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278440|NCT01306032|O8|Outcome|Non-Hodgkin’s: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
278441|NCT01306032|O7|Outcome|Non-Hodgkin’s: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278442|NCT01306032|O6|Outcome|Triple-negative Breast Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278443|NCT01306032|O5|Outcome|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
278444|NCT01306032|O4|Outcome|Triple-negative Breast Cancer: Cyclophosphamide & ABT-888|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth on a continuous schedule.
278445|NCT01306032|O3|Outcome|BRCA-positive Ovarian Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278446|NCT01306032|O2|Outcome|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
278447|NCT01306032|O1|Outcome|BRCA-positive Ovarian Cancer: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278448|NCT01306032|O8|Outcome|Non-Hodgkin’s: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
278449|NCT01306032|O7|Outcome|Non-Hodgkin’s: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278450|NCT01306032|O6|Outcome|Triple-negative Breast Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278451|NCT01306032|O5|Outcome|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
278452|NCT01306032|O4|Outcome|Triple-negative Breast Cancer: Cyclophosphamide & ABT-888|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth on a continuous schedule.
278453|NCT01306032|O3|Outcome|BRCA-positive Ovarian Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278454|NCT01306032|O2|Outcome|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
278455|NCT01306032|O1|Outcome|BRCA-positive Ovarian Cancer: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278456|NCT01306032|O4|Outcome|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
278457|NCT01306032|O3|Outcome|BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278458|NCT01306032|O2|Outcome|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
278459|NCT01306032|O1|Outcome|Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278460|NCT01306032|O6|Outcome|BRCA-positive Ovarian Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278461|NCT01306032|O5|Outcome|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
278462|NCT01306032|O4|Outcome|BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278463|NCT01306032|O3|Outcome|Triple-negative Breast Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278464|NCT01306032|O2|Outcome|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
278465|NCT01306032|O1|Outcome|Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278466|NCT01306032|E8|Reported Event|Non-Hodgkin’s: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
278467|NCT01306032|E7|Reported Event|Non-Hodgkin’s: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278468|NCT01306032|E6|Reported Event|Triple-negative Breast Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278469|NCT01306032|E5|Reported Event|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
278470|NCT01306032|E4|Reported Event|Triple-negative Breast Cancer: Cyclophosphamide & ABT-888|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278950|NCT01304238|O2|Outcome|Lepirudin|Participants treated with lepirudin after HIT II
278471|NCT01306032|E3|Reported Event|BRCA-positive Ovarian Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278472|NCT01306032|E2|Reported Event|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
278473|NCT01306032|E1|Reported Event|BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
278474|NCT01305941|B1|Baseline|Everolimus +Vinorelbine + Trastuzumab|"daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab~Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets~Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.~Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly"
278475|NCT01305941|P1|Participant Flow|Everolimus +Vinorelbine + Trastuzumab|"daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab~Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets~Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.~Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly"
278476|NCT01305941|O1|Outcome|Everolimus +Vinorelbine + Trastuzumab|"daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab~Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets~Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.~Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly"
278477|NCT01305941|O1|Outcome|Everolimus +Vinorelbine + Trastuzumab|"daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab~Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets~Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.~Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly"
278478|NCT01305941|O1|Outcome|Everolimus +Vinorelbine + Trastuzumab|"daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab~Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets~Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.~Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly"
278479|NCT01305941|O1|Outcome|Everolimus +Vinorelbine + Trastuzumab|"daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab~Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets~Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.~Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly"
278480|NCT01305941|O1|Outcome|Everolimus +Vinorelbine + Trastuzumab|"daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab~Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets~Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.~Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly"
278481|NCT01305941|O1|Outcome|Everolimus +Vinorelbine + Trastuzumab|"daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab~Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets~Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.~Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly"
278482|NCT01305941|O1|Outcome|Everolimus +Vinorelbine + Trastuzumab|"daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab~Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets~Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.~Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly"
278483|NCT01305941|O1|Outcome|Everolimus +Vinorelbine + Trastuzumab|"daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab~Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets~Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.~Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly"
278484|NCT01305941|O1|Outcome|Everolimus +Vinorelbine + Trastuzumab|"daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab~Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets~Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.~Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly"
278485|NCT01305941|E1|Reported Event|Everolimus +Vinorelbine + Trastuzumab|"daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab~Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets~Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.~Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly"
278486|NCT01305811|B3|Baseline|Total|Total of all reporting groups
278487|NCT01305811|B2|Baseline|Wait List|Wait list for 2 months then weekly acupuncture for four months
278488|NCT01305811|B1|Baseline|Bi-weekly Acupuncture Treatment|Bi-weekly acupuncture treatment for 6 months
278489|NCT01305811|P2|Participant Flow|Wait List|Veterans with diagnosed symptoms of Gulf War Illness were randomized to 2 months of waitlist followed by weekly acupuncture treatments for 4 months.
278490|NCT01305811|P1|Participant Flow|Bi-weekly Acupuncture Treatment|Veterans with diagnosed symptoms of Gulf War Illness were randomized to six months of biweekly acupuncture treatments.
278491|NCT01305811|O2|Outcome|Wait List|"Wait list for 2 months.~Acupuncture: Sterile insertive needles are applied by licensed, experienced practitioners."
278492|NCT01305811|O1|Outcome|Bi-weekly Acupuncture Treatment|"Bi-weekly acupuncture treatment~Acupuncture: Sterile insertive needles are applied by licensed, experienced practitioners."
278493|NCT01305811|O2|Outcome|Wait List Then Weekly Acupuncture|group mean SF-36 P score at 6 months
278494|NCT01305811|O1|Outcome|Bi-Weekly Acupuncture|group mean SF-36 P score at 6 months
278495|NCT01305811|E2|Reported Event|Wait List|"Wait list for 2 months followed by 4 months of weekly acupuncture~No Adverse events were reported in the Wait list group"
278496|NCT01305811|E1|Reported Event|Bi-Weekly Acupuncture|"Bi-Weekly Acupuncture for 6 months~1 serious unexpected adverse event in the biweekly group: Subject’s practitioner was told by subject of a suicide attempt. Case was reviewed and the medical monitor and identified as needing follow up. Subject was hospitalized for observation, released to his daughter’s custody. Both the VA and the Crisis Center were in touch with him on Feb 27th and are making arrangements to take him, (patient reported), either in patient or into a program. He had a follow-up appointment Feb 28th at the VA and he was hospitalized at this time and is currently hospitalized.~The practitioner will also follow up with subject’s PCP."
278497|NCT01305772|B3|Baseline|Total|Total of all reporting groups
278498|NCT01305772|B2|Baseline|Surgery|Patients who underwent surgery after research PET/CT scans and subsequent radiation therapy with panitumumab administration
278500|NCT01305772|P2|Participant Flow|Surgery|"Patients who underwent surgery after research PET/CT scans and subsequent radiation therapy with panitumumab administration~Panitumumab : Single dose Panitumumab 9mg/kg IV for a total of 3 doses (if tolerated). Dose #1 is to be administered prior to RT for RT arm. Within the surgery arm, second and third doses of panitumumab were administered after surgery during weeks 1 & 4 of RT. Within the RT arm, second and third doses will be administered at weeks 1 & 4 during RT.~Surgery : Second biopsy was taken from surgical resection tissue (when possible obtained pre and post panitumumab biopsies from the same site)."
278501|NCT01305772|P1|Participant Flow|Radiation Therapy|"Patients who underwent radiation therapy only, in conjunction with panitumumab therapy.~Radiation Therapy : Radiation therapy was initiated within 8 weeks after surgery, or as soon as possible.~Panitumumab : Single dose Panitumumab 9mg/kg IV for a total of 3 doses (if tolerated). Dose #1 is to be administered prior to RT for RT arm. Within the surgery arm, second and third doses of panitumumab were administered after surgery during weeks 1 & 4 of RT. Within the RT arm, second and third doses will be administered at weeks 1 & 4 during RT."
278502|NCT01305772|O1|Outcome|Overall Study|Patients from both the Surgery and RT arms will be combined in reporting primary and secondary outcome results, as one arm only contains 1 subject. Statistical uncertainty cannot be measured about 1 subject.
278503|NCT01305772|O1|Outcome|Overall Study|Patients from both the Surgery and RT arms will be combined in reporting primary and secondary outcome results, as one arm only contains 1 subject. Statistical uncertainty cannot be measured about 1 subject.
278504|NCT01305772|O1|Outcome|Overall Study|Patients from both the Surgery and RT arms will be combined in reporting primary and secondary outcome results, as one arm only contains 1 subject. Statistical uncertainty cannot be measured about 1 subject.
278505|NCT01305772|E2|Reported Event|Surgery|Surgery after research PET/CT scans and subsequent radiation therapy with panitumumab therapy.
278506|NCT01305772|E1|Reported Event|Radiation Therapy|Radiation therapy with panitumumab therapy.
278507|NCT01305655|B1|Baseline|Glucarpidase Arm|"In the NOPHO ALL-2008 protocol patients with delayed methotrexate elimination (DME) in high-dose methotrexate treatments should be given Glucarpidase (50 ie/kg) with-in 60 hours from start of the methotrexate treatment.~Glucarpidase: Patients treated with Glucarpidase if the 24 hour levels of MTX is >250 µM, 36 hour levels >30 µM or 42 hours levels >10 µM together with a reduced kidney function will be compared with patients in just below the tricking values."
278508|NCT01305655|P1|Participant Flow|Glucarpidase Arm|In children treated with high dose MTX (HDMTX) according to the NOPHO ALL 2008 protocol, Glucarpidase was used in case of predefined toxic MTX values at defined time points in combination with decreased renal function.
278509|NCT01305655|O1|Outcome|Glucarpidase Arm|47 children treated with high dose MTX (HDMTX) according to the NOPHO ALL 2008 protocol, Glucarpidase was used in case of predefined toxic MTX values at defined time points in combination with decreased renal function.
278510|NCT01305655|E1|Reported Event|Glucarpidase Arm|"In the NOPHO ALL-2008 protocol patients with delayed methotrexate elimination (DME) in high-dose methotrexate treatments should be given Glucarpidase (50 ie/kg) with-in 60 hours from start of the methotrexate treatment.~Glucarpidase: Patients treated with Glucarpidase if the 24 hour levels of MTX is >250 µM, 36 hour levels >30 µM or 42 hours levels >10 µM together with a reduced kidney function will be compared with patients in just below the tricking values.~No serious effect reported."
278511|NCT01305577|B4|Baseline|Total|Total of all reporting groups
278512|NCT01305577|B3|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278513|NCT01305577|B2|Baseline|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278514|NCT01305577|B1|Baseline|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278515|NCT01305577|P3|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278516|NCT01305577|P2|Participant Flow|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278517|NCT01305577|P1|Participant Flow|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278518|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278519|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278520|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278521|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278522|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278523|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278524|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278562|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
278525|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278526|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278527|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278528|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278529|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278530|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278531|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278532|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278533|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278534|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278535|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278536|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278537|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278538|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278539|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278540|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278541|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278542|NCT01305577|E3|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278543|NCT01305577|E2|Reported Event|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278544|NCT01305577|E1|Reported Event|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
278545|NCT01305564|B1|Baseline|Baseline Characteristics|All treated with Denali filter.
278546|NCT01305564|P1|Participant Flow|Denali Inferior Vena Cava Filter|"All subjects enrolled will receive the Denali vena cava filter.~Denali inferior vena cava filter: The Denali inferior vena cava filter is a mechanical filtration device consisting of two levels of filtration (upper arms, lower legs), a retrieval hook to allow for retrieval using a standard snare, cranial and caudal anchors, and penetration limiters. The Denali filter is made from a laser cut nitinol tube."
278547|NCT01305564|O1|Outcome|Filter Penetration at Retrieval|
278548|NCT01305564|O1|Outcome|Filter Penetration at Placement|
278549|NCT01305564|O1|Outcome|Filter Tilt|At Retrieval
278550|NCT01305564|O1|Outcome|Filter Tilt|At Implant
278551|NCT01305564|O1|Outcome|Filter Migration >2 cm|
278552|NCT01305564|O1|Outcome|Filter Fracture|
278553|NCT01305564|O1|Outcome|New or Worsening DVT|
278554|NCT01305564|O1|Outcome|Recurrent PE|
278555|NCT01305564|O1|Outcome|Clinical Success of Retrieval|
278556|NCT01305564|O1|Outcome|Technical Success of Retrieval|
278557|NCT01305564|O1|Outcome|Clinical Success of Placement|
278558|NCT01305564|O1|Outcome|Technical Success of Placement|Primary implant endpoint
278559|NCT01305564|E1|Reported Event|Serious Adverse Events|"Serious Adverse Events are reported for all 200 subjects and all serious events are reported.~Non-serious adverse events are reported when the reported threshold for an event is at 5% or higher. This represents 175 subjects and not 200 for non-serious events."
278560|NCT01305473|B1|Baseline|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
278561|NCT01305473|P1|Participant Flow|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
314127|NCT01211145|O2|Outcome|ZOMIG 0.5 mg|ZOMIG nasal spray
278563|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
278564|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
278565|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
278566|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
278567|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
278568|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
278569|NCT01305473|E1|Reported Event|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
278570|NCT01305408|B3|Baseline|Total|Total of all reporting groups
278571|NCT01305408|B2|Baseline|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
278572|NCT01305408|B1|Baseline|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
278573|NCT01305408|P2|Participant Flow|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
278574|NCT01305408|P1|Participant Flow|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
278575|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
278576|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
278577|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
278578|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
278579|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
278580|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
278581|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
278582|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
278583|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
278584|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
278585|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
278586|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
278587|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
278588|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
278589|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
278590|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
278591|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
278592|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
278593|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
278594|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
278595|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
278596|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
278597|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
278598|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
278599|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
278600|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
278601|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
278602|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
278603|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
278604|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
278605|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
278606|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
278607|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
278608|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
278609|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
278610|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
278611|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
278612|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
278613|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
278614|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
278615|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
278616|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
278617|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
278618|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
278619|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
278620|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
278621|NCT01305408|E2|Reported Event|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
278622|NCT01305408|E1|Reported Event|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
278623|NCT01305265|B3|Baseline|Total|Total of all reporting groups
278624|NCT01305265|B2|Baseline|Intervention Group|Endotracheal tube cuff inflated using the inflate & palpate technique. The cuff pressure then was adjusted to 22-26cmH2O within 15min after endotracheal intubation by trained study staff.
278625|NCT01305265|B1|Baseline|Control Group|Endotracheal tube cuff inflated using the inflate & palpate technique
278626|NCT01305265|P2|Participant Flow|Intervention Group|Endotracheal tube cuff will be inflated using the inflate & palpate technique. The cuff pressure will be adjusted to 22-26cmH2O within 15min after intubation by trained study staff.
278627|NCT01305265|P1|Participant Flow|Control Group|Endotracheal tube cuff will be inflated using the inflate&palpate technique
278628|NCT01305265|O2|Outcome|Intervention Group|Endotracheal tube cuff will be inflated using the inflate & palpate technique. The cuff pressure will be adjusted to 22-26cmH2O within 15min after intubation by trained study staff.
278629|NCT01305265|O1|Outcome|Control Group|Endotracheal tube cuff will be inflated using the inflate&palpate technique
278675|NCT01305213|E1|Reported Event|Arm I Bevacizumab|Bevacizumab 15mg/kg IV Day 1 every 3 weeks
278676|NCT01305200|B4|Baseline|Total|Total of all reporting groups
278630|NCT01305265|E2|Reported Event|Intervention Group|Endotracheal tube cuff will be inflated using the inflate & palpate technique. The cuff pressure will be adjusted to 22-26cmH2O within 15min after intubation by trained study staff.
278631|NCT01305265|E1|Reported Event|Control Group|Endotracheal tube cuff will be inflated using the inflate&palpate technique
278632|NCT01305252|B3|Baseline|Total|Total of all reporting groups
278633|NCT01305252|B2|Baseline|Tadalafil and Treprostinil Inhalations|"inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.~tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
278634|NCT01305252|B1|Baseline|Tadalafil Alone|"tadalafil 40mg QD~tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
278635|NCT01305252|P2|Participant Flow|Tadalafil and Treprostinil Inhalations|"inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.~tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
278636|NCT01305252|P1|Participant Flow|Tadalafil Alone|"tadalafil 40mg QD~tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
278637|NCT01305252|O2|Outcome|Tadalafil and Treprostinil Inhalations|"inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.~tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
278638|NCT01305252|O1|Outcome|Tadalafil Alone|"tadalafil 40mg QD~tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
278639|NCT01305252|O2|Outcome|Tadalafil and Treprostinil Inhalations|"Inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.~Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
278640|NCT01305252|O1|Outcome|Tadalafil Alone|"Tadalafil 40mg QD~Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
278641|NCT01305252|O2|Outcome|Tadalafil Alone|"Tadalafil 40mg QD~Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
278642|NCT01305252|O1|Outcome|Tadalafil and Treprostinil Inhalations|"Inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.~Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
278643|NCT01305252|O2|Outcome|Tadalafil and Treprostinil Inhalations|"Inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.~Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
278644|NCT01305252|O1|Outcome|Tadalafil Alone|"Tadalafil 40mg QD~Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
278645|NCT01305252|O2|Outcome|Tadalafil Alone|"Tadalafil 40mg QD~Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
278646|NCT01305252|O1|Outcome|Tadalafil and Treprostinil Inhalations|"Inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.~Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
278647|NCT01305252|E2|Reported Event|Tadalafil and Treprostinil Inhalations|"inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.~tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
278648|NCT01305252|E1|Reported Event|Tadalafil Alone|"tadalafil 40mg QD~tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
278649|NCT01305239|B1|Baseline|Exemestane|25 mg oral tablet once a day
278650|NCT01305239|P1|Participant Flow|Exemestane|25 mg oral tablet once a day
278651|NCT01305239|O1|Outcome|Exemestane|25 mg oral tablet once a day
278652|NCT01305239|O1|Outcome|Exemestane|25 mg oral tablet once a day
278653|NCT01305239|O1|Outcome|Exemestane|25 mg oral tablet once a day
278654|NCT01305239|O1|Outcome|Exemestane|25 mg oral tablet once a day
278655|NCT01305239|O1|Outcome|Exemestane|25 mg oral tablet once a day
278656|NCT01305239|E1|Reported Event|Exemestane|25 mg oral tablet once a day
278657|NCT01305213|B3|Baseline|Total|Total of all reporting groups
278658|NCT01305213|B2|Baseline|Arm II Bevacizumab + Fosbretabulin|Bevacizumab 15mg/kg IV Day 1 every 3 weeks plus fosbretabulin tromethamine 60mg/m2 IV Day 1 every 3 weeks
278659|NCT01305213|B1|Baseline|Arm I Bevacizumab|Bevacizumab 15mg/kg IV Day 1 every 3 weeks
278660|NCT01305213|P2|Participant Flow|Arm II Bevacizumab + Fosbretabulin|Bevacizumab 15mg/kg IV Day 1 every 3 weeks plus fosbretabulin tromethamine 60mg/m2 IV Day 1 every 3 weeks
278661|NCT01305213|P1|Participant Flow|Arm I Bevacizumab|Bevacizumab 15mg/kg IV Day 1 every 3 weeks
278662|NCT01305213|O2|Outcome|Arm II Bevacizumab + Fosbretabulin|Bevacizumab 15mg/kg IV Day 1 every 3 weeks plus fosbretabulin tromethamine 60mg/m2 IV Day 1 every 3 weeks
278663|NCT01305213|O1|Outcome|Arm I Bevacizumab|Bevacizumab 15mg/kg IV Day 1 every 3 weeks
278664|NCT01305213|O2|Outcome|Measurable Disease Patients|Patients with measurable disease
278665|NCT01305213|O1|Outcome|Non Measurble Disease|Patients with non measurable disease
278666|NCT01305213|O2|Outcome|Arm II Bevacizumab + Fosbretabulin|Bevacizumab 15mg/kg IV Day 1 every 3 weeks plus fosbretabulin tromethamine 60mg/m2 IV Day 1 every 3 weeks
278667|NCT01305213|O1|Outcome|Arm I Bevacizumab|Bevacizumab 15mg/kg IV Day 1 every 3 weeks
278668|NCT01305213|O2|Outcome|Measurable Disease Patients|Patients with measurable disease
278669|NCT01305213|O1|Outcome|Non Measurable Disease Patients|Patients with non measurable disease
278670|NCT01305213|O2|Outcome|Arm II Bevacizumab + Fosbretabulin|Bevacizumab 15mg/kg IV Day 1 every 3 weeks plus fosbretabulin tromethamine 60mg/m2 IV Day 1 every 3 weeks
278671|NCT01305213|O1|Outcome|Arm I Bevacizumab|Bevacizumab 15mg/kg IV Day 1 every 3 weeks
278672|NCT01305213|O2|Outcome|Arm II Bevacizumab + Fosbretabulin|Bevacizumab 15mg/kg IV Day 1 every 3 weeks plus fosbretabulin tromethamine 60mg/m2 IV Day 1 every 3 weeks
278673|NCT01305213|O1|Outcome|Arm I Bevacizumab|Bevacizumab 15mg/kg IV Day 1 every 3 weeks
278674|NCT01305213|E2|Reported Event|Arm II Bevacizumab + Fosbretabulin|Bevacizumab 15mg/kg IV Day 1 every 3 weeks plus fosbretabulin tromethamine 60mg/m2 IV Day 1 every 3 weeks
278678|NCT01305200|B2|Baseline|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278679|NCT01305200|B1|Baseline|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278680|NCT01305200|P3|Participant Flow|Arm III (Enrolled But Not Randomized)|Site not randomized
278681|NCT01305200|P2|Participant Flow|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278682|NCT01305200|P1|Participant Flow|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278683|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278684|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278685|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278686|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278687|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278688|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278689|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278690|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278691|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278692|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278693|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278694|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278695|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278696|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278697|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278698|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278699|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278700|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278701|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278702|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278703|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278704|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278705|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278706|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278707|NCT01305200|E2|Reported Event|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278708|NCT01305200|E1|Reported Event|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
278709|NCT01305044|B3|Baseline|Total|Total of all reporting groups
278710|NCT01305044|B2|Baseline|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
278711|NCT01305044|B1|Baseline|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
278712|NCT01305044|P2|Participant Flow|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
278713|NCT01305044|P1|Participant Flow|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
278714|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
278715|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
278716|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
278779|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
278717|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
278718|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
278719|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
278720|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
278721|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
278722|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
278723|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
278724|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
278725|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
278726|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
278727|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
278728|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
278729|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
278730|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
278731|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
278732|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
278780|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
278781|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
278733|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
278734|NCT01305044|E2|Reported Event|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
278735|NCT01305044|E1|Reported Event|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
278736|NCT01304966|B1|Baseline|Children With Recurrent Respiratory Papillomatosis|Children hospitalized with recurrent respiratory papillomatosis who underwent biopsy
278737|NCT01304966|P1|Participant Flow|Children With Recurrent Respiratory Papillomatosis|Children hospitalized with recurrent respiratory papillomatosis who underwent biopsy
278738|NCT01304966|O2|Outcome|HPV 11|Children with recurrent respiratory papillomatosis from HPV 11
278739|NCT01304966|O1|Outcome|HPV 6|Children with recurrent respiratory papillomatosis from HPV 6
278740|NCT01304966|O1|Outcome|Children With Recurrent Respiratory Papillomatosis|Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy
278741|NCT01304966|E1|Reported Event|Children With Recurrent Respiratory Papillomatosis|Children hospitalized with recurrent respiratory papillomatosis who underwent biopsy
278742|NCT01304706|B1|Baseline|Fluocinolone Acetonide|Fluocinolone Acetonide: 0.2 μg/day
278743|NCT01304706|P1|Participant Flow|Fluocinolone Acetonide|Fluocinolone Acetonide: 0.2 μg/day
278744|NCT01304706|O1|Outcome|Fluocinolone Acetonide|Fluocinolone Acetonide: 0.2 μg/day
278745|NCT01304706|E1|Reported Event|Fluocinolone Acetonide|Fluocinolone Acetonide: 0.2 μg/day
278746|NCT01304693|B6|Baseline|Total|Total of all reporting groups
278747|NCT01304693|B5|Baseline|Lucentis|Single intravitreal injection with 6-month follow-up
278748|NCT01304693|B4|Baseline|ESBA1008 Dose D|Single intravitreal injection with 6-month follow-up
278749|NCT01304693|B3|Baseline|ESBA1008 Dose C|Single intravitreal injection with 6-month follow-up
278750|NCT01304693|B2|Baseline|ESBA1008 Dose B|Single intravitreal injection with 6-month follow-up
278751|NCT01304693|B1|Baseline|ESBA1008 Dose A|Single intravitreal injection with 6-month follow-up
278752|NCT01304693|P5|Participant Flow|Lucentis|Single intravitreal injection with 6-month follow-up
278753|NCT01304693|P4|Participant Flow|ESBA1008 Dose D|Single intravitreal injection with 6-month follow-up
278754|NCT01304693|P3|Participant Flow|ESBA1008 Dose C|Single intravitreal injection with 6-month follow-up
278755|NCT01304693|P2|Participant Flow|ESBA1008 Dose B|Single intravitreal injection with 6-month follow-up
278756|NCT01304693|P1|Participant Flow|ESBA1008 Dose A|Single intravitreal injection with 6-month follow-up
278757|NCT01304693|O5|Outcome|Lucentis|Single intravitreal injection with 6-month follow-up
278758|NCT01304693|O4|Outcome|ESBA1008 Dose D|Single intravitreal injection with 6-month follow-up
278759|NCT01304693|O3|Outcome|ESBA1008 Dose C|Single intravitreal injection with 6-month follow-up
278760|NCT01304693|O2|Outcome|ESBA1008 Dose B|Single intravitreal injection with 6-month follow-up
278761|NCT01304693|O1|Outcome|ESBA1008 Dose A|Single intravitreal injection with 6-month follow-up
278762|NCT01304693|O5|Outcome|Lucentis|Single intravitreal injection with 6-month follow-up
278763|NCT01304693|O4|Outcome|ESBA1008 Dose D|Single intravitreal injection with 6-month follow-up
278764|NCT01304693|O3|Outcome|ESBA1008 Dose C|Single intravitreal injection with 6-month follow-up
278765|NCT01304693|O2|Outcome|ESBA1008 Dose B|Single intravitreal injection with 6-month follow-up
278766|NCT01304693|O1|Outcome|ESBA1008 Dose A|Single intravitreal injection with 6-month follow-up
278767|NCT01304693|E5|Reported Event|Lucentis|Single intravitreal injection with 6-month follow-up
278768|NCT01304693|E4|Reported Event|ESBA1008 Dose D|Single intravitreal injection with 6-month follow-up
278769|NCT01304693|E3|Reported Event|ESBA1008 Dose C|Single intravitreal injection with 6-month follow-up
278770|NCT01304693|E2|Reported Event|ESBA1008 Dose B|Single intravitreal injection with 6-month follow-up
278771|NCT01304693|E1|Reported Event|ESBA1008 Dose A|Single intravitreal injection with 6-month follow-up
278772|NCT01304641|B3|Baseline|Total|Total of all reporting groups
278773|NCT01304641|B2|Baseline|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
278774|NCT01304641|B1|Baseline|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
278775|NCT01304641|P2|Participant Flow|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
278776|NCT01304641|P1|Participant Flow|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
278777|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
278778|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
278890|NCT01304238|P2|Participant Flow|Lepirudin|Participants treated with lepirudin after HIT II
278782|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
278783|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
278784|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
278785|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
278786|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
278787|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
278788|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
278789|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
278790|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
278791|NCT01304641|E2|Reported Event|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
278792|NCT01304641|E1|Reported Event|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
278793|NCT01304589|B1|Baseline|Milnacipram|Open-label study of milnacipram. 50 to 200 milligrams orally per day. Tablets were taken in the morning during an 18-week clinical trial.
278794|NCT01304589|P1|Participant Flow|Milnacipran|Milnacipran: 6-week titration period starting at 12.5mg daily and moving up to 200mg daily (or maximum tolerated dose)for 12 weeks - total treatment period is 18 weeks
278795|NCT01304589|O1|Outcome|Milnacipram|Crossover study
278796|NCT01304589|O1|Outcome|Milnacipram|Crossover study
278797|NCT01304589|O1|Outcome|Milnacipran|Milnacipran: 6-week titration period starting at 12.5mg daily and moving up to 200mg daily (or maximum tolerated dose)for 12 weeks - total treatment period is 18 weeks
278798|NCT01304589|O1|Outcome|Milnacipram|open-label study
278799|NCT01304589|E1|Reported Event|Milnacipram|Crossover study
278800|NCT01304498|B3|Baseline|Total|Total of all reporting groups
278801|NCT01304498|B2|Baseline|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
278802|NCT01304498|B1|Baseline|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
278803|NCT01304498|P2|Participant Flow|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
278804|NCT01304498|P1|Participant Flow|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
278805|NCT01304498|O2|Outcome|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
278806|NCT01304498|O1|Outcome|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
278807|NCT01304498|O2|Outcome|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
278808|NCT01304498|O1|Outcome|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
278809|NCT01304498|O2|Outcome|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
278810|NCT01304498|O1|Outcome|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
278811|NCT01304498|O2|Outcome|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
278812|NCT01304498|O1|Outcome|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
278813|NCT01304498|O2|Outcome|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
278814|NCT01304498|O1|Outcome|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
278815|NCT01304498|O2|Outcome|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
278816|NCT01304498|O1|Outcome|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
278817|NCT01304498|O2|Outcome|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
278818|NCT01304498|O1|Outcome|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
278819|NCT01304498|O2|Outcome|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
278820|NCT01304498|O1|Outcome|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
278821|NCT01304498|E2|Reported Event|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
278822|NCT01304498|E1|Reported Event|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
278823|NCT01304329|B1|Baseline|Study Overall|This was a randomised, 3-period, crossover trial. The trial was open label. The three treatments were separated by a washout period of at least 7 days.
278824|NCT01304329|P6|Participant Flow|Empa Plus Sim / Simvastatin Alone / Empa Alone|"Patients were administered three treatments in the following order:~A single dose of empagliflozin 25mg together with 40mg simvastatin~A single dose of simvastatin 40mg~A single dose of empagliflozin 25mg"
278825|NCT01304329|P5|Participant Flow|Empa Plus Sim / Empa Alone / Simvastatin Alone|"Patients were administered three treatments in the following order:~A single dose of empagliflozin 25mg together with 40mg simvastatin~A single dose of empagliflozin 25mg~A single dose of simvastatin 40mg"
278826|NCT01304329|P4|Participant Flow|Simvastatin Alone / Empa Plus Sim / Empa Alone|"Patients were administered three treatments in the following order:~A single dose of simvastatin 40mg~A single dose of empagliflozin 25mg together with 40mg simvastatin~A single dose of empagliflozin 25mg"
278827|NCT01304329|P3|Participant Flow|Simvastatin Alone / Empa Alone / Empa Plus Sim|"Patients were administered three treatments in the following order:~A single dose of simvastatin 40mg~A single dose of empagliflozin 25mg~A single dose of empagliflozin 25mg together with 40mg simvastatin"
278828|NCT01304329|P2|Participant Flow|Empa Alone / Empa Plus Sim / Simvastatin Alone|"Patients were administered three treatments in the following order:~A single dose of empagliflozin 25mg~A single dose of empagliflozin 25mg together with 40mg simvastatin~A single dose of simvastatin 40mg"
278829|NCT01304329|P1|Participant Flow|Empa Alone / Simvastatin Alone / Empa Plus Sim|"Patients were administered three treatments in the following order:~A single dose of empagliflozin 25mg~A single dose of simvastatin 40mg~A single dose of empagliflozin 25mg together with 40mg simvastatin"
278830|NCT01304329|O2|Outcome|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
278831|NCT01304329|O1|Outcome|Simvastatin Alone|40 mg simvastatin alone
278832|NCT01304329|O2|Outcome|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
278833|NCT01304329|O1|Outcome|Empa Alone|25mg empagliflozin (empa) alone
278834|NCT01304329|O2|Outcome|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
278835|NCT01304329|O1|Outcome|Simvastatin Alone|40 mg simvastatin alone
278836|NCT01304329|O2|Outcome|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
278837|NCT01304329|O1|Outcome|Empa Alone|25mg empagliflozin (empa) alone
278838|NCT01304329|O2|Outcome|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
278839|NCT01304329|O1|Outcome|Simvastatin Alone|40 mg simvastatin alone
278840|NCT01304329|O2|Outcome|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
278841|NCT01304329|O1|Outcome|Empa Alone|25mg empagliflozin (empa) alone
278842|NCT01304329|E3|Reported Event|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
278843|NCT01304329|E2|Reported Event|Simvastatin Alone|40 mg simvastatin alone
278844|NCT01304329|E1|Reported Event|Empa Alone|25mg empagliflozin (empa) alone
278845|NCT01304316|B1|Baseline|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
278846|NCT01304316|P1|Participant Flow|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
278847|NCT01304316|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
278848|NCT01304316|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
278849|NCT01304316|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
278850|NCT01304316|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
278851|NCT01304316|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
278852|NCT01304316|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
278891|NCT01304238|P1|Participant Flow|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
314128|NCT01211145|O1|Outcome|Placebo|Placebo to ZOMIG nasal spray
278853|NCT01304316|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
278854|NCT01304316|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
278855|NCT01304316|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
278856|NCT01304316|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
278857|NCT01304316|E2|Reported Event|High K305 Dose|Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl
278858|NCT01304316|E1|Reported Event|Standard K305 Dose|Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl
278859|NCT01304277|B1|Baseline|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
278860|NCT01304277|P1|Participant Flow|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
278861|NCT01304277|O3|Outcome|Overall|Overall number of patients who experienced adverse events during the course of REP-082 study.
278862|NCT01304277|O2|Outcome|Replagal AF|Patients received 7 EOW infusions of treatment with Replagal AF from week 2 to week 14 in REP-082.
278863|NCT01304277|O1|Outcome|Replagal RB|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082.
278864|NCT01304277|O1|Outcome|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
278865|NCT01304277|O1|Outcome|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
278866|NCT01304277|O1|Outcome|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
278867|NCT01304277|O1|Outcome|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
278868|NCT01304277|O1|Outcome|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
278869|NCT01304277|O1|Outcome|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
278870|NCT01304277|E1|Reported Event|Replagal® (0.2 mg/kg, IV, EOW)|Overall patients that participated in REP-082
278871|NCT01304238|B11|Baseline|Total|Total of all reporting groups
278872|NCT01304238|B10|Baseline|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
278873|NCT01304238|B9|Baseline|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
278874|NCT01304238|B8|Baseline|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
278875|NCT01304238|B7|Baseline|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
278876|NCT01304238|B6|Baseline|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
278877|NCT01304238|B5|Baseline|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
278878|NCT01304238|B4|Baseline|Fondaparinux|Participants treated with fondaparinux after HIT II
278879|NCT01304238|B3|Baseline|Danaparoid|Participants treated with danaparoid after HIT II
278880|NCT01304238|B2|Baseline|Lepirudin|Participants treated with lepirudin after HIT II
278881|NCT01304238|B1|Baseline|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
278882|NCT01304238|P10|Participant Flow|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
278883|NCT01304238|P9|Participant Flow|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
278884|NCT01304238|P8|Participant Flow|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
278885|NCT01304238|P7|Participant Flow|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
278886|NCT01304238|P6|Participant Flow|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
278887|NCT01304238|P5|Participant Flow|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
278888|NCT01304238|P4|Participant Flow|Fondaparinux|Participants treated with fondaparinux after HIT II
278889|NCT01304238|P3|Participant Flow|Danaparoid|Participants treated with danaparoid after HIT II
314129|NCT01211145|O4|Outcome|ZOMIG 5 mg|ZOMIG nasal spray
278892|NCT01304238|O10|Outcome|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
278893|NCT01304238|O9|Outcome|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
278894|NCT01304238|O8|Outcome|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
278895|NCT01304238|O7|Outcome|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
278896|NCT01304238|O6|Outcome|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
278897|NCT01304238|O5|Outcome|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
278898|NCT01304238|O4|Outcome|Fondaparinux|Participants treated with fondaparinux after HIT II
278899|NCT01304238|O3|Outcome|Danaparoid|Participants treated with danaparoid after HIT II
278900|NCT01304238|O2|Outcome|Lepirudin|Participants treated with lepirudin after HIT II
278901|NCT01304238|O1|Outcome|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
278902|NCT01304238|O10|Outcome|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
278903|NCT01304238|O9|Outcome|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
278904|NCT01304238|O8|Outcome|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
278905|NCT01304238|O7|Outcome|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
278906|NCT01304238|O6|Outcome|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
278907|NCT01304238|O5|Outcome|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
278908|NCT01304238|O4|Outcome|Fondaparinux|Participants treated with fondaparinux after HIT II
278909|NCT01304238|O3|Outcome|Danaparoid|Participants treated with danaparoid after HIT II
278910|NCT01304238|O2|Outcome|Lepirudin|Participants treated with lepirudin after HIT II
278911|NCT01304238|O1|Outcome|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
278912|NCT01304238|O10|Outcome|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
278913|NCT01304238|O9|Outcome|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
278914|NCT01304238|O8|Outcome|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
278915|NCT01304238|O7|Outcome|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
278916|NCT01304238|O6|Outcome|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
278917|NCT01304238|O5|Outcome|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
278918|NCT01304238|O4|Outcome|Fondaparinux|Participants treated with fondaparinux after HIT II
278919|NCT01304238|O3|Outcome|Danaparoid|Participants treated with danaparoid after HIT II
278920|NCT01304238|O2|Outcome|Lepirudin|Participants treated with lepirudin after HIT II
278921|NCT01304238|O1|Outcome|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
278922|NCT01304238|O10|Outcome|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
278923|NCT01304238|O9|Outcome|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
278924|NCT01304238|O8|Outcome|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
278925|NCT01304238|O7|Outcome|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
278926|NCT01304238|O6|Outcome|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
278927|NCT01304238|O5|Outcome|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
278928|NCT01304238|O4|Outcome|Fondaparinux|Participants treated with fondaparinux after HIT II
278929|NCT01304238|O3|Outcome|Danaparoid|Participants treated with danaparoid after HIT II
278930|NCT01304238|O2|Outcome|Lepirudin|Participants treated with lepirudin after HIT II
278931|NCT01304238|O1|Outcome|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
278932|NCT01304238|O10|Outcome|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
278933|NCT01304238|O9|Outcome|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
278934|NCT01304238|O8|Outcome|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
278935|NCT01304238|O7|Outcome|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
278936|NCT01304238|O6|Outcome|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
278937|NCT01304238|O5|Outcome|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
278938|NCT01304238|O4|Outcome|Fondaparinux|Participants treated with fondaparinux after HIT II
278939|NCT01304238|O3|Outcome|Danaparoid|Participants treated with danaparoid after HIT II
278940|NCT01304238|O2|Outcome|Lepirudin|Participants treated with lepirudin after HIT II
278941|NCT01304238|O1|Outcome|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
278942|NCT01304238|O10|Outcome|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
278943|NCT01304238|O9|Outcome|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
278944|NCT01304238|O8|Outcome|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
278945|NCT01304238|O7|Outcome|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
278946|NCT01304238|O6|Outcome|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
278947|NCT01304238|O5|Outcome|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
278951|NCT01304238|O1|Outcome|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
278952|NCT01304238|E10|Reported Event|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
278953|NCT01304238|E9|Reported Event|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
278954|NCT01304238|E8|Reported Event|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
278955|NCT01304238|E7|Reported Event|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
278956|NCT01304238|E6|Reported Event|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
278957|NCT01304238|E5|Reported Event|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
278958|NCT01304238|E4|Reported Event|Fondaparinux|Participants treated with fondaparinux after HIT II
278959|NCT01304238|E3|Reported Event|Danaparoid|Participants treated with danaparoid after HIT II
278960|NCT01304238|E2|Reported Event|Lepirudin|Participants treated with lepirudin after HIT II
278961|NCT01304238|E1|Reported Event|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
278962|NCT01304147|B1|Baseline|Participants Treated|
278963|NCT01304147|P2|Participant Flow|Placebo, Then Ketamine|placebo: Single dose of saline (0.9% saline solution) intranasal for 7 days in first intervention, then Ketamine 50mg in second intervention.
278964|NCT01304147|P1|Participant Flow|Ketamine Then Placebo|Ketamine: A single dose of intranasal ketamine up to 50 mg for 7 days in first intervention. Then Placebo for 7 days in 2nd intervention.
278965|NCT01304147|O2|Outcome|Placebo|placebo: Single dose of saline intranasal
278966|NCT01304147|O1|Outcome|Ketamine|Ketamine: A single dose of intranasal ketamine up to 50 mg
278967|NCT01304147|O2|Outcome|Placebo|placebo: Single dose of saline intranasal
278968|NCT01304147|O1|Outcome|Ketamine|Ketamine: A single dose of intranasal ketamine up to 50 mg
278969|NCT01304147|E2|Reported Event|Placebo|
278970|NCT01304147|E1|Reported Event|Ketamine|
278971|NCT01304082|B1|Baseline|All Study Participants|All study participants
278972|NCT01304082|P5|Participant Flow|A, L, C|alkalinized lidocaine, lidocaine, control
278973|NCT01304082|P4|Participant Flow|A, C, L|alkalinized lidocaine, control, lidocaine
278974|NCT01304082|P3|Participant Flow|L, C, A|lidocaine, control, alkalinized lidocaine
278975|NCT01304082|P2|Participant Flow|C, A, L|control, alkalinized lidocaine, lidocaine
278976|NCT01304082|P1|Participant Flow|C, L, A|control, lidocaine, alkalinized lidocaine
278977|NCT01304082|O3|Outcome|Alkalinized Lidocaine|alkalinized lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate
278978|NCT01304082|O2|Outcome|Lidocaine|Lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine, given once
278979|NCT01304082|O1|Outcome|Normal Saline|normal saline: 1 ml subcutaneous injection 0.9% sodium chloride, given once
278980|NCT01304082|O3|Outcome|Alkalinized Lidocaine|alkalinized lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate
278981|NCT01304082|O2|Outcome|Lidocaine|Lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine, given once
278982|NCT01304082|O1|Outcome|Normal Saline|normal saline: 1 ml subcutaneous injection 0.9% sodium chloride, given once
278983|NCT01304082|O3|Outcome|Alkalinized Lidocaine|alkalinized lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate
278984|NCT01304082|O2|Outcome|Lidocaine|Lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine, given once
278985|NCT01304082|O1|Outcome|Normal Saline|normal saline: 1 ml subcutaneous injection 0.9% sodium chloride, given once
278986|NCT01304082|O3|Outcome|Alkalinized Lidocaine|alkalinized lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate
278987|NCT01304082|O2|Outcome|Lidocaine|Lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine, given once
278988|NCT01304082|O1|Outcome|Normal Saline|normal saline: 1 ml subcutaneous injection 0.9% sodium chloride, given once
278989|NCT01304082|E3|Reported Event|Alkalinized Lidocaine|1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate
278990|NCT01304082|E2|Reported Event|Lidocaine|1 ml subcutaneous injection of 0.9% lidocaine, given once
278991|NCT01304082|E1|Reported Event|Normal Saline|1 ml subcutaneous injection 0.9% sodium chloride, given once
278992|NCT01303861|B6|Baseline|Total|Total of all reporting groups
278993|NCT01303861|B5|Baseline|Dropped Prior to Condition Assignment|These subjects discontinued study participation prior to being assigned to a condition.
278994|NCT01303861|B4|Baseline|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.~Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
279012|NCT01303861|O2|Outcome|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week"
279181|NCT01303224|E3|Reported Event|Ibodutant 10 mg|oral tablet, once daily
278995|NCT01303861|B3|Baseline|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week~Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
278996|NCT01303861|B2|Baseline|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline carbon monoxide (CO): 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week"
278997|NCT01303861|B1|Baseline|Varenicline|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
278998|NCT01303861|P4|Participant Flow|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.~Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
278999|NCT01303861|P3|Participant Flow|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week~Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
279000|NCT01303861|P2|Participant Flow|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week"
279001|NCT01303861|P1|Participant Flow|Varenicline|"This group will consist of smokers who, based on smoking behavior, Do NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
279002|NCT01303861|O4|Outcome|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.~Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
279013|NCT01303861|O1|Outcome|Varenicline|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
279014|NCT01303861|E5|Reported Event|Dropped Prior to Condition Assignment|These subjects discontinued study participation prior to being assigned to a condition.
279182|NCT01303224|E2|Reported Event|Ibodutant 3 mg|oral tablet, once daily
279003|NCT01303861|O3|Outcome|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week~Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
279004|NCT01303861|O2|Outcome|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week"
279005|NCT01303861|O1|Outcome|Varenicline|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
279006|NCT01303861|O4|Outcome|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.~Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
279007|NCT01303861|O3|Outcome|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week~Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
279008|NCT01303861|O2|Outcome|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week"
279009|NCT01303861|O1|Outcome|Varenicline|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
279010|NCT01303861|O4|Outcome|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.~Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
279011|NCT01303861|O3|Outcome|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week~Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
279015|NCT01303861|E4|Reported Event|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.~Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
279016|NCT01303861|E3|Reported Event|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week~Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
279017|NCT01303861|E2|Reported Event|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week"
279018|NCT01303861|E1|Reported Event|Varenicline|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
279019|NCT01303835|B3|Baseline|Total|Total of all reporting groups
279020|NCT01303835|B2|Baseline|Placebo|Randomized patients received placebo to be taken every night before bed.
279021|NCT01303835|B1|Baseline|Naltrexone|Randomized patients received 4.5 mg naltrexone to be taken every night before bed.
279022|NCT01303835|P2|Participant Flow|Placebo|Randomized patients received placebo to be taken every night before bed.
279023|NCT01303835|P1|Participant Flow|Naltrexone|Randomized patients received 4.5 mg naltrexone to be taken every night before bed.
279024|NCT01303835|O2|Outcome|Placebo|Randomized patients received placebo to be taken every night before bed.
279025|NCT01303835|O1|Outcome|Low Dose Naltrexone (LDN)|Randomized patients received 4.5 mg naltrexone to be taken every night before bed.
279026|NCT01303835|O2|Outcome|Placebo|Randomized patients received placebo to be taken every night before bed.
279027|NCT01303835|O1|Outcome|Low Dose Naltrexone (LDN)|Randomized patients received 4.5 mg naltrexone to be taken every night before bed.
279028|NCT01303835|O2|Outcome|Placebo|Randomized patients received placebo to be taken every night before bed.
279029|NCT01303835|O1|Outcome|Low Dose Naltrexone (LDN)|Randomized patients received 4.5 mg naltrexone to be taken every night before bed.
279030|NCT01303835|E2|Reported Event|Placebo|Randomized patients received placebo to be taken every night before bed.
279031|NCT01303835|E1|Reported Event|Naltrexone|Randomized patients received 4.5 mg low dose naltrexone (LDN) to be taken every night before bed.
279032|NCT01303744|B5|Baseline|Total|Total of all reporting groups
279033|NCT01303744|B4|Baseline|Placebo|"placebo, oral tablet, multidose~Placebo: oral tablet, once a day in the morning for 12 weeks"
279034|NCT01303744|B3|Baseline|CHF 5074 3x|"oral tablet, multidose~CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
279035|NCT01303744|B2|Baseline|CHF 5074 2x|"oral tablet, multidose~CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
279036|NCT01303744|B1|Baseline|CHF 5074 1x|"oral tablet, multidose~CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
279037|NCT01303744|P4|Participant Flow|Placebo|"placebo, oral tablet, multidose~Placebo: oral tablet, once a day in the morning for 12 weeks"
279038|NCT01303744|P3|Participant Flow|CHF 5074 3x|"oral tablet, multidose~CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
279039|NCT01303744|P2|Participant Flow|CHF 5074 2x|"oral tablet, multidose~CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
279040|NCT01303744|P1|Participant Flow|CHF 5074 1x|"oral tablet, multidose~CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
279041|NCT01303744|O4|Outcome|Placebo|"placebo, oral tablet, multidose~Placebo: oral tablet, once a day in the morning for 12 weeks"
279042|NCT01303744|O3|Outcome|CHF 5074 3x|"oral tablet, multidose~CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
279043|NCT01303744|O2|Outcome|CHF 5074 2x|"oral tablet, multidose~CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
279044|NCT01303744|O1|Outcome|CHF 5074 1x|"oral tablet, multidose~CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
279045|NCT01303744|O4|Outcome|Placebo|"placebo, oral tablet, multidose~Placebo: oral tablet, once a day in the morning for 12 weeks"
279046|NCT01303744|O3|Outcome|CHF 5074 3x|"oral tablet, multidose~CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
279047|NCT01303744|O2|Outcome|CHF 5074 2x|"oral tablet, multidose~CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
279048|NCT01303744|O1|Outcome|CHF 5074 1x|"oral tablet, multidose~CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
279049|NCT01303744|O4|Outcome|Placebo|"placebo, oral tablet, multidose~Placebo: oral tablet, once a day in the morning for 12 weeks"
279050|NCT01303744|O3|Outcome|CHF 5074 3x|"oral tablet, multidose~CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
279051|NCT01303744|O2|Outcome|CHF 5074 2x|"oral tablet, multidose~CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
279052|NCT01303744|O1|Outcome|CHF 5074 1x|"oral tablet, multidose~CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
279053|NCT01303744|E4|Reported Event|Placebo|"placebo, oral tablet, multidose~Placebo: oral tablet, once a day in the morning for 12 weeks"
279054|NCT01303744|E3|Reported Event|CHF 5074 3x|"oral tablet, multidose~CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
279055|NCT01303744|E2|Reported Event|CHF 5074 2x|"oral tablet, multidose~CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
279056|NCT01303744|E1|Reported Event|CHF 5074 1x|"oral tablet, multidose~CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
279057|NCT01303627|B3|Baseline|Total|Total of all reporting groups
279058|NCT01303627|B2|Baseline|Control|Control:Remifentanil stopped at the end of the surgery
279059|NCT01303627|B1|Baseline|Ultiva,Remifentanil,Opioid,Analgesic|Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery
279060|NCT01303627|P2|Participant Flow|Control|Control:Remifentanil stopped at the end of the surgery
279061|NCT01303627|P1|Participant Flow|Ultiva,Remifentanil,Opioid,Analgesic|Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery
279062|NCT01303627|O2|Outcome|Control Group|Remifentanil stopped at the and of the surgery
279063|NCT01303627|O1|Outcome|Remifentanil Group|remifentanil group (group R) TCI effect-site of remifentanil at 1.5 ng/ml was continued until cLMA removal
279064|NCT01303627|E2|Reported Event|Control Group|Remifentanil stopped at the end of the surgery
279065|NCT01303627|E1|Reported Event|Remifentanil Group|remifentanil group (group R) TCI effect-site of remifentanil at 1.5 ng/ml was continued until cLMA removal
279066|NCT01303510|B3|Baseline|Total|Total of all reporting groups
279067|NCT01303510|B2|Baseline|Group B|Elderly subjects aged over 60 years
279068|NCT01303510|B1|Baseline|Group A|Adults from 18 to 60 years old inclusive
279069|NCT01303510|P2|Participant Flow|Group B|Elderly subjects aged over 60 years
279070|NCT01303510|P1|Participant Flow|Group A|Adults from 18 to 60 years old inclusive
279071|NCT01303510|O2|Outcome|Group B|Elderly subjects aged over 60 years
279072|NCT01303510|O1|Outcome|Group A|Adults from 18 to 60 years old inclusive
279073|NCT01303510|O2|Outcome|Group B|Elderly subjects aged over 60 years
279074|NCT01303510|O1|Outcome|Group A|Adults from 18 to 60 years old inclusive
279075|NCT01303510|O2|Outcome|Group B|Elderly subjects aged over 60 years
279076|NCT01303510|O1|Outcome|Group A|Adults from 18 to 60 years old inclusive
279077|NCT01303510|O2|Outcome|Group B|Elderly subjects aged over 60 years
279078|NCT01303510|O1|Outcome|Group A|Adults from 18 to 60 years old inclusive
279079|NCT01303510|O2|Outcome|Group B|Elderly subjects aged over 60 years
279080|NCT01303510|O1|Outcome|Group A|Adults from 18 to 60 years old inclusive
279081|NCT01303510|E2|Reported Event|Group B|Elderly subjects aged over 60 years
279082|NCT01303510|E1|Reported Event|Group A|Adults from 18 to 60 years old inclusive
279083|NCT01303445|B1|Baseline|Entire Study Population|
279084|NCT01303445|P2|Participant Flow|CDAB Sequence|Omeprazole/Aggrenox+Omeprazole/Aggrenox/Aggrenox+Omeprazole
279085|NCT01303445|P1|Participant Flow|ABCD Sequence|Aggrenox/Aggrenox+Omeprazole/Omeprazole/Aggrenox+Omeprazole
279086|NCT01303445|O4|Outcome|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
279087|NCT01303445|O3|Outcome|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
279088|NCT01303445|O2|Outcome|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
279089|NCT01303445|O1|Outcome|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
279090|NCT01303445|O4|Outcome|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
279091|NCT01303445|O3|Outcome|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
279092|NCT01303445|O2|Outcome|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
279093|NCT01303445|O1|Outcome|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
279094|NCT01303445|O4|Outcome|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
279095|NCT01303445|O3|Outcome|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
279161|NCT01303224|O3|Outcome|Ibodutant 10 mg|oral tablet, once daily
279162|NCT01303224|O2|Outcome|Ibodutant 3 mg|oral tablet, once daily
279096|NCT01303445|O2|Outcome|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
279097|NCT01303445|O1|Outcome|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
279098|NCT01303445|O4|Outcome|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
279099|NCT01303445|O3|Outcome|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
279100|NCT01303445|O2|Outcome|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
279101|NCT01303445|O1|Outcome|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
279102|NCT01303445|O4|Outcome|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
279103|NCT01303445|O3|Outcome|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
279104|NCT01303445|O2|Outcome|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
279105|NCT01303445|O1|Outcome|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
279106|NCT01303445|O4|Outcome|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
279107|NCT01303445|O3|Outcome|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
279108|NCT01303445|O2|Outcome|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
279109|NCT01303445|O1|Outcome|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
279110|NCT01303445|E4|Reported Event|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
279111|NCT01303445|E3|Reported Event|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
279112|NCT01303445|E2|Reported Event|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
279113|NCT01303445|E1|Reported Event|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
279114|NCT01303406|B3|Baseline|Total|Total of all reporting groups
279115|NCT01303406|B2|Baseline|Idebenone|"Following the body weight, patients will be allocated to one of the following regimen:~Idebenone Patients < 45 kg - 3 tablets 3 times a day with meals~Idebenone Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
279116|NCT01303406|B1|Baseline|Placebo|"Following the body weight, patients will be allocated to one of the following regimen:~Placebo Patients < 45 kg - 3 tablets 3 times a day with meals~Placebo Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
279117|NCT01303406|P2|Participant Flow|Idebenone|"Following the body weight, patients will be allocated to one of the following regimen:~Idebenone Patients < 45 kg - 3 tablets 3 times a day with meals~Idebenone Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
279118|NCT01303406|P1|Participant Flow|Placebo|"Following the body weight, patients will be allocated to one of the following regimen:~Placebo Patients < 45 kg - 3 tablets 3 times a day with meals~Placebo Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
279119|NCT01303406|O2|Outcome|Idebenone|"Following the body weight, patients will be allocated to one of the following regimen:~Idebenone Patients < 45 kg - 3 tablets 3 times a day with meals~Idebenone Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
279120|NCT01303406|O1|Outcome|Placebo|"Following the body weight, patients will be allocated to one of the following regimen:~Placebo Patients < 45 kg - 3 tablets 3 times a day with meals~Placebo Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
279121|NCT01303406|O2|Outcome|Idebenone|"Following the body weight, patients will be allocated to one of the following regimen:~Idebenone Patients < 45 kg - 3 tablets 3 times a day with meals~Idebenone Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
279163|NCT01303224|O1|Outcome|Ibodutant 1 mg|oral tablet, once daily
279164|NCT01303224|O4|Outcome|Placebo|oral tablet, once daily
279165|NCT01303224|O3|Outcome|Ibodutant 10 mg|oral tablet, once daily
279122|NCT01303406|O1|Outcome|Placebo|"Following the body weight, patients will be allocated to one of the following regimen:~Placebo Patients < 45 kg - 3 tablets 3 times a day with meals~Placebo Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
279123|NCT01303406|E2|Reported Event|Idebenone|"Following the body weight, patients will be allocated to one of the following regimen:~Idebenone Patients < 45 kg - 3 tablets 3 times a day with meals~Idebenone Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
279124|NCT01303406|E1|Reported Event|Placebo|"Following the body weight, patients will be allocated to one of the following regimen:~Placebo Patients < 45 kg - 3 tablets 3 times a day with meals~Placebo Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
279125|NCT01303380|B1|Baseline|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
279126|NCT01303380|P1|Participant Flow|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new Hyper-IgD with periodic fever syndrome (HIDS) flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
279127|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
279128|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
279129|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
279130|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
279131|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
279166|NCT01303224|O2|Outcome|Ibodutant 3 mg|oral tablet, once daily
279167|NCT01303224|O1|Outcome|Ibodutant 1 mg|oral tablet, once daily
279168|NCT01303224|O4|Outcome|Placebo|oral tablet, once daily
279169|NCT01303224|O3|Outcome|Ibodutant 10 mg|oral tablet, once daily
279170|NCT01303224|O2|Outcome|Ibodutant 3 mg|oral tablet, once daily
279171|NCT01303224|O1|Outcome|Ibodutant 1 mg|oral tablet, once daily
279132|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
279133|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
279134|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
279135|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
279136|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
279137|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
279138|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
279139|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
279140|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
279141|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
279172|NCT01303224|O4|Outcome|Placebo|oral tablet, once daily
279173|NCT01303224|O3|Outcome|Ibodutant 10 mg|oral tablet, once daily
279142|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
279143|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
279144|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
279145|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
279146|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
279147|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
279148|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
279149|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
279150|NCT01303380|E1|Reported Event|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator’s discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
279151|NCT01303224|B5|Baseline|Total|Total of all reporting groups
279152|NCT01303224|B4|Baseline|Placebo|oral tablet, once daily
279153|NCT01303224|B3|Baseline|Ibodutant 10 mg|oral tablet, once daily
279154|NCT01303224|B2|Baseline|Ibodutant 3 mg|oral tablet, once daily
279155|NCT01303224|B1|Baseline|Ibodutant 1 mg|oral tablet, once daily
279156|NCT01303224|P4|Participant Flow|Placebo|oral tablet, once daily
279157|NCT01303224|P3|Participant Flow|Ibodutant 10 mg|oral tablet, once daily
279158|NCT01303224|P2|Participant Flow|Ibodutant 3 mg|oral tablet, once daily
279159|NCT01303224|P1|Participant Flow|Ibodutant 1 mg|oral tablet, once daily
279160|NCT01303224|O4|Outcome|Placebo|oral tablet, once daily
279183|NCT01303224|E1|Reported Event|Ibodutant 1 mg|oral tablet, once daily
279184|NCT01303159|B1|Baseline|Radiofrequency Probe (ENDOHPB)|Intervention: The EndoHPB Radiofrequency probe
279185|NCT01303159|P1|Participant Flow|Radiofrequency Probe (ENDOHPB)|"Intervention:~The EndoHPB Radiofrequency probe"
279186|NCT01303159|O1|Outcome|Radiofrequency Probe (ENDOHPB)|"Intervention:~The EndoHPB Radiofrequency probe"
279187|NCT01303159|O1|Outcome|Radiofrequency Probe (ENDOHPB)|"Intervention:~The EndoHPB Radiofrequency probe"
279188|NCT01303159|E1|Reported Event|Radiofrequency Probe (ENDOHPB)|"Intervention:~The EndoHPB Radiofrequency probe"
279189|NCT01302938|B3|Baseline|Total|Total of all reporting groups
279190|NCT01302938|B2|Baseline|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
279191|NCT01302938|B1|Baseline|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
279192|NCT01302938|P2|Participant Flow|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
279193|NCT01302938|P1|Participant Flow|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
279194|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
279195|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
279196|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
279197|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
279198|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
279199|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
279200|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
279201|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
279202|NCT01302938|O1|Outcome|Entire Study Population|Includes all participants who received either tolterodine 4 mg extended release capsule once daily or matching placebo for 12 weeks.
279203|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
279204|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
279205|NCT01302938|O1|Outcome|Entire Study Population|Includes all participants who received either tolterodine 4 mg extended release capsule once daily or matching placebo for 12 weeks.
279206|NCT01302938|O1|Outcome|Entire Study Population|Includes all participants who received either tolterodine 4 mg extended release capsule once daily or matching placebo for 12 weeks.
279207|NCT01302938|O1|Outcome|Entire Study Population|Includes all participants who received either tolterodine 4 mg extended release capsule once daily or matching placebo for 12 weeks.
279208|NCT01302938|O1|Outcome|Entire Study Population|Includes all participants who received either tolterodine 4 mg extended release capsule once daily or matching placebo for 12 weeks.
279209|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
279210|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
279211|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
279212|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
279213|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
279214|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
279215|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
279216|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
279217|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
279218|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
279219|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
279220|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
279221|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
279222|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
279223|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
279224|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
279225|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
279226|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
279227|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
279228|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
279229|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
279230|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
279231|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
279232|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
279233|NCT01302938|E2|Reported Event|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
279234|NCT01302938|E1|Reported Event|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
279235|NCT01302899|B3|Baseline|Total|Total of all reporting groups
314130|NCT01211145|O3|Outcome|ZOMIG 2.5 mg|ZOMIG nasal spray
279236|NCT01302899|B2|Baseline|Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram|"Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.~Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule placebo to HCTZ 25 mg o.d.~Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule HCTZ 25 mg o.d.~Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d."
279237|NCT01302899|B1|Baseline|Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram|"Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.~Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule HCTZ 25 mg o.d.~Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.~Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d."
279238|NCT01302899|P2|Participant Flow|Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram|"Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.~Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule placebo to HCTZ 25 mg o.d.~Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule HCTZ 25 mg o.d.~Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d."
279239|NCT01302899|P1|Participant Flow|Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram|"Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.~Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule HCTZ 25 mg o.d.~Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.~Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d."
279240|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
279241|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
279242|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
279243|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
279244|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
279245|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
279246|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
279247|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
279248|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
279249|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
279250|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
279251|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
279252|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
279253|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
279254|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
279255|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
279256|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
279257|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
279258|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
279259|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
279260|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
279261|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
279262|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
279263|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
279264|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
279265|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
279266|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
279267|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
279268|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
279269|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
279270|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
279271|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
279272|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
279273|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
279274|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
279275|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
279276|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
279277|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
279278|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
279279|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
279280|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
279281|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
279364|NCT01302483|O1|Outcome|Kovacaine Nasal Spray|Number of subjects able to complete the dental procedure without rescue
279282|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
279283|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
279284|NCT01302899|E4|Reported Event|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
279285|NCT01302899|E3|Reported Event|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
279286|NCT01302899|E2|Reported Event|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
279287|NCT01302899|E1|Reported Event|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
279288|NCT01302860|B1|Baseline|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
279289|NCT01302860|P1|Participant Flow|Canakinumab|Participants received body weight stratified dose of canakinumab 2 milligrams/kilogram (mg/kg) subcutaneous (s.c.) injection every 8 weeks.
279290|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
279291|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
279292|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
279293|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
279294|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
279295|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
279296|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
279297|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
279298|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
279299|NCT01302860|E1|Reported Event|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
279300|NCT01302743|B4|Baseline|Total|Total of all reporting groups
279301|NCT01302743|B3|Baseline|Cinnulin PF|"Cinnulin PF 500 mg once a day for 90 days~Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days."
279302|NCT01302743|B2|Baseline|Cinnamon Bark|"Cinnamon Bark 1000 mg once a day for 90 days~Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days"
279303|NCT01302743|B1|Baseline|Metformin|"oral extended-release Metformin 1000 mg once a day for 90 days~Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days"
279304|NCT01302743|P3|Participant Flow|Cinnulin PF|"Cinnulin PF 500 mg once a day for 90 days~Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days."
279305|NCT01302743|P2|Participant Flow|Cinnamon Bark|"Cinnamon Bark 1000 mg once a day for 90 days~Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days"
279306|NCT01302743|P1|Participant Flow|Metformin|"oral extended-release Metformin 1000 mg once a day for 90 days~Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days"
279307|NCT01302743|O3|Outcome|Cinnulin PF|"Cinnulin PF 500 mg once a day for 90 days~Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days."
279308|NCT01302743|O2|Outcome|Cinnamon Bark|"Cinnamon Bark 1000 mg once a day for 90 days~Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days"
279309|NCT01302743|O1|Outcome|Metformin|"oral extended-release Metformin 1000 mg once a day for 90 days~Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days"
279310|NCT01302743|O3|Outcome|Cinnulin PF|"Cinnulin PF 500 mg once a day for 90 days~Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days."
279311|NCT01302743|O2|Outcome|Cinnamon Bark|"Cinnamon Bark 1000 mg once a day for 90 days~Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days"
279312|NCT01302743|O1|Outcome|Metformin|"oral extended-release Metformin 1000 mg once a day for 90 days~Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days"
279313|NCT01302743|E3|Reported Event|Cinnulin PF|"Cinnulin PF 500 mg once a day for 90 days~Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days."
279314|NCT01302743|E2|Reported Event|Cinnamon Bark|"Cinnamon Bark 1000 mg once a day for 90 days~Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days"
279315|NCT01302743|E1|Reported Event|Metformin|"oral extended-release Metformin 1000 mg once a day for 90 days~Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days"
279316|NCT01302691|B3|Baseline|Total|Total of all reporting groups
279317|NCT01302691|B2|Baseline|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
279318|NCT01302691|B1|Baseline|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
279365|NCT01302483|E2|Reported Event|Lidocaine Injection|2% lidocaine HCL with 1:100,000 epinephrine
279319|NCT01302691|P2|Participant Flow|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
279320|NCT01302691|P1|Participant Flow|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
279321|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
279322|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
279323|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
279324|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
279325|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
279326|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
279327|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
279328|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
279329|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
279330|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
279331|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
279332|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
279333|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
279334|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
279335|NCT01302691|E2|Reported Event|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
279336|NCT01302691|E1|Reported Event|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
279337|NCT01302548|B3|Baseline|Total|Total of all reporting groups
279338|NCT01302548|B2|Baseline|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
279339|NCT01302548|B1|Baseline|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
279340|NCT01302548|P2|Participant Flow|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
279341|NCT01302548|P1|Participant Flow|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
279342|NCT01302548|O2|Outcome|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
279343|NCT01302548|O1|Outcome|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
279344|NCT01302548|O2|Outcome|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
279345|NCT01302548|O1|Outcome|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
279346|NCT01302548|O2|Outcome|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
279347|NCT01302548|O1|Outcome|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
279348|NCT01302548|E2|Reported Event|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
279349|NCT01302548|E1|Reported Event|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
279350|NCT01302483|B3|Baseline|Total|Total of all reporting groups
279351|NCT01302483|B2|Baseline|Lidocaine Injection|
279352|NCT01302483|B1|Baseline|Kovacaine Nasal Spray|
279353|NCT01302483|P2|Participant Flow|Lidocaine Injection|2% lidocaine HCL with 1:100,000 epinephrine
279354|NCT01302483|P1|Participant Flow|Kovacaine Nasal Spray|.6mL 3% tetracaine HCL with 0.05% oxymetazoline HCL
279355|NCT01302483|O2|Outcome|Lidocaine Injection|2% lidocaine HCL with 1:100,000 epinephrine
279356|NCT01302483|O1|Outcome|Kovacaine Nasal Spray|.6mL 3% tetracaine HCL with 0.05% oxymetazoline HCL
279357|NCT01302483|O2|Outcome|Lidocaine Injection|Blood Pressure Maximum Change from Baseline
279358|NCT01302483|O1|Outcome|Kovacaine Nasal Spray|Blood Pressure Maximum Change from Baseline
279359|NCT01302483|O2|Outcome|Lidocaine Injection|2% lidocaine HCL with 1:100,000 epinephrine
279360|NCT01302483|O1|Outcome|Kovacaine Nasal Spray|.6mL 3% tetracaine HCL with 0.05% oxymetazoline HCL
279361|NCT01302483|O2|Outcome|Lidocaine Injection|Duration of Soft Tissue Anesthesia
279362|NCT01302483|O1|Outcome|Kovacaine Nasal Spray|Duration of Soft Tissue Anesthesia
279363|NCT01302483|O2|Outcome|Lidocaine Injection|Number of subjects able to complete the dental procedure without rescue
279366|NCT01302483|E1|Reported Event|Kovacaine Nasal Spray|.6mL 3% tetracaine HCL with 0.05% oxymetazoline HCL
279367|NCT01302444|B3|Baseline|Total|Total of all reporting groups
279368|NCT01302444|B2|Baseline|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
279369|NCT01302444|B1|Baseline|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
279370|NCT01302444|P2|Participant Flow|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
279371|NCT01302444|P1|Participant Flow|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
279372|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
279373|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
279374|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
279375|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
279376|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
279377|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
279378|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
279379|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
279380|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
279381|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
279382|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
279383|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
279384|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
279385|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
279386|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
279387|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
279388|NCT01302444|E2|Reported Event|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
279389|NCT01302444|E1|Reported Event|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
279390|NCT01302418|B1|Baseline|Symptomatic|Individuals with signs and symptoms of an acute respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
279391|NCT01302418|P1|Participant Flow|Symptomatic|Individuals with signs and symptoms of an acute respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
279392|NCT01302418|O1|Outcome|Symptomatic|Individuals with signs and symptoms of an acute respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
279393|NCT01302418|E1|Reported Event|Symptomatic|Individuals with signs and symptoms of an acute respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
279394|NCT01302392|B3|Baseline|Total|Total of all reporting groups
279395|NCT01302392|B2|Baseline|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
279396|NCT01302392|B1|Baseline|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
279397|NCT01302392|P2|Participant Flow|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
279398|NCT01302392|P1|Participant Flow|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
279399|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
279400|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
279421|NCT01302366|O1|Outcome|Sea Cucumber Extract (TBL 12)|TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
279401|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
279402|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
279403|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
279404|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
279405|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
279406|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
279407|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
279408|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
279409|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
279410|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
279411|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
279412|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
279413|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
279414|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
279415|NCT01302392|E2|Reported Event|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
279416|NCT01302392|E1|Reported Event|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
279417|NCT01302366|B1|Baseline|Sea Cucumber Extract (TBL 12)|"TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.~TBL-12"
279418|NCT01302366|P1|Participant Flow|Sea Cucumber Extract (TBL 12)|TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
279419|NCT01302366|O1|Outcome|Sea Cucumber Extract (TBL 12)|TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
279420|NCT01302366|O1|Outcome|Sea Cucumber Extract (TBL 12)|TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
314131|NCT01211145|O2|Outcome|ZOMIG 0.5 mg|ZOMIG nasal spray
279422|NCT01302366|E1|Reported Event|Sea Cucumber Extract (TBL 12)|TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
279423|NCT01302119|B3|Baseline|Total|Total of all reporting groups
279424|NCT01302119|B2|Baseline|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
279425|NCT01302119|B1|Baseline|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
279426|NCT01302119|P2|Participant Flow|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
279427|NCT01302119|P1|Participant Flow|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
279428|NCT01302119|O2|Outcome|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
279429|NCT01302119|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
279430|NCT01302119|O2|Outcome|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
279431|NCT01302119|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
279432|NCT01302119|O2|Outcome|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
279433|NCT01302119|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
279434|NCT01302119|O2|Outcome|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
279435|NCT01302119|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
279436|NCT01302119|E2|Reported Event|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
279437|NCT01302119|E1|Reported Event|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
279438|NCT01302067|B4|Baseline|Total|Total of all reporting groups
279439|NCT01302067|B3|Baseline|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
279440|NCT01302067|B2|Baseline|Placebo|Participants received one tablet of placebo per day for 12 weeks.
279441|NCT01302067|B1|Baseline|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
279442|NCT01302067|P3|Participant Flow|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
279443|NCT01302067|P2|Participant Flow|Placebo|Participants received one tablet of placebo per day for 12 weeks.
279444|NCT01302067|P1|Participant Flow|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
279445|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
279446|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
279447|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
279448|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
279449|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
279450|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
279451|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
279452|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
279453|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
279454|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
279455|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
279456|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
279457|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
279458|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
279459|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
279460|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
279461|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
279462|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
279463|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
279464|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
279465|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
314132|NCT01211145|O1|Outcome|Placebo|Placebo to ZOMIG nasal spray
279466|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
279467|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
279468|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
279469|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
279470|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
279471|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
279472|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
279473|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
279474|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
279475|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
279476|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
279477|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
279478|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
279479|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
279480|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
279481|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
279482|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
279483|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
279484|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
279485|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
279486|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
279487|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
279488|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
279489|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
279490|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
279491|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
279492|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
279493|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
279494|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
279495|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
279496|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
279497|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
279498|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
279499|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
279500|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
279501|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
279502|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
279503|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
279504|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
279505|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
279506|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
279507|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
279508|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
279509|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
279510|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
279511|NCT01302067|E3|Reported Event|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
279512|NCT01302067|E2|Reported Event|Placebo|Participants received one tablet of placebo per day for 12 weeks.
279513|NCT01302067|E1|Reported Event|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
279514|NCT01302054|B1|Baseline|Entire Study Population|Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had <= 50 percent change in UUI episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase.
279515|NCT01302054|P3|Participant Flow|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
279516|NCT01302054|P2|Participant Flow|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
279517|NCT01302054|P1|Participant Flow|Tolterodine|Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had less than or equal to [<=] 50 percent change in urgency urinary incontinence [UUI] episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase.
279518|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
279519|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
279520|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
279521|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
279522|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
279523|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
279524|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
279525|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
279526|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
279527|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
279528|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
279529|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
279530|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
279531|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
279532|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
279533|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
279534|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
279535|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
279536|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
279537|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
279538|NCT01302054|O2|Outcome|Fesoterodine: Double-Blind Week 12|Participants who received fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
279539|NCT01302054|O1|Outcome|Fesoterodine: Double-Blind Baseline|Participants who were randomized to receive fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
279540|NCT01302054|E3|Reported Event|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
279541|NCT01302054|E2|Reported Event|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
279542|NCT01302054|E1|Reported Event|Tolterodine|Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had less than or equal to [<=] 50 percent change in urgency urinary incontinence [UUI] episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase.
279543|NCT01302041|B1|Baseline|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279544|NCT01302041|P1|Participant Flow|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279545|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279546|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279547|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279548|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279549|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279550|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279551|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279552|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279553|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279554|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279555|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279556|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279557|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279558|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279559|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279560|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279561|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279562|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279563|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279564|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279613|NCT01301833|O4|Outcome|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
314133|NCT01211145|E4|Reported Event|ZOMIG 5 mg|ZOMIG nasal spray
279565|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279566|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279567|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279568|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279569|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279570|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279571|NCT01302041|E1|Reported Event|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
279572|NCT01301963|B3|Baseline|Total|Total of all reporting groups
279573|NCT01301963|B2|Baseline|Arm II|"Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.~plerixafor: Given SC~filgrastim: Given SC"
279574|NCT01301963|B1|Baseline|Arm I|"Patients receive G-CSF SC QD on days 1-4.~filgrastim: Given SC"
279575|NCT01301963|P2|Participant Flow|Arm II: Experimental|"Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.~plerixafor: Given SC~filgrastim: Given SC"
279576|NCT01301963|P1|Participant Flow|Arm I: Control|"Patients receive G-CSF SC QD on days 1-4.~filgrastim: Given SC"
279577|NCT01301963|O2|Outcome|Arm II: Experimental|"Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.~plerixafor: Given SC~filgrastim: Given SC"
279578|NCT01301963|O1|Outcome|Arm I: Control|"Patients receive G-CSF SC QD on days 1-4.~filgrastim: Given SC"
279579|NCT01301963|O2|Outcome|Arm II: Experimental|"Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.~plerixafor: Given SC~filgrastim: Given SC"
279580|NCT01301963|O1|Outcome|Arm I: Control|"Patients receive G-CSF SC QD on days 1-4.~filgrastim: Given SC"
279581|NCT01301963|E2|Reported Event|Arm II: Experimental|"Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.~plerixafor: Given SC~filgrastim: Given SC"
279582|NCT01301963|E1|Reported Event|Arm I: Control|"Patients receive G-CSF SC QD on days 1-4.~filgrastim: Given SC"
279583|NCT01301950|B3|Baseline|Total|Total of all reporting groups
279584|NCT01301950|B2|Baseline|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
279585|NCT01301950|B1|Baseline|TruMatch® Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch® Personalized Solutions Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon
279586|NCT01301950|P2|Participant Flow|TruMatch® Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
279587|NCT01301950|P1|Participant Flow|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
279588|NCT01301950|O2|Outcome|TruMatch® Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
279589|NCT01301950|O1|Outcome|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
279614|NCT01301833|O3|Outcome|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
280073|NCT01301001|E2|Reported Event|Gabapentin|2 capsules (1200 mg) am and 3 capsules (1800) mg pm
279590|NCT01301950|O2|Outcome|TruMatch® Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
279591|NCT01301950|O1|Outcome|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
279592|NCT01301950|O2|Outcome|TruMatch® Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
279593|NCT01301950|O1|Outcome|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
279594|NCT01301950|O2|Outcome|TruMatch® Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
279595|NCT01301950|O1|Outcome|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
279596|NCT01301950|O2|Outcome|TruMatch® Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
279597|NCT01301950|O1|Outcome|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
279598|NCT01301950|E2|Reported Event|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
279599|NCT01301950|E1|Reported Event|TruMatch™ Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions Instrument: TruMatch™ Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch™ is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon
279600|NCT01301833|B5|Baseline|Total|Total of all reporting groups
279601|NCT01301833|B4|Baseline|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
279602|NCT01301833|B3|Baseline|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
279603|NCT01301833|B2|Baseline|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
279604|NCT01301833|B1|Baseline|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
279605|NCT01301833|P4|Participant Flow|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
279606|NCT01301833|P3|Participant Flow|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
279607|NCT01301833|P2|Participant Flow|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
279608|NCT01301833|P1|Participant Flow|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
279609|NCT01301833|O4|Outcome|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
279610|NCT01301833|O3|Outcome|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
279611|NCT01301833|O2|Outcome|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
279612|NCT01301833|O1|Outcome|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
279940|NCT01301274|E1|Reported Event|Hypotonic|Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.
279615|NCT01301833|O2|Outcome|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
279616|NCT01301833|O1|Outcome|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
279617|NCT01301833|O4|Outcome|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
279618|NCT01301833|O3|Outcome|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
279619|NCT01301833|O2|Outcome|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
279620|NCT01301833|O1|Outcome|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
279621|NCT01301833|O4|Outcome|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
279622|NCT01301833|O3|Outcome|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
279623|NCT01301833|O2|Outcome|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
279624|NCT01301833|O1|Outcome|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
279625|NCT01301833|O4|Outcome|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
279626|NCT01301833|O3|Outcome|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
279627|NCT01301833|O2|Outcome|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
279628|NCT01301833|O1|Outcome|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
279629|NCT01301833|E4|Reported Event|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
279630|NCT01301833|E3|Reported Event|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
279631|NCT01301833|E2|Reported Event|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
279632|NCT01301833|E1|Reported Event|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
279633|NCT01301742|B1|Baseline|Entire Study Population|"The two treatments given in a randomised order were:~Empagliflozin 25mg (Empa) was given as a single dose on Day 1~Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empa was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.~Between treatments there was a washout period of at least 7 days."
279634|NCT01301742|P2|Participant Flow|Empa and Gemfibrozil First, Then Empa|Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions. This was followed by a washout period of at least 7 days, followed by Empa given as a single dose on Day 1.
279635|NCT01301742|P1|Participant Flow|Empa First, Then Empa and Gemfibrozil|Empagliflozin 25mg (Empa) was given as a single dose on Day 1, followed by a washout period of at least 7 days, followed by Gemfibrozil 600mg given twice daily for 5 days starting on day -2 and empa given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
279636|NCT01301742|O2|Outcome|Empa and Gemfibrozil|Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
279637|NCT01301742|O1|Outcome|Empa Alone|Empagliflozin (Empa) 25mg given as a single dose on Day 1.
279638|NCT01301742|O2|Outcome|Empa and Gemfibrozil|Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
279639|NCT01301742|O1|Outcome|Empa Alone|Empagliflozin (Empa) 25mg given as a single dose on Day 1.
279640|NCT01301742|O2|Outcome|Empa and Gemfibrozil|Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
279641|NCT01301742|O1|Outcome|Empa Alone|Empagliflozin (Empa) 25mg given as a single dose on Day 1.
279642|NCT01301742|E3|Reported Event|Gemfibrozil Alone|Between the first gemfibrozil administration and the empagliflozin administration, for the Empa and gemfibrozil treatment period.
279643|NCT01301742|E2|Reported Event|Empa and Gemfibrozil|Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
279644|NCT01301742|E1|Reported Event|Empa Alone|Empagliflozin (Empa) 25mg given as a single dose on Day 1.
279645|NCT01301729|B1|Baseline|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
279646|NCT01301729|P1|Participant Flow|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
279647|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
279941|NCT01301092|B4|Baseline|Total|Total of all reporting groups
279648|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
279649|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
279650|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
279651|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
279652|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
279653|NCT01301729|O1|Outcome|Tastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
279654|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
279655|NCT01301729|E1|Reported Event|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
279656|NCT01301508|B3|Baseline|Total|Total of all reporting groups
279657|NCT01301508|B2|Baseline|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
279658|NCT01301508|B1|Baseline|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
279659|NCT01301508|P2|Participant Flow|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
279660|NCT01301508|P1|Participant Flow|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate atopic dermatitis (AD) applied AN2898 ointment, 1 percent (%) to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
279661|NCT01301508|O2|Outcome|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
279662|NCT01301508|O1|Outcome|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
279663|NCT01301508|O2|Outcome|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
279664|NCT01301508|O1|Outcome|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
279665|NCT01301508|O2|Outcome|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
279693|NCT01301456|P9|Participant Flow|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279666|NCT01301508|O1|Outcome|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
279667|NCT01301508|O2|Outcome|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
279668|NCT01301508|O1|Outcome|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
279669|NCT01301508|O2|Outcome|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
279670|NCT01301508|O1|Outcome|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
279671|NCT01301508|O2|Outcome|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
279672|NCT01301508|O1|Outcome|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
279673|NCT01301508|O2|Outcome|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
279674|NCT01301508|O1|Outcome|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
279675|NCT01301508|E2|Reported Event|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
279676|NCT01301508|E1|Reported Event|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
279677|NCT01301456|B13|Baseline|Total|Total of all reporting groups
279678|NCT01301456|B12|Baseline|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279679|NCT01301456|B11|Baseline|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279680|NCT01301456|B10|Baseline|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279681|NCT01301456|B9|Baseline|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279682|NCT01301456|B8|Baseline|Stage 2: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279683|NCT01301456|B7|Baseline|Stage 1: PF-04856883 36 mg|Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
279684|NCT01301456|B6|Baseline|Stage 1: PF-04856883 24 mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
279685|NCT01301456|B5|Baseline|Stage 1: PF-04856883 18 mg|Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
279686|NCT01301456|B4|Baseline|Stage 1: PF-04856883 12 mg|Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
279687|NCT01301456|B3|Baseline|Stage 1: PF-04856883 8 mg|Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
279688|NCT01301456|B2|Baseline|Stage 1: PF-04856883 4 mg|Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
279689|NCT01301456|B1|Baseline|Stage 1: PF-04856883 Placebo|Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
279690|NCT01301456|P12|Participant Flow|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279691|NCT01301456|P11|Participant Flow|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279692|NCT01301456|P10|Participant Flow|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279735|NCT01301456|O1|Outcome|Stage 1: PF-04856883 Placebo|Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
279694|NCT01301456|P8|Participant Flow|Stage 2: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279695|NCT01301456|P7|Participant Flow|Stage 1: PF-04856883 36 mg|Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
279696|NCT01301456|P6|Participant Flow|Stage 1: PF-04856883 24 mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
279697|NCT01301456|P5|Participant Flow|Stage 1: PF-04856883 18 mg|Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
279698|NCT01301456|P4|Participant Flow|Stage 1: PF-04856883 12 mg|Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
279699|NCT01301456|P3|Participant Flow|Stage 1: PF-04856883 8 mg|Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
279700|NCT01301456|P2|Participant Flow|Stage 1: PF-04856883 4 mg|Participants received PF-04856883 4 milligram (mg) subcutaneous injection once on Day 1 in Stage 1.
279701|NCT01301456|P1|Participant Flow|Stage 1: PF-04856883 Placebo|Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
279702|NCT01301456|O4|Outcome|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279703|NCT01301456|O3|Outcome|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279704|NCT01301456|O2|Outcome|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279705|NCT01301456|O1|Outcome|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279706|NCT01301456|O6|Outcome|Stage 1: PF-04856883 36 mg|Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
279707|NCT01301456|O5|Outcome|Stage 1: PF-04856883 24 mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
279708|NCT01301456|O4|Outcome|Stage 1: PF-04856883 18 mg|Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
279709|NCT01301456|O3|Outcome|Stage 1: PF-04856883 12 mg|Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
279710|NCT01301456|O2|Outcome|Stage 1: PF-04856883 8 mg|Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
279711|NCT01301456|O1|Outcome|Stage 1: PF-04856883 4 mg|Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
279712|NCT01301456|O5|Outcome|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279713|NCT01301456|O4|Outcome|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279714|NCT01301456|O3|Outcome|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279715|NCT01301456|O2|Outcome|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279716|NCT01301456|O1|Outcome|Stage 2: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279717|NCT01301456|O7|Outcome|Stage 1: PF-04856883 36 mg|Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
279718|NCT01301456|O6|Outcome|Stage 1: PF-04856883 24 mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
279719|NCT01301456|O5|Outcome|Stage 1: PF-04856883 18 mg|Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
279720|NCT01301456|O4|Outcome|Stage 1: PF-04856883 12 mg|Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
279721|NCT01301456|O3|Outcome|Stage 1: PF-04856883 8 mg|Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
279722|NCT01301456|O2|Outcome|Stage 1: PF-04856883 4 mg|Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
279723|NCT01301456|O1|Outcome|Stage 1: PF-04856883 Placebo|Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
279724|NCT01301456|O5|Outcome|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279725|NCT01301456|O4|Outcome|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279726|NCT01301456|O3|Outcome|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279727|NCT01301456|O2|Outcome|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279728|NCT01301456|O1|Outcome|Stage 2: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279729|NCT01301456|O7|Outcome|Stage 1: PF-04856883 36 mg|Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
279730|NCT01301456|O6|Outcome|Stage 1: PF-04856883 24mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
279731|NCT01301456|O5|Outcome|Stage 1: PF-04856883 18 mg|Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
279732|NCT01301456|O4|Outcome|Stage 1: PF-04856883 12 mg|Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
279733|NCT01301456|O3|Outcome|Stage 1: PF-04856883 8 mg|Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
279734|NCT01301456|O2|Outcome|Stage 1: PF-04856883 4 mg|Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
279736|NCT01301456|O5|Outcome|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279737|NCT01301456|O4|Outcome|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279738|NCT01301456|O3|Outcome|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279739|NCT01301456|O2|Outcome|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279740|NCT01301456|O1|Outcome|Stage 2: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279741|NCT01301456|O5|Outcome|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279742|NCT01301456|O4|Outcome|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279743|NCT01301456|O3|Outcome|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279744|NCT01301456|O2|Outcome|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279745|NCT01301456|O1|Outcome|Stage 2: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279746|NCT01301456|O5|Outcome|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279747|NCT01301456|O4|Outcome|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279748|NCT01301456|O3|Outcome|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279749|NCT01301456|O2|Outcome|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279750|NCT01301456|O1|Outcome|Stage 2: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279751|NCT01301456|O7|Outcome|Stage 2: PF-04856883 36 mg|Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
279752|NCT01301456|O6|Outcome|Stage 1: PF-04856883 24 mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
279753|NCT01301456|O5|Outcome|Stage 1: PF-04856883 18 mg|Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
279754|NCT01301456|O4|Outcome|Stage 1: PF-04856883 12 mg|Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
279755|NCT01301456|O3|Outcome|Stage 1: PF-04856883 8 mg|Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
279756|NCT01301456|O2|Outcome|Stage 1: PF-04856883 4 mg|Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
279757|NCT01301456|O1|Outcome|Stage 1: PF-04856883 Placebo|Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
279758|NCT01301456|O5|Outcome|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279759|NCT01301456|O4|Outcome|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279760|NCT01301456|O3|Outcome|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279761|NCT01301456|O2|Outcome|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279762|NCT01301456|O1|Outcome|Stage 2: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279763|NCT01301456|O7|Outcome|Stage 1: PF-04856883 36 mg|Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
279764|NCT01301456|O6|Outcome|Stage 1: PF-04856883 24 mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
279765|NCT01301456|O5|Outcome|Stage 1: PF-04856883 18 mg|Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
279766|NCT01301456|O4|Outcome|Stage 1: PF-04856883 12 mg|Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
279767|NCT01301456|O3|Outcome|Stage 1: PF-04856883 8 mg|Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
279768|NCT01301456|O2|Outcome|Stage 1: PF-04856883 4 mg|Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
279769|NCT01301456|O1|Outcome|Stage 1: PF-04856883 Placebo|Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
279770|NCT01301456|O5|Outcome|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279771|NCT01301456|O4|Outcome|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279772|NCT01301456|O3|Outcome|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279773|NCT01301456|O2|Outcome|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279774|NCT01301456|O1|Outcome|Stage 2: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279775|NCT01301456|O7|Outcome|Stage 1: PF-04856883 36 mg|Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
279776|NCT01301456|O6|Outcome|Stage 1: PF-04856883 24 mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
279777|NCT01301456|O5|Outcome|Stage 1: PF-04856883 18 mg|Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
279778|NCT01301456|O4|Outcome|Stage 1: PF-04856883 12 mg|Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
279779|NCT01301456|O3|Outcome|Stage 1: PF-04856883 8 mg|Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
279780|NCT01301456|O2|Outcome|Stage 1: PF-04856883 4 mg|Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
279781|NCT01301456|O1|Outcome|Stage 1: PF-04856883 Placebo|Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
279782|NCT01301456|O5|Outcome|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279783|NCT01301456|O4|Outcome|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279784|NCT01301456|O3|Outcome|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279785|NCT01301456|O2|Outcome|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279786|NCT01301456|O1|Outcome|Stage 2: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279787|NCT01301456|O7|Outcome|Stage 1: PF-04856883 36 mg|Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
279788|NCT01301456|O6|Outcome|Stage 1: PF-04856883 24 mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
279789|NCT01301456|O5|Outcome|Stage 1: PF-04856883 18 mg|Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
279790|NCT01301456|O4|Outcome|Stage 1: PF-04856883 12 mg|Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
279791|NCT01301456|O3|Outcome|Stage 1: PF-04856883 8 mg|Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
279792|NCT01301456|O2|Outcome|Stage 1: PF-04856883 4 mg|Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
279793|NCT01301456|O1|Outcome|Stage 1: PF-04856883 Placebo|Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
279794|NCT01301456|O4|Outcome|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279795|NCT01301456|O3|Outcome|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279796|NCT01301456|O2|Outcome|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279797|NCT01301456|O1|Outcome|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279798|NCT01301456|O6|Outcome|Stage 1: PF-04856883 36 mg|Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
279799|NCT01301456|O5|Outcome|Stage 1: PF-04856883 24 mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
279800|NCT01301456|O4|Outcome|Stage 1: PF-04856883 18 mg|Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
279801|NCT01301456|O3|Outcome|Stage 1: PF-04856883 12 mg|Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
279802|NCT01301456|O2|Outcome|Stage 1: PF-04856883 8 mg|Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
279803|NCT01301456|O1|Outcome|Stage 1: PF-04856883 4 mg|Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
279804|NCT01301456|O4|Outcome|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279805|NCT01301456|O3|Outcome|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279806|NCT01301456|O2|Outcome|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279807|NCT01301456|O1|Outcome|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279808|NCT01301456|O6|Outcome|Stage 1: PF-04856883 36 mg|Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
279809|NCT01301456|O5|Outcome|Stage 1: PF-04856883 24 mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
279810|NCT01301456|O4|Outcome|Stage 1: PF-04856883 18 mg|Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
279811|NCT01301456|O3|Outcome|Stage 1: PF-04856883 12 mg|Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
279812|NCT01301456|O2|Outcome|Stage 1: PF-04856883 8 mg|Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
279813|NCT01301456|O1|Outcome|Stage 1: PF-04856883 4 mg|Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
279814|NCT01301456|O4|Outcome|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279815|NCT01301456|O3|Outcome|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279816|NCT01301456|O2|Outcome|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279817|NCT01301456|O1|Outcome|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279818|NCT01301456|O6|Outcome|Stage 1: PF-04856883 36 mg|Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
279819|NCT01301456|O5|Outcome|Stage 1: PF-04856883 24 mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
279820|NCT01301456|O4|Outcome|Stage 1: PF-04856883 18 mg|Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
279821|NCT01301456|O3|Outcome|Stage 1: PF-04856883 12 mg|Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
279822|NCT01301456|O2|Outcome|Stage 1: PF-04856883 8 mg|Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
279823|NCT01301456|O1|Outcome|Stage 1: PF-04856883 4 mg|Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
279824|NCT01301456|O4|Outcome|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279825|NCT01301456|O3|Outcome|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279826|NCT01301456|O2|Outcome|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279827|NCT01301456|O1|Outcome|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279828|NCT01301456|O6|Outcome|Stage 1: PF-04856883 36 mg|Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
279829|NCT01301456|O5|Outcome|Stage 1: PF-04856883 24 mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
279830|NCT01301456|O4|Outcome|Stage 1: PF-04856883 18 mg|Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
279831|NCT01301456|O3|Outcome|Stage 1: PF-04856883 12 mg|Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
279832|NCT01301456|O2|Outcome|Stage 1: PF-04856883 8 mg|Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
279833|NCT01301456|O1|Outcome|Stage 1: PF-04856883 4 mg|Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
279834|NCT01301456|O4|Outcome|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279835|NCT01301456|O3|Outcome|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279836|NCT01301456|O2|Outcome|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279837|NCT01301456|O1|Outcome|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279838|NCT01301456|O6|Outcome|Stage 1: PF-04856883 36 mg|Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
279839|NCT01301456|O5|Outcome|Stage 1: PF-04856883 24 mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
279840|NCT01301456|O4|Outcome|Stage 1: PF-04856883 18 mg|Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
279841|NCT01301456|O3|Outcome|Stage 1: PF-04856883 12 mg|Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
279842|NCT01301456|O2|Outcome|Stage 1: PF-04856883 8 mg|Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
279843|NCT01301456|O1|Outcome|Stage 1: PF-04856883 4 mg|Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
279844|NCT01301456|O4|Outcome|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279845|NCT01301456|O3|Outcome|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279846|NCT01301456|O2|Outcome|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279847|NCT01301456|O1|Outcome|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279848|NCT01301456|O6|Outcome|Stage 1: PF-04856883 36 mg|Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
279849|NCT01301456|O5|Outcome|Stage 1: PF-04856883 24 mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
279850|NCT01301456|O4|Outcome|Stage 1: PF-04856883 18 mg|Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
279851|NCT01301456|O3|Outcome|Stage 1: PF-04856883 12 mg|Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
279852|NCT01301456|O2|Outcome|Stage 1: PF-04856883 8 mg|Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
279853|NCT01301456|O1|Outcome|Stage 1: PF-04856883 4 mg|Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
279854|NCT01301456|O12|Outcome|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
314134|NCT01211145|E3|Reported Event|ZOMIG 2.5 mg|ZOMIG nasal spray
279855|NCT01301456|O11|Outcome|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279856|NCT01301456|O10|Outcome|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279857|NCT01301456|O9|Outcome|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279858|NCT01301456|O8|Outcome|Stage 2: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279859|NCT01301456|O7|Outcome|Stage 1: PF-04856883 36 mg|Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
279860|NCT01301456|O6|Outcome|Stage 1: PF-04856883 24 mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
279861|NCT01301456|O5|Outcome|Stage 1: PF-04856883 18 mg|Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
279862|NCT01301456|O4|Outcome|Stage 1: PF-04856883 12 mg|Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
279863|NCT01301456|O3|Outcome|Stage 1: PF-04856883 8 mg|Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
279864|NCT01301456|O2|Outcome|Stage 1: PF-04856883 4 mg|Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
279865|NCT01301456|O1|Outcome|Stage 1: PF-04856883 Placebo|Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
279866|NCT01301456|O12|Outcome|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279867|NCT01301456|O11|Outcome|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279868|NCT01301456|O10|Outcome|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279869|NCT01301456|O9|Outcome|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279870|NCT01301456|O8|Outcome|Stage 2: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279871|NCT01301456|O7|Outcome|Stage 1: PF-04856883 36 mg|Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
279872|NCT01301456|O6|Outcome|Stage 1: PF-04856883 24 mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
279873|NCT01301456|O5|Outcome|Stage 1: PF-04856883 18 mg|Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
279874|NCT01301456|O4|Outcome|Stage 1: PF-04856883 12 mg|Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
279875|NCT01301456|O3|Outcome|Stage 1: PF-04856883 8 mg|Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
279876|NCT01301456|O2|Outcome|Stage 1: PF-04856883 4 mg|Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
279877|NCT01301456|O1|Outcome|Stage 1: PF-04856883 Placebo|Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
279878|NCT01301456|O12|Outcome|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279879|NCT01301456|O11|Outcome|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279880|NCT01301456|O10|Outcome|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279881|NCT01301456|O9|Outcome|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279882|NCT01301456|O8|Outcome|Stage 2: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279883|NCT01301456|O7|Outcome|Stage 1: PF-04856883 36 mg|Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
279884|NCT01301456|O6|Outcome|Stage 1: PF-04856883 24 mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
279885|NCT01301456|O5|Outcome|Stage 1: PF-04856883 18 mg|Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
279886|NCT01301456|O4|Outcome|Stage 1: PF-04856883 12 mg|Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
279887|NCT01301456|O3|Outcome|Stage 1: PF-04856883 8 mg|Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
279888|NCT01301456|O2|Outcome|Stage 1: PF-04856883 4 mg|Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
279889|NCT01301456|O1|Outcome|Stage 1: PF-04856883 Placebo|Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
279890|NCT01301456|O12|Outcome|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279891|NCT01301456|O11|Outcome|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279892|NCT01301456|O10|Outcome|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279893|NCT01301456|O9|Outcome|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279894|NCT01301456|O8|Outcome|Stage 2: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279895|NCT01301456|O7|Outcome|Stage 1: PF-04856883 36mg Single Dose|Participants received subcutaneous injection of PF-04856883 4 mg by a 4-week follow up period in Stage 1
279896|NCT01301456|O6|Outcome|Stage 1: PF-04856883 24 mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
279897|NCT01301456|O5|Outcome|Stage 1: PF-04856883 18 mg|Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
279898|NCT01301456|O4|Outcome|Stage 1: PF-04856883 12 mg|Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
279899|NCT01301456|O3|Outcome|Stage 1: PF-04856883 8 mg|Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
279900|NCT01301456|O2|Outcome|Stage 1: PF-04856883 4 mg|Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
279901|NCT01301456|O1|Outcome|Stage 1: PF-04856883 Placebo|Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
279902|NCT01301456|O12|Outcome|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279903|NCT01301456|O11|Outcome|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279904|NCT01301456|O10|Outcome|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279905|NCT01301456|O9|Outcome|Stage 2: PF-04856883 12 mg|Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279906|NCT01301456|O8|Outcome|Stage 2: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279907|NCT01301456|O7|Outcome|Stage 1: PF-04856883 36 mg|Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
279908|NCT01301456|O6|Outcome|Stage 1: PF-04856883 24 mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
279909|NCT01301456|O5|Outcome|Stage 1: PF-04856883 18 mg|Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
279910|NCT01301456|O4|Outcome|Stage 1: PF-04856883 12 mg|Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
279911|NCT01301456|O3|Outcome|Stage 1: PF-04856883 8 mg|Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
279912|NCT01301456|O2|Outcome|Stage 1: PF-04856883 4 mg|Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
279913|NCT01301456|O1|Outcome|Stage 1: PF-04856883 Placebo|Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
279914|NCT01301456|E12|Reported Event|Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg|Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279915|NCT01301456|E11|Reported Event|Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg|Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279916|NCT01301456|E10|Reported Event|Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg|Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279917|NCT01301456|E9|Reported Event|Stage 2: PF-04856883 12.0 mg|Participants received single dose of PF-04856883 12.0 mg subcutaneous injection on Day 1, 8, 15 and 22 in Stage 2.
279918|NCT01301456|E8|Reported Event|Stage 2: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
279919|NCT01301456|E7|Reported Event|Stage 1: PF-04856883 36 mg|Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
279920|NCT01301456|E6|Reported Event|Stage 1: PF-04856883 24 mg|Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
279921|NCT01301456|E5|Reported Event|Stage 1: PF-04856883 18 mg|Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
279922|NCT01301456|E4|Reported Event|Stage 1: PF-04856883 12 mg|Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
279923|NCT01301456|E3|Reported Event|Stage 1: PF-04856883 8 mg|Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
279924|NCT01301456|E2|Reported Event|Stage 1: PF-04856883 4 mg|Participants received PF-04856883 4 milligram (mg) subcutaneous injection once on Day 1 in Stage 1.
279925|NCT01301456|E1|Reported Event|Stage 1: PF-04856883 Placebo|Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
279926|NCT01301274|B3|Baseline|Total|Total of all reporting groups
279927|NCT01301274|B2|Baseline|Isotonic|Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.
279928|NCT01301274|B1|Baseline|Hypotonic|Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.
279929|NCT01301274|P2|Participant Flow|Isotonic|Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.
279930|NCT01301274|P1|Participant Flow|Hypotonic|Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.
279931|NCT01301274|O2|Outcome|Isotonic Arm|patients who received for maintenance solution ClNa 0.9% in Dx 5%
279932|NCT01301274|O1|Outcome|Hypotonic Arm|patients who received for maintenance solution ClNa 0.9% in Dx 5%
279933|NCT01301274|O2|Outcome|Isotonic Arm|patients who received for maintenance solution ClNa 0.9% in Dx 5%
279934|NCT01301274|O1|Outcome|Hypotonic Arm|patients who received fro maintenance solution ClNa 0.45% in Dx 5%
279935|NCT01301274|O2|Outcome|Isotonic Arm|patients who received maintenance solution 0.9% ClNa in Dx 5%
279936|NCT01301274|O1|Outcome|Hypotonic Arm|patients who received maintenance solution 0.45% ClNa in Dx 5%
279937|NCT01301274|O2|Outcome|Isotonic Arm|Patients who received for maintenance solution 0.9% ClNa in Dx 5%
279938|NCT01301274|O1|Outcome|Hypotonic Arm|patients who received for maintenance solution 0.45% ClNa in Dx 5%
279939|NCT01301274|E2|Reported Event|Isotonic|Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.
279942|NCT01301092|B3|Baseline|Part C: LY2189265 Subcutaneous, Intramuscular|Participants were randomized to 2 sequences of 2 treatments. Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.75-mg intramuscular (IM) of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods
279943|NCT01301092|B2|Baseline|Part B: LY2189265 Subcutaneous, Intravenous|Participants were randomized to 2 sequences of 2 treatments. Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.1-mg intravenous (IV) dose of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods
279944|NCT01301092|B1|Baseline|Part A: LY2189265 Intravenous|Single 0.1 milligram (mg) intravenous (IV) dose of LY2189265
279945|NCT01301092|P3|Participant Flow|Part C: LY2189265 Subcutaneous, Intramuscular|Participants were randomized to 2 sequences of 2 treatments. Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.75-mg intramuscular (IM) of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods.
279946|NCT01301092|P2|Participant Flow|Part B: LY2189265 Subcutaneous, Intravenous|Participants were randomized to 2 sequences of 2 treatments. Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.1-mg intravenous (IV) dose of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods.
279947|NCT01301092|P1|Participant Flow|Part A: LY2189265 Intravenous|Single 0.1-milligram (mg) intravenous (IV) dose of LY2189265.
279948|NCT01301092|O2|Outcome|Part C: LY2189265 Subcutaneous|Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2
279949|NCT01301092|O1|Outcome|Part C: LY2189265 Intramuscular|Single 0.75-milligram (mg) intramuscular (IM) of LY2189265 in Period 1 or 2
279950|NCT01301092|O2|Outcome|Part C: LY2189265 Subcutaneous|Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2
279951|NCT01301092|O1|Outcome|Part C: LY2189265 Intramuscular|Single 0.75-milligram (mg) intramuscular (IM) of LY2189265 in Period 1or 2
279952|NCT01301092|O2|Outcome|Part B: LY2189265 Intravenous|Single 0.1-mg intravenous (IV) dose of LY2189265 in Period 1 or 2
279953|NCT01301092|O1|Outcome|Part B: LY2189265 Subcutaneous|Single 1.5-milligram (mg) subcutaneous (SC) dose of LY2189265 in Period 1 or 2
279954|NCT01301092|O2|Outcome|Part B: LY2189265 Intravenous|Single 0.1-mg intravenous (IV) dose of LY2189265 in Period 1 or 2
279955|NCT01301092|O1|Outcome|Part B: LY2189265 Subcutaneous|Single 1.5 mg-subcutaneous (SC) dose of LY2189265 in Period 1 or 2
279956|NCT01301092|E5|Reported Event|Part C: 0.75 mg SC LY2189265|Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2.
279957|NCT01301092|E4|Reported Event|Part C: 0.75 mg IM LY2189265|Single 0.75-mg intramuscular (IM) of LY2189265 in Period 1 or 2.
279958|NCT01301092|E3|Reported Event|Part B: 1.5 mg SC LY2189265|Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2.
279959|NCT01301092|E2|Reported Event|Part B: 0.1 mg IV LY2189265|Single 0.1-mg intravenous (IV) dose of LY2189265 in Period 1 or 2.
279960|NCT01301092|E1|Reported Event|Part A: 0.1 mg IV LY2189265|Single 0.1-milligram (mg) intravenous (IV) dose of LY2189265
279961|NCT01301079|B3|Baseline|Total|Total of all reporting groups
279962|NCT01301079|B2|Baseline|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. Patients in group 2 (G2) received remifentanil (0.4 μg/kg/min) and saline solution.~Saline : Patients in group N (placebo)will receive saline during surgery."
279963|NCT01301079|B1|Baseline|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group 1 (G1) received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min).~Ketamine : Patients in group ketamine will receive ketamine (5mcg/kg/min) during the surgery."
279964|NCT01301079|P2|Participant Flow|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
279965|NCT01301079|P1|Participant Flow|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
279966|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280063|NCT01301027|E1|Reported Event|Pioglitazone|"15 mg/day pioglitazone for 2 weeks, then 30 mg/day for remaining 24 weeks~Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks"
280064|NCT01301001|B1|Baseline|All Study Participants|44 subjects were randomized to Placebo First and 45 subjects were randomized to Gabapentin First
280074|NCT01301001|E1|Reported Event|Placebo|2 capsules am and 3 capsules pm
279967|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
279968|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
279969|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
279970|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
279971|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
279972|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
279973|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
279974|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
279975|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
279976|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
279977|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
280065|NCT01301001|P2|Participant Flow|Gabapentin First, Then Placebo|"Gabapentin capsule 3000 mg daily in first intervention period and Placebo capsule in second intervention (after washout period)~Placebo oral capsule: Placebo 2 capsules am and 3 capsules pm~Gabapentin: Gabapentin 1200 mg am and 1800 mg pm"
280255|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
279978|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
279979|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
279980|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
279981|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
279982|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
279983|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
279984|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
279985|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
279986|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
279987|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
279988|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280066|NCT01301001|P1|Participant Flow|Placebo First, Then Gabepentin|"Placebo capsule daily in first intervention period and Gabapentin capsule 3000 mg daily in in second intervention (after washout period)~Placebo oral capsule: Placebo 2 capsules am and 3 capsules pm~Gabapentin: Gabapentin 1200 mg am and 1800 mg pm"
280067|NCT01301001|O2|Outcome|Gabapentin|1200 mg am and 1800 mg pm
279989|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
279990|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
279991|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
279992|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
279993|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
279994|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
279995|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
279996|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
279997|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
279998|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
279999|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
280068|NCT01301001|O1|Outcome|Placebo|2 capsules am and 3 capsules pm
280069|NCT01301001|O2|Outcome|Gabapentin|1200 mg am and 1800 mg pm
280070|NCT01301001|O1|Outcome|Placebo|2 capsules am and 3 capsules pm
280071|NCT01301001|O2|Outcome|Gabapentin|2 capsules (1200 mg) am and 3 capsules (1800 mg) pm
280000|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280001|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280002|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280003|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280004|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280005|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280006|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280007|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280008|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280009|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280010|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280072|NCT01301001|O1|Outcome|Placebo|2 capsules am and 3 capsules pm
280011|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280012|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280013|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280014|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280015|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280016|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280017|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280018|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280019|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280020|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280021|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group 1 (G1) received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280256|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
280022|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280023|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280024|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280025|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
280026|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280027|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280028|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280029|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280030|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution.~Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block.~Saline: Patients in group N (placebo) was administrated saline during surgery."
280031|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min).~Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block.~Ketamine: Patients in group ketamine was administrated ketamine (5mcg/kg/min) during the surgery."
280032|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280033|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280034|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280035|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280036|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280037|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280038|NCT01301079|E2|Reported Event|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280039|NCT01301079|E1|Reported Event|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and (ketamine 5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
280040|NCT01301066|B3|Baseline|Total|Total of all reporting groups
280041|NCT01301066|B2|Baseline|Pravastatin 40 mg QD|Pravastatin: Pravastatin 40 mg QD
280042|NCT01301066|B1|Baseline|Pitavastatin 4 mg QD|Pitavastatin: Pitavastatin 4 mg QD
280043|NCT01301066|P2|Participant Flow|Pravastatin 40 mg QD|Pravastatin: Pravastatin 40 mg QD
280044|NCT01301066|P1|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin: Pitavastatin 4 mg QD
280045|NCT01301066|O2|Outcome|Pravastatin 40 mg QD|Pravastatin: Pravastatin 40 mg QD
280046|NCT01301066|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin: Pitavastatin 4 mg QD
280047|NCT01301066|E2|Reported Event|Pravastatin 40 mg QD|Pravastatin: Pravastatin 40 mg QD
280048|NCT01301066|E1|Reported Event|Pitavastatin 4 mg QD|Pitavastatin: Pitavastatin 4 mg QD
280049|NCT01301027|B3|Baseline|Total|Total of all reporting groups
280050|NCT01301027|B2|Baseline|Placebo|Placebo: 1 pill a day for 26 weeks
280051|NCT01301027|B1|Baseline|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
280052|NCT01301027|P2|Participant Flow|Placebo|Placebo: 1 pill a day for 26 weeks
280053|NCT01301027|P1|Participant Flow|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
280054|NCT01301027|O2|Outcome|Placebo|Placebo: 1 pill a day for 26 weeks
280055|NCT01301027|O1|Outcome|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
280056|NCT01301027|O2|Outcome|Placebo|Placebo: 1 pill a day for 26 weeks
280057|NCT01301027|O1|Outcome|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
280058|NCT01301027|O2|Outcome|Placebo|Placebo: 1 pill a day for 26 weeks
280059|NCT01301027|O1|Outcome|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
280060|NCT01301027|O2|Outcome|Placebo|Placebo: 1 pill a day for 26 weeks
280061|NCT01301027|O1|Outcome|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
280062|NCT01301027|E2|Reported Event|Placebo|"1 placebo pill a day matching the pioglitazone treatment for 26 weeks~Placebo: 1 pill a day for 26 weeks"
280075|NCT01300923|B1|Baseline|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day)
280076|NCT01300923|P2|Participant Flow|Autism Spectrum Disorder (ADS)|This baseline comparison group will participated in only and biomarker portion of subject characterization.
280077|NCT01300923|P1|Participant Flow|Acamprosate|"The maximum dose of acamprosate to be used in this study is 1998 mg per day for those subjects weighing greater than 60kg and 1332 mg per day for those less weighing less than 60kg.~Acamprosate"
280078|NCT01300923|O1|Outcome|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day)
280079|NCT01300923|O1|Outcome|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day)
280080|NCT01300923|O1|Outcome|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day).
280081|NCT01300923|O1|Outcome|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day)
280082|NCT01300923|O1|Outcome|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day)
280083|NCT01300923|O1|Outcome|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day)
280084|NCT01300923|O1|Outcome|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day)
280085|NCT01300923|O1|Outcome|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day).
280086|NCT01300923|E1|Reported Event|Acamprosate|The maximum dose of acamprosate to be used in this study is 1998 mg per day for those subjects weighing greater than 60kg and 1332 mg per day for those less weighing less than 60kg.
280087|NCT01300819|B3|Baseline|Total|Total of all reporting groups
280088|NCT01300819|B2|Baseline|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280089|NCT01300819|B1|Baseline|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280090|NCT01300819|P2|Participant Flow|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280091|NCT01300819|P1|Participant Flow|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280092|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280093|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280094|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280095|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280096|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280097|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280098|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280099|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280100|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280101|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280102|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280103|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280104|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280105|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280106|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280107|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280108|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280109|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280257|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
280110|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280111|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280112|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280113|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280114|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280115|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280116|NCT01300819|E2|Reported Event|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280117|NCT01300819|E1|Reported Event|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
280118|NCT01300767|B1|Baseline|Lotrafilcon B /Balafilcon A|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with balafilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
280119|NCT01300767|P1|Participant Flow|Lotrafilcon B /Balafilcon A|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with balafilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
280120|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
280121|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
280122|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
280123|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
280124|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
280125|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
280126|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
280127|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
280128|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
280129|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
280130|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
280131|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
280132|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
280133|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
280134|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
280135|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
280136|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
280137|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
280138|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
280139|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
280140|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
280141|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
280142|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
280143|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
280144|NCT01300767|E2|Reported Event|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
280145|NCT01300767|E1|Reported Event|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
280146|NCT01300741|B1|Baseline|Lotrafilcon B / Galyfilcon A|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with galyfilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
280147|NCT01300741|P1|Participant Flow|Lotrafilcon B / Galyfilcon A|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with galyfilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
280148|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
280149|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
280150|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
280151|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
280152|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
280153|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
280154|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
280155|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
280156|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
280157|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
280158|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
280159|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
280160|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
280161|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
280162|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
280163|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
280164|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
280258|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
280165|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
280166|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
280167|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
280168|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
280169|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
280170|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
280171|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
280172|NCT01300741|E2|Reported Event|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
280173|NCT01300741|E1|Reported Event|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
280174|NCT01300728|B3|Baseline|Total|Total of all reporting groups
280175|NCT01300728|B2|Baseline|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
280176|NCT01300728|B1|Baseline|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
280177|NCT01300728|P2|Participant Flow|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
280178|NCT01300728|P1|Participant Flow|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
280179|NCT01300728|O2|Outcome|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
280180|NCT01300728|O1|Outcome|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
280181|NCT01300728|O2|Outcome|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
280182|NCT01300728|O1|Outcome|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
280183|NCT01300728|O2|Outcome|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
280184|NCT01300728|O1|Outcome|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
280185|NCT01300728|O2|Outcome|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
280186|NCT01300728|O1|Outcome|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
280187|NCT01300728|O2|Outcome|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
280188|NCT01300728|O1|Outcome|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
280189|NCT01300728|E2|Reported Event|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
280190|NCT01300728|E1|Reported Event|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
280191|NCT01300650|B1|Baseline|Anakinra|
280192|NCT01300650|P1|Participant Flow|Anakinra|Anakinra 100 mg subcutaneous daily injection
280193|NCT01300650|O1|Outcome|Anakinra|Anakinra 100 mg subcutaneous injection
280194|NCT01300650|O1|Outcome|Anakinra|Anakinra 100 mg subcutaneous daily injection
280195|NCT01300650|O1|Outcome|Anakinra|Anakinra 100 mg subcutaneous daily injection
280196|NCT01300650|E1|Reported Event|Anakinra|
280197|NCT01300624|B1|Baseline|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
280198|NCT01300624|P1|Participant Flow|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
280199|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Verb Network Strengthening Treatment (VNeST) tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced.~Verb Network Strengthening Treatment: Treatment to improve word retrieval in sentences and discourse for persons with aphasia due to stroke."
280200|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
280201|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
280202|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
280203|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
280204|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
280205|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
280231|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
314135|NCT01211145|E2|Reported Event|ZOMIG 0.5 mg|ZOMIG nasal spray
280206|NCT01300624|E1|Reported Event|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
280207|NCT01300559|B3|Baseline|Total|Total of all reporting groups
280208|NCT01300559|B2|Baseline|No Treatment|Unipolar electrocautery without Tissuelink device will be used in this arm of the study.
280209|NCT01300559|B1|Baseline|Treatment Group|Tissuelink device plus Unipolar electrocautery will be used in this arm of the study.
280210|NCT01300559|P2|Participant Flow|No Treatment|Unipolar electrocautery without Tissuelink device will be used in this arm of the study.
280211|NCT01300559|P1|Participant Flow|Treatment Group|Tissuelink device plus Unipolar electrocautery will be used in this arm of the study.
280212|NCT01300559|O2|Outcome|No Treatment Group|Unipolar electrocautery without Tissuelink device will be used in this arm of the study. Hemoglobin loss for the participants in this group will be measured in g/dl.
280213|NCT01300559|O1|Outcome|Treatment Group|Tissuelink device plus Unipolar electrocautery will be used in this arm of the study. Hemoglobin loss for the participants in this group will be measured in g/dl.
280214|NCT01300559|E2|Reported Event|No Treatment|Unipolar electrocautery without Tissuelink device will be used in this arm of the study.
280215|NCT01300559|E1|Reported Event|Treatment Group|Tissuelink device plus Unipolar electrocautery will be used in this arm of the study.
280216|NCT01300546|B3|Baseline|Total|Total of all reporting groups
280217|NCT01300546|B2|Baseline|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
280218|NCT01300546|B1|Baseline|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
280219|NCT01300546|P2|Participant Flow|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
280220|NCT01300546|P1|Participant Flow|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
280221|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
280222|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
280223|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
280224|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
280225|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
280226|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
280227|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
280228|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
280229|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
280230|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
280232|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
280233|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
280234|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
280235|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
280236|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
280237|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
280238|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
280239|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
280240|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
280241|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
280242|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
280243|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
280244|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
280245|NCT01300546|E2|Reported Event|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
280246|NCT01300546|E1|Reported Event|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
280247|NCT01300455|B3|Baseline|Total|Total of all reporting groups
280248|NCT01300455|B2|Baseline|Placebo Then Suvorexant (40 mg)|Period 1 consists of placebo administered once daily for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. In Period 2, Suvorexant (40 mg tablets) administered orally, once daily, for 4 consecutive days in the evening.
280249|NCT01300455|B1|Baseline|Suvorexant (40 mg) Then Placebo|In Period 1, Suvorexant (40 mg tablets) administered orally, once daily, for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. Period 2 consists of placebo administered once daily for 4 consecutive days in the evening.
280250|NCT01300455|P2|Participant Flow|Placebo Then Suvorexant (40 mg)|Period 1 consists of placebo administered once daily for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. In Period 2, suvorexant (40 mg tablets) administered orally, once daily, for 4 consecutive days in the evening.
280251|NCT01300455|P1|Participant Flow|Suvorexant (40 mg) Then Placebo|In Period 1, suvorexant (40 mg tablets) administered orally, once daily, for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. Period 2 consists of placebo administered once daily for 4 consecutive days in the evening.
280252|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
280253|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
280254|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
314136|NCT01211145|E1|Reported Event|Placebo|Placebo to ZOMIG nasal spray
280259|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
280260|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
280261|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
280262|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
280263|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
280264|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
280265|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
280266|NCT01300455|E2|Reported Event|Placebo|Participants administered placebo.
280267|NCT01300455|E1|Reported Event|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
280268|NCT01300351|B3|Baseline|Total|Total of all reporting groups
280269|NCT01300351|B2|Baseline|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
280270|NCT01300351|B1|Baseline|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
280271|NCT01300351|P2|Participant Flow|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
280272|NCT01300351|P1|Participant Flow|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
280273|NCT01300351|O2|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
280274|NCT01300351|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
280275|NCT01300351|O2|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
280276|NCT01300351|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
280277|NCT01300351|O2|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
280278|NCT01300351|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
280279|NCT01300351|O2|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
280280|NCT01300351|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
280281|NCT01300351|O2|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
280282|NCT01300351|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
280283|NCT01300351|E2|Reported Event|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
280284|NCT01300351|E1|Reported Event|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
280285|NCT01300338|B3|Baseline|Total|Total of all reporting groups
280286|NCT01300338|B2|Baseline|Blood Pressure Without Telemetry|"Blood pressure self monitor without telemetry~Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry"
280287|NCT01300338|B1|Baseline|Blood Pressure With Telemetry|"Blood pressure monitor with telemetry~blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager"
280288|NCT01300338|P2|Participant Flow|Blood Pressure Without Telemetry|"Blood pressure self monitor without telemetry~Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry."
280289|NCT01300338|P1|Participant Flow|Blood Pressure With Telemetry|"Blood pressure monitor with telemetry~blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager"
280290|NCT01300338|O2|Outcome|Blood Pressure Without Telemetry|"Blood pressure self monitor without telemetry~Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry"
280291|NCT01300338|O1|Outcome|Blood Pressure With Telemetry|"Blood pressure monitor with telemetry~blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager"
280292|NCT01300338|O2|Outcome|Blood Pressure Without Telemetry|"Blood pressure self monitor without telemetry~Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry"
280293|NCT01300338|O1|Outcome|Blood Pressure With Telemetry|"Blood pressure monitor with telemetry~blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager"
280294|NCT01300338|E2|Reported Event|Blood Pressure Without Telemetry|"Blood pressure self monitor without telemetry~Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry"
280295|NCT01300338|E1|Reported Event|Blood Pressure With Telemetry|"Blood pressure monitor with telemetry~blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager"
280296|NCT01300286|B1|Baseline|RiaSTAP|RiaSTAP: One time dose of 70 mg/kg will be administered intravenously
280297|NCT01300286|P1|Participant Flow|RiaSTAP|RiaSTAP: One time dose of 70 mg/kg will be administered intravenously.
280298|NCT01300286|O1|Outcome|RiaSTAP|"One time dose of 70 mg/kg will be administered intravenously.~RiaSTAP: One time dose of 70 mg/kg will be administered intravenously."
280299|NCT01300286|O1|Outcome|RiaSTAP|"One time dose of 70 mg/kg will be administered intravenously.~RiaSTAP: One time dose of 70 mg/kg will be administered intravenously."
280300|NCT01300286|O1|Outcome|RiaSTAP|"One time dose of 70 mg/kg will be administered intravenously.~RiaSTAP: One time dose of 70 mg/kg will be administered intravenously."
280301|NCT01300286|O1|Outcome|RiaSTAP|One time dose of 70 mg/kg will be administered intravenously.
280302|NCT01300286|O1|Outcome|RiaSTAP|One time dose of 70 mg/kg will be administered intravenously.
280303|NCT01300286|E1|Reported Event|RiaSTAP|RiaSTAP: One time dose of 70 mg/kg will be administered intravenously.
280304|NCT01300260|B3|Baseline|Total|Total of all reporting groups
280305|NCT01300260|B2|Baseline|Participants With Type 2 Diabetes Mellitus (T2DM)|Includes participants with T2DM randomized to receive 1.5 mg LY2189265 (Dulaglutide) first or Placebo first on Day 1 of either treatment sequence.
280306|NCT01300260|B1|Baseline|Healthy Participants|Includes healthy participants randomized to receive 1.5 milligram (mg) LY2189265 (Dulaglutide) first or Placebo first on Day 1 of either treatment sequence.
280307|NCT01300260|P2|Participant Flow|Placebo First, Then LY2189265|"Includes healthy participants and participants with T2DM. Placebo: Single subcutaneous (SC) injection of Placebo on Day 1 of Period 1. LY2189265 (Dulaglutide): Single 1.5 milligram (mg) SC injection on Day 1 of Period 2.~On Day 3 of each period, participants received a 6-hour (hr) insulin infusion, followed by an intravenous (IV) dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes [min]). Three hr later, a 2nd IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hr glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hr glucose >10 mmol/L) was administered, followed by a 20% dextrose at the set infusion rate of 600 milliliter/hr [mL/hr] for 35 min. Fifteen min after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.~There was a washout period of ≥28 days between Periods 1 & 2."
280308|NCT01300260|P1|Participant Flow|LY2189265 First, Then Placebo|"Includes healthy participants or participants with T2DM. LY2189265 (Dulaglutide): Single 1.5 milligram (mg) subcutaneous (SC) injection on Day 1 of Period 1. Placebo: Single SC injection of Placebo on Day 1 of Period 2.~On Day 3 of each period, participants received a 6-hour (hr) insulin infusion, followed by an intravenous (IV) dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes [min]). Three hr later, a 2nd IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hr glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hr glucose >10 mmol/L) was administered, followed by a 20% dextrose at the set infusion rate of 600 milliliter/hr [mL/hr] for 35 min. Fifteen min after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.~There was a washout period of ≥28 days between Periods 1 & 2."
280309|NCT01300260|O4|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
280310|NCT01300260|O3|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
280311|NCT01300260|O2|Outcome|Healthy Participants: LY2189265|Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
280312|NCT01300260|O1|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered
280313|NCT01300260|O4|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
280314|NCT01300260|O3|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
280466|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
280315|NCT01300260|O2|Outcome|Healthy Participants: LY2189265|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
280316|NCT01300260|O1|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
280317|NCT01300260|O4|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
280318|NCT01300260|O3|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
280319|NCT01300260|O2|Outcome|Healthy Participants: LY2189265|Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
280320|NCT01300260|O1|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
280321|NCT01300260|O4|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
280322|NCT01300260|O3|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
280323|NCT01300260|O2|Outcome|Healthy Participants: LY2189265|Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
280324|NCT01300260|O1|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
280325|NCT01300260|O4|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
280326|NCT01300260|O3|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes)
280327|NCT01300260|O2|Outcome|Healthy Participants: LY2189265|Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
280328|NCT01300260|O1|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
280329|NCT01300260|O4|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
280330|NCT01300260|O3|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
280331|NCT01300260|O2|Outcome|Healthy Participants: LY2189265|Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
280332|NCT01300260|O1|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
280333|NCT01300260|E4|Reported Event|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants who received at least 1 subcutaneous injection of 1.5 milligram (mg) LY2189265
280467|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
280334|NCT01300260|E3|Reported Event|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants who received at least 1 subcutaneous injection of Placebo
280335|NCT01300260|E2|Reported Event|Healthy Participants: LY2189265|Healthy participants who received at least 1 subcutaneous injection of 1.5 milligram (mg) LY2189265
280336|NCT01300260|E1|Reported Event|Healthy Participants: Placebo|Healthy participants who received at least 1 subcutaneous injection of Placebo
280337|NCT01300247|B3|Baseline|Total|Total of all reporting groups
280338|NCT01300247|B2|Baseline|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
280339|NCT01300247|B1|Baseline|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
280340|NCT01300247|P2|Participant Flow|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
280341|NCT01300247|P1|Participant Flow|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 milligrams [mg] intravenous [IV] infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 milligrams per meter square [mg/m^2] IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
280342|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
280343|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
280344|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
280345|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
280346|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
280347|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
280348|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
280349|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
280350|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
280351|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
280352|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
280353|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
280354|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
281726|NCT01296672|E2|Reported Event|Placebo|Placebo every day by mouth for 3 months
280355|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
280356|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
280357|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
280358|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
280359|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
280360|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
280361|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
280362|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
280363|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
280364|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
280365|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
280366|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
280367|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
280368|NCT01300247|E2|Reported Event|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
280369|NCT01300247|E1|Reported Event|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
280370|NCT01300234|B3|Baseline|Total|Total of all reporting groups
280371|NCT01300234|B2|Baseline|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
280372|NCT01300234|B1|Baseline|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
280373|NCT01300234|P2|Participant Flow|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
280374|NCT01300234|P1|Participant Flow|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
280375|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
280376|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
280377|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
280378|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
280379|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
280380|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
280381|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
280382|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
280383|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
280384|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
280385|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
280386|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
280387|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
280388|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
280389|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
280390|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
280391|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
280392|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
280393|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
280394|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
280395|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
280396|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
280397|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
280398|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
280399|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
280400|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
280401|NCT01300234|E2|Reported Event|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
280402|NCT01300234|E1|Reported Event|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
280403|NCT01300052|B3|Baseline|Total|Total of all reporting groups
280404|NCT01300052|B2|Baseline|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
280405|NCT01300052|B1|Baseline|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
280406|NCT01300052|P2|Participant Flow|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
280407|NCT01300052|P1|Participant Flow|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator
280408|NCT01300052|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
280409|NCT01300052|O1|Outcome|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
280410|NCT01300052|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
280468|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
314137|NCT01211106|B3|Baseline|Total|Total of all reporting groups
280411|NCT01300052|O1|Outcome|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
280412|NCT01300052|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
280413|NCT01300052|O1|Outcome|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
280414|NCT01300052|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
280415|NCT01300052|O1|Outcome|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
280416|NCT01300052|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
280417|NCT01300052|O1|Outcome|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
280418|NCT01300052|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
280419|NCT01300052|O1|Outcome|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
280420|NCT01300052|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
280421|NCT01300052|O1|Outcome|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
280422|NCT01300052|E2|Reported Event|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
280423|NCT01300052|E1|Reported Event|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
280424|NCT01299961|B1|Baseline|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
280425|NCT01299961|P1|Participant Flow|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
280426|NCT01299961|O1|Outcome|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
280427|NCT01299961|O1|Outcome|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
280428|NCT01299961|O1|Outcome|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
280429|NCT01299961|E1|Reported Event|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
280430|NCT01299909|B4|Baseline|Total|Total of all reporting groups
280431|NCT01299909|B3|Baseline|Quitline|Telephone-based smoking cessation treatment via the Wisconsin Tobacco Quit Line (WTQL) consisting of 2 weeks of nicotine patches, self-help materials, an interactive website, and unlimited follow-up calls to the WTQL at no cost.
280432|NCT01299909|B2|Baseline|Integrated Training for Smokers|"ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.~Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program"
280433|NCT01299909|B1|Baseline|Mindfulness Training for Smokers|"MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.~Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website."
280434|NCT01299909|P3|Participant Flow|Quitline|Non-Randomized, Treatment as Usual condition; participants self-selected to this group and received smoking cessation treatment via the Wisconsin Tobacco Quit Line (WTQL).
280435|NCT01299909|P2|Participant Flow|Integrated Training for Smokers|"ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.~Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program"
280436|NCT01299909|P1|Participant Flow|Mindfulness Training for Smokers|"MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.~Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website."
280437|NCT01299909|O2|Outcome|Integrated Training for Smokers|"ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.~Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program"
280438|NCT01299909|O1|Outcome|Mindfulness Training for Smokers|"MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.~Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website."
280469|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
280470|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
315777|NCT01205451|B3|Baseline|Total|Total of all reporting groups
280439|NCT01299909|O2|Outcome|Integrated Training for Smokers|"ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.~Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program"
280440|NCT01299909|O1|Outcome|Mindfulness Training for Smokers|"MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.~Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website."
280441|NCT01299909|O2|Outcome|Integrated Training for Smokers|"ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.~Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program"
280442|NCT01299909|O1|Outcome|Mindfulness Training for Smokers|"MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.~Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website."
280443|NCT01299909|O2|Outcome|Integrated Training for Smokers|"ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.~Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program"
280444|NCT01299909|O1|Outcome|Mindfulness Training for Smokers|"MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.~Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website."
280445|NCT01299909|E3|Reported Event|Quitline|Telephone-based smoking cessation treatment via the Wisconsin Tobacco Quit Line (WTQL) consisting of 2 weeks of nicotine patches, self-help materials, an interactive website, and unlimited follow-up calls to the WTQL at no cost.
280446|NCT01299909|E2|Reported Event|Integrated Training for Smokers|"ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.~Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program"
280447|NCT01299909|E1|Reported Event|Mindfulness Training for Smokers|"MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.~Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website."
280448|NCT01299896|B3|Baseline|Total|Total of all reporting groups
280449|NCT01299896|B2|Baseline|Coordinated Care|"A CTQ Coordinator will coordinate the delivery of smoking related care.~Coordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly."
280450|NCT01299896|B1|Baseline|Usual Care|"Participants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.~Usual Care: Standard therapy to help participants with smoking cessation."
280451|NCT01299896|P2|Participant Flow|Coordinated Care|"A CTQ Coordinator will coordinate the delivery of smoking related care.~Coordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly."
280452|NCT01299896|P1|Participant Flow|Usual Care|"Participants will continue to receive all the care currently offered in the Veterans Administration Pittsburgh Healthcare System (VAPHS), including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.~Usual Care: Standard therapy to help participants with smoking cessation."
280453|NCT01299896|O2|Outcome|Coordinated Care|"A CTQ Coordinator will coordinate the delivery of smoking related care.~Coordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly."
280454|NCT01299896|O1|Outcome|Usual Care|"Participants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.~Usual Care: Standard therapy to help participants with smoking cessation."
280455|NCT01299896|E2|Reported Event|Coordinated Care|"A CTQ Coordinator will coordinate the delivery of smoking related care.~Coordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly."
280456|NCT01299896|E1|Reported Event|Usual Care|"Participants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.~Usual Care: Standard therapy to help participants with smoking cessation."
280457|NCT01299805|B3|Baseline|Total|Total of all reporting groups
280458|NCT01299805|B2|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
280459|NCT01299805|B1|Baseline|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
280460|NCT01299805|P2|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
280461|NCT01299805|P1|Participant Flow|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
280462|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
280463|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
280464|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
280465|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
280471|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
280472|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
280473|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
280474|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
280475|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
280476|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
280477|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
280478|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
280479|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
280480|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
280481|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
280482|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
280483|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
280484|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
280485|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
280486|NCT01299805|E2|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
280487|NCT01299805|E1|Reported Event|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
280488|NCT01299610|B4|Baseline|Total|Total of all reporting groups
280489|NCT01299610|B3|Baseline|Treatment 3: GW870086 0.2%, FP 0.05% and Placebo|Participants applied GW870086, 0.2% cream, FP, 0.05% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280490|NCT01299610|B2|Baseline|Treatment 2: GW870086 2.0%, FP 0.05% and Placebo|Participants applied GW870086, 2.0% cream, Fluticasone Propionate (FP) 0.05% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280491|NCT01299610|B1|Baseline|Treatment 1: GW870086, 2.0%, GW870086, 0.2% and Placebo|Participants applied GW870086, 2.0% cream, GW870086, 0.2% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and the study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of the pots, the use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. The participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280492|NCT01299610|P3|Participant Flow|Treatment 3: GW870086 0.2%, FP 0.05% and Placebo|Participants applied GW870086 0.2% cream, FP 0.05% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280493|NCT01299610|P2|Participant Flow|Treatment 2: GW870086 2.0%, FP 0.05% and Placebo|Participants applied GW870086 2.0% cream, Fluticasone Propionate (FP) 0.05% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280494|NCT01299610|P1|Participant Flow|Treatment 1: GW870086, 2.0%, GW870086, 0.2% and Placebo|Participants applied GW870086 2.0% cream, GW870086 0.2% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and the study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of the pots, the use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. The participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280495|NCT01299610|O4|Outcome|FP, 0.05% Cream|Eligible participants applied FP, 0.05% cream to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280496|NCT01299610|O3|Outcome|Placebo|Eligible participants applied matching placebo to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280497|NCT01299610|O2|Outcome|GW870086, 2.0% Cream|Eligible participants applied GW870086, 2.0% cream to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280498|NCT01299610|O1|Outcome|GW870086, 0.2% Cream|Participants applied GW870086, 0.2% cream to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280499|NCT01299610|O4|Outcome|FP, 0.05% Cream|Eligible participants applied FP, 0.05% cream to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280500|NCT01299610|O3|Outcome|Placebo|Eligible participants applied matching placebo to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280501|NCT01299610|O2|Outcome|GW870086, 2.0% Cream|Eligible participants applied GW870086, 2.0% cream to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280543|NCT01299584|O1|Outcome|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
320539|NCT01193686|O2|Outcome|Recipients of PV|
280502|NCT01299610|O1|Outcome|GW870086, 0.2% Cream|Participants applied GW870086, 0.2% cream to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280503|NCT01299610|O4|Outcome|FP, 0.05% Cream|Eligible participants applied FP, 0.05% cream to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280504|NCT01299610|O3|Outcome|Placebo|Eligible participants applied matching placebo to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280505|NCT01299610|O2|Outcome|GW870086, 2.0% Cream|Eligible participants applied GW870086, 2.0% cream to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280506|NCT01299610|O1|Outcome|GW870086, 0.2% Cream|Participants applied GW870086, 0.2% cream to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280507|NCT01299610|O4|Outcome|FP, 0.05% Cream|Eligible participants applied FP, 0.05% cream to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280508|NCT01299610|O3|Outcome|Placebo|Eligible participants applied matching placebo to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280509|NCT01299610|O2|Outcome|GW870086, 2.0% Cream|Eligible participants applied GW870086, 2.0% cream to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280544|NCT01299584|E1|Reported Event|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
280545|NCT01299571|B1|Baseline|Avodart 0.5 mg|Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily
320540|NCT01193686|O1|Outcome|Veteran Peer Visitors|
280510|NCT01299610|O1|Outcome|GW870086, 0.2% Cream|Participants applied GW870086, 0.2% cream to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280511|NCT01299610|O3|Outcome|Treatment 3: GW870086 0.2%, FP 0.05% and Placebo|Participants applied GW870086, 0.2% cream, FP, 0.05% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280512|NCT01299610|O2|Outcome|Treatment 2: GW870086 2.0%, FP 0.05% and Placebo|Participants applied GW870086, 2.0% cream, Fluticasone Propionate (FP) 0.05% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280513|NCT01299610|O1|Outcome|Treatment 1: GW870086, 2.0%, GW870086, 0.2% and Placebo|Participants applied GW870086, 2.0% cream, GW870086, 0.2% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and the study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of the pots, the use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. The participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280514|NCT01299610|O3|Outcome|Treatment 3: GW870086 0.2%, FP 0.05% and Placebo|Participants applied GW870086, 0.2% cream, FP, 0.05% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280515|NCT01299610|O2|Outcome|Treatment 2: GW870086 2.0%, FP 0.05% and Placebo|Participants applied GW870086, 2.0% cream, Fluticasone Propionate (FP) 0.05% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280516|NCT01299610|O1|Outcome|Treatment 1: GW870086, 2.0%, GW870086, 0.2% and Placebo|Participants applied GW870086, 2.0% cream, GW870086, 0.2% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and the study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of the pots, the use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. The participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280546|NCT01299571|P1|Participant Flow|Avodart 0.5 mg|Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily.
280547|NCT01299571|O1|Outcome|Avodart 0.5 mg|Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily
280548|NCT01299571|O1|Outcome|Avodart 0.5 mg|Avodart capsule containing 0.5 mg of dutasteride was administered orally once daily
320541|NCT01193686|O2|Outcome|Recipients of PV|
280517|NCT01299610|O3|Outcome|Treatment 3: GW870086 0.2%, FP 0.05% and Placebo|Participants applied GW870086, 0.2% cream, FP, 0.05% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280518|NCT01299610|O2|Outcome|Treatment 2: GW870086 2.0%, FP 0.05% and Placebo|Participants applied GW870086, 2.0% cream, Fluticasone Propionate (FP) 0.05% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280519|NCT01299610|O1|Outcome|Treatment 1: GW870086, 2.0%, GW870086, 0.2% and Placebo|Participants applied GW870086, 2.0% cream, GW870086, 0.2% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and the study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of the pots, the use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. The participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280520|NCT01299610|O3|Outcome|Treatment 3: GW870086 0.2%, FP 0.05% and Placebo|Participants applied GW870086, 0.2% cream, FP, 0.05% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280521|NCT01299610|O2|Outcome|Treatment 2: GW870086 2.0%, FP 0.05% and Placebo|Participants applied GW870086, 2.0% cream, Fluticasone Propionate (FP) 0.05% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280522|NCT01299610|O1|Outcome|Treatment 1: GW870086, 2.0%, GW870086, 0.2% and Placebo|Participants applied GW870086, 2.0% cream, GW870086, 0.2% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and the study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of the pots, the use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. The participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280523|NCT01299610|O4|Outcome|FP, 0.05% Cream|Eligible participants applied FP, 0.05% cream to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280549|NCT01299571|O1|Outcome|Avodart 0.5 mg|Avodart capsule containing 0.5 mg of dutasteride was administered orally once daily
280550|NCT01299571|E1|Reported Event|Avodart 0.5 mg|Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily
280551|NCT01299480|B6|Baseline|Total|Total of all reporting groups
280828|NCT01299285|O1|Outcome|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
280524|NCT01299610|O3|Outcome|Placebo|Eligible participants applied matching placebo to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280525|NCT01299610|O2|Outcome|GW870086, 2.0% Cream|Eligible participants applied GW870086, 2.0% cream to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280526|NCT01299610|O1|Outcome|GW870086, 0.2% Cream|Participants applied GW870086, 0.2% cream to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280527|NCT01299610|O4|Outcome|FP, 0.05% Cream|Eligible participants applied FP, 0.05% cream to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280528|NCT01299610|O3|Outcome|Placebo|Eligible participants applied matching placebo to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280529|NCT01299610|O2|Outcome|GW870086, 2.0% Cream|Eligible participants applied GW870086, 2.0% cream to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280530|NCT01299610|O1|Outcome|GW870086, 0.2% Cream|Participants applied GW870086, 0.2% cream to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280531|NCT01299610|O4|Outcome|FP, 0.05% Cream|Eligible participants applied FP, 0.05% cream to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280552|NCT01299480|B5|Baseline|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
280553|NCT01299480|B4|Baseline|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
280554|NCT01299480|B3|Baseline|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
280532|NCT01299610|O3|Outcome|Placebo|Eligible participants applied matching placebo to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280533|NCT01299610|O2|Outcome|GW870086, 2.0% Cream|Eligible participants applied GW870086, 2.0% cream to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280534|NCT01299610|O1|Outcome|GW870086, 0.2% Cream|Participants applied GW870086, 0.2% cream to a specific lesion located on the arms and/or legs every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280535|NCT01299610|E3|Reported Event|Treatment 3: GW870086 0.2%, FP 0.05% and Placebo|Participants applied GW870086, 0.2% cream, FP, 0.05% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280536|NCT01299610|E2|Reported Event|Treatment 2: GW870086 2.0%, FP 0.05% and Placebo|Participants applied GW870086, 2.0% cream, Fluticasone Propionate (FP) 0.05% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of pots, use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. Participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280537|NCT01299610|E1|Reported Event|Treatment 1: GW870086, 2.0%, GW870086, 0.2% and Placebo|Participants applied GW870086, 2.0% cream, GW870086, 0.2% cream and placebo cream to a separate specific lesion located on the arms and/or legs (one lesion per limb), applying same study treatment to the same lesion every day for 21±2 days. For first three days of the study, participants applied their randomly assigned treatments at the same time of day during the clinic visits and the study personnel supervised to ensure that the correct application procedures were followed. A full explanation was given to each participant regarding the labeling of the pots, the use of disposable gloves, the volume of cream to be used for each single application and the size of the area of skin to be treated. Participants applied their study treatments under supervision at the clinic on Days 7, 14 and 21 to allow accurately timed pharmacokinetic blood sampling and assessment of local tolerability. The participants applied their treatments at home on Day 4 to 6, Day 8 to 13 and Day 15 to 20.
280538|NCT01299584|B1|Baseline|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
280539|NCT01299584|P1|Participant Flow|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
280540|NCT01299584|O1|Outcome|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
280541|NCT01299584|O1|Outcome|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
280542|NCT01299584|O1|Outcome|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
280555|NCT01299480|B2|Baseline|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
280556|NCT01299480|B1|Baseline|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
280557|NCT01299480|P5|Participant Flow|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
280558|NCT01299480|P4|Participant Flow|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
280559|NCT01299480|P3|Participant Flow|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
280560|NCT01299480|P2|Participant Flow|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
280561|NCT01299480|P1|Participant Flow|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
280562|NCT01299480|O5|Outcome|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
280563|NCT01299480|O4|Outcome|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
280564|NCT01299480|O3|Outcome|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
280565|NCT01299480|O2|Outcome|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
280566|NCT01299480|O1|Outcome|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
280567|NCT01299480|O5|Outcome|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
280568|NCT01299480|O4|Outcome|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
280569|NCT01299480|O3|Outcome|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
280570|NCT01299480|O2|Outcome|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
280571|NCT01299480|O1|Outcome|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
280572|NCT01299480|O5|Outcome|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
280573|NCT01299480|O4|Outcome|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
280574|NCT01299480|O3|Outcome|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
280575|NCT01299480|O2|Outcome|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
280576|NCT01299480|O1|Outcome|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
280577|NCT01299480|O5|Outcome|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
280578|NCT01299480|O4|Outcome|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
280579|NCT01299480|O3|Outcome|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
280580|NCT01299480|O2|Outcome|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
280581|NCT01299480|O1|Outcome|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
280582|NCT01299480|O1|Outcome|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
280583|NCT01299480|O5|Outcome|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
280584|NCT01299480|O4|Outcome|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
280585|NCT01299480|O3|Outcome|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
280586|NCT01299480|O2|Outcome|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
280587|NCT01299480|O1|Outcome|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
280588|NCT01299480|O2|Outcome|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
280589|NCT01299480|O1|Outcome|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
280590|NCT01299480|E5|Reported Event|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
280591|NCT01299480|E4|Reported Event|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
280592|NCT01299480|E3|Reported Event|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
280593|NCT01299480|E2|Reported Event|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
280594|NCT01299480|E1|Reported Event|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
280596|NCT01299454|B4|Baseline|Normal Hepatic Function|Participants with normal hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280597|NCT01299454|B3|Baseline|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280598|NCT01299454|B2|Baseline|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280599|NCT01299454|B1|Baseline|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280600|NCT01299454|P4|Participant Flow|Normal Hepatic Function|Participants with normal hepatic function (based on Child-Pugh classification scheme) received a single dose of oral brexpiprazole 2 mg.
280601|NCT01299454|P3|Participant Flow|Severe Hepatic Impairment|Participants with severe hepatic impairment (based on Child-Pugh classification scheme) received a single dose of oral brexpiprazole 2 mg.
280602|NCT01299454|P2|Participant Flow|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme)received a single dose of oral brexpiprazole 2 mg.
280603|NCT01299454|P1|Participant Flow|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 milligrams (mg).
280604|NCT01299454|O4|Outcome|Normal Hepatic Function|Participants with normal hepatic function (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280605|NCT01299454|O3|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280606|NCT01299454|O2|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280607|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280608|NCT01299454|O4|Outcome|Normal Hepatic Function|Participants with normal hepatic function (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280609|NCT01299454|O3|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280610|NCT01299454|O2|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280611|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280612|NCT01299454|O4|Outcome|Normal Hepatic Function|Participants with normal hepatic function (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280613|NCT01299454|O3|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280614|NCT01299454|O2|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280615|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280616|NCT01299454|O4|Outcome|Normal Hepatic Function|Participants with normal hepatic function (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280617|NCT01299454|O3|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280618|NCT01299454|O2|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280619|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280620|NCT01299454|O4|Outcome|Normal Hepatic Function|Participants with normal hepatic function (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280621|NCT01299454|O3|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280622|NCT01299454|O2|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280623|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280624|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280625|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280626|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280627|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280628|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280629|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280630|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280631|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280632|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280633|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg
280634|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280635|NCT01299454|O1|Outcome|Mild Hepatic Function|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280636|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280637|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280638|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
280639|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280640|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280641|NCT01299454|O1|Outcome|Mild Hepatic Function|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280642|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280643|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280644|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280645|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280646|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280647|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280648|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280649|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280650|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
320542|NCT01193686|O1|Outcome|Veteran Peer Visitors|
280651|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280652|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280653|NCT01299454|O1|Outcome|Mild Hepatic Function|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280654|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280655|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280656|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
280657|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280658|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280659|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280660|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280661|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280662|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280663|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280664|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280665|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280666|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280667|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280668|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280669|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280670|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280671|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280672|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
323926|NCT01187550|B3|Baseline|Total|Total of all reporting groups
280673|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280674|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280675|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280676|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280677|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280678|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280679|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280680|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280681|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280682|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280683|NCT01299454|O1|Outcome|Mild Hepatic Function|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280684|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280685|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280686|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280687|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280688|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280689|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280690|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
280691|NCT01299454|O5|Outcome|Sever Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280692|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280693|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280694|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280695|NCT01299454|O1|Outcome|Mild Hepatic Function|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280696|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
280697|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280698|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
280699|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280700|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280701|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280702|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280703|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280704|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280705|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280706|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280707|NCT01299454|O1|Outcome|Mild Hepatic Function|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280708|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280709|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280710|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280711|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280712|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participants with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Partipants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280713|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280714|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280715|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280716|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280717|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280718|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280719|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280720|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280721|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280722|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280723|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280724|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280725|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280726|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant ith hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280727|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280728|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280729|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280730|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participant with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280731|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280732|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a particpant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280733|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with normal hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280734|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280735|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280736|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280737|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280738|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
280739|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280740|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280741|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280742|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280743|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280744|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
280745|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280746|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280747|NCT01299454|O3|Outcome|Moderate Hepatic Impairment.|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280748|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280749|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg
280750|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280751|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280752|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280753|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280754|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
280755|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280756|NCT01299454|E4|Reported Event|Normal Hepatic Function|Participants with normal hepatic function (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280757|NCT01299454|E3|Reported Event|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280758|NCT01299454|E2|Reported Event|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280759|NCT01299454|E1|Reported Event|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
280760|NCT01299389|B3|Baseline|Total|Total of all reporting groups
280761|NCT01299389|B2|Baseline|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64. Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
280791|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
280829|NCT01299285|O1|Outcome|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
280762|NCT01299389|B1|Baseline|Placebo (Double-blind)|Matching Placebo was given intramuscularly (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64. Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
280763|NCT01299389|P4|Participant Flow|Paliperidone Palmitate (Post-observational)|Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
280764|NCT01299389|P3|Participant Flow|Placebo (Post-observational)|Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
280765|NCT01299389|P2|Participant Flow|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
280766|NCT01299389|P1|Participant Flow|Placebo (Double-blind)|Matching Placebo was given intramuscularly (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64.
280767|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
280768|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
280769|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
280770|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
280771|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
280772|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
280773|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
280774|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
280775|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
280776|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
280777|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
280778|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
280779|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
280780|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularl (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64.
280781|NCT01299389|E4|Reported Event|Paliperidone Palmitate (Post-0bservational)|Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
280782|NCT01299389|E3|Reported Event|Placebo (Post-observational)|Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
280783|NCT01299389|E2|Reported Event|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
280784|NCT01299389|E1|Reported Event|Placebo (Double-blind)|Matching Placebo was given intramuscularly (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64.
280785|NCT01299376|B3|Baseline|Total|Total of all reporting groups
280786|NCT01299376|B2|Baseline|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
280787|NCT01299376|B1|Baseline|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
280788|NCT01299376|P2|Participant Flow|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
280789|NCT01299376|P1|Participant Flow|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
280790|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
280827|NCT01299285|O1|Outcome|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
280792|NCT01299376|O2|Outcome|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
280793|NCT01299376|O1|Outcome|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
280794|NCT01299376|O2|Outcome|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
280795|NCT01299376|O1|Outcome|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
280796|NCT01299376|O2|Outcome|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
280797|NCT01299376|O1|Outcome|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
280798|NCT01299376|O2|Outcome|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
280799|NCT01299376|O1|Outcome|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
280800|NCT01299376|O2|Outcome|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
280801|NCT01299376|O1|Outcome|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
280802|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
280803|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
280804|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
280805|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
280806|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
280807|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
280808|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
280809|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
280810|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
280811|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
280812|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
280813|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
280814|NCT01299376|E4|Reported Event|L50/H12.5→L50/H12.5/A5 - Extension|Participants who received L50/H12.5 combination tablet in double-blind treatment period and then received L50/H12.5/A5 orally once daily for 44 weeks in extension period.
280815|NCT01299376|E3|Reported Event|L50/H12.5/A5→L50/H12.5/A5 - Extension|Participants who received L50/H12.5/A5 combination tablet in double-blind treatment period and continued to receive L50/H12.5/A5 orally once daily for 44 weeks in extension period.
280816|NCT01299376|E2|Reported Event|L50/H12.5/A5 - Double Blind Treatment Period|Participants received L50/H12.5/A5 combination tablet, orally once daily for 8 weeks
280817|NCT01299376|E1|Reported Event|L50/H12.5- Double Blind Treatment Period|Participants received L50/H12.5 combination tablet, orally once daily for 8 weeks
280818|NCT01299285|B1|Baseline|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
280819|NCT01299285|P1|Participant Flow|LY3009104 (Baricitinib)|Single 10-milligram (mg) oral dose containing 100 microcuries of 14C-labeled LY3009104
280820|NCT01299285|O2|Outcome|LY3009104 Metabolites|The percentage of total radioactivity of all LY3009104 metabolites in the plasma after receiving a single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
280821|NCT01299285|O1|Outcome|LY3009104|The percentage of total radioactivity of LY3009104 (parent) in the plasma after receiving a single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
280822|NCT01299285|O1|Outcome|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
280823|NCT01299285|O1|Outcome|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
280824|NCT01299285|O1|Outcome|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
280825|NCT01299285|O1|Outcome|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
280826|NCT01299285|O1|Outcome|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
280830|NCT01299285|E1|Reported Event|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
280831|NCT01299272|B1|Baseline|All Enrolled Participants|All enrolled participants started on a flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for an additional 12 weeks. At 20 weeks, participants meeting criteria for randomization either 1) continued at their current dose of LY2216684 and SSRI, orally, QD, for an additional 24 weeks or 2) were switched from LY2216684 to Placebo and continued at their current SSRI dose, orally, QD, for an additional 24 weeks.
280832|NCT01299272|P4|Participant Flow|Placebo + SSRI (Double-blind Randomized Withdrawal Period)|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization were switched from LY2216684 to Placebo and continued at their current SSRI dose, orally, QD, for an additional 24 weeks.
280833|NCT01299272|P3|Participant Flow|LY2216684 + SSRI (Double-blind Randomized Withdrawal Period)|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization continued at their current dose of LY2216684 and SSRI, orally, QD, for an additional 24 weeks.
280834|NCT01299272|P2|Participant Flow|LY2216684 + SSRI (Stabilization Open-label Period)|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD for an additional 12 weeks.
280835|NCT01299272|P1|Participant Flow|LY2216684 + SSRI (Acute Open-label Period)|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI).
280836|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD for 12 weeks.
280837|NCT01299272|O2|Outcome|Placebo + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization were switched from LY2216684 to Placebo and continued at their current SSRI dose, orally, QD, for an additional 24 weeks.
280838|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization continued at their current dose of LY2216684 and SSRI, orally, QD, for an additional 24 weeks.
280839|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD for 12 weeks.
280840|NCT01299272|O2|Outcome|Placebo + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization were switched from LY2216684 to Placebo and continued at their current SSRI dose, orally, QD, for an additional 24 weeks.
280841|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization continued at their current dose of LY2216684 and SSRI, orally, QD, for an additional 24 weeks.
280842|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD for 12 weeks.
280843|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD for 12 weeks.
280844|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD for 12 weeks.
280845|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD for 12 weeks.
280846|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD for 12 weeks.
280847|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI).
280992|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
280848|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD for 12 weeks.
280849|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI).
280850|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD for 12 weeks.
280851|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI).
280852|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD for 12 weeks.
280853|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI).
280854|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD for 12 weeks.
280855|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI).
280856|NCT01299272|O2|Outcome|Placebo + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization were switched from LY2216684 to Placebo and continued at their current SSRI dose, orally, QD, for an additional 24 weeks.
280857|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization continued at their current dose of LY2216684 and SSRI, orally, QD, for an additional 24 weeks.
280858|NCT01299272|O2|Outcome|Placebo + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization were switched from LY2216684 to Placebo and continued at their current SSRI dose, orally, QD, for an additional 24 weeks.
280859|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization continued at their current dose of LY2216684 and SSRI, orally, QD, for an additional 24 weeks.
280860|NCT01299272|O2|Outcome|Placebo + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization were switched from LY2216684 to Placebo and continued at their current SSRI dose, orally, QD, for an additional 24 weeks.
280861|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization continued at their current dose of LY2216684 and SSRI, orally, QD, for an additional 24 weeks.
280862|NCT01299272|O2|Outcome|Placebo + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization were switched from LY2216684 to Placebo and continued at their current SSRI dose, orally, QD, for an additional 24 weeks.
280863|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization continued at their current dose of LY2216684 and SSRI, orally, QD, for an additional 24 weeks.
280864|NCT01299272|O2|Outcome|Placebo + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization were switched from LY2216684 to Placebo and continued at their current SSRI dose, orally, QD, for an additional 24 weeks.
280865|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization continued at their current dose of LY2216684 and SSRI, orally, QD, for an additional 24 weeks.
281727|NCT01296672|E1|Reported Event|Finasteride|Finasteride 5mg every day by mouth for 3 months
280866|NCT01299272|O2|Outcome|Placebo + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization were switched from LY2216684 to Placebo and continued at their current SSRI dose, orally, QD, for an additional 24 weeks.
280867|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization continued at their current dose of LY2216684 and SSRI, orally, QD, for an additional 24 weeks.
280868|NCT01299272|O2|Outcome|Placebo + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization were switched from LY2216684 to Placebo and continued at their current SSRI dose, orally, QD, for an additional 24 weeks.
280869|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization continued at their current dose of LY2216684 and SSRI, orally, QD, for an additional 24 weeks.
280870|NCT01299272|O2|Outcome|Placebo + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization were switched from LY2216684 to Placebo and continued at their current SSRI dose, orally, QD, for an additional 24 weeks.
280871|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization continued at their current dose of LY2216684 and SSRI, orally, QD, for an additional 24 weeks.
280872|NCT01299272|O2|Outcome|Placebo + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization were switched from LY2216684 to Placebo and continued at their current SSRI dose, orally, QD, for an additional 24 weeks.
280873|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization continued at their current dose of LY2216684 and SSRI, orally, QD, for an additional 24 weeks.
280874|NCT01299272|O2|Outcome|Placebo + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization were switched from LY2216684 to Placebo and continued at their current SSRI dose, orally, QD, for an additional 24 weeks.
280875|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization continued at their current dose of LY2216684 and SSRI, orally, QD, for an additional 24 weeks.
280876|NCT01299272|O2|Outcome|Placebo + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization were switched from LY2216684 to Placebo and continued at their current SSRI dose, orally, QD, for an additional 24 weeks.
280877|NCT01299272|O1|Outcome|LY2216684 + SSRI|Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). At 8 weeks, participants meeting remission criteria continued on the same, stable dose of LY2216684 and SSRI, orally, QD, for 12 weeks. At 20 weeks, participants meeting criteria for randomization continued at their current dose of LY2216684 and SSRI, orally, QD, for an additional 24 weeks.
280878|NCT01299272|E8|Reported Event|LY2216684 + SSRI (Nonrandomized Abrupt Discontinuation Period)|"Placebo, orally, once daily (QD) for 2 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI).~Includes all non-randomized participants who discontinued early from either Open-label Period and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation Period visit."
280879|NCT01299272|E7|Reported Event|Placebo + SSRI (Abrupt Discontinuation Period)|"Placebo, orally, once daily (QD) for 2 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI).~Includes all randomized participants who discontinued placebo after completion of or early withdrawal from the Double-blind Randomized Withdrawal Period and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation Period visit."
280880|NCT01299272|E6|Reported Event|LY2216684 + SSRI (Randomized Abrupt Discontinuation Period)|"Placebo, orally, once daily (QD) for 2 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI).~Includes all randomized participants who abruptly discontinued LY2216684 after completion of or early withdrawal from the Double-blind Randomized Withdrawal Period and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation Period visit."
281728|NCT01296646|B3|Baseline|Total|Total of all reporting groups
280881|NCT01299272|E5|Reported Event|LY2216684 + SSRI (Randomized Tapered Discontinuation Period)|"12 milligrams (mg) LY2216684 for 4 days, 6 mg LY2216684 for 4 days, then placebo for 6 days, orally, once daily (QD), adjunctive to a selective serotonin reuptake inhibitor (SSRI).~Includes all randomized participants who tapered discontinuation of LY2216684 after completion of or early withdrawal from the Double-blind Randomized Withdrawal Period and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation Period visit."
280882|NCT01299272|E4|Reported Event|Placebo + SSRI (Double-blind Randomized Withdrawal Period)|"Placebo, orally, once daily (QD) for 24 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI).~Includes randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Double-blind Randomized Withdrawal Period."
280883|NCT01299272|E3|Reported Event|LY2216684 + SSRI (Double-blind Randomized Withdrawal Period)|"Same, stable dose of LY2216684 as in the Stabilization Open-label Period, orally, once daily (QD) for 24 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI).~Includes randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Double-blind Randomized Withdrawal Period."
280884|NCT01299272|E2|Reported Event|LY2216684 + SSRI (Stabilization Open-label Period)|"Same, stable dose of LY2216684 as in the Acute Open-label Period, orally, once daily (QD) for 12 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI).~Includes all participants who completed the Acute Open-label Period and did not discontinue for the reason 'Lost to Follow-up' at the first post-baseline visit during the Stabilization Open-label Period."
280885|NCT01299272|E1|Reported Event|LY2216684 + SSRI (Acute Open-label Period)|"Flexible dose of 12 or 18 milligrams (mg) LY2216684, administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI).~Includes all enrolled participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-baseline visit during the Acute Open-label Period."
280886|NCT01299116|B4|Baseline|Total|Total of all reporting groups
280887|NCT01299116|B3|Baseline|Randomized SARC|"Participants received one of a variety of oral contraceptives or DMPA~DMPA: Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®.~oral contraceptives: Oral contraceptives (any variety of formulations are permitted)"
280888|NCT01299116|B2|Baseline|Randomized LARC|"Participants receive one of the following interventions:~Implanon® or Nexplanon®; ParaGard®; Mirena®~Implanon®: Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel)~ParaGard®: Intrauterine device marketed in the US as ParaGard® (a T-shaped plastic device containing 380mm2 of copper surface)~Mirena®: Intrauterine system, marketed in the US as Mirena® (containing 52 mg of levonorgestrel)"
280889|NCT01299116|B1|Baseline|Preference SARC|"Participants received one of a variety of oral contraceptives or DMPA~DMPA: Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®.~oral contraceptives: Oral contraceptives (any variety of formulations are permitted)"
280890|NCT01299116|P3|Participant Flow|SARC - Randomized|"Participants received one of a variety of oral contraceptives or DMPA~DMPA: Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®."
280891|NCT01299116|P2|Participant Flow|LARC - Randomized|"Participants receive one of the following interventions:~Implanon® or Nexplanon®; ParaGard®; Mirena®~Implanon®: Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel)~ParaGard®: Intrauterine device marketed in the US as ParaGard® (a T-shaped plastic device containing 380mm2 of copper surface)~Mirena®: Intrauterine system, marketed in the US as Mirena® (containing 52 mg of levonorgestrel)"
280892|NCT01299116|P1|Participant Flow|SARC - Preference|"Participants received one of a variety of oral contraceptives or DMPA~DMPA: Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®.~oral contraceptives: Oral contraceptives (any variety of formulations are permitted)"
280893|NCT01299116|O3|Outcome|Randomized SARC|"Participants received one of a variety of oral contraceptives or DMPA~DMPA: Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®.~oral contraceptives: Oral contraceptives (any variety of formulations are permitted)"
280894|NCT01299116|O2|Outcome|Randomized LARC|"Participants receive one of the following interventions:~Implanon® or Nexplanon®; ParaGard®; Mirena®~Implanon®: Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel)~ParaGard®: Intrauterine device marketed in the US as ParaGard® (a T-shaped plastic device containing 380mm2 of copper surface)~Mirena®: Intrauterine system, marketed in the US as Mirena® (containing 52 mg of levonorgestrel)"
280895|NCT01299116|O1|Outcome|Preference SARC|"Participants received one of a variety of oral contraceptives or DMPA~DMPA: Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®.~oral contraceptives: Oral contraceptives (any variety of formulations are permitted)"
280896|NCT01299116|O3|Outcome|SARC - Randomized|"Participants received one of a variety of oral contraceptives or DMPA~DMPA: Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®."
280897|NCT01299116|O2|Outcome|LARC - Randomized|"Participants receive one of the following interventions:~Implanon® or Nexplanon®; ParaGard®; Mirena®~Implanon®: Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel)~ParaGard®: Intrauterine device marketed in the US as ParaGard® (a T-shaped plastic device containing 380mm2 of copper surface)~Mirena®: Intrauterine system, marketed in the US as Mirena® (containing 52 mg of levonorgestrel)"
280898|NCT01299116|O1|Outcome|SARC - Preference|"Participants received one of a variety of oral contraceptives or DMPA~DMPA: Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®.~oral contraceptives: Oral contraceptives (any variety of formulations are permitted)"
281729|NCT01296646|B2|Baseline|Naltrexone|50 mg of naltrexone orally daily.
280899|NCT01299116|O3|Outcome|SARC - Randomized|"Participants received one of a variety of oral contraceptives or DMPA~DMPA: Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®."
280900|NCT01299116|O2|Outcome|LARC - Randomized|"Participants receive one of the following interventions:~Implanon® or Nexplanon®; ParaGard®; Mirena®~Implanon®: Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel)~ParaGard®: Intrauterine device marketed in the US as ParaGard® (a T-shaped plastic device containing 380mm2 of copper surface)~Mirena®: Intrauterine system, marketed in the US as Mirena® (containing 52 mg of levonorgestrel)"
280901|NCT01299116|O1|Outcome|SARC - Preference|"Participants received one of a variety of oral contraceptives or DMPA~DMPA: Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®.~oral contraceptives: Oral contraceptives (any variety of formulations are permitted)"
280902|NCT01299116|E3|Reported Event|SARC - Randomized|"Participants received one of a variety of oral contraceptives or DMPA~DMPA: Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®."
280903|NCT01299116|E2|Reported Event|LARC - Randomized|"Participants receive one of the following interventions:~Implanon® or Nexplanon®; ParaGard®; Mirena®~Implanon®: Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel)~ParaGard®: Intrauterine device marketed in the US as ParaGard® (a T-shaped plastic device containing 380mm2 of copper surface)~Mirena®: Intrauterine system, marketed in the US as Mirena® (containing 52 mg of levonorgestrel)"
280904|NCT01299116|E1|Reported Event|SARC - Preference|"Participants received one of a variety of oral contraceptives or DMPA~DMPA: Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®.~oral contraceptives: Oral contraceptives (any variety of formulations are permitted)"
280905|NCT01299103|B4|Baseline|Total|Total of all reporting groups
280906|NCT01299103|B3|Baseline|Triple Treatment|Pelleve Wrinkle Treatment System: comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System
280907|NCT01299103|B2|Baseline|Double Treatment|Pelleve Wrinkle Treatment System: comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System
280908|NCT01299103|B1|Baseline|Single Treatment|Pelleve Wrinkle Treatment System: comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System
280909|NCT01299103|P3|Participant Flow|Triple Treatment|Subjects receive three treatments
280910|NCT01299103|P2|Participant Flow|Double Treatment|Subjects receive two treatments
280911|NCT01299103|P1|Participant Flow|Single Treatment|Subjects receive one treatment
280912|NCT01299103|O3|Outcome|Triple Treatment|Subjects receive three treatments
280913|NCT01299103|O2|Outcome|Double Treatment|Subjects receive two treatments
280914|NCT01299103|O1|Outcome|Single Treatment|Subjects receive one treatment
280915|NCT01299103|O3|Outcome|Triple Treatment|Subjects receive three treatments
280916|NCT01299103|O2|Outcome|Double Treatment|Subjects receive two treatments
280917|NCT01299103|O1|Outcome|Single Treatment|Subjects receive one treatment
280918|NCT01299103|E3|Reported Event|Triple Treatment|Subjects receive three treatments
280919|NCT01299103|E2|Reported Event|Double Treatment|Subjects receive two treatments
280920|NCT01299103|E1|Reported Event|Single Treatment|Subjects receive one treatment
280921|NCT01299090|B1|Baseline|Treatment Group|"All subjects enrolled were in the treatment group.~Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart"
280922|NCT01299090|P1|Participant Flow|Treatment Group|"All subjects enrolled were in the treatment group.~Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart"
280923|NCT01299090|O1|Outcome|Treatment Group|"All subjects enrolled were in the treatment group.~Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart"
280924|NCT01299090|O1|Outcome|Treatment Group|"All subjects enrolled were in the treatment group.~Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart"
280925|NCT01299090|E1|Reported Event|Treatment Group|"All subjects enrolled were in the treatment group.~Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart"
280926|NCT01299077|B1|Baseline|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
280927|NCT01299077|P1|Participant Flow|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
280928|NCT01299077|O1|Outcome|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
280929|NCT01299077|O1|Outcome|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
280930|NCT01299077|O1|Outcome|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
281730|NCT01296646|B1|Baseline|Placebo|Placebo taken once daily.
280931|NCT01299077|O1|Outcome|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
280932|NCT01299077|O1|Outcome|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
280933|NCT01299077|E1|Reported Event|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
280934|NCT01299025|B3|Baseline|Total|Total of all reporting groups
280935|NCT01299025|B2|Baseline|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week~Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
280936|NCT01299025|B1|Baseline|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
280937|NCT01299025|P2|Participant Flow|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week~Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
280938|NCT01299025|P1|Participant Flow|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
280939|NCT01299025|O2|Outcome|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week~Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
280940|NCT01299025|O1|Outcome|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
280941|NCT01299025|O2|Outcome|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week~Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
280942|NCT01299025|O1|Outcome|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
280943|NCT01299025|O2|Outcome|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week~Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
280944|NCT01299025|O1|Outcome|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
280945|NCT01299025|O2|Outcome|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week~Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
280946|NCT01299025|O1|Outcome|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
280947|NCT01299025|E2|Reported Event|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week~Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
280948|NCT01299025|E1|Reported Event|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
280949|NCT01298778|B3|Baseline|Total|Total of all reporting groups
280950|NCT01298778|B2|Baseline|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
280951|NCT01298778|B1|Baseline|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
280952|NCT01298778|P2|Participant Flow|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
280953|NCT01298778|P1|Participant Flow|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
280954|NCT01298778|O2|Outcome|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
280955|NCT01298778|O1|Outcome|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
280956|NCT01298778|O2|Outcome|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
280957|NCT01298778|O1|Outcome|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
280958|NCT01298778|O2|Outcome|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
280993|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
280994|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
280959|NCT01298778|O1|Outcome|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
280960|NCT01298778|O2|Outcome|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses~Duramorph 300: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
280961|NCT01298778|O1|Outcome|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph 150: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
280962|NCT01298778|O2|Outcome|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
280963|NCT01298778|O1|Outcome|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
280964|NCT01298778|O2|Outcome|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
280965|NCT01298778|O1|Outcome|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
280966|NCT01298778|O2|Outcome|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
280967|NCT01298778|O1|Outcome|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
280968|NCT01298778|O2|Outcome|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
280969|NCT01298778|O1|Outcome|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
280970|NCT01298778|E2|Reported Event|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
280971|NCT01298778|E1|Reported Event|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
280972|NCT01298661|B4|Baseline|Total|Total of all reporting groups
280973|NCT01298661|B3|Baseline|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
280974|NCT01298661|B2|Baseline|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
280975|NCT01298661|B1|Baseline|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
280976|NCT01298661|P3|Participant Flow|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
280977|NCT01298661|P2|Participant Flow|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
280978|NCT01298661|P1|Participant Flow|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
280979|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
280980|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
280981|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
280982|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
280983|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
280984|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
280985|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
280986|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
280987|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
280988|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
280989|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
280990|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
280991|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
324083|NCT01187446|B3|Baseline|Total|Total of all reporting groups
280995|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
280996|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
280997|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
280998|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
280999|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
281000|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
281001|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
281002|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
281003|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
281004|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
281005|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
281006|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
281007|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
281008|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
281009|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
281010|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
281011|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
281012|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
281013|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
281014|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
281015|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
281016|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
281017|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
281018|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
281019|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
281020|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
281021|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
281022|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
281023|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
281024|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
281025|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
281026|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
281027|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
281028|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
281029|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
281030|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
281031|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
281032|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
281033|NCT01298661|O1|Outcome|COPD Patients|Patients with clinical and spirometrical diagnosis of Chronic Obstructive Pulmonary Disease
281034|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
281035|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
281036|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
281037|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
281038|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
281039|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
281040|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
281041|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
281042|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
281043|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
281044|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
281045|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
281046|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
281047|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
281048|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
281049|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
281050|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
281051|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
281052|NCT01298661|E3|Reported Event|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
281053|NCT01298661|E2|Reported Event|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
281054|NCT01298661|E1|Reported Event|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
281055|NCT01298648|B1|Baseline|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
281056|NCT01298648|P1|Participant Flow|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
281057|NCT01298648|O1|Outcome|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
281058|NCT01298648|O1|Outcome|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
281059|NCT01298648|O1|Outcome|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
281060|NCT01298648|O1|Outcome|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
281061|NCT01298648|O1|Outcome|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
281062|NCT01298648|O1|Outcome|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
281063|NCT01298648|E1|Reported Event|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
281064|NCT01298570|B3|Baseline|Total|Total of all reporting groups
281065|NCT01298570|B2|Baseline|Arm B|"Placebo + FOLFIRI~Placebo: Placebo, oral administration, Days 4-10 and Days 18-24 of 28 day cycle +~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle."
281066|NCT01298570|B1|Baseline|Arm A|"regorafenib 160 mg + FOLFIRI~Regorafenib (BAY 73-4506): Regorafenib, 160 mg, PO, daily, per 7 day cycle~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle."
281067|NCT01298570|P2|Participant Flow|Arm B|"Placebo + FOLFIRI~Placebo: Placebo, oral administration, Days 4-10 and Days 18-24 of 28 day cycle +~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle."
281068|NCT01298570|P1|Participant Flow|Arm A|"regorafenib 160 mg + FOLFIRI~Regorafenib (BAY 73-4506): Regorafenib, 160 mg, PO, daily, per 7 day cycle~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle."
281069|NCT01298570|O2|Outcome|Arm B|"Placebo + FOLFIRI~Placebo: Placebo, oral administration, Days 4-10 and Days 18-24 of 28 day cycle +~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle."
281070|NCT01298570|O1|Outcome|Arm A|"regorafenib 160 mg + FOLFIRI~Regorafenib (BAY 73-4506): Regorafenib, 160 mg, PO, daily, per 7 day cycle~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle."
281071|NCT01298570|O2|Outcome|Arm B|"Placebo + FOLFIRI~Placebo: Placebo, oral administration, Days 4-10 and Days 18-24 of 28 day cycle +~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle."
281072|NCT01298570|O1|Outcome|Arm A|"regorafenib 160 mg + FOLFIRI~Regorafenib (BAY 73-4506): Regorafenib, 160 mg, PO, daily, per 7 day cycle~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle."
281073|NCT01298570|O2|Outcome|Arm B|"Placebo + FOLFIRI~Placebo: Placebo, oral administration, Days 4-10 and Days 18-24 of 28 day cycle +~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle."
281074|NCT01298570|O1|Outcome|Arm A|"regorafenib 160 mg + FOLFIRI~Regorafenib (BAY 73-4506): Regorafenib, 160 mg, PO, daily, per 7 day cycle~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle."
281075|NCT01298570|O2|Outcome|Arm B|"Placebo + FOLFIRI~Placebo: Placebo, oral administration, Days 4-10 and Days 18-24 of 28 day cycle +~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle."
281076|NCT01298570|O1|Outcome|Arm A|"regorafenib 160 mg + FOLFIRI~Regorafenib (BAY 73-4506): Regorafenib, 160 mg, PO, daily, per 7 day cycle~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle."
281077|NCT01298570|O2|Outcome|Arm B|"Placebo + FOLFIRI~Placebo: Placebo, oral administration, Days 4-10 and Days 18-24 of 28 day cycle +~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle."
281078|NCT01298570|O1|Outcome|Arm A|"regorafenib 160 mg + FOLFIRI~Regorafenib (BAY 73-4506): Regorafenib, 160 mg, PO, daily, per 7 day cycle~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle."
281079|NCT01298570|O2|Outcome|Arm B|"Placebo + FOLFIRI~Placebo: Placebo, oral administration, Days 4-10 and Days 18-24 of 28 day cycle +~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle."
281080|NCT01298570|O1|Outcome|Arm A|"regorafenib 160 mg + FOLFIRI~Regorafenib (BAY 73-4506): Regorafenib, 160 mg, PO, daily, per 7 day cycle~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle."
281081|NCT01298570|E2|Reported Event|Arm B|"Placebo + FOLFIRI~Placebo: Placebo, oral administration, Days 4-10 and Days 18-24 of 28 day cycle +~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle."
281082|NCT01298570|E1|Reported Event|Arm A|"regorafenib 160 mg + FOLFIRI~Regorafenib (BAY 73-4506): Regorafenib, 160 mg, PO, daily, per 7 day cycle~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle."
281083|NCT01298544|B1|Baseline|Entire Study Population|All randomized participants
281084|NCT01298544|P1|Participant Flow|Entire Study Population|All randomized participants
281085|NCT01298544|O3|Outcome|DTaP Alone|No investigational product was administered during the study. Participants previously received DTaP in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), and 5 months (vaccination 3).
281086|NCT01298544|O2|Outcome|7vPnC and DTaP|No investigational product was administered during the study. Participants previously received 7vPnC concomitantly with diphtheria, tetanus, and acellular pertussis vaccine (DTaP) in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age.
281087|NCT01298544|O1|Outcome|7vPnC|No investigational product was administered during the study. Participants previously received 7-valent pneumococcal conjugate vaccine (7vPnC) in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age.
281088|NCT01298544|O3|Outcome|DTaP Alone|No investigational product was administered during the study. Participants previously received DTaP in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), and 5 months (vaccination 3).
281089|NCT01298544|O2|Outcome|7vPnC and DTaP|No investigational product was administered during the study. Participants previously received 7vPnC concomitantly with diphtheria, tetanus, and acellular pertussis vaccine (DTaP) in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age.
281090|NCT01298544|O1|Outcome|7vPnC|No investigational product was administered during the study. Participants previously received 7-valent pneumococcal conjugate vaccine (7vPnC) in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age.
281091|NCT01298544|E1|Reported Event|Entire Study Population|All randomized participants
281092|NCT01298531|B3|Baseline|Total|Total of all reporting groups
281093|NCT01298531|B2|Baseline|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281094|NCT01298531|B1|Baseline|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281095|NCT01298531|P2|Participant Flow|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281096|NCT01298531|P1|Participant Flow|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281097|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281098|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281099|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281100|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281101|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281102|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281103|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281104|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281105|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281106|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281107|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281108|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281109|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281110|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281111|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281112|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281396|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
281113|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281114|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281115|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281116|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281117|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281118|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281119|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281120|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281121|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281122|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281123|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281124|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281125|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281126|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281127|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281128|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281129|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281130|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281131|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281132|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281133|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281134|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281135|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281136|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281137|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281138|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281139|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281140|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281141|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281142|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281143|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281144|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281145|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281146|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281147|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281731|NCT01296646|P2|Participant Flow|Naltrexone|50 mg of naltrexone orally daily.
281148|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281149|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281150|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281151|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281152|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281153|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281154|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281155|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281156|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281157|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281158|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281159|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281160|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281161|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281162|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281163|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281164|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281165|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281166|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281167|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281168|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281169|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281170|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281171|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281172|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281173|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281174|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281175|NCT01298531|O1|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281176|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281177|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281178|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281179|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281180|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281181|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281182|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281397|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
281183|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281184|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281185|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281186|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281187|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281188|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281189|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281190|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281191|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281192|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281193|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281194|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281195|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281196|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281197|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281198|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281199|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281200|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281201|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281202|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281203|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281204|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281205|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281206|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281207|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281208|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281209|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281210|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281211|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281212|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281213|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281214|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281215|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281216|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281217|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281439|NCT01297491|B3|Baseline|Total|Total of all reporting groups
281218|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281219|NCT01298531|E2|Reported Event|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
281220|NCT01298531|E1|Reported Event|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
281221|NCT01298518|B4|Baseline|Total|Total of all reporting groups
281222|NCT01298518|B3|Baseline|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
281223|NCT01298518|B2|Baseline|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
281224|NCT01298518|B1|Baseline|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
281225|NCT01298518|P3|Participant Flow|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
281226|NCT01298518|P2|Participant Flow|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
281227|NCT01298518|P1|Participant Flow|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
281228|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
281229|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
281230|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
281231|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
281232|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
281233|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
281234|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
281235|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
281236|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
281237|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
281238|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
281239|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
281240|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
281241|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
281242|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
281243|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
281244|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
281245|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
281246|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
281247|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
281248|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
281249|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
281250|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
281251|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
281252|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
281315|NCT01298167|B2|Baseline|FAG Superior ½ of Wound & Cyanoacrylate Inferior ½ of Wound|Patients wounds were divided in half and Fast Acting Gut Suture was utilized for the superior ½ of the wound & Cyanoacrylate was utilized for inferior ½ of wound.
281253|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
281254|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
281255|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
281256|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
281257|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
281258|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
281259|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
281260|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
281261|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
281262|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
281263|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
281264|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
281265|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
281266|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
281267|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
281268|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
281269|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
281270|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
281271|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
281272|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
281273|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
281274|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
281275|NCT01298518|E3|Reported Event|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
281276|NCT01298518|E2|Reported Event|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
281277|NCT01298518|E1|Reported Event|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
281278|NCT01298492|B1|Baseline|PF-00547659 75 mg|Participants received PF-00547659 75 mg subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant.
281279|NCT01298492|P1|Participant Flow|PF-00547659 75 mg|Participants received PF-00547659 75 milligram (mg) subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant.
281280|NCT01298492|O1|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 mg subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant.
281281|NCT01298492|O1|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 mg subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant.
281395|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
281282|NCT01298492|O1|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 mg subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant.
281283|NCT01298492|E1|Reported Event|PF-00547659 75 mg|Participants received PF-00547659 75 mg subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant.
281284|NCT01298362|B3|Baseline|Total|Total of all reporting groups
281285|NCT01298362|B2|Baseline|HT Cohort|Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
281286|NCT01298362|B1|Baseline|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
281287|NCT01298362|P2|Participant Flow|HT Cohort|Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
281288|NCT01298362|P1|Participant Flow|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
281289|NCT01298362|O2|Outcome|HT Cohort|In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
281290|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
281291|NCT01298362|O2|Outcome|HT Cohort|In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
281292|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
281293|NCT01298362|O2|Outcome|HT Cohort|Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
281294|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
281295|NCT01298362|O2|Outcome|HT Cohort|In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
281296|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
281297|NCT01298362|O2|Outcome|HT Cohort|In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
281298|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
281299|NCT01298362|O2|Outcome|HT Cohort|In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
281300|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
281301|NCT01298362|O2|Outcome|HT Cohort|"In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.~The primary outcome variable was the mean percentage change in LS BMD between the pre CT treatment measurement and the post 12 months AI measurements in the CT cohort. The HT cohort was included as a control group.~BMD measurements in HT cohort were taken before AI start and at 12 months."
281302|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
281303|NCT01298362|E2|Reported Event|HT Cohort|Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
281304|NCT01298362|E1|Reported Event|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
281305|NCT01298323|B3|Baseline|Total|Total of all reporting groups
281306|NCT01298323|B2|Baseline|Vandetanib 300mg + Outreach Program|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
281307|NCT01298323|B1|Baseline|Vandetanib 300mg|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
281308|NCT01298323|P2|Participant Flow|Vandetanib 300mg + Outreach Program|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
281309|NCT01298323|P1|Participant Flow|Vandetanib 300mg|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
281310|NCT01298323|O2|Outcome|Vandetanib 300 mg|Patients on this arm will get a standard AE monitoring schedule, similar to that used on previous studies. Patients will be asked about any AEs at scheduled visits and will have the option to contact the investigator at any time if experiencing any AE or symptoms and discuss the best treatment options.
281311|NCT01298323|O1|Outcome|Vandetanib 300 mg+Outreach Program|Patients on this arm will be contacted by site personnel at week 1 and then every 2 weeks during the first 52 weeks on the study (or prior discontinuation) to detect and possibly treat adverse events sooner than they might have been without the patient outreach, and at a time of lesser CTCAE grade.
281312|NCT01298323|E2|Reported Event|Vandetanib 300mg + Outreach Program|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
281313|NCT01298323|E1|Reported Event|Vandetanib 300mg|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
281314|NCT01298167|B3|Baseline|Total|Total of all reporting groups
281316|NCT01298167|B1|Baseline|Cyanoacrylate Superior ½ of Wound & FAG Inferior ½ of Wound|Patients wounds were divided in half and Cyanoacrylate was utilized for the superior ½ of the wound & Fast Acting Gut Suture was utilized for inferior ½ of wound.
281317|NCT01298167|P2|Participant Flow|FAG Superior ½ of Wound & Cyanoacrylate Inferior ½ of Wound|Patients wounds were divided in half and Fast Acting Gut Suture was utilized for the superior ½ of the wound & Cyanoacrylate was utilized for inferior ½ of wound.
281318|NCT01298167|P1|Participant Flow|Cyanoacrylate Superior ½ of Wound & FAG Inferior ½ of Wound|Patients wounds were divided in half and Cyanoacrylate was utilized for the superior ½ of the wound & Fast Acting Gut Suture was utilized for inferior ½ of wound.
281319|NCT01298167|O2|Outcome|FAG Superior/Inferior|Combined measures of Fast Absorbing Gut Suture used on both the superior and inferior halves of wounds.
281320|NCT01298167|O1|Outcome|Cyanoacrylate Superior/Inferior|Combined measures of Cyanoacrylate used on both the superior and inferior halves of wounds.
281321|NCT01298167|E2|Reported Event|FAG Superior ½ of Wound & Cyanoacrylate Inferior ½ of Wound|Patients wounds were divided in half and Fast Acting Gut Suture was utilized for the superior ½ of the wound & Cyanoacrylate was utilized for inferior ½ of wound.
281322|NCT01298167|E1|Reported Event|Cyanoacrylate Superior ½ of Wound & FAG Inferior ½ of Wound|Patients wounds were divided in half and Cyanoacrylate was utilized for the superior ½ of the wound & Fast Acting Gut Suture was utilized for inferior ½ of wound.
281323|NCT01298128|B3|Baseline|Total|Total of all reporting groups
281324|NCT01298128|B2|Baseline|Combined Oral Contraceptive Pill|OCP for IVF pre-treatment
281325|NCT01298128|B1|Baseline|NuvaRing|NuvaRing for IVF pre-treatment
281326|NCT01298128|P2|Participant Flow|Combined Oral Contraceptive Pill|OCP for IVF pre-treatment
281327|NCT01298128|P1|Participant Flow|NuvaRing|NuvaRing for IVF pre-treatment
281328|NCT01298128|O2|Outcome|Combined Oral Contraceptive Pill|OCP for IVF pre-treatment
281329|NCT01298128|O1|Outcome|NuvaRing|NuvaRing for IVF pre-treatment
281330|NCT01298128|E2|Reported Event|Combined Oral Contraceptive Pill|OCP for IVF pre-treatment
281331|NCT01298128|E1|Reported Event|NuvaRing|NuvaRing for IVF pre-treatment
281332|NCT01298063|B6|Baseline|Total|Total of all reporting groups
281333|NCT01298063|B5|Baseline|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
281334|NCT01298063|B4|Baseline|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
281335|NCT01298063|B3|Baseline|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
281336|NCT01298063|B2|Baseline|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
281337|NCT01298063|B1|Baseline|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 mg Afatinib (One tablet qd in the morning).
281338|NCT01298063|P5|Participant Flow|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
281339|NCT01298063|P4|Participant Flow|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
281340|NCT01298063|P3|Participant Flow|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
281341|NCT01298063|P2|Participant Flow|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
281342|NCT01298063|P1|Participant Flow|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 milligram (mg) Afatinib (One tablet qd in the morning).
281343|NCT01298063|O5|Outcome|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
281344|NCT01298063|O4|Outcome|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
281345|NCT01298063|O3|Outcome|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
281346|NCT01298063|O2|Outcome|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
281347|NCT01298063|O1|Outcome|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 mg Afatinib (One tablet qd in the morning).
281348|NCT01298063|O5|Outcome|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
281349|NCT01298063|O4|Outcome|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
281350|NCT01298063|O3|Outcome|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
281351|NCT01298063|O2|Outcome|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
281352|NCT01298063|O1|Outcome|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 mg Afatinib (One tablet qd in the morning).
281353|NCT01298063|O5|Outcome|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
281354|NCT01298063|O4|Outcome|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
281355|NCT01298063|O3|Outcome|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
281512|NCT01297322|B3|Baseline|Total|Total of all reporting groups
281356|NCT01298063|O2|Outcome|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
281357|NCT01298063|O1|Outcome|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 mg Afatinib (One tablet qd in the morning).
281358|NCT01298063|O5|Outcome|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
281359|NCT01298063|O4|Outcome|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
281360|NCT01298063|O3|Outcome|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
281361|NCT01298063|O2|Outcome|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
281362|NCT01298063|O1|Outcome|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 milligram (mg) Afatinib (One tablet qd in the morning).
281363|NCT01298063|E5|Reported Event|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
281364|NCT01298063|E4|Reported Event|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
281365|NCT01298063|E3|Reported Event|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
281366|NCT01298063|E2|Reported Event|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
281367|NCT01298063|E1|Reported Event|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 mg Afatinib (One tablet qd in the morning).
281368|NCT01297920|B4|Baseline|Total|Total of all reporting groups
281369|NCT01297920|B3|Baseline|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
281370|NCT01297920|B2|Baseline|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months
281371|NCT01297920|B1|Baseline|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months
281372|NCT01297920|P3|Participant Flow|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
281373|NCT01297920|P2|Participant Flow|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months
281374|NCT01297920|P1|Participant Flow|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months
281375|NCT01297920|O3|Outcome|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
281376|NCT01297920|O2|Outcome|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months
281377|NCT01297920|O1|Outcome|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months
281378|NCT01297920|E3|Reported Event|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
281379|NCT01297920|E2|Reported Event|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months
281380|NCT01297920|E1|Reported Event|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months
281381|NCT01297595|B1|Baseline|Entire Study Population|Includes participants randomized to receive crizotinib 250 mg FC first and crizotinib 250 mg OLF first.
281382|NCT01297595|P2|Participant Flow|Crizotinib 250 mg OLF First, Then Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg OLF in first intervention period; and single oral dose of crizotinib 250 mg FC in second intervention period. A washout period of at least 14 days was maintained between each crizotinib dose.
281383|NCT01297595|P1|Participant Flow|Crizotinib 250 mg FC First, Then Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 milligram (mg) formulated capsule (FC) in first intervention period; and single oral dose of crizotinib 250 mg oral liquid formulation (OLF) in second intervention period. A washout period of at least 14 days was maintained between each crizotinib dose.
281384|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
281385|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
281386|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
281387|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
281388|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
281389|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
281390|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
281391|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
281392|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
281393|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
281394|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
281732|NCT01296646|P1|Participant Flow|Placebo|Placebo taken once daily.
281398|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
281399|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
281400|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
281401|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
281402|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
281403|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
281404|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
281405|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
281406|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
281407|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
281408|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
281409|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
281410|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
281411|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
281412|NCT01297595|E2|Reported Event|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
281413|NCT01297595|E1|Reported Event|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
281414|NCT01297517|B4|Baseline|Total|Total of all reporting groups
281415|NCT01297517|B3|Baseline|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
281416|NCT01297517|B2|Baseline|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
281417|NCT01297517|B1|Baseline|Brinzolamide/Brimonidine|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
281418|NCT01297517|P3|Participant Flow|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
281419|NCT01297517|P2|Participant Flow|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
281420|NCT01297517|P1|Participant Flow|Brinzolamide/Brimonidine|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
281421|NCT01297517|O3|Outcome|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
281422|NCT01297517|O2|Outcome|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
281423|NCT01297517|O1|Outcome|Brinzolamide/Brimonidine|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
281424|NCT01297517|E3|Reported Event|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
281425|NCT01297517|E2|Reported Event|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
281426|NCT01297517|E1|Reported Event|Brinzolamide/Brimonidine|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
281427|NCT01297504|B1|Baseline|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
281428|NCT01297504|P1|Participant Flow|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
281429|NCT01297504|O1|Outcome|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
281430|NCT01297504|O1|Outcome|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
281431|NCT01297504|O1|Outcome|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
281432|NCT01297504|O2|Outcome|Multivariate|
281433|NCT01297504|O1|Outcome|Univariate|
281434|NCT01297504|O2|Outcome|LTRI Due to RSV|Hospitalizations due to lower respiratory tract infections (LRTI) caused by RSV
281435|NCT01297504|O1|Outcome|LTRI|Hospitalizations due to lower respiratory tract infections (LRTI).
281436|NCT01297504|O1|Outcome|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
281437|NCT01297504|O1|Outcome|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
281438|NCT01297504|E1|Reported Event|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
281440|NCT01297491|B2|Baseline|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
281441|NCT01297491|B1|Baseline|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
281442|NCT01297491|P2|Participant Flow|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
281443|NCT01297491|P1|Participant Flow|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
281444|NCT01297491|O2|Outcome|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
281445|NCT01297491|O1|Outcome|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
281446|NCT01297491|O2|Outcome|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
281447|NCT01297491|O1|Outcome|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
281448|NCT01297491|O2|Outcome|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
281449|NCT01297491|O1|Outcome|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
281450|NCT01297491|O2|Outcome|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
281451|NCT01297491|O1|Outcome|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
281452|NCT01297491|O2|Outcome|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
281453|NCT01297491|O1|Outcome|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
281454|NCT01297491|O2|Outcome|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
281455|NCT01297491|O1|Outcome|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
281456|NCT01297491|E2|Reported Event|Non-Squamous BKM120 100 mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
281457|NCT01297491|E1|Reported Event|Squamous BKM120 100 mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
281458|NCT01297465|B3|Baseline|Total|Total of all reporting groups
281459|NCT01297465|B2|Baseline|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
281460|NCT01297465|B1|Baseline|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
281461|NCT01297465|P2|Participant Flow|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
281462|NCT01297465|P1|Participant Flow|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
281463|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
281464|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
281465|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
281466|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
281467|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
281468|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
281469|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
281470|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
281471|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
281472|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
281473|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
281474|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
281475|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
281476|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
281477|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
281733|NCT01296646|O2|Outcome|Naltrexone|50 mg of naltrexone orally daily.
281478|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
281479|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
281480|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
281481|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
281482|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
281483|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
281484|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
281485|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
281486|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
281487|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
281488|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
281489|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
281513|NCT01297322|B2|Baseline|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
281514|NCT01297322|B1|Baseline|Manual Compression|Manual compression: Standard of Care
281515|NCT01297322|P2|Participant Flow|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
281516|NCT01297322|P1|Participant Flow|Manual Compression|Manual compression: Standard of Care
281490|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
281491|NCT01297465|E2|Reported Event|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
281492|NCT01297465|E1|Reported Event|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
281493|NCT01297348|B3|Baseline|Total|Total of all reporting groups
281494|NCT01297348|B2|Baseline|Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)|Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
281495|NCT01297348|B1|Baseline|Lybrel|Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
281496|NCT01297348|P2|Participant Flow|Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)|Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
281497|NCT01297348|P1|Participant Flow|Lybrel|Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
281498|NCT01297348|O3|Outcome|Other OCs: Levonorgestrel, Ethinyl Estradiol 20 Mcg (Levo-20)|A subset of EE-20 group including participants who were current or past users of Levo-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and differing concentrations of levonorgestrel (progestin), were observed.
281499|NCT01297348|O2|Outcome|Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)|Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
281500|NCT01297348|O1|Outcome|Lybrel|Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
281501|NCT01297348|O3|Outcome|Other OCs: Levonorgestrel, Ethinyl Estradiol 20 Mcg (Levo-20)|A subset of EE-20 group including participants who were current or past users of Levo-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and differing concentrations of levonorgestrel (progestin), were observed.
281502|NCT01297348|O2|Outcome|Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)|Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
281503|NCT01297348|O1|Outcome|Lybrel|Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
281504|NCT01297348|E2|Reported Event|Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)|Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
281505|NCT01297348|E1|Reported Event|Lybrel|Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
281506|NCT01297335|B1|Baseline|Intrathecal Clonidine|All subjects met all inclusion and exclusionary criteria, and we report study subjects' demographic information in following sections.
281507|NCT01297335|P1|Participant Flow|Intrathecal Clonidine|"Subject will receive one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg will be delivered. Supine and sitting blood pressures and heart rate will be measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.~clonidine: Intrathecal Clonidine"
281508|NCT01297335|O1|Outcome|Intrathecal Clonidine|Subjects were asked to rate both level of sedation and dryness of their mouths (two of the most common side effects of clonidine) at before clonidine injection (baseline) and at one hour after clonidine injection (Post injection) on VAS scale. VAS scale is an analogue scale that measures subject response from 0 to 10 cm, where larger value represents greater level of sedation and dryness in the mouth subject experienced.
281509|NCT01297335|O1|Outcome|Intrathecal Clonidine|"Subject will receive one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg will be delivered. Supine and sitting blood pressures and heart rate will be measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.~clonidine: Intrathecal Clonidine"
281510|NCT01297335|O1|Outcome|Intrathecal Clonidine|Subject received one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg were delivered. Supine and sitting blood pressures and heart rate were measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.
281511|NCT01297335|E1|Reported Event|Intrathecal Clonidine|"Subject will receive one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg will be delivered. Supine and sitting blood pressures and heart rate will be measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.~clonidine: Intrathecal Clonidine"
281517|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
281518|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
281519|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
281520|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
281521|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
281522|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
281523|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
281524|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
281525|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
281526|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
281527|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
281528|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
281529|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
281530|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
281531|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
281532|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
281533|NCT01297322|E2|Reported Event|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
281534|NCT01297322|E1|Reported Event|Manual Compression|Manual compression: Standard of Care
281535|NCT01297283|B1|Baseline|Overall Subjects|
281536|NCT01297283|P1|Participant Flow|Overall Subjects|Measurement of pacing thresholds are done first with the support of a leadless ECG provided by the implanted device
281537|NCT01297283|O1|Outcome|Overall Subjects|
281538|NCT01297283|O1|Outcome|Overall Subjects|
281539|NCT01297283|E1|Reported Event|Overall Subjects|
281540|NCT01297270|B4|Baseline|Total|Total of all reporting groups
281541|NCT01297270|B3|Baseline|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
281542|NCT01297270|B2|Baseline|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281543|NCT01297270|B1|Baseline|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281544|NCT01297270|P3|Participant Flow|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
281545|NCT01297270|P2|Participant Flow|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281546|NCT01297270|P1|Participant Flow|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir (BI 201335) 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281547|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
281548|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281549|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281550|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
281551|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281552|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281553|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
281554|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281734|NCT01296646|O1|Outcome|Placebo|Placebo taken once daily.
281555|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281556|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
281557|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281558|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281559|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
281560|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281561|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281562|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
281563|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281564|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281565|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
281566|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281567|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281568|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
281569|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281570|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281571|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
281572|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281573|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281574|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
281575|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281576|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281577|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
281578|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281655|NCT01296763|O2|Outcome|Dose Level 2|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100mg bid oral, Day 1-3, Day 8-10"
281579|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281580|NCT01297270|E3|Reported Event|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
281581|NCT01297270|E2|Reported Event|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281582|NCT01297270|E1|Reported Event|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
281583|NCT01297257|B1|Baseline|Group 1 Resolute Integrity™ Stent Primary Stent|A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.
281584|NCT01297257|P1|Participant Flow|Group 1 Resolute Integrity™ Stent Primary Stent|A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.
281585|NCT01297257|O1|Outcome|Group 1 Resolute Integrity™ Stent Primary Stent|A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.
281586|NCT01297257|O1|Outcome|Group 1 Resolute Integrity™ Stent Primary Stent|A total of 7,740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 10,733 Resolute Integrity™ Stents
281587|NCT01297257|E1|Reported Event|Group 1 Resolute Integrity™ Stent Primary Stent|A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.
281588|NCT01297062|B7|Baseline|Total|Total of all reporting groups
281589|NCT01297062|B6|Baseline|Exenatide-Placebo-Moxifloxacin Sequence|Exenatide in Period I; Placebo comparator in Period II; Moxifloxacin with placebo infusion in Period III
281590|NCT01297062|B5|Baseline|Placebo-Moxifloxacin-Exenatiden Sequence|Placebo comparator in Period I; Moxifloxacin with placebo infusion in Period II; Exenatide in Period III
281591|NCT01297062|B4|Baseline|Moxifloxacin-Exenatide-Placebo Sequence|Moxifloxacin with placebo infusion in Period I; Exenatide in Period II; Placebo comparator in Period III
281592|NCT01297062|B3|Baseline|Moxifloxacin-Placebo-Exenatide Sequence|Moxifloxacin with placebo infusion in Period I; Placebo comparator in Period II; Exenatide in Period III
281593|NCT01297062|B2|Baseline|Exenatide-Moxifloxacin-Placebo Sequence|Exenatide in Period I; Moxifloxacin with placebo infusion in Period II; Placebo comparator in Period III
281594|NCT01297062|B1|Baseline|Placebo-Exenatide-Moxifloxacin Sequence|Placebo comparator in Period I; Exenatide in Period II; Moxifloxacin with placebo infusion in Period III
281595|NCT01297062|P7|Participant Flow|Non-Randomized|Not Randomized
281596|NCT01297062|P6|Participant Flow|Exenatide-Placebo-Moxifloxacin Sequence|"Exenatide in Period I; Placebo comparator in Period II; Moxifloxacin with placebo infusion in Period III~Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)~Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2~Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
281597|NCT01297062|P5|Participant Flow|Placebo-Moxifloxacin-Exenatiden Sequence|"Placebo comparator in Period I; Moxifloxacin with placebo infusion in Period II; Exenatide in Period III~Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)~Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2~Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
281598|NCT01297062|P4|Participant Flow|Moxifloxacin-Exenatide-Placebo Sequence|"Moxifloxacin with placebo infusion in Period I; Exenatide in Period II; Placebo comparator in Period III~Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)~Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2~Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
281599|NCT01297062|P3|Participant Flow|Moxifloxacin-Placebo-Exenatide Sequence|"Moxifloxacin with placebo infusion in Period I; Placebo comparator in Period II; Exenatide in Period III~Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)~Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2~Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
281600|NCT01297062|P2|Participant Flow|Exenatide-Moxifloxacin-Placebo Sequence|"Exenatide in Period I; Moxifloxacin with placebo infusion in Period II; Placebo comparator in Period III~Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)~Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2~Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
281656|NCT01296763|O1|Outcome|Dose Level 1|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100 mg bid oral, Days 1 and 8"
281657|NCT01296763|E3|Reported Event|Dose Level 5|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Mitomycin 5 mg/m2 IV, Day 1~Olaparib 100 mg bid oral, Days 1 and 8"
281601|NCT01297062|P1|Participant Flow|Placebo-Exenatide-Moxifloxacin Sequence|"Placebo comparator in Period I; Exenatide in Period II; Moxifloxacin with placebo infusion in Period III;~Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)~Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2~Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
281602|NCT01297062|O1|Outcome|Exenatide|Exenatide
281603|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
281604|NCT01297062|O1|Outcome|Exenatide|Exenatide
281605|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
281606|NCT01297062|O1|Outcome|Exenatide|Exenatide
281607|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
281608|NCT01297062|O1|Outcome|Moxifloxacin|Moxifloxacin with placebo infusion
281609|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
281610|NCT01297062|O1|Outcome|Moxifloxacin|Moxifloxacin with placebo infusion
281611|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
281612|NCT01297062|O1|Outcome|Moxifloxacin|Moxifloxacin with placebo infusion
281613|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
281614|NCT01297062|O1|Outcome|Exenatide|Exenatide
281615|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
281616|NCT01297062|O1|Outcome|Exenatide|Exenatide
281617|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
281618|NCT01297062|O1|Outcome|Exenatide|Exenatide
281619|NCT01297062|E3|Reported Event|Moxifloxacin|Moxifloxacin with placebo infusion
281620|NCT01297062|E2|Reported Event|Placebo|Placebo Comparator
281621|NCT01297062|E1|Reported Event|Exenatide|Exenatide
281622|NCT01296841|B3|Baseline|Total|Total of all reporting groups
281623|NCT01296841|B2|Baseline|Telemedicine Encounter|Remote clinical appointment between patient and physician.
281624|NCT01296841|B1|Baseline|Standard Encounter|"Standard in-house clinical visit between patient and physician."
281625|NCT01296841|P2|Participant Flow|Telemedicine Encounter|Remote clinical appointment between patient and physician.
281626|NCT01296841|P1|Participant Flow|Standard Encounter|"Standard in-house clinical visit between patient and physician."
281627|NCT01296841|O2|Outcome|Telemedicine Encounter|Remote clinical appointment between patient and physician.
281628|NCT01296841|O1|Outcome|Standard Encounter|"Standard in-house clinical visit between patient and physician."
281629|NCT01296841|O2|Outcome|Telemedicine Encounter|Remote clinical appointment between patient and physician.
281630|NCT01296841|O1|Outcome|Standard Encounter|"Standard in-house clinical visit between patient and physician."
281631|NCT01296841|O2|Outcome|Standard|clinic experience (mean±SD)
281632|NCT01296841|O1|Outcome|Telemedicine|clinic experience (mean ± SD, 1 excellent, 5 poor)
281633|NCT01296841|E2|Reported Event|Telemedicine Encounter|Remote clinical appointment between patient and physician.
281634|NCT01296841|E1|Reported Event|Standard Encounter|"Standard in-house clinical visit between patient and physician."
281635|NCT01296815|B3|Baseline|Total|Total of all reporting groups
281636|NCT01296815|B2|Baseline|HAART+ Bevacizumab Injection|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
281637|NCT01296815|B1|Baseline|HAART|Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
281638|NCT01296815|P2|Participant Flow|HAART+ Bevacizumab Injection|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
281639|NCT01296815|P1|Participant Flow|HAART|Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
281640|NCT01296815|O2|Outcome|HAART+ Bevacizumab Injection|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
281641|NCT01296815|O1|Outcome|HAART|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
281642|NCT01296815|E2|Reported Event|HAART+ Bevacizumab Injection|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
281643|NCT01296815|E1|Reported Event|HAART|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
281644|NCT01296763|B4|Baseline|Total|Total of all reporting groups
281645|NCT01296763|B3|Baseline|Dose Level 5|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Mitomycin 5 mg/m2 IV, Day 1~Olaparib 100 mg bid oral, Days 1 and 8"
281646|NCT01296763|B2|Baseline|Dose Level 2|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100mg bid oral, Day 1-3, Day 8-10"
281647|NCT01296763|B1|Baseline|Dose Level 1|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100 mg bid oral, Days 1 and 8"
281648|NCT01296763|P3|Participant Flow|Dose Level 5|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Mitomycin 5 mg/m2 IV, Day 1~Olaparib 100 mg bid oral, Days 1 and 8"
281649|NCT01296763|P2|Participant Flow|Dose Level 2|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100mg bid oral, Day 1-3, Day 8-10"
281650|NCT01296763|P1|Participant Flow|Dose Level 1|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100 mg bid oral, Days 1 and 8"
281651|NCT01296763|O3|Outcome|Dose Level 5|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Mitomycin 5 mg/m2 IV, Day 1~Olaparib 100 mg bid oral, Days 1 and 8"
281652|NCT01296763|O2|Outcome|Dose Level 2|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100mg bid oral, Day 1-3, Day 8-10"
281653|NCT01296763|O1|Outcome|Dose Level 1|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100 mg bid oral, Days 1 and 8"
281654|NCT01296763|O3|Outcome|Dose Level 5|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Mitomycin 5 mg/m2 IV, Day 1~Olaparib 100 mg bid oral, Days 1 and 8"
281735|NCT01296646|O2|Outcome|Naltrexone|50 mg of naltrexone orally daily.
281658|NCT01296763|E2|Reported Event|Dose Level 2|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100mg bid oral, Day 1-3, Day 8-10"
281659|NCT01296763|E1|Reported Event|Dose Level 1|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100 mg bid oral, Days 1 and 8"
281660|NCT01296698|B3|Baseline|Total|Total of all reporting groups
281661|NCT01296698|B2|Baseline|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281662|NCT01296698|B1|Baseline|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281663|NCT01296698|P2|Participant Flow|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281664|NCT01296698|P1|Participant Flow|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281665|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281666|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281667|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281668|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281669|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281670|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281671|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281672|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281673|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281674|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281675|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281676|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281677|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281678|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281679|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281680|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281681|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281682|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281683|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281684|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281685|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281686|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281687|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281688|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281689|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281690|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281691|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281692|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281693|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281694|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281695|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281696|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281697|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281698|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281699|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281700|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281701|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281702|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281703|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281704|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281705|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281706|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281707|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281708|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281709|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281710|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281711|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281712|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281713|NCT01296698|E2|Reported Event|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
281714|NCT01296698|E1|Reported Event|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
281715|NCT01296672|B3|Baseline|Total|Total of all reporting groups
281716|NCT01296672|B2|Baseline|Placebo|"Placebo 5mg tablet every day by mouth for 3 months~Placebo: Placebo every day by mouth for 3 months"
281717|NCT01296672|B1|Baseline|Finasteride|"Finasteride 5mg tablets every day by mouth for 3 months~Finasteride: Finasteride 5mg every day by mouth for 3 months"
281718|NCT01296672|P2|Participant Flow|Placebo|Placebo every day by mouth for 3 months
281719|NCT01296672|P1|Participant Flow|Finasteride|Finasteride 5mg every day by mouth for 3 months
281720|NCT01296672|O2|Outcome|Placebo|Placebo every day by mouth for 3 months
281721|NCT01296672|O1|Outcome|Finasteride|Finasteride 5mg every day by mouth for 3 months
281722|NCT01296672|O2|Outcome|Placebo|Placebo every day by mouth for 3 months
281723|NCT01296672|O1|Outcome|Finasteride|Finasteride 5mg every day by mouth for 3 months
281724|NCT01296672|O2|Outcome|Placebo|PSA Ratio AUC
281725|NCT01296672|O1|Outcome|Finasteride|PSA Ratio AUC
281737|NCT01296646|E2|Reported Event|Naltrexone|50 mg of naltrexone orally daily.
281738|NCT01296646|E1|Reported Event|Placebo|Placebo taken once daily.
281739|NCT01296412|B3|Baseline|Total|Total of all reporting groups
281740|NCT01296412|B2|Baseline|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
281741|NCT01296412|B1|Baseline|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
281742|NCT01296412|P2|Participant Flow|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
281743|NCT01296412|P1|Participant Flow|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
281744|NCT01296412|O2|Outcome|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
281745|NCT01296412|O1|Outcome|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
281746|NCT01296412|O2|Outcome|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
281747|NCT01296412|O1|Outcome|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
281748|NCT01296412|O2|Outcome|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
281749|NCT01296412|O1|Outcome|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
281750|NCT01296412|O2|Outcome|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
281751|NCT01296412|O1|Outcome|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
281752|NCT01296412|E2|Reported Event|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
281753|NCT01296412|E1|Reported Event|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
281754|NCT01296360|B3|Baseline|Total|Total of all reporting groups
281755|NCT01296360|B2|Baseline|Non-Booster Group|No treatment in study IC51-325
281756|NCT01296360|B1|Baseline|Booster Group|IC51 booster vaccination ~12 months after primary immunization in study IC51-323
281757|NCT01296360|P2|Participant Flow|Non-Booster Group|No treatment in study IC51-325
281758|NCT01296360|P1|Participant Flow|Booster Group|IC51 booster vaccination ~12 months after primary immunization in study IC51-323
281759|NCT01296360|O2|Outcome|>3 Years - <18 Years|booster vaccination: IXIARO 0.5 ml i.m (milliliter, intramuscular)
281760|NCT01296360|O1|Outcome|>14 Months to <2 Years|booster vaccination: IXIARO 0.25 ml i.m. (milliliter, intramuscular)
281761|NCT01296360|E2|Reported Event|Non-Booster Group|No treatment in study IC51-325
281762|NCT01296360|E1|Reported Event|Booster Group|IC51 booster vaccination ~12 months after primary immunization in study IC51-323
281763|NCT01296347|B3|Baseline|Total|Total of all reporting groups
281764|NCT01296347|B2|Baseline|Ketamine|"Patients will receive intravenous ketamine, starting 10 minutes prior to surgery and will continue for 96 hours~Ketamine: Intravenous infusion of ketamine starting 10 minutes prior to surgery and running for 96 hours, which will be administered at a rate of 0.1mg/kg/hour. A loading dose of 0.1mg/kg will be administered prior to the start of the infusion"
281765|NCT01296347|B1|Baseline|Saline|Patients will receive a placebo infusion of 0.9% sodium chloride, which will start 10 minutes prior to the start of the operation and continue for 96 hours.
281766|NCT01296347|P2|Participant Flow|Ketamine|"Patients will receive intravenous ketamine, starting 10 minutes prior to surgery and will continue for 96 hours~Ketamine: Intravenous infusion of ketamine starting 10 minutes prior to surgery and running for 96 hours, which will be administered at a rate of 0.1mg/kg/hour. A loading dose of 0.1mg/kg will be administered prior to the start of the infusion"
281767|NCT01296347|P1|Participant Flow|Saline|Patients will receive a placebo infusion of 0.9% sodium chloride, which will start 10 minutes prior to the start of the operation and continue for 96 hours.
281768|NCT01296347|O2|Outcome|Ketamine|"Patients will receive intravenous ketamine, starting 10 minutes prior to surgery and will continue for 96 hours~Ketamine: Intravenous infusion of ketamine starting 10 minutes prior to surgery and running for 96 hours, which will be administered at a rate of 0.1mg/kg/hour. A loading dose of 0.1mg/kg will be administered prior to the start of the infusion"
325353|NCT01185080|P2|Participant Flow|Placebo|Placebo three times weekly
281769|NCT01296347|O1|Outcome|Saline|Patients will receive a placebo infusion of 0.9% sodium chloride, which will start 10 minutes prior to the start of the operation and continue for 96 hours.
281770|NCT01296347|E2|Reported Event|Ketamine|"Patients will receive intravenous ketamine, starting 10 minutes prior to surgery and will continue for 96 hours~Ketamine: Intravenous infusion of ketamine starting 10 minutes prior to surgery and running for 96 hours, which will be administered at a rate of 0.1mg/kg/hour. A loading dose of 0.1mg/kg will be administered prior to the start of the infusion"
281771|NCT01296347|E1|Reported Event|Saline|Patients will receive a placebo infusion of 0.9% sodium chloride, which will start 10 minutes prior to the start of the operation and continue for 96 hours.
281772|NCT01296152|B1|Baseline|Depo-medroxyprogesterone Acetate (DMPA)|"At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.~depo-medroxyprogesterone acetate: At study entry/ Day 0, participants will receive Depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.~Depo-medroxyprogesterone Acetate"
281773|NCT01296152|P1|Participant Flow|Depo-medroxyprogesterone Acetate (DMPA)|"At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.~depo-medroxyprogesterone acetate: At study entry/ Day 0, participants will receive Depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.~Depo-medroxyprogesterone Acetate"
281774|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
281775|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
281776|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
281777|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
281778|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
281779|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
281780|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
281781|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
281782|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
281783|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
281784|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
281785|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
281786|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
281787|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
281788|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
281789|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
281790|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
281791|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
281792|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
281793|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
281794|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
281795|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
281796|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
281797|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
281798|NCT01296152|E1|Reported Event|Arm A|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
281799|NCT01296035|B1|Baseline|Panitumuab and Gemcitabine|Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
281800|NCT01296035|P1|Participant Flow|Panitumuab and Gemcitabine|Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
281801|NCT01296035|O1|Outcome|Panitumuab and Gemcitabine|Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
281802|NCT01296035|O1|Outcome|Panitumuab and Gemcitabine|Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
281803|NCT01296035|E1|Reported Event|Panitumuab and Gemcitabine|Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
281804|NCT01295905|B3|Baseline|Total|Total of all reporting groups
281805|NCT01295905|B2|Baseline|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
281806|NCT01295905|B1|Baseline|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
281807|NCT01295905|P2|Participant Flow|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
281808|NCT01295905|P1|Participant Flow|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
281809|NCT01295905|O2|Outcome|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
281810|NCT01295905|O1|Outcome|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
281811|NCT01295905|O2|Outcome|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
281812|NCT01295905|O1|Outcome|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
281813|NCT01295905|O2|Outcome|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
281814|NCT01295905|O1|Outcome|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
281815|NCT01295905|O2|Outcome|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
281816|NCT01295905|O1|Outcome|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
281817|NCT01295905|E2|Reported Event|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
281818|NCT01295905|E1|Reported Event|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
281819|NCT01295879|B1|Baseline|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
281820|NCT01295879|P1|Participant Flow|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
281821|NCT01295879|O1|Outcome|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
281822|NCT01295879|O1|Outcome|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
281823|NCT01295879|O1|Outcome|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
281824|NCT01295879|E1|Reported Event|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
281825|NCT01295840|B1|Baseline|No Arms|All patient have a Quartet LV lead. No arms.
281826|NCT01295840|P1|Participant Flow|No Arms|All patient have a Quartet Left Ventricular (LV) lead. No arms.
281827|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
281828|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
281829|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
281830|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
281831|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
281832|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
281833|NCT01295840|O1|Outcome|Quartet LV Lead|All patient have a Quartet LV lead. No arms
281834|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
281835|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
281836|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
281837|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms.
281838|NCT01295840|E1|Reported Event|No Arms|All patient have a Quartet LV lead. No arms
281839|NCT01295814|B3|Baseline|Total|Total of all reporting groups
281840|NCT01295814|B2|Baseline|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
281841|NCT01295814|B1|Baseline|Inactive Drug|inactive drug : placebo
281842|NCT01295814|P2|Participant Flow|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
281843|NCT01295814|P1|Participant Flow|Inactive Drug|inactive drug : placebo
281844|NCT01295814|O2|Outcome|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
281845|NCT01295814|O1|Outcome|Inactive Drug|inactive drug : placebo
281846|NCT01295814|O2|Outcome|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
281847|NCT01295814|O1|Outcome|Inactive Drug|inactive drug : placebo
281848|NCT01295814|O2|Outcome|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
281849|NCT01295814|O1|Outcome|Inactive Drug|inactive drug : placebo
281850|NCT01295814|O2|Outcome|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
281851|NCT01295814|O1|Outcome|Inactive Drug|inactive drug : placebo
281852|NCT01295814|O2|Outcome|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
281853|NCT01295814|O1|Outcome|Inactive Drug|inactive drug : placebo
281854|NCT01295814|E2|Reported Event|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
281855|NCT01295814|E1|Reported Event|Inactive Drug|inactive drug : placebo
281856|NCT01295671|B4|Baseline|Total|Total of all reporting groups
281857|NCT01295671|B3|Baseline|Unsweetened Beverages|"Unsweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281858|NCT01295671|B2|Baseline|Artificially-Sweetened Beverages|"Artificially-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281859|NCT01295671|B1|Baseline|Sugar-Sweetened Beverages|"Sugar-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281860|NCT01295671|P3|Participant Flow|Unsweetened Beverages|"Provision of beverages: Unsweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281861|NCT01295671|P2|Participant Flow|Artificially-sweetened Beverages|"Provision of beverages: Artificially-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281862|NCT01295671|P1|Participant Flow|Sugar-Sweetened Beverages|"Provision of beverages: Sugar-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281863|NCT01295671|O3|Outcome|Unsweetened Beverages|"Provision of beverages: Unsweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281864|NCT01295671|O2|Outcome|Artificially-sweetened Beverages|"Provision of beverages: Artificially-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281865|NCT01295671|O1|Outcome|Sugar-Sweetened Beverages|"Provision of beverages: Sugar-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281866|NCT01295671|O3|Outcome|Unsweetened Beverages|"Provision of beverages: Unsweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281867|NCT01295671|O2|Outcome|Artificially-sweetened Beverages|"Provision of beverages: Artificially-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281868|NCT01295671|O1|Outcome|Sugar-Sweetened Beverages|"Provision of beverages: Sugar-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281869|NCT01295671|O3|Outcome|Unsweetened Beverages|"Provision of beverages: Unsweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281870|NCT01295671|O2|Outcome|Artificially-sweetened Beverages|"Provision of beverages: Artificially-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281871|NCT01295671|O1|Outcome|Sugar-Sweetened Beverages|"Provision of beverages: Sugar-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281872|NCT01295671|O3|Outcome|Unsweetened Beverages|"Provision of beverages: Unsweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281873|NCT01295671|O2|Outcome|Artificially-sweetened Beverages|"Provision of beverages: Artificially-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281874|NCT01295671|O1|Outcome|Sugar-Sweetened Beverages|"Provision of beverages: Sugar-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281875|NCT01295671|O3|Outcome|Unsweetened Beverages|"Provision of beverages: Unsweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281876|NCT01295671|O2|Outcome|Artificially-sweetened Beverages|"Provision of beverages: Artificially-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281877|NCT01295671|O1|Outcome|Sugar-Sweetened Beverages|"Provision of beverages: Sugar-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281878|NCT01295671|O3|Outcome|Unsweetened Beverages|"Provision of beverages: Unsweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281879|NCT01295671|O2|Outcome|Artificially-sweetened Beverages|"Provision of beverages: Artificially-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281880|NCT01295671|O1|Outcome|Sugar-Sweetened Beverages|"Provision of beverages: Sugar-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281881|NCT01295671|O3|Outcome|Unsweetened Beverages|"Provision of beverages: Unsweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281882|NCT01295671|O2|Outcome|Artificially-sweetened Beverages|"Provision of beverages: Artificially-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281883|NCT01295671|O1|Outcome|Sugar-Sweetened Beverages|"Provision of beverages: Sugar-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281884|NCT01295671|O3|Outcome|Unsweetened Beverages|"Provision of beverages: Unsweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281885|NCT01295671|O2|Outcome|Artificially-sweetened Beverages|"Provision of beverages: Artificially-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281886|NCT01295671|O1|Outcome|Sugar-Sweetened Beverages|"Provision of beverages: Sugar-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281887|NCT01295671|O3|Outcome|Unsweetened Beverages|"Provision of beverages: Unsweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281888|NCT01295671|O2|Outcome|Artificially-sweetened Beverages|"Provision of beverages: Artificially-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281889|NCT01295671|O1|Outcome|Sugar-Sweetened Beverages|"Provision of beverages: Sugar-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281890|NCT01295671|O3|Outcome|Unsweetened Beverages|"Provision of beverages: Unsweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281891|NCT01295671|O2|Outcome|Artificially-sweetened Beverages|"Provision of beverages: Artificially-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281892|NCT01295671|O1|Outcome|Sugar-Sweetened Beverages|"Provision of beverages: Sugar-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281893|NCT01295671|O3|Outcome|Unsweetened Beverages|"Provision of beverages: Unsweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281894|NCT01295671|O2|Outcome|Artificially-sweetened Beverages|"Provision of beverages: Artificially-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281895|NCT01295671|O1|Outcome|Sugar-Sweetened Beverages|"Provision of beverages: Sugar-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281896|NCT01295671|E3|Reported Event|Group 3|"Unsweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281897|NCT01295671|E2|Reported Event|Group 2|"Artificially-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281898|NCT01295671|E1|Reported Event|Group 1|"Sugar-sweetened beverages~Provision of beverages: Home delivery of specified beverage type"
281899|NCT01295320|B1|Baseline|GSK1437173A Group|Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). No treatment was given in this current study (NCT01295320).
281900|NCT01295320|P1|Participant Flow|GSK1437173A Group|Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). No treatment was given in this current study (NCT01295320).
281901|NCT01295320|O1|Outcome|GSK1437173A Group|Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). No treatment was given in this current study (NCT01295320).
281902|NCT01295320|O1|Outcome|GSK1437173A Group|Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). No treatment was given in this current study (NCT01295320).
281903|NCT01295320|O1|Outcome|GSK1437173A Group|Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). No treatment was given in this current study (NCT01295320).
281904|NCT01295320|O1|Outcome|GSK1437173A Group|Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). No treatment was given in this current study (NCT01295320).
281905|NCT01295320|O1|Outcome|GSK1437173A Group|Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). No treatment was given in this current study (NCT01295320).
281906|NCT01295320|O1|Outcome|GSK1437173A Group|Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). No treatment was given in this current study (NCT01295320).
281907|NCT01295320|O1|Outcome|GSK1437173A Group|Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). No treatment was given in this current study (NCT01295320).
281908|NCT01295320|O1|Outcome|GSK1437173A Group|Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). No treatment was given in this current study (NCT01295320).
281909|NCT01295320|O1|Outcome|GSK1437173A Group|Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). No treatment was given in this current study (NCT01295320).
281910|NCT01295320|O1|Outcome|GSK1437173A Group|Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). No treatment was given in this current study (NCT01295320).
281911|NCT01295320|O1|Outcome|GSK1437173A Group|Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). No treatment was given in this current study (NCT01295320).
281912|NCT01295320|O1|Outcome|GSK1437173A Group|Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). No treatment was given in this current study (NCT01295320).
281913|NCT01295320|E1|Reported Event|GSK1437173A Group|Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). No treatment was given in this current study (NCT01295320).
281914|NCT01295281|B3|Baseline|Total|Total of all reporting groups
281915|NCT01295281|B2|Baseline|LoFric PVC - POBE 2.0|"First period (7 days) use of LoFric PVC followed by second period (7 days) use of LoFric POBE 2.0.~LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.~LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively."
281916|NCT01295281|B1|Baseline|LoFric POBE 2.0 - PVC|"First period (7 days) use of LoFric POBE 2.0 followed by second period (7 days) use of LoFric PVC~LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.~LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively."
281917|NCT01295281|P2|Participant Flow|LoFric PVC - POBE 2.0|"First period (7 days) use of LoFric PVC followed by second period (7 days) use of LoFric POBE 2.0.~LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.~LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively."
281918|NCT01295281|P1|Participant Flow|LoFric POBE 2.0 - PVC|"First period (7 days) use of LoFric POBE 2.0 followed by second period (7 days) use of LoFric PVC~LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.~LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively."
281919|NCT01295281|O2|Outcome|LoFric PVC|Single use LoFric PVC catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting.
281920|NCT01295281|O1|Outcome|LoFric POBE 2.0|Single use LoFric POBE 2.0 catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting.
281921|NCT01295281|E2|Reported Event|LoFric PVC|Single use LoFric PVC catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting.
281922|NCT01295281|E1|Reported Event|LoFric POBE 2.0|Single use LoFric POBE 2.0 catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting.
281923|NCT01295216|B3|Baseline|Total|Total of all reporting groups
281924|NCT01295216|B2|Baseline|Control|Individuals who receive the usual primary health care
281925|NCT01295216|B1|Baseline|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months~Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
281926|NCT01295216|P2|Participant Flow|Control|Individuals who receive the usual primary health care
281989|NCT01294800|O2|Outcome|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
281927|NCT01295216|P1|Participant Flow|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months~Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
281928|NCT01295216|O2|Outcome|Control|Individuals who receive the usual primary health care
281929|NCT01295216|O1|Outcome|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months~Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
281930|NCT01295216|O2|Outcome|Control|Individuals who receive the usual primary health care
281931|NCT01295216|O1|Outcome|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months~Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
281932|NCT01295216|O2|Outcome|Control|Individuals who receive the usual primary health care
281933|NCT01295216|O1|Outcome|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months~Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
281934|NCT01295216|O2|Outcome|Control|Individuals who receive the usual primary health care
281935|NCT01295216|O1|Outcome|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months~Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
281936|NCT01295216|O2|Outcome|Control|Individuals who receive the usual primary health care
281937|NCT01295216|O1|Outcome|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months~Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
281938|NCT01295216|O2|Outcome|Control|Individuals who receive the usual primary health care
281939|NCT01295216|O1|Outcome|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months~Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
281940|NCT01295216|E2|Reported Event|Control|Individuals who receive the usual primary health care
281941|NCT01295216|E1|Reported Event|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months~Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
281942|NCT01295112|B3|Baseline|Total|Total of all reporting groups
281943|NCT01295112|B2|Baseline|Group 2|"Active bevacizumab (Avastin®) and Active Ozurdex®~Active bevacizumab and Active dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose"
281944|NCT01295112|B1|Baseline|Group 1|"Active bevacizumab (Avastin®) and Sham Ozurdex®~Active bevacizumab and Sham dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe"
281945|NCT01295112|P2|Participant Flow|Group 2|"Active bevacizumab (Avastin®) and Active Ozurdex®~Active bevacizumab and Active dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose"
281946|NCT01295112|P1|Participant Flow|Group 1|"Active bevacizumab (Avastin®) and Sham Ozurdex®~Active bevacizumab and Sham dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe"
281947|NCT01295112|O2|Outcome|Group 2|"Active bevacizumab (Avastin®) and Active Ozurdex®~Active bevacizumab and Active dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose"
281948|NCT01295112|O1|Outcome|Group 1|"Active bevacizumab (Avastin®) and Sham Ozurdex®~Active bevacizumab and Sham dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe"
281949|NCT01295112|O2|Outcome|Group 2|"Active bevacizumab (Avastin®) and Active Ozurdex®~Active bevacizumab and Active dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose"
281950|NCT01295112|O1|Outcome|Group 1|"Active bevacizumab (Avastin®) and Sham Ozurdex®~Active bevacizumab and Sham dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe"
281951|NCT01295112|E2|Reported Event|Group 2|"Active bevacizumab (Avastin®) and Active Ozurdex®~Active bevacizumab and Active dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose"
281952|NCT01295112|E1|Reported Event|Group 1|"Active bevacizumab (Avastin®) and Sham Ozurdex®~Active bevacizumab and Sham dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe"
281953|NCT01295034|B3|Baseline|Total|Total of all reporting groups
281954|NCT01295034|B2|Baseline|Tiered/Titrated Vitamin B Dosing|tiered/titrated vitamin D dosing: Subjects in Protocol B received 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
281955|NCT01295034|B1|Baseline|Conventional Vitamin B Dosing|Subjects in Protocol A (the conventional/active placebo arm) will receive 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
281990|NCT01294800|O1|Outcome|Preladenant 2 mg|Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
281956|NCT01295034|P2|Participant Flow|Tiered/Titrated Vitamin D Dosing|tiered/titrated vitamin D dosing: Subjects in Protocol B received 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
281957|NCT01295034|P1|Participant Flow|Conventional Vitamin D Treatment|conventional vitamin D treatment: Subjects in Protocol A (the conventional/active placebo arm) received 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
281958|NCT01295034|O2|Outcome|Tiered/Titrated Vitamin D Dosing|tiered/titrated vitamin D dosing: Subjects in Protocol B received 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
281959|NCT01295034|O1|Outcome|Conventional Vitamin B Dosing|Subjects in Protocol A (the conventional/active placebo arm) received 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
281960|NCT01295034|O2|Outcome|Tiered/Titrated Vitamin D Dosing|tiered/titrated vitamin D dosing: Subjects in Protocol B received 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
281961|NCT01295034|O1|Outcome|Conventional Vitamin D Treatment|conventional vitamin D treatment: Subjects in Protocol A (the conventional/active placebo arm) received 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
281962|NCT01295034|E2|Reported Event|Tiered/Titrated Vitamin B Dosing|Subjects in Protocol B received 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
281963|NCT01295034|E1|Reported Event|Conventional Vitamin B Dosing|Subjects in Protocol A (the conventional/active placebo arm) received 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
281964|NCT01294917|B1|Baseline|All Participants|All subjects received each of 3 study solutions for one month each for the daily care of their soft contact lenses. Subjects were randomized to six possible sequences of use of each study solution: AMO Investigational MPS, Clear Care and OptiFree ReplenisH MPS.
281965|NCT01294917|P1|Participant Flow|All Participants|All subjects received each of 3 study solutions for one month each for the daily care of their soft contact lenses. Subjects were randomized to six possible sequences of use of each study solution: AMO Investigational MPS, Clear Care and OptiFree ReplenisH MPS.
281966|NCT01294917|O3|Outcome|OptiFree RepleniSH MPS|All subjects received the OptiFree RepleniSH MPS for one month for the care of their soft contact lenses.
281967|NCT01294917|O2|Outcome|Clear Care|All subjects received the Clear Care for one month for the care of their soft contact lenses.
281968|NCT01294917|O1|Outcome|AMO Investigational MPS|All subjects received the AMO Investigational MPS for one month for the care of their soft contact lenses.
281969|NCT01294917|E1|Reported Event|All Participants|All subjects received each of 3 study solutions for one month each for the daily care of their soft contact lenses. Subjects were randomized to six possible sequences of use of each study solution: AMO Investigational MPS, Clear Care and OptiFree ReplenisH MPS.
281970|NCT01294800|B5|Baseline|Total|Total of all reporting groups
281971|NCT01294800|B4|Baseline|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
281972|NCT01294800|B3|Baseline|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
281973|NCT01294800|B2|Baseline|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
281974|NCT01294800|B1|Baseline|Preladenant 2 mg|Participants received preladenant 2 mg taken orally twice daily (BID), one tablet in the morning and one tablet in the evening, for 12 weeks.
281975|NCT01294800|P4|Participant Flow|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
281976|NCT01294800|P3|Participant Flow|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
281977|NCT01294800|P2|Participant Flow|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
281978|NCT01294800|P1|Participant Flow|Preladenant 2 mg|Participants received preladenant 2 mg taken orally twice daily (BID), one tablet in the morning and one tablet in the evening, for 12 weeks.
281979|NCT01294800|O4|Outcome|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
281980|NCT01294800|O3|Outcome|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
281981|NCT01294800|O2|Outcome|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
281982|NCT01294800|O1|Outcome|Preladenant 2 mg|Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
281983|NCT01294800|O4|Outcome|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
281984|NCT01294800|O3|Outcome|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
281985|NCT01294800|O2|Outcome|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
281986|NCT01294800|O1|Outcome|Preladenant 2 mg|Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
281987|NCT01294800|O4|Outcome|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
281988|NCT01294800|O3|Outcome|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
282036|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
281991|NCT01294800|O4|Outcome|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
281992|NCT01294800|O3|Outcome|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
281993|NCT01294800|O2|Outcome|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
281994|NCT01294800|O1|Outcome|Preladenant 2 mg|Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
281995|NCT01294800|O4|Outcome|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
281996|NCT01294800|O3|Outcome|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
281997|NCT01294800|O2|Outcome|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
281998|NCT01294800|O1|Outcome|Preladenant 2 mg|Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
281999|NCT01294800|E4|Reported Event|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
282000|NCT01294800|E3|Reported Event|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
282001|NCT01294800|E2|Reported Event|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
282002|NCT01294800|E1|Reported Event|Preladenant 2 mg|Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
282003|NCT01294787|B1|Baseline|All Participants|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods. One participant was randomized but did not receive study drug.
282004|NCT01294787|P6|Participant Flow|Tiotropium / Placebo / QVA149|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
282005|NCT01294787|P5|Participant Flow|Tiotropium / QAV149 / Placebo|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
282006|NCT01294787|P4|Participant Flow|Placebo / Tiotropium / QVA149|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
282007|NCT01294787|P3|Participant Flow|Placebo / QVA149 / Tiotropium|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
282008|NCT01294787|P2|Participant Flow|QVA149 / Tiotropium / Placebo|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
282009|NCT01294787|P1|Participant Flow|QVA149 / Placebo / Tiotropium|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
282010|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
282011|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
282012|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
282013|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
282014|NCT01294787|O1|Outcome|Indacaterol and Glycopyrronium Bromide (QVA149)|QVA149 delivered once daily via single-dose dry powder inhaler.
282015|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler.
282016|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
282017|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
282018|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler.
282019|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
282020|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
282021|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler.
282022|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
282023|NCT01294787|O1|Outcome|Indacaterol and Glycopyrronium Bromide (QVA149)|QVA149 delivered once daily via single-dose dry powder inhaler.
282024|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
282025|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
282026|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
282027|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
282028|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
282029|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
282030|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
282031|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
282032|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
282033|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
282034|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
282035|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
282037|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
282038|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
282039|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
282040|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
282041|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
282042|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler.
282043|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
282044|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
282045|NCT01294787|O2|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
282046|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
282047|NCT01294787|E3|Reported Event|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler.
282048|NCT01294787|E2|Reported Event|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
282049|NCT01294787|E1|Reported Event|Indacaterol and Glycopyrronium Bromide (QVA149)|QVA149 delivered once daily via single-dose dry powder inhaler.
282050|NCT01294748|B3|Baseline|Total|Total of all reporting groups
282051|NCT01294748|B2|Baseline|Endeavor DES|Active Comparator: Endeavor DES
282052|NCT01294748|B1|Baseline|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
282053|NCT01294748|P2|Participant Flow|Endeavor DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
282054|NCT01294748|P1|Participant Flow|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
282055|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
282056|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
282057|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
282058|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
282059|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
282060|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
282061|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
282062|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
282063|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
282064|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
282065|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
282066|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
282067|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
282068|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
282069|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
282070|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
282071|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
282072|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
282073|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
282074|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
282075|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
282076|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
282077|NCT01294748|E2|Reported Event|Endeavor DES|Active Comparator: Endeavor DES
282078|NCT01294748|E1|Reported Event|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
282079|NCT01294709|B1|Baseline|All Enrolled Participants|All enrolled participants who recieved at least one dose of either telcagepant or placebo.
282080|NCT01294709|P2|Participant Flow|Placebo Then Telcagepant|Participants receive single oral dose of two capsules or tablets of placebo for telcagepant (or three capsules of placebo for telcagepant) in Period 1 and a single oral dose of 600 mg (two 300 mg capsules or two bioequivalent 280 mg tablets) or 900 mg telcagepant (three 300 mg capsules) in Period 2 of the crossover. Each treatment period is separated by a washout of 96-240 hours.
282081|NCT01294709|P1|Participant Flow|Telcagepant Then Placebo|Participants receive single oral dose of 600 mg (two 300 mg capsules or two bioequivalent 280 mg tablets) or 900 mg telcagepant (three 300 mg capsules) in Period 1 and single oral dose of two capsules or tablets of placebo for telcagepant (or three capsules of placebo for telcagepant) in Period 2 of the crossover. Each treatment period is separated by a washout of 96-240 hours.
282287|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
282082|NCT01294709|O2|Outcome|Placebo|Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
282083|NCT01294709|O1|Outcome|Telcagepant|Participants who received a single oral dose of 600 mg (or bioequivalent 560 mg tablets) or 900 mg telcagepant in Period 1 or 2 of crossover
282084|NCT01294709|O2|Outcome|Placebo|Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
282085|NCT01294709|O1|Outcome|Telcagepant|Participants who received a single oral dose of 600 mg (or bioequivalent 560 mg tablets) or 900 mg telcagepant in Period 1 or 2 of crossover
282086|NCT01294709|O2|Outcome|Placebo|Participants who received single oral dose of placebo in Period 1 or 2 of crossover
282087|NCT01294709|O1|Outcome|Telcagepant|Participants who received a single oral dose of 600 mg (or bioequivalent 560 mg tablets) or 900 mg telcagepant in Period 1 or 2 of crossover
282088|NCT01294709|O3|Outcome|Placebo|Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
282089|NCT01294709|O2|Outcome|Telcagepant (900 mg)|Participants who received a single oral dose of 900 mg telcagepant in Period 1 or 2 of crossover
282090|NCT01294709|O1|Outcome|Telcagepant (600 mg)|Participants who received a single oral dose of 600 mg telcagepant capsules (or 560 mg of bioequivalent tablets) in Period 1 or 2 of crossover
282091|NCT01294709|O3|Outcome|Placebo|Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
282092|NCT01294709|O2|Outcome|Telcagepant (900 mg)|Participants who received a single oral dose of 900 mg telcagepant in Period 1 or 2 of crossover
282093|NCT01294709|O1|Outcome|Telcagepant (600 mg)|Participants who received a single oral dose of 600 mg telcagepant capsules (or 560 mg of bioequivalent tablets) in Period 1 or 2 of crossover
282094|NCT01294709|E3|Reported Event|Placebo|Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
282095|NCT01294709|E2|Reported Event|Telcagepant (900 mg)|Participants who received a single oral dose of 900 mg telcagepant in Period 1 or 2 of crossover
282096|NCT01294709|E1|Reported Event|Telcagepant (600 mg)|Participants who received a single oral dose of 600 mg telcagepant capsules (or 560 mg of bioequivalent tablets) in Period 1 or 2 of crossover
282097|NCT01294696|B3|Baseline|Total|Total of all reporting groups
282098|NCT01294696|B2|Baseline|Participants With Inadequate Pain Relief|Inadequate pain relief was defined as an average pain score of >4 on the BPI. Baseline characteristics are only reported for participants with data available at baseline.
282099|NCT01294696|B1|Baseline|Participants With Adequate Pain Relief|Adequate pain relief was defined as an average pain score of <=4 on the Brief Pain Inventory (BPI). Baseline characteristics are only reported for participants with data available at baseline.
282100|NCT01294696|P1|Participant Flow|All Enrolled Participants|The population consisted of all enrolled participants with adequate and inadequate pain relief.
282101|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
282102|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
282103|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
282104|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
282105|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
282106|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
282107|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
282108|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
282109|NCT01294696|E2|Reported Event|Participants With Inadequate Pain Relief|Inadequate pain relief was defined as an average pain score of >4 on the BPI. Baseline characteristics are only reported for participants with data available at baseline.
282110|NCT01294696|E1|Reported Event|Participants With Adequate Pain Relief|Adequate pain relief was fedined as an average pain score of <=4 on the Brief Pain Inventory (BPI).
282111|NCT01294683|B3|Baseline|Total|Total of all reporting groups
282112|NCT01294683|B2|Baseline|Sequence 2: MK-0524A 2g + Simvastatin 40 mg→ MK-0524B 2g/40g|After a 2-week placebo run-in, participants received ERN/LRPT 1 g (MK-0524A) co-administered with SIM 20 mg once daily for 4 weeks then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks. Participants then received ERN/LRPT/SIM 2 g/40 mg combination tablets (MK-0524B) once daily for 8 weeks.
282113|NCT01294683|B1|Baseline|Sequence 1: MK-0524B 2g/40g→MK-0524A 2g + Simvastatin 40 mg|After a 2-week placebo run-in, participants received extended release niacin/laropiprant (ERN/LRPT) 1 g/20 mg combination tablet (MK-0524B) once daily for 4 weeks, then ERN/LRPT/Simvastatin (SIM) 2 g/40 mg combination tablet once daily for 8 weeks. Participants then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks.
282114|NCT01294683|P2|Participant Flow|Sequence 2: MK-0524A 2g + Simvastatin 40 mg→ MK-0524B 2g/40g|After a 2-week placebo run-in, participants received ERN/LRPT 1 g (MK-0524A) co-administered with SIM 20 mg once daily for 4 weeks then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks. Participants then received ERN/LRPT/SIM 2 g/40 mg combination tablets (MK-0524B) once daily for 8 weeks.
282115|NCT01294683|P1|Participant Flow|Sequence 1: MK-0524B 2g/40g→MK-0524A 2g + Simvastatin 40 mg|After a 2-week placebo run-in, participants received extended release niacin/laropiprant (ERN/LRPT) 1 g/20 mg combination tablet (MK-0524B) once daily for 4 weeks, then ERN/LRPT/Simvastatin (SIM) 2 g/40 mg combination tablet once daily for 8 weeks. Participants then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks.
282116|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
282117|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
282865|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
282118|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
282119|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
282120|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
282121|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
282122|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
282123|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
282124|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
282125|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
282126|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
282127|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
282128|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
282129|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
282130|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
282131|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
282132|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
282133|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
282134|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
282135|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
282136|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
282137|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
282138|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
282139|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
282140|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
282141|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
282142|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
282143|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
282144|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
282145|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
282146|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
282147|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
282148|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
282149|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
282150|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
282151|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
282152|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
282153|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
282154|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
282155|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
282156|NCT01294683|O2|Outcome|MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
282157|NCT01294683|O1|Outcome|MK-0524B 2g/40mg|Participants who received MK-0524B 2g/40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
282158|NCT01294683|O2|Outcome|MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
282159|NCT01294683|O1|Outcome|MK-0524B 2g/40mg|Participants who received MK-0524B 2g/40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
282160|NCT01294683|E4|Reported Event|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
282161|NCT01294683|E3|Reported Event|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III
282867|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
282162|NCT01294683|E2|Reported Event|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II
282163|NCT01294683|E1|Reported Event|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
282164|NCT01294644|B4|Baseline|Total|Total of all reporting groups
282165|NCT01294644|B3|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
282166|NCT01294644|B2|Baseline|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
282167|NCT01294644|B1|Baseline|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
282168|NCT01294644|P3|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
282169|NCT01294644|P2|Participant Flow|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
282170|NCT01294644|P1|Participant Flow|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
282171|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
282172|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
282173|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
282174|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
282175|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
282176|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
282177|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
282178|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
282179|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
282180|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
282181|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
282182|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
282183|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
282184|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
282185|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
282186|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
282187|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
282188|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
282189|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
282190|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
282191|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
282288|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
282192|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
282193|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
282194|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
282195|NCT01294644|E3|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
282196|NCT01294644|E2|Reported Event|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
282197|NCT01294644|E1|Reported Event|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
282198|NCT01294592|B3|Baseline|Total|Total of all reporting groups
282199|NCT01294592|B2|Baseline|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
282200|NCT01294592|B1|Baseline|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
282201|NCT01294592|P2|Participant Flow|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
282202|NCT01294592|P1|Participant Flow|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
282203|NCT01294592|O3|Outcome|Watchful Waiting Escalated=Yes|All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
282204|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
282205|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
282206|NCT01294592|O2|Outcome|Watchful Waiting Escalated=Yes|All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
282207|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
282208|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
282209|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
282210|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
282211|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
282212|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
282213|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
282289|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
282290|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
282214|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
282215|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
282216|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
282217|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
282218|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
282219|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
282220|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
282221|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
282222|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
282223|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
282224|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
282225|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
282226|NCT01294592|E3|Reported Event|Watchful Waiting Escalated=Yes|All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
282227|NCT01294592|E2|Reported Event|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
282228|NCT01294592|E1|Reported Event|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
282229|NCT01294553|B1|Baseline|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to appropriate dose of Avandamet tablet (fixed dose combination of rosiglitazone and metformin, 1/500 milligrams [mg], 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg) per physician's decision based on participant's condition
282230|NCT01294553|P1|Participant Flow|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to the appropriate dose of Avandamet tablet based on their current regimen (fixed dose combination of rosiglitazone and metformin, 1/500 milligrams [mg], 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg). Participants were not to have exceeded the maximum recommended daily dose of 8/2000. All participants were to have started the rosiglitazone component of Avandamet at the lowest recommended dose, and all dose increases should have been accompanied by careful monitoring for adverse events related to fluid retention.
282231|NCT01294553|O1|Outcome|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to appropriate dose of Avandamet tablet (fixed dose combination of rosiglitazone and metformin, 1/500 mg, 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg) per physician's decision based on participant's condition
282232|NCT01294553|O1|Outcome|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to appropriate dose of Avandamet tablet (fixed dose combination of rosiglitazone and metformin, 1/500 mg, 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg) per physician's decision based on participant's condition
282291|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
282292|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
282233|NCT01294553|O1|Outcome|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to appropriate dose of Avandamet tablet (fixed dose combination of rosiglitazone and metformin, 1/500 milligrams [mg], 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg) per physician's decision based on participant's condition
282234|NCT01294553|E1|Reported Event|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to appropriate dose of Avandamet tablet (fixed dose combination of rosiglitazone and metformin, 1/500 milligrams [mg], 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg) per physician's decision based on participant's condition
282235|NCT01294514|B1|Baseline|Healthy Volunteers|Healthy volunteers were studied
282236|NCT01294514|P1|Participant Flow|Respiration Rate in Healthy Volunteers|"Healthy volunteer participants were monitored for 30 minute period to collect respiratory rate information from non-invasive sensors.~Covidien Respiration Rate, Transthoracic Impedance and Overscored Endtidal Carbon Dioxide."
282237|NCT01294514|O1|Outcome|Healthy Volunteers|Covidien Respiration Rate, Transthoracic Impedance and Overscored Endtidal Carbon Dioxide.
282238|NCT01294514|O1|Outcome|Healthy Volunteers|Covidien Respiration Rate, Transthoracic Impedance and Overscored Endtidal Carbon Dioxide derived respiration rates were recorded on all the volunteers simultaneously.
282239|NCT01294514|O3|Outcome|Respiration Rate From Transthoracic Impedance|Respiration Rate determined by Transthoracic Impedance
282240|NCT01294514|O2|Outcome|Respiration Rate From Endtidal Carbon Dioxide|Respiration Rate determined by manual overscoring of capnography waveforms.
282241|NCT01294514|O1|Outcome|Respiration Rate From Covidien Respiration Rate Software|Respiration Rate determined by novel plethysmographic analysis
282242|NCT01294514|E1|Reported Event|Healthy Volunteers|A selection of subjects from the general population from ages 18 - 50.
282243|NCT01294462|B3|Baseline|Total|Total of all reporting groups
282244|NCT01294462|B2|Baseline|Clopidogrel|Clopidogrel 75mg od
282245|NCT01294462|B1|Baseline|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90 mg bid
282246|NCT01294462|P2|Participant Flow|Clopidogrel|Clopidogrel 75mg od
282247|NCT01294462|P1|Participant Flow|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90 mg bid
282248|NCT01294462|O2|Outcome|Clopidogrel|Clopidogrel 75mg od
282249|NCT01294462|O1|Outcome|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90mg bid
282250|NCT01294462|O2|Outcome|Clopidogrel|Clopidogrel 75mg od
282251|NCT01294462|O1|Outcome|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90mg bid
282252|NCT01294462|O2|Outcome|Clopidogrel|Clopidogrel 75mg od
282253|NCT01294462|O1|Outcome|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90mg bid
282254|NCT01294462|O2|Outcome|Clopidogrel|Clopidogrel 75mg od
282255|NCT01294462|O1|Outcome|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90mg bid
282256|NCT01294462|E2|Reported Event|Clopidogrel|Clopidogrel 75mg od
282257|NCT01294462|E1|Reported Event|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90mg bid
282258|NCT01294449|B3|Baseline|Total|Total of all reporting groups
282259|NCT01294449|B2|Baseline|MADIT-CRT CRT-D|MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
282260|NCT01294449|B1|Baseline|MADIT-CRT ICD|MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
282261|NCT01294449|P2|Participant Flow|MADIT-CRT CRT-D|MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
282262|NCT01294449|P1|Participant Flow|MADIT-CRT ICD|MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
282263|NCT01294449|O2|Outcome|MADIT-CRT CRT-D|MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
282264|NCT01294449|O1|Outcome|MADIT-CRT ICD|MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
282265|NCT01294449|E2|Reported Event|MADIT-CRT CRT-D|MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
282266|NCT01294449|E1|Reported Event|MADIT-CRT ICD|MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
282267|NCT01294436|B3|Baseline|Total|Total of all reporting groups
282268|NCT01294436|B2|Baseline|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
282269|NCT01294436|B1|Baseline|Monotherapy|Dapagliflozin 5/10 mg only
282270|NCT01294436|P2|Participant Flow|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
282271|NCT01294436|P1|Participant Flow|Monotherapy|Dapagliflozin 5/10 mg only
282272|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
282273|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
282274|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
282275|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
282276|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
282277|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
282278|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
282279|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
282280|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
282281|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
282282|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
282283|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
282284|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
282285|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
282286|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
282294|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
282295|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
282296|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
282297|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
282298|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
282299|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
282300|NCT01294436|E2|Reported Event|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
282301|NCT01294436|E1|Reported Event|Monotherapy|Dapagliflozin 5/10 mg only
282302|NCT01294423|B4|Baseline|Total|Total of all reporting groups
282303|NCT01294423|B3|Baseline|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
282304|NCT01294423|B2|Baseline|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
282305|NCT01294423|B1|Baseline|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
282306|NCT01294423|P3|Participant Flow|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
282307|NCT01294423|P2|Participant Flow|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
282308|NCT01294423|P1|Participant Flow|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
282309|NCT01294423|O3|Outcome|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
282310|NCT01294423|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
282311|NCT01294423|O1|Outcome|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
282312|NCT01294423|O3|Outcome|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
282313|NCT01294423|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
282314|NCT01294423|O1|Outcome|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
282315|NCT01294423|O3|Outcome|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
282316|NCT01294423|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
282317|NCT01294423|O1|Outcome|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
282318|NCT01294423|E3|Reported Event|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
282319|NCT01294423|E2|Reported Event|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
282320|NCT01294423|E1|Reported Event|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
282321|NCT01294397|B1|Baseline|Etanercept + Denosumab|Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.
282322|NCT01294397|P1|Participant Flow|Etanercept + Denosumab|Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.
282323|NCT01294397|O1|Outcome|Etanercept + Denosumab|Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.
282324|NCT01294397|O1|Outcome|Etanercept + Denosumab|Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.
282325|NCT01294397|O1|Outcome|Etanercept + Denosumab|Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.
282326|NCT01294397|O1|Outcome|Etanercept + Denosumab|Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.
282327|NCT01294397|O1|Outcome|Etanercept + Denosumab|Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.
282328|NCT01294397|E3|Reported Event|All Subjects On-study|"Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.~Adverse events are reported from day -28 up to day 176."
282329|NCT01294397|E2|Reported Event|Etanercept 50 mg + Denosumab 60 mg Day 8 - EOS|"Participants received etanercept 50 mg subcutaneously once weekly. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.~Adverse events are reported from day 8 to end of study (day 176)."
282330|NCT01294397|E1|Reported Event|Etanercept 50 mg Day - 28 - Day 7|Participants received etanercept 50 mg subcutaneously once weekly. Adverse events are reported from day -28 until day 7.
282331|NCT01294384|B4|Baseline|Total|Total of all reporting groups
282332|NCT01294384|B3|Baseline|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
282333|NCT01294384|B2|Baseline|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
282334|NCT01294384|B1|Baseline|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
282335|NCT01294384|P3|Participant Flow|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
282336|NCT01294384|P2|Participant Flow|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
282337|NCT01294384|P1|Participant Flow|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
325635|NCT01183858|B3|Baseline|Total|Total of all reporting groups
282338|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
282339|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
282340|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
282341|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
282342|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
282343|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
282344|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
282345|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
282346|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
282347|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
282348|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
282349|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
282350|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
282351|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
282352|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
282353|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
282354|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
282355|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
282356|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
282357|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
282358|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
282359|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
282360|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
282361|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
282362|NCT01294384|E3|Reported Event|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
282363|NCT01294384|E2|Reported Event|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
282364|NCT01294384|E1|Reported Event|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
282365|NCT01294371|B1|Baseline|Leuprorelin|"Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period.~Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products."
282366|NCT01294371|P1|Participant Flow|Leuprorelin|"Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period.~Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products."
282367|NCT01294371|O3|Outcome|No Add-Back Therapy|Participants with genital endometriosis received leuprorelin in accordance with the respective Marketing Authorization/ Manufacturer's directions, and no add-back therapy.
282368|NCT01294371|O2|Outcome|Plus Add-Back Therapy|Participants with genital endometriosis received leuprorelin in accordance with the respective Marketing Authorization/ Manufacturer's directions, and add-back therapy following local guidelines or therapeutic recommendations.
282421|NCT01294241|O2|Outcome|Non-adhesive Wound Dressing Only|The other half of an EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size was treated with non-adhesive wound Dressing only as control.
326775|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
282369|NCT01294371|O1|Outcome|Overall|"Participants with genital endometriosis received leuprorelin in accordance with the respective Marketing Authorization/ Manufacturer's directions for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was carried out on the 3rd day of a menstrual period.~Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was impossible — phytoestrogens with calcium products."
282370|NCT01294371|O1|Outcome|Leuprorelin|"Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period.~Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products."
282371|NCT01294371|O1|Outcome|Leuprorelin|"Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period.~Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products."
282372|NCT01294371|E1|Reported Event|Leuprorelin|"Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period.~Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products."
282373|NCT01294319|B9|Baseline|Total|Total of all reporting groups
282374|NCT01294319|B8|Baseline|Endurance-trained Young Athletes,PCMS|Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone
282375|NCT01294319|B7|Baseline|Sedentary Young Adults,PCMS|Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone
282376|NCT01294319|B6|Baseline|Endurance-trained Young Athletes, CPSM|Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone
282377|NCT01294319|B5|Baseline|Sedentary Young Adults, CPSM|Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone
282378|NCT01294319|B4|Baseline|Endurance-trained Young Athletes, MSPC|Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone
282379|NCT01294319|B3|Baseline|Sedentary Young Adults, MSPC|Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone
282380|NCT01294319|B2|Baseline|Endurance-trained Young Athletes, SMCP|Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone
282381|NCT01294319|B1|Baseline|Sedentary Young Adults, SMCP|Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone
282382|NCT01294319|P8|Participant Flow|Endurance-trained Young Athletes,PCMS|Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone
282383|NCT01294319|P7|Participant Flow|Sedentary Young Adults,PCMS|Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone
282384|NCT01294319|P6|Participant Flow|Endurance-trained Young Athletes, CPSM|Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone
282385|NCT01294319|P5|Participant Flow|Sedentary Young Adults, CPSM|Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone
282386|NCT01294319|P4|Participant Flow|Endurance-trained Young Athletes, MSPC|Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone
282387|NCT01294319|P3|Participant Flow|Sedentary Young Adults, MSPC|Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone
282388|NCT01294319|P2|Participant Flow|Endurance-trained Young Athletes, SMCP|Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone
282389|NCT01294319|P1|Participant Flow|Sedentary Young Adults, SMCP|Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone
282390|NCT01294319|O2|Outcome|Sedentary Young Adults|"Sedentary young adults group consists of 19 subjects, each subject was randomized to one of the following four arms:~Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone~Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone~Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone~Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone"
282391|NCT01294319|O1|Outcome|Endurance-trained Young Athletes|"Endurance-trained young athletes group consists of 20 subjects, each subject was randomized to one of the following four arms:~Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone~Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone~Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone~Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone"
282392|NCT01294319|O2|Outcome|Sedentary Young Adults|"Sedentary young adults group consists of 19 subjects, each subject was randomized to one of the following four arms:~Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone~Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone~Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone~Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone"
282422|NCT01294241|O1|Outcome|Oleogel-S10 and Non-adhesive Wound Dressing|One half of an EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size was treated with Oleogel-S10 and non-adhesive wound dressing.
282423|NCT01294241|O2|Outcome|Non-adhesive Wound Dressing Only|The other half of an EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size was treated with non-adhesive wound Dressing only as control.
282393|NCT01294319|O1|Outcome|Endurance-trained Young Athletes|"Endurance-trained Young Athletes group consists of 20 subjects, each subject was randomized to one of the following four arms:~Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone~Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone~Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone~Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone"
282394|NCT01294319|E2|Reported Event|Atheletes|"Endurance-trained Young Athletes group consists of 20 subjects, each subject was randomized to one of the following four arms:~Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone"
282395|NCT01294319|E1|Reported Event|Sedentary Young Adults|"Sedentary young adults group consists of 19 subjects, each subject was randomized to one of the following four arms:~Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone"
282396|NCT01294306|B3|Baseline|Total|Total of all reporting groups
282397|NCT01294306|B2|Baseline|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
282398|NCT01294306|B1|Baseline|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
282399|NCT01294306|P2|Participant Flow|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
282400|NCT01294306|P1|Participant Flow|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
282401|NCT01294306|O2|Outcome|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
282402|NCT01294306|O1|Outcome|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
282403|NCT01294306|O2|Outcome|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
282404|NCT01294306|O1|Outcome|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
282405|NCT01294306|O2|Outcome|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
282406|NCT01294306|O1|Outcome|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
282407|NCT01294306|O2|Outcome|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
282408|NCT01294306|O1|Outcome|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
282409|NCT01294306|O2|Outcome|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
282410|NCT01294306|O1|Outcome|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
282411|NCT01294306|E2|Reported Event|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
282412|NCT01294306|E1|Reported Event|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
282413|NCT01294267|B1|Baseline|Circulatory Support System|Percutaneous use of left ventricular assist device, Impella 2.5 Circulatory Support System to facilitate mapping and ablation of ongoing VT by maintaining near-normal hemodynamics, reducing myocardial workload and preservice organ perfusion.
282414|NCT01294267|P1|Participant Flow|Circulatory Support System|Percutaneous use of left ventricular assist device, Impella 2.5 Circulatory Support System to facilitate mapping and ablation of ongoing VT by maintaining near-normal hemodynamics, reducing myocardial workload and preservice organ perfusion.
282415|NCT01294267|O1|Outcome|Circulatory Support System|"Percutaneous use of left ventricular assist device, Impella 2.5 Circulatory Support System to facilitate mapping and ablation of ongoing VT by maintaining near-normal hemodynamics, reducing myocardial workload and preservice organ perfusion.~Circulatory Support System: Femoral angiography will be performed, and if the anatomy is suitable, the femoral artery preclosure technique will be employed. The Impella 2.5 will be inserted through th femoral artery into the left ventricle. Anti-coagulation will be titrated to achieve a therapeutic ACT level. Organ perfusion and Hemodynamic data will be collected during simulated VTs and throughout the course of the case. The performance level of the device may be adjusted during the case to quantify hemodynamic effects"
282416|NCT01294267|O1|Outcome|Circulatory Support System|"Percutaneous use of left ventricular assist device, Impella 2.5 Circulatory Support System to facilitate mapping and ablation of ongoing VT by maintaining near-normal hemodynamics, reducing myocardial workload and preservice organ perfusion.~Circulatory Support System: Femoral angiography will be performed, and if the anatomy is suitable, the femoral artery preclosure technique will be employed. The Impella 2.5 will be inserted through th femoral artery into the left ventricle. Anti-coagulation will be titrated to achieve a therapeutic ACT level. Organ perfusion and Hemodynamic data will be collected during simulated VTs and throughout the course of the case. The performance level of the device may be adjusted during the case to quantify hemodynamic effects"
282417|NCT01294267|O1|Outcome|Circulatory Support System|"Percutaneous use of left ventricular assist device, Impella 2.5 Circulatory Support System to facilitate mapping and ablation of ongoing VT by maintaining near-normal hemodynamics, reducing myocardial workload and preservice organ perfusion.~Circulatory Support System: Femoral angiography will be performed, and if the anatomy is suitable, the femoral artery preclosure technique will be employed. The Impella 2.5 will be inserted through th femoral artery into the left ventricle. Anti-coagulation will be titrated to achieve a therapeutic ACT level. Organ perfusion and Hemodynamic data will be collected during simulated VTs and throughout the course of the case. The performance level of the device may be adjusted during the case to quantify hemodynamic effects"
282418|NCT01294267|E1|Reported Event|Circulatory Support System|Percutaneous use of left ventricular assist device, Impella 2.5 Circulatory Support System to facilitate mapping and ablation of ongoing VT by maintaining near-normal hemodynamics, reducing myocardial workload and preservice organ perfusion.
282419|NCT01294241|B1|Baseline|All Study Participants|One (half of an) EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size was treated with Oleogel-S10 and non-adhesive wound dressing. The other wound (half) was covered with a non-adhesive wound dressing only (Mepilex®) as control.
282420|NCT01294241|P1|Participant Flow|All Study Participants|One (half of an) EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size was treated with Oleogel-S10 and non-adhesive wound dressing. The other wound (half) was covered with a non-adhesive wound dressing only (Mepilex®) as control (intra-individual comparison).
282610|NCT01292928|O2|Outcome|Innova Stent Entire Matrix (20-200 mm)|Entire Matrix Stent implantation into SFA/PPA
326776|NCT01181011|O2|Outcome|Telmisartan 80mg|
282424|NCT01294241|O1|Outcome|Oleogel-S10 and Non-adhesive Wound Dressing|One half of an EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size was treated with Oleogel-S10 and non-adhesive wound dressing.
282425|NCT01294241|O1|Outcome|All Study Participants|Intra-individual comparison of two treatments: One half of an EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size was treated with Oleogel-S10 and non-adhesive wound dressing. The other wound (half) was covered with a non-adhesive wound dressing only (Mepilex®) as standard of care control.
282426|NCT01294241|E1|Reported Event|Safety Population|All participants who received at least 1 dose of Oleogel-S10 were included in the safety population. All adverse events were reported for all study participants. Localized adverse events were not separately reported by intervention.
282427|NCT01294228|B1|Baseline|Clinical Study Population|All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
282428|NCT01294228|P1|Participant Flow|Clinical Study Population|All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
282429|NCT01294228|O1|Outcome|Clinical Study Population|All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
282430|NCT01294228|E1|Reported Event|Clinical Study Population|All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
282431|NCT01294163|B4|Baseline|Total|Total of all reporting groups
282432|NCT01294163|B3|Baseline|TIVA|Anesthetic agent before and after CPB: propofol
282433|NCT01294163|B2|Baseline|Sevoflurane|Anesthetic agent before and after CPB: sevoflurane
282434|NCT01294163|B1|Baseline|Xenon|Anesthetic agent before and after CPB: xenon
282435|NCT01294163|P3|Participant Flow|TIVA|Anesthetic agent before and after CPB: propofol
282436|NCT01294163|P2|Participant Flow|Sevoflurane|Anesthetic agent before and after CPB: sevoflurane
282437|NCT01294163|P1|Participant Flow|Xenon Including Pilot Patients|Anesthetic agent before and after CPB: xenon
282438|NCT01294163|O2|Outcome|Sevoflurane|Anesthetic agent before and after CPB: sevoflurane
282439|NCT01294163|O1|Outcome|Xenon|Anesthetic agent before and after CPB: xenon
282440|NCT01294163|O2|Outcome|Sevoflurane|Anesthetic agent before and after CPB: sevoflurane
282441|NCT01294163|O1|Outcome|Xenon|Anesthetic agent before and after CPB: xenon
282442|NCT01294163|E3|Reported Event|TIVA|Anesthetic agent before and after CPB: propofol
282443|NCT01294163|E2|Reported Event|Sevoflurane|Anesthetic agent before and after CPB: sevoflurane
282444|NCT01294163|E1|Reported Event|Xenon Including Pilot Patients|Anesthetic agent before and after CPB: xenon
282445|NCT01294150|B3|Baseline|Total|Total of all reporting groups
282446|NCT01294150|B2|Baseline|Cystoscopy|Sham treatment entailed rigid cystoscopy, a blinding screen and sounds that mimicked those of the prostatic urethral lift procedure.
282447|NCT01294150|B1|Baseline|UroLift System|Average of 4.9 implants per prostate implanted. The prostatic urethral lift is performed by placing permanent transprostatic implants to lift apart the prostate lobes and reduce urethral obstruction.
282448|NCT01294150|P2|Participant Flow|Cystoscopy (Control/Sham)|The control group subjects underwent a cystoscopy procedure. The subject was blinded as to whether he was randomized to the control or treatment group. Unblinding occurred at 3 months post procedure after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo procedure with the UroLift system, provided he met the inclusion and exclusion criteria. Subjects crossing over are then to be followed for 5 years post-treatment. If subject did not crossover, his participation was not required beyond the 12 month visit.
282449|NCT01294150|P1|Participant Flow|UroLift System|The treatment group subjects underwent the UroLift (UL)system procedure. The subject was blinded as to whether he was in the control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to be retreated with the UroLift system if he met the retreatment inclusion and exclusion criteria. Subjects that went on to UL retreatment within the first 12 months were considered treatment failures, but started their follow-up schedule over. All subjects will be followed at a minimum of 5 years per the assessment schedule.
282450|NCT01294150|O1|Outcome|UroLift System|The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. All subjects will be followed at a minimum of 5 years per the assessment schedule.
282451|NCT01294150|O1|Outcome|UroLift System|The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. All subjects will be followed at a minimum of 5 years per the assessment schedule.
282452|NCT01294150|O2|Outcome|Cystoscopy|The control group subjects underwent a cystoscopy procedure only. The subject was blinded as to whether he was in the control or treatment group. Unblinding occurred at 3 months after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo the UroLift system procedure if he met inclusion and exclusion criteria. Subjects who crossed over will then be followed for 5 years post-treatment. The subjects that did not crossover were not required to participate beyond 12 months.
282453|NCT01294150|O1|Outcome|UroLift System|The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. All subjects will be followed at a minimum of 5 years per the assessment schedule.
282454|NCT01294150|O1|Outcome|UroLift System|The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. No matter which retreatment therapy, all subjects will be followed at a minimum of 5 years per the assessment schedule.
282487|NCT01294046|O1|Outcome|Deep Brain Stimulation Arm Group|"Electrical Stimulation of SPG for Treatment of Migraine~Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches"
282644|NCT01292642|O2|Outcome|PostTreatment - Cigarettes Per Day|CBT plus NRT
282455|NCT01294150|E3|Reported Event|Cystoscopy|The control group subjects underwent a cystoscopy procedure only. The subject was blinded as to whether he was in the control or treatment group. Unblinding occurred at 3 months after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo the UroLift system procedure if he met inclusion and exclusion criteria. Subjects who crossed over will then be followed for 5 years post-treatment. The subjects that did not crossover were not required to participate beyond 12 months.
282456|NCT01294150|E2|Reported Event|Crossover|Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo the UroLift system procedure if he met inclusion and exclusion criteria. Subjects who crossed over will then be followed for 5 years post-treatment. The subjects that did not crossover were not required to participate beyond 12 months.
282457|NCT01294150|E1|Reported Event|UroLift System|The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. All subjects will be followed at a minimum of 5 years per the assessment schedule.
282458|NCT01294098|B4|Baseline|Total|Total of all reporting groups
282459|NCT01294098|B3|Baseline|PCA + Hematoma Block|"patient will receive hematoma block during surgery~Marcaine: 0.75 cc/kg of 1/4% Marcaine"
282460|NCT01294098|B2|Baseline|PCA and Femoral Nerve Block|"this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively~Marcaine: 0.75 cc/kg of 1/4% Marcaine"
282461|NCT01294098|B1|Baseline|PCA Only|this group will only get a pain control anesthesia pump to use for post-operative pain
282462|NCT01294098|P3|Participant Flow|PCA + Hematoma Block|"patient will receive hematoma block during surgery~Marcaine: 0.75 cc/kg of 1/4% Marcaine"
282463|NCT01294098|P2|Participant Flow|PCA and Femoral Nerve Block|"this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively~Marcaine: 0.75 cc/kg of 1/4% Marcaine"
282464|NCT01294098|P1|Participant Flow|PCA Only|this group will only get a pain control anesthesia pump to use for post-operative pain
282465|NCT01294098|O3|Outcome|PCA + Hematoma Block|"patient will receive hematoma block during surgery~Marcaine: 0.75 cc/kg of 1/4% Marcaine"
282466|NCT01294098|O2|Outcome|PCA and Femoral Nerve Block|"this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively~Marcaine: 0.75 cc/kg of 1/4% Marcaine"
282467|NCT01294098|O1|Outcome|PCA Only|this group will only get a pain control anesthesia pump to use for post-operative pain
282468|NCT01294098|O3|Outcome|PCA + Hematoma Block|"patient will receive hematoma block during surgery~Marcaine: 0.75 cc/kg of 1/4% Marcaine"
282469|NCT01294098|O2|Outcome|PCA and Femoral Nerve Block|"this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively~Marcaine: 0.75 cc/kg of 1/4% Marcaine"
282470|NCT01294098|O1|Outcome|PCA Only|this group will only get a pain control anesthesia pump to use for post-operative pain
282471|NCT01294098|O3|Outcome|PCA + Hematoma Block|"patient will receive hematoma block during surgery~Marcaine: 0.75 cc/kg of 1/4% Marcaine"
282472|NCT01294098|O2|Outcome|PCA and Femoral Nerve Block|"this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively~Marcaine: 0.75 cc/kg of 1/4% Marcaine"
282473|NCT01294098|O1|Outcome|PCA Only|this group will only get a pain control anesthesia pump to use for post-operative pain
282474|NCT01294098|E3|Reported Event|PCA + Hematoma Block|"patient will receive hematoma block during surgery~Marcaine: 0.75 cc/kg of 1/4% Marcaine"
282475|NCT01294098|E2|Reported Event|PCA and Femoral Nerve Block|"this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively~Marcaine: 0.75 cc/kg of 1/4% Marcaine"
282476|NCT01294098|E1|Reported Event|PCA Only|this group will only get a pain control anesthesia pump to use for post-operative pain
282477|NCT01294046|B1|Baseline|Deep Brain Stimulation Arm Group|"Electrical Stimulation of SPG for Treatment of Migraine~Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches"
282478|NCT01294046|P1|Participant Flow|Deep Brain Stimulation Arm Group|"Electrical Stimulation of SPG for Treatment of Migraine~Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches"
282479|NCT01294046|O1|Outcome|Deep Brain Stimulation of SPG for Migraine|"Electrical SPG for Treatment of Migraine~Deep Brain Stimulation of SPG for Migraine: Deep Brain Stimulation of SPG for Migraine~No data were collected from this entire study, so no data were analyzed."
282480|NCT01294046|O1|Outcome|Deep Brain Stimulation of SPG for Migraine|"Electrical SPG for Treatment of Migraine~Deep Brain Stimulation of SPG for Migraine: Deep Brain Stimulation of SPG for Migraine~No data were collected from this entire study, so no data were analyzed."
282481|NCT01294046|O1|Outcome|Deep Brain Stimulation of SPG for Migraine|"Electrical SPG for Treatment of Migraine~Deep Brain Stimulation of SPG for Migraine: Deep Brain Stimulation of SPG for Migraine~No data were collected from this entire study, so no data were analyzed."
282482|NCT01294046|O1|Outcome|Deep Brain Stimulation of SPG for Migraine|"Electrical SPG for Treatment of Migraine~Deep Brain Stimulation of SPG for Migraine: Deep Brain Stimulation of SPG for Migraine~No data were collected from this entire study, so no data were analyzed."
282483|NCT01294046|O1|Outcome|Deep Brain Stimulation of SPG for Migraine|"Electrical SPG for Treatment of Migraine~Deep Brain Stimulation of SPG for Migraine: Deep Brain Stimulation of SPG for Migraine~No data were collected from this entire study, so no data were analyzed."
282484|NCT01294046|O1|Outcome|Deep Brain Stimulation Arm Group|"Electrical Stimulation of SPG for Treatment of Migraine~Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches"
282485|NCT01294046|O1|Outcome|Deep Brain Stimulation of SPG for Migraine|"Electrical SPG for Treatment of Migraine~Deep Brain Stimulation of SPG for Migraine: Deep Brain Stimulation of SPG for Migraine~No outcome measure data was analyzed because no outcome data were collected."
282486|NCT01294046|O1|Outcome|Experimental: Deep Brain Stimulation Arm Group|"Experimental: Deep brain stimulation arm group~Electrical Stimulation of SPG for Treatment of Migraine"
282542|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
282488|NCT01294046|O1|Outcome|Deep Brain Stimulation Arm Group|"Electrical Stimulation of SPG for Treatment of Migraine~Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches"
282489|NCT01294046|E1|Reported Event|Deep Brain Stimulation Arm Group|"Electrical Stimulation of SPG for Treatment of Migraine~Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches"
282490|NCT01293968|B3|Baseline|Total|Total of all reporting groups
282491|NCT01293968|B2|Baseline|Diphenhydramine and Aluminium MgS|
282492|NCT01293968|B1|Baseline|Ibuprofen, Diphenhydramine and Aluminium MgS|
282493|NCT01293968|P2|Participant Flow|Diphenhydramine and Aluminium MgS|
282494|NCT01293968|P1|Participant Flow|Ibuprofen, Diphenhydramine and Aluminium MgS|
282495|NCT01293968|O2|Outcome|Diphenhydramine and Aluminium MgS|the group received the placebo solution containing 10 cc Diphenhydramine 25 mg and 10 cc AlMgS which was applied on the ulcers 30-60 minutes before meals, 3 times daily for 3 days
282496|NCT01293968|O1|Outcome|Ibuprofen, Diphenhydramine and Aluminium MgS|the group received the study solution containing 5cc ibuprofen 100mg, 10 cc Diphenhydramine 25 mg and 10 cc AlMgS which was applied on the ulcers 30-60 minutes before meals, 3 times daily for 3 days
282497|NCT01293968|E2|Reported Event|Diphenhydramine and Aluminium MgS|
282498|NCT01293968|E1|Reported Event|Ibuprofen, Diphenhydramine and Aluminium MgS|
282499|NCT01293825|B1|Baseline|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
282500|NCT01293825|P1|Participant Flow|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
282501|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
282502|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
282503|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
282504|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
282505|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
282506|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
282507|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
282508|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
282509|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
282510|NCT01293825|E1|Reported Event|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
282511|NCT01293695|B3|Baseline|Total|Total of all reporting groups
282512|NCT01293695|B2|Baseline|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
282513|NCT01293695|B1|Baseline|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy (HRT)~Hypnosis: Hypnosis relaxation in five weekly sessions"
282514|NCT01293695|P2|Participant Flow|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
282515|NCT01293695|P1|Participant Flow|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions"
282516|NCT01293695|O2|Outcome|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
282517|NCT01293695|O1|Outcome|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions"
282518|NCT01293695|O2|Outcome|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
282519|NCT01293695|O1|Outcome|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions."
282520|NCT01293695|O2|Outcome|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
282521|NCT01293695|O1|Outcome|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions."
282599|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
282600|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
282522|NCT01293695|O2|Outcome|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
282523|NCT01293695|O1|Outcome|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions. Weekly hot flash scores were averaged."
282524|NCT01293695|O2|Outcome|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
282525|NCT01293695|O1|Outcome|Hypnosis|"Received 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions. Weekly hot flash scores were averaged."
282526|NCT01293695|E2|Reported Event|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
282527|NCT01293695|E1|Reported Event|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions"
282528|NCT01293539|B1|Baseline|Intra-arterial Chemotherapy|"IAC is offered to all patients with intraocular Rb who are deemed eligible after evaluation under anesthesia (EUA),with the exception of those few patients for whom focal modalities (i.e., laser or cryotherapy) would be effective.In cases of bilateral disease, both eyes would be treated sequentially during the same procedure utilizing the same femoral access site.~Two cycles of IAC will be performed at 3 to 4 week intervals. Melphalan dosing: 3-6 mth-old, 2.5mg; 3-12 mth-old, 3mg; 1-3 yr-old, 4mg; >3 yr-old, 5mg. For those tumors that have shown appropriate response and are amenable to local therapies, then no additional IAC will be performed. If the tumors do not regress after 2 cycles, then a third cycle of IAC will be offered. Local therapies (laser, cryotherapy) will not be given during the EUAs conducted prior to each treatment session, but will be allowed after toxicity and response has been assessed 3-4 weeks after the final cycle of intra-arterial therapy."
282529|NCT01293539|P1|Participant Flow|Intra-arterial Chemotherapy|"IAC is offered to all patients with intraocular Rb who are deemed eligible after evaluation under anesthesia (EUA),with the exception of those few patients for whom focal modalities (i.e., laser or cryotherapy) would be effective.In cases of bilateral disease, both eyes would be treated sequentially during the same procedure utilizing the same femoral access site.~Two cycles of IAC will be performed at 3 to 4 week intervals. Melphalan dosing: 3-6 mth-old, 2.5mg; 3-12 mth-old, 3mg; 1-3 yr-old, 4mg; >3 yr-old, 5mg. For those tumors that have shown appropriate response and are amenable to local therapies, then no additional IAC will be performed. If the tumors do not regress after 2 cycles, then a third cycle of IAC will be offered. Local therapies (laser, cryotherapy) will not be given during the EUAs conducted prior to each treatment session, but will be allowed after toxicity and response has been assessed 3-4 weeks after the final cycle of intra-arterial therapy."
282530|NCT01293539|O1|Outcome|Intra-arterial Chemotherapy|"IAC is offered to all patients with intraocular Rb who are deemed eligible after evaluation under anesthesia (EUA),with the exception of those few patients for whom focal modalities (i.e., laser or cryotherapy) would be effective.In cases of bilateral disease, both eyes would be treated sequentially during the same procedure utilizing the same femoral access site.~Two cycles of IAC will be performed at 3 to 4 week intervals. Melphalan dosing: 3-6 mth-old, 2.5mg; 3-12 mth-old, 3mg; 1-3 yr-old, 4mg; >3 yr-old, 5mg. For those tumors that have shown appropriate response and are amenable to local therapies, then no additional IAC will be performed. If the tumors do not regress after 2 cycles, then a third cycle of IAC will be offered. Local therapies (laser, cryotherapy) will not be given during the EUAs conducted prior to each treatment session, but will be allowed after toxicity and response has been assessed 3-4 weeks after the final cycle of intra-arterial therapy."
282531|NCT01293539|E1|Reported Event|Intra-arterial Chemotherapy|"IAC is offered to all patients with intraocular Rb who are deemed eligible after evaluation under anesthesia (EUA),with the exception of those few patients for whom focal modalities (i.e., laser or cryotherapy) would be effective.In cases of bilateral disease, both eyes would be treated sequentially during the same procedure utilizing the same femoral access site.~Two cycles of IAC will be performed at 3 to 4 week intervals. Melphalan dosing: 3-6 mth-old, 2.5mg; 3-12 mth-old, 3mg; 1-3 yr-old, 4mg; >3 yr-old, 5mg. For those tumors that have shown appropriate response and are amenable to local therapies, then no additional IAC will be performed. If the tumors do not regress after 2 cycles, then a third cycle of IAC will be offered. Local therapies (laser, cryotherapy) will not be given during the EUAs conducted prior to each treatment session, but will be allowed after toxicity and response has been assessed 3-4 weeks after the final cycle of intra-arterial therapy."
282532|NCT01293240|B1|Baseline|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
282533|NCT01293240|P1|Participant Flow|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
282534|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
282535|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
282536|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
282537|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
282538|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
282539|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
282540|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
282541|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
282543|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
282544|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
282545|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
282546|NCT01293240|E1|Reported Event|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
282547|NCT01293084|B1|Baseline|Children With CF|Children with CF inhaled either 5 mL of 7% saline or 0.12% saline once over 20 minutes. On a second visit, the same children were crossed-over and inhaled either 0.12% saline or 7% saline over 20 minutes. The order of these visits was randomized but the sequence of the randomization is not known.
282548|NCT01293084|P1|Participant Flow|Children With CF|Children with CF inhaled either 5 mL of 7% saline or 0.12% saline once over 20 minutes. On a second visit, the same children were crossed-over and inhaled either 0.12% saline or 7% saline over 20 minutes. The order of these visits was randomized but the sequence of the randomization is not known.
282549|NCT01293084|O2|Outcome|0.12% Saline|"5mL 0.12% saline inhaled once during 20 minutes~0.12% saline: 5mL of 0.12% saline inhaled once over 20 minutes"
282550|NCT01293084|O1|Outcome|7% Saline|"5 mL of 7% saline was inhaled once over a 20 minute period.~7% saline: 5mL 7% saline inhaled once over 20 minutes"
282551|NCT01293084|O2|Outcome|0.12% Saline|"5mL 0.12% saline inhaled once during 20 minutes~0.12% saline: 5mL of 0.12% saline inhaled once over 20 minutes"
282552|NCT01293084|O1|Outcome|7% Saline|"5 mL of 7% saline was inhaled once over a 20 minute period.~7% saline: 5mL 7% saline inhaled once over 20 minutes"
282553|NCT01293084|E2|Reported Event|0.12% Saline|"5mL 0.12% saline inhaled once during 20 minutes~0.12% saline: 5mL of 0.12% saline inhaled once over 20 minutes"
282554|NCT01293084|E1|Reported Event|7% Saline|"5 mL of 7% saline was inhaled once over a 20 minute period.~7% saline: 5mL 7% saline inhaled once over 20 minutes"
282555|NCT01293032|B5|Baseline|Total|Total of all reporting groups
282556|NCT01293032|B4|Baseline|Group 3 (RS > 25)|"Patients with a high RS (> 25) were assigned to Group 3. They received chemotherapy, neoadjuvant chemotherapy as in Group 2 Arm 2.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/Oncotype DX Gene Expression Profiling System~Systemic chemotherapy"
282557|NCT01293032|B3|Baseline|Group 2 Arm 2 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 2 they received 6-8 courses of neoadjuvant chemotherapy comprised of anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/Oncotype DX Gene Expression Profiling System~Systemic chemotherapy"
282558|NCT01293032|B2|Baseline|Group 2 Arm 1 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 1 they received neoadjuvant hormonal therapy as in Group 1.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System~Hormonal therapy:~Tamoxifen Citrate (pre-menopausal women) OR~Aromatase Inhibition Therapy (post-menopausal women)"
282559|NCT01293032|B1|Baseline|Group 1 (RS < 11)|"Patients with a Recurrence Score (RS) of less than 11 were assigned to Group 1. They received neoadjuvant hormonal therapy comprised of tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System~Hormonal therapy:~Tamoxifen Citrate (pre-menopausal women) OR~Aromatase Inhibition Therapy (post-menopausal women)"
282560|NCT01293032|P4|Participant Flow|Group 3 (RS > 25)|"Patients with a high RS (> 25) were assigned to Group 3. They received chemotherapy, neoadjuvant chemotherapy as in Group 2 Arm 2.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/Oncotype DX Gene Expression Profiling System~Systemic chemotherapy"
282561|NCT01293032|P3|Participant Flow|Group 2 Arm 2 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 2 they received 6-8 courses of neoadjuvant chemotherapy comprised of anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/Oncotype DX Gene Expression Profiling System~Systemic chemotherapy"
282562|NCT01293032|P2|Participant Flow|Group 2 Arm 1 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 1 they received neoadjuvant hormonal therapy as in Group 1.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System~Hormonal therapy:~Tamoxifen Citrate (pre-menopausal women) OR~Aromatase Inhibition Therapy (post-menopausal women)"
282563|NCT01293032|P1|Participant Flow|Group 1 (RS < 11)|"Patients with a RS of less than 11 were assigned to Group 1. They received neoadjuvant hormonal therapy comprised of tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System~Hormonal therapy:~Tamoxifen Citrate (pre-menopausal women) OR~Aromatase Inhibition Therapy (post-menopausal women)"
282564|NCT01293032|O1|Outcome|Group 2 (RS 11-25)|Patients with an intermediate RS (11-25) were assigned to Group 2. The subject was then randomized to treatment Arm 1, neoadjuvant hormonal therapy, or treatment Arm 2, neoadjuvant chemotherapy.
282565|NCT01293032|E4|Reported Event|Group 3 (RS > 25)|"Patients with a high RS (> 25) were assigned to Group 3. They received chemotherapy, neoadjuvant chemotherapy as in Group 2 Arm 2.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/Oncotype DX Gene Expression Profiling System~Systemic chemotherapy"
282601|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
282566|NCT01293032|E3|Reported Event|Group 2 Arm 2 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 2 they received 6-8 courses of neoadjuvant chemotherapy comprised of anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/Oncotype DX Gene Expression Profiling System~Systemic chemotherapy"
282567|NCT01293032|E2|Reported Event|Group 2 Arm 1 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 1 they received neoadjuvant hormonal therapy as in Group 1.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System~Hormonal therapy:~Tamoxifen Citrate (pre-menopausal women) OR~Aromatase Inhibition Therapy (post-menopausal women)"
282568|NCT01293032|E1|Reported Event|Group 1 (RS < 11)|"Patients with a Recurrence Score (RS) of less than 11 were assigned to Group 1. They received neoadjuvant hormonal therapy comprised of tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System~Hormonal therapy:~Tamoxifen Citrate (pre-menopausal women) OR~Aromatase Inhibition Therapy (post-menopausal women)"
282569|NCT01293006|B5|Baseline|Total|Total of all reporting groups
282570|NCT01293006|B4|Baseline|Placebo Then Suvorexant (30 mg)|During Period 1, participants ≥65 years of age received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants were administered a 30-mg oral dose of suvorexant once daily for 4 consecutive days in the evening.
282571|NCT01293006|B3|Baseline|Placebo Then Suvorexant (40 mg)|During Period 1, participants <65 years of age received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening.
282572|NCT01293006|B2|Baseline|Suvorexant (30 mg) Then Placebo|During Period 1, participants ≥65 years of age were administered a 30-mg oral dose of MK-suvorexant once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening.
282573|NCT01293006|B1|Baseline|Suvorexant (40 mg) Then Placebo|During Period 1, participants <65 years of age were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening. A washout period of, at least, 7 days followed Period 1. During Period 2, participants received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening.
282574|NCT01293006|P4|Participant Flow|Placebo Then Suvorexant (30 mg)|During Period 1, participants ≥65 years of age received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants were administered a 30-mg oral dose of suvorexant once daily for 4 consecutive days in the evening.
282575|NCT01293006|P3|Participant Flow|Placebo Then Suvorexant (40 mg)|During Period 1, participants <65 years of age received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening.
282576|NCT01293006|P2|Participant Flow|Suvorexant (30 mg) Then Placebo|During Period 1, participants ≥65 years of age were administered a 30-mg oral dose of suvorexant once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening.
282577|NCT01293006|P1|Participant Flow|Suvorexant (40 mg) Then Placebo|During Period 1, participants <65 years of age were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening.
282578|NCT01293006|O2|Outcome|Placebo|Participants administered placebo.
282579|NCT01293006|O1|Outcome|Suvorexant (40 mg or 30 mg)|Participants administered either a 40-mg or a 30-mg dose of suvorexant.
282580|NCT01293006|O2|Outcome|Placebo|Participants administered placebo.
282581|NCT01293006|O1|Outcome|Suvorexant (30 mg or 40 mg)|Participants administered either a 40-mg or a 30-mg dose of suvorexant.
282582|NCT01293006|O2|Outcome|Placebo|Participants administered placebo.
282583|NCT01293006|O1|Outcome|Suvorexant (30 mg or 40 mg)|Participants administered either a 40-mg or 30-mg dose of suvorexant.
282584|NCT01293006|O2|Outcome|Placebo|Participants receiving placebo.
282585|NCT01293006|O1|Outcome|Suvorexant (30 mg or 40 mg)|Participants receiving either a 40-mg or 30-mg dose of suvorexant.
282586|NCT01293006|O3|Outcome|Placebo|Participants administered placebo.
282587|NCT01293006|O2|Outcome|Suvorexant (30 mg)|Participants administered a 30-mg oral dose of suvorexant.
282588|NCT01293006|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg oral dose of suvorexant.
282589|NCT01293006|O3|Outcome|Placebo|Participants administered placebo.
282590|NCT01293006|O2|Outcome|Suvorexant (30 mg)|Participants administered a 30-mg oral dose of suvorexant.
282591|NCT01293006|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg oral dose of suvorexant.
282592|NCT01293006|O2|Outcome|Placebo|Participants administered placebo.
282593|NCT01293006|O1|Outcome|Suvorexant (30 mg or 40 mg)|Participants administered either a 40-mg or a 30-mg oral dose of suvorexant.
282594|NCT01293006|E3|Reported Event|Placebo|Participants administered placebo.
282595|NCT01293006|E2|Reported Event|Suvorexant (30 mg)|Participants administered a 30-mg oral dose of suvorexant.
282596|NCT01293006|E1|Reported Event|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
282597|NCT01292928|B1|Baseline|Innova Stent|Stent implantation into SFA/PPA
282598|NCT01292928|P1|Participant Flow|Innova Stent|Stent implantation into Superficial Femoral Artery (SFA) / Proximal Popliteal Artery (PPA)
282611|NCT01292928|O1|Outcome|Innova Stent Core Matrix (20-150 mm)|Core Matrix Stent implantation into SFA/PPA
282612|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
282613|NCT01292928|E1|Reported Event|Innova Stent|Stent implantation into SFA/PPA
282614|NCT01292876|B1|Baseline|Extracellular Matrix|"Implantation of Extracellular Matrix~Extracellular Matrix: Extracellular Matrix"
282615|NCT01292876|P1|Participant Flow|Extracellular Matrix|Overall number of participants for which baseline characteristics were measured for all baseline measures reported..
282616|NCT01292876|O1|Outcome|Extracellular Matrix|Overall number of participants for which characteristics were measured for all measures reported..
282617|NCT01292876|O1|Outcome|Extracellular Matrix|Participants for which final characteristics and functional evaluations were measured for all measures reported.
282618|NCT01292876|E2|Reported Event|Extracellular Matrix_Exp|Experimental group; post implantation of ECM
282619|NCT01292876|E1|Reported Event|Extracellular Matrix_Control|Control (prior to implantation of ECM)
282620|NCT01292837|B1|Baseline|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
282621|NCT01292837|P1|Participant Flow|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
282622|NCT01292837|O1|Outcome|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
282623|NCT01292837|O1|Outcome|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
282624|NCT01292837|O1|Outcome|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
282625|NCT01292837|O1|Outcome|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
282626|NCT01292837|O1|Outcome|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
282627|NCT01292837|O1|Outcome|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
282628|NCT01292837|E1|Reported Event|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
282629|NCT01292798|B1|Baseline|2.0 mg Ranibizumab|Subjects who presented with persistent DME at month 3 following 3 months of monthly 0.5 mg ranibizumab injections received 3 monthly injections of 2.0 mg Ranibizumab.
282630|NCT01292798|P1|Participant Flow|2.0 mg Ranibizumab|Subjects who presented with persistent DME at month 3 following 3 months of monthly 0.5 mg ranibizumab injections received 3 monthly injections of 2.0 mg Ranibizumab.
282631|NCT01292798|O1|Outcome|0.5mg and 2.0mgRanibizumab|"Three consecutive intravitreal ranibizumab 0.5mg injections followed by three consecutive intravitreal ranibizumab 2.0mg injections if specific criteria is met.~Ranibizumab: 0.05ml of 0.5mg or 2.0mg ranibizumab injected intravitreally"
282632|NCT01292798|O1|Outcome|0.5mg and 2.0mgRanibizumab|"Three consecutive intravitreal ranibizumab 0.5mg injections followed by three consecutive intravitreal ranibizumab 2.0mg injections if specific criteria is met.~Ranibizumab: 0.05ml of 0.5mg or 2.0mg ranibizumab injected intravitreally"
282633|NCT01292798|O1|Outcome|0.5mg and 2.0mgRanibizumab|"Three consecutive intravitreal ranibizumab 0.5mg injections followed by three consecutive intravitreal ranibizumab 2.0mg injections if specific criteria is met.~Ranibizumab: 0.05ml of 0.5mg or 2.0mg ranibizumab injected intravitreally"
282634|NCT01292798|E1|Reported Event|2.0 mg Ranibizumab|Subjects who presented with persistent DME at month 3 following 3 months of monthly 0.5 mg ranibizumab injections received 3 monthly injections of 2.0 mg Ranibizumab.
282635|NCT01292746|B1|Baseline|Erchonia MLS|The Erchonia MLS administers 4 diodes of 10 milliwatts (mW) 635 nanometers (nm) red light to the scalp area for 18 minutes, 2 times each week for 12 consecutive weeks for a total of 24 treatments.
282636|NCT01292746|P1|Participant Flow|Erchonia MLS|Erchonia MLS employs four diodes emitting 10 milliwatts (mW) 635 nanometer (nm) red laser light.
282637|NCT01292746|O1|Outcome|Erchonia MLS|Erchonia MLS: The Erchonia MLS administers 4 diodes of 10 milliwatts (mW) 635 nanometers (nm) red light to the scalp area for 18 minutes, 2 times each week for 12 consecutive weeks for a total of 24 treatments.
282638|NCT01292746|E1|Reported Event|Erchonia MLS|The Erchonia MLS administers 4 diodes of 10 milliwatts (mW) 635 nanometers (nm) red light to the scalp area for 18 minutes, 2 times each week for 12 consecutive weeks for a total of 24 treatments.
282639|NCT01292642|B1|Baseline|Treatment|CBT plus NRT
282640|NCT01292642|P1|Participant Flow|Treatment|Cognitive behavioral therapy (CBT) plus transdermal patch nicotine replacement therapy (NRT) to treat co-occurring nicotine and cannabis dependence during a 10-week study.
282641|NCT01292642|O1|Outcome|Treatment|CBT plus NRT
282642|NCT01292642|O2|Outcome|Post Treatment - Cannabis Inhalations Per Day|
282643|NCT01292642|O1|Outcome|Baseline - Cannabis Inhalations Per Day|CBT plus NRT
282647|NCT01292629|B1|Baseline|iSert® 251 Intraocular Lens|Population Description: A total of 125 subjects were implanted with the iSert® IOL. Data analysis for baseline characteristics was completed on these 125 subjects.
282648|NCT01292629|P1|Participant Flow|iSert 251: iSert 251 Intraocular Lens|Implantation with the iSert® 251 Intraocular lens
282649|NCT01292629|O1|Outcome|iSert 251 Aphakik IOL|iSert 251: iSert 251 intraocular lens
282650|NCT01292629|O1|Outcome|iSert 251: iSert 251 Intraocular Lens|Eligible subjects underwent phacoemulsification cataract extraction surgery and were implanted with the iSert® Intraocular Lens. Study observation was up to 271 days.
282651|NCT01292629|E1|Reported Event|iSert 251: iSert 251 Intraocular Lens|Subjects who underwent phacoemulsification cataract extraction surgery who were implanted with the iSert aphakic intraocular lens.
282652|NCT01292603|B6|Baseline|Total|Total of all reporting groups
282653|NCT01292603|B5|Baseline|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282654|NCT01292603|B4|Baseline|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282655|NCT01292603|B3|Baseline|Part 1: Rituximab SC 1870 mg|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282656|NCT01292603|B2|Baseline|Part 1: Rituximab SC 1600 mg|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282657|NCT01292603|B1|Baseline|Part 1: Rituximab SC 1400 Milligrams (mg)|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with fludarabine/cyclophosphamide (FC) prior to Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282658|NCT01292603|P6|Participant Flow|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282659|NCT01292603|P5|Participant Flow|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282660|NCT01292603|P4|Participant Flow|No SC Dose Received|These participants were withdrawn prior to SC treatment.
282661|NCT01292603|P3|Participant Flow|Part 1: Rituximab SC 1870 mg|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282662|NCT01292603|P2|Participant Flow|Part 1: Rituximab SC 1600 mg|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282663|NCT01292603|P1|Participant Flow|Part 1: Rituximab SC 1400 Milligrams (mg)|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with fludarabine/cyclophosphamide (FC) prior to Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 milligrams per square meter (mg/m^2) on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282664|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282665|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282666|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282667|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282668|NCT01292603|O5|Outcome|No SC Dose Received|These participants were withdrawn prior to SC treatment.
282669|NCT01292603|O4|Outcome|Rituximab SC 1000 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282670|NCT01292603|O3|Outcome|Part 1: Rituximab SC 1870 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282671|NCT01292603|O2|Outcome|Part 1: Rituximab SC 1600 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282672|NCT01292603|O1|Outcome|Part 1: Rituximab SC 1400 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282673|NCT01292603|O5|Outcome|No SC Dose Received|These participants were withdrawn prior to SC treatment.
282674|NCT01292603|O4|Outcome|Part 1: Rituximab SC 1000 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282675|NCT01292603|O3|Outcome|Part 1: Rituximab SC 1870 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282676|NCT01292603|O2|Outcome|Part 1: Rituximab SC 1600 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282677|NCT01292603|O1|Outcome|Part 1: Rituximab SC 1400 Milligrams (mg)|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282678|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282715|NCT01292486|B1|Baseline|Patients With Multiple Myeloma|Multiple myeloma patients requiring myeloablative therapy and a first autologous hematopoetic stem cell transplant.
282866|NCT01292135|O2|Outcome|PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI-32765: 420 mg daily
326777|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
282679|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282680|NCT01292603|O1|Outcome|Part 1: Rituximab SC|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282681|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282682|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282683|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282684|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282685|NCT01292603|O3|Outcome|Part 1: Rituximab SC 1870 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282686|NCT01292603|O2|Outcome|Part 1: Rituximab SC 1600 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282687|NCT01292603|O1|Outcome|Part 1: Rituximab SC 1400 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with fludarabine/cyclophosphamide (FC) prior to Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282688|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282689|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282690|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282691|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282692|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282693|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282694|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282695|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282696|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282697|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282698|NCT01292603|O1|Outcome|Part 1: Rituximab SC|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282699|NCT01292603|E7|Reported Event|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282700|NCT01292603|E6|Reported Event|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282701|NCT01292603|E5|Reported Event|No SC Dose Received|These participants were withdrawn prior to SC treatment.
282702|NCT01292603|E4|Reported Event|Part 1: Rituximab SC 1000 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282703|NCT01292603|E3|Reported Event|Part 1: Rituximab SC 1870 mg|"PParticipant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282704|NCT01292603|E2|Reported Event|Part 1: Rituximab SC 1600 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282705|NCT01292603|E1|Reported Event|Part 1: Rituximab SC 1400 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
282706|NCT01292538|B3|Baseline|Total|Total of all reporting groups
282707|NCT01292538|B2|Baseline|Placebo Laser|"Sham light output with no therapeutic benefit~Placebo laser: Sham light output with no therapeutic benefit"
282708|NCT01292538|B1|Baseline|Erchonia GLS 532nm|"532nm green laser light therapy.~Erchonia GLS: 532 nm green diode low level laser light device"
282709|NCT01292538|P2|Participant Flow|Placebo Laser|"Sham light output with no therapeutic benefit~Placebo laser: Sham light output with no therapeutic benefit"
282710|NCT01292538|P1|Participant Flow|Erchonia GLS 532nm|"532nm green laser light therapy.~Erchonia GLS: 532 nm green diode low level laser light device"
282711|NCT01292538|O2|Outcome|Placebo Laser|"Sham light output with no therapeutic benefit~Placebo laser: Sham light output with no therapeutic benefit"
282712|NCT01292538|O1|Outcome|Erchonia GLS 532nm|"532nm green laser light therapy.~Erchonia GLS: 532 nm green diode low level laser light device"
282713|NCT01292538|E2|Reported Event|Placebo Laser|"Sham light output with no therapeutic benefit~Placebo laser: Sham light output with no therapeutic benefit"
282714|NCT01292538|E1|Reported Event|Erchonia GLS 532nm|"532nm green laser light therapy.~Erchonia GLS: 532 nm green diode low level laser light device"
282716|NCT01292486|P1|Participant Flow|All Per Protocol Patients|This was a single arm study, which evaluated Multiple Myeloma patients who received autologous stem-cell transplants collected using the Spectra Optia Apheresis System, following myeloablative therapy. The study was limited to subjects who were expected to demonstrate normal neutrophil recovery.
282717|NCT01292486|O1|Outcome|All Per Protocol Patients|Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
282718|NCT01292486|O1|Outcome|All Per Protocol Patients|Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
282719|NCT01292486|O1|Outcome|All Per Protocol Patients|Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
282720|NCT01292486|O1|Outcome|All Per Protocol Patients|Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
282721|NCT01292486|O1|Outcome|All Per Protocol Patients|Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
282722|NCT01292486|O1|Outcome|All Per Protocol Patients|Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
282723|NCT01292486|O1|Outcome|Patients With Multiple Myeloma|Multiple myeloma patients requiring myeloablative therapy and a first autologous hematopoetic stem cell transplant.
282724|NCT01292486|E1|Reported Event|Patients With Multiple Myeloma|Multiple myeloma patients requiring myeloablative therapy and a first autologous hematopoetic stem cell transplant.
282725|NCT01292473|B5|Baseline|Total|Total of all reporting groups
282726|NCT01292473|B4|Baseline|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks.
282727|NCT01292473|B3|Baseline|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks.
282728|NCT01292473|B2|Baseline|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks.
282729|NCT01292473|B1|Baseline|Placebo|Placebo administered subcutaneously (sc) every 4 weeks.
282730|NCT01292473|P4|Participant Flow|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks.
282731|NCT01292473|P3|Participant Flow|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks.
282732|NCT01292473|P2|Participant Flow|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks.
282733|NCT01292473|P1|Participant Flow|Placebo|Placebo subcutaneously (sc) every 4 weeks.
282734|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
282735|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
282736|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
282737|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
282738|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
282739|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
282740|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
282741|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
282742|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
282743|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
282744|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
282745|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
282746|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
282747|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
282748|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
282749|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
282750|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
282751|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
282752|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
282753|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
282754|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
282755|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
282756|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
282757|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
282758|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
282759|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
282760|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
282761|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
282762|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks.
282763|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks.
282764|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks.
282765|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks.
282766|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks.
282767|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks.
282768|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
282769|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
282770|NCT01292473|E4|Reported Event|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks.
282771|NCT01292473|E3|Reported Event|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks.
282772|NCT01292473|E2|Reported Event|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks.
282773|NCT01292473|E1|Reported Event|Placebo|Placebo administered subcutaneously (sc) every 4 weeks.
282774|NCT01292304|B1|Baseline|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
282861|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
282775|NCT01292304|P1|Participant Flow|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
282776|NCT01292304|O1|Outcome|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
282777|NCT01292304|O1|Outcome|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
282778|NCT01292304|O1|Outcome|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
282779|NCT01292304|O1|Outcome|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
282780|NCT01292304|O1|Outcome|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
282781|NCT01292304|E1|Reported Event|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
282782|NCT01292265|B1|Baseline|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
282783|NCT01292265|P1|Participant Flow|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
282784|NCT01292265|O1|Outcome|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
282785|NCT01292265|O1|Outcome|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
282786|NCT01292265|O1|Outcome|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
282787|NCT01292265|O1|Outcome|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
282788|NCT01292265|E1|Reported Event|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
282789|NCT01292239|B3|Baseline|Total|Total of all reporting groups
282790|NCT01292239|B2|Baseline|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
282791|NCT01292239|B1|Baseline|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
282792|NCT01292239|P2|Participant Flow|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
282793|NCT01292239|P1|Participant Flow|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
282794|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
282795|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
282796|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
282797|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
282798|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
282799|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
282800|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
282801|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
282802|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
282803|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
282804|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
282805|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
282806|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
282807|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
282808|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
282809|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
282810|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
282811|NCT01292239|E2|Reported Event|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
282812|NCT01292239|E1|Reported Event|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
282813|NCT01292226|B1|Baseline|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282814|NCT01292226|P1|Participant Flow|Mycophenolate Mofetil (MMF) Monotherapy|Participants received an initial dose of MMF 1 gram (g), orally (PO), twice per day (BID), started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282815|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282816|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282817|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282862|NCT01292135|O2|Outcome|PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI-32765: 420 mg daily
282863|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
326778|NCT01181011|O2|Outcome|Telmisartan 80mg|
282818|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282819|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282820|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282821|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282822|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282823|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282824|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282825|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282826|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282827|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282828|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282829|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282830|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282831|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282832|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282833|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282834|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282835|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282836|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282864|NCT01292135|O2|Outcome|PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI-32765: 420 mg daily
282837|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282838|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282839|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282840|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282841|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282842|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282843|NCT01292226|E1|Reported Event|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
282844|NCT01292187|B3|Baseline|Total|Total of all reporting groups
282845|NCT01292187|B2|Baseline|Placebo Tablets|Patients who did not receive any active treatment, just placebo
282846|NCT01292187|B1|Baseline|rsCT Tablets|Patients who received oral calcitonin as an active treatment
282847|NCT01292187|P2|Participant Flow|Oral Placebo Tablets|Identical appearing placebo tablets, without active ingredient At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime Group 1). The remaining patients enrolled were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
282848|NCT01292187|P1|Participant Flow|Oral rsCT Tablets|Tablets containing 200 μg of recombinant salmon calcitonin, for oral administration. At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime (Group 1). The remaining patients were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
282849|NCT01292187|O2|Outcome|Oral Placebo Tablets|Identical appearing placebo tablets, without active ingredient At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime Group 1). The remaining patients enrolled were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
282850|NCT01292187|O1|Outcome|Oral rsCT Tablets|Tablets containing 200 μg of recombinant salmon calcitonin, for oral administration. At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime (Group 1). The remaining patients were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
282851|NCT01292187|O2|Outcome|Oral Placebo Tablets|Identical appearing placebo tablets, without active ingredient At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime Group 1). The remaining patients enrolled were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
282852|NCT01292187|O1|Outcome|Oral Calcitonin Tablets|Tablets containing 200 μg of recombinant salmon calcitonin, for oral administration. At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime (Group 1). The remaining patients were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
282853|NCT01292187|E2|Reported Event|Oral Placebo Tablets|Identical appearing placebo tablets, without active ingredient At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime Group 1). The remaining patients enrolled were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
282854|NCT01292187|E1|Reported Event|Oral rsCT Tablets|Tablets containing 200 μg of recombinant salmon calcitonin, for oral administration. At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime (Group 1). The remaining patients were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
282855|NCT01292135|B3|Baseline|Total|Total of all reporting groups
282856|NCT01292135|B2|Baseline|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
282857|NCT01292135|B1|Baseline|PCI-32765 Plus Fludarabine/Cyclophosphamide/Rituximab (FCR)|PCI-32765: 420 mg daily
282858|NCT01292135|P2|Participant Flow|PCI-32765 Plus Bendamustine/Rituximab (BR)|"PCI-32765: 420 mg daily~BR:~Rituximab: 375 mg/m2 on Day 1 of Cycle 1 and a dose of 500 mg/m2 on Day 1 (Cycle 2 to Cycle 6).~Bendamustine; 70 mg/m² on Day 1 and 2 of each cycle (Up to 6 Cycles)"
282859|NCT01292135|P1|Participant Flow|PCI-32765 Plus Fludarabine/Cyclophosphamide/Rituximab (FCR)|"PCI-32765: 420 mg daily~FCR:~Rituximab: 375 mg/m2 on Day 1 of Cycle 1 and a dose of 500 mg/m2 on Day 1(Cycle 2 to Cycle 6).~Fludarabine: 25 mg/m2/day for 3 days (Days 1 to 3) of each cycle~Cyclophosphamide: 250 mg/m2/day for 3 days (Days 1 to 3) of each cycle (Up to 6 Cycle)"
282860|NCT01292135|O2|Outcome|PCI- 32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI-32765: 420 mg daily
282868|NCT01292135|O2|Outcome|PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI- 32765: 420 mg daily
282869|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
282870|NCT01292135|O2|Outcome|PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI- 32765: 420 mg daily
282871|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
282872|NCT01292135|O2|Outcome|PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI-32765: 420 mg daily
282873|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
282874|NCT01292135|E2|Reported Event|PCI-32765 Plus Fludarabine/ Cyclophosphamide/Rituximab (FCR)|PCI-32765: 420 mg daily
282875|NCT01292135|E1|Reported Event|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
282876|NCT01292070|B1|Baseline|Control (CAT) - Experimental (GFD)|Each participant served as their own control: the left arm received the control protein (histamine prick, intradermal diluent and intradermal standardized cat hair allergenic extract (CAT)) and right arm received the experimental protein (human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD)) administered intradermally (ID). The control arm received CAT at 0.02 milliliters (mL) of 0.01 bioequivalent allergy units (BAU)/mL to 10 BAU/mL (sequentially in 10-fold increments, stopping if dose produced a wheal ≥ 10 millimeters (mm)). The experimental arm received GFD at 0.001 BAU/mL (1/10th the dose of Fel d1 in the lowest dose of CAT) administered at 0.02 mL. Dosing continued sequentially in 10-fold increments until either a wheal of ≥ 10 mm or the maximum dose was reached (maximum of 7 dose increments).
282877|NCT01292070|P1|Participant Flow|Control (CAT) - Experimental (GFD)|Each participant served as their own control: the left arm received the control protein (histamine prick, intradermal diluent and intradermal standardized cat hair allergenic extract (CAT)) and right arm received the experimental protein (human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD)) administered intradermally (ID). The control arm received CAT at 0.02 milliliters (mL) of 0.01 bioequivalent allergy units (BAU)/mL to 10 BAU/mL (sequentially in 10-fold increments, stopping if dose produced a wheal ≥ 10 millimeters (mm)). The experimental arm received GFD at 0.001 BAU/mL (1/10th the dose of Fel d1 in the lowest dose of CAT) administered at 0.02 mL. Dosing continued sequentially in 10-fold increments until either a wheal of ≥ 10 mm or the maximum dose was reached (maximum of 7 dose increments).
282878|NCT01292070|O1|Outcome|Control (CAT) - Experimental (GFD)|Each participant served as their own control: the left arm received the control protein (histamine prick, intradermal diluent and intradermal standardized cat hair allergenic extract (CAT)) and right arm received the experimental protein (human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD)) administered intradermally (ID). The control arm received CAT at 0.02 milliliters (mL) of 0.01 bioequivalent allergy units (BAU)/mL to 10 BAU/mL (sequentially in 10-fold increments, stopping if dose produced a wheal ≥ 10 millimeters (mm)). The experimental arm received GFD at 0.001 BAU/mL (1/10th the dose of Fel d1 in the lowest dose of CAT) administered at 0.02 mL. Dosing continued sequentially in 10-fold increments until either a wheal of ≥ 10 mm or the maximum dose was reached (maximum of 7 dose increments).
282879|NCT01292070|E1|Reported Event|Control (CAT) - Experimental (GFD)|Each participant served as their own control: the left arm received the control protein (histamine prick, intradermal diluent and intradermal standardized cat hair allergenic extract (CAT)) and right arm received the experimental protein (human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD)) administered intradermally (ID). The control arm received CAT at 0.02 milliliters (mL) of 0.01 bioequivalent allergy units (BAU)/mL to 10 BAU/mL (sequentially in 10-fold increments, stopping if dose produced a wheal ≥ 10 millimeters (mm)). The experimental arm received GFD at 0.001 BAU/mL (1/10th the dose of Fel d1 in the lowest dose of CAT) administered at 0.02 mL. Dosing continued sequentially in 10-fold increments until either a wheal of ≥ 10 mm or the maximum dose was reached (maximum of 7 dose increments).
282880|NCT01292057|B3|Baseline|Total|Total of all reporting groups
282881|NCT01292057|B2|Baseline|Sugar Pill|Placebo: Placebo to match active drug Aripiprazole for 8 days
282882|NCT01292057|B1|Baseline|Aripiprazole|"Medication~Aripiprazole: Aripiprazole(up to 15 mg/day) for 8 days"
282883|NCT01292057|P2|Participant Flow|Sugar Pill|Placebo: Placebo to match active drug Aripiprazole for 8 days
282884|NCT01292057|P1|Participant Flow|Aripiprazole|"Medication~Aripiprazole: Aripiprazole(up to 15 mg/day) for 8 days"
282885|NCT01292057|O2|Outcome|Sugar Pill|Placebo: Placebo to match active drug Aripiprazole for 8 days
282886|NCT01292057|O1|Outcome|Aripiprazole|"Medication~Aripiprazole: Aripiprazole(up to 15 mg/day) for 8 days"
282887|NCT01292057|O2|Outcome|Sugar Pill|Placebo: Placebo to match active drug Aripiprazole for 8 days
282888|NCT01292057|O1|Outcome|Aripiprazole|"Medication~Aripiprazole: Aripiprazole(up to 15 mg/day) for 8 days"
282889|NCT01292057|E2|Reported Event|Sugar Pill|Placebo: Placebo to match active drug Aripiprazole for 8 days
282890|NCT01292057|E1|Reported Event|Aripiprazole|"Medication~Aripiprazole: Aripiprazole(up to 15 mg/day) for 8 days"
282891|NCT01292005|B3|Baseline|Total|Total of all reporting groups
282892|NCT01292005|B2|Baseline|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
282893|NCT01292005|B1|Baseline|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
282894|NCT01292005|P2|Participant Flow|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
282895|NCT01292005|P1|Participant Flow|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
282896|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
282897|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
282898|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
282899|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
282900|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
282901|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
282902|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
282903|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
282904|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
282905|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
282906|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
282907|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
282908|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
282909|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
282910|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
282911|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
282912|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
282913|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
282914|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
282915|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
282916|NCT01292005|E2|Reported Event|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
282917|NCT01292005|E1|Reported Event|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
282918|NCT01291836|B1|Baseline|Enrollment Group-No Treatment Arms.|All subjects underwent the same protocol procedures no stratification.
282919|NCT01291836|P2|Participant Flow|Subjects Enrolled But Not Included in the Analysis.|Subjects that were consented and some study procedures completed but did not have required study procedures completed and subsequent data available for inclusion in the primary analysis.
282920|NCT01291836|P1|Participant Flow|Enrollment Group|Subjects with sufficient data to be included in the analysis.
282921|NCT01291836|O1|Outcome|Enrollment Group|Subjects enrolled and completing the required study procedures for the primary analysis.
282922|NCT01291836|O1|Outcome|Enrollment Group|Subjects enrolled in the study and completing required procedures to be included in the primary analysis.
282923|NCT01291836|E2|Reported Event|Non-participating Group|Subjects consented and/or enrolled in the study but not completing study procedures required for the analysis.
282924|NCT01291836|E1|Reported Event|Enrollment Group|Subjects enrolled in the study and completing study procedures required for the analysis.
282925|NCT01291784|B1|Baseline|Phase 1 MF Subjects|3 subjects were enrolled in the study. The three subjects were treated at a GC1008 dose level of 1 mg/kg given intravenously over approximately 60 minutes and then repeated every 28 days for a total of 6 cycles in the core study period and then an additional 6 cycles in an extension phase.
282926|NCT01291784|P3|Participant Flow|Sub C|Subject C
282927|NCT01291784|P2|Participant Flow|Sub B|Subject B
282928|NCT01291784|P1|Participant Flow|Sub A|Subject A
282929|NCT01291784|O3|Outcome|Sub C|Subject C
282930|NCT01291784|O2|Outcome|Sub B|Subject B
282931|NCT01291784|O1|Outcome|Sub A|Subject A
282932|NCT01291784|O3|Outcome|Sub C|Subject C
282933|NCT01291784|O2|Outcome|Sub B|Subject B
282934|NCT01291784|O1|Outcome|Sub A|Subject A
282935|NCT01291784|O3|Outcome|Sub C|Subject C
282936|NCT01291784|O2|Outcome|Sub B|Subject B
282937|NCT01291784|O1|Outcome|Sub A|Subject A
282938|NCT01291784|O3|Outcome|Sub C|Subject C
282939|NCT01291784|O2|Outcome|Sub B|Subject B
282940|NCT01291784|O1|Outcome|Sub A|Subject A
282941|NCT01291784|O3|Outcome|Sub C|Subject C
282942|NCT01291784|O2|Outcome|Sub B|Subject B
282943|NCT01291784|O1|Outcome|Sub A|Subject A
282944|NCT01291784|E3|Reported Event|Sub C|Subject C
282945|NCT01291784|E2|Reported Event|Sub B|Subject B
282946|NCT01291784|E1|Reported Event|Sub A|Subject A
282947|NCT01291498|B1|Baseline|HIFU Treatment|This is a single arm study, all subjects are planned to received HIFU treatment
282948|NCT01291498|P1|Participant Flow|HIFU Treatment|This is a single arm study, all subjects are planned to receive HIFU treatment
282949|NCT01291498|O1|Outcome|HIFU Treatment|Allsubjects are planned to have HIFU Treatment
282950|NCT01291498|O1|Outcome|HIFU Treatment|Ablation of the parathyroid gland by HIFU Treatment
282951|NCT01291498|O1|Outcome|HIFU Treatment|This is a single arm study, all subjects are planned to receive HIFU treatment
326779|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
282952|NCT01291498|E1|Reported Event|HIFU Treatment|This is a single arm study, all subjects are planned to received HIFU treatment
282953|NCT01291277|B3|Baseline|Total|Total of all reporting groups
282954|NCT01291277|B2|Baseline|Ligation 2-week Interval|"Endoscopic variceal ligation performed at 2-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
282955|NCT01291277|B1|Baseline|Ligation: 1-week Interval|"Endoscopic variceal ligation performed at 1-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
282956|NCT01291277|P2|Participant Flow|Ligation 2-week Interval|"Endoscopic variceal ligation performed at 2-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
282957|NCT01291277|P1|Participant Flow|Ligation: 1-week Interval|"Endoscopic variceal ligation performed at 1-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
282958|NCT01291277|O2|Outcome|Ligation 2-week Interval|"Endoscopic variceal ligation performed at 2-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
282959|NCT01291277|O1|Outcome|Ligation: 1-week Interval|"Endoscopic variceal ligation performed at 1-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
282960|NCT01291277|E2|Reported Event|Ligation 2-week Interval|"Endoscopic variceal ligation performed at 2-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
282961|NCT01291277|E1|Reported Event|Ligation: 1-week Interval|"Endoscopic variceal ligation performed at 1-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
282962|NCT01291264|B1|Baseline|Men Who Have Sex With Men|The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs.
282963|NCT01291264|P1|Participant Flow|Men Who Have Sex With Men|The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs.
282964|NCT01291264|O1|Outcome|Men Who Have Sex With Men|The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs.
282965|NCT01291264|E1|Reported Event|Men Who Have Sex With Men|The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs.
282966|NCT01291225|B3|Baseline|Total|Total of all reporting groups
282967|NCT01291225|B2|Baseline|Farms|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
282968|NCT01291225|B1|Baseline|Playground|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
282969|NCT01291225|P2|Participant Flow|Farms|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
282970|NCT01291225|P1|Participant Flow|Playground|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
282971|NCT01291225|O4|Outcome|Farms--Pickaway/Morrow Counties|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
282972|NCT01291225|O3|Outcome|Farms--Ross County|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
282973|NCT01291225|O2|Outcome|Playground--Circleville|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
282974|NCT01291225|O1|Outcome|Playground--Chillicothe|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
282975|NCT01291225|O2|Outcome|Farms|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
282976|NCT01291225|O1|Outcome|Playground|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
282977|NCT01291225|E2|Reported Event|Farms|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
282978|NCT01291225|E1|Reported Event|Playground|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
282979|NCT01291173|B5|Baseline|Total|Total of all reporting groups
282980|NCT01291173|B4|Baseline|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
282981|NCT01291173|B3|Baseline|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
282982|NCT01291173|B2|Baseline|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
282983|NCT01291173|B1|Baseline|Placebo|Placebo capsule taken once daily for up to 11 weeks
282984|NCT01291173|P4|Participant Flow|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
282985|NCT01291173|P3|Participant Flow|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
282986|NCT01291173|P2|Participant Flow|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
282987|NCT01291173|P1|Participant Flow|Placebo|Placebo capsule taken once daily for up to 11 weeks
282988|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
282989|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
282990|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
282991|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
282992|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
282993|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
282994|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
282995|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
285985|NCT01284959|B1|Baseline|Risperidone|Drug: risperidone Groups: risperidone
282996|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
282997|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
282998|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
282999|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
283000|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
283001|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
283002|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
283003|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
283004|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
283005|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
283006|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
283007|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
283008|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
283009|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
283010|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
283011|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
283012|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
283013|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
283014|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
283015|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
283016|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
283017|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
283018|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
283019|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
283020|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
283021|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
283022|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
283023|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
283024|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
283025|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
283026|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
283027|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
283028|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
283029|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
283030|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
283031|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
283032|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
283033|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
283034|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
283035|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
283036|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
283037|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
283038|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
283039|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
283040|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
283041|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
283042|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
283043|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
283044|NCT01291173|E4|Reported Event|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
283045|NCT01291173|E3|Reported Event|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
283046|NCT01291173|E2|Reported Event|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
283047|NCT01291173|E1|Reported Event|Placebo|Placebo capsule taken once daily for up to 11 weeks
283048|NCT01291160|B3|Baseline|Total|Total of all reporting groups
283065|NCT01291108|P3|Participant Flow|AGN-210669 + Bimatoprost Vehicle|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
283430|NCT01290315|O3|Outcome|Ferric Carboxymaltose (FCM) Cohort II|"Intravenous iron~Ferric Carboxymaltose (FCM): One 750 mg dose at 100 mg/minute (Cohort II)"
283049|NCT01291160|B2|Baseline|Sham Device|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.~Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
283050|NCT01291160|B1|Baseline|Epiflo Treatment|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.~Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
283051|NCT01291160|P2|Participant Flow|Sham Device|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.~Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
283052|NCT01291160|P1|Participant Flow|Epiflo Treatment|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.~Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
283053|NCT01291160|O2|Outcome|Sham Device|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.~Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
283054|NCT01291160|O1|Outcome|Epiflo Treatment|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.~Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
283055|NCT01291160|E2|Reported Event|Sham Device|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.~Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
283056|NCT01291160|E1|Reported Event|Epiflo Treatment|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.~Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
283057|NCT01291108|B5|Baseline|Total|Total of all reporting groups
283058|NCT01291108|B4|Baseline|Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle|bimatoprost 0.03% applied as 1 drop in each eye every evening for Month 1 followed by bimatoprost 0.03% + bimatoprost 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening for Month 2.
283059|NCT01291108|B3|Baseline|Bimatoprost Followed by Bimatoprost + AGN-210669|bimatoprost 0.03% applied as 1 drop in each eye every evening for Month 1 followed by bimatoprost 0.03% + AGN-210669 applied as 1 drop of each treatment in both eyes every evening for Month 2.
283060|NCT01291108|B2|Baseline|AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle|AGN-210669 0.05% applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening for Month 2.
283061|NCT01291108|B1|Baseline|AGN-210669 Followed by AGN-210669 + Bimatoprost|AGN-210669 0.05% applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% applied as 1 drop of each treatment in both eyes every evening for Month 2.
283062|NCT01291108|P6|Participant Flow|Bimatoprost + Bimatoprost Vehicle|bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
283063|NCT01291108|P5|Participant Flow|Bimatoprost + AGN-210669|bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2.
283064|NCT01291108|P4|Participant Flow|Bimatoprost|bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1.
283066|NCT01291108|P2|Participant Flow|AGN-210669 + Bimatoprost|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2.
283067|NCT01291108|P1|Participant Flow|AGN-210669|AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1.
283068|NCT01291108|O3|Outcome|Combined Adjunctives|Combined adjunctives refer to the combined groups of ’AGN-210669 0.05% + bimatoprost’ and ’bimatoprost + AGN-210669 0.05%’. The first treatment is applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% applied as 1 drop of each treatment in both eyes every evening for Month 2.
283069|NCT01291108|O2|Outcome|Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle|bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
283070|NCT01291108|O1|Outcome|AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
283071|NCT01291108|O3|Outcome|Combined Adjunctives|Combined adjunctives refer to the combined groups of ’AGN-210669 0.05% + bimatoprost’ and ’bimatoprost + AGN-210669 0.05%’. The first treatment is applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% applied as 1 drop of each treatment in both eyes every evening for Month 2.
283072|NCT01291108|O2|Outcome|Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle|bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
283073|NCT01291108|O1|Outcome|AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
283074|NCT01291108|E6|Reported Event|Bimatoprost + Bimatoprost Vehicle|bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
283075|NCT01291108|E5|Reported Event|Bimatoprost + AGN-210669|bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2.
283076|NCT01291108|E4|Reported Event|Bimatoprost|bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1.
283077|NCT01291108|E3|Reported Event|AGN-210669 + Bimatoprost Vehicle|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
283078|NCT01291108|E2|Reported Event|AGN-210669 + Bimatoprost|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2.
283079|NCT01291108|E1|Reported Event|AGN-210669|AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1.
283080|NCT01291056|B3|Baseline|Total|Total of all reporting groups
283081|NCT01291056|B2|Baseline|Placebo, Then Clomiphene Citrate|Placebo, then Clomiphene Citrate 50 milligrams daily
283082|NCT01291056|B1|Baseline|Clomiphene Citrate, Then Placebo|Clomiphene Citrate 50 milligrams daily, then Placebo daily
283083|NCT01291056|P2|Participant Flow|Placebo, Then Clomiphene Citrate|Placebo, then Clomiphene Citrate 50 milligrams daily
283084|NCT01291056|P1|Participant Flow|Clomiphene Citrate, Then Placebo|Clomiphene Citrate 50 milligrams daily, then Placebo daily
283085|NCT01291056|O2|Outcome|Placebo|Placebo
283086|NCT01291056|O1|Outcome|Clomiphene Citrate|Clomiphene Citrate 50 milligrams daily
283087|NCT01291056|O2|Outcome|Placebo|Placebo
283088|NCT01291056|O1|Outcome|Clomiphene Citrate|Clomiphene Citrate 50 milligrams daily
283089|NCT01291056|O2|Outcome|Placebo|Placebo
283090|NCT01291056|O1|Outcome|Clomiphene Citrate|Clomiphene Citrate 50 milligrams daily
283091|NCT01291056|O2|Outcome|Placebo|Placebo
283092|NCT01291056|O1|Outcome|Clomiphene Citrate|Clomiphene Citrate 50 milligrams daily
283093|NCT01291056|E2|Reported Event|Placebo, Then Clomiphene Citrate|Placebo daily, then Clomiphene Citrate 50 milligrams daily
283094|NCT01291056|E1|Reported Event|Clomiphene Citrate, Then Placebo|Clomiphene Citrate 50 milligrams daily, then Placebo daily
283095|NCT01291017|B1|Baseline|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
283096|NCT01291017|P1|Participant Flow|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
283097|NCT01291017|O1|Outcome|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
283098|NCT01291017|O1|Outcome|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
283099|NCT01291017|O1|Outcome|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
283100|NCT01291017|O1|Outcome|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
283101|NCT01291017|O1|Outcome|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
283102|NCT01291017|E1|Reported Event|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
283103|NCT01290978|B1|Baseline|ChloraPrep , DuraPrep|Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.
283104|NCT01290978|P1|Participant Flow|ChloraPrep, DuraPrep|Subject's back was visually divide into 2. Applied each prep per manufacturer's instruction on either right or left of back according to randomization schedule
283105|NCT01290978|O2|Outcome|DuraPrep|Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.
283106|NCT01290978|O1|Outcome|ChloraPrep|Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.
283107|NCT01290978|O2|Outcome|DuraPrep|Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.
283108|NCT01290978|O1|Outcome|ChloraPrep|Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.
283109|NCT01290978|E1|Reported Event|ChloraPrep, DuraPrep|Subject's back was visually divide into 2. Applied each prep per manufacturer's instruction on either right or left of back according to randomization schedule
283111|NCT01290952|B2|Baseline|On-pump|"coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)~On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body."
283112|NCT01290952|B1|Baseline|Off Pump|"Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner~Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally."
283113|NCT01290952|P2|Participant Flow|On-pump|"coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)~On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body."
283114|NCT01290952|P1|Participant Flow|Off Pump|"Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner~Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally."
283115|NCT01290952|O2|Outcome|Off-pump Bypass Surgery|"Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner~Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally."
283116|NCT01290952|O1|Outcome|On-pump Bypass Surgery|"coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)~On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body."
283117|NCT01290952|O2|Outcome|On-pump|"coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)~On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body."
283118|NCT01290952|O1|Outcome|Off Pump|"Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner~Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally."
283119|NCT01290952|E2|Reported Event|On-pump|"coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)~On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body."
283120|NCT01290952|E1|Reported Event|Off Pump|"Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner~Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally."
283121|NCT01290913|B1|Baseline|Omalizumab, Oral Desensitization|Omalizumab treatment and oral peanut desensitization
283122|NCT01290913|P1|Participant Flow|Omalizumab, Oral Desensitization|Omalizumab treatment and oral peanut desensitization
283123|NCT01290913|O1|Outcome|Omalizumab, Oral Desensitization|Omalizumab treatment and oral peanut desensitization
283124|NCT01290913|O1|Outcome|Omalizumab, Oral Desensitization|Omalizumab treatment and oral peanut desensitization
283125|NCT01290913|E1|Reported Event|Omalizumab, Oral Desensitization|Omalizumab treatment and oral peanut desensitization
283126|NCT01290887|B3|Baseline|Total|Total of all reporting groups
283127|NCT01290887|B2|Baseline|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283128|NCT01290887|B1|Baseline|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283129|NCT01290887|P2|Participant Flow|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283130|NCT01290887|P1|Participant Flow|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283131|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283132|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283133|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
283134|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283135|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283136|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
283137|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283138|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283139|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
283140|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283141|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283142|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
283143|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283144|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283145|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
283146|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283147|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283148|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
283149|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283150|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283151|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
283152|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283153|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283154|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
283155|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283156|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283157|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
283158|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283159|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283160|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
283161|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283162|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283163|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
283164|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
285986|NCT01284959|P3|Participant Flow|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
283165|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
283166|NCT01290887|E1|Reported Event|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
283167|NCT01290874|B3|Baseline|Total|Total of all reporting groups
283168|NCT01290874|B2|Baseline|Salmeterol or Formoterol|"Long acting beta agonists (Serevent, Foradil) are the standard treatments for moderate asthma. The efficacy of Tiotropium will be compared to this standard.~Salmeterol: Salmeterol 50 mcg twice daily for one year of treatment.~Formoterol: Formoterol 12 mcg twice daily for one year"
283169|NCT01290874|B1|Baseline|Tiotropium|"Tiotropium bromide will be evaluated as a treatment for asthma.~Tiotropium: Tiotropium bromide 18 mcg once daily for one year of treatment."
283170|NCT01290874|P2|Participant Flow|Salmeterol or Formoterol|"Long acting beta agonists (Serevent, Foradil) are the standard treatments for moderate asthma. The efficacy of Tiotropium will be compared to this standard.~Salmeterol: Salmeterol 50 mcg twice daily for one year of treatment.~Formoterol: Formoterol 12 mcg twice daily for one year"
283171|NCT01290874|P1|Participant Flow|Tiotropium|Tiotropium: Tiotropium bromide 18 mcg once daily for one year of treatment.
283172|NCT01290874|O2|Outcome|Salmeterol or Formoterol|"Long acting beta agonists (Serevent, Foradil) are the standard treatments for moderate asthma. The efficacy of Tiotropium will be compared to this standard.~Salmeterol: Salmeterol 50 mcg twice daily for one year of treatment.~Formoterol: Formoterol 12 mcg twice daily for one year"
283173|NCT01290874|O1|Outcome|Tiotropium|"Tiotropium bromide will be evaluated as a treatment for asthma.~Tiotropium: Tiotropium bromide 18 mcg once daily for one year of treatment."
283174|NCT01290874|O2|Outcome|Salmeterol or Formoterol|"Long acting beta agonists (Serevent, Foradil) are the standard treatments for moderate asthma. The efficacy of Tiotropium will be compared to this standard.~Salmeterol: Salmeterol 50 mcg twice daily for one year of treatment.~Formoterol: Formoterol 12 mcg twice daily for one year"
283175|NCT01290874|O1|Outcome|Tiotropium|Tiotropium: Tiotropium bromide 18 mcg once daily for one year of treatment.
283176|NCT01290874|O2|Outcome|Salmeterol or Formoterol|"Long acting beta agonists (Serevent, Foradil) are the standard treatments for moderate asthma. The efficacy of Tiotropium will be compared to this standard.~Salmeterol: Salmeterol 50 mcg twice daily for one year of treatment.~Formoterol: Formoterol 12 mcg twice daily for one year"
283177|NCT01290874|O1|Outcome|Tiotropium|"Tiotropium bromide will be evaluated as a treatment for asthma.~Tiotropium: Tiotropium bromide 18 mcg once daily for one year of treatment."
283178|NCT01290874|O2|Outcome|Salmeterol or Formoterol|"Long acting beta agonists (Serevent, Foradil) are the standard treatments for moderate asthma. The efficacy of Tiotropium will be compared to this standard.~Salmeterol: Salmeterol 50 mcg twice daily for one year of treatment.~Formoterol: Formoterol 12 mcg twice daily for one year"
283179|NCT01290874|O1|Outcome|Tiotropium|"Tiotropium bromide will be evaluated as a treatment for asthma.~Tiotropium: Tiotropium bromide 18 mcg once daily for one year of treatment."
283180|NCT01290874|O2|Outcome|Salmeterol or Formoterol|"Long acting beta agonists (Serevent, Foradil) are the standard treatments for moderate asthma. The efficacy of Tiotropium will be compared to this standard.~Salmeterol: Salmeterol 50 mcg twice daily for one year of treatment.~Formoterol: Formoterol 12 mcg twice daily for one year"
283181|NCT01290874|O1|Outcome|Tiotropium|Tiotropium: Tiotropium bromide 18 mcg once daily for one year of treatment.
283182|NCT01290874|O2|Outcome|Salmeterol or Formoterol|"Long acting beta agonists (Serevent, Foradil) are the standard treatments for moderate asthma. The efficacy of Tiotropium will be compared to this standard.~Salmeterol: Salmeterol 50 mcg twice daily for one year of treatment.~Formoterol: Formoterol 12 mcg twice daily for one year"
283183|NCT01290874|O1|Outcome|Tiotropium|Tiotropium: Tiotropium bromide 18 mcg once daily for one year of treatment.
283184|NCT01290874|O2|Outcome|Salmeterol or Formoterol|"Long acting beta agonists (Serevent, Foradil) are the standard treatments for moderate asthma. The efficacy of Tiotropium will be compared to this standard.~Salmeterol: Salmeterol 50 mcg twice daily for one year of treatment.~Formoterol: Formoterol 12 mcg twice daily for one year"
283185|NCT01290874|O1|Outcome|Tiotropium|Tiotropium: Tiotropium bromide 18 mcg once daily for one year of treatment.
283186|NCT01290874|O2|Outcome|Salmeterol or Formoterol|"Long acting beta agonists (Serevent, Foradil) are the standard treatments for moderate asthma. The efficacy of Tiotropium will be compared to this standard.~Salmeterol: Salmeterol 50 mcg twice daily for one year of treatment.~Formoterol: Formoterol 12 mcg twice daily for one year"
283187|NCT01290874|O1|Outcome|Tiotropium|Tiotropium: Tiotropium bromide 18 mcg once daily for one year of treatment.
283188|NCT01290874|E2|Reported Event|Salmeterol or Formoterol|"Long acting beta agonists (Serevent, Foradil) are the standard treatments for moderate asthma. The efficacy of Tiotropium will be compared to this standard.~Salmeterol: Salmeterol 50 mcg twice daily for one year of treatment.~Formoterol: Formoterol 12 mcg twice daily for one year"
283189|NCT01290874|E1|Reported Event|Tiotropium|Tiotropium: Tiotropium bromide 18 mcg once daily for one year of treatment.
283190|NCT01290822|B1|Baseline|All Subjects in the Study|"This includes all subjects in the study. Per Arm information is not available for the 1 subject who completed the study. It is also not available for the rest of the subjects as they were withdrawn before being studied."
283191|NCT01290822|P1|Participant Flow|All Subjects in the Study|"This includes all subjects in the study. Per Arm information is not available for the 1 subject who completed the study. It is also not available for the rest of the subjects as they were withdrawn before being studied."
283192|NCT01290822|O1|Outcome|All Subjects in the Study|This includes all subjects in the study
283193|NCT01290822|O1|Outcome|All Subjects in the Study|This includes all subjects in the study
283194|NCT01290822|O1|Outcome|All Subjects in the Study|This includes all subjects in the study
283195|NCT01290822|O1|Outcome|All Subjects in the Study|This includes all subjects in the study
283196|NCT01290822|O1|Outcome|All Subjects in the Study|This includes all subjects in the study
283197|NCT01290822|O1|Outcome|All Subjects in the Study|This includes all subjects in the study
283198|NCT01290822|E1|Reported Event|All Subjects in the Study|This includes all subjects in the study
283199|NCT01290796|B1|Baseline|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
283200|NCT01290796|P1|Participant Flow|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
283201|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
283202|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
283203|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
283204|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
283205|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
283206|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
283207|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
283208|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
283209|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
283210|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
283211|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
283259|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283212|NCT01290796|E1|Reported Event|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
283213|NCT01290757|B3|Baseline|Total|Total of all reporting groups
283214|NCT01290757|B2|Baseline|Sequence: Capsugel - Qualicaps - Capsugel - Qualicaps|Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps (TRTR)
283215|NCT01290757|B1|Baseline|Sequence: Qualicaps - Capsugel - Qualicaps - Capsugel|Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel (RTRT)
283216|NCT01290757|P2|Participant Flow|Sequence: Capsugel - Qualicaps - Capsugel - Qualicaps|Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps (TRTR)
283217|NCT01290757|P1|Participant Flow|Sequence: Qualicaps - Capsugel - Qualicaps - Capsugel|Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel (RTRT)
283218|NCT01290757|O2|Outcome|Qualicaps|Dabigatran 150mg in currently approved Qualicaps
283219|NCT01290757|O1|Outcome|Capsugel|Dabigatran 150mg in new Capsugel
283220|NCT01290757|O2|Outcome|Qualicaps|Dabigatran 150mg in currently approved Qualicaps
283221|NCT01290757|O1|Outcome|Capsugel|Dabigatran 150mg in new Capsugel
283222|NCT01290757|O2|Outcome|Qualicaps|Dabigatran 150mg in currently approved Qualicaps
283223|NCT01290757|O1|Outcome|Capsugel|Dabigatran 150mg in new Capsugel
283224|NCT01290757|O2|Outcome|Qualicaps|Dabigatran 150mg in currently approved Qualicaps
283225|NCT01290757|O1|Outcome|Capsugel|Dabigatran 150mg in new Capsugel
283226|NCT01290757|O2|Outcome|Qualicaps|Dabigatran 150mg in currently approved Qualicaps
283227|NCT01290757|O1|Outcome|Capsugel|Dabigatran 150mg in new Capsugel
283228|NCT01290757|O2|Outcome|Qualicaps|Dabigatran 150mg in currently approved Qualicaps
283229|NCT01290757|O1|Outcome|Capsugel|Dabigatran 150mg in new Capsugel
283230|NCT01290757|E2|Reported Event|Capsugel|Dabigatran 150mg in Capsugel
283231|NCT01290757|E1|Reported Event|Qualicaps|Dabigatran 150mg in Qualicaps
283232|NCT01290731|B1|Baseline|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
283233|NCT01290731|P1|Participant Flow|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
283234|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
283235|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
283236|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
283237|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
283238|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
283239|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
283260|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
285987|NCT01284959|P2|Participant Flow|Placebo|drug: lactose group: placebo
283240|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
283241|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
283242|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
283243|NCT01290731|E1|Reported Event|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
283244|NCT01290718|B1|Baseline|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
283245|NCT01290718|P1|Participant Flow|Capecitabine Plus (+) Trastuzumab|Participants received capecitabine 900 milligrams per square meter (mg/m^2) orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 milligrams per kilogram (mg/kg) intravenously (iv) on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
283246|NCT01290718|O1|Outcome|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
283247|NCT01290718|O1|Outcome|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
283248|NCT01290718|O1|Outcome|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
283249|NCT01290718|O1|Outcome|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
283250|NCT01290718|E1|Reported Event|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
283251|NCT01290679|B3|Baseline|Total|Total of all reporting groups
283252|NCT01290679|B2|Baseline|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283253|NCT01290679|B1|Baseline|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283254|NCT01290679|P2|Participant Flow|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283255|NCT01290679|P1|Participant Flow|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283256|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283257|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283258|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283364|NCT01290614|B2|Baseline|Control - Usual Care|"Patients assigned to control will continue to receive care from their VA provider.~Usual Care: Patients in the control arm will continue to receive usual care from their VA providers."
283891|NCT01289574|B3|Baseline|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
283261|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283262|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283263|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283264|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283265|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283266|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283267|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283268|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283269|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283270|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283271|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283272|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283273|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283274|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283275|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283276|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283277|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283278|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283279|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283426|NCT01290315|P3|Participant Flow|Ferric Carboxymaltose (FCM) Cohort II|"Intravenous iron~Ferric Carboxymaltose (FCM): One 750 mg dose at 100 mg/minute (Cohort II)"
283280|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283281|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283282|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283283|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283284|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283285|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283286|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283287|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283288|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283289|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283290|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283291|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283292|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283293|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283294|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283295|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283296|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283297|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283298|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283299|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283892|NCT01289574|B2|Baseline|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
283300|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283301|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283302|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283303|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283304|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283305|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283306|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283307|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283308|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283309|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283310|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283311|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283312|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283313|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283314|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283315|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283316|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283317|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283318|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283319|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283893|NCT01289574|B1|Baseline|Vehicle Control Cream|ASC-J9: Cream for twice daily topical application to the face
283320|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283321|NCT01290679|E2|Reported Event|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
283322|NCT01290679|E1|Reported Event|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283323|NCT01290666|B1|Baseline|GORE® BIO-A® Fistula Plug|"All patients in study receive the GORE® BIO-A® Fistula Plug.~Fistula Plug: Bioabsorbable fistula plug"
283324|NCT01290666|P1|Participant Flow|GORE® BIO-A® Fistula Plug|"All patients in study receive the GORE® BIO-A® Fistula Plug.~Fistula Plug: Bioabsorbable fistula plug"
283325|NCT01290666|O1|Outcome|GORE® BIO-A® Fistula Plug|"All patients in study receive the GORE® BIO-A® Fistula Plug.~Fistula Plug: Bioabsorbable fistula plug"
283326|NCT01290666|E1|Reported Event|GORE® BIO-A® Fistula Plug|"All patients in study receive the GORE® BIO-A® Fistula Plug.~Fistula Plug: Bioabsorbable fistula plug"
283327|NCT01290640|B3|Baseline|Total|Total of all reporting groups
283328|NCT01290640|B2|Baseline|Subjects Implanted With a DePuy Fixed-bearing Total Condylar I|
283329|NCT01290640|B1|Baseline|PFC RP TC3 TKA|
283330|NCT01290640|P2|Participant Flow|Subjects Implanted With a DePuy PFC Rotating Platform TC3 TKA|
283331|NCT01290640|P1|Participant Flow|Subjects Implanted With a DePuy Fixed-bearing Total Condylar I|Subjects implanted with a DePuy fixed-bearing Total Condylar III (TC3) TKA
283332|NCT01290640|O2|Outcome|Subjects With DePuy PFC Fixed Bearing TC3 TKA|
283333|NCT01290640|O1|Outcome|Subjects With DePuy PFC Rotating Platform TC3 TKA|
283334|NCT01290640|O2|Outcome|Subjects With DePuy PFC Fixed Bearing TC3 TKA|
283335|NCT01290640|O1|Outcome|Subjects With DePuy PFC Rotating Platform TC3 TKA|
283336|NCT01290640|E2|Reported Event|Subjects Implanted With a DePuy Fixed-bearing Total Condylar I|
283337|NCT01290640|E1|Reported Event|Subjects Implanted With a DePuy PFC Rotating Platform TC3 TKA|
283338|NCT01290627|B4|Baseline|Total|Total of all reporting groups
283339|NCT01290627|B3|Baseline|Control|Subjects with normal knees
283340|NCT01290627|B2|Baseline|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
283341|NCT01290627|B1|Baseline|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
283342|NCT01290627|P3|Participant Flow|Control|Subjects with normal knees
283343|NCT01290627|P2|Participant Flow|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
283344|NCT01290627|P1|Participant Flow|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
283345|NCT01290627|O3|Outcome|Control|Subjects with normal knees
283346|NCT01290627|O2|Outcome|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
283347|NCT01290627|O1|Outcome|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
283348|NCT01290627|O3|Outcome|Control|Subjects with normal knees
283349|NCT01290627|O2|Outcome|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
283350|NCT01290627|O1|Outcome|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
283351|NCT01290627|O3|Outcome|Control|Subjects with normal knees
283352|NCT01290627|O2|Outcome|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
283353|NCT01290627|O1|Outcome|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
283354|NCT01290627|O3|Outcome|Control|Subjects with normal knees
283355|NCT01290627|O2|Outcome|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
283356|NCT01290627|O1|Outcome|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
283357|NCT01290627|O3|Outcome|Control|Subjects with normal knees
283358|NCT01290627|O2|Outcome|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
283359|NCT01290627|O1|Outcome|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
283360|NCT01290627|E3|Reported Event|Control|Subjects with normal knees
283361|NCT01290627|E2|Reported Event|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
283362|NCT01290627|E1|Reported Event|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
283363|NCT01290614|B3|Baseline|Total|Total of all reporting groups
283427|NCT01290315|P2|Participant Flow|Iron Sucrose Cohort I|"Intravenous iron~Iron Sucrose: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I)"
283365|NCT01290614|B1|Baseline|Pharmacist Intervention|Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
283366|NCT01290614|P2|Participant Flow|Control - Usual Care|"Patients assigned to control will continue to receive care from their VA provider.~Usual Care: Patients in the control arm will continue to receive usual care from their VA providers."
283367|NCT01290614|P1|Participant Flow|Pharmacist Intervention|Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
283368|NCT01290614|O2|Outcome|Control - Usual Care|"Patients assigned to control will continue to receive care from their VA provider.~Usual Care: Patients in the control arm will continue to receive usual care from their VA providers."
283369|NCT01290614|O1|Outcome|Pharmacist Intervention|Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
283370|NCT01290614|O2|Outcome|Control - Usual Care|"Patients assigned to control will continue to receive care from their VA provider.~Usual Care: Patients in the control arm will continue to receive usual care from their VA providers."
283371|NCT01290614|O1|Outcome|Pharmacist Intervention|Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
283372|NCT01290614|E2|Reported Event|Control - Usual Care|"Patients assigned to control will continue to receive care from their VA provider.~Usual Care: Patients in the control arm will continue to receive usual care from their VA providers."
283373|NCT01290614|E1|Reported Event|Pharmacist Intervention|Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
283374|NCT01290601|B3|Baseline|Total|Total of all reporting groups
283375|NCT01290601|B2|Baseline|Cohort 1-Chloroquine|"Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.~Chloroquine + Primaquine: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days."
283376|NCT01290601|B1|Baseline|Cohort 1 Tafenoquine|"Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.~Tafenoquine: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days."
283377|NCT01290601|P4|Participant Flow|Cohort 2 Chloroquine|"Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 1 day, followed by chloroquine (1000 mg chloroquine phosphate) x 1 day, followed by chloroquine (500 mg chloroquine phosphate) x 1day, followed by primaquine, 15 mg/day for 14 days.~Chloroquine + Primaquine: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 1 day, followed by chloroquine (1000 mg chloroquine phosphate) x 1 day, followed by chloroquine (500 mg chloroquine phosphate) x 1day, followed by primaquine, 15 mg/day for 14 days."
283428|NCT01290315|P1|Participant Flow|Ferric Carboxymaltose (FCM) Cohort I|"Intravenous iron~Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I)"
285988|NCT01284959|P1|Participant Flow|Risperidone|Drug: risperidone Groups: risperidone
283378|NCT01290601|P3|Participant Flow|Cohort 2 Tafenoquine|"Tafenoquine (600 mg base) and chloroquine placebo x 1d, chloroquine placebo x 2 days, followed by primaquine placebo for 14 days.~tafenoquine: Tafenoquine (600 mg base) and chloroquine placebo x 1d, chloroquine placebo x 2 days, followed by primaquine placebo for 14 days."
283379|NCT01290601|P2|Participant Flow|Cohort 1-Chloroquine|"Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.~Chloroquine + Primaquine: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days."
283380|NCT01290601|P1|Participant Flow|Cohort 1 Tafenoquine|"Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.~Tafenoquine: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days."
283381|NCT01290601|O2|Outcome|Cohort 1-Chloroquine|"Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.~Chloroquine + Primaquine: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days."
283382|NCT01290601|O1|Outcome|Cohort 1 Tafenoquine|"Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.~Tafenoquine: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days."
283383|NCT01290601|O2|Outcome|Cohort 1-Chloroquine|"Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.~Chloroquine + Primaquine: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days."
283384|NCT01290601|O1|Outcome|Cohort 1 Tafenoquine|"Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.~Tafenoquine: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days."
283385|NCT01290601|O2|Outcome|Cohort 1-Chloroquine|"Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.~Chloroquine + Primaquine: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days."
283386|NCT01290601|O1|Outcome|Cohort 1 Tafenoquine|"Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.~Tafenoquine: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days."
283387|NCT01290601|O2|Outcome|Cohort 1-Chloroquine|"Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.~Chloroquine + Primaquine: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days."
283388|NCT01290601|O1|Outcome|Cohort 1 Tafenoquine|"Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.~Tafenoquine: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days."
283389|NCT01290601|O2|Outcome|Cohort 1-Chloroquine|"Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.~Chloroquine + Primaquine: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days."
283390|NCT01290601|O1|Outcome|Cohort 1 Tafenoquine|"Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.~Tafenoquine: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days."
283391|NCT01290601|E2|Reported Event|Cohort 1-Chloroquine|"Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.~Chloroquine + Primaquine: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days."
283429|NCT01290315|O4|Outcome|Iron Dextran Cohort II|"Intravenous iron~Iron Dextran: One 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)"
283392|NCT01290601|E1|Reported Event|Cohort 1 Tafenoquine|"Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.~Tafenoquine: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days."
283393|NCT01290536|B1|Baseline|Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
283394|NCT01290536|P1|Participant Flow|Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
283395|NCT01290536|O3|Outcome|Other Tumors - Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
283396|NCT01290536|O2|Outcome|Neuroendocrine - Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
283397|NCT01290536|O1|Outcome|Colorectal - Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
283398|NCT01290536|O1|Outcome|Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
283399|NCT01290536|E1|Reported Event|Yttrium-90 Liver Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
283400|NCT01290523|B1|Baseline|Yttrium-90 Liver Radioembolization|"Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)~Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery"
283401|NCT01290523|P1|Participant Flow|Yttrium-90 Liver Radioembolization|"Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)~Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery"
283402|NCT01290523|O1|Outcome|Yttrium-90 Liver Radioembolization|"Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)~Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery"
283403|NCT01290523|O1|Outcome|Yttrium-90 Liver Radioembolization|"Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)~Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery"
283404|NCT01290523|E1|Reported Event|Yttrium-90 Liver Radioembolization|"Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)~Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery"
283405|NCT01290484|B1|Baseline|Sildenafil|Male and female subjects between the ages of 6 months and 10 years, weighing at least 8 kg and had been given a diagnosis of a lymphatic malformation of at least 3 cm based on clinical and radiologic criteria. Macrocystic, microcystic, or mixed lymphatic malformations involving any location on the body were included. Lymphatic malformations associated with an incomplete response to previous treatments, a risk of functional or aesthetic impairment, or local complications were included.
283406|NCT01290484|P1|Participant Flow|Sildenafil|Participants were given sildenafil for 20 weeks. Participants weighing more than 20 kg were given 20 mg 3 times daily (60 mg/day). Participants weighing between 8 kg and 20 kg were given 10 mg 3 times daily (30 mg/day).
283407|NCT01290484|O1|Outcome|Sildenafil|The primary outcome was the effect of sildenafil on lymphatic malformation volume. Response to sildenafil was characterized by any decrease in lymphatic malformation volume. Lymphatic malformations volumes were assessed blindly by MRI volume segmentation analysis at baseline and after 20 weeks of sildenafil. 4 subjects had a lymphatic malformation volume decrease.
283408|NCT01290484|E1|Reported Event|Sildenafil|Adverse events reported while one sildenafil were minimal. All subjects tolerated the prescribed medication dose. One subject developed an upper respiratory tract infection and experienced temporary hearing loss due to fluid accumulation. This was resolved completely and she experienced no further hearing loss while on sildenafil. Four parents requested to have the child continue sildenafil after study completion.
283409|NCT01290341|B3|Baseline|Total|Total of all reporting groups
283410|NCT01290341|B2|Baseline|Placebo|Topical; applied once daily for two weeks.
283411|NCT01290341|B1|Baseline|NAFT-600|Topical; applied once daily for two weeks
283412|NCT01290341|P2|Participant Flow|Placebo|Topical; applied once daily for two weeks.
283413|NCT01290341|P1|Participant Flow|NAFT-600|Topical; applied once daily for two weeks
283414|NCT01290341|O2|Outcome|Placebo|Topical; applied once daily for two weeks.
283415|NCT01290341|O1|Outcome|NAFT-600|Topical; applied once daily for two weeks
283416|NCT01290341|O2|Outcome|Placebo|Topical; applied once daily for two weeks.
283417|NCT01290341|O1|Outcome|NAFT-600|Topical; applied once daily for two weeks
283418|NCT01290341|E2|Reported Event|Placebo|Topical; applied once daily for two weeks.
283419|NCT01290341|E1|Reported Event|NAFT-600|Topical; applied once daily for two weeks
283420|NCT01290315|B5|Baseline|Total|Total of all reporting groups
283421|NCT01290315|B4|Baseline|Iron Dextran Cohort II|"Intravenous iron~Iron Dextran: One 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)"
283422|NCT01290315|B3|Baseline|Ferric Carboxymaltose (FCM) Cohort II|"Intravenous iron~Ferric Carboxymaltose (FCM): One 750 mg dose at 100 mg/minute (Cohort II)"
283423|NCT01290315|B2|Baseline|Iron Sucrose Cohort I|"Intravenous iron~Iron Sucrose: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I)"
283424|NCT01290315|B1|Baseline|Ferric Carboxymaltose (FCM) Cohort I|"Intravenous iron~Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I)"
283425|NCT01290315|P4|Participant Flow|Iron Dextran Cohort II|"Intravenous iron~Iron Dextran: One 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)"
283431|NCT01290315|O2|Outcome|Iron Sucrose Cohort I|"Intravenous iron~Iron Sucrose: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I)"
283432|NCT01290315|O1|Outcome|Ferric Carboxymaltose (FCM) Cohort I|"Intravenous iron~Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I)"
283433|NCT01290315|O4|Outcome|Iron Dextran Cohort II|"Intravenous iron~Iron Dextran: One 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)"
283434|NCT01290315|O3|Outcome|Ferric Carboxymaltose (FCM) Cohort II|"Intravenous iron~Ferric Carboxymaltose (FCM): One 750 mg dose at 100 mg/minute (Cohort II)"
283435|NCT01290315|O2|Outcome|Iron Sucrose Cohort I|"Intravenous iron~Iron Sucrose: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I)"
283436|NCT01290315|O1|Outcome|Ferric Carboxymaltose (FCM) Cohort I|"Intravenous iron~Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I)"
283437|NCT01290315|O4|Outcome|Iron Dextran Cohort II|"Intravenous iron~Iron Dextran: One 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)"
283438|NCT01290315|O3|Outcome|Ferric Carboxymaltose (FCM) Cohort II|"Intravenous iron~Ferric Carboxymaltose (FCM): One 750mg dose at 100 mg/minute (Cohort II)"
283439|NCT01290315|O2|Outcome|Iron Sucrose Cohort I|"Intravenous iron~Iron Sucrose: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I)"
283440|NCT01290315|O1|Outcome|Ferric Carboxymaltose (FCM) Cohort I|"Intravenous iron~Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I)"
283441|NCT01290315|O4|Outcome|Iron Dextran Cohort II|"Intravenous iron~Iron Dextran: One 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)"
283442|NCT01290315|O3|Outcome|Ferric Carboxymaltose (FCM) Cohort II|"Intravenous iron~Ferric Carboxymaltose (FCM): One 750 mg dose at 100 mg/minute (Cohort II)"
283443|NCT01290315|O2|Outcome|Iron Sucrose Cohort I|"Intravenous iron~Iron Sucrose: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I)"
283444|NCT01290315|O1|Outcome|Ferric Carboxymaltose (FCM) Cohort I|"Intravenous iron~Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I)"
283445|NCT01290315|E2|Reported Event|Iron Sucrose or Iron Dextran|"Intravenous iron~Iron Sucrose / Iron Dextran: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I), or a 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)"
283446|NCT01290315|E1|Reported Event|Ferric Carboxymaltose (FCM)|"Intravenous iron~Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I) or 750 mg dose at 100 mg/minute (Cohort II)"
283447|NCT01290263|B3|Baseline|Total|Total of all reporting groups
283448|NCT01290263|B2|Baseline|Cohort A: AMG 386 30 mg/kg|All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
283449|NCT01290263|B1|Baseline|Cohort B: AMG 386 + Bevacizumab|All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
283450|NCT01290263|P5|Participant Flow|All Cohort B Participants: AMG 386 + Bevacizumab|Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
283451|NCT01290263|P4|Participant Flow|Cohort B Phase II: AMG 386 30 mg/kg + Bevacizumab|Participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the maximum tolerated AMG 386 dose established in the Phase I Cohort B study, AMG 386 of 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
283452|NCT01290263|P3|Participant Flow|Cohort B Phase I Dose Level +1: AMG 386 30 mg/kg + Bevacizumab|"Cohort B Phase I Dose Level +1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.~As of June 2014, the maximum tolerated dose (MTD) of bevacizumab + AMG 386 was determined to be dose level +1, AMG 386 30 mg + kg."
283453|NCT01290263|P2|Participant Flow|Cohort B Phase I Dose Level 0: AMG 386 15 mg/kg + Bevacizumab|Cohort B Phase I Dose Level 0 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting dose AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
283454|NCT01290263|P1|Participant Flow|Cohort A: AMG 386 30 mg/kg|Cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
283455|NCT01290263|O2|Outcome|Cohort B Phase I Dose Level +1: AMG 386 30 mg/kg + Bevacizumab|"Cohort B Phase I Dose Level +1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.~As of June 2014, the maximum tolerated dose (MTD) of bevacizumab + AMG 386 was determined to be dose level +1, AMG 386 30 mg/kg."
283456|NCT01290263|O1|Outcome|Cohort B Phase I Dose Level 0: AMG 386 15 mg/kg + Bevacizumab|Cohort B Phase I Dose Level 0 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting dose AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
283457|NCT01290263|O2|Outcome|Cohort A: AMG 386 30 mg/kg|All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
283495|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
285989|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
283458|NCT01290263|O1|Outcome|All Cohort B Participants: AMG 386 + Bevacizumab|All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
283459|NCT01290263|O2|Outcome|Cohort A: AMG 386 30 mg/kg|All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
283460|NCT01290263|O1|Outcome|All Cohort B Participants: AMG 386 + Bevacizumab|All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
283461|NCT01290263|O2|Outcome|Cohort A: AMG 386 30 mg/kg|All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
283462|NCT01290263|O1|Outcome|All Cohort B Participants: AMG 386 + Bevacizumab|All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
283463|NCT01290263|O2|Outcome|Cohort B Phase I Dose Level +1: AMG 386 30 mg/kg + Bevacizumab|"Cohort B Phase I Dose Level +1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.~As of June 2014, the maximum tolerated dose (MTD) of bevacizumab + AMG 386 was determined to be dose level +1, AMG 386 30 mg/kg."
283464|NCT01290263|O1|Outcome|Cohort B Phase I Dose Level 0: AMG 386 15 mg/kg + Bevacizumab|Cohort B Phase I Dose Level 0 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting dose AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
283465|NCT01290263|O2|Outcome|Cohort A: AMG 386 30 mg/kg|All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
283466|NCT01290263|O1|Outcome|All Cohort B Participants: AMG 386 + Bevacizumab|All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
283467|NCT01290263|E2|Reported Event|Cohort A: AMG 386 30 mg/kg|All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
283468|NCT01290263|E1|Reported Event|Cohort B: AMG 386 + Bevacizumab|All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
283469|NCT01290237|B3|Baseline|Total|Total of all reporting groups
283470|NCT01290237|B2|Baseline|Control|"Intravenous vancomycin 20 mg/kg/dose every 8 hours~intravenous vancomycin hydrochloride: see description of study arms"
283471|NCT01290237|B1|Baseline|Vancomycin Loading Dose|"Intravenous vancomycin 30 mg/kg/dose once, followed 8 hours later by 20 mg/kg/dose every 8 hours~intravenous vancomycin hydrochloride: see description of study arms"
283472|NCT01290237|P2|Participant Flow|Control|"Intravenous vancomycin 20 mg/kg/dose every 8 hours~intravenous vancomycin hydrochloride: see description of study arms"
283473|NCT01290237|P1|Participant Flow|Vancomycin Loading Dose|"Intravenous vancomycin 30 mg/kg/dose once, followed 8 hours later by 20 mg/kg/dose every 8 hours~intravenous vancomycin hydrochloride: see description of study arms"
283474|NCT01290237|O2|Outcome|Conventional Dose|as above
283475|NCT01290237|O1|Outcome|Loading Dose|As above
283476|NCT01290237|O2|Outcome|Control|"Intravenous vancomycin 20 mg/kg/dose every 8 hours~intravenous vancomycin hydrochloride: see description of study arms"
283477|NCT01290237|O1|Outcome|Vancomycin Loading Dose|"Intravenous vancomycin 30 mg/kg/dose once, followed 8 hours later by 20 mg/kg/dose every 8 hours~intravenous vancomycin hydrochloride: see description of study arms"
283478|NCT01290237|E2|Reported Event|Control|"Intravenous vancomycin 20 mg/kg/dose every 8 hours~intravenous vancomycin hydrochloride: see description of study arms"
283479|NCT01290237|E1|Reported Event|Vancomycin Loading Dose|"Intravenous vancomycin 30 mg/kg/dose once, followed 8 hours later by 20 mg/kg/dose every 8 hours~intravenous vancomycin hydrochloride: see description of study arms"
283480|NCT01290224|B1|Baseline|Sham Procedure + Scrambler Treatment|
283481|NCT01290224|P1|Participant Flow|Sham Procedure + Scrambler Treatment|
283482|NCT01290224|O1|Outcome|Sham Procedure + Scrambler Treatment|
283483|NCT01290224|O1|Outcome|Sham Procedure + Scrambler Treatment|
283484|NCT01290224|O1|Outcome|Sham Procedure + Scrambler Treatment|
283485|NCT01290224|O1|Outcome|Sham Procedure + Scrambler Treatment|
283486|NCT01290224|O1|Outcome|Sham Procedure + Scrambler Treatment|
283487|NCT01290224|O2|Outcome|Scrambler Therapy (Day 2)|
283488|NCT01290224|O1|Outcome|Sham Procedure (Day 1 )|
283489|NCT01290224|O1|Outcome|Sham Procedure + Scrambler Treatment|
283490|NCT01290224|E1|Reported Event|Sham Procedure + Scrambler Treatment|
283491|NCT01290094|B1|Baseline|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
283492|NCT01290094|P1|Participant Flow|Ibandronate|Participants received 3 milligrams (mg) ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
283493|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
283494|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
283496|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
283497|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
283498|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
283499|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
283500|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
283501|NCT01290094|E1|Reported Event|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for 9 months (total of 4 injections).
283502|NCT01290068|B3|Baseline|Total|Total of all reporting groups
283503|NCT01290068|B2|Baseline|Monofocal IOL|Monofocal IOL, bilateral implantation
283504|NCT01290068|B1|Baseline|Multifocal IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
283505|NCT01290068|P2|Participant Flow|Monofocal IOL|Monofocal IOL, bilateral implantation
283506|NCT01290068|P1|Participant Flow|Multifocal IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
283507|NCT01290068|O2|Outcome|Monofocal IOL|Monofocal IOL, bilateral implantation
283508|NCT01290068|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
283509|NCT01290068|O2|Outcome|Monofocal IOL|Monofocal IOL, bilateral implantation
283510|NCT01290068|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
283511|NCT01290068|O2|Outcome|Monofocal IOL|Monofocal IOL, bilateral implantation
283512|NCT01290068|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
283513|NCT01290068|O2|Outcome|Monofocal IOL|Monofocal IOL, bilateral implantation
283514|NCT01290068|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
283515|NCT01290068|E2|Reported Event|Monofocal IOL|Monofocal IOL, bilateral implantation
283516|NCT01290068|E1|Reported Event|Multifocal IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
283517|NCT01290029|B1|Baseline|Cinacalcet 0.25 mg/kg|Participants were to receive a single oral dose of 0.25 mg/kg cinacalcet on day 1.
283518|NCT01290029|P1|Participant Flow|Cinacalcet 0.25 mg/kg|Participants were to receive a single oral dose of 0.25 mg/kg cinacalcet on day 1.
283519|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
283520|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
283521|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
283522|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
283523|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
283524|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
283525|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
283526|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
283527|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
283528|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
283529|NCT01290029|E1|Reported Event|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
283530|NCT01289990|B14|Baseline|Total|Total of all reporting groups
283531|NCT01289990|B13|Baseline|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching Empagliflozin~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
283532|NCT01289990|B12|Baseline|Empagliflozin 25 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
283533|NCT01289990|B11|Baseline|Empagliflozin 10 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg"
283534|NCT01289990|B10|Baseline|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching Empagliflozin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
283535|NCT01289990|B9|Baseline|Empagliflozin 25 mg (Metformin)|"Patients rolled over from trial 1245.23~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
283536|NCT01289990|B8|Baseline|Empagliflozin 10 mg (Metformin)|"Patients rolled over from trial 1245.23~Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg~Empagliflozin 10 mg: Empagliflozin 10 mg once daily"
283537|NCT01289990|B7|Baseline|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching Empagliflozin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
283538|NCT01289990|B6|Baseline|Empagliflozin 25 mg (Pioglitazone)|"Patients rolled over from trial 1245.19~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
283539|NCT01289990|B5|Baseline|Empagliflozin 10 mg (Pioglitazone)|"Patients rolled over from trial 1245.19~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg"
285990|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
283540|NCT01289990|B4|Baseline|Sitagliptin 100 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching Empagliflozin 25 mg~Placebo: Placebo matching Empagliflozin 10 mg~Sitagliptin 100 mg: Sitagliptin once daily"
283541|NCT01289990|B3|Baseline|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching Empagliflozin / Sitagliptin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 25 mg"
283542|NCT01289990|B2|Baseline|Empagliflozin 25 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Sitagliptin~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
283543|NCT01289990|B1|Baseline|Empagliflozin 10 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 25 mg"
283544|NCT01289990|P13|Participant Flow|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching Empagliflozin~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
283545|NCT01289990|P12|Participant Flow|Empagliflozin 25 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
283546|NCT01289990|P11|Participant Flow|Empagliflozin 10 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg"
283547|NCT01289990|P10|Participant Flow|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching Empagliflozin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
283548|NCT01289990|P9|Participant Flow|Empagliflozin 25 mg (Metformin)|"Patients rolled over from trial 1245.23~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
283549|NCT01289990|P8|Participant Flow|Empagliflozin 10 mg (Metformin)|"Patients rolled over from trial 1245.23~Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg~Empagliflozin 10 mg: Empagliflozin 10 mg once daily"
283550|NCT01289990|P7|Participant Flow|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching Empagliflozin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
283551|NCT01289990|P6|Participant Flow|Empagliflozin 25 mg (Pioglitazone)|"Patients rolled over from trial 1245.19~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
283552|NCT01289990|P5|Participant Flow|Empagliflozin 10 mg (Pioglitazone)|"Patients rolled over from trial 1245.19~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg"
283553|NCT01289990|P4|Participant Flow|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching Empagliflozin 25 mg~Placebo: Placebo matching Empagliflozin 10 mg~Sitagliptin 100mg: Sitagliptin once daily"
283554|NCT01289990|P3|Participant Flow|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching Empagliflozin / Sitagliptin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 25 mg"
283555|NCT01289990|P2|Participant Flow|Empagliflozin 25 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 10 mg"
283556|NCT01289990|P1|Participant Flow|Empagliflozin 10 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 25 mg"
283557|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283558|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283559|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
283560|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283561|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283562|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
283563|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283564|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283565|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
283566|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
283567|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
283568|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283569|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
283570|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283571|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283572|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
283573|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283574|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283575|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
283576|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283577|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283578|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
283579|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
283580|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
283581|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283582|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
283583|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283584|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283585|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
283586|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283587|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283588|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
283589|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283590|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283591|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
283592|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
283593|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
283594|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283595|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
283596|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283597|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283598|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
283599|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283600|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283601|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
283602|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283603|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283604|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
283605|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
283606|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
283607|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283608|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
283609|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283610|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283611|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
283612|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283613|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283614|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
283615|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283616|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283617|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
283618|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
283619|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
283620|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283621|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
283622|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283623|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283624|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
283625|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283626|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283627|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
283628|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283629|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283630|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
285991|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
283631|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
283632|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
283633|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283634|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
283635|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283636|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283637|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
283638|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283639|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283640|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
283641|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283642|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283643|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
283644|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
283645|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
283646|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283647|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
283648|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283649|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283650|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
283651|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283652|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283653|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
283654|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283655|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283656|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
283657|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
283658|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
283659|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283660|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
283882|NCT01289639|O2|Outcome|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
283661|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283662|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283663|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
283664|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283665|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283666|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
283667|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283668|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283669|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
283670|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
283671|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
283672|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283673|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
283674|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283675|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283676|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
283677|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283678|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283679|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
283680|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283681|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283682|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
283683|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
283684|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
283685|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283686|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
283687|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283688|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283689|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
283690|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283691|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283692|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
283693|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283694|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283695|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
283696|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
283697|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
283698|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283699|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
283700|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283701|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283702|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
283703|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283704|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283705|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
283706|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283707|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283708|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
283709|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
283710|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
283711|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283712|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
283713|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283714|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283715|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
283716|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283717|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283718|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
283719|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
283720|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283721|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
283722|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
283723|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
283724|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
283725|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
283726|NCT01289990|E13|Reported Event|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from 1245.23~Placebo tablets matching Empagliflozin~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
283727|NCT01289990|E12|Reported Event|Empagliflozin 25 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
283728|NCT01289990|E11|Reported Event|Empagliflozin 10 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg"
283729|NCT01289990|E10|Reported Event|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching Empagliflozin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
283730|NCT01289990|E9|Reported Event|Empagliflozin 25 mg (Metformin)|"Patients rolled over from trial 1245.23~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
283731|NCT01289990|E8|Reported Event|Empagliflozin 10 mg (Metformin)|"Patients rolled over from trial 1245.23~Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg~Empagliflozin 10 mg: Empagliflozin 10 mg once daily"
283732|NCT01289990|E7|Reported Event|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching Empagliflozin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
283733|NCT01289990|E6|Reported Event|Empagliflozin 25 mg (Pioglitazone)|"Patients rolled over from trial 1245.19~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
283734|NCT01289990|E5|Reported Event|Empagliflozin 10 mg (Pioglitazone)|"Patients rolled over from trial 1245.19~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg"
283735|NCT01289990|E4|Reported Event|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching Empagliflozin 25 mg~Placebo: Placebo matching Empagliflozin 10 mg~Sitagliptin 100mg: Sitagliptin once daily"
283736|NCT01289990|E3|Reported Event|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching Empagliflozin / Sitagliptin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 25 mg"
283737|NCT01289990|E2|Reported Event|Empagliflozin 25 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 10 mg"
283738|NCT01289990|E1|Reported Event|Empagliflozin 10 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 25 mg"
283739|NCT01289912|B3|Baseline|Total|Total of all reporting groups
283740|NCT01289912|B2|Baseline|Placebo|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.~Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time (delete: each day) in the morning after a light, nonfat breakfast."
283741|NCT01289912|B1|Baseline|RAD001|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.~RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time (delete: each day) in the morning after a light, nonfat breakfast."
283742|NCT01289912|P2|Participant Flow|Placebo|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.~Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time (delete: each day) in the morning after a light, nonfat breakfast."
283743|NCT01289912|P1|Participant Flow|RAD001|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.~RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time (delete: each day) in the morning after a light, nonfat breakfast."
283744|NCT01289912|O4|Outcome|RAD001 - 6 Months|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.~RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast."
283883|NCT01289639|O1|Outcome|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
283745|NCT01289912|O3|Outcome|Placebo - 6 Months|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.~Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast."
283746|NCT01289912|O2|Outcome|RAD001 - Baseline|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.~RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive."
283747|NCT01289912|O1|Outcome|Placebo - Baseline|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.~Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive."
283748|NCT01289912|O4|Outcome|RAD001 - 6 Months|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.~RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast."
283749|NCT01289912|O3|Outcome|Placebo - 6 Months|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.~Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast."
283750|NCT01289912|O2|Outcome|RAD001 - Baseline|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.~RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive."
283751|NCT01289912|O1|Outcome|Placebo - Baseline|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.~Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive."
283752|NCT01289912|O4|Outcome|RAD001 - 6 Months|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.~RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast."
283753|NCT01289912|O3|Outcome|Placebo - 6 Months|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.~Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast."
283754|NCT01289912|O2|Outcome|RAD001 - Baseline|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.~RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive."
283755|NCT01289912|O1|Outcome|Placebo - Baseline|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.~Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive."
283756|NCT01289912|O2|Outcome|Placebo|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.~Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast."
283757|NCT01289912|O1|Outcome|RAD001|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.~RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast."
283758|NCT01289912|O2|Outcome|Placebo|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.~Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast."
283884|NCT01289639|O3|Outcome|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
283759|NCT01289912|O1|Outcome|RAD001|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.~RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast."
283760|NCT01289912|O4|Outcome|RAD001 - 6 Months|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. 6 months.~RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive."
283761|NCT01289912|O3|Outcome|Placebo - 6 Months|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. 6 months.~Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast."
283762|NCT01289912|O2|Outcome|RAD001 - Baseline|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. Baseline.~RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast."
283763|NCT01289912|O1|Outcome|Placebo - Baseline|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Baseline.~Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive."
283764|NCT01289912|O4|Outcome|RAD001 - 6 Months|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.~RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast."
283765|NCT01289912|O3|Outcome|Placebo - 6 Months|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.~Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast."
283766|NCT01289912|O2|Outcome|RAD001 - Baseline|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.~RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive."
283767|NCT01289912|O1|Outcome|Placebo - Baseline|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.~Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive."
283768|NCT01289912|O2|Outcome|Placebo|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.~Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time (delete: each day) in the morning after a light, nonfat breakfast."
283769|NCT01289912|O1|Outcome|RAD001|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.~RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time (delete: each day) in the morning after a light, nonfat breakfast."
283770|NCT01289912|E2|Reported Event|Placebo|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.~Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time (delete: each day) in the morning after a light, nonfat breakfast."
283771|NCT01289912|E1|Reported Event|RAD001|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.~RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.~Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time (delete: each day) in the morning after a light, nonfat breakfast."
283772|NCT01289847|B1|Baseline|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
283773|NCT01289847|P1|Participant Flow|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
283774|NCT01289847|O1|Outcome|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
283775|NCT01289847|O1|Outcome|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
283776|NCT01289847|O1|Outcome|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
283777|NCT01289847|O1|Outcome|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
283778|NCT01289847|O1|Outcome|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
283779|NCT01289847|O1|Outcome|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
283780|NCT01289847|E1|Reported Event|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
283781|NCT01289821|B1|Baseline|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L‑folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
283782|NCT01289821|P1|Participant Flow|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L‑folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
283783|NCT01289821|O1|Outcome|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L‑folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
283784|NCT01289821|O1|Outcome|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L‑folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
283785|NCT01289821|O1|Outcome|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L‑folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
283786|NCT01289821|O1|Outcome|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L‑folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
283787|NCT01289821|O1|Outcome|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L‑folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
283788|NCT01289821|O1|Outcome|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L‑folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
283885|NCT01289639|O2|Outcome|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
283886|NCT01289639|O1|Outcome|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
283789|NCT01289821|E1|Reported Event|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m2 D/L folinic acid or 200 mg/m2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m2 IV bolus injection immediately followed by a 5-FU 2400 mg/m2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
283790|NCT01289782|B3|Baseline|Total|Total of all reporting groups
283791|NCT01289782|B2|Baseline|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283792|NCT01289782|B1|Baseline|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283793|NCT01289782|P2|Participant Flow|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283794|NCT01289782|P1|Participant Flow|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283795|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283796|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283797|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283798|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283799|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283800|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283801|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283802|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283803|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283804|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283805|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283806|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283807|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283808|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283809|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283810|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283811|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283812|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283813|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283814|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283815|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283816|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283817|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283818|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283819|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283820|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283821|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283822|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283823|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283824|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283825|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283826|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283827|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283828|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283887|NCT01289639|E3|Reported Event|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
283888|NCT01289639|E2|Reported Event|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
283829|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283830|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283831|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283832|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283833|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283834|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283835|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283836|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283837|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283838|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283839|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283840|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283841|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283842|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283843|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283844|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283845|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283846|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283847|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283848|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283889|NCT01289639|E1|Reported Event|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
283890|NCT01289574|B4|Baseline|Total|Total of all reporting groups
283849|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283850|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283851|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283852|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283853|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283854|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283855|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283856|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283857|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283858|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283859|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283860|NCT01289782|E2|Reported Event|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
283861|NCT01289782|E1|Reported Event|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
283862|NCT01289639|B4|Baseline|Total|Total of all reporting groups
283863|NCT01289639|B3|Baseline|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
283864|NCT01289639|B2|Baseline|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
283865|NCT01289639|B1|Baseline|Arm 1|"matching placebo for fenofibrate 1 po qd~matching placebo for pioglitazone 1 po qd"
283866|NCT01289639|P3|Participant Flow|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
283867|NCT01289639|P2|Participant Flow|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
283868|NCT01289639|P1|Participant Flow|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
283869|NCT01289639|O3|Outcome|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
283870|NCT01289639|O2|Outcome|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
283871|NCT01289639|O1|Outcome|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
283872|NCT01289639|O3|Outcome|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
283873|NCT01289639|O2|Outcome|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
283874|NCT01289639|O1|Outcome|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
283875|NCT01289639|O3|Outcome|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
283876|NCT01289639|O2|Outcome|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
283877|NCT01289639|O1|Outcome|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
283878|NCT01289639|O3|Outcome|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
283879|NCT01289639|O2|Outcome|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
283880|NCT01289639|O1|Outcome|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
283881|NCT01289639|O3|Outcome|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
283894|NCT01289574|P3|Participant Flow|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
283895|NCT01289574|P2|Participant Flow|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
283896|NCT01289574|P1|Participant Flow|Vehicle Control Cream|ASC-J9: Cream for twice daily topical application to the face
283897|NCT01289574|O3|Outcome|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
283898|NCT01289574|O2|Outcome|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
283899|NCT01289574|O1|Outcome|Vehicle Control Cream|Vehicle control cream for twice daily topical application to the face
283900|NCT01289574|O3|Outcome|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
283901|NCT01289574|O2|Outcome|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
283902|NCT01289574|O1|Outcome|Vehicle Control Cream|ASC-J9: Cream for twice daily topical application to the face
283903|NCT01289574|O3|Outcome|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
283904|NCT01289574|O2|Outcome|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
283905|NCT01289574|O1|Outcome|Vehicle Control Cream|Vehicle control cream for twice daily topical application to the face
283906|NCT01289574|E3|Reported Event|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
283907|NCT01289574|E2|Reported Event|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
283908|NCT01289574|E1|Reported Event|Vehicle Control Cream|ASC-J9: Cream for twice daily topical application to the face
283909|NCT01289548|B4|Baseline|Total|Total of all reporting groups
283910|NCT01289548|B3|Baseline|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
283911|NCT01289548|B2|Baseline|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
283912|NCT01289548|B1|Baseline|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
283913|NCT01289548|P3|Participant Flow|Recipient PIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
283914|NCT01289548|P2|Participant Flow|Donor RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
283915|NCT01289548|P1|Participant Flow|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min
283916|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
283917|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
283918|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
283919|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
283920|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
283921|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
283922|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
283923|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
283924|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
283925|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
283926|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
283927|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
283928|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
283929|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
283930|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
283931|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
283932|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
283933|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
283934|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
283935|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
283936|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
283937|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
283938|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
283939|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
283940|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
283941|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
283942|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
283943|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
283944|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
283945|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
283946|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
283947|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
283948|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
283949|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
283950|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
283951|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
283952|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
283953|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
283954|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
283955|NCT01289548|E3|Reported Event|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
283956|NCT01289548|E2|Reported Event|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
283957|NCT01289548|E1|Reported Event|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
283958|NCT01289522|B1|Baseline|Cetuximab|"Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.~250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy.~500mg/m2 IV every 2 weeks during the maintenance therapy.~Drug: Cisplatin IV : 75 mg/m2 every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m2 every 3 weeks for 4 cycles~G-CSF support with lenograstim 150 microg./m2/day is delivered after each cycle of chemotherapy.~Biopsies: No intervention, only biopsy for translational project."
283959|NCT01289522|P1|Participant Flow|Cetuximab|"cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.~250 mg/m² over 60 minutes weekly on subsequent administrations~500mg/m2 every 2 weeks during the maintenance therapy. Drug: -Cisplatin IV : 75 mg/m2 every 3 weeks for 4 cycles~Docetaxel IV : 75 mg/m2 every 3 weeks for 4 cycles G-CSF support mandatory after each cycle of chemotherapy. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the 4th cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks."
283960|NCT01289522|O1|Outcome|Cetuximab|"Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according~cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.~250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy.~500mg/m² IV every 2 weeks during the maintenance therapy. Drug: Cisplatin IV : 75 mg/m² every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m² every 3 weeks for 4 cycles~G-CSF support with lenograstim 150 microg/m²/day is delivered after each cycle of chemotherapy.~Biopsies: No intervention, only biopsy for translational project."
285992|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
283961|NCT01289522|O1|Outcome|Cetuximab|"Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according~cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.~250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy.~500mg/m² IV every 2 weeks during the maintenance therapy. Drug: Cisplatin IV : 75 mg/m² every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m² every 3 weeks for 4 cycles~G-CSF support with lenograstim 150 microg/m²/day is delivered after each cycle of chemotherapy.~Biopsies: No intervention, only biopsy for translational project."
283962|NCT01289522|O1|Outcome|Cetuximab|"Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according~cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.~250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy.~500mg/m² IV every 2 weeks during the maintenance therapy. Drug: Cisplatin IV : 75 mg/m² every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m² every 3 weeks for 4 cycles~G-CSF support with lenograstim 150 microg/m²/day is delivered after each cycle of chemotherapy.~Biopsies: No intervention, only biopsy for translational project."
283963|NCT01289522|E1|Reported Event|Cetuximab|"Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.~250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy.~500mg/m2 IV every 2 weeks during the maintenance therapy.~Drug: Cisplatin IV : 75 mg/m2 every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m2 every 3 weeks for 4 cycles~G-CSF support with lenograstim 150 microg./m2/day is delivered after each cycle of chemotherapy.~Biopsies: No intervention, only biopsy for translational project."
283964|NCT01289418|B4|Baseline|Total|Total of all reporting groups
283965|NCT01289418|B3|Baseline|Health Care Workers in Halifax|Health Care Workers from Halifax
283966|NCT01289418|B2|Baseline|Health Care Workers in Toronto|Health Care Workers from Toronto
283967|NCT01289418|B1|Baseline|Health Care Workers in Quebec|Health care workers from Quebec
283968|NCT01289418|P1|Participant Flow|Health Care Workers|Health care workers from all hospitals
283969|NCT01289418|O1|Outcome|Health Care Workers From CHUQ Hospitals|
283970|NCT01289418|O1|Outcome|Health Care Workers|Health care workers with a valid email address
283971|NCT01289418|O1|Outcome|Health Care Workers|Health care workers with a valid e-mail address
283972|NCT01289418|E1|Reported Event|Health Care Workers From CHUQ Hospitals|
283973|NCT01289392|B4|Baseline|Total|Total of all reporting groups
283974|NCT01289392|B3|Baseline|Physical Exercise|"Aerobic and resistance physical exercises~Physical Exercise : aerobic and resistance Physical exercise, three times a week, for four months"
283975|NCT01289392|B2|Baseline|Oral Appliance|"Alternative treatment for obstructive sleep apnea patients~Oral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
283976|NCT01289392|B1|Baseline|Continuous Positive Airway Pressure (CPAP)|"CPAP is the gold standard treatment~Continuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
283977|NCT01289392|P3|Participant Flow|Physical Exercise|"Aerobic and resistance physical exercises~Physical Exercise : aerobic and resistance Physical exercise, three times a week, for four months"
283978|NCT01289392|P2|Participant Flow|Oral Appliance|"Alternative treatment for obstructive sleep apnea patients~Oral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
283979|NCT01289392|P1|Participant Flow|Continuous Positive Airway Pressure (CPAP)|"CPAP is the gold standard treatment~Continuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
283980|NCT01289392|O3|Outcome|Physical Exercise|"Aerobic and resistance physical exercises~Physical Exercise : aerobic and resistance Physical exercise, three times a week, for four months"
283981|NCT01289392|O2|Outcome|Oral Appliance|"Alternative treatment for obstructive sleep apnea patients~Oral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
283982|NCT01289392|O1|Outcome|Continuous Positive Airway Pressure (CPAP)|"CPAP is the gold standard treatment~Continuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
283983|NCT01289392|E3|Reported Event|Physical Exercise|"Aerobic and resistance physical exercises~Physical Exercise : aerobic and resistance Physical exercise, three times a week, for four months"
283984|NCT01289392|E2|Reported Event|Oral Appliance|"Alternative treatment for obstructive sleep apnea patients~Oral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
283985|NCT01289392|E1|Reported Event|Continuous Positive Airway Pressure (CPAP)|"CPAP is the gold standard treatment~Continuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
283986|NCT01289275|B5|Baseline|Total|Total of all reporting groups
283987|NCT01289275|B4|Baseline|Brief Hospital Counseling|Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital’s particular practices.
283988|NCT01289275|B3|Baseline|Telephone Counseling and Nicotine Patches|"Nicotine Patches: 8 weeks of nicotine patches at discharge.~Telephone Counseling: Proactive. Counseling includes a 30-40 minute pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse."
283989|NCT01289275|B2|Baseline|Nicotine Patches|"Nicotine Patches: Subjects randomized into the patch condition will receive 8 weeks of nicotine patches at discharge. The kit will contain 4 weeks of 21mg patches, 2 weeks of 14mg, and 2 weeks of 7mg.~Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital’s particular practices."
283990|NCT01289275|B1|Baseline|Telephone Counseling|Telephone Counseling: Proactive. Counseling includes a 30-40 minute comprehensive pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse. Counselors use a structured protocol so that there will be a record for each counseling call.
283991|NCT01289275|P4|Participant Flow|Brief Hospital Counseling|Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital’s particular practices.
283992|NCT01289275|P3|Participant Flow|Telephone Counseling and Nicotine Patches|"Nicotine Patches: 8 weeks of nicotine patches at discharge.~Telephone Counseling: Proactive. Counseling includes a 30-40 minute pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse."
283993|NCT01289275|P2|Participant Flow|Nicotine Patches|"Nicotine Patches: Subjects randomized into the patch condition will receive 8 weeks of nicotine patches at discharge. The kit will contain 4 weeks of 21mg patches, 2 weeks of 14mg, and 2 weeks of 7mg.~Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital’s particular practices."
283994|NCT01289275|P1|Participant Flow|Telephone Counseling|Telephone Counseling: Proactive. Counseling includes a 30-40 minute comprehensive pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse. Counselors use a structured protocol so that there will be a record for each counseling call.
283995|NCT01289275|O4|Outcome|Brief Hospital Counseling|Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital’s particular practices.
283996|NCT01289275|O3|Outcome|Telephone Counseling and Nicotine Patches|"Nicotine Patches: 8 weeks of nicotine patches at discharge.~Telephone Counseling: Proactive. Counseling includes a 30-40 minute pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse."
283997|NCT01289275|O2|Outcome|Nicotine Patches|"Nicotine Patches: Subjects randomized into the patch condition will receive 8 weeks of nicotine patches at discharge. The kit will contain 4 weeks of 21mg patches, 2 weeks of 14mg, and 2 weeks of 7mg.~Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital’s particular practices."
283998|NCT01289275|O1|Outcome|Telephone Counseling|Telephone Counseling: Proactive. Counseling includes a 30-40 minute comprehensive pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse. Counselors use a structured protocol so that there will be a record for each counseling call.
283999|NCT01289275|E4|Reported Event|Brief Hospital Counseling|Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital’s particular practices.
284000|NCT01289275|E3|Reported Event|Telephone Counseling and Nicotine Patches|"Nicotine Patches: 8 weeks of nicotine patches at discharge.~Telephone Counseling: Proactive. Counseling includes a 30-40 minute pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse."
284001|NCT01289275|E2|Reported Event|Nicotine Patches|"Nicotine Patches: Subjects randomized into the patch condition will receive 8 weeks of nicotine patches at discharge. The kit will contain 4 weeks of 21mg patches, 2 weeks of 14mg, and 2 weeks of 7mg.~Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital’s particular practices."
284002|NCT01289275|E1|Reported Event|Telephone Counseling|Telephone Counseling: Proactive. Counseling includes a 30-40 minute comprehensive pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse. Counselors use a structured protocol so that there will be a record for each counseling call.
284003|NCT01289210|B1|Baseline|VTX-2337 Plus Radiation|VTX-2337 plus radiotherapy: Radiation on Day 1. On Day 2, VTX-2337 3.0mg/m2 is administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then given weekly for 3 weeks in a 4 week cycle over 3 cycles.
284004|NCT01289210|P1|Participant Flow|VTX-2337 Plus Radiation|Day 1: radiation therapy; Day 2: VTX-2337 3.0mg/m2 administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then administered weekly for 3 weeks in a 4 week cycle over 3 cycles.
284005|NCT01289210|O1|Outcome|VTX-2337 Plus Radiation|Day 1: radiation therapy; Day 2: VTX-2337 3.0mg/m2 administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then admnistered weekly for 3 weeks in a 4 week cycle over 3 cycles.
284006|NCT01289210|E1|Reported Event|VTX-2337 Plus Radiation|VTX-2337 plus radiotherapy: Radiation on Day 1. On Day 2, VTX-2337 3.0mg/m2 is administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then given weekly for 3 weeks in a 4 week cycle over 3 cycles.
284007|NCT01289119|B7|Baseline|Total|Total of all reporting groups
284008|NCT01289119|B6|Baseline|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
284009|NCT01289119|B5|Baseline|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284010|NCT01289119|B4|Baseline|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284011|NCT01289119|B3|Baseline|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284012|NCT01289119|B2|Baseline|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284013|NCT01289119|B1|Baseline|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
284014|NCT01289119|P6|Participant Flow|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
284015|NCT01289119|P5|Participant Flow|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284016|NCT01289119|P4|Participant Flow|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284017|NCT01289119|P3|Participant Flow|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284018|NCT01289119|P2|Participant Flow|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284019|NCT01289119|P1|Participant Flow|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
284020|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
284021|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284022|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284023|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284024|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284025|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
284026|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
284027|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284028|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284029|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284030|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284031|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
284032|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
284033|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284034|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284035|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284036|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284037|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
284038|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
284039|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284040|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284041|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284042|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284043|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
284044|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
284045|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284046|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284126|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
284047|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284048|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284049|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
284050|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
284051|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284052|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284053|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284054|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284055|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
284056|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
284057|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284058|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284059|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284060|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284061|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
284062|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
284063|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284064|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284065|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284066|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284067|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
284068|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
284069|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284070|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284071|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284072|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284073|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
284074|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
284075|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284076|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284077|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284078|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284079|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
284080|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
284081|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284082|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284083|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284084|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284085|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
284086|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
284087|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284088|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284089|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284090|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284091|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
284092|NCT01289119|E6|Reported Event|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
284093|NCT01289119|E5|Reported Event|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284094|NCT01289119|E4|Reported Event|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284095|NCT01289119|E3|Reported Event|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
284096|NCT01289119|E2|Reported Event|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
284097|NCT01289119|E1|Reported Event|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
284098|NCT01289080|B3|Baseline|Total|Total of all reporting groups
284099|NCT01289080|B2|Baseline|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
284100|NCT01289080|B1|Baseline|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
284101|NCT01289080|P2|Participant Flow|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
284102|NCT01289080|P1|Participant Flow|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
284103|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairement were administered 3 mg brexpiprazole on Day 1.
284104|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
284105|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairement were administered 3 mg brexpiprazole on Day 1.
284106|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
284107|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairement were administered 3 mg brexpiprazole on Day 1.
284108|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
284109|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairement were administered 3 mg brexpiprazole on Day 1.
284110|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
284111|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
284112|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
284113|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
284114|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
284115|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
284116|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
284117|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
284118|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
284119|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole Day 1.
284120|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
284121|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
284122|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
284123|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
284124|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
284125|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
284127|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole Day 1.
284128|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
284129|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
284130|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
284131|NCT01289080|E1|Reported Event|Brexpiprazole 3mg|Participants with normal renal function and severe renal impairment were administered 3 mg brexpiprazole.
284132|NCT01289067|B1|Baseline|Satraplatin, Single Arm|Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
284133|NCT01289067|P1|Participant Flow|Satraplatin, Single Arm|Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
284134|NCT01289067|O1|Outcome|Satraplatin, Single Arm|Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
284135|NCT01289067|O1|Outcome|Satraplatin, Single Arm|Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
284136|NCT01289067|O1|Outcome|Satraplatin, Single Arm|Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
284137|NCT01289067|O1|Outcome|Satraplatin, Single Arm|Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
284138|NCT01289067|E1|Reported Event|Satraplatin, Single Arm|Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
284139|NCT01289041|B1|Baseline|All Patients|
284140|NCT01289041|P1|Participant Flow|All Patients|
284141|NCT01289041|O3|Outcome|All Patients|
284142|NCT01289041|O2|Outcome|Non-Activated Pl3K|
284143|NCT01289041|O1|Outcome|Activated Pl3K|
284144|NCT01289041|O3|Outcome|All Patients|
284145|NCT01289041|O2|Outcome|Non-Activated Pl3K|
284146|NCT01289041|O1|Outcome|Activated Pl3K|
284147|NCT01289041|O3|Outcome|All Patients|
284148|NCT01289041|O2|Outcome|Non-Activated Pl3K|
284149|NCT01289041|O1|Outcome|Activated Pl3K|
284150|NCT01289041|E1|Reported Event|All Patients|
284151|NCT01289028|B1|Baseline|Nilotinib|
284152|NCT01289028|P1|Participant Flow|Nilotinib|
284153|NCT01289028|O1|Outcome|Nilotinib|
284154|NCT01289028|O1|Outcome|Nilotinib|
284155|NCT01289028|O1|Outcome|Nilotinib|
284156|NCT01289028|O1|Outcome|Nilotinib|
284157|NCT01289028|O1|Outcome|Nilotinib|Per Protocol population
284158|NCT01289028|O1|Outcome|Nilotinib|ITT
284159|NCT01289028|O1|Outcome|Nilotinib|
284160|NCT01289028|O1|Outcome|Nilotinib|
284161|NCT01289028|O1|Outcome|Nilotinib|
284162|NCT01289028|E1|Reported Event|All Patients|All patients
284163|NCT01289015|B3|Baseline|Total|Total of all reporting groups
284164|NCT01289015|B2|Baseline|Placebo|Placebo : Topical; applied once daily for two weeks
284165|NCT01289015|B1|Baseline|NAFT-600|NAFT-600 : Topical; applied once daily for two weeks
284166|NCT01289015|P2|Participant Flow|Placebo|Placebo : Topical; applied once daily for two weeks
284167|NCT01289015|P1|Participant Flow|NAFT-600|NAFT-600 : Topical; applied once daily for two weeks
284168|NCT01289015|O2|Outcome|Placebo|Placebo : Topical; applied once daily for two weeks
284169|NCT01289015|O1|Outcome|NAFT-600|NAFT-600 : Topical; applied once daily for two weeks
284170|NCT01289015|O2|Outcome|Placebo|Placebo : Topical; applied once daily for two weeks
284171|NCT01289015|O1|Outcome|NAFT-600|NAFT-600 : Topical; applied once daily for two weeks
284172|NCT01289015|E2|Reported Event|Placebo|Placebo : Topical; applied once daily for two weeks
284173|NCT01289015|E1|Reported Event|NAFT-600|NAFT-600 : Topical; applied once daily for two weeks
284174|NCT01288976|B4|Baseline|Total|Total of all reporting groups
284175|NCT01288976|B3|Baseline|Mitral Valve Surgery|Patients with MR managed surgically (repair or replacement) based on standard hospital clinical practice. Mitral Valve Surgery: The Mitral Valve Surgery Group consists of patients with MR in whom the MR is managed surgically (repair or replacement) based on standard hospital clinical practice. Patients with concurrent coronary artery bypass grafting (CABG) or aortic/tricuspid valve or and other cardiac procedure except atrial fibrillation surgery are excluded.
284176|NCT01288976|B2|Baseline|Medical Management|Patients with MR managed nonsurgically based on standard hospital clinical practice. Medical Management: The NonSurgical Medically Managed Heart Failure (HF) Group consists of patients with mitral regurgitation (MR) in whom the MR is managed nonsurgically based on standard hospital clinical practice. Patients with MR who receive a pacemaker, Implantable Cardiac Defibrillator (ICD) and/or Cardiac Resynchronization Therapy (CRT) treatments may be included.
284177|NCT01288976|B1|Baseline|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
284178|NCT01288976|P3|Participant Flow|Mitral Valve Surgery|Patients with MR managed surgically (repair or replacement) based on standard hospital clinical practice. Mitral Valve Surgery: The Mitral Valve Surgery Group consists of patients with MR in whom the MR is managed surgically (repair or replacement) based on standard hospital clinical practice. Patients with concurrent coronary artery bypass grafting (CABG) or aortic/tricuspid valve or and other cardiac procedure except atrial fibrillation surgery are excluded.
284179|NCT01288976|P2|Participant Flow|Medical Management|Patients with MR managed nonsurgically based on standard hospital clinical practice. Medical Management: The NonSurgical Medically Managed Heart Failure (HF) Group consists of patients with mitral regurgitation (MR) in whom the MR is managed nonsurgically based on standard hospital clinical practice. Patients with MR who receive a pacemaker, Implantable Cardiac Defibrillator (ICD) and/or Cardiac Resynchronization Therapy (CRT) treatments may be included.
284180|NCT01288976|P1|Participant Flow|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
284181|NCT01288976|O1|Outcome|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
284182|NCT01288976|O1|Outcome|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
284183|NCT01288976|O1|Outcome|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
284184|NCT01288976|O1|Outcome|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
284185|NCT01288976|O1|Outcome|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
284186|NCT01288976|O1|Outcome|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
284187|NCT01288976|O1|Outcome|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
284188|NCT01288976|O1|Outcome|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
284189|NCT01288976|O1|Outcome|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
284190|NCT01288976|O1|Outcome|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
284191|NCT01288976|O1|Outcome|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
284192|NCT01288976|O1|Outcome|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
284193|NCT01288976|O1|Outcome|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
284194|NCT01288976|O1|Outcome|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
284195|NCT01288976|O1|Outcome|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
284196|NCT01288976|O1|Outcome|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
284197|NCT01288976|O1|Outcome|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
284198|NCT01288976|O1|Outcome|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
284199|NCT01288976|O1|Outcome|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
284200|NCT01288976|O1|Outcome|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
284201|NCT01288976|O1|Outcome|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
284202|NCT01288976|O1|Outcome|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
284203|NCT01288976|E3|Reported Event|Mitral Valve Surgery|Patients with MR managed surgically (repair or replacement) based on standard hospital clinical practice. Mitral Valve Surgery: The Mitral Valve Surgery Group consists of patients with MR in whom the MR is managed surgically (repair or replacement) based on standard hospital clinical practice. Patients with concurrent coronary artery bypass grafting (CABG) or aortic/tricuspid valve or and other cardiac procedure except atrial fibrillation surgery are excluded.
284234|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284377|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
284204|NCT01288976|E2|Reported Event|Medical Management|"Patients with MR managed nonsurgically based on standard hospital clinical practice.~Medical Management: The NonSurgical Medically Managed Heart Failure (HF) Group consists of patients with mitral regurgitation (MR) in whom the MR is managed nonsurgically based on standard hospital clinical practice. Patients with MR who receive a pacemaker, Implantable Cardiac Defibrillator (ICD) and/or Cardiac Resynchronization Therapy (CRT) treatments may be included."
284205|NCT01288976|E1|Reported Event|MitraClip Therapy|"Patients treated with the MitraClip System.~MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"
284206|NCT01288911|B3|Baseline|Total|Total of all reporting groups
284207|NCT01288911|B2|Baseline|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284208|NCT01288911|B1|Baseline|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284209|NCT01288911|P2|Participant Flow|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284210|NCT01288911|P1|Participant Flow|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284211|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284212|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284213|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284214|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284215|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284216|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284217|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284218|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284219|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284220|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284221|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284222|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284223|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284224|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284225|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284226|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284227|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284228|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284229|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284230|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284231|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284232|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284233|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284782|NCT01287117|B1|Baseline|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
284235|NCT01288911|E2|Reported Event|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284236|NCT01288911|E1|Reported Event|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
284237|NCT01288859|B1|Baseline|All Study Participants|All participants followed all the periods
284238|NCT01288859|P6|Participant Flow|Free Curcumin|Subjects consumed 2 portions of bread enriched with free curcumin (1g/100g portion, i.e. 2g/day)
284239|NCT01288859|P5|Participant Flow|Encapsulated Cocoa Polyphenols|Subjects consumed 3 nut cream portions (33g each) enriched with encapsulated cocoa polyphenols at dosage of 1.5g/day.
284240|NCT01288859|P4|Participant Flow|Control Cream|Subjects consumed 3 nut cream portions (33g each).
284241|NCT01288859|P3|Participant Flow|Free Cocoa Polyphenol|Subjects consumed 3 nut cream portions (33g each) enriched with cocoa polyphenols at dosage of 1.5g/day.
284242|NCT01288859|P2|Participant Flow|Encapsulated Curcumin + PQG|Subjects consumed 2 bread portions/day of bread enriched with micro-capsules containing curcumin at dosage of 1 g/100 g plus 0.1% of Piperine, Quercetin and Genistein (PQG) (2g curcumin + 0.2g PQG/day) for one day.
284243|NCT01288859|P1|Participant Flow|Encapsulated Curcumin|Subjects consumed 2 bread portions/day of bread enriched with micro-encapsulated curcumin(1g/100g portion, i.e. 2g/day)
284244|NCT01288859|O6|Outcome|Free Curcumin|Subjects consumed bread added with free curcumin
284245|NCT01288859|O5|Outcome|Encapsulated Cocoa Polyphenols|subjects consumed nut creams added with encapsulate cocoa-polyphenols
284246|NCT01288859|O4|Outcome|Control|Subjects consumed white bread or nut cream
284247|NCT01288859|O3|Outcome|Free Cocoa Polyphenol|subjects consumed nut creams added with cocoa polyphenols
284248|NCT01288859|O2|Outcome|Encapsulated Curcumin + PQG|subjects consumed bread containing encapsulated curcumin plus PQG (i.e. Piperine, Quercetin and Genistein)
284249|NCT01288859|O1|Outcome|Encapsulated Curcumin|subjects consumed bread containing encapsulated curcumin
284250|NCT01288859|O6|Outcome|Free Curcumin|Subjects consumed bread added with free curcumin
284251|NCT01288859|O5|Outcome|Encapsulated Cocoa Polyphenols|subjects consumed nut creams added with encapsulate cocoa-polyphenols
284252|NCT01288859|O4|Outcome|Control|Subjects consumed white bread or nut cream
284253|NCT01288859|O3|Outcome|Free Cocoa Polyphenol|subjects consumed nut creams added with cocoa polyphenols
284254|NCT01288859|O2|Outcome|Encapsulated Curcumin + PQG|subjects consumed bread containing encapsulated curcumin plus PQG (i.e. Piperine, Quercetin and Genistein)
284255|NCT01288859|O1|Outcome|Encapsulated Curcumin|subjects consumed bread containing encapsulated curcumin
284256|NCT01288859|O6|Outcome|Encapsulated Cocoa Polyphenols|subjects consumed cocoa-nut cream enriched with encapsulated cocoa polyphenols
284257|NCT01288859|O5|Outcome|Free Cocoa Polyphenols|subjects consumed cocoa-nut cream enriched with cocoa polyphenols in the free form
284258|NCT01288859|O4|Outcome|Control Cream|subjects consumed cocoa-nut cream
284259|NCT01288859|O3|Outcome|Encapsulated Curcumin + PQG|subjects consumed bread enriched with encapsulated curcumin plus piperine, quercetin and genistein
284260|NCT01288859|O2|Outcome|Encapsulated Curcumin|subjects consumed bread enriched with encapsulated curcumin
284261|NCT01288859|O1|Outcome|Free Curcumin|subjects consumed bread enriched with free curcumin
284262|NCT01288859|E6|Reported Event|Free Curcumin|Subjects consumed 2 portions of bread enriched with free curcumin (1g/100g portion, i.e. 2g/day)
284263|NCT01288859|E5|Reported Event|Encapsulated Cocoa Polyphenols|Subjects consumed 3 nut cream portions (33g each) enriched with encapsulated cocoa polyphenols at dosage of 1.5g/day.
284264|NCT01288859|E4|Reported Event|Control Cream|Subjects consumed 3 nut cream portions (33g each).
284265|NCT01288859|E3|Reported Event|Free Cocoa Polyphenol|Subjects consumed 3 nut cream portions (33g each) enriched with cocoa polyphenols at dosage of 1.5g/day.
284266|NCT01288859|E2|Reported Event|Encapsulated Curcumin + PQG|Subjects consumed 2 bread portions/day of bread enriched with micro-capsules containing curcumin at dosage of 1 g/100 g plus 0.1% of Piperine, Quercetin and Genistein (PQG) (2g curcumin + 0.2g PQG/day) for one day.
284267|NCT01288859|E1|Reported Event|Encapsulated Curcumin|Subjects consumed 2 bread portions/day of bread enriched with micro-encapsulated curcumin(1g/100g portion, i.e. 2g/day)
284268|NCT01288833|B3|Baseline|Total|Total of all reporting groups
284269|NCT01288833|B2|Baseline|Current HD NBI Colonoscopy System|Use of standard focus for optical diagnosis
284270|NCT01288833|B1|Baseline|Close Focus HD NBI Colonoscopy System|"Use of close focus to make optical diagnosis~Close focus HD NBI Colonoscopy System: Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth."
284271|NCT01288833|P2|Participant Flow|Current HD NBI Colonoscopy System|Use of standard focus for optical diagnosis
284272|NCT01288833|P1|Participant Flow|Close Focus HD NBI Colonoscopy System|"Use of close focus to make optical diagnosis~Close focus HD NBI Colonoscopy System: Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth."
284273|NCT01288833|O2|Outcome|Current HD NBI Colonoscopy System|Use of standard focus for optical diagnosis
284274|NCT01288833|O1|Outcome|Close Focus HD NBI Colonoscopy System|"Use of close focus to make optical diagnosis~Close focus HD NBI Colonoscopy System: Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth."
284275|NCT01288833|O2|Outcome|Current HD NBI Colonoscopy System|Use of standard focus for optical diagnosis
284276|NCT01288833|O1|Outcome|Close Focus HD NBI Colonoscopy System|"Use of close focus to make optical diagnosis~Close focus HD NBI Colonoscopy System: Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth."
284277|NCT01288833|O2|Outcome|Current HD NBI Colonoscopy System|Use of standard focus for optical diagnosis
284378|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
284278|NCT01288833|O1|Outcome|Close Focus HD NBI Colonoscopy System|"Use of close focus to make optical diagnosis~Close focus HD NBI Colonoscopy System: Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth."
284279|NCT01288833|O2|Outcome|Current HD NBI Colonoscopy System|Use of standard focus for optical diagnosis
284280|NCT01288833|O1|Outcome|Close Focus HD NBI Colonoscopy System|"Use of close focus to make optical diagnosis~Close focus HD NBI Colonoscopy System: Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth."
284281|NCT01288833|O2|Outcome|Current HD NBI Colonoscopy System|Use of standard focus for optical diagnosis
284282|NCT01288833|O1|Outcome|Close Focus HD NBI Colonoscopy System|"Use of close focus to make optical diagnosis~Close focus HD NBI Colonoscopy System: Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth."
284283|NCT01288833|E2|Reported Event|Current HD NBI Colonoscopy System|Use of standard focus for optical diagnosis
284284|NCT01288833|E1|Reported Event|Close Focus HD NBI Colonoscopy System|"Use of close focus to make optical diagnosis~Close focus HD NBI Colonoscopy System: Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth."
284285|NCT01288781|B3|Baseline|Total|Total of all reporting groups
284286|NCT01288781|B2|Baseline|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
284287|NCT01288781|B1|Baseline|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
284288|NCT01288781|P2|Participant Flow|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
284289|NCT01288781|P1|Participant Flow|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
284290|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
284291|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
284292|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
284293|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
284294|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
284295|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
284296|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
284297|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
284298|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
284299|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
284300|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
284301|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
284302|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
284303|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
284304|NCT01288781|E2|Reported Event|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
284305|NCT01288781|E1|Reported Event|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
284306|NCT01288729|B3|Baseline|Total|Total of all reporting groups
284307|NCT01288729|B2|Baseline|Group 2 - Teflon Cathetar, the Steel|Participants will alternate between wearing the Quick-Set Teflon catheter for 7 days, then the Quick-Set Teflon for 7 days. They will wear each set twice starting with the Quick-Set Teflon set.
284308|NCT01288729|B1|Baseline|Group 1 - Steel Cathetar, Then Teflon|Participants will alternate between wearing the Sure-T Steel Infusion Set Catheter for 7 days, then the Quick-Set Teflon for 7 days.They will wear each set twice starting with the Sure-T Steel Infusion Set.
284309|NCT01288729|P2|Participant Flow|Group 2 - Teflon Cathetar, the Steel|Participants will alternate between wearing the Quick-Set Teflon catheter for 7 days, then the Quick-Set Teflon for 7 days. They will wear each set twice starting with the Quick-Set Teflon set.
284310|NCT01288729|P1|Participant Flow|Group 1: Steel Cathetar, Then Teflon|Participants will alternate between wearing the Sure-T Steel Infusion Set Catheter for 7 days, then the Quick-Set Teflon for 7 days.They will wear each set twice starting with the Sure-T Steel Infusion Set.
284311|NCT01288729|O2|Outcome|Quick-Set Teflon Catheter|"Participants will wear the Quick-Set Teflon catheter for 7 days (for a total of 14 days for the duration of the study).~Sure-T Stell Infusion Set Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time~Quick-Set Teflon Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time"
284330|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
284504|NCT01288079|B1|Baseline|1 mg BID TC-5214|
284312|NCT01288729|O1|Outcome|Sure-T Steel Infusion Set Catheter|"Participants will wear Sure-T Steel Infusion Set Catheter for 7 days (for a total of 14 days for the duration of the study)~Sure-T Stell Infusion Set Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time~Quick-Set Teflon Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time"
284313|NCT01288729|E2|Reported Event|Quick-Set Teflon Catheter|"Participants will wear the Quick-Set Teflon catheter for 7 days (for a total of 14 days for the duration of the study).~Sure-T Stell Infusion Set Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time~Quick-Set Teflon Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time"
284314|NCT01288729|E1|Reported Event|Sure-T Steel Infusion Set Catheter|"Participants will wear Sure-T Steel Infusion Set Catheter for 7 days (for a total of 14 days for the duration of the study)~Sure-T Stell Infusion Set Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time~Quick-Set Teflon Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time"
284315|NCT01288612|B4|Baseline|Total|Total of all reporting groups
284316|NCT01288612|B3|Baseline|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
284317|NCT01288612|B2|Baseline|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
284318|NCT01288612|B1|Baseline|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
284319|NCT01288612|P3|Participant Flow|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
284320|NCT01288612|P2|Participant Flow|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
284321|NCT01288612|P1|Participant Flow|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
284322|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
284323|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
284324|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
284325|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
284326|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
284327|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
284328|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
284329|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
284375|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
284331|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
284332|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
284333|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
284334|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
284335|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
284336|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
284337|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
284338|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
284339|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
284340|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
284341|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
284342|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
284343|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
284344|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
284345|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
284346|NCT01288612|E3|Reported Event|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
284347|NCT01288612|E2|Reported Event|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
284348|NCT01288612|E1|Reported Event|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
284376|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
284505|NCT01288079|P4|Participant Flow|Placebo|
284349|NCT01288534|B1|Baseline|Radiation Treatment|Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
284350|NCT01288534|P1|Participant Flow|Radiation Treatment|Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
284351|NCT01288534|O1|Outcome|Radiation Treatment|Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
284352|NCT01288534|O1|Outcome|Radiation Treatment|Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
284353|NCT01288534|O1|Outcome|Radiation Treatment|Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
284354|NCT01288534|O1|Outcome|Radiation Treatment|Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
284355|NCT01288534|O1|Outcome|Radiation Treatment|Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
284356|NCT01288534|E1|Reported Event|Radiation Treatment|Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
284357|NCT01288521|B3|Baseline|Total|Total of all reporting groups
284358|NCT01288521|B2|Baseline|Tacrolimus Alone, Then Tacrolimus + Ketoconazole|"Randomized, cross over design~Tacrolimus + Ketoconazole : Pharmacokinetic profiling of tacrolimus (AUC0-24h) in subjects receiving tacrolimus + keotconazole 200 mg every 12 hours x 3 doses.~Tacrolimus alone : Pharmacokinetic profiling of subjects on a stable dose of tacrolimus (AUC 0-24h)"
284359|NCT01288521|B1|Baseline|Tacrolimus + Ketoconazole, Then Tacrolimus Alone|"Randomized, cross over design~Tacrolimus + Ketoconazole : Pharmacokinetic profiling of tacrolimus (AUC0-24h) in subjects receiving tacrolimus + keotconazole 200 mg every 12 hours x 3 doses.~Tacrolimus alone : Pharmacokinetic profiling of subjects on a stable dose of tacrolimus (AUC 0-24h)"
284360|NCT01288521|P2|Participant Flow|Tacrolimus Alone, Then Tacrolimus + Ketoconazole|"Randomized, cross over design~Tacrolimus + Ketoconazole : Pharmacokinetic profiling of tacrolimus (AUC0-24h) in subjects receiving tacrolimus + keotconazole 200 mg every 12 hours x 3 doses.~Tacrolimus alone : Pharmacokinetic profiling of subjects on a stable dose of tacrolimus (AUC 0-24h)"
284361|NCT01288521|P1|Participant Flow|Tacrolimus + Ketoconazole, Then Tacrolimus Alone|"Randomized, cross over design~Tacrolimus + Ketoconazole : Pharmacokinetic profiling of tacrolimus (AUC0-24h) in subjects receiving tacrolimus + keotconazole 200 mg every 12 hours x 3 doses.~Tacrolimus alone : Pharmacokinetic profiling of subjects on a stable dose of tacrolimus (AUC 0-24h)"
284362|NCT01288521|O2|Outcome|Tacrolimus + Ketoconazole|Tacrolimus + Ketoconazole : Pharmacokinetic profiling of tacrolimus (AUC0-24h) in subjects receiving tacrolimus + keotconazole 200 mg every 12 hours x 3 doses.
284363|NCT01288521|O1|Outcome|Tacrolimus Alone|"cross over design~Tacrolimus alone : Pharmacokinetic profiling of subjects on a stable dose of tacrolimus (AUC 0-24h)"
284364|NCT01288521|E2|Reported Event|Tacrolimus + Ketoconazole|Tacrolimus + Ketoconazole : Pharmacokinetic profiling of tacrolimus (AUC0-24h) in subjects receiving tacrolimus + keotconazole 200 mg every 12 hours x 3 doses.
284365|NCT01288521|E1|Reported Event|Tacrolimus Alone|Tacrolimus alone : Pharmacokinetic profiling of subjects on a stable dose of tacrolimus (AUC 0-24h)
284366|NCT01288469|B4|Baseline|Total|Total of all reporting groups
284367|NCT01288469|B3|Baseline|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
284368|NCT01288469|B2|Baseline|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
284369|NCT01288469|B1|Baseline|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
284370|NCT01288469|P3|Participant Flow|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
284371|NCT01288469|P2|Participant Flow|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
284372|NCT01288469|P1|Participant Flow|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) subcutaneous (SC) injection every two weeks (Q2W) in combination with atorvastatin 80 mg orally once daily for 8 weeks.
284373|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
284374|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
284379|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
284380|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
284381|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
284382|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
284383|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
284384|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
284385|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
284386|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
284387|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
284388|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
284389|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
284390|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
284391|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
284392|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
284393|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
284394|NCT01288469|E3|Reported Event|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
284395|NCT01288469|E2|Reported Event|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
284396|NCT01288469|E1|Reported Event|Placebo + Atorvastatin 80mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
284397|NCT01288443|B7|Baseline|Total|Total of all reporting groups
284398|NCT01288443|B6|Baseline|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284399|NCT01288443|B5|Baseline|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284400|NCT01288443|B4|Baseline|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284401|NCT01288443|B3|Baseline|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284402|NCT01288443|B2|Baseline|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284403|NCT01288443|B1|Baseline|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284404|NCT01288443|P6|Participant Flow|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284405|NCT01288443|P5|Participant Flow|Alirocumab 200 mg Q4W|Alirocumab 200 mg every 4 weeks (Q4W) and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284406|NCT01288443|P4|Participant Flow|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284407|NCT01288443|P3|Participant Flow|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284408|NCT01288443|P2|Participant Flow|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284409|NCT01288443|P1|Participant Flow|Placebo|Placebo (for alirocumab) every 2 weeks (Q2W) for 12-weeks in combination with atorvastatin stable dose.
284410|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284411|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284412|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284413|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284414|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284415|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284416|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284417|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284418|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284419|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284420|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284421|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284422|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284423|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284424|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284425|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284426|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284427|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284428|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284429|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284430|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284431|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284432|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284433|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284434|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284435|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284436|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284437|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284438|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284439|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284440|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284441|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284442|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284443|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284444|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284445|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284446|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284447|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284448|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284449|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284450|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284451|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284452|NCT01288443|E6|Reported Event|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284453|NCT01288443|E5|Reported Event|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284454|NCT01288443|E4|Reported Event|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284455|NCT01288443|E3|Reported Event|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284456|NCT01288443|E2|Reported Event|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
284457|NCT01288443|E1|Reported Event|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
284458|NCT01288287|B1|Baseline|Safety Set (All Patients)|"Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic.~Safety Set consists of all patients entered into the study who took at least one dose of Certolizumab Pegol."
284459|NCT01288287|P1|Participant Flow|All Patients|Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic.
284460|NCT01288287|O2|Outcome|Week 12 Disease Activity Score (DAS) Non-Responders|Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
284461|NCT01288287|O1|Outcome|Week 12 Disease Activity Score (DAS) Responders|Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
284462|NCT01288287|O2|Outcome|Week 12 Disease Activity Score (DAS) Non-Responders|Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
284463|NCT01288287|O1|Outcome|Week 12 Disease Activity Score (DAS) Responders|Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
284464|NCT01288287|O2|Outcome|Week 12 Disease Activity Score (DAS) Non-Responders|Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
284465|NCT01288287|O1|Outcome|Week 12 Disease Activity Score (DAS) Responders|Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
284466|NCT01288287|O2|Outcome|Week 12 Disease Activity Score (DAS) Non-Responders|Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
284467|NCT01288287|O1|Outcome|Week 12 Disease Activity Score (DAS) Responders|Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
284468|NCT01288287|O2|Outcome|Week 12 Disease Activity Score (DAS) Non-Responders|Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
284469|NCT01288287|O1|Outcome|Week 12 Disease Activity Score (DAS) Responders|Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
284470|NCT01288287|E1|Reported Event|Safety Set (All Patients)|"Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic.~Safety Set consists of all patients entered into the study who took at least one dose of Certolizumab Pegol."
284471|NCT01288209|B3|Baseline|Total|Total of all reporting groups
284472|NCT01288209|B2|Baseline|TMC435 100 mg 24 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
284473|NCT01288209|B1|Baseline|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
284474|NCT01288209|P2|Participant Flow|TMC435 100 mg 24 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
284475|NCT01288209|P1|Participant Flow|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
284476|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
284477|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
284478|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
284479|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
284480|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
284481|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
284482|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
284483|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
284506|NCT01288079|P3|Participant Flow|60 mg QD Duloxetine|
284507|NCT01288079|P2|Participant Flow|4 mg BID TC-5214|
284508|NCT01288079|P1|Participant Flow|1 mg BID TC-5214|
284509|NCT01288079|O4|Outcome|Placebo|
284510|NCT01288079|O3|Outcome|60 mg QD Duloxetine|
284484|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
284485|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
284486|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
284487|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
284488|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
284489|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
284490|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
284491|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
284492|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
284493|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
284494|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
284495|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
284496|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
284497|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
284498|NCT01288209|E2|Reported Event|TMC435 100 mg 24 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
284499|NCT01288209|E1|Reported Event|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
284500|NCT01288079|B5|Baseline|Total|Total of all reporting groups
284501|NCT01288079|B4|Baseline|Placebo|
284502|NCT01288079|B3|Baseline|60 mg QD Duloxetine|
284503|NCT01288079|B2|Baseline|4 mg BID TC-5214|
284517|NCT01288027|B1|Baseline|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
284518|NCT01288027|P1|Participant Flow|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
284519|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
284520|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
284521|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
284522|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
284523|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
284524|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
284525|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
284526|NCT01288027|E1|Reported Event|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
284527|NCT01287897|B5|Baseline|Total|Total of all reporting groups
284528|NCT01287897|B4|Baseline|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284529|NCT01287897|B3|Baseline|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284530|NCT01287897|B2|Baseline|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284531|NCT01287897|B1|Baseline|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284532|NCT01287897|P4|Participant Flow|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284533|NCT01287897|P3|Participant Flow|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284534|NCT01287897|P2|Participant Flow|PF-04236921 10 Milligram (mg)|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284535|NCT01287897|P1|Participant Flow|Placebo|Placebo administered subcutaneously (SC) in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284536|NCT01287897|O4|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284537|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284538|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284539|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284540|NCT01287897|O3|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284541|NCT01287897|O2|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284542|NCT01287897|O1|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284543|NCT01287897|O3|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284544|NCT01287897|O2|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284545|NCT01287897|O1|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284546|NCT01287897|O3|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284547|NCT01287897|O2|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284548|NCT01287897|O1|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284549|NCT01287897|O2|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284550|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
285993|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
284551|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284552|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284553|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284554|NCT01287897|O2|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284555|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284556|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284557|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284558|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284559|NCT01287897|O2|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284560|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284561|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284562|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284563|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284564|NCT01287897|O2|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284565|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284566|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284567|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284568|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284569|NCT01287897|O2|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284570|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284571|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284572|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284573|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284574|NCT01287897|O2|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284575|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284576|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284577|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284578|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284579|NCT01287897|E4|Reported Event|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284580|NCT01287897|E3|Reported Event|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284581|NCT01287897|E2|Reported Event|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
326780|NCT01181011|O2|Outcome|Telmisartan 80mg|
284582|NCT01287897|E1|Reported Event|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
284583|NCT01287832|B3|Baseline|Total|Total of all reporting groups
284584|NCT01287832|B2|Baseline|High-dose Daptomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
284585|NCT01287832|B1|Baseline|High Dose Vancomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
284586|NCT01287832|P2|Participant Flow|High-dose Daptomycin|Daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
284587|NCT01287832|P1|Participant Flow|High Dose Vancomycin|Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
284588|NCT01287832|O2|Outcome|High-dose Daptomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
284589|NCT01287832|O1|Outcome|High Dose Vancomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
284590|NCT01287832|E2|Reported Event|High-dose Daptomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
284591|NCT01287832|E1|Reported Event|High Dose Vancomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
284592|NCT01287754|B3|Baseline|Total|Total of all reporting groups
284593|NCT01287754|B2|Baseline|Untreated|Participants without the EGFR mutation were followed for overall survival but did not undergo treatment. Additionally, participants positive for the EGFR mutation who were excluded from treatment were followed for overall survival.
284594|NCT01287754|B1|Baseline|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
284595|NCT01287754|P2|Participant Flow|Untreated|Participants without the EGFR mutation were followed for overall survival but did not receive treatment. Additionally, participants positive for the EGFR mutation who were excluded from treatment were followed for overall survival.
284596|NCT01287754|P1|Participant Flow|Erlotinib|Participants positive for the epidermal growth factor receptor (EGFR) mutation and who met eligibility criteria received treatment with erlotinib, 150 milligrams (mg) orally once daily until disease progression or unacceptable toxicity.
284597|NCT01287754|O1|Outcome|All Participants|All participants underwent EGFR mutation testing at Screening. Those positive for the EGFR mutation and who met eligibility criteria (n = 3) received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity. The remaining participants (n = 21) were followed for overall survival but did not receive treatment.
284598|NCT01287754|O2|Outcome|Untreated|Participants without the EGFR mutation were followed for overall survival but did not receive treatment. Additionally, participants positive for the EGFR mutation who were excluded from treatment were followed for overall survival.
284599|NCT01287754|O1|Outcome|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
284600|NCT01287754|O2|Outcome|Untreated|Participants without the EGFR mutation were followed for overall survival but did not receive treatment. Additionally, participants positive for the EGFR mutation who were excluded from treatment were followed for overall survival.
284601|NCT01287754|O1|Outcome|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
284602|NCT01287754|O1|Outcome|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
284603|NCT01287754|O1|Outcome|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
284604|NCT01287754|E1|Reported Event|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
284605|NCT01287741|B3|Baseline|Total|Total of all reporting groups
284606|NCT01287741|B2|Baseline|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284607|NCT01287741|B1|Baseline|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284608|NCT01287741|P2|Participant Flow|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284609|NCT01287741|P1|Participant Flow|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284733|NCT01287221|P1|Participant Flow|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
326781|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
284610|NCT01287741|O1|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284611|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284612|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284613|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284614|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284615|NCT01287741|O1|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284616|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284617|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284618|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284619|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284620|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284621|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284622|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284623|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284624|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284625|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284626|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284783|NCT01287117|P4|Participant Flow|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
284627|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284628|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284629|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284630|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284631|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284632|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284633|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284634|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284635|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284636|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284637|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284638|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284639|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284640|NCT01287741|E2|Reported Event|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284641|NCT01287741|E1|Reported Event|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
284642|NCT01287611|B3|Baseline|Total|Total of all reporting groups
284643|NCT01287611|B2|Baseline|Continuously Locked Closure Technique|Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
284644|NCT01287611|B1|Baseline|Purse String Closure Technique|Purse string closure: Uterine Kerr incision will be closed with purse string suture
284645|NCT01287611|P2|Participant Flow|Continuously Locked Closure Technique|Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
284646|NCT01287611|P1|Participant Flow|Purse String Closure Technique|Purse string closure: Uterine Kerr incision will be closed with purse string suture
284734|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
284735|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
284647|NCT01287611|O2|Outcome|Continuously Locked Closure Technique|"Eighty four patients were allocated to the control group. Due to expanded Kerr incisions 3 patients in control group did not receive their allocated intervention. In addition, 16 patients in the control group were lost to follow up and did not come to the sixth week check up. Statistical analysis is based on data from the remaining 65 study group.~Continuously locked closure technique: Uterine Kerr incision will be closed with continuously locked suturing"
284648|NCT01287611|O1|Outcome|Purse String Closure Technique|"Eighty four patients were allocated to the study group. Due to expanded Kerr incisions 4 patients in study group did not receive their allocated intervention. In addition, 29 patients in the study group were lost to follow up and did not come to the sixth week check up. Statistical analysis is based on data from the remaining 51 study group.~Purse string closure technique: Uterine Kerr incision will be closed with purse string suture"
284649|NCT01287611|O2|Outcome|Continuously Locked Closure Technique|Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
284650|NCT01287611|O1|Outcome|Purse String Closure Technique|Purse string closure: Uterine Kerr incision will be closed with purse string suture
284651|NCT01287611|E2|Reported Event|Continuously Locked Closure Technique|Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
284652|NCT01287611|E1|Reported Event|Purse String Closure Technique|Purse string closure: Uterine Kerr incision will be closed with purse string suture
284653|NCT01287416|B3|Baseline|Total|Total of all reporting groups
284654|NCT01287416|B2|Baseline|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
284655|NCT01287416|B1|Baseline|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
284656|NCT01287416|P2|Participant Flow|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
284657|NCT01287416|P1|Participant Flow|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
284658|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
284659|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
284660|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
284784|NCT01287117|P3|Participant Flow|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
284661|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
284662|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
284663|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
284664|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
284665|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
284666|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
284667|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
284668|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
284669|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
284736|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
284670|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
284671|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
284672|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
284673|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
284674|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
284675|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
284676|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
284677|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
284678|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
284737|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
284738|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
284679|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
284680|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
284681|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
284682|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
284683|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
284684|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
284685|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
284686|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
284687|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
284739|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
284688|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
284689|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
284690|NCT01287416|E2|Reported Event|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
284691|NCT01287416|E1|Reported Event|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
284692|NCT01287403|B1|Baseline|Entire Study Population|Includes groups randomized to receive either esterase wholegrain wheat flour first or liquid wholegrain wheat flour first or liquid wholegrain barley flour first or refined wheat flour first or wholegrain wheat flour first or wholegrain barley flour first
284693|NCT01287403|P1|Participant Flow|Six Products (Flours) Assigned Randomly (Cross Over)|"In a crossover design, all subjects were administered the 6 following products in a randomized order:~Esterase wholegrain wheat flour: a cereal flour treated with esterases to release phenolics (positive control for phenolic acids).~Refined wheat flour: a treated cereal flour mixed with milk (negative control).~Liquid whole grain wheat flour: a treated cereal flour mixed with milk.~Liquid wholegrain barley flour: a treated cereal flour mixed with milk.~Wholegrain wheat flour: a treated cereal flour mixed with milk.~Wholegrain barley flour: a treated cereal flour mixed with milk."
284694|NCT01287403|O6|Outcome|Wholegrain Barley Flour|A treated cereal flour mixed with milk.
284695|NCT01287403|O5|Outcome|Wholegrain Wheat Flour|A treated cereal flour mixed with milk.
284696|NCT01287403|O4|Outcome|Liquid Wholegrain Barley Flour|A treated cereal flour mixed with milk.
284697|NCT01287403|O3|Outcome|Liquid Whole Grain Wheat Flour|A treated cereal flour mixed with milk.
284698|NCT01287403|O2|Outcome|Refined Wheat Flour|A treated cereal flour mixed with milk(negative control).
284699|NCT01287403|O1|Outcome|Esterase Whole Grain Wheat Flour|A cereal flour treated with esterase to release phenolics (positive control for phenolic acids).
284700|NCT01287403|E6|Reported Event|Wholegrain Barley Flour|A treated cereal flour mixed with milk.
284701|NCT01287403|E5|Reported Event|Wholegrain Wheat Flour|A treated cereal flour mixed with milk.
284702|NCT01287403|E4|Reported Event|Liquid Wholegrain Barley Flour|A treated cereal flour mixed with milk.
284703|NCT01287403|E3|Reported Event|Liquid Whole Grain Wheat Flour|A treated cereal flour mixed with milk.
284704|NCT01287403|E2|Reported Event|Esterase Wholegrain Wheat Flour|A cereal flour treated with esterases to release phenolics (positive control for phenolic acids)
284705|NCT01287403|E1|Reported Event|Refined Wheat Flour|A treated cereal flour mixed with milk (negative control).
284706|NCT01287364|B3|Baseline|Total|Total of all reporting groups
284707|NCT01287364|B2|Baseline|Mometasone Followed by Ciclesonide HFA|mometasone nasal inhalation 200 μg once daily in first intervention period followed by a 7-14 day washout period after which the second intervention of ciclesonide hydrofluoroalkane (HFA) nasal aerosol 80 μg once daily will be administered
284708|NCT01287364|B1|Baseline|Ciclesonide HFA Followed by Mometasone|ciclesonide hydrofluoroalkane nasal aerosol (HFA) 80 μg once daily in first intervention period, followed by a 7-14 day washout period, after which the second intervention of mometasone nasal inhalation 200 μg once daily will be administered.
284709|NCT01287364|P2|Participant Flow|Mometasone Followed by Ciclesonide HFA|mometasone nasal inhalation 200 μg once daily in first intervention period followed by a 7-14 day washout period after which the second intervention of ciclesonide hydrofluoroalkane (HFA) nasal aerosol 80 μg once daily will be administered
284710|NCT01287364|P1|Participant Flow|Ciclesonide HFA Followed by Mometasone|ciclesonide hydrofluoroalkane nasal aerosol (HFA) 80 μg once daily in first intervention period, followed by a 7-14 day washout period, after which the second intervention of mometasone nasal inhalation 200 μg once daily will be administered.
284740|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
284741|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
284711|NCT01287364|O2|Outcome|Treatment Outcomes|Extraction Method: Principal Component Analysis. Rotation Method: Varimax with Kaiser Normalization. Treatment Outcomes Component reflects the perceived outcomes of drug treatment, including longer relief; symptom relief, if both were the same price; for feeling better about your appearance; for fewer problems with irritation to nose; faster relief; and how it makes your nose feel.
284712|NCT01287364|O1|Outcome|Treatment Process|Extraction Method: Principal Component Analysis. Rotation Method: Varimax with Kaiser Normalization. Treatment Process Component reflects preference on items pertaining to the perceived drug treatment process, including ease of use; convenience; flexibility in daily activities; taste; use in public; smell; fewer problems with medication running out of the nose; fewer problems with medication dripping down throat; and number of sprays per dose.
284713|NCT01287364|O3|Outcome|High Minus Low Response Group|Between Group Standardized Effect Sizes. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
284714|NCT01287364|O2|Outcome|High Response Group|Within Group Standardized Effect Sizes. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
284715|NCT01287364|O1|Outcome|Low Response Group|Within Group Standardized Effect Sizes. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
284716|NCT01287364|O3|Outcome|High Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85; n = 55), Medium Change (2.08 to 1.74; n = 56), or High Change (6.57 to 2.14; n = 55) groups..
284717|NCT01287364|O2|Outcome|Medium Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85; n = 55), Medium Change (2.08 to 1.74; n = 56), or High Change (6.57 to 2.14; n = 55) groups.
284718|NCT01287364|O1|Outcome|Low Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85), Medium Change (2.08 to 1.74), or High Change (6.57 to 2.14) groups.
284719|NCT01287364|O3|Outcome|High Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85), Medium Change (2.08 to 1.74), or High Change (6.57 to 2.14) groups.
284720|NCT01287364|O2|Outcome|Medium Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85), Medium Change (2.08 to 1.74), or High Change (6.57 to 2.14) groups.
284721|NCT01287364|O1|Outcome|Low Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85), Medium Change (2.08 to 1.74), or High Change (6.57 to 2.14) groups.
284722|NCT01287364|O3|Outcome|High Symptoms|Patients were assigned to baseline rTNSS categories of High Symptoms (9.33 - 12.00; n = 62). Results reported as difference in mean treatment satisfaction subscale score range 0-100 where higher represent greater satisfaction. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
284723|NCT01287364|O2|Outcome|Medium Symptoms|Patients were assigned to baseline rTNSS categories of Medium Symptoms (7.25 - 9.25; n = 61). Results reported as difference in mean treatment satisfaction subscale score range 0-100 where higher represent greater satisfaction. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
284724|NCT01287364|O1|Outcome|Low Symptoms|Patients were assigned to baseline rTNSS categories of Low Symptoms(3.00 - 7.17; n = 62). Results reported as difference in mean treatment satisfaction subscale score range 0-100 where higher represent greater satisfaction. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
284725|NCT01287364|O2|Outcome|Average Cronbach's Alpha (Standardized) Coefficients|Cronbach's alpha coefficient, which is a correlation coefficient ranging from 0.0 to 1.0 with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.
284726|NCT01287364|O1|Outcome|Average Cronbach's Alpha (Raw) Coefficients|Cronbach's alpha coefficient, which is a correlation coefficient ranging from 0.0 to 1.0 with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.
284727|NCT01287364|E2|Reported Event|Mometasone|mometasone nasal inhalation 200 μg once daily pooled
284728|NCT01287364|E1|Reported Event|Ciclesonide|ciclesonide hydrofluoroalkane nasal aerosol (HFA) 80 μg once daily pooled
284729|NCT01287221|B3|Baseline|Total|Total of all reporting groups
284730|NCT01287221|B2|Baseline|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
284731|NCT01287221|B1|Baseline|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
284732|NCT01287221|P2|Participant Flow|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
284742|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
284743|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
284744|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
284745|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
284746|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
284747|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
284748|NCT01287221|E2|Reported Event|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
284749|NCT01287221|E1|Reported Event|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
284750|NCT01287208|B3|Baseline|Total|Total of all reporting groups
284751|NCT01287208|B2|Baseline|Blinded|Activity monitor with no feedback
284752|NCT01287208|B1|Baseline|Unblinded|Activity monitor with visible and on-line feedback
284753|NCT01287208|P2|Participant Flow|Blinded|Subjects wear a blinded activity device and cannot see the activity on the device and cannot log on to the website where the data gets uploaded.
284754|NCT01287208|P1|Participant Flow|Unblinded|Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.
284755|NCT01287208|O2|Outcome|Blinded|"Subjects wear a blinded activity device and cannot see the activity on the device and cannot log on to the website where the data gets uploaded.~Activity device: Accelerometer that has all the steps, distance, calories, and sleep data blinded to the study subject"
284756|NCT01287208|O1|Outcome|Unblinded|"Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.~Activity monitor: The activity monitor is an accelerometer that records steps, distance, calories, and sleep"
284757|NCT01287208|O2|Outcome|Blinded|"Subjects wear a blinded activity device and cannot see the activity on the device and cannot log on to the website where the data gets uploaded.~Activity device: Accelerometer that has all the steps, distance, calories, and sleep data blinded to the study subject"
284758|NCT01287208|O1|Outcome|Unblinded|"Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.~Activity monitor: The activity monitor is an accelerometer that records steps, distance, calories, and sleep"
284759|NCT01287208|O2|Outcome|Blinded|"Subjects wear a blinded activity device and cannot see the activity on the device and cannot log on to the website where the data gets uploaded.~Activity device: Accelerometer that has all the steps, distance, calories, and sleep data blinded to the study subject"
284760|NCT01287208|O1|Outcome|Unblinded|"Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.~Activity monitor: The activity monitor is an accelerometer that records steps, distance, calories, and sleep"
284761|NCT01287208|O2|Outcome|Blinded|Subjects wear a blinded activity device and cannot see the activity on the device and cannot log on to the website where the data gets uploaded.
284762|NCT01287208|O1|Outcome|Unblinded|Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.
284763|NCT01287208|O2|Outcome|Blinded|Subjects wear a blinded activity device and cannot see the activity on the device and cannot log on to the website where the data gets uploaded.
284764|NCT01287208|O1|Outcome|Unblinded|Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.
284765|NCT01287208|E2|Reported Event|Blinded|Subjects wear a blinded activity device and cannot see the activity on the device and cannot log on to the website where the data gets uploaded.
284766|NCT01287208|E1|Reported Event|Unblinded|Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.
284767|NCT01287195|B1|Baseline|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
284768|NCT01287195|P1|Participant Flow|Oral OKT3|Participants with ulcerative colitis received 1 milligram (mg) Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
284769|NCT01287195|O1|Outcome|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
284770|NCT01287195|O1|Outcome|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
284771|NCT01287195|O1|Outcome|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
284772|NCT01287195|O1|Outcome|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
284773|NCT01287195|O1|Outcome|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
284774|NCT01287195|O1|Outcome|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
284775|NCT01287195|O1|Outcome|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
284776|NCT01287195|O1|Outcome|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
284777|NCT01287195|E1|Reported Event|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
284778|NCT01287117|B5|Baseline|Total|Total of all reporting groups
284779|NCT01287117|B4|Baseline|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
284780|NCT01287117|B3|Baseline|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
284781|NCT01287117|B2|Baseline|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
326782|NCT01181011|O2|Outcome|Telmisartan 80mg|
284785|NCT01287117|P2|Participant Flow|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
284786|NCT01287117|P1|Participant Flow|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
284787|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
284788|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
284789|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
284790|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
284791|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
284792|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
284793|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
284794|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
284795|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
284796|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
284797|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
284798|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
284799|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
284800|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
284801|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
284802|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
284803|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
284804|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
284805|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
284806|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
284807|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
284808|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
284809|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
284810|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
284811|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
284812|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
284813|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
284814|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
284815|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
284816|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
284817|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
284818|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
284819|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
284820|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
284821|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
284822|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
284823|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
284824|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
284825|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
284826|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
284827|NCT01287117|E4|Reported Event|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
284828|NCT01287117|E3|Reported Event|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
284829|NCT01287117|E2|Reported Event|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
284830|NCT01287117|E1|Reported Event|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
284831|NCT01287065|B1|Baseline|Placebo, FF/VI 100/25 µg AM, FF/VI 100/25 µg PM in 1 of 6 Seq|All participants received one of the following three treatments in one of three treatment periods from the Dry Powder Inhaler (DPI) for 14 days: placebo in the morning (AM) and evening (PM), Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM, and FF/VI inhalation powder 100/25 µg PM and placebo AM. Participants were randomized to receive treatment in one of the six following sequences (seq): (1) placebo, FF/VI 100/25 µg AM, FF/VI 100/25 µg PM; (2) placebo, FF/VI 100/25 µg PM, FF/VI 100/25 µg AM; (3) FF/VI 100/25 µg AM, FF/VI 100/25 µg PM, placebo; (4) FF/VI 100/25 µg AM, placebo, FF/VI 100/25 µg PM; (5) FF/VI 100/25 µg PM, placebo, FF/VI 100/25 µg AM; (6) FF/VI 100/25 µg PM, FF/VI 100/25 µg AM, placebo. Each 14 day treatment period was followed by a 14-21 day washout period.
284832|NCT01287065|P6|Participant Flow|Sequence 6: FF/VI 100/25 µg PM, FF/VI 100/25 µg AM, Placebo|Participants received FF/VI 100/25 µg PM, FF/VI 100/25 µg AM, and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
284833|NCT01287065|P5|Participant Flow|Sequence 5: FF/VI 100/25 µg PM, Placebo, FF/VI 100/25 µg AM|Participants received FF/VI 100/25 µg PM, placebo, and FF/VI 100/25 µg AM in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
284834|NCT01287065|P4|Participant Flow|Sequence 4: FF/VI 100/25 µg AM, Placebo, FF/VI 100/25 µg PM|Participants received FF/VI 100/25 µg AM, placebo, and FF/VI 100/25 µg PM in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
284835|NCT01287065|P3|Participant Flow|Sequence 3: FF/VI 100/25 µg AM, FF/VI 100/25 µg PM, Placebo|Participants received FF/VI 100/25 µg AM, FF/VI 100/25 µg PM, and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
284836|NCT01287065|P2|Participant Flow|Sequence 2: Placebo, FF/VI 100/25 µg PM, FF/VI 100/25 µg AM|Participants received placebo, FF/VI 100/25 µg PM, and FF/VI 100/25 µg AM in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
284837|NCT01287065|P1|Participant Flow|Sequence 1: Placebo, FF/VI 100/25 µg AM, FF/VI 100/25 µg PM|Participants received placebo, Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 micrograms (µg) AM, and FF/VI 100/25 µg PM in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day (OD) in the evening from a Dry Powder Inhaler (DPI) for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
284838|NCT01287065|O3|Outcome|FF/VI 100/25 µg PM|Participants received FF/VI inhalation powder 100/25 µg PM and placebo AM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
284839|NCT01287065|O2|Outcome|FF/VI 100/25 µg AM|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
284840|NCT01287065|O1|Outcome|Placebo|Participants received placebo in the morning (AM) and evening (PM) from the Dry Powder Inhaler (DPI) for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
284841|NCT01287065|O3|Outcome|FF/VI 100/25 µg PM|Participants received FF/VI inhalation powder 100/25 µg PM and placebo AM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
284842|NCT01287065|O2|Outcome|FF/VI 100/25 µg AM|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
284843|NCT01287065|O1|Outcome|Placebo|Participants received placebo in the morning (AM) and evening (PM) from the Dry Powder Inhaler (DPI) for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
284844|NCT01287065|O3|Outcome|FF/VI 100/25 µg PM|Participants received FF/VI inhalation powder 100/25 µg PM and placebo AM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
284845|NCT01287065|O2|Outcome|FF/VI 100/25 µg AM|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
284846|NCT01287065|O1|Outcome|Placebo|Participants received placebo in the morning (AM) and evening (PM) from the Dry Powder Inhaler (DPI) for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
284847|NCT01287065|O3|Outcome|FF/VI 100/25 µg PM|Participants received FF/VI inhalation powder 100/25 µg PM and placebo AM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
284848|NCT01287065|O2|Outcome|FF/VI 100/25 µg AM|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
284849|NCT01287065|O1|Outcome|Placebo|Participants received placebo in the morning (AM) and evening (PM) from the Dry Powder Inhaler (DPI) for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
284850|NCT01287065|E3|Reported Event|FF/VI 100/25 µg PM|Participants received FF/VI inhalation powder 100/25 µg PM and placebo AM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
284851|NCT01287065|E2|Reported Event|FF/VI 100/25 µg AM|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
285994|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
284852|NCT01287065|E1|Reported Event|Placebo|Participants received placebo in the morning (AM) and evening (PM) from the Dry Powder Inhaler (DPI) for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
284853|NCT01287039|B3|Baseline|Total|Total of all reporting groups
284854|NCT01287039|B2|Baseline|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284855|NCT01287039|B1|Baseline|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284856|NCT01287039|P2|Participant Flow|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284857|NCT01287039|P1|Participant Flow|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284858|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284859|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284860|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284861|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284862|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284863|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284864|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284865|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284866|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284867|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284868|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284869|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284870|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284871|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284872|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284873|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284874|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284875|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284876|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284877|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284878|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284879|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284880|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284881|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284882|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284883|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284884|NCT01287039|E2|Reported Event|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284885|NCT01287039|E1|Reported Event|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
284886|NCT01287013|B4|Baseline|Total|Total of all reporting groups
284887|NCT01287013|B3|Baseline|PILOT|Procedures performed with Xperguide without randomization to familiarize operators.
284888|NCT01287013|B2|Baseline|Conventional CT|Procedure performed with Conventional Computed Tomography (CT) image guidance
284889|NCT01287013|B1|Baseline|Cone Beam CT|Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation
284890|NCT01287013|P3|Participant Flow|PILOT|Procedures performed with Xperguide without randomization to familiarize operators.
284891|NCT01287013|P2|Participant Flow|Conventional CT|Procedure performed with Conventional Computed Tomography (CT) image guidance
284892|NCT01287013|P1|Participant Flow|Cone Beam CT|Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation
284893|NCT01287013|O2|Outcome|Conventional CT|Procedure performed with Conventional Computed Tomography (CT) image guidance
284894|NCT01287013|O1|Outcome|Cone Beam CT|Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation
284895|NCT01287013|O2|Outcome|Conventional CT|Procedure performed with Conventional Computed Tomography (CT) image guidance
284896|NCT01287013|O1|Outcome|Cone Beam CT|Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation
284897|NCT01287013|O2|Outcome|Conventional CT|Procedure performed with Conventional Computed Tomography (CT) image guidance
284898|NCT01287013|O1|Outcome|Cone Beam CT|Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation
284899|NCT01287013|O2|Outcome|Convetional CT|Procedure performed with Conventional Computed Tomography (CT) image guidance
284900|NCT01287013|O1|Outcome|Cone Beam CT|Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation
284901|NCT01287013|O2|Outcome|Conventional CT|Procedure performed with Conventional Computed Tomography (CT) image guidance
284902|NCT01287013|O1|Outcome|Cone Beam CT|Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation
284903|NCT01287013|E3|Reported Event|Pilot Arm|Pilot participants were enrolled to familiarize operators with performing Xperguide procedures.
284904|NCT01287013|E2|Reported Event|Conventional CT|Procedure performed with Conventional Computed Tomography (CT) image guidance
284905|NCT01287013|E1|Reported Event|Cone Beam CT|Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation
284906|NCT01286818|B1|Baseline|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
284907|NCT01286818|P1|Participant Flow|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
284908|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
284909|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
284910|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
284911|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
284926|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
284927|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
284928|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
284929|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
284912|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
284913|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
284914|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
284915|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
284916|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
284917|NCT01286818|E1|Reported Event|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
284918|NCT01286805|B3|Baseline|Total|Total of all reporting groups
284919|NCT01286805|B2|Baseline|Control Group|The control group received only a combined spinal-epidural.
284920|NCT01286805|B1|Baseline|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
284921|NCT01286805|P2|Participant Flow|Control Group|The control group received only a combined spinal-epidural.
284922|NCT01286805|P1|Participant Flow|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
284923|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
284924|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
284925|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
284974|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
284930|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
284931|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
284932|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
284933|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
284934|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
284935|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
284936|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
284937|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
284938|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
284939|NCT01286805|E2|Reported Event|Control Group|The control group received only a combined spinal-epidural.
284940|NCT01286805|E1|Reported Event|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
284941|NCT01286753|B3|Baseline|Total|Total of all reporting groups
284942|NCT01286753|B2|Baseline|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
284943|NCT01286753|B1|Baseline|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
284944|NCT01286753|P2|Participant Flow|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against vascular endothelial growth factor receptor 2 (VEGFR).
284945|NCT01286753|P1|Participant Flow|Tyrosine Kinase Inhibitor (TKI) Naive|Vemurafenib 960 milligrams (mg) orally twice daily in participants naive to any prior systemic TKI therapy.
284946|NCT01286753|O2|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
284947|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
284948|NCT01286753|O2|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
284949|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
284950|NCT01286753|O2|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
284951|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
284952|NCT01286753|O2|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
284953|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
284954|NCT01286753|O2|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
284955|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
284956|NCT01286753|O2|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
284957|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
284958|NCT01286753|O1|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
284959|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
284960|NCT01286753|E2|Reported Event|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
284961|NCT01286753|E1|Reported Event|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
284962|NCT01286740|B1|Baseline|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
284963|NCT01286740|P1|Participant Flow|FTC/RPV/TDF|Participants switched from their existing treatment regimen of efavirenz (EFV)/emtricitabine (FTC)/tenofovir disoproxil fumarate (tenofovir DF; TDF) to the FTC 200 mg/rilpivirine (RPV) 25 mg/TDF 300 mg single-table regimen (STR).
284964|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
284965|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
284966|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
284967|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
284968|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
284969|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
284970|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
284971|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
284972|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
284973|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
284975|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
284976|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
284977|NCT01286740|E1|Reported Event|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
284978|NCT01286558|B3|Baseline|Total|Total of all reporting groups
284979|NCT01286558|B2|Baseline|40 mg Telmisartan and 5 mg Amlodipine FDC|
284980|NCT01286558|B1|Baseline|80 mg Telmisartan and 5 mg Amlodipine FDC|
284981|NCT01286558|P2|Participant Flow|40 mg Telmisartan and 5 mg Amlodipine FDC|
284982|NCT01286558|P1|Participant Flow|80 mg Telmisartan and 5 mg Amlodipine FDC|
284983|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
284984|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
284985|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
284986|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
284987|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
284988|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
284989|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
284990|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
284991|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
284992|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
284993|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
284994|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
284995|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
284996|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
284997|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
284998|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
284999|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
285000|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
285001|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
285002|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
285003|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
285004|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
285005|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
285006|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
285007|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
285008|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
285009|NCT01286558|E2|Reported Event|40 mg Telmisartan and 5 mg Amlodipine FDC|
285010|NCT01286558|E1|Reported Event|80 mg Telmisartan and 5 mg Amlodipine FDC|
285011|NCT01286493|B1|Baseline|Rabies Vaccines on Day 0 and 3|"Cell culture Rabies vaccines on day 0 and 3~rabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360"
285012|NCT01286493|P1|Participant Flow|Rabies Vaccines on Day 0 and 3|"Cell culture Rabies vaccines on day 0 and 3~rabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360"
285013|NCT01286493|O1|Outcome|Rabies Vaccines on Day 0 and 3|"Cell culture Rabies vaccines on day 0 and 3~rabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360"
285014|NCT01286493|E1|Reported Event|Rabies Vaccines on Day 0 and 3|"Cell culture Rabies vaccines on day 0 and 3~rabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360"
285015|NCT01286480|B3|Baseline|Total|Total of all reporting groups
285016|NCT01286480|B2|Baseline|Usual Care|Youth seen in the Cardiology clinic see a nurse only to measure weight, height, and blood pressure. They rely on their cardiologist for information about their heart condition. The approach and amount of time taken by each cardiologist with a youth varies. Time-pressured clinic visits limit the opportunity to discuss many of the topics noted above.
285017|NCT01286480|B1|Baseline|Clinic-based Educational Intervention|Clinic-based Educational Intervention: This will involve a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. A MyHealth passport will be created covering the name of the teen's cardiac condition, previous cardiac interventions, and name and purpose of the teen's medications. Potential late cardiac complications and contact names and location of local adult CHD cardiologists will also be reviewed. Three scenarios regarding adolescent risk taking behaviors (written in the 3rd person) will be presented to the teen who will be asked what advice he/she would offer to the teen in each of those scenarios. The teen will be given a study email address and encouraged to contact the APN by email or text messaging with follow-up questions. If no contact is initiated after 1 week, the APN will email or text (based on preference) the youth, to discuss additional questions.
285018|NCT01286480|P2|Participant Flow|Usual Care|Participants allocated to the usual care group were unaware of the intervention being offered to the treatment group. This was intended to prevent contamination by self-education or other means.
285019|NCT01286480|P1|Participant Flow|Intervention Arm|The intervention was conducted by one of three experienced cardiology nurses following intervention-facilitation training and fidelity assurance. The intervention involved a meeting with the nurse and the participant, with the exception of three interventions also attended by a father (n=1), an uncle (n=1) and a participant’s friend (n=1). Interventions were held in a quiet room without other distractions, a short walk from the cardiology clinic. The order of the intervention was consistently followed, and the study nurse completed a log and field notes to document any difficulties that were encountered during the intervention and the participant’s reaction, level of engagement, questions and body language. Interventions were offered on the same day as a routine clinic visit, or at a later date, depending on the participant’s preference.
326783|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
285020|NCT01286480|O2|Outcome|Usual Care|Youth seen in the Cardiology clinic see a nurse only to measure weight, height, and blood pressure. They rely on their cardiologist for information about their heart condition. The approach and amount of time taken by each cardiologist with a youth varies. Time-pressured clinic visits limit the opportunity to discuss many of the topics noted above.
285021|NCT01286480|O1|Outcome|Intervention|This involves a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. A MyHealth passport is created covering the name of the teen's cardiac condition, previous cardiac interventions, and name and purpose of the teen's medications. Potential late cardiac complications and contact names and location of local adult CHD cardiologists are also reviewed. Three scenarios regarding adolescent risk taking behaviors (written in the 3rd person) are presented to the teen who will be asked what advice he/she would offer to the teen in each of those scenarios. The teen will be given a study email address and encouraged to contact the APN by email or text messaging with follow-up questions. If no contact is initiated after 1 week, the APN will email or text (based on preference) the youth, to discuss additional questions.
285022|NCT01286480|O2|Outcome|Usual Care|Youth seen in the Cardiology clinic see a nurse only to measure weight, height, and blood pressure. They rely on their cardiologist for information about their heart condition. The approach and amount of time taken by each cardiologist with a youth varies. Time-pressured clinic visits limit the opportunity to discuss many of the topics noted above.
285023|NCT01286480|O1|Outcome|Intervention|This involves a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. A MyHealth passport is created covering the name of the teen's cardiac condition, previous cardiac interventions, and name and purpose of the teen's medications. Potential late cardiac complications and contact names and location of local adult CHD cardiologists are also reviewed. Three scenarios regarding adolescent risk taking behaviors (written in the 3rd person) are presented to the teen who will be asked what advice he/she would offer to the teen in each of those scenarios. The teen will be given a study email address and encouraged to contact the APN by email or text messaging with follow-up questions. If no contact is initiated after 1 week, the APN will email or text (based on preference) the youth, to discuss additional questions.
285024|NCT01286480|E2|Reported Event|Usual Care|The youth in the usual care arm see a nurse for vitals. They rely on their cardiologist for information about their heart condition. The approach and amount of time taken by each cardiologist with a youth varies.
285025|NCT01286480|E1|Reported Event|Intervention|This will involve a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. A MyHealth passport will be created covering the name of the teen's cardiac condition, previous cardiac interventions, and name and purpose of the teen's medications. Potential late cardiac complications and contact names and location of local adult CHD cardiologists will also be reviewed. Three scenarios regarding adolescent risk taking behaviors (written in the 3rd person) will be presented to the teen who will be asked what advice he/she would offer to the teen in each of those scenarios. The teen will be given a study email address and encouraged to contact the APN by email or text messaging with follow-up questions. If no contact is initiated after 1 week, the APN will email or text (based on preference) the youth, to discuss additional questions.
285026|NCT01286454|B1|Baseline|Entire Study Population|Includes groups randomized to receive fesoterodine 4 mg IR-BIC fasted first, 10% ER-BIC fasted first, 15% ER-BIC fasted first, 20% ER-BIC fasted first and ER tablets fasted first.
285027|NCT01286454|P11|Participant Flow|Fesoterodine 4 mg 10% ER Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in sixth intervention period. A washout period of approximately 2 weeks was maintained between fifth and sixth intervention period.
285028|NCT01286454|P10|Participant Flow|Fesoterodine 4mg ER Tablet, 20% ER, IR, 15% ER, 10% ER|Single oral dose of fesoterodine 4 mg ER tablet under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
285029|NCT01286454|P9|Participant Flow|Fesoterodine 4mg 20% ER, 15% ER, ER Tablet, 10% ER, IR|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
285030|NCT01286454|P8|Participant Flow|Fesoterodine 4mg 15% ER, 10% ER, 20% ER, IR, ER Tablet|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
285031|NCT01286454|P7|Participant Flow|Fesoterodine 4mg 10% ER, IR, 15% ER, ER Tablet, 20% ER|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
285054|NCT01286454|O2|Outcome|Fesoterodine 4 mg 10% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
285055|NCT01286454|O1|Outcome|Fesoterodine 4 mg IR-BIC Fasted|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
326784|NCT01181011|O2|Outcome|Amlodipine 5mg|
285032|NCT01286454|P6|Participant Flow|Fesoterodine 4mg IR, ER Tablet, 10% ER, 20% ER, 15% ER|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg ER tablet under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
285033|NCT01286454|P5|Participant Flow|Fesoterodine 4mg ER Tablet, IR, 20% ER, 10% ER, 15% ER|Single oral dose of fesoterodine 4 mg ER tablet under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
285034|NCT01286454|P4|Participant Flow|Fesoterodine 4mg 20% ER, ER Tablet, 15% ER, IR, 10% ER|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg ER tablet under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
285035|NCT01286454|P3|Participant Flow|Fesoterodine 4mg 15% ER, 20% ER, 10% ER, ER Tablet, IR|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
285036|NCT01286454|P2|Participant Flow|Fesoterodine 4mg 10% ER, 15% ER, IR, 20% ER, ER Tablet|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in forth intervention period; and single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
285037|NCT01286454|P1|Participant Flow|Fesoterodine 4mg IR, 10% ER, ER Tablet, 15% ER, 20% ER|Single oral dose of fesoterodine 4 milligram (mg) immediate release (IR) beads-in-capsule (BIC) under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 10% coated extended release (ER) BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
285038|NCT01286454|O6|Outcome|Fesoterodine 4 mg 10% ER-BIC Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
285039|NCT01286454|O5|Outcome|Fesoterodine 4 mg ER Tablet Fasted|Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
285040|NCT01286454|O4|Outcome|Fesoterodine 4 mg 20% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
285041|NCT01286454|O3|Outcome|Fesoterodine 4 mg 15% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
285042|NCT01286454|O2|Outcome|Fesoterodine 4 mg 10% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
285043|NCT01286454|O1|Outcome|Fesoterodine 4 mg IR-BIC Fasted|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
285044|NCT01286454|O6|Outcome|Fesoterodine 4 mg 10% ER-BIC Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
285045|NCT01286454|O5|Outcome|Fesoterodine 4 mg ER Tablet Fasted|Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
285046|NCT01286454|O4|Outcome|Fesoterodine 4 mg 20% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
285047|NCT01286454|O3|Outcome|Fesoterodine 4 mg 15% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
285048|NCT01286454|O2|Outcome|Fesoterodine 4 mg 10% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
285049|NCT01286454|O1|Outcome|Fesoterodine 4 mg IR-BIC Fasted|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
285050|NCT01286454|O6|Outcome|Fesoterodine 4 mg 10% ER-BIC Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
285051|NCT01286454|O5|Outcome|Fesoterodine 4 mg ER Tablet Fasted|Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
285052|NCT01286454|O4|Outcome|Fesoterodine 4 mg 20% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
285053|NCT01286454|O3|Outcome|Fesoterodine 4 mg 15% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
285056|NCT01286454|O6|Outcome|Fesoterodine 4 mg 10% ER-BIC Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
285057|NCT01286454|O5|Outcome|Fesoterodine 4 mg ER Tablet Fasted|Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
285058|NCT01286454|O4|Outcome|Fesoterodine 4 mg 20% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
285059|NCT01286454|O3|Outcome|Fesoterodine 4 mg 15% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
285060|NCT01286454|O2|Outcome|Fesoterodine 4 mg 10% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
285061|NCT01286454|O1|Outcome|Fesoterodine 4 mg IR-BIC Fasted|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
285062|NCT01286454|O6|Outcome|Fesoterodine 4 mg 10% ER-BIC Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
285063|NCT01286454|O5|Outcome|Fesoterodine 4 mg ER Tablet Fasted|Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
285064|NCT01286454|O4|Outcome|Fesoterodine 4 mg 20% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
285065|NCT01286454|O3|Outcome|Fesoterodine 4 mg 15% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
285066|NCT01286454|O2|Outcome|Fesoterodine 4 mg 10% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
285067|NCT01286454|O1|Outcome|Fesoterodine 4 mg IR-BIC Fasted|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
285068|NCT01286454|E6|Reported Event|Fesoterodine 4 mg 10% ER-BIC Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
285069|NCT01286454|E5|Reported Event|Fesoterodine 4 mg ER Tablet Fasted|Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
285070|NCT01286454|E4|Reported Event|Fesoterodine 4 mg 20% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
285071|NCT01286454|E3|Reported Event|Fesoterodine 4 mg 15% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
285072|NCT01286454|E2|Reported Event|Fesoterodine 4 mg 10% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
285073|NCT01286454|E1|Reported Event|Fesoterodine 4 mg IR-BIC Fasted|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
285074|NCT01286402|B3|Baseline|Total|Total of all reporting groups
285075|NCT01286402|B2|Baseline|Placebo|"Group receiving placebo~-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
285076|NCT01286402|B1|Baseline|Bupropion SR (Sustained Release)|"Group receiving bupropion SR medication~Bupropion SR: - 150mg, taken orally, taken daily for the 1st 3 days~- 300mg, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
285077|NCT01286402|P2|Participant Flow|Placebo|"Group receiving placebo~-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
285078|NCT01286402|P1|Participant Flow|Bupropion SR (Sustained Release)|"Group receiving bupropion SR medication~Bupropion SR: - 150mg (1 pill), taken orally, taken daily for the 1st 3 days~- 300mg (2 pills), taken orally, taken daily for the rest of the 8 weeks of drug treatment"
285079|NCT01286402|O2|Outcome|Placebo|"Group receiving placebo~-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
285080|NCT01286402|O1|Outcome|Bupropion SR (Sustained Release)|"Group receiving bupropion SR medication~Bupropion SR: - 150mg, taken orally, taken daily for the 1st 3 days~- 300mg, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
285081|NCT01286402|E2|Reported Event|Placebo|"Group receiving placebo~-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
285082|NCT01286402|E1|Reported Event|Bupropion SR (Sustained Release)|"Group receiving bupropion SR medication~Bupropion SR: - 150mg (1 pill), taken orally, taken daily for the 1st 3 days~- 300mg (2 pills), taken orally, taken daily for the rest of the 8 weeks of drug treatment"
285083|NCT01286324|B3|Baseline|Total|Total of all reporting groups
285084|NCT01286324|B2|Baseline|Chamomile High Grade Extract|Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
285085|NCT01286324|B1|Baseline|Placebo Tablet|Contained lactose
285086|NCT01286324|P2|Participant Flow|Chamomile High Grade Extract|Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
285087|NCT01286324|P1|Participant Flow|Placebo Tablet|Contained lactose
285088|NCT01286324|O2|Outcome|Chamomile High Grade Extract|Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
285089|NCT01286324|O1|Outcome|Placebo Tablet|Contained lactose
285090|NCT01286324|O2|Outcome|Chamomile High Grade Extract|Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
285091|NCT01286324|O1|Outcome|Placebo Tablet|Contained lactose
285092|NCT01286324|O2|Outcome|Chamomile High Grade Extract|Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
285093|NCT01286324|O1|Outcome|Placebo Tablet|Contained lactose
285094|NCT01286324|O2|Outcome|Chamomile High Grade Extract|Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
285095|NCT01286324|O1|Outcome|Placebo Tablet|Contained lactose
285096|NCT01286324|O2|Outcome|Chamomile High Grade Extract|Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
285097|NCT01286324|O1|Outcome|Placebo Tablet|Contained lactose
285098|NCT01286324|O2|Outcome|Chamomile High Grade Extract|Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
285099|NCT01286324|O1|Outcome|Placebo Tablet|Contained lactose
285100|NCT01286324|E2|Reported Event|Chamomile High Grade Extract|Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
285101|NCT01286324|E1|Reported Event|Placebo Tablet|Contained lactose
285102|NCT01286311|B3|Baseline|Total|Total of all reporting groups
285103|NCT01286311|B2|Baseline|Control|
285104|NCT01286311|B1|Baseline|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
285105|NCT01286311|P2|Participant Flow|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care. After 9 months, control group physicians were provided with lists of their eligible patients and their risk scores.
285106|NCT01286311|P1|Participant Flow|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
285107|NCT01286311|O2|Outcome|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care.
285108|NCT01286311|O1|Outcome|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
285109|NCT01286311|O2|Outcome|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care.
285110|NCT01286311|O1|Outcome|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
285111|NCT01286311|O2|Outcome|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care.
285112|NCT01286311|O1|Outcome|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
285113|NCT01286311|O2|Outcome|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care.
285114|NCT01286311|O1|Outcome|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
285115|NCT01286311|O2|Outcome|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care.
285116|NCT01286311|O1|Outcome|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
285117|NCT01286311|E2|Reported Event|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care.
285118|NCT01286311|E1|Reported Event|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
285119|NCT01286207|B4|Baseline|Total|Total of all reporting groups
285120|NCT01286207|B3|Baseline|Standard Care|Standard care at onset of migraine attack
285121|NCT01286207|B2|Baseline|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
285122|NCT01286207|B1|Baseline|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
285123|NCT01286207|P3|Participant Flow|Standard Care|Standard care at onset of migraine attack
285124|NCT01286207|P2|Participant Flow|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
285125|NCT01286207|P1|Participant Flow|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
285126|NCT01286207|O3|Outcome|Standard Care|Standard care at onset of migraine attack
285127|NCT01286207|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
285128|NCT01286207|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
285129|NCT01286207|O3|Outcome|Standard Care|Standard care at onset of migraine attack
285130|NCT01286207|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
285131|NCT01286207|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
285132|NCT01286207|O3|Outcome|Standard Care|Standard care at onset of migraine attack
285133|NCT01286207|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
285134|NCT01286207|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
285135|NCT01286207|O3|Outcome|Standard Care|Standard care at onset of migraine attack
285136|NCT01286207|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
285137|NCT01286207|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
285138|NCT01286207|O3|Outcome|Standard Care|Standard care at onset of migraine attack
285139|NCT01286207|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
285140|NCT01286207|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
285141|NCT01286207|E3|Reported Event|Standard Care|Standard care at onset of migraine attack
285142|NCT01286207|E2|Reported Event|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
285143|NCT01286207|E1|Reported Event|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
285144|NCT01286168|B1|Baseline|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
285145|NCT01286168|P1|Participant Flow|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
285146|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
285147|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
285148|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
285149|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
285150|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
285151|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
285152|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
285153|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
285154|NCT01286168|E2|Reported Event|Control Side|"Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site with a cotton swab dipped in rubbing alcohol. The drain exit will be covered with a dry sterile gauze dressing and changed after each episode of drain care.~Control: Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site with a cotton swab dipped in rubbing alcohol. The drain exit will be covered with a dry sterile gauze dressing and changed after each episode of drain care."
285203|NCT01286077|E1|Reported Event|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
285204|NCT01286012|B3|Baseline|Total|Total of all reporting groups
285205|NCT01286012|B2|Baseline|Placebo: Conventional Liquid Bicarbonate|"Control concentrate lacking SFP does not contain SFP (total iron = 0)~Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks."
285262|NCT01285843|P1|Participant Flow|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
285155|NCT01286168|E1|Reported Event|Antisepsis Side|"A chlorhexidine gluconate disk (BioPatch) covered by an occlusive adhesive dressing (Tegaderm) will be applied to the intervention drain sites and changed every three days. The drainage bulb will be irrigated with 10ml of 0.125% sodium hypochlorite (Dakin's solution) twice a day.~Sodium hypochlorite (Dakin's Solution): 10 ml of 0.125% sodium hypochlorite (Dakin's solution) irrigation to the drainage bulb two times a day~Chlorhexidine gluconate disk: Apply one chlorhexidine disk to the intervention drain site(s) and change every three days~Occlusive Adhesive Dressing: A chlorhexidine gluconate disk (BioPatch) covered by an occlusive adhesive dressing (Tegaderm) will be applied to the intervention drain sites and changed every three days."
285156|NCT01286129|B3|Baseline|Total|Total of all reporting groups
285157|NCT01286129|B2|Baseline|Allergic Rhinitic Without Asthma|Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
285158|NCT01286129|B1|Baseline|Allergic Asthmatic|Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
285159|NCT01286129|P2|Participant Flow|Allergic Rhinitic Without Asthma|Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
285160|NCT01286129|P1|Participant Flow|Allergic Asthmatic|Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
285161|NCT01286129|O2|Outcome|Allergic Non Asthmatic|Change in nasal lavage eosinophil percentages in allergic non asthmatic at baseline and at 7h post first and last challenge
285162|NCT01286129|O1|Outcome|Allergic Asthmatic|Change in nasal lavage eosinophil percentages in allergic asthmatic at baseline and at 7h post first and last challenge
285163|NCT01286129|O2|Outcome|Allergic Rhinitic Without Asthma|Variation in sputum eosinophil percentage in allergic non asthmatic between baseline value and at 7h following first and last challenge
285164|NCT01286129|O1|Outcome|Allergic Asthmatic|Variation in sputum eosinophil percentage in allergic asthmatic between baseline value and at 7h following first and last challenge
285165|NCT01286129|E2|Reported Event|Allergic Rhinitic Without Asthma|Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
285166|NCT01286129|E1|Reported Event|Allergic Asthmatic|Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
285167|NCT01286077|B3|Baseline|Total|Total of all reporting groups
285168|NCT01286077|B2|Baseline|Non-treated Control|no treatment, observation only
285169|NCT01286077|B1|Baseline|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
285170|NCT01286077|P2|Participant Flow|Non-treated Control|no treatment, observation only
285171|NCT01286077|P1|Participant Flow|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
285172|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
285173|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
285174|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
285175|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
285176|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
285177|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
285178|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
285179|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
285180|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
285181|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
285182|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
285183|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
285184|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
285185|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
285186|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
285187|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
285188|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
285189|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
285190|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
285191|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
285192|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
285193|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
285194|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
285195|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
285196|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
285197|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
285198|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
285199|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
285200|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
285201|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
285202|NCT01286077|E2|Reported Event|Non-treated Control|no treatment, observation only
285995|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
285206|NCT01286012|B1|Baseline|SFP in Liquid Bicarbonate|Soluble Ferric Pyrophosphate in liquid bicarbonate: Subjects will be randomized in a 1:1 ratio to receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) or conventional solutions lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks.
285207|NCT01286012|P2|Participant Flow|Placebo: Conventional Liquid Bicarbonate|"Control concentrate lacking SFP does not contain SFP (total iron = 0)~Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks."
285208|NCT01286012|P1|Participant Flow|SFP in Liquid Bicarbonate|Soluble Ferric Pyrophosphate in liquid bicarbonate: Subjects will receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) at every dialysis session, for a total duration of 36 weeks.
285209|NCT01286012|O2|Outcome|Placebo: Conventional Liquid Bicarbonate|"Control concentrate lacking SFP does not contain SFP (total iron = 0)~Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks."
285210|NCT01286012|O1|Outcome|SFP in Liquid Bicarbonate|Soluble Ferric Pyrophosphate in liquid bicarbonate: Subjects will be randomized in a 1:1 ratio to receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) or conventional solutions lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks.
285211|NCT01286012|O2|Outcome|Placebo: Conventional Liquid Bicarbonate|"Control concentrate lacking SFP does not contain SFP (total iron = 0)~Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks."
285212|NCT01286012|O1|Outcome|SFP in Liquid Bicarbonate|Soluble Ferric Pyrophosphate in liquid bicarbonate: Subjects will be randomized in a 1:1 ratio to receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) or conventional solutions lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks.
285213|NCT01286012|E2|Reported Event|Placebo: Conventional Liquid Bicarbonate|"Control concentrate lacking SFP does not contain SFP (total iron = 0)~Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks."
285214|NCT01286012|E1|Reported Event|SFP in Liquid Bicarbonate|Soluble Ferric Pyrophosphate in liquid bicarbonate: Subjects will receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) at every dialysis session, for a total duration of 36 weeks.
285215|NCT01285947|B3|Baseline|Total|Total of all reporting groups
285216|NCT01285947|B2|Baseline|Non-Naive Subjects|Subjects who have previously undergone energy-based dermatologic procedures in the past.
285217|NCT01285947|B1|Baseline|Naive Subjects|Subjects who have not previously undergone energy-based dermatologic procedures in the past.
285218|NCT01285947|P2|Participant Flow|Non-Naive Subjects|Subjects who have previously undergone energy-based dermatologic procedures in the past.
285219|NCT01285947|P1|Participant Flow|Naive Subjects|Subjects who have not previously undergone energy-based dermatologic procedures in the past.
285220|NCT01285947|O2|Outcome|Non-Naive Subjects|Subjects who have previously undergone energy-based dermatologic procedures in the past.
285221|NCT01285947|O1|Outcome|Naive Subjects|Subjects who have not previously undergone energy-based dermatologic procedures in the past.
285222|NCT01285947|E2|Reported Event|Non-Naive Subjects|Subjects who have previously undergone energy-based dermatologic procedures in the past.
285223|NCT01285947|E1|Reported Event|Naive Subjects|Subjects who have not previously undergone energy-based dermatologic procedures in the past.
285224|NCT01285908|B1|Baseline|All Study Participants|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or Pure Autonomic Failure.
285225|NCT01285908|P3|Participant Flow|Norepinephrine, Then Saline|Orthostatic hypotension was measured while lying flat (0 degrees) and at varying tilt angles (20, 40, and 60 degrees) under two separate conditions, i.e., first following IV administration of norepinephrine followed by IV administration of saline. Measures included the following: blood pressure (systolic and diastolic), mean arterial pressure, heart rate, cardiac stroke volume, cardiac output, total peripheral resistance, plasma levels of norepinephrine and dihydroxyphenylglycol.
285226|NCT01285908|P2|Participant Flow|Saline, Then Norepinephrine|Orthostatic hypotension was measured while lying flat (0 degrees) and at varying tilt angles (20, 40, and 60 degrees) under two separate conditions, i.e., first following IV administration of saline followed by IV administration of norepinephrine. Measures included the following: blood pressure (systolic and diastolic), mean arterial pressure, heart rate, cardiac stroke volume, cardiac output, total peripheral resistance, plasma levels of norepinephrine and dihydroxyphenylglycol.
285227|NCT01285908|P1|Participant Flow|Baseline|Orthostatic hypotension was measured while lying flat (0 degrees) and at varying tilt angles (20, 40, and 60 degrees). Baseline measures included the following: blood pressure (systolic and diastolic), mean arterial pressure, heart rate, cardiac stroke volume, cardiac output, total peripheral resistance, plasma levels of norepinephrine and dihydroxyphenylglycol.
285228|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of plasma levels of dihydroxyphenylglycol taken at varying tilt angles following a norepinephrine infusion.
285229|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of plasma levels of dihydroxyphenylglycol taken at varying tilt angles following a saline infusion.
285230|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of plasma levels of dihydroxyphenylglycol at varying tilt angles.
285231|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of plasma levels of norepinephrine taken at varying tilt angles following a norepinephrine infusion.
285232|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of plasma levels of norepinephrine taken at varying tilt angles following a saline infusion.
285261|NCT01285843|P2|Participant Flow|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
285233|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of plasma levels of norepinephrine at varying tilt angles.
285234|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of total peripheral resistance taken at varying tilt angles following a norepinephrine infusion.
285235|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of total peripheral resistance taken at varying tilt angles following a saline infusion.
285236|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of total peripheral resistance taken at varying tilt angles.
285237|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of cardiac output taken at varying tilt angles following a norepinephrine infusion.
285238|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of cardiac output taken at varying tilt angles following a saline infusion.
285239|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of cardiac output taken at varying tilt angles.
285240|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of average blood pressure taken at varying tilt angles following a norepinephrine infusion.
285241|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of average blood pressure taken at varying tilt angles following a saline infusion.
285242|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of average blood pressure taken at varying tilt angles.
285243|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of cardiac stroke volume taken at varying tilt angles following a norepinephrine infusion.
285244|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of cardiac stroke volume taken at varying tilt angles following a saline infusion.
285245|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of cardiac stroke volume taken at varying tilt angles.
285246|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of heart rate taken at varying tilt angles following a norepinephrine infusion.
285247|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of heart rate taken at varying tilt angles following a saline infusion.
285248|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of heart rate taken at varying tilt angles.
285249|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a norepinephrine infusion.
285250|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a saline infusion.
285251|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of diastolic blood pressure taken at varying tilt angles.
285252|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a norepinephrine infusion.
285253|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a saline infusion.
285254|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of systolic blood pressure taken at varying tilt angles.
285255|NCT01285908|E3|Reported Event|Norepinephrine, Then Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements taken at varying tilt angles under two separate conditions, i.e., following IV administration of norepinephrine, followed by IV administration of saline.
285256|NCT01285908|E2|Reported Event|Saline, Then Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements taken at varying tilt angles under two separate conditions, i.e., following IV administration of saline, followed by IV administration of norepinephrine.
285257|NCT01285908|E1|Reported Event|Baseline|The participants are patients with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of BP at varying tilt angles.
285258|NCT01285843|B3|Baseline|Total|Total of all reporting groups
285259|NCT01285843|B2|Baseline|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
285260|NCT01285843|B1|Baseline|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
285996|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
285263|NCT01285843|O2|Outcome|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
285264|NCT01285843|O1|Outcome|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
285265|NCT01285843|O2|Outcome|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
285266|NCT01285843|O1|Outcome|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
285267|NCT01285843|O2|Outcome|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
285268|NCT01285843|O1|Outcome|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
285269|NCT01285843|O2|Outcome|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
285270|NCT01285843|O1|Outcome|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
285271|NCT01285843|E2|Reported Event|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
285272|NCT01285843|E1|Reported Event|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
285273|NCT01285791|B4|Baseline|Total|Total of all reporting groups
285274|NCT01285791|B3|Baseline|Patients Undergoing Laparoscopic Gastric Bypass|morbid obese patients undergoing laparoscopic gastric bypass will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
285275|NCT01285791|B2|Baseline|Patients Undergoing Laparoscopic Sleeve Gastrectomy|morbid obese patients undergoing laparoscopic sleeve gastrectomy will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
285276|NCT01285791|B1|Baseline|Patients Undergoing Laparoscopic Adjustable Gastric Banding|morbid obese patients undergoing laparoscopic adjustable gastric banding will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased.
285277|NCT01285791|P3|Participant Flow|Patients Undergoing Laparoscopic Gastric Bypass|morbid obese patients undergoing laparoscopic gastric bypass will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
285278|NCT01285791|P2|Participant Flow|Patients Undergoing Laparoscopic Sleeve Gastrectomy|morbid obese patients undergoing laparoscopic sleeve gastrectomy will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
285279|NCT01285791|P1|Participant Flow|Patients Undergoing Laparoscopic Adjustable Gastric Banding|morbid obese patients undergoing laparoscopic adjustable gastric banding will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased.
285280|NCT01285791|O3|Outcome|Patients Undergoing Laparoscopic Gastric Bypass|morbid obese patients undergoing laparoscopic gastric bypass will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
285281|NCT01285791|O2|Outcome|Patients Undergoing Laparoscopic Sleeve Gastrectomy|morbid obese patients undergoing laparoscopic sleeve gastrectomy will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
285282|NCT01285791|O1|Outcome|Patients Undergoing Laparoscopic Adjustable Gastric Banding|morbid obese patients undergoing laparoscopic adjustable gastric banding will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased.
285283|NCT01285791|E3|Reported Event|Patients Undergoing Laparoscopic Gastric Bypass|morbid obese patients undergoing laparoscopic gastric bypass will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
285284|NCT01285791|E2|Reported Event|Patients Undergoing Laparoscopic Sleeve Gastrectomy|morbid obese patients undergoing laparoscopic sleeve gastrectomy will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
285285|NCT01285791|E1|Reported Event|Patients Undergoing Laparoscopic Adjustable Gastric Banding|morbid obese patients undergoing laparoscopic adjustable gastric banding will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased.
285286|NCT01285713|B3|Baseline|Total|Total of all reporting groups
285287|NCT01285713|B2|Baseline|Normal Saline|10cc/kg NS, followed by 30cc/kg NS
285288|NCT01285713|B1|Baseline|D5Normal Saline|10cc/kg D5NS, followed by 30cc/kg NS
285289|NCT01285713|P2|Participant Flow|Normal Saline (NS)|10cc/kg NS, followed by 30cc/kg NS
285290|NCT01285713|P1|Participant Flow|5% Dextrose (D5) in Normal Saline (NS)|10cc/kg 5% Dextrose (D5) in Normal Saline (NS) (D5NS), followed by 30cc/kg Normal Saline (NS)
285291|NCT01285713|O2|Outcome|Normal Saline|10cc/kg NS, followed by 30cc/kg NS
285292|NCT01285713|O1|Outcome|D5Normal Saline|10cc/kg D5NS, followed by 30cc/kg NS
285293|NCT01285713|E2|Reported Event|Normal Saline|10cc/kg NS, followed by 30cc/kg NS
285294|NCT01285713|E1|Reported Event|D5Normal Saline|10cc/kg D5NS, followed by 30cc/kg NS
285295|NCT01285635|B4|Baseline|Total|Total of all reporting groups
285296|NCT01285635|B3|Baseline|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
285297|NCT01285635|B2|Baseline|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles
285298|NCT01285635|B1|Baseline|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
285299|NCT01285635|P3|Participant Flow|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
285300|NCT01285635|P2|Participant Flow|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
285997|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
285301|NCT01285635|P1|Participant Flow|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
285302|NCT01285635|O3|Outcome|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
285303|NCT01285635|O2|Outcome|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
285304|NCT01285635|O1|Outcome|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
285305|NCT01285635|O3|Outcome|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
285306|NCT01285635|O2|Outcome|Pulse AT-101 Then Metronomic AT-101|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
285307|NCT01285635|O1|Outcome|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
285308|NCT01285635|O3|Outcome|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
285309|NCT01285635|O2|Outcome|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles
285310|NCT01285635|O1|Outcome|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
285311|NCT01285635|O1|Outcome|Docetaxel and AT-101|"Patients all receive Docetaxel 75mg/m^2 on Day 1. Patients will receive AT-101 on one of the following arms:~Arm A: Docetaxel alone for two weeks, then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.~Arm B: AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles~Arm C: AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles."
285312|NCT01285635|O3|Outcome|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
285313|NCT01285635|O2|Outcome|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
285314|NCT01285635|O1|Outcome|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
285315|NCT01285635|E3|Reported Event|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
285316|NCT01285635|E2|Reported Event|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
285317|NCT01285635|E1|Reported Event|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
285318|NCT01285609|B3|Baseline|Total|Total of all reporting groups
285319|NCT01285609|B2|Baseline|Placebo With Paclitaxel/Carboplatin|Placebo + Active Chemo Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
285320|NCT01285609|B1|Baseline|Ipilimumab With Paclitaxel/Carboplatin|Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
285321|NCT01285609|P2|Participant Flow|Placebo With Paclitaxel/Carboplatin|Placebo + Active Chemotherapy Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemotherapy Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
285322|NCT01285609|P1|Participant Flow|Ipilimumab With Paclitaxel/Carboplatin|Ipilimumab + Active Chemotherapy Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
285323|NCT01285609|O2|Outcome|Placebo With Paclitaxel/Carboplatin|Placebo + Active Chemo Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemotherapy Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
285352|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285353|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285354|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
326785|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
285324|NCT01285609|O1|Outcome|Ipilimumab With Paclitaxel/Carboplatin|Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemotherapy Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
285325|NCT01285609|O2|Outcome|Placebo With Paclitaxel/Carboplatin|Placebo + Active Chemo Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
285326|NCT01285609|O1|Outcome|Ipilimumab With Paclitaxel/Carboplatin|Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
285327|NCT01285609|O2|Outcome|Placebo With Paclitaxel/Carboplatin|Placebo + Active Chemo Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
285328|NCT01285609|O1|Outcome|Ipilimumab With Paclitaxel/Carboplatin|Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
285329|NCT01285609|E2|Reported Event|Placebo With Paclitaxel/Carboplatin|Placebo + Active Chemo Backbone Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
285330|NCT01285609|E1|Reported Event|Ipilimumab With Paclitaxel/Carboplatin|Ipilimumab + Active Chemo Backbone Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
285331|NCT01285518|B9|Baseline|Total|Total of all reporting groups
285332|NCT01285518|B8|Baseline|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
285333|NCT01285518|B7|Baseline|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285334|NCT01285518|B6|Baseline|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285335|NCT01285518|B5|Baseline|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285336|NCT01285518|B4|Baseline|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285337|NCT01285518|B3|Baseline|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285338|NCT01285518|B2|Baseline|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285339|NCT01285518|B1|Baseline|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285340|NCT01285518|P8|Participant Flow|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
285341|NCT01285518|P7|Participant Flow|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285342|NCT01285518|P6|Participant Flow|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285343|NCT01285518|P5|Participant Flow|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285344|NCT01285518|P4|Participant Flow|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285345|NCT01285518|P3|Participant Flow|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285346|NCT01285518|P2|Participant Flow|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285347|NCT01285518|P1|Participant Flow|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285348|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285349|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285350|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285351|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285355|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285356|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285357|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285358|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285359|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285360|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285361|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285362|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285363|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285364|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285365|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285366|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285367|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285368|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285369|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285370|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285371|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285372|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285373|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285374|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285375|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285376|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285377|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285378|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285379|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285380|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285381|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285382|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285383|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285384|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285385|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285386|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285387|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285388|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285389|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285390|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285391|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285392|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285393|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285394|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285395|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285396|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285397|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285398|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285399|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285400|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285401|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285402|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285403|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285998|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
285404|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285405|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285406|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
285407|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285408|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285409|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285410|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285411|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285412|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285413|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285414|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
285415|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285416|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285417|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285418|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285419|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285420|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285421|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285422|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
285423|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285424|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285425|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285426|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285427|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285428|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285429|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285430|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
285431|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285432|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285433|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285434|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285435|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285436|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285437|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285438|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
285439|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285440|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285441|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285442|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285443|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285444|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285445|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285446|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
285447|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285448|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285449|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285450|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285451|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285999|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
285452|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285453|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285454|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
285455|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285456|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285457|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285458|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285459|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285460|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285461|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285462|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
285463|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285464|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285465|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285466|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285467|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285468|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285469|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285470|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
285471|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285472|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285473|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285474|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285475|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285476|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285477|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285478|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
285479|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285480|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285481|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285482|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285483|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285484|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285485|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285486|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
285487|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285488|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285489|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285490|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285491|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285492|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285493|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285494|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
285495|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285496|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285497|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285498|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285499|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
326786|NCT01181011|O2|Outcome|Amlodipine 5mg|
285500|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285501|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285502|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
285503|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285504|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285505|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285506|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285507|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285508|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285509|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285510|NCT01285518|O1|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285511|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
285512|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285513|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285514|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285515|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285516|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285517|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285518|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285519|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285520|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285521|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285522|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285523|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285524|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285525|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285526|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285527|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285528|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285529|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285530|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285531|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285532|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285533|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285534|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285535|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285536|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285537|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285538|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285539|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285540|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
285541|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285542|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285543|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285544|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285545|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285546|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285547|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285548|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
285549|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285550|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285551|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285552|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285553|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285554|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285555|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285556|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
285557|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285558|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285559|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285560|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285561|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285562|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285563|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285564|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
285565|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285566|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285567|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285568|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285569|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285570|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285571|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285572|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
285573|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285574|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285575|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285576|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285577|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285578|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285579|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285580|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
285581|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285582|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285583|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285584|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285585|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285586|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285587|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285588|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
285589|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285590|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285591|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285592|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285593|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285594|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285595|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285596|NCT01285518|E8|Reported Event|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
285597|NCT01285518|E7|Reported Event|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
285598|NCT01285518|E6|Reported Event|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
285599|NCT01285518|E5|Reported Event|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
285600|NCT01285518|E4|Reported Event|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
285601|NCT01285518|E3|Reported Event|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
285602|NCT01285518|E2|Reported Event|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
285603|NCT01285518|E1|Reported Event|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
285604|NCT01285492|B3|Baseline|Total|Total of all reporting groups
285605|NCT01285492|B2|Baseline|Tiotropium|tiotropium 18 μg o.d.
285606|NCT01285492|B1|Baseline|QVA149|QVA149 110/50 μg once a day (o.d)
285607|NCT01285492|P2|Participant Flow|Tiotropium|tiotropium 18 μg o.d.
285608|NCT01285492|P1|Participant Flow|QVA149|QVA149 110/50 μg o.d. (once a day)
285609|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
285610|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
285611|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
285612|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
285613|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
285614|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
285615|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
285616|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
285617|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
285618|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
285619|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
285620|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
285621|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
285622|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
285623|NCT01285492|E2|Reported Event|Tiotropium|tiotropium 18 μg o.d.
285624|NCT01285492|E1|Reported Event|QVA149|QVA149 110/50 μg once a day (o.d)
285625|NCT01285427|B1|Baseline|DNA Loci (SeCore vs. SSP UniTray Platforms)|
285626|NCT01285427|P1|Participant Flow|DNA Loci (SeCore vs. SSP UniTray Platforms)|
285627|NCT01285427|O1|Outcome|SeCore® Kit, DR Group Kit (DRB345 Loci)|SeCore® Kit, DR Group Kit (DRB345 Loci),
285628|NCT01285427|O1|Outcome|SeCore® Kit, DR Group Kit (DRB1 Locus)|SeCore® Kit, DR Group Kit (DRB1 Locus),
285629|NCT01285427|O1|Outcome|SeCore® Kit, DRB1 Locus|SeCore® Kit, DRB1 Locus
285630|NCT01285427|O1|Outcome|SeCore® Kit, DQB1 Locus|SeCore® Kit, DQB1 Locus
285631|NCT01285427|O1|Outcome|SeCore® DPB1 Locus Kit|SeCore® DPB1 Locus Kit
285632|NCT01285427|O1|Outcome|SeCore® Kit, C Locus|SeCore® Kit, C Locus
285633|NCT01285427|O1|Outcome|SeCore® Kit, B Locus (Single Amp)|SeCore® Kit, B Locus (Single Amp)
285634|NCT01285427|O1|Outcome|Concordance|SeCore kit, A Locus
285635|NCT01285427|O1|Outcome|Concordance|All SeCore Kits
285636|NCT01285427|E1|Reported Event|Concordance|All SeCore Kits
285637|NCT01285401|B3|Baseline|Total|Total of all reporting groups
285638|NCT01285401|B2|Baseline|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
285639|NCT01285401|B1|Baseline|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
285640|NCT01285401|P2|Participant Flow|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
285641|NCT01285401|P1|Participant Flow|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25-hydroxyvitamin D [25(OH)D3] serum levels below 150 nano mol per liter (nmol/L) received Vigantol oil 6,670 international unit per day (IU/d) [167 microgram per day (mcg/d)] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous three times a week (tiw).
285642|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
285643|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
285644|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
285645|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
285646|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
285647|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
285648|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
285781|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
286000|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
285649|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
285650|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
285651|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
285652|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
285653|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
285654|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
285655|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
285656|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
285657|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
285658|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
285659|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
285660|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
285661|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
285662|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
285663|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
285664|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
285665|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
285666|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
285667|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
285668|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
285669|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
285670|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
285671|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
285672|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
285673|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
285674|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
285675|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
285676|NCT01285401|E2|Reported Event|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
285825|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285677|NCT01285401|E1|Reported Event|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
285678|NCT01285323|B3|Baseline|Total|Total of all reporting groups
285679|NCT01285323|B2|Baseline|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285680|NCT01285323|B1|Baseline|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285681|NCT01285323|P2|Participant Flow|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285682|NCT01285323|P1|Participant Flow|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285683|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285684|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285685|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285686|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285687|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285688|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285689|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285690|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285691|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285692|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285693|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285694|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285695|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285696|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285697|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285698|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285699|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285700|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285701|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285702|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285703|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285704|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285705|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285706|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285707|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285708|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285709|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285710|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285711|NCT01285323|E2|Reported Event|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285712|NCT01285323|E1|Reported Event|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
285713|NCT01285310|B4|Baseline|Total|Total of all reporting groups
285714|NCT01285310|B3|Baseline|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase and continued 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
285715|NCT01285310|B2|Baseline|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase and continued 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
285716|NCT01285310|B1|Baseline|Placebo|Placebo: Oral Placebo tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in active treatment / active treatment extension phase. Participants who are nonresponders were transitioned early to 20 mg Apremilast BID at Week 16.
285717|NCT01285310|P5|Participant Flow|Placebo / Apremilast 20 mg XO|"Participants initially randomized to receive placebo twice daily who were transitioned at Week 24 (XO) to receive 20 mg apremilast for up to Week 52.~At week 52, they were given the option to remain on active treatment for 1 additional year (extension phase) as assigned during the active treatment phase."
285741|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
285718|NCT01285310|P4|Participant Flow|Placebo/Apremilast 20mg EE|"Participants initially randomized to receive placebo twice daily and were transitioned due to early escape (EE) at Week 16 to receive 20 mg apremilast for up to week 24.~At week 24, participants were continued on Apremilast 20 mg BID for up to Week 52.~At week 52, they were given the option to remain on active treatment for 1 additional year (extension phase) as assigned during the active treatment phase."
285719|NCT01285310|P3|Participant Flow|Apremilast 30 mg|"Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 30 mg apremilast tablets twice daily (BID) for up to Week 52 in the active treatment.~At week 52, participants were given the option to remain on active treatment for 1 additional year (extension phase) as assigned during the active treatment phase."
285720|NCT01285310|P2|Participant Flow|Apremilast 20 mg|"Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 20 mg apremilast tablets twice daily (BID) for up to Week 52 in the active treatment.~At week 52, participants were given the option to remain on active treatment for 1 additional year (extension phase) as assigned during the active treatment phase."
285721|NCT01285310|P1|Participant Flow|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg Apremilast twice daily (early escape), and were designated as Placebo/Apremilast 20mg EE.
285722|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
285723|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
285724|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
285725|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
285726|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
285727|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
285728|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
285729|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
285730|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
285731|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
285732|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
285733|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
285734|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
285735|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
285736|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
285737|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
285738|NCT01285310|O2|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285739|NCT01285310|O1|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285740|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
285780|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285742|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
285743|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
285744|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
285745|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
285746|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
285747|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
285748|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285749|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285750|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
285751|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
285752|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285753|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285754|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
285755|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
285756|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285757|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285758|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
285759|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
285760|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285761|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285762|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|.Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
285763|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
285764|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285765|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285766|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily
285767|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
285768|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285769|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285770|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
285771|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
285772|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285773|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285774|NCT01285310|O2|Outcome|Placebo / Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
285775|NCT01285310|O1|Outcome|Placebo/Apremilast 20 EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
285776|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285777|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285778|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
285779|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
326787|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
285782|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
285783|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
285784|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285785|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285786|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
285787|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
285788|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285789|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285790|NCT01285310|O2|Outcome|Placebo / Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
285791|NCT01285310|O1|Outcome|Placebo/Apremilast 20 EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
285792|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285793|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285794|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
285795|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
285796|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285797|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285798|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
285799|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
285800|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285801|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285802|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
285803|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
285804|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285805|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285806|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
285807|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
285808|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285809|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285810|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
285811|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
285812|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285813|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285814|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
285815|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
285816|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285817|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285818|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
285819|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
285820|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285821|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285822|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned transitioned to receive 20 mg apremilast twice daily.
285823|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
285824|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285826|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
285827|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
285828|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285829|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285830|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned to 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
285831|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
285832|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
285833|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
285834|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285835|NCT01285310|O2|Outcome|Apremilast 20 mg|.Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285836|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
285837|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285838|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285839|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned to 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
285840|NCT01285310|O3|Outcome|Apremilast 30 mg|.Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285841|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285842|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
285843|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285844|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285845|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
285846|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285847|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285848|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape)and were designated as Placebo/Apremilast 20mg EE.
285849|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
285850|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285851|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
285852|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
285853|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285854|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
285855|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285856|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285857|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
285858|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
285859|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
285860|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
285861|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
285983|NCT01284959|B3|Baseline|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
285862|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
285863|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
285864|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
285865|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
285866|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE .
285867|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285868|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285869|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
285870|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
285871|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
285872|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
285873|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285874|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285875|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE ..
285876|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
285877|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
285878|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
285879|NCT01285310|O3|Outcome|Apremilast 30 mg|.Participants initially randomized to receive 30 mg apremilast tablets twice daily
285880|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
285881|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
285882|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
285883|NCT01285310|O2|Outcome|Apremilast 20 mg|.Participants initially randomized to receive 20 mg apremilast tablets twice daily
285884|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape).
285885|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
285886|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285887|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
285888|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285889|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285890|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
285891|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
285892|NCT01285310|O2|Outcome|Apremilast 20 mg|.Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285893|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
285894|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285895|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285896|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
285897|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285898|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285899|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily
285900|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
285901|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285902|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
285903|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285904|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285905|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
285906|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
285907|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285908|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
285909|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285910|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285911|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
285912|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285913|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285914|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
285915|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285916|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285917|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
285918|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
285919|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285920|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
285921|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285922|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285923|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
285924|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
285925|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285926|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
285927|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285928|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285929|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
285930|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285931|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285932|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
285933|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285934|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285935|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
285936|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285937|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285938|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE
285939|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
285940|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
285941|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
285942|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285943|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285944|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
285945|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
285946|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
285947|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
285948|NCT01285310|E5|Reported Event|Study Termination: Apremilast 30 mg|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Study Termination.
285949|NCT01285310|E4|Reported Event|Study Termination: Apremilast 20 mg|Participants who received 20 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Study Termination.
285950|NCT01285310|E3|Reported Event|Week 24: Apremilast 30 mg|Participants randomized to receive 30 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
285951|NCT01285310|E2|Reported Event|Week 24: Apremilast 20 mg|Participants randomized to receive 20 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
285984|NCT01284959|B2|Baseline|Placebo|drug: lactose group: placebo
285952|NCT01285310|E1|Reported Event|Week 24: Placebo|Participants randomized to placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for participants who escaped early, and through Week 24 for all other participants.
285953|NCT01285076|B1|Baseline|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
285954|NCT01285076|P1|Participant Flow|All Enrolled Participants|Adults with Type 2 diabetes mellitus (DM) ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU + metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
285955|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
285956|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
285957|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
285958|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
285959|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
285960|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
285961|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
285962|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
285963|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
285964|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
285965|NCT01285076|E1|Reported Event|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
285966|NCT01285050|B1|Baseline|Pre Post ART|"HCV and HIV viral load pre and post antiretroviral therapy~Anti-HIV Agents: Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.~raltegravir: HIV medication, 400 mg twice daily by mouth~Emtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth"
285967|NCT01285050|P1|Participant Flow|Pre Post ART|"HCV and HIV viral load pre and post antiretroviral therapy~Anti-HIV Agents: Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.~raltegravir: HIV medication, 400 mg twice daily by mouth~Emtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth"
285968|NCT01285050|O2|Outcome|Post ART HCV Decline|HCV RNA determined by RT-PCR and expressed as log IU/ml after ART
285969|NCT01285050|O1|Outcome|Pre ART HCV RNA Decline|"HCV viral load determined by RT-PCR and reported as log IU/ml before giving antiretroviral therapy (ART)~Interferon alfa-2b was administered once as part of a pharmacokinetic study before and after ART.~ART included:~raltegravir: HIV medication, 400 mg twice daily by mouth~Emtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth"
285970|NCT01285050|E1|Reported Event|Pre Post ART|"HCV and HIV viral load pre and post antiretroviral therapy~Anti-HIV Agents: Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.~raltegravir: HIV medication, 400 mg twice daily by mouth~Emtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth"
285971|NCT01285024|B3|Baseline|Total|Total of all reporting groups
285972|NCT01285024|B2|Baseline|Vitagel|"Vitagel applied just prior to closure during total hip arthroplasty~Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule."
285973|NCT01285024|B1|Baseline|Control|No Vitagel used during total hip arthroplasty
285974|NCT01285024|P2|Participant Flow|Vitagel|"Vitagel applied just prior to closure during total hip arthroplasty~Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule."
285975|NCT01285024|P1|Participant Flow|Control|No Vitagel used during total hip arthroplasty
285976|NCT01285024|O2|Outcome|Vitagel|"Vitagel applied just prior to closure during total hip arthroplasty~Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule."
285977|NCT01285024|O1|Outcome|Control|No Vitagel used during total hip arthroplasty
285978|NCT01285024|O2|Outcome|Vitagel|"Vitagel applied just prior to closure during total hip arthroplasty~Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule."
285979|NCT01285024|O1|Outcome|Control|No Vitagel used during total hip arthroplasty
285980|NCT01285024|E2|Reported Event|Vitagel|"Vitagel applied just prior to closure during total hip arthroplasty~Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule."
285981|NCT01285024|E1|Reported Event|Control|No Vitagel used during total hip arthroplasty
285982|NCT01284959|B4|Baseline|Total|Total of all reporting groups
286001|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
286002|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
286003|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
286004|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
286005|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
286006|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
286007|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
286008|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
286009|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
286010|NCT01284959|E3|Reported Event|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
286011|NCT01284959|E2|Reported Event|Placebo|drug: lactose group: placebo
286012|NCT01284959|E1|Reported Event|Risperidone|Drug: risperidone Groups: risperidone
286013|NCT01284634|B5|Baseline|Total|Total of all reporting groups
286014|NCT01284634|B4|Baseline|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286015|NCT01284634|B3|Baseline|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes for the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003 per day.
286016|NCT01284634|B2|Baseline|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes for the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003 per day.
286017|NCT01284634|B1|Baseline|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first 30 minutes before breakfast [fasted] and the second 30 minutes for the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003 per day.
286018|NCT01284634|P4|Participant Flow|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286019|NCT01284634|P3|Participant Flow|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286020|NCT01284634|P2|Participant Flow|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286021|NCT01284634|P1|Participant Flow|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286022|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286023|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286024|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286025|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286026|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286027|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286028|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286029|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286030|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286031|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286466|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
286032|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286033|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286034|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286035|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286036|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286037|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286038|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286039|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286040|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286041|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286042|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286043|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286044|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286045|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286046|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286047|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286048|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286049|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286050|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286051|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286052|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286053|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286201|NCT01284621|O1|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286054|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286055|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286056|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286057|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286058|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286059|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286060|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286061|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286062|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286063|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286064|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286065|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286066|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286067|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286068|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286069|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286070|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286071|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286072|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286073|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286074|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286075|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286467|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
286076|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286077|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286078|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286079|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286080|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286081|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286082|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286083|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286084|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286085|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286086|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286087|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286088|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286089|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286090|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286091|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286092|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286093|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286094|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286095|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286096|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286097|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286297|NCT01284062|P3|Participant Flow|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286098|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286099|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286100|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286101|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286102|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286103|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286104|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286105|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286106|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286107|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286108|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286109|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286110|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286111|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286112|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286113|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286114|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286115|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286116|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286117|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286118|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286119|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286772|NCT01282229|O4|Outcome|Coronal Debridement|Quadrant treated with coronal debridement
286120|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286121|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286122|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286123|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286124|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286125|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286126|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286127|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286128|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286129|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286130|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286131|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286132|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003 .
286133|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286134|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286135|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286136|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286137|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286138|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286139|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286140|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286141|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286298|NCT01284062|P2|Participant Flow|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286142|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286143|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286144|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286145|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286146|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286147|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286148|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286149|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286150|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286151|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003 .
286152|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286153|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286154|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286155|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
286156|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
286157|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
286158|NCT01284634|E4|Reported Event|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
286159|NCT01284634|E3|Reported Event|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003 per day.
286160|NCT01284634|E2|Reported Event|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003 per day.
286161|NCT01284634|E1|Reported Event|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first 30 minutes before breakfast [fasted] and the second 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003 per day.
286162|NCT01284621|B1|Baseline|Study Overall|"A randomised, open-label, three period, crossover study. The three treatments administered were~Empagliflozin alone~Ramipril~Empagliflozin plus Ramipril~Each treatment period was 8 days, with drug administration on days 1 to 5, and they were separated by a washout period of at least 7 days between drug administrations of 2 subsequent treatments."
286163|NCT01284621|P6|Participant Flow|Empa + Ramipril / Ramipril Alone / Empa Alone|"Patients were administered three treatments in the following order:~Empagliflozin plus Ramipril~Ramipril~Empagliflozin alone"
286299|NCT01284062|P1|Participant Flow|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286164|NCT01284621|P5|Participant Flow|Empa + Ramipril / Empa Alone / Ramipril Alone|"Patients were administered three treatments in the following order:~Empagliflozin plus Ramipril~Empagliflozin alone~Ramipril"
286165|NCT01284621|P4|Participant Flow|Ramipril Alone / Empa + Ramipril / Empa Alone|"Patients were administered three treatments in the following order:~Ramipril~Empagliflozin plus Ramipril~Empagliflozin alone"
286166|NCT01284621|P3|Participant Flow|Ramipril Alone / Empa Alone / Empa + Ramipril|"Patients were administered three treatments in the following order:~Ramipril~Empagliflozin alone~Empagliflozin plus Ramipril"
286167|NCT01284621|P2|Participant Flow|Empa Alone / Ramipril Alone / Empa + Ramipril|"Patients were administered three treatments in the following order:~Empagliflozin alone~Ramipril~Empagliflozin plus Ramipril"
286168|NCT01284621|P1|Participant Flow|Empa Alone / Empa + Ramipril / Ramipril Alone|"Patients were administered three treatments in the following order:~Empagliflozin alone~Empagliflozin plus Ramipril~Ramipril"
286169|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286170|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286171|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
286172|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286173|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286174|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
286175|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286176|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286177|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
286178|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286179|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286180|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
286181|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286182|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286183|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
286184|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286185|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286186|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
286187|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286188|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286189|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
286190|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286191|NCT01284621|O1|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286192|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286193|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
286194|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286195|NCT01284621|O1|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286196|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286197|NCT01284621|O1|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286198|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286199|NCT01284621|O1|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286200|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286202|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286203|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
286204|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286205|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
286206|NCT01284621|E3|Reported Event|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286207|NCT01284621|E2|Reported Event|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
286208|NCT01284621|E1|Reported Event|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
286209|NCT01284517|B3|Baseline|Total|Total of all reporting groups
286210|NCT01284517|B2|Baseline|Placebo + Li/VPA|
286211|NCT01284517|B1|Baseline|Lurasidone 20-120 mg Flexible Dose+Li/VPA|
286212|NCT01284517|P2|Participant Flow|Placebo + Li/VPA|Placebo + Lithium/divalproex
286213|NCT01284517|P1|Participant Flow|Lurasidone 20-120 mg Flexible Dose+Li/VPA|Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
286214|NCT01284517|O2|Outcome|Placebo + Li/VPA|Placebo (PO) + Lithium or divalproex
286215|NCT01284517|O1|Outcome|Lurasidone 20-120 mg Flexible Dose+Li/VPA|Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
286216|NCT01284517|O2|Outcome|Placebo + Li/VPA|Placebo (PO) + Lithium or divalproex
286217|NCT01284517|O1|Outcome|Lurasidone 20-120 mg Flexible Dose+Li/VPA|Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
286218|NCT01284517|O2|Outcome|Placebo + Li/VPA|Placebo (PO) + Lithium or divalproex
286219|NCT01284517|O1|Outcome|Lurasidone 20-120 mg Flexible Dose+Li/VPA|Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
286220|NCT01284517|E2|Reported Event|Placebo + Li/VPA|Placebo (PO)+ Lithium/divalproex
286221|NCT01284517|E1|Reported Event|Lurasidone 20-120 mg Flexible Dose+Li/VPA|Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
286222|NCT01284504|B3|Baseline|Total|Total of all reporting groups
286223|NCT01284504|B2|Baseline|Placebo|"placebo, tab~placebo: Placebo, tab"
286224|NCT01284504|B1|Baseline|Celecoxib|"Celecoxib, 200 mg tab~Celecoxib: 200 mg tablet oral"
286225|NCT01284504|P2|Participant Flow|Placebo|"placebo~placebo"
286226|NCT01284504|P1|Participant Flow|Celocoxib|Celecoxib: 200 mg tablet oral
286227|NCT01284504|O2|Outcome|Placebo|"placebo~placebo"
286228|NCT01284504|O1|Outcome|Celocoxib|Celecoxib: 200 mg tablet oral
286229|NCT01284504|O2|Outcome|Placebo|"placebo~placebo"
286230|NCT01284504|O1|Outcome|Celocoxib|Celecoxib: 200 mg tablet oral
286231|NCT01284504|O2|Outcome|Placebo|"placebo~placebo"
286232|NCT01284504|O1|Outcome|Celocoxib|Celecoxib: 200 mg tablet oral
286233|NCT01284504|E2|Reported Event|Placebo|"placebo, tab~placebo: Placebo, tab"
286234|NCT01284504|E1|Reported Event|Celecoxib|"Celecoxib, 200 mg tab~Celecoxib: 200 mg tablet oral"
286235|NCT01284491|B1|Baseline|Total Study Population|
286236|NCT01284491|P1|Participant Flow|Total Study Population|
286237|NCT01284491|O2|Outcome|Traditional Electrosurgery With Scalpel|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
286238|NCT01284491|O1|Outcome|PEAK PlasmaBlade 4.0|The PEAK PlasmaBlade will be used for the entirety of the operation, including the skin incision.
286239|NCT01284491|E2|Reported Event|Traditional Electrosurgery With Scalpel|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
286240|NCT01284491|E1|Reported Event|PEAK PlasmaBlade 4.0|The PEAK PlasmaBlade will be used for the entirety of the operation, including the skin incision.
286241|NCT01284426|B1|Baseline|Chronic Urticaria|Chronic urticaria, Natural history
286242|NCT01284426|P1|Participant Flow|Chronic Urticaria|Chronic urticaria, Natural history
286243|NCT01284426|O1|Outcome|Chronic Urticaria|Chronic urticaria, Natural history
286244|NCT01284426|E1|Reported Event|Chronic Urticaria|Chronic urticaria, Natural history
286245|NCT01284361|B1|Baseline|Control and Test Crossover|test and control intermittent urinary catheters : randomized cross-over
286246|NCT01284361|P1|Participant Flow|Control and Test Crossover|test and control intermittent urinary catheters : randomized cross-over
286247|NCT01284361|O2|Outcome|Test 30 cm Catheter|Test gel lubricated 30 cm catheter identical in all aspects to Control catheter except being 10 cm shorter
286248|NCT01284361|O1|Outcome|Control 40 cm Catheter|Commercial gel lubricated 40 cm catheter
286249|NCT01284361|O1|Outcome|Control and Test Crossover|Control and test intermittent urinary catheters : randomized cross-over
286250|NCT01284361|E2|Reported Event|Test 30 cm Catheter|Test 30 cm gel lubricated cather similar in all aspects except 10 cm shorter length as control catheter
286251|NCT01284361|E1|Reported Event|Control 40 cm Catheter|Commercial 40 cm gel lubricated catheter
286252|NCT01284296|B1|Baseline|Digital Block|The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss.
286253|NCT01284296|P1|Participant Flow|Digital Block|The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss.
286254|NCT01284296|O2|Outcome|Digital Block (Perfusion Indices >2.0)|The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss. This is a subgroup of differences with the perfusion index >2.0
286300|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286255|NCT01284296|O1|Outcome|Digital Block (All Perfusion Indices 0.29-8.3)|The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss.
286256|NCT01284296|E1|Reported Event|Digital Block|The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss.
286257|NCT01284244|B3|Baseline|Total|Total of all reporting groups
286258|NCT01284244|B2|Baseline|Silastic Vaginal Ring|Silastic ring: The silastic ring is a plastic flexible ring similar to that used to administer vaginal estrogen (Estring). It is well tolerated and would not contain any medications. Immediately before performing the pad test, it would be placed high in the vagina, away from the urethra. It would be removed immediately after the pad test. Draping will conceal from the patient which device was inserted.
286259|NCT01284244|B1|Baseline|Uresta|Uresta pessary: Participants randomized to the Uresta group will be fitted with device before immediately before performing the pad test. The Uresta pessary is made of medical grade rubber that has been extensively tested for safety. It is bell-shaped, with a narrow tip that allows for easy insertion into the vagina in a similar fashion to a tampon. The device can be easily inserted, and removed by a patient for use when needed. The Uresta comes in 3 sizes. Fitting starts with insertion of the smallest size. If urine leakage continues with valsalva or a cough stress test, it can be replaced by one size larger, until leakage is stopped. If the device prevents the patient from being able to void or is uncomfortable due to its size, the smaller size is replaced. Following the pad test, the participant will be given the opportunity to keep the device for continued use, or remove it if desired.
286260|NCT01284244|P2|Participant Flow|Silastic Vaginal Ring|Silastic ring: The silastic ring is a plastic flexible ring similar to that used to administer vaginal estrogen (Estring). It is well tolerated and would not contain any medications. Immediately before performing the pad test, it would be placed high in the vagina, away from the urethra. It would be removed immediately after the pad test. Draping will conceal from the patient which device was inserted.
286261|NCT01284244|P1|Participant Flow|Uresta|Uresta pessary: Participants randomized to the Uresta group will be fitted with device before immediately before performing the pad test. The Uresta pessary is made of medical grade rubber that has been extensively tested for safety. It is bell-shaped, with a narrow tip that allows for easy insertion into the vagina in a similar fashion to a tampon. The device can be easily inserted, and removed by a patient for use when needed. The Uresta comes in 3 sizes. Fitting starts with insertion of the smallest size. If urine leakage continues with valsalva or a cough stress test, it can be replaced by one size larger, until leakage is stopped. If the device prevents the patient from being able to void or is uncomfortable due to its size, the smaller size is replaced. Following the pad test, the participant will be given the opportunity to keep the device for continued use, or remove it if desired.
286262|NCT01284244|O2|Outcome|Silastic Vaginal Ring|Silastic ring: The silastic ring is a plastic flexible ring similar to that used to administer vaginal estrogen (Estring). It is well tolerated and would not contain any medications. Immediately before performing the pad test, it would be placed high in the vagina, away from the urethra. It would be removed immediately after the pad test. Draping will conceal from the patient which device was inserted.
286263|NCT01284244|O1|Outcome|Uresta|Uresta pessary: Participants randomized to the Uresta group will be fitted with device before immediately before performing the pad test. The Uresta pessary is made of medical grade rubber that has been extensively tested for safety. It is bell-shaped, with a narrow tip that allows for easy insertion into the vagina in a similar fashion to a tampon. The device can be easily inserted, and removed by a patient for use when needed. The Uresta comes in 3 sizes. Fitting starts with insertion of the smallest size. If urine leakage continues with valsalva or a cough stress test, it can be replaced by one size larger, until leakage is stopped. If the device prevents the patient from being able to void or is uncomfortable due to its size, the smaller size is replaced. Following the pad test, the participant will be given the opportunity to keep the device for continued use, or remove it if desired.
286264|NCT01284244|E2|Reported Event|Silastic Vaginal Ring|Silastic ring: The silastic ring is a plastic flexible ring similar to that used to administer vaginal estrogen (Estring). It is well tolerated and would not contain any medications. Immediately before performing the pad test, it would be placed high in the vagina, away from the urethra. It would be removed immediately after the pad test. Draping will conceal from the patient which device was inserted.
286265|NCT01284244|E1|Reported Event|Uresta|Uresta pessary: Participants randomized to the Uresta group will be fitted with device before immediately before performing the pad test. The Uresta pessary is made of medical grade rubber that has been extensively tested for safety. It is bell-shaped, with a narrow tip that allows for easy insertion into the vagina in a similar fashion to a tampon. The device can be easily inserted, and removed by a patient for use when needed. The Uresta comes in 3 sizes. Fitting starts with insertion of the smallest size. If urine leakage continues with valsalva or a cough stress test, it can be replaced by one size larger, until leakage is stopped. If the device prevents the patient from being able to void or is uncomfortable due to its size, the smaller size is replaced. Following the pad test, the participant will be given the opportunity to keep the device for continued use, or remove it if desired.
286266|NCT01284140|B3|Baseline|Total|Total of all reporting groups
286267|NCT01284140|B2|Baseline|Usual Care|"Behavioral: usual care.~Usual care: Usual care."
286268|NCT01284140|B1|Baseline|Sleep Promotion Protocol|"Behavioral: sleep and circadian rhythm promotion including timed light exposure.~Sleep and circadian rhythm promotion: This multifaceted intervention will attempt to enhance sleep and circadian rhythmicity through improved scheduling of nursing procedures, enforcement of a day/night routine, increased light exposure during the day, and decreased light and sound exposure during the night. Supplemental bright lights and eyeshades and noise cancelling headphones may also be employed."
286269|NCT01284140|P2|Participant Flow|Usual Care|"Behavioral: 48 hours of usual care.~Usual care: Usual care."
286301|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286302|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286303|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286270|NCT01284140|P1|Participant Flow|Sleep Promotion Protocol|"Behavioral: 48 hours of sleep and circadian rhythm promotion including timed light exposure.~Sleep and circadian rhythm promotion: This multifaceted intervention attempts to enhance sleep and circadian rhythmicity through improved scheduling of nursing procedures, enforcement of a day/night routine, increased light exposure during the day, and decreased light and sound exposure during the night. The intervention began the morning after enrollment and enforced a specific period of enhanced light exposure from 9:00 a.m. to noon. The initial target of 5,000 lux administered by light box (Sunsation, SunBox Co.) was reduced to 400-700 lux after the first 10 subjects were enrolled in the study."
286271|NCT01284140|O2|Outcome|Usual Care|"Behavioral: 48 hours of usual care.~Usual care: Usual care."
286272|NCT01284140|O1|Outcome|Sleep Promotion Protocol|"Behavioral: 48 hours of sleep and circadian rhythm promotion including timed light exposure.~Sleep and circadian rhythm promotion: This multifaceted intervention attempts to enhance sleep and circadian rhythmicity through improved scheduling of nursing procedures, enforcement of a day/night routine, increased light exposure during the day, and decreased light and sound exposure during the night. The intervention began the morning after enrollment and enforced a specific period of enhanced light exposure from 9:00 a.m. to noon. The initial target of 5,000 lux administered by light box (Sunsation, SunBox Co.) was reduced to 400-700 lux after the first 10 subjects were enrolled in the study."
286273|NCT01284140|O2|Outcome|Usual Care|"Behavioral: 48 hours of usual care.~Usual care: Usual care."
286274|NCT01284140|O1|Outcome|Sleep Promotion Protocol|"Behavioral: 48 hours of sleep and circadian rhythm promotion including timed light exposure.~Sleep and circadian rhythm promotion: This multifaceted intervention attempts to enhance sleep and circadian rhythmicity through improved scheduling of nursing procedures, enforcement of a day/night routine, increased light exposure during the day, and decreased light and sound exposure during the night. The intervention began the morning after enrollment and enforced a specific period of enhanced light exposure from 9:00 a.m. to noon. The initial target of 5,000 lux administered by light box (Sunsation, SunBox Co.) was reduced to 400-700 lux after the first 10 subjects were enrolled in the study."
286275|NCT01284140|O2|Outcome|Usual Care|"Behavioral: 48 hours of usual care.~Usual care: Usual care."
286276|NCT01284140|O1|Outcome|Sleep Promotion Protocol|"Behavioral: 48 hours of sleep and circadian rhythm promotion including timed light exposure.~Sleep and circadian rhythm promotion: This multifaceted intervention attempts to enhance sleep and circadian rhythmicity through improved scheduling of nursing procedures, enforcement of a day/night routine, increased light exposure during the day, and decreased light and sound exposure during the night. The intervention began the morning after enrollment and enforced a specific period of enhanced light exposure from 9:00 a.m. to noon. The initial target of 5,000 lux administered by light box (Sunsation, SunBox Co.) was reduced to 400-700 lux after the first 10 subjects were enrolled in the study."
286277|NCT01284140|O2|Outcome|Usual Care|"Behavioral: 48 hours of usual care.~Usual care: Usual care."
286278|NCT01284140|O1|Outcome|Sleep Promotion Protocol|"Behavioral: 48 hours of sleep and circadian rhythm promotion including timed light exposure.~Sleep and circadian rhythm promotion: This multifaceted intervention attempts to enhance sleep and circadian rhythmicity through improved scheduling of nursing procedures, enforcement of a day/night routine, increased light exposure during the day, and decreased light and sound exposure during the night. The intervention began the morning after enrollment and enforced a specific period of enhanced light exposure from 9:00 a.m. to noon. The initial target of 5,000 lux administered by light box (Sunsation, SunBox Co.) was reduced to 400-700 lux after the first 10 subjects were enrolled in the study."
286279|NCT01284140|O2|Outcome|Usual Care|"Behavioral: 48 hours of usual care.~Usual care: Usual care."
286280|NCT01284140|O1|Outcome|Sleep Promotion Protocol|"Behavioral: 48 hours of sleep and circadian rhythm promotion including timed light exposure.~Sleep and circadian rhythm promotion: This multifaceted intervention attempts to enhance sleep and circadian rhythmicity through improved scheduling of nursing procedures, enforcement of a day/night routine, increased light exposure during the day, and decreased light and sound exposure during the night. The intervention began the morning after enrollment and enforced a specific period of enhanced light exposure from 9:00 a.m. to noon. The initial target of 5,000 lux administered by light box (Sunsation, SunBox Co.) was reduced to 400-700 lux after the first 10 subjects were enrolled in the study."
286281|NCT01284140|E2|Reported Event|Usual Care|"Behavioral: 48 hours of usual care.~Usual care: Usual care."
286282|NCT01284140|E1|Reported Event|Sleep Promotion Protocol|"Behavioral: 48 hours of sleep and circadian rhythm promotion including timed light exposure.~Sleep and circadian rhythm promotion: This multifaceted intervention attempts to enhance sleep and circadian rhythmicity through improved scheduling of nursing procedures, enforcement of a day/night routine, increased light exposure during the day, and decreased light and sound exposure during the night. The intervention began the morning after enrollment and enforced a specific period of enhanced light exposure from 9:00 a.m. to noon. The initial target of 5,000 lux administered by light box (Sunsation, SunBox Co.) was reduced to 400-700 lux after the first 10 subjects were enrolled in the study."
286283|NCT01284114|B1|Baseline|Aliskiren|
286284|NCT01284114|P1|Participant Flow|Aliskiren|Aliskiren: This group recived aliskiren at 150mg orally in the morning once daily
286285|NCT01284114|O1|Outcome|Aliskiren|
286286|NCT01284114|O1|Outcome|Aliskiren|Aliskiren: This group recived aliskiren at 150mg orally in the morning once daily
286287|NCT01284114|O1|Outcome|Aliskiren|Aliskiren: This group recived aliskiren at 150mg orally in the morning once daily
286288|NCT01284114|O1|Outcome|Aliskiren|
286289|NCT01284114|O1|Outcome|Aliskiren|
286290|NCT01284114|E1|Reported Event|Aliskiren|
286291|NCT01284062|B5|Baseline|Total|Total of all reporting groups
286292|NCT01284062|B4|Baseline|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286293|NCT01284062|B3|Baseline|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286294|NCT01284062|B2|Baseline|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286295|NCT01284062|B1|Baseline|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286296|NCT01284062|P4|Participant Flow|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286304|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286305|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286306|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286307|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286308|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286309|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286310|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286311|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286312|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286313|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286314|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286315|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286316|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286317|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286318|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286319|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286320|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286321|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286322|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286323|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286324|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286325|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286326|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286327|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286328|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286329|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286330|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286331|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286332|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286333|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286334|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286335|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286336|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286337|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286338|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286339|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286340|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286341|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286342|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286343|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286344|NCT01284062|O3|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286345|NCT01284062|O2|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286346|NCT01284062|O1|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286347|NCT01284062|O3|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286465|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
286348|NCT01284062|O2|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286349|NCT01284062|O1|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286350|NCT01284062|O3|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286351|NCT01284062|O2|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286352|NCT01284062|O1|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286353|NCT01284062|O3|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286354|NCT01284062|O2|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286355|NCT01284062|O1|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286356|NCT01284062|O3|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286357|NCT01284062|O2|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286358|NCT01284062|O1|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286359|NCT01284062|O3|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286360|NCT01284062|O2|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286361|NCT01284062|O1|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286362|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286363|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286364|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286365|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286366|NCT01284062|E4|Reported Event|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286367|NCT01284062|E3|Reported Event|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286368|NCT01284062|E2|Reported Event|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286369|NCT01284062|E1|Reported Event|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
286370|NCT01283971|B3|Baseline|Total|Total of all reporting groups
286371|NCT01283971|B2|Baseline|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286372|NCT01283971|B1|Baseline|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286373|NCT01283971|P2|Participant Flow|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286374|NCT01283971|P1|Participant Flow|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286375|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286376|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286377|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286378|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286379|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286380|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286381|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286382|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286383|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286384|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
326788|NCT01181011|O2|Outcome|Amlodipine 5mg|
286385|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286386|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286387|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286388|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286389|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286390|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286391|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286392|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286393|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286394|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286395|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286396|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286397|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286398|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286399|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286400|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286401|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286402|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286403|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286404|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286405|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286406|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286407|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286408|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286409|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286410|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286411|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286412|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286413|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286414|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286415|NCT01283971|E2|Reported Event|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286416|NCT01283971|E1|Reported Event|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
286417|NCT01283581|B4|Baseline|Total|Total of all reporting groups
286418|NCT01283581|B3|Baseline|Vancomycin|Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
286419|NCT01283581|B2|Baseline|Linezolid|Linezolid 600 mg, BID
286420|NCT01283581|B1|Baseline|Delafloxacin IV|Delafloxacin 300 mg, BID
286421|NCT01283581|P3|Participant Flow|Vancomycin IV|Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
286422|NCT01283581|P2|Participant Flow|Linezolid IV|Linezolid 600 mg, BID
286423|NCT01283581|P1|Participant Flow|Delafloxacin IV|Delafloxacin 300 mg, BID
286424|NCT01283581|O3|Outcome|Vancomycin|Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
286425|NCT01283581|O2|Outcome|Linezolid|Linezolid 600 mg, BID
286426|NCT01283581|O1|Outcome|Delafloxacin IV|Delafloxacin 300 mg, BID
286427|NCT01283581|O3|Outcome|Vancomycin|Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
286428|NCT01283581|O2|Outcome|Linezolid|Linezolid 600 mg, BID
286429|NCT01283581|O1|Outcome|Delafloxacin IV|Delafloxacin 300 mg, BID
286430|NCT01283581|E3|Reported Event|Vancomycin|Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
286431|NCT01283581|E2|Reported Event|Linezolid|Linezolid 600 mg, BID
286432|NCT01283581|E1|Reported Event|Delafloxacin IV|Delafloxacin 300 mg, BID
286433|NCT01283555|B1|Baseline|Entire Study Population|Includes groups randomized to use the prefilled applicator first and the user-filled applicator first.
286434|NCT01283555|P2|Participant Flow|Prefilled Applicator First, Then User-filled|Plastic applicator (prefilled with Tenofovir 1% gel) used twice daily in first intervention period and user-filled applicator used twice daily in second intervention period (after washout period)
286435|NCT01283555|P1|Participant Flow|User-Filled Applicator First, Then Prefilled|User-filled paper applicator (filled using a tube of Tenofovir 1% gel)used twice daily in first intervention period and prefilled applicator used twice daily in second intervention period (after washout period)
286436|NCT01283555|O1|Outcome|Entire Study Population|Includes groups randomized to use the prefilled applicator first and the user-filled applicator first.
286437|NCT01283555|O1|Outcome|Entire Study Population|Includes groups randomized to use the prefilled applicator first and the user-filled applicator first.
286438|NCT01283555|O1|Outcome|Entire Study Population|Includes groups randomized to use the prefilled applicator first and the user-filled applicator first.
286439|NCT01283555|O2|Outcome|Colposcopic Findings After 7 Days of Product Use|Number of colposcopic findings identified during colposcopy after one week of twice daily product use (data from both study arms are combined). Note: Since a participant can have more than one colposcopic finding, the number of colposcopic findings does not necessarily equal the number of participants with colposcopic findings.
286440|NCT01283555|O1|Outcome|Baseline Colposcopic Findings|Number of colposcopic findings identified during baseline colposcopies for both study arms. Note: Since a participant can have more than one colposcopic finding, the number of colposcopic findings does not necessarily equal the number of participants with colposcopic findings.
286441|NCT01283555|O1|Outcome|Entire Study Population|Includes groups randomized to use the prefilled applicator first and the user-filled applicator first.
286442|NCT01283555|O1|Outcome|Entire Study Population|Includes groups randomized to use the prefilled applicator first and the user-filled applicator first.
286443|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
286444|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
286445|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
286446|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
286447|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
286448|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
286449|NCT01283555|O3|Outcome|Same|no preference between user-filled or prefilled applicator
286450|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
286451|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
286452|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
286453|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
286454|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
286455|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
286456|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
286457|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
286458|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
286459|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
286460|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
286461|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
286462|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
286463|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
286464|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
286468|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
286469|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
286470|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
286471|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
286472|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
286473|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
286474|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
286475|NCT01283555|E2|Reported Event|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
286476|NCT01283555|E1|Reported Event|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
286477|NCT01283516|B10|Baseline|Total|Total of all reporting groups
286478|NCT01283516|B9|Baseline|750 mg|Participants receiving 750 mg of LDK378
286479|NCT01283516|B8|Baseline|700 mg|Participants receiving 700 mg of LDK378
286480|NCT01283516|B7|Baseline|600 mg|Participants receiving 600 mg of LDK378
286481|NCT01283516|B6|Baseline|500 mg|Participants receiving 500 mg of LDK378
286482|NCT01283516|B5|Baseline|400 mg|Participants receiving 400 mg of LDK378
286483|NCT01283516|B4|Baseline|300 mg|Participants receiving 300 mg of LDK378
286484|NCT01283516|B3|Baseline|200 mg|Participants receiving 200 mg of LDK378
286485|NCT01283516|B2|Baseline|100 mg|Participants receiving 100 mg of LDK378
286486|NCT01283516|B1|Baseline|50 mg|Participants receiving 50 mg of LDK378
286487|NCT01283516|P9|Participant Flow|750 mg|Participants receiving 750 mg of LDK378
286488|NCT01283516|P8|Participant Flow|700 mg|Participants receiving 700 mg of LDK378
286489|NCT01283516|P7|Participant Flow|600 mg|Participants receiving 600 mg of LDK378
286490|NCT01283516|P6|Participant Flow|500 mg|Participants receiving 500 mg of LDK378
286491|NCT01283516|P5|Participant Flow|400 mg|Participants receiving 400 mg of LDK378
286492|NCT01283516|P4|Participant Flow|300 mg|Participants receiving 300 mg of LDK378
286493|NCT01283516|P3|Participant Flow|200 mg|Participants receiving 200 mg of LDK378
286494|NCT01283516|P2|Participant Flow|100 mg|Participants receiving 100 mg of LDK378
286495|NCT01283516|P1|Participant Flow|50 mg|Participants receiving 50 mg of LDK378
286496|NCT01283516|O1|Outcome|NSCLC With Prior Crizotinib|NSCLC patients who received prior crizotinib in the 750 mg dose group.
286497|NCT01283516|O1|Outcome|NSCLC With Prior Crizotinib|NSCLC patients who received prior crizotinib in the 750 mg dose group.
286498|NCT01283516|O9|Outcome|LDK378 750|Participants receiving 750 mg of LDK378.
286499|NCT01283516|O8|Outcome|LDK378 700 mg|Participants receiving 700 mg of LDK378
286500|NCT01283516|O7|Outcome|LDK378 600 mg|Participants receiving 600 mg of LDK378
286501|NCT01283516|O6|Outcome|LDK378 500 mg|Participants receiving 500 mg of LDK378
286502|NCT01283516|O5|Outcome|LDK378 400 mg|Participants receiving 400 mg of LDK378
286503|NCT01283516|O4|Outcome|LDK378 300 mg|Participants receiving 300 mg of LDK378
286504|NCT01283516|O3|Outcome|LDK378 200 mg|Participants receiving 200 mg of LDK378
286505|NCT01283516|O2|Outcome|LDK378 100 mg|Participants receiving 100 mg of LDK378
286506|NCT01283516|O1|Outcome|LDK378 50 mg|Participants receiving 50 mg of LDK378
286507|NCT01283516|E9|Reported Event|LDK378 750 mg|LDK378 750 mg
286508|NCT01283516|E8|Reported Event|LDK378 700 mg|LDK378 700 mg
286509|NCT01283516|E7|Reported Event|LDK378 600 mg|LDK378 600 mg
286510|NCT01283516|E6|Reported Event|LDK378 500 mg|LDK378 500 mg
286511|NCT01283516|E5|Reported Event|LDK378 400 mg|LDK378 400 mg
286512|NCT01283516|E4|Reported Event|LDK378 300 mg|LDK378 300 mg
286513|NCT01283516|E3|Reported Event|LDK378 200 mg|LDK378 200 mg
286514|NCT01283516|E2|Reported Event|LDK378 100 mg|LDK378 100 mg
286515|NCT01283516|E1|Reported Event|LDK378 50 mg|LDK378 50 mg
286516|NCT01283464|B3|Baseline|Total|Total of all reporting groups
286517|NCT01283464|B2|Baseline|Tretinoin|Tretinoin 0.02% cream
286518|NCT01283464|B1|Baseline|Retinol|Retinol 1.0% cream
286519|NCT01283464|P2|Participant Flow|Tretinoin|Tretinoin 0.02% cream to entire face daily or as tolerated for 6 months
286520|NCT01283464|P1|Participant Flow|Retinol|Retinol 1.0% cream to entire face daily or as tolerated for 6 months
286521|NCT01283464|O2|Outcome|Tretinoin|Tretinoin 0.02% cream
286522|NCT01283464|O1|Outcome|Retinol|Retinol 1.0% cream
286523|NCT01283464|E2|Reported Event|Tretinoin|Tretinoin 0.02% cream
286524|NCT01283464|E1|Reported Event|Retinol|Retinol 1.0% cream
286525|NCT01283334|B1|Baseline|Carboplatin, Cetuximab and Everolimus|"Carboplatin, cetuximab and RAD001 (everolimus)~Carboplatin, cetuximab and RAD001: For phase I, dose escalation will be 2.5mg, 5mg, 7.5mg or 10mg given orally on a daily basis"
286526|NCT01283334|P1|Participant Flow|Carboplatin, Cetuximab and Everolimus|"Carboplatin, cetuximab and RAD001 (everolimus)~Carboplatin, cetuximab and RAD001: For phase I, dose escalation will be 2.5mg, 5mg, 7.5mg or 10mg given orally on a daily basis"
286527|NCT01283334|O1|Outcome|Carboplatin, Cetuximab and Everolimus|"Carboplatin, cetuximab and RAD001 (everolimus)~Carboplatin, cetuximab and RAD001: For phase I, dose escalation will be 2.5mg, 5mg, 7.5mg or 10mg given orally on a daily basis"
286528|NCT01283334|O2|Outcome|Everolimus Dose Level -1 DLT|Carboplatin, cetuximab and RAD001 (everolimus) at Dose Level -1 (2.5 mg every other day)
286529|NCT01283334|O1|Outcome|Everolimus Dose Level 1 DLT|Carboplatin, cetuximab and RAD001 (everolimus) at Dose Level 1 (2.5 mg/day)
286530|NCT01283334|E1|Reported Event|Carboplatin, Cetuximab and Everolimus|"Carboplatin, cetuximab and RAD001 (everolimus)~Carboplatin, cetuximab and RAD001: For phase I, dose escalation will be 2.5mg, 5mg, 7.5mg or 10mg given orally on a daily basis"
286531|NCT01283321|B3|Baseline|Total|Total of all reporting groups
287304|NCT01280695|O5|Outcome|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
286532|NCT01283321|B2|Baseline|Group B: Apheresis Platelets|"single apheresis unit~apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding."
286533|NCT01283321|B1|Baseline|Group A: RiaSTAP|"Human fibrinogen concentrate~Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding"
286534|NCT01283321|P2|Participant Flow|Group B: Apheresis Platelets|apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding.
286535|NCT01283321|P1|Participant Flow|Group A: RiaSTAP|Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding
286536|NCT01283321|O2|Outcome|Group B: Apheresis Platelets|"single apheresis unit~apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding."
286537|NCT01283321|O1|Outcome|Group A: RiaSTAP|"Human fibrinogen concentrate~Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding"
286538|NCT01283321|E2|Reported Event|Group B: Apheresis Platelets|"single apheresis unit~apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding."
286539|NCT01283321|E1|Reported Event|Group A: RiaSTAP|"Human fibrinogen concentrate~Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding"
286540|NCT01283282|B1|Baseline|All Subjects|The subjects received clopidogrel 75 mg or placebo PO qd for the first 6 weeks then were switched to receive either placebo or clopidogrel 75 mg PO qd therapy for an additional 6 weeks without any wash out period in between.
286541|NCT01283282|P2|Participant Flow|Clopidogrel First/Then Placebo|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks then were switched to placebo PO qd therapy for an additional 6 weeks without any wash out period in between.
286542|NCT01283282|P1|Participant Flow|Placebo First/Then Clopidogrel|The subjects received placebo PO qd for the first 6 weeks then were switched to clopidogrel 75 mg PO qd therapy for an additional 6 weeks without any wash out period in between.
286543|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
286544|NCT01283282|O1|Outcome|Clopridogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
286545|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
286546|NCT01283282|O1|Outcome|Clopridogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
286547|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
286548|NCT01283282|O1|Outcome|Clopridogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
286549|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
286550|NCT01283282|O1|Outcome|Clopridogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
286551|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
286552|NCT01283282|O1|Outcome|Clopidogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
286553|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
286554|NCT01283282|O1|Outcome|Clopridogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
286555|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
286556|NCT01283282|O1|Outcome|Clopridogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
286557|NCT01283282|E2|Reported Event|Placebo|The subjects received clopidogrel 75 mg or placebo PO qd for the first 6 weeks then were switched to receive either placebo or clopidogrel 75 mg PO qd therapy for an additional 6 weeks without any wash out period in between.
286558|NCT01283282|E1|Reported Event|Clopidogrel|The subjects received clopidogrel 75 mg or placebo PO qd for the first 6 weeks then were switched to receive either placebo or clopidogrel 75 mg PO qd therapy for an additional 6 weeks without any wash out period in between.
286559|NCT01283152|B3|Baseline|Total|Total of all reporting groups
286560|NCT01283152|B2|Baseline|Lactulose|"Per standard of care~Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
286561|NCT01283152|B1|Baseline|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
286562|NCT01283152|P2|Participant Flow|Lactulose|"Per standard of care~Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
286563|NCT01283152|P1|Participant Flow|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
286564|NCT01283152|O2|Outcome|Lactulose|"Per standard of care~Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
286565|NCT01283152|O1|Outcome|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
286566|NCT01283152|O2|Outcome|Lactulose|"Per standard of care~Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
287305|NCT01280695|O4|Outcome|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
286567|NCT01283152|O1|Outcome|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
286568|NCT01283152|O2|Outcome|Lactulose|"Per standard of care~Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
286569|NCT01283152|O1|Outcome|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
286570|NCT01283152|E2|Reported Event|Lactulose|"Per standard of care~Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
286571|NCT01283152|E1|Reported Event|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
286572|NCT01283139|B5|Baseline|Total|Total of all reporting groups
286573|NCT01283139|B4|Baseline|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286574|NCT01283139|B3|Baseline|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286575|NCT01283139|B2|Baseline|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286576|NCT01283139|B1|Baseline|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286577|NCT01283139|P4|Participant Flow|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286578|NCT01283139|P3|Participant Flow|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286579|NCT01283139|P2|Participant Flow|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286580|NCT01283139|P1|Participant Flow|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286581|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286582|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286583|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286584|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286585|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286586|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286587|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286588|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286589|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286590|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286591|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286592|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286593|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286594|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286595|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286596|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286597|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286598|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286599|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286600|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286601|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286602|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286603|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286604|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286605|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286606|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286607|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286608|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286609|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286610|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286611|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286612|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286613|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286614|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286615|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286616|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
286617|NCT01283139|E4|Reported Event|Sifalimumab 1200 mg|Sifalimumab 1,200 mg administered intravenously for 48 weeks (Day 337).
286618|NCT01283139|E3|Reported Event|Sifalimumab 600 mg|Sifalimumab 600 mg administered intravenously for 48 weeks (Day 337).
286619|NCT01283139|E2|Reported Event|Sifalimumab 200 mg|Sifalimumab 200 milligram (mg) administered intravenously for 48 weeks (Day 337).
286620|NCT01283139|E1|Reported Event|Placebo|Placebo matching to sifalimumab administered intravenously for 48 weeks (Day 337).
286621|NCT01283035|B1|Baseline|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
286622|NCT01283035|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
286623|NCT01283035|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
286650|NCT01282814|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
286624|NCT01283035|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
286625|NCT01283035|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
286626|NCT01283035|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
286627|NCT01283035|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
286628|NCT01283035|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
286629|NCT01283035|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
286630|NCT01283022|B1|Baseline|MVI 200|MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
286631|NCT01283022|P1|Participant Flow|MVI 200|MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
286632|NCT01283022|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
286633|NCT01283022|O1|Outcome|MVI 200|MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
286634|NCT01283022|O1|Outcome|MVI 200|MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
286635|NCT01283022|E1|Reported Event|MVI 200|MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
286636|NCT01282866|B1|Baseline|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:~Treatment parameters: Fluence: 9-12J/cm^2, pulse duration: 30 to 70ms,medium to low vacuum levels.~All patients were treated in the Axilla area."
286637|NCT01282866|P1|Participant Flow|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:~Treatment parameters: Fluence: 9-12J/cm^2, pulse duration: 30 to 70ms,medium to low vacuum levels.~All patients were treated in the Axilla area."
286638|NCT01282866|O1|Outcome|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:~Treatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels.~All patients were treated in the Axilla area."
286639|NCT01282866|O1|Outcome|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:~Treatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels.~All patients were treated in the Axilla area."
286640|NCT01282866|O1|Outcome|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:~Treatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels.~All patients were treated in the Axilla area."
286641|NCT01282866|E1|Reported Event|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:~Treatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels.~All patients were treated in the Axilla area."
286642|NCT01282814|B3|Baseline|Total|Total of all reporting groups
286643|NCT01282814|B2|Baseline|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
286644|NCT01282814|B1|Baseline|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
286645|NCT01282814|P2|Participant Flow|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
286646|NCT01282814|P1|Participant Flow|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
286647|NCT01282814|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
286648|NCT01282814|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
286649|NCT01282814|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
286651|NCT01282814|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
286652|NCT01282814|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
286653|NCT01282814|E2|Reported Event|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
286654|NCT01282814|E1|Reported Event|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
286655|NCT01282801|B3|Baseline|Total|Total of all reporting groups
286656|NCT01282801|B2|Baseline|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
286657|NCT01282801|B1|Baseline|Velafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
286658|NCT01282801|P2|Participant Flow|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
286659|NCT01282801|P1|Participant Flow|Velafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
286660|NCT01282801|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
286661|NCT01282801|O1|Outcome|Velafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
286662|NCT01282801|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
286663|NCT01282801|O1|Outcome|Velafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
286664|NCT01282801|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
286665|NCT01282801|O1|Outcome|Velafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
286666|NCT01282801|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
286667|NCT01282801|O1|Outcome|Velafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
286668|NCT01282801|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
286669|NCT01282801|O1|Outcome|Velafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
286670|NCT01282801|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
286671|NCT01282801|O1|Outcome|Velafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
286672|NCT01282801|E2|Reported Event|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
286673|NCT01282801|E1|Reported Event|Velafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
286674|NCT01282723|B1|Baseline|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
286675|NCT01282723|P1|Participant Flow|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
286676|NCT01282723|O1|Outcome|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
286677|NCT01282723|E1|Reported Event|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
286678|NCT01282710|B1|Baseline|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
286679|NCT01282710|P1|Participant Flow|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
286680|NCT01282710|O1|Outcome|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
286681|NCT01282710|E1|Reported Event|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
286682|NCT01282476|B1|Baseline|Panobinostat/Rituximab|Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.
286683|NCT01282476|P1|Participant Flow|Panobinostat/Rituximab|Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.
286684|NCT01282476|O1|Outcome|Panobinostat/Rituximab|Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.
286685|NCT01282476|O1|Outcome|Panobinostat/Rituximab|Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.
286686|NCT01282476|O1|Outcome|Panobinostat/Rituximab|Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.
286687|NCT01282476|E1|Reported Event|Panobinostat/Rituximab|"single-arm, open-label; Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.~Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles."
286688|NCT01282424|B1|Baseline|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
286689|NCT01282424|P1|Participant Flow|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
286690|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
286691|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
286692|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
286693|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
286694|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
286695|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
286696|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
286697|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
286698|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
286699|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
286700|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
286701|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
286702|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
286703|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
286704|NCT01282424|E1|Reported Event|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
286705|NCT01282372|B1|Baseline|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
286706|NCT01282372|P1|Participant Flow|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
286707|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
286708|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
286709|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
286710|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
286711|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
286712|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
286713|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
286714|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
286715|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
286716|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
286717|NCT01282372|O3|Outcome|Participants With Moderate to Severe Rheumatic Disease - AS|Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
286718|NCT01282372|O2|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
286719|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - RA|Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
286720|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
286721|NCT01282372|O3|Outcome|Participants With Moderate to Severe Rheumatic Disease - AS|Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
286722|NCT01282372|O2|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
286723|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - RA|Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
286724|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
286725|NCT01282372|O3|Outcome|Participants With Moderate to Severe Rheumatic Disease - AS|Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
286726|NCT01282372|O2|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
286727|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - RA|Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
286728|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
286729|NCT01282372|O3|Outcome|Participants With Moderate to Severe Rheumatic Disease - AS|Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
286730|NCT01282372|O2|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
286731|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - RA|Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
286732|NCT01282372|E1|Reported Event|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
286733|NCT01282294|B1|Baseline|ETN PROtect|"There is only 1 cohort in this case series.~ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating"
286734|NCT01282294|P1|Participant Flow|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
286735|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
286736|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
286737|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
286738|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
286739|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
286740|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
286741|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
286742|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
286743|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
286744|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
286745|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
286746|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
286747|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
286748|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
286749|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
286750|NCT01282294|E1|Reported Event|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
286751|NCT01282242|B3|Baseline|Total|Total of all reporting groups
286752|NCT01282242|B2|Baseline|SIR <1.25|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.25 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
286753|NCT01282242|B1|Baseline|SIR <1.15|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.15 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
286754|NCT01282242|P2|Participant Flow|Secondary SIR <1.25|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.25 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
286755|NCT01282242|P1|Participant Flow|Primary SIR <1.15|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.15 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
286756|NCT01282242|O2|Outcome|SIR < 1.25|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.25 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
286757|NCT01282242|O1|Outcome|SIR <1.15|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.15 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
286758|NCT01282242|O2|Outcome|SIR < 1.25|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.25 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
286759|NCT01282242|O1|Outcome|SIR <1.15|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.15 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
286760|NCT01282242|E2|Reported Event|SIR <1.25|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.25 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
286761|NCT01282242|E1|Reported Event|SIR <1.15|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.15 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
286762|NCT01282229|B1|Baseline|All Participants|Subjects will receive the Laser Assisted New Attachment Procedure (LANAP protocol) using the pulsed FR Nd:YAG laser, Scaling and Root Planing alone, Modified Widman Flap surgery, and Coronal Debridement alone each in one randomized quadrant of their mouth at Baseline.
286763|NCT01282229|P1|Participant Flow|All Participants|Subjects will receive the Laser Assisted New Attachment Procedure (LANAP protocol) using the pulsed FR Nd:YAG laser, Scaling and Root Planing alone, Modified Widman Flap surgery, and Coronal Debridement alone each in one randomized quadrant of their mouth at Baseline.
286764|NCT01282229|O4|Outcome|Coronal Debridement|Quadrant treated with coronal debridement
286765|NCT01282229|O3|Outcome|Scaling and Root Planing|Quadrant treated with scaling and root planing alone
286766|NCT01282229|O2|Outcome|Modified Widman Flap|Quadrant treated with Modified Widman Flap surgery
286767|NCT01282229|O1|Outcome|LANAP Quadrant|"Treated with LANAP~LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
286768|NCT01282229|O4|Outcome|Coronal Debridement|Quadrant treated with coronal debridement
286769|NCT01282229|O3|Outcome|Scaling and Root Planing|Quadrant treated with scaling and root planing alone
286770|NCT01282229|O2|Outcome|Modified Widman Flap|Quadrant treated with Modified Widman Flap surgery
286771|NCT01282229|O1|Outcome|LANAP Quadrant|"Treated with LANAP~LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
286773|NCT01282229|O3|Outcome|Scaling and Root Planing|Quadrant treated with scaling and root planing alone
286774|NCT01282229|O2|Outcome|Modified Widman Flap|Quadrant treated with Modified Widman Flap surgery
286775|NCT01282229|O1|Outcome|LANAP Quadrant|"Treated with LANAP~LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
286776|NCT01282229|O4|Outcome|Coronal Debridement|Quadrant treated with coronal debridement
286777|NCT01282229|O3|Outcome|Scaling and Root Planing|Quadrant treated with scaling and root planing alone
286778|NCT01282229|O2|Outcome|Modified Widman Flap|Quadrant treated with Modified Widman Flap surgery
286779|NCT01282229|O1|Outcome|LANAP Quadrant|"Treated with LANAP~LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
286780|NCT01282229|O8|Outcome|Coronal Debridement (≥7mm Pockets)|Quadrant treated with coronal debridement
286781|NCT01282229|O7|Outcome|Coronal Debridement (5-6mm Pockets)|Quadrant treated with coronal debridement
286782|NCT01282229|O6|Outcome|Scaling and Root Planing (≥7mm Pockets)|Quadrant treated with scaling and root planing alone
286783|NCT01282229|O5|Outcome|Scaling and Root Planing (5-6mm Pockets)|Quadrant treated with scaling and root planing alone
286784|NCT01282229|O4|Outcome|Modified Widman Flap (≥7mm Pockets)|Quadrant treated with Modified Widman Flap surgery
286785|NCT01282229|O3|Outcome|Modified Widman Flap (5-6mm Pockets)|Quadrant treated with Modified Widman Flap surgery
286786|NCT01282229|O2|Outcome|LANAP Quadrant (≥7mm Pockets)|"Treated with LANAP~LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
286787|NCT01282229|O1|Outcome|LANAP Quadrant (5-6mm Pockets)|"Treated with LANAP~LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
286788|NCT01282229|E4|Reported Event|Coronal Debridement|Quadrant treated with coronal debridement
286789|NCT01282229|E3|Reported Event|Scaling and Root Planing|Quadrant treated with scaling and root planing alone
286790|NCT01282229|E2|Reported Event|Modified Widman Flap|Quadrant treated with Modified Widman Flap surgery
286791|NCT01282229|E1|Reported Event|LANAP Quadrant|"Treated with LANAP~LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
286792|NCT01282203|B1|Baseline|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286793|NCT01282203|P1|Participant Flow|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286794|NCT01282203|O3|Outcome|Anesthesia With Sevorane|Duration of experience with Sevorane.
286795|NCT01282203|O2|Outcome|Inhalation Anesthesia|Duration of experience with inhalation anesthesia.
286796|NCT01282203|O1|Outcome|General Anesthesia|Duration of experience with general anesthesia.
286797|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286798|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286799|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286800|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286801|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286802|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286803|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286804|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286805|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286806|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286807|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286808|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286809|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286810|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286811|NCT01282203|E1|Reported Event|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286812|NCT01282164|B3|Baseline|Total|Total of all reporting groups
286813|NCT01282164|B2|Baseline|Control|"The control group will consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.~glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with T2DM, CAD, CVD, seizure"
286814|NCT01282164|B1|Baseline|Study Patients|"patients with growth hormone deficiency or hypothalamic-pituitary disorders~Glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with T2DM, CAD, CVD, seizure"
286815|NCT01282164|P2|Participant Flow|Control|"The control group will consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.~glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with T2DM, CAD, CVD, seizure"
286816|NCT01282164|P1|Participant Flow|Study Patients|"patients with growth hormone deficiency or hypothalamic-pituitary disorders~Glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg adrenocorticotropin hormone (ACTH) stimulation test in subjects with type 2 diabetes mellitus (T2DM), coronary artery disease (CAD), cerebrovascular disease (CVD), seizure"
286817|NCT01282164|O1|Outcome|Patients Older Than 65|Three patients with adult onset hypothalamic-pituitary disease underwent who were older than 65 years of age underwent ACTH stimulation test instead of ITT.
286818|NCT01282164|O3|Outcome|Patients With 3 or More PHD- Weight Based GST|Patients with hypothalamic-pituitary disorders and three or more pituitary hormone deficiency (PHD) other than GH deficiency
286819|NCT01282164|O2|Outcome|Patients With 3 or More PHD- Fixed Dose GST|Patients with hypothalamic-pituitary disorders and three or more pituitary hormone deficiency (PHD) other than GH deficiency
286820|NCT01282164|O1|Outcome|Patients With 3 or More PHD- Insulin Tolerance Test|"Patients with hypothalamic-pituitary disorders and three or more pituitary hormone deficiency (PHD) other than GH deficiency~insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test was used in 3 subjects who were not eligible for ITT"
286821|NCT01282164|O3|Outcome|Control Group- Weight-based GST|The control group consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.
286822|NCT01282164|O2|Outcome|Control Group- Fixed-dose GST|The control group consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.
286823|NCT01282164|O1|Outcome|Control Group- ITT|The control group consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site did not enroll the control group. All underwent insulin tolerance test using 0.10-0.15 U/kg
286824|NCT01282164|O3|Outcome|Patients With 1-2 PHD- Weight Based GST|Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency (PHD) other than GH deficiency
286825|NCT01282164|O2|Outcome|Patients With 1-2 PHD- Fixed Dose GST|Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency (PHD) other than GH deficiency
286826|NCT01282164|O1|Outcome|Patients With 1-2 PHD- Insulin Tolerance Test|"Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency (PHD) other than GH deficiency~insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test was used in 3 subjects who were not eligible for ITT"
286827|NCT01282164|O3|Outcome|Patients With 3 or More PHD- Weight Based GST|Patients with hypothalamic-pituitary disorders and three or more pituitary hormone deficiency (PHD) other than GH deficiency
286828|NCT01282164|O2|Outcome|Patients With 3 or More PHD- Fixed Dose GST|Patients with hypothalamic-pituitary disorders and three or more pituitary hormone deficiency (PHD) other than GH deficiency
286829|NCT01282164|O1|Outcome|Patients With 3 or More PHD- Insulin Tolerance Test|"Patients with hypothalamic-pituitary disorders and three or more pituitary hormone deficiency (PHD) other than GH deficiency~insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test was used in 3 subjects who were not eligible for ITT"
286830|NCT01282164|O3|Outcome|Control Group- Weight-based GST|The control group consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.
286831|NCT01282164|O2|Outcome|Control Group- Fixed-dose GST|The control group consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.
286832|NCT01282164|O1|Outcome|Control Group- ITT|The control group consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site did not enroll the control group. All underwent insulin tolerance test using 0.10-0.15 U/kg
286833|NCT01282164|O3|Outcome|Patients With 1-2 PHD- Weight Based GST|Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency (PHD) other than GH deficiency
286834|NCT01282164|O2|Outcome|Patients With 1-2 PHD- Fixed Dose GST|Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency (PHD) other than GH deficiency
286835|NCT01282164|O1|Outcome|Patients With 1-2 PHD- Insulin Tolerance Test|"Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency (PHD) other than GH deficiency~insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test was used in 3 subjects who were not eligible for ITT"
286836|NCT01282164|E2|Reported Event|Control|"The control group will consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.~glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with T2DM, CAD, CVD, seizure"
286837|NCT01282164|E1|Reported Event|Study Patients|"patients with hypothalamic-pituitary disorders~Glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with T2DM, CAD, CVD, seizure"
286838|NCT01282138|B3|Baseline|Total|Total of all reporting groups
286839|NCT01282138|B2|Baseline|Tears Naturale II|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
286840|NCT01282138|B1|Baseline|Patanol|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
286841|NCT01282138|P2|Participant Flow|Tears Naturale II|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
286842|NCT01282138|P1|Participant Flow|Patanol|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
286843|NCT01282138|O2|Outcome|Tears Naturale II|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
286844|NCT01282138|O1|Outcome|Patanol|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
286845|NCT01282138|O2|Outcome|Tears Naturale II|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
287005|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
286846|NCT01282138|O1|Outcome|Patanol|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
286847|NCT01282138|E2|Reported Event|Tears Naturale II|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
286848|NCT01282138|E1|Reported Event|Patanol|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
286849|NCT01282086|B1|Baseline|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286850|NCT01282086|P1|Participant Flow|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286851|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286852|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286853|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286854|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286855|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286856|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286857|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286858|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286859|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery.
286860|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286861|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286862|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286863|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286864|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286865|NCT01282086|E1|Reported Event|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
286866|NCT01281917|B1|Baseline|Velcade Plus Temsirolimus|"Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)~Treat for up to 6 cycles, cycles are 35 days long.~Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)~Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)"
286867|NCT01281917|P1|Participant Flow|Velcade Plus Temsirolimus|"Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)~Treat for up to 6 cycles, cycles are 35 days long.~Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)~Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)"
286868|NCT01281917|O1|Outcome|Velcade Plus Temsirolimus|"Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)~Treat for up to 6 cycles, cycles are 35 days long.~Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)~Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)"
286869|NCT01281917|O1|Outcome|Velcade Plus Temsirolimus|"Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)~Treat for up to 6 cycles, cycles are 35 days long.~Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)~Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)"
286870|NCT01281917|O1|Outcome|Velcade Plus Temsirolimus|"Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)~Treat for up to 6 cycles, cycles are 35 days long.~Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)~Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)"
286871|NCT01281917|O1|Outcome|Velcade Plus Temsirolimus|"Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)~Treat for up to 6 cycles, cycles are 35 days long.~Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)~Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)"
286872|NCT01281917|O1|Outcome|Velcade Plus Temsirolimus|"Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)~Treat for up to 6 cycles, cycles are 35 days long.~Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)~Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)"
286873|NCT01281917|O1|Outcome|Velcade Plus Temsirolimus|"Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)~Treat for up to 6 cycles, cycles are 35 days long.~Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)~Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)"
286874|NCT01281917|O1|Outcome|Velcade Plus Temsirolimus|"Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)~Treat for up to 6 cycles, cycles are 35 days long.~Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)~Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)"
286875|NCT01281917|E1|Reported Event|Velcade Plus Temsirolimus|"Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)~Treat for up to 6 cycles, cycles are 35 days long.~Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)~Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)"
286876|NCT01281865|B3|Baseline|Total|Total of all reporting groups
286877|NCT01281865|B2|Baseline|Arm 2-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
286878|NCT01281865|B1|Baseline|Arm 1-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
286879|NCT01281865|P2|Participant Flow|Arm 2-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
286880|NCT01281865|P1|Participant Flow|Arm 1-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
326789|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
286881|NCT01281865|O2|Outcome|Arm 2-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
286882|NCT01281865|O1|Outcome|Arm 1-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
286883|NCT01281865|E2|Reported Event|Arm 2-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
286884|NCT01281865|E1|Reported Event|Arm 1-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
286885|NCT01281839|B3|Baseline|Total|Total of all reporting groups
286886|NCT01281839|B2|Baseline|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286887|NCT01281839|B1|Baseline|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286888|NCT01281839|P2|Participant Flow|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286889|NCT01281839|P1|Participant Flow|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286890|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286891|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286892|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286893|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286894|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286895|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286896|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286897|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286898|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286899|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286900|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286901|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286902|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286903|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286904|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286905|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286906|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286907|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286908|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286909|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286910|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286911|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286912|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286913|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286914|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286915|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286916|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286917|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286918|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286919|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286920|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286921|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286922|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286923|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
287006|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
326790|NCT01181011|O2|Outcome|Telmisartan 80mg|
286924|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286925|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286926|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286927|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286928|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286929|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286930|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286931|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286932|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286933|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286934|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286935|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286936|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286937|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286938|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286939|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286940|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286941|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286942|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286943|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
287007|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
326791|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
286944|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286945|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286946|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286947|NCT01281839|E2|Reported Event|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
286948|NCT01281839|E1|Reported Event|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
286949|NCT01281644|B1|Baseline|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual arm within each subject to receive either laser therapy on the right arm or on the left arm.~Each subject received treatment using the 810 nm pulsed diode laser to the arm randomized to be the treatment site."
286950|NCT01281644|P1|Participant Flow|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual arm within each subject to receive either laser therapy on the right arm or on the left arm.~Each subject received treatment using the 810 nm pulsed diode laser to the arm randomized to be the treatment site."
286951|NCT01281644|O2|Outcome|45-60 J Diode Laser Therapy|"Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms.~Diode Laser: 810 nm diode laser"
286952|NCT01281644|O1|Outcome|No Laser Treatment|
286953|NCT01281644|O2|Outcome|45-60 J Diode Laser Therapy|"Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms.~Diode Laser: 810 nm diode laser"
286954|NCT01281644|O1|Outcome|No Laser Treatment|
286955|NCT01281644|E2|Reported Event|45-60 J Diode Laser Therapy|"Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms.~Diode Laser: 810 nm diode laser"
286956|NCT01281644|E1|Reported Event|No Laser Treatment|
286957|NCT01281501|B3|Baseline|Total|Total of all reporting groups
286958|NCT01281501|B2|Baseline|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
286959|NCT01281501|B1|Baseline|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
286960|NCT01281501|P2|Participant Flow|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
286961|NCT01281501|P1|Participant Flow|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
286962|NCT01281501|O2|Outcome|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
286963|NCT01281501|O1|Outcome|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
286964|NCT01281501|O2|Outcome|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
286965|NCT01281501|O1|Outcome|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
286966|NCT01281501|O2|Outcome|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
286967|NCT01281501|O1|Outcome|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
286968|NCT01281501|O2|Outcome|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
286969|NCT01281501|O1|Outcome|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
286970|NCT01281501|E2|Reported Event|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
286971|NCT01281501|E1|Reported Event|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
286972|NCT01281475|B3|Baseline|Total|Total of all reporting groups
286973|NCT01281475|B2|Baseline|Placebo|"The placebo (in this study, microcellulose) is not expected to have any effect.~It is also taken 3 times a day, just like Levodopa."
286974|NCT01281475|B1|Baseline|Levodopa|"Levodopa is a prodrug that delivers dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa.~Levodopa/carbidopa: Levodopa/Carbidopa (4:1)~Dosages are based on levodopa.~Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
286975|NCT01281475|P2|Participant Flow|Placebo|The placebo (in this study, microcellulose) is not expected to have any effect.
286976|NCT01281475|P1|Participant Flow|Levodopa|"Levodopa is a prodrug that delivers dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa.~Levodopa/carbidopa: Levodopa/Carbidopa (4:1)~Dosages are based on levodopa.~Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
287008|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
286977|NCT01281475|O2|Outcome|Placebo|"The placebo contains excipients similar to those in the active drug, but it does not contain levodopa or carbidopa, so it is not expected to have any effect.~Placebo Oral Capsule: The placebo contains excipients similar to those in the active drug, but it does not contain levodopa or carbidopa."
286978|NCT01281475|O1|Outcome|Levodopa|"Levodopa is prescribed as a combination of levodopa/carbidopa (4:1) to reduce the peripheral side effects. The dosage used was 15 mg/kg/day in 3 divided doses.~Levodopa: Levodopa/Carbidopa (4:1)~Dosages are based on levodopa.~Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
286979|NCT01281475|O2|Outcome|Placebo|"The placebo (in this study, microcellulose) is not expected to have any effect.~The placebo capsules are taken 3 times a day, just like the levodopa / carbidopa capsules"
286980|NCT01281475|O1|Outcome|Levodopa|"Levodopa is a prodrug that delivers dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa.~Levodopa/carbidopa: Levodopa/Carbidopa (4:1)~Dosages are based on levodopa.~Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
286981|NCT01281475|E2|Reported Event|Placebo|The placebo (in this study, microcellulose) is not expected to have any effect.
286982|NCT01281475|E1|Reported Event|Levodopa|"Levodopa is a prodrug that delivers dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa.~Levodopa/carbidopa: Levodopa/Carbidopa (4:1)~Dosages are based on levodopa.~Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
286983|NCT01281306|B8|Baseline|Total|Total of all reporting groups
286984|NCT01281306|B7|Baseline|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
286985|NCT01281306|B6|Baseline|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
286986|NCT01281306|B5|Baseline|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
286987|NCT01281306|B4|Baseline|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
286988|NCT01281306|B3|Baseline|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
286989|NCT01281306|B2|Baseline|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
286990|NCT01281306|B1|Baseline|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
286991|NCT01281306|P7|Participant Flow|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
286992|NCT01281306|P6|Participant Flow|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
286993|NCT01281306|P5|Participant Flow|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
286994|NCT01281306|P4|Participant Flow|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
286995|NCT01281306|P3|Participant Flow|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
286996|NCT01281306|P2|Participant Flow|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
286997|NCT01281306|P1|Participant Flow|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
286998|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
286999|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
287000|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
287001|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
287002|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
287003|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
287004|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
287283|NCT01280695|P1|Participant Flow|Placebo|Placebo capsule once daily
287009|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
287010|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
287011|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
287012|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
287013|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
287014|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
287015|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
287016|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
287017|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
287018|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
287019|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
287020|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
287021|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
287022|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
287023|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
287024|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
287025|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
287026|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
287027|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
287028|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
287029|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
287030|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
287031|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
287032|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
287033|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
287034|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
287035|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
287036|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
287037|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
287038|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
287039|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
287040|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
287041|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
287042|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
287043|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
287044|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
287045|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
287046|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
287047|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
287048|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
287049|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
287050|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
287051|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
287052|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
287053|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
287054|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
287055|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
287056|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
287057|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
287058|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
287059|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
287060|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
287061|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
287062|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
287063|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
287064|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
287065|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
287066|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
287067|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
287068|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
287069|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
287070|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
287071|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
287072|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
287073|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
287074|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
287075|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
287076|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
287077|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
287078|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
287079|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
287080|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
287081|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
287082|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
287083|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
287084|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
287085|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
287086|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
287087|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
287088|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
287089|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
287090|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
287091|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
287092|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
287093|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
287094|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
287095|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
287096|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
287097|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
287098|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
287099|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
287100|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
287101|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
287102|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
287103|NCT01281306|E7|Reported Event|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
287104|NCT01281306|E6|Reported Event|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
287105|NCT01281306|E5|Reported Event|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
287106|NCT01281306|E4|Reported Event|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
287107|NCT01281306|E3|Reported Event|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
287108|NCT01281306|E2|Reported Event|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
287109|NCT01281306|E1|Reported Event|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
287110|NCT01281202|B3|Baseline|Total|Total of all reporting groups
287111|NCT01281202|B2|Baseline|Placebo|Participants received Vigabatrin placebo table orally once daily for 7 weeks.
287112|NCT01281202|B1|Baseline|CPP-109 Vigabatrin Tablets|Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.
287113|NCT01281202|P2|Participant Flow|Placebo|Participants received Vigabatrin placebo table orally once daily for 7 weeks.
287114|NCT01281202|P1|Participant Flow|CPP-109 Vigabatrin Tablets|Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.
287115|NCT01281202|O2|Outcome|Placebo|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase~During treatment, subject received Vigabatrin matching placebo tablets, bid, for 9 weeks~Subject were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)"
287116|NCT01281202|O1|Outcome|CPP-109 Vigabatrin Tablets|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase~During treatment, subject received 3 CPP-109 Vigabatrin 500 mg Tablets, bid, for 9 weeks~Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)"
287117|NCT01281202|O2|Outcome|Matching Placebo|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase. During Treatment, subjects received Vigabatrin matching placebo tablets, bid, for 9 weeks.~Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)"
287118|NCT01281202|O1|Outcome|CPP-109 Vigabatrin Tablets|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase. During treatment, subjects received 3 CPP-109 Vigabatrin 500 mg Tablets, bid, for 9 weeks.~Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)"
287119|NCT01281202|E2|Reported Event|Placebo|Participants received Vigabatrin placebo table orally once daily for 7 weeks.
287120|NCT01281202|E1|Reported Event|CPP-109 Vigabatrin Tablets|Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.
287121|NCT01281124|B1|Baseline|Treatment (Azacitidine)|Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
287122|NCT01281124|P1|Participant Flow|Treatment (5-Azacytidine)|Patients receive 5-azacitidine subcutaneously at the starting dose level of 75 mg/m2 on an outpatient basis daily for 7 days on a 28 day cycle.
287123|NCT01281124|O1|Outcome|Treatment (Azacitidine)|Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
287124|NCT01281124|O1|Outcome|Treatment (5-Azacytidine)|Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
287125|NCT01281124|O1|Outcome|Treatment (5-Azacyitidine)|Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
287126|NCT01281124|E1|Reported Event|Treatment (Azacitidine)|Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
287127|NCT01281007|B3|Baseline|Total|Total of all reporting groups
287128|NCT01281007|B2|Baseline|Aciclovir 200 mg|"1 tablet every 4 hours (excluding nocturnal dose) for 5 days~Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days"
287129|NCT01281007|B1|Baseline|Famciclovir 125 mg|"1 tablet every 12 hours for 5 days~Famciclovir: Famciclovir 125 mg every 12 hours for 5 days"
287130|NCT01281007|P2|Participant Flow|Aciclovir 200 mg|"1 tablet every 4 hours (excluding nocturnal dose) for 5 days~Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days"
287131|NCT01281007|P1|Participant Flow|Famciclovir 125 mg|"1 tablet every 12 hours for 5 days~Famciclovir: Famciclovir 125 mg every 12 hours for 5 days"
287132|NCT01281007|O2|Outcome|Aciclovir 200 mg|"1 tablet every 4 hours (excluding nocturnal dose) for 5 days~Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days"
287133|NCT01281007|O1|Outcome|Famciclovir 125 mg|"1 tablet every 12 hours for 5 days~Famciclovir: Famciclovir 125 mg every 12 hours for 5 days"
287134|NCT01281007|E2|Reported Event|Aciclovir 200 mg|"1 tablet every 4 hours (excluding nocturnal dose) for 5 days~Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days"
287135|NCT01281007|E1|Reported Event|Famciclovir 125 mg|"1 tablet every 12 hours for 5 days~Famciclovir: Famciclovir 125 mg every 12 hours for 5 days"
287136|NCT01280981|B1|Baseline|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
287137|NCT01280981|P1|Participant Flow|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
287138|NCT01280981|O1|Outcome|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
287139|NCT01280981|O1|Outcome|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
287140|NCT01280981|O1|Outcome|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
287141|NCT01280981|O1|Outcome|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
287142|NCT01280981|O1|Outcome|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
287143|NCT01280981|O1|Outcome|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
287144|NCT01280981|E1|Reported Event|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
287145|NCT01280968|B3|Baseline|Total|Total of all reporting groups
287146|NCT01280968|B2|Baseline|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
287147|NCT01280968|B1|Baseline|NIC002 Vaccine in Aluminum Hydroxide|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
287148|NCT01280968|P2|Participant Flow|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
287149|NCT01280968|P1|Participant Flow|NIC002 Vaccine in Aluminum Hydroxide|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
287150|NCT01280968|O3|Outcome|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
287151|NCT01280968|O2|Outcome|NIC002, Tertile With Highest Antibody Binding Capacity|
287152|NCT01280968|O1|Outcome|NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
287153|NCT01280968|O3|Outcome|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
287154|NCT01280968|O2|Outcome|NIC002, Tertile With Highest Antibody Binding Capacity|
287155|NCT01280968|O1|Outcome|NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
287156|NCT01280968|O3|Outcome|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
287157|NCT01280968|O2|Outcome|NIC002, Tertile With Highest Antibody Binding Capacity|
287158|NCT01280968|O1|Outcome|NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
287159|NCT01280968|O3|Outcome|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
287160|NCT01280968|O2|Outcome|NIC002, Tertile With Highest Antibody Binding Capacity|
287161|NCT01280968|O1|Outcome|NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
287162|NCT01280968|E2|Reported Event|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
287163|NCT01280968|E1|Reported Event|NIC002 Vaccine in Aluminum Hydroxide|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
287164|NCT01280955|B1|Baseline|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287165|NCT01280955|P1|Participant Flow|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287166|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287167|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287168|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287169|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287170|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287171|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287172|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287173|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287174|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287284|NCT01280695|O5|Outcome|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
287175|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287176|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287177|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287178|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287179|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287180|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287181|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287182|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287183|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287184|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287185|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287186|NCT01280955|O1|Outcome|Transplant Recipients|"Transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.~Plerixafor: Matched sibling or Dual Cord donor subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs."
287187|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287188|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287189|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287190|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287191|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287192|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287193|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
287194|NCT01280955|E1|Reported Event|Transplant Recipients|"This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.~Adverse Events were monitored for 29 transplant recipients"
287195|NCT01280942|B3|Baseline|Total|Total of all reporting groups
287196|NCT01280942|B2|Baseline|Nurse Notification of EWS Alert|"Patients admitted to 4 GHWs designated as intervention wards at BJH. Nurses will be notified when patients on these wards satisfy the EWS algorithm. Some patients will be asked to wear the wireless remote sensors.~EWS Nursing Alerts: An automated algorithm (EWS) will identify patients at potential risk of clinical deterioration. When a patient satisfies the algorithm, a nurse on the patient's ward will be notified. S/he will assess the patient and institute any interventions that are clinically required.~Wireless Remote Sensor: A subset of patients will be consented to wear a wireless sensor device which will monitor heart rate and level of oxygen in the blood."
287197|NCT01280942|B1|Baseline|Control|Patients admitted to 4 GHWs designated as controls. Nurses will not be notified when patients on these GHWs satisfy the EWS algorithm. They will also not wear the wireless sensor devices.
287285|NCT01280695|O4|Outcome|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
287286|NCT01280695|O3|Outcome|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
287198|NCT01280942|P2|Participant Flow|Nurse Notification of EWS Alert|"Patients admitted to 4 GHWs designated as intervention wards at BJH. Nurses will be notified when patients on these wards satisfy the EWS algorithm. Some patients will be asked to wear the wireless remote sensors.~EWS Nursing Alerts: An automated algorithm (EWS) will identify patients at potential risk of clinical deterioration. When a patient satisfies the algorithm, a nurse on the patient's ward will be notified. S/he will assess the patient and institute any interventions that are clinically required.~Wireless Remote Sensor: A subset of patients will be consented to wear a wireless sensor device which will monitor heart rate and level of oxygen in the blood."
287199|NCT01280942|P1|Participant Flow|Control|Patients admitted to 4 GHWs designated as controls. Nurses will not be notified when patients on these GHWs satisfy the EWS algorithm. They will also not wear the wireless sensor devices.
287200|NCT01280942|O2|Outcome|Nurse Notification of EWS Alert|"Patients admitted to 4 GHWs designated as intervention wards at BJH. Nurses will be notified when patients on these wards satisfy the EWS algorithm. Some patients will be asked to wear the wireless remote sensors.~EWS Nursing Alerts: An automated algorithm (EWS) will identify patients at potential risk of clinical deterioration. When a patient satisfies the algorithm, a nurse on the patient's ward will be notified. S/he will assess the patient and institute any interventions that are clinically required.~Wireless Remote Sensor: A subset of patients will be consented to wear a wireless sensor device which will monitor heart rate and level of oxygen in the blood."
287201|NCT01280942|O1|Outcome|Control|Patients admitted to 4 GHWs designated as controls. Nurses will not be notified when patients on these GHWs satisfy the EWS algorithm. They will also not wear the wireless sensor devices.
287202|NCT01280942|O2|Outcome|Nurse Notification of EWS Alert|"Patients admitted to 4 GHWs designated as intervention wards at BJH. Nurses will be notified when patients on these wards satisfy the EWS algorithm. Some patients will be asked to wear the wireless remote sensors.~EWS Nursing Alerts: An automated algorithm (EWS) will identify patients at potential risk of clinical deterioration. When a patient satisfies the algorithm, a nurse on the patient's ward will be notified. S/he will assess the patient and institute any interventions that are clinically required.~Wireless Remote Sensor: A subset of patients will be consented to wear a wireless sensor device which will monitor heart rate and level of oxygen in the blood."
287203|NCT01280942|O1|Outcome|Control|Patients admitted to 4 GHWs designated as controls. Nurses will not be notified when patients on these GHWs satisfy the EWS algorithm. They will also not wear the wireless sensor devices.
287204|NCT01280942|E2|Reported Event|Nurse Notification of EWS Alert|"Patients admitted to 4 GHWs designated as intervention wards at BJH. Nurses will be notified when patients on these wards satisfy the EWS algorithm. Some patients will be asked to wear the wireless remote sensors.~EWS Nursing Alerts: An automated algorithm (EWS) will identify patients at potential risk of clinical deterioration. When a patient satisfies the algorithm, a nurse on the patient's ward will be notified. S/he will assess the patient and institute any interventions that are clinically required.~Wireless Remote Sensor: A subset of patients will be consented to wear a wireless sensor device which will monitor heart rate and level of oxygen in the blood."
287205|NCT01280942|E1|Reported Event|Control|Patients admitted to 4 GHWs designated as controls. Nurses will not be notified when patients on these GHWs satisfy the EWS algorithm. They will also not wear the wireless sensor devices.
287206|NCT01280903|B3|Baseline|Total|Total of all reporting groups
287207|NCT01280903|B2|Baseline|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287208|NCT01280903|B1|Baseline|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287209|NCT01280903|P2|Participant Flow|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287210|NCT01280903|P1|Participant Flow|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287287|NCT01280695|O2|Outcome|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
287288|NCT01280695|O1|Outcome|Placebo|Placebo capsule once daily
287289|NCT01280695|O5|Outcome|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
287290|NCT01280695|O4|Outcome|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
287211|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287212|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287213|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287214|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287215|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287216|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287217|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287218|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287219|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287291|NCT01280695|O3|Outcome|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
287292|NCT01280695|O2|Outcome|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
287220|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287221|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287222|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287223|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287224|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287225|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287226|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287227|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287228|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287293|NCT01280695|O1|Outcome|Placebo|Placebo capsule once daily
287294|NCT01280695|O5|Outcome|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
326792|NCT01181011|O2|Outcome|Telmisartan 80mg|
287229|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287230|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287231|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287232|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287233|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287234|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287235|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287236|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287237|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287295|NCT01280695|O4|Outcome|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
287296|NCT01280695|O3|Outcome|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
287238|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287239|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287240|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287241|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287242|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287243|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287244|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287245|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287246|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287297|NCT01280695|O2|Outcome|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
287298|NCT01280695|O1|Outcome|Placebo|Placebo capsule once daily
326793|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
287247|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287248|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287249|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287250|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287251|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287252|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287253|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287254|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287255|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287299|NCT01280695|O5|Outcome|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
287300|NCT01280695|O4|Outcome|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
287256|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287257|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287258|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287259|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287260|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287261|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287262|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287263|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287264|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287301|NCT01280695|O3|Outcome|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
287302|NCT01280695|O2|Outcome|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
287303|NCT01280695|O1|Outcome|Placebo|Placebo capsule once daily
287265|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287266|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287267|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287268|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287269|NCT01280903|O2|Outcome|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287270|NCT01280903|O1|Outcome|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287271|NCT01280903|E2|Reported Event|Attention-Control|"Senior Health Information Intervention~Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287272|NCT01280903|E1|Reported Event|STAR Intervention|"Staying Active with Arthritis Intervention~STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up."
287273|NCT01280695|B6|Baseline|Total|Total of all reporting groups
287274|NCT01280695|B5|Baseline|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
287275|NCT01280695|B4|Baseline|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
287276|NCT01280695|B3|Baseline|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
287277|NCT01280695|B2|Baseline|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
287278|NCT01280695|B1|Baseline|Placebo|Placebo capsule once daily
287279|NCT01280695|P5|Participant Flow|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
287280|NCT01280695|P4|Participant Flow|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
287281|NCT01280695|P3|Participant Flow|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
287282|NCT01280695|P2|Participant Flow|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
287306|NCT01280695|O3|Outcome|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
287307|NCT01280695|O2|Outcome|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
287308|NCT01280695|O1|Outcome|Placebo|Placebo capsule once daily
287309|NCT01280695|O5|Outcome|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
287310|NCT01280695|O4|Outcome|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
287311|NCT01280695|O3|Outcome|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
287312|NCT01280695|O2|Outcome|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
287313|NCT01280695|O1|Outcome|Placebo|Placebo capsule once daily
287314|NCT01280695|E5|Reported Event|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
287315|NCT01280695|E4|Reported Event|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
287316|NCT01280695|E3|Reported Event|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
287317|NCT01280695|E2|Reported Event|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
287318|NCT01280695|E1|Reported Event|Placebo|Placebo capsule once daily
287319|NCT01280656|B4|Baseline|Total|Total of all reporting groups
287320|NCT01280656|B3|Baseline|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287321|NCT01280656|B2|Baseline|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287322|NCT01280656|B1|Baseline|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287323|NCT01280656|P3|Participant Flow|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287324|NCT01280656|P2|Participant Flow|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287325|NCT01280656|P1|Participant Flow|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for Chronic Hepatitis C (CHC) according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287326|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287327|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287328|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287329|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287330|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287331|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287332|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287333|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287334|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287335|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287336|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287337|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287395|NCT01280591|P1|Participant Flow|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
287338|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287339|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287340|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287341|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287342|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287343|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287344|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287345|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287346|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287347|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287348|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287349|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287350|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287351|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287352|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287353|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287354|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287355|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287356|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287357|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287358|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287359|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287360|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
326794|NCT01181011|O2|Outcome|Telmisartan 80mg|
287361|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287362|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287363|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287364|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
287365|NCT01280656|E3|Reported Event|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy.
287366|NCT01280656|E2|Reported Event|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy
287367|NCT01280656|E1|Reported Event|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy.
287368|NCT01280604|B3|Baseline|Total|Total of all reporting groups
287369|NCT01280604|B2|Baseline|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
287370|NCT01280604|B1|Baseline|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
287371|NCT01280604|P2|Participant Flow|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
287372|NCT01280604|P1|Participant Flow|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
287373|NCT01280604|O2|Outcome|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
287374|NCT01280604|O1|Outcome|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
287375|NCT01280604|O2|Outcome|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
287376|NCT01280604|O1|Outcome|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
287377|NCT01280604|O2|Outcome|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
287378|NCT01280604|O1|Outcome|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
287379|NCT01280604|O2|Outcome|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
287380|NCT01280604|O1|Outcome|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
287381|NCT01280604|O2|Outcome|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
287382|NCT01280604|O1|Outcome|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
287383|NCT01280604|O2|Outcome|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
287384|NCT01280604|O1|Outcome|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
287385|NCT01280604|E2|Reported Event|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
287386|NCT01280604|E1|Reported Event|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
287387|NCT01280591|B5|Baseline|Total|Total of all reporting groups
287388|NCT01280591|B4|Baseline|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
287389|NCT01280591|B3|Baseline|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
287390|NCT01280591|B2|Baseline|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
287391|NCT01280591|B1|Baseline|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
287392|NCT01280591|P4|Participant Flow|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
287393|NCT01280591|P3|Participant Flow|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
287394|NCT01280591|P2|Participant Flow|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
287396|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
287397|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
287398|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
287399|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
287400|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
287401|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
287402|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
287403|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
287404|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
287405|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
287406|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
287407|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
287408|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
287409|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
287410|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
287411|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
287412|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
287413|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
287414|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
287415|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
287416|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
287417|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
287418|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
287419|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
287420|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
287421|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
287422|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
287423|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
287424|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
287425|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
287426|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
287427|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
287428|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
287429|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
287430|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
287431|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
287432|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
287433|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
287434|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
287435|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
287436|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
287437|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
287438|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
287439|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
287440|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
287441|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
287442|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
287443|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
287444|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
287445|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
287446|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
287447|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
287448|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
287449|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
287450|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
287451|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
287452|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
287453|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
287454|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
287455|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
287456|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
287457|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
287458|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
287459|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
287460|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
287461|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
287462|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
287463|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
287464|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
287465|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
287466|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
287467|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
287468|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
287469|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
287470|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
287471|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
287472|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
287473|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
287474|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
287475|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
287476|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
287477|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
287478|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
287479|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
287480|NCT01280591|E4|Reported Event|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
287481|NCT01280591|E3|Reported Event|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
287482|NCT01280591|E2|Reported Event|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
287483|NCT01280591|E1|Reported Event|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
287484|NCT01280552|B3|Baseline|Total|Total of all reporting groups
287485|NCT01280552|B2|Baseline|Placebo|"Autologous dendritic cells that have not been pulsed with antigens~Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
287486|NCT01280552|B1|Baseline|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens~ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
287487|NCT01280552|P2|Participant Flow|Placebo|"Autologous dendritic cells that have not been pulsed with antigens~Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
287488|NCT01280552|P1|Participant Flow|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens~ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
287489|NCT01280552|O2|Outcome|Placebo|"Autologous dendritic cells that have not been pulsed with antigens~Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
287490|NCT01280552|O1|Outcome|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens~ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
287491|NCT01280552|O2|Outcome|Control|"Autologous dendritic cells that have not been pulsed with antigens~Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
287492|NCT01280552|O1|Outcome|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens~ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
287493|NCT01280552|O2|Outcome|Placebo|"Autologous dendritic cells that have not been pulsed with antigens~Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
287494|NCT01280552|O1|Outcome|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens~ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
287495|NCT01280552|O2|Outcome|Control Dendritic Cells|Treatment with autologous dendritic cells not pulsed with immunogenic peptides
287496|NCT01280552|O1|Outcome|ICT-107|Treatment with autologous dendritic cells pulsed with immunogenic peptides
287497|NCT01280552|E2|Reported Event|Placebo|"Autologous dendritic cells that have not been pulsed with antigens~Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
287498|NCT01280552|E1|Reported Event|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens~ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
287499|NCT01280357|B1|Baseline|Monitor With the Philips 50XM, Remove Monica AN24|Intervention required if not confident of AN24 data is to remove the AN24 and continue monitoring with the predicate Tocco device
287500|NCT01280357|P1|Participant Flow|All Participants|during labor & delivery fetal heart rate, maternal heart rate and uterine contractions were monitored simultaneously by the Monia AN24 & the Philips 50XM
287501|NCT01280357|O1|Outcome|All Participants|all participants that had maternal heart rate measured with the Monica AN24 & the Philips 50XM
287502|NCT01280357|O1|Outcome|All Participants|all participants that had fetal heart rate measured with the Monica AN24 & the Philips 50XM
287503|NCT01280357|O1|Outcome|All Participants|Continue monitoring with the Philips 50XM and disconnect the Monica AN24 monitor.
287504|NCT01280357|E2|Reported Event|Monica AN24|Intervention required if not confident of AN24 data is to remove the AN24 and continue monitoring with the Philips 50XM
287505|NCT01280357|E1|Reported Event|Philips 50XM,|Intervention required if not confident of AN24 data is to remove the AN24 and continue monitoring with the Philips 50XM
287506|NCT01280266|B3|Baseline|Total|Total of all reporting groups
287507|NCT01280266|B2|Baseline|Udenafil-Amlodipine (UA) Arm|Udenafil first, then Amlodipine
287508|NCT01280266|B1|Baseline|Amlodipine-Udenafil (AU) Arm|Amlodipine first, then Udenafil
287509|NCT01280266|P2|Participant Flow|Udenafil-Amlodipine (UA) Arm|Udenafil 100mg PO QD for 4 weeks, washout period for 1 week, then Udenafil 10mg PO QD for 4 weeks.
287510|NCT01280266|P1|Participant Flow|Amlodipine-Udenafil (AU) Arm|Amlodipine 10mg PO QD for 4 weeks, washout period for 1week, then Udenafil 100mg PO QD for 4 weeks.
287511|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
287512|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
287513|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
287514|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
287515|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
287516|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
287517|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
287518|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
287519|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
287520|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
287521|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
287522|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
287523|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
287524|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
287525|NCT01280266|O2|Outcome|Udenafil|Changes in RPS during udenafil 10 mg orally per day
287526|NCT01280266|O1|Outcome|Amlodipine|Changes in RPS during amlodipine 100 mg orally per day
287527|NCT01280266|O2|Outcome|Udenafil|Changes in RP attacks per day during udenafil 100mg orally per day
287528|NCT01280266|O1|Outcome|Amlodipine|Changes in RP attacks per day during amlodipine 10 mg orally per day
287529|NCT01280266|E2|Reported Event|Udenafil|Adverse effects observed while taking udenafil in both study arms
287530|NCT01280266|E1|Reported Event|Amlodipine|Adverse effects observed while taking amlodipine in both study arms
287531|NCT01280123|B4|Baseline|Total|Total of all reporting groups
287532|NCT01280123|B3|Baseline|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
287533|NCT01280123|B2|Baseline|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
287534|NCT01280123|B1|Baseline|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
287535|NCT01280123|P3|Participant Flow|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
287536|NCT01280123|P2|Participant Flow|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
287537|NCT01280123|P1|Participant Flow|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
287538|NCT01280123|O3|Outcome|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
287539|NCT01280123|O2|Outcome|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
287540|NCT01280123|O1|Outcome|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
287541|NCT01280123|O3|Outcome|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
287542|NCT01280123|O2|Outcome|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
287543|NCT01280123|O1|Outcome|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
287544|NCT01280123|O3|Outcome|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
287545|NCT01280123|O2|Outcome|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
287566|NCT01280110|O2|Outcome|Preservative-free Lubricating Drops|he second group will receive preservative-free lubricating drops 4 times a day for 1 month. The flare will be evaluated with Laser Flare Cell Meter (Kowa, FM 500, Japan). The patients will have 3 evaluations (baseline, 15 days and 30 days). The baseline measure is done before the use of the eyedrops.
287546|NCT01280123|O1|Outcome|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
287547|NCT01280123|O3|Outcome|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
287548|NCT01280123|O2|Outcome|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
287549|NCT01280123|O1|Outcome|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
287550|NCT01280123|O3|Outcome|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
287551|NCT01280123|O2|Outcome|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
287552|NCT01280123|O1|Outcome|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
287553|NCT01280123|O3|Outcome|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
287554|NCT01280123|O2|Outcome|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
287555|NCT01280123|O1|Outcome|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
287556|NCT01280123|E3|Reported Event|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
287557|NCT01280123|E2|Reported Event|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
287558|NCT01280123|E1|Reported Event|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
287559|NCT01280110|B3|Baseline|Total|Total of all reporting groups
287560|NCT01280110|B2|Baseline|Preservative-free Lubricating Drops|The second group will receive preservative-free lubricating drops 4 times a day for 1 month.
287561|NCT01280110|B1|Baseline|Preserved (BAK 0.006%) Lubricating Drop|One group will receive preserved lubricating drops 4 times a day for 1 month.
287562|NCT01280110|P2|Participant Flow|Preservative-free Lubricating Drops|The second group will receive preservative-free lubricating drops 4 times a day for 1 month.
287563|NCT01280110|P1|Participant Flow|Preserved (BAK 0.006%) Lubricating Drop|One group will receive preserved lubricating drops 4 times a day for 1 month.
287564|NCT01280110|O2|Outcome|Preservative-free Lubricating Drops|The second group will receive preservative-free lubricating drops 4 times a day for 1 month. The central macular thickness was obtained through Cirrus™ HD-OCT (Zeiss). Mode 512x128 macular cube scan
287565|NCT01280110|O1|Outcome|Preserved (BAK 0.006%) Lubricating Drop|One group will receive preserved lubricating drops 4 times a day for 1 month. The central macular thickness was obtained through Cirrus™ HD-OCT (Zeiss). Mode 512x128 macular cube scan
287567|NCT01280110|O1|Outcome|Preserved (BAK 0.006%) Lubricating Drop|One group will receive preserved lubricating drops 4 times a day for 1 month. The flare will be evaluated with Laser Flare Cell Meter (Kowa, FM 500, Japan). The patients will have 3 evaluations (baseline, 15 days and 30 days). The baseline measure is done before the use of the eyedrops.
287568|NCT01280110|E2|Reported Event|Preservative-free Lubricating Drops|The second group will receive preservative-free lubricating drops 4 times a day for 1 month.
287569|NCT01280110|E1|Reported Event|Preserved (BAK 0.006%) Lubricating Drop|One group will receive preserved lubricating drops 4 times a day for 1 month.
287570|NCT01280058|B3|Baseline|Total|Total of all reporting groups
287571|NCT01280058|B2|Baseline|Arm B (Carboplatin, Paclitaxel)|"Patients receive paclitaxel and carboplatin as in Arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV"
287572|NCT01280058|B1|Baseline|Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Wild-type Reovirus: Given IV"
287573|NCT01280058|P2|Participant Flow|Arm B (Carboplatin, Paclitaxel)|"Patients receive paclitaxel and carboplatin as in Arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV"
287574|NCT01280058|P1|Participant Flow|Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Wild-type Reovirus: Given IV"
287575|NCT01280058|O2|Outcome|Arm B (Carboplatin, Paclitaxel)|"Patients receive paclitaxel and carboplatin as in Arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV"
287576|NCT01280058|O1|Outcome|Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Wild-type Reovirus: Given IV"
287577|NCT01280058|O2|Outcome|Arm II (Carboplatin, Paclitaxel)|"Patients receive paclitaxel and carboplatin as in Arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV"
287578|NCT01280058|O1|Outcome|Arm I (Wild-type Reovirus, Carboplatin, Paclitaxel)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Wild-type Reovirus: Given IV"
287579|NCT01280058|O2|Outcome|Arm B (Carboplatin, Paclitaxel)|"Patients receive paclitaxel and carboplatin as in Arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV"
287580|NCT01280058|O1|Outcome|Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Wild-type Reovirus: Given IV"
287581|NCT01280058|O2|Outcome|Arm B (Carboplatin, Paclitaxel)|"Patients receive paclitaxel and carboplatin as in Arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV"
287582|NCT01280058|O1|Outcome|Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Wild-type Reovirus: Given IV"
287583|NCT01280058|O2|Outcome|Arm B (Carboplatin, Paclitaxel)|"Patients receive paclitaxel and carboplatin as in Arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV"
287584|NCT01280058|O1|Outcome|Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Wild-type Reovirus: Given IV"
287585|NCT01280058|O2|Outcome|Arm B (Carboplatin, Paclitaxel)|"Patients receive paclitaxel and carboplatin as in Arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV"
287586|NCT01280058|O1|Outcome|Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Wild-type Reovirus: Given IV"
287641|NCT01279200|B3|Baseline|Total|Total of all reporting groups
288123|NCT01277601|O3|Outcome|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
287587|NCT01280058|E2|Reported Event|Arm B (Carboplatin, Paclitaxel)|Patients receive paclitaxel and carboplatin as in Arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I. Carboplatin and Paclitaxel were given IV
287588|NCT01280058|E1|Reported Event|Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel)|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Carboplatin and Paclitaxel were given IV. Wild-type Reovirus: Given IV
287589|NCT01279681|B3|Baseline|Total|Total of all reporting groups
287590|NCT01279681|B2|Baseline|Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV]|Patients receive either mFOLFOX7 plus BEV, or Capecitabine + OXAL (XELOX) plus BEV. mFOLFOX7 + BEV is comprised of OXAL IV over 2 hours, LV calcium IV over 2 hours, and 5FU IV over 46-48 hours on day 1. Patients also receive BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. XELOX + BEV is comprised of OXAL IV over 2 hours on day 1 and capecitabine PO BID on days 1-14. Patients also receive BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287591|NCT01279681|B1|Baseline|Arm A [Fluoropyrimidine + Bevacizumab (BEV)]|Patients receive either 5FU/LV or Capecitabine, plus BEV. 5FU/LV + BEV is comprised of 5FU IV over 46-48 hours, LV calcium IV over 2 hours, and BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Capecitabine + BEV is comprised of capecitabine PO BID on days 1-14 and BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287592|NCT01279681|P2|Participant Flow|Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV]|Patients receive either mFOLFOX7 plus BEV, or Capecitabine + OXAL (XELOX) plus BEV. mFOLFOX7 + BEV is comprised of OXAL IV over 2 hours, LV calcium IV over 2 hours, and 5FU IV over 46-48 hours on day 1. Patients also receive BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. XELOX + BEV is comprised of OXAL IV over 2 hours on day 1 and capecitabine PO BID on days 1-14. Patients also receive BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287593|NCT01279681|P1|Participant Flow|Arm A [Fluoropyrimidine + Bevacizumab (BEV)]|Patients receive either 5FU/LV or Capecitabine, plus BEV. 5FU/LV + BEV is comprised of 5FU IV over 46-48 hours, LV calcium IV over 2 hours, and BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Capecitabine + BEV is comprised of capecitabine PO BID on days 1-14 and BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287594|NCT01279681|O2|Outcome|Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV]|Patients receive either mFOLFOX7 plus BEV, or Capecitabine + OXAL (XELOX) plus BEV. mFOLFOX7 + BEV is comprised of OXAL IV over 2 hours, LV calcium IV over 2 hours, and 5FU IV over 46-48 hours on day 1. Patients also receive BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. XELOX + BEV is comprised of OXAL IV over 2 hours on day 1 and capecitabine PO BID on days 1-14. Patients also receive BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287595|NCT01279681|O1|Outcome|Arm A [Fluoropyrimidine + Bevacizumab (BEV)]|Patients receive either 5FU/LV or Capecitabine, plus BEV. 5FU/LV + BEV is comprised of 5FU IV over 46-48 hours, LV calcium IV over 2 hours, and BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Capecitabine + BEV is comprised of capecitabine PO BID on days 1-14 and BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287596|NCT01279681|O2|Outcome|Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV]|Patients receive either mFOLFOX7 plus BEV, or Capecitabine + OXAL (XELOX) plus BEV. mFOLFOX7 + BEV is comprised of OXAL IV over 2 hours, LV calcium IV over 2 hours, and 5FU IV over 46-48 hours on day 1. Patients also receive BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. XELOX + BEV is comprised of OXAL IV over 2 hours on day 1 and capecitabine PO BID on days 1-14. Patients also receive BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287597|NCT01279681|O1|Outcome|Arm A [Fluoropyrimidine + Bevacizumab (BEV)]|Patients receive either 5FU/LV or Capecitabine, plus BEV. 5FU/LV + BEV is comprised of 5FU IV over 46-48 hours, LV calcium IV over 2 hours, and BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Capecitabine + BEV is comprised of capecitabine PO BID on days 1-14 and BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287598|NCT01279681|O2|Outcome|Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV]|Patients receive either mFOLFOX7 plus BEV, or Capecitabine + OXAL (XELOX) plus BEV. mFOLFOX7 + BEV is comprised of OXAL IV over 2 hours, LV calcium IV over 2 hours, and 5FU IV over 46-48 hours on day 1. Patients also receive BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. XELOX + BEV is comprised of OXAL IV over 2 hours on day 1 and capecitabine PO BID on days 1-14. Patients also receive BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287599|NCT01279681|O1|Outcome|Arm A [Fluoropyrimidine + Bevacizumab (BEV)]|Patients receive either 5FU/LV or Capecitabine, plus BEV. 5FU/LV + BEV is comprised of 5FU IV over 46-48 hours, LV calcium IV over 2 hours, and BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Capecitabine + BEV is comprised of capecitabine PO BID on days 1-14 and BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287600|NCT01279681|O2|Outcome|Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV]|Patients receive either mFOLFOX7 plus BEV, or Capecitabine + OXAL (XELOX) plus BEV. mFOLFOX7 + BEV is comprised of OXAL IV over 2 hours, LV calcium IV over 2 hours, and 5FU IV over 46-48 hours on day 1. Patients also receive BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. XELOX + BEV is comprised of OXAL IV over 2 hours on day 1 and capecitabine PO BID on days 1-14. Patients also receive BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287601|NCT01279681|O1|Outcome|Arm A [Fluoropyrimidine + Bevacizumab (BEV)]|Patients receive either 5FU/LV or Capecitabine, plus BEV. 5FU/LV + BEV is comprised of 5FU IV over 46-48 hours, LV calcium IV over 2 hours, and BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Capecitabine + BEV is comprised of capecitabine PO BID on days 1-14 and BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287602|NCT01279681|E2|Reported Event|Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV]|Patients receive either mFOLFOX7 plus BEV, or Capecitabine + OXAL (XELOX) plus BEV. mFOLFOX7 + BEV is comprised of OXAL IV over 2 hours, LV calcium IV over 2 hours, and 5FU IV over 46-48 hours on day 1. Patients also receive BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. XELOX + BEV is comprised of OXAL IV over 2 hours on day 1 and capecitabine PO BID on days 1-14. Patients also receive BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287603|NCT01279681|E1|Reported Event|Arm A [Fluoropyrimidine + Bevacizumab (BEV)]|Patients receive either 5FU/LV or Capecitabine, plus BEV. 5FU/LV + BEV is comprised of 5FU IV over 46-48 hours, LV calcium IV over 2 hours, and BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Capecitabine + BEV is comprised of capecitabine PO BID on days 1-14 and BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287604|NCT01279564|B3|Baseline|Total|Total of all reporting groups
287605|NCT01279564|B2|Baseline|Control|"Intubation~Endotracheal tube: Intubation"
287606|NCT01279564|B1|Baseline|ETview|"Endotracheal intubation with ETview TVT~ETview TVT endotracheal tube: intubation"
287607|NCT01279564|P2|Participant Flow|Control|"Intubation~Endotracheal tube- standard"
287608|NCT01279564|P1|Participant Flow|ETview|"Endotracheal intubation with ETview TVT~ETview TVT endotracheal tube: intubation"
287609|NCT01279564|O2|Outcome|Control|"Intubation~Duration of intubation"
287610|NCT01279564|O1|Outcome|ETview|"Endotracheal intubation with ETview TVT~Duration of intubation"
287611|NCT01279564|E2|Reported Event|Control|"Intubation~Endotracheal tube: Intubation~No adverse events"
287612|NCT01279564|E1|Reported Event|ETview|"Endotracheal intubation with ETview TVT~ETview TVT endotracheal tube: intubation~No adverse events"
287613|NCT01279447|B3|Baseline|Total|Total of all reporting groups
287614|NCT01279447|B2|Baseline|Infrapatellar Nerve Block|"An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine~0.25% Bupivacaine: 10cc, single dose, US guided injection"
287615|NCT01279447|B1|Baseline|Placebo|"A sham infrapatellar block performed under US guidance with normal saline~Normal Saline: 10cc, single dose, US guided injection"
287616|NCT01279447|P2|Participant Flow|Infrapatellar Nerve Block|"An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine~0.25% Bupivacaine: 10cc, single dose, US guided injection"
287617|NCT01279447|P1|Participant Flow|Placebo|"A sham infrapatellar block performed under US guidance with normal saline~Normal Saline: 10cc, single dose, US guided injection"
287618|NCT01279447|O2|Outcome|Infrapatellar Nerve Block|"An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine~0.25% Bupivacaine: 10cc, single dose, US guided injection"
287619|NCT01279447|O1|Outcome|Placebo|"A sham infrapatellar block performed under US guidance with normal saline~Normal Saline: 10cc, single dose, US guided injection"
287620|NCT01279447|E2|Reported Event|Infrapatellar Nerve Block|"An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine~0.25% Bupivacaine: 10cc, single dose, US guided injection"
287621|NCT01279447|E1|Reported Event|Placebo|"A sham infrapatellar block performed under US guidance with normal saline~Normal Saline: 10cc, single dose, US guided injection"
287622|NCT01279317|B1|Baseline|Vinegar Co-ingestion|All participants performed both intervention periods.
287623|NCT01279317|P2|Participant Flow|Placebo Co-ingestion First, Then Vinegar Co-ingestion|First acute experiment with placebo-coingestion (1 day), after 1 week washout experiment with vinegar co-ingestion (1 day).
287624|NCT01279317|P1|Participant Flow|Vinegar Co-ingestion First, Then Placebo Co-intestion|First acute experiment with vinegar-coingestion (1 day), after 1 week washout, experiment with placebo co-ingestion (1 day).
287625|NCT01279317|O2|Outcome|Placebo Co-ingestion|
287626|NCT01279317|O1|Outcome|Vinegar Co-ingestion|
287627|NCT01279317|E1|Reported Event|Vinegar Co-ingestion|All participants performed both intervention periods.
287628|NCT01279265|B3|Baseline|Total|Total of all reporting groups
287629|NCT01279265|B2|Baseline|Nutramigen A+|"Hypoallergenic formula without lactobacilli~Nutramigen A+: Hypoallergenic formula without lactobacillus"
287630|NCT01279265|B1|Baseline|Nutramigen Lipil With Enflora|Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG
287631|NCT01279265|P2|Participant Flow|Nutramigen A+|"Hypoallergenic formula without lactobacilli~Nutramigen A+: Hypoallergenic formula without lactobacillus"
287632|NCT01279265|P1|Participant Flow|Nutramigen Lipil With Enflora|Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG
287633|NCT01279265|O2|Outcome|Nutramigen A+|"Hypoallergenic formula without probiotics (Lactobaccillus Rhamnosus GG)~Nutramigen A+: Hypoallergenic formula without lactobacillus"
287634|NCT01279265|O1|Outcome|Nutramigen Lipil With Enflora|"Formula with probiotics (Lactobaccillus Rhamnosus GG)~Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG"
287635|NCT01279265|O2|Outcome|Nutramigen A+|"Hypoallergenic formula without lactobacilli~Nutramigen A+: Hypoallergenic formula without lactobacillus"
287636|NCT01279265|O1|Outcome|Nutramigen Lipil With Enflora|Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG
287637|NCT01279265|O2|Outcome|Nutramigen A+|"Hypoallergenic formula without lactobacilli~Nutramigen A+: Hypoallergenic formula without lactobacillus"
287638|NCT01279265|O1|Outcome|Nutramigen Lipil With Enflora|Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG
287639|NCT01279265|E2|Reported Event|Nutramigen A+|"Hypoallergenic formula without lactobacilli~Nutramigen A+: Hypoallergenic formula without lactobacillus"
287640|NCT01279265|E1|Reported Event|Nutramigen Lipil With Enflora|Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG
287642|NCT01279200|B2|Baseline|Midcycle Ultrasound + hCG Injection|"Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.~Midcycle ultrasound + hCG injection: Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate."
287643|NCT01279200|B1|Baseline|Urinary LH Kits|"Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).~Urinary LH kits: Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination."
287644|NCT01279200|P2|Participant Flow|Midcycle Ultrasound + hCG Injection|"Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.~Midcycle ultrasound + hCG injection: Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate."
287645|NCT01279200|P1|Participant Flow|Urinary LH Kits|"Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).~Urinary LH kits: Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination."
287646|NCT01279200|O2|Outcome|Midcycle Ultrasound + hCG Injection|"Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.~Midcycle ultrasound + hCG injection: Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate."
287647|NCT01279200|O1|Outcome|Urinary LH Kits|"Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).~Urinary LH kits: Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination."
287648|NCT01279200|O2|Outcome|Midcycle Ultrasound + hCG Injection|"Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.~Midcycle ultrasound + hCG injection: Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate."
287649|NCT01279200|O1|Outcome|Urinary LH Kits|"Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).~Urinary LH kits: Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination."
287650|NCT01279200|E2|Reported Event|Midcycle Ultrasound + hCG Injection|"Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.~Midcycle ultrasound + hCG injection: Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate."
287651|NCT01279200|E1|Reported Event|Urinary LH Kits|"Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).~Urinary LH kits: Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination."
287652|NCT01279187|B3|Baseline|Total|Total of all reporting groups
287653|NCT01279187|B2|Baseline|Control|"demeclocycline HCl (150 mg, four times per day for 3d) followed by a 12 day intermission then 3 more days of demeclocycline HCl (150 mg, four times per day). One day after the last demeclocycline dosage, subjects will be instructed to self-administer teriparatide (or placebo) for 7 weeks. Twenty-five days after the last demeclocycline dosage, subjects will begin their second set of tetracycline labels:(250 mg, four times per day) for three days, followed by 12 days off, and then repeat another 3 days of tetracycline HCl (250 mg, four times per day). On day of the last teriparatide (or placebo) injection, subjects will present for bone core removal and dental implant placement.~Placebo: 20ug per day, self administered injection, for 7 weeks"
287654|NCT01279187|B1|Baseline|Teriparatide|"demeclocycline HCl (150 mg, four times per day for 3d) followed by a 12 day intermission then 3 more days of demeclocycline HCl (150 mg, four times per day). One day after the last demeclocycline dosage, subjects will be instructed to self-administer teriparatide (or placebo) for 7 weeks. Twenty-five days after the last demeclocycline dosage, subjects will begin their second set of tetracycline labels:(250 mg, four times per day) for three days, followed by 12 days off, and then repeat another 3 days of tetracycline HCl (250 mg, four times per day). On day of the last teriparatide (or placebo) injection, subjects will present for bone core removal and dental implant placement.~Teriparatide: 20ug per day,via subcutaneous injection, for 7 weeks"
287655|NCT01279187|P2|Participant Flow|Control|"demeclocycline HCl (150 mg, four times per day for 3d) followed by a 12 day intermission then 3 more days of demeclocycline HCl (150 mg, four times per day). One day after the last demeclocycline dosage, subjects will be instructed to self-administer teriparatide (or placebo) for 7 weeks. Twenty-five days after the last demeclocycline dosage, subjects will begin their second set of tetracycline labels:(250 mg, four times per day) for three days, followed by 12 days off, and then repeat another 3 days of tetracycline HCl (250 mg, four times per day). On day of the last teriparatide (or placebo) injection, subjects will present for bone core removal and dental implant placement.~Placebo: 20ug per day, self administered injection, for 7 weeks"
287656|NCT01279187|P1|Participant Flow|Teriparatide|"demeclocycline HCl (150 mg, four times per day for 3d) followed by a 12 day intermission then 3 more days of demeclocycline HCl (150 mg, four times per day). One day after the last demeclocycline dosage, subjects will be instructed to self-administer teriparatide (or placebo) for 7 weeks. Twenty-five days after the last demeclocycline dosage, subjects will begin their second set of tetracycline labels:(250 mg, four times per day) for three days, followed by 12 days off, and then repeat another 3 days of tetracycline HCl (250 mg, four times per day). On day of the last teriparatide (or placebo) injection, subjects will present for bone core removal and dental implant placement.~Teriparatide: 20ug per day,via subcutaneous injection, for 7 weeks"
287693|NCT01279070|O2|Outcome|Leisure & Socialization Group|"Parallel to the experimental group, a leisure group was established (control group) which participated in 32 stimulating and socializing activities (e.g., card games, board games, coffee & talk, geography review, etc)."
288124|NCT01277601|O2|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks
326795|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
287657|NCT01279187|O2|Outcome|Control|"demeclocycline HCl (150 mg, four times per day for 3d) followed by a 12 day intermission then 3 more days of demeclocycline HCl (150 mg, four times per day). One day after the last demeclocycline dosage, subjects will be instructed to self-administer teriparatide (or placebo) for 7 weeks. Twenty-five days after the last demeclocycline dosage, subjects will begin their second set of tetracycline labels:(250 mg, four times per day) for three days, followed by 12 days off, and then repeat another 3 days of tetracycline HCl (250 mg, four times per day). On day of the last teriparatide (or placebo) injection, subjects will present for bone core removal and dental implant placement.~Placebo: 20ug per day, self administered injection, for 7 weeks"
287658|NCT01279187|O1|Outcome|Teriparatide|"demeclocycline HCl (150 mg, four times per day for 3d) followed by a 12 day intermission then 3 more days of demeclocycline HCl (150 mg, four times per day). One day after the last demeclocycline dosage, subjects will be instructed to self-administer teriparatide (or placebo) for 7 weeks. Twenty-five days after the last demeclocycline dosage, subjects will begin their second set of tetracycline labels:(250 mg, four times per day) for three days, followed by 12 days off, and then repeat another 3 days of tetracycline HCl (250 mg, four times per day). On day of the last teriparatide (or placebo) injection, subjects will present for bone core removal and dental implant placement.~Teriparatide: 20ug per day,via subcutaneous injection, for 7 weeks"
287659|NCT01279187|O2|Outcome|Control|"demeclocycline HCl (150 mg, four times per day for 3d) followed by a 12 day intermission then 3 more days of demeclocycline HCl (150 mg, four times per day). One day after the last demeclocycline dosage, subjects will be instructed to self-administer teriparatide (or placebo) for 7 weeks. Twenty-five days after the last demeclocycline dosage, subjects will begin their second set of tetracycline labels:(250 mg, four times per day) for three days, followed by 12 days off, and then repeat another 3 days of tetracycline HCl (250 mg, four times per day). On day of the last teriparatide (or placebo) injection, subjects will present for bone core removal and dental implant placement.~Placebo: 20ug per day, self administered injection, for 7 weeks"
287660|NCT01279187|O1|Outcome|Teriparatide|"demeclocycline HCl (150 mg, four times per day for 3d) followed by a 12 day intermission then 3 more days of demeclocycline HCl (150 mg, four times per day). One day after the last demeclocycline dosage, subjects will be instructed to self-administer teriparatide (or placebo) for 7 weeks. Twenty-five days after the last demeclocycline dosage, subjects will begin their second set of tetracycline labels:(250 mg, four times per day) for three days, followed by 12 days off, and then repeat another 3 days of tetracycline HCl (250 mg, four times per day). On day of the last teriparatide (or placebo) injection, subjects will present for bone core removal and dental implant placement.~Teriparatide: 20ug per day,via subcutaneous injection, for 7 weeks"
287661|NCT01279187|O2|Outcome|Control|"demeclocycline HCl (150 mg, four times per day for 3d) followed by a 12 day intermission then 3 more days of demeclocycline HCl (150 mg, four times per day). One day after the last demeclocycline dosage, subjects will be instructed to self-administer teriparatide (or placebo) for 7 weeks. Twenty-five days after the last demeclocycline dosage, subjects will begin their second set of tetracycline labels:(250 mg, four times per day) for three days, followed by 12 days off, and then repeat another 3 days of tetracycline HCl (250 mg, four times per day). On day of the last teriparatide (or placebo) injection, subjects will present for bone core removal and dental implant placement.~Placebo: 20ug per day, self administered injection, for 7 weeks"
287662|NCT01279187|O1|Outcome|Teriparatide|"demeclocycline HCl (150 mg, four times per day for 3d) followed by a 12 day intermission then 3 more days of demeclocycline HCl (150 mg, four times per day). One day after the last demeclocycline dosage, subjects will be instructed to self-administer teriparatide (or placebo) for 7 weeks. Twenty-five days after the last demeclocycline dosage, subjects will begin their second set of tetracycline labels:(250 mg, four times per day) for three days, followed by 12 days off, and then repeat another 3 days of tetracycline HCl (250 mg, four times per day). On day of the last teriparatide (or placebo) injection, subjects will present for bone core removal and dental implant placement.~Teriparatide: 20ug per day,via subcutaneous injection, for 7 weeks"
287663|NCT01279187|O2|Outcome|Control|"demeclocycline HCl (150 mg, four times per day for 3d) followed by a 12 day intermission then 3 more days of demeclocycline HCl (150 mg, four times per day). One day after the last demeclocycline dosage, subjects will be instructed to self-administer teriparatide (or placebo) for 7 weeks. Twenty-five days after the last demeclocycline dosage, subjects will begin their second set of tetracycline labels:(250 mg, four times per day) for three days, followed by 12 days off, and then repeat another 3 days of tetracycline HCl (250 mg, four times per day). On day of the last teriparatide (or placebo) injection, subjects will present for bone core removal and dental implant placement.~Placebo: 20ug per day, self administered injection, for 7 weeks"
287664|NCT01279187|O1|Outcome|Teriparatide|"demeclocycline HCl (150 mg, four times per day for 3d) followed by a 12 day intermission then 3 more days of demeclocycline HCl (150 mg, four times per day). One day after the last demeclocycline dosage, subjects will be instructed to self-administer teriparatide (or placebo) for 7 weeks. Twenty-five days after the last demeclocycline dosage, subjects will begin their second set of tetracycline labels:(250 mg, four times per day) for three days, followed by 12 days off, and then repeat another 3 days of tetracycline HCl (250 mg, four times per day). On day of the last teriparatide (or placebo) injection, subjects will present for bone core removal and dental implant placement.~Teriparatide: 20ug per day,via subcutaneous injection, for 7 weeks"
287665|NCT01279187|O2|Outcome|Control|"demeclocycline HCl (150 mg, four times per day for 3d) followed by a 12 day intermission then 3 more days of demeclocycline HCl (150 mg, four times per day). One day after the last demeclocycline dosage, subjects will be instructed to self-administer teriparatide (or placebo) for 7 weeks. Twenty-five days after the last demeclocycline dosage, subjects will begin their second set of tetracycline labels:(250 mg, four times per day) for three days, followed by 12 days off, and then repeat another 3 days of tetracycline HCl (250 mg, four times per day). On day of the last teriparatide (or placebo) injection, subjects will present for bone core removal and dental implant placement.~Placebo: 20ug per day, self administered injection, for 7 weeks"
287717|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
287718|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
326796|NCT01181011|E3|Reported Event|Amlodipine 5mg|
287666|NCT01279187|O1|Outcome|Teriparatide|"demeclocycline HCl (150 mg, four times per day for 3d) followed by a 12 day intermission then 3 more days of demeclocycline HCl (150 mg, four times per day). One day after the last demeclocycline dosage, subjects will be instructed to self-administer teriparatide (or placebo) for 7 weeks. Twenty-five days after the last demeclocycline dosage, subjects will begin their second set of tetracycline labels:(250 mg, four times per day) for three days, followed by 12 days off, and then repeat another 3 days of tetracycline HCl (250 mg, four times per day). On day of the last teriparatide (or placebo) injection, subjects will present for bone core removal and dental implant placement.~Teriparatide: 20ug per day,via subcutaneous injection, for 7 weeks"
287667|NCT01279187|E2|Reported Event|Control|"demeclocycline HCl (150 mg, four times per day for 3d) followed by a 12 day intermission then 3 more days of demeclocycline HCl (150 mg, four times per day). One day after the last demeclocycline dosage, subjects will be instructed to self-administer teriparatide (or placebo) for 7 weeks. Twenty-five days after the last demeclocycline dosage, subjects will begin their second set of tetracycline labels:(250 mg, four times per day) for three days, followed by 12 days off, and then repeat another 3 days of tetracycline HCl (250 mg, four times per day). On day of the last teriparatide (or placebo) injection, subjects will present for bone core removal and dental implant placement.~Placebo: 20ug per day, self administered injection, for 7 weeks"
287668|NCT01279187|E1|Reported Event|Teriparatide|"demeclocycline HCl (150 mg, four times per day for 3d) followed by a 12 day intermission then 3 more days of demeclocycline HCl (150 mg, four times per day). One day after the last demeclocycline dosage, subjects will be instructed to self-administer teriparatide (or placebo) for 7 weeks. Twenty-five days after the last demeclocycline dosage, subjects will begin their second set of tetracycline labels:(250 mg, four times per day) for three days, followed by 12 days off, and then repeat another 3 days of tetracycline HCl (250 mg, four times per day). On day of the last teriparatide (or placebo) injection, subjects will present for bone core removal and dental implant placement.~Teriparatide: 20ug per day,via subcutaneous injection, for 7 weeks"
287669|NCT01279109|B3|Baseline|Total|Total of all reporting groups
287670|NCT01279109|B2|Baseline|Home Visit|"Home visits focused on preventable infant injuries~Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention"
287671|NCT01279109|B1|Baseline|Social Network Building Intervention|"Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members~Social network building intervention: Group support and 12 weekly health education/skills building sessions during pregnancy"
287672|NCT01279109|P2|Participant Flow|Home Visit|"Home visits focused on preventable infant injuries~Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention"
287673|NCT01279109|P1|Participant Flow|Social Network Building Intervention|"Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members~Social network building intervention: Group support and 12 weekly health education/skills building sessions during pregnancy"
287674|NCT01279109|O2|Outcome|Home Visit|"Home visits focused on preventable infant injuries~Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention"
287675|NCT01279109|O1|Outcome|Social Network Building Intervention|"Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members~Social network building intervention: Group support and 12 weekly health education/skills building sessions during pregnancy"
287676|NCT01279109|O2|Outcome|Home Visit|"Home visits focused on preventable infant injuries~Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention"
287677|NCT01279109|O1|Outcome|Social Network Building Intervention|"Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members~Social network building intervention: Group support and 12 weekly health education/skills building sessions during pregnancy"
287678|NCT01279109|E2|Reported Event|Home Visit|"Home visits focused on preventable infant injuries~Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention"
287679|NCT01279109|E1|Reported Event|Social Network Building Intervention|"Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members~Social network building intervention: Group support and 12 weekly health education/skills building sessions during pregnancy"
287680|NCT01279070|B3|Baseline|Total|Total of all reporting groups
287681|NCT01279070|B2|Baseline|Repyflec Training|Cognitive remediation treatment
287682|NCT01279070|B1|Baseline|Leisure Group|Leisure group has got same number of sessions and timing than experimental group
287683|NCT01279070|P2|Participant Flow|Leisure Group (Control Group)|"Leisure group~Parallel to the experimental group, a leisure control group was established which participated in 32 stimulating and socializing activities (e.g., card games, board games, coffee & talk, etc.) over 4 months twice a week and lasting 1 h."
287684|NCT01279070|P1|Participant Flow|Experimental Group (Repyflec Cognitive Remediation)|"Cognitive remediation (CR) group training (Repyflec)~REPYFLEC CR is a strategy-based training that targets executive function and metacognition. It is carried out using paper and pencil and a blackboard (required to develop some of the tasks, explanations,examples, etc.); in a group format (4-6 participants), over 4 months twice a week and consisting of 32 sessions lasting 1 h. We developed a Spanish manual where training is described session by session; incorporating the materials for developing sessions, some theoretical points and bibliography for therapists. Working contents are divided into two main areas: Problem Solving (PS) and Cognitive Flexibility (CF)."
287685|NCT01279070|O2|Outcome|Leisure Group|Leisure group has got same number of sessions and timing than experimental group
287686|NCT01279070|O1|Outcome|Repyflec Training|Cognitive remediation treatment
287687|NCT01279070|O2|Outcome|Leisure Group|Leisure group has got same number of sessions and timing than experimental group
287688|NCT01279070|O1|Outcome|Repyflec Training|Cognitive remediation treatment
287689|NCT01279070|O2|Outcome|Leisure Group|Leisure group has got same number of sessions and timing than experimental group
287690|NCT01279070|O1|Outcome|Repyflec Training|Cognitive remediation treatment
287691|NCT01279070|O2|Outcome|Leisure Group|Leisure group has got same number of sessions and timing than experimental group
287692|NCT01279070|O1|Outcome|Repyflec Training|Cognitive remediation treatment
287694|NCT01279070|O1|Outcome|REPYFLEC Cognitive Group Trainining|"REPYFLEC is a strategy-based training, explicitly described from session to session, which is carried out using pencil and paper with a blackboard as visual support. This format allows results to be replicated with rigour. The working content is divided into two principal areas: Problem solving (PS) and Cognitive Flexibility (CF). In the PS block, training in executive function, the thinking process and self-monitoring was emphasized. In the CF block, the tasks require the use of cognitive flexibility for successful completion. Some activities seek to promote training of other functions such as memory, working memory, sustained attention and language. Development of training was performed taking into account the contextual bases of learning, mainly using techniques as modelling to foster coping abilities, molding, self-monitoring, errorless learning and Socratic questioning. REPYFLEC is carried out in a group format (4-6), consisting of 32 sessions lasting 1 hour."
287695|NCT01279070|O2|Outcome|Leisure & Socialization Group|"The leisure group consists in 32 stimulating and socializing group activities (e.g., card games, board games, coffee & talk, geography review, etc.)without specific goals."
287696|NCT01279070|O1|Outcome|REPYFLEC Cognitive Remediation Group Training|REPYFLEC CR is a strategy-based training that targets executive function and metacognition. It is carried out using paper and pencil and a blackboard (required to develop some of the tasks, explanations, examples, etc.); in a group format (4-6 participants), over 4 months twice a week and consisting of 32 sessions lasting 1 h. We developed a Spanish manual where training is described session by session; incorporating the materials for developing sessions, some theoretical points and bibliography for therapists. Working contents are divided into two main areas: Problem Solving (PS) and Cognitive Flexibility (CF). In the PS module (16 sessions), training in executive function,thinking processes and self-monitoring was emphasized.In the CF module (16 sessions), all the tasks require practice of cognitive flexibility combined with other executive abilities such as planning or self-monitoring.
287697|NCT01279070|E2|Reported Event|Repyflec Training|Cognitive remediation group treatment based on Problem Solving and Cognitive Flexibility
287698|NCT01279070|E1|Reported Event|Leisure Group|Stimulating activities without specific goals and focused on leisure
287699|NCT01279044|B4|Baseline|Total|Total of all reporting groups
287700|NCT01279044|B3|Baseline|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
287701|NCT01279044|B2|Baseline|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
287702|NCT01279044|B1|Baseline|Phase 1 - Formative Research|Formative research through individual interviews and pilot testing to develop and adapt the key elements of Personal Cognitive Counseling
287703|NCT01279044|P3|Participant Flow|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
287704|NCT01279044|P2|Participant Flow|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
287705|NCT01279044|P1|Participant Flow|Formative Phase 1|Individual interviews and pilot testing to develop and adapt key elements of Personal Cognitive Counseling
287706|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
287707|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
287708|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
287709|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
287710|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
287711|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
287712|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
287713|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
287714|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
287715|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
287716|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
288125|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
287719|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
287720|NCT01279044|E2|Reported Event|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
287721|NCT01279044|E1|Reported Event|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
287722|NCT01278953|B3|Baseline|Total|Total of all reporting groups
287723|NCT01278953|B2|Baseline|Control|"Ablation performed using a catheter with no contact force sensing capability~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
287724|NCT01278953|B1|Baseline|TactiCath|"Ablation performed using the TactiCath contact force sensing catheter~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
287725|NCT01278953|P2|Participant Flow|Control|"Ablation performed using a catheter with no contact force sensing capability~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
287726|NCT01278953|P1|Participant Flow|TactiCath|"Ablation performed using the TactiCath contact force sensing catheter~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
287727|NCT01278953|O2|Outcome|Control|"Ablation performed using a catheter with no contact force sensing capability~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
287728|NCT01278953|O1|Outcome|TactiCath|"Ablation performed using the TactiCath contact force sensing catheter~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
287729|NCT01278953|O2|Outcome|Control|"Ablation performed using a catheter with no contact force sensing capability~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
287730|NCT01278953|O1|Outcome|TactiCath|"Ablation performed using the TactiCath contact force sensing catheter~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
287731|NCT01278953|E2|Reported Event|Control|"Ablation performed using a catheter with no contact force sensing capability~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
287732|NCT01278953|E1|Reported Event|TactiCath|"Ablation performed using the TactiCath contact force sensing catheter~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
287733|NCT01278927|B5|Baseline|Total|Total of all reporting groups
287734|NCT01278927|B4|Baseline|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
287735|NCT01278927|B3|Baseline|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
287736|NCT01278927|B2|Baseline|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
287737|NCT01278927|B1|Baseline|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
287738|NCT01278927|P4|Participant Flow|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
287739|NCT01278927|P3|Participant Flow|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
287740|NCT01278927|P2|Participant Flow|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
287741|NCT01278927|P1|Participant Flow|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
287742|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
287743|NCT01278927|O3|Outcome|Exercise and Stress Management|Exercise and Stress Management - Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
287744|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
287745|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
287746|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
287747|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
287748|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
288844|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
287749|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
287750|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
287751|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
287752|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
287753|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
287754|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
287755|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
287756|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
287757|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
287758|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
287759|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
287760|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
287761|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
287762|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
287763|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
287764|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
287765|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
287766|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
287767|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
287768|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
287769|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
287770|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
287771|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
287772|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
287773|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
287774|NCT01278927|E4|Reported Event|Standard Care|"Patients randomized to standard care only will be informed of their assigned condition and receive a digital video disc (DVD). The interventionist will briefly discuss the topics of the DVD and elicit questions. To minimize contamination across intervention conditions, participants randomized to the control group will be provided with only general advice about exercise and stress management during treatment (i.e., to maintain any usual patterns of exercise to the extent possible and to continue using any techniques they currently use to manage stress).~Standard Care: Patients randomized to standard care only will be informed of their assigned condition and receive the DVD."
287775|NCT01278927|E3|Reported Event|Exercise and Stress Management|"Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions. On Day 30 post HCT, the same interventionist will meet with the participant briefly to answer any questions about the interventions, encourage the continued use of the interventions as recommended, and monitor for any adverse reactions. The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant. Whenever possible, the interventionist meeting with the patient at 30 and 60 days should be the same interventionist who previously met with the patient.~Exercise and Stress Management: Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions."
287838|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
287776|NCT01278927|E2|Reported Event|Stress Management|"Participants will receive a packet of materials from the study interventionist, along with a brief standardized introduction to the self-administered intervention. On Day 30 post HCT, the interventionist will meet with the participant to answer any questions about the intervention, encourage the continued use of stress management techniques as recommended, and monitor for any adverse reactions to use of the techniques. The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant. Whenever possible, the interventionist meeting with the patient at 30 and 60 days should be the same interventionist who previously met with the patient.~Stress Management: Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention."
287777|NCT01278927|E1|Reported Event|Exercise|"Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief (10 minute) personalized introduction to the home-based exercise intervention. On Day 30 post hematopoietic cell transplantation (HCT), participants will meet briefly with the same interventionist when possible. To minimize contamination across intervention conditions, participants randomized to Exercise will be provided with only general advice regarding stress management (i.e., to continue using any techniques they currently use to manage stress). The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant.~Exercise: Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention."
287778|NCT01278797|B1|Baseline|Entire Study Population|Includes all subjects randomized to either treatment sequence
287779|NCT01278797|P2|Participant Flow|Telm 80 mg + Amlo 10 mg First, Then Telm/Amlo 80 mg/10 mg|Individual components followed by Combination tablet
287780|NCT01278797|P1|Participant Flow|Telm/Amlo 80 mg/10 mg First, Then Telm 80 mg + Amlo 10 mg|Combination tablet followed by individual components
287781|NCT01278797|O2|Outcome|Telm 80 mg + Amlo 10 mg|Individual tablets
287782|NCT01278797|O1|Outcome|Telm/Amlo 80 mg/10 mg|Combination tablet
287783|NCT01278797|O2|Outcome|Telm 80 mg + Amlo 10 mg|Individual tablets
287784|NCT01278797|O1|Outcome|Telm/Amlo 80 mg/10 mg|Combination tablet
287785|NCT01278797|O2|Outcome|Telm 80 mg + Amlo 10 mg|Individual tablets
287786|NCT01278797|O1|Outcome|Telm/Amlo 80 mg/10 mg|Combination tablet
287787|NCT01278797|E2|Reported Event|Telm 80 mg + Amlo 10 mg|Individual tablets
287788|NCT01278797|E1|Reported Event|Telm/Amlo 80 mg/10 mg|Combination tablet
287789|NCT01278745|B3|Baseline|Total|Total of all reporting groups
287790|NCT01278745|B2|Baseline|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287791|NCT01278745|B1|Baseline|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287792|NCT01278745|P4|Participant Flow|Discontinued Pre-Randomization|Subjects that were enrolled and transplanted on study, but withdrew from the study prior to randomization.
287793|NCT01278745|P3|Participant Flow|Discontinued Pre-Transplant|Subjects that enrolled, but withdrew from the study prior to their transplant.
287794|NCT01278745|P2|Participant Flow|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287795|NCT01278745|P1|Participant Flow|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287839|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
288164|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
287796|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287797|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287798|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287799|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287800|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287801|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287802|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287803|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287840|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
288695|NCT01276509|E2|Reported Event|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
287804|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287805|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287806|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287807|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287808|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287809|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287810|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287811|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287841|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
288696|NCT01276509|E1|Reported Event|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
287812|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287813|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287814|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287815|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287816|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287817|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287818|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287819|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287842|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
288697|NCT01276457|B3|Baseline|Total|Total of all reporting groups
287820|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287821|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287822|NCT01278745|E4|Reported Event|Discontinued Pre-Randomization|Subjects that were enrolled and transplanted on study, but withdrew from the study prior to randomization.
287823|NCT01278745|E3|Reported Event|Discontinued Pre-Transplant|Subjects that enrolled, but withdrew from the study prior to their transplant.
287824|NCT01278745|E2|Reported Event|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287825|NCT01278745|E1|Reported Event|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
287826|NCT01278615|B1|Baseline|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
287827|NCT01278615|P1|Participant Flow|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
287828|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
287829|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
287830|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
287831|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
287832|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
287833|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
287834|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
287835|NCT01278615|E1|Reported Event|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
287836|NCT01278485|B1|Baseline|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
287837|NCT01278485|P1|Participant Flow|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
287843|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
287844|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
287845|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
287846|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
287847|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
287848|NCT01278485|E1|Reported Event|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
287849|NCT01278407|B4|Baseline|Total|Total of all reporting groups
287850|NCT01278407|B3|Baseline|Donepezil 10 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
287851|NCT01278407|B2|Baseline|Donepezil 5 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
287852|NCT01278407|B1|Baseline|Placebo - Confirmatory Phase|Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
287853|NCT01278407|P5|Participant Flow|Donepezil (5 +10 mg) - Extension Phase|Participants previously receiving donepezil (5 mg or 10 mg) up to Week 12 in the Confirmatory Phase, maintained allocated treatment and dosages until Week 24. In the 5 mg group of the Confirmatory Phase, the dose was increased to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
287854|NCT01278407|P4|Participant Flow|Placebo to Donepezil (5 +10 mg) - Extension Phase|Participants previously receiving donepezil matched placebo up to Week 12 in the Confirmatory Phase, continued placebo until Week 16 (at the beginning of the Extension Phase). Participants received 3 mg of donepezil, and the dose was then increased to 5 mg at Week 18 and to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
287855|NCT01278407|P3|Participant Flow|Donepezil 10 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
287856|NCT01278407|P2|Participant Flow|Donepezil 5 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
287857|NCT01278407|P1|Participant Flow|Placebo - Confirmatory Phase|Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
287858|NCT01278407|O3|Outcome|Donepezil 10 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
287859|NCT01278407|O2|Outcome|Donepezil 5 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
287860|NCT01278407|O1|Outcome|Placebo - Confirmatory Phase|Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
287861|NCT01278407|O3|Outcome|Donepezil 10 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
287862|NCT01278407|O2|Outcome|Donepezil 5 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
287863|NCT01278407|O1|Outcome|Placebo - Confirmatory Phase|Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
287864|NCT01278407|E5|Reported Event|Donepezil (5 +10 mg) - Extension Phase|Participants previously receiving donepezil (5 mg or 10 mg) up to Week 12 in the Confirmatory Phase, maintained allocated treatment and dosages until Week 24. In the 5 mg group of the Confirmatory Phase, the dose was increased to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
287865|NCT01278407|E4|Reported Event|Placebo to Donepezil (5 +10 mg) - Extension Phase|Participants previously receiving donepezil matched placebo up to Week 12 in the Confirmatory Phase, continued placebo until Week 16 (at the beginning of the Extension Phase). Participants received 3 mg of donepezil, and the dose was then increased to 5 mg at Week 18 and to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
287866|NCT01278407|E3|Reported Event|Donepezil 10 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
288742|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
287867|NCT01278407|E2|Reported Event|Donepezil 5 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
287868|NCT01278407|E1|Reported Event|Placebo - Confirmatory Phase|Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
287869|NCT01278394|B1|Baseline|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
287870|NCT01278394|P1|Participant Flow|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
287871|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
287872|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
287873|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
287874|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
287875|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
287876|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
287877|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
287878|NCT01278394|E1|Reported Event|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
287879|NCT01278342|B4|Baseline|Total|Total of all reporting groups
287880|NCT01278342|B3|Baseline|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:~1st week: 0.25 mg twice a week (0.50 mg/week)~2nd week: 0.50 mg/week twice a week (1 mg/week)~3rd week: 0.50 mg four times a week (2 mg/week)~4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
287881|NCT01278342|B2|Baseline|Sandostatin LAR High Dose + Pegvisomat|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
287882|NCT01278342|B1|Baseline|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
287883|NCT01278342|P3|Participant Flow|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:~1st week: 0.25 mg twice a week (0.50 mg/week)~2nd week: 0.50 mg/week twice a week (1 mg/week)~3rd week: 0.50 mg four times a week (2 mg/week)~4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
287884|NCT01278342|P2|Participant Flow|Sandostatin LAR High Dose + Pegvisomat|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
287885|NCT01278342|P1|Participant Flow|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
287886|NCT01278342|O3|Outcome|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:~1st week: 0.25 mg twice a week (0.50 mg/week)~2nd week: 0.50 mg/week twice a week (1 mg/week)~3rd week: 0.50 mg four times a week (2 mg/week)~4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
287887|NCT01278342|O2|Outcome|Sandostatin LAR High Dose + Pegvisomat|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
287888|NCT01278342|O1|Outcome|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
287889|NCT01278342|O3|Outcome|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:~1st week: 0.25 mg twice a week (0.50 mg/week)~2nd week: 0.50 mg/week twice a week (1 mg/week)~3rd week: 0.50 mg four times a week (2 mg/week)~4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
287890|NCT01278342|O2|Outcome|Sandostatin LAR High Dose + Pegvisomat|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
287891|NCT01278342|O1|Outcome|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
288835|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
287892|NCT01278342|O3|Outcome|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:~1st week: 0.25 mg twice a week (0.50 mg/week)~2nd week: 0.50 mg/week twice a week (1 mg/week)~3rd week: 0.50 mg four times a week (2 mg/week)~4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
287893|NCT01278342|O2|Outcome|Sandostatin LAR High Dose + Pegvisomat|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
287894|NCT01278342|O1|Outcome|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
287895|NCT01278342|E3|Reported Event|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:~1st week: 0.25 mg twice a week (0.50 mg/week)~2nd week: 0.50 mg/week twice a week (1 mg/week)~3rd week: 0.50 mg four times a week (2 mg/week)~4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
287896|NCT01278342|E2|Reported Event|Sandostatin LAR High Dose + Pegvisomant|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
287897|NCT01278342|E1|Reported Event|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months
287898|NCT01278303|B1|Baseline|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents~Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
287899|NCT01278303|P1|Participant Flow|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents~Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
287900|NCT01278303|O1|Outcome|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents~Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
287901|NCT01278303|O1|Outcome|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents~Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
287902|NCT01278303|O1|Outcome|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents~Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
287903|NCT01278303|E1|Reported Event|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents~Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
287904|NCT01278173|B1|Baseline|Sabril|Vigabatrin, 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.
287905|NCT01278173|P1|Participant Flow|Sabril|Vigabatrin, 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.
287906|NCT01278173|O1|Outcome|Sabril|Vigabatrin, 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.
287907|NCT01278173|O1|Outcome|Sabril|Vigabatrin, 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.
287908|NCT01278173|E1|Reported Event|Vigabatrin|
287909|NCT01278160|B3|Baseline|Total|Total of all reporting groups
287910|NCT01278160|B2|Baseline|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
287911|NCT01278160|B1|Baseline|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
287912|NCT01278160|P2|Participant Flow|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
287913|NCT01278160|P1|Participant Flow|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
287962|NCT01277822|B2|Baseline|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
289217|NCT01274897|B2|Baseline|Placebo|Subjects received the saline placebo.
287914|NCT01278160|O2|Outcome|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
287915|NCT01278160|O1|Outcome|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
287916|NCT01278160|O2|Outcome|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
287917|NCT01278160|O1|Outcome|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
287918|NCT01278160|O2|Outcome|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
287919|NCT01278160|O1|Outcome|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
287920|NCT01278160|O2|Outcome|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
287921|NCT01278160|O1|Outcome|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
287922|NCT01278160|O2|Outcome|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
287923|NCT01278160|O1|Outcome|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
287924|NCT01278160|E2|Reported Event|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
287925|NCT01278160|E1|Reported Event|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
287926|NCT01278030|B3|Baseline|Total|Total of all reporting groups
287927|NCT01278030|B2|Baseline|Control|Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.
287928|NCT01278030|B1|Baseline|3D Echo-guided LV Lead Placement|The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.
287929|NCT01278030|P2|Participant Flow|Control|Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.
287930|NCT01278030|P1|Participant Flow|3D Echo-guided LV Lead Placement|The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.
287931|NCT01278030|O2|Outcome|Control|Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.
287932|NCT01278030|O1|Outcome|3D Echo-guided LV Lead Placement|The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.
287933|NCT01278030|E2|Reported Event|Control|Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.
287934|NCT01278030|E1|Reported Event|3D Echo-guided LV Lead Placement|The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.
287935|NCT01277887|B3|Baseline|Total|Total of all reporting groups
287936|NCT01277887|B2|Baseline|Smoking Cessation Counseling|"The intervention consists of 8 sessions provided over 10 weeks. Counseling commences 4 weeks before quitting smoking. Participants will also receive the nicotine patch for 6 weeks starting on the day of quit date.~Smoking Cessation Counseling: The smoking cessation counseling intervention will incorporate standard psychoeducational and behavioral smoking counseling techniques adapted from the American Lung Association Freedom from Smoking program."
287937|NCT01277887|B1|Baseline|Cognitive-Behavioral Counseling|"The intervention consists of 8 sessions provided over 10 weeks. Counseling commences 4 weeks before quitting smoking. Participants will also receive the nicotine patch for 6 weeks starting on the day of quit date.~Cognitive-Behavioral Counseling: The cognitive-behavioral intervention integrates standard smoking counseling adapted from the American Lung Association Freedom from Smoking program along with cognitive-behavioral techniques for improving insomnia."
287938|NCT01277887|P2|Participant Flow|Smoking Cessation Counseling|"The intervention consists of 8 sessions provided over 10 weeks. Counseling commences 4 weeks before quitting smoking. Participants will also receive the nicotine patch for 6 weeks starting on the day of quit date.~Smoking Cessation Counseling: The smoking cessation counseling intervention will incorporate standard psychoeducational and behavioral smoking counseling techniques adapted from the American Lung Association Freedom from Smoking program."
287939|NCT01277887|P1|Participant Flow|Cognitive-Behavioral Counseling|"The intervention consists of 8 sessions provided over 10 weeks. Counseling commences 4 weeks before quitting smoking. Participants will also receive the nicotine patch for 6 weeks starting on the day of quit date.~Cognitive-Behavioral Counseling: The cognitive-behavioral intervention integrates standard smoking counseling adapted from the American Lung Association Freedom from Smoking program along with cognitive-behavioral techniques for improving insomnia."
287940|NCT01277887|O2|Outcome|Smoking Cessation Counseling|"The intervention consists of 8 sessions provided over 10 weeks. Counseling commences 4 weeks before quitting smoking. Participants will also receive the nicotine patch for 6 weeks starting on the day of quit date.~Smoking Cessation Counseling: The smoking cessation counseling intervention will incorporate standard psychoeducational and behavioral smoking counseling techniques adapted from the American Lung Association Freedom from Smoking program."
287941|NCT01277887|O1|Outcome|Cognitive-Behavioral Counseling|"The intervention consists of 8 sessions provided over 10 weeks. Counseling commences 4 weeks before quitting smoking. Participants will also receive the nicotine patch for 6 weeks starting on the day of quit date.~Cognitive-Behavioral Counseling: The cognitive-behavioral intervention integrates standard smoking counseling adapted from the American Lung Association Freedom from Smoking program along with cognitive-behavioral techniques for improving insomnia."
287942|NCT01277887|O2|Outcome|Smoking Cessation Counseling|"The intervention consists of 8 sessions provided over 10 weeks. Counseling commences 4 weeks before quitting smoking. Participants will also receive the nicotine patch for 6 weeks starting on the day of quit date.~Smoking Cessation Counseling: The smoking cessation counseling intervention will incorporate standard psychoeducational and behavioral smoking counseling techniques adapted from the American Lung Association Freedom from Smoking program."
287943|NCT01277887|O1|Outcome|Cognitive-Behavioral Counseling|"The intervention consists of 8 sessions provided over 10 weeks. Counseling commences 4 weeks before quitting smoking. Participants will also receive the nicotine patch for 6 weeks starting on the day of quit date.~Cognitive-Behavioral Counseling: The cognitive-behavioral intervention integrates standard smoking counseling adapted from the American Lung Association Freedom from Smoking program along with cognitive-behavioral techniques for improving insomnia."
287944|NCT01277887|O2|Outcome|Smoking Cessation Counseling|"The intervention consists of 8 sessions provided over 10 weeks. Counseling commences 4 weeks before quitting smoking. Participants will also receive the nicotine patch for 6 weeks starting on the day of quit date.~Smoking Cessation Counseling: The smoking cessation counseling intervention will incorporate standard psychoeducational and behavioral smoking counseling techniques adapted from the American Lung Association Freedom from Smoking program."
287945|NCT01277887|O1|Outcome|Cognitive-Behavioral Counseling|"The intervention consists of 8 sessions provided over 10 weeks. Counseling commences 4 weeks before quitting smoking. Participants will also receive the nicotine patch for 6 weeks starting on the day of quit date.~Cognitive-Behavioral Counseling: The cognitive-behavioral intervention integrates standard smoking counseling adapted from the American Lung Association Freedom from Smoking program along with cognitive-behavioral techniques for improving insomnia."
287946|NCT01277887|E2|Reported Event|Smoking Cessation Counseling|"The intervention consists of 8 sessions provided over 10 weeks. Counseling commences 4 weeks before quitting smoking. Participants will also receive the nicotine patch for 6 weeks starting on the day of quit date.~Smoking Cessation Counseling: The smoking cessation counseling intervention will incorporate standard psychoeducational and behavioral smoking counseling techniques adapted from the American Lung Association Freedom from Smoking program."
287947|NCT01277887|E1|Reported Event|Cognitive-Behavioral Counseling|"The intervention consists of 8 sessions provided over 10 weeks. Counseling commences 4 weeks before quitting smoking. Participants will also receive the nicotine patch for 6 weeks starting on the day of quit date.~Cognitive-Behavioral Counseling: The cognitive-behavioral intervention integrates standard smoking counseling adapted from the American Lung Association Freedom from Smoking program along with cognitive-behavioral techniques for improving insomnia."
287948|NCT01277861|B3|Baseline|Total|Total of all reporting groups
287949|NCT01277861|B2|Baseline|SALINE|SALINE
287950|NCT01277861|B1|Baseline|FENTANYL|FENTANYL
287951|NCT01277861|P2|Participant Flow|SALINE|SALINE
287952|NCT01277861|P1|Participant Flow|FENTANYL|FENTANYL
287953|NCT01277861|O2|Outcome|Saline Pretreatment Group|Saline 10 ml prior to induction of anesthesia.
287954|NCT01277861|O1|Outcome|Fentanyl Pretreatment Group|Fentanyl 1 µg/kg (constituted to 10 ml with saline) prior to induction of anesthesia.
287955|NCT01277861|O2|Outcome|Saline Pretreatment Group|
287956|NCT01277861|O1|Outcome|Fentanyl Pretreatment Group|
287957|NCT01277861|O2|Outcome|Saline Pretreatment Group|Saline 10 ml prior to induction of anesthesia.
287958|NCT01277861|O1|Outcome|Fentanyl Pretreatment Group|Fentanyl 1 µg/kg (constituted to 10 ml with saline) prior to induction of anesthesia.
287959|NCT01277861|E2|Reported Event|SALINE|SALINE
287960|NCT01277861|E1|Reported Event|FENTANYL|FENTANYL
287961|NCT01277822|B3|Baseline|Total|Total of all reporting groups
326797|NCT01181011|E2|Reported Event|Telmisartan 80mg|
287963|NCT01277822|B1|Baseline|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
287964|NCT01277822|P2|Participant Flow|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
287965|NCT01277822|P1|Participant Flow|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
287966|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
287967|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
287968|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
287969|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
287970|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
287971|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
287972|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
287973|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
287974|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
287975|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
287976|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
287977|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
287978|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
287979|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
287980|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
287981|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
287982|NCT01277822|E2|Reported Event|Amlodipine 10mg|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
287983|NCT01277822|E1|Reported Event|Losartan 100mg/Amlodipine 5mg|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks
287984|NCT01277757|B1|Baseline|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
287985|NCT01277757|P1|Participant Flow|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
287986|NCT01277757|O1|Outcome|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
287987|NCT01277757|O1|Outcome|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
287988|NCT01277757|O1|Outcome|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
287989|NCT01277757|O1|Outcome|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
287990|NCT01277757|E1|Reported Event|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
287991|NCT01277718|B1|Baseline|Entire Study Population|All participants randomized to any treatment.
288014|NCT01277666|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg once daily hard gelatin capsules orally for 12 weeks treatment period.
288015|NCT01277666|O1|Outcome|Placebo|Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period.
287992|NCT01277718|P2|Participant Flow|Treatment A First, Then Treatment C, Followed by Treatment B|Treatment A in Period 1: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast. Treatment C in Period 2: 20 mg oral rabeprazole administered once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state. Approximately 30 minutes later, participants were provided a standardized FDA high-fat meal, and approximately 30 minutes after starting the meal, one 20-mg tablet of cobimetinib was administered orally with 240 mL room temperature water. Treatment B in Period 3: 20 mg oral rabeprazole administered once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state followed by one 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast. There was minimum of a 13-day washout between cobimetinib doses of each period.
287993|NCT01277718|P1|Participant Flow|Treatment A First, Then Treatment B, Followed by Treatment C|Treatment A in Period 1: One 20-mg tablet of cobimetinib administered orally with 240 milliliters (mL) room temperature water after at least an 8-hour fast. Treatment B in Period 2: 20 mg oral rabeprazole administered once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state followed by one 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast. Treatment C in Period 3: 20 mg oral rabeprazole administered once daily for 4 days starting on Day -4. On Day 1, 20 mg rabeprazole was administered in fasted state. Approximately 30 minutes later, participants were provided a standardized Food and Drug Administration (FDA) high-fat meal, and approximately 30 minutes after starting the meal, one 20-mg tablet of cobimetinib was administered orally with 240 mL room temperature water. There was minimum of a 13-day washout between cobimetinib doses of each period.
287994|NCT01277718|O3|Outcome|Cobimetinib [Fed] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state. Approximately 30 minutes later, participants were provided a standardized FDA high-fat meal, and approximately 30 minutes after starting the meal, one 20-mg tablet of cobimetinib was administered orally with 240 mL room temperature water.
287995|NCT01277718|O2|Outcome|Cobimetinib [Fasted] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state followed by one 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
287996|NCT01277718|O1|Outcome|Cobimetinib [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
287997|NCT01277718|O3|Outcome|Cobimetinib [Fed] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state. Approximately 30 minutes later, participants were provided a standardized FDA high-fat meal, and approximately 30 minutes after starting the meal, one 20-mg tablet of cobimetinib was administered orally with 240 mL room temperature water.
287998|NCT01277718|O2|Outcome|Cobimetinib [Fasted] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state followed by one 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
287999|NCT01277718|O1|Outcome|Cobimetinib [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
288000|NCT01277718|E3|Reported Event|Cobimetinib [Fed] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state. Approximately 30 minutes later, participants were provided a standardized FDA high-fat meal, and approximately 30 minutes after starting the meal, one 20-mg tablet of cobimetinib was administered orally with 240 mL room temperature water.
288001|NCT01277718|E2|Reported Event|Cobimetinib [Fasted] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state followed by one 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
288002|NCT01277718|E1|Reported Event|Cobimetinib [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
288003|NCT01277666|B4|Baseline|Total|Total of all reporting groups
288004|NCT01277666|B3|Baseline|GSK1605786A 500 mg Twice Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period.
288005|NCT01277666|B2|Baseline|GSK1605786A 500 mg Once Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg once daily hard gelatin capsules orally for 12 weeks treatment period.
288006|NCT01277666|B1|Baseline|Placebo|Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period.
288007|NCT01277666|P3|Participant Flow|GSK1605786A 500 mg Twice Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period
288008|NCT01277666|P2|Participant Flow|GSK1605786A 500 mg Once Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 milligram (mg) once daily hard gelatin capsules orally for 12 weeks treatment period
288009|NCT01277666|P1|Participant Flow|Placebo|Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period
288010|NCT01277666|O3|Outcome|GSK1605786A 500 mg Twice Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period.
288011|NCT01277666|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg once daily hard gelatin capsules orally for 12 weeks treatment period.
288012|NCT01277666|O1|Outcome|Placebo|Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period.
288013|NCT01277666|O3|Outcome|GSK1605786A 500 mg Twice Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period.
326798|NCT01181011|E1|Reported Event|Telmisartan 80mg, Amlodipine 5mg|
288016|NCT01277666|O3|Outcome|GSK1605786A 500 mg Twice Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period.
288017|NCT01277666|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg once daily hard gelatin capsules orally for 12 weeks treatment period.
288018|NCT01277666|O1|Outcome|Placebo|Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period.
288019|NCT01277666|O3|Outcome|GSK1605786A 500 mg Twice Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period.
288020|NCT01277666|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg once daily hard gelatin capsules orally for 12 weeks treatment period.
288021|NCT01277666|O1|Outcome|Placebo|Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period.
288022|NCT01277666|O3|Outcome|GSK1605786A 500 mg Twice Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period.
288023|NCT01277666|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg once daily hard gelatin capsules orally for 12 weeks treatment period.
288024|NCT01277666|O1|Outcome|Placebo|Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period.
288025|NCT01277666|O3|Outcome|GSK1605786A 500 mg Twice Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period.
288026|NCT01277666|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg once daily hard gelatin capsules orally for 12 weeks treatment period.
288027|NCT01277666|O1|Outcome|Placebo|Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period.
288028|NCT01277666|O3|Outcome|GSK1605786A 500 mg Twice Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period.
288029|NCT01277666|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg once daily hard gelatin capsules orally for 12 weeks treatment period.
288030|NCT01277666|O1|Outcome|Placebo|Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period.
288031|NCT01277666|O3|Outcome|GSK1605786A 500 mg Twice Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period.
288032|NCT01277666|O2|Outcome|GSK1605786A 500 mg Once Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg once daily hard gelatin capsules orally for 12 weeks treatment period.
288033|NCT01277666|O1|Outcome|Placebo|Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period.
288034|NCT01277666|E3|Reported Event|GSK1605786A 500 mg Twice Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period.
288035|NCT01277666|E2|Reported Event|GSK1605786A 500 mg Once Daily|Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg once daily hard gelatin capsules orally for 12 weeks treatment period.
288036|NCT01277666|E1|Reported Event|Placebo|Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period.
288037|NCT01277601|B5|Baseline|Total|Total of all reporting groups
288038|NCT01277601|B4|Baseline|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
288039|NCT01277601|B3|Baseline|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks
288040|NCT01277601|B2|Baseline|TDF 48 Weeks + Peg-IFN 16 Week|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
288041|NCT01277601|B1|Baseline|TDF+Peg-IFN 48 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
288042|NCT01277601|P4|Participant Flow|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
288043|NCT01277601|P3|Participant Flow|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks
288044|NCT01277601|P2|Participant Flow|TDF 48 Weeks + Peg-IFN 16 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
288045|NCT01277601|P1|Participant Flow|TDF+Peg-IFN 48 Weeks|Tenofovir disoproxil fumarate (TDF) 300 mg tablet once daily plus peginterferon α-2a (Peg-IFN) 180 µg subcutaneous (s.c.) injection once weekly for 48 weeks
288046|NCT01277601|O3|Outcome|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
288047|NCT01277601|O2|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
288048|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
288049|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288050|NCT01277601|O6|Outcome|Peg-IFN 48 Week (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
288051|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
288052|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288086|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
288053|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
288054|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288055|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
288056|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288057|NCT01277601|O6|Outcome|Peg-IFN 48 Week (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
288058|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
288059|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288060|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
288061|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288062|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
288063|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288064|NCT01277601|O6|Outcome|Peg-IFN 48 Week (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
288065|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
288066|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288067|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
288068|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288069|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
288070|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288071|NCT01277601|O6|Outcome|Peg-IFN 48 Weeks (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
288072|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
288073|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288074|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
288075|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288076|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
288077|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288078|NCT01277601|O6|Outcome|Peg-IFN 48 Weeks (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
288079|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
288080|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288081|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
288082|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288083|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
288084|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288085|NCT01277601|O6|Outcome|Peg-IFN 48 Weeks (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
288087|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288088|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
288089|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288090|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
288091|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288092|NCT01277601|O6|Outcome|Peg-IFN 48 Weeks (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
288093|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
288094|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288095|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Week (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
288096|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288097|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Week (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
288098|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288099|NCT01277601|O6|Outcome|Peg-IFN 48 Weeks (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
288100|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
288101|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288102|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Week (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
288103|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288104|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Week (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
288105|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288106|NCT01277601|O6|Outcome|Peg-IFN 48 Weeks (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
288107|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
288108|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288109|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Week (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
288110|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
288111|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Week (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
288112|NCT01277601|O4|Outcome|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
288113|NCT01277601|O3|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks
288114|NCT01277601|O2|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
288115|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
288116|NCT01277601|O4|Outcome|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
288117|NCT01277601|O3|Outcome|TDF 120 Week|TDF 300 mg tablet once daily for 120 weeks
288118|NCT01277601|O2|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
288119|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
288120|NCT01277601|O3|Outcome|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
288121|NCT01277601|O2|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks
288122|NCT01277601|O1|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
326799|NCT01180998|B4|Baseline|Total|Total of all reporting groups
288126|NCT01277601|E7|Reported Event|Peg-IFN 48 Weeks (Retreated)|"Adverse events in this reporting group are those occurring during the retreatment phase (from start of retreatment up to Week 120 plus 30 days).~TDF 300 mg tablet once daily up to Week 120"
288127|NCT01277601|E6|Reported Event|Peg-IFN 48 Weeks (Not Retreated)|"Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days.~Peg-IFN 180 µg s.c. injection once weekly for 48 weeks"
288128|NCT01277601|E5|Reported Event|TDF 120 Weeks|"Adverse events in this reporting group are those occurring during the initial treatment phase (up to 120 weeks plus 30 days).~TDF 300 mg tablet once daily for up to 120 weeks"
288129|NCT01277601|E4|Reported Event|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|"Adverse events in this reporting group are those occurring after TDF retreatment through last TDF retreatment dose plus 30 days.~TDF 300 mg tablet once daily up to Week 120"
288130|NCT01277601|E3|Reported Event|TDF 48 Week + Peg-IFN 16 Weeks (Not Retreated)|"Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days.~TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks"
288131|NCT01277601|E2|Reported Event|TDF+Peg-IFN 48 Weeks (Retreated)|"Adverse events in this reporting group are those occurring after TDF retreatment through last TDF retreatment dose plus 30 days.~TDF 300 mg tablet once daily up to Week 120"
288132|NCT01277601|E1|Reported Event|TDF+Peg-IFN 48 Weeks (Not Retreated)|"Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days.~TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks"
288133|NCT01277549|B3|Baseline|Total|Total of all reporting groups
288134|NCT01277549|B2|Baseline|Nonmobilized Donors|Donors not mobilized prior to MNC collection
288135|NCT01277549|B1|Baseline|G-CSF Mobilized Donors|Donors received G-CSF prior to MNC collection
288136|NCT01277549|P2|Participant Flow|Non-mobilized Donors|In this arm, donors were not mobilized prior to mononuclear cell collection. Only collection efficiency of mononuclear cells could be assessed as CD34+ cells are not present in this population.
288137|NCT01277549|P1|Participant Flow|G-CSF Mobilized Donors|In this arm the donors received G-CSF (granulocyte colony stimulating factor) prior to the MNC (mononuclear cell) collection. G-CSF causes the mobilization of hematopoetic stem cells which are CD34 (cluster of differentiation 34) + to the peripheral blood. Collection efficiency of all mononuclear cells and of the CD34+ subset of mononuclear cells was assessed.
288138|NCT01277549|O1|Outcome|G-CSF Mobilized Donors|Donors received G-CSF prior to MNC collection.
288139|NCT01277549|O1|Outcome|G-CSF Mobilized Donors|Donors received G-CSF prior to MNC collection
288140|NCT01277549|O2|Outcome|Nonmobilized Donors|In this arm, donors were not mobilized prior to collection.
288141|NCT01277549|O1|Outcome|G-CSF Mobilized Donors|In this arm, donors were mobilized with G-CSF prior to collection.
288142|NCT01277549|O2|Outcome|Nonmobilized Donors|In this arm, donors were not mobilized prior to collection.
288143|NCT01277549|O1|Outcome|G-CSF Mobilized Donors|In this arm, donors were mobilized with G-CSF prior to collection.
288144|NCT01277549|O2|Outcome|Nonmobilized Donors|In this arm, donors were not mobilized prior to collection.
288145|NCT01277549|O1|Outcome|G-CSF Mobilized Donors|In this arm, donors were mobilized with G-CSF prior to collection.
288146|NCT01277549|O2|Outcome|Nonmobilized Donors|Donors were not mobilized prior to MNC collection.
288147|NCT01277549|O1|Outcome|G-CSF Mobilized Donors|Donors received G-CSF prior to MNC collection.
288148|NCT01277549|E2|Reported Event|Nonmobilized Donors|"Donors not mobilized prior to MNC collection. Note that some Adverse Events (Flu-like symptoms, Muscle Aches, and Bone Pain) apply only to G-CSF mobilized donors. Nonmobilized donors were not assessed for these adverse events as they were not at risk."
288149|NCT01277549|E1|Reported Event|G-CSF Mobilized Donors|Donors received G-CSF prior to MNC collection
288150|NCT01277523|B4|Baseline|Total|Total of all reporting groups
288151|NCT01277523|B3|Baseline|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288152|NCT01277523|B2|Baseline|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288153|NCT01277523|B1|Baseline|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288154|NCT01277523|P3|Participant Flow|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288155|NCT01277523|P2|Participant Flow|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288156|NCT01277523|P1|Participant Flow|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288157|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288158|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288159|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288160|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288161|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288162|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288163|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288165|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288166|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288167|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288168|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288169|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288170|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288171|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288172|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288173|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288174|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288175|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288176|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288177|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288178|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288179|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288180|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288181|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288182|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288183|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288184|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288185|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288186|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288187|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288188|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288189|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288190|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288191|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288192|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288193|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288194|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288195|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288196|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288197|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288198|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288199|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288200|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288201|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
289218|NCT01274897|B1|Baseline|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
288202|NCT01277523|E3|Reported Event|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288203|NCT01277523|E2|Reported Event|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288204|NCT01277523|E1|Reported Event|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
288205|NCT01277510|B3|Baseline|Total|Total of all reporting groups
288206|NCT01277510|B2|Baseline|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
288207|NCT01277510|B1|Baseline|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
288208|NCT01277510|P2|Participant Flow|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
288209|NCT01277510|P1|Participant Flow|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
288210|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
288211|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
288212|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
288213|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
288214|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
288215|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
288216|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
288217|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
288295|NCT01277159|P3|Participant Flow|Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp|"Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)~C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg): C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)"
288218|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
288219|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
288220|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
288221|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
288222|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
288223|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
288224|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
288225|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
288226|NCT01277510|E4|Reported Event|Open-label Phase: Previous Cinacalcet|
288227|NCT01277510|E3|Reported Event|Open-label Phase: Previous Placebo|
288228|NCT01277510|E2|Reported Event|Double-blind Phase: Cinacalcet|
288229|NCT01277510|E1|Reported Event|Double-blind Phase: Placebo|
288230|NCT01277354|B3|Baseline|Total|Total of all reporting groups
288231|NCT01277354|B2|Baseline|Waitlist Group|Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
288232|NCT01277354|B1|Baseline|CPT Group|Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
288233|NCT01277354|P2|Participant Flow|Waitlist Group|Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
288234|NCT01277354|P1|Participant Flow|CPT Group|Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
288235|NCT01277354|O2|Outcome|Waitlist Group|Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
288236|NCT01277354|O1|Outcome|CPT Group|Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
288237|NCT01277354|E2|Reported Event|Waitlist Group|Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
288238|NCT01277354|E1|Reported Event|CPT Group|Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
288239|NCT01277302|B4|Baseline|Total|Total of all reporting groups
288240|NCT01277302|B3|Baseline|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
288241|NCT01277302|B2|Baseline|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
288293|NCT01277159|P5|Participant Flow|Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine|"Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.~E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).~IV saline."
288836|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
288242|NCT01277302|B1|Baseline|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
288243|NCT01277302|P3|Participant Flow|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
288244|NCT01277302|P2|Participant Flow|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
288245|NCT01277302|P1|Participant Flow|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
288246|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
288247|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
288248|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
288249|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
288250|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
288251|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
288252|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
288253|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
288254|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
288255|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
288256|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
288294|NCT01277159|P4|Participant Flow|Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone (|"Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).~D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg)."
289219|NCT01274897|P2|Participant Flow|Placebo|Subjects received the saline placebo.
288257|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
288258|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
288259|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
288260|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
288261|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
288262|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
288263|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
288264|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
288265|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
288266|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
288267|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
288268|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
288269|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
288270|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
288271|NCT01277302|E3|Reported Event|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
288296|NCT01277159|P2|Participant Flow|Nerve Block With Dexamethasone (4 mg). IV Saline.|"B. Nerve Block with Dexamethasone (4 mg). IV saline.~B. Nerve Block with Dexamethasone (4 mg). IV saline.: B. Nerve Block with Dexamethasone (4 mg). IV saline."
288272|NCT01277302|E2|Reported Event|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
288273|NCT01277302|E1|Reported Event|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
288274|NCT01277211|B3|Baseline|Total|Total of all reporting groups
288275|NCT01277211|B2|Baseline|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
288276|NCT01277211|B1|Baseline|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
288277|NCT01277211|P2|Participant Flow|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
288278|NCT01277211|P1|Participant Flow|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
288279|NCT01277211|O2|Outcome|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
288280|NCT01277211|O1|Outcome|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
288281|NCT01277211|O2|Outcome|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
288282|NCT01277211|O1|Outcome|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
288283|NCT01277211|O2|Outcome|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
288284|NCT01277211|O1|Outcome|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
288285|NCT01277211|E2|Reported Event|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
288286|NCT01277211|E1|Reported Event|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
288287|NCT01277159|B6|Baseline|Total|Total of all reporting groups
288288|NCT01277159|B5|Baseline|Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine|"Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.~E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).~IV saline."
288289|NCT01277159|B4|Baseline|Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone (|"Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).~D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg)."
288290|NCT01277159|B3|Baseline|Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp|"Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)~C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg): C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)"
288291|NCT01277159|B2|Baseline|Nerve Block With Dexamethasone (4 mg). IV Saline.|"B. Nerve Block with Dexamethasone (4 mg). IV saline.~B. Nerve Block with Dexamethasone (4 mg). IV saline.: B. Nerve Block with Dexamethasone (4 mg). IV saline."
288292|NCT01277159|B1|Baseline|Control Nerve Block. IV Dexamethasone (4 mg).|"Control Nerve Block. IV Dexamethasone (4 mg).~A. Control Nerve Block. IV Dexamethasone (4 mg).: A. Control Nerve Block. IV Dexamethasone (4 mg)."
288297|NCT01277159|P1|Participant Flow|Control Nerve Block. IV Dexamethasone (4 mg).|"Control Nerve Block. IV Dexamethasone (4 mg).~A. Control Nerve Block. IV Dexamethasone (4 mg).: A. Control Nerve Block. IV Dexamethasone (4 mg)."
288298|NCT01277159|O5|Outcome|Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine|"Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.~E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).~IV saline."
288299|NCT01277159|O4|Outcome|Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone (|"Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).~D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg)."
288300|NCT01277159|O3|Outcome|Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp|"Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)~C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg): C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)"
288301|NCT01277159|O2|Outcome|Nerve Block With Dexamethasone (4 mg). IV Saline.|"B. Nerve Block with Dexamethasone (4 mg). IV saline.~B. Nerve Block with Dexamethasone (4 mg). IV saline.: B. Nerve Block with Dexamethasone (4 mg). IV saline."
288302|NCT01277159|O1|Outcome|Control Nerve Block. IV Dexamethasone (4 mg).|"Control Nerve Block. IV Dexamethasone (4 mg).~A. Control Nerve Block. IV Dexamethasone (4 mg).: A. Control Nerve Block. IV Dexamethasone (4 mg)."
288303|NCT01277159|E5|Reported Event|Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine|"Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.~E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).~IV saline."
288304|NCT01277159|E4|Reported Event|Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone (|"Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).~D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg)."
288305|NCT01277159|E3|Reported Event|Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp|"Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)~C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg): C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)"
288306|NCT01277159|E2|Reported Event|Nerve Block With Dexamethasone (4 mg). IV Saline.|"B. Nerve Block with Dexamethasone (4 mg). IV saline.~B. Nerve Block with Dexamethasone (4 mg). IV saline.: B. Nerve Block with Dexamethasone (4 mg). IV saline."
288307|NCT01277159|E1|Reported Event|Control Nerve Block. IV Dexamethasone (4 mg).|"Control Nerve Block. IV Dexamethasone (4 mg).~A. Control Nerve Block. IV Dexamethasone (4 mg).: A. Control Nerve Block. IV Dexamethasone (4 mg)."
288308|NCT01277081|B3|Baseline|Total|Total of all reporting groups
288309|NCT01277081|B2|Baseline|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
288310|NCT01277081|B1|Baseline|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
288311|NCT01277081|P2|Participant Flow|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
288312|NCT01277081|P1|Participant Flow|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 milligram (mg) of paracetamol in 200 milliliter (mL) of boiled mineral water was taken orally by participants within a time period of 15 minutes.
288313|NCT01277081|O2|Outcome|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
288314|NCT01277081|O1|Outcome|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
288315|NCT01277081|O2|Outcome|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
288316|NCT01277081|O1|Outcome|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
288317|NCT01277081|O2|Outcome|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
288318|NCT01277081|O1|Outcome|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
288319|NCT01277081|O2|Outcome|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
288320|NCT01277081|O1|Outcome|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
288321|NCT01277081|O2|Outcome|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
288322|NCT01277081|O1|Outcome|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
288323|NCT01277081|O2|Outcome|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
288324|NCT01277081|O1|Outcome|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
288325|NCT01277081|E2|Reported Event|Paracetamol Tablets|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
288326|NCT01277081|E1|Reported Event|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
288327|NCT01277042|B3|Baseline|Total|Total of all reporting groups
288328|NCT01277042|B2|Baseline|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
288329|NCT01277042|B1|Baseline|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
288837|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
288330|NCT01277042|P2|Participant Flow|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
288331|NCT01277042|P1|Participant Flow|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
288332|NCT01277042|O2|Outcome|Engerix-B Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
288333|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
288334|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
288335|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
288336|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
288337|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
288338|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
288339|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
288340|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
288341|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
288342|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
288343|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
288344|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
288345|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
288346|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
288347|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
288348|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
288349|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
288350|NCT01277042|E2|Reported Event|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
288351|NCT01277042|E1|Reported Event|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
288352|NCT01276847|B4|Baseline|Total|Total of all reporting groups
288353|NCT01276847|B3|Baseline|Ustekinumab|Ustekinumab : Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16
288354|NCT01276847|B2|Baseline|No Treatment|No treatment administered
288355|NCT01276847|B1|Baseline|Etanercept|Etanercept : Etanercept 50 mg twice weekly by self-administered subcutaneous injection for 12 weeks, then once weekly for 4 weeks
288356|NCT01276847|P3|Participant Flow|Ustekinumab|Ustekinumab : Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16
288357|NCT01276847|P2|Participant Flow|No Treatment|No treatment administered
288358|NCT01276847|P1|Participant Flow|Etanercept|Etanercept : Etanercept 50 mg twice weekly by self-administered subcutaneous injection for 12 weeks, then once weekly for 4 weeks
288359|NCT01276847|O1|Outcome|Etanercept|Etanercept : Etanercept 50 mg twice weekly by self-administered subcutaneous injection for 12 weeks, then once weekly for 4 weeks
288360|NCT01276847|O1|Outcome|Ustekinumab|Ustekinumab : Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16
288361|NCT01276847|O1|Outcome|Ustekinumab|Ustekinumab : Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16
288362|NCT01276847|E3|Reported Event|Ustekinumab|Ustekinumab : Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16
288363|NCT01276847|E2|Reported Event|No Treatment|No treatment administered
288364|NCT01276847|E1|Reported Event|Etanercept|Etanercept : Etanercept 50 mg twice weekly by self-administered subcutaneous injection for 12 weeks, then once weekly for 4 weeks
288365|NCT01276821|B3|Baseline|Total|Total of all reporting groups
288366|NCT01276821|B2|Baseline|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
288367|NCT01276821|B1|Baseline|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
288368|NCT01276821|P2|Participant Flow|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
288369|NCT01276821|P1|Participant Flow|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
288370|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
288371|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
288372|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
288373|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
288374|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
288375|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
288376|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
288377|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
288378|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
288379|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
288380|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
288381|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
288382|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
288383|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
288384|NCT01276821|E2|Reported Event|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
288385|NCT01276821|E1|Reported Event|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
288386|NCT01276756|B3|Baseline|Total|Total of all reporting groups
288387|NCT01276756|B2|Baseline|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
288388|NCT01276756|B1|Baseline|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
288389|NCT01276756|P2|Participant Flow|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
288390|NCT01276756|P1|Participant Flow|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
288391|NCT01276756|O2|Outcome|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
288392|NCT01276756|O1|Outcome|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
288393|NCT01276756|O2|Outcome|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
288394|NCT01276756|O1|Outcome|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
288395|NCT01276756|O2|Outcome|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
288396|NCT01276756|O1|Outcome|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
288470|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288397|NCT01276756|O2|Outcome|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
288398|NCT01276756|O1|Outcome|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
288399|NCT01276756|O2|Outcome|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
288400|NCT01276756|O1|Outcome|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
288401|NCT01276756|E2|Reported Event|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
288402|NCT01276756|E1|Reported Event|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
288403|NCT01276652|B4|Baseline|Total|Total of all reporting groups
288404|NCT01276652|B3|Baseline|Usual Care (Observational)|Usual care was provided for the first 48 hours.
288405|NCT01276652|B2|Baseline|Usual Care (Randomized)|Usual Care was provided for the first 48 hours.
288406|NCT01276652|B1|Baseline|Environmental Modification|Subjects received an environmental modification intervention designed to strengthen day/night routines for the first 48 hours beginning the morning after enrollment. Usual Care was provided outside of this interval. Environmental modification consisted of nursing-related efforts to optimize daytime light exposure, to minimize nighttime light and noise exposure, and to batch nursing care at night.
288407|NCT01276652|P3|Participant Flow|Usual Care (Observational)|Subjects received usual care for 48 hours beginning the morning after enrollment.
288408|NCT01276652|P2|Participant Flow|Randomization: Usual Care|Subjects received usual care for 48 hours beginning the morning after enrollment. A subset of this group received the intervention on a pilot basis after this time period had elapsed.
288409|NCT01276652|P1|Participant Flow|Randomization: Environmental Modification Group|Subjects randomized to this group underwent the environmental modification intervention designed to promote strong day/night routines for 48 hours.
288410|NCT01276652|O3|Outcome|Usual Care (Observational)|Usual care was provided to the subjects.
288411|NCT01276652|O2|Outcome|Usual Care (Randomized)|Usual Care was provided to the subjects.
288412|NCT01276652|O1|Outcome|Environmental Modification|A subset of subjects were randomly assigned to receive an environmental modification intervention either early (first 48 hrs) or late (next 48 hrs). Usual Care was provided outside of this interval. Environmental modification consisted of nursing-related efforts to optimize daytime light exposure, to minimize nighttime light and noise exposure, and to batch nursing care at night.
288413|NCT01276652|O3|Outcome|Usual Care (Observational)|Usual care was provided to the subjects.
288414|NCT01276652|O2|Outcome|Usual Care (Randomized)|Usual Care was provided to the subjects.
288415|NCT01276652|O1|Outcome|Environmental Modification|A subset of subjects were randomly assigned to receive an environmental modification intervention either early (first 48 hrs) or late (next 48 hrs). Usual Care was provided outside of this interval. Environmental modification consisted of nursing-related efforts to optimize daytime light exposure, to minimize nighttime light and noise exposure, and to batch nursing care at night.
288416|NCT01276652|O3|Outcome|Usual Care (Observational)|Usual care was provided to the subjects.
288417|NCT01276652|O2|Outcome|Usual Care (Randomized)|Usual Care was provided to the subjects.
288418|NCT01276652|O1|Outcome|Environmental Modification|A subset of subjects were randomly assigned to receive an environmental modification intervention either early (first 48 hrs) or late (next 48 hrs). Usual Care was provided outside of this interval. Environmental modification consisted of nursing-related efforts to optimize daytime light exposure, to minimize nighttime light and noise exposure, and to batch nursing care at night.
288419|NCT01276652|O3|Outcome|Usual Care (Observational)|Usual care was provided to the subjects.
288420|NCT01276652|O2|Outcome|Usual Care (Randomized)|Usual Care was provided to the subjects.
288421|NCT01276652|O1|Outcome|Environmental Modification|A subset of subjects were randomly assigned to receive an environmental modification intervention either early (first 48 hrs) or late (next 48 hrs). Usual Care was provided outside of this interval. Environmental modification consisted of nursing-related efforts to optimize daytime light exposure, to minimize nighttime light and noise exposure, and to batch nursing care at night.
288422|NCT01276652|O3|Outcome|Usual Care (Observational)|Usual care is provided to the subjects for 48 hours.
288423|NCT01276652|O2|Outcome|Usual Care (Randomized)|Usual care for 48 hours.
288424|NCT01276652|O1|Outcome|Environmental Modification|"In a subset of this study, subjects are randomly assigned to receive an environmental modification intervention either early (first 48 hrs) or late (next 48 hrs). Usual Care was provided outside of this interval.~Environmental modification: Environmental modification consists of nursing-related efforts to optimize daytime light exposure, to minimize nighttime light and noise exposure, and to batch nursing care at night."
288425|NCT01276652|O3|Outcome|Usual Care (Observational)|Usual care was provided for 48 hours.
288426|NCT01276652|O2|Outcome|Usual Care (Randomized)|Usual Care was provided during the first 48 hours.
288557|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288427|NCT01276652|O1|Outcome|Environmental Modification|A subset of subjects were randomly assigned to receive an environmental modification intervention either early (first 48 hrs) or late (next 48 hrs). Usual Care was provided outside of this interval. Environmental modification consisted of nursing-related efforts to optimize daytime light exposure, to minimize nighttime light and noise exposure, and to batch nursing care at night.
288428|NCT01276652|E3|Reported Event|Usual Care (Observational)|Usual care is provided to the subjects.
288429|NCT01276652|E2|Reported Event|Usual Care (Randomized)|Usual care is provided to the subjects.
288430|NCT01276652|E1|Reported Event|Environmental Modification|Environmental modification is provided for the initial 48 hours and consists of nursing-related efforts to optimize daytime light exposure, to minimize nighttime light and noise exposure, and to batch nursing care at night.
288431|NCT01276639|B4|Baseline|Total|Total of all reporting groups
288432|NCT01276639|B3|Baseline|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
288433|NCT01276639|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288434|NCT01276639|B1|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288435|NCT01276639|P5|Participant Flow|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288436|NCT01276639|P4|Participant Flow|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288437|NCT01276639|P3|Participant Flow|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
288438|NCT01276639|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288439|NCT01276639|P1|Participant Flow|CP-690,550 5 mg|CP-690,550 (tofacitinib) 5 milligram (mg) tablet orally twice daily up to Week 52.
288440|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288441|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288442|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288443|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288444|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
288445|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288446|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288447|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
288448|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288449|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288450|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
288451|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288452|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288453|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
288454|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288455|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288456|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
288457|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288458|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288459|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
288460|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288461|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288462|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288463|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288464|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288465|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288466|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288467|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288468|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288469|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
326931|NCT01180777|O3|Outcome|Etafilcon A (C)|Daily wear contact lens
288471|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288472|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288473|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288474|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288475|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288476|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288477|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288478|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288479|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288480|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288481|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288482|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288483|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288484|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288485|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288486|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288487|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288488|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288489|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288490|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288491|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288492|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288493|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288494|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288495|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288496|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288497|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288498|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288499|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288500|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288501|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288502|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288503|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288504|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288505|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288506|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288507|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288508|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288509|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288510|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288511|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288512|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288513|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288603|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288514|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288515|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288516|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288517|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288518|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288519|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288520|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288521|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288522|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288523|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288524|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288525|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288526|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288527|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288528|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288529|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288530|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288531|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288532|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288533|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288534|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288535|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288536|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288537|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288538|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288539|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288540|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288541|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288542|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288543|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288544|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288545|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288546|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288547|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288548|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288549|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288550|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288551|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288552|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288553|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288554|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288555|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288556|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
326932|NCT01180777|O2|Outcome|Etafilcon A (B)|Daily wear contact lens
288558|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288559|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288560|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288561|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288562|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288563|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288564|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288565|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288566|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288567|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288568|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288569|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288570|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288571|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288572|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288573|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288574|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288575|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288576|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288577|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288578|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288579|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288580|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288581|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288582|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288583|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288584|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288585|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288586|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
288587|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288588|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288589|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
288590|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288591|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288592|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
288593|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288594|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288595|NCT01276639|O2|Outcome|CP-690,550 10 mg|Participants who received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288596|NCT01276639|O1|Outcome|CP-690,550 5 mg|Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288597|NCT01276639|O2|Outcome|CP-690,550 10 mg|Participants who received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288598|NCT01276639|O1|Outcome|CP-690,550 5 mg|Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288599|NCT01276639|O2|Outcome|CP-690,550 10 mg|Participants who received CP-690,550 10 mg tablet orally twice daily up to Week 52.
288600|NCT01276639|O1|Outcome|CP-690,550 5 mg|Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52.
288601|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
288602|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288604|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
288605|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288606|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288607|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
288608|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288609|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288610|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
288611|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288612|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288613|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
288614|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288615|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288616|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
288617|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288618|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288619|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
288620|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288621|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288622|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
288623|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288624|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288625|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
288626|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288627|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288628|NCT01276639|E5|Reported Event|Placebo|Participants who received placebo matched to CP-690,550 tablet orally twice daily up to Week 16 but were not re-randomized to CP-690,550 treatment.
288629|NCT01276639|E4|Reported Event|Placebo, CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16 and thereafter CP-690,550 10 mg tablet orally twice daily up to Week 52.
288630|NCT01276639|E3|Reported Event|Placebo, CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16 and thereafter CP-690,550 5 mg tablet orally twice daily up to Week 52.
288631|NCT01276639|E2|Reported Event|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
288632|NCT01276639|E1|Reported Event|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
288633|NCT01276535|B1|Baseline|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.~The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
288634|NCT01276535|P1|Participant Flow|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.~The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
288635|NCT01276535|O1|Outcome|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.~The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
288636|NCT01276535|O1|Outcome|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.~The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
288637|NCT01276535|O1|Outcome|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.~The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
288693|NCT01276509|E4|Reported Event|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
288694|NCT01276509|E3|Reported Event|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
288638|NCT01276535|E1|Reported Event|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.~The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
288639|NCT01276509|B5|Baseline|Total|Total of all reporting groups
288640|NCT01276509|B4|Baseline|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
288641|NCT01276509|B3|Baseline|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
288642|NCT01276509|B2|Baseline|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
288643|NCT01276509|B1|Baseline|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
288644|NCT01276509|P4|Participant Flow|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
288645|NCT01276509|P3|Participant Flow|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
288646|NCT01276509|P2|Participant Flow|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
288647|NCT01276509|P1|Participant Flow|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
288648|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
288649|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
288650|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
288651|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
288652|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
288653|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
288654|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
288655|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
288656|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
288657|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
288658|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
288659|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
288660|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
288661|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
288662|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
288663|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
288664|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
288665|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
288666|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
288667|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
288668|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
288669|NCT01276509|O4|Outcome|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
288670|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
288671|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
288672|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
288673|NCT01276509|O4|Outcome|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
288674|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
288675|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
288676|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
288677|NCT01276509|O4|Outcome|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
288678|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
288679|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
288680|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
288681|NCT01276509|O4|Outcome|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
288682|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
288683|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
288684|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
288685|NCT01276509|O4|Outcome|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
288686|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
288687|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
288688|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
288689|NCT01276509|O4|Outcome|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
288690|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
288691|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
288692|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
288698|NCT01276457|B2|Baseline|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
288699|NCT01276457|B1|Baseline|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
288700|NCT01276457|P2|Participant Flow|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
288701|NCT01276457|P1|Participant Flow|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
288702|NCT01276457|O2|Outcome|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
288703|NCT01276457|O1|Outcome|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
288704|NCT01276457|O2|Outcome|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
288705|NCT01276457|O1|Outcome|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
288706|NCT01276457|O2|Outcome|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
288707|NCT01276457|O1|Outcome|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
288708|NCT01276457|O2|Outcome|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
288709|NCT01276457|O1|Outcome|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
288741|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
288838|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
288710|NCT01276457|E2|Reported Event|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
288711|NCT01276457|E1|Reported Event|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
288712|NCT01276353|B3|Baseline|Total|Total of all reporting groups
288713|NCT01276353|B2|Baseline|E2020 10 mg|E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
288714|NCT01276353|B1|Baseline|E2020 SR 23 mg|E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
288715|NCT01276353|P2|Participant Flow|E2020 10 mg|E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
288716|NCT01276353|P1|Participant Flow|E2020 SR 23 mg|E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
288717|NCT01276353|O2|Outcome|E2020 10 mg|E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
288718|NCT01276353|O1|Outcome|E2020 SR 23 mg|E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once in the morning daily for 52 weeks in the extension phase.
288719|NCT01276353|O2|Outcome|E2020 10 mg (EM)|E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
288720|NCT01276353|O1|Outcome|E2020 SR 23 mg|E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
288721|NCT01276353|E4|Reported Event|E2020 10 mg (Extension)|E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
288722|NCT01276353|E3|Reported Event|E2020 SR 23 mg (Extension)|E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
288723|NCT01276353|E2|Reported Event|E2020 10 mg (Double-blind)|E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase.
288724|NCT01276353|E1|Reported Event|E2020 SR 23 mg (Double-blind)|E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase.
288725|NCT01276327|B3|Baseline|Total|Total of all reporting groups
288726|NCT01276327|B2|Baseline|Sequence RTRT|Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of RTRT.
288727|NCT01276327|B1|Baseline|Sequence TRTR|Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of TRTR.
288728|NCT01276327|P2|Participant Flow|Sequence RTRT|Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of RTRT.
288729|NCT01276327|P1|Participant Flow|Sequence TRTR|Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of TRTR.
288730|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
288731|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
288732|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
288733|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
288734|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
288735|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
288736|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
288737|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
288738|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
288739|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
288740|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
288743|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
288744|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
288745|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
288746|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
288747|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
288748|NCT01276327|E2|Reported Event|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
288749|NCT01276327|E1|Reported Event|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
288750|NCT01276314|B5|Baseline|Total|Total of all reporting groups
288751|NCT01276314|B4|Baseline|Control Group (DRESS)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Drug administration:~The control group of drug delivery: systemic intravenous steroid therapy, the dose is equivalent to prednisolone 1-1.5 mg / kg / day, according to the treatment of 3-4 days gradually decreased dose."
288752|NCT01276314|B3|Baseline|Anti- TNF-a Treatment (DRESS)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Etanercept administration:~The experimental group received the first dose of Etanercept (25 mg) i.v., followed by two doses per week and maintain 2 to 3 weeks~anti-TNF a: 25mg BIW, SC"
288753|NCT01276314|B2|Baseline|Control Group (SJS/TEN)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Drug administration:~The control group of drug delivery: systemic intravenous steroid therapy, the dose is equivalent to prednisolone 1-1.5 mg / kg / day, according to the treatment of 3-4 days gradually decreased dose."
288754|NCT01276314|B1|Baseline|Anti- TNF-a Treatment (SJS/TEN)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Etanercept administration:~The experimental group received the first dose of Etanercept (25 mg) i.v., followed by two doses per week and maintain 2 to 3 weeks~anti-TNF a: 25mg BIW, SC"
288755|NCT01276314|P4|Participant Flow|Control Group (DRESS)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Drug administration:~The control group of drug delivery: systemic intravenous steroid therapy, the dose is equivalent to prednisolone 1-1.5 mg / kg / day, according to the treatment of 3-4 days gradually decreased dose."
288756|NCT01276314|P3|Participant Flow|Anti- TNF-a Treatment (DRESS)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Etanercept administration:~The experimental group received the first dose of Etanercept (25 mg) i.v., followed by two doses per week and maintain 2 to 3 weeks~anti-TNF a: 25mg BIW, SC"
288757|NCT01276314|P2|Participant Flow|Control Group (SJS/TEN)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Drug administration:~The control group of drug delivery: systemic intravenous steroid therapy, the dose is equivalent to prednisolone 1-1.5 mg / kg / day, according to the treatment of 3-4 days gradually decreased dose."
288758|NCT01276314|P1|Participant Flow|Anti- TNF-a Treatment (SJS/TEN)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Etanercept administration:~The experimental group received the first dose of Etanercept (25 mg) i.v., followed by two doses per week and maintain 2 to 3 weeks~anti-TNF a: 25mg BIW, SC"
288759|NCT01276314|O4|Outcome|Control Group (DRESS)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Drug administration:~The control group of drug delivery: systemic intravenous steroid therapy, the dose is equivalent to prednisolone 1-1.5 mg / kg / day, according to the treatment of 3-4 days gradually decreased dose."
288760|NCT01276314|O3|Outcome|Anti- TNF-a Treatment (DRESS)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Etanercept administration:~The experimental group received the first dose of Etanercept (25 mg) i.v., followed by two doses per week and maintain 2 to 3 weeks~anti-TNF a: 25mg BIW, SC"
288761|NCT01276314|O2|Outcome|Control Group (SJS/TEN)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Drug administration:~The control group of drug delivery: systemic intravenous steroid therapy, the dose is equivalent to prednisolone 1-1.5 mg / kg / day, according to the treatment of 3-4 days gradually decreased dose."
288839|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
288840|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
288762|NCT01276314|O1|Outcome|Anti- TNF-a Treatment (SJS/TEN)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Etanercept administration:~The experimental group received the first dose of Etanercept (25 mg) i.v., followed by two doses per week and maintain 2 to 3 weeks~anti-TNF a: 25mg BIW, SC"
288763|NCT01276314|E4|Reported Event|Control Group (DRESS)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Drug administration:~The control group of drug delivery: systemic intravenous steroid therapy, the dose is equivalent to prednisolone 1-1.5 mg / kg / day, according to the treatment of 3-4 days gradually decreased dose."
288764|NCT01276314|E3|Reported Event|Anti- TNF-a Treatment (DRESS)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Etanercept administration:~The experimental group received the first dose of Etanercept (25 mg) i.v., followed by two doses per week and maintain 2 to 3 weeks~anti-TNF a: 25mg BIW, SC"
288765|NCT01276314|E2|Reported Event|Control Group (SJS/TEN)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Drug administration:~The control group of drug delivery: systemic intravenous steroid therapy, the dose is equivalent to prednisolone 1-1.5 mg / kg / day, according to the treatment of 3-4 days gradually decreased dose."
288766|NCT01276314|E1|Reported Event|Anti- TNF-a Treatment (SJS/TEN)|"Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF~Fill out the case report form~Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis~Etanercept administration:~The experimental group received the first dose of Etanercept (25 mg) i.v., followed by two doses per week and maintain 2 to 3 weeks~anti-TNF a: 25mg BIW, SC"
288767|NCT01276301|B1|Baseline|Entire Study Population|"An open label, randomised, two-period crossover trial. The two treatments administered were~A single dose of empagliflozin (empa) 25 mg~A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil~The two treatment periods were separated by a washout period of at least 7 days."
288768|NCT01276301|P2|Participant Flow|Empa Plus Verapamil / Empa|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil, followed by a washout period of at least 7 days, followed by a single dose of empagliflozin (empa) 25 mg.
288769|NCT01276301|P1|Participant Flow|Empa / Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg, followed by a washout period of at least 7 days, followed by a single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
288770|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
288771|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
288772|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
288773|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
288774|NCT01276301|O1|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
288775|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
288776|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
288777|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
288778|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
288779|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
288780|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
288781|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
288782|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
288783|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
288784|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
288785|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
288786|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
288787|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
288788|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
288789|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
288790|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
288791|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
288792|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
288793|NCT01276301|E2|Reported Event|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
288794|NCT01276301|E1|Reported Event|Empa|A single dose of empagliflozin (empa) 25 mg.
288841|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
288842|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
288843|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
288795|NCT01276288|B1|Baseline|Overall Patients|A randomised, open-label, multiple-dose, 2- way cross-over study. All patients received 25 mg empagliflozin in a form of a film-coated tablet orally once daily following an overnight fast of at least 10 hours (h) (days 1 to 5). Following a wash-out period of seven days, half of the patients received 25 mg hydrochlorothiazide (HCT) either on its own in a form of a film-coated tablet orally once daily (days 1 to 4) or in combination with 25 mg empagliflozin ( days 5 to 9), while the other half of the patients received 5 mg torasemide (TOR) either on its own (days 1 to 4) or in combination with the 25 mg empagliflozin ( days 5 to 9). This sequence was then reversed so that the HCT or TOR and its combination with 25 mg empagliflozin were administered first in a same manner as stated above, followed by 25 mg empagliflozin after seven days wash out period.
288796|NCT01276288|P4|Participant Flow|Empa+TOR/ Empa|Patients received 5mg torasemide (TOR) in combination with 25mg Empa. Following a wash-out period of seven days, 25 mg Empa was administered in a form of a film-coated tablet orally once daily following an overnight fast of at least 10 hours (h).
288797|NCT01276288|P3|Participant Flow|Empa/ Empa+ TOR|Patients received 25mg Empa in a form of a film-coated tablet orally once daily following an overnight fast of at least 10 hours (h). Following a wash-out period of seven days, 5 mg torasemide (TOR) in combination with 25mg Empa was administered.
288798|NCT01276288|P2|Participant Flow|Empa+HCT/ Empa|Patients received 25mg hydrochlorothiazide (HCT) in a form of a film-coated tablet orally once daily in combination with 25mg Empa. Following a wash-out period of seven days 25 mg Empa was administered in a form of a film-coated tablet orally once daily following an overnight fast of at least 10 hours (h).
288799|NCT01276288|P1|Participant Flow|Empa / Empa+HCT|Patients received 25mg empagliflozin (Empa) orally in a form of a film-coated tablet once daily following an overnight fast of at least 10 hours (h). Following a wash-out period of seven days, 25mg hydrochlorothiazide (HCT) in a form of a film-coated tablet was administered orally once daily in combination with 25mg Empa.
288800|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
288801|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
288802|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
288803|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
288804|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
288805|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
288806|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
288807|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
288808|NCT01276288|O6|Outcome|TOR-M3 + Empa|TOR metabolite which pharmacological activity is equal to TOR after TOR undergoes extensive hepatic metabolism in combination with Empa 25 mg
288809|NCT01276288|O5|Outcome|TOR-M1+ Empa|TOR metabolite with one-tenth of pharmacological activity of TOR after TOR undergoes extensive hepatic metabolism in combination with Empa 25 mg
288810|NCT01276288|O4|Outcome|TOR Metabolite (TOR-M3)|TOR metabolite which pharmacological activity is equal to TOR after TOR undergoes extensive hepatic metabolism.
288811|NCT01276288|O3|Outcome|TOR Metabolite (TOR-M1)|TOR metabolite with one-tenth of pharmacological activity of TOR after TOR undergoes extensive hepatic metabolism.
288812|NCT01276288|O2|Outcome|TOR+ Empa|Torasemide (TOR) 5 mg and Empagliflozin (Empa) 25 mg administered once daily for 5 days
288813|NCT01276288|O1|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
288814|NCT01276288|O6|Outcome|TOR-M3 + Empa|TOR metabolite which pharmacological activity is equal to TOR after TOR undergoes extensive hepatic metabolism in combination with Empa 25 mg
288815|NCT01276288|O5|Outcome|TOR-M1+ Empa|TOR metabolite with one-tenth of pharmacological activity of TOR after TOR undergoes extensive hepatic metabolism in combination with Empa 25 mg
288816|NCT01276288|O4|Outcome|TOR Metabolite (TOR-M3)|TOR metabolite which pharmacological activity is equal to TOR after TOR undergoes extensive hepatic metabolism.
288817|NCT01276288|O3|Outcome|TOR Metabolite (TOR-M1)|TOR metabolite with one-tenth of pharmacological activity of TOR after TOR undergoes extensive hepatic metabolism.
288818|NCT01276288|O2|Outcome|TOR+ Empa|Torasemide (TOR) 5 mg and Empagliflozin (Empa) 25 mg administered once daily for 5 days
288819|NCT01276288|O1|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
288820|NCT01276288|O2|Outcome|HCT+ Empa|Hydrochlorothiazide (HCT) 25 mg followed by Empagliflozin (Empa) 25 mg administered once daily for 5 days
288821|NCT01276288|O1|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
288822|NCT01276288|O2|Outcome|HCT+ Empa|Hydrochlorothiazide (HCT) 25 mg followed by Empagliflozin (Empa) 25 mg administered once daily for 5 days
288823|NCT01276288|O1|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
288824|NCT01276288|O3|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
288825|NCT01276288|O2|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
288826|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
288827|NCT01276288|O3|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
288828|NCT01276288|O2|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
288829|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
288830|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
288831|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
288832|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
288833|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
288834|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
288845|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
288846|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
288847|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
288848|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
288849|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
288850|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
288851|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
288852|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
288853|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
288854|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
288855|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
288856|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
288857|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
288858|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
288859|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
288860|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
288861|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
288862|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
288863|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
288864|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
288865|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
288866|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
288867|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
288868|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
288869|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
288870|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
288871|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
288872|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
288873|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
288874|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
288875|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
288876|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
288877|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
288878|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
288879|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
288880|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
288881|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
288882|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
288883|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
288884|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
288885|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
288886|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
288887|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
288888|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
288889|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
288890|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
288891|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
288892|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
288893|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
288894|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
288895|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
288896|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
288897|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
288898|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
288899|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
288900|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
288901|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
288902|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
288903|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
288904|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
288905|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
288906|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
288907|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
288908|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
288909|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
288910|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
288911|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
288912|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
288913|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
288914|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
288915|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
288916|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
288917|NCT01276288|E5|Reported Event|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
288918|NCT01276288|E4|Reported Event|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
288919|NCT01276288|E3|Reported Event|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
288920|NCT01276288|E2|Reported Event|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
288921|NCT01276288|E1|Reported Event|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
288922|NCT01276223|B4|Baseline|Total|Total of all reporting groups
288923|NCT01276223|B3|Baseline|Vehicle|Difluprednate vehicle (Run-In), followed by difluprednate vehicle (treatment)
288924|NCT01276223|B2|Baseline|Durezol|Difluprednate vehicle (Run-in), followed by difluprednate 0.05% ophthalmic emulsion (treatment)
288925|NCT01276223|B1|Baseline|Run-In Only|Difluprednate vehicle
288926|NCT01276223|P3|Participant Flow|Vehicle|Difluprednate vehicle (Run-In), followed by difluprednate vehicle (treatment)
288927|NCT01276223|P2|Participant Flow|Durezol|Difluprednate vehicle (Run-in), followed by difluprednate 0.05% ophthalmic emulsion (treatment)
288928|NCT01276223|P1|Participant Flow|Run-In Only|Difluprednate vehicle
288929|NCT01276223|O2|Outcome|Vehicle|Difluprednate vehicle
288930|NCT01276223|O1|Outcome|Durezol|Difluprednate 0.5% ophthalmic emulsion
288931|NCT01276223|E3|Reported Event|Vehicle|Difluprednate vehicle
288932|NCT01276223|E2|Reported Event|Durezol|Difluprednate 0.05% ophthalmic emulsion
288933|NCT01276223|E1|Reported Event|Run-In|Difluprednate vehicle, all patients
288934|NCT01276197|B3|Baseline|Total|Total of all reporting groups
288935|NCT01276197|B2|Baseline|Arm 2: Non-Storytelling DVD|"Participant will receive an informational DVD~Non-Storytelling DVD: DVD will contain only informational component."
288936|NCT01276197|B1|Baseline|Arm 1: Story-Telling DVD|"Participant will receive a DVD with informational and story-telling components~Story-Telling DVD: DVD will contain both informational and story-telling components."
288937|NCT01276197|P2|Participant Flow|Arm 2: Non-Storytelling DVD|"Participant will receive an informational DVD~Non-Storytelling DVD: DVD will contain only informational component."
288938|NCT01276197|P1|Participant Flow|Arm 1: Story-Telling DVD|"Participant will receive a DVD with informational and story-telling components~Story-Telling DVD: DVD will contain both informational and story-telling components."
288939|NCT01276197|O2|Outcome|Arm 2: Non-Storytelling DVD|"Participant will receive an informational DVD~Non-Storytelling DVD: DVD will contain only informational component."
288940|NCT01276197|O1|Outcome|Arm 1: Story-Telling DVD|"Participant will receive a DVD with informational and story-telling components~Story-Telling DVD: DVD will contain both informational and story-telling components."
288941|NCT01276197|O2|Outcome|Arm 2: Non-Storytelling DVD|"Participant will receive an informational DVD~Non-Storytelling DVD: DVD will contain only informational component."
288942|NCT01276197|O1|Outcome|Arm 1: Story-Telling DVD|"Participant will receive a DVD with informational and story-telling components~Story-Telling DVD: DVD will contain both informational and story-telling components."
288943|NCT01276197|E2|Reported Event|Arm 2: Non-Storytelling DVD|"Participant will receive an informational DVD~Non-Storytelling DVD: DVD will contain only informational component."
288944|NCT01276197|E1|Reported Event|Arm 1: Story-Telling DVD|"Participant will receive a DVD with informational and story-telling components~Story-Telling DVD: DVD will contain both informational and story-telling components."
288945|NCT01276171|B4|Baseline|Total|Total of all reporting groups
288946|NCT01276171|B3|Baseline|Palpation|"Participants will place arterial line using palpation technique~Palpation: Participants will place arterial line using Palpation technique"
288947|NCT01276171|B2|Baseline|Doppler|"Participants will place arterial line using doppler technique~Doppler: Participants will place arterial line using doppler technique"
288948|NCT01276171|B1|Baseline|Ultrasound|"Participants will place arterial line using ultrasound technique~Ultrasound: Participants will place arterial line using ultrasound technique"
288949|NCT01276171|P3|Participant Flow|Palpation|"Participants will place arterial line using palpation technique~Palpation: Participants will place arterial line using Palpation technique"
288950|NCT01276171|P2|Participant Flow|Doppler|"Participants will place arterial line using doppler technique~Doppler: Participants will place arterial line using doppler technique"
288951|NCT01276171|P1|Participant Flow|Ultrasound|"Participants will place arterial line using ultrasound technique~Ultrasound: Participants will place arterial line using ultrasound technique"
288952|NCT01276171|O3|Outcome|Palpation|"Participants will place arterial line using palpation technique~Palpation: Participants will place arterial line using Palpation technique"
288953|NCT01276171|O2|Outcome|Doppler|"Participants will place arterial line using doppler technique~Doppler: Participants will place arterial line using doppler technique"
288954|NCT01276171|O1|Outcome|Ultrasound|"Participants will place arterial line using ultrasound technique~Ultrasound: Participants will place arterial line using ultrasound technique"
288955|NCT01276171|O3|Outcome|Palpation|"Participants will place arterial line using palpation technique~Palpation: Participants will place arterial line using Palpation technique"
288956|NCT01276171|O2|Outcome|Doppler|"Participants will place arterial line using doppler technique~Doppler: Participants will place arterial line using doppler technique"
288957|NCT01276171|O1|Outcome|Ultrasound|"Participants will place arterial line using ultrasound technique~Ultrasound: Participants will place arterial line using ultrasound technique"
288958|NCT01276171|O3|Outcome|Palpation|"Participants will place arterial line using palpation technique~Palpation: Participants will place arterial line using Palpation technique"
288959|NCT01276171|O2|Outcome|Doppler|"Participants will place arterial line using doppler technique~Doppler: Participants will place arterial line using doppler technique"
288960|NCT01276171|O1|Outcome|Ultrasound|"Participants will place arterial line using ultrasound technique~Ultrasound: Participants will place arterial line using ultrasound technique"
288961|NCT01276171|E3|Reported Event|Palpation|"Participants will place arterial line using palpation technique~Palpation: Participants will place arterial line using Palpation technique"
288962|NCT01276171|E2|Reported Event|Doppler|"Participants will place arterial line using doppler technique~Doppler: Participants will place arterial line using doppler technique"
288963|NCT01276171|E1|Reported Event|Ultrasound|"Participants will place arterial line using ultrasound technique~Ultrasound: Participants will place arterial line using ultrasound technique"
288964|NCT01276106|B5|Baseline|Total|Total of all reporting groups
288965|NCT01276106|B4|Baseline|Placebo|Placebo: Capsule, BID
288966|NCT01276106|B3|Baseline|AC-201, 75mg BID|AC-201: Capsule, 75mg BID
288967|NCT01276106|B2|Baseline|AC-201, 50mg BID|AC-201: Capsule, 50mg BID
288968|NCT01276106|B1|Baseline|AC-201, 25mg BID|AC-201: Capsule, 25mg BID
288969|NCT01276106|P4|Participant Flow|Placebo|Placebo: Capsule, BID
288970|NCT01276106|P3|Participant Flow|AC-201, 75mg BID|AC-201: Capsule, 75mg BID
288971|NCT01276106|P2|Participant Flow|AC-201, 50mg BID|AC-201: Capsule, 50mg BID
288972|NCT01276106|P1|Participant Flow|AC-201, 25mg BID|AC-201: Capsule, 25mg BID
288973|NCT01276106|O4|Outcome|Placebo|Placebo: Capsule, BID
288974|NCT01276106|O3|Outcome|AC-201, 75mg BID|AC-201: Capsule, 75mg BID
288975|NCT01276106|O2|Outcome|AC-201, 50mg BID|AC-201: Capsule, 50mg BID
288976|NCT01276106|O1|Outcome|AC-201, 25mg BID|AC-201: Capsule, 25mg BID
288977|NCT01276106|E4|Reported Event|Placebo|Placebo: Capsule, BID
288978|NCT01276106|E3|Reported Event|AC-201, 75mg BID|AC-201: Capsule, 75mg BID
288979|NCT01276106|E2|Reported Event|AC-201, 50mg BID|AC-201: Capsule, 50mg BID
288980|NCT01276106|E1|Reported Event|AC-201, 25mg BID|AC-201: Capsule, 25mg BID
288981|NCT01276054|B3|Baseline|Total|Total of all reporting groups
288982|NCT01276054|B2|Baseline|SNB or ALND (+/- SNB)|"Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies"
288983|NCT01276054|B1|Baseline|SNB Plus ARM or ALND (+/- SNB) Plus ARM|"Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies~lymphedema management: Undergo axillary reverse mapping"
288984|NCT01276054|P2|Participant Flow|SNB or ALND (+/- SNB)|"Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies"
288985|NCT01276054|P1|Participant Flow|SNB Plus ARM or ALND (+/- SNB) Plus ARM|"Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies~lymphedema management: Undergo axillary reverse mapping"
289028|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
289220|NCT01274897|P1|Participant Flow|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
288986|NCT01276054|O2|Outcome|SNB or ALND (+/- SNB)|"Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies"
288987|NCT01276054|O1|Outcome|SNB Plus ARM or ALND (+/- SNB) Plus ARM|"Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies~lymphedema management: Undergo axillary reverse mapping"
288988|NCT01276054|E2|Reported Event|SNB or ALND (+/- SNB)|"Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies"
288989|NCT01276054|E1|Reported Event|SNB Plus ARM or ALND (+/- SNB) Plus ARM|"Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies~lymphedema management: Undergo axillary reverse mapping"
288990|NCT01275833|B3|Baseline|Total|Total of all reporting groups
288991|NCT01275833|B2|Baseline|Device Programming Allows Intrinsic AV Timing.|VVI-40-RV
288992|NCT01275833|B1|Baseline|Device Programming Modifies AV Timing|"DDD-40-BiV~Cardiac resynchronization therapy-defibrillator: Device programming that modifies AV timing"
288993|NCT01275833|P2|Participant Flow|Device Programming That Allows Intrinsic AV Timing.|Cardiac resynchronization therapy-defibrillator: Device programming that does not modifies AV timing
288994|NCT01275833|P1|Participant Flow|Device Programming That Modifies AV Timing|Cardiac resynchronization therapy-defibrillator: Device programming that modifies AV timing
288995|NCT01275833|O2|Outcome|Device Programming That Allows Intrinsic AV Timing.|Cardiac resynchronization therapy-defibrillator: Device programming that does not modifies AV timing
288996|NCT01275833|O1|Outcome|Device Programming That Modifies AV Timing|Cardiac resynchronization therapy-defibrillator: Device programming that modifies AV timing
288997|NCT01275833|E2|Reported Event|Device Programming That Allows Intrinsic AV Timing.|Cardiac resynchronization therapy-defibrillator: Device programming that does not modifies AV timing
288998|NCT01275833|E1|Reported Event|Device Programming That Modifies AV Timing|Cardiac resynchronization therapy-defibrillator: Device programming that modifies AV timing
288999|NCT01275755|B3|Baseline|Total|Total of all reporting groups
289000|NCT01275755|B2|Baseline|ADL5945 0.25mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
289001|NCT01275755|B1|Baseline|Placebo|Each participant received 1 placebo capsule orally QD during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
289002|NCT01275755|P2|Participant Flow|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-milligrams (mg) ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
289003|NCT01275755|P1|Participant Flow|Placebo|Each participant received 1 placebo capsule orally every day (QD) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
289004|NCT01275755|O2|Outcome|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
289005|NCT01275755|O1|Outcome|Placebo|Each participant received 1 placebo capsule orally QD during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
289006|NCT01275755|E2|Reported Event|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-milligrams (mg) ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
289007|NCT01275755|E1|Reported Event|Placebo|Each participant received 1 placebo capsule orally every day (QD) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
289008|NCT01275664|B1|Baseline|Treatment (Granisetron, Dexamethasone, Aprepitant)|"Patients apply one patch of granisetron transdermal system to the upper outer arm on day 0 (at least 24 hours before intraperitoneal [IP] platinum therapy). Patients then receive dexamethasone PO on days 1-4, aprepitant IV over 15 minutes on day 1 (30 minutes before IP platinum therapy), and aprepitant PO on days 2-3.~Adjuvant Therapy: Ancillary studies~Aprepitant: Given IV and PO~Carboplatin: Given IP~Cisplatin: Given IP~Dexamethasone: Given PO~Granisetron Transdermal Patch: Apply one patch to upper arm~Management of Therapy Complications: Ancillary studies~Questionnaire Administration: Ancillary studies"
289009|NCT01275664|P1|Participant Flow|Treatment (Granisetron, Dexamethasone, Aprepitant)|"Patients apply one patch of granisetron transdermal system to the upper outer arm on day 0 (at least 24 hours before intraperitoneal [IP] platinum therapy). Patients then receive dexamethasone PO on days 1-4, aprepitant IV over 15 minutes on day 1 (30 minutes before IP platinum therapy), and aprepitant PO on days 2-3.~Adjuvant Therapy: Ancillary studies~Aprepitant: Given IV and PO~Carboplatin: Given IP~Cisplatin: Given IP~Dexamethasone: Given PO~Granisetron Transdermal Patch: Apply one patch to upper arm~Management of Therapy Complications: Ancillary studies~Questionnaire Administration: Ancillary studies"
289010|NCT01275664|O1|Outcome|Treatment (Granisetron, Dexamethasone, Aprepitant)|"Patients apply one patch of granisetron transdermal system to the upper outer arm on day 0 (at least 24 hours before intraperitoneal [IP] platinum therapy). Patients then receive dexamethasone PO on days 1-4, aprepitant IV over 15 minutes on day 1 (30 minutes before IP platinum therapy), and aprepitant PO on days 2-3.~Adjuvant Therapy: Ancillary studies~Aprepitant: Given IV and PO~Carboplatin: Given IP~Cisplatin: Given IP~Dexamethasone: Given PO~Granisetron Transdermal Patch: Apply one patch to upper arm~Management of Therapy Complications: Ancillary studies~Questionnaire Administration: Ancillary studies"
289011|NCT01275664|O1|Outcome|Treatment (Granisetron, Dexamethasone, Aprepitant)|"Patients apply one patch of granisetron transdermal system to the upper outer arm on day 0 (at least 24 hours before intraperitoneal [IP] platinum therapy). Patients then receive dexamethasone PO on days 1-4, aprepitant IV over 15 minutes on day 1 (30 minutes before IP platinum therapy), and aprepitant PO on days 2-3.~Adjuvant Therapy: Ancillary studies~Aprepitant: Given IV and PO~Carboplatin: Given IP~Cisplatin: Given IP~Dexamethasone: Given PO~Granisetron Transdermal Patch: Apply one patch to upper arm~Management of Therapy Complications: Ancillary studies~Questionnaire Administration: Ancillary studies"
289012|NCT01275664|O1|Outcome|Treatment (Granisetron, Dexamethasone, Aprepitant)|"Patients apply one patch of granisetron transdermal system to the upper outer arm on day 0 (at least 24 hours before intraperitoneal [IP] platinum therapy). Patients then receive dexamethasone PO on days 1-4, aprepitant IV over 15 minutes on day 1 (30 minutes before IP platinum therapy), and aprepitant PO on days 2-3.~Adjuvant Therapy: Ancillary studies~Aprepitant: Given IV and PO~Carboplatin: Given IP~Cisplatin: Given IP~Dexamethasone: Given PO~Granisetron Transdermal Patch: Apply one patch to upper arm~Management of Therapy Complications: Ancillary studies~Questionnaire Administration: Ancillary studies"
289013|NCT01275664|O1|Outcome|Treatment (Granisetron, Dexamethasone, Aprepitant)|"Patients apply one patch of granisetron transdermal system to the upper outer arm on day 0 (at least 24 hours before intraperitoneal [IP] platinum therapy). Patients then receive dexamethasone PO on days 1-4, aprepitant IV over 15 minutes on day 1 (30 minutes before IP platinum therapy), and aprepitant PO on days 2-3.~Adjuvant Therapy: Ancillary studies~Aprepitant: Given IV and PO~Carboplatin: Given IP~Cisplatin: Given IP~Dexamethasone: Given PO~Granisetron Transdermal Patch: Apply one patch to upper arm~Management of Therapy Complications: Ancillary studies~Questionnaire Administration: Ancillary studies"
289014|NCT01275664|O1|Outcome|Treatment (Granisetron, Dexamethasone, Aprepitant)|"Patients apply one patch of granisetron transdermal system to the upper outer arm on day 0 (at least 24 hours before intraperitoneal [IP] platinum therapy). Patients then receive dexamethasone PO on days 1-4, aprepitant IV over 15 minutes on day 1 (30 minutes before IP platinum therapy), and aprepitant PO on days 2-3.~Adjuvant Therapy: Ancillary studies~Aprepitant: Given IV and PO~Carboplatin: Given IP~Cisplatin: Given IP~Dexamethasone: Given PO~Granisetron Transdermal Patch: Apply one patch to upper arm~Management of Therapy Complications: Ancillary studies~Questionnaire Administration: Ancillary studies"
289015|NCT01275664|E1|Reported Event|Treatment (Granisetron, Dexamethasone, Aprepitant)|"Patients apply one patch of granisetron transdermal system to the upper outer arm on day 0 (at least 24 hours before intraperitoneal [IP] platinum therapy). Patients then receive dexamethasone PO on days 1-4, aprepitant IV over 15 minutes on day 1 (30 minutes before IP platinum therapy), and aprepitant PO on days 2-3.~Adjuvant Therapy: Ancillary studies~Aprepitant: Given IV and PO~Carboplatin: Given IP~Cisplatin: Given IP~Dexamethasone: Given PO~Granisetron Transdermal Patch: Apply one patch to upper arm~Management of Therapy Complications: Ancillary studies~Questionnaire Administration: Ancillary studies"
289016|NCT01275625|B1|Baseline|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
289017|NCT01275625|P1|Participant Flow|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
289018|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
289019|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
289020|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
289021|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
289022|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
289023|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
289024|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
289025|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
289026|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
289027|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
289029|NCT01275625|E1|Reported Event|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
289030|NCT01275586|B1|Baseline|Tasigna|Following enrollment each subject will initially receive Tasigna orally at 200 mg twice daily for two weeks. If tolerated, the dose will be increased to 300 mg twice daily after a minimum of two weeks and will be increase to a maximum dose of 400mg twice daily after an additional two weeks if tolerated.
289031|NCT01275586|P1|Participant Flow|Tasigna|Following enrollment each subject will initially receive Tasigna orally at 200 mg twice daily for two weeks. If tolerated, the dose will be increased to 300 mg twice daily after a minimum of two weeks and will be increase to a maximum dose of 400mg twice daily after an additional two weeks if tolerated.
289032|NCT01275586|O1|Outcome|Tasigna|Following enrollment each subject will initially receive Tasigna orally at 200 mg twice daily for two weeks. If tolerated, the dose will be increased to 300 mg twice daily after a minimum of two weeks and will be increase to a maximum dose of 400mg twice daily after an additional two weeks if tolerated.
289033|NCT01275586|E1|Reported Event|Tasigna|Following enrollment each subject will initially receive Tasigna orally at 200 mg twice daily for two weeks. If tolerated, the dose will be increased to 300 mg twice daily after a minimum of two weeks and will be increase to a maximum dose of 400mg twice daily after an additional two weeks if tolerated.
289034|NCT01275430|B1|Baseline|Sherlock 3CG|"Sherlock 3CG is indicated for central venous catheter guidance and positioning during catheter placement. The Sherlock 3CG provides real time catheter tip location information through the use of passive magnet and cardiac electrical signal detection.~Randomization did not occur due to early termination. All participants were assigned to Sherlock 3CG in phase I. Randomization would have occurred at the start of Phase II, but Phase II was not initiated due to early termination."
289035|NCT01275430|P1|Participant Flow|Sherlock 3CG|"Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System.~All participants were assigned to Sherlock 3CG in Phase I. Zero subjects started Phase II because of early termination of the study, so zero subjects were randomized. All adverse event reporting is also for Phase I (3CG) participants."
289036|NCT01275430|O1|Outcome|Sherlock 3CG|Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System
289037|NCT01275430|O1|Outcome|Sherlock 3CG|Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System
289038|NCT01275430|O1|Outcome|Sherlock 3CG|Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System
289039|NCT01275430|O1|Outcome|Sherlock 3CG|Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System
289040|NCT01275430|O1|Outcome|Sherlock 3CG|Mean distance (mm) from the PICC tip to the upper Caval Atrial junction upon observation of maximum p-wave amplitude when using Sherlock 3CG.
289041|NCT01275430|E1|Reported Event|Sherlock 3CG|"Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System~All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study."
289042|NCT01275365|B5|Baseline|Total|Total of all reporting groups
289043|NCT01275365|B4|Baseline|Testosterone/High Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
289044|NCT01275365|B3|Baseline|Testosterone/Low Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
289045|NCT01275365|B2|Baseline|Placebo/High Protein|Placebo injections weekly; 1.3 g/kg/day protein
289046|NCT01275365|B1|Baseline|Placebo/Low Protein|Placebo injections weekly; 0.8 g/kg/day protein
289047|NCT01275365|P4|Participant Flow|Testosterone/High Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
289048|NCT01275365|P3|Participant Flow|Testosterone/Low Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
289049|NCT01275365|P2|Participant Flow|Placebo/High Protein|Placebo injections weekly; 1.3 g/kg/day protein
289050|NCT01275365|P1|Participant Flow|Placebo/Low Protein|Placebo injections weekly; 0.8 g/kg/day protein
289051|NCT01275365|O4|Outcome|Testosterone/High Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
289052|NCT01275365|O3|Outcome|Testosterone/Low Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
289053|NCT01275365|O2|Outcome|Placebo/High Protein|Placebo injections weekly; 1.3 g/kg/day protein
289054|NCT01275365|O1|Outcome|Placebo/Low Protein|Placebo injections weekly; 0.8 g/kg/day protein
289055|NCT01275365|O4|Outcome|Testosterone/High Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
289056|NCT01275365|O3|Outcome|Testosterone/Low Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
289057|NCT01275365|O2|Outcome|Placebo/High Protein|Placebo injections weekly; 1.3 g/kg/day protein
289058|NCT01275365|O1|Outcome|Placebo/Low Protein|Placebo injections weekly; 0.8 g/kg/day protein
289059|NCT01275365|O4|Outcome|Testosterone/High Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
289060|NCT01275365|O3|Outcome|Testosterone/Low Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
289061|NCT01275365|O2|Outcome|Placebo/High Protein|Placebo injections weekly; 1.3 g/kg/day protein
289062|NCT01275365|O1|Outcome|Placebo/Low Protein|Placebo injections weekly; 0.8 g/kg/day protein
289063|NCT01275365|O4|Outcome|Testosterone/High Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
289064|NCT01275365|O3|Outcome|Testosterone/Low Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
289065|NCT01275365|O2|Outcome|Placebo/High Protein|Placebo injections weekly; 1.3 g/kg/day protein
289066|NCT01275365|O1|Outcome|Placebo/Low Protein|Placebo injections weekly; 0.8 g/kg/day protein
289067|NCT01275365|O4|Outcome|Testosterone/High Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
289068|NCT01275365|O3|Outcome|Testosterone/Low Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
289069|NCT01275365|O2|Outcome|Placebo/High Protein|Placebo injections weekly; 1.3 g/kg/day protein
289070|NCT01275365|O1|Outcome|Placebo/Low Protein|Placebo injections weekly; 0.8 g/kg/day protein
289071|NCT01275365|O4|Outcome|Testosterone/High Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
289072|NCT01275365|O3|Outcome|Testosterone/Low Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
289073|NCT01275365|O2|Outcome|Placebo/High Protein|Placebo injections weekly; 1.3 g/kg/day protein
289074|NCT01275365|O1|Outcome|Placebo/Low Protein|Placebo injections weekly; 0.8 g/kg/day protein
289075|NCT01275365|O4|Outcome|Testosterone/High Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
289076|NCT01275365|O3|Outcome|Testosterone/Low Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
289077|NCT01275365|O2|Outcome|Placebo/High Protein|Placebo injections weekly; 1.3 g/kg/day protein
289078|NCT01275365|O1|Outcome|Placebo/Low Protein|Placebo injections weekly; 0.8 g/kg/day protein
289079|NCT01275365|O4|Outcome|Testosterone/High Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
289080|NCT01275365|O3|Outcome|Testosterone/Low Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
289081|NCT01275365|O2|Outcome|Placebo/High Protein|Placebo injections weekly; 1.3 g/kg/day protein
289082|NCT01275365|O1|Outcome|Placebo/Low Protein|Placebo injections weekly; 0.8 g/kg/day protein
289083|NCT01275365|O4|Outcome|Testosterone/High Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
289084|NCT01275365|O3|Outcome|Testosterone/Low Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
289085|NCT01275365|O2|Outcome|Placebo/High Protein|Placebo injections weekly; 1.3 g/kg/day protein
289086|NCT01275365|O1|Outcome|Placebo/Low Protein|Placebo injections weekly; 0.8 g/kg/day protein
289087|NCT01275365|O4|Outcome|Testosterone/High Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
289088|NCT01275365|O3|Outcome|Testosterone/Low Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
289089|NCT01275365|O2|Outcome|Placebo/High Protein|Placebo injections weekly; 1.3 g/kg/day protein
289090|NCT01275365|O1|Outcome|Placebo/Low Protein|Placebo injections weekly; 0.8 g/kg/day protein
289091|NCT01275365|E4|Reported Event|Testosterone/High Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
289092|NCT01275365|E3|Reported Event|Testosterone/Low Protein|"Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein~Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly"
289093|NCT01275365|E2|Reported Event|Placebo/High Protein|Placebo injections weekly; 1.3 g/kg/day protein
289094|NCT01275365|E1|Reported Event|Placebo/Low Protein|Placebo injections weekly; 0.8 g/kg/day protein
289095|NCT01275313|B3|Baseline|Total|Total of all reporting groups
289096|NCT01275313|B2|Baseline|Cushion Only|"Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair~Skin Protection Cushion: Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion"
289097|NCT01275313|B1|Baseline|Custom-Fitted Lightweight Wheelchair & Cushion|"Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training~Lightweight wheelchair: Seating and wheeled mobility assessment and fitting of a lightweight wheelchair"
289098|NCT01275313|P2|Participant Flow|Cushion Only|"Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair~Skin Protection Cushion: Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion"
289099|NCT01275313|P1|Participant Flow|Custom-Fitted Lightweight Wheelchair & Cushion|"Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training~Lightweight wheelchair: Seating and wheeled mobility assessment and fitting of a lightweight wheelchair"
289100|NCT01275313|O2|Outcome|Cushion Only|"Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair~Skin Protection Cushion: Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion"
289101|NCT01275313|O1|Outcome|Custom-Fitted Lightweight Wheelchair & Cushion|"Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training~Lightweight wheelchair: Seating and wheeled mobility assessment and fitting of a lightweight wheelchair"
289102|NCT01275313|E2|Reported Event|Cushion Only|"Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair~Skin Protection Cushion: Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion"
289221|NCT01274897|O2|Outcome|Placebo|Subjects received the saline placebo.
289222|NCT01274897|O1|Outcome|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
289103|NCT01275313|E1|Reported Event|Custom-Fitted Lightweight Wheelchair & Cushion|"Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training~Lightweight wheelchair: Seating and wheeled mobility assessment and fitting of a lightweight wheelchair"
289104|NCT01275196|B3|Baseline|Total|Total of all reporting groups
289105|NCT01275196|B2|Baseline|Nilotinib|Patients received 300 mg bid (600 mg/day)
289106|NCT01275196|B1|Baseline|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
289107|NCT01275196|P2|Participant Flow|Nilotinib|Patients received 300 mg bid (600 mg/day)
289108|NCT01275196|P1|Participant Flow|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
289109|NCT01275196|O3|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
289110|NCT01275196|O2|Outcome|CGP74588|Major metabolite of Imatinib
289111|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
289112|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
289113|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
289114|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
289115|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
289116|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
289117|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
289118|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
289119|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
289120|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
289121|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
289122|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
289123|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
289124|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
289125|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
289126|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
289127|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
289128|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
289129|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
289130|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
289131|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
289132|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
289133|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
289134|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
289135|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
289136|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
289137|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
289138|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
289139|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
289140|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
289141|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
289142|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
289143|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
289144|NCT01275196|E2|Reported Event|Nilotinib 300 mg Bid|Patients received 300 mg bid (600 mg/day)
289145|NCT01275196|E1|Reported Event|Imatinib 400 mg qd|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
289146|NCT01275131|B5|Baseline|Total|Total of all reporting groups
289147|NCT01275131|B4|Baseline|Stage 3: Insulin Aspart + rHuPH20 First, Then Insulin Aspart|"Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a 1.0-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the euglycemic clamp .~After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII, for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a sham injection was administered 2.5 hr prior to a 6-hr euglycemic clamp."
289148|NCT01275131|B3|Baseline|Stage 3: Insulin Aspart First, Then Insulin Aspart + rHuPH20|"Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.~After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a 1.0-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to a 6-hr euglycemic clamp."
289149|NCT01275131|B2|Baseline|Stage 1: Insulin Aspart-rHuPH20 First, Then Insulin Aspart|"Participants first received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4.~After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart alone as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8."
326933|NCT01180777|O1|Outcome|Etafilcon A (A)|Daily wear contact lens
289150|NCT01275131|B1|Baseline|Stage 1: Insulin Aspart First, Then Insulin Aspart-rHuPH20|"Participants first received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4.~After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8."
289151|NCT01275131|P4|Participant Flow|Stage 3: Insulin Aspart + rHuPH20 First, Then Insulin Aspart|"Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a 1.0 milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp .~After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII, for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp."
289152|NCT01275131|P3|Participant Flow|Stage 3: Insulin Aspart First, Then Insulin Aspart + rHuPH20|"Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.~After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII, for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a 1.0 milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp."
289153|NCT01275131|P2|Participant Flow|Stage 1: Insulin Aspart-rHuPH20 First, Then Insulin Aspart|"Participants first received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4.~After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart alone as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8."
289154|NCT01275131|P1|Participant Flow|Stage 1: Insulin Aspart First, Then Insulin Aspart-rHuPH20|"Participants first received 0.15 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4.~After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart and 5-micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8."
289155|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
289156|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
289157|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
289158|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6 hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
289159|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
289160|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
289161|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
289162|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
289179|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
289163|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
289164|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
289165|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
289166|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
289167|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1 milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
289168|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6 hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
289169|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days, including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 or Days 6 and 8.
289170|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
289171|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
289172|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
289173|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
289174|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
289175|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
289176|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
289177|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1 milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
289178|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
289211|NCT01275066|E1|Reported Event|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
289180|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Day 6 and 8 of Period 2.
289181|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2
289182|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2
289183|NCT01275131|E4|Reported Event|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1 or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
289184|NCT01275131|E3|Reported Event|Stage 3: Insulin Aspart|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3 and 5 of Period 1 or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
289185|NCT01275131|E2|Reported Event|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
289186|NCT01275131|E1|Reported Event|Stage 1: Insulin Aspart|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
289187|NCT01275092|B1|Baseline|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
289188|NCT01275092|P1|Participant Flow|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
289189|NCT01275092|O1|Outcome|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
289190|NCT01275092|O1|Outcome|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
289191|NCT01275092|O1|Outcome|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
289192|NCT01275092|E1|Reported Event|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
289193|NCT01275066|B4|Baseline|Total|Total of all reporting groups
289194|NCT01275066|B3|Baseline|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
289195|NCT01275066|B2|Baseline|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
289196|NCT01275066|B1|Baseline|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
289197|NCT01275066|P3|Participant Flow|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
289198|NCT01275066|P2|Participant Flow|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
289199|NCT01275066|P1|Participant Flow|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
289200|NCT01275066|O3|Outcome|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
289201|NCT01275066|O2|Outcome|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
289202|NCT01275066|O1|Outcome|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
289203|NCT01275066|O3|Outcome|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
289204|NCT01275066|O2|Outcome|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
289205|NCT01275066|O1|Outcome|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
289206|NCT01275066|O3|Outcome|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
289207|NCT01275066|O2|Outcome|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
289208|NCT01275066|O1|Outcome|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
289209|NCT01275066|E3|Reported Event|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
289210|NCT01275066|E2|Reported Event|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
289212|NCT01275053|B1|Baseline|Leptin|leptin: 0.01mg/kg
289213|NCT01275053|P1|Participant Flow|Leptin|leptin: 0.01mg/kg
289223|NCT01274897|O2|Outcome|Placebo|Subjects received the saline placebo.
289224|NCT01274897|O1|Outcome|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
289225|NCT01274897|O2|Outcome|Placebo|Subjects received the saline placebo.
289226|NCT01274897|O1|Outcome|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
289227|NCT01274897|O2|Outcome|Placebo|Subjects received the saline placebo.
289228|NCT01274897|O1|Outcome|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
289229|NCT01274897|E2|Reported Event|Placebo|Subjects received the saline placebo.
289230|NCT01274897|E1|Reported Event|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
289231|NCT01274715|B1|Baseline|Behavioral Health Coaching|Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
289232|NCT01274715|P1|Participant Flow|Behavioral Health Coaching|Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
289233|NCT01274715|O1|Outcome|Behavioral Health Coaching|Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
289234|NCT01274715|O1|Outcome|Behavioral Health Coaching|Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
289235|NCT01274715|E1|Reported Event|Behavioral Health Coaching|Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
289236|NCT01274637|B3|Baseline|Total|Total of all reporting groups
289237|NCT01274637|B2|Baseline|Control Group|No treatment control group.
289238|NCT01274637|B1|Baseline|Low Molecular Weight Heparin|"Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.~Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes."
289239|NCT01274637|P2|Participant Flow|Control Group|No treatment control group.
289240|NCT01274637|P1|Participant Flow|Low Molecular Weight Heparin|"Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.~Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes."
289241|NCT01274637|O2|Outcome|Control Group|No treatment control group.
289242|NCT01274637|O1|Outcome|Low Molecular Weight Heparin|"Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.~Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes."
289243|NCT01274637|O2|Outcome|Control Group|No treatment control group.
289244|NCT01274637|O1|Outcome|Low Molecular Weight Heparin|"Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.~Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes."
289245|NCT01274637|O2|Outcome|Control Group|No treatment control group.
289246|NCT01274637|O1|Outcome|Low Molecular Weight Heparin|"Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.~Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes."
289247|NCT01274637|O2|Outcome|Control Group|No treatment control group.
289248|NCT01274637|O1|Outcome|Low Molecular Weight Heparin|"Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.~Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes."
289249|NCT01274637|O2|Outcome|Control Group|No treatment control group.
289250|NCT01274637|O1|Outcome|Low Molecular Weight Heparin|"Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.~Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes."
289251|NCT01274637|O2|Outcome|Control Group|No treatment control group.
289252|NCT01274637|O1|Outcome|Low Molecular Weight Heparin|"Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.~Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes."
289253|NCT01274637|E2|Reported Event|Control Group|No treatment control group.
289254|NCT01274637|E1|Reported Event|Low Molecular Weight Heparin|"Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.~Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes."
289255|NCT01274611|B1|Baseline|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual axilla within each subject to receive either Botox treatment or suction-curettage treatment.~Botox wase injected into one underarm, targeting the sweat glands, to stop underarm sweating.~For Suction-Curettage, the doctor inserted a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating."
289293|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
289294|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
289295|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
289256|NCT01274611|P1|Participant Flow|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual axilla within each subject to receive either Botox treatment or suction-curettage treatment.~Botox was injected into one underarm, targeting the sweat glands, to stop underarm sweating.~For Suction-Curettage, the doctor inserted a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating."
289257|NCT01274611|O2|Outcome|Suction-Curettage|The doctor inserted a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating.
289258|NCT01274611|O1|Outcome|Botox|Botox was injected into the underarm, targeting the sweat glands, to stop underarm sweating.
289259|NCT01274611|O2|Outcome|Suction-Curettage|The doctor inserted a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating.
289260|NCT01274611|O1|Outcome|Botox|Botox was injected into the underarm, targeting the sweat glands, to stop underarm sweating.
289261|NCT01274611|E2|Reported Event|Suction-Curettage|The doctor inserted a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating.
289262|NCT01274611|E1|Reported Event|Botox|Botox was injected into the underarm, targeting the sweat glands, to stop underarm sweating.
289263|NCT01274585|B3|Baseline|Total|Total of all reporting groups
289264|NCT01274585|B2|Baseline|Stimulation/Treatment|Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
289265|NCT01274585|B1|Baseline|No Active Treatment|Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
289266|NCT01274585|P2|Participant Flow|Stimulation/Treatment|Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
289267|NCT01274585|P1|Participant Flow|No Active Treatment|Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
289268|NCT01274585|O2|Outcome|Stimulation/Treatment|Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
289269|NCT01274585|O1|Outcome|No Active Treatment|Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
289270|NCT01274585|O2|Outcome|Stimulation/Treatment|Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
289271|NCT01274585|O1|Outcome|No Active Treatment|Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
289272|NCT01274585|O2|Outcome|Stimulation/Treatment|Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
289273|NCT01274585|O1|Outcome|No Active Treatment|Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
289274|NCT01274585|E2|Reported Event|Stimulation/Treatment|Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
289275|NCT01274585|E1|Reported Event|No Active Treatment|Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
289276|NCT01274559|B3|Baseline|Total|Total of all reporting groups
289277|NCT01274559|B2|Baseline|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
289278|NCT01274559|B1|Baseline|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
289279|NCT01274559|P2|Participant Flow|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
289280|NCT01274559|P1|Participant Flow|Extended-release Niacin/Laropiprant|Extended-release niacin (ERN)/laropiprant (LRPT) 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
289281|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
289282|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
289283|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
289284|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
289285|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
289286|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
289287|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
289288|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
289289|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
289290|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
289291|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
289292|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
289296|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
289297|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
289298|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
289299|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
289300|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
289301|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
289302|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
289303|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
289304|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
289305|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
289306|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
289307|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
289308|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
289309|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
289310|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
289311|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
289312|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
289313|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
289314|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
289315|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
289316|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
289317|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
289318|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
289319|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
289320|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
289321|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
289322|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
289323|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
289324|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
289325|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
289326|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
289327|NCT01274559|E2|Reported Event|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
289328|NCT01274559|E1|Reported Event|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
289329|NCT01274533|B1|Baseline|Lenalidomide|"Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.~Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle"
289330|NCT01274533|P1|Participant Flow|Lenalidomide|"Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.~Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle"
289331|NCT01274533|O1|Outcome|Lenalidomide|"Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.~Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle"
289332|NCT01274533|O1|Outcome|Lenalidomide|"Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.~Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle"
289333|NCT01274533|E1|Reported Event|Lenalidomide|"Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.~Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle"
289334|NCT01274429|B1|Baseline|Open Label Peanut Flour|"Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.~Peanut flour: Peanut flour that is ingested daily and administered in gradually increasing amounts up to a maximum maintenance dose."
289335|NCT01274429|P1|Participant Flow|Open Label Peanut Flour|Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.
289336|NCT01274429|O1|Outcome|Open Label Peanut Flour|Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.
289337|NCT01274429|O1|Outcome|Open Label Peanut Flour|Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.
289338|NCT01274429|E1|Reported Event|Open Label Peanut Flour|Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.
289339|NCT01274182|B4|Baseline|Total|Total of all reporting groups
289340|NCT01274182|B3|Baseline|Rituxan|Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289341|NCT01274182|B2|Baseline|MabThera|MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289342|NCT01274182|B1|Baseline|GP2013|GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289343|NCT01274182|P3|Participant Flow|Rituxan|Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289344|NCT01274182|P2|Participant Flow|MabThera|MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289345|NCT01274182|P1|Participant Flow|GP2013|GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289346|NCT01274182|O3|Outcome|Rituxan|Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289347|NCT01274182|O2|Outcome|MabThera|MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289348|NCT01274182|O1|Outcome|GP2013|GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289349|NCT01274182|O4|Outcome|MabThera|MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289350|NCT01274182|O3|Outcome|GP2013 Part I|"This is the subgroup of patients in the GP2013 treatment arm, who were enrolled in the study Part I.~Efficacy comparisons between GP2013 and MabThera were done in the study Part I on patients enrolled only in the study Part I"
289351|NCT01274182|O2|Outcome|Rituxan|Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289352|NCT01274182|O1|Outcome|GP2013|GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289353|NCT01274182|O4|Outcome|MabThera|MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289354|NCT01274182|O3|Outcome|GP2013 Part I|"This is the subgroup of patients in the GP2013 treatment arm, who were enrolled in the study Part I.~Efficacy comparisons between GP2013 and MabThera were done in the study Part I on patients enrolled only in the study Part I"
289355|NCT01274182|O2|Outcome|Rituxan|Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289356|NCT01274182|O1|Outcome|GP2013|GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289357|NCT01274182|O4|Outcome|MabThera|MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289358|NCT01274182|O3|Outcome|GP2013 Part I|"This is the subgroup of patients in the GP2013 treatment arm, who were enrolled in the study Part I.~Efficacy comparisons between GP2013 and MabThera were done in the study Part I on patients enrolled only in the study Part I"
289359|NCT01274182|O2|Outcome|Rituxan|Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289360|NCT01274182|O1|Outcome|GP2013|GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289361|NCT01274182|O4|Outcome|GP2013 Part I|"This is the subgroup of patients in the GP2013 treatment arm, who were enrolled in the study Part I.~Efficacy comparisons between GP2013 and MabThera were done in the study Part I on patients enrolled only in the study Part I"
289362|NCT01274182|O3|Outcome|Rituxan|Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289363|NCT01274182|O2|Outcome|MabThera|MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289364|NCT01274182|O1|Outcome|GP2013|GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289365|NCT01274182|O4|Outcome|GP2013 Part I|"This is the subgroup of patients in the GP2013 treatment arm, who were enrolled in the study Part I.~Efficacy comparisons between GP2013 and MabThera were done in the study Part I on patients enrolled only in the study Part I"
289366|NCT01274182|O3|Outcome|Rituxan|Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289367|NCT01274182|O2|Outcome|MabThera|MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289368|NCT01274182|O1|Outcome|GP2013|GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289369|NCT01274182|O3|Outcome|Rituxan|Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289370|NCT01274182|O2|Outcome|MabThera|MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289560|NCT01273038|B3|Baseline|Total|Total of all reporting groups
289371|NCT01274182|O1|Outcome|GP2013|GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289372|NCT01274182|O3|Outcome|Rituxan|Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289373|NCT01274182|O2|Outcome|MabThera|MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289374|NCT01274182|O1|Outcome|GP2013|GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289375|NCT01274182|O3|Outcome|Rituxan|Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289376|NCT01274182|O2|Outcome|MabThera|MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289377|NCT01274182|O1|Outcome|GP2013|GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289378|NCT01274182|E3|Reported Event|Rituxan|Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289379|NCT01274182|E2|Reported Event|MabThera|MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289380|NCT01274182|E1|Reported Event|GP2013|GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
289381|NCT01273896|B1|Baseline|STA-9090|"This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.~STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression."
289382|NCT01273896|P1|Participant Flow|STA-9090|"This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.~STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression."
289383|NCT01273896|O1|Outcome|STA-9090|"This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.~STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression."
289384|NCT01273896|E1|Reported Event|STA-9090|"This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.~STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression."
289385|NCT01273883|B1|Baseline|Entire Study Population|Includes groups randomized to receive magnesium first and placebo first.
289386|NCT01273883|P2|Participant Flow|Placebo First, Then Magnesium|Placebo daily for 25 days followed by 2 weeks of washout followed by magnesium 532 mg daily for 25 days.
289387|NCT01273883|P1|Participant Flow|Magnesium First, Then Placebo|Magnesium 532 mg daily for 25 days followed by 2 weeks of washout followed by 25 days of placebo.
289388|NCT01273883|O2|Outcome|Placebo|Placebo administered daily in either first intervention period or second intervention period.
289389|NCT01273883|O1|Outcome|Magnesium|Magnesium 532 mg administered daily in either first intervention period or second intervention period.
289390|NCT01273883|O2|Outcome|Placebo|Placebo administered daily in either first intervention period or second intervention period.
289391|NCT01273883|O1|Outcome|Magnesium|Magnesium 532 mg administered daily in either first intervention period or second intervention period.
289392|NCT01273883|O2|Outcome|Placebo|Placebo administered daily in either first intervention period or second intervention period.
289393|NCT01273883|O1|Outcome|Magnesium|Magnesium 532 mg administered daily in either first intervention period or second intervention period.
289394|NCT01273883|O2|Outcome|Placebo|Placebo administered daily in either first intervention period or second intervention period.
289395|NCT01273883|O1|Outcome|Magnesium|Magnesium 532 mg administered daily in either first intervention period or second intervention period.
289396|NCT01273883|E2|Reported Event|Placebo|Placebo administered daily in either first intervention period or second intervention period.
289397|NCT01273883|E1|Reported Event|Magnesium|Magnesium 532 mg administered daily in either first intervention period or second intervention period.
289398|NCT01273857|B3|Baseline|Total|Total of all reporting groups
289399|NCT01273857|B2|Baseline|Cell Infusion|"Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure~Autologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
289400|NCT01273857|B1|Baseline|Control|"Subjects will undergo standard staged-procedures without cell infusion~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
289401|NCT01273857|P2|Participant Flow|Cell Infusion|"Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure~Autologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
289402|NCT01273857|P1|Participant Flow|Control|"Subjects will undergo standard staged-procedures without cell infusion~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
289403|NCT01273857|O2|Outcome|Cell Infusion|"Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure~Autologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
326934|NCT01180777|O3|Outcome|Etafilcon A (C)|Daily wear contact lens
289404|NCT01273857|O1|Outcome|Control|"Subjects will undergo standard staged-procedures without cell infusion~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
289405|NCT01273857|O2|Outcome|Cell Infusion|"Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure~Autologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
289406|NCT01273857|O1|Outcome|Control|"Subjects will undergo standard staged-procedures without cell infusion~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
289407|NCT01273857|E2|Reported Event|Cell Infusion|"Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure~Autologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
289408|NCT01273857|E1|Reported Event|Control|"Subjects will undergo standard staged-procedures without cell infusion~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
289409|NCT01273818|B4|Baseline|Total|Total of all reporting groups
289410|NCT01273818|B3|Baseline|Gentamicin+ Cefazolin Sodium|Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively
289411|NCT01273818|B2|Baseline|Cephazolin|Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery
289412|NCT01273818|B1|Baseline|Gentamicin|Gentamicin arm: application of 80 mg gentamycin topically
289413|NCT01273818|P3|Participant Flow|Gentamicin+ Cefazolin Sodium|Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively
289414|NCT01273818|P2|Participant Flow|Cefazolin|Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery
289415|NCT01273818|P1|Participant Flow|Gentamicin|Gentamicin arm: application of 80 mg gentamycin topically
289416|NCT01273818|O3|Outcome|Topical and iv|Total number of patients to which topical gentamicin and cephazoline (iv) was applied for prophylaxis
289417|NCT01273818|O2|Outcome|Cefazolin IV|Total number of patients to which ceephazoline (İV) was applied for prophylaxis
289418|NCT01273818|O1|Outcome|Topical Gentamicin|Total number of patients to which topical gentamicin was applied for prophylaxis
289419|NCT01273818|E3|Reported Event|Gentamicin+ Cefazolin Sodium|"Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively~Gentamicins+cephazolin sodium: 80 mg topically, intra-operative,single dose~No adverse effect"
289420|NCT01273818|E2|Reported Event|Cephazolin|"Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery~Gentamicins+cephazolin sodium: 80 mg topically, intra-operative,single dose~No adverse effect"
289421|NCT01273818|E1|Reported Event|Gentamicin|"Gentamicin arm: application of 80 mg gentamycin topically~Gentamicins+cephazolin sodium: 80 mg topically, intra-operative,single dose~No adverse effect"
289422|NCT01273805|B3|Baseline|Total|Total of all reporting groups
289423|NCT01273805|B2|Baseline|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
289424|NCT01273805|B1|Baseline|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
289425|NCT01273805|P2|Participant Flow|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
289426|NCT01273805|P1|Participant Flow|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
289427|NCT01273805|O2|Outcome|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
289428|NCT01273805|O1|Outcome|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
289429|NCT01273805|O2|Outcome|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
289430|NCT01273805|O1|Outcome|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
289431|NCT01273805|O2|Outcome|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
289432|NCT01273805|O1|Outcome|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
326935|NCT01180777|O2|Outcome|Etafilcon A (B)|Daily wear contact lens
289433|NCT01273805|O2|Outcome|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
289434|NCT01273805|O1|Outcome|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
289435|NCT01273805|O2|Outcome|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
289436|NCT01273805|O1|Outcome|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
289437|NCT01273805|O2|Outcome|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
289438|NCT01273805|O1|Outcome|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
289439|NCT01273805|E2|Reported Event|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
289440|NCT01273805|E1|Reported Event|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
289441|NCT01273766|B4|Baseline|Total|Total of all reporting groups
289442|NCT01273766|B3|Baseline|Correlative|treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
289443|NCT01273766|B2|Baseline|Control Arm|blood tested on healthy patients
289444|NCT01273766|B1|Baseline|Arm I|"Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.~deferasirox : Given orally~laboratory biomarker analysis : Correlative studies~enzyme-linked immunosorbent assay : Correlative studies"
289445|NCT01273766|P3|Participant Flow|Correlative|treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
289446|NCT01273766|P2|Participant Flow|Control Arm|blood tested on healthy patients
289447|NCT01273766|P1|Participant Flow|Arm I|"Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.~deferasirox : Given orally~laboratory biomarker analysis : Correlative studies~enzyme-linked immunosorbent assay : Correlative studies"
289448|NCT01273766|O2|Outcome|Correlative|treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
289449|NCT01273766|O1|Outcome|Arm I|"Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.~deferasirox : Given orally~laboratory biomarker analysis : Correlative studies~enzyme-linked immunosorbent assay : Correlative studies"
289450|NCT01273766|O2|Outcome|Correlative|treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
289451|NCT01273766|O1|Outcome|Arm I|"Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.~deferasirox : Given orally~laboratory biomarker analysis : Correlative studies~enzyme-linked immunosorbent assay : Correlative studies"
289452|NCT01273766|O1|Outcome|Arm I|"Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.~deferasirox : Given orally~laboratory biomarker analysis : Correlative studies~enzyme-linked immunosorbent assay : Correlative studies"
289453|NCT01273766|E3|Reported Event|Correlative|treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
289454|NCT01273766|E2|Reported Event|Control Arm|blood tested on healthy patients
289455|NCT01273766|E1|Reported Event|Arm I|"Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.~deferasirox : Given orally~laboratory biomarker analysis : Correlative studies~enzyme-linked immunosorbent assay : Correlative studies"
289456|NCT01273623|B1|Baseline|Single Arm|subjects with calcified peripheral arterial lesions determined by intravascular ultrasound
289457|NCT01273623|P1|Participant Flow|Single Arm|subjects with calcified peripheral arterial lesions determined by intravascular ultrasound
289458|NCT01273623|O1|Outcome|Study Participants|
289459|NCT01273623|O1|Outcome|Study Participants|
289460|NCT01273623|O2|Outcome|Post-atherectomy|after Jetstream use and prior to adjunctive therapies
289461|NCT01273623|O1|Outcome|Pre-atherectomy|prior to Jetstream use
289462|NCT01273623|E1|Reported Event|Study Participants|
289463|NCT01273597|B1|Baseline|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
289464|NCT01273597|P1|Participant Flow|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
289465|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
289926|NCT01272284|B1|Baseline|Altis® SIS|Participants implanted with Altis® Single Incision Sling
289466|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
289467|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
289468|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
289469|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
289470|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
289471|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
289472|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
289473|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
289474|NCT01273597|E1|Reported Event|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
289475|NCT01273519|B4|Baseline|Total|Total of all reporting groups
289476|NCT01273519|B3|Baseline|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289477|NCT01273519|B2|Baseline|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289478|NCT01273519|B1|Baseline|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289479|NCT01273519|P3|Participant Flow|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289480|NCT01273519|P2|Participant Flow|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289481|NCT01273519|P1|Participant Flow|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289482|NCT01273519|O2|Outcome|RA, PsA, AS: Month 12|Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289483|NCT01273519|O1|Outcome|RA, PsA, AS: Baseline|Participants at Baseline with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289484|NCT01273519|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289485|NCT01273519|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289486|NCT01273519|O1|Outcome|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289487|NCT01273519|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289488|NCT01273519|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289489|NCT01273519|O1|Outcome|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289490|NCT01273519|O1|Outcome|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289491|NCT01273519|O1|Outcome|PsA, AS|Participants with psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289492|NCT01273519|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289493|NCT01273519|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289494|NCT01273519|O1|Outcome|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289495|NCT01273519|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289496|NCT01273519|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289497|NCT01273519|O1|Outcome|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289498|NCT01273519|O1|Outcome|RA, PsA, AS|Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289499|NCT01273519|O2|Outcome|RA, PsA, AS: Month 12|Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289500|NCT01273519|O1|Outcome|RA, PsA, AS: Baseline|Participants at Baseline with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289501|NCT01273519|O2|Outcome|RA, PsA, AS: Month 12|Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289502|NCT01273519|O1|Outcome|RA, PsA, AS: Baseline|Participants at Baseline with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289503|NCT01273519|O2|Outcome|RA, PsA, AS: Month 12|Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289504|NCT01273519|O1|Outcome|RA, PsA, AS: Baseline|Participants at Baseline with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289505|NCT01273519|O2|Outcome|RA, PsA, AS: Month 12|Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289506|NCT01273519|O1|Outcome|RA, PsA, AS: Baseline|Participants at Baseline with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289507|NCT01273519|O1|Outcome|RA, PsA, AS|Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289508|NCT01273519|O2|Outcome|RA, PsA, AS: Month 12|Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289509|NCT01273519|O1|Outcome|RA, PsA, AS: Baseline|Participants at Baseline with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289510|NCT01273519|O1|Outcome|RA, PsA, AS|Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289511|NCT01273519|O1|Outcome|RA, PsA, AS|Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289512|NCT01273519|E1|Reported Event|RA, PsA, AS|Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
289513|NCT01273181|B5|Baseline|Total|Total of all reporting groups
289514|NCT01273181|B4|Baseline|Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer|"Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
289515|NCT01273181|B3|Baseline|Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC|"Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
289561|NCT01273038|B2|Baseline|SenSura (Reference Filter)|The reference filter was the commercially available Sensura filter on the 1-piece colostomy bag.
289562|NCT01273038|B1|Baseline|Morfeus (Test Filter)|The new filter Morfeus is intended to clean the air and prevent ballooning in a 1-piece colostomy appliance.
289516|NCT01273181|B2|Baseline|Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
289517|NCT01273181|B1|Baseline|Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
289518|NCT01273181|P4|Participant Flow|Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer|anti-MAGE A3/12 TCR PBL MTD + HD IL-2 Other cancers
289519|NCT01273181|P3|Participant Flow|Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC|anti-MAGE A3/12 TCR PBL MTD + HD IL-2 Melanoma, RCC
289520|NCT01273181|P2|Participant Flow|Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
289521|NCT01273181|P1|Participant Flow|Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
289522|NCT01273181|O4|Outcome|Anti-MAGE TCR PBL +HD IL-2, Other|"anti-MAGE A3/12 TCR PBL MTD +HD-IL-1 Other cancers~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
289523|NCT01273181|O3|Outcome|Anti-MAGE TCR PBL+HD IL-2, Mel, RCC|"anti-MAGE A3/12 TCR PBL MTD + HD IL-2 Melanoma, RCC~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
289524|NCT01273181|O2|Outcome|Anti-MAGE TCR PBL 5x10e10 +HD IL-2|"anti-MAGE A3/12 TCR PBL 5x10e9 to 3 x 10e10 + HD IL-2~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
289525|NCT01273181|O1|Outcome|Anti-MAGE TCR PBL 5x10e9 +HD IL-2|"anti-MAGE A3/12 TCR PBL 3x10e10 to 1 x 10e11 + HD IL-2~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
289526|NCT01273181|O4|Outcome|Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer|"Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
289527|NCT01273181|O3|Outcome|Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC|"Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
289528|NCT01273181|O2|Outcome|Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
289529|NCT01273181|O1|Outcome|Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
289530|NCT01273181|E4|Reported Event|Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer|"Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
289531|NCT01273181|E3|Reported Event|Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC|"Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
289532|NCT01273181|E2|Reported Event|Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
289533|NCT01273181|E1|Reported Event|Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
289534|NCT01273064|B6|Baseline|Total|Total of all reporting groups
289563|NCT01273038|P2|Participant Flow|SenSura First (Reference Filter), Then Morfeus (Test Filter)|First Intervention with SenSura (14 days) then Second Intervention with Morfeus (14 days)
289564|NCT01273038|P1|Participant Flow|Morfeus First (Test Filter), Then SenSura (Reference Filter)|First Intervention with Morfeus (14 days) then Second Intervention with SenSura (14 days)
289535|NCT01273064|B5|Baseline|Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
289536|NCT01273064|B4|Baseline|Placebo + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
289537|NCT01273064|B3|Baseline|CTS-1027 15 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
289538|NCT01273064|B2|Baseline|CTS-1027 30 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
289539|NCT01273064|B1|Baseline|CTS-1027 60 mg + Ribavirin + Peglyated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
289540|NCT01273064|P5|Participant Flow|Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
289541|NCT01273064|P4|Participant Flow|Placebo + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
289542|NCT01273064|P3|Participant Flow|CTS-1027 15 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
289543|NCT01273064|P2|Participant Flow|CTS-1027 30 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
289544|NCT01273064|P1|Participant Flow|CTS-1027 60 mg + Ribavirin + Peglyated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
289545|NCT01273064|O5|Outcome|Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
289546|NCT01273064|O4|Outcome|Placebo + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
289547|NCT01273064|O3|Outcome|CTS-1027 15 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
289548|NCT01273064|O2|Outcome|CTS-1027 30 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
289549|NCT01273064|O1|Outcome|CTS-1027 60 mg + Ribavirin + Peglyated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
289550|NCT01273064|O5|Outcome|Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
289551|NCT01273064|O4|Outcome|Placebo + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
289552|NCT01273064|O3|Outcome|CTS-1027 15 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
289553|NCT01273064|O2|Outcome|CTS-1027 30 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
289554|NCT01273064|O1|Outcome|CTS-1027 60 mg + Ribavirin + Peglyated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
289555|NCT01273064|E5|Reported Event|Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
289556|NCT01273064|E4|Reported Event|Placebo + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
289557|NCT01273064|E3|Reported Event|CTS-1027 15 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
289558|NCT01273064|E2|Reported Event|CTS-1027 30 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
289559|NCT01273064|E1|Reported Event|CTS-1027 60 mg + Ribavirin + Peglyated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
289565|NCT01273038|O2|Outcome|SenSura (Reference Filter)|The reference filter was the commercially available Sensura filter on the 1-piece colostomy bag.
289566|NCT01273038|O1|Outcome|Morfeus (Test Filter)|The new filter Morfeus is intended to clean the air and prevent ballooning in a 1-piece colostomy appliance.
289567|NCT01273038|E2|Reported Event|SenSura (Reference Filter)|The reference filter was the commercially available Sensura filter on the 1-piece colostomy bag.
289568|NCT01273038|E1|Reported Event|Morfeus (Test Filter)|The new filter Morfeus is intended to clean the air and prevent ballooning in a 1-piece colostomy appliance.
289569|NCT01272960|B3|Baseline|Total|Total of all reporting groups
289570|NCT01272960|B2|Baseline|Post-Placental Mirena Insertion|15 received Mirena insertion within 10 minutes of delivery of placenta
289571|NCT01272960|B1|Baseline|Interval Insertion|14 subjects received Mirena at 4-8 weeks post-partum after vaginal delivery.
289572|NCT01272960|P2|Participant Flow|Post-Placental Mirena Insertion|"Will receive Mirena insertion within 10 minutes of delivery of placenta~Post-Placenta Mirena Insertion: Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta"
289573|NCT01272960|P1|Participant Flow|Interval Insertion|"Will receive Mirena at 4-8 weeks post-partum after vaginal delivery.~Post-Placenta Mirena Insertion: Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta"
289574|NCT01272960|O2|Outcome|Post-Placental Mirena Insertion|"Will receive Mirena insertion within 10 minutes of delivery of placenta~Post-Placenta Mirena Insertion: Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta"
289575|NCT01272960|O1|Outcome|Interval Insertion|"Will receive Mirena at 4-8 weeks post-partum after vaginal delivery.~Post-Placenta Mirena Insertion: Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta"
289576|NCT01272960|O2|Outcome|Post-Placental Mirena Insertion|"Will receive Mirena insertion within 10 minutes of delivery of placenta~Post-Placenta Mirena Insertion: Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta"
289577|NCT01272960|O1|Outcome|Interval Insertion|"Will receive Mirena at 4-8 weeks post-partum after vaginal delivery.~Interval Insertion: Insertion of Mirena 4-8 weeks post partum after vaginal delivery"
289578|NCT01272960|O2|Outcome|Post-Placental Mirena Insertion|"Will receive Mirena insertion within 10 minutes of delivery of placenta~Post-Placenta Mirena Insertion: Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta"
289579|NCT01272960|O1|Outcome|Interval Insertion|"Will receive Mirena at 4-8 weeks post-partum after vaginal delivery.~Post-Placenta Mirena Insertion: Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta"
289580|NCT01272960|O2|Outcome|Interval Insertion|
289581|NCT01272960|O1|Outcome|Post Placental Mirena Insertion|
289582|NCT01272960|E2|Reported Event|Post Placental Mirena Insertion|
289583|NCT01272960|E1|Reported Event|Interval Insertion|
289584|NCT01272947|B3|Baseline|Total|Total of all reporting groups
289585|NCT01272947|B2|Baseline|Placebo|
289586|NCT01272947|B1|Baseline|Diclofenac Sodium Topical Gel 1%|
289587|NCT01272947|P2|Participant Flow|Placebo|
289588|NCT01272947|P1|Participant Flow|Diclofenac Sodium Topical Gel 1%|
289589|NCT01272947|O2|Outcome|Placebo|
289590|NCT01272947|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
289591|NCT01272947|O2|Outcome|Placebo|
289592|NCT01272947|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
289593|NCT01272947|E2|Reported Event|Placebo|
289594|NCT01272947|E1|Reported Event|Diclofenac Sodium Topical Gel 1%|
289595|NCT01272934|B3|Baseline|Total|Total of all reporting groups
289596|NCT01272934|B2|Baseline|Placebo|Placebo : Topical gel-4 times daily
289597|NCT01272934|B1|Baseline|Diclofenac Sodium Topical Gel 1%|"Diclofenac sodium topical gel 1%~Diclofenac Sodium : Topical gel 1%-4 times daily"
289598|NCT01272934|P2|Participant Flow|Placebo|Placebo : Topical gel-4 times daily
289599|NCT01272934|P1|Participant Flow|Diclofenac Sodium Topical Gel 1%|"Diclofenac sodium topical gel 1%~Diclofenac Sodium : Topical gel 1%-4 times daily"
289600|NCT01272934|O2|Outcome|Placebo|
289601|NCT01272934|O1|Outcome|Diclofenac Sodium Topical Gel 1%|"Diclofenac sodium topical gel 1%~Diclofenac Sodium : Topical gel 1%-4 times daily"
289602|NCT01272934|O2|Outcome|Placebo|Placebo : Topical gel-4 times daily
289603|NCT01272934|O1|Outcome|Diclofenac Sodium Topical Gel 1%|"Diclofenac sodium topical gel 1%~Diclofenac Sodium : Topical gel 1%-4 times daily"
289604|NCT01272934|E2|Reported Event|Placebo|Placebo : Topical gel-4 times daily
289605|NCT01272934|E1|Reported Event|Diclofenac Sodium Topical Gel 1%|"Diclofenac sodium topical gel 1%~Diclofenac Sodium : Topical gel 1%-4 times daily"
289606|NCT01272921|B3|Baseline|Total|Total of all reporting groups
289607|NCT01272921|B2|Baseline|GROUP 2|"Varying does to determine duration of analgesia following a sciatic nerve block~Ropivacaine : Varying doses to determine the duration of analgesia"
289608|NCT01272921|B1|Baseline|GROUP 1|"Varying does to determine duration of analgesia following a sciatic nerve block~Bupivacaine : Varying doses to determine the duration of analgesia"
289609|NCT01272921|P2|Participant Flow|Ropivacaine|"Varying does to determine duration of analgesia following a sciatic nerve block~Ropivacaine : Varying doses to determine the duration of analgesia"
289610|NCT01272921|P1|Participant Flow|Bupivacaine|"Varying does to determine duration of analgesia following a sciatic nerve block~Bupivacaine : Varying doses to determine the duration of analgesia"
289611|NCT01272921|O2|Outcome|Ropivacaine|"Varying does to determine duration(motor/sensory)of analgesia following a sciatic nerve block~Ropivacaine : 2.5ml and 5.0mL (less than 10ml) and greater than or equal to 10ml (10-30ml)"
289612|NCT01272921|O1|Outcome|Bupivacaine|"Varying does to determine duration(motor/sensory)of analgesia following a sciatic nerve block~Bupivacaine : 2.5ml and 5.0mL (less than 10ml) and greater than or equal to 10ml (10-30ml)"
289613|NCT01272921|O2|Outcome|Below CIEL|The mean threshold current required to elicit a motor response below the common investing extraneural layer (CIEL).
289614|NCT01272921|O1|Outcome|Above CIEL|The mean threshold current required to elicit a motor response above the common investing extraneural layer (CIEL).
290794|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
289615|NCT01272921|E2|Reported Event|GROUP 2|"Varying does to determine duration(motor/sensory)of analgesia following a sciatic nerve block~Ropivacaine : 2.5ml and 5.0mL (less than 10ml) and greater than or equal to 10ml (10-30ml)"
289616|NCT01272921|E1|Reported Event|GROUP 1|"Varying does to determine duration(motor/sensory)of analgesia following a sciatic nerve block~Bupivacaine : 2.5ml and 5.0mL (less than 10ml) and greater than or equal to 10ml (10-30ml)"
289617|NCT01272908|B1|Baseline|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
289618|NCT01272908|P1|Participant Flow|Rituximab + Methotrexate (MTX)|Participants received rituximab 1000 milligrams (mg) intravenously (IV) and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg per week (mg/week) and a stable dose of folate (greater than or equal to [≥]5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (Disease Activity Score based on 28-Joint Count [DAS28] score of greater than or equal to [≥]2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg], given 14 days apart), at any time between Week 24 and 48.
289619|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
289620|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
289621|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
289622|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
289623|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
289624|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
289625|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
289626|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
289627|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
289661|NCT01272869|O1|Outcome|Sensura|SenSura is the reference product and the product is already commercially available
289628|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
289629|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
289630|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
289631|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
289632|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
289633|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
289634|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
289635|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
289636|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
289637|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
289638|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
289639|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
289640|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
289662|NCT01272869|E2|Reported Event|Morfeus|The test product is the product with the proposed new filter (Morfeus)
289663|NCT01272869|E1|Reported Event|Sensura|The reference product is the SenSura product which is already commercially available
289664|NCT01272830|B3|Baseline|Total|Total of all reporting groups
289665|NCT01272830|B2|Baseline|Placebo|"Oral capsule of similar appearance and taste without Apatone®B~Placebo: Two capsules taken twice daily with meals"
289641|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
289642|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
289643|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
289644|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
289645|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
289646|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
289647|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
289648|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
289649|NCT01272908|E2|Reported Event|Re-treatment: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
289650|NCT01272908|E1|Reported Event|Initial Treatment: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
289651|NCT01272882|B1|Baseline|Adults With ARDS or ALI|"Adults with PaO2/FiO2 ratio less than 300.~Electrical Impedance Tomography monitoring : Chest belt with 16 electrodes connected to the EIT device"
289652|NCT01272882|P1|Participant Flow|Adults With ARDS or ALI|"Adults with PaO2/FiO2 ratio less than 300.~Electrical Impedance Tomography monitoring : Chest belt with 16 electrodes connected to the EIT device"
289653|NCT01272882|O1|Outcome|Adults With ARDS or ALI|Adults with PaO2/FiO2 ratio less than 300. Electrical Impedance Tomography monitoring : Chest belt with 16 electrodes connected to the EIT device
289654|NCT01272882|E1|Reported Event|Adults With ARDS or ALI|"Adults with PaO2/FiO2 ratio less than 300.~Electrical Impedance Tomography monitoring : Chest belt with 16 electrodes connected to the EIT device"
289655|NCT01272869|B3|Baseline|Total|Total of all reporting groups
289656|NCT01272869|B2|Baseline|Morfeus|The test product is the product with the proposed new filter (Morfeus)
289657|NCT01272869|B1|Baseline|Sensura|The reference product is the SenSura product which is already commercially available
289658|NCT01272869|P2|Participant Flow|Morfeus First; Then Sensura|The test product with the Morfeus filter is the test product with the proposed new filter.
289659|NCT01272869|P1|Participant Flow|Sensura First; Then Morfeus|The reference product is the SenSura product which is already commercially available
289660|NCT01272869|O2|Outcome|Morfeus|The test product is the product with the proposed new filter (Morfeus)
289914|NCT01272583|O3|Outcome|Placebo|
289666|NCT01272830|B1|Baseline|Oral Apatone®B|"An amalgam of Vitamins C & K3~Apatone®B: Two capsules taken twice daily with meals"
289667|NCT01272830|P2|Participant Flow|Placebo|"Oral capsule of similar appearance and taste without Apatone®B~Placebo: Two capsules taken twice daily with meals"
289668|NCT01272830|P1|Participant Flow|Oral Apatone®B|"An amalgam of Vitamins C & K3~Apatone®B: Two capsules taken twice daily with meals"
289669|NCT01272830|O2|Outcome|Placebo|"Oral capsule of similar appearance and taste without Apatone®B~Placebo: Two capsules taken twice daily with meals"
289670|NCT01272830|O1|Outcome|Oral Apatone®B|"An amalgam of Vitamins C & K3~Apatone®B: Two capsules taken twice daily with meals"
289671|NCT01272830|O2|Outcome|Placebo|"Oral capsule of similar appearance and taste without Apatone®B~Placebo: Two capsules taken twice daily with meals"
289672|NCT01272830|O1|Outcome|Oral Apatone®B|"An amalgam of Vitamins C & K3~Apatone®B: Two capsules taken twice daily with meals"
289673|NCT01272830|O2|Outcome|Placebo|"Oral capsule of similar appearance and taste without Apatone®B~Placebo: Two capsules taken twice daily with meals"
289674|NCT01272830|O1|Outcome|Oral Apatone®B|"An amalgam of Vitamins C & K3~Apatone®B: Two capsules taken twice daily with meals"
289675|NCT01272830|O2|Outcome|Placebo|"Oral capsule of similar appearance and taste without Apatone®B~Placebo: Two capsules taken twice daily with meals"
289676|NCT01272830|O1|Outcome|Oral Apatone®B|"An amalgam of Vitamins C & K3~Apatone®B: Two capsules taken twice daily with meals"
289677|NCT01272830|E2|Reported Event|Placebo|"Oral capsule of similar appearance and taste without Apatone®B~Placebo: Two capsules taken twice daily with meals"
289678|NCT01272830|E1|Reported Event|Oral Apatone®B|"An amalgam of Vitamins C & K3~Apatone®B: Two capsules taken twice daily with meals"
289679|NCT01272804|B7|Baseline|Total|Total of all reporting groups
289680|NCT01272804|B6|Baseline|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
289681|NCT01272804|B5|Baseline|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289682|NCT01272804|B4|Baseline|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289683|NCT01272804|B3|Baseline|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289684|NCT01272804|B2|Baseline|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289685|NCT01272804|B1|Baseline|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289686|NCT01272804|P6|Participant Flow|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
289687|NCT01272804|P5|Participant Flow|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289688|NCT01272804|P4|Participant Flow|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289689|NCT01272804|P3|Participant Flow|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289690|NCT01272804|P2|Participant Flow|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289691|NCT01272804|P1|Participant Flow|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289692|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
289693|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289694|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289695|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289696|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289697|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289698|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
289699|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289700|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289701|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289702|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289703|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289704|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
289705|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289706|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289707|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289708|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289709|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289710|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
289711|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289712|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289713|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289714|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289715|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289716|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
289717|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289718|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289719|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289720|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289721|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289722|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
289723|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289724|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289725|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289726|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289727|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289728|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
289729|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289730|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289731|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289732|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289733|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289734|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
289735|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289736|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289737|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289738|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289739|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289740|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
289741|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289742|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289743|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289744|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289745|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289746|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
289747|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289748|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289749|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289750|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289751|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289752|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
289753|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289754|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289755|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289756|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289757|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289758|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289759|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289760|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289761|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289762|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289763|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289764|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289765|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289766|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289767|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289768|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289769|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289770|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289771|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289772|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289773|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289774|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289775|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289776|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289777|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289778|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289779|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289780|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289781|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289782|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289783|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289784|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289785|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289786|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289787|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289788|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289789|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289790|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289791|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289792|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289793|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289794|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289795|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289796|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289797|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289798|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289799|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289800|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289801|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289802|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289803|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289804|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289805|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289806|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289807|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289808|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289809|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289810|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289811|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289915|NCT01272583|O2|Outcome|Sitagliptin Treatment|
289812|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289813|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289814|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289815|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289816|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289817|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289818|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289819|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289820|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289821|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289822|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289823|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289824|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289825|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289826|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289827|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289828|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289829|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289830|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289831|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289832|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289833|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
289834|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289835|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289836|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289837|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289838|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289839|NCT01272804|E6|Reported Event|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
289840|NCT01272804|E5|Reported Event|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
289841|NCT01272804|E4|Reported Event|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
289842|NCT01272804|E3|Reported Event|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
289843|NCT01272804|E2|Reported Event|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
289844|NCT01272804|E1|Reported Event|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
289845|NCT01272661|B4|Baseline|Total|Total of all reporting groups
289846|NCT01272661|B3|Baseline|Enhanced Curriculum+Father Support|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
289847|NCT01272661|B2|Baseline|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
289848|NCT01272661|B1|Baseline|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
289849|NCT01272661|P3|Participant Flow|Enhanced Curriculum +Father Support|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
289850|NCT01272661|P2|Participant Flow|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
289851|NCT01272661|P1|Participant Flow|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
289852|NCT01272661|O3|Outcome|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
289853|NCT01272661|O2|Outcome|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
289854|NCT01272661|O1|Outcome|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
289855|NCT01272661|O3|Outcome|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
289856|NCT01272661|O2|Outcome|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
289857|NCT01272661|O1|Outcome|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
289858|NCT01272661|O3|Outcome|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
289859|NCT01272661|O2|Outcome|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
289860|NCT01272661|O1|Outcome|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
289861|NCT01272661|O3|Outcome|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
289862|NCT01272661|O2|Outcome|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
289863|NCT01272661|O1|Outcome|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
289864|NCT01272661|O3|Outcome|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
289865|NCT01272661|O2|Outcome|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
289866|NCT01272661|O1|Outcome|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
289867|NCT01272661|O3|Outcome|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
289916|NCT01272583|O1|Outcome|Baseline|
289917|NCT01272583|O3|Outcome|Placebo|
289918|NCT01272583|O2|Outcome|Sitagliptin Treatment|
289919|NCT01272583|O1|Outcome|Baseline|
289920|NCT01272583|O3|Outcome|Placebo|
289868|NCT01272661|O2|Outcome|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
289869|NCT01272661|O1|Outcome|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
289870|NCT01272661|E3|Reported Event|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
289871|NCT01272661|E2|Reported Event|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
289872|NCT01272661|E1|Reported Event|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
289873|NCT01272635|B3|Baseline|Total|Total of all reporting groups
289874|NCT01272635|B2|Baseline|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
289875|NCT01272635|B1|Baseline|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
289876|NCT01272635|P4|Participant Flow|Placebo/Placebo|"Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day~Placebo Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day"
289877|NCT01272635|P3|Participant Flow|Placebo/Prednisolone|"Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day~Active Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day"
289878|NCT01272635|P2|Participant Flow|Azithromycin/Placebo|"Active Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day~Placebo Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day"
289879|NCT01272635|P1|Participant Flow|Azithromycin/Prednisolone|"Active Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day~Active Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day"
289880|NCT01272635|O2|Outcome|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
289881|NCT01272635|O1|Outcome|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
289882|NCT01272635|O2|Outcome|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
289883|NCT01272635|O1|Outcome|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
289884|NCT01272635|O2|Outcome|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
289885|NCT01272635|O1|Outcome|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
289886|NCT01272635|O2|Outcome|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
289887|NCT01272635|O1|Outcome|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
289888|NCT01272635|O2|Outcome|Placebo|Placebo Prednisone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day
289889|NCT01272635|O1|Outcome|Prednisone|Active Prednisone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day
289890|NCT01272635|O2|Outcome|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
289891|NCT01272635|O1|Outcome|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
289892|NCT01272635|E2|Reported Event|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
289893|NCT01272635|E1|Reported Event|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
289894|NCT01272583|B3|Baseline|Total|Total of all reporting groups
289895|NCT01272583|B2|Baseline|Sequence B (Placebo→Sitagliptin)|"Cross-over, both arms reveived the same intervention in different order.~Sitagliptin : 100 mg once daily for six weeks~Placebo : placebo, once daily for six weeks"
289896|NCT01272583|B1|Baseline|Sequence A (Sitagliptin→Placebo)|"Cross-over, both arms reveived the same intervention in different order.~Sitagliptin : 100 mg once daily for six weeks~Placebo : placebo, once daily for six weeks"
289897|NCT01272583|P2|Participant Flow|Sequence B (Placebo→Sitagliptin)|"Cross-over, both arms reveived the same intervention in different order.~Sitagliptin : 100 mg once daily for six weeks~Placebo : placebo, once daily for six weeks"
289898|NCT01272583|P1|Participant Flow|Sequence A (Sitagliptin→Placebo)|"Cross-over, both arms reveived the same intervention in different order.~Sitagliptin : 100 mg once daily for six weeks~Placebo : placebo, once daily for six weeks"
289899|NCT01272583|O3|Outcome|Placebo|
289900|NCT01272583|O2|Outcome|Sitagliptin Treatment|
289901|NCT01272583|O1|Outcome|Baseline|
289902|NCT01272583|O3|Outcome|Placebo|
289903|NCT01272583|O2|Outcome|Sitagliptin Treatment|
289904|NCT01272583|O1|Outcome|Baseline|
289905|NCT01272583|O3|Outcome|Placebo|
289906|NCT01272583|O2|Outcome|Sitagliptin Treatment|
289907|NCT01272583|O1|Outcome|Baseline|
289908|NCT01272583|O3|Outcome|Placebo|
289909|NCT01272583|O2|Outcome|Sitagliptin Treatment|
289910|NCT01272583|O1|Outcome|Baseline|
289911|NCT01272583|O3|Outcome|Placebo|
289912|NCT01272583|O2|Outcome|Sitagliptin Treatment|
289913|NCT01272583|O1|Outcome|Baseline|
289927|NCT01272284|P1|Participant Flow|Altis® SIS|Participants implanted with Altis® Single Incision Sling
289928|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
289929|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
289930|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
289931|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
289932|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
289933|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
289934|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
289935|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
289936|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
289937|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
289938|NCT01272284|O1|Outcome|Altis SIS®|Participants implanted with Altis® Single Incision Sling
289939|NCT01272284|E1|Reported Event|Altis® SIS|Participants implanted with Altis® Single Incision Sling
289940|NCT01272245|B1|Baseline|Omacetaxine and Cytarabine|Omacetaxine 1.25 mg/m2 subcutaneously (SQ) every 12 hours for 3 days + Cytarabine 20 mg SQ for 7 days of 4-7 week cycle.
289941|NCT01272245|P1|Participant Flow|Omacetaxine and Cytarabine|Omacetaxine 1.25 mg/m2 subcutaneously (SQ) every 12 hours for 3 days + Cytarabine 20 mg SQ for 7 days of 4-7 week cycle.
289942|NCT01272245|O1|Outcome|Omacetaxine and Cytarabine|Omacetaxine 1.25 mg/m2 subcutaneously (SQ) every 12 hours for 3 days + Cytarabine 20 mg SQ for 7 days of 4-7 week cycle.
289943|NCT01272245|O1|Outcome|Omacetaxine and Cytarabine|Omacetaxine 1.25 mg/m2 subcutaneously (SQ) every 12 hours for 3 days + Cytarabine 20 mg SQ for 7 days of 4-7 week cycle.
289944|NCT01272245|O1|Outcome|Omacetaxine and Cytarabine|Omacetaxine 1.25 mg/m2 subcutaneously (SQ) every 12 hours for 3 days + Cytarabine 20 mg SQ for 7 days of 4-7 week cycle.
289945|NCT01272245|O1|Outcome|Omacetaxine and Cytarabine|Omacetaxine 1.25 mg/m2 subcutaneously (SQ) every 12 hours for 3 days + Cytarabine 20 mg SQ for 7 days of 4-7 week cycle.
289946|NCT01272245|O1|Outcome|Omacetaxine and Cytarabine|Omacetaxine 1.25 mg/m2 subcutaneously (SQ) every 12 hours for 3 days + Cytarabine 20 mg SQ for 7 days of 4-7 week cycle.
289947|NCT01272245|E1|Reported Event|Omacetaxine and Cytarabine|Omacetaxine 1.25 mg/m2 subcutaneously (SQ) every 12 hours for 3 days + Cytarabine 20 mg SQ for 7 days of 4-7 week cycle.
289948|NCT01272232|B4|Baseline|Total|Total of all reporting groups
289949|NCT01272232|B3|Baseline|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289950|NCT01272232|B2|Baseline|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289951|NCT01272232|B1|Baseline|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289952|NCT01272232|P3|Participant Flow|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289953|NCT01272232|P2|Participant Flow|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289954|NCT01272232|P1|Participant Flow|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289955|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289996|NCT01272219|B3|Baseline|Liraglutide 3.0 mg, Pre-diabetes|Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
289956|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289957|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289958|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289959|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289960|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289961|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289962|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289963|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289964|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289965|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289966|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289967|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289968|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
290063|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
289969|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289970|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289971|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289972|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289973|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289974|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289975|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289976|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289977|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289978|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289979|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289980|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289981|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
290064|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
289982|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289983|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289984|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289985|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289986|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289987|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289988|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289989|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289990|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289991|NCT01272232|E3|Reported Event|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289992|NCT01272232|E2|Reported Event|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289993|NCT01272232|E1|Reported Event|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
289994|NCT01272219|B5|Baseline|Total|Total of all reporting groups
289995|NCT01272219|B4|Baseline|Liraglutide Placebo, Pre-diabetes|Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
290065|NCT01272180|O4|Outcome|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
326936|NCT01180777|O1|Outcome|Etafilcon A (A)|Daily wear contact lens
289997|NCT01272219|B2|Baseline|Liraglutide Placebo, no Pre-diabetes|Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
289998|NCT01272219|B1|Baseline|Liraglutide 3.0 mg, no Pre-diabetes|Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
289999|NCT01272219|P6|Participant Flow|Liraglutide Placebo, Pre-diabetes|Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
290000|NCT01272219|P5|Participant Flow|Liraglutide 3.0 mg, Pre-diabetes|Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
290001|NCT01272219|P4|Participant Flow|Liraglutide Placebo, no Pre-diabetes|Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
290002|NCT01272219|P3|Participant Flow|Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)|Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
290003|NCT01272219|P2|Participant Flow|Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)|Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
290004|NCT01272219|P1|Participant Flow|Liraglutide 3.0 mg, no Pre-diabetes|Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
290005|NCT01272219|O3|Outcome|Liraglutide Placebo, no Pre-diabetes|Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
290006|NCT01272219|O2|Outcome|Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)|Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
290007|NCT01272219|O1|Outcome|Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)|Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
290008|NCT01272219|O3|Outcome|Liraglutide Placebo, no Pre-diabetes|Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
290009|NCT01272219|O2|Outcome|Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)|Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
290010|NCT01272219|O1|Outcome|Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)|Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
290011|NCT01272219|O2|Outcome|Liraglutide Placebo (160-Week)|Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
290012|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (160-Week)|Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
290013|NCT01272219|O2|Outcome|Liraglutide Placebo (160-Week)|Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
290014|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (160-Week)|Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
290066|NCT01272180|O3|Outcome|rMenB+OMV|Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
290015|NCT01272219|O2|Outcome|Liraglutide Placebo (160-Week)|Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
290016|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (160-Week)|Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
290017|NCT01272219|O2|Outcome|Liraglutide Placebo (56-Week)|Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
290018|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (56-Week)|Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
290019|NCT01272219|O2|Outcome|Liraglutide Placebo (160-Week)|Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
290020|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (160-Week)|Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
290021|NCT01272219|O2|Outcome|Liraglutide Placebo (56-Week)|Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
290022|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (56-Week)|Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
290023|NCT01272219|O2|Outcome|Liraglutide Placebo (160-Week)|Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
290024|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (160-Week)|Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
290025|NCT01272219|O2|Outcome|Liraglutide Placebo (56-Week)|Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
290026|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (56-Week)|Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
290027|NCT01272219|O2|Outcome|Liraglutide Placebo (56-Week)|Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
290028|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (56-Week)|Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
290029|NCT01272219|O2|Outcome|Liraglutide Placebo (56-Week)|Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
290030|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (56-Week)|Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
290031|NCT01272219|E4|Reported Event|Liraglutide Placebo, no Pre-diabetes|Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
290032|NCT01272219|E3|Reported Event|Liraglutide 3.0 mg, no Pre-diabetes|Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
290033|NCT01272219|E2|Reported Event|Liraglutide Placebo, Pre-diabetes|Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
290034|NCT01272219|E1|Reported Event|Liraglutide 3.0 mg, Pre-diabetes|Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
290035|NCT01272193|B3|Baseline|Total|Total of all reporting groups
290036|NCT01272193|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
290037|NCT01272193|B1|Baseline|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
290067|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
290068|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
290038|NCT01272193|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
290039|NCT01272193|P1|Participant Flow|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
290040|NCT01272193|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
290041|NCT01272193|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
290042|NCT01272193|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
290043|NCT01272193|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
290044|NCT01272193|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
290045|NCT01272193|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
290046|NCT01272193|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
290047|NCT01272193|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
290048|NCT01272193|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
290049|NCT01272193|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
290050|NCT01272193|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
290051|NCT01272193|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
290052|NCT01272193|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
290053|NCT01272193|E1|Reported Event|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
290054|NCT01272180|B5|Baseline|Total|Total of all reporting groups
290055|NCT01272180|B4|Baseline|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
290056|NCT01272180|B3|Baseline|rMenB +OMV|Subjects in this group received two doses of rMenB + OMV vaccine,administered two months apart.
290057|NCT01272180|B2|Baseline|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
290058|NCT01272180|B1|Baseline|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
290059|NCT01272180|P4|Participant Flow|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
290060|NCT01272180|P3|Participant Flow|rMenB +OMV|Subjects in this group received two doses of rMenB + OMV vaccine,administered two months apart.
290061|NCT01272180|P2|Participant Flow|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
290062|NCT01272180|P1|Participant Flow|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
290795|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
290069|NCT01272180|O4|Outcome|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
290070|NCT01272180|O3|Outcome|rMenB+OMV|Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
290071|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
290072|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
290073|NCT01272180|O3|Outcome|rMenB+OMV|Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
290074|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
290075|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
290076|NCT01272180|O3|Outcome|rMenB +OMV|Subjects in this group received two doses of rMenB + OMV vaccine, administered two months apart.
290077|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
290078|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
290079|NCT01272180|O3|Outcome|rMenB+OMV|Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
290080|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
290081|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
290082|NCT01272180|O3|Outcome|rMenB +OMV|Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
290083|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
290084|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
290085|NCT01272180|O3|Outcome|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
290086|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
290087|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
290088|NCT01272180|O3|Outcome|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
290089|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
290090|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
290091|NCT01272180|O3|Outcome|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
290092|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
290093|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
290094|NCT01272180|E4|Reported Event|ACWY|Subjects in this group received first dose of placebo followed by one dose of MenACWY vaccine administered two months apart.
290095|NCT01272180|E3|Reported Event|rMenB +OMV|Subjects in this group received two doses of rMenB + OMV vaccine, administered two months apart.
290096|NCT01272180|E2|Reported Event|ABCWY+qOMV|"Subjects in this group received two doses of rMenB (+ OMV_1/4th dose)~+and MenACWY combination vaccine, administered two months apart."
290097|NCT01272180|E1|Reported Event|ABCWY+OMV|Subjects in this group received two doses of rMenB(+ OMV_full dose) and MenACWY combination vaccine, administered two months apart.
290098|NCT01272141|B1|Baseline|Arm A: Lapatinib Plus Everolimus|"Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily~Everolimus: 5mg by mouth daily"
290099|NCT01272141|P1|Participant Flow|Arm A: Lapatinib Plus Everolimus|"Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily~Everolimus: 5mg by mouth daily"
290100|NCT01272141|O1|Outcome|Arm A: Lapatinib Plus Everolimus|"Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily~Everolimus: 5mg by mouth daily"
290101|NCT01272141|O1|Outcome|Arm A: Lapatinib Plus Everolimus|"Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily~Everolimus: 5mg by mouth daily"
290102|NCT01272141|E1|Reported Event|Arm A: Lapatinib Plus Everolimus|"Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily~Everolimus: 5mg by mouth daily"
290103|NCT01272076|B1|Baseline|GA Group|Patients diagnosed with dry AMD and geographic atrophy
290104|NCT01272076|P1|Participant Flow|Dry AMD With Geographic Atrophy|Patients diagnosed with dry AMD and geographic atrophy
290105|NCT01272076|O1|Outcome|GA Group|Inter-device variability in measuring the area of Geographic Atrophy. 3 acceptable scans from 3 Cirrus HD-OCT devices (total of 9) were taken by one operator in this phase.
290106|NCT01272076|E1|Reported Event|GA Group|Patients with dry age related macular degeneration and geographic atrophy.
290107|NCT01272011|B4|Baseline|Total|Total of all reporting groups
290108|NCT01272011|B3|Baseline|Phase 3 Arm (Ventilatory Loading)|This group of subjects was exposed to intermittent hypoxia and ventilatory loading was assessed.
290109|NCT01272011|B2|Baseline|Phase 2 Arm (Long Term Facilitation)|This group of subjects were exposed to intermittent hypoxia and minute ventilation was recorded to determine whether ventilatory long term facilitation (LTF) was present.
290110|NCT01272011|B1|Baseline|Phase 1 Arm (Pilot)|This group of participants were exposed to intermittent hypoxia and/or locomotor training. They were enrolled only to establish and streamline the protocol and train the laboratory personnel.
290111|NCT01272011|P3|Participant Flow|Phase 3 Arm (Ventilatory Loading)|This group of subjects was exposed to intermittent hypoxia and ventilatory loading was assessed.
290112|NCT01272011|P2|Participant Flow|Phase 2 Arm (LTF)|This group of subjects were exposed to intermittent hypoxia and minute ventilation was recorded to determine whether ventilatory long term facilitation (LTF) was present.
290398|NCT01271686|B1|Baseline|0.01% Bimatoprost|0.01% bimatoprost: 0.01% bimatoprost once in the evening for 4 weeks
290113|NCT01272011|P1|Participant Flow|Phase 1 Arm (Pilot)|This group of participants were exposed to intermittent hypoxia and/or locomotor training. They were enrolled only to establish and streamline the protocol and train the laboratory personnel.
290114|NCT01272011|O3|Outcome|Phase 3 Arm (Ventilatory Loading)|"Individuals were exposed to 10 days of intermittent hypoxia to determine changes in ventilatory loading.~Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days."
290115|NCT01272011|O2|Outcome|Phase 2 Arm (LTF)|"Individuals were exposed to 10 days of intermittent hypoxia to determine the effect of this intervention on ventilatory long-term facilitation, as measured by minute ventilation.~Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days."
290116|NCT01272011|O1|Outcome|Phase 1 Arm (Pilot)|"Individuals were exposed to intermittent hypoxia and locomotor training to establish our interventions (set up lab, train personnel, develop study protocols/interventions, etc)~Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days.~Locomotor Training: Individuals received 10 days of locomotor training, intense walking training on a treadmill with body weight support. Manual assistance was provided at the legs to optimize stepping patterns."
290117|NCT01272011|O3|Outcome|Phase 3 Arm (Ventilatory Loading)|"Individuals were exposed to 10 days of intermittent hypoxia to determine changes in ventilatory loading.~Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days."
290118|NCT01272011|O2|Outcome|Phase 2 Arm (LTF)|"Individuals were exposed to 10 days of intermittent hypoxia to determine the effect of this intervention on ventilatory long-term facilitation, as measured by minute ventilation.~Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days."
290119|NCT01272011|O1|Outcome|Phase 1 Arm (Pilot)|"Individuals were exposed to intermittent hypoxia and locomotor training to establish our interventions (set up lab, train personnel, develop study protocols/interventions, etc)~Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days.~Locomotor Training: Individuals received 10 days of locomotor training, intense walking training on a treadmill with body weight support. Manual assistance was provided at the legs to optimize stepping patterns."
290120|NCT01272011|E3|Reported Event|Phase 3 Arm (Ventilatory Loading)|This group of subjects was exposed to intermittent hypoxia and ventilatory loading was assessed.
290121|NCT01272011|E2|Reported Event|Phase 2 Arm (Long Term Facilitation)|This group of subjects were exposed to intermittent hypoxia and minute ventilation was recorded to determine whether ventilatory long term facilitation (LTF) was present.
290122|NCT01272011|E1|Reported Event|Phase 1 Arm (Pilot)|This group of participants were exposed to intermittent hypoxia and/or locomotor training. They were enrolled only to establish and streamline the protocol and train the laboratory personnel.
290123|NCT01271946|B3|Baseline|Total|Total of all reporting groups
290124|NCT01271946|B2|Baseline|Sheath Greater Than 6F|
290125|NCT01271946|B1|Baseline|Intent to Treat|
290126|NCT01271946|P2|Participant Flow|Sheath Greater Than 6 French (F)|Subjects in whom the procedural sheath was upsized to greater than 6F.
290127|NCT01271946|P1|Participant Flow|Intent to Treat (ITT)|The ITT cohort consists of those subjects where an attempt was made to place the Arstasis device into subject's vasculature regardless of whether or not this attempt was successful.
290128|NCT01271946|O1|Outcome|Per Protocol|Time to Ambulation was evaluated in subjects in whom successful access with the Arstasis device was achieved and data was available.
290129|NCT01271946|O1|Outcome|Per Protocol|Time to Hemostasis was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
290130|NCT01271946|O2|Outcome|Sheath Greater Than 6F|Time to Bed Elevation was evaluated in subjects in whom successful access with the Arstasis device was achieved and data was available.
290131|NCT01271946|O1|Outcome|Intent to Treat|Time to Bed Elevation was evaluated in subjects in whom successful access with the Arstasis device was achieved and data was available.
290132|NCT01271946|O2|Outcome|Sheath Greater Than 6F|Time to Ambulation was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
290133|NCT01271946|O1|Outcome|Intent to Treat|Time to Ambulation was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
290134|NCT01271946|O2|Outcome|Sheath Greater Than 6F|
290135|NCT01271946|O1|Outcome|Intent to Treat|Time to Actual Discharge was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
290136|NCT01271946|O2|Outcome|Sheath Greater Than 6F|
290137|NCT01271946|O1|Outcome|Group 1|Time to Discharge Eligibility was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
290138|NCT01271946|O2|Outcome|Sheath Greater Than 6F|Time to Hemostasis was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
290139|NCT01271946|O1|Outcome|Intent to Treat|Time to Hemostasis was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
290140|NCT01271946|O2|Outcome|Sheath Greater Than 6F|Minor access site-related complications observed in subjects who were upsized to sheath size greater than 6F.
290141|NCT01271946|O1|Outcome|Group 1|Minor access site-related complications observed in the intent-to-treat population.
290142|NCT01271946|O2|Outcome|Sheath Greater Than 6F|
290143|NCT01271946|O1|Outcome|Intent to Treat|
290144|NCT01271946|O2|Outcome|Sheath Greater Than 6F|Major access site-related complications observed in subjects treated with sheath size greater than 6F.
290145|NCT01271946|O1|Outcome|Intent to Treat|Major access site-related complications observed in the intent-to-treat population.
290146|NCT01271946|E2|Reported Event|Sheath Greater Than 6F|
290147|NCT01271946|E1|Reported Event|Intent to Treat|
290148|NCT01271907|B4|Baseline|Total|Total of all reporting groups
290149|NCT01271907|B3|Baseline|Cohort 2|"1 Experimental Lymphodepleting regimen +Cells~3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells"
290796|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
290150|NCT01271907|B2|Baseline|Cohort 1|"2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2~2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
290151|NCT01271907|B1|Baseline|Cohort 0|"Drosophila generated CTL + SQ IL-2~1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
290152|NCT01271907|P3|Participant Flow|Cohort 2|"1 Experimental Lymphodepleting regimen +Cells~3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells"
290153|NCT01271907|P2|Participant Flow|Cohort 1|"2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2~2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
290154|NCT01271907|P1|Participant Flow|Cohort 0|"Drosophila generated CTL + SQ IL-2~1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
290155|NCT01271907|O3|Outcome|Cohort 2|"1 Experimental Lymphodepleting regimen +Cells~3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells"
290156|NCT01271907|O2|Outcome|Cohort 1|"2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2~2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
290157|NCT01271907|O1|Outcome|Cohort 0|"Drosophila generated CTL + SQ IL-2~1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
290158|NCT01271907|O3|Outcome|Cohort 2|"1 Experimental Lymphodepleting regimen +Cells~3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells"
290159|NCT01271907|O2|Outcome|Cohort 1|"2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2~2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
290160|NCT01271907|O1|Outcome|Cohort 0|"Drosophila generated CTL + SQ IL-2~1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
290161|NCT01271907|O3|Outcome|Cohort 2|"1 Experimental Lymphodepleting regimen +Cells~3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells"
290162|NCT01271907|O2|Outcome|Cohort 1|"2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2~2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
290163|NCT01271907|O1|Outcome|Cohort 0|"Drosophila generated CTL + SQ IL-2~1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
290164|NCT01271907|E3|Reported Event|Cohort 2|"1 Experimental Lymphodepleting regimen +Cells~3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells"
290165|NCT01271907|E2|Reported Event|Cohort 1|"2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2~2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
290166|NCT01271907|E1|Reported Event|Cohort 0|"Drosophila generated CTL + SQ IL-2~1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
290167|NCT01271855|B3|Baseline|Total|Total of all reporting groups
290168|NCT01271855|B2|Baseline|Belladonna and Opioid Suppository|Women assigned to this arm receive a Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery
290169|NCT01271855|B1|Baseline|Glycerin Suppository|Women assigned to this arm receive a vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.
290170|NCT01271855|P2|Participant Flow|Belladonna and Opioid Suppository|Women assigned to this arm receive a Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery
290171|NCT01271855|P1|Participant Flow|Glycerin Suppository|Women assigned to this arm receive a vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.
290172|NCT01271855|O2|Outcome|Belladonna and Opioid Suppository|Women assigned to this arm receive a Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery
290173|NCT01271855|O1|Outcome|Glycerin Suppository|Women assigned to this arm receive a vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.
290174|NCT01271855|O2|Outcome|Belladonna and Opioid Suppository|Women assigned to this arm receive a Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery
290175|NCT01271855|O1|Outcome|Glycerin Suppository|Women assigned to this arm receive a vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.
290176|NCT01271855|O2|Outcome|Belladonna and Opioid Suppository|Women assigned to this arm receive a Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery
290177|NCT01271855|O1|Outcome|Glycerin Suppository|Women assigned to this arm receive a vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.
290178|NCT01271855|E2|Reported Event|Belladonna and Opioid Suppository|Women assigned to this arm receive a Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery
290179|NCT01271855|E1|Reported Event|Glycerin Suppository|Women assigned to this arm receive a vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.
290180|NCT01271803|B13|Baseline|Total|Total of all reporting groups
290181|NCT01271803|B12|Baseline|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290182|NCT01271803|B11|Baseline|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290183|NCT01271803|B10|Baseline|Cobimetinib Monotherapy (100 mg or 60 mg)|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule, or oral 100 mg cobimetinib QD on 14/14 dosing schedule of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290184|NCT01271803|B9|Baseline|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290185|NCT01271803|B8|Baseline|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290186|NCT01271803|B7|Baseline|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290187|NCT01271803|B6|Baseline|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290188|NCT01271803|B5|Baseline|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290189|NCT01271803|B4|Baseline|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290190|NCT01271803|B3|Baseline|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290191|NCT01271803|B2|Baseline|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290192|NCT01271803|B1|Baseline|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290193|NCT01271803|P12|Participant Flow|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290194|NCT01271803|P11|Participant Flow|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290195|NCT01271803|P10|Participant Flow|Cobimetinib Monotherapy (100 mg or 60 mg)|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule, or oral 100 mg cobimetinib QD on 14/14 dosing schedule of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290196|NCT01271803|P9|Participant Flow|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290197|NCT01271803|P8|Participant Flow|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290198|NCT01271803|P7|Participant Flow|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290399|NCT01271686|P1|Participant Flow|0.01% Bimatoprost|0.01% bimatoprost: 0.01% bimatoprost eye drop once in the evening both eyes for 4 weeks
290199|NCT01271803|P6|Participant Flow|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290200|NCT01271803|P5|Participant Flow|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290201|NCT01271803|P4|Participant Flow|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on Days 1-28 (28/0 dosing schedule) and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290202|NCT01271803|P3|Participant Flow|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290203|NCT01271803|P2|Participant Flow|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on Days 1-21, followed by 7 days off on Days 22-28 (21/7 dosing schedule) and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290204|NCT01271803|P1|Participant Flow|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 milligrams (mg) cobimetinib once daily (QD) on Days 1-14, followed by 14 days off on Days 15-28 (14/14 dosing schedule) and oral 720 mg vemurafenib twice daily (BID) on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290205|NCT01271803|O2|Outcome|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
290206|NCT01271803|O1|Outcome|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment in to this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
290207|NCT01271803|O2|Outcome|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
290208|NCT01271803|O1|Outcome|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment in to this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
290209|NCT01271803|O2|Outcome|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
290210|NCT01271803|O1|Outcome|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment in to this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
290211|NCT01271803|O2|Outcome|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
290212|NCT01271803|O1|Outcome|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment in to this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
290213|NCT01271803|O2|Outcome|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
290214|NCT01271803|O1|Outcome|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment in to this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
290215|NCT01271803|O2|Outcome|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
290400|NCT01271686|O1|Outcome|0.01% Bimatoprost|0.01% bimatoprost: 0.01% bimatoprost eye drop once in the evening both eyes for 4 weeks
326937|NCT01180777|O3|Outcome|Etafilcon A (C)|Daily wear contact lens
290216|NCT01271803|O1|Outcome|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment in to this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
290217|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290218|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290219|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290220|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290221|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290222|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290223|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290224|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290225|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290226|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290227|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290228|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290229|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290230|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290231|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290232|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290233|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290234|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290235|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290236|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290397|NCT01271712|E1|Reported Event|Regorafenib (Double Blind Only)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks. Data cut-off date 26 JAN 2012.
290237|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290238|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290239|NCT01271803|O8|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290240|NCT01271803|O7|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290241|NCT01271803|O6|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290242|NCT01271803|O5|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290243|NCT01271803|O4|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290244|NCT01271803|O3|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290245|NCT01271803|O2|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290246|NCT01271803|O1|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290247|NCT01271803|O1|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290248|NCT01271803|O7|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290249|NCT01271803|O6|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290250|NCT01271803|O5|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290251|NCT01271803|O4|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290252|NCT01271803|O3|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290253|NCT01271803|O2|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290254|NCT01271803|O1|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290255|NCT01271803|O10|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290256|NCT01271803|O9|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290257|NCT01271803|O8|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290258|NCT01271803|O7|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290460|NCT01271036|O1|Outcome|Male|Male Participants
290259|NCT01271803|O6|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290260|NCT01271803|O5|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290261|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290262|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290263|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290264|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290265|NCT01271803|O2|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290266|NCT01271803|O1|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290267|NCT01271803|O8|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290268|NCT01271803|O7|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290269|NCT01271803|O6|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290270|NCT01271803|O5|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290271|NCT01271803|O4|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290272|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290273|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290274|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290275|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290276|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290277|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290278|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290279|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290280|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290281|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290282|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290283|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290284|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290285|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290286|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290287|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290288|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290289|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290290|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290291|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290292|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290293|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290294|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290295|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290296|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290297|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290298|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290299|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290300|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290301|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290302|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290303|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290304|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290305|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290306|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290307|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290308|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290309|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290310|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290311|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290312|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290313|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290314|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290315|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290316|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290317|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290318|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290319|NCT01271803|O1|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290320|NCT01271803|O10|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290321|NCT01271803|O9|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290322|NCT01271803|O8|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290323|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290324|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290325|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290326|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290327|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290328|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290329|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290330|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290331|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290332|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290333|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290334|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290335|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290336|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290337|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290338|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290339|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290340|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290341|NCT01271803|O1|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290342|NCT01271803|O10|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290343|NCT01271803|O9|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290344|NCT01271803|O8|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290345|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290346|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290347|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290348|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290349|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290350|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290351|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290352|NCT01271803|O1|Outcome|Dose Escalation Stage (Stage 1)|All participants who received vemurafenib and cobimetinib in any dose combination during DES, until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
290353|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290354|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290355|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290356|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290357|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290358|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290359|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290360|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290361|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290362|NCT01271803|E12|Reported Event|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290363|NCT01271803|E11|Reported Event|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290364|NCT01271803|E10|Reported Event|Cobimetinib Monotherapy (100 mg or 60 mg)|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule, or oral 100 mg cobimetinib QD on 14/14 dosing schedule of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290365|NCT01271803|E9|Reported Event|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290366|NCT01271803|E8|Reported Event|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290367|NCT01271803|E7|Reported Event|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290368|NCT01271803|E6|Reported Event|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290461|NCT01271036|O2|Outcome|Female|Female Participants
290369|NCT01271803|E5|Reported Event|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290370|NCT01271803|E4|Reported Event|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290371|NCT01271803|E3|Reported Event|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290372|NCT01271803|E2|Reported Event|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290373|NCT01271803|E1|Reported Event|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
290374|NCT01271712|B3|Baseline|Total|Total of all reporting groups
290375|NCT01271712|B2|Baseline|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
290376|NCT01271712|B1|Baseline|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
290377|NCT01271712|P2|Participant Flow|Placebo First, Then Option of Open Label Regorafenib Treatment|Double blind phase: participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks. Open Label phase: participants on placebo who switched to Regorafenib, received Regorafenib 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks.
290378|NCT01271712|P1|Participant Flow|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
290379|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
290380|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
290381|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
290382|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
290383|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
290384|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
290385|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
290386|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
290387|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
290388|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
290389|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
290390|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
290391|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
290392|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
290393|NCT01271712|E5|Reported Event|Treated With Regorafenib for > 1 Year|Treated with Regorafenib for > 1 year (including placebo switched to regorafenib): For more than a year, participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks. Data cut-off date 08 JUN 2015.
290394|NCT01271712|E4|Reported Event|Treated With Regorafenib at Any Time|Treated with Regorafenib at any time (including placebo switched to regorafenib): At any time, participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks. Data cut-off date 08 JUN 2015.
290395|NCT01271712|E3|Reported Event|Placebo, Open Label Only (Switch to Regorafenib)|Participants switched to Open-label Regorafenib treatment from Placebo. Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks. Data cut-off date 08 JUN 2015.
290396|NCT01271712|E2|Reported Event|Placebo (Double Blind Only)|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks. Data cut-off date 26 JAN 2012.
290401|NCT01271686|E1|Reported Event|0.01% Bimatoprost|0.01% bimatoprost: 0.01% bimatoprost eye drop once in the evening both eyes for 4 weeks
290402|NCT01271543|B3|Baseline|Total|Total of all reporting groups
290403|NCT01271543|B2|Baseline|Shikani Optical Stylet|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with Shikani optical stylet (SOS) (one size). Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
290404|NCT01271543|B1|Baseline|MacIntosh Group|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
290405|NCT01271543|P2|Participant Flow|Shikani Optical Stylet|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with Shikani optical stylet (SOS) (one size). Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
290406|NCT01271543|P1|Participant Flow|MacIntosh Group|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
290407|NCT01271543|O2|Outcome|Shikani Optical Stylet|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a Shikani optical stylet (SOS) (one size). Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
290408|NCT01271543|O1|Outcome|MacIntosh Group|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
290409|NCT01271543|O2|Outcome|Shikani Optical Stylet|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a Shikani optical stylet (SOS) (one size). Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
290410|NCT01271543|O1|Outcome|MacIntosh Group|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
290411|NCT01271543|E2|Reported Event|Shikani Optical Stylet|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a Shikani optical stylet (SOS) (one size). Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
290412|NCT01271543|E1|Reported Event|MacIntosh Group|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
290413|NCT01271452|B3|Baseline|Total|Total of all reporting groups
290414|NCT01271452|B2|Baseline|Bocouture®|botulinum toxin type A (Bocouture®)
290415|NCT01271452|B1|Baseline|Vistabel®|botulinum toxin type A (Vistabel®)
290416|NCT01271452|P2|Participant Flow|Bocouture®|botulinum toxin type A (Bocouture®)
290417|NCT01271452|P1|Participant Flow|Vistabel®|botulinum toxin type A (Vistabel®)
290418|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
290419|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
290420|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
290421|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
290422|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
290423|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
290424|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
290425|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
290426|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
290427|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
290428|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
290429|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
290430|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
290431|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
290432|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
290433|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
290434|NCT01271452|E2|Reported Event|Bocouture®|botulinum toxin type A (Bocouture®)
290435|NCT01271452|E1|Reported Event|Vistabel®|botulinum toxin type A (Vistabel®)
290436|NCT01271413|B3|Baseline|Total|Total of all reporting groups
290437|NCT01271413|B2|Baseline|Cognitively Stimulating Activities: Other|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
290438|NCT01271413|B1|Baseline|Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
290439|NCT01271413|P2|Participant Flow|Non-adaptive Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
290440|NCT01271413|P1|Participant Flow|Adaptive Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
290441|NCT01271413|O2|Outcome|Non-adaptive Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
290442|NCT01271413|O1|Outcome|Adaptive Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
290443|NCT01271413|E2|Reported Event|Cognitively Stimulating Activities: Other|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
290444|NCT01271413|E1|Reported Event|Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
290445|NCT01271244|B3|Baseline|Total|Total of all reporting groups
290446|NCT01271244|B2|Baseline|Major Depression Group|Veterans with Depression only will receive Escitalopram: 10-20mg daily for 12 weeks
290447|NCT01271244|B1|Baseline|PTSD Depression Group|Veterans with PTSD and Depression will receive Escitalopram: 10-20mg daily for 12 weeks
290448|NCT01271244|P2|Participant Flow|Major Depression Group|Veteran with Depression only will receive Escitalopram: 10-20mg daily for 12 weeks
290449|NCT01271244|P1|Participant Flow|PTSD Depression Group|Veterans with PTSD and depression will receive Escitalopram: 10-20mg daily for 12 weeks
290450|NCT01271244|O2|Outcome|Major Depression Group|Veterans with major depression onny receive Escitalopram: 10-20mg daily for 12 weeks
290451|NCT01271244|O1|Outcome|PTSD Depression Group|Veterans with PTSD and depession will receive Escitalopram: 10-20mg daily for 12 weeks
290452|NCT01271244|E2|Reported Event|Major Depression Group|Veterans with Major Depression only receive Escitalopram: 10-20mg daily for 12 weeks
290453|NCT01271244|E1|Reported Event|PTSD Depression Group|Veterans with PTSD and depression will receive Escitalopram: 10-20mg daily for 12 weeks
290454|NCT01271036|B3|Baseline|Total|Total of all reporting groups
290455|NCT01271036|B2|Baseline|Female|Female Participants
290456|NCT01271036|B1|Baseline|Male|Male Participants
290457|NCT01271036|P2|Participant Flow|Female|Female Participants (K-Y Brand TOUCH 2-in-1)
290458|NCT01271036|P1|Participant Flow|Males|Male Participants (K-Y Brand TOUCH 2-in-1)
290459|NCT01271036|O2|Outcome|Female|Female Participants
290471|NCT01271010|B1|Baseline|Rituximab + Fludarabine + Cyclophosphamide|Participants received rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each.
290472|NCT01271010|P1|Participant Flow|Rituximab + Fludarabine + Cyclophosphamide|Participants received rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each.
290473|NCT01271010|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants received rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each.
290474|NCT01271010|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants received rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each.
290475|NCT01271010|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants received rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each.
290476|NCT01271010|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants received rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each.
290477|NCT01271010|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants received rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each.
290478|NCT01271010|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants received rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each.
290479|NCT01271010|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants received rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each.
290480|NCT01271010|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants received rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each.
290481|NCT01271010|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants received rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each.
290482|NCT01271010|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants received rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each.
290483|NCT01271010|E1|Reported Event|Rituximab + Fludarabine + Cyclophosphamide|Participants received rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each.
290484|NCT01270971|B3|Baseline|Total|Total of all reporting groups
290485|NCT01270971|B2|Baseline|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
290486|NCT01270971|B1|Baseline|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
290487|NCT01270971|P2|Participant Flow|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
290488|NCT01270971|P1|Participant Flow|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
290489|NCT01270971|O2|Outcome|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
290490|NCT01270971|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
290491|NCT01270971|O2|Outcome|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
290492|NCT01270971|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
290493|NCT01270971|O2|Outcome|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
290797|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
290494|NCT01270971|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
290495|NCT01270971|O2|Outcome|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
290496|NCT01270971|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
290497|NCT01270971|E2|Reported Event|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
290498|NCT01270971|E1|Reported Event|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
290499|NCT01270958|B1|Baseline|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
290500|NCT01270958|P1|Participant Flow|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
290501|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
290502|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
290503|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
290504|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
290505|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
290506|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
290507|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
290508|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
290509|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
290510|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
290511|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
290512|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
290513|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
290514|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
290515|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
290516|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
290517|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
290518|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
290519|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
290520|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
290521|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
290522|NCT01270958|E1|Reported Event|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
290523|NCT01270919|B1|Baseline|BioDuct Meniscal Repair Device|"BioDuct Meniscal Repair Device~BioDuct Meniscal Repair Device: The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.~The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear."
290524|NCT01270919|P1|Participant Flow|BioDuct Meniscal Repair Device|"BioDuct Meniscal Repair Device~BioDuct Meniscal Repair Device: The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.~The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear."
290550|NCT01270841|B4|Baseline|Androxal 25 mg|"Androxal 25 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
290551|NCT01270841|B3|Baseline|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
290552|NCT01270841|B2|Baseline|Testim (Topical Testosterone)|"Testim (topical testosterone)~topical testosterone: testosterone gel applied 1x daily for 3 months"
290553|NCT01270841|B1|Baseline|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
290554|NCT01270841|P4|Participant Flow|Androxal 25 mg|"Androxal 25 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
290525|NCT01270919|O1|Outcome|BioDuct Meniscal Repair Device|"BioDuct Meniscal Repair Device~BioDuct Meniscal Repair Device: The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.~The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear."
290526|NCT01270919|O1|Outcome|BioDuct Meniscal Repair Device|"BioDuct Meniscal Repair Device~BioDuct Meniscal Repair Device: The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.~The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear."
290527|NCT01270919|E1|Reported Event|BioDuct Meniscal Repair Device|"BioDuct Meniscal Repair Device~BioDuct Meniscal Repair Device: The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.~The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear."
290528|NCT01270880|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Hsp90 inhibitor STA-9090: Given IV~laboratory biomarker analysis: Correlative studies~polymerase chain reaction: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~RNA analysis: Correlative studies~spectrophotometry: Correlative studies~reverse transcriptase-polymerase chain reaction: Correlative studies~gene expression analysis: Correlative studies"
290529|NCT01270880|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|"Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Hsp90 inhibitor STA-9090: Given IV~laboratory biomarker analysis: Correlative studies~polymerase chain reaction: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~RNA analysis: Correlative studies~spectrophotometry: Correlative studies~reverse transcriptase-polymerase chain reaction: Correlative studies~gene expression analysis: Correlative studies"
290530|NCT01270880|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Hsp90 inhibitor STA-9090: Given IV~laboratory biomarker analysis: Correlative studies~polymerase chain reaction: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~RNA analysis: Correlative studies~spectrophotometry: Correlative studies~reverse transcriptase-polymerase chain reaction: Correlative studies~gene expression analysis: Correlative studies"
290531|NCT01270880|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|"Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Hsp90 inhibitor STA-9090: Given IV~laboratory biomarker analysis: Correlative studies~polymerase chain reaction: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~RNA analysis: Correlative studies~spectrophotometry: Correlative studies~reverse transcriptase-polymerase chain reaction: Correlative studies~gene expression analysis: Correlative studies"
290532|NCT01270867|B3|Baseline|Total|Total of all reporting groups
290533|NCT01270867|B2|Baseline|Trevo Stentriever|Patients who were randomized to the Trevo Stentriever
290534|NCT01270867|B1|Baseline|Merci Retriever|Patients who were randomized to the Merci Retriever
290535|NCT01270867|P2|Participant Flow|Trevo Stentriever|Patients who were randomized to the Trevo Stentriever
290536|NCT01270867|P1|Participant Flow|Merci Retriever|Patients who were randomized to the Merci Retriever
290537|NCT01270867|O2|Outcome|Trevo Stentriever|Patients who were randomized to receive the Trevo Stentriever.
290538|NCT01270867|O1|Outcome|Merci Retriever|Patients who were randomized to receive the Merci Retriever.
290539|NCT01270867|O2|Outcome|Trevo Stentriever|Patients who were randomized to receive the Trevo Stentriever.
290540|NCT01270867|O1|Outcome|Merci Retriever|Patients who were randomized to receive the Merci Retriever.
290541|NCT01270867|O2|Outcome|Trevo Stentriever|Patients who were randomized to receive the Trevo Stentriever.
290542|NCT01270867|O1|Outcome|Merci Retriever|Patients who were randomized to receive the Merci Retriever.
290543|NCT01270867|O2|Outcome|Trevo Stentriever|Patients who were randomized to receive the Trevo Stentriever.
290544|NCT01270867|O1|Outcome|Merci Retriever|Patients who were randomized to receive the Merci Retriever.
290545|NCT01270867|O2|Outcome|Trevo Stentriever|Patients who were randomized to receive the Trevo Stentriever.
290546|NCT01270867|O1|Outcome|Merci Retriever|Patients who were randomized to receive the Merci Retriever.
290547|NCT01270867|E2|Reported Event|Trevo Stentriever|Patients who were randomized to receive the Trevo Stentriever.
290548|NCT01270867|E1|Reported Event|Merci Retriever|Patients who were randomized to receive the Merci Retriever.
290555|NCT01270841|P3|Participant Flow|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
290556|NCT01270841|P2|Participant Flow|Testim (Topical Testosterone)|"Testim (topical testosterone)~topical testosterone: testosterone gel applied 1x daily for 3 months"
290557|NCT01270841|P1|Participant Flow|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
290558|NCT01270841|O4|Outcome|Androxal 25 mg|"Androxal 25 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
290559|NCT01270841|O3|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
290560|NCT01270841|O2|Outcome|Testim (Topical Testosterone)|"Testim (topical testosterone)~topical testosterone: testosterone gel applied 1x daily for 3 months"
290561|NCT01270841|O1|Outcome|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
290562|NCT01270841|O4|Outcome|Androxal 25 mg|"Androxal 25 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
290563|NCT01270841|O3|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
290564|NCT01270841|O2|Outcome|Testim (Topical Testosterone)|"Testim (topical testosterone)~topical testosterone: testosterone gel applied 1x daily for 3 months"
290565|NCT01270841|O1|Outcome|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
290566|NCT01270841|O4|Outcome|Androxal 25 mg|"Androxal 25 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
290567|NCT01270841|O3|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
290568|NCT01270841|O2|Outcome|Testim (Topical Testosterone)|"Testim (topical testosterone)~topical testosterone: testosterone gel applied 1x daily for 3 months"
290569|NCT01270841|O1|Outcome|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
290570|NCT01270841|O4|Outcome|Androxal 25 mg|"Androxal 25 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
290571|NCT01270841|O3|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
290572|NCT01270841|O2|Outcome|Testim (Topical Testosterone)|"Testim (topical testosterone)~topical testosterone: testosterone gel applied 1x daily for 3 months"
290573|NCT01270841|O1|Outcome|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
290574|NCT01270841|E4|Reported Event|Androxal 25 mg|"Androxal 25 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
290575|NCT01270841|E3|Reported Event|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
290576|NCT01270841|E2|Reported Event|Testim (Topical Testosterone)|"Testim (topical testosterone)~topical testosterone: testosterone gel applied 1x daily for 3 months"
290577|NCT01270841|E1|Reported Event|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
290578|NCT01270828|B3|Baseline|Total|Total of all reporting groups
290579|NCT01270828|B2|Baseline|Placebo DB|Participants received matching placebo
290580|NCT01270828|B1|Baseline|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
290581|NCT01270828|P3|Participant Flow|Pregabalin CR SB|The participants with normal CLcr (≥60 mL/min) were treated with pregabalin 165 mg/day CR; those with low CLcr (>30 - <60 mL/min) received 82.5 mg/day pregabalin CR. Subsequently, the pregabalin doses were increased based on efficacy and tolerability at each weekly visit.
290582|NCT01270828|P2|Participant Flow|Placebo DB|Participants received matching placebo
290583|NCT01270828|P1|Participant Flow|Pregabalin Controlled Release (CR) DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
290584|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
290585|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
290586|NCT01270828|O3|Outcome|Pregabalin CR SB|The participants with normal CLcr (≥60 mL/min) were treated with pregabalin 165 mg/day CR; those with low CLcr (>30 - <60 mL/min) received 82.5 mg/day pregabalin CR. Subsequently, the pregabalin doses were increased based on efficacy and tolerability at each weekly visit.
290587|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
290588|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
290589|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
290590|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
290591|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
290592|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
290593|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
290780|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
290781|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
290594|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
290595|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
290596|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
290597|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
290598|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
290599|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
290600|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
290601|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
290602|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
290603|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
290604|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
290605|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
290606|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
290607|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
290608|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
290609|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
290610|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
290611|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
290612|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
290613|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
290614|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
290615|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
290616|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
290617|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
290618|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
290619|NCT01270828|E3|Reported Event|Pregabalin CR SB|The participants with normal CLcr (≥60 mL/min) were treated with pregabalin 165 mg/day CR; those with low CLcr (>30 - <60 mL/min) received 82.5 mg/day pregabalin CR. Subsequently, the pregabalin doses were increased based on efficacy and tolerability at each weekly visit.
290620|NCT01270828|E2|Reported Event|Placebo DB|Participants received matching placebo
290621|NCT01270828|E1|Reported Event|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
290622|NCT01270802|B3|Baseline|Total|Total of all reporting groups
290623|NCT01270802|B2|Baseline|Switch to Tenofovir/Emtricitabine/Raltegravir|"Tenofovir/emtricitabine/efavirenz is switched to tenofovir/emtricitabine/raltegravir~Tenofovir/emtricitabine/raltegravir : Efavirenz will be switched to raltegravir 400mg orally twice daily while continuing tenofovir/emtricitabine"
290624|NCT01270802|B1|Baseline|Continued Tenofovir/Emtricitabine/Efavirenz|Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz
326938|NCT01180777|O2|Outcome|Etafilcon A (B)|Daily wear contact lens
290625|NCT01270802|P2|Participant Flow|Switch to Tenofovir/Emtricitabine Plus Raltegravir|Tenofovir/emtricitabine/raltegravir : Tenofovir/emtricitabine/efavirenz (as Atripla one pill per day) will be switched to tenofovir/emtricitabine (as Truvada one pill per day) plus raltegravir (as Isentress) 400mg orally twice daily
290626|NCT01270802|P1|Participant Flow|Continued Tenofovir/Emtricitabine/Efavirenz|Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz (as Atripla) one pill per day
290627|NCT01270802|O2|Outcome|Switch to Tenofovir/Emtricitabine Plus Raltegravir|Tenofovir/emtricitabine/efavirenz will be switched to tenofovir/emtricitabine plus raltegravir 400mg orally twice daily
290628|NCT01270802|O1|Outcome|Continued Tenofovir/Emtricitabine/Efavirenz|Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz
290629|NCT01270802|O2|Outcome|Switch to Tenofovir/Emtricitabine Plus Raltegravir|Tenofovir/emtricitabine plus raltegravir 400mg orally twice daily
290630|NCT01270802|O1|Outcome|Continued Tenofovir/Emtricitabine/Efavirenz|Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz
290631|NCT01270802|E2|Reported Event|Switch to Tenofovir/Emtricitabine/Raltegravir|"Tenofovir/emtricitabine/efavirenz is switched to tenofovir/emtricitabine/raltegravir~Tenofovir/emtricitabine/raltegravir : Efavirenz will be switched to raltegravir 400mg orally twice daily while continuing tenofovir/emtricitabine"
290632|NCT01270802|E1|Reported Event|Continued Tenofovir/Emtricitabine/Efavirenz|Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz
290633|NCT01270711|B9|Baseline|Total|Total of all reporting groups
290634|NCT01270711|B8|Baseline|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to date of the recommended SPC change, 26 June 2008 (Week 130) and continued treatment after the recommended change to the SPC.
290635|NCT01270711|B7|Baseline|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
290636|NCT01270711|B6|Baseline|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
290637|NCT01270711|B5|Baseline|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
290638|NCT01270711|B4|Baseline|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
290639|NCT01270711|B3|Baseline|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
290640|NCT01270711|B2|Baseline|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
290641|NCT01270711|B1|Baseline|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
290642|NCT01270711|P8|Participant Flow|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to date of the recommended SPC change, 26 June 2008 (Week 130) and continued treatment after the recommended change to the SPC.
290643|NCT01270711|P7|Participant Flow|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
290644|NCT01270711|P6|Participant Flow|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
290645|NCT01270711|P5|Participant Flow|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
290646|NCT01270711|P4|Participant Flow|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
290647|NCT01270711|P3|Participant Flow|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
290648|NCT01270711|P2|Participant Flow|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
290782|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
290783|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
290649|NCT01270711|P1|Participant Flow|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
290650|NCT01270711|O3|Outcome|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to SPC change (26 June 2008) and continued treatment after the recommended change to the SPC.
290651|NCT01270711|O2|Outcome|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
290652|NCT01270711|O1|Outcome|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
290653|NCT01270711|O3|Outcome|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to SPC change (26 June 2008) and continued treatment after the recommended change to the SPC.
290654|NCT01270711|O2|Outcome|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
290655|NCT01270711|O1|Outcome|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
290656|NCT01270711|O3|Outcome|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to SPC change (26 June 2008) and continued treatment after the recommended change to the SPC.
290657|NCT01270711|O2|Outcome|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
290658|NCT01270711|O1|Outcome|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
290659|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
290660|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
290661|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
290662|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
290663|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
290664|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
290665|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
290666|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
290667|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
290668|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
290669|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
290784|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
290785|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
290670|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
290671|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
290672|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
290673|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
290674|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
290675|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
290676|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
290677|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
290678|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
290679|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
290680|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
290681|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
290682|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
290683|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
290684|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
290685|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
290686|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
290687|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
290786|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
290787|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
290688|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
290689|NCT01270711|O3|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
290690|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
290691|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
290692|NCT01270711|O3|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
290693|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
290694|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
290695|NCT01270711|O3|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
290696|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
290697|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
290698|NCT01270711|O3|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
290699|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
290700|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
290701|NCT01270711|O3|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
290702|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
290703|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
290704|NCT01270711|O3|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
290705|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
290706|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
290788|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
290789|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
290790|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
290707|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
290708|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
290709|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
290710|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
290711|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
290712|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
290713|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
290714|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
290715|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
290716|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
290717|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
290718|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
290719|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
290720|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
290721|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
290722|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
290723|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
290724|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
290791|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
290792|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
290725|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
290726|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
290727|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
290728|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
290729|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
290730|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
290731|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
290732|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
290733|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
290734|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
290735|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
290736|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
290737|NCT01270711|E8|Reported Event|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to date of the recommended SPC change, 26 June 2008 (Week 130) and continued treatment after the recommended change to the SPC.
290738|NCT01270711|E7|Reported Event|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
290739|NCT01270711|E6|Reported Event|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
290740|NCT01270711|E5|Reported Event|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
290741|NCT01270711|E4|Reported Event|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
290742|NCT01270711|E3|Reported Event|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
290743|NCT01270711|E2|Reported Event|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
290793|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
326939|NCT01180777|O1|Outcome|Etafilcon A (A)|Daily wear contact lens
290744|NCT01270711|E1|Reported Event|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
290745|NCT01270659|B5|Baseline|Total|Total of all reporting groups
290746|NCT01270659|B4|Baseline|High Control|"Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl placebo~oxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time"
290747|NCT01270659|B3|Baseline|Low Control|"Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl placebo~Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once"
290748|NCT01270659|B2|Baseline|High-FBT|"Subject will receive the high dose regimen of FBT and a high dose placebo~Fentanyl: Fentanyl buccal tablet 200 mcg once"
290749|NCT01270659|B1|Baseline|Low-FBT|"Subject will receive FBT and placebo at a low dose~Fentanyl: Fentanyl buccal tablet 100 mcg once"
290750|NCT01270659|P4|Participant Flow|High Control|"Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl placebo~oxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time"
290751|NCT01270659|P3|Participant Flow|Low Control|"Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl placebo~Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once"
290752|NCT01270659|P2|Participant Flow|High-FBT|"Subject will receive the high dose regimen of FBT and a high dose placebo~Fentanyl: Fentanyl buccal tablet 200 mcg once"
290753|NCT01270659|P1|Participant Flow|Low-FBT|"Subject will receive FBT and placebo at a low dose~Fentanyl: Fentanyl buccal tablet 100 mcg once"
290754|NCT01270659|O4|Outcome|High Control|"Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl placebo~oxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time"
290755|NCT01270659|O3|Outcome|Low Control|"Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl placebo~Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once"
290756|NCT01270659|O2|Outcome|High-FBT|"Subject will receive the high dose regimen of FBT and a high dose placebo~Fentanyl: Fentanyl buccal tablet 200 mcg once"
290757|NCT01270659|O1|Outcome|Low-FBT|"Subject will receive FBT and placebo at a low dose~Fentanyl: Fentanyl buccal tablet 100 mcg once"
290758|NCT01270659|O4|Outcome|High Control|"Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl placebo~oxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time"
290759|NCT01270659|O3|Outcome|Low Control|"Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl placebo~Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once"
290760|NCT01270659|O2|Outcome|High-FBT|"Subject will receive the high dose regimen of FBT and a high dose placebo~Fentanyl: Fentanyl buccal tablet 200 mcg once"
290761|NCT01270659|O1|Outcome|Low-FBT|"Subject will receive FBT and placebo at a low dose~Fentanyl: Fentanyl buccal tablet 100 mcg once"
290762|NCT01270659|O4|Outcome|High Control|"Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl placebo~oxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time"
290763|NCT01270659|O3|Outcome|Low Control|"Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl placebo~Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once"
290764|NCT01270659|O2|Outcome|High-FBT|"Subject will receive the high dose regimen of FBT and a high dose placebo~Fentanyl: Fentanyl buccal tablet 200 mcg once"
290765|NCT01270659|O1|Outcome|Low-FBT|"Subject will receive FBT and placebo at a low dose~Fentanyl: Fentanyl buccal tablet 100 mcg once"
290766|NCT01270659|E4|Reported Event|High Control|"Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl placebo~oxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time"
290767|NCT01270659|E3|Reported Event|Low Control|"Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl placebo~Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once"
290768|NCT01270659|E2|Reported Event|High-FBT|"Subject will receive the high dose regimen of FBT and a high dose placebo~Fentanyl: Fentanyl buccal tablet 200 mcg once"
290769|NCT01270659|E1|Reported Event|Low-FBT|"Subject will receive FBT and placebo at a low dose~Fentanyl: Fentanyl buccal tablet 100 mcg once"
290770|NCT01270620|B3|Baseline|Total|Total of all reporting groups
290771|NCT01270620|B2|Baseline|Propofol|"Patients received propofol or desflurane as general anesthetic for total knee replacement.~Inclusion criteria: Age > 65 years old; BMI > 30 kg/m2; undergoing primary total knee replacement surgery; and ASA classification II-III"
290772|NCT01270620|B1|Baseline|Desflurane|"Patients received propofol or desflurane as general anesthetic for total knee replacement.~Inclusion criteria: Age > 65 years old; BMI > 30 kg/m2; undergoing primary total knee replacement surgery; and ASA classification II-III"
290773|NCT01270620|P2|Participant Flow|Propofol Group|"Patients will receive propofol as general anesthetic Propofol is an intravenous agent which will be provided continuously via IV in doses varying from 100 to 200 mcg/kg/min according to BIS monitoring.~Propofol: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
290774|NCT01270620|P1|Participant Flow|Desflurane Group|"Patients will receive desflurane as general anesthetic. Desflurane is inhaled agent which will be provided continuously via ETT in concentrations varying from 4-6% according to BIS monitoring.~Desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
290775|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
290776|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
290777|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
290778|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
290779|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
290798|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
290799|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
290800|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
290801|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
290802|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
290803|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
290804|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
290805|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
290806|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
290807|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
290808|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
290809|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
290810|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
290811|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
290812|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
290813|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
290814|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
290815|NCT01270620|O2|Outcome|Propofol|Patients received propofol as general anesthetic
290816|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as general anesthetic
290817|NCT01270620|O2|Outcome|Propofol|Patients received propofol as general anesthetic
290818|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as general anesthetic
290819|NCT01270620|O2|Outcome|Propofol|"Patients received propofol as general anesthetic~propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
290820|NCT01270620|O1|Outcome|Desflurane|"Patients received desflurane as general anesthetic~propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
290821|NCT01270620|E2|Reported Event|Propofol|"Patients will receive propofol as general anesthetic~propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
290822|NCT01270620|E1|Reported Event|Desflurane|"Patients will receive desflurane as general anesthetic~propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
290823|NCT01270581|B3|Baseline|Total|Total of all reporting groups
290824|NCT01270581|B2|Baseline|Control Group- Bubble Nasal CPAP|NCPAP provides continuous distending airway pressure during inspiration and expiration via nasal prongs; this has been shown to increase lung volume by increasing alveolar size, recruiting collapsed alveoli, and preventing atelectasis. Improved lung volumes decrease V/Q mismatch and improve the clinical course of neonates with RDS, and as such, early NCPAP use often avoids the need for intubation and mechanical ventilation. Newborns receiving bubble NCPAP will be placed on a PEEP 5cm H2O, and supplemental oxygen will be provided to maintain oxygen saturation between 88-93% (standard of care group) as is standard practice. The size of the nasal prongs used will be based on the subject's weight as per the manufacturer instructions.
290825|NCT01270581|B1|Baseline|High Flow Nasal Cannula|Unlike the nasal prongs for NCPAP (which fit tightly in the nares), the nasal cannula for HFNC have smaller, loose-fitting prong. With HFNC, positive airway pressure is achieved by high gas flow through the cannula into the external nares which provide resistance to expiration and facilitate inspiration. The distending pressure is determined by the size and structure of the nasal cannula, gas flow rate, and the neonate's airway anatomy 4,5,7. Newborns randomized to HFNC will be started on a flow rate of 4L/min and supplemental oxygen will be provided to maintain oxygen saturations between 88-93% (experimental group). Once initiated, the gas flow rate will be titrated as needed by the attending neonatologist to ameliorate signs of respiratory distress to a maximum flow rate of 6L/min. The nasal cannula size (0.2 cm or 0.3 mm outer diameter) will determined by the caliber of the subject's nares).
290826|NCT01270581|P2|Participant Flow|Control Group- Bubble Nasal CPAP|NCPAP provides continuous distending airway pressure during inspiration and expiration via nasal prongs; this has been shown to increase lung volume by increasing alveolar size, recruiting collapsed alveoli, and preventing atelectasis. Improved lung volumes decrease V/Q mismatch and improve the clinical course of neonates with RDS, and as such, early NCPAP use often avoids the need for intubation and mechanical ventilation. Newborns receiving bubble NCPAP will be placed on a PEEP 5cm H2O, and supplemental oxygen will be provided to maintain oxygen saturation between 88-93% (standard of care group) as is standard practice. The size of the nasal prongs used will be based on the subject's weight as per the manufacturer instructions.
290827|NCT01270581|P1|Participant Flow|High Flow Nasal Cannula|Unlike the nasal prongs for NCPAP (which fit tightly in the nares), the nasal cannula for HFNC have smaller, loose-fitting prong. With HFNC, positive airway pressure is achieved by high gas flow through the cannula into the external nares which provide resistance to expiration and facilitate inspiration. The distending pressure is determined by the size and structure of the nasal cannula, gas flow rate, and the neonate's airway anatomy 4,5,7. Newborns randomized to HFNC will be started on a flow rate of 4L/min and supplemental oxygen will be provided to maintain oxygen saturations between 88-93% (experimental group). Once initiated, the gas flow rate will be titrated as needed by the attending neonatologist to ameliorate signs of respiratory distress to a maximum flow rate of 6L/min. The nasal cannula size (0.2 cm or 0.3 mm outer diameter) will determined by the caliber of the subject's nares).
290854|NCT01270542|E1|Reported Event|Avastin Injection Group (AIG)|Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
290855|NCT01270529|B4|Baseline|Total|Total of all reporting groups
290878|NCT01270464|P2|Participant Flow|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
326941|NCT01180660|B3|Baseline|Total|Total of all reporting groups
290828|NCT01270581|O2|Outcome|Control Group- Bubble Nasal CPAP|NCPAP provides continuous distending airway pressure during inspiration and expiration via nasal prongs; this has been shown to increase lung volume by increasing alveolar size, recruiting collapsed alveoli, and preventing atelectasis. Improved lung volumes decrease V/Q mismatch and improve the clinical course of neonates with RDS, and as such, early NCPAP use often avoids the need for intubation and mechanical ventilation. Newborns receiving bubble NCPAP will be placed on a PEEP 5cm H2O, and supplemental oxygen will be provided to maintain oxygen saturation between 88-93% (standard of care group) as is standard practice. The size of the nasal prongs used will be based on the subject's weight as per the manufacturer instructions.
290829|NCT01270581|O1|Outcome|High Flow Nasal Cannula|Unlike the nasal prongs for NCPAP (which fit tightly in the nares), the nasal cannula for HFNC have smaller, loose-fitting prong. With HFNC, positive airway pressure is achieved by high gas flow through the cannula into the external nares which provide resistance to expiration and facilitate inspiration. The distending pressure is determined by the size and structure of the nasal cannula, gas flow rate, and the neonate's airway anatomy 4,5,7. Newborns randomized to HFNC will be started on a flow rate of 4L/min and supplemental oxygen will be provided to maintain oxygen saturations between 88-93% (experimental group). Once initiated, the gas flow rate will be titrated as needed by the attending neonatologist to ameliorate signs of respiratory distress to a maximum flow rate of 6L/min. The nasal cannula size (0.2 cm or 0.3 mm outer diameter) will determined by the caliber of the subject's nares).
290830|NCT01270581|E2|Reported Event|Control Group- Bubble Nasal CPAP|NCPAP provides continuous distending airway pressure during inspiration and expiration via nasal prongs; this has been shown to increase lung volume by increasing alveolar size, recruiting collapsed alveoli, and preventing atelectasis. Improved lung volumes decrease V/Q mismatch and improve the clinical course of neonates with RDS, and as such, early NCPAP use often avoids the need for intubation and mechanical ventilation. Newborns receiving bubble NCPAP will be placed on a PEEP 5cm H2O, and supplemental oxygen will be provided to maintain oxygen saturation between 88-93% (standard of care group) as is standard practice. The size of the nasal prongs used will be based on the subject's weight as per the manufacturer instructions.
290831|NCT01270581|E1|Reported Event|High Flow Nasal Cannula|Unlike the nasal prongs for NCPAP (which fit tightly in the nares), the nasal cannula for HFNC have smaller, loose-fitting prong. With HFNC, positive airway pressure is achieved by high gas flow through the cannula into the external nares which provide resistance to expiration and facilitate inspiration. The distending pressure is determined by the size and structure of the nasal cannula, gas flow rate, and the neonate's airway anatomy 4,5,7. Newborns randomized to HFNC will be started on a flow rate of 4L/min and supplemental oxygen will be provided to maintain oxygen saturations between 88-93% (experimental group). Once initiated, the gas flow rate will be titrated as needed by the attending neonatologist to ameliorate signs of respiratory distress to a maximum flow rate of 6L/min. The nasal cannula size (0.2 cm or 0.3 mm outer diameter) will determined by the caliber of the subject's nares).
290832|NCT01270555|B1|Baseline|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
290833|NCT01270555|P1|Participant Flow|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
290834|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
290835|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
290836|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
290837|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
290838|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
290839|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
290840|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
290841|NCT01270555|E1|Reported Event|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
290842|NCT01270542|B3|Baseline|Total|Total of all reporting groups
290843|NCT01270542|B2|Baseline|Sham Injection Group (SIG)|Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
290844|NCT01270542|B1|Baseline|Avastin Injection Group (AIG)|Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
290845|NCT01270542|P2|Participant Flow|Sham Injection Group (SIG)|Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
290846|NCT01270542|P1|Participant Flow|Avastin Injection Group (AIG)|Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
290847|NCT01270542|O2|Outcome|Sham Injection|Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
290848|NCT01270542|O1|Outcome|Avastin (Bevacizumab)|Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
290849|NCT01270542|O2|Outcome|Sham Injection|Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
290850|NCT01270542|O1|Outcome|Avastin (Bevacizumab)|Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
290851|NCT01270542|O2|Outcome|Sham Injection|Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
290852|NCT01270542|O1|Outcome|Avastin (Bevacizumab)|Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
290853|NCT01270542|E2|Reported Event|Sham Injection Group (SIG)|Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
290856|NCT01270529|B3|Baseline|Kidney Transplant Recipients|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
290857|NCT01270529|B2|Baseline|ESRD on Dialysis|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
290858|NCT01270529|B1|Baseline|CKD Stages 1-4|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
290859|NCT01270529|P3|Participant Flow|Kidney Transplant Recipients|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
290860|NCT01270529|P2|Participant Flow|ESRD on Dialysis|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
290861|NCT01270529|P1|Participant Flow|CKD Stages 1-4|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
290862|NCT01270529|O3|Outcome|Kidney Transplant Recipients|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
290863|NCT01270529|O2|Outcome|ESRD on Dialysis|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
290864|NCT01270529|O1|Outcome|CKD Stages 1-4|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
290865|NCT01270529|E3|Reported Event|Kidney Transplant Recipients|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
290866|NCT01270529|E2|Reported Event|ESRD on Dialysis|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
290867|NCT01270529|E1|Reported Event|CKD Stages 1-4|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
290868|NCT01270503|B1|Baseline|Menactra® Vaccine Group|Participants who received a single dose of Menactra vaccine
290869|NCT01270503|P1|Participant Flow|Menactra® Vaccine Group|Participants who received a single dose of Menactra vaccine
290870|NCT01270503|O1|Outcome|Menactra® Vaccine Group|Participants received a single dose of Menactra vaccine
290871|NCT01270503|O1|Outcome|Menactra® Vaccine Group|Participants who received a single dose of Menactra vaccine
290872|NCT01270503|E1|Reported Event|Menactra® Vaccine Group|Participants who received a single dose of Menactra vaccine
290873|NCT01270464|B4|Baseline|Total|Total of all reporting groups
290874|NCT01270464|B3|Baseline|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290875|NCT01270464|B2|Baseline|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
290876|NCT01270464|B1|Baseline|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290877|NCT01270464|P3|Participant Flow|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290879|NCT01270464|P1|Participant Flow|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290880|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290881|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
290882|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290883|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290884|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
290885|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290886|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290887|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
290888|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290889|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290890|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
290891|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290892|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290893|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
290894|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290895|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290896|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
290897|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290898|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290899|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
290900|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290901|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290902|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
290903|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290904|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290905|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
290906|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290907|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290908|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
290909|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290910|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290911|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
290912|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290913|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290914|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
290915|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290916|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290917|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
290918|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290919|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290920|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
290921|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290922|NCT01270464|E3|Reported Event|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290923|NCT01270464|E2|Reported Event|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
290924|NCT01270464|E1|Reported Event|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
290925|NCT01270256|B3|Baseline|Total|Total of all reporting groups
290926|NCT01270256|B2|Baseline|Placebo|Placebo delivered intranasally via NasoNeb nebulizer once daily
290927|NCT01270256|B1|Baseline|Budesonide|Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
290928|NCT01270256|P2|Participant Flow|Placebo|Placebo delivered intranasally via NasoNeb nebulizer once daily
290929|NCT01270256|P1|Participant Flow|Budesonide|Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
290930|NCT01270256|O2|Outcome|Placebo|Placebo delivered intranasally via NasoNeb nebulizer once daily
290931|NCT01270256|O1|Outcome|Budesonide|Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
290932|NCT01270256|E2|Reported Event|Placebo|Placebo delivered intranasally via NasoNeb nebulizer once daily
290933|NCT01270256|E1|Reported Event|Budesonide|Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
290934|NCT01270139|B4|Baseline|Total|Total of all reporting groups
290935|NCT01270139|B3|Baseline|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
290936|NCT01270139|B2|Baseline|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogeneic stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
290937|NCT01270139|B1|Baseline|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogeneic stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
290938|NCT01270139|P3|Participant Flow|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
290939|NCT01270139|P2|Participant Flow|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogeneic stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
290940|NCT01270139|P1|Participant Flow|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogeneic stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
290941|NCT01270139|O2|Outcome|Sham|Blood for ex-vivo cytotoxic analysis (20.0 ml from a random patient) was collected for analysis at the Center for Modern Nanotechnologies of the Ural Federal University from the random naive patients to the BD Vacutainer (NJ, USA) plastic heparin tubes (spray-coated) with 150 USP units of sodium heparin per 10.0 ml, and then diluted by saline.
290942|NCT01270139|O1|Outcome|Exposure of Nanoparticles|Blood for ex-vivo cytotoxic analysis (20.0 ml from a random patient) was collected for analysis at the Center for Modern Nanotechnologies of the Ural Federal University from the random naive patients to the BD Vacutainer (NJ, USA) plastic heparin tubes (spray-coated) with 150 USP units of sodium heparin per 10.0 ml, and then diluted by 0.1 g/l silica-gold NPs.
291107|NCT01269125|O1|Outcome|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
291108|NCT01269125|O3|Outcome|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
290943|NCT01270139|O3|Outcome|Stenting Control|"In case of control group (stenting control), XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.~Stenting: 60 - in sirolimus-eluting stenting control"
290944|NCT01270139|O2|Outcome|Ferro Group|"60 patients in Ferro group were managed with transplantation of iron-bearing nanoparticles (NP), particularly with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction. NP were detonated with NIR laser under the protection of anti-platelet therapy.~Transplantation of iron-bearing nanoparticles: 60 - into ferro-magnetic group with 60/15-70/40 nm silica-gold iron-bearing NPs with delivery in hand of magnetic navigation system"
290945|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with transplantation of nanoparticles (NP), particularly with a bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. NP were activated with NIR laser at 7 days after the intervention. Transplantation of nanoparticles: 60 patients into nanogroup with the use of 60/15-70/40 nm silica-gold nanoparticles (NPs) transplanted by endoscopic cardiac surgery in the composition of bioengineered on-artery patch grown on the basis of biopolymeric scaffold and host circulating CD45-CD34-CD73+CD105+ progenitor cells
290946|NCT01270139|O3|Outcome|Stenting Control|"In case of control group (stenting control), XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.~Stenting: 60 - in sirolimus-eluting stenting control"
290947|NCT01270139|O2|Outcome|Ferro Group|"60 patients in Ferro group were managed with transplantation of iron-bearing nanoparticles (NP), particularly with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction. NP were detonated with NIR laser under the protection of anti-platelet therapy.~Transplantation of iron-bearing nanoparticles: 60 - into ferro-magnetic group with 60/15-70/40 nm silica-gold iron-bearing NPs with delivery in hand of magnetic navigation system"
290948|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with transplantation of nanoparticles (NP), particularly with a bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. NP were activated with NIR laser at 7 days after the intervention. Transplantation of nanoparticles: 60 patients into nanogroup with the use of 60/15-70/40 nm silica-gold nanoparticles (NPs) transplanted by endoscopic cardiac surgery in the composition of bioengineered on-artery patch grown on the basis of biopolymeric scaffold and host circulating CD45-CD34-CD73+CD105+ progenitor cells
290949|NCT01270139|O3|Outcome|Stenting Control|"In case of control group (stenting control), XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.~Stenting: 60 - in sirolimus-eluting stenting control"
291015|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
291016|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
291377|NCT01267227|P2|Participant Flow|Low Dose|Pterostilbene 50 mg twice daily
290950|NCT01270139|O2|Outcome|Ferro Group|"60 patients in Ferro group were managed with transplantation of iron-bearing nanoparticles (NP), particularly with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction. NP were detonated with NIR laser under the protection of anti-platelet therapy.~Transplantation of iron-bearing nanoparticles: 60 - into ferro-magnetic group with 60/15-70/40 nm silica-gold iron-bearing NPs with delivery in hand of magnetic navigation system"
290951|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with transplantation of nanoparticles (NP), particularly with a bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. NP were activated with NIR laser at 7 days after the intervention. Transplantation of nanoparticles: 60 patients into nanogroup with the use of 60/15-70/40 nm silica-gold nanoparticles (NPs) transplanted by endoscopic cardiac surgery in the composition of bioengineered on-artery patch grown on the basis of biopolymeric scaffold and host circulating CD45-CD34-CD73+CD105+ progenitor cells
290952|NCT01270139|O3|Outcome|Stenting Control|"In case of control group (stenting control), XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.~Stenting: 60 - in sirolimus-eluting stenting control"
290953|NCT01270139|O2|Outcome|Ferro Group|"60 patients in Ferro group were managed with transplantation of iron-bearing nanoparticles (NP), particularly with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction. NP were detonated with NIR laser under the protection of anti-platelet therapy.~Transplantation of iron-bearing nanoparticles: 60 - into ferro-magnetic group with 60/15-70/40 nm silica-gold iron-bearing NPs with delivery in hand of magnetic navigation system"
290954|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with transplantation of nanoparticles (NP), particularly with a bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. NP were activated with NIR laser at 7 days after the intervention. Transplantation of nanoparticles: 60 patients into nanogroup with the use of 60/15-70/40 nm silica-gold nanoparticles (NPs) transplanted by endoscopic cardiac surgery in the composition of bioengineered on-artery patch grown on the basis of biopolymeric scaffold and host circulating CD45-CD34-CD73+CD105+ progenitor cells
290955|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
290956|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
291017|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
291018|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
291109|NCT01269125|O2|Outcome|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
290957|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
290958|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
290959|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
290960|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
290961|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
290962|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
290963|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
291019|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
291020|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
291110|NCT01269125|O1|Outcome|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
329276|NCT01174446|O1|Outcome|All Study Participants|
290964|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
290965|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
290966|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
290967|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
290968|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
290969|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
290970|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
290985|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
290971|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
290972|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
290973|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
290974|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
290975|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
290976|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
290977|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
291010|NCT01269918|P1|Participant Flow|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
291011|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
291111|NCT01269125|O3|Outcome|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
290978|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
290979|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
290980|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
290981|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
290982|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
290983|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
290984|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
291012|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
291013|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
291014|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
290986|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
290987|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
290988|NCT01270139|O3|Outcome|Stenting Control|"In case of control group (stenting control), XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.~Stenting: 60 - in sirolimus-eluting stenting control"
290989|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with transplantation of iron-bearing nanoparticles (NP), particularly with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP. NP were detonated with NIR laser under the protection of anti-platelet therapy. Transplantation of iron-bearing nanoparticles: 60 - int
290990|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with transplantation of nanoparticles (NP), particularly with a bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation. Transplantation of nanoparticles: 60 patients into nanogroup with the use of 60/
290991|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
290992|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
290993|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
290994|NCT01270139|E3|Reported Event|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
290995|NCT01270139|E2|Reported Event|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
290996|NCT01270139|E1|Reported Event|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
290997|NCT01270126|B3|Baseline|Total|Total of all reporting groups
290998|NCT01270126|B2|Baseline|Sham Stimulation (Placebo Condition)|A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)
290999|NCT01270126|B1|Baseline|rtACS (Verum Condition)|"Repetitive transorbital alternating current stimulation (rtACS)~Repetitive transorbital alternating current stimulation : Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation."
291000|NCT01270126|P2|Participant Flow|Sham Stimulation (Placebo Condition)|A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)
291001|NCT01270126|P1|Participant Flow|rtACS (Verum Condition)|"Repetitive transorbital alternating current stimulation (rtACS)~Repetitive transorbital alternating current stimulation : Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation."
291002|NCT01270126|O2|Outcome|Sham Stimulation (Placebo Condition)|A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)
291003|NCT01270126|O1|Outcome|rtACS (Verum Condition)|"Repetitive transorbital alternating current stimulation (rtACS)~Repetitive transorbital alternating current stimulation : Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation."
291004|NCT01270126|E2|Reported Event|Sham Stimulation (Placebo Condition)|A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)
291005|NCT01270126|E1|Reported Event|rtACS (Verum Condition)|"Repetitive transorbital alternating current stimulation (rtACS)~Repetitive transorbital alternating current stimulation : Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation."
291006|NCT01269918|B3|Baseline|Total|Total of all reporting groups
291007|NCT01269918|B2|Baseline|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
291008|NCT01269918|B1|Baseline|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
291009|NCT01269918|P2|Participant Flow|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
291021|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
291022|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
291023|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
291024|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
291025|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
291026|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
291027|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
291028|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
291029|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
291030|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
291031|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
291032|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
291033|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
291034|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
291035|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
291036|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
291037|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
291038|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
291039|NCT01269918|E2|Reported Event|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
291040|NCT01269918|E1|Reported Event|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
291041|NCT01269801|B3|Baseline|Total|Total of all reporting groups
291042|NCT01269801|B2|Baseline|JUVÉDERM|"JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel~Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.~At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment."
291043|NCT01269801|B1|Baseline|Botox Cosmetic|"Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.~At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment."
291044|NCT01269801|P2|Participant Flow|Botox Cosmetic|"Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.~At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment."
291045|NCT01269801|P1|Participant Flow|JUVÉDERM|"JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel~Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.~At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment."
291046|NCT01269801|O2|Outcome|JUVÉDERM|"JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel~Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.~At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment."
291047|NCT01269801|O1|Outcome|Botox Cosmetic|"Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.~At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment."
291048|NCT01269801|E2|Reported Event|JUVÉDERM|"JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel~Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.~At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment."
291049|NCT01269801|E1|Reported Event|Botox Cosmetic|"Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.~At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment."
291050|NCT01269749|B3|Baseline|Total|Total of all reporting groups
291051|NCT01269749|B2|Baseline|ATD Group|"Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with antithyroid drugs (ATDs). In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).~ATD Group: Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with antithyroid drugs (ATDs). In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs)."
291052|NCT01269749|B1|Baseline|RAI Treatment|"Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with 131I. In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).~RAI treatment: Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with 131I. In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs)."
291053|NCT01269749|P2|Participant Flow|ATD Group|"Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with antithyroid drugs (ATDs). In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).~ATD Group: Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with antithyroid drugs (ATDs). In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs)."
291054|NCT01269749|P1|Participant Flow|RAI Treatment|"Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with 131I. In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).~RAI treatment: Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with 131I. In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs)."
291055|NCT01269749|O2|Outcome|ATD Group|"Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with antithyroid drugs (ATDs). In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).~ATD Group: Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with antithyroid drugs (ATDs). In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs)."
291069|NCT01269736|O1|Outcome|Online ECG Education|The intervention consisted of an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart.
291112|NCT01269125|O2|Outcome|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
291378|NCT01267227|P1|Participant Flow|High Dose|Pterostilbene 125 mg twice daily
291056|NCT01269749|O1|Outcome|RAI Treatment|"Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with 131I. In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).~RAI treatment: Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with 131I. In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs)."
291057|NCT01269749|O2|Outcome|ATD Group|"Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with antithyroid drugs (ATDs). In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).~ATD Group: Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with antithyroid drugs (ATDs). In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs)."
291058|NCT01269749|O1|Outcome|RAI Treatment|"Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with 131I. In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).~RAI treatment: Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with 131I. In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs)."
291059|NCT01269749|E2|Reported Event|ATD Group|"Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with antithyroid drugs (ATDs). In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).~ATD Group: Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with antithyroid drugs (ATDs). In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs)."
291060|NCT01269749|E1|Reported Event|RAI Treatment|"Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with 131I. In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).~RAI treatment: Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with 131I. In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs)."
291061|NCT01269736|B3|Baseline|Total|Total of all reporting groups
291062|NCT01269736|B2|Baseline|Patients|Patients on participating units on whom quality of care data was obtained.
291063|NCT01269736|B1|Baseline|Nurses|Nurses on participating units who received education at the time hospital assigned to the standard training or online ECG education training.
291064|NCT01269736|P2|Participant Flow|Standard Care Then Online ECG Monitoring|Hospitals were randomized to administer usual in-service education for nurses for 15 months, then received an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart.
291065|NCT01269736|P1|Participant Flow|Online ECG Education|The intervention consisted of an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart.
291066|NCT01269736|O2|Outcome|Standard Care Then Online ECG Monitoring|Hospitals were randomized to administer usual in-service education for nurses for 15 months, then received an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart.
291067|NCT01269736|O1|Outcome|Online ECG Education|The intervention consisted of an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart.
291068|NCT01269736|O2|Outcome|Standard Care Then Online ECG Monitoring|Hospitals were randomized to administer usual in-service education for nurses for 15 months, then received an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart.
291070|NCT01269736|O2|Outcome|Standard Care Then Online ECG Monitoring|Hospitals were randomized to administer usual in-service education for nurses for 15 months, then received an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart.
291071|NCT01269736|O1|Outcome|Online ECG Education|The intervention consisted of an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart.
291072|NCT01269736|E4|Reported Event|Standard Care Then Online ECG Monitoring- Quality of Care|Hospitals were randomized to administer usual in-service education for nurses for 15 months, then received an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart. Patient Quality of Care groups.
291073|NCT01269736|E3|Reported Event|Online ECG Education- Quality of Care|The intervention consisted of an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart. These are Adverse Events reported for the Patient Quality of Care groups.
291074|NCT01269736|E2|Reported Event|Standard Care Then Online ECG Monitoring- Patient Outcomes|Hospitals were randomized to administer usual in-service education for nurses for 15 months, then received an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart. These are Adverse Events reported for the Patient Outcomes groups.
291075|NCT01269736|E1|Reported Event|Online ECG Education- Patient Outcomes|The intervention consisted of an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart. These are Adverse Events reported for the Patient Outcomes groups.
291076|NCT01269710|B1|Baseline|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
291077|NCT01269710|P1|Participant Flow|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
291078|NCT01269710|O1|Outcome|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
291079|NCT01269710|O1|Outcome|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
291080|NCT01269710|O1|Outcome|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
291081|NCT01269710|O1|Outcome|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
291379|NCT01267227|O4|Outcome|Placebo|Matching placebo twice daily
291082|NCT01269710|O1|Outcome|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
291083|NCT01269710|E1|Reported Event|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
291084|NCT01269346|B1|Baseline|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.~Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
291085|NCT01269346|P1|Participant Flow|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.~Trastuzumab 8 mg/kg was administered as an IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
291086|NCT01269346|O1|Outcome|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.~Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
291087|NCT01269346|O1|Outcome|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.~Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
291088|NCT01269346|O1|Outcome|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.~Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
291089|NCT01269346|O1|Outcome|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.~Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
291090|NCT01269346|O1|Outcome|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.~Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
291091|NCT01269346|E1|Reported Event|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.~Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
291092|NCT01269125|B4|Baseline|Total|Total of all reporting groups
291093|NCT01269125|B3|Baseline|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
291094|NCT01269125|B2|Baseline|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
291095|NCT01269125|B1|Baseline|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
291096|NCT01269125|P3|Participant Flow|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
291097|NCT01269125|P2|Participant Flow|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
291098|NCT01269125|P1|Participant Flow|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
291099|NCT01269125|O3|Outcome|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
291100|NCT01269125|O2|Outcome|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
291101|NCT01269125|O1|Outcome|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
291102|NCT01269125|O3|Outcome|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
291103|NCT01269125|O2|Outcome|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
291104|NCT01269125|O1|Outcome|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
291105|NCT01269125|O3|Outcome|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
291106|NCT01269125|O2|Outcome|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
291380|NCT01267227|O3|Outcome|Low Dose Combination|Pterostilbene 50 mg/Grape Extract 100 mg twice daily
291113|NCT01269125|O1|Outcome|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
291114|NCT01269125|E3|Reported Event|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
291115|NCT01269125|E2|Reported Event|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
291116|NCT01269125|E1|Reported Event|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
291117|NCT01269047|B4|Baseline|Total|Total of all reporting groups
291118|NCT01269047|B3|Baseline|Insulin Monotherapy|"This group will be on their regular insulin therapy.~Insulin: Rapid acting and long acting, subcutaneously, according to their regimen for the entire duration of the study."
291119|NCT01269047|B2|Baseline|Exenatide + Insulin Group|"This group will get Exenatide(Byetta) along with insulin before breakfast and supper.~Exenatide: Start at 1.25 mcg, capped at 5 mcg, subcutaneously, before breakfast and supper for 4 months"
291120|NCT01269047|B1|Baseline|Pramlintide + Insulin Group|"These kids will get Pramlintide (Symlin) along with insulin before breakfast and supper.~Pramlintide: Start at 15 mcg capped at 60 mcg before breakfast and supper subcutaneously for 4 months"
291121|NCT01269047|P3|Participant Flow|Insulin Monotherapy|"This group will be on their regular insulin therapy.~Insulin: Rapid acting and long acting, subcutaneously, according to their regimen for the entire duration of the study."
291122|NCT01269047|P2|Participant Flow|Exenatide + Insulin Group|"This group will get Exenatide(Byetta) along with insulin before breakfast and supper.~Exenatide: Start at 1.25 mcg, capped at 5 mcg, subcutaneously, before breakfast and supper for 4 months"
291123|NCT01269047|P1|Participant Flow|Pramlintide + Insulin Group|"These kids will get Pramlintide (Symlin) along with insulin before breakfast and supper.~Pramlintide: Start at 15 mcg capped at 60 mcg before breakfast and supper subcutaneously for 4 months"
291124|NCT01269047|O5|Outcome|Insulin Monotherapy|These kids received insulin only treatment
291125|NCT01269047|O4|Outcome|Chronic Exenatide + Insulin Group|"This group will get Exenatide(Byetta) along with insulin before breakfast and supper.~Exenatide: Start at 1.25 mcg, capped at 5 mcg, subcutaneously, before breakfast and supper for 4 months"
291126|NCT01269047|O3|Outcome|Chronic Pramlintide + Insulin Group|"These kids will get Pramlintide (Symlin) along with insulin before breakfast and supper.~Pramlintide: Start at 15 mcg capped at 60 mcg before breakfast and supper subcutaneously for 4 months"
291127|NCT01269047|O2|Outcome|Acute Exenatide + Insulin Group|"The kids in Pramlintide group will get a single dose of Exenatide at the end of 4 months as part of the 4 hour MMTT.~The dose of pramlintide used for acute treatment is either 1.25 mcg or 2.5 mcg"
291128|NCT01269047|O1|Outcome|Acute Pramlintide + Insulin Group|"The kids in Exenatide group will get a single dose of Pramlintide at the end of 4 months as part of the 4 hour MMTT.~The dose of pramlintide used for acute treatment is either 30 mcg or 60 mcg"
291129|NCT01269047|O5|Outcome|Insulin Monotherapy|These kids received insulin only treatment
291130|NCT01269047|O4|Outcome|Chronic Exenatide + Insulin Group|"This group will get Exenatide(Byetta) along with insulin before breakfast and supper.~Exenatide: Start at 1.25 mcg, capped at 5 mcg, subcutaneously, before breakfast and supper for 4 months"
291131|NCT01269047|O3|Outcome|Chronic Pramlintide + Insulin Group|"These kids will get Pramlintide (Symlin) along with insulin before breakfast and supper.~Pramlintide: Start at 15 mcg capped at 60 mcg before breakfast and supper subcutaneously for 4 months"
291132|NCT01269047|O2|Outcome|Acute Exenatide + Insulin Group|"The kids in Pramlintide group will get a single dose of Exenatide at the end of 4 months as part of the 4 hour MMTT.~The dose of pramlintide used for acute treatment is either 1.25 mcg or 2.5 mcg"
291133|NCT01269047|O1|Outcome|Acute Pramlintide + Insulin Group|"The kids in Exenatide group will get a single dose of Pramlintide at the end of 4 months as part of the 4 hour MMTT.~The dose of pramlintide used for acute treatment is either 30 mcg or 60 mcg"
291134|NCT01269047|E3|Reported Event|Insulin Monotherapy|"This group will be on their regular insulin therapy.~Insulin: Rapid acting and long acting, subcutaneously, according to their regimen for the entire duration of the study."
291135|NCT01269047|E2|Reported Event|Exenatide + Insulin Group|"This group will get Exenatide(Byetta) along with insulin before breakfast and supper.~Exenatide: Start at 1.25 mcg, capped at 5 mcg, subcutaneously, before breakfast and supper for 4 months"
291136|NCT01269047|E1|Reported Event|Pramlintide + Insulin Group|"These kids will get Pramlintide (Symlin) along with insulin before breakfast and supper.~Pramlintide: Start at 15 mcg capped at 60 mcg before breakfast and supper subcutaneously for 4 months"
291137|NCT01268943|B5|Baseline|Total|Total of all reporting groups
291138|NCT01268943|B4|Baseline|1500mg|capecitabine 750mg/m2 twice daily. 6 patients enrolled
291139|NCT01268943|B3|Baseline|1400mg|capecitabine 700mg/m2 twice daily. 3 patients enrolled
291140|NCT01268943|B2|Baseline|1200mg|capecitabine 600mg/m2 twice daily. 3 patients enrolled
291141|NCT01268943|B1|Baseline|1000mg|capecitabine 500mg/m2 twice daily. 6 patients enrolled
291142|NCT01268943|P4|Participant Flow|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
291143|NCT01268943|P3|Participant Flow|1400mg|"capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
291144|NCT01268943|P2|Participant Flow|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
291145|NCT01268943|P1|Participant Flow|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
291146|NCT01268943|O4|Outcome|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
291381|NCT01267227|O2|Outcome|Low Dose|Pterostilbene 50 mg twice daily
291147|NCT01268943|O3|Outcome|1400mg|"capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
291148|NCT01268943|O2|Outcome|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
291149|NCT01268943|O1|Outcome|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
291150|NCT01268943|E4|Reported Event|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
291151|NCT01268943|E3|Reported Event|1400mg|"capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
291152|NCT01268943|E2|Reported Event|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
291153|NCT01268943|E1|Reported Event|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
291154|NCT01268891|B3|Baseline|Total|Total of all reporting groups
291155|NCT01268891|B2|Baseline|Azilect®|1 mg daily; tablet; orally; 18 weeks
291156|NCT01268891|B1|Baseline|Placebo|Once daily; tablet; orally; 18 weeks
291157|NCT01268891|P2|Participant Flow|Azilect®|1 mg daily; tablet; orally; 18 weeks
291158|NCT01268891|P1|Participant Flow|Placebo|Once daily; tablet; orally; 18 weeks
291159|NCT01268891|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 18 weeks
291160|NCT01268891|O1|Outcome|Placebo|Once daily; tablet; orally; 18 weeks
291161|NCT01268891|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 18 weeks
291162|NCT01268891|O1|Outcome|Placebo|Once daily; tablet; orally; 18 weeks
291163|NCT01268891|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 18 weeks
291164|NCT01268891|O1|Outcome|Placebo|Once daily; tablet; orally; 18 weeks
291165|NCT01268891|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 18 weeks
291166|NCT01268891|O1|Outcome|Placebo|Once daily; tablet; orally; 18 weeks
291167|NCT01268891|E2|Reported Event|Azilect®|
291168|NCT01268891|E1|Reported Event|Placebo|
291169|NCT01268683|B1|Baseline|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
291170|NCT01268683|P1|Participant Flow|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion; total of 3mg/day
291171|NCT01268683|O1|Outcome|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection): Bolus plus 72 hour IV infusion
291172|NCT01268683|O1|Outcome|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection): Bolus plus 72 hour IV infusion
291173|NCT01268683|O1|Outcome|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection): Bolus plus 72 hour IV infusion
291174|NCT01268683|O1|Outcome|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
291175|NCT01268683|E1|Reported Event|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
291176|NCT01268566|B1|Baseline|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
291177|NCT01268566|P1|Participant Flow|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
291178|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
291179|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
291180|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
291181|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
291182|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
291183|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
291184|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
291243|NCT01268189|E1|Reported Event|Study Dressing|"Oxygen diffusing dressing applied to wound~Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound"
291382|NCT01267227|O1|Outcome|High Dose|Pterostilbene 125 mg twice daily
291185|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
291186|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
291187|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
291188|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
291189|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
291190|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
291191|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
291192|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
291193|NCT01268566|E1|Reported Event|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
291194|NCT01268553|B1|Baseline|Open Label Single Arm Group|World Health Organization (WHO) group 1 PAH patients receiving long-term parenteral prostanoids
291195|NCT01268553|P1|Participant Flow|Open Label Single Arm Group|World Health Organization (WHO) group 1 PAH patients receiving long-term parenteral prostanoids
291196|NCT01268553|O1|Outcome|Open Label Single Arm Group|World Health Organization (WHO) group 1 PAH patients receiving long-term parenteral prostanoids
291197|NCT01268553|O1|Outcome|Open Label Single Arm Group|World Health Organization (WHO) group 1 PAH patients receiving long-term parenteral prostanoids
291198|NCT01268553|O1|Outcome|Open Label Single Arm Group|World Health Organization (WHO) group 1 PAH patients receiving long-term parenteral prostanoids
291199|NCT01268553|O1|Outcome|Open Label Single Arm Group|World Health Organization (WHO) group 1 PAH patients receiving long-term parenteral prostanoids
291200|NCT01268553|O1|Outcome|Open Label Single Arm Group|World Health Organization (WHO) group 1 PAH patients receiving long-term parenteral prostanoids
291201|NCT01268553|O1|Outcome|Open Label Single Arm Group|World Health Organization (WHO) group 1 PAH patients receiving long-term parenteral prostanoids
291202|NCT01268553|E1|Reported Event|Open Label Single Arm Group|World Health Organization (WHO) group 1 PAH patients receiving long-term parenteral prostanoids
291203|NCT01268501|B1|Baseline|Lotrafilcon B Multifocal|Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
291204|NCT01268501|P1|Participant Flow|Lotrafilcon B Multifocal|Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
291205|NCT01268501|O1|Outcome|Lotrafilcon B Multifocal|Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
291206|NCT01268501|E1|Reported Event|Lotrafilcon B Multifocal|Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
291207|NCT01268488|B1|Baseline|Intended Users of the System|"Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.~Ninja 2 Investigational Blood Glucose Meter : Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff."
291208|NCT01268488|P1|Participant Flow|Intended Users of the System|"Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.~Ninja 2 Investigational Blood Glucose Meter : Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff."
291209|NCT01268488|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.
291210|NCT01268488|O1|Outcome|Intended Users of the System|Ninja 2 Investigational Blood Glucose Meter : Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff.
291211|NCT01268488|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.
291244|NCT01268150|B1|Baseline|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
291212|NCT01268488|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.
291213|NCT01268488|E1|Reported Event|Intended Users of the System|"Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.~Ninja 2 Investigational Blood Glucose Meter : Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff."
291214|NCT01268306|B1|Baseline|Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses|Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
291215|NCT01268306|P1|Participant Flow|Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses|Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
291216|NCT01268306|O1|Outcome|Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses|Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
291217|NCT01268306|E1|Reported Event|Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses|Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
291218|NCT01268293|B1|Baseline|E7080|E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
291219|NCT01268293|P1|Participant Flow|E7080|E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
291220|NCT01268293|O1|Outcome|E7080|E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
291221|NCT01268293|O1|Outcome|E7080|E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
291222|NCT01268293|E1|Reported Event|E7080|E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
291223|NCT01268267|B1|Baseline|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
291224|NCT01268267|P1|Participant Flow|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.
291225|NCT01268267|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
291226|NCT01268267|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
291227|NCT01268267|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
291228|NCT01268267|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject were evaluated.
291229|NCT01268267|E1|Reported Event|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
291230|NCT01268189|B1|Baseline|Burn Wound Patients|Burn wound patients with oxygen diffusing dressing placed on 1 donor skin graft site and standard of care (Xeroform) dressing placed on a 2nd donor skin graft
291231|NCT01268189|P1|Participant Flow|Burn Wound Patients|Burn wound patients with experimental (oxyband) and control (Xeroform) dressings placed on 2 separate skin graft donor sites
291232|NCT01268189|O2|Outcome|Control Dressing|"Xeroform (current standard of care) dressing applied to wound~Control dressing: Xeroform control dressing applied to control wound"
291233|NCT01268189|O1|Outcome|Study Dressing|"Oxygen diffusing dressing applied to wound~Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound"
291234|NCT01268189|O2|Outcome|Control Dressing|"Xeroform (current standard of care) dressing applied to wound~Control dressing: Xeroform control dressing applied to control wound"
291235|NCT01268189|O1|Outcome|Study Dressing|"Oxygen diffusing dressing applied to wound~Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound"
291236|NCT01268189|O2|Outcome|Control Dressing|"Xeroform (current standard of care) dressing applied to wound~Control dressing: Xeroform control dressing applied to control wound"
291237|NCT01268189|O1|Outcome|Study Dressing|"Oxygen diffusing dressing applied to wound~Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound"
291238|NCT01268189|O2|Outcome|Control Dressing|"Xeroform (current standard of care) dressing applied to wound~Control dressing: Xeroform control dressing applied to control wound"
291239|NCT01268189|O1|Outcome|Study Dressing|"Oxygen diffusing dressing applied to wound~Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound"
291240|NCT01268189|O2|Outcome|Control Dressing|"Xeroform (current standard of care) dressing applied to wound~Control dressing: Xeroform control dressing applied to control wound"
291241|NCT01268189|O1|Outcome|Study Dressing|"Oxygen diffusing dressing applied to wound~Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound"
291242|NCT01268189|E2|Reported Event|Control Dressing|"Xeroform (current standard of care) dressing applied to wound~Control dressing: Xeroform control dressing applied to control wound"
291245|NCT01268150|P1|Participant Flow|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
291246|NCT01268150|O1|Outcome|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
291247|NCT01268150|O1|Outcome|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
291248|NCT01268150|O1|Outcome|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
291249|NCT01268150|O1|Outcome|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
291250|NCT01268150|O1|Outcome|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
291251|NCT01268150|E1|Reported Event|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
291252|NCT01268111|B3|Baseline|Total|Total of all reporting groups
291253|NCT01268111|B2|Baseline|Placebo|Matching placebo q weekly for 8 weeks
291254|NCT01268111|B1|Baseline|Vitamin D|ERgocalcifoerol 50,000 units q weekly for 8 weeks
291255|NCT01268111|P2|Participant Flow|Placebo|Matching placebo q weekly for 8 weeks
291256|NCT01268111|P1|Participant Flow|Vitamin D|ERgocalcifoerol 50,000 units q weekly for 8 weeks
291257|NCT01268111|O2|Outcome|Placebo|Matching placebo q weekly for 8 weeks
291258|NCT01268111|O1|Outcome|Vitamin D|ERgocalcifoerol 50,000 units q weekly for 8 weeks
291259|NCT01268111|E2|Reported Event|Placebo|Matching placebo q weekly for 8 weeks
291260|NCT01268111|E1|Reported Event|Vitamin D|ERgocalcifoerol 50,000 units q weekly for 8 weeks
291261|NCT01268098|B3|Baseline|Total|Total of all reporting groups
291262|NCT01268098|B2|Baseline|NPSP558 - 50 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily
291263|NCT01268098|B1|Baseline|NPSP558 - 25 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily
291264|NCT01268098|P2|Participant Flow|NPSP558 - 50 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily.
291265|NCT01268098|P1|Participant Flow|NPSP558 - 25 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily.
291266|NCT01268098|O2|Outcome|NPSP558 - 50 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily
291267|NCT01268098|O1|Outcome|NPSP558 - 25 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily
291268|NCT01268098|O2|Outcome|NPSP558 - 50 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily
291269|NCT01268098|O1|Outcome|NPSP558 - 25 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily
291270|NCT01268098|E2|Reported Event|NPSP558 - 50 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily
291271|NCT01268098|E1|Reported Event|NPSP558 - 25 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily
291272|NCT01267994|B1|Baseline|Single Arm|Patients with Autoimmune Inner Ear Disease that had <5dB hearing improvement in response to corticosteorids following 28 days of treatment
291273|NCT01267994|P1|Participant Flow|Open Label Trial|Open label, single arm trial of anakinra for corticosteroid-resistant Autoimmune Inner Ear Disease
291274|NCT01267994|O1|Outcome|Single Arm|Subject who received at least one injection of anakinra
291275|NCT01267994|O1|Outcome|Single Arm|Patients with Autoimmune Inner Ear Disease that had <5dB hearing improvement in response to corticosteorids following 28 days of treatment
291276|NCT01267994|E1|Reported Event|Single Arm|Anakinra administered for 84 consecutive days
291277|NCT01267929|B3|Baseline|Total|Total of all reporting groups
291278|NCT01267929|B2|Baseline|The Conventional Physical Therapy|The children receive manual physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. The conventional physical therapy technique in this study derive from the manual technique including the Bobath concept, stretching exercise and functional training for 30-45 minutes at a time.
291279|NCT01267929|B1|Baseline|The Mirror Neurons Stimulation Based VCD Program|The children receive the mirror neurons stimulation based Video Compact Disc (VCD) program and practice at home three times a day for six months. The mirror neurons stimulation based VCD program that contained four volumes. The first volume includes activities activities for improving balance in sitting position. The second volume includes activities of sitting to standing. The third volume includes activities for improving balance in standing position. The last one includes activities of sideway walking. The running time of each volume is 30 minutes. The children had been practicing for two weeks per volume. Their parents were trained for practicing their children by VCD program at home and were asked to complete daily record of children's activities. The children were scheduled to meet a pediatric physical therapist once a week to monitor possible side effects.
291280|NCT01267929|P2|Participant Flow|The Conventional Physical Therapy|The children receive manual physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. The conventional physical therapy technique in this study derive from the manual technique including the Bobath concept, stretching exercise and functional training for 30-45 minutes at a time.
291306|NCT01267292|B2|Baseline|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291383|NCT01267227|O4|Outcome|Placebo|Matching placebo twice daily. Unadjusted change from baseline.
291281|NCT01267929|P1|Participant Flow|The Mirror Neurons Stimulation Based VCD Program|The children receive the mirror neurons stimulation based Video Compact Disc (VCD) program and practice at home three times a day for six months. The mirror neurons stimulation based VCD program that contained four volumes. The first volume includes activities activities for improving balance in sitting position. The second volume includes activities of sitting to standing. The third volume includes activities for improving balance in standing position. The last one includes activities of sideway walking. The running time of each volume is 30 minutes. The children had been practicing for two weeks per volume. Their parents were trained for practicing their children by VCD program at home and were asked to complete daily record of children's activities. The children were scheduled to meet a pediatric physical therapist once a week to monitor possible side effects.
291282|NCT01267929|O2|Outcome|The Conventional Physical Therapy|The children receive manual physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. The conventional physical therapy technique in this study derive from the manual technique including the Bobath concept, stretching exercise and functional training for 30-45 minutes at a time.
291283|NCT01267929|O1|Outcome|The Mirror Neurons Stimulation Based VCD Program|The children receive the mirror neurons stimulation based Video Compact Disc (VCD) program and practice at home three times a day for six months. The mirror neurons stimulation based VCD program that contained four volumes. The first volume includes activities activities for improving balance in sitting position. The second volume includes activities of sitting to standing. The third volume includes activities for improving balance in standing position. The last one includes activities of sideway walking. The running time of each volume is 30 minutes. The children had been practicing for two weeks per volume. Their parents were trained for practicing their children by VCD program at home and were asked to complete daily record of children's activities. The children were scheduled to meet a pediatric physical therapist once a week to monitor possible side effects.
291284|NCT01267929|E2|Reported Event|The Conventional Physical Therapy|The children receive manual physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. The conventional physical therapy technique in this study derive from the manual technique including the Bobath concept, stretching exercise and functional training for 30-45 minutes at a time.
291285|NCT01267929|E1|Reported Event|The Mirror Neurons Stimulation Based VCD Program|The children receive the mirror neurons stimulation based Video Compact Disc (VCD) program and practice at home three times a day for six months. The mirror neurons stimulation based VCD program that contained four volumes. The first volume includes activities activities for improving balance in sitting position. The second volume includes activities of sitting to standing. The third volume includes activities for improving balance in standing position. The last one includes activities of sideway walking. The running time of each volume is 30 minutes. The children had been practicing for two weeks per volume. Their parents were trained for practicing their children by VCD program at home and were asked to complete daily record of children's activities. The children were scheduled to meet a pediatric physical therapist once a week to monitor possible side effects.
291286|NCT01267422|B1|Baseline|All Study Participants|Age,Gender,Ethnicity,Race,Region of Enrollment
291287|NCT01267422|P2|Participant Flow|Participants Receiving Treatment in Right Eye|4 participants receiving treatment in right eye
291288|NCT01267422|P1|Participant Flow|Participants Receiving Treatment in Left Eye|5 participants receiving treatment in left eye
291289|NCT01267422|O2|Outcome|Mean VFI After Treatment|Mean VFI after treatment of injected eyes;Mean VFI after treatment of uninjected eyes
291290|NCT01267422|O1|Outcome|Mean VFI Before Treatment|Mean VFI before treatment of injected eyes;Mean VFI before treatment of uninjected eyes
291291|NCT01267422|O2|Outcome|Mean MD After Treatment|Mean MD after treatment of injected eyes;Mean MD after treatment of uninjected eyes
291292|NCT01267422|O1|Outcome|Mean MD Before Treatment|Mean MD before treatment of injected eyes;Mean MD before treatment of uninjected eyes
291293|NCT01267422|O2|Outcome|Average RNFL Thickness After Treatment|Average RNFL thickness after treatment of injected eyes;Average RNFL thickness after treatment of uninjected eyes
291294|NCT01267422|O1|Outcome|Average RNFL Thickness Before Treatment|Average RNFL thickness before treatment of injected eyes;Average RNFL thickness before treatment of uninjected eyes
291295|NCT01267422|O2|Outcome|The Mean of Neutralizing Antibody Assay After Treatment|The mean of Neutralizing antibody assay after treatment of 8 patients
291296|NCT01267422|O1|Outcome|The Mean of Neutralizing Antibody Assay Before Treatment|The mean of Neutralizing antibody assay before treatment of 8 patients
291297|NCT01267422|O2|Outcome|IOP After Treatment|Ophthalmologic examinations includes IOP of 9 participants after treatment
291298|NCT01267422|O1|Outcome|IOP Before Treatment|Ophthalmologic examinations includes IOP of 9 paticipants before treatment
291299|NCT01267422|O2|Outcome|The Mean Percentage of CD3+/CD4+/CD8+ After Treatment|The mean percentage of CD3+ after treatment;The mean percentage of CD4+ after treatment;The mean percentage of CD8+ after treatment
291300|NCT01267422|O1|Outcome|The Mean Percentage of CD3+/CD4+/CD8+ Before Treatment|The mean percentage of CD3+ before treatment;The mean percentage of CD4+ before treatment;The mean percentage of CD8+ before treatment
291301|NCT01267422|O2|Outcome|BCVA of Treated Eyes|BCVA of trearted eyes in 9 patients
291302|NCT01267422|O1|Outcome|BCVA of Un-treated Eyes|BCVA of un-treated eyes in 9 patients
291303|NCT01267422|E2|Reported Event|Long-term Affects|Lens may be injured after intravitreal injection, and cataract is probably complicated. Retinal detachment or endophthalmitis may be complicated due to retina injury.IOP raised.Blood and urine routine is affected.Liver and kidney function is affected.Immune response after surgery.
291304|NCT01267422|E1|Reported Event|Short-term Affects|Lens may be injured during intravitreal injection, and cataract is probably complicated. Retinal detachment or endophthalmitis may be complicated due to retina injury.IOP raised.Endophthalmitis after treament. Hyper-susceptibility or immune response during surgery or after surgery.
291305|NCT01267292|B3|Baseline|Total|Total of all reporting groups
291367|NCT01267240|O1|Outcome|Arm I (Capecitabine, Vorinostat)|"Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Vorinostat: Given PO"
291384|NCT01267227|O3|Outcome|Low Dose Combination|Pterostilbene 50 mg/Grape Extract 100 mg twice daily. Unadjusted change from baseline.
291307|NCT01267292|B1|Baseline|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291308|NCT01267292|P2|Participant Flow|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291309|NCT01267292|P1|Participant Flow|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291310|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291311|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291312|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291313|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291314|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291315|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291316|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291368|NCT01267240|O1|Outcome|Arm I (Capecitabine, Vorinostat)|"Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Vorinostat: Given PO"
291385|NCT01267227|O2|Outcome|Low Dose|Pterostilbene 50 mg twice daily. Unadjusted change from baseline.
291317|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291318|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291319|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291320|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291321|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291322|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291323|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291324|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291325|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291326|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291369|NCT01267240|E1|Reported Event|Arm I (Capecitabine, Vorinostat)|"Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Vorinostat: Given PO"
291370|NCT01267227|B5|Baseline|Total|Total of all reporting groups
291371|NCT01267227|B4|Baseline|Placebo|Matching placebo twice daily
291327|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291328|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291329|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291330|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291331|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291332|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291333|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291334|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291335|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291336|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291372|NCT01267227|B3|Baseline|Low Dose Combination|Pterostilbene 50 mg/Grape Extract 100 mg twice daily
291373|NCT01267227|B2|Baseline|Low Dose|Pterostilbene 50 mg twice daily
291374|NCT01267227|B1|Baseline|High Dose|Pterostilbene 125 mg twice daily
291375|NCT01267227|P4|Participant Flow|Placebo|Matching placebo twice daily
291337|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291338|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291339|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
291340|NCT01267292|E2|Reported Event|Placebo|"week 1: Placebo BID weeks 2-3: Placebo BID~Placebo: week 1 = placebo BID weeks 2-3 = placebo BID"
291341|NCT01267292|E1|Reported Event|Buspirone|"week 1: Buspirone 30 mg BID weeks 2-3: Buspirone 45 mg BID~Buspirone: week 1 = 30 mg BID weeks 2-3 = 45 mg BID"
291342|NCT01267266|B1|Baseline|Arm I (Saracatinib)|Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
291343|NCT01267266|P2|Participant Flow|Arm II (Placebo)|Patients receive oral placebo once daily on days 1-28.
291344|NCT01267266|P1|Participant Flow|Arm I (Saracatinib)|Patients receive 175 mg oral saracatinib once daily on days 1-28.
291345|NCT01267266|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo once daily on days 1-28.
291346|NCT01267266|O1|Outcome|Arm I (Saracatinib)|Patients receive 175 mg oral saracatinib once daily on days 1-28.
291347|NCT01267266|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo once daily on days 1-28.
291348|NCT01267266|O1|Outcome|Arm I (Saracatinib)|Patients receive 175 mg oral saracatinib once daily on days 1-28.
291349|NCT01267266|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo once daily on days 1-28.
291350|NCT01267266|O1|Outcome|Arm I (Saracatinib)|Patients receive 175 mg oral saracatinib once daily on days 1-28.
291351|NCT01267266|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Upon progression, patients may crossover to arm I.~hydrocortisone/placebo: Given orally"
291352|NCT01267266|O1|Outcome|Arm I (Saracatinib)|"Patients receive oral saracatinib once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
291353|NCT01267266|E3|Reported Event|Placebo, Randomized Phase|Patients receive placebo once daily on days 1-28.
291354|NCT01267266|E2|Reported Event|Saracatinib, Randomized Phase|Patients receive 175 mg oral saracatinib once daily on days 1-28.
291355|NCT01267266|E1|Reported Event|Saracatinib, Lead-in Phase|Patients receive 175 mg oral saracatinib once daily on days 1-28.
291356|NCT01267253|B1|Baseline|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
291357|NCT01267253|P1|Participant Flow|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
291358|NCT01267253|O1|Outcome|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
291359|NCT01267253|O1|Outcome|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
291360|NCT01267253|O1|Outcome|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
291361|NCT01267253|O1|Outcome|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
291362|NCT01267253|O1|Outcome|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
291363|NCT01267253|E1|Reported Event|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
291364|NCT01267240|B1|Baseline|Arm I (Capecitabine, Vorinostat)|"Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Vorinostat: Given PO"
291365|NCT01267240|P1|Participant Flow|Arm I (Capecitabine, Vorinostat)|"Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Vorinostat: Given PO"
291366|NCT01267240|O1|Outcome|Arm I (Capecitabine, Vorinostat)|"Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Vorinostat: Given PO"
291376|NCT01267227|P3|Participant Flow|Low Dose Combination|Pterostilbene 50 mg/Grape Extract 100 mg twice daily
291386|NCT01267227|O1|Outcome|High Dose|Pterostilbene 125 mg twice daily. Unadjusted change from baseline.
291387|NCT01267227|O4|Outcome|Placebo|Matching placebo twice daily. Unadjusted change from baseline.
291388|NCT01267227|O3|Outcome|Low Dose Combination|Pterostilbene 50 mg/Grape Extract 100 mg twice daily. Unadjusted change from baseline.
291389|NCT01267227|O2|Outcome|Low Dose|Pterostilbene 50 mg twice daily. Unadjusted change from baseline.
291390|NCT01267227|O1|Outcome|High Dose|Pterostilbene 125 mg twice daily. Unadjusted change from baseline.
291391|NCT01267227|E4|Reported Event|Placebo|Matching placebo twice daily
291392|NCT01267227|E3|Reported Event|Low Dose Combination|Pterostilbene 50 mg/Grape Extract 100 mg twice daily
291393|NCT01267227|E2|Reported Event|Low Dose|Pterostilbene 50 mg twice daily
291394|NCT01267227|E1|Reported Event|High Dose|Pterostilbene 125 mg twice daily
291395|NCT01267201|B1|Baseline|Entire Study Population|Includes all participants randomized to receive methylprednisolone 32 mg tablet first, formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) first and formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) first.
291396|NCT01267201|P6|Participant Flow|Methylprednisolone Formulation 2, Formulation 1, 32 mg Tablet|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in first intervention period; followed by single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in second intervention period; and single oral dose of methylprednisolone 32 mg tablet on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
291397|NCT01267201|P5|Participant Flow|Methylprednisolone Formulation 2, 32 mg Tablet, Formulation 1|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in first intervention period; followed by single oral dose of methylprednisolone 32 mg tablet on Day 1 in second intervention period; and single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
291398|NCT01267201|P4|Participant Flow|Methylprednisolone Formulation 1, Formulation 2, 32 mg Tablet|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in first intervention period; followed by single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in second intervention period; and single oral dose of methylprednisolone 32 mg tablet on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
291399|NCT01267201|P3|Participant Flow|Methylprednisolone Formulation 1, 32 mg Tablet, Formulation 2|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in first intervention period; followed by single oral dose of methylprednisolone 32 mg tablet on Day 1 in second intervention period; and single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
291400|NCT01267201|P2|Participant Flow|Methylprednisolone 32 mg Tablet, Formulation 2, Formulation 1|Single oral dose of methylprednisolone 32 mg tablet on Day 1 in first intervention period; followed by single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in second intervention period; and single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
291401|NCT01267201|P1|Participant Flow|Methylprednisolone 32 mg Tablet, Formulation 1, Formulation 2|Single oral dose of methylprednisolone 32 milligram (mg) tablet on Day 1 in first intervention period; followed by single dose of formulation 1: methylprednisolone oral suspension 4 milligram/milliliter (mg/mL) at 32 mg (Micronized active pharmaceutical ingredient [API]) on Day 1 in second intervention period; and single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
291402|NCT01267201|O3|Outcome|Methylprednisolone 32 mg Sieve Cut API|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 of any of the three intervention periods.
291403|NCT01267201|O2|Outcome|Methylprednisolone 32 mg Micronized API|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 of any of the three intervention periods.
291404|NCT01267201|O1|Outcome|Methylprednisolone 32 mg Tablet|Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
291405|NCT01267201|O3|Outcome|Methylprednisolone 32 mg Sieve Cut API|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 of any of the three intervention periods.
291406|NCT01267201|O2|Outcome|Methylprednisolone 32 mg Micronized API|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 of any of the three intervention periods.
291407|NCT01267201|O1|Outcome|Methylprednisolone 32 mg Tablet|Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
291408|NCT01267201|O3|Outcome|Methylprednisolone 32 mg Sieve Cut API|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 of any of the three intervention periods.
291409|NCT01267201|O2|Outcome|Methylprednisolone 32 mg Micronized API|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 of any of the three intervention periods.
291410|NCT01267201|O1|Outcome|Methylprednisolone 32 mg Tablet|Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
291411|NCT01267201|O3|Outcome|Methylprednisolone 32 mg Sieve Cut API|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 of any of the three intervention periods.
291412|NCT01267201|O2|Outcome|Methylprednisolone 32 mg Micronized API|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 of any of the three intervention periods.
291413|NCT01267201|O1|Outcome|Methylprednisolone 32 mg Tablet|Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
292016|NCT01265615|B4|Baseline|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
291414|NCT01267201|E3|Reported Event|Methylprednisolone 32 mg Sieve Cut API|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 of any of the three intervention periods.
291415|NCT01267201|E2|Reported Event|Methylprednisolone 32 mg Micronized API|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 of any of the three intervention periods.
291416|NCT01267201|E1|Reported Event|Methylprednisolone 32 mg Tablet|Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
291417|NCT01267175|B1|Baseline|X54 Pump|All subjects transferred from current pump to X54
291418|NCT01267175|P1|Participant Flow|X54 Pump|All subjects transferred from current pump to X54
291419|NCT01267175|O1|Outcome|X54 Pump|All subjects transferred from current pump to X54
291420|NCT01267175|O1|Outcome|X54 Pump|All subjects transferred from current pump to X54
291421|NCT01267175|E1|Reported Event|X54 Pump|All subjects transferred from current pump to X54
291422|NCT01267136|B3|Baseline|Total|Total of all reporting groups
291423|NCT01267136|B2|Baseline|Tramadol Suspension|Tramadol suspension : Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
291424|NCT01267136|B1|Baseline|Capital® With Codeine Suspension|Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
291425|NCT01267136|P2|Participant Flow|Tramadol Suspension|Tramadol suspension : Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h pro re nata (PRN) (max. of 3 PRN doses/day).
291426|NCT01267136|P1|Participant Flow|Capital® With Codeine Suspension|Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h pro re nata (PRN) (max. of 3 PRN doses/day)
291427|NCT01267136|O2|Outcome|Tramadol Suspension|Tramadol suspension: Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
291428|NCT01267136|O1|Outcome|Capital® With Codeine Suspension|Codeine with acetaminophen: Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
291429|NCT01267136|O2|Outcome|Tramadol Suspension|Tramadol suspension : Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
291430|NCT01267136|O1|Outcome|Capital® With Codeine Suspension|Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
291431|NCT01267136|E2|Reported Event|Tramadol Suspension|Tramadol suspension : Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
291432|NCT01267136|E1|Reported Event|Capital® With Codeine Suspension|Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
291433|NCT01267045|B3|Baseline|Total|Total of all reporting groups
291434|NCT01267045|B2|Baseline|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
291435|NCT01267045|B1|Baseline|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in Mindfulness-Based Stress Reduction.~Mindfulness-based stress reduction: A common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
291436|NCT01267045|P2|Participant Flow|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
291437|NCT01267045|P1|Participant Flow|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction.~Mindfulness-based stress reduction: A common clinical method of teaching mindfulness is a class series called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
291438|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
291439|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
291440|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
291441|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
291442|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
291443|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
291444|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
291445|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
291446|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
291447|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
291448|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
291449|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
291450|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
291451|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
291452|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
291492|NCT01266967|O2|Outcome|ThxID BRAF Mutation Positive Participants|Melanoma participants determined to be positive for the BRAF V600E and V600K mutations as determined by the ThxID assay. The RGI test was further validated by BioMerieux (BMX THxID assay) for regulatory approval. The THxID IUO assay was used to retrospectively confirm the RGI test results.
291493|NCT01266967|O1|Outcome|RGI IUO Mutation Positive Participants|Melanoma participants determined to be positive for the BRAF V600E and V600K mutations as determined by the RGI assay. The RGI assay is a BRAF mutation test developed by Response Genetics Incorporated, and was used to determine eligibility. It employs the allele-specific polymerase chain reaction (ASPCR) methodology, and was offered as an Investigational Use Only assay (only for pre-market investigational purposes).
291453|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
291454|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
291455|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
291456|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
291457|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
291458|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
291459|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
291460|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
291461|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
291462|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
291463|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can b"
291464|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
291494|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291495|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291496|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291465|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
291466|NCT01267045|E2|Reported Event|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
291467|NCT01267045|E1|Reported Event|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course.~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can b"
291468|NCT01267019|B4|Baseline|Total|Total of all reporting groups
291469|NCT01267019|B3|Baseline|Arm 3: Non-social Skills|"non-social skills training~non-social skills training: 30 sessions of skills training that has no specific social content"
291470|NCT01267019|B2|Baseline|Arm 2: Social Cognitive|"social cognitive training~social cognitive training: 30 sessions of social cognitive training without in vivo exercises"
291471|NCT01267019|B1|Baseline|Arm 1: Vivo Augmentation|"social cognitive training with in vivo augmentation~social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises"
291472|NCT01267019|P3|Participant Flow|Arm 3: Non-social Skills|"non-social skills training~non-social skills training: 30 sessions of skills training that has no specific social content"
291473|NCT01267019|P2|Participant Flow|Arm 2: Social Cognitive|"social cognitive training~social cognitive training: 30 sessions of social cognitive training without in vivo exercises"
291474|NCT01267019|P1|Participant Flow|Arm 1: Vivo Augmentation|"social cognitive training with in vivo augmentation~social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises"
291475|NCT01267019|O3|Outcome|Arm 3: Non-social Skills|"non-social skills training~non-social skills training: 30 sessions of skills training that has no specific social content"
291476|NCT01267019|O2|Outcome|Arm 2: Social Cognitive|"social cognitive training~social cognitive training: 30 sessions of social cognitive training without in vivo exercises"
291477|NCT01267019|O1|Outcome|Arm 1: Vivo Augmentation|"social cognitive training with in vivo augmentation~social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises"
291478|NCT01267019|O3|Outcome|Arm 3: Non-social Skills|"non-social skills training~non-social skills training: 30 sessions of skills training that has no specific social content"
291479|NCT01267019|O2|Outcome|Arm 2: Social Cognitive|"social cognitive training~social cognitive training: 30 sessions of social cognitive training without in vivo exercises"
291480|NCT01267019|O1|Outcome|Arm 1: Vivo Augmentation|"social cognitive training with in vivo augmentation~social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises"
291481|NCT01267019|O3|Outcome|Arm 3: Non-social Skills|"non-social skills training~non-social skills training: 30 sessions of skills training that has no specific social content"
291482|NCT01267019|O2|Outcome|Arm 2: Social Cognitive|"social cognitive training~social cognitive training: 30 sessions of social cognitive training without in vivo exercises"
291483|NCT01267019|O1|Outcome|Arm 1: Vivo Augmentation|"social cognitive training with in vivo augmentation~social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises"
291484|NCT01267019|E3|Reported Event|Arm 3: Non-social Skills|"non-social skills training~non-social skills training: 30 sessions of skills training that has no specific social content"
291485|NCT01267019|E2|Reported Event|Arm 2: Social Cognitive|"social cognitive training~social cognitive training: 30 sessions of social cognitive training without in vivo exercises"
291486|NCT01267019|E1|Reported Event|Arm 1: Vivo Augmentation|"social cognitive training with in vivo augmentation~social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises"
291487|NCT01266967|B3|Baseline|Total|Total of all reporting groups
291488|NCT01266967|B2|Baseline|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291489|NCT01266967|B1|Baseline|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 milligram (mg) capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291490|NCT01266967|P2|Participant Flow|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291491|NCT01266967|P1|Participant Flow|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 milligram (mg) capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291548|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291497|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291498|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291499|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291500|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291501|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291502|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291503|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291504|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291505|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291506|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291507|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291508|NCT01266967|O1|Outcome|GSK2118436 150 mg|Participants with or without prior local therapy for brain metastasis received GSK2118436 50 mg and 75 mg capsules either one hour before or 2 hours after a meal twice daily.
291509|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291510|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291511|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291512|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291513|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291514|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291515|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291516|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291517|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291518|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291519|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291549|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
292232|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
291520|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291521|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291522|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291523|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291524|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291525|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291526|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291527|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291528|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291529|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291530|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291531|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291532|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291533|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291534|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291535|NCT01266967|E2|Reported Event|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291536|NCT01266967|E1|Reported Event|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
291537|NCT01266876|B6|Baseline|Total|Total of all reporting groups
291538|NCT01266876|B5|Baseline|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291539|NCT01266876|B4|Baseline|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291540|NCT01266876|B3|Baseline|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291541|NCT01266876|B2|Baseline|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291542|NCT01266876|B1|Baseline|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291543|NCT01266876|P5|Participant Flow|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291544|NCT01266876|P4|Participant Flow|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291545|NCT01266876|P3|Participant Flow|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291546|NCT01266876|P2|Participant Flow|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection once every 4 weeks (Q4W) added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291547|NCT01266876|P1|Participant Flow|Placebo|Placebo subcutaneous (SC) injection once every two weeks (Q2W) added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
292018|NCT01265615|B2|Baseline|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
291550|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291551|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291552|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291553|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291554|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291555|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291556|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291557|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291558|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291559|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291560|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291561|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291562|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291563|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291564|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291565|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291566|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291567|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291568|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291569|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291570|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291571|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291572|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291573|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291574|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291575|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291576|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291577|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291578|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291579|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291580|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291581|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291582|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291583|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291584|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291585|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291586|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291587|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291588|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291589|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291590|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291591|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
329277|NCT01174446|O1|Outcome|All Study Participants|
291592|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291593|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291594|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291595|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291596|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291597|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291598|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291599|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291600|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291601|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291602|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291603|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291604|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291605|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291606|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291607|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291608|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291609|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291610|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291611|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291612|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291613|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291614|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291615|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291616|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291617|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291618|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291619|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291620|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291621|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291622|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291623|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291624|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291625|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291626|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291627|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291628|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291629|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291630|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291631|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291632|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291633|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
292019|NCT01265615|B1|Baseline|Paricalcitol Treatment|6-8 μg daily per os without special diet
291634|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291635|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291636|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291637|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291638|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291639|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291640|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291641|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291642|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291643|NCT01266876|E5|Reported Event|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291644|NCT01266876|E4|Reported Event|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291645|NCT01266876|E3|Reported Event|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291646|NCT01266876|E2|Reported Event|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291647|NCT01266876|E1|Reported Event|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
291648|NCT01266850|B6|Baseline|Total|Total of all reporting groups
291649|NCT01266850|B5|Baseline|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received 2-mL Rotarix® orally at 2 months of age, followed by 1-mL RotaTeq® orally at 4 and 6 months of age.
291650|NCT01266850|B4|Baseline|Group 4: Rotarix, Rotarix|Participants received 2-mL Rotarix® orally at 2 and 4 months of age.
291651|NCT01266850|B3|Baseline|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received 2-mL RotaTeq® orally at 2 and 4 months of age, followed by 1-mL Rotarix® orally at 6 months of age.
291652|NCT01266850|B2|Baseline|Group 2: RotaTeq, Rotarix, Rotarix|Participants received 2-mL RotaTeq® orally at 2 months of age, followed by 1-mL Rotarix® orally at 4 and 6 months of age.
291653|NCT01266850|B1|Baseline|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received 2-mL RotaTeq® orally at 2, 4 and 6 months of age.
291654|NCT01266850|P5|Participant Flow|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
291655|NCT01266850|P4|Participant Flow|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
291656|NCT01266850|P3|Participant Flow|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
291657|NCT01266850|P2|Participant Flow|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
291658|NCT01266850|P1|Participant Flow|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
291659|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
291660|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
291661|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
291662|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
291663|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
291664|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
291665|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
291666|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
291667|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
291668|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
291669|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
291670|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
291671|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
291672|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
291673|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
291674|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
291675|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
291676|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
291677|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
291678|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
291679|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
291680|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
291681|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
291682|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
291683|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
291684|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
291685|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
291686|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
291687|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
291688|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
291689|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
291690|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
291691|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
291692|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
291693|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
291694|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
291695|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
291696|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
291697|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
291698|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
291699|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
291700|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
291701|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
291702|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
291703|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
291704|NCT01266850|E5|Reported Event|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
291705|NCT01266850|E4|Reported Event|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
291706|NCT01266850|E3|Reported Event|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
291707|NCT01266850|E2|Reported Event|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
291708|NCT01266850|E1|Reported Event|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
291709|NCT01266824|B3|Baseline|Total|Total of all reporting groups
291710|NCT01266824|B2|Baseline|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
291711|NCT01266824|B1|Baseline|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops~Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
291712|NCT01266824|P2|Participant Flow|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
291713|NCT01266824|P1|Participant Flow|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops~Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
291714|NCT01266824|O2|Outcome|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
291715|NCT01266824|O1|Outcome|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops~Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
291716|NCT01266824|O2|Outcome|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
291717|NCT01266824|O1|Outcome|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops~Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
291718|NCT01266824|O2|Outcome|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
291719|NCT01266824|O1|Outcome|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops~Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
291720|NCT01266824|O2|Outcome|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
291721|NCT01266824|O1|Outcome|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops~Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
291722|NCT01266824|E2|Reported Event|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
291723|NCT01266824|E1|Reported Event|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops~Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
291724|NCT01266447|B1|Baseline|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
291725|NCT01266447|P1|Participant Flow|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
291726|NCT01266447|O1|Outcome|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
291727|NCT01266447|O1|Outcome|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
291728|NCT01266447|O1|Outcome|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
291729|NCT01266447|O1|Outcome|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
291730|NCT01266447|O1|Outcome|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
291731|NCT01266447|O1|Outcome|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
291732|NCT01266447|E1|Reported Event|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
291733|NCT01266317|B1|Baseline|Combined PEX, Rituximab and Steroids|"Standard Steroid Treatment: One gm of methylprednisolone I.V., on day 0, followed by 40 mg/day I.V. on days 1-4, and days 6-12 (or the P.O. prednisone equivalent). Methylprednisolone 100 mg I.V. will be administered on days 5 and 13. Steroid doses will then be 20 mg methylprednisolone I.V. (or P.O. prednisone equivalent) from days 14-28, and then reduced thereafter at the discretion of the principle investigator.~Plasma exchange (PEX) will consist of 1.5x estimated plasma volume exchanges for 3 successive days (0, 1,2) and then, after a one day interval to enable equilibration of autoantibodies sequestered in tissues, two more daily treatments on days 4 and 5.~Rituximab: One gm I.V. will be administered on day 5 (after completion of the last PEX) and day 13.~Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids: Standard Steroid Treatment, Plasma exchange will consist of 1.5x estimated plasma volume exchanges, Rituximab"
291734|NCT01266317|P1|Participant Flow|Combined PEX, Rituximab and Steroids|"Standard Steroid Treatment: One gm of methylprednisolone I.V., on day 0, followed by 40 mg/day I.V. on days 1-4, and days 6-12 (or the P.O. prednisone equivalent). Methylprednisolone 100 mg I.V. will be administered on days 5 and 13. Steroid doses will then be 20 mg methylprednisolone I.V. (or P.O. prednisone equivalent) from days 14-28, and then reduced thereafter at the discretion of the principle investigator.~Plasma exchange (PEX) will consist of 1.5x estimated plasma volume exchanges for 3 successive days (0, 1,2) and then, after a one day interval to enable equilibration of autoantibodies sequestered in tissues, two more daily treatments on days 4 and 5.~Rituximab: One gm I.V. will be administered on day 5 (after completion of the last PEX) and day 13.~Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids: Standard Steroid Treatment, Plasma exchange will consist of 1.5x estimated plasma volume exchanges, Rituximab"
292017|NCT01265615|B3|Baseline|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
291735|NCT01266317|O1|Outcome|Combined PEX, Rituximab and Steroids|"Standard Steroid Treatment: One gm of methylprednisolone I.V., on day 0, followed by 40 mg/day I.V. on days 1-4, and days 6-12 (or the P.O. prednisone equivalent). Methylprednisolone 100 mg I.V. will be administered on days 5 and 13. Steroid doses will then be 20 mg methylprednisolone I.V. (or P.O. prednisone equivalent) from days 14-28, and then reduced thereafter at the discretion of the principle investigator.~Plasma exchange (PEX) will consist of 1.5x estimated plasma volume exchanges for 3 successive days (0, 1,2) and then, after a one day interval to enable equilibration of autoantibodies sequestered in tissues, two more daily treatments on days 4 and 5.~Rituximab: One gm I.V. will be administered on day 5 (after completion of the last PEX) and day 13.~Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids: Standard Steroid Treatment, Plasma exchange will consist of 1.5x estimated plasma volume exchanges, Rituximab"
291736|NCT01266317|O1|Outcome|Combined PEX, Rituximab and Steroids|"Standard Steroid Treatment: One gm of methylprednisolone I.V., on day 0, followed by 40 mg/day I.V. on days 1-4, and days 6-12 (or the P.O. prednisone equivalent). Methylprednisolone 100 mg I.V. will be administered on days 5 and 13. Steroid doses will then be 20 mg methylprednisolone I.V. (or P.O. prednisone equivalent) from days 14-28, and then reduced thereafter at the discretion of the principle investigator.~Plasma exchange (PEX) will consist of 1.5x estimated plasma volume exchanges for 3 successive days (0, 1,2) and then, after a one day interval to enable equilibration of autoantibodies sequestered in tissues, two more daily treatments on days 4 and 5.~Rituximab: One gm I.V. will be administered on day 5 (after completion of the last PEX) and day 13.~Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids: Standard Steroid Treatment, Plasma exchange will consist of 1.5x estimated plasma volume exchanges, Rituximab"
291737|NCT01266317|E1|Reported Event|Combined PEX, Rituximab and Steroids|"Standard Steroid Treatment: One gm of methylprednisolone I.V., on day 0, followed by 40 mg/day I.V. on days 1-4, and days 6-12 (or the P.O. prednisone equivalent). Methylprednisolone 100 mg I.V. will be administered on days 5 and 13. Steroid doses will then be 20 mg methylprednisolone I.V. (or P.O. prednisone equivalent) from days 14-28, and then reduced thereafter at the discretion of the principle investigator.~Plasma exchange (PEX) will consist of 1.5x estimated plasma volume exchanges for 3 successive days (0, 1,2) and then, after a one day interval to enable equilibration of autoantibodies sequestered in tissues, two more daily treatments on days 4 and 5.~Rituximab: One gm I.V. will be administered on day 5 (after completion of the last PEX) and day 13.~Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids: Standard Steroid Treatment, Plasma exchange will consist of 1.5x estimated plasma volume exchanges, Rituximab"
291738|NCT01266291|B1|Baseline|Treatment With Sabril (Vigabatrin)|This is a single arm study. All subjects who are eligible for treatment will begin taking vigabatrin (Sabril) during the third month of the study. Treatment will be in accordance with the FDA-approved prescribing information: upward titration will happen at a rate of 500mg per week until subjects reach their maximum tolerated dose, or 3g per day (whichever is lower). This dose may be decreased if needed under the supervision of the study doctor. Subjects who need to lower their dose or who stop taking Sabril will have their dosage decreased by 1 gm/week for one month under the supervision of the study doctor.
291739|NCT01266291|P1|Participant Flow|Treatment With Sabril (Vigabatrin)|"The interventional arm of this phase 4 study involved subjects taking vigabatrin (Sabril) in accordance with standard of care, FDA approved dosing instructions. There were no planned arms; all subjects followed the FDA-approved prescribing label.~As there were not multiple treatment arms under investigation, per the FDA-approved prescribing label, the one and only subject who enrolled underwent upward titration happened at a rate of 500mg per week until she reached her maximum tolerated dose, or 3g per day. This dose was decreased as needed under the supervision of the study doctor. Again in accordance with standard of care, FDA-approved prescribing guidelines, when she stopped taking Sabril, her dosage decreased at a rate of 1 gm/week for one month under the supervision of the study doctor."
291740|NCT01266291|O1|Outcome|Treatment With Sabril (Vigabatrin)|This is a single arm study. All subjects who are eligible for treatment will begin taking vigabatrin (Sabril) during the third month of the study. Treatment will be in accordance with the FDA-approved prescribing information: upward titration will happen at a rate of 500mg per week until subjects reach their maximum tolerated dose, or 3g per day (whichever is lower). This dose may be decreased if needed under the supervision of the study doctor. Subjects who need to lower their dose or who stop taking Sabril will have their dosage decreased at a rate of 1 gm/week for one month under the supervision of the study doctor.
291741|NCT01266291|O1|Outcome|Treatment With Sabril (Vigabatrin)|This is a single arm study. All subjects who are eligible for treatment will begin taking vigabatrin (Sabril) during the third month of the study. Treatment will be in accordance with the FDA-approved prescribing information: upward titration will happen at a rate of 500mg per week until subjects reach their maximum tolerated dose, or 3g per day (whichever is lower). This dose may be decreased if needed under the supervision of the study doctor. Subjects who need to lower their dose or who stop taking Sabril will have their dosage decreased at a rate of 1 gm/week for one month under the supervision of the study doctor.
291742|NCT01266291|E1|Reported Event|Treatment With Sabril (Vigabatrin)|This is a single arm study. All subjects who are eligible for treatment will begin taking vigabatrin (Sabril) during the third month of the study. Treatment will be in accordance with the FDA-approved prescribing information: upward titration will happen at a rate of 500mg per week until subjects reach their maximum tolerated dose, or 3g per day (whichever is lower). This dose may be decreased if needed under the supervision of the study doctor. Subjects who need to lower their dose or who stop taking Sabril will have their dosage decreased at a rate of 1 gm/week for one month under the supervision of the study doctor.
291743|NCT01266265|B3|Baseline|Total|Total of all reporting groups
291744|NCT01266265|B2|Baseline|Control|The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
291745|NCT01266265|B1|Baseline|Tyvaso|"The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.~inhaled prostacyclin: Tyvaso"
291746|NCT01266265|P2|Participant Flow|Control|"The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of Baseline visit, but treated with any other FDA approved PAH therapy as part of routine care.~inhaled prostacyclin: As prescribed by the physician prostacyclin: As prescribed by the physician subcutaneous and intravenous prostacyclin: As prescribed by physician oral ERA: As prescribed by physician oral PDE5 inhibitors: As prescribed by physician"
291747|NCT01266265|P1|Participant Flow|Tyvaso|"The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.~inhaled prostacyclin: Tyvaso"
291748|NCT01266265|O2|Outcome|Control|The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
291749|NCT01266265|O1|Outcome|Tyvaso|"The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.~inhaled prostacyclin: Tyvaso"
291750|NCT01266265|E2|Reported Event|Control|The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
291751|NCT01266265|E1|Reported Event|Tyvaso|"The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.~inhaled prostacyclin: Tyvaso"
291752|NCT01266148|B3|Baseline|Total|Total of all reporting groups
291753|NCT01266148|B2|Baseline|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
291754|NCT01266148|B1|Baseline|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
291755|NCT01266148|P2|Participant Flow|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
291756|NCT01266148|P1|Participant Flow|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
291757|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
291758|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
291759|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
291760|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
291761|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
291762|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
291763|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
291764|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
291765|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
291766|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
291767|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
291768|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
291769|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
291770|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
291771|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
291772|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
291773|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
291774|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
291775|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
291776|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
291777|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
291778|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
291779|NCT01266148|E2|Reported Event|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
291780|NCT01266148|E1|Reported Event|Controls|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study
291781|NCT01266122|B3|Baseline|Total|Total of all reporting groups
291782|NCT01266122|B2|Baseline|Behavioral Intervention|"Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India.~Behavioral intervention: The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk."
291783|NCT01266122|B1|Baseline|HIV/STI Voluntary Counseling and Testing|Participants enrolled in the control arm will receive study assessments only.
291784|NCT01266122|P2|Participant Flow|Behavioral Intervention|"Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India.~Behavioral intervention: The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk."
291785|NCT01266122|P1|Participant Flow|HIV/STI Voluntary Counseling and Testing|Participants enrolled in the control arm will receive study assessments only.
291786|NCT01266122|O2|Outcome|Behavioral Intervention|"Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India.~Behavioral intervention: The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk."
291787|NCT01266122|O1|Outcome|HIV/STI Voluntary Counseling and Testing|Participants enrolled in the control arm will receive study assessments only.
291788|NCT01266122|O2|Outcome|Behavioral Intervention|"Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India.~Behavioral intervention: The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk."
291789|NCT01266122|O1|Outcome|HIV/STI Voluntary Counseling and Testing|Participants enrolled in the control arm will receive study assessments only.
291790|NCT01266122|E2|Reported Event|Behavioral Intervention|"Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India.~Behavioral intervention: The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk."
291791|NCT01266122|E1|Reported Event|HIV/STI Voluntary Counseling and Testing|Participants enrolled in the control arm will receive study assessments only.
291792|NCT01266070|B1|Baseline|Dovitinib|Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
291793|NCT01266070|P1|Participant Flow|Dovitinib|Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
291794|NCT01266070|O1|Outcome|Dovitinib|Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
291795|NCT01266070|O1|Outcome|Dovitinib|Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
291796|NCT01266070|E1|Reported Event|Dovitinib|Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
291797|NCT01266031|B4|Baseline|Total|Total of all reporting groups
291798|NCT01266031|B3|Baseline|Bevacizumab + Vorinostat 400 mg|Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
291799|NCT01266031|B2|Baseline|Bevacizumab|Phase II Bevacizumab 10 mg/kg/dose by vein on days 1 and 15 of a 28 day cycle.
291800|NCT01266031|B1|Baseline|Vorinostat + Bevacizumab|Phase I Vorinostat starting dose 400 mg orally days 1 - 7 and days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 + 15 of 28 day cycle.
291801|NCT01266031|P3|Participant Flow|Bevacizumab + Vorinostat 400 mg|Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
291802|NCT01266031|P2|Participant Flow|Bevacizumab|Phase II Bevacizumab 10 mg/kg/dose IV on days 1 & 15 of a 28 day cycle.
291803|NCT01266031|P1|Participant Flow|Vorinostat + Bevacizumab|Phase I Vorinostat starting dose 400 mg orally days 1 - 7 & days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 & 15 of 28 day cycle.
291804|NCT01266031|O1|Outcome|Vorinostat + Bevacizumab|Phase I Vorinostat starting dose 400 mg orally days 1 - 7 & days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 & 15 of 28 day cycle.
291805|NCT01266031|O2|Outcome|Bevacizumab + Vorinostat 400 mg|Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
291806|NCT01266031|O1|Outcome|Bevacizumab|Phase II Bevacizumab 10 mg/kg/dose IV on days 1 & 15 of a 28 day cycle.
291807|NCT01266031|E3|Reported Event|Phase II: Bevacizumab + Vorinostat 400 mg|Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
291808|NCT01266031|E2|Reported Event|Phase II: Bevacizumab|Phase II Bevacizumab 10 mg/kg/dose IV on days 1 & 15 of a 28 day cycle.
291809|NCT01266031|E1|Reported Event|Phase I: Vorinostat + Bevacizumab|Phase I Vorinostat starting dose 400 mg orally days 1 - 7 & days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 & 15 of 28 day cycle.
291810|NCT01266018|B1|Baseline|All Enrolled Subjects|Includes all subjects enrolled in Cohort 1 (n = 9) and Cohort 2 (n = 13).
291811|NCT01266018|P2|Participant Flow|Cohort 2: Refractory Disease|Cohort 2 comprised subjects with “refractory” disease, defined as subjects who either (a) were treated with 1 previous line of chemotherapy and either had no response or progressed < 90 days after completing treatment or (b) required third-line therapy, i.e., had completed 2 previous lines of chemotherapy, regardless of response
291812|NCT01266018|P1|Participant Flow|Cohort 1: Sensitive Disease|Cohort 1 comprised subjects with “sensitive” disease, defined as subjects who were treated with 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more.
291813|NCT01266018|O2|Outcome|Cohort 2: Refractory Disease|Includes subjects with “refractory” disease, defined as subjects who either (a) were treated with 1 previous line of chemotherapy and either had no response or progressed < 90 days after completing treatment or (b) required third-line therapy, i.e., had completed 2 previous lines of chemotherapy, regardless of response.
291814|NCT01266018|O1|Outcome|Cohort 1: Sensitive Disease|Includes subjects with “sensitive” disease, defined as subjects who were treated with 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more.
291815|NCT01266018|O1|Outcome|All Subjects (Pharmacodynamic Analysis Set)|Includes all subjects in Cohort 1 (n = 9) and Cohort 2 (n = 12) who received at least 1 dose of study drug and provided plasma samples for pharmacodynamic analyses.
291816|NCT01266018|O1|Outcome|All Subjects (Pharmacodynamic Analysis Set)|Includes all subjects in Cohort 1 (n = 9) and Cohort 2 (n = 12) who received at least 1 dose of study drug and provided plasma samples for pharmacodynamic analyses.
291817|NCT01266018|O2|Outcome|Cohort 2: Refractory Disease|"Includes subjects with refractory disease, defined as subjects who either (a) were treated with 1 previous line of chemotherapy and either had no response or progressed < 90 days after completing treatment or (b) required third-line therapy, i.e., had completed 2 previous lines of chemotherapy, regardless of response."
291818|NCT01266018|O1|Outcome|Cohort 1: Sensitive Disease|"Includes subjects with sensitive disease, defined as subjects who were treated with 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more."
291819|NCT01266018|O2|Outcome|Cohort 2: Refractory Disease|Includes subjects with “refractory” disease, defined as subjects who either (a) were treated with 1 previous line of chemotherapy and either had no response or progressed < 90 days after completing treatment or (b) required third-line therapy, i.e., had completed 2 previous lines of chemotherapy, regardless of response.
291820|NCT01266018|O1|Outcome|Cohort 1: Sensitive Disease|Includes subjects with “sensitive” disease, defined as subjects who were treated with 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more.
291821|NCT01266018|E1|Reported Event|All Subjects (Safety Analysis Set)|Includes all subjects in Cohort 1 (n = 9) and Cohort 2 (n = 13) who received at least 1 dose of study drug.
291822|NCT01265992|B1|Baseline|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
291823|NCT01265992|P1|Participant Flow|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 chronic kidney disease (CKD) and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
291824|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
291825|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
291826|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
291827|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
291828|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
291829|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
291830|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
291831|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
291832|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
291833|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
291834|NCT01265992|E1|Reported Event|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
291835|NCT01265966|B4|Baseline|Total|Total of all reporting groups
291836|NCT01265966|B3|Baseline|General Anesthesia|Children undergoing general anesthesia for procedures.
291837|NCT01265966|B2|Baseline|Deep Sedation|Children undergoing deep sedation for procedures.
291838|NCT01265966|B1|Baseline|Moderate Sedation|Children undergoing moderate sedation for procedures.
291839|NCT01265966|P3|Participant Flow|General Anesthesia|Children undergoing general anesthesia for procedures.
291840|NCT01265966|P2|Participant Flow|Deep Sedation|Children undergoing deep sedation for procedures.
291841|NCT01265966|P1|Participant Flow|Moderate Sedation|Children undergoing moderate sedation for procedures.
291842|NCT01265966|O3|Outcome|General Anesthesia|Children undergoing general anesthesia for procedures.
291843|NCT01265966|O2|Outcome|Deep Sedation|Children undergoing deep sedation for procedures.
291844|NCT01265966|O1|Outcome|Moderate Sedation|Children undergoing moderate sedation for procedures.
291845|NCT01265966|E3|Reported Event|General Anesthesia|Children undergoing general anesthesia for procedures.
291846|NCT01265966|E2|Reported Event|Deep Sedation|Children undergoing deep sedation for procedures.
291847|NCT01265966|E1|Reported Event|Moderate Sedation|Children undergoing moderate sedation for procedures.
291848|NCT01265953|B3|Baseline|Total|Total of all reporting groups
291849|NCT01265953|B2|Baseline|Placebo Capsules|"Four weeks placebo capsules: 8 capsules (4 capsules B.I.D.) daily~Gelatin capsule containing cellulose and magnesium stearate: Four weeks placebo: 8 capsules (4 capsules B.I.D.) daily"
291885|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
292233|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
291850|NCT01265953|B1|Baseline|Sulforaphane Glucosinolate Capsules|"Four weeks sulforaphane (SFN) glucosinolate capsules: 250 mg of broccoli seed extract (30 mg sulforaphane glucosinolate), 8 capsules (4 capsules B.I.D.) daily~sulforaphane glucosinolate capsules: Four weeks sulforaphane (SFN) glucosinolate capsules: 250 mg of broccoli seed extract (30 mg sulforaphane glucosinolate), 8 capsules (4 capsules B.I.D.) daily"
291851|NCT01265953|P2|Participant Flow|Placebo|Subjects in this group were administered with placebo.
291852|NCT01265953|P1|Participant Flow|Supplement|Subjects in this group were administered with broccoli sprout extract.
291853|NCT01265953|O2|Outcome|Placebo|Subjects in this group were administered with placebo.
291854|NCT01265953|O1|Outcome|Supplement|Subjects in this group were administered with broccoli sprout extract.
291855|NCT01265953|O2|Outcome|Placebo|Subjects in this group were administered with placebo.
291856|NCT01265953|O1|Outcome|Supplement|Subjects in this group were administered with broccoli sprout extract.
291857|NCT01265953|O2|Outcome|Placebo|Subjects in this group were administered with placebo.
291858|NCT01265953|O1|Outcome|Supplement|Subjects in this group were administered with broccoli sprout extract.
291859|NCT01265953|O2|Outcome|Placebo|Subjects in this group were administered with placebo.
291860|NCT01265953|O1|Outcome|Supplement|Subjects in this group were administered with broccoli sprout extract.
291861|NCT01265953|E2|Reported Event|Placebo|Subjects in this group were administered with placebo.
291862|NCT01265953|E1|Reported Event|Supplement|Subjects in this group were administered with broccoli sprout extract.
291863|NCT01265875|B1|Baseline|Human Secretin|Human Secretin : Dose Escalation
291864|NCT01265875|P1|Participant Flow|Human Secretin|"Human Secretin : Dose Escalation~There were 3 days of dosing, 3 doses per day. This was a dose escalation within the participant and did not exceed 0.8mcg/kg, which is within safe limits."
291865|NCT01265875|O1|Outcome|Human Secretin|"Human Secretin : Dose Escalation~There were 3 days of dosing, 3 doses per day. This was a dose escalation within the participant and did not exceed 0.8mcg/kg, which is within safe limits."
291866|NCT01265875|O1|Outcome|Human Secretin|"Human Secretin : Dose Escalation~There were 3 days of dosing, 3 doses per day. This was a dose escalation within the participant and did not exceed 0.8mcg/kg, which is within safe limits."
291867|NCT01265875|O1|Outcome|Human Secretin|"Human Secretin : Dose Escalation~There were 3 days of dosing, 3 doses per day. This was a dose escalation within the participant and did not exceed 0.8mcg/kg, which is within safe limits."
291868|NCT01265875|O1|Outcome|Human Secretin|"Human Secretin : Dose Escalation~There were 3 days of dosing, 3 doses per day. This was a dose escalation within the participant and did not exceed 0.8mcg/kg, which is within safe limits."
291869|NCT01265875|O1|Outcome|Human Secretin|Human Secretin : Dose Escalation
291870|NCT01265875|E1|Reported Event|Human Secretin|Human Secretin : Dose Escalation within participant
291871|NCT01265823|B1|Baseline|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
291872|NCT01265823|P1|Participant Flow|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
291873|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
291874|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
291875|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
291876|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
291877|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
291878|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
291879|NCT01265823|O2|Outcome|Adalimumab in Non-obese Participants|Non-obese participants were defined as those with a waist-hip ratio of ≤1 for men and ≤0.8 for women. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
291880|NCT01265823|O1|Outcome|Adalimumab in Obese Participants|Obese participants were defined as those with a waist-hip ratio of >1 for men and >0.8 for women. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
291881|NCT01265823|O2|Outcome|Adalimumab in Non-obese Participants|Non-obese participants were defined as having a BMI < 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
291882|NCT01265823|O1|Outcome|Adalimumab in Obese Participants|Obese participants were defined as having a BMI ≥ 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
291883|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
291884|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
292004|NCT01265667|P1|Participant Flow|CF101 2 mg|CF101: orally q12h
291886|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
291887|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
291888|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
291889|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
291890|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
291891|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
291892|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
291893|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
291894|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
291895|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
291896|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
291897|NCT01265823|E1|Reported Event|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
291898|NCT01265797|B3|Baseline|Total|Total of all reporting groups
291899|NCT01265797|B2|Baseline|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
291900|NCT01265797|B1|Baseline|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
291901|NCT01265797|P2|Participant Flow|Sham|Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days
291902|NCT01265797|P1|Participant Flow|Verum|Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days
291903|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
291904|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
291905|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
291906|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
291907|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
291908|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
291909|NCT01265797|O2|Outcome|Sham|Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days
291910|NCT01265797|O1|Outcome|Verum|Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days
291911|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
291912|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
291913|NCT01265797|O2|Outcome|Sham|Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days
291914|NCT01265797|O1|Outcome|Verum|Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days
291915|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
291916|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
291917|NCT01265797|O2|Outcome|Sham|Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days
291918|NCT01265797|O1|Outcome|Verum|Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days
291919|NCT01265797|O2|Outcome|Sham|Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days
291920|NCT01265797|O1|Outcome|Verum|Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days
291921|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
291922|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
291923|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
291924|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
291925|NCT01265797|O2|Outcome|Sham|Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days
291926|NCT01265797|O1|Outcome|Verum|Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days
291927|NCT01265797|E2|Reported Event|Sham|Sham: wears sham cranial electrostimulation (CES) device for 20 minutes daily for 28 days
291928|NCT01265797|E1|Reported Event|Verum|Verum : wears active cranial electrostimulation (CES) device for 20 minutes daily for 28 days
291929|NCT01265784|B4|Baseline|Total|Total of all reporting groups
291930|NCT01265784|B3|Baseline|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291931|NCT01265784|B2|Baseline|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291932|NCT01265784|B1|Baseline|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291933|NCT01265784|P3|Participant Flow|Ertapenem, 1 g q24h|Ertapenem was administered IV at a dose of 1 gram (g) q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291934|NCT01265784|P2|Participant Flow|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg every 12 hours (q12h) for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291935|NCT01265784|P1|Participant Flow|TP-434, 1.5 mg/kg q24h|TP-434 was administered intravenously (IV) at a dose of 1.5 milligrams per kilogram of body weight (mg/kg) every 24 hours (q24h) for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291936|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291937|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291938|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291939|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291940|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291941|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291942|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291943|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291944|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291945|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291946|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291947|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291948|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291949|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291950|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291951|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291952|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291953|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291954|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291955|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291956|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291957|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291958|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291959|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291960|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291961|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291962|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291963|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291964|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291965|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
292005|NCT01265667|O2|Outcome|Placebo|Placebo: orally q12h
291966|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291967|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291968|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291969|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291970|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291971|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291972|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291973|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291974|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291975|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291976|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291977|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291978|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291979|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291980|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291981|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291982|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291983|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291984|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291985|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291986|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291987|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291988|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291989|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291990|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291991|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291992|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291993|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291994|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291995|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291996|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291997|NCT01265784|E3|Reported Event|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291998|NCT01265784|E2|Reported Event|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
291999|NCT01265784|E1|Reported Event|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
292000|NCT01265667|B3|Baseline|Total|Total of all reporting groups
292001|NCT01265667|B2|Baseline|Placebo|Oral tablets given every 12 hours for 16 weeks
292002|NCT01265667|B1|Baseline|CF101 2mg|Oral tablets given every 12 hours for 16 weeks
292003|NCT01265667|P2|Participant Flow|Placebo|Placebo: orally q12h
292020|NCT01265615|P4|Participant Flow|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
292021|NCT01265615|P3|Participant Flow|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
292022|NCT01265615|P2|Participant Flow|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
292023|NCT01265615|P1|Participant Flow|Paricalcitol Treatment|6-8 μg daily per os without special diet
292024|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
292025|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
292026|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
292027|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
292028|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
292029|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
292030|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
292031|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
292032|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
292033|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
292034|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
292035|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
292036|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
292037|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
292038|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
292039|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
292040|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
292041|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
292042|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
292043|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
292044|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
292045|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
292046|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
292047|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
292048|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
292049|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
292050|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
292051|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
292052|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
292053|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
292054|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
292055|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
292056|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
292057|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
292058|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
292059|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
292060|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
292061|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
292062|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
292063|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
292064|NCT01265615|E4|Reported Event|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
292065|NCT01265615|E3|Reported Event|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
292066|NCT01265615|E2|Reported Event|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
292067|NCT01265615|E1|Reported Event|Paricalcitol Treatment|6-8 μg daily per os without special diet
292068|NCT01265563|B6|Baseline|Total|Total of all reporting groups
292069|NCT01265563|B5|Baseline|NAC Active and High-dose Silibin Active|"N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos~N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
292234|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292070|NCT01265563|B4|Baseline|NAC Active and Silibin Active|"N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months~(Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months~(Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months"
292071|NCT01265563|B3|Baseline|NAC Placebo and Silibin Active|"N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months~(Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo~(Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months"
292072|NCT01265563|B2|Baseline|NAC Active and Silibin Placebo|"N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
292073|NCT01265563|B1|Baseline|NAC Placebo and Silibin Placebo|"N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months"
292074|NCT01265563|P5|Participant Flow|NAC Active + High Dose Silibin Active|"N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos~N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
292075|NCT01265563|P4|Participant Flow|NAC Active + Silibin Active|"N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months~(Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months~(Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months"
292076|NCT01265563|P3|Participant Flow|NAC Placebo + Silibin Active|"N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months~(Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo~(Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months"
292077|NCT01265563|P2|Participant Flow|NAC Active + Silibin Placebo|"N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
292078|NCT01265563|P1|Participant Flow|NAC Placebo + Silibin Placebo|"N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months"
292079|NCT01265563|O5|Outcome|NAC Active + High-dose Silibin Active|"N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos~N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
292080|NCT01265563|O4|Outcome|NAC Active + Silibin Active|"N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months~(Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months~(Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months"
292116|NCT01265550|O3|Outcome|Placebo Medical Treatment Group|"Omeprazole + placebo~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292081|NCT01265563|O3|Outcome|NAC Placebo + Silibin Active|"N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months~(Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo~(Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months"
292082|NCT01265563|O2|Outcome|NAC Active + Silibin Placebo|"N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
292083|NCT01265563|O1|Outcome|NAC Placebo + Silibin Placebo|"N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months"
292084|NCT01265563|O5|Outcome|NAC Active + High-dose Silibin Active|"N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos~N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
292085|NCT01265563|O4|Outcome|NAC Active + Silibin Active|"N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months~(Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months~(Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months"
292086|NCT01265563|O3|Outcome|NAC Placebo + Silibin Active|"N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months~(Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo~(Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months"
292087|NCT01265563|O2|Outcome|NAC Active + Silibin Placebo|"N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
292088|NCT01265563|O1|Outcome|NAC Placebo + Silibin Placebo|"N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months"
292089|NCT01265563|E5|Reported Event|NAC Active + High-dose Silibin Active|"N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos~N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
292090|NCT01265563|E4|Reported Event|NAC Active + Silibin Active|"N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months~(Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months~(Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months"
292091|NCT01265563|E3|Reported Event|NAC Placebo + Silibin Active|"N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months~(Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo~(Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months"
292092|NCT01265563|E2|Reported Event|NAC Active + Silibin Placebo|"N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
292117|NCT01265550|O2|Outcome|Surgical Treatment Group|"Laparoscopic nissen fundoplications~Nissen fundoplication: laparoscopic antireflux surgery"
292093|NCT01265563|E1|Reported Event|NAC Placebo + Silibin Placebo|"N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months"
292094|NCT01265550|B4|Baseline|Total|Total of all reporting groups
292095|NCT01265550|B3|Baseline|Placebo Medical Treatment Group|"baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292096|NCT01265550|B2|Baseline|Surgical Treatment Group|Nissen fundoplication: laparoscopic antireflux surgery
292097|NCT01265550|B1|Baseline|Medical Treatment Group|"baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292098|NCT01265550|P3|Participant Flow|Placebo Medical Treatment Group|"baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292099|NCT01265550|P2|Participant Flow|Surgical Treatment Group|Nissen fundoplication: laparoscopic antireflux surgery
292100|NCT01265550|P1|Participant Flow|Medical Treatment Group|"baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292101|NCT01265550|O3|Outcome|Placebo Medical Treatment Group|"Omeprazole + placebo~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292102|NCT01265550|O2|Outcome|Surgical Treatment Group|"Laparoscopic nissen fundoplications~Nissen fundoplication: laparoscopic antireflux surgery"
292103|NCT01265550|O1|Outcome|Medical Treatment Group|"Omeprazole + baclofen or Omeprazole + desipramine~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292104|NCT01265550|O3|Outcome|Placebo Medical Treatment Group|"Omeprazole + placebo~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292105|NCT01265550|O2|Outcome|Surgical Treatment Group|"Laparoscopic nissen fundoplications~Nissen fundoplication: laparoscopic antireflux surgery"
292106|NCT01265550|O1|Outcome|Medical Treatment Group|"Omeprazole + baclofen or Omeprazole + desipramine~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292107|NCT01265550|O3|Outcome|Placebo Medical Treatment Group|"Omeprazole + placebo~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292108|NCT01265550|O2|Outcome|Surgical Treatment Group|"Laparoscopic nissen fundoplications~Nissen fundoplication: laparoscopic antireflux surgery"
292109|NCT01265550|O1|Outcome|Medical Treatment Group|"Omeprazole + baclofen or Omeprazole + desipramine~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292110|NCT01265550|O3|Outcome|Placebo Medical Treatment Group|"Omeprazole + placebo~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292111|NCT01265550|O2|Outcome|Surgical Treatment Group|"Laparoscopic nissen fundoplications~Nissen fundoplication: laparoscopic antireflux surgery"
292112|NCT01265550|O1|Outcome|Medical Treatment Group|"Omeprazole + baclofen or Omeprazole + desipramine~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292113|NCT01265550|O3|Outcome|Placebo Medical Treatment Group|"Omeprazole + placebo~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292114|NCT01265550|O2|Outcome|Surgical Treatment Group|"Laparoscopic nissen fundoplications~Nissen fundoplication: laparoscopic antireflux surgery"
292115|NCT01265550|O1|Outcome|Medical Treatment Group|"Omeprazole + baclofen or Omeprazole + desipramine~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292118|NCT01265550|O1|Outcome|Medical Treatment Group|"Omeprazole + baclofen or Omeprazole + desipramine~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292119|NCT01265550|O3|Outcome|Placebo Medical Treatment Group|"Omeprazole + placebo~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292120|NCT01265550|O2|Outcome|Surgical Treatment Group|"Laparoscopic nissen fundoplications~Nissen fundoplication: laparoscopic antireflux surgery"
292121|NCT01265550|O1|Outcome|Medical Treatment Group|"Omeprazole + baclofen or Omeprazole + desipramine~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292122|NCT01265550|O3|Outcome|Placebo Medical Treatment Group|"Omeprazole + placebo~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292123|NCT01265550|O2|Outcome|Surgical Treatment Group|"Laparoscopic nissen fundoplications~Nissen fundoplication: laparoscopic antireflux surgery"
292124|NCT01265550|O1|Outcome|Medical Treatment Group|"Omeprazole + baclofen or Omeprazole + desipramine~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292125|NCT01265550|O3|Outcome|Placebo Medical Treatment Group|"Omeprazole + placebo~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292126|NCT01265550|O2|Outcome|Surgical Treatment Group|"Laparoscopic nissen fundoplications~Nissen fundoplication: laparoscopic antireflux surgery"
292127|NCT01265550|O1|Outcome|Medical Treatment Group|"Omeprazole + baclofen or Omeprazole + desipramine~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292128|NCT01265550|O3|Outcome|Placebo Medical Treatment Group|"Omeprazole + placebo~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292129|NCT01265550|O2|Outcome|Surgical Treatment Group|"Laparoscopic nissen fundoplications~Nissen fundoplication: laparoscopic antireflux surgery"
292130|NCT01265550|O1|Outcome|Medical Treatment Group|"Omeprazole + baclofen or Omeprazole + desipramine~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292131|NCT01265550|O3|Outcome|Placebo Medical Treatment Group|"Omeprazole + placebo~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292132|NCT01265550|O2|Outcome|Surgical Treatment Group|"Laparoscopic nissen fundoplications~Nissen fundoplication: laparoscopic antireflux surgery"
292133|NCT01265550|O1|Outcome|Medical Treatment Group|"Omeprazole + baclofen or Omeprazole + desipramine~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292134|NCT01265550|O3|Outcome|Placebo Medical Treatment Group|"Omeprazole + placebo~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292135|NCT01265550|O2|Outcome|Surgical Treatment Group|"Laparoscopic nissen fundoplications~Nissen fundoplication: laparoscopic antireflux surgery"
292136|NCT01265550|O1|Outcome|Medical Treatment Group|"Omeprazole + baclofen or Omeprazole + desipramine~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292137|NCT01265550|O3|Outcome|Placebo Medical Treatment Group|"Omeprazole + placebo~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292138|NCT01265550|O2|Outcome|Surgical Treatment Group|"Laparoscopic nissen fundoplications~Nissen fundoplication: laparoscopic antireflux surgery"
292139|NCT01265550|O1|Outcome|Medical Treatment Group|"Omeprazole + baclofen or Omeprazole + desipramine~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292140|NCT01265550|O3|Outcome|Placebo Medical Treatment Group|"Omeprazole + placebo~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292141|NCT01265550|O2|Outcome|Surgical Treatment Group|"Laparoscopic nissen fundoplications~Nissen fundoplication: laparoscopic antireflux surgery"
292142|NCT01265550|O1|Outcome|Medical Treatment Group|"Omeprazole + baclofen or Omeprazole + desipramine~baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292143|NCT01265550|O3|Outcome|Placebo Medical Treatment Group|"baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292144|NCT01265550|O2|Outcome|Surgical Treatment Group|Nissen fundoplication: laparoscopic antireflux surgery
292145|NCT01265550|O1|Outcome|Medical Treatment Group|"baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292146|NCT01265550|E3|Reported Event|Placebo Medical Treatment Group|"baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292147|NCT01265550|E2|Reported Event|Surgical Treatment Group|Nissen fundoplication: laparoscopic antireflux surgery
292148|NCT01265550|E1|Reported Event|Medical Treatment Group|"baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.~Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit."
292149|NCT01265524|B3|Baseline|Total|Total of all reporting groups
292150|NCT01265524|B2|Baseline|Placebo|Placebo: capsules
292151|NCT01265524|B1|Baseline|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
292152|NCT01265524|P2|Participant Flow|Placebo|Placebo: capsules
292153|NCT01265524|P1|Participant Flow|Investigational Drug: CLP|Investigational drug: 15 g CLP per day given as capsules
292154|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
292155|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
292156|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
292157|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
292158|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
292159|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
292160|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
292161|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
292162|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
292163|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
292164|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
292165|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
292166|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
292167|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
292168|NCT01265524|E2|Reported Event|Placebo|Placebo: capsules
292169|NCT01265524|E1|Reported Event|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
292170|NCT01265511|B3|Baseline|Total|Total of all reporting groups
292171|NCT01265511|B2|Baseline|SCY-635 600 mg|"SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks~SCY-635: SCY-635 tablets, 300 mg bid for 28 days~peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks~Ribavirin: tablets given bid for up to 48 weeks"
292172|NCT01265511|B1|Baseline|Placebo|"Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks~Placebo: Oral tablets given bid for 28 days~peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks~Ribavirin: tablets given bid for up to 48 weeks"
292173|NCT01265511|P2|Participant Flow|SCY-635 600 mg|"SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks~SCY-635: SCY-635 tablets, 300 mg bid for 28 days~peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks~Ribavirin: tablets given bid for up to 48 weeks"
292174|NCT01265511|P1|Participant Flow|Placebo|"Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks~Placebo: Oral tablets given bid for 28 days~peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks~Ribavirin: tablets given bid for up to 48 weeks"
292175|NCT01265511|O2|Outcome|SCY-635 600 mg|"SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks~SCY-635: SCY-635 tablets, 300 mg bid for 28 days~peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks~Ribavirin: tablets given bid for up to 48 weeks"
292176|NCT01265511|O1|Outcome|Placebo|"Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks~Placebo: Oral tablets given bid for 28 days~peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks~Ribavirin: tablets given bid for up to 48 weeks"
292177|NCT01265511|O2|Outcome|SCY-635 600 mg|"SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks~SCY-635: SCY-635 tablets, 300 mg bid for 28 days~peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks~Ribavirin: tablets given bid for up to 48 weeks"
292230|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292231|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292178|NCT01265511|O1|Outcome|Placebo|"Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks~Placebo: Oral tablets given bid for 28 days~peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks~Ribavirin: tablets given bid for up to 48 weeks"
292179|NCT01265511|O2|Outcome|SCY-635 600 mg|"SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks~SCY-635: SCY-635 tablets, 300 mg bid for 28 days~peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks~Ribavirin: tablets given bid for up to 48 weeks"
292180|NCT01265511|O1|Outcome|Placebo|"Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks~Placebo: Oral tablets given bid for 28 days~peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks~Ribavirin: tablets given bid for up to 48 weeks"
292181|NCT01265511|O2|Outcome|SCY-635 600 mg|"SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks~SCY-635: SCY-635 tablets, 300 mg bid for 28 days~peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks~Ribavirin: tablets given bid for up to 48 weeks"
292182|NCT01265511|O1|Outcome|Placebo|"Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks~Placebo: Oral tablets given bid for 28 days~peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks~Ribavirin: tablets given bid for up to 48 weeks"
292183|NCT01265511|E2|Reported Event|SCY-635 600 mg|"SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks~SCY-635: SCY-635 tablets, 300 mg bid for 28 days~peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks~Ribavirin: tablets given bid for up to 48 weeks"
292184|NCT01265511|E1|Reported Event|Placebo|"Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks~Placebo: Oral tablets given bid for 28 days~peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks~Ribavirin: tablets given bid for up to 48 weeks"
292185|NCT01265498|B3|Baseline|Total|Total of all reporting groups
292186|NCT01265498|B2|Baseline|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292187|NCT01265498|B1|Baseline|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292188|NCT01265498|P2|Participant Flow|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292189|NCT01265498|P1|Participant Flow|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292190|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292191|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292192|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292193|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292194|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292195|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292196|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292197|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292198|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292199|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292200|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292201|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292202|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292203|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292204|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292205|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292206|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292207|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292208|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292209|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292210|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292211|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292212|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292213|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292214|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292215|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292216|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292217|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292218|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292219|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292220|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292221|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292222|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292223|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292224|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292225|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292226|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292227|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292228|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292229|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292235|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292236|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292237|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292238|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292239|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292240|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292241|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292242|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292243|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292244|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292245|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292246|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292247|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292248|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292249|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292250|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292251|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292252|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292253|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292254|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292255|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292256|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292257|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292258|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292259|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292260|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292261|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292262|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292263|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292264|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292265|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292266|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292267|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292268|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292269|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292270|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292271|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292272|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292273|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292274|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292275|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292276|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292277|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292278|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292279|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292280|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292281|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292282|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292283|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292284|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292285|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292286|NCT01265498|E2|Reported Event|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
292287|NCT01265498|E1|Reported Event|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
292288|NCT01265459|B4|Baseline|Total|Total of all reporting groups
292289|NCT01265459|B3|Baseline|Durolane 6 mL|Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
292290|NCT01265459|B2|Baseline|Durolane 4.5 mL|Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
292291|NCT01265459|B1|Baseline|Durolane 3 mL|Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
292292|NCT01265459|P3|Participant Flow|Durolane 6 mL|Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
292293|NCT01265459|P2|Participant Flow|Durolane 4.5 mL|Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
292294|NCT01265459|P1|Participant Flow|Durolane 3 mL|Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
292295|NCT01265459|O3|Outcome|Durolane 6 mL|"Subject´s global assessment of the status of the study knee at 26 weeks (change from baseline).~Single injection of Durolane (20 mg/ml)."
292296|NCT01265459|O2|Outcome|Durolane 4.5 mL|"Subject´s global assessment of the status of the study knee at 26 weeks (change from baseline).~Single injection of Durolane (20 mg/ml)."
292297|NCT01265459|O1|Outcome|Durolane 3 mL|"Subject´s global assessment of the status of the study knee at 26 weeks (change from baseline).~Single injection of Durolane (20 mg/ml)."
292298|NCT01265459|O3|Outcome|Durolane 6 mL|WOMAC physical function score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
292299|NCT01265459|O2|Outcome|Durolane 4.5 mL|WOMAC physical function score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
292300|NCT01265459|O1|Outcome|Durolane 3 mL|WOMAC physical function score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
292301|NCT01265459|O3|Outcome|Durolane 6 mL|WOMAC stiffness score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
292302|NCT01265459|O2|Outcome|Durolane 4.5 mL|WOMAC stiffness score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
292303|NCT01265459|O1|Outcome|Durolane 3 mL|WOMAC stiffness score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
292304|NCT01265459|O3|Outcome|Durolane 6 mL|Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
292305|NCT01265459|O2|Outcome|Durolane 4.5 mL|Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
292306|NCT01265459|O1|Outcome|Durolane 3 mL|Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
292307|NCT01265459|O3|Outcome|Durolane 6 mL|WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).
292308|NCT01265459|O2|Outcome|Durolane 4.5 mL|WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).
292309|NCT01265459|O1|Outcome|Durolane 3 mL|WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).
292310|NCT01265459|E3|Reported Event|Durolane 6 mL|Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
292311|NCT01265459|E2|Reported Event|Durolane 4.5 mL|Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
292312|NCT01265459|E1|Reported Event|Durolane 3 mL|Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
292313|NCT01265446|B3|Baseline|Total|Total of all reporting groups
292314|NCT01265446|B2|Baseline|Lidocaine 1mg + CPC 2mg|one single dose
292315|NCT01265446|B1|Baseline|Lidocaine 8mg +CPC 2mg|one single dose
292316|NCT01265446|P2|Participant Flow|Lidocaine 1mg + CPC 2mg|one single dose
292317|NCT01265446|P1|Participant Flow|Lidocaine 8mg +CPC 2mg|one single dose
292318|NCT01265446|O2|Outcome|Lidocaine 1mg + CPC 2mg|one single dose
292319|NCT01265446|O1|Outcome|Lidocaine 8mg +CPC 2mg|one single dose
292320|NCT01265446|O2|Outcome|Lidocaine 1mg + CPC 2mg|one single dose
292321|NCT01265446|O1|Outcome|Lidocaine 8mg +CPC 2mg|one single dose
292322|NCT01265446|E2|Reported Event|Lidocaine 1mg + CPC 2mg|one single dose
292323|NCT01265446|E1|Reported Event|Lidocaine 8mg +CPC 2mg|one single dose
292324|NCT01265420|B1|Baseline|Injectable Clostridial Collagenase|Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
292325|NCT01265420|P1|Participant Flow|Injectable Clostridial Collagenase|Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
292326|NCT01265420|O1|Outcome|Injectable Clostridial Collagenase|Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
292327|NCT01265420|E1|Reported Event|Injectable Clostridial Collagenase|Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
292328|NCT01265394|B1|Baseline|(18F) Flutemetamol|[18F] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
292329|NCT01265394|P1|Participant Flow|(18F) Flutemetamol|[18F] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
292330|NCT01265394|O1|Outcome|(18F) Flutemetamol Injection|Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
292331|NCT01265394|O1|Outcome|Normal and Abnormal Reads With or Without Amyloid|Each Subject received a dose of [18F] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
292332|NCT01265394|E1|Reported Event|(18F) Flutemetamol|[18F] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
292333|NCT01265056|B3|Baseline|Total|Total of all reporting groups
292334|NCT01265056|B2|Baseline|Gabapentin|Patients in this group received gabapentin which looked just like the sugar pill.
292335|NCT01265056|B1|Baseline|Sugar Pill|Patients in this group received a sugar pill which looked identical to gabapentin.
292336|NCT01265056|P2|Participant Flow|Gabapentin|Patients in this group received gabapentin which looked just like the sugar pill.
292337|NCT01265056|P1|Participant Flow|Sugar Pill|Patients in this group received a sugar pill which looked identical to gabapentin.
292338|NCT01265056|O2|Outcome|Gabapentin|Patients received gabapentin.
292339|NCT01265056|O1|Outcome|Placebo|Patients received a sugar pill similar to gabapentin.
292340|NCT01265056|O2|Outcome|Gabapentin|Patients received gabapentin.
292341|NCT01265056|O1|Outcome|Placebo|Patients received a sugar pill similar to gabapentin.
292342|NCT01265056|O2|Outcome|Gabapentin|Patients received gabapentin.
292343|NCT01265056|O1|Outcome|Placebo|Patients received a sugar pill similar to gabapentin.
292344|NCT01265056|E2|Reported Event|Gabapentin|Patients in this group received gabapentin which looked just like the sugar pill.
292345|NCT01265056|E1|Reported Event|Sugar Pill|Patients in this group received a sugar pill which looked identical to gabapentin.
292346|NCT01264952|B4|Baseline|Total|Total of all reporting groups
292347|NCT01264952|B3|Baseline|Group III|Patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
292449|NCT01264770|O5|Outcome|Dosing Group E|PLACEBO (COMBINED)
292348|NCT01264952|B2|Baseline|Group II|Patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non‐treated metastases were removed with liver resection.
292349|NCT01264952|B1|Baseline|Group I|Patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non‐treated metastases on the right side were removed with right hemihepatectomy.
292350|NCT01264952|P3|Participant Flow|Group III|The third group included patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
292351|NCT01264952|P2|Participant Flow|Group II|The second group (group II) included patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non‐treated metastases were removed with liver resection.
292352|NCT01264952|P1|Participant Flow|Group I|The first group included patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non‐treated metastases on the right side were removed with right hemihepatectomy.
292353|NCT01264952|O3|Outcome|Group III|Patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
292354|NCT01264952|O2|Outcome|Group II|Patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non‐treated metastases were removed with liver resection.
292355|NCT01264952|O1|Outcome|Group I|Patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non‐treated metastases on the right side were removed with right hemihepatectomy.
292356|NCT01264952|O3|Outcome|Group III|Patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
292357|NCT01264952|O2|Outcome|Group II|Patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non‐treated metastases were removed with liver resection.
292358|NCT01264952|O1|Outcome|Group I|Patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non‐treated metastases on the right side were removed with right hemihepatectomy.
292359|NCT01264952|O3|Outcome|Group III|Patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
292360|NCT01264952|O2|Outcome|Group II|Patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non‐treated metastases were removed with liver resection.
292361|NCT01264952|O1|Outcome|Group I|Patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non‐treated metastases on the right side were removed with right hemihepatectomy.
292362|NCT01264952|E3|Reported Event|Group III|Patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
292450|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
292451|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
292452|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
292453|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
292363|NCT01264952|E2|Reported Event|Group II|Patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non‐treated metastases were removed with liver resection.
292364|NCT01264952|E1|Reported Event|Group I|Patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non‐treated metastases on the right side were removed with right hemihepatectomy.
292365|NCT01264939|B3|Baseline|Total|Total of all reporting groups
292366|NCT01264939|B2|Baseline|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
292367|NCT01264939|B1|Baseline|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
292368|NCT01264939|P2|Participant Flow|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
292369|NCT01264939|P1|Participant Flow|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
292370|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
292371|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
292372|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
292373|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
292374|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
292375|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
292376|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
292377|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
292378|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
292379|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
292380|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
292381|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
292382|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
292383|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
292384|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
292385|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
292386|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
292387|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
292388|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
292389|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
292390|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
292391|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
292392|NCT01264939|E2|Reported Event|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
292393|NCT01264939|E1|Reported Event|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
292394|NCT01264887|B1|Baseline|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
292395|NCT01264887|P1|Participant Flow|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
292396|NCT01264887|O1|Outcome|Frequency of Treatment Emergent Adverse Events|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
292397|NCT01264887|O1|Outcome|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
292454|NCT01264770|O7|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
292455|NCT01264770|O6|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
292398|NCT01264887|O1|Outcome|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
292399|NCT01264887|O1|Outcome|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
292400|NCT01264887|O1|Outcome|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
292401|NCT01264887|O1|Outcome|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
292402|NCT01264887|O1|Outcome|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
292403|NCT01264887|O1|Outcome|Number of Treatment Emergent Adverse Events|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
292404|NCT01264887|E1|Reported Event|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
292405|NCT01264835|B1|Baseline|Slotted Anoscope|Subjects consenting to have hemorrhoidectomy with the slotted anoscope
292406|NCT01264835|P1|Participant Flow|Slotted Anoscope|Subjects consenting to have hemorrhoidectomy with the slotted anoscope
292407|NCT01264835|O1|Outcome|Slotted Anoscope|Subjects consenting to have hemorrhoidectomy with the slotted anoscope
292408|NCT01264835|E1|Reported Event|Slotted Anoscope|Subjects consenting to have hemorrhoidectomy with the slotted anoscope
292409|NCT01264770|B7|Baseline|Total|Total of all reporting groups
292410|NCT01264770|B6|Baseline|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO|Dosing Group G
292411|NCT01264770|B5|Baseline|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO|Dosing Group F
292412|NCT01264770|B4|Baseline|ADALIMUMAB 40 MG SC|Dosing Group D
292413|NCT01264770|B3|Baseline|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO|Dosing Group C
292414|NCT01264770|B2|Baseline|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
292415|NCT01264770|B1|Baseline|FOSTA 100 MG BID PO|Dosing Group A
292416|NCT01264770|P6|Participant Flow|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO|Dosing Group G
292417|NCT01264770|P5|Participant Flow|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO|Dosing Group F
292418|NCT01264770|P4|Participant Flow|ADALIMUMAB 40 MG SC|Dosing Group D
292419|NCT01264770|P3|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO|Dosing Group C
292420|NCT01264770|P2|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
292421|NCT01264770|P1|Participant Flow|FOSTA 100 MG BID PO|Dosing Group A
292422|NCT01264770|O6|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
292423|NCT01264770|O5|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
292424|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
292425|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
292426|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
292427|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
292428|NCT01264770|O6|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
292429|NCT01264770|O5|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
292430|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
292431|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
292432|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
292433|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
292434|NCT01264770|O6|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
292435|NCT01264770|O5|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
292436|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
292437|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
292438|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
292439|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
292440|NCT01264770|O5|Outcome|Dosing Group E|PLACEBO (COMBINED)
292441|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
292442|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
292443|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
292444|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
292445|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
292446|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
292447|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
292448|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
292458|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
292459|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
292460|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
292461|NCT01264770|O7|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
292462|NCT01264770|O6|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
292463|NCT01264770|O5|Outcome|Dosing Group E|PLACEBO (COMBINED)
292464|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
292465|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
292466|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
292467|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
292468|NCT01264770|O7|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
292469|NCT01264770|O6|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
292470|NCT01264770|O5|Outcome|Dosing Group E|PLACEBO (COMBINED)
292471|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
292472|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
292473|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
292474|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
292475|NCT01264770|O6|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
292476|NCT01264770|O5|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
292477|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
292478|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
292479|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
292480|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
292481|NCT01264770|O5|Outcome|Dosing Group E|PLACEBO (COMBINED)
292482|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
292483|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
292484|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
292485|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
292486|NCT01264770|O6|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
292487|NCT01264770|O5|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
292488|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
292489|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
292490|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
292491|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
292492|NCT01264770|O4|Outcome|Dosing Group E|PLACEBO (COMBINED)
292493|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
292494|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
292495|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
292496|NCT01264770|E8|Reported Event|PLACEBO (6 WKS) THEN FOSTA 100 MG BID - Placebo Period|
292497|NCT01264770|E7|Reported Event|PLACEBO (6 WKS) THEN FOSTA 100 MG BID - FOSTA Period|
292498|NCT01264770|E6|Reported Event|PLACEBO (6 WKS) FOSTA 100 MG BID (4 WKS) 150 MG QD-PBO Period|
292499|NCT01264770|E5|Reported Event|PLACEBO (6 WKS) FOSTA 100 MG BID (4 WKS) 150 MG QD-FOSTAperiod|
292500|NCT01264770|E4|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD|
292501|NCT01264770|E3|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD|Dosing Group C
292502|NCT01264770|E2|Reported Event|FOSTA 100 MG BID|Dosing Group A
292503|NCT01264770|E1|Reported Event|ADALIMUMAB 40 MG|Dosing Group D
292504|NCT01264679|B1|Baseline|Ferumoxytol|When a participant had persistent or recurrent IDA (defined as hemoglobin <12.0 g/dL and with either TSAT ≤40% or ferritin <100 ng/mL), the participant began a 7-week treatment period. Participants received 2 IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first dose administered on Day 1 and the second on Days 3 through 9 of the Treatment Period.
292505|NCT01264679|P1|Participant Flow|Ferumoxytol|When a participant had persistent or recurrent iron deficiency anemia (IDA) (defined as hemoglobin <12.0 grams [g]/deciliter [dL] and with either transferrin saturation [TSAT] <40% or ferritin <100 nanograms [ng]/milliliter [mL]), the participant began a 7-week treatment period. Participants received 2 intravenous (IV) injections of ferumoxytol 7.0 milligrams [mg] iron (Fe)/kilogram (kg) (maximum of 510 mg/dose), the first dose administered on Day 1 and the second on Days 3 through 9 of the Treatment Period.
292506|NCT01264679|O1|Outcome|Ferumoxytol|When a participant had persistent or recurrent IDA (defined as hemoglobin <12.0 g/dL and with either TSAT ≤40% or ferritin <100 ng/mL), the participant began a 7-week treatment period. Participants received 2 IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first dose administered on Day 1 and the second on Days 3 through 9 of the Treatment Period.
292507|NCT01264679|O1|Outcome|Ferumoxytol|When a participant had persistent or recurrent IDA (defined as hemoglobin <12.0 g/dL and with either TSAT ≤40% or ferritin <100 ng/mL), the participant began a 7-week treatment period. Participants received 2 IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose /dose), the first dose administered on Day 1 and the second on Days 3 through 9 of the Treatment Period.
292508|NCT01264679|O1|Outcome|Ferumoxytol|When a participant had persistent or recurrent IDA (defined as hemoglobin <12.0 g/dL and with either TSAT ≤40% or ferritin <100 ng/mL), the participant began a 7-week treatment period. Participants received 2 IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first dose administered on Day 1 and the second on Days 3 through 9 of the Treatment Period.
292509|NCT01264679|E1|Reported Event|Ferumoxytol|When a participant had persistent or recurrent IDA (defined as hemoglobin <12.0 g/dL and with either TSAT ≤40% or ferritin <100 ng/mL), the participant began a 7-week treatment period. Participants received 2 IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first dose administered on Day 1 and the second on Days 3 through 9 of the Treatment Period.
292510|NCT01264614|B3|Baseline|Total|Total of all reporting groups
292511|NCT01264614|B2|Baseline|Normative Older Adults|Normative older adults with no known history of neurological condition.
292512|NCT01264614|B1|Baseline|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
292513|NCT01264614|P2|Participant Flow|Normative Older Adults|Normative older adults with no known history of neurological condition.
292514|NCT01264614|P1|Participant Flow|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
292515|NCT01264614|O2|Outcome|Normative Older Adults|Normative older adults with no known history of neurological condition.
292516|NCT01264614|O1|Outcome|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
292517|NCT01264614|O2|Outcome|Normative Older Adults|Normative older adults with no known history of neurological condition.
292518|NCT01264614|O1|Outcome|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
292519|NCT01264614|O2|Outcome|Normative Older Adults|Normative older adults with no known history of neurological condition.
292520|NCT01264614|O1|Outcome|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
292521|NCT01264614|O2|Outcome|Normative Older Adults|Normative older adults with no known history of neurological condition.
292522|NCT01264614|O1|Outcome|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
292523|NCT01264614|O2|Outcome|Normative Older Adults|Normative older adults with no known history of neurological condition.
292524|NCT01264614|O1|Outcome|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
292525|NCT01264614|E2|Reported Event|Normative Older Adults|Normative older adults with no known history of neurological condition.
292526|NCT01264614|E1|Reported Event|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
292527|NCT01264601|B3|Baseline|Total|Total of all reporting groups
292528|NCT01264601|B2|Baseline|Graded Challenge|"Subjects in this arm will receive TIV by standard 10%/90% 2-step graded challenge split of the age appropriate dose, separated by 30 minutes. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose.~Trivalent Influenza Vaccine : Age appropriate dose of seasonal Trivalent Influenza Vaccine (TIV), either 0.25mL under age 3 or 0.5mL over the age of 3."
292529|NCT01264601|B1|Baseline|Single Dose|"This arm will receive TIV as 2 doses, the first of which will be normal saline administered at approximately 10% of the total age appropriate dose volume, followed 30 minutes later by the full age appropriate dose. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose.~Trivalent Influenza Vaccine : Age appropriate dose of seasonal Trivalent Influenza Vaccine (TIV), either 0.25mL under age 3 or 0.5mL over the age of 3."
292530|NCT01264601|P2|Participant Flow|Graded Challenge|"Subjects in this arm will receive TIV by standard 10%/90% 2-step graded challenge split of the age appropriate dose, separated by 30 minutes. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose.~Trivalent Influenza Vaccine : Age appropriate dose of seasonal Trivalent Influenza Vaccine (TIV), either 0.25mL under age 3 or 0.5mL over the age of 3."
292531|NCT01264601|P1|Participant Flow|Single Dose|"This arm will receive TIV as 2 doses, the first of which will be normal saline administered at approximately 10% of the total age appropriate dose volume, followed 30 minutes later by the full age appropriate dose. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose.~Trivalent Influenza Vaccine : Age appropriate dose of seasonal Trivalent Influenza Vaccine (TIV), either 0.25mL under age 3 or 0.5mL over the age of 3."
292532|NCT01264601|O2|Outcome|Graded Challenge|"Subjects in this arm will receive TIV by standard 10%/90% 2-step graded challenge split of the age appropriate dose, separated by 30 minutes. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose.~Trivalent Influenza Vaccine : Age appropriate dose of seasonal Trivalent Influenza Vaccine (TIV), either 0.25mL under age 3 or 0.5mL over the age of 3."
292533|NCT01264601|O1|Outcome|Single Dose|"This arm will receive TIV as 2 doses, the first of which will be normal saline administered at approximately 10% of the total age appropriate dose volume, followed 30 minutes later by the full age appropriate dose. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose.~Trivalent Influenza Vaccine : Age appropriate dose of seasonal Trivalent Influenza Vaccine (TIV), either 0.25mL under age 3 or 0.5mL over the age of 3."
292534|NCT01264601|O2|Outcome|Graded Challenge|"Subjects in this arm will receive TIV by standard 10%/90% 2-step graded challenge split of the age appropriate dose, separated by 30 minutes. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose.~Trivalent Influenza Vaccine : Age appropriate dose of seasonal Trivalent Influenza Vaccine (TIV), either 0.25mL under age 3 or 0.5mL over the age of 3."
292535|NCT01264601|O1|Outcome|Single Dose|"This arm will receive TIV as 2 doses, the first of which will be normal saline administered at approximately 10% of the total age appropriate dose volume, followed 30 minutes later by the full age appropriate dose. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose.~Trivalent Influenza Vaccine : Age appropriate dose of seasonal Trivalent Influenza Vaccine (TIV), either 0.25mL under age 3 or 0.5mL over the age of 3."
292536|NCT01264601|E2|Reported Event|Graded Challenge|"Subjects in this arm will receive TIV by standard 10%/90% 2-step graded challenge split of the age appropriate dose, separated by 30 minutes. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose.~Trivalent Influenza Vaccine : Age appropriate dose of seasonal Trivalent Influenza Vaccine (TIV), either 0.25mL under age 3 or 0.5mL over the age of 3."
292537|NCT01264601|E1|Reported Event|Single Dose|"This arm will receive TIV as 2 doses, the first of which will be normal saline administered at approximately 10% of the total age appropriate dose volume, followed 30 minutes later by the full age appropriate dose. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose.~Trivalent Influenza Vaccine : Age appropriate dose of seasonal Trivalent Influenza Vaccine (TIV), either 0.25mL under age 3 or 0.5mL over the age of 3."
292570|NCT01264016|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.
292538|NCT01264380|B1|Baseline|All Participants|Included all participants who received single oral dose of vemurafenib tablet at 960 mg in fasted condition first and fed condition first in Period A and Period B and twice daily dose of vemurafenib tablet at 960 mg in Period C.
292539|NCT01264380|P3|Participant Flow|Vemurafenib (RO5185426)|Participants received vemurafenib tablet at 960 mg orally twice daily in 21-day cycles starting from Day 21 until disease progression, unacceptable toxicity, or consent withdrawal (Period C).
292540|NCT01264380|P2|Participant Flow|Vemurafenib (RO5185426): Fed Then Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition (Period A [Day 1 to Day 10]) followed by single oral dose of vemurafenib tablet at 960 mg on Day 1 in fasted condition Period B [Day 11 to Day 20]). A washout period of 10 days was maintained between Period A and B.
292541|NCT01264380|P1|Participant Flow|Vemurafenib (RO5185426): Fasted Then Fed|Single oral dose of vemurafenib tablet at 960 milligrams (mg) on Day 1 was administered to participants in fasted condition (Period A [Day 1 to Day 10]) followed by single oral dose of vemurafenib tablet at 960 mg on Day 1 in fed condition (Period B [Day 11 to Day 20]). A washout period of 10 days was maintained between Period A and B.
292542|NCT01264380|O1|Outcome|Vemurafenib (RO5185426)|Participants received vemurafenib tablet at 960 mg orally twice daily in 21-day cycles starting from Day 21 until disease progression, unacceptable toxicity, or consent withdrawal (Period C).
292543|NCT01264380|O1|Outcome|Vemurafenib (RO5185426)|Participants received vemurafenib tablet at 960 mg orally twice daily in 21-day cycles starting from Day 21 until disease progression, unacceptable toxicity, or consent withdrawal (Period C).
292544|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
292545|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
292546|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
292547|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
292548|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
292549|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
292550|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
292551|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
292552|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
292553|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
292554|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
292555|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
292556|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
292557|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
292558|NCT01264380|E3|Reported Event|Vemurafenib (RO5185426)|Participants received vemurafenib tablet at 960 mg orally twice daily in 21-day cycles starting from Day 21 until disease progression, unacceptable toxicity, or consent withdrawal (Period C).
292559|NCT01264380|E2|Reported Event|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 milligram (mg) on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
292560|NCT01264380|E1|Reported Event|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 milligram (mg) on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
292561|NCT01264081|B1|Baseline|Lapatinib|Lapatinib: 500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.
292562|NCT01264081|P1|Participant Flow|Lapatinib|Lapatinib: 500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.
292563|NCT01264081|O1|Outcome|Lapatinib|Lapatinib: 500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.
292564|NCT01264081|O1|Outcome|Lapatinib|Lapatinib: 500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.
292565|NCT01264081|E1|Reported Event|Lapatinib|Lapatinib: 500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.
292566|NCT01264016|B1|Baseline|Intended Users of the Monitoring System|Untrained subjects with diabetes use an investigational blood glucose monitoring system. One subject withdrew voluntarily; one subject was withdrawn. One subject hematocrit measurement was missing so subject data was not evaluable.
292567|NCT01264016|P1|Participant Flow|Intended Users of the Monitoring System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.
292568|NCT01264016|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.
292569|NCT01264016|O1|Outcome|Study Staff Test Subject Venous Blood|Healthcare professionals (study staff) used an investigational blood glucose monitoring system (BGMS) with subject venous blood.
292571|NCT01264016|E1|Reported Event|Intended Users of the Monitoring System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.
292572|NCT01263925|B3|Baseline|Total|Total of all reporting groups
292573|NCT01263925|B2|Baseline|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
292574|NCT01263925|B1|Baseline|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
292575|NCT01263925|P2|Participant Flow|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
292576|NCT01263925|P1|Participant Flow|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
292577|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
292578|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
292579|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
292580|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
292581|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
292582|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
292583|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
292584|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
292585|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
292586|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
292587|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
292588|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
292589|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
292590|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
292591|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
292592|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
292593|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
292594|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
292595|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
292596|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
292597|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
292598|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
292599|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
292600|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
292627|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
329278|NCT01174446|O2|Outcome|On-Demand|Study Part 2 Only
292601|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
292602|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
292603|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
292604|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
292605|NCT01263925|E2|Reported Event|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
292606|NCT01263925|E1|Reported Event|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
292607|NCT01263873|B3|Baseline|Total|Total of all reporting groups
292608|NCT01263873|B2|Baseline|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
292609|NCT01263873|B1|Baseline|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
292610|NCT01263873|P2|Participant Flow|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
292611|NCT01263873|P1|Participant Flow|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
292612|NCT01263873|O2|Outcome|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
292613|NCT01263873|O1|Outcome|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
292614|NCT01263873|O2|Outcome|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
292615|NCT01263873|O1|Outcome|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
292616|NCT01263873|O2|Outcome|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
292617|NCT01263873|O1|Outcome|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
292618|NCT01263873|E2|Reported Event|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
292619|NCT01263873|E1|Reported Event|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
292620|NCT01263717|B3|Baseline|Total|Total of all reporting groups
292621|NCT01263717|B2|Baseline|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
292622|NCT01263717|B1|Baseline|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
292623|NCT01263717|P2|Participant Flow|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
292624|NCT01263717|P1|Participant Flow|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
292625|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
292626|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
292961|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
292628|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
292629|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
292630|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
292631|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
292632|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
292633|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
292634|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
292635|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
292636|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
292637|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
292638|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
292639|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
292640|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
292641|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
292642|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
292643|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
292644|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
292645|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
292646|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
292647|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
292648|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
292649|NCT01263717|E2|Reported Event|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
292650|NCT01263717|E1|Reported Event|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
292651|NCT01263704|B1|Baseline|Rituximab Plus Fludarabine and Cyclophosphamide|Elderly participants with chronic lymphocytic leukemia (CLL) received combination treatment with low-dose fludarabine and cyclophosphamide combined with standard-dose of rituximab for 6 months. Treatment was followed by a follow up period of 36 months.
292652|NCT01263704|P1|Participant Flow|Rituximab Plus Fludarabine and Cyclophosphamide|Elderly participants with chronic lymphocytic leukemia (CLL) received combination treatment with low-dose fludarabine and cyclophosphamide combined with standard-dose of rituximab for 6 months. Treatment was followed by a follow up period of 36 months.
292653|NCT01263704|O1|Outcome|Rituximab Plus Fludarabine and Cyclophosphamide|Elderly participants with chronic lymphocytic leukemia (CLL) received combination treatment with low-dose fludarabine and cyclophosphamide combined with standard-dose of rituximab for 6 months. Treatment was followed by a follow up period of 36 months.
292654|NCT01263704|O1|Outcome|Rituximab Plus Fludarabine and Cyclophosphamide|Elderly participants with chronic lymphocytic leukemia (CLL) received combination treatment with low-dose fludarabine and cyclophosphamide combined with standard-dose of rituximab for 6 months. Treatment was followed by a follow up period of 36 months.
292655|NCT01263704|O1|Outcome|Rituximab Plus Fludarabine and Cyclophosphamide|Elderly participants with chronic lymphocytic leukemia (CLL) received combination treatment with low-dose fludarabine and cyclophosphamide combined with standard-dose of rituximab for 6 months. Treatment was followed by a follow up period of 36 months.
292731|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292656|NCT01263704|O1|Outcome|Rituximab Plus Fludarabine and Cyclophosphamide|Elderly participants with chronic lymphocytic leukemia (CLL) received combination treatment with low-dose fludarabine and cyclophosphamide combined with standard-dose of rituximab for 6 months. Treatment was followed by a follow up period of 36 months.
292657|NCT01263704|O1|Outcome|Rituximab Plus Fludarabine and Cyclophosphamide|Elderly participants with chronic lymphocytic leukemia (CLL) received combination treatment with low-dose fludarabine and cyclophosphamide combined with standard-dose of rituximab for 6 months. Treatment was followed by a follow up period of 36 months.
292658|NCT01263704|O1|Outcome|Rituximab Plus Fludarabine and Cyclophosphamide|Elderly participants with chronic lymphocytic leukemia (CLL) received combination treatment with low-dose fludarabine and cyclophosphamide combined with standard-dose of rituximab for 6 months. Treatment was followed by a follow up period of 36 months.
292659|NCT01263704|E1|Reported Event|Rituximab Plus Fludarabine and Cyclophosphamide|Elderly participants with chronic lymphocytic leukemia (CLL) received combination treatment with low-dose fludarabine and cyclophosphamide combined with standard-dose of rituximab for 6 months. Treatment was followed by a follow up period of 36 months.
292660|NCT01263691|B7|Baseline|Total|Total of all reporting groups
292661|NCT01263691|B6|Baseline|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
292662|NCT01263691|B5|Baseline|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292663|NCT01263691|B4|Baseline|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292664|NCT01263691|B3|Baseline|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292665|NCT01263691|B2|Baseline|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292666|NCT01263691|B1|Baseline|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
292667|NCT01263691|P6|Participant Flow|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
292668|NCT01263691|P5|Participant Flow|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL anthrax vaccine adsorbed [AVA] + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292669|NCT01263691|P4|Participant Flow|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL anthrax vaccine adsorbed [AVA] + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292670|NCT01263691|P3|Participant Flow|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL anthrax vaccine adsorbed [AVA] + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292671|NCT01263691|P2|Participant Flow|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL anthrax vaccine adsorbed [AVA] + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292672|NCT01263691|P1|Participant Flow|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
292673|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292674|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292675|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292676|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292677|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292678|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292679|NCT01263691|O18|Outcome|Female Saline|Female participants between 18 and 50 years of age who received two doses of saline; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292732|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
292733|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
292680|NCT01263691|O17|Outcome|Female AV7909 Formulation 4|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292681|NCT01263691|O16|Outcome|Female AV7909 Formulation 3|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292682|NCT01263691|O15|Outcome|Female AV7909 Formulation 2|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292683|NCT01263691|O14|Outcome|Female AV7909 Formulation 1|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292684|NCT01263691|O13|Outcome|Female BioThrax|Female Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292685|NCT01263691|O12|Outcome|Male Saline|Male participants between 18 and 50 years of age who received two doses of saline; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292686|NCT01263691|O11|Outcome|Male AV7909 Formulation 4|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292687|NCT01263691|O10|Outcome|Male AV7909 Formulation 3|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292688|NCT01263691|O9|Outcome|Male AV7909 Formulation 2|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292689|NCT01263691|O8|Outcome|Male AV7909 Formulation 1|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292690|NCT01263691|O7|Outcome|Male BioThrax|Male Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292691|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292692|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292693|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292694|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292695|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292734|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292962|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292696|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292697|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
292698|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292699|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292700|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292701|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292702|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
292703|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
292704|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292705|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292706|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292707|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292708|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
292709|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
292710|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292711|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292712|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292713|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292714|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
292715|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
292716|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292717|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292718|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292719|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292720|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
292721|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
292722|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292723|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292724|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292725|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292726|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
292727|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
292728|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292729|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292730|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292735|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292736|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292737|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292738|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
292739|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
292740|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292741|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292742|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292743|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292744|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
292745|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
292746|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292747|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292748|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292749|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292750|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
292751|NCT01263691|O18|Outcome|Female Saline|Female Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292752|NCT01263691|O17|Outcome|Female AV7909 Formulation 4|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292753|NCT01263691|O16|Outcome|Female AV7909 Formulation 3|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292754|NCT01263691|O15|Outcome|Female AV7909 Formulation 2|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292755|NCT01263691|O14|Outcome|Female AV7909 Formulation 1|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292756|NCT01263691|O13|Outcome|Female BioThrax|Female Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292757|NCT01263691|O12|Outcome|Male Saline|Male Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292758|NCT01263691|O11|Outcome|Male AV7909 Formulation 4|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292759|NCT01263691|O10|Outcome|Male AV7909 Formulation 3|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292956|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
292760|NCT01263691|O9|Outcome|Male AV7909 Formulation 2|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292761|NCT01263691|O8|Outcome|Male AV7909 Formulation 1|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292762|NCT01263691|O7|Outcome|Male BioThrax|Male Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292763|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292764|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292765|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292766|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292767|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292768|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
292769|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
292770|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292771|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292772|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292773|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292774|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
292775|NCT01263691|E6|Reported Event|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
292776|NCT01263691|E5|Reported Event|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292777|NCT01263691|E4|Reported Event|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292778|NCT01263691|E3|Reported Event|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292779|NCT01263691|E2|Reported Event|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
292780|NCT01263691|E1|Reported Event|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
292781|NCT01263665|B1|Baseline|Investigational Arm|25 cm length GORE® VIABAHN® Endoprosthesis with > PROPATEN Bioactive Surface Subjects
292782|NCT01263665|P1|Participant Flow|25 cm Length GORE® VIABAHN® Endoprosthesis With PROPATEN Bioac|"25 cm length GORE® VIABAHN® Endoprosthesis with~> PROPATEN Bioactive Surface Subjects"
292783|NCT01263665|O1|Outcome|25 cm Length GORE® VIABAHN® Endoprosthesis With PROPATEN Bioac|25 cm length GORE® VIABAHN® Endoprosthesis with > PROPATEN Bioactive Surface Subjects
292784|NCT01263665|O1|Outcome|25 cm Length GORE® VIABAHN® Endoprosthesis With PROPATEN Bioac|25 cm length GORE® VIABAHN® Endoprosthesis with > PROPATEN Bioactive Surface Subjects
292785|NCT01263665|E1|Reported Event|25 cm GORE VIABAHN|25 cm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface
292786|NCT01263639|B3|Baseline|Total|Total of all reporting groups
292787|NCT01263639|B2|Baseline|Control Group, Standard Care|"The intervention group will receive an attending photo/biosketch card within 24 hours of admission while the control group will not. The control group will receive the usual/standard care as provided to all orthopaedic trauma admission patients without receiving a biosketch card."
292788|NCT01263639|B1|Baseline|Intervention Group, Biosketch Card|The investigators aim to improve the patient-physician relationship and improve patient satisfaction by providing a biosketch card of the attending orthopaedic trauma surgeon to the patient. The biosketch card will include a picture of the attending orthopaedic surgeon with a brief synopsis of his or her: education background, specialty, surgical interests, research interests, and other interests including hobbies.
292789|NCT01263639|P2|Participant Flow|Control Group, Standard Care|"The intervention group will receive an attending photo/biosketch card within 24 hours of admission while the control group will not. The control group will receive the usual/standard care as provided to all orthopaedic trauma admission patients without receiving a biosketch card."
292790|NCT01263639|P1|Participant Flow|Intervention Group, Biosketch Card|The investigators aim to improve the patient-physician relationship and improve patient satisfaction by providing a biosketch card of the attending orthopaedic trauma surgeon to the patient. The biosketch card will include a picture of the attending orthopaedic surgeon with a brief synopsis of his or her: education background, specialty, surgical interests, research interests, and other interests including hobbies.
292791|NCT01263639|O2|Outcome|Control Group, Standard Care|"The intervention group will receive an attending photo/biosketch card within 24 hours of admission while the control group will not. The control group will receive the usual/standard care as provided to all orthopaedic trauma admission patients without receiving a biosketch card."
292792|NCT01263639|O1|Outcome|Intervention Group, Biosketch Card|The investigators aim to improve the patient-physician relationship and improve patient satisfaction by providing a biosketch card of the attending orthopaedic trauma surgeon to the patient. The biosketch card will include a picture of the attending orthopaedic surgeon with a brief synopsis of his or her: education background, specialty, surgical interests, research interests, and other interests including hobbies.
292793|NCT01263639|E2|Reported Event|Control Group, Standard Care|"The intervention group will receive an attending photo/biosketch card within 24 hours of admission while the control group will not. The control group will receive the usual/standard care as provided to all orthopaedic trauma admission patients without receiving a biosketch card."
292794|NCT01263639|E1|Reported Event|Intervention Group, Biosketch Card|The investigators aim to improve the patient-physician relationship and improve patient satisfaction by providing a biosketch card of the attending orthopaedic trauma surgeon to the patient. The biosketch card will include a picture of the attending orthopaedic surgeon with a brief synopsis of his or her: education background, specialty, surgical interests, research interests, and other interests including hobbies.
292795|NCT01263561|B3|Baseline|Total|Total of all reporting groups
292796|NCT01263561|B2|Baseline|ExPRESS|"ExPRESS miniature glaucoma drainage device~ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
292797|NCT01263561|B1|Baseline|Trabeculectomy|"trabeculectomy filtering surgery~trabeculectomy: trabeculectomy filtering surgery"
292798|NCT01263561|P2|Participant Flow|ExPRESS|"ExPRESS miniature glaucoma drainage device~ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
292799|NCT01263561|P1|Participant Flow|Trabeculectomy|"trabeculectomy filtering surgery~trabeculectomy: trabeculectomy filtering surgery"
292800|NCT01263561|O2|Outcome|ExPRESS|"ExPRESS miniature glaucoma drainage device~ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
292801|NCT01263561|O1|Outcome|Trabeculectomy|"trabeculectomy filtering surgery~trabeculectomy: trabeculectomy filtering surgery"
292802|NCT01263561|O2|Outcome|ExPRESS|"ExPRESS miniature glaucoma drainage device~ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
292803|NCT01263561|O1|Outcome|Trabeculectomy|"trabeculectomy filtering surgery~trabeculectomy: trabeculectomy filtering surgery"
292804|NCT01263561|O2|Outcome|ExPRESS|"ExPRESS miniature glaucoma drainage device~ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
292805|NCT01263561|O1|Outcome|Trabeculectomy|"trabeculectomy filtering surgery~trabeculectomy: trabeculectomy filtering surgery"
292806|NCT01263561|E2|Reported Event|ExPRESS|"ExPRESS miniature glaucoma drainage device~ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
292807|NCT01263561|E1|Reported Event|Trabeculectomy|"trabeculectomy filtering surgery~trabeculectomy: trabeculectomy filtering surgery"
292808|NCT01263509|B3|Baseline|Total|Total of all reporting groups
292809|NCT01263509|B2|Baseline|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292810|NCT01263509|B1|Baseline|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292811|NCT01263509|P4|Participant Flow|α-glucosidase Monotherapy Group*→ 25 mg Combination Group|"Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the α-glucosidase inhibitor monotherapy dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study."
292812|NCT01263509|P3|Participant Flow|α-glucosidase Monotherapy Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the α-glucosidase inhibitor monotherapy dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study."
292813|NCT01263509|P2|Participant Flow|25 mg Combination Dose Group* → 25 mg Combination Dose Group|"Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the for 25 mg combination dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study."
292814|NCT01263509|P1|Participant Flow|12.5 mg Combination Dose Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study."
292815|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292957|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292816|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292817|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292818|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292819|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292820|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292821|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292822|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292823|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292824|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292825|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292826|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292827|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292828|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292829|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292830|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292831|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292832|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292833|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292834|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292835|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292836|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292837|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292838|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292839|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292840|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292841|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292842|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292843|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292844|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292845|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292846|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292847|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292848|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292849|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292850|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292958|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
292851|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292852|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292853|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292854|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292855|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292856|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292857|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292858|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292859|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292860|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292861|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292862|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292863|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292864|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292865|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292866|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292867|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292868|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292869|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292870|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292871|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292872|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292873|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292874|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292875|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292876|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292877|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292878|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292879|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292880|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292881|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292882|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292883|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292884|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292885|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292959|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
292886|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292887|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292888|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292889|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292890|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292891|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292892|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292893|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292894|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292895|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292896|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292897|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292898|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292899|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292900|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292901|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292902|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292903|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292904|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292905|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292906|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292907|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292908|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292909|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292910|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292911|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292912|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292913|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292914|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292915|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292916|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292917|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292918|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292919|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292920|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292960|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
292921|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292922|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292923|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292924|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292925|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292926|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292927|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292928|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292929|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292930|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292931|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292932|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292933|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292934|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292935|NCT01263509|E2|Reported Event|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292936|NCT01263509|E1|Reported Event|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292937|NCT01263496|B6|Baseline|Total|Total of all reporting groups
292938|NCT01263496|B5|Baseline|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292939|NCT01263496|B4|Baseline|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
292940|NCT01263496|B3|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
292941|NCT01263496|B2|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
292942|NCT01263496|B1|Baseline|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
292943|NCT01263496|P9|Participant Flow|Placebo Dose Group* → Alogliptin 50 mg Dose Group|"Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.~*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
292944|NCT01263496|P8|Participant Flow|Placebo Dose Group* → Alogliptin 25 mg Dose Group|"Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.~*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
292945|NCT01263496|P7|Participant Flow|Placebo Dose Group* → Alogliptin 12.5 mg Dose Group|"Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.~*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
292946|NCT01263496|P6|Participant Flow|Placebo Dose Group* → Alogliptin 6.25 mg Dose Group|"Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.~*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
292947|NCT01263496|P5|Participant Flow|Voglibose 0.2 mg Dose Group* → Voglibose 0.2 mg Dose Group|"Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the voglibose 0.2 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
292948|NCT01263496|P4|Participant Flow|Alogliptin 50 mg Dose Group* → Alogliptin 50 mg Dose Group|"Alogliptin 50 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the 50 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
292949|NCT01263496|P3|Participant Flow|Alogliptin 25 mg Dose Group* → Alogliptin 25 mg Dose Group|"Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the 25 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
292950|NCT01263496|P2|Participant Flow|Alogliptin 12.5 mg Dose Group* → Alogliptin 12.5 mg Dose Group|"Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the 12.5 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
292951|NCT01263496|P1|Participant Flow|Alogliptin 6.25 mg Dose Group* → Alogliptin 6.25 mg Dose Group|"Alogliptin 6.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the 6.5 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
292952|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292953|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
292954|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
292955|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
292963|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
292964|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
292965|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
292966|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
292967|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292968|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
292969|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
292970|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
292971|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
292972|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292973|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
292974|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
292975|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
292976|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
292977|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292978|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
292979|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
292980|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
292981|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
292982|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292983|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
292984|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
292985|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
292986|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
292987|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292988|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
292989|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
292990|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
292991|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
292992|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292993|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
292994|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
292995|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
292996|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
292997|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
292998|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
292999|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293000|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293001|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293002|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293003|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293004|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293005|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293006|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293007|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293008|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293009|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293010|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293011|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293012|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293013|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293014|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293015|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293016|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293017|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293018|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293019|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293020|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293021|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293022|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293023|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293024|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293025|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293026|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293027|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293028|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293029|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293030|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293031|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293032|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293033|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293034|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293035|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293036|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293037|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293038|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293039|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293040|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293041|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293042|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293043|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293044|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293045|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293046|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293047|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293048|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293049|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293050|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293051|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293052|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293053|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293054|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293055|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293056|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293057|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293058|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293059|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293060|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293061|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293062|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293063|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293064|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293065|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293066|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293067|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293068|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293069|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293070|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293071|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293072|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293073|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293074|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293075|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293076|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293077|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293078|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293079|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293080|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293081|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293082|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293083|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293084|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293085|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293086|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293087|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293088|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293089|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293090|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293091|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293092|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293093|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293094|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293095|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293096|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293097|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293098|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293099|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293100|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293101|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293102|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293103|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293104|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293105|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293106|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293107|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293108|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293109|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293110|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293111|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293112|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293113|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293114|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293115|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293116|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293117|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293118|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293119|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293120|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293121|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293122|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293123|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293124|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293125|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293126|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293127|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293128|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293129|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293130|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293131|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293132|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293133|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293134|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293135|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293136|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293137|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293138|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293139|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293140|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293141|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293142|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293143|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293144|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293145|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293146|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293147|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293148|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293149|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293150|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293151|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293152|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293153|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293154|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293155|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293156|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293157|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293158|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293159|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293160|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293161|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293162|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293163|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293164|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293165|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293166|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293167|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293168|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293169|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293170|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293171|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293172|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293173|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293174|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293175|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293176|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293177|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293178|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293179|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293180|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293181|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293182|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293183|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293184|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293185|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293186|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293187|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293188|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293189|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293190|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293191|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293192|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293193|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293194|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293195|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293196|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293197|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293198|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293199|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293200|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293201|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293202|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293203|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293204|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293205|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293206|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293207|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293208|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293209|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293210|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293211|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293212|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293213|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293214|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293215|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293216|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293217|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293218|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293219|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293220|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293221|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293222|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293223|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293224|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293225|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293226|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293227|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293228|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293229|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293230|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293231|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293232|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293233|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293234|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293235|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293236|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293237|NCT01263496|E5|Reported Event|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
293238|NCT01263496|E4|Reported Event|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
293239|NCT01263496|E3|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
293240|NCT01263496|E2|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
293241|NCT01263496|E1|Reported Event|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
293242|NCT01263483|B4|Baseline|Total|Total of all reporting groups
293243|NCT01263483|B3|Baseline|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293244|NCT01263483|B2|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
293245|NCT01263483|B1|Baseline|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293246|NCT01263483|P3|Participant Flow|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293247|NCT01263483|P2|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
293248|NCT01263483|P1|Participant Flow|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293249|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293250|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
293251|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293252|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293253|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
293254|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293255|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293256|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
293257|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293258|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293259|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
293260|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293261|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293262|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
293263|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293264|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293265|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
293266|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293267|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293268|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
293269|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293270|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293271|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
293272|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293273|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293274|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
293275|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293276|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293277|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
329279|NCT01174446|O1|Outcome|Prophylaxis|Study Part 2 Only
293278|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293279|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293280|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
293281|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293282|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293283|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
293284|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293285|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293286|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
293287|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293288|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293289|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
293290|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293291|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293292|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
293293|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293294|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293295|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
293296|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293297|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293298|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
293299|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293300|NCT01263483|E3|Reported Event|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293301|NCT01263483|E2|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
293302|NCT01263483|E1|Reported Event|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293303|NCT01263470|B7|Baseline|Total|Total of all reporting groups
293304|NCT01263470|B6|Baseline|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293305|NCT01263470|B5|Baseline|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
293306|NCT01263470|B4|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
293307|NCT01263470|B3|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
293308|NCT01263470|B2|Baseline|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
293309|NCT01263470|B1|Baseline|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
293310|NCT01263470|P6|Participant Flow|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293311|NCT01263470|P5|Participant Flow|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
293312|NCT01263470|P4|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
293313|NCT01263470|P3|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
293314|NCT01263470|P2|Participant Flow|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
293315|NCT01263470|P1|Participant Flow|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
293316|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293317|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
293318|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
293319|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
293320|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
293321|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
293322|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293323|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
293324|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
294454|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
293325|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
293326|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
293327|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
293328|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293329|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
293330|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
293331|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
293332|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
293333|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
293334|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293335|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
293336|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
293337|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
293338|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
293339|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
293340|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293341|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
293342|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
293343|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
293344|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
293345|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
293346|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293347|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
293348|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
293349|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
293350|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
293351|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
293352|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293353|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
293354|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
293355|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
293356|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
293357|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
293358|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293359|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
293360|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
293361|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
293362|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
293363|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
293364|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293365|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
293366|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
293367|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
293368|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
293369|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
293370|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293371|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
293372|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
293373|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
293374|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
293375|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
293376|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293377|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
293378|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
329280|NCT01174446|O2|Outcome|On-Demand|Study Part 2 Only
293379|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
293380|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
293381|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
293382|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293383|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
293384|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
293385|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
293386|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
293387|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
293388|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293389|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
293390|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
293391|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
293392|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
293393|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
293394|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293395|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
293396|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
293397|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
293398|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
293399|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
293400|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293401|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
293402|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
293403|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
293404|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
293405|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
293406|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293407|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
293408|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
293409|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
293410|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
293411|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
293412|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293413|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
293414|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
293415|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
293416|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
293417|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
293418|NCT01263470|E6|Reported Event|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
293419|NCT01263470|E5|Reported Event|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
293420|NCT01263470|E4|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
293421|NCT01263470|E3|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
293422|NCT01263470|E2|Reported Event|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
293423|NCT01263470|E1|Reported Event|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
293424|NCT01263444|B1|Baseline|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
293425|NCT01263444|P1|Participant Flow|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
293426|NCT01263444|O1|Outcome|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
293427|NCT01263444|O1|Outcome|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
293428|NCT01263444|O1|Outcome|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
293429|NCT01263444|O1|Outcome|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
293430|NCT01263444|E1|Reported Event|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
293431|NCT01263301|B3|Baseline|Total|Total of all reporting groups
293432|NCT01263301|B2|Baseline|Carotid Duplex for Hemodialytic Patients With SSS|After receiving written consent from patients with vascular access in the forearm, carotid duplex was done to especially see the flow pattern and direction of flow of vertebral artery and subclavian artery in the ipsilateral side of vascular access during and after the stop of flow in the arm by cuff test.
293433|NCT01263301|B1|Baseline|Carotid Duplex for Nonhemodialytic Patients Wtih SSS|using carotid duplex (with cuff test) to study vertebral and subclavian artery to see the difference of flow during and after occlusion of blood vessel in the arm by cuff test
293434|NCT01263301|P2|Participant Flow|Carotid Duplex for Hemodialytic Patients|"After receiving written consent from patients with vascular access in the forearm, carotid duplex was done to especially see the flow pattern and direction of vertebral artery and subclavian artery in the ipsilateral side of vascular access.~However, before carotid duplex, we didn't know which patients will show SSS.All 11 hemodialytic patients completed the study but only 2 showed the results of SSS. And for further analysis, we used these only 2."
293435|NCT01263301|P1|Participant Flow|Carotid Duplex for Nonhemidialytic Patients Wtih SSS|using carotid duplex to study vertebral and subclavian artery, using cuff test to see the difference of flow during and after occlusion of blood vessel in the arm by cuff test for patients in the two groups
293436|NCT01263301|O2|Outcome|Hemodialytic Patients With Subclavian Steal|we use carotid duplex to study vertebral arterial flow before and during cuff test that stopped the flow in arm to see how many patients with vascular access will have vertebral arterial flow remained unchanged during the test
293437|NCT01263301|O1|Outcome|Normal Parcipitants With Subclavian Steal|we use carotid duplex to study vertebral arterial flow before and during cuff test that stopped the flow in arm to see how many normal patients without vascular access will have vertebral arterial flow remained unchanged during the test
293438|NCT01263301|O2|Outcome|Hemodialytic Patients With Subclavian Steal|we use carotid duplex to study vertebral arterial flow before and during cuff test that stopped the flow in arm to see how many patients with vascular access will have vertebral arterial flow reversed to normal pattern during the test
293439|NCT01263301|O1|Outcome|Normal Parcipitants With Subclavian Steal|we use carotid duplex to study vertebral arterial flow before and during cuff test that stopped the flow in arm to see how many normal patients without vascular access will have vertebral arterial flow reversed to normal during the test
293440|NCT01263301|O2|Outcome|Hemodialytic Patients With Subclavian Steal|we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many patients with vascular access will have subclavian arterial flow remained unchanged during the cuff test
293441|NCT01263301|O1|Outcome|Normal Parcipitants With Subclavian Steal|we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many normal patients without vascular access will have subclavian arterial flow remained unchanged during the cuff test
293442|NCT01263301|O2|Outcome|Hemodialytic Patients With Subclavian Steal|we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many patients with vascular access will have subclavian arterial flow reversed to normal pattern during the test
293443|NCT01263301|O1|Outcome|Normal Parcipitants With Subclavian Steal|we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many normal patients without vascular access will have subclavian arterial flow reversed to normal during the test
293444|NCT01263301|E2|Reported Event|Carotid Duplex for Hemodialytic Patients With SSS|After receiving written consent from patients with vascular access in the forearm, carotid duplex was done to especially see the flow pattern and direction of flow of vertebral artery and subclavian artery in the ipsilateral side of vascular access during and after the stop of flow in the arm by cuff test.
293445|NCT01263301|E1|Reported Event|Carotid Duplex for Nonhemodialytic Patients Wtih SSS|using carotid duplex (with cuff test) to study vertebral and subclavian artery to see the difference of flow during and after occlusion of blood vessel in the arm by cuff test
293446|NCT01263132|B3|Baseline|Total|Total of all reporting groups
293447|NCT01263132|B2|Baseline|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
293448|NCT01263132|B1|Baseline|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
293449|NCT01263132|P2|Participant Flow|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
293450|NCT01263132|P1|Participant Flow|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
293451|NCT01263132|O2|Outcome|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
293452|NCT01263132|O1|Outcome|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
293453|NCT01263132|O2|Outcome|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
293454|NCT01263132|O1|Outcome|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
293455|NCT01263132|O2|Outcome|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
293456|NCT01263132|O1|Outcome|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
293457|NCT01263132|O2|Outcome|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
293458|NCT01263132|O1|Outcome|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
293459|NCT01263132|O2|Outcome|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
293460|NCT01263132|O1|Outcome|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
293461|NCT01263132|E2|Reported Event|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
293462|NCT01263132|E1|Reported Event|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
293463|NCT01263054|B3|Baseline|Total|Total of all reporting groups
293464|NCT01263054|B2|Baseline|Medical Management|"Standard medical management~Medical Management: Standard medical management, physical therapy, and lifestyle changes."
293465|NCT01263054|B1|Baseline|TransDiscal System|"Kimberly-Clark TransDiscal System in addition to standard medical management~TransDiscal System: Surgical Procedure using the TransDiscal System to perform disc biacuplasty."
293466|NCT01263054|P2|Participant Flow|Medical Management|"Standard medical management~Medical Management: Standard medical management, physical therapy, and lifestyle changes."
293467|NCT01263054|P1|Participant Flow|TransDiscal System|"Kimberly-Clark TransDiscal System in addition to standard medical management~TransDiscal System: Surgical Procedure using the TransDiscal System to perform disc biacuplasty."
293468|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
293469|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
293470|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
293471|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
293472|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
293473|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
293474|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
293475|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
293476|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
293477|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
293478|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
293479|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
293480|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
293481|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
293482|NCT01263054|E2|Reported Event|Medical Management|"Standard medical management~Medical Management: Standard medical management, physical therapy, and lifestyle changes."
293483|NCT01263054|E1|Reported Event|TransDiscal System|"Kimberly-Clark TransDiscal System in addition to standard medical management~TransDiscal System: Surgical Procedure using the TransDiscal System to perform disc biacuplasty."
293484|NCT01263028|B1|Baseline|Ergocalciferol Supplementation|
293485|NCT01263028|P1|Participant Flow|Ergocalciferol Supplementation|
293486|NCT01263028|O1|Outcome|Ergocalciferol Supplementation|Ergocalciferol will be administered as 50,000 international units (IU) weekly regardless of Serum 25-hydroxy Vitamin D levels for 12 weeks. Then 50,000 IU every other week. If 25-hydroxy Vitamin D levels are below goal of 40ng/ml, subjects will continue on 50,000 IU ergocalciferol weekly until levels of 40ng/ml, are achieved.
293487|NCT01263028|O1|Outcome|Ergocalciferol Supplementation|Ergocalciferol will be administered as 50,000 international units (IU) weekly regardless of Serum 25-hydroxy Vitamin D levels for 12 weeks. Then 50,000 IU every other week. If 25-hydroxy Vitamin D levels are below goal of 40ng/ml, subjects will continue on 50,000 IU ergocalciferol weekly until levels of 40ng/ml, are achieved.
293488|NCT01263028|O1|Outcome|Ergocalciferol Supplementation|Ergocalciferol will be administered as 50,000 international units (IU) weekly regardless of Serum 25-hydroxy Vitamin D levels for 12 weeks. Then 50,000 IU every other week. If 25-hydroxy Vitamin D levels are below goal of 40ng/ml, subjects will continue on 50,000 IU ergocalciferol weekly until levels of 40ng/ml, are achieved.
293524|NCT01262989|O2|Outcome|Reference Product|Reference product SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
294455|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
293489|NCT01263028|O1|Outcome|Ergocalciferol Supplementation|Ergocalciferol will be administered as 50,000 international units (IU) weekly regardless of Serum 25-hydroxy Vitamin D levels for 12 weeks. Then 50,000 IU every other week. If 25-hydroxy Vitamin D levels are below goal of 40ng/ml, subjects will continue on 50,000 IU ergocalciferol weekly until levels of 40ng/ml, are achieved.
293490|NCT01263028|O1|Outcome|Ergocalciferol Supplementation|Ergocalciferol will be administered as 50,000 international units (IU) weekly regardless of Serum 25-hydroxy Vitamin D levels for 12 weeks. Then 50,000 IU every other week. If 25-hydroxy Vitamin D levels are below goal of 40ng/ml, subjects will continue on 50,000 IU ergocalciferol weekly until levels of 40ng/ml, are achieved.
293491|NCT01263028|E1|Reported Event|Ergocalciferol Supplementation|
293492|NCT01263015|B3|Baseline|Total|Total of all reporting groups
293493|NCT01263015|B2|Baseline|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
293494|NCT01263015|B1|Baseline|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
293495|NCT01263015|P2|Participant Flow|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks.
293496|NCT01263015|P1|Participant Flow|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks.
293497|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
293498|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
293499|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
293500|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
293501|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
293502|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
293503|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
293504|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
293505|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
293506|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
293507|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
294456|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
293508|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
293509|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
293510|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
293511|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
293512|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
293513|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
293514|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
293515|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
293516|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
293517|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
293518|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
293519|NCT01263015|E2|Reported Event|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
293520|NCT01263015|E1|Reported Event|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
293521|NCT01262989|B1|Baseline|Participants Receiving Both Test Product and Reference Product|Participants receiving either test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days) or reference product in Period 1 and test product in Period 2
293522|NCT01262989|P2|Participant Flow|Reference Product in Period 1; Test Product in Period 2|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by a 7-day washout period during which no medication was administered; followed by test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days)
293523|NCT01262989|P1|Participant Flow|Test Product in Period 1; Reference Product in Period 2|Test product: tamsulosin hydrochloride 0.4 milligrams (mg) prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by a 7-day washout period during which no medication was administered; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days)
294457|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
293525|NCT01262989|O1|Outcome|Test Product|Test product tamsulosin hydrochloride 0.4 milligrams (mg) prolonged released hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
293526|NCT01262989|O2|Outcome|Reference Product|Reference product SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
293527|NCT01262989|O1|Outcome|Test Product|Test product tamsulosin hydrochloride 0.4 milligrams (mg) prolonged released hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
293528|NCT01262989|O2|Outcome|Reference Product|Reference product SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
293529|NCT01262989|O1|Outcome|Test Product|Test product tamsulosin hydrochloride 0.4 milligrams (mg) prolonged released hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
293530|NCT01262989|E2|Reported Event|Reference Product in Period 1; Test Product in Period 2|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by a 7-day washout period during which no medication was administered; followed by test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days)
293531|NCT01262989|E1|Reported Event|Test Product in Period 1; Reference Product in Period 2|Test product: tamsulosin hydrochloride 0.4 milligrams (mg) prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by a 7-day washout period during which no medication was administered; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days)
293532|NCT01262898|B5|Baseline|Total|Total of all reporting groups
293533|NCT01262898|B4|Baseline|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293534|NCT01262898|B3|Baseline|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293535|NCT01262898|B2|Baseline|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293536|NCT01262898|B1|Baseline|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293537|NCT01262898|P4|Participant Flow|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293538|NCT01262898|P3|Participant Flow|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293539|NCT01262898|P2|Participant Flow|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293540|NCT01262898|P1|Participant Flow|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293541|NCT01262898|O4|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293542|NCT01262898|O3|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293543|NCT01262898|O2|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293544|NCT01262898|O1|Outcome|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293545|NCT01262898|O4|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293546|NCT01262898|O3|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293547|NCT01262898|O2|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293548|NCT01262898|O1|Outcome|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293549|NCT01262898|O4|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293550|NCT01262898|O3|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293551|NCT01262898|O2|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293552|NCT01262898|O1|Outcome|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293553|NCT01262898|O4|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293554|NCT01262898|O3|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293555|NCT01262898|O2|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293556|NCT01262898|O1|Outcome|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293557|NCT01262898|O4|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293558|NCT01262898|O3|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293559|NCT01262898|O2|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293560|NCT01262898|O1|Outcome|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293561|NCT01262898|O3|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293562|NCT01262898|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293563|NCT01262898|O1|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293564|NCT01262898|O4|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293565|NCT01262898|O3|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293566|NCT01262898|O2|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293567|NCT01262898|O1|Outcome|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293568|NCT01262898|O3|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293569|NCT01262898|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293570|NCT01262898|O1|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293571|NCT01262898|O3|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293572|NCT01262898|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293573|NCT01262898|O1|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293574|NCT01262898|O3|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293575|NCT01262898|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293576|NCT01262898|O1|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293577|NCT01262898|O3|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293578|NCT01262898|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293579|NCT01262898|O1|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293580|NCT01262898|O3|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293581|NCT01262898|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293582|NCT01262898|O1|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293583|NCT01262898|O4|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293584|NCT01262898|O3|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293585|NCT01262898|O2|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293586|NCT01262898|O1|Outcome|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293587|NCT01262898|O4|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293588|NCT01262898|O3|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293589|NCT01262898|O2|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293590|NCT01262898|O1|Outcome|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293591|NCT01262898|O4|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293592|NCT01262898|O3|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293593|NCT01262898|O2|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293594|NCT01262898|O1|Outcome|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293595|NCT01262898|O4|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293596|NCT01262898|O3|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293597|NCT01262898|O2|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293598|NCT01262898|O1|Outcome|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293599|NCT01262898|O4|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293600|NCT01262898|O3|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293601|NCT01262898|O2|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293602|NCT01262898|O1|Outcome|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293603|NCT01262898|O4|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293604|NCT01262898|O3|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293605|NCT01262898|O2|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293606|NCT01262898|O1|Outcome|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293607|NCT01262898|O4|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293608|NCT01262898|O3|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293609|NCT01262898|O2|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293610|NCT01262898|O1|Outcome|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293611|NCT01262898|O4|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293612|NCT01262898|O3|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293613|NCT01262898|O2|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293614|NCT01262898|O1|Outcome|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293615|NCT01262898|O4|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293616|NCT01262898|O3|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293617|NCT01262898|O2|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293618|NCT01262898|O1|Outcome|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293619|NCT01262898|O4|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293620|NCT01262898|O3|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293621|NCT01262898|O2|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293622|NCT01262898|O1|Outcome|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293623|NCT01262898|O4|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293624|NCT01262898|O3|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293625|NCT01262898|O2|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293626|NCT01262898|O1|Outcome|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293627|NCT01262898|O4|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293628|NCT01262898|O3|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293629|NCT01262898|O2|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293630|NCT01262898|O1|Outcome|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293631|NCT01262898|O4|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293632|NCT01262898|O3|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293633|NCT01262898|O2|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293634|NCT01262898|O1|Outcome|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293635|NCT01262898|O4|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293636|NCT01262898|O3|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293637|NCT01262898|O2|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293638|NCT01262898|O1|Outcome|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293639|NCT01262898|O4|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293640|NCT01262898|O3|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293641|NCT01262898|O2|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293642|NCT01262898|O1|Outcome|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293643|NCT01262898|O4|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293644|NCT01262898|O3|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293645|NCT01262898|O2|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293646|NCT01262898|O1|Outcome|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293647|NCT01262898|O4|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293648|NCT01262898|O3|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293649|NCT01262898|O2|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293650|NCT01262898|O1|Outcome|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293651|NCT01262898|O4|Outcome|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293652|NCT01262898|O3|Outcome|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293653|NCT01262898|O2|Outcome|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293654|NCT01262898|O1|Outcome|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293655|NCT01262898|E4|Reported Event|GSK962040 125 mg|Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
293656|NCT01262898|E3|Reported Event|GSK962040 50 mg|Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
293657|NCT01262898|E2|Reported Event|GSK962040 10 mg|Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
293658|NCT01262898|E1|Reported Event|Placebo|Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
293659|NCT01262872|B9|Baseline|Total|Total of all reporting groups
293660|NCT01262872|B8|Baseline|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293661|NCT01262872|B7|Baseline|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293662|NCT01262872|B6|Baseline|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293663|NCT01262872|B5|Baseline|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293664|NCT01262872|B4|Baseline|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293665|NCT01262872|B3|Baseline|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293666|NCT01262872|B2|Baseline|Prevnar13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
293667|NCT01262872|B1|Baseline|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
293668|NCT01262872|P8|Participant Flow|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293696|NCT01262872|O1|Outcome|Total “All 5” Group|A subset of samples selected for ply and phtD gene sequencing of S. pneumoniae isolates, isolated from nasopharyngeal samples across all time points and across study groups of Cohort 2 (Prev13_3 group was excluded).
293669|NCT01262872|P7|Participant Flow|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293670|NCT01262872|P6|Participant Flow|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293671|NCT01262872|P5|Participant Flow|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293672|NCT01262872|P4|Participant Flow|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293673|NCT01262872|P3|Participant Flow|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293674|NCT01262872|P2|Participant Flow|Prevnar13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
293675|NCT01262872|P1|Participant Flow|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
293676|NCT01262872|O5|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293677|NCT01262872|O4|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293678|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
294001|NCT01262560|P2|Participant Flow|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
293679|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293680|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293681|NCT01262872|O5|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293682|NCT01262872|O4|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293683|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293684|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293685|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293686|NCT01262872|O5|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293697|NCT01262872|O1|Outcome|Total “All 5” Group|A subset of samples selected for ply and phtD gene sequencing of S. pneumoniae isolates, isolated from nasopharyngeal samples across all time points and across study groups of Cohort 2 (Prev13_3 group was excluded).
293892|NCT01262872|O2|Outcome|Prevnar13 1D Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
294002|NCT01262560|P1|Participant Flow|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
294458|NCT01261325|O3|Outcome|Placebo|Matching placebo tablets administered twice daily
293687|NCT01262872|O4|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293688|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293689|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293690|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293691|NCT01262872|O5|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293692|NCT01262872|O4|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293693|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293694|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293695|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
329281|NCT01174446|O1|Outcome|Prophylaxis|Study Part 2 Only
293698|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293699|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293700|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293701|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293702|NCT01262872|O2|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293703|NCT01262872|O1|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293704|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293705|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293706|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
329604|NCT01173471|P3|Participant Flow|Placebo BID|Placebo twice daily
293707|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293708|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293709|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293710|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293711|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293712|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293713|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293714|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293715|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
294003|NCT01262560|O3|Outcome|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
294459|NCT01261325|O2|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
293716|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293717|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293718|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293719|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293720|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293721|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293722|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293723|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293724|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293725|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293726|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293727|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293728|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293729|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293730|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293731|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293732|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293733|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
294004|NCT01262560|O2|Outcome|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
294460|NCT01261325|O1|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
293734|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293735|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293736|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293737|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293738|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293739|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293740|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293741|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293742|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293743|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293744|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293745|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293746|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293747|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293748|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293749|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293750|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293751|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
294005|NCT01262560|O1|Outcome|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
293752|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293753|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293754|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293755|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293756|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293757|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293758|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293759|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293760|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293761|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293762|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293763|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293764|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293765|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293766|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293767|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293768|NCT01262872|O4|Outcome|Prevnar 13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293769|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293770|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293771|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293772|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293773|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293774|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293775|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293776|NCT01262872|O4|Outcome|Prevnar 13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293777|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293778|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293779|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293780|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293781|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293782|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293783|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293784|NCT01262872|O4|Outcome|Prevnar 13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293785|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293786|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293787|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293788|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293789|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293790|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293791|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293792|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293793|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293794|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293795|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293796|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293797|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293798|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293799|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293800|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293801|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293802|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293803|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293804|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293805|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
294006|NCT01262560|O3|Outcome|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
294461|NCT01261325|E3|Reported Event|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
293806|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293807|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293808|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293809|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293810|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293811|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293812|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293813|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293814|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293815|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293816|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293817|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293818|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293819|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293820|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293821|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293822|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293823|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
294007|NCT01262560|O2|Outcome|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
294462|NCT01261325|E2|Reported Event|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
293824|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293825|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293826|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293827|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293828|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293829|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293830|NCT01262872|O2|Outcome|Synflorix 2+1D Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293831|NCT01262872|O1|Outcome|10PP-HD 2+1D Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293832|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293833|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293834|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally
293835|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293836|NCT01262872|O2|Outcome|Synflorix 2+1D Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293837|NCT01262872|O1|Outcome|10PP-HD 2+1D Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293838|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293839|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally
293840|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293841|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
294008|NCT01262560|O1|Outcome|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
293842|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293843|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293844|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293845|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293846|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293847|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293848|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293849|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293850|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293851|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293852|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293853|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293854|NCT01262872|O2|Outcome|Synflorix 2+1D Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293855|NCT01262872|O1|Outcome|10PP-HD 2+1D Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293856|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293857|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293858|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293859|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
294009|NCT01262560|O3|Outcome|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
294463|NCT01261325|E1|Reported Event|Placebo|Matching placebo tablets administered twice daily
293860|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293861|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293862|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293863|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293864|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293865|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293866|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293867|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293868|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293869|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293870|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293871|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293872|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293873|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293874|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293875|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293876|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293877|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
294010|NCT01262560|O2|Outcome|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
294545|NCT01260883|O2|Outcome|Placebo|infants given placebo intravenously after surgery
293878|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293879|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293880|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293881|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293882|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293883|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293884|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
293885|NCT01262872|O1|Outcome|10PP-HD 1d|Group This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
293886|NCT01262872|O2|Outcome|Prevnar13 1D Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
293887|NCT01262872|O1|Outcome|10PP-HD 1D Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
293888|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
293889|NCT01262872|O1|Outcome|10PP-HD 1d|Group This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
293890|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
293891|NCT01262872|O1|Outcome|10PP-HD 1d|Group This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
293893|NCT01262872|O1|Outcome|10PP-HD 1D Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
293894|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
293895|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
293896|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
293897|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
293898|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
293899|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
293900|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
293901|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
293902|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
293903|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
293904|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
293905|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
293906|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293907|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293908|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293946|NCT01262755|E1|Reported Event|African Americans|"Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80.~Structured Interview: Subjects underwent a structured interview using a laptop computer and answered over 200 standardized questions. All patient had their height, weight, and waist circumference measured."
293947|NCT01262651|B3|Baseline|Total|Total of all reporting groups
294011|NCT01262560|O1|Outcome|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
293909|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293910|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293911|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
293912|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
293913|NCT01262872|O2|Outcome|Prevnar13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
293914|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
293915|NCT01262872|O2|Outcome|Prevnar13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
293916|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
293917|NCT01262872|O2|Outcome|Prevnar13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
293918|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
293919|NCT01262872|E8|Reported Event|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293920|NCT01262872|E7|Reported Event|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293921|NCT01262872|E6|Reported Event|Prevnar 13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293948|NCT01262651|B2|Baseline|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol: propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
293968|NCT01262651|O2|Outcome|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
293922|NCT01262872|E5|Reported Event|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293923|NCT01262872|E4|Reported Event|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293924|NCT01262872|E3|Reported Event|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
293925|NCT01262872|E2|Reported Event|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
293926|NCT01262872|E1|Reported Event|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
293927|NCT01262846|B3|Baseline|Total|Total of all reporting groups
293928|NCT01262846|B2|Baseline|Fluzone® High Dose|"Fluzone® High dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject’s deltoid muscles.~Fluzone®: Fluzone® High dose or Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles."
293929|NCT01262846|B1|Baseline|Fluzone SD|"Fluzone® Standard dose~Fluzone®: Fluzone® Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles."
293930|NCT01262846|P2|Participant Flow|Fluzone® High Dose|"Fluzone® High dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject’s deltoid muscles.~Fluzone®: Fluzone® High dose or Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles."
293931|NCT01262846|P1|Participant Flow|Fluzone SD|"Fluzone® Standard dose~Fluzone®: Fluzone® Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles."
293932|NCT01262846|O2|Outcome|HD Recipients|Fluzone High Dose
293933|NCT01262846|O1|Outcome|SD Recipients|Fluzone Regular Dose
293934|NCT01262846|E2|Reported Event|HD Recipients|
293935|NCT01262846|E1|Reported Event|SD Recipients|
293936|NCT01262820|B1|Baseline|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study~Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
293937|NCT01262820|P1|Participant Flow|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study~Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
293938|NCT01262820|O1|Outcome|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study~Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
293939|NCT01262820|O1|Outcome|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study~Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
293940|NCT01262820|O1|Outcome|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study~Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
293941|NCT01262820|O1|Outcome|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study~Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
293942|NCT01262820|E1|Reported Event|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study~Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
293943|NCT01262755|B1|Baseline|African Americans|"Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80.~Structured Interview: Subjects underwent a structured interview using a laptop computer and answered over 200 standardized questions. All patient had their height, weight, and waist circumference measured."
293944|NCT01262755|P1|Participant Flow|African Americans|"Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80.~Structured Interview: Subjects underwent a structured interview using a laptop computer and answered over 200 standardized questions. All patient had their height, weight, and waist circumference measured."
293945|NCT01262755|O1|Outcome|African Americans|"Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80.~Structured Interview: Subjects underwent a structured interview using a laptop computer and answered over 200 standardized questions. All patient had their height, weight, and waist circumference measured."
293998|NCT01262560|B2|Baseline|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
293999|NCT01262560|B1|Baseline|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
293949|NCT01262651|B1|Baseline|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
293950|NCT01262651|P2|Participant Flow|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol: propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
293951|NCT01262651|P1|Participant Flow|Nabiximols|Nabiximols was self-administered by participants as a 100 microliter (μL) oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained delta-9-tetrahydrocannabinol (THC) (27 milligram [mg]/milliliter [mL]):cannabidiol (CBD) (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
293952|NCT01262651|O2|Outcome|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
293953|NCT01262651|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
293954|NCT01262651|O2|Outcome|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
293955|NCT01262651|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
293956|NCT01262651|O2|Outcome|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
293957|NCT01262651|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
293958|NCT01262651|O2|Outcome|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
293959|NCT01262651|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
293960|NCT01262651|O2|Outcome|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
293961|NCT01262651|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
293962|NCT01262651|O2|Outcome|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
293963|NCT01262651|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
293964|NCT01262651|O2|Outcome|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
293965|NCT01262651|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
293966|NCT01262651|O2|Outcome|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
293967|NCT01262651|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
294000|NCT01262560|P3|Participant Flow|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
293969|NCT01262651|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
293970|NCT01262651|O2|Outcome|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
293971|NCT01262651|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
293972|NCT01262651|O2|Outcome|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
293973|NCT01262651|O1|Outcome|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
293974|NCT01262651|E2|Reported Event|Placebo (GA-0034)|Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.
293975|NCT01262651|E1|Reported Event|Nabiximols|Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
293976|NCT01262599|B3|Baseline|Total|Total of all reporting groups
293977|NCT01262599|B2|Baseline|PEMF Device|"Ivivi Torino II PEMF Device: The PEMF device to be employed in this study is FDA cleared for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours."
293978|NCT01262599|B1|Baseline|Sham PEMF Device|Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
293979|NCT01262599|P2|Participant Flow|PEMF Device|"Ivivi Torino II PEMF Device: The PEMF device to be employed in this study is FDA cleared for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours."
293980|NCT01262599|P1|Participant Flow|Sham PEMF Device|Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
293981|NCT01262599|O2|Outcome|PEMF Device|"Ivivi Torino II PEMF Device: The PEMF device to be employed in this study is FDA cleared for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours."
293982|NCT01262599|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
293983|NCT01262599|E2|Reported Event|PEMF Device|"Ivivi Torino II PEMF Device: The PEMF device to be employed in this study is FDA cleared for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours."
293984|NCT01262599|E1|Reported Event|Sham PEMF Device|Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
293985|NCT01262573|B3|Baseline|Total|Total of all reporting groups
293986|NCT01262573|B2|Baseline|Smooth|"Vaginal cuff closure with smooth suture~Closure of vaginal cuff: Closure of the vaginal cuff"
293987|NCT01262573|B1|Baseline|Barbed|"Vaginal cuff closure with barbed suture~Closure of vaginal cuff: Closure of the vaginal cuff"
293988|NCT01262573|P2|Participant Flow|Smooth|"Vaginal cuff closure with smooth suture~Closure of vaginal cuff: Closure of the vaginal cuff"
293989|NCT01262573|P1|Participant Flow|Barbed|"Vaginal cuff closure with barbed suture~Closure of vaginal cuff: Closure of the vaginal cuff"
293990|NCT01262573|O2|Outcome|Smooth|"Vaginal cuff closure with smooth suture~Closure of vaginal cuff: Closure of the vaginal cuff"
293991|NCT01262573|O1|Outcome|Barbed|"Vaginal cuff closure with barbed suture~Closure of vaginal cuff: Closure of the vaginal cuff"
293992|NCT01262573|O2|Outcome|Smooth|"Vaginal cuff closure with smooth suture~Closure of vaginal cuff: Closure of the vaginal cuff"
293993|NCT01262573|O1|Outcome|Barbed|"Vaginal cuff closure with barbed suture~Closure of vaginal cuff: Closure of the vaginal cuff"
293994|NCT01262573|E2|Reported Event|Smooth|"Vaginal cuff closure with smooth suture~Closure of vaginal cuff: Closure of the vaginal cuff"
293995|NCT01262573|E1|Reported Event|Barbed|"Vaginal cuff closure with barbed suture~Closure of vaginal cuff: Closure of the vaginal cuff"
293996|NCT01262560|B4|Baseline|Total|Total of all reporting groups
293997|NCT01262560|B3|Baseline|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
294546|NCT01260883|O1|Outcome|Ketorolac 1 or 0.5 mg/kg|infants given ketorolac intravenously after surgery
294012|NCT01262560|O3|Outcome|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
294013|NCT01262560|O2|Outcome|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
294014|NCT01262560|O1|Outcome|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
294015|NCT01262560|O3|Outcome|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
294016|NCT01262560|O2|Outcome|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
294017|NCT01262560|O1|Outcome|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
294018|NCT01262560|O3|Outcome|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
294019|NCT01262560|O2|Outcome|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
294020|NCT01262560|O1|Outcome|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
294021|NCT01262560|O3|Outcome|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
294022|NCT01262560|O2|Outcome|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
294023|NCT01262560|O1|Outcome|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
294024|NCT01262560|O3|Outcome|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
294025|NCT01262560|O2|Outcome|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
294026|NCT01262560|O1|Outcome|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
294027|NCT01262560|O3|Outcome|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
294028|NCT01262560|O2|Outcome|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
294029|NCT01262560|O1|Outcome|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
294030|NCT01262560|O3|Outcome|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
294031|NCT01262560|O2|Outcome|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
294032|NCT01262560|O1|Outcome|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
294033|NCT01262560|E3|Reported Event|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
294034|NCT01262560|E2|Reported Event|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
294035|NCT01262560|E1|Reported Event|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
294036|NCT01262547|B1|Baseline|All Study Participants|"Dermabrasion-Micrografting, Dermabrasion and Control~Dermabrasion-Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis).~Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline.~Control: Untreated depigmented area"
294037|NCT01262547|P1|Participant Flow|Patients With Vitiligo|Three subjects with vitiligo were recruited for the study. All subjects had three test sites that were studied. One site received dermabrasion and micrografting, one site received dermabrasion alone and one site was not treated and served as the control.
294038|NCT01262547|O3|Outcome|Control|Control
294039|NCT01262547|O2|Outcome|Dermabrasion Alone|"Dermabrasion alone~Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline."
294040|NCT01262547|O1|Outcome|Dermabrasion-Micrografting|"Dermabrasion-Micrografting~Dermabrasion-Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis)."
294041|NCT01262547|O3|Outcome|Control|Target sites did not receive any treatment
294042|NCT01262547|O2|Outcome|Dermabrasion Alone|"Dermabrasion alone~Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline."
294043|NCT01262547|O1|Outcome|Dermabrasion-Micrografting|"Dermabrasion-Micrografting~Dermabrasion-Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis)."
294044|NCT01262547|E3|Reported Event|Control|"Control~Depigmented areas that did not receive any treatment."
294045|NCT01262547|E2|Reported Event|Dermabrasion Alone|"Dermabrasion alone~Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline."
294046|NCT01262547|E1|Reported Event|Dermabrasion-Micrografting|"Dermabrasion-Micrografting~Dermabrasion-Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis)."
294047|NCT01262456|B4|Baseline|Total|Total of all reporting groups
294048|NCT01262456|B3|Baseline|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294049|NCT01262456|B2|Baseline|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294050|NCT01262456|B1|Baseline|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294051|NCT01262456|P3|Participant Flow|Desmopressin 75 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for the 1-month open-label extension period.
294052|NCT01262456|P2|Participant Flow|50 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for the 1-month open-label extension period.
294053|NCT01262456|P1|Participant Flow|Placebo Double-Blind / Desmopressin 100 μg Open-Label|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for the 1-month open-label extension period.
294054|NCT01262456|O3|Outcome|Desmopressin 75 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
294055|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
294056|NCT01262456|O1|Outcome|Placebo Double-Blind / Desmopressin 100 μg Open-Label|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
294057|NCT01262456|O3|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294058|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294059|NCT01262456|O1|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294060|NCT01262456|O3|Outcome|Desmopressin 75 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
294061|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
294062|NCT01262456|O1|Outcome|Placebo Double-Blind / Desmopressin 100 μg Open-Label|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
294063|NCT01262456|O3|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294064|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294065|NCT01262456|O1|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294066|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294067|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294068|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294069|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294070|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294071|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294072|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294073|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294074|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294547|NCT01260883|O2|Outcome|Placebo|infants receiving placebo infusion intravenously after surgery
294075|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294076|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294077|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294078|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294079|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294080|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294081|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294082|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294083|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294084|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294085|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294086|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294087|NCT01262456|E6|Reported Event|Placebo Double-Blind / Desmopressin 100 μg Open-Label|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
294088|NCT01262456|E5|Reported Event|Desmopressin 75 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
294089|NCT01262456|E4|Reported Event|Desmopressin 50 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
294090|NCT01262456|E3|Reported Event|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294091|NCT01262456|E2|Reported Event|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294092|NCT01262456|E1|Reported Event|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
294093|NCT01262352|B3|Baseline|Total|Total of all reporting groups
294094|NCT01262352|B2|Baseline|Placebo Then Ivacaftor|Placebo administered in Treatment Period 1 and ivacaftor administered in Treatment Period 2.
294095|NCT01262352|B1|Baseline|Ivacaftor Then Placebo|Ivacaftor administered in Treatment Period 1 and placebo administered in Treatment Period 2.
294096|NCT01262352|P2|Participant Flow|Placebo Then Ivacaftor|Placebo administered in Treatment Period 1 and ivacaftor administered in Treatment Period 2.
294097|NCT01262352|P1|Participant Flow|Ivacaftor Then Placebo|Ivacaftor administered in Treatment Period 1 and placebo administered in Treatment Period 2.
294098|NCT01262352|O2|Outcome|Ivacaftor|Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
294099|NCT01262352|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 28 days.
294100|NCT01262352|O2|Outcome|Ivacaftor|Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
294101|NCT01262352|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 28 days.
294102|NCT01262352|O2|Outcome|Ivacaftor|Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
294103|NCT01262352|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 28 days.
294104|NCT01262352|O2|Outcome|Ivacaftor|Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
294105|NCT01262352|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 28 days.
294106|NCT01262352|E2|Reported Event|Ivacaftor|Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
294107|NCT01262352|E1|Reported Event|Placebo|Oral tablet every 12 hours (q12h) for up to 28 days.
294108|NCT01262339|B1|Baseline|Comparator of Hand A Intervention vs Hand B|"Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.~BTX-A: 100 units of BTX-A will be delivered subject’s hand via iontophoresis and standard of care intradermal injection of 100 units BTX-A will be delivered to the contra-lateral hand"
294148|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
294109|NCT01262339|P1|Participant Flow|Comparator of Hand A Intervention vs Hand B|"Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.~BTX-A: 100 units of BTX-A will be delivered subject’s hand via iontophoresis and standard of care intradermal injection of 100 units BTX-A will be delivered to the contra-lateral hand"
294110|NCT01262339|O1|Outcome|Active Comparator: Comparator of Hand A Intervention vs Hand B|Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.
294111|NCT01262339|E1|Reported Event|Comparator of Hand A Intervention vs Hand B|"Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.~BTX-A: 100 units of BTX-A will be delivered subject’s hand via iontophoresis and standard of care intradermal injection of 100 units BTX-A will be delivered to the contra-lateral hand"
294112|NCT01262287|B3|Baseline|Total|Total of all reporting groups
294113|NCT01262287|B2|Baseline|Placebo|"placebo daily for 8-week treatment period~placebo: placebo capsules in same number as active drug, daily for 8-week treatment period"
294114|NCT01262287|B1|Baseline|Dutasteride|"dutasteride (1 mg oral daily dose) for 8-week treatment period~Dutasteride: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period"
294115|NCT01262287|P2|Participant Flow|Placebo|"placebo daily for 8-week treatment period~placebo: placebo capsules in same number as active drug, daily for 8-week treatment period"
294116|NCT01262287|P1|Participant Flow|Dutasteride|"dutasteride (1 mg oral daily dose) for 8-week treatment period~Dutasteride: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period"
294117|NCT01262287|O4|Outcome|AKR1C3*2 G-carriers + Placebo|AKR1C3*2 G-carriers in placebo arm
294118|NCT01262287|O3|Outcome|AKR1C3*2 G-carriers + Dutasteride|AKR1C3*2 G-carriers in dutasteride arm (1 mg/day x 8 wks)
294119|NCT01262287|O2|Outcome|AKR1C3*2 C/C Genotype + Placebo|"AKR1C3*2 C/C genotype subjects in placebo arm~placebo: placebo capsules in same number as active drug, daily for 8-week treatment period"
294120|NCT01262287|O1|Outcome|AKR1C3*2 C/C Genotype + Dutasteride|AKR1C3*2 C/C genotype subjects in dutasteride arm (1 mg daily for 8 wks)
294121|NCT01262287|O2|Outcome|Placebo|"placebo daily for 8-week treatment period~placebo: placebo capsules in same number as active drug, daily for 8-week treatment period"
294122|NCT01262287|O1|Outcome|Dutasteride|"dutasteride (1 mg oral daily dose) for 8-week treatment period~Dutasteride: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period"
294123|NCT01262287|E2|Reported Event|Placebo|"placebo daily for 8-week treatment period~placebo: placebo capsules in same number as active drug, daily for 8-week treatment period"
294124|NCT01262287|E1|Reported Event|Dutasteride|"dutasteride (1 mg oral daily dose) for 8-week treatment period~Dutasteride: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period"
294125|NCT01262131|B4|Baseline|Total|Total of all reporting groups
294126|NCT01262131|B3|Baseline|Inactive Resonator|Application of inactive magnetic fields using the Resonator device
294127|NCT01262131|B2|Baseline|Resonator Protocol B|Application of magnetic fields using the Resonator device treatment protocol B
294128|NCT01262131|B1|Baseline|Resonator Protocol A|Application of magnetic fields using the Resonator device protocol A
294129|NCT01262131|P3|Participant Flow|Inactive Resonator|Application of inactive magnetic fields using the Resonator device
294130|NCT01262131|P2|Participant Flow|Resonator Protocol B|Application of magnetic fields using the Resonator device treatment protocol B
294131|NCT01262131|P1|Participant Flow|Resonator Protocol A|Application of magnetic fields using the Resonator device protocol A
294132|NCT01262131|O3|Outcome|Inactive Resonator|Application of inactive magnetic fields using the Resonator device
294133|NCT01262131|O2|Outcome|Resonator Protocol B|Application of magnetic fields using the Resonator device treatment protocol B
294134|NCT01262131|O1|Outcome|Resonator Protocol A|Application of magnetic fields using the Resonator device protocol A
294135|NCT01262131|E3|Reported Event|Inactive Resonator|Application of inactive magnetic fields using the Resonator device
294136|NCT01262131|E2|Reported Event|Resonator Protocol B|Application of magnetic fields using the Resonator device treatment protocol B
294137|NCT01262131|E1|Reported Event|Resonator Protocol A|Application of magnetic fields using the Resonator device protocol A
294138|NCT01262118|B3|Baseline|Total|Total of all reporting groups
294139|NCT01262118|B2|Baseline|Healthy Volunteers Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
294140|NCT01262118|B1|Baseline|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
294141|NCT01262118|P2|Participant Flow|Healthy Volunteers Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
294142|NCT01262118|P1|Participant Flow|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
294143|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
294144|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
294145|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
294146|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
294147|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
294149|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
294150|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
294151|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
294152|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
294153|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
294154|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
294155|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
294156|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
294157|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
294158|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
294159|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
294160|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
294161|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
294162|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
294163|NCT01262118|E2|Reported Event|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
294164|NCT01262118|E1|Reported Event|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
294165|NCT01262105|B3|Baseline|Total|Total of all reporting groups
294166|NCT01262105|B2|Baseline|Device Deployed|
294167|NCT01262105|B1|Baseline|No Device|
294168|NCT01262105|P2|Participant Flow|Device Deployed|
294169|NCT01262105|P1|Participant Flow|No Device|
294170|NCT01262105|O2|Outcome|Device Deployed|The ABS device is employed during surgery.
294171|NCT01262105|O1|Outcome|No Device|No device is deployed during surgery
294172|NCT01262105|E2|Reported Event|Device Deployed|
294173|NCT01262105|E1|Reported Event|No Device|
294174|NCT01262092|B3|Baseline|Total|Total of all reporting groups
294175|NCT01262092|B2|Baseline|Placebo|Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
294176|NCT01262092|B1|Baseline|Gabapentin|Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
294177|NCT01262092|P2|Participant Flow|Placebo|Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
294178|NCT01262092|P1|Participant Flow|Gabapentin|Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
294179|NCT01262092|O2|Outcome|Placebo|Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
294180|NCT01262092|O1|Outcome|Gabapentin|Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
294181|NCT01262092|E2|Reported Event|Placebo|Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
294182|NCT01262092|E1|Reported Event|Gabapentin|Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
294183|NCT01262027|B1|Baseline|Dovitinib|Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
294184|NCT01262027|P1|Participant Flow|Dovitinib|Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
294185|NCT01262027|O1|Outcome|Dovitinib|Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
294186|NCT01262027|O1|Outcome|Dovitinib|Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
294187|NCT01262027|E1|Reported Event|Dovitinib|Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
294188|NCT01261975|B1|Baseline|Cataract Surgery|Cataract surgery with phacoemulsification using the Stellaris Vision Enhancement System
294189|NCT01261975|P1|Participant Flow|Cataract Surgery|Cataract surgery with phacoemulsification. Eligible patients were randomized to undergo cataract surgery using the 1.8 mm coaxial micro incision technique in either the right eye or the left eye. The fellow eye was assigned to undergo cataract surgery using the 2.75 mm standard incision. The Stellaris Vision Enhancement System was used for the surgery.
294190|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
294191|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
294192|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
294193|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
294194|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
294195|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
294196|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
294197|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
294198|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
294199|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
294200|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
294201|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
294202|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
294203|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
294204|NCT01261975|E3|Reported Event|Cataract Surgery All Participants|Events by participant one eye with 1.8 mm coaxial micro-incision cataract surgery (C-MICS) and the contralateral eye with the 2.75 mm coaxial standard cataract surgery.
294205|NCT01261975|E2|Reported Event|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
294206|NCT01261975|E1|Reported Event|Co-Axial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System.
294207|NCT01261780|B3|Baseline|Total|Total of all reporting groups
294208|NCT01261780|B2|Baseline|MC-5A Treatment|"MC-5A therapy to the area of painful CIPN for 45 minutes daily for a total of 10 days.~MC-5A: 45 minutes daily x 10 treatments (given over the course of 2 weeks)"
294209|NCT01261780|B1|Baseline|Sham Device|"Sham therapy device to area of painful chemotherapy induced peripheral neuropathy (CIPN) for 45 minutes daily x 10 days~Sham device: Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)"
294210|NCT01261780|P2|Participant Flow|MC-5A Treatment|"MC-5A therapy to the area of painful CIPN for 45 minutes daily for a total of 10 days.~MC-5A: 45 minutes daily x 10 treatments (given over the course of 2 weeks)"
294211|NCT01261780|P1|Participant Flow|Sham Device|"Sham therapy device to area of painful chemotherapy induced peripheral neuropathy (CIPN) for 45 minutes daily x 10 days~Sham device: Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)"
294212|NCT01261780|O2|Outcome|MC-5A Treatment|"MC-5A therapy to the area of painful CIPN for 45 minutes daily for a total of 10 days.~MC-5A: 45 minutes daily x 10 treatments (given over the course of 2 weeks)"
294213|NCT01261780|O1|Outcome|Sham Device|"Sham therapy device to area of painful chemotherapy induced peripheral neuropathy (CIPN) for 45 minutes daily x 10 days~Sham device: Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)"
294214|NCT01261780|O2|Outcome|MC-5A Treatment|"MC-5A therapy to the area of painful CIPN for 45 minutes daily for a total of 10 days.~MC-5A: 45 minutes daily x 10 treatments (given over the course of 2 weeks)"
294215|NCT01261780|O1|Outcome|Sham Device|"Sham therapy device to area of painful chemotherapy induced peripheral neuropathy (CIPN) for 45 minutes daily x 10 days~Sham device: Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)"
294216|NCT01261780|E2|Reported Event|MC-5A Treatment|"MC-5A therapy to the area of painful CIPN for 45 minutes daily for a total of 10 days.~MC-5A: 45 minutes daily x 10 treatments (given over the course of 2 weeks)"
294217|NCT01261780|E1|Reported Event|Sham Device|"Sham therapy device to area of painful chemotherapy induced peripheral neuropathy (CIPN) for 45 minutes daily x 10 days~Sham device: Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)"
294218|NCT01261624|B3|Baseline|Total|Total of all reporting groups
294219|NCT01261624|B2|Baseline|High Dose Treatment Cohort (HDTC): 0.75 mg/kg BID|Patient received the dose of 0.75 mg/kg for 12 weeks in fed condition
294220|NCT01261624|B1|Baseline|Low Dose Treatment Cohort (LDTC): 0.50 mg/kg BID|Patient received the dose of 0.50 mg/kg for 12 weeks in fed condition
294221|NCT01261624|P2|Participant Flow|High Dose Treatment Cohort (HDTC): 0.75 mg/kg BID|Patients received the dose of 0.75 mg/kg BID for 12 weeks in fed conditions
294222|NCT01261624|P1|Participant Flow|Low Dose Treatment Cohort (LDTC): 0.50 mg/kg Twice Daily (BID)|Patients (pts) received the dose of 0.50 mg/kg BID for 12 weeks in fed condition
294541|NCT01260883|O1|Outcome|S- Ketorolac Volume Distribution Central|stereo-specific ketorolac analysis by NONMEM
294223|NCT01261624|O5|Outcome|High Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; four patients discontinued the study (High Dose Discontinued treatment cohort
294224|NCT01261624|O4|Outcome|High Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; two patients continued the same dose throughout the study (High Dose Throughout treatment cohort)
294225|NCT01261624|O3|Outcome|Switched Dose|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort, 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, 3 of them switched to the high dose at the Investigator’s decision for further 12 weeks agreed by the Sponsor (Switched Dose treatment cohort).
294226|NCT01261624|O2|Outcome|Low Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, one of them continued the same dose for further 12 weeks (Low Dose Throughout treatment cohort)
294227|NCT01261624|O1|Outcome|Low Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 pts enrolled to initial Low Dose treatment cohort (LD), 1 pt discontinued the study before wk 12 (Low Dose Discontinued treatment cohort).
294228|NCT01261624|O5|Outcome|High Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; four patients discontinued the study (High Dose Discontinued treatment cohort
294229|NCT01261624|O4|Outcome|High Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; two patients continued the same dose throughout the study (High Dose Throughout treatment cohort)
294230|NCT01261624|O3|Outcome|Switched Dose|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort, 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, 3 of them switched to the high dose at the Investigator’s decision for further 12 weeks agreed by the Sponsor (Switched Dose treatment cohort).
294231|NCT01261624|O2|Outcome|Low Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, one of them continued the same dose for further 12 weeks (Low Dose Throughout treatment cohort)
294232|NCT01261624|O1|Outcome|Low Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 pts enrolled to initial Low Dose treatment cohort (LD), 1 pt discontinued the study before wk 12 (Low Dose Discontinued treatment cohort).
294233|NCT01261624|E5|Reported Event|High Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; four patients discontinued the study (High Dose Discontinued treatment cohort
294234|NCT01261624|E4|Reported Event|High Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; two patients continued the same dose throughout the study (High Dose Throughout treatment cohort)
294235|NCT01261624|E3|Reported Event|Switched Dose|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort, 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, 3 of them switched to the high dose at the Investigator’s decision for further 12 weeks agreed by the Sponsor (Switched Dose treatment cohort). Safety data selected for high and low dose in this cohort are not available, this kind of analysis has not been performed.
294236|NCT01261624|E2|Reported Event|Low Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, one of them continued the same dose for further 12 weeks (Low Dose Throughout treatment cohort)
294237|NCT01261624|E1|Reported Event|Low Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 pts enrolled to initial Low Dose treatment cohort (LD), 1 pt discontinued the study before wk 12 (Low Dose Discontinued treatment cohort).
294238|NCT01261559|B3|Baseline|Total|Total of all reporting groups
294239|NCT01261559|B2|Baseline|Chrysalis CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.
294240|NCT01261559|B1|Baseline|Standard CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.
294241|NCT01261559|P2|Participant Flow|Chrysalis CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.
294242|NCT01261559|P1|Participant Flow|Standard CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.
294243|NCT01261559|O2|Outcome|Chrysalis CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.
294244|NCT01261559|O1|Outcome|Standard CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.
294542|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
294245|NCT01261559|O2|Outcome|Chrysalis CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.
294246|NCT01261559|O1|Outcome|Standard CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.
294247|NCT01261559|E2|Reported Event|Chrysalis CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.
294248|NCT01261559|E1|Reported Event|Standard CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.
294249|NCT01261507|B1|Baseline|Radiologists|Board Certified Radiologists working in the Washington, DC, Baltimore region
294250|NCT01261507|P1|Participant Flow|Board Certified Radiologists|15 Board Certified radiologists were recruited from non-University sites. Each served as subject and control is a crossover design
294251|NCT01261507|O2|Outcome|Radiologists Working With Software|radiologists interpret the images using the experimental software
294252|NCT01261507|O1|Outcome|Radiologists Working Without Software|Radiologists interpret the same images without the use of software
294253|NCT01261507|O2|Outcome|Radiologists Working With Software|radiologists interpret the images using the experimental software
294254|NCT01261507|O1|Outcome|Radiologists Working Without Software|Radiologists interpret the same images without the use of software
294255|NCT01261507|O2|Outcome|Radiologists Working With Software|Each radiologist serves as own control, working without and with software. This is the arm working with software
294256|NCT01261507|O1|Outcome|Board Certified Radiologists Working Without Software|15 Board Certified radiologists were recruited from non-University sites. Each served as subject and control is a crossover design
294257|NCT01261507|E1|Reported Event|Board Certified Radiologists|15 Board Certified radiologists were recruited from non-University sites. Each served as subject and control is a crossover design
294258|NCT01261390|B5|Baseline|Total|Total of all reporting groups
294259|NCT01261390|B4|Baseline|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294260|NCT01261390|B3|Baseline|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294261|NCT01261390|B2|Baseline|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294262|NCT01261390|B1|Baseline|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294263|NCT01261390|P4|Participant Flow|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294264|NCT01261390|P3|Participant Flow|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294265|NCT01261390|P2|Participant Flow|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294277|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294266|NCT01261390|P1|Participant Flow|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294267|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294268|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294269|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294270|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294271|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294272|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294273|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294274|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294275|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294276|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294464|NCT01261247|B1|Baseline|Arm I (LBH589)|Patients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
294278|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294279|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294280|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294281|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294282|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294283|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294284|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294285|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294286|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294287|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294288|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294465|NCT01261247|P1|Participant Flow|Arm I (LBH589)|Patients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
294289|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294290|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294291|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294292|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294293|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294294|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294295|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294296|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294297|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294298|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294299|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294466|NCT01261247|O1|Outcome|Arm I (LBH589)|Patients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
294467|NCT01261247|O1|Outcome|Arm I (LBH589)|Patients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
294300|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294301|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294302|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294303|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294304|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294305|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294306|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294307|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294308|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294309|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294310|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294333|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294311|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294312|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294313|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294314|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294315|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294316|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294317|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294318|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294319|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294320|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294321|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294345|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294543|NCT01260883|O2|Outcome|R+ Ketorolac Clearance|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
294322|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294323|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294324|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294325|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294326|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294327|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294328|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294329|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294330|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294331|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294332|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294468|NCT01261247|O1|Outcome|Arm I (LBH589)|Patients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
294334|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294335|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294336|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294337|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294338|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294339|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294340|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294341|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294342|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294343|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294344|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294469|NCT01261247|O1|Outcome|Arm I (LBH589)|Patients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
294346|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294347|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294348|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294349|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294350|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294351|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294352|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294353|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294354|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294355|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294356|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294470|NCT01261247|E1|Reported Event|Arm I (LBH589)|Patients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
294357|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294358|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294359|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294360|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294361|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294362|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294363|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294364|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294365|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294366|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294367|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294494|NCT01260922|B1|Baseline|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
294544|NCT01260883|O1|Outcome|S- Ketorolac Clearance|stereo-specific ketorolac analysis by NONMEM
294368|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294369|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294370|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294371|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294372|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294373|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294374|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294375|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294376|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294377|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294378|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294401|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294379|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294380|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294381|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294382|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294383|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294384|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294385|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294386|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294387|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294388|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294389|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294447|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
294448|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
294449|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
294450|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
294451|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
294390|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294391|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294392|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294393|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294394|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294395|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294396|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294397|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294398|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294399|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294400|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294452|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
294453|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
294402|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294403|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294404|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294405|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294406|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294407|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294408|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294409|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294410|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294411|NCT01261390|O2|Outcome|Active Treatment Arms (Pooled)|Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.
294412|NCT01261390|O1|Outcome|Control Arms (Pooled)|Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.
294413|NCT01261390|O2|Outcome|Active Treatment Arms (Pooled)|Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.
294414|NCT01261390|O1|Outcome|Control Arms (Pooled)|Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.
294415|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294416|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294417|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294418|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294419|NCT01261390|O2|Outcome|Active PAP With Motivational Enhancement|Participants randomly assigned to Active PAP with Behavioral Modification arm (Active+Beh).
294420|NCT01261390|O1|Outcome|Active PAP With RT Support Only|Participants randomly assigned to either the Active PAP with RT Support arm (ActiveBeh).
294421|NCT01261390|O2|Outcome|Active Treatment Arms (Pooled)|Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.
294422|NCT01261390|O1|Outcome|Control Arms (Pooled)|Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.
294423|NCT01261390|E4|Reported Event|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
294424|NCT01261390|E3|Reported Event|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
294425|NCT01261390|E2|Reported Event|Sham PAP (Sham)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
294426|NCT01261390|E1|Reported Event|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
294427|NCT01261325|B4|Baseline|Total Title|
294428|NCT01261325|B3|Baseline|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
294429|NCT01261325|B2|Baseline|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
294430|NCT01261325|B1|Baseline|Placebo|Matching placebo tablets administered twice daily
294431|NCT01261325|P3|Participant Flow|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
294432|NCT01261325|P2|Participant Flow|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
294433|NCT01261325|P1|Participant Flow|Placebo|Matching placebo tablets administered twice daily
294434|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
294435|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
294436|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
294437|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
294438|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
294439|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
294440|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
294441|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
294442|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
294443|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
294444|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
294445|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
294446|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
294471|NCT01261052|B1|Baseline|All Study Participants|Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For one intervention for the first 13 hours, the original artificial pancreas algorithm FMPD, will be used to control the subject's blood glucose. After 13 hours, the adaptive component or APD will be used to control the subject's blood glucose for the remaining 20 hours. For the other intervention study, the adaptive component or APD will be used to control the subject's blood glucose for the entire 33 hours.
294472|NCT01261052|P1|Participant Flow|All Study Participants|Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For one intervention for the first 13 hours, the original artificial pancreas algorithm FMPD, will be used to control the subject's blood glucose. After 13 hours, the adaptive component or APD will be used to control the subject's blood glucose for the remaining 20 hours. For the other intervention study, the adaptive component or APD will be used to control the subject's blood glucose for the entire 33 hours.
294473|NCT01261052|O1|Outcome|All Study Participants|Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For one intervention for the first 13 hours, the original artificial pancreas algorithm FMPD, will be used to control the subject's blood glucose. After 13 hours, the adaptive component or APD will be used to control the subject's blood glucose for the remaining 20 hours. For the other intervention study, the adaptive component or APD will be used to control the subject's blood glucose for the entire 33 hours.
294474|NCT01261052|O1|Outcome|All Study Participants|Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For one intervention for the first 13 hours, the original artificial pancreas algorithm FMPD, will be used to control the subject's blood glucose. After 13 hours, the adaptive component or APD will be used to control the subject's blood glucose for the remaining 20 hours. For the other intervention study, the adaptive component or APD will be used to control the subject's blood glucose for the entire 33 hours.
294475|NCT01261052|E2|Reported Event|FMPD/APD Intervention|"The APD algorithm is based largely on a program that employs the Fading Memory Proportional Derivative (FMPD) insulin and glucagon infusion algorithm. The FMPD algorithm determines insulin and glucagon delivery rates based on proportional error, defined as the difference between the current glucose level and the target level, and the derivative error, defined as the rate of change of the glucose. The fading memory designation refers to weighting recent errors more heavily than remote errors.~The APD algorithm, like the FMPD algorithm, will determine insulin and glucagon infusion rates based on sensed glucose values and utilizes the derivative and proportional glucose error to determine delivery rates of insulin. However, the APD algorithm has a model predictive element which also leads to frequent measurement of tissue sensitivity to insulin."
294476|NCT01261052|E1|Reported Event|APD Only Intervention|"The APD algorithm is based largely on a program that employs the Fading Memory Proportional Derivative (FMPD) insulin and glucagon infusion algorithm. The FMPD algorithm determines insulin and glucagon delivery rates based on proportional error, defined as the difference between the current glucose level and the target level, and the derivative error, defined as the rate of change of the glucose. The fading memory designation refers to weighting recent errors more heavily than remote errors.~The APD algorithm, like the FMPD algorithm, will determine insulin and glucagon infusion rates based on sensed glucose values and utilizes the derivative and proportional glucose error to determine delivery rates of insulin. However, the APD algorithm has a model predictive element which also leads to frequent measurement of tissue sensitivity to insulin."
294477|NCT01261000|B1|Baseline|Pegvisomant|Pegvisomant: Pegvisomant used as indicated
294478|NCT01261000|P1|Participant Flow|Pegvisomant|Pegvisomant: Pegvisomant used as indicated
294479|NCT01261000|O1|Outcome|Pegvisomant|Pegvisomant: Pegvisomant used as indicated
294480|NCT01261000|E1|Reported Event|Pegvisomant|Pegvisomant: Pegvisomant used as indicated
294481|NCT01260948|B3|Baseline|Total|Total of all reporting groups
294482|NCT01260948|B2|Baseline|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
294483|NCT01260948|B1|Baseline|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
294484|NCT01260948|P2|Participant Flow|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
294485|NCT01260948|P1|Participant Flow|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
294486|NCT01260948|O2|Outcome|Aricept® (Reference)|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in either period.
294487|NCT01260948|O1|Outcome|Donepezil Hydrochloride (Test)|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in either period.
294488|NCT01260948|O2|Outcome|Aricept® (Reference)|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in either period.
294489|NCT01260948|O1|Outcome|Donepezil Hydrochloride (Test)|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in either period.
294490|NCT01260948|E2|Reported Event|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
294491|NCT01260948|E1|Reported Event|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
294492|NCT01260922|B3|Baseline|Total|Total of all reporting groups
294493|NCT01260922|B2|Baseline|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
294540|NCT01260883|O2|Outcome|R+ Ketorolac Volume Distribution Central|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
294495|NCT01260922|P2|Participant Flow|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
294496|NCT01260922|P1|Participant Flow|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
294497|NCT01260922|O2|Outcome|Aricept® (Reference)|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in either period.
294498|NCT01260922|O1|Outcome|Donepezil Hydrochloride (Test)|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in either period.
294499|NCT01260922|O2|Outcome|Aricept® (Reference)|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in either period.
294500|NCT01260922|O1|Outcome|Donepezil Hydrochloride (Test)|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in either period.
294501|NCT01260922|E2|Reported Event|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
294502|NCT01260922|E1|Reported Event|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
294503|NCT01260896|B3|Baseline|Total|Total of all reporting groups
294504|NCT01260896|B2|Baseline|Effexor® XR (Reference) First|150 mg Effexor® XR Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
294505|NCT01260896|B1|Baseline|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
294506|NCT01260896|P2|Participant Flow|Effexor® XR (Reference) First|150 mg Effexor® XR Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
294507|NCT01260896|P1|Participant Flow|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
294508|NCT01260896|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Capsules reference product dosed in either period.
294509|NCT01260896|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
294510|NCT01260896|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Capsules reference product dosed in either period.
294511|NCT01260896|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
294512|NCT01260896|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Capsules reference product dosed in either period.
294513|NCT01260896|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
294514|NCT01260896|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Capsules reference product dosed in either period.
294515|NCT01260896|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
294516|NCT01260896|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Capsules reference product dosed in either period.
294517|NCT01260896|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
294518|NCT01260896|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Capsules reference product dosed in either period.
294519|NCT01260896|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
294520|NCT01260896|E2|Reported Event|Effexor® XR (Reference) First|150 mg Effexor® XR Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
294521|NCT01260896|E1|Reported Event|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
294522|NCT01260883|B4|Baseline|Total|Total of all reporting groups
294523|NCT01260883|B3|Baseline|Dextrose 5% in Water (D5W)|intravenous infusion over 10 minutes
294524|NCT01260883|B2|Baseline|Ketorolac 0.5 mg/kg Intravenous|intravenous infusion over 10 minutes
294525|NCT01260883|B1|Baseline|Ketorolac 1 mg/kg Intravenous|intravenous infusion over 10 minutes
294526|NCT01260883|P3|Participant Flow|Dextrose 5% in Water (D5W)|intravenous infusion over 10 minutes
294527|NCT01260883|P2|Participant Flow|Ketorolac 0.5 mg/kg Intravenous|intravenous infusion over 10 minutes
294528|NCT01260883|P1|Participant Flow|Ketorolac 1 mg/kg Intravenous|intravenous infusion over 10 minutes
294529|NCT01260883|O2|Outcome|Placebo Infusion|infants receiving placebo infusion after surgery
294530|NCT01260883|O1|Outcome|Ketorolac 1 or 0.5 mg/kg|infants receiving ketorolac after surgery
294531|NCT01260883|O2|Outcome|Placebo Infusion|infants receiving placebo infusion after surgery
294532|NCT01260883|O1|Outcome|Ketorolac 1 or 0.5 mg/kg|infants receiving ketorolac infusion after surgery
294533|NCT01260883|O3|Outcome|Placebo|noncompartmental analysis of stereo-isomers of ketorolac
294534|NCT01260883|O2|Outcome|R+ Ketorolac Half-life|noncompartmental analysis of stereo-isomers of ketorolac
294535|NCT01260883|O1|Outcome|S- Ketorolac Half-life|noncompartmental ketorolac analysis
294536|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
294537|NCT01260883|O2|Outcome|R+ Ketorolac Volume Distribution, Peripheral|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
294538|NCT01260883|O1|Outcome|S- Ketorolac Volume Distribution, Peripheral|stereo-specific ketorolac analysis by NONMEM
294539|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
294548|NCT01260883|O1|Outcome|Ketorolac 1 or 0.5 mg/kg|infants receiving active drug intravenously after surgery
294549|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
294550|NCT01260883|O2|Outcome|R+ Ketorolac Half-life|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
294551|NCT01260883|O1|Outcome|S- Ketorolac Half-life|stereo-specific ketorolac analysis by NONMEM
294552|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
294553|NCT01260883|O2|Outcome|R+ Ketorolac Volume Distribution, Peripheral|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
294554|NCT01260883|O1|Outcome|S- Ketorolac Volume Distribution, Peripheral|stereo-specific ketorolac analysis by NONMEM
294555|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
294556|NCT01260883|O2|Outcome|R+ Ketorolac Volume Distribution, Central|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
294557|NCT01260883|O1|Outcome|S- Ketorolac Volume Distribution, Central|stereo-specific ketorolac analysis by NONMEM
294558|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac isomer concentrations from blood samples collected for 12 hours after ketorolac intravenous administration,analyzed by population pharmacokinetic analysis (NONMEM)
294559|NCT01260883|O2|Outcome|R+ Ketorolac Clearance|stereo-specific ketorolac isomer concentrations from blood samples collected for 12 hours after ketorolac intravenous administration,analyzed by population pharmacokinetic analysis (NONMEM)
294560|NCT01260883|O1|Outcome|S- Ketorolac Clearance|stereo-specific ketorolac isomer concentrations from blood samples collected for 12 hours after ketorolac intravenous administration, analyzed by NONMEM population pharmacokinetic methodology
294561|NCT01260883|E3|Reported Event|Dextrose 5% in Water (D5W)|intravenous infusion over 10 minutes
294562|NCT01260883|E2|Reported Event|Ketorolac 0.5 mg/kg Intravenous|intravenous infusion over 10 minutes
294563|NCT01260883|E1|Reported Event|Ketorolac 1 mg/kg Intravenous|intravenous infusion over 10 minutes
294564|NCT01260701|B1|Baseline|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294565|NCT01260701|P1|Participant Flow|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294566|NCT01260701|O1|Outcome|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294567|NCT01260701|O1|Outcome|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294568|NCT01260701|O1|Outcome|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294569|NCT01260701|O1|Outcome|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294570|NCT01260701|E1|Reported Event|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294571|NCT01260688|B3|Baseline|Total|Total of all reporting groups
294572|NCT01260688|B2|Baseline|Arm II - Cediranib Alone|Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294573|NCT01260688|B1|Baseline|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294574|NCT01260688|P2|Participant Flow|Arm II - Cediranib Alone|Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294575|NCT01260688|P1|Participant Flow|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294576|NCT01260688|O2|Outcome|Arm II - Cediranib Alone|Patients receive oral cediranib maleate once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294577|NCT01260688|O1|Outcome|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294578|NCT01260688|O2|Outcome|Arm II - Cediranib Alone|Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294579|NCT01260688|O1|Outcome|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294580|NCT01260688|O2|Outcome|Arm II - Cediranib Alone|Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294581|NCT01260688|O1|Outcome|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294582|NCT01260688|O2|Outcome|Arm II - Cediranib Alone|Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294583|NCT01260688|O1|Outcome|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294584|NCT01260688|O2|Outcome|Arm II - Cediranib Alone|Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294585|NCT01260688|O1|Outcome|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
295469|NCT01258985|P1|Participant Flow|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
294586|NCT01260688|O2|Outcome|Arm II - Cediranib Alone|Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294587|NCT01260688|O1|Outcome|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294588|NCT01260688|O2|Outcome|Arm II - Cediranib Alone|Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294589|NCT01260688|O1|Outcome|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294590|NCT01260688|O2|Outcome|Arm II - Cediranib Alone|Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294591|NCT01260688|O1|Outcome|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294592|NCT01260688|O2|Outcome|Arm II - Cediranib Alone|Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294593|NCT01260688|O1|Outcome|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294594|NCT01260688|O2|Outcome|Arm II - Cediranib Alone|Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294595|NCT01260688|O1|Outcome|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294596|NCT01260688|O2|Outcome|Arm II - Cediranib Alone|Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294597|NCT01260688|O1|Outcome|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294598|NCT01260688|O2|Outcome|Arm II - Cediranib Alone|Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294599|NCT01260688|O1|Outcome|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294600|NCT01260688|O2|Outcome|Arm II - Cediranib Alone|Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294601|NCT01260688|O1|Outcome|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294602|NCT01260688|O2|Outcome|Arm II - Cediranib Alone|Patients receive oral cediranib maleate (20mg) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
294603|NCT01260688|O1|Outcome|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate (20mg) once daily and oral dasatinib (100mg) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
294604|NCT01260688|O2|Outcome|Arm II - Cediranib Alone|Patients receive oral cediranib maleate once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294605|NCT01260688|O1|Outcome|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
294606|NCT01260688|E2|Reported Event|Arm II - Cediranib Alone|Patients receive oral cediranib maleate (20mg) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
294607|NCT01260688|E1|Reported Event|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate (20mg) once daily and oral dasatinib (100mg) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
294608|NCT01260662|B4|Baseline|Total|Total of all reporting groups
294609|NCT01260662|B3|Baseline|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
294610|NCT01260662|B2|Baseline|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
294611|NCT01260662|B1|Baseline|Propofol|"Deep sedation using propofol (10 mg /mL)~Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
294612|NCT01260662|P3|Participant Flow|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
294613|NCT01260662|P2|Participant Flow|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
294614|NCT01260662|P1|Participant Flow|Propofol|"Deep sedation using propofol (10 mg /mL)~Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
294615|NCT01260662|O3|Outcome|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
294616|NCT01260662|O2|Outcome|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
294617|NCT01260662|O1|Outcome|Propofol|"Deep sedation using propofol (10 mg /mL)~Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
294618|NCT01260662|O3|Outcome|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
294619|NCT01260662|O2|Outcome|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
294620|NCT01260662|O1|Outcome|Propofol|"Deep sedation using propofol (10 mg /mL)~Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
294621|NCT01260662|O3|Outcome|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
294622|NCT01260662|O2|Outcome|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
294623|NCT01260662|O1|Outcome|Propofol|"Deep sedation using propofol (10 mg /mL)~Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
294624|NCT01260662|O3|Outcome|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
294625|NCT01260662|O2|Outcome|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
294626|NCT01260662|O1|Outcome|Propofol|"Deep sedation using propofol (10 mg /mL)~Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
294627|NCT01260662|E3|Reported Event|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
294628|NCT01260662|E2|Reported Event|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
294629|NCT01260662|E1|Reported Event|Propofol|"Deep sedation using propofol (10 mg /mL)~Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
294630|NCT01260649|B3|Baseline|Total|Total of all reporting groups
294631|NCT01260649|B2|Baseline|Placebo|"IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.~Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
294632|NCT01260649|B1|Baseline|Ketamine|"ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
294633|NCT01260649|P2|Participant Flow|Placebo|"IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.~Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
294634|NCT01260649|P1|Participant Flow|Ketamine|"ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
294635|NCT01260649|O2|Outcome|Placebo|"IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.~Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
294636|NCT01260649|O1|Outcome|Ketamine|"ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
294637|NCT01260649|O2|Outcome|Placebo|"IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.~Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
294664|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
294638|NCT01260649|O1|Outcome|Ketamine|"ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
294639|NCT01260649|E2|Reported Event|Placebo|"IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.~Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
294640|NCT01260649|E1|Reported Event|Ketamine|"ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
294641|NCT01260584|B5|Baseline|Total|Total of all reporting groups
294642|NCT01260584|B4|Baseline|Prasugrel Then Clopidogrel Non-Smokers|"Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Clopidogrel : One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
294643|NCT01260584|B3|Baseline|Prasugrel Then Clopidogrel Smokers|"Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Clopidogrel : One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
294644|NCT01260584|B2|Baseline|Clopidogrel Then Prasugrel Non-Smokers|"Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Prasugrel : One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
294645|NCT01260584|B1|Baseline|Clopidogrel Then Prasugrel Smokers|"Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Prasugrel : One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
294646|NCT01260584|P4|Participant Flow|Prasugrel Then Clopidogrel Non-Smokers|"Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Clopidogrel : One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
294647|NCT01260584|P3|Participant Flow|Prasugrel Then Clopidogrel Smokers|"Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Clopidogrel : One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
294648|NCT01260584|P2|Participant Flow|Clopidogrel Then Prasugrel Non-Smokers|"Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Prasugrel : One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
294649|NCT01260584|P1|Participant Flow|Clopidogrel Then Prasugrel Smokers|"Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Prasugrel : One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
294650|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
294651|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
294652|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
294653|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
294654|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
294655|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
294656|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
294657|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
294658|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
294659|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
294660|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
294661|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
294662|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
294663|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
294665|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
294666|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
294667|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
294668|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
294669|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
294670|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
294671|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
294672|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
294673|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
294674|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
294675|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
294676|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
294677|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
294678|NCT01260584|E4|Reported Event|Clopidogrel Non-Smokers|"participants who do not currently smoke while receiving clopidogrel as test medication during study. 1 participant who started this arm was not at risk."
294679|NCT01260584|E3|Reported Event|Clopidogrel Smokers|"participants who currently smoke while receiving clopidogrel as test medication during study. 2 participants who started this arm were not At risk."
294680|NCT01260584|E2|Reported Event|Prasugrel Non-Smokers|"participants who do not currently smoke while receiving prasugrel as test medication during study. 1 participant who started the arm was not at risk."
294681|NCT01260584|E1|Reported Event|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
294682|NCT01260493|B3|Baseline|Total|Total of all reporting groups
294683|NCT01260493|B2|Baseline|Integrated Health Care Chain|"integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers~integrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers"
294684|NCT01260493|B1|Baseline|Conventional Care, Controlgroup|conventional care, control group
294685|NCT01260493|P2|Participant Flow|Integrated Health Care Chain|"integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers~integrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers"
294686|NCT01260493|P1|Participant Flow|Conventional Care, Controlgroup|conventional care, control group
294687|NCT01260493|O2|Outcome|Integrated Health Care Chain|"integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers~integrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers"
294688|NCT01260493|O1|Outcome|Conventional Care, Controlgroup|conventional care, control group
294689|NCT01260493|E2|Reported Event|Integrated Health Care Chain|"integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers~integrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers"
294690|NCT01260493|E1|Reported Event|Conventional Care, Controlgroup|conventional care, control group
294691|NCT01260467|B1|Baseline|Single Agent Memantine Group|memantine:10 milligrams orally twice a day
294692|NCT01260467|P1|Participant Flow|Single Agent Memantine Group|memantine:10 milligrams orally twice a day
294693|NCT01260467|O1|Outcome|Single Arm|No adverse events reported.
294694|NCT01260467|O1|Outcome|Memantine Arm|memantine: 10 milligrams orally twice a day
294695|NCT01260467|O1|Outcome|Single Agent Memantine Group|memantine:10 milligrams orally twice a day
294696|NCT01260467|E1|Reported Event|Single Agent Memantine Group|NO data to report
294697|NCT01260454|B1|Baseline|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.~Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
294698|NCT01260454|P1|Participant Flow|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.~Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
294699|NCT01260454|O1|Outcome|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.~Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
294700|NCT01260454|O1|Outcome|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.~Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
295512|NCT01258803|O3|Outcome|F DPI|Participants receiving a single dose of F DPI 20 mcg
294701|NCT01260454|O1|Outcome|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.~Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
294702|NCT01260454|E1|Reported Event|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.~Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
294703|NCT01260350|B21|Baseline|Total|Total of all reporting groups
294704|NCT01260350|B20|Baseline|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
294705|NCT01260350|B19|Baseline|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
294706|NCT01260350|B18|Baseline|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294707|NCT01260350|B17|Baseline|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
294708|NCT01260350|B16|Baseline|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
294709|NCT01260350|B15|Baseline|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294710|NCT01260350|B14|Baseline|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
294711|NCT01260350|B13|Baseline|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294712|NCT01260350|B12|Baseline|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
294713|NCT01260350|B11|Baseline|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294714|NCT01260350|B10|Baseline|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294715|NCT01260350|B9|Baseline|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
294716|NCT01260350|B8|Baseline|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294717|NCT01260350|B7|Baseline|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
294718|NCT01260350|B6|Baseline|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294719|NCT01260350|B5|Baseline|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294720|NCT01260350|B4|Baseline|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294721|NCT01260350|B3|Baseline|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294722|NCT01260350|B2|Baseline|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294723|NCT01260350|B1|Baseline|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
294724|NCT01260350|P22|Participant Flow|Group 22: LDV/SOF FDC 6 wk: GT 1, TN|Treatment-naive participants with genotype 1 HCV infection were randomized to receive LDV 90 mg/SOF 400 mg FDC once daily for 6 weeks.
294725|NCT01260350|P21|Participant Flow|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
294726|NCT01260350|P20|Participant Flow|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
294727|NCT01260350|P19|Participant Flow|Group 19: LDV/SOF FDC 12 wk: GT 2 or 3, TE|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
294728|NCT01260350|P18|Participant Flow|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
295343|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Buprenorphine-3-glucuronide was not measured in the plasma during treatment
294729|NCT01260350|P17|Participant Flow|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
294730|NCT01260350|P16|Participant Flow|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg fixed-dose combination (FDC) once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
294731|NCT01260350|P15|Participant Flow|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294732|NCT01260350|P14|Participant Flow|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
294733|NCT01260350|P13|Participant Flow|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294734|NCT01260350|P12|Participant Flow|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus ledipasvir (LDV) 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
294735|NCT01260350|P11|Participant Flow|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294736|NCT01260350|P10|Participant Flow|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294737|NCT01260350|P9|Participant Flow|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
294738|NCT01260350|P8|Participant Flow|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294739|NCT01260350|P7|Participant Flow|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
294740|NCT01260350|P6|Participant Flow|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294741|NCT01260350|P5|Participant Flow|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294742|NCT01260350|P4|Participant Flow|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294743|NCT01260350|P3|Participant Flow|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294744|NCT01260350|P2|Participant Flow|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294745|NCT01260350|P1|Participant Flow|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|Sofosbuvir (SOF) 400 mg once daily plus weight-based ribavirin (RBV) (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
294746|NCT01260350|O20|Outcome|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
294747|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
294748|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294749|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
294750|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
294751|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294752|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
294753|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294754|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
294755|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
295344|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|BTDS 10 with ketoconazole 200 mg tablets twice daily
294756|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294757|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
294758|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294759|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
294760|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294761|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294762|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294763|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294764|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294765|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
294766|NCT01260350|O13|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294767|NCT01260350|O12|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
294768|NCT01260350|O11|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294769|NCT01260350|O10|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
294770|NCT01260350|O9|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294771|NCT01260350|O8|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
294772|NCT01260350|O7|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294773|NCT01260350|O6|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
294774|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294775|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294776|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294777|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294778|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
294779|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
294780|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294781|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
294782|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
294783|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
295013|NCT01260142|O3|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
294784|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
294785|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294786|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
294787|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294788|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294789|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
294790|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294791|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
294792|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294793|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294794|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294795|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294796|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294797|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
294798|NCT01260350|O20|Outcome|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
294799|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
294800|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294801|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
294802|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
294803|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294804|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
294805|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294806|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
294807|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294808|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294809|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
294810|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294811|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
295513|NCT01258803|O2|Outcome|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
294812|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294813|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294814|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294815|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294816|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294817|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
294818|NCT01260350|O17|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
294819|NCT01260350|O16|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294820|NCT01260350|O15|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
294821|NCT01260350|O14|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
294822|NCT01260350|O13|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294823|NCT01260350|O12|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
294824|NCT01260350|O11|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294825|NCT01260350|O10|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
294826|NCT01260350|O9|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294827|NCT01260350|O8|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
294828|NCT01260350|O7|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294829|NCT01260350|O6|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
294830|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294831|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294832|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294833|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294834|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
294835|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
294836|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294837|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
294838|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
294839|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
295514|NCT01258803|O1|Outcome|MF/F MDI With Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
294840|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
294841|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294842|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
294843|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294844|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294845|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
294846|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294847|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
294848|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294849|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294850|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294851|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294852|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294853|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
294854|NCT01260350|O20|Outcome|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
294855|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
294856|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294857|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
294858|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
294859|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294860|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
294861|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294862|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
294863|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294864|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294865|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
294866|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294867|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
295515|NCT01258803|O2|Outcome|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
294868|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294869|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294870|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294871|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294872|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294873|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
294874|NCT01260350|O20|Outcome|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
294875|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
294876|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294877|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
294878|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
294879|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294880|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
294881|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294882|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
294883|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294884|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294885|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
294886|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294887|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
294888|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294889|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294890|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294891|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294892|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294893|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
294894|NCT01260350|O20|Outcome|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
294895|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
294896|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294897|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
294898|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
294899|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294900|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
294901|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294902|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
294903|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294904|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294905|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
294906|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294907|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
294908|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294909|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294910|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294911|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294912|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294913|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
294914|NCT01260350|E20|Reported Event|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
294915|NCT01260350|E19|Reported Event|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
294916|NCT01260350|E18|Reported Event|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294917|NCT01260350|E17|Reported Event|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
294918|NCT01260350|E16|Reported Event|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
294919|NCT01260350|E15|Reported Event|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294920|NCT01260350|E14|Reported Event|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
294921|NCT01260350|E13|Reported Event|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294922|NCT01260350|E12|Reported Event|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
294923|NCT01260350|E11|Reported Event|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294924|NCT01260350|E10|Reported Event|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294925|NCT01260350|E9|Reported Event|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
294926|NCT01260350|E8|Reported Event|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
294927|NCT01260350|E7|Reported Event|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
294928|NCT01260350|E6|Reported Event|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294929|NCT01260350|E5|Reported Event|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294930|NCT01260350|E4|Reported Event|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294931|NCT01260350|E3|Reported Event|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294932|NCT01260350|E2|Reported Event|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
294933|NCT01260350|E1|Reported Event|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
294934|NCT01260324|B3|Baseline|Total|Total of all reporting groups
294935|NCT01260324|B2|Baseline|Controls|From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)
294936|NCT01260324|B1|Baseline|NAION Cases|Nonarteritic anterior ischemic optic neuropathy (NAION). From the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.
294937|NCT01260324|P2|Participant Flow|Controls|From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)
294938|NCT01260324|P1|Participant Flow|NAION Cases|Nonarteritic anterior ischemic optic neuropathy (NAION). From the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.
294939|NCT01260324|O1|Outcome|NAION Cases|NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review. Data from definite and possible NAION cases identified from medical record review only contributed to the analysis.
294940|NCT01260324|O1|Outcome|NAION Cases|NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review. Data from definite and possible NAION cases identified from medical record review only contributed to the analysis.
294941|NCT01260324|O1|Outcome|NAION Cases|NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review. Data from definite and possible NAION cases identified from medical record review only contributed to the analysis.
294942|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.~Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
294943|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.~Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
294944|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.~Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
294985|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
295516|NCT01258803|O1|Outcome|MF/F MDI With Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
294945|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.~Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
294946|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.~Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
294947|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.~Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
294948|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.~Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
294949|NCT01260324|E2|Reported Event|Controls|From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)
294950|NCT01260324|E1|Reported Event|NAION Cases|Nonarteritic anterior ischemic optic neuropathy (NAION). From the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.
294951|NCT01260311|B1|Baseline|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
294952|NCT01260311|P1|Participant Flow|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 milligram (mg) or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
294953|NCT01260311|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
294954|NCT01260311|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
294955|NCT01260311|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
294956|NCT01260311|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
294957|NCT01260311|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
294958|NCT01260311|E1|Reported Event|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
294959|NCT01260272|B3|Baseline|Total|Total of all reporting groups
294960|NCT01260272|B2|Baseline|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
294961|NCT01260272|B1|Baseline|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
294962|NCT01260272|P2|Participant Flow|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
294986|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
294987|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
294963|NCT01260272|P1|Participant Flow|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
294964|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins: Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
294965|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator: Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
294966|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
294967|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
294968|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
294969|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
294970|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins: Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
294971|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator: Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
294972|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins: Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
294988|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
294989|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
295520|NCT01258803|O1|Outcome|MF/F MDI With Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
294973|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator: Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
294974|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
294975|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
294976|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
294977|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
294978|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
294979|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
294980|NCT01260272|E2|Reported Event|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
294981|NCT01260272|E1|Reported Event|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
294982|NCT01260194|B1|Baseline|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
294983|NCT01260194|P1|Participant Flow|Trastuzumab|Trastuzumab was administered at a loading dose of 8 milligram per kilogram (mg/kg) body weight on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
294984|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
294990|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
294991|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
294992|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
294993|NCT01260194|E1|Reported Event|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
294994|NCT01260142|B7|Baseline|Total|Total of all reporting groups
294995|NCT01260142|B6|Baseline|Cohort 3 ( Sequence F)|Participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 15 mg/kg of fospropofol disodium.
294996|NCT01260142|B5|Baseline|Cohort 3 (Sequence E)|Participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.5 mg/kg propofol injectable emulsion.
294997|NCT01260142|B4|Baseline|Cohort 2 (Sequence D)|Participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 10 mg/kg of fospropofol disodium.
294998|NCT01260142|B3|Baseline|Cohort 2 (Sequence C)|Participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.0 mg/kg propofol injectable emulsion.
294999|NCT01260142|B2|Baseline|Cohort 1 (Sequence B)|Participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 6.5 mg/kg of fospropofol disodium.
295000|NCT01260142|B1|Baseline|Cohort 1 (Sequence A)|Participants were administered an intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 0.65 mg/kg propofol injectable emulsion.
295001|NCT01260142|P6|Participant Flow|Cohort 3 (Sequence F)|Participants were administered an intravenous IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 15 mg/kg of fospropofol disodium.
295002|NCT01260142|P5|Participant Flow|Cohort 3 (Sequence E)|Participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.5 mg/kg propofol injectable emulsion.
295003|NCT01260142|P4|Participant Flow|Cohort 2 (Sequence D)|Participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 10 mg/kg of fospropofol disodium.
295004|NCT01260142|P3|Participant Flow|Cohort 2 (Sequence C)|Participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.0 mg/kg propofol injectable emulsion.
295005|NCT01260142|P2|Participant Flow|Cohort 1 (Sequence B)|Participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 6.5 mg/kg of fospropofol disodium.
295006|NCT01260142|P1|Participant Flow|Cohort 1 (Sequence A)|Participants were administered intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 0.65 mg/kg propofol injectable emulsion.
295007|NCT01260142|O3|Outcome|Cohort 3 (Fospropofol 15.0 : Propofol 1.5)|"Cohort 3 (Sequence E): participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.5 mg/kg propofol injectable emulsion.~Cohort (Sequence F): participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 15 mg/kg of fospropofol disodium."
295008|NCT01260142|O2|Outcome|Cohort 2 (Fospropofol 10.0 : Propofol 1.0)|"Cohort 2 (Sequence C): Participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.0 mg/kg propofol injectable emulsion.~Cohort 2 (Sequence D): Participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 10 mg/kg of fospropofol disodium."
295009|NCT01260142|O1|Outcome|Cohort 1 (Fospropofol 6.5 : Propofol 0.65)|"Cohort 1 (Sequence A): participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 0.65 mg/kg propofol injectable emulsion.~Cohort 1: Sequence B: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 6.5 mg/kg of fospropofol disodium."
295010|NCT01260142|O6|Outcome|Propofol 1.5 mg/kg|Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
295011|NCT01260142|O5|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
295012|NCT01260142|O4|Outcome|Propofol 1.0 mg/kg|Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
295014|NCT01260142|O2|Outcome|Propofol 0.65 mg/kg|Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
295015|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
295016|NCT01260142|O6|Outcome|Propofol 1.5 mg/kg|Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
295017|NCT01260142|O5|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
295018|NCT01260142|O4|Outcome|Propofol 1.0 mg/kg|Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
295019|NCT01260142|O3|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
295020|NCT01260142|O2|Outcome|Propofol 0.65 mg/kg|Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
295021|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
295022|NCT01260142|O6|Outcome|Propofol 1.5 mg/kg|Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
295023|NCT01260142|O5|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
295024|NCT01260142|O4|Outcome|Propofol 1.0 mg/kg|Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
295025|NCT01260142|O3|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
295026|NCT01260142|O2|Outcome|Propofol 0.65 mg/kg|Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
295027|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
295028|NCT01260142|O3|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
295029|NCT01260142|O2|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
295030|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
295031|NCT01260142|O6|Outcome|Propofol 1.5 mg/kg|Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
295032|NCT01260142|O5|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
295033|NCT01260142|O4|Outcome|Propofol 1.0 mg/kg|Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
295034|NCT01260142|O3|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
295035|NCT01260142|O2|Outcome|Propofol 0.65 mg/kg|Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
295036|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
295037|NCT01260142|O3|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
295038|NCT01260142|O2|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
295039|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
295040|NCT01260142|O6|Outcome|Propofol 1.5 mg/kg|Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
295041|NCT01260142|O5|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
295042|NCT01260142|O4|Outcome|Propofol 1.0 mg/kg|Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
295043|NCT01260142|O3|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
295044|NCT01260142|O2|Outcome|Propofol 0.65 mg/kg|Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
295045|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
295046|NCT01260142|O3|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
295047|NCT01260142|O2|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
295048|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
295049|NCT01260142|E6|Reported Event|Propofol 1.5 mg/kg|Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
295050|NCT01260142|E5|Reported Event|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
295051|NCT01260142|E4|Reported Event|Propofol 1.0 mg/kg|Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
295052|NCT01260142|E3|Reported Event|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
295053|NCT01260142|E2|Reported Event|Propofol 0.65 mg/kg|Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
295054|NCT01260142|E1|Reported Event|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
295055|NCT01259726|B5|Baseline|Total|Total of all reporting groups
295056|NCT01259726|B4|Baseline|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
295057|NCT01259726|B3|Baseline|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
295058|NCT01259726|B2|Baseline|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
295059|NCT01259726|B1|Baseline|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
295060|NCT01259726|P4|Participant Flow|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
295061|NCT01259726|P3|Participant Flow|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
295062|NCT01259726|P2|Participant Flow|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
295063|NCT01259726|P1|Participant Flow|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
295064|NCT01259726|O4|Outcome|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
295065|NCT01259726|O3|Outcome|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
295066|NCT01259726|O2|Outcome|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
295067|NCT01259726|O1|Outcome|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
295068|NCT01259726|O4|Outcome|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
295069|NCT01259726|O3|Outcome|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
295070|NCT01259726|O2|Outcome|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
295071|NCT01259726|O1|Outcome|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
295072|NCT01259726|O4|Outcome|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
295073|NCT01259726|O3|Outcome|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
295074|NCT01259726|O2|Outcome|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
295075|NCT01259726|O1|Outcome|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
295076|NCT01259726|O4|Outcome|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
295077|NCT01259726|O3|Outcome|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
295111|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
295078|NCT01259726|O2|Outcome|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
295079|NCT01259726|O1|Outcome|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
295080|NCT01259726|O4|Outcome|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
295081|NCT01259726|O3|Outcome|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
295082|NCT01259726|O2|Outcome|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
295083|NCT01259726|O1|Outcome|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
295084|NCT01259726|O4|Outcome|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
295085|NCT01259726|O3|Outcome|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
295086|NCT01259726|O2|Outcome|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
295087|NCT01259726|O1|Outcome|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
295088|NCT01259726|E4|Reported Event|VP20621 High Dose|VP20621: VP20621 as oral liquid once daily for 14 days
295089|NCT01259726|E3|Reported Event|VP20621 High Dose and Placebo|VP20621: VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days Placebo: 10 mL placebo once daily for 14 days
295090|NCT01259726|E2|Reported Event|VP20621 Low Dose and Placebo|VP20621: VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days Placebo: 10 mL placebo once daily for 14 days
295091|NCT01259726|E1|Reported Event|Placebo|Placebo: 10 mL placebo once daily for 14 days
295092|NCT01259713|B3|Baseline|Total|Total of all reporting groups
295093|NCT01259713|B2|Baseline|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
295094|NCT01259713|B1|Baseline|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
295095|NCT01259713|P2|Participant Flow|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
295096|NCT01259713|P1|Participant Flow|Liposomal Amphotericin B|Liposomal amphotericin B (AmBisome®) 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
295097|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
295098|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
295099|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
295100|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
295101|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
295102|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
295103|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
295104|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
295105|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
295106|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
295107|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
295108|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
295109|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
295110|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
295112|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
295113|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
295114|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
295115|NCT01259713|E2|Reported Event|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
295116|NCT01259713|E1|Reported Event|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
295117|NCT01259596|B3|Baseline|Total|Total of all reporting groups
295118|NCT01259596|B2|Baseline|Nondirective Supportive Therapy|"Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings~psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
295119|NCT01259596|B1|Baseline|Cognitive-behavioral Therapy|"Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention~psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
295120|NCT01259596|P2|Participant Flow|Nondirective Supportive Therapy|"Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings~psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
295121|NCT01259596|P1|Participant Flow|Cognitive-behavioral Therapy|"Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention~psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
295122|NCT01259596|O2|Outcome|Nondirective Supportive Therapy|"Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings~psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
295123|NCT01259596|O1|Outcome|Cognitive-behavioral Therapy|"Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention~psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
295124|NCT01259596|O2|Outcome|Nondirective Supportive Therapy|"Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings~psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
295125|NCT01259596|O1|Outcome|Cognitive-behavioral Therapy|"Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention~psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
295126|NCT01259596|O2|Outcome|Nondirective Supportive Therapy|"Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings~psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
295127|NCT01259596|O1|Outcome|Cognitive-behavioral Therapy|"Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention~psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
295128|NCT01259596|O2|Outcome|Nondirective Supportive Therapy|"Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings~nondirective supportive therapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
295129|NCT01259596|O1|Outcome|Cognitive Behavioral Therapy|"Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention~cognitive behavioral therapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
295130|NCT01259596|O2|Outcome|Nondirective Supportive Therapy|"Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings~psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
295131|NCT01259596|O1|Outcome|Cognitive-behavioral Therapy|"Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention~psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
295132|NCT01259596|O2|Outcome|Nondirective Supportive Therapy|"Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings~psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
295133|NCT01259596|O1|Outcome|Cognitive-behavioral Therapy|"Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention~psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
295134|NCT01259596|O2|Outcome|Nondirective Supportive Therapy|"Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings~psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
295345|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
295135|NCT01259596|O1|Outcome|Cognitive-behavioral Therapy|"Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention~psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
295136|NCT01259596|E2|Reported Event|Nondirective Supportive Therapy|"Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings~psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
295137|NCT01259596|E1|Reported Event|Cognitive-behavioral Therapy|"Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention~psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions"
295138|NCT01259492|B5|Baseline|Total|Total of all reporting groups
295139|NCT01259492|B4|Baseline|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295140|NCT01259492|B3|Baseline|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295141|NCT01259492|B2|Baseline|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295142|NCT01259492|B1|Baseline|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295143|NCT01259492|P4|Participant Flow|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295144|NCT01259492|P3|Participant Flow|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295145|NCT01259492|P2|Participant Flow|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295146|NCT01259492|P1|Participant Flow|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295147|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295517|NCT01258803|O2|Outcome|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
295148|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295149|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295150|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295151|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295152|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295153|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295154|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295155|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295156|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295157|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295336|NCT01259115|P1|Participant Flow|Sequence A: BTDS 10 With Ketoconazole (Test) First|"Period 1: Buprenorphine transdermal system (BTDS) 10 with ketoconazole 200 mg tablets twice daily (Test) first;~Washout Period of 4 to 18 days;~Period 2: BTDS 10 with ketoconazole placebo tablets twice daily."
295158|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295159|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295160|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295161|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295162|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295163|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295164|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295165|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295166|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295167|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295190|NCT01259492|E2|Reported Event|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295168|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295169|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295170|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295171|NCT01259492|O1|Outcome|ALL Ritalin LA Group|This group combined all Ritalin patients on 40 mg, 60 mg and 80 mg. n=492
295172|NCT01259492|O1|Outcome|ALL Ritalin LA Group|This group combined all Ritalin patients on 40 mg, 60 mg and 80 mg. n=492
295173|NCT01259492|O1|Outcome|ALL Ritalin LA Group|This group combined all Ritalin patients on 40 mg, 60 mg and 80 mg. n=492
295174|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295175|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295176|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295177|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295178|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295179|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295218|NCT01259427|O1|Outcome|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
295180|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295181|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295182|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295183|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295184|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295185|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295186|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295187|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295188|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295189|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
295337|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Buprenorphine transdermal system (BTDS) 10 with ketoconazole placebo oral tablets twice daily.
295338|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Buprenorphine transdermal system (BTDS) 10 with ketoconazole 200 mg tablets twice daily.
295191|NCT01259492|E1|Reported Event|All Ritalin LA|"All Ritalin LA:~In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients continued on their optimal dose."
295192|NCT01259466|B3|Baseline|Total|Total of all reporting groups
295193|NCT01259466|B2|Baseline|Health Education + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
295194|NCT01259466|B1|Baseline|Cognitive Behavioral Treatment + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
295195|NCT01259466|P2|Participant Flow|Health Education + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
295196|NCT01259466|P1|Participant Flow|Cognitive Behavioral Treatment + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
295197|NCT01259466|O2|Outcome|Health Education + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
295198|NCT01259466|O1|Outcome|Cognitive Behavioral Treatment + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
295199|NCT01259466|O2|Outcome|Health Education + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
295200|NCT01259466|O1|Outcome|Cognitive Behavioral Treatment + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
295201|NCT01259466|E2|Reported Event|Health Education + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
295202|NCT01259466|E1|Reported Event|Cognitive Behavioral Treatment + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
295203|NCT01259440|B3|Baseline|Total|Total of all reporting groups
295204|NCT01259440|B2|Baseline|Usual Care|Usual Care: Consists of one week telephone call and one month clinic visit
295205|NCT01259440|B1|Baseline|Video Teleconferencing Care|Video Teleconferencing Care: The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication.
295206|NCT01259440|P2|Participant Flow|Usual Care|Usual Care: Consists of one week telephone call and one month clinic visit
295207|NCT01259440|P1|Participant Flow|Video Teleconferencing Care|Video Teleconferencing Care: The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication.
295208|NCT01259440|O2|Outcome|Usual Care|Usual Care: Consists of one week telephone call and one month clinic visit
295209|NCT01259440|O1|Outcome|Video Teleconferencing Care|Video Teleconferencing Care: The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication.
295210|NCT01259440|E2|Reported Event|Usual Care|Usual Care: Consists of one week telephone call and one month clinic visit
295211|NCT01259440|E1|Reported Event|Video Teleconferencing Care|Video Teleconferencing Care: The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication.
295212|NCT01259427|B3|Baseline|Total|Total of all reporting groups
295213|NCT01259427|B2|Baseline|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc).
295214|NCT01259427|B1|Baseline|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
295215|NCT01259427|P2|Participant Flow|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc.).
295216|NCT01259427|P1|Participant Flow|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
295217|NCT01259427|O2|Outcome|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc.).
295219|NCT01259427|O2|Outcome|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc.).
295220|NCT01259427|O1|Outcome|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
295221|NCT01259427|O2|Outcome|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc.).
295222|NCT01259427|O1|Outcome|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
295223|NCT01259427|O2|Outcome|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc.).
295224|NCT01259427|O1|Outcome|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
295225|NCT01259427|O2|Outcome|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc).
295226|NCT01259427|O1|Outcome|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
295227|NCT01259427|O2|Outcome|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc).
295228|NCT01259427|O1|Outcome|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
295229|NCT01259427|E2|Reported Event|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc).
295230|NCT01259427|E1|Reported Event|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
295231|NCT01259401|B3|Baseline|Total|Total of all reporting groups
295232|NCT01259401|B2|Baseline|Control Group|"The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care~Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education."
295233|NCT01259401|B1|Baseline|SIP Group|"The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.~Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia."
295234|NCT01259401|P2|Participant Flow|Control Group|"The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care~Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education."
295334|NCT01259115|B1|Baseline|Overall Study|Subjects received BTDS 10 with ketoconazole 200 mg or ketoconazole placebo tablets twice daily in period 1; Washout Period for 4 to 18 days; Subjects received BTDS 10 with ketoconazole 200 mg or ketoconazole placebo tablets twice daily in period 2.
295235|NCT01259401|P1|Participant Flow|SIP Group|"The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.~Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia."
295236|NCT01259401|O2|Outcome|Control Group|"The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care~Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education."
295237|NCT01259401|O1|Outcome|SIP Group|"The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.~Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia."
295238|NCT01259401|O2|Outcome|Control Group|"The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care~Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education."
295239|NCT01259401|O1|Outcome|SIP Group|"The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.~Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia."
295240|NCT01259401|E2|Reported Event|Control Group|"The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care~Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education."
295241|NCT01259401|E1|Reported Event|SIP Group|"The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.~Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia."
295242|NCT01259375|B1|Baseline|All Groups|All patients that received treatment.
295243|NCT01259375|P1|Participant Flow|All Patients|"All participants enrolled.~Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously"
295244|NCT01259375|O1|Outcome|All Groups|All patients who had a partial or greater response
295245|NCT01259375|O1|Outcome|All Patients|"All participants who received Amrubicin.~Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously"
295246|NCT01259375|O1|Outcome|All Patients|"All participants enrolled.~Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously"
295247|NCT01259375|O1|Outcome|All Patients|"All participants enrolled.~Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously"
295248|NCT01259375|O1|Outcome|All Patients|"All participants who received Amrubicin.~Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously"
295249|NCT01259375|O1|Outcome|All Patients|"All participants enrolled.~Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously"
295250|NCT01259375|E1|Reported Event|All Patients|"All participants enrolled.~Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously"
295251|NCT01259297|B9|Baseline|Total|Total of all reporting groups
295252|NCT01259297|B8|Baseline|Placebo for Aliskiren + Placebo for Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for Amlodipine 5 mg once daily"
295253|NCT01259297|B7|Baseline|Amlodipine + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were run-in stratum randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received Amlodipine 5 mg + placebo for Aliskiren 300 mg once daily"
295254|NCT01259297|B6|Baseline|Placebo for Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
295255|NCT01259297|B5|Baseline|HCTZ + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received HCTZ 25 mg + placebo for Aliskiren 300 mg once daily"
295256|NCT01259297|B4|Baseline|Aliskiren + Placebo for Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for Amlodipine 5 mg"
295257|NCT01259297|B3|Baseline|Aliskiren + Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~Patients randomized to this arm received Aliskiren 300 mg + Amlodipine 5 mg once daily during the double blind period."
295258|NCT01259297|B2|Baseline|Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
295259|NCT01259297|B1|Baseline|Aliskiren + Hydrochlorothiazide (HCTZ)|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~Patients randomized to this arm received Aliskiren 300 mg + HCTZ 25 mg once daily."
295339|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Buprenorphine-3-glucuronide was not measured in the plasma during treatment
295340|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|BTDS 10 with ketoconazole 200 mg tablets twice daily
295260|NCT01259297|P8|Participant Flow|Placebo for Aliskiren + Placebo for Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for Amlodipine 5 mg once daily"
295261|NCT01259297|P7|Participant Flow|Amlodipine + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received Amlodipine 5 mg + placebo for Aliskiren 300 mg once daily"
295262|NCT01259297|P6|Participant Flow|Placebo for Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
295263|NCT01259297|P5|Participant Flow|HCTZ + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received HCTZ 25 mg + placebo for Aliskiren 300 mg once daily"
295264|NCT01259297|P4|Participant Flow|Aliskiren + Placebo for Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for Amlodipine 5 mg"
295265|NCT01259297|P3|Participant Flow|Aliskiren + Amlodipine|"In run-in period (4-5 weeks) , patients on thiazide background therapy and approximately 50% of patients on neither CCB nor thiazide background therapy received Amlodipine 5 mg and Aliskiren 150/300 mg daily in a titrated manner as per protocol.~In double blind period, patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~Patients randomized to this arm received Aliskiren 300 mg + Amlodipine 5 mg once daily during the double blind period."
295266|NCT01259297|P2|Participant Flow|Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
295267|NCT01259297|P1|Participant Flow|Aliskiren + Hydrochlorothiazide (HCTZ)|"In run-in period (4-5 weeks) , patients on CCB background therapy and approximately 50% of patients on neither thiazide nor CCB background therapy: received hydrochlorothiazide 12.5/25 mg and Aliskiren 150/300 mg daily in a titrated manner as per protocol.~In double blind period, all patients who successfully completed run-in with HCTZ plus aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~Patients randomized to this arm received Aliskiren 300 mg + HCTZ 25 mg once daily."
295268|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
295269|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + Hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
295270|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
295271|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + Hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
295272|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
295273|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + Hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
295274|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
295275|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
295276|NCT01259297|O2|Outcome|Placebo|This reporting group includes all the patients who has received placebo of aliskiren plus placebo of an additional BP lowering drug (amlodipine or hydrochlorothiazide). This reporting group includes patients from arms such as Placebo for Aliskiren + Placebo for HCTZ and Placebo for aliskiren + Placebo for Amlodipine .
295277|NCT01259297|O1|Outcome|Aliskiren+Amlodipine/HCTZ Group|This reporting group includes all the patients who has received Aliskiren plus an additional BP lowering drug (Amlodipine or Hydrochlorothiazide). This reporting group includes patients from arms such as Aliskiren + Hydrochlorothiazide (HCTZ) and Aliskiren + Amlodipine.
295278|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
295279|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + Hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
295341|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Buprenorphine-3-glucuronide was not measured in the plasma during treatment
295728|NCT01258504|E2|Reported Event|Bosentan at Steady-state|bosentan 62.5 mg p.o. b.i.d. day 2-10
295280|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
295281|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + Hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
295282|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
295283|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
295284|NCT01259297|E10|Reported Event|Double Blind Period: Placebo for Aliskiren + Placebo for Amlod|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for Amlodipine 5 mg once daily"
295285|NCT01259297|E9|Reported Event|Double Blind Period: Amlodipine + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received Amlodipine 5 mg + placebo for Aliskiren 300 mg once daily"
295286|NCT01259297|E8|Reported Event|Double Blind Period: Placebo for Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
295287|NCT01259297|E7|Reported Event|Double Blind Period: HCTZ + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received HCTZ 25 mg + placebo for Aliskiren 300 mg once daily"
295288|NCT01259297|E6|Reported Event|Double Blind Period: Aliskiren + Placebo for Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for Amlodipine 5 mg"
295289|NCT01259297|E5|Reported Event|Double Blind Period: Aliskiren + Amlodipine|"In double blind period, patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~Patients randomized to this arm received Aliskiren 300 mg + Amlodipine 5 mg once daily during the double blind period."
295290|NCT01259297|E4|Reported Event|Double Blind Period: Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
295291|NCT01259297|E3|Reported Event|Double Blind Period: Aliskiren + Hydrochlorothiazide (HCTZ)|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~Patients randomized to this arm received Aliskiren 300 mg + HCTZ 25 mg once daily."
295292|NCT01259297|E2|Reported Event|Run-in Period: Aliskiren + Amlodipine|"In run-in period (4-5 weeks) , patients on thiazide background therapy and approximately 50% of patients on neither CCB nor thiazide background therapy received Amlodipine 5 mg and Aliskiren 150/300 mg daily in a titrated manner as per protocol.~Patients randomized to this arm received Aliskiren 300 mg + Amlodipine 5 mg once daily during the double blind period."
295293|NCT01259297|E1|Reported Event|Run-in Period: Aliskiren + Hydrochlorothiazide (HCTZ)|"In run-in period (4-5 weeks) , patients on CCB background therapy and approximately 50% of patients on neither thiazide nor CCB background therapy: received Hydrochlorothiazide 12.5/25 mg and Aliskiren 150/300 mg daily in a titrated manner as per protocol.~Patients randomized to this arm received Aliskiren 300 mg + HCTZ 25 mg once daily."
295294|NCT01259284|B4|Baseline|Total|Total of all reporting groups
295295|NCT01259284|B3|Baseline|Placebo|4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
295296|NCT01259284|B2|Baseline|Fish Oil Supplement|3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.
295297|NCT01259284|B1|Baseline|Atorvastatin|1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.
295298|NCT01259284|P3|Participant Flow|Placebo|4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
295299|NCT01259284|P2|Participant Flow|Fish Oil Supplement|3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.
295300|NCT01259284|P1|Participant Flow|Atorvastatin|1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.
295301|NCT01259284|O3|Outcome|Placebo|4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
295302|NCT01259284|O2|Outcome|Fish Oil Supplement|3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.
295303|NCT01259284|O1|Outcome|Atorvastatin|1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.
295304|NCT01259284|E3|Reported Event|Placebo|4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
295305|NCT01259284|E2|Reported Event|Fish Oil Supplement|3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.
295306|NCT01259284|E1|Reported Event|Atorvastatin|1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.
295307|NCT01259245|B3|Baseline|Total|Total of all reporting groups
295335|NCT01259115|P2|Participant Flow|Sequence B: BTDS 10 With Placebo (Reference) First|"Period 1: Buprenorphine transdermal system (BTDS) 10 with ketoconazole placebo tablets twice daily (Reference) first~Washout Period of 4 to 18 days;~Period 2: BTDS 10 with ketoconazole 200 mg tablets twice daily."
295729|NCT01258504|E1|Reported Event|Bosentan After First Dose|bosentan 125 mg p.o. day 1 single dose
295308|NCT01259245|B2|Baseline|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
295309|NCT01259245|B1|Baseline|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
295310|NCT01259245|P2|Participant Flow|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
295311|NCT01259245|P1|Participant Flow|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
295312|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
295313|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
295314|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
295315|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
295316|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
295317|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
295318|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
295342|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|BTDS 10 with ketoconazole 200 mg tablets twice daily
295518|NCT01258803|O1|Outcome|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
295319|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
295320|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
295321|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
295322|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
295323|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
295324|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
295325|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
295326|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
295327|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
295328|NCT01259245|O2|Outcome|PRP+Tai Chi|
295329|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|
295330|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
295331|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
295332|NCT01259245|E2|Reported Event|Pulmonary Rehabilitation Program PRP|Subjects who received formal pulmonary rehabilitation program
295333|NCT01259245|E1|Reported Event|PRP + Tai Chi|Tai Chi elements added to PRP program
295346|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
295347|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
295348|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
295349|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
295350|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
295351|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
295352|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
295353|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
295354|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
295355|NCT01259115|O1|Outcome|All Subjects|Subjects who received BTDS with Ketoconazole treatment
295356|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
295357|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
295358|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
295359|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
295360|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
295361|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
295362|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
295363|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
295364|NCT01259115|E2|Reported Event|BTDS With Placebo|Subjects who were treated with buprenorphine transdermal patch 10 mcg/hour with ketoconazole placebo oral tablets twice daily.
295365|NCT01259115|E1|Reported Event|BTDS With Ketoconazole|Subjects who were treated with buprenorphine transdermal patch 10 mcg/hour with ketoconazole 200 mg oral tablets twice daily.
295366|NCT01259102|B6|Baseline|Total|Total of all reporting groups
295367|NCT01259102|B5|Baseline|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
295368|NCT01259102|B4|Baseline|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
295369|NCT01259102|B3|Baseline|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
295370|NCT01259102|B2|Baseline|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
295371|NCT01259102|B1|Baseline|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
295372|NCT01259102|P5|Participant Flow|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
295373|NCT01259102|P4|Participant Flow|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
295374|NCT01259102|P3|Participant Flow|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
295730|NCT01258387|B9|Baseline|Total|Total of all reporting groups
295375|NCT01259102|P2|Participant Flow|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
295376|NCT01259102|P1|Participant Flow|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
295377|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
295378|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
295379|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
295380|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
295381|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
295382|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
295383|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
295384|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
295385|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
295386|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
295387|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
295388|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
295389|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
295390|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
295391|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
295392|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
295393|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
295394|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
295395|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
295396|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
295397|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
295398|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
295399|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
295400|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
295401|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
295402|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
295403|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
295404|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
295405|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
295406|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
295407|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
295408|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
295409|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
295410|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
295411|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
295412|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
295413|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
295414|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
295415|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
295416|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
295417|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
295418|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
295419|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
295420|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
295421|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
295422|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
295423|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
295424|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
295425|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
295426|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
295427|NCT01259102|E5|Reported Event|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
295428|NCT01259102|E4|Reported Event|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
295429|NCT01259102|E3|Reported Event|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
295430|NCT01259102|E2|Reported Event|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
295431|NCT01259102|E1|Reported Event|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
295432|NCT01259063|B1|Baseline|Pts Who Failed or Relapsed After Intravesical BCG|Phase I: Everolimus will be administered as follows: Dose level 1: 5 mg every other day, Dose level 2: 5 mg daily, Dose level 3: 10 mg daily Phase II: Everolimus will be administered at the dose determined in Phase .Everolimus will be continued for 12 months in the patients who achieve a CR or a Partial Response. Patients demonstrating a CR (by cystoscopy and cytology) or a Partial Response at their Cycle 12 cystoscopy will be observed with serial cystoscopies every 3 months.
295433|NCT01259063|P1|Participant Flow|Everolimus and Intravesical Gemcitabine|Phase I: Everolimus will be administered as follows: Dose level 1: 5 mg every other day, Dose level 2: 5 mg daily, Dose level 3: 10 mg daily Phase II: Everolimus will be administered at the dose determined in Phase .Everolimus will be continued for 12 months in the patients who achieve a CR or a Partial Response.
295519|NCT01258803|O2|Outcome|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
295434|NCT01259063|O1|Outcome|Pts Who Failed or Relapsed After Intravesical BCG|Phase I: Everolimus will be administered as follows: Dose level 1: 5 mg every other day, Dose level 2: 5 mg daily, Dose level 3: 10 mg daily Phase II: Everolimus will be administered at the dose determined in Phase I.
295435|NCT01259063|O1|Outcome|Pts Who Failed or Relapsed After Intravesical BCG|Phase I: Everolimus will be administered as follows: Dose level 1: 5 mg every other day, Dose level 2: 5 mg daily, Dose level 3: 10 mg daily Phase II: Everolimus will be administered at the dose determined in Phase I.
295436|NCT01259063|O1|Outcome|Pts Who Failed or Relapsed After Intravesical BCG|Phase I: Everolimus will be administered as follows: Dose level 1: 5 mg every other day, Dose level 2: 5 mg daily, Dose level 3: 10 mg daily Phase II: Everolimus will be administered at the dose determined in Phase I.
295437|NCT01259063|O1|Outcome|Pts Who Failed or Relapsed After Intravesical BCG|Phase I: Everolimus will be administered as follows: Dose level 1: 5 mg every other day, Dose level 2: 5 mg daily, Dose level 3: 10 mg daily Phase II: Everolimus will be administered at the dose determined in Phase I.
295438|NCT01259063|O1|Outcome|Pts Who Failed or Relapsed After Intravesical BCG|Phase I: Everolimus will be administered as follows: Dose level 1: 5 mg every other day, Dose level 2: 5 mg daily, Dose level 3: 10 mg daily Phase II: Everolimus will be administered at the dose determined in Phase I.
295439|NCT01259063|O1|Outcome|Pts Who Failed or Relapsed After Intravesical BCG|Phase I: Everolimus will be administered as follows: Dose level 1: 5 mg every other day, Dose level 2: 5 mg daily, Dose level 3: 10 mg daily Phase II: Everolimus will be administered at the dose determined in Phase I.
295440|NCT01259063|E1|Reported Event|Pts Who Failed or Relapsed After Intravesical BCG|Phase I: Everolimus will be administered as follows: Dose level 1: 5 mg every other day, Dose level 2: 5 mg daily, Dose level 3: 10 mg daily Phase II: Everolimus will be administered at the dose determined in Phase I.
295441|NCT01259024|B1|Baseline|Doxorubicin-eluting LC Bead|"transarterial chemoembolization using doxorubicin-eluting LC Beads~transarterial chemoembolization using a drug-eluting bead: Up to 2 vials of LC Beads will be administered. One 2 mL vial each of 300-500 and 500-700 um LC Beads with 37.5 mg/mL doxorubicin will be prepared and mixed with radiographic contrast. Under fluoroscopic control, the vial of 300-500 um vial will be infused, followed by the vial of 500-700 um LC Beads. If the artery does not reach stasis prior to administration of both vials, and there is residual antegrade flow in the feeding artery, it will be treated with bland embolization similar to chemoembolization."
295442|NCT01259024|P1|Participant Flow|Doxorubicin-eluting LC Bead|"transarterial chemoembolization using doxorubicin-eluting LC Beads~transarterial chemoembolization using a drug-eluting bead: Up to 2 vials of LC Beads will be administered. One 2 mL vial each of 300-500 and 500-700 um LC Beads with 37.5 mg/mL doxorubicin will be prepared and mixed with radiographic contrast. Under fluoroscopic control, the vial of 300-500 um vial will be infused, followed by the vial of 500-700 um LC Beads. If the artery does not reach stasis prior to administration of both vials, and there is residual antegrade flow in the feeding artery, it will be treated with bland embolization similar to chemoembolization."
295443|NCT01259024|O1|Outcome|Doxorubicin-eluting LC Bead|"transarterial chemoembolization using doxorubicin-eluting LC Beads~transarterial chemoembolization using a drug-eluting bead: Up to 2 vials of LC Beads will be administered. One 2 mL vial each of 300-500 and 500-700 um LC Beads with 37.5 mg/mL doxorubicin will be prepared and mixed with radiographic contrast. Under fluoroscopic control, the vial of 300-500 um vial will be infused, followed by the vial of 500-700 um LC Beads. If the artery does not reach stasis prior to administration of both vials, and there is residual antegrade flow in the feeding artery, it will be treated with bland embolization similar to chemoembolization."
295444|NCT01259024|O1|Outcome|Doxorubicin-eluting LC Bead|"transarterial chemoembolization using doxorubicin-eluting LC Beads~transarterial chemoembolization using a drug-eluting bead: Up to 2 vials of LC Beads will be administered. One 2 mL vial each of 300-500 and 500-700 um LC Beads with 37.5 mg/mL doxorubicin will be prepared and mixed with radiographic contrast. Under fluoroscopic control, the vial of 300-500 um vial will be infused, followed by the vial of 500-700 um LC Beads. If the artery does not reach stasis prior to administration of both vials, and there is residual antegrade flow in the feeding artery, it will be treated with bland embolization similar to chemoembolization."
295445|NCT01259024|O1|Outcome|Doxorubicin-eluting LC Bead|"transarterial chemoembolization using doxorubicin-eluting LC Beads~transarterial chemoembolization using a drug-eluting bead: Up to 2 vials of LC Beads will be administered. One 2 mL vial each of 300-500 and 500-700 um LC Beads with 37.5 mg/mL doxorubicin will be prepared and mixed with radiographic contrast. Under fluoroscopic control, the vial of 300-500 um vial will be infused, followed by the vial of 500-700 um LC Beads. If the artery does not reach stasis prior to administration of both vials, and there is residual antegrade flow in the feeding artery, it will be treated with bland embolization similar to chemoembolization."
295446|NCT01259024|O1|Outcome|Doxorubicin-eluting LC Bead|"transarterial chemoembolization using doxorubicin-eluting LC Beads~transarterial chemoembolization using a drug-eluting bead: Up to 2 vials of LC Beads will be administered. One 2 mL vial each of 300-500 and 500-700 um LC Beads with 37.5 mg/mL doxorubicin will be prepared and mixed with radiographic contrast. Under fluoroscopic control, the vial of 300-500 um vial will be infused, followed by the vial of 500-700 um LC Beads. If the artery does not reach stasis prior to administration of both vials, and there is residual antegrade flow in the feeding artery, it will be treated with bland embolization similar to chemoembolization."
295447|NCT01259024|E1|Reported Event|Doxorubicin-eluting LC Bead|"transarterial chemoembolization using doxorubicin-eluting LC Beads~transarterial chemoembolization using a drug-eluting bead: Up to 2 vials of LC Beads will be administered. One 2 mL vial each of 300-500 and 500-700 um LC Beads with 37.5 mg/mL doxorubicin will be prepared and mixed with radiographic contrast. Under fluoroscopic control, the vial of 300-500 um vial will be infused, followed by the vial of 500-700 um LC Beads. If the artery does not reach stasis prior to administration of both vials, and there is residual antegrade flow in the feeding artery, it will be treated with bland embolization similar to chemoembolization."
295448|NCT01259011|B3|Baseline|Total|Total of all reporting groups
295449|NCT01259011|B2|Baseline|SPIRIT Intervention|the SPIRIT intervention: the SPIRIT intervention (Sharing the Patient's Illness Representation to Increase Trust) to improve discussions about end-of-life care between patients and their surrogate decision makers
295468|NCT01258985|P2|Participant Flow|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
295450|NCT01259011|B1|Baseline|Control|As required by Medicare and Medicaid programs (conditions for coverage for ESRD facilities), written information on advance directives and the patient’s right to have an advance directive is provided to every patient on the first day of dialysis treatment by a social worker at the clinic. Also, the social worker documents whether the patient has an advance directive, a surrogate decision maker, and/or a Do-Not-Resuscitate (DNR) Order on a Comprehensive Interdisciplinary Assessment form. The social worker encourages patients to complete an advance directive and addresses their questions about life-sustaining treatment options. If completed, the advance directive is placed in the medical record.
295451|NCT01259011|P2|Participant Flow|SPIRIT Intervention|the SPIRIT intervention: the SPIRIT intervention (Sharing the Patient's Illness Representation to Increase Trust) to improve discussions about end-of-life care between patients and their surrogate decision makers
295452|NCT01259011|P1|Participant Flow|Control|As required by Medicare and Medicaid programs (conditions for coverage for ESRD facilities), written information on advance directives and the patient’s right to have an advance directive is provided to every patient on the first day of dialysis treatment by a social worker at the clinic. Also, the social worker documents whether the patient has an advance directive, a surrogate decision maker, and/or a Do-Not-Resuscitate (DNR) Order on a Comprehensive Interdisciplinary Assessment form. The social worker encourages patients to complete an advance directive and addresses their questions about life-sustaining treatment options. If completed, the advance directive is placed in the medical record.
295453|NCT01259011|O2|Outcome|SPIRIT Intervention|"The SPIRIT intervention is a two-session, 1½ hour–long, structured intervention that is composed of six steps (assessing representations, identifying and exploring gaps and concerns, creating conditions for conceptual change, introducing replacement information, summarizing, and setting goals and planning), presented to both patient and surrogate by a trained nurse interventionist in a face-to-face interview format based on the representational approach.~the SPIRIT intervention: the SPIRIT intervention (Sharing the Patient's Illness Representation to Increase Trust) to improve discussions about end-of-life care between patients and their surrogate decision makers"
295454|NCT01259011|O1|Outcome|Control|Written information on advance directives and the patient’s right to have an advance directive is provided to every patient on the first day of dialysis treatment by a social worker at the clinic. A social worker documents whether the patient has an advance directive, a surrogate decision maker, and/or a Do-Not-Resuscitate (DNR) Order on a Comprehensive Interdisciplinary Assessment form. The social worker encourages patients to complete an advance directive and addresses their questions about life-sustaining treatment options. If completed, the advance directive is placed in the medical record.
295455|NCT01259011|O2|Outcome|SPIRIT Intervention|"The SPIRIT intervention is a two-session, 1½ hour–long, structured intervention that is composed of six steps (assessing representations, identifying and exploring gaps and concerns, creating conditions for conceptual change, introducing replacement information, summarizing, and setting goals and planning), presented to both patient and surrogate by a trained nurse interventionist in a face-to-face interview format based on the representational approach.~the SPIRIT intervention: the SPIRIT intervention (Sharing the Patient's Illness Representation to Increase Trust) to improve discussions about end-of-life care between patients and their surrogate decision makers"
295456|NCT01259011|O1|Outcome|Control|Written information on advance directives and the patient’s right to have an advance directive is provided to every patient on the first day of dialysis treatment by a social worker at the clinic. A social worker documents whether the patient has an advance directive, a surrogate decision maker, and/or a Do-Not-Resuscitate (DNR) Order on a Comprehensive Interdisciplinary Assessment form. The social worker encourages patients to complete an advance directive and addresses their questions about life-sustaining treatment options. If completed, the advance directive is placed in the medical record.
295457|NCT01259011|O2|Outcome|SPIRIT Intervention|the SPIRIT intervention: the SPIRIT intervention (Sharing the Patient's Illness Representation to Increase Trust) to improve discussions about end-of-life care between patients and their surrogate decision makers
295458|NCT01259011|O1|Outcome|Control|As required by Medicare and Medicaid programs (conditions for coverage for ESRD facilities), written information on advance directives and the patient’s right to have an advance directive is provided to every patient on the first day of dialysis treatment by a social worker at the clinic. Also, the social worker documents whether the patient has an advance directive, a surrogate decision maker, and/or a Do-Not-Resuscitate (DNR) Order on a Comprehensive Interdisciplinary Assessment form. The social worker encourages patients to complete an advance directive and addresses their questions about life-sustaining treatment options. If completed, the advance directive is placed in the medical record.
295459|NCT01259011|E2|Reported Event|SPIRIT Intervention|the SPIRIT intervention: the SPIRIT intervention (Sharing the Patient's Illness Representation to Increase Trust) to improve discussions about end-of-life care between patients and their surrogate decision makers
295460|NCT01259011|E1|Reported Event|Control|As required by Medicare and Medicaid programs (conditions for coverage for ESRD facilities), written information on advance directives and the patient’s right to have an advance directive is provided to every patient on the first day of dialysis treatment by a social worker at the clinic. Also, the social worker documents whether the patient has an advance directive, a surrogate decision maker, and/or a Do-Not-Resuscitate (DNR) Order on a Comprehensive Interdisciplinary Assessment form. The social worker encourages patients to complete an advance directive and addresses their questions about life-sustaining treatment options. If completed, the advance directive is placed in the medical record.
295461|NCT01258998|B1|Baseline|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
295462|NCT01258998|P1|Participant Flow|Akt Inhibitor MK2206|Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
295463|NCT01258998|O1|Outcome|Akt Inhibitor MK2206|Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
295464|NCT01258998|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 orally once a week, repeats every 28 days for up to 12 courses.
295465|NCT01258985|B3|Baseline|Total|Total of all reporting groups
295466|NCT01258985|B2|Baseline|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
295467|NCT01258985|B1|Baseline|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
295470|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
295471|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
295472|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
295473|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
295474|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
295475|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
295476|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
295477|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
295478|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
295479|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
295480|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
295481|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
295482|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
295483|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
295484|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
295485|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
295486|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
295487|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
295488|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
295489|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
295490|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
295491|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
295492|NCT01258985|E2|Reported Event|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
295493|NCT01258985|E1|Reported Event|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
295494|NCT01258803|B1|Baseline|All Randomized Participants|
295495|NCT01258803|P6|Participant Flow|Treatment Sequence 6|Treatment Period 1: MF/F MDI with spacer, Treatment Period 2: Placebo MDI without spacer, Treatment Period 3: MF/F MDI without spacer, Treatment Period 4: F DPI
295496|NCT01258803|P5|Participant Flow|Treatment Sequence 5|Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI without spacer
295497|NCT01258803|P4|Participant Flow|Treatment Sequence 4|Treatment Period 1: Placebo MDI without spacer, Treatment Period 2: MF/F MDI with spacer, Treatment Period 3: F DPI, Treatment Period 4: MF/F MDI without spacer
295498|NCT01258803|P3|Participant Flow|Treatment Sequence 3|Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: Placebo MDI with spacer, Treatment Period 4: MF/F MDI with spacer
295499|NCT01258803|P2|Participant Flow|Treatment Sequence 2|Treatment Period 1: F DPI, Treatment Period 2: MF/F MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI with spacer
295500|NCT01258803|P1|Participant Flow|Treatment Sequence 1|Treatment Period 1: Placebo Metered Dose Inhaler (MDI) with spacer, Treatment Period 2: Mometasone Furoate/Formoterol Fumarate (MF/F) MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: F Dry Powder Inhaler (DPI)
295501|NCT01258803|O4|Outcome|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
295502|NCT01258803|O3|Outcome|F DPI|Participants receiving a single dose of F DPI 20 mcg
295503|NCT01258803|O2|Outcome|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
295504|NCT01258803|O1|Outcome|MF/F MDI With Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
295505|NCT01258803|O2|Outcome|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
295506|NCT01258803|O1|Outcome|F DPI|Participants receiving a single dose of F DPI 20 mcg
295507|NCT01258803|O2|Outcome|F DPI|Participants receiving a single dose of F DPI 20 mcg
295508|NCT01258803|O1|Outcome|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
295509|NCT01258803|O2|Outcome|F DPI|Participants receiving a single dose of F DPI 20 mcg
295510|NCT01258803|O1|Outcome|MF/F MDI With Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
295511|NCT01258803|O4|Outcome|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
295521|NCT01258803|E4|Reported Event|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
295522|NCT01258803|E3|Reported Event|F DPI|Participants receiving a single dose of F DPI 20 mcg
295523|NCT01258803|E2|Reported Event|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
295524|NCT01258803|E1|Reported Event|MF/F MDI With Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
295525|NCT01258790|B3|Baseline|Total|Total of all reporting groups
295526|NCT01258790|B2|Baseline|Sham Repetitive Transcranial Magnetic Stimulation|In the sham arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim sham 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
295527|NCT01258790|B1|Baseline|Active Repetitive Transcranial Magnetic Stimulation|In the active arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
295528|NCT01258790|P2|Participant Flow|Sham Repetitive Transcranial Magnetic Stimulation|In the sham arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim sham 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
295529|NCT01258790|P1|Participant Flow|Active Repetitive Transcranial Magnetic Stimulation|In the active arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
295530|NCT01258790|O2|Outcome|Sham Repetitive Transcranial Magnetic Stimulation|In the sham arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim sham 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
295531|NCT01258790|O1|Outcome|Active Repetitive Transcranial Magnetic Stimulation|In the active arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
295532|NCT01258790|E2|Reported Event|Sham Repetitive Transcranial Magnetic Stimulation|In the sham arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim sham 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
295533|NCT01258790|E1|Reported Event|Active Repetitive Transcranial Magnetic Stimulation|In the active arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
295534|NCT01258738|B3|Baseline|Total|Total of all reporting groups
295535|NCT01258738|B2|Baseline|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295536|NCT01258738|B1|Baseline|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295537|NCT01258738|P2|Participant Flow|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295538|NCT01258738|P1|Participant Flow|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295539|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295540|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295541|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295542|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295731|NCT01258387|B8|Baseline|GGF2 Seventh Escalataed Dose|Seventh dosing: patients in cohort randomized to GGF2
295543|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295544|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295545|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295546|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295547|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295548|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295549|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295550|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295551|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295552|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295553|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295554|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295555|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295556|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295557|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295558|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295559|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295560|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295561|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295562|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295563|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295564|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295565|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295566|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295567|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295568|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295569|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295570|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295571|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295572|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295573|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295574|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295575|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295576|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295577|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295578|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295579|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295580|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295581|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295582|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295583|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295584|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295585|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295586|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295587|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295588|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295589|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295590|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295591|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295592|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295593|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295594|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295595|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295596|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295597|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295598|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295599|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295600|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295601|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295602|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295603|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295604|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295605|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295606|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295607|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295608|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295609|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295610|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295611|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295612|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295613|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295614|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295615|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295616|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295617|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295618|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295619|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295620|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295621|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295622|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295623|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295624|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295625|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295626|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295627|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295628|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295629|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295630|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295631|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295632|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295633|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295634|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295635|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295636|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295637|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295638|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295639|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295640|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295641|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295642|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295643|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295644|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295645|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295646|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295647|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295648|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295649|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295650|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295651|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295652|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295653|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295654|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295655|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295656|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295657|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295658|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295659|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295660|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295661|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295662|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295663|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295664|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295665|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295666|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295667|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295668|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295669|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295670|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
295671|NCT01258738|E2|Reported Event|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period).
295672|NCT01258738|E1|Reported Event|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period).
295673|NCT01258660|B3|Baseline|Total|Total of all reporting groups
295674|NCT01258660|B2|Baseline|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
295675|NCT01258660|B1|Baseline|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
295732|NCT01258387|B7|Baseline|GGF2 Sixth Escalated Dose|Sixth dosing: patients in cohort randomized to GGF2.
295733|NCT01258387|B6|Baseline|GGF2 Fifth Escalated Dose|Fifth dosing: patients in cohort randomized to GGF2
295676|NCT01258660|P2|Participant Flow|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
295677|NCT01258660|P1|Participant Flow|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
295678|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
295679|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
295680|NCT01258660|O2|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
295681|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
295682|NCT01258660|O2|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
295683|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
295684|NCT01258660|O2|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
295685|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
295686|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
295687|NCT01258660|O2|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
295688|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
295734|NCT01258387|B5|Baseline|GGF2 Fourth Escalated Dose|Fourth dosing: patients in cohort randomized to GGF2
295689|NCT01258660|O2|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
295690|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
295691|NCT01258660|E2|Reported Event|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
295692|NCT01258660|E1|Reported Event|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
295693|NCT01258595|B3|Baseline|Total|Total of all reporting groups
295694|NCT01258595|B2|Baseline|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
295695|NCT01258595|B1|Baseline|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
295696|NCT01258595|P2|Participant Flow|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
295697|NCT01258595|P1|Participant Flow|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
295698|NCT01258595|O2|Outcome|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
295699|NCT01258595|O1|Outcome|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
295700|NCT01258595|O2|Outcome|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
295701|NCT01258595|O1|Outcome|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
295702|NCT01258595|O2|Outcome|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
295703|NCT01258595|O1|Outcome|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
295704|NCT01258595|O2|Outcome|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
295705|NCT01258595|O1|Outcome|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
295706|NCT01258595|O2|Outcome|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
295707|NCT01258595|O1|Outcome|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
295708|NCT01258595|E2|Reported Event|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
295709|NCT01258595|E1|Reported Event|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
295710|NCT01258582|B3|Baseline|Total|Total of all reporting groups
295711|NCT01258582|B2|Baseline|Oral Fluid|Oral fluid rapid HIV testing
295712|NCT01258582|B1|Baseline|Fingerstick|Fingerstick rapid HIV testing
295713|NCT01258582|P2|Participant Flow|Oral Fluid|Oral fluid rapid HIV testing
295714|NCT01258582|P1|Participant Flow|Fingerstick|Fingerstick rapid HIV testing
295715|NCT01258582|O2|Outcome|Oral HIV Testing|oral fluid rapid HIV testing
295716|NCT01258582|O1|Outcome|Fingerstick HIV Testing|whole-blood fingerstick rapid HIV testing
295717|NCT01258582|E2|Reported Event|Oral Fluid|Oral fluid rapid HIV testing
295718|NCT01258582|E1|Reported Event|Fingerstick|Fingerstick rapid HIV testing
295719|NCT01258504|B1|Baseline|Bosentan|bosentan 125 mg p.o. day 1 single dose bosentan 62.5 mg p.o. b.i.d. day 2-10 bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg p.o. t.i.d. day 11-20
295720|NCT01258504|P1|Participant Flow|Bosentan|bosentan 125 mg p.o. single dose day 1 bosentan 62.5 mg p.o. b.i.d. day 2-10 bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg p.o. t.i.d. day 11-20
295721|NCT01258504|O3|Outcome|Bosentan During St John's Wort|bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg t.i.d. day 11-20
295722|NCT01258504|O2|Outcome|Bosentan at Steady-state|bosentan 62.5 mg p.o. b.i.d. day 2-10
295723|NCT01258504|O1|Outcome|Bosentan After First Dose|bosentan125 mg p.o. day 1 single dose
295724|NCT01258504|O3|Outcome|Bosentan During St John's Wort|bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg t.i.d. day 11-20
295725|NCT01258504|O2|Outcome|Bosentan at Steady-state|bosentan 62.5 mg p.o. b.i.d. day 2-10
295726|NCT01258504|O1|Outcome|Bosentan After First Dose|bosentan 125 mg p.o. day 1 single dose
295727|NCT01258504|E3|Reported Event|Bosentan During St John's Wort|bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg t.i.d. day 11-20
295735|NCT01258387|B4|Baseline|GGF2 Third Escalated Dose|Third dosing: patients in cohort randomized to GGF2
295736|NCT01258387|B3|Baseline|GGF2 Second Escalated Dose|Second dosing: patients in cohort randomized to GGF2
295737|NCT01258387|B2|Baseline|GGF2 First Dose|First dosing: patients in cohort randomized to GGF2
295738|NCT01258387|B1|Baseline|Placebo|Patients in each of 7 cohorts randomized to Placebo
295739|NCT01258387|P7|Participant Flow|GGF2 Seventh Escalataed Dose|Seventh dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
295740|NCT01258387|P6|Participant Flow|GGF2 Sixth Escalated Dose|Sixth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed .
295741|NCT01258387|P5|Participant Flow|GGF2 Fifth Escalated Dose|Fifth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
295742|NCT01258387|P4|Participant Flow|GGF2 Fourth Escalated Dose|Fourth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
295743|NCT01258387|P3|Participant Flow|GGF2 Third Escalated Dose|Third dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
295744|NCT01258387|P2|Participant Flow|GGF2 Second Escalated Dose|Second dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
295745|NCT01258387|P1|Participant Flow|GGF2 First Dose|First dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
295746|NCT01258387|O8|Outcome|GGF2 Seventh Escalataed Dose|
295747|NCT01258387|O7|Outcome|GGF2 Sixth Escalated Dose|
295748|NCT01258387|O6|Outcome|GGF2 Fifth Escalated Dose|
295749|NCT01258387|O5|Outcome|GGF2 Fourth Escalated Dose|
295750|NCT01258387|O4|Outcome|GGF2 Third Escalated Dose|
295751|NCT01258387|O3|Outcome|GGF2 Second Escalated Dose|
295752|NCT01258387|O2|Outcome|GGF2 First Dose|
295753|NCT01258387|O1|Outcome|Placebo|
295754|NCT01258387|O8|Outcome|GGF2 Seventh Escalataed Dose|
295755|NCT01258387|O7|Outcome|GGF2 Sixth Escalated Dose|
295756|NCT01258387|O6|Outcome|GGF2 Fifth Escalated Dose|
295757|NCT01258387|O5|Outcome|GGF2 Fourth Escalated Dose|
295758|NCT01258387|O4|Outcome|GGF2 Third Escalated Dose|
295759|NCT01258387|O3|Outcome|GGF2 Second Escalated Dose|
295760|NCT01258387|O2|Outcome|GGF2 First Dose|
295761|NCT01258387|O1|Outcome|Placebo|
295762|NCT01258387|O8|Outcome|GGF2 Seventh Escalataed Dose|
295763|NCT01258387|O7|Outcome|GGF2 Sixth Escalated Dose|
295764|NCT01258387|O6|Outcome|GGF2 Fifth Escalated Dose|
295765|NCT01258387|O5|Outcome|GGF2 Fourth Escalated Dose|
295766|NCT01258387|O4|Outcome|GGF2 Third Escalated Dose|
295767|NCT01258387|O3|Outcome|GGF2 Second Escalated Dose|
295768|NCT01258387|O2|Outcome|GGF2 First Dose|
295769|NCT01258387|O1|Outcome|Placebo|
295770|NCT01258387|O8|Outcome|GGF2 Seventh Escalataed Dose|
295771|NCT01258387|O7|Outcome|GGF2 Sixth Escalated Dose|
295772|NCT01258387|O6|Outcome|GGF2 Fifth Escalated Dose|
295773|NCT01258387|O5|Outcome|GGF2 Fourth Escalated Dose|
295774|NCT01258387|O4|Outcome|GGF2 Third Escalated Dose|
295775|NCT01258387|O3|Outcome|GGF2 Second Escalated Dose|
295776|NCT01258387|O2|Outcome|GGF2 First Dose|
295777|NCT01258387|O1|Outcome|Placebo|
295778|NCT01258387|E8|Reported Event|GGF2 Seventh Escalataed Dose|Seventh dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
295779|NCT01258387|E7|Reported Event|GGF2 Sixth Escalated Dose|Sixth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed .
295780|NCT01258387|E6|Reported Event|GGF2 Fifth Escalated Dose|Fifth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
295781|NCT01258387|E5|Reported Event|GGF2 Fourth Escalated Dose|Fourth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
295782|NCT01258387|E4|Reported Event|GGF2 Third Escalated Dose|Third dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
295783|NCT01258387|E3|Reported Event|GGF2 Second Escalated Dose|Second dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
295784|NCT01258387|E2|Reported Event|GGF2 First Dose|First dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
295785|NCT01258387|E1|Reported Event|Placebo|
295786|NCT01258153|B4|Baseline|Total|Total of all reporting groups
295787|NCT01258153|B3|Baseline|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
295788|NCT01258153|B2|Baseline|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
295789|NCT01258153|B1|Baseline|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
295790|NCT01258153|P3|Participant Flow|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
295791|NCT01258153|P2|Participant Flow|Nepadutant High Dose|Nepadutant oral solution 0.5mg/kg: Oral administration once daily for 7 days
295792|NCT01258153|P1|Participant Flow|Nepadutant Low Dose|Nepadutant oral solution 0.1mg/kg: Oral administration once daily for 7 days
295793|NCT01258153|O3|Outcome|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
295794|NCT01258153|O2|Outcome|Nepadutant High Dose|Nepadutant oral solution 0.5mg/kg: Oral administration once daily for 7 days
295795|NCT01258153|O1|Outcome|Nepadutant Low Dose|Nepadutant oral solution 0.1mg/kg: Oral administration once daily for 7 days
295796|NCT01258153|O3|Outcome|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
295797|NCT01258153|O2|Outcome|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
295798|NCT01258153|O1|Outcome|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
295799|NCT01258153|O3|Outcome|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
295800|NCT01258153|O2|Outcome|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
295801|NCT01258153|O1|Outcome|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
295802|NCT01258153|O3|Outcome|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
295803|NCT01258153|O2|Outcome|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
295804|NCT01258153|O1|Outcome|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
295805|NCT01258153|O3|Outcome|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
295806|NCT01258153|O2|Outcome|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
295807|NCT01258153|O1|Outcome|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
295808|NCT01258153|O3|Outcome|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
295809|NCT01258153|O2|Outcome|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
295810|NCT01258153|O1|Outcome|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
295811|NCT01258153|E3|Reported Event|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
295812|NCT01258153|E2|Reported Event|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
295813|NCT01258153|E1|Reported Event|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
295814|NCT01258101|B5|Baseline|Total|Total of all reporting groups
295815|NCT01258101|B4|Baseline|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295816|NCT01258101|B3|Baseline|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295817|NCT01258101|B2|Baseline|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
295818|NCT01258101|B1|Baseline|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
295819|NCT01258101|P4|Participant Flow|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295820|NCT01258101|P3|Participant Flow|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295821|NCT01258101|P2|Participant Flow|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
295822|NCT01258101|P1|Participant Flow|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered peginterferon alfa-2a (PEG-IFNα-2a) 180 microgram (mcg) subcutaneously (SC) once weekly + Ribavirin 800 milligram (mg) orally daily for 24 weeks (W). The untreated Follow-up was for 24 W.
295823|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295824|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295825|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
295826|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
295827|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295828|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295829|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
295830|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
295831|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295832|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295833|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
296365|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
295834|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
295835|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295836|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295837|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
295838|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
295839|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295840|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295841|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
295842|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
295843|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295844|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295845|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
295846|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
295847|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295848|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295849|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
295850|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
295851|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295852|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295853|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
295854|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
295855|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295856|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295857|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
295858|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
295859|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295860|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295861|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
295862|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
295863|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295864|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295865|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
295866|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
295867|NCT01258101|E4|Reported Event|Ribavirin 400 mg/16W|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295868|NCT01258101|E3|Reported Event|Ribavirin 800 mg/16W|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
295869|NCT01258101|E2|Reported Event|Ribavirin 400 mg/24W|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
295870|NCT01258101|E1|Reported Event|Ribavirin 800 mg/24W|Eligible participants were administered peginterferon alfa-2a (PEG-IFNα-2a) 180 microgram (mcg) subcutaneously (SC) once weekly + Ribavirin 800 milligram (mg) orally daily for 24 weeks (W). The untreated Follow-up was for 24 W.
295871|NCT01258049|B3|Baseline|Total|Total of all reporting groups
295872|NCT01258049|B2|Baseline|Quinine|A loading dose of 20 mg/kg was given over four hours and thereafter 10 mg/kg was given every eight hours until the subject was able to swallow. Thereafter, patients were given quinine syrup or crushed tablets (10 mg/kg every eight hours) or another suitable treatment to ensure they received at least seven days of therapy, or be converted to another suitable treatment or a suitable course of combination therapy, in accordance with national drugs policy where applicable
295873|NCT01258049|B1|Baseline|ArTiMist|"Doses of 3 mg/kg were administered sublingually at: 0 h, 8 h, 24 h, 36 h, 48 h, and 60 h.~Following the initial six doses, subjects could, at the discretion of the Investigator receive a further four daily doses of 3 mg/kg ArTiMist™ to complete a seven day treatment course, or be converted to another suitable treatment or a suitable course of combination therapy in accordance with national drugs policy where applicable."
295874|NCT01258049|P2|Participant Flow|Quinine|A loading dose of 20 mg/kg was given over four hours and thereafter 10 mg/kg was given every eight hours until the subject was able to swallow. Thereafter, patients were given quinine syrup or crushed tablets (10 mg/kg every eight hours) or another suitable treatment to ensure they received at least seven days of therapy, or be converted to another suitable treatment or a suitable course of combination therapy, in accordance with national drugs policy where applicable.
295875|NCT01258049|P1|Participant Flow|ArTiMist|Doses of 3 mg/kg were administered sublingually at: 0 h, 8 h, 24 h, 36 h, 48 h, and 60 h. Following the initial six doses, subjects could, at the discretion of the Investigator receive a further four daily doses of 3 mg/kg ArTiMist™ to complete a seven day treatment course, or be converted to another suitable treatment or a suitable course of combination therapy in accordance with national drugs policy where applicable.
295876|NCT01258049|O2|Outcome|Quinine|
295877|NCT01258049|O1|Outcome|ArTiMist|
295878|NCT01258049|O2|Outcome|Quinine|
295879|NCT01258049|O1|Outcome|ArTiMist|
295880|NCT01258049|O2|Outcome|Quinine|
295881|NCT01258049|O1|Outcome|ArTiMist|
295882|NCT01258049|O2|Outcome|Quinine|
295883|NCT01258049|O1|Outcome|ArTiMist|
295884|NCT01258049|O2|Outcome|Quinine|
295885|NCT01258049|O1|Outcome|ArTiMist|
295886|NCT01258049|O2|Outcome|Quinine|
295887|NCT01258049|O1|Outcome|ArTiMist|
295888|NCT01258049|O2|Outcome|Quinine|
295889|NCT01258049|O1|Outcome|ArTiMist|
295890|NCT01258049|O2|Outcome|Quinine|
295891|NCT01258049|O1|Outcome|ArTiMist|
295892|NCT01258049|O2|Outcome|Quinine|
295893|NCT01258049|O1|Outcome|ArTiMist|
295894|NCT01258049|O2|Outcome|Quinine|
295895|NCT01258049|O1|Outcome|ArTiMist|
295896|NCT01258049|O2|Outcome|Quinine|
295897|NCT01258049|O1|Outcome|ArTiMist|
295898|NCT01258049|O2|Outcome|Quinine|
295899|NCT01258049|O1|Outcome|ArTiMist|
295900|NCT01258049|O2|Outcome|Quinine|
295901|NCT01258049|O1|Outcome|ArTiMist|
295902|NCT01258049|O2|Outcome|Quinine|
295903|NCT01258049|O1|Outcome|ArTiMist|
295904|NCT01258049|O2|Outcome|Quinine|
295905|NCT01258049|O1|Outcome|ArTiMist|
295906|NCT01258049|O2|Outcome|Quinine|
295907|NCT01258049|O1|Outcome|ArTiMist|
295908|NCT01258049|E2|Reported Event|Quinine|
295909|NCT01258049|E1|Reported Event|ArTiMist|
295910|NCT01257880|B3|Baseline|Total|Total of all reporting groups
295911|NCT01257880|B2|Baseline|Large PFO|Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
295912|NCT01257880|B1|Baseline|Control (Absence of PFO)|Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
295913|NCT01257880|P2|Participant Flow|Large PFO|Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
295914|NCT01257880|P1|Participant Flow|Control (Absence of PFO)|Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
295915|NCT01257880|O2|Outcome|Large PFO|Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
295916|NCT01257880|O1|Outcome|Control (Absence of PFO)|Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
295917|NCT01257880|O2|Outcome|Large PFO|Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
295918|NCT01257880|O1|Outcome|Control (Absence of PFO)|Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
295919|NCT01257880|E2|Reported Event|Large PFO|Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
295920|NCT01257880|E1|Reported Event|Control (Absence of PFO)|Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
295921|NCT01257802|B3|Baseline|Total|Total of all reporting groups
296489|NCT01256411|B2|Baseline|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
295922|NCT01257802|B2|Baseline|Placebo|"depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses~Placebo: Monthly placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses"
295923|NCT01257802|B1|Baseline|LUPRON|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
295924|NCT01257802|P2|Participant Flow|Placebo|"depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses~Placebo: Monthly placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses"
295925|NCT01257802|P1|Participant Flow|LUPRON|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
295926|NCT01257802|O2|Outcome|PLACEBO|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
295927|NCT01257802|O1|Outcome|LUPRON|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
295928|NCT01257802|O2|Outcome|PLACEBO|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
295929|NCT01257802|O1|Outcome|LUPRON|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
295930|NCT01257802|O2|Outcome|PLACEBO|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
295931|NCT01257802|O1|Outcome|LUPRON|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
295932|NCT01257802|O2|Outcome|PLACEBO|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
295933|NCT01257802|O1|Outcome|LUPRON|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
295934|NCT01257802|O2|Outcome|Placebo|"depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses~Placebo: Monthly placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses"
295935|NCT01257802|O1|Outcome|LUPRON|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
295936|NCT01257802|E2|Reported Event|Placebo|"depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses~Placebo: Monthly placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses"
295937|NCT01257802|E1|Reported Event|LUPRON|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
295938|NCT01257750|B1|Baseline|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.~Frequency and Duration: 4 times per day for 3 weeks"
295939|NCT01257750|P1|Participant Flow|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.~Frequency and Duration: 4 times per day for 3 weeks"
295940|NCT01257750|O1|Outcome|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.~Frequency and Duration: 4 times per day for 3 weeks"
295941|NCT01257750|O1|Outcome|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.~Frequency and Duration: 4 times per day for 3 weeks"
295942|NCT01257750|O1|Outcome|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.~Frequency and Duration: 4 times per day for 3 weeks"
295943|NCT01257750|O1|Outcome|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.~Pazopanib (5mg/ml): Topical pazopanib, 4 times per day for 3 weeks"
295944|NCT01257750|O1|Outcome|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.~Frequency and Duration: 4 times per day for 3 weeks"
295945|NCT01257750|O1|Outcome|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.~Frequency and Duration: 4 times per day for 3 weeks"
295946|NCT01257750|O1|Outcome|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.~Frequency and Duration: 4 times per day for 3 weeks"
295947|NCT01257750|O1|Outcome|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.~Frequency and Duration: 4 times per day for 3 weeks"
295948|NCT01257750|E1|Reported Event|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.~Frequency and Duration: 4 times per day for 3 weeks"
295949|NCT01257737|B3|Baseline|Total|Total of all reporting groups
295950|NCT01257737|B2|Baseline|HPN-100 - Adult|Adult participants (age 19-61) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
295951|NCT01257737|B1|Baseline|HPN-100- Pediatric|Pediatric participants (age 1-17) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
295952|NCT01257737|P2|Participant Flow|HPN-100 - Adult|Adult participants (age 19-61) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
295953|NCT01257737|P1|Participant Flow|HPN-100- Pediatric|Pediatric participants (age 1-17) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
295954|NCT01257737|O1|Outcome|HPN-100 - Adult|Adult participants (age 19-61) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
295955|NCT01257737|O1|Outcome|HPN-100 - Adult|Adult participants (age 19-61) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
295956|NCT01257737|O1|Outcome|HPN-100- Pediatric|Pediatric participants (age 1-17) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
295957|NCT01257737|O1|Outcome|HPN-100- Pediatric|Pediatric participants (age 1-17) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
295958|NCT01257737|O2|Outcome|HPN-100 - Adult|Adult participants (age 19-61) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
295959|NCT01257737|O1|Outcome|HPN-100- Pediatric|Pediatric participants (age 1-17) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
295960|NCT01257737|O2|Outcome|HPN-100 - Adult|Adult participants (age 19-61) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
295961|NCT01257737|O1|Outcome|HPN-100- Pediatric|Pediatric participants (age 1-17) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
295962|NCT01257737|O2|Outcome|HPN-100 - Adult|Adult participants (age 19-61) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
295963|NCT01257737|O1|Outcome|HPN-100- Pediatric|Pediatric participants (age 1-17) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
295964|NCT01257737|O2|Outcome|HPN-100 - Adult|Adult participants (age 19-61) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
295965|NCT01257737|O1|Outcome|HPN-100- Pediatric|Pediatric participants (age 1-17) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
295966|NCT01257737|O2|Outcome|HPN-100 - Adult|Adult participants (age 19-61) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
295967|NCT01257737|O1|Outcome|HPN-100- Pediatric|Pediatric participants (age 1-17) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
295968|NCT01257737|E2|Reported Event|HPN-100 - Adult|Adult participants (age 19-61) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
295969|NCT01257737|E1|Reported Event|HPN-100- Pediatric|Pediatric participants (age 1-17) continued HPN-100 treatment after completion of HPN-100-005SE, HPN-100-007, or HPN-100-012SE.
295970|NCT01257581|B4|Baseline|Total|Total of all reporting groups
295971|NCT01257581|B3|Baseline|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
295972|NCT01257581|B2|Baseline|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
295973|NCT01257581|B1|Baseline|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
295974|NCT01257581|P3|Participant Flow|Tamoxifen 80mg|"Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.~This is a blinded study, so neither participants nor study staff will know which treatment a volunteer is receiving.~Tamoxifen is approved by the U.S. Food and Drug Administration (FDA) for breast cancer treatment but is not approved for treating ALS.~tamoxifen: Tamoxifen citrate capsules"
296001|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
296039|NCT01257503|O2|Outcome|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
295975|NCT01257581|P2|Participant Flow|Tamoxifen 40mg|"Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.~This is a blinded study, so neither participants nor study staff will know which treatment a volunteer is receiving.~Tamoxifen is approved by the U.S. Food and Drug Administration (FDA) for breast cancer treatment but is not approved for treating ALS.~tamoxifen: Tamoxifen citrate capsules"
295976|NCT01257581|P1|Participant Flow|Creatine 30gm|"Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.~This is a blinded study, so neither participants nor study staff will know which treatment a volunteer is receiving.~Creatine is a nutritional supplement and is not approved by the U.S. Food and Drug Administration (FDA) for treating ALS.~creatine: creatine monohydrate powder"
295977|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
295978|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
295979|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
295980|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
295981|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
295982|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
295983|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
295984|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
295985|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
295986|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
295987|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
295988|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
295989|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
295990|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
295991|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
295992|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
295993|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
295994|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
295995|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
295996|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
295997|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
295998|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
295999|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
296000|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
296002|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
296003|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
296004|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
296005|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
296006|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
296007|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
296008|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
296009|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
296010|NCT01257581|E3|Reported Event|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
296011|NCT01257581|E2|Reported Event|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
296012|NCT01257581|E1|Reported Event|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
296013|NCT01257542|B3|Baseline|Total|Total of all reporting groups
296014|NCT01257542|B2|Baseline|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
296015|NCT01257542|B1|Baseline|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
296016|NCT01257542|P2|Participant Flow|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
296017|NCT01257542|P1|Participant Flow|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
296018|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
296019|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
296020|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
296021|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
296022|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
296023|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
296024|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
296025|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
296026|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
296027|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
296028|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
296029|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
296030|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
296031|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
296032|NCT01257542|E2|Reported Event|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
296033|NCT01257542|E1|Reported Event|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
296034|NCT01257503|B3|Baseline|Total|Total of all reporting groups
296035|NCT01257503|B2|Baseline|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
296036|NCT01257503|B1|Baseline|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
296037|NCT01257503|P2|Participant Flow|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
296038|NCT01257503|P1|Participant Flow|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
296040|NCT01257503|O1|Outcome|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
296041|NCT01257503|O2|Outcome|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
296042|NCT01257503|O1|Outcome|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
296043|NCT01257503|O2|Outcome|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
296044|NCT01257503|O1|Outcome|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
296045|NCT01257503|O2|Outcome|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
296046|NCT01257503|O1|Outcome|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
296047|NCT01257503|O2|Outcome|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
296048|NCT01257503|O1|Outcome|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
296049|NCT01257503|E2|Reported Event|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
296050|NCT01257503|E1|Reported Event|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
296051|NCT01257438|B3|Baseline|Total|Total of all reporting groups
296052|NCT01257438|B2|Baseline|PTA Only|PTA only: Treatment of in-stent restenosis
296053|NCT01257438|B1|Baseline|Fluency|"Fluency Plus Endovascular Stent Graft~Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
296054|NCT01257438|P2|Participant Flow|PTA Only|PTA only: Treatment of in-stent restenosis
296055|NCT01257438|P1|Participant Flow|Fluency|"Fluency Plus Endovascular Stent Graft~Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
296056|NCT01257438|O2|Outcome|PTA Only|PTA only: Treatment of in-stent restenosis
296057|NCT01257438|O1|Outcome|Fluency|"Fluency Plus Endovascular Stent Graft~Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
296058|NCT01257438|O2|Outcome|PTA Only|PTA only: Treatment of in-stent restenosis
296059|NCT01257438|O1|Outcome|Fluency|"Fluency Plus Endovascular Stent Graft~Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
296060|NCT01257438|O2|Outcome|PTA Only|PTA only: Treatment of in-stent restenosis
296061|NCT01257438|O1|Outcome|Fluency|"Fluency Plus Endovascular Stent Graft~Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
296062|NCT01257438|E2|Reported Event|PTA Only|PTA only: Treatment of in-stent restenosis
296063|NCT01257438|E1|Reported Event|Fluency|"Fluency Plus Endovascular Stent Graft~Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
296064|NCT01257425|B3|Baseline|Total|Total of all reporting groups
296065|NCT01257425|B2|Baseline|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
296066|NCT01257425|B1|Baseline|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
296067|NCT01257425|P2|Participant Flow|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
296068|NCT01257425|P1|Participant Flow|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
296069|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
296070|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
296071|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
296072|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
296073|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
296074|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
296075|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
296076|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
296077|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
296078|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
296079|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
296080|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
296490|NCT01256411|B1|Baseline|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
296081|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
296082|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
296083|NCT01257425|E2|Reported Event|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
296084|NCT01257425|E1|Reported Event|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
296085|NCT01257347|B5|Baseline|Total|Total of all reporting groups
296086|NCT01257347|B4|Baseline|Electronically-Measuring Adherence Intervention: Patients|Patients with uncontrolled hypertension - during clinical visits, clinicians will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
296087|NCT01257347|B3|Baseline|Usual Care Control: Patients|Patients with uncontrolled hypertension - during clinical visits, clinicians will not be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
296088|NCT01257347|B2|Baseline|Electronically-measuring Adherence|Electronically-measuring adherence to antihypertensive medications: During clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings, and will list suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment.
296089|NCT01257347|B1|Baseline|Usual Care Control: Physicians|Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care.
296090|NCT01257347|P4|Participant Flow|Electronically-Measuring Adherence Intervention: Patients|Patients with uncontrolled hypertension - during clinical visits, clinicians will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
296091|NCT01257347|P3|Participant Flow|Usual Care Control: Patients|Patients with uncontrolled hypertension - during clinical visits, clinicians will not be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
296092|NCT01257347|P2|Participant Flow|Electronically-Measuring Adherence Intervention: Physicians|Electronically-measuring adherence to antihypertensive medications: During clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings, and will list suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment. 65 patients belonged to providers in the intervention group.
296093|NCT01257347|P1|Participant Flow|Usual Care Control: Physicians|Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care.35 patients belonged to providers in the control group.
296094|NCT01257347|O2|Outcome|Electronically-measuring Adherence Group, Non-adherent Only|At clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings. The report will also provide suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment.
296095|NCT01257347|O1|Outcome|Usual Care Control Group, Non-adherent Only|At clinical visits with patients with uncontrolled hypertension, clinicians will not be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. Clinicians will be expected to manage hypertension according to usual care.
296096|NCT01257347|O2|Outcome|Electronically-measuring Adherence Group, Non-adherent Only|At clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings. The report will also provide suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment.
296097|NCT01257347|O1|Outcome|Usual Care Control Group, Non-adherent Only|Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care.
296126|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296127|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
296098|NCT01257347|O2|Outcome|Electronically-measuring Adherence Group, Adherent Only|At clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings. The report will also provide suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment.
296099|NCT01257347|O1|Outcome|Usual Care Control Group, Adherent Only|At clinical visits with patients with uncontrolled hypertension, clinicians will not be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. Clinicians will be expected to manage hypertension according to usual care.
296100|NCT01257347|O2|Outcome|Electronically-measuring Adherence|At clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings. The report will also provide suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment.
296101|NCT01257347|O1|Outcome|Usual Care Control Group|Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care.
296102|NCT01257347|E4|Reported Event|Electronically-Measuring Adherence Intervention: Patients|Patients with uncontrolled hypertension - during clinical visits, clinicians will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
296103|NCT01257347|E3|Reported Event|Usual Care Control: Patients|Patients with uncontrolled hypertension - during clinical visits, clinicians will not be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
296104|NCT01257347|E2|Reported Event|Electronically-Measuring Adherence Intervention: Physicians|Electronically-measuring adherence to antihypertensive medications: During clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings, and will list suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment. 65 patients belonged to providers in the intervention group.
296105|NCT01257347|E1|Reported Event|Usual Care Control: Physicians|Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care. 35 patients belonged to providers in the control group.
296106|NCT01257230|B4|Baseline|Total|Total of all reporting groups
296107|NCT01257230|B3|Baseline|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296108|NCT01257230|B2|Baseline|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296109|NCT01257230|B1|Baseline|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
296110|NCT01257230|P3|Participant Flow|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler.
296111|NCT01257230|P2|Participant Flow|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296112|NCT01257230|P1|Participant Flow|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
296113|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296114|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296115|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
296116|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296117|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296118|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
296119|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296120|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296121|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
296122|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296123|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296124|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
296125|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296128|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296129|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296130|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
296131|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296132|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296133|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
296134|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296135|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296136|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
296137|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296138|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296139|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
296140|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296141|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296142|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
296143|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296144|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks delivered by the Respimat Inhaler
296145|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
296146|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296147|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296148|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
296149|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296150|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296151|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
296152|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296153|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296154|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
296155|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296156|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296157|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
296158|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296159|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296160|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
296161|NCT01257230|E3|Reported Event|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296162|NCT01257230|E2|Reported Event|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
296163|NCT01257230|E1|Reported Event|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
296164|NCT01257217|B3|Baseline|Total|Total of all reporting groups
296165|NCT01257217|B2|Baseline|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
296166|NCT01257217|B1|Baseline|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
296167|NCT01257217|P2|Participant Flow|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
296168|NCT01257217|P1|Participant Flow|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
296169|NCT01257217|O2|Outcome|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
296170|NCT01257217|O1|Outcome|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
296171|NCT01257217|O4|Outcome|Acri.LISA/With|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids
296564|NCT01256190|B2|Baseline|Gelatin Sponge|approved device for surgical bleeding
296172|NCT01257217|O3|Outcome|Acri.LISA/Without|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation, without corrective aids
296173|NCT01257217|O2|Outcome|ReSTOR +3/With|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids
296174|NCT01257217|O1|Outcome|ReSTOR +3/Without|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation, without corrective aids
296175|NCT01257217|O2|Outcome|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
296176|NCT01257217|O1|Outcome|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
296177|NCT01257217|O2|Outcome|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
296178|NCT01257217|O1|Outcome|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
296179|NCT01257217|O2|Outcome|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
296180|NCT01257217|O1|Outcome|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
296181|NCT01257217|O2|Outcome|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
296182|NCT01257217|O1|Outcome|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
296183|NCT01257217|E2|Reported Event|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL
296184|NCT01257217|E1|Reported Event|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
296185|NCT01257204|B4|Baseline|Total|Total of all reporting groups
296186|NCT01257204|B3|Baseline|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
296187|NCT01257204|B2|Baseline|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
296188|NCT01257204|B1|Baseline|Dacalatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
296189|NCT01257204|P3|Participant Flow|Placebo|Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks.
296190|NCT01257204|P2|Participant Flow|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks.
296191|NCT01257204|P1|Participant Flow|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα­2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 12 weeks.
296192|NCT01257204|O3|Outcome|Placebo: Follow-up|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks during treatment period and entered into the follow-up period.
296193|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort: Follow-up|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks during treatment period and entered into the follow-up period.
296194|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort: Follow-up|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks during treatment period and entered into the follow-up period.
296195|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
296196|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
296197|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
296198|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
296199|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
296200|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
296201|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
296202|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
296203|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
296204|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, along with pegIFNα­2a solution for injection 180 mcg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
296205|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
296206|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
296207|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
296208|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
296209|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
296210|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
296211|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
296212|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
296213|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
296214|NCT01257204|O2|Outcome|Dacalatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
296215|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
296216|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
296217|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
296218|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
296219|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
296220|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
296221|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 week s.
296222|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
296223|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
296312|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
296313|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
296224|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
296225|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
296226|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
296227|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
296228|NCT01257204|E6|Reported Event|Placebo: Follow-up|Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks during treatment period and entered into the follow-up period.
296229|NCT01257204|E5|Reported Event|Daclatasvir, 60 mg, 16-Week Cohort: Follow-up|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks during treatment period and entered into the follow-up period.
296230|NCT01257204|E4|Reported Event|Daclatasvir, 60 mg, 12-Week Cohort: Follow-up|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks during treatment period and entered into the follow-up period.
296231|NCT01257204|E3|Reported Event|Placebo|Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks.
296232|NCT01257204|E2|Reported Event|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks.
296233|NCT01257204|E1|Reported Event|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 12 weeks.
296234|NCT01256983|B3|Baseline|Total|Total of all reporting groups
296235|NCT01256983|B2|Baseline|No Intervention|10000 Lux after day 63
296236|NCT01256983|B1|Baseline|Light Box|"10000 lux after day 21~Light Box : 10000 Lux for 30 Minutes according to sleep wake rhythm"
296237|NCT01256983|P2|Participant Flow|No Intervention|10000 Lux after day 63
296238|NCT01256983|P1|Participant Flow|Light Box|"10000 lux after day 21~Light Box : 10000 Lux for 30 Minutes according to sleep wake rhythm"
296239|NCT01256983|O2|Outcome|No Intervention|10000 Lux after day 63
296240|NCT01256983|O1|Outcome|Light Box|"10000 lux after day 21~Light Box : 10000 Lux for 30 Minutes according to sleep wake rhythm"
296241|NCT01256983|E2|Reported Event|Wait-list Intervention|Wait-list design Intervention. Bright Light Therapy with 10000 lux beginning at day 63 until day 84, when the 9 study weeks were over.
296242|NCT01256983|E1|Reported Event|Bright Light Therapy|Bright Light Therapy with 10000 lux beginning at day 21 until day 42
296243|NCT01256944|B3|Baseline|Total|Total of all reporting groups
296244|NCT01256944|B2|Baseline|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
296245|NCT01256944|B1|Baseline|Control|The normal women
296246|NCT01256944|P2|Participant Flow|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing’s syndrome)"
296247|NCT01256944|P1|Participant Flow|Control|The normal women
296248|NCT01256944|O4|Outcome|Nonb-obese With Control|BMI categorization was based on the WHO Asia–Pacific classification for obesity, which was defined as BMI < 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
296249|NCT01256944|O3|Outcome|Non-obese With PCOS|"BMI categorization was based on the WHO Asia–Pacific classification for obesity, which was defined as BMI < 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).~Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
296250|NCT01256944|O2|Outcome|Obese With Control|BMI categorization was based on the WHO Asia–Pacific classification for obesity, which was defined as BMI ≧ 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
296251|NCT01256944|O1|Outcome|Obese With PCOS|"BMI categorization was based on the WHO Asia–Pacific classification for obesity, which was defined as BMI ≧ 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).~Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
296252|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
296253|NCT01256944|O1|Outcome|Control|The normal women
296254|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
296255|NCT01256944|O1|Outcome|Control|The normal women
296256|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
296257|NCT01256944|O1|Outcome|Control|The normal women
296258|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
296259|NCT01256944|O1|Outcome|Control|The normal women
296260|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
296261|NCT01256944|O1|Outcome|Control|The normal women
296262|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
296263|NCT01256944|O1|Outcome|Control|The normal women
296264|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
296265|NCT01256944|O1|Outcome|Control|The normal women
296266|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
296267|NCT01256944|O1|Outcome|Control|The normal women
296268|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
296269|NCT01256944|O1|Outcome|Control|The normal women
296270|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing’s syndrome)"
296271|NCT01256944|O1|Outcome|Control|The normal women
296272|NCT01256944|E2|Reported Event|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
296273|NCT01256944|E1|Reported Event|Control|The normal women
296274|NCT01256918|B1|Baseline|Patients Undergoing Phacoemulsification|Patients (> 40 years of age) with grade 3.0 to 6.9( according to LOCS-III) of senile cataract were included in this study.200 consecutive patients were enrolled and achievement of milestone noted while attempting vertical chop during phacoemulsification using a calibrated phacotip.
296275|NCT01256918|P1|Participant Flow|Patients Undergoing Phacoemulsification|Patients (> 40 years of age) with grade 3.0 to 6.9( according to LOCS-III) of senile cataract were included in this study.200 consecutive patients were enrolled and achievement of milestone noted while attempting vertical chop during phacoemulsification using a calibrated phacotip.
296276|NCT01256918|O2|Outcome|Phacodepth|depth of penetration of phacotip required to achieve a full thickness crack in vertical chop during phacoemulsification
296277|NCT01256918|O1|Outcome|Lens Thickness|lens thickness as measured using an A scan biometer
296278|NCT01256918|O2|Outcome|Phacodepth|actual depth of penetration (in mm) of phacotip required to achieve a full thickness crack in vertical chop during phacoemulsification
296279|NCT01256918|O1|Outcome|Nuclear Opalescence|nuclear grading as per LOCS III criteria for cataract.nuclear opalescence is graded on a scale from 0.1 to 6.9 by comparing with standard photographs of cataract, under lens opacities classification system III, on a Haag Streit slit lamp under standard conditions of illumination
296280|NCT01256918|O2|Outcome|Phacodepth|actual depth of penetration(in mm) of phacotip required to achieve a full thickness crack in vertical chop during phacoemulsification
296281|NCT01256918|O1|Outcome|Nuclear Colour|nuclear grading as per LOCS III criteria for cataract shall be done on a decimal scale from 0.1 to 6.9 nuclear colour is graded on a scale from 0.1 to 6.9 by comparing with standard photographs of cataract, under lens opacities classification system III, on a Haag Streit slit lamp under standard conditions of illumination
296282|NCT01256918|O1|Outcome|Posterior Capsular Rupture|A note shall be made of any posterior capsular rupture attributable to the attempted vertical chop during the phacoemulsification procedure.
296283|NCT01256918|O1|Outcome|Phacodepth|A note shall be made of the phacodepth at which a complete vertical chop is achieved during the attempted vertical chop .
296284|NCT01256918|E1|Reported Event|Patients Undergoing Phacoemulsification|Patients (> 40 years of age) with grade 3.0 to 6.9( according to LOCS-III) of senile cataract were included in this study.200 consecutive patients were enrolled and achievement of milestone noted while attempting vertical chop during phacoemulsification using a calibrated phacotip.
296285|NCT01256840|B4|Baseline|Total|Total of all reporting groups
296314|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
296566|NCT01256190|P2|Participant Flow|Gelatin Sponge|approved device for surgical bleeding
296286|NCT01256840|B3|Baseline|Obese Comparison Group|We recruited the comparison groups to match the CR group in age, race/ethnicity, gender, and educational attainment. Additionally, we recruited siblings of CR participants to attempt to control for genetic and environmental factors. All participants were non-smokers, and all were not pregnant.
296287|NCT01256840|B2|Baseline|Normal-eating Controls|We recruited the comparison groups to match the CR group in age, race/ethnicity, gender, and educational attainment. Additionally, we recruited siblings of CR participants to attempt to control for genetic and environmental factors. All participants were non-smokers, and all were not pregnant.
296288|NCT01256840|B1|Baseline|Calorie Restricting Group|Inclusion criteria for the CR group were reporting calorie restriction without malnutrition for a minimum of two years and BMI < 24.99. Whenever possible, the President of the CR Way Longevity Center and Vice President for Research of the CR Society International or the Chairman of the Board of The CR Society International and Treasurer and Vice President of the CR Way Longevity Center confirmed each participant’s self-reported duration of and adherence to calorie restriction. Calorie restriction was also verified via four weekly random fasting glucose tests (<80 mg/dL) with Bayer glucometers. Nursing staff verified BMI on-site.
296289|NCT01256840|P3|Participant Flow|Obese Comparison Group|We recruited the comparison groups to match the CR group in age, race/ethnicity, gender, and educational attainment. Additionally, we recruited siblings of CR participants to attempt to control for genetic and environmental factors. All participants were non-smokers, and all were not pregnant.
296290|NCT01256840|P2|Participant Flow|Normal-eating Controls|We recruited the comparison groups to match the CR group in age, race/ethnicity, gender, and educational attainment. Additionally, we recruited siblings of CR participants to attempt to control for genetic and environmental factors. All participants were non-smokers, and all were not pregnant.
296291|NCT01256840|P1|Participant Flow|Calorie Restricting Group|Inclusion criteria for the CR group were reporting calorie restriction without malnutrition for a minimum of two years and BMI < 24.99. Whenever possible, the President of the CR Way Longevity Center and Vice President for Research of the CR Society International or the Chairman of the Board of The CR Society International and Treasurer and Vice President of the CR Way Longevity Center confirmed each participant’s self-reported duration of and adherence to calorie restriction. Calorie restriction was also verified via four weekly random fasting glucose tests (<80 mg/dL) with Bayer glucometers. Nursing staff verified BMI on-site.
296292|NCT01256840|O3|Outcome|Obese Comparison Group|We recruited the comparison groups to match the CR group in age, race/ethnicity, gender, and educational attainment. Additionally, we recruited siblings of CR participants to attempt to control for genetic and environmental factors. All participants were non-smokers, and all were not pregnant.
296293|NCT01256840|O2|Outcome|Normal-eating Controls|We recruited the comparison groups to match the CR group in age, race/ethnicity, gender, and educational attainment. Additionally, we recruited siblings of CR participants to attempt to control for genetic and environmental factors. All participants were non-smokers, and all were not pregnant.
296294|NCT01256840|O1|Outcome|Calorie Restricting Group|Inclusion criteria for the CR group were reporting calorie restriction without malnutrition for a minimum of two years and BMI < 24.99. Whenever possible, the President of the CR Way Longevity Center and Vice President for Research of the CR Society International or the Chairman of the Board of The CR Society International and Treasurer and Vice President of the CR Way Longevity Center confirmed each participant’s self-reported duration of and adherence to calorie restriction. Calorie restriction was also verified via four weekly random fasting glucose tests (<80 mg/dL) with Bayer glucometers. Nursing staff verified BMI on-site.
296295|NCT01256840|E3|Reported Event|Obese Comparison Group|We recruited the comparison groups to match the CR group in age, race/ethnicity, gender, and educational attainment. Additionally, we recruited siblings of CR participants to attempt to control for genetic and environmental factors. All participants were non-smokers, and all were not pregnant.
296296|NCT01256840|E2|Reported Event|Normal-eating Controls|We recruited the comparison groups to match the CR group in age, race/ethnicity, gender, and educational attainment. Additionally, we recruited siblings of CR participants to attempt to control for genetic and environmental factors. All participants were non-smokers, and all were not pregnant.
296297|NCT01256840|E1|Reported Event|Calorie Restricting Group|Inclusion criteria for the CR group were reporting calorie restriction without malnutrition for a minimum of two years and BMI < 24.99. Whenever possible, the President of the CR Way Longevity Center and Vice President for Research of the CR Society International or the Chairman of the Board of The CR Society International and Treasurer and Vice President of the CR Way Longevity Center confirmed each participant's self-reported duration of and adherence to calorie restriction. Calorie restriction was also verified via four weekly random fasting glucose tests (<80 mg/dL) with Bayer glucometers. Nursing staff verified BMI on-site.
296298|NCT01256684|B4|Baseline|Total|Total of all reporting groups
296299|NCT01256684|B3|Baseline|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
296300|NCT01256684|B2|Baseline|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
296301|NCT01256684|B1|Baseline|Placebo|Placebo: Placebo vaginal suppository
296302|NCT01256684|P3|Participant Flow|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
296303|NCT01256684|P2|Participant Flow|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
296304|NCT01256684|P1|Participant Flow|Placebo|Placebo: Placebo vaginal suppository
296305|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
296306|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
296307|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
296308|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
296309|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
296310|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
296311|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
296315|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
296316|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
296317|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
296318|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
296319|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
296320|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
296321|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
296322|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
296323|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
296324|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
296325|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
296326|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
296327|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
296328|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
296329|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
296330|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
296331|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
296332|NCT01256684|E3|Reported Event|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
296333|NCT01256684|E2|Reported Event|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
296334|NCT01256684|E1|Reported Event|Placebo|Placebo: Placebo vaginal suppository
296335|NCT01256671|B1|Baseline|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
296336|NCT01256671|P1|Participant Flow|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
296337|NCT01256671|O1|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
296338|NCT01256671|O1|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
296339|NCT01256671|O1|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
296340|NCT01256671|O1|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
296341|NCT01256671|O1|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
296342|NCT01256671|O1|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
296343|NCT01256671|O1|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
296344|NCT01256671|O1|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
296345|NCT01256671|E1|Reported Event|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
296346|NCT01256658|B3|Baseline|Total|Total of all reporting groups
296347|NCT01256658|B2|Baseline|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
296348|NCT01256658|B1|Baseline|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
296349|NCT01256658|P2|Participant Flow|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
296350|NCT01256658|P1|Participant Flow|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
296351|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
296352|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
296353|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
296354|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
296355|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
296356|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
296357|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
296358|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
296359|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
296360|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
296361|NCT01256658|O2|Outcome|Control|Not applicable to this outcome measure
296362|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
296363|NCT01256658|O2|Outcome|Control|Not applicable to this outcome measure
296364|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
296366|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
296367|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
296368|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
296369|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
296370|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
296371|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
296372|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
296373|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
296374|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
296375|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
296376|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
296377|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
296378|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
296379|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
296380|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
296381|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
296382|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
296383|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
296384|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
296385|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
296386|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
296387|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
296388|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
296389|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
296390|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
296391|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
296392|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
296393|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
296394|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
296395|NCT01256658|E4|Reported Event|Control - Period 2- Follow-up Only|Participants from the control group of period 1 were followed up to assess longer term impact of initial intervention on malaria episodes. No treatment was given to participants during period 2.
296396|NCT01256658|E3|Reported Event|Intervention - Period 2 - Follow-up Only|Participants from the intervention group of period 1 were followed up to assess longer term impact of initial intervention on malaria episodes. No treatment was given to participants during period 2.
296397|NCT01256658|E2|Reported Event|Control - Period 1|Participants received COA566 treatment for symptomatic malaria episodes only.
296398|NCT01256658|E1|Reported Event|Intervention - Period 1|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
296399|NCT01256567|B1|Baseline|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
296400|NCT01256567|P1|Participant Flow|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab (IMC-1121B) administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
296401|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
296402|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel : Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab : Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
296403|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
296404|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
298660|NCT01251315|B6|Baseline|Proimmune 200-B|Proimmune 200 High dose group (6000mg oral x1)
296405|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
296406|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
296407|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
296408|NCT01256567|E1|Reported Event|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
296409|NCT01256502|B1|Baseline|Implanted Participants|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
296410|NCT01256502|P1|Participant Flow|Implanted Participants|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
296411|NCT01256502|O1|Outcome|Implanted Participants|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
296412|NCT01256502|O5|Outcome|Very Easy to Use|
296413|NCT01256502|O4|Outcome|Easy to Use|
296414|NCT01256502|O3|Outcome|Neither Difficult Nor Easy to Use|
296415|NCT01256502|O2|Outcome|Difficult to Use|
296416|NCT01256502|O1|Outcome|Very Difficult to Use|
296417|NCT01256502|O1|Outcome|Implanted Participants|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
296418|NCT01256502|E1|Reported Event|Implanted Participants|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
296419|NCT01256476|B3|Baseline|Total|Total of all reporting groups
296420|NCT01256476|B2|Baseline|Pravastatin 40 mg Once a Day (QD)|
296421|NCT01256476|B1|Baseline|Pitavastatin 4 mg Once a Day (QD)|
296422|NCT01256476|P2|Participant Flow|Pravastatin 40 mg Once a Day (QD)|
296423|NCT01256476|P1|Participant Flow|Pitavastatin 4 mg Once a Day (QD)|
296424|NCT01256476|O2|Outcome|Pravastatin 40 mg Once Daily (QD)|
296425|NCT01256476|O1|Outcome|Pitavastatin 4 mg Once Daily (QD)|
296426|NCT01256476|E2|Reported Event|Pravastatin 40 mg Once a Day (QD)|
296427|NCT01256476|E1|Reported Event|Pitavastatin 4 mg Once a Day (QD)|
296428|NCT01256450|B3|Baseline|Total|Total of all reporting groups
296429|NCT01256450|B2|Baseline|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
296430|NCT01256450|B1|Baseline|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
296431|NCT01256450|P3|Participant Flow|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
296432|NCT01256450|P2|Participant Flow|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
296433|NCT01256450|P1|Participant Flow|OL Buprenorphine HCl Buccal Film|Buprenorphine hydrochloride (HCl) buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for up to 4 weeks in the open-label titration period
296434|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
296435|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
296436|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
296437|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
296438|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
296439|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
296440|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
296441|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
296442|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
296443|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
296444|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
296445|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
296446|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
296447|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
296448|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
296449|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
296450|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
296451|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
296452|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
296453|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
296454|NCT01256450|E3|Reported Event|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind period
296455|NCT01256450|E2|Reported Event|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind period
296456|NCT01256450|E1|Reported Event|OL Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for up to 4 weeks in the open-label titration period
296457|NCT01256424|B5|Baseline|Total|Total of all reporting groups
296458|NCT01256424|B4|Baseline|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment, no photoactivation
296459|NCT01256424|B3|Baseline|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
296460|NCT01256424|B2|Baseline|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
296461|NCT01256424|B1|Baseline|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
296462|NCT01256424|P4|Participant Flow|Placebo Ointment Without Illumination|Treatment with a singe dose of 2g placebo ointment, no photoactivation
296463|NCT01256424|P3|Participant Flow|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
296464|NCT01256424|P2|Participant Flow|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
296465|NCT01256424|P1|Participant Flow|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
296466|NCT01256424|O4|Outcome|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment,no photoactivation
296467|NCT01256424|O3|Outcome|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
296468|NCT01256424|O2|Outcome|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
296469|NCT01256424|O1|Outcome|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
296470|NCT01256424|O4|Outcome|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment,no photoactivation
296471|NCT01256424|O3|Outcome|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
296472|NCT01256424|O2|Outcome|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
296473|NCT01256424|O1|Outcome|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
296474|NCT01256424|O4|Outcome|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment,no photoactivation
296475|NCT01256424|O3|Outcome|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
296476|NCT01256424|O2|Outcome|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
296477|NCT01256424|O1|Outcome|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
296478|NCT01256424|O4|Outcome|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment, no photoactivation
296479|NCT01256424|O3|Outcome|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
296480|NCT01256424|O2|Outcome|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
296481|NCT01256424|O1|Outcome|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
296482|NCT01256424|E4|Reported Event|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment, no photoactivation
296483|NCT01256424|E3|Reported Event|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
296484|NCT01256424|E2|Reported Event|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
296485|NCT01256424|E1|Reported Event|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
296486|NCT01256411|B5|Baseline|Total|Total of all reporting groups
296487|NCT01256411|B4|Baseline|LCZ696 400 mg/Amlodipine/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
296488|NCT01256411|B3|Baseline|LCZ606 400 mg/Amlodipine|Participants received LCZ696 400 mg by mouth qd and amlodipine 5mg up to 10 mg by mouth as needed (prn).
296491|NCT01256411|P6|Participant Flow|LCZ696 Combination Therapy|Participants received LCZ696 with amlodipine and/or HCTZ.
296492|NCT01256411|P5|Participant Flow|LCZ696 Monotherapy|Participants received LCZ696 only.
296493|NCT01256411|P4|Participant Flow|LCZ696 400 mg/Amlodipine/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
296494|NCT01256411|P3|Participant Flow|LCZ606 400 mg/Amlodipine|Participants received LCZ696 400 mg by mouth qd and amlodipine 5mg up to 10 mg by mouth as needed (prn).
296495|NCT01256411|P2|Participant Flow|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
296496|NCT01256411|P1|Participant Flow|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
296497|NCT01256411|O2|Outcome|LCZ696 Combination Therapy|Participants received LCZ696 with amlodipine and/or HCTZ.
296498|NCT01256411|O1|Outcome|LCZ696 Monotherapy|Participants received LCZ696 only.
296499|NCT01256411|O4|Outcome|LCZ696 400 mg/Amlodipine/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
296500|NCT01256411|O3|Outcome|LCZ606 400 mg/Amlodipine|Participants received LCZ696 400 mg by mouth qd and amlodipine 5mg up to 10 mg by mouth as needed (prn).
296501|NCT01256411|O2|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
296502|NCT01256411|O1|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
296503|NCT01256411|O2|Outcome|LCZ696 Combination Therapy|Participants received LCZ696 with amlodipine and/or HCTZ.
296504|NCT01256411|O1|Outcome|LCZ696 Monotherapy|Participants received LCZ696 only.
296505|NCT01256411|O4|Outcome|LCZ696 400 mg/Amlodipine/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
296506|NCT01256411|O3|Outcome|LCZ606 400 mg/Amlodipine|Participants received LCZ696 400 mg by mouth qd and amlodipine 5mg up to 10 mg by mouth as needed (prn).
296507|NCT01256411|O2|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
296508|NCT01256411|O1|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
296509|NCT01256411|O5|Outcome|LCZ696 100 mg|Participants were down-titrated to 100 mg.
296510|NCT01256411|O4|Outcome|LCZ696 400 mg/Amlodipine/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
296511|NCT01256411|O3|Outcome|LCZ606 400 mg/Amlodipine|Participants received LCZ696 400 mg by mouth qd and amlodipine 5mg up to 10 mg by mouth as needed (prn).
296512|NCT01256411|O2|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
296513|NCT01256411|O1|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
296514|NCT01256411|E5|Reported Event|LCZ696 400 mg/Aml/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
296515|NCT01256411|E4|Reported Event|LCZ696 400 mg/Aml|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
296516|NCT01256411|E3|Reported Event|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
296517|NCT01256411|E2|Reported Event|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
296518|NCT01256411|E1|Reported Event|LCZ696 100 mg|Participants were down-titrated to 100 mg.
296519|NCT01256385|B3|Baseline|Total|Total of all reporting groups
296520|NCT01256385|B2|Baseline|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
296521|NCT01256385|B1|Baseline|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
296522|NCT01256385|P2|Participant Flow|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
296523|NCT01256385|P1|Participant Flow|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
296524|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
296525|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
296526|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
296527|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
296528|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
296529|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
296530|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
296531|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
296565|NCT01256190|B1|Baseline|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
296532|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
296533|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
296534|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
296535|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
296536|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
296537|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
296538|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
296539|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
296540|NCT01256385|E2|Reported Event|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
296541|NCT01256385|E1|Reported Event|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
296542|NCT01256294|B1|Baseline|All Participants|"Period 1 (Days 1 through 14): Participants randomized to Sequence 1 took branded tacrolimus (Prograf) and participants randomized to Sequence 2 took generic tacrolimus (Sandoz).~Period 2 (Days 15 through 28): Participants randomized to Sequence 1 crossed over to treatment with generic tacrolimus and participants randomized to Sequence 2 crossed over to treatment with branded tacrolimus."
296543|NCT01256294|P2|Participant Flow|Sequence 2 - Generic Tacrolimus / Branded Tacrolimus|In Period 1 (Days 1-14) participants received generic tacrolimus (Sandoz) orally twice a day and in Period 2 (Days 15-28) participants received branded tacrolimus (Prograf) orally twice a day. Participants received the same stable dosage of tacrolimus dose they had been taking prior to enrollment (on a milligram for milligram basis).
296544|NCT01256294|P1|Participant Flow|Sequence 1 - Branded Tacrolimus / Generic Tacrolimus|In Period 1 (Days 1 - 14) participants received branded tacrolimus (Prograf) orally twice a day and in Period 2 (Days 15 - 28) participants received generic tacrolimus (Sandoz) orally twice a day. Participants received the same stable dosage of tacrolimus they had been taking prior to enrollment (on a milligram for milligram basis).
296545|NCT01256294|O2|Outcome|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
296546|NCT01256294|O1|Outcome|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
296547|NCT01256294|O2|Outcome|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
296548|NCT01256294|O1|Outcome|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
296549|NCT01256294|O2|Outcome|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
296550|NCT01256294|O1|Outcome|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
296551|NCT01256294|O2|Outcome|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
296552|NCT01256294|O1|Outcome|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
296553|NCT01256294|O2|Outcome|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
296554|NCT01256294|O1|Outcome|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
296555|NCT01256294|O2|Outcome|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
296556|NCT01256294|O1|Outcome|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
296557|NCT01256294|E2|Reported Event|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
296558|NCT01256294|E1|Reported Event|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
296559|NCT01256281|B1|Baseline|Femoral Nerve Block|Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
296560|NCT01256281|P1|Participant Flow|Femoral Nerve Block|Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
296561|NCT01256281|O1|Outcome|Femoral Nerve Block|Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
296562|NCT01256281|E1|Reported Event|Femoral Nerve Block|Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
296563|NCT01256190|B3|Baseline|Total|Total of all reporting groups
296567|NCT01256190|P1|Participant Flow|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
296568|NCT01256190|O2|Outcome|Gelatin Sponge|approved device for surgical bleeding
296569|NCT01256190|O1|Outcome|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
296570|NCT01256190|O2|Outcome|Gelatin Sponge|approved device for surgical bleeding
296571|NCT01256190|O1|Outcome|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
296572|NCT01256190|O2|Outcome|Gelatin Sponge|approved device for surgical bleeding
296573|NCT01256190|O1|Outcome|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
296574|NCT01256190|O2|Outcome|Gelatin Sponge|approved device for surgical bleeding
296575|NCT01256190|O1|Outcome|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
296576|NCT01256190|O2|Outcome|Gelatin Sponge|approved device for surgical bleeding
296577|NCT01256190|O1|Outcome|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
296578|NCT01256190|E2|Reported Event|Gelatin Sponge|approved device for surgical bleeding
296579|NCT01256190|E1|Reported Event|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
296580|NCT01256177|B3|Baseline|Total|Total of all reporting groups
296581|NCT01256177|B2|Baseline|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
296582|NCT01256177|B1|Baseline|Placebo|Placebo matching Quetiapine XR.
296583|NCT01256177|P2|Participant Flow|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
296584|NCT01256177|P1|Participant Flow|Placebo|Placebo matching Quetiapine XR.
296585|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
296586|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
296587|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
296588|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
296589|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
296590|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
296591|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
296592|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
296593|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
296594|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
296595|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
296596|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
296597|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
296598|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
296599|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
296600|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
296601|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
296602|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
296603|NCT01256177|E2|Reported Event|QUETIAPINE XR|
296604|NCT01256177|E1|Reported Event|PLACEBO|
296605|NCT01256164|B3|Baseline|Total|Total of all reporting groups
296606|NCT01256164|B2|Baseline|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
296607|NCT01256164|B1|Baseline|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
296608|NCT01256164|P2|Participant Flow|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
296609|NCT01256164|P1|Participant Flow|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
296610|NCT01256164|O2|Outcome|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
296611|NCT01256164|O1|Outcome|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
296612|NCT01256164|O2|Outcome|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
296613|NCT01256164|O1|Outcome|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
296614|NCT01256164|O2|Outcome|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
296615|NCT01256164|O1|Outcome|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
296616|NCT01256164|O2|Outcome|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
296617|NCT01256164|O1|Outcome|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
296618|NCT01256164|O2|Outcome|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
296619|NCT01256164|O1|Outcome|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
296620|NCT01256164|E2|Reported Event|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
296621|NCT01256164|E1|Reported Event|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
296622|NCT01256086|B5|Baseline|Total|Total of all reporting groups
296623|NCT01256086|B4|Baseline|A2N2N1A1|Sequence 4: A2N2N1A1 (Treatment day 1 to treatment day 4) N1 = 12µg Novolizer N2 = 24µg Novolizer A1 = 12µg Aerolizer A2 = 24µg Aerolizer
296624|NCT01256086|B3|Baseline|N2A1A2N1|Sequence 3: N2A1A2N1 (Treatment day 1 to treatment day 4) N1 = 12µg Novolizer N2 = 24µg Novolizer A1 = 12µg Aerolizer A2 = 24µg Aerolizer
296625|NCT01256086|B2|Baseline|A1N1N2A2|Sequence 2: A1N1N2A2 (Treatment day 1 to treatment day 4) N1 = 12µg Novolizer N2 = 24µg Novolizer A1 = 12µg Aerolizer A2 = 24µg Aerolizer
296626|NCT01256086|B1|Baseline|N1A2A1N2|Sequence 1: N1A2A1N2 (Treatment day 1 to treatment day 4) N1 = 12µg Novolizer N2 = 24µg Novolizer A1 = 12µg Aerolizer A2 = 24µg Aerolizer
296627|NCT01256086|P4|Participant Flow|A2N2N1A1|Treatment sequence 24 µg Aerolizer - 24 µg Novolizer - 12 µg Novolizer - 12 µg Aerolizer
296628|NCT01256086|P3|Participant Flow|N2A1A2N1|Treatment sequence 24 µg Novolizer - 12 µg Aerolizer - 24 µg Aerolizer - 12 µg Novolizer
296629|NCT01256086|P2|Participant Flow|A1N1N2A2|Treatment sequence 12 µg Aerolizer - 12 µg Novolizer - 24 µg Novolizer - 24 µg Aerolizer
296630|NCT01256086|P1|Participant Flow|N1A2A1N2|Treatment sequence 12 µg Novolizer - 24 µg Aerolizer - 12 µg Aerolizer - 24 µg Novolizer
296631|NCT01256086|O4|Outcome|12µg Formoterol Aerolizer|Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2
296632|NCT01256086|O3|Outcome|24 µg Formoterol Aerolizer|Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2
296633|NCT01256086|O2|Outcome|12µg Formoterol Novolizer|12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
296634|NCT01256086|O1|Outcome|24 µg Formoterol Novolizer|12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
296635|NCT01256086|E4|Reported Event|12µg Formoterol Aerolizer|Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2
296636|NCT01256086|E3|Reported Event|24 µg Formoterol Aerolizer|Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2
296637|NCT01256086|E2|Reported Event|12µg Formoterol Novolizer|12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
296638|NCT01256086|E1|Reported Event|24 µg Formoterol Novolizer|12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
296639|NCT01256060|B1|Baseline|Intanasal Oxytocin|"A modified dose finding method was used to determine safety among four dose levels. Half the dose (0.2 IU/kg /dose) was the minimum dose and two intermediate doses were also evaluated (0.26 and 0.33 IU/kg / dose) Dose-finding escalations were done in groups of three patients.~Three patients were studied at the first dose level~If none of these patients experienced dose limiting toxicity, the dose was escalated.~If one patient experienced dose limiting toxicity, up to three more patients were accrued at the same level. (a) If none of these patients experienced dose limiting toxicity, the dose was escalated. (b) If one or more experienced dose-limiting toxicity, entry at that dose level would be stopped, the maximum tolerated dose exceeded, and dose escalation would be stopped. Up to three more patients would be treated at the next lower dose. If zero out of three patients experience dose limiting toxicity, an additional three patients were to be treated at that dose."
296640|NCT01256060|P4|Participant Flow|0.4 IU / kg|
296641|NCT01256060|P3|Participant Flow|0.33 IU / kg|
296642|NCT01256060|P2|Participant Flow|0.26 IU / kg|
296643|NCT01256060|P1|Participant Flow|0.2 IU / kg|
296644|NCT01256060|O1|Outcome|Intranasal Oxytocin|Oxytocin: Intranasal Oxytocin
296645|NCT01256060|O1|Outcome|Intranasal Oxytocin|Oxytocin: Intranasal Oxytocin
296646|NCT01256060|O1|Outcome|Intanasal Oxytocin|Number of Participants Experiencing a Serious Adverse Event
296647|NCT01256060|O1|Outcome|Intanasal Oxytocin|Cohort 1 Dosage: 0.20 IU/kg - 3 participants Cohort 2 Dosage: 0.26 IU/kg - 3 participants Cohort 3 Dosage: 0.33 IU/kg - 3 participants Cohort 4 Dosage: 0.40 IU/kg - 6 participants
296648|NCT01256060|E1|Reported Event|Intranasal Oxytocin|Oxytocin: Intranasal Oxytocin. Please note that the Adverse Events are not presented per dose level received, as this is not a dose-finding study, it is a modified maximum tolerated dose study. This means that a small number of participants were exposed to increasing dose levels to assess for Adverse Events. It is not meaningful to analyze adverse events by cohorts due to the extremely small sample size.
296649|NCT01256034|B3|Baseline|Total|Total of all reporting groups
296650|NCT01256034|B2|Baseline|Group B|ordinary diet
296651|NCT01256034|B1|Baseline|Group A|preoperative immunonutrition
296652|NCT01256034|P2|Participant Flow|Group B|ordinary diet
296653|NCT01256034|P1|Participant Flow|Group A|preoperative immunonutrition
296654|NCT01256034|O2|Outcome|Group B|ordinary diet
296655|NCT01256034|O1|Outcome|Group A|preoperative immunonutrition
296656|NCT01256034|E2|Reported Event|Group B|ordinary diet
296657|NCT01256034|E1|Reported Event|Group A|preoperative immunonutrition
296658|NCT01256008|B4|Baseline|Total|Total of all reporting groups
296659|NCT01256008|B3|Baseline|stage1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
296660|NCT01256008|B2|Baseline|stage1 CBT|"The experimental group each session.~CBT: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
296661|NCT01256008|B1|Baseline|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
296662|NCT01256008|P3|Participant Flow|Stage 1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
296663|NCT01256008|P2|Participant Flow|Stage 1 CBT|"The experimental group will receive CBT each session.~CBT: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
296664|NCT01256008|P1|Participant Flow|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
296665|NCT01256008|O3|Outcome|stage1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
296666|NCT01256008|O2|Outcome|stage1 CBT|"The experimental group will receive CBT each session.~CBT: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
296667|NCT01256008|O1|Outcome|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
296668|NCT01256008|O3|Outcome|stage1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
296669|NCT01256008|O2|Outcome|stage1 CBT|"The experimental group will receive CBT each session.~CBT: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
296670|NCT01256008|O1|Outcome|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
296671|NCT01256008|O3|Outcome|Stage 1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
296672|NCT01256008|O2|Outcome|Stage 1 CBT|"The experimental group will receive CBT each session.~CBT and clinical management: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
296673|NCT01256008|O1|Outcome|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
296674|NCT01256008|O3|Outcome|stage1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
296675|NCT01256008|O2|Outcome|stage1 CBT|"The experimental group will receive CBT each session.~CBT: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
296676|NCT01256008|O1|Outcome|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
296677|NCT01256008|O3|Outcome|Stage 1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
296678|NCT01256008|O2|Outcome|Stage 1 CBT|"The experimental group will receive CBT each session.~CBT and clinical management: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
296679|NCT01256008|O1|Outcome|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
296680|NCT01256008|E3|Reported Event|stage1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
296681|NCT01256008|E2|Reported Event|stage1 CBT|"The experimental group will receive CBT each session.~CBT and clinical management: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
296719|NCT01255787|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
296720|NCT01255787|O1|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
296682|NCT01256008|E1|Reported Event|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
296683|NCT01255904|B3|Baseline|Total|Total of all reporting groups
296684|NCT01255904|B2|Baseline|Oral Chloral Hydrate and Intranasal Placebo|
296685|NCT01255904|B1|Baseline|Oral Placebo and Intransal Dexmedetomidine|
296686|NCT01255904|P2|Participant Flow|Oral Chloral Hydrate and Intranasal Placebo|50 mg/kg oral chloral hydrate followed by intranasal placebo.
296687|NCT01255904|P1|Participant Flow|Oral Placebo and Intransal Dexmedetomidine|Oral placebo followed by Intranasal dexmedetomidine 3 mcg/kg (max dose 100 mcg).
296688|NCT01255904|O2|Outcome|Oral Chloral Hydrate and Intranasal Placebo|
296689|NCT01255904|O1|Outcome|Oral Placebo and Intransal Dexmedetomidine|
296690|NCT01255904|E2|Reported Event|Oral Chloral Hydrate and Intranasal Placebo|
296691|NCT01255904|E1|Reported Event|Oral Placebo and Intransal Dexmedetomidine|
296692|NCT01255787|B5|Baseline|Total|Total of all reporting groups
296693|NCT01255787|B4|Baseline|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
296694|NCT01255787|B3|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
296695|NCT01255787|B2|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
296696|NCT01255787|B1|Baseline|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
296697|NCT01255787|P4|Participant Flow|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
296698|NCT01255787|P3|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
296699|NCT01255787|P2|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
296700|NCT01255787|P1|Participant Flow|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
296701|NCT01255787|O4|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
296702|NCT01255787|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
296703|NCT01255787|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
296704|NCT01255787|O1|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
296705|NCT01255787|O4|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
296706|NCT01255787|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
296707|NCT01255787|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
296708|NCT01255787|O1|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
296709|NCT01255787|O4|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
296710|NCT01255787|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
296711|NCT01255787|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
296712|NCT01255787|O1|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
296713|NCT01255787|O4|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
296714|NCT01255787|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
296715|NCT01255787|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
296716|NCT01255787|O1|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
296717|NCT01255787|O4|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
296718|NCT01255787|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
296721|NCT01255787|E4|Reported Event|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
296722|NCT01255787|E3|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
296723|NCT01255787|E2|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
296724|NCT01255787|E1|Reported Event|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
296725|NCT01255761|B3|Baseline|Total|Total of all reporting groups
296726|NCT01255761|B2|Baseline|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296727|NCT01255761|B1|Baseline|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296728|NCT01255761|P2|Participant Flow|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296729|NCT01255761|P1|Participant Flow|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296730|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296731|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296732|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296733|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296734|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296735|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296736|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296737|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296738|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296739|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296740|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296741|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296742|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296743|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296744|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296745|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296746|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296747|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296748|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296749|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296750|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296751|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296752|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296753|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296754|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296755|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296756|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296757|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296758|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296759|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296760|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296761|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296762|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296763|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296764|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296765|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296766|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296767|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296768|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296769|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296770|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296771|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296772|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296773|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296774|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296775|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296776|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296777|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296778|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296779|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296780|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296781|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296782|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296783|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296784|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296785|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296786|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296787|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296788|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296789|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296790|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296791|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296792|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296793|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296794|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296795|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296796|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296797|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296798|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296799|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296800|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296801|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296802|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296803|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296804|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296805|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296806|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296807|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296808|NCT01255761|E2|Reported Event|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
296809|NCT01255761|E1|Reported Event|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
296810|NCT01255722|B4|Baseline|Total|Total of all reporting groups
296811|NCT01255722|B3|Baseline|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
296812|NCT01255722|B2|Baseline|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
296813|NCT01255722|B1|Baseline|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
296814|NCT01255722|P3|Participant Flow|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
296815|NCT01255722|P2|Participant Flow|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
296816|NCT01255722|P1|Participant Flow|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
296817|NCT01255722|O3|Outcome|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
296818|NCT01255722|O2|Outcome|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
296819|NCT01255722|O1|Outcome|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
296820|NCT01255722|O3|Outcome|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
296821|NCT01255722|O2|Outcome|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
296822|NCT01255722|O1|Outcome|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
296823|NCT01255722|O3|Outcome|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
296824|NCT01255722|O2|Outcome|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
296825|NCT01255722|O1|Outcome|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
296826|NCT01255722|O3|Outcome|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
296827|NCT01255722|O2|Outcome|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
296828|NCT01255722|O1|Outcome|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
296829|NCT01255722|O3|Outcome|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
296830|NCT01255722|O2|Outcome|Iopromide|Patients were IV injected with a single dose of iopromide before coronary CT angiography
296831|NCT01255722|O1|Outcome|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
296832|NCT01255722|O3|Outcome|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
296833|NCT01255722|O2|Outcome|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
296834|NCT01255722|O1|Outcome|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
296835|NCT01255722|E3|Reported Event|Iomeprol|"Patients were IV injected with a single dose of iomeprol before a coronary CT angiography~iomeprol: Single IV injection"
296836|NCT01255722|E2|Reported Event|Iopromide|"Patients were IV injected with a single dose of iopromide before a coronary CT angiography~iopromide: Single IV injection"
296837|NCT01255722|E1|Reported Event|Iobitridol|"Patients were IV injected with a single dose of iobitridol before a coronary CT angiography~iobitridol: single IV injection"
296838|NCT01255631|B3|Baseline|Total|Total of all reporting groups
296839|NCT01255631|B2|Baseline|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
296840|NCT01255631|B1|Baseline|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
296841|NCT01255631|P2|Participant Flow|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
296842|NCT01255631|P1|Participant Flow|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
296843|NCT01255631|O2|Outcome|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
296844|NCT01255631|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
296845|NCT01255631|O2|Outcome|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
296846|NCT01255631|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
296847|NCT01255631|O2|Outcome|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
296848|NCT01255631|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
296849|NCT01255631|O2|Outcome|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
296850|NCT01255631|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
296851|NCT01255631|O2|Outcome|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
296852|NCT01255631|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
296853|NCT01255631|O2|Outcome|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
296854|NCT01255631|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
296926|NCT01255436|O2|Outcome|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
296927|NCT01255436|O1|Outcome|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
296855|NCT01255631|E2|Reported Event|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
296856|NCT01255631|E1|Reported Event|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
296857|NCT01255592|B3|Baseline|Total|Total of all reporting groups
296858|NCT01255592|B2|Baseline|Placebo|Placebo bd
296859|NCT01255592|B1|Baseline|AZD5069|AZD5069 80 mg bd
296860|NCT01255592|P2|Participant Flow|Placebo|Placebo for AZD5069, bd
296861|NCT01255592|P1|Participant Flow|AZD5069|AZD5069 80 mg bd
296862|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
296863|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
296864|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
296865|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
296866|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
296867|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
296868|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
296869|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
296870|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
296871|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
296872|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
296873|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
296874|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
296875|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
296876|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
296877|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
296878|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
296879|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
296880|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
296881|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
296882|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
296883|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
296884|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
296885|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
296886|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
296887|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
296888|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
296889|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
296890|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
296891|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
296892|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
296893|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
296894|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
296895|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
296896|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
296897|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
296898|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
296899|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
296900|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
296901|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
296902|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
296903|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
296904|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
296905|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
296906|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
296907|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
296908|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
296909|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
296910|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
296911|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
296912|NCT01255592|O2|Outcome|Placebo|Placebo bd
296913|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
296914|NCT01255592|E2|Reported Event|Placebo|Placebo for AZD5069 bd
296915|NCT01255592|E1|Reported Event|AZD5069|80 mg bd
296916|NCT01255449|B1|Baseline|Albuterol|All recruited subjects underwent an acute bronchodilation with albuterol following baseline pulmonary function measurements.
296917|NCT01255449|P1|Participant Flow|Albuterol|On each study day, all lung function measurements were taken before and 30 min after inhaling four consecutive albuterol doses of 100 mcg each, through a valved-holding chamber. Lung diffusing capacity for carbon monoxide was measured only after bronchodilator inhalation.
296918|NCT01255449|O1|Outcome|Post-HSCT Changes in Lung Tissue Density|In eight out of 26 patients, a quantitative CT scan analysis was conducted to measure changes in lung tissue density
296919|NCT01255449|O1|Outcome|Airway Distensibility With Lung Inflation After HSCT|Changes in airway conductance at 5 Hz (Grs5) were related to changes in lung volume (DeltaGrs5/DeltaVL) to estimate airway distensibility
296920|NCT01255449|E1|Reported Event|Albuterol|All subjects underwent an acute bronchodilation with albuterol by inhaling four consecutive doses (100 mcg each)of the drug through a valved-holding chamber
296921|NCT01255436|B3|Baseline|Total|Total of all reporting groups
296922|NCT01255436|B2|Baseline|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
296923|NCT01255436|B1|Baseline|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
296924|NCT01255436|P2|Participant Flow|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
296925|NCT01255436|P1|Participant Flow|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
296928|NCT01255436|O2|Outcome|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
296929|NCT01255436|O1|Outcome|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
296930|NCT01255436|O2|Outcome|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
296931|NCT01255436|O1|Outcome|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
296932|NCT01255436|O2|Outcome|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
296933|NCT01255436|O1|Outcome|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
296934|NCT01255436|E2|Reported Event|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
296935|NCT01255436|E1|Reported Event|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
296936|NCT01255423|B3|Baseline|Total|Total of all reporting groups
296937|NCT01255423|B2|Baseline|Placebo|
296938|NCT01255423|B1|Baseline|Diclofenac Sodium Topical Gel 1%|
296939|NCT01255423|P2|Participant Flow|Placebo|
296940|NCT01255423|P1|Participant Flow|Diclofenac Sodium Topical Gel 1%|
296941|NCT01255423|O2|Outcome|Placebo|
296942|NCT01255423|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
296943|NCT01255423|O2|Outcome|Placebo|
296944|NCT01255423|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
296945|NCT01255423|O2|Outcome|Placebo|
296946|NCT01255423|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
296947|NCT01255423|O2|Outcome|Placebo|
296948|NCT01255423|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
296949|NCT01255423|O2|Outcome|Placebo|
296950|NCT01255423|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
296951|NCT01255423|E2|Reported Event|Placebo|
296952|NCT01255423|E1|Reported Event|Diclofenac Sodium Topical Gel 1%|
296953|NCT01255306|B3|Baseline|Total|Total of all reporting groups
296954|NCT01255306|B2|Baseline|RAISED IOP|Patients with raised IOP
296955|NCT01255306|B1|Baseline|NO IOP|Patients without raised IOP
296956|NCT01255306|P2|Participant Flow|RAISED IOP|Patients with raised IOP
296957|NCT01255306|P1|Participant Flow|NO IOP|Patients without raised IOP
296958|NCT01255306|O3|Outcome|CONTROL|Fellow eye of each patient
296959|NCT01255306|O2|Outcome|RAISED IOP|Patients with raised IOP
296960|NCT01255306|O1|Outcome|NO IOP|Patients without raised IOP
296961|NCT01255306|O2|Outcome|CONTROL EYES|Fellow eye of each patient
296962|NCT01255306|O1|Outcome|STUDY EYES|Study eyes that underwent pars plana vitrectomy and silicone oil tamponade
296963|NCT01255306|E2|Reported Event|CONTROL EYES|Fellow eye of each patient
296964|NCT01255306|E1|Reported Event|STUDY EYES|Study eyes that underwent pars plana vitrectomy and silicone oil tamponade
296965|NCT01255163|B3|Baseline|Total|Total of all reporting groups
296966|NCT01255163|B2|Baseline|Placebo|Placebo SC twice daily
296967|NCT01255163|B1|Baseline|Exendin-4|Exenatide 5 mcg or 10 mcg SC twice daily
296968|NCT01255163|P2|Participant Flow|Placebo|Placebo SC twice daily
296969|NCT01255163|P1|Participant Flow|Exendin-4|Exenatide 5 mcg or 10 mcg SC twice daily
296970|NCT01255163|O2|Outcome|Placebo|Placebo SC twice daily
296971|NCT01255163|O1|Outcome|Exendin-4|Exenatide 5 mcg or 10 mcg SC twice daily
296972|NCT01255163|O2|Outcome|Placebo|Placebo SC twice daily
296973|NCT01255163|O1|Outcome|Exendin-4|Exenatide 5 mcg or 10 mcg SC twice daily
296974|NCT01255163|O2|Outcome|Placebo|Placebo SC twice daily
296975|NCT01255163|O1|Outcome|Exendin-4|Exenatide 5 mcg or 10 mcg SC twice daily
296976|NCT01255163|O2|Outcome|Placebo|Placebo SC twice daily
296977|NCT01255163|O1|Outcome|Exendin-4|Exenatide 5 mcg or 10 mcg SC twice daily
296978|NCT01255163|O2|Outcome|Placebo|Placebo SC twice daily
296979|NCT01255163|O1|Outcome|Exendin-4|Exenatide 5 mcg or 10 mcg SC twice daily
296980|NCT01255163|O2|Outcome|Placebo|Placebo SC twice daily
296981|NCT01255163|O1|Outcome|Exendin-4|Exenatide 5 mcg or 10 mcg SC twice daily
296982|NCT01255163|O2|Outcome|Placebo|"Placebo SC twice daily~Placebo SC: Placebo SC twice daily"
296983|NCT01255163|O1|Outcome|Exendin-4|"Exenatide 5 mcg or 10 mcg SC twice daily~Exendin-4 SC: Exenatide 5 mcg or 10 mcg SC twice daily"
296984|NCT01255163|O2|Outcome|Placebo|Placebo SC twice daily
296985|NCT01255163|O1|Outcome|Exendin-4|Exenatide 5 mcg or 10 mcg SC twice daily
296986|NCT01255163|O2|Outcome|Placebo|Placebo SC twice daily
296987|NCT01255163|O1|Outcome|Exendin-4|Exenatide 5 mcg or 10 mcg SC twice daily
296988|NCT01255163|E2|Reported Event|Placebo|Placebo SC twice daily
296989|NCT01255163|E1|Reported Event|Exendin-4|Exenatide 5 mcg or 10 mcg SC twice daily
296990|NCT01255137|B1|Baseline|Adrenal Cortex Neoplasms|"Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.~Axitinib : 5 mg tab orally twice a day with food every 28 days"
296991|NCT01255137|P1|Participant Flow|Adrenal Cortex Neoplasms|"Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.~Axitinib : 5 mg tab orally twice a day with food every 28 days"
296992|NCT01255137|O1|Outcome|Adrenal Cortex Neoplasms|"Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.~Axitinib : 5 mg tab orally twice a day with food every 28 days"
296993|NCT01255137|O1|Outcome|Adrenal Cortex Neoplasms|"Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.~Axitinib : 5 mg tab orally twice a day with food every 28 days"
296994|NCT01255137|E1|Reported Event|Adrenal Cortex Neoplasms|"Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.~Axitinib : 5 mg tab orally twice a day with food every 28 days"
296995|NCT01254890|B3|Baseline|Total|Total of all reporting groups
296996|NCT01254890|B2|Baseline|Phase II: Azacitidine + 400 Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib 400 mg orally twice a day for 28 Day cycle.
297034|NCT01254851|B1|Baseline|Goal-augmented Post-operative Care.|Patients in this group will be given a goal number of steps to take on each post-operative day.
296997|NCT01254890|B1|Baseline|Phase I: Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
296998|NCT01254890|P2|Participant Flow|Phase II: Azacitidine + 400 mg Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib 400 mg orally twice a day for 28 Day cycle.
296999|NCT01254890|P1|Participant Flow|Phase I: Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
297000|NCT01254890|O1|Outcome|Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
297001|NCT01254890|O1|Outcome|Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
297002|NCT01254890|E2|Reported Event|Phase II: Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 400 mg orally twice a day for 28 Day cycle.
297003|NCT01254890|E1|Reported Event|Phase I: Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
297004|NCT01254877|B4|Baseline|Total|Total of all reporting groups
297005|NCT01254877|B3|Baseline|Moderate Dose Ondansetron (0.8 mg Bid)|Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
297006|NCT01254877|B2|Baseline|Low Dose Ondansetron (0.2 mg Bid)|ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks
297007|NCT01254877|B1|Baseline|Placebo Ondansetron - Sugar Pill|"Placebo is an oral preparation made to appear and taste like the active drug preparation.~placebo ondansetron: Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water."
297008|NCT01254877|P3|Participant Flow|Moderate Dose Ondansetron (0.8 mg Bid)|Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
297009|NCT01254877|P2|Participant Flow|Low Dose Ondansetron (0.2 mg Bid)|ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks
297010|NCT01254877|P1|Participant Flow|Placebo Ondansetron - Sugar Pill|"Placebo is an oral preparation made to appear and taste like the active drug preparation.~placebo ondansetron: Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water."
297011|NCT01254877|O3|Outcome|Moderate Dose Ondansetron (0.8 mg Bid)|Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
297012|NCT01254877|O2|Outcome|Low Dose Ondansetron (0.2 mg Bid)|ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks
297013|NCT01254877|O1|Outcome|Placebo Ondansetron - Sugar Pill|"Placebo is an oral preparation made to appear and taste like the active drug preparation.~placebo ondansetron: Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water."
297014|NCT01254877|O3|Outcome|Moderate Dose Ondansetron (0.8 mg Bid)|Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
297015|NCT01254877|O2|Outcome|Low Dose Ondansetron (0.2 mg Bid)|ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks
297016|NCT01254877|O1|Outcome|Placebo Ondansetron - Sugar Pill|"Placebo is an oral preparation made to appear and taste like the active drug preparation.~placebo ondansetron: Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water."
297017|NCT01254877|O3|Outcome|Moderate Dose Ondansetron (0.8 mg Bid)|Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
297018|NCT01254877|O2|Outcome|Low Dose Ondansetron (0.2 mg Bid)|ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks
297019|NCT01254877|O1|Outcome|Placebo Ondansetron - Sugar Pill|"Placebo is an oral preparation made to appear and taste like the active drug preparation.~placebo ondansetron: Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water."
297020|NCT01254877|O3|Outcome|Moderate Dose Ondansetron (0.8 mg Bid)|Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
297021|NCT01254877|O2|Outcome|Low Dose Ondansetron (0.2 mg Bid)|ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks
297022|NCT01254877|O1|Outcome|Placebo Ondansetron - Sugar Pill|"Placebo is an oral preparation made to appear and taste like the active drug preparation.~placebo ondansetron: Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water."
297023|NCT01254877|O3|Outcome|Moderate Dose Ondansetron (0.8 mg Bid)|Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
297024|NCT01254877|O2|Outcome|Low Dose Ondansetron (0.2 mg Bid)|ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks
297025|NCT01254877|O1|Outcome|Placebo Ondansetron - Sugar Pill|"Placebo is an oral preparation made to appear and taste like the active drug preparation.~placebo ondansetron: Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water."
297026|NCT01254877|O3|Outcome|Moderate Dose Ondansetron (0.8 mg Bid)|Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
297027|NCT01254877|O2|Outcome|Low Dose Ondansetron (0.2 mg Bid)|ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks
297028|NCT01254877|O1|Outcome|Placebo Ondansetron - Sugar Pill|"Placebo is an oral preparation made to appear and taste like the active drug preparation.~placebo ondansetron: Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water."
297029|NCT01254877|E3|Reported Event|Moderate Dose Ondansetron (0.8 mg Bid)|Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
297030|NCT01254877|E2|Reported Event|Low Dose Ondansetron (0.2 mg Bid)|ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks
297031|NCT01254877|E1|Reported Event|Placebo Ondansetron - Sugar Pill|"Placebo is an oral preparation made to appear and taste like the active drug preparation.~placebo ondansetron: Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water."
297032|NCT01254851|B3|Baseline|Total|Total of all reporting groups
297033|NCT01254851|B2|Baseline|Usual Care|routine post-operative ambulation
297035|NCT01254851|P2|Participant Flow|Usual Care|routine post-operative ambulation
297036|NCT01254851|P1|Participant Flow|Goal-augmented Post-operative Care.|Patients in this group will be given a goal number of steps to take on each post-operative day.
297037|NCT01254851|O2|Outcome|Usual Care|routine post-operative ambulation
297038|NCT01254851|O1|Outcome|Goal-augmented Post-operative Care.|Patients in this group will be given a goal number of steps to take on each post-operative day.
297039|NCT01254851|E2|Reported Event|Usual Care|routine post-operative ambulation
297040|NCT01254851|E1|Reported Event|Goal-augmented Post-operative Care.|Patients in this group will be given a goal number of steps to take on each post-operative day.
297041|NCT01254760|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed participants.
297042|NCT01254760|P2|Participant Flow|Commercial Multifocal / Investigational Multifocal|Commercial multifocal contact lenses worn first, with investigational multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.
297043|NCT01254760|P1|Participant Flow|Investigational Multifocal / Commercial Multifocal|Investigational multifocal contact lenses worn first, with commercial multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.
297044|NCT01254760|O2|Outcome|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
297045|NCT01254760|O1|Outcome|Nelfilcon A Investigational|Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
297046|NCT01254760|O2|Outcome|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn in bilaterally on a daily wear, daily disposable basis for 5 days
297047|NCT01254760|O1|Outcome|Nelfilcon A Investigational|Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
297048|NCT01254760|O2|Outcome|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
297049|NCT01254760|O1|Outcome|Nelfilcon A Investigational|Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
297050|NCT01254760|O2|Outcome|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
297051|NCT01254760|O1|Outcome|Nelfilcon A Investigational|Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
297052|NCT01254760|O2|Outcome|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
297053|NCT01254760|O1|Outcome|Nelfilcon A Investigational|Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
297054|NCT01254760|E2|Reported Event|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn in both eyes on a daily wear, daily disposable basis for 5 days
297055|NCT01254760|E1|Reported Event|Nelfilcon A Investigational|Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 5 days
297056|NCT01254747|B5|Baseline|Total|Total of all reporting groups
297057|NCT01254747|B4|Baseline|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297058|NCT01254747|B3|Baseline|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297059|NCT01254747|B2|Baseline|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297060|NCT01254747|B1|Baseline|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297061|NCT01254747|P4|Participant Flow|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297062|NCT01254747|P3|Participant Flow|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297063|NCT01254747|P2|Participant Flow|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297064|NCT01254747|P1|Participant Flow|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297065|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297066|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297067|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297068|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297069|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297070|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297071|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297072|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297073|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297074|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297075|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297076|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297077|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297078|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297079|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297080|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297081|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297082|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297083|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297084|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297085|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297086|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297087|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297088|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297089|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297090|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297091|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297092|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297093|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297094|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297095|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297096|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297097|NCT01254747|E4|Reported Event|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297098|NCT01254747|E3|Reported Event|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297099|NCT01254747|E2|Reported Event|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297100|NCT01254747|E1|Reported Event|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
297101|NCT01254721|B3|Baseline|Total|Total of all reporting groups
297102|NCT01254721|B2|Baseline|Seroquel XR + Lithium|"Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].~Treatment duration: 28 days"
297103|NCT01254721|B1|Baseline|Seroquel XR|"Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.~Treatment duration: 28 days"
297104|NCT01254721|P2|Participant Flow|Seroquel XR + Lithium|"Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].~Treatment duration: 28 days"
297105|NCT01254721|P1|Participant Flow|Seroquel XR|"Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.~Treatment duration: 28 days"
297106|NCT01254721|O2|Outcome|Seroquel XR + Lithium|"Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].~Treatment duration: 28 days"
297107|NCT01254721|O1|Outcome|Seroquel XR|"Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.~Treatment duration: 28 days"
297108|NCT01254721|O2|Outcome|Seroquel XR + Lithium|"Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].~Treatment duration: 28 days"
297109|NCT01254721|O1|Outcome|Seroquel XR|"Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.~Treatment duration: 28 days"
297110|NCT01254721|E2|Reported Event|Seroquel XR + Lithium|"Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].~Treatment duration: 28 days"
297111|NCT01254721|E1|Reported Event|Seroquel XR|"Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.~Treatment duration: 28 days"
297112|NCT01254669|B3|Baseline|Total|Total of all reporting groups
297113|NCT01254669|B2|Baseline|BNI/Intervention|One hundred mothers received intervention (n=50 Haitian, 50 African-American). Four Haitian mothers did not receive intervention because (i) One was called to see the clinical provider during the intervention and did not return (n=1), and (ii) time constraints (n=2), one for immigration status .
297114|NCT01254669|B1|Baseline|Standard of Care|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.~Of the 100 women in the Control Group (n=50 Haitian, 50 African-American), three African-American mothers did not complete Control Group activities because they did not complete the survey. Reasons for initial dropout/decline to participate included being too busy, not interested, time constraints, and daughter not sexually active upon hearing study has to do with HPV vaccine."
297137|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297115|NCT01254669|P2|Participant Flow|Brief Negotiated Inteview (BNI) Intervention|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.~One hundred mothers received intervention (n=50 Haitian, 50 African-American). Four Haitian mothers did not receive intervention because (i) One was called to see the clinical provider during the intervention and did not return (n=1), and (ii) time constraints (n=2) and one dropped out for fear information from study will affect her immigration status"
297116|NCT01254669|P1|Participant Flow|Standard of Care|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve Human Papilloma Virus (HPV) vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.~Mothers assigned to the Control Group received the low-literacy, standard-practice, HPV vaccine information sheet usually given to all patients prior to vaccination. Control mothers met once with the research assistant to collect demographic characteristics, HPV knowledge, and vaccine status of the daughter on the day of visit. No Brief Negotiated Intervention (BNI) counseling was provided."
297117|NCT01254669|O2|Outcome|Control Group|Did not receive any BNI intervention on the pre and post measure
297118|NCT01254669|O1|Outcome|BNI Post-educational Intervention Group|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.~Post-educational interventional assessment of HPV knowledge ranges from 0(minimal knowledge) to 12 (maximal knowledge)"
297119|NCT01254669|O2|Outcome|BNI/Intervention|Intervention was administered to 100 African-American and Haitian mothers over 10-20 minutes prior to seeing the health provider if the daughter had never received the HPV vaccine, or after seeing the health provider if the daughter did not received the vaccine during the visit.
297120|NCT01254669|O1|Outcome|Standard of Care|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.~Of the 100 women in the Control Group (n=50 Haitian, 50 African-American), received the standard of care handout given to patients on the vaccine they will be getting that day. three African-American mothers did not complete Control Group activities because they did not complete the survey. Reasons for initial dropout/decline to participate included being too busy, not interested, time constraints, and daughter not sexually active upon hearing study has to do with HPV vaccine."
297121|NCT01254669|E2|Reported Event|BNI/Intervention|One hundred mothers received intervention (n=50 Haitian, 50 African-American). . Four Haitian mothers did not receive intervention because (i) One was called to see the clinical provider during the intervention and did not return (n=1), and (ii) time constraints (n=2), one due to fear of information affecting immigration status.
297122|NCT01254669|E1|Reported Event|Standard of Care|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.~Of the 100 women in the Control Group (n=50 Haitian, 50 African-American), three African-American mothers did not complete Control Group activities because they did not complete the survey. Reasons for initial dropout/decline to participate included being too busy, not interested, time constraints, and daughter not sexually active upon hearing study has to do with HPV vaccine."
297123|NCT01254656|B4|Baseline|Total|Total of all reporting groups
297124|NCT01254656|B3|Baseline|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297125|NCT01254656|B2|Baseline|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297126|NCT01254656|B1|Baseline|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297127|NCT01254656|P3|Participant Flow|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297128|NCT01254656|P2|Participant Flow|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297129|NCT01254656|P1|Participant Flow|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297130|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297131|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297132|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297133|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297134|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297135|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297136|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297296|NCT01254409|O3|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297138|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297139|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297140|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297141|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297142|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297143|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297144|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297145|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297146|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297147|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297148|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297149|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297150|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297151|NCT01254656|E3|Reported Event|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297152|NCT01254656|E2|Reported Event|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297153|NCT01254656|E1|Reported Event|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
297154|NCT01254643|B1|Baseline|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
297155|NCT01254643|P1|Participant Flow|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine (V503), 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
297156|NCT01254643|O1|Outcome|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
297157|NCT01254643|O1|Outcome|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
297158|NCT01254643|O1|Outcome|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
297159|NCT01254643|O1|Outcome|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
297160|NCT01254643|O1|Outcome|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
297161|NCT01254643|E1|Reported Event|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
297162|NCT01254630|B5|Baseline|Total|Total of all reporting groups
297163|NCT01254630|B4|Baseline|Placebo-HM|Participants with HM randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.
297164|NCT01254630|B3|Baseline|Placebo-STM|Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.
297165|NCT01254630|B2|Baseline|V212-HM|Participants with HM randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.
297166|NCT01254630|B1|Baseline|V212-STM|Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.
297167|NCT01254630|P4|Participant Flow|Placebo-HM|Participants with HM randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.
297168|NCT01254630|P3|Participant Flow|Placebo-STM|Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.
297169|NCT01254630|P2|Participant Flow|V212-HM|Participants with HM randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.
297170|NCT01254630|P1|Participant Flow|V212-STM|Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.
297171|NCT01254630|O2|Outcome|Placebo-STM|Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.
297172|NCT01254630|O1|Outcome|V212-STM|Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.
297173|NCT01254630|O2|Outcome|Placebo-STM|Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.
297174|NCT01254630|O1|Outcome|V212-STM|Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.
297175|NCT01254630|O2|Outcome|Placebo-STM|Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.
297176|NCT01254630|O1|Outcome|V212-STM|Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.
297177|NCT01254630|O2|Outcome|Placebo-STM|Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.
297178|NCT01254630|O1|Outcome|V212-STM|Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.
297179|NCT01254630|O2|Outcome|Placebo-STM|Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.
297180|NCT01254630|O1|Outcome|V212-STM|Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.
297181|NCT01254630|O2|Outcome|Placebo-STM|Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.
297182|NCT01254630|O1|Outcome|V212-STM|Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.
297183|NCT01254630|E4|Reported Event|Placebo-HM|Participants with HM randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.
297184|NCT01254630|E3|Reported Event|Placebo-STM|Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.
297185|NCT01254630|E2|Reported Event|V212-HM|Participants with HM randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.
297186|NCT01254630|E1|Reported Event|V212-STM|Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.
297187|NCT01254604|B3|Baseline|Total|Total of all reporting groups
297188|NCT01254604|B2|Baseline|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
297189|NCT01254604|B1|Baseline|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
297190|NCT01254604|P2|Participant Flow|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
297191|NCT01254604|P1|Participant Flow|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
297192|NCT01254604|O2|Outcome|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
297193|NCT01254604|O1|Outcome|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
297194|NCT01254604|O2|Outcome|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
297195|NCT01254604|O1|Outcome|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
297196|NCT01254604|O2|Outcome|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
297197|NCT01254604|O1|Outcome|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
297198|NCT01254604|O2|Outcome|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
297199|NCT01254604|O1|Outcome|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
297200|NCT01254604|E2|Reported Event|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
297201|NCT01254604|E1|Reported Event|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
297202|NCT01254565|B7|Baseline|Total|Total of all reporting groups
297203|NCT01254565|B6|Baseline|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297204|NCT01254565|B5|Baseline|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297205|NCT01254565|B4|Baseline|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297206|NCT01254565|B3|Baseline|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297207|NCT01254565|B2|Baseline|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
297208|NCT01254565|B1|Baseline|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
297209|NCT01254565|P6|Participant Flow|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297210|NCT01254565|P5|Participant Flow|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297211|NCT01254565|P4|Participant Flow|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
298661|NCT01251315|B5|Baseline|N Acetyl Cysteine-B|N Acetyl Cysteine High dose group ( 1200mg oral X1)
297212|NCT01254565|P3|Participant Flow|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297213|NCT01254565|P2|Participant Flow|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
297214|NCT01254565|P1|Participant Flow|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
297215|NCT01254565|O6|Outcome|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297216|NCT01254565|O5|Outcome|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297217|NCT01254565|O4|Outcome|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297218|NCT01254565|O3|Outcome|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297219|NCT01254565|O2|Outcome|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
297220|NCT01254565|O1|Outcome|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
297221|NCT01254565|O6|Outcome|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297222|NCT01254565|O5|Outcome|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297223|NCT01254565|O4|Outcome|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297224|NCT01254565|O3|Outcome|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297225|NCT01254565|O2|Outcome|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
297226|NCT01254565|O1|Outcome|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
297227|NCT01254565|O6|Outcome|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297228|NCT01254565|O5|Outcome|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297229|NCT01254565|O4|Outcome|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297230|NCT01254565|O3|Outcome|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297231|NCT01254565|O2|Outcome|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
297232|NCT01254565|O1|Outcome|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
297233|NCT01254565|O6|Outcome|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297234|NCT01254565|O5|Outcome|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297235|NCT01254565|O4|Outcome|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297236|NCT01254565|O3|Outcome|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297237|NCT01254565|O2|Outcome|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
297238|NCT01254565|O1|Outcome|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
297239|NCT01254565|O6|Outcome|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297240|NCT01254565|O5|Outcome|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297241|NCT01254565|O4|Outcome|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297242|NCT01254565|O3|Outcome|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297243|NCT01254565|O2|Outcome|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
297244|NCT01254565|O1|Outcome|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
297245|NCT01254565|O6|Outcome|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297246|NCT01254565|O5|Outcome|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297247|NCT01254565|O4|Outcome|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297248|NCT01254565|O3|Outcome|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297249|NCT01254565|O2|Outcome|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
297250|NCT01254565|O1|Outcome|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
297251|NCT01254565|O6|Outcome|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297252|NCT01254565|O5|Outcome|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297253|NCT01254565|O4|Outcome|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297254|NCT01254565|O3|Outcome|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297255|NCT01254565|O2|Outcome|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
297256|NCT01254565|O1|Outcome|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
297257|NCT01254565|E6|Reported Event|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297258|NCT01254565|E5|Reported Event|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297259|NCT01254565|E4|Reported Event|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297260|NCT01254565|E3|Reported Event|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
297261|NCT01254565|E2|Reported Event|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
297262|NCT01254565|E1|Reported Event|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
297263|NCT01254409|B5|Baseline|Total|Total of all reporting groups
297264|NCT01254409|B4|Baseline|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297265|NCT01254409|B3|Baseline|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297266|NCT01254409|B2|Baseline|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297267|NCT01254409|B1|Baseline|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297268|NCT01254409|P4|Participant Flow|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297269|NCT01254409|P3|Participant Flow|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297270|NCT01254409|P2|Participant Flow|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297271|NCT01254409|P1|Participant Flow|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297272|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297273|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297274|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297275|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297276|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297277|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297278|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297279|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297280|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297281|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297282|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297283|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297284|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297285|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297286|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297287|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297288|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297289|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297290|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297291|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297292|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297293|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297294|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297295|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297297|NCT01254409|O2|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297298|NCT01254409|O1|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297299|NCT01254409|O3|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297300|NCT01254409|O2|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297301|NCT01254409|O1|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297302|NCT01254409|O3|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297303|NCT01254409|O2|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297304|NCT01254409|O1|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297305|NCT01254409|O3|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297306|NCT01254409|O2|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297307|NCT01254409|O1|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297308|NCT01254409|O3|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297309|NCT01254409|O2|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297310|NCT01254409|O1|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297311|NCT01254409|O3|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297312|NCT01254409|O2|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297313|NCT01254409|O1|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297314|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297315|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297316|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297317|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297318|NCT01254409|E4|Reported Event|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297319|NCT01254409|E3|Reported Event|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297320|NCT01254409|E2|Reported Event|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297321|NCT01254409|E1|Reported Event|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
297322|NCT01254396|B1|Baseline|Entire Study Population|Includes groups randomized to receive sildenafil 50 mg ODT under fasted condition first and sildenafil 50 mg ODT under fed condition first.
297323|NCT01254396|P2|Participant Flow|Sildenafil Fed First, Then Sildenafil Fasted|Single oral dose of sildenafil 50 mg ODT under fed condition in first intervention period; and single oral dose of sildenafil 50 mg ODT under fasted condition in second intervention period. A washout period of at least 1 day was maintained between each period.
297324|NCT01254396|P1|Participant Flow|Sildenafil Fasted First, Then Sildenafil Fed|Single oral dose of sildenafil 50 milligram (mg) orally disintegrating tablet (ODT) under fasted condition in first intervention period; and single oral dose of sildenafil 50 mg ODT under fed condition in second intervention period. A washout period of at least 1 day was maintained between each period.
297325|NCT01254396|O2|Outcome|Sildenafil 50 mg (Fed)|Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
297326|NCT01254396|O1|Outcome|Sildenafil 50 mg (Fasted)|Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
297327|NCT01254396|O2|Outcome|Sildenafil 50 mg (Fed)|Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
297328|NCT01254396|O1|Outcome|Sildenafil 50 mg (Fasted)|Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
297329|NCT01254396|O2|Outcome|Sildenafil 50 mg (Fed)|Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
297330|NCT01254396|O1|Outcome|Sildenafil 50 mg (Fasted)|Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
297331|NCT01254396|O2|Outcome|Sildenafil 50 mg (Fed)|Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
297332|NCT01254396|O1|Outcome|Sildenafil 50 mg (Fasted)|Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
297333|NCT01254396|O2|Outcome|Sildenafil 50 mg (Fed)|Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
297334|NCT01254396|O1|Outcome|Sildenafil 50 mg (Fasted)|Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
297335|NCT01254396|E2|Reported Event|Sildenafil 50 mg (Fed)|Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
297336|NCT01254396|E1|Reported Event|Sildenafil 50 mg (Fasted)|Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
297337|NCT01254344|B3|Baseline|Total|Total of all reporting groups
297338|NCT01254344|B2|Baseline|Ceftriaxone/Metronidazole|Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
297651|NCT01253421|O3|Outcome|HC-amisulpride|Subjects having no history of mental disorder who received amisulpride
297339|NCT01254344|B1|Baseline|Ertapenem|Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
297340|NCT01254344|P2|Participant Flow|Ceftriaxone/Metronidazole|Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
297341|NCT01254344|P1|Participant Flow|Ertapenem|Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
297342|NCT01254344|O2|Outcome|Ceftriaxone/Metronidazole|Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
297343|NCT01254344|O1|Outcome|Ertapenem|Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
297344|NCT01254344|O2|Outcome|Ceftriaxone/Metronidazole|Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
297345|NCT01254344|O1|Outcome|Ertapenem|Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
297346|NCT01254344|E2|Reported Event|Ceftriaxone/Metronidazole|Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
297347|NCT01254344|E1|Reported Event|Ertapenem|Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
297348|NCT01254331|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
297349|NCT01254331|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the European League Against Rheumatism (EULAR) category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
297350|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
297351|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
297352|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
297353|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
297354|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
297355|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
297356|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
297357|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
297358|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
297359|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
297360|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
297410|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297361|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
297362|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
297363|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
297364|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
297365|NCT01254331|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
297366|NCT01254318|B1|Baseline|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem-cell transplantation.
297367|NCT01254318|P1|Participant Flow|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
297368|NCT01254318|O1|Outcome|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
297369|NCT01254318|O1|Outcome|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
297370|NCT01254318|O1|Outcome|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
297371|NCT01254318|E1|Reported Event|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
297372|NCT01254305|B4|Baseline|Total|Total of all reporting groups
297373|NCT01254305|B3|Baseline|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.~Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
297374|NCT01254305|B2|Baseline|Levomilnacipran ER|40 - 120 mg Levomilnacipran ER capsules, oral administration, once daily for 8 weeks
297375|NCT01254305|B1|Baseline|Placebo|"Matching placebo capsules, oral administration~Placebo : Matching placebo capsules, oral administration, once daily dosing"
297376|NCT01254305|P3|Participant Flow|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.~Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
297377|NCT01254305|P2|Participant Flow|Levomilnacipran ER|40 -120 mg Levomilnacipran ER capsules, oral administration once daily for 8 weeks.
297378|NCT01254305|P1|Participant Flow|Placebo|Matching placebo capsules, oral administration, once daily dosing.
297379|NCT01254305|O3|Outcome|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.~Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
297380|NCT01254305|O2|Outcome|Levomilnacipran ER|40 - 120 mg Levomilnacipran ER capsules, oral administration once per day for 8 weeks.
297381|NCT01254305|O1|Outcome|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks
297647|NCT01253421|O3|Outcome|HC-amisulpride|Subjects having no history of mental disorder who received amisulpride
297382|NCT01254305|O3|Outcome|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.~Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
297383|NCT01254305|O2|Outcome|Levomilnacipran ER|40 - 120 mg Levomilnacipran ER capsules, oral administration once per day for 8 weeks
297384|NCT01254305|O1|Outcome|Placebo|Dose matched placebo capsules, oral administration for 8 weeks.
297385|NCT01254305|O3|Outcome|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.~Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
297386|NCT01254305|O2|Outcome|Levomilnacipran ER|40 - 120 mg Levomilnacipran ER capsules, oral administration in capsule form, once daily for 8 weeks
297387|NCT01254305|O1|Outcome|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks
297388|NCT01254305|E3|Reported Event|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.~Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
297389|NCT01254305|E2|Reported Event|Levomilnacipran ER|40 -120 mg Levomilnacipran ER capsules, oral administration, once daily for 8 weeks
297390|NCT01254305|E1|Reported Event|Placebo|"Matching placebo capsules, oral administration~Placebo : Matching placebo capsules, oral administration, once daily dosing"
297391|NCT01254292|B3|Baseline|Total|Total of all reporting groups
297392|NCT01254292|B2|Baseline|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297393|NCT01254292|B1|Baseline|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297394|NCT01254292|P2|Participant Flow|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297395|NCT01254292|P1|Participant Flow|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297396|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297397|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297398|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297399|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297400|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297401|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297402|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297403|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297404|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297405|NCT01254292|O1|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297406|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297407|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297408|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297409|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
298662|NCT01251315|B4|Baseline|Placebo-B|High dose oral X1
297411|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297412|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297413|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297414|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297415|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297416|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297417|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297418|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297419|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297420|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297421|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297422|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297423|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297424|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297425|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297426|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297427|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297428|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297429|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297430|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297431|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297432|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297433|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297434|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297435|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297436|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297437|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297438|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297439|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297440|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297441|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297442|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297443|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297444|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297445|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297446|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297447|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297448|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297449|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297450|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297451|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297452|NCT01254292|E2|Reported Event|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
297453|NCT01254292|E1|Reported Event|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
297454|NCT01254214|B3|Baseline|Total|Total of all reporting groups
297455|NCT01254214|B2|Baseline|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
297456|NCT01254214|B1|Baseline|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
297457|NCT01254214|P2|Participant Flow|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
297458|NCT01254214|P1|Participant Flow|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
297459|NCT01254214|O2|Outcome|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
297460|NCT01254214|O1|Outcome|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
297461|NCT01254214|O2|Outcome|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
297462|NCT01254214|O1|Outcome|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
297463|NCT01254214|O2|Outcome|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
297464|NCT01254214|O1|Outcome|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
297465|NCT01254214|O2|Outcome|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
297466|NCT01254214|O1|Outcome|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
297467|NCT01254214|O2|Outcome|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
297468|NCT01254214|O1|Outcome|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
297469|NCT01254214|E2|Reported Event|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
297470|NCT01254214|E1|Reported Event|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
297471|NCT01254188|B1|Baseline|Nilotinib|Nilotinib 300 mg BID
297472|NCT01254188|P1|Participant Flow|Nilotinib|Nilotinib 300 mg BID
297473|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
297474|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
297475|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
297476|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
297477|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
297478|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
297479|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
297480|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
297481|NCT01254188|E1|Reported Event|Nilotinib|Nilotinib 300 mg BID
297482|NCT01254045|B1|Baseline|All Study Participants|Includes groups randomized to one of six different sequences of three interventions (placebo, oxytocin 24IU, oxytocin 48IU).
297483|NCT01254045|P6|Participant Flow|Placebo 48IU, Oxytocin 48IU, Oxytocin 24IU/Placebo 24IU|intranasal placebo (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
297484|NCT01254045|P5|Participant Flow|Oxytocin 48IU, Placebo 48IU, Oxytocin 24IU/Placebo 24IU|intranasal oxytocin (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles ; intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
297648|NCT01253421|O2|Outcome|MDD-placebo|Subjects experiencing a current episode of major depression who received placebo
297485|NCT01254045|P4|Participant Flow|Oxytocin 24IU/Placebo 24IU, Oxytocin 48IU, Placebo 48IU|intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
297486|NCT01254045|P3|Participant Flow|Oxytocin 48IU, Oxytocin 24IU/Placebo 24IU, Placebo 48IU|intranasal oxytocin (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
297487|NCT01254045|P2|Participant Flow|Oxytocin 24IU/Placebo 24IU, Placebo 48IU, Oxytocin 48IU|intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
297488|NCT01254045|P1|Participant Flow|Placebo 48IU, Oxytocin 24IU/Placebo 24IU, Oxytocin 48IU|intranasal placebo (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (24 international units; 4IU per puff) and placebo (24 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
297489|NCT01254045|O3|Outcome|48IU OT|48 international units of intranasal oxytocin
297490|NCT01254045|O2|Outcome|24IU OT|24 international units of intranasal oxytocin and 24 IU of placebo
297491|NCT01254045|O1|Outcome|Placebo|placebo (48 IU)
297492|NCT01254045|O3|Outcome|48IU OT|48 international units of intranasal oxytocin
297493|NCT01254045|O2|Outcome|Oxytocin 24IU/Placebo 24IU|24 international units of intranasal oxytocin and 24 international units of placebo
297494|NCT01254045|O1|Outcome|Placebo|placebo (48IU)
297495|NCT01254045|E3|Reported Event|Intervention: Oxytocin 48IU|Three participants received Oxytocin 48IU at baseline. Two participants received Oxytocin 48IU at Time 2. Three participants received Oxytocin 48IU at Time 3. This study is a cross-over design.
297496|NCT01254045|E2|Reported Event|Intervention: Oxytocin 24IU/Placebo 24IU|Three participants received Oxytocin 24IU/Placebo 24IU at baseline. Three participants received Oxytocin 24IU/Placebo 24IU at Time 2. Two participants received Oxytocin 24IU/Placebo 24IU at Time 3. This study is a cross-over design.
297497|NCT01254045|E1|Reported Event|Intervention: Placebo 48IU|Two participants received placebo 48IU at baseline. Three participants received placebo 48IU at Time 2. Three participants received placebo 48IU at Time 3. This study is a cross-over design.
297498|NCT01253980|B3|Baseline|Total|Total of all reporting groups
297499|NCT01253980|B2|Baseline|Amoxicillin|Amoxicillin 20-30mg per kg 8 hourly for 5 days
297500|NCT01253980|B1|Baseline|Placebo|Placebo 20-30mg per kg 8 hourly for 5 days
297501|NCT01253980|P2|Participant Flow|Amoxicillin|Amoxicillin 20-30mg per kg 8 hourly for 5 days
297502|NCT01253980|P1|Participant Flow|Placebo|Placebo 20-30mg per kg 8 hourly for 5 days
297503|NCT01253980|O2|Outcome|Amoxicillin|Amoxicillin 20-30mg per kg 8 hourly for 5 days
297504|NCT01253980|O1|Outcome|Placebo|Placebo 20-30mg per kg 8 hourly for 5 days
297505|NCT01253980|E2|Reported Event|Amoxicillin|Amoxicillin 20-30mg per kg 8 hourly for 5 days
297506|NCT01253980|E1|Reported Event|Placebo|Placebo 20-30mg per kg 8 hourly for 5 days
297507|NCT01253902|B4|Baseline|Total|Total of all reporting groups
297508|NCT01253902|B3|Baseline|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
297509|NCT01253902|B2|Baseline|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
297510|NCT01253902|B1|Baseline|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
297511|NCT01253902|P3|Participant Flow|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
297512|NCT01253902|P2|Participant Flow|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
297513|NCT01253902|P1|Participant Flow|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
297514|NCT01253902|O3|Outcome|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
297515|NCT01253902|O2|Outcome|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
297516|NCT01253902|O1|Outcome|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
297517|NCT01253902|O3|Outcome|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
297518|NCT01253902|O2|Outcome|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
297519|NCT01253902|O1|Outcome|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
297520|NCT01253902|O3|Outcome|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
297521|NCT01253902|O2|Outcome|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
297522|NCT01253902|O1|Outcome|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
297523|NCT01253902|E3|Reported Event|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
297524|NCT01253902|E2|Reported Event|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
297525|NCT01253902|E1|Reported Event|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
297526|NCT01253824|B3|Baseline|Total|Total of all reporting groups
297527|NCT01253824|B2|Baseline|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol~IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
297528|NCT01253824|B1|Baseline|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol~NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
297529|NCT01253824|P2|Participant Flow|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol~IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
297530|NCT01253824|P1|Participant Flow|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol~NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
297531|NCT01253824|O2|Outcome|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol~IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
297532|NCT01253824|O1|Outcome|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol~NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
297533|NCT01253824|O2|Outcome|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol~IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
297534|NCT01253824|O1|Outcome|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol~NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
297535|NCT01253824|O2|Outcome|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol~IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
297536|NCT01253824|O1|Outcome|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol~NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
297537|NCT01253824|O2|Outcome|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol~IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
297538|NCT01253824|O1|Outcome|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol~NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
297539|NCT01253824|E2|Reported Event|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol~IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
297540|NCT01253824|E1|Reported Event|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol~NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
297541|NCT01253811|B1|Baseline|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
297542|NCT01253811|P1|Participant Flow|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
297543|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
297544|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
297545|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
297546|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
297649|NCT01253421|O1|Outcome|MDD-amisulpride|Subjects experiencing a current episode of major depression who received amisulpride
297547|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
297548|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
297549|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
297550|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
297551|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
297552|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
297553|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
297554|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
297555|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
297556|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
297557|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
297558|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
297650|NCT01253421|O4|Outcome|HC-placebo|Subjects having no history of mental disorder who received placebo
297559|NCT01253811|E1|Reported Event|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
297560|NCT01253642|B1|Baseline|Combination Phenelzine and Docetaxel|Patients receive phenelzine sulfate PO QD on days -7 to -4, and then BID on days -3 to 21. Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
297561|NCT01253642|P1|Participant Flow|Combination Phenelzine and Docetaxel|Patients receive phenelzine sulfate orally (PO) once daily (QD) on days -7 to -4, and then twice daily (BID) on days -3 to 21. Patients receive docetaxel intravenously (IV) over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
297562|NCT01253642|O1|Outcome|Combination Phenelzine and Docetaxel|Patients receive phenelzine sulfate orally (PO) once daily (QD) on days -7 to -4, and then twice daily (BID) on days -3 to 21. Patients receive docetaxel intravenously (IV) over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
297563|NCT01253642|O1|Outcome|Combination Phenelzine and Docetaxel|Patients receive phenelzine sulfate orally (PO) once daily (QD) on days -7 to -4, and then twice daily (BID) on days -3 to 21. Patients receive docetaxel intravenously (IV) over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
297564|NCT01253642|O1|Outcome|Combination Phenelzine and Docetaxel|Patients receive phenelzine sulfate orally (PO) once daily (QD) on days -7 to -4, and then twice daily (BID) on days -3 to 21. Patients receive docetaxel intravenously (IV) over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
297565|NCT01253642|O1|Outcome|Combination Phenelzine and Docetaxel|Patients receive phenelzine sulfate orally (PO) once daily (QD) on days -7 to -4, and then twice daily (BID) on days -3 to 21. Patients receive docetaxel intravenously (IV) over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
297566|NCT01253642|O1|Outcome|Combination Phenelzine and Docetaxel|Patients receive phenelzine sulfate orally (PO) once daily (QD) on days -7 to -4, and then twice daily (BID) on days -3 to 21. Patients receive docetaxel intravenously (IV) over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
297567|NCT01253642|O1|Outcome|Combination Phenelzine and Docetaxel|Patients receive phenelzine sulfate orally (PO) once daily (QD) on days -7 to -4, and then twice daily (BID) on days -3 to 21. Patients receive docetaxel intravenously (IV) over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
297568|NCT01253642|O1|Outcome|Combination Phenelzine and Docetaxel|Patients receive phenelzine sulfate orally (PO) once daily (QD) on days -7 to -4, and then twice daily (BID) on days -3 to 21. Patients receive docetaxel intravenously (IV) over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
297569|NCT01253642|O1|Outcome|Combination Phenelzine and Docetaxel|Patients receive phenelzine sulfate orally (PO) once daily (QD) on days -7 to -4, and then twice daily (BID) on days -3 to 21. Patients receive docetaxel intravenously (IV) over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
297570|NCT01253642|O1|Outcome|Combination Phenelzine and Docetaxel|Patients receive phenelzine sulfate PO QD on days -7 to -4, and then BID on days -3 to 21. Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
297571|NCT01253642|E1|Reported Event|Combination Phenelzine and Docetaxel|Patients receive phenelzine sulfate orally (PO) once daily (QD) on days -7 to -4, and then twice daily (BID) on days -3 to 21. Patients receive docetaxel intravenously (IV) over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
297572|NCT01253577|B1|Baseline|Sinus Stent|Participants sinuses were randomized to receive drug-coated sinus stent on one side and non-drug coated control stent on the contralateral side in a split-face design.
297573|NCT01253577|P1|Participant Flow|Sinus Stent|Participants sinuses were randomized to receive drug-coated sinus stent on one side and non-drug coated control stent on the contralateral side in a split-face design.
297574|NCT01253577|O2|Outcome|Non-coated Implant Side|Sinus stent without drug coating
297575|NCT01253577|O1|Outcome|Drug-Coated Implant Side|Sinus stent coated with steroid
297576|NCT01253577|O1|Outcome|All Subjects|
297577|NCT01253577|O2|Outcome|Non-coated Implant Side|Sinus stent without drug coating
297578|NCT01253577|O1|Outcome|Drug-Coated Implant Side|Sinus stent coated with steroid
297579|NCT01253577|E1|Reported Event|All Patients|Patients served as their own controls in the study, with a drug-coated stent placed on one sinus side and a non-drug-coated control placed on contralateral side. Therefore adverse events are listed for the entire 105-patient cohort rather than by treatment group.
297580|NCT01253564|B1|Baseline|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
297581|NCT01253564|P1|Participant Flow|Vemurafenib|Participants received vemurafenib tablets, 960 milligrams (mg), twice daily (BID), orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
297582|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
297583|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
297584|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
297585|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
297586|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
297587|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
297588|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
297589|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
297590|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
297591|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
297592|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
297593|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
297594|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
297595|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
297596|NCT01253564|E1|Reported Event|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
297597|NCT01253525|B1|Baseline|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297598|NCT01253525|P1|Participant Flow|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297599|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297600|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297601|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297602|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297603|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297604|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297605|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297606|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297607|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297608|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297609|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297610|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297611|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297612|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297613|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297614|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297615|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297616|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297617|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297618|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297619|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297620|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297621|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297622|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297623|NCT01253525|E1|Reported Event|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
297624|NCT01253447|B1|Baseline|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
297625|NCT01253447|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
297626|NCT01253447|O1|Outcome|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
297627|NCT01253447|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
297628|NCT01253421|B5|Baseline|Total|Total of all reporting groups
297629|NCT01253421|B4|Baseline|HC-placebo|Subjects having no history of mental disorder who received placebo
297630|NCT01253421|B3|Baseline|HC-amisulpride|Subjects having no history of mental disorder who received amisulpride
297631|NCT01253421|B2|Baseline|MDD-placebo|Subjects experiencing a current episode of major depression who received placebo
297632|NCT01253421|B1|Baseline|MDD-amisulpride|Subjects experiencing a current episode of major depression who received amisulpride
297633|NCT01253421|P5|Participant Flow|HC-placebo|Subjects having no history of mental disorder who are randomized to receive placebo
297634|NCT01253421|P4|Participant Flow|HC-amisulpride|Subjects having no history of mental disorder who are randomized to receive amisulpride
297635|NCT01253421|P3|Participant Flow|MDD-placebo|Subjects experiencing a current episode of major depression who are randomized to receive placebo
297636|NCT01253421|P2|Participant Flow|MDD-amisulpride|Subjects experiencing a current episode of major depression who are randomized to receive amisulpride
297637|NCT01253421|P1|Participant Flow|All Participants Prior to Randomization|All Participants went through Assessment, prior to randomization.
297638|NCT01253421|O4|Outcome|HC-placebo|Subjects having no history of mental disorder who received placebo
297639|NCT01253421|O3|Outcome|HC-amisulpride|Subjects having no history of mental disorder who received amisulpride
297640|NCT01253421|O2|Outcome|MDD-placebo|Subjects experiencing a current episode of major depression who received placebo
297641|NCT01253421|O1|Outcome|MDD-amisulpride|Subjects experiencing a current episode of major depression who received amisulpride
297642|NCT01253421|O4|Outcome|HC-placebo|Subjects having no history of mental disorder who received placebo
297643|NCT01253421|O3|Outcome|HC-amisulpride|Subjects having no history of mental disorder who received amisulpride
297644|NCT01253421|O2|Outcome|MDD-placebo|Subjects experiencing a current episode of major depression who received placebo
297645|NCT01253421|O1|Outcome|MDD-amisulpride|Subjects experiencing a current episode of major depression who received amisulpride
297646|NCT01253421|O4|Outcome|HC-placebo|Subjects having no history of mental disorder who received placebo
297652|NCT01253421|O2|Outcome|MDD-placebo|Subjects experiencing a current episode of major depression who received placebo
297653|NCT01253421|O1|Outcome|MDD-amisulpride|Subjects experiencing a current episode of major depression who received amisulpride
297654|NCT01253421|O4|Outcome|HC-placebo|Subjects having no history of mental disorder who received placebo
297655|NCT01253421|O3|Outcome|HC-amisulpride|Subjects having no history of mental disorder who received amisulpride
297656|NCT01253421|O2|Outcome|MDD-placebo|Subjects experiencing a current episode of major depression who received placebo
297657|NCT01253421|O1|Outcome|MDD-amisulpride|Subjects experiencing a current episode of major depression who received amisulpride
297658|NCT01253421|O4|Outcome|HC-placebo|Subjects having no history of mental disorder who received placebo
297659|NCT01253421|O3|Outcome|HC-amisulpride|Subjects having no history of mental disorder who received amisulpride
297660|NCT01253421|O2|Outcome|MDD-placebo|Subjects experiencing a current episode of major depression who received placebo
297661|NCT01253421|O1|Outcome|MDD-amisulpride|Subjects experiencing a current episode of major depression who received amisulpride
297662|NCT01253421|O4|Outcome|HC-placebo|Subjects having no history of mental disorder who received placebo
297663|NCT01253421|O3|Outcome|HC-amisulpride|Subjects having no history of mental disorder who received amisulpride
297664|NCT01253421|O2|Outcome|MDD-placebo|Subjects experiencing a current episode of major depression who received placebo
297665|NCT01253421|O1|Outcome|MDD-amisulpride|Subjects experiencing a current episode of major depression who received amisulpride
297666|NCT01253421|O4|Outcome|HC-placebo|Subjects having no history of mental disorder who received placebo
297667|NCT01253421|O3|Outcome|HC-amisulpride|Subjects having no history of mental disorder who received amisulpride
297668|NCT01253421|O2|Outcome|MDD-placebo|Subjects experiencing a current episode of major depression who received placebo
297669|NCT01253421|O1|Outcome|MDD-amisulpride|Subjects experiencing a current episode of major depression who received amisulpride
297670|NCT01253421|O4|Outcome|HC-placebo|Subjects having no history of mental disorder who received placebo
297671|NCT01253421|O3|Outcome|HC-amisulpride|Subjects having no history of mental disorder who received amisulpride
297672|NCT01253421|O2|Outcome|MDD-placebo|Subjects experiencing a current episode of major depression who received placebo
297673|NCT01253421|O1|Outcome|MDD-amisulpride|Subjects experiencing a current episode of major depression who received amisulpride
297674|NCT01253421|O4|Outcome|HC-placebo|Subjects having no history of mental disorder who received placebo
297675|NCT01253421|O3|Outcome|HC-amisulpride|Subjects having no history of mental disorder who received amisulpride
297676|NCT01253421|O2|Outcome|MDD-placebo|Subjects experiencing a current episode of major depression who received placebo
297677|NCT01253421|O1|Outcome|MDD-amisulpride|Subjects experiencing a current episode of major depression who received amisulpride
297678|NCT01253421|E4|Reported Event|HC-placebo|Subjects having no history of mental disorder who received placebo
297679|NCT01253421|E3|Reported Event|HC-amisulpride|Subjects having no history of mental disorder who received amisulpride
297680|NCT01253421|E2|Reported Event|MDD-placebo|Subjects experiencing a current episode of major depression who received placebo
297681|NCT01253421|E1|Reported Event|MDD-amisulpride|Subjects experiencing a current episode of major depression who received amisulpride
297682|NCT01253408|B4|Baseline|Total|Total of all reporting groups
297683|NCT01253408|B3|Baseline|Placebo|Placebo will be taken orally with water twice per day for two days.
297684|NCT01253408|B2|Baseline|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
297685|NCT01253408|B1|Baseline|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
297686|NCT01253408|P3|Participant Flow|Placebo|Placebo will be taken orally with water twice per day for two days.
297687|NCT01253408|P2|Participant Flow|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
297688|NCT01253408|P1|Participant Flow|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
297689|NCT01253408|O3|Outcome|Placebo|Placebo will be taken orally with water twice per day for two days.
297690|NCT01253408|O2|Outcome|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
297691|NCT01253408|O1|Outcome|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
297692|NCT01253408|O3|Outcome|Placebo|Placebo will be taken orally with water twice per day for two days.
297693|NCT01253408|O2|Outcome|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
297694|NCT01253408|O1|Outcome|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
297695|NCT01253408|O3|Outcome|Placebo|Placebo will be taken orally with water twice per day for two days.
297696|NCT01253408|O2|Outcome|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
297697|NCT01253408|O1|Outcome|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
297698|NCT01253408|O3|Outcome|Placebo|Placebo will be taken orally with water twice per day for two days.
297699|NCT01253408|O2|Outcome|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
297700|NCT01253408|O1|Outcome|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
297701|NCT01253408|O3|Outcome|Placebo|Placebo will be taken orally with water twice per day for two days.
297702|NCT01253408|O2|Outcome|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
297703|NCT01253408|O1|Outcome|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
297704|NCT01253408|O3|Outcome|Placebo|Placebo will be taken orally with water twice per day for two days.
297705|NCT01253408|O2|Outcome|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
297706|NCT01253408|O1|Outcome|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
297707|NCT01253408|E3|Reported Event|Placebo|Placebo will be taken orally with water twice per day for two days.
297708|NCT01253408|E2|Reported Event|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
297709|NCT01253408|E1|Reported Event|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
297710|NCT01253369|B1|Baseline|Pazopanib|Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
297711|NCT01253369|P1|Participant Flow|Pazopanib|Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
297712|NCT01253369|O1|Outcome|Pazopanib|Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
297713|NCT01253369|O1|Outcome|Pazopanib|Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
297714|NCT01253369|E1|Reported Event|Pazopanib|Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
297715|NCT01253343|B3|Baseline|Total|Total of all reporting groups
297716|NCT01253343|B2|Baseline|Inpatient Low Aggression|The low- risk group was defined as having a BRACHA score ≤6.5.
297717|NCT01253343|B1|Baseline|Inpatient High Aggression|The high- risk group was defined as having a BRACHA score ≥ 8.
297718|NCT01253343|P2|Participant Flow|Inpatient Low Aggression|The low- risk group was defined as having a BRACHA score <7.5.
297719|NCT01253343|P1|Participant Flow|Inpatient High Aggression|The high- risk group was defined as having a BRACHA score >7.5.
297720|NCT01253343|O12|Outcome|High Aggression Group + TestosteroneSample3|High Aggression= BRACHA Score >7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
297721|NCT01253343|O11|Outcome|High Aggression Group + TestosteroneSample2|High Aggression= BRACHA Score >7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
297722|NCT01253343|O10|Outcome|High Aggression Group + TestosteroneSample1|High Aggression= BRACHA Score >7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
297723|NCT01253343|O9|Outcome|High Aggression Group + DHEASample3|High Aggression= BRACHA Score >7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
297724|NCT01253343|O8|Outcome|High Aggression Group + DHEASample2|High Aggression= BRACHA Score >7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
297725|NCT01253343|O7|Outcome|High Aggression Group + DHEASample1|High Aggression= BRACHA Score >7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
297726|NCT01253343|O6|Outcome|Low Aggression Group + TestosteroneSample3|Low Aggression= BRACHA Score <7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
297727|NCT01253343|O5|Outcome|Low Aggression Group + TestosteroneSample2|Low Aggression= BRACHA Score <7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
297728|NCT01253343|O4|Outcome|Low Aggression Group + TestosteroneSample1|Low Aggression= BRACHA Score <7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
297729|NCT01253343|O3|Outcome|Low Aggression Group + DHEA Sample3|Low Aggression= BRACHA Score <7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
297730|NCT01253343|O2|Outcome|Low Aggression Group + DHEA Sample2|Low Aggression= BRACHA Score <7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
297731|NCT01253343|O1|Outcome|Low Aggression Group + DHEA Sample1|Low Aggression= BRACHA Score <7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
297732|NCT01253343|O6|Outcome|High Aggression Group + Cortisol Sample3|High Aggression= BRACHA Score >7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
297733|NCT01253343|O5|Outcome|High Aggression Group + Cortisol Sample2|High Aggression= BRACHA Score >7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
297734|NCT01253343|O4|Outcome|High Aggression Group + Cortisol Sample1|High Aggression= BRACHA Score >7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
297735|NCT01253343|O3|Outcome|Low Aggression Group + Cortisol Sample3|Low Aggression= BRACHA Score <7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
297736|NCT01253343|O2|Outcome|Low Aggression Group + Cortisol Sample2|Low Aggression= BRACHA Score <7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
297737|NCT01253343|O1|Outcome|Low Aggression Group + Cortisol Sample1|Low Aggression= BRACHA Score <7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
297738|NCT01253343|E2|Reported Event|Inpatient Low Aggression|The low- risk group was defined as having a BRACHA score <7.5.
297739|NCT01253343|E1|Reported Event|Inpatient High Aggression|The high- risk group was defined as having a BRACHA score >7.5.
297740|NCT01253317|B1|Baseline|Open-label IGF-1 Treatment|"Twelve girls with MECP2 mutations participated in the 4-week multiple ascending dose (MAD) period of open-label treatment with IGF-1 (mecasermin). The MAD focused on obtaining PK data, determining cerebrospinal fluid (CSF) penetration, evaluating safety and tolerability, and estimating feasibility of automated cardiorespiratory measures as biomarkers. Mecasermin was escalated over a 4-week period, beginning with twice daily injections of 40 mcg/kg the first week, 80 mcg/kg the second week, and 120 mcg/kg during the third and fourth weeks. CSF samples were obtained prior to initiating treatment and after completing the fourth week.~10 of these subjects went on to complete the open label extension (OLE). The OLE was designed to obtain additional information on safety, tolerability, and cardiorespiratory measures after 20-weeks of treatment, as well as preliminary data on neurologic and behavioral parameters. During the 20-week OLE subjects were evaluated every 5 weeks."
297765|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
297766|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
297741|NCT01253317|P1|Participant Flow|Open-label IGF-1 Treatment|"Twelve girls with MECP2 mutations participated in the 4-week multiple ascending dose (MAD) period of open-label treatment with IGF-1 (mecasermin). The MAD focused on obtaining PK data, determining cerebrospinal fluid (CSF) penetration, evaluating safety and tolerability, and estimating feasibility of automated cardiorespiratory measures as biomarkers. Mecasermin was escalated over a 4-week period, beginning with twice daily injections of 40 mcg/kg the first week, 80 mcg/kg the second week, and 120 mcg/kg during the third and fourth weeks. CSF samples were obtained prior to initiating treatment and after completing the fourth week.~10 of these subjects went on to complete the open label extension (OLE). The OLE was designed to obtain additional information on safety, tolerability, and cardiorespiratory measures after 20-weeks of treatment, as well as preliminary data on neurologic and behavioral parameters. During the 20-week OLE subjects were evaluated every 5 weeks."
297742|NCT01253317|O1|Outcome|20-week Open Label Extension (OLE)|10 subjects that previously participated in the MAD went on to complete the OLE and were monitored for safety of prolonged treatment (20 weeks).
297743|NCT01253317|O1|Outcome|MAD and OLE Treatment Periods|Twelve girls with MECP2 mutations participated in the 4-week multiple ascending dose (MAD) period of open-label treatment with IGF-1 (mecasermin). The MAD focused on obtaining PK data, determining cerebrospinal fluid (CSF) penetration, and evaluating safety and tolerability of IGF-1. Ten subjects that previously participated in the MAD went on to complete the OLE and were monitoring for safety of prolonged treatment (20 weeks).
297744|NCT01253317|O1|Outcome|Open-label IGF-1 Treatment|"Twelve girls with MECP2 mutations participated in the 4-week multiple ascending dose (MAD) period of open-label treatment with IGF-1 (mecasermin). The MAD focused on obtaining PK data, determining cerebrospinal fluid (CSF) penetration, evaluating safety and tolerability, and estimating feasibility of automated cardiorespiratory measures as biomarkers. Mecasermin was escalated over a 4-week period, beginning with twice daily injections of 40 mcg/kg the first week, 80 mcg/kg the second week, and 120 mcg/kg during the third and fourth weeks. CSF samples were obtained prior to initiating treatment and after completing the fourth week.~10 of these subjects went on to complete the open label extension (OLE). The OLE was designed to obtain additional information on safety, tolerability, and cardiorespiratory measures after 20-weeks of treatment, as well as preliminary data on neurologic and behavioral parameters. During the 20-week OLE subjects were evaluated every 5 weeks."
297745|NCT01253317|O2|Outcome|20-week Open Label Extension (OLE)|10 subjects that previously participated in the MAD went on to complete the OLE and were monitoring for safety of prolonged treatment (20 weeks).
297746|NCT01253317|O1|Outcome|4-week Multiple Ascending Dose (MAD)|Twelve girls with MECP2 mutations participated in the 4-week multiple ascending dose (MAD) period of open-label treatment with IGF-1 (mecasermin). The MAD focused on obtaining PK data, determining cerebrospinal fluid (CSF) penetration, and evaluating safety and tolerability of IGF-1.
297747|NCT01253317|E1|Reported Event|Open-label IGF-1 Treatment|"Twelve girls with MECP2 mutations participated in the 4-week multiple ascending dose (MAD) period of open-label treatment with IGF-1 (mecasermin). The MAD focused on obtaining PK data, determining cerebrospinal fluid (CSF) penetration, evaluating safety and tolerability, and estimating feasibility of automated cardiorespiratory measures as biomarkers. Mecasermin was escalated over a 4-week period, beginning with twice daily injections of 40 mcg/kg the first week, 80 mcg/kg the second week, and 120 mcg/kg during the third and fourth weeks. CSF samples were obtained prior to initiating treatment and after completing the fourth week.~10 of these subjects went on to complete the open label extension (OLE). The OLE was designed to obtain additional information on safety, tolerability, and cardiorespiratory measures after 20-weeks of treatment, as well as preliminary data on neurologic and behavioral parameters. During the 20-week OLE subjects were evaluated every 5 weeks."
297748|NCT01253304|B5|Baseline|Total|Total of all reporting groups
297749|NCT01253304|B4|Baseline|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
297750|NCT01253304|B3|Baseline|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
297751|NCT01253304|B2|Baseline|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
297752|NCT01253304|B1|Baseline|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
297753|NCT01253304|P4|Participant Flow|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection of LY2189265 on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
297754|NCT01253304|P3|Participant Flow|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection of LY2189265 on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
297755|NCT01253304|P2|Participant Flow|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection of LY2189265 on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
297756|NCT01253304|P1|Participant Flow|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
297757|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
297758|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
297759|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
297760|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
297761|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
297762|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
297763|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
297764|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
297812|NCT01253265|O5|Outcome|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
297767|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
297768|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
297769|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
297770|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
297771|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
297772|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
297773|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
297774|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
297775|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
297776|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
297777|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
297778|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
297779|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
297780|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
297781|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
297782|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
297783|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
297784|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
297785|NCT01253304|E4|Reported Event|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
297786|NCT01253304|E3|Reported Event|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
297787|NCT01253304|E2|Reported Event|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
297788|NCT01253304|E1|Reported Event|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
297789|NCT01253265|B6|Baseline|Total|Total of all reporting groups
297790|NCT01253265|B5|Baseline|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
297791|NCT01253265|B4|Baseline|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
297792|NCT01253265|B3|Baseline|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297793|NCT01253265|B2|Baseline|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297794|NCT01253265|B1|Baseline|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297795|NCT01253265|P5|Participant Flow|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
297796|NCT01253265|P4|Participant Flow|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
297797|NCT01253265|P3|Participant Flow|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297798|NCT01253265|P2|Participant Flow|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297799|NCT01253265|P1|Participant Flow|30 Milligram (mg) LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297800|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
297801|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297802|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297803|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297804|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
297805|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297806|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297807|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297808|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
297809|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297810|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297811|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297813|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
297814|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297815|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297816|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297817|NCT01253265|O5|Outcome|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
297818|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
297819|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297820|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297821|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297822|NCT01253265|O5|Outcome|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
297823|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
297824|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297825|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297826|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297827|NCT01253265|O5|Outcome|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
297828|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
297829|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297830|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297831|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297832|NCT01253265|O5|Outcome|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
297833|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
297834|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297835|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297836|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297837|NCT01253265|E5|Reported Event|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
297838|NCT01253265|E4|Reported Event|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
297839|NCT01253265|E3|Reported Event|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297840|NCT01253265|E2|Reported Event|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297841|NCT01253265|E1|Reported Event|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
297842|NCT01253200|B6|Baseline|Total|Total of all reporting groups
297843|NCT01253200|B5|Baseline|Not Randomized to Any Treatment Group|Subjects not Randomized to any treatment group and were not Roll-in subjects
297844|NCT01253200|B4|Baseline|Roll-In Control Catheter|The use of the Control Catheter was optional after the second study suspension in a Roll-in subject. Previously enrolled subjects prior to suspension were also classified as Roll-in subjects; not counted in endpoint analysis
297845|NCT01253200|B3|Baseline|Roll-In Blazer® Open-Irrigated Ablation Catheter|The use of the Blazer-Open Irrigated Catheter was required after the second study suspension. Previously enrolled subjects prior to suspension were also classified as Roll-in subjects; not counted in endpoint analysis.
297846|NCT01253200|B2|Baseline|Randomized Control Catheter|"Patients randomized to treatment with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter~Control Catheter: Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter"
297847|NCT01253200|B1|Baseline|Randomized Blazer® Open-Irrigated Ablation Catheter|Patients randomized to treatment with the Blazer® Open-Irrigated Ablation Catheter
297848|NCT01253200|P5|Participant Flow|Not Randomized to Any Treatment Group Subjects|Five subjects were not Randomized to any treatment group and were not Roll-in subjects.
297849|NCT01253200|P4|Participant Flow|Roll-in Control Catheter|The use of the Control Catheter was optional after the second study suspension in a Roll-in subject. Previously enrolled subjects prior to suspension were also classified as Roll-in subjects; not counted in endpoint analysis.
297850|NCT01253200|P3|Participant Flow|Roll-in Blazer Open Irrigated Subjects|The use of the Blazer-Open Irrigated Catheter was required after the second study suspension. Previously enrolled subjects prior to suspension were also classified as Roll-in subjects; not counted in endpoint analysis.
297851|NCT01253200|P2|Participant Flow|Randomized Control Catheter|"Randomized patients treated with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter~Control Catheter: Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter"
297852|NCT01253200|P1|Participant Flow|Randomized Blazer® Open-Irrigated Ablation Catheter|"Randomized Patients treated with the Blazer® Open-Irrigated Ablation Catheter~Blazer® Open-Irrigated Ablation Catheter: Blazer® Open-Irrigated Ablation Catheter"
297853|NCT01253200|O2|Outcome|Control Catheter|"Patients treated with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter~Control Catheter: Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter"
297854|NCT01253200|O1|Outcome|Blazer® Open-Irrigated Ablation Catheter|"Patients treated with the Blazer® Open-Irrigated Ablation Catheter~Blazer® Open-Irrigated Ablation Catheter: Blazer® Open-Irrigated Ablation Catheter"
297855|NCT01253200|O2|Outcome|Control Catheter|"Patients treated with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter~Control Catheter: Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter"
297856|NCT01253200|O1|Outcome|Blazer® Open-Irrigated Ablation Catheter|"Patients treated with the Blazer® Open-Irrigated Ablation Catheter~Blazer® Open-Irrigated Ablation Catheter: Blazer® Open-Irrigated Ablation Catheter"
297857|NCT01253200|O2|Outcome|Control Catheter|"Patients treated with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter~Control Catheter: Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter"
297858|NCT01253200|O1|Outcome|Blazer® Open-Irrigated Ablation Catheter|"Patients treated with the Blazer® Open-Irrigated Ablation Catheter~Blazer® Open-Irrigated Ablation Catheter: Blazer® Open-Irrigated Ablation Catheter"
297859|NCT01253200|O2|Outcome|Control Catheter|"Patients treated with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter~Control Catheter: Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter"
297860|NCT01253200|O1|Outcome|Blazer® Open-Irrigated Ablation Catheter|"Patients treated with the Blazer® Open-Irrigated Ablation Catheter~Blazer® Open-Irrigated Ablation Catheter: Blazer® Open-Irrigated Ablation Catheter"
297861|NCT01253200|E5|Reported Event|Non-Randomized to Any Treatment Group|"Five subjects were not randomized to any treatment group and were not Roll-in subjects. Therefore, these five subjects were not treated with the Blazer Open-irrigated catheter or a Control catheter.~Note that only subjects at risk for an adverse event (treated subjects) are included in the calculation of the adverse event rates"
297862|NCT01253200|E4|Reported Event|Roll-in Control Catheter|"Roll-in patients treated with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter (procedure patients)~Control Catheter: Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter~Note that only subjects at risk for an adverse event (treated subjects) are included in the calculation of the adverse event rates"
297863|NCT01253200|E3|Reported Event|Roll-in Blazer® Open-Irrigated Ablation Catheter|"Roll-in patients treated with the Blazer® Open-Irrigated Ablation Catheter (procedure patients)~Blazer® Open-Irrigated Ablation Catheter: Blazer® Open-Irrigated Ablation Catheter~Note that only subjects at risk for an adverse event (treated subjects) are included in the calculation of the adverse event rates"
297864|NCT01253200|E2|Reported Event|Randomized Control Catheter|"Randomized patients treated with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter (procedure patients)~Control Catheter: Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter~Note that only subjects at risk for an adverse event (treated subjects) are included in the calculation of the adverse event rates"
297865|NCT01253200|E1|Reported Event|Randomized Blazer® Open-Irrigated Ablation Catheter|"Randomized patients treated with the Blazer® Open-Irrigated Ablation Catheter (procedure patients)~Blazer® Open-Irrigated Ablation Catheter: Blazer® Open-Irrigated Ablation Catheter~Note that only subjects at risk for an adverse event (treated subjects) are included in the calculation of the adverse event rates"
297866|NCT01253187|B1|Baseline|Entire Study Population|Includes all participants treated
297867|NCT01253187|P6|Participant Flow|Treatment Sequence F: Metafolin, EE20/DRSP/L-5-MTHF Ca, YAZ|Metafolin for Period 1; EE20/DRSP/L-5-MTHF Ca for Period 2; YAZ for Period 3. Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP).
297868|NCT01253187|P5|Participant Flow|Treatment Sequence E: Metafolin, YAZ, EE20/DRSP/L-5-MTHF Ca|Metafolin for Period 1; YAZ for Period 2; EE20/DRSP/L-5-MTHF Ca for Period 3. Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) / EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]).
297869|NCT01253187|P4|Participant Flow|Treatment Sequence D: EE20/DRSP/L-5-MTHF Ca, Metafolin, YAZ|EE20/DRSP/L-5-MTHF Ca for Period 1; Metafolin for Period 2; YAZ for Period 3. EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP).
297870|NCT01253187|P3|Participant Flow|Treatment Sequence C: EE20/DRSP/L-5-MTHF Ca, YAZ, Metafolin|EE20/DRSP/L-5-MTHF Ca for Period 1; YAZ for Period 2; Metafolin for Period 3. EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) / Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]).
297896|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
297897|NCT01253187|E3|Reported Event|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca])
297871|NCT01253187|P2|Participant Flow|Treatment Sequence B: YAZ, Metafolin, EE20/DRSP/L-5-MTHF Ca|YAZ for Period 1; Metafolin for Period 2; EE20/DRSP/L-5-MTHF Ca for Period 3. YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) / Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]).
297872|NCT01253187|P1|Participant Flow|Treatment Sequence A: YAZ, EE20/DRSP/L-5-MTHF Ca, Metafolin|YAZ for Period 1; EE20/DRSP/L-5-MTHF Ca for Period 2; Metafolin for Period 3. YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) / EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]).
297873|NCT01253187|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297874|NCT01253187|O1|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca])
297875|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297876|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
297877|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297878|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
297879|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297880|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
297881|NCT01253187|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297882|NCT01253187|O1|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297883|NCT01253187|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297884|NCT01253187|O1|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297885|NCT01253187|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297886|NCT01253187|O1|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297887|NCT01253187|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium) [L-5-MTHF Ca]
297888|NCT01253187|O1|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297889|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297890|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
297891|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297892|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
297893|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297894|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
297895|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
298663|NCT01251315|B3|Baseline|Proimmune 200-A|Proimmune 200 low dose group (3000mg oral X 1)
297898|NCT01253187|E2|Reported Event|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca])
297899|NCT01253187|E1|Reported Event|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
297900|NCT01253174|B1|Baseline|Entire Study Population|Includes all participants treated
297901|NCT01253174|P6|Participant Flow|Treatment Sequence F: Metafolin, EE30/DRSP/L-5-MTHF Ca, Yasmin|Metafolin for Period 1; EE30/DRSP/L-5-MTHF Ca for Period 2; Yasmin for Period 3. Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP).
297902|NCT01253174|P5|Participant Flow|Treatment Sequence E: Metafolin, Yasmin, EE30/DRSP/L-5-MTHF Ca|Metafolin for Period 1; Yasmin for Period 2; EE30/DRSP/L-5-MTHF Ca for Period 3. Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) / EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]).
297903|NCT01253174|P4|Participant Flow|Treatment Sequence D: EE30/DRSP/L-5-MTHF Ca, Metafolin, Yasmin|EE30/DRSP/L-5-MTHF Ca for Period 1; Metafolin for Period 2; Yasmin for Period 3. EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP).
297904|NCT01253174|P3|Participant Flow|Treatment Sequence C: EE30/DRSP/L-5-MTHF Ca, Yasmin, Metafolin|EE30/DRSP/L-5-MTHF Ca for Period 1; Yasmin for Period 2; Metafolin for Period 3. EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) / Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]).
297905|NCT01253174|P2|Participant Flow|Treatment Sequence B: Yasmin, Metafolin, EE30/DRSP/L-5-MTHF Ca|Yasmin for Period 1; Metafolin for Period 2; EE30/DRSP/L-5-MTHF Ca for Period 3. Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) / Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]).
297906|NCT01253174|P1|Participant Flow|Treatment Sequence A: Yasmin, EE30/DRSP/L-5-MTHF Ca, Metafolin|Yasmin for Period 1; EE30/DRSP/L-5-MTHF Ca for Period 2; Metafolin for Period 3. Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) / EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]).
297907|NCT01253174|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297908|NCT01253174|O1|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297909|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297910|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
297911|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297912|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
297913|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297914|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
297915|NCT01253174|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297916|NCT01253174|O1|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297917|NCT01253174|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297918|NCT01253174|O1|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297919|NCT01253174|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297920|NCT01253174|O1|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297921|NCT01253174|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297922|NCT01253174|O1|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297923|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297924|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
297925|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297926|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
297927|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297928|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
297929|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297930|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
297931|NCT01253174|E3|Reported Event|L-5-MTHF Ca 0.451mg (Metafolin)|single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297932|NCT01253174|E2|Reported Event|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
297933|NCT01253174|E1|Reported Event|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
297934|NCT01253148|B1|Baseline|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma~TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
297935|NCT01253148|P1|Participant Flow|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma~TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
297936|NCT01253148|O1|Outcome|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma~TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
297937|NCT01253148|O1|Outcome|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma~TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
297938|NCT01253148|O1|Outcome|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma~TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
297939|NCT01253148|E1|Reported Event|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma~TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
298053|NCT01252810|O1|Outcome|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration.
297940|NCT01253135|B1|Baseline|All Participants|The original protocol (Version 1) called for weekly application of HP802-247 Vehicle alone to the appropriate wound and application of White Petrolatum once weekly to the other wound. After enrollment of the first 15 subjects, scabbing was noted over both wounds, making it impossible to determine the day of wound closure. It was conjectured that the wound environment was becoming too dry. Version 1 of the protocol was stopped and it was amended to Version 2, in which White Petrolatum as applied daily to both wounds. On the days that HP802-247 Vehicle was applied, the White Petrolatum was applied 5 min later to allow the fibrin matrix to mature. 25 subjects were enrolled under Version 2. All 40 subjects enrolled in the study were assessed for safety and the 25 subjects enrolled under Version 2 were assessed for wound closure.
297941|NCT01253135|P1|Participant Flow|All Participants|The original protocol (Version 1) called for weekly application of HP802-247 Vehicle alone to the appropriate wound and application of White Petrolatum once weekly to the other wound. After enrollment of the first 15 subjects, scabbing was noted over both wounds, making it impossible to determine the day of wound closure. It was conjectured that the wound environment was becoming too dry. Version 1 of the protocol was stopped and it was amended to Version 2, in which White Petrolatum as applied daily to both wounds. On the days that HP802-247 Vehicle was applied, the White Petrolatum was applied 5 min later to allow the fibrin matrix to mature. 25 subjects were enrolled under Version 2. All 40 subjects enrolled in the study were assessed for safety and the 25 subjects enrolled under Version 2 were assessed for wound closure.
297942|NCT01253135|O2|Outcome|Control|"White Petrolatum~White Petrolatum: Topical application~White petrolatum was applied daily to the appropriate wound."
297943|NCT01253135|O1|Outcome|Test Article|"802-247 Vehicle (fibrinogen)~Fibrin: Topical application of fibrinogen spray, followed by thrombin spray~HP802-247 Vehicle (260 µL) was applied to the appropriate wound on days 1, 8, and 15. White petrolatum was applied daily. On days 1, 8,and 15 it was applied 5 min after application of HP802-247 Vehicle, to allow the fibrin matrix to mature."
297944|NCT01253135|O2|Outcome|Test Article|"802-247 Vehicle (fibrinogen)~Fibrin: Topical application of fibrinogen spray, followed by thrombin spray~HP802-247 Vehicle (260 µL) was applied to the appropriate wound on days 1, 8, and 15. White petrolatum was applied daily. On days 1, 8,and 15 it was applied 5 min after application of HP802-247 Vehicle, to allow the fibrin matrix to mature."
297945|NCT01253135|O1|Outcome|Control|"White Petrolatum~White Petrolatum: Topical application~White petrolatum was applied daily to the appropriate wound."
297946|NCT01253135|E2|Reported Event|Test Article|"802-247 Vehicle (fibrinogen)~Fibrin: Topical application of fibrinogen spray, followed by thrombin spray~HP802-247 Vehicle (260 µL) was applied to the appropriate wound on days 1, 8, and 15. White petrolatum was applied daily. On days 1, 8,and 15 it was applied 5 min after application of HP802-247 Vehicle, to allow the fibrin matrix to mature."
297947|NCT01253135|E1|Reported Event|Control|"White Petrolatum~White Petrolatum: Topical application~White petrolatum was applied daily to the appropriate wound."
297948|NCT01253070|B1|Baseline|Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
297949|NCT01253070|P1|Participant Flow|Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
297950|NCT01253070|O2|Outcome|TKD Mutated Participants|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
297951|NCT01253070|O1|Outcome|ITD Mutated Participants|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
297952|NCT01253070|O2|Outcome|TKD Mutated Participants|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
297953|NCT01253070|O1|Outcome|ITD Mutated Participants|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
297954|NCT01253070|O2|Outcome|TKD Mutated Participants|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
297981|NCT01253018|E2|Reported Event|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
297955|NCT01253070|O1|Outcome|ITD Mutated Participants|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
297956|NCT01253070|E1|Reported Event|Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
297957|NCT01253044|B3|Baseline|Total|Total of all reporting groups
297958|NCT01253044|B2|Baseline|Present Centered Therapy|Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
297959|NCT01253044|B1|Baseline|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
297960|NCT01253044|P2|Participant Flow|Present Centered Therapy|Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
297961|NCT01253044|P1|Participant Flow|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
297962|NCT01253044|O2|Outcome|Present Centered Therapy|Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
297963|NCT01253044|O1|Outcome|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
297964|NCT01253044|O2|Outcome|Present Centered Therapy|Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
297965|NCT01253044|O1|Outcome|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
297966|NCT01253044|E2|Reported Event|Present Centered Therapy|Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
297967|NCT01253044|E1|Reported Event|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
297968|NCT01253018|B3|Baseline|Total|Total of all reporting groups
297969|NCT01253018|B2|Baseline|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in Robot Therapy combined with transition to task (TTT) practice of functional activities using the hemiparetic arm. Sessions were 3x/week x 60 minutes (45 min robot therapy + 15 min TTT)
297970|NCT01253018|B1|Baseline|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
297971|NCT01253018|P2|Participant Flow|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
297972|NCT01253018|P1|Participant Flow|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using 2 different robots in a sequential 4 week progression in 3 distinct modules: wrist, shoulder-elbow and alternating sessions of wrist and shoulder-elbow robot. Sessions were 3x/week x 60 minutes.
297973|NCT01253018|O2|Outcome|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
297974|NCT01253018|O1|Outcome|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
297975|NCT01253018|O2|Outcome|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
297976|NCT01253018|O1|Outcome|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
297977|NCT01253018|O2|Outcome|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in Robot Therapy combined with transition to task (TTT) practice of functional activities using the hemiparetic arm. Sessions were 3x/week x 60 minutes (45 min robot therapy + 15 min TTT)
297978|NCT01253018|O1|Outcome|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
297979|NCT01253018|O2|Outcome|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
297980|NCT01253018|O1|Outcome|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
297982|NCT01253018|E1|Reported Event|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
297983|NCT01252966|B3|Baseline|Total|Total of all reporting groups
297984|NCT01252966|B2|Baseline|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
297985|NCT01252966|B1|Baseline|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
297986|NCT01252966|P2|Participant Flow|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
297987|NCT01252966|P1|Participant Flow|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
297988|NCT01252966|O2|Outcome|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
297989|NCT01252966|O1|Outcome|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
297990|NCT01252966|O2|Outcome|Control Training|The computerized control training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function.
297991|NCT01252966|O1|Outcome|Cognitive Training|The computerized cognitive training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function.
297992|NCT01252966|O2|Outcome|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
297993|NCT01252966|O1|Outcome|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
297994|NCT01252966|O2|Outcome|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
297995|NCT01252966|O1|Outcome|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
297996|NCT01252966|O2|Outcome|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
297997|NCT01252966|O1|Outcome|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
297998|NCT01252966|E2|Reported Event|Control Training|
297999|NCT01252966|E1|Reported Event|Cognitive Training|
298000|NCT01252953|B3|Baseline|Total|Total of all reporting groups
298001|NCT01252953|B2|Baseline|Placebo Anacetrapib|Placebo anacetrapib: 1 tablet daily
298002|NCT01252953|B1|Baseline|Anacetrapib|Anacetrapib: 100mg tablet daily
298003|NCT01252953|P2|Participant Flow|Placebo Anacetrapib|Placebo anacetrapib: 1 tablet daily
298004|NCT01252953|P1|Participant Flow|Anacetrapib|Anacetrapib: 100mg tablet daily
298005|NCT01252953|O2|Outcome|Placebo Anacetrapib|Placebo anacetrapib: 1 tablet daily
298006|NCT01252953|O1|Outcome|Anacetrapib|Anacetrapib: 100mg daily
298007|NCT01252953|O2|Outcome|Placebo Anacetrapib|Placebo anacetrapib: 1 tablet daily
298008|NCT01252953|O1|Outcome|Anacetrapib|Anacetrapib: 100mg tablet daily
298009|NCT01252953|O2|Outcome|Placebo Anacetrapib|Placebo anacetrapib: 1 tablet daily
298010|NCT01252953|O1|Outcome|Anacetrapib|Anacetrapib: 100mg daily
298011|NCT01252953|O2|Outcome|Placebo Anacetrapib|Placebo anacetrapib: 1 tablet daily
298012|NCT01252953|O1|Outcome|Anacetrapib|Anacetrapib: 100mg tablet daily
298013|NCT01252953|E2|Reported Event|Placebo Anacetrapib|placebo anacetrapib: tablet, 1 tablet daily
298014|NCT01252953|E1|Reported Event|Anacetrapib|anacetrapib: tablet, 100mg daily
298015|NCT01252940|B3|Baseline|Total|Total of all reporting groups
298016|NCT01252940|B2|Baseline|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
298017|NCT01252940|B1|Baseline|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
298018|NCT01252940|P2|Participant Flow|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
298019|NCT01252940|P1|Participant Flow|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) at the beginning of the study.
298020|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
298021|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
298022|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
298023|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
298024|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
298025|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
298026|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
298027|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
298028|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
298029|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
298030|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
298031|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
298032|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
298033|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
298034|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
298035|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
298036|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
298037|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
298038|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
298039|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
298040|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
298041|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
298042|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
298043|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
298044|NCT01252940|E3|Reported Event|SBR/Delayed Switch (After Week 24)|The adverse events reported in this group are those that occurred after Week 24 in participants who were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study and switch to the FTC/RPV/TDF STR (Delayed Switch) at Week 24 visit.
298045|NCT01252940|E2|Reported Event|SBR/Delayed Switch (up to Week 24)|The adverse events reported in this group are those that occurred in the first 24 weeks of the study in participants who were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
298046|NCT01252940|E1|Reported Event|FTC/RPV/TDF|The adverse events reported in this group are those that occurred at any time during the study in participants who were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
298047|NCT01252810|B3|Baseline|Total|Total of all reporting groups
298048|NCT01252810|B2|Baseline|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration.
298049|NCT01252810|B1|Baseline|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration.
298050|NCT01252810|P2|Participant Flow|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration.
298051|NCT01252810|P1|Participant Flow|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration.
298052|NCT01252810|O2|Outcome|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration.
298054|NCT01252810|O2|Outcome|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration.
298055|NCT01252810|O1|Outcome|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration.
298056|NCT01252810|O2|Outcome|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration.
298057|NCT01252810|O1|Outcome|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration.
298058|NCT01252810|E2|Reported Event|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration. Up to 7 days post Ioforminol administration.
298059|NCT01252810|E1|Reported Event|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration. Up to 7 days post Iopamidol administration.
298060|NCT01252745|B4|Baseline|Total|Total of all reporting groups
298061|NCT01252745|B3|Baseline|11.25 mg Testosterone t.i.d.|TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day)
298062|NCT01252745|B2|Baseline|13.5 mg Testosterone b.i.d.|TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day)
298063|NCT01252745|B1|Baseline|10.0 mg Testosterone t.i.d.|TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day)
298064|NCT01252745|P3|Participant Flow|11.25 mg Testosterone t.i.d.|TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day)
298065|NCT01252745|P2|Participant Flow|13.5 mg Testosterone b.i.d.|TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day)
298066|NCT01252745|P1|Participant Flow|10.0 mg Testosterone t.i.d.|TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day)
298067|NCT01252745|O3|Outcome|11.25 mg Testosterone t.i.d.|TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day)
298068|NCT01252745|O2|Outcome|13.5 mg Testosterone b.i.d.|TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day)
298069|NCT01252745|O1|Outcome|10.0 mg Testosterone t.i.d.|TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day)
298070|NCT01252745|O3|Outcome|11.25 mg of TBS-1, 4.5% T.I.D|"TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day)~11.25 mg of Testosterone, 4.5% T.I.D"
298071|NCT01252745|O2|Outcome|13.5 mg of TBS-1, 4.5% B.I.D|"TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day)~13.5 mg of Testosterone, 4.5% B.I.D"
298072|NCT01252745|O1|Outcome|10.0 mg of TBS-1, 4.0% T.I.D.|"TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day)~10.0 mg of Testosterone, 4.0% TID"
298073|NCT01252745|O3|Outcome|11.25 mg Testosterone t.i.d.|TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day)
298074|NCT01252745|O2|Outcome|13.5 mg Testosterone b.i.d.|TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day)
298075|NCT01252745|O1|Outcome|10.0 mg Testosterone t.i.d.|TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day)
298076|NCT01252745|E3|Reported Event|11.25 mg Testosterone t.i.d.|TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day)
298077|NCT01252745|E2|Reported Event|13.5 mg Testosterone b.i.d.|TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day)
298078|NCT01252745|E1|Reported Event|10.0 mg Testosterone t.i.d.|TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day)
298079|NCT01252355|B4|Baseline|Total|Total of all reporting groups
298080|NCT01252355|B3|Baseline|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
298081|NCT01252355|B2|Baseline|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
298082|NCT01252355|B1|Baseline|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
298083|NCT01252355|P3|Participant Flow|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
298084|NCT01252355|P2|Participant Flow|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
298085|NCT01252355|P1|Participant Flow|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
298086|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
298087|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
298088|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
298089|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
298090|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
298091|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
298092|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
298093|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
298094|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
298095|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
298096|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
298097|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
298098|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
298099|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
298100|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
298101|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
298102|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
298103|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
298104|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
298105|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
298106|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
298107|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
298108|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
298109|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
298110|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
298111|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
298112|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
298113|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
298114|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
298115|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
298116|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
298117|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
298118|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
298119|NCT01252355|E3|Reported Event|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
298120|NCT01252355|E2|Reported Event|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
298121|NCT01252355|E1|Reported Event|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
298122|NCT01252290|B1|Baseline|Lovaza™|Lovaza™: 4 capsules daily for 6 months
298123|NCT01252290|P1|Participant Flow|Lovaza™|Lovaza™: 4 capsules daily for 6 months
298124|NCT01252290|O1|Outcome|Lovaza™|Lovaza™: 4 capsules daily for 6 months
298125|NCT01252290|O1|Outcome|Lovaza™|Lovaza™: 4 capsules daily for 6 months
298126|NCT01252290|O1|Outcome|Lovaza™|Lovaza™: 4 capsules daily for 6 months
298127|NCT01252290|O1|Outcome|Lovaza™|Lovaza™: 4 capsules daily for 6 months
298128|NCT01252290|O1|Outcome|Lovaza™|Lovaza™: 4 capsules daily for 6 months
298129|NCT01252290|E1|Reported Event|Lovaza™|Lovaza™: 4 capsules daily for 6 months
298130|NCT01252277|B1|Baseline|Lovaza™|Lovaza™ (two 1 gram capsules twice daily) for six months
298131|NCT01252277|P1|Participant Flow|Lovaza™|Lovaza™: 4 capsules (total of 1860 mg EPA + 1500 mg DHA) daily for 6 months
298132|NCT01252277|O1|Outcome|Lovaza™|Lovaza™: 4 capsules (total of 1860 mg EPA + 1500 mg DHA) daily for 6 months
298133|NCT01252277|O1|Outcome|Lovaza™|Lovaza™: 4 capsules (total of 1860 mg EPA + 1500 mg DHA) daily for 6 months
298134|NCT01252277|O1|Outcome|Lovaza™|Lovaza™: 4 capsules (total of 1860 mg EPA + 1500 mg DHA) daily for 6 months
298135|NCT01252277|O1|Outcome|Lovaza™|Lovaza™: 4 capsules (total of 1860 mg EPA + 1500 mg DHA) daily for 6 months
298136|NCT01252277|O1|Outcome|Lovaza™|Lovaza™: 4 capsules daily for 6 months
298137|NCT01252277|E1|Reported Event|Lovaza™|"Lovaza™ (two 1 gram capsules twice daily) for six months~Lovaza™: 4 capsules daily for 6 months"
298138|NCT01252251|B1|Baseline|RAD001 and Pasireotide LAR|"This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.~RAD001 (Everolimus) and Pasireotide (SOM230) LAR: Patients will be treated with SOM-230 (pasireotide) LAR 60mg IM once every 28 days and with RAD001 (Everolimus) 10mg PO daily. Each cycle is 28 days. An optional biopsy may be requested required after weeks of therapy. The biopsy may be performed between days 28 and 42."
298139|NCT01252251|P1|Participant Flow|RAD001 and Pasireotide LAR|"This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.~RAD001 (Everolimus) and Pasireotide (SOM230) LAR: Patients will be treated with SOM-230 (pasireotide) LAR 60mg IM once every 28 days and with RAD001 (Everolimus) 10mg PO daily. Each cycle is 28 days. An optional biopsy may be requested required after weeks of therapy. The biopsy may be performed between days 28 and 42."
298140|NCT01252251|O1|Outcome|RAD001 and Pasireotide LAR|"This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.~RAD001 (Everolimus) and Pasireotide (SOM230) LAR: Patients will be treated with SOM-230 (pasireotide) LAR 60mg IM once every 28 days and with RAD001 (Everolimus) 10mg PO daily. Each cycle is 28 days. An optional biopsy may be requested required after weeks of therapy. The biopsy may be performed between days 28 and 42."
298256|NCT01252134|O1|Outcome|Synergi|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
298257|NCT01252134|O3|Outcome|OTE Elements|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
298141|NCT01252251|O1|Outcome|RAD001 and Pasireotide LAR|"This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.~RAD001 (Everolimus) and Pasireotide (SOM230) LAR: Patients will be treated with SOM-230 (pasireotide) LAR 60mg IM once every 28 days and with RAD001 (Everolimus) 10mg PO daily. Each cycle is 28 days. An optional biopsy may be requested required after weeks of therapy. The biopsy may be performed between days 28 and 42."
298142|NCT01252251|O1|Outcome|RAD001 and Pasireotide LAR|"This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.~RAD001 (Everolimus) and Pasireotide (SOM230) LAR: Patients will be treated with SOM-230 (pasireotide) LAR 60mg IM once every 28 days and with RAD001 (Everolimus) 10mg PO daily. Each cycle is 28 days. An optional biopsy may be requested required after weeks of therapy. The biopsy may be performed between days 28 and 42."
298143|NCT01252251|O1|Outcome|RAD001 and Pasireotide LAR|"This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.~RAD001 (Everolimus) and Pasireotide (SOM230) LAR: Patients will be treated with SOM-230 (pasireotide) LAR 60mg IM once every 28 days and with RAD001 (Everolimus) 10mg PO daily. Each cycle is 28 days. An optional biopsy may be requested required after weeks of therapy. The biopsy may be performed between days 28 and 42."
298144|NCT01252251|O1|Outcome|RAD001 and Pasireotide LAR|"This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.~RAD001 (Everolimus) and Pasireotide (SOM230) LAR: Patients will be treated with SOM-230 (pasireotide) LAR 60mg IM once every 28 days and with RAD001 (Everolimus) 10mg PO daily. Each cycle is 28 days. An optional biopsy may be requested required after weeks of therapy. The biopsy may be performed between days 28 and 42."
298145|NCT01252251|O1|Outcome|RAD001 and Pasireotide LAR|"This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.~RAD001 (Everolimus) and Pasireotide (SOM230) LAR: Patients will be treated with SOM-230 (pasireotide) LAR 60mg IM once every 28 days and with RAD001 (Everolimus) 10mg PO daily. Each cycle is 28 days. An optional biopsy may be requested required after weeks of therapy. The biopsy may be performed between days 28 and 42."
298146|NCT01252251|E1|Reported Event|RAD001 and Pasireotide LAR|"This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.~RAD001 (Everolimus) and Pasireotide (SOM230) LAR: Patients will be treated with SOM-230 (pasireotide) LAR 60mg IM once every 28 days and with RAD001 (Everolimus) 10mg PO daily. Each cycle is 28 days. An optional biopsy may be requested required after weeks of therapy. The biopsy may be performed between days 28 and 42."
298147|NCT01252238|B4|Baseline|Total|Total of all reporting groups
298148|NCT01252238|B3|Baseline|Valsartan and Aliskiren|"Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)~Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren."
298149|NCT01252238|B2|Baseline|Placebo Group|"Only taking Amlodipine~Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure."
298150|NCT01252238|B1|Baseline|Aliskiren|Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
298151|NCT01252238|P3|Participant Flow|Valsartan and Aliskiren|"Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)~Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren."
298152|NCT01252238|P2|Participant Flow|Placebo Group|"Only taking Amlodipine~Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure."
298153|NCT01252238|P1|Participant Flow|Aliskiren|Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
298154|NCT01252238|O3|Outcome|Placebo Group|"Only taking Amlodipine~Amlodipine: Taking Amlodipine as prescribed by MD for management of high blood pressure."
298155|NCT01252238|O2|Outcome|Aliskiren|Aliskiren: Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
298156|NCT01252238|O1|Outcome|Valsartan and Aliskiren|"Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)~Valsartan and Aliskiren: Subject taking combination of valsartan and aliskiren."
298157|NCT01252238|O3|Outcome|Placebo Group|"Only taking Amlodipine~Amlodipine: Taking Amlodipine as prescribed by MD for management of high blood pressure."
298158|NCT01252238|O2|Outcome|Aliskiren|Aliskiren: Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
298159|NCT01252238|O1|Outcome|Valsartan and Aliskiren|"Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)~Valsartan and Aliskiren: Subject taking combination of valsartan and aliskiren."
298160|NCT01252238|O3|Outcome|Valsartan and Aliskiren|"Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)~Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren."
298161|NCT01252238|O2|Outcome|Placebo Group|"Only taking Amlodipine~Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure."
298162|NCT01252238|O1|Outcome|Aliskiren|Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
298163|NCT01252238|E3|Reported Event|Valsartan and Aliskiren|"Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)~Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren."
298164|NCT01252238|E2|Reported Event|Placebo Group|"Only taking Amlodipine~Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure."
298165|NCT01252238|E1|Reported Event|Aliskiren|Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
298166|NCT01252186|B4|Baseline|Total|Total of all reporting groups
298167|NCT01252186|B3|Baseline|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298168|NCT01252186|B2|Baseline|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298169|NCT01252186|B1|Baseline|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
298170|NCT01252186|P3|Participant Flow|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298300|NCT01251770|E2|Reported Event|ClNa 0.45%|maintenance solution with ClNa 0.45%
298171|NCT01252186|P2|Participant Flow|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298172|NCT01252186|P1|Participant Flow|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
298173|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298174|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298175|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
298176|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298177|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298178|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
298179|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298180|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298181|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
298182|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298183|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298184|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
298185|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298186|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298187|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
298188|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298189|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298190|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
298191|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298192|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298193|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
298194|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298195|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298221|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298196|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
298197|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298198|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298199|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
298200|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298201|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298202|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
298203|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298204|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298205|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
298206|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298207|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298208|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
298209|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298210|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298211|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
298212|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298213|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298214|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
298215|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298216|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298217|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
298218|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298219|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298220|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
298222|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298223|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
298224|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298225|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298226|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
298227|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298228|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298229|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
298230|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298231|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298232|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
298233|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298234|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298235|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
298236|NCT01252186|E3|Reported Event|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298237|NCT01252186|E2|Reported Event|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
298238|NCT01252186|E1|Reported Event|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
298239|NCT01252147|B1|Baseline|All Participants|
298240|NCT01252147|P1|Participant Flow|All Participants|
298241|NCT01252147|O1|Outcome|All Participants|
298242|NCT01252147|O1|Outcome|All Participants|
298243|NCT01252147|E1|Reported Event|All Participants|
298244|NCT01252134|B1|Baseline|Overall|All enrolled participants
298245|NCT01252134|P6|Participant Flow|OTE, Then Synergi, Then Biotrue|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
298246|NCT01252134|P5|Participant Flow|OTE, Then Biotrue, Then Synergi|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
298247|NCT01252134|P4|Participant Flow|Biotrue, Then Synergi, Then OTE|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
298248|NCT01252134|P3|Participant Flow|Biotrue, Then OTE, Then Synergi|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
298249|NCT01252134|P2|Participant Flow|Synergi, Then OTE, Then Biotrue|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
298250|NCT01252134|P1|Participant Flow|Synergi, Then Biotrue, Then OTE|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
298251|NCT01252134|O3|Outcome|OTE Elements|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
298252|NCT01252134|O2|Outcome|Bio-True|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
298253|NCT01252134|O1|Outcome|Synergi|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
298254|NCT01252134|O3|Outcome|OTE Elements|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
298255|NCT01252134|O2|Outcome|Bio-True|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
298301|NCT01251770|E1|Reported Event|ClNa 0.3%|maintenance solution with ClNa 0.3%
298258|NCT01252134|O2|Outcome|Bio-True|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
298259|NCT01252134|O1|Outcome|Synergi|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
298260|NCT01252134|O3|Outcome|OTE Elements|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
298261|NCT01252134|O2|Outcome|Bio-True|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
298262|NCT01252134|O1|Outcome|Synergi|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
298263|NCT01252134|E3|Reported Event|OTE Elements|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
298264|NCT01252134|E2|Reported Event|Bio-True|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
298265|NCT01252134|E1|Reported Event|Synergi|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
298266|NCT01252095|B3|Baseline|Total|Total of all reporting groups
298267|NCT01252095|B2|Baseline|50 mg Dose|50 mg PG545/week
298268|NCT01252095|B1|Baseline|25 mg Dose|25 mg PG545/week
298269|NCT01252095|P2|Participant Flow|50 mg Dose|50 mg PG545/week
298270|NCT01252095|P1|Participant Flow|25 mg Dose|25 mg PG545/week
298271|NCT01252095|O2|Outcome|50 mg Dose|50 mg PG545/week
298272|NCT01252095|O1|Outcome|25 mg Dose|25 mg PG545/week
298273|NCT01252095|E2|Reported Event|50 mg Dose|50 mg PG545/week
298274|NCT01252095|E1|Reported Event|25 mg Dose|25 mg PG545/week
298275|NCT01251978|B3|Baseline|Total|Total of all reporting groups
298276|NCT01251978|B2|Baseline|Standard Dose Ranibizumab|"patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.~0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months."
298277|NCT01251978|B1|Baseline|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.~Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
298278|NCT01251978|P2|Participant Flow|Standard Dose Ranibizumab|"patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.~0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months."
298279|NCT01251978|P1|Participant Flow|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.~Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
298280|NCT01251978|O2|Outcome|Standard Dose Ranibizumab|"patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.~0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months."
298281|NCT01251978|O1|Outcome|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.~Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
298282|NCT01251978|O2|Outcome|Standard Dose Ranibizumab|"patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.~0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months."
298283|NCT01251978|O1|Outcome|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.~Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
298284|NCT01251978|O1|Outcome|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.~Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
298285|NCT01251978|E2|Reported Event|Standard Dose Ranibizumab|"patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.~0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months."
298286|NCT01251978|E1|Reported Event|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.~Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
298287|NCT01251952|B1|Baseline|Denileukin Diftitox (Ontak)|"Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.~Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.~Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360."
298288|NCT01251952|P1|Participant Flow|Denileukin Diftitox (Ontak)|"Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.~Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.~Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360."
298289|NCT01251952|O1|Outcome|Denileukin Diftitox (Ontak)|"Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.~Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.~Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360."
298290|NCT01251952|E1|Reported Event|Denileukin Diftitox (Ontak)|"Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.~Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.~Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360."
298291|NCT01251770|B3|Baseline|Total|Total of all reporting groups
298292|NCT01251770|B2|Baseline|ClNa 0.45%|maintenance solution with ClNa 0.45%
298293|NCT01251770|B1|Baseline|ClNa 0.3%|maintenance solution with ClNa 0.3%
298294|NCT01251770|P2|Participant Flow|ClNa 0.45%|maintenance solution with ClNa 0.45%
298295|NCT01251770|P1|Participant Flow|ClNa 0.3%|maintenance solution with ClNa 0.3%
298296|NCT01251770|O2|Outcome|ClNa 0.45%|maintenance solution with ClNa 0.45%
298297|NCT01251770|O1|Outcome|ClNa 0.3%|maintenance solution with ClNa 0.3%
298298|NCT01251770|O2|Outcome|ClNa 0.45%|maintenance solution with ClNa 0.45%
298299|NCT01251770|O1|Outcome|ClNa 0.3%|maintenance solution with ClNa 0.3%
298303|NCT01251757|B3|Baseline|Enhanced IVR (IVR+)|"Participants in the IVR+ arm received all components of the IVR intervention and in addition were mailed educational materials bimonthly during the intervention. In addition, both IVR+ participants and their primary care providers received mailed notifications when they did not fill their medications in response to the automated calls.~The educational mailings included personalized health information such as the participant's cholesterol and blood pressure readings, as well as tools for improving adherence such as FAQs about their medications, a pocket-sized calendar for tracking refills with pertinent phone numbers and web site information and space for them to write their medical record number and prescription numbers."
298304|NCT01251757|B2|Baseline|Interactive Voice Recognition (IVR)|"In addition to their usual care, participants in the Interactive Voice Recognition (IVR) arm received automated phone calls, triggered by dispensing events in the electronic medical record (EMR), to educate patients about their medications and assist them in refilling their prescriptions.~The calls fell into two basic types: simple refill reminders and tardy calls for those who were overdue for a refill. Calls occured monthly and were triggered by dispensing information in the EMR. Call features included the ability to transfer individuals to Kaiser's automated prescription refill service as well as to care managers. Although the calls were triggered by and focused on use of ACE inhibitors, ARBs and statins, they also included reminders to use aspirin, which is known to also be effective for secondary prevention in this patient population."
298305|NCT01251757|B1|Baseline|Usual Care (UC)|Participants in this arm had full access to all care they were normally entitled to as part of usual care
298306|NCT01251757|P3|Participant Flow|Enhanced IVR (IVR+)|"Participants in the IVR+ arm received all components of the IVR intervention and in addition were mailed educational materials bimonthly during the intervention. In addition, both IVR+ participants and their primary care providers received mailed notifications when they did not fill their medications in response to the automated calls.~The educational mailings included personalized health information such as the participant's cholesterol and blood pressure readings, as well as tools for improving adherence such as FAQs about their medications, a pocket-sized calendar for tracking refills with pertinent phone numbers and web site information and space for them to write their medical record number and prescription numbers."
298307|NCT01251757|P2|Participant Flow|Interactive Voice Recognition (IVR)|"In addition to their usual care, participants in the Interactive Voice Recognition (IVR) arm received automated phone calls, triggered by dispensing events in the electronic medical record (EMR), to educate patients about their medications and assist them in refilling their prescriptions.~The calls fell into two basic types: simple refill reminders and tardy calls for those who were overdue for a refill. Calls occured monthly and were triggered by dispensing information in the EMR. Call features included the ability to transfer individuals to Kaiser's automated prescription refill service as well as to care managers. Although the calls were triggered by and focused on use of ACE inhibitors, ARBs and statins, they also included reminders to use aspirin, which is known to also be effective for secondary prevention in this patient population."
298308|NCT01251757|P1|Participant Flow|Usual Care (UC)|Participants in this arm had full access to all care they were normally entitled to as part of usual care
298309|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|statin users in IVR+ arm
298310|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|statin users in IVR arm
298311|NCT01251757|O1|Outcome|Usual Care (UC)|statin users in UC arm
298312|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|statin users in IVR+ arm
298313|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|statin users in IVR arm
298314|NCT01251757|O1|Outcome|Usual Care (UC)|statin users in UC arm
298315|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|ACEI/ARB users in IVR+ arm
298316|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|ACEI/ARB users in IVR arm .
298317|NCT01251757|O1|Outcome|Usual Care (UC)|ACEI/ARB users in UC arm
298318|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|ACEI/ARB users in IVR+ arm
298319|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|ACEI/ARB users in IVR arm .
298320|NCT01251757|O1|Outcome|Usual Care (UC)|ACEI/ARB users in UC arm
298321|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|ACEI/ARB users in IVR+ arm
298322|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|ACEI/ARB users in IVR arm
298323|NCT01251757|O1|Outcome|Usual Care (UC)|ACEI/ARB users in UC arm
298324|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|statin users in IVR+ arm
298325|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|statin users in IVR arm
298326|NCT01251757|O1|Outcome|Usual Care (UC)|statin users in UC arm
298327|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|ACEI/ARB users in IVR+ arm
298328|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|ACEI/ARB users in IVR arm
298329|NCT01251757|O1|Outcome|Usual Care (UC)|ACEI/ARB users in UC arm
298330|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|statin users in IVR+ arm
298331|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|statin users in IVR arm
298332|NCT01251757|O1|Outcome|Usual Care (UC)|statin users in UC arm
298333|NCT01251757|E3|Reported Event|Enhanced IVR (IVR+)|usual care plus automated phone calls plus educational mailings and mail follow-up for persistent nonadherence
298334|NCT01251757|E2|Reported Event|Interactive Voice Recognition (IVR)|usual care plus automated phone calls
298335|NCT01251757|E1|Reported Event|Usual Care (UC)|usual medical care
298336|NCT01251653|B10|Baseline|Total|Total of all reporting groups
298337|NCT01251653|B9|Baseline|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298338|NCT01251653|B8|Baseline|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298339|NCT01251653|B7|Baseline|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298664|NCT01251315|B2|Baseline|N Acetyl Cysteine-A|N Acetyl cysteine low dose group (600mg oral X1)
298665|NCT01251315|B1|Baseline|Placebo-A|low dose oral x1
298340|NCT01251653|B6|Baseline|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
298341|NCT01251653|B5|Baseline|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298342|NCT01251653|B4|Baseline|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298343|NCT01251653|B3|Baseline|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298344|NCT01251653|B2|Baseline|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298345|NCT01251653|B1|Baseline|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298346|NCT01251653|P9|Participant Flow|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298347|NCT01251653|P8|Participant Flow|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298348|NCT01251653|P7|Participant Flow|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298349|NCT01251653|P6|Participant Flow|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
298350|NCT01251653|P5|Participant Flow|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298351|NCT01251653|P4|Participant Flow|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298352|NCT01251653|P3|Participant Flow|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298353|NCT01251653|P2|Participant Flow|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298354|NCT01251653|P1|Participant Flow|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298355|NCT01251653|O4|Outcome|Docetaxel 75mg Without Afatinib|Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298356|NCT01251653|O3|Outcome|Docetaxel 75mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298357|NCT01251653|O2|Outcome|Docetaxel 60mg Without Afatinib|Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298358|NCT01251653|O1|Outcome|Docetaxel 60mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298359|NCT01251653|O4|Outcome|Docetaxel 75mg Without Afatinib|Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298360|NCT01251653|O3|Outcome|Docetaxel 75mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298361|NCT01251653|O2|Outcome|Docetaxel 60mg Without Afatinib|Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298362|NCT01251653|O1|Outcome|Docetaxel 60mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298363|NCT01251653|O4|Outcome|Docetaxel 75mg Without Afatinib|Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298364|NCT01251653|O3|Outcome|Docetaxel 75mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298365|NCT01251653|O2|Outcome|Docetaxel 60mg Without Afatinib|Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298366|NCT01251653|O1|Outcome|Docetaxel 60mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298367|NCT01251653|O4|Outcome|Docetaxel 75mg Without Afatinib|Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298368|NCT01251653|O3|Outcome|Docetaxel 75mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298369|NCT01251653|O2|Outcome|Docetaxel 60mg Without Afatinib|Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298370|NCT01251653|O1|Outcome|Docetaxel 60mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298371|NCT01251653|O2|Outcome|Gemcitabine 1000mg Without Afatinib|Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298372|NCT01251653|O1|Outcome|Gemcitabine 1000mg With Afatinib 40 mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298373|NCT01251653|O2|Outcome|Gemcitabine 1000mg Without Afatinib|Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298374|NCT01251653|O1|Outcome|Gemcitabine 1000mg With Afatinib 40 mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298375|NCT01251653|O2|Outcome|Gemcitabine 1000mg Without Afatinib|Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298376|NCT01251653|O1|Outcome|Gemcitabine 1000mg With Afatinib 40 mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298377|NCT01251653|O2|Outcome|Gemcitabine 1000mg Without Afatinib|Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298378|NCT01251653|O1|Outcome|Gemcitabine 1000mg With Afatinib 40 mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298379|NCT01251653|O6|Outcome|Afatinib 30mg Without Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in 3- week treatment course.
298380|NCT01251653|O5|Outcome|Afatinib 30mg With Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298381|NCT01251653|O4|Outcome|Afatinib 30mg Without Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in 3- week treatment course.
298382|NCT01251653|O3|Outcome|Afatinib 30mg With Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298383|NCT01251653|O2|Outcome|Afatinib 40mg Without Gemcitabine|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in 3- week treatment course.
298384|NCT01251653|O1|Outcome|Afatinib 40mg With Gemcitabine 1000 mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298385|NCT01251653|O6|Outcome|Afatinib 30mg Without Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in 3- week treatment course.
298386|NCT01251653|O5|Outcome|Afatinib 30mg With Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298387|NCT01251653|O4|Outcome|Afatinib 30mg Without Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in 3- week treatment course.
298388|NCT01251653|O3|Outcome|Afatinib 30mg With Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
298389|NCT01251653|O2|Outcome|Afatinib 40mg Without Gemcitabine|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in 3- week treatment course.
298390|NCT01251653|O1|Outcome|Afatinib 40mg With Gemcitabine 1000 mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298391|NCT01251653|O3|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298392|NCT01251653|O2|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
298393|NCT01251653|O1|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298394|NCT01251653|O3|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298395|NCT01251653|O2|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
298396|NCT01251653|O1|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298397|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298398|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298399|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
299142|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
298400|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
298401|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298402|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298403|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298404|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298405|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298406|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298407|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298408|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298409|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
298410|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298411|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298412|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298413|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298414|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298415|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298416|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298417|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298418|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
298419|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298420|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298421|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298422|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298423|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298424|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298425|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298426|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298427|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
298428|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298429|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298430|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298431|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298432|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298433|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298434|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298435|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298436|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
298437|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298438|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298439|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298440|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298441|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298442|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298443|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298444|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298445|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
298446|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298447|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298448|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298449|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298450|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298451|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298452|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298453|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298454|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
298455|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298456|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298457|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298458|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298459|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298460|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298461|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298462|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298463|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
298464|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298465|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298466|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298467|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298468|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298469|NCT01251653|E9|Reported Event|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298470|NCT01251653|E8|Reported Event|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298471|NCT01251653|E7|Reported Event|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298472|NCT01251653|E6|Reported Event|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
298473|NCT01251653|E5|Reported Event|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298474|NCT01251653|E4|Reported Event|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298475|NCT01251653|E3|Reported Event|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298476|NCT01251653|E2|Reported Event|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298477|NCT01251653|E1|Reported Event|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
298478|NCT01251614|B4|Baseline|Total|Total of all reporting groups
298537|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
298538|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1.
298479|NCT01251614|B3|Baseline|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298480|NCT01251614|B2|Baseline|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
298481|NCT01251614|B1|Baseline|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298482|NCT01251614|P3|Participant Flow|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298483|NCT01251614|P2|Participant Flow|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
298484|NCT01251614|P1|Participant Flow|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298485|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298539|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
298547|NCT01251614|E8|Reported Event|Period C: Adalimumab 0.8 mg/kg|Participants initially randomized to either methotrexate or adalimumab 0.8 mg/kg with loss of disease control in Period B received adalimumab 0.8 mg/kg eow for up to 16 weeks in Period C.
298486|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
298487|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298488|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298489|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
298490|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298491|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
298492|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
298493|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1.
298494|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298540|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
298548|NCT01251614|E7|Reported Event|Period C: Adalimumab 0.4 mg/kg|Participants initially randomized to adalimumab 0.4 mg/kg with loss of disease control in Period B received adalimumab 0.4 mg/kg eow for up to 16 weeks in Period C.
298495|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
298496|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298497|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298498|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
298499|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298500|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298501|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
298541|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1.
298549|NCT01251614|E6|Reported Event|Period B: ADA 0.8 mg/kg/No Treatment|Participants initially randomized to adalimumab (ADA) 0.8 mg/kg who responded in Period A were withdrawn from active therapy in Period B for up to 36 weeks.
298502|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298503|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298504|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
298505|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298506|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298507|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
298508|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298542|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
298550|NCT01251614|E5|Reported Event|Period B: ADA 0.4 mg/kg/No Treatment|Participants initially randomized to adalimumab (ADA) 0.4 mg/kg who responded in Period A were withdrawn from active therapy in Period B for up to 36 weeks.
298509|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298510|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
298511|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298512|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298513|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
298514|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298515|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298543|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
298551|NCT01251614|E4|Reported Event|Period B: MTX/No Treatment|Participants initially randomized to methotrexate who responded in Period A were withdrawn from active therapy in Period B for up to 36 weeks.
298516|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
298517|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298518|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298519|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
298520|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298521|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298522|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
298544|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1.
298545|NCT01251614|E10|Reported Event|Period D: Adalimumab 0.8 mg/kg|Participants received adalimumab 0.8 mg/kg eow for up to 52 weeks in Period D.
299213|NCT01250002|B2|Baseline|Placebo|Group B (control group) will receive the same volume of saline infusion.
298523|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298524|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298525|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
298526|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
298527|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
298528|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
298529|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1.
298530|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
298531|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
298532|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1.
298533|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
298534|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
298535|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1.
298536|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
298546|NCT01251614|E9|Reported Event|Period D: Adalimumab 0.4 mg/kg|Participants received adalimumab 0.4 mg/kg eow for up to 52 weeks in Period D.
298552|NCT01251614|E3|Reported Event|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
298553|NCT01251614|E2|Reported Event|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
298554|NCT01251614|E1|Reported Event|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1.
298555|NCT01251588|B3|Baseline|Total|Total of all reporting groups
298556|NCT01251588|B2|Baseline|Microfracture|Microfracture: Arthroscopic Microfracture
298557|NCT01251588|B1|Baseline|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
298558|NCT01251588|P2|Participant Flow|Microfracture|Microfracture: Arthroscopic Microfracture
298559|NCT01251588|P1|Participant Flow|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
298560|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
298561|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
298562|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
298563|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
298564|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
298565|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
298566|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
298567|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
298568|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
298569|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
298570|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
298571|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
298572|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
298573|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
298574|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
298575|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
298576|NCT01251588|O2|Outcome|Microfracture|"Microfracture treatment received in previous MACI00206 study~Microfracture: Arthroscopic Microfracture treatment received in the previous MACI00206 study"
298577|NCT01251588|O1|Outcome|MACI|"autologous cultured chondrocytes on porcine collagen membrane implant received in previous MACI00206 study~autologous cultured chondrocytes on porcine collagen membrane: Implantation received in the previous MACI00206 study"
298578|NCT01251588|O2|Outcome|Microfracture|"Microfracture treatment received in previous MACI00206 study~Microfracture: Arthroscopic Microfracture treatment received in the previous MACI00206 study"
298579|NCT01251588|O1|Outcome|MACI|"autologous cultured chondrocytes on porcine collagen membrane implant received in previous MACI00206 study~autologous cultured chondrocytes on porcine collagen membrane: Implantation received in the previous MACI00206 study"
298580|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
298581|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
298582|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
298583|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
298584|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
298585|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
298586|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
298587|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
298588|NCT01251588|E2|Reported Event|Microfracture|Microfracture: Arthroscopic Microfracture
298589|NCT01251588|E1|Reported Event|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
298590|NCT01251380|B1|Baseline|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
298591|NCT01251380|P1|Participant Flow|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
298592|NCT01251380|O3|Outcome|Dysport Treatment Cycle 3|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
298593|NCT01251380|O2|Outcome|Dysport Treatment Cycle 2|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
298594|NCT01251380|O1|Outcome|Dysport Treatment Cycle 1|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
298595|NCT01251380|O3|Outcome|Dysport Treatment Cycle 3|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
298596|NCT01251380|O2|Outcome|Dysport Treatment Cycle 2|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
298650|NCT01251354|P1|Participant Flow|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
298597|NCT01251380|O1|Outcome|Dysport Treatment Cycle 1|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
298598|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
298599|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
298600|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
298601|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
298602|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
298603|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
298604|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
298605|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5U/kg to 20U/kg for one leg and 10U/kg to 30U/kg for both legs
298606|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
298607|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
298608|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
298609|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
298610|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
298611|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
298612|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs.
298613|NCT01251380|E1|Reported Event|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs.
298614|NCT01251367|B1|Baseline|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298615|NCT01251367|P1|Participant Flow|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 Units [U] or 1000 U) by intramuscular (i.m.) injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298616|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298651|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
298652|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
298653|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
298654|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
298655|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
298617|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298618|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298619|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298620|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298621|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298622|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298623|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298624|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298656|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
298625|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298626|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298627|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298628|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298629|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298630|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298631|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298632|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298657|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
298633|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298634|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298635|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298636|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298637|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298638|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298639|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298640|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298658|NCT01251354|E1|Reported Event|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
298659|NCT01251315|B7|Baseline|Total|Total of all reporting groups
298641|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298642|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298643|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298644|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298645|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298646|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298647|NCT01251367|O1|Outcome|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298648|NCT01251367|E1|Reported Event|Total Dysport®|Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
298649|NCT01251354|B1|Baseline|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
298666|NCT01251315|P6|Participant Flow|Proimmune 200 (High Dose, 6000 mg Oral as a Single Dose)|Proimmune 200 (high dose, 6000 mg oral as a single dose)
298667|NCT01251315|P5|Participant Flow|N Acetyl Cysteine (High Dose, 1200 mg Oral as a Single Dose)|N Acetyl cysteine (high dose 1200 mg oral as a single dose)
298668|NCT01251315|P4|Participant Flow|Placebo High Dose Group, Given Oral as a Single Dose|Placebo high dose group, given oral as a single dose
298669|NCT01251315|P3|Participant Flow|Proimmune 200 (Low Dose, 3000 mg Oral as a Single Dose)|Proimmune 200 (low dose, 3000 mg oral as a single dose)
298670|NCT01251315|P2|Participant Flow|N Acetyl Cysteine (Low Dose, 600mg Oral as a Single Dose)|N Acetyl cysteine (low dose, 600mg oral as a single dose)
298671|NCT01251315|P1|Participant Flow|Placebo Low Dose Group, Given Oral as a Single Dose|Placebo low dose group, given oral as a single dose
298672|NCT01251315|O6|Outcome|Proimmune 200-B|Proimmune 200 High dose group
298673|NCT01251315|O5|Outcome|N Acetyl Cysteine-B|N Acetyl Cysteine High dose group
298674|NCT01251315|O4|Outcome|Placebo-B|Placebo High dose group
298675|NCT01251315|O3|Outcome|Proimmune 200-A|Proimmune 200 low dose group
298676|NCT01251315|O2|Outcome|N Acetyl Cysteine-A|N Acetyl cysteine low dose group
298677|NCT01251315|O1|Outcome|Placebo-A|Placebo low dose group
298678|NCT01251315|O6|Outcome|Proimmune 200-B|Proimmune 200 High dose group (6000mg oral x1)
298679|NCT01251315|O5|Outcome|N Acetyl Cysteine-B|N Acetyl Cysteine High dose group (1200 mg oral x1)
298680|NCT01251315|O4|Outcome|Placebo-B|Placebo High dose group
298681|NCT01251315|O3|Outcome|Proimmune 200-A|Proimmune 200 low dose group ( 3000mg oral x1)
298682|NCT01251315|O2|Outcome|N Acetyl Cysteine-A|N Acetyl cysteine low dose group ( 600mg oral x1)
298683|NCT01251315|O1|Outcome|Placebo-A|Placebo low dose group
298684|NCT01251315|E6|Reported Event|Proimmune 200-B|Proimmune 200 High dose group
298685|NCT01251315|E5|Reported Event|N Acetyl Cysteine-B|N Acetyl Cysteine High dose group
298686|NCT01251315|E4|Reported Event|Placebo-B|High dose group
298687|NCT01251315|E3|Reported Event|Proimmune 200-A|Proimmune 200 low dose group
298688|NCT01251315|E2|Reported Event|N Acetyl Cysteine-A|N Acetyl cysteine low dose group
298689|NCT01251315|E1|Reported Event|Placebo-A|low dose group
298690|NCT01251276|B3|Baseline|Total|Total of all reporting groups
298691|NCT01251276|B2|Baseline|ENGERIX-B™ Vaccine in Base Study|Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
298692|NCT01251276|B1|Baseline|Modified Process Hepatitis B Vaccine in Base Study|Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
298693|NCT01251276|P2|Participant Flow|ENGERIX-B™ Vaccine in Base Study|Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
298694|NCT01251276|P1|Participant Flow|Modified Process Hepatitis B Vaccine in Base Study|Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
298695|NCT01251276|O2|Outcome|ENGERIX-B™ Vaccine in Base Study|Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
298696|NCT01251276|O1|Outcome|Modified Process Hepatitis B Vaccine in Base Study|Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
298697|NCT01251276|O2|Outcome|ENGERIX-B™ Vaccine in Base Study|Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
298698|NCT01251276|O1|Outcome|Modified Process Hepatitis B Vaccine in Base Study|Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
298699|NCT01251276|O2|Outcome|ENGERIX-B™ Vaccine in Base Study|Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
298700|NCT01251276|O1|Outcome|Modified Process Hepatitis B Vaccine in Base Study|Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
298701|NCT01251276|O2|Outcome|ENGERIX-B™ Vaccine in Base Study|Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
298702|NCT01251276|O1|Outcome|Modified Process Hepatitis B Vaccine in Base Study|Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
298703|NCT01251276|O2|Outcome|ENGERIX-B™ Vaccine in Base Study|Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
298704|NCT01251276|O1|Outcome|Modified Process Hepatitis B Vaccine in Base Study|Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
298705|NCT01251276|O2|Outcome|ENGERIX-B™ Vaccine in Base Study|Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
298706|NCT01251276|O1|Outcome|Modified Process Hepatitis B Vaccine in Base Study|Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
298827|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298707|NCT01251276|E2|Reported Event|ENGERIX-B™ Vaccine in Base Study|Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
298708|NCT01251276|E1|Reported Event|Modified Process Hepatitis B Vaccine in Base Study|Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
298709|NCT01251146|B3|Baseline|Total|Total of all reporting groups
298710|NCT01251146|B2|Baseline|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
298711|NCT01251146|B1|Baseline|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
298712|NCT01251146|P2|Participant Flow|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
298713|NCT01251146|P1|Participant Flow|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
298714|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
298715|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
298716|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
298717|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
300046|NCT01247350|O2|Outcome|14 mg LY3009104 Day 1|14 mg administered orally on Day 1
298718|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
298719|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
298720|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
298721|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
298722|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
298723|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
298724|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
298725|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
298742|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
298743|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
298744|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
298726|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
298727|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
298728|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
298729|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
298730|NCT01251146|E2|Reported Event|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
298731|NCT01251146|E1|Reported Event|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
298732|NCT01251120|B3|Baseline|Total|Total of all reporting groups
298733|NCT01251120|B2|Baseline|Placebo|Participants received Non-biologic DMARDs (including methotrexate) according to current best practice
298734|NCT01251120|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks plus background DMARDs (including methotrexate)
298735|NCT01251120|P2|Participant Flow|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
298736|NCT01251120|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenously every 4 weeks along with background disease-modifying antirheumatic drugs (DMARDs) including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
298737|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
298738|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
298739|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
298740|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
298741|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
300047|NCT01247350|O1|Outcome|10 mg LY3009104 Day 1|10 mg administered orally on Day 1
298745|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
298746|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
298747|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
298748|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
298749|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
298750|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
298751|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
298752|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
298753|NCT01251120|E2|Reported Event|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
298754|NCT01251120|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
298755|NCT01251042|B3|Baseline|Total|Total of all reporting groups
298756|NCT01251042|B2|Baseline|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
298757|NCT01251042|B1|Baseline|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
298758|NCT01251042|P2|Participant Flow|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
298759|NCT01251042|P1|Participant Flow|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
298760|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
298761|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
298762|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
298763|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
298764|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
298765|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
298766|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
298767|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
298768|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
298769|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
298770|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
298771|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
298772|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
298773|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
298774|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
298775|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
298776|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
298777|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
298778|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
298779|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
298780|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
298781|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
298782|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
298783|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
298784|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
298785|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
298786|NCT01251042|E2|Reported Event|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
298787|NCT01251042|E1|Reported Event|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
298788|NCT01250990|B3|Baseline|Total|Total of all reporting groups
298789|NCT01250990|B2|Baseline|Placebo|"Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that.~Placebo: Placebo"
298826|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298790|NCT01250990|B1|Baseline|Niacin|"Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.~Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated."
298791|NCT01250990|P2|Participant Flow|Placebo|"Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that.~Placebo: Placebo"
298792|NCT01250990|P1|Participant Flow|Niacin|"Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.~Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated."
298793|NCT01250990|O2|Outcome|Placebo|"Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that.~Placebo: Placebo"
298794|NCT01250990|O1|Outcome|Niacin|"Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.~Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated."
298795|NCT01250990|E2|Reported Event|Placebo|"Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that.~Placebo: Placebo"
298796|NCT01250990|E1|Reported Event|Niacin|"Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.~Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated."
298797|NCT01250925|B4|Baseline|Total|Total of all reporting groups
298798|NCT01250925|B3|Baseline|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298799|NCT01250925|B2|Baseline|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298800|NCT01250925|B1|Baseline|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298801|NCT01250925|P3|Participant Flow|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298802|NCT01250925|P2|Participant Flow|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298803|NCT01250925|P1|Participant Flow|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298804|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298805|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298806|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298807|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298808|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298809|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298810|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298811|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298812|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298813|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298814|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298815|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298816|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298817|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298818|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298819|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298820|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298821|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298822|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298823|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298824|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298825|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298828|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298829|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298830|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298831|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298832|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298833|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298834|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298835|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298836|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298837|NCT01250925|E3|Reported Event|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298838|NCT01250925|E2|Reported Event|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298839|NCT01250925|E1|Reported Event|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
298840|NCT01250899|B3|Baseline|Total|Total of all reporting groups
298841|NCT01250899|B2|Baseline|Vitamin D Insufficient|HIV-infected men and women on stable ART with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D <30ng/mL received open-label, oral vitamin D3 50,000 IU twice weekly for 5 weeks, then 2000 IU daily to complete 12 weeks.
298842|NCT01250899|B1|Baseline|Vitamin D Sufficient|HIV-infected men and women on stable ART with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D ≥30ng/mL had a baseline visit only, and did not receive vitamin D supplementation.
298843|NCT01250899|P2|Participant Flow|Vitamin D Insufficient|HIV-infected men and women on stable ART underwent routine serum 25(OH)D screening. Persons with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D <30ng/mL received open-label, oral vitamin D3 50,000 IU twice weekly for 5 weeks, then 2000 IU daily to complete 12 weeks. Serum 25(OH)D levels were measured at baseline, 12 weeks and 24 weeks.
298844|NCT01250899|P1|Participant Flow|Vitamin D Sufficient|HIV-infected men and women on stable ART underwent routine serum 25(OH)D screening. Persons with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D ≥30ng/mL had a baseline visit only, and did not receive vitamin D supplementation.
298845|NCT01250899|O1|Outcome|Vitamin D Insufficient|Baseline 25(OH)D <30 ng/mL received 12 weeks of oral vitamin D supplementation. Serum 25(OH)D levels were measured at baseline, 12 weeks and 24 weeks.
298846|NCT01250899|E1|Reported Event|Vitamin D Insufficient|25(OH)D <30 mg/mL at study entry (i.e. group of patients receiving vitamin D supplementation).
298847|NCT01250834|B1|Baseline|LY2189265 + Atorvastatin|"Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.~Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3."
298848|NCT01250834|P1|Participant Flow|LY2189265 + Atorvastatin|"Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.~Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3."
298849|NCT01250834|O2|Outcome|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
298850|NCT01250834|O1|Outcome|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
298851|NCT01250834|O2|Outcome|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
298852|NCT01250834|O1|Outcome|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
298853|NCT01250834|O2|Outcome|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
298854|NCT01250834|O1|Outcome|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
298855|NCT01250834|O2|Outcome|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
298856|NCT01250834|O1|Outcome|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
298857|NCT01250834|O2|Outcome|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
298858|NCT01250834|O1|Outcome|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
298859|NCT01250834|O2|Outcome|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
298860|NCT01250834|O1|Outcome|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
298861|NCT01250834|E3|Reported Event|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3. The time period for this arm was after the atorvastatin dose on Day 3 in Period 2.
298862|NCT01250834|E2|Reported Event|1.5 mg LY2189265|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3. The time period for this arm was from Day 1 to predose of atorvastatin on Day 3.
298863|NCT01250834|E1|Reported Event|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
298864|NCT01250769|B5|Baseline|Total|Total of all reporting groups
298865|NCT01250769|B4|Baseline|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
298866|NCT01250769|B3|Baseline|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
298867|NCT01250769|B2|Baseline|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
298868|NCT01250769|B1|Baseline|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
298869|NCT01250769|P4|Participant Flow|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
298870|NCT01250769|P3|Participant Flow|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
298871|NCT01250769|P2|Participant Flow|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
298872|NCT01250769|P1|Participant Flow|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
298873|NCT01250769|O4|Outcome|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
298874|NCT01250769|O3|Outcome|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
298875|NCT01250769|O2|Outcome|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
298876|NCT01250769|O1|Outcome|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
298877|NCT01250769|O4|Outcome|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
298878|NCT01250769|O3|Outcome|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
298879|NCT01250769|O2|Outcome|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
298880|NCT01250769|O1|Outcome|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
298881|NCT01250769|O4|Outcome|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
298882|NCT01250769|O3|Outcome|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
298883|NCT01250769|O2|Outcome|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
298884|NCT01250769|O1|Outcome|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
298885|NCT01250769|O4|Outcome|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
298886|NCT01250769|O3|Outcome|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
298887|NCT01250769|O2|Outcome|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
298888|NCT01250769|O1|Outcome|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
298889|NCT01250769|O4|Outcome|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
298890|NCT01250769|O3|Outcome|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
298891|NCT01250769|O2|Outcome|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
298892|NCT01250769|O1|Outcome|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
298893|NCT01250769|O4|Outcome|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
298894|NCT01250769|O3|Outcome|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
298895|NCT01250769|O2|Outcome|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
298896|NCT01250769|O1|Outcome|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
298897|NCT01250769|E4|Reported Event|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
298898|NCT01250769|E3|Reported Event|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
298899|NCT01250769|E2|Reported Event|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
298900|NCT01250769|E1|Reported Event|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
298901|NCT01250756|B3|Baseline|Total|Total of all reporting groups
298902|NCT01250756|B2|Baseline|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
300100|NCT01247324|B3|Baseline|Total|Total of all reporting groups
298903|NCT01250756|B1|Baseline|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
298904|NCT01250756|P2|Participant Flow|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
298905|NCT01250756|P1|Participant Flow|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
298906|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
298907|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
298908|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
298909|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
298910|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
298911|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
298912|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
298913|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
298914|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
298915|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
298974|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
298975|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
298916|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
298917|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
298918|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
298919|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
298920|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
298921|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
298922|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
298923|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
298924|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
298925|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
298926|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
298927|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
298928|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
298976|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
298977|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
299214|NCT01250002|B1|Baseline|Group A (Study Group) Lidocaine|Group A (study group) Lidocaine administration
298929|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
298930|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
298931|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
298932|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
298933|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
298934|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
298935|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
298936|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
298937|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
298938|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
298939|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
298940|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
298941|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
298942|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
298943|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
298944|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
298945|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
298946|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
298947|NCT01250756|E7|Reported Event|DTaP (Catch-up 7vPnC) - After the Toddler Dose|Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed after the CU Dose 3 to 28 to 42 days post-CU Dose 3.
298948|NCT01250756|E6|Reported Event|DTaP (Catch-up 7vPnC) - Toddler Dose|Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed from toddler dose through the CU Dose 3.
298949|NCT01250756|E5|Reported Event|7vPnC + DTaP - Toddler Dose|Participants who received a single 0.5 mL dose of 7vPnC subcutaneously (toddler dose) along with 0.5 mL dose of DTaP subcutaneously, assessed from the toddler dose through the blood draw 28 to 42 days post-toddler dose.
298950|NCT01250756|E4|Reported Event|DTaP (Catch-up 7vPnC) - After the Infant Series|Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed after CU Dose 1 to the toddler dose.
298951|NCT01250756|E3|Reported Event|7vPnC + DTaP - After the Infant Series|Participants who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed after the infant series blood draw to the toddler dose.
298952|NCT01250756|E2|Reported Event|DTaP (Catch-up 7vPnC)- Infant Series|Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed from Infant Dose 1 through the CU Dose 1.
298953|NCT01250756|E1|Reported Event|7vPnC + DTaP - Infant Series|Participants who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed from Infant Dose 1 through the blood draw 28 to 42 days post-infant series.
298954|NCT01250730|B4|Baseline|Total|Total of all reporting groups
298955|NCT01250730|B3|Baseline|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
298956|NCT01250730|B2|Baseline|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
298957|NCT01250730|B1|Baseline|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
298958|NCT01250730|P3|Participant Flow|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
298959|NCT01250730|P2|Participant Flow|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
298960|NCT01250730|P1|Participant Flow|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
298961|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
298962|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
298963|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
298964|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
298965|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
298966|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
298967|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
298968|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
298969|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
298970|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
298971|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
298972|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
298973|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
298978|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
298979|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
298980|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
298981|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
298982|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
298983|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
298984|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
298985|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
298986|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
298987|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
298988|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
298989|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
298990|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
298991|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
298992|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
298993|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
298994|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
298995|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
298996|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
298997|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
298998|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
298999|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
299000|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
299001|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
299002|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
299003|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
299004|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
299005|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
299006|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
299007|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
299008|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
299009|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
299010|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
299011|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
299012|NCT01250730|E3|Reported Event|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
299013|NCT01250730|E2|Reported Event|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
299014|NCT01250730|E1|Reported Event|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
299015|NCT01250717|B1|Baseline|Docetaxel Followed by Radical Prostatectomy|"This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below.~Docetaxel Followed by Radical Prostatectomy~Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy~Zoladex : Given subcutaneously for 4 doses every three months~Casodex : Taken orally once a day for 6 months~Estramustine : Taken orally three times a day for 5 days for the first part of every three week cycle~Docetaxel : Given by an IV infusion over 1 hour on day 2 of a three-week cycle~Dexamethasone : Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel"
299016|NCT01250717|P1|Participant Flow|Docetaxel Followed by Radical Prostatectomy|"This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below.~Docetaxel Followed by Radical Prostatectomy~Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy~Zoladex : Given subcutaneously for 4 doses every three months~Casodex : Taken orally once a day for 6 months~Estramustine : Taken orally three times a day for 5 days for the first part of every three week cycle~Docetaxel : Given by an IV infusion over 1 hour on day 2 of a three-week cycle~Dexamethasone : Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel"
299126|NCT01250184|O3|Outcome|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
299143|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
299017|NCT01250717|O1|Outcome|Docetaxel Followed by Radical Prostatectomy|"This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below.~Docetaxel Followed by Radical Prostatectomy~Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy~Zoladex : Given subcutaneously for 4 doses every three months~Casodex : Taken orally once a day for 6 months~Estramustine : Taken orally three times a day for 5 days for the first part of every three week cycle~Docetaxel : Given by an IV infusion over 1 hour on day 2 of a three-week cycle~Dexamethasone : Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel"
299018|NCT01250717|E1|Reported Event|Docetaxel Followed by Radical Prostatectomy|"This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below.~Docetaxel Followed by Radical Prostatectomy~Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy~Zoladex : Given subcutaneously for 4 doses every three months~Casodex : Taken orally once a day for 6 months~Estramustine : Taken orally three times a day for 5 days for the first part of every three week cycle~Docetaxel : Given by an IV infusion over 1 hour on day 2 of a three-week cycle~Dexamethasone : Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel"
299019|NCT01250509|B3|Baseline|Total|Total of all reporting groups
299020|NCT01250509|B2|Baseline|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
299021|NCT01250509|B1|Baseline|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
299022|NCT01250509|P2|Participant Flow|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
299023|NCT01250509|P1|Participant Flow|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
299024|NCT01250509|O2|Outcome|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
299025|NCT01250509|O1|Outcome|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
299026|NCT01250509|O2|Outcome|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
299027|NCT01250509|O1|Outcome|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
299028|NCT01250509|O2|Outcome|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
299029|NCT01250509|O1|Outcome|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
299030|NCT01250509|O2|Outcome|Waitlist|
299031|NCT01250509|O1|Outcome|CALMM|
299032|NCT01250509|E2|Reported Event|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
299033|NCT01250509|E1|Reported Event|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
299034|NCT01250418|B3|Baseline|Total|Total of all reporting groups
299035|NCT01250418|B2|Baseline|No Ketamine|No ketamine added to anesthesia regimen
299036|NCT01250418|B1|Baseline|Ketamine Group|"ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.~Ketamine group: ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min."
299037|NCT01250418|P2|Participant Flow|No Ketamine|No ketamine added to anesthesia regimen
299038|NCT01250418|P1|Participant Flow|Ketamine Group|ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
299039|NCT01250418|O2|Outcome|No Ketamine|No ketamine added to anesthesia regimen
299040|NCT01250418|O1|Outcome|Ketamine Group|"ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.~Ketamine group: ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min."
299041|NCT01250418|E2|Reported Event|Ketamine Group|Ketamine group: Ketamine group: ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
299042|NCT01250418|E1|Reported Event|No Ketamine Added to Anesthesia Regimen|No ketamine added to the patients anesthesia regimen
299043|NCT01250379|B3|Baseline|Total|Total of all reporting groups
299044|NCT01250379|B2|Baseline|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299045|NCT01250379|B1|Baseline|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299127|NCT01250184|O2|Outcome|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
299128|NCT01250184|O1|Outcome|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
299144|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
299046|NCT01250379|P2|Participant Flow|Chemotherapy Plus Bevacizumab (CT+BV) Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 milligrams per kilogram (mg/kg), intravenously (IV), every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299047|NCT01250379|P1|Participant Flow|Chemotherapy (CT) Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299048|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299049|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299050|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299051|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299052|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299053|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299129|NCT01250184|E3|Reported Event|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
300204|NCT01247090|E2|Reported Event|Low Dose|Low Dose: Active Comparator 0.30 mU per kg per minute
299054|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299055|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299056|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299057|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299058|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299059|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299060|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299061|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299130|NCT01250184|E2|Reported Event|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
299145|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
299146|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
299062|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299063|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299064|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299065|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299066|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299067|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299068|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299069|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299131|NCT01250184|E1|Reported Event|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
299070|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299071|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299072|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299073|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299074|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299075|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299076|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299077|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299132|NCT01250171|B4|Baseline|Total|Total of all reporting groups
299133|NCT01250171|B3|Baseline|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
299134|NCT01250171|B2|Baseline|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
299078|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299079|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299080|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299081|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299082|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299083|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299084|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299085|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299135|NCT01250171|B1|Baseline|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
299136|NCT01250171|P3|Participant Flow|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
299215|NCT01250002|P2|Participant Flow|Placebo|Group B (control group) will receive the same volume of saline infusion.
299086|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299087|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299088|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299089|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299090|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299091|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299092|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299093|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299137|NCT01250171|P2|Participant Flow|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
299138|NCT01250171|P1|Participant Flow|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
301470|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
299094|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299095|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299096|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299097|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299098|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299099|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299100|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299101|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299139|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
299140|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
299141|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
299102|NCT01250379|E2|Reported Event|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299103|NCT01250379|E1|Reported Event|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
299104|NCT01250184|B4|Baseline|Total|Total of all reporting groups
299105|NCT01250184|B3|Baseline|Blocking the MTP|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
299106|NCT01250184|B2|Baseline|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
299107|NCT01250184|B1|Baseline|Blocking the MTP Plus Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
299108|NCT01250184|P3|Participant Flow|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
299109|NCT01250184|P2|Participant Flow|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
299110|NCT01250184|P1|Participant Flow|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
299111|NCT01250184|O3|Outcome|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
299112|NCT01250184|O2|Outcome|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
299113|NCT01250184|O1|Outcome|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
299114|NCT01250184|O3|Outcome|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
299115|NCT01250184|O2|Outcome|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
299116|NCT01250184|O1|Outcome|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
299117|NCT01250184|O3|Outcome|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
299118|NCT01250184|O2|Outcome|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
299119|NCT01250184|O1|Outcome|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
299120|NCT01250184|O3|Outcome|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
299121|NCT01250184|O2|Outcome|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
299122|NCT01250184|O1|Outcome|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
299123|NCT01250184|O3|Outcome|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
299124|NCT01250184|O2|Outcome|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
299125|NCT01250184|O1|Outcome|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
304715|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
299147|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
299148|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
299149|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
299150|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
299151|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
299152|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
299153|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
299154|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
299155|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
299156|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
299157|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
299158|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
299159|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
299160|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
299161|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
299162|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
299163|NCT01250171|E3|Reported Event|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
299164|NCT01250171|E2|Reported Event|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
299165|NCT01250171|E1|Reported Event|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
299166|NCT01250145|B3|Baseline|Total|Total of all reporting groups
299167|NCT01250145|B2|Baseline|LY333334 + Placebo: Part B|"Part B:~Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks~Rest phase: 2 weeks with no patch application~Challenge phase: 80 microgram active patch given once for at least 6 hours"
299168|NCT01250145|B1|Baseline|LY333334 + Placebo: Part A|"Part A:~Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days"
299169|NCT01250145|P2|Participant Flow|LY333334 + Placebo: Part B|"Part B:~Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks~Rest phase: 2 weeks with no patch application~Challenge phase: 80 microgram active patch given once for at least 6 hours"
299170|NCT01250145|P1|Participant Flow|LY333334 + Placebo: Part A|"Part A:~Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days"
299171|NCT01250145|O2|Outcome|Placebo Patch|"Part B: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks.~Rest phase: 2 weeks with no patch application~Challenge phase: placebo patch given once for at least 6 hours"
299172|NCT01250145|O1|Outcome|Active Patch|"Part B: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks.~Rest phase: 2 weeks with no patch application~Challenge phase: 80 microgram active patch given once for at least 6 hours"
299173|NCT01250145|O6|Outcome|Part B: Placebo Patch - 24 Hours Post Patch Application|Part B: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores 24 hours after patch application.
299174|NCT01250145|O5|Outcome|Part B: Placebo Patch - 1 Hour Post Patch Removal|Part B: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores 1 hour after patch removal.
299175|NCT01250145|O4|Outcome|Part B: Placebo Patch - Prior to Patch Application|Part B: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores prior to patch application.
299176|NCT01250145|O3|Outcome|Part B: Active Patch - 24 Hours Post Patch Application|Part B: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores 24 hours after patch application.
299177|NCT01250145|O2|Outcome|Part B: Active Patch - 1 Hour Post Patch Removal|Part B: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores 1 hour after patch removal.
299178|NCT01250145|O1|Outcome|Part B: Active Patch - Prior to Patch Application|Part B: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores prior to patch application.
299179|NCT01250145|O2|Outcome|Placebo Patch|Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days
299180|NCT01250145|O1|Outcome|Active Patch|Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days
299181|NCT01250145|O6|Outcome|Part A: Placebo Patch - 24 Hours Post Patch Application|Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 24 hours after patch application.
299211|NCT01250054|E1|Reported Event|Lotrafilcon B|Commercially marketed, silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week.
299182|NCT01250145|O5|Outcome|Part A: Placebo Patch - 1 Hour Post Patch Removal|Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 1 hour after patch removal.
299183|NCT01250145|O4|Outcome|Part A: Placebo Patch - Prior to Patch Application|Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores prior to patch application.
299184|NCT01250145|O3|Outcome|Part A: Active Patch - 24 Hours Post Patch Application|Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 24 hours after patch application.
299185|NCT01250145|O2|Outcome|Part A: Active Patch - 1 Hour Post Patch Removal|Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 1 hour after patch removal.
299186|NCT01250145|O1|Outcome|Part A: Active Patch - Prior to Patch Application|Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores prior to patch application.
299187|NCT01250145|E2|Reported Event|LY333334 + Placebo: Part B|"Part B:~Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks~Rest phase: 2 weeks with no patch application~Challenge phase: 80 microgram active patch given once for at least 6 hours"
299188|NCT01250145|E1|Reported Event|LY333334 + Placebo: Part A|"Part A:~Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days"
299189|NCT01250119|B1|Baseline|NSCLC Group|During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletions or exon 21 (L858R) mutations.
299190|NCT01250119|P2|Participant Flow|Erlotinib 150 Milligrams Per Day (mg/Day)|During the Treatment Phase participants found to have a tumour with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until progressive disease (PD), death, unacceptable toxicity or withdrawal of consent.
299191|NCT01250119|P1|Participant Flow|Non-small-cell Lung Cancer (NSCLC) Group|During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for Epidermal Growth Factor Receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.
299192|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
299193|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
299194|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
299195|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
299196|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
299197|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
299198|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
299199|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
299200|NCT01250119|O2|Outcome|EGFR Negative|All participants who tested negative for EGFR mutations were included in this group.
299201|NCT01250119|O1|Outcome|EGFR Positive|All participants who tested positive for EGFR mutations were included in this group.
299202|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
299203|NCT01250119|O1|Outcome|NSCLC Group|During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletions or exon 21 (L858R) mutations.
299204|NCT01250119|E1|Reported Event|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
299205|NCT01250054|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects.
299206|NCT01250054|P2|Participant Flow|Comfilcon A /Lotrafilcon B|Comfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.
299207|NCT01250054|P1|Participant Flow|Lotrafilcon B / Comfilcon A|Lotrafilcon B multifocal contact lenses worn first, with comfilcon A multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.
299208|NCT01250054|O2|Outcome|Comfilcon A|Commercially marketed (Europe), silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week.
299209|NCT01250054|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week.
299210|NCT01250054|E2|Reported Event|Comfilcon A|Commercially marketed (Europe), silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week.
299212|NCT01250002|B3|Baseline|Total|Total of all reporting groups
299216|NCT01250002|P1|Participant Flow|Group A (Study Group) Lidocaine|Group A (study group) Lidocaine administration
299217|NCT01250002|O2|Outcome|Placebo|Group B (control group) will receive the same volume of saline infusion.
299218|NCT01250002|O1|Outcome|Group A (Study Group) Lidocaine|Group A (study group) Lidocaine administration
299219|NCT01250002|O2|Outcome|Placebo|Group B (control group) will receive the same volume of saline infusion.
299220|NCT01250002|O1|Outcome|Group A (Study Group) Lidocaine|Group A (study group) Lidocaine administration
299221|NCT01250002|E2|Reported Event|Placebo|Group B (control group) will receive the same volume of saline infusion.
299222|NCT01250002|E1|Reported Event|Group A (Study Group) Lidocaine|Group A (study group) Lidocaine administration
299223|NCT01249872|B7|Baseline|Total|Total of all reporting groups
299224|NCT01249872|B6|Baseline|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive an epidural bolus dose of 2 mg of morphine intra-operatively (45 min before the estimated end of the surgery).Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299225|NCT01249872|B5|Baseline|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively(45 min before the estimated end of the surgery) an epidural bolus dose of 1mg of morphine. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299226|NCT01249872|B4|Baseline|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) an epidural bolus dose of 2 ml of normal saline. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299227|NCT01249872|B3|Baseline|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intraoperatively (45 min before the estimated end of the surgery) an epidural bolus dose 2 mg of morphine. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299228|NCT01249872|B2|Baseline|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16) receive intraoperatively(45 min before the estimated end of the surgery) an epidural bolus dose of 1mg of morphine.Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299229|NCT01249872|B1|Baseline|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299230|NCT01249872|P6|Participant Flow|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299231|NCT01249872|P5|Participant Flow|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299232|NCT01249872|P4|Participant Flow|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299233|NCT01249872|P3|Participant Flow|GROUP C : 2 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299234|NCT01249872|P2|Participant Flow|GROUP B : 1 mg MORPHINE- 0.1%LEVOBUPIVACAINE|Group B patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299235|NCT01249872|P1|Participant Flow|GROUP A : 0 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299236|NCT01249872|O6|Outcome|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299237|NCT01249872|O5|Outcome|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299355|NCT01249417|B2|Baseline|Dysport 15 U/Kg|Dysport 15 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
299238|NCT01249872|O4|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299239|NCT01249872|O3|Outcome|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299240|NCT01249872|O2|Outcome|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299241|NCT01249872|O1|Outcome|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299242|NCT01249872|O6|Outcome|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299243|NCT01249872|O5|Outcome|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299244|NCT01249872|O4|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299245|NCT01249872|O3|Outcome|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299246|NCT01249872|O2|Outcome|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299247|NCT01249872|O1|Outcome|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299248|NCT01249872|O6|Outcome|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299249|NCT01249872|O5|Outcome|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299250|NCT01249872|O4|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299251|NCT01249872|O3|Outcome|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299252|NCT01249872|O2|Outcome|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299253|NCT01249872|O1|Outcome|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299356|NCT01249417|B1|Baseline|Dysport 10 U/Kg|Dysport 10 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
299363|NCT01249417|O3|Outcome|Placebo|Placebo intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
299254|NCT01249872|O6|Outcome|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299255|NCT01249872|O5|Outcome|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299256|NCT01249872|O4|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299257|NCT01249872|O3|Outcome|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299258|NCT01249872|O2|Outcome|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299259|NCT01249872|O1|Outcome|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299260|NCT01249872|O6|Outcome|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299261|NCT01249872|O5|Outcome|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299262|NCT01249872|O4|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299263|NCT01249872|O3|Outcome|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299264|NCT01249872|O2|Outcome|GROUP B : 1 mg MORPHINE- 0.1%LEVOBUPIVACAINE|Group B patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299265|NCT01249872|O1|Outcome|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299266|NCT01249872|O6|Outcome|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299267|NCT01249872|O5|Outcome|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299268|NCT01249872|O4|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299269|NCT01249872|O3|Outcome|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299357|NCT01249417|P3|Participant Flow|Placebo|"Total volume to be injected per lower limb - 2ml. Either one or both lower limbs can be treated.~Placebo: I.M. injection on day 1 of a single treatment cycle."
299503|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
299270|NCT01249872|O2|Outcome|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299271|NCT01249872|O1|Outcome|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299272|NCT01249872|E6|Reported Event|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299273|NCT01249872|E5|Reported Event|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299274|NCT01249872|E4|Reported Event|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299275|NCT01249872|E3|Reported Event|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299276|NCT01249872|E2|Reported Event|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299277|NCT01249872|E1|Reported Event|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
299278|NCT01249833|B3|Baseline|Total|Total of all reporting groups
299279|NCT01249833|B2|Baseline|Standard of Care Alone|Standard of care for influenza
299280|NCT01249833|B1|Baseline|Oseltamivir|"Added to standard of care for influenza~Oseltamivir: Oseltamivir 75mg BID for 5 days"
299281|NCT01249833|P2|Participant Flow|Standard of Care Alone|Standard of care for influenza
299282|NCT01249833|P1|Participant Flow|Oseltamivir|"Added to standard of care for influenza~Oseltamivir: Oseltamivir 75mg BID for 5 days"
299283|NCT01249833|O2|Outcome|Standard of Care Alone|Standard of care for influenza
299284|NCT01249833|O1|Outcome|Oseltamivir|"Added to standard of care for influenza~Oseltamivir: Oseltamivir 75mg BID for 5 days"
299285|NCT01249833|O2|Outcome|Standard of Care Alone|Standard of care for influenza
299286|NCT01249833|O1|Outcome|Oseltamivir|"Added to standard of care for influenza~Oseltamivir: Oseltamivir 75mg BID for 5 days"
299287|NCT01249833|O2|Outcome|Standard of Care Alone|Standard of care for influenza
299288|NCT01249833|O1|Outcome|Oseltamivir|"Added to standard of care for influenza~Oseltamivir: Oseltamivir 75mg BID for 5 days"
299289|NCT01249833|O2|Outcome|Standard of Care Alone|Standard of care for influenza
299290|NCT01249833|O1|Outcome|Oseltamivir|"Added to standard of care for influenza~Oseltamivir: Oseltamivir 75mg BID for 5 days"
299291|NCT01249833|E2|Reported Event|Standard of Care Alone|Standard of care for influenza
299292|NCT01249833|E1|Reported Event|Oseltamivir|"Added to standard of care for influenza~Oseltamivir: Oseltamivir 75mg BID for 5 days"
299293|NCT01249664|B3|Baseline|Total|Total of all reporting groups
299294|NCT01249664|B2|Baseline|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299295|NCT01249664|B1|Baseline|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299296|NCT01249664|P2|Participant Flow|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299364|NCT01249417|O2|Outcome|Dysport 15 U/Kg|Dysport 15 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
299297|NCT01249664|P1|Participant Flow|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299298|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299299|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299300|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299301|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299302|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299303|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299304|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299305|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299306|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299307|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299308|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299309|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299310|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299311|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299312|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299313|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299314|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299315|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299316|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299317|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299318|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299319|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299320|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299321|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299358|NCT01249417|P2|Participant Flow|Dysport 15 U/Kg|"15 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.~Botulinum type A toxin (Dysport®): I.M. (in the muscle) injection on day 1 of a single treatment cycle."
299359|NCT01249417|P1|Participant Flow|Dysport 10 U/Kg|"10 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.~Botulinum type A toxin (Dysport®): I.M. (in the muscle) injection on day 1 of a single treatment cycle."
299322|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299323|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299324|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299325|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299326|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299327|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299328|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299329|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299330|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299331|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299332|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299333|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299360|NCT01249417|O3|Outcome|Placebo|Placebo intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
299361|NCT01249417|O2|Outcome|Dysport 15 U/Kg|Dysport 15 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
299362|NCT01249417|O1|Outcome|Dysport 10 U/Kg|Dysport 10 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
299334|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299335|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299336|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299337|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299338|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299339|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299340|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299341|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
299342|NCT01249664|E4|Reported Event|Sham Treatment Then Aflibercept Injection (Until Week 44)|Participants who continued the sham treatment until week 20 were monitored every 4 weeks and received a single 2 mg dose IAI at these visits from week 24 through week 44 only if the CNV persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment were not met, participant received a sham injection. Participants were observed from Week 24 until Week 48. Participants in the safety population were at risk.
299343|NCT01249664|E3|Reported Event|Aflibercept Injection (Until Week 44)|Participants who continued the study drug until week 20 were monitored every 4 weeks and received a single 2 mg dose IAI at these visits from week 24 through week 44 only if the CNV persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met, participant received a sham injection. Participants were observed from week 24 until week 48. Participants in the safety population were at risk.
299344|NCT01249664|E2|Reported Event|Sham Treatment (Until Week 20)|Participants received a sham injection every 4 weeks from week 0 through week 20. Participants were observed until week 24. Participants in the safety population were at risk.
299345|NCT01249664|E1|Reported Event|Aflibercept Injection (Until Week 20)|Participants received a 2 mg single dose of IAI at baseline (Week 20). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 20 only if the CNV persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met, participant received a sham injection. Participants were observed until week 24. Participants in the safety population were at risk.
299346|NCT01249651|B1|Baseline|Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
299347|NCT01249651|P1|Participant Flow|Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
299348|NCT01249651|O1|Outcome|Arm 1 - Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
299349|NCT01249651|O1|Outcome|Arm 1 - Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
299350|NCT01249651|O1|Outcome|Arm 1 - Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
299351|NCT01249651|O1|Outcome|Arm 1 - Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
299352|NCT01249651|E1|Reported Event|Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
299353|NCT01249417|B4|Baseline|Total|Total of all reporting groups
299354|NCT01249417|B3|Baseline|Placebo|Placebo intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
299365|NCT01249417|O1|Outcome|Dysport 10 U/Kg|Dysport 10 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
299366|NCT01249417|O3|Outcome|Placebo|Placebo intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
299367|NCT01249417|O2|Outcome|Dysport 15 U/Kg|Dysport 15 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
299368|NCT01249417|O1|Outcome|Dysport 10 U/Kg|Dysport 10 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
299369|NCT01249417|E3|Reported Event|Placebo|Placebo intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
299370|NCT01249417|E2|Reported Event|Dysport 15 U/Kg|Dysport 15 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
299371|NCT01249417|E1|Reported Event|Dysport 10 U/Kg|Dysport 10 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
299372|NCT01249404|B4|Baseline|Total Title|
299373|NCT01249404|B3|Baseline|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299374|NCT01249404|B2|Baseline|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299375|NCT01249404|B1|Baseline|Dysport® 1000 U|Subjects received i.m.injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299376|NCT01249404|P3|Participant Flow|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299377|NCT01249404|P2|Participant Flow|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299378|NCT01249404|P1|Participant Flow|Dysport® 1000 U|Subjects received intramuscular (i.m.) injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299379|NCT01249404|O3|Outcome|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299380|NCT01249404|O2|Outcome|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299381|NCT01249404|O1|Outcome|Dysport® 1000 U|Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299382|NCT01249404|O3|Outcome|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299383|NCT01249404|O2|Outcome|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299384|NCT01249404|O1|Outcome|Dysport® 1000 U|Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299385|NCT01249404|O3|Outcome|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299386|NCT01249404|O2|Outcome|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299387|NCT01249404|O1|Outcome|Dysport® 1000 U|Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299388|NCT01249404|O3|Outcome|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299389|NCT01249404|O2|Outcome|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299390|NCT01249404|O1|Outcome|Dysport® 1000 U|Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299391|NCT01249404|O3|Outcome|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299392|NCT01249404|O2|Outcome|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299393|NCT01249404|O1|Outcome|Dysport® 1000 U|Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299394|NCT01249404|O3|Outcome|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299395|NCT01249404|O2|Outcome|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299396|NCT01249404|O1|Outcome|Dysport® 1000 U|Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299397|NCT01249404|O3|Outcome|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299398|NCT01249404|O2|Outcome|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299399|NCT01249404|O1|Outcome|Dysport® 1000 U|Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299400|NCT01249404|O3|Outcome|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299401|NCT01249404|O2|Outcome|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299402|NCT01249404|O1|Outcome|Dysport® 1000 U|Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299403|NCT01249404|O3|Outcome|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299404|NCT01249404|O2|Outcome|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299405|NCT01249404|O1|Outcome|Dysport® 1000 U|Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299406|NCT01249404|O3|Outcome|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299407|NCT01249404|O2|Outcome|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299408|NCT01249404|O1|Outcome|Dysport® 1000 U|Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299409|NCT01249404|O3|Outcome|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299430|NCT01249404|O3|Outcome|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299410|NCT01249404|O2|Outcome|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299411|NCT01249404|O1|Outcome|Dysport® 1000 U|Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299412|NCT01249404|O3|Outcome|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299413|NCT01249404|O2|Outcome|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299414|NCT01249404|O1|Outcome|Dysport® 1000 U|Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299415|NCT01249404|O3|Outcome|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299416|NCT01249404|O2|Outcome|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299417|NCT01249404|O1|Outcome|Dysport® 1000 U|Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299418|NCT01249404|O3|Outcome|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299419|NCT01249404|O2|Outcome|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299420|NCT01249404|O1|Outcome|Dysport® 1000 U|Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299421|NCT01249404|O3|Outcome|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299422|NCT01249404|O2|Outcome|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299423|NCT01249404|O1|Outcome|Dysport® 1000 U|Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299424|NCT01249404|O3|Outcome|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299425|NCT01249404|O2|Outcome|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299426|NCT01249404|O1|Outcome|Dysport® 1000 U|Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299427|NCT01249404|O3|Outcome|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299428|NCT01249404|O2|Outcome|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299429|NCT01249404|O1|Outcome|Dysport® 1000 U|Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299502|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
299431|NCT01249404|O2|Outcome|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299432|NCT01249404|O1|Outcome|Dysport® 1000 U|Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299433|NCT01249404|O3|Outcome|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299434|NCT01249404|O2|Outcome|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299435|NCT01249404|O1|Outcome|Dysport® 1000 U|Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299436|NCT01249404|O3|Outcome|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299437|NCT01249404|O2|Outcome|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299438|NCT01249404|O1|Outcome|Dysport® 1000 U|Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299439|NCT01249404|O3|Outcome|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299440|NCT01249404|O2|Outcome|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299441|NCT01249404|O1|Outcome|Dysport® 1000 U|Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299442|NCT01249404|O3|Outcome|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299443|NCT01249404|O2|Outcome|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299444|NCT01249404|O1|Outcome|Dysport® 1000 U|Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299445|NCT01249404|O3|Outcome|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299446|NCT01249404|O2|Outcome|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299447|NCT01249404|O1|Outcome|Dysport® 1000 U|Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299448|NCT01249404|O3|Outcome|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299449|NCT01249404|O2|Outcome|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299450|NCT01249404|O1|Outcome|Dysport® 1000 U|Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299504|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
299451|NCT01249404|E3|Reported Event|Placebo|Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
299452|NCT01249404|E2|Reported Event|Dysport® 1500 U|Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299453|NCT01249404|E1|Reported Event|Dysport® 1000 U|Subjects received intramuscular (i.m.) injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
299454|NCT01249274|B3|Baseline|Total|Total of all reporting groups
299455|NCT01249274|B2|Baseline|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
299456|NCT01249274|B1|Baseline|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
299457|NCT01249274|P2|Participant Flow|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
299458|NCT01249274|P1|Participant Flow|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
299459|NCT01249274|O2|Outcome|Progesterone|Progesterone: 100mgs progesterone twice daily
299460|NCT01249274|O1|Outcome|Placebo|Placebo: Matched placebo pills to be taken twice daily
299461|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
299462|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
299463|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
299464|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
299465|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
299466|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
299467|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
299468|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
299469|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
299470|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
299471|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
299472|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
299473|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
299474|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
299475|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
299476|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
299477|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
299478|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
299479|NCT01249274|E2|Reported Event|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
299480|NCT01249274|E1|Reported Event|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
299481|NCT01249261|B3|Baseline|Total|Total of all reporting groups
299482|NCT01249261|B2|Baseline|Risedronate|Risedronate 5mg years 1-7, no drug year 8
299483|NCT01249261|B1|Baseline|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
299484|NCT01249261|P2|Participant Flow|Risedronate|Risedronate 5mg years 1-7, no drug year 8
299485|NCT01249261|P1|Participant Flow|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
299486|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
299487|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
299488|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
299489|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
299490|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
299491|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
299492|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
299493|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
299494|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
299495|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
299496|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
299497|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
299498|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
299499|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
299500|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
299501|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
299505|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
299506|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
299507|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
299508|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
299509|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
299510|NCT01249261|E2|Reported Event|Risedronate|Risedronate 5mg years 1-7, no drug year 8
299511|NCT01249261|E1|Reported Event|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
299512|NCT01249157|B1|Baseline|Preoperative 18FDG PEM and MRI|Female patients with recently diagnosed invasive or in situ breast cancer.The first 5 patients who consent to the study will be intended for training purposes only.
299513|NCT01249157|P1|Participant Flow|Preoperative 18FDG PEM and MRI|Female patients with recently diagnosed invasive or in situ breast cancer
299514|NCT01249157|O1|Outcome|Preoperative 18FDG PEM and MRI|Female patients with recently diagnosed invasive or in situ breast cancer
299515|NCT01249157|E1|Reported Event|Preoperative 18FDG PEM and MRI|Female patients with recently diagnosed invasive or in situ breast cancer
299516|NCT01249131|B1|Baseline|Entire Study Population|All participants randomized to any treatment.
299517|NCT01249131|P6|Participant Flow|Treatment C First, Then Treatment B, Followed by Treatment A|Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in first intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
299518|NCT01249131|P5|Participant Flow|Treatment C First, Then Treatment A, Followed by Treatment B|Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in first intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
299519|NCT01249131|P4|Participant Flow|Treatment B First, Then Treatment C, Followed by Treatment A|Treatment B first, then Treatment C, followed by Treatment A Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in second intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
299520|NCT01249131|P3|Participant Flow|Treatment B First, Then Treatment A, Followed by Treatment C|Treatment B first, then Treatment A, followed by Treatment C Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in third intervention period.
299521|NCT01249131|P2|Participant Flow|Treatment A First, Then Treatment C, Followed by Treatment B|Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in second intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
299522|NCT01249131|P1|Participant Flow|Treatment A First, Then Treatment B, Followed by Treatment C|Treatment A: One 20-milligram (mg) tablet of cobimetinib administered orally with 240 milliliter (mL) room temperature water after at least an 8-hour fast, in first intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard Food and Drug Administration (FDA) high-fat meal, in third intervention period. The washout period between each period was a minimum of 10 days.
299523|NCT01249131|O3|Outcome|Cobimetinib One 20 mg Tablet [Fed]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
299524|NCT01249131|O2|Outcome|Cobimetinib Four 5 mg Capsules [Fasted]|Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
299525|NCT01249131|O1|Outcome|Cobimetinib One 20 mg Tablet [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
299526|NCT01249131|O3|Outcome|Cobimetinib One 20 mg Tablet [Fed]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
299527|NCT01249131|O2|Outcome|Cobimetinib Four 5 mg Capsules [Fasted]|Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
299528|NCT01249131|O1|Outcome|Cobimetinib One 20 mg Tablet [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
299529|NCT01249131|O3|Outcome|Cobimetinib One 20 mg Tablet [Fed]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
299530|NCT01249131|O2|Outcome|Cobimetinib Four 5 mg Capsules [Fasted]|Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
299531|NCT01249131|O1|Outcome|Cobimetinib One 20 mg Tablet [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
299778|NCT01248793|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20
299532|NCT01249131|O3|Outcome|Cobimetinib One 20 mg Tablet [Fed]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
299533|NCT01249131|O2|Outcome|Cobimetinib Four 5 mg Capsules [Fasted]|Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
299534|NCT01249131|O1|Outcome|Cobimetinib One 20 mg Tablet [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
299535|NCT01249131|O3|Outcome|Cobimetinib One 20 mg Tablet [Fed]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
299536|NCT01249131|O2|Outcome|Cobimetinib Four 5 mg Capsules [Fasted]|Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
299537|NCT01249131|O1|Outcome|Cobimetinib One 20 mg Tablet [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
299538|NCT01249131|E3|Reported Event|Cobimetinib One 20 mg Tablet [Fed]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
299539|NCT01249131|E2|Reported Event|Cobimetinib Four 5 mg Capsules [Fasted]|Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
299540|NCT01249131|E1|Reported Event|Cobimetinib One 20 mg Tablet [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
299541|NCT01249118|B1|Baseline|Entire Study Population|"Part 1: Participants received single dose of GDC-0973 2 mg IV infusion in first intervention period followed by single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in second intervention period. There was a washout period of minimum 10 days after each intervention period.~Part 2: Participants received single dose of GDC-0973 2 mg IV infusion and GDC-0973 20 mg oral capsules (four 5-mg capsules) in either of the two intervention periods. There was a washout period of minimum 10 days after each intervention period."
299542|NCT01249118|P3|Participant Flow|Part 2: GDC-0973 Capsules First, Then GDC-0973 IV Infusion|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in first intervention period followed by single dose of GDC-0973 2 mg IV infusion in second intervention period. There was a washout period of minimum 10 days after each intervention period.
299543|NCT01249118|P2|Participant Flow|Part 2: GDC-0973 IV Infusion First, Then GDC-0973 Capsules|Participants received single dose of GDC-0973 2 mg IV infusion in first intervention period followed by single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in second intervention period. There was a washout period of minimum 10 days after each intervention period.
299544|NCT01249118|P1|Participant Flow|Part 1: GDC-0973 IV Infusion First, Then GDC-0973 Capsules|Participants received single dose of GDC-0973 2 milligrams (mg) intravenous (IV) infusion in first intervention period followed by single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in second intervention period. There was a washout period of minimum 10 days after each intervention period.
299545|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
299546|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
299547|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
299548|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
299549|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
299550|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
299551|NCT01249118|O1|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
299552|NCT01249118|O1|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
299553|NCT01249118|O1|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
299554|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
299555|NCT01249118|O1|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
299556|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
299557|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
299558|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
299559|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
299560|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
299561|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
299562|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
299563|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
299564|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
299565|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
299566|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
299567|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
299568|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
299569|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
299570|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
299571|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
299572|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
299573|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
299574|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
299575|NCT01249118|E2|Reported Event|GDC-0973 20 mg Oral|Participants received GDC-0973 20 mg oral capsules (four 5-mg capsule) in either intervention period in part 1 and part 2 of the study.
299576|NCT01249118|E1|Reported Event|GDC-0973 2 mg IV|Participants received GDC-0973 2 mg IV infusion in either intervention period in part 1 and part 2 of the study.
299577|NCT01249092|B1|Baseline|Pentoxifylline 400 mg/d|All patients received same intervention.
299578|NCT01249092|P1|Participant Flow|Pentoxifylline 400 mg/d|All patients received same intervention.
299579|NCT01249092|O1|Outcome|Pentoxifylline 400 mg/d|Descriptive information only of small open label pilot. Small patient number not amenable for any valid statistical comparisons regarding side effects. All patients received same intervention. No SAEs occurred.
299580|NCT01249092|O1|Outcome|Change in Serum TIMP-1 (Tissue Inhibitor metalloproteinase1)|
299581|NCT01249092|O1|Outcome|Change in Alkaline Phosphatase After Pentoxifylline Therapy|
299582|NCT01249092|E1|Reported Event|Pentoxifylline 400 mg/d|All patients received same intervention.
299583|NCT01248949|B6|Baseline|Total|Total of all reporting groups
299584|NCT01248949|B5|Baseline|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
299585|NCT01248949|B4|Baseline|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
299586|NCT01248949|B3|Baseline|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
299587|NCT01248949|B2|Baseline|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299588|NCT01248949|B1|Baseline|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299589|NCT01248949|P5|Participant Flow|MEDI3617 + CARBOPLATIN/ PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
299590|NCT01248949|P4|Participant Flow|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
299591|NCT01248949|P3|Participant Flow|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
299592|NCT01248949|P2|Participant Flow|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299593|NCT01248949|P1|Participant Flow|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299594|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
299595|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
299777|NCT01248793|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape
299596|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
299597|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299598|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299599|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
299600|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
299601|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
299602|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299603|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299604|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
299605|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
299606|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
299607|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299608|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299609|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
299610|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
299611|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
299612|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299613|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299614|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
299615|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
299616|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
299617|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299618|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299619|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
299620|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
299621|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
299622|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299623|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299624|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
299625|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
299626|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
299627|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299628|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299629|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
299630|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
299631|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
299632|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299633|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299634|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
299635|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
299636|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
299637|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299638|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299639|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
299640|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
299641|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
299642|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299643|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299644|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
299645|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
299646|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
299647|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299648|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299649|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
299650|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
299651|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
299652|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299653|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299654|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
299655|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
299656|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
299657|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299658|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299659|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
299660|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
299661|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
299662|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299663|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299664|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
299665|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
299666|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
299667|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299668|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299669|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
299670|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
299671|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
299672|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299673|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299674|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
299675|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
299676|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
299677|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299678|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299679|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
299680|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
299681|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
299682|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299683|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299684|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
299685|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
299686|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
299687|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299688|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299689|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
299690|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
299691|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
299692|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299693|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299694|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
299695|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
299696|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
299697|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299698|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299699|NCT01248949|E5|Reported Event|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
299700|NCT01248949|E4|Reported Event|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
299701|NCT01248949|E3|Reported Event|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
299702|NCT01248949|E2|Reported Event|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299703|NCT01248949|E1|Reported Event|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
299704|NCT01248936|B1|Baseline|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor.
299705|NCT01248936|P1|Participant Flow|Overall Trial|Participants received vemurafenib 960 milligram (mg) orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor.
299706|NCT01248936|O1|Outcome|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
299707|NCT01248936|O1|Outcome|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
299708|NCT01248936|O1|Outcome|Overall Trial|Participants received Vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, Unmanageable toxicity most probably attributable to Vemurafenib, withdrawal of consent, and Study termination by the Sponsor
299709|NCT01248936|O1|Outcome|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
299710|NCT01248936|O1|Outcome|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
299711|NCT01248936|O1|Outcome|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
299712|NCT01248936|O1|Outcome|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
299713|NCT01248936|E1|Reported Event|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
299714|NCT01248884|B4|Baseline|Total|Total of all reporting groups
299715|NCT01248884|B3|Baseline|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299716|NCT01248884|B2|Baseline|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299717|NCT01248884|B1|Baseline|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299718|NCT01248884|P3|Participant Flow|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
299719|NCT01248884|P2|Participant Flow|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299720|NCT01248884|P1|Participant Flow|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299721|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexaTM vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexaTM and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299722|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299723|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299724|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexaTM vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexaTM and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299725|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299726|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299727|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
299728|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299729|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299730|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
299731|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299732|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299733|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
299734|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
306244|NCT01229228|O2|Outcome|Naproxen Test (Upper Dose)|400-mg (2 x 200-mg)
299735|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299736|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
299737|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299738|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299739|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299740|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299741|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299742|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
299743|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299744|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299745|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
299746|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299747|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299748|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
299749|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299750|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299751|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
299752|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299753|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
306245|NCT01229228|O1|Outcome|Naproxen Test (Lower Dose)|200-mg single dose
299754|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
299755|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299756|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299757|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
299758|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299759|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299760|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
299761|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299762|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299763|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
299764|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299765|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299766|NCT01248884|E3|Reported Event|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
299767|NCT01248884|E2|Reported Event|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299768|NCT01248884|E1|Reported Event|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
299769|NCT01248793|B3|Baseline|Total|Total of all reporting groups
299770|NCT01248793|B2|Baseline|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48
299771|NCT01248793|B1|Baseline|Group I: Placebo|Placebo SC injections every 4 weeks from Week 0 to Week 20(unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; Golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape
299772|NCT01248793|P2|Participant Flow|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48
299773|NCT01248793|P1|Participant Flow|Group I: Placebo|Placebo SC injections every 4 weeks from Week 0 to Week 20(unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; Golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape
299774|NCT01248793|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20
299775|NCT01248793|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape
299776|NCT01248793|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20
306246|NCT01229228|E5|Reported Event|Placebo|
299779|NCT01248793|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape
299780|NCT01248793|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20
299781|NCT01248793|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape
299782|NCT01248793|E2|Reported Event|Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48
299783|NCT01248793|E1|Reported Event|Placebo -> Golimumab 50 mg|Placebo SC injections every 4 weeks from Week 0 to Week 12 and early escape to receive Golimumab 50 mg SC injection every 4 weeks from Week 16 to Week 20; or Placebo SC injections every 4 weeks from Week 0 to Week 20 and crossed over to receive Golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48
299784|NCT01248780|B3|Baseline|Total|Total of all reporting groups
299785|NCT01248780|B2|Baseline|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48; In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
299786|NCT01248780|B1|Baseline|Group I: Placebo + MTX -> Golimumab 50 mg + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape. In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
299787|NCT01248780|P2|Participant Flow|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48; In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
299788|NCT01248780|P1|Participant Flow|Group I: Placebo + MTX -> Golimumab 50 mg + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape. In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
299789|NCT01248780|O2|Outcome|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
299790|NCT01248780|O1|Outcome|Group I: Placebo + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
299791|NCT01248780|O2|Outcome|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
299792|NCT01248780|O1|Outcome|Group I: Placebo + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
299793|NCT01248780|O2|Outcome|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
299794|NCT01248780|O1|Outcome|Group I: Placebo + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
299795|NCT01248780|O2|Outcome|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
299796|NCT01248780|O1|Outcome|Group I: Placebo + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
299797|NCT01248780|E2|Reported Event|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48; In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
299798|NCT01248780|E1|Reported Event|Group I: Placebo + MTX -> Golimumab 50 mg + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 12 and early escaped to receive golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48; or placebo SC injections every 4 weeks from Week 0 to Week 20 and crossed over to receive golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48. In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
299799|NCT01248728|B3|Baseline|Total|Total of all reporting groups
299800|NCT01248728|B2|Baseline|Placebo|"Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor."
299801|NCT01248728|B1|Baseline|Omega-3 Fatty Acids|"Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor."
299802|NCT01248728|P2|Participant Flow|Placebo|"Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor."
299848|NCT01248468|O2|Outcome|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
299803|NCT01248728|P1|Participant Flow|Omega-3 Fatty Acids|"Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor."
299804|NCT01248728|O2|Outcome|Placebo|Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
299805|NCT01248728|O1|Outcome|Omega-3 Fatty Acids|Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
299806|NCT01248728|O2|Outcome|Placebo|Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
299807|NCT01248728|O1|Outcome|Omega-3 Fatty Acids|Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
299808|NCT01248728|O2|Outcome|Placebo|Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
299809|NCT01248728|O1|Outcome|Omega-3 Fatty Acids|Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
299810|NCT01248728|O2|Outcome|Placebo|Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
299811|NCT01248728|O1|Outcome|Omega-3 Fatty Acids|Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
299812|NCT01248728|O2|Outcome|Placebo|"Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor."
299813|NCT01248728|O1|Outcome|Omega-3 Fatty Acids|"Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor."
299814|NCT01248728|E2|Reported Event|Placebo|"Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor."
299815|NCT01248728|E1|Reported Event|Omega-3 Fatty Acids|"Children will be administered 3.75ml of the liquid formulation of NutraSea HP (containing 1.5 gr of EPA+DHA). The starting dose will be 1.875ml (0.75 gr of EPA+DHA) and the dose will be doubled on week 2. The parents may choose to give this as a single dose or split it to two doses if stomach upset occurs. This formulation is double distilled and has very little fishy taste, which will make it more palatable for children and will make creating a matching placebo a simpler process.~Omega-3 Fatty Acids: Children will be administered 3.75ml of the liquid formulation of NutraSea HP (containing 1.5 gr of EPA+DHA). The starting dose will be 1.875ml (0.75 gr of EPA+DHA) and the dose will be doubled on week 2. The parents may choose to give this as a single dose or split it to two doses if stomach upset occurs. This formulation is double distilled and has very little fishy taste, which will make it more palatable for children and will make creating a matching placebo a simpler process."
299816|NCT01248715|B3|Baseline|Total|Total of all reporting groups
299817|NCT01248715|B2|Baseline|Standard of Care|These patients will be treated with the current, standard care, including currently recommended antibiotics or antiviral therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP and ACIP antiviral use guidelines for hospitalized patients with confirmed of suspect influenza, per clinician discretion. In addition these patients with have a NP swab collected for influenza PCR testing and clinical information will be extracted from the medical record.
299849|NCT01248468|O1|Outcome|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
299850|NCT01248468|O3|Outcome|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
299818|NCT01248715|B1|Baseline|Oseltamirvir|"These patients will receive early oseltamivir plus current, standard empiric antibacterial therapy.~oseltamivir: These patients will receive early (within 8-12 hours of admission, no later than 24 hours after admission) oseltamivir plus current, standard empiric antibacterial therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP (2). Anti-influenza therapy will be given using oseltamivir at a dose of 75 mg twice daily. The oseltamivir dose will be adjusted in patients with renal insufficiency according to the package insert. Duration of antiviral therapy will be for a minimum of 5 days for patients with evidence of early clinical improvement and prolonged depending on clinical stability"
299819|NCT01248715|P2|Participant Flow|Standard of Care|These patients will be treated with the current, standard care, including currently recommended antibiotics or antiviral therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP and ACIP antiviral use guidelines for hospitalized patients with confirmed of suspect influenza, per clinician discretion. In addition these patients with have a NP swab collected for influenza PCR testing and clinical information will be extracted from the medical record.
299820|NCT01248715|P1|Participant Flow|Oseltamirvir|"These patients will receive early oseltamivir plus current, standard empiric antibacterial therapy.~oseltamivir: These patients will receive early (within 8-12 hours of admission, no later than 24 hours after admission) oseltamivir plus current, standard empiric antibacterial therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP (2). Anti-influenza therapy will be given using oseltamivir at a dose of 75 mg twice daily. The oseltamivir dose will be adjusted in patients with renal insufficiency according to the package insert. Duration of antiviral therapy will be for a minimum of 5 days for patients with evidence of early clinical improvement and prolonged depending on clinical stability"
299821|NCT01248715|O2|Outcome|Standard of Care|These patients will be treated with the current, standard care, including currently recommended antibiotics or antiviral therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP and ACIP antiviral use guidelines for hospitalized patients with confirmed of suspect influenza, per clinician discretion. In addition these patients with have a NP swab collected for influenza PCR testing and clinical information will be extracted from the medical record.
299822|NCT01248715|O1|Outcome|Oseltamirvir|"These patients will receive early oseltamivir plus current, standard empiric antibacterial therapy.~oseltamivir: These patients will receive early (within 8-12 hours of admission, no later than 24 hours after admission) oseltamivir plus current, standard empiric antibacterial therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP (2). Anti-influenza therapy will be given using oseltamivir at a dose of 75 mg twice daily. The oseltamivir dose will be adjusted in patients with renal insufficiency according to the package insert. Duration of antiviral therapy will be for a minimum of 5 days for patients with evidence of early clinical improvement and prolonged depending on clinical stability"
299823|NCT01248715|O2|Outcome|Standard of Care|These patients will be treated with the current, standard care, including currently recommended antibiotics or antiviral therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP and ACIP antiviral use guidelines for hospitalized patients with confirmed of suspect influenza, per clinician discretion. In addition these patients with have a NP swab collected for influenza PCR testing and clinical information will be extracted from the medical record.
299824|NCT01248715|O1|Outcome|Oseltamirvir|"These patients will receive early oseltamivir plus current, standard empiric antibacterial therapy.~oseltamivir: These patients will receive early (within 8-12 hours of admission, no later than 24 hours after admission) oseltamivir plus current, standard empiric antibacterial therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP (2). Anti-influenza therapy will be given using oseltamivir at a dose of 75 mg twice daily. The oseltamivir dose will be adjusted in patients with renal insufficiency according to the package insert. Duration of antiviral therapy will be for a minimum of 5 days for patients with evidence of early clinical improvement and prolonged depending on clinical stability"
299825|NCT01248715|O2|Outcome|Standard of Care|These patients will be treated with the current, standard care, including currently recommended antibiotics or antiviral therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP and ACIP antiviral use guidelines for hospitalized patients with confirmed of suspect influenza, per clinician discretion. In addition these patients with have a NP swab collected for influenza PCR testing and clinical information will be extracted from the medical record.
299826|NCT01248715|O1|Outcome|Oseltamirvir|"These patients will receive early oseltamivir plus current, standard empiric antibacterial therapy.~oseltamivir: These patients will receive early (within 8-12 hours of admission, no later than 24 hours after admission) oseltamivir plus current, standard empiric antibacterial therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP (2). Anti-influenza therapy will be given using oseltamivir at a dose of 75 mg twice daily. The oseltamivir dose will be adjusted in patients with renal insufficiency according to the package insert. Duration of antiviral therapy will be for a minimum of 5 days for patients with evidence of early clinical improvement and prolonged depending on clinical stability"
299827|NCT01248715|O2|Outcome|Standard of Care|These patients will be treated with the current, standard care, including currently recommended antibiotics or antiviral therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP and ACIP antiviral use guidelines for hospitalized patients with confirmed of suspect influenza, per clinician discretion. In addition these patients with have a NP swab collected for influenza PCR testing and clinical information will be extracted from the medical record.
299828|NCT01248715|O1|Outcome|Oseltamirvir|"These patients will receive early oseltamivir plus current, standard empiric antibacterial therapy.~oseltamivir: These patients will receive early (within 8-12 hours of admission, no later than 24 hours after admission) oseltamivir plus current, standard empiric antibacterial therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP (2). Anti-influenza therapy will be given using oseltamivir at a dose of 75 mg twice daily. The oseltamivir dose will be adjusted in patients with renal insufficiency according to the package insert. Duration of antiviral therapy will be for a minimum of 5 days for patients with evidence of early clinical improvement and prolonged depending on clinical stability"
299960|NCT01247974|B3|Baseline|Total|Total of all reporting groups
299829|NCT01248715|O2|Outcome|Standard of Care|These patients will be treated with the current, standard care, including currently recommended antibiotics or antiviral therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP and ACIP antiviral use guidelines for hospitalized patients with confirmed of suspect influenza, per clinician discretion. In addition these patients with have a NP swab collected for influenza PCR testing and clinical information will be extracted from the medical record.
299830|NCT01248715|O1|Outcome|Oseltamirvir|"These patients will receive early oseltamivir plus current, standard empiric antibacterial therapy.~oseltamivir: These patients will receive early (within 8-12 hours of admission, no later than 24 hours after admission) oseltamivir plus current, standard empiric antibacterial therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP (2). Anti-influenza therapy will be given using oseltamivir at a dose of 75 mg twice daily. The oseltamivir dose will be adjusted in patients with renal insufficiency according to the package insert. Duration of antiviral therapy will be for a minimum of 5 days for patients with evidence of early clinical improvement and prolonged depending on clinical stability"
299831|NCT01248715|O2|Outcome|Standard of Care|These patients will be treated with the current, standard care, including currently recommended antibiotics or antiviral therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP and ACIP antiviral use guidelines for hospitalized patients with confirmed of suspect influenza, per clinician discretion. In addition these patients with have a NP swab collected for influenza PCR testing and clinical information will be extracted from the medical record.
299832|NCT01248715|O1|Outcome|Oseltamirvir|"These patients will receive early oseltamivir plus current, standard empiric antibacterial therapy.~oseltamivir: These patients will receive early (within 8-12 hours of admission, no later than 24 hours after admission) oseltamivir plus current, standard empiric antibacterial therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP (2). Anti-influenza therapy will be given using oseltamivir at a dose of 75 mg twice daily. The oseltamivir dose will be adjusted in patients with renal insufficiency according to the package insert. Duration of antiviral therapy will be for a minimum of 5 days for patients with evidence of early clinical improvement and prolonged depending on clinical stability"
299833|NCT01248715|O2|Outcome|Standard of Care|These patients will be treated with the current, standard care, including currently recommended antibiotics or antiviral therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP and ACIP antiviral use guidelines for hospitalized patients with confirmed of suspect influenza, per clinician discretion. In addition these patients with have a NP swab collected for influenza PCR testing and clinical information will be extracted from the medical record.
299834|NCT01248715|O1|Outcome|Oseltamirvir|"These patients will receive early oseltamivir plus current, standard empiric antibacterial therapy.~oseltamivir: These patients will receive early (within 8-12 hours of admission, no later than 24 hours after admission) oseltamivir plus current, standard empiric antibacterial therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP (2). Anti-influenza therapy will be given using oseltamivir at a dose of 75 mg twice daily. The oseltamivir dose will be adjusted in patients with renal insufficiency according to the package insert. Duration of antiviral therapy will be for a minimum of 5 days for patients with evidence of early clinical improvement and prolonged depending on clinical stability"
299835|NCT01248715|E2|Reported Event|Standard of Care|These patients will be treated with the current, standard care, including currently recommended antibiotics or antiviral therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP and ACIP antiviral use guidelines for hospitalized patients with confirmed of suspect influenza, per clinician discretion. In addition these patients with have a NP swab collected for influenza PCR testing and clinical information will be extracted from the medical record.
299836|NCT01248715|E1|Reported Event|Oseltamirvir|"These patients will receive early oseltamivir plus current, standard empiric antibacterial therapy.~oseltamivir: These patients will receive early (within 8-12 hours of admission, no later than 24 hours after admission) oseltamivir plus current, standard empiric antibacterial therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP (2). Anti-influenza therapy will be given using oseltamivir at a dose of 75 mg twice daily. The oseltamivir dose will be adjusted in patients with renal insufficiency according to the package insert. Duration of antiviral therapy will be for a minimum of 5 days for patients with evidence of early clinical improvement and prolonged depending on clinical stability"
299837|NCT01248468|B4|Baseline|Total|Total of all reporting groups
299838|NCT01248468|B3|Baseline|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
299839|NCT01248468|B2|Baseline|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
299840|NCT01248468|B1|Baseline|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
299841|NCT01248468|P3|Participant Flow|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
299842|NCT01248468|P2|Participant Flow|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
299843|NCT01248468|P1|Participant Flow|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
299844|NCT01248468|O3|Outcome|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
299845|NCT01248468|O2|Outcome|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
299846|NCT01248468|O1|Outcome|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
299847|NCT01248468|O3|Outcome|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
299851|NCT01248468|O2|Outcome|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
299852|NCT01248468|O1|Outcome|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
299853|NCT01248468|O3|Outcome|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
299854|NCT01248468|O2|Outcome|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
299855|NCT01248468|O1|Outcome|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
299856|NCT01248468|E3|Reported Event|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
299857|NCT01248468|E2|Reported Event|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
299858|NCT01248468|E1|Reported Event|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
299859|NCT01248455|B1|Baseline|Anti-KIR in Smoldering Multiple Myeloma Patients|"Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles~(Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles"
299860|NCT01248455|P1|Participant Flow|Anti-KIR in Smoldering Multiple Myeloma Patients|"Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles~(Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles"
299861|NCT01248455|O1|Outcome|Anti-KIR in Smoldering Multiple Myeloma Patients|"Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles~(Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles"
299862|NCT01248455|O1|Outcome|Anti-KIR in Smoldering Multiple Myeloma Patients|"Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles~(Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles"
299863|NCT01248455|E1|Reported Event|Anti-KIR in Smoldering Multiple Myeloma Patients|"Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles~(Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles"
299864|NCT01248364|B5|Baseline|Total|Total of all reporting groups
299865|NCT01248364|B4|Baseline|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
299866|NCT01248364|B3|Baseline|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299867|NCT01248364|B2|Baseline|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299868|NCT01248364|B1|Baseline|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299869|NCT01248364|P4|Participant Flow|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
299870|NCT01248364|P3|Participant Flow|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299871|NCT01248364|P2|Participant Flow|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299872|NCT01248364|P1|Participant Flow|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299873|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
299874|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299875|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299876|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299877|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
299878|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299879|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299880|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299881|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
299882|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299883|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299884|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299885|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
299886|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299887|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299888|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299889|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
299890|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299891|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299892|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299893|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
299894|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299895|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299896|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299897|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
299898|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299899|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299900|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299901|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
299902|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299903|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299904|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299905|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
299906|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299907|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299908|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299909|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
299910|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299911|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299912|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299913|NCT01248364|E4|Reported Event|Healthy Subjects|Healthy subjects received empagliflozin (empa) 25mg tablet once daily for 28 days.
299914|NCT01248364|E3|Reported Event|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299915|NCT01248364|E2|Reported Event|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299916|NCT01248364|E1|Reported Event|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
299917|NCT01248221|B3|Baseline|Total|Total of all reporting groups
299918|NCT01248221|B2|Baseline|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
299919|NCT01248221|B1|Baseline|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
299920|NCT01248221|P2|Participant Flow|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
299921|NCT01248221|P1|Participant Flow|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
299922|NCT01248221|O2|Outcome|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
299923|NCT01248221|O1|Outcome|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
299924|NCT01248221|O2|Outcome|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
299925|NCT01248221|O1|Outcome|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
299926|NCT01248221|O2|Outcome|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
299927|NCT01248221|O1|Outcome|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
299928|NCT01248221|O2|Outcome|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and Technetium-99m (99mTc) sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
299929|NCT01248221|O1|Outcome|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and Technetium-99m (99mTc) sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
299930|NCT01248221|E2|Reported Event|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
299931|NCT01248221|E1|Reported Event|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
299932|NCT01248130|B3|Baseline|Total|Total of all reporting groups
299933|NCT01248130|B2|Baseline|Placebo (Sugar Pill)|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
299934|NCT01248130|B1|Baseline|Omega-3 Fatty Acid Treatment|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
299935|NCT01248130|P2|Participant Flow|Placebo (Sugar Pill)|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
299936|NCT01248130|P1|Participant Flow|Omega-3 Fatty Acid Treatment|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
299937|NCT01248130|O2|Outcome|Placebo (Sugar Pill)|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
299938|NCT01248130|O1|Outcome|Omega-3 Fatty Acid Treatment|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
299961|NCT01247974|B2|Baseline|Control|No closure of pericardium
299962|NCT01247974|B1|Baseline|CorMatrix® ECM®|CorMatrix® ECM® for Pericardial Closure: Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure
299963|NCT01247974|P2|Participant Flow|Control|Pericardium is not closed
300205|NCT01247090|E1|Reported Event|Very Low Dose|Very Low Dose: Active Comparator 0.15 mU per kg per minute
299939|NCT01248130|O2|Outcome|Placebo (Sugar Pill)|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
299940|NCT01248130|O1|Outcome|Omega-3 Fatty Acid Treatment|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
299941|NCT01248130|E2|Reported Event|Placebo (Sugar Pill)|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
299942|NCT01248130|E1|Reported Event|Omega-3 Fatty Acid Treatment|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
299943|NCT01248065|B3|Baseline|Total|Total of all reporting groups
299944|NCT01248065|B2|Baseline|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)~Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
299945|NCT01248065|B1|Baseline|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
299946|NCT01248065|P2|Participant Flow|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)~Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
299947|NCT01248065|P1|Participant Flow|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
299948|NCT01248065|O2|Outcome|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)~Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
299949|NCT01248065|O1|Outcome|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
299950|NCT01248065|O2|Outcome|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)~Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
299951|NCT01248065|O1|Outcome|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
299952|NCT01248065|O2|Outcome|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)~Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
299953|NCT01248065|O1|Outcome|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
299954|NCT01248065|E2|Reported Event|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)~Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
299955|NCT01248065|E1|Reported Event|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
299956|NCT01248013|B1|Baseline|Group Hypnotherapy for Irritable Bowel Syndrome|IBS subjects, in groups of 3 to 8 participants, received a specific gut focused hypnotherapy protocol. Meetings were bi-weekly, seven in all, and each meeting was 45 minutes in length. CD's were distributed for use at home between meetings.
299957|NCT01248013|P1|Participant Flow|Group Hypnotherapy for Irritable Bowel Syndrome|IBS subjects, in groups of 3 to 8 participants, received a specific gut focused hypnotherapy protocol. Meetings were bi-weekly, seven in all, and each meeting was 45 minutes in length. CD's were distributed for use at home between meetings.
299958|NCT01248013|O1|Outcome|Group Hypnotherapy for Irritable Bowel Syndrome|IBS subjects, in groups of 3 to 8 participants, received a specific gut focused hypnotherapy protocol. Meetings were bi-weekly, seven in all, and each meeting was 45 minutes in length. CD's were distributed for use at home between meetings.
299959|NCT01248013|E1|Reported Event|Group Hypnotherapy for Irritable Bowel Syndrome|IBS subjects, in groups of 3 to 8 participants, received a specific gut focused hypnotherapy protocol. Meetings were bi-weekly, seven in all, and each meeting was 45 minutes in length. CD's were distributed for use at home between meetings.
299964|NCT01247974|P1|Participant Flow|CorMatrix® ECM®|CorMatrix® ECM® for Pericardial Closure: Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure
299965|NCT01247974|O2|Outcome|Control|No Pericardial Closure
299966|NCT01247974|O1|Outcome|CorMatrix ECM for Pericardial Closure|Pericardial closure with CorMatrix ECM
299967|NCT01247974|O2|Outcome|Control|No Pericardial Closure
299968|NCT01247974|O1|Outcome|CorMatrix ECM for Pericardial Closure|Pericardial closure with CorMatrix ECM
299969|NCT01247974|E2|Reported Event|Control|Pericardium is not closed
299970|NCT01247974|E1|Reported Event|CorMatrix ECM|CorMatrix ECM for Pericardial Closure
299971|NCT01247922|B1|Baseline|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
299972|NCT01247922|P1|Participant Flow|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
299973|NCT01247922|O1|Outcome|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
299974|NCT01247922|O1|Outcome|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
299975|NCT01247922|O1|Outcome|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
299976|NCT01247922|E1|Reported Event|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
299977|NCT01247675|B5|Baseline|Total|Total of all reporting groups
299978|NCT01247675|B4|Baseline|Omnitrope, 0.04 mg hGH/kg/wk|Human Growth Hormone: s.c., daily injection equivalent to 0.04 mg hGH/kg/wk for 4 weeks
299979|NCT01247675|B3|Baseline|ACP-001, 0.08 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.08 mg hGH/kg/wk for 4 weeks
299980|NCT01247675|B2|Baseline|ACP-001, 0.04 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.04 mg hGH/kg/wk for 4 weeks
299981|NCT01247675|B1|Baseline|ACP-001, 0.02 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.02 mg hGH/kg/wk for 4 weeks
299982|NCT01247675|P4|Participant Flow|Omnitrope, 0.04 mg hGH/kg/wk|Human Growth Hormone: subcutaneous, daily injection of Omnitrope equivalent to 0.04 mg/kg/wk over 4 weeks. Prior to randomization, study subjects entered a wash out period of 14 to 21 days following cessation of daily growth hormone therapy.
299983|NCT01247675|P3|Participant Flow|ACP-001, 0.08 mg hGH/kg/wk|ACP-001 (TransCon hGH): subcutaneous, weekly injection equivalent to 0.08 mg hGH/kg/wk over 4 weeks. Prior to randomization, study subjects entered a 14 to 21 day wash out period following cessation of daily growth hormone therapy.
299984|NCT01247675|P2|Participant Flow|ACP-001, 0.04 mg hGH/kg/wk|ACP-001 (TransCon hGH): subcutaneous, weekly injection equivalent to 0.04 mg hGH/kg/wk over 4 weeks. Prior to randomization, study subjects entered a 14 to 21 day wash out period following cessation of daily growth hormone therapy.
299985|NCT01247675|P1|Participant Flow|ACP-001, 0.02 mg hGH/kg/wk|ACP-001 (TransCon hGH): subcutaneous, weekly injection equivalent to 0.02 mg hGH/kg/wk over 4 weeks. Prior to randomization, study subjects entered a 14 to 21 day wash out period following cessation of daily growth hormone therapy.
299986|NCT01247675|O4|Outcome|Omnitrope, 0.04 mg hGH/kg/wk|Human Growth Hormone: s.c., daily injection of Omnitrope equivalent to 0.04 mg hGH/kg/wk for 4 weeks
299987|NCT01247675|O3|Outcome|ACP-001, 0.08 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.08 mg hGH/kg/wk
299988|NCT01247675|O2|Outcome|ACP-001, 0.04 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.04 mg hGH/kg/wk
299989|NCT01247675|O1|Outcome|ACP-001, 0.02 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.02 mg hGH/kg/wk for 4 weeks
299990|NCT01247675|O4|Outcome|Omnitrope, 0.04 mg hGH/kg/wk|Human Growth Hormone: s.c., daily injection of Omnitrope equivalent to 0.04 mg hGH/kg/wk for 4 weeks
299991|NCT01247675|O3|Outcome|ACP-001, 0.08 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.08 mg hGH/kg/wk for 4 weeks
299992|NCT01247675|O2|Outcome|ACP-001, 0.04 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.04 mg hGH/kg/wk for 4 weeks
299993|NCT01247675|O1|Outcome|ACP-001, 0.02 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.02 mg hGH/kg/wk for 4 weeks
299994|NCT01247675|O4|Outcome|Omnitrope, 0.04 mg hGH/kg/wk|Human Growth Hormone: s.c., daily injection of Omnitrope equivalent to 0.04 mg hGH/kg/wk for 4 weeks
299995|NCT01247675|O3|Outcome|ACP-001, 0.08 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.08 mg hGH/kg/wk for 4 weeks
299996|NCT01247675|O2|Outcome|ACP-001, 0.04 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.04 mg hGH/kg/wk for 4 weeks
299997|NCT01247675|O1|Outcome|ACP-001, 0.02 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.02 mg hGH/kg/wk for 4 weeks
299998|NCT01247675|O4|Outcome|Omnitrope, 0.04 mg hGH/kg/wk|Human Growth Hormone: s.c., daily injection of Omnitrope equivalent to 0.04 mg hGH/kg/wk for 4 weeks
299999|NCT01247675|O3|Outcome|ACP-001, 0.08 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.08 mg hGH/kg/wk for 4 weeks
300000|NCT01247675|O2|Outcome|ACP-001, 0.04 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.04 mg hGH/kg/wk for 4 weeks
300001|NCT01247675|O1|Outcome|ACP-001, 0.02 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.02 mg hGH/kg/wk for 4 weeks
300002|NCT01247675|E4|Reported Event|Omnitrope, 0.04 mg hGH/kg/wk|Human Growth Hormone: s.c., daily injection of Omnitrope equivalent to 0.04 mg hGH/kg/wk for 4 weeks
300003|NCT01247675|E3|Reported Event|ACP-001, 0.08 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.08 mg hGH/kg/wk
300004|NCT01247675|E2|Reported Event|ACP-001, 0.04 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.04 mg hGH/kg/wk for 4 weeks
300005|NCT01247675|E1|Reported Event|ACP-001, 0.02 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.02 mg hGH/kg/wk for 4 weeks
300206|NCT01247064|B3|Baseline|Total|Total of all reporting groups
300006|NCT01247571|B1|Baseline|Pazopanib|Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
300007|NCT01247571|P1|Participant Flow|Pazopanib|Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
300008|NCT01247571|O1|Outcome|Pazopanib|Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
300009|NCT01247571|O1|Outcome|Pazopanib|Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
300010|NCT01247571|O1|Outcome|Pazopanib|Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
300011|NCT01247571|O1|Outcome|Pazopanib|Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
300012|NCT01247571|O1|Outcome|Pazopanib|Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
300013|NCT01247571|E1|Reported Event|Pazopanib|Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
300014|NCT01247428|B1|Baseline|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
300015|NCT01247428|P1|Participant Flow|MiStent SES|The MiStent SES is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
300016|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
300017|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
300018|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
300019|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
300020|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
300021|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
300022|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
300023|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
300024|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
300025|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
300026|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
300027|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
300028|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
300029|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
300030|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
300031|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
300032|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
300033|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
300034|NCT01247428|E1|Reported Event|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
300035|NCT01247350|B6|Baseline|Total|Total of all reporting groups
300036|NCT01247350|B5|Baseline|Placebo|administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days (multiple dose)
300037|NCT01247350|B4|Baseline|14 mg LY3009104|14 mg administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days (multiple dose)
300038|NCT01247350|B3|Baseline|10 mg LY3009104|10 mg administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days ((multiple dose)
300039|NCT01247350|B2|Baseline|5 mg LY3009104|5 mg administered orally once on Day 1 (single dose)
300040|NCT01247350|B1|Baseline|2 mg LY3009104|2 mg administered orally once on Day 1 (single dose)
300041|NCT01247350|P5|Participant Flow|Placebo|administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days (multiple dose)
300042|NCT01247350|P4|Participant Flow|14 mg LY3009104|14 mg administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days (multiple dose)
300043|NCT01247350|P3|Participant Flow|10 mg LY3009104|10 mg administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days ((multiple dose)
300044|NCT01247350|P2|Participant Flow|5 mg LY3009104|5 mg administered orally once on Day 1 (single dose)
300045|NCT01247350|P1|Participant Flow|2 mg LY3009104 (Baricitinib)|2 mg administered orally once on Day 1 (single dose)
300048|NCT01247350|O6|Outcome|14 mg LY3009104 Day 17|Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
300049|NCT01247350|O5|Outcome|10 mg LY3009104 Day 17|Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
300050|NCT01247350|O4|Outcome|14 mg LY3009104 Day 1|14 mg administered orally once on Day 1
300051|NCT01247350|O3|Outcome|10 mg LY3009104 Day 1|10 mg administered orally once on Day 1
300052|NCT01247350|O2|Outcome|5 mg LY3009104 Day 1|5 mg administered orally once on Day 1
300053|NCT01247350|O1|Outcome|2 mg LY3009104 Day 1|2 mg administered orally once on Day 1
300054|NCT01247350|O6|Outcome|14 mg LY3009104 Day 17|Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
300055|NCT01247350|O5|Outcome|10 mg LY3009104 Day 17|Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
300056|NCT01247350|O4|Outcome|14 mg LY3009104 Day 1|14 mg administered orally once on Day 1
300057|NCT01247350|O3|Outcome|10 mg LY3009104 Day 1|10 mg administered orally once on Day 1
300058|NCT01247350|O2|Outcome|5 mg LY3009104 Day 1|5 mg administered orally once on Day 1
300059|NCT01247350|O1|Outcome|2 mg LY3009104 Day 1|2 mg administered orally once on Day 1
300060|NCT01247350|O6|Outcome|14 mg LY3009104 Day 17|Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
300061|NCT01247350|O5|Outcome|10 mg LY3009104 Day 17|Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
300062|NCT01247350|O4|Outcome|14 mg LY3009104 Day 1|14 mg administered orally once on Day 1
300063|NCT01247350|O3|Outcome|10 mg LY3009104 Day 1|10 mg administered orally once on Day 1
300064|NCT01247350|O2|Outcome|5 mg LY3009104 Day 1|5 mg administered orally once on Day 1
300065|NCT01247350|O1|Outcome|2 mg LY3009104 Day 1|2 mg administered orally once on Day 1
300066|NCT01247350|O6|Outcome|14 mg LY3009104 Day 17|Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
300067|NCT01247350|O5|Outcome|10 mg LY3009104 Day 17|Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
300068|NCT01247350|O4|Outcome|14 mg LY3009104 Day 1|14 mg administered orally once on Day 1
300069|NCT01247350|O3|Outcome|10 mg LY3009104 Day 1|10 mg administered orally once on Day 1
300070|NCT01247350|O2|Outcome|5 mg LY3009104 Day 1|5 mg administered orally once on Day 1
300071|NCT01247350|O1|Outcome|2 mg LY3009104 Day 1|2 mg administered orally once on Day 1
300072|NCT01247350|O6|Outcome|14 mg LY3009104 Day 17|Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
300073|NCT01247350|O5|Outcome|10 mg LY3009104 Day 17|Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
300074|NCT01247350|O4|Outcome|14 mg LY3009104 Day 1|14 mg administered orally once on Day 1
300075|NCT01247350|O3|Outcome|10 mg LY3009104 Day 1|10 mg administered orally once on Day 1
300076|NCT01247350|O2|Outcome|5 mg LY3009104 Day 1|5 mg administered orally once on Day 1
300077|NCT01247350|O1|Outcome|2 mg LY3009104 Day 1|2 mg administered orally once on Day 1
300078|NCT01247350|O6|Outcome|14 mg LY3009104 Day 17|Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
300079|NCT01247350|O5|Outcome|10 mg LY3009104 Day 17|Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
300080|NCT01247350|O4|Outcome|14 mg LY3009104 Day 1|14 mg administered orally once on Day 1
300081|NCT01247350|O3|Outcome|10 mg LY3009104 Day 1|10 mg administered orally once on Day 1
300082|NCT01247350|O2|Outcome|5 mg LY3009104 Day 1|5 mg administered orally once on Day 1
300083|NCT01247350|O1|Outcome|2 mg LY3009104 Day 1|2 mg administered orally once on Day 1
300084|NCT01247350|O8|Outcome|Placebo Multiple Dose|Following a 7-day washout period, participants in the placebo single-dose group received placebo once daily for 10 days.
300085|NCT01247350|O7|Outcome|14 mg LY3009104 Multiple Dose|Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
300086|NCT01247350|O6|Outcome|10 mg LY3009104 Multiple Dose|Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
300087|NCT01247350|O5|Outcome|Placebo Single Dose|administered orally once on Day 1
300088|NCT01247350|O4|Outcome|14 mg LY3009104 Single Dose|14 mg administered orally once on Day 1
300089|NCT01247350|O3|Outcome|10 mg LY3009104 Single Dose|10 mg administered orally once on Day 1
300090|NCT01247350|O2|Outcome|5 mg LY3009104 Single Dose|5 mg administered orally once on Day 1
300091|NCT01247350|O1|Outcome|2 mg LY3009104 Single Dose|2 mg administered orally once on Day 1
300092|NCT01247350|E8|Reported Event|Placebo - Multiple Dose|Following a 7-day washout period, participants in the placebo single-dose group received placebo once daily for 10 days.
300093|NCT01247350|E7|Reported Event|14 mg LY3009104 - Multiple Dose|Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
300094|NCT01247350|E6|Reported Event|10 mg LY3009104 - Multiple Dose|Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
300095|NCT01247350|E5|Reported Event|Placebo - Single Dose|administered orally on Day 1
300096|NCT01247350|E4|Reported Event|14 mg LY3009104 - Single Dose|14 mg administered orally on Day 1
300097|NCT01247350|E3|Reported Event|10 mg LY3009104 - Single Dose|10 mg administered orally on Day 1
300098|NCT01247350|E2|Reported Event|5 mg LY3009104 - Single Dose|5 mg administered orally once on Day 1
300099|NCT01247350|E1|Reported Event|2 mg LY3009104 - Single Dose|2 mg administered orally once on Day 1
300101|NCT01247324|B2|Baseline|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
300102|NCT01247324|B1|Baseline|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
300103|NCT01247324|P2|Participant Flow|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
300104|NCT01247324|P1|Participant Flow|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
300105|NCT01247324|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
300106|NCT01247324|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
300107|NCT01247324|O1|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
300108|NCT01247324|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
300109|NCT01247324|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
300110|NCT01247324|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
300111|NCT01247324|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
300112|NCT01247324|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
300113|NCT01247324|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
300114|NCT01247324|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
300115|NCT01247324|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
300116|NCT01247324|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
300117|NCT01247324|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
300118|NCT01247324|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
300119|NCT01247324|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
300120|NCT01247324|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
300121|NCT01247324|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
300122|NCT01247324|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
300123|NCT01247324|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
300124|NCT01247324|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
300125|NCT01247324|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
300126|NCT01247324|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
300127|NCT01247324|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
300128|NCT01247324|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
300129|NCT01247324|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
300160|NCT01247285|E1|Reported Event|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
300130|NCT01247324|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
300131|NCT01247324|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
300132|NCT01247324|E2|Reported Event|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
300133|NCT01247324|E1|Reported Event|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
300134|NCT01247298|B1|Baseline|TACE + SBRT|"Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy.~Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin."
300135|NCT01247298|P1|Participant Flow|TACE + SBRT|"Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy.~Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin."
300136|NCT01247298|O1|Outcome|TACE + SBRT|"Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy.~Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin."
300137|NCT01247298|O1|Outcome|TACE + SBRT|"Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy.~Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin."
300138|NCT01247298|O1|Outcome|TACE + SBRT|"Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy.~Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin."
300139|NCT01247298|O1|Outcome|Stereotactic Body Radiation Therapy (SBRT)|"Patients will receive stereotactic body radiation therapy (SBRT) which is 3 radiation treatments at 15 Gy, for a total of 45 Gy. Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. (TACE is not performed as part of this clinical study, even though it is part of the inclusion criteria.)~Stereotactic Body Radiation Therapy (SBRT): This investigational study will evaluate the combination of TACE along with high dose SBRT. TACE has been used extensively in the palliative treatment of hepatocellular carcinoma (HCC). It will be performed by the Interventional Radiologist prior to radiation therapy."
300140|NCT01247298|O1|Outcome|TACE + SBRT|"Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy.~Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin."
300141|NCT01247298|E1|Reported Event|TACE + SBRT|"Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy.~Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin."
300142|NCT01247285|B3|Baseline|Total|Total of all reporting groups
300143|NCT01247285|B2|Baseline|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
300144|NCT01247285|B1|Baseline|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Hydrochloride Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
300145|NCT01247285|P2|Participant Flow|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
300146|NCT01247285|P1|Participant Flow|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Hydrochloride Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
300147|NCT01247285|O2|Outcome|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in first either period.
300148|NCT01247285|O1|Outcome|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
300149|NCT01247285|O2|Outcome|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in first either period.
300150|NCT01247285|O1|Outcome|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
300151|NCT01247285|O2|Outcome|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in first either period.
300152|NCT01247285|O1|Outcome|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
300153|NCT01247285|O2|Outcome|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in first either period.
300154|NCT01247285|O1|Outcome|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
300155|NCT01247285|O2|Outcome|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in first either period.
300156|NCT01247285|O1|Outcome|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
300157|NCT01247285|O2|Outcome|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in first either period.
300158|NCT01247285|O1|Outcome|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
300159|NCT01247285|E2|Reported Event|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in either period.
300161|NCT01247272|B3|Baseline|Total|Total of all reporting groups
300162|NCT01247272|B2|Baseline|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
300163|NCT01247272|B1|Baseline|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
300164|NCT01247272|P2|Participant Flow|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
300165|NCT01247272|P1|Participant Flow|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
300166|NCT01247272|O2|Outcome|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
300167|NCT01247272|O1|Outcome|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
300168|NCT01247272|O2|Outcome|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
300169|NCT01247272|O1|Outcome|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
300170|NCT01247272|O2|Outcome|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
300171|NCT01247272|O1|Outcome|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
300172|NCT01247272|O2|Outcome|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
300173|NCT01247272|O1|Outcome|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
300174|NCT01247272|O2|Outcome|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
300175|NCT01247272|O1|Outcome|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
300176|NCT01247272|O2|Outcome|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
300177|NCT01247272|O1|Outcome|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
300178|NCT01247272|E2|Reported Event|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
300179|NCT01247272|E1|Reported Event|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
300180|NCT01247220|B3|Baseline|Total|Total of all reporting groups
300181|NCT01247220|B2|Baseline|Ranibizumab|"Ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
300182|NCT01247220|B1|Baseline|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg~Peripheral Laser: Angiography-directed peripheral laser"
300183|NCT01247220|P2|Participant Flow|Ranibizumab|"Ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
300184|NCT01247220|P1|Participant Flow|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg~Peripheral Laser: Angiography-directed peripheral laser"
300185|NCT01247220|O2|Outcome|Ranibizumab|"Ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
300186|NCT01247220|O1|Outcome|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg~Peripheral Laser: Angiography-directed peripheral laser"
300187|NCT01247220|O2|Outcome|Ranibizumab|"Ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
300188|NCT01247220|O1|Outcome|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg~Peripheral Laser: Angiography-directed peripheral laser"
300189|NCT01247220|O2|Outcome|Ranibizumab|"Ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
300190|NCT01247220|O1|Outcome|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg~Peripheral Laser: Angiography-directed peripheral laser"
300191|NCT01247220|E2|Reported Event|Ranibizumab|"Ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
300192|NCT01247220|E1|Reported Event|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg~Peripheral Laser: Angiography-directed peripheral laser"
300193|NCT01247090|B4|Baseline|Total|Total of all reporting groups
300194|NCT01247090|B3|Baseline|Placebo|No Dose - Placebo Comparator
300195|NCT01247090|B2|Baseline|Low Dose|Low Dose: Active Comparator 0.30 mU per kg per minute
300196|NCT01247090|B1|Baseline|Very Low Dose|Very Low Dose: Active Comparator 0.15 mU per kg per minute
300197|NCT01247090|P3|Participant Flow|Placebo|No Dose - Placebo Comparator
300198|NCT01247090|P2|Participant Flow|Low Dose|Low Dose: Active Comparator 0.30 mU per kg per minute
300199|NCT01247090|P1|Participant Flow|Very Low Dose|Very Low Dose: Active Comparator 0.15 mU per kg per minute
300200|NCT01247090|O3|Outcome|Placebo|No Dose - Placebo Comparator
300201|NCT01247090|O2|Outcome|Low Dose|Low Dose: Active Comparator 0.30 mU per kg per minute
300202|NCT01247090|O1|Outcome|Very Low Dose|Very Low Dose: Active Comparator 0.15 mU per kg per minute
300207|NCT01247064|B2|Baseline|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
300208|NCT01247064|B1|Baseline|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
300209|NCT01247064|P2|Participant Flow|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
300210|NCT01247064|P1|Participant Flow|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
300211|NCT01247064|O2|Outcome|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
300212|NCT01247064|O1|Outcome|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
300213|NCT01247064|O2|Outcome|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
300214|NCT01247064|O1|Outcome|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
300215|NCT01247064|O2|Outcome|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
300216|NCT01247064|O1|Outcome|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
300217|NCT01247064|O2|Outcome|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
300218|NCT01247064|O1|Outcome|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
300219|NCT01247064|O2|Outcome|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
300220|NCT01247064|O1|Outcome|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
300221|NCT01247064|E2|Reported Event|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
300222|NCT01247064|E1|Reported Event|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
300223|NCT01246999|B5|Baseline|Total|Total of all reporting groups
300224|NCT01246999|B4|Baseline|LAIV - TIV|LAIV will be given followed by TIV 28 days later
300225|NCT01246999|B3|Baseline|TIV - TIV|TIV will be given followed by TIV 28 days later
300226|NCT01246999|B2|Baseline|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
300227|NCT01246999|B1|Baseline|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
300228|NCT01246999|P4|Participant Flow|TIV - TIV|TIV will be given IM followed by TIV IM
300229|NCT01246999|P3|Participant Flow|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
300230|NCT01246999|P2|Participant Flow|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
300231|NCT01246999|P1|Participant Flow|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
300232|NCT01246999|O4|Outcome|TIV - TIV|TIV will be given IM followed by TIV IM
300233|NCT01246999|O3|Outcome|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
300234|NCT01246999|O2|Outcome|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
300235|NCT01246999|O1|Outcome|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
300236|NCT01246999|O4|Outcome|TIV - TIV|TIV will be given IM followed by TIV IM
300237|NCT01246999|O3|Outcome|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
300238|NCT01246999|O2|Outcome|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
300239|NCT01246999|O1|Outcome|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
300240|NCT01246999|O4|Outcome|TIV - TIV|TIV will be given IM followed by TIV IM
300241|NCT01246999|O3|Outcome|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
300242|NCT01246999|O2|Outcome|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
300243|NCT01246999|O1|Outcome|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
300244|NCT01246999|O4|Outcome|TIV - TIV|TIV will be given IM followed by TIV IM
300245|NCT01246999|O3|Outcome|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
300246|NCT01246999|O2|Outcome|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
300247|NCT01246999|O1|Outcome|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
300248|NCT01246999|O4|Outcome|TIV - TIV|TIV will be given IM followed by TIV IM
300249|NCT01246999|O3|Outcome|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
300250|NCT01246999|O2|Outcome|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
300251|NCT01246999|O1|Outcome|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
300252|NCT01246999|O4|Outcome|TIV - TIV|TIV will be given IM followed by TIV IM
300253|NCT01246999|O3|Outcome|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
300254|NCT01246999|O2|Outcome|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
300255|NCT01246999|O1|Outcome|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
300256|NCT01246999|O3|Outcome|All First Dose Live Vaccine|All subjects who received LAIV as a first dose
300257|NCT01246999|O2|Outcome|Seasonal Influenza Vaccine (TIV-LAIV)|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
300258|NCT01246999|O1|Outcome|Trivalent Seasonal Live Attenuated Influenza Vaccine|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
300259|NCT01246999|E4|Reported Event|TIV-TIV|TIV will be given IM followed by IV IM
300260|NCT01246999|E3|Reported Event|LAIV-TIV|LAIV will be given intranasally followed by TIV intramuscularly
300261|NCT01246999|E2|Reported Event|TIV-LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
300262|NCT01246999|E1|Reported Event|LAIV-LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
300263|NCT01246973|B3|Baseline|Total|Total of all reporting groups
300264|NCT01246973|B2|Baseline|Placebo|"4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week~Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week"
300265|NCT01246973|B1|Baseline|Curcumin|"4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week~Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week"
300266|NCT01246973|P2|Participant Flow|Placebo|"4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week~Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week"
300267|NCT01246973|P1|Participant Flow|Curcumin|"4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week~Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week"
300268|NCT01246973|O2|Outcome|Placebo|"4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week~Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week"
300269|NCT01246973|O1|Outcome|Curcumin|"4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week~Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week"
300270|NCT01246973|O2|Outcome|Placebo|"4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week~Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week"
300271|NCT01246973|O1|Outcome|Curcumin|"4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week~Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week"
300272|NCT01246973|E2|Reported Event|Placebo|"4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week~Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week"
306247|NCT01229228|E4|Reported Event|Naprosyn 500 mg|
300273|NCT01246973|E1|Reported Event|Curcumin|"4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week~Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week"
300274|NCT01246960|B3|Baseline|Total|Total of all reporting groups
300275|NCT01246960|B2|Baseline|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
300276|NCT01246960|B1|Baseline|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
300277|NCT01246960|P2|Participant Flow|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin 85 mg/m^2~Leucovorin 400 mg/m^2~5-FU 400 mg/m^2 bolus~5-FU 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
300278|NCT01246960|P1|Participant Flow|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 milligrams per kilogram (mg/kg) intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering modified FOLFOX6 (mFOLFOX6).~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin 85 milligrams per square meter (mg/m^2)~Leucovorin 400 mg/m^2~5-Fluorouracil (5-FU) 400 mg/m^2 bolus~5-FU 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
300279|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
300280|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
300281|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
300282|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
300283|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
300284|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
300285|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
300313|NCT01246791|P1|Participant Flow|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
300412|NCT01246011|O3|Outcome|Heparin PF4 Antibody Negative|Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication
300286|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
300287|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
300288|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
300289|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
300290|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
300291|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
300292|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
300293|NCT01246960|E2|Reported Event|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
300294|NCT01246960|E1|Reported Event|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
300295|NCT01246895|B3|Baseline|Total|Total of all reporting groups
300296|NCT01246895|B2|Baseline|Control|Microfracture without BST-CarGel
300297|NCT01246895|B1|Baseline|Experimental|Microfracture with BST-CarGel
300298|NCT01246895|P2|Participant Flow|Microfracture Alone|Microfracture without BST-CarGel
300299|NCT01246895|P1|Participant Flow|Microfracture + BST-CarGel|Microfracture with BST-CarGel
300300|NCT01246895|O2|Outcome|Control|Microfracture without BST-CarGel
300301|NCT01246895|O1|Outcome|Expiremental|Microfracture with BST-CarGel
300302|NCT01246895|O2|Outcome|Microfracture Alone|Microfracture without BST-CarGel
300303|NCT01246895|O1|Outcome|Microfracture + BST-CarGel|Microfracture with BST-CarGel
300304|NCT01246895|O2|Outcome|Microfracture Alone|Microfracture without BST-CarGel
300305|NCT01246895|O1|Outcome|Microfracture + BST-CarGel|Microfracture with BST-CarGel
300306|NCT01246895|O2|Outcome|Microfracture Alone|Microfracture without BST-CarGel
300307|NCT01246895|O1|Outcome|Microfracture + BST-CarGel|Microfracture with BST-CarGel
300308|NCT01246895|O2|Outcome|Microfracture Alone|Microfracture without BST-CarGel
300309|NCT01246895|O1|Outcome|Microfracture + BST-CarGel|Microfracture with BST-CarGel
300310|NCT01246895|E2|Reported Event|Microfracture Alone|Microfracture without BST-CarGel
300311|NCT01246895|E1|Reported Event|Microfracture + BST-CarGel|Microfracture with BST-CarGel
300312|NCT01246791|B1|Baseline|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
301105|NCT01244529|E1|Reported Event|All Arms, All Interventions|All subjects wore all intervention throughout the course of the study.
300314|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
300315|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
300316|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
300317|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
300318|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
300319|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
300320|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
300321|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
300322|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
300323|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
300324|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
300325|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
300326|NCT01246791|E1|Reported Event|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
300327|NCT01246713|B1|Baseline|All Study Participants|All study participants received a 15mg/kg dose of a solid acetaminophen formulation and a 15mg/kg dose of a liquid acetaminophen formulation separated by at least a 2 week washout period.
300328|NCT01246713|P2|Participant Flow|Liquid Acetaminophen First, Then Solid Acetaminophen|Study participants randomized to receive liquid formulation first. They received a 15mg/kg dose of a liquid acetaminophen formulation for pharmacokinetic sampling on first study day, then had at least a 2 week washout period, then received a 15mg/kg dose of a solid acetaminophen formulation for pharmacokinetic sampling on subsequent study day.
300329|NCT01246713|P1|Participant Flow|Solid Acetaminophen First, Then Liquid Acetaminophen|Study participants randomized to receive solid formulation first. They received a 15mg/kg dose of a solid acetaminophen formulation for pharmacokinetic sampling on first study day, then had at least a 2 week washout period, then received a 15mg/kg dose of a liquid acetaminophen formulation for pharmacokinetic sampling on subsequent study day.
300330|NCT01246713|O2|Outcome|Acetaminophen Liquid Formulation|Subjects in this arm will receive a 15mg/kg dose of a liquid acetaminophen formulation. Results for APAP-cysteinate metabolite
300331|NCT01246713|O1|Outcome|Acetaminophen Solid Formulation|Subjects in this arm will receive a 15mg/kg dose of a solid acetaminophen formulation. Results for APAP-cysteinate metabolite
300332|NCT01246713|E2|Reported Event|Liquid Acetaminophen First, Then Solid Acetaminophen|Participants in arm Liquid Acetaminophen First: received a single 15mg/kg dose of a liquid acetaminophen formulation, and then a 15mg/kg dose of a solid acetaminophen formulation after a 2 week washout period.
300333|NCT01246713|E1|Reported Event|Solid Acetaminophen First, Then Liquid Acetaminophen|Participants in arm Solid Acetaminophen First: received a single 15mg/kg dose of a solid acetaminophen formulation first, and then a 15mg/kg dose of a liquid acetaminophen formulation after a 2 week washout period.
300334|NCT01246479|B1|Baseline|No Treatment|"subjects will be followed up on immunity (analysis of blood samples) and safety~Blood draw: blood draw at Month 12, Month 24 and Month 36.~IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322."
300335|NCT01246479|P1|Participant Flow|No Treatment|"subjects will be followed up on immunity (analysis of blood samples) and safety~Blood draw: blood draw at Month 12, Month 24 and Month 36.~IC51 has given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322."
300336|NCT01246479|O1|Outcome|No Treatment|"subjects will be followed up on immunity (analysis of blood samples) and safety~Blood draw: blood draw at Month 12, Month 24 and Month 36.~IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322."
300337|NCT01246479|E1|Reported Event|No Treatment|"subjects will be followed up on immunity (analysis of blood samples) and safety~Blood draw: blood draw at Month 12, Month 24 and Month 36.~IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322."
300338|NCT01246401|B3|Baseline|Total|Total of all reporting groups
300339|NCT01246401|B2|Baseline|Placebo|"Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
300340|NCT01246401|B1|Baseline|Extended-Release Naltrexone|"Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
300409|NCT01246011|P3|Participant Flow|Heparin PF4 Antibody Negative|Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication
301106|NCT01244516|B4|Baseline|Total|Total of all reporting groups
300341|NCT01246401|P2|Participant Flow|Placebo|"Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
300342|NCT01246401|P1|Participant Flow|Extended-Release Naltrexone|"Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
300343|NCT01246401|O2|Outcome|4 or More XR-NTX Injections|All participants who received 4 or more XR-NTX injections
300344|NCT01246401|O1|Outcome|Placebo + Participants With 3 or Fewer XR-NTX Injections|All participants receiving Placebo as well as participants who received 3 or less XR-NTX injections
300345|NCT01246401|O2|Outcome|4 or More XR-NTX Injections|All participants who received 4 or more XR-NTX injections
300346|NCT01246401|O1|Outcome|Placebo + Participants With 3 or Fewer XR-NTX Injections|All participants receiving Placebo as well as participants who received 3 or less XR-NTX injections
300347|NCT01246401|O2|Outcome|Placebo|"Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
300348|NCT01246401|O1|Outcome|Extended-Release Naltrexone|"Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
300349|NCT01246401|O2|Outcome|Placebo|"Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
300350|NCT01246401|O1|Outcome|Extended-Release Naltrexone|"Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
300351|NCT01246401|O2|Outcome|Placebo|"Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
300352|NCT01246401|O1|Outcome|Extended-Release Naltrexone|"Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
300353|NCT01246401|O2|Outcome|Placebo|"Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
300354|NCT01246401|O1|Outcome|Extended-Release Naltrexone|"Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
300355|NCT01246401|O2|Outcome|Placebo|"Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
300356|NCT01246401|O1|Outcome|Extended-Release Naltrexone|"Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
300357|NCT01246401|O2|Outcome|Placebo|"Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
300358|NCT01246401|O1|Outcome|Extended-Release Naltrexone|"Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
300359|NCT01246401|O2|Outcome|Placebo|"Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
300360|NCT01246401|O1|Outcome|Extended-Release Naltrexone|"Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
300361|NCT01246401|O2|Outcome|Placebo|"Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
300362|NCT01246401|O1|Outcome|Extended-Release Naltrexone|"Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
300363|NCT01246401|E2|Reported Event|Placebo|"Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
300364|NCT01246401|E1|Reported Event|Extended-Release Naltrexone|"Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release~Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
300365|NCT01246349|B3|Baseline|Total|Total of all reporting groups
300410|NCT01246011|P2|Participant Flow|Heparin PF4 Antibody Positive no Drug|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
306248|NCT01229228|E3|Reported Event|Naprosyn 250 mg|
300366|NCT01246349|B2|Baseline|Control (Social Skills Training)|"The control group received social skills training in place of Motivational Interviewing (MI). The social skills training was provided by a therapist who was not trained in MI to avoid cross-contamination.~The social skills training provided was a standardized and manualized treatment, developed and validated for children and adolescents. As part of this training, the interventionist offered advice and clients were assigned specific tasks to work on. No consideration of clients’ readiness to change was made in this group."
300367|NCT01246349|B1|Baseline|Treatment Group (Motivational Interviewing)|"The treatment group received Motivational Interviewing (MI), which is a client-centered, directive method of therapy aimed at enhancing a client’s intrinsic motivation to change by exploring and resolving ambivalence.~MI utilizes strategies to guide the patient, as opposed to offering advice or focusing on accomplishing specific goals. For example, using reflective listening and shared decision making are common within the MI approach.~Six individual MI sessions, approximately 30 minutes in length each, were provided by a trained clinical psychology doctoral student."
300368|NCT01246349|P2|Participant Flow|Treatment/Experimental Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.~A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
300369|NCT01246349|P1|Participant Flow|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.~The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients’ readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
300370|NCT01246349|O2|Outcome|Motivational Interviewing Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.~A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
300371|NCT01246349|O1|Outcome|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.~The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients’ readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
300372|NCT01246349|O2|Outcome|Motivational Interviewing Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.~A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
300373|NCT01246349|O1|Outcome|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.~The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients’ readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
300374|NCT01246349|O2|Outcome|Motivational Interviewing Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.~A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
300375|NCT01246349|O1|Outcome|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.~The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients’ readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
300376|NCT01246349|O2|Outcome|Motivational Interviewing Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.~A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
300377|NCT01246349|O1|Outcome|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.~The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients’ readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
300378|NCT01246349|E2|Reported Event|Motivational Interviewing Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.~A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
300379|NCT01246349|E1|Reported Event|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.~The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients’ readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
300380|NCT01246258|B1|Baseline|Test Group|Utricular centrifugation and VEMPs: Standard tests of balance function
300381|NCT01246258|P1|Participant Flow|Test Group|Utricular centrifugation and VEMPs: Standard tests of balance function
300382|NCT01246258|O1|Outcome|Test Group|"Standard tests of balance function~Vestibular evoked myogenic potentials (VEMPs): Standard test of balance function~Utricular centrifugation test: Standard test of balance function"
300383|NCT01246258|O1|Outcome|Test Group|VEMPs
300384|NCT01246258|E1|Reported Event|Test Group|Utricular centrifugation and VEMPs: Standard tests of balance function
300385|NCT01246206|B1|Baseline|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis~Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
300386|NCT01246206|P1|Participant Flow|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis~Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
300387|NCT01246206|O1|Outcome|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis~Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
300388|NCT01246206|O1|Outcome|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis~Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
300389|NCT01246206|O1|Outcome|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis~Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
300390|NCT01246206|O1|Outcome|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis~Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
300411|NCT01246011|P1|Participant Flow|Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
300391|NCT01246206|O1|Outcome|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis~Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
300392|NCT01246206|O1|Outcome|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis~Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
300393|NCT01246206|O1|Outcome|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis~Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
300394|NCT01246206|O1|Outcome|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis~Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
300395|NCT01246206|E1|Reported Event|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis~Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
300396|NCT01246076|B1|Baseline|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
300397|NCT01246076|P1|Participant Flow|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
300398|NCT01246076|O1|Outcome|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
300399|NCT01246076|O1|Outcome|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
300400|NCT01246076|O1|Outcome|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
300401|NCT01246076|O1|Outcome|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
300402|NCT01246076|O1|Outcome|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
300403|NCT01246076|O1|Outcome|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
300404|NCT01246076|E1|Reported Event|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
300405|NCT01246011|B4|Baseline|Total|Total of all reporting groups
300406|NCT01246011|B3|Baseline|Heparin PF4 Antibody Negative|Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication
300407|NCT01246011|B2|Baseline|Heparin PF4 Antibody Positive no Drug|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
300408|NCT01246011|B1|Baseline|Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
306249|NCT01229228|E2|Reported Event|Naproxen Test (Upper Dose)|
300413|NCT01246011|O2|Outcome|Heparin PF4 Antibody Positive no Drug|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
300414|NCT01246011|O1|Outcome|Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)|"Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin~Argatroban and warfarin: Subjects with the presence of heparin PF4 antibodies without signs or symptoms of HIT post CABG will be randomized to receive argatroban and warfarin or no drug for one month."
300415|NCT01246011|O3|Outcome|Heparin PF4 Antibody Negative|Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication
300416|NCT01246011|O2|Outcome|Heparin PF4 Antibody Positive no Drug|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
300417|NCT01246011|O1|Outcome|Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
300418|NCT01246011|E3|Reported Event|Heparin PF4 Antibody Negative|Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication
300419|NCT01246011|E2|Reported Event|Heparin PF4 Antibody Positive no Drug|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
300420|NCT01246011|E1|Reported Event|Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
300421|NCT01245764|B5|Baseline|Total|Total of all reporting groups
300422|NCT01245764|B4|Baseline|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B. Safety evaluation continued to Month 7 of study Phase B (total study duration up to 19 months)
300423|NCT01245764|B3|Baseline|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
300424|NCT01245764|B2|Baseline|GARDASIL 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
300425|NCT01245764|B1|Baseline|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
300426|NCT01245764|P4|Participant Flow|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B. Safety evaluation continued to Month 7 of study Phase B (total study duration up to 19 months)
300427|NCT01245764|P3|Participant Flow|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
300428|NCT01245764|P2|Participant Flow|GARDASIL 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
300429|NCT01245764|P1|Participant Flow|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
300430|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
300431|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
300432|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
300433|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
300434|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
300435|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
300436|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A.
300437|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A.
300438|NCT01245764|O4|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B. Safety evaluation continued to Month 7 of study Phase B (total study duration up to 19 months)
300439|NCT01245764|O3|Outcome|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation will continue to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
300440|NCT01245764|O2|Outcome|Placebo 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
301107|NCT01244516|B3|Baseline|Comfilcon A|Subjects that were randomized to wear comfilcon A lens throughout the course of the study.
300441|NCT01245764|O1|Outcome|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
300442|NCT01245764|O4|Outcome|Placebo 9 to 12 Years Old|Placebo to match GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
300443|NCT01245764|O3|Outcome|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
300444|NCT01245764|O2|Outcome|Placebo 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
300445|NCT01245764|O1|Outcome|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
300446|NCT01245764|O4|Outcome|Placebo 9 to 12 Years Old|Placebo to match GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
300447|NCT01245764|O3|Outcome|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
300448|NCT01245764|O2|Outcome|Placebo 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
300449|NCT01245764|O1|Outcome|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
300450|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
300451|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
300452|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
300453|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
300454|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
300455|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
300456|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A.
300457|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A.
300458|NCT01245764|E4|Reported Event|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B.
300459|NCT01245764|E3|Reported Event|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants did not continue to study Phase B.
300460|NCT01245764|E2|Reported Event|GARDASIL 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants did not continue to study Phase B.
300461|NCT01245764|E1|Reported Event|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants did not continue to study Phase B.
300462|NCT01245751|B5|Baseline|Total|Total of all reporting groups
300463|NCT01245751|B4|Baseline|Group 4: First Dose Participants ≥50 and <60 Years of Age|Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
300464|NCT01245751|B3|Baseline|Group 3: First Dose Participants ≥60 and <70 Years of Age|Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
300465|NCT01245751|B2|Baseline|Group 2: First Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
300466|NCT01245751|B1|Baseline|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
300467|NCT01245751|P4|Participant Flow|Group 4: First Dose Participants ≥50 and <60 Years of Age|Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
300468|NCT01245751|P3|Participant Flow|Group 3: First Dose Participants ≥60 and <70 Years of Age|Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
300469|NCT01245751|P2|Participant Flow|Group 2: First Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
300470|NCT01245751|P1|Participant Flow|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
300471|NCT01245751|O4|Outcome|Group 4: First Dose Participants ≥50 and <60 Years of Age|Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
300472|NCT01245751|O3|Outcome|Group 3: First Dose Participants ≥60 and <70 Years of Age|Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
300473|NCT01245751|O2|Outcome|Group 2: First Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
300474|NCT01245751|O1|Outcome|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004(NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
300475|NCT01245751|O1|Outcome|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004(NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
300476|NCT01245751|O2|Outcome|Group 2: First Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
300477|NCT01245751|O1|Outcome|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
300478|NCT01245751|E4|Reported Event|Group 4: First Dose Participants ≥50 and <60 Years of Age|Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
300479|NCT01245751|E3|Reported Event|Group 3: First Dose Participants ≥60 and <70 Years of Age|Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
300480|NCT01245751|E2|Reported Event|Group 2: First Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
300481|NCT01245751|E1|Reported Event|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
300482|NCT01245738|B1|Baseline|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
300483|NCT01245738|P1|Participant Flow|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
300484|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
300485|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
300486|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
300487|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
300488|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
300489|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
300490|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
300491|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
300492|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
300493|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
300494|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
300495|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
300496|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
300497|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
300498|NCT01245738|E1|Reported Event|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
300499|NCT01245647|B3|Baseline|Total|Total of all reporting groups
300500|NCT01245647|B2|Baseline|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
300501|NCT01245647|B1|Baseline|Sugar Pill, 50mg, Once a Day for 4 Months|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
300502|NCT01245647|P2|Participant Flow|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
300503|NCT01245647|P1|Participant Flow|Sugar Pill, 50mg, Once a Day for 4 Months.|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
300504|NCT01245647|O2|Outcome|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
300505|NCT01245647|O1|Outcome|Sugar Pill, 50mg, Once a Day for 4 Months.|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
300506|NCT01245647|O2|Outcome|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
300507|NCT01245647|O1|Outcome|Sugar Pill, 50mg, Once a Day for 4 Months.|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
306250|NCT01229228|E1|Reported Event|Naproxen Test (Lower Dose)|
300508|NCT01245647|O2|Outcome|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
300509|NCT01245647|O1|Outcome|Sugar Pill, 50mg, Once a Day for 4 Months.|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
300510|NCT01245647|O2|Outcome|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
300511|NCT01245647|O1|Outcome|Sugar Pill, 50mg, Once a Day for 4 Months.|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
300512|NCT01245647|O2|Outcome|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
300513|NCT01245647|O1|Outcome|Sugar Pill, 50mg, Once a Day for 4 Months.|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
300514|NCT01245647|E2|Reported Event|Naltrexone, 50mg Pill Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
300515|NCT01245647|E1|Reported Event|Sugar Pill, 50 mg Once a Day for 4 Months|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
300516|NCT01245595|B3|Baseline|Total|Total of all reporting groups
300517|NCT01245595|B2|Baseline|Placebo|"Normal Saline Placebo~Placebo: Normal Saline"
300518|NCT01245595|B1|Baseline|Aminophylline|"Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours~Aminophylline: 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours"
300519|NCT01245595|P2|Participant Flow|Placebo|"Normal Saline Placebo~Placebo: Normal Saline"
300520|NCT01245595|P1|Participant Flow|Aminophylline|"Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours~Aminophylline: 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours"
300521|NCT01245595|O2|Outcome|Placebo|"Normal Saline Placebo~Placebo: Normal Saline"
300522|NCT01245595|O1|Outcome|Aminophylline|"Patients to receive aminophylline 5 mg/kg intravenous (IV) bolus then 1.8 mg/kg IV every six (Q6) hours~Aminophylline: 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours"
300523|NCT01245595|E2|Reported Event|Placebo|"Normal Saline Placebo~Placebo: Normal Saline"
300524|NCT01245595|E1|Reported Event|Aminophylline|"Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours~Aminophylline: 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours"
300525|NCT01245439|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300526|NCT01245439|P1|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current Disease-modifying antirheumatic drugs (DMARDs) and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300527|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300528|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300529|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300530|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300531|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300532|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300533|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300534|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300581|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300535|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300536|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300537|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300538|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300539|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300540|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300541|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current Disease-modifying antirheumatic drugs (DMARDs) and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300542|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300543|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300544|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300545|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current (DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300546|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300547|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300548|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300549|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300550|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300551|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current Disease-modifying antirheumatic drugs (DMARDs) and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300552|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current Disease-modifying antirheumatic drugs (DMARDs) and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300582|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300553|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300554|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300555|NCT01245439|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
300556|NCT01245413|B1|Baseline|Entire Study Population|Entire study population = all participlants enrolled in the study
300557|NCT01245413|P2|Participant Flow|Athena Adhesive|Athena =the new test product. The Athena in this trails is an adhesive. The intend use is collecting output from a stoma (e.g an ileostomy and colostomy).
300558|NCT01245413|P1|Participant Flow|SenSura Adhesive|Sensura is an already commercially available baseplate. Designed to collect output from a stoma(e.g an ileostomy and colostomy).
300559|NCT01245413|O2|Outcome|Athena Adhesive|New test adhesive
300560|NCT01245413|O1|Outcome|SenSura Adhesive|Reference adhesive which is commercially available.
300561|NCT01245413|E2|Reported Event|Athena Adhesive|Base-plate adhesion to skin
300562|NCT01245413|E1|Reported Event|SenSura Adhesive|base-plate adhesion to skin
300563|NCT01245387|B1|Baseline|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300564|NCT01245387|P1|Participant Flow|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300565|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300566|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300567|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300568|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300569|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300570|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300571|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300572|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300573|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300574|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300575|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300576|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300577|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300578|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300579|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300580|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300727|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
306251|NCT01229176|B9|Baseline|Total|Total of all reporting groups
300583|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300584|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300585|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300586|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300587|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300588|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300589|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300590|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300591|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300592|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300593|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300594|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300595|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300596|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300597|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300598|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300599|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300600|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300601|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300602|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300603|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300604|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300605|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300606|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300607|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300608|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
306468|NCT01228591|O2|Outcome|Acuvue Advance|Acuvue Advance contact lenses worn.
300609|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300610|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300611|NCT01245387|E1|Reported Event|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
300612|NCT01245374|B1|Baseline|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
300613|NCT01245374|P1|Participant Flow|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
300614|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
300615|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
300616|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
300617|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
300618|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
300619|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
300620|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
300621|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
300622|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
300623|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
300624|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
300625|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
300626|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
300627|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
300628|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
300629|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
300630|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
300631|NCT01245374|E1|Reported Event|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
300632|NCT01245283|B4|Baseline|Total|Total of all reporting groups
300633|NCT01245283|B3|Baseline|Eccentric Focused RX (ERX)|"The Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while “assistance” is provided by the machine during the concentric phase. One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
300634|NCT01245283|B2|Baseline|Concentric Focused RX (CRX)|"Training protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
300728|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300729|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
300635|NCT01245283|B1|Baseline|Wait-list Non-exercise Control (CON)|"Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.~normal activities and clinical care: Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines"
300636|NCT01245283|P3|Participant Flow|Eccentric Focused RX (ERX)|"The Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while “assistance” is provided by the machine during the concentric phase. One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
300637|NCT01245283|P2|Participant Flow|Concentric Focused RX (CRX)|"Training protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
300638|NCT01245283|P1|Participant Flow|Wait-list Non-exercise Control (CON)|"Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.~normal activities and clinical care: Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines"
300639|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
300640|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
300641|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
300642|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
300643|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
300644|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
300645|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
300646|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
300647|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
300648|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
300649|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
300650|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
300651|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
300652|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
300653|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
300654|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
300655|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
300656|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
300730|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300657|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
300658|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
300659|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
300660|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
300661|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
300662|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
300663|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|"The Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while “assistance” is provided by the machine during the concentric phase. One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
300664|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|"Training protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
300665|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|"Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.~normal activities and clinical care: Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines"
300666|NCT01245283|E3|Reported Event|Eccentric Focused RX (ERX)|"The Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while “assistance” is provided by the machine during the concentric phase. One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
300667|NCT01245283|E2|Reported Event|Concentric Focused RX (CRX)|"Training protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
300668|NCT01245283|E1|Reported Event|Wait-list Non-exercise Control (CON)|"Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.~normal activities and clinical care: Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines"
300669|NCT01245270|B3|Baseline|Total|Total of all reporting groups
300670|NCT01245270|B2|Baseline|Control Capsule First, Then Bilberry Capsule|In a cross-over design, eight volunteers were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
300671|NCT01245270|B1|Baseline|Bilberry Capsule First, Then Control Capsule|In a cross-over design, eight volunteers were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
300731|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
300732|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300733|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
300672|NCT01245270|P2|Participant Flow|Single Bilberry Capsule First Then Control Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
300673|NCT01245270|P1|Participant Flow|Single Control Capsule First Then Bilberry Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
300674|NCT01245270|O2|Outcome|Single Bilberry Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
300675|NCT01245270|O1|Outcome|Single Control Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
300676|NCT01245270|O2|Outcome|Single Blaeberry Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
300677|NCT01245270|O1|Outcome|Single Placebo Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
300678|NCT01245270|E2|Reported Event|Single Placebo Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
300734|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300735|NCT01245140|E2|Reported Event|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
300736|NCT01245140|E1|Reported Event|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300737|NCT01245101|B3|Baseline|Total|Total of all reporting groups
300738|NCT01245101|B2|Baseline|Observation Then Raltegravir|Observation for 16 weeks followed by a washout of 8 weeks followed by Raltegravir 400mg twice a day for 16 weeks.
300739|NCT01245101|B1|Baseline|Raltegravir Then Observation|Raltegravir 400 mg twice a day for 16 weeks followed by a washout of 8 weeks followed by Observation of 16 weeks.
300679|NCT01245270|E1|Reported Event|Single Bilberry Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
300680|NCT01245140|B3|Baseline|Total|Total of all reporting groups
300681|NCT01245140|B2|Baseline|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
300682|NCT01245140|B1|Baseline|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300683|NCT01245140|P2|Participant Flow|Alitretinoin 30 mg|Participants received an alitretinoin 30 milligram (mg) capsule orally QD for up to 24 weeks.
300684|NCT01245140|P1|Participant Flow|Matching Placebo|Participants received matching placebo orally once daily (QD) for up to 24 weeks.
300685|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
300686|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300687|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
300688|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300689|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
300690|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300691|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
300692|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300693|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
300694|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300695|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
300696|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300697|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
300698|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300699|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
300700|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300701|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
300702|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300703|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
300704|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300705|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
300706|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300707|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
300708|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300709|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
300710|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300711|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
300712|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300713|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
300714|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300715|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
300716|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300717|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
300718|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300719|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
300720|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300721|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
300722|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300723|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
300724|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300725|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
300726|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
300740|NCT01245101|P2|Participant Flow|Observation Then Raltegravir|Observation for 16 weeks followed by a washout of 8 weeks followed by Raltegravir 400mg twice a day for 16 weeks.
300741|NCT01245101|P1|Participant Flow|Raltegravir Then Observation|Raltegravir 400 mg twice a day for 16 weeks followed by a washout of 8 weeks followed by Observation of 16 weeks.
300742|NCT01245101|O2|Outcome|Observation Then Raltegravir|Observation for 16 weeks followed by a washout of 8 weeks followed by Raltegravir 400mg twice a day for 16 weeks.
300743|NCT01245101|O1|Outcome|Raltegravir Then Observation|Raltegravir 400 mg twice a day for 16 weeks followed by a washout of 8 weeks followed by Observation of 16 weeks.
300744|NCT01245101|O2|Outcome|Observation Then Raltegravir|Observation for 16 weeks followed by a washout of 8 weeks followed by Raltegravir 400mg twice a day for 16 weeks.
300745|NCT01245101|O1|Outcome|Raltegravir Then Observation|Raltegravir 400 mg twice a day for 16 weeks followed by a washout of 8 weeks followed by Observation of 16 weeks.
300746|NCT01245101|E2|Reported Event|Observation|Observation for 16 weeks
300747|NCT01245101|E1|Reported Event|Raltegravir|Raltegravir 400 mg twice a day for 16 weeks
300748|NCT01245062|B3|Baseline|Total|Total of all reporting groups
300749|NCT01245062|B2|Baseline|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
300750|NCT01245062|B1|Baseline|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
300751|NCT01245062|P3|Participant Flow|Cross-over From Chemotherapy to Trametinib|Participants randomized to chemotherapy and who did not receive subsequent anti-cancer therapy after discontinuing chemotherapy were allowed to cross-over to Trametinib and received 2 mg tablet once daily until disease progression, death or withdrawal.
300752|NCT01245062|P2|Participant Flow|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
300753|NCT01245062|P1|Participant Flow|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
300754|NCT01245062|O1|Outcome|Cross-over From Chemotherapy to Trametinib|Participants randomized to chemotherapy and who did not receive subsequent anti-cancer therapy after discontinuing chemotherapy were allowed to cross-over to Trametinib and received 2 mg tablet once daily until disease progression, death or withdrawal.
300755|NCT01245062|O1|Outcome|Cross-over From Chemotherapy to Trametinib|Participants randomized to chemotherapy and who did not receive subsequent anti-cancer therapy after discontinuing chemotherapy were allowed to cross-over to Trametinib and received 2 mg tablet once daily until disease progression, death or withdrawal.
300756|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
300757|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
300758|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
300759|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
300760|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
300868|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
306469|NCT01228591|O1|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses worn.
300761|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
300762|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
300763|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
300764|NCT01245062|O1|Outcome|Cross-over From Chemotherapy to Trametinib|Participants randomized to chemotherapy and who did not receive subsequent anti-cancer therapy after discontinuing chemotherapy were allowed to cross-over to Trametinib and received 2 mg tablet once daily until disease progression, death or withdrawal.
300765|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
300766|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
300767|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
300768|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
300769|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
300770|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
300771|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
300772|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
300773|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
300774|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
300869|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
300870|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
301108|NCT01244516|B2|Baseline|Lotrafilcon B|Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.
300775|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
300776|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
300777|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
300778|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
300779|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
300780|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
300781|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
300782|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
300783|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
300784|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
300785|NCT01245062|E3|Reported Event|Cross-over From Chemotherapy to Trametinib|Participants randomized to chemotherapy and who did not receive subsequent anti-cancer therapy after discontinuing chemotherapy were allowed to cross-over to Trametinib and received 2 mg tablet once daily until disease progression, death or withdrawal.
300786|NCT01245062|E2|Reported Event|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
300787|NCT01245062|E1|Reported Event|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
300788|NCT01245049|B3|Baseline|Total|Total of all reporting groups
300789|NCT01245049|B2|Baseline|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
300871|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
300790|NCT01245049|B1|Baseline|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
300791|NCT01245049|P2|Participant Flow|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
300792|NCT01245049|P1|Participant Flow|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
300793|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
300794|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
300795|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
300796|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
300797|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
300798|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
300799|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
300800|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
300801|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
300872|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
300873|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
300802|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
300803|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
300804|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
300805|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
300806|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
300807|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
300808|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
300809|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
300810|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
300811|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
300812|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
300813|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
300874|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
300875|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
300814|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
300815|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
300816|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
300817|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
300818|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
300819|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
300820|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
300821|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
300822|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
300823|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
300824|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
300825|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
300876|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
300879|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
300826|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
300827|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
300828|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
300829|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
300830|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
300831|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
300832|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
300833|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
300834|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
300835|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
300836|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
300837|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
300877|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
300878|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
300838|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
300839|NCT01245049|E2|Reported Event|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
300840|NCT01245049|E1|Reported Event|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
300841|NCT01244984|B4|Baseline|Total|Total of all reporting groups
300842|NCT01244984|B3|Baseline|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
300843|NCT01244984|B2|Baseline|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
300844|NCT01244984|B1|Baseline|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
300845|NCT01244984|P3|Participant Flow|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
300846|NCT01244984|P2|Participant Flow|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
300847|NCT01244984|P1|Participant Flow|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg ) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
300848|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
300849|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
300850|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
300851|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
300852|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
300853|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
300854|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
300855|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
300856|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
300857|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
300858|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
300859|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
300860|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
300861|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
300862|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
300863|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
300864|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
300865|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
300866|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
300867|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
301009|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
300880|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
300881|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
300882|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
300883|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
300884|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
300885|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
300886|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
300887|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
300888|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
300889|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
300890|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
300891|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
300892|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
300893|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
300894|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
300895|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
300896|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
300897|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
300898|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
300899|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
300900|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
300901|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
300902|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
300903|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
300904|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
300905|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
300906|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
300907|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
300908|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
300909|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
300910|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
300911|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
300912|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
300913|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
300914|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
301010|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
300915|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
300916|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
300917|NCT01244984|E3|Reported Event|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
300918|NCT01244984|E2|Reported Event|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
300919|NCT01244984|E1|Reported Event|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
300920|NCT01244906|B1|Baseline|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
300921|NCT01244906|P1|Participant Flow|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
300922|NCT01244906|O1|Outcome|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
300923|NCT01244906|O1|Outcome|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
300924|NCT01244906|O1|Outcome|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
300925|NCT01244906|O1|Outcome|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
300926|NCT01244906|O1|Outcome|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
300927|NCT01244906|O1|Outcome|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
300928|NCT01244906|E1|Reported Event|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
300929|NCT01244893|B1|Baseline|All Subjects|Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn first and Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn second.
300930|NCT01244893|P2|Participant Flow|Acuvue Advance Plus postQ/Acuvue Advance Plus preQ|"Arm 1:~Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification will be worn first, then Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification will be worn second.~Arm 2:~Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification will be worn first, then Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification will be worn second."
300931|NCT01244893|P1|Participant Flow|Acuvue Advance Plus preQ/Acuvue Advance Plus postQ|"Arm 1:~Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn first, then Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn second.~Arm 2:~Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn first, then Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn second."
300932|NCT01244893|O2|Outcome|Acuvue Advance Plus postQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured post qualification were worn daily for 6-9 days.
300933|NCT01244893|O1|Outcome|Acuvue Advance Plus preQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-9 days.
300934|NCT01244893|O2|Outcome|Acuvue Advance Plus postQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured post qualification were worn daily for 6-8 days.
300935|NCT01244893|O1|Outcome|Acuvue Advance Plus preQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-8 days.
300936|NCT01244893|O2|Outcome|Acuvue Advance Plus postQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured post to qualification were worn daily for 6-8 days.
300937|NCT01244893|O1|Outcome|Acuvue Advance Plus preQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-8 days.
300938|NCT01244893|O2|Outcome|Acuvue Advance Plus postQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured post qualification were worn daily for 6-8 days. Binocular measurements reported only.
300939|NCT01244893|O1|Outcome|Acuvue Advance Plus preQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-8 days. Binocular measurements reported only.
300940|NCT01244893|E2|Reported Event|AAP PostQ|Acuvue Advance Plus silicone hydrogel contact lenses will be used both pre- / post-qualification.
300941|NCT01244893|E1|Reported Event|AAP PreQ|Acuvue Advance Plus silicone hydrogel contact lenses will be used both pre- / post-qualification.
300942|NCT01244828|B1|Baseline|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
300943|NCT01244828|P1|Participant Flow|Asenapine|All participants receive asenapine 5 mg twice daily (BID) for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
300944|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
300945|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
300946|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
300947|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
300948|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
300949|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
300950|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
301065|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
300951|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
300952|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
300953|NCT01244828|E1|Reported Event|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
300954|NCT01244815|B5|Baseline|Total|Total of all reporting groups
300955|NCT01244815|B4|Baseline|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
300956|NCT01244815|B3|Baseline|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
300957|NCT01244815|B2|Baseline|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
300958|NCT01244815|B1|Baseline|Placebo|Participants receive placebo BID for 21 days.
300959|NCT01244815|P4|Participant Flow|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
300960|NCT01244815|P3|Participant Flow|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
300961|NCT01244815|P2|Participant Flow|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
300962|NCT01244815|P1|Participant Flow|Placebo|Participants receive placebo twice daily (BID) for 21 days.
300963|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
300964|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
300965|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
300966|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
300967|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
300968|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
300969|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
300970|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
300971|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
300972|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
300973|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
300974|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
300975|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
300976|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
300977|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
300978|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
301152|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
300979|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
300980|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
300981|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
300982|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
300983|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
300984|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
300985|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
300986|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
300987|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
300988|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
300989|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
300990|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
300991|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
300992|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
300993|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
300994|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
300995|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
300996|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
300997|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
300998|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
300999|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
301000|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
301001|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
301002|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
301003|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
301004|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
301005|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
301006|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
301007|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
301008|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
301011|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
301012|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
301013|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
301014|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
301015|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
301016|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
301017|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
301018|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
301019|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
301020|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
301021|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
301022|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
301023|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
301024|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
301025|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
301026|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
301027|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
301028|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
301029|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
301030|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
301031|NCT01244815|E4|Reported Event|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
301032|NCT01244815|E3|Reported Event|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
301033|NCT01244815|E2|Reported Event|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
301034|NCT01244815|E1|Reported Event|Placebo|Participants receive placebo BID for 21 days.
301035|NCT01244724|B1|Baseline|Lexapro|Lexapro: Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
301036|NCT01244724|P1|Participant Flow|Lexapro|Lexapro: Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
301037|NCT01244724|O1|Outcome|Lexapro|Lexapro: Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
301038|NCT01244724|E1|Reported Event|Lexapro|Lexapro: Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
301066|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301039|NCT01244711|B1|Baseline|Quetiapine|"Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.~quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects."
301040|NCT01244711|P1|Participant Flow|Quetiapine|"Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.~quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects."
301041|NCT01244711|O1|Outcome|Quetiapine|"Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.~quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects."
301042|NCT01244711|E1|Reported Event|Quetiapine|"Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.~quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects."
301043|NCT01244633|B1|Baseline|Ecopipam|"Active treatment~Ecopipam: 50 or 100 mg tablets given once per day for eight weeks"
301044|NCT01244633|P1|Participant Flow|Ecopipam|"Active treatment~Ecopipam: 50 or 100 mg tablets given once per day for eight weeks"
301045|NCT01244633|O1|Outcome|Ecopipam|"Active treatment~Ecopipam: 50 or 100 mg tablets given once per day for eight weeks"
301046|NCT01244633|E1|Reported Event|Ecopipam|"Active treatment~Ecopipam: 50 or 100 mg tablets given once per day for eight weeks"
301047|NCT01244620|B1|Baseline|Entire Study Population|All randomized participants
301048|NCT01244620|P4|Participant Flow|Sitax and Sild, Then Sitax and Tad, Then Tad, Then Sitax|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg table TID for 6 days, then sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days, then tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD for 6 days. Only the first treatment in the sequence was administered due to the early termination.
301049|NCT01244620|P3|Participant Flow|Sitax and Tad, Then Sitax, Then Sitax and Sild, Then Tad|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD for 6 days, then sitaxsentan100 mg tablet QD co-administered with sildenafil 20 mg table TID for 6 days, then tadalafil 40 mg tablet QD for 6 days. Only the first treatment in the sequence was administered due to the early termination.
301050|NCT01244620|P2|Participant Flow|Tad, Then Sitax and Sild, Then Sitax, Then Sitax and Tad|Tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg table TID for 6 days, then sitaxsentan 100 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days. Only the first treatment in the sequence was administered due to the early termination.
301051|NCT01244620|P1|Participant Flow|Sitax, Then Tad, Then Sitax and Tad, Then Sitax and Sild|Sitaxsentan 100 milligram (mg) tablet once daily (QD) for 6 days, then tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg table three times daily (TID) for 6 days. Only the first treatment in the sequence was administered due to the early termination.
301052|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301053|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301054|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301055|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301056|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301057|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301058|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301059|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301060|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301061|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301062|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301063|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301064|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301153|NCT01244490|O1|Outcome|Placebo|Once daily
301067|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301068|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301069|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301070|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301071|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301072|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301073|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301074|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301075|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301076|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301077|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301078|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301079|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
301080|NCT01244620|E4|Reported Event|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg table TID for 6 days
301081|NCT01244620|E3|Reported Event|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days
301082|NCT01244620|E2|Reported Event|Tadalafil|Tadalafil 40 mg tablet QD for 6 days
301083|NCT01244620|E1|Reported Event|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days
301084|NCT01244529|B1|Baseline|All Subjects|All subjects who where enrolled wore all intervention lenses throughout the course of the study. The specific lenses used include the following: senofilcon A (control) soft contact lens with 8.8 base; senofilcon A (control) soft contact lens with 8.4 base curve; galyfilcon A (control) soft contact lens with 8.7 base curve; galyfilcon A (control) soft contact lens with 8.3 base curve; galyfilcon A Plus (test) soft contact lens with 8.7 base curve; galyfilcon A Plus (test) soft contact lens with 8.3 base curve.
301085|NCT01244529|P1|Participant Flow|All Arms, All Interventions|All subjects wore all intervention throughout the course of the study.
301086|NCT01244529|O4|Outcome|Galyfilcon AP 8.7 BC vs Senofilcon A 8.8 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
301087|NCT01244529|O3|Outcome|Galyfilcon AP 8.7 BC vs Galyfilcon A 8.7 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
301088|NCT01244529|O2|Outcome|Galyfilcon AP 8.3 BC vs Senofilcon A 8.4 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
301089|NCT01244529|O1|Outcome|Galyfilcon AP 8.3 BC vs Galyfilcon A 8.3 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
301090|NCT01244529|O6|Outcome|Senofilcon A 8.8 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
301091|NCT01244529|O5|Outcome|Galyfilcon A 8.7 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
301092|NCT01244529|O4|Outcome|Galyfilcon AP 8.7 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
301093|NCT01244529|O3|Outcome|Senofilcon A 8.4 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
301094|NCT01244529|O2|Outcome|Galyfilcon A 8.3 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
301095|NCT01244529|O1|Outcome|Galyfilcon AP 8.3 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
301096|NCT01244529|O6|Outcome|Senofilcon A 8.8 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
301097|NCT01244529|O5|Outcome|Galyfilcon A 8.7 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
301098|NCT01244529|O4|Outcome|Galyfilcon AP 8.7 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
301099|NCT01244529|O3|Outcome|Senofilcon A 8.4 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
301100|NCT01244529|O2|Outcome|Galyfilcon A 8.3 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
301101|NCT01244529|O1|Outcome|Galyfilcon AP 8.3 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
301102|NCT01244529|O3|Outcome|Senofilcon A|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
301103|NCT01244529|O2|Outcome|Galyfilcon A (Control)|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
301104|NCT01244529|O1|Outcome|Galyfilcon A Plus (Test)|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
301109|NCT01244516|B1|Baseline|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.
301110|NCT01244516|P3|Participant Flow|Comfilcon A|Subjects that were randomized to wear comfilcon A lens throughout the course of the study.
301111|NCT01244516|P2|Participant Flow|Lotrafilcon B|Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.
301112|NCT01244516|P1|Participant Flow|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.
301113|NCT01244516|O2|Outcome|Comfilcon A|Subjects that were randomized to wear comfilcon A lens throughout the course of the study.
301114|NCT01244516|O1|Outcome|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.
301115|NCT01244516|O3|Outcome|Comfilcon A|Subjects that were randomized to wear comfilcon A lens throughout the course of the study.
301116|NCT01244516|O2|Outcome|Lotrafilcon B|Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.
301117|NCT01244516|O1|Outcome|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.
301118|NCT01244516|O3|Outcome|Comfilcon A|Subjects that were randomized to wear comfilcon A lens throughout the course of the study.
301119|NCT01244516|O2|Outcome|Lotrafilcon B|Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.
301120|NCT01244516|O1|Outcome|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.
301121|NCT01244516|E3|Reported Event|Comfilcon A|Subjects that were randomized to wear comfilcon A lens throughout the course of the study.
301122|NCT01244516|E2|Reported Event|Lotrafilcon B|Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.
301123|NCT01244516|E1|Reported Event|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.
301124|NCT01244503|B1|Baseline|Sodium Octanoate Breath Test|"Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.~Sodium Octanoate Breath Test: 100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed."
301125|NCT01244503|P1|Participant Flow|Sodium Octanoate Breath Test|"Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.~Sodium Octanoate Breath Test: 100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed."
301126|NCT01244503|O1|Outcome|Sodium Octanoate Breath Test|"Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.~Sodium Octanoate Breath Test: 100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed."
301127|NCT01244503|O1|Outcome|Sodium Octanoate Breath Test|"Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.~Sodium Octanoate Breath Test: 100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed."
301128|NCT01244503|E1|Reported Event|Sodium Octanoate Breath Test|"Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.~Sodium Octanoate Breath Test: 100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed."
301129|NCT01244490|B4|Baseline|Total|Total of all reporting groups
301130|NCT01244490|B3|Baseline|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
301131|NCT01244490|B2|Baseline|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
301132|NCT01244490|B1|Baseline|Placebo|Once daily
301133|NCT01244490|P3|Participant Flow|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
301134|NCT01244490|P2|Participant Flow|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
301135|NCT01244490|P1|Participant Flow|Placebo|Once daily
301136|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
301137|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
301138|NCT01244490|O1|Outcome|Placebo|Once daily
301139|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
301140|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
301141|NCT01244490|O1|Outcome|Placebo|Once daily
301142|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
301143|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
301144|NCT01244490|O1|Outcome|Placebo|Once daily
301145|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
301146|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
301147|NCT01244490|O1|Outcome|Placebo|Once daily
301148|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
301149|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
301150|NCT01244490|O1|Outcome|Placebo|Once daily
301151|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
301154|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
301155|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
301156|NCT01244490|O1|Outcome|Placebo|Once daily
301157|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
301158|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
301159|NCT01244490|O1|Outcome|Placebo|Once daily
301160|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
301161|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
301162|NCT01244490|O1|Outcome|Placebo|Once daily
301163|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
301164|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
301165|NCT01244490|O1|Outcome|Placebo|Once daily
301166|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
301167|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
301168|NCT01244490|O1|Outcome|Placebo|Once daily
301169|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
301170|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
301171|NCT01244490|O1|Outcome|Placebo|Once daily
301172|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
301173|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
301174|NCT01244490|O1|Outcome|Placebo|Once daily
301175|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
301176|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
301177|NCT01244490|O1|Outcome|Placebo|Once daily
301178|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
301179|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
301180|NCT01244490|O1|Outcome|Placebo|Once daily
301181|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
301182|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
301183|NCT01244490|O1|Outcome|Placebo|Once daily
301184|NCT01244490|E3|Reported Event|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
301185|NCT01244490|E2|Reported Event|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
301186|NCT01244490|E1|Reported Event|Placebo|Once daily
301187|NCT01244477|B3|Baseline|Total|Total of all reporting groups
301188|NCT01244477|B2|Baseline|Arm 2|Participants randomly assigned to the Waitlist Control Group (who will participate in CPT-C after 12 weeks).
301189|NCT01244477|B1|Baseline|Arm 1|"Participants in group CPT-C~Group CPT-C: Participants will be randomly assigned to participate in CPT-C or a 12 week waitlist control group. Waitlist control subjects will participate in CPT-C after the 12 weeks."
301190|NCT01244477|P2|Participant Flow|Treatment-as-Usual|Participants who chose to participate in a 12-week treatment as usual group and offered CPT-C group treatment after 12 weeks.
301191|NCT01244477|P1|Participant Flow|CPT-C|Group Cognitive Processing Therapy-C (CPT-C): Participants who chose to participate in a 12-week CPT-C treatment group.
301192|NCT01244477|O2|Outcome|Treatment-as-Usual|Participants who chose to participate in a 12-week treatment as usual group and offered CPT-C group treatment after 12 weeks.
301193|NCT01244477|O1|Outcome|CPT-C|"Participants in group CPT-C~Group CPT-C: Participants who chose to participate in a 12-week CPT-C treatment group."
301194|NCT01244477|O2|Outcome|Treatment-as-Usual|Participants who chose to participate in a 12-week treatment as usual group and offered CPT-C group treatment after 12 weeks.
301195|NCT01244477|O1|Outcome|CPT-C|"Participants in group CPT-C~Group CPT-C: Participants who chose to participate in a 12-week CPT-C treatment group."
301196|NCT01244477|O2|Outcome|Treatment-as-Usual|Participants who chose to participate in a 12-week treatment as usual group and offered CPT-C group treatment after 12 weeks.
301197|NCT01244477|O1|Outcome|CPT-C|"Participants in group CPT-C~Group CPT-C: Participants who chose to participate in a 12-week CPT-C treatment group."
301198|NCT01244477|E2|Reported Event|Treatment-as-Usual|Participants randomly assigned to the Waitlist Control Group (who will participate in CPT-C after 12 weeks).
301199|NCT01244477|E1|Reported Event|CPT-C|"Participants in group CPT-C~Group CPT-C: Participants will be randomly assigned to participate in CPT-C or a 12 week waitlist control group. Waitlist control subjects will participate in CPT-C after the 12 weeks."
301200|NCT01244425|B3|Baseline|Total|Total of all reporting groups
301201|NCT01244425|B2|Baseline|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the oozing resection surface of the liver. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.
301202|NCT01244425|B1|Baseline|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.
301203|NCT01244425|P2|Participant Flow|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the oozing resection surface of the liver. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.
301246|NCT01244126|E2|Reported Event|Fentanyl IN|Intranasal fentanyl 2 mcg/kg IN
301247|NCT01244126|E1|Reported Event|IM Morphine|0.1 mg/kg morphine IM
301204|NCT01244425|P1|Participant Flow|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.
301205|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
301206|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.
301207|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
301208|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.
301209|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
301210|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.
301211|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
301212|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.
301213|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver. Hemostasis will be assessed at 10 minutes after application of the study treatment.
301214|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 10 minutes after application of the study treatment.
301215|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver. Hemostasis will be assessed at 8 minutes after application of the study treatment.
301216|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 8 minutes after application of the study treatment.
301217|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver. Hemostasis will be assessed at 6 minutes after application of the study treatment.
301218|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 6 minutes after application of the study treatment.
301219|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver. Hemostasis will be assessed at 4 minutes after application of the study treatment.
301220|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 4 minutes after application of the study treatment.
301221|NCT01244425|E2|Reported Event|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
301222|NCT01244425|E1|Reported Event|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.
301223|NCT01244412|B1|Baseline|Imaged Subjects|
301224|NCT01244412|P1|Participant Flow|Imaged Subjects|Subjects imaged with hand held device
301225|NCT01244412|O1|Outcome|Imaged Subjects|
301226|NCT01244412|E1|Reported Event|Imaged Subjects|
301227|NCT01244243|B1|Baseline|Active Therapy|"All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.~Hand & Wrist Assisting Robotic Device: Treatment occurs in 2 hour sessions, 4 times a week over 3 weeks."
301228|NCT01244243|P1|Participant Flow|Active Therapy|All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
301229|NCT01244243|O1|Outcome|Active Therapy|All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
301230|NCT01244243|O1|Outcome|Active Therapy|All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
301231|NCT01244243|E1|Reported Event|Active Therapy|All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
301232|NCT01244126|B4|Baseline|Total|Total of all reporting groups
301233|NCT01244126|B3|Baseline|Fentanyl IN|Intranasal fentanyl 2 mcg/kg IN
301234|NCT01244126|B2|Baseline|IV Morphine|0.1 mg/kg morphine IV
301235|NCT01244126|B1|Baseline|IM Morphine|0.1 mg/kg morphine IM
301236|NCT01244126|P3|Participant Flow|Fentanyl IN|Intranasal fentanyl 2 mcg/kg IN
301237|NCT01244126|P2|Participant Flow|IV Morphine|0.1 mg/kg morphine IV
301238|NCT01244126|P1|Participant Flow|IM Morphine|0.1 mg/kg morphine IM
301239|NCT01244126|O3|Outcome|Fentanyl IN|Intranasal fentanyl 2 mcg/kg IN
301240|NCT01244126|O2|Outcome|IV Morphine|0.1 mg/kg morphine IV
301241|NCT01244126|O1|Outcome|IM Morphine|0.1 mg/kg morphine IM
301242|NCT01244126|O3|Outcome|Fentanyl IN|Intranasal fentanyl 2 mcg/kg IN
301243|NCT01244126|O2|Outcome|IV Morphine|0.1 mg/kg morphine IV
301244|NCT01244126|O1|Outcome|IM Morphine|0.1 mg/kg morphine IM
301245|NCT01244126|E3|Reported Event|IV Morphine|0.1 mg/kg morphine IV
301249|NCT01244061|B2|Baseline|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
301250|NCT01244061|B1|Baseline|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
301251|NCT01244061|P2|Participant Flow|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
301252|NCT01244061|P1|Participant Flow|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
301253|NCT01244061|O2|Outcome|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
301254|NCT01244061|O1|Outcome|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
301255|NCT01244061|O2|Outcome|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
301256|NCT01244061|O1|Outcome|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
301257|NCT01244061|O2|Outcome|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
301258|NCT01244061|O1|Outcome|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
301259|NCT01244061|O2|Outcome|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
301260|NCT01244061|O1|Outcome|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
301261|NCT01244061|E2|Reported Event|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
301262|NCT01244061|E1|Reported Event|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
301263|NCT01243944|B3|Baseline|Total|Total of all reporting groups
301264|NCT01243944|B2|Baseline|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
301265|NCT01243944|B1|Baseline|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
301266|NCT01243944|P2|Participant Flow|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
301267|NCT01243944|P1|Participant Flow|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg once a day (QD) to 25 mg BID based on safety and efficacy
301268|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
301269|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
301270|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
301271|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
301272|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
301273|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
301274|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
301275|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
301276|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
301277|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
301278|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
301279|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
301280|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
301281|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
301282|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
301283|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
301284|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
301285|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
301286|NCT01243944|E2|Reported Event|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
301287|NCT01243944|E1|Reported Event|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
301288|NCT01243892|B3|Baseline|Total|Total of all reporting groups
301289|NCT01243892|B2|Baseline|ISS Participants|ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
301290|NCT01243892|B1|Baseline|IGHD Participants|IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
301291|NCT01243892|P2|Participant Flow|ISS Participants|Idiopathic short stature (ISS) participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
301292|NCT01243892|P1|Participant Flow|IGHD Participants|Isolated growth hormone deficient (IGHD) participants who initiated somatropin (Deoxyribonucleic acid [DNA] origin) (recombinant human growth hormone [rhGH]) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
301293|NCT01243892|O2|Outcome|ISS Participants|ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
301294|NCT01243892|O1|Outcome|IGHD Participants|IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
301295|NCT01243892|O2|Outcome|ISS Participants|ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
301296|NCT01243892|O1|Outcome|IGHD Participants|IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
301297|NCT01243892|O2|Outcome|ISS Participants|ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
301298|NCT01243892|O1|Outcome|IGHD Participants|IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
301299|NCT01243892|E2|Reported Event|ISS Participants|ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
301300|NCT01243892|E1|Reported Event|IGHD Participants|IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
301301|NCT01243775|B1|Baseline|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)
301302|NCT01243775|P1|Participant Flow|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)
301303|NCT01243775|O1|Outcome|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
301304|NCT01243775|O1|Outcome|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
301305|NCT01243775|O1|Outcome|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
301306|NCT01243775|O1|Outcome|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
301307|NCT01243775|E1|Reported Event|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
301308|NCT01243762|B8|Baseline|Total|Total of all reporting groups
301309|NCT01243762|B7|Baseline|Dalotuzumab + Ridaforolimus|Participants received dalotuzumab 10 mg/kg IV weekly + ridaforolimus 20 mg PO daily for 5 consecutive days per week in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301310|NCT01243762|B6|Baseline|Dalotuzumab 10 mg/kg + MK-2206 200 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 200 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301311|NCT01243762|B5|Baseline|Dalotuzumab 10 mg/kg + MK-2206 150 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 150 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301312|NCT01243762|B4|Baseline|Dalotuzumab 10 mg/kg + MK-2206 135 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 135 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301313|NCT01243762|B3|Baseline|Dalotuzumab 10 mg/kg + MK-2206 90 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 90 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301314|NCT01243762|B2|Baseline|Dalotuzumab 10 mg/kg + MK-0752 1800 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301315|NCT01243762|B1|Baseline|Dalotuzumab 7.5 mg/kg + MK-0752 1800 mg|Participants received dalotuzumab 7.5 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301316|NCT01243762|P7|Participant Flow|Dalotuzumab + Ridaforolimus|Participants received dalotuzumab 10 mg/kg IV weekly + ridaforolimus 20 mg PO daily for 5 consecutive days per week in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301317|NCT01243762|P6|Participant Flow|Dalotuzumab 10 mg/kg + MK-2206 200 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 200 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301318|NCT01243762|P5|Participant Flow|Dalotuzumab 10 mg/kg + MK-2206 150 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 150 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301319|NCT01243762|P4|Participant Flow|Dalotuzumab 10 mg/kg + MK-2206 135 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 135 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301320|NCT01243762|P3|Participant Flow|Dalotuzumab 10 mg/kg + MK-2206 90 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 90 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301321|NCT01243762|P2|Participant Flow|Dalotuzumab 10 mg/kg + MK-0752 1800 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301322|NCT01243762|P1|Participant Flow|Dalotuzumab 7.5 mg/kg + MK-0752 1800 mg|Participants received dalotuzumab 7.5 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301323|NCT01243762|O3|Outcome|Dalotuzumab + Ridaforolimus|Participants received dalotuzumab 10 mg/kg IV weekly + ridaforolimus 20 mg PO daily for 5 consecutive days per week in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301324|NCT01243762|O2|Outcome|Dalotuzumab 10 mg/kg + MK-2206 150 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 150 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301325|NCT01243762|O1|Outcome|Dalotuzumab 10 mg/kg + MK-0752 1800 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301326|NCT01243762|O7|Outcome|Dalotuzumab + Ridaforolimus|Participants received dalotuzumab 10 mg/kg IV weekly + ridaforolimus 20 mg PO daily for 5 consecutive days per week in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301327|NCT01243762|O6|Outcome|Dalotuzumab 10 mg/kg + MK-2206 200 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 200 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301328|NCT01243762|O5|Outcome|Dalotuzumab 10 mg/kg + MK-2206 150 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 150 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301329|NCT01243762|O4|Outcome|Dalotuzumab 10 mg/kg + MK-2206 135 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 135 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301330|NCT01243762|O3|Outcome|Dalotuzumab 10 mg/kg + MK-2206 90 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 90 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301331|NCT01243762|O2|Outcome|Dalotuzumab 10 mg/kg + MK-0752 1800 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301332|NCT01243762|O1|Outcome|Dalotuzumab 7.5 mg/kg + MK-0752 1800 mg|Participants received dalotuzumab 7.5 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301471|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301333|NCT01243762|E7|Reported Event|Dalotuzumab + Ridaforolimus|Participants received dalotuzumab 10 mg/kg IV weekly + ridaforolimus 20 mg PO daily for 5 consecutive days per week in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301334|NCT01243762|E6|Reported Event|Dalotuzumab 10 mg/kg + MK-2206 200 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 200 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301335|NCT01243762|E5|Reported Event|Dalotuzumab 10 mg/kg + MK-2206 150 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 150 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301336|NCT01243762|E4|Reported Event|Dalotuzumab 10 mg/kg + MK-2206 135 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 135 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301337|NCT01243762|E3|Reported Event|Dalotuzumab 10 mg/kg + MK-2206 90 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 90 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301338|NCT01243762|E2|Reported Event|Dalotuzumab 10 mg/kg + MK-0752 1800 mg|Participants received dalotuzumab 10 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301339|NCT01243762|E1|Reported Event|Dalotuzumab 7.5 mg/kg + MK-0752 1800 mg|Participants received dalotuzumab 7.5 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
301340|NCT01243671|B1|Baseline|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
301341|NCT01243671|P1|Participant Flow|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
301342|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
301343|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
301344|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
301345|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
301346|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
301347|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
301348|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
301349|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
301350|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
301351|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
301352|NCT01243671|E1|Reported Event|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
301353|NCT01243619|B1|Baseline|All Participants|All participants in the trial received an FDG PET scan before and after chemoradiation for esophageal cancer. In addition, as experimental staging studies, patients on this protocol received a third FDG PET scan during chemoradiation, and received three FLT PET scans before, during and after chemoradiation. All patients received standard of care chemotherapy and radiation and went on to esphagectomy.
301354|NCT01243619|P1|Participant Flow|All Participants|All participants in the trial received an FDG PET scan before and after chemoradiation for esophageal cancer. In addition, as experimental staging studies, patients on this protocol received a third FDG PET scan during chemoradiation, and received three FLT PET scans before, during and after chemoradiation. All patients received standard of care chemotherapy and radiation and went on to esphagectomy.
301381|NCT01243580|O2|Outcome|AG200-15|"AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention~AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE"
301472|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301355|NCT01243619|O1|Outcome|All Participants|"All participants in the trial received an FDG PET scan before and after chemoradiation for esophageal cancer. In addition, as experimental staging studies, patients on this protocol received a third FDG PET scan during chemoradiation, and received three FLT PET scans before, during and after chemoradiation. All patients received standard of care chemotherapy and radiation and went on to esphagectomy.~All patients accepted and complied with having three sets of PET scans performed (six total PET scans).~The software used in this protocol has allowed quantitative comparison among the PET scans."
301356|NCT01243619|E1|Reported Event|All Participants|All participants in the trial received an FDG PET scan before and after chemoradiation for esophageal cancer. In addition, as experimental staging studies, patients on this protocol received a third FDG PET scan during chemoradiation, and received three FLT PET scans before, during and after chemoradiation. All patients received standard of care chemotherapy and radiation and went on to esphagectomy.
301357|NCT01243580|B3|Baseline|Total|Total of all reporting groups
301358|NCT01243580|B2|Baseline|Ortho-Cyclen® /AG200-15|Subject applied AG200-15 in cycle 1. Subjects received Ortho-Cyclen® (Cycle 2) followed by AG200-15 (Cycle 3).
301359|NCT01243580|B1|Baseline|AG200-15/Ortho-Cyclen®|Subject applied AG200-15 in cycle 1. Subjects applied AG200-15 (Cycle 2) followed by oral contraceptive, Ortho-Cyclen® (Cycle 3)
301360|NCT01243580|P2|Participant Flow|Ortho-Cyclen®/AG200-15|AG200-15 transdermal contraceptive delivery system, delivering 25-30 mcg ethinyl estradiol and 100-120 mcg levonorgestrel per day, was applied for 3 consecutive weeks and removed on the 4th week for a patch free week. This regimen occurred for Cycle 1 and Cycle 3. Ortho-Cyclen®, containing 250 mcg norgestimate and 35 mcg ethinyl estradiol, was taken daily for 21 days followed by a drug free interval of 7 days for Cycle 2.
301361|NCT01243580|P1|Participant Flow|AG200-15/Ortho-Cyclen®|AG200-15 transdermal contraceptive delivery system, delivering 25-30 mcg ethinyl estradiol/ 100-120 mcg levonorgestrel per day, was applied weekly for 3 consecutive weeks and was removed on the 4th week for a patch free week. This regimen occurred for Cycles 1 and 2. For cycle 3, Ortho-Cyclen® containing 250 mcg norgestimate and 35 mcg ethinyl estradiol was taken daily for 21 days followed by a drug free interval of 7 days.
301362|NCT01243580|O1|Outcome|AG200-15|"AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention~AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE"
301363|NCT01243580|O1|Outcome|AG200-15|"AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention~AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE"
301364|NCT01243580|O1|Outcome|AG200-15|"AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention~AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE"
301365|NCT01243580|O2|Outcome|AG200-15|"AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention~AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE"
301366|NCT01243580|O1|Outcome|Ortho-Cyclen®|"Ortho-Cyclen® is a comparator drug intervention~Ortho-Cyclen: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen."
301367|NCT01243580|O2|Outcome|AG200-15|"AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention~AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE"
301368|NCT01243580|O1|Outcome|Ortho-Cyclen®|"Ortho-Cyclen® is a comparator drug intervention~Ortho-Cyclen: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen."
301369|NCT01243580|O2|Outcome|AG200-15|"AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention~AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE"
301370|NCT01243580|O1|Outcome|Ortho-Cyclen®|"Ortho-Cyclen® is a comparator drug intervention~Ortho-Cyclen: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen."
301371|NCT01243580|O2|Outcome|AG200-15|"AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention~AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE"
301372|NCT01243580|O1|Outcome|Ortho-Cyclen®|"Ortho-Cyclen® is a comparator drug intervention~Ortho-Cyclen: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen."
301373|NCT01243580|O2|Outcome|AG200-15|"AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention~AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE"
301374|NCT01243580|O1|Outcome|Ortho-Cyclen®|"Ortho-Cyclen® is a comparator drug intervention~Ortho-Cyclen: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen."
301375|NCT01243580|O2|Outcome|AG200-15|"AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention~AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE"
301376|NCT01243580|O1|Outcome|Ortho-Cyclen®|"Ortho-Cyclen® is a comparator drug intervention~Ortho-Cyclen: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen."
301377|NCT01243580|O2|Outcome|AG200-15|"AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention~AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE"
301378|NCT01243580|O1|Outcome|Ortho-Cyclen®|"Ortho-Cyclen® is a comparator drug intervention~Ortho-Cyclen: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen."
301379|NCT01243580|O2|Outcome|AG200-15|"AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention~AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE"
301380|NCT01243580|O1|Outcome|Ortho-Cyclen®|"Ortho-Cyclen® is a comparator drug intervention~Ortho-Cyclen: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen."
301468|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301382|NCT01243580|O1|Outcome|Ortho-Cyclen®|"Ortho-Cyclen® is a comparator drug intervention~Ortho-Cyclen: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen."
301383|NCT01243580|O2|Outcome|AG200-15|"AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention~AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of levonorgestrel (LNG) and 25 - 30 mcg EE"
301384|NCT01243580|O1|Outcome|Ortho-Cyclen®|"Ortho-Cyclen® is a comparator drug intervention~Ortho-Cyclen: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen."
301385|NCT01243580|E2|Reported Event|AG200-15|"AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention~AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE"
301386|NCT01243580|E1|Reported Event|Ortho-Cyclen®|"Ortho-Cyclen® is a comparator drug intervention~Ortho-Cyclen: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen."
301387|NCT01243567|B3|Baseline|Total|Total of all reporting groups
301388|NCT01243567|B2|Baseline|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
301389|NCT01243567|B1|Baseline|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
301390|NCT01243567|P2|Participant Flow|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
301391|NCT01243567|P1|Participant Flow|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
301392|NCT01243567|O2|Outcome|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
301393|NCT01243567|O1|Outcome|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
301394|NCT01243567|O2|Outcome|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
301395|NCT01243567|O1|Outcome|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
301396|NCT01243567|O2|Outcome|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
301397|NCT01243567|O1|Outcome|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
301398|NCT01243567|O2|Outcome|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
301399|NCT01243567|O1|Outcome|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
301400|NCT01243567|O2|Outcome|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
301401|NCT01243567|O1|Outcome|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
301402|NCT01243567|E2|Reported Event|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
301403|NCT01243567|E1|Reported Event|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
301404|NCT01243450|B4|Baseline|Total|Total of all reporting groups
301405|NCT01243450|B3|Baseline|Placebo|Placebo group
301406|NCT01243450|B2|Baseline|Brand|Brand group
301407|NCT01243450|B1|Baseline|Active Generic|Active generic group
301408|NCT01243450|P3|Participant Flow|Brand|Tretinoin: Topical skin
301409|NCT01243450|P2|Participant Flow|Placebo|"placebo cream~Tretinoin: Topical skin~placebo"
301410|NCT01243450|P1|Participant Flow|Active Generic|"active cream~Tretinoin: Topical skin"
301411|NCT01243450|O3|Outcome|Brand|Tretinoin: Topical skin
301412|NCT01243450|O2|Outcome|Placebo|"placebo cream~Tretinoin: Topical skin~placebo"
301413|NCT01243450|O1|Outcome|Active Generic|"active cream~Tretinoin: Topical skin"
301414|NCT01243450|E3|Reported Event|Brand|Tretinoin: Topical skin
301415|NCT01243450|E2|Reported Event|Placebo|"placebo cream~Tretinoin: Topical skin~placebo"
301416|NCT01243450|E1|Reported Event|Active Generic|"active cream~Tretinoin: Topical skin"
301417|NCT01243411|B1|Baseline|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
301418|NCT01243411|P1|Participant Flow|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
301419|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
301469|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301420|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
301421|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
301422|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
301423|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
301424|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
301425|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
301426|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
301427|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
301428|NCT01243411|E1|Reported Event|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
301429|NCT01243320|B1|Baseline|All Study Participants|10 ppm Silver, then 32 ppm Silver
301430|NCT01243320|P1|Participant Flow|All Study Participants|Study had two dosing phases. All study participants were assigned the 10ppm Oral Silver and proceed to the 32 pm Oral Silver.
301431|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301432|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301433|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301434|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301435|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301436|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301437|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301438|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301439|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301440|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301441|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301442|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301443|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301444|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301445|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301446|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301447|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301448|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301449|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301450|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301451|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301452|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301453|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301454|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301455|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301456|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301457|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301458|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301459|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301460|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301461|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301462|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301463|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301464|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301465|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301466|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301467|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301473|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301474|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301475|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301476|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301477|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301478|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301479|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301480|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301481|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301482|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301483|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301484|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301485|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301486|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301487|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301488|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301489|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301490|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301491|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301492|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301493|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301494|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301495|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301496|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301497|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301498|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301499|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301500|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301501|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
301502|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
301503|NCT01243320|E2|Reported Event|32ppm Oral Solution|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
301504|NCT01243320|E1|Reported Event|10ppm Oral Solution|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
301505|NCT01243294|B1|Baseline|Entire Study Population|Includes groups randomized to receive SS (new ostomy bag)first and SenSura first
301506|NCT01243294|P2|Participant Flow|SS First, Then SenSura|"SS = new ostomy bag. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
301507|NCT01243294|P1|Participant Flow|SenSura First, Then SS|"SS = new ostomy bag. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
301508|NCT01243294|O2|Outcome|SenSura|"CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
301509|NCT01243294|O1|Outcome|New Adhesive SS|"SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
301510|NCT01243294|O2|Outcome|SenSura|"CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
301541|NCT01243177|P1|Participant Flow|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
301644|NCT01242371|B2|Baseline|Identical-appearing Placebo|Identical appearing placebo 1 tablet by mouth daily for 14 weeks
301511|NCT01243294|O1|Outcome|New Adhesive SS|"SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
301512|NCT01243294|O2|Outcome|SenSura|"CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
301513|NCT01243294|O1|Outcome|New Adhesive SS|"SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
301514|NCT01243294|O2|Outcome|SenSura|"CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
301515|NCT01243294|O1|Outcome|New Adhesive SS|"SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
301516|NCT01243294|O2|Outcome|SenSura|"CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
301517|NCT01243294|O1|Outcome|New Adhesive SS|"SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
301518|NCT01243294|O2|Outcome|SenSura|"CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
301519|NCT01243294|O1|Outcome|New Adhesive SS|"SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
301520|NCT01243294|E2|Reported Event|SS (New Ostomy Bag)|Base plates applied 1 till 6 times a day SS = new ostomy bag
301521|NCT01243294|E1|Reported Event|SenSura|Base plates applied 1 till 6 times a day
301522|NCT01243242|B3|Baseline|Total|Total of all reporting groups
301523|NCT01243242|B2|Baseline|Placebo|Eligible subjects who received 1400 mg of Placebo
301524|NCT01243242|B1|Baseline|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
301525|NCT01243242|P2|Participant Flow|Placebo|Eligible subjects who received 1400 mg of Placebo
301526|NCT01243242|P1|Participant Flow|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
301527|NCT01243242|O2|Outcome|Placebo|Eligible subjects who received 1400 mg of Placebo
301528|NCT01243242|O1|Outcome|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
301529|NCT01243242|O2|Outcome|Placebo|Eligible subjects who received 1400 mg of Placebo
301530|NCT01243242|O1|Outcome|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
301531|NCT01243242|O2|Outcome|Placebo|Eligible subjects who received 1400 mg of Placebo
301532|NCT01243242|O1|Outcome|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
301533|NCT01243242|O2|Outcome|Placebo|Eligible subjects who received 1400 mg of Placebo
301534|NCT01243242|O1|Outcome|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
301535|NCT01243242|E2|Reported Event|Placebo|Eligible subjects who received 1400 mg of Placebo
301536|NCT01243242|E1|Reported Event|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
301537|NCT01243177|B3|Baseline|Total Title|
301538|NCT01243177|B2|Baseline|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
301539|NCT01243177|B1|Baseline|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
301540|NCT01243177|P2|Participant Flow|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
301629|NCT01242514|O2|Outcome|Fostamatinib 150 mg qd|Oral treatment
301542|NCT01243177|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
301543|NCT01243177|O1|Outcome|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
301544|NCT01243177|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
301545|NCT01243177|O1|Outcome|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
301546|NCT01243177|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
301547|NCT01243177|O1|Outcome|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
301548|NCT01243177|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
301549|NCT01243177|O1|Outcome|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
301550|NCT01243177|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
301551|NCT01243177|O1|Outcome|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
301552|NCT01243177|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
301553|NCT01243177|O1|Outcome|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
301554|NCT01243177|E2|Reported Event|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
301555|NCT01243177|E1|Reported Event|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
301556|NCT01243112|B1|Baseline|Study Group|0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
301557|NCT01243112|P1|Participant Flow|Study Group|0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
301558|NCT01243112|O1|Outcome|Study Group|0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
301559|NCT01243112|O1|Outcome|Study Group|0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
301560|NCT01243112|E1|Reported Event|Study Group|0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
301561|NCT01242813|B1|Baseline|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
301562|NCT01242813|P1|Participant Flow|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 milligram/ kilogram (mg/kg) for participants equal to or less than (≤) 40 kg or 150 mg for participants more than (>) 40 kg) through subcutaneous (s.c.) route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TNF-receptor associated periodic syndrome (TRAPS) flare.
301563|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
301564|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
301630|NCT01242514|O1|Outcome|Fostamatinib 100 mg Bid|Oral treatment
301631|NCT01242514|O3|Outcome|Fostamatinib 100 mg qd|Oral treatment
301565|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
301566|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
301567|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
301568|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
301569|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
301570|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
301571|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
301572|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
301573|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
301574|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
301575|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
301576|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
301577|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
301578|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
301579|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
301580|NCT01242813|E1|Reported Event|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
301581|NCT01242748|B3|Baseline|Total|Total of all reporting groups
301582|NCT01242748|B2|Baseline|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
301583|NCT01242748|B1|Baseline|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
301632|NCT01242514|O2|Outcome|Fostamatinib 150 mg qd|Oral treatment
301633|NCT01242514|O1|Outcome|Fostamatinib 100 mg Bid|Oral treatment
301634|NCT01242514|O3|Outcome|Fostamatinib 100 mg qd|Oral treatment
301584|NCT01242748|P2|Participant Flow|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
301585|NCT01242748|P1|Participant Flow|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
301586|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
301587|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
301588|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
301589|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
301590|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
301591|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
301592|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
301593|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
301594|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
301595|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
301635|NCT01242514|O2|Outcome|Fostamatinib 150 mg qd|Oral treatment
301636|NCT01242514|O1|Outcome|Fostamatinib 100 mg Bid|Oral treatment
301637|NCT01242514|O3|Outcome|Fostamatinib 100 mg qd|Oral treatment
301596|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
301597|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
301598|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
301599|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
301600|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
301601|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
301602|NCT01242748|E2|Reported Event|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
301603|NCT01242748|E1|Reported Event|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
301604|NCT01242527|B5|Baseline|Total|Total of all reporting groups
301605|NCT01242527|B4|Baseline|Epanova 4 g|omefas : 4 capsules (1g)daily for 12 weeks
301606|NCT01242527|B3|Baseline|Epanova 3 g|omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks
301607|NCT01242527|B2|Baseline|Epanova 2 g|omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks
301608|NCT01242527|B1|Baseline|Olive Oil (Placebo)|placebo : 4 capsules (1g) daily for 12 weeks
301609|NCT01242527|P4|Participant Flow|Epanova 4 g|omefas : 4 capsules (1g)daily for 12 weeks
301610|NCT01242527|P3|Participant Flow|Epanova 3 g|omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks
301611|NCT01242527|P2|Participant Flow|Epanova 2 g|omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks
301612|NCT01242527|P1|Participant Flow|Olive Oil (Placebo Control)|placebo : 4 capsules (1g) daily for 12 weeks
301613|NCT01242527|O4|Outcome|Epanova 4 g|omefas : 4 capsules (1g)daily for 12 weeks
301614|NCT01242527|O3|Outcome|Epanova 3 g|omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks
301615|NCT01242527|O2|Outcome|Epanova 2 g|omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks
301616|NCT01242527|O1|Outcome|Olive Oil (Placebo)|placebo : 4 capsules (1g) daily for 12 weeks
301617|NCT01242527|E4|Reported Event|Epanova 4 g|omefas : 4 capsules (1g)daily for 12 weeks
301618|NCT01242527|E3|Reported Event|Epanova 3 g|omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks
301619|NCT01242527|E2|Reported Event|Epanova 2 g|omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks
301620|NCT01242527|E1|Reported Event|Olive Oil (Placebo)|placebo : 4 capsules (1g) daily for 12 weeks
301621|NCT01242514|B4|Baseline|Total|Total of all reporting groups
301622|NCT01242514|B3|Baseline|Fostamatinib 100 mg qd|Oral treatment
301623|NCT01242514|B2|Baseline|Fostamatinib 150 mg qd|Oral treatment
301624|NCT01242514|B1|Baseline|Fostamatinib 100 mg Bid|Oral treatment
301625|NCT01242514|P3|Participant Flow|Fostamatinib 100 mg qd|Oral treatment
301626|NCT01242514|P2|Participant Flow|Fostamatinib 150 mg qd|Oral treatment
301627|NCT01242514|P1|Participant Flow|Fostamatinib 100 mg Bid|Oral treatment
301628|NCT01242514|O3|Outcome|Fostamatinib 100 mg qd|Oral treatment
301645|NCT01242371|B1|Baseline|Probiotic Supplement|Probiotic supplement 1 tablet by mouth daily for 14 weeks
301646|NCT01242371|P2|Participant Flow|Identical-appearing Placebo|Identical appearing placebo 1 tablet by mouth daily for 14 weeks
301647|NCT01242371|P1|Participant Flow|Probiotic Supplement|Probiotic supplement 1 tablet by mouth daily for 14 weeks
301648|NCT01242371|O2|Outcome|Identical-appearing Placebo|Identical appearing placebo 1 tablet by mouth daily for 14 weeks
301649|NCT01242371|O1|Outcome|Probiotic Supplement|Probiotic supplement 1 tablet by mouth daily for 14 weeks
301650|NCT01242371|E2|Reported Event|Identical-appearing Placebo|Identical appearing placebo 1 tablet by mouth daily for 14 weeks
301651|NCT01242371|E1|Reported Event|Probiotic Supplement|Probiotic supplement 1 tablet by mouth daily for 14 weeks
301652|NCT01242176|B1|Baseline|Study Overall|"An open-label, randomised, two-way crossover study. The two treatments administered were~A single dose of empagliflozin (empa) 25mg, final formulation~A single dose of empa 25mg, trial formulation 2~Between drug administrations there was a washout period of at least 7 days."
301653|NCT01242176|P2|Participant Flow|Empa TF2 / Empa FF|Single dose of 25mg empagliflozin (empa) trial formulation 2 (TF2) followed by a single dose of 25mg of empa final formulation (FF), with a washout period of at least 7 days between treatments.
301654|NCT01242176|P1|Participant Flow|Empa FF / Empa TF2|Single dose of 25mg of empagliflozin (empa) final formulation (FF) followed by a single dose of 25mg empa trial formulation 2 (TF2), with a washout period of at least 7 days between treatments.
301655|NCT01242176|O2|Outcome|Empa TF2|Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
301656|NCT01242176|O1|Outcome|Empa FF|Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours.
301657|NCT01242176|O2|Outcome|Empa TF2|Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
301658|NCT01242176|O1|Outcome|Empa FF|Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours.
301659|NCT01242176|O2|Outcome|Empa TF2|Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
301660|NCT01242176|O1|Outcome|Empa FF|Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours.
301661|NCT01242176|E2|Reported Event|Empa TF2|Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
301662|NCT01242176|E1|Reported Event|Empa FF|Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours.
301663|NCT01242111|B1|Baseline|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
301664|NCT01242111|P1|Participant Flow|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
301665|NCT01242111|O1|Outcome|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
301666|NCT01242111|O1|Outcome|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
301667|NCT01242111|O1|Outcome|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
301668|NCT01242111|O1|Outcome|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
301669|NCT01242111|O1|Outcome|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
301670|NCT01242111|O1|Outcome|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
301671|NCT01242111|E1|Reported Event|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
301672|NCT01242085|B4|Baseline|Total|Total of all reporting groups
301673|NCT01242085|B3|Baseline|Both Interventions|one participant had bilateral knee replacement with one control knee and one trumatch knee
301674|NCT01242085|B2|Baseline|Trumatch Group|patients randomized to study instrumentation
301675|NCT01242085|B1|Baseline|Control|"control group will have standard instrumentation of their knee replacement: standard instrumentation for knee replacement~study group will have customized knee instruments : CT based customized knee instruments"
301676|NCT01242085|P3|Participant Flow|Both Interventions|one participant had both interventions - one for each knee
301677|NCT01242085|P2|Participant Flow|Control Group|control group will have standard instrumentation of their knee replacement
301678|NCT01242085|P1|Participant Flow|Trumatch Group|trumatch group will have customized knee instruments : CT based customized knee instruments
301679|NCT01242085|O2|Outcome|Trumatch Group|patients randomized to study instrumentation
301680|NCT01242085|O1|Outcome|Control|"control group will have standard instrumentation of their knee replacement: standard instrumentation for knee replacement~study group will have customized knee instruments : CT based customized knee instruments"
301681|NCT01242085|O2|Outcome|Trumatch Group|patients randomized to study instrumentation
301682|NCT01242085|O1|Outcome|Control|"control group will have standard instrumentation of their knee replacement: standard instrumentation for knee replacement~study group will have customized knee instruments : CT based customized knee instruments"
301683|NCT01242085|E2|Reported Event|Trumatch Group|patients randomized to study instrumentation
301684|NCT01242085|E1|Reported Event|Control|"control group will have standard instrumentation of their knee replacement: standard instrumentation for knee replacement~study group will have customized knee instruments : CT based customized knee instruments"
301685|NCT01242020|B3|Baseline|Total|Total of all reporting groups
301738|NCT01241591|B5|Baseline|Total|Total of all reporting groups
301686|NCT01242020|B2|Baseline|Obese Healthy Subjects|"Obese grade I-II defined as (BMI>30 and ≤35)~Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
301687|NCT01242020|B1|Baseline|Lean Healthy Subjects|"Lean defined as (BMI ≥18 and ≤25)~Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
301688|NCT01242020|P2|Participant Flow|Obese Healthy Subjects|"Obese grade I-II defined as (BMI>30 and ≤35)~Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
301689|NCT01242020|P1|Participant Flow|Lean Healthy Subjects|"Lean defined as (BMI ≥18 and ≤25)~Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
301690|NCT01242020|O2|Outcome|Obese Healthy Subjects|"Obese grade I-II defined as (BMI>30 and ≤35)~Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
301691|NCT01242020|O1|Outcome|Lean Healthy Subjects|"Lean defined as (BMI ≥18 and ≤25)~Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
301692|NCT01242020|O2|Outcome|Obese Healthy Subjects|"Obese grade I-II defined as (BMI>30 and ≤35)~Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
301693|NCT01242020|O1|Outcome|Lean Healthy Subjects|"Lean defined as (BMI ≥18 and ≤25)~Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
301694|NCT01242020|E2|Reported Event|Obese Healthy Subjects|"Obese grade I-II defined as (BMI>30 and ≤35)~Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
301695|NCT01242020|E1|Reported Event|Lean Healthy Subjects|"Lean defined as (BMI ≥18 and ≤25)~Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
301696|NCT01241916|B3|Baseline|Total|Total of all reporting groups
301697|NCT01241916|B2|Baseline|Dynamic Splint|Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
301698|NCT01241916|B1|Baseline|Static-progressive Splint|Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.
301699|NCT01241916|P2|Participant Flow|Dynamic Splint|Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
301700|NCT01241916|P1|Participant Flow|Static-progressive Splint|Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.
301701|NCT01241916|O2|Outcome|Dynamic Splint|Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
301702|NCT01241916|O1|Outcome|Static-progressive Splint|Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.
301703|NCT01241916|O2|Outcome|Dynamic Splint|Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
301704|NCT01241916|O1|Outcome|Static-progressive Splint|Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.
301705|NCT01241916|E2|Reported Event|Dynamic Splint|Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
301706|NCT01241916|E1|Reported Event|Static-progressive Splint|Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.
301707|NCT01241903|B3|Baseline|Total|Total of all reporting groups
301708|NCT01241903|B2|Baseline|Rosuvastatin|Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
301709|NCT01241903|B1|Baseline|Placebo|Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.
301710|NCT01241903|P2|Participant Flow|Rosuvastatin|Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
301711|NCT01241903|P1|Participant Flow|Placebo|Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.
301712|NCT01241903|O2|Outcome|Rosuvastatin|Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
301713|NCT01241903|O1|Outcome|Placebo|Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.
301714|NCT01241903|E2|Reported Event|Rosuvastatin|Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
301715|NCT01241903|E1|Reported Event|Placebo|Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.
301716|NCT01241760|B3|Baseline|Total|Total of all reporting groups
301717|NCT01241760|B2|Baseline|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
301936|NCT01241565|P1|Participant Flow|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|Single arm study, all patients will receive the study device.
301718|NCT01241760|B1|Baseline|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
301719|NCT01241760|P2|Participant Flow|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
301720|NCT01241760|P1|Participant Flow|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
301721|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
301722|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
301723|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
301724|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
301725|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
301726|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
301727|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
301728|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
301729|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
301730|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
301731|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
301732|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
301733|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
301734|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
301735|NCT01241760|E3|Reported Event|Total|All
301736|NCT01241760|E2|Reported Event|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
301737|NCT01241760|E1|Reported Event|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
301739|NCT01241591|B4|Baseline|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301740|NCT01241591|B3|Baseline|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301741|NCT01241591|B2|Baseline|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301742|NCT01241591|B1|Baseline|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301743|NCT01241591|P4|Participant Flow|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301744|NCT01241591|P3|Participant Flow|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301745|NCT01241591|P2|Participant Flow|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301746|NCT01241591|P1|Participant Flow|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301747|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301748|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301749|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301750|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301751|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301752|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301753|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301754|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301755|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301756|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301757|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301758|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301759|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301760|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301761|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301762|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301763|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301764|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301765|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301766|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301767|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301768|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301769|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301770|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301771|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301772|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301773|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301774|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301775|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301776|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301777|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301778|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301779|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301780|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301781|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301782|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301783|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301784|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301785|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301786|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301787|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301788|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301789|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301790|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301791|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301792|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301793|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301794|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
306470|NCT01228591|O2|Outcome|Acuvue Advance|Acuvue Advance contact lenses worn.
301795|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301796|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301797|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301798|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301799|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301800|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301801|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301802|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301803|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301804|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301805|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301806|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301807|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301808|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301809|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301810|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301811|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301812|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301813|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301814|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301815|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301816|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301817|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301818|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301819|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301820|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301821|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301822|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
306471|NCT01228591|O1|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses worn.
301823|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301824|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301825|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301826|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301827|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301828|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301829|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301830|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301831|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301832|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301833|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301834|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301835|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301836|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301837|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301838|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301839|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301840|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301841|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301842|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301843|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301844|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301845|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301846|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301847|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301848|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301849|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301850|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
306472|NCT01228591|O2|Outcome|Acuvue Advance|Acuvue Advance contact lenses worn
301851|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301852|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301853|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301854|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301855|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301856|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301857|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301858|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301859|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301860|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301861|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301862|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301863|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301864|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301865|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301866|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301867|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301868|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301869|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301870|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301871|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301872|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301873|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301874|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301875|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301876|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301877|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301878|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
306473|NCT01228591|O1|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses worn
301879|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301880|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301881|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301882|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301883|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301884|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301885|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301886|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301887|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301888|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301889|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301890|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301891|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301892|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301893|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301894|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301895|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301896|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301897|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301898|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301899|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301900|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301901|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301902|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301903|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301904|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301905|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301906|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
306474|NCT01228591|O2|Outcome|Acuvue Advance|Acuvue Advance contact lenses - Binocular Measurements
301907|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301908|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301909|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301910|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301911|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301912|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301913|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301914|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301915|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301916|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301917|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301918|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301919|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301920|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301921|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301922|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301923|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301924|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301925|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301926|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301927|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301928|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301929|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301930|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301931|NCT01241591|E4|Reported Event|Placebo|Participants received matching placebo tablets, orally, BID at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301932|NCT01241591|E3|Reported Event|Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301933|NCT01241591|E2|Reported Event|CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets, orally, BID at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301934|NCT01241591|E1|Reported Event|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
301935|NCT01241565|B1|Baseline|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|Single arm study, all patients will receive the study device.
301937|NCT01241565|O1|Outcome|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|"Single arm study, all patients will receive the study device.~ENDO GIA™ Stapler with TRI-STAPLE™ Technology: All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology"
301938|NCT01241565|O1|Outcome|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|"Single arm study, all patients will receive the study device.~ENDO GIA™ Stapler with TRI-STAPLE™ Technology: All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology"
301939|NCT01241565|O1|Outcome|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|"Single arm study, all patients will receive the study device.~ENDO GIA™ Stapler with TRI-STAPLE™ Technology: All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology"
301940|NCT01241565|O1|Outcome|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|"Single arm study, all patients will receive the study device.~ENDO GIA™ Stapler with TRI-STAPLE™ Technology: All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology"
301941|NCT01241565|O1|Outcome|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|"Single arm study, all patients will receive the study device.~ENDO GIA™ Stapler with TRI-STAPLE™ Technology: All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology"
301942|NCT01241565|O1|Outcome|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|Single arm study, all patients will receive the study device.
301943|NCT01241565|E1|Reported Event|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|Single arm study, all patients will receive the study device.
301944|NCT01241552|B5|Baseline|Total|Total of all reporting groups
301945|NCT01241552|B4|Baseline|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
301946|NCT01241552|B3|Baseline|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
301947|NCT01241552|B2|Baseline|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
301948|NCT01241552|B1|Baseline|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
301949|NCT01241552|P4|Participant Flow|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
301950|NCT01241552|P3|Participant Flow|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
301951|NCT01241552|P2|Participant Flow|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
301952|NCT01241552|P1|Participant Flow|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care (SOC) for CDI
301953|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
301954|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
301955|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
301956|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
301957|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
301958|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
301959|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
301960|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
301961|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
301962|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
301963|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
301964|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
301965|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
301966|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
301967|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
301968|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
301969|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
301970|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
301971|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
301972|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
301973|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
301974|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
301975|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
301976|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
301977|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
301978|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
301979|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
301980|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
301981|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
301982|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
301983|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
301984|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
301985|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
301986|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
301987|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
301988|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
301989|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
301990|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
301991|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
301992|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
301993|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
301994|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
301995|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
301996|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
301997|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
301998|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
301999|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
302000|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
302001|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
302002|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
302003|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
302004|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
302005|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
302006|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
302007|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
302008|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
302009|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
302010|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
302011|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
302012|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
302013|NCT01241552|E4|Reported Event|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + SOC for CDI
302014|NCT01241552|E3|Reported Event|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK 3415A + SOC for CDI
302015|NCT01241552|E2|Reported Event|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
302016|NCT01241552|E1|Reported Event|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + SOC for CDI
302017|NCT01241539|B1|Baseline|Dabigatran|Dabigatran treated patients
302018|NCT01241539|P1|Participant Flow|Dabigatran|Period 1 target blood flow rate during dialysis was 200mL/min. Period 2 target blood flow rate during dialysis was 400mL/min.
302019|NCT01241539|O1|Outcome|Dabigatran|Dabigatran treated patients
302020|NCT01241539|O1|Outcome|Dabigatran|Dabigatran treated patients
302021|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
302022|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
302023|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
302024|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
302025|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
302026|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
302027|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
302028|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
302029|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
302030|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
302031|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
302032|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
302033|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
302034|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
302035|NCT01241539|E1|Reported Event|Dabigatran|Dabigatran treated patients
302036|NCT01241513|B3|Baseline|Total|Total of all reporting groups
302037|NCT01241513|B2|Baseline|Placebo|Placebo
302038|NCT01241513|B1|Baseline|N-acetylcysteine (NAC)|NAC
302039|NCT01241513|P2|Participant Flow|Placebo|Placebo
302040|NCT01241513|P1|Participant Flow|N-acetylcysteine|Active drug group
302041|NCT01241513|O2|Outcome|NAC Group|N-acetyl-L-Cysteine (800 mg T.I.D. in diet soda) for 4 days
302042|NCT01241513|O1|Outcome|Placebo Group|Placebo (Diet soda only)
302043|NCT01241513|E1|Reported Event|NAC Group and Placebo Group|
302044|NCT01241448|B5|Baseline|Total|Total of all reporting groups
302045|NCT01241448|B4|Baseline|20 mg LY2409021|20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302046|NCT01241448|B3|Baseline|10 mg LY2409021|10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302047|NCT01241448|B2|Baseline|2.5 mg LY2409021|2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302048|NCT01241448|B1|Baseline|Placebo|Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302049|NCT01241448|P4|Participant Flow|20 mg LY2409021|20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302050|NCT01241448|P3|Participant Flow|10 mg LY2409021|10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302051|NCT01241448|P2|Participant Flow|2.5 mg LY2409021|2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302052|NCT01241448|P1|Participant Flow|Placebo|Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302053|NCT01241448|O4|Outcome|20 mg LY2409021|20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302054|NCT01241448|O3|Outcome|10 mg LY2409021|10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302055|NCT01241448|O2|Outcome|2.5 mg LY2409021|2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302056|NCT01241448|O1|Outcome|Placebo|Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302057|NCT01241448|O4|Outcome|20 mg LY2409021|20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302058|NCT01241448|O3|Outcome|10 mg LY2409021|10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302059|NCT01241448|O2|Outcome|2.5 mg LY2409021|2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302060|NCT01241448|O1|Outcome|Placebo|Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302061|NCT01241448|O1|Outcome|LY2409021|2.5 mg, 10 mg or 20 mg LY2409021 taken orally once daily for 24 weeks
302062|NCT01241448|O1|Outcome|LY2409021|2.5 mg, 10 mg or 20 mg LY2409021 taken orally once daily for 24 weeks
302063|NCT01241448|O4|Outcome|20 mg LY2409021|20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302064|NCT01241448|O3|Outcome|10 mg LY2409021|10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302065|NCT01241448|O2|Outcome|2.5 mg LY2409021|2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302066|NCT01241448|O1|Outcome|Placebo|Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302067|NCT01241448|O4|Outcome|20 mg LY2409021|20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302068|NCT01241448|O3|Outcome|10 mg LY2409021|10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302069|NCT01241448|O2|Outcome|2.5 mg LY2409021|2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302070|NCT01241448|O1|Outcome|Placebo|Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302071|NCT01241448|O4|Outcome|20 mg LY2409021|20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302072|NCT01241448|O3|Outcome|10 mg LY2409021|10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302073|NCT01241448|O2|Outcome|2.5 mg LY2409021|2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302074|NCT01241448|O1|Outcome|Placebo|Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302075|NCT01241448|O4|Outcome|20 mg LY2409021|20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302076|NCT01241448|O3|Outcome|10 mg LY2409021|10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302077|NCT01241448|O2|Outcome|2.5 mg LY2409021|2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302078|NCT01241448|O1|Outcome|Placebo|Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302790|NCT01239511|E2|Reported Event|Treatment Group A|150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
302079|NCT01241448|O4|Outcome|20 mg LY2409021|20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302080|NCT01241448|O3|Outcome|10 mg LY2409021|10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302081|NCT01241448|O2|Outcome|2.5 mg LY2409021|2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302082|NCT01241448|O1|Outcome|Placebo|Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302083|NCT01241448|O4|Outcome|20 mg LY2409021|20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302084|NCT01241448|O3|Outcome|10 mg LY2409021|10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302085|NCT01241448|O2|Outcome|2.5 mg LY2409021|2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302086|NCT01241448|O1|Outcome|Placebo|Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302087|NCT01241448|O4|Outcome|20 mg LY2409021|20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302088|NCT01241448|O3|Outcome|10 mg LY2409021|10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302089|NCT01241448|O2|Outcome|2.5 mg LY2409021|2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302090|NCT01241448|O1|Outcome|Placebo|Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302091|NCT01241448|O4|Outcome|20 mg LY2409021|20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302092|NCT01241448|O3|Outcome|10 mg LY2409021|10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302093|NCT01241448|O2|Outcome|2.5 mg LY2409021|2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302094|NCT01241448|O1|Outcome|Placebo|Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302095|NCT01241448|O4|Outcome|20 mg LY2409021|20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302096|NCT01241448|O3|Outcome|10 mg LY2409021|10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302097|NCT01241448|O2|Outcome|2.5 mg LY2409021|2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302098|NCT01241448|O1|Outcome|Placebo|Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302099|NCT01241448|O4|Outcome|20 mg LY2409021|20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302100|NCT01241448|O3|Outcome|10 mg LY2409021|10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302101|NCT01241448|O2|Outcome|2.5 mg LY2409021|2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302102|NCT01241448|O1|Outcome|Placebo|Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302103|NCT01241448|O4|Outcome|20 mg LY2409021|20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302104|NCT01241448|O3|Outcome|10 mg LY2409021|10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302105|NCT01241448|O2|Outcome|2.5 mg LY2409021|2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302106|NCT01241448|O1|Outcome|Placebo|Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302107|NCT01241448|O4|Outcome|20 mg LY2409021|20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302108|NCT01241448|O3|Outcome|10 mg LY2409021|10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302109|NCT01241448|O2|Outcome|2.5 mg LY2409021|2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302110|NCT01241448|O1|Outcome|Placebo|Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302395|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
302111|NCT01241448|E4|Reported Event|20 mg LY2409021|20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302112|NCT01241448|E3|Reported Event|10 mg LY2409021|10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302113|NCT01241448|E2|Reported Event|2.5 mg LY2409021|2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302114|NCT01241448|E1|Reported Event|Placebo|Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
302115|NCT01241292|B3|Baseline|Total|Total of all reporting groups
302116|NCT01241292|B2|Baseline|Elotuzumab 20 mg/kg|Elotuzumab was intravenously (IV) injected at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered as a single dose of 40 mg PO. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
302117|NCT01241292|B1|Baseline|Elotuzumab 10 mg/kg|Elotuzumab was intravenously (IV) injected at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered as a single dose of 40 mg PO. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
302118|NCT01241292|P2|Participant Flow|Elotuzumab 20 mg/kg|Elotuzumab 20 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
302119|NCT01241292|P1|Participant Flow|Elotuzumab 10 mg/kg|Elotuzumab 10 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
302120|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
302121|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
302122|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|Elotuzumab 20 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
302396|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
302123|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|Elotuzumab 10 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
302124|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
302125|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
302126|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
302127|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
302128|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
302129|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
302130|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
302152|NCT01241240|B2|Baseline|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
302153|NCT01241240|B1|Baseline|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
302219|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302131|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
302132|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
302133|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
302134|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
302135|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
302136|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|Elotuzumab was intravenously (IV) injected at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered as a single dose of 40 mg PO. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) AND 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
302137|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|Elotuzumab was intravenously (IV) injected at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered as a single dose of 40 mg PO. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) AND 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
302138|NCT01241292|E2|Reported Event|BMS 20mg/kg + Ld|
302139|NCT01241292|E1|Reported Event|BMS 10mg/kg + Ld|
302140|NCT01241279|B3|Baseline|Total|Total of all reporting groups
302141|NCT01241279|B2|Baseline|SoftPort LI61AO|A silicone multi-piece foldable aspheric intraocular lens
302142|NCT01241279|B1|Baseline|Crystalens AO|A silicone multi-piece accommodating intraocular lens
302143|NCT01241279|P2|Participant Flow|SoftPort LI61AO|A silicone multi-piece foldable aspheric intraocular lens
302144|NCT01241279|P1|Participant Flow|Crystalens AO|A silicone multi-piece accommodating intraocular lens
302145|NCT01241279|O2|Outcome|SoftPort LI61AO|A silicone multi-piece foldable aspheric intraocular lens
302146|NCT01241279|O1|Outcome|Crystalens AO|A silicone multi-piece accommodating intraocular lens
302147|NCT01241279|O2|Outcome|SoftPort LI61AO|A silicone multi-piece foldable aspheric intraocular lens
302148|NCT01241279|O1|Outcome|Crystalens AO|A silicone multi-piece accommodating intraocular lens
302149|NCT01241279|E2|Reported Event|SoftPort LI61AO|A silicone multi-piece foldable aspheric intraocular lens
302150|NCT01241279|E1|Reported Event|Crystalens AO|A silicone multi-piece accommodating intraocular lens
302151|NCT01241240|B3|Baseline|Total|Total of all reporting groups
302218|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302154|NCT01241240|P2|Participant Flow|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
302155|NCT01241240|P1|Participant Flow|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
302156|NCT01241240|O2|Outcome|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
302157|NCT01241240|O1|Outcome|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
302158|NCT01241240|O2|Outcome|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
302159|NCT01241240|O1|Outcome|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
302160|NCT01241240|O2|Outcome|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
302161|NCT01241240|O1|Outcome|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
302162|NCT01241240|E2|Reported Event|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
302163|NCT01241240|E1|Reported Event|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
302164|NCT01240915|B9|Baseline|Total|Total of all reporting groups
302165|NCT01240915|B8|Baseline|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302166|NCT01240915|B7|Baseline|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302167|NCT01240915|B6|Baseline|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302168|NCT01240915|B5|Baseline|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302169|NCT01240915|B4|Baseline|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302170|NCT01240915|B3|Baseline|Cohort 1: MultiStem 300 or MultiStem 300 (x3), Placebo|Participants received either a single dose of MultiStem 300 Million Cells infusion on Day 1 or 3 doses on Day 1, Week 1, and Week 2; followed by a single dose of placebo infusion at Week 8.
302171|NCT01240915|B2|Baseline|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302172|NCT01240915|B1|Baseline|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
302173|NCT01240915|P9|Participant Flow|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302174|NCT01240915|P8|Participant Flow|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302175|NCT01240915|P7|Participant Flow|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302176|NCT01240915|P6|Participant Flow|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302177|NCT01240915|P5|Participant Flow|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302178|NCT01240915|P4|Participant Flow|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
302179|NCT01240915|P3|Participant Flow|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302180|NCT01240915|P2|Participant Flow|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302181|NCT01240915|P1|Participant Flow|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
302182|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302183|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302184|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302791|NCT01239511|E1|Reported Event|Placebo Group|placebo capsule 2# t.i.d./day
302185|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302186|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302187|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
302188|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302189|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302190|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
302191|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302192|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302193|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302194|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302195|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302196|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
302197|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302198|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302199|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
302200|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302201|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302202|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302203|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302204|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302205|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
302206|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302207|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302208|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
302209|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302210|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302211|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302212|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302213|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302214|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
302215|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302216|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302217|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
302220|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302221|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302222|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302223|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
302224|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302225|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302226|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
302227|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302228|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302229|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302230|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302231|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302232|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
302233|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302234|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302235|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
302236|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302237|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302238|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302239|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302240|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302241|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
302242|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302243|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302244|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
302245|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302246|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302247|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302248|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302249|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302250|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
302251|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302252|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
306704|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
302253|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
302254|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302255|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302256|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302257|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302258|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302259|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
302260|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302261|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302262|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
302263|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302264|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302265|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302266|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302267|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302268|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
302269|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302270|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302271|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
302272|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302273|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302274|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302275|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302276|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302277|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
302278|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302279|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302280|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
302281|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302282|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302283|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302284|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302285|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
307468|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
302286|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
302287|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302288|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302289|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
302290|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302291|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302292|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302293|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302294|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302295|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
302296|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302297|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302298|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
302299|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302300|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302301|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302302|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302303|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302304|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
302305|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302306|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302307|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
302308|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302309|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302310|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302311|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302312|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302313|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
302314|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302315|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302316|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
302317|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302318|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
307469|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
302319|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302320|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302321|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302322|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
302323|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302324|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302325|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
302326|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302327|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302328|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302329|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302330|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302331|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
302332|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302333|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302334|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
302335|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302336|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302337|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302338|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302339|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302340|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
302341|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302342|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302343|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
302344|NCT01240915|O2|Outcome|Pooled Placebo|All participants who received placebo infusion on Day 1 in Cohort 3.
302345|NCT01240915|O1|Outcome|Pooled MultiStem|All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.
302346|NCT01240915|O2|Outcome|Pooled Placebo|All participants who received placebo infusion on Day 1 in Cohort 3.
302347|NCT01240915|O1|Outcome|Pooled MultiStem|All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.
302348|NCT01240915|O2|Outcome|Pooled Placebo|All participants who received placebo infusion on Day 1 in Cohort 3.
302349|NCT01240915|O1|Outcome|Pooled MultiStem|All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.
302350|NCT01240915|E9|Reported Event|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302351|NCT01240915|E8|Reported Event|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302352|NCT01240915|E7|Reported Event|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302353|NCT01240915|E6|Reported Event|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302792|NCT01239394|B1|Baseline|Ofatumumab|"single-arm, open-label, interventional~ofatumumab: Weekly infusion for 8 weeks"
302354|NCT01240915|E5|Reported Event|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302355|NCT01240915|E4|Reported Event|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
302356|NCT01240915|E3|Reported Event|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
302357|NCT01240915|E2|Reported Event|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
302358|NCT01240915|E1|Reported Event|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
302359|NCT01240902|B5|Baseline|Total|Total of all reporting groups
302360|NCT01240902|B4|Baseline|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
302361|NCT01240902|B3|Baseline|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
302362|NCT01240902|B2|Baseline|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
302363|NCT01240902|B1|Baseline|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
302364|NCT01240902|P4|Participant Flow|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
302365|NCT01240902|P3|Participant Flow|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
302366|NCT01240902|P2|Participant Flow|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
302367|NCT01240902|P1|Participant Flow|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
302368|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
302369|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
302370|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
302371|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
302372|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
302373|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
302374|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
302375|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
302376|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
302377|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
302378|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
302379|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
302380|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
302381|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
302382|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
302383|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
302384|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
302385|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
302386|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
302387|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
302388|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
302389|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
302390|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
302391|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
302392|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
302393|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
302394|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
308151|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40mg qd (once daily) subcutaneous injection
302397|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
302398|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
302399|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
302400|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
302401|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
302402|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
302403|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
302404|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
302405|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
302406|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
302407|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
302408|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
302409|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
302410|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
302411|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
302412|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
302413|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
302414|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
302415|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
302416|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
302417|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
302418|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
302419|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
302420|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
302421|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
302422|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
302423|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
302424|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
302425|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
302426|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
302427|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
302428|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
302429|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
302430|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
302431|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
302432|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
302433|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
302434|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
302435|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
302436|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
302437|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
302438|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
302793|NCT01239394|P1|Participant Flow|Ofatumumab|"single-arm, open-label, interventional~ofatumumab: Weekly infusion for 8 weeks"
302439|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
302440|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
302441|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
302442|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
302443|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
302444|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
302445|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
302446|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
302447|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
302448|NCT01240902|E4|Reported Event|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
302449|NCT01240902|E3|Reported Event|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
302450|NCT01240902|E2|Reported Event|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
302451|NCT01240902|E1|Reported Event|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
302452|NCT01240863|B3|Baseline|Total|Total of all reporting groups
302453|NCT01240863|B2|Baseline|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302454|NCT01240863|B1|Baseline|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302455|NCT01240863|P3|Participant Flow|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302456|NCT01240863|P2|Participant Flow|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets twice a day that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302457|NCT01240863|P1|Participant Flow|Hydrocodone ER (Open-Label Titration Period)|All enrolled participants entered the open label titration period and received hydrocodone extended release (ER) tablets beginning with 15 mg every 12 hours for 3 to 7 days. Dosages were titrated upward until pain was effectively controlled. If an effective dosage between 15 mg - 90 mg twice a day was not identified within 6 week, the participant was withdrawn.
302458|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302459|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302460|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302461|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302462|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302463|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302464|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302482|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302465|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302466|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302467|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302468|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302469|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302470|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302471|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302472|NCT01240863|O4|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302473|NCT01240863|O3|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302474|NCT01240863|O2|Outcome|Open-Label Titration: Opioid Experienced|"During the open label titration period, all participants received hydrocodone extended release tablets on an open-label basis. Opioid experienced participants switched from their current opioid medications to the calculated dose of hydrocodone extended release tablets based on an equianalgesic dose-conversion scheme.~A decision regarding dose adjustment was made based on whether the criterion of successful dose (ie, dose that produced stable pain relief) was met. In general, dose escalation stepped to 30 mg or 45 mg or 60 mg, or 90 mg every 12 hours until stable pain relief was obtained. The escalated dose was dependent upon the initial calculated equivalent dose."
302475|NCT01240863|O1|Outcome|Open-Label Titration: Opioid Naive|During the open label titration period, all participants received hydrocodone extended release tablets on an open-label basis. Opioid naïve participants (ie, those taking less than 10 mg/day of oxycodone or equivalent, during the 14 days before screening) started at a 15 mg dose of hydrocodone extended release, administered every 12 hours. A decision regarding dose adjustment was made based on whether the criterion of successful dose (ie, dose that produced stable pain relief) was met. In general, dose escalation stepped from 15 mg to 30 mg, 45 mg, 60 mg, and 90 mg every 12 hours until stable pain relief was obtained.
302476|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered ER hydrocodone tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302477|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302478|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302479|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302480|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302481|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302794|NCT01239394|O1|Outcome|Ofatumumab|"single-arm, open-label, interventional~ofatumumab: Weekly infusion for 8 weeks"
302483|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302484|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302485|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302486|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302487|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302488|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302489|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302490|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302491|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302492|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302493|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302494|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302495|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302496|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302497|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302498|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302499|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302500|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302501|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302502|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302503|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302504|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302505|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302506|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302507|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302508|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302509|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302510|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302511|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302512|NCT01240863|E3|Reported Event|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
302513|NCT01240863|E2|Reported Event|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets twice a day that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
302514|NCT01240863|E1|Reported Event|Hydrocodone ER (Open-Label Titration Period)|All enrolled participants entered the open label titration period and received hydrocodone extended release (ER) tablets beginning with 15 mg every 12 hours for 3 to 7 days. Dosages were titrated upward until pain was effectively controlled. If an effective dosage between 15 mg - 90 mg twice a day was not identified within 6 week, the participant was withdrawn.
302515|NCT01240811|B4|Baseline|Total|Total of all reporting groups
302516|NCT01240811|B3|Baseline|Copper T380A IUD|Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
302517|NCT01240811|B2|Baseline|Levonorgestrel IUS|Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
302518|NCT01240811|B1|Baseline|Control-No IUD|Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
302519|NCT01240811|P3|Participant Flow|Copper T380A IUD|Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
302520|NCT01240811|P2|Participant Flow|Levonorgestrel IUS|Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
302521|NCT01240811|P1|Participant Flow|Control-No IUD|Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
302522|NCT01240811|O3|Outcome|Copper T380A IUD|"Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.~IUD placement: Volunteer subjects who are not at risk of pregnancy because they are either surgically sterilized or heterosexually abstinent will be enrolled into the control group (no intervention). All other volunteers will be seeking an IUD for contraception and will be randomized to LNG-IUD (Mirena) or Copper IUD (ParaGard).~Copper T380A IUD"
302523|NCT01240811|O2|Outcome|Levonorgestrel IUS|"Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.~IUD placement: Volunteer subjects who are not at risk of pregnancy because they are either surgically sterilized or heterosexually abstinent will be enrolled into the control group (no intervention). All other volunteers will be seeking an IUD for contraception and will be randomized to LNG-IUD (Mirena) or Copper IUD (ParaGard).~Levonorgestrel IUD"
302524|NCT01240811|O1|Outcome|Control-No IUD|Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
302567|NCT01240746|B2|Baseline|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
302525|NCT01240811|O3|Outcome|Copper T380A IUD|"Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.~IUD placement: Volunteer subjects who are not at risk of pregnancy because they are either surgically sterilized or heterosexually abstinent will be enrolled into the control group (no intervention). All other volunteers will be seeking an IUD for contraception and will be randomized to LNG-IUD (Mirena) or Copper IUD (ParaGard).~Copper T380A IUD"
302526|NCT01240811|O2|Outcome|Levonorgestrel IUS|"Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.~IUD placement: Volunteer subjects who are not at risk of pregnancy because they are either surgically sterilized or heterosexually abstinent will be enrolled into the control group (no intervention). All other volunteers will be seeking an IUD for contraception and will be randomized to LNG-IUD (Mirena) or Copper IUD (ParaGard).~Levonorgestrel IUD"
302527|NCT01240811|O1|Outcome|Control-No IUD|Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
302528|NCT01240811|O3|Outcome|Copper T380A IUD|Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
302529|NCT01240811|O2|Outcome|Levonorgestrel IUS|Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
302530|NCT01240811|O1|Outcome|Control-No IUD|Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
302531|NCT01240811|E3|Reported Event|Copper T380A IUD|Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
302532|NCT01240811|E2|Reported Event|Levonorgestrel IUS|Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
302533|NCT01240811|E1|Reported Event|Control-No IUD|Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
302534|NCT01240785|B3|Baseline|Total|Total of all reporting groups
302535|NCT01240785|B2|Baseline|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
302536|NCT01240785|B1|Baseline|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
302537|NCT01240785|P2|Participant Flow|Insulin|
302538|NCT01240785|P1|Participant Flow|Metformin Arm|
302539|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
302540|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
302541|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
302542|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
302543|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
302544|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
302545|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
302546|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
302547|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
302548|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
302549|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
302550|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
302551|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
302552|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
302553|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
302554|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
302555|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
302556|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
302557|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
302558|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
302559|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
302560|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
302561|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
302562|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
302563|NCT01240785|E2|Reported Event|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
302564|NCT01240785|E1|Reported Event|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
302565|NCT01240746|B4|Baseline|Total|Total of all reporting groups
302566|NCT01240746|B3|Baseline|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
302795|NCT01239394|O1|Outcome|Ofatumumab|"single-arm, open-label, interventional~ofatumumab: Weekly infusion for 8 weeks"
302568|NCT01240746|B1|Baseline|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
302569|NCT01240746|P3|Participant Flow|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
302570|NCT01240746|P2|Participant Flow|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
302571|NCT01240746|P1|Participant Flow|Study Group 1 (2010-2011 Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen.
302572|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
302573|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
302574|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
302575|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
302576|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
302577|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
302578|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
302579|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
302580|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
302581|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
302582|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
302583|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
302584|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
302585|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
302586|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
302587|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
302588|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
302589|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
302590|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
302591|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
302592|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
302593|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
302594|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
302595|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
302596|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
302597|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
302598|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
302599|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
302600|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
302601|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
302602|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
302603|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
302604|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
302605|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
302606|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
302607|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
302608|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
302609|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
302610|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
302611|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
302612|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
302613|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
302614|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
302615|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
302616|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
302617|NCT01240746|E3|Reported Event|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
302618|NCT01240746|E2|Reported Event|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
302619|NCT01240746|E1|Reported Event|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
302620|NCT01240590|B6|Baseline|Total|Total of all reporting groups
302621|NCT01240590|B5|Baseline|Ph II Level 4: Cisplatin|100mg/m(2) Cisplatin
302622|NCT01240590|B4|Baseline|Ph II Level 3: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
302623|NCT01240590|B3|Baseline|Ph I Level 2: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
302624|NCT01240590|B2|Baseline|Ph I Level 1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
302625|NCT01240590|B1|Baseline|Ph I Level -1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin
302626|NCT01240590|P5|Participant Flow|Level 4: Cisplatin|100mg/m(2) Cisplatin Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
302627|NCT01240590|P4|Participant Flow|Level 3: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
302628|NCT01240590|P3|Participant Flow|Level 2: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
302629|NCT01240590|P2|Participant Flow|Level 1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
302630|NCT01240590|P1|Participant Flow|Level -1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
302631|NCT01240590|O5|Outcome|Ph II Level 4: Cisplatin|"100mg/m(2) Cisplatin~Cisplatin: Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)"
302632|NCT01240590|O4|Outcome|Ph II Level 3: Cisplatin + Crolibulin|"100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin~Crolibulin: Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2)~Cisplatin: Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)"
302633|NCT01240590|O3|Outcome|Ph I Level 2: Cisplatin + Crolibulin|"100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin~Crolibulin: Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2)~Cisplatin: Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)"
302634|NCT01240590|O2|Outcome|Ph I Level 1: Cisplatin + Crolibulin|"75mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin~Crolibulin: Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2)~Cisplatin: Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)"
302635|NCT01240590|O1|Outcome|Ph I Level -1: Cisplatin + Crolibulin|"75mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin~Crolibulin: Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2)~Cisplatin: Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)"
302636|NCT01240590|O5|Outcome|Ph II Level: 4 Cisplatin|100 mg/m(2) Cisplatin
302637|NCT01240590|O4|Outcome|Ph II Level: 3 Cisplatin & Crolibulin|100 mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
302638|NCT01240590|O3|Outcome|Ph I Level: 2 Cisplatin & Crolibulin|100 mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
302639|NCT01240590|O2|Outcome|Ph I Level: 1 Cisplatin & Crolibulin|75 mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
302640|NCT01240590|O1|Outcome|Ph I Level: -1 Cisplatin & Crolibulin|75 mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin
302641|NCT01240590|O5|Outcome|Ph II Level 4: Cisplatin|100mg/m(2) Cisplatin
302642|NCT01240590|O4|Outcome|Ph II Level 3: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
302643|NCT01240590|O3|Outcome|Ph I Level 2: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
302644|NCT01240590|O2|Outcome|Ph I Level 1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
302645|NCT01240590|O1|Outcome|Ph I Level -1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin
302646|NCT01240590|O2|Outcome|Ph II Level 4: Cisplatin|100mg/m(2) Cisplatin
302647|NCT01240590|O1|Outcome|Ph II Level 3: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
302648|NCT01240590|O1|Outcome|All Participants|All participants who received at least one dose of 8-20 mg/m(2)crolibulin intravenously.
302649|NCT01240590|O1|Outcome|All Participants|All participants who received at least one dose of 75-100 mg/m(2) cisplatin intravenously.
302650|NCT01240590|E5|Reported Event|Ph II Level: 4 Cisplatin|100 mg/m(2) Cisplatin
302651|NCT01240590|E4|Reported Event|Ph II Level: 3 Cisplatin & Crolibulin|100 mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
302652|NCT01240590|E3|Reported Event|Ph I Level: 2 Cisplatin & Crolibulin|100 mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
302653|NCT01240590|E2|Reported Event|Ph I Level: 1 Cisplatin & Crolibulin|75 mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
302654|NCT01240590|E1|Reported Event|Ph I Level: -1 Cisplatin & Crolibulin|75 mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin
302655|NCT01240551|B3|Baseline|Total|Total of all reporting groups
302656|NCT01240551|B2|Baseline|No-Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
302657|NCT01240551|B1|Baseline|Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
302658|NCT01240551|P2|Participant Flow|No-Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
302659|NCT01240551|P1|Participant Flow|Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
302660|NCT01240551|O2|Outcome|No-Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
302661|NCT01240551|O1|Outcome|Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
302662|NCT01240551|O2|Outcome|No-Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
302663|NCT01240551|O1|Outcome|Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
302664|NCT01240551|E2|Reported Event|No-Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
302704|NCT01240200|E2|Reported Event|Pen (Period 1) / Vial & Syringe (Period 2)|Crossover phase: patients randomized to the sequence: Insulin glargine SoloSTAR® pen in Period 1 and Insulin glargine vial and syringe in Period 2.
302796|NCT01239394|O1|Outcome|Ofatumumab|"single-arm, open-label, interventional~ofatumumab: Weekly infusion for 8 weeks"
302665|NCT01240551|E1|Reported Event|Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
302666|NCT01240382|B3|Baseline|Total|Total of all reporting groups
302667|NCT01240382|B2|Baseline|0.1% HA|0.1% sodium hyaluronate ophthalmic solution
302668|NCT01240382|B1|Baseline|3% DE-089|3% DE-089 ophthalmic solution
302669|NCT01240382|P2|Participant Flow|0.1% HA|0.1% sodium hyaluronate ophthalmic solution
302670|NCT01240382|P1|Participant Flow|3% DE-089|3% DE-089 ophthalmic solution
302671|NCT01240382|O2|Outcome|0.1% HA|0.1% sodium hyaluronate ophthalmic solution
302672|NCT01240382|O1|Outcome|3% DE-089|3% DE-089 ophthalmic solution
302673|NCT01240382|O2|Outcome|0.1% HA|0.1% sodium hyaluronate ophthalmic solution
302674|NCT01240382|O1|Outcome|3% DE-089|3% DE-089 ophthalmic solution
302675|NCT01240382|E2|Reported Event|0.1% HA|0.1% sodium hyaluronate ophthalmic solution
302676|NCT01240382|E1|Reported Event|3% DE-089|3% DE-089 ophthalmic solution
302677|NCT01240356|B3|Baseline|Total|Total of all reporting groups
302678|NCT01240356|B2|Baseline|Phase II|Phase II-20 patients with ischemic stroke treated with IV-tPA
302679|NCT01240356|B1|Baseline|Phase I|Non-stroke volunteers.
302680|NCT01240356|P2|Participant Flow|Phase II|Acute Ischemic Stroke patients received standard-doce intravenous tissue-type plasminogen activator (tPA) within 0-3 hours window.
302681|NCT01240356|P1|Participant Flow|Phase I|Non-stroke volunteers.
302682|NCT01240356|O1|Outcome|Phase I: Healthy Volunteers|Phase I - A group of 15 Non-stroke healthy volunteers.
302683|NCT01240356|O1|Outcome|Phase II - Ischemic Stroke Patients|Phase II - A group of 20 patients with ischemic stroke treated with IV-tPA
302684|NCT01240356|O1|Outcome|Phase II - Ischemic Stroke Patients|Phase II - A group of 20 patients with ischemic stroke treated with IV-tPA
302685|NCT01240356|O1|Outcome|Phase II - Iscehmic Stroke Patients|Phase II - 20 patients with ischemic stroke treated with IV-tPA
302686|NCT01240356|O1|Outcome|Phase 1 (Healthy Volunteers)|Phase I - A group of non-stroke healthy volunteers.
302687|NCT01240356|O1|Outcome|Phase II - Ischemic Stroke Patients|Phase II - A group of 20 patients with ischemic stroke treated with IV-tPA
302688|NCT01240356|O1|Outcome|Phase I|Non stroke patients
302689|NCT01240356|E2|Reported Event|Phase II - Ischemic Stroke Patients|Phase II - 20 patient with ischemic stroke treated with IV-tPA
302690|NCT01240356|E1|Reported Event|Phase I: Healthy Volunteers|Phase I - 15 non-stroke healthy volunteers.
302691|NCT01240330|B1|Baseline|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
302692|NCT01240330|P1|Participant Flow|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
302693|NCT01240330|O1|Outcome|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
302694|NCT01240330|O1|Outcome|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
302695|NCT01240330|O1|Outcome|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
302696|NCT01240330|E1|Reported Event|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
302697|NCT01240200|B3|Baseline|Total|Total of all reporting groups
302698|NCT01240200|B2|Baseline|Pen (Period 1) / Vial & Syringe (Period 2)|Crossover phase: patients randomized to the sequence: Glargine SoloSTAR® pen in Period 1 and Glargine vial and syringe in Period 2.
302699|NCT01240200|B1|Baseline|Vial & Syringe (Period 1) / Pen (Period 2)|Crossover phase: patients randomized to the sequence: Glargine vial and syringe in Period 1 and Glargine SoloSTAR pen in Period 2.
302700|NCT01240200|P2|Participant Flow|Pen (Period 1) / Vial & Syringe (Period 2)|Crossover phase: patients randomized to the sequence: Insulin glargine SoloSTAR® pen in Period 1 and Insulin glargine vial and syringe in Period 2.
302701|NCT01240200|P1|Participant Flow|Vial & Syringe (Period 1) / Pen (Period 2)|Crossover phase: patients randomized to the sequence: Insulin glargine vial and syringe in Period 1 and Insulin glargine SoloSTAR pen in Period 2.
302702|NCT01240200|O2|Outcome|Pen (Period 1) / Vial & Syringe (Period 2)|Crossover phase: patients randomized to the sequence: Insulin glargine SoloSTAR® pen in Period 1 and Insulin glargine vial and syringe in Period 2.
302703|NCT01240200|O1|Outcome|Vial & Syringe (Period 1) / Pen (Period 2)|Crossover phase: patients randomized to the sequence: Insulin glargine vial and syringe in Period 1 and Insulin glargine SoloSTAR pen in Period 2.
302705|NCT01240200|E1|Reported Event|Vial & Syringe (Period 1) / Pen (Period 2)|Crossover phase: patients randomized to the sequence: Insulin glargine vial and syringe in Period 1 and Insulin glargine SoloSTAR pen in Period 2.
302706|NCT01240135|B3|Baseline|Total|Total of all reporting groups
302707|NCT01240135|B2|Baseline|Renu Fresh / FID 114675A|Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.
302708|NCT01240135|B1|Baseline|FID 114576A / Renu Fresh|FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.
302709|NCT01240135|P2|Participant Flow|Renu Fresh / FID 114675A|Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.
302710|NCT01240135|P1|Participant Flow|FID 114576A / Renu Fresh|FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.
302711|NCT01240135|O2|Outcome|Renu Fresh|Renu fresh used for contact lens care per protocol-specified instructions for 14 days.
302712|NCT01240135|O1|Outcome|FID 114576A|FID 114675A used for contact lens care per protocol-specified instructions for 14 days.
302713|NCT01240135|O2|Outcome|Renu Fresh|Renu fresh used for contact lens care per protocol-specified instructions for 14 days.
302714|NCT01240135|O1|Outcome|FID 114576A|FID 114675A used for contact lens care per protocol-specified instructions for 14 days.
302715|NCT01240135|E2|Reported Event|Renu Fresh|Renu fresh used for contact lens care per protocol-specified instructions for 14 days.
302716|NCT01240135|E1|Reported Event|FID 114576A|FID 114675A used for contact lens care per protocol-specified instructions for 14 days.
302717|NCT01240122|B1|Baseline|Biotrue/Investigational MPS|Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period.
302718|NCT01240122|P1|Participant Flow|Biotrue/Investigational MPS|Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period.
302719|NCT01240122|O2|Outcome|Investigational MPS|Paired/parallel eye evaluation; each subject used the Investigational MPS in the alternate eye, and was tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
302720|NCT01240122|O1|Outcome|Biotrue|Paired/parallel eye evaluation; each subject was treated with Biotrue MPS in one eye, and was tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
302721|NCT01240122|O2|Outcome|Investigational MPS|Paired/parallel eye evaluation; each subject used Investigational MPS in the alternate eye and was tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
302722|NCT01240122|O1|Outcome|Biotrue MPS|Paired/parallel eye evaluation; each subject was treated with Biotrue multi-purpose solution in one eye, and was tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
302723|NCT01240122|O2|Outcome|Investigational MPS|Paired/parallel eye evaluation; each subject used both used the Investigational MPS and were tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
302724|NCT01240122|O1|Outcome|Biotrue|Paired/parallel eye evaluation; each subject was treated with Biotrue, and were tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
302725|NCT01240122|E1|Reported Event|Biotrue/Investigational MPS|Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period.
302726|NCT01239992|B1|Baseline|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
302727|NCT01239992|P1|Participant Flow|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
302728|NCT01239992|O1|Outcome|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
302729|NCT01239992|O1|Outcome|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
302730|NCT01239992|O1|Outcome|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
302731|NCT01239992|O1|Outcome|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
302732|NCT01239992|E1|Reported Event|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
302733|NCT01239797|B3|Baseline|Total|Total of all reporting groups
302734|NCT01239797|B2|Baseline|Lenalidomide + Dexamethasone|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug"
302735|NCT01239797|B1|Baseline|Lenalidomide + Dexamethasone + Elotuzumab|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (Oral):~On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (IV):~On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug~Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug"
302736|NCT01239797|P2|Participant Flow|Lenalidomide + Dexamethasone|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug"
302781|NCT01239511|P3|Participant Flow|Treatment Group B|300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
302782|NCT01239511|P2|Participant Flow|Treatment Group A|150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
302737|NCT01239797|P1|Participant Flow|Lenalidomide + Dexamethasone + Elotuzumab|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (Oral):~On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (IV):~On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug~Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug"
302738|NCT01239797|O2|Outcome|Lenalidomide + Dexamethasone|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug"
302739|NCT01239797|O1|Outcome|Lenalidomide + Dexamethasone + Elotuzumab|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (Oral):~On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (IV):~On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug~Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug"
302740|NCT01239797|O2|Outcome|Lenalidomide + Dexamethasone|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug"
302741|NCT01239797|O1|Outcome|Lenalidomide + Dexamethasone + Elotuzumab|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (Oral):~On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (IV):~On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug~Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug"
302742|NCT01239797|E2|Reported Event|Lenalidomide + Dexamethasone|Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
302743|NCT01239797|E1|Reported Event|Lenalidomide + Dexamethasone + Elotuzumab|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (Oral):~On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (IV):~On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug"
302744|NCT01239745|B1|Baseline|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
302745|NCT01239745|P1|Participant Flow|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
302746|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
302747|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
302748|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
302749|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
302750|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
302783|NCT01239511|P1|Participant Flow|Placebo Group|placebo capsule 2# t.i.d./day
302784|NCT01239511|O4|Outcome|Treatment Group C|450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
302751|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
302752|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
302753|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
302754|NCT01239745|E1|Reported Event|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
302755|NCT01239732|B1|Baseline|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
302756|NCT01239732|P1|Participant Flow|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 milligrams/kilogram (mg/kg) intravenously (IV) on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 milligram per square meter (mg/m^2) IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (area under the plasma concentration-time curve [AUC] 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
302757|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
302758|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
302759|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
302760|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
302785|NCT01239511|O3|Outcome|Treatment Group B|300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
302786|NCT01239511|O2|Outcome|Treatment Group A|150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
302787|NCT01239511|O1|Outcome|Placebo Group|placebo capsule 2# t.i.d./day
302788|NCT01239511|E4|Reported Event|Treatment Group C|450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
302789|NCT01239511|E3|Reported Event|Treatment Group B|300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
302761|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
302762|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
302763|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
302764|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
302765|NCT01239732|E1|Reported Event|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
302766|NCT01239680|B3|Baseline|Total|Total of all reporting groups
302767|NCT01239680|B2|Baseline|Glutamine: Intravenous 25 Grams Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours
302768|NCT01239680|B1|Baseline|Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional Ringer's Lactate: Ringer's Lactate: Intravenous 1 liter once over 6 hours
302769|NCT01239680|P2|Participant Flow|Glutamine: Intravenous 25 Grams Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours
302770|NCT01239680|P1|Participant Flow|Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional Ringer's Lactate: Ringer's Lactate Intravenous 1 liter once over 6 hours
302771|NCT01239680|O2|Outcome|Glutamine: Intravenous 25 Grams Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours.
302772|NCT01239680|O1|Outcome|Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional Ringer's Lactate: Ringer's Lactate: Intravenous 1 liter once over 6 hours.
302773|NCT01239680|E2|Reported Event|Glutamine: Intravenous 25 Grams Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours.
302774|NCT01239680|E1|Reported Event|Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional Ringer's Lactate: Ringer's Lactate: Intravenous 1 liter once over 6 hours.
302775|NCT01239511|B5|Baseline|Total|Total of all reporting groups
302776|NCT01239511|B4|Baseline|Treatment Group C|450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
302777|NCT01239511|B3|Baseline|Treatment Group B|300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
302778|NCT01239511|B2|Baseline|Treatment Group A|150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
302779|NCT01239511|B1|Baseline|Placebo Group|placebo capsule 2# t.i.d./day
302780|NCT01239511|P4|Participant Flow|Treatment Group C|450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
308152|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
302797|NCT01239394|O1|Outcome|Ofatumumab|"single-arm, open-label, interventional~ofatumumab: Weekly infusion for 8 weeks"
302798|NCT01239394|E1|Reported Event|Ofatumumab|"single-arm, open-label, interventional~ofatumumab: Weekly infusion for 8 weeks"
302799|NCT01239381|B1|Baseline|SBRT-Proton|"SBRT by proton radiation~Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks"
302800|NCT01239381|P1|Participant Flow|SBRT-Proton|"Stereotactic Body Radiation Therapy (SBRT) by proton radiation~Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks"
302801|NCT01239381|O1|Outcome|SBRT-Proton|"SBRT by proton radiation~Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks"
302802|NCT01239381|O1|Outcome|SBRT-Proton|"SBRT by proton radiation~Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks"
302803|NCT01239381|O1|Outcome|SBRT-Proton|"Stereotactic Body Radiation Therapy (SBRT) by proton radiation~Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks"
302804|NCT01239381|O1|Outcome|SBRT-Proton|"SBRT by proton radiation~Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks"
302805|NCT01239381|O1|Outcome|SBRT-Proton|"SBRT by proton radiation~Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks"
302806|NCT01239381|O1|Outcome|SBRT-Proton|"SBRT by proton radiation~Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks"
302807|NCT01239381|O1|Outcome|SBRT-Proton|"SBRT by proton radiation~Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks"
302808|NCT01239381|E1|Reported Event|SBRT-Proton|"SBRT by proton radiation~Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks"
302809|NCT01239355|B1|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
302810|NCT01239355|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
302811|NCT01239355|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
302812|NCT01239355|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
302813|NCT01239355|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
302814|NCT01239355|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
302815|NCT01239342|B3|Baseline|Total|Total of all reporting groups
302816|NCT01239342|B2|Baseline|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
302817|NCT01239342|B1|Baseline|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
302818|NCT01239342|P2|Participant Flow|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
302819|NCT01239342|P1|Participant Flow|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
302820|NCT01239342|O2|Outcome|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
302821|NCT01239342|O1|Outcome|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
302822|NCT01239342|O2|Outcome|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
302823|NCT01239342|O1|Outcome|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
302824|NCT01239342|O2|Outcome|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
302825|NCT01239342|O1|Outcome|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
302826|NCT01239342|O2|Outcome|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
302827|NCT01239342|O1|Outcome|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
302828|NCT01239342|O2|Outcome|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
302829|NCT01239342|O1|Outcome|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
302830|NCT01239342|O2|Outcome|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
302831|NCT01239342|O1|Outcome|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
302832|NCT01239342|E2|Reported Event|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
302833|NCT01239342|E1|Reported Event|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
302834|NCT01239316|B1|Baseline|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
302835|NCT01239316|P1|Participant Flow|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
308153|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
302836|NCT01239316|O1|Outcome|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
302837|NCT01239316|O1|Outcome|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
302838|NCT01239316|O1|Outcome|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
302839|NCT01239316|O1|Outcome|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
302840|NCT01239316|O1|Outcome|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
302841|NCT01239316|E1|Reported Event|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
302842|NCT01239212|B1|Baseline|Single Arm, 50 mg/kg of Levetiracetam|Single arm, 50 mg/kg of levetiracetam
302843|NCT01239212|P1|Participant Flow|Single Arm, 50 mg/kg of Levetiracetam|Single arm, 50 mg/kg of levetiracetam
302844|NCT01239212|O1|Outcome|Single Arm, 50 mg/kg of Levetiracetam|Single arm, 50 mg/kg of levetiracetam
302845|NCT01239212|E1|Reported Event|Single Arm, 50 mg/kg of Levetiracetam|Single arm, 50 mg/kg of levetiracetam
302846|NCT01239121|B4|Baseline|Total|Total of all reporting groups
302847|NCT01239121|B3|Baseline|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
302848|NCT01239121|B2|Baseline|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
302849|NCT01239121|B1|Baseline|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
302850|NCT01239121|P3|Participant Flow|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
302851|NCT01239121|P2|Participant Flow|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
302852|NCT01239121|P1|Participant Flow|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
302853|NCT01239121|O3|Outcome|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
302854|NCT01239121|O2|Outcome|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
302855|NCT01239121|O1|Outcome|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
302856|NCT01239121|O3|Outcome|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
302857|NCT01239121|O2|Outcome|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
302858|NCT01239121|O1|Outcome|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
302859|NCT01239121|O3|Outcome|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
302879|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
302860|NCT01239121|O2|Outcome|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
302861|NCT01239121|O1|Outcome|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
302862|NCT01239121|E3|Reported Event|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
302863|NCT01239121|E2|Reported Event|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
302864|NCT01239121|E1|Reported Event|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
302865|NCT01239056|B1|Baseline|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
302866|NCT01239056|P1|Participant Flow|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
302867|NCT01239056|O1|Outcome|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
302868|NCT01239056|O1|Outcome|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
302869|NCT01239056|O1|Outcome|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
302870|NCT01239056|E1|Reported Event|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
302871|NCT01239043|B3|Baseline|Total|Total of all reporting groups
302872|NCT01239043|B2|Baseline|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
302873|NCT01239043|B1|Baseline|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
302874|NCT01239043|P2|Participant Flow|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
302875|NCT01239043|P1|Participant Flow|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
302876|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
302877|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
302878|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
308154|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
302880|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
302881|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
302882|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
302883|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
302884|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
302885|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
302886|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
302887|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
302888|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
302889|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
302890|NCT01239043|E2|Reported Event|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
302891|NCT01239043|E1|Reported Event|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
302892|NCT01238991|B11|Baseline|Total|Total of all reporting groups
302893|NCT01238991|B10|Baseline|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302894|NCT01238991|B9|Baseline|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302895|NCT01238991|B8|Baseline|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302896|NCT01238991|B7|Baseline|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
302897|NCT01238991|B6|Baseline|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302898|NCT01238991|B5|Baseline|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302899|NCT01238991|B4|Baseline|10 μg ACC-001+ (10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302900|NCT01238991|B3|Baseline|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
302901|NCT01238991|B2|Baseline|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302902|NCT01238991|B1|Baseline|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
302903|NCT01238991|P10|Participant Flow|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302904|NCT01238991|P9|Participant Flow|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302905|NCT01238991|P8|Participant Flow|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302906|NCT01238991|P7|Participant Flow|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
302907|NCT01238991|P6|Participant Flow|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302908|NCT01238991|P5|Participant Flow|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302909|NCT01238991|P4|Participant Flow|10 μg ACC-001+ (10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302910|NCT01238991|P3|Participant Flow|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
303027|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
302911|NCT01238991|P2|Participant Flow|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302912|NCT01238991|P1|Participant Flow|3 μg ACC-001+QS-21|A group of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
302913|NCT01238991|O10|Outcome|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
302914|NCT01238991|O9|Outcome|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302915|NCT01238991|O8|Outcome|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302916|NCT01238991|O7|Outcome|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
302917|NCT01238991|O6|Outcome|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302918|NCT01238991|O5|Outcome|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302919|NCT01238991|O4|Outcome|10 μg ACC-001+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302920|NCT01238991|O3|Outcome|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
302921|NCT01238991|O2|Outcome|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302922|NCT01238991|O1|Outcome|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
302923|NCT01238991|O10|Outcome|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
302924|NCT01238991|O9|Outcome|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302925|NCT01238991|O8|Outcome|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302926|NCT01238991|O7|Outcome|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
302927|NCT01238991|O6|Outcome|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302928|NCT01238991|O5|Outcome|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302929|NCT01238991|O4|Outcome|10 μg ACC-001+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302930|NCT01238991|O3|Outcome|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
302931|NCT01238991|O2|Outcome|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302932|NCT01238991|O1|Outcome|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
302933|NCT01238991|O10|Outcome|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
302934|NCT01238991|O9|Outcome|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302935|NCT01238991|O8|Outcome|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302936|NCT01238991|O7|Outcome|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
302937|NCT01238991|O6|Outcome|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302938|NCT01238991|O5|Outcome|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
308155|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
302939|NCT01238991|O4|Outcome|10 μg ACC-001+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302940|NCT01238991|O3|Outcome|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
302941|NCT01238991|O2|Outcome|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302942|NCT01238991|O1|Outcome|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
302943|NCT01238991|O10|Outcome|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
302944|NCT01238991|O9|Outcome|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302945|NCT01238991|O8|Outcome|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302946|NCT01238991|O7|Outcome|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
302947|NCT01238991|O6|Outcome|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302948|NCT01238991|O5|Outcome|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302949|NCT01238991|O4|Outcome|10 μg ACC-001+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302950|NCT01238991|O3|Outcome|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
302951|NCT01238991|O2|Outcome|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302952|NCT01238991|O1|Outcome|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
302953|NCT01238991|O10|Outcome|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
302954|NCT01238991|O9|Outcome|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302955|NCT01238991|O8|Outcome|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302956|NCT01238991|O7|Outcome|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
302957|NCT01238991|O6|Outcome|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302958|NCT01238991|O5|Outcome|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302959|NCT01238991|O4|Outcome|10 μg ACC-001+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302960|NCT01238991|O3|Outcome|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
302961|NCT01238991|O2|Outcome|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302962|NCT01238991|O1|Outcome|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
302963|NCT01238991|O10|Outcome|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
302964|NCT01238991|O9|Outcome|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302965|NCT01238991|O8|Outcome|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302966|NCT01238991|O7|Outcome|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
304395|NCT01234207|O1|Outcome|Control Spectacles|"Arm/Groups Outcome Measures are reported per intervention."
302967|NCT01238991|O6|Outcome|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302968|NCT01238991|O5|Outcome|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302969|NCT01238991|O4|Outcome|10 μg ACC-001+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302970|NCT01238991|O3|Outcome|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
302971|NCT01238991|O2|Outcome|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302972|NCT01238991|O1|Outcome|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
302973|NCT01238991|O6|Outcome|30 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302974|NCT01238991|O5|Outcome|30 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302975|NCT01238991|O4|Outcome|10 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302976|NCT01238991|O3|Outcome|10 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001(10 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302977|NCT01238991|O2|Outcome|3 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302978|NCT01238991|O1|Outcome|3 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
302979|NCT01238991|O6|Outcome|30 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302980|NCT01238991|O5|Outcome|30 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302981|NCT01238991|O4|Outcome|10 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302982|NCT01238991|O3|Outcome|10 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001(10 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302983|NCT01238991|O2|Outcome|3 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302984|NCT01238991|O1|Outcome|3 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
302985|NCT01238991|O6|Outcome|30 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302986|NCT01238991|O5|Outcome|30 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302987|NCT01238991|O4|Outcome|10 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302988|NCT01238991|O3|Outcome|10 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001(10 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302989|NCT01238991|O2|Outcome|3 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302990|NCT01238991|O1|Outcome|3 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
302991|NCT01238991|E7|Reported Event|Total|All participants
302992|NCT01238991|E6|Reported Event|30μg Control|A group of participants who received IM injection of adjuvant QS-21(50 μg) or PBS in the preceding studies and active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302993|NCT01238991|E5|Reported Event|30μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302994|NCT01238991|E4|Reported Event|10μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302995|NCT01238991|E3|Reported Event|10ug ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302996|NCT01238991|E2|Reported Event|3μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and acctive vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
302997|NCT01238991|E1|Reported Event|3μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
302998|NCT01238900|B1|Baseline|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
302999|NCT01238900|P1|Participant Flow|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
303000|NCT01238900|O1|Outcome|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
303001|NCT01238900|O1|Outcome|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
303002|NCT01238900|O1|Outcome|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
303003|NCT01238900|O1|Outcome|Per- Protocol Analysis of Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
303004|NCT01238900|O1|Outcome|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
303005|NCT01238900|E1|Reported Event|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
303006|NCT01238861|B7|Baseline|Total|Total of all reporting groups
303007|NCT01238861|B6|Baseline|EOS- Benralizumab, 100 mg|EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303008|NCT01238861|B5|Baseline|Non-eosinophil Phenotype (EOS-) Placebo|EOS- (defined as ELEN Index negative and FeNO <50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303009|NCT01238861|B4|Baseline|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303010|NCT01238861|B3|Baseline|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303011|NCT01238861|B2|Baseline|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303012|NCT01238861|B1|Baseline|Eosinophilic Phenotype (EOS+) Placebo|EOS+ (defined as ELEN Index [proprietary mathematical algorithm to predict sputum eosinophil’s greater than or equal to 2 percent] positive and/or FeNO [fraction of exhaled nitric oxide] greater than or equal to [>=] 50 parts per billion [ppb]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303013|NCT01238861|P6|Participant Flow|EOS- Benralizumab, 100 mg|EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303014|NCT01238861|P5|Participant Flow|Non-eosinophil Phenotype (EOS-) Placebo|EOS- (defined as ELEN Index negative and FeNO <50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303015|NCT01238861|P4|Participant Flow|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303016|NCT01238861|P3|Participant Flow|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303017|NCT01238861|P2|Participant Flow|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303018|NCT01238861|P1|Participant Flow|Eosinophilic Phenotype (EOS+) Placebo|EOS+ (defined as ELEN Index [proprietary mathematical algorithm to predict sputum eosinophil’s greater than or equal to 2 percent] positive and/or FeNO [fraction of exhaled nitric oxide] greater than or equal to [>=] 50 parts per billion [ppb]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303019|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
303020|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303021|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303022|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
303023|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
303024|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303025|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303026|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
303028|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303029|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303030|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
303031|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
303032|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303033|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303034|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
303035|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
303036|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303037|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303038|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
303039|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
303040|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303041|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303042|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
303043|NCT01238861|O6|Outcome|EOS- Benralizumab, 100 mg|EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303044|NCT01238861|O5|Outcome|EOS- Placebo|EOS- (defined as ELEN Index negative and FeNO <50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303045|NCT01238861|O4|Outcome|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303046|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303047|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303048|NCT01238861|O1|Outcome|EOS+ Placebo|EOS+ participants received two placebo injections subcutaneously.
303049|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
303050|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303051|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303052|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
303053|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
303054|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303055|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303056|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
303057|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
303058|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303059|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303060|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
303061|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
303062|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303063|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303064|NCT01238861|O1|Outcome|Placebo|EOS+ and EOS- participants received two placebo injections subcutaneously.
303065|NCT01238861|O6|Outcome|EOS- Benralizumab, 100 mg|EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303066|NCT01238861|O5|Outcome|EOS- Placebo|EOS- (defined as ELEN Index negative and FeNO <50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303067|NCT01238861|O4|Outcome|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303068|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303069|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303070|NCT01238861|O1|Outcome|EOS+ Placebo|EOS+ participants received two placebo injections subcutaneously.
303071|NCT01238861|O4|Outcome|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303072|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303073|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303074|NCT01238861|O1|Outcome|EOS+ Placebo|EOS+ participants received two placebo injections subcutaneously.
303075|NCT01238861|O3|Outcome|Benralizumab, 100 mg|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
303076|NCT01238861|O2|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303077|NCT01238861|O1|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303078|NCT01238861|O3|Outcome|Benralizumab, 100 mg|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
303079|NCT01238861|O2|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303080|NCT01238861|O1|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303081|NCT01238861|O4|Outcome|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303082|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303083|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303084|NCT01238861|O1|Outcome|EOS+ Placebo|EOS+ participants received two placebo injections subcutaneously.
303085|NCT01238861|O4|Outcome|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303086|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303087|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303088|NCT01238861|O1|Outcome|Eosinophilic Phenotype (EOS+) Placebo|EOS+ (defined as ELEN Index [proprietary mathematical algorithm to predict sputum eosinophil’s greater than or equal to 2 percent] positive and/or FeNO [fraction of exhaled nitric oxide] greater than or equal to [>=] 50 parts per billion [ppb]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
303089|NCT01238861|E6|Reported Event|EOS NEG Benralizumab 100 mg|EOS- participants received two benralizumab 50 mg injections subcutaneously.
303090|NCT01238861|E5|Reported Event|EOS NEG Placebo|EOS- participants received two placebo injections subcutaneously.
303091|NCT01238861|E4|Reported Event|EOS POS Benralizumab 100 mg|EOS+ participants received two benralizumab 50 mg injections subcutaneously.
303092|NCT01238861|E3|Reported Event|EOS POS Benralizumab 20 mg|EOS+ participants received single benralizumab 20 mg injection followed by a single placebo injection subcutaneously.
303093|NCT01238861|E2|Reported Event|EOS POS Benralizumab 2 mg|EOS+ participants received single benralizumab 2 milligram (mg) injection followed by a single placebo injection subcutaneously.
303094|NCT01238861|E1|Reported Event|EOS POS Placebo|EOS+ participants received two placebo injections subcutaneously.
303095|NCT01238848|B3|Baseline|Total|Total of all reporting groups
303096|NCT01238848|B2|Baseline|Normal|Normal saline (sodium chloride 0.9%) + albuterol
303097|NCT01238848|B1|Baseline|Hypertonic|Hypertonic saline (sodium chloride 0.3%) + albuterol
303098|NCT01238848|P2|Participant Flow|Normal|Normal saline (sodium chloride 0.9%) + albuterol
303099|NCT01238848|P1|Participant Flow|Hypertonic|Hypertonic saline (sodium chloride 0.3%) + albuterol
303100|NCT01238848|O2|Outcome|Normal|Normal saline (sodium chloride 0.9%) + albuterol
303101|NCT01238848|O1|Outcome|Hypertonic|Hypertonic saline (sodium chloride 0.3%) + albuterol
303102|NCT01238848|O2|Outcome|Normal|Normal saline (sodium chloride 0.9%) + albuterol
303103|NCT01238848|O1|Outcome|Hypertonic|Hypertonic saline (sodium chloride 0.3%) + albuterol
303104|NCT01238848|E2|Reported Event|Normal|Normal saline (sodium chloride 0.9%) + albuterol
303105|NCT01238848|E1|Reported Event|Hypertonic|Hypertonic saline (sodium chloride 0.3%) + albuterol
303106|NCT01238822|B1|Baseline|All Participants|All participants received 3 weekly doses of methylphenidate at a low dose (18 mg), medium dosage (27 mg or 36 mg depending on weight) and a high dosage (52 mg or 36 mg depending on weight) and another week of placebo. Patients took each dosage for 1 week and parents and teachers rated their behavior at the end of each week.
303107|NCT01238822|P1|Participant Flow|All Participants|All participants received 3 weekly doses of methylphenidate at a low dose (18 mg), medium dosage (27 mg or 36 mg depending on weight) and a high dosage (52 mg or 36 mg depending on weight) and another week of placebo. Patients took each dosage for 1 week and parents and teachers rated their behavior at the end of each week.
303108|NCT01238822|O4|Outcome|High Dosage|54 mg methylphenidate if >25 kg; 36 mg methylphenidate if < 25 kg.
303109|NCT01238822|O3|Outcome|Medium Dosage|36 mg methylphenidate if >25 kg; 27 mg methylphenidate if < 25 kg.
303110|NCT01238822|O2|Outcome|Low Dosage|18 mg methylphenidate
303111|NCT01238822|O1|Outcome|Placebo|placebo
303112|NCT01238822|E4|Reported Event|High Dosage|54 mg methylphenidate
303113|NCT01238822|E3|Reported Event|Medium Dosage|Medium Dosage: 36 mg methylphenidate
303114|NCT01238822|E2|Reported Event|Low Dosage|Low dose: 18 mg methylphenidate
303115|NCT01238822|E1|Reported Event|Placebo|
303116|NCT01238640|B1|Baseline|Overall Study|
303117|NCT01238640|P1|Participant Flow|Overall Study|
303118|NCT01238640|O3|Outcome|Nicorette Microtab 2 mg|A comparative 2 mg marketed nicotine product called Nicorette Microtab
303119|NCT01238640|O2|Outcome|STE 2 mg|"An experimental 2 mg nicotine product coded STE"
303120|NCT01238640|O1|Outcome|STD 2 mg|"An experimental 2 mg nicotine product coded STD"
303121|NCT01238640|O3|Outcome|Nicorette Microtab 2 mg|A comparative 2 mg marketed nicotine product called Nicorette Microtab
303122|NCT01238640|O2|Outcome|STE 2 mg|"An experimental 2 mg nicotine product coded STE"
303123|NCT01238640|O1|Outcome|STD 2 mg|"An experimental 2 mg nicotine product coded STD"
303124|NCT01238640|O3|Outcome|Nicorette Microtab 2 mg|A comparative 2 mg marketed nicotine product called Nicorette Microtab
303125|NCT01238640|O2|Outcome|STE 2 mg|"An experimental 2 mg nicotine product coded STE"
303126|NCT01238640|O1|Outcome|STD 2 mg|"An experimental 2 mg nicotine product coded STD"
303127|NCT01238640|O3|Outcome|Nicorette Microtab 2 mg|A comparative 2 mg marketed nicotine product called Nicorette Microtab
303128|NCT01238640|O2|Outcome|STE 2 mg|"An experimental 2 mg nicotine product coded STE"
303129|NCT01238640|O1|Outcome|STD 2 mg|"An experimental 2 mg nicotine product coded STD"
303130|NCT01238640|E3|Reported Event|Nicorette Microtab 2 mg|A comparative 2 mg marketed nicotine product called Nicorette Microtab
303131|NCT01238640|E2|Reported Event|STE 2 mg|"An experimental 2 mg nicotine product coded STE"
303132|NCT01238640|E1|Reported Event|STD 2 mg|"An experimental 2 mg nicotine product coded STD"
303133|NCT01238588|B1|Baseline|Sevelamer Carbonate (Renvela)|"Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.~Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines."
303134|NCT01238588|P1|Participant Flow|Sevelamer Carbonate (Renvela)|"Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.~Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines."
303135|NCT01238588|O1|Outcome|Sevelamer Carbonate (Renvela)|"Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.~Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines."
303136|NCT01238588|O1|Outcome|Sevelamer Carbonate (Renvela)|"Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.~Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines."
303137|NCT01238588|O1|Outcome|Sevelamer Carbonate (Renvela)|"Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.~Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines."
303138|NCT01238588|O1|Outcome|Sevelamer Carbonate (Renvela)|"Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.~Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines."
303139|NCT01238588|O1|Outcome|Sevelamer Carbonate (Renvela)|"Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.~Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines."
303140|NCT01238588|O1|Outcome|Sevelamer Carbonate (Renvela)|"Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.~Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines."
303141|NCT01238588|O1|Outcome|Sevelamer Carbonate (Renvela)|"Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.~Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines."
303186|NCT01238536|P2|Participant Flow|Epidural Local Anesthetic Injection|"Intervention: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.~Epidural local anesthetic injection: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe."
303142|NCT01238588|O1|Outcome|Sevelamer Carbonate (Renvela)|"Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.~Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines."
303143|NCT01238588|E1|Reported Event|Sevelamer Carbonate (Renvela)|"Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.~Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines."
303144|NCT01238575|B3|Baseline|Total|Total of all reporting groups
303145|NCT01238575|B2|Baseline|Inactive Placebo|placebo: Administered for up to 8 weeks.
303146|NCT01238575|B1|Baseline|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
303147|NCT01238575|P2|Participant Flow|Inactive Placebo|placebo: Administered for up to 8 weeks.
303148|NCT01238575|P1|Participant Flow|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
303149|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
303150|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
303151|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
303152|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
303153|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
303154|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
303155|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
303156|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
303157|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
303158|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
303159|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
303160|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
303161|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
303162|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
303163|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
303164|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
303165|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
303166|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
303167|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
303168|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
303169|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
303170|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
303171|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
303172|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
303173|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
303174|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
303175|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
303176|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
303177|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
303178|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
303179|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
303180|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
303181|NCT01238575|E2|Reported Event|Inactive Placebo|placebo: Administered for up to 8 weeks.
303182|NCT01238575|E1|Reported Event|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
303183|NCT01238536|B3|Baseline|Total|Total of all reporting groups
303184|NCT01238536|B2|Baseline|Epidural Local Anesthetic Injection|"Intervention: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.~Epidural local anesthetic injection: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe."
303185|NCT01238536|B1|Baseline|Epidural Steroid Injection|"Intervention: Epidural steroid with local anesthetic injection~2cc of .25 - 1% lidocaine and glucocorticoid (Kenalog 40-120 mg, depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg)in an opaque syringe.~Epidural steroid with local anesthetic injection: Epidural steroid injectate will be 2cc of 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.~Epidural steroid injection: Epidural steroid injectate will be 2cc of .25 - 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe."
303187|NCT01238536|P1|Participant Flow|Epidural Steroid Injection|"Intervention: Epidural steroid with local anesthetic injection~2cc of .25 - 1% lidocaine and glucocorticoid (Kenalog 40-120 mg, depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg)in an opaque syringe.~Epidural steroid with local anesthetic injection: Epidural steroid injectate will be 2cc of 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.~Epidural steroid injection: Epidural steroid injectate will be 2cc of .25 - 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe."
303188|NCT01238536|O2|Outcome|Epidural Local Anesthetic Injection|Intervention: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.
303189|NCT01238536|O1|Outcome|Epidural Steroid Injection|"Intervention: Epidural steroid with local anesthetic injection~2cc of .25 - 1% lidocaine and glucocorticoid (Kenalog 40-120 mg, depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg)"
303190|NCT01238536|O2|Outcome|Epidural Local Anesthetic Injection|Intervention: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.
303191|NCT01238536|O1|Outcome|Epidural Steroid Injection|"Intervention: Epidural steroid with local anesthetic injection~2cc of .25 - 1% lidocaine and glucocorticoid (Kenalog 40-120 mg, depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg)"
303192|NCT01238536|O2|Outcome|Epidural Local Anesthetic Injection|"Intervention: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.~Epidural local anesthetic injection: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe."
303193|NCT01238536|O1|Outcome|Epidural Steroid Injection|"Intervention: Epidural steroid with local anesthetic injection~2cc of .25 - 1% lidocaine and glucocorticoid (Kenalog 40-120 mg, depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg)in an opaque syringe.~Epidural steroid with local anesthetic injection: Epidural steroid injectate will be 2cc of 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.~Epidural steroid injection: Epidural steroid injectate will be 2cc of .25 - 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe."
303194|NCT01238536|O2|Outcome|Epidural Local Anesthetic Injection|"Intervention: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.~Epidural local anesthetic injection: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe."
303195|NCT01238536|O1|Outcome|Epidural Steroid Injection|"Intervention: Epidural steroid with local anesthetic injection~2cc of .25 - 1% lidocaine and glucocorticoid (Kenalog 40-120 mg, depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg)in an opaque syringe.~Epidural steroid with local anesthetic injection: Epidural steroid injectate will be 2cc of 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.~Epidural steroid injection: Epidural steroid injectate will be 2cc of .25 - 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe."
303196|NCT01238536|E2|Reported Event|Epidural Local Anesthetic Injection|"Intervention: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.~Epidural local anesthetic injection: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe."
303197|NCT01238536|E1|Reported Event|Epidural Steroid Injection|"Intervention: Epidural steroid with local anesthetic injection~2cc of .25 - 1% lidocaine and glucocorticoid (Kenalog 40-120 mg, depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg)in an opaque syringe.~Epidural steroid with local anesthetic injection: Epidural steroid injectate will be 2cc of 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.~Epidural steroid injection: Epidural steroid injectate will be 2cc of .25 - 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe."
303198|NCT01238471|B3|Baseline|Total|Total of all reporting groups
303199|NCT01238471|B2|Baseline|Oral Sucrose 5%|"Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization~sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks"
303200|NCT01238471|B1|Baseline|Propranolol|"Oral propranolol for premature infants allocated to this arm by randomization~propranolol: 2 mg per kg per day divided in 3 doses for 2-4 weeks"
303201|NCT01238471|P2|Participant Flow|Oral Sucrose 5%|"Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization~sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks"
303202|NCT01238471|P1|Participant Flow|Propranolol|"Oral propranolol for premature infants allocated to this arm by randomization~propranolol: 2 mg per kg per day divided in 3 doses for 2-4 weeks"
303203|NCT01238471|O2|Outcome|Oral Sucrose 5%|"Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization~sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks"
303204|NCT01238471|O1|Outcome|Propranolol|"Oral propranolol for premature infants allocated to this arm by randomization~propranolol: 2 mg per kg per day divided in 3 doses for 2-4 weeks"
303205|NCT01238471|E2|Reported Event|Oral Sucrose 5%|"Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization~sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks"
303206|NCT01238471|E1|Reported Event|Propranolol|"Oral propranolol for premature infants allocated to this arm by randomization~propranolol: 2 mg per kg per day divided in 3 doses for 2-4 weeks"
303207|NCT01238341|B1|Baseline|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
303390|NCT01237054|O1|Outcome|MGUS (Monoclonal Gammopathy of Undetermined Significance)|MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
303208|NCT01238341|P1|Participant Flow|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
303209|NCT01238341|O1|Outcome|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
303210|NCT01238341|O1|Outcome|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
303211|NCT01238341|O1|Outcome|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
303212|NCT01238341|O1|Outcome|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
303213|NCT01238341|E1|Reported Event|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
303214|NCT01238211|B1|Baseline|Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)|"INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m^2)on days 1-3, cytarabine IV (200 mg/m^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.~CONSOLIDATION THERAPY: high-dose cytarabine IV (patients < Age 60: 3000 mg/m^2, Age >= 1000 mg/m^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.~CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse."
303215|NCT01238211|P1|Participant Flow|Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)|"INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m^2)on days 1-3, cytarabine IV (200 mg/m^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.~CONSOLIDATION THERAPY: high-dose cytarabine IV (patients < Age 60: 3000 mg/m^2, Age >= 1000 mg/m^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.~CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse."
303216|NCT01238211|O1|Outcome|Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)|"INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m^2)on days 1-3, cytarabine IV (200 mg/m^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.~CONSOLIDATION THERAPY: high-dose cytarabine IV (patients < Age 60: 3000 mg/m^2, Age >= 1000 mg/m^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.~CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse."
303217|NCT01238211|E1|Reported Event|Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)|CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse.
303218|NCT01237678|B4|Baseline|Total|Total of all reporting groups
303219|NCT01237678|B3|Baseline|Phase II - Carboplatin + Etoposide|Carboplatin (AUC 5) was administered on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Drugs were administered for 6 cycles as tolerated.
303220|NCT01237678|B2|Baseline|Phase II - IMGN901 + Carboplatin + Etoposide|IMGN901 was administered at the RP2D determined in Phase I (112 mg/m2; later reduced to 90 mg/m2) on Days 1 and 8 of each 21-day cycle. Patients also received carboplatin (AUC 5) on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
303221|NCT01237678|B1|Baseline|Phase I - IMGN901 + Carboplatin + Etoposide|Participants received IMGN901 on Days 1 and 8 of a 21-day cycle. All patients also received carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle.The starting dose of IMGN901 was 60 mg/m2; dose escalation proceeded, as tolerated, through 75, 90, and 112 mg/m2. Carboplatin was originally dosed at an AUC 6 however due to poor tolerability this was reduced to an AUC of 5. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
303222|NCT01237678|P3|Participant Flow|Phase II - Carboplatin + Etoposide|Carboplatin (AUC 5) was administered on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Drugs were administered for 6 cycles as tolerated.
303223|NCT01237678|P2|Participant Flow|Phase II - IMGN901 + Carboplatin + Etoposide|IMGN901 was administered at the RP2D (recommended phase II dose) determined in Phase I (112 mg/m2; later reduced to 90 mg/m2) on Days 1 and 8 of each 21-day cycle. Patients also received carboplatin (AUC 5) on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
303224|NCT01237678|P1|Participant Flow|Phase I - IMGN901 + Carboplatin + Etoposide|Participants received IMGN901 on Days 1 and 8 of a 21-day cycle. All patients also received carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle.The starting dose of IMGN901 was 60 mg/m2; dose escalation proceeded, as tolerated, through 75, 90, and 112 mg/m2. Carboplatin was originally dosed at an AUC 6 however due to poor tolerability this was reduced to an AUC of 5. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
303246|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
303225|NCT01237678|O1|Outcome|Phase II - IMGN901 + Carboplatin + Etoposide|IMGN901 was administered at the RP2D determined in Phase I (112 mg/m2; later reduced to 90 mg/m2) on Days 1 and 8 of each 21-day cycle. Patients also received carboplatin (AUC 5) on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
303226|NCT01237678|O2|Outcome|Phase II - Carboplatin + Etoposide|Carboplatin (AUC 5) was administered on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Drugs were administered for 6 cycles as tolerated.
303227|NCT01237678|O1|Outcome|Phase II - IMGN901 + Carboplatin + Etoposide|IMGN901 was administered at the RP2D determined in Phase I (112 mg/m2; later reduced to 90 mg/m2) on Days 1 and 8 of each 21-day cycle. Patients also received carboplatin (AUC 5) on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
303228|NCT01237678|O1|Outcome|Phase II - IMGN901 + Carboplatin + Etoposide|IMGN901 was administered at the RP2D determined in Phase I (112 mg/m2; later reduced to 90 mg/m2) on Days 1 and 8 of each 21-day cycle. Patients also received carboplatin (AUC 5) on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
303229|NCT01237678|O3|Outcome|Phase II - Carboplatin + Etoposide|Carboplatin (AUC 5) was administered on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Drugs were administered for 6 cycles as tolerated.
303230|NCT01237678|O2|Outcome|Phase II - IMGN901 + Carboplatin + Etoposide|IMGN901 was administered at the RP2D determined in Phase I (112 mg/m2; later reduced to 90 mg/m2) on Days 1 and 8 of each 21-day cycle. Patients also received carboplatin (AUC 5) on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
303231|NCT01237678|O1|Outcome|Phase I - IMGN901 + Carboplatin + Etoposide|Participants received IMGN901 on Days 1 and 8 of a 21-day cycle. All patients also received carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle.The starting dose of IMGN901 was 60 mg/m2; dose escalation proceeded, as tolerated, through 75, 90, and 112 mg/m2. Carboplatin was originally dosed at an AUC 6 however due to poor tolerability this was reduced to an AUC of 5. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
303232|NCT01237678|O1|Outcome|Phase I - IMGN901 + Carboplatin + Etoposide|Participants received IMGN901 on Days 1 and 8 of a 21-day cycle. All patients also received carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle.The starting dose of IMGN901 was 60 mg/m2; dose escalation proceeded, as tolerated, through 75, 90, and 112 mg/m2. Carboplatin was originally dosed at an AUC 6 however due to poor tolerability this was reduced to an AUC of 5. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
303233|NCT01237678|O1|Outcome|Phase II - IMGN901 + Carboplatin + Etoposide|IMGN901 was administered at the RP2D determined in Phase I (112 mg/m2; later reduced to 90 mg/m2) on Days 1 and 8 of each 21-day cycle. Patients also received carboplatin (AUC 5) on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
303234|NCT01237678|O5|Outcome|IMGN901 112 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2|
303235|NCT01237678|O4|Outcome|IMGN901 90 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2|
303236|NCT01237678|O3|Outcome|IMGN901 75 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2|
303237|NCT01237678|O2|Outcome|IMGN901 75 mg/m2 + Carboplatin AUC 6 + Etoposide 100 mg/m2|
303238|NCT01237678|O1|Outcome|IMGN901 60 mg/m2 + Carboplatin AUC 6 + Etoposide 100 mg/m2|
303239|NCT01237678|E3|Reported Event|Phase II - Carboplatin + Etoposide|Carboplatin (AUC 5) was administered on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Drugs were administered for 6 cycles as tolerated.
303240|NCT01237678|E2|Reported Event|Phase II - IMGN901 + Carboplatin + Etoposide|IMGN901 was administered at the RP2D determined in Phase I (112 mg/m2; later reduced to 90 mg/m2) on Days 1 and 8 of each 21-day cycle. Patients also received carboplatin (AUC 5) on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
303241|NCT01237678|E1|Reported Event|Phase I - IMGN901 + Carboplatin + Etoposide|Participants received IMGN901 on Days 1 and 8 of a 21-day cycle. All patients also received carboplatin on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. The starting dose of IMGN901 was 60 mg/m2; dose escalation proceeded, as tolerated, through 75, 90, and 112 mg/m2. Carboplatin was originally dosed at an AUC 6 however due to poor tolerability this was reduced to an AUC of 5. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
303242|NCT01237613|B1|Baseline|Artelon|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
303243|NCT01237613|P1|Participant Flow|Artelon|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
303244|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
303245|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
303388|NCT01237054|O3|Outcome|MM (Multiple Myeloma)|Multiple myeloma is a plasma cell neoplasm.
303247|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
303248|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patientschronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
303249|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
303250|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
303251|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
303252|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
303253|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
303254|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
303255|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
303256|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
303257|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
303258|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
303259|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
303260|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
303261|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
303262|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
303263|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
303264|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
303265|NCT01237613|E1|Reported Event|Artelon|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
303266|NCT01237353|B1|Baseline|Betaine Hydrochloride and Rabeprazole|"betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5~Rabeprazole : rabeprazole po daily x 5 days"
303267|NCT01237353|P1|Participant Flow|Betaine Hydrochloride and Rabeprazole|"betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5~Rabeprazole : rabeprazole po daily x 5 days"
303268|NCT01237353|O1|Outcome|Betaine Hydrochloride and Rabeprazole|"betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5~Rabeprazole : rabeprazole po daily x 5 days"
303269|NCT01237353|O1|Outcome|Betaine Hydrochloride and Rabeprazole|"betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5~Rabeprazole : rabeprazole po daily x 5 days"
303270|NCT01237353|E1|Reported Event|Betaine Hydrochloride and Rabeprazole|"betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5~Rabeprazole : rabeprazole po daily x 5 days"
303271|NCT01237340|B1|Baseline|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
303272|NCT01237340|P1|Participant Flow|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
303273|NCT01237340|O1|Outcome|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
304396|NCT01234207|O2|Outcome|Test Spectacles|"Arm/Groups Outcome Measures are reported per intervention."
303274|NCT01237340|O2|Outcome|GH Treatment-Experienced|Growth hormone (GH) Treatment-experienced participants were those who had undergone treatment with the freeze-dried formulation of Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
303275|NCT01237340|O1|Outcome|GH Treatment-Naive|Growth hormone (GH) Treatment-Naive participants were those who did not receive any prior treatment with Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
303276|NCT01237340|O2|Outcome|GH Treatment-Experienced|Growth hormone (GH) Treatment-experienced participants were those who had undergone treatment with the freeze-dried formulation of Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
303277|NCT01237340|O1|Outcome|GH Treatment-Naive|Growth hormone (GH) Treatment-Naive participants were those who did not receive any prior treatment with Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
303278|NCT01237340|O2|Outcome|GH Treatment-Experienced|Growth hormone (GH) Treatment-experienced participants were those who had undergone treatment with the freeze-dried formulation of Saizen® before initiation of the trial. Growth hormone (GH) Treatment-experienced participants were those who had undergone treatment with the freeze-dried formulation of Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
303279|NCT01237340|O1|Outcome|GH Treatment-Naive|Growth hormone (GH) Treatment-Naive participants were those who did not receive any prior treatment with Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
303280|NCT01237340|O1|Outcome|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
303281|NCT01237340|O1|Outcome|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
303282|NCT01237340|E1|Reported Event|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
303283|NCT01237327|B3|Baseline|Total|Total of all reporting groups
303284|NCT01237327|B2|Baseline|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
303285|NCT01237327|B1|Baseline|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
303286|NCT01237327|P2|Participant Flow|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
303287|NCT01237327|P1|Participant Flow|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
303288|NCT01237327|O2|Outcome|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
303289|NCT01237327|O1|Outcome|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
303290|NCT01237327|O2|Outcome|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
303291|NCT01237327|O1|Outcome|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
303292|NCT01237327|O2|Outcome|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
303293|NCT01237327|O1|Outcome|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
303294|NCT01237327|O2|Outcome|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
303295|NCT01237327|O1|Outcome|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
303296|NCT01237327|O2|Outcome|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
303297|NCT01237327|O1|Outcome|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
303298|NCT01237327|E2|Reported Event|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
303299|NCT01237327|E1|Reported Event|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
303300|NCT01237301|B3|Baseline|Total|Total of all reporting groups
303301|NCT01237301|B2|Baseline|SMBG Group|"Use SMBG 4 to 7 times a day for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
303302|NCT01237301|B1|Baseline|CGM Group|"Wear an unblinded CGM for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
303303|NCT01237301|P2|Participant Flow|SMBG Group|"Use SMBG 4 to 7 times a day for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
303304|NCT01237301|P1|Participant Flow|CGM Group|"Wear an unblinded CGM for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
303305|NCT01237301|O2|Outcome|SMBG Group|"Use SMBG 4 to 7 times a day for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
303306|NCT01237301|O1|Outcome|CGM Group|"Wear an unblinded CGM for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
303307|NCT01237301|E2|Reported Event|SMBG Group|"Use SMBG 4 to 7 times a day for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
303308|NCT01237301|E1|Reported Event|CGM Group|"Wear an unblinded CGM for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
303309|NCT01237223|B7|Baseline|Total|Total of all reporting groups
303310|NCT01237223|B6|Baseline|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
303311|NCT01237223|B5|Baseline|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
303312|NCT01237223|B4|Baseline|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
303313|NCT01237223|B3|Baseline|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
303314|NCT01237223|B2|Baseline|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
303315|NCT01237223|B1|Baseline|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period.
303316|NCT01237223|P6|Participant Flow|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
303317|NCT01237223|P5|Participant Flow|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
303318|NCT01237223|P4|Participant Flow|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
303319|NCT01237223|P3|Participant Flow|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
303320|NCT01237223|P2|Participant Flow|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
303321|NCT01237223|P1|Participant Flow|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In single blind run-in (4 weeks) and double blind treatment period (8 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily.
303322|NCT01237223|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
303323|NCT01237223|O5|Outcome|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
303324|NCT01237223|O4|Outcome|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
304397|NCT01234207|O1|Outcome|Control Spectacles|"Arm/Groups Outcome Measures are reported per intervention."
303325|NCT01237223|O3|Outcome|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
303326|NCT01237223|O2|Outcome|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
303327|NCT01237223|O1|Outcome|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period.
303328|NCT01237223|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
303329|NCT01237223|O5|Outcome|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
303330|NCT01237223|O4|Outcome|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
303331|NCT01237223|O3|Outcome|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
303332|NCT01237223|O2|Outcome|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
303333|NCT01237223|O1|Outcome|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period.
303334|NCT01237223|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
303335|NCT01237223|O5|Outcome|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
303336|NCT01237223|O4|Outcome|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
303337|NCT01237223|O3|Outcome|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
303338|NCT01237223|O2|Outcome|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
303339|NCT01237223|O1|Outcome|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period.
303340|NCT01237223|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
303341|NCT01237223|O5|Outcome|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
303389|NCT01237054|O2|Outcome|SMM (Smoldering Multiple Myeloma)|Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder.
303342|NCT01237223|O4|Outcome|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
303343|NCT01237223|O3|Outcome|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
303344|NCT01237223|O2|Outcome|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
303345|NCT01237223|O1|Outcome|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period.
303346|NCT01237223|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
303347|NCT01237223|O5|Outcome|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
303348|NCT01237223|O4|Outcome|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
303349|NCT01237223|O3|Outcome|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
303350|NCT01237223|O2|Outcome|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
303351|NCT01237223|O1|Outcome|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind treatment period.
303352|NCT01237223|E7|Reported Event|Placebo (Single-Blind run-in Period)|In order to adequately blind the study,patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In single blind run-in period (4 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily.
303353|NCT01237223|E6|Reported Event|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
303354|NCT01237223|E5|Reported Event|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
303355|NCT01237223|E4|Reported Event|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
303356|NCT01237223|E3|Reported Event|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
303357|NCT01237223|E2|Reported Event|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
303358|NCT01237223|E1|Reported Event|Placebo (Double Blind)|In order to adequately blind the study,patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In double blind treatment period (8 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily.
303359|NCT01237197|B3|Baseline|Total|Total of all reporting groups
303360|NCT01237197|B2|Baseline|Placebo Injection|"Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.~Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study."
303361|NCT01237197|B1|Baseline|Exenatide|"Exenatide 5 micrograms (mcg): administered with injection twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)~Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study."
303362|NCT01237197|P2|Participant Flow|Placebo Injection|"Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.~Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study."
303363|NCT01237197|P1|Participant Flow|Exenatide|"Exenatide 5 micrograms (mcg): administered with injection twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)~Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study."
303364|NCT01237197|O2|Outcome|Placebo Injection|"Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.~Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study."
303365|NCT01237197|O1|Outcome|Exenatide|"Exenatide 5 micrograms (mcg): administered with injection twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)~Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study."
303366|NCT01237197|E2|Reported Event|Placebo Injection|"Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.~Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study."
303367|NCT01237197|E1|Reported Event|Exenatide|"Exenatide 5 micrograms (mcg): administered with injection twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)~Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study."
303368|NCT01237080|B3|Baseline|Total|Total of all reporting groups
303369|NCT01237080|B2|Baseline|GlideScope|50 persons beeing intubated using the GlideScope.
303370|NCT01237080|B1|Baseline|Fastrach|50 persons beeing intubated using the Fastrach.
303371|NCT01237080|P2|Participant Flow|GlideScope|50 persons beeing intubated using the GlideScope.
303372|NCT01237080|P1|Participant Flow|Fastrach|50 persons beeing intubated using the Fastrach.
303373|NCT01237080|O2|Outcome|GlideScope|50 persons beeing intubated using the GlideScope.
303374|NCT01237080|O1|Outcome|Fastrach|50 persons beeing intubated using the Fastrach.
303375|NCT01237080|O2|Outcome|GlideScope|50 persons beeing intubated using the GlideScope.
303376|NCT01237080|O1|Outcome|Fastrach|50 persons beeing intubated using the Fastrach.
303377|NCT01237080|E2|Reported Event|GlideScope|50 persons beeing intubated using the GlideScope.
303378|NCT01237080|E1|Reported Event|Fastrach|50 persons beeing intubated using the Fastrach.
303379|NCT01237054|B1|Baseline|Imaging in MGUS, SMM, and MM|"Participants will have three imaging studies on separate days: a standard positron emission tomography/computed tomography scan (18-FDG PET/CT), a PET/CT scan with an experimental sodium fluoride-based drug (18-NaF PET/CT), and magnetic resonance imaging (DCE-MRI).~18-NaF PET: The patient will patient will receive 5mCi of F-18 NaF IV bolus, followed by a ~20 ml saline (sodium chloride IV infusion 0.9% w/v) flush over a period of ~20 seconds. Serial dynamic imaging (2 minutes/bed position) will be obtained over a 1-hour period. The patient will be permitted an imaging break until a static PET/CT is performed beginning at 2-hours post F-18 NaF injection. DCE-MRI: An FDA approved gadolinium chelate (e.g. Magnevist, Berlex Laboratories, NJ, USA) will be administered intravenously at 3 cc/sec using an automated pump injector (Medrad, Pittsburgh, PA, USA).18-FDG PET/CT: The 18F-FDG injection procedure will be injected and be followed by a ~20 ml saline flush over a period of ~20 sec."
303380|NCT01237054|P1|Participant Flow|Imaging in MGUS, SMM, and MM|"Participants will have three imaging studies on separate days: a standard positron emission tomography/computed tomography scan (18-FDG PET/CT), a PET/CT scan with an experimental sodium fluoride-based drug (18-NaF PET/CT), and magnetic resonance imaging (DCE-MRI).~18-NaF PET: The patient will patient will receive 5mCi of F-18 NaF IV bolus, followed by a ~20 ml saline (sodium chloride IV infusion 0.9% w/v) flush over a period of ~20 seconds. Serial dynamic imaging (2 minutes/bed position) will be obtained over a 1-hour period. The patient will be permitted an imaging break until a static PET/CT is performed beginning at 2-hours post F-18 NaF injection. DCE-MRI: An FDA approved gadolinium chelate (e.g. Magnevist, Berlex Laboratories, NJ, USA) will be administered intravenously at 3 cc/sec using an automated pump injector (Medrad, Pittsburgh, PA, USA).18-FDG PET/CT: The 18F-FDG injection procedure will be injected and be followed by a ~20 ml saline flush over a period of ~20 sec."
303381|NCT01237054|O2|Outcome|SMM (Smoldering Multiple Myeloma)/MM (Multiple Myeloma)|Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder. Multiple myeloma is a plasma cell neoplasm.
303382|NCT01237054|O1|Outcome|MGUS (Monoclonal Gammopathy of Undetermined Significance)|MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
303383|NCT01237054|O2|Outcome|SMM (Smoldering Multiple Myeloma)/MM (Multiple Myeloma)|Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder. Multiple myeloma is a plasma cell neoplasm.
303384|NCT01237054|O1|Outcome|MGUS (Monoclonal Gammopathy of Undetermined Significance)|MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
303385|NCT01237054|O3|Outcome|MM (Multiple Myeloma)|Multiple myeloma is a plasma cell neoplasm.
303386|NCT01237054|O2|Outcome|SMM (Smoldering Multiple Myeloma)|Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder.
303387|NCT01237054|O1|Outcome|MGUS (Monoclonal Gammopathy of Undetermined Significance)|MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
303391|NCT01237054|O2|Outcome|SMM (Smoldering Multiple Myeloma)/MM (Multiple Myeloma)|Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder. Multiple myeloma is a plasma cell neoplasm.
303392|NCT01237054|O1|Outcome|MGUS (Monoclonal Gammopathy of Undetermined Significance)|MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
303393|NCT01237054|O3|Outcome|MM (Multiple Myeloma)|Multiple myeloma is a plasma cell neoplasm.
303394|NCT01237054|O2|Outcome|SMM (Smoldering Multiple Myeloma)|Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder.
303395|NCT01237054|O1|Outcome|MGUS (Monoclonal Gammopathy of Undetermined Significance)|MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
303396|NCT01237054|O3|Outcome|MM (Multiple Myeloma)|Multiple myeloma is a plasma cell neoplasm.
303397|NCT01237054|O2|Outcome|SMM (Smoldering Multiple Myeloma)|Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder.
303398|NCT01237054|O1|Outcome|MGUS (Monoclonal Gammopathy of Undetermined Significance)|MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
303399|NCT01237054|E1|Reported Event|Imaging in MGUS, SMM, and MM|"Participants will have three imaging studies on separate days: a standard positron emission tomography/computed tomography scan (18-FDG PET/CT), a PET/CT scan with an experimental sodium fluoride-based drug (18-NaF PET/CT), and magnetic resonance imaging (DCE-MRI).~18-NaF PET: The patient will patient will receive 5mCi of F-18 NaF IV bolus, followed by a ~20 ml saline (sodium chloride IV infusion 0.9% w/v) flush over a period of ~20 seconds. Serial dynamic imaging (2 minutes/bed position) will be obtained over a 1-hour period. The patient will be permitted an imaging break until a static PET/CT is performed beginning at 2-hours post F-18 NaF injection. DCE-MRI: An FDA approved gadolinium chelate (e.g. Magnevist, Berlex Laboratories, NJ, USA) will be administered intravenously at 3 cc/sec using an automated pump injector (Medrad, Pittsburgh, PA, USA).18-FDG PET/CT: The 18F-FDG injection procedure will be injected and be followed by a ~20 ml saline flush over a period of ~20 sec."
303400|NCT01236768|B3|Baseline|Total|Total of all reporting groups
303401|NCT01236768|B2|Baseline|Levora|hormonal oral contraceptive
303402|NCT01236768|B1|Baseline|AG200-15|"Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)~AG200-15: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week patch free period."
303403|NCT01236768|P2|Participant Flow|Levora|hormonal oral contraceptive
303404|NCT01236768|P1|Participant Flow|AG200-15|Transdermal contraceptive delivery system (TCDS)
303405|NCT01236768|O1|Outcome|AG200-15|"Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)~AG200-15: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week patch free period."
303406|NCT01236768|O2|Outcome|Levora|"oral contraceptive containing 150mcg of LNG and 30mcg of EE~Levora: One tablet of Levora will be taken each day for a 28 day cycle."
303407|NCT01236768|O1|Outcome|AG200-15|"Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)~AG200-15: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week patch free period."
303408|NCT01236768|O1|Outcome|AG200-15|"Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)~AG200-15: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week patch free period."
303409|NCT01236768|O2|Outcome|Levora|"oral contraceptive containing 150mcg of LNG and 30mcg of EE~Levora: One tablet of Levora will be taken each day for a 28 day cycle."
303410|NCT01236768|O1|Outcome|AG200-15|"Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)~AG200-15: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week patch free period."
303411|NCT01236768|O2|Outcome|Levora|"oral contraceptive containing 150mcg of LNG and 30mcg of EE~Levora: One tablet of Levora will be taken each day for a 28 day cycle."
303412|NCT01236768|O1|Outcome|AG200-15|"Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)~AG200-15: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week patch free period."
303413|NCT01236768|O2|Outcome|Levora|hormonal oral contraceptive
303414|NCT01236768|O1|Outcome|AG200-15|"Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)~AG200-15: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week patch free period."
303415|NCT01236768|E2|Reported Event|Levora|"oral contraceptive containing 150mcg of LNG and 30mcg of EE~Levora: One tablet of Levora will be taken each day for a 28 day cycle."
303416|NCT01236768|E1|Reported Event|AG200-15|"Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)~AG200-15: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week patch free period."
303417|NCT01236742|B4|Baseline|Total|Total of all reporting groups
303418|NCT01236742|B3|Baseline|Single-vision Glasses|"Children who are currently wearing single-vision spectacles in the daytime for correcting their refractive errors will continue with the current treatment and serve as the second control group~single-vision glasses: daily wear of spectacle glasses to correct vision"
303419|NCT01236742|B2|Baseline|Ortho-k Lenses|"Children who are currently wearing ortho-k lenses at night for the correction of refractive errors will continue with the current treatment and serve as the first control group~ortho-k lenses: nightly wear of orthokeratology lenses to correct vision"
303420|NCT01236742|B1|Baseline|Single-vision Glasses and Ortho-k Lenses|"Children who are currently wearing ortho-k lenses at night for correction of refractive errors will be switched to wear single-vision glasses for the first 7 months and then switched back to ortho-k lenses for the next 7 months~ortho-k lenses: nightly wear of orthokeratology lenses to correct vision~single-vision glasses: daily wear of spectacle glasses to correct vision"
303567|NCT01236326|O1|Outcome|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
303421|NCT01236742|P3|Participant Flow|Single-vision Glasses|"Children who are currently wearing single-vision spectacles in the daytime for correcting their refractive errors will continue with the current treatment and serve as the second control group~single-vision glasses: daily wear of spectacle glasses to correct vision"
303422|NCT01236742|P2|Participant Flow|Ortho-k Lenses|"Children who are currently wearing ortho-k lenses at night for the correction of refractive errors will continue with the current treatment and serve as the first control group~ortho-k lenses: nightly wear of orthokeratology lenses to correct vision"
303423|NCT01236742|P1|Participant Flow|Single-vision Glasses and Ortho-k Lenses|"Children who are currently wearing ortho-k lenses at night for correction of refractive errors will be switched to wear single-vision glasses for the first 7 months and then switched back to ortho-k lenses for the next 7 months~ortho-k lenses: nightly wear of orthokeratology lenses to correct vision~single-vision glasses: daily wear of spectacle glasses to correct vision"
303424|NCT01236742|O3|Outcome|Single-vision Glasses|"Children who are currently wearing single-vision spectacles in the daytime for correcting their refractive errors will continue with the current treatment and serve as the second control group~single-vision glasses: daily wear of spectacle glasses to correct vision"
303425|NCT01236742|O2|Outcome|Ortho-k Lenses|"Children who are currently wearing ortho-k lenses at night for the correction of refractive errors will continue with the current treatment and serve as the first control group~ortho-k lenses: nightly wear of orthokeratology lenses to correct vision"
303426|NCT01236742|O1|Outcome|Single-vision Glasses and Ortho-k Lenses|"Children who are currently wearing ortho-k lenses at night for correction of refractive errors will be switched to wear single-vision glasses for the first 7 months and then switched back to ortho-k lenses for the next 7 months~ortho-k lenses: nightly wear of orthokeratology lenses to correct vision~single-vision glasses: daily wear of spectacle glasses to correct vision"
303427|NCT01236742|O3|Outcome|Single-vision Glasses|"Children who are currently wearing single-vision spectacles in the daytime for correcting their refractive errors will continue with the current treatment and serve as the second control group~single-vision glasses: daily wear of spectacle glasses to correct vision"
303428|NCT01236742|O2|Outcome|Ortho-k Lenses|"Children who are currently wearing ortho-k lenses at night for the correction of refractive errors will continue with the current treatment and serve as the first control group~ortho-k lenses: nightly wear of orthokeratology lenses to correct vision"
303429|NCT01236742|O1|Outcome|Single-vision Glasses and Ortho-k Lenses|"Children who are currently wearing ortho-k lenses at night for correction of refractive errors will be switched to wear single-vision glasses for the first 7 months and then switched back to ortho-k lenses for the next 7 months~ortho-k lenses: nightly wear of orthokeratology lenses to correct vision~single-vision glasses: daily wear of spectacle glasses to correct vision"
303430|NCT01236742|E3|Reported Event|Single-vision Glasses|"Children who are currently wearing single-vision spectacles in the daytime for correcting their refractive errors will continue with the current treatment and serve as the second control group~single-vision glasses: daily wear of spectacle glasses to correct vision"
303431|NCT01236742|E2|Reported Event|Ortho-k Lenses|"Children who are currently wearing ortho-k lenses at night for the correction of refractive errors will continue with the current treatment and serve as the first control group~ortho-k lenses: nightly wear of orthokeratology lenses to correct vision"
303432|NCT01236742|E1|Reported Event|Single-vision Glasses and Ortho-k Lenses|"Children who are currently wearing ortho-k lenses at night for correction of refractive errors will be switched to wear single-vision glasses for the first 7 months and then switched back to ortho-k lenses for the next 7 months~ortho-k lenses: nightly wear of orthokeratology lenses to correct vision~single-vision glasses: daily wear of spectacle glasses to correct vision"
303433|NCT01236573|B12|Baseline|Total|Total of all reporting groups
303434|NCT01236573|B11|Baseline|Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303435|NCT01236573|B10|Baseline|Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303436|NCT01236573|B9|Baseline|Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303437|NCT01236573|B8|Baseline|Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303438|NCT01236573|B7|Baseline|Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303439|NCT01236573|B6|Baseline|Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303440|NCT01236573|B5|Baseline|Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303441|NCT01236573|B4|Baseline|Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303442|NCT01236573|B3|Baseline|Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303443|NCT01236573|B2|Baseline|Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303444|NCT01236573|B1|Baseline|Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303445|NCT01236573|P11|Participant Flow|Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303446|NCT01236573|P10|Participant Flow|Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303447|NCT01236573|P9|Participant Flow|Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303448|NCT01236573|P8|Participant Flow|Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303449|NCT01236573|P7|Participant Flow|Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303450|NCT01236573|P6|Participant Flow|Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303568|NCT01236326|O2|Outcome|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
303451|NCT01236573|P5|Participant Flow|Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303452|NCT01236573|P4|Participant Flow|Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303453|NCT01236573|P3|Participant Flow|Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303454|NCT01236573|P2|Participant Flow|Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303455|NCT01236573|P1|Participant Flow|Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303456|NCT01236573|O11|Outcome|Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303457|NCT01236573|O10|Outcome|Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303458|NCT01236573|O9|Outcome|Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303459|NCT01236573|O8|Outcome|Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303460|NCT01236573|O7|Outcome|Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303461|NCT01236573|O6|Outcome|Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303462|NCT01236573|O5|Outcome|Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303569|NCT01236326|O1|Outcome|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
303463|NCT01236573|O4|Outcome|Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303464|NCT01236573|O3|Outcome|Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303465|NCT01236573|O2|Outcome|Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303466|NCT01236573|O1|Outcome|Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303467|NCT01236573|O11|Outcome|Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303468|NCT01236573|O10|Outcome|Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303469|NCT01236573|O9|Outcome|Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303470|NCT01236573|O8|Outcome|Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303471|NCT01236573|O7|Outcome|Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303472|NCT01236573|O6|Outcome|Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303473|NCT01236573|O5|Outcome|Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303474|NCT01236573|O4|Outcome|Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303570|NCT01236326|O2|Outcome|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
308156|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mgqd (once daily) subcutaneous injection
303475|NCT01236573|O3|Outcome|Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303476|NCT01236573|O2|Outcome|Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303477|NCT01236573|O1|Outcome|Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303478|NCT01236573|O1|Outcome|All Phase I Participants|All phase I participants who received at least one dose intravenously of CD8 + TIL expressing IL-12 in Groups 1-4, and Bulk TIL expressing IL-12 in Groups 5-10 (i.e., CD8 + TIL expressing IL-12 1x10^6, CD8 + TIL expressing IL-12 3x10^6, CD8 + TIL expressing IL-12 3x10^7, CD8 + TIL expressing IL-12 3x10^7, Bulk TIL expressing IL-12 1x10^7, Bulk TIL expressing IL-12 3x10^7, Bulk TIL expressing IL-12 1x10^8, Bulk TIL expressing IL-12 3x10^8, Bulk TIL expressing IL-12 1x10^9, and Bulk TIL expressing IL-12 3x10^9) respectively.
303479|NCT01236573|E11|Reported Event|Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303480|NCT01236573|E10|Reported Event|Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303481|NCT01236573|E9|Reported Event|Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303482|NCT01236573|E8|Reported Event|Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303483|NCT01236573|E7|Reported Event|Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303484|NCT01236573|E6|Reported Event|Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303485|NCT01236573|E5|Reported Event|Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303486|NCT01236573|E4|Reported Event|Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303571|NCT01236326|O1|Outcome|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
303487|NCT01236573|E3|Reported Event|Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303488|NCT01236573|E2|Reported Event|Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303489|NCT01236573|E1|Reported Event|Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
303490|NCT01236534|B3|Baseline|Total|Total of all reporting groups
303491|NCT01236534|B2|Baseline|Sugar Pill|Placebo : matching placebo twice daily for 21 days.
303492|NCT01236534|B1|Baseline|Lubiprostone|Lubiprostone : 24 mcg twice daily for 21 days.
303493|NCT01236534|P2|Participant Flow|Sugar Pill|Placebo : matching placebo twice daily for 21 days.
303494|NCT01236534|P1|Participant Flow|Lubiprostone|Lubiprostone : 24 mcg twice daily for 21 days.
303495|NCT01236534|O2|Outcome|Sugar Pill|Placebo : matching placebo twice daily for 21 days.
303496|NCT01236534|O1|Outcome|Lubiprostone|Lubiprostone : 24 mcg twice daily for 21 days.
303497|NCT01236534|O2|Outcome|Sugar Pill|Placebo : matching placebo twice daily for 21 days.
303498|NCT01236534|O1|Outcome|Lubiprostone|Lubiprostone : 24 mcg twice daily for 21 days.
303499|NCT01236534|E2|Reported Event|Sugar Pill|Placebo : matching placebo twice daily for 21 days.
303500|NCT01236534|E1|Reported Event|Lubiprostone|Lubiprostone : 24 mcg twice daily for 21 days.
303501|NCT01236391|B1|Baseline|PCI-32765|PCI-32765: 560 mg daily
303502|NCT01236391|P1|Participant Flow|PCI-32765|Participants received 560 mg daily
303503|NCT01236391|O1|Outcome|EORTC QLQ-C30|Participants received PCI-32765 560 mg daily and completed the EORTC QLQ-C30 questionnaire at Pre-Dose and at Cycle 5
303504|NCT01236391|O2|Outcome|PCI-45227 (Metabolite)- Day 8|PCI-32765: 560 mg daily
303505|NCT01236391|O1|Outcome|PCI-32765 - Day 8|PCI-32765: 560 mg daily
303506|NCT01236391|O1|Outcome|PCI-32765|PCI-32765: 560 mg daily
303507|NCT01236391|O1|Outcome|PCI-32765|PCI-32765: 560 mg daily
303508|NCT01236391|E1|Reported Event|PCI-32765|PCI-32765: 560 mg daily
303509|NCT01236378|B1|Baseline|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
303510|NCT01236378|P1|Participant Flow|Sirolimus|Sirolimus, 1 milligram (mg) tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last pharmacokinetic (PK) sample collection.
303511|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
303512|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
303513|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
303514|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
303515|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
303516|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
303517|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
303518|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
303519|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
303572|NCT01236326|E2|Reported Event|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
303520|NCT01236378|E1|Reported Event|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
303521|NCT01236365|B3|Baseline|Total|Total of all reporting groups
303522|NCT01236365|B2|Baseline|Placebo|Atorvastatin Placebo: 10 or 20 mg daily
303523|NCT01236365|B1|Baseline|Atorvastatin|Atorvastatin: 10 or 20 mg daily
303524|NCT01236365|P2|Participant Flow|Placebo|Placebo: 10 or 20 mg daily
303525|NCT01236365|P1|Participant Flow|Atorvastatin|Atorvastatin: 10 or 20 mg daily
303526|NCT01236365|O4|Outcome|Placebo hsCRP at 6 Months|
303527|NCT01236365|O3|Outcome|Placebo hsCRP at Randomization|
303528|NCT01236365|O2|Outcome|Atorvastatin hsCRP at 6 Months|
303529|NCT01236365|O1|Outcome|Atorvastatin hsCRP at Randomization|
303530|NCT01236365|O4|Outcome|Placebo LDL-C at 6 Months|
303531|NCT01236365|O3|Outcome|Placebo LDL-C at Randomization|
303532|NCT01236365|O2|Outcome|Atorvastatin LDL-C at 6 Months|
303533|NCT01236365|O1|Outcome|Atorvastatin LDL-C at Randomization|
303534|NCT01236365|E2|Reported Event|Placebo|Atorvastatin Placebo: 10 or 20 mg daily
303535|NCT01236365|E1|Reported Event|Atorvastatin|Atorvastatin: 10 or 20 mg daily
303536|NCT01236339|B3|Baseline|Total|Total of all reporting groups
303537|NCT01236339|B2|Baseline|LVP (Large Volume Paracentesis)|"Large Volume Paracentesis~*A subject may be crossed-over from large volume paracentesis to TIPS with GORE® VIATORR® TIPS Endoprosthesis if the subject has completed their six month study visit and has met the criteria for cross-over (LVP failure)."
303538|NCT01236339|B1|Baseline|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
303539|NCT01236339|P2|Participant Flow|LVP (Large Volume Paracentesis)|"Large Volume Paracentesis~*A subject may be crossed-over from large volume paracentesis to TIPS with GORE® VIATORR® TIPS Endoprosthesis if the subject has completed their six month study visit and has met the criteria for cross-over (LVP failure)"
303540|NCT01236339|P1|Participant Flow|TIPS|TIPS with GORE® VIATORR® TIPS Endoprosthesis
303541|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
303542|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
303543|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
303544|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
303545|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
303546|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
303547|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
303548|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
303549|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
303550|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
303551|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
303552|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
303553|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
303554|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
303555|NCT01236339|E2|Reported Event|LVP (Large Volume Paracentesis)|"Large Volume Paracentesis~*A subject may be crossed-over from large volume paracentesis to TIPS with GORE® VIATORR® TIPS Endoprosthesis if the subject has completed their six month study visit and has met the criteria for cross-over (LVP failure)."
303556|NCT01236339|E1|Reported Event|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
303557|NCT01236326|B3|Baseline|Total|Total of all reporting groups
303558|NCT01236326|B2|Baseline|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
303559|NCT01236326|B1|Baseline|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
303560|NCT01236326|P2|Participant Flow|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
303561|NCT01236326|P1|Participant Flow|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
303562|NCT01236326|O2|Outcome|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
303563|NCT01236326|O1|Outcome|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
303564|NCT01236326|O2|Outcome|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
303565|NCT01236326|O1|Outcome|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
303566|NCT01236326|O2|Outcome|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
303573|NCT01236326|E1|Reported Event|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
303574|NCT01236300|B1|Baseline|nCLE System|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).
303575|NCT01236300|P1|Participant Flow|nCLE System|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).
303576|NCT01236300|O1|Outcome|nCLE System (Stage 2)|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL). Stage 2 assessed whether the specific criteria defiend in Stage 1 could identify pancreatic cystic neoplasms (PCN).
303577|NCT01236300|O1|Outcome|nCLE System (Stage 2)|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL). Stage 2 assessed whether the specific criteria defiend in Stage 1 could identify pancreatic cystic neoplasms (PCN).
303578|NCT01236300|O1|Outcome|nCLE System (Stage 2)|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL). Stage 2 assessed whether the specific criteria defiend in Stage 1 could identify pancreatic cystic neoplasms (PCN).
303579|NCT01236300|O1|Outcome|nCLE System|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).
303580|NCT01236300|O1|Outcome|nCLE System (Stage 2)|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL). Stage 2 assessed whether the specific criteria defiend in Stage 1 could identify pancreatic cystic neoplasms (PCN).
303581|NCT01236300|E1|Reported Event|nCLE System|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).
303582|NCT01236196|B3|Baseline|Total|Total of all reporting groups
303583|NCT01236196|B2|Baseline|Arm 2 - Telephone Education|"Telephone pain education~Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
303584|NCT01236196|B1|Baseline|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management~Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
303585|NCT01236196|P2|Participant Flow|Arm 2 - Telephone Education|"Telephone pain education~Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
303586|NCT01236196|P1|Participant Flow|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management~Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
303587|NCT01236196|O2|Outcome|Arm 2 - Telephone Education|"Telephone pain education~Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
303588|NCT01236196|O1|Outcome|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management~Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
303589|NCT01236196|O2|Outcome|Arm 2 - Telephone Education|"Telephone pain education~Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
303590|NCT01236196|O1|Outcome|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management~Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
303591|NCT01236196|O2|Outcome|Arm 2 - Telephone Education|"Telephone pain education~Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
303592|NCT01236196|O1|Outcome|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management~Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
303593|NCT01236196|O2|Outcome|Arm 2 - Telephone Education|"Telephone pain education~Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
303594|NCT01236196|O1|Outcome|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management~Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
303595|NCT01236196|E2|Reported Event|Arm 2 - Telephone Education|"Telephone pain education~Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
303596|NCT01236196|E1|Reported Event|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management~Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
303597|NCT01236170|B1|Baseline|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
303598|NCT01236170|P1|Participant Flow|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
303599|NCT01236170|O1|Outcome|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
303600|NCT01236170|O1|Outcome|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
303601|NCT01236170|O1|Outcome|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
303602|NCT01236170|O1|Outcome|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
303603|NCT01236170|E1|Reported Event|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
303604|NCT01236118|B4|Baseline|Total|Total of all reporting groups
303717|NCT01236053|O1|Outcome|Incident Penile Cancer Patients|Patients with incident penile cancer defined from READ/OXMIS codes in the years 1995-2008
303605|NCT01236118|B3|Baseline|160 mg LY2439821|Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 Q2W subcutaneous injection for the first 3 doses then Q4W until Week 44.
303606|NCT01236118|B2|Baseline|80 mg LY2439821|Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 Q1W subcutaneous injection for the first 3 doses and then Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
303607|NCT01236118|B1|Baseline|30 mg LY2439821|Included participants from 30 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection Q1W for the first 3 doses Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
303608|NCT01236118|P3|Participant Flow|160 mg LY2439821|Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44.
303609|NCT01236118|P2|Participant Flow|80 mg LY2439821|Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
303610|NCT01236118|P1|Participant Flow|30 mg LY2439821|Included participants from 30 milligrams (mg) group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection once every week (Q1W) for the first 3 doses and once every 2 weeks (Q2W) until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection once every 4 weeks (Q4W) until Week 44.
303611|NCT01236118|O3|Outcome|160 mg LY2439821|Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44.
303612|NCT01236118|O2|Outcome|80 mg LY2439821|Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 Q1W subcutaneous injection for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
303613|NCT01236118|O1|Outcome|30 mg LY2439821|Included participants from 30 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
303614|NCT01236118|E3|Reported Event|160 mg LY2439821|Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44.
303615|NCT01236118|E2|Reported Event|80 mg LY2439821|Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
303616|NCT01236118|E1|Reported Event|30 mg LY2439821|Included participants from 30 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
303617|NCT01236105|B1|Baseline|LY2624803|"Participants received each of the following 3 study treatments:~LY2624803 Alone Morning Dosing: Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once at approximately 0800 hours following an overnight fast.~LY2624803 Morning Dosing Plus Activated Charcoal: Participants received 6 mg LY2624803 po once at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.~LY2624803 Alone Evening Dosing: Participants received 6 mg LY2624803 alone po once at approximately 2200 hours following a 4-hour fast."
303618|NCT01236105|P1|Participant Flow|LY2624803|"Participants received each of the following 3 study treatments:~LY2624803 Alone Morning Dosing: Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once at approximately 0800 hours following an overnight fast.~LY2624803 Morning Dosing Plus Activated Charcoal: Participants received 6 mg LY2624803 po once at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.~LY2624803 Alone Evening Dosing: Participants received 6 mg LY2624803 alone po once at approximately 2200 hours following a 4-hour fast."
303619|NCT01236105|O3|Outcome|LY2624803 Alone Evening Dosing|Participants received 6 mg LY2624803 alone po QD at approximately 2200 hours following a 4-hour fast.
303620|NCT01236105|O2|Outcome|LY2624803 Morning Dosing Plus Activated Charcoal|Participants received 6 mg LY2624803 po QD at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.
303621|NCT01236105|O1|Outcome|LY2624803 Alone Morning Dosing|Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once (QD) at approximately 0800 hours following an overnight fast.
303622|NCT01236105|O3|Outcome|LY2624803 Alone Evening Dosing|Participants received 6 mg LY2624803 alone po QD at approximately 2200 hours following a 4-hour fast.
303751|NCT01236053|O1|Outcome|Incident Lung Cancer Patients|Patients with incident lung cancer defined from READ/OXMIS codes in the years 1995-2008
303623|NCT01236105|O2|Outcome|LY2624803 Morning Dosing Plus Activated Charcoal|Participants received 6 mg LY2624803 po QD at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.
303624|NCT01236105|O1|Outcome|LY2624803 Alone Morning Dosing|Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once (QD) at approximately 0800 hours following an overnight fast.
303625|NCT01236105|O3|Outcome|LY2624803 Alone Evening Dosing|Participants received 6 mg LY2624803 alone po QD at approximately 2200 hours following a 4-hour fast.
303626|NCT01236105|O2|Outcome|LY2624803 Morning Dosing Plus Activated Charcoal|Participants received 6 mg LY2624803 po QD at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.
303627|NCT01236105|O1|Outcome|LY2624803 Alone Morning Dosing|Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once (QD) at approximately 0800 hours following an overnight fast.
303628|NCT01236105|E3|Reported Event|LY2624803 Evening Dosing|LY2624803 Alone Evening Dosing: Participants received 6 mg LY2624803 alone po once at approximately 2200 hours following a 4-hour fast.
303629|NCT01236105|E2|Reported Event|LY2624803 Morning Dosing + Activated Charcoal|LY2624803 Morning Dosing Plus Activated Charcoal: Participants received 6 mg LY2624803 po once at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.
303630|NCT01236105|E1|Reported Event|LY2624803 Morning Dosing|LY2624803 Alone Morning Dosing: Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once at approximately 0800 hours following an overnight fast.
303631|NCT01236053|B23|Baseline|Total|Total of all reporting groups
303632|NCT01236053|B22|Baseline|Renal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303633|NCT01236053|B21|Baseline|Renal Cancer: Cases|Incidence of renal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303634|NCT01236053|B20|Baseline|Pancreatic Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303635|NCT01236053|B19|Baseline|Pancreatic Cancer: Cases|Incidence of pancreatic cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303636|NCT01236053|B18|Baseline|Other Nervous System Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303637|NCT01236053|B17|Baseline|Other Nervous System Cancer: Cases|Incidence of other nervous system cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303638|NCT01236053|B16|Baseline|Bladder Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303639|NCT01236053|B15|Baseline|Bladder Cancer: Cases|Incidence of bladder cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303640|NCT01236053|B14|Baseline|Penile Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303819|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
303641|NCT01236053|B13|Baseline|Penile Cancer: Cases|Incidence of penile cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303642|NCT01236053|B12|Baseline|Breast Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303643|NCT01236053|B11|Baseline|Breast Cancer: Cases|Incidence of breast cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303644|NCT01236053|B10|Baseline|Bone/Joint Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303645|NCT01236053|B9|Baseline|Bone/Joint Cancer: Cases|Incidence of bone/joint cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303646|NCT01236053|B8|Baseline|Lung Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303647|NCT01236053|B7|Baseline|Lung Cancer: Cases|Incidence of lung cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303648|NCT01236053|B6|Baseline|Anal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303649|NCT01236053|B5|Baseline|Anal Cancer: Cases|Incidence of anal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303650|NCT01236053|B4|Baseline|Stomach Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303651|NCT01236053|B3|Baseline|Stomach Cancer: Cases|Incidence of stomach cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303652|NCT01236053|B2|Baseline|All-Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303653|NCT01236053|B1|Baseline|All-Cancer: Cases|Incidence of all cancers defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303820|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
303654|NCT01236053|P22|Participant Flow|Renal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303655|NCT01236053|P21|Participant Flow|Renal Cancer: Cases|Incidence of renal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303656|NCT01236053|P20|Participant Flow|Pancreatic Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303657|NCT01236053|P19|Participant Flow|Pancreatic Cancer: Cases|Incidence of pancreatic cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303658|NCT01236053|P18|Participant Flow|Other Nervous System Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303659|NCT01236053|P17|Participant Flow|Other Nervous System Cancer: Cases|Incidence of other nervous system cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303660|NCT01236053|P16|Participant Flow|Bladder Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303661|NCT01236053|P15|Participant Flow|Bladder Cancer: Cases|Incidence of bladder cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303662|NCT01236053|P14|Participant Flow|Penile Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303663|NCT01236053|P13|Participant Flow|Penile Cancer: Cases|Incidence of penile cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303664|NCT01236053|P12|Participant Flow|Breast Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303665|NCT01236053|P11|Participant Flow|Breast Cancer: Cases|Incidence of breast cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303666|NCT01236053|P10|Participant Flow|Bone/Joint Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303667|NCT01236053|P9|Participant Flow|Bone/Joint Cancer: Cases|Incidence of bone/joint cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303668|NCT01236053|P8|Participant Flow|Lung Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303669|NCT01236053|P7|Participant Flow|Lung Cancer: Cases|Incidence of lung cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303670|NCT01236053|P6|Participant Flow|Anal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303671|NCT01236053|P5|Participant Flow|Anal Cancer: Cases|Incidence of anal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303672|NCT01236053|P4|Participant Flow|Stomach Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303673|NCT01236053|P3|Participant Flow|Stomach Cancer: Cases|Incidence of stomach cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303674|NCT01236053|P2|Participant Flow|All-Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303675|NCT01236053|P1|Participant Flow|All-Cancer: Cases|Incidence of all cancers defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303676|NCT01236053|O2|Outcome|Matched Controls for Incident Renal Cancer Patients|Cancer-free control patients risk set matched with incident renal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303677|NCT01236053|O1|Outcome|Incident Renal Cancer Patients|Patients with incident renal cancer defined from READ/OXMIS codes in the years 1995-2008
303678|NCT01236053|O2|Outcome|Matched Controls for Incident Renal Cancer Patients|Cancer-free control patients risk set matched with incident renal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303679|NCT01236053|O1|Outcome|Incident Renal Cancer Patients|Patients with incident renal cancer defined from READ/OXMIS codes in the years 1995-2008
303680|NCT01236053|O2|Outcome|Matched Controls for Incident Renal Cancer Patients|Cancer-free control patients risk set matched with incident renal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303681|NCT01236053|O1|Outcome|Incident Renal Cancer Patients|Patients with incident renal cancer defined from READ/OXMIS codes in the years 1995-2008
303682|NCT01236053|O2|Outcome|Matched Controls for Incident Renal Cancer Patients|Cancer-free control patients risk set matched with incident renal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303683|NCT01236053|O1|Outcome|Incident Renal Cancer Patients|Patients with incident renal cancer defined from READ/OXMIS codes in the years 1995-2008
303684|NCT01236053|O2|Outcome|Matched Controls for Incident Renal Cancer Patients|Cancer-free control patients risk set matched with incident renal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303685|NCT01236053|O1|Outcome|Incident Renal Cancer Patients|Patients with incident renal cancer defined from READ/OXMIS codes in the years 1995-2008
303686|NCT01236053|O2|Outcome|Matched Controls for Incident Pancreatic Cancer Patients|Cancer-free control patients risk set matched with incident pancreatic cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303687|NCT01236053|O1|Outcome|Incident Pancreatic Cancer Patients|Patients with incident pancreatic cancer defined from READ/OXMIS codes in the years 1995-2008
303688|NCT01236053|O2|Outcome|Matched Controls for Incident Pancreatic Cancer Patients|Cancer-free control patients risk set matched with incident pancreatic cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303689|NCT01236053|O1|Outcome|Incident Pancreatic Cancer Patients|Patients with incident pancreatic cancer defined from READ/OXMIS codes in the years 1995-2008
303690|NCT01236053|O2|Outcome|Matched Controls for Incident Pancreatic Cancer Patients|Cancer-free control patients risk set matched with incident pancreatic cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303691|NCT01236053|O1|Outcome|Incident Pancreatic Cancer Patients|Patients with incident pancreatic cancer defined from READ/OXMIS codes in the years 1995-2008
303692|NCT01236053|O2|Outcome|Matched Controls for Incident Pancreatic Cancer Patients|Cancer-free control patients risk set matched with incident pancreatic cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303693|NCT01236053|O1|Outcome|Incident Pancreatic Cancer Patients|Patients with incident pancreatic cancer defined from READ/OXMIS codes in the years 1995-2008
303694|NCT01236053|O2|Outcome|Matched Controls for Incident Pancreatic Cancer Patients|Cancer-free control patients risk set matched with incident pancreatic cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303695|NCT01236053|O1|Outcome|Incident Pancreatic Cancer Patients|Patients with incident pancreatic cancer defined from READ/OXMIS codes in the years 1995-2008
303696|NCT01236053|O2|Outcome|Matched Controls for Incident ONS Cancer Patients|Cancer-free control patients risk set matched with incident other nervous system cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303697|NCT01236053|O1|Outcome|Incident Other Nervous System Cancer Patients|Patients with incident other nervous system cancer defined from READ/OXMIS codes in the years 1995-2008
303698|NCT01236053|O2|Outcome|Matched Controls for Incident ONS Cancer Patients|Cancer-free control patients risk set matched with incident other nervous system cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303699|NCT01236053|O1|Outcome|Incident Other Nervous System Cancer Patients|Patients with incident other nervous system cancer defined from READ/OXMIS codes in the years 1995-2008
303700|NCT01236053|O2|Outcome|Matched Controls for Incident ONS Cancer Patients|Cancer-free control patients risk set matched with incident other nervous system cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303701|NCT01236053|O1|Outcome|Incident Other Nervous System Cancer Patients|Patients with incident other nervous system cancer defined from READ/OXMIS codes in the years 1995-2008
303702|NCT01236053|O2|Outcome|Matched Controls for Incident ONS Cancer Patients|Cancer-free control patients risk set matched with incident other nervous system cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303703|NCT01236053|O1|Outcome|Incident Other Nervous System Cancer Patients|Patients with incident other nervous system cancer defined from READ/OXMIS codes in the years 1995-2008
303704|NCT01236053|O2|Outcome|Matched Controls for Incident ONS Cancer Patients|Cancer-free control patients risk set matched with incident other nervous system cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303705|NCT01236053|O1|Outcome|Incident Other Nervous System Cancer Patients|Patients with incident other nervous system cancer defined from READ/OXMIS codes in the years 1995-2008
303706|NCT01236053|O2|Outcome|Matched Controls for Incident Bladder Cancer Patients|Cancer-free control patients risk set matched with incident bladder cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303707|NCT01236053|O1|Outcome|Incident Bladder Cancer Patients|Patients with incident bladder cancer defined from READ/OXMIS codes in the years 1995-2008
303708|NCT01236053|O2|Outcome|Matched Controls for Incident Bladder Cancer Patients|Cancer-free control patients risk set matched with incident bladder cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303709|NCT01236053|O1|Outcome|Incident Bladder Cancer Patients|Patients with incident bladder cancer defined from READ/OXMIS codes in the years 1995-2008
303710|NCT01236053|O2|Outcome|Matched Controls for Incident Bladder Cancer Patients|Cancer-free control patients risk set matched with incident bladder cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303711|NCT01236053|O1|Outcome|Incident Bladder Cancer Patients|Patients with incident bladder cancer defined from READ/OXMIS codes in the years 1995-2008
303712|NCT01236053|O2|Outcome|Matched Controls for Incident Bladder Cancer Patients|Cancer-free control patients risk set matched with incident bladder cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303713|NCT01236053|O1|Outcome|Incident Bladder Cancer Patients|Patients with incident bladder cancer defined from READ/OXMIS codes in the years 1995-2008
303714|NCT01236053|O2|Outcome|Matched Controls for Incident Bladder Cancer Patients|Cancer-free control patients risk set matched with incident bladder cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303715|NCT01236053|O1|Outcome|Incident Bladder Cancer Patients|Patients with incident bladder cancer defined from READ/OXMIS codes in the years 1995-2008
303716|NCT01236053|O2|Outcome|Matched Controls for Incident Penile Cancer Patients|Cancer-free control patients risk set matched with incident penile cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303718|NCT01236053|O2|Outcome|Matched Controls for Incident Penile Cancer Patients|Cancer-free control patients risk set matched with incident penile cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303719|NCT01236053|O1|Outcome|Incident Penile Cancer Patients|Patients with incident penile cancer defined from READ/OXMIS codes in the years 1995-2008
303720|NCT01236053|O2|Outcome|Matched Controls for Incident Penile Cancer Patients|Cancer-free control patients risk set matched with incident penile cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303721|NCT01236053|O1|Outcome|Incident Penile Cancer Patients|Patients with incident penile cancer defined from READ/OXMIS codes in the years 1995-2008
303722|NCT01236053|O2|Outcome|Matched Controls for Incident Penile Cancer Patients|Cancer-free control patients risk set matched with incident penile cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303723|NCT01236053|O1|Outcome|Incident Penile Cancer Patients|Patients with incident penile cancer defined from READ/OXMIS codes in the years 1995-2008
303724|NCT01236053|O2|Outcome|Matched Controls for Incident Penile Cancer Patients|Cancer-free control patients risk set matched with incident penile cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303725|NCT01236053|O1|Outcome|Incident Penile Cancer Patients|Patients with incident penile cancer defined from READ/OXMIS codes in the years 1995-2008
303726|NCT01236053|O2|Outcome|Matched Controls for Incident Breast Cancer Patients|Cancer-free control patients risk set matched with incident breast cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303727|NCT01236053|O1|Outcome|Incident Breast Cancer Patients|Patients with incident breast cancer defined from READ/OXMIS codes in the years 1995-2008
303728|NCT01236053|O2|Outcome|Matched Controls for Incident Breast Cancer Patients|Cancer-free control patients risk set matched with incident breast cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303729|NCT01236053|O1|Outcome|Incident Breast Cancer Patients|Patients with incident breast cancer defined from READ/OXMIS codes in the years 1995-2008
303730|NCT01236053|O2|Outcome|Matched Controls for Incident Breast Cancer Patients|Cancer-free control patients risk set matched with incident breast cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303731|NCT01236053|O1|Outcome|Incident Breast Cancer Patients|Patients with incident breast cancer defined from READ/OXMIS codes in the years 1995-2008
303732|NCT01236053|O2|Outcome|Controls|Controls
303733|NCT01236053|O1|Outcome|Cases|Cases
303734|NCT01236053|O2|Outcome|Matched Controls for Incident Breast Cancer Patients|Cancer-free control patients risk set matched with incident breast cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303735|NCT01236053|O1|Outcome|Incident Breast Cancer Patients|Patients with incident breast cancer defined from READ/OXMIS codes in the years 1995-2008
303736|NCT01236053|O2|Outcome|Matched Controls for Incident Bone/Joint Cancer Patients|Cancer-free control patients risk set matched with incident bone/joint cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303737|NCT01236053|O1|Outcome|Incident Bone/Joint Cancer Patients|Patients with incident bone/joint cancer defined from READ/OXMIS codes in the years 1995-2008
303738|NCT01236053|O2|Outcome|Matched Controls for Incident Bone/Joint Cancer Patients|Cancer-free control patients risk set matched with incident bone/joint cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303739|NCT01236053|O1|Outcome|Incident Bone/Joint Cancer Patients|Patients with incident bone/joint cancer defined from READ/OXMIS codes in the years 1995-2008
303740|NCT01236053|O2|Outcome|Matched Controls for Incident Bone/Joint Cancer Patients|Cancer-free control patients risk set matched with incident bone/joint cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303741|NCT01236053|O1|Outcome|Incident Bone/Joint Cancer Patients|Patients with incident bone/joint cancer defined from READ/OXMIS codes in the years 1995-2008
303742|NCT01236053|O2|Outcome|Matched Controls for Incident Bone/Joint Cancer Patients|Cancer-free control patients risk set matched with incident bone/joint cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303743|NCT01236053|O1|Outcome|Incident Bone/Joint Cancer Patients|Patients with incident bone/joint cancer defined from READ/OXMIS codes in the years 1995-2008
303744|NCT01236053|O2|Outcome|Matched Controls for Incident Bone/Joint Cancer Patients|Cancer-free control patients risk set matched with incident bone/joint cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303745|NCT01236053|O1|Outcome|Incident Bone/Joint Cancer Patients|Patients with incident bone/joint cancer defined from READ/OXMIS codes in the years 1995-2008
303746|NCT01236053|O2|Outcome|Matched Controls for Incident Lung Cancer Patients|Cancer-free control patients risk set matched with incident lung cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice
303747|NCT01236053|O1|Outcome|Incident Lung Cancer Patients|Patients with incident lung cancer defined from READ/OXMIS codes in the years 1995-2008
303748|NCT01236053|O2|Outcome|Matched Controls for Incident Lung Cancer Patients|Cancer-free control patients risk set matched with incident lung cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303749|NCT01236053|O1|Outcome|Incident Lung Cancer Patients|Patients with incident lung cancer defined from READ/OXMIS codes in the years 1995-2008
303750|NCT01236053|O2|Outcome|Matched Controls for Incident Lung Cancer Patients|Cancer-free control patients risk set matched with incident lung cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303752|NCT01236053|O2|Outcome|Matched Controls for Incident Lung Cancer Patients|Cancer-free control patients risk set matched with incident lung cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303753|NCT01236053|O1|Outcome|Incident Lung Cancer Patients|Patients with incident lung cancer defined from READ/OXMIS codes in the years 1995-2008
303754|NCT01236053|O2|Outcome|Matched Controls for Incident Lung Cancer Patients|Cancer-free control patients risk set matched with incident lung cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303755|NCT01236053|O1|Outcome|Incident Lung Cancer Patients|Patients with incident lung cancer defined from READ/OXMIS codes in the years 1995-2008
303756|NCT01236053|O2|Outcome|Matched Controls for Incident Anal Cancer Patients|Cancer-free control patients risk set matched with incident anal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303757|NCT01236053|O1|Outcome|Incident Anal Cancer Patients|Patients with incident anal cancer defined from READ/OXMIS codes in the years 1995-2008
303758|NCT01236053|O2|Outcome|Matched Controls for Incident Anal Cancer Patients|Cancer-free control patients risk set matched with incident anal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303759|NCT01236053|O1|Outcome|Incident Anal Cancer Patients|Patients with incident anal cancer defined from READ/OXMIS codes in the years 1995-2008
303760|NCT01236053|O2|Outcome|Matched Controls for Incident Anal Cancer Patients|Cancer-free control patients risk set matched with incident anal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303761|NCT01236053|O1|Outcome|Incident Anal Cancer Patients|Patients with incident anal cancer defined from READ/OXMIS codes in the years 1995-2008
303762|NCT01236053|O2|Outcome|Matched Controls for Incident Anal Cancer Patients|Cancer-free control patients risk set matched with incident anal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303763|NCT01236053|O1|Outcome|Incident Anal Cancer Patients|Patients with incident anal cancer defined from READ/OXMIS codes in the years 1995-2008
303764|NCT01236053|O2|Outcome|Matched Controls for Incident Anal Cancer Patients|Cancer-free control patients risk set matched with incident anal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303765|NCT01236053|O1|Outcome|Incident Anal Cancer Patients|Patients with incident anal cancer defined from READ/OXMIS codes in the years 1995-2008
303766|NCT01236053|O2|Outcome|Matched Controls for Incident Stomach Cancer Patients|Cancer-free control patients risk set matched with incident stomach cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303767|NCT01236053|O1|Outcome|Incident Stomach Cancer Patients|Patients with incident stomach cancer defined from READ/OXMIS codes in the years 1995-2008
303768|NCT01236053|O2|Outcome|Matched Controls for Incident Stomach Cancer Patients|Cancer-free control patients risk set matched with incident stomach cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303769|NCT01236053|O1|Outcome|Incident Stomach Cancer Patients|Patients with incident stomach cancer defined from READ/OXMIS codes in the years 1995-2008
303770|NCT01236053|O2|Outcome|Matched Controls for Incident Stomach Cancer Patients|Cancer-free control patients risk set matched with incident stomach cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303771|NCT01236053|O1|Outcome|Incident Stomach Cancer Patients|Patients with incident stomach cancer defined from READ/OXMIS codes in the years 1995-2008
303772|NCT01236053|O2|Outcome|Matched Controls for Incident Stomach Cancer Patients|Cancer-free control patients risk set matched with incident stomach cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303773|NCT01236053|O1|Outcome|Incident Stomach Cancer Patients|Patients with incident stomach cancer defined from READ/OXMIS codes in the years 1995-2008
303774|NCT01236053|O2|Outcome|Matched Controls for Incident Stomach Cancer Patients|Cancer-free control patients risk set matched with incident stomach cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303775|NCT01236053|O1|Outcome|Incident Stomach Cancer Patients|Patients with incident stomach cancer defined from READ/OXMIS codes in the years 1995-2008
303776|NCT01236053|O2|Outcome|Matched Controls for Incident All-cancer Patients|Cancer-free control patients risk set matched with incident all-cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303777|NCT01236053|O1|Outcome|Incident All-cancer Patients|Patients with any type of incident cancer defined from READ/OXMIS codes in the years 1995-2008
303778|NCT01236053|O2|Outcome|Matched Controls for Incident All-cancer Patients|Cancer-free control patients risk set matched with incident all-cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303779|NCT01236053|O1|Outcome|Incident All-cancer Patients|Patients with any type of incident cancer defined from READ/OXMIS codes in the years 1995-2008
303780|NCT01236053|O2|Outcome|Matched Controls for Incident All-cancer Patients|Cancer-free control patients risk set matched with incident all-cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303781|NCT01236053|O1|Outcome|Incident All-cancer Patients|Patients with any type of incident cancer defined from READ/OXMIS codes in the years 1995-2008
303782|NCT01236053|O2|Outcome|Matched Controls for Incident All-cancer Patients|Cancer-free control patients risk set matched with incident all-cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303783|NCT01236053|O1|Outcome|Incident All-cancer Patients|Patients with any type of incident cancer defined from READ/OXMIS codes in the years 1995-2008
304398|NCT01234207|E2|Reported Event|Test Spectacles|"Arm/Groups Adverse Events are reported per intervention"
303784|NCT01236053|O2|Outcome|Matched Controls for Incident All-cancer Patients|Cancer-free control patients risk set matched with incident all-cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
303785|NCT01236053|O1|Outcome|Incident All-cancer Patients|Patients with any type of incident cancer defined from READ/OXMIS codes in the years 1995-2008
303786|NCT01236053|E22|Reported Event|Renal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303787|NCT01236053|E21|Reported Event|Renal Cancer: Cases|Incidence of renal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303788|NCT01236053|E20|Reported Event|Pancreatic Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303789|NCT01236053|E19|Reported Event|Pancreatic Cancer: Cases|Incidence of pancreatic cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303790|NCT01236053|E18|Reported Event|Other Nervous System Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303791|NCT01236053|E17|Reported Event|Other Nervous System Cancer: Cases|Incidence of other nervous system cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303792|NCT01236053|E16|Reported Event|Bladder Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303793|NCT01236053|E15|Reported Event|Bladder Cancer: Cases|Incidence of bladder cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303794|NCT01236053|E14|Reported Event|Penile Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303795|NCT01236053|E13|Reported Event|Penile Cancer: Cases|Incidence of penile cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303796|NCT01236053|E12|Reported Event|Breast Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303797|NCT01236053|E11|Reported Event|Breast Cancer: Cases|Incidence of breast cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
304399|NCT01234207|E1|Reported Event|Control Spectacles|"Arm/Groups Adverse Events are reported per intervention"
303798|NCT01236053|E10|Reported Event|Bone/Joint Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303799|NCT01236053|E9|Reported Event|Bone/Joint Cancer: Cases|Incidence of bone/joint cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303800|NCT01236053|E8|Reported Event|Lung Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303801|NCT01236053|E7|Reported Event|Lung Cancer: Cases|Incidence of lung cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303802|NCT01236053|E6|Reported Event|Anal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303803|NCT01236053|E5|Reported Event|Anal Cancer: Cases|Incidence of anal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303804|NCT01236053|E4|Reported Event|Stomach Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303805|NCT01236053|E3|Reported Event|Stomach Cancer: Cases|Incidence of stomach cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303806|NCT01236053|E2|Reported Event|All-Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
303807|NCT01236053|E1|Reported Event|All-Cancer: Cases|Incidence of all cancers defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
303808|NCT01236001|B3|Baseline|Total|Total of all reporting groups
303809|NCT01236001|B2|Baseline|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
303810|NCT01236001|B1|Baseline|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
303811|NCT01236001|P2|Participant Flow|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
303812|NCT01236001|P1|Participant Flow|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
303813|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® treatment on/after enrollment.
303814|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
303815|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
303816|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
303817|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
303818|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
303821|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
303822|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
303823|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
303824|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
303825|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
303826|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
303827|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
303828|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
303829|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
303830|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
303831|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
303832|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
303833|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
303834|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
303835|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
303836|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
303837|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
303838|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
303839|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
303840|NCT01236001|E1|Reported Event|Vimpat® Treatment|Reported Adverse Events is a combination of both patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® treatment on/after enrollment.
303841|NCT01235975|B3|Baseline|Total|Total of all reporting groups
303842|NCT01235975|B2|Baseline|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
303843|NCT01235975|B1|Baseline|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
303844|NCT01235975|P2|Participant Flow|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
303845|NCT01235975|P1|Participant Flow|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
303846|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
303847|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
303848|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
303849|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
303850|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
303851|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
303852|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
303853|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
303854|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
303855|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
303856|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
303892|NCT01235897|P1|Participant Flow|MK-2206|MK-2206 : MK-2206 given orally at a dose of 135 mg weekly Trastuzumab : 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab Paclitaxel : 80 mg/m2 weekly - paclitaxel
303857|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
303858|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
303859|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
303860|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
303861|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
303862|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
303863|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
303864|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
303865|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
303866|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
303867|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
303868|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
303869|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
303870|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
303871|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
303872|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
303873|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
303874|NCT01235975|E2|Reported Event|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
303875|NCT01235975|E1|Reported Event|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
303876|NCT01235923|B3|Baseline|Total|Total of all reporting groups
303877|NCT01235923|B2|Baseline|Weekly Epo|Epo 1,200 units/kg given once a week subcutaneously for 4 weeks
303878|NCT01235923|B1|Baseline|Three Times Weekly Epo|Epo 400 units/kg three times weekly given subcutaneously for 4 weeks
303879|NCT01235923|P2|Participant Flow|Weekly Epo|Epo 1,200 units/kg given once a week subcutaneously for 4 weeks
303880|NCT01235923|P1|Participant Flow|Three Times Weekly Epo|Epo 400 units/kg three times weekly given subcutaneously for 4 weeks
303881|NCT01235923|O2|Outcome|Three Times a Week Epo|
303882|NCT01235923|O1|Outcome|Weekly Epo|
303883|NCT01235923|O2|Outcome|Three Times a Week Epo|
303884|NCT01235923|O1|Outcome|Weekly Epo|
303885|NCT01235923|E2|Reported Event|Three Times Weekly Epo|Epo 400 units/kg three times weekly given subcutaneously for 4 weeks
303886|NCT01235923|E1|Reported Event|Weekly Epo|Epo 1,200 units/kg given once a week subcutaneously for 4 weeks
303887|NCT01235910|B1|Baseline|Aliskiren|"Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows~Aliskiren: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows"
303888|NCT01235910|P1|Participant Flow|Aliskiren|"Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows~Aliskiren: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows"
303889|NCT01235910|O1|Outcome|Aliskiren|"Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows~Aliskiren: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows"
303890|NCT01235910|E1|Reported Event|Aliskiren|"Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows~Aliskiren: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows"
303891|NCT01235897|B1|Baseline|MK-2206|MK-2206 : MK-2206 given orally at a dose of 135 mg weekly Trastuzumab : 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab Paclitaxel : 80 mg/m2 weekly - paclitaxel
304400|NCT01234103|B3|Baseline|Total|Total of all reporting groups
303893|NCT01235897|O1|Outcome|MK-2206|MK-2206 given orally at a dose of 135 mg weekly + Trastuzumab 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg + Paclitaxel 80 mg/m2 weekly
303894|NCT01235897|O1|Outcome|MK-2206|MK-2206 : MK-2206 given orally at a dose of 135 mg weekly Trastuzumab : 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab Paclitaxel : 80 mg/m2 weekly - paclitaxel
303895|NCT01235897|E1|Reported Event|MK-2206|MK-2206 : MK-2206 given orally at a dose of 135 mg weekly Trastuzumab : 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab Paclitaxel : 80 mg/m2 weekly - paclitaxel
303896|NCT01235741|B4|Baseline|Total|Total of all reporting groups
303897|NCT01235741|B3|Baseline|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
303898|NCT01235741|B2|Baseline|Placebo|Self administered subcutaneous (SC ) injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) twice a day (BID) for 16 weeks.
303899|NCT01235741|B1|Baseline|Non-Randomized Lead-in LCD|6 Week Lead-in with low calorie diet (LCD); in the last week of the 6 week LCD, self administered subcutaneous (SC) injections of placebo once a day (QD) was initiated and then followed by randomization to study drug in the Randomization period.
303900|NCT01235741|P3|Participant Flow|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 micrograms (µg) + metreleptin 5.0 milligrams (mg) BID for 16 weeks
303901|NCT01235741|P2|Participant Flow|Placebo|Self administered subcutaneous (SC) injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) twice a day (BID) for 16 weeks.
303902|NCT01235741|P1|Participant Flow|Low Calorie Diet Only|6 Week Lead-in Period with low calorie diet (LCD); in the last week of the 6 week LCD, self administered subcutaneous (SC) injections of placebo once a day (QD) was initiated and then followed by randomization to either study drug or placebo in the Randomization period.
303903|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
303904|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
303905|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
303906|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks
303907|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
303908|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks
303909|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
303910|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
303911|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
303912|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
303913|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
303914|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
303915|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
303916|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
303917|NCT01235741|O1|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
303918|NCT01235741|O1|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
303919|NCT01235741|O1|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
303920|NCT01235741|O4|Outcome|Post Treatment Pramlintide + Metreleptin Arm|From date after the date of last dose (imputed if not available) of randomized study medication up to 6 Months post treatment.
303921|NCT01235741|O3|Outcome|Post Treatment Placebo Arm|From date after the date of last dose (imputed if not available) of randomized study medication up to 6 Months post treatment.
303922|NCT01235741|O2|Outcome|On Treatment Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
303923|NCT01235741|O1|Outcome|On Treatment Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
303924|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
303925|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
303926|NCT01235741|E2|Reported Event|Pramlintide + Metreleptin|Self administered subcutaneous injection once a day (QD) of pramlintide 360 micrograms (µg) plus metreleptin 5.0 milligrams (mg ) for 1 week followed by twice a week (BID) dosing for 15 weeks (Total of 16 Weeks treatment).
303927|NCT01235741|E1|Reported Event|Placebo-P + Placebo-M|Self administered subcutaneous injection once a day (QD) of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) for 1 week followed by BID dosing for 15 weeks (16 weeks total).
303928|NCT01235728|B1|Baseline|MK-0873|Participants were randomized to receive MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C. The lesion receiving calcitriol was evaluated.
303929|NCT01235728|P8|Participant Flow|Treatment Sequence 8|Participants were randomized to receive vehicle on lower lesion A and MK-0873 on lower lesion B, and calcitriol on upper lesion C and MK-0873 on upper lesion D.
303930|NCT01235728|P7|Participant Flow|Treatment Sequence 7|Participants were randomized to receive vehicle on upper lesion A and MK-0873 on upper lesion B, and calcitriol on lower lesion C and MK-0873 on lower lesion D.
303931|NCT01235728|P6|Participant Flow|Treatment Sequence 6|Participants were randomized to receive vehicle on lower lesion A and MK-0873 on lower lesion B, and MK-0873 on upper lesion C and calcitriol on upper lesion D.
303932|NCT01235728|P5|Participant Flow|Treatment Sequence 5|Participants were randomized to receive vehicle on upper lesion A and MK-0873 on upper lesion B, and MK-0873 on lower lesion C and calcitriol on lower lesion D.
303933|NCT01235728|P4|Participant Flow|Treatment Sequence 4|Participants were randomized to receive MK-0873 on lower lesion A and vehicle on lower lesion B, and calcitriol on upper lesion C and MK-873 on upper lesion D.
303934|NCT01235728|P3|Participant Flow|Treatment Sequence 3|Participants were randomized to receive MK-0873 on upper lesion A and vehicle on upper lesion B, and calcitriol on lower lesion C and MK-0873 on lower lesion D.
303935|NCT01235728|P2|Participant Flow|Treatment Sequence 2|Participants were randomized to receive MK-0873 on lower lesion A and vehicle on lower lesion B, and MK-0873 on upper lesion C and calcitriol on upper lesion D.
303936|NCT01235728|P1|Participant Flow|Treatment Sequence 1|Participants were randomized to receive MK-0873 on upper lesion A and vehicle on upper lesion B, and MK-0873 on lower lesion C and calcitriol on lower lesion D.
303937|NCT01235728|O1|Outcome|MK-0873|Participants were randomized to receive MK- 0873 on upper or lower lesion A or B and MK-0873 Vehicle on the opposing lesion B or A, and MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C.
303938|NCT01235728|O2|Outcome|MK-0873|Participants were randomized to receive MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C. The lesion receiving MK-0873 was evaluated.
303939|NCT01235728|O1|Outcome|Calcitriol 0.0003%|Participants were randomly assigned to receive calcitriol 0.0003% (3mg/g) BID for 28 days on upper or lower lesion C or D and MK-0873 on the opposing lesion D or C. The lesion receiving calcitriol was evaluated.
303940|NCT01235728|O2|Outcome|MK-0873 Vehicle|Participants were randomized to receive MK-0873 vehicle on upper or lower lesion A or B and MK-0873 on the opposing lesion B or A. The lesion receiving MK-0873 vehicle was evaluated.
303941|NCT01235728|O1|Outcome|MK-0873|Participants were randomized to receive MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C. The lesion receiving MK-0873 was evaluated.
303942|NCT01235728|E1|Reported Event|MK-0873|Participants were randomized to receive MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C. The lesion receiving calcitriol was evaluated.
303943|NCT01235715|B3|Baseline|Total|Total of all reporting groups
303944|NCT01235715|B2|Baseline|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
303945|NCT01235715|B1|Baseline|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
303946|NCT01235715|P2|Participant Flow|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
303947|NCT01235715|P1|Participant Flow|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
303948|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
303949|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
303950|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
303951|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
303952|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
303953|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
303954|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
303955|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
303956|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
303957|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
303958|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
304104|NCT01235546|B2|Baseline|Azithromycin (Zithromax) With Standard Prophylaxis|Azithromycin: 500 mg in 250 cc normal saline 1 time dose Standard Prophylaxis: standard cephalosporin prophylaxis
303959|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
303960|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
303961|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
303962|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
303963|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
303964|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
303965|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
303966|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
303967|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
303968|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
303969|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
303970|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
303971|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
303972|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
303973|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
303974|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
303975|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
303976|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
303977|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
303978|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
303979|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
303980|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
303981|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
303982|NCT01235715|E2|Reported Event|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
303983|NCT01235715|E1|Reported Event|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
303984|NCT01235689|B3|Baseline|Total|Total of all reporting groups
304411|NCT01233999|B1|Baseline|Botox|single-drug dosage comparison cross-over study
303985|NCT01235689|B2|Baseline|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
303986|NCT01235689|B1|Baseline|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
303987|NCT01235689|P2|Participant Flow|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine. Participants who randomized at Week 9 meeting success criteria started with no therapy; participants who randomized prior to Week 9 or who randomized at Week 9 but did not meet the success criteria began treatment with adalimumab.~Therapy was escalated according to pre-specified tight control criteria: At Key Visit 1 the success criteria were CDAI < 150, hs-CRP, < 5 mg/L, fecal calprotectin < 250 μg/g, and absence of prednisone use. At Key Visits 3, 4, and 5 (every 12 weeks after Key visit 1), the criteria were CDAI < 150, hs-CRP < 5 mg/L, fecal calprotectin < 250 μg/g, and absence of prednisone during the preceding week."
303988|NCT01235689|P1|Participant Flow|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine.~Participants who randomized at Week 9 meeting success criteria started with no therapy; participants who randomized prior to Week 9 or who randomized at Week 9 but did not meet the success criteria began treatment with adalimumab.~Therapy was escalated according to pre-specified failure criteria using less stringent criteria:~At Key Visit 1 the criteria for management of disease activity were a CDAI decrease ≥ 70 (CR-70) compared to Baseline or CDAI < 200 at 1 week prior to the visit. At Key Visits 3, 4, and 5 (every 12 weeks after Key visit 1), the criteria for a change in treatment were a CDAI decrease of ≥ 100 (CR-100) compared to Baseline or CDAI < 200, and absence of prednisone during the preceding week."
303989|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
303990|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
303991|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
303992|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
303993|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
303994|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
303995|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
303996|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
303997|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
303998|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
303999|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304000|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304001|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304002|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304003|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304004|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304005|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304006|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304007|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304008|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304009|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304010|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304011|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304012|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304013|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304014|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304015|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304016|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304017|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304018|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304019|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304020|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304021|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304022|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304023|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304105|NCT01235546|B1|Baseline|Placebo With Standard Prophylaxis|Placebo: 250 cc normal saline Standard Prophylaxis: standard cephalosporin prophylaxis
304024|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304025|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304026|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304027|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304028|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304029|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304030|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304031|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304032|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304033|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304034|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304035|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304036|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304037|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304038|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304039|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304040|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304041|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304042|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304043|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304044|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304106|NCT01235546|P2|Participant Flow|Azithromycin and Standard of Care|Azithromycin: 500 mg in 250 cc normal saline 1 time dose and standard of care (cephazolin or clindamycin)
304045|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304046|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304047|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304048|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304049|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304050|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304051|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304052|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304053|NCT01235689|O2|Outcome|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304054|NCT01235689|O1|Outcome|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304055|NCT01235689|E2|Reported Event|Tight Control Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304056|NCT01235689|E1|Reported Event|Clinically Driven Management|"Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use.~Participants received customized therapy that could include prednisone, adalimumab, and azathioprine."
304057|NCT01235598|B3|Baseline|Total|Total of all reporting groups
304058|NCT01235598|B2|Baseline|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304059|NCT01235598|B1|Baseline|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
304060|NCT01235598|P2|Participant Flow|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304061|NCT01235598|P1|Participant Flow|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
304062|NCT01235598|O2|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304063|NCT01235598|O1|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
304064|NCT01235598|O2|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304065|NCT01235598|O1|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
304066|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304067|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304068|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304069|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304070|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304071|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304072|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
304073|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304074|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
304075|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304076|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
304077|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304078|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
304079|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304080|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
304081|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304082|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
304083|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304084|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
304085|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304086|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
304087|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304088|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
304089|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304090|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
304091|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304092|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
304093|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304094|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304095|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304096|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304097|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304098|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304099|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304100|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304101|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
304102|NCT01235598|E1|Reported Event|Certolizumab Pegol (CZP) at Any Time|"Eligible subjects were allocated to the following study treatments in a 2:1 ratio:~Certolizumab Pegol (CZP) 400mg for subcutaneous injection (sc) at Weeks 0, 2, and 4, followed by CZP 200mg sc and placebo (saline solution) at Week 6 and CZP 200mg at Weeks 8, 10, 12, 14, and 16 or~Placebo (saline solution) at Day 0 and then CZP 400mg sc at Weeks 2, 4, and 6 followed by CZP 200mg sc at Weeks 8, 10, 12, 14, and 16"
304103|NCT01235546|B3|Baseline|Total|Total of all reporting groups
304107|NCT01235546|P1|Participant Flow|Placebo and Standard of Care|Placebo: 250 cc normal saline Standard of care (cephazolin or clindamycin)
304108|NCT01235546|O2|Outcome|Azithromycin and Standard of Care|Azithromycin: 500 mg in 250 cc normal saline 1 time dose and Standard of care (cefazolin or clindamycin)
304109|NCT01235546|O1|Outcome|Placebo and Standard of Care|Placebo: 250 cc normal saline and Standard of care (cefazolin or clindamycin)
304110|NCT01235546|O2|Outcome|Azithromycin and Standard of Care|Azithromycin: 500 mg in 250 cc normal saline 1 time dose and Standard of care (cefazolin or clindamycin)
304111|NCT01235546|O1|Outcome|Placebo and Standard of Care|Placebo: 250 cc normal saline and Standard of care (cefazolin or clindamycin)
304112|NCT01235546|O2|Outcome|Azithromycin and Standard of Care|Azithromycin: 500 mg in 250 cc normal saline 1 time dose and Standard of care (cefazolin or clindamycin)
304113|NCT01235546|O1|Outcome|Placebo and Standard of Care|Placebo: 250 cc normal saline and Standard of care (cefazolin or clindamycin)
304114|NCT01235546|O2|Outcome|Azithromycin and Standard of Care|Azithromycin: 500 mg in 250 cc normal saline 1 time dose and Standard of care (cefazolin or clindamycin)
304115|NCT01235546|O1|Outcome|Placebo and Standard of Care|Placebo: 250 cc normal saline and Standard of care (cefazolin or clindamycin)
304116|NCT01235546|O2|Outcome|Azithromycin and Standard of Care|Azithromycin: 500 mg in 250 cc normal saline 1 time dose Standard of care (cefazolin or clindamycin)
304117|NCT01235546|O1|Outcome|Placebo and Standard of Care|Placebo: 250 cc normal saline Standard of care (cefazolin or clindamycin)
304118|NCT01235546|O2|Outcome|Azithromycin (Zithromax) With Standard Prophylaxis|Azithromycin: 500 mg in 250 cc normal saline 1 time dose Standard Prophylaxis: standard cephalosporin prophylaxis
304119|NCT01235546|O1|Outcome|Placebo With Standard Prophylaxis|Placebo: 250 cc normal saline Standard Prophylaxis: standard cephalosporin prophylaxis
304120|NCT01235546|O2|Outcome|Azithromycin (Zithromax) With Standard Prophylaxis|Azithromycin: 500 mg in 250 cc normal saline 1 time dose Standard Prophylaxis: standard cephalosporin prophylaxis
304121|NCT01235546|O1|Outcome|Placebo With Standard Prophylaxis|Placebo: 250 cc normal saline Standard Prophylaxis: standard cephalosporin prophylaxis
304122|NCT01235546|O2|Outcome|Azithromycin and Standard of Care|Azithromycin: 500 mg in 250 cc normal saline 1 time dose and Standard of care (cefazolin or clindamycin)
304123|NCT01235546|O1|Outcome|Placebo and Standard of Care|"250 cc normal saline~Placebo: 250 cc normal saline and Standard of care (cefazolin or clindamycin)"
304124|NCT01235546|O2|Outcome|Azithromycin and Standard of Care|Azithromycin: 500 mg in 250 cc normal saline 1 time dose and Standard of Care (cefazolin or clindamycin
304125|NCT01235546|O1|Outcome|Placebo and Standard of Care|Placebo: 250 cc normal saline and standard of care (cefazolin or clindamycin)
304126|NCT01235546|O2|Outcome|Azithromycin|Azithromycin: 500 mg in 250 cc normal saline 1 time dose
304127|NCT01235546|O1|Outcome|Placebo|"250 cc normal saline~Placebo: 250 cc normal saline"
304128|NCT01235546|E2|Reported Event|Azithromycin and Standard of Care|Azithromycin: 500 mg in 250 cc normal saline and Standard of care (cefazolin or clindamycin)
304129|NCT01235546|E1|Reported Event|Placebo and Standard of Care|Placebo: 250 cc normal saline and Standard of care (cefazolin or clindamycin)
304130|NCT01235507|B1|Baseline|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
304131|NCT01235507|P1|Participant Flow|Tocilizumab Plus Methotrexate (MTX)|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (maximum 800 mg) intravenously (IV) every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg per week (mg/week) of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
304132|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
304133|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
304134|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
304135|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
304136|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
304137|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
304246|NCT01235195|O1|Outcome|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
304247|NCT01235195|O2|Outcome|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
304138|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
304139|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
304140|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
304141|NCT01235507|E1|Reported Event|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
304142|NCT01235442|B3|Baseline|Total|Total of all reporting groups
304143|NCT01235442|B2|Baseline|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
304144|NCT01235442|B1|Baseline|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
304145|NCT01235442|P2|Participant Flow|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
304146|NCT01235442|P1|Participant Flow|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
304147|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
304148|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
304149|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
304150|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
304151|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
304152|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
304153|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
304154|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
304155|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
304156|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
304157|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
304158|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
304159|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
304160|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
304161|NCT01235442|E2|Reported Event|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
304162|NCT01235442|E1|Reported Event|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
304716|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
304163|NCT01235403|B1|Baseline|Lacosamide|"Flexible dosing between 200mg/day and 400mg/day~Lacosamide: 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.~Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.~Taper phase if needed: 3 to 4 weeks"
304164|NCT01235403|P1|Participant Flow|Lacosamide|"Flexible dosing between 200 mg/day and 400 mg/day~Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.~Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.~Taper phase if needed: 3 to 4 weeks"
304165|NCT01235403|O1|Outcome|Lacosamide|"Flexible dosing between 200 mg/day and 400 mg/day~Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.~Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.~Taper phase if needed: 3 to 4 weeks"
304166|NCT01235403|O1|Outcome|Lacosamide|"Flexible dosing between 200 mg/day and 400 mg/day~Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.~Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.~Taper phase if needed: 3 to 4 weeks"
304167|NCT01235403|O1|Outcome|Lacosamide|"Flexible dosing between 200 mg/day and 400 mg/day~Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.~Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.~Taper phase if needed: 3 to 4 weeks"
304168|NCT01235403|E1|Reported Event|Lacosamide|"Flexible dosing between 200mg/day and 400mg/day~Lacosamide: 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.~Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.~Taper phase if needed: 3 to 4 weeks"
304169|NCT01235377|B3|Baseline|Total|Total of all reporting groups
304170|NCT01235377|B2|Baseline|Favor Hydrochlorothiazide|Providers randomized to Favor Hydrochlorothiazide agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
304171|NCT01235377|B1|Baseline|Favor Chlorthalidone|Providers randomized to Favor Chlorthalidone agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
304172|NCT01235377|P2|Participant Flow|Favor Hydrochlorothiazide|Providers randomized to Favor Hydrochlorothiazide agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
304173|NCT01235377|P1|Participant Flow|Favor Chlorthalidone|Providers randomized to Favor Chlorthalidone agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
304174|NCT01235377|O2|Outcome|Favor Hydrochlorothiazide|Providers randomized to Favor Hydrochlorothiazide agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
304175|NCT01235377|O1|Outcome|Favor Chlorthalidone|Providers randomized to Favor Chlorthalidone agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
304176|NCT01235377|E2|Reported Event|Favor Hydrochlorothiazide|Providers randomized to Favor Hydrochlorothiazide agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
304177|NCT01235377|E1|Reported Event|Favor Chlorthalidone|Providers randomized to Favor Chlorthalidone agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
304178|NCT01235338|B3|Baseline|Total|Total of all reporting groups
304179|NCT01235338|B2|Baseline|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304180|NCT01235338|B1|Baseline|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304181|NCT01235338|P2|Participant Flow|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304717|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
304182|NCT01235338|P1|Participant Flow|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304183|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304184|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304185|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304186|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304187|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304188|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304189|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304190|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304191|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304192|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304193|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304194|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304195|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304196|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304197|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304198|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304199|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304200|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304201|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304202|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304203|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304204|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304205|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304206|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304207|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304208|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304209|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304210|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304248|NCT01235195|O1|Outcome|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
304249|NCT01235195|O2|Outcome|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
304250|NCT01235195|O1|Outcome|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
304211|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304212|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304213|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304214|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304215|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304216|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304217|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304218|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
304219|NCT01235338|E4|Reported Event|Venlafaxine XR Tapering|Tapering dosing period (Effexor XR 150 and 75 mg)
304220|NCT01235338|E3|Reported Event|Venlafaxine XR Titration|Titration dosing period (Effexor XR 75, 150, and 225 mg)
304221|NCT01235338|E2|Reported Event|LDX + Venlafaxine XR/Venlafaxine XR + LDX|Combination dosing periods
304222|NCT01235338|E1|Reported Event|LDX (SPD489)|Titration dosing period
304223|NCT01235234|B4|Baseline|Total|Total of all reporting groups
304224|NCT01235234|B3|Baseline|Placebo|CF101: orally q12h
304225|NCT01235234|B2|Baseline|CF101 1 mg|CF101: orally q12h
304226|NCT01235234|B1|Baseline|CF101 0.1 mg|CF101: orally q12h
304227|NCT01235234|P3|Participant Flow|Placebo|CF101: orally q12h
304228|NCT01235234|P2|Participant Flow|CF101 1 mg|CF101: orally q12h
304229|NCT01235234|P1|Participant Flow|CF101 0.1 mg|CF101: orally q12h
304230|NCT01235234|O3|Outcome|Placebo|CF101: orally q12h
304231|NCT01235234|O2|Outcome|CF101 1 mg|CF101: orally q12h
304232|NCT01235234|O1|Outcome|CF101 0.1 mg|CF101: orally q12h
304233|NCT01235234|E3|Reported Event|Placebo|CF101: orally q12h
304234|NCT01235234|E2|Reported Event|CF101 1 mg|CF101: orally q12h
304235|NCT01235234|E1|Reported Event|CF101 0.1 mg|CF101: orally q12h
304236|NCT01235195|B1|Baseline|Entire Study Population|Entire study population receiving Sertraline Hydrochloride 50 mg as either hard gelatin capsule or film-coated tablet
304237|NCT01235195|P2|Participant Flow|Sertraline 50 mg Tablet, Then Sertraline 50 mg Capsule|Sertraline Hydrochloride 50 mg film-coated tablet in the first intervention period, Sertraline Hydrochloride 50 mg hard gelatin capsule in the second intervention period
304238|NCT01235195|P1|Participant Flow|Sertraline 50 mg Capsule, Then Sertraline 50 mg Tablet|Sertraline Hydrochloride 50 milligram (mg) hard gelatin capsule in the first intervention period, Sertraline Hydrochloride 50 mg Film-Coated Tablet in the second intervention period
304239|NCT01235195|O2|Outcome|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
304240|NCT01235195|O1|Outcome|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
304241|NCT01235195|O2|Outcome|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
304242|NCT01235195|O1|Outcome|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
304243|NCT01235195|O2|Outcome|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
304244|NCT01235195|O1|Outcome|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
304245|NCT01235195|O2|Outcome|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
304251|NCT01235195|E2|Reported Event|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
304252|NCT01235195|E1|Reported Event|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
304253|NCT01234922|B5|Baseline|Total|Total of all reporting groups
304254|NCT01234922|B4|Baseline|Arm IV|"Patients receive oral losartan potassium once daily on days 1-7.~losartan potassium: Given orally~laboratory biomarker analysis: Correlative studies"
304255|NCT01234922|B3|Baseline|Arm III|"Patients receive oral ramipril twice daily on days 1-7.~laboratory biomarker analysis: Correlative studies~ramipril: Given orally"
304256|NCT01234922|B2|Baseline|Arm II|"Patients receive oral lisinopril once daily on days 1-7.~lisinopril: Given orally~laboratory biomarker analysis: Correlative studies"
304257|NCT01234922|B1|Baseline|Arm I|"Patients receive oral benazepril hydrochloride once daily on days 1-7.~laboratory biomarker analysis: Correlative studies~benazepril hydrochloride: Given orally"
304258|NCT01234922|P4|Participant Flow|Arm IV|"Patients receive oral losartan potassium once daily on days 1-7.~losartan potassium: Given orally~laboratory biomarker analysis: Correlative studies"
304259|NCT01234922|P3|Participant Flow|Arm III|"Patients receive oral ramipril twice daily on days 1-7.~laboratory biomarker analysis: Correlative studies~ramipril: Given orally"
304260|NCT01234922|P2|Participant Flow|Arm II|"Patients receive oral lisinopril once daily on days 1-7.~lisinopril: Given orally~laboratory biomarker analysis: Correlative studies"
304261|NCT01234922|P1|Participant Flow|Arm I|"Patients receive oral benazepril hydrochloride once daily on days 1-7.~laboratory biomarker analysis: Correlative studies~benazepril hydrochloride: Given orally"
304262|NCT01234922|O4|Outcome|Arm IV|"Patients receive oral losartan potassium once daily on days 1-7.~losartan potassium: Given orally~laboratory biomarker analysis: Correlative studies"
304263|NCT01234922|O3|Outcome|Arm III|"Patients receive oral ramipril twice daily on days 1-7.~laboratory biomarker analysis: Correlative studies~ramipril: Given orally"
304264|NCT01234922|O2|Outcome|Arm II|"Patients receive oral lisinopril once daily on days 1-7.~lisinopril: Given orally~laboratory biomarker analysis: Correlative studies"
304265|NCT01234922|O1|Outcome|Arm I|"Patients receive oral benazepril hydrochloride once daily on days 1-7.~laboratory biomarker analysis: Correlative studies~benazepril hydrochloride: Given orally"
304266|NCT01234922|O4|Outcome|Arm IV|"Patients receive oral losartan potassium once daily on days 1-7.~losartan potassium: Given orally~laboratory biomarker analysis: Correlative studies"
304267|NCT01234922|O3|Outcome|Arm III|"Patients receive oral ramipril twice daily on days 1-7.~laboratory biomarker analysis: Correlative studies~ramipril: Given orally"
304268|NCT01234922|O2|Outcome|Arm II|"Patients receive oral lisinopril once daily on days 1-7.~lisinopril: Given orally~laboratory biomarker analysis: Correlative studies"
304269|NCT01234922|O1|Outcome|Arm I|"Patients receive oral benazepril hydrochloride once daily on days 1-7.~laboratory biomarker analysis: Correlative studies~benazepril hydrochloride: Given orally"
304270|NCT01234922|E4|Reported Event|Arm IV|"Patients receive oral losartan potassium once daily on days 1-7.~losartan potassium: Given orally~laboratory biomarker analysis: Correlative studies"
304271|NCT01234922|E3|Reported Event|Arm III|"Patients receive oral ramipril twice daily on days 1-7.~laboratory biomarker analysis: Correlative studies~ramipril: Given orally"
304272|NCT01234922|E2|Reported Event|Arm II|"Patients receive oral lisinopril once daily on days 1-7.~lisinopril: Given orally~laboratory biomarker analysis: Correlative studies"
304273|NCT01234922|E1|Reported Event|Arm I|"Patients receive oral benazepril hydrochloride once daily on days 1-7.~laboratory biomarker analysis: Correlative studies~benazepril hydrochloride: Given orally"
304274|NCT01234883|B3|Baseline|Total|Total of all reporting groups
304275|NCT01234883|B2|Baseline|0.9% Saline|saline: IV saline solution dosed as clinically indicated for rehydration
304276|NCT01234883|B1|Baseline|Plasma-Lyte A|multiple electrolyte solution: IV multiple electrolyte solution dosed as clinically indicated for rehydration
304277|NCT01234883|P2|Participant Flow|Saline|0.9% Normal Saline: IV saline solution dosed as clinically indicated for rehydration
304278|NCT01234883|P1|Participant Flow|Multiple Electrolyte Solution|Plasma Lyte A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP): IV multiple electrolyte solution dosed as clinically indicated for rehydration.
304279|NCT01234883|O2|Outcome|Saline|saline: IV saline solution dosed as clinically indicated for rehydration
304280|NCT01234883|O1|Outcome|Multiple Electrolyte Solution|multiple electrolyte solution: IV multiple electrolyte solution dosed as clinically indicated for rehydration
304281|NCT01234883|E2|Reported Event|Saline|saline: IV saline solution dosed as clinically indicated for rehydration
304282|NCT01234883|E1|Reported Event|Multiple Electrolyte Solution|multiple electrolyte solution: IV multiple electrolyte solution dosed as clinically indicated for rehydration
304283|NCT01234870|B1|Baseline|Adenosine|"Adenosine (Adenoscan) will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins.~adenosine: Adenosine will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins"
304284|NCT01234870|P1|Participant Flow|Ischemic Heart Disease Patients|Patients with suspected ischemic heart disease prospectively recruited for first pass myocardial perfusion MRI. All subject to receive Gadolinium infusion of 0.075 mmol/kg at rate of 4 ml/sec. Adenosine administered at a rate of 0.14 mg/kg/min for a duration of 4 minutes to induce stress.
304285|NCT01234870|O1|Outcome|Adenosine|"Adenosine (Adenoscan) will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins.~adenosine: Adenosine will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins"
304286|NCT01234870|O1|Outcome|Ischemic Heart Disease Patients|Patients with suspected ischemic heart disease prospectively recruited for first pass myocardial perfusion MRI. All subject to receive Gadolinium infusion of 0.075 mmol/kg at rate of 4 ml/sec. Adenosine administered at a rate of 0.14 mg/kg/min for a duration of 4 minutes to induce stress.
304287|NCT01234870|E1|Reported Event|Adenosine|"Adenosine (Adenoscan) will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins.~adenosine: Adenosine will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins"
304288|NCT01234831|B3|Baseline|Total|Total of all reporting groups
304390|NCT01234207|O2|Outcome|Test Spectacles|"Arm/Groups Outcome Measures are reported per intervention."
304289|NCT01234831|B2|Baseline|Passive Screening|Patients randomized to passive screening will not actively be identified for testing but may be tested using culture-based algorithm by care team.
304290|NCT01234831|B1|Baseline|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
304291|NCT01234831|P2|Participant Flow|Passive Screening|Patients randomized to passive screening will not actively be identified for testing but may be tested using culture-based algorithm by care team.
304292|NCT01234831|P1|Participant Flow|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
304293|NCT01234831|O1|Outcome|Active Screening With Contact Precautions Removed|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays. Contact Precautions will be removed for subjects who are cleared of colonization based on the study intervention.
304294|NCT01234831|O1|Outcome|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
304295|NCT01234831|O1|Outcome|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
304296|NCT01234831|O1|Outcome|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
304297|NCT01234831|O2|Outcome|Passive Screening|Patients randomized to the Passive Screening arm will not actively be identified for testing but may be tested using institutional culture-based protocol available to all primary care teams.
304298|NCT01234831|O1|Outcome|Active Screening|Patients randomized to the Active Screening arm will have paired nasal swabs collected daily for 3 days; one processed using nucleic acid amplification and the other using culture (CHROMagar) assays.
304299|NCT01234831|O2|Outcome|Passive Screening|Patients randomized to the Passive Screening arm will not actively be identified for testing but may be tested using institutional culture-based protocol available to all primary care teams.
304300|NCT01234831|O1|Outcome|Active Screening|Patients randomized to the Active Screening arm will have paired nasal swabs collected daily for 3 days; one processed using nucleic acid amplification and the other using culture (CHROMagar) assays.
304301|NCT01234831|O1|Outcome|Active Screening|Patients randomized to the Active Screening arm will have paired nasal swabs collected daily for 3 days; one processed using nucleic acid amplification and the other using culture (CHROMagar) assays.
304302|NCT01234831|E1|Reported Event|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
304303|NCT01234766|B1|Baseline|Single Arm|"Subjects will receive bendamustine and rituximab, followed by 90-yttrium (Y) Ibritumomab Tiuxetan~Bendamustine: 90mg/m2, IV - Days 1 and 2 of every cycle~Rituximab: 375mg/m2, IV - Cycle 1 only: Day -7 (+1 day) Day 1 of every cycle~Y-90 ibritumomab: 0.4mCi/kg, IV - Within 4 hours of rituximab, give over 10 minutes"
304304|NCT01234766|P1|Participant Flow|Single Arm|"Subjects will receive bendamustine and rituximab, followed by 90-yttrium (Y) Ibritumomab Tiuxetan~Bendamustine: 90mg/m2, IV - Days 1 and 2 of every cycle~Rituximab: 375mg/m2, IV - Cycle 1 only: Day -7 (+1 day) Day 1 of every cycle~Y-90 ibritumomab: 0.4mCi/kg, IV - Within 4 hours of rituximab, give over 10 minutes"
304305|NCT01234766|O1|Outcome|Single Arm|"Subjects will receive bendamustine and rituximab, followed by 90-yttrium (Y) Ibritumomab Tiuxetan~Bendamustine: 90mg/m2, IV - Days 1 and 2 of every cycle~Rituximab: 375mg/m2, IV - Cycle 1 only: Day -7 (+1 day) Day 1 of every cycle~Y-90 ibritumomab: 0.4mCi/kg, IV - Within 4 hours of rituximab, give over 10 minutes"
304306|NCT01234766|E1|Reported Event|Single Arm|"Subjects will receive bendamustine and rituximab, followed by 90-yttrium (Y) Ibritumomab Tiuxetan~Bendamustine: 90mg/m2, IV - Days 1 and 2 of every cycle~Rituximab: 375mg/m2, IV - Cycle 1 only: Day -7 (+1 day) Day 1 of every cycle~Y-90 ibritumomab: 0.4mCi/kg, IV - Within 4 hours of rituximab, give over 10 minutes"
304307|NCT01234714|B1|Baseline|Major Liver Resection|This single Cohort/Group will include all consecutive patients that received pre-operative Magnetic Resonant Imaging (MRI) and underwent major liver resection (>=3 segments).
304308|NCT01234714|P1|Participant Flow|Major Liver Resection|This single Cohort/Group will include all consecutive patients that received pre-operative Magnetic Resonant Imaging (MRI) and underwent major liver resection (>=3 segments).
304309|NCT01234714|O2|Outcome|Patient Group With Liver Fat Content >10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
304310|NCT01234714|O1|Outcome|Patient Group With Liver Fat Content <10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
304311|NCT01234714|O2|Outcome|Patient Group With Liver Fat Content >10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
304312|NCT01234714|O1|Outcome|Patient Group With Liver Fat Content <10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
304313|NCT01234714|O2|Outcome|Patient Group With Liver Fat Content >10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
304314|NCT01234714|O1|Outcome|Patient Group With Liver Fat Content <10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
304315|NCT01234714|O2|Outcome|Patient Group With Liver Fat Content >10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
304316|NCT01234714|O1|Outcome|Patient Group With Liver Fat Content <10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
304317|NCT01234714|O2|Outcome|Patient Group With Liver Fat Content >10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
304318|NCT01234714|O1|Outcome|Patient Group With Liver Fat Content <10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
304319|NCT01234714|O2|Outcome|Patient Group With Liver Fat Content >10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
304718|NCT01233232|O2|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
304320|NCT01234714|O1|Outcome|Patient Group With Liver Fat Content <10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
304321|NCT01234714|O2|Outcome|Clavien-Dindo Grade ≥IV Complications|"Percentage of liver fat content on MRI in patients with Clavien-Dindo Grade <IV complications.~These are typically life-threatening complication (including CNS complications) requiring ICU management.~Grade IVa: single organ dysfunction (including dialysis)~Grade IVb: multi-organ dysfunction"
304322|NCT01234714|O1|Outcome|Clavien-Dindo Grade <IV Complications|"Percentage of liver fat content on MRI in patients with Clavien-Dindo Grade <IV complications.~No complications: Patients without any post-operative complications defined according to the Clavien-Dindo Classification.~Grade 1: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside.~Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications.~Blood transfusions and total parenteral nutrition are also included.~Grade III:Requiring surgical, endoscopic or radiological intervention"
304323|NCT01234714|E1|Reported Event|Major Liver Resection|This single Cohort/Group will include all consecutive patients that received pre-operative Magnetic Resonant Imaging (MRI) and underwent major liver resection (>=3 segments).
304324|NCT01234675|B1|Baseline|All Study Participants|2 treatment period, with each period 6 weeks and 7 day washout period Milnacipran in treatment period 1, Placebo in treatment period 2 Placebo treatment in Period 1, and Milnacipran in Period 2
304325|NCT01234675|P2|Participant Flow|Milnacipran Then Placebo|50 mg BiD maintenance dose
304326|NCT01234675|P1|Participant Flow|Placebo Then Milnacipran|50 mg BiD maintenance dose
304327|NCT01234675|O2|Outcome|Placebo|50 mg placebo BiD
304328|NCT01234675|O1|Outcome|Milnacipran|Treatment with 50 mg BiD
304329|NCT01234675|O2|Outcome|Placebo|50 mg placebo BiD
304330|NCT01234675|O1|Outcome|Milnacipran|Treatment with 50 mg BiD
304331|NCT01234675|O2|Outcome|Placebo|50 mg placebo BiD
304332|NCT01234675|O1|Outcome|Milnacipran|Treatment with 50 mg BiD
304333|NCT01234675|O2|Outcome|Placebo|50 mg placebo BiD
304334|NCT01234675|O1|Outcome|Milnacipran|Treatment with 50 mg BiD
304335|NCT01234675|O2|Outcome|Placebo|50 mg placebo BiD
304336|NCT01234675|O1|Outcome|Milnacipran|Treatment with 50 mg BiD
304337|NCT01234675|E2|Reported Event|Placebo|Drug: Placebo 50 mg, twice daily for 4 weeks.
304338|NCT01234675|E1|Reported Event|Milnacipran|Drug: milnacipran, 50 mg twice daily for 4 weeks.
304339|NCT01234467|B1|Baseline|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.~Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles~Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
304340|NCT01234467|P1|Participant Flow|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.~Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles~Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
304341|NCT01234467|O1|Outcome|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.~Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles~Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
304342|NCT01234467|O1|Outcome|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.~Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles~Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
304343|NCT01234467|O1|Outcome|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.~Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles~Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
304391|NCT01234207|O1|Outcome|Control Spectacles|"Arm/Groups Outcome Measures are reported per intervention."
304392|NCT01234207|O2|Outcome|Test Spectacles|"Arm/Groups Outcome Measures are reported per intervention."
304393|NCT01234207|O1|Outcome|Control Spectacles|"Arm/Groups Outcome Measures are reported per intervention."
304344|NCT01234467|O1|Outcome|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.~Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles~Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
304345|NCT01234467|O1|Outcome|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.~Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles~Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
304346|NCT01234467|O1|Outcome|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.~Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles~Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
304347|NCT01234467|E1|Reported Event|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.~Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles~Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
304348|NCT01234337|B3|Baseline|Total|Total of all reporting groups
304349|NCT01234337|B2|Baseline|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
304350|NCT01234337|B1|Baseline|Sorafenib(Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 milligram per square meter (mg/m^2) twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
304351|NCT01234337|P2|Participant Flow|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
304352|NCT01234337|P1|Participant Flow|Sorafenib(Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 milligram per square meter (mg/m^2) twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
304353|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
304354|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
304355|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
304394|NCT01234207|O2|Outcome|Test Spectacles|"Arm/Groups Outcome Measures are reported per intervention."
304356|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
304357|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
304358|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
304359|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
304360|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
304361|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
304362|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
304363|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
304364|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
304365|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
304366|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
304367|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
304368|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
304369|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
304370|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
304371|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
304372|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
304373|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
304374|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
304375|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
304376|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
304377|NCT01234337|E2|Reported Event|Sorafenib(Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 milligram per square meter (mg/m^2) twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
304378|NCT01234337|E1|Reported Event|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
304379|NCT01234207|B1|Baseline|All Study Participants|Crossover trial: all study participants received both Test and Control spectacles, in randomized order.
304380|NCT01234207|P2|Participant Flow|Group 2 - Test Spectacles Worn First, Then Control Spectacles|Crossover trial; 2 arms: subjects randomized to wear Test spectacles 1st, then Control spectacles 2nd
304381|NCT01234207|P1|Participant Flow|Group 1 - Control Spectacles Worn First, Then Test Spectacles|Crossover trial; 2 arms: subjects randomized to wear Control spectacles 1st, then Test spectacles 2nd
304382|NCT01234207|O2|Outcome|Test Spectacles|"Arm/Groups Outcome Measures are reported per intervention"
304383|NCT01234207|O1|Outcome|Control Spectacles|"Arm/Groups Outcome Measures are reported per intervention"
304384|NCT01234207|O2|Outcome|Test Spectacles|"Arm/Groups Outcome Measures are reported per intervention"
304385|NCT01234207|O1|Outcome|Control Spectacles|"Arm/Groups Outcome Measures are reported per intervention"
304386|NCT01234207|O2|Outcome|Test Spectacles|"Arm/Groups Outcome Measures are reported per intervention"
304387|NCT01234207|O1|Outcome|Control Spectacles|"Arm/Groups Outcome Measures are reported per intervention"
304388|NCT01234207|O2|Outcome|Test Spectacles|"Arm/Groups Outcome Measures are reported per intervention"
304389|NCT01234207|O1|Outcome|Control Spectacles|"Arm/Groups Outcome Measures are reported per intervention"
304401|NCT01234103|B2|Baseline|Improving Nutrition, Fitness and Injury Prevention|"The goals are: (1) maintain and improve nutrition and physical fitness through healthier lifestyle and food choices; (2) reduce the risk of sports or physical training injuries and learning how to treat injuries; and (3) Learn to recognize stress and the steps you can take to reduce stress~Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
304402|NCT01234103|B1|Baseline|Preventing Sexual Health Risks|"The over goal is to prevent STIs, unintended pregnancies, and related behaviors including sexual risk, alcohol and other substance misuse~Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
304403|NCT01234103|P2|Participant Flow|Improving Nutrition, Fitness and Injury Prevention|"The goals are: (1) maintain and improve nutrition and physical fitness through healthier lifestyle and food choices; (2) reduce the risk of sports or physical training injuries and learning how to treat injuries; and (3) Learn to recognize stress and the steps you can take to reduce stress~Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
304404|NCT01234103|P1|Participant Flow|Preventing Sexual Health Risks|"The over goal is to prevent STIs, unintended pregnancies, and related behaviors including sexual risk, alcohol and other substance misuse~Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
304405|NCT01234103|O2|Outcome|Improving Nutrition, Fitness and Injury Prevention|"The goals are: (1) maintain and improve nutrition and physical fitness through healthier lifestyle and food choices; (2) reduce the risk of sports or physical training injuries and learning how to treat injuries; and (3) Learn to recognize stress and the steps you can take to reduce stress~Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
304406|NCT01234103|O1|Outcome|Preventing Sexual Health Risks|"The over goal is to prevent STIs, unintended pregnancies, and related behaviors including sexual risk, alcohol and other substance misuse~Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
304407|NCT01234103|O2|Outcome|Improving Nutrition, Fitness and Injury Prevention|"The goals are: (1) maintain and improve nutrition and physical fitness through healthier lifestyle and food choices; (2) reduce the risk of sports or physical training injuries and learning how to treat injuries; and (3) Learn to recognize stress and the steps you can take to reduce stress~Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
304408|NCT01234103|O1|Outcome|Preventing Sexual Health Risks|"The over goal is to prevent STIs, unintended pregnancies, and related behaviors including sexual risk, alcohol and other substance misuse~Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
304409|NCT01234103|E2|Reported Event|Improving Nutrition, Fitness and Injury Prevention|"The goals are: (1) maintain and improve nutrition and physical fitness through healthier lifestyle and food choices; (2) reduce the risk of sports or physical training injuries and learning how to treat injuries; and (3) Learn to recognize stress and the steps you can take to reduce stress~Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
304410|NCT01234103|E1|Reported Event|Preventing Sexual Health Risks|"The over goal is to prevent STIs, unintended pregnancies, and related behaviors including sexual risk, alcohol and other substance misuse~Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
304412|NCT01233999|P1|Participant Flow|Botox|Participants will be randomly assigned to receive 1 injection with Botulinum toxin A, 40 units in either the left or right hand.
304413|NCT01233999|O1|Outcome|Botox|single-drug dosage comparison cross-over study
304414|NCT01233999|E1|Reported Event|Botox|single-drug dosage comparison cross-over study
304415|NCT01233921|B3|Baseline|Total|Total of all reporting groups
304416|NCT01233921|B2|Baseline|Arm II (no Palifermin)|Patients do not receive palifermin.
304417|NCT01233921|B1|Baseline|Arm I (Palifermin)|Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
304418|NCT01233921|P2|Participant Flow|Arm II (no Palifermin)|Patients do not receive palifermin.
304419|NCT01233921|P1|Participant Flow|Arm I (Palifermin)|Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
304420|NCT01233921|O2|Outcome|Arm II (no Palifermin)|Patients do not receive palifermin.
304421|NCT01233921|O1|Outcome|Arm I (Palifermin)|Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
304422|NCT01233921|O2|Outcome|Arm II (no Palifermin)|Patients do not receive palifermin.
304423|NCT01233921|O1|Outcome|Arm I (Palifermin)|Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
304424|NCT01233921|E2|Reported Event|Arm II (no Palifermin)|Patients do not receive palifermin.
304425|NCT01233921|E1|Reported Event|Arm I (Palifermin)|Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
304426|NCT01233869|B5|Baseline|Total|Total of all reporting groups
304427|NCT01233869|B4|Baseline|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
304428|NCT01233869|B3|Baseline|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
304429|NCT01233869|B2|Baseline|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
304430|NCT01233869|B1|Baseline|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
304431|NCT01233869|P4|Participant Flow|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
304432|NCT01233869|P3|Participant Flow|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
304433|NCT01233869|P2|Participant Flow|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
304434|NCT01233869|P1|Participant Flow|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
304435|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
304436|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
304437|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
304438|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
304439|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
304440|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
304441|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
304442|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
304719|NCT01233232|O1|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
304443|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
304444|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
304445|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
304446|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
304447|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
304448|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
304449|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
304450|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
304451|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
304452|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
304453|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
304454|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
304455|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
304456|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
304457|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
304458|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
304459|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
304460|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
304461|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
304462|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
304463|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
304600|NCT01233609|E1|Reported Event|Placebo|"Subjects who receive placebo~Placebo: Dosage per subject weight- same schedule as the active comparator"
304464|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
304465|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
304466|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
304467|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
304468|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
304469|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
304470|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
304471|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
304472|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
304473|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
304474|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
304475|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
304476|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
304477|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
304478|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
304479|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
304480|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
304481|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
304482|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
304483|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
304484|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
304720|NCT01233232|O2|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
304485|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
304486|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
304487|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
304488|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
304489|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
304490|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
304491|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
304492|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
304493|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
304494|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
304495|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
304496|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
304497|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
304498|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
304499|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
304500|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
304501|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
304502|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
304503|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
304504|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
304505|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
304506|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
304507|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
304508|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
304509|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
304510|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
304511|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
304512|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
304513|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
304514|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
304515|NCT01233869|E4|Reported Event|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
304516|NCT01233869|E3|Reported Event|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
304517|NCT01233869|E2|Reported Event|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
304518|NCT01233869|E1|Reported Event|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
304519|NCT01233817|B1|Baseline|Spinal Muscular Atrophy|Children and adolescents with diagnosis of SMA type II or III
304520|NCT01233817|P1|Participant Flow|Spinal Muscular Atrophy|Children and adolescents with diagnosis of SMA type II or III
304521|NCT01233817|O1|Outcome|Spinal Muscular Atrophy|Children and adolescents with diagnosis of SMA type II or III
304522|NCT01233817|E1|Reported Event|Spinal Muscular Atrophy|Children and adolescents with diagnosis of SMA type II or III
304523|NCT01233726|B4|Baseline|Total|Total of all reporting groups
304524|NCT01233726|B3|Baseline|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Nutrition, Madrid, Spain) as unique nutritional support throughout the day, receiving 25 kcal / kg / day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~GLUCERNA SELECT group received 25 kcal / kg / day for 28 days, via gastric or transpyloric."
304525|NCT01233726|B2|Baseline|ISOSOURCE PROTEIN FIBRE|"Patients of this group will received ISOSOURCE PROTEIN FIBRE (Nestlé Health Science, barcelona, Spain) as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~ISOSOURCE PROTEIN FIBRE group received, 25 kcal / kg / day for 28 days, via gastric or transpyloric."
304526|NCT01233726|B1|Baseline|DIABA HP|"Patients of this group received new-generation diabetes-specific high-protein formula (Diaba HP®, Vegenat, Badajoz, Spain); as unique nutritional support throughout the day, receiving 25 kcal / kg / day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~DIABA HP group received, 25 kcal / kg/ day for 28 days, via gastric or transpyloric."
304527|NCT01233726|P3|Participant Flow|GLUCERNA SELECT|"Patients of this group received GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~GLUCERNA SELECT group will received 25 kcal / kg / day for 28 days, via gastric or transpyloric."
304528|NCT01233726|P2|Participant Flow|ISOSOURCE PROTEIN FIBRE|"Patients of this group received ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~ISOSOURCE PROTEIN FIBRE group received, 25 kcal / kg / day for 28 days, via gastric or transpyloric."
304601|NCT01233284|B1|Baseline|Baseline Total|Total number of patients randomised and treated in the study.
304529|NCT01233726|P1|Participant Flow|DIABA HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~DIABA HP group received, 25 kcal / kg /day for 28 days, via gastric or transpyloric."
304530|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
304531|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
304532|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~Group Diaba HP received, 25 kcal / kg /day for 28 days"
304533|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~GLUCERNA SELECT group will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
304534|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~ISOSOURCE PROTEIN FIBRE group will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
304535|NCT01233726|O1|Outcome|DIABA HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~DIABA HP GROUP received, 25 kcal / kg /day for 28 days, via gastric or transpyloric."
304536|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~GLUCERNA SELECT group will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
304537|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~ISOSOURCE PROTEIN FIBRE group will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
304538|NCT01233726|O1|Outcome|DIABA HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~DIABA HP GROUP received, 25 kcal / kg /day for 28 days, via gastric or transpyloric."
304539|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~GLUCERNA SELECT group will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
304540|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~ISOSOURCE PROTEIN FIBRE group will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
304541|NCT01233726|O1|Outcome|DIABA HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~DIABA HP GROUP received, 25 kcal / kg /day for 28 days, via gastric or transpyloric."
304542|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
304543|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
304544|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~Group Diaba HP received, 25 kcal / kg /day for 28 days"
304545|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
304546|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
304547|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~Group Diaba HP received, 25 kcal / kg /day for 28 days"
304548|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
304549|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
304550|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~Group Diaba HP received, 25 kcal / kg /day for 28 days"
304551|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
304552|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
304553|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~Group Diaba HP received, 25 kcal / kg /day for 28 days"
304554|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
304555|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
304556|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~Group Diaba HP received, 25 kcal / kg /day for 28 days"
304557|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
304558|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
304712|NCT01233232|P3|Participant Flow|AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
304559|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~Group Diaba HP received, 25 kcal / kg /day for 28 days"
304560|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
304561|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
304562|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~Group Diaba HP received, 25 kcal / kg /day for 28 days"
304563|NCT01233726|E3|Reported Event|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg/ day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~GLUCERNA SELECT group will receive 25 kcal / kg / day for 28 days, via gastric or transpyloric."
304564|NCT01233726|E2|Reported Event|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg / day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~ISOSOURCE PROTEIN FIBRE group received, 25 kcal / kg / day for 28 days, via gastric or transpyloric."
304565|NCT01233726|E1|Reported Event|DIABA HP|"Patients of this group received Diaba HP® as unique nutritional support throughout the day, receiving 25 kcal / kg / day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~DIABA HP group received, 25 kcal / kg /day for 28 days, via gastric or transpyloric."
304566|NCT01233687|B1|Baseline|AMG 102 + Erlotinib|
304567|NCT01233687|P1|Participant Flow|AMG 102 + Erlotinib|
304568|NCT01233687|O1|Outcome|AMG 102 + Erlotinib|
304569|NCT01233687|O1|Outcome|AMG 102 + Erlotinib|
304570|NCT01233687|O1|Outcome|AMG 102 + Erlotinib|
304571|NCT01233687|O1|Outcome|AMG 102 + Erlotinib|
304572|NCT01233687|O1|Outcome|AMG 102 + Erlotinib|
304573|NCT01233687|E1|Reported Event|AMG 102 + Erlotinib|"Serious and Non-Serious Adverse Events include the events considered at least possibly, probably or definitely related to study treatment.~Non-Serious (Other) Adverse Events include those that occurred with a frequency of more than or equal to 5%."
304574|NCT01233609|B3|Baseline|Total|Total of all reporting groups
304575|NCT01233609|B2|Baseline|Valproic Acid|"Subjects who receive valproic acid~Valproic Acid: One to four 250mg softgels by mouth daily (dose determined by body weight)"
304576|NCT01233609|B1|Baseline|Placebo|"Subjects who receive placebo~Placebo: Dosage per subject weight- same schedule as the active comparator"
304577|NCT01233609|P2|Participant Flow|Placebo|"Subjects who receive placebo~Placebo: Dosage per subject weight- same schedule as the active comparator"
304578|NCT01233609|P1|Participant Flow|Valproic Acid|"Subjects who receive valproic acid~Valproic Acid: One to four 250mg softgels by mouth daily (dose determined by body weight)"
304579|NCT01233609|O4|Outcome|Placebo --Left Eye|Results from the Left Eye in Patients treated with Placebo
304580|NCT01233609|O3|Outcome|Placebo --Right Eye|Results from the Right Eye in Patients treated with Placebo
304581|NCT01233609|O2|Outcome|Valproic Acid--Left Eye|Results from the Left Eye in Patients treated with Valproic Acid
304582|NCT01233609|O1|Outcome|Valproic Acid -- Right Eye|Results from the Right Eye in Patients treated with Valproic Acid
304583|NCT01233609|O4|Outcome|Valproic Acid--Left Eye|Left eye of Valproic Acid-treated patients
304584|NCT01233609|O3|Outcome|Valproic Acid--Right Eye|Right eye of Valproic acid-treated patients
304585|NCT01233609|O2|Outcome|Placebo--Left Eye|Left eye of Placebo-treated patients
304586|NCT01233609|O1|Outcome|Placebo--Right Eye|Right eye of placebo-treated patients
304587|NCT01233609|O4|Outcome|Valproic Acid--Left Eye|Left eye of Valproic acid-treated patients
304588|NCT01233609|O3|Outcome|Valproic Acid--Right Eye|Right eye of Valproic acid-treated patients
304589|NCT01233609|O2|Outcome|Placebo--Left Eye|Left eye of Placebo-treated patients
304590|NCT01233609|O1|Outcome|Placebo--Right Eye|Right eye of Placebo-treated patients
304591|NCT01233609|O4|Outcome|Valproic Acid--Left Eye|Left eye of Valproic Acid-treated patients
304592|NCT01233609|O3|Outcome|Valproic Acid--Right Eye|Right eye of Valproic acid-treated patients
304593|NCT01233609|O2|Outcome|Placebo--Left Eye|Left eye of Placebo-treated patients
304594|NCT01233609|O1|Outcome|Placebo--Right Eye|Right eye of Placebo-treated patients
304595|NCT01233609|O4|Outcome|Valproic Acid--Left Eye|Left eye of Valproic acid-treated patients
304596|NCT01233609|O3|Outcome|Valproic Acid--Right Eye|Right eye of Valproic acid-treated patients
304597|NCT01233609|O2|Outcome|Placebo--Left Eye|Left eye of Placebo-treated patients
304598|NCT01233609|O1|Outcome|Placebo--Right Eye|Right eye of Placebo-treated patients
304599|NCT01233609|E2|Reported Event|Valproic Acid|"Subjects who receive valproic acid~Valproic Acid: One to four 250mg softgels by mouth daily (dose determined by body weight)"
304602|NCT01233284|P5|Participant Flow|Placebo/Tio R2.5 qd/Tio R5 qd/Tio R1.25 qd|Patient treated with a matching Placebo in period 1 (evening), with Tiotropium 2.5 mcg in period 2 (evening), with Tiotropium 5 mcg in period 3 (evening) and with Tiotropium 1.25 mcg in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to ICS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
304603|NCT01233284|P4|Participant Flow|Placebo/Tio R5 qd/Tio R2.5 qd/Tio R1.25 qd|Patients treated with a matching Placebo in period 1 (evening), with Tiotropium 5 mcg in period 2 (evening), with Tiotropium 2.5 mcg in period 3 (evening) and with Tiotropium 1.25 mcg in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to ICS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
304604|NCT01233284|P3|Participant Flow|Tio R1.25 qd/Tio R2.5 qd/Tio R5 qd/Placebo|Patients treated with Tiotropium 1.25 mcg in period 1 (evening), with Tiotropium 2.5 mcg in period 2 (evening), with Tiotropium 5 mcg in period 3 (evening) and with a matching placebo in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to inhaled corticosteroid ICS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
304605|NCT01233284|P2|Participant Flow|Tio R2.5 qd/Placebo/Tio R1.25 qd/Tio R5 qd|Patients treated with Tiotropium 2.5 mcg in period 1 (evening), with a matching Placebo in period 2 (evening), with Tiotropium 1.25 mcg in period 3 (evening) and with Tiotropium 5 mcg in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to ICS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
304606|NCT01233284|P1|Participant Flow|Tio R5 Once Daily(qd)/Tio R1.25 qd/Placebo/Tio R2.5 qd|Patients treated with Tiotropium 5 mcg in period 1 (evening), with Tiotropium 1.25 mcg in period 2 (evening), with a matching Placebo in period 3 (evening) and with Tiotropium 2.5 mcg in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to inhaled corticosteroids (ICS). No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
304607|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304608|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304609|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304610|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
304611|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304612|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304613|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304614|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
304615|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304616|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304617|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304618|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
304619|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304620|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304621|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304622|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
304623|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304624|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304625|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304626|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
304627|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304628|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304629|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304630|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
304631|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304632|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304633|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304634|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
304635|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304636|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304637|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304638|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
304639|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304640|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
308157|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
304641|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304642|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
304643|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304644|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304645|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304646|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
304647|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304648|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304649|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304650|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
304651|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304652|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304653|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304654|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
304655|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304656|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304657|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304658|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
304659|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304660|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304661|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304662|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
304663|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304664|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304665|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304666|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
304667|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304668|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304669|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304670|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
304671|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304672|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304673|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304674|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
304675|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304676|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304677|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304678|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
304679|NCT01233284|E4|Reported Event|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304680|NCT01233284|E3|Reported Event|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304681|NCT01233284|E2|Reported Event|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
304682|NCT01233284|E1|Reported Event|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
304683|NCT01233258|B4|Baseline|Total|Total of all reporting groups
304684|NCT01233258|B3|Baseline|rFVIII (BAY81-8973) Prophylaxis High-dose|Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.
304685|NCT01233258|B2|Baseline|rFVIII (BAY81-8973) Prophylaxis Low-dose|Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.
304686|NCT01233258|B1|Baseline|rFVIII (BAY81-8973) on Demand|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
304713|NCT01233232|P2|Participant Flow|AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
304714|NCT01233232|P1|Participant Flow|Placebo|4 x placebo capsules, twice daily (bid)
304687|NCT01233258|P6|Participant Flow|High Dose Prophylaxis, BAY 81-8973 Potency First ADJ Then EP|Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII(BAY81-8973) measured by CS/ADJ for 6 months then crossed over to study drug measured by CS/ EP for 6 months.
304688|NCT01233258|P5|Participant Flow|High Dose Prophylaxis, BAY 81-8973 Potency First EP Then ADJ|Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII (BAY81-8973) measured by CS/ EP for 6 months then crossed over to study drug measured by CS/ADJ for 6 months.
304689|NCT01233258|P4|Participant Flow|Low Dose Prophylaxis, BAY 81-8973 Potency First ADJ Then EP|Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII (BAY81-8973) measured by CS/ADJ for 6 months then crossed over to study drug measured by CS/ EP for 6 months.
304690|NCT01233258|P3|Participant Flow|Low Dose Prophylaxis, BAY 81-8973 Potency First EP Then ADJ|Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII(BAY81-8973) measured by CS/ EP for 6 months then crossed over to study drug measured by CS/ADJ for 6 months.
304691|NCT01233258|P2|Participant Flow|On Demand, BAY 81-8973 Potency First ADJ Then EP|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/ADJ for 6 months, followed by cross-over to study drug assayed by CS/EP for 6 months.
304692|NCT01233258|P1|Participant Flow|On Demand, BAY 81-8973 Potency First EP Then ADJ|Participants received on-demand treatment with recombinant factor VIII (rFVIII, BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months, followed by cross-over to study drug assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months.
304693|NCT01233258|O3|Outcome|rFVIII (BAY81-8973) Prophylaxis High-dose|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at high-dose (30, 35 or 40 IU/kg 3 times per week ) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
304694|NCT01233258|O2|Outcome|rFVIII (BAY81-8973) Prophylaxis Low-dose|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
304695|NCT01233258|O1|Outcome|rFVIII (BAY81-8973) on Demand|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
304696|NCT01233258|O3|Outcome|rFVIII (BAY81-8973) Prophylaxis High-dose|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at high-dose (30, 35 or 40 IU/kg 3 times per week) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization
304697|NCT01233258|O2|Outcome|rFVIII (BAY81-8973) Prophylaxis Low-dose|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization
304698|NCT01233258|O1|Outcome|rFVIII (BAY81-8973) on Demand|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
304699|NCT01233258|O2|Outcome|rFVIII (BAY81-8973) on Demand Assayed by CS/ADJ|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months
304700|NCT01233258|O1|Outcome|rFVIII (BAY81-8973) on Demand Assayed by CS/EP|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months
304701|NCT01233258|O2|Outcome|rFVIII (BAY81-8973) Prophylaxis Treatment Assayed by CS/ADJ|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week ) and high-dose (30, 35 or 40 IU/kg 3 times per week ) assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months
304702|NCT01233258|O1|Outcome|rFVIII (BAY81-8973) on Demand Assayed by CS/ADJ|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months
304703|NCT01233258|O2|Outcome|rFVIII (BAY81-8973) Prophylaxis Treatment Assayed by CS/EP|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week ) and high-dose (30, 35 or 40 IU/kg 3 times per week ) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months.
304704|NCT01233258|O1|Outcome|rFVIII (BAY81-8973) on Demand Assayed by CS/EP|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months
304705|NCT01233258|O2|Outcome|rFVIII (BAY81-8973) Prophylaxis Treatment|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week ) and high-dose (30, 35 or 40 IU/kg 3 times per week ) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
304706|NCT01233258|O1|Outcome|rFVIII (BAY81-8973) on Demand|Participants received on-demand treatment rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization
304707|NCT01233258|E1|Reported Event|rFVIII (BAY81-8973) Treatment|Participants received on-demand or prophylaxis treatment with recombinant factor VIII (rFVIII, BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization
304708|NCT01233232|B4|Baseline|Total|Total of all reporting groups
304709|NCT01233232|B3|Baseline|AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
304710|NCT01233232|B2|Baseline|AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
304711|NCT01233232|B1|Baseline|Placebo|4 x placebo capsules, twice daily (bid)
304721|NCT01233232|O1|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
304722|NCT01233232|O2|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
304723|NCT01233232|O1|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
304724|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
304725|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
304726|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
304727|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
304728|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
304729|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
304730|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
304731|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
304732|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
304733|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
304734|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
304735|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
304736|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
304737|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
304738|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
304739|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
304740|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
304741|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
304742|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
304743|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
304744|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
304745|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
304746|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
304747|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
304748|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
304749|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
304750|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
304751|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
304752|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
304753|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
304754|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
304755|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
304756|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
304757|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
304758|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
304759|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
304760|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
304761|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
304762|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
304763|NCT01233232|E3|Reported Event|AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
304764|NCT01233232|E2|Reported Event|AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
304765|NCT01233232|E1|Reported Event|Placebo|4 x placebo capsules, twice daily (bid)
304766|NCT01233076|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed participants.
304767|NCT01233076|P2|Participant Flow|Narafilcon B / Nelfilcon A|Narafilcon B worn first, with nelfilcon A worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
304768|NCT01233076|P1|Participant Flow|Nelfilcon A / Narafilcon B|Nelfilcon A worn first, with narafilcon B worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
304769|NCT01233076|O2|Outcome|Narafilcon B|Commercially marketed (US), spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week.
304770|NCT01233076|O1|Outcome|Nelfilcon A|Commercially marketed, spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week.
304771|NCT01233076|E2|Reported Event|Narafilcon B|Commercially marketed (US), spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week.
304772|NCT01233076|E1|Reported Event|Nelfilcon A|Commercially marketed, spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week.
304773|NCT01233050|B3|Baseline|Total|Total of all reporting groups
304774|NCT01233050|B2|Baseline|Iodine Povacrylex-Alcohol|"Preoperative Skin Antisepsis Preparation~Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation"
304775|NCT01233050|B1|Baseline|Chlorhexidine-Alcohol|"Preoperative Skin Antisepsis Preparation~2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation"
304776|NCT01233050|P2|Participant Flow|Iodine Povacrylex-Alcohol|"Preoperative Skin Antisepsis Preparation~Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation"
304777|NCT01233050|P1|Participant Flow|Chlorhexidine-Alcohol|"Preoperative Skin Antisepsis Preparation~2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation"
304778|NCT01233050|O2|Outcome|Iodine Povacrylex-Alcohol|"Preoperative Skin Antisepsis Preparation~Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation"
304779|NCT01233050|O1|Outcome|Chlorhexidine-Alcohol|"Preoperative Skin Antisepsis Preparation~2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation"
304780|NCT01233050|O2|Outcome|Iodine Povacrylex-Alcohol|"Preoperative Skin Antisepsis Preparation~Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation"
304781|NCT01233050|O1|Outcome|Chlorhexidine-Alcohol|"Preoperative Skin Antisepsis Preparation~2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation"
304782|NCT01233050|O2|Outcome|Iodine Povacrylex-Alcohol|"Preoperative Skin Antisepsis Preparation~Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation"
304783|NCT01233050|O1|Outcome|Chlorhexidine-Alcohol|"Preoperative Skin Antisepsis Preparation~2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation"
304784|NCT01233050|O2|Outcome|Iodine Povacrylex-Alcohol|"Preoperative Skin Antisepsis Preparation~Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation"
304785|NCT01233050|O1|Outcome|Chlorhexidine-Alcohol|"Preoperative Skin Antisepsis Preparation~2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation"
304786|NCT01233050|O2|Outcome|Iodine Povacrylex-Alcohol|"Preoperative Skin Antisepsis Preparation~Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation"
304787|NCT01233050|O1|Outcome|Chlorhexidine-Alcohol|"Preoperative Skin Antisepsis Preparation~2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation"
304788|NCT01233050|O2|Outcome|Iodine Povacrylex-Alcohol|"Preoperative Skin Antisepsis Preparation~Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation"
304789|NCT01233050|O1|Outcome|Chlorhexidine-Alcohol|"Preoperative Skin Antisepsis Preparation~2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation"
304790|NCT01233050|E2|Reported Event|Iodine Povacrylex-Alcohol|"Preoperative Skin Antisepsis Preparation~Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation"
304791|NCT01233050|E1|Reported Event|Chlorhexidine-Alcohol|"Preoperative Skin Antisepsis Preparation~2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation"
304792|NCT01232920|B3|Baseline|Total|Total of all reporting groups
304793|NCT01232920|B2|Baseline|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
304794|NCT01232920|B1|Baseline|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
304795|NCT01232920|P2|Participant Flow|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
304796|NCT01232920|P1|Participant Flow|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
304797|NCT01232920|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
304798|NCT01232920|O1|Outcome|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
304818|NCT01232868|B1|Baseline|Age 25-40 Years|Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
304819|NCT01232868|P2|Participant Flow|Age ≥65 Years|Healthy participants 65 years or older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
304799|NCT01232920|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
304800|NCT01232920|O1|Outcome|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
304801|NCT01232920|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
304802|NCT01232920|O1|Outcome|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
304803|NCT01232920|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
304804|NCT01232920|O1|Outcome|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
304805|NCT01232920|E2|Reported Event|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
304806|NCT01232920|E1|Reported Event|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
304807|NCT01232894|B3|Baseline|Total|Total of all reporting groups
304808|NCT01232894|B2|Baseline|Long-acting beta2-agonist|Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
304809|NCT01232894|B1|Baseline|Indacaterol|indacaterol 150 µg once-daily via single-dose dry powder inhaler
304810|NCT01232894|P2|Participant Flow|Long-acting beta2-agonist|Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
304811|NCT01232894|P1|Participant Flow|Indacaterol|indacaterol 150 µg once-daily via single-dose dry powder inhaler
304812|NCT01232894|O2|Outcome|Long-acting beta2-agonist|Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
304813|NCT01232894|O1|Outcome|Indacaterol|indacaterol 150 µg once-daily via single-dose dry powder inhaler
304814|NCT01232894|E2|Reported Event|Long-acting beta2-agonist|Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
304815|NCT01232894|E1|Reported Event|Indacaterol|indacaterol 150 µg once-daily via single-dose dry powder inhaler
304816|NCT01232868|B3|Baseline|Total|Total of all reporting groups
304817|NCT01232868|B2|Baseline|Age ≥65 Years|Healthy participants 65 years and older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
304910|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
304820|NCT01232868|P1|Participant Flow|Age 25-40 Years|Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
304821|NCT01232868|O2|Outcome|Age ≥65 Years|Healthy participants 65 years and older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
304822|NCT01232868|O1|Outcome|Age 25-40 Years|Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
304823|NCT01232868|O2|Outcome|Age ≥65 Years|Healthy participants 65 years and older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
304824|NCT01232868|O1|Outcome|Age 25-40 Years|Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
304825|NCT01232868|E2|Reported Event|Age ≥65 Years|Healthy participants 65 years or older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
304826|NCT01232868|E1|Reported Event|Age 25-40 Years|Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
304827|NCT01232829|B1|Baseline|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
304828|NCT01232829|P1|Participant Flow|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
304829|NCT01232829|O1|Outcome|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
304830|NCT01232829|O1|Outcome|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
304831|NCT01232829|O1|Outcome|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
304832|NCT01232829|E1|Reported Event|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
304833|NCT01232790|B1|Baseline|Participants|This is the overall group of trial participants prior to randomization to either of the two crossover arms in the study.
304834|NCT01232790|P2|Participant Flow|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days , then receives commercially available sustained release form of NAC for the same period (8 total doses over 5 days).
304835|NCT01232790|P1|Participant Flow|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
304836|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days , then receives commercially available sustained release form of NAC for the same period (8 total doses over 5 days).
304837|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
304838|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days , then receives commercially available sustained release form of NAC for the same period (8 total doses over 5 days).
304839|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
304840|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days , then receives commercially available sustained release form of NAC for the same period (8 total doses over 5 days).
304841|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
304842|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
304843|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
304844|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
304845|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
304846|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
304847|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
304848|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
304849|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
304850|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
304851|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
304852|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
304853|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
304854|NCT01232790|O2|Outcome|Placebo|This is the combined placebo group (both those receiving the placebo first and those receiving the placebo second).
304855|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
304856|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
304857|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
304858|NCT01232790|O2|Outcome|Placebo|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
304859|NCT01232790|O1|Outcome|Intervention|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
304860|NCT01232790|O2|Outcome|Placebo|This is the combined placebo group (both those receiving the placebo first and those receiving the placebo second).
304861|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
304862|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
304863|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
304864|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
304865|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
304866|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
304867|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
304911|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
304912|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
304868|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
304869|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
304870|NCT01232790|O2|Outcome|Placebo|This is the combined placebo/control group (both those receiving the placebo first and those receiving the placebo second).
304871|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
304872|NCT01232790|O2|Outcome|Placebo|This is the combined placebo/control group (both those receiving the placebo first and those receiving the placebo second).
304873|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
304874|NCT01232790|O2|Outcome|Placebo|This is the combined placebo/control group (both those receiving the placebo first and those receiving the placebo second).
304875|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
304876|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and the receives rge commercially available sustained release form of NAC, in each arm the capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
304877|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
304878|NCT01232790|O2|Outcome|Placebo|This is the combined placebo group (both those receiving the placebo first and those receiving the placebo second).
304879|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
304880|NCT01232790|O2|Outcome|Placebo|This is the combined placebo group (both those receiving the placebo first and those receiving the placebo second).
304881|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
304882|NCT01232790|O2|Outcome|Placebo|This is the combined placebo group (both those receiving the placebo first and those receiving the placebo second).
304883|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
304884|NCT01232790|E4|Reported Event|NAC: Second Crossover Follow Up|This group of participants received the active treatment (NAC) on the second day of the crossover study.
304885|NCT01232790|E3|Reported Event|Placebo: Second Crossover Follow Up|This group of participants received the placebo on the second day in the crossover design.
304886|NCT01232790|E2|Reported Event|NAC: First Crossover Follow Up|This group of participants received the active treatment (NAC) on the first day of the crossover study.
304887|NCT01232790|E1|Reported Event|Placebo: First Crossover Follow Up|This group of participants received the placebo on the first day in the crossover design.
304888|NCT01232738|B1|Baseline|Rasagiline|Open label study of 2 mg rasagiline daily
304889|NCT01232738|P1|Participant Flow|Rasagiline|Open label study of rasagiline at 2 mg daily for 12 months
304890|NCT01232738|O1|Outcome|Rasagiline|Open label study of rasagiline at 2 mg daily for 12 months
304891|NCT01232738|O1|Outcome|Rasagiline|Open label study of rasagiline at 2 mg daily for 12 months
304892|NCT01232738|O1|Outcome|Rasagiline|Open label study of rasagiline at 2 mg daily for 12 months
304893|NCT01232738|O1|Outcome|Rasagiline|Open label study of rasagiline at 2 mg daily for 12 months
304894|NCT01232738|O1|Outcome|Rasagiline|Open label study of rasagiline at 2 mg daily for 12 months
304895|NCT01232738|O1|Outcome|Rasagiline|Open label study of rasagiline at 2 mg daily for 12 months
304896|NCT01232738|O1|Outcome|Rasagiline|Open label study of rasagiline at 2 mg daily for 12 months
304897|NCT01232738|O2|Outcome|Difference in Time to Treatment Failure - Historical Control|Historical Controls were from the previous ALS trials.
304898|NCT01232738|O1|Outcome|Difference in Time to Treatment Failure - Rasagiline|This group is defined as death, endotracheal intubation, tracheostomy-assisted ventilation or noninvasive ventilation >=23 hours/day for 14 days.
304899|NCT01232738|O2|Outcome|ALSFRS-R - Historical Placebo Control|Change in slope in the Historical Placebo Control group
304900|NCT01232738|O1|Outcome|ALSRFS-R Slope - Rasagiline|Change in ALSRFS-R at 12 months
304901|NCT01232738|E1|Reported Event|Rasagiline|"Treated for 12 months with rasagiline 2mg orally, once daily.~rasagiline: rasagiline 2 mg daily for 12 months"
304902|NCT01232569|B3|Baseline|Total|Total of all reporting groups
304903|NCT01232569|B2|Baseline|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
304904|NCT01232569|B1|Baseline|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
304905|NCT01232569|P4|Participant Flow|Tocilizumab Auto-injector - Open-label Extension Period|Patients received tocilizumab 162 mg sc via auto-injector every 2 weeks for 72 weeks.
304906|NCT01232569|P3|Participant Flow|Tocilizumab Pre-filled Syringe - Open-label Extension Period|Patients received tocilizumab 162 mg sc via a pre-filled syringe every 2 weeks for 72 weeks.
304907|NCT01232569|P2|Participant Flow|Placebo sc - Double-blind Treatment Period|Patients received placebo sc every 2 weeks for 24 weeks.
304908|NCT01232569|P1|Participant Flow|Tocilizumab 162 mg sc - Double-blind Treatment Period|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
304909|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
304913|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
304914|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
304915|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
304916|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
304917|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
304918|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
304919|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
304920|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
304921|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
304922|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
304923|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
304924|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
304925|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
304926|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
304927|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
304928|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
304929|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
304930|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
304931|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
304932|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
304933|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
304934|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
304935|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
304936|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
304937|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
304938|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
304939|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
304940|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
304941|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
304942|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
304943|NCT01232569|E5|Reported Event|Placebo Pre-filled Syringe to Tocilizumab Autoinjector|Patients received placebo sc via a pre-filled syringe every 2 weeks for 24 weeks followed by tocilizumab162 mg sc via an autoinjector every 2 weeks for 72 weeks.
304944|NCT01232569|E4|Reported Event|Placebo Pre-filled Syringe to Tocilizumab Pre-filled Syringe|Patients received placebo sc via a pre-filled syringe every 2 weeks for 24 weeks followed by tocilizumab162 mg sc via a pre-filled syringe every 2 weeks for 72 weeks.
304945|NCT01232569|E3|Reported Event|Tocilizumab Pre-filled Syringe to Tocilizumab Auto-injector|Patients received tocilizumab 162 mg sc via a pre-filled syringe every 2 weeks for 24 weeks followed by tocilizumab162 mg sc via an autoinjector every 2 weeks for 72 weeks.
304946|NCT01232569|E2|Reported Event|Placebo Pre-filled Syringe|Patients received placebo subcutaneously (sc) via a pre-filled syringe every 2 weeks for 24 weeks.
304947|NCT01232569|E1|Reported Event|Tocilizumab Pre-filled Syringe|Patients received tocilizumab 162 mg sc via a pre-filled syringe every 2 weeks for 24 weeks. In addition, this reporting group includes participants re-randomized at Week 24 to tocilizumab 162 mg sc via a pre-filled syringe every 2 weeks for 72 weeks (Weeks 25-96).
304948|NCT01232504|B4|Baseline|Total|Total of all reporting groups
304949|NCT01232504|B3|Baseline|rhG-CSF Group|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304950|NCT01232504|B2|Baseline|rhG-CSF+ rhGM-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304951|NCT01232504|B1|Baseline|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304952|NCT01232504|P3|Participant Flow|rhG-CSF Group|subcutaneous recombinant human granulocyte stimulating factor (rhGM-CSF) 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304953|NCT01232504|P2|Participant Flow|rhG-CSF+ rhGM-CSF Group|a combination of 2-3μg/kg/d recombinant human granulocyte-macrophage stimulating factor (rhGM-CSF) and 2-3μg/kg/d recombinant human granulocyte stimulating factor (rhG-CSF) each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304954|NCT01232504|P1|Participant Flow|rhGM-CSF Group|subcutaneous recombinant human granulocyte-macrophage stimulating factor (rhGM-CSF) 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304955|NCT01232504|O3|Outcome|rhG-CSFgroup|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304956|NCT01232504|O2|Outcome|rhGM-CSF+ rhG-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304957|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304958|NCT01232504|O3|Outcome|rhG-CSFgroup|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304959|NCT01232504|O2|Outcome|rhGM-CSF+ rhG-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304960|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304961|NCT01232504|O3|Outcome|rhG-CSFgroup|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304962|NCT01232504|O2|Outcome|rhGM-CSF+ rhG-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304963|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304964|NCT01232504|O3|Outcome|rhG-CSFgroup|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304965|NCT01232504|O2|Outcome|rhGM-CSF+ rhG-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304966|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304967|NCT01232504|O3|Outcome|rhG-CSFgroup|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304968|NCT01232504|O2|Outcome|rhGM-CSF+ rhG-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304969|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304970|NCT01232504|O3|Outcome|rhG-CSF Group|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304971|NCT01232504|O2|Outcome|rhG-CSF+ rhGM-CSF|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304972|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304973|NCT01232504|O3|Outcome|rhG-CSF|"5-7μg/kg per day~rhG-CSF: 5-7μg/kg daily subcutaneously（sc）without interruption until neutrophils≥1.5×10(9)/L for two continuous days,starting 5 days after transplantation."
304974|NCT01232504|O2|Outcome|rhGM-CSF Plus rhG-CSF|"rhGM-CSF and rhG-CSF both at 2-3μg/kg per day~rhGM-CSF plus rhG-CSF: rhGM-CSF and rhG-CSF (both at 2-3μg/kg/d) subcutaneously（sc）without interruption until neutrophils≥1.5×10(9)/L for two continuous days,starting 5 days after transplantation."
304975|NCT01232504|O1|Outcome|rhGM-CSF|"5-7μg/kg per day~rhGM-CSF: 5-7μg/kg daily subcutaneously（sc）without interruption until neutrophils≥1.5×10(9)/L for two continuous days,starting 5 days after transplantation."
304976|NCT01232504|O3|Outcome|rhG-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304977|NCT01232504|O2|Outcome|rhG-CSF+ rhGM-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304978|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304979|NCT01232504|O3|Outcome|rhG-CSF Group|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304980|NCT01232504|O2|Outcome|rhG-CSF + rhGM-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304981|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304982|NCT01232504|E3|Reported Event|rhG-CSF Group|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
308158|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
304983|NCT01232504|E2|Reported Event|rhG-CSF + rhGM-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304984|NCT01232504|E1|Reported Event|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
304985|NCT01232491|B3|Baseline|Total|Total of all reporting groups
304986|NCT01232491|B2|Baseline|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
304987|NCT01232491|B1|Baseline|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
304988|NCT01232491|P2|Participant Flow|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
304989|NCT01232491|P1|Participant Flow|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
304990|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
304991|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
304992|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
304993|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
304994|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
304995|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
304996|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
304997|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
304998|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
304999|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
305000|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
305001|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
305002|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
305003|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
305163|NCT01231646|O2|Outcome|Valproate|Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine.
305004|NCT01232491|E2|Reported Event|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
305005|NCT01232491|E1|Reported Event|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
305006|NCT01232465|B3|Baseline|Total|Total of all reporting groups
305007|NCT01232465|B2|Baseline|ICSI|those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)
305008|NCT01232465|B1|Baseline|IVF Cycles|those individuals undergoing conventional IVF to inseminate their retrieved eggs
305009|NCT01232465|P2|Participant Flow|ICSI|those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)
305010|NCT01232465|P1|Participant Flow|IVF Cycles|those individuals undergoing conventional IVF to inseminate their retrieved eggs
305011|NCT01232465|O2|Outcome|ICSI|those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)
305012|NCT01232465|O1|Outcome|IVF Cycles|those individuals undergoing conventional IVF to inseminate their retrieved eggs
305013|NCT01232465|E2|Reported Event|ICSI|those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)
305014|NCT01232465|E1|Reported Event|IVF Cycles|those individuals undergoing conventional IVF to inseminate their retrieved eggs
305015|NCT01232296|B3|Baseline|Total|Total of all reporting groups
305016|NCT01232296|B2|Baseline|Sorafenib|400 mg tablet p.o. b.i.d.
305017|NCT01232296|B1|Baseline|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
305018|NCT01232296|P2|Participant Flow|Sorafenib|400 mg tablet p.o. b.i.d.
305019|NCT01232296|P1|Participant Flow|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
305020|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
305021|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
305022|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
305023|NCT01232296|O2|Outcome|Sorafenib|400 mg tablet p.o. b.i.d.
305024|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
305025|NCT01232296|O2|Outcome|Sorafenib|400 mg tablet p.o. b.i.d.
305026|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
305027|NCT01232296|O2|Outcome|Sorafenib|400 mg tablet p.o. b.i.d.
305028|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
305029|NCT01232296|O2|Outcome|Sorafenib|400 mg tablet p.o. b.i.d.
305030|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
305031|NCT01232296|E2|Reported Event|Sorafenib|400 mg tablet p.o. b.i.d.
305032|NCT01232296|E1|Reported Event|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
305033|NCT01232283|B3|Baseline|Total|Total of all reporting groups
305034|NCT01232283|B2|Baseline|Placebo|Participants were initially randomized to placebo tablets BID during the Placebo controlled Phase (weeks 0-16).
305035|NCT01232283|B1|Baseline|Apremilast|Participants were initially randomized to Apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
305036|NCT01232283|P10|Participant Flow|Placebo-Apremilast (Long-term Extension)|Participants who were initially randomized to identically matching placebo BID during the Placebo-controlled Phase (Weeks 0-16) were switched at Week 16 to apremilast 30 mg BID during the Maintenance Phase, received apremilast 30 mg PO BID during the Randomized Withdrawal Phase and then received apremilast 30 mg tablets BID in the long-term extension phase from weeks 52-260.
305037|NCT01232283|P9|Participant Flow|Apremilast (Long-Term Extension Phase)|Participants who were initially randomized to APR 30 mg BID during the 16-week placebo-controlled phase (Weeks 0-16) continued receiving APR 30 mg BID through the Maintenance Phase (weeks 16-32) and apremilast 30 mg tablets or placebo during the Randomized Withdrawal Phase were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and remained on APR 30 mg BID for the remainder of their participation.
305038|NCT01232283|P8|Participant Flow|PBO-APR-APR + Optional Topicals/Phototherapy|Participants who were initially randomized to placebo BID during the 16-week Placebo-controlled Phase (Weeks 0-16) were switched after 16 weeks of treatment to apremilast 30 mg BID and continued dosing with apremilast 30 mg BID during the Maintenance Phase (Weeks 16-32). At week 32, all participants were to maintain apremilast 30 mg BID; those who were non-responders (having a response of <PASI-50), remained on apremilast 30 mg BID and were given the option of adding topical therapies and/or phototherapy to their regimen. A subset of these non-responders received additional topicals or phototherapy. All participants who completed the Randomized Withdrawal Phase at week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and continued on apremilast 30 mg BID for the remainder of their participation
305039|NCT01232283|P7|Participant Flow|APR-APR-APR + Optional Topicals/Phototherapy|Participants who were initially randomized to apremilast 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with apremilast 30 mg BID through the Maintenance Phase (Weeks 16-32). At Week 32, those participants who were considered non-responders (ie, having a response of <PASI-50), remained on apremilast 30 mg BID and were given the option of adding topical therapies and/or phototherapy to their regimen. Those participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and continued on apremilast 30 mg BID for the remainder of their participation.
305040|NCT01232283|P6|Participant Flow|APR-APR Re-randomized to APR|Participants who were initially randomized to apremilast 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with apremilast 30 mg BID through the Maintenance Phase (Weeks 16-32). At week 32, those participants who were considered responders (ie, having a ≥PASI-50 response) were re-randomized to apremilast during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and continued on apremilast 30 mg BID for the remainder of their participation.
308159|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
305041|NCT01232283|P5|Participant Flow|APR-APR-Re-randomized to PBO|Participants who were initially randomized to apremilast 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with apremilast 30 mg BID through the Maintenance Phase (Weeks 16-32). At week 32, those participants who were considered responders (ie, having a ≥PASI-50 response) were re-randomized to placebo during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who lost their PASI-50 improvement achieved at Week 32, were switched back to apremilast 30 mg BID at the time the loss was observed. Those participants who did not lose their PASI-50 response remained on placebo until Week 52. All participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and received apremilast 30 mg BID for the remainder of their participation.
305042|NCT01232283|P4|Participant Flow|Placebo-Apremilast|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were switched after 16 weeks of treatment to apremilast 30 mg BID and continued dosing with apremilast 30 mg BID during the Maintenance Phase (Weeks 16-32).
305043|NCT01232283|P3|Participant Flow|Apremilast-Apremilast|Participants who were initially randomized to apremilast 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 30 mg BID during the Maintenance Phase (Weeks 16-32).
305044|NCT01232283|P2|Participant Flow|Placebo|Participants initially randomized to identically matching placebo tablets (PBO) BID during the Placebo controlled Phase (Weeks 0-16)
305045|NCT01232283|P1|Participant Flow|Apremilast|Participants initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
305046|NCT01232283|O1|Outcome|Apremilast|Participants who received apremilast 30 mg BID at any time during the study.
305047|NCT01232283|O1|Outcome|Apremilast|Participants who received apremilast 30 mg BID at any time during the study. Participants initially randomized to placebo or apremilast 30 mg tablets BID during the 16-week placebo-controlled phase (Weeks 0-16) continued to receive apremilast 30 mg BID through the maintenance phase; during the randomized withdrawal phase (Weeks 32-52) participants were again randomized to either apremilast 30 mg BID or placebo and were transitioned to apremilast 30 mg BID after loss of response or in the long-term extension phase from Weeks 52-260,
305048|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
305049|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
305050|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (Weeks 0-16)
305051|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16)
305052|NCT01232283|O2|Outcome|APR-APR-Re-randomized to APR|Participants who were initially randomized to apremilast 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with apremilast 30 mg BID through the Maintenance Phase (Weeks 16-32). At week 32, those participants who were considered responders (ie, having a ≥PASI-50 response) were re-randomized to apremilast during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and continued on apremilast 30 mg BID for the remainder of their participation.
305053|NCT01232283|O1|Outcome|APR-APR Re-randomized to PBO|Participants who were initially randomized to apremilast 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with apremilast 30 mg BID through the Maintenance Phase (Weeks 16-32). At week 32, those participants who were considered responders (ie, having a ≥PASI-50 response) were re-randomized to placebo during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who lost their PASI-50 improvement achieved at Week 32, were switched back to apremilast 30 mg BID at the time the loss was observed. Those participants who did not lose their PASI-50 response remained on placebo until Week 52. All participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and received apremilast 30 mg BID for the remainder of their participation.
305054|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16)
305055|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
305056|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
305057|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
305058|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (Weeks 0-16)
305059|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
305060|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16)
305061|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
305062|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo tablets BID during the Placebo-controlled Phase (Weeks 0-16)
305063|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16)
305064|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to placebo tablets BID during the Placebo-controlled Phase (weeks 0-16)
305065|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
305066|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
305067|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
308160|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
305068|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets twice daily BID during the Placebo-controlled Phase (weeks 0-16)
305069|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
305070|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
305071|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
305072|NCT01232283|E4|Reported Event|Apremilast: Weeks 0-260 (APR- Exposure Period )|Participants who received apremilast 30 mg tablets BID, regardless of when the apremilast exposure started (at Week 0 or at Week 16), up until Week 260. Adverse events associated with apremilast 30 mg treatment up to Week 260 were included. AEs that started more than 28 days after placebo treatment and prior to resuming apremilast were excluded for participants who were re-randomized to Placebo at Week 32.
305073|NCT01232283|E3|Reported Event|APR-APR-PBO: Weeks 32-52 (Randomized Withdrawal Phase)|Participants re-randomized to placebo tablets BID at Week 32. Includes data from Week 32 up to Week 52 when participants received placebo treatment.
305074|NCT01232283|E2|Reported Event|Apremilast: Weeks 0-16 (PBO-Controlled Phase)|Participants randomized to apremilast 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16)
305075|NCT01232283|E1|Reported Event|Placebo: Weeks 0-16 (PBO-Controlled Phase)|Participants randomized to identically matching placebo tablets BID during the Placebo-controlled Phase (Weeks 0-16)
305076|NCT01232205|B3|Baseline|Total|Total of all reporting groups
305077|NCT01232205|B2|Baseline|Control|
305078|NCT01232205|B1|Baseline|Micronutrient Antioxidant|Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium
305079|NCT01232205|P2|Participant Flow|Control|
305080|NCT01232205|P1|Participant Flow|Micronutrient Antioxidant|Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium
305081|NCT01232205|O2|Outcome|Control|
305082|NCT01232205|O1|Outcome|Micronutrient Antioxidant|Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium
305083|NCT01232205|E2|Reported Event|Control|
305084|NCT01232205|E1|Reported Event|Micronutrient Antioxidant|Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium
305085|NCT01232127|B1|Baseline|All Treated|
305086|NCT01232127|P3|Participant Flow|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
305087|NCT01232127|P2|Participant Flow|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
305088|NCT01232127|P1|Participant Flow|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI). Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
305089|NCT01232127|O3|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
305090|NCT01232127|O2|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
305091|NCT01232127|O1|Outcome|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
305092|NCT01232127|O1|Outcome|All Treated|All participants who received at least 1 dose of atazanavir with ritonavir and tenofovir and with or without famotidine.
305093|NCT01232127|O3|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
305094|NCT01232127|O2|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
305095|NCT01232127|O1|Outcome|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
305096|NCT01232127|O3|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
305125|NCT01231984|O1|Outcome|4 mm Among Those in 12mm x 4mm Arm|Subjects randomized to this study arm first used the 12mm PN for 12 weeks, then switched to the 4mm PN for another 12 weeks.
305097|NCT01232127|O2|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
305098|NCT01232127|O1|Outcome|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg QD, plus TDF, 300 mg QD, and at least 1 NRTI on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
305099|NCT01232127|O3|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
305100|NCT01232127|O2|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg twice daily (BID) on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
305101|NCT01232127|O1|Outcome|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg once daily (QD), plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI)on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
305102|NCT01232127|O1|Outcome|All Treated|All participants who received at least 1 dose of atazanavir with ritonavir and tenofovir and with or without famotidine.
305103|NCT01232127|O3|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
305104|NCT01232127|O2|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
305105|NCT01232127|O1|Outcome|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
305106|NCT01232127|E3|Reported Event|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF
305107|NCT01232127|E2|Reported Event|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg twice daily (BID) on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
305108|NCT01232127|E1|Reported Event|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg once daily (QD), plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
305109|NCT01231984|B3|Baseline|Total|Total of all reporting groups
305110|NCT01231984|B2|Baseline|4 mm vs. 12.7 mm|Subjects randomized to this study arm first use either the 4mm PN or the 12.7mm PN for 12 weeks, then switch to the alternate PN for another 12 weeks. Order of PN use is randomly determined.
305111|NCT01231984|B1|Baseline|4 mm vs. 8 mm|Subjects randomized to this study arm first use either the 4mm PN or the 8mm PN for 12 weeks, then switched to the alternate PN for another 12 weeks. Order of PN use is randomly determined.
305112|NCT01231984|P4|Participant Flow|12.7 mm First ( 4 vs.12.7)|Subjects randomized to this sequence used the 12.7 mm PN for the first 12 weeks (Period 1), then switched to the 4 mm PN for the next 12 weeks (Period 2).
305113|NCT01231984|P3|Participant Flow|4 mm First (4 vs.12.7)|Subjects randomized to this sequence used the 4mm PN for the first 12 weeks (Period 1), then switched to the 12.7 mm PN for the next 12 weeks (Period 2).
305114|NCT01231984|P2|Participant Flow|8 mm First (4 vs.8)|Subjects randomized to this sequence used the 8mm PN for the first 12 weeks (Period 1), then switched to the 4 mm PN for the next 12 weeks (Period 2).
305115|NCT01231984|P1|Participant Flow|4 mm First (4 vs.8)|Subjects randomized to this sequence used the 4mm PN for the first 12 weeks (Period 1), then switched to the 8 mm PN for the next 12 weeks (Period 2).
305116|NCT01231984|O3|Outcome|12.7mm Needle|Number of subjects enrolled who were assigned to use the 12.7mm PN.
305117|NCT01231984|O2|Outcome|8mm Needle|Number of subjects enrolled who were assigned to use the 8mm PN.
305118|NCT01231984|O1|Outcome|4mm Needle|Number of subjects enrolled who were assigned to use the 4mm PN.
305119|NCT01231984|O2|Outcome|12.7 mm First (4 vs. 12.7)|Subjects randomized to this sequence used the 12.7 mm PN for the first 12 weeks (Period 1), then switched to the 4 mm PN for the next 12 weeks (Period 2).
305120|NCT01231984|O1|Outcome|4 mm First (4 vs. 12.7)|Subjects randomized to this sequence used the 4mm PN for the first 12 weeks (Period 1), then switched to the 12.7 mm PN for the next 12 weeks (Period 2).
305121|NCT01231984|O3|Outcome|12.7mm Needle|Number of subjects enrolled who were assigned to use the 12.7mm PN.
305122|NCT01231984|O2|Outcome|8mm Needle|Number of subjects enrolled who were assigned to use the 8mm PN.
305123|NCT01231984|O1|Outcome|4mm Needle|Number of subjects enrolled who were assigned to use the 4mm PN.
305124|NCT01231984|O2|Outcome|12 mm Among Those in 4 mm x 12 mm Arm|Subjects randomized to this study arm first used the 4mm PN for 12 weeks, then switched to the 12mm PN for another 12 weeks.
305126|NCT01231984|O2|Outcome|8 mm Among Those in 4mm x 8mm Arm|Subjects randomized to this study arm first used the 4mm PN for 12 weeks, then switched to the 8mm PN for another 12 weeks.
305127|NCT01231984|O1|Outcome|4 mm Among Those in 8mm x 4 mm Arm|Subjects randomized to this study arm first used the 8mm PN for 12 weeks, then switched to the 4mm PN for another 12 weeks.
305128|NCT01231984|O2|Outcome|Longer PN First (8mm or 12.7mm)|Subjects in this group first used one of the longer PNs (8 mm or 12 mm PN) for 12 weeks in Period 1, based on the randomization, then switched to the 4mm PN for another 12 weeks in Period 2.
305129|NCT01231984|O1|Outcome|4 mm First|Subjects in this group first used the 4 mm PN for 12 weeks in Period 1, then switched to a longer PN (8 mm or 12 mm PN) for another 12 weeks in Period 2, based on their randomization.
305130|NCT01231984|O2|Outcome|8 mm First (4 vs. 8)|Subjects randomized to this sequence used the 8mm PN for the first 12 weeks (Period 1), then switched to the 4 mm PN for the next 12 weeks (Period 2).
305131|NCT01231984|O1|Outcome|4 mm First (4 vs. 8)|Subjects randomized to this sequence used the 4mm PN for the first 12 weeks (Period 1), then switched to the 8 mm PN for the next 12 weeks (Period 2).
305132|NCT01231984|E3|Reported Event|12.7mm Needle|
305133|NCT01231984|E2|Reported Event|8mm Needle|
305134|NCT01231984|E1|Reported Event|4mm Needle|
305135|NCT01231841|B1|Baseline|rATG|Patients receive anti-thymocyte globulin IV daily over 4-24 hours on days 1-5. Beginning on day 6, patients receive oral cyclosporine twice daily for 6 months followed by a taper. Treatment continues in the absence of disease progression or unacceptable toxicity
305136|NCT01231841|P1|Participant Flow|Rabbit Antithymocyte Globulin (r-ATG/Thymoglobulin)|Patients received rabbit anti-thymocyte globulin IV daily over 4-24 hours on days 1-5 (3.5 mg/kg/day). Beginning on day 6, patients received oral cyclosporine twice daily (5 mg/kg/day) for a period of 6 months and then tapered.
305137|NCT01231841|O1|Outcome|Rabbit Antithymocyte Globulin (r-ATG/Thymoglobulin)|Patients received rabbit anti-thymocyte globulin IV daily over 4-24 hours on days 1-5 (3.5 mg/kg/day). Beginning on day 6, patients received oral cyclosporine twice daily (5 mg/kg/day) for a period of 6 months and then tapered.
305138|NCT01231841|E1|Reported Event|rATG|Patients receive anti-thymocyte globulin IV daily over 4-24 hours on days 1-5. Beginning on day 6, patients receive oral cyclosporine twice daily for 6 months followed by a taper. Treatment continues in the absence of disease progression or unacceptable toxicity
305139|NCT01231750|B3|Baseline|Total|Total of all reporting groups
305140|NCT01231750|B2|Baseline|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
305141|NCT01231750|B1|Baseline|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
305142|NCT01231750|P2|Participant Flow|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
305143|NCT01231750|P1|Participant Flow|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
305144|NCT01231750|O2|Outcome|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
305145|NCT01231750|O1|Outcome|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
305146|NCT01231750|O2|Outcome|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
305147|NCT01231750|O1|Outcome|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
305148|NCT01231750|O2|Outcome|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
305149|NCT01231750|O1|Outcome|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
305150|NCT01231750|O2|Outcome|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
305151|NCT01231750|O1|Outcome|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
305152|NCT01231750|O2|Outcome|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
305153|NCT01231750|O1|Outcome|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
305154|NCT01231750|O2|Outcome|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
305155|NCT01231750|O1|Outcome|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
305156|NCT01231750|E2|Reported Event|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
305157|NCT01231750|E1|Reported Event|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
305158|NCT01231646|B3|Baseline|Total|Total of all reporting groups
305159|NCT01231646|B2|Baseline|Valproate|Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine.
305160|NCT01231646|B1|Baseline|Lamotrigine|Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate.
305161|NCT01231646|P2|Participant Flow|Valproate|Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine.
305162|NCT01231646|P1|Participant Flow|Lamotrigine|Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate.
308161|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
305164|NCT01231646|O1|Outcome|Lamotrigine|Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate.
305165|NCT01231646|E2|Reported Event|Valproate|Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine.
305166|NCT01231646|E1|Reported Event|Lamotrigine|Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate.
305167|NCT01231633|B3|Baseline|Total|Total of all reporting groups
305168|NCT01231633|B2|Baseline|Group 2|"Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.~Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed."
305169|NCT01231633|B1|Baseline|Group 1|"Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.~Ozurdex: Ozurdex, 0.7mg dexamethasone~Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed."
305170|NCT01231633|P2|Participant Flow|Avastin Only|"Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.~Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed."
305171|NCT01231633|P1|Participant Flow|Ozurdex & Avastin|"Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.~Ozurdex: Ozurdex, 0.7mg dexamethasone~Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed."
305172|NCT01231633|O2|Outcome|Group 2|"Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.~Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed."
305173|NCT01231633|O1|Outcome|Group 1|"Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.~Ozurdex: Ozurdex, 0.7mg dexamethasone~Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed."
305174|NCT01231633|O2|Outcome|Avastin Only|"Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.~Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed."
305175|NCT01231633|O1|Outcome|Ozurdex & Avastin|"Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.~Ozurdex: Ozurdex, 0.7mg dexamethasone~Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed."
305176|NCT01231633|O2|Outcome|Group 2|"Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.~Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed."
305177|NCT01231633|O1|Outcome|Group 1|"Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.~Ozurdex: Ozurdex, 0.7mg dexamethasone~Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed."
305178|NCT01231633|E2|Reported Event|Group 2|"Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.~Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed."
305179|NCT01231633|E1|Reported Event|Group 1|"Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.~Ozurdex: Ozurdex, 0.7mg dexamethasone~Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed."
305180|NCT01231620|B4|Baseline|Total|Total of all reporting groups
305181|NCT01231620|B3|Baseline|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305182|NCT01231620|B2|Baseline|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305183|NCT01231620|B1|Baseline|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305184|NCT01231620|P3|Participant Flow|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305185|NCT01231620|P2|Participant Flow|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305186|NCT01231620|P1|Participant Flow|IV Zanamivir 300 mg|Participants >=16 years of age received intravenous (IV) zanamivir 300 milligrams (mg) twice daily, adjusted for renal function for 5–10 days.
305187|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305188|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305189|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305190|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305191|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305192|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305193|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305194|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305195|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305196|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305197|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305198|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305199|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305200|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305201|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305202|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305203|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305204|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305205|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305206|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305207|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305208|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305209|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305210|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305211|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305212|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305213|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305214|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305215|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305216|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305217|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305218|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305219|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305220|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305221|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305222|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305223|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305224|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305225|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305226|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305227|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305228|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305229|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305230|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305231|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305232|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305233|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305234|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305235|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305236|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305237|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305238|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305239|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305240|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305241|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305242|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305243|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305244|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305245|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305246|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305247|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305248|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305249|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305250|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305251|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305252|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305253|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305254|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305255|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305256|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305257|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305258|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305259|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305260|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305261|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305262|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305263|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305264|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305265|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305266|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305267|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305268|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305269|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305270|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305271|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305272|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305273|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305274|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305275|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305276|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305277|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305278|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305279|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305280|NCT01231620|O3|Outcome|Oral Oseltamivir 75 mg|Participants >=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5–10 days.
305281|NCT01231620|O2|Outcome|IV Zanamivir 600 mg|Participants >=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5–10 days
305282|NCT01231620|O1|Outcome|IV Zanamivir 300 mg|Participants >=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5–10 days.
305283|NCT01231620|E3|Reported Event|Oral Oseltamivir 75mg Twice Daily|75mg oral oseltamivir twice daily plus intravenous placebo zanamivir twice daily
305284|NCT01231620|E2|Reported Event|Intravenous (IV) Zanamivir 600mg Twice Daily|600mg of IV zanamivir infusion twice daily plus oral oseltamivir placebo twice daily
305285|NCT01231620|E1|Reported Event|Intravenous (IV) Zanamivir 300mg Twice Daily|300mg of IV zanamivir infusion twice daily plus oral oseltamivir placebo twice daily
305286|NCT01231607|B6|Baseline|Total|Total of all reporting groups
305287|NCT01231607|B5|Baseline|Placebo|Matching dutasteride placebo and finasteride placebo once daily
305288|NCT01231607|B4|Baseline|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily
305289|NCT01231607|B3|Baseline|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily
305290|NCT01231607|B2|Baseline|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily
305291|NCT01231607|B1|Baseline|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily
305292|NCT01231607|P5|Participant Flow|Placebo|Matching dutasteride placebo and finasteride placebo once daily
305293|NCT01231607|P4|Participant Flow|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily
305294|NCT01231607|P3|Participant Flow|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily
305295|NCT01231607|P2|Participant Flow|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily
305296|NCT01231607|P1|Participant Flow|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily
305297|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
305298|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305299|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305300|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305301|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
305302|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
305303|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305304|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305305|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305306|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
305307|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
305308|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305309|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305310|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305311|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
305312|NCT01231607|O3|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305313|NCT01231607|O2|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305314|NCT01231607|O1|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305315|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
305316|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305317|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305318|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305319|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
305320|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
305321|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305322|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305323|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305324|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
305325|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
305326|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305327|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305328|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305329|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
305330|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
305331|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305332|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305333|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305334|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
305335|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
305336|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305337|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305338|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305339|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
305340|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
305341|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305342|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305343|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305344|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
305345|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
305346|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305347|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305348|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305349|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
305350|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
305351|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305352|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305353|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305354|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
305355|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
305356|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
306047|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
305357|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305358|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305359|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
305360|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
305361|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305362|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305363|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305364|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
305365|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
305366|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305367|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305368|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305369|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
305370|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
305371|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305372|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305373|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305374|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
305375|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
305376|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305377|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305378|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
305379|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
305380|NCT01231607|E5|Reported Event|Placebo|Matching dutasteride placebo and finasteride placebo once daily
305381|NCT01231607|E4|Reported Event|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily
305382|NCT01231607|E3|Reported Event|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily
305383|NCT01231607|E2|Reported Event|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily
305384|NCT01231607|E1|Reported Event|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily
305385|NCT01231581|B3|Baseline|Total|Total of all reporting groups
305386|NCT01231581|B2|Baseline|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
305387|NCT01231581|B1|Baseline|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
305388|NCT01231581|P2|Participant Flow|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
305716|NCT01231412|B3|Baseline|Arm 0 (CSP and Sirolimus)|Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011
305389|NCT01231581|P1|Participant Flow|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
305390|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
305391|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
305392|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
305393|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
305394|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
305395|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
305396|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
305397|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
305398|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
305399|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
305400|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
305401|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
305402|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
308162|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
305403|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
305404|NCT01231581|E2|Reported Event|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
305405|NCT01231581|E1|Reported Event|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
305406|NCT01231555|B4|Baseline|Total|Total of all reporting groups
305407|NCT01231555|B3|Baseline|EFV 600 mg Once Daily|Eligible participants were planned to receive oral EFV 600 mg tablet once daily up to 48 weeks, however participants received EFV 600 mg tablet once daily up to 16 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305408|NCT01231555|B2|Baseline|GSK2248761 200 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 200 mg (2x100 mg) capsule once daily up to 48 weeks, however, participants received GSK2248761 200 mg oral capsule once daily up to 8 weeks due early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305409|NCT01231555|B1|Baseline|GSK2248761 100 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 100 mg capsule once daily and matching GSK2248761 Placebo capsule once daily up to 48 weeks, however, participants received GSK2248761 100 once daily and matching GSK2248761 Placebo capsule once daily up to 8 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305410|NCT01231555|P3|Participant Flow|EFV 600 mg Once Daily|Eligible participants were planned to receive oral Efavirenz (EFV) 600 mg tablet once daily up to 48 weeks, however participants received EFV 600 mg tablet once daily up to 16 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305411|NCT01231555|P2|Participant Flow|GSK2248761 200 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 200 mg (2x100 mg) capsule once daily up to 48 weeks, however, participants received GSK2248761 200 mg oral capsule once daily up to 8 weeks due early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305412|NCT01231555|P1|Participant Flow|GSK2248761 100 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 100 milligrams (mg) capsule once daily and matching GSK2248761 Placebo capsule once daily up to 48 weeks, however, participants received GSK2248761 100 mg once daily and matching GSK2248761 Placebo capsule once daily up to 8 weeks due to early termination. All participants received antiretroviral therapy (ART) of Tenofovir disoproxil fumarate/ Emtricitabine (TDF/FTC) 300 mg/200 mg or Abacavir/ Lamivudine (ABC/3TC) 600 mg/300 mg along with the study drug.
305413|NCT01231555|O3|Outcome|EFV 600 mg Once Daily|Eligible participants were planned to receive oral EFV 600 mg tablet once daily up to 48 weeks, however participants received EFV 600 mg tablet once daily up to 16 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305414|NCT01231555|O2|Outcome|GSK2248761 200 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 200 mg (2x100 mg) capsule once daily up to 48 weeks, however, participants received GSK2248761 200 mg oral capsule once daily up to 8 weeks due early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305415|NCT01231555|O1|Outcome|GSK2248761 100 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 100 mg capsule once daily and matching GSK2248761 Placebo capsule once daily up to 48 weeks, however, participants received GSK2248761 100 once daily and matching GSK2248761 Placebo capsule once daily up to 8 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305416|NCT01231555|O3|Outcome|EFV 600 mg Once Daily|Eligible participants were planned to receive oral EFV 600 mg tablet once daily up to 48 weeks, however participants received EFV 600 mg tablet once daily up to 16 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305417|NCT01231555|O2|Outcome|GSK2248761 200 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 200 mg (2x100 mg) capsule once daily up to 48 weeks, however, participants received GSK2248761 200 mg oral capsule once daily up to 8 weeks due early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305418|NCT01231555|O1|Outcome|GSK2248761 100 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 100 mg capsule once daily and matching GSK2248761 Placebo capsule once daily up to 48 weeks, however, participants received GSK2248761 100 once daily and matching GSK2248761 Placebo capsule once daily up to 8 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305419|NCT01231555|O3|Outcome|EFV 600 mg Once Daily|Eligible participants were planned to receive oral EFV 600 mg tablet once daily up to 48 weeks, however participants received EFV 600 mg tablet once daily up to 16 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305420|NCT01231555|O2|Outcome|GSK2248761 200 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 200 mg (2x100 mg) capsule once daily up to 48 weeks, however, participants received GSK2248761 200 mg oral capsule once daily up to 8 weeks due early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305421|NCT01231555|O1|Outcome|GSK2248761 100 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 100 mg capsule once daily and matching GSK2248761 Placebo capsule once daily up to 48 weeks, however, participants received GSK2248761 100 once daily and matching GSK2248761 Placebo capsule once daily up to 8 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305422|NCT01231555|O3|Outcome|EFV 600 mg Once Daily|Eligible participants were planned to receive oral EFV 600 mg tablet once daily up to 48 weeks, however participants received EFV 600 mg tablet once daily up to 16 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305423|NCT01231555|O2|Outcome|GSK2248761 200 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 200 mg (2x100 mg) capsule once daily up to 48 weeks, however, participants received GSK2248761 200 mg oral capsule once daily up to 8 weeks due early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305424|NCT01231555|O1|Outcome|GSK2248761 100 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 100 mg capsule once daily and matching GSK2248761 Placebo capsule once daily up to 48 weeks, however, participants received GSK2248761 100 once daily and matching GSK2248761 Placebo capsule once daily up to 8 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305425|NCT01231555|O3|Outcome|EFV 600 mg Once Daily|Eligible participants were planned to receive oral EFV 600 mg tablet once daily up to 48 weeks, however participants received EFV 600 mg tablet once daily up to 16 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305426|NCT01231555|O2|Outcome|GSK2248761 200 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 200 mg (2x100 mg) capsule once daily up to 48 weeks, however, participants received GSK2248761 200 mg oral capsule once daily up to 8 weeks due early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305427|NCT01231555|O1|Outcome|GSK2248761 100 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 100 mg capsule once daily and matching GSK2248761 Placebo capsule once daily up to 48 weeks, however, participants received GSK2248761 100 once daily and matching GSK2248761 Placebo capsule once daily up to 8 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305428|NCT01231555|O3|Outcome|EFV 600 mg Once Daily|Eligible participants were planned to receive oral EFV 600 mg tablet once daily up to 48 weeks, however participants received EFV 600 mg tablet once daily up to 16 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305429|NCT01231555|O2|Outcome|GSK2248761 200 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 200 mg (2x100 mg) capsule once daily up to 48 weeks, however, participants received GSK2248761 200 mg oral capsule once daily up to 8 weeks due early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305430|NCT01231555|O1|Outcome|GSK2248761 100 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 100 mg capsule once daily and matching GSK2248761 Placebo capsule once daily up to 48 weeks, however, participants received GSK2248761 100 once daily and matching GSK2248761 Placebo capsule once daily up to 8 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305431|NCT01231555|O3|Outcome|EFV 600 mg Once Daily|Eligible participants were planned to receive oral EFV 600 mg tablet once daily up to 48 weeks, however participants received EFV 600 mg tablet once daily up to 16 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305432|NCT01231555|O2|Outcome|GSK2248761 200 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 200 mg (2x100 mg) capsule once daily up to 48 weeks, however, participants received GSK2248761 200 mg oral capsule once daily up to 8 weeks due early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305433|NCT01231555|O1|Outcome|GSK2248761 100 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 100 mg capsule once daily and matching GSK2248761 Placebo capsule once daily up to 48 weeks, however, participants received GSK2248761 100 once daily and matching GSK2248761 Placebo capsule once daily up to 8 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305434|NCT01231555|O3|Outcome|EFV 600 mg Once Daily|Eligible participants were planned to receive oral EFV 600 mg tablet once daily up to 48 weeks, however participants received EFV 600 mg tablet once daily up to 16 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305435|NCT01231555|O2|Outcome|GSK2248761 200 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 200 mg (2x100 mg) capsule once daily up to 48 weeks, however, participants received GSK2248761 200 mg oral capsule once daily up to 8 weeks due early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305436|NCT01231555|O1|Outcome|GSK2248761 100 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 100 mg capsule once daily and matching GSK2248761 Placebo capsule once daily up to 48 weeks, however, participants received GSK2248761 100 once daily and matching GSK2248761 Placebo capsule once daily up to 8 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305437|NCT01231555|E3|Reported Event|EFV 600 mg Once Daily|Eligible participants were planned to receive oral EFV 600 mg tablet once daily up to 48 weeks, however participants received EFV 600 mg tablet once daily up to 16 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305438|NCT01231555|E2|Reported Event|GSK2248761 200 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 200 mg (2x100 mg) capsule once daily up to 48 weeks, however, participants received GSK2248761 200 mg oral capsule once daily up to 8 weeks due early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305731|NCT01231412|O3|Outcome|Arm 0 (CSP and Sirolimus)|Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011
305439|NCT01231555|E1|Reported Event|GSK2248761 100 mg Once Daily|Eligible participants were planned to receive oral GSK2248761 100 mg capsule once daily and matching GSK2248761 Placebo capsule once daily up to 48 weeks, however, participants received GSK2248761 100 once daily and matching GSK2248761 Placebo capsule once daily up to 8 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
305440|NCT01231516|B3|Baseline|Total|Total of all reporting groups
305441|NCT01231516|B2|Baseline|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
305442|NCT01231516|B1|Baseline|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
305443|NCT01231516|P2|Participant Flow|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
305444|NCT01231516|P1|Participant Flow|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
305445|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continued to have access to DTG in the Open-Label phase of the study.
305446|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
305447|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
305448|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
305449|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
305450|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
305451|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
305452|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
305453|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
305454|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
305455|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
305456|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
305457|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
305458|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
305459|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
305460|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
305461|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
305462|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
305463|NCT01231516|E2|Reported Event|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK continued to supply RAL in the Open-Label Phase until it was commercially available.
305464|NCT01231516|E1|Reported Event|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continued to have access to DTG in the Open-Label phase of the study.
305465|NCT01231503|B9|Baseline|Total|Total of all reporting groups
305466|NCT01231503|B8|Baseline|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305467|NCT01231503|B7|Baseline|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305468|NCT01231503|B6|Baseline|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of TritanrixHepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305469|NCT01231503|B5|Baseline|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305470|NCT01231503|B4|Baseline|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305471|NCT01231503|B3|Baseline|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305472|NCT01231503|B2|Baseline|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305473|NCT01231503|B1|Baseline|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305474|NCT01231503|P8|Participant Flow|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305475|NCT01231503|P7|Participant Flow|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305476|NCT01231503|P6|Participant Flow|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305477|NCT01231503|P5|Participant Flow|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305478|NCT01231503|P4|Participant Flow|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305818|NCT01230892|B2|Baseline|Atenolol|Atenolol: 100 mg PO qday
305819|NCT01230892|B1|Baseline|Nebivolol|Nebivolol: 10 mg PO qday
305479|NCT01231503|P3|Participant Flow|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305480|NCT01231503|P2|Participant Flow|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305481|NCT01231503|P1|Participant Flow|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305482|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305483|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305484|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305485|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305486|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305487|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305820|NCT01230892|P2|Participant Flow|Atenolol|Atenolol: 100 mg PO qday
305821|NCT01230892|P1|Participant Flow|Nebivolol|Nebivolol: 10 mg PO qday
305488|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305489|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305490|NCT01231503|O5|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305491|NCT01231503|O4|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305492|NCT01231503|O3|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305493|NCT01231503|O2|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305494|NCT01231503|O1|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305495|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305496|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305822|NCT01230892|O2|Outcome|Atenolol|Atenolol: 100 mg PO qday
305823|NCT01230892|O1|Outcome|Nebivolol|Nebivolol: 10 mg PO qday
305497|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305498|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305499|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305500|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305501|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305502|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305503|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305504|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305505|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305824|NCT01230892|E2|Reported Event|Atenolol|Atenolol: 100 mg PO qday
305825|NCT01230892|E1|Reported Event|Nebivolol|Nebivolol: 10 mg PO qday
305506|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305507|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305508|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305509|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305510|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305511|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305512|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305513|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305514|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305826|NCT01230827|B5|Baseline|Total|Total of all reporting groups
305515|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305516|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305517|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305518|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305519|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305520|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305521|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305522|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305523|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305827|NCT01230827|B4|Baseline|Group IV: Golimumab + MTX|Participants were treated with golimumab 30 mg/m^2 through Week 12 and who were treated with golimumab 30 mg/m^2 + MTX at Week 16 and continued on golimumab 30 mg/m^2 + MTX through Week 48.
305524|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305525|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305526|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305527|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305528|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305529|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305530|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305531|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305532|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305843|NCT01230827|E4|Reported Event|Group IV: Golimumab + MTX|Participants were treated with golimumab 30 mg/m^2 through Week 12 and who were treated with golimumab 30 mg/m^2 + MTX at Week 16 and continued on golimumab 30 mg/m^2 + MTX through Week 48.
305533|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305534|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305535|NCT01231503|O5|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305536|NCT01231503|O4|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305537|NCT01231503|O3|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305538|NCT01231503|O2|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305539|NCT01231503|O1|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305540|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305541|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305884|NCT01230749|O2|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
305542|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305543|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305544|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305545|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305546|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305547|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305548|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305549|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305550|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305885|NCT01230749|O1|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
305551|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305552|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305553|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305554|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305555|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305556|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305557|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305558|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305559|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305886|NCT01230749|O3|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
305560|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305561|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305562|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305563|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305564|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305565|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305566|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305567|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305568|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305887|NCT01230749|O2|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
305569|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305570|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305571|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305572|NCT01231503|O2|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305573|NCT01231503|O1|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305574|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305575|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305576|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305577|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305888|NCT01230749|O1|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
305578|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305579|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305580|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305581|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305582|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305583|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305584|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305585|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305586|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305889|NCT01230749|O3|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
308163|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
305587|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305588|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305589|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305590|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305591|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305592|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305593|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305594|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305595|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305890|NCT01230749|O2|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
305596|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305597|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305598|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305599|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305600|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305601|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305602|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305603|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305604|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305891|NCT01230749|O1|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
305605|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305606|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305607|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305608|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305609|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305610|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305611|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305612|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305613|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305892|NCT01230749|O4|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
305614|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305615|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305616|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305617|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305618|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305619|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305620|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305621|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305622|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305893|NCT01230749|O3|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
305623|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305624|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305625|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305626|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305627|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305628|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305629|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305630|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305631|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305894|NCT01230749|O2|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
305632|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305633|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305634|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305635|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305636|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305637|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305638|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305639|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305640|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305895|NCT01230749|O1|Outcome|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
305641|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305642|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305643|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305644|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305645|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305646|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305647|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305648|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305649|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305896|NCT01230749|O4|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
305650|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305651|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305652|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305653|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305654|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305655|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305656|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305657|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305658|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305897|NCT01230749|O3|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
305659|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305660|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305661|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305662|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305663|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305664|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305665|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305666|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305667|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305898|NCT01230749|O2|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
308164|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
305668|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305669|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305670|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305671|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305672|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305673|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305674|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305675|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305676|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305899|NCT01230749|O1|Outcome|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
305677|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305678|NCT01231503|O1|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305679|NCT01231503|O4|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305680|NCT01231503|O3|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305681|NCT01231503|O2|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305682|NCT01231503|O1|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305683|NCT01231503|O3|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305684|NCT01231503|O2|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305685|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305900|NCT01230749|O4|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
305686|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305687|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305688|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305689|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305690|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305691|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305692|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305693|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305694|NCT01231503|E8|Reported Event|Engerix-B Neo Group|Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305901|NCT01230749|O3|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
305695|NCT01231503|E7|Reported Event|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305696|NCT01231503|E6|Reported Event|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305697|NCT01231503|E5|Reported Event|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305698|NCT01231503|E4|Reported Event|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305699|NCT01231503|E3|Reported Event|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305700|NCT01231503|E2|Reported Event|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305701|NCT01231503|E1|Reported Event|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
305702|NCT01231464|B3|Baseline|Total|Total of all reporting groups
305703|NCT01231464|B2|Baseline|Placebo|Matching Vehicle Placebo Nasal Spray QD
305704|NCT01231464|B1|Baseline|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)
305705|NCT01231464|P2|Participant Flow|Placebo|Matching Vehicle Placebo Nasal Spray QD
305706|NCT01231464|P1|Participant Flow|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)
305707|NCT01231464|O2|Outcome|Placebo|Matching Vehicle Placebo Nasal Spray QD
305708|NCT01231464|O1|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mg) once daily (QD)
305709|NCT01231464|O2|Outcome|Placebo|Matching Vehicle placebo nasal spray QD
305710|NCT01231464|O1|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)
305711|NCT01231464|O2|Outcome|Placebo|Matching Vehicle Placebo Nasal Spray QD
305712|NCT01231464|O1|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)
305713|NCT01231464|E2|Reported Event|Placebo|Matching Vehicle Placebo Nasal Spray QD
305714|NCT01231464|E1|Reported Event|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)
305715|NCT01231412|B4|Baseline|Total|Total of all reporting groups
305902|NCT01230749|O2|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
305717|NCT01231412|B2|Baseline|Arm II (MMF, CSP, and Sirolimus)|"Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT~Sirolimus: Given PO~Total-Body Irradiation: Undergo TBI"
305718|NCT01231412|B1|Baseline|Arm I (MMF and CSP)|"Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT~Total-Body Irradiation: Undergo TBI"
305719|NCT01231412|P3|Participant Flow|Arm 0 (CSP and Sirolimus)|Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011
305720|NCT01231412|P2|Participant Flow|Arm II (MMF, CSP, and Sirolimus)|"Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT~Sirolimus: Given PO~Total-Body Irradiation: Undergo TBI"
305721|NCT01231412|P1|Participant Flow|Arm I (MMF and CSP)|"Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT~Total-Body Irradiation: Undergo TBI"
305722|NCT01231412|O3|Outcome|Arm 0 (CSP and Sirolimus)|Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011
305723|NCT01231412|O2|Outcome|Arm II (MMF, CSP, and Sirolimus)|"Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT~Sirolimus: Given PO~Total-Body Irradiation: Undergo TBI"
305724|NCT01231412|O1|Outcome|Arm I (MMF and CSP)|"Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT~Total-Body Irradiation: Undergo TBI"
305725|NCT01231412|O3|Outcome|Arm 0 (CSP and Sirolimus)|Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011
305726|NCT01231412|O2|Outcome|Arm II (MMF, CSP, and Sirolimus)|"Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT~Sirolimus: Given PO~Total-Body Irradiation: Undergo TBI"
305727|NCT01231412|O1|Outcome|Arm I (MMF and CSP)|"Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT~Total-Body Irradiation: Undergo TBI"
305728|NCT01231412|O3|Outcome|Arm 0 (CSP and Sirolimus)|Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011
305729|NCT01231412|O2|Outcome|Arm II (MMF, CSP, and Sirolimus)|"Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT~Sirolimus: Given PO~Total-Body Irradiation: Undergo TBI"
305730|NCT01231412|O1|Outcome|Arm I (MMF and CSP)|"Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT~Total-Body Irradiation: Undergo TBI"
305903|NCT01230749|O1|Outcome|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
305732|NCT01231412|O2|Outcome|Arm II (MMF, CSP, and Sirolimus)|"Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT~Sirolimus: Given PO~Total-Body Irradiation: Undergo TBI"
305733|NCT01231412|O1|Outcome|Arm I (MMF and CSP)|"Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT~Total-Body Irradiation: Undergo TBI"
305734|NCT01231412|O3|Outcome|Arm 0 (CSP and Sirolimus)|Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011
305735|NCT01231412|O2|Outcome|Arm II (MMF, CSP, and Sirolimus)|"Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT~Sirolimus: Given PO~Total-Body Irradiation: Undergo TBI"
305736|NCT01231412|O1|Outcome|Arm I (MMF and CSP)|"Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT~Total-Body Irradiation: Undergo TBI"
305737|NCT01231412|O3|Outcome|Arm 0 (CSP and Sirolimus)|Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011
305738|NCT01231412|O2|Outcome|Arm II (MMF, CSP, and Sirolimus)|"Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT~Sirolimus: Given PO~Total-Body Irradiation: Undergo TBI"
305739|NCT01231412|O1|Outcome|Arm I (MMF and CSP)|"Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT~Total-Body Irradiation: Undergo TBI"
305740|NCT01231412|E3|Reported Event|Arm 0 (CSP and Sirolimus)|Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011
305741|NCT01231412|E2|Reported Event|Arm II (MMF, CSP, and Sirolimus)|"Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT~Sirolimus: Given PO~Total-Body Irradiation: Undergo TBI"
305742|NCT01231412|E1|Reported Event|Arm I (MMF and CSP)|"Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT~Cyclosporine: Given PO or IV~Fludarabine Phosphate: Given IV~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT~Total-Body Irradiation: Undergo TBI"
305743|NCT01231399|B1|Baseline|Dose Level 1 - 2.5 mg Everolimus Daily|"Patients receive 400 mg/m^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m^2 leucovorin calcium IV over 2 hours, and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~everolimus: Given orally"
305744|NCT01231399|P1|Participant Flow|Dose Level 1 - 2.5 mg Everolimus Daily|"Patients receive 400 mg/m^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m^2 leucovorin calcium IV over 2 hours, and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~everolimus: Given orally"
305745|NCT01231399|O1|Outcome|Dose Level 1 - 2.5 mg Everolimus Daily|"Patients receive 400 mg/m^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m^2 leucovorin calcium IV over 2 hours, and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~everolimus: Given orally"
305746|NCT01231399|O1|Outcome|Dose Level 1 - 2.5 mg Everolimus Daily|"Patients receive 400 mg/m^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m^2 leucovorin calcium IV over 2 hours, and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~everolimus: Given orally"
305747|NCT01231399|O1|Outcome|Dose Level 1 - 2.5 mg Everolimus Daily|"Patients receive 400 mg/m^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m^2 leucovorin calcium IV over 2 hours, and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~everolimus: Given orally"
305748|NCT01231399|O1|Outcome|Dose Level 1 - 2.5 mg Everolimus|"Patients receive 400 mg/m^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m^2 leucovorin calcium IV over 2 hours, and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~everolimus: Given orally"
305749|NCT01231399|E1|Reported Event|Dose Level 1 - 2.5 mg Everolimus Daily|"Patients receive 400 mg/m^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m^2 leucovorin calcium IV over 2 hours, and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~everolimus: Given orally"
305750|NCT01231373|B5|Baseline|Total|Total of all reporting groups
305751|NCT01231373|B4|Baseline|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam therapeutic dose
305752|NCT01231373|B3|Baseline|Polidocanol Injectable Foam, 0.5%|polidocanol injectable foam lower experimental dose
305753|NCT01231373|B2|Baseline|Polidocanol Injectable Foam, 0.125%|polidocanol injectable foam active placebo
305754|NCT01231373|B1|Baseline|Vehicle|Vehicle: Injection of vehicle comparator
305755|NCT01231373|P4|Participant Flow|Polidocanol Injectable Foam, 1.0%|1.0% polidocanol foam injection
305756|NCT01231373|P3|Participant Flow|Polidocanol Injectable Foam, 0.5%|lower experimental polidocanol dose
305757|NCT01231373|P2|Participant Flow|Polidocanol Injectable Foam, 0.125%|active placebo for blinding of therapeutic polidocanol dose
305758|NCT01231373|P1|Participant Flow|Vehicle|Vehicle: Injection of vehicle comparator
305759|NCT01231373|O4|Outcome|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam, 1.0% experimental dose
305760|NCT01231373|O3|Outcome|Polidocanol Injectable Foam, 0.5%|experimental dose polidocanol injectable foam, 0.5%
305761|NCT01231373|O2|Outcome|Polidocanol Injectable Foam, 0.125%|polidocanol injectable foam, 0.125%: active placebo for blinding
305762|NCT01231373|O1|Outcome|Vehicle|Vehicle: Injection of vehicle comparator
305763|NCT01231373|O4|Outcome|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam, experimental dose 1.0%
305764|NCT01231373|O3|Outcome|Polidocanol Injectable Foam, 0.5%|experimental dose polidocanol injectable foam, 0.5%
305765|NCT01231373|O2|Outcome|Polidocanol Injectable Foam, 0.125%|polidocanol injectable foam, 0.125%: active placebo for blinding
305766|NCT01231373|O1|Outcome|Vehicle|Vehicle: Injection of vehicle comparator
305767|NCT01231373|O4|Outcome|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam, 1.0%: Injection of mid-dose PEM
305768|NCT01231373|O3|Outcome|Polidocanol Injectable Foam, 0.5%|experimental dose polidocanol injectable foam, 0.5%
305769|NCT01231373|O2|Outcome|Polidocanol Injectable Foam, 0.125%|polidocanol injectable foam, 0.125%: active placebo for blinding
305770|NCT01231373|O1|Outcome|Vehicle|Vehicle: Injection of vehicle comparator
305771|NCT01231373|E4|Reported Event|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam target therapeutic dose
305772|NCT01231373|E3|Reported Event|Polidocanol Injectable Foam, 0.5%|polidocanol injectable foam, 0.5% lower experimental dose
305773|NCT01231373|E2|Reported Event|Polidocanol Injectable Foam, 0.125%|polidocanol injectable foam, 0.125% active placebo
305774|NCT01231373|E1|Reported Event|Vehicle|Vehicle: Injection of vehicle comparator
305775|NCT01231334|B3|Baseline|Total|Total of all reporting groups
305776|NCT01231334|B2|Baseline|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
305777|NCT01231334|B1|Baseline|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
305778|NCT01231334|P2|Participant Flow|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
305779|NCT01231334|P1|Participant Flow|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
305780|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
305781|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
305782|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
305783|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
305784|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
305785|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
305786|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
305787|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
305788|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
305789|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
305790|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
305791|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
305792|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
305793|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
305794|NCT01231334|E2|Reported Event|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
305795|NCT01231334|E1|Reported Event|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
305796|NCT01231321|B1|Baseline|Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL|Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.
305797|NCT01231321|P1|Participant Flow|Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL|Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.
305798|NCT01231321|O1|Outcome|Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL|Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.
305799|NCT01231321|O2|Outcome|Above Reference Range|Subjects with vital sign values at Week 24 higher than the reference range indicated for each parameter
305800|NCT01231321|O1|Outcome|Below Reference Range|Subjects with vital sign values at Week 24 lower than the reference range indicated for each parameter
305801|NCT01231321|O2|Outcome|Above Reference Range|Subjects with laboratory values at Week 24 higher than the reference range indicated for each parameter
305802|NCT01231321|O1|Outcome|Below Reference Range|Subjects with laboratory values at Week 24 lower than the reference range indicated for each parameter
305803|NCT01231321|O2|Outcome|Change From Abnormal to Normal|Subjects whose physical examination findings for the categories below were abnormal at Baseline and normal at 24 weeks
305804|NCT01231321|O1|Outcome|Change From Normal to Abnormal|Subjects whose physical examination findings for the categories below were normal at Baseline and abnormal at 24 weeks
305805|NCT01231321|O1|Outcome|Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL|Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.
305806|NCT01231321|E1|Reported Event|Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL|Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.
305807|NCT01231230|B1|Baseline|All Study Participants|participant received in random order one of the four treatments ( fluticasone, salmeterol, fluticasone+salmeterol or placebo)
305808|NCT01231230|P1|Participant Flow|All Study Groups|"inhalation of 250 mcg of fluticasone~fluticasone: 220- mcg once"
305809|NCT01231230|O4|Outcome|Fluticasone/Salmeterol|"inhalation of fluticasone 250mcg combined with salmeterol 50 mcg~fluticasone/salmeterol: inhalation of 250 mcg of fluticasone combined with 50 mcg of salmeterol"
305810|NCT01231230|O3|Outcome|Salmeterol|"inhalation of salmeterol 50 mcg once~Salmeterol: 50 mcg salmeterol once~Salmeterol: 50 mcg once"
305811|NCT01231230|O2|Outcome|Placebo|"inhalation of placebo diskus~placebo inhalation: placebo inhalation once"
305812|NCT01231230|O1|Outcome|Fluticasone|"inhalation of 250 mcg of fluticasone~fluticasone: 220- mcg once"
305813|NCT01231230|E4|Reported Event|Fluticasone/Salmeterol|"inhalation of fluticasone 250mcg combined with salmeterol 50 mcg~fluticasone/salmeterol: inhalation of 250 mcg of fluticasone combined with 50 mcg of salmeterol"
305814|NCT01231230|E3|Reported Event|Salmeterol|"inhalation of salmeterol 50 mcg once~Salmeterol: 50 mcg salmeterol once~Salmeterol: 50 mcg once"
305815|NCT01231230|E2|Reported Event|Placebo|"inhalation of placebo diskus~placebo inhalation: placebo inhalation once"
305816|NCT01231230|E1|Reported Event|Fluticasone|"inhalation of 250 mcg of fluticasone~fluticasone: 220- mcg once"
305817|NCT01230892|B3|Baseline|Total|Total of all reporting groups
305828|NCT01230827|B3|Baseline|Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX|Participants who were treated with golimumab 30 mg/m^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48. Adverse events are reported for participants who switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48.
305829|NCT01230827|B2|Baseline|Group II: Placebo Subcutaneously (SC) + MTX|Participants who were treated with golimumab 30 milligram per square meter (mg/m^2) through Week 12 and were treated with placebo + Methotrexate (MTX) at Week 16 and continued on placebo + MTX through Week 48.
305830|NCT01230827|B1|Baseline|Group I: Participants Who Did Not Enter RW Period|Enrolled participants who did not enter randomized withdrawal (RW) period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an American College of Rheumatology [ACR] Ped 30 response) at Week 16.
305831|NCT01230827|P4|Participant Flow|Group IV: Golimumab + MTX|Participants were treated with golimumab 30 mg/m^2 through Week 12 and who were treated with golimumab 30 mg/m^2 + MTX at Week 16 and continued on golimumab 30 mg/m^2 + MTX through Week 48.
305832|NCT01230827|P3|Participant Flow|Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX|Participants who were treated with golimumab 30 mg/m^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48. Adverse events are reported for participants who switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48.
305833|NCT01230827|P2|Participant Flow|Group II: Placebo Subcutaneously (SC) + MTX|Participants who were treated with golimumab 30 milligram per square meter (mg/m^2) through Week 12 and were treated with placebo + Methotrexate (MTX) at Week 16 and continued on placebo + MTX through Week 48.
305834|NCT01230827|P1|Participant Flow|Group I: Participants Who Did Not Enter RW Period|Enrolled participants who did not enter randomized withdrawal (RW) period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an American College of Rheumatology [ACR] Ped 30 response) at Week 16.
305835|NCT01230827|O2|Outcome|CNTO 148 (Golimumab)|Participants received golimumab 30 milligram per square meter (mg/m^2) every 4 weeks from Week 0 through Week 12. Participants who had a clinical response at Week 16 and who were randomly allocated to golimumab, received 30 mg/m^2 every 4 weeks through Week 48. Participants continued receiving golimumab 30 mg/m^2 after Week 48 in a long-term extension until Week 248. All participants received their fixed dose of commercial methotrexate throughout the study duration.
305836|NCT01230827|O1|Outcome|Placebo|Participants received golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Participants who had a clinical response to golimumab at Week 16 and were randomly allocated to placebo, received placebo every 4 weeks through Week 48. However, participants receiving placebo and had flare received golimumab 30 mg/m^2 every 4 weeks through Week 48. At Week 48, participants who were receiving placebo not having a clinical remission switched to receive golimumab 30 mg/m^2 in a long-term extension until Week 248 and participants who were receiving placebo and had a clinical remission discontinued from the study. All participants received their fixed dose of commercial methotrexate throughout the study duration.
305837|NCT01230827|O2|Outcome|CNTO 148 (Golimumab)|Participants received golimumab 30 milligram per square meter (mg/m^2) every 4 weeks from Week 0 through Week 12. Participants who had a clinical response at Week 16 and who were randomly allocated to golimumab, received 30 mg/m^2 every 4 weeks through Week 48. Participants continued receiving golimumab 30 mg/m^2 after Week 48 in a long-term extension until Week 248. All participants received their fixed dose of commercial methotrexate throughout the study duration.
305838|NCT01230827|O1|Outcome|Placebo|Participants received golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Participants who had a clinical response to golimumab at Week 16 and were randomly allocated to placebo, received placebo every 4 weeks through Week 48. However, participants receiving placebo and had flare received golimumab 30 mg/m^2 every 4 weeks through Week 48. At Week 48, participants who were receiving placebo not having a clinical remission switched to receive golimumab 30 mg/m^2 in a long-term extension until Week 248 and participants who were receiving placebo and had a clinical remission discontinued from the study. All participants received their fixed dose of commercial methotrexate throughout the study duration.
305839|NCT01230827|O2|Outcome|CNTO 148 (Golimumab)|Participants received golimumab 30 milligram per square meter (mg/m^2) every 4 weeks from Week 0 through Week 12. Participants who had a clinical response at Week 16 and who were randomly allocated to golimumab, received 30 mg/m^2 every 4 weeks through Week 48. Participants continued receiving golimumab 30 mg/m^2 after Week 48 in a long-term extension until Week 248. All participants received their fixed dose of commercial methotrexate throughout the study duration.
305840|NCT01230827|O1|Outcome|Placebo|Participants received golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Participants who had a clinical response to golimumab at Week 16 and were randomly allocated to placebo, received placebo every 4 weeks through Week 48. However, participants receiving placebo and had flare received golimumab 30 mg/m^2 every 4 weeks through Week 48. At Week 48, participants who were receiving placebo not having a clinical remission switched to receive golimumab 30 mg/m^2 in a long-term extension until Week 248 and participants who were receiving placebo and had a clinical remission discontinued from the study. All participants received their fixed dose of commercial methotrexate throughout the study duration.
305841|NCT01230827|O2|Outcome|CNTO 148 (Golimumab)|Participants received golimumab 30 milligram per square meter (mg/m^2) every 4 weeks from Week 0 through Week 12. Participants who had a clinical response at Week 16 and who were randomly allocated to golimumab, received 30 mg/m^2 every 4 weeks through Week 48. Participants continued receiving golimumab 30 mg/m^2 after Week 48 in a long-term extension until Week 248. All participants received their fixed dose of commercial methotrexate throughout the study duration.
305842|NCT01230827|O1|Outcome|Placebo|Participants received golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Participants who had a clinical response to golimumab at Week 16 and were randomly allocated to placebo, received placebo every 4 weeks through Week 48. However, participants receiving placebo and had flare received golimumab 30 mg/m^2 every 4 weeks through Week 48. At Week 48, participants who were receiving placebo not having a clinical remission switched to receive golimumab 30 mg/m^2 in a long-term extension until Week 248 and participants who were receiving placebo and had a clinical remission discontinued from the study. All participants received their fixed dose of commercial methotrexate throughout the study duration.
305904|NCT01230749|O4|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
305844|NCT01230827|E3|Reported Event|Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX|Participants who were treated with golimumab 30 mg/m^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48. Adverse events are reported for participants who switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48.
305845|NCT01230827|E2|Reported Event|Group II: Placebo Subcutaneously (SC) + MTX|Participants who were treated with golimumab 30 milligram per square meter (mg/m^2) through Week 12 and were treated with placebo + Methotrexate (MTX) at Week 16 and continued on placebo + MTX through Week 48.
305846|NCT01230827|E1|Reported Event|Group I: Participants Who Did Not Enter RW Period|Enrolled participants who did not enter randomized withdrawal (RW) period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an American College of Rheumatology [ACR] Ped 30 response) at Week 16.
305847|NCT01230814|B3|Baseline|Total|Total of all reporting groups
305848|NCT01230814|B2|Baseline|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
305849|NCT01230814|B1|Baseline|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
305850|NCT01230814|P2|Participant Flow|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
305851|NCT01230814|P1|Participant Flow|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
305852|NCT01230814|O2|Outcome|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
305853|NCT01230814|O1|Outcome|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
305854|NCT01230814|O2|Outcome|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
305855|NCT01230814|O1|Outcome|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
305856|NCT01230814|O2|Outcome|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
305857|NCT01230814|O1|Outcome|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
305858|NCT01230814|O2|Outcome|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
305859|NCT01230814|O1|Outcome|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
305860|NCT01230814|E2|Reported Event|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
305861|NCT01230814|E1|Reported Event|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
305862|NCT01230788|B1|Baseline|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
305863|NCT01230788|P1|Participant Flow|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
305864|NCT01230788|O1|Outcome|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
305865|NCT01230788|O1|Outcome|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
305866|NCT01230788|O1|Outcome|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
305867|NCT01230788|O1|Outcome|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
305868|NCT01230788|O1|Outcome|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
305869|NCT01230788|E1|Reported Event|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
305870|NCT01230749|B5|Baseline|Total|Total of all reporting groups
305871|NCT01230749|B4|Baseline|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
305872|NCT01230749|B3|Baseline|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
305873|NCT01230749|B2|Baseline|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
305874|NCT01230749|B1|Baseline|Placebo|Participants received placebo tablets orally, twice a day for 29 days.
305875|NCT01230749|P4|Participant Flow|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
305876|NCT01230749|P3|Participant Flow|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
305877|NCT01230749|P2|Participant Flow|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
305878|NCT01230749|P1|Participant Flow|Placebo|Participants received placebo tablets orally, twice a day for 29 days.
305879|NCT01230749|O4|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
305880|NCT01230749|O3|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
305881|NCT01230749|O2|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
305882|NCT01230749|O1|Outcome|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
305883|NCT01230749|O3|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
305905|NCT01230749|O3|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
305906|NCT01230749|O2|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
305907|NCT01230749|O1|Outcome|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
305908|NCT01230749|E4|Reported Event|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
305909|NCT01230749|E3|Reported Event|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
305910|NCT01230749|E2|Reported Event|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
305911|NCT01230749|E1|Reported Event|Placebo|Participants received placebo tablets orally, twice a day for 29 days.
305912|NCT01230710|B1|Baseline|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
305913|NCT01230710|P1|Participant Flow|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
305914|NCT01230710|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
305915|NCT01230710|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
305916|NCT01230710|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
305917|NCT01230710|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
305918|NCT01230710|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
305919|NCT01230710|E1|Reported Event|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
305920|NCT01230502|B4|Baseline|Total|Total of all reporting groups
305921|NCT01230502|B3|Baseline|Group 1 Donor Specific Regulation (DSR) +, MPA Monotherapy|"Subjects that are DSR (donor specific regulation) positive and randomized (1:1)to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive~Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:~Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.~Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."
305922|NCT01230502|B2|Baseline|Group 2 Donor Specific Regulation DSR +; Standard of Care|"Subjects that are DSR (donor specific regulation) positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.~data and sample collection: Group 2 : DSR(+) standard of care:~These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"
305923|NCT01230502|B1|Baseline|Group 3: Donor Specific Regulation DSR -, Standard of Care|"Subjects who test DSR (donor specific regulation) negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.~data and sample collection: Group 3 : DSR(-) standard of care:~These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."
305924|NCT01230502|P3|Participant Flow|Group 1 Donor Specific Regulation (DSR) +, MPA Monotherapy|"Subjects that are Donor specific regulation (DSR) positive and randomized (1:1) to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive~Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:~Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.~Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."
305925|NCT01230502|P2|Participant Flow|Group 2 Donor Specific Regulation (DSR) +; Standard of Care|"Subjects that are DSR (donor specific regulation) positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.~data and sample collection: Group 2 : DSR (+)standard of care:~These subjects will be maintained on standard of care immunosuppression consisting of Tacrolimus and Mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"
305926|NCT01230502|P1|Participant Flow|Group 3: Donor Specific Regulation (DSR) -, Standard of Care|"Subjects who test Donor specific regulation (DSR) negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.~data and sample collection: Group 3 : DSR (-) standard of care:~These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."
305937|NCT01230424|B2|Baseline|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.~0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
305927|NCT01230502|O3|Outcome|Group 1 Donor Specific Regulation (DSR) +, MPA Monotherapy|"Subjects that are DSR positive and randomized (1:1) to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive~Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:~Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.~Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."
305928|NCT01230502|O2|Outcome|Group 2 Donor Specific Regulation (DSR) +; Standard of Care|"Subjects that are DSR positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.~data and sample collection: Group 2 : DSR (+)standard of care:~These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"
305929|NCT01230502|O1|Outcome|Group 3: Donor Specific Regulation (DSR) -, Standard of Care|"Subjects who test DSR negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.~data and sample collection: Group 3 : DSR (-) standard of care:~These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."
305930|NCT01230502|O3|Outcome|Group 1 DSR (+), Withdrawal of Tacrolimus to MPA Monotherapy|"Subjects that are DSR positive and randomized (1:1)to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive~Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:~Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.~Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."
305931|NCT01230502|O2|Outcome|Group 2 DSR (+); Standard of Care|"Subjects that are DSR positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.~data and sample collection: Group 2 : DSR (+)standard of care:~These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"
305932|NCT01230502|O1|Outcome|Group 3: DSR (-), Standard of Care|"Subjects who test DSR negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.~data and sample collection: Group 3 : DSR (-) standard of care:~These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."
305933|NCT01230502|E3|Reported Event|Group 1 DSR (Donor Specific Regulation) (+),MPA Monotherapy|"Subjects that are Donor specific regulation DSR positive and randomized (1:1) to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive~Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:~Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.~Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."
305934|NCT01230502|E2|Reported Event|Group 2 DSR (Donor Specific Regulation) (+); Standard of Care|"Subjects that are Donor specific regulation (DSR) positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.~data and sample collection: Group 2 : DSR(+) standard of care:~These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"
305935|NCT01230502|E1|Reported Event|Group 3: DSR (Donor Specific Regulation) (-), Standard of Care|"Subjects who test Donor specific regulation (DSR) negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.~data and sample collection: Group 3 : DSR(-) standard of care:~These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."
305936|NCT01230424|B3|Baseline|Total|Total of all reporting groups
306043|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
305938|NCT01230424|B1|Baseline|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.~Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
305939|NCT01230424|P2|Participant Flow|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.~0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
305940|NCT01230424|P1|Participant Flow|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.~Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
305941|NCT01230424|O2|Outcome|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.~0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
305942|NCT01230424|O1|Outcome|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.~Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
305943|NCT01230424|O2|Outcome|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.~0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
305944|NCT01230424|O1|Outcome|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.~Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
305945|NCT01230424|O2|Outcome|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.~0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
305946|NCT01230424|O1|Outcome|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.~Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
305947|NCT01230424|O2|Outcome|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.~0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
305948|NCT01230424|O1|Outcome|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.~Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
305949|NCT01230424|O2|Outcome|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.~0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
305950|NCT01230424|O1|Outcome|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.~Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
305951|NCT01230424|O2|Outcome|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.~0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
305952|NCT01230424|O1|Outcome|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.~Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
305953|NCT01230424|O2|Outcome|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.~0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
305954|NCT01230424|O1|Outcome|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.~Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
305955|NCT01230424|O2|Outcome|Sodium Chloride|"0.9% Sodium chloride injection as Placebo will be given into the study knee once every 12 weeks for a total of 8 injections.~0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
305956|NCT01230424|O1|Outcome|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.~Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
305957|NCT01230424|O2|Outcome|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.~0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
305958|NCT01230424|O1|Outcome|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.~Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
305959|NCT01230424|O2|Outcome|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.~0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
305960|NCT01230424|O1|Outcome|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.~Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
305961|NCT01230424|O2|Outcome|0.9% Sodium Chloride|All participants received 0.9% Sodium chloride injection given into the study knee once every 12 weeks for a total of 8 injections.
305962|NCT01230424|O1|Outcome|Triamcinolone Acetonide 40mg|All participants received 40 mg of triamcinolone acetonide into the study knee joint every 12 weeks for a total of 8 injections.
305963|NCT01230424|E2|Reported Event|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.~0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
305964|NCT01230424|E1|Reported Event|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.~Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
305965|NCT01230307|B3|Baseline|Total|Total of all reporting groups
308165|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
305966|NCT01230307|B2|Baseline|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.~Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
305967|NCT01230307|B1|Baseline|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months~Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
305968|NCT01230307|P2|Participant Flow|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.~Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
305969|NCT01230307|P1|Participant Flow|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months~Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
305970|NCT01230307|O2|Outcome|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.~Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
305971|NCT01230307|O1|Outcome|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months~Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
305972|NCT01230307|O2|Outcome|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.~Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
305973|NCT01230307|O1|Outcome|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months~Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
305974|NCT01230307|O2|Outcome|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.~Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
305975|NCT01230307|O1|Outcome|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months~Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
305976|NCT01230307|O2|Outcome|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.~Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
305977|NCT01230307|O1|Outcome|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months~Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
305978|NCT01230307|E2|Reported Event|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.~Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
305979|NCT01230307|E1|Reported Event|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months~Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
305980|NCT01230177|B1|Baseline|Etanercept (Renetical Recombination)|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
305981|NCT01230177|P1|Participant Flow|Etanercept（Genetial Recombination）|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
305982|NCT01230177|O1|Outcome|Etanercept（Genetial Recombination）|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
305983|NCT01230177|O1|Outcome|Etanercept（Genetial Recombination）|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
305984|NCT01230177|O1|Outcome|Etanercept（Genetial Recombination）|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
305985|NCT01230177|O1|Outcome|Etanercept（Genetial Recombination）|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
305986|NCT01230177|O1|Outcome|Etanercept（Genetial Recombination）|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
305987|NCT01230177|E1|Reported Event|Etanercept（Genetial Recombination）|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
305988|NCT01230060|B1|Baseline|enVista|"enVista One-Piece Hydrophobic Acrylic Intraocular Lens~enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery."
305989|NCT01230060|P1|Participant Flow|enVista|"enVista One-Piece Hydrophobic Acrylic Intraocular Lens~enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery."
305990|NCT01230060|O1|Outcome|enVista|"enVista One-Piece Hydrophobic Acrylic Intraocular Lens~enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery."
305991|NCT01230060|E1|Reported Event|enVista|"enVista One-Piece Hydrophobic Acrylic Intraocular Lens~enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery."
305992|NCT01230021|B1|Baseline|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
306044|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
305993|NCT01230021|P1|Participant Flow|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
305994|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
305995|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
305996|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
305997|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
305998|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
305999|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
306000|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
306001|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
306002|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
306003|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
306004|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
306005|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
306006|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
306007|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
306008|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
306009|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
306045|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
306046|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
306010|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
306011|NCT01230021|E1|Reported Event|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
306012|NCT01229943|B3|Baseline|Total|Total of all reporting groups
306013|NCT01229943|B2|Baseline|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15. >~> Bevacizumab: Given IV >~> Everolimus: Given PO >~> Octreotide Acetate: Given IM"
306014|NCT01229943|B1|Baseline|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1. > > Everolimus: Given PO >~> Octreotide Acetate: Given IM"
306015|NCT01229943|P2|Participant Flow|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15. >~> Bevacizumab: Given IV >~> Everolimus: Given PO >~> Octreotide Acetate: Given IM"
306016|NCT01229943|P1|Participant Flow|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1. > > Everolimus: Given PO >~> Octreotide Acetate: Given IM"
306017|NCT01229943|O2|Outcome|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15.~Bevacizumab: Given IV~Everolimus: Given PO~Octreotide Acetate: Given IM"
306018|NCT01229943|O1|Outcome|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1.~Everolimus: Given PO~Octreotide Acetate: Given IM"
306019|NCT01229943|O2|Outcome|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15.~Bevacizumab: Given IV~Everolimus: Given PO~Octreotide Acetate: Given IM"
306020|NCT01229943|O1|Outcome|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1.~Everolimus: Given PO~Octreotide Acetate: Given IM"
306021|NCT01229943|O2|Outcome|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15. >~> Bevacizumab: Given IV >~> Everolimus: Given PO >~> Octreotide Acetate: Given IM"
306022|NCT01229943|O1|Outcome|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1. > > Everolimus: Given PO >~> Octreotide Acetate: Given IM"
306023|NCT01229943|E2|Reported Event|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15.~Bevacizumab: Given IV~Everolimus: Given PO~Octreotide Acetate: Given IM"
306024|NCT01229943|E1|Reported Event|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1.~Everolimus: Given PO~Octreotide Acetate: Given IM"
306025|NCT01229891|B4|Baseline|Total|Total of all reporting groups
306026|NCT01229891|B3|Baseline|Vitamin D-calcium Yogurt Drink|daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL
306027|NCT01229891|B2|Baseline|Vitamin D-fortified Yogurt Drink|daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL
306028|NCT01229891|B1|Baseline|Plain Yogurt Drink|daily intake of two bottle (250 mL) plain yogurt drink
306029|NCT01229891|P3|Participant Flow|Vitamin D-calcium Yogurt Drink|daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL
306030|NCT01229891|P2|Participant Flow|Vitamin D-fortified Yogurt Drink|daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL
306031|NCT01229891|P1|Participant Flow|Plain Yogurt Drink|daily intake of two bottle (250 mL) plain yogurt drink
306032|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
306033|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
306034|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
306035|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
306036|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
306037|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
306038|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
306039|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
306040|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
306041|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
306042|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
306048|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
306049|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
306050|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
306051|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
306052|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
306053|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
306054|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
306055|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
306056|NCT01229891|E3|Reported Event|Vitamin D-calcium Yogurt Drink|daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL
306057|NCT01229891|E2|Reported Event|Vitamin D-fortified Yogurt Drink|daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL
306058|NCT01229891|E1|Reported Event|Plain Yogurt Drink|daily intake of two bottle (250 mL) plain yogurt drink
306059|NCT01229735|B3|Baseline|Total Title|
306060|NCT01229735|B2|Baseline|Topiramate|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
306061|NCT01229735|B1|Baseline|Levetiracetam|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
306062|NCT01229735|P2|Participant Flow|Topiramate|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
306063|NCT01229735|P1|Participant Flow|Levetiracetam|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
306064|NCT01229735|O2|Outcome|Topiramate (Full Analysis Set)|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
306065|NCT01229735|O1|Outcome|Levetiracetam (Full Analysis Set)|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
306066|NCT01229735|O2|Outcome|Topiramate (Full Analysis Set)|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
306067|NCT01229735|O1|Outcome|Levetiracetam (Full Analysis Set)|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
306068|NCT01229735|O2|Outcome|Topiramate|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
306069|NCT01229735|O1|Outcome|Levetiracetam|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
306070|NCT01229735|O2|Outcome|Topiramate|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
306071|NCT01229735|O1|Outcome|Levetiracetam|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
306072|NCT01229735|O2|Outcome|Topiramate (Full Analysis Set)|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
306073|NCT01229735|O1|Outcome|Levetiracetam (Full Analysis Set)|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
306074|NCT01229735|E2|Reported Event|Topiramate|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
306075|NCT01229735|E1|Reported Event|Levetiracetam|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
306076|NCT01229722|B3|Baseline|Total|Total of all reporting groups
306077|NCT01229722|B2|Baseline|Cell Phone|"Participants will receive a text message reminder at scheduled intervals, with varying frequency. They will also be subject to a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates may receive a call from a counselor.~ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module."
306078|NCT01229722|B1|Baseline|Beeper|Patients randomized to the control arm (Beeper) will receive the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects will simply asked to bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They will not receive any text messages addressing their adherence to ART between each study visit. Their providers will not be receiving any adherence reports but will be asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
306106|NCT01229462|O2|Outcome|Alphagan® and Timolol Concurrent|One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
306107|NCT01229462|O1|Outcome|Combigan®|One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
306079|NCT01229722|P2|Participant Flow|Cell Phone|"Participants will receive a text message reminder at scheduled intervals, with varying frequency. They will also be subject to a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates may receive a call from a counselor.~ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module."
306080|NCT01229722|P1|Participant Flow|Beeper|Patients randomized to the control arm (Beeper) will receive the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects will simply asked to bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They will not receive any text messages addressing their adherence to ART between each study visit. Their providers will not be receiving any adherence reports but will be asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
306081|NCT01229722|O2|Outcome|Cell Phone|"Participants will receive a text message reminder at scheduled intervals, with varying frequency. They will also be subject to a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates may receive a call from a counselor.~ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module."
306082|NCT01229722|O1|Outcome|Beeper|Patients randomized to the control arm (Beeper) will receive the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects will simply asked to bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They will not receive any text messages addressing their adherence to ART between each study visit. Their providers will not be receiving any adherence reports but will be asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
306083|NCT01229722|E2|Reported Event|Cell Phone|"Participants will receive a text message reminder at scheduled intervals, with varying frequency. They will also be subject to a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates may receive a call from a counselor.~ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module."
306084|NCT01229722|E1|Reported Event|Beeper|Patients randomized to the control arm (Beeper) will receive the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects will simply asked to bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They will not receive any text messages addressing their adherence to ART between each study visit. Their providers will not be receiving any adherence reports but will be asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
306085|NCT01229527|B4|Baseline|Total|Total of all reporting groups
306086|NCT01229527|B3|Baseline|Meperidine|
306087|NCT01229527|B2|Baseline|Remifentanil RS2|
306088|NCT01229527|B1|Baseline|Remifentanil RS1|
306089|NCT01229527|P3|Participant Flow|Meperidine|
306090|NCT01229527|P2|Participant Flow|Remifentanil RS2|
306091|NCT01229527|P1|Participant Flow|Remifentanil RS1|
306092|NCT01229527|O3|Outcome|Meperidine|
306093|NCT01229527|O2|Outcome|Remifentanil RS2|
306094|NCT01229527|O1|Outcome|Remifentanil RS1|
306095|NCT01229527|O3|Outcome|Meperidine|
306096|NCT01229527|O2|Outcome|Remifentanil RS2|
306097|NCT01229527|O1|Outcome|Remifentanil RS1|
306098|NCT01229527|E3|Reported Event|Meperidine|
306099|NCT01229527|E2|Reported Event|Remifentanil RS2|
306100|NCT01229527|E1|Reported Event|Remifentanil RS1|
306101|NCT01229462|B3|Baseline|Total|Total of all reporting groups
306102|NCT01229462|B2|Baseline|Alphagan® and Timolol Concurrent|One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
306103|NCT01229462|B1|Baseline|Combigan®|One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
306104|NCT01229462|P2|Participant Flow|Alphagan® and Timolol Concurrent|One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
306105|NCT01229462|P1|Participant Flow|Combigan®|One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
308166|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
306108|NCT01229462|E2|Reported Event|Alphagan® and Timolol Concurrent|One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
306109|NCT01229462|E1|Reported Event|Combigan®|One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
306110|NCT01229436|B1|Baseline|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306111|NCT01229436|P1|Participant Flow|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306112|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306113|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306114|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306115|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306116|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306117|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306118|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306119|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306120|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306121|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306122|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306123|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306252|NCT01229176|B8|Baseline|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
306124|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306125|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306126|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306127|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306128|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306129|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306130|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306131|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306132|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306133|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306134|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306135|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306136|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306137|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306138|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306168|NCT01229410|E2|Reported Event|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
306139|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306140|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306141|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306142|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306143|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306144|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306145|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306146|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306147|NCT01229436|E1|Reported Event|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
306148|NCT01229423|B1|Baseline|LATISSE®|bimatoprost 0.03% (LATISSE®)
306149|NCT01229423|P1|Participant Flow|LATISSE®|bimatoprost 0.03% (LATISSE®)
306150|NCT01229423|O1|Outcome|LATISSE®|bimatoprost 0.03% (LATISSE®)
306151|NCT01229423|O1|Outcome|LATISSE®|bimatoprost 0.03% (LATISSE®)
306152|NCT01229423|O1|Outcome|LATISSE®|bimatoprost 0.03% (LATISSE®)
306153|NCT01229423|O1|Outcome|LATISSE®|bimatoprost 0.03% (LATISSE®)
306154|NCT01229423|O1|Outcome|LATISSE®|bimatoprost 0.03% (LATISSE®)
306155|NCT01229423|O1|Outcome|LATISSE®|bimatoprost 0.03% (LATISSE®)
306156|NCT01229423|E1|Reported Event|LATISSE®|bimatoprost 0.03% (LATISSE®)
306157|NCT01229410|B3|Baseline|Total|Total of all reporting groups
306158|NCT01229410|B2|Baseline|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
306159|NCT01229410|B1|Baseline|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
306160|NCT01229410|P2|Participant Flow|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
306161|NCT01229410|P1|Participant Flow|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
306162|NCT01229410|O2|Outcome|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
306163|NCT01229410|O1|Outcome|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
306164|NCT01229410|O2|Outcome|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
306165|NCT01229410|O1|Outcome|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
306166|NCT01229410|O2|Outcome|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
306167|NCT01229410|O1|Outcome|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
306231|NCT01229228|B5|Baseline|Placebo|
306232|NCT01229228|B4|Baseline|Naprosyn 500 mg|
306233|NCT01229228|B3|Baseline|Naprosyn 250 mg|
306169|NCT01229410|E1|Reported Event|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
306170|NCT01229397|B3|Baseline|Total|Total of all reporting groups
306171|NCT01229397|B2|Baseline|Inflexal V 0.5 mL x 1|One 0.5 mL dose (on Day 1)
306172|NCT01229397|B1|Baseline|Inflexal V 0.25 mL x 2|Two 0.25 mL doses (on Day 1 and 29)
306173|NCT01229397|P2|Participant Flow|Inflexal V 0.5 mL x 1|"1 dose of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, containing per 0.5 mL dose:~15 μg HA antigen of A/California/7/2009 (H1N1)-like virus~15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus~15 μg HA antigen of B/Brisbane/60/2008-like virus"
306174|NCT01229397|P1|Participant Flow|Inflexal V 0.25 mL x 2|"2 doses of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, 4 weeks apart, containing per 0.25 mL dose:~7.5 μg HA antigen of A/California/7/2009 (H1N1)-like virus~7.5 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus~7.5 μg HA antigen of B/Brisbane/60/2008-like virus"
306175|NCT01229397|O2|Outcome|Inflexal V 0.5 mL x 1|One 0.5 mL dose (on Day 1)
306176|NCT01229397|O1|Outcome|Inflexal V 0.25 mL x 2|Two 0.25 mL doses (on Day 1 and 29)
306177|NCT01229397|O2|Outcome|Inflexal V 0.5 mL x 1|One 0.5 mL dose (on Day 1)
306178|NCT01229397|O1|Outcome|Inflexal V 0.25 mL x 2|Two 0.25 mL doses (on Day 1 and 29)
306179|NCT01229397|O3|Outcome|Inflexal V 0.5 mL x 1|
306180|NCT01229397|O2|Outcome|Inflexal V 0.25 mL x 2 - After 2nd Vaccination|
306181|NCT01229397|O1|Outcome|Inflexal V 0.25 mL x 2 - After 1st Vaccination|
306182|NCT01229397|O2|Outcome|Inflexal V 0.5 mL x 1|One 0.5 mL dose (on Day 1)
306183|NCT01229397|O1|Outcome|Inflexal V 0.25 mL x 2|Two 0.25 mL doses (on Day 1 and 29)
306184|NCT01229397|E3|Reported Event|Inflexal V 0.5 mL x 1|
306185|NCT01229397|E2|Reported Event|Inflexal V 0.25 mL x 2 - After 2nd Vaccination|
306186|NCT01229397|E1|Reported Event|Inflexal V 0.25 mL x 2 - After 1st Vaccination|
306187|NCT01229371|B5|Baseline|Total|Total of all reporting groups
306188|NCT01229371|B4|Baseline|Subjects >60 Years - CSL HA Antigen|
306189|NCT01229371|B3|Baseline|Subjects >60 Years - AdImmune HA Antigen|
306190|NCT01229371|B2|Baseline|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
306191|NCT01229371|B1|Baseline|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
306192|NCT01229371|P4|Participant Flow|Subjects >60 Years - CSL HA Antigen|
306193|NCT01229371|P3|Participant Flow|Subjects >60 Years - AdImmune HA Antigen|
306194|NCT01229371|P2|Participant Flow|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
306195|NCT01229371|P1|Participant Flow|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
306196|NCT01229371|O4|Outcome|Subjects >60 Years - CSL HA Antigen|
306197|NCT01229371|O3|Outcome|Subjects >60 Years - AdImmune HA Antigen|
306198|NCT01229371|O2|Outcome|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
306199|NCT01229371|O1|Outcome|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
306200|NCT01229371|O4|Outcome|Subjects >60 Years - CSL HA Antigen|
306201|NCT01229371|O3|Outcome|Subjects >60 Years - AdImmune HA Antigen|
306202|NCT01229371|O2|Outcome|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
306203|NCT01229371|O1|Outcome|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
306204|NCT01229371|O4|Outcome|Subjects >60 Years - CSL HA Antigen|
306205|NCT01229371|O3|Outcome|Subjects >60 Years - AdImmune HA Antigen|
306206|NCT01229371|O2|Outcome|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
306207|NCT01229371|O1|Outcome|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
306208|NCT01229371|O4|Outcome|Subjects >60 Years - CSL HA Antigen|
306209|NCT01229371|O3|Outcome|Subjects >60 Years - AdImmune HA Antigen|
306210|NCT01229371|O2|Outcome|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
306211|NCT01229371|O1|Outcome|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
306212|NCT01229371|E4|Reported Event|Subjects >60 Years - CSL HA Antigen|
306213|NCT01229371|E3|Reported Event|Subjects >60 Years - AdImmune HA Antigen|
306214|NCT01229371|E2|Reported Event|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
306215|NCT01229371|E1|Reported Event|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
306216|NCT01229254|B4|Baseline|Total|Total of all reporting groups
306217|NCT01229254|B3|Baseline|Betrixaban 90 mg (≥80 kg)|Betrixaban 90 mg once daily for at least 4 weeks and up to 24 weeks
306218|NCT01229254|B2|Baseline|Betrixaban 60 mg (<80 kg)|Betrixaban 60 mg once daily for at least 4 weeks and up to 24 weeks
306219|NCT01229254|B1|Baseline|Betrixaban 30 mg (+Amiodarone)|Betrixaban 30 mg once daily for at least 4 weeks and up to 24 weeks for patients taking amiodarone
306220|NCT01229254|P3|Participant Flow|Betrixaban 90 mg (≥80 kg)|Betrixaban 90 mg once daily for at least 4 weeks and up to 24 weeks
306221|NCT01229254|P2|Participant Flow|Betrixaban 60 mg (<80 kg)|Betrixaban 60 mg once daily for at least 4 weeks and up to 24 weeks
306222|NCT01229254|P1|Participant Flow|Betrixaban 30 mg (+Amiodarone)|Betrixaban 30 mg once daily for at least 4 weeks and up to 24 weeks for patients taking amiodarone
306223|NCT01229254|O1|Outcome|Betrixaban|Betrixaban 30 mg once daily for patients taking amiodarone, plus Betrixaban 60 mg once daily, plus Betrixaban 90 mg once daily, all for at least 4 weeks and up to 24 weeks
306224|NCT01229254|O3|Outcome|Betrixaban 90 mg (≥80 kg)|Betrixaban 90 mg once daily for at least 4 weeks and up to 24 weeks
306225|NCT01229254|O2|Outcome|Betrixaban 60 mg (<80 kg)|Betrixaban 60 mg once daily for at least 4 weeks and up to 24 weeks
306226|NCT01229254|O1|Outcome|Betrixaban 30 mg (+Amiodarone)|Betrixaban 30 mg once daily for at least 4 weeks and up to 24 weeks for patients taking amiodarone
306227|NCT01229254|E3|Reported Event|Betrixaban 90 mg (≥80 kg)|Betrixaban 90 mg once daily for at least 4 weeks and up to 24 weeks
306228|NCT01229254|E2|Reported Event|Betrixaban 60 mg (<80 kg)|Betrixaban 60 mg once daily for at least 4 weeks and up to 24 weeks
306229|NCT01229254|E1|Reported Event|Betrixaban 30 mg (+Amiodarone)|Betrixaban 30 mg once daily for at least 4 weeks and up to 24 weeks for patients taking amiodarone
306230|NCT01229228|B6|Baseline|Total|Total of all reporting groups
306253|NCT01229176|B7|Baseline|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
306254|NCT01229176|B6|Baseline|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
306255|NCT01229176|B5|Baseline|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
306256|NCT01229176|B4|Baseline|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
306257|NCT01229176|B3|Baseline|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
306258|NCT01229176|B2|Baseline|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
306259|NCT01229176|B1|Baseline|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
306260|NCT01229176|P8|Participant Flow|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
306261|NCT01229176|P7|Participant Flow|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
306262|NCT01229176|P6|Participant Flow|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
306263|NCT01229176|P5|Participant Flow|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
306264|NCT01229176|P4|Participant Flow|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
306265|NCT01229176|P3|Participant Flow|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
306266|NCT01229176|P2|Participant Flow|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
306267|NCT01229176|P1|Participant Flow|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
306268|NCT01229176|O8|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
306269|NCT01229176|O7|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
306270|NCT01229176|O6|Outcome|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
306271|NCT01229176|O5|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
306272|NCT01229176|O4|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
306273|NCT01229176|O3|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
306274|NCT01229176|O2|Outcome|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
306275|NCT01229176|O1|Outcome|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
306276|NCT01229176|O8|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
306277|NCT01229176|O7|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
306278|NCT01229176|O6|Outcome|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
306279|NCT01229176|O5|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
306280|NCT01229176|O4|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
306281|NCT01229176|O3|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
306282|NCT01229176|O2|Outcome|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
306283|NCT01229176|O1|Outcome|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
306284|NCT01229176|O8|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
306285|NCT01229176|O7|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
306286|NCT01229176|O6|Outcome|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
306287|NCT01229176|O5|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
306288|NCT01229176|O4|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
306289|NCT01229176|O3|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
306290|NCT01229176|O2|Outcome|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
306291|NCT01229176|O1|Outcome|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
306292|NCT01229176|O8|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
306293|NCT01229176|O7|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
306294|NCT01229176|O6|Outcome|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
306295|NCT01229176|O5|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
306296|NCT01229176|O4|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
306297|NCT01229176|O3|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
306298|NCT01229176|O2|Outcome|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
306299|NCT01229176|O1|Outcome|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
306300|NCT01229176|O8|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
306301|NCT01229176|O7|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
306302|NCT01229176|O6|Outcome|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
306303|NCT01229176|O5|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
308167|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
306304|NCT01229176|O4|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
306305|NCT01229176|O3|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
306306|NCT01229176|O2|Outcome|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
306307|NCT01229176|O1|Outcome|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
306308|NCT01229176|E8|Reported Event|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
306309|NCT01229176|E7|Reported Event|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
306310|NCT01229176|E6|Reported Event|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
306311|NCT01229176|E5|Reported Event|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
306312|NCT01229176|E4|Reported Event|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
306313|NCT01229176|E3|Reported Event|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
306314|NCT01229176|E2|Reported Event|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
306315|NCT01229176|E1|Reported Event|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
306316|NCT01229150|B5|Baseline|Total|Total of all reporting groups
306317|NCT01229150|B4|Baseline|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
306318|NCT01229150|B3|Baseline|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
306319|NCT01229150|B2|Baseline|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
306320|NCT01229150|B1|Baseline|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
306321|NCT01229150|P4|Participant Flow|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
306322|NCT01229150|P3|Participant Flow|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
306323|NCT01229150|P2|Participant Flow|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
306324|NCT01229150|P1|Participant Flow|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
306325|NCT01229150|O4|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
306326|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
306327|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
306328|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
306329|NCT01229150|O4|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erl (erlotinib) mg qd."
306330|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd (every day)"
306331|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
306332|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erl (erlotinib) mg qd."
306333|NCT01229150|O4|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
306334|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
306335|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
306336|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
306337|NCT01229150|O3|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
306338|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
306339|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
306340|NCT01229150|O3|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
306341|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
306342|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
306343|NCT01229150|O3|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
306344|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
306345|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
306346|NCT01229150|O3|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
306347|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
306348|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
306349|NCT01229150|O4|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
306350|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
306351|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
306352|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
306353|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
306354|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
306355|NCT01229150|O3|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
306356|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
306357|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
306358|NCT01229150|O4|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
306359|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
306360|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
306361|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
306362|NCT01229150|O4|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
306363|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
306364|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
306365|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
306366|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
306367|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
306368|NCT01229150|O1|Outcome|KRAS Mut 2 & WT KRAS 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS 2 patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
306369|NCT01229150|O4|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
306370|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
306371|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
306372|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
306373|NCT01229150|O4|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
306374|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
306375|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
306376|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
306377|NCT01229150|E3|Reported Event|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
306378|NCT01229150|E2|Reported Event|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
306379|NCT01229150|E1|Reported Event|KRAS Mut 2 & WT KRAS 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS 2 patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
306380|NCT01229111|B1|Baseline|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.~cediranib maleate: Given PO~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
306381|NCT01229111|P1|Participant Flow|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.~cediranib maleate: Given PO~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
306382|NCT01229111|O1|Outcome|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.~cediranib maleate: Given PO~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
306383|NCT01229111|O1|Outcome|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.~cediranib maleate: Given PO~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
306384|NCT01229111|O1|Outcome|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.~cediranib maleate: Given PO~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
306385|NCT01229111|O1|Outcome|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.~cediranib maleate: Given PO~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
306386|NCT01229111|O1|Outcome|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.~cediranib maleate: Given PO~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
306387|NCT01229111|E1|Reported Event|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.~cediranib maleate: Given PO~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
306388|NCT01228968|B1|Baseline|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
306389|NCT01228968|P1|Participant Flow|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
306390|NCT01228968|O1|Outcome|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
306431|NCT01228747|P1|Participant Flow|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily for 28 weeks"
306391|NCT01228968|O1|Outcome|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
306392|NCT01228968|O1|Outcome|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
306393|NCT01228968|O1|Outcome|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
306394|NCT01228968|E1|Reported Event|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
306395|NCT01228929|B4|Baseline|Total|Total of all reporting groups
306396|NCT01228929|B3|Baseline|Meibomian Gland Dysfunction (MGD)|Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation.
306397|NCT01228929|B2|Baseline|Aqueous Deficiency Dry Eye (ADDE)|Subjects with low tear volume measured by Schirmer's test less than 10 mm.
306398|NCT01228929|B1|Baseline|Normal|Subjects with no clinical diagnosis or symptoms of dry eye.
306399|NCT01228929|P3|Participant Flow|Meibomian Gland Dysfunction (MGD)|Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation. Each participant completed 3 environmental conditions. Nominal is 75 degrees F and 40% relative humidity. Low humidity is 20% relative humidity and 75 degrees F. High temperature is 85 degrees F and 40% relative humidity.
306400|NCT01228929|P2|Participant Flow|Aqueous Deficiency Dry Eye (ADDE)|Subjects with low tear volume measured by Schirmer's test less than 10 mm. Each participant completed 3 environmental conditions. Nominal is 75 degrees F and 40% relative humidity. Low humidity is 20% relative humidity and 75 degrees F. High temperature is 85 degrees F and 40% relative humidity.
306401|NCT01228929|P1|Participant Flow|Normal|Subjects with no clinical diagnosis or symptoms of dry eye. Each participant completed 3 environmental conditions. Nominal is 75 degrees F and 40% relative humidity. Low humidity is 20% relative humidity and 75 degrees F. High temperature is 85 degrees F and 40% relative humidity.
306402|NCT01228929|O3|Outcome|Meibomian Gland Dysfunction (MGD)|Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation.
306403|NCT01228929|O2|Outcome|Aqueous Deficiency Dry Eye (ADDE)|Subjects with low tear volume measured by Schirmer's test less than 10 mm.
306404|NCT01228929|O1|Outcome|Normal|Subjects with no clinical diagnosis or symptoms of dry eye.
306405|NCT01228929|E3|Reported Event|Meibomian Gland Dysfunction (MGD)|Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation.
306406|NCT01228929|E2|Reported Event|Aqueous Deficiency Dry Eye (ADDE)|Subjects with low tear volume measured by Schirmer's test less than 10 mm.
306407|NCT01228929|E1|Reported Event|Normal|Subjects with no clinical diagnosis or symptoms of dry eye.
306408|NCT01228903|B3|Baseline|Total|Total of all reporting groups
306409|NCT01228903|B2|Baseline|Allopurinol|"Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group.~Allopurinol: Xanthine oxidase inhibitor- effective at lowering uric acid levels."
306410|NCT01228903|B1|Baseline|Control|"Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function.~Placebo: Placebo tablets with no active ingredient"
306411|NCT01228903|P2|Participant Flow|Allopurinol|"Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group.~Allopurinol: Xanthine oxidase inhibitor- effective at lowering uric acid levels."
306412|NCT01228903|P1|Participant Flow|Control|"Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function.~Placebo: Placebo tablets with no active ingredient"
306413|NCT01228903|O2|Outcome|Allopurinol|Allopurinol: Xanthine oxidase inhibitor
306414|NCT01228903|O1|Outcome|Control|Placebo: Placebo tablets with no active ingredient
306415|NCT01228903|O2|Outcome|Allopurinol|Allopurinol: Xanthine oxidase inhibitor
306416|NCT01228903|O1|Outcome|Control|Placebo: Placebo tablets with no active ingredient
306417|NCT01228903|O2|Outcome|Allopurinol|Allopurinol: Xanthine oxidase inhibitor
306418|NCT01228903|O1|Outcome|Control|Placebo: Placebo tablets with no active ingredient
306419|NCT01228903|O2|Outcome|Allopurinol|Allopurinol: Xanthine oxidase inhibitor
306420|NCT01228903|O1|Outcome|Control|Placebo: Placebo tablets with no active ingredient
306421|NCT01228903|O2|Outcome|Allopurinol|Allopurinol: Xanthine oxidase inhibitor
306422|NCT01228903|O1|Outcome|Control|Placebo: Placebo tablets with no active ingredient
306423|NCT01228903|O2|Outcome|Allopurinol|Allopurinol: Xanthine oxidase inhibitor
306424|NCT01228903|O1|Outcome|Control|Placebo: Placebo tablets with no active ingredient
306425|NCT01228903|E2|Reported Event|Allopurinol|"Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group.~Allopurinol: Xanthine oxidase inhibitor- effective at lowering uric acid levels."
306426|NCT01228903|E1|Reported Event|Control|"Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function.~Placebo: Placebo tablets with no active ingredient"
306427|NCT01228747|B3|Baseline|Total|Total of all reporting groups
306428|NCT01228747|B2|Baseline|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
306429|NCT01228747|B1|Baseline|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily"
306430|NCT01228747|P2|Participant Flow|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
306432|NCT01228747|O2|Outcome|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
306433|NCT01228747|O1|Outcome|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily for 28 weeks"
306434|NCT01228747|O2|Outcome|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
306435|NCT01228747|O1|Outcome|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily for 28 weeks"
306436|NCT01228747|O2|Outcome|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
306437|NCT01228747|O1|Outcome|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily for 28 weeks"
306438|NCT01228747|O2|Outcome|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
306439|NCT01228747|O1|Outcome|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily for 28 weeks"
306440|NCT01228747|O2|Outcome|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
306441|NCT01228747|O1|Outcome|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily for 28 weeks"
306442|NCT01228747|E2|Reported Event|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
306443|NCT01228747|E1|Reported Event|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily for 28 weeks"
306444|NCT01228734|B3|Baseline|Total|Total of all reporting groups
306445|NCT01228734|B2|Baseline|FOLFOX-4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
306446|NCT01228734|B1|Baseline|Cetuximab + FOLFOX-4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
306447|NCT01228734|P2|Participant Flow|FOLFOX4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
306448|NCT01228734|P1|Participant Flow|Cetuximab + FOLFOX4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-fluorouracil (5-FU)/folinic acid (FA). Cetuximab was always administered every 7 days with an initial dose of 400 milligram per square meter (mg/m^2) at 5 milligram per minute (mg/min) and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
306449|NCT01228734|O2|Outcome|FOLFOX-4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
306450|NCT01228734|O1|Outcome|Cetuximab + FOLFOX-4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
306451|NCT01228734|O2|Outcome|FOLFOX-4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
306466|NCT01228591|O2|Outcome|Acuvue Advance|Acuvue Advance contact lenses worn
306467|NCT01228591|O1|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses worn
306452|NCT01228734|O1|Outcome|Cetuximab + FOLFOX-4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
306453|NCT01228734|O2|Outcome|FOLFOX-4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
306454|NCT01228734|O1|Outcome|Cetuximab + FOLFOX-4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
306455|NCT01228734|O2|Outcome|FOLFOX-4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
306456|NCT01228734|O1|Outcome|Cetuximab + FOLFOX-4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
306457|NCT01228734|O2|Outcome|FOLFOX-4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
306458|NCT01228734|O1|Outcome|Cetuximab + FOLFOX-4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
306459|NCT01228734|E2|Reported Event|FOLFOX-4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
306460|NCT01228734|E1|Reported Event|Cetuximab + FOLFOX-4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
306461|NCT01228591|B1|Baseline|All Subjects|Subjects who were randomized and successfully completed the study.
306462|NCT01228591|P2|Participant Flow|Acuvue Advance/ Acuvue Advance Plus|Group 1 wore AAP first and AA second. Group 2 wore AA first and AAP second
306463|NCT01228591|P1|Participant Flow|Acuvue Advance Plus/ Acuvue Advance|Group 1 wore AAP first and AA second. Group 2 wore AA first and AAP second
306464|NCT01228591|O2|Outcome|Acuvue Advance|Acuvue Advance contact lenses worn
306465|NCT01228591|O1|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses worn
306475|NCT01228591|O1|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses-Binocular measurements
306476|NCT01228591|E2|Reported Event|Acuvue Advance|Acuvue Advance contact lenses
306477|NCT01228591|E1|Reported Event|Acuvue Advance Plus|Acuvue Advance Plus contact lenses
306478|NCT01228435|B3|Baseline|Total|Total of all reporting groups
306479|NCT01228435|B2|Baseline|ALK-inhibitor Pre-treated|Prior exposure to ALK inhibitor
306480|NCT01228435|B1|Baseline|ALK-inhibitor Naive|No prior exposure to ALK-inhibitor
306481|NCT01228435|P2|Participant Flow|ALK-inhibitor Pre-treated|Patients in this arm had prior exposure to an ALK inhibitor and were treated with IPI-504 at 225 mg/m2 twice a week for 2 weeks followed by 10 days off therapy, cycles repeated every 21 days.
306482|NCT01228435|P1|Participant Flow|ALK-inhibitor Naive|Patients in this arm has no prior exposure to ALK-inhibitor and were treated with IPI-504 at 225 mg/m2 twice a week for 2 weeks followed by 10 days off therapy, cycles repeated every 21 days.
306483|NCT01228435|O2|Outcome|ALK-inhibitor Pre-treated|Patients in this arm had received prior exposure to ALK-inhibitor and were treated with IPI-504 at 225mg/m2 twice a week for 2 weeks followed by 10 days off with cycles repeating every 21 days.
306484|NCT01228435|O1|Outcome|ALK-inhibitor Naive|Patients in this arm has no prior exposure to ALK-inhibitor and were treated with IPI-504 at 225mg/m2 twice a week for 2 weeks followed by 10 days off with cycles repeating every 21 days.
306485|NCT01228435|O2|Outcome|ALK-inhibitor Pre-treated|Patients in this arm had received prior exposure to ALK-inhibitor and were treated with IPI-504 at 225mg/m2 twice a week for 2 weeks followed by 10 days off with cycles repeating every 21 days.
306486|NCT01228435|O1|Outcome|ALK-inhibitor Naive|Patients in this arm has no prior exposure to ALK-inhibitor and were treated with IPI-504 at 225mg/m2 twice a week for 2 weeks followed by 10 days off with cycles repeating every 21 days.
306487|NCT01228435|E2|Reported Event|ALK-inhibitor Pre-treated|Prior exposure to ALK inhibitor
306488|NCT01228435|E1|Reported Event|ALK-inhibitor Naive|No prior exposure to ALK-inhibitor
306489|NCT01228175|B3|Baseline|Total|Total of all reporting groups
306490|NCT01228175|B2|Baseline|Microcrystal Cellulose|"Microcrystal cellulose placebo~Placebo: 25mg look alike riboflavin tablets to match active study medication."
306491|NCT01228175|B1|Baseline|Varenicline|"Varenicline~Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily"
306492|NCT01228175|P2|Participant Flow|Microcrystal Cellulose|"Microcrystal cellulose placebo~Placebo: 25mg look alike riboflavin tablets to match active study medication."
306493|NCT01228175|P1|Participant Flow|Varenicline|"Varenicline~Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily"
306494|NCT01228175|O2|Outcome|Microcrystal Cellulose|"Microcrystal cellulose placebo~Placebo: 25mg look alike riboflavin tablets to match active study medication."
306495|NCT01228175|O1|Outcome|Varenicline|"Varenicline~Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily"
306496|NCT01228175|E2|Reported Event|Microcrystal Cellulose|"Microcrystal cellulose placebo~Placebo: 25mg look alike riboflavin tablets to match active study medication."
306497|NCT01228175|E1|Reported Event|Varenicline|"Varenicline~Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily"
306498|NCT01228149|B3|Baseline|Total|Total of all reporting groups
306499|NCT01228149|B2|Baseline|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
306500|NCT01228149|B1|Baseline|Diamox/DexaEDO|"Patients receive Diamox (oral acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally.~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
306501|NCT01228149|P2|Participant Flow|Cosopt S|"Patients receive Cosopt S eye drops starting 28 days preoperatively~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
306502|NCT01228149|P1|Participant Flow|Diamox/DexaEDO|"Patients receive oral acetazolamide starting 28 days preoperatively. 7 days preoperatively dexamethasone eyedrops without preservatives are applied additionally.~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
306503|NCT01228149|O2|Outcome|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days before trabeculectomy.~Trabeculectomy with preoperative Cosopt S treatment: Filtrating glaucoma surgery, preoperative treatment with Cosopt S (dorzolamide/timolol) 28 day prior surgery."
306504|NCT01228149|O1|Outcome|Diamox/DexaEDO|"Patients receive Diamox (oral acetazolamide) starting 28 days Prior to trabeculectomy. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally. Patient will undergo trabeculectomy.~Trabeculectomy with preoperative Diamox/DexaEDO treatment: Filtrating glaucoma surgery, preoperative treatment with Diamox (acetazolamide) 28 day prior surgery. DexaEDO (dexamethasone) 7 days prior surgery"
306505|NCT01228149|O2|Outcome|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
306506|NCT01228149|O1|Outcome|Diamox/DexaEDO|"Patients receive Diamox (oral acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally.~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
306507|NCT01228149|O2|Outcome|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
306508|NCT01228149|O1|Outcome|Diamox/DexaEDO|"Patients receive Diamox (oral acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally.~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
306509|NCT01228149|O2|Outcome|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
306510|NCT01228149|O1|Outcome|Diamox/DexaEDO|"Patients receive Diamox (oral acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally.~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
306511|NCT01228149|O2|Outcome|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
306512|NCT01228149|O1|Outcome|Diamox/DexaEDO|"Patients receive Diamox (oral acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally.~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
306513|NCT01228149|O2|Outcome|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
306514|NCT01228149|O1|Outcome|Diamox/DexaEDO|"Patients receive Diamox (oral acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally.~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
306515|NCT01228149|O2|Outcome|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
306516|NCT01228149|O1|Outcome|Diamox/DexaEDO|"Patients receive Diamox (oral acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally.~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
306517|NCT01228149|O2|Outcome|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days before trabeculectomy.~Trabeculectomy with preoperative Cosopt S treatment: Filtrating glaucoma surgery, preoperative treatment with Cosopt S (dorzolamide/timolol) 28 day prior surgery."
306518|NCT01228149|O1|Outcome|Diamox/DexaEDO|"Patients receive Diamox (oral acetazolamide) starting 28 days Prior to trabeculectomy. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally. Patient will undergo trabeculectomy.~Trabeculectomy with preoperative Diamox/DexaEDO treatment: Filtrating glaucoma surgery, preoperative treatment with Diamox (acetazolamide) 28 day prior surgery. DexaEDO (dexamethasone) 7 days prior surgery"
306519|NCT01228149|O2|Outcome|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
306520|NCT01228149|O1|Outcome|Diamox/DexaEDO|"Patients receive oral Diamox (acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally.~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
306521|NCT01228149|E2|Reported Event|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
306522|NCT01228149|E1|Reported Event|Diamox/DexaEDO|"Patients receive Diamox (oral acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally.~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
306523|NCT01228084|B1|Baseline|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
306524|NCT01228084|P1|Participant Flow|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
306525|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
306526|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
306527|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
306528|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
306529|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
306530|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
306531|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
306532|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
306533|NCT01228084|E1|Reported Event|Sulpforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic
306534|NCT01228071|B1|Baseline|40 mg Daily Dose of Testosterone Gel 2%|"testosterone gel 2%~testosterone gel 2% : 40 mg testosterone gel 2%"
306535|NCT01228071|P1|Participant Flow|40 mg Daily Dose of Testosterone Gel 2%|"testosterone gel 2%~testosterone gel 2% : 40 mg testosterone gel 2%"
306536|NCT01228071|O1|Outcome|40 mg Daily Dose of Testosterone Gel 2%|"testosterone gel 2%~testosterone gel 2% : 40 mg testosterone gel 2%"
306537|NCT01228071|O1|Outcome|40 mg Daily Dose of Testosterone Gel 2%|"testosterone gel 2%~testosterone gel 2% : 40 mg testosterone gel 2%"
306538|NCT01228071|O1|Outcome|40 mg Daily Dose of Testosterone Gel 2%|"testosterone gel 2%~testosterone gel 2% : 40 mg testosterone gel 2%"
306539|NCT01228071|E1|Reported Event|EN3350 (Testosterone Gel 2%)|"testosterone gel 2%~testosterone gel 2% : 40 mg testosterone gel 2%"
306540|NCT01228019|B1|Baseline|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
306541|NCT01228019|P1|Participant Flow|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
306542|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
306543|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
306544|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
306545|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
306546|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
306547|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
306548|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
306549|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
306550|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
306551|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
306552|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
306553|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
306554|NCT01228019|E1|Reported Event|ALL PARTICIPANTS|
306555|NCT01227993|B1|Baseline|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
306556|NCT01227993|P1|Participant Flow|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
306557|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
306558|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
306559|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
306560|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
306561|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
306562|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
306563|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
306564|NCT01227993|E1|Reported Event|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
306565|NCT01227980|B3|Baseline|Total|Total of all reporting groups
306566|NCT01227980|B2|Baseline|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
306567|NCT01227980|B1|Baseline|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
306568|NCT01227980|P2|Participant Flow|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
306569|NCT01227980|P1|Participant Flow|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
306570|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
306571|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
306572|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
306573|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
306574|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
306575|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
306576|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
306577|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
306578|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
306579|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
306580|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
306581|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
306582|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
306583|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
306584|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
306585|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
306586|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
306587|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
306588|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
306589|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
306590|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
306591|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
306592|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
306593|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
306594|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
306595|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
306596|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
306597|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
306598|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
306599|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
306600|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
306601|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
306602|NCT01227980|E2|Reported Event|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
306603|NCT01227980|E1|Reported Event|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
306604|NCT01227967|B3|Baseline|Total|Total of all reporting groups
306605|NCT01227967|B2|Baseline|Oseltamivir Monotherapy|"Drug: Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
306606|NCT01227967|B1|Baseline|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
306607|NCT01227967|P2|Participant Flow|Oseltamivir Monotherapy|"Drug: Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
306608|NCT01227967|P1|Participant Flow|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
306609|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
306610|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
306611|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
306612|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
306613|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
306689|NCT01227928|E1|Reported Event|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
306614|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
306615|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
306616|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
306617|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
306618|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
306619|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
306620|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
306621|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
306622|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
306623|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
306624|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
306625|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
306626|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
306627|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
306628|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
306629|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
306630|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
306631|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
306632|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
306633|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
306634|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
306635|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
306636|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
306637|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
306638|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
306639|NCT01227967|E2|Reported Event|Oseltamivir Monotherapy|"Drug: Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
306640|NCT01227967|E1|Reported Event|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir~Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
306641|NCT01227954|B1|Baseline|WBRT With Hippocampal Avoidance|Whole brain radiotherapy (WBRT) with hippocampal avoidance using intensity-modulated radiation therapy (IMRT)
306642|NCT01227954|P1|Participant Flow|WBRT With Hippocampal Avoidance|Whole brain radiotherapy (WBRT) with hippocampal avoidance using intensity-modulated radiation therapy (IMRT)
306643|NCT01227954|O1|Outcome|WBRT With Hippocampal Avoidance|Whole brain radiotherapy (WBRT) with hippocampal avoidance using intensity-modulated radiation therapy (IMRT)
306644|NCT01227954|O1|Outcome|WBRT With Hippocampal Avoidance|Whole brain radiotherapy (WBRT) with hippocampal avoidance using intensity-modulated radiation therapy (IMRT)
306645|NCT01227954|O1|Outcome|WBRT With Hippocampal Avoidance|Whole brain radiotherapy (WBRT) with hippocampal avoidance using intensity-modulated radiation therapy (IMRT)
306646|NCT01227954|O1|Outcome|WBRT With Hippocampal Avoidance|Whole brain radiotherapy (WBRT) with hippocampal avoidance using intensity-modulated radiation therapy (IMRT)
306647|NCT01227954|O1|Outcome|WBRT With Hippocampal Avoidance|Whole brain radiotherapy (WBRT) with hippocampal avoidance using intensity-modulated radiation therapy (IMRT)
306648|NCT01227954|O1|Outcome|WBRT With Hippocampal Avoidance|Whole brain radiotherapy (WBRT) with hippocampal avoidance using intensity-modulated radiation therapy (IMRT)
306649|NCT01227954|O1|Outcome|WBRT With Hippocampal Avoidance|Whole brain radiotherapy (WBRT) with hippocampal avoidance using intensity-modulated radiation therapy (IMRT)
306650|NCT01227954|O1|Outcome|WBRT With Hippocampal Avoidance|Whole brain radiotherapy (WBRT) with hippocampal avoidance using intensity-modulated radiation therapy (IMRT)
306651|NCT01227954|O1|Outcome|WBRT With Hippocampal Avoidance|Whole brain radiotherapy (WBRT) with hippocampal avoidance using intensity-modulated radiation therapy (IMRT)
306652|NCT01227954|E1|Reported Event|WBRT With Hippocampal Avoidance|Whole brain radiotherapy (WBRT) with hippocampal avoidance using intensity-modulated radiation therapy (IMRT)
306653|NCT01227928|B3|Baseline|Total|Total of all reporting groups
306654|NCT01227928|B2|Baseline|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
306655|NCT01227928|B1|Baseline|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
306656|NCT01227928|P2|Participant Flow|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
306657|NCT01227928|P1|Participant Flow|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
306658|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
306659|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
306660|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
306661|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
306662|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
306663|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
306664|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
306665|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
306666|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
306667|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
306668|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
306669|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
306670|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
306671|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
306672|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
306673|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
306674|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
306675|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
306676|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
306677|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
306678|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
306679|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
306680|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
306681|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
306682|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
306683|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
306684|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
306685|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
306686|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
306687|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
306688|NCT01227928|E2|Reported Event|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
306690|NCT01227902|B5|Baseline|Total|Total of all reporting groups
306691|NCT01227902|B4|Baseline|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306692|NCT01227902|B3|Baseline|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306693|NCT01227902|B2|Baseline|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306694|NCT01227902|B1|Baseline|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306695|NCT01227902|P4|Participant Flow|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306696|NCT01227902|P3|Participant Flow|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306697|NCT01227902|P2|Participant Flow|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306698|NCT01227902|P1|Participant Flow|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306699|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
306700|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306701|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306702|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306703|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306705|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306706|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306707|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306708|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306709|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
306710|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306711|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306712|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306713|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306714|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
306715|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306716|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306717|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306732|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306718|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306719|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
306720|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306721|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306722|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306723|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306724|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
306725|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306726|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306727|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306728|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306729|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
306730|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306731|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306788|NCT01227889|B3|Baseline|Total|Total of all reporting groups
306845|NCT01227824|O1|Outcome|DTG 50 mg Once a Day|Participants received DTG 50 mg once a day in combination with NRTI therapy, either with ABC/3TC or TDF/FTC. Participants were given the opportunity to receive DTG 50 mg once a day during an Open-label Phase of the study.
306733|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306734|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
306735|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306736|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306737|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306738|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306739|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
306740|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306741|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306742|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306743|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306744|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
306745|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306746|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306837|NCT01227824|O1|Outcome|DTG 50 mg Once a Day|Participants received DTG 50 mg once a day in combination with NRTI therapy, either with ABC/3TC or TDF/FTC. Participants were given the opportunity to receive DTG 50 mg once a day during an Open-label Phase of the study.
306838|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received RTG 400 mg BID in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
306747|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306748|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306749|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
306750|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306751|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306752|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306753|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306754|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
306755|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306756|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306757|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306758|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306759|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
306760|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306839|NCT01227824|O1|Outcome|DTG 50 mg Once a Day|Participants received DTG 50 mg once a day in combination with NRTI therapy, either with ABC/3TC or TDF/FTC. Participants were given the opportunity to receive DTG 50 mg once a day during an Open-label Phase of the study.
306840|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received RTG 400 mg BID in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
306761|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306762|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306763|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306764|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
306765|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306766|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306767|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306768|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306769|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
306770|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306771|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306772|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306773|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306774|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
306841|NCT01227824|O1|Outcome|DTG 50 mg Once a Day|Participants received DTG 50 mg once a day in combination with NRTI therapy, either with ABC/3TC or TDF/FTC. Participants were given the opportunity to receive DTG 50 mg once a day during an Open-label Phase of the study.
306842|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received RTG 400 mg BID in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
306775|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306776|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306777|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306778|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306779|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
306780|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306781|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306782|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306783|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306784|NCT01227902|E4|Reported Event|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306785|NCT01227902|E3|Reported Event|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306786|NCT01227902|E2|Reported Event|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306787|NCT01227902|E1|Reported Event|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
306789|NCT01227889|B2|Baseline|DTIC 1000 mg/m^2 in RP; GSK2118436 in Crossover Phase|In the RP, par. received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Par. continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Par. who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Par. who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover par. continued on GSK2118436 until further DP was noted. After DP on GSK2118436, par. were followed for response, progression, survival, and further anti-cancer therapy.
306790|NCT01227889|B1|Baseline|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
306791|NCT01227889|P2|Participant Flow|DTIC 1000 mg/m^2 in RP; GSK2118436 in Crossover Phase|In the RP, par. received intravenous (IV) Dacarbazine (DTIC) 1000 mg per meters squared (mg/m^2) every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Par. continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Par. who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Par. who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover par. continued on GSK2118436 until further DP was noted. After DP on GSK2118436, par. were followed for response, progression, survival, and further anti-cancer therapy.
306792|NCT01227889|P1|Participant Flow|GSK2118436 150 mg BID|Participants (par.) were randomly assigned to receive oral GSK2118436 150 milligrams (mg) twice a day (BID). Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until disease progression (DP), death, the occurrence of an unacceptable adverse event (AE), or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
306793|NCT01227889|O1|Outcome|All Screened Participants|Specimens were tested for V600E mutations to determine trial eligibility with the CTA were retested with the THxID BRAF test. The analytical agreement between the THxID BRAF and the CTA was evaluated for both mutation positive and mutation negative specimens from all sites.
306794|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
306795|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
306796|NCT01227889|O1|Outcome|GSK25118436 in Crossover Phase|Participants who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Participants who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover participants continued on GSK2118436 until further DP was noted. After DP on GSK2118436, participants were followed for response, progression, survival, and further anti-cancer therapy.
306797|NCT01227889|O1|Outcome|GSK25118436 in Crossover Phase|Participants who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Participants who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover participants continued on GSK2118436 until further DP was noted. After DP on GSK2118436, participants were followed for response, progression, survival, and further anti-cancer therapy.
306798|NCT01227889|O1|Outcome|GSK25118436 in Crossover Phase|Participants who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Participants who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover participants continued on GSK2118436 until further DP was noted. After DP on GSK2118436, participants were followed for response, progression, survival, and further anti-cancer therapy.
306799|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
306843|NCT01227824|O1|Outcome|DTG 50 mg Once a Day|Participants received DTG 50 mg once a day in combination with NRTI therapy, either with ABC/3TC or TDF/FTC. Participants were given the opportunity to receive DTG 50 mg once a day during an Open-label Phase of the study.
306800|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
306801|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
306802|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
306803|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
306804|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until disease DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
306805|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
306806|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until disease DP, death, the occurrence of an unacceptable adverse AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
306807|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants. continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
306808|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
306809|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
306810|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
306811|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received intravenous (IV) Dacarbazine (DTIC) 1000 milligrams per meters squared (mg/m^2) every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
306844|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received RTG 400 mg BID in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
307025|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
307026|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
306812|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 milligrams (mg) twice a day (BID). Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until disease progression (DP), death, the occurrence of an unacceptable adverse event (AE), or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
306813|NCT01227889|E3|Reported Event|GSK25118436 in the Crossover Phase|Participants who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Participants who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover participants continued on GSK2118436 until further DP was noted. After DP on GSK2118436, participants were followed for response, progression, survival, and further anti-cancer therapy.
306814|NCT01227889|E2|Reported Event|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
306815|NCT01227889|E1|Reported Event|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
306816|NCT01227824|B3|Baseline|Total|Total of all reporting groups
306817|NCT01227824|B2|Baseline|RTG 400 mg BID|Participants received RTG 400 mg BID in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
306818|NCT01227824|B1|Baseline|DTG 50 mg Once a Day|Participants received DTG 50 mg once a day in combination with NRTI therapy, either with ABC/3TC or TDF)/FTC. Participants were given the opportunity to receive DTG 50 mg once a day during an Open-label Phase of the study.
306819|NCT01227824|P3|Participant Flow|DTG 50 mg Once a Day (Open-label)|Participants who successfully completed 96 weeks of double blind phase continued to receive DTG 50 mg once a day during open label phase, until dolutegravir was locally available commercially. Participants received DTG 50 mg once a day in combination with NRTI therapy, with either ABC/3TC or TDF/FTC.
306820|NCT01227824|P2|Participant Flow|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
306821|NCT01227824|P1|Participant Flow|DTG 50 mg Once a Day|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg once a day during an Open-label Phase of the study.
306822|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received RTG 400 mg BID in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
306823|NCT01227824|O1|Outcome|DTG 50 mg Once a Day|Participants received DTG 50 mg once a day in combination with NRTI therapy, either with ABC/3TC or TDF/FTC. Participants were given the opportunity to receive DTG 50 mg once a day during an Open-label Phase of the study.
306824|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received RTG 400 mg BID in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
306825|NCT01227824|O1|Outcome|DTG 50 mg Once a Day|Participants received DTG 50 mg once a day in combination with NRTI therapy, either with ABC/3TC or TDF/FTC. Participants were given the opportunity to receive DTG 50 mg once a day during an Open-label Phase of the study.
306826|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received RTG 400 mg BID in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
306827|NCT01227824|O1|Outcome|DTG 50 mg Once a Day|Participants received DTG 50 mg once a day in combination with NRTI therapy, either with ABC/3TC or TDF/FTC. Participants were given the opportunity to receive DTG 50 mg once a day during an Open-label Phase of the study.
306828|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received RTG 400 mg BID in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
306829|NCT01227824|O1|Outcome|DTG 50 mg Once a Day|Participants received DTG 50 mg once a day in combination with NRTI therapy, either with ABC/3TC or TDF/FTC. Participants were given the opportunity to receive DTG 50 mg once a day during an Open-label Phase of the study.
306830|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received RTG 400 mg BID in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
306831|NCT01227824|O1|Outcome|DTG 50 mg Once a Day|Participants received DTG 50 mg once a day in combination with NRTI therapy, either with ABC/3TC or TDF/FTC. Participants were given the opportunity to receive DTG 50 mg once a day during an Open-label Phase of the study.
306832|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received RTG 400 mg BID in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
306833|NCT01227824|O1|Outcome|DTG 50 mg Once a Day|Participants received DTG 50 mg once a day in combination with NRTI therapy, either with ABC/3TC or TDF/FTC. Participants were given the opportunity to receive DTG 50 mg once a day during an Open-label Phase of the study.
306834|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received RTG 400 mg BID in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
306835|NCT01227824|O1|Outcome|DTG 50 mg Once a Day|Participants received DTG 50 mg once a day in combination with NRTI therapy, either with ABC/3TC or TDF/FTC. Participants were given the opportunity to receive DTG 50 mg once a day during an Open-label Phase of the study.
306836|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received RTG 400 mg BID in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
307027|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
306846|NCT01227824|E3|Reported Event|DTG 50 mg Once a Day (Open-label)|Participants who successfully completed 96 weeks of double blind phase continued to receive DTG 50 mg once a day during open label phase, until DTG was locally available commercially. Participants received DTG 50 mg once a day in combination with NRTI therapy, with either ABC/3TC or TDF/FTC.
306847|NCT01227824|E2|Reported Event|RTG 400mg BID|Participants received RTG 400 mg BID in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
306848|NCT01227824|E1|Reported Event|DTG 50 mg Once a Day|Participants received DTG 50 mg once a day in combination with NRTI therapy, either with ABC/3TC or TDF/FTC. Participants were given the opportunity to receive DTG 50 mg once a day during an Open-label Phase of the study.
306849|NCT01227785|B1|Baseline|INCEPTA ICD and CRT-D|Patients implanted with Incepta ICD or CRT-D device
306850|NCT01227785|P1|Participant Flow|INCEPTA ICD and CRT-D|Patients implanted with Incepta ICD or CRT-D device
306851|NCT01227785|O1|Outcome|INCEPTA CRT-D and ICD (Overall Study Population)|
306852|NCT01227785|O2|Outcome|INCEPTA ICD|
306853|NCT01227785|O1|Outcome|INCEPTA CRT-D|
306854|NCT01227785|O2|Outcome|INCEPTA ICD|
306855|NCT01227785|O1|Outcome|INCEPTA CRT-D|
306856|NCT01227785|O2|Outcome|INCEPTA ICD|
306857|NCT01227785|O1|Outcome|INCEPTA CRT-D|
306858|NCT01227785|O2|Outcome|INCEPTA ICD|
306859|NCT01227785|O1|Outcome|INCEPTA CRT-D|
306860|NCT01227785|O2|Outcome|INCEPTA ICD|
306861|NCT01227785|O1|Outcome|INCEPTA CRT-D|
306862|NCT01227785|O2|Outcome|INCEPTA ICD|
306863|NCT01227785|O1|Outcome|INCEPTA CRT-D|
306864|NCT01227785|O2|Outcome|INCEPTA ICD|
306865|NCT01227785|O1|Outcome|INCEPTA CRT-D|
306866|NCT01227785|O1|Outcome|INCEPTA CRT-D and ICD Patients (Overall Study Population)|
306867|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
306868|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306869|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
306870|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306871|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
306872|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306873|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
306874|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306875|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
306876|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306877|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
306878|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306879|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306880|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306881|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306882|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
306883|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306884|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
306885|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306886|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
306887|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306888|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
306889|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306890|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
306891|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306892|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
306893|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306894|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306895|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306896|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306897|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
306898|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306899|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
306900|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306901|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
306902|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306903|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
306904|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306905|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
306906|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306907|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
306908|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306909|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306910|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306911|NCT01227785|O2|Outcome|Group 2: Patients Without a HFE|Patients who did not experience a protocol-defined HFE
306912|NCT01227785|O1|Outcome|Group1: Patients With a HFE|Patients who experienced a protocol-defined HF event
306913|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
306914|NCT01227785|E1|Reported Event|INCEPTA ICD and CRT-D|Patients implanted with Incepta ICD or CRT-D device
306915|NCT01227707|B1|Baseline|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
306926|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
306916|NCT01227707|P1|Participant Flow|Bevacizumab (Bv)+Capecitabine/Bv+Leucovorin+5-fluorouracil|Participants received bevacizumab 5 milligrams per kilogram (mg/kg) intravenously (IV) on Days -14, 1, 15, and 29 and capecitabine 825 milligrams per square meter (mg/m^2) orally (PO) twice daily (BID) from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gray (Gy) administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-fluorouracil (5-FU) 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
306917|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
306918|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
306919|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
306920|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
306921|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
306922|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
306923|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
306924|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
306925|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
307021|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307022|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
306927|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
306928|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
306929|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
306930|NCT01227707|E1|Reported Event|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
306931|NCT01227681|B4|Baseline|Total|Total of all reporting groups
306932|NCT01227681|B3|Baseline|Placebo|normal saline 0.9% injection
306933|NCT01227681|B2|Baseline|Low Dose G-CSF Injection for Parkinson's Disease|1.65 ug/kg/day for consecutive 5 days of each 60 day cycle
306934|NCT01227681|B1|Baseline|High Dose G-CSF Injection for Parkinson's Disease|3.3 ug/kg/day for consecutive 5 days of each 60 day cycle
306935|NCT01227681|P3|Participant Flow|Placebo|subcutaneous Normal saline for consecutive 5 days of each 60 day cycle
306936|NCT01227681|P2|Participant Flow|Low Dose G-CSF|1.65ug/kg/day for consecutive 5 days of each 60 day cycle
306937|NCT01227681|P1|Participant Flow|G-CSF|3.3ug/kg/day for consecutive 5 days of each 60 day cycle
306938|NCT01227681|O1|Outcome|G-CSF Injection for Parkinson's Disease|3.3ug/kg/day for consecutive 5 days of each 60 day cycle
306939|NCT01227681|E1|Reported Event|G-CSF Injection for Parkinson's Disease|3.3ug/kg/day for consecutive 5 days of each 60 day cycle
306940|NCT01227668|B3|Baseline|Total|Total of all reporting groups
306941|NCT01227668|B2|Baseline|Placebo|Phase 2: Participants received placebo for 16 weeks.
306942|NCT01227668|B1|Baseline|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 2: Aripiprazole was continued at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
306943|NCT01227668|P2|Participant Flow|Placebo|Phase 2 only: Participants received placebo for 16 weeks.
306944|NCT01227668|P1|Participant Flow|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|"Phase 1: Participants received an initial dose of aripiprazole 2 mg daily, titered up to 5, 10, or 15 mg once daily to optimize clinical benefit, for a maximum of 26 weeks.~Phase 2: Aripiprazole was continued at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability."
306945|NCT01227668|O2|Outcome|Placebo|Phase 2 only: Participants received placebo for 16 weeks.
306946|NCT01227668|O1|Outcome|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 2: Participants continued aripiprazole at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
306947|NCT01227668|O1|Outcome|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 1: Participants received an initial dose of aripiprazole 2 mg daily, titered up to 5, 10, or 15 mg once daily to optimize clinical benefit, for a maximum of 26 weeks.
306948|NCT01227668|O2|Outcome|Placebo|Phase 2 only: Participants received placebo (pb)for 16 weeks.
306949|NCT01227668|O1|Outcome|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 2: Participants continued aripiprazole (ARP) at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
306950|NCT01227668|O2|Outcome|Placebo|Phase 2 only: Participants received placebo for 16 weeks.
306951|NCT01227668|O1|Outcome|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 2: Participants continued aripiprazole at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
306952|NCT01227668|O2|Outcome|Placebo|Phase 2 only: Participants received placebo for 16 weeks.
306953|NCT01227668|O1|Outcome|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 2: Participants continued aripiprazole at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
306954|NCT01227668|E3|Reported Event|Placebo (Phase 2 Only)|Phase 2 only: Participants received placebo for 16 weeks.
307023|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
307024|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
306955|NCT01227668|E2|Reported Event|Aripiprazole, 2-15 mg (Phase 2)|Phase 2: Participants continued aripiprazole at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
306956|NCT01227668|E1|Reported Event|Aripiprazole, 2-15 mg (Phase 1)|Phase 1: Participants received an initial dose of aripiprazole 2 mg daily, titered up to 5, 10, or 15 mg once daily to optimize clinical benefit, for a maximum of 26 weeks.
306957|NCT01227655|B4|Baseline|Total|Total of all reporting groups
306958|NCT01227655|B3|Baseline|Placebo|Placebo: comparator
306959|NCT01227655|B2|Baseline|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
306960|NCT01227655|B1|Baseline|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
306961|NCT01227655|P3|Participant Flow|Placebo|Placebo: comparator
306962|NCT01227655|P2|Participant Flow|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
306963|NCT01227655|P1|Participant Flow|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
306964|NCT01227655|O3|Outcome|Placebo|Placebo: comparator
306965|NCT01227655|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
306966|NCT01227655|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
306967|NCT01227655|O3|Outcome|Placebo|Placebo: comparator
306968|NCT01227655|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
306969|NCT01227655|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
306970|NCT01227655|O3|Outcome|Placebo|Placebo: comparator
306971|NCT01227655|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
306972|NCT01227655|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
306973|NCT01227655|O3|Outcome|Placebo|Placebo: comparator
306974|NCT01227655|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
306975|NCT01227655|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
306976|NCT01227655|E3|Reported Event|Placebo|Placebo: comparator
306977|NCT01227655|E2|Reported Event|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
306978|NCT01227655|E1|Reported Event|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
306979|NCT01227629|B11|Baseline|Total|Total of all reporting groups
306980|NCT01227629|B10|Baseline|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
306981|NCT01227629|B9|Baseline|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
306982|NCT01227629|B8|Baseline|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
306983|NCT01227629|B7|Baseline|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
306984|NCT01227629|B6|Baseline|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
306985|NCT01227629|B5|Baseline|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
306986|NCT01227629|B4|Baseline|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
306987|NCT01227629|B3|Baseline|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
306988|NCT01227629|B2|Baseline|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
306989|NCT01227629|B1|Baseline|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
306990|NCT01227629|P10|Participant Flow|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
306991|NCT01227629|P9|Participant Flow|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
306992|NCT01227629|P8|Participant Flow|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
306993|NCT01227629|P7|Participant Flow|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
306994|NCT01227629|P6|Participant Flow|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
306995|NCT01227629|P5|Participant Flow|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
306996|NCT01227629|P4|Participant Flow|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
306997|NCT01227629|P3|Participant Flow|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
306998|NCT01227629|P2|Participant Flow|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
306999|NCT01227629|P1|Participant Flow|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
307000|NCT01227629|O17|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|Warfarin once daily
307001|NCT01227629|O16|Outcome|D300qd + ASA325qd|Dabigatran 300 mg once daily + ASA 325 mg once daily
307002|NCT01227629|O15|Outcome|D300bid + ASA325qd|Dabigatran 300 mg twice daily + ASA 325 mg once daily
307003|NCT01227629|O14|Outcome|D300qd + ASA81qd|Dabigatran 300 mg once daily + ASA 81 mg once daily
307004|NCT01227629|O13|Outcome|D300bid + ASA81qd|Dabigatran 300 mg twice daily + ASA 81 mg once daily
307005|NCT01227629|O12|Outcome|D300qd|Dabigatran 300 mg once daily
307006|NCT01227629|O11|Outcome|D300bid|Dabigatran 300 mg twice daily
307007|NCT01227629|O10|Outcome|D150qd + ASA325qd|Dabigatran 150 mg once daily + ASA 325 mg once daily
307008|NCT01227629|O9|Outcome|D150bid + ASA325qd|Dabigatran 150 mg twice daily + ASA 325 mg once daily
307009|NCT01227629|O8|Outcome|D150qd + ASA81qd|Dabigatran 150 mg once daily + ASA 81 mg once daily
307010|NCT01227629|O7|Outcome|D150bid + ASA81qd|Dabigatran 150 mg twice daily + ASA 81 mg once daily
307011|NCT01227629|O6|Outcome|D150qd|Dabigatran 150 mg once daily
307012|NCT01227629|O5|Outcome|D150bid|Dabigatran 150 mg twice daily
307013|NCT01227629|O4|Outcome|D50bid + ASA325qd|Dabigatran 50 mg twice daily + ASA 325 mg once daily
307014|NCT01227629|O3|Outcome|D50bid + ASA81qd|Dabigatran 50 mg twice daily + ASA 81 mg once daily
307015|NCT01227629|O2|Outcome|D50qd|Dabigatran 50 mg once daily
307016|NCT01227629|O1|Outcome|D50bid|Dabigatran 50 mg twice daily
307017|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
307018|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307019|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307020|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
307028|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307029|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307030|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
307031|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307032|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307033|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
307034|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307035|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
307036|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
307037|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
307038|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307039|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307040|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
307041|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307042|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307043|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
307044|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307045|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
307046|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
307047|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
307048|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307049|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307050|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
307051|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307052|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307053|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
307054|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307055|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
307056|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
307057|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
307058|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307059|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307060|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
307061|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307062|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307063|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
307064|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307065|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
307066|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
307067|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
307068|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307069|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307070|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
307071|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307072|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307073|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
307074|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307075|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
307076|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
307077|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
307078|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307079|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307080|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
307081|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307082|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307083|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
307084|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307085|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
307086|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
307087|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
307088|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307089|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307090|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
307091|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307092|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307093|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
307094|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307095|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
307096|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
307097|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
307098|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307099|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307100|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
307101|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307102|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307103|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
307104|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307105|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
307106|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
307107|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
307108|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307109|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307110|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
307111|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307112|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307113|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
307114|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307115|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
307116|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
307117|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
307118|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307119|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307120|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
307121|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307122|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307123|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
307124|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307125|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
307126|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
307127|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
307128|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307129|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307130|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
307131|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307132|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307133|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
307134|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307135|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
307136|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
307137|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
307138|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307139|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307140|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
307141|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307142|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307143|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
307144|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307145|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
307146|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
307147|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
307148|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307149|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307150|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
307151|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307152|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307153|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
307154|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307155|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
307156|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
307157|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
307158|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307159|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307160|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
307161|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307162|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307163|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
307164|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307165|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
307166|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
307167|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
307168|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307169|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307170|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
307171|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307172|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307173|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
307174|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307175|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
307176|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
307177|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
307178|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307179|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307180|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
307181|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307182|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307183|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
307184|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307185|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
307186|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
307187|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
307188|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307189|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307190|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
307191|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307192|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307193|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
307194|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307195|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
307196|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
307197|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
307198|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307199|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307200|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
307201|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307202|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307203|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
307204|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307205|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
307206|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
307207|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
307208|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307209|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307210|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
307211|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307212|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
307213|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
307214|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
307215|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
307216|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
307217|NCT01227629|E17|Reported Event|Warfarin|Warfarin once daily
307218|NCT01227629|E16|Reported Event|D300qd + ASA325qd|Dabigatran 300 mg once daily + ASA 325 mg once daily
307219|NCT01227629|E15|Reported Event|D300bid + ASA325qd|Dabigatran 300 mg twice daily + ASA 325 mg once daily
307220|NCT01227629|E14|Reported Event|D300qd + ASA81qd|Dabigatran 300 mg once daily + ASA 81 mg once daily
307221|NCT01227629|E13|Reported Event|D300bid + ASA81qd|Dabigatran 300 mg twice daily + ASA 81 mg once daily
307222|NCT01227629|E12|Reported Event|D300qd|Dabigatran 300 mg once daily
307223|NCT01227629|E11|Reported Event|D300bid|Dabigatran 300 mg twice daily
307224|NCT01227629|E10|Reported Event|D150qd + ASA325qd|Dabigatran 150 mg once daily + ASA 325 mg once daily
307225|NCT01227629|E9|Reported Event|D150bid + ASA325qd|Dabigatran 150 mg twice daily + ASA 325 mg once daily
307226|NCT01227629|E8|Reported Event|D150qd + ASA81qd|Dabigatran 150 mg once daily + ASA 81 mg once daily
307227|NCT01227629|E7|Reported Event|D150bid + ASA81qd|Dabigatran 150 mg twice daily + ASA 81 mg once daily
307228|NCT01227629|E6|Reported Event|D150qd|Dabigatran 150 mg once daily
307229|NCT01227629|E5|Reported Event|D150bid|Dabigatran 150 mg twice daily
307230|NCT01227629|E4|Reported Event|D50bid + ASA325qd|Dabigatran 50 mg twice daily + ASA 325 mg once daily
307231|NCT01227629|E3|Reported Event|D50bid + ASA81qd|Dabigatran 50 mg twice daily + ASA 81 mg once daily
307232|NCT01227629|E2|Reported Event|D50qd|Dabigatran 50 mg once daily
307233|NCT01227629|E1|Reported Event|D50bid|Dabigatran 50 mg twice daily
307234|NCT01227577|B1|Baseline|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
307235|NCT01227577|P1|Participant Flow|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
307236|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
307237|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
307238|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
307239|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
307240|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
307241|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
307242|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
307243|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
307244|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
307245|NCT01227577|E1|Reported Event|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
307246|NCT01227564|B4|Baseline|Total|Total of all reporting groups
307247|NCT01227564|B3|Baseline|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307248|NCT01227564|B2|Baseline|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307249|NCT01227564|B1|Baseline|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307250|NCT01227564|P3|Participant Flow|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307251|NCT01227564|P2|Participant Flow|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307252|NCT01227564|P1|Participant Flow|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307253|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307254|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307255|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307256|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307257|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307258|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307259|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307260|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307467|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
307261|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307262|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307263|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307264|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307265|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307266|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307267|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307268|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307269|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307270|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307271|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307272|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307273|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307274|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307275|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307276|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307277|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307278|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307279|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307280|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307281|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307282|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307283|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307284|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307285|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307286|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307287|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307288|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307289|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307290|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307291|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307323|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307292|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307293|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307294|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307295|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307296|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307297|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307298|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307299|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307300|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307301|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307302|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307303|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307304|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307305|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307306|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307307|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307308|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307309|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307310|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307311|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307312|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307313|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307314|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307315|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307316|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307317|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307318|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307319|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307320|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307321|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307322|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307324|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307325|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307326|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307327|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307328|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307329|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307330|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307331|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307332|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307333|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307334|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307335|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307336|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307337|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307338|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307339|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307340|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307341|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307342|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307343|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307344|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307345|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307346|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307347|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307348|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307349|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307350|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307351|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307352|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307353|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307354|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307355|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307356|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307357|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307358|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307359|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307360|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307361|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307362|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307363|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307364|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307365|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307366|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307367|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307368|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307369|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307370|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307371|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307372|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307373|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307374|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307375|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307376|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307377|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307378|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307379|NCT01227564|E3|Reported Event|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307380|NCT01227564|E2|Reported Event|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307381|NCT01227564|E1|Reported Event|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
307382|NCT01227551|B1|Baseline|CVA21|CVA21 monotherapy
307383|NCT01227551|P1|Participant Flow|CVA21|CVA21 monotherapy
307384|NCT01227551|O1|Outcome|CVA21|CVA21 monotherapy
307385|NCT01227551|O1|Outcome|CVA21|CVA21 monotherapy
307386|NCT01227551|E1|Reported Event|CVA21|CVA21 monotherapy
307387|NCT01227512|B3|Baseline|Total|Total of all reporting groups
307463|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
307388|NCT01227512|B2|Baseline|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
307389|NCT01227512|B1|Baseline|Tolvaptan 15-60 mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
307390|NCT01227512|P2|Participant Flow|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
307391|NCT01227512|P1|Participant Flow|Tolvaptan 15-60 mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
307392|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
307393|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
307394|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
307395|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
307396|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
307397|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
307398|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may titrated based on serum sodium response.
307399|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
307400|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
307401|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
307402|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
307403|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
307404|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction be may titrated based on serum sodium response.
307405|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
307406|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
307407|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
307408|NCT01227512|E2|Reported Event|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
307409|NCT01227512|E1|Reported Event|Tolvaptan 15-60 mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
307410|NCT01227434|B3|Baseline|Total|Total of all reporting groups
307411|NCT01227434|B2|Baseline|Non-surgical Group|Patients not in need of surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
307412|NCT01227434|B1|Baseline|Surgical Group|PD 0332991 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
307413|NCT01227434|P2|Participant Flow|Non-surgical Group|Patients not in need of surgery treated with PD 0332991 at a dose of 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
307414|NCT01227434|P1|Participant Flow|Surgical Group|PD 0332991 125 mg daily for 7 days prior to an indicated, surgical resection for progression, and resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
307415|NCT01227434|O2|Outcome|Non-surgical Group|Patients not requiring surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
307464|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
307465|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
307466|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
307416|NCT01227434|O1|Outcome|Surgical Group|PD 0332991 at a dose of 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
307417|NCT01227434|O2|Outcome|Non-surgical Group|Patients not requiring surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
307418|NCT01227434|O1|Outcome|Surgical Group|PD 0332991 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
307419|NCT01227434|E2|Reported Event|Non-surgical Group|Patients not requiring surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
307420|NCT01227434|E1|Reported Event|Surgical Group|PD 0332991 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
307421|NCT01227421|B4|Baseline|Total|Total of all reporting groups
307422|NCT01227421|B3|Baseline|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
307423|NCT01227421|B2|Baseline|Placebo|placebo tablet twice daily with food for 5 days
307424|NCT01227421|B1|Baseline|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
307425|NCT01227421|P3|Participant Flow|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
307426|NCT01227421|P2|Participant Flow|Placebo|placebo tablet twice daily with food for 5 days
307427|NCT01227421|P1|Participant Flow|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
307428|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
307429|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
307430|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
307431|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
307432|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
307433|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
307434|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
307435|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
307436|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
307437|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
307438|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
307439|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
307440|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
307441|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
307442|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
307443|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
307444|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
307445|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
307446|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
307447|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
307448|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
307449|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
307450|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
307451|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
307452|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
307453|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
307454|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
307455|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
307456|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
307457|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
307458|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
307459|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
307460|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
307461|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
307462|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
307470|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
307471|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
307472|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
307473|NCT01227421|E3|Reported Event|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
307474|NCT01227421|E2|Reported Event|Placebo|placebo tablet twice daily with food for 5 days
307475|NCT01227421|E1|Reported Event|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
307476|NCT01227395|B3|Baseline|Total|Total of all reporting groups
307477|NCT01227395|B2|Baseline|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
307478|NCT01227395|B1|Baseline|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
307479|NCT01227395|P2|Participant Flow|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
307480|NCT01227395|P1|Participant Flow|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
307481|NCT01227395|O1|Outcome|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
307482|NCT01227395|O1|Outcome|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
307483|NCT01227395|O2|Outcome|Azithromycin Without Allergies|Participants without allergies who taking Azithromycin for Treatment according to Japanese Package Insert.
307484|NCT01227395|O1|Outcome|Azithromycin With Allergies|Participants with allergies who taking Azithromycin for Treatment according to Japanese Package Insert.
307485|NCT01227395|O2|Outcome|Azithromycin Without Renal Dysfunction|Participants without renal dysfunction who taking Azithromycin for Treatment according to Japanese Package Insert.
307486|NCT01227395|O1|Outcome|Azithromycin With Renal Dysfunction|Participants with renal dysfunction who taking Azithromycin for Treatment according to Japanese Package Insert.
307487|NCT01227395|O2|Outcome|Female|Female Participants taking Azithromycin for Treatment according to Japanese Package Insert.
307488|NCT01227395|O1|Outcome|Male|Male Participants taking Azithromycin for Treatment according to Japanese Package Insert.
307489|NCT01227395|O2|Outcome|>=65 Years|Participants with >=65 years who taking Azithromycin for Treatment according to Japanese Package Insert.
307490|NCT01227395|O1|Outcome|<65 Years|Participants with <65 years who taking Azithromycin for Treatment according to Japanese Package Insert.
307491|NCT01227395|O2|Outcome|Azithromycin Without Allergies|Participants without allergies who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
307492|NCT01227395|O1|Outcome|Azithromycin With Allergies|Participants with allergies who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
307493|NCT01227395|O2|Outcome|Azithromycin Without Renal Dysfunction|Participants without renal dysfunction who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
307494|NCT01227395|O1|Outcome|Azithromycin With Renal Dysfunction|Participants with renal dysfunction who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
307495|NCT01227395|O2|Outcome|Azithromycin Without Concomitant Drugs|Participants without concomitant drugs who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
307496|NCT01227395|O1|Outcome|Azithromycin With Concomitant Drugs|Participants with concomitant drugs who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
307497|NCT01227395|O2|Outcome|Female|Female Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
307498|NCT01227395|O1|Outcome|Male|Male Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
307499|NCT01227395|O2|Outcome|>=65 Years|Participants with >=65 years who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
307500|NCT01227395|O1|Outcome|<65 Years|Participants with <65 years who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
307501|NCT01227395|O2|Outcome|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
307502|NCT01227395|O1|Outcome|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
307503|NCT01227395|O2|Outcome|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
307504|NCT01227395|O1|Outcome|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
307505|NCT01227395|E2|Reported Event|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
307506|NCT01227395|E1|Reported Event|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
307507|NCT01227382|B1|Baseline|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
307508|NCT01227382|P1|Participant Flow|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
307509|NCT01227382|O1|Outcome|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
307510|NCT01227382|O1|Outcome|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
307511|NCT01227382|O1|Outcome|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
307512|NCT01227382|O1|Outcome|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
307513|NCT01227382|O1|Outcome|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
307514|NCT01227382|O1|Outcome|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
307515|NCT01227382|O1|Outcome|Diagnostic Accuracy of SpyBite Biopsy Forceps Compared to the|Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
307516|NCT01227382|E1|Reported Event|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
307517|NCT01227278|B3|Baseline|Total|Total of all reporting groups
307518|NCT01227278|B2|Baseline|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
307519|NCT01227278|B1|Baseline|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
307520|NCT01227278|P2|Participant Flow|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
307521|NCT01227278|P1|Participant Flow|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
307522|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
307523|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
307524|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
307525|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
307526|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
307527|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
307528|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
307529|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
307530|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
307531|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
307532|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
307533|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
307534|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
307535|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
307536|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
307537|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
307538|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
307539|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
307540|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
307541|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
307542|NCT01227278|E2|Reported Event|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
307543|NCT01227278|E1|Reported Event|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
307544|NCT01227265|B4|Baseline|Total|Total of all reporting groups
307545|NCT01227265|B3|Baseline|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
307546|NCT01227265|B2|Baseline|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
307547|NCT01227265|B1|Baseline|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
307548|NCT01227265|P3|Participant Flow|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
307549|NCT01227265|P2|Participant Flow|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
307550|NCT01227265|P1|Participant Flow|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
307551|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
307552|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
307553|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
307554|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
307555|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
307556|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
307557|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
307558|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
307559|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
307560|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
307561|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
307562|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
307563|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
307564|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
307565|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
307566|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
307567|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
307568|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
307569|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
307570|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
307571|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
307572|NCT01227265|E3|Reported Event|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
307573|NCT01227265|E2|Reported Event|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
307574|NCT01227265|E1|Reported Event|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
307575|NCT01227057|B3|Baseline|Total|Total of all reporting groups
307576|NCT01227057|B2|Baseline|Arm 2: Case Management|Case Management: Case management
307577|NCT01227057|B1|Baseline|Arm 1: Cognitive Rehabilitation|"Cognitive rehabilitation and exposure therapy for hoarding~Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring."
307578|NCT01227057|P2|Participant Flow|Arm 2: Case Management|Case Management: Case management
307579|NCT01227057|P1|Participant Flow|Arm 1: Cognitive Rehabilitation|"Cognitive rehabilitation and exposure therapy for hoarding~Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring."
307580|NCT01227057|O2|Outcome|Arm 2: Case Management|"Case management~Case Management: Case management"
307581|NCT01227057|O1|Outcome|Arm 1: Cognitive Rehabilitation|"Cognitive rehabilitation and exposure therapy for hoarding~Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring."
307582|NCT01227057|O2|Outcome|Arm 2: Case Management|Case Management: Case management
307583|NCT01227057|O1|Outcome|Arm 1: Cognitive Rehabilitation|"Cognitive rehabilitation and exposure therapy for hoarding~Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring."
307584|NCT01227057|E2|Reported Event|Arm 2: Case Management|Case Management: Case management
307585|NCT01227057|E1|Reported Event|Arm 1: Cognitive Rehabilitation|"Cognitive rehabilitation and exposure therapy for hoarding~Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring."
307586|NCT01227018|B1|Baseline|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
307587|NCT01227018|P1|Participant Flow|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
307588|NCT01227018|O1|Outcome|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
307589|NCT01227018|O1|Outcome|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
307590|NCT01227018|O1|Outcome|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
307591|NCT01227018|O1|Outcome|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
307592|NCT01227018|O1|Outcome|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
307593|NCT01227018|E1|Reported Event|STA-9090|175 mg/m2 STA-9090 IV over 1 hour once a week for 3 weeks, followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression.
307594|NCT01227005|B3|Baseline|Total|Total of all reporting groups
307595|NCT01227005|B2|Baseline|Component Therapy|"Red blood cells, plasma, platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
307596|NCT01227005|B1|Baseline|Whole Blood|"Whole Blood plus pooled platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
307597|NCT01227005|P2|Participant Flow|Component Therapy|"Red blood cells, plasma, platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
307598|NCT01227005|P1|Participant Flow|Whole Blood|"Whole Blood plus pooled platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
307599|NCT01227005|O2|Outcome|Component Therapy|"Red blood cells, plasma, platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
307600|NCT01227005|O1|Outcome|Whole Blood|"Whole Blood plus pooled platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
307601|NCT01227005|O2|Outcome|Component Therapy|"Red blood cells, plasma, platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
307602|NCT01227005|O1|Outcome|Whole Blood|"Whole Blood plus pooled platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
307603|NCT01227005|O2|Outcome|Component Therapy|"Red blood cells, plasma, platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
307604|NCT01227005|O1|Outcome|Whole Blood|"Whole Blood plus pooled platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
307605|NCT01227005|E2|Reported Event|Component Therapy|"Red blood cells, plasma, platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
307606|NCT01227005|E1|Reported Event|Whole Blood|"Whole Blood plus pooled platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
307607|NCT01226745|B7|Baseline|Total|Total of all reporting groups
307608|NCT01226745|B6|Baseline|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307609|NCT01226745|B5|Baseline|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307610|NCT01226745|B4|Baseline|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307611|NCT01226745|B3|Baseline|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307612|NCT01226745|B2|Baseline|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307613|NCT01226745|B1|Baseline|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307614|NCT01226745|P6|Participant Flow|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307615|NCT01226745|P5|Participant Flow|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307616|NCT01226745|P4|Participant Flow|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307617|NCT01226745|P3|Participant Flow|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307618|NCT01226745|P2|Participant Flow|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307619|NCT01226745|P1|Participant Flow|ONO-4641 0.15 Milligram (mg) - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307620|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307621|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307622|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307623|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307624|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307625|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307626|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307627|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307628|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307629|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307630|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307631|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307632|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307633|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307634|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307635|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307636|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307637|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307638|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307639|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307640|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307641|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307642|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307643|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307644|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307645|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307646|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307647|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307648|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307649|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307650|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307651|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307652|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307653|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307654|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307655|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307656|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307657|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307658|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307659|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307660|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307661|NCT01226745|O1|Outcome|ONO-4641 0.15 Milligram (mg) - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307662|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307663|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307664|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307665|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307666|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307667|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307668|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307669|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307670|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307671|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307672|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307673|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307674|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307675|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307676|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307677|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307678|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307679|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307680|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307681|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307682|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307683|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307684|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307685|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307686|NCT01226745|E6|Reported Event|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307687|NCT01226745|E5|Reported Event|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307688|NCT01226745|E4|Reported Event|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307689|NCT01226745|E3|Reported Event|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
307690|NCT01226745|E2|Reported Event|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
307691|NCT01226745|E1|Reported Event|ONO-4641 0.15 Milligram (mg) - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
307692|NCT01226732|B7|Baseline|Total|Total of all reporting groups
307693|NCT01226732|B6|Baseline|Dose Level 6|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
307694|NCT01226732|B5|Baseline|Dose Level 5|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
307695|NCT01226732|B4|Baseline|Dose Level 4|"Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
307696|NCT01226732|B3|Baseline|Dose Level 3|"Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
307697|NCT01226732|B2|Baseline|Dose Level 2|"Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
307698|NCT01226732|B1|Baseline|Dose Level 1|"Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
307699|NCT01226732|P6|Participant Flow|Dose Level 6|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
307700|NCT01226732|P5|Participant Flow|Dose Level 5|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
307701|NCT01226732|P4|Participant Flow|Dose Level 4|"Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
307702|NCT01226732|P3|Participant Flow|Dose Level 3|"Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
307703|NCT01226732|P2|Participant Flow|Dose Level 2|"Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
307704|NCT01226732|P1|Participant Flow|Dose Level 1|"Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
307705|NCT01226732|O1|Outcome|All Patients|The Response Rate is determined for all patients
307706|NCT01226732|O6|Outcome|Dose Level 6|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
307707|NCT01226732|O5|Outcome|Dose Level 5|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
307708|NCT01226732|O4|Outcome|Dose Level 4|"Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
307709|NCT01226732|O3|Outcome|Dose Level 3|"Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
307710|NCT01226732|O2|Outcome|Dose Level 2|"Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
307711|NCT01226732|O1|Outcome|Dose Level 1|"Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
307712|NCT01226732|O1|Outcome|All Patients|The Maximum Tolerated Dose (MTD) is determined for all patients
307713|NCT01226732|E6|Reported Event|Dose Level 6|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
307714|NCT01226732|E5|Reported Event|Dose Level 5|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
307715|NCT01226732|E4|Reported Event|Dose Level 4|"Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
307716|NCT01226732|E3|Reported Event|Dose Level 3|"Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
307717|NCT01226732|E2|Reported Event|Dose Level 2|"Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
307718|NCT01226732|E1|Reported Event|Dose Level 1|"Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
307719|NCT01226719|B1|Baseline|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
307720|NCT01226719|P1|Participant Flow|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
307721|NCT01226719|O1|Outcome|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
307722|NCT01226719|O1|Outcome|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
307723|NCT01226719|O1|Outcome|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
307724|NCT01226719|O1|Outcome|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
307725|NCT01226719|O1|Outcome|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
307726|NCT01226719|E1|Reported Event|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
307727|NCT01226706|B3|Baseline|Total|Total of all reporting groups
307728|NCT01226706|B2|Baseline|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307729|NCT01226706|B1|Baseline|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307730|NCT01226706|P2|Participant Flow|Botulinum Toxin Type A|Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
307731|NCT01226706|P1|Participant Flow|Placebo|normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
307732|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307733|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307734|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307923|NCT01226043|O2|Outcome|Vial and Syringe|Patients using Vial and Syringe during the re-randomization phase.
307735|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307736|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307737|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307738|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307739|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307740|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307741|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307742|NCT01226706|O2|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
307743|NCT01226706|O1|Outcome|Placebo|normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
307744|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307745|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307746|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307747|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307748|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307749|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307750|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307751|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307752|NCT01226706|O2|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
307753|NCT01226706|O1|Outcome|Placebo|normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
307754|NCT01226706|O2|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
307755|NCT01226706|O1|Outcome|Placebo|normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
307756|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307757|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307758|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307759|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307760|NCT01226706|O2|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
307761|NCT01226706|O1|Outcome|Placebo|normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
307762|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307763|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307764|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307765|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307766|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307767|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307768|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307769|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307770|NCT01226706|O2|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
307771|NCT01226706|O1|Outcome|Placebo|normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
307772|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307773|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307774|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307775|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307776|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307777|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307778|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307779|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307780|NCT01226706|O2|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
307781|NCT01226706|O1|Outcome|Placebo|normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
307782|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307783|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307784|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307785|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307786|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307787|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307788|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307789|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307790|NCT01226706|O2|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
307791|NCT01226706|O1|Outcome|Placebo|normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
307792|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307793|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307794|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307795|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307796|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307797|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307924|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients using SoloSTAR® pen during the re-randomization phase.
307798|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307799|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307800|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307801|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307802|NCT01226706|O2|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
307803|NCT01226706|O1|Outcome|Placebo|normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
307804|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307805|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307806|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1~botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
307807|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,~Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
307808|NCT01226706|O2|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
307809|NCT01226706|O1|Outcome|Placebo|normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
307810|NCT01226706|E2|Reported Event|Botulinum Toxin Type A|Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
307811|NCT01226706|E1|Reported Event|Placebo|normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
307812|NCT01226511|B3|Baseline|Total|Total of all reporting groups
307813|NCT01226511|B2|Baseline|Placebo/Duloxetine|"Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.~Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period."
307814|NCT01226511|B1|Baseline|Duloxetine/Duloxetine|"Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.~Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period."
307815|NCT01226511|P2|Participant Flow|Placebo/Duloxetine|"Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.~Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period."
307816|NCT01226511|P1|Participant Flow|Duloxetine/Duloxetine|"Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.~Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period."
307817|NCT01226511|O2|Outcome|Placebo/Duloxetine (Extension Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
307818|NCT01226511|O1|Outcome|Duloxetine/Duloxetine (Extension Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
307819|NCT01226511|O2|Outcome|Placebo/Duloxetine (Extension Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
307820|NCT01226511|O1|Outcome|Duloxetine/Duloxetine (Extension Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
307821|NCT01226511|O2|Outcome|Placebo/Duloxetine (Extension Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
307822|NCT01226511|O1|Outcome|Duloxetine/Duloxetine (Extension Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
307823|NCT01226511|O2|Outcome|Placebo/Duloxetine (Extension Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
307824|NCT01226511|O1|Outcome|Duloxetine/Duloxetine (Extension Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
307825|NCT01226511|O2|Outcome|Placebo/Duloxetine (Extension Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
307826|NCT01226511|O1|Outcome|Duloxetine/Duloxetine (Extension Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
307827|NCT01226511|O2|Outcome|Placebo/Duloxetine (Extension Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
307828|NCT01226511|O1|Outcome|Duloxetine/Duloxetine (Extension Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
307829|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
307830|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
307831|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
307832|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
307833|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
307834|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
307835|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
307836|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
307837|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
307838|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
307839|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
307840|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
307841|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
307842|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
307843|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
307844|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
307845|NCT01226511|E6|Reported Event|Placebo-Taper|AEs during the taper period for participants who were dispensed placebo prior to entering the taper phase. Participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period.
307846|NCT01226511|E5|Reported Event|Duloxetine-Taper|AEs during the taper period for participants who were dispensed duloxetine prior to entering the taper phase. Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period.
307847|NCT01226511|E4|Reported Event|Placebo/Duloxetine-Extension Treatment|AEs during the extension treatment period for participants who received placebo capsules orally, QD during the acute treatment period (10 weeks) and flexible doses of duloxetine 30 to 120 mg orally, QD during the extension treatment period (up to 18 weeks).
307848|NCT01226511|E3|Reported Event|Duloxetine/Duloxetine-Extension Treatment|AEs during the extension treatment period for participants who received flexible doses of duloxetine 30 to 120 mg orally, QD during both the acute and extension treatment periods (up to 28 weeks).
307849|NCT01226511|E2|Reported Event|Placebo|AEs during the acute treatment period for participants who received placebo capsules orally, QD for 10 weeks.
307850|NCT01226511|E1|Reported Event|Duloxetine|Adverse events (AEs) during the acute treatment period for participants who received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks.
307851|NCT01226459|B3|Baseline|Total|Total of all reporting groups
307852|NCT01226459|B2|Baseline|Minoxidil Foam|"5% Minoxidil Topical Foam~5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
308168|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
307853|NCT01226459|B1|Baseline|Vehicle Foam|"Vehicle Topical Foam~Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
307854|NCT01226459|P2|Participant Flow|Minoxidil Foam|"5% Minoxidil Topical Foam~5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
307855|NCT01226459|P1|Participant Flow|Vehicle Foam|"Vehicle Topical Foam~Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
307856|NCT01226459|O2|Outcome|Minoxidil Foam|"5% Minoxidil Topical Foam~5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
307857|NCT01226459|O1|Outcome|Vehicle Foam|"Vehicle Topical Foam~Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
307858|NCT01226459|O2|Outcome|Minoxidil Foam|"5% Minoxidil Topical Foam~5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
307859|NCT01226459|O1|Outcome|Vehicle Foam|"Vehicle Topical Foam~Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
307860|NCT01226459|O2|Outcome|Minoxidil Foam|"5% Minoxidil Topical Foam~5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
307861|NCT01226459|O1|Outcome|Vehicle Foam|"Vehicle Topical Foam~Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
307862|NCT01226459|E2|Reported Event|Minoxidil Foam|"5% Minoxidil Topical Foam~5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
307863|NCT01226459|E1|Reported Event|Vehicle Foam|"Vehicle Topical Foam~Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
307864|NCT01226420|B1|Baseline|Alefacept|Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
307865|NCT01226420|P1|Participant Flow|Alefacept|Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
307866|NCT01226420|O1|Outcome|Alefacept|Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
307867|NCT01226420|O1|Outcome|Alefacept|Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
307868|NCT01226420|E1|Reported Event|Alefacept|Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
307869|NCT01226121|B4|Baseline|Total|Total of all reporting groups
307870|NCT01226121|B3|Baseline|Day 4 Manipulation|Finger manipulation four days following collagenase injection
307871|NCT01226121|B2|Baseline|Day 2 Manipulation|Finger manipulation two days following collagenase injection
307872|NCT01226121|B1|Baseline|Day 1 Manipulation|Finger manipulation one day following collagenase injection
307873|NCT01226121|P3|Participant Flow|Day 4 Manipulation|Finger manipulation four days following collagenase injection
307874|NCT01226121|P2|Participant Flow|Day 2 Manipulation|Finger manipulation two days following collagenase injection
307875|NCT01226121|P1|Participant Flow|Day 1 Manipulation|Finger manipulation one day following collagenase injection
307876|NCT01226121|O3|Outcome|Day 4 Manipulation|Finger manipulation four days following collagenase injection
307877|NCT01226121|O2|Outcome|Day 2 Manipulation|Finger manipulation two days following collagenase injection
307878|NCT01226121|O1|Outcome|Day 1 Manipulation|Finger manipulation one day following collagenase injection
307879|NCT01226121|O3|Outcome|Day 4 Manipulation|Finger manipulation four days following collagenase injection
307880|NCT01226121|O2|Outcome|Day 2 Manipulation|Finger manipulation two days following collagenase injection
307881|NCT01226121|O1|Outcome|Day 1 Manipulation|Finger manipulation one day following collagenase injection
307882|NCT01226121|E3|Reported Event|Day 4 Manipulation|Finger manipulation four days following collagenase injection
307883|NCT01226121|E2|Reported Event|Day 2 Manipulation|Finger manipulation two days following collagenase injection
307884|NCT01226121|E1|Reported Event|Day 1 Manipulation|Finger manipulation one day following collagenase injection
307885|NCT01226095|B1|Baseline|Brufen Retard|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
307886|NCT01226095|P1|Participant Flow|Brufen Retard|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
307887|NCT01226095|O1|Outcome|Brufen Retard|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
307888|NCT01226095|O3|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
307889|NCT01226095|O2|Outcome|Brufen Retard (Visit 2, Week 2)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.
307890|NCT01226095|O1|Outcome|Brufen Retard Baseline (Visit 1)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis prior to administration of Brufen Retard (open-label ibuprofen sustained release form) at Baseline per the Prescribing Information.
307925|NCT01226043|O4|Outcome|Vial and Syringe (Period 1)|Patients using Vial and Syringe during period 1 of the crossover phase.
308169|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
307891|NCT01226095|O2|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
307892|NCT01226095|O1|Outcome|Brufen Retard (Visit 2, Week 2)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.
307893|NCT01226095|O1|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
307894|NCT01226095|O3|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
307895|NCT01226095|O2|Outcome|Brufen Retard (Visit 2, Week 2)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.
307896|NCT01226095|O1|Outcome|Brufen Retard Baseline (Visit 1)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis prior to administration of Brufen Retard (open-label ibuprofen sustained release form) at Baseline per the Prescribing Information.
307897|NCT01226095|O2|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
307898|NCT01226095|O1|Outcome|Brufen Retard (Visit 2, Week 2)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.
307899|NCT01226095|O3|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
307900|NCT01226095|O2|Outcome|Brufen Retard (Visit 2, Week 2)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.
307901|NCT01226095|O1|Outcome|Brufen Retard Baseline (Visit 1)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis prior to administration of Brufen Retard (open-label ibuprofen sustained release form) at Baseline per the Prescribing Information.
307902|NCT01226095|O3|Outcome|Brufen Retard (All Visits)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information throughout this post-marketing observational study.
307903|NCT01226095|O2|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
307904|NCT01226095|O1|Outcome|Brufen Retard (Visit 2, Week 2)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.
307905|NCT01226095|O2|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
307906|NCT01226095|O1|Outcome|Brufen Retard Baseline (Visit 1)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis prior to administration of Brufen Retard (open-label ibuprofen sustained release form) at Baseline per the Prescribing Information.
307907|NCT01226095|E1|Reported Event|Brufen Retard|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
307908|NCT01226043|B3|Baseline|Total|Total of all reporting groups
307909|NCT01226043|B2|Baseline|Crossover Phase: Vial & Syringe / Pen|Patients randomized to the sequence: Lantus vial and syringe in Period 1 and Lantus SoloSTAR pen in Period 2 for the 4-week crossover phase.
307910|NCT01226043|B1|Baseline|Crossover Phase: Pen / Vial & Syringe|Patients randomized to the sequence: Lantus SoloSTAR pen in Period 1 and Lantus vial and syringe in Period 2 for the 4-week crossover phase.
307911|NCT01226043|P4|Participant Flow|Vial and Syringe|Re-randomization phase and the observational phase: patients randomized to Lantus Vial and Syringe.
307912|NCT01226043|P3|Participant Flow|SoloSTAR® Pen|Re-randomization phase and the observational phase: patients randomized to Lantus SoloSTAR® pen.
307913|NCT01226043|P2|Participant Flow|Vial &Syringe (Period 1) / Pen (Period 2)|Crossover phase: patients randomized to the sequence: Lantus vial and syringe in Period 1 and Lantus SoloSTAR pen in Period 2.
307914|NCT01226043|P1|Participant Flow|Pen (Period 1) / Vial & Syringe (Period 2)|Crossover phase: patients randomized to the sequence: Lantus SoloSTAR® pen in Period 1 and Lantus vial and syringe in Period 2.
307915|NCT01226043|O6|Outcome|Observational Phase: Vial and Syringe|Patients using Vial and Syringe during the Observational phase (from Week 10 to Week 40)
307916|NCT01226043|O5|Outcome|Observational Phase: SoloSTAR® Pen|Patients using SoloSTAR® Pen during the Observational phase (from Week 10 to Week 40)
307917|NCT01226043|O4|Outcome|Re-randomization Phase: Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization period (Week 4 to Week 10)
307918|NCT01226043|O3|Outcome|Re-randomization Phase: SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization period (Week 4 to Week 10)
307919|NCT01226043|O2|Outcome|Crossover Phase: Vial and Syringe|Patients using Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
307920|NCT01226043|O1|Outcome|Crossover Phase: SoloSTAR® Pen|Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
307921|NCT01226043|O2|Outcome|Vial and Syringe|Patients using Vial and Syringe during the observational phase.
307922|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients using SoloSTAR® pen during the observational phase.
307926|NCT01226043|O3|Outcome|SoloSTAR® Pen (Period 2)|Patients using SoloSTAR® pen during period 2 of the crossover phase.
307927|NCT01226043|O2|Outcome|Vial and Syringe (Period 2)|Patients using Vial and Syringe during period 2 of the crossover phase.
307928|NCT01226043|O1|Outcome|SoloSTAR® Pen (Period 1)|Patients using SoloSTAR® pen during period 1 of the crossover phase.
307929|NCT01226043|O2|Outcome|Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization phase (from Week 4 to Week 10) and the Observational phase (from Week 10 to Week 40).
307930|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization phase (from Week 4 to Week 10) and the Observational phase (from Week 10 to Week 40).
307931|NCT01226043|O2|Outcome|Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization phase (from Week 4 to Week 10) and the Observational phase (from Week 10 to Week 40).
307932|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization phase (from Week 4 to Week 10) and the Observational phase (from Week 10 to Week 40).
307933|NCT01226043|O2|Outcome|Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization period (Week 4 to Week 10)
307934|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization period (Week 4 to Week 10)
307935|NCT01226043|O2|Outcome|Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization period (Week 4 to Week 10)
307936|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization period (Week 4 to Week 10)
307937|NCT01226043|O2|Outcome|Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization period (Week 4 to Week 10)
307938|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization period (Week 4 to Week 10)
307939|NCT01226043|O2|Outcome|Vial and Syringe|Vial and Syringe used during the crossover phase either at period 1 or at period 2
307940|NCT01226043|O1|Outcome|SoloSTAR® Pen|SoloSTAR® Pen used during the crossover phase either at period 1 or at period 2
307941|NCT01226043|O2|Outcome|Vial and Syringe|Patients using the Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
307942|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
307943|NCT01226043|O2|Outcome|Vial and Syringe|Patients using the Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
307944|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
307945|NCT01226043|E6|Reported Event|Observational Phase: Vial and Syringe|Patients using Vial and Syringe during the Observational phase (from Week 10 to Week 40)
307946|NCT01226043|E5|Reported Event|Observational Phase: SoloSTAR® Pen|Patients using SoloSTAR® Pen during the Observational phase (from Week 10 to Week 40)
307947|NCT01226043|E4|Reported Event|Re-randomization Phase: Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization period (Week 4 to Week 10)
307948|NCT01226043|E3|Reported Event|Re-randomization Phase: SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization period (Week 4 to Week 10)
307949|NCT01226043|E2|Reported Event|Crossover Phase: Vial and Syringe|Patients using Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
307950|NCT01226043|E1|Reported Event|Crossover Phase: SoloSTAR® Pen|Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
307951|NCT01225991|B1|Baseline|Milnacipran, Active Drug, Open-label|All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Subjects will be allowed to escalate up to 100 mg a day or to their maximum tolerated dose in the course of the first week: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day (25 mg twice daily); After Day 7: 100 mg/day (50 mg twice daily). The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day). Final efficacy assessments will be made at the termination visit, and the study medication will be tapered down following 12 weeks of drug treatment.
307952|NCT01225991|P1|Participant Flow|Milnacipran, Active Drug, Open-label|"All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Patients will be allowed to escalate up to 100 mg a day, or to their maximum tolerated dose in the course of the first week. The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day). Final efficacy assessments will be made at the termination visit, and the study medication will be tapered down following 12 weeks of drug treatment.~Milnacipran: All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Patients will be allowed to escalate up to 100 mg a day: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day"
307953|NCT01225991|O1|Outcome|Milnacipran, Active Drug, Open-label|All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Subjects will be allowed to escalate up to 100 mg a day or to their maximum tolerated dose in the course of the first week: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day (25 mg twice daily); After Day 7: 100 mg/day (50 mg twice daily). The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day). Final efficacy assessments will be made at the termination visit, and the study medication will be tapered down following 12 weeks of drug treatment.
307978|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
307954|NCT01225991|O1|Outcome|Milnacipran, Active Drug, Open-label|All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Subjects will be allowed to escalate up to 100 mg a day or to their maximum tolerated dose in the course of the first week: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day (25 mg twice daily); After Day 7: 100 mg/day (50 mg twice daily). The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day). Final efficacy assessments will be made at the termination visit, and the study medication will be tapered down following 12 weeks of drug treatment.
307955|NCT01225991|O1|Outcome|Milnacipran, Active Drug, Open-label|All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Subjects will be allowed to escalate up to 100 mg a day or to their maximum tolerated dose in the course of the first week: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day (25 mg twice daily); After Day 7: 100 mg/day (50 mg twice daily). The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day). Final efficacy assessments will be made at the termination visit, and the study medication will be tapered down following 12 weeks of drug treatment.
307956|NCT01225991|O1|Outcome|Milnacipran, Active Drug, Open-label|All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Subjects will be allowed to escalate up to 100 mg a day or to their maximum tolerated dose in the course of the first week: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day (25 mg twice daily); After Day 7: 100 mg/day (50 mg twice daily). The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day). Final efficacy assessments will be made at the termination visit, and the study medication will be tapered down following 12 weeks of drug treatment.
307957|NCT01225991|O1|Outcome|Milnacipran, Active Drug, Open-label|All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Subjects will be allowed to escalate up to 100 mg a day or to their maximum tolerated dose in the course of the first week: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day (25 mg twice daily); After Day 7: 100 mg/day (50 mg twice daily). The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day). Final efficacy assessments will be made at the termination visit, and the study medication will be tapered down following 12 weeks of drug treatment.
307958|NCT01225991|E1|Reported Event|Milnacipran, Active Drug, Open-label|All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Subjects will be allowed to escalate up to 100 mg a day or to their maximum tolerated dose in the course of the first week: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day (25 mg twice daily); After Day 7: 100 mg/day (50 mg twice daily). The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day). Final efficacy assessments will be made at the termination visit, and the study medication will be tapered down following 12 weeks of drug treatment.
307959|NCT01225952|B4|Baseline|Total|Total of all reporting groups
307960|NCT01225952|B3|Baseline|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
307961|NCT01225952|B2|Baseline|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
307962|NCT01225952|B1|Baseline|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
307963|NCT01225952|P3|Participant Flow|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
307964|NCT01225952|P2|Participant Flow|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
307965|NCT01225952|P1|Participant Flow|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
307966|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
307967|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
307968|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
307969|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
307970|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
307971|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
307972|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
307973|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
307974|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
307975|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
307976|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
307977|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
307979|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
307980|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
307981|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
307982|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
307983|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
307984|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
307985|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
307986|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
307987|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
307988|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
307989|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
307990|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
307991|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
307992|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
307993|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
307994|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
307995|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
307996|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
307997|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
307998|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
307999|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
308000|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
308001|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
308002|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
308003|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
308004|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
308005|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
308006|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
308007|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
308008|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
308009|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
308010|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
308011|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
308012|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
308013|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
308014|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
308015|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
308016|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
308017|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
308018|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
308019|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
308020|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
308021|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
308022|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
308023|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
308024|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
308025|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
308026|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
308027|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
308028|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
308029|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
308030|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
308031|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
308032|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
308033|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
308034|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
308035|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
308036|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
308037|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
308038|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
308039|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
308040|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
308041|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
308042|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
308043|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
308044|NCT01225952|E3|Reported Event|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
308045|NCT01225952|E2|Reported Event|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
308046|NCT01225952|E1|Reported Event|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
308047|NCT01225926|B3|Baseline|Total|Total of all reporting groups
308048|NCT01225926|B2|Baseline|IQ SN60WF|AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
308049|NCT01225926|B1|Baseline|Toric T3 - T9|AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
308050|NCT01225926|P2|Participant Flow|IQ SN60WF|AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
308051|NCT01225926|P1|Participant Flow|Toric T3 - T9|AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
308052|NCT01225926|O2|Outcome|IQ SN60WF|AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
308053|NCT01225926|O1|Outcome|Toric T3 - T9|AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
308054|NCT01225926|E2|Reported Event|IQ SN60WF|AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
308055|NCT01225926|E1|Reported Event|Toric T3 - T9|AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
308056|NCT01225887|B1|Baseline|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Nintedanib: Given PO"
308057|NCT01225887|P1|Participant Flow|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Nintedanib: Given PO"
308058|NCT01225887|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Nintedanib: Given PO"
308059|NCT01225887|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Nintedanib: Given PO"
308060|NCT01225887|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Nintedanib: Given PO"
308061|NCT01225887|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Nintedanib: Given PO"
308062|NCT01225887|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Nintedanib: Given PO"
308063|NCT01225887|E1|Reported Event|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Nintedanib: Given PO"
308064|NCT01225835|B3|Baseline|Total|Total of all reporting groups
308065|NCT01225835|B2|Baseline|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308066|NCT01225835|B1|Baseline|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308067|NCT01225835|P2|Participant Flow|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308068|NCT01225835|P1|Participant Flow|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308069|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308070|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308071|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308072|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308073|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308074|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308075|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308076|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308077|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308078|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308079|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308080|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308147|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
308148|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
308081|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308082|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308083|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308084|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308085|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308086|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308087|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308088|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308089|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308090|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308091|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308092|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308093|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308094|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308095|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308096|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308097|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308098|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308149|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
308150|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
308099|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308100|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308101|NCT01225835|O1|Outcome|All Participants|The analysis of whether progesterone level is a predictor for ongoing pregnancy used all participants.
308102|NCT01225835|O6|Outcome|Follitrophin Alpha: Stratum Age >=39 Yrs|The subset of participants in the follitrophin alpha treatment arm who were >= 39 years old.
308103|NCT01225835|O5|Outcome|Follitrophin Alpha: Stratum Age <39 Yrs|The subset of participants in the follitrophin alpha treatment arm who were < 39 years old.
308104|NCT01225835|O4|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308105|NCT01225835|O3|Outcome|Menotrophin: Stratum Age >=39 Yrs|The subset of participants in the menotrophin treatment arm who were >= 39 years old.
308106|NCT01225835|O2|Outcome|Menotrophin: Stratum Age <39 Yrs|The subset of participants in the menotrophin treatment arm who were < 39 years old.
308107|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308108|NCT01225835|E2|Reported Event|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 13 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308109|NCT01225835|E1|Reported Event|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 13 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
308110|NCT01225822|B6|Baseline|Total|Total of all reporting groups
308111|NCT01225822|B5|Baseline|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
308112|NCT01225822|B4|Baseline|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
308113|NCT01225822|B3|Baseline|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
308114|NCT01225822|B2|Baseline|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
308115|NCT01225822|B1|Baseline|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
308116|NCT01225822|P5|Participant Flow|Enoxaparin 40 mg qd|Enoxaparin 40 qd (once daily) subcutaneous injection
308117|NCT01225822|P4|Participant Flow|BIBR 1048 300 mg qd|Dabigatran 300 mg qd(once daily) oral
308118|NCT01225822|P3|Participant Flow|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid(twice daily) oral
308119|NCT01225822|P2|Participant Flow|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid(twice daily) oral
308120|NCT01225822|P1|Participant Flow|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid(twice daily) oral
308121|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
308122|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
308123|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
308124|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
308125|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
308126|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
308127|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
308128|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
308129|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
308130|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
308131|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
308132|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
308133|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
308134|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
308135|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
308136|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
308137|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
308138|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
308139|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 50 mg bid (twice daily) oral
308140|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
308141|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
308142|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
308143|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
308144|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
308145|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
308146|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
308170|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
308171|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
308172|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
308173|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
308174|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
308175|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
308176|NCT01225822|E5|Reported Event|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
308177|NCT01225822|E4|Reported Event|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
308178|NCT01225822|E3|Reported Event|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
308179|NCT01225822|E2|Reported Event|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
308180|NCT01225822|E1|Reported Event|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
308181|NCT01225731|B6|Baseline|Total|Total of all reporting groups
308182|NCT01225731|B5|Baseline|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
308183|NCT01225731|B4|Baseline|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
308184|NCT01225731|B3|Baseline|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
308185|NCT01225731|B2|Baseline|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
308186|NCT01225731|B1|Baseline|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
308187|NCT01225731|P13|Participant Flow|Part 3: Tildrakizumab 200 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
308188|NCT01225731|P12|Participant Flow|Part 3: Tildrakizumab 100 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
308189|NCT01225731|P11|Participant Flow|Part 3: Tildrakizumab 25 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
308190|NCT01225731|P10|Participant Flow|Part 3: Tildrakizumab 5 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
308191|NCT01225731|P9|Participant Flow|Part 2: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks
308192|NCT01225731|P8|Participant Flow|Part 2: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
308193|NCT01225731|P7|Participant Flow|Part 2: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
308194|NCT01225731|P6|Participant Flow|Part 2: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
308195|NCT01225731|P5|Participant Flow|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
308196|NCT01225731|P4|Participant Flow|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
308197|NCT01225731|P3|Participant Flow|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
308198|NCT01225731|P2|Participant Flow|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
308199|NCT01225731|P1|Participant Flow|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
308200|NCT01225731|O9|Outcome|Part 2: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks
308201|NCT01225731|O8|Outcome|Part 2: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
308202|NCT01225731|O7|Outcome|Part 2: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
308203|NCT01225731|O6|Outcome|Part 2: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
308204|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
308205|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
308206|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
308207|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
308208|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
308209|NCT01225731|O13|Outcome|Part 3: Tildrakizumab 200 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug
308210|NCT01225731|O12|Outcome|Part 3: Tildrakizumab 100 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug
308211|NCT01225731|O11|Outcome|Part 3: Tildrakizumab 25 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug
308212|NCT01225731|O10|Outcome|Part 3: Tildrakizumab 5 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug
308213|NCT01225731|O9|Outcome|Part 2: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks
308214|NCT01225731|O8|Outcome|Part 2: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
308215|NCT01225731|O7|Outcome|Part 2: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
308216|NCT01225731|O6|Outcome|Part 2: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
308217|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
308218|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
308219|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
308220|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
308221|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
308222|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
308223|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
308224|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
308225|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
308226|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
308227|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
308228|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
308229|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
308230|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
308231|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
308232|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
308233|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
308234|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
308235|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
308236|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
308237|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
308238|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
308239|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
308240|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
308241|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
308242|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
308243|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
308244|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
308245|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
308246|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
308247|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
308248|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
308249|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
308250|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
308251|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
308252|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
308253|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
308254|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
308255|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
308256|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
308257|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
308258|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
308259|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
308260|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
308261|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
308262|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
308263|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
308264|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
308265|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
308266|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
308267|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
308268|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
308269|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
308270|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
308271|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
308272|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
308273|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
308274|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
308275|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
308276|NCT01225731|E14|Reported Event|Placebo Follow-up|Participants who received placebo in Part 1 and did not receive additional therapy.
308277|NCT01225731|E13|Reported Event|Part 3: Tildrakizumab 200 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
308278|NCT01225731|E12|Reported Event|Part 3: Tildrakizumab 100 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
308279|NCT01225731|E11|Reported Event|Part 3: Tildrakizumab 25 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
308280|NCT01225731|E10|Reported Event|Part 3: Tildrakizumab 5 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
308281|NCT01225731|E9|Reported Event|Part 2: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks
308282|NCT01225731|E8|Reported Event|Part 2: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
308283|NCT01225731|E7|Reported Event|Part 2: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
308284|NCT01225731|E6|Reported Event|Part 2: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
308285|NCT01225731|E5|Reported Event|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
308286|NCT01225731|E4|Reported Event|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
308287|NCT01225731|E3|Reported Event|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
308288|NCT01225731|E2|Reported Event|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
308289|NCT01225731|E1|Reported Event|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
308290|NCT01225562|B4|Baseline|Total|Total of all reporting groups
308291|NCT01225562|B3|Baseline|Placebo|Matching placebo
308292|NCT01225562|B2|Baseline|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
308293|NCT01225562|B1|Baseline|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
308294|NCT01225562|P3|Participant Flow|Placebo|Matching placebo
308295|NCT01225562|P2|Participant Flow|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
308296|NCT01225562|P1|Participant Flow|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
308297|NCT01225562|O3|Outcome|Placebo|Matching placebo
308298|NCT01225562|O2|Outcome|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
308299|NCT01225562|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
308300|NCT01225562|O3|Outcome|Placebo|Matching placebo
308301|NCT01225562|O2|Outcome|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
308302|NCT01225562|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
308303|NCT01225562|O3|Outcome|Placebo|Matching placebo
308304|NCT01225562|O2|Outcome|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
308305|NCT01225562|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
308306|NCT01225562|O3|Outcome|Placebo|Matching placebo
308307|NCT01225562|O2|Outcome|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
308308|NCT01225562|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
308309|NCT01225562|E3|Reported Event|Ticagrelor 90mg bd|
308310|NCT01225562|E2|Reported Event|Ticagrelor 60mg bd|
308311|NCT01225562|E1|Reported Event|Placebo|
308312|NCT01225549|B1|Baseline|Baseline Total|Total number of patients randomised and treated in the study
308313|NCT01225549|P10|Participant Flow|PCBA|Placebo followed by budesonide 200 µg bid followed by AZD5423 300 µg od followed by AZD5423 75 µg
308314|NCT01225549|P9|Participant Flow|PCAB|Placebo followed by budesonide 200 µg bid followed by AZD5423 75 µg followed by AZD5423 300 µg od
308315|NCT01225549|P8|Participant Flow|PBAC|Placebo followed by AZD5423 300 µg od followed by AZD5423 75 µg followed by budesonide 200 µg bid
308316|NCT01225549|P7|Participant Flow|CBPA|Budesonide 200 µg bid followed by AZD5423 300 µg od followed by placebo followed by AZD5423 75 µg
308317|NCT01225549|P6|Participant Flow|CBAP|Budesonide 200 µg bid followed by AZD5423 300 µg od followed by AZD5423 75 µg followed by placebo
308318|NCT01225549|P5|Participant Flow|CAPB|Budesonide 200 µg bid followed by AZD5423 75 µg followed by placebo followed by AZD5423 300 µg od
308319|NCT01225549|P4|Participant Flow|BPCA|AZD5423 300 µg od followed by placebo followed by budesonide 200 µg bid followed by AZD5423 75 µg
308320|NCT01225549|P3|Participant Flow|BACP|AZD5423 300 µg od followed by AZD5423 75 µg followed by budesonide 200 µg bid followed by placebo
308321|NCT01225549|P2|Participant Flow|APBC|AZD5423 75 µg followed by placebo followed by AZD5423 300 µg od followed by budesonide 200 µg bid
308322|NCT01225549|P1|Participant Flow|ACBP|AZD5423 75 µg followed by budesonide 200 µg bid followed by AZD5423 300 µg od followed by placebo
308323|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
308324|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
308325|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
308326|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
308327|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
308328|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
308329|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
308330|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
308331|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
308332|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
308333|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
308334|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
308335|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
308336|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
308337|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
308338|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
308339|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
308340|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
308341|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
308342|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
308343|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
308344|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
308345|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
308346|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
308347|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
308348|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
308349|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
308350|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
308351|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
308352|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
308353|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
308354|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
308355|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
308356|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
308357|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
308358|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
308359|NCT01225549|E4|Reported Event|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
308360|NCT01225549|E3|Reported Event|Arm 3 - 2x200ug Budesonide|2x200ug budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
308361|NCT01225549|E2|Reported Event|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
308362|NCT01225549|E1|Reported Event|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
308363|NCT01225354|B1|Baseline|Calcium Hydroxylapatite|Subject will be treated at baseline and, if needed, at 2 weeks.
308364|NCT01225354|P1|Participant Flow|Calcium Hydroxylapatite|Subject will be treated at baseline and, if needed, at 2 weeks.
308365|NCT01225354|O1|Outcome|Calcium Hydroxylapatite|Subject will be treated at baseline and, if needed, at 2 weeks.
308366|NCT01225354|O1|Outcome|Calcium Hydroxylapatite|Subject will be treated at baseline and, if needed, at 2 weeks.
308367|NCT01225354|E1|Reported Event|Calcium Hydroxylapatite|Subject will be treated at baseline and, if needed, at 2 weeks.
308368|NCT01225289|B3|Baseline|Total|Total of all reporting groups
308369|NCT01225289|B2|Baseline|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
308370|NCT01225289|B1|Baseline|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
308371|NCT01225289|P2|Participant Flow|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
308372|NCT01225289|P1|Participant Flow|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
308373|NCT01225289|O2|Outcome|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
308374|NCT01225289|O1|Outcome|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
308375|NCT01225289|O2|Outcome|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
308376|NCT01225289|O1|Outcome|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
308377|NCT01225289|O2|Outcome|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
308378|NCT01225289|O1|Outcome|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
308379|NCT01225289|O2|Outcome|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
308380|NCT01225289|O1|Outcome|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
308381|NCT01225289|E2|Reported Event|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
308382|NCT01225289|E1|Reported Event|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
308383|NCT01225263|B3|Baseline|Total|Total of all reporting groups
308384|NCT01225263|B2|Baseline|Placebo|Participants in this arm received placebo pills, which looked like the Simvastatin pill and Vitamin D pill. Two placebo pills were taken twice daily for 6 months
308385|NCT01225263|B1|Baseline|Simvastatin and Vitamin D|Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months.
308386|NCT01225263|P2|Participant Flow|"Placebo Sugar Pill"|Participants in this arm took placebo pills, which looked like the Simvastatin and Vitamin D. Two placebo pills were taken twice daily for 6 months.
308387|NCT01225263|P1|Participant Flow|Simvastatin and Vitamin D|Participants in this arm took Simvastatin 20 mg twice daily for 6 months plus Vitamin D3 1000 IU twice daily for 6 months.
308388|NCT01225263|O2|Outcome|Placebo|Participants in this arm received placebo pills, which looked like the Simvastatin pill and Vitamin D pill. Two placebo pills were taken twice daily for 6 months
308389|NCT01225263|O1|Outcome|Simvastatin and Vitamin D|Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months.
308390|NCT01225263|O2|Outcome|Placebo|Participants in this arm received placebo pills, which looked like the simvastatin and Vitamin D pills, taken twice daily for 6 months
308391|NCT01225263|O1|Outcome|Simvastatin and Vitamin D|Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months.
308392|NCT01225263|E2|Reported Event|Placebo|Participants in this arm received placebo pills, which looked like the simvastatin and Vitamin D pills, taken twice daily for 6 months
308393|NCT01225263|E1|Reported Event|Simvastatin and Vitamin D|Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months.
308394|NCT01225211|B11|Baseline|Total|Total of all reporting groups
308395|NCT01225211|B10|Baseline|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
308396|NCT01225211|B9|Baseline|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
308397|NCT01225211|B8|Baseline|Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308398|NCT01225211|B7|Baseline|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308399|NCT01225211|B6|Baseline|Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308400|NCT01225211|B5|Baseline|Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308401|NCT01225211|B4|Baseline|Cohort 2 and 3: Placebo (HO and HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
308402|NCT01225211|B3|Baseline|Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
308403|NCT01225211|B2|Baseline|Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
308404|NCT01225211|B1|Baseline|Cohort 1: Placebo|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14), followed by lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
308405|NCT01225211|P10|Participant Flow|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
308406|NCT01225211|P9|Participant Flow|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
308407|NCT01225211|P8|Participant Flow|Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308408|NCT01225211|P7|Participant Flow|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308409|NCT01225211|P6|Participant Flow|Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308410|NCT01225211|P5|Participant Flow|Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308411|NCT01225211|P4|Participant Flow|Cohort 2 and 3: Placebo (HO and HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
308412|NCT01225211|P3|Participant Flow|Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
308413|NCT01225211|P2|Participant Flow|Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h|Participants homozygous for the F508del-CFTR mutation received 200 milligram (mg) of lumacaftor (LUM) qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor (IVA) q12h (Day 15 through Day 21).
308414|NCT01225211|P1|Participant Flow|Cohort 1: Placebo|Participants homozygous (HO) for the F508del-CF transmembrane conductance regulator gene (CFTR) mutation received lumacaftor matched placebo once daily (qd) (Day 1 through Day 14), followed by lumacaftor matched placebo qd in combination with ivacaftor matched placebo every 12 hours (q12h) (Day 15 through Day 21).
308415|NCT01225211|O2|Outcome|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
308416|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
308417|NCT01225211|O2|Outcome|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
308418|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
308419|NCT01225211|O2|Outcome|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
308420|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
308421|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
308422|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308423|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HE) – Period 2|Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308424|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308425|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308426|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308427|NCT01225211|O2|Outcome|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
308428|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
308429|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
308430|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308431|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HE)|Participants heterozygous (HE) for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308432|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308433|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308434|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308435|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
308875|NCT01223404|O1|Outcome|Intervention: Placebo|A placebo patch and a placebo capsule were administered.
308436|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308437|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HE)|Participants heterozygous (HE) for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308438|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308439|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308440|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308441|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
308442|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308443|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HE) – Period 2|Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308444|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308445|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308446|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308447|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
308448|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308449|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HE) – Period 2|Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308450|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308451|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308452|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308453|NCT01225211|O3|Outcome|Cohort 1: Placebo – Period 2|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
308454|NCT01225211|O2|Outcome|Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
308455|NCT01225211|O1|Outcome|Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
308456|NCT01225211|O3|Outcome|Cohort 1: Placebo – Period 2|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
308457|NCT01225211|O2|Outcome|Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
308458|NCT01225211|O1|Outcome|Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
308459|NCT01225211|O2|Outcome|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
308460|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
308461|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 1|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28).
308462|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h – Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28).
308463|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd (HE) – Period 1|Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).
308464|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd (HO) – Period 1|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).
308465|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28).
308466|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28).
308467|NCT01225211|O2|Outcome|Cohort 1: Placebo – Period 1|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
308468|NCT01225211|O1|Outcome|Cohort 1: LUM 200 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
308469|NCT01225211|O2|Outcome|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
308470|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
308471|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
308472|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308473|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HE) – Period 2|Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308474|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308475|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308476|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308477|NCT01225211|O3|Outcome|Cohort 1: Placebo – Period 2|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
308478|NCT01225211|O2|Outcome|Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
308479|NCT01225211|O1|Outcome|Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
308480|NCT01225211|O2|Outcome|Cohort 4: Active Study Drug|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
308481|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
308482|NCT01225211|O10|Outcome|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308483|NCT01225211|O9|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308484|NCT01225211|O8|Outcome|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308485|NCT01225211|O7|Outcome|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308486|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
308487|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h – Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28).
308488|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd – Period 1|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).
308489|NCT01225211|O3|Outcome|Cohort 2: LUM 400 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28).
308490|NCT01225211|O2|Outcome|Cohort 2: LUM 200 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28).
308491|NCT01225211|O1|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 1|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28).
308492|NCT01225211|O5|Outcome|Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
308493|NCT01225211|O4|Outcome|Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
308494|NCT01225211|O3|Outcome|Cohort 1: Placebo – Period 2|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
308495|NCT01225211|O2|Outcome|Cohort 1: LUM 200 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
308496|NCT01225211|O1|Outcome|Cohort 1: Placebo – Period 1|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
308497|NCT01225211|E17|Reported Event|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
308498|NCT01225211|E16|Reported Event|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
308499|NCT01225211|E15|Reported Event|Cohort 2 and 3: Placebo (HO and HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
308500|NCT01225211|E14|Reported Event|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308501|NCT01225211|E13|Reported Event|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308502|NCT01225211|E12|Reported Event|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308503|NCT01225211|E11|Reported Event|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
308504|NCT01225211|E10|Reported Event|Cohort 2 and 3: Placebo (HO and HE) – Period 1|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28).
308505|NCT01225211|E9|Reported Event|Cohort 3: LUM 400 mg q12h – Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28).
308506|NCT01225211|E8|Reported Event|Cohort 2: LUM 600 mg qd – Period 1|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).
308507|NCT01225211|E7|Reported Event|Cohort 2: LUM 400 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28).
308508|NCT01225211|E6|Reported Event|Cohort 2: LUM 200 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28).
308509|NCT01225211|E5|Reported Event|Cohort 1: Placebo – Period 2|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
308510|NCT01225211|E4|Reported Event|Cohort 1: Placebo – Period 1|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
308511|NCT01225211|E3|Reported Event|Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
308512|NCT01225211|E2|Reported Event|Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
308513|NCT01225211|E1|Reported Event|Cohort 1: LUM 200 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
308514|NCT01225159|B3|Baseline|Total|Total of all reporting groups
308515|NCT01225159|B2|Baseline|Conventional Glycaemic Control (Control)|Conventional glycaemic control aims to control blood sugar less than 250 mg%. Insulin was given bolusly if the blood sugar more than 250 mg%.
308516|NCT01225159|B1|Baseline|Tight Glycaemic Control (TGC)|TGC used hyperinsulinaemic normoglycaemic clamp with modified glucose-insulin-potassium to control blood sugar. The insulin (HumulinTM R, Lilly pharma, Germany) was diluted with normal saline to the concentration 1 IU. mL-1 and was infused continuously throughout the operations at a fixed rate of 0.3 IU. kg-1.h-1 but the maximal rate was 20 IU/ h. A separate mixture of glucose 25% (A.N.B Laboratories, Thailand) 50 mL, potassium chloride (Nida pharma, Thailand) 20 mEq and magnesium sulfate (Atlantic, Thailand) 2 gm was infused at 0.75 mL.kg-1.h-1 and was adjusted to maintain blood glucose levels 80-150 mg/dL.
308517|NCT01225159|P2|Participant Flow|Conventional Glycaemic Control (Control)|"Allocated to control group (n = 100)~• Received allocated intervention (n = 100)"
308518|NCT01225159|P1|Participant Flow|Tight Glycaemic Control (TGC)|"Allocated to intensive group (n = 100)~Received allocated intervention (n = 99)~Did not receive allocated intervention: change operation (n = 1)"
308519|NCT01225159|O2|Outcome|Conventional Glycaemic Control (Control)|"Allocated to intensive group (n = 100)~• Received allocated intervention (n = 100)"
308520|NCT01225159|O1|Outcome|Tight Glycaemic Control (TGC)|"Allocated to control group (n = 100)~Received allocated intervention (n = 99)~Did not receive allocated intervention: change operation (n = 1)"
308521|NCT01225159|O2|Outcome|Conventional Glycaemic Control (Control)|"Allocated to intensive group (n = 100)~• Received allocated intervention (n = 100)"
308522|NCT01225159|O1|Outcome|Tight Glycaemic Control (TGC)|"Allocated to control group (n = 100)~Received allocated intervention (n = 99)~Did not receive allocated intervention: change operation (n = 1)"
308523|NCT01225159|E2|Reported Event|Conventional Glycaemic Control (Control)|"Allocated to intensive group (n = 100)~• Received allocated intervention (n = 100)"
308524|NCT01225159|E1|Reported Event|Tight Glycaemic Control (TGC)|"Allocated to control group (n = 100)~Received allocated intervention (n = 99)~Did not receive allocated intervention: change operation (n = 1)"
308525|NCT01225146|B3|Baseline|Total|Total of all reporting groups
308526|NCT01225146|B2|Baseline|Cohort 2|"Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.~ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
308546|NCT01225068|B1|Baseline|Milnacipran|Milnacipran : Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
308547|NCT01225068|P2|Participant Flow|Placebo|Placebo treatment group
308527|NCT01225146|B1|Baseline|Cohort 1|"Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).~Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria~ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
308528|NCT01225146|P2|Participant Flow|Treatment Naive (Cohort 2)|"Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.~ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
308529|NCT01225146|P1|Participant Flow|Treatment Experienced (Cohort 1|"Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).~Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria~ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
308530|NCT01225146|O2|Outcome|Treatment Naive (Cohort 2)|"Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.~ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
308531|NCT01225146|O1|Outcome|Treatment Experienced (Cohort 1|"Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).~Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria~ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
308532|NCT01225146|O2|Outcome|Treatment Naive (Cohort 2)|"Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.~ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
308533|NCT01225146|O1|Outcome|Treatment Experienced (Cohort 1|"Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).~Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria~ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
308534|NCT01225146|O2|Outcome|Treatment Naive (Cohort 2)|"Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.~ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
308535|NCT01225146|O1|Outcome|Treatment Experienced (Cohort 1|"Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).~Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria~ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
308536|NCT01225146|O2|Outcome|Treatment Naive (Cohort 2)|"Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.~ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
308537|NCT01225146|O1|Outcome|Treatment Experienced (Cohort 1|"Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).~Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria~ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
308538|NCT01225146|O2|Outcome|Treatment Naive (Cohort 2)|Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.
308539|NCT01225146|O1|Outcome|Treatment Experienced (Cohort 1|"Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).~Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria."
308540|NCT01225146|O2|Outcome|Treatment Naive (Cohort 2)|"Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.~ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
308541|NCT01225146|O1|Outcome|Treatment Experienced (Cohort 1|"Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).~Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria~ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
308542|NCT01225146|E2|Reported Event|Cohort 2|"Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.~ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
308543|NCT01225146|E1|Reported Event|Cohort 1|"Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).~Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria~ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
308544|NCT01225068|B3|Baseline|Total|Total of all reporting groups
308545|NCT01225068|B2|Baseline|Placebo|Placebo treatment group
311517|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
308548|NCT01225068|P1|Participant Flow|Milnacipran|Milnacipran : Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
308549|NCT01225068|O2|Outcome|Milnacipran|Milnacipran : Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
308550|NCT01225068|O1|Outcome|Placebo|Placebo arm
308551|NCT01225068|E2|Reported Event|Placebo|Placebo treatment group
308552|NCT01225068|E1|Reported Event|Milnacipran|Milnacipran : Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
308553|NCT01225055|B4|Baseline|Total|Total of all reporting groups
308554|NCT01225055|B3|Baseline|Teriparatide and Vibration|"Teriparatide with vibration applied in conjuction~Teriparatide: 20 ug daily over 12 months~vibration: 10 min/day for 12 months"
308555|NCT01225055|B2|Baseline|Vibration|"Vibration alone with placebo-teriparatide~vibration: 10 min/day for 12 months"
308556|NCT01225055|B1|Baseline|Teriparatide|"Teriparatide alone with sham vibration~Teriparatide: 20 ug daily over 12 months"
308557|NCT01225055|P3|Participant Flow|Teriparatide and Vibration|"Teriparatide with vibration applied in conjuction~Teriparatide: 20 ug daily over 12 months~vibration: 10 min/day for 12 months"
308558|NCT01225055|P2|Participant Flow|Vibration|"Vibration alone with placebo-teriparatide~vibration: 10 min/day for 12 months"
308559|NCT01225055|P1|Participant Flow|Teriparatide|"Teriparatide alone with sham vibration~Teriparatide: 20 ug daily over 12 months"
308560|NCT01225055|O3|Outcome|Teriparatide and Vibration|"Teriparatide with vibration applied in conjuction~Teriparatide: 20 ug daily over 12 months~vibration: 10 min/day for 12 months"
308561|NCT01225055|O2|Outcome|Vibration|"Vibration alone with placebo-teriparatide~vibration: 10 min/day for 12 months"
308562|NCT01225055|O1|Outcome|Teriparatide|"Teriparatide alone with sham vibration~Teriparatide: 20 ug daily over 12 months"
308563|NCT01225055|O3|Outcome|Teriparatide and Vibration|"Teriparatide with vibration applied in conjuction~Teriparatide: 20 ug daily over 12 months~vibration: 10 min/day for 12 months"
308564|NCT01225055|O2|Outcome|Vibration|"Vibration alone with placebo-teriparatide~vibration: 10 min/day for 12 months"
308565|NCT01225055|O1|Outcome|Teriparatide|"Teriparatide alone with sham vibration~Teriparatide: 20 ug daily over 12 months"
308566|NCT01225055|O3|Outcome|Teriparatide and Vibration|"Teriparatide with vibration applied in conjuction~Teriparatide: 20 ug daily over 12 months~vibration: 10 min/day for 12 months"
308567|NCT01225055|O2|Outcome|Vibration|"Vibration alone with placebo-teriparatide~vibration: 10 min/day for 12 months"
308568|NCT01225055|O1|Outcome|Teriparatide|"Teriparatide alone with sham vibration~Teriparatide: 20 ug daily over 12 months"
308569|NCT01225055|O3|Outcome|Teriparatide and Vibration|"Teriparatide with vibration applied in conjuction~Teriparatide: 20 ug daily over 12 months~vibration: 10 min/day for 12 months"
308570|NCT01225055|O2|Outcome|Vibration|"Vibration alone with placebo-teriparatide~vibration: 10 min/day for 12 months"
308571|NCT01225055|O1|Outcome|Teriparatide|"Teriparatide alone with sham vibration~Teriparatide: 20 ug daily over 12 months"
308572|NCT01225055|O3|Outcome|Teriparatide and Vibration|"Teriparatide with vibration applied in conjuction~Teriparatide: 20 ug daily over 12 months~vibration: 10 min/day for 12 months"
308573|NCT01225055|O2|Outcome|Vibration|"Vibration alone with placebo-teriparatide~vibration: 10 min/day for 12 months"
308574|NCT01225055|O1|Outcome|Teriparatide|"Teriparatide alone with sham vibration~Teriparatide: 20 ug daily over 12 months"
308575|NCT01225055|O3|Outcome|Teriparatide and Vibration|"Teriparatide with vibration applied in conjuction~Teriparatide: 20 ug daily over 12 months~vibration: 10 min/day for 12 months"
308576|NCT01225055|O2|Outcome|Vibration|"Vibration alone with placebo-teriparatide~vibration: 10 min/day for 12 months"
308577|NCT01225055|O1|Outcome|Teriparatide|"Teriparatide alone with sham vibration~Teriparatide: 20 ug daily over 12 months"
308578|NCT01225055|E3|Reported Event|Teriparatide and Vibration|"Teriparatide with vibration applied in conjuction~Teriparatide: 20 ug daily over 12 months~vibration: 10 min/day for 12 months"
308579|NCT01225055|E2|Reported Event|Vibration|"Vibration alone with placebo-teriparatide~vibration: 10 min/day for 12 months"
308580|NCT01225055|E1|Reported Event|Teriparatide|"Teriparatide alone with sham vibration~Teriparatide: 20 ug daily over 12 months"
308581|NCT01225029|B3|Baseline|Total|Total of all reporting groups
308582|NCT01225029|B2|Baseline|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
308583|NCT01225029|B1|Baseline|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
308584|NCT01225029|P2|Participant Flow|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
308585|NCT01225029|P1|Participant Flow|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
308586|NCT01225029|O2|Outcome|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
308587|NCT01225029|O1|Outcome|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
308588|NCT01225029|O2|Outcome|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
308589|NCT01225029|O1|Outcome|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
308590|NCT01225029|O2|Outcome|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
308591|NCT01225029|O1|Outcome|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
308592|NCT01225029|E2|Reported Event|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
308593|NCT01225029|E1|Reported Event|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
308594|NCT01224821|B1|Baseline|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
308595|NCT01224821|P1|Participant Flow|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
308596|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
308597|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
308598|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
308599|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
308618|NCT01224782|O1|Outcome|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
308619|NCT01224782|O1|Outcome|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
308620|NCT01224782|O1|Outcome|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
308600|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
308601|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
308602|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
308603|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
308604|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
308605|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
308606|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
308621|NCT01224782|E1|Reported Event|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
308622|NCT01224639|B9|Baseline|Total|Total of all reporting groups
308623|NCT01224639|B8|Baseline|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
311518|NCT01217112|O5|Outcome|Placebo|Contains excipients only
308607|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
308608|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
308609|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
308610|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
308611|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
308612|NCT01224821|E1|Reported Event|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
308613|NCT01224782|B1|Baseline|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
308614|NCT01224782|P1|Participant Flow|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
308615|NCT01224782|O1|Outcome|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
308616|NCT01224782|O1|Outcome|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
308617|NCT01224782|O1|Outcome|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
308747|NCT01224626|O1|Outcome|Linezolid|Participants who have been treated with Zyvox (linezolid).
308624|NCT01224639|B7|Baseline|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308625|NCT01224639|B6|Baseline|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308626|NCT01224639|B5|Baseline|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308627|NCT01224639|B4|Baseline|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308628|NCT01224639|B3|Baseline|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308629|NCT01224639|B2|Baseline|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308630|NCT01224639|B1|Baseline|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308631|NCT01224639|P8|Participant Flow|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308632|NCT01224639|P7|Participant Flow|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308633|NCT01224639|P6|Participant Flow|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308634|NCT01224639|P5|Participant Flow|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308635|NCT01224639|P4|Participant Flow|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308636|NCT01224639|P3|Participant Flow|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308637|NCT01224639|P2|Participant Flow|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308638|NCT01224639|P1|Participant Flow|Low Dose Subcutaneous: TDV|TDV 0.5 milliliter (mL), injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) (previously DENVax) comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 plaque forming units (PFU), TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308639|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308640|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308641|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308642|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308643|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308644|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308645|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308646|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308647|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308748|NCT01224626|E1|Reported Event|Linezolid|Participants who have been treated with Zyvox (linezolid).
308648|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308649|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308650|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308651|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308652|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308653|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308654|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308655|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308656|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308657|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308658|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308659|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308660|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308661|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308662|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308663|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308664|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308665|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308666|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308667|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308668|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308669|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308670|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308671|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308749|NCT01224444|B1|Baseline|All Adenomatous Polyps|Adenomatous polyps (included serrated adenomas) ≤5mm and ≤20mm.
308750|NCT01224444|P1|Participant Flow|All Adenomatous Polyps|Standard polypectomy snare of adenomatous polyps (included serrated adenomas) from ≥5mm to ≤20mm.
308672|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308673|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308674|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308675|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308676|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308677|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308678|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308679|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308680|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308681|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308682|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308683|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308684|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308685|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308686|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308687|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308688|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308689|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308690|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308691|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308692|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308693|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308694|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308695|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308751|NCT01224444|O1|Outcome|All Adenomatous Polyps|Adenomatous polyps (included serrated adenomas) ≥5mm and ≤20mm.
308752|NCT01224444|E1|Reported Event|All Adenomatous Polyps|Adenomatous polyps (included serrated adenomas) ≤5mm and ≤20mm.
308696|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308697|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308698|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308699|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308700|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308701|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308702|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308703|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308704|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308705|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308706|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308707|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308708|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308709|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308710|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308711|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308712|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308713|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308714|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308715|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308716|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308717|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308718|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308719|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308753|NCT01224431|B3|Baseline|Total|Total of all reporting groups
308754|NCT01224431|B2|Baseline|Normal Saline Via Needleless Injection|needleless injection of normal saline prior to lumbar puncture
311519|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
308720|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308721|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308722|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308723|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308724|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308725|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308726|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308727|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308728|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308729|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308730|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308731|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308732|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308733|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308734|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308735|NCT01224639|E8|Reported Event|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308736|NCT01224639|E7|Reported Event|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308737|NCT01224639|E6|Reported Event|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308738|NCT01224639|E5|Reported Event|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
308739|NCT01224639|E4|Reported Event|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
308740|NCT01224639|E3|Reported Event|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308741|NCT01224639|E2|Reported Event|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
308742|NCT01224639|E1|Reported Event|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
308743|NCT01224626|B1|Baseline|Linezolid|Participants who have been treated with Zyvox (linezolid).
308744|NCT01224626|P1|Participant Flow|Linezolid|Participants who have been treated with Zyvox (linezolid).
308745|NCT01224626|O1|Outcome|Linezolid|Participants who have been treated with Zyvox (linezolid).
308746|NCT01224626|O1|Outcome|Linezolid|Participants who have been treated with Zyvox (linezolid).
308755|NCT01224431|B1|Baseline|Needleless Injection of Buffered Lidocaine|needleless injection of buffered lidocaine prior to lumbar puncture
308756|NCT01224431|P2|Participant Flow|Normal Saline Via Needleless Injection|needleless injection of normal saline prior to lumbar puncture
308757|NCT01224431|P1|Participant Flow|Needleless Injection of Buffered Lidocaine|needleless injection of buffered lidocaine prior to lumbar puncture
308758|NCT01224431|O2|Outcome|Normal Saline Via Needleless Injection|needleless injection of normal saline prior to lumbar puncture
308759|NCT01224431|O1|Outcome|Needleless Injection of Buffered Lidocaine|needleless injection of buffered lidocaine prior to lumbar puncture
308760|NCT01224431|E2|Reported Event|Placebo Comparator: Normal Saline Via Needleless Injection|
308761|NCT01224431|E1|Reported Event|Experimental: Needleless Injection of Buffered Lidocaine|
308762|NCT01224236|B3|Baseline|Total|Total of all reporting groups
308763|NCT01224236|B2|Baseline|Control|multivitamin solution without iron
308764|NCT01224236|B1|Baseline|Iron Supplementation|2 mg/kg/day of elemental iron as a multivitamin with iron solution
308765|NCT01224236|P2|Participant Flow|Control|multivitamin solution without iron
308766|NCT01224236|P1|Participant Flow|Iron Supplementation|2 mg/kg/day of elemental iron as a multivitamin with iron solution
308767|NCT01224236|O2|Outcome|Control|multivitamin solution without iron
308768|NCT01224236|O1|Outcome|Iron Supplementation|2 mg/kg/day of elemental iron as a multivitamin with iron solution
308769|NCT01224236|O2|Outcome|Control|multivitamin solution without iron
308770|NCT01224236|O1|Outcome|Iron Supplementation|2 mg/kg/day of elemental iron as a multivitamin with iron solution
308771|NCT01224236|E2|Reported Event|Control|multivitamin solution without iron
308772|NCT01224236|E1|Reported Event|Iron Supplementation|2 mg/kg/day of elemental iron as a multivitamin with iron solution
308773|NCT01224171|B3|Baseline|Total|Total of all reporting groups
308774|NCT01224171|B2|Baseline|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
308775|NCT01224171|B1|Baseline|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
308776|NCT01224171|P2|Participant Flow|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
308777|NCT01224171|P1|Participant Flow|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
308778|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
308779|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
308780|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
308781|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
308782|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
308783|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
308784|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
308785|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
308786|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
308787|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
308788|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
308789|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
308790|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
308791|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
308792|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
308793|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
308794|NCT01224171|E2|Reported Event|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
308795|NCT01224171|E1|Reported Event|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
308796|NCT01224015|B4|Baseline|Total|Total of all reporting groups
308797|NCT01224015|B3|Baseline|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
308798|NCT01224015|B2|Baseline|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
308799|NCT01224015|B1|Baseline|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
308800|NCT01224015|P3|Participant Flow|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
308801|NCT01224015|P2|Participant Flow|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
308802|NCT01224015|P1|Participant Flow|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
308803|NCT01224015|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
308804|NCT01224015|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
308805|NCT01224015|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
308806|NCT01224015|E3|Reported Event|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
308807|NCT01224015|E2|Reported Event|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
308808|NCT01224015|E1|Reported Event|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
308809|NCT01223963|B1|Baseline|Macrolane|Women that have had breast enhancement with Macrolane Volume Restoration Factor.
308810|NCT01223963|P1|Participant Flow|Macrolane|Women that have had breast enhancement with Macrolane Volume Restoration Factor.
308811|NCT01223963|O1|Outcome|Macrolane|Women that have had breast enhancement with Macrolane Volume Restoration Factor.
308812|NCT01223963|O1|Outcome|Macrolane|Number of related Adverse events reported during the study period
308813|NCT01223963|E1|Reported Event|Macrolane|Women that have had breast enhancement with Macrolane Volume Restoration Factor.
308814|NCT01223937|B3|Baseline|Total|Total of all reporting groups
308815|NCT01223937|B2|Baseline|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
308816|NCT01223937|B1|Baseline|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
308817|NCT01223937|P2|Participant Flow|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
308818|NCT01223937|P1|Participant Flow|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
308819|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
308820|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
308821|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
308822|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
308823|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
308824|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
308825|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
308826|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
308827|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
308828|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
308829|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
308830|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
308831|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
308832|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
308833|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
308834|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
308835|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
308836|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
308837|NCT01223937|E2|Reported Event|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
308838|NCT01223937|E1|Reported Event|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
308839|NCT01223703|B3|Baseline|Total|Total of all reporting groups
308840|NCT01223703|B2|Baseline|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
308841|NCT01223703|B1|Baseline|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
308842|NCT01223703|P2|Participant Flow|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
308843|NCT01223703|P1|Participant Flow|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
308844|NCT01223703|O2|Outcome|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
308845|NCT01223703|O1|Outcome|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
308846|NCT01223703|O2|Outcome|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
308847|NCT01223703|O1|Outcome|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
308848|NCT01223703|O2|Outcome|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
308849|NCT01223703|O1|Outcome|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
308850|NCT01223703|O2|Outcome|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
308851|NCT01223703|O1|Outcome|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
308852|NCT01223703|E2|Reported Event|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
308853|NCT01223703|E1|Reported Event|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
308854|NCT01223469|B3|Baseline|Total|Total of all reporting groups
308855|NCT01223469|B2|Baseline|Right-sided Supraventricular Tachycardia|Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT
308856|NCT01223469|B1|Baseline|Atrial Fibrillation|Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.
308857|NCT01223469|P2|Participant Flow|Right-sided Supraventricular Tachycardia|Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT
308858|NCT01223469|P1|Participant Flow|Atrial Fibrillation|Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.
308859|NCT01223469|O2|Outcome|Right-sided Supraventricular Tachycardia|Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT.
308860|NCT01223469|O1|Outcome|Atrial Fibrillation|Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.
308861|NCT01223469|E2|Reported Event|Right-sided Supraventricular Tachycardia|Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT.
308862|NCT01223469|E1|Reported Event|Atrial Fibrillation|Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.
308863|NCT01223404|B1|Baseline|All Study Participants|Participants in each of the six arms received all three interventions (placebo, nicotine, mecamylamine).
308864|NCT01223404|P6|Participant Flow|Mecamylamine, Nicotine, Placebo|First session: Placebo patch and Mecamylamine capsule Second session: Nicotine patch and Placebo capsule (filler: methylcellulose) Third session: Placebo patch and Placebo capsule (filler: methylcellulose)
308865|NCT01223404|P5|Participant Flow|Mecamylamine, Placebo, Nicotine|First session: Placebo patch and Mecamylamine capsule Second session: Placebo patch and Placebo capsule (filler: methylcellulose) Third session: Nicotine patch and Placebo capsule (filler: methylcellulose)
308866|NCT01223404|P4|Participant Flow|Nicotine, Mecamylamine, Placebo|First session: Nicotine patch and placebo capsule (filler: methylcellulose) Second session: Placebo patch and Mecamylamine capsule Third session: Placebo patch and Placebo capsule (filler: methylcellulose)
308867|NCT01223404|P3|Participant Flow|Placebo, Mecamylamine, Nicotine|First session: Placebo patch and Placebo capsule (filler: methylcellulose) Second session: Placebo patch and Mecamylamine capsule Third session: Nicotine patch and Placebo capsule (filler: methylcellulose)
308868|NCT01223404|P2|Participant Flow|Nicotine, Placebo, Mecamylamine|First session: Nicotine patch and placebo capsule (filler: methylcellulose) Second session: Placebo patch and Placebo capsule (filler: methylcellulose) Third session: Placebo patch and Mecamylamine capsule
308869|NCT01223404|P1|Participant Flow|Placebo, Nicotine, Mecamylamine|First session: Placebo patch and placebo capsule (filler: methylcellulose) Second session: Nicotine patch and Placebo capsule (filler: methylcellulose) Third session: Placebo patch and Mecamylamine capsule
308870|NCT01223404|O3|Outcome|Intervention: Mecamylamine|Placebo patch and mecamylamine capsule.
308871|NCT01223404|O2|Outcome|Intervention: Nicotine|Nicotine patch and placebo capsule.
308872|NCT01223404|O1|Outcome|Intervention: Placebo|Placebo patch and placebo capsule.
308873|NCT01223404|O3|Outcome|Intervention: Mecamylamine|A placebo patch and a mecamylamine capsule were administered.
308874|NCT01223404|O2|Outcome|Intervention: Nicotine|A nicotine patch and a placebo capsule were administered.
308876|NCT01223404|O3|Outcome|Intervention: Mecamylamine|A placebo patch and a mecamylamine capsule were administered.
308877|NCT01223404|O2|Outcome|Intervention: Nicotine|A nicotine patch and a placebo capsule are administered.
308878|NCT01223404|O1|Outcome|Intervention: Placebo|A placebo patch and a placebo capsule are administered.
308879|NCT01223404|O3|Outcome|Intervention: Mecamylamine|A placebo patch and a mecamylamine capsule are administered.
308880|NCT01223404|O2|Outcome|Intervention: Nicotine|A nicotine patch and a placebo capsule are administered.
308881|NCT01223404|O1|Outcome|Intervention: Placebo|A placebo patch and a placebo capsule is administered.
308882|NCT01223404|O3|Outcome|Intervention: Mecamylamine|A placebo patch and a mecamylamine capsule are administered.
308883|NCT01223404|O2|Outcome|Intervention: Nicotine|A nicotine patch and a placebo capsule are administered.
308884|NCT01223404|O1|Outcome|Intervention: Placebo|A placebo patch and a placebo capsule are administered.
308885|NCT01223404|O3|Outcome|Intervention: Mecamylamine|A placebo patch and a mecamylamine capsule are administered.
308886|NCT01223404|O2|Outcome|Intervention: Nicotine|A nicotine patch and a placebo capsule is administered.
308887|NCT01223404|O1|Outcome|Intervention: Placebo|A placebo patch and a placebo capsule are administered.
308888|NCT01223404|E3|Reported Event|Intervention: Mecamylamine|Participants receive a placebo patch and a mecamylamine capsule.
308889|NCT01223404|E2|Reported Event|Intervention: Nicotine|Participants receive a nicotine patch and a placebo capsule.
308890|NCT01223404|E1|Reported Event|Intervention: Placebo|Participants receive a placebo patch and a placebo capsule.
308891|NCT01223365|B1|Baseline|Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at th3 successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
308892|NCT01223365|P1|Participant Flow|Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at the successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
308893|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
308894|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
308895|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
308896|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
308897|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
308898|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
308899|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
308900|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
308901|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
308902|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
308903|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
308904|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
308905|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
308906|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
308907|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
308908|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
308909|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
308910|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
308911|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
308912|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
308913|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
308914|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
308915|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
308916|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
308917|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
308918|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
308919|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
308920|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
308921|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
308922|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
308923|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
308924|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
308925|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
308926|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
308927|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
308928|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
308929|NCT01223365|E3|Reported Event|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
308930|NCT01223365|E2|Reported Event|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
308931|NCT01223365|E1|Reported Event|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
308932|NCT01223352|B3|Baseline|Total|Total of all reporting groups
308933|NCT01223352|B2|Baseline|Bosentan 2 mg/kg b.i.d.|2 mg/kg bosentan (dispersible tablets) was administered orally twice daily (b.i.d.) for a planned duration of 24 weeks
308934|NCT01223352|B1|Baseline|Bosentan 2 mg/kg t.i.d.|2 mg/kg bosentan (dispersible tablets) was administered orally three times a day (t.i.d.) for a planned duration of 24 weeks
308935|NCT01223352|P2|Participant Flow|Bosentan 2 mg/kg b.i.d.|2 mg/kg bosentan (dispersible tablets) was administered orally twice daily (b.i.d.) for a planned duration of 24 weeks
308936|NCT01223352|P1|Participant Flow|Bosentan 2 mg/kg t.i.d.|2 mg/kg bosentan (dispersible tablets) was administered orally three times a day (t.i.d.) for a planned duration of 24 weeks
308937|NCT01223352|O2|Outcome|Bosentan 2 mg/kg b.i.d. (ITT Set)|Patients randomized to the bosentan 2 mg/kg b.i.d. group who received at least one oral dose of bosentan.
308938|NCT01223352|O1|Outcome|Bosentan 2 mg/kg t.i.d. (ITT Set)|Patients randomized to the bosentan 2 mg/kg t.i.d. group who received at least one oral dose of bosentan.
308939|NCT01223352|O2|Outcome|Bosentan 2 mg/kg b.i.d. (ITT Set)|Patients randomized to the bosentan 2 mg/kg b.i.d. group who received at least one oral dose of bosentan.
308940|NCT01223352|O1|Outcome|Bosentan 2 mg/kg t.i.d. (ITT Set)|Patients randomized to the bosentan 2 mg/kg t.i.d. group who received at least one oral dose of bosentan.
308941|NCT01223352|O2|Outcome|Bosentan 2 mg/kg b.i.d.|Patients randomized to the bosentan 2 mg/kg b.i.d. group
308942|NCT01223352|O1|Outcome|Bosentan 2 mg/kg t.i.d.|Patients randomized to the bosentan 2 mg/kg t.i.d. group
308943|NCT01223352|O2|Outcome|Bosentan 2 mg/kg b.i.d|Patients randomized to the bosentan 2 mg/kg b.i.d. group.
308944|NCT01223352|O1|Outcome|Bosentan 2 mg/kg t.i.d.|Patients randomized to the bosentan 2 mg/kg t.i.d. group.
308945|NCT01223352|O2|Outcome|Bosentan 2 mg/kg b.i.d. (PK Set)|Patients randomized to the bosentan 2 mg/kg b.i.d. group who received at least one oral dose of bosentan and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.
308946|NCT01223352|O1|Outcome|Bosentan 2 mg/kg t.i.d. (PK Set)|Patients randomized to the bosentan 2 mg/kg t.i.d. group who received at least one oral dose of bosentan and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.
308947|NCT01223352|O2|Outcome|Bosentan 2 mg/kg b.i.d. (PK Set)|Patients randomized to the bosentan 2 mg/kg b.i.d. group who received at least one oral dose of bosentan and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.
308948|NCT01223352|O1|Outcome|Bosentan 2 mg/kg t.i.d. (PK Set)|Patients randomized to the bosentan 2 mg/kg t.i.d. group who received at least one oral dose of bosentan and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.
308949|NCT01223352|O2|Outcome|Bosentan 2 mg/kg b.i.d. (PK Set)|Patients randomized to the bosentan 2 mg/kg b.i.d. group who received at least one oral dose of bosentan and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.
308950|NCT01223352|O1|Outcome|Bosentan 2 mg/kg t.i.d. (PK Set)|Patients randomized to the bosentan 2 mg/kg t.i.d. group who received at least one oral dose of bosentan and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.
308951|NCT01223352|O2|Outcome|Bosentan 2 mg/kg b.i.d. (PK Set)|Patients randomized to the bosentan 2 mg/kg b.i.d. group who received at least one oral dose of bosentan and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.
308952|NCT01223352|O1|Outcome|Bosentan 2 mg/kg t.i.d. (PK Set)|Patients randomized to the bosentan 2 mg/kg t.i.d. group who received at least one oral dose of bosentan and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.
308953|NCT01223352|E2|Reported Event|Bosentan 2 mg/kg b.i.d|Patients received 2 mg/kg of bosentan twice daily (morning and evening) for at least 6 weeks and up to 26.4 weeks
308954|NCT01223352|E1|Reported Event|Bosentan 2 mg/kg t.i.d|Patients received 2 mg/kg of bosentan 3 times a day (morning, afternoon, evening) for at least 0.4 week and up to 28.7 weeks
308955|NCT01223235|B1|Baseline|Bevacizumab & Polyvalent Vaccine-KLH Conjugate + OPT-821|This is a single institution, open label, pilot study of bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821 in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
308956|NCT01223235|P1|Participant Flow|Bevacizumab & Polyvalent Vaccine-KLH Conjugate + OPT-821|This is a single institution, open label, pilot study of bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821 in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
308957|NCT01223235|O1|Outcome|Bevacizumab & Polyvalent Vaccine-KLH Conjugate + OPT-821|This is a single institution, open label, pilot study of bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821 in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
308958|NCT01223235|O1|Outcome|Bevacizumab & Polyvalent Vaccine-KLH Conjugate + OPT-821|This is a single institution, open label, pilot study of bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821 in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
308959|NCT01223235|O1|Outcome|Bevacizumab & Polyvalent Vaccine-KLH Conjugate + OPT-821|This is a single institution, open label, pilot study of bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821 in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
308960|NCT01223235|E1|Reported Event|Bevacizumab & Polyvalent Vaccine-KLH Conjugate + OPT-821|This is a single institution, open label, pilot study of bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821 in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
308961|NCT01223196|B3|Baseline|Total|Total of all reporting groups
308962|NCT01223196|B2|Baseline|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone
308963|NCT01223196|B1|Baseline|Placebo|One arm of the study subjects will be treated with Placebo only.
308964|NCT01223196|P2|Participant Flow|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone, 15mg, 1 capsule/day.
308965|NCT01223196|P1|Participant Flow|Placebo|One arm of the study subjects will be treated with Placebo only, once a day.
308966|NCT01223196|O2|Outcome|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone, 15mg, 1 capsule/day.
308967|NCT01223196|O1|Outcome|Placebo|One arm of the study subjects will be treated with Placebo only, once a day.
308968|NCT01223196|O2|Outcome|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone
308969|NCT01223196|O1|Outcome|Placebo|One arm of the study subjects will be treated with Placebo only.
308970|NCT01223196|O2|Outcome|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone
308971|NCT01223196|O1|Outcome|Placebo|One arm of the study subjects will be treated with Placebo only.
308972|NCT01223196|E2|Reported Event|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone
308973|NCT01223196|E1|Reported Event|Placebo|One arm of the study subjects will be treated with Placebo only.
308974|NCT01223183|B3|Baseline|Total|Total of all reporting groups
308975|NCT01223183|B2|Baseline|Hypertonic Saline Then Isotonic Saline|Subjects inhaled 7% hypertonic saline on study day 1, then had a washout period of 5-24 days, then inhaled isotonic saline on study day 2
308976|NCT01223183|B1|Baseline|Isotonic Saline Then Hypertonic Saline|Subjects inhaled isotonic saline on study day 1, then had a washout period of 5-24 days, then inhaled 7% hypertonic saline on study day 2
308977|NCT01223183|P2|Participant Flow|Hypertonic Saline Then Isotonic Saline|Subjects inhale nebulized 7% hypertonic saline on study day 1, then perform a 5-24 day washout period, and then inhale nebulized isotonic saline on study day 2.
308978|NCT01223183|P1|Participant Flow|Isotonic Saline Then Hypertonic Saline|Subjects inhale nebulized isotonic saline on study day 1, then perform a washout period of 5-24 days, then inhale 7% hypertonic saline on study day 2.
308979|NCT01223183|O1|Outcome|Hypertonic Saline Inhalation|Results from hypertonic saline inhalation day
308980|NCT01223183|O1|Outcome|Isotonic Saline Inhalation|Results from isotonic saline inhalation day
308981|NCT01223183|O1|Outcome|Hypertonic Saline Inhalation|Results from hypertonic saline inhalation day
308982|NCT01223183|O1|Outcome|Isotonic Saline Inhalation|Results from isotonic inhalation day
308983|NCT01223183|E2|Reported Event|Hypertonic Saline Then Isotonic Saline|Subjects inhaled hypertonic saline on study day 1 and isotonic saline on study day 2
308984|NCT01223183|E1|Reported Event|Isotonic Saline Then Hypertonic Saline|Subjects inhaled isotonic saline on study day 1 and hypertonic saline on study day 2
308985|NCT01223027|B3|Baseline|Total|Total of all reporting groups
308986|NCT01223027|B2|Baseline|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
308987|NCT01223027|B1|Baseline|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
308988|NCT01223027|P2|Participant Flow|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
308989|NCT01223027|P1|Participant Flow|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
308990|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
308991|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
308992|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
308993|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
308994|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
308995|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
308996|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
308997|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
308998|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
308999|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
309000|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
309001|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
309002|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
309003|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
309004|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
309005|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
309006|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
309007|NCT01223027|E2|Reported Event|Sorafenib|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
309008|NCT01223027|E1|Reported Event|Dovitinib|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
309009|NCT01223001|B3|Baseline|Total|Total of all reporting groups
309010|NCT01223001|B2|Baseline|Sugar Pill|Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
309011|NCT01223001|B1|Baseline|Duloxetine|Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
309012|NCT01223001|P2|Participant Flow|Sugar Pill|Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
309013|NCT01223001|P1|Participant Flow|Duloxetine|Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
309014|NCT01223001|O2|Outcome|Sugar Pill|Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
309015|NCT01223001|O1|Outcome|Duloxetine|Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
309016|NCT01223001|E2|Reported Event|Sugar Pill|Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
309017|NCT01223001|E1|Reported Event|Duloxetine|Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
309018|NCT01222884|B3|Baseline|Total|Total of all reporting groups
309019|NCT01222884|B2|Baseline|Iron Sucrose|"Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics"
309020|NCT01222884|B1|Baseline|Iron Isomaltoside 1000|"Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes"
309021|NCT01222884|P2|Participant Flow|Iron Sucrose|"Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics"
309022|NCT01222884|P1|Participant Flow|Iron Isomaltoside 1000|"Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes"
309023|NCT01222884|O2|Outcome|Iron Sucrose|"Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics"
309024|NCT01222884|O1|Outcome|Iron Isomaltoside 1000|"Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes"
309025|NCT01222884|O2|Outcome|Iron Sucrose|"Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics"
309026|NCT01222884|O1|Outcome|Iron Isomaltoside 1000|"Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes"
309027|NCT01222884|E2|Reported Event|Iron Sucrose|"Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics"
309117|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
311520|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
309028|NCT01222884|E1|Reported Event|Iron Isomaltoside 1000|"Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes"
309029|NCT01222832|B3|Baseline|Total|Total of all reporting groups
309030|NCT01222832|B2|Baseline|Saline|Nasopore sponge soaked in saline
309031|NCT01222832|B1|Baseline|Bacitracin|"Nasopore sponge soaked in Bacitracin~Bacitracin: Bacitracin soaked sponge"
309032|NCT01222832|P2|Participant Flow|Saline|Saline soaked sponge and oral antibiotics
309033|NCT01222832|P1|Participant Flow|Bacitracin|"Nasopore sponge soaked in Bacitracin~Bacitracin: Bacitracin soaked sponge"
309034|NCT01222832|O2|Outcome|Saline|Saline soaked sponge and oral antibiotics
309035|NCT01222832|O1|Outcome|Bacitracin|Bacitracin soaked sponge
309036|NCT01222832|E2|Reported Event|Saline|Saline soaked sponge and oral antibiotics
309037|NCT01222832|E1|Reported Event|Bacitracin|Bacitracin soaked sponge
309038|NCT01222715|B3|Baseline|Total|Total of all reporting groups
309039|NCT01222715|B2|Baseline|Regimen B|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
309040|NCT01222715|B1|Baseline|Regimen A|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
309041|NCT01222715|P2|Participant Flow|Regimen B|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
309042|NCT01222715|P1|Participant Flow|Regimen A|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
309043|NCT01222715|O2|Outcome|Regimen B|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
309044|NCT01222715|O1|Outcome|Regimen A|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
309045|NCT01222715|O2|Outcome|Regimen B|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
309046|NCT01222715|O1|Outcome|Regimen A|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
309047|NCT01222715|O2|Outcome|Regimen B|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
309048|NCT01222715|O1|Outcome|Regimen A|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
309049|NCT01222715|E2|Reported Event|Regimen B|Vinorelbine/cyclophosphamide (VC) + temsirolimus
309050|NCT01222715|E1|Reported Event|Regimen A|Vinorelbine/cyclophosphamide (VC) + bevacizumab
309051|NCT01222689|B1|Baseline|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib by mouth (PO) every day (QD) and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
309052|NCT01222689|P1|Participant Flow|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
309053|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
309054|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
309055|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
309056|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
309057|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
309118|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309119|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309058|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
309059|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
309060|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
309061|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
309062|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
309063|NCT01222689|E1|Reported Event|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
309064|NCT01222585|B1|Baseline|Treatment|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
309065|NCT01222585|P1|Participant Flow|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
309066|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
309067|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
309068|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
309069|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
309070|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
309071|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
309072|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
309073|NCT01222585|E1|Reported Event|Treatment|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
309074|NCT01222572|B1|Baseline|Stereotactic Boost to Chemoradiotherapy (Dose Level 1)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 54 Gy; Stereotactic Boost to Primary: 10 Gy; Total Dose to Primary: 64 Gy~Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
309075|NCT01222572|P3|Participant Flow|Stereotactic Boost to Chemoradiotherapy (Dose Level 3)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 46 Gy; Stereotactic Boost to Primary: 20 Gy; Total Dose to Primary: 66 Gy~Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
309076|NCT01222572|P2|Participant Flow|Stereotactic Boost to Chemoradiotherapy (Dose Level 2)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 50 Gy; Stereotactic Boost to Primary: 15 Gy; Total Dose to Primary: 65 Gy~Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
309077|NCT01222572|P1|Participant Flow|Stereotactic Boost to Chemoradiotherapy (Dose Level 1)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 54 Gy; Stereotactic Boost to Primary: 10 Gy; Total Dose to Primary: 64 Gy~Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
309078|NCT01222572|O1|Outcome|Stereotactic Boost to Chemoradiotherapy (Dose Level 1)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 54 Gy; Stereotactic Boost to Primary: 10 Gy; Total Dose to Primary: 64 Gy~Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
309079|NCT01222572|E1|Reported Event|Stereotactic Boost to Chemoradiotherapy (Dose Level 1)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 54 Gy; Stereotactic Boost to Primary: 10 Gy; Total Dose to Primary: 64 Gy~Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
309080|NCT01222533|B1|Baseline|Study Overall|Total number of patients randomised and treated in the study.
309081|NCT01222533|P1|Participant Flow|Study Overall|Total number of patients randomised and treated in the study. This was a randomised 5-period crossover trial. 154 patients were randomised to one of 15 sequences and treated. The trial was blinded within the 4 Respimat treatments, but open for the HandiHaler treatment. Each of the 5 treatment regimens was taken for 4 weeks without washouts between treatment periods.
309082|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
309083|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309084|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309085|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309086|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309087|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
309088|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309089|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309090|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309091|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309092|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
309093|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309094|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309095|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309096|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309097|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
309098|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309099|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309100|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309101|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309102|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
309103|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309104|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309105|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309106|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309107|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
309108|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309109|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309110|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309111|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309112|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
309113|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309114|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309115|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309116|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309231|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
309120|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309121|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309122|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
309123|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309124|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309125|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309126|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309127|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
309128|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309129|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309130|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309131|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309132|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
309133|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309134|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309135|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309136|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309137|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
309138|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309139|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309140|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309141|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309142|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
309143|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309144|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309145|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309146|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309147|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
309148|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309149|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309150|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309151|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309152|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
309153|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309154|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309155|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309156|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309157|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
309158|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309159|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309160|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309161|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309162|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
309163|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309164|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309165|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309166|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309167|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
309168|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309169|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309170|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309171|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309232|NCT01222520|O2|Outcome|Telmisartan|
309172|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
309173|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309174|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309175|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309176|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309177|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
309178|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309179|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309180|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309181|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309182|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
309183|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309184|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309185|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309186|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309187|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
309188|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309189|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309190|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309191|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309192|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
309193|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309194|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309195|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309196|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309197|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
309198|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309199|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309200|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309201|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309202|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
309203|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309204|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309205|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309206|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309207|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
309208|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309209|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309210|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309211|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309212|NCT01222533|E5|Reported Event|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
309213|NCT01222533|E4|Reported Event|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
309214|NCT01222533|E3|Reported Event|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
309215|NCT01222533|E2|Reported Event|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
309216|NCT01222533|E1|Reported Event|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
309217|NCT01222520|B3|Baseline|Total|Total of all reporting groups
309218|NCT01222520|B2|Baseline|Telmisartan|
309219|NCT01222520|B1|Baseline|Telmisartan and Amlodipine FDC|
309220|NCT01222520|P2|Participant Flow|Telmisartan|
309221|NCT01222520|P1|Participant Flow|Telmisartan and Amlodipine FDC|
309222|NCT01222520|O2|Outcome|Telmisartan|
309223|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
309224|NCT01222520|O2|Outcome|Telmisartan|
309225|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
309226|NCT01222520|O2|Outcome|Telmisartan|
309227|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
309228|NCT01222520|O2|Outcome|Telmisartan|
309229|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
309230|NCT01222520|O2|Outcome|Telmisartan|
309238|NCT01222507|B1|Baseline|Brain Speed Test|60 subjects who complete 60 Second Brain Game and Brain Speed Test
309239|NCT01222507|P1|Participant Flow|Brain Speed Test (BST)|60 subjects who complete 60 Second Brain Game and Brain Speed Test
309240|NCT01222507|O1|Outcome|Brain Processing Speed|Brain Speed Test is measured through Brain Speed Test, and the results are transformed to z-scores based on normal population data.Z-score is calculated by subtracting the raw score (x) from the mean of the population (µ) which is then divided by the standard deviation of the population.
309241|NCT01222507|E1|Reported Event|Brain Speed Test|60 subjects who complete 60 Second Brain Game and Brain Speed Test
309242|NCT01222416|B3|Baseline|Total|Total of all reporting groups
309243|NCT01222416|B2|Baseline|Fluorodeoxythymidine PET/CT (FLT-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.~Radiopharmaceutical: [18F]-FLT: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection."
309244|NCT01222416|B1|Baseline|Fluorodeoxyglucose PET/CT (FDG-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.~Radiopharmaceutical Administration [18F]-FDG: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection."
309245|NCT01222416|P2|Participant Flow|Fluorodeoxythymidine PET/CT (FLT-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.~Radiopharmaceutical: [18F]-FLT: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection."
309246|NCT01222416|P1|Participant Flow|Fluorodeoxyglucose PET/CT (FDG-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.~Radiopharmaceutical Administration [18F]-FDG: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection."
309247|NCT01222416|O2|Outcome|Fluorodeoxythymidine PET/CT (FLT-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.~Radiopharmaceutical: [18F]-FLT: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection."
309248|NCT01222416|O1|Outcome|Fluorodeoxyglucose PET/CT (FDG-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.~Radiopharmaceutical Administration [18F]-FDG: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection."
309249|NCT01222416|O2|Outcome|Fluorodeoxythymidine PET/CT (FLT-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.~Radiopharmaceutical: [18F]-FLT: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection."
309250|NCT01222416|O1|Outcome|Fluorodeoxyglucose PET/CT (FDG-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.~Radiopharmaceutical Administration [18F]-FDG: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection."
309251|NCT01222416|E2|Reported Event|Fluorodeoxythymidine PET/CT (FLT-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.~Radiopharmaceutical: [18F]-FLT: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection."
309252|NCT01222416|E1|Reported Event|Fluorodeoxyglucose PET/CT (FDG-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.~Radiopharmaceutical Administration [18F]-FDG: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection."
309253|NCT01222403|B3|Baseline|Total|Total of all reporting groups
309254|NCT01222403|B2|Baseline|Vantaflu_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
309255|NCT01222403|B1|Baseline|Fluad_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
309256|NCT01222403|P2|Participant Flow|Vantaflu_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
309257|NCT01222403|P1|Participant Flow|Fluad_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
309258|NCT01222403|O2|Outcome|Vantaflu_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
309259|NCT01222403|O1|Outcome|Fluad_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
309260|NCT01222403|O2|Outcome|Vantaflu_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
309261|NCT01222403|O1|Outcome|Fluad_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
309262|NCT01222403|O2|Outcome|Vantaflu_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
309263|NCT01222403|O1|Outcome|Fluad_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
309264|NCT01222403|E2|Reported Event|Vantaflu_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
309265|NCT01222403|E1|Reported Event|Fluad_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
309443|NCT01221727|O1|Outcome|Midazolam Only|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16
309266|NCT01222390|B1|Baseline|Contour Profile Tissue Exander|"Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).~Contour Profile Tissue Expander: The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement."
309267|NCT01222390|P1|Participant Flow|Contour Profile Tissue Exander|"Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).~Contour Profile Tissue Expander: The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement."
309268|NCT01222390|O1|Outcome|Contour Profile Tissue Exander|"Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).~Contour Profile Tissue Expander: The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement."
309269|NCT01222390|E1|Reported Event|Contour Profile Tissue Exander|"Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).~Contour Profile Tissue Expander: The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement."
309270|NCT01222286|B3|Baseline|Total|Total of all reporting groups
309271|NCT01222286|B2|Baseline|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
309272|NCT01222286|B1|Baseline|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
309273|NCT01222286|P2|Participant Flow|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
309274|NCT01222286|P1|Participant Flow|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
309275|NCT01222286|O2|Outcome|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
309276|NCT01222286|O1|Outcome|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
309277|NCT01222286|O2|Outcome|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
309278|NCT01222286|O1|Outcome|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
309279|NCT01222286|O2|Outcome|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
309280|NCT01222286|O1|Outcome|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
309281|NCT01222286|O2|Outcome|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
309282|NCT01222286|O1|Outcome|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
309283|NCT01222286|E2|Reported Event|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
309284|NCT01222286|E1|Reported Event|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
309285|NCT01222273|B1|Baseline|Cholecalciferol|"2000 Units of cholecalciferol once daily~cholecalciferol (Vitamin D3): 4,000 IU of cholecalciferol (Vitamin D3) orally every day for six months"
309286|NCT01222273|P1|Participant Flow|Cholecalciferol|"2000 Units of cholecalciferol once daily~cholecalciferol (Vitamin D3): 4,000 IU of cholecalciferol (Vitamin D3) orally every day for six months"
309287|NCT01222273|O1|Outcome|Cholecalciferol|"2000 Units of cholecalciferol once daily~cholecalciferol (Vitamin D3): 4,000 IU of cholecalciferol (Vitamin D3) orally every day for six months"
309288|NCT01222273|O1|Outcome|Cholecalciferol|"2000 Units of cholecalciferol once daily~cholecalciferol (Vitamin D3): 4,000 IU of cholecalciferol (Vitamin D3) orally every day for six months"
309289|NCT01222273|O1|Outcome|Cholecalciferol|"2000 Units of cholecalciferol once daily~cholecalciferol (Vitamin D3): 4,000 IU of cholecalciferol (Vitamin D3) orally every day for six months"
309290|NCT01222273|E1|Reported Event|Cholecalciferol|"2000 Units of cholecalciferol once daily~cholecalciferol (Vitamin D3): 4,000 IU of cholecalciferol (Vitamin D3) orally every day for six months"
309291|NCT01222234|B4|Baseline|Total|Total of all reporting groups
309292|NCT01222234|B3|Baseline|Group 3: Cholecalciferol|"Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
309293|NCT01222234|B2|Baseline|Group 2: Calcitriol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~calcitriol: calcitriol 0.25 mcg every day"
309294|NCT01222234|B1|Baseline|Group 1: Cholecalciferol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
309295|NCT01222234|P3|Participant Flow|Group 3: Cholecalciferol|"Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
309296|NCT01222234|P2|Participant Flow|Group 2: Calcitriol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~calcitriol: calcitriol 0.25 mcg every day"
309297|NCT01222234|P1|Participant Flow|Group 1: Cholecalciferol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
309298|NCT01222234|O2|Outcome|Group 3: Non-CKD Cholecalciferol|"Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
311521|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
309299|NCT01222234|O1|Outcome|Group 1: CKD Cholecalciferol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
309300|NCT01222234|O2|Outcome|Group 2: Calcitriol - CKD|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~Calcitriol 0.25 mcg every day"
309301|NCT01222234|O1|Outcome|Group 1: Cholecalciferol - CKD|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~Cholecalciferol 50,000 IU twice weekly for 8 weeks"
309302|NCT01222234|E3|Reported Event|Group 3: Cholecalciferol|"Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
309303|NCT01222234|E2|Reported Event|Group 2: Calcitriol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~calcitriol: calcitriol 0.25 mcg every day"
309304|NCT01222234|E1|Reported Event|Group 1: Cholecalciferol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
309305|NCT01222195|B1|Baseline|Lenalidomide + Darbepoetin Alfa|Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
309306|NCT01222195|P1|Participant Flow|Lenalidomide + Darbepoetin Alfa|Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
309307|NCT01222195|O1|Outcome|Lenalidomide + Darbepoetin Alfa|Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
309308|NCT01222195|E1|Reported Event|Lenalidomide + Darbepoetin Alfa|Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
309309|NCT01222117|B12|Baseline|Total|Total of all reporting groups
309310|NCT01222117|B11|Baseline|Plasmin Open-label Treatment Group M|"Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
309311|NCT01222117|B10|Baseline|Plasmin Open-label Treatment Group J|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
309312|NCT01222117|B9|Baseline|Plasmin Open-label Treatment Group I|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
309313|NCT01222117|B8|Baseline|Plasmin Open-label Treatment Group H|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
309314|NCT01222117|B7|Baseline|Plasmin Open-label Treatment Group G|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
309315|NCT01222117|B6|Baseline|PA Placebo Blinded Treatment Arm F|"PA placebo (normal saline for injection) administered for 5 hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration~Placebo: Normal saline for injection at the same volume as the plasminogen activator."
309316|NCT01222117|B5|Baseline|Plasminogen Activator Blinded Group E|"PA administered for 5 hours at a dose and volume according to the Investigator's clinical judgement/standard practice~Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment."
309317|NCT01222117|B4|Baseline|Plasmin Open-label Treatment Group D|"Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
309318|NCT01222117|B3|Baseline|Plasmin Open-label Treatment Group C|"Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
309319|NCT01222117|B2|Baseline|Plasmin Open-label Treatment Group B|"Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
309320|NCT01222117|B1|Baseline|Plasmin Open-label Treatment Group A|"Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
309321|NCT01222117|P11|Participant Flow|Plasmin Open-label Treatment Group M|"Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
309322|NCT01222117|P10|Participant Flow|Plasmin Open-label Treatment Group J|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
309323|NCT01222117|P9|Participant Flow|Plasmin Open-label Treatment Group I|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
309324|NCT01222117|P8|Participant Flow|Plasmin Open-label Treatment Group H|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
309325|NCT01222117|P7|Participant Flow|Plasmin Open-label Treatment Group G|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
309326|NCT01222117|P6|Participant Flow|PA Placebo Blinded Treatment Arm F|"PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration~Placebo: Normal saline for injection at the same volume as the plasminogen activator."
309327|NCT01222117|P5|Participant Flow|Plasminogen Activator Blinded Group E|"PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice~Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment."
309328|NCT01222117|P4|Participant Flow|Plasmin Open-label Treatment Group D|"Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
309329|NCT01222117|P3|Participant Flow|Plasmin Open-label Treatment Group C|"Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
309330|NCT01222117|P2|Participant Flow|Plasmin Open-label Treatment Group B|"Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
309331|NCT01222117|P1|Participant Flow|Plasmin Open-label Treatment Group A|"Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
309332|NCT01222117|O11|Outcome|Plasmin Open-label Treatment Group M|"Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
309333|NCT01222117|O10|Outcome|Plasmin Open-label Treatment Group J|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
309334|NCT01222117|O9|Outcome|Plasmin Open-label Treatment Group I|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
309335|NCT01222117|O8|Outcome|Plasmin Open-label Treatment Group H|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
309336|NCT01222117|O7|Outcome|Plasmin Open-label Treatment Group G|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
309337|NCT01222117|O6|Outcome|PA Placebo Blinded Treatment Arm F|"PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration~Placebo: Normal saline for injection at the same volume as the plasminogen activator."
309338|NCT01222117|O5|Outcome|Plasminogen Activator Blinded Group E|"PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice~Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment."
309339|NCT01222117|O4|Outcome|Plasmin Open-label Treatment Group D|"Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
309340|NCT01222117|O3|Outcome|Plasmin Open-label Treatment Group C|"Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
309341|NCT01222117|O2|Outcome|Plasmin Open-label Treatment Group B|"Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
309342|NCT01222117|O1|Outcome|Plasmin Open-label Treatment Group A|"Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
309343|NCT01222117|O11|Outcome|Plasmin Open-label Treatment Group M|"Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
309344|NCT01222117|O10|Outcome|Plasmin Open-label Treatment Group J|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
309345|NCT01222117|O9|Outcome|Plasmin Open-label Treatment Group I|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
309346|NCT01222117|O8|Outcome|Plasmin Open-label Treatment Group H|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
309347|NCT01222117|O7|Outcome|Plasmin Open-label Treatment Group G|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
309348|NCT01222117|O6|Outcome|PA Placebo Blinded Treatment Arm F|"PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration~Placebo: Normal saline for injection at the same volume as the plasminogen activator."
309349|NCT01222117|O5|Outcome|Plasminogen Activator Blinded Group E|"PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice~Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment."
309350|NCT01222117|O4|Outcome|Plasmin Open-label Treatment Group D|"Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
309351|NCT01222117|O3|Outcome|Plasmin Open-label Treatment Group C|"Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
309352|NCT01222117|O2|Outcome|Plasmin Open-label Treatment Group B|"Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
309353|NCT01222117|O1|Outcome|Plasmin Open-label Treatment Group A|"Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
309354|NCT01222117|E11|Reported Event|Plasmin Open-label Treatment Group M|"Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
309355|NCT01222117|E10|Reported Event|Plasmin Open-label Treatment Group J|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
309356|NCT01222117|E9|Reported Event|Plasmin Open-label Treatment Group I|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
309357|NCT01222117|E8|Reported Event|Plasmin Open-label Treatment Group H|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
309358|NCT01222117|E7|Reported Event|Plasmin Open-label Treatment Group G|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
309359|NCT01222117|E6|Reported Event|PA Placebo Blinded Treatment Arm F|"PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration~Placebo: Normal saline for injection at the same volume as the plasminogen activator."
309360|NCT01222117|E5|Reported Event|Plasminogen Activator Blinded Group E|"PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice~Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment."
309361|NCT01222117|E4|Reported Event|Plasmin Open-label Treatment Group D|"Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
309362|NCT01222117|E3|Reported Event|Plasmin Open-label Treatment Group C|"Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
309363|NCT01222117|E2|Reported Event|Plasmin Open-label Treatment Group B|"Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
309364|NCT01222117|E1|Reported Event|Plasmin Open-label Treatment Group A|"Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
309365|NCT01222104|B1|Baseline|All Participants|
309366|NCT01222104|P1|Participant Flow|All Participants|
309367|NCT01222104|O1|Outcome|Participants With Deployment|Participants with successful or attempted Angio-Seal deployments
309368|NCT01222104|O1|Outcome|Participants With Deployments|Participants with successful or attempted Angio-Seal deployments
309369|NCT01222104|O1|Outcome|Participants With Deployments|Participants with successful or attempted Angio-Seal deployments
309370|NCT01222104|O1|Outcome|All Participants|
309371|NCT01222104|O1|Outcome|Participants With Deployments|Participants with successful or attempted Angio-Seal deployments
309372|NCT01222104|O1|Outcome|Participants With Deployments|Participants with successful or attempted Angio-Seal deployments
309373|NCT01222104|O1|Outcome|All Participants With Deployments and Readable Angiograms|
309374|NCT01222104|O1|Outcome|All Participants|All enrolled participants
309375|NCT01222104|O1|Outcome|All Participants|
309376|NCT01222104|O1|Outcome|Angio-Seal|Secondary outcome reported in subjects with successful Angio-Seal deployment which achieved hemostasis by device.
309377|NCT01222104|O1|Outcome|Angio -Seal|Angio-Seal attempted and/or deployed group
309378|NCT01222104|E1|Reported Event|All Participants|
309379|NCT01222078|B1|Baseline|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309380|NCT01222078|P1|Participant Flow|Otelixizumab|Participant received a single dose of otelixizumab intravenous (IV) infusions each given over a 30 minute period on 8 consecutive days in order: 0.1 milligrams (mg), 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before start of infusion (SOI), 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309381|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309382|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309383|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309384|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309437|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16, and 60 mg subcutaneous dose of Denosumab on day 2
309438|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16, and 60 mg subcutaneous dose of Denosumab on day 2
309385|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309386|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309387|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309388|NCT01222078|O1|Outcome|Overall Study Arm|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309389|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309390|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309391|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309392|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309393|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309394|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309395|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309396|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309397|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309439|NCT01221727|O1|Outcome|Midazolam Only|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16
309440|NCT01221727|O1|Outcome|Midazolam Only|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16
311522|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
309398|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309399|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309400|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309401|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309402|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309403|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309404|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309405|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309406|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309407|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309408|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309409|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309410|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309441|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16, and 60 mg subcutaneous dose of Denosumab on day 2
309442|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16 , and 60 mg subcutaneous dose of Denosumab on day 2
309411|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309412|NCT01222078|E1|Reported Event|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
309413|NCT01221948|B1|Baseline|Deep Brain Stimulation|"Vercise (TM) Rechargeable Deep Brain Stimulation System~Deep Brain Stimulation: Rechargeable Deep Brain Stimulation System"
309414|NCT01221948|P1|Participant Flow|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
309415|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
309416|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
309417|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
309418|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
309419|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
309420|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
309421|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
309422|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
309423|NCT01221948|E1|Reported Event|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
309424|NCT01221753|B1|Baseline|TPF Induction Chemotherapy Followed by Chemoradiotherapy|Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
309425|NCT01221753|P1|Participant Flow|TPF Induction Chemotherapy Followed by Chemoradiotherapy|Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
309426|NCT01221753|O1|Outcome|TPF Induction Chemotherapy Followed by Chemoradiotherapy|Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
309427|NCT01221753|O1|Outcome|TPF Induction Chemotherapy Followed by Chemoradiotherapy|Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
309428|NCT01221753|E1|Reported Event|TPF Induction Chemotherapy Followed by Chemoradiotherapy|Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
309429|NCT01221727|B3|Baseline|Total|Total of all reporting groups
309430|NCT01221727|B2|Baseline|Midazolam Only|2 mg oral dose of Midazolam on Day 1 and Day 16. Out of 9 subjects enrolled and randomized, 8 subjects received investigation product.
309431|NCT01221727|B1|Baseline|Midazolam With Denosumab|2 mg oral dose of Midazolam on Day 1 and Day 16, 60 mg subcutaneous dose of Denosumab on Day 2. Out of 21 subjects enrolled and randomized, 19 subjects received investigation product.
309432|NCT01221727|P2|Participant Flow|Midazolam Only|2 mg oral dose of Midazolam on Day 1 and Day 16.
309433|NCT01221727|P1|Participant Flow|Midazolam With Denosumab|2 mg oral dose of Midazolam on Day 1 and Day 16, 60 mg subcutaneous dose of Denosumab on Day 2
309434|NCT01221727|O1|Outcome|Midazolam Only|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16
309435|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16, and 60 mg subcutaneous dose of Denosumab on day 2
309436|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 (serving as a reference point) and day 16 (serving as a test point), and 60 mg subcutaneous dose of Denosumab on day 2
311523|NCT01217112|O5|Outcome|Placebo|Contains excipients only
309444|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 (serving as a reference point) and day 16 (serving as a test point), and 60 mg subcutaneous dose of Denosumab on day 2
309445|NCT01221727|E6|Reported Event|Midazolam Only Group With Midazolam 2mg on Day 16|
309446|NCT01221727|E5|Reported Event|Midazolam Only Group With Midazolam 2mg on Day 2-15|
309447|NCT01221727|E4|Reported Event|Midazolam Only Group With Midazolam 2mg on Day 1|
309448|NCT01221727|E3|Reported Event|Midazolam With Denosumab Group With Midazolam 2mg on Day 16|
309449|NCT01221727|E2|Reported Event|Midazolam With Denosumab Group With Denosumab 60mg on Day 2-15|
309450|NCT01221727|E1|Reported Event|Midazolam With Denosumab Group With Midazolam 2mg on Day 1|
309451|NCT01221623|B3|Baseline|Total|Total of all reporting groups
309452|NCT01221623|B2|Baseline|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309453|NCT01221623|B1|Baseline|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309454|NCT01221623|P2|Participant Flow|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309455|NCT01221623|P1|Participant Flow|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309456|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309457|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309458|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309459|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309460|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309461|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309462|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309463|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309464|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309465|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309625|NCT01221272|O2|Outcome|Placebo|Placebo treatment period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
309466|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309467|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309468|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309469|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309470|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309471|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309472|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309473|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309474|NCT01221623|E2|Reported Event|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309475|NCT01221623|E1|Reported Event|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309476|NCT01221597|B3|Baseline|Total|Total of all reporting groups
309477|NCT01221597|B2|Baseline|Placebo|Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
309478|NCT01221597|B1|Baseline|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309479|NCT01221597|P2|Participant Flow|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
309480|NCT01221597|P1|Participant Flow|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309481|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
309482|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309669|NCT01220869|B1|Baseline|Degarelix|Degarelix 240/80 mg dosing regimen (240 mg is the initiation dose, the 80 mg is the maintenance dose)
311524|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
309483|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
309484|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309485|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
309486|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309487|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
309488|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309489|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
309490|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309491|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
309492|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309493|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
309494|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309495|NCT01221597|O2|Outcome|Placebo|Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
309496|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309497|NCT01221597|O2|Outcome|Placebo|Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
309498|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309499|NCT01221597|E2|Reported Event|Placebo|Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
309500|NCT01221597|E1|Reported Event|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
309501|NCT01221441|B3|Baseline|Total|Total of all reporting groups
309502|NCT01221441|B2|Baseline|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
309503|NCT01221441|B1|Baseline|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
309504|NCT01221441|P2|Participant Flow|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
309505|NCT01221441|P1|Participant Flow|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
309506|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
309507|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
309508|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
309509|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
309510|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
309511|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
309512|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
309513|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
309514|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
309515|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
309516|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
309517|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
309518|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
309519|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
309520|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
309521|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
309522|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
309523|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
309524|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
309525|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
309526|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
309527|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
309528|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
309529|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
309530|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
309531|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
309532|NCT01221441|E2|Reported Event|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
309533|NCT01221441|E1|Reported Event|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
309534|NCT01221363|B3|Baseline|Total|Total of all reporting groups
309535|NCT01221363|B2|Baseline|Control Group|No intervention control group
309536|NCT01221363|B1|Baseline|Lifestyle Counselling|"Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period.~Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention."
309537|NCT01221363|P2|Participant Flow|Control Group|No intervention control group
309538|NCT01221363|P1|Participant Flow|Lifestyle Counselling|"Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period.~Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention."
309539|NCT01221363|O2|Outcome|Control Group|No intervention control group
309712|NCT01220466|B1|Baseline|Hyperopia With or Without Astigmatism|"Hyperopia with and without astigmatism with MRSE up to~+9.00 D, with cylinder between 0.00 and +6.00 D."
309540|NCT01221363|O1|Outcome|Lifestyle Counselling|"Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period.~Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention."
309541|NCT01221363|O2|Outcome|Control Group|No intervention control group
309542|NCT01221363|O1|Outcome|Lifestyle Counselling|"Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period.~Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention."
309543|NCT01221363|E2|Reported Event|Control Group|No intervention control group
309544|NCT01221363|E1|Reported Event|Lifestyle Counselling|"Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period.~Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention."
309545|NCT01221350|B3|Baseline|Total|Total of all reporting groups
309546|NCT01221350|B2|Baseline|Placebo|Placebo (two 300 mg capsules filled with vehicle) orally once daily in the morning during 60 days
309547|NCT01221350|B1|Baseline|Lipoic Acid|Lipoic acid (ALA) 600 mg oral dose (two 300 mg capsules) once daily in the morning during 60 days
309548|NCT01221350|P2|Participant Flow|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
309549|NCT01221350|P1|Participant Flow|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
309550|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
309551|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
309552|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
309553|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
309554|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
309555|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
309556|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
309557|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
309558|NCT01221350|O2|Outcome|Placebo|Placebo (two 300 mg capsules filled with vehicle) orally once daily in the morning during 60 days
309559|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid (ALA) 600 mg oral dose (two 300 mg capsules) once daily in the morning during 60 days
309560|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
309561|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
309562|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
309563|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
309564|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
309565|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
309566|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
309567|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
309568|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
309569|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
309570|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
309571|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
309572|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
309573|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
309574|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
309575|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
309576|NCT01221350|O2|Outcome|Placebo|Placebo (two 300 mg capsules filled with vehicle) orally once daily in the morning during 60 days
309577|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid (ALA) 600 mg oral dose (two 300 mg capsules) once daily in the morning during 60 days
309578|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
309579|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
309580|NCT01221350|O2|Outcome|Placebo|Placebo (two 300 mg capsules filled with vehicle) orally once daily in the morning during 60 days
309581|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid (ALA) 600 mg oral dose (two 300 mg capsules) once daily in the morning during 60 days
309582|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
309583|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
309584|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
309585|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
309586|NCT01221350|E2|Reported Event|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
309587|NCT01221350|E1|Reported Event|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
309588|NCT01221311|B3|Baseline|Total|Total of all reporting groups
309670|NCT01220869|P1|Participant Flow|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
309589|NCT01221311|B2|Baseline|Plastic Stent|Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria.
309590|NCT01221311|B1|Baseline|Fully Covered Metallic Stent|"Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist.~Fully covered Metallic Stent: Covered Wallflex Biliary (TM)"
309591|NCT01221311|P2|Participant Flow|Plastic Stent|"Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria (details below).~Plastic Stent: Patients randomized to the PS group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and one or two PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal"
309592|NCT01221311|P1|Participant Flow|Fully Covered Metallic Stent|"Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist.~Fully covered Metallic Stent: Covered Wallflex Biliary (TM)"
309593|NCT01221311|O2|Outcome|Plastic Stent|"Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria (details below).~Plastic Stent: Patients randomized to the PS group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and one or two PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal"
309594|NCT01221311|O1|Outcome|Fully Covered Metallic Stent|"Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist.~Fully covered Metallic Stent: Covered Wallflex Biliary (TM)"
309595|NCT01221311|E2|Reported Event|Plastic Stent|Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria.
309596|NCT01221311|E1|Reported Event|Fully Covered Metallic Stent|"Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist.~Fully covered Metallic Stent: Covered Wallflex Biliary (TM)"
309597|NCT01221298|B1|Baseline|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
309598|NCT01221298|P1|Participant Flow|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
309599|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
309600|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
309601|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
309602|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
309603|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
309604|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
309605|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
309606|NCT01221298|E1|Reported Event|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
309607|NCT01221285|B1|Baseline|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 mL of extract at a concentration of 1:20 wt/vol.
309608|NCT01221285|P1|Participant Flow|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
309609|NCT01221285|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
309610|NCT01221285|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
309611|NCT01221285|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
309612|NCT01221285|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
309613|NCT01221285|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
309614|NCT01221285|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
309615|NCT01221285|E1|Reported Event|Experimental: German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
309616|NCT01221272|B1|Baseline|All Participants|"Baseline characteristics were analyzed as a single group (Safety Analysis Set). All participants were assigned to complete the same treatment periods in the same manner.~Ranolazine Treatment Period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Placebo Treatment Period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
309617|NCT01221272|P2|Participant Flow|Placebo/Ranolazine|"Period 1: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Period 2: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
309618|NCT01221272|P1|Participant Flow|Ranolazine/Placebo|"Period 1: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise gated single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) study.~Period 2: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
309619|NCT01221272|O2|Outcome|Placebo/Ranolazine|"Period 1: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Period 2: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
309620|NCT01221272|O1|Outcome|Ranolazine/Placebo|"Period 1: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Period 2: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
309621|NCT01221272|O2|Outcome|Placebo/Ranolazine|"Period 1: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Period 2: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
309622|NCT01221272|O1|Outcome|Ranolazine/Placebo|"Period 1: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Period 2: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
309623|NCT01221272|O2|Outcome|Placebo/Ranolazine|"Period 1: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Period 2: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
309624|NCT01221272|O1|Outcome|Ranolazine/Placebo|"Period 1: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Period 2: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
309821|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309626|NCT01221272|O1|Outcome|Ranolazine|Ranolazine treatment period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
309627|NCT01221272|O2|Outcome|Placebo|Placebo treatment period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
309628|NCT01221272|O1|Outcome|Ranolazine|Ranolazine treatment period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
309629|NCT01221272|E3|Reported Event|Onset at Any Time Following Ranolazine|"This reporting group includes participants dosed with ranolazine and their events with onset at any time following ranolazine treatment.~Ranolazine Treatment Period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Placebo Treatment Period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
309630|NCT01221272|E2|Reported Event|Onset Following Placebo|"This reporting group includes participants dosed with placebo and their events for which the last dosed treatment was placebo, ie, events with onset during the placebo treatment period or during post-placebo treatment period follow-up.~Ranolazine Treatment Period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Placebo Treatment Period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
309631|NCT01221272|E1|Reported Event|Onset Following Ranolazine|"This reporting group includes participants dosed with ranolazine and their events for which the last dosed treatment was ranolazine, ie, events with onset during the ranolazine treatment period or during post-ranolazine treatment period follow-up.~Ranolazine Treatment Period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Placebo Treatment Period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
309632|NCT01221090|B5|Baseline|Total|Total of all reporting groups
309633|NCT01221090|B4|Baseline|Control|Usual Care
309634|NCT01221090|B3|Baseline|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
309635|NCT01221090|B2|Baseline|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
309636|NCT01221090|B1|Baseline|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
309637|NCT01221090|P4|Participant Flow|Control|Usual Care
309638|NCT01221090|P3|Participant Flow|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
309639|NCT01221090|P2|Participant Flow|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
309640|NCT01221090|P1|Participant Flow|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
309641|NCT01221090|O4|Outcome|Control|Usual Care
309642|NCT01221090|O3|Outcome|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
309643|NCT01221090|O2|Outcome|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
309644|NCT01221090|O1|Outcome|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
309645|NCT01221090|O4|Outcome|Control|Usual Care
309646|NCT01221090|O3|Outcome|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
309647|NCT01221090|O2|Outcome|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
309648|NCT01221090|O1|Outcome|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
309649|NCT01221090|O4|Outcome|Control|Usual Care
309650|NCT01221090|O3|Outcome|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
309651|NCT01221090|O2|Outcome|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
309652|NCT01221090|O1|Outcome|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
309653|NCT01221090|O4|Outcome|Control|Usual Care
309654|NCT01221090|O3|Outcome|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
309655|NCT01221090|O2|Outcome|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
309656|NCT01221090|O1|Outcome|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
309657|NCT01221090|O4|Outcome|Control|Usual Care
309658|NCT01221090|O3|Outcome|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
309659|NCT01221090|O2|Outcome|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
309660|NCT01221090|O1|Outcome|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
309661|NCT01221090|E4|Reported Event|Control|Usual Care
309662|NCT01221090|E3|Reported Event|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
309663|NCT01221090|E2|Reported Event|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
309664|NCT01221090|E1|Reported Event|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
309665|NCT01220973|B1|Baseline|Atorvastatin and Celecoxib|"atorvastatin calcium~celecoxib~laboratory biomarker analysis"
309666|NCT01220973|P1|Participant Flow|Atorvastatin and Celecoxib|"atorvastatin calcium~celecoxib~laboratory biomarker analysis"
309667|NCT01220973|O1|Outcome|Atorvastatin and Celecoxib|"atorvastatin calcium~celecoxib~laboratory biomarker analysis"
309668|NCT01220973|E1|Reported Event|Atorvastatin and Celecoxib|"atorvastatin calcium~celecoxib~laboratory biomarker analysis"
309671|NCT01220869|O1|Outcome|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
309672|NCT01220869|O1|Outcome|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
309673|NCT01220869|O1|Outcome|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
309674|NCT01220869|O1|Outcome|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
309675|NCT01220869|O1|Outcome|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
309676|NCT01220869|E1|Reported Event|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
309677|NCT01220739|B3|Baseline|Total|Total of all reporting groups
309678|NCT01220739|B2|Baseline|Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
309679|NCT01220739|B1|Baseline|Sham Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
309680|NCT01220739|P2|Participant Flow|Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
309681|NCT01220739|P1|Participant Flow|Sham Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
309682|NCT01220739|O2|Outcome|Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
309683|NCT01220739|O1|Outcome|Sham Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
309684|NCT01220739|O2|Outcome|Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
309710|NCT01220466|B3|Baseline|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D ) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
309711|NCT01220466|B2|Baseline|Myopia With or Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
309685|NCT01220739|O1|Outcome|Sham Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
309686|NCT01220739|E2|Reported Event|Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
309687|NCT01220739|E1|Reported Event|Sham Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
309688|NCT01220609|B1|Baseline|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
309689|NCT01220609|P1|Participant Flow|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
309690|NCT01220609|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
309691|NCT01220609|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
309692|NCT01220609|O6|Outcome|Grade 5 (CTCAE v 4.0)|Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
309693|NCT01220609|O5|Outcome|Grade 4 (CTCAE v 4.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
309694|NCT01220609|O4|Outcome|Grade 3 (CTCAE v 4.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
309695|NCT01220609|O3|Outcome|Grade 2 (CTCAE v 4.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
309696|NCT01220609|O2|Outcome|Grade 1 (CTCAE v 4.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
309697|NCT01220609|O1|Outcome|Grade 0|Number of patients who did not experience the specified AE.
309698|NCT01220609|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
309699|NCT01220609|E1|Reported Event|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
309700|NCT01220557|B3|Baseline|Total|Total of all reporting groups
309701|NCT01220557|B2|Baseline|Control Group|The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
309702|NCT01220557|B1|Baseline|PRIMAS Group|PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material
309703|NCT01220557|P2|Participant Flow|Control Group|The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
309704|NCT01220557|P1|Participant Flow|PRIMAS Group|PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material
309705|NCT01220557|O2|Outcome|Control Group|The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
309706|NCT01220557|O1|Outcome|PRIMAS Group|PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material
309707|NCT01220557|E2|Reported Event|Control Group|"The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.~DTTP: The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material."
309708|NCT01220557|E1|Reported Event|PRIMAS Group|"PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material~PRIMAS: PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material"
309709|NCT01220466|B4|Baseline|Total|Total of all reporting groups
309713|NCT01220466|P3|Participant Flow|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D ) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
309714|NCT01220466|P2|Participant Flow|Myopia With or Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
309715|NCT01220466|P1|Participant Flow|Hyperopia With or Without Astigmatism|"Hyperopia with and without astigmatism with MRSE up to~+9.00 D, with cylinder between 0.00 and +6.00 D."
309716|NCT01220466|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
309717|NCT01220466|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
309718|NCT01220466|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
309719|NCT01220466|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
309720|NCT01220466|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
309721|NCT01220466|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
309722|NCT01220466|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
309723|NCT01220466|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
309724|NCT01220466|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
309725|NCT01220466|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
309726|NCT01220466|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
309727|NCT01220466|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
309728|NCT01220466|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
309729|NCT01220466|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
309730|NCT01220466|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
309731|NCT01220466|E3|Reported Event|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
309732|NCT01220466|E2|Reported Event|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
309733|NCT01220466|E1|Reported Event|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
309734|NCT01220414|B3|Baseline|Total|Total of all reporting groups
309735|NCT01220414|B2|Baseline|Placebo Then Naltrxone|
309736|NCT01220414|B1|Baseline|Naltrexone Then Placebo|All participants completed both naltrexone and placebo conditions
309737|NCT01220414|P4|Participant Flow|Females, Placebo Then Naltrexone|
309738|NCT01220414|P3|Participant Flow|Females, Naltrexone Then Placebo|
309739|NCT01220414|P2|Participant Flow|Males, Placebo Then Naltrexone|
309740|NCT01220414|P1|Participant Flow|Males, Naltrexone Then Placebo|
309741|NCT01220414|O4|Outcome|Females, Naltrexone|
309742|NCT01220414|O3|Outcome|Men, Naltrexone|
309743|NCT01220414|O2|Outcome|Women, Placebo|
309744|NCT01220414|O1|Outcome|Men, Placebo|
309745|NCT01220414|E1|Reported Event|Naltrexone and Placebo|Participants completed both naltrexone and placebo conditions
309746|NCT01220401|B1|Baseline|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.~exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
309747|NCT01220401|P1|Participant Flow|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.~exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
309748|NCT01220401|O1|Outcome|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.~exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Treatment consists of psychoeducation, relaxation techniques, mindfulness, exposure to nightmare content, and rescription of nightmare to make it less distressing.~Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
309749|NCT01220401|O1|Outcome|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.~exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Treatment consists of psychoeducation, relaxation techniques, mindfulness, exposure to nightmare content, and rescription of nightmare to make it less distressing.~Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
310092|NCT01219855|O5|Outcome|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
309750|NCT01220401|O1|Outcome|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.~exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Treatment consists of psychoeducation, relaxation techniques, mindfulness, exposure to nightmare content, and rescription of nightmare to make it less distressing.~Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
309751|NCT01220401|O1|Outcome|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.~exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Treatment consists of psychoeducation, relaxation techniques, mindfulness, exposure to nightmare content, and rescription of nightmare to make it less distressing.~Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
309752|NCT01220401|E1|Reported Event|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.~exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
309753|NCT01220297|B3|Baseline|Total|Total of all reporting groups
309754|NCT01220297|B2|Baseline|GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after therapeutic regimen of cyclophosphamide (Cyclo) chemotherapy and fractionated total body irradiation (FTBI)
309755|NCT01220297|B1|Baseline|GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after chemotherapeutic regimen of carmustine (BCNU) + etoposide (VP-16) + cyclophosphamide (Cyclo)
309756|NCT01220297|P1|Participant Flow|Graft-vs-Host Disease (GvHD) Prophlyaxis|Sirolimus & Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative
309757|NCT01220297|O2|Outcome|GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after therapeutic regimen of cyclophosphamide (Cyclo) chemotherapy and fractionated total body irradiation (FTBI)
309758|NCT01220297|O1|Outcome|GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after chemotherapeutic regimen of carmustine (BCNU) + etoposide (VP-16) + cyclophosphamide (Cyclo)
309759|NCT01220297|O2|Outcome|GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after therapeutic regimen of cyclophosphamide (Cyclo) chemotherapy and fractionated total body irradiation (FTBI)
309760|NCT01220297|O1|Outcome|GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after chemotherapeutic regimen of carmustine (BCNU) + etoposide (VP-16) + cyclophosphamide (Cyclo)
309761|NCT01220297|O2|Outcome|GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after therapeutic regimen of cyclophosphamide (Cyclo) chemotherapy and fractionated total body irradiation (FTBI)
309762|NCT01220297|O1|Outcome|GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after chemotherapeutic regimen of carmustine (BCNU) + etoposide (VP-16) + cyclophosphamide (Cyclo)
309763|NCT01220297|O2|Outcome|GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after therapeutic regimen of cyclophosphamide (Cyclo) chemotherapy and fractionated total body irradiation (FTBI)
309764|NCT01220297|O1|Outcome|GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after chemotherapeutic regimen of carmustine (BCNU) + etoposide (VP-16) + cyclophosphamide (Cyclo)
309765|NCT01220297|O2|Outcome|GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after therapeutic regimen of cyclophosphamide (Cyclo) chemotherapy and fractionated total body irradiation (FTBI)
309766|NCT01220297|O1|Outcome|GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after chemotherapeutic regimen of carmustine (BCNU) + etoposide (VP-16) + cyclophosphamide (Cyclo)
309767|NCT01220297|E2|Reported Event|GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after therapeutic regimen of cyclophosphamide (Cyclo) chemotherapy and fractionated total body irradiation (FTBI)
309768|NCT01220297|E1|Reported Event|GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after chemotherapeutic regimen of carmustine (BCNU) + etoposide (VP-16) + cyclophosphamide (Cyclo)
309769|NCT01220180|B4|Baseline|Total|Total of all reporting groups
309770|NCT01220180|B3|Baseline|Pregabalin: Fibromyalgia|Pregabalin capsules administered orally starting with a dose of 300 to 450 mg/day in adult participants with fibromyalgia.
309771|NCT01220180|B2|Baseline|Pregabalin: Neuropathic Pain|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with Neuropathic pain (NeP).
309772|NCT01220180|B1|Baseline|Pregabalin: Epilepsy|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy.
309773|NCT01220180|P1|Participant Flow|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 milligram per day (mg/day) which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
309774|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
311525|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
309775|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
309776|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
309777|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
309778|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
309779|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
309780|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
309781|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
309782|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
309783|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
309784|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
309785|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
309786|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
309787|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
309788|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
309789|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
309790|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
309791|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
309792|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
309793|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
309794|NCT01220180|E1|Reported Event|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
309795|NCT01220128|B8|Baseline|Total|Total of all reporting groups
309796|NCT01220128|B7|Baseline|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309797|NCT01220128|B6|Baseline|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
310102|NCT01219855|O5|Outcome|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
309798|NCT01220128|B5|Baseline|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309799|NCT01220128|B4|Baseline|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309800|NCT01220128|B3|Baseline|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309801|NCT01220128|B2|Baseline|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309802|NCT01220128|B1|Baseline|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
309803|NCT01220128|P7|Participant Flow|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309804|NCT01220128|P6|Participant Flow|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
309805|NCT01220128|P5|Participant Flow|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309806|NCT01220128|P4|Participant Flow|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309807|NCT01220128|P3|Participant Flow|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309808|NCT01220128|P2|Participant Flow|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309809|NCT01220128|P1|Participant Flow|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
309810|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309811|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
309812|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309813|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309814|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309815|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309816|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
309817|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309818|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
309819|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309820|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
311526|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
309822|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309823|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
309824|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309825|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
309826|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309827|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309828|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309829|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309830|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
309831|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309832|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
309833|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309834|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309835|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309836|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309837|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
309838|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309839|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
309840|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309841|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309842|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309843|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309844|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
310093|NCT01219855|O4|Outcome|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
309845|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309846|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
309847|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309848|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309849|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309850|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309851|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
309852|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309853|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
309854|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309855|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309856|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309857|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309858|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
309859|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309860|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
309861|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309862|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309863|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309864|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309865|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
309866|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309867|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
311527|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
309868|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309869|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309870|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309871|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309872|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
309873|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309874|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
309875|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309876|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309877|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309878|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309879|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
309880|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309881|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
309882|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309883|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309884|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309885|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309886|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
309887|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309888|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
309889|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309890|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309891|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309892|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309893|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
309894|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309895|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
309896|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309897|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309898|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309899|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309900|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
309901|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309902|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
309903|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309904|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309905|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309906|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309907|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
309908|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309909|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
309910|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309911|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309912|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309913|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309914|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
310094|NCT01219855|O3|Outcome|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
309915|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309916|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
309917|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309918|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309919|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309920|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309921|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
309922|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309923|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
309924|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309925|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309926|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309927|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309928|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
309929|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309930|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
309931|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309932|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309933|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309934|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309935|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
309936|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309937|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
311528|NCT01217112|O5|Outcome|Placebo|Contains excipients only
309938|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309939|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309940|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309941|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309942|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
309943|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309944|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
309945|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309946|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309947|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309948|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309949|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
309950|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309951|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
309952|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309953|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309954|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309955|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309956|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
309957|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309958|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
309959|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309960|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309961|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309962|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309963|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
309964|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309965|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
309966|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309967|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309968|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309969|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309970|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
309971|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309972|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
309973|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309974|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309975|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309976|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309977|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
309978|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309979|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
309980|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309981|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309982|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024AI and intravenous chemotherapy.
309983|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309984|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
310095|NCT01219855|O2|Outcome|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
309985|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309986|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
309987|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309988|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309989|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024AI and intravenous chemotherapy.
309990|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309991|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
309992|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309993|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
309994|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309995|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309996|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
309997|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
309998|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
309999|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
310000|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
310001|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
310002|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
310003|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
310004|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
310005|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule
310006|NCT01220128|E7|Reported Event|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
310007|NCT01220128|E6|Reported Event|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
310008|NCT01220128|E5|Reported Event|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
310009|NCT01220128|E4|Reported Event|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
310010|NCT01220128|E3|Reported Event|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
310011|NCT01220128|E2|Reported Event|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
310012|NCT01220128|E1|Reported Event|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
310013|NCT01219985|B1|Baseline|Investigation Arm|Patients included in the trial. n=50
310014|NCT01219985|P1|Participant Flow|Investigation Arm|Patients definitely included in the trial. All these patients underwent non-gated and gated PET/CT as well as hepatic surgery. In addition, histological analysis of the resected lesions were also obtained.
310015|NCT01219985|O1|Outcome|SUVmax Study|SUVmax measurement for each lesion in Ungated and CT-Based PET images. SUVmax was obtained automatically in a volume of interest encompassing the entire lesion
310016|NCT01219985|O2|Outcome|CT-Based Per-lesion Sensitivity|CT-Based PET images results were compared with pathological analyses
310017|NCT01219985|O1|Outcome|Ungated Per-lesion Sensitivity|Ungated PET images results were compared with pathological analyses
310018|NCT01219985|E1|Reported Event|Investigation Arm|Patients included in the trial. n=50
310019|NCT01219933|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310020|NCT01219933|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (IV) once every 4 weeks and methotrexate (MTX) 7.5 to 25 mg per week (mg/week; per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received an oral glucocorticoid (GC; no product/dose limitation) until low disease activity (LDA; defined as Disease Activity Score Based on 28-Joint Count and C-reactive protein [DAS28-CRP] less than or equal to [≤]3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to methylprednisolone (MP) tablets, by mouth (PO). MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be greater than or equal to [≥]1 mg and ≤20 mg per day [mg/day]), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment
310021|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310022|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310023|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310024|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310096|NCT01219855|O1|Outcome|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
310097|NCT01219855|O5|Outcome|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
310025|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310026|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310027|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310028|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310029|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310030|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310031|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310032|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310033|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310034|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310098|NCT01219855|O4|Outcome|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
310035|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310036|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310037|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310038|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310039|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310040|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310041|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310042|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310043|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310044|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310099|NCT01219855|O3|Outcome|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
310045|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310046|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310047|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310048|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310049|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310050|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310051|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310052|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310053|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310054|NCT01219933|E2|Reported Event|Interventional Phase|All participants who maintained LDA from V2 to V3 were included in the interventional phase for reduction of GC. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
310100|NCT01219855|O2|Outcome|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
310101|NCT01219855|O1|Outcome|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
310055|NCT01219933|E1|Reported Event|Noninterventional Phase|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week according to local standard of care and at the investigator's discretion (or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months.
310056|NCT01219881|B3|Baseline|Total|Total of all reporting groups
310057|NCT01219881|B2|Baseline|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.~Desflurane : 5.4 to 7.4% desflurane"
310058|NCT01219881|B1|Baseline|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.~Sevoflurane : 1.4 to 2.5% Sevoflurane"
310059|NCT01219881|P2|Participant Flow|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.~Sevoflurane : 1.4 to 2.5% Sevoflurane"
310060|NCT01219881|P1|Participant Flow|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.~Desflurane : 5.4 to 7.4% desflurane"
310061|NCT01219881|O2|Outcome|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.~Desflurane : 5.4 to 7.4% desflurane"
310062|NCT01219881|O1|Outcome|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.~Sevoflurane : 1.4 to 2.5% Sevoflurane"
310063|NCT01219881|O2|Outcome|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.~Desflurane : 5.4 to 7.4% desflurane"
310064|NCT01219881|O1|Outcome|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.~Sevoflurane : 1.4 to 2.5% Sevoflurane"
310065|NCT01219881|O2|Outcome|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.~Desflurane : 5.4 to 7.4% desflurane"
310066|NCT01219881|O1|Outcome|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.~Sevoflurane : 1.4 to 2.5% Sevoflurane"
310067|NCT01219881|O2|Outcome|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.~Desflurane : 5.4 to 7.4% desflurane"
310068|NCT01219881|O1|Outcome|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.~Sevoflurane : 1.4 to 2.5% Sevoflurane"
310069|NCT01219881|E2|Reported Event|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.~Desflurane : 5.4 to 7.4% desflurane"
310070|NCT01219881|E1|Reported Event|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.~Sevoflurane : 1.4 to 2.5% Sevoflurane"
310071|NCT01219855|B6|Baseline|Total|Total of all reporting groups
310072|NCT01219855|B5|Baseline|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
310073|NCT01219855|B4|Baseline|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
310074|NCT01219855|B3|Baseline|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
310075|NCT01219855|B2|Baseline|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
310076|NCT01219855|B1|Baseline|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
310077|NCT01219855|P5|Participant Flow|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
310078|NCT01219855|P4|Participant Flow|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
310079|NCT01219855|P3|Participant Flow|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
310080|NCT01219855|P2|Participant Flow|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
310081|NCT01219855|P1|Participant Flow|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
310082|NCT01219855|O5|Outcome|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
310083|NCT01219855|O4|Outcome|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
310084|NCT01219855|O3|Outcome|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
310085|NCT01219855|O2|Outcome|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
310086|NCT01219855|O1|Outcome|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
310087|NCT01219855|O5|Outcome|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
310088|NCT01219855|O4|Outcome|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
310089|NCT01219855|O3|Outcome|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
310090|NCT01219855|O2|Outcome|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
310091|NCT01219855|O1|Outcome|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
310103|NCT01219855|O4|Outcome|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
310104|NCT01219855|O3|Outcome|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
310105|NCT01219855|O2|Outcome|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
310106|NCT01219855|O1|Outcome|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
310107|NCT01219855|O5|Outcome|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
310108|NCT01219855|O4|Outcome|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
310109|NCT01219855|O3|Outcome|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
310110|NCT01219855|O2|Outcome|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
310111|NCT01219855|O1|Outcome|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
310112|NCT01219855|E4|Reported Event|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
310113|NCT01219855|E3|Reported Event|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
310114|NCT01219855|E2|Reported Event|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
310115|NCT01219855|E1|Reported Event|Cohorts 1,2: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
310116|NCT01219777|B1|Baseline|Arm I|"Chemotherapy Cycles 1-3: All patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. Cycles will be administered every 21 days.~Chemotherapy Cycle 4: Patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4.~Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab.~Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of"
310117|NCT01219777|P1|Participant Flow|Carboplatin + Weekly Paclitaxel and Bevacizumab|"Chemotherapy Cycles 1-3: After study enrollment all patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. The cycles will be administered every 21 days.~Chemotherapy Cycle 4: Enrolled patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4.~Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab.~Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of"
310118|NCT01219777|O1|Outcome|Arm I|"Chemotherapy Cycles 1-3: All patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. Cycles will be administered every 21 days.~Chemotherapy Cycle 4: Patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4.~Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab.~Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of"
310119|NCT01219777|O1|Outcome|Arm I|"Chemotherapy Cycles 1-3: After study enrollment all patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. The cycles will be administered every 21 days.~Chemotherapy Cycle 4: Enrolled patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4.~Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab.~Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of"
310120|NCT01219777|E1|Reported Event|Arm I|"Chemotherapy Cycles 1-3: All patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. Cycles will be administered every 21 days.~Chemotherapy Cycle 4: Patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4.~Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab.~Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of"
310121|NCT01219738|B1|Baseline|Asthma|"asthmatic subject received different doses of inhaled budesonide~Budesonide: A single inhaled dose of 360ug budesonide from a DPI.~Budesonide: A single inhaled dose of 720ug budesonide from a DPI.~Budesonide: A single dose of 1440ug of the budesonide from DPI.~Budesonide: 720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.~Placebo: A single inhaled dose of placebo from a DPI."
311444|NCT01217307|O2|Outcome|Placebo|"Placebo twice daily during 4 months~Placebo: Placebo twice daily during 4 months"
310122|NCT01219738|P1|Participant Flow|All Study Participants|"asthmatic subject received different doses of inhaled budesonide~Budesonide: A single inhaled dose of 360ug budesonide from a DPI.~Budesonide: A single inhaled dose of 720ug budesonide from a DPI.~Budesonide: A single dose of 1440ug of the budesonide from DPI.~Budesonide: 720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.~Placebo: A single inhaled dose of placebo from a DPI."
310123|NCT01219738|O5|Outcome|Placebo|A single inhaled dose of placebo from a DPI
310124|NCT01219738|O4|Outcome|720ug of Budesonide 4 Times|Budesonide: 720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.
310125|NCT01219738|O3|Outcome|Budesonide 1440 ug|Budesonide: A single inhaled dose of 1440ug budesonide from a DPI.
310126|NCT01219738|O2|Outcome|Budesonide 720 ug|Budesonide: A single inhaled dose of 720ug budesonide from a DPI.
310127|NCT01219738|O1|Outcome|Budesonide 360 ug|Budesonide: A single inhaled dose of 360ug budesonide from a DPI.
310128|NCT01219738|O5|Outcome|Placebo|Placebo: A single inhaled dose of placebo from a DPI
310129|NCT01219738|O4|Outcome|Budesonide 720ug 4 Times|Budesonide: 720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.
310130|NCT01219738|O3|Outcome|Budesonide 1440ug|Budesonide: A single dose of 1440ug of the budesonide from DPI.
310131|NCT01219738|O2|Outcome|Budesonide 720ug|Budesonide: A single inhaled dose of 720ug budesonide from a DPI.
310132|NCT01219738|O1|Outcome|Budesonide 360ug|Budesonide: A single inhaled dose of 360ug budesonide from a DPI.
310133|NCT01219738|E1|Reported Event|All Study Participants|Budesonide:was given in different doses
310134|NCT01219673|B9|Baseline|Total|Total of all reporting groups
310135|NCT01219673|B8|Baseline|Armodafinil + Minocycline + Bupropion|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
310136|NCT01219673|B7|Baseline|Minocycline + Bupropion|"Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
310137|NCT01219673|B6|Baseline|Armodafinil + Bupropion|"Armodafinil 150 mg by mouth once a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Bupropion: 100 mg by mouth twice a day."
310138|NCT01219673|B5|Baseline|Armodafinil + Minocycline|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day."
310139|NCT01219673|B4|Baseline|Bupropion|"Bupropion 100 mg by mouth two times a day.~Bupropion: 100 mg by mouth twice a day."
310140|NCT01219673|B3|Baseline|Minocycline|"Minocycline 100 mg by muth two times a day.~Minocycline: 100 mg by mouth twice a day."
310141|NCT01219673|B2|Baseline|Armodafinil|"Armodafinil 150 mg by mouth once a day.~Armodafinil: 150 mg by mouth once a day."
310142|NCT01219673|B1|Baseline|Placebo|"Placebo by mouth 2 times every day.~Placebo: 1 by mouth twice a day."
310143|NCT01219673|P8|Participant Flow|Armodafinil + Minocycline + Bupropion|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
310144|NCT01219673|P7|Participant Flow|Minocycline + Bupropion|"Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
310145|NCT01219673|P6|Participant Flow|Armodafinil + Bupropion|"Armodafinil 150 mg by mouth once a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Bupropion: 100 mg by mouth twice a day."
310146|NCT01219673|P5|Participant Flow|Armodafinil + Minocycline|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day."
310147|NCT01219673|P4|Participant Flow|Bupropion|"Bupropion 100 mg by mouth two times a day.~Bupropion: 100 mg by mouth twice a day."
310148|NCT01219673|P3|Participant Flow|Minocycline|"Minocycline 100 mg by muth two times a day.~Minocycline: 100 mg by mouth twice a day."
310149|NCT01219673|P2|Participant Flow|Armodafinil|"Armodafinil 150 mg by mouth once a day.~Armodafinil: 150 mg by mouth once a day."
310150|NCT01219673|P1|Participant Flow|Placebo|"Placebo by mouth 2 times every day.~Placebo: 1 by mouth twice a day."
310151|NCT01219673|O8|Outcome|Armodafinil + Minocycline + Bupropion|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
310152|NCT01219673|O7|Outcome|Minocycline + Bupropion|"Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
310153|NCT01219673|O6|Outcome|Armodafinil + Bupropion|"Armodafinil 150 mg by mouth once a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Bupropion: 100 mg by mouth twice a day."
310154|NCT01219673|O5|Outcome|Armodafinil + Minocycline|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day."
310155|NCT01219673|O4|Outcome|Bupropion|"Bupropion 100 mg by mouth two times a day.~Bupropion: 100 mg by mouth twice a day."
310156|NCT01219673|O3|Outcome|Minocycline|"Minocycline 100 mg by muth two times a day.~Minocycline: 100 mg by mouth twice a day."
310157|NCT01219673|O2|Outcome|Armodafinil|"Armodafinil 150 mg by mouth once a day.~Armodafinil: 150 mg by mouth once a day."
310158|NCT01219673|O1|Outcome|Placebo|"Placebo by mouth 2 times every day.~Placebo: 1 by mouth twice a day."
310159|NCT01219673|E8|Reported Event|Armodafinil + Minocycline + Bupropion|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
310160|NCT01219673|E7|Reported Event|Minocycline + Bupropion|"Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
311529|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
310161|NCT01219673|E6|Reported Event|Armodafinil + Bupropion|"Armodafinil 150 mg by mouth once a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Bupropion: 100 mg by mouth twice a day."
310162|NCT01219673|E5|Reported Event|Armodafinil + Minocycline|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day."
310163|NCT01219673|E4|Reported Event|Bupropion|"Bupropion 100 mg by mouth two times a day.~Bupropion: 100 mg by mouth twice a day."
310164|NCT01219673|E3|Reported Event|Minocycline|"Minocycline 100 mg by muth two times a day.~Minocycline: 100 mg by mouth twice a day."
310165|NCT01219673|E2|Reported Event|Armodafinil|"Armodafinil 150 mg by mouth once a day.~Armodafinil: 150 mg by mouth once a day."
310166|NCT01219673|E1|Reported Event|Placebo|"Placebo by mouth 2 times every day.~Placebo: 1 by mouth twice a day."
310167|NCT01218997|B3|Baseline|Total|Total of all reporting groups
310168|NCT01218997|B2|Baseline|Oral Naltrexone 50 mg|Oral tablet taken once each day for up to 1 year.
310169|NCT01218997|B1|Baseline|Medisorb Naltrexone 380 mg (VIVITROL)|Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
310170|NCT01218997|P2|Participant Flow|Oral Naltrexone 50 mg|Oral tablet taken once each day for up to 1 year.
310171|NCT01218997|P1|Participant Flow|Medisorb Naltrexone 380 mg (VIVITROL)|Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
310172|NCT01218997|O2|Outcome|Oral Naltrexone 50 mg|Oral tablet taken once each day for up to 1 year.
310173|NCT01218997|O1|Outcome|Medisorb Naltrexone 380 mg (VIVITROL)|Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
310174|NCT01218997|E2|Reported Event|Oral Naltrexone 50 mg|Oral tablet taken once each day for up to 1 year.
310175|NCT01218997|E1|Reported Event|Medisorb Naltrexone 380 mg (VIVITROL)|Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
310176|NCT01218984|B4|Baseline|Total|Total of all reporting groups
310177|NCT01218984|B3|Baseline|Medisorb Naltrexone 300 mg|Administered as a single gluteal IM injection
310178|NCT01218984|B2|Baseline|Medisorb Naltrexone 150 mg|Administered as a single gluteal IM injection
310179|NCT01218984|B1|Baseline|Medisorb Naltrexone 75 mg|Administered as a single gluteal intramuscular (IM) injection
310180|NCT01218984|P3|Participant Flow|Medisorb Naltrexone 300 mg|Administered as a single gluteal IM injection
310181|NCT01218984|P2|Participant Flow|Medisorb Naltrexone 150 mg|Administered as a single gluteal IM injection
310182|NCT01218984|P1|Participant Flow|Medisorb Naltrexone 75 mg|Administered as a single gluteal intramuscular (IM) injection
310183|NCT01218984|O3|Outcome|Medisorb Naltrexone 300 mg|Administered as a single gluteal IM injection
310184|NCT01218984|O2|Outcome|Medisorb Naltrexone 150 mg|Administered as a single gluteal IM injection
310185|NCT01218984|O1|Outcome|Medisorb Naltrexone 75 mg|Administered as a single gluteal intramuscular (IM) injection
310186|NCT01218984|E3|Reported Event|Medisorb Naltrexone 300 mg|Administered as a single gluteal IM injection
310187|NCT01218984|E2|Reported Event|Medisorb Naltrexone 150 mg|Administered as a single gluteal IM injection
310188|NCT01218984|E1|Reported Event|Medisorb Naltrexone 75 mg|Administered as a single gluteal intramuscular (IM) injection
310189|NCT01218971|B3|Baseline|Total|Total of all reporting groups
310190|NCT01218971|B2|Baseline|Medisorb Naltrexone 190 mg|
310191|NCT01218971|B1|Baseline|Medisorb Naltrexone 380 mg|
310192|NCT01218971|P2|Participant Flow|Medisorb Naltrexone 190 mg|
310193|NCT01218971|P1|Participant Flow|Medisorb Naltrexone 380 mg|
310194|NCT01218971|O2|Outcome|Medisorb Naltrexone 190 mg|
310195|NCT01218971|O1|Outcome|Medisorb Naltrexone 380 mg|
310196|NCT01218971|E6|Reported Event|190mg to 190mg|includes participants who received Medisorb naltrexone 190mg in the base study and continued with the same dose strength in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
310197|NCT01218971|E5|Reported Event|Placebo to 190mg|Includes participants who received placebo in the base study but switched to Medisorb naltrexone 190mg in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
310198|NCT01218971|E4|Reported Event|380mg to 380mg|Includes participants who received Medisorb naltrexone 380mg in the base study and continued with the same dose strength in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
310199|NCT01218971|E3|Reported Event|Placebo to 380mg|Includes participants who received placebo in the base study but switched to Medisorb naltrexone 380mg in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
310200|NCT01218971|E2|Reported Event|Medisorb Naltrexone 190mg--Combined|Includes all participants who received Medisorb naltrexone 190mg in this extension study. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
310201|NCT01218971|E1|Reported Event|Medisorb Naltrexone 380mg--Combined|Includes all participants who received Medisorb naltrexone 380mg in this extension study. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
310202|NCT01218958|B4|Baseline|Total|Total of all reporting groups
310203|NCT01218958|B3|Baseline|Placebo Groups (Pooled)|Results for the two groups that received placebo were pooled together for reporting purposes.
310204|NCT01218958|B2|Baseline|Medisorb Naltrexone 380 mg|
310205|NCT01218958|B1|Baseline|Medisorb Naltrexone 190 mg|
310206|NCT01218958|P3|Participant Flow|Placebo Groups (Pooled)|Results for the two groups that received placebo were pooled together for reporting purposes.
310207|NCT01218958|P2|Participant Flow|Medisorb Naltrexone 380 mg|
310208|NCT01218958|P1|Participant Flow|Medisorb Naltrexone 190 mg|
310209|NCT01218958|O3|Outcome|Placebo Groups (Pooled)|Results for the two groups that received placebo were pooled together for reporting purposes.
310210|NCT01218958|O2|Outcome|Medisorb Naltrexone 380 mg|
310211|NCT01218958|O1|Outcome|Medisorb Naltrexone 190 mg|
310212|NCT01218958|O3|Outcome|Placebo Groups (Pooled)|Results for the two groups that received placebo were pooled together for reporting purposes.
310213|NCT01218958|O2|Outcome|Medisorb Naltrexone 380 mg|
310214|NCT01218958|O1|Outcome|Medisorb Naltrexone 190 mg|
310215|NCT01218958|E3|Reported Event|Placebo Groups (Pooled)|Results for the two groups that received placebo were pooled together for reporting purposes.
310216|NCT01218958|E2|Reported Event|Medisorb Naltrexone 380 mg|
310217|NCT01218958|E1|Reported Event|Medisorb Naltrexone 190 mg|
310218|NCT01218867|B12|Baseline|Total|Total of all reporting groups
310219|NCT01218867|B11|Baseline|Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310220|NCT01218867|B10|Baseline|Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310221|NCT01218867|B9|Baseline|Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310222|NCT01218867|B8|Baseline|Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310223|NCT01218867|B7|Baseline|Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310224|NCT01218867|B6|Baseline|Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310225|NCT01218867|B5|Baseline|Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310307|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
310308|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
310309|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
310226|NCT01218867|B4|Baseline|Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310227|NCT01218867|B3|Baseline|Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310228|NCT01218867|B2|Baseline|Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310229|NCT01218867|B1|Baseline|Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2 (VEGFR2) Chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310230|NCT01218867|P11|Participant Flow|Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310231|NCT01218867|P10|Participant Flow|Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310232|NCT01218867|P9|Participant Flow|Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310233|NCT01218867|P8|Participant Flow|Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310234|NCT01218867|P7|Participant Flow|Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310235|NCT01218867|P6|Participant Flow|Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310236|NCT01218867|P5|Participant Flow|Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310237|NCT01218867|P4|Participant Flow|Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310238|NCT01218867|P3|Participant Flow|Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310239|NCT01218867|P2|Participant Flow|Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310240|NCT01218867|P1|Participant Flow|Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2 (VEGFR2) chimeric T cell receptor (CAR) cluster of differentiation 8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310241|NCT01218867|O11|Outcome|Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310242|NCT01218867|O10|Outcome|Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310243|NCT01218867|O9|Outcome|Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310244|NCT01218867|O8|Outcome|Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310245|NCT01218867|O7|Outcome|Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310246|NCT01218867|O6|Outcome|Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310247|NCT01218867|O5|Outcome|Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310248|NCT01218867|O4|Outcome|Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310249|NCT01218867|O3|Outcome|Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310432|NCT01218438|O1|Outcome|Intravenous 10%|
310433|NCT01218438|O2|Outcome|Subcutaneous 20%|
310250|NCT01218867|O2|Outcome|Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310251|NCT01218867|O1|Outcome|Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2(VEGFR2) chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310252|NCT01218867|O11|Outcome|Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310253|NCT01218867|O10|Outcome|Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310254|NCT01218867|O9|Outcome|Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310255|NCT01218867|O8|Outcome|Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310256|NCT01218867|O7|Outcome|Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310257|NCT01218867|O6|Outcome|Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310434|NCT01218438|O1|Outcome|Intravenous 10%|
310258|NCT01218867|O5|Outcome|Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310259|NCT01218867|O4|Outcome|Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310260|NCT01218867|O3|Outcome|Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310261|NCT01218867|O2|Outcome|Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310262|NCT01218867|O1|Outcome|Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2(VEGFR2) chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310263|NCT01218867|O11|Outcome|Cohort 11 - 3x10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310264|NCT01218867|O10|Outcome|Cohort 10 - 1x10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310265|NCT01218867|O9|Outcome|Cohort 9 - 3x10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310435|NCT01218438|O2|Outcome|Subcutaneous 20%|
310266|NCT01218867|O8|Outcome|Cohort 8 - 1x10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310267|NCT01218867|O7|Outcome|Cohort 7 - 1x10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310268|NCT01218867|O6|Outcome|Cohort 6 - 3x10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310269|NCT01218867|O5|Outcome|Cohort 5 - 1x10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310270|NCT01218867|O4|Outcome|Cohort 4 - 3x10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310271|NCT01218867|O3|Outcome|Cohort 3 - 1x10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310272|NCT01218867|O2|Outcome|Cohort 2 - 3x10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310273|NCT01218867|O1|Outcome|Cohort 1 - 1x10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2 (VEGFR2) Chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310436|NCT01218438|O1|Outcome|Intravenous 10%|
310274|NCT01218867|E11|Reported Event|Cohort 11 (3x10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310275|NCT01218867|E10|Reported Event|Cohort 10 (1x10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310276|NCT01218867|E9|Reported Event|Cohort 9 (3x10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310277|NCT01218867|E8|Reported Event|Cohort 8 (1x10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310278|NCT01218867|E7|Reported Event|Cohort 7 (1x10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310279|NCT01218867|E6|Reported Event|Cohort 6 (1x10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310280|NCT01218867|E5|Reported Event|Cohort 5 (1x10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310281|NCT01218867|E4|Reported Event|Cohort 4 (3x10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310437|NCT01218438|O2|Outcome|Subcutaneous 20%|
310438|NCT01218438|O1|Outcome|Intravenous 10%|
310282|NCT01218867|E3|Reported Event|Cohort 3 (1x10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310283|NCT01218867|E2|Reported Event|Cohort 2 (3x10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310284|NCT01218867|E1|Reported Event|Cohort 1 (1x10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2 (VEGFR2) chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
310285|NCT01218802|B3|Baseline|Total|Total of all reporting groups
310286|NCT01218802|B2|Baseline|Sugar Pill Placebo|"Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.~Placebo: participants will take a sugar pill daily for 96 weeks"
310287|NCT01218802|B1|Baseline|Rosuvastatin|"Participants will take Rosuvastatin 10 mg. daily for 96 weeks~Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks."
310288|NCT01218802|P2|Participant Flow|Sugar Pill Placebo|"Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.~Placebo: participants will take a sugar pill daily for 96 weeks"
310289|NCT01218802|P1|Participant Flow|Rosuvastatin|"Participants will take Rosuvastatin 10 mg. daily for 96 weeks~Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks."
310290|NCT01218802|O2|Outcome|Sugar Pill Placebo|"Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.~Placebo: participants will take a sugar pill daily for 96 weeks"
310291|NCT01218802|O1|Outcome|Rosuvastatin|"Participants will take Rosuvastatin 10 mg. daily for 96 weeks~Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks."
310292|NCT01218802|O2|Outcome|Sugar Pill Placebo|"Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.~Placebo: participants will take a sugar pill daily for 96 weeks"
310293|NCT01218802|O1|Outcome|Rosuvastatin|"Participants will take Rosuvastatin 10 mg. daily for 96 weeks~Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks."
310294|NCT01218802|E2|Reported Event|Sugar Pill Placebo|"Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.~Placebo: participants will take a sugar pill daily for 96 weeks"
310295|NCT01218802|E1|Reported Event|Rosuvastatin|"Participants will take Rosuvastatin 10 mg. daily for 96 weeks~Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks."
310296|NCT01218646|B5|Baseline|Total|Total of all reporting groups
310297|NCT01218646|B4|Baseline|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
310298|NCT01218646|B3|Baseline|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the received the Licensed 2010-2011 Trivalent Influenza Vaccine
310299|NCT01218646|B2|Baseline|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
310300|NCT01218646|B1|Baseline|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
310301|NCT01218646|P4|Participant Flow|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine.
310302|NCT01218646|P3|Participant Flow|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
310303|NCT01218646|P2|Participant Flow|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
310304|NCT01218646|P1|Participant Flow|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
310305|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
310306|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
310439|NCT01218438|O2|Outcome|SUBCUTANEOUS 20%|
310310|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
310311|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
310312|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
310313|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
310314|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
310315|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
310316|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
310317|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
310318|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
310319|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
310320|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
310321|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
310322|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
310323|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
310324|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
310325|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
310326|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
310327|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
310328|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
310329|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
310330|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
310331|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
310332|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
310333|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
310334|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
310335|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
310336|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
310337|NCT01218646|E4|Reported Event|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
310338|NCT01218646|E3|Reported Event|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the received the Licensed 2010-2011 Trivalent Influenza Vaccine
310339|NCT01218646|E2|Reported Event|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
310340|NCT01218646|E1|Reported Event|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
310341|NCT01218594|B1|Baseline|Endostar Plus CCRT|Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60~66 Gy.
310342|NCT01218594|P1|Participant Flow|Endostar Plus CCRT|Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60~66 Gy.
310343|NCT01218594|O1|Outcome|Endostar Plus CCRT|Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60~66 Gy.
310344|NCT01218594|E1|Reported Event|Endostar Plus CCRT|Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60~66 Gy.
310345|NCT01218477|B5|Baseline|Total|Total of all reporting groups
310440|NCT01218438|O1|Outcome|INTRAVENOUS 10%|
310441|NCT01218438|O2|Outcome|SUBCUTANEOUS 20%|
310442|NCT01218438|O1|Outcome|INTRAVENOUS 10%|
310346|NCT01218477|B4|Baseline|Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD|Participants received BMS-833923, 200 mg twice daily (BID) for 7 days then once daily (QD) plus dasatinib, 100 /140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
310347|NCT01218477|B3|Baseline|Dasatinib, 100/140 mg QD + BMS-833923, 100 mg BID/QD|Participants received BMS-833923, 100 mg twice daily (BID) for 7 days then once daily (QD) + dasatinib, 100/140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
310348|NCT01218477|B2|Baseline|Dasatinib, 100/140 mg QD + BMS-833923, 50 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), plus BMS-833923, 50 mg, QD), depending on cohort cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
310349|NCT01218477|B1|Baseline|Dasatinib, 100/140 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase)
310350|NCT01218477|P4|Participant Flow|Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD|Participants received BMS-833923, 200 mg twice daily (BID) for 7 days then 200 mg once daily (QD) plus dasatinib, 100 /140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
310351|NCT01218477|P3|Participant Flow|Dasatinib, 100/140 mg QD + BMS-833923, 100 mg BID/QD|Participants received BMS-833923, 100 mg twice daily (BID), for 7 days then once daily (QD) + dasatinib, 100/140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
310352|NCT01218477|P2|Participant Flow|Dasatinib, 100/140 mg QD + BMS-833923, 50 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase) plus BMS-833923, 50 mg QD
310353|NCT01218477|P1|Participant Flow|Dasatinib, 100/140 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase)
310354|NCT01218477|O4|Outcome|Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD|Participants received BMS-833923, 200 mg twice daily (BID) for 7 days, then once daily (QD), plus dasatinib, 100 /140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
310355|NCT01218477|O3|Outcome|Dasatinib, 100/140 mg QD + BMS-833923, 100 mg BID|Participants received BMS-833923, 100 mg twice daily (BID), for 7 days, followed by dasatinib, 100/140 mg once daily (QD)
310356|NCT01218477|O2|Outcome|Dasatinib, 100/140 mg QD + BMS-833923, 50 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase) plus BMS-833923, 50 mg, QD
310357|NCT01218477|O1|Outcome|Dasatinib, 100/140 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase)
310358|NCT01218477|O4|Outcome|Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD|Participants received BMS-833923, 200 mg twice daily (BID) for 7 days, then once daily (QD), plus dasatinib, 100 /140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
310359|NCT01218477|O3|Outcome|Dasatinib, 100/140 mg QD + BMS-833923, 100 mg BID/QD|Participants received BMS-833923, 100 mg twice daily (BID) for 7 days then once daily (QD) + dasatinib, 100/140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
310360|NCT01218477|O2|Outcome|Dasatinib, 100/140 mg QD + BMS-833923, 50 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase) plus BMS-833923, 50 mg, QD
310361|NCT01218477|O1|Outcome|Dasatinib, 100/140 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase)
310362|NCT01218477|O1|Outcome|Dasatinib, 100/140 mg QD, Plus BMS-833923, 50-200 BID/QD|Participants received BMS-833923 + dasatinib at 1 of 4 dosing levels: Dasatinib, 100 mg/140 mg QD, depending on cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase); BMS-833923, 50 mg once daily (QD) + dasatinib, 100 mg/140 mg QD; BMS-833923, 100 mg twice daily (BID) for 7 days, then 100 mg QD + dasatinib 100 mg/140 mg QD; or BMS-833923, 200 mg BID for 7 days, then 200 mg QD + dasatinib 100 mg/140 mg QD
310363|NCT01218477|O1|Outcome|Dasatinib, 100/140 mg QD, Plus BMS-833923, 50-200 BID/QD|Participants received BMS-833923 + dasatinib at 1 of 4 dosing levels: Dasatinib, 100 mg/140 mg QD, depending on cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase); BMS-833923, 50 mg once daily (QD) + dasatinib, 100 mg/140 mg QD; BMS-833923, 100 mg twice daily (BID) for 7 days, then 100 mg QD + dasatinib 100 mg/140 mg QD; or BMS-833923, 200 mg BID for 7 days, then 200 mg QD + dasatinib 100 mg/140 mg QD
310364|NCT01218477|O1|Outcome|Dasatinib, 100/140 mg QD, Plus BMS-833923, 50-200 BID/QD|Participants received BMS-833923 + dasatinib at 1 of 4 dosing levels: Dasatinib, 100 mg/140 mg QD, depending on cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase); BMS-833923, 50 mg once daily (QD) + dasatinib, 100 mg/140 mg QD; BMS-833923, 100 mg twice daily (BID) for 7 days, then 100 mg QD + dasatinib 100 mg/140 mg QD; or BMS-833923, 200 mg BID for 7 days, then 200 mg QD + dasatinib 100 mg/140 mg QD
310365|NCT01218477|E4|Reported Event|Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD|Participants received BMS-833923, 200 mg twice daily (BID) for 7 days then 200 mg once daily (QD) plus dasatinib, 100 /140 mg QD), depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
310366|NCT01218477|E3|Reported Event|Dasatanib, 100/140 mg QD + BMS-833923, 100 mg BID/QD|Participants received BMS-833923, 100 mg twice daily (BID) for 7 days then once daily (QD) + dasatanib, 100/140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
310367|NCT01218477|E2|Reported Event|Dasatanib, 100/140 mg QD + BMS-833923, 50 mg QD|Participants received dasatanib, 100/140 mg once daily (QD), as oral tablets plus BMS-833923, 50 mg, QD (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
310368|NCT01218477|E1|Reported Event|Dasatinib, 100/140 mg QD|Participants received dasatinib, 100/140 mg once daily (QD) (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
310443|NCT01218438|O2|Outcome|SUBCUTANEOUS 20%|
310369|NCT01218438|B1|Baseline|Study Epochs 1-4|"EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.~EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
310370|NCT01218438|P1|Participant Flow|Study Participants|"EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.~EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
310371|NCT01218438|O6|Outcome|Change End of Epoch 1 to End of Epoch 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
310372|NCT01218438|O5|Outcome|Change End of Epoch 1 to End of Epoch 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
310373|NCT01218438|O4|Outcome|End of Epoch 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
310374|NCT01218438|O3|Outcome|End of Epoch 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
310375|NCT01218438|O2|Outcome|End of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
310376|NCT01218438|O1|Outcome|Start of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
310377|NCT01218438|O6|Outcome|Change End of Epoch 1 to End of Epoch 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
310378|NCT01218438|O5|Outcome|Change End of Epoch 1 to End of Epoch 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
310379|NCT01218438|O4|Outcome|End of Epoch 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
310380|NCT01218438|O3|Outcome|End of Epoch 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
310381|NCT01218438|O2|Outcome|End of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
310382|NCT01218438|O1|Outcome|Start of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
310383|NCT01218438|O6|Outcome|Change End of Epoch 1 to End of Epoch 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
310384|NCT01218438|O5|Outcome|Change End of Epoch 1 to End of Epoch 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
310385|NCT01218438|O4|Outcome|End of Epoch 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
310386|NCT01218438|O3|Outcome|End of Epoch 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
310387|NCT01218438|O2|Outcome|End of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
310388|NCT01218438|O1|Outcome|Start of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
310389|NCT01218438|O6|Outcome|Change End of Epoch 1 to End of Epoch 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
310444|NCT01218438|O1|Outcome|INTRAVENOUS 10%|
310445|NCT01218438|O1|Outcome|Correction Factor|
310630|NCT01218204|O2|Outcome|Atorvastatin 10 mg + GSK1292263 300 mg|Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.
310390|NCT01218438|O5|Outcome|Change End of Epoch 1 to End of Epoch 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
310391|NCT01218438|O4|Outcome|End of Epoch 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
310392|NCT01218438|O3|Outcome|End of Epoch 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
310393|NCT01218438|O2|Outcome|End of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
310394|NCT01218438|O1|Outcome|Start of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
310395|NCT01218438|O6|Outcome|CHANGE END EPOCH 1 TO END EPOCH 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
310396|NCT01218438|O5|Outcome|CHANGE END EPOCH 1 TO END EPOCH 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
310397|NCT01218438|O4|Outcome|END OF STUDY EPOCH 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
310398|NCT01218438|O3|Outcome|END OF STUDY EPOCH 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
310399|NCT01218438|O2|Outcome|END OF STUDY EPOCH 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
310400|NCT01218438|O1|Outcome|START OF STUDY EPOCH 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
310401|NCT01218438|O6|Outcome|Change End of Epoch 1 to End of Epoch 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
310402|NCT01218438|O5|Outcome|Change End of Epoch 1 to End of Epoch 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
310403|NCT01218438|O4|Outcome|End of Epoch 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
310404|NCT01218438|O3|Outcome|End of Epoch 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
310405|NCT01218438|O2|Outcome|End of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
310406|NCT01218438|O1|Outcome|Start of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
310407|NCT01218438|O6|Outcome|Change End Epoch 1 to End Epoch 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
310408|NCT01218438|O5|Outcome|Change End Epoch 1 to End Epoch 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
310409|NCT01218438|O4|Outcome|End of Study Epoch 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
310410|NCT01218438|O3|Outcome|End of Study Epoch 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
310411|NCT01218438|O2|Outcome|End of Study Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
310412|NCT01218438|O1|Outcome|Start of Study Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
310413|NCT01218438|O2|Outcome|Subcutaneous 20%|
310414|NCT01218438|O1|Outcome|Intravenous 10%|
310415|NCT01218438|O2|Outcome|Subcutaneous 20%|
310416|NCT01218438|O1|Outcome|Intravenous 10%|
310417|NCT01218438|O2|Outcome|Subcutaneous 20%|
310418|NCT01218438|O1|Outcome|Intravenous 10%|
310419|NCT01218438|O2|Outcome|Subcutaneous 20%|
310420|NCT01218438|O1|Outcome|Intravenous 10%|
310421|NCT01218438|O2|Outcome|Subcutaneous 20%|
310422|NCT01218438|O1|Outcome|Intravenous 10%|
310423|NCT01218438|O2|Outcome|Subcutaneous 20%|
310424|NCT01218438|O1|Outcome|Intravenous 10%|
310425|NCT01218438|O2|Outcome|Subcutaneous 20%|
310426|NCT01218438|O1|Outcome|Intravenous 10%|
310427|NCT01218438|O2|Outcome|Subcutaneous 20%|
310428|NCT01218438|O1|Outcome|Intravenous 10%|
310429|NCT01218438|O2|Outcome|Subcutaneous 20%|
310430|NCT01218438|O1|Outcome|Intravenous 10%|
310431|NCT01218438|O2|Outcome|Subcutaneous 20%|
310446|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20%, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
310447|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20%, 145% of IGIV 10%|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
310448|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
310449|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
310450|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
310451|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
310452|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
310453|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
310454|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
310455|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20%, 145% of IGIV 10%|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
310456|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
310457|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
310458|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20%, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
310459|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20%, 145% of IGIV 10%|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
310460|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
310461|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 WeeksOverall Study Arm|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
310462|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
310463|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
310464|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
310465|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
310622|NCT01218204|O2|Outcome|Atorvastatin 10 mg + GSK1292263 300 mg|Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.
310466|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
310467|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
310468|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
310469|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
310470|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
310471|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
310472|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
310473|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
310474|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
310475|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
310476|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
310477|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
310478|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
310479|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
310480|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Week|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
310481|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
310482|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
310483|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
310484|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
310485|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
310623|NCT01218204|O1|Outcome|Atorvastatin 10 mg + GSK1292263 100 mg|Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.
310486|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
310487|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
310488|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
310489|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
310490|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously (IGSC)
310491|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|"Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~Immune globulin administered subcutaneously (IGSC)"
310492|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|"Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study.~Immune globulin administered intravenously (IGIV)"
310493|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|"Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study.~Immune globulin administered intravenously (IGIV)"
310494|NCT01218438|O1|Outcome|Study Epochs 1-4|"Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.~Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
310495|NCT01218438|O1|Outcome|Overall Study Arm|
310496|NCT01218438|O1|Outcome|Overall Study Arm|
310497|NCT01218438|O5|Outcome|SC 20% Individualized 1 Week|
310498|NCT01218438|O4|Outcome|SC 20% Adjusted 1 Week|
310499|NCT01218438|O3|Outcome|SC 20% 145% IV 1 Week|
310500|NCT01218438|O2|Outcome|IV 10% 4 Weeks|
310501|NCT01218438|O1|Outcome|IV 10% 3 Weeks|"Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.~Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
310502|NCT01218438|O1|Outcome|Study Epochs 1-4|"Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.~Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
310503|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
310504|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
310631|NCT01218204|O1|Outcome|Atorvastatin 10 mg + GSK1292263 100 mg|Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.
310505|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
310506|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
310507|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
310508|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
310509|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
310510|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
310511|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
310512|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
310513|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
310514|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
310515|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
310516|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
310517|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
310674|NCT01218204|O3|Outcome|Atorvastatin 10 mg + GSK1292263 800 mg|Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
311530|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
310518|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
310519|NCT01218438|O1|Outcome|Study Participants|
310520|NCT01218438|E2|Reported Event|Study Epochs 2-4: Subcutaneous 20% Treatment|
310521|NCT01218438|E1|Reported Event|Study Epoch 1: Intravenous 10% Treatment|
310522|NCT01218399|B3|Baseline|Total|Total of all reporting groups
310523|NCT01218399|B2|Baseline|Budesonide|"control of budesonide alone~Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide"
310524|NCT01218399|B1|Baseline|Symbicort|"combination of budesonide and formoterol~Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide"
310525|NCT01218399|P2|Participant Flow|Budesonide|"Control of budesonide alone~Pulmicort Flexhaler will be given as per product insert (2 puffs twice daily of 160 mcg)"
310526|NCT01218399|P1|Participant Flow|Symbicort|"Combination of budesonide and formoterol~Symbicort will be given as per product insert (2 puffs twice daily of 160/4.5 Budesonide/formoterol)"
310527|NCT01218399|O2|Outcome|Budesonide|"control of budesonide alone~Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide"
310528|NCT01218399|O1|Outcome|Symbicort|"combination of budesonide and formoterol~Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide"
310529|NCT01218399|O2|Outcome|Budesonide|"control of budesonide alone~Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide"
310530|NCT01218399|O1|Outcome|Symbicort|"combination of budesonide and formoterol~Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide"
310531|NCT01218399|E2|Reported Event|Budesonide|"control of budesonide alone~Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide"
310532|NCT01218399|E1|Reported Event|Symbicort|"combination of budesonide and formoterol~Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide"
310533|NCT01218308|B3|Baseline|Total|Total of all reporting groups
310534|NCT01218308|B2|Baseline|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310535|NCT01218308|B1|Baseline|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310536|NCT01218308|P2|Participant Flow|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310537|NCT01218308|P1|Participant Flow|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310538|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310539|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310540|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310541|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310542|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310543|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310544|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310545|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310546|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
311445|NCT01217307|O1|Outcome|Metformin|"metformin 500mg twice daily during 4 months~Metformin: Metformin 500mg twice daily during 4 months"
310547|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310548|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310549|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310550|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310551|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310552|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310553|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310554|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310555|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310556|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310557|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310558|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310559|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310560|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310561|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310562|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310563|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310564|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310565|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310566|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310624|NCT01218204|O1|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants on 80 mg atorvastatin (either for >=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.
310567|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310568|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310569|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310570|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310571|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310572|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310573|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310574|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310575|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310576|NCT01218308|E2|Reported Event|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310577|NCT01218308|E1|Reported Event|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
310578|NCT01218243|B3|Baseline|Total|Total of all reporting groups
310579|NCT01218243|B2|Baseline|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
310580|NCT01218243|B1|Baseline|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
310581|NCT01218243|P2|Participant Flow|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
310582|NCT01218243|P1|Participant Flow|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
310625|NCT01218204|O7|Outcome|Atorvastatin 80 mg + Placebo|Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310626|NCT01218204|O6|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310627|NCT01218204|O5|Outcome|Atorvastatin 10 mg + Ezetimibe 10 mg|Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.
310583|NCT01218243|O2|Outcome|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
310584|NCT01218243|O1|Outcome|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
310585|NCT01218243|O2|Outcome|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
310586|NCT01218243|O1|Outcome|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
310587|NCT01218243|O2|Outcome|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
310588|NCT01218243|O1|Outcome|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
310589|NCT01218243|O2|Outcome|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
310590|NCT01218243|O1|Outcome|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
310591|NCT01218243|O2|Outcome|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
310592|NCT01218243|O1|Outcome|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
310628|NCT01218204|O4|Outcome|Atorvastatin 10 mg + Placebo|Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310629|NCT01218204|O3|Outcome|Atorvastatin 10 mg + GSK1292263 800 mg|Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
311531|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
310593|NCT01218243|E2|Reported Event|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
310594|NCT01218243|E1|Reported Event|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
310595|NCT01218204|B3|Baseline|Total|Total of all reporting groups
310596|NCT01218204|B2|Baseline|Part B|Part B included Washout phase (Participants were washed off their prior lipid-lowering therapy for 4 weeks), Run-in phase (Eligible participants were randomized to receive 10 mg open-labeled atorvastatin or 80 mg open-labeled atorvastatin for a 4-week stabilization run-in period) and Treatment phase (Randomized participants after washout received monotherpy (100 mg, 300 mg or 800 mg of GSK1292263 or placebo) for 2 weeks. Participants in the 10mg atorvastatin run-in group received GSK1292263, 300 mg QD GSK1292263, 800 mg QD GSK1292263, placebo for GSK1292263 or 10 mg open-label ezetimibe for 2 weeks. Participants in the 80 mg atorvastatin run-in group received 800 mg QD GSK1292263 and placebo for GSK1292263 for 2 weeks)
310597|NCT01218204|B1|Baseline|Part A|Four participants on 80 mg atorvastatin [either for >=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg], received GSK1292263 800 mg for 2 weeks, and 2 participants not on lipid-modifying treatment received GSK1282263 800 mg alone for 2 weeks.
310598|NCT01218204|P4|Participant Flow|Part B Pooled Treatment Arm|In this pooled arm, after washout, randomized participants were stratified into 11 arms to receive either atorvastatin 10 mg along with 100 mg or 300 mg or 800 mg of GSK129226 or placebo or ezetimibe 10 mg once daily for 2 weeks; or atorvastatin 80 mg along with 800 mg of GSK129226 or placebo once daily for 2 weeks; or monotherapy (100 mg, 300 mg or 800 mg of GSK1292263 or placebo) once daily for 2 weeks.
310599|NCT01218204|P3|Participant Flow|Part B Run-in|Eligible participants were randomized to receive 10 mg open-labeled atorvastatin or 80 mg open-labeled atorvastatin for a 4-week stabilization run-in period.
310600|NCT01218204|P2|Participant Flow|Part B Washout|Participants were washed off their prior lipid-lowering therapy for 4 weeks.
310601|NCT01218204|P1|Participant Flow|Part A|Four participants on 80 milligrams (mg) atorvastatin [either for >=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40mg], received GSK1292263 800 mg for 2 weeks, and 2 participants not on lipid-modifying treatment received GSK1282263 800 mg alone for 2 weeks.
310602|NCT01218204|O7|Outcome|Atorvastatin 80 mg + Placebo|Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310603|NCT01218204|O6|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310604|NCT01218204|O5|Outcome|Atorvastatin 10 mg + Ezetimibe 10 mg|Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.
310605|NCT01218204|O4|Outcome|Atorvastatin 10 mg + Placebo|Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310606|NCT01218204|O3|Outcome|Atorvastatin 10 mg + GSK1292263 800 mg|Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310607|NCT01218204|O2|Outcome|Atorvastatin 10 mg + GSK1292263 300 mg|Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.
310608|NCT01218204|O1|Outcome|Atorvastatin 10 mg + GSK1292263 100 mg|Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.
310609|NCT01218204|O7|Outcome|Atorvastatin 80 mg + Placebo|Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310610|NCT01218204|O6|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310611|NCT01218204|O5|Outcome|Atorvastatin 10 mg + Ezetimibe 10 mg|Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.
310612|NCT01218204|O4|Outcome|Atorvastatin 10 mg + Placebo|Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310613|NCT01218204|O3|Outcome|Atorvastatin 10 mg + GSK1292263 800 mg|Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310614|NCT01218204|O2|Outcome|Atorvastatin 10 mg + GSK1292263 300 mg|Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.
310615|NCT01218204|O1|Outcome|Atorvastatin 10 mg + GSK1292263 100 mg|Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.
310616|NCT01218204|O1|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants on 80 mg atorvastatin (either for >=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.
310617|NCT01218204|O7|Outcome|Atorvastatin 80 mg + Placebo|Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310618|NCT01218204|O6|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310619|NCT01218204|O5|Outcome|Atorvastatin 10 mg + Ezetimibe 10 mg|Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.
310620|NCT01218204|O4|Outcome|Atorvastatin 10 mg + Placebo|Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310621|NCT01218204|O3|Outcome|Atorvastatin 10 mg + GSK1292263 800 mg|Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310632|NCT01218204|O1|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants on 80 mg atorvastatin (either for >=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.
310633|NCT01218204|O11|Outcome|Placebo|After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks.
310634|NCT01218204|O10|Outcome|GSK1292263 800 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.
310635|NCT01218204|O9|Outcome|GSK1292263 300 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.
310636|NCT01218204|O8|Outcome|GSK1292263 100 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.
310637|NCT01218204|O7|Outcome|Atorvastatin 80 mg + Placebo|Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310638|NCT01218204|O6|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310639|NCT01218204|O5|Outcome|Atorvastatin 10 mg + Ezetimibe 10 mg|Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.
310640|NCT01218204|O4|Outcome|Atorvastatin 10 mg + Placebo|Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310641|NCT01218204|O3|Outcome|Atorvastatin 10 mg + GSK1292263 800 mg|Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310642|NCT01218204|O2|Outcome|Atorvastatin 10 mg + GSK1292263 300 mg|Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.
310643|NCT01218204|O1|Outcome|Atorvastatin 10 mg + GSK1292263 100 mg|Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.
310644|NCT01218204|O11|Outcome|Placebo|After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks.
310645|NCT01218204|O10|Outcome|GSK1292263 800 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.
310646|NCT01218204|O9|Outcome|GSK1292263 300 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.
310647|NCT01218204|O8|Outcome|GSK1292263 100 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.
310648|NCT01218204|O7|Outcome|Atorvastatin 80 mg + Placebo|Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310649|NCT01218204|O6|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310650|NCT01218204|O5|Outcome|Atorvastatin 10 mg + Ezetimibe 10 mg|Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.
310651|NCT01218204|O4|Outcome|Atorvastatin 10 mg + Placebo|Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310652|NCT01218204|O3|Outcome|Atorvastatin 10 mg + GSK1292263 800 mg|Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310653|NCT01218204|O2|Outcome|Atorvastatin 10 mg + GSK1292263 300 mg|Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.
310654|NCT01218204|O1|Outcome|Atorvastatin 10 mg + GSK1292263 100 mg|Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.
310655|NCT01218204|O11|Outcome|Placebo|After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks.
310656|NCT01218204|O10|Outcome|GSK1292263 800 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.
310657|NCT01218204|O9|Outcome|GSK1292263 300 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.
310658|NCT01218204|O8|Outcome|GSK1292263 100 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.
310659|NCT01218204|O7|Outcome|Atorvastatin 80 mg + Placebo|Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310660|NCT01218204|O6|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310661|NCT01218204|O5|Outcome|Atorvastatin 10 mg + Ezetimibe 10 mg|Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.
310662|NCT01218204|O4|Outcome|Atorvastatin 10 mg + Placebo|Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310663|NCT01218204|O3|Outcome|Atorvastatin 10 mg + GSK1292263 800 mg|Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310664|NCT01218204|O2|Outcome|Atorvastatin 10 mg + GSK1292263 300 mg|Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.
310665|NCT01218204|O1|Outcome|Atorvastatin 10 mg + GSK1292263 100 mg|Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.
310666|NCT01218204|O11|Outcome|Placebo|After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks.
310667|NCT01218204|O10|Outcome|GSK1292263 800 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.
310668|NCT01218204|O9|Outcome|GSK1292263 300 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.
310669|NCT01218204|O8|Outcome|GSK1292263 100 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.
310670|NCT01218204|O7|Outcome|Atorvastatin 80 mg + Placebo|Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310671|NCT01218204|O6|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310672|NCT01218204|O5|Outcome|Atorvastatin 10 mg + Ezetimibe 10 mg|Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.
310673|NCT01218204|O4|Outcome|Atorvastatin 10 mg + Placebo|Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310675|NCT01218204|O2|Outcome|Atorvastatin 10 mg + GSK1292263 300 mg|Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.
310676|NCT01218204|O1|Outcome|Atorvastatin 10 mg + GSK1292263 100 mg|Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.
310677|NCT01218204|O11|Outcome|Placebo|After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks.
310678|NCT01218204|O10|Outcome|GSK1292263 800 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.
310679|NCT01218204|O9|Outcome|GSK1292263 300 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.
310680|NCT01218204|O8|Outcome|GSK1292263 100 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.
310681|NCT01218204|O7|Outcome|Atorvastatin 80 mg + Placebo|Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310682|NCT01218204|O6|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310683|NCT01218204|O5|Outcome|Atorvastatin 10 mg + Ezetimibe 10 mg|Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.
310684|NCT01218204|O4|Outcome|Atorvastatin 10 mg + Placebo|Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310685|NCT01218204|O3|Outcome|Atorvastatin 10 mg + GSK1292263 800 mg|Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310686|NCT01218204|O2|Outcome|Atorvastatin 10 mg + GSK1292263 300 mg|Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.
310687|NCT01218204|O1|Outcome|Atorvastatin 10 mg + GSK1292263 100 mg|Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.
310688|NCT01218204|O7|Outcome|Atorvastatin 80 mg + Placebo|Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310689|NCT01218204|O6|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310690|NCT01218204|O5|Outcome|Atorvastatin 10 mg + Ezetimibe 10 mg|Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.
310691|NCT01218204|O4|Outcome|Atorvastatin 10 mg + Placebo|Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310692|NCT01218204|O3|Outcome|Atorvastatin 10 mg + GSK1292263 800 mg|Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310693|NCT01218204|O2|Outcome|Atorvastatin 10 mg + GSK1292263 300 mg|Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.
310694|NCT01218204|O1|Outcome|Atorvastatin 10 mg + GSK1292263 100 mg|Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.
310695|NCT01218204|O7|Outcome|Atorvastatin 80 mg + Placebo|Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310696|NCT01218204|O6|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310697|NCT01218204|O5|Outcome|Atorvastatin 10 mg + Ezetimibe 10 mg|Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.
310698|NCT01218204|O4|Outcome|Atorvastatin 10 mg + Placebo|Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310699|NCT01218204|O3|Outcome|Atorvastatin 10 mg + GSK1292263 800 mg|Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310700|NCT01218204|O2|Outcome|Atorvastatin 10 mg + GSK1292263 300 mg|Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.
310701|NCT01218204|O1|Outcome|Atorvastatin 10 mg + GSK1292263 100 mg|Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.
310702|NCT01218204|O1|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants on 80 mg atorvastatin (either for >=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.
310703|NCT01218204|O7|Outcome|Atorvastatin 80 mg + Placebo|Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310704|NCT01218204|O6|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310705|NCT01218204|O5|Outcome|Atorvastatin 10 mg + Ezetimibe 10 mg|Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.
310706|NCT01218204|O4|Outcome|Atorvastatin 10 mg + Placebo|Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310707|NCT01218204|O3|Outcome|Atorvastatin 10 mg + GSK1292263 800 mg|Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310708|NCT01218204|O2|Outcome|Atorvastatin 10 mg + GSK1292263 300 mg|Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.
310709|NCT01218204|O1|Outcome|Atorvastatin 10 mg + GSK1292263 100 mg|Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.
310710|NCT01218204|O1|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants on 80 mg atorvastatin (either for >=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.
310711|NCT01218204|O7|Outcome|Atorvastatin 80 mg + Placebo|Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310712|NCT01218204|O6|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310713|NCT01218204|O5|Outcome|Atorvastatin 10 mg + Ezetimibe 10 mg|Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.
310714|NCT01218204|O4|Outcome|Atorvastatin 10 mg + Placebo|Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310715|NCT01218204|O3|Outcome|Atorvastatin 10 mg + GSK1292263 800 mg|Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310716|NCT01218204|O2|Outcome|Atorvastatin 10 mg + GSK1292263 300 mg|Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.
310717|NCT01218204|O1|Outcome|Atorvastatin 10 mg + GSK1292263 100 mg|Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.
310718|NCT01218204|O1|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants on 80 mg atorvastatin (either for >=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.
310719|NCT01218204|O7|Outcome|GSK1292263 800 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.
310720|NCT01218204|O6|Outcome|GSK1292263 300 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.
310721|NCT01218204|O5|Outcome|GSK1292263 100 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.
310722|NCT01218204|O4|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310723|NCT01218204|O3|Outcome|Atorvastatin 10 mg + GSK1292263 800 mg|Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310724|NCT01218204|O2|Outcome|Atorvastatin 10 mg + GSK1292263 300 mg|Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.
310725|NCT01218204|O1|Outcome|Atorvastatin 10 mg + GSK1292263 100 mg|Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.
310726|NCT01218204|O7|Outcome|GSK1292263 800 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.
310727|NCT01218204|O6|Outcome|GSK1292263 300 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.
310728|NCT01218204|O5|Outcome|GSK1292263 100 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.
310729|NCT01218204|O4|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310730|NCT01218204|O3|Outcome|Atorvastatin 10 mg + GSK1292263 800 mg|Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310731|NCT01218204|O2|Outcome|Atorvastatin 10 mg + GSK1292263 300 mg|Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.
310732|NCT01218204|O1|Outcome|Atorvastatin 10 mg + GSK1292263 100 mg|Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.
310733|NCT01218204|O2|Outcome|GSK1292263 800 mg|Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.
310734|NCT01218204|O1|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants on 80 mg atorvastatin (either for >=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.
310735|NCT01218204|O7|Outcome|GSK1292263 800 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.
310736|NCT01218204|O6|Outcome|GSK1292263 300 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.
310737|NCT01218204|O5|Outcome|GSK1292263 100 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.
310738|NCT01218204|O4|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310739|NCT01218204|O3|Outcome|Atorvastatin 10 mg + GSK1292263 800 mg|Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310740|NCT01218204|O2|Outcome|Atorvastatin 10 mg + GSK1292263 300 mg|Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.
310741|NCT01218204|O1|Outcome|Atorvastatin 10 mg + GSK1292263 100 mg|Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.
310742|NCT01218204|O7|Outcome|GSK1292263 800 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.
310743|NCT01218204|O6|Outcome|GSK1292263 300 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.
310744|NCT01218204|O5|Outcome|GSK1292263 100 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.
310745|NCT01218204|O4|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310746|NCT01218204|O3|Outcome|Atorvastatin 10 mg + GSK1292263 800 mg|Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310747|NCT01218204|O2|Outcome|Atorvastatin 10 mg + GSK1292263 300 mg|Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.
310748|NCT01218204|O1|Outcome|Atorvastatin 10 mg + GSK1292263 100 mg|Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.
310749|NCT01218204|O2|Outcome|GSK1292263 800 mg|Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.
310750|NCT01218204|O1|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants on 80 mg atorvastatin (either for >=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.
310751|NCT01218204|O2|Outcome|GSK1292263 800 mg|Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.
310752|NCT01218204|O1|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants on 80 mg atorvastatin (either for >=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.
310753|NCT01218204|O7|Outcome|GSK1292263 800 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.
310754|NCT01218204|O6|Outcome|GSK1292263 300 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.
310755|NCT01218204|O5|Outcome|GSK1292263 100 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.
310756|NCT01218204|O4|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310757|NCT01218204|O3|Outcome|Atorvastatin 10 mg + GSK1292263 800 mg|Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310758|NCT01218204|O2|Outcome|Atorvastatin 10 mg + GSK1292263 300 mg|Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.
310759|NCT01218204|O1|Outcome|Atorvastatin 10 mg + GSK1292263 100 mg|Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.
310760|NCT01218204|O2|Outcome|GSK1292263 800 mg|Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.
310761|NCT01218204|O1|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants on 80 mg atorvastatin (either for >=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.
310762|NCT01218204|O11|Outcome|Placebo|After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks.
310763|NCT01218204|O10|Outcome|GSK1292263 800 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.
310764|NCT01218204|O9|Outcome|GSK1292263 300 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.
310765|NCT01218204|O8|Outcome|GSK1292263 100 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.
310766|NCT01218204|O7|Outcome|Atorvastatin 80 mg + Placebo|Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310767|NCT01218204|O6|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310768|NCT01218204|O5|Outcome|Atorvastatin 10 mg + Ezetimibe 10 mg|Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.
310769|NCT01218204|O4|Outcome|Atorvastatin 10 mg + Placebo|Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310770|NCT01218204|O3|Outcome|Atorvastatin 10 mg + GSK1292263 800 mg|Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310771|NCT01218204|O2|Outcome|Atorvastatin 10 mg + GSK1292263 300 mg|Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.
310772|NCT01218204|O1|Outcome|Atorvastatin 10 mg + GSK1292263 100 mg|Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.
310773|NCT01218204|O2|Outcome|Atorvastatin 80 mg|After washout participants received atorvastatin 80 mg for a 4-week stabilization Run-in Period.
310774|NCT01218204|O1|Outcome|Atorvastatin 10 mg|After washout participants received atorvastatin 10 mg for a 4-week stabilization Run-in Period.
310775|NCT01218204|O1|Outcome|Washout|During the 4 weeks washout period, participants were asked to stop their lipid-modifying drugs.
310776|NCT01218204|O2|Outcome|GSK1292263 800 mg|Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.
310777|NCT01218204|O1|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants on 80 mg atorvastatin (either for >=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.
310778|NCT01218204|O11|Outcome|Placebo|After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks.
310779|NCT01218204|O10|Outcome|GSK1292263 800 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.
310780|NCT01218204|O9|Outcome|GSK1292263 300 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.
310781|NCT01218204|O8|Outcome|GSK1292263 100 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.
310782|NCT01218204|O7|Outcome|Atorvastatin 80 mg + Placebo|Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310783|NCT01218204|O6|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310784|NCT01218204|O5|Outcome|Atorvastatin 10 mg + Ezetimibe 10 mg|Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.
310785|NCT01218204|O4|Outcome|Atorvastatin 10 mg + Placebo|Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310786|NCT01218204|O3|Outcome|Atorvastatin 10 mg + GSK1292263 800 mg|Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310787|NCT01218204|O2|Outcome|Atorvastatin 10 mg + GSK1292263 300 mg|Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.
310788|NCT01218204|O1|Outcome|Atorvastatin 10 mg + GSK1292263 100 mg|Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.
310789|NCT01218204|O2|Outcome|Atorvastatin 80 mg|After washout participants received atorvastatin 80 mg for a 4-week stabilization Run-in Period.
310790|NCT01218204|O1|Outcome|Atorvastatin 10 mg|After washout participants received atorvastatin 10 mg for a 4-week stabilization Run-in Period.
310791|NCT01218204|O1|Outcome|Washout|During the 4 weeks washout period, participants were asked to stop their lipid-modifying drugs.
310792|NCT01218204|O2|Outcome|GSK1292263 800 mg|Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.
310793|NCT01218204|O1|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants on 80 mg atorvastatin (either for >=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.
310794|NCT01218204|O11|Outcome|Placebo|After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks.
311532|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
310795|NCT01218204|O10|Outcome|GSK1292263 800 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.
310796|NCT01218204|O9|Outcome|GSK1292263 300 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.
310797|NCT01218204|O8|Outcome|GSK1292263 100 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.
310798|NCT01218204|O7|Outcome|Atorvastatin 80 mg + Placebo|Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310799|NCT01218204|O6|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310800|NCT01218204|O5|Outcome|Atorvastatin 10 mg + Ezetimibe 10 mg|Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.
310801|NCT01218204|O4|Outcome|Atorvastatin 10 mg + Placebo|Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310802|NCT01218204|O3|Outcome|Atorvastatin 10 mg + GSK1292263 800 mg|Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310803|NCT01218204|O2|Outcome|Atorvastatin 10 mg + GSK1292263 300 mg|Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.
310804|NCT01218204|O1|Outcome|Atorvastatin 10 mg + GSK1292263 100 mg|Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.
310805|NCT01218204|O2|Outcome|Atorvastatin 80 mg|After washout participants received atorvastatin 80 mg for a 4-week stabilization Run-in Period.
310806|NCT01218204|O1|Outcome|Atorvastatin 10 mg|After washout participants received atorvastatin 10 mg for a 4-week stabilization Run-in Period.
310807|NCT01218204|O1|Outcome|Washout|During the 4 weeks washout period, participants were asked to stop their lipid-modifying drugs.
310808|NCT01218204|O2|Outcome|GSK1292263 800 mg|Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.
310809|NCT01218204|O1|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants on 80 mg atorvastatin (either for >=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.
310810|NCT01218204|O11|Outcome|Placebo|After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
310811|NCT01218204|O10|Outcome|GSK1292263 800 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks
310812|NCT01218204|O9|Outcome|GSK1292263 300 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks
310813|NCT01218204|O8|Outcome|GSK1292263 100 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks
310814|NCT01218204|O7|Outcome|Atorvastatin 80 mg + Placebo|Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310815|NCT01218204|O6|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310816|NCT01218204|O5|Outcome|Atorvastatin 10 mg + Ezetimibe 10 mg|Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.
310817|NCT01218204|O4|Outcome|Atorvastatin 10 mg + Placebo|Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310818|NCT01218204|O3|Outcome|Atorvastatin 10 mg + GSK1292263 800 mg|Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310819|NCT01218204|O2|Outcome|Atorvastatin 10 mg + GSK1292263 300 mg|Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.
310820|NCT01218204|O1|Outcome|Atorvastatin 10 mg + GSK1292263 100 mg|Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.
310821|NCT01218204|O2|Outcome|Atorvastatin 80 mg|After washout participants received atorvastatin 80 mg for a 4-week stabilization Run-in Period.
310822|NCT01218204|O1|Outcome|Atorvastatin 10 mg|After washout participants received atorvastatin 10 mg for a 4-week stabilization Run-in Period.
310823|NCT01218204|O1|Outcome|Washout|During the 4 weeks washout period, participants were asked to stop their lipid-modifying drugs.
310824|NCT01218204|O2|Outcome|GSK1292263 800 mg|Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.
310825|NCT01218204|O1|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants on 80 mg atorvastatin (either for >=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.
310826|NCT01218204|O11|Outcome|Placebo|After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
310827|NCT01218204|O10|Outcome|GSK1292263 800 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks
310828|NCT01218204|O9|Outcome|GSK1292263 300 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks
310829|NCT01218204|O8|Outcome|GSK1292263 100 mg|After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks
310830|NCT01218204|O7|Outcome|Atorvastatin 80 mg + Placebo|Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310831|NCT01218204|O6|Outcome|Atorvastatin 80 mg + GSK1292263 800 mg|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310832|NCT01218204|O5|Outcome|Atorvastatin 10 mg + Ezetimibe 10 mg|Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.
310833|NCT01218204|O4|Outcome|Atorvastatin 10 mg + Placebo|Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310834|NCT01218204|O3|Outcome|Atorvastatin 10 mg + GSK1292263 800 mg|Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310835|NCT01218204|O2|Outcome|Atorvastatin 10 mg + GSK1292263 300 mg|Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.
311533|NCT01217112|O5|Outcome|Placebo|Contains excipients only
310836|NCT01218204|O1|Outcome|Atorvastatin 10 mg + GSK1292263 100 mg|Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.
310837|NCT01218204|O2|Outcome|Atorvastatin 80 mg|After washout participants received atorvastatin 80 mg for a 4-week stabilization Run-in Period.
310838|NCT01218204|O1|Outcome|Atorvastatin 10 mg|After washout participants received atorvastatin 10 mg for a 4-week stabilization Run-in Period.
310839|NCT01218204|O2|Outcome|Washout|During the 4 weeks washout period, participants were asked to stop their lipid-modifying drugs.
310840|NCT01218204|O1|Outcome|Pre-treatment|This was the time period prior to Day 1 of Washout Phase.
310841|NCT01218204|O2|Outcome|800 mg GSK1292263|Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.
310842|NCT01218204|O1|Outcome|80 mg Atorvastatin + 800 mg GSK1292263|Participants on 80 mg atorvastatin (either for >=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.
310843|NCT01218204|E17|Reported Event|Placebo (Part B Treatment)|After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks.
310844|NCT01218204|E16|Reported Event|GSK1292263 800 mg (Part B Treatment)|After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.
310845|NCT01218204|E15|Reported Event|GSK1292263 300 mg (Part B Treatment)|After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.
310846|NCT01218204|E14|Reported Event|GSK1292263 100 mg (Part B Treatment)|After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.
310847|NCT01218204|E13|Reported Event|Atorvastatin 80 mg + Placebo (Part B Treatment)|Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310848|NCT01218204|E12|Reported Event|Atorvastatin 80 mg + GSK1292263 800 mg (Part B Treatment)|Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310849|NCT01218204|E11|Reported Event|Atorvastatin 10 mg + Ezetimibe 10 mg (Part B Treatment)|Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.
310850|NCT01218204|E10|Reported Event|Atorvastatin 10 mg + Placebo (Part B Treatment)|Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.
310851|NCT01218204|E9|Reported Event|Atorvastatin 10 mg + GSK1292263 800 mg (Part B Treatment)|Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.
310852|NCT01218204|E8|Reported Event|Atorvastatin 10 mg + GSK1292263 300 mg (Part B Treatment)|Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.
310853|NCT01218204|E7|Reported Event|Atorvastatin 10 mg + GSK1292263 100 mg (Part B Treatment)|Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.
310854|NCT01218204|E6|Reported Event|Atorvastatin 80 mg (Part B Run-in)|After washout participants received atorvastatin 80 mg for a 4-week stabilization Run-in Period.
310855|NCT01218204|E5|Reported Event|Atorvastatin 10 mg (Part B Run-in)|After washout participants received atorvastatin 10 mg for a 4-week stabilization Run-in Period.
310856|NCT01218204|E4|Reported Event|Washout (Part B)|During the 4 weeks washout period, participants were asked to stop their lipid-modifying drugs.
310857|NCT01218204|E3|Reported Event|Pre-treatment (Part B)|This was the time period prior to Day 1 of Washout Phase.
310858|NCT01218204|E2|Reported Event|800 mg GSK1292263 (Part A)|Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.
310859|NCT01218204|E1|Reported Event|80 mg Atorvastatin + 800 mg GSK1292263 (Part A)|Participants on 80 mg atorvastatin (either for >=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.
310860|NCT01218126|B5|Baseline|Total|Total of all reporting groups
310861|NCT01218126|B4|Baseline|Losmapimod 15 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310862|NCT01218126|B3|Baseline|Losmapimod 7.5 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310863|NCT01218126|B2|Baseline|Losmapimod 2.5 mg|Participants received Losmapimod 2.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310864|NCT01218126|B1|Baseline|Placebo|Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310865|NCT01218126|P4|Participant Flow|Losmapimod 15 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310915|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310866|NCT01218126|P3|Participant Flow|Losmapimod 7.5 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310867|NCT01218126|P2|Participant Flow|Losmapimod 2.5 mg|Participants received Losmapimod 2.5 milligram (mg) tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310868|NCT01218126|P1|Participant Flow|Placebo|Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310869|NCT01218126|O4|Outcome|Losmapimod 15 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310870|NCT01218126|O3|Outcome|Losmapimod 7.5 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310871|NCT01218126|O2|Outcome|Losmapimod 2.5 mg|Participants received Losmapimod 2.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310872|NCT01218126|O1|Outcome|Placebo|Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310873|NCT01218126|O4|Outcome|Losmapimod 15 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310874|NCT01218126|O3|Outcome|Losmapimod 7.5 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310875|NCT01218126|O2|Outcome|Losmapimod 2.5 mg|Participants received Losmapimod 2.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310876|NCT01218126|O1|Outcome|Placebo|Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310877|NCT01218126|O4|Outcome|Losmapimod 15 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310878|NCT01218126|O3|Outcome|Losmapimod 7.5 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310879|NCT01218126|O2|Outcome|Losmapimod 2.5 mg|Participants received Losmapimod 2.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310880|NCT01218126|O1|Outcome|Placebo|Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310916|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311534|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
310881|NCT01218126|O4|Outcome|Losmapimod 15 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310882|NCT01218126|O3|Outcome|Losmapimod 7.5 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310883|NCT01218126|O2|Outcome|Losmapimod 2.5 mg|Participants received Losmapimod 2.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310884|NCT01218126|O1|Outcome|Placebo|Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310885|NCT01218126|O4|Outcome|Losmapimod 15 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310886|NCT01218126|O3|Outcome|Losmapimod 7.5 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310887|NCT01218126|O2|Outcome|Losmapimod 2.5 mg|Participants received Losmapimod 2.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310888|NCT01218126|O1|Outcome|Placebo|Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310889|NCT01218126|O4|Outcome|Losmapimod 15 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310890|NCT01218126|O3|Outcome|Losmapimod 7.5 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310891|NCT01218126|O2|Outcome|Losmapimod 2.5 mg|Participants received Losmapimod 2.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310892|NCT01218126|O1|Outcome|Placebo|Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310893|NCT01218126|O4|Outcome|Losmapimod 15 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310894|NCT01218126|O3|Outcome|Losmapimod 7.5 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310895|NCT01218126|O2|Outcome|Losmapimod 2.5 mg|Participants received Losmapimod 2.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310917|NCT01218113|O3|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
311535|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
310896|NCT01218126|O1|Outcome|Placebo|Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310897|NCT01218126|O4|Outcome|Losmapimod 15 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310898|NCT01218126|O3|Outcome|Losmapimod 7.5 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310899|NCT01218126|O2|Outcome|Losmapimod 2.5 mg|Participants received Losmapimod 2.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310900|NCT01218126|O1|Outcome|Placebo|Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310901|NCT01218126|E4|Reported Event|Losmapimod 15 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310902|NCT01218126|E3|Reported Event|Losmapimod 7.5 mg|Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310903|NCT01218126|E2|Reported Event|Losmapimod 2.5 mg|Participants received Losmapimod 2.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310904|NCT01218126|E1|Reported Event|Placebo|Participants received placebo matching Losmapimod tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
310905|NCT01218113|B4|Baseline|Total|Total of all reporting groups
310906|NCT01218113|B3|Baseline|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310907|NCT01218113|B2|Baseline|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
310908|NCT01218113|B1|Baseline|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310909|NCT01218113|P3|Participant Flow|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310910|NCT01218113|P2|Participant Flow|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
310911|NCT01218113|P1|Participant Flow|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310912|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310913|NCT01218113|O3|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
310914|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
311213|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
310918|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
310919|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310920|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310921|NCT01218113|O3|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
310922|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
310923|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310924|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310925|NCT01218113|O3|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
310926|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
310927|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310928|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310929|NCT01218113|O3|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
310930|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
310931|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310932|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310933|NCT01218113|O3|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
310934|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
310935|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310936|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310937|NCT01218113|O3|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
310938|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
310939|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310940|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311256|NCT01217892|P2|Participant Flow|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
310941|NCT01218113|O3|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
310942|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
310943|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310944|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310945|NCT01218113|O3|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
310946|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
310947|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310948|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310949|NCT01218113|O3|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
310950|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
310951|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310952|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310953|NCT01218113|O3|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
310954|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
310955|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310956|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310957|NCT01218113|O3|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
310958|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
310959|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310960|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310961|NCT01218113|O3|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
310962|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
310963|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311257|NCT01217892|P1|Participant Flow|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
310964|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310965|NCT01218113|O3|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
310966|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
310967|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310968|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310969|NCT01218113|O3|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
310970|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
310971|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310972|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310973|NCT01218113|O3|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
310974|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
310975|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310976|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310977|NCT01218113|O3|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
310978|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
310979|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310980|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310981|NCT01218113|O3|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
310982|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
310983|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310984|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310985|NCT01218113|O3|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
310986|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
311258|NCT01217892|O4|Outcome|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
310987|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310988|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310989|NCT01218113|O3|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
310990|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
310991|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310992|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310993|NCT01218113|O3|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
310994|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
310995|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310996|NCT01218113|O3|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310997|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
310998|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
310999|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311000|NCT01218113|O3|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
311001|NCT01218113|O2|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311002|NCT01218113|O1|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
311003|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311004|NCT01218113|O3|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
311005|NCT01218113|O2|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311006|NCT01218113|O1|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
311007|NCT01218113|O3|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311008|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
311009|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311259|NCT01217892|O3|Outcome|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
311010|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311011|NCT01218113|O3|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
311012|NCT01218113|O2|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311013|NCT01218113|O1|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
311014|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311015|NCT01218113|O3|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
311016|NCT01218113|O2|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311017|NCT01218113|O1|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
311018|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311019|NCT01218113|O3|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
311020|NCT01218113|O2|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311021|NCT01218113|O1|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
311022|NCT01218113|O4|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311023|NCT01218113|O3|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
311024|NCT01218113|O2|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311025|NCT01218113|O1|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
311026|NCT01218113|O3|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
311027|NCT01218113|O2|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311028|NCT01218113|O1|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311029|NCT01218113|O3|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
311030|NCT01218113|O2|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311031|NCT01218113|O1|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311032|NCT01218113|O3|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
311446|NCT01217307|E2|Reported Event|Placebo|"Placebo twice daily during 4 months~Placebo: Placebo twice daily during 4 months"
311033|NCT01218113|O2|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311034|NCT01218113|O1|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311035|NCT01218113|O2|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311036|NCT01218113|O1|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
311037|NCT01218113|O2|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311038|NCT01218113|O1|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
311039|NCT01218113|O2|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311040|NCT01218113|O1|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
311041|NCT01218113|O2|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311042|NCT01218113|O1|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
311043|NCT01218113|O2|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311044|NCT01218113|O1|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
311045|NCT01218113|O2|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311046|NCT01218113|O1|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
311047|NCT01218113|O3|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311048|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
311049|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311050|NCT01218113|O3|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311051|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
311052|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311053|NCT01218113|O3|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311054|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
311055|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311056|NCT01218113|O2|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311057|NCT01218113|O1|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
311058|NCT01218113|O3|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311059|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
311060|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311061|NCT01218113|O3|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311062|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
311063|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311064|NCT01218113|O2|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311065|NCT01218113|O1|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
311066|NCT01218113|O2|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311067|NCT01218113|O1|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
311068|NCT01218113|O3|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311069|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
311070|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311071|NCT01218113|O3|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311072|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
311073|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311074|NCT01218113|O2|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311075|NCT01218113|O1|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
311076|NCT01218113|O2|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311077|NCT01218113|O1|Outcome|HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.
311078|NCT01218113|O3|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311079|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
311214|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
311080|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311081|NCT01218113|O3|Outcome|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311082|NCT01218113|O2|Outcome|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
311083|NCT01218113|O1|Outcome|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311084|NCT01218113|E3|Reported Event|Control Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311085|NCT01218113|E2|Reported Event|2D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
311086|NCT01218113|E1|Reported Event|3D_HIV Group|HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
311087|NCT01218100|B5|Baseline|Total|Total of all reporting groups
311088|NCT01218100|B4|Baseline|Lisinopril|Lisinopril monotherapy group - starting dose level lisinopril 10mg
311089|NCT01218100|B3|Baseline|Nebivolol|Nebivolol monotherapy group - starting dose level nebivolol 5mg
311090|NCT01218100|B2|Baseline|Nebivolol + Lisinopril (Combination)|Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
311091|NCT01218100|B1|Baseline|Placebo|Placebo group - starting dose is placebo
311092|NCT01218100|P4|Participant Flow|Lisinopril|Lisinopril monotherapy group - starting dose level lisinopril 10mg
311093|NCT01218100|P3|Participant Flow|Nebivolol|Nebivolol monotherapy group - starting dose level nebivolol 5mg
311094|NCT01218100|P2|Participant Flow|Nebivolol + Lisinopril (Combination)|Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
311095|NCT01218100|P1|Participant Flow|Placebo|Placebo group - starting dose is placebo
311096|NCT01218100|O4|Outcome|Lisinopril|Lisinopril monotherapy group - starting dose level lisinopril 10mg
311097|NCT01218100|O3|Outcome|Nebivolol|Nebivolol monotherapy group - starting dose level nebivolol 5mg
311098|NCT01218100|O2|Outcome|Nebivolol + Lisinopril (Combination)|Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
311099|NCT01218100|O1|Outcome|Placebo|Placebo group - starting dose is placebo
311100|NCT01218100|O4|Outcome|Lisinopril|Lisinopril monotherapy group - starting dose level lisinopril 10mg
311101|NCT01218100|O3|Outcome|Nebivolol|Nebivolol monotherapy group - starting dose level nebivolol 5mg
311102|NCT01218100|O2|Outcome|Nebivolol + Lisinopril (Combination)|Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
311103|NCT01218100|O1|Outcome|Placebo|Placebo group - starting dose is placebo
311104|NCT01218100|E4|Reported Event|Lisinopril|Lisinopril monotherapy group - starting dose level lisinopril 10mg
311105|NCT01218100|E3|Reported Event|Nebivolol|Nebivolol monotherapy group - starting dose level nebivolol 5mg
311106|NCT01218100|E2|Reported Event|Nebivolol + Lisinopril (Combination)|Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
311107|NCT01218100|E1|Reported Event|Placebo|Placebo group - starting dose is placebo
311108|NCT01218087|B3|Baseline|Total|Total of all reporting groups
311109|NCT01218087|B2|Baseline|Moldable Positioner Device|moldable positioner device: This positioning device was used 24/24 hours as a comparison to the cranial cup device.
311110|NCT01218087|B1|Baseline|Cranial Cup Device|cranial cup device: The cranial cup device was used 12/24 hours (alternating with the moldable positioner device) and was evaluated for feasibility, safety and efficacy for preventing head shape deformity in the infant
311111|NCT01218087|P2|Participant Flow|Moldable Positioner Device|Moldable positioner device was used 24/24 hours as a comparison to the cranial cup and moldable positioner study arm.
311112|NCT01218087|P1|Participant Flow|Cranial Cup Device|The cranial cup device was used 12/24 hours and the moldable positioner device was used for positioning infants the remainder of the 24 hours.
311113|NCT01218087|O2|Outcome|Moldable Positioner Device|moldable positioner device: This positioning device was used 24/24 hours as a comparison to the cranial cup device.
311114|NCT01218087|O1|Outcome|Cranial Cup Device|cranial cup device: The cranial cup device was used 12/24 hours (alternating with the moldable positioner device) and was evaluated for feasibility, safety and efficacy for preventing head shape deformity in the infant. Although infants in this arm did use the moldable positioner, they were analyzed separately from the comparison group.
311115|NCT01218087|O2|Outcome|Moldable Positioner Device|moldable positioner device: This positioning device was used 24/24 hours as a comparison to the cranial cup device.
311116|NCT01218087|O1|Outcome|Cranial Cup Device|cranial cup device: The cranial cup device was used 12/24 hours (alternating with the moldable positioner device) and was evaluated for feasibility, safety and efficacy for preventing head shape deformity in the infant. Although infants in this arm did use the moldable positioner, they were analyzed separately from the comparison group.
311117|NCT01218087|E2|Reported Event|Moldable Positioner Device|moldable positioner device: This positioning device was used 24/24 hours as a comparison to the cranial cup device.
311215|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
311118|NCT01218087|E1|Reported Event|Cranial Cup Device|cranial cup device: The cranial cup device was used 12/24 hours (alternating with the moldable positioner device) and was evaluated for feasibility, safety and efficacy for preventing head shape deformity in the infant. Although infants in this arm did use the moldable positioner, they were analyzed separately from the comparison group.
311119|NCT01218009|B3|Baseline|Total|Total of all reporting groups
311120|NCT01218009|B2|Baseline|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
311121|NCT01218009|B1|Baseline|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
311122|NCT01218009|P2|Participant Flow|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
311123|NCT01218009|P1|Participant Flow|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
311124|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
311125|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
311126|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
311127|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
311128|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
311129|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
311130|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
311131|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
311132|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
311133|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
311134|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
311135|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
311136|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
311216|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
311137|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
311138|NCT01218009|E2|Reported Event|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
311139|NCT01218009|E1|Reported Event|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
311140|NCT01217957|B6|Baseline|Total|Total of all reporting groups
311141|NCT01217957|B5|Baseline|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311142|NCT01217957|B4|Baseline|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311143|NCT01217957|B3|Baseline|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311144|NCT01217957|B2|Baseline|Phase 1 :Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311145|NCT01217957|B1|Baseline|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311146|NCT01217957|P5|Participant Flow|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311147|NCT01217957|P4|Participant Flow|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311148|NCT01217957|P3|Participant Flow|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311149|NCT01217957|P2|Participant Flow|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311150|NCT01217957|P1|Participant Flow|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311151|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
311152|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle. for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311512|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311153|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
311154|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311155|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
311156|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311157|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
311158|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311159|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
311160|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311161|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
311162|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311163|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
311164|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311165|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
311217|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
311513|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311166|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311167|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
311168|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311169|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311170|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311171|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311172|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311173|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311174|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311175|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311176|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311177|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311178|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311179|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311218|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
311514|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311180|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311181|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311182|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311183|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311184|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311185|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311186|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311187|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311188|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311189|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311190|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311191|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311192|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311193|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
311219|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
311515|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311194|NCT01217957|O1|Outcome|Phase 2 :Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311195|NCT01217957|O1|Outcome|Phase 1: Ixazomib + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311196|NCT01217957|O1|Outcome|Phase 1: Ixazomib + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311197|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23. mg/m^2 in Phase 1.
311198|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311199|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311200|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle. for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311201|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311202|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311203|NCT01217957|E2|Reported Event|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311204|NCT01217957|E1|Reported Event|Phase 1: Ixazomib + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
311205|NCT01217944|B4|Baseline|Total|Total of all reporting groups
311206|NCT01217944|B3|Baseline|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
311207|NCT01217944|B2|Baseline|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
311208|NCT01217944|B1|Baseline|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
311209|NCT01217944|P3|Participant Flow|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
311210|NCT01217944|P2|Participant Flow|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
311211|NCT01217944|P1|Participant Flow|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
311212|NCT01217944|O1|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
311603|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311220|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
311221|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
311222|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
311223|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
311224|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
311225|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
311226|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
311227|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
311228|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
311229|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
311230|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
311231|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
311232|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
311233|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
311234|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
311235|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
311236|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
311237|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
311238|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
311239|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
311240|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
311241|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
311242|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
311243|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
311244|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
311245|NCT01217944|E4|Reported Event|Visudyne PDT: Grp III Without 0.5mg Ranibizumab From Month 3|After month 3 participants did not receive active ranibizumab
311246|NCT01217944|E3|Reported Event|Visudyne PDT: Grp III With 0.5mg Ranibizumab From Month 3|After month 3 participants received active ranibizumab, active vPDT or a combination of the two if needed.
311247|NCT01217944|E2|Reported Event|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
311248|NCT01217944|E1|Reported Event|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
311249|NCT01217892|B5|Baseline|Total|Total of all reporting groups
311250|NCT01217892|B4|Baseline|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
311251|NCT01217892|B3|Baseline|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
311252|NCT01217892|B2|Baseline|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
311253|NCT01217892|B1|Baseline|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
311254|NCT01217892|P4|Participant Flow|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
311255|NCT01217892|P3|Participant Flow|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
311260|NCT01217892|O2|Outcome|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
311261|NCT01217892|O1|Outcome|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
311262|NCT01217892|O4|Outcome|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
311263|NCT01217892|O3|Outcome|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
311264|NCT01217892|O2|Outcome|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
311265|NCT01217892|O1|Outcome|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
311266|NCT01217892|O4|Outcome|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
311267|NCT01217892|O3|Outcome|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
311268|NCT01217892|O2|Outcome|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
311269|NCT01217892|O1|Outcome|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
311270|NCT01217892|O4|Outcome|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
311271|NCT01217892|O3|Outcome|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
311272|NCT01217892|O2|Outcome|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
311273|NCT01217892|O1|Outcome|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
311274|NCT01217892|O4|Outcome|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
311275|NCT01217892|O3|Outcome|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
311276|NCT01217892|O2|Outcome|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
311277|NCT01217892|O1|Outcome|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
311278|NCT01217892|E4|Reported Event|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
311279|NCT01217892|E3|Reported Event|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
311280|NCT01217892|E2|Reported Event|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
311281|NCT01217892|E1|Reported Event|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
311282|NCT01217840|B3|Baseline|Total|Total of all reporting groups
311283|NCT01217840|B2|Baseline|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments. Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
311284|NCT01217840|B1|Baseline|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
311285|NCT01217840|P2|Participant Flow|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
311286|NCT01217840|P1|Participant Flow|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
311287|NCT01217840|O2|Outcome|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments. Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
311288|NCT01217840|O1|Outcome|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
311289|NCT01217840|O2|Outcome|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments. Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
311344|NCT01217814|E1|Reported Event|Placebo|SC injection of placebo 2 mL qw to match sarilumab and 0.5 mL q4w to match golimumab on top of MTX (15-25 mg) qw for 12 weeks.
311345|NCT01217801|B3|Baseline|Total|Total of all reporting groups
311516|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311290|NCT01217840|O1|Outcome|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
311291|NCT01217840|O2|Outcome|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments. Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
311292|NCT01217840|O1|Outcome|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
311293|NCT01217840|O2|Outcome|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments. Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
311294|NCT01217840|O1|Outcome|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
311295|NCT01217840|O2|Outcome|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments. Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
311296|NCT01217840|O1|Outcome|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
311297|NCT01217840|O2|Outcome|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments. Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
311298|NCT01217840|O1|Outcome|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
311299|NCT01217840|O2|Outcome|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments. Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
311300|NCT01217840|O1|Outcome|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
311301|NCT01217840|O2|Outcome|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments. Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
311302|NCT01217840|O1|Outcome|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
311303|NCT01217840|O2|Outcome|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
311304|NCT01217840|O1|Outcome|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
311305|NCT01217840|E2|Reported Event|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
311306|NCT01217840|E1|Reported Event|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
311307|NCT01217827|B3|Baseline|Total|Total of all reporting groups
311308|NCT01217827|B2|Baseline|Control|This group does not receive an intervention.
311309|NCT01217827|B1|Baseline|Clinical Reminder|"Reminder of potential candidacy for an implantable cardioverter defibrillator. The reminder is placed in the medical record with copy to the primary provider and any cardiologist managing the patient.~Clinical Reminder"
311310|NCT01217827|P2|Participant Flow|Control|This group does not receive an intervention.
311311|NCT01217827|P1|Participant Flow|Clinical Reminder|"Reminder of potential candidacy for an implantable cardioverter defibrillator. The reminder is placed in the medical record with copy to the primary provider and any cardiologist managing the patient.~Clinical Reminder"
311312|NCT01217827|O2|Outcome|Control|This group does not receive an intervention.
311313|NCT01217827|O1|Outcome|Clinical Reminder|"Reminder of potential candidacy for an implantable cardioverter defibrillator. The reminder is placed in the medical record with copy to the primary provider and any cardiologist managing the patient.~Clinical Reminder"
311314|NCT01217827|E2|Reported Event|Control|This group does not receive an intervention.
311315|NCT01217827|E1|Reported Event|Clinical Reminder|"Reminder of potential candidacy for an implantable cardioverter defibrillator. The reminder is placed in the medical record with copy to the primary provider and any cardiologist managing the patient.~Clinical Reminder"
311316|NCT01217814|B4|Baseline|Total|Total of all reporting groups
311317|NCT01217814|B3|Baseline|Sarilumab 150 mg|Sarilumab 150 mg SC injection qw and placebo (matched to golimumab) SC injection q4w on top of MTX (15-25 mg) qw for 12 weeks.
311318|NCT01217814|B2|Baseline|Golimumab 50 mg|Golimumab 50 mg SC injection q4w and placebo (matched to sarilumab) SC injection qw on top of MTX (15-25 mg) qw for 12 weeks.
311319|NCT01217814|B1|Baseline|Placebo|SC injection of placebo 2 mL qw to match sarilumab and 0.5 mL q4w to match golimumab on top of MTX (15-25 mg) qw for 12 weeks.
311320|NCT01217814|P3|Participant Flow|Sarilumab 150 mg|Sarilumab 150 mg SC injection qw and placebo (matched to golimumab) SC injection q4w on top of MTX (15-25 mg) qw for 12 weeks.
311321|NCT01217814|P2|Participant Flow|Golimumab 50 mg|Golimumab 50 mg SC injection q4w and placebo (matched to sarilumab) SC injection qw on top of MTX (15-25 mg) qw for 12 weeks.
311322|NCT01217814|P1|Participant Flow|Placebo|Subcutaneous (SC) injection of placebo 2 mL once a week (qw) to match sarilumab and 0.5 mL every 4 weeks (q4w) to match golimumab on top of methotrexate (MTX) (15-25 mg) qw for 12 weeks.
311323|NCT01217814|O1|Outcome|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw and placebo (matched to golimumab) SC injection q4w on top of MTX (15-25 mg) qw for 12 weeks.
311324|NCT01217814|O3|Outcome|Sarilumab 150 mg|Sarilumab 150 mg SC injection qw and placebo (matched to golimumab) SC injection q4w on top of MTX (15-25 mg) qw for 12 weeks.
311325|NCT01217814|O2|Outcome|Golimumab 50 mg|Golimumab 50 mg SC injection q4w and placebo (matched to sarilumab) SC injection qw on top of MTX (15-25 mg) qw for 12 weeks.
311326|NCT01217814|O1|Outcome|Placebo|SC injection of placebo 2 mL qw to match sarilumab and 0.5 mL q4w to match golimumab on top of MTX (15-25 mg) qw for 12 weeks.
311327|NCT01217814|O3|Outcome|Sarilumab 150 mg|Sarilumab 150 mg SC injection qw and placebo (matched to golimumab) SC injection q4w on top of MTX (15-25 mg) qw for 12 weeks.
311328|NCT01217814|O2|Outcome|Golimumab 50 mg|Golimumab 50 mg SC injection q4w and placebo (matched to sarilumab) SC injection qw on top of MTX (15-25 mg) qw for 12 weeks.
311329|NCT01217814|O1|Outcome|Placebo|SC injection of placebo 2 mL qw to match sarilumab and 0.5 mL q4w to match golimumab on top of MTX (15-25 mg) qw for 12 weeks.
311330|NCT01217814|O3|Outcome|Sarilumab 150 mg|Sarilumab 150 mg SC injection qw and placebo (matched to golimumab) SC injection q4w on top of MTX (15-25 mg) qw for 12 weeks.
311331|NCT01217814|O2|Outcome|Golimumab 50 mg|Golimumab 50 mg SC injection q4w and placebo (matched to sarilumab) SC injection qw on top of MTX (15-25 mg) qw for 12 weeks.
311332|NCT01217814|O1|Outcome|Placebo|SC injection of placebo 2 mL qw to match sarilumab and 0.5 mL q4w to match golimumab on top of MTX (15-25 mg) qw for 12 weeks.
311333|NCT01217814|O3|Outcome|Sarilumab 150 mg|Sarilumab 150 mg SC injection qw and placebo (matched to golimumab) SC injection q4w on top of MTX (15-25 mg) qw for 12 weeks.
311334|NCT01217814|O2|Outcome|Golimumab 50 mg|Golimumab 50 mg SC injection q4w and placebo (matched to sarilumab) SC injection qw on top of MTX (15-25 mg) qw for 12 weeks.
311335|NCT01217814|O1|Outcome|Placebo|SC injection of placebo 2 mL qw to match sarilumab and 0.5 mL q4w to match golimumab on top of MTX (15-25 mg) qw for 12 weeks.
311336|NCT01217814|O3|Outcome|Sarilumab 150 mg|Sarilumab 150 mg SC injection qw and placebo (matched to golimumab) SC injection q4w on top of MTX (15-25 mg) qw for 12 weeks.
311337|NCT01217814|O2|Outcome|Golimumab 50 mg|Golimumab 50 mg SC injection q4w and placebo (matched to sarilumab) SC injection qw on top of MTX (15-25 mg) qw for 12 weeks.
311338|NCT01217814|O1|Outcome|Placebo|SC injection of placebo 2 mL qw to match sarilumab and 0.5 mL q4w to match golimumab on top of MTX (15-25 mg) qw for 12 weeks.
311339|NCT01217814|O3|Outcome|Sarilumab 150 mg|Sarilumab 150 mg SC injection qw and placebo (matched to golimumab) SC injection q4w on top of MTX (15-25 mg) qw for 12 weeks.
311340|NCT01217814|O2|Outcome|Golimumab 50 mg|Golimumab 50 mg SC injection q4w and placebo (matched to sarilumab) SC injection qw on top of MTX (15-25 mg) qw for 12 weeks.
311341|NCT01217814|O1|Outcome|Placebo|SC injection of placebo 2 mL qw to match sarilumab and 0.5 mL q4w to match golimumab on top of MTX (15-25 mg) qw for 12 weeks.
311342|NCT01217814|E3|Reported Event|Sarilumab 150 mg|Sarilumab 150 mg SC injection qw and placebo (matched to golimumab) SC injection q4w on top of MTX (15-25 mg) qw for 12 weeks.
311343|NCT01217814|E2|Reported Event|Golimumab 50 mg|Golimumab 50 mg SC injection q4w and placebo (matched to sarilumab) SC injection qw on top of MTX (15-25 mg) qw for 12 weeks.
311440|NCT01217307|B2|Baseline|Placebo|"Placebo twice daily during 4 months~Placebo: Placebo twice daily during 4 months"
311346|NCT01217801|B2|Baseline|Ondanestron Orally Disintegrating Tablet|Ondanestron Orally Disintegrating Tablet (8 mg) followed by a 7 day wash out and then administered Ondanestron Orally Dissolving Filmstrip (8 mg); AUCs for each period will be calculated.
311347|NCT01217801|B1|Baseline|Ondanestron Orally Dissolving Filmstrip|Ondanestron Orally Dissolving Filmstrip (8 mg) followed by a 7 day wash out and then administered Ondanestron Orally Disintegrating tablets (8 mg); AUCs for each period will be calculated.
311348|NCT01217801|P2|Participant Flow|Ondansetron Orally Disintegrating Tablet Then OD Film|Ondansetron Orally Disintegrating Tablet AUC Ondansetron 8 mg then 7 days then Ondansetron Orally Disintegrating Film 8 mg measure AUC
311349|NCT01217801|P1|Participant Flow|Ondansetron Orally Dissolving Filmstrip Then ODT|Ondansetron Orally Dissolving Filmstrip 8 mg then 7 days then Ondansetron Orally Disintegrating Tablet 8 mg measure AUC
311350|NCT01217801|O2|Outcome|Tablet|tablet AUC
311351|NCT01217801|O1|Outcome|Film|AUC film strip
311352|NCT01217801|E2|Reported Event|Ondanestron Orally Disintegrating Tablet|Ondanestron Orally Disintegrating Tablet AUC
311353|NCT01217801|E1|Reported Event|Ondanestron Orally Dissolving Filmstrip|Ondanestron Orally Dissolving Filmstrip AUC
311354|NCT01217749|B4|Baseline|Total|Total of all reporting groups
311355|NCT01217749|B3|Baseline|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
311356|NCT01217749|B2|Baseline|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
311357|NCT01217749|B1|Baseline|Group 1|In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
311358|NCT01217749|P3|Participant Flow|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
311359|NCT01217749|P2|Participant Flow|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
311360|NCT01217749|P1|Participant Flow|Group 1|In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
311361|NCT01217749|O2|Outcome|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
311362|NCT01217749|O1|Outcome|Group 1|In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
311363|NCT01217749|O3|Outcome|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
311364|NCT01217749|O2|Outcome|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
311365|NCT01217749|O1|Outcome|Group 1|In Group 1, PCI-32765 420 mg PO daily was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
311366|NCT01217749|O3|Outcome|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
311367|NCT01217749|O2|Outcome|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
311368|NCT01217749|O1|Outcome|Group 1|In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
311369|NCT01217749|O3|Outcome|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
311370|NCT01217749|O2|Outcome|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
311371|NCT01217749|O1|Outcome|Group 1|In Group 1, PCI-32765 420 mg PO administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
311372|NCT01217749|E3|Reported Event|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
311373|NCT01217749|E2|Reported Event|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
311374|NCT01217749|E1|Reported Event|Group 1|In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
311375|NCT01217606|B3|Baseline|Total|Total of all reporting groups
311376|NCT01217606|B2|Baseline|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
311377|NCT01217606|B1|Baseline|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
311378|NCT01217606|P2|Participant Flow|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks in the Initial Treatment Phase followed by a 9 month Masked Extension.
311379|NCT01217606|P1|Participant Flow|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks in the Initial Treatment Phase followed by a 9 month Masked Extension.
311380|NCT01217606|O2|Outcome|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
311381|NCT01217606|O1|Outcome|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
311382|NCT01217606|O2|Outcome|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
311383|NCT01217606|O1|Outcome|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
311441|NCT01217307|B1|Baseline|Metformin|"metformin 500mg twice daily during 4 months~Metformin: Metformin 500mg twice daily during 4 months"
311384|NCT01217606|O2|Outcome|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
311385|NCT01217606|O1|Outcome|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
311386|NCT01217606|E2|Reported Event|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
311387|NCT01217606|E1|Reported Event|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
311388|NCT01217515|B4|Baseline|Total|Total of all reporting groups
311389|NCT01217515|B3|Baseline|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.~Placebo : 3 times daily"
311390|NCT01217515|B2|Baseline|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 4% cream : 3 times daily"
311391|NCT01217515|B1|Baseline|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 2% cream : 3 times daily"
311392|NCT01217515|P3|Participant Flow|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.~Placebo : 3 times daily"
311393|NCT01217515|P2|Participant Flow|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 4% cream : 3 times daily"
311394|NCT01217515|P1|Participant Flow|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 2% cream : 3 times daily"
311395|NCT01217515|O3|Outcome|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.~Placebo : 3 times daily"
311396|NCT01217515|O2|Outcome|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 4% cream : 3 times daily"
311397|NCT01217515|O1|Outcome|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 2% cream : 3 times daily"
311398|NCT01217515|O3|Outcome|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.~Placebo : 3 times daily"
311399|NCT01217515|O2|Outcome|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 4% cream : 3 times daily"
311400|NCT01217515|O1|Outcome|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 2% cream : 3 times daily"
311401|NCT01217515|O3|Outcome|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.~Placebo : 3 times daily"
311402|NCT01217515|O2|Outcome|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 4% cream : 3 times daily"
311403|NCT01217515|O1|Outcome|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 2% cream : 3 times daily"
311404|NCT01217515|E3|Reported Event|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.~Placebo : 3 times daily"
311405|NCT01217515|E2|Reported Event|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 4% cream : 3 times daily"
311406|NCT01217515|E1|Reported Event|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 2% cream : 3 times daily"
311407|NCT01217476|B3|Baseline|Total|Total of all reporting groups
311408|NCT01217476|B2|Baseline|Placebo|Matching placebo spray
311409|NCT01217476|B1|Baseline|Trafermin|Trafermin 0.01% spray
311410|NCT01217476|P2|Participant Flow|Placebo|Matching placebo spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
311411|NCT01217476|P1|Participant Flow|Trafermin|Trafermin 0.01% spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
311412|NCT01217476|O2|Outcome|Placebo|Matching placebo spray
311413|NCT01217476|O1|Outcome|Trafermin|Trafermin 0.01% spray
311414|NCT01217476|O2|Outcome|Placebo|Matching placebo spray
311415|NCT01217476|O1|Outcome|Trafermin|Trafermin 0.01% spray
311416|NCT01217476|E2|Reported Event|Placebo|Matching placebo spray
311417|NCT01217476|E1|Reported Event|Trafermin|Trafermin 0.01% spray
311418|NCT01217463|B3|Baseline|Total|Total of all reporting groups
311419|NCT01217463|B2|Baseline|Placebo|Matching placebo spray
311420|NCT01217463|B1|Baseline|Trafermin|Trafermin 0.01% spray
311421|NCT01217463|P2|Participant Flow|Placebo|Matching placebo spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
311442|NCT01217307|P2|Participant Flow|Placebo|"Placebo twice daily during 4 months~Placebo: Placebo twice daily during 4 months"
311443|NCT01217307|P1|Participant Flow|Metformin|"metformin 500mg twice daily during 4 months~Metformin: Metformin 500mg twice daily during 4 months"
311422|NCT01217463|P1|Participant Flow|Trafermin|Trafermin 0.01% spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
311423|NCT01217463|O2|Outcome|Matching Placebo Spray|Trafermin 0.01% spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
311424|NCT01217463|O1|Outcome|Trafermin 0.01% Spray|Trafermin 0.01% spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
311425|NCT01217463|O2|Outcome|Placebo|Matching placebo spray
311426|NCT01217463|O1|Outcome|Trafermin|Trafermin 0.01% spray
311427|NCT01217463|E2|Reported Event|Placebo|Matching placebo spray
311428|NCT01217463|E1|Reported Event|Trafermin|Trafermin 0.01% spray
311429|NCT01217411|B4|Baseline|Total|Total of all reporting groups
311430|NCT01217411|B3|Baseline|Arm II (WBRT or SRS and RO4929097)|"Patients with >= 4 brain lesions receive RO4929097 and undergo WBRT as in phase I and patients with =< 3 brain lesions receive RO4929097 and undergo SRS as in phase I.~Gamma-secretase/Notch signalling pathway inhibitor RO4929097: MTD Dosing cohorts: 5 mg, 10 mg and 20 mg given orally (3 days on/4 days off continuous) 1 day prior to beginning WBRT or 2 days prior to SRS.~For the SRS regiment: RO4929097 on Days 1-7 (no drug on days 8-14), weeks 1 and 2 only.~Stereotactic radiosurgery (SRS): Undergo radiosurgery; 20 Gy for tumors up to 1cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors >2.5 cm for patients with 3 or fewer brain lesions, and if overall patient status and tumor geometry amenable to this treatment modality~Whole-brain radiation therapy (WBRT): Undergo radiotherapy; 30-40 Gy over 10-20 fractions for patients with 4 or more brain lesions, or who are otherwise not eligible or appropriate for stereotactic radiosurgery"
311431|NCT01217411|B2|Baseline|Arm I (WBRT or SRS)|"Patients with >= 4 brain lesions undergo Whole-Brain Radiotherapy (WBRT) as in phase I and patients with =< 3 brain lesions undergo Stereotactic Radiosurgery (SRS) as in phase I.~Stereotactic radiosurgery (SRS): Undergo radiosurgery; 20 Gy for tumors up to 1cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors >2.5 cm for patients with 3 or fewer brain lesions, and if overall patient status and tumor geometry amenable to this treatment modality~Whole-brain radiation therapy (WBRT): Undergo radiotherapy; 30-40 Gy over 10-20 fractions for patients with 4 or more brain lesions, or who are otherwise not eligible or appropriate for stereotactic radiosurgery"
311432|NCT01217411|B1|Baseline|Phase I MTD Arm|"RO4929097 dose to be determined; Dosing cohorts: 5 mg, 10 mg and 20 mg~For patients with 4 or more lesions: Phase I WBRT+RO4929097; Begin RO4929097** (3 days on/4 days off continuous) 1 day prior to beginning WBRT~For patients with 3 or fewer lesions: Phase I SRS + RO4929097; Begin RO4929097** (3 days on/ 4 days off continuous) 2 days prior to SRS"
311433|NCT01217411|P3|Participant Flow|Arm II (WBRT or SRS and RO4929097)|"Patients with >= 4 brain lesions receive RO4929097 and undergo WBRT as in Phase I and patients with =< 3 brain lesions receive RO4929097 and undergo SRS as in Phase I.~Gamma-secretase/Notch signalling pathway inhibitor RO4929097: Maximum tolerated dose (MTD) derived from Phase I given orally (3 days on/4 days off continuous) 1 day prior to beginning WBRT or 2 days prior to SRS.~For the SRS regiment: RO4929097 on Days 1-7 (no drug on days 8-14), weeks 1 and 2 only.~Stereotactic radiosurgery (SRS): Undergo radiosurgery; 20 Gy for tumors up to 1cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors >2.5 cm for patients with 3 or fewer brain lesions, and if overall patient status and tumor geometry amenable to this treatment modality~Whole-brain radiation therapy (WBRT): Undergo radiotherapy; 30-40 Gy over 10-20 fractions for patients with 4 or more brain lesions, or who are otherwise not eligible or appropriate for stereotactic radiosurgery"
311434|NCT01217411|P2|Participant Flow|Arm I (WBRT or SRS)|"Patients with >= 4 brain lesions undergo WBRT as in Phase I and patients with =< 3 brain lesions undergo SRS as in Phase I.~Stereotactic radiosurgery (SRS): Undergo radiosurgery; 20 Gy for tumors up to 1cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors >2.5 cm for patients with 3 or fewer brain lesions, and if overall patient status and tumor geometry amenable to this treatment modality~Whole-brain radiation therapy (WBRT): Undergo radiotherapy; 30-40 Gy over 10-20 fractions for patients with 4 or more brain lesions, or who are otherwise not eligible or appropriate for stereotactic radiosurgery"
311435|NCT01217411|P1|Participant Flow|Phase I MTD Arm|"RO4929097 starting dose oral 5 mg; Dosing cohorts: 5 mg, 10 mg and 20 mg~For patients with 4 or more lesions: Phase I Whole-Brain Radiotherapy (WBRT) + RO4929097; Begin RO4929097** (3 days on/4 days off continuous) 1 day prior to beginning WBRT~For patients with 3 or fewer lesions: Phase I Stereotactic Radiosurgery (SRS) + RO4929097; Begin RO4929097** (3 days on/ 4 days off continuous) 2 days prior to SRS~For the SRS regiment: RO4929097 on Days 1-7 (no drug on days 8-14), weeks 1 and 2 only.~SRS: Radiosurgery 20 Gray (Gy) for tumors up to 1 cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors >2.5 cm for patients with 3 or fewer brain lesions. WBRT: Radiotherapy 30-40 Gy over 10-20 fractions for patients with 4 or more brain lesions, or who are otherwise not eligible or appropriate for SRS"
311436|NCT01217411|O1|Outcome|Phase I MTD Arm|"RO4929097 dose to be determined; Dosing cohorts: 5 mg, 10 mg and 20 mg~For patients with 4 or more lesions: Phase I WBRT+RO4929097; Begin RO4929097** (3 days on/4 days off continuous) 1 day prior to beginning WBRT~For patients with 3 or fewer lesions: Phase I SRS + RO4929097; Begin RO4929097** (3 days on/ 4 days off continuous) 2 days prior to SRS"
311437|NCT01217411|O1|Outcome|Phase I MTD Arm|"RO4929097 dose to be determined; Dosing cohorts: 5 mg, 10 mg and 20 mg~For patients with 4 or more lesions: Phase I WBRT+RO4929097; Begin RO4929097** (3 days on/4 days off continuous) 1 day prior to beginning WBRT~For patients with 3 or fewer lesions: Phase I SRS + RO4929097; Begin RO4929097** (3 days on/ 4 days off continuous) 2 days prior to SRS"
311438|NCT01217411|E1|Reported Event|Phase I MTD Arm|"RO4929097 dose to be determined; Dosing cohorts: 5 mg, 10 mg and 20 mg~For patients with 4 or more lesions: Phase I WBRT+RO4929097; Begin RO4929097** (3 days on/4 days off continuous) 1 day prior to beginning WBRT~For patients with 3 or fewer lesions: Phase I SRS + RO4929097; Begin RO4929097** (3 days on/ 4 days off continuous) 2 days prior to SRS"
311439|NCT01217307|B3|Baseline|Total|Total of all reporting groups
311447|NCT01217307|E1|Reported Event|Metformin|"metformin 500mg twice daily during 4 months~Metformin: Metformin 500mg twice daily during 4 months"
311448|NCT01217229|B1|Baseline|PLX3397|PLX3397 : Capsules administered once or twice daily, continuous dosing, at 900 mg/day.
311449|NCT01217229|P1|Participant Flow|PLX3397|PLX3397 : Capsules administered once or twice daily, continuous dosing, at 900 mg/day.
311450|NCT01217229|O1|Outcome|PLX3397|PLX3397 : Capsules administered once or twice daily, continuous dosing, at 900 mg/day.
311451|NCT01217229|E1|Reported Event|PLX3397|PLX3397 : Capsules administered once or twice daily, continuous dosing, at 900 mg/day.
311452|NCT01217112|B6|Baseline|Total|Total of all reporting groups
311453|NCT01217112|B5|Baseline|Placebo|Contains excipients only
311454|NCT01217112|B4|Baseline|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311455|NCT01217112|B3|Baseline|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311456|NCT01217112|B2|Baseline|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311457|NCT01217112|B1|Baseline|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311458|NCT01217112|P5|Participant Flow|Placebo|Contains excipients only
311459|NCT01217112|P4|Participant Flow|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311460|NCT01217112|P3|Participant Flow|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311461|NCT01217112|P2|Participant Flow|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311462|NCT01217112|P1|Participant Flow|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311463|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311464|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311465|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311466|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311467|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311468|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311469|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311470|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311471|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311472|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311473|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311474|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311475|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311476|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311477|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311478|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311479|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311480|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311481|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311482|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311483|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311484|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311485|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311486|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311487|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311488|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311489|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311490|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311491|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311492|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311493|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311494|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311495|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311496|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311497|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311498|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311499|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311500|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311501|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311502|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311503|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311504|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311505|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311506|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311507|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311508|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311509|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311510|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311511|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311536|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311537|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311538|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311539|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311540|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311541|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311542|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311543|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311544|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311545|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311546|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311547|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311548|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311549|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311550|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311551|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311552|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311553|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311554|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311555|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311556|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311557|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311558|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311559|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311560|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311561|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311562|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311563|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311564|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311565|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311566|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311567|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311568|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311569|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311570|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311571|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311572|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311573|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311574|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311575|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311576|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311577|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311578|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311579|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311580|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311581|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311582|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311583|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311584|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311585|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311586|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311587|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311588|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311589|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311590|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311591|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311592|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311593|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311594|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311595|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311596|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311597|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311598|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311599|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311600|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311601|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311602|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311604|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311605|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311606|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311607|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311608|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311609|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311610|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311611|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311612|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311613|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311614|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311615|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311616|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311617|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311618|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311619|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311620|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311621|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311622|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311623|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311624|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311625|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311626|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311627|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311628|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311629|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311630|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311631|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311632|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311633|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311634|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311635|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311636|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311637|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311638|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311639|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311640|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311641|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311642|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311643|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311644|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311645|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311646|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311647|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311648|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311649|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311650|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311651|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311652|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311653|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311654|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311655|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311656|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311657|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311658|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311659|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311660|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311661|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311662|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311663|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311664|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311665|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311666|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311667|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311668|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311669|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311670|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311671|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311672|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311673|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311674|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311675|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311676|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311677|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311678|NCT01217112|O5|Outcome|Placebo|Contains excipients only
311679|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311680|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311681|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311682|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311683|NCT01217112|E5|Reported Event|Placebo|Contains excipients only
311684|NCT01217112|E4|Reported Event|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
311685|NCT01217112|E3|Reported Event|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
311686|NCT01217112|E2|Reported Event|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
311687|NCT01217112|E1|Reported Event|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
311688|NCT01217073|B7|Baseline|Total|Total of all reporting groups
311689|NCT01217073|B6|Baseline|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
311690|NCT01217073|B5|Baseline|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
311691|NCT01217073|B4|Baseline|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
311692|NCT01217073|B3|Baseline|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
311693|NCT01217073|B2|Baseline|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
311694|NCT01217073|B1|Baseline|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
311695|NCT01217073|P8|Participant Flow|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
311696|NCT01217073|P7|Participant Flow|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly and placebo to metformin once daily for 66 weeks (extension period)
311697|NCT01217073|P6|Participant Flow|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
311698|NCT01217073|P5|Participant Flow|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
311699|NCT01217073|P4|Participant Flow|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
311700|NCT01217073|P3|Participant Flow|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
311701|NCT01217073|P2|Participant Flow|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
311702|NCT01217073|P1|Participant Flow|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
311703|NCT01217073|O6|Outcome|Placebo (Base)/Metformin (Extension)|Matching placebo to omarigliptin administered once weekly for 12 weeks (Base) followed by pioglitazone 30 mg administered once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension). Piogliatazone was removed by a protocol amendment and replaced with metformin starting dose 500 mg one daily up-titrated to 1000 mg twice daily.
311704|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)/25 mg (Extension)|Omarigliptin 25 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
311705|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)/25 mg (Extension)|Omarigliptin 10 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
311706|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)/25 mg (Extension)|Omarigliptin 3 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
311707|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)/25 mg (Extension)|Omarigliptin 1 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
311708|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)/25 mg (Extension)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
311709|NCT01217073|O2|Outcome|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
311710|NCT01217073|O1|Outcome|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)
311711|NCT01217073|O6|Outcome|Placebo (Base)/Metformin (Extension)|Matching placebo to omarigliptin administered once weekly for 12 weeks (Base) followed by pioglitazone 30 mg administered once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension). Piogliatazone was removed by a protocol amendment and replaced with metformin starting dose 500 mg one daily up-titrated to 1000 mg twice daily.
311712|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)/25 mg (Extension)|Omarigliptin 25 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
311713|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)/25 mg (Extension)|Omarigliptin 10 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
311752|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
311714|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)/25 mg (Extension)|Omarigliptin 3 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
311715|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)/25 mg (Extension)|Omarigliptin 1 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
311716|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)/25 mg (Extension)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
311717|NCT01217073|O2|Outcome|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
311718|NCT01217073|O1|Outcome|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)
311719|NCT01217073|O6|Outcome|Placebo (Base)/Metformin (Extension)|Matching placebo to omarigliptin administered once weekly for 12 weeks (Base) followed by pioglitazone 30 mg administered once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension). Piogliatazone was removed by a protocol amendment and replaced with metformin starting dose 500 mg one daily up-titrated to 1000 mg twice daily.
311720|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)/25 mg (Extension)|Omarigliptin 25 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
311721|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)/25 mg (Extension)|Omarigliptin 10 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
311722|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)/25 mg (Extension)|Omarigliptin 3 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
311723|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)/25 mg (Extension)|Omarigliptin 1 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
311724|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)/25 mg (Extension)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
311725|NCT01217073|O2|Outcome|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
311726|NCT01217073|O1|Outcome|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)
311727|NCT01217073|O6|Outcome|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
311728|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
311729|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
311730|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
311731|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
311732|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
311733|NCT01217073|O6|Outcome|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
311734|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
311735|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
311736|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
311737|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
311738|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
311739|NCT01217073|O2|Outcome|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
311740|NCT01217073|O1|Outcome|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)
311741|NCT01217073|O2|Outcome|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
311742|NCT01217073|O1|Outcome|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)
311743|NCT01217073|O6|Outcome|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
311744|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
311745|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
311746|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
311747|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
311748|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
311749|NCT01217073|O6|Outcome|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
311750|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
311751|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
311788|NCT01216735|B3|Baseline|Total|Total of all reporting groups
311753|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
311754|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
311755|NCT01217073|O6|Outcome|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
311756|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
311757|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
311758|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
311759|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
311760|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
311761|NCT01217073|E8|Reported Event|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
311762|NCT01217073|E7|Reported Event|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)
311763|NCT01217073|E6|Reported Event|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
311764|NCT01217073|E5|Reported Event|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
311765|NCT01217073|E4|Reported Event|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
311766|NCT01217073|E3|Reported Event|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
311767|NCT01217073|E2|Reported Event|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
311768|NCT01217073|E1|Reported Event|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
311769|NCT01216943|B1|Baseline|Triple Combination Therapy|One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
311770|NCT01216943|P1|Participant Flow|Triple Combination Therapy|One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
311771|NCT01216943|O1|Outcome|Triple Combination Therapy|One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
311772|NCT01216943|E1|Reported Event|Triple Combination Therapy|One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
311773|NCT01216761|B1|Baseline|Total Population|
311774|NCT01216761|P3|Participant Flow|PI Then IT Then CHG|"10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI~Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT~2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG"
311775|NCT01216761|P2|Participant Flow|IT Then CHG Then PI|"Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT~2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG~10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI"
311776|NCT01216761|P1|Participant Flow|CHG Then PI Then IT|"2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG~10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI~Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT"
311777|NCT01216761|O3|Outcome|Povidone Iodine (PI)|10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI
311778|NCT01216761|O2|Outcome|Iodine Tincture (IT)|Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT
311779|NCT01216761|O1|Outcome|Chlorhexidine Gluconate (CHG_|2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG
311780|NCT01216761|E3|Reported Event|PI Then IT Then CHG|"10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI~Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT~2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG"
311781|NCT01216761|E2|Reported Event|IT Then CHG Then PI|"Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT~2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG~10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI"
311782|NCT01216761|E1|Reported Event|CHG Then PI Then IT|"2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG~10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI~Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT"
311783|NCT01216748|B1|Baseline|Controls|health-lifetime non-smokers were enrolled
311784|NCT01216748|P1|Participant Flow|All Study Participants|healthy lifetime non smokers were challenged with 4 respiratory manouvers: quiet breathing, hypocapnic hyperventilation, hypercapnic hyperventilation, and eucapnic hyperventilation in random order.
311785|NCT01216748|O1|Outcome|Health Controls|Health lifetime non smokers were recruited.
311786|NCT01216748|O1|Outcome|Health Controls|Health lifetime non smokers were recruited.
311787|NCT01216748|E1|Reported Event|Health Controls|Health lifetime non smokers were recruited.
311789|NCT01216735|B2|Baseline|Non-smokers|this group served as controls for baseline data. No intervention or treatment were assigned to this group.
311790|NCT01216735|B1|Baseline|Smokers|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI)"
311791|NCT01216735|P2|Participant Flow|Placebo First, Then Fluticasone|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI) or placebo. The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI) or matching placebo"
311792|NCT01216735|P1|Participant Flow|Fluticasone First, Then Placebo|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI) or placebo. The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI) or matching placebo"
311793|NCT01216735|O2|Outcome|Placebo|"The current smokers will be given a 3-week treatment course of inhaled placebo MDI. The subjects and the investigators will be blinded to the random choice of inhaler.~Placebo: Placebo MDI"
311794|NCT01216735|O1|Outcome|Fluticasone|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI)"
311795|NCT01216735|O2|Outcome|Placebo|"The current smokers will be given a 3-week treatment course of inhaled placebo MDI. The subjects and the investigators will be blinded to the random choice of inhaler.~Placebo: Placebo MDI"
311796|NCT01216735|O1|Outcome|Fluticasone|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI)"
311797|NCT01216735|E2|Reported Event|Placebo|"The current smokers will be given a 3-week treatment course of inhaled placebo MDI. The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day for 3 weeks~Placebo: Placebo for 3 weeks"
311798|NCT01216735|E1|Reported Event|Fluticasone|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day for 3 weeks~Placebo: Placebo for 3 weeks"
311799|NCT01216631|B4|Baseline|Total|Total of all reporting groups
311800|NCT01216631|B3|Baseline|IV Infliximab|"intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight)~Infliximab: intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14"
311801|NCT01216631|B2|Baseline|IA Infliximab|"intra-articular injection of 100mg infliximab~Infliximab: intra-articular injection of 100mg infliximab given at baseline only"
311802|NCT01216631|B1|Baseline|IA Steroid|"Intra-articular injection of steroid (80mg depomedrone)~methylprednisolone: intra-articular injection of methylprednisolone (80mg given at baseline only)"
311803|NCT01216631|P3|Participant Flow|IV Infliximab|"intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight)~Infliximab: intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14"
311804|NCT01216631|P2|Participant Flow|IA Infliximab|"intra-articular injection of 100mg infliximab~Infliximab: intra-articular injection of 100mg infliximab given at baseline only"
311805|NCT01216631|P1|Participant Flow|IA Steroid|"Intra-articular injection of steroid (80mg depomedrone)~methylprednisolone: intra-articular injection of methylprednisolone (80mg given at baseline only)"
311806|NCT01216631|O3|Outcome|IV Infliximab|"intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight)~Infliximab: intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14"
311807|NCT01216631|O2|Outcome|IA Infliximab|"intra-articular injection of 100mg infliximab~Infliximab: intra-articular injection of 100mg infliximab given at baseline only"
311808|NCT01216631|O1|Outcome|IA Steroid|"Intra-articular injection of steroid (80mg depomedrone)~methylprednisolone: intra-articular injection of methylprednisolone (80mg given at baseline only)"
311809|NCT01216631|E3|Reported Event|IV Infliximab|"intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight)~Infliximab: intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14"
311810|NCT01216631|E2|Reported Event|IA Infliximab|"intra-articular injection of 100mg infliximab~Infliximab: intra-articular injection of 100mg infliximab given at baseline only"
311811|NCT01216631|E1|Reported Event|IA Steroid|"Intra-articular injection of steroid (80mg depomedrone)~methylprednisolone: intra-articular injection of methylprednisolone (80mg given at baseline only)"
311812|NCT01216410|B4|Baseline|Total|Total of all reporting groups
311813|NCT01216410|B3|Baseline|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
311814|NCT01216410|B2|Baseline|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
311815|NCT01216410|B1|Baseline|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
311816|NCT01216410|P3|Participant Flow|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
311817|NCT01216410|P2|Participant Flow|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
311818|NCT01216410|P1|Participant Flow|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
311819|NCT01216410|O3|Outcome|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
311820|NCT01216410|O2|Outcome|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
311821|NCT01216410|O1|Outcome|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
311822|NCT01216410|O3|Outcome|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
311823|NCT01216410|O2|Outcome|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
311824|NCT01216410|O1|Outcome|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
311825|NCT01216410|O3|Outcome|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
311826|NCT01216410|O2|Outcome|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
311827|NCT01216410|O1|Outcome|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
311828|NCT01216410|O3|Outcome|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
311829|NCT01216410|O2|Outcome|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
311830|NCT01216410|O1|Outcome|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
311831|NCT01216410|O3|Outcome|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
311832|NCT01216410|O2|Outcome|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
311833|NCT01216410|O1|Outcome|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
311834|NCT01216410|E3|Reported Event|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
311835|NCT01216410|E2|Reported Event|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
311836|NCT01216410|E1|Reported Event|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
311837|NCT01216397|B1|Baseline|All Participants|Treatment with standard batch and side batch
311838|NCT01216397|P2|Participant Flow|Side Batch Then Standard Batch|Linagliptin/metformin FDC tablet from side batch, then Linagliptin/metformin FDC tablet from standard batch
311839|NCT01216397|P1|Participant Flow|Standard Batch Then Side Batch|Linagliptin/metformin FDC tablet from standard batch, then Linagliptin/metformin FDC tablet from side batch
311840|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311841|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311842|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311843|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311844|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311845|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311846|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311847|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311848|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311849|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311850|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311851|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311852|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311853|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311854|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311855|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311856|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311857|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311858|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311859|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311860|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311861|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311862|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311863|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311864|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311865|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311866|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311867|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311868|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311869|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311870|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311871|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311872|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311873|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311874|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311875|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311876|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311877|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311878|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311879|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311880|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311881|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311882|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311883|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311884|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311885|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311886|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311887|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311888|NCT01216397|E2|Reported Event|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311889|NCT01216397|E1|Reported Event|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
311890|NCT01216319|B1|Baseline|Nipple Reconstruction Cylinder|Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
311891|NCT01216319|P1|Participant Flow|Nipple Reconstruction Cylinder|Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
311892|NCT01216319|O1|Outcome|Nipple Reconstruction Cylinder|Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
311893|NCT01216319|O1|Outcome|Nipple Reconstruction Cylinder|Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
311894|NCT01216319|E1|Reported Event|Nipple Reconstruction Cylinder|Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
311895|NCT01216241|B3|Baseline|Total|Total of all reporting groups
311896|NCT01216241|B2|Baseline|Saline Placebo|"Saline solution~Saline Placebo : 50 ml normal saline once daily~Daptomycin : 8 mg/kg once daily"
311897|NCT01216241|B1|Baseline|Daptomycin|"Daptomycin intravenous 8mg/kg once per day 5-10 days.~Daptomycin : 8 mg/kg once daily~Daptomycin : 8 MG/KG IV"
311898|NCT01216241|P2|Participant Flow|Saline Placebo|"Saline solution~Saline Placebo : 50 ml normal saline once daily~Daptomycin : 8 mg/kg once daily"
311899|NCT01216241|P1|Participant Flow|Daptomycin|"Daptomycin intravenous 8mg/kg once per day 5-10 days.~Daptomycin : 8 mg/kg once daily~Daptomycin : 8 MG/KG IV"
311900|NCT01216241|O2|Outcome|Saline Placebo|"Saline solution~Saline Placebo : 50 ml normal saline once daily~Daptomycin : 8 mg/kg once daily"
311901|NCT01216241|O1|Outcome|Daptomycin|"Daptomycin intravenous 8mg/kg once per day 5-10 days.~Daptomycin : 8 mg/kg once daily~Daptomycin : 8 MG/KG IV"
311902|NCT01216241|E2|Reported Event|Saline Placebo|"Saline solution~Saline Placebo : 50 ml normal saline once daily~Daptomycin : 8 mg/kg once daily"
311903|NCT01216241|E1|Reported Event|Daptomycin|"Daptomycin intravenous 8mg/kg once per day 5-10 days.~Daptomycin : 8 mg/kg once daily~Daptomycin : 8 MG/KG IV"
311904|NCT01216163|B4|Baseline|Total|Total of all reporting groups
311905|NCT01216163|B3|Baseline|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
311906|NCT01216163|B2|Baseline|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
311907|NCT01216163|B1|Baseline|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
311908|NCT01216163|P3|Participant Flow|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
311909|NCT01216163|P2|Participant Flow|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
311910|NCT01216163|P1|Participant Flow|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
311911|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
311912|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
311913|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
311914|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
311915|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
311916|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
311917|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
311918|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
311919|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
311920|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
311921|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
311922|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
311923|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
311924|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
311925|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
311926|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
311927|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
311928|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
311929|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
311930|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
311931|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
311932|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
311933|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
311934|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
311935|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
311936|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
311937|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
311938|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
311939|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
311940|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
311941|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
311942|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
311943|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
311944|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
311945|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
311946|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
311947|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
311948|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
311949|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
311950|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
311951|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
311952|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
311953|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
311954|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
311955|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
311956|NCT01216163|E3|Reported Event|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
311957|NCT01216163|E2|Reported Event|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
311958|NCT01216163|E1|Reported Event|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
311959|NCT01216072|B3|Baseline|Total|Total of all reporting groups
311960|NCT01216072|B2|Baseline|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
311961|NCT01216072|B1|Baseline|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
311962|NCT01216072|P2|Participant Flow|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
311963|NCT01216072|P1|Participant Flow|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
311964|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
311965|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
311966|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
311967|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
311968|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
311969|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
311970|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
311971|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
311972|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
311973|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
311974|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
311975|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
311976|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
311977|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
311978|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
311979|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
311980|NCT01216072|O3|Outcome|Extension Fingolimod Period|An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
311981|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
311982|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
311983|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
311984|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
311985|NCT01216072|E3|Reported Event|Fingolimod Extension Phase|An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
311986|NCT01216072|E2|Reported Event|Standard MS DMT|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
311987|NCT01216072|E1|Reported Event|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
311988|NCT01215981|B3|Baseline|Total|Total of all reporting groups
311989|NCT01215981|B2|Baseline|HSCT Recipients Who Were Randomized to 2 Vaccine Doses|
311990|NCT01215981|B1|Baseline|HSCT Recipients Who Were Randomized to 1 Vaccine Dose|
311991|NCT01215981|P2|Participant Flow|HSCT Recipients Who Were Randomized to 2 Vaccine Doses|
311992|NCT01215981|P1|Participant Flow|HSCT Recipients Who Were Randomized to 1 Vaccine Dose|
311993|NCT01215981|O2|Outcome|HSCT Recipients Who Were Randomized to 2 Vaccine Doses|Allogeneic hematopoietic stem cell transplant (HSCT) recipients who received 2 doses (day of enrollment and 4 weeks after later) of seasonal influenza vaccine after transplant.
311994|NCT01215981|O1|Outcome|HSCT Recipients Who Were Randomized to 1 Vaccine Dose|Allogeneic hematopoietic stem cell transplant (HSCT) recipients who received 1 dose (day of enrollment) of seasonal influenza vaccine after transplant.
311995|NCT01215981|O2|Outcome|HSCT Recipients Who Were Randomized to 2 Vaccine Doses|Allogeneic hematopoietic stem cell transplant (HSCT) recipients who received 2 doses (day of enrollment and 4 weeks after later) of seasonal influenza vaccine after transplant.
311996|NCT01215981|O1|Outcome|HSCT Recipients Who Were Randomized to 1 Vaccine Dose|Allogeneic hematopoietic stem cell transplant (HSCT) recipients who received 1 dose (day of enrollment) of seasonal influenza vaccine after transplant.
311997|NCT01215981|E2|Reported Event|HSCT Recipients Who Were Randomized to 2 Vaccine Doses|
311998|NCT01215981|E1|Reported Event|HSCT Recipients Who Were Randomized to 1 Vaccine Dose|
311999|NCT01215968|B3|Baseline|Total|Total of all reporting groups
312000|NCT01215968|B2|Baseline|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
312001|NCT01215968|B1|Baseline|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
312002|NCT01215968|P2|Participant Flow|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
312003|NCT01215968|P1|Participant Flow|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
312004|NCT01215968|O3|Outcome|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 mg LY2189265 on Weeks 2 to 5.
312005|NCT01215968|O2|Outcome|Placebo (Week 1)|Participants received placebo on Week 1 and went on to receive once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
312006|NCT01215968|O1|Outcome|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
312007|NCT01215968|O2|Outcome|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
312008|NCT01215968|O1|Outcome|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
312009|NCT01215968|O2|Outcome|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
312010|NCT01215968|O1|Outcome|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
312011|NCT01215968|O2|Outcome|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
312012|NCT01215968|O1|Outcome|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
312013|NCT01215968|O2|Outcome|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
312014|NCT01215968|O1|Outcome|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
312015|NCT01215968|E3|Reported Event|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 mg LY2189265 on Weeks 2 to 5.
312016|NCT01215968|E2|Reported Event|Placebo (Week 1)|Participants received placebo on Week 1 and went on to receive once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
312017|NCT01215968|E1|Reported Event|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
312018|NCT01215955|B5|Baseline|Total|Total of all reporting groups
312019|NCT01215955|B4|Baseline|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312020|NCT01215955|B3|Baseline|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312021|NCT01215955|B2|Baseline|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based dose was on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312022|NCT01215955|B1|Baseline|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312023|NCT01215955|P4|Participant Flow|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312024|NCT01215955|P3|Participant Flow|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312025|NCT01215955|P2|Participant Flow|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312026|NCT01215955|P1|Participant Flow|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312027|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312028|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312107|NCT01215851|P6|Participant Flow|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
312159|NCT01215786|O3|Outcome|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
312029|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312030|NCT01215955|O1|Outcome|Study A Q1D|"Insulin Lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312031|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312032|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312033|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312034|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312035|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312036|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312037|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312038|NCT01215955|O1|Outcome|Study A Q1D|"Insulin Lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312039|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312040|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312041|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312042|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312043|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312154|NCT01215786|P2|Participant Flow|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
312044|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312045|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312046|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312047|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312048|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312049|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312050|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312051|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312052|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312053|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312054|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312055|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312056|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312057|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312058|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312160|NCT01215786|O2|Outcome|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
312059|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312060|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312061|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312062|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312063|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312064|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312065|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312066|NCT01215955|O1|Outcome|Study A Q1D|"Insulin Lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312067|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312068|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312069|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312070|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312071|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312072|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312073|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312231|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
312074|NCT01215955|O1|Outcome|Study A Q1D|"Insulin Lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312075|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312076|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312077|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312078|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312079|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312080|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312081|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312082|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312083|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312084|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312085|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312086|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312087|NCT01215955|E4|Reported Event|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312088|NCT01215955|E3|Reported Event|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
312232|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
312089|NCT01215955|E2|Reported Event|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312090|NCT01215955|E1|Reported Event|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
312091|NCT01215929|B3|Baseline|Total|Total of all reporting groups
312092|NCT01215929|B2|Baseline|Placebo|Placebo: Thirty-four treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility in this 4-week, double-blind, placebo-controlled, clinical trial and be inducted onto d-amphetamine during week 1 of the study. 17 Participants were randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral placebo tablets twice daily for 2 weeks.
312093|NCT01215929|B1|Baseline|Dextroamphetamine|Dextroamphetamine: Thirty-five treatment-seeking methamphetamine dependent volunteers were admitted to a residential facility and inducted onto d-amphetamine during week 1 of the study. 18 Participants were be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks.
312094|NCT01215929|P2|Participant Flow|Placebo|Placebo: Thirty-four treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility in this 4-week, double-blind, placebo-controlled, clinical trial and be inducted onto d-amphetamine during week 1 of the study. 17 Participants were randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral placebo tablets twice daily for 2 weeks.
312095|NCT01215929|P1|Participant Flow|Dextroamphetamine|Dextroamphetamine: Thirty-five treatment-seeking methamphetamine dependent volunteers were admitted to a residential facility and inducted onto d-amphetamine during week 1 of the study. 18 Participants were be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks.
312096|NCT01215929|O2|Outcome|Placebo|Placebo: Thirty-five treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility in this 4-week, double-blind, placebo-controlled, clinical trial and be inducted onto d-amphetamine during week 1 of the study. 17 Participants were randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral placebo tablets twice daily for 2 weeks.
312097|NCT01215929|O1|Outcome|Dextroamphetamine|Dextroamphetamine: Thirty-five treatment-seeking methamphetamine dependent volunteers were admitted to a residential facility and inducted onto d-amphetamine during week 1 of the study. 18 Participants were be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks.
312098|NCT01215929|E2|Reported Event|Placebo|Placebo: Thirty-four treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility in this 4-week, double-blind, placebo-controlled, clinical trial and be inducted onto d-amphetamine during week 1 of the study. 17 Participants were randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral placebo tablets twice daily for 2 weeks.
312099|NCT01215929|E1|Reported Event|Dextroamphetamine|Dextroamphetamine: Thirty-five treatment-seeking methamphetamine dependent volunteers were admitted to a residential facility and inducted onto d-amphetamine during week 1 of the study. 18 Participants were be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks.
312100|NCT01215851|B7|Baseline|Total|Total of all reporting groups
312101|NCT01215851|B6|Baseline|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
312102|NCT01215851|B5|Baseline|Rifafour e-275 mg|Rifafour e-275 administered once daily with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
312103|NCT01215851|B4|Baseline|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets and pyrazinamide administered once daily in 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
312104|NCT01215851|B3|Baseline|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
312105|NCT01215851|B2|Baseline|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
312106|NCT01215851|B1|Baseline|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
312155|NCT01215786|P1|Participant Flow|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
312108|NCT01215851|P5|Participant Flow|Rifafour e-275 mg|Rifafour e-275 administered once daily on Days 1-14 with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
312109|NCT01215851|P4|Participant Flow|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
312110|NCT01215851|P3|Participant Flow|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
312111|NCT01215851|P2|Participant Flow|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
312112|NCT01215851|P1|Participant Flow|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
312113|NCT01215851|O6|Outcome|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
312114|NCT01215851|O5|Outcome|Rifafour e-275 mg|Rifafour e-275 administered once daily on Days 1-14 with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
312115|NCT01215851|O4|Outcome|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
312116|NCT01215851|O3|Outcome|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
312117|NCT01215851|O2|Outcome|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
312118|NCT01215851|O1|Outcome|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
312119|NCT01215851|O6|Outcome|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
312120|NCT01215851|O5|Outcome|Rifafour e-275 mg|Rifafour e-275 administered once daily on Days 1-14 with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
312121|NCT01215851|O4|Outcome|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
312122|NCT01215851|O3|Outcome|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
312123|NCT01215851|O2|Outcome|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
312124|NCT01215851|O1|Outcome|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
312125|NCT01215851|O6|Outcome|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
312126|NCT01215851|O5|Outcome|Rifafour e-275 mg|Rifafour e-275 administered once daily on Days 1-14 with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
312156|NCT01215786|O3|Outcome|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
312157|NCT01215786|O2|Outcome|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
312158|NCT01215786|O1|Outcome|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
312127|NCT01215851|O4|Outcome|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
312128|NCT01215851|O3|Outcome|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
312129|NCT01215851|O2|Outcome|TMC207 and Pyrazinamide|MC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
312130|NCT01215851|O1|Outcome|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
312131|NCT01215851|O6|Outcome|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
312132|NCT01215851|O5|Outcome|Rifafour e-275 mg|Rifafour e-275 administered once daily on Days 1-14 with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
312133|NCT01215851|O4|Outcome|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
312134|NCT01215851|O3|Outcome|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
312135|NCT01215851|O2|Outcome|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
312136|NCT01215851|O1|Outcome|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
312137|NCT01215851|O6|Outcome|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
312138|NCT01215851|O5|Outcome|Rifafour e-275 mg|Rifafour e-275 administered once daily on Days 1-14 with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
312139|NCT01215851|O4|Outcome|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
312140|NCT01215851|O3|Outcome|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
312141|NCT01215851|O2|Outcome|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
312142|NCT01215851|O1|Outcome|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
312143|NCT01215851|E6|Reported Event|TMC207 and PA-824|TMC207 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 200 mg
312144|NCT01215851|E5|Reported Event|Rifafour e-275 mg|Rifafour e-275 275 mg
312145|NCT01215851|E4|Reported Event|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 200 mg and pyrazinamide (dosed by weight) and moxifloxacin 400 mg
312146|NCT01215851|E3|Reported Event|PA-824 and Pyrazinamide|PA-824 200mg and pyrazinamide (dosed by weight)and moxifloxacin placebo
312147|NCT01215851|E2|Reported Event|TMC207 and Pyrazinamide|TMC207 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide (dosed by weight)
312148|NCT01215851|E1|Reported Event|TMC207|TMC207 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide placebo
312149|NCT01215786|B4|Baseline|Total|Total of all reporting groups
312150|NCT01215786|B3|Baseline|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
312151|NCT01215786|B2|Baseline|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
312152|NCT01215786|B1|Baseline|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
312153|NCT01215786|P3|Participant Flow|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
312161|NCT01215786|O1|Outcome|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
312162|NCT01215786|O3|Outcome|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
312163|NCT01215786|O2|Outcome|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
312164|NCT01215786|O1|Outcome|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
312165|NCT01215786|E3|Reported Event|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
312166|NCT01215786|E2|Reported Event|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
312167|NCT01215786|E1|Reported Event|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
312168|NCT01215734|B3|Baseline|Total|Total of all reporting groups
312169|NCT01215734|B2|Baseline|Standard Dose Trivalent Inactivated Flu Vaccine|"Twenty Adult stem cell transplant recipients at least 6 months post-transplant will receive standard dose trivalent influenza vaccine.~Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1."
312170|NCT01215734|B1|Baseline|High-Dose Trivalent Inactivated Influenza Vaccine|"Forty adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive high dose trivalent influenza vaccine~High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1"
312171|NCT01215734|P2|Participant Flow|Standard Dose Trivalent Inactivated Flu Vaccine|"Twenty Adult stem cell transplant recipients at least 6 months post-transplant will receive standard dose trivalent influenza vaccine.~Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1."
312172|NCT01215734|P1|Participant Flow|High-Dose Trivalent Inactivated Influenza Vaccine|"Forty adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive high dose trivalent influenza vaccine~High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1"
312173|NCT01215734|O2|Outcome|Standard Dose Trivalent Inactivated Flu Vaccine|Standard Dose TIV : Adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive SD (15 µg/per antigen) TIV on visit 1.
312174|NCT01215734|O1|Outcome|High-Dose Trivalent Inactivated Influenza Vaccine|High Dose: Adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive HD TIV (60 micrograms [µg] per antigen) on visit 1
312175|NCT01215734|O2|Outcome|Standard Dose Trivalent Inactivated Flu Vaccine|Standard Dose TIV : Adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive SD (15 µg/per antigen) TIV on visit 1.
312176|NCT01215734|O1|Outcome|High-Dose Trivalent Inactivated Influenza Vaccine|High Dose: Adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive HD TIV (60 micrograms [µg] per antigen) on visit 1
312177|NCT01215734|E2|Reported Event|Standard Dose Trivalent Inactivated Flu Vaccine|"Twenty Adult stem cell transplant recipients at least 6 months post transplant will receive standard dose trivalent influenza vaccine.~Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1."
312178|NCT01215734|E1|Reported Event|High-Dose Trivalent Inactivated Influenza Vaccine|"Forty adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive high dose trivalent influenza vaccine~High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1"
312179|NCT01215721|B1|Baseline|Vesicare|Vesicare™ (Solifenacin) : 5 mg daily
312180|NCT01215721|P1|Participant Flow|Vesicare|Vesicare™ (Solifenacin) : 5 mg daily
312181|NCT01215721|O1|Outcome|Vesicare, 5mg Treatment Group|Vesicare™ (Solifenacin) : 5 mg daily
312182|NCT01215721|E1|Reported Event|Vesicare, 5mg Treatment Group|Vesicare™ (Solifenacin) : 5 mg daily
312183|NCT01215695|B3|Baseline|Total|Total of all reporting groups
312184|NCT01215695|B2|Baseline|Intervention|"Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).~aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor."
312185|NCT01215695|B1|Baseline|Control|"Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)~Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope"
312186|NCT01215695|P2|Participant Flow|Intervention|"Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).~aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor."
312187|NCT01215695|P1|Participant Flow|Control|"Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)~Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope"
312188|NCT01215695|O2|Outcome|Intervention|"Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).~aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor."
312189|NCT01215695|O1|Outcome|Control|"Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)~Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope"
312190|NCT01215695|O2|Outcome|Intervention|"Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).~aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor."
312233|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
312191|NCT01215695|O1|Outcome|Control|"Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)~Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope"
312192|NCT01215695|O2|Outcome|Intervention|"Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).~aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor."
312193|NCT01215695|O1|Outcome|Control|"Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)~Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope"
312194|NCT01215695|O2|Outcome|Intervention|"Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).~aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor."
312195|NCT01215695|O1|Outcome|Control|"Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)~Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope"
312196|NCT01215695|O2|Outcome|Intervention|"Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).~aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor."
312197|NCT01215695|O1|Outcome|Control|"Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)~Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope"
312198|NCT01215695|E2|Reported Event|Intervention|"Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).~aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor."
312199|NCT01215695|E1|Reported Event|Control|"Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)~Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope"
312200|NCT01215643|B6|Baseline|Total|Total of all reporting groups
312201|NCT01215643|B5|Baseline|PEG+RBV|PEG and RBV during Weeks 1 to 24.
312202|NCT01215643|B4|Baseline|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
312203|NCT01215643|B3|Baseline|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
312204|NCT01215643|B2|Baseline|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
312205|NCT01215643|B1|Baseline|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
312206|NCT01215643|P5|Participant Flow|PEG+RBV|PEG and RBV during Weeks 1 to 24.
312207|NCT01215643|P4|Participant Flow|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with peginterferon alfa-2a (PEG) during Weeks 2 to 24.
312208|NCT01215643|P3|Participant Flow|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
312209|NCT01215643|P2|Participant Flow|ALV 600 mg+RBV|ALV 600 mg BID with ribavirin (RBV) for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
312210|NCT01215643|P1|Participant Flow|ALV 1000 mg|Alisporivir (ALV) 600 mg twice daily (BID) for 1 week, followed by ALV 1000 mg once daily (QD) during Weeks 2 to 24.
312211|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
312212|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
312213|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
312214|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
312215|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
312216|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
312217|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
312218|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
312219|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
312220|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
312221|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
312222|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
312223|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
312224|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
312225|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
312226|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
312227|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
312228|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
312229|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
312230|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
312234|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
312235|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
312236|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
312237|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
312238|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
312239|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
312240|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
312241|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
312242|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
312243|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
312244|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
312245|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
312246|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
312247|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
312248|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
312249|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
312250|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
312251|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
312252|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
312253|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
312254|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
312255|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
312256|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
312257|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
312258|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
312259|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
312260|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
312261|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
312262|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
312263|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
312264|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
312265|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
312266|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
312267|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
312268|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
312269|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
312270|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
312271|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
312272|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
312273|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
312274|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
312275|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
312276|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
312277|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
312278|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
312279|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
312280|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
312281|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
312282|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
312283|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
312284|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
312285|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
312286|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
312287|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
312288|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
312289|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
312290|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
312291|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
312292|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
312293|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
312294|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
312295|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
312296|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
312297|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
312298|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
312299|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
312300|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
312301|NCT01215643|E10|Reported Event|PEG+RBV: Post-treatment AEs|AEs occurring after end of treatment in participants receiving PEG and RBV during Weeks 1 to 24.
312302|NCT01215643|E9|Reported Event|ALV 600 mg+PEG: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
312303|NCT01215643|E8|Reported Event|ALV 800 mg+RBV: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
312304|NCT01215643|E7|Reported Event|ALV 600 mg+RBV: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
312305|NCT01215643|E6|Reported Event|ALV 1000 mg: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
312306|NCT01215643|E5|Reported Event|PEG+RBV: On-treatment AEs|AEs occurring while on treatment in participants receiving PEG and RBV during Weeks 1 to 24.
312307|NCT01215643|E4|Reported Event|ALV 600 mg+PEG: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
312308|NCT01215643|E3|Reported Event|ALV 800 mg+RBV: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
312309|NCT01215643|E2|Reported Event|ALV 600 mg+RBV: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
312310|NCT01215643|E1|Reported Event|ALV 1000 mg: On-treatment AEs|Adverse events (AEs) occurring while on treatment in participants receiving ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
312311|NCT01215513|B1|Baseline|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals
312312|NCT01215513|P1|Participant Flow|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
312313|NCT01215513|O1|Outcome|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals
312314|NCT01215513|O1|Outcome|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
312315|NCT01215513|O1|Outcome|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
312316|NCT01215513|O1|Outcome|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
312317|NCT01215513|E1|Reported Event|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
312318|NCT01215435|B3|Baseline|Total|Total of all reporting groups
312319|NCT01215435|B2|Baseline|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
312320|NCT01215435|B1|Baseline|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
312321|NCT01215435|P2|Participant Flow|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
312322|NCT01215435|P1|Participant Flow|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
312323|NCT01215435|O2|Outcome|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
312437|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312324|NCT01215435|O1|Outcome|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
312325|NCT01215435|O2|Outcome|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
312326|NCT01215435|O1|Outcome|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
312327|NCT01215435|O2|Outcome|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
312328|NCT01215435|O1|Outcome|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
312329|NCT01215435|E2|Reported Event|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
312330|NCT01215435|E1|Reported Event|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
312331|NCT01215422|B5|Baseline|Total|Total of all reporting groups
312332|NCT01215422|B4|Baseline|GS Intubaton Participants|Children intubated with the GlideScope system (GS) video laryngoscope (VLS)
312333|NCT01215422|B3|Baseline|KS Intubation Participants|Children intubated with the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope (VLS)
312334|NCT01215422|B2|Baseline|Baseline Intubation Participants|Children intubated at baseline using the standard laryngoscope blade of the anesthesiologist's choice
312335|NCT01215422|B1|Baseline|Overall Anesthesiologists|Baseline intubation times were obtained on a convenience sample of 20 children using the standard laryngoscope blade of their choice. Then anesthesiologists were randomized to complete either 20 intubations with the GlideScope system (GS) video laryngoscope (VLS) or 20 with the Karl Storz Direct Coupled Interface DCI (KS) VLS first. Once they had intubated 20 children with the VLS to which they were randomized, they crossed over to use the alternate VLS for 20 intubations.
312336|NCT01215422|P4|Participant Flow|GS Intubation Participants|Children intubated with the GlideScope system (GS) VLS
312337|NCT01215422|P3|Participant Flow|KS Intubation Participants|Children intubated with the Karl Storz Direct Coupled Interface DCI (KS) VLS
312338|NCT01215422|P2|Participant Flow|Baseline Intubation Participants|Children intubated at baseline using the standard laryngoscope blade of the anesthesiologist's choice.
312339|NCT01215422|P1|Participant Flow|Overall Anesthesiologists|Baseline intubation times were obtained on a convenience sample of 20 children using the standard laryngoscope blade of their choice. Then anesthesiologists were randomized to complete either 20 intubations with the GlideScope system (GS) video laryngoscope (VLS) or 20 with the Karl Storz Direct Coupled Interface DCI (KS) VLS first. Once they had intubated 20 children with the VLS to which they were randomized, they crossed over to use the alternate VLS for 20 intubations.
312340|NCT01215422|O2|Outcome|KS Intubations|Anesthesiologists who intubated minimum 18 children with the KS VLS
312341|NCT01215422|O1|Outcome|GS Intubations|Anesthesiologists who intubated minimum 18 children with the GS VLS.
312342|NCT01215422|O2|Outcome|Randomized to KS First|
312343|NCT01215422|O1|Outcome|Randomized to GS First|
312344|NCT01215422|O3|Outcome|Baseline Intubation Participants|Children intubated with the standard laryngoscope of the anesthesiologist's choice
312345|NCT01215422|O2|Outcome|KS Intubation Participants|Children successfully intubated with the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope (VLS)
312346|NCT01215422|O1|Outcome|GS Intubation Participants|Children successfully intubated with the GlideScope system (GS) video laryngoscope (VLS)
312347|NCT01215422|O4|Outcome|KS Intubation Times for Those Who Used GS First|
312348|NCT01215422|O3|Outcome|GS Intubation Times for Those Who Used KS First|
312349|NCT01215422|O2|Outcome|KS Intubation Times for Those Who Used KS First|
312350|NCT01215422|O1|Outcome|GS Intubation Times for Those Who Used GS First|
312351|NCT01215422|O3|Outcome|Baseline Intubation Participants|Children intubated at baseline using the standard laryngoscope of the anesthesiologist's choice
312352|NCT01215422|O2|Outcome|KS Intubation Participants|Children intubated with the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope (VLS)
312353|NCT01215422|O1|Outcome|GS Intubation Participants|Children intubated with the GlideScope system (GS) video laryngoscope (VLS)
312354|NCT01215422|O2|Outcome|KS Intubations|Anesthesiologists who performed minimum 18 intubations with the KS VLS
312355|NCT01215422|O1|Outcome|GS Intubations|Anesthesiologists who performed minimum 18 intubations with the GS VLS.
312356|NCT01215422|E4|Reported Event|GS Intubaton Participants|Children intubated with the GlideScope system (GS) video laryngoscope (VLS)
312438|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312357|NCT01215422|E3|Reported Event|KS Intubation Participants|Children intubated with the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope (VLS)
312358|NCT01215422|E2|Reported Event|Baseline Intubation Participants|Children intubated at baseline using the standard laryngoscope blade of the anesthesiologist's choice
312359|NCT01215422|E1|Reported Event|Overall Anesthesiologists|Baseline intubation times were obtained on a convenience sample of 20 children using the standard laryngoscope blade of their choice. Then anesthesiologists were randomized to complete either 20 intubations with the GlideScope system (GS) video laryngoscope (VLS) or 20 with the Karl Storz Direct Coupled Interface DCI (KS) VLS first. Once they had intubated 20 children with the VLS to which they were randomized, they crossed over to use the alternate VLS for 20 intubations.
312360|NCT01215357|B1|Baseline|Ecopipam 50 or 100 mg, as Needed|Patients were instructed to take a 50 mg tablet of ecopipam when they had an urge to gamble. If no effect, then they could take a second 50 mg tablet. If still no effect, they were not permitted to take any more ecopipam.
312361|NCT01215357|P1|Participant Flow|Ecopipam (50 or 100 mg, as Needed)|Patients were instructed to take a 50 mg tablet each time they had an urge to gamble. If that was ineffective, they were instructed to take a second 50 mg tablet. If that was ineffective, they were not allowed to increase the dose further.
312362|NCT01215357|O1|Outcome|Ecopipam 50 mg or 100 mg as Needed|Patients were instructed to take one 50 mg tablet of ecopipam when they had an urge to gamble. If this was effective, they should not take any more drug. If it was not effective, they were permitted to take a second 50 mg tablet of ecopipam. If this was effective, they should not take any more drug. If this was not effective, they were not permitted to take any additional ecopipam.
312363|NCT01215357|E1|Reported Event|Ecopipam 50 or 100 mg, as Needed|Patients were instructed to take a 50 mg tablet of ecopipam when they had an urge to gamble. If no effect, then they could take a second 50 mg tablet. If still no effect, they were not permitted to take any more ecopipam.
312364|NCT01215344|B3|Baseline|Total|Total of all reporting groups
312365|NCT01215344|B2|Baseline|VDD (VELCADE, Liposomal Doxorubicin, Dexamethasone)|"VELCADE, liposomal doxorubicin, dexamethasone~VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle~DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice~Liposomal doxorubicin: 30 mg/m2 on day 4 of each cycle~Dexamethasone: 40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4"
312366|NCT01215344|B1|Baseline|VRD (VELCADE, Lenalidomide, Dexamethasone)|"VELCADE, Lenalidomide, Dexamethasone~VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle~Lenalidomide: 25 mg by mouth on days 1-4 of each cycle~Dexamethasone: 20 mg the day before and the day after receiving VELCADE~DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice~Bisphosphonates: Zoledronic acid by IB or pamidronate by IV can be used as per standard of care."
312367|NCT01215344|P2|Participant Flow|VDD (VELCADE, Liposomal Doxorubicin, Dexamethasone)|"VELCADE, liposomal doxorubicin, dexamethasone~VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle~DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice~Liposomal doxorubicin: 30 mg/m2 on day 4 of each cycle~Dexamethasone: 40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4"
312368|NCT01215344|P1|Participant Flow|VRD (VELCADE, Lenalidomide, Dexamethasone)|"VELCADE, Lenalidomide, Dexamethasone~VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle~Lenalidomide: 25 mg by mouth on days 1-4 of each cycle~Dexamethasone: 20 mg the day before and the day after receiving VELCADE~DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice~Bisphosphonates: Zoledronic acid by IB or pamidronate by IV can be used as per standard of care."
312369|NCT01215344|O2|Outcome|MRD Status Positive at Day 100 (Post-AHCT)|Patients with MRD status stay positive at both EOI and day 100.
312370|NCT01215344|O1|Outcome|MRD Negative at Day 100|Patients with MRD status negative at day 100 (post-AHCT). They have MRD negative or positve at EOI.
312371|NCT01215344|O2|Outcome|VELCADE, Liposomal Doxorubicin, Dexamethasone (VDD)|"VELCADE, liposomal doxorubicin, dexamethasone~VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle~DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice~Liposomal doxorubicin: 30 mg/m2 on day 4 of each cycle~Dexamethasone: 40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4"
312372|NCT01215344|O1|Outcome|VELCADE, Lenalidomide, Dexamethasone (VRD)|"VELCADE, Lenalidomide, Dexamethasone~VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle~Lenalidomide: 25 mg by mouth on days 1-4 of each cycle~Dexamethasone: 20 mg the day before and the day after receiving VELCADE~DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice~Bisphosphonates: Zoledronic acid by IB or pamidronate by IV can be used as per standard of care."
312373|NCT01215344|E2|Reported Event|VDD (VELCADE, Liposomal Doxorubicin, Dexamethasone)|"VELCADE, liposomal doxorubicin, dexamethasone~VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle~DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice~Liposomal doxorubicin: 30 mg/m2 on day 4 of each cycle~Dexamethasone: 40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4"
312374|NCT01215344|E1|Reported Event|VRD (VELCADE, Lenalidomide, Dexamethasone)|"VELCADE, Lenalidomide, Dexamethasone~VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle~Lenalidomide: 25 mg by mouth on days 1-4 of each cycle~Dexamethasone: 20 mg the day before and the day after receiving VELCADE~DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice~Bisphosphonates: Zoledronic acid by IB or pamidronate by IV can be used as per standard of care."
312375|NCT01215292|B6|Baseline|Total|Total of all reporting groups
312376|NCT01215292|B5|Baseline|Group 5: Anastrazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + anastrazole 1 mg PO 1x daily, Days 3-10
312377|NCT01215292|B4|Baseline|Acyline & T Gel & Ketoconazole 800|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + ketoconazole 800mg PO 1x daily, Days 3-10
312378|NCT01215292|B3|Baseline|Acyline & T Gel & Placebo Ketoconazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel (T gel) 5 gm daily Days 1-10, + placebo tab PO 1x daily, Day 3-10
312379|NCT01215292|B2|Baseline|Acyline & T Gel & Dutasteride|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + dutasteride 2.5 mg PO 1x daily, Days 3-10
312380|NCT01215292|B1|Baseline|Acyline & T Gel & Ketoconazole 400|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Days 1-10, + ketoconazole 400mg PO 1x daily, Days 3-10
312381|NCT01215292|P5|Participant Flow|Group 5: Anastrazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + anastrazole 1 mg PO 1x daily, Days 3-10
312382|NCT01215292|P4|Participant Flow|Acyline & T Gel & Ketoconazole 800|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + ketoconazole 800mg PO 1x daily, Days 3-10
312383|NCT01215292|P3|Participant Flow|Acyline & T Gel & Placebo Ketoconazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel (T gel) 5 gm daily Days 1-10, + placebo tab PO 1x daily, Day 3-10
312384|NCT01215292|P2|Participant Flow|Acyline & T Gel & Dutasteride|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + dutasteride 2.5 mg PO 1x daily, Days 3-10
312385|NCT01215292|P1|Participant Flow|Acyline & T Gel & Ketoconazole 400|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Days 1-10, + ketoconazole 400mg PO 1x daily, Days 3-10
312386|NCT01215292|O5|Outcome|Acyline & TGel & Anastrazole 1mg|
312387|NCT01215292|O4|Outcome|Acyline & TGel & Dutasteride 2.5mg|
312388|NCT01215292|O3|Outcome|Acyline + Tgel + Ketoconazole 800mg|Acyline injection 300 mcg/kg SC (day 1) + Testosterone gel 5g + ketoconazole
312389|NCT01215292|O2|Outcome|Acyline + Tgel + Ketoconazole 400mg|Acyline injection 300 mcg/kg SC (day 1) + Testosterone gel 5g + ketoconazole
312390|NCT01215292|O1|Outcome|Acyline + Testosterone Gel (Tgel)+ Placebo|
312391|NCT01215292|O5|Outcome|Acyline & TGel & Anastrazole|Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + Anastrazole 1mg x 7 days
312392|NCT01215292|O4|Outcome|Acyline & TGel & Dutasteride|Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + dutasteride 2.5mg x 7 days
312393|NCT01215292|O3|Outcome|Acyline & TGel & Ketoconazole 800 mg|Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + 800mg ketoconazole x 7 days
312394|NCT01215292|O2|Outcome|Acyline & TGel & Ketoconazole 400 mg|Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + ketoconazole 400mg x 7 days
312395|NCT01215292|O1|Outcome|Acyline + Testosterone Gel (Tgel)+ Placebo|Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + placebo
312396|NCT01215292|O5|Outcome|Acyline & TGel & Anastrazole 1mg|
312397|NCT01215292|O4|Outcome|Acyline & TGel & Dutasteride 2.5mg|
312398|NCT01215292|O3|Outcome|Acyline + Tgel + Ketoconazole 800mg|300mcg Acyline, 1% testosterone gel 5g daily + 800 mg ketoconazole
312399|NCT01215292|O2|Outcome|Acyline + Tgel + Ketoconazole 400mg|300mcg Acyline, 1% testosterone gel 5g daily + 400 mg ketoconazole
312400|NCT01215292|O1|Outcome|Acyline + Testosterone Gel + Placebo|300mcg Acyline, 1% testosterone gel 5g daily + placebo
312401|NCT01215292|E5|Reported Event|Group 5: Anastrazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + anastrazole 1 mg PO 1x daily, Days 3-10
312402|NCT01215292|E4|Reported Event|Acyline & T Gel & Ketoconazole 800|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + ketoconazole 800mg PO 1x daily, Days 3-10
312403|NCT01215292|E3|Reported Event|Acyline & T Gel & Placebo Ketoconazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel (T gel) 5 gm daily Days 1-10, + placebo tab PO 1x daily, Day 3-10
312404|NCT01215292|E2|Reported Event|Acyline & T Gel & Dutasteride|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + dutasteride 2.5 mg PO 1x daily, Days 3-10
312405|NCT01215292|E1|Reported Event|Acyline & T Gel & Ketoconazole 400|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Days 1-10, + ketoconazole 400mg PO 1x daily, Days 3-10
312406|NCT01215279|B3|Baseline|Total|Total of all reporting groups
312407|NCT01215279|B2|Baseline|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312408|NCT01215279|B1|Baseline|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312409|NCT01215279|P2|Participant Flow|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312410|NCT01215279|P1|Participant Flow|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312411|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312412|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312413|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312414|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312415|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312416|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312417|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312418|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312419|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312420|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312421|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312422|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312423|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312424|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312425|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312426|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312427|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312428|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312429|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312430|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312431|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312432|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312433|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312434|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312435|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312436|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312439|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312440|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312441|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312442|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312443|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312444|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312445|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312446|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312447|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312448|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312449|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312450|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312451|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312452|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312453|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312454|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312455|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312456|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312457|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312458|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312459|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312460|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312461|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312462|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312463|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312464|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312465|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312466|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312467|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312468|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312469|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312470|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312471|NCT01215279|E2|Reported Event|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
312472|NCT01215279|E1|Reported Event|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
312473|NCT01215227|B7|Baseline|Total|Total of all reporting groups
312474|NCT01215227|B6|Baseline|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
312475|NCT01215227|B5|Baseline|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
312476|NCT01215227|B4|Baseline|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312477|NCT01215227|B3|Baseline|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312478|NCT01215227|B2|Baseline|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312479|NCT01215227|B1|Baseline|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312480|NCT01215227|P6|Participant Flow|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
312481|NCT01215227|P5|Participant Flow|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
312556|NCT01215110|O5|Outcome|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
312557|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
312482|NCT01215227|P4|Participant Flow|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312483|NCT01215227|P3|Participant Flow|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312484|NCT01215227|P2|Participant Flow|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312485|NCT01215227|P1|Participant Flow|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312486|NCT01215227|O6|Outcome|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
312487|NCT01215227|O5|Outcome|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
312488|NCT01215227|O4|Outcome|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312489|NCT01215227|O3|Outcome|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312490|NCT01215227|O2|Outcome|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312491|NCT01215227|O1|Outcome|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312492|NCT01215227|O6|Outcome|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
312493|NCT01215227|O5|Outcome|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
312494|NCT01215227|O4|Outcome|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312495|NCT01215227|O3|Outcome|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312496|NCT01215227|O2|Outcome|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312497|NCT01215227|O1|Outcome|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312498|NCT01215227|O6|Outcome|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
312499|NCT01215227|O5|Outcome|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
312500|NCT01215227|O4|Outcome|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312558|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
312559|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
312501|NCT01215227|O3|Outcome|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312502|NCT01215227|O2|Outcome|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312503|NCT01215227|O1|Outcome|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312504|NCT01215227|O6|Outcome|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
312505|NCT01215227|O5|Outcome|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
312506|NCT01215227|O4|Outcome|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312507|NCT01215227|O3|Outcome|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312508|NCT01215227|O2|Outcome|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312509|NCT01215227|O1|Outcome|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312510|NCT01215227|O6|Outcome|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
312511|NCT01215227|O5|Outcome|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
312512|NCT01215227|O4|Outcome|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312513|NCT01215227|O3|Outcome|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312514|NCT01215227|O2|Outcome|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312515|NCT01215227|O1|Outcome|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312516|NCT01215227|O6|Outcome|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
312517|NCT01215227|O5|Outcome|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
312518|NCT01215227|O4|Outcome|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312519|NCT01215227|O3|Outcome|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312560|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
312561|NCT01215110|O5|Outcome|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
312520|NCT01215227|O2|Outcome|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312521|NCT01215227|O1|Outcome|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312522|NCT01215227|E6|Reported Event|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
312523|NCT01215227|E5|Reported Event|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
312524|NCT01215227|E4|Reported Event|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312525|NCT01215227|E3|Reported Event|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312526|NCT01215227|E2|Reported Event|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312527|NCT01215227|E1|Reported Event|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
312528|NCT01215123|B1|Baseline|Bevacizumab|Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
312529|NCT01215123|P1|Participant Flow|Bevacizumab|Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
312530|NCT01215123|O1|Outcome|Bevacizumab|Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
312531|NCT01215123|O1|Outcome|Bevacizumab|Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
312532|NCT01215123|E1|Reported Event|Bevacizumab|Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
312533|NCT01215110|B6|Baseline|Total|Total of all reporting groups
312534|NCT01215110|B5|Baseline|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
312535|NCT01215110|B4|Baseline|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
312536|NCT01215110|B3|Baseline|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
312537|NCT01215110|B2|Baseline|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
312538|NCT01215110|B1|Baseline|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
312539|NCT01215110|P5|Participant Flow|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
312540|NCT01215110|P4|Participant Flow|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; and 400 mg Days 3-14
312541|NCT01215110|P3|Participant Flow|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14
312542|NCT01215110|P2|Participant Flow|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14.
312543|NCT01215110|P1|Participant Flow|TMC207 100|TMC207- 200 mg Day 1; and 100 mg Days 2-14
312544|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; and 400 mg Days 3-14
312545|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14
312546|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14.
312547|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1; and 100 mg Days 2-14
312548|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; and 400 mg Days 3-14
312549|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14
312550|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14.
312551|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1; and 100 mg Days 2-14
312552|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; and 400 mg Days 3-14
312553|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14
312554|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14.
312555|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1; and 100 mg Days 2-14
312631|NCT01215097|O1|Outcome|Placebo|Placebo
312562|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
312563|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
312564|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
312565|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
312566|NCT01215110|O5|Outcome|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
312567|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
312568|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
312569|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
312570|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
312571|NCT01215110|O5|Outcome|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
312572|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
312573|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
312574|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
312575|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
312576|NCT01215110|O5|Outcome|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
312577|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
312578|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
312579|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
312580|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
312581|NCT01215110|O5|Outcome|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
312582|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
312583|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
312584|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
312585|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
312586|NCT01215110|O5|Outcome|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
312587|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
312588|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
312589|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
312590|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
312591|NCT01215110|O5|Outcome|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
312592|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
312593|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
312594|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
312595|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
312596|NCT01215110|E5|Reported Event|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
312597|NCT01215110|E4|Reported Event|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
312598|NCT01215110|E3|Reported Event|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
312599|NCT01215110|E2|Reported Event|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
312600|NCT01215110|E1|Reported Event|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
312601|NCT01215097|B3|Baseline|Total|Total of all reporting groups
312602|NCT01215097|B2|Baseline|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312603|NCT01215097|B1|Baseline|Placebo|Placebo
312604|NCT01215097|P2|Participant Flow|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312605|NCT01215097|P1|Participant Flow|Placebo|Placebo
312606|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312607|NCT01215097|O1|Outcome|Placebo|Placebo
312608|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312609|NCT01215097|O1|Outcome|Placebo|Placebo
312610|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312611|NCT01215097|O1|Outcome|Placebo|Placebo
312612|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312613|NCT01215097|O1|Outcome|Placebo|Placebo
312614|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312615|NCT01215097|O1|Outcome|Placebo|Placebo
312616|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312617|NCT01215097|O1|Outcome|Placebo|Placebo
312618|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312619|NCT01215097|O1|Outcome|Placebo|Placebo
312620|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312621|NCT01215097|O1|Outcome|Placebo|Placebo
312622|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312623|NCT01215097|O1|Outcome|Placebo|Placebo
312624|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312625|NCT01215097|O1|Outcome|Placebo|Placebo
312626|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312627|NCT01215097|O1|Outcome|Placebo|Placebo
312628|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312629|NCT01215097|O1|Outcome|Placebo|Placebo
312630|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312632|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312633|NCT01215097|O1|Outcome|Placebo|Placebo
312634|NCT01215097|E2|Reported Event|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312635|NCT01215097|E1|Reported Event|Placebo|Placebo
312636|NCT01215032|B1|Baseline|Metformin|"This is the only arm of this phase 2 open label study~Metformin: Taken orally twice daily each 28-day cycle"
312637|NCT01215032|P1|Participant Flow|Metformin|"This is the only arm of this phase 2 open label study~Metformin: Taken orally twice daily each 28-day cycle"
312638|NCT01215032|O2|Outcome|Abnormal Baseline Hemoglobin A1c|Hemoglobin A1c greater than or equal to 6.0 before metformin dosing began.
312639|NCT01215032|O1|Outcome|Normal Baseline Hemoglobin A1c|Hemoglobin A1c less than 6.0 before metformin dosing began.
312640|NCT01215032|O1|Outcome|Metformin|"This is the only arm of this phase 2 open label study~Metformin: Taken orally twice daily each 28-day cycle, for 12 cycles"
312641|NCT01215032|O1|Outcome|Metformin|"This is the only arm of this phase 2 open label study~Metformin: Taken orally twice daily each 28-day cycle, for 12 cycles"
312642|NCT01215032|O1|Outcome|Metformin|"This is the only arm of this phase 2 open label study~Metformin: Taken orally twice daily each 28-day cycle, for 12 cycles"
312643|NCT01215032|E1|Reported Event|Metformin|"This is the only arm of this phase 2 open label study~Metformin: Taken orally twice daily each 28-day cycle"
312644|NCT01214980|B3|Baseline|Total|Total of all reporting groups
312645|NCT01214980|B2|Baseline|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
312646|NCT01214980|B1|Baseline|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
312647|NCT01214980|P2|Participant Flow|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
312648|NCT01214980|P1|Participant Flow|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
312649|NCT01214980|O2|Outcome|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
312650|NCT01214980|O1|Outcome|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
312651|NCT01214980|O2|Outcome|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
312652|NCT01214980|O1|Outcome|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
312653|NCT01214980|O2|Outcome|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
312654|NCT01214980|O1|Outcome|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
312655|NCT01214980|O2|Outcome|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
312656|NCT01214980|O1|Outcome|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
312657|NCT01214980|O2|Outcome|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
312658|NCT01214980|O1|Outcome|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
312914|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312659|NCT01214980|E2|Reported Event|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
312660|NCT01214980|E1|Reported Event|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
312661|NCT01214915|B1|Baseline|Anagrelide Hydrochloride|
312662|NCT01214915|P1|Participant Flow|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day orally and titrated as necessary.
312663|NCT01214915|O1|Outcome|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day orally and titrated as necessary.
312664|NCT01214915|O1|Outcome|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day orally and titrated as necessary.
312665|NCT01214915|O1|Outcome|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day orally and titrated as necessary.
312666|NCT01214915|O1|Outcome|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day orally and titrated as necessary.
312667|NCT01214915|O1|Outcome|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day orally and titrated as necessary.
312668|NCT01214915|E1|Reported Event|Anagrelide Hydrochloride|
312669|NCT01214850|B4|Baseline|Total|Total of all reporting groups
312670|NCT01214850|B3|Baseline|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312671|NCT01214850|B2|Baseline|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
312672|NCT01214850|B1|Baseline|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
312673|NCT01214850|P3|Participant Flow|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312674|NCT01214850|P2|Participant Flow|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
312675|NCT01214850|P1|Participant Flow|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
312676|NCT01214850|O3|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312677|NCT01214850|O2|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
312678|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
312679|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart.
312680|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
312681|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart.
312682|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
312683|NCT01214850|O3|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312684|NCT01214850|O2|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
312685|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
312686|NCT01214850|O3|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312687|NCT01214850|O2|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
312688|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
312689|NCT01214850|O3|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312690|NCT01214850|O2|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
312691|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
312692|NCT01214850|O3|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312693|NCT01214850|O2|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
312694|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
312695|NCT01214850|O3|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312696|NCT01214850|O2|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
312697|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
312698|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312699|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
312700|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312701|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
312702|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312703|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
312704|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312705|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
312706|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312707|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
312708|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312709|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
312710|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312711|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
312712|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312713|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
312714|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312715|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
312716|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312717|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
312718|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312719|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
312720|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312721|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
312722|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312723|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
312724|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312725|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
312726|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312727|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
312728|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312729|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
312730|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312731|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
312732|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312733|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
312734|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312735|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
312736|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart.
312737|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
312738|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312739|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
312740|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312741|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
312742|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312743|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
312744|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312745|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
312746|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312747|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
312748|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312749|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
312750|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312751|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
312752|NCT01214850|E3|Reported Event|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
312753|NCT01214850|E2|Reported Event|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
312754|NCT01214850|E1|Reported Event|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
312755|NCT01214837|B4|Baseline|Total|Total of all reporting groups
312756|NCT01214837|B3|Baseline|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
312757|NCT01214837|B2|Baseline|MenACWY4|All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
312758|NCT01214837|B1|Baseline|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
312759|NCT01214837|P3|Participant Flow|Routine Vaccines|Subjects received routine vaccines only, including pneumococcal 13-valent conjugate vaccine (PCV-13), at 2, 4, 6 and 12 months of age.
312760|NCT01214837|P2|Participant Flow|MenACWY4|All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
312761|NCT01214837|P1|Participant Flow|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
312762|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
312763|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
312764|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
312765|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
312766|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
312767|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
312768|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
312769|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
312770|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
312771|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
312772|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
312773|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
312774|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
312775|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
312776|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
312777|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
312778|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
312779|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
312780|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
312781|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
312782|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
312783|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
312784|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
312785|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
312786|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
312787|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
312788|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
312907|NCT01214252|O1|Outcome|Permacol Patients|"Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.~Permacol Surgical Implant: Permacol Surgical Implant"
312789|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
312790|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
312791|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
312792|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
312793|NCT01214837|O1|Outcome|MenACWY4|All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
312794|NCT01214837|E3|Reported Event|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
312795|NCT01214837|E2|Reported Event|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
312796|NCT01214837|E1|Reported Event|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
312797|NCT01214824|B1|Baseline|Intervention Group|Participants using the FreeStyle Navigator System Intermittently
312798|NCT01214824|P1|Participant Flow|Intervention Group|Participants using the FreeStyle Navigator System Intermittently. At the start and end of the study subjects wore the FreeStyle Navigator masked (without seeing continuous glucose results) for 5 days (1 sensor wear). During the study subjects used the FreeStyle Navigator fully functional (unmasked) for 2 periods. The first unmasked phase was for 2 weeks (3 sensor wears) following the baseline masked wear. The second unmasked phase was a 5 day wear at 3 months. After each unmasked phase the HCP reviewed results with the subject and changes to insulin regimen were recommended as required. For the remainder of the study a standard blood glucose meter was used for diabetes management.
312799|NCT01214824|O1|Outcome|Intervention Group|Participants using the FreeStyle Navigator System Intermittently
312800|NCT01214824|O1|Outcome|Intervention Group|Participants using the FreeStyle Navigator System Intermittently
312801|NCT01214824|O1|Outcome|Intervention Group|Participants using the FreeStyle Navigator System intermittently
312802|NCT01214824|O1|Outcome|Intervention Group|Participants using the FreeStyle Navigator System Intermittently
312803|NCT01214824|E1|Reported Event|Intervention Group|Participants using the FreeStyle Navigator System Intermittently
312804|NCT01214811|B1|Baseline|Mepilex Border Ag|"Non comparative study with one active arm - Mepilex Border Ag~Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition."
312805|NCT01214811|P1|Participant Flow|Mepilex Border Ag|"Non comparative study with one active arm - Mepilex Border Ag~Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition."
312806|NCT01214811|O1|Outcome|Mepilex Border Ag|"Non comparative study with one active arm - Mepilex Border Ag~Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition."
312807|NCT01214811|E1|Reported Event|Mepilex Border Ag|"Non comparative study with one active arm - Mepilex Border Ag~Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition."
312808|NCT01214759|B1|Baseline|Truvada and Raltegravir|"Single arm~Truvada: Tenofovir 200mg/emtricitabine 300mg once a day~Raltegravir: Raltegravir 400mg twice a day"
312809|NCT01214759|P1|Participant Flow|Truvada and Raltegravir|"Single arm~Truvada: Tenofovir 200mg/emtricitabine 300mg once a day~Raltegravir: Raltegravir 400mg twice a day"
312810|NCT01214759|O1|Outcome|Truvada and Raltegravir|"Single arm~Truvada: Tenofovir 200mg/emtricitabine 300mg once a day~Raltegravir: Raltegravir 400mg twice a day"
312811|NCT01214759|O1|Outcome|Truvada and Raltegravir|"Single arm~Truvada: Tenofovir 200mg/emtricitabine 300mg once a day~Raltegravir: Raltegravir 400mg twice a day"
312812|NCT01214759|O1|Outcome|Truvada and Raltegravir|"Single arm~Truvada: Tenofovir 200mg/emtricitabine 300mg once a day~Raltegravir: Raltegravir 400mg twice a day"
312813|NCT01214759|E1|Reported Event|Truvada and Raltegravir|"Single arm~Truvada: Tenofovir 200mg/emtricitabine 300mg once a day~Raltegravir: Raltegravir 400mg twice a day"
312814|NCT01214720|B3|Baseline|Total|Total of all reporting groups
312815|NCT01214720|B2|Baseline|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
312816|NCT01214720|B1|Baseline|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
312817|NCT01214720|P2|Participant Flow|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
312915|NCT01214239|O1|Outcome|Placebo|Placebo
312916|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312818|NCT01214720|P1|Participant Flow|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 milligrams per kilogram (mg/kg) intravenously (IV) on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg per square meter (mg/m^2) IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, orally (PO), once daily (QD) for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
312819|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
312820|NCT01214720|O2|Outcome|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
312821|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
312822|NCT01214720|O2|Outcome|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
312823|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
312824|NCT01214720|O2|Outcome|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
312825|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
312826|NCT01214720|O2|Outcome|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
312827|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
312828|NCT01214720|O2|Outcome|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
312917|NCT01214239|O1|Outcome|Placebo|Placebo
312829|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
312830|NCT01214720|O2|Outcome|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
312831|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
312832|NCT01214720|E2|Reported Event|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
312833|NCT01214720|E1|Reported Event|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
312834|NCT01214616|B5|Baseline|Total|Total of all reporting groups
312835|NCT01214616|B4|Baseline|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
312836|NCT01214616|B3|Baseline|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
312837|NCT01214616|B2|Baseline|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
312838|NCT01214616|B1|Baseline|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
312839|NCT01214616|P4|Participant Flow|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
312840|NCT01214616|P3|Participant Flow|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
312841|NCT01214616|P2|Participant Flow|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
312842|NCT01214616|P1|Participant Flow|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
312843|NCT01214616|O4|Outcome|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
312844|NCT01214616|O3|Outcome|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
312845|NCT01214616|O2|Outcome|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
312846|NCT01214616|O1|Outcome|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
312847|NCT01214616|O4|Outcome|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
312848|NCT01214616|O3|Outcome|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
312849|NCT01214616|O2|Outcome|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
312850|NCT01214616|O1|Outcome|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
312908|NCT01214252|E1|Reported Event|Permacol Patients|Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.
312909|NCT01214239|B3|Baseline|Total|Total of all reporting groups
312974|NCT01214161|B3|Baseline|Total|Total of all reporting groups
312851|NCT01214616|O4|Outcome|Vinorelbine 25 mg/m^2 Without Afatinib|"Vinorelbine 25 mg/m^2 intravenous injection weekly without afatinib oral administration once a day.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
312852|NCT01214616|O3|Outcome|Vinorelbine 25 mg/m^2 With Afatinib|"Vinorelbine 25 mg/m^2 intravenous injection weekly with afatinib oral administration once a day.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
312853|NCT01214616|O2|Outcome|Vinorelbine 20 mg/m^2 Without Afatinib|"Vinorelbine 20 mg/m^2 intravenous injection weekly without afatinib oral administration once a day.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
312854|NCT01214616|O1|Outcome|Vinorelbine 20 mg/m^2 With Afatinib|"Vinorelbine 20 mg/m^2 intravenous injection weekly with afatinib oral administration once a day.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
312855|NCT01214616|O4|Outcome|Vinorelbine 25 mg/m^2 Without Afatinib|"Vinorelbine 25 mg/m^2 intravenous injection weekly without afatinib oral administration once a day.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
312856|NCT01214616|O3|Outcome|Vinorelbine 25 mg/m^2 With Afatinib|"Vinorelbine 25 mg/m^2 intravenous injection weekly with afatinib oral administration once a day.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
312857|NCT01214616|O2|Outcome|Vinorelbine 20 mg/m^2 Without Afatinib|"Vinorelbine 20 mg/m^2 intravenous injection weekly without afatinib oral administration once a day.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
312858|NCT01214616|O1|Outcome|Vinorelbine 20 mg/m^2 With Afatinib|"Vinorelbine 20 mg/m^2 intravenous injection weekly with afatinib oral administration once a day.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
312859|NCT01214616|O4|Outcome|Afatinib 40 mg Without Vinorelbine|"Afatinib 40 mg oral administration once a day without vinorelbine intravenous injection weekly.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
312860|NCT01214616|O3|Outcome|Afatinib 40 mg With Vinorelbine|"Afatinib 40 mg oral administration once a day with vinorelbine intravenous injection weekly.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
312861|NCT01214616|O2|Outcome|Afatinib 20 mg Without Vinorelbine|"Afatinib 20 mg oral administration once a day without vinorelbine intravenous injection weekly.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
312862|NCT01214616|O1|Outcome|Afatinib 20 mg With Vinorelbine|"Afatinib 20 mg oral administration once a day with vinorelbine intravenous injection weekly.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
312863|NCT01214616|O4|Outcome|Afatinib 40 mg Without Vinorelbine|"Afatinib 40 mg oral administration once a day without vinorelbine intravenous injection weekly.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
312864|NCT01214616|O3|Outcome|Afatinib 40 mg With Vinorelbine|"Afatinib 40 mg oral administration once a day with vinorelbine intravenous injection weekly.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
312910|NCT01214239|B2|Baseline|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312911|NCT01214239|B1|Baseline|Placebo|Placebo
312912|NCT01214239|P2|Participant Flow|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312913|NCT01214239|P1|Participant Flow|Placebo|Placebo
312865|NCT01214616|O2|Outcome|Afatinib 20 mg Without Vinorelbine|"Afatinib 20 mg oral administration once a day without vinorelbine intravenous injection weekly.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
312866|NCT01214616|O1|Outcome|Afatinib 20 mg With Vinorelbine|"Afatinib 20 mg oral administration once a day with vinorelbine intravenous injection weekly.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
312867|NCT01214616|O4|Outcome|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
312868|NCT01214616|O3|Outcome|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
312869|NCT01214616|O2|Outcome|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
312870|NCT01214616|O1|Outcome|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
312871|NCT01214616|E4|Reported Event|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
312872|NCT01214616|E3|Reported Event|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
312873|NCT01214616|E2|Reported Event|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
312874|NCT01214616|E1|Reported Event|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
312875|NCT01214434|B3|Baseline|Total|Total of all reporting groups
312876|NCT01214434|B2|Baseline|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
312877|NCT01214434|B1|Baseline|Bland Emollient|Bland emollient : Eucerin cream twice daily
312878|NCT01214434|P2|Participant Flow|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
312879|NCT01214434|P1|Participant Flow|Bland Emollient|Bland emollient : Eucerin cream twice daily
312880|NCT01214434|O2|Outcome|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
312881|NCT01214434|O1|Outcome|Bland Emollient|Bland emollient : Eucerin cream twice daily
312882|NCT01214434|O2|Outcome|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
312883|NCT01214434|O1|Outcome|Bland Emollient|Bland emollient : Eucerin cream twice daily
312884|NCT01214434|O2|Outcome|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
312885|NCT01214434|O1|Outcome|Bland Emollient|Bland emollient : Eucerin cream twice daily
312886|NCT01214434|O2|Outcome|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
312887|NCT01214434|O1|Outcome|Bland Emollient|Bland emollient : Eucerin cream twice daily
312888|NCT01214434|O2|Outcome|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
312889|NCT01214434|O1|Outcome|Bland Emollient|Bland emollient : Eucerin cream twice daily
312890|NCT01214434|O2|Outcome|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
312891|NCT01214434|O1|Outcome|Bland Emollient|Bland emollient : Eucerin cream twice daily
312892|NCT01214434|E2|Reported Event|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
312893|NCT01214434|E1|Reported Event|Bland Emollient|Bland emollient : Eucerin cream twice daily
312894|NCT01214395|B1|Baseline|Tea Tree Oil Application|tea tree oil medication group
312895|NCT01214395|P1|Participant Flow|Tea Tree Oil Application|tea tree oil medication group
312896|NCT01214395|O1|Outcome|Did Not Have Staph. Aureus Infection|No exit site infection or peritonitis with Staph. aureus
312897|NCT01214395|O1|Outcome|Tea Tree Oil|tea tree oil application
312898|NCT01214395|E1|Reported Event|Tea Tree Oil Application|tea tree oil medication group
312899|NCT01214330|B1|Baseline|Solopap|females, age >18, without severe hand arthritis
312900|NCT01214330|P1|Participant Flow|Self Pap Smear|"SoloPap: Patient-Collected Cervical Papanicolaou Smears~Self Pap Smear"
312901|NCT01214330|O1|Outcome|Self Pap Smear|"SoloPap: Patient-Collected Cervical Papanicolaou Smears~Self Pap Smear"
312902|NCT01214330|E1|Reported Event|Self Pap Smear|"SoloPap: Patient-Collected Cervical Papanicolaou Smears~Self Pap Smear"
312903|NCT01214252|B1|Baseline|Permacol Patients|Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.
312904|NCT01214252|P1|Participant Flow|Permacol Patients|Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.
312905|NCT01214252|O1|Outcome|Permacol Patients|"Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.~Permacol Surgical Implant: Permacol Surgical Implant"
312906|NCT01214252|O1|Outcome|Permacol Patients|"Total (confirmed or unconfrimed) hernia or hernia recurrence at the repair site by year (# and percentage).~Unconfirmed hernia or recurrence reported by the subject is defined by confirmation of hernia symptoms based on results of the Symptoms questionnaire but not confirmed by clinical assessment by a surgeon or medical chart review"
312918|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312919|NCT01214239|O1|Outcome|Placebo|Placebo
312920|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312921|NCT01214239|O1|Outcome|Placebo|Placebo
312922|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312923|NCT01214239|O1|Outcome|Placebo|Placebo
312924|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312925|NCT01214239|O1|Outcome|Placebo|Placebo
312926|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312927|NCT01214239|O1|Outcome|Placebo|Placebo
312928|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312929|NCT01214239|O1|Outcome|Placebo|Placebo
312930|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312931|NCT01214239|O1|Outcome|Placebo|Placebo
312932|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312933|NCT01214239|O1|Outcome|Placebo|Placebo
312934|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312935|NCT01214239|O1|Outcome|Placebo|Placebo
312936|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312937|NCT01214239|O1|Outcome|Placebo|Placebo
312938|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312939|NCT01214239|O1|Outcome|Placebo|Placebo
312940|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312941|NCT01214239|O1|Outcome|Placebo|Placebo
312942|NCT01214239|E2|Reported Event|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
312943|NCT01214239|E1|Reported Event|Placebo|Placebo
312944|NCT01214187|B3|Baseline|Total|Total of all reporting groups
312945|NCT01214187|B2|Baseline|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
312946|NCT01214187|B1|Baseline|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.~inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
312947|NCT01214187|P2|Participant Flow|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
312948|NCT01214187|P1|Participant Flow|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.~inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
312949|NCT01214187|O2|Outcome|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
312950|NCT01214187|O1|Outcome|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.~inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
312951|NCT01214187|O2|Outcome|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
312952|NCT01214187|O1|Outcome|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.~inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
312953|NCT01214187|O2|Outcome|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
312954|NCT01214187|O1|Outcome|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.~inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
312955|NCT01214187|O2|Outcome|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
312956|NCT01214187|O1|Outcome|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.~inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
312957|NCT01214187|O2|Outcome|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
312958|NCT01214187|O1|Outcome|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.~inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
312959|NCT01214187|E2|Reported Event|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
312960|NCT01214187|E1|Reported Event|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.~inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
312961|NCT01214174|B4|Baseline|Total|Total of all reporting groups
312962|NCT01214174|B3|Baseline|Dose 3|IBI-10090 1046ug
312963|NCT01214174|B2|Baseline|Dose 2|IBI-10090 776ug
312964|NCT01214174|B1|Baseline|Dose 1|IBI-10090 513ug
312965|NCT01214174|P3|Participant Flow|Dose 3|IBI-10090 1046ug
312966|NCT01214174|P2|Participant Flow|Dose 2|IBI-10090 776ug
312967|NCT01214174|P1|Participant Flow|Dose 1|IBI-10090 513ug
312968|NCT01214174|O3|Outcome|Dose 3|IBI-10090 1046ug
312969|NCT01214174|O2|Outcome|Dose 2|IBI-10090 776ug
312970|NCT01214174|O1|Outcome|Dose 1|IBI-10090 513ug
312971|NCT01214174|E3|Reported Event|Dose 3|IBI-10090 1046ug
312972|NCT01214174|E2|Reported Event|Dose 2|IBI-10090 776ug
312973|NCT01214174|E1|Reported Event|Dose 1|IBI-10090 513ug
312975|NCT01214161|B2|Baseline|Placebo Gel (Surgilube)|"This group will be randomized to having the intervention with the placebo surgilube gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
312976|NCT01214161|B1|Baseline|Lidocaine Gel|"This group will be those randomized to receiving the intervention with 2% lidocaine gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
312977|NCT01214161|P2|Participant Flow|Placebo Gel (Surgilube)|"This group will be randomized to having the intervention with the placebo surgilube gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
312978|NCT01214161|P1|Participant Flow|Lidocaine Gel|"This group will be those randomized to receiving the intervention with 2% lidocaine gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
312979|NCT01214161|O2|Outcome|Providers|The healthcare provider placing the IUD on that particular participant.
312980|NCT01214161|O1|Outcome|Participants|The cohort of all 200 women having their IUD inserted.
312981|NCT01214161|O2|Outcome|Placebo Gel (Surgilube)|"This group will be randomized to having the intervention with the placebo surgilube gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
312982|NCT01214161|O1|Outcome|Lidocaine Gel|"This group will be those randomized to receiving the intervention with 2% lidocaine gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
312983|NCT01214161|O2|Outcome|Placebo Gel (Surgilube)|"This group will be randomized to having the intervention with the placebo surgilube gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
312984|NCT01214161|O1|Outcome|Lidocaine Gel|"This group will be those randomized to receiving the intervention with 2% lidocaine gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
313027|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313028|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313029|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313030|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313031|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
312985|NCT01214161|E2|Reported Event|Placebo Gel (Surgilube)|"This group will be randomized to having the intervention with the placebo surgilube gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
312986|NCT01214161|E1|Reported Event|Lidocaine Gel|"This group will be those randomized to receiving the intervention with 2% lidocaine gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
312987|NCT01214109|B1|Baseline|All Subjects|24 subjects were equally randomised to one of two groups / sequences, and in general terms, ABCD or BADC. Hence, 12 subjects were in group ABCD and 12 in BADC. All 24 subjects received all treatments, A, B, C, D. The numbers presented are by overall treatment.
312988|NCT01214109|P4|Participant Flow|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
312989|NCT01214109|P3|Participant Flow|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
312990|NCT01214109|P2|Participant Flow|0.125 mg t.i.d. Immediate Release (IR)|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
312991|NCT01214109|P1|Participant Flow|0.375 mg q.d.Extended Release (ER)|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
312992|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
312993|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
312994|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
312995|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
312996|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
312997|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
312998|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
312999|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313000|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313001|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313002|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313003|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313004|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313005|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313006|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313007|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313008|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313009|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313010|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313011|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313012|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313013|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313014|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313015|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313016|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313017|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313018|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313019|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313020|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313021|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313022|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313023|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313024|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313025|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313026|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313032|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313033|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313034|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313035|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313036|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313037|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313038|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313039|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313040|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313041|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313042|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313043|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313044|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313045|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313046|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313047|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313048|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313049|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313050|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313051|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313052|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313053|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313054|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313055|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313056|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313057|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313058|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313059|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313060|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313061|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313062|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313063|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313064|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313065|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313066|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313067|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313068|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313069|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313070|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313071|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313072|NCT01214109|E7|Reported Event|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313073|NCT01214109|E6|Reported Event|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
313074|NCT01214109|E5|Reported Event|0.375 mg q.d.ER Down-titration|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313075|NCT01214109|E4|Reported Event|0.75 mg q.d. ER Down-titration|0.75mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313076|NCT01214109|E3|Reported Event|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313077|NCT01214109|E2|Reported Event|0.75 mg q.d. ER Up-titration|0.75mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313078|NCT01214109|E1|Reported Event|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
313079|NCT01214083|B4|Baseline|Total|Total of all reporting groups
313080|NCT01214083|B3|Baseline|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
313081|NCT01214083|B2|Baseline|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
313082|NCT01214083|B1|Baseline|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
313083|NCT01214083|P3|Participant Flow|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
313084|NCT01214083|P2|Participant Flow|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
313085|NCT01214083|P1|Participant Flow|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
313086|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
313087|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
313088|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
313089|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
313090|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
313091|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
313092|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
313093|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
313094|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
313095|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
313096|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
313097|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
313098|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
313099|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
313100|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
313101|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
313102|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
313103|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
313104|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
313105|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
313106|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
313107|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
313108|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
313109|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
313110|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
313111|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
313112|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
313113|NCT01214083|E3|Reported Event|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
313114|NCT01214083|E2|Reported Event|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
313115|NCT01214083|E1|Reported Event|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
313116|NCT01213966|B5|Baseline|Total|Total of all reporting groups
313117|NCT01213966|B4|Baseline|Cohort 4 - OZ439 1200mg|1200 mg OZ439 po single dose
313118|NCT01213966|B3|Baseline|Cohort 3 - OZ439 200mg|200mg OZ439 p.o. single dose
313119|NCT01213966|B2|Baseline|Cohort 2 - OZ439 400mg|400 mg OZ439 p.o. single dose
313120|NCT01213966|B1|Baseline|Cohort 1 - OZ439 800mg|800 mg OZ439 po single dose
313121|NCT01213966|P4|Participant Flow|1200 mg OZ439 po Single Dose|Ultimately, after review of the data from Cohort 1 (800 mg), patients in Cohort 2 received 400 mg OZ439, patients in Cohort 3 received 200 mg OZ439, and patients in Cohort 4 received 1200 mg OZ439.received single dose
313122|NCT01213966|P3|Participant Flow|200mg OZ439 p.o. Single Dose|Ultimately, after review of the data from Cohort 1 (800 mg), patients in Cohort 2 received 400 mg OZ439, patients in Cohort 3 received 200 mg OZ439, and patients in Cohort 4 received 1200 mg OZ439.
313123|NCT01213966|P2|Participant Flow|400 mg OZ439 p.o. Single Dose|Ultimately, after review of the data from Cohort 1 (800 mg), patients in Cohort 2 received 400 mg OZ439, patients in Cohort 3 received 200 mg OZ439, and patients in Cohort 4 received 1200 mg OZ439.
313124|NCT01213966|P1|Participant Flow|800 mg OZ439 po Single Dose|Cohort 1 received a dose of 800 mg. The decision to decrease and/or increase the dose (within a 100 mg to 1600 mg range) in each next cohort of patients was made following a study cohort review
313213|NCT01213576|O4|Outcome|Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually|"Twice a year~Albendazole 800mg and ivermectin 400mcg/kg given twice a year"
313125|NCT01213966|O4|Outcome|1200 mg OZ439 po Single Dose|"Ultimately, after review of the data from Cohort 1 (800 mg), from Cohort 2 (400 mg), and Cohort 3 (200 mg), patients in Cohort 4 received a single dose of 1200 mg OZ439.~It was decided not to proceed with a fifth cohort and no further patients were enrolled."
313126|NCT01213966|O3|Outcome|200mg OZ439 p.o. Single Dose|Ultimately, after review of the data from Cohort 1 (800 mg) and data from Cohort 2 (400 mg), patients in Cohort 3 received a single dose of 200 mg OZ439.
313127|NCT01213966|O2|Outcome|400 mg OZ439 p.o. Single Dose|After review of the data from Cohort 1 (800 mg), patients in Cohort 2 received a single dose of 400 mg OZ439.
313128|NCT01213966|O1|Outcome|800 mg OZ439 po Single Dose|The first cohort received a dose of 800 mg. The decision to decrease and/or increase the dose (within a 100 mg to 1600 mg range) in each next cohort of patients with either P. falciparum or P. vivax malaria, was made following a study cohort review of the safety data, drug exposure levels, and the PRR over 24 hours after the investigational product administration (PRR24) obtained from the previous cohort.
313129|NCT01213966|E4|Reported Event|Cohort 4 - OZ439 1200mg|1200 mg OZ439 po single dose
313130|NCT01213966|E3|Reported Event|Cohort 3 - OZ439 200mg|200mg OZ439 p.o. single dose
313131|NCT01213966|E2|Reported Event|Cohort 2 - OZ439 400mg|400 mg OZ439 p.o. single dose
313132|NCT01213966|E1|Reported Event|Cohort 1 - OZ439 800mg|800 mg OZ439 po single dose
313133|NCT01213836|B3|Baseline|Total|Total of all reporting groups
313134|NCT01213836|B2|Baseline|First Seroquel IR Then Seroquel XR|Patients randomised to Seroquel IR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel XR for 10-16 days
313135|NCT01213836|B1|Baseline|First Seroquel XR Then Seroquel IR|Patients randomised to Seroquel XR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel IR for 10-16 days
313136|NCT01213836|P2|Participant Flow|First Seroquel IR Then Seroquel XR|Patients randomised to Seroquel IR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel XR for 10-16 days
313137|NCT01213836|P1|Participant Flow|First Seroquel XR Then Seroquel IR|Patients randomised to Seroquel XR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel IR for 10-16 days
313138|NCT01213836|O2|Outcome|Seroquel IR|Patients that took Seroquel IR in arm XR-IR and arm IR-XR.
313139|NCT01213836|O1|Outcome|Seroquel XR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
313140|NCT01213836|O2|Outcome|Seroquel IR|Patients treated with at least one dose of Seroquel IR
313141|NCT01213836|O1|Outcome|Seroquel XR|Patients treated with at least one dose of Seroquel XR
313142|NCT01213836|O2|Outcome|Seroquel IR|Patients that took Seroquel IR in arm XR-IR and arm IR-XR.
313143|NCT01213836|O1|Outcome|Seroquel XR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
313144|NCT01213836|O2|Outcome|Seroquel IR|Patients that took Seroquel IR in arm XR-IR and arm IR-XR.
313145|NCT01213836|O1|Outcome|Seroquel XR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
313146|NCT01213836|O2|Outcome|Seroquel IR|Patients that took Seroquel IR in arm XR-IR and arm IR-XR.
313147|NCT01213836|O1|Outcome|Seroquel XR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
313148|NCT01213836|O2|Outcome|Seroquel IR|Patients that took Seroquel IR in arm XR-IR and arm IR-XR.
313149|NCT01213836|O1|Outcome|Seroquel XR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
313150|NCT01213836|O2|Outcome|Seroquel IR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
313151|NCT01213836|O1|Outcome|Seroquel XR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
313152|NCT01213836|E2|Reported Event|Seroquel IR|Patients treated with at least one dose of Seroquel IR
313153|NCT01213836|E1|Reported Event|Seroquel XR|Patients treated with at least one dose of Seroquel XR
313154|NCT01213823|B3|Baseline|Total|Total of all reporting groups
313155|NCT01213823|B2|Baseline|Controls|Controls were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) without a diagnosis of severe hepatic injury.
313156|NCT01213823|B1|Baseline|Cases|Potential cases were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) with severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified into one of the following categories: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [xULN] and total bilirubin >2 xULN, with absence of alkaline phosphatase elevation; 3) serum ALT levels greater than or equal to (≥)10 xULN; 4) ALT levels >3 xULN and less than (<)10 xULN; or 5) as determined by clinician.
313157|NCT01213823|P2|Participant Flow|Controls|Controls were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) without a diagnosis of severe hepatic injury.
313158|NCT01213823|P1|Participant Flow|Cases|Potential cases were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) with severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified into one of the following categories: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [xULN] and total bilirubin >2 xULN, with absence of alkaline phosphatase elevation; 3) serum ALT levels greater than or equal to (≥)10 xULN; 4) ALT levels >3 xULN and less than (<)10 xULN; or 5) as determined by clinician.
313159|NCT01213823|O2|Outcome|Controls|Controls were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) without a diagnosis of severe hepatic injury.
313214|NCT01213576|O3|Outcome|Albendazole 400mg and Ivermectin 200mcg/kg Biannually|"Twice a year~albendazole 400mg and ivermectin 200mcg/kg given twice a year"
313160|NCT01213823|O1|Outcome|Cases|Potential cases were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) with severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified into one of the following categories: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [xULN] and total bilirubin >2 xULN, with absence of alkaline phosphatase elevation; 3) serum ALT levels greater than or equal to (≥)10 xULN; 4) ALT levels >3 xULN and less than (<)10 xULN; or 5) as determined by clinician.
313161|NCT01213823|E2|Reported Event|Controls|Controls were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) without a diagnosis of severe hepatic injury.
313162|NCT01213823|E1|Reported Event|Cases|Potential cases were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) with severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified into one of the following categories: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [xULN] and total bilirubin >2 xULN, with absence of alkaline phosphatase elevation; 3) serum ALT levels greater than or equal to (≥)10 xULN; 4) ALT levels >3 xULN and less than (<)10 xULN; or 5) as determined by clinician.
313163|NCT01213706|B1|Baseline|Whole Body Periodic Acceleration (WBPA)|"Whole Body Periodic Acceleration (WBPA) in spinal axis (pGz) will be administered with a platform that resembles a bed. The platform moves in a repetitive head-to-foot direction at 140 times a minute, producing 0.22 g. These settings have been shown to release NO into the circulation.~Whole Body Periodic Acceleration (WBPA): Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min."
313164|NCT01213706|P1|Participant Flow|SHAM WBPA Then WBPA|
313165|NCT01213706|O2|Outcome|Sham WBPA|Subjects will be resting on the platform without any WBPA.
313166|NCT01213706|O1|Outcome|WBPA|Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min.
313167|NCT01213706|E2|Reported Event|Sham WBPA|"The subjects will rest for 45 minutes in the Whole Body Periodic Acceleration (WBPA) platform without movement as a control challenge.~Sham WBPA: The subjects will rest for 45 minutes in the Whole Body Periodic Acceleration (WBPA) platform without movement as a control challenge."
313168|NCT01213706|E1|Reported Event|Whole Body Periodic Acceleration (WBPA)|"Whole Body Periodic Acceleration (WBPA) in spinal axis (pGz) will be administered with a platform that resembles a bed. The platform moves in a repetitive head-to-foot direction at 140 times a minute, producing 0.22 g. These settings have been shown to release NO into the circulation.~Whole Body Periodic Acceleration (WBPA): Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min."
313169|NCT01213589|B4|Baseline|Total|Total of all reporting groups
313170|NCT01213589|B3|Baseline|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
313171|NCT01213589|B2|Baseline|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
313172|NCT01213589|B1|Baseline|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
313173|NCT01213589|P3|Participant Flow|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
313174|NCT01213589|P2|Participant Flow|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
313175|NCT01213589|P1|Participant Flow|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
313176|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
313177|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
313178|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
313179|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
313180|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
313181|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
313215|NCT01213576|O2|Outcome|Albendazole 800mg and Ivermectin 400mcg/kg Annually|"Once a year treatment~Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral"
313182|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
313183|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
313184|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
313185|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
313186|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
313187|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
313188|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
313189|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
313190|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
313191|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
313192|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
313193|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
313194|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
313195|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
313196|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
313197|NCT01213589|E3|Reported Event|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
313198|NCT01213589|E2|Reported Event|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
313199|NCT01213589|E1|Reported Event|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
313200|NCT01213576|B5|Baseline|Total|Total of all reporting groups
313201|NCT01213576|B4|Baseline|Albendazole 800mg and Ivermectin 400mcg/kg Bi-annual|Albendazole 800mg and ivermectin 400mcg/kg given twice a year
313202|NCT01213576|B3|Baseline|Albendazole 400mg and Ivermectin 200mcg/kg Biannual|Albendazole 400mg and ivermectin 200mcg/kg given twice a year
313203|NCT01213576|B2|Baseline|Albendazole 800mg and Ivermectin 400mcg/kg Annual|Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg orally given once a year
313204|NCT01213576|B1|Baseline|Albendazole 400mg and Ivermectin 200mcg/kg Annual|Albendazole 400mg and ivermectin 200mcg/kg: 400 mg orally given once a year
313205|NCT01213576|P4|Participant Flow|Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually|"Twice a year~Albendazole 800mg and ivermectin 400mcg/kg given twice a year"
313206|NCT01213576|P3|Participant Flow|Albendazole 400mg and Ivermectin 200mcg/kg Biannually|"Twice a year~albendazole 400mg and ivermectin 200mcg/kg given twice a year"
313207|NCT01213576|P2|Participant Flow|Albendazole 800mg and Ivermectin 400mcg/kg Annually|"Once a year treatment~Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral"
313208|NCT01213576|P1|Participant Flow|Albendazole 400mg and Ivermectin 200mcg/kg Annually|"Once a year treatment~Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral"
313209|NCT01213576|O4|Outcome|Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually|"Twice a year~Albendazole 800mg and ivermectin 400mcg/kg given twice a year"
313210|NCT01213576|O3|Outcome|Albendazole 400mg and Ivermectin 200mcg/kg Biannually|"Twice a year~albendazole 400mg and ivermectin 200mcg/kg given twice a year"
313211|NCT01213576|O2|Outcome|Albendazole 800mg and Ivermectin 400mcg/kg Annually|"Once a year treatment~Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral"
313212|NCT01213576|O1|Outcome|Albendazole 400mg and Ivermectin 200mcg/kg Annually|"Once a year treatment~Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral"
313290|NCT01213251|O1|Outcome|Pooled Pacing|Subjects successfully implanted with a CRT-D device (either single or dual pacing).
313216|NCT01213576|O1|Outcome|Albendazole 400mg and Ivermectin 200mcg/kg Annually|"Once a year treatment~Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral"
313217|NCT01213576|E4|Reported Event|Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually|"Twice a year~Albendazole 800mg and ivermectin 400mcg/kg given twice a year"
313218|NCT01213576|E3|Reported Event|Albendazole 400mg and Ivermectin 200mcg/kg Biannually|"Twice a year~albendazole 400mg and ivermectin 200mcg/kg given twice a year"
313219|NCT01213576|E2|Reported Event|Albendazole 800mg and Ivermectin 400mcg/kg Annually|"Once a year treatment~Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral"
313220|NCT01213576|E1|Reported Event|Albendazole 400mg and Ivermectin 200mcg/kg Annually|"Once a year treatment~Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral"
313221|NCT01213329|B3|Baseline|Total|Total of all reporting groups
313222|NCT01213329|B2|Baseline|Donor Comparison|
313223|NCT01213329|B1|Baseline|Alemtuzumab (Phase I)|"All transplant recipients received one 30mg dose (intravenous IV push)of Alemtuzmab in the operating room per Standard of Care."
313224|NCT01213329|P2|Participant Flow|Donor Comparison|
313225|NCT01213329|P1|Participant Flow|Alemtuzumab (Phase I)|"All transplant recipients received one 30mg dose (intravenous IV push)of Alemtuzmab in the operating room per Standard of Care."
313226|NCT01213329|O2|Outcome|Donor Comparison|
313227|NCT01213329|O1|Outcome|Alemtuzumab (Phase I)|"All transplant recipients received one 30mg dose (intravenous IV push)of Alemtuzmab in the operating room per Standard of Care."
313228|NCT01213329|E2|Reported Event|Donor Comparison|
313229|NCT01213329|E1|Reported Event|Alemtuzumab (Phase I)|"All transplant recipients received one 30mg dose (intravenous IV push)of Alemtuzmab in the operating room per Standard of Care."
313230|NCT01213316|B1|Baseline|Overall Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
313231|NCT01213316|P1|Participant Flow|Overall Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
313232|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
313233|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
313234|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
313235|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
313236|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
313237|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
313238|NCT01213316|O1|Outcome|Initial Cohort Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks in combination with other antiretroviral drugs under conditions representative of standard clinical practice for HIV-1 patients in Germany.
313239|NCT01213316|O1|Outcome|Initial Cohort Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks in combination with other antiretroviral drugs under conditions representative of standard clinical practice for HIV-1 patients in Germany.
313240|NCT01213316|O1|Outcome|Initial Cohort Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks in combination with other antiretroviral drugs under conditions representative of standard clinical practice for HIV-1 patients in Germany.
313241|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
313242|NCT01213316|O1|Outcome|Overall Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
313243|NCT01213316|E3|Reported Event|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
313244|NCT01213316|E2|Reported Event|Initial Cohort Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
313291|NCT01213251|E3|Reported Event|Control|Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management.
313245|NCT01213316|E1|Reported Event|Overall Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
313246|NCT01213264|B4|Baseline|Total|Total of all reporting groups
313247|NCT01213264|B3|Baseline|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
313248|NCT01213264|B2|Baseline|Sugammadex|Participants administered sugammadex for NMB reversal
313249|NCT01213264|B1|Baseline|Spontaneous Reversal|Participants whose reversal from NMB was spontaneous (no reversal agent used)
313250|NCT01213264|P3|Participant Flow|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
313251|NCT01213264|P2|Participant Flow|Sugammadex|Participants administered sugammadex for NMB reversal
313252|NCT01213264|P1|Participant Flow|Spontaneous Reversal|Participants whose reversal from neuromuscular blockade (NMB) was spontaneous (no reversal agent used)
313253|NCT01213264|O1|Outcome|Total Study Population|Total population of study participants who received an NMBA or NMB-reversal agent
313254|NCT01213264|O2|Outcome|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
313255|NCT01213264|O1|Outcome|Sugammadex|Participants administered sugammadex for NMB reversal
313256|NCT01213264|O2|Outcome|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
313257|NCT01213264|O1|Outcome|Sugammadex|Participants administered sugammadex for NMB reversal
313258|NCT01213264|O1|Outcome|Total Study Population|Total population of study participants who received an NMBA or NMB-reversal agent
313259|NCT01213264|O3|Outcome|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
313260|NCT01213264|O2|Outcome|Sugammadex|Participants administered sugammadex for NMB reversal
313261|NCT01213264|O1|Outcome|Spontaneous Reversal|Participants whose reversal from NMB was spontaneous (no reversal agent used)
313262|NCT01213264|O3|Outcome|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
313263|NCT01213264|O2|Outcome|Sugammadex|Participants administered sugammadex for NMB reversal
313264|NCT01213264|O1|Outcome|Spontaneous Reversal|Participants whose reversal from NMB was spontaneous (no reversal agent used)
313265|NCT01213264|E3|Reported Event|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
313266|NCT01213264|E2|Reported Event|Sugammadex|Participants administered sugammadex for NMB reversal
313267|NCT01213264|E1|Reported Event|Spontaneous Reversal|Participants whose reversal from NMB was spontaneous (no reversal agent used)
313268|NCT01213251|B4|Baseline|Total|Total of all reporting groups
313269|NCT01213251|B3|Baseline|Control|Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management.
313270|NCT01213251|B2|Baseline|Dual Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
313271|NCT01213251|B1|Baseline|Single Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
313272|NCT01213251|P3|Participant Flow|Control|Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management.
313273|NCT01213251|P2|Participant Flow|Dual Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
313274|NCT01213251|P1|Participant Flow|Single Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
313275|NCT01213251|O1|Outcome|All Subjects|All subjects randomized in the study (either control, single pacing or dual pacing). For the patients randomized to single or dual site, only patients with successful implant are included.
313276|NCT01213251|O2|Outcome|Control|Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
313277|NCT01213251|O1|Outcome|Pooled Pacing|Subjects successfully implanted with a CRT-D device (either single or dual pacing).
313278|NCT01213251|O2|Outcome|Control|Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
313279|NCT01213251|O1|Outcome|Pooled Pacing|Subjects successfully implanted with a CRT-D device (either single or dual pacing).
313280|NCT01213251|O2|Outcome|Control|Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
313281|NCT01213251|O1|Outcome|Pooled Pacing|Subjects successfully implanted with a CRT-D device (either single or dual pacing).
313282|NCT01213251|O2|Outcome|Control|Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
313283|NCT01213251|O1|Outcome|Pooled Pacing|Subjects successfully implanted with a CRT-D device (either single or dual pacing).
313284|NCT01213251|O3|Outcome|Control|Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
313285|NCT01213251|O2|Outcome|Dual Site Pacing|Subjects randomized to the group that were successfully be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
313286|NCT01213251|O1|Outcome|Single Site Pacing|Subjects randomized to the group that were successfully implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
313287|NCT01213251|O2|Outcome|Dual Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
313288|NCT01213251|O1|Outcome|Single Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
313289|NCT01213251|O2|Outcome|Control|Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
314358|NCT01210079|B1|Baseline|Gabapentin|Gabapentin titrated to 2400 mg daily PO for 5 weeks
313292|NCT01213251|E2|Reported Event|Dual Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
313293|NCT01213251|E1|Reported Event|Single Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
313294|NCT01213199|B1|Baseline|Differin® 0.3% Gel|"Differin® 0.3% Gel Adapalene 0.3%~Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks."
313295|NCT01213199|P1|Participant Flow|Differin® 0.3% Gel|"Differin® 0.3% Gel Adapalene 0.3%~Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks."
313296|NCT01213199|O1|Outcome|Differin® 0.3% Gel|"Differin® 0.3% Gel Adapalene 0.3%~Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks."
313297|NCT01213199|E1|Reported Event|Differin® 0.3% Gel|"Differin® 0.3% Gel Adapalene 0.3%~Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks."
313298|NCT01213173|B3|Baseline|Total|Total of all reporting groups
313299|NCT01213173|B2|Baseline|Experimental|lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
313300|NCT01213173|B1|Baseline|Active Comparator|lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
313301|NCT01213173|P2|Participant Flow|Experimental|lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
313302|NCT01213173|P1|Participant Flow|Active Comparator|lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
313303|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
313304|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
313305|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
313306|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
313307|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
313308|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
313309|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
313310|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
313311|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
313312|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
313313|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
313314|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
313315|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
313316|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
313317|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
313318|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
313319|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
313320|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
313321|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
313322|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
313323|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
313324|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
313325|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
313326|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
313327|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
313328|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
313329|NCT01213173|E2|Reported Event|Experimental|lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
313330|NCT01213173|E1|Reported Event|Active Comparator|lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
313331|NCT01213043|B3|Baseline|Total|Total of all reporting groups
313332|NCT01213043|B2|Baseline|120 mg/kg - 60 mg/kg Prolastin-C Treatment Sequence|Weekly infusions of 120 mg/kg Prolastin-C for 8 weeks followed by a 2-week off-treatment washout period followed by weekly infusions of 60 mg/kg Prolastin-C for 8 weeks (total of 16 treatment weeks)
313333|NCT01213043|B1|Baseline|60 mg/kg - 120 mg/kg Prolastin-C Treatment Sequence|Weekly infusions of 60 mg/kg Prolastin-C for 8 weeks followed by a 2-week off-treatment washout period followed by weekly infusions of 120 mg/kg Prolastin-C for 8 weeks (total of 16 treatment weeks)
313334|NCT01213043|P2|Participant Flow|120 mg/kg - 60 mg/kg Prolastin-C Treatment Sequence|Weekly infusions of 120 mg/kg Prolastin-C for 8 weeks followed by a 2-week off-treatment washout period followed by weekly infusions of 60 mg/kg Prolastin-C for 8 weeks (total of 16 treatment weeks)
313335|NCT01213043|P1|Participant Flow|60 mg/kg - 120 mg/kg Prolastin-C Treatment Sequence|Weekly infusions of 60 mg/kg Prolastin-C for 8 weeks followed by a 2-week off-treatment washout period followed by weekly infusions of 120 mg/kg Prolastin-C for 8 weeks (total of 16 treatment weeks)
313336|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
313337|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
313338|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
313339|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
313340|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
313341|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
313342|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
313343|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
313344|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
313345|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
313346|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
313347|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
313348|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
313349|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
313350|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
313351|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
313352|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
313353|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
313354|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
313355|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
313356|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
313357|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
313358|NCT01213043|E2|Reported Event|120 mg/kg Prolastin-C|
313359|NCT01213043|E1|Reported Event|60 mg/kg Prolastin-C|
313360|NCT01212991|B3|Baseline|Total|Total of all reporting groups
314508|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
313361|NCT01212991|B2|Baseline|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
313362|NCT01212991|B1|Baseline|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
313363|NCT01212991|P2|Participant Flow|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
313364|NCT01212991|P1|Participant Flow|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
313365|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
313366|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
313367|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
313368|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
313369|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
313370|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
313371|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
313372|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
313373|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
313374|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
313375|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
313376|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
313377|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
313378|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
313379|NCT01212991|E2|Reported Event|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
313380|NCT01212991|E1|Reported Event|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
313381|NCT01212874|B3|Baseline|Total|Total of all reporting groups
313382|NCT01212874|B2|Baseline|Esmolol|"esmolol infusion titrated to control hypertension from anesthesia induction to initiation of cardiopulmonary bypass~esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension."
313383|NCT01212874|B1|Baseline|Nitroglycerin|"nitroglycerin infusion titrated to control hypertension from anesthesia induction to initiation of cardiopulmonary bypass~nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery."
313384|NCT01212874|P2|Participant Flow|Nitroglycerin|nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
313385|NCT01212874|P1|Participant Flow|Esmolol|esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension.
313386|NCT01212874|O2|Outcome|Nitroglycerin|nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
313387|NCT01212874|O1|Outcome|Esmolol|esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension.
313388|NCT01212874|O2|Outcome|Nitroglycerin|nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
313389|NCT01212874|O1|Outcome|Esmolol|esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension.
313390|NCT01212874|E2|Reported Event|Nitroglycerin|nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
313391|NCT01212874|E1|Reported Event|Esmolol|esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension.
313392|NCT01212770|B4|Baseline|Total|Total of all reporting groups
313393|NCT01212770|B3|Baseline|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313394|NCT01212770|B2|Baseline|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313395|NCT01212770|B1|Baseline|Placebo|Participants initially randomized to receive placebo tablets twice daily.
313396|NCT01212770|P9|Participant Flow|Placebo/Apremilast 30 mg (Long-Term Safety Phase)|Participants initially randomized to placebo tablets BID during the 24-week placebo-controlled phase were re-randomized to apremilast 30 mg tablets twice daily at Week 16 or Week 24 and continued receiving apremilast 30 mg tablets twice daily in the active treatment / long-term safety phase.
313397|NCT01212770|P8|Participant Flow|Placebo/Apremilast 20 mg (Long-Term Safety Phase)|Participants initially randomized to placebo tablets twice daily during the 24-week placebo-controlled phase were re-randomized to 20 mg apremilast tablets twice daily at Week 16 or Week 24 and continued receiving apremilast 20 mg tablets twice daily in active treatment / long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose).
313398|NCT01212770|P7|Participant Flow|Placebo / Apremilast 30 mg XO|Participants initially randomized to placebo twice daily were re-randomized at Week 24 to 30 mg apremilast twice daily in the active treatment phase.
313399|NCT01212770|P6|Participant Flow|Placebo / Apremilast 30 mg EE|Participants initially randomized to placebo twice daily were re-randomized due to early escape (EE) at Week 16 began receiving 30 mg apremilast tablets twice daily in the active treatment phase.
313400|NCT01212770|P5|Participant Flow|Placebo / Apremilast 20 mg XO|Participants initially randomized to receive placebo twice daily were re-randomized at Week 24 (XO) to 20 mg apremilast tablets twice daily in the active treatment phase.
313401|NCT01212770|P4|Participant Flow|Placebo / Apremilast 20 mg EE|Participants initially randomized to placebo twice daily were re-randomized due to early escape (EE) at Week 16 and began to receive 20 mg apremilast twice a day in the active treatment phase.
313402|NCT01212770|P3|Participant Flow|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily during the 24-week placebo-controlled phase continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313403|NCT01212770|P2|Participant Flow|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo-controlled phase continued receiving 20 mg apremilast tablets twice daily in the active treatment / long-term safety phase (LTSP).
313404|NCT01212770|P1|Participant Flow|Placebo|Participants initially randomized to receive placebo tablets twice daily (BID) in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313405|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants who received apremilast 30 mg twice daily regardless of when the apremilast-exposure started (at Week 0, 16, or 24).
313406|NCT01212770|O2|Outcome|Apremilast 20/30 mg (Post-switch)|Participants who switched from apremilast 20 mg BID to apremilast 30 mg BID. Only the TEAEs that occurred during APR 30 mg BID treatment were included.
313407|NCT01212770|O1|Outcome|Apremilast 20 mg (Pre-switch)|Participants who received apremilast 20 mg twice daily regardless of when the apremilast exposure started (at Week 0, 16, or 24). Only the TEAEs that occurred during apremilast 20 mg BID were counted.
313408|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants who received 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase.
313409|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants who received 20 mg apremilast tablets twice daily in the 24-week placebo-controlled phase.
313410|NCT01212770|O1|Outcome|Placebo|Participants received placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were rerandomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313411|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313412|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313413|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
313414|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
313415|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313416|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313417|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
313418|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
313419|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313420|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313421|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
313422|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
313423|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313424|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313425|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
313426|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
313427|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313428|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313429|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
313430|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
313431|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313432|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313433|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
313434|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
313435|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313436|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313437|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
313438|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
313439|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313440|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313441|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
313442|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
313443|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313444|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313445|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
313446|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
313447|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313448|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313449|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
313450|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
313451|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313452|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313453|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
313454|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
313455|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313456|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313457|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
313458|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
313459|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313460|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313461|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
313462|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
313463|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313464|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313465|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
313466|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
313467|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313468|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313469|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
313470|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
313471|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313472|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313473|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
313474|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
313475|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313476|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313477|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
313478|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
313479|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313480|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313525|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313481|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
313482|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
313483|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313484|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313485|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
313486|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313487|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313488|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
313489|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313490|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313491|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
313492|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313493|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313494|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
313495|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313496|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313497|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
313498|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313499|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313500|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
313501|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313502|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313503|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
313504|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313505|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313506|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
313507|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313508|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313509|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
313510|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313511|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313512|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
313513|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313514|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313515|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
313516|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313517|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313518|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
313519|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313520|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313521|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
313522|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313523|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313524|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
313526|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313527|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
313528|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313529|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313530|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
313531|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313532|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313533|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
313534|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313535|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313536|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
313537|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313538|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313539|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
313540|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313541|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313542|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
313543|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313544|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313545|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
313546|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313547|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313548|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
313549|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313550|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313551|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
313552|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313553|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313554|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
313555|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313556|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313557|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
313558|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313559|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313560|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
313561|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313562|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313563|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
313564|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313565|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313566|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
313567|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313568|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313569|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
313570|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313571|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313572|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
313573|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313574|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313575|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
313576|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313577|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313578|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
313579|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313580|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313581|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
313582|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313583|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313584|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
313585|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313586|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313587|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
313588|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
313589|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
313590|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
313591|NCT01212770|E6|Reported Event|APR Exposure Period Up to 5 Years: Apremilast 30 mg|Participants who received apremilast 30 mg twice daily throughout the study regardless of when the apremilast-exposure started (at Week 0, 16, or 24).
313592|NCT01212770|E5|Reported Event|APR Exposure Period Up to 5 Years: Apremilast 20mg/30 mg|Participants who switched from apremilast 20 mg twice daily to apremilast 30 mg BID. Only the TEAEs that occurred during apremilast 30 mg twice daily treatment were included.
313593|NCT01212770|E4|Reported Event|APR Exposure Period Up to 5 Years: Apremilast 20 mg|Participants who received apremilast 20 mg twice daily regardless of when the apremilast exposure started (at Week 0, 16 or 24). Only TEAEs that occurred during apremilast 20 mg BID treatment (before the switch to 30 mg apremilast) were included.
313594|NCT01212770|E3|Reported Event|Weeks 0-24: Apremilast 30 mg (Placebo- Controlled Phase)|Participants received 30 mg apremilast tablets PO twice daily during the 24-week placebo-controlled phase.
313595|NCT01212770|E2|Reported Event|Weeks 0-24: Apremilast 20 mg (Placebo- Controlled Phase)|Participants received 20 mg apremilast tablets PO twice daily during the 24-week placebo-controlled phase.
313596|NCT01212770|E1|Reported Event|Weeks 0-24: Placebo (Placebo-Controlled Phase)|Participants received placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for participants who escaped early, and through Week 24 for all other participants.
313597|NCT01212757|B4|Baseline|Total|Total of all reporting groups
313598|NCT01212757|B3|Baseline|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313599|NCT01212757|B2|Baseline|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313600|NCT01212757|B1|Baseline|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313601|NCT01212757|P9|Participant Flow|Placebo/Apremilast 30 mg (Long-Term Safety Phase)|Participants initially randomized to placebo tablets twice daily during the placebo controlled phase were re-randomized to apremilast 30 mg tablets twice daily at Week 16 or Week 24 and continued receiving apremilast 30 mg twice daily in the active treatment / long-term safety phase.
313602|NCT01212757|P8|Participant Flow|Placebo/Apremilast 20 mg (Long-Term Safety Phase)|Participants initially randomized to placebo tablets twice daily during the placebo controlled phase were re-randomized to 20 mg apremilast twice daily at Week 16 or Week 24 and continued receiving apremilast 20 mg twice daily in the active treatment / long-term safety phase. (After 30 mg apremilast twice daily was identified as the optimal dose, all participants receiving 20 mg apremilast twice daily were switched to the 30 mg apremilast twice daily dose).
313603|NCT01212757|P7|Participant Flow|Placebo / Apremilast 30 mg XO|Participants initially randomized to placebo twice daily in the 24-week placebo-controlled phase were re-randomized at Week 24 to 30 mg apremilast tablets twice daily in the active treatment phase.
313604|NCT01212757|P6|Participant Flow|Placebo / Apremilast 30 mg EE|Participants initially randomized to placebo twice daily in the 24-week placebo controlled phase were re-randomized due to early escape (EE) at Week 16 to 30 mg apremilast tablets twice daily in the active-treatment phase.
314509|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
313605|NCT01212757|P5|Participant Flow|Placebo / Apremilast 20 mg XO|Participants initially randomized to receive placebo twice daily in the 24-week placebo-controlled phase were re-randomized at Week 24 (XO) to 20 mg apremilast tablets twice daily in the active treatment phase.
313606|NCT01212757|P4|Participant Flow|Placebo / Apremilast 20 mg EE|Participants initially randomized to placebo twice daily in the 24-week placebo-controlled phase were re-randomized due to early escape (EE) at Week 16 and began receiving 20 mg apremilast tablets twice a day in the active treatment phase.
313607|NCT01212757|P3|Participant Flow|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313608|NCT01212757|P2|Participant Flow|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313609|NCT01212757|P1|Participant Flow|Placebo|Participants initially randomized to placebo tablets twice daily (BID) in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313610|NCT01212757|O3|Outcome|Apremilast 30 mg BID|Participants who received apremilast 30 mg twice daily regardless of when the apremilast-exposure started (at Weeks 0, 16, or 24).
313611|NCT01212757|O2|Outcome|Apremilast 20 mg/30 mg (Post-switch)|Participants who switched from apremilast 20 mg BID to apremilast 30 mg BID. Only the TEAEs that occurred during APR 30 mg BID treatment were included.
313612|NCT01212757|O1|Outcome|Apremilast 20 mg (Pre-switch)|Participants who received apremilast 20 mg BID regardless of when the apremilast exposure started (at week 0, 16 and 24). Only the TEAEs that occurred during apremilast 20 mg BID treatment (before the switch to 30 mg apremilast) were included.
313613|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313614|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313615|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313616|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313617|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313618|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 30 mg apremilast tablets twice daily and continued receiving apremilast 30 mg in the active treatment/long-term phase.
313619|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 20 mg apremilast tablets twice daily and continued receiving apremilast 20 mg in the active treatment/long-term phase.
313620|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313621|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313622|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 30 mg apremilast tablets twice daily and continued receiving apremilast 30 mg in the active treatment/long-term phase.
313623|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 20 mg apremilast tablets twice daily and continued receiving apremilast 20 mg in the active treatment/long-term phase.
313624|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313625|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313626|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 30 mg apremilast tablets twice daily and continued receiving apremilast 30 mg in the active treatment/long-term phase.
313627|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 20 mg apremilast tablets twice daily and continued receiving apremilast 20 mg in the active treatment/long-term phase.
313628|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313629|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313630|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 30 mg apremilast tablets twice daily and continued receiving apremilast 30 mg in the active treatment/long-term phase.
313631|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 20 mg apremilast tablets twice daily and continued receiving apremilast 20 mg in the active treatment/long-term phase.
313632|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313633|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313634|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 30 mg apremilast tablets twice daily and continued receiving apremilast 30 mg in the active treatment/long-term phase.
313635|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 20 mg apremilast tablets twice daily and continued receiving apremilast 20 mg in the active treatment/long-term phase.
313636|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313637|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313638|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 30 mg apremilast tablets twice daily and continued receiving apremilast 30 mg in the active treatment/long-term phase.
313639|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 20 mg apremilast tablets twice daily and continued receiving apremilast 20 mg in the active treatment/long-term phase.
313640|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313641|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313642|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 30 mg apremilast tablets twice daily and continued receiving apremilast 30 mg in the active treatment/long-term phase.
313643|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 20 mg apremilast tablets twice daily and continued receiving apremilast 20 mg in the active treatment/long-term phase.
313644|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313645|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313646|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 30 mg apremilast tablets twice daily and continued receiving apremilast 30 mg in the active treatment/long-term phase.
313647|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 20 mg apremilast tablets twice daily and continued receiving apremilast 20 mg in the active treatment/long-term phase.
313648|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313649|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313650|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 30 mg apremilast tablets twice daily and continued receiving apremilast 30 mg in the active treatment/long-term phase.
313651|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 20 mg apremilast tablets twice daily and continued receiving apremilast 20 mg in the active treatment/long-term phase.
313652|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313653|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313654|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 30 mg apremilast tablets twice daily and continued receiving apremilast 30 mg in the active treatment/long-term phase.
313655|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 20 mg apremilast tablets twice daily and continued receiving apremilast 20 mg in the active treatment/long-term phase.
313656|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313657|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313658|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 30 mg apremilast tablets twice daily and continued receiving apremilast 30 mg in the active treatment/long-term phase.
313659|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 20 mg apremilast tablets twice daily and continued receiving apremilast 20 mg in the active treatment/long-term phase.
313660|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313661|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313662|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 30 mg apremilast tablets twice daily and continued receiving apremilast 30 mg in the active treatment/long-term phase.
313663|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 20 mg apremilast tablets twice daily and continued receiving apremilast 20 mg in the active treatment/long-term phase.
313664|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313665|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313666|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 30 mg apremilast tablets twice daily and continued receiving apremilast 30 mg in the active treatment/long-term phase.
313667|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 20 mg apremilast tablets twice daily and continued receiving apremilast 20 mg in the active treatment/long-term phase.
313668|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313669|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313670|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 30 mg apremilast tablets twice daily and continued receiving apremilast 30 mg in the active treatment/long-term phase.
313671|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 20 mg apremilast tablets twice daily and continued receiving apremilast 20 mg in the active treatment/long-term phase.
313672|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313673|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313674|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 30 mg apremilast tablets twice daily and continued receiving apremilast 30 mg in the active treatment/long-term phase.
313675|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 20 mg apremilast tablets twice daily and continued receiving apremilast 20 mg in the active treatment/long-term phase.
313676|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313677|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313678|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 30 mg apremilast tablets twice daily and continued receiving apremilast 30 mg in the active treatment/long-term phase.
313679|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 20 mg apremilast tablets twice daily and continued receiving apremilast 20 mg in the active treatment/long-term phase.
313680|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313681|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313682|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 30 mg apremilast tablets twice daily and continued receiving apremilast 30 mg in the active treatment/long-term phase.
313683|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 were re-randomized to 20 mg apremilast tablets twice daily and continued receiving apremilast 20 mg in the active treatment/long-term phase.
313684|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313685|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313686|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313687|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313688|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313689|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313690|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313691|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313692|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313693|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313694|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313695|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313696|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313697|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313698|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313846|NCT01212185|B2|Baseline|Intranasal Oxytocin Spray|"Twice daily intranasal oxytocin spray~intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days"
313699|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313700|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313701|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313702|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313703|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313704|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313705|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313706|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313707|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313708|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313709|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313710|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313711|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313712|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313713|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313714|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313715|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313716|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313717|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313718|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313719|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313720|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313721|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313722|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313723|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313724|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313725|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313726|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313727|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313728|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313729|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313730|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313731|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313732|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313733|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313734|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313735|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313736|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313737|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313738|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313739|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313740|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313741|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313816|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
313742|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313743|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313744|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313745|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313746|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313747|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313748|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313749|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313750|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313751|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313752|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313753|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313754|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313755|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313756|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313757|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313758|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313759|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313760|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313761|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313762|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313817|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313763|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313764|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313765|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313766|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313767|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313768|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313769|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313770|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313771|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313772|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313773|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313774|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313775|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313776|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313777|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313778|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313779|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313780|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313781|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313782|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313783|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase, continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.
313818|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313784|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued receiving 20 mg apremilast tablets twice daily in the active treatment/long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to 30 mg apremilast BID dose).
313785|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
313786|NCT01212757|E6|Reported Event|APR Exposure Period Up to 5 Years: APR 30 mg|Participants who received 30 mg apremilast twice daily regardless of when their apremilast-exposure started (at Weeks 0, 16, or 24).
313787|NCT01212757|E5|Reported Event|APR Exposure Period Up to 5 Years: APR 20mg/30 mg|Participants who switched from apremilast 20 mg BID to apremilast 30 mg BID. Only the TEAEs that occurred during APR 30 mg BID treatment were included.
313788|NCT01212757|E4|Reported Event|APR Exposure Period Up to 5 Years: APR 20 mg|Participants who received apremilast 20 mg tablets twice daily regardless of when the apremilast exposure started (at Week 0, 16 or 24). Only the TEAEs that occurred during apremilast 20 mg BID treatment (before the switch to 30 mg apremilast) were included.
313789|NCT01212757|E3|Reported Event|Weeks 0-24: Apremilast 30 mg (Placebo- Controlled Phase)|Participants received 30 mg apremilast tablets PO BID during the 24-week placebo-controlled phase.
313790|NCT01212757|E2|Reported Event|Weeks 0-24: Apremilast 20 mg (Placebo- Controlled Phase)|Participants received 20 mg apremilast tablets PO BID during the 24-week placebo-controlled phase.
313791|NCT01212757|E1|Reported Event|Weeks 0-24: Placebo (Placebo-Controlled Phase)|Participants received placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for participants who escaped early, and through Week 24 for all other participants.
313792|NCT01212627|B1|Baseline|Ridaforolimus,|"Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression~Ridaforolimus: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle~Ridaforolimus"
313793|NCT01212627|P1|Participant Flow|Ridaforolimus,|"Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression~Ridaforolimus: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle~Ridaforolimus"
313794|NCT01212627|O1|Outcome|Ridaforolimus,|"Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression~Ridaforolimus: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle~Ridaforolimus"
313795|NCT01212627|E1|Reported Event|Ridaforolimus,|"Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression~Ridaforolimus: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle~Ridaforolimus"
313796|NCT01212484|B1|Baseline|All Study Subjects|
313797|NCT01212484|P2|Participant Flow|Carbidopa (First), Placebo (Second)|Subjects will be given Carbidopa for a 4 week period followed by placebo for a 4 week period.
313798|NCT01212484|P1|Participant Flow|Placebo (First), Carbidopa (Second)|Subjects will be given placebo first (4 weeks), followed by carbidopa (4 weeks).
313799|NCT01212484|O2|Outcome|Placebo|
313800|NCT01212484|O1|Outcome|Carbidopa|
313801|NCT01212484|O2|Outcome|Placebo|
313802|NCT01212484|O1|Outcome|Carbidopa|
313803|NCT01212484|O2|Outcome|Placebo|
313804|NCT01212484|O1|Outcome|Carbidopa|
313805|NCT01212484|E2|Reported Event|Placebo|"Placebo~Placebo : The trial will be divided into two consecutive, but independent parts. Phase 1, will address the safety and tolerability of carbidopa in patients with FD using an open-label dose titration phase followed by 4-weeks of open-label treatment. Phase 2, will address the efficacy of carbidopa for the treatment of nausea in patients with FD using a randomized, placebo controlled, double blind, 4-week cross over design."
313806|NCT01212484|E1|Reported Event|Carbidopa|"carbidopa~Carbidopa : The trial will be divided into two consecutive, but independent parts. Phase 1, will address the safety and tolerability of carbidopa in patients with FD using an open-label dose titration phase followed by 4-weeks of open-label treatment. Phase 2, will address the efficacy of carbidopa for the treatment of nausea in patients with FD using a randomized, placebo controlled, double blind, 4-week cross over design."
313807|NCT01212445|B4|Baseline|Total|Total of all reporting groups
313808|NCT01212445|B3|Baseline|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313809|NCT01212445|B2|Baseline|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313810|NCT01212445|B1|Baseline|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
313811|NCT01212445|P3|Participant Flow|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313812|NCT01212445|P2|Participant Flow|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313813|NCT01212445|P1|Participant Flow|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313814|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313815|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313819|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
313820|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313821|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313822|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
313823|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313824|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313825|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313826|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313827|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313828|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313829|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313830|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313831|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
313832|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313833|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313834|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
313835|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313836|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313837|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313838|NCT01212445|E3|Reported Event|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313839|NCT01212445|E2|Reported Event|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313840|NCT01212445|E1|Reported Event|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
313841|NCT01212302|B1|Baseline|Aspirin, Clopidogrel|If the treatment with aspirin and/or clopidogrel is insufficient (platelet function testing) the dose was increased or the drug was changed (clopidogrel to ticlopidine or prasugrel)
313842|NCT01212302|P1|Participant Flow|Aspirin, Clopidogrel|If the treatment with aspirin and/or clopidogrel is insufficient (platelet function testing) the dose was increased or the drug was changed (clopidogrel to ticlopidine or prasugrel)
313843|NCT01212302|O1|Outcome|Clopidogrel Low Response|If the treatment with aspirin and/or clopidogrel is insufficient (platelet function testing) the dose was increased or the drug was changed (clopidogrel to ticlopidine or prasugrel)
313844|NCT01212302|E1|Reported Event|Aspirin, Clopidogrel|If the treatment with aspirin and/or clopidogrel is insufficient (platelet function testing) the dose was increased or the drug was changed (clopidogrel to ticlopidine or prasugrel)
313845|NCT01212185|B3|Baseline|Total|Total of all reporting groups
313847|NCT01212185|B1|Baseline|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin.~intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily"
313848|NCT01212185|P2|Participant Flow|Intranasal Oxytocin Spray|"Twice daily intranasal oxytocin spray~intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days"
313849|NCT01212185|P1|Participant Flow|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin.~intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily for 3 days"
313850|NCT01212185|O2|Outcome|Intranasal Oxytocin Spray|"Twice daily intranasal oxytocin spray~intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days"
313851|NCT01212185|O1|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin.~intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily"
313852|NCT01212185|O2|Outcome|Intranasal Oxytocin Spray|"Twice daily intranasal oxytocin spray~intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days"
313853|NCT01212185|O1|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin.~intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily"
313854|NCT01212185|E2|Reported Event|Intranasal Oxytocin Spray|"Twice daily intranasal oxytocin spray~intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days"
313855|NCT01212185|E1|Reported Event|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin.~intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily"
313856|NCT01212172|B1|Baseline|Side-by Side Comparsion of Soprano/SHR to Light Sheer|"Alma Soprano/SHR 810 nm Diode Laser~Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time.~LightSheer Duet 810 nm diode laser~LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings."
313857|NCT01212172|P2|Participant Flow|LightSheer Duet 810 nm Diode Laser|"Soprano and LightSheer Duet 810 nm diode laser~LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings."
313858|NCT01212172|P1|Participant Flow|Soprano Duet 810 nm Diode Laser|"Soprano Duet 810 nm diode laser~Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time."
313859|NCT01212172|O2|Outcome|Soprano/SHR|"Alma Soprano/SHR 810 nm Diode Laser~Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time."
313860|NCT01212172|O1|Outcome|LightSheer|"LightSheer Duet 810 nm diode laser~LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings."
313861|NCT01212172|O2|Outcome|LightSheer|"LightSheer Duet 810 nm diode laser~LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings."
313862|NCT01212172|O1|Outcome|Soprano/SHR|"Alma Soprano/SHR 810 nm Diode Laser~Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time."
313863|NCT01212172|E2|Reported Event|Light Sheer 810 nm Diode Laser|"Light Sheer 810 nm Diode Laser~Left Axilla or Lower Leg~LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings."
313864|NCT01212172|E1|Reported Event|Soprano/SHR 810 nm Diode Laser|"Alma Soprano/SHR VS Light Sheer Duet 810 nm Diode Lasers~Right Axilla or Lower Leg~Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time."
313865|NCT01212159|B3|Baseline|Total|Total of all reporting groups
313866|NCT01212159|B2|Baseline|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.~Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
313867|NCT01212159|B1|Baseline|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
313868|NCT01212159|P2|Participant Flow|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.~Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
313869|NCT01212159|P1|Participant Flow|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
313927|NCT01211769|B4|Baseline|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone chlorhydrate 50 mg"
313870|NCT01212159|O2|Outcome|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.~Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
313871|NCT01212159|O1|Outcome|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
313872|NCT01212159|O2|Outcome|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.~Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
313873|NCT01212159|O1|Outcome|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
313874|NCT01212159|O2|Outcome|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.~Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
313875|NCT01212159|O1|Outcome|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
313876|NCT01212159|E2|Reported Event|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.~Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
313877|NCT01212159|E1|Reported Event|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
313878|NCT01212094|B4|Baseline|Total|Total of all reporting groups
313879|NCT01212094|B3|Baseline|Baseline|Patients in their first year baseline prior to treatment phase
313880|NCT01212094|B2|Baseline|Rituximab|Group administered active drug
313881|NCT01212094|B1|Baseline|Placebo|Group administered placebo
313882|NCT01212094|P3|Participant Flow|Rituximab|Group administered active drug
313883|NCT01212094|P2|Participant Flow|Placebo|Group administered placebo
313884|NCT01212094|P1|Participant Flow|Baseline|Patients in their first year baseline prior to study drug phase
313885|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
313886|NCT01212094|O1|Outcome|Placebo|Group administered placebo
313887|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
313888|NCT01212094|O1|Outcome|Placebo|Group administered placebo
313889|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
313890|NCT01212094|O1|Outcome|Placebo|Group administered placebo
313891|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
313892|NCT01212094|O1|Outcome|Placebo|Group administered placebo
313893|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
313894|NCT01212094|O1|Outcome|Placebo|Group administered placebo
313895|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
313896|NCT01212094|O1|Outcome|Placebo|Group administered placebo
313897|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
313898|NCT01212094|O1|Outcome|Placebo|Group administered placebo
313899|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
313900|NCT01212094|O1|Outcome|Placebo|Group administered placebo
313901|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
313902|NCT01212094|O1|Outcome|Placebo|Group administered placebo
313903|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
313904|NCT01212094|O1|Outcome|Placebo|Group administered placebo
313905|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
313906|NCT01212094|O1|Outcome|Placebo|Group administered placebo
313907|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
313908|NCT01212094|O1|Outcome|Placebo|Group administered placebo
313909|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
313910|NCT01212094|O1|Outcome|Placebo|Group administered placebo
313911|NCT01212094|E3|Reported Event|Baseline|Patients in their first year baseline prior to study drug phase
313912|NCT01212094|E2|Reported Event|Rituximab|Group who got active drug
313913|NCT01212094|E1|Reported Event|Placebo|Placebo group
313914|NCT01211873|B4|Baseline|Total|Total of all reporting groups
313915|NCT01211873|B3|Baseline|Dotarem 2 (Gadoterate Meglumine )|All children were assigned to Dotarem
313916|NCT01211873|B2|Baseline|Dotarem (Gadoterate Meglumine )|adults received Dotarem as 2:1 ratio compared to Magnevist.
313917|NCT01211873|B1|Baseline|Magnevist (Gadopentetate Dimeglumine)|adults received Magnevist as 1:2 ratio compared to Dotarem
313918|NCT01211873|P3|Participant Flow|Dotarem 2 (Gadoterate Meglumine )|Pediatric patients were assigned to Dotarem group only
313919|NCT01211873|P2|Participant Flow|Magnevist (Gadopentetate Dimeglumine)|Dotarem and Magnevist were randomised as 2:1 ratio
313920|NCT01211873|P1|Participant Flow|Dotarem (Gadoterate Meglumine )|Dotarem and Magnevist were randomised as 2:1 ratio for adult patients.
313921|NCT01211873|O2|Outcome|Dotarem (Gadoterate Meglumine ) PAIRED|all sequences pre and post injection wil be pooled as PAIRED
313922|NCT01211873|O1|Outcome|Dotarem (Gadoterate Meglumine ) PRE|any sequence acquired prior to injection will be pooled as PRE
313923|NCT01211873|E3|Reported Event|Dotarem 2 (Gadoterate Meglumine )|children were only assigned to Dotarem
313924|NCT01211873|E2|Reported Event|Magnevist (Gadopentetate Dimeglumine)|Dotarem and Magnevist were randomised as 2:1 ratio
313925|NCT01211873|E1|Reported Event|Dotarem (Gadoterate Meglumine )|Dotarem and Magnevist were randomised as 2:1 ratio for adults
313926|NCT01211769|B5|Baseline|Total|Total of all reporting groups
313928|NCT01211769|B3|Baseline|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
313929|NCT01211769|B2|Baseline|Naltrexone|"Naltrexone chlorhydrate 50 mg~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
313930|NCT01211769|B1|Baseline|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
313931|NCT01211769|P4|Participant Flow|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone chlorhydrate 50 mg"
313932|NCT01211769|P3|Participant Flow|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
313933|NCT01211769|P2|Participant Flow|Naltrexone|"Naltrexone chlorhydrate 50 mg~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
313934|NCT01211769|P1|Participant Flow|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
313935|NCT01211769|O4|Outcome|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone chlorhydrate 50 mg"
313936|NCT01211769|O3|Outcome|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
313937|NCT01211769|O2|Outcome|Naltrexone|"Naltrexone chlorhydrate 50 mg~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
313938|NCT01211769|O1|Outcome|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
313939|NCT01211769|O4|Outcome|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone chlorhydrate 50 mg"
313940|NCT01211769|O3|Outcome|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
313941|NCT01211769|O2|Outcome|Naltrexone|"Naltrexone chlorhydrate 50 mg~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
313942|NCT01211769|O1|Outcome|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
313943|NCT01211769|O4|Outcome|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone chlorhydrate 50 mg"
313944|NCT01211769|O3|Outcome|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
313945|NCT01211769|O2|Outcome|Naltrexone|"Naltrexone chlorhydrate 50 mg~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
313946|NCT01211769|O1|Outcome|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
313947|NCT01211769|E4|Reported Event|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone chlorhydrate 50 mg"
313948|NCT01211769|E3|Reported Event|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
313949|NCT01211769|E2|Reported Event|Naltrexone|"Naltrexone chlorhydrate 50 mg~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
313950|NCT01211769|E1|Reported Event|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
313951|NCT01211730|B3|Baseline|Total|Total of all reporting groups
313952|NCT01211730|B2|Baseline|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
313953|NCT01211730|B1|Baseline|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
313954|NCT01211730|P2|Participant Flow|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
313955|NCT01211730|P1|Participant Flow|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
314510|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
313956|NCT01211730|O2|Outcome|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
313957|NCT01211730|O1|Outcome|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
313958|NCT01211730|O2|Outcome|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
313959|NCT01211730|O1|Outcome|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
313960|NCT01211730|O2|Outcome|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
313961|NCT01211730|O1|Outcome|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
313962|NCT01211730|O2|Outcome|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
313963|NCT01211730|O1|Outcome|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
313964|NCT01211730|O2|Outcome|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
313965|NCT01211730|O1|Outcome|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
313966|NCT01211730|O2|Outcome|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
313967|NCT01211730|O1|Outcome|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
313968|NCT01211730|E2|Reported Event|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
313969|NCT01211730|E1|Reported Event|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
313970|NCT01211665|B3|Baseline|Total|Total of all reporting groups
313971|NCT01211665|B2|Baseline|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
313972|NCT01211665|B1|Baseline|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
313973|NCT01211665|P2|Participant Flow|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
313974|NCT01211665|P1|Participant Flow|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
313975|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
313976|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
313977|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
313978|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
313979|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
313980|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
313981|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
313982|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
313983|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
313984|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
313985|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
313986|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
313987|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
313988|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
313989|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
313990|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
313991|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
313992|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
313993|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
313994|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
313995|NCT01211665|E2|Reported Event|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
313996|NCT01211665|E1|Reported Event|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
313997|NCT01211613|B4|Baseline|Total|Total of all reporting groups
313998|NCT01211613|B3|Baseline|Standard Medical Care|"Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.~Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated."
313999|NCT01211613|B2|Baseline|Mechanical Manipulation|"Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.~Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants."
314000|NCT01211613|B1|Baseline|Manual Manipulation|"Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.~Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants."
314001|NCT01211613|P3|Participant Flow|Standard Medical Care|"Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.~Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated."
314002|NCT01211613|P2|Participant Flow|Mechanical Manipulation|"Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.~Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants."
314003|NCT01211613|P1|Participant Flow|Manual Manipulation|"Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.~Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants."
314029|NCT01211340|O2|Outcome|Intervention Arm|"These caregivers will receive usual care plus the technology which allows them to participate in their plan of care meeting~ACTIVE: Assessing Caregivers for Team Intervention via Video Encounters: this intervention uses video technology to bridge geographic distance to empower hospice caregivers to participate in plan of care meetings for their patient"
314004|NCT01211613|O3|Outcome|Standard Medical Care|"Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.~Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated."
314005|NCT01211613|O2|Outcome|Mechanical Manipulation|"Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.~Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants."
314006|NCT01211613|O1|Outcome|Manual Manipulation|"Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.~Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants."
314007|NCT01211613|O3|Outcome|Standard Medical Care|"Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.~Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated."
314008|NCT01211613|O2|Outcome|Mechanical Manipulation|"Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.~Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants."
314009|NCT01211613|O1|Outcome|Manual Manipulation|"Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.~Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants."
314010|NCT01211613|E3|Reported Event|Standard Medical Care|"Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.~Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated."
314011|NCT01211613|E2|Reported Event|Mechanical Manipulation|"Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.~Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants."
314012|NCT01211613|E1|Reported Event|Manual Manipulation|"Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.~Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants."
314013|NCT01211535|B3|Baseline|Total|Total of all reporting groups
314014|NCT01211535|B2|Baseline|ReNu Biotrue|ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
314015|NCT01211535|B1|Baseline|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
314016|NCT01211535|P2|Participant Flow|ReNu Biotrue|ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
314017|NCT01211535|P1|Participant Flow|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
314018|NCT01211535|O2|Outcome|ReNu Biotrue|ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
314019|NCT01211535|O1|Outcome|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
314020|NCT01211535|E2|Reported Event|ReNu Biotrue|ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
314021|NCT01211535|E1|Reported Event|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
314022|NCT01211340|B3|Baseline|Total|Total of all reporting groups
314023|NCT01211340|B2|Baseline|Intervention Arm|"These caregivers will receive usual care plus the technology which allows them to participate in their plan of care meeting~ACTIVE: Assessing Caregivers for Team Intervention via Video Encounters: this intervention uses video technology to bridge geographic distance to empower hospice caregivers to participate in plan of care meetings for their patient"
314024|NCT01211340|B1|Baseline|Usual Care|This arm serves as the control, individuals will not receive the intervention but will receive all measures
314025|NCT01211340|P2|Participant Flow|Intervention Arm|"These caregivers will receive usual care plus the technology which allows them to participate in their plan of care meeting~ACTIVE: Assessing Caregivers for Team Intervention via Video Encounters: this intervention uses video technology to bridge geographic distance to empower hospice caregivers to participate in plan of care meetings for their patient"
314026|NCT01211340|P1|Participant Flow|Usual Care|This arm serves as the control, individuals will not receive the intervention but will receive all measures
314027|NCT01211340|O2|Outcome|Intervention Arm|"These caregivers will receive usual care plus the technology which allows them to participate in their plan of care meeting~ACTIVE: Assessing Caregivers for Team Intervention via Video Encounters: this intervention uses video technology to bridge geographic distance to empower hospice caregivers to participate in plan of care meetings for their patient"
314028|NCT01211340|O1|Outcome|Usual Care|This arm serves as the control, individuals will not receive the intervention but will receive all measures
314114|NCT01211145|O3|Outcome|ZOMIG 2.5 mg|ZOMIG nasal spray
314030|NCT01211340|O1|Outcome|Usual Care|This arm serves as the control, individuals will not receive the intervention but will receive all measures
314031|NCT01211340|O2|Outcome|Intervention Arm|"These caregivers will receive usual care plus the technology which allows them to participate in their plan of care meeting~ACTIVE: Assessing Caregivers for Team Intervention via Video Encounters: this intervention uses video technology to bridge geographic distance to empower hospice caregivers to participate in plan of care meetings for their patient"
314032|NCT01211340|O1|Outcome|Usual Care|This arm serves as the control, individuals will not receive the intervention but will receive all measures
314033|NCT01211340|E2|Reported Event|Intervention Arm|"These caregivers will receive usual care plus the technology which allows them to participate in their plan of care meeting~ACTIVE: Assessing Caregivers for Team Intervention via Video Encounters: this intervention uses video technology to bridge geographic distance to empower hospice caregivers to participate in plan of care meetings for their patient"
314034|NCT01211340|E1|Reported Event|Usual Care|This arm serves as the control, individuals will not receive the intervention but will receive all measures
314035|NCT01211197|B1|Baseline|Study Overall|"An open label, randomised, three-way crossover study. The three treatments administered were~Fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions~Fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions~A washout period of at least 7 days was respected between drug administrations."
314036|NCT01211197|P6|Participant Flow|FDC Fed / Individual Tablets Fasted / FDC Fasted|"Patients received the three treatments in the following order:~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions"
314037|NCT01211197|P5|Participant Flow|FDC Fed / FDC Fasted / Individual Tablets Fasted|"Patients received the three treatments in the following order:~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions"
314038|NCT01211197|P4|Participant Flow|Individual Tablets Fasted / FDC Fed / FDC Fasted|"Patients received the three treatments in the following order:~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions"
314039|NCT01211197|P3|Participant Flow|Individual Tablets Fasted / FDC Fasted / FDC Fed|"Patients received the three treatments in the following order:~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions"
314040|NCT01211197|P2|Participant Flow|FDC Fasted / FDC Fed / Individual Tablets Fasted|"Patients received the three treatments in the following order:~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions"
314041|NCT01211197|P1|Participant Flow|FDC Fasted / Individual Tablets Fasted / FDC Fed|"Patients received the three treatments in the following order:~FDC tablet, containing 12.5mg empagliflozin (BI 10773) and 1000mg metformin, under fasted conditions~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions"
314042|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
314043|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
314044|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
314045|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
314046|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
314047|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
314048|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
314049|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
314050|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
314051|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
314052|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
314053|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
314054|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
314055|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
314056|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
314057|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
314058|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
314059|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
314115|NCT01211145|O2|Outcome|ZOMIG 0.5 mg|ZOMIG nasal spray
314060|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
314061|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
314062|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
314063|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
314064|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
314065|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
314066|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
314067|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
314068|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
314069|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
314070|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
314071|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
314072|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
314073|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
314074|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
314075|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
314076|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
314077|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
314078|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
314079|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
314080|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
314081|NCT01211197|E3|Reported Event|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
314082|NCT01211197|E2|Reported Event|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
314083|NCT01211197|E1|Reported Event|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
314084|NCT01211184|B4|Baseline|Total|Total of all reporting groups
314085|NCT01211184|B3|Baseline|Carbohydrate Drink|Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth
314086|NCT01211184|B2|Baseline|Water|Patients undergo hip surgery after receiving 800 ml water by mouth the evening before surgery
314087|NCT01211184|B1|Baseline|Fasting|patients undergo surgery in the fasting state
314088|NCT01211184|P3|Participant Flow|Carbohydrate Drink|Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth
314089|NCT01211184|P2|Participant Flow|Water|Patients undergo hip surgery after receiving 800 ml water by mouth the evening before surgery
314090|NCT01211184|P1|Participant Flow|Fasting|patients undergo surgery in the fasting state
314091|NCT01211184|O3|Outcome|Nutrition Group|Drank a carbohydrate drink 800 ml in the evening before surgery and 400 ml 2 hrs before surgery
314092|NCT01211184|O2|Outcome|Water Group|Patients drank 800 ml of water 2 hrs before surgery
314093|NCT01211184|O1|Outcome|Fasting|Fasting before surgery
314094|NCT01211184|O3|Outcome|Nutrition Group|Patients drank 800 ml in the evening before surgery and 400 ml 2 hours before surgery of a commercially available carbohydrate drink (PreOp)
314095|NCT01211184|O2|Outcome|Water Group|Patients drank 800 ml of tap water 2 hrs before entering the operating room
314096|NCT01211184|O1|Outcome|Fasting Group|Patients did not ingest any drink or food from midnight before the surgery.
314097|NCT01211184|E3|Reported Event|Carbohydrate Drink|Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth
314098|NCT01211184|E2|Reported Event|Water|Patients undergo hip surgery after receiving 800 ml water by mouth the evening before surgery
314099|NCT01211184|E1|Reported Event|Fasting|patients undergo surgery in the fasting state
314100|NCT01211145|B5|Baseline|Total|Total of all reporting groups
314101|NCT01211145|B4|Baseline|ZOMIG 5 mg|ZOMIG nasal spray
314102|NCT01211145|B3|Baseline|ZOMIG 2.5 mg|ZOMIG nasal spray
314103|NCT01211145|B2|Baseline|ZOMIG 0.5 mg|ZOMIG nasal spray
314104|NCT01211145|B1|Baseline|Placebo|Placebo to ZOMIG nasal spray
314105|NCT01211145|P4|Participant Flow|ZOMIG 5 mg|ZOMIG nasal spray
314106|NCT01211145|P3|Participant Flow|ZOMIG 2.5 mg|ZOMIG nasal spray
314107|NCT01211145|P2|Participant Flow|ZOMIG 0.5 mg|ZOMIG nasal spray
314108|NCT01211145|P1|Participant Flow|Placebo|Placebo to ZOMIG nasal spray
314109|NCT01211145|O4|Outcome|ZOMIG 5 mg|ZOMIG nasal spray
314110|NCT01211145|O3|Outcome|ZOMIG 2.5 mg|ZOMIG nasal spray
314111|NCT01211145|O2|Outcome|ZOMIG 0.5 mg|ZOMIG nasal spray
314112|NCT01211145|O1|Outcome|Placebo|Placebo to ZOMIG nasal spray
314113|NCT01211145|O4|Outcome|ZOMIG 5 mg|ZOMIG nasal spray
314138|NCT01211106|B2|Baseline|Sequential Treatment|Motivational enhancement therapy is started for the first 4 weeks and only after addressing addiction is prolonged exposure therapy begun.
314139|NCT01211106|B1|Baseline|Integrated Care|Prolonged exposure treatment is combined with Motivational Enhancement therapy from the beginning of treatment.
314140|NCT01211106|P2|Participant Flow|Sequential Treatment|Motivational enhancement therapy is started for the first 4 weeks and only after addressing addiction is prolonged exposure therapy begun.
314141|NCT01211106|P1|Participant Flow|Integrated Care|Prolonged exposure treatment is combined with Motivational Enhancement therapy from the beginning of treatment.
314142|NCT01211106|O2|Outcome|Sequential Treatment|Motivational enhancement therapy is started for the first 4 weeks and only after addressing addiction is prolonged exposure therapy begun.
314143|NCT01211106|O1|Outcome|Integrated Care|Prolonged exposure treatment is combined with Motivational Enhancement therapy from the beginning of treatment.
314144|NCT01211106|O2|Outcome|Arm 2 Sequential Therapy|MET followed by Prolonged Exposure
314145|NCT01211106|O1|Outcome|Arm 1: Integrated Conditions|Motivational enhancement therapy combined with Prolonged Exposure therapy.
314146|NCT01211106|E2|Reported Event|Sequential Treatment|Motivational enhancement therapy is started for the first 4 weeks and only after addressing addiction is prolonged exposure therapy begun.
314147|NCT01211106|E1|Reported Event|Integrated Care|Prolonged exposure treatment is combined with Motivational Enhancement therapy from the beginning of treatment.
314148|NCT01210820|B3|Baseline|Total|Total of all reporting groups
314149|NCT01210820|B2|Baseline|Post Cataract With Residual Astigmatism|"Subjects who have had cataract removal surgery but have residual astigmatism.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
314150|NCT01210820|B1|Baseline|Natural Astigmatism|"Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
314151|NCT01210820|P2|Participant Flow|Post Cataract With Residual Astigmatism|"Subjects who have had cataract removal surgery but have residual astigmatism.~iFS™ Femtosecond Laser System : intrastromal arcuate cuts made with iFS™ femtosecond laser"
314152|NCT01210820|P1|Participant Flow|Natural Astigmatism|"Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.~iFS™ Femtosecond Laser System : intrastromal arcuate cuts made with iFS™ femtosecond laser"
314153|NCT01210820|O2|Outcome|Post Cataract With Residual Astigmatism|"Subjects who have had cataract removal surgery but have residual astigmatism.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
314154|NCT01210820|O1|Outcome|Natural Astigmatism|"Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
314155|NCT01210820|O2|Outcome|Post Cataract With Residual Astigmatism|"Subjects who have had cataract removal surgery but have residual astigmatism.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
314156|NCT01210820|O1|Outcome|Natural Astigmatism|"Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
314157|NCT01210820|E2|Reported Event|Post Cataract With Residual Astigmatism|"Subjects who have had cataract removal surgery but have residual astigmatism.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
314158|NCT01210820|E1|Reported Event|Natural Astigmatism|"Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
314159|NCT01210807|B3|Baseline|Total|Total of all reporting groups
314160|NCT01210807|B2|Baseline|ZCB00 Monofocal Intraocular Lens|Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
314161|NCT01210807|B1|Baseline|ZMB00 Multifocal Intraocular Lens|Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens
314162|NCT01210807|P2|Participant Flow|ZCB00 Monofocal Intraocular Lens|Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
314163|NCT01210807|P1|Participant Flow|ZMB00 Multifocal Intraocular Lens|Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens
314164|NCT01210807|O2|Outcome|ZCB00 Monofocal Intraocular Lens|Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
314165|NCT01210807|O1|Outcome|ZMB00 Multifocal Intraocular Lens|Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens
314166|NCT01210807|O2|Outcome|ZCB00 Monofocal Intraocular Lens|Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
314167|NCT01210807|O1|Outcome|ZMB00 Multifocal Intraocular Lens|Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens
314168|NCT01210807|E2|Reported Event|ZCB00 Monofocal Intraocular Lens|Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
314169|NCT01210807|E1|Reported Event|ZMB00 Multifocal Intraocular Lens|Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens
314170|NCT01210716|B1|Baseline|Overall Study Population|Includes groups randomized to receive Spectra first and AMICUS first.
314171|NCT01210716|P2|Participant Flow|AMICUS First, Then Spectra|Patients randomized to Test (AMICUS) procedure first. Second procedure performed was Control (Spectra).
314172|NCT01210716|P1|Participant Flow|Spectra First, Then AMICUS|Patients randomized to Control (Spectra) procedure first. Second procedure performed was Test (AMICUS).
314173|NCT01210716|O1|Outcome|Overall Study Population|Includes groups randomized to receive Spectra first and AMICUS first.
314174|NCT01210716|O2|Outcome|Spectra (Control)|Each evaluable patient underwent one complete TPE procedure on the COBE Spectra separator.
314175|NCT01210716|O1|Outcome|AMICUS (Test)|Each evaluable patient underwent one complete TPE procedure on the AMICUS separator.
314176|NCT01210716|E1|Reported Event|Overall Study Population|Includes groups randomized to receive Spectra first and AMICUS first.
314195|NCT01210651|O2|Outcome|Attention Control Group|Participants in this group met for 90-minute educational seminars on yoga history twice a week for a total of 8 weeks.
314177|NCT01210690|B1|Baseline|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
314178|NCT01210690|P1|Participant Flow|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
314179|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
314180|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and is not influenced by the study protocol.
314181|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
314182|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
314183|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
314184|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
314185|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
314186|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
314187|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
314188|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
314189|NCT01210690|E1|Reported Event|Patients, 1 - 11 Mths Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
314190|NCT01210651|B3|Baseline|Total|Total of all reporting groups
314191|NCT01210651|B2|Baseline|Attention Control Education Group|Participants in this group met for 90-minute education seminars on yoga history twice a week for a total of 8 weeks.
314192|NCT01210651|B1|Baseline|Hatha Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks.
314193|NCT01210651|P2|Participant Flow|Attention Control Education Group|Participants in this group met for 90-minute educational seminars on yoga history twice weekly for a total of 8 weeks.
314194|NCT01210651|P1|Participant Flow|Hatha Yoga Practice Group|Participants in this group met for 90-minute yoga practice sessions twice a weekly for a total of 8 weeks.
314196|NCT01210651|O1|Outcome|Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks.
314197|NCT01210651|O2|Outcome|Attention Control Education Group|Participants in this group met for 90-minute educational seminars on yoga history twice a week for a total of 8 weeks.
314198|NCT01210651|O1|Outcome|Hatha Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks.
314199|NCT01210651|O2|Outcome|Attention Control Education Group|Participants in this group met for 90-minute educational seminars on yoga history twice a week for a total of 8 weeks.
314200|NCT01210651|O1|Outcome|Hatha Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks.
314201|NCT01210651|O2|Outcome|Attention Control Education Group|Participants in this group attended 90-minute educational seminars on yoga history twice weekly for a total of 8 weeks.
314202|NCT01210651|O1|Outcome|Hatha Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks.
314203|NCT01210651|O2|Outcome|Attention Control Education Group|Participants in this group attended 90-minute educational seminars on yoga history twice weekly for a total of 8 weeks.
314204|NCT01210651|O1|Outcome|Hatha Yoga Practice Group|Participants in this group practiced 90-minute sessions of hatha yoga exercises twice weekly for a total of 8 weeks.
314205|NCT01210651|E2|Reported Event|Attention Control Group|Participants in this group met for 90-minute education seminars on yoga history and philosophy twice a week for a total of 8 weeks.
314206|NCT01210651|E1|Reported Event|Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks. week for a total of 8 weeks.
314207|NCT01210495|B5|Baseline|Total|Total of all reporting groups
314208|NCT01210495|B4|Baseline|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
314209|NCT01210495|B3|Baseline|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).
314210|NCT01210495|B2|Baseline|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
314211|NCT01210495|B1|Baseline|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
314212|NCT01210495|P4|Participant Flow|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
314213|NCT01210495|P3|Participant Flow|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).
314214|NCT01210495|P2|Participant Flow|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
314215|NCT01210495|P1|Participant Flow|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 milligrams (mg) twice daily (BID).
314216|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
314217|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).
314218|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
314219|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).
314220|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
314221|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
314222|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
314223|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
314224|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
314225|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
314226|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
314227|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).
314228|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
314229|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).
314230|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
314231|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).
314232|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
314233|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).
314234|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
314235|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).
314236|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
314237|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).
314238|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
314239|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).
314240|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
314241|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).
314242|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
314243|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).
314244|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
314245|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).
314246|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
314247|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).
314248|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
314249|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
314250|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
314251|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
314252|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
314253|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
314254|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
314255|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
314256|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
314257|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
314258|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
314259|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
314260|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
314261|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).
314262|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
314263|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).
314264|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
314265|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).
314266|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
314267|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).
314268|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
314269|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).
314270|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
314271|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).
314272|NCT01210495|E4|Reported Event|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
314273|NCT01210495|E3|Reported Event|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles).
314274|NCT01210495|E2|Reported Event|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non randomized portion of this study to determine the recommended starting dose of axitinib for this population.
314275|NCT01210495|E1|Reported Event|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
314276|NCT01210443|B1|Baseline|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
314277|NCT01210443|P1|Participant Flow|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
314278|NCT01210443|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
314279|NCT01210443|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
314280|NCT01210443|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
314281|NCT01210443|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
314282|NCT01210443|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
314283|NCT01210443|E1|Reported Event|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
314284|NCT01210222|B1|Baseline|Treatment (Trebananib)|"Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Trebananib: Given IV"
314285|NCT01210222|P1|Participant Flow|Treatment (Trebananib)|"Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Trebananib: Given IV"
314286|NCT01210222|O1|Outcome|Treatment (Trebananib)|"Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Trebananib: Given IV"
314287|NCT01210222|O1|Outcome|Treatment (Trebananib)|"Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Trebananib: Given IV"
314288|NCT01210222|O6|Outcome|Grade 5 (CTCAE v 4.0)|Number of patients who experienced a grade 5 event using common terminology criteria version 4.0
314289|NCT01210222|O5|Outcome|Grade 4 (CTCAE v 4.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
314290|NCT01210222|O4|Outcome|Grade 3 (CTCAE v 4.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
314291|NCT01210222|O3|Outcome|Grade 2 (CTCAE v 4.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
314292|NCT01210222|O2|Outcome|Grade 1 (CTCAE v 4.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
314293|NCT01210222|O1|Outcome|Grade 0|Number of patients who did not experience the specified AE.
314294|NCT01210222|O1|Outcome|Treatment (Trebananib)|"Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Trebananib: Given IV"
314295|NCT01210222|O1|Outcome|Treatment (Trebananib)|"Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Trebananib: Given IV"
314296|NCT01210222|E1|Reported Event|Treatment (Trebananib)|"Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Trebananib: Given IV"
314297|NCT01210170|B1|Baseline|All Study Participants|• participant with asthma were enrolled in the study
314298|NCT01210170|P1|Participant Flow|All Study Participants|"• Inhalation of 400 µg mometasone DPI 30 min before inhalation of 180 µg albuterol~Mometasone furoate: • Inhalation of 400 µg mometasone or placebo DPI 30 min before inhalation of 180 µg albuterol~• Inhalation of 400 µg mometasone or placebo DPI 60 min before inhalation of 180 µg albuterol"
314299|NCT01210170|O9|Outcome|200 mcg Mometasone 30 Minutes Before Albuterol|Inhalation of 200 µg mometasone 30 min before inhalation of 180 µg albuterol
314300|NCT01210170|O8|Outcome|200 mcg Mometasone 60 Minutes Before Albuterol|Inhalation of 200 µg mometasone 60 min before inhalation of 180 µg albuterol
314301|NCT01210170|O7|Outcome|200 mcg Mometasone and Albuterol Simultaneously|inhalation of 200 mcg mometasone immediately before inhalation of 180 mcg albuterol
314302|NCT01210170|O6|Outcome|Mometasone Placebo 60 Minutes Before Albuterol|Inhalation of mometasone placebo 60 min before inhalation of 180 µg albuterol
314303|NCT01210170|O5|Outcome|400 mcg Mometasone 60 Minutes Before Albuterol|Inhalation of 400 µg mometasone 60 min before inhalation of 180 µg albuterol
314304|NCT01210170|O4|Outcome|Mometasone Placebo and Albuterol Simultaneously|inhalation of mometasone placebo immediately before inhalation of 180 mcg albuterol.
314305|NCT01210170|O3|Outcome|400 mcg Mometasone and Albuterol Simultaneously|inhalation of 400 mcg mometasone immediately before inhalation of 180 mcg albuterol.
314306|NCT01210170|O2|Outcome|Mometasone Placebo 30 Minutes Before Albuterol|Inhalation of mometasone placebo 30 min before inhalation of 180 µg albuterol
314307|NCT01210170|O1|Outcome|400 mcg Mometasone 30 Minutes Before Albuterol|• Inhalation of 400 µg mometasone 30 min before inhalation of 180 µg albuterol
314308|NCT01210170|O9|Outcome|All Participants Received 200 mcg -60 Min|mometasone 200 mcg 60 minutes before inhalation of 180 mcg of albuterol
314309|NCT01210170|O8|Outcome|All Participants Received 200 mcg Mometasone Simultaneous|inhalation of mometasone placebo immediately before inhalation of 180 mcg albuterol
314310|NCT01210170|O7|Outcome|All Participants Received Placebo -60 Min|placebo 60 minutes before inhalation of 180 mcg of albuterol
314311|NCT01210170|O6|Outcome|All Participants Received 400 mcg -60 Min|mometasone 400 mcg 60 minutes before inhalation of 180 mcg of albuterol
314312|NCT01210170|O5|Outcome|All Participants Received 200 mcg Mometasone-30 Min|mometasone 200 mcg 30 minutes before inhalation of 180 mcg of albuterol
314313|NCT01210170|O4|Outcome|All Participants Received Placebo Simultaneously With Albutero|inhalation of mometasone placebo immediately before inhalation of 180 mcg albuterol.
314314|NCT01210170|O3|Outcome|All Participants Received 400 mcg Mometasone Simultaneous|inhalation of 400 mcg mometasone immediately before inhalation of 180 mcg albuterol
314315|NCT01210170|O2|Outcome|All Participants Received Placebo 30 Minutes Before Albuterol|mometasone placebo 30 minutes before albuterol 180 mcg inhalation
314316|NCT01210170|O1|Outcome|All Participants Received 400 mcg Mometasone-30 Min|mometasone 400 mcg 30 minutes before albuterol 180 mcg inhalation
314317|NCT01210170|E1|Reported Event|All Study Participants|Simultaneous inhalation of 400 µg mometasone DPI and 180 µg albuterol
314318|NCT01210144|B3|Baseline|Total|Total of all reporting groups
314319|NCT01210144|B2|Baseline|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
314353|NCT01210118|O1|Outcome|High Intensity Intervention|"Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the 5 Αs (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided."
314320|NCT01210144|B1|Baseline|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
314321|NCT01210144|P2|Participant Flow|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
314322|NCT01210144|P1|Participant Flow|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) gonadotropin-releasing hormone (GnRH) agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
314323|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
314324|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
314325|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
314326|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
314327|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
314328|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
314354|NCT01210118|E2|Reported Event|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
314329|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
314330|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
314331|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
314332|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
314333|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
314334|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
314335|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
314336|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
314337|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle®|Participants received 150 IU per day of r-hFSH (Gonal-F®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm [for both long agonist and multi-dose antagonist protocol], and with E2>1 mcg/L [for long agonist protocol]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation, either 0.1 mg GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) in long agonist protocol or 0.25 mg GnRH antagonist daily was started from Day 6 of GONAL-f® stimulation treatment in multi-dose antagonist protocol, as per SmPC.
314355|NCT01210118|E1|Reported Event|High Intensity Intervention|"Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the 5 Αs (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided."
314338|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle®|Participants received 150 IU per day of r-hFSH (Gonal-F®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm [for both long agonist and multi-dose antagonist protocol], and with E2>1 mcg/L [for long agonist protocol]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation, either 0.1 mg GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) in long agonist protocol or 0.25 mg GnRH antagonist daily was started from Day 6 of GONAL-f® stimulation treatment in multi-dose antagonist protocol, as per SmPC.
314339|NCT01210144|E2|Reported Event|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
314340|NCT01210144|E1|Reported Event|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
314341|NCT01210118|B3|Baseline|Total|Total of all reporting groups
314342|NCT01210118|B2|Baseline|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
314343|NCT01210118|B1|Baseline|High Intensity Intervention|"Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the 5 Αs (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided."
314344|NCT01210118|P2|Participant Flow|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
314345|NCT01210118|P1|Participant Flow|High Intensity Intervention|"Experimental group participants received a higher intensity intervention, which included: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the 5 Αs (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided."
314346|NCT01210118|O2|Outcome|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
314347|NCT01210118|O1|Outcome|High Intensity Intervention|Experimental group participants received a higher intensity intervention, which included: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the
314348|NCT01210118|O2|Outcome|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
314349|NCT01210118|O1|Outcome|High Intensity Intervention|"Experimental group participants received a higher intensity intervention, which included: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the 5 Αs (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided."
314350|NCT01210118|O2|Outcome|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
314351|NCT01210118|O1|Outcome|High Intensity Intervention|Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the
314352|NCT01210118|O2|Outcome|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
314356|NCT01210079|B3|Baseline|Total|Total of all reporting groups
314357|NCT01210079|B2|Baseline|Placebo|Matched placebo group underwent identical 'titration' as intervention group.
314359|NCT01210079|P2|Participant Flow|Placebo|Matched placebo group underwent identical 'titration' as intervention group.
314360|NCT01210079|P1|Participant Flow|Gabapentin|Gabapentin titrated to 2400 mg daily PO for 5 weeks
314361|NCT01210079|O2|Outcome|Placebo|Matched placebo group underwent identical 'titration' as intervention group.
314362|NCT01210079|O1|Outcome|Gabapentin|Gabapentin titrated to 2400 mg daily PO for 5 weeks
314363|NCT01210079|E2|Reported Event|Placebo|Matched placebo group underwent identical 'titration' as intervention group.
314364|NCT01210079|E1|Reported Event|Gabapentin|Gabapentin titrated to 2400 mg daily PO for 5 weeks
314365|NCT01210001|B4|Baseline|Total|Total of all reporting groups
314366|NCT01210001|B3|Baseline|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
314367|NCT01210001|B2|Baseline|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
314368|NCT01210001|B1|Baseline|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
314369|NCT01210001|P3|Participant Flow|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
314370|NCT01210001|P2|Participant Flow|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
314371|NCT01210001|P1|Participant Flow|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
314372|NCT01210001|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
314373|NCT01210001|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
314374|NCT01210001|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
314375|NCT01210001|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
314376|NCT01210001|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
314377|NCT01210001|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
314378|NCT01210001|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
314379|NCT01210001|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
314380|NCT01210001|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
314381|NCT01210001|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
314382|NCT01210001|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
314383|NCT01210001|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
314384|NCT01210001|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
314385|NCT01210001|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
314386|NCT01210001|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
314387|NCT01210001|E3|Reported Event|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
314388|NCT01210001|E2|Reported Event|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
314389|NCT01210001|E1|Reported Event|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
314390|NCT01209949|B1|Baseline|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
314391|NCT01209949|P1|Participant Flow|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
314392|NCT01209949|O1|Outcome|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
314393|NCT01209949|O1|Outcome|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
314394|NCT01209949|O1|Outcome|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
314395|NCT01209949|E1|Reported Event|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
314396|NCT01209780|B5|Baseline|Total|Total of all reporting groups
314397|NCT01209780|B4|Baseline|Control (9-17 Years)|All subjects received one dose of control TIV (eTIV_f).
314398|NCT01209780|B3|Baseline|TIV (9-17 Years)|All subjects received one dose of investigational TIV.
314399|NCT01209780|B2|Baseline|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of vaccine.
314400|NCT01209780|B1|Baseline|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
314401|NCT01209780|P5|Participant Flow|Control (9-17 Years)|All subjects in this group were non-naive and received one dose of US licensed control vaccine TIVf.
314402|NCT01209780|P4|Participant Flow|TIV (9-17 Years)|All subjects in this group were non-naive and received one dose of investigational TIV.
314403|NCT01209780|P3|Participant Flow|Control (3 to < 4 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination.The non-naive subjects received one dose and naive subjects received two doses of US licensed control vaccine- comparator TIV.
314404|NCT01209780|P2|Participant Flow|Control (4-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of US licensed control vaccine- TIVf.
314405|NCT01209780|P1|Participant Flow|TIV (3-8 Years Old)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
314406|NCT01209780|O4|Outcome|Control (9-17 Years)|All subjects received one dose of control vaccine (TIVf).
314407|NCT01209780|O3|Outcome|TIV (9-17 Years)|All subjects received one dose of investigational TIV.
314408|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
314409|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
314410|NCT01209780|O4|Outcome|Control (9-17 Years)|All subjects received one dose of control vaccine(TIVf).
314411|NCT01209780|O3|Outcome|TIV (9-17 Years)|All subjects received one dose of investigational TIV.
314412|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
314413|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
314414|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to <4 years)] consisted of naive subjects (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) who received two doses of control vaccine. Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received two doses of comparator TIV.
314415|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive subjects (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) who received two doses of investigational TIV.
314416|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to <4 years)] consisted of naive subjects (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) who received two doses of control vaccine. Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received two doses of comparator TIV.
314417|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive subjects (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) who received two doses of investigational TIV.
314418|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
314419|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
314420|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
314421|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
314422|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
314423|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
314424|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
314425|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
314426|NCT01209780|E4|Reported Event|Control (9-17 Years)|All subjects received one dose of control vaccine (TIV_f).
314427|NCT01209780|E3|Reported Event|TIV (9-17 Years)|All subjects received one dose of investigational TIV.
314428|NCT01209780|E2|Reported Event|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
314429|NCT01209780|E1|Reported Event|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
314430|NCT01209767|B1|Baseline|Subjects Receiving Split Body Treatment|"The unit of randomization was the side of the body within each subject to receive either cryolipolysis or subcision.~cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator and then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite~Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle was moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together."
314431|NCT01209767|P1|Participant Flow|Subjects Receiving Split Body Treatment|"The unit of randomization was the side of the body within each subject to receive either cryolipolysis or subcision.~cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator and then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite~Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle was moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together."
314432|NCT01209767|O3|Outcome|Control|Area that received no treatment
314433|NCT01209767|O2|Outcome|Subcision|Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle is moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together.
314434|NCT01209767|O1|Outcome|Cryolipolysis|cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator and then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite
314435|NCT01209767|E3|Reported Event|Control|Nothing was done to the area.
314436|NCT01209767|E2|Reported Event|Subcision|Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle was moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together.
314437|NCT01209767|E1|Reported Event|Cryolipolysis|cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite
314438|NCT01209702|B3|Baseline|Total|Total of all reporting groups
314439|NCT01209702|B2|Baseline|Combined Tocilizumab|Participants randomized in Part 1 and Part 2 to receive intravenous infusions of 4 mg/kg (in Part 2 only) or 8 mg/kg tocilizumab once every 4 weeks.
314440|NCT01209702|B1|Baseline|Combined Placebo|Participants in Part 1 and Part 2 who received intravenous infusions of placebo once every 4 weeks.
314441|NCT01209702|P4|Participant Flow|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314442|NCT01209702|P3|Participant Flow|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314443|NCT01209702|P2|Participant Flow|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
314444|NCT01209702|P1|Participant Flow|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
314445|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
314446|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
314511|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
314447|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314448|NCT01209702|O1|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314449|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314450|NCT01209702|O1|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314451|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks.
314452|NCT01209702|O1|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks.
314453|NCT01209702|O1|Outcome|All Tocilizumab|Participants who received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks in either Part 1 or Part 2, including participants randomized to placebo who switched or escaped to tocilizumab treatment.
314454|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314455|NCT01209702|O1|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
314456|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314457|NCT01209702|O1|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
314458|NCT01209702|O1|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314459|NCT01209702|O1|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314460|NCT01209702|O1|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314461|NCT01209702|O1|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314462|NCT01209702|O1|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314512|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
314513|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
314463|NCT01209702|O4|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314464|NCT01209702|O3|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314465|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
314466|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
314467|NCT01209702|O4|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314468|NCT01209702|O3|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314469|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
314470|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
314471|NCT01209702|O4|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314472|NCT01209702|O3|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314473|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
314474|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
314475|NCT01209702|O4|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314476|NCT01209702|O3|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314477|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
314478|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
314479|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314514|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
314480|NCT01209702|O1|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314481|NCT01209702|O4|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314482|NCT01209702|O3|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314483|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
314484|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
314485|NCT01209702|O4|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314486|NCT01209702|O3|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
314487|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
314488|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
314489|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks.
314490|NCT01209702|O1|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks.
314491|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12.
314492|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12.
314493|NCT01209702|E4|Reported Event|All Tocilizumab|Participants who received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks in either Part 1 or Part 2. This group includes participants randomized to placebo who switched or escaped to tocilizumab treatment for whom adverse events are reported after the start of treatment with tocilizumab.
314494|NCT01209702|E3|Reported Event|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks. AEs reported only until participants escaped or switched to tocilizumab.
314495|NCT01209702|E2|Reported Event|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
314496|NCT01209702|E1|Reported Event|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
314497|NCT01209689|B3|Baseline|Total|Total of all reporting groups
314498|NCT01209689|B2|Baseline|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.
314499|NCT01209689|B1|Baseline|Tocilizumab 4 or 8 mg/kg|Patients received tocilizumab 4 or 8 mg/kg intravenously every 4 weeks for 24 weeks.
314500|NCT01209689|P2|Participant Flow|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.
314501|NCT01209689|P1|Participant Flow|Tocilizumab 4 or 8 mg/kg|Patients received tocilizumab 4 or 8 mg/kg intravenously every 4 weeks for 24 weeks.
314502|NCT01209689|O2|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.
314503|NCT01209689|O1|Outcome|Tocilizumab 4 or 8 mg/kg|Patients received tocilizumab 4 or 8 mg/kg intravenously every 4 weeks for 24 weeks.
314504|NCT01209689|E2|Reported Event|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.
314505|NCT01209689|E1|Reported Event|Tocilizumab|Patients randomized to tocilizumab who received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks for 24 weeks and patients randomized to placebo who switched or escaped to tocilizumab treatment.
314506|NCT01209624|B1|Baseline|Xalatan®|Once daily as 1 drop (topical application) in the evening
314507|NCT01209624|P1|Participant Flow|Xalatan®|Once daily as 1 drop (topical application) in the evening
314515|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
314516|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
314517|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
314518|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
314519|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
314520|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
314521|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
314522|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
314523|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
314524|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
314525|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
314526|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
314527|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
314528|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
314529|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
314530|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
314531|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
314532|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
314533|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
314534|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
314535|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
314536|NCT01209624|E1|Reported Event|Xalatan®|Once daily as 1 drop (topical application) in the evening
314537|NCT01209598|B3|Baseline|Total|Total of all reporting groups
314538|NCT01209598|B2|Baseline|Palbociclib 125mg|"This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.~Palbociclib 125mg: Schedule 3/1: Palbociclib 125mg given once daily by mouth for 21 consecutive days, followed by 7 days of rest. A cycle will be defined as 28 days. Following the positive results of the study, a new Expansion Cohort has been added to permit enrollment of up to 20 additional patients."
314539|NCT01209598|B1|Baseline|Palbociclib 200mg|"This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.~Palbociclib 200mg: Schedule 2/1: Palbociclib 200mg given once daily by mouth for 14 consecutive days, followed by 7 days of rest. A cycle will be defined as 21 days."
314540|NCT01209598|P2|Participant Flow|Palbociclib 125mg|"This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.~Palbociclib 125mg: Schedule 3/1: Palbociclib 125mg given once daily by mouth for 21 consecutive days, followed by 7 days of rest. A cycle will be defined as 28 days. Following the positive results of the study, a new Expansion Cohort has been added to permit enrollment of up to 20 additional patients."
314541|NCT01209598|P1|Participant Flow|Palbociclib 200mg|"This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.~Palbociclib 200mg: Schedule 2/1: Palbociclib 200mg given once daily by mouth for 14 consecutive days, followed by 7 days of rest. A cycle will be defined as 21 days."
314542|NCT01209598|O2|Outcome|Palbociclib 125mg|"This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.~Palbociclib 125mg: Schedule 3/1: Palbociclib 125mg given once daily by mouth for 21 consecutive days, followed by 7 days of rest. A cycle will be defined as 28 days. Following the positive results of the study, a new Expansion Cohort has been added to permit enrollment of up to 20 additional patients.~Expansion Cohort: Dosed as per Schedule 3/1. Capsules should be taken with food."
314543|NCT01209598|O1|Outcome|Palbociclib 200mg|"This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.~Palbociclib 200mg: Schedule 2/1: Palbociclib 200mg given once daily by mouth for 14 consecutive days, followed by 7 days of rest. A cycle will be defined as 21 days."
314544|NCT01209598|O2|Outcome|Palbociclib 125mg|"This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.~Palbociclib 125mg: Schedule 3/1: Palbociclib 125mg given once daily by mouth for 21 consecutive days, followed by 7 days of rest. A cycle will be defined as 28 days. Following the positive results of the study, a new Expansion Cohort has been added to permit enrollment of up to 20 additional patients."
314545|NCT01209598|O1|Outcome|Palbociclib 200mg|"This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.~Palbociclib 200mg: Schedule 2/1: Palbociclib 200mg given once daily by mouth for 14 consecutive days, followed by 7 days of rest. A cycle will be defined as 21 days."
314546|NCT01209598|E2|Reported Event|Palbociclib 125mg|"This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.~Palbociclib 125mg: Schedule 3/1: Palbociclib 125mg given once daily by mouth for 21 consecutive days, followed by 7 days of rest. A cycle will be defined as 28 days. Following the positive results of the study, a new Expansion Cohort has been added to permit enrollment of up to 20 additional patients."
314560|NCT01209286|O1|Outcome|Blinatumomab|All participants who received blinatumomab.
314561|NCT01209286|O1|Outcome|Blinatumomab|All participants who received blinatumomab.
314547|NCT01209598|E1|Reported Event|Palbociclib 200mg|"This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.~Palbociclib 200mg: Schedule 2/1: Palbociclib 200mg given once daily by mouth for 14 consecutive days, followed by 7 days of rest. A cycle will be defined as 21 days."
314548|NCT01209520|B1|Baseline|Adjuvant Chemotherapy + Vidaza|"Cisplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Carboplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Paclitaxel: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Vidaza: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles"
314549|NCT01209520|P1|Participant Flow|Adjuvant Chemotherapy + Vidaza|"Cisplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Carboplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Paclitaxel: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Vidaza: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles"
314550|NCT01209520|O1|Outcome|Adjuvant Chemotherapy + Vidaza|"Cisplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Carboplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Paclitaxel: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Vidaza: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles"
314551|NCT01209520|O1|Outcome|Adjuvant Chemotherapy + Vidaza|"Cisplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Carboplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Paclitaxel: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Vidaza: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles"
314552|NCT01209520|E1|Reported Event|Adjuvant Chemotherapy + Vidaza|"Cisplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Carboplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Paclitaxel: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Vidaza: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles"
314553|NCT01209286|B4|Baseline|Total|Total of all reporting groups
314554|NCT01209286|B3|Baseline|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
314555|NCT01209286|B2|Baseline|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
314556|NCT01209286|B1|Baseline|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
314557|NCT01209286|P3|Participant Flow|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
314558|NCT01209286|P2|Participant Flow|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
314559|NCT01209286|P1|Participant Flow|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
314562|NCT01209286|O3|Outcome|Blinatumomab 30 μg|Participants receiving blinatumomab 30 μg/m²/day.
314563|NCT01209286|O2|Outcome|Blinatumomab 15 μg|Participants receiving blinatumomab 15 μg/m²/day.
314564|NCT01209286|O1|Outcome|Blinatumomab 5 μg|Participants receiving blinatumomab 5 μg/m²/day.
314565|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
314566|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
314567|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
314568|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
314569|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
314570|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
314571|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
314572|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
314573|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
314574|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
314575|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
314576|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
314577|NCT01209286|O4|Outcome|Blinatumimab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
314578|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
314579|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
314580|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
314581|NCT01209286|O4|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
314582|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
314583|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
314584|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
314585|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
314586|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
314648|NCT01209195|O5|Outcome|Part 2: Cohort 3|"MM-121 40mg/kg IV QOW~Paclitaxel: 80 mg/m2 weekly IV"
314587|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
314588|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
314589|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
314590|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
314591|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
314592|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
314593|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
314594|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
314595|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
314596|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
314597|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
314598|NCT01209286|O3|Outcome|ABlinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
314599|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
314600|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
314601|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
314602|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
314603|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
314604|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
314605|NCT01209286|E4|Reported Event|Blinatumomab Overall|All participants who received blinatumomab by continuous intravenous infusion during the core study.
314606|NCT01209286|E3|Reported Event|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
314607|NCT01209286|E2|Reported Event|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
314608|NCT01209286|E1|Reported Event|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
314609|NCT01209260|B3|Baseline|Total|Total of all reporting groups
314610|NCT01209260|B2|Baseline|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
314649|NCT01209195|O4|Outcome|Part 2: Expansion Cohort 2|"MM-121 20 mg/kg IV loading dose followed by 12 mg/kg IV QW maintenance dose~Paclitaxel: 80 mg/m2 weekly IV"
314611|NCT01209260|B1|Baseline|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
314612|NCT01209260|P2|Participant Flow|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
314613|NCT01209260|P1|Participant Flow|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
314614|NCT01209260|O2|Outcome|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle
314615|NCT01209260|O1|Outcome|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle
314616|NCT01209260|O2|Outcome|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle
314617|NCT01209260|O1|Outcome|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle
314618|NCT01209260|O2|Outcome|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
314619|NCT01209260|O1|Outcome|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
314620|NCT01209260|O2|Outcome|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
314621|NCT01209260|O1|Outcome|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
314622|NCT01209260|E2|Reported Event|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
314623|NCT01209260|E1|Reported Event|Radiofrequency Energy Needle (RF)|Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
314624|NCT01209195|B3|Baseline|Total|Total of all reporting groups
314625|NCT01209195|B2|Baseline|MM-121 + Paclitaxel: Expansion Cohort|MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
314626|NCT01209195|B1|Baseline|MM-121 + Paclitaxel: Dose Escalation|"MM-121 plus Paclitaxel: Cohort 1:~MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV~Cohort 2:~MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV~Intermediate doses between cohorts 1 and 2 may also be considered."
314627|NCT01209195|P6|Participant Flow|Part 2: Cohort 4|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest~Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"
314628|NCT01209195|P5|Participant Flow|Part 2: Cohort 3|"MM-121 40mg/kg IV QOW~Paclitaxel: 80 mg/m2 weekly IV"
314629|NCT01209195|P4|Participant Flow|Part 2: Expansion Cohort 2|"MM-121 20 mg/kg IV loading dose followed by 12 mg/kg IV QW maintenance dose~Paclitaxel: 80 mg/m2 weekly IV"
314630|NCT01209195|P3|Participant Flow|Part 2: Expansion Cohort 1|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
314631|NCT01209195|P2|Participant Flow|Part 1: Dose Escalation: Cohort 2|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
314632|NCT01209195|P1|Participant Flow|Part 1: Dose Escalation: Cohort 1|MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
314633|NCT01209195|O6|Outcome|Part 2: Cohort 4|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest~Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"
314634|NCT01209195|O5|Outcome|Part 2: Cohort 3|"MM-121 40mg/kg IV QOW~Paclitaxel: 80 mg/m2 weekly IV"
314635|NCT01209195|O4|Outcome|Part 2: Expansion Cohort 2|"MM-121 20 mg/kg IV loading dose followed by 12 mg/kg IV QW maintenance dose~Paclitaxel: 80 mg/m2 weekly IV"
314636|NCT01209195|O3|Outcome|Part 2: Expansion Cohort 1|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
314637|NCT01209195|O2|Outcome|Part 1: Dose Escalation: Cohort 2|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
314638|NCT01209195|O1|Outcome|Part 1: Dose Escalation: Cohort 1|MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
314639|NCT01209195|O4|Outcome|MM-121 + Paclitaxel: 40/20 mg/kg + Rest Week|"MM-121: 40 mg/kg loading dose followed by seven 20mg/kg weekly doses and a rest week. This administration schedule spans two cycles and repeats for each subsequent 2-cycle unit.~Paclitaxel: 80 mg/m2"
314640|NCT01209195|O3|Outcome|MM-121 + Paclitaxel: 40 mg/kg Q2W|MM-121: 40 mg/kg Q2W Paclitaxel: 80 mg/m2
314641|NCT01209195|O2|Outcome|MM-121 + Paclitaxel: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Paclitaxel: 80 mg/m2
314642|NCT01209195|O1|Outcome|MM-121 + Paclitaxel: 20/12 mg/kg|MM-121: 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Paclitaxel: 80 mg/m2
314643|NCT01209195|O4|Outcome|MM-121 + Paclitaxel: 40/20 mg/kg + Rest Week|"MM-121: 40 mg/kg loading dose followed by seven 20mg/kg weekly doses and a rest week. This administration schedule spans two cycles and repeats for each subsequent 2-cycle unit.~Paclitaxel: 80 mg/m2"
314644|NCT01209195|O3|Outcome|MM-121 + Paclitaxel: 40 mg/kg Q2W|MM-121: 40 mg/kg Q2W Paclitaxel: 80 mg/m2
314645|NCT01209195|O2|Outcome|MM-121 + Paclitaxel: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Paclitaxel: 80 mg/m2
314646|NCT01209195|O1|Outcome|MM-121 + Paclitaxel: 20/12 mg/kg|MM-121: 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Paclitaxel: 80 mg/m2
314647|NCT01209195|O6|Outcome|Part 2: Cohort 4|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest~Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"
314650|NCT01209195|O3|Outcome|Part 2: Expansion Cohort 1|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
314651|NCT01209195|O2|Outcome|Part 1: Dose Escalation: Cohort 2|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
314652|NCT01209195|O1|Outcome|Part 1: Dose Escalation: Cohort 1|MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
314653|NCT01209195|O2|Outcome|Part 2: Expansion Cohorts|Additional exploratory doses of MM-121 and paclitaxel
314654|NCT01209195|O1|Outcome|Part 1: Dose Escalation|Escalating doses of MM-121 and paclitaxel
314655|NCT01209195|O2|Outcome|Part 2: Expansion Cohorts|Additional exploratory doses of MM-121 and paclitaxel
314656|NCT01209195|O1|Outcome|Part 1: Dose Escalation|Escalating doses of MM-121 and paclitaxel
314657|NCT01209195|O6|Outcome|Part 2: Cohort 4|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest~Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"
314658|NCT01209195|O5|Outcome|Part 2: Cohort 3|"MM-121 40mg/kg IV QOW~Paclitaxel: 80 mg/m2 weekly IV"
314659|NCT01209195|O4|Outcome|Part 2: Expansion Cohort 2|"MM-121 20 mg/kg IV loading dose followed by 12 mg/kg IV QW maintenance dose~Paclitaxel: 80 mg/m2 weekly IV"
314660|NCT01209195|O3|Outcome|Part 2: Expansion Cohort 1|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
314661|NCT01209195|O2|Outcome|Part 1: Dose Escalation: Cohort 2|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
314662|NCT01209195|O1|Outcome|Part 1: Dose Escalation: Cohort 1|MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
314663|NCT01209195|E2|Reported Event|MM-121 + Paclitaxel: Expansion Cohort|"Cohort 1:~MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV~Cohort 2:~MM-121 20 mg/kg IV loading dose x followed by 12 mg/kg IV QW maintenance dose Paclitaxel: 80 mg/m2 weekly IV~Cohort 3:~MM-121 40mg/kg IV QOW Paclitaxel: 80 mg/m2 weekly IV~Cohort 4:~MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"
314664|NCT01209195|E1|Reported Event|MM-121 + Paclitaxel: Dose Escalation|"Cohort 1:~MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV~Cohort 2:~MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV"
314665|NCT01209143|B3|Baseline|Total|Total of all reporting groups
314666|NCT01209143|B2|Baseline|Vismodegib + Oral Contraceptive|"Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Norethindrone/ethinyl estradiol: Norethindrone/ethinyl estradiol was supplied in tablets."
314667|NCT01209143|B1|Baseline|Vismodegib + Rosiglitazone|"Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Rosiglitazone: Rosiglitazone was supplied in tablets."
314668|NCT01209143|P2|Participant Flow|Vismodegib + Oral Contraceptive|"Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Norethindrone/ethinyl estradiol: Norethindrone/ethinyl estradiol was supplied in tablets."
314669|NCT01209143|P1|Participant Flow|Vismodegib + Rosiglitazone|"Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Rosiglitazone: Rosiglitazone was supplied in tablets."
314670|NCT01209143|O1|Outcome|Vismodegib + Oral Contraceptive|"Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Norethindrone/ethinyl estradiol: Norethindrone/ethinyl estradiol was supplied in tablets."
314671|NCT01209143|O1|Outcome|Vismodegib + Oral Contraceptive|"Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Norethindrone/ethinyl estradiol: Norethindrone/ethinyl estradiol was supplied in tablets."
314672|NCT01209143|O1|Outcome|Vismodegib + Rosiglitazone|"Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Rosiglitazone: Rosiglitazone was supplied in tablets."
314673|NCT01209143|O1|Outcome|Vismodegib + Rosiglitazone|"Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Rosiglitazone: Rosiglitazone was supplied in tablets."
314758|NCT01208961|O1|Outcome|Epanova (Low-Fat Period)|Single dose of Epanova (omefas), 4*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
314674|NCT01209143|E2|Reported Event|Vismodegib + Oral Contraceptive|"Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Norethindrone/ethinyl estradiol: Norethindrone/ethinyl estradiol was supplied in tablets."
314675|NCT01209143|E1|Reported Event|Vismodegib + Rosiglitazone|"Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Rosiglitazone: Rosiglitazone was supplied in tablets."
314676|NCT01209078|B3|Baseline|Total|Total of all reporting groups
314677|NCT01209078|B2|Baseline|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314678|NCT01209078|B1|Baseline|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314679|NCT01209078|P2|Participant Flow|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314680|NCT01209078|P1|Participant Flow|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 milliliter (mL) of water or liquid.
314681|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314682|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314683|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314684|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314685|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314686|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314687|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314688|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314689|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314690|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314691|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314692|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314693|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314694|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314695|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314696|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314697|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314698|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314699|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314700|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314701|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314702|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314703|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314704|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314705|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314706|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314707|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314708|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314709|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314710|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314711|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314712|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314713|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314714|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314715|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314759|NCT01208961|O2|Outcome|Lovaza (Low-Fat Period)|Single dose of Lovaza (omega-3-acid ethyl esters), 4*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
314716|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314717|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314718|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314719|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314720|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314721|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314722|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314723|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314724|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314725|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314726|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314727|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314728|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314729|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314730|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314731|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314732|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314733|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314734|NCT01209078|O2|Outcome|Linezolid 600 mg|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314735|NCT01209078|O1|Outcome|GSK1322322 1500 mg|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314736|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314760|NCT01208961|O1|Outcome|Epanova (Low-Fat Period)|Single dose of Epanova (omefas), 4*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
314737|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314738|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314739|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314740|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314741|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314742|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314743|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314744|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314745|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314746|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314747|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314748|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314749|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314750|NCT01209078|O2|Outcome|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314751|NCT01209078|O1|Outcome|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314752|NCT01209078|E2|Reported Event|Linezolid 600 mg BID|Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314753|NCT01209078|E1|Reported Event|GSK1322322 1500 mg BID|Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
314754|NCT01208961|B1|Baseline|All Subjects|All subjects received both Epanova (E) and Lovaza (L), and both under fasted and fed conditions. Subjects were randomized 1:1 to one of the following treatment period sequences: ELEL or LELE.
314755|NCT01208961|P2|Participant Flow|Lovaza-Epanova-Lovaza-Epanova|Lovaza (4 g) and Epanova (4 g) : Single dose of Lovaza (omega-3-acid ethyl esters), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Epanova (omefas; corresponds to omega-3 carboxylic acids), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters,4x1g capsules, taken with high-fat meals, 7 day washout followed by single dose of Epanova (omefas),4x1g capsules, taken with high-fat meals
314756|NCT01208961|P1|Participant Flow|Epanova-Lovaza-Epanova-Lovaza|Epanova (4 g) and Lovaza (4 g) : Single dose of Epanova (omefas; corresponds to omega-3 carboxylic acids), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Epanova (omefas), 4x1g capsules, taken with high-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters, 4x1g capsules, taken with high-fat meals
314757|NCT01208961|O2|Outcome|Lovaza (Low-Fat Period)|Single dose of Lovaza (omega-3-acid ethyl esters), 4*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
314761|NCT01208961|O2|Outcome|Lovaza (Low-Fat Period)|Single dose of Lovaza (omega-3-acid ethyl esters), 4*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
314762|NCT01208961|O1|Outcome|Epanova (Low-Fat Period)|Single dose of Epanova (omefas), 4*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
314763|NCT01208961|E1|Reported Event|All Subjects|All subjects received both Epanova (E) and Lovaza (L), and both under fasted and fed conditions. Subjects were randomized 1:1 to one of the following treatment period sequences: ELEL or LELE.
314764|NCT01208870|B3|Baseline|Total|Total of all reporting groups
314765|NCT01208870|B2|Baseline|Nutrition Education Control|"Traditional family based weight control program, without components of habituation theory incorporated.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group."
314766|NCT01208870|B1|Baseline|Experimental Group|"Traditional family based weight control program with components from habituation theory incorporated into the treatment.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group."
314767|NCT01208870|P2|Participant Flow|Nutrition Education Control|"Traditional family based weight control program, without components of habituation theory incorporated.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group."
314768|NCT01208870|P1|Participant Flow|Experimental Group|"Traditional family based weight control program with components from habituation theory incorporated into the treatment.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group. Experimental"
314769|NCT01208870|O2|Outcome|Nutrition Education Control|"Traditional family based weight control program, without components of habituation theory incorporated.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group."
314770|NCT01208870|O1|Outcome|Experimental Group|"Traditional family based weight control program with components from habituation theory incorporated into the treatment.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group."
314771|NCT01208870|O2|Outcome|Nutrition Education Control|"Traditional family based weight control program, without components of habituation theory incorporated.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group."
314772|NCT01208870|O1|Outcome|Experimental Group|"Traditional family based weight control program with components from habituation theory incorporated into the treatment.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group."
314773|NCT01208870|O2|Outcome|Nutrition Education Control|"Traditional family based weight control program, without components of habituation theory incorporated.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group."
314774|NCT01208870|O1|Outcome|Experimental Group|"Traditional family based weight control program with components from habituation theory incorporated into the treatment.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group."
314775|NCT01208870|O2|Outcome|Nutrition Education Control|"Traditional family based weight control program, without components of habituation theory incorporated.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group."
314776|NCT01208870|O1|Outcome|Experimental Group|"Traditional family based weight control program with components from habituation theory incorporated into the treatment.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group."
314777|NCT01208870|O2|Outcome|Nutrition Education Control|"Traditional family based weight control treatment program, without components from habituation theory incorporated into the treatment. Families meet weekly for 12 weeks, then by-weekly for 1 month and 1 monthly session for a total of 15 sessions.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group."
314778|NCT01208870|O1|Outcome|Experimental Group|"Traditional family based weight control treatment program with components from habituation theory incorporated into the treatment. Families meet weekly for 12 weeks, then by-weekly for 1 month and 1 monthly session for a total of 15 sessions.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group."
314779|NCT01208870|O2|Outcome|Nutrition Education Control|"Traditional family based weight control program, without components of habituation theory incorporated.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group."
314780|NCT01208870|O1|Outcome|Experimental Group|"Traditional family based weight control program with components from habituation theory incorporated into the treatment.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group."
314781|NCT01208870|E2|Reported Event|Nutrition Education Control|"Traditional family based weight control program, without components of habituation theory incorporated.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group."
314849|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-03049423 3 mg once daily for 90 days.
314782|NCT01208870|E1|Reported Event|Experimental Group|"Traditional family based weight control program with components from habituation theory incorporated into the treatment.~Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group."
314783|NCT01208415|B1|Baseline|Zenith® Iliac Branch System|Zenith® Branch Endovascular Graft-Iliac Bifurcation System is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the ConnectSX™.
314784|NCT01208415|P1|Participant Flow|Zenith® Iliac Branch System|Zenith® Branch Endovascular Graft-Iliac Bifurcation System is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the ConnectSX™.
314785|NCT01208415|O1|Outcome|Device Implant|Endovascular repair for aortoiliac or iliac aneurysms.: Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Zenith® Connection Endovascular Covered Stent/ConnectSX™ and the Zenith® Flex AAA Endovascular Graft.
314786|NCT01208415|E1|Reported Event|Zenith® Iliac Branch System|Zenith® Branch Endovascular Graft-Iliac Bifurcation System is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the ConnectSX™.
314787|NCT01208402|B3|Baseline|Total|Total of all reporting groups
314788|NCT01208402|B2|Baseline|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
314789|NCT01208402|B1|Baseline|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
314790|NCT01208402|P2|Participant Flow|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
314791|NCT01208402|P1|Participant Flow|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
314792|NCT01208402|O2|Outcome|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
314793|NCT01208402|O1|Outcome|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
314794|NCT01208402|O2|Outcome|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
314795|NCT01208402|O1|Outcome|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
314796|NCT01208402|O2|Outcome|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
314797|NCT01208402|O1|Outcome|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
314798|NCT01208402|O2|Outcome|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
314799|NCT01208402|O1|Outcome|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
314800|NCT01208402|O2|Outcome|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
314801|NCT01208402|O1|Outcome|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
314802|NCT01208402|O2|Outcome|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
314803|NCT01208402|O1|Outcome|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
314804|NCT01208402|E2|Reported Event|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
314805|NCT01208402|E1|Reported Event|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
314806|NCT01208337|B1|Baseline|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
314807|NCT01208337|P1|Participant Flow|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
314808|NCT01208337|O1|Outcome|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
314809|NCT01208337|O1|Outcome|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
314810|NCT01208337|O1|Outcome|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
314811|NCT01208337|O1|Outcome|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
314812|NCT01208337|O1|Outcome|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
314813|NCT01208337|E1|Reported Event|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
314814|NCT01208233|B7|Baseline|Total|Total of all reporting groups
314815|NCT01208233|B6|Baseline|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
314816|NCT01208233|B5|Baseline|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314817|NCT01208233|B4|Baseline|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
314818|NCT01208233|B3|Baseline|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
314819|NCT01208233|B2|Baseline|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
314820|NCT01208233|B1|Baseline|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
314821|NCT01208233|P6|Participant Flow|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
314822|NCT01208233|P5|Participant Flow|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314823|NCT01208233|P4|Participant Flow|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
314824|NCT01208233|P3|Participant Flow|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
314825|NCT01208233|P2|Participant Flow|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
314826|NCT01208233|P1|Participant Flow|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
314827|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
314828|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314829|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-03049423 6 mg once daily for 90 days.
314830|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314831|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-03049423 3 mg once daily for 90 days.
314832|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
314833|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
314834|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
314835|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-03049423 6 mg once daily for 90 days.
314836|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314837|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-03049423 3 mg once daily for 90 days.
314838|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
314839|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
314840|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
314841|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-03049423 6 mg once daily for 90 days.
314842|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314843|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-03049423 3 mg once daily for 90 days.
314844|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
314845|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
314846|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
314847|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-03049423 6 mg once daily for 90 days.
314848|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314850|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
314851|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
314852|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
314853|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-03049423 6 mg once daily for 90 days.
314854|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314855|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-03049423 3 mg once daily for 90 days.
314856|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
314857|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
314858|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
314859|NCT01208233|O3|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314860|NCT01208233|O2|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
314861|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
314862|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
314863|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314864|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
314865|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314866|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
314867|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314868|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
314869|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314870|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
314871|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314872|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
314873|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314874|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
314875|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314876|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
314877|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314878|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
314879|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314880|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
314881|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314882|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
314883|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314884|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
314885|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314886|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
314887|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314888|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
314889|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314890|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
314891|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314892|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
314893|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314894|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
314895|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314896|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
314897|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
314898|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
314899|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
314900|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
314901|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314902|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
314903|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
314904|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
314905|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
314906|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
314907|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314908|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
314909|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
314910|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
314911|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
314912|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
314913|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314914|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
314915|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
314916|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
314917|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
314918|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
314919|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314920|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
314921|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
314922|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
314923|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
314924|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
314925|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314926|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
314927|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
314928|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
314929|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
314930|NCT01208233|E6|Reported Event|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
314931|NCT01208233|E5|Reported Event|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
314932|NCT01208233|E4|Reported Event|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
314933|NCT01208233|E3|Reported Event|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
314934|NCT01208233|E2|Reported Event|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
314935|NCT01208233|E1|Reported Event|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
314936|NCT01208220|B3|Baseline|Total|Total of all reporting groups
314937|NCT01208220|B2|Baseline|Santyl Ointment and NPWT|"Enzymatic debriding ointment used in conjunction with negative pressure wound therapy~Collagenase Santyl : Topical enzyme applied to wound tissue"
314938|NCT01208220|B1|Baseline|Negative Pressure Wound Therapy|"NPWT alone for treatment of pressure ulcer~NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly"
314939|NCT01208220|P2|Participant Flow|Santyl Ointment and NPWT|"Enzymatic debriding ointment used in conjunction with negative pressure wound therapy~Collagenase Santyl : Topical enzyme applied to wound tissue"
314940|NCT01208220|P1|Participant Flow|Negative Pressure Wound Therapy|"NPWT alone for treatment of pressure ulcer~NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly"
314941|NCT01208220|O2|Outcome|Santyl Ointment and NPWT|"Enzymatic debriding ointment used in conjunction with negative pressure wound therapy~Collagenase Santyl : Topical enzyme applied to wound tissue"
314942|NCT01208220|O1|Outcome|Negative Pressure Wound Therapy|"NPWT alone for treatment of pressure ulcer~NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly"
314943|NCT01208220|O2|Outcome|Santyl Ointment and NPWT|"Enzymatic debriding ointment used in conjunction with negative pressure wound therapy~Collagenase Santyl : Topical enzyme applied to wound tissue"
314944|NCT01208220|O1|Outcome|Negative Pressure Wound Therapy|"NPWT alone for treatment of pressure ulcer~NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly"
314945|NCT01208220|E2|Reported Event|Santyl Ointment and NPWT|"Enzymatic debriding ointment used in conjunction with negative pressure wound therapy~Collagenase Santyl : Topical enzyme applied to wound tissue"
314946|NCT01208220|E1|Reported Event|Negative Pressure Wound Therapy|"NPWT alone for treatment of pressure ulcer~NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly"
314947|NCT01208207|B4|Baseline|Total|Total of all reporting groups
314948|NCT01208207|B3|Baseline|Naproxen 1000 mg|Naproxen 500 mg oral tablet twice daily
314949|NCT01208207|B2|Baseline|Etoricoxib 90 mg|Etoricoxib 90 mg once daily
314950|NCT01208207|B1|Baseline|Etoricoxib 60 mg|Etoricoxib 60 mg oral tablet once daily
314951|NCT01208207|P7|Participant Flow|Naproxen 1000 mg (Part II)|A continuation of the naproxen 500 mg oral tablet twice daily for 20 weeks (Part II)
314952|NCT01208207|P6|Participant Flow|Etoricoxib 90 mg / 90 mg (Part II)|A continuation of the etoricoxib 90 mg oral tablet once daily for 20 weeks (Part II)
314953|NCT01208207|P5|Participant Flow|Etoricoxib 60 mg / 90 mg (Part II)|An increase of etoricoxib to 90 mg for 20 weeks (Part II)
314954|NCT01208207|P4|Participant Flow|Etoricoxib 60 mg / 60 mg (Part II)|A continuation of the etoricoxib 60 mg oral tablet once daily for 20 weeks (Part II)
314955|NCT01208207|P3|Participant Flow|Naproxen 1000 mg (Part I)|Naproxen 500 mg oral tablet twice daily for 6 weeks
314956|NCT01208207|P2|Participant Flow|Etoricoxib 90 mg (Part I)|Etoricoxib 90 mg oral tablet once daily for 6 weeks
314957|NCT01208207|P1|Participant Flow|Etoricoxib 60 mg (Part I)|Etoricoxib 60 mg oral tablet once daily for 6 weeks
314958|NCT01208207|O7|Outcome|Naproxen 1000 mg (Part II)|A continuation of the naproxen 500 mg oral tablet twice daily for 20 weeks (Part II)
314959|NCT01208207|O6|Outcome|Etoricoxib 90 mg / 90 mg (Part II)|A continuation of the etoricoxib 90 mg oral tablet once daily for 20 weeks (Part II)
314960|NCT01208207|O5|Outcome|Etoricoxib 60 mg / 90 mg (Part II)|An increase of etoricoxib to 90 mg for 20 weeks (Part II)
314961|NCT01208207|O4|Outcome|Etoricoxib 60 mg / 60 mg (Part II)|A continuation of the etoricoxib 60 mg oral tablet once daily for 20 weeks (Part II)
314962|NCT01208207|O3|Outcome|Naproxen 1000 mg (Part I)|Naproxen 500 mg oral tablet twice daily for 6 weeks
314963|NCT01208207|O2|Outcome|Etoricoxib 90 mg (Part I)|Etoricoxib 90 mg oral tablet once daily for 6 weeks
314964|NCT01208207|O1|Outcome|Etoricoxib 60 mg (Part I)|Etoricoxib 60 mg oral tablet once daily for 6 weeks
314965|NCT01208207|O2|Outcome|Etoricoxib 60 mg / 60 mg|Etoricoxib 60 mg in Part I and Etoricoxib 60 mg in Part II
314966|NCT01208207|O1|Outcome|Etoricoxib 60 mg/ 90 mg|Etoricoxib 60 mg in Part I and Etoricoxib 90 mg in Part II
314967|NCT01208207|O2|Outcome|Etoricoxib 60 mg|Etoricoxib 60 mg oral tablet once daily for 6 weeks
314968|NCT01208207|O1|Outcome|Etoricoxib 90 mg|Etoricoxib 90 mg oral tablet once daily for 6 weeks
314969|NCT01208207|O2|Outcome|Naproxen 1000 mg|Naproxen 500 mg oral tablet twice daily for 6 weeks
314970|NCT01208207|O1|Outcome|Etoricoxib 60 mg|Etoricoxib 60 mg oral tablet once daily for 6 weeks
314971|NCT01208207|O2|Outcome|Naproxen 1000 mg|Naproxen 500 mg oral tablet twice daily for 6 weeks
314972|NCT01208207|O1|Outcome|Etoricoxib 90 mg|Etoricoxib 90 mg oral tablet once daily for 6 weeks
314973|NCT01208207|E7|Reported Event|Naproxen 1000 mg|Participants who received at least one dose of Naproxen 1000 mg in Part I, but no drug in Part II.
314974|NCT01208207|E6|Reported Event|Etoricoxib 90 mg|Participants who received at least one dose of Etoricoxib 90 mg in Part I, but no drug in Part II.
314975|NCT01208207|E5|Reported Event|Etoricoxib 60 mg|Participants who received at least one dose of Etoricoxib 60 mg in Part I, but no drug in Part II.
314976|NCT01208207|E4|Reported Event|Naproxen 1000 mg / Naproxen 1000 mg|Participants who received Naproxen 1000 mg in Part I and at least one dose of Naproxen 1000 mg in Part II.
314977|NCT01208207|E3|Reported Event|Etoricoxib 90 mg / Etoricoxib 90 mg|Participants who received Etoricoxib 90 mg in Part I and at least one dose of Etoricoxib 90 mg in Part II.
314978|NCT01208207|E2|Reported Event|Etoricoxib 60 mg / Etoricoxib 90 mg|Participants who received Etoricoxib 60 mg in Part I and at least one dose of Etoricoxib 90 mg in Part II.
314979|NCT01208207|E1|Reported Event|Etoricoxib 60 mg / Etoricoxib 60 mg|Participants who received Etoricoxib 60 mg in Part I and at least one dose of Etoricoxib 60 mg in Part II.
314980|NCT01208181|B4|Baseline|Total|Total of all reporting groups
314981|NCT01208181|B3|Baseline|Placebo|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
314982|NCT01208181|B2|Baseline|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
314983|NCT01208181|B1|Baseline|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
314984|NCT01208181|P5|Participant Flow|Placebo|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
314985|NCT01208181|P4|Participant Flow|Etoricoxib 60/Etoricoxib 90mg|The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
314986|NCT01208181|P3|Participant Flow|Etoricoxib 60 mg/Etoricoxib 60 mg|The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence received etoricoxib tablets 60 mg administered orally once daily in Part 1 and Part 2 of the study.
314987|NCT01208181|P2|Participant Flow|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
314988|NCT01208181|P1|Participant Flow|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
314989|NCT01208181|O5|Outcome|Placebo - Part 1|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
314990|NCT01208181|O4|Outcome|Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
314991|NCT01208181|O3|Outcome|Etoricoxib 60mg/Etoricoxib 60mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 and Part 2 of the study.
314992|NCT01208181|O2|Outcome|Etoricoxib 90 mg - Part 1|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
314993|NCT01208181|O1|Outcome|Etoricoxib 60 mg - Part 1|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
314994|NCT01208181|O5|Outcome|Placebo - Part 1|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
316486|NCT01203072|O1|Outcome|DU-176b 5 mg|DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks
314995|NCT01208181|O4|Outcome|Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
314996|NCT01208181|O3|Outcome|Etoricoxib 60mg/Etoricoxib 60mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 and Part 2 of the study.
314997|NCT01208181|O2|Outcome|Etoricoxib 90 mg - Part 1|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
314998|NCT01208181|O1|Outcome|Etoricoxib 60 mg - Part 1|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
314999|NCT01208181|O2|Outcome|Etoricoxib 60 mg/Etoricoxib 90 mg|The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 60 mg tablets administered orally once daily in Part 1 and etoricoxib 90 mg tablets Part 2 of the study.
315000|NCT01208181|O1|Outcome|Etoricoxib 60 mg/Etoricoxib 60 mg|The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib 60 mg tablets administered orally once daily in Part 1 and Part 2 of the study.
315001|NCT01208181|O2|Outcome|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
315002|NCT01208181|O1|Outcome|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
315003|NCT01208181|O2|Outcome|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
315004|NCT01208181|O1|Outcome|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
315005|NCT01208181|O3|Outcome|Placebo|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
315006|NCT01208181|O2|Outcome|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
315007|NCT01208181|O1|Outcome|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
315008|NCT01208181|O3|Outcome|Placebo|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
315009|NCT01208181|O2|Outcome|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
315010|NCT01208181|O1|Outcome|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
315011|NCT01208181|E5|Reported Event|Placebo - Part 1|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
315012|NCT01208181|E4|Reported Event|Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
315013|NCT01208181|E3|Reported Event|Etoricoxib 60mg/Etoricoxib 60mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 and Part 2 of the study.
315014|NCT01208181|E2|Reported Event|Etoricoxib 90 mg - Part 1|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
315015|NCT01208181|E1|Reported Event|Etoricoxib 60 mg - Part 1|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
315016|NCT01207934|B4|Baseline|Total|Total of all reporting groups
315017|NCT01207934|B3|Baseline|High-dose Leptin|80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
315018|NCT01207934|B2|Baseline|Low-dose Leptin|30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
315019|NCT01207934|B1|Baseline|Placebo|saline placebo for fourteen days
315020|NCT01207934|P3|Participant Flow|High-dose Leptin|80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
315021|NCT01207934|P2|Participant Flow|Low-dose Leptin|30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
315022|NCT01207934|P1|Participant Flow|Placebo|saline placebo for fourteen days
315023|NCT01207934|O3|Outcome|High Dose Leptin|80mg leptin daily for fourteen days
315024|NCT01207934|O2|Outcome|Low Dose Leptin|30mg leptin daily for fourteen days
315025|NCT01207934|O1|Outcome|Placebo|14 days on placebo (saline)
315026|NCT01207934|O3|Outcome|High Dose Leptin|80mg leptin daily for fourteen days
315027|NCT01207934|O2|Outcome|Low Dose Leptin|30mg leptin daily for fourteen days
315028|NCT01207934|O1|Outcome|Placebo|14 days on placebo (saline)
315029|NCT01207934|O3|Outcome|High Dose Leptin|80mg leptin daily for fourteen days
315030|NCT01207934|O2|Outcome|Low Dose Leptin|30mg leptin daily for fourteen days
315031|NCT01207934|O1|Outcome|Placebo|14 days on placebo (saline)
315032|NCT01207934|O3|Outcome|High Dose Leptin|80mg leptin daily for fourteen days
315033|NCT01207934|O2|Outcome|Low Dose Leptin|30mg leptin daily for fourteen days
315034|NCT01207934|O1|Outcome|Placebo|14 days on placebo (saline)
315035|NCT01207934|E3|Reported Event|High-dose Leptin|80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
315036|NCT01207934|E2|Reported Event|Low-dose Leptin|30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
315037|NCT01207934|E1|Reported Event|Placebo|saline placebo for fourteen days
315038|NCT01207765|B1|Baseline|Zevalin|1.5mg of 111In Zevalin (containing 5 mCi of 111In) will be used for radioimaging on study day +1. 90Y Zevalin will be administered seven to nine days after 111In Zevalin administration. The dose of 90Y Zevalin will be 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
315039|NCT01207765|P1|Participant Flow|Zevalin|1.5mg of 111In Zevalin (containing 5 mCi of 111In) will be used for radioimaging on study day +1. 90Y Zevalin will be administered seven to nine days after 111In Zevalin administration. The dose of 90Y Zevalin will be 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
315040|NCT01207765|O1|Outcome|Zevalin|90Y Zevalin: Each patient will receive a single therapeutic dose of 90Y Zevalin at a dose of 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
315041|NCT01207765|O1|Outcome|Zevalin|90Y Zevalin: Each patient will receive a single therapeutic dose of 90Y Zevalin at a dose of 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
315042|NCT01207765|O1|Outcome|Zevalin|90Y Zevalin: Each patient will receive a single therapeutic dose of 90Y Zevalin at a dose of 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
315043|NCT01207765|E1|Reported Event|Zevalin|1.5mg of 111In Zevalin (containing 5 mCi of 111In) will be used for radioimaging on study day +1. 90Y Zevalin will be administered seven to nine days after 111In Zevalin administration. The dose of 90Y Zevalin will be 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
315044|NCT01207687|B1|Baseline|Treatment (Bevacizumab)|People with NF2, not eligible for surgery with progressive vestibular schwannoma
315045|NCT01207687|P1|Participant Flow|Treatment (Bevacizumab) - All Participants|Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
315046|NCT01207687|O1|Outcome|Treatment (Bevacizumab) - All Participants|Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
315047|NCT01207687|O1|Outcome|Treatment (Bevacizumab) - All Participants|Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
315048|NCT01207687|O1|Outcome|Treatment (Bevacizumab) - All Participants|Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
315049|NCT01207687|O1|Outcome|Treatment (Bevacizumab) - All Participants|Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
315050|NCT01207687|O1|Outcome|Treatment (Bevacizumab) - All Participants|Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
315051|NCT01207687|O1|Outcome|Treatment (Bevacizumab) - All Participants|Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
315052|NCT01207687|O1|Outcome|Treatment (Bevacizumab) - All Participants|Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
315053|NCT01207687|O1|Outcome|Treatment (Bevacizumab) - All Participants|Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
315054|NCT01207687|O1|Outcome|Treatment (Bevacizumab) - All Participants|Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
315055|NCT01207687|O1|Outcome|Treatment (Bevacizumab) - All Participants|Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
315056|NCT01207687|O1|Outcome|Treatment (Bevacizumab) - All Participants|Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
315057|NCT01207687|O1|Outcome|Treatment (Bevacizumab) - All Participants|Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
315058|NCT01207687|O1|Outcome|Treatment (Bevacizumab) - All Participants|Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
315059|NCT01207687|O1|Outcome|Treatment (Bevacizumab) - All Participants|Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
315060|NCT01207687|O2|Outcome|Treatment (Bevacizumab) - Pediatric Participants|All enrolled patients < 18 years of age received bevacizumab 7.5mg/kg IV once every 3 weeks for 12 months.
315061|NCT01207687|O1|Outcome|Treatment (Bevacizumab) - All Participants|All enrolled participants received bevacizumab 7.5mg/kg IV once every 3 weeks for up to 12 months.
315062|NCT01207687|O2|Outcome|Treatment (Bevacizumab) - Pediatric Participants|All enrolled patients < 18 years of age received bevacizumab 7.5mg/kg IV once every 3 weeks for 12 months.
315063|NCT01207687|O1|Outcome|Treatment (Bevacizumab) - All Participants|All enrolled participants received bevacizumab 7.5mg/kg IV once every 3 weeks for up to 12 months.
315064|NCT01207687|O2|Outcome|Treatment (Bevacizumab) - Pediatric Participants|All enrolled patients < 18 years of age received bevacizumab 7.5mg/kg IV once every 3 weeks for 12 months.
315065|NCT01207687|O1|Outcome|Treatment (Bevacizumab) - All Participants|All enrolled patients received bevacizumab 7.5mg/kg IV once every 3 weeks for 12 months.
315066|NCT01207687|O2|Outcome|Treatment (Bevacizumab) - Pediatric Participants Only|All enrolled patients < 18 years of age received bevacizumab 7.5mg/kg IV once every 3 weeks for 12 months.
315067|NCT01207687|O1|Outcome|Treatment (Bevacizumab) - All Participants|Patients who met all eligibility criteria underwent baseline evaluation and then received bevacizumab 7.5mg/kg IV once every 3 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity. Hearing evaluation for word recognition score was evaluated every 12 weeks. Hearing response was defined as improvement beyond the 95% CI maintained across 2 timepoints.
315068|NCT01207687|E2|Reported Event|Treatment (Bevacizumab) - Pediatric Participants|All enrolled patients < 18 years of age received bevacizumab 7.5mg/kg IV once every 3 weeks for 12 months.
315069|NCT01207687|E1|Reported Event|Treatment (Bevacizumab) - All Participants|All enrolled participants received bevacizumab 7.5mg/kg IV once every 3 weeks for up to 12 months.
315094|NCT01207583|P1|Participant Flow|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received 4 doses (Dose 1, Dose 2, Dose 3 and Dose 4) of 7-valent pneumococcal conjugate vaccine (PCV7) as standard care as per the Summary of Product Characteristics (SmPC).
315615|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315070|NCT01207648|B1|Baseline|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
315071|NCT01207648|P1|Participant Flow|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
315072|NCT01207648|O1|Outcome|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
315073|NCT01207648|O1|Outcome|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
315074|NCT01207648|O1|Outcome|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
315075|NCT01207648|O1|Outcome|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
315076|NCT01207648|O1|Outcome|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
315077|NCT01207648|E1|Reported Event|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
315078|NCT01207596|B1|Baseline|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
315079|NCT01207596|P1|Participant Flow|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
315080|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
315081|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
315082|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
315083|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
315084|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
315085|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
315086|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
315087|NCT01207596|E1|Reported Event|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
315088|NCT01207583|B4|Baseline|Total|Total of all reporting groups
315089|NCT01207583|B3|Baseline|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received 2 doses (Dose 1 and Dose 2) of PCV7 vaccine as standard care as per the SmPC.
315090|NCT01207583|B2|Baseline|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received 3 doses (Dose 1, Dose 2 and Dose 3) of PCV7 vaccine as standard care as per the SmPC.
315091|NCT01207583|B1|Baseline|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received 4 doses (Dose 1, Dose 2, Dose 3 and Dose 4) of PCV7 vaccine as standard care as per the SmPC.
315092|NCT01207583|P3|Participant Flow|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received 2 doses (Dose 1 and Dose 2) of PCV7 vaccine as standard care as per the SmPC.
315093|NCT01207583|P2|Participant Flow|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received 3 doses (Dose 1, Dose 2 and Dose 3) of PCV7 vaccine as standard care as per the SmPC.
315095|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 4 of PCV7 vaccine as standard care as per the SmPC.
315096|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
315097|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
315098|NCT01207583|O3|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
315099|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
315100|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
315101|NCT01207583|O3|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 1 of PCV7 vaccines as standard care as per the SmPC.
315102|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
315103|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
315104|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 4 of PCV7 vaccine as standard care as per the SmPC.
315105|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
315106|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
315107|NCT01207583|O3|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
315108|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
315109|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
315110|NCT01207583|O3|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
315111|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
315112|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
315113|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 4 of PCV7 vaccine as standard care as per the SmPC.
315114|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
315115|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
315116|NCT01207583|O3|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
315117|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
315118|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
315119|NCT01207583|O3|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
315120|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
315121|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
315122|NCT01207583|E9|Reported Event|Dose 2 (Catch-up Cohort [12-23 Months])|Participants in the age group 12-23 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
315123|NCT01207583|E8|Reported Event|Dose 1 (Catch-up Cohort [12-23 Months])|Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
315124|NCT01207583|E7|Reported Event|Dose 3 (Catch-up Cohort [7-11 Months])|Participants in the age group 7-11 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
315125|NCT01207583|E6|Reported Event|Dose 2 (Catch-up Cohort [7-11 Months])|Participants in the age group 7-11 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
315126|NCT01207583|E5|Reported Event|Dose 1 (Catch-up Cohort [7-11 Months])|Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
315127|NCT01207583|E4|Reported Event|Dose 4 (Primary Cohort [3-6 Months])|Participants in the age group 3-6 months received Dose 4 of PCV7 vaccine as standard care as per the SmPC.
315128|NCT01207583|E3|Reported Event|Dose 3 (Primary Cohort [3-6 Months])|Participants in the age group 3-6 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
315129|NCT01207583|E2|Reported Event|Dose 2 (Primary Cohort [3-6 Months])|Participants in the age group 3-6 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
315130|NCT01207583|E1|Reported Event|Dose 1 (Primary Cohort [3-6 Months])|Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
315131|NCT01207570|B3|Baseline|Total|Total of all reporting groups
315132|NCT01207570|B2|Baseline|Passive Stretching|The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes.
315133|NCT01207570|B1|Baseline|Endermotherapy|The subjects in the experimental group will receive a single session (5 minutes) of endermotherapy) applied to the gastrocnemius/soleus muscle group in the more affected side. The treatment will b e carried out by a qualified physiotherapist.
315134|NCT01207570|P2|Participant Flow|Passive Stretching|The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes.
315135|NCT01207570|P1|Participant Flow|Endermotherapy|The subjects in the experimental group will receive a single session (5 minutes) of endermotherapy) applied to the gastrocnemius/soleus muscle group in the more affected side. The treatment will b e carried out by a qualified physiotherapist.
315136|NCT01207570|O2|Outcome|Passive Stretching|A single passive stretching session
315137|NCT01207570|O1|Outcome|Endermotherapy|A single endermotherapy treatment session
315138|NCT01207570|O2|Outcome|Passive Stretching|A single passive stretching session
315139|NCT01207570|O1|Outcome|Endermotherapy|A single endermotherapy treatment session
315140|NCT01207570|O2|Outcome|Passive Stretching|A single session of passive stretching
315141|NCT01207570|O1|Outcome|Endermotherapy|A single session of endermotherapy treatment
315142|NCT01207570|O2|Outcome|Passive Stretching|A single passive stretching session
315143|NCT01207570|O1|Outcome|Endermotherapy|A single endermotherapy treatment session
315144|NCT01207570|E2|Reported Event|Passive Stretching|The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes.
315145|NCT01207570|E1|Reported Event|Endermotherapy|The subjects in the experimental group will receive a single session (5 minutes) of endermotherapy) applied to the gastrocnemius/soleus muscle group in the more affected side. The treatment will b e carried out by a qualified physiotherapist.
315146|NCT01207492|B1|Baseline|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously~nilotinib: Taken orally twice daily"
315147|NCT01207492|P1|Participant Flow|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously~nilotinib: Taken orally twice daily"
315148|NCT01207492|O1|Outcome|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously~nilotinib: Taken orally twice daily"
315149|NCT01207492|O1|Outcome|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously~nilotinib: Taken orally twice daily"
315150|NCT01207492|O1|Outcome|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously~nilotinib: Taken orally twice daily"
315151|NCT01207492|E1|Reported Event|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously~nilotinib: Taken orally twice daily"
315152|NCT01207466|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects.
315153|NCT01207466|P2|Participant Flow|Nelfilcon A Comm'l / nelfilconA Invest'l|Nelfilcon A commercial toric contact lenses worn first, with nelfilcon A investigational toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.
315154|NCT01207466|P1|Participant Flow|Nelfilcon A Invest'l / nelfilconA Comm'l|Nelfilcon A investigational toric contact lenses worn first, with nelfilcon A commercial toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.
315155|NCT01207466|O2|Outcome|Nelfilcon A Commercial|Commercially marketed, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.
315156|NCT01207466|O1|Outcome|Nelfilcon A Investigational|Investigational, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.
315157|NCT01207466|E2|Reported Event|Nelfilcon A Commercial|Commercially marketed, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.
315158|NCT01207466|E1|Reported Event|Nelfilcon A Investigational|Investigational, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.
315159|NCT01207453|B3|Baseline|Total|Total of all reporting groups
315160|NCT01207453|B2|Baseline|Placebo and Then Milnacipran|Participants first received 6 weeks of placebo. This was followed by a 3-week wash-out. After the wash-out period, participants then received 6 weeks of milnacipran (titrated up to full dose of 50 mg twice daily).
315161|NCT01207453|B1|Baseline|Milnacipran and Then Placebo|Participants first received 6 weeks of milnacipran (titrated up to full dose of 50 mg twice daily). This was followed by a 3-week wash-out. Participants then received 6 weeks of placebo.
315162|NCT01207453|P2|Participant Flow|Placebo and Then Milnacipran|Participants first received 6 weeks of placebo. This was followed by a 3-week wash-out. After the wash-out period, participants then received 6 weeks of milnacipran (titrated up to full dose of 50 mg twice daily).
315163|NCT01207453|P1|Participant Flow|Milnacipran and Then Placebo|Participants first received 6 weeks of milnacipran (titrated up to full dose of 50 mg twice daily). This was followed by a 3-week wash-out. Participants then received 6 weeks of placebo.
315164|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.~Milnacipran: Milnacipran comes in 50 mg tablets and is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily."
315165|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
315166|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.~Milnacipran: Milnacipran comes in 50 mg tablets and is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily."
315167|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
315168|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.~Milnacipran: Milnacipran comes in 50 mg tablets and is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily."
315169|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
315170|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.~Milnacipran: Milnacipran comes in 50 mg tablets and is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily."
315171|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
315172|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.~Milnacipran: Milnacipran comes in 50 mg tablets and is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily."
315173|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
315256|NCT01207219|O2|Outcome|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
315174|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.~Milnacipran: Participants who take Milnacipran twice a day orally dosage was titrated up to target dosage of 50 mg (12.5 mg, 25 mg and 50 mg)."
315175|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
315176|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.~Milnacipran is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily."
315177|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
315178|NCT01207453|E3|Reported Event|Washout Period|This 3-week period occurred after the first 6 weeks (when participants either received milnacipran or placebo). During the washout period, participants down titrated from the full dosage of milnacipran/placebo to nothing.
315179|NCT01207453|E2|Reported Event|Placebo|Participants received placebo tablets for 6 weeks. The tablets were identical in appearance to the milnacipran tablets.
315180|NCT01207453|E1|Reported Event|Milnacipran|Participants received milnacipran for 6 weeks. The dose was titrated according to the following schedule: 1) Days 1-3: milnacipran 12.5 mg twice daily, 2) Days 4-6: milnacipran 25 mg twice daily, 3) Days 7-42: milnacipran 50 mg twice daily. If participants could not tolerate the full dose, the dose was decreased to the highest tolerated dose.
315181|NCT01207427|B4|Baseline|Total|Total of all reporting groups
315182|NCT01207427|B3|Baseline|Placebo|Each participant received 1 placebo capsule orally twice daily (BID) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
315183|NCT01207427|B2|Baseline|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
315184|NCT01207427|B1|Baseline|ADL5945 0.1 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.1 mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
315185|NCT01207427|P3|Participant Flow|Placebo|Each participant received 1 placebo capsule orally twice daily (BID) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
315186|NCT01207427|P2|Participant Flow|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
315187|NCT01207427|P1|Participant Flow|ADL5945 0.1 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.1-milligrams (mg) ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
315188|NCT01207427|O3|Outcome|Placebo|Each participant received 1 placebo capsule orally twice daily (BID) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
315189|NCT01207427|O2|Outcome|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
315190|NCT01207427|O1|Outcome|ADL5945 0.1 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.1-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
315191|NCT01207427|E3|Reported Event|Placebo|Each participant received 1 placebo capsule orally twice daily (BID) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
315192|NCT01207427|E2|Reported Event|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
315193|NCT01207427|E1|Reported Event|ADL5945 0.1 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.1- mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
315194|NCT01207414|B3|Baseline|Total|Total of all reporting groups
315195|NCT01207414|B2|Baseline|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
315196|NCT01207414|B1|Baseline|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
315197|NCT01207414|P2|Participant Flow|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
317378|NCT01200524|E2|Reported Event|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
315198|NCT01207414|P1|Participant Flow|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
315199|NCT01207414|O2|Outcome|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
315200|NCT01207414|O1|Outcome|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
315201|NCT01207414|O2|Outcome|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
315202|NCT01207414|O1|Outcome|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
315203|NCT01207414|O2|Outcome|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
315204|NCT01207414|O1|Outcome|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
315205|NCT01207414|O2|Outcome|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
315206|NCT01207414|O1|Outcome|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
315207|NCT01207414|O2|Outcome|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
315208|NCT01207414|O1|Outcome|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
315209|NCT01207414|O2|Outcome|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
315210|NCT01207414|O1|Outcome|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
315211|NCT01207414|E2|Reported Event|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
315257|NCT01207219|O1|Outcome|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
315258|NCT01207219|O3|Outcome|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
315212|NCT01207414|E1|Reported Event|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
315213|NCT01207401|B3|Baseline|Total|Total of all reporting groups
315214|NCT01207401|B2|Baseline|No Paracervical Block|
315215|NCT01207401|B1|Baseline|Paracervical Block|
315216|NCT01207401|P2|Participant Flow|No Paracervical Block|IUD insertion with no lidocaine injection
315217|NCT01207401|P1|Participant Flow|Paracervical Block|IUD insertion after a 10 cc 1% Lidocaine administeration at 4 o'clock and 8 o'clock at the cervical-vaginal mucosa.
315218|NCT01207401|O2|Outcome|No Paracervical Block|
315219|NCT01207401|O1|Outcome|Paracervical Block|
315220|NCT01207401|E2|Reported Event|No Paracervical Block|
315221|NCT01207401|E1|Reported Event|Paracervical Block|
315222|NCT01207388|B1|Baseline|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
315223|NCT01207388|P1|Participant Flow|Blinatumomab|"Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.~Participants suitable for allogeneic hematopoietic stem cell transplant (HSCT) after treatment with at least 1 cycle of blinatumomab may have undergone allogeneic HSCT instead of receiving further cycles with blinatumomab."
315224|NCT01207388|O2|Outcome|Change From Baseline at End of Core Study|
315225|NCT01207388|O1|Outcome|Maximum Change From Baseline in Cycles 1 - 4|
315226|NCT01207388|O2|Outcome|Change From Baseline at End of Core Study|
315227|NCT01207388|O1|Outcome|Maximum Change From Baseline in Cycles 1 - 4|
315228|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
315229|NCT01207388|O6|Outcome|Cycle 1 MRD Unknown|Participants with an unknown MRD level at the end of cycle 1.
315230|NCT01207388|O5|Outcome|Cycle 1 MRD 10^-1|Participants with an MRD level 10^-1 at the end of cycle 1.
315231|NCT01207388|O4|Outcome|Cycle 1 MRD 10^-2|Participants with an MRD level 10^-2 at the end of cycle 1.
315232|NCT01207388|O3|Outcome|Cycle 1 MRD 10^-3|Participants with an MRD level 10^-3 at the end of cycle 1.
315233|NCT01207388|O2|Outcome|Cycle 1 MRD 10^-4|Participants with an MRD level 10^-4 at the end of cycle 1.
315234|NCT01207388|O1|Outcome|Cycle 1 MRD 10^-5|Participants with an MRD level 10^-5 at the end of cycle 1.
315235|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
315236|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
315237|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
315238|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
315239|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
315240|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
315241|NCT01207388|E1|Reported Event|Blinatumomab 15 µg/m2/d|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
315242|NCT01207219|B4|Baseline|Total|Total of all reporting groups
315243|NCT01207219|B3|Baseline|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
315244|NCT01207219|B2|Baseline|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
315245|NCT01207219|B1|Baseline|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
315246|NCT01207219|P3|Participant Flow|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
315247|NCT01207219|P2|Participant Flow|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
315248|NCT01207219|P1|Participant Flow|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
315249|NCT01207219|O3|Outcome|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
315250|NCT01207219|O2|Outcome|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
315251|NCT01207219|O1|Outcome|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
315252|NCT01207219|O3|Outcome|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
315253|NCT01207219|O2|Outcome|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
315254|NCT01207219|O1|Outcome|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
315255|NCT01207219|O3|Outcome|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
315259|NCT01207219|O2|Outcome|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
315260|NCT01207219|O1|Outcome|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
315261|NCT01207219|O3|Outcome|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
315262|NCT01207219|O2|Outcome|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
315263|NCT01207219|O1|Outcome|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
315264|NCT01207219|E3|Reported Event|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
315265|NCT01207219|E2|Reported Event|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
315266|NCT01207219|E1|Reported Event|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
315267|NCT01207102|B1|Baseline|Abraxane, Carboplatin|"Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle~Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days~Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days"
315268|NCT01207102|P1|Participant Flow|Abraxane, Carboplatin|"Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle~Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days~Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days"
315269|NCT01207102|O1|Outcome|Abraxane, Carboplatin|"Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle~Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days~Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days"
315270|NCT01207102|O1|Outcome|Abraxane, Carboplatin|"Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle~Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days~Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days"
315271|NCT01207102|E1|Reported Event|Abraxane, Carboplatin|"Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle~Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days~Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days"
315272|NCT01206777|B1|Baseline|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
315273|NCT01206777|P1|Participant Flow|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
315274|NCT01206777|O1|Outcome|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
315275|NCT01206777|O1|Outcome|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
315276|NCT01206777|O1|Outcome|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
315277|NCT01206777|E1|Reported Event|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
315278|NCT01206738|B4|Baseline|Total|Total of all reporting groups
315279|NCT01206738|B3|Baseline|General Information|No information beyond the information that GPs already have from guidelines and other diverse sources (ie. usual care)
315280|NCT01206738|B2|Baseline|Alternative Intervention|Action Plan. The work linking simulated prescribing behaviour to predictors of that behaviour suggested that an action plan, detailing situations where GPs found it difficult to not prescribe an antibiotic and offering ways in which the GP could avoid prescribing an antibiotic when this was not necessary.
315281|NCT01206738|B1|Baseline|Persuasive Communication|The persuasive intervention aimed to reinforce the GP’s beliefs about the positive consequences of managing sore throat without prescribing antibiotics.
315282|NCT01206738|P3|Participant Flow|General Information|"No information beyond the information that GPs already have from guidelines and other diverse sources (ie. usual care).~Note: for the Overall study, the best 25% of prescribers completing the email vs postal invitation sub study (which 270 individuals completed) were not eligible by definition (we only wanted to trial our interventions with doctors not prescribing according to best practice). Of the 270, only 201 were eligible. All were invited to participate, along with 313 other family doctors who had not taken part in the email vs. postal invitation study. Of the 514 (201 + 313) invited to the Overall study, 198 responded and these are the participants for the Overall study."
315283|NCT01206738|P2|Participant Flow|Alternative Intervention|"Action Plan. The work linking simulated prescribing behaviour to predictors of that behaviour suggested that an action plan, detailing situations where GPs found it difficult to not prescribe an antibiotic and offering ways in which the GP could avoid prescribing an antibiotic when this was not necessary.~Note: for the Overall study, the best 25% of prescribers completing the email vs postal invitation sub study (which 270 individuals completed) were not eligible by definition (we only wanted to trial our interventions with doctors not prescribing according to best practice). Of the 270, only 201 were eligible. All were invited to participate, along with 313 other family doctors who had not taken part in the email vs. postal invitation study. Of the 514 (201 + 313) invited to the Overall study, 198 responded and these are the participants for the Overall study."
315313|NCT01206608|E2|Reported Event|Mid-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
315314|NCT01206608|E1|Reported Event|Low-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
315315|NCT01206595|B3|Baseline|Total|Total of all reporting groups
317379|NCT01200524|E1|Reported Event|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
315284|NCT01206738|P1|Participant Flow|Persuasive Communication|"The persuasive intervention aimed to reinforce the GP’s beliefs about the positive consequences of managing sore throat without prescribing antibiotics.~Note: for the Overall study, the best 25% of prescribers completing the email vs postal invitation sub study (which 270 individuals completed) were not eligible by definition (we only wanted to trial our interventions with doctors not prescribing according to best practice). Of the 270, only 201 were eligible. All were invited to participate, along with 313 other family doctors who had not taken part in the email vs. postal invitation study. Of the 514 (201 + 313) invited to the Overall study, 198 responded and these are the participants for the Overall study."
315285|NCT01206738|O2|Outcome|Post|GPs receiving a postal invitation
315286|NCT01206738|O1|Outcome|Email|GPs receiving an email invitation
315287|NCT01206738|O3|Outcome|General Information|"No additional information was provided; the general information was the information already available to GPs about antibiotic prescribing.~General intervention: No additional information was provided; the general information was the information already available to GPs about antibiotic prescribing."
315288|NCT01206738|O2|Outcome|Alternative Intervention|"This intervention was an action plan, supporting the GP to deal with two difficult prescribing situations: 1) a distressed patient (or often distressed parent of a child patient) 2) a patient demanding an antibiotic~Action plan: This intervention was an action plan, supporting the GP to deal with two difficult prescribing situations: 1) a distressed patient (or often distressed parent of a child patient) 2) a patient demanding an antibiotic"
315289|NCT01206738|O1|Outcome|Persuasive Communication|"The persuasive intervention aimed to reinforce the GP’s beliefs about the positive consequences of managing sore throat without prescribing antibiotics.~Persuasive communication: The persuasive intervention aimed to reinforce the GP’s beliefs about the positive consequences of managing sore throat without prescribing antibiotics."
315290|NCT01206738|E3|Reported Event|General Information|No information beyond the information that GPs already have from guidelines and other diverse sources (ie. usual care)
315291|NCT01206738|E2|Reported Event|Alternative Intervention|Action Plan. The work linking simulated prescribing behaviour to predictors of that behaviour suggested that an action plan, detailing situations where GPs found it difficult to not prescribe an antibiotic and offering ways in which the GP could avoid prescribing an antibiotic when this was not necessary.
315292|NCT01206738|E1|Reported Event|Persuasive Communication|The persuasive intervention aimed to reinforce the GP’s beliefs about the positive consequences of managing sore throat without prescribing antibiotics.
315293|NCT01206660|B3|Baseline|Total|Total of all reporting groups
315294|NCT01206660|B2|Baseline|Placebo|"Placebo administered to affected area twice a day for 28 days~placebo: Placebo administered to affected area twice a day for 28 days"
315295|NCT01206660|B1|Baseline|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days~Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
315296|NCT01206660|P2|Participant Flow|Placebo|"Placebo administered to affected area twice a day for 28 days~placebo: Placebo administered to affected area twice a day for 28 days"
315297|NCT01206660|P1|Participant Flow|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days~Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
315298|NCT01206660|O2|Outcome|Placebo|"Placebo administered to affected area twice a day for 28 days~placebo: Placebo administered to affected area twice a day for 28 days"
315299|NCT01206660|O1|Outcome|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days~Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
315300|NCT01206660|O2|Outcome|Placebo|"Placebo administered to affected area twice a day for 28 days~placebo: Placebo administered to affected area twice a day for 28 days"
315301|NCT01206660|O1|Outcome|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days~Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
315302|NCT01206660|O2|Outcome|Placebo|"Placebo administered to affected area twice a day for 28 days~placebo: Placebo administered to affected area twice a day for 28 days"
315303|NCT01206660|O1|Outcome|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days~Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
315304|NCT01206660|E2|Reported Event|Placebo|"Placebo administered to affected area twice a day for 28 days~placebo: Placebo administered to affected area twice a day for 28 days"
315305|NCT01206660|E1|Reported Event|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days~Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
315306|NCT01206608|B3|Baseline|Total|Total of all reporting groups
315307|NCT01206608|B2|Baseline|Mid-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
315308|NCT01206608|B1|Baseline|Low-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
315309|NCT01206608|P2|Participant Flow|Mid-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
315310|NCT01206608|P1|Participant Flow|Low-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
315311|NCT01206608|O2|Outcome|Mid-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402. A single dose of study drug was administration via local infiltration.
315312|NCT01206608|O1|Outcome|Low-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402. A single dose of study drug was administration via local infiltration.
318031|NCT01198574|O1|Outcome|Iron Group|60 mg Elemental iron with 2.5 mg folic acid + Vitamin A placebo
315316|NCT01206595|B2|Baseline|Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
315317|NCT01206595|B1|Baseline|SKY0402|Low-dose, low-mid dose, and mid-dose
315318|NCT01206595|P2|Participant Flow|Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
315319|NCT01206595|P1|Participant Flow|SKY0402|Low-dose, low-mid dose, and mid-dose
315320|NCT01206595|O4|Outcome|SKY0402 Mid Dose|A single dose of SKY0402 (mid dose) was administered intraoperatively by local infiltration.
315321|NCT01206595|O3|Outcome|SKY0402 Low-Mid Dose|A single dose of SKY0402 (low-mid dose) was administered intraoperatively by local infiltration.
315322|NCT01206595|O2|Outcome|SKY0402 Low Dose|A single dose of SKY0402 (low dose) was administered intraoperatively by local infiltration.
315323|NCT01206595|O1|Outcome|Bupivacaine HCl|A single dose of bupivacaine HCl 125 mg was administered intraoperatively by local infiltration.
315324|NCT01206595|E2|Reported Event|Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
315325|NCT01206595|E1|Reported Event|SKY0402|Low-dose, low-mid dose, and mid-dose
315326|NCT01206582|B3|Baseline|Total|Total of all reporting groups
315327|NCT01206582|B2|Baseline|Albumin|10 iv infusions for 8 weeks
315328|NCT01206582|B1|Baseline|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
315329|NCT01206582|P2|Participant Flow|Albumin|10 iv infusions for 8 weeks
315330|NCT01206582|P1|Participant Flow|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, Illinois (IL). Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
315331|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
315332|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
315333|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
315334|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
315335|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
315336|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
315337|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
315338|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
315339|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
315340|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
315341|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
315342|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
315343|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
315344|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
315345|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
315346|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
315347|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
315348|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
315349|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
315350|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
315351|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
315352|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
315353|NCT01206582|E2|Reported Event|Albumin|10 iv infusions for 8 weeks
315354|NCT01206582|E1|Reported Event|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
315355|NCT01206517|B7|Baseline|Total|Total of all reporting groups
315356|NCT01206517|B6|Baseline|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
315357|NCT01206517|B5|Baseline|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
315659|NCT01205776|E2|Reported Event|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315358|NCT01206517|B4|Baseline|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
315359|NCT01206517|B3|Baseline|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
315360|NCT01206517|B2|Baseline|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
315361|NCT01206517|B1|Baseline|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
315362|NCT01206517|P6|Participant Flow|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
315363|NCT01206517|P5|Participant Flow|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
315364|NCT01206517|P4|Participant Flow|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
315365|NCT01206517|P3|Participant Flow|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
315366|NCT01206517|P2|Participant Flow|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
315367|NCT01206517|P1|Participant Flow|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
315368|NCT01206517|O6|Outcome|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
315369|NCT01206517|O5|Outcome|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
315370|NCT01206517|O4|Outcome|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
315371|NCT01206517|O3|Outcome|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
315372|NCT01206517|O2|Outcome|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
315373|NCT01206517|O1|Outcome|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
315374|NCT01206517|O6|Outcome|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
315375|NCT01206517|O5|Outcome|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
315376|NCT01206517|O4|Outcome|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
315377|NCT01206517|O3|Outcome|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
315378|NCT01206517|O2|Outcome|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
315379|NCT01206517|O1|Outcome|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
315380|NCT01206517|O6|Outcome|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
315381|NCT01206517|O5|Outcome|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
315382|NCT01206517|O4|Outcome|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
315431|NCT01206387|P1|Participant Flow|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
315432|NCT01206387|O2|Outcome|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
315383|NCT01206517|O3|Outcome|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
315384|NCT01206517|O2|Outcome|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
315385|NCT01206517|O1|Outcome|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
315386|NCT01206517|O6|Outcome|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
315387|NCT01206517|O5|Outcome|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
315388|NCT01206517|O4|Outcome|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
315389|NCT01206517|O3|Outcome|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
315390|NCT01206517|O2|Outcome|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
315391|NCT01206517|O1|Outcome|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
315392|NCT01206517|E3|Reported Event|Asenapine 10 mg - Cohort 3a-d|"Participants 10-17 years of age:~Participants 10 or 11 years of age (Cohort 3a); administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12~Participants 12-17 years of age (Cohort 3b-d); administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8"
315393|NCT01206517|E2|Reported Event|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
315394|NCT01206517|E1|Reported Event|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
315395|NCT01206478|B3|Baseline|Total|Total of all reporting groups
315396|NCT01206478|B2|Baseline|Placebo, Megestrol|"Placebo: Placebo (looks like study drug but has no active ingredients) once daily at bedtime.~At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day."
315397|NCT01206478|B1|Baseline|Amitriptyline, Megestrol|Amitriptyline 1 mg/kg: Amitriptyline 1 mg/kg once daily at bedtime. At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
315398|NCT01206478|P2|Participant Flow|Placebo, Megestrol|"Placebo: Placebo (looks like study drug but has no active ingredients) once daily at bedtime.~At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day."
315399|NCT01206478|P1|Participant Flow|Amitriptyline, Megestrol|Amitriptyline 1 mg/kg: Amitriptyline 1 mg/kg once daily at bedtime. At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
315400|NCT01206478|O2|Outcome|Placebo, Megestrol|"Placebo: Placebo (looks like study drug but has no active ingredients) once daily at bedtime.~At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day."
315401|NCT01206478|O1|Outcome|Amitriptyline, Megestrol|Amitriptyline 1 mg/kg: Amitriptyline 1 mg/kg once daily at bedtime. At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
315402|NCT01206478|O2|Outcome|Placebo, Megestrol|"Placebo: Placebo (looks like study drug but has no active ingredients) once daily at bedtime.~At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day."
315403|NCT01206478|O1|Outcome|Amitriptyline, Megestrol|Amitriptyline 1 mg/kg: Amitriptyline 1 mg/kg once daily at bedtime. At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
315433|NCT01206387|O1|Outcome|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
315434|NCT01206387|O2|Outcome|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
315404|NCT01206478|E2|Reported Event|Placebo, Megestrol|"Placebo: Placebo (looks like study drug but has no active ingredients) once daily at bedtime.~At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day."
315405|NCT01206478|E1|Reported Event|Amitriptyline, Megestrol|Amitriptyline 1 mg/kg: Amitriptyline 1 mg/kg once daily at bedtime. At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
315406|NCT01206452|B3|Baseline|Total|Total of all reporting groups
315407|NCT01206452|B2|Baseline|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.~Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
315408|NCT01206452|B1|Baseline|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.~Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
315409|NCT01206452|P2|Participant Flow|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.~Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
315410|NCT01206452|P1|Participant Flow|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.~Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
315411|NCT01206452|O2|Outcome|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.~Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
315412|NCT01206452|O1|Outcome|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.~Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
315413|NCT01206452|O2|Outcome|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.~Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
315414|NCT01206452|O1|Outcome|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.~Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
315415|NCT01206452|O2|Outcome|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.~Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
315416|NCT01206452|O1|Outcome|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.~Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
315417|NCT01206452|O2|Outcome|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.~Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
315418|NCT01206452|O1|Outcome|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.~Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
315419|NCT01206452|O2|Outcome|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.~Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
315420|NCT01206452|O1|Outcome|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.~Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
315421|NCT01206452|E2|Reported Event|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.~Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
315422|NCT01206452|E1|Reported Event|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.~Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
315423|NCT01206439|B1|Baseline|Nebivolol 5 or 10 mg, Oral, Daily|"Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.~nebivolol: nebivolol 5 or 10 mg oral, daily"
315424|NCT01206439|P1|Participant Flow|Nebivolol 5 or 10 mg, Oral, Daily|"Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.~nebivolol: nebivolol 5 or 10 mg oral, daily"
315425|NCT01206439|O1|Outcome|Nebivolol 5 or 10 mg, Oral, Daily|"Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.~nebivolol: nebivolol 5 or 10 mg oral, daily"
315426|NCT01206439|E1|Reported Event|Nebivolol 5 or 10 mg, Oral, Daily|"Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.~nebivolol: nebivolol 5 or 10 mg oral, daily"
315427|NCT01206387|B3|Baseline|Total|Total of all reporting groups
315428|NCT01206387|B2|Baseline|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
315429|NCT01206387|B1|Baseline|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
315430|NCT01206387|P2|Participant Flow|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
315435|NCT01206387|O1|Outcome|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
315436|NCT01206387|O2|Outcome|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
315437|NCT01206387|O1|Outcome|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
315438|NCT01206387|O2|Outcome|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
315439|NCT01206387|O1|Outcome|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
315440|NCT01206387|O2|Outcome|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
315441|NCT01206387|O1|Outcome|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
315442|NCT01206387|E2|Reported Event|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
315443|NCT01206387|E1|Reported Event|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
315444|NCT01206322|B3|Baseline|Total|Total of all reporting groups
315445|NCT01206322|B2|Baseline|Diabetics|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo ( sterilesaline) in type 2 diabetes and the non-diabetic control group.Each participant received a single dose of insulin and a single dose of placebo on 2 consequent days in random order."
315446|NCT01206322|B1|Baseline|Healthy|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo ( sterilesaline) in type 2 diabetes and the non-diabetic control group.Each participant received a single dose of insulin and a single dose of placebo on 2 consequent days in random order."
315447|NCT01206322|P4|Participant Flow|Control Group: Insulin First|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo"
315448|NCT01206322|P3|Participant Flow|Control Group: Placebo First|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo"
315449|NCT01206322|P2|Participant Flow|Diabetes Group: Insulin First|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo"
315450|NCT01206322|P1|Participant Flow|Diabetes Group: Placebo First|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo"
315451|NCT01206322|O4|Outcome|Control Group: Insulin|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R)).
315452|NCT01206322|O3|Outcome|Control Group: Placebo|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R)).
315453|NCT01206322|O2|Outcome|Diabetes Group: Insulin|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group.
315454|NCT01206322|O1|Outcome|Diabetes Group: Placebo|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R))."
315455|NCT01206322|O4|Outcome|Control Group: Insulin|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R)).
315456|NCT01206322|O3|Outcome|Control Group: Placebo|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R)).
315457|NCT01206322|O2|Outcome|Diabetes Group: Insulin|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group.
315458|NCT01206322|O1|Outcome|Diabetes Group: Placebo|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R))."
315459|NCT01206322|E4|Reported Event|Control Group: Insulin|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the non-diabetic control group.~The intranasal administration of insulin was safe, with no serious adverse events or hypoglycemic episodes and the protocol was feasible for participants."
315460|NCT01206322|E3|Reported Event|Control Group: Placebo|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the non-diabetic control group.~The intranasal administration of insulin was safe, with no serious adverse events or hypoglycemic episodes and the protocol was feasible for participants."
315461|NCT01206322|E2|Reported Event|Diabetes Group: Insulin|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the non-diabetic control group.~The intranasal administration of insulin was safe, with no serious adverse events or hypoglycemic episodes and the protocol was feasible for participants."
315488|NCT01206101|O1|Outcome|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
315462|NCT01206322|E1|Reported Event|Diabetes Group: Placebo|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the non-diabetic control group.~The intranasal administration of insulin was safe, with no serious adverse events or hypoglycemic episodes and the protocol was feasible for participants."
315463|NCT01206140|B3|Baseline|Total|Total of all reporting groups
315464|NCT01206140|B2|Baseline|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO~Temsirolimus: Given IV"
315465|NCT01206140|B1|Baseline|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
315466|NCT01206140|P2|Participant Flow|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO~Temsirolimus: Given IV"
315467|NCT01206140|P1|Participant Flow|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
315468|NCT01206140|O2|Outcome|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO~Temsirolimus: Given IV"
315469|NCT01206140|O1|Outcome|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
315470|NCT01206140|O2|Outcome|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO~Temsirolimus: Given IV"
315471|NCT01206140|O1|Outcome|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
315472|NCT01206140|O2|Outcome|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO~Temsirolimus: Given IV"
315473|NCT01206140|O1|Outcome|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
315474|NCT01206140|E2|Reported Event|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO~Temsirolimus: Given IV"
315475|NCT01206140|E1|Reported Event|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
315476|NCT01206101|B3|Baseline|Total|Total of all reporting groups
315477|NCT01206101|B2|Baseline|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
315478|NCT01206101|B1|Baseline|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
315479|NCT01206101|P2|Participant Flow|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
315480|NCT01206101|P1|Participant Flow|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
315481|NCT01206101|O2|Outcome|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
315482|NCT01206101|O1|Outcome|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
315483|NCT01206101|O2|Outcome|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
315484|NCT01206101|O1|Outcome|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
315485|NCT01206101|O2|Outcome|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
315486|NCT01206101|O1|Outcome|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
315487|NCT01206101|O2|Outcome|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
315571|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315489|NCT01206101|O2|Outcome|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
315490|NCT01206101|O1|Outcome|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
315491|NCT01206101|O2|Outcome|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
315492|NCT01206101|O1|Outcome|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
315493|NCT01206101|E2|Reported Event|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
315494|NCT01206101|E1|Reported Event|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
315495|NCT01206062|B3|Baseline|Total|Total of all reporting groups
315496|NCT01206062|B2|Baseline|Standard Control of SBP|"Participants randomized into the Standard arm had a goal of SBP <140 mm Hg. Intensify therapy if SBP ≥160 mm Hg @ 1 visit; ≥140 mm Hg @ 2 consecutive visits; Down-titration if SBP <130 mm Hg @ 1 visit; <135 mm Hg @ 2 consecutive visits~Standard control of SBP: The same medications used in the Intensive BP arm will be used for the Standard BP arm."
315497|NCT01206062|B1|Baseline|Intensive Control of SBP|"Participants randomized into the Intensive BP arm had a goal of SBP <120 mm Hg. 2-drug therapy initiated in most participants; age ≥75 years and SBP 130-139 mm Hg on 0-1 drug; may begin with 1 drug, but add second at 1 month if SBP ≥130 mm Hg; drugs added and/or titrated at each visit (monthly) to achieve SBP <120 mm Hg; at periodic visits: addition of another drug required if not at goal.~Intensive control of SBP: Use of once-daily antihypertensive agents was encouraged unless alternative frequency was necessary. One or more medications from the following classes of agents were provided by the study for use in managing participants in both groups to achieve study goals:~Angiotension converting enzyme (ACE)-inhibitors Angiotension receptor blockers (ARBs) Direct vasodilators Thiazide-type diuretics Loop diuretics Potassium-sparing diuretics Beta-blockers Sustained-release calcium channel blockers (CCBs) Alpha1-receptor blockers Sympatholytics"
315498|NCT01206062|P2|Participant Flow|Standard Control of SBP|"Participants randomized into the Standard arm had a goal of SBP <140 mm Hg. Intensify therapy if SBP ≥160 mm Hg @ 1 visit; ≥140 mm Hg @ 2 consecutive visits; Down-titration if SBP <130 mm Hg @ 1 visit; <135 mm Hg @ 2 consecutive visits~Standard control of SBP: The same medications used in the Intensive BP arm will be used for the Standard BP arm."
315499|NCT01206062|P1|Participant Flow|Intensive Control of SBP|"Participants randomized into the Intensive BP arm had a goal of SBP <120 mm Hg. 2-drug therapy initiated in most participants; age ≥75 years and SBP 130-139 mm Hg on 0-1 drug; may begin with 1 drug, but add second at 1 month if SBP ≥130 mm Hg; drugs added and/or titrated at each visit (monthly) to achieve SBP <120 mm Hg; at periodic visits: addition of another drug required if not at goal.~Intensive control of SBP: Use of once-daily antihypertensive agents was encouraged unless alternative frequency was necessary. One or more medications from the following classes of agents were provided by the study for use in managing participants in both groups to achieve study goals:~Angiotension converting enzyme (ACE)-inhibitors Angiotension receptor blockers (ARBs) Direct vasodilators Thiazide-type diuretics Loop diuretics Potassium-sparing diuretics Beta-blockers Sustained-release calcium channel blockers (CCBs) Alpha1-receptor blockers Sympatholytics"
315500|NCT01206062|O2|Outcome|Standard Control of SBP|"Participants randomized into the Standard arm had a goal of SBP <140 mm Hg. Intensify therapy if SBP ≥160 mm Hg @ 1 visit; ≥140 mm Hg @ 2 consecutive visits; Down-titration if SBP <130 mm Hg @ 1 visit; <135 mm Hg @ 2 consecutive visits~Standard control of SBP: The same medications used in the Intensive BP arm will be used for the Standard BP arm."
315501|NCT01206062|O1|Outcome|Intensive Control of SBP|"Participants randomized into the Intensive BP arm had a goal of SBP <120 mm Hg. 2-drug therapy initiated in most participants; age ≥75 years and SBP 130-139 mm Hg on 0-1 drug; may begin with 1 drug, but add second at 1 month if SBP ≥130 mm Hg; drugs added and/or titrated at each visit (monthly) to achieve SBP <120 mm Hg; at periodic visits: addition of another drug required if not at goal.~Intensive control of SBP: Use of once-daily antihypertensive agents was encouraged unless alternative frequency was necessary. One or more medications from the following classes of agents were provided by the study for use in managing participants in both groups to achieve study goals:~Angiotension converting enzyme (ACE)-inhibitors Angiotension receptor blockers (ARBs) Direct vasodilators Thiazide-type diuretics Loop diuretics Potassium-sparing diuretics Beta-blockers Sustained-release calcium channel blockers (CCBs) Alpha1-receptor blockers Sympatholytics"
315502|NCT01206062|O2|Outcome|Standard Control of SBP|"Participants randomized into the Standard arm had a goal of SBP <140 mm Hg. Intensify therapy if SBP ≥160 mm Hg @ 1 visit; ≥140 mm Hg @ 2 consecutive visits; Down-titration if SBP <130 mm Hg @ 1 visit; <135 mm Hg @ 2 consecutive visits~Standard control of SBP: The same medications used in the Intensive BP arm will be used for the Standard BP arm."
315503|NCT01206062|O1|Outcome|Intensive Control of SBP|"Participants randomized into the Intensive BP arm had a goal of SBP <120 mm Hg. 2-drug therapy initiated in most participants; age ≥75 years and SBP 130-139 mm Hg on 0-1 drug; may begin with 1 drug, but add second at 1 month if SBP ≥130 mm Hg; drugs added and/or titrated at each visit (monthly) to achieve SBP <120 mm Hg; at periodic visits: addition of another drug required if not at goal.~Intensive control of SBP: Use of once-daily antihypertensive agents was encouraged unless alternative frequency was necessary. One or more medications from the following classes of agents were provided by the study for use in managing participants in both groups to achieve study goals:~Angiotension converting enzyme (ACE)-inhibitors Angiotension receptor blockers (ARBs) Direct vasodilators Thiazide-type diuretics Loop diuretics Potassium-sparing diuretics Beta-blockers Sustained-release calcium channel blockers (CCBs) Alpha1-receptor blockers Sympatholytics"
315504|NCT01206062|O2|Outcome|Standard Control of SBP|"Participants randomized into the Standard arm had a goal of SBP <140 mm Hg. Intensify therapy if SBP ≥160 mm Hg @ 1 visit; ≥140 mm Hg @ 2 consecutive visits; Down-titration if SBP <130 mm Hg @ 1 visit; <135 mm Hg @ 2 consecutive visits~Standard control of SBP: The same medications used in the Intensive BP arm will be used for the Standard BP arm."
315505|NCT01206062|O1|Outcome|Intensive Control of SBP|"Participants randomized into the Intensive BP arm had a goal of SBP <120 mm Hg. 2-drug therapy initiated in most participants; age ≥75 years and SBP 130-139 mm Hg on 0-1 drug; may begin with 1 drug, but add second at 1 month if SBP ≥130 mm Hg; drugs added and/or titrated at each visit (monthly) to achieve SBP <120 mm Hg; at periodic visits: addition of another drug required if not at goal.~Intensive control of SBP: Use of once-daily antihypertensive agents was encouraged unless alternative frequency was necessary. One or more medications from the following classes of agents were provided by the study for use in managing participants in both groups to achieve study goals:~Angiotension converting enzyme (ACE)-inhibitors Angiotension receptor blockers (ARBs) Direct vasodilators Thiazide-type diuretics Loop diuretics Potassium-sparing diuretics Beta-blockers Sustained-release calcium channel blockers (CCBs) Alpha1-receptor blockers Sympatholytics"
315506|NCT01206062|O2|Outcome|Standard Control of SBP|"Participants randomized into the Standard arm had a goal of SBP <140 mm Hg. Intensify therapy if SBP ≥160 mm Hg @ 1 visit; ≥140 mm Hg @ 2 consecutive visits; Down-titration if SBP <130 mm Hg @ 1 visit; <135 mm Hg @ 2 consecutive visits~Standard control of SBP: The same medications used in the Intensive BP arm will be used for the Standard BP arm."
315507|NCT01206062|O1|Outcome|Intensive Control of SBP|"Participants randomized into the Intensive BP arm had a goal of SBP <120 mm Hg. 2-drug therapy initiated in most participants; age ≥75 years and SBP 130-139 mm Hg on 0-1 drug; may begin with 1 drug, but add second at 1 month if SBP ≥130 mm Hg; drugs added and/or titrated at each visit (monthly) to achieve SBP <120 mm Hg; at periodic visits: addition of another drug required if not at goal.~Intensive control of SBP: Use of once-daily antihypertensive agents was encouraged unless alternative frequency was necessary. One or more medications from the following classes of agents were provided by the study for use in managing participants in both groups to achieve study goals:~Angiotension converting enzyme (ACE)-inhibitors Angiotension receptor blockers (ARBs) Direct vasodilators Thiazide-type diuretics Loop diuretics Potassium-sparing diuretics Beta-blockers Sustained-release calcium channel blockers (CCBs) Alpha1-receptor blockers Sympatholytics"
315508|NCT01206062|E2|Reported Event|Standard Control of SBP|"Participants randomized into the Standard arm had a goal of SBP <140 mm Hg. Intensify therapy if SBP ≥160 mm Hg @ 1 visit; ≥140 mm Hg @ 2 consecutive visits; Down-titration if SBP <130 mm Hg @ 1 visit; <135 mm Hg @ 2 consecutive visits~Standard control of SBP: The same medications used in the Intensive BP arm will be used for the Standard BP arm."
315509|NCT01206062|E1|Reported Event|Intensive Control of SBP|"Participants randomized into the Intensive BP arm had a goal of SBP <120 mm Hg. 2-drug therapy initiated in most participants; age ≥75 years and SBP 130-139 mm Hg on 0-1 drug; may begin with 1 drug, but add second at 1 month if SBP ≥130 mm Hg; drugs added and/or titrated at each visit (monthly) to achieve SBP <120 mm Hg; at periodic visits: addition of another drug required if not at goal.~Intensive control of SBP: Use of once-daily antihypertensive agents was encouraged unless alternative frequency was necessary. One or more medications from the following classes of agents were provided by the study for use in managing participants in both groups to achieve study goals:~Angiotension converting enzyme (ACE)-inhibitors Angiotension receptor blockers (ARBs) Direct vasodilators Thiazide-type diuretics Loop diuretics Potassium-sparing diuretics Beta-blockers Sustained-release calcium channel blockers (CCBs) Alpha1-receptor blockers Sympatholytics"
315510|NCT01205828|B1|Baseline|Temozolomide + ABT-888|"Temozolomide and ABT-888~temozolomide + ABT-888: Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days~Patents with stable disease or continued response to therapy will be treated and followed for a total of 6 cycles (6 months)."
315511|NCT01205828|P1|Participant Flow|ABT-888 and Temozolomide|ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
315512|NCT01205828|O1|Outcome|Temozolomide and ABT-888 in HCC Patients|"Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days~Temozolomide: Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days~ABT-888: ABT-888 40 mg BID PO Days 1-7 every 28 days"
315513|NCT01205828|O1|Outcome|ABT-888 and Temozolomide|ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
315514|NCT01205828|O1|Outcome|ABT-888 and Temozolomide|ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
315515|NCT01205828|O1|Outcome|ABT-888 and Temozolomide|ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
315516|NCT01205828|O1|Outcome|ABT-888 and Temozolomide|ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
315517|NCT01205828|E1|Reported Event|Temozolomide + ABT-888|"Temozolomide and ABT-888~temozolomide + ABT-888: Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days~Patents with stable disease or continued response to therapy will be treated and followed for a total of 6 cycles (6 months)."
315518|NCT01205776|B3|Baseline|Total|Total of all reporting groups
315519|NCT01205776|B2|Baseline|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315520|NCT01205776|B1|Baseline|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315521|NCT01205776|P2|Participant Flow|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315522|NCT01205776|P1|Participant Flow|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315523|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315524|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315525|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315526|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315527|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315528|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315529|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315530|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315531|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315532|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315533|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315534|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315535|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315536|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315537|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315538|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315539|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315540|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315541|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315542|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315543|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315544|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315545|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315546|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315547|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315548|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315549|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315550|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315551|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315552|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315553|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315554|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315555|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315556|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315557|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315558|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315559|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315560|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315561|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315562|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315563|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315564|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315565|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315566|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315567|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315568|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315569|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315570|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315572|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315573|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315574|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315575|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315576|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315577|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315578|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315579|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315580|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315581|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315582|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315583|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315584|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315585|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315586|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315587|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315588|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315589|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315590|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315591|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315592|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315593|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315594|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315595|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315596|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315597|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315598|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315599|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315600|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315601|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315602|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315603|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315604|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315605|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315606|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315607|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315608|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315609|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315610|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315611|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315612|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315613|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315614|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315616|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315617|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315618|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315619|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315620|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315621|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315622|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315623|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315624|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315625|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315626|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315627|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315628|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315629|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315630|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315631|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315632|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315633|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315634|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315635|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315636|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315637|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315638|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315639|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315640|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315641|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315642|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315643|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315644|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315645|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315646|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315647|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315648|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315649|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315650|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315651|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315652|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315653|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315654|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315655|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315656|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315657|NCT01205776|O2|Outcome|Coronary Artery Bypass Graft (CABG)|Those patients receiving Coronary Artery Bypass Graft (CABG)
315658|NCT01205776|O1|Outcome|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315660|NCT01205776|E1|Reported Event|Percutaneous Coronary Intervention (PCI)|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
315661|NCT01205685|B1|Baseline|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)~Erlotinib in a pill form, by mouth, once a day~Letrozole in a pill form, by mouth, once a day~Goserelin, by injection once per month for women who are pre-menopausal"
315662|NCT01205685|P1|Participant Flow|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)~Erlotinib in a pill form, by mouth, once a day~Letrozole in a pill form, by mouth, once a day~Goserelin, by injection once per month for women who are pre-menopausal"
315663|NCT01205685|O1|Outcome|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)~Erlotinib in a pill form, by mouth, once a day~Letrozole in a pill form, by mouth, once a day~Goserelin, by injection once per month for women who are pre-menopausal"
315664|NCT01205685|O1|Outcome|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)~Erlotinib in a pill form, by mouth, once a day~Letrozole in a pill form, by mouth, once a day~Goserelin, by injection once per month for women who are pre-menopausal"
315665|NCT01205685|O1|Outcome|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)~Erlotinib in a pill form, by mouth, once a day~Letrozole in a pill form, by mouth, once a day~Goserelin, by injection once per month for women who are pre-menopausal"
315666|NCT01205685|O1|Outcome|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)~Erlotinib in a pill form, by mouth, once a day~Letrozole in a pill form, by mouth, once a day~Goserelin, by injection once per month for women who are pre-menopausal"
315667|NCT01205685|E1|Reported Event|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)~Erlotinib in a pill form, by mouth, once a day~Letrozole in a pill form, by mouth, once a day~Goserelin, by injection once per month for women who are pre-menopausal"
315668|NCT01205646|B1|Baseline|Zometa & PET Scans|"Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.~zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.~PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration."
315669|NCT01205646|P1|Participant Flow|Zometa & PET Scans|"Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.~zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.~PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration."
315670|NCT01205646|O1|Outcome|Zometa & PET Scans|"Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.~zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.~PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration."
315671|NCT01205646|O1|Outcome|Zometa & PET Scans|"Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.~zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.~PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration."
315672|NCT01205646|O1|Outcome|Zometa & PET Scans|"Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.~zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.~PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration."
315717|NCT01205581|O5|Outcome|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
315718|NCT01205581|O4|Outcome|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
315719|NCT01205581|O3|Outcome|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
315720|NCT01205581|O2|Outcome|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
315673|NCT01205646|O1|Outcome|Zometa & PET Scans|"Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.~zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.~PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration."
315674|NCT01205646|E1|Reported Event|Zometa & PET Scans|"Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.~zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.~PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration."
315675|NCT01205581|B7|Baseline|Total|Total of all reporting groups
315676|NCT01205581|B6|Baseline|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
315677|NCT01205581|B5|Baseline|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
315678|NCT01205581|B4|Baseline|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
315679|NCT01205581|B3|Baseline|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
315680|NCT01205581|B2|Baseline|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
315681|NCT01205581|B1|Baseline|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
315682|NCT01205581|P6|Participant Flow|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
315683|NCT01205581|P5|Participant Flow|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
315684|NCT01205581|P4|Participant Flow|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
315685|NCT01205581|P3|Participant Flow|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
315686|NCT01205581|P2|Participant Flow|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
315687|NCT01205581|P1|Participant Flow|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
315688|NCT01205581|O6|Outcome|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
315689|NCT01205581|O5|Outcome|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
315690|NCT01205581|O4|Outcome|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
315691|NCT01205581|O3|Outcome|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
315692|NCT01205581|O2|Outcome|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
315693|NCT01205581|O1|Outcome|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
315694|NCT01205581|O6|Outcome|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
315695|NCT01205581|O5|Outcome|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
315696|NCT01205581|O4|Outcome|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
315697|NCT01205581|O3|Outcome|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
315698|NCT01205581|O2|Outcome|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
315699|NCT01205581|O1|Outcome|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
315700|NCT01205581|O2|Outcome|Standard Dose Fluzone|42 participants received 82 doses of standard-dose Fluzone.
315701|NCT01205581|O1|Outcome|High-dose FluzoneHD|41 participants received 80 doses of high-dose FluzoneHD.
315702|NCT01205581|O2|Outcome|Standard Dose Fluzone|42 participants received 82 doses of standard-dose Fluzone.
315703|NCT01205581|O1|Outcome|High-dose FluzoneHD|41 participants received 80 doses of high-dose FluzoneHD.
315704|NCT01205581|O2|Outcome|Standard Dose Fluzone|42 participants received 82 doses of standard-dose Fluzone.
315705|NCT01205581|O1|Outcome|High-dose FluzoneHD|41 participants received 80 doses of high-dose FluzoneHD.
315706|NCT01205581|O2|Outcome|Standard Dose Fluzone|42 participants received 82 doses of standard-dose Fluzone.
315707|NCT01205581|O1|Outcome|High-dose FluzoneHD|41 participants received 80 doses of high-dose FluzoneHD.
315708|NCT01205581|O2|Outcome|ALC ≥1000 Cells/mm³|Participants whose ALC was ≥1000 cells/mm³ were analyzed.
315709|NCT01205581|O1|Outcome|ALC <1000 Cells/mm³|Participants whose ALC was <1000 cells/mm³ were analyzed.
315710|NCT01205581|O6|Outcome|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
315711|NCT01205581|O5|Outcome|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
315712|NCT01205581|O4|Outcome|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
315713|NCT01205581|O3|Outcome|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
315714|NCT01205581|O2|Outcome|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
315715|NCT01205581|O1|Outcome|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
315716|NCT01205581|O6|Outcome|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
315721|NCT01205581|O1|Outcome|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
315722|NCT01205581|O2|Outcome|ALC ≥1000 Cells/mm³|Participants whose ALC was ≥1000 cells/mm³ were analyzed.
315723|NCT01205581|O1|Outcome|ALC <1000 Cells/mm³|Participants whose ALC was <1000 cells/mm³ were analyzed.
315724|NCT01205581|O6|Outcome|HIV-2 Doses|Patients with a diagnosis of HIV who received 2 doses of high dose Fluzone SD.
315725|NCT01205581|O5|Outcome|HIV-1 Dose|Patients with a diagnosis of HIV who received one dose of high dose Fluzone SD.
315726|NCT01205581|O4|Outcome|Solid Tumor-2 Doses|Patients with a diagnosis of solid tumor who received 2 doses of high dose Fluzone SD.
315727|NCT01205581|O3|Outcome|Solid Tumor-1 Dose|Patients with a diagnosis of solid tumor who received one dose of high dose Fluzone SD.
315728|NCT01205581|O2|Outcome|Leukemia-2 Doses|Patients with a diagnosis of leukemia who received 2 doses of high dose Fluzone SD.
315729|NCT01205581|O1|Outcome|Leukemia-1 Dose|Patients with a diagnosis of leukemia who received one dose of high dose Fluzone SD.
315730|NCT01205581|O6|Outcome|HIV-2 Doses|Patients with a diagnosis of HIV who received 2 doses of high dose Fluzone HD.
315731|NCT01205581|O5|Outcome|HIV-1 Dose|Patients with a diagnosis of HIV who received one dose of high dose Fluzone HD.
315732|NCT01205581|O4|Outcome|Solid Tumor-2 Doses|Patients with a diagnosis of solid tumor who received 2 doses of high dose Fluzone HD.
315733|NCT01205581|O3|Outcome|Solid Tumor-1 Dose|Patients with a diagnosis of solid tumor who received one dose of high dose Fluzone HD.
315734|NCT01205581|O2|Outcome|Leukemia-2 Doses|Patients with a diagnosis of leukemia who received 2 doses of high dose Fluzone HD.
315735|NCT01205581|O1|Outcome|Leukemia-1 Dose|Patients with a diagnosis of leukemia who received one dose of high dose Fluzone HD.
315736|NCT01205581|O2|Outcome|Standard Dose Fluzone|42 participants received 82 doses of standard-dose Fluzone.
315737|NCT01205581|O1|Outcome|High-dose FluzoneHD|41 participants received 80 doses of high-dose FluzoneHD.
315738|NCT01205581|O6|Outcome|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
315739|NCT01205581|O5|Outcome|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
315740|NCT01205581|O4|Outcome|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
315741|NCT01205581|O3|Outcome|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
315742|NCT01205581|O2|Outcome|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
315743|NCT01205581|O1|Outcome|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
315744|NCT01205581|E6|Reported Event|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
315745|NCT01205581|E5|Reported Event|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
315746|NCT01205581|E4|Reported Event|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
315747|NCT01205581|E3|Reported Event|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
315748|NCT01205581|E2|Reported Event|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
315749|NCT01205581|E1|Reported Event|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
315750|NCT01205568|B1|Baseline|Patients With Resistant Pulmonary Artery Stenosis|"Vessels with resistant PA stenosis were identified during catheterization and eligible vessels were randomized to Cutting Balloon or High Pressure Balloon Dilation.~171 vessels in 73 patients were studied. Individual participants could have vessels randomized to one or both arms of the trial."
315751|NCT01205568|P2|Participant Flow|High Pressure Balloon (HPB)|Resistant Vessels with Pulmonary Artery Stenosis were identified during catheterization and vessels were randomized to High Pressure Balloon dilation.
315752|NCT01205568|P1|Participant Flow|Cutting Balloon (CB)|Resistant Vessels with Pulmonary Artery Stenosis were identified during catheterization and vessels were randomized to Cutting Balloon dilation.
315753|NCT01205568|O1|Outcome|Patients With Resistant Pulmonary Artery Stenosis|Vessels with resistant Pulmonary Artery Stenosis were identified during catheterization and eligible vessels were randomized to Cutting Balloon or High Pressure Balloon Dilation.
315754|NCT01205568|O1|Outcome|Patients With Resistant Pulmonary Artery Stenosis|Vessels with resistant Pulmonary Artery Stenosis were identified during catheterization and eligible vessels were randomized to Cutting Balloon or High Pressure Balloon Dilation.
315755|NCT01205568|E1|Reported Event|Patients With Resistant Pulmonary Artery Stenosis|Vessels with resistant Pulmonary Artery Stenosis were identified during catheterization and eligible vessels were randomized to Cutting Balloon (CB) or High Pressure Balloon Dilation (HPB). Of the 73 patients, 26 received CB dilation only, 8 patients received HPB dilation only, and 39 patients received both CB and HPB dilations. Therefore, 65/73 patients were exposed to CB and 47/73 patients were exposed to HPB. Due to the overlap in treatment amongst patients, adverse events are reported on the patient level and not by intervention type.
315756|NCT01205529|B1|Baseline|Atrial Fibrillation With ST Changes on Electrocardiogram|"Those patients with ST segment or J Point elevation on electrocardiogram. Can be on initial screening electrocardiogram or on electrocardiograms during procainamide infusion. These subjects will also have SCN5A mutation.~Procainamide: One time intravenous infusion of Procainamide administered over 30 minutes. Dosage is calculated as 10mg/kg based on subject's ideal body weight."
315757|NCT01205529|P1|Participant Flow|Atrial Fibrillation With ST Changes on Electrocardiogram|"Those patients with ST segment or J Point elevation on electrocardiogram. Can be on initial screening electrocardiogram or on electrocardiograms during procainamide infusion. These subjects will also have SCN5A mutation.~Procainamide: One time intravenous infusion of Procainamide administered over 30 minutes. Dosage is calculated as 10mg/kg based on subject's ideal body weight."
315758|NCT01205529|O1|Outcome|Atrial Fibrillation With ST Changes on Electrocardiogram|"Those patients with ST segment or J Point elevation on electrocardiogram. Can be on initial screening electrocardiogram or on electrocardiograms during procainamide infusion. These subjects will harbor cardiac sodium channel gene variants.~Procainamide: One time intravenous infusion of Procainamide administered over 30 minutes. Dosage is calculated as 10mg/kg based on subject's ideal body weight."
315759|NCT01205529|E1|Reported Event|Atrial Fibrillation With ST Changes on Electrocardiogram|"Those patients with ST segment or J Point elevation on electrocardiogram. Can be on initial screening electrocardiogram or on electrocardiograms during procainamide infusion. These subjects will also have SCN5A mutation.~Procainamide: One time intravenous infusion of Procainamide administered over 30 minutes. Dosage is calculated as 10mg/kg based on subject's ideal body weight."
315760|NCT01205503|B3|Baseline|Total|Total of all reporting groups
315761|NCT01205503|B2|Baseline|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 1, day 1. Infused over 15 minutes"
315762|NCT01205503|B1|Baseline|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 2, day 1. Infused over 15 minutes"
315763|NCT01205503|P2|Participant Flow|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 1, day 1. Infused over 15 minutes"
315764|NCT01205503|P1|Participant Flow|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 2, day 1. Infused over 15 minutes"
315765|NCT01205503|O2|Outcome|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
315766|NCT01205503|O1|Outcome|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
315767|NCT01205503|O2|Outcome|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
315768|NCT01205503|O1|Outcome|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
315769|NCT01205503|O2|Outcome|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
315770|NCT01205503|O1|Outcome|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
315771|NCT01205503|O2|Outcome|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
315772|NCT01205503|O1|Outcome|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
315773|NCT01205503|O2|Outcome|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
315774|NCT01205503|O1|Outcome|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
315775|NCT01205503|E2|Reported Event|Saline|"Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during cycle assigned by randomization~Infused over 15 minutes"
315776|NCT01205503|E1|Reported Event|Mesna|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during cycle assigned by randomization~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 2, day 1. Infused over 15 minutes"
315778|NCT01205451|B2|Baseline|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315779|NCT01205451|B1|Baseline|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315780|NCT01205451|P2|Participant Flow|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315781|NCT01205451|P1|Participant Flow|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315782|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315783|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315784|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315785|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315786|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315787|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315788|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315789|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315790|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315791|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315792|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315793|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315794|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315795|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315796|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315797|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315798|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315799|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315800|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315801|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315802|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315803|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315804|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315805|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315806|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315807|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315808|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315809|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315810|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315839|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
315840|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
315841|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
315811|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315812|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315813|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315814|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315815|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315816|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315817|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315818|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315819|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315820|NCT01205451|E2|Reported Event|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315821|NCT01205451|E1|Reported Event|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
315822|NCT01205399|B1|Baseline|AlloMax Surgical Graft Group|
315823|NCT01205399|P1|Participant Flow|AlloMax Surgical Graft Group|The study group included eligible subjects who underwent hernia repair using the AlloMax™ Surgical Graft at least 9 months prior to the start of this study.
315824|NCT01205399|O1|Outcome|AlloMax Surgical Graft Group|
315825|NCT01205399|O1|Outcome|AlloMax Surgical Graft Group|
315826|NCT01205399|O1|Outcome|AlloMax Surgical Graft Group|
315827|NCT01205399|E1|Reported Event|AlloMax Surgical Graft Group|
315828|NCT01205269|B1|Baseline|Entire Study Population|Includes all groups randomized to one of 6 sequences of drug or placebo.
315829|NCT01205269|P6|Participant Flow|First Placebo, Then 50 mcg, Then 200 mcg|period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg
315830|NCT01205269|P5|Participant Flow|First Placebo, Then 200 mcg, Then 50 mcg|period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg
315831|NCT01205269|P4|Participant Flow|First 200 mcg, Then 50 mcg, Then Placebo|period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo
315832|NCT01205269|P3|Participant Flow|First 200 mcg, Then Placebo, Then 50 mcg|period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg
315833|NCT01205269|P2|Participant Flow|First 50 mcg, Then Placebo, Then 200 mcg|period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg
315834|NCT01205269|P1|Participant Flow|First 50 mcg, Then 200 mcg, Then Placebo|period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: placebo
315835|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
315836|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
315837|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
315838|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
315842|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
315843|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
315844|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
315845|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
315846|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
315847|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
315848|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
315849|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
315850|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
315851|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
315852|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
315853|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
315854|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
315855|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
315856|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
315857|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
315858|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
315859|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
315860|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
315861|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
315862|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
315863|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
315864|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
315865|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
315866|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
315867|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
315868|NCT01205269|E3|Reported Event|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
315869|NCT01205269|E2|Reported Event|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
315870|NCT01205269|E1|Reported Event|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
315871|NCT01205230|B3|Baseline|Total|Total of all reporting groups
315872|NCT01205230|B2|Baseline|Pazopanib, Followed by Pazopanib + Esomeprazole|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1, followed by pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (approximately 3 hours after the evening meal) for 5 consecutive days during Period 2
315873|NCT01205230|B1|Baseline|Pazopanib, Followed by Pazopanib + Ketoconazole|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1, followed by ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
315874|NCT01205230|P2|Participant Flow|Pazopanib, Followed by Pazopanib + Esomeprazole|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1, followed by pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (approximately 3 hours after the evening meal) for 5 consecutive days during Period 2
315875|NCT01205230|P1|Participant Flow|Pazopanib, Followed by Pazopanib + Ketoconazole|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1, followed by ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
315876|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
315877|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
315878|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
315879|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
315880|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
315881|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
315882|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
315883|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
316371|NCT01203826|B2|Baseline|3 mg/kg Asfotase Alfa|Dose group shown is as per patient's randomization in Study ENB-006-09
315884|NCT01205230|O1|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1, followed by ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
315885|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
315886|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
315887|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
315888|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
315889|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
315890|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
315891|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
315892|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
315893|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
315894|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
315895|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
315896|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
315897|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
315898|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
315899|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
315900|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
315901|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
315902|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
315903|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
315904|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
315905|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
315906|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
315907|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
315908|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
315909|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
315910|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
315911|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
315912|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
315913|NCT01205230|E4|Reported Event|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
315914|NCT01205230|E3|Reported Event|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
315915|NCT01205230|E2|Reported Event|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
316372|NCT01203826|B1|Baseline|2 mg/kg Asfotase Alfa|Dose group shown is as per patient's randomization in Study ENB-006-09
315916|NCT01205230|E1|Reported Event|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
315917|NCT01205165|B1|Baseline|Adefovir Dipivoxil 10mg|The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks
315918|NCT01205165|P1|Participant Flow|Adefovir Dipivoxil 10mg|The eligible participants received open label treatment of 10 milligram (mg) Adefovir dipivoxil, orally once daily for 52-weeks
315919|NCT01205165|O1|Outcome|Adefovir Dipivoxil 10mg|The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks
315920|NCT01205165|O1|Outcome|Adefovir Dipivoxil 10mg|The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks
315921|NCT01205165|O1|Outcome|Adefovir Dipivoxil 10mg|The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks
315922|NCT01205165|O1|Outcome|Adefovir Dipivoxil 10mg|The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks
315923|NCT01205165|O1|Outcome|Adefovir Dipivoxil 10mg|The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks
315924|NCT01205165|O1|Outcome|Adefovir Dipivoxil 10mg|The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks
315925|NCT01205165|O1|Outcome|Adefovir Dipivoxil 10mg|The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks
315926|NCT01205165|O1|Outcome|Adefovir Dipivoxil 10mg|The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks
315927|NCT01205165|O1|Outcome|Adefovir Dipivoxil 10mg|The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks
315928|NCT01205165|O1|Outcome|Adefovir Dipivoxil 10mg|The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks.
315929|NCT01205165|E1|Reported Event|Adefovir Dipivoxil 10mg|The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks
315930|NCT01205152|B1|Baseline|Asfotase Alfa|An initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa, followed by subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times per week
315931|NCT01205152|P1|Participant Flow|Asfotase Alfa|An initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa, followed by subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times per week
315932|NCT01205152|O2|Outcome|Asfotase Alfa (Last Assessment)|Results at the last assessment in the ENB-003-08 study.
315933|NCT01205152|O1|Outcome|Asfotase Alfa (Baseline ENB-002-08)|Baseline results prior to treatment with asfotase alfa
315934|NCT01205152|O1|Outcome|Asfotase Alfa|An initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa, followed by subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times per week
315935|NCT01205152|O1|Outcome|Asfotase Alfa|An initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa, followed by subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times per week
315936|NCT01205152|O1|Outcome|Asfotase Alfa|An initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa, followed by subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times per week
315937|NCT01205152|O1|Outcome|Asfotase Alfa|An initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa, followed by subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times per week
315938|NCT01205152|O1|Outcome|Asfotase Alfa|An initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa, followed by subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times per week
315939|NCT01205152|O1|Outcome|Asfotase Alfa|An initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa, followed by subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times per week
315940|NCT01205152|E1|Reported Event|Asfotase Alfa|An initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa, followed by subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times per week
315941|NCT01205126|B3|Baseline|Total|Total of all reporting groups
315942|NCT01205126|B2|Baseline|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
315943|NCT01205126|B1|Baseline|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
315944|NCT01205126|P2|Participant Flow|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
315945|NCT01205126|P1|Participant Flow|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
315946|NCT01205126|O2|Outcome|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
315947|NCT01205126|O1|Outcome|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
315948|NCT01205126|O2|Outcome|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
315949|NCT01205126|O1|Outcome|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
316476|NCT01203072|P1|Participant Flow|DU-176b 5 mg|DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks
315950|NCT01205126|O2|Outcome|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
315951|NCT01205126|O1|Outcome|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
315952|NCT01205126|O2|Outcome|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
315953|NCT01205126|O1|Outcome|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
315954|NCT01205126|O2|Outcome|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
315955|NCT01205126|O1|Outcome|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
315956|NCT01205126|O2|Outcome|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
315957|NCT01205126|O1|Outcome|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
315958|NCT01205126|E2|Reported Event|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
315959|NCT01205126|E1|Reported Event|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
315960|NCT01205035|B3|Baseline|Total|Total of all reporting groups
315961|NCT01205035|B2|Baseline|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
315962|NCT01205035|B1|Baseline|Observation|Observation; No treatment given
315963|NCT01205035|P2|Participant Flow|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
315964|NCT01205035|P1|Participant Flow|Observation|Observation; No treatment given
315965|NCT01205035|O2|Outcome|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
315966|NCT01205035|O1|Outcome|Observation|Observation; No treatment given
315967|NCT01205035|O2|Outcome|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
315968|NCT01205035|O1|Outcome|Observation|Observation; No treatment given
315969|NCT01205035|O2|Outcome|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
315970|NCT01205035|O1|Outcome|Observation|Observation; No treatment given
315971|NCT01205035|O2|Outcome|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
315972|NCT01205035|O1|Outcome|Observation|Observation; No treatment given
315973|NCT01205035|O2|Outcome|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
315974|NCT01205035|O1|Outcome|Observation|Observation; No treatment given
315975|NCT01205035|E2|Reported Event|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
315976|NCT01205035|E1|Reported Event|Observation|Observation; No treatment given
315977|NCT01204918|B4|Baseline|Total|Total of all reporting groups
315978|NCT01204918|B3|Baseline|Placebo Addition to Standard SSRI Antidepressant|"Placebo will be added to ongoing SSRI or SNRI antidepressant treatment for 8 weeks~placebo: placebo"
315979|NCT01204918|B2|Baseline|Riluzole/Placebo Addition to SSRI Antidepressant|"Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 4 weeks and placebo will added to ongoing SSRI or SNRI antidepressant treatment for 4 weeks~Riluzole: Riluzole 100mg PO~placebo: placebo"
315980|NCT01204918|B1|Baseline|Riluzole Addition to SSRI Antidepressant|"Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 8 weeks~Riluzole: Riluzole 100mg PO"
315981|NCT01204918|P3|Participant Flow|Placebo Addition to Standard SSRI Antidepressant|"Placebo will be added to ongoing SSRI or SNRI antidepressant treatment for 8 weeks~placebo: placebo"
316477|NCT01203072|O5|Outcome|Placebo|Placebo: Matching placebo oral tablets, once daily for 2 weeks
315982|NCT01204918|P2|Participant Flow|Riluzole/Placebo Addition to SSRI Antidepressant|"Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 4 weeks and placebo will added to ongoing SSRI or SNRI antidepressant treatment for 4 weeks~Riluzole: Riluzole 100mg PO~placebo: placebo"
315983|NCT01204918|P1|Participant Flow|Riluzole Addition to SSRI Antidepressant|"Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 8 weeks~Riluzole: Riluzole 100mg PO"
315984|NCT01204918|O3|Outcome|Placebo Addition to Standard SSRI Antidepressant|"Placebo will be added to ongoing SSRI or SNRI antidepressant treatment for 8 weeks~placebo: placebo"
315985|NCT01204918|O2|Outcome|Riluzole/Placebo Addition to SSRI Antidepressant|"Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 4 weeks and placebo will added to ongoing SSRI or SNRI antidepressant treatment for 4 weeks~Riluzole: Riluzole 100mg PO~placebo: placebo"
315986|NCT01204918|O1|Outcome|Riluzole Addition to SSRI Antidepressant|"Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 8 weeks~Riluzole: Riluzole 100mg PO"
315987|NCT01204918|O3|Outcome|Placebo Addition to Standard SSRI Antidepressant|"Placebo will be added to ongoing SSRI or SNRI antidepressant treatment for 8 weeks~placebo: placebo"
315988|NCT01204918|O2|Outcome|Riluzole/Placebo Addition to SSRI Antidepressant|"Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 4 weeks and placebo will added to ongoing SSRI or SNRI antidepressant treatment for 4 weeks~Riluzole: Riluzole 100mg PO~placebo: placebo"
315989|NCT01204918|O1|Outcome|Riluzole Addition to SSRI Antidepressant|"Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 8 weeks~Riluzole: Riluzole 100mg PO"
315990|NCT01204918|O3|Outcome|Placebo Addition to Standard SSRI Antidepressant|"Placebo will be added to ongoing SSRI or SNRI antidepressant treatment for 8 weeks~placebo: placebo"
315991|NCT01204918|O2|Outcome|Riluzole/Placebo Addition to SSRI Antidepressant|"Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 4 weeks and placebo will added to ongoing SSRI or SNRI antidepressant treatment for 4 weeks~Riluzole: Riluzole 100mg PO~placebo: placebo"
315992|NCT01204918|O1|Outcome|Riluzole Addition to SSRI Antidepressant|"Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 8 weeks~Riluzole: Riluzole 100mg PO"
315993|NCT01204918|O3|Outcome|Placebo Addition to Standard SSRI Antidepressant|"Placebo will be added to ongoing SSRI or SNRI antidepressant treatment for 8 weeks~placebo: placebo"
315994|NCT01204918|O2|Outcome|Riluzole/Placebo Addition to SSRI Antidepressant|"Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 4 weeks and placebo will added to ongoing SSRI or SNRI antidepressant treatment for 4 weeks~Riluzole: Riluzole 100mg PO~placebo: placebo"
315995|NCT01204918|O1|Outcome|Riluzole Addition to SSRI Antidepressant|"Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 8 weeks~Riluzole: Riluzole 100mg PO"
315996|NCT01204918|E3|Reported Event|Placebo Addition to Standard SSRI Antidepressant|"Placebo will be added to ongoing SSRI or SNRI antidepressant treatment for 8 weeks~placebo: placebo"
315997|NCT01204918|E2|Reported Event|Riluzole/Placebo Addition to SSRI Antidepressant|"Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 4 weeks and placebo will added to ongoing SSRI or SNRI antidepressant treatment for 4 weeks~Riluzole: Riluzole 100mg PO~placebo: placebo"
315998|NCT01204918|E1|Reported Event|Riluzole Addition to SSRI Antidepressant|"Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 8 weeks~Riluzole: Riluzole 100mg PO"
315999|NCT01204853|B1|Baseline|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
316000|NCT01204853|P1|Participant Flow|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
316001|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
316002|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
316003|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
316004|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
316005|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
316006|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
316007|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
316078|NCT01204671|O1|Outcome|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316008|NCT01204853|E1|Reported Event|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
316009|NCT01204788|B3|Baseline|Total|Total of all reporting groups
316010|NCT01204788|B2|Baseline|Arm 2 (Therapeutic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)
316011|NCT01204788|B1|Baseline|Arm 1 (Prophylactic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
316012|NCT01204788|P2|Participant Flow|Arm 2 (Therapeutic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)
316013|NCT01204788|P1|Participant Flow|Arm 1 (Prophylactic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
316014|NCT01204788|O2|Outcome|Arm 2 (Therapeutic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)
316015|NCT01204788|O1|Outcome|Arm 1 (Prophylactic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
316016|NCT01204788|E2|Reported Event|Arm 2 (Therapeutic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)
316017|NCT01204788|E1|Reported Event|Arm 1 (Prophylactic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
316018|NCT01204775|B3|Baseline|Total|Total of all reporting groups
316019|NCT01204775|B2|Baseline|Placebo|Placebo matching saxagliptin
316020|NCT01204775|B1|Baseline|Saxagliptin|Saxagliptin 2.5 mg or 5 mg depending on body weight
316021|NCT01204775|P2|Participant Flow|Placebo|Placebo matching saxagliptin
316022|NCT01204775|P1|Participant Flow|Saxagliptin|Saxagliptin 2.5 mg or 5 mg depending on body weight
316023|NCT01204775|O2|Outcome|Placebo|Placebo matching saxagliptin
316024|NCT01204775|O1|Outcome|Saxagliptin|Saxagliptin 2.5 mg or 5 mg depending on body weight
316025|NCT01204775|E2|Reported Event|Saxagliptin|Saxagliptin 2.5 mg or 5 mg depending on body weight
316026|NCT01204775|E1|Reported Event|Placebo|Placebo matching saxagliptin
316027|NCT01204736|B5|Baseline|Total|Total of all reporting groups
316028|NCT01204736|B4|Baseline|Group 4|Unimpaired control subjects
316029|NCT01204736|B3|Baseline|Group 3|Subjects with cervical SCI who have not had tendon transfers
316030|NCT01204736|B2|Baseline|Group 2|Subjects with biceps-to-triceps tendon transfers
316031|NCT01204736|B1|Baseline|Group 1|Subjects with posterior deltoid-to-triceps tendon transfers
316032|NCT01204736|P4|Participant Flow|Group 4|Unimpaired control subjects
316033|NCT01204736|P3|Participant Flow|Group 3|Subjects with cervical SCI who have not had tendon transfers
316034|NCT01204736|P2|Participant Flow|Group 2|Subjects with biceps-to-triceps tendon transfers
316035|NCT01204736|P1|Participant Flow|Group 1|Subjects with posterior deltoid-to-triceps tendon transfers
316036|NCT01204736|O4|Outcome|Group 4|Unimpaired control subjects
316037|NCT01204736|O3|Outcome|Group 3|Subjects with cervical SCI who have not had tendon transfers
316038|NCT01204736|O2|Outcome|Group 2|Subjects with biceps-to-triceps tendon transfers
316039|NCT01204736|O1|Outcome|Group 1|Subjects with posterior deltoid-to-triceps tendon transfers
316040|NCT01204736|E4|Reported Event|Group 4|Unimpaired control subjects
316041|NCT01204736|E3|Reported Event|Group 3|Subjects with cervical SCI who have not had tendon transfers
316042|NCT01204736|E2|Reported Event|Group 2|Subjects with biceps-to-triceps tendon transfers
316043|NCT01204736|E1|Reported Event|Group 1|Subjects with posterior deltoid-to-triceps tendon transfers
316044|NCT01204697|B3|Baseline|Total|Total of all reporting groups
316045|NCT01204697|B2|Baseline|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
316046|NCT01204697|B1|Baseline|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
316047|NCT01204697|P2|Participant Flow|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 milligram per square meter (mg/m^2) as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
316048|NCT01204697|P1|Participant Flow|Erlotinib|Participants received erlotinib (Tarceva) at a dose of 150 milligram per day (mg/day) orally as monotherapy, up to progressive disease (PD), death, or unacceptable toxicity.
316049|NCT01204697|O2|Outcome|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
316050|NCT01204697|O1|Outcome|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
316478|NCT01203072|O4|Outcome|DU-176b 60 mg|DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks
316051|NCT01204697|O2|Outcome|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
316052|NCT01204697|O1|Outcome|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
316053|NCT01204697|O2|Outcome|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
316054|NCT01204697|O1|Outcome|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
316055|NCT01204697|O2|Outcome|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
316056|NCT01204697|O1|Outcome|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
316057|NCT01204697|O2|Outcome|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
316058|NCT01204697|O1|Outcome|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
316059|NCT01204697|O2|Outcome|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
316060|NCT01204697|O1|Outcome|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
316061|NCT01204697|E2|Reported Event|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
316062|NCT01204697|E1|Reported Event|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
316063|NCT01204671|B6|Baseline|Total|Total of all reporting groups
316064|NCT01204671|B5|Baseline|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316065|NCT01204671|B4|Baseline|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316066|NCT01204671|B3|Baseline|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316067|NCT01204671|B2|Baseline|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316068|NCT01204671|B1|Baseline|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316069|NCT01204671|P5|Participant Flow|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316070|NCT01204671|P4|Participant Flow|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316071|NCT01204671|P3|Participant Flow|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316072|NCT01204671|P2|Participant Flow|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316073|NCT01204671|P1|Participant Flow|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316074|NCT01204671|O5|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316075|NCT01204671|O4|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316076|NCT01204671|O3|Outcome|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316077|NCT01204671|O2|Outcome|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316479|NCT01203072|O3|Outcome|DU-176b 30 mg|DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks
316079|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316080|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316081|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316082|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316083|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
316084|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316085|NCT01204671|O5|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316086|NCT01204671|O4|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316087|NCT01204671|O3|Outcome|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316088|NCT01204671|O2|Outcome|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316089|NCT01204671|O1|Outcome|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316090|NCT01204671|O5|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316091|NCT01204671|O4|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316092|NCT01204671|O3|Outcome|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316093|NCT01204671|O2|Outcome|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316094|NCT01204671|O1|Outcome|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316095|NCT01204671|O5|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316096|NCT01204671|O4|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316097|NCT01204671|O3|Outcome|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316098|NCT01204671|O2|Outcome|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316099|NCT01204671|O1|Outcome|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316100|NCT01204671|O5|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316101|NCT01204671|O4|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316102|NCT01204671|O3|Outcome|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316103|NCT01204671|O2|Outcome|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316104|NCT01204671|O1|Outcome|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316105|NCT01204671|O5|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316106|NCT01204671|O4|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316107|NCT01204671|O3|Outcome|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316108|NCT01204671|O2|Outcome|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316109|NCT01204671|O1|Outcome|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316110|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316111|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316112|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316113|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316114|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316115|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316116|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316117|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316118|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316119|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316120|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316121|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316122|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316123|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316124|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316125|NCT01204671|E5|Reported Event|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316126|NCT01204671|E4|Reported Event|Fluarix Group|Subjects received one dose of the 1 dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316127|NCT01204671|E3|Reported Event|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316128|NCT01204671|E2|Reported Event|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316129|NCT01204671|E1|Reported Event|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
316130|NCT01204658|B5|Baseline|Total|Total of all reporting groups
316131|NCT01204658|B4|Baseline|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316132|NCT01204658|B3|Baseline|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316151|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316133|NCT01204658|B2|Baseline|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316134|NCT01204658|B1|Baseline|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316135|NCT01204658|P4|Participant Flow|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316136|NCT01204658|P3|Participant Flow|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316137|NCT01204658|P2|Participant Flow|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316138|NCT01204658|P1|Participant Flow|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316139|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316140|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316141|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316302|NCT01204203|O1|Outcome|Zometa|"Zometa (zoledronic acid) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.~Zometa: Zoledronic acid will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes."
316480|NCT01203072|O2|Outcome|DU-176b 15 mg|DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks
316142|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316143|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316144|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316145|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316146|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316147|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316148|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316149|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316150|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316303|NCT01204203|E1|Reported Event|Zoledronic Acid (Zometa)|Zoledronic acid (Zometa) will be administered IV-4mg by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles.The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.This will continue until progression of disease and/or intolerable toxicity.
316304|NCT01203956|B1|Baseline|All Evaluable Subjects|All subjects completing both two-week periods of crossover study, with evaluable results for each period.
316152|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316153|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316154|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316155|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316156|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316157|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316158|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316159|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316160|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316179|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316161|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316162|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316163|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316164|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316165|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316166|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316167|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316168|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316169|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316305|NCT01203956|P2|Participant Flow|Standard First, Then Smartflex|First two weeks without Smartflex engaged, second two weeks with Smartflex engaged
316306|NCT01203956|P1|Participant Flow|SmartFlex First, Then Standard|First two weeks with Smartflex engaged, second two weeks without Smartflex engaged
316307|NCT01203956|O2|Outcome|Standard|Used CPAP device without SmartFlex engaged, in either first or second two-week period.
316308|NCT01203956|O1|Outcome|SmartFlex|Used CPAP device with SmartFlex engaged, in either first or second two-week period.
316170|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316171|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316172|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316173|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316174|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316175|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316176|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316177|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316178|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316309|NCT01203956|E3|Reported Event||From data available it cannot be determined which mode the subject was using at the time of this event.
316310|NCT01203956|E2|Reported Event|Standard|CPAP device used without SmartFlex engaged, either in first or second two-week period.
316311|NCT01203956|E1|Reported Event|SmartFlex|CPAP device used with SmartFlex engaged, either in first or second two-week period.
316312|NCT01203930|B3|Baseline|Total|Total of all reporting groups
316481|NCT01203072|O1|Outcome|DU-176b 5 mg|DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks
316180|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316181|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316182|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316183|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316184|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316185|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316186|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316187|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316188|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316207|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316189|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316190|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316191|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316192|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316193|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316194|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316195|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316196|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316197|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316313|NCT01203930|B2|Baseline|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
316314|NCT01203930|B1|Baseline|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses. Participants who completed 12 cycles of idelalisib were eligible to continue treatment on an extension study (101-99).
316198|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316199|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316200|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316201|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316202|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316203|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316204|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316205|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316206|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316315|NCT01203930|P2|Participant Flow|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
316316|NCT01203930|P1|Participant Flow|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
316482|NCT01203072|O5|Outcome|Placebo|Placebo: Matching placebo oral tablets, once daily for 2 weeks
316208|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316209|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316210|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316211|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316212|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316213|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316214|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316215|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316216|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316235|NCT01204658|O2|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316217|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316218|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316219|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316220|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316221|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316222|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316223|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316224|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316225|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316299|NCT01204203|P1|Participant Flow|Zoledronic Acid (Zometa)|"Zoledronic acid (Zometa) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.~Zoledronic acid (Zometa) will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes."
316483|NCT01203072|O4|Outcome|DU-176b 60 mg|DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks
316226|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316227|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316228|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316229|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316230|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316231|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316232|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316233|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316234|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316300|NCT01204203|O1|Outcome|Zometa|"Zometa (zoledronic acid) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.~Zometa: Zoledronic acid will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes."
316484|NCT01203072|O3|Outcome|DU-176b 30 mg|DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks
316236|NCT01204658|O1|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316237|NCT01204658|O2|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316238|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316239|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316240|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316241|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316242|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316243|NCT01204658|E4|Reported Event|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
316244|NCT01204658|E3|Reported Event|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
316301|NCT01204203|O1|Outcome|Zometa|"Zometa (zoledronic acid) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.~Zometa: Zoledronic acid will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes."
316317|NCT01203930|O2|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
316245|NCT01204658|E2|Reported Event|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316246|NCT01204658|E1|Reported Event|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
316247|NCT01204398|B1|Baseline|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
316248|NCT01204398|P1|Participant Flow|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
316249|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
316250|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
316251|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
316252|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
316253|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
316254|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
316255|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
316256|NCT01204398|E1|Reported Event|T80/A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily
316257|NCT01204294|B8|Baseline|Total|Total of all reporting groups
316258|NCT01204294|B7|Baseline|A-GI+Met|alpha-glucosidase inhibitor plus metformin
316259|NCT01204294|B6|Baseline|SU+Met|sulfonylurea plus metformin
316260|NCT01204294|B5|Baseline|A-GI+Lina|alpha-glucosidase inhibitor plus linagliptin
316261|NCT01204294|B4|Baseline|SU+Lina|sulfonylurea plus linagliptin
316262|NCT01204294|B3|Baseline|Glit+Lina|glitazone plus linagliptin
316263|NCT01204294|B2|Baseline|Glin+Lina|glinide plus linagliptin
316264|NCT01204294|B1|Baseline|Bigu+Lina|biguanide plus linagliptin
316265|NCT01204294|P7|Participant Flow|A-GI+Met|alpha-glucosidase inhibitor plus metformin
316266|NCT01204294|P6|Participant Flow|SU+Met|sulfonylurea plus metformin
316267|NCT01204294|P5|Participant Flow|A-GI+Lina|alpha-glucosidase inhibitor plus linagliptin
316268|NCT01204294|P4|Participant Flow|SU+Lina|sulfonylurea plus linagliptin
316269|NCT01204294|P3|Participant Flow|Glit+Lina|glitazone plus linagliptin
316270|NCT01204294|P2|Participant Flow|Glin+Lina|glinide plus linagliptin
316271|NCT01204294|P1|Participant Flow|Bigu+Lina|biguanide plus linagliptin
316272|NCT01204294|O7|Outcome|A-GI+Met|alpha-glucosidase inhibitor plus metformin
316273|NCT01204294|O6|Outcome|SU+Met|sulfonylurea plus metformin
316274|NCT01204294|O5|Outcome|A-GI+Lina|alpha-glucosidase inhibitor plus linagliptin
316275|NCT01204294|O4|Outcome|SU+Lina|sulfonylurea plus linagliptin
316276|NCT01204294|O3|Outcome|Glit+Lina|glitazone plus linagliptin
316277|NCT01204294|O2|Outcome|Glin+Lina|glinide plus linagliptin
316278|NCT01204294|O1|Outcome|Bigu+Lina|biguanide plus linagliptin
316279|NCT01204294|O7|Outcome|A-GI+Met|alpha-glucosidase inhibitor plus metformin
316280|NCT01204294|O6|Outcome|SU+Met|sulfonylurea plus metformin
316281|NCT01204294|O5|Outcome|A-GI+Lina|alpha-glucosidase inhibitor plus linagliptin
316282|NCT01204294|O4|Outcome|SU+Lina|sulfonylurea plus linagliptin
316283|NCT01204294|O3|Outcome|Glit+Lina|glitazone plus linagliptin
316284|NCT01204294|O2|Outcome|Glin+Lina|glinide plus linagliptin
316285|NCT01204294|O1|Outcome|Bigu+Lina|biguanide plus linagliptin
316286|NCT01204294|E7|Reported Event|A-GI+Met|alpha-glucosidase inhibitor plus metformin
316287|NCT01204294|E6|Reported Event|SU+Met|sulfonylurea plus metformin
316288|NCT01204294|E5|Reported Event|A-GI+Lina|alpha-glucosidase inhibitor plus linagliptin
316289|NCT01204294|E4|Reported Event|SU+Lina|sulfonylurea plus linagliptin
316290|NCT01204294|E3|Reported Event|Glit+Lina|glitazone plus linagliptin
316291|NCT01204294|E2|Reported Event|Glin+Lina|glinide plus linagliptin
316292|NCT01204294|E1|Reported Event|Bigu+Lina|biguanide plus linagliptin
316293|NCT01204255|B1|Baseline|Arm I|Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
316294|NCT01204255|P1|Participant Flow|Arm I|Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
316295|NCT01204255|O1|Outcome|Application of Lorazepam, Diphenhydramine, Haloperidol|Topical application of lorazepam, diphenhydramine, haloperidol
316296|NCT01204255|O1|Outcome|Application of Lorazepam, Diphenhydramine, Haloperidol|Topical application of lorazepam, diphenhydramine, haloperidol
316297|NCT01204255|E1|Reported Event|Arm I|Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
316298|NCT01204203|B1|Baseline|Zoledronic Acid (Zometa)|Zometa (zoledronic acid) 4mg will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.
316348|NCT01203878|B3|Baseline|Non-Randomized|Imiquimod 3.75% applied to the entire face daily for up to 2 2-week cycles separated by a 2-week no treatment period,
316318|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses. Participants who completed 12 cycles of idelalisib were eligible to continue treatment on an extension study (101-99).
316319|NCT01203930|O2|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
316320|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses. Participants who completed 12 cycles of idelalisib were eligible to continue treatment on an extension study (101-99).
316321|NCT01203930|O1|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
316322|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
316323|NCT01203930|O2|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
316324|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
316325|NCT01203930|O2|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
316326|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
316327|NCT01203930|O2|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
316328|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
316329|NCT01203930|O2|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
316330|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
316331|NCT01203930|O2|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
316332|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
316333|NCT01203930|O2|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
316334|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
316335|NCT01203930|E2|Reported Event|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
316336|NCT01203930|E1|Reported Event|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
316337|NCT01203917|B1|Baseline|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
316338|NCT01203917|P1|Participant Flow|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
316339|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
316340|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
316341|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
316342|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
316343|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
316344|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
316345|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
316346|NCT01203917|E1|Reported Event|Gefitinib 250 mg|
316347|NCT01203878|B4|Baseline|Total|Total of all reporting groups
316349|NCT01203878|B2|Baseline|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
316350|NCT01203878|B1|Baseline|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
316351|NCT01203878|P3|Participant Flow|Non-randomized|Imiquimod 3.75% applied to the entire face daily for up to 2 2-week cycles separated by a 2-week no treatment period
316352|NCT01203878|P2|Participant Flow|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
316353|NCT01203878|P1|Participant Flow|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
316354|NCT01203878|O2|Outcome|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
316355|NCT01203878|O1|Outcome|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
316356|NCT01203878|O2|Outcome|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
316357|NCT01203878|O1|Outcome|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
316358|NCT01203878|O2|Outcome|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
316359|NCT01203878|O1|Outcome|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
316360|NCT01203878|E3|Reported Event|Non-Randomized|Imiquimod 3.75% applied to the entire face daily for up to 2 2-week cycles separated by a 2-week no treatment period.
316361|NCT01203878|E2|Reported Event|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
316362|NCT01203878|E1|Reported Event|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
316363|NCT01203852|B1|Baseline|Metoprolol + Chlorthalidone|"This group was assigned to the following: Metoprolol tartrate 50 mg twice daily for two weeks. After two weeks subjects will be seen in clinic and will have the dose doubled to 100 mg twice daily if either their HBP average or OBP is > 120/70 mmHg. They will continue on this dose for an additional 6 weeks. Then will washout from all study medication. After washout, participants will initiate chlorthalidone 25 mg four times per week (Monday, Wednesday, Thursday, Saturday) for two weeks, then 25 mg daily of chlorthalidone for 6 weeks.~Metoprolol: Metoprolol 50 mg twice daily titrated to 100 mg twice daily~Chlorthalidone: Chlorthalidone 25 mg 4 times per week titrated to 25 mg daily~Note: due to discontinuation of the manufacture of chlorthalidone 15 mg, effective Jan 1, 2013; the starting dose of chlorthalidone will be 25 mg 4 times per week (Mon, Wed, Thur, Sat) with subsequent titration to 25 mg daily."
316364|NCT01203852|P1|Participant Flow|Metoprolol + Chlorthalidone|"This group was assigned the following:~(Metoprolol 8 weeks): Metoprolol tartrate 50 mg twice daily for two weeks. After two weeks subjects will be seen in clinic and will have the dose doubled to 100 mg twice daily if either their home blood pressure (HBP) average or office blood pressure (OBP) is > 120/70 mmHg. They will continue on this dose for an additional 6 weeks.~(Washout 2 weeks): Then will washout from all study medication.~(Chlorthalidone 8 weeks): participants will initiate chlorthalidone 25 mg four times per week (Monday, Wednesday, Thursday, Saturday) for two weeks, then 25 mg daily of chlorthalidone for 6 weeks."
316365|NCT01203852|O1|Outcome|Adverse Metabolic Effects|Change in glucose after treatment with study medications
316366|NCT01203852|O3|Outcome|Chlorthalidone Only|Study participants were initiated on chlorthalidone 25 mg four days per week (Monday, Wednesday, Thursday, Saturday) 15 mg daily for two weeks, followed by 25 mg daily for an additional six weeks.
316367|NCT01203852|O2|Outcome|Metorprolol Only|Study participants had their current hypertension treatment withdrawn, baseline labs drawn and hypertension documented. Participants were initiated on metoprolol tartrate 50 mg twice daily for two weeks, followed by dose titration to 100 mg twice daily for six additional weeks if blood pressure (BP) > 120/70 mmHg. BP measures were again recorded.
316368|NCT01203852|O1|Outcome|Metoprolol + Chlorthalidone|Study participants had their current hypertension treatment withdrawn, baseline labs drawn and hypertension documented. Participants were initiated on metoprolol tartrate 50 mg twice daily for two weeks, followed by dose titration to 100 mg twice daily for six additional weeks if blood pressure (BP) > 120/70 mmHg. BP measures were again recorded. Participants entered a washout where metoprolol was titrated, then discontinued, and the patient’s hypertension was re-established. After another set of identical baseline labs, study participants were initiated on chlorthalidone 25 mg four days per week (Monday, Wednesday, Thursday, Saturday) 15 mg daily for two weeks, followed by 25 mg daily for an additional six weeks.
316369|NCT01203852|E1|Reported Event|All Study Participants|Study participants had their current hypertension treatment withdrawn, baseline labs drawn and hypertension documented. Participants were initiated on metoprolol tartrate 50 mg twice daily for two weeks, followed by dose titration to 100 mg twice daily for six additional weeks if blood pressure (BP) > 120/70 mmHg. BP measures were again recorded. Participants entered a washout where metoprolol was titrated, then discontinued, and the patient’s hypertension was re-established. The subjects were initiated on chlorthalidone 25 mg four days per week (Monday, Wednesday, Thursday, Saturday) 15 mg daily for two weeks, followed by 25 mg daily for an additional six weeks.
316370|NCT01203826|B3|Baseline|Total|Total of all reporting groups
316373|NCT01203826|P2|Participant Flow|3 mg/kg Asfotase Alfa|The starting dose of asfotase alfa was 3 mg/kg/week for all patients in Study ENB-008-10 and was subsequently increased per study-wide dose adjustment to a total dose of 6 mg/kg/week. Results are shown by the patient's dose group assignment from Study ENB-006-09.
316374|NCT01203826|P1|Participant Flow|2 mg/kg Asfotase Alfa|The starting dose of asfotase alfa was 3 mg/kg/week for all patients in Study ENB-008-10 and was subsequently increased per study-wide dose adjustment to a total dose of 6 mg/kg/week. Results are shown by the patient's dose group assignment from Study ENB-006-09.
316375|NCT01203826|O1|Outcome|Asfotase Alfa Combined|ITT population for Study ENB-008-10, which included all patients that received treatment with asfotase alfa.
316376|NCT01203826|E3|Reported Event|Combined Asfotase Alfa Group|All patients treated with asfotase alfa during Study ENB-008-10
316377|NCT01203826|E2|Reported Event|3 mg/kg Asfotase Alfa|Dose group shown is as per patient’s randomization in Study ENB-006-09.
316378|NCT01203826|E1|Reported Event|2 mg/kg Asfotase Alfa|Dose group shown is as per patient’s randomization in Study ENB-006-09.
316379|NCT01203787|B3|Baseline|Total|Total of all reporting groups
316380|NCT01203787|B2|Baseline|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13, 200 mg twice daily from Day 14-Day 20, 600 mg daily from Day 21-Day 27, 400 mg twice daily beginning Day 28 until end of treatment or Week 24
316381|NCT01203787|B1|Baseline|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
316382|NCT01203787|P2|Participant Flow|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
316383|NCT01203787|P1|Participant Flow|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
316384|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
316385|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
316386|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
316387|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
316388|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
316389|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
316390|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
316391|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
316392|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
316393|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
316394|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|"200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24~Sorafenib Standard Dosing Regimen: Sorafenib 400 mg twice daily until wk 24 or end of treatment"
316395|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|"Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24~Sorafenib Ramp-Up Regimen: 200 mg daily, Day 0-Day 13 200 mg twice daily, Day 14-Day 20 600 mg daily, Day 21-Day 27 400 mg twice daily, Day 28 until end of treatment400 mg twice daily"
316396|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
316397|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
316398|NCT01203787|E2|Reported Event|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
316399|NCT01203787|E1|Reported Event|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
316400|NCT01203644|B3|Baseline|Total|Total of all reporting groups
316401|NCT01203644|B2|Baseline|SKY0402|Low dose, low-mid dose, mid-dose, and high dose
316402|NCT01203644|B1|Baseline|Bupivacaine HCl|(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
316403|NCT01203644|P2|Participant Flow|SKY0402|Low dose, low-mid dose, mid-dose, and high dose
316404|NCT01203644|P1|Participant Flow|Bupivacaine HCl|(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
316405|NCT01203644|O5|Outcome|SKY0402 High Dose|Single administration of SKY0402 (high dose) in a 40-mL volume via local infiltration
316406|NCT01203644|O4|Outcome|SKY0402 High-mid Dose|Single administration of SKY0402 (high-mid dose) in a 40-mL volume via local infiltration
316407|NCT01203644|O3|Outcome|SKY0402 Low-mid Dose|Single administration of SKY0402 (low-mid dose) in a 40-mL volume via local infiltration
316408|NCT01203644|O2|Outcome|SKY0402 Low Dose|Single administration of SKY0402 (low dose) in a 40-mL volume via local infiltration
316409|NCT01203644|O1|Outcome|Bupivacaine HCl|(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402. Single 100 mg administration of 0.25% solution (i.e., 0.5% diluted 1:1) in a 40-mL volume via local infiltration
316410|NCT01203644|E2|Reported Event|SKY0402|Low dose, low-mid dose, mid-dose, and high dose
316411|NCT01203644|E1|Reported Event|Bupivacaine HCl|(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
316412|NCT01203319|B4|Baseline|Total|Total of all reporting groups
316413|NCT01203319|B3|Baseline|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
316414|NCT01203319|B2|Baseline|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
316415|NCT01203319|B1|Baseline|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
316416|NCT01203319|P3|Participant Flow|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
316417|NCT01203319|P2|Participant Flow|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
316418|NCT01203319|P1|Participant Flow|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
316419|NCT01203319|O3|Outcome|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
316420|NCT01203319|O2|Outcome|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
316421|NCT01203319|O1|Outcome|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
316422|NCT01203319|O3|Outcome|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
316423|NCT01203319|O2|Outcome|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
316424|NCT01203319|O1|Outcome|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
316425|NCT01203319|O3|Outcome|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
316426|NCT01203319|O2|Outcome|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
316427|NCT01203319|O1|Outcome|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
316428|NCT01203319|E3|Reported Event|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
316429|NCT01203319|E2|Reported Event|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
316430|NCT01203319|E1|Reported Event|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
316431|NCT01203189|B4|Baseline|Total|Total of all reporting groups
316432|NCT01203189|B3|Baseline|Cross Over Group|"Subjects in the Shampoo group will be able to cross over into the Foam group if the TDSS score does not improve by 60% at the end of the four week treatment period. These cross over subjects will remain in the study for an additional four weeks and apply foam in the same manner as subjects in the original Foam group.~ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks."
316433|NCT01203189|B2|Baseline|Foam Group|"Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.~ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks."
316434|NCT01203189|B1|Baseline|Shampoo Group|"Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.~ketoconazole 2% shampoo: Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo."
316435|NCT01203189|P3|Participant Flow|Shampoo First and Then Foam|subjects used shampoo for 4 weeks, but did not reach 60% improvement on TDSS score were given foam treatment for 4 weeks
316436|NCT01203189|P2|Participant Flow|Foam Only Group|"Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.~ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks."
316437|NCT01203189|P1|Participant Flow|Shampoo Only Group|"Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.~ketoconazole 2% shampoo: Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo."
316485|NCT01203072|O2|Outcome|DU-176b 15 mg|DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks
316438|NCT01203189|O3|Outcome|Cross Over Group|"Subjects in the Shampoo group will be able to cross over into the Foam group if the TDSS score does not improve by 60% at the end of the four week treatment period. These cross over subjects will remain in the study for an additional four weeks and apply foam in the same manner as subjects in the original Foam group.~ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks."
316439|NCT01203189|O2|Outcome|Foam Only Group|"Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.~ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks."
316440|NCT01203189|O1|Outcome|Shampoo Only Group|"Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.~ketoconazole 2% shampoo: Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo."
316441|NCT01203189|O3|Outcome|Cross Over Group|"Subjects in the Shampoo group will be able to cross over into the Foam group if the TDSS score does not improve by 60% at the end of the four week treatment period. These cross over subjects will remain in the study for an additional four weeks and apply foam in the same manner as subjects in the original Foam group.~ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks."
316442|NCT01203189|O2|Outcome|Foam Only Group|"Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.~ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks."
316443|NCT01203189|O1|Outcome|Shampoo Only Group|"Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.~ketoconazole 2% shampoo: Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo."
316444|NCT01203189|O3|Outcome|Cross Over Group|"Subjects in the Shampoo group will be able to cross over into the Foam group if the TDSS score does not improve by 60% at the end of the four week treatment period. These cross over subjects will remain in the study for an additional four weeks and apply foam in the same manner as subjects in the original Foam group.~ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks."
316445|NCT01203189|O2|Outcome|Foam Only Group|"Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.~ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks."
316446|NCT01203189|O1|Outcome|Shampoo Only Group|"Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.~ketoconazole 2% shampoo: Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo."
316447|NCT01203189|E3|Reported Event|Cross Over Group|"Subjects in the Shampoo group will be able to cross over into the Foam group if the TDSS score does not improve by 60% at the end of the four week treatment period. These cross over subjects will remain in the study for an additional four weeks and apply foam in the same manner as subjects in the original Foam group.~ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks."
316448|NCT01203189|E2|Reported Event|Foam Only Group|"Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.~ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks."
316449|NCT01203189|E1|Reported Event|Shampoo Only Group|"Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.~ketoconazole 2% shampoo: Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo."
316450|NCT01203098|B4|Baseline|Total|Total of all reporting groups
316451|NCT01203098|B3|Baseline|Enoxaparin Sodium 20mg (2000IU)|Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
316452|NCT01203098|B2|Baseline|DU-176b 30 mg|DU-176b 30 mg tablets oral, once daily for 2 weeks
316453|NCT01203098|B1|Baseline|DU-176b 15 mg|DU-176b 15 mg tablets, oral once daily for 2 weeks
316454|NCT01203098|P3|Participant Flow|Enoxaparin Sodium 20mg (2000IU)|Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
316455|NCT01203098|P2|Participant Flow|DU-176b 30 mg|DU-176b 30 mg tablets oral, once daily for 2 weeks
316456|NCT01203098|P1|Participant Flow|DU-176b 15 mg|DU-176b 15 mg tablets, oral once daily for 2 weeks
316457|NCT01203098|O3|Outcome|Enoxaparin Sodium 20mg (2000IU)|Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
316458|NCT01203098|O2|Outcome|DU-176b 30 mg|DU-176b 30 mg tablets oral, once daily for 2 weeks
316459|NCT01203098|O1|Outcome|DU-176b 15 mg|DU-176b 15 mg tablets, oral once daily for 2 weeks
316460|NCT01203098|O3|Outcome|Enoxaparin Sodium 20mg (2000IU)|Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
316461|NCT01203098|O2|Outcome|DU-176b 30 mg|DU-176b 30 mg tablets oral, once daily for 2 weeks
316462|NCT01203098|O1|Outcome|DU-176b 15 mg|DU-176b 15 mg tablets, oral once daily for 2 weeks
316463|NCT01203098|E3|Reported Event|Enoxaparin Sodium 20mg (2000IU)|Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
316464|NCT01203098|E2|Reported Event|DU-176b 30 mg|DU-176b 30 mg tablets oral, once daily for 2 weeks
316465|NCT01203098|E1|Reported Event|DU-176b 15 mg|DU-176b 15 mg tablets, oral once daily for 2 weeks
316466|NCT01203072|B6|Baseline|Total|Total of all reporting groups
316467|NCT01203072|B5|Baseline|Placebo|Placebo: Matching placebo oral tablets, once daily for 2 weeks
316468|NCT01203072|B4|Baseline|DU-176b 60 mg|DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks
316469|NCT01203072|B3|Baseline|DU-176b 30 mg|DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks
316470|NCT01203072|B2|Baseline|DU-176b 15 mg|DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks
316471|NCT01203072|B1|Baseline|DU-176b 5 mg|DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks
316472|NCT01203072|P5|Participant Flow|Placebo|Placebo: Matching placebo oral tablets, once daily for 2 weeks
316473|NCT01203072|P4|Participant Flow|DU-176b 60 mg|DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks
316474|NCT01203072|P3|Participant Flow|DU-176b 30 mg|DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks
316475|NCT01203072|P2|Participant Flow|DU-176b 15 mg|DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks
316487|NCT01203072|E5|Reported Event|Placebo|Placebo: Matching placebo oral tablets, once daily for 2 weeks
316488|NCT01203072|E4|Reported Event|DU-176b 60 mg|DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks
316489|NCT01203072|E3|Reported Event|DU-176b 30 mg|DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks
316490|NCT01203072|E2|Reported Event|DU-176b 15 mg|DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks
316491|NCT01203072|E1|Reported Event|DU-176b 5 mg|DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks
316492|NCT01203046|B3|Baseline|Total|Total of all reporting groups
316493|NCT01203046|B2|Baseline|GROUP B: 3 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group B will be treated with placebo during the following four days."
316494|NCT01203046|B1|Baseline|GROUP A: 7 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group A will be treated with Ertapenem during the following four days."
316495|NCT01203046|P2|Participant Flow|GROUP B: 3 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group B will be treated with placebo during the following four days."
316496|NCT01203046|P1|Participant Flow|GROUP A: 7 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group A will be treated with Ertapenem during the following four days."
316497|NCT01203046|O2|Outcome|GROUP B - 3 DAYS THERAPY|Patients with 3 days therapy
316498|NCT01203046|O1|Outcome|GROUP A - 7 DAYS THERAPY|Patients with 7 days therapy
316499|NCT01203046|O2|Outcome|GROUP B - 3 DAYS THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group B will be treated with placebo during the following four days."
316500|NCT01203046|O1|Outcome|GROUP A: 7 DAYS THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group A will be treated with Ertapenem during the following four days."
316501|NCT01203046|E2|Reported Event|GROUP B: 3 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group B will be treated with placebo during the following four days."
316502|NCT01203046|E1|Reported Event|GROUP A: 7 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group A will be treated with Ertapenem during the following four days."
316503|NCT01202994|B1|Baseline|Flute and pe|Participants receive a flutemetamol PET scan and two cognitive testing sessions across one week
316504|NCT01202994|P1|Participant Flow|Flute and pe|Participants receive a flutemetamol PET scan and two cognitive testing sessions across one week
316505|NCT01202994|O1|Outcome|Flute|"Flutemetamol PET scan.~18F-Flutemetamol: All subjects will undergo a PET scan with 18F-PIB, within six months of also undergoing an FDG-PET scan (PET scans will occur on separate days).~For the 18F-PIB PET scan: Approximately 185 MBq (5 mCi) of 18F-PIB will be injected intravenously and PET data collected for each subject.~The FDG-PET scan will follow the same procedures as routine scans obtained in a clinical setting (approximately 370 MBq of 18F-FDG will be injected intravenously and PET data collected for each subject). FDG-PET data will be used to correlate metabolic changes and for anatomic co-registration of 18F-PIB images."
316506|NCT01202994|O1|Outcome|Flute|"Flutemetamol PET scan.~18F-Flutemetamol: All subjects will undergo a PET scan with 18F-PIB. Approximately 185 MBq (5 mCi) of 18F-PIB will be injected intravenously and PET data collected for each subject."
316507|NCT01202994|E1|Reported Event|Flute and pe|Participants receive a flutemetamol PET scan and two cognitive testing sessions across one week
316508|NCT01202955|B3|Baseline|Total|Total of all reporting groups
316509|NCT01202955|B2|Baseline|Placebo First, Then Tolcapone|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
316510|NCT01202955|B1|Baseline|Tolcapone First, Then Placebo|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
316511|NCT01202955|P2|Participant Flow|Placebo First, Then Tolcapone|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
316512|NCT01202955|P1|Participant Flow|Tolcapone First, Then Placebo|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
316513|NCT01202955|O2|Outcome|Placebo First, Then Tolcapone|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
316514|NCT01202955|O1|Outcome|Tolcapone First, Then Placebo|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
316515|NCT01202955|O2|Outcome|Placebo First, Then Tolcapone|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
316516|NCT01202955|O1|Outcome|Tolcapone First, Then Placebo|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
316517|NCT01202955|O2|Outcome|Placebo First, Then Tolcapone|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
316518|NCT01202955|O1|Outcome|Tolcapone First, Then Placebo|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
316519|NCT01202955|E2|Reported Event|Placebo First, Then Tolcapone|"To maintain the study blind, both the active Tolcapone and placebo medication periods used an increased-titration dose. Below is the breakdown of the increase in dosing of the active Tolcapone:~Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally~During the placebo period, all participants followed the above dosing schedule; however, the capsules contained no tolcapone."
316520|NCT01202955|E1|Reported Event|Tolcapone First, Then Placebo|"To maintain the study blind, both the active Tolcapone and placebo medication periods used an increased-titration dose. Below is the breakdown of the increase in dosing of the active Tolcapone:~Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally~During the placebo period, all participants followed the above dosing schedule; however, the capsules contained no tolcapone."
316521|NCT01202903|B3|Baseline|Total|Total of all reporting groups
316522|NCT01202903|B2|Baseline|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
316523|NCT01202903|B1|Baseline|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
316524|NCT01202903|P2|Participant Flow|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
316525|NCT01202903|P1|Participant Flow|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
316526|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
316527|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
316528|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
316529|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
316530|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
316531|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
316532|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
316533|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
316534|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
316535|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
316536|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
316537|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
316538|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
316681|NCT01202760|O1|Outcome|120 mg LY2127399|LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
316539|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
316540|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
316541|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
316542|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
316543|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
316544|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
316545|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
316546|NCT01202903|E2|Reported Event|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
316547|NCT01202903|E1|Reported Event|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
316548|NCT01202877|B4|Baseline|Total|Total of all reporting groups
316549|NCT01202877|B3|Baseline|Phase II: 5-azacytidine + PKC412|AZA 75 mg/m^2 on days 1-7 and Midostaurin 50 mg bid orally on day 8-21 during the first cycle and continuously thereafter.
316550|NCT01202877|B2|Baseline|Phase I: 5-azacytidine + PKC412 50 mg|AZA 75 mg/m^2/day SQ or IV on days 1-7 of a 28 day cycle. PKC412 50 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
316551|NCT01202877|B1|Baseline|Phase I: 5-azacytidine + PKC412 25 mg|5-azacytidine (AZA) 75 mg/m^2/day subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 25 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
316552|NCT01202877|P3|Participant Flow|Phase II: 5-azacytidine + PKC412|AZA 75 mg/m^2 on days 1-7 and Midostaurin 50 mg bid orally on day 8-21 during the first cycle and continuously thereafter.
316553|NCT01202877|P2|Participant Flow|Phase I: 5-azacytidine + PKC412 50 mg|5-azacytidine 75 mg/m2/day subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 50 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
316554|NCT01202877|P1|Participant Flow|Phase I: 5-azacytidine + PKC412 25 mg|5-azacytidine 75 mg/m2/day subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 25 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
316555|NCT01202877|O1|Outcome|5-azacytidine + PKC412|"5-azacytidine 75 mg/m2/d subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 50 mg by mouth twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).~5-azacytidine: Starting dose: 75 mg/m2/d subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle.~PKC412: Starting dose: 50 mg by mouth twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily)."
316556|NCT01202877|O3|Outcome|Phase II: 5-azacytidine + PKC412|AZA 75 mg/m^2 on days 1-7 and PKC412 Midostaurin 50 mg bid orally on day 8-21 during the first cycle and continuously thereafter.
316557|NCT01202877|O2|Outcome|Phase I: 5-azacytidine + PKC412 50 mg|AZA 75 mg/m^2/day SQ or IV on days 1-7 of a 28 day cycle. PKC412 50 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
316558|NCT01202877|O1|Outcome|Phase I: 5-azacytidine + PKC412 25 mg|AZA 75 mg/m^2/day subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 25 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
316559|NCT01202877|E3|Reported Event|Phase II: 5-azacytidine + PKC412|AZA 75 mg/m^2 on days 1-7 and PKC412 Midostaurin 50 mg bid orally on day 8-21 during the first cycle and continuously thereafter.
316560|NCT01202877|E2|Reported Event|Phase I: 5-azacytidine + PKC412 50 mg|AZA 75 mg/m^2/day SQ or IV on days 1-7 of a 28 day cycle. PKC412 50 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
316561|NCT01202877|E1|Reported Event|Phase I: 5-azacytidine + PKC412 25 mg|AZA 75 mg/m^2/day subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 25 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
316562|NCT01202773|B4|Baseline|Total|Total of all reporting groups
316563|NCT01202773|B3|Baseline|Placebo|"A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.~At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period."
316564|NCT01202773|B2|Baseline|90 mg LY2127399|"A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks.~At Week 16, both responders and NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period."
316565|NCT01202773|B1|Baseline|120 mg LY2127399|"A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period."
316566|NCT01202773|P3|Participant Flow|Placebo|"A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.~At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period."
316567|NCT01202773|P2|Participant Flow|90 mg LY2127399|"A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks.~At Week 16, both responders and NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period."
316568|NCT01202773|P1|Participant Flow|120 mg LY2127399|"A loading dose of 240 milligrams (mg) (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered subcutaneously (SC) every 4 weeks (Q4W) for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks (Q2W).~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period."
316569|NCT01202773|O3|Outcome|Placebo|A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
316570|NCT01202773|O2|Outcome|90 mg LY2127399|A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
316571|NCT01202773|O1|Outcome|120 mg LY2127399|A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
316572|NCT01202773|O3|Outcome|Placebo|A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
316573|NCT01202773|O2|Outcome|90 mg LY2127399|A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
316574|NCT01202773|O1|Outcome|120 mg LY2127399|A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
316575|NCT01202773|O1|Outcome|120 mg LY2127399|"A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks or a loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period or 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period."
316576|NCT01202773|O3|Outcome|Placebo|A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
316577|NCT01202773|O2|Outcome|90 mg LY2127399|A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
316578|NCT01202773|O1|Outcome|120 mg LY2127399|A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
316579|NCT01202773|O3|Outcome|Placebo|A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
316618|NCT01202773|O3|Outcome|Placebo|A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
316580|NCT01202773|O2|Outcome|90 mg LY2127399|A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
316581|NCT01202773|O1|Outcome|120 mg LY2127399|A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
316582|NCT01202773|O3|Outcome|Placebo|A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
316583|NCT01202773|O2|Outcome|90 mg LY2127399|A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
316584|NCT01202773|O1|Outcome|120 mg LY2127399|A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
316585|NCT01202773|O3|Outcome|Placebo|A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
316586|NCT01202773|O2|Outcome|90 mg LY2127399|A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
316587|NCT01202773|O1|Outcome|120 mg LY2127399|A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
316588|NCT01202773|O3|Outcome|Placebo|A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
316589|NCT01202773|O2|Outcome|90 mg LY2127399|A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
316590|NCT01202773|O1|Outcome|120 mg LY2127399|A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
316591|NCT01202773|O3|Outcome|Placebo|A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
316592|NCT01202773|O2|Outcome|90 mg LY2127399|A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
316593|NCT01202773|O1|Outcome|120 mg LY2127399|A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
316594|NCT01202773|O3|Outcome|Placebo|A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
316595|NCT01202773|O2|Outcome|90 mg LY2127399|A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
316596|NCT01202773|O1|Outcome|120 mg LY2127399|A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
316597|NCT01202773|O3|Outcome|Placebo|A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
316598|NCT01202773|O2|Outcome|90 mg LY2127399|A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
316737|NCT01202643|O1|Outcome|G-CSF|G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
316599|NCT01202773|O1|Outcome|120 mg LY2127399|A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
316600|NCT01202773|O3|Outcome|Placebo|A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
316601|NCT01202773|O2|Outcome|90 mg LY2127399|A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
316602|NCT01202773|O1|Outcome|120 mg LY2127399|A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
316603|NCT01202773|O3|Outcome|Placebo|A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
316604|NCT01202773|O2|Outcome|90 mg LY2127399|A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
316605|NCT01202773|O1|Outcome|120 mg LY2127399|A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
316606|NCT01202773|O3|Outcome|Placebo|A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
316607|NCT01202773|O2|Outcome|90 mg LY2127399|A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
316608|NCT01202773|O1|Outcome|120 mg LY2127399|A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
316609|NCT01202773|O3|Outcome|Placebo|A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
316610|NCT01202773|O2|Outcome|90 mg LY2127399|A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
316611|NCT01202773|O1|Outcome|120 mg LY2127399|A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
316612|NCT01202773|O3|Outcome|Placebo|A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
316613|NCT01202773|O2|Outcome|90 mg LY2127399|A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
316614|NCT01202773|O1|Outcome|120 mg LY2127399|A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
316615|NCT01202773|O3|Outcome|Placebo|A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
316616|NCT01202773|O2|Outcome|90 mg LY2127399|A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
316617|NCT01202773|O1|Outcome|120 mg LY2127399|A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
316619|NCT01202773|O2|Outcome|90 mg LY2127399|A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
316620|NCT01202773|O1|Outcome|120 mg LY2127399|A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
316621|NCT01202773|O3|Outcome|Placebo|A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
316622|NCT01202773|O2|Outcome|90 mg LY2127399|A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period
316623|NCT01202773|O1|Outcome|120 mg LY2127399|A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
316624|NCT01202773|O3|Outcome|Placebo|A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
316625|NCT01202773|O2|Outcome|90 mg LY2127399|A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
316626|NCT01202773|O1|Outcome|120 mg LY2127399|A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
316627|NCT01202773|O3|Outcome|Placebo|A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
316628|NCT01202773|O2|Outcome|90 mg LY2127399|A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
316629|NCT01202773|O1|Outcome|120 mg LY2127399|A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
316630|NCT01202773|E11|Reported Event|Placebo to LY 90 mg Q2W (Week 16), Follow-up Period|"A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 16 weeks.~At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.~The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
316631|NCT01202773|E10|Reported Event|LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Follow-up Period|"A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 16 weeks. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.~The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
316632|NCT01202773|E9|Reported Event|Placebo, Follow-up Period|"A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.~The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
316633|NCT01202773|E8|Reported Event|LY 90 mg Q2W, Follow-up Period|"A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, both responders and NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.~The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
316634|NCT01202773|E7|Reported Event|LY 120 mg Q4W, Follow-up Period|"A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
316680|NCT01202760|O2|Outcome|90 mg LY2127399|LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
316635|NCT01202773|E6|Reported Event|Placebo, Rescue Period|"A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 16 weeks.~At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.~The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the treatment period for Week 16 NR."
316636|NCT01202773|E5|Reported Event|LY 90 mg Q2W, Rescue Period|"A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 16 weeks.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.~The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the treatment period for Week 16 NR."
316637|NCT01202773|E4|Reported Event|LY 120 mg Q4W, Rescue Period|"A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 16 weeks. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.~The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the treatment period for Week 16 NR."
316638|NCT01202773|E3|Reported Event|Placebo, Randomized Treatment Period|"A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.~The Randomized Treatment Period was defined as the time all data was collected during the treatment period, excluding the data collected after the date of the Week 16 injection for the Week 16 NR."
316639|NCT01202773|E2|Reported Event|LY 90 mg Q2W, Randomized Treatment Period|"A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.~The Randomized Treatment Period was defined as the time all data was collected during the treatment period, excluding the data collected after the date of the Week 16 injection for the Week 16 NR."
316640|NCT01202773|E1|Reported Event|LY 120 mg Q4W, Randomized Treatment Period|"A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~The Randomized Treatment Period was defined as the time all data was collected during the treatment period, excluding the data collected after the date of the Week 16 injection for the Week 16 NR."
316641|NCT01202760|B4|Baseline|Total|Total of all reporting groups
316642|NCT01202760|B3|Baseline|Placebo|"Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections of Placebo when initiating treatment.~After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period."
316643|NCT01202760|B2|Baseline|90 mg LY2127399|"LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180-mg (2 SC injections of 90 mg each) loading dose of LY2127399 when initiating treatment.~After 16 weeks, non-responders continued to receive 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period."
316644|NCT01202760|B1|Baseline|120 mg LY2127399|"LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240-mg (2 SC injections of 120 mg each) loading dose of LY2127399 when initiating treatment.~During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of Placebo every 2 weeks.~After 16 weeks, non-responders received 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period."
316645|NCT01202760|P3|Participant Flow|Placebo|"Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections of Placebo when initiating treatment.~After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period."
316646|NCT01202760|P2|Participant Flow|90 mg LY2127399|"LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180-mg (2 SC injections of 90 mg each) loading dose of LY2127399 when initiating treatment.~After 16 weeks, non-responders continued to receive 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period."
316647|NCT01202760|P1|Participant Flow|120 mg LY2127399|"LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240-mg (2 SC injections of 120 mg each) loading dose of LY2127399 when initiating treatment.~During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of Placebo every 2 weeks.~After 16 weeks, non-responders received 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period."
316648|NCT01202760|O3|Outcome|Placebo|"Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.~After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period."
316649|NCT01202760|O2|Outcome|90 mg LY2127399|"LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.~After 16 weeks, non-responders continued to receive 90 mg every 2 weeks for the rest of the 24-week Treatment Period."
316650|NCT01202760|O1|Outcome|120 mg LY2127399|"LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.~After 16 weeks, non-responders received 90 mg every 2 weeks for the rest of the 24-week Treatment Period."
316651|NCT01202760|O1|Outcome|LY2127399|"120 milligrams (mg) LY2127399: subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.~90 milligrams (mg) LY2127399: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.~After 16 weeks, non-responders received 90 mg every 2 weeks for the rest of the 24-week Treatment Period."
316652|NCT01202760|O3|Outcome|Placebo|"Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.~After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period."
316653|NCT01202760|O2|Outcome|90 mg LY2127399|"LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.~After 16 weeks, non-responders continued to receive 90 mg every 2 weeks for the rest of the 24-week Treatment Period."
316654|NCT01202760|O1|Outcome|120 mg LY2127399|"LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.~After 16 weeks, non-responders received 90 mg every 2 weeks for the rest of the 24-week Treatment Period."
316655|NCT01202760|O3|Outcome|Placebo|Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
316656|NCT01202760|O2|Outcome|90 mg LY2127399|LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
316657|NCT01202760|O1|Outcome|120 mg LY2127399|LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
316658|NCT01202760|O3|Outcome|Placebo|Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
316659|NCT01202760|O2|Outcome|90 mg LY2127399|LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
316660|NCT01202760|O1|Outcome|120 mg LY2127399|LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
316661|NCT01202760|O3|Outcome|Placebo|Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
316662|NCT01202760|O2|Outcome|90 mg LY2127399|LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
316663|NCT01202760|O1|Outcome|120 mg LY2127399|LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
316664|NCT01202760|O3|Outcome|Placebo|Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
316665|NCT01202760|O2|Outcome|90 mg LY2127399|LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
316666|NCT01202760|O1|Outcome|120 mg LY2127399|LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
316667|NCT01202760|O3|Outcome|Placebo|"Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.~After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period."
316668|NCT01202760|O2|Outcome|90 mg LY2127399|"LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.~After 16 weeks, non-responders continued to receive 90 mg every 2 weeks for the rest of the 24-week Treatment Period."
316669|NCT01202760|O1|Outcome|120 mg LY2127399|"LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.~After 16 weeks, non-responders received 90 mg every 2 weeks for the rest of the 24-week Treatment Period."
316670|NCT01202760|O3|Outcome|Placebo|"Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.~After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period."
316671|NCT01202760|O2|Outcome|90 mg LY2127399|"LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.~After 16 weeks, non-responders continued to receive 90 mg every 2 weeks for the rest of the 24-week Treatment Period."
316672|NCT01202760|O1|Outcome|120 mg LY2127399|"LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.~After 16 weeks, non-responders received 90 mg every 2 weeks for the rest of the 24-week Treatment Period."
316673|NCT01202760|O3|Outcome|Placebo|Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
316674|NCT01202760|O2|Outcome|90 mg LY2127399|LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
316675|NCT01202760|O1|Outcome|120 mg LY2127399|LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
316676|NCT01202760|O3|Outcome|Placebo|Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
316677|NCT01202760|O2|Outcome|90 mg LY2127399|LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
316678|NCT01202760|O1|Outcome|120 mg LY2127399|LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
316679|NCT01202760|O3|Outcome|Placebo|Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
316682|NCT01202760|O3|Outcome|Placebo|Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
316683|NCT01202760|O2|Outcome|90 mg LY2127399|LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
316684|NCT01202760|O1|Outcome|120 mg LY2127399|LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
316685|NCT01202760|O3|Outcome|Placebo|Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
316686|NCT01202760|O2|Outcome|90 mg LY2127399|LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
316687|NCT01202760|O1|Outcome|120 mg LY2127399|LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
316688|NCT01202760|O3|Outcome|Placebo|Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
316689|NCT01202760|O2|Outcome|90 mg LY2127399|LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
316690|NCT01202760|O1|Outcome|120 mg LY2127399|LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
316691|NCT01202760|O3|Outcome|Placebo|Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
316692|NCT01202760|O2|Outcome|90 mg LY2127399|LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
316693|NCT01202760|O1|Outcome|120 mg LY2127399|LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
316694|NCT01202760|O3|Outcome|Placebo|Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
316695|NCT01202760|O2|Outcome|90 mg LY2127399|LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
316696|NCT01202760|O1|Outcome|120 mg LY2127399|LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
316697|NCT01202760|O3|Outcome|Placebo|Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
316698|NCT01202760|O2|Outcome|90 mg LY2127399|LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
316699|NCT01202760|O1|Outcome|120 mg LY2127399|LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
316700|NCT01202760|O3|Outcome|Placebo|Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
316701|NCT01202760|O2|Outcome|90 mg LY2127399|LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
316702|NCT01202760|O1|Outcome|120 mg LY2127399|LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
316703|NCT01202760|E11|Reported Event|Placebo to 90 mg LY2127399 (Week 16), Follow-up Period|"Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.~After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.~The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
316704|NCT01202760|E10|Reported Event|120 mg LY2127399 to 90 mg LY212739 (Week 16), Follow-up Period|"LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.~During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks.~After 16 weeks, non-responders received 90 mg every 2 weeks for the rest of the 24-week Treatment Period.~The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
316705|NCT01202760|E9|Reported Event|Placebo, Follow-up Period|"Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.~The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
316706|NCT01202760|E8|Reported Event|90 mg LY2127399, Follow-up Period|"LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.~The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
316707|NCT01202760|E7|Reported Event|120 mg LY2127399, Follow-up Period|"LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.~During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks.~The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
316708|NCT01202760|E6|Reported Event|Placebo, Rescue Period|"Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.~After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.~The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the Treatment Period for Week 16 non-responders."
316709|NCT01202760|E5|Reported Event|90 mg LY2127399, Rescue Period|"LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.~After 16 weeks, non-responders continued to receive 90 mg every 2 weeks for the rest of the 24-week Treatment Period.~The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the Treatment Period for Week 16 non-responders."
316710|NCT01202760|E4|Reported Event|120 mg LY2127399, Rescue Period|"LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.~During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks.~After 16 weeks, non-responders received 90 mg every 2 weeks for the rest of the 24-week Treatment Period.~The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the Treatment Period for Week 16 non-responders."
316711|NCT01202760|E3|Reported Event|Placebo, Randomized Treatment Period|"Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.~The Randomized Treatment Period was defined as the time all data was collected during the Treatment Period, excluding the data collected after the date of the Week 16 injection for the Week 16 non-responders."
316712|NCT01202760|E2|Reported Event|90 mg LY2127399, Randomized Treatment Period|"LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.~The Randomized Treatment Period was defined as the time all data was collected during the Treatment Period, excluding the data collected after the date of the Week 16 injection for the Week 16 non-responders."
316713|NCT01202760|E1|Reported Event|120 mg LY2127399, Randomized Treatment Period|"LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.~During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks.~The Randomized Treatment Period was defined as the time all data was collected during the Treatment Period, excluding the data collected after the date of the Week 16 injection for the Week 16 non-responders."
316714|NCT01202747|B1|Baseline|LipiFlow Treatment|Treatment with LipiFlow device
316715|NCT01202747|P1|Participant Flow|LipiFlow Treatment|Treatment with LipiFlow device
316716|NCT01202747|O1|Outcome|LipiFlow Treatment|Treatment with LipiFlow device
316717|NCT01202747|E1|Reported Event|LipiFlow Treatment|Treatment with LipiFlow device
316718|NCT01202656|B3|Baseline|Total|Total of all reporting groups
316719|NCT01202656|B2|Baseline|Saline Then G-CSF|"Normal Saline~Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation~then~G-CSF (Granulocyte colony stimulating factor)~G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation"
316720|NCT01202656|B1|Baseline|G-CSF Then Saline|"G-CSF (Granulocyte colony stimulating factor)~G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation~then~Normal Saline~Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation"
316721|NCT01202656|P2|Participant Flow|Saline Then G-CSF|"Normal Saline~Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation"
316722|NCT01202656|P1|Participant Flow|G-CSF Then Saline|"G-CSF (Granulocyte colony stimulating factor)~G-CSF 300 units administered by trans-cervical infusion one time on day of human chorionic gonadotropin(hCG) trigger for Ovulation"
316723|NCT01202656|O2|Outcome|Saline|"Normal Saline~Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation"
316724|NCT01202656|O1|Outcome|G-CSF|"G-CSF (Granulocyte colony stimulating factor)~G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation"
316725|NCT01202656|O2|Outcome|Saline|"Normal Saline~Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation"
316726|NCT01202656|O1|Outcome|G-CSF|"G-CSF (Granulocyte colony stimulating factor)~G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation"
316727|NCT01202656|E2|Reported Event|Saline|"Normal Saline~Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation"
316728|NCT01202656|E1|Reported Event|G-CSF|"G-CSF (Granulocyte colony stimulating factor)~G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation"
316729|NCT01202643|B3|Baseline|Total|Total of all reporting groups
316730|NCT01202643|B2|Baseline|Saline Then G-CSF|Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation then G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
316731|NCT01202643|B1|Baseline|G-CSF Then Saline|G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation then Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
316732|NCT01202643|P2|Participant Flow|Saline Then G-CSF|Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation then G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
316733|NCT01202643|P1|Participant Flow|G-CSF Then Saline|G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation then Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
316734|NCT01202643|O2|Outcome|Saline|Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
316735|NCT01202643|O1|Outcome|G-CSF|G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
316736|NCT01202643|O2|Outcome|Saline|Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
318032|NCT01198574|O4|Outcome|Placebo Group|2.5 mg folic acid + Vitamin A placebo
316738|NCT01202643|E2|Reported Event|Saline|Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
316739|NCT01202643|E1|Reported Event|G-CSF|G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
316740|NCT01202591|B7|Baseline|Total|Total of all reporting groups
316741|NCT01202591|B6|Baseline|Part B: Placebo + Fulvestrant|80 mg Placebo BD + 500 mg Fulvestrant
316742|NCT01202591|B5|Baseline|Part B: AZD4547 + Fulvestrant|80 mg AZD4547 BD + 500 mg Fulvestrant
316743|NCT01202591|B4|Baseline|AZD4547 80mg bd 2w/1w + Ex 25mg|80 mg AZD4547 bd two week on/one week off + 25 mg exemestane
316744|NCT01202591|B3|Baseline|AZD4547 80mg bd 1w/1w + Ex 25mg|80 mg AZD4547 BD one week on/one week off + 25 mg exemestane
316745|NCT01202591|B2|Baseline|AZD4547 40mg bd Cont + Ex 25mg|40 mg AZD4547 BD continuous + 25 mg exemestane
316746|NCT01202591|B1|Baseline|AZD4547 80mg bd Cont + Ex 25mg|80 mg AZD4547 bd continuous + 25 mg exemestane
316747|NCT01202591|P6|Participant Flow|Part B: Placebo + Fulvestrant|80mg Placebo BD + 500 mg Fulvestrant
316748|NCT01202591|P5|Participant Flow|Part B: AZD4547 + Fulvestrant|80 mg AZD4547 BD + 500 mg Fulvestrant
316749|NCT01202591|P4|Participant Flow|AZD4547 80mg bd 2w/1w + Ex|80 mg AZD4547 BD two week on/one week off + 25 mg exemestane
316750|NCT01202591|P3|Participant Flow|AZD4547 80mg bd 1w/1w + Ex 25mg|80 mg AZD4547 bd one week on/one week off + 25 mg exemestane
316751|NCT01202591|P2|Participant Flow|AZD4547 40mg Cont + Ex 25mg|40 mg AZD4547 BD continuous + 25 mg exemestane
316752|NCT01202591|P1|Participant Flow|AZD4547 80mg bd Cont + Ex 25mg|80 mg AZD4547 BD continuous + 25 mg exemestane
316753|NCT01202591|O6|Outcome|Part B: Placebo + Fulvestrant|80mg Placebo BD + 500 mg Fulvestrant
316754|NCT01202591|O5|Outcome|Part B: AZD4547 + Fulvestrant|80 mg AZD4547 BD + 500 mg Fulvestrant
316755|NCT01202591|O4|Outcome|AZD4547 80mg bd 2w/1w + Ex 25mg|80 mg AZD4547 BD two week on/one week off + 25 mg exemestane
316756|NCT01202591|O3|Outcome|AZD4547 80mg bd 1w/1w + Ex 25mg|80 mg AZD4547 bd one week on/one week off + 25 mg exemestane
316757|NCT01202591|O2|Outcome|AZD4547 40mg Cont + Ex 25mg|40 mg AZD4547 BD continuous + 25 mg exemestane
316758|NCT01202591|O1|Outcome|AZD4547 80mg bd Cont + Ex 25mg|80 mg AZD4547 BD continuous + 25 mg exemestane
316759|NCT01202591|E6|Reported Event|Part B: Placebo + Fulvestrant|80 mg Placebo BD + 500 mg Fulvestrant
316760|NCT01202591|E5|Reported Event|Part B: AZD4547 + Fulvestrant|80 mg AZD4547 BD + 500 mg Fulvestrant
316761|NCT01202591|E4|Reported Event|AZD4547 80mg bd 2w/1w + Ex 25mg|80 mg AZD4547 bd two week on/one week off + 25 mg exemestane
316762|NCT01202591|E3|Reported Event|AZD4547 80mg bd 1w/1w + Ex 25mg|80 mg AZD4547 BD one week on/one week off + 25 mg exemestane
316763|NCT01202591|E2|Reported Event|AZD4547 40mg bd Cont + Ex 25mg|40 mg AZD4547 BD continuous + 25 mg exemestane
316764|NCT01202591|E1|Reported Event|AZD4547 80mg bd Cont + Ex 25mg|80 mg AZD4547 bd continuous + 25 mg exemestane
316765|NCT01202578|B1|Baseline|Tympanostomy Tube Placement Using the Tube Delivery System|
316766|NCT01202578|P1|Participant Flow|Tympanostomy Tube Placement Using the Tube Delivery System|
316767|NCT01202578|O1|Outcome|Tympanostomy Tube Placement Using the Tube Delivery System|
316768|NCT01202578|O1|Outcome|Tympanostomy Tube Placement Using the Tube Delivery System|
316769|NCT01202578|O1|Outcome|Tympanostomy Tube Placement Using the Tube Delivery System|
316770|NCT01202578|O1|Outcome|Tympanostomy Tube Placement Using the Tube Delivery System|
316771|NCT01202578|E1|Reported Event|Safety Events|Safety in terms of number affected subjects in total number of subjects.
316772|NCT01202565|B1|Baseline|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
316773|NCT01202565|P1|Participant Flow|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
316774|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
316775|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
316776|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
316777|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
316778|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
316779|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
316780|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
316781|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
316782|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
316783|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
316784|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
316785|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
316786|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
316787|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
316788|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
316789|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
316790|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
316791|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
316792|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
316793|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
316794|NCT01202565|E1|Reported Event|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
316795|NCT01202279|B3|Baseline|Total|Total of all reporting groups
316796|NCT01202279|B2|Baseline|Placebo|Placebo given bid with a full glass of water for 7 days
316797|NCT01202279|B1|Baseline|Mucinex D|Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
316798|NCT01202279|P2|Participant Flow|Placebo|Placebo given bid with a full glass of water for 7 days
316799|NCT01202279|P1|Participant Flow|Mucinex D|Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
316800|NCT01202279|O2|Outcome|Placebo|Placebo given bid with a full glass of water for 7 days
316801|NCT01202279|O1|Outcome|Mucinex D|Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
316802|NCT01202279|O2|Outcome|Placebo|Placebo given bid with a full glass of water for 7 days
316803|NCT01202279|O1|Outcome|Mucinex D|Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
316804|NCT01202279|E2|Reported Event|Placebo|Placebo given bid with a full glass of water for 7 days
316805|NCT01202279|E1|Reported Event|Mucinex D|Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
316806|NCT01202253|B1|Baseline|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
316807|NCT01202253|P1|Participant Flow|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
316808|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316809|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316810|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316811|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316812|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316813|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316814|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316815|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316816|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316817|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316818|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316819|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316820|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316821|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316822|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316823|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316824|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316825|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316826|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316827|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316828|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316829|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316830|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316831|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316832|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316833|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316834|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316835|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316836|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316837|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316838|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316839|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
316840|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
316841|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316842|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
316843|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
316844|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
316845|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316846|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316847|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
316848|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
316849|NCT01202253|E1|Reported Event|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
316850|NCT01202227|B1|Baseline|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
316851|NCT01202227|P1|Participant Flow|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
316974|NCT01202188|O2|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
316852|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
316853|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
316854|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
316855|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
316856|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
316857|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
316858|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
316859|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
316860|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
316861|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
316862|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
316863|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
316864|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
316865|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
316866|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
316867|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
316868|NCT01202227|E1|Reported Event|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
316869|NCT01202188|B6|Baseline|Total|Total of all reporting groups
316870|NCT01202188|B5|Baseline|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316871|NCT01202188|B4|Baseline|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316872|NCT01202188|B3|Baseline|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316873|NCT01202188|B2|Baseline|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316874|NCT01202188|B1|Baseline|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316875|NCT01202188|P5|Participant Flow|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316876|NCT01202188|P4|Participant Flow|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316877|NCT01202188|P3|Participant Flow|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316878|NCT01202188|P2|Participant Flow|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316879|NCT01202188|P1|Participant Flow|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316880|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316881|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316882|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316883|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316884|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
318460|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
316885|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316886|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316887|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316888|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316889|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316890|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316891|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316892|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316893|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316894|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316895|NCT01202188|O4|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
316896|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via a SDDPI for 26 weeks.Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
316897|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
316898|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
316899|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316900|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316901|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316902|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316903|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316904|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316905|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316906|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316929|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316907|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316908|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316909|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316910|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316911|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316912|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316913|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316914|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316915|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316916|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316917|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316918|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316919|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316920|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316921|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316922|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316923|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316924|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316925|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316926|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316927|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316928|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
317054|NCT01201915|P1|Participant Flow|Cohort 1: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
316930|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316931|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316932|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316933|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316934|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316935|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316936|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316937|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316938|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316939|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316940|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316941|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316942|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316943|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316944|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316945|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316946|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316947|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316948|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316949|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316950|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316951|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
317026|NCT01201967|P2|Participant Flow|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis"
316952|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316953|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316954|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316955|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316956|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316957|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316958|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316959|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316960|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316961|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316962|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316963|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316964|NCT01202188|O2|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via the manufacturer's proprietary device for 26 weeks.Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
316965|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
316966|NCT01202188|O4|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
316967|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via a SDDPI for 26 weeks.Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
316968|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
316969|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
316970|NCT01202188|O2|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
316971|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
316972|NCT01202188|O2|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
316973|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
317028|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
316975|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
316976|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via a SDDPI for 26 weeks.Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
316977|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
316978|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
316979|NCT01202188|E5|Reported Event|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316980|NCT01202188|E4|Reported Event|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316981|NCT01202188|E3|Reported Event|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316982|NCT01202188|E2|Reported Event|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316983|NCT01202188|E1|Reported Event|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
316984|NCT01202162|B3|Baseline|Total|Total of all reporting groups
316985|NCT01202162|B2|Baseline|Sevoflurane|Administration of Sevoflurane
316986|NCT01202162|B1|Baseline|Desflurane|Administration of Desflurane
316987|NCT01202162|P2|Participant Flow|Sevoflurane|Administration of Sevoflurane
316988|NCT01202162|P1|Participant Flow|Desflurane|Administration of Desflurane
316989|NCT01202162|O2|Outcome|Sevoflurane|Administration of Sevoflurane
316990|NCT01202162|O1|Outcome|Desflurane|Administration of Desflurane
316991|NCT01202162|O2|Outcome|Sevoflurane|Administration of Sevoflurane
316992|NCT01202162|O1|Outcome|Desflurane|Administration of Desflurane
316993|NCT01202162|O2|Outcome|Sevoflurane|Administration of Sevoflurane
316994|NCT01202162|O1|Outcome|Desflurane|Administration of Desflurane
316995|NCT01202162|E2|Reported Event|Sevoflurane|Administration of Sevoflurane
316996|NCT01202162|E1|Reported Event|Desflurane|Administration of Desflurane
316997|NCT01202110|B1|Baseline|Control|Control
316998|NCT01202110|P2|Participant Flow|Propranolol|Propranolol
316999|NCT01202110|P1|Participant Flow|Control|Control
317000|NCT01202110|O1|Outcome|Propranolol|0
317001|NCT01202110|E1|Reported Event|Control|10
317002|NCT01202071|B1|Baseline|Entire Study Population: Group A, Group B, Group C, Group D|"Includes Group A, Group B, Group C, and Group D. Participants received Rabeprazole sodium Tablets for 5 days in each period.~Group A Period I: 5 mg, Period II: 10 mg, Period III: 20 mg, Period IV: 40 mg~Group B Period I: 10 mg, Period II: 20 mg, Period III: 40 mg, Period IV: 5 mg~Group C Period I: 20 mg, Period II: 40 mg, Period III: 5 mg, Period IV: 10 mg~Group D Period I: 40 mg, Period II: 5 mg, Period III: 10 mg, Period IV: 20 mg~Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV, a washout period consisted of 6 days or longer between each period."
317003|NCT01202071|P4|Participant Flow|Group D: Rapeprazole 40 mg, Then 5 mg, Then 10 mg, Then 20 mg|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Period I (9 days total): 40 mg; Period II (8 days total): 5 mg; Period III (8 days total): 10 mg; Period IV (8 days total): 20 mg~Each Period was separated by a >= 6 day washout period.~Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge."
317004|NCT01202071|P3|Participant Flow|Group C: Rapeprazole 20 mg, Then 40 mg, Then 5 mg, Then 10 mg|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Period I (9 days total): 20 mg; Period II (8 days total): 40 mg; Period III (8 days total): 5 mg; Period IV (8 days total): 10 mg~Each Period was separated by a >= 6 day washout period.~Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge."
317005|NCT01202071|P2|Participant Flow|Group B: Rapeprazole 10 mg, Then 20 mg, Then 40 mg, Then 5 mg|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Period I (9 days total): 10 mg; Period II (8 days total): 20 mg; Period III (8 days total): 40 mg; Period IV (8 days total): 5 mg~Each Period was separated by a >= 6 day washout period.~Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge."
317027|NCT01201967|P1|Participant Flow|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
317006|NCT01202071|P1|Participant Flow|Group A: Rapeprazole 5 mg, Then 10 mg, Then 20 mg, Then 40 mg|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Period I (9 days total): 5 mg; Period II (8 days total): 10 mg; Period III (8 days total): 20 mg; Period IV (8 days total): 40 mg~Each Period was separated by a >= 6 day washout period.~Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge."
317007|NCT01202071|O4|Outcome|Rabeprazole Sodium 40 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 40 mg was received by:~Group A in Period IV; Group B in Period III; Group C in Period II; Group D in Period I"
317008|NCT01202071|O3|Outcome|Rabeprazole Sodium 20 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 20 mg was received by:~Group A in Period III; Group B in Period II; Group C in Period I; Group D in Period IV"
317009|NCT01202071|O2|Outcome|Rabeprazole Sodium 10 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 10 mg was received by:~Group A in Period II; Group B in Period I; Group C in Period IV; Group D in Period III"
317010|NCT01202071|O1|Outcome|Rabeprazole Sodium 5 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 5 mg was received by:~Group A in Period I; Group B in Period IV; Group C in Period III; Group D in Period II"
317011|NCT01202071|O4|Outcome|Rabeprazole Sodium 40 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 40 mg was received by:~Group A in Period IV; Group B in Period III; Group C in Period II; Group D in Period I"
317012|NCT01202071|O3|Outcome|Rabeprazole Sodium 20 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 20 mg was received by:~Group A in Period III; Group B in Period II; Group C in Period I; Group D in Period IV"
317013|NCT01202071|O2|Outcome|Rabeprazole Sodium 10 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 10 mg was received by:~Group A in Period II; Group B in Period I; Group C in Period IV; Group D in Period III"
317014|NCT01202071|O1|Outcome|Rabeprazole Sodium 5 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 5 mg was received by:~Group A in Period I; Group B in Period IV; Group C in Period III; Group D in Period II"
317015|NCT01202071|O4|Outcome|Rabeprazole Sodium 40 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 40 mg was received by:~Group A in Period IV; Group B in Period III; Group C in Period II; Group D in Period I"
317016|NCT01202071|O3|Outcome|Rabeprazole Sodium 20 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 20 mg was received by:~Group A in Period III; Group B in Period II; Group C in Period I; Group D in Period IV"
317017|NCT01202071|O2|Outcome|Rabeprazole Sodium 10 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 10 mg was received by:~Group A in Period II; Group B in Period I; Group C in Period IV; Group D in Period III"
317018|NCT01202071|O1|Outcome|Rabeprazole Sodium 5 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 5 mg was received by:~Group A in Period I; Group B in Period IV; Group C in Period III; Group D in Period II"
317019|NCT01202071|E4|Reported Event|Rabeprazole Sodium 40 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 40 mg was received by:~Group A in Period IV; Group B in Period III; Group C in Period II; Group D in Period I"
317020|NCT01202071|E3|Reported Event|Rabeprazole Sodium 20 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 20 mg was received by:~Group A in Period III; Group B in Period II; Group C in Period I; Group D in Period IV"
317021|NCT01202071|E2|Reported Event|Rabeprazole Sodium 10 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 10 mg was received by:~Group A in Period II; Group B in Period I; Group C in Period IV; Group D in Period III"
317022|NCT01202071|E1|Reported Event|Rabeprazole Sodium 5 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 5 mg was received by:~Group A in Period I; Group B in Period IV; Group C in Period III; Group D in Period II"
317023|NCT01201967|B3|Baseline|Total|Total of all reporting groups
317024|NCT01201967|B2|Baseline|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis"
317025|NCT01201967|B1|Baseline|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
317029|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
317030|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
317031|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
317032|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
317033|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
317034|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis"
317035|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
317036|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
317037|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
317038|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis"
317039|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
317040|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
317041|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
317042|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
317043|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
317044|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
317045|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
317046|NCT01201967|E2|Reported Event|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis"
317047|NCT01201967|E1|Reported Event|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
317048|NCT01201915|B4|Baseline|Total|Total of all reporting groups
317049|NCT01201915|B3|Baseline|Cohort 3: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
317050|NCT01201915|B2|Baseline|Cohort 2: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
317051|NCT01201915|B1|Baseline|Cohort 1: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
317052|NCT01201915|P3|Participant Flow|Cohort 3: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
317053|NCT01201915|P2|Participant Flow|Cohort 2: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
317055|NCT01201915|O3|Outcome|Cohort 3: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
317056|NCT01201915|O2|Outcome|Cohort 2: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
317057|NCT01201915|O1|Outcome|Cohort 1: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
317058|NCT01201915|O3|Outcome|Cohort 3: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
317059|NCT01201915|O2|Outcome|Cohort 2: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
317060|NCT01201915|O1|Outcome|Cohort 1: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
317061|NCT01201915|E3|Reported Event|Cohort 3: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
317062|NCT01201915|E2|Reported Event|Cohort 2: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
317063|NCT01201915|E1|Reported Event|Cohort 1: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
317064|NCT01201811|B1|Baseline|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
317065|NCT01201811|P1|Participant Flow|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
317066|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
317067|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
317068|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
317069|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
317070|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
317071|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
317072|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
317073|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
317074|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
317075|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
317076|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
317077|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
317078|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
317079|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
317080|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
317081|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
317082|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
317083|NCT01201811|E1|Reported Event|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
317084|NCT01201798|B3|Baseline|Total|Total of all reporting groups
317085|NCT01201798|B2|Baseline|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
317086|NCT01201798|B1|Baseline|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
317087|NCT01201798|P2|Participant Flow|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
317088|NCT01201798|P1|Participant Flow|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
317089|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
317090|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
317091|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
317092|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
317093|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
317094|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
317095|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
317096|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
317097|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
317098|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
317164|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
317099|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
317100|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
317101|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
317102|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
317103|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
317104|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
317105|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
317106|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
317107|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
317108|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
317109|NCT01201798|E2|Reported Event|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
317110|NCT01201798|E1|Reported Event|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
317111|NCT01201785|B1|Baseline|Aspirin Dose Range|Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
317112|NCT01201785|P1|Participant Flow|Aspirin Dose Range|Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
317113|NCT01201785|O1|Outcome|Aspirin Dose Range|Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
317114|NCT01201785|E1|Reported Event|Aspirin Dose Range|Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
317115|NCT01201772|B4|Baseline|Total|Total of all reporting groups
317116|NCT01201772|B3|Baseline|Prasugrel 60mg|Prasugrel was administered as six 10 mg tablets
317117|NCT01201772|B2|Baseline|Prasugrel 30mg|Prasugrel was administered as three 10 mg tablets
317118|NCT01201772|B1|Baseline|Prasugrel 10mg|Prasugrel was administered as one 10 mg tablet
317119|NCT01201772|P3|Participant Flow|Prasugrel 60mg|Prasugrel was administered as six 10 mg tablet
317120|NCT01201772|P2|Participant Flow|Prasugrel 30mg|Prasugrel was administered as three 10 mg tablet
317121|NCT01201772|P1|Participant Flow|Prasugrel 10mg|Prasugrel was administered as one 10 mg tablet
317122|NCT01201772|O3|Outcome|Prasugrel 60mg|Prasugrel was administered as six 10 mg tablets
317123|NCT01201772|O2|Outcome|Prasugrel 30mg|Prasugrel was administered as three 10 mg tablets
317124|NCT01201772|O1|Outcome|Prasugrel 10mg|Prasugrel was administered as one 10 mg tablet
317125|NCT01201772|E1|Reported Event|All Study Participants|All participants who received prasugrel
317126|NCT01201759|B3|Baseline|Total|Total of all reporting groups
317127|NCT01201759|B2|Baseline|Salsalate to Placebo 2gr BID|"Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days.~Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2"
317128|NCT01201759|B1|Baseline|Placebo to Salsalate 2gr BID|"Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.~Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2."
317129|NCT01201759|P2|Participant Flow|Salsalate to Placebo 2gr BID|"Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days.~Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2"
317130|NCT01201759|P1|Participant Flow|Placebo to Salsalate 2gr BID|"Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.~Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2."
317165|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
317166|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
318461|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
317131|NCT01201759|O2|Outcome|Salsalate|Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2
317132|NCT01201759|O1|Outcome|Placebo|Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2.
317133|NCT01201759|O2|Outcome|Salsalate|Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2
317134|NCT01201759|O1|Outcome|Placebo|Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2.
317135|NCT01201759|O2|Outcome|Salsalate|Drug: Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2
317136|NCT01201759|O1|Outcome|Placebo|Placebo 2 grams twice a day for 30 days. Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2.
317137|NCT01201759|O2|Outcome|Salsalate|Drug: Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2
317138|NCT01201759|O1|Outcome|Placebo|Placebo 2 grams twice a day for 30 days. Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2.
317139|NCT01201759|E2|Reported Event|Salsalate 2gr BID|Salsalate 2grams twice a day for 30 days.
317140|NCT01201759|E1|Reported Event|Placebo 2gr BID|Placebo twice a day for 30 days.
317141|NCT01201629|B3|Baseline|Total|Total of all reporting groups
317142|NCT01201629|B2|Baseline|Sham|8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
317143|NCT01201629|B1|Baseline|Experimental (tDCs)|t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation
317144|NCT01201629|P2|Participant Flow|Sham|8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
317145|NCT01201629|P1|Participant Flow|Experimental (tDCs)|t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation
317146|NCT01201629|O2|Outcome|Sham|8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
317147|NCT01201629|O1|Outcome|Experimental (tDCs)|t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation
317148|NCT01201629|O2|Outcome|Sham|8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
317149|NCT01201629|O1|Outcome|Experimental (tDCs)|t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation
317150|NCT01201629|O2|Outcome|Sham|8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
317151|NCT01201629|O1|Outcome|Experimental (tDCs)|t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation
317152|NCT01201629|E2|Reported Event|Sham|8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
317153|NCT01201629|E1|Reported Event|Experimental (tDCs)|t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation
317154|NCT01201486|B1|Baseline|Pregnant Women in Second Trimester|Pregnant females in the 2nd trimester.
317155|NCT01201486|P1|Participant Flow|Pregnant Women in Second Trimester|Pregnant females in the 2nd trimester.
317156|NCT01201486|O1|Outcome|Pregnant Women|Pregnant females in the 2nd trimester.
317157|NCT01201486|E1|Reported Event|Pregnant Women|Pregnant females in the 2nd trimester.
317158|NCT01201343|B1|Baseline|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
317159|NCT01201343|P1|Participant Flow|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
317160|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
317161|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
317162|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
317163|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
318462|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
317167|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
317168|NCT01201343|E1|Reported Event|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
317169|NCT01201317|B4|Baseline|Total|Total of all reporting groups
317170|NCT01201317|B3|Baseline|Placebo|tablets, once daily in the morning
317171|NCT01201317|B2|Baseline|AZD2423 20 mg|tablets, 20 mg once daily in the morning
317172|NCT01201317|B1|Baseline|AZD2423 150 mg|tablets, 150 mg once daily in the morning
317173|NCT01201317|P3|Participant Flow|Placebo|tablets, once daily in the morning
317174|NCT01201317|P2|Participant Flow|AZD2423 20 mg|tablets, 20 mg once daily in the morning
317175|NCT01201317|P1|Participant Flow|AZD2423 150 mg|tablets, 150 mg once daily in the morning
317176|NCT01201317|O3|Outcome|Placebo|tablets, once daily in the morning
317177|NCT01201317|O2|Outcome|AZD2423 20 mg|tablets, 20 mg once daily in the morning
317178|NCT01201317|O1|Outcome|AZD2423 150 mg|tablets, 150 mg once daily in the morning
317179|NCT01201317|O3|Outcome|Placebo|tablets, once daily in the morning
317180|NCT01201317|O2|Outcome|AZD2423 20 mg|tablets, 20 mg once daily in the morning
317181|NCT01201317|O1|Outcome|AZD2423 150 mg|tablets, 150 mg once daily in the morning
317182|NCT01201317|O3|Outcome|Placebo|tablets, once daily in the morning
317183|NCT01201317|O2|Outcome|AZD2423 20 mg|tablets, 20 mg once daily in the morning
317184|NCT01201317|O1|Outcome|AZD2423 150 mg|tablets, 150 mg once daily in the morning
317185|NCT01201317|O3|Outcome|Placebo|tablets, once daily in the morning
317186|NCT01201317|O2|Outcome|AZD2423 20 mg|tablets, 20 mg once daily in the morning
317187|NCT01201317|O1|Outcome|AZD2423 150 mg|tablets, 150 mg once daily in the morning
317188|NCT01201317|O3|Outcome|Placebo|tablets, once daily in the morning
317189|NCT01201317|O2|Outcome|AZD2423 20 mg|tablets, 20 mg once daily in the morning
317190|NCT01201317|O1|Outcome|AZD2423 150 mg|tablets, 150 mg once daily in the morning
317191|NCT01201317|E3|Reported Event|Placebo|tablets, once daily in the morning
317192|NCT01201317|E2|Reported Event|AZD2423 20 mg|tablets, 20 mg once daily in the morning
317193|NCT01201317|E1|Reported Event|AZD2423 150 mg|tablets, 150 mg once daily in the morning
317194|NCT01201265|B1|Baseline|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
317195|NCT01201265|P1|Participant Flow|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
317196|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
317197|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
317198|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
317199|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
317200|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
317201|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
317202|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
317203|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
317204|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
317205|NCT01201265|E1|Reported Event|All Particiapants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
317206|NCT01200992|B3|Baseline|Total|Total of all reporting groups
317207|NCT01200992|B2|Baseline|Mitomycin C|"40 mg mitomycin C mixed with water for injection to a total volume of 40 mL~Mitomycin C: Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12"
317208|NCT01200992|B1|Baseline|EN3348|"8 mg EN3348 mixed with water for injection for a total volume of 50mL~EN3348: Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12"
317580|NCT01199965|P1|Participant Flow|Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result.
317209|NCT01200992|P2|Participant Flow|Mitomycin C|"40 mg mitomycin C mixed with water for injection to a total volume of 40 mL~Mitomycin C: Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12"
317210|NCT01200992|P1|Participant Flow|EN3348|"8 mg EN3348 mixed with water for injection for a total volume of 50mL~EN3348: Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12"
317211|NCT01200992|O2|Outcome|Mitomycin C|"40 mg mixed with sterile water for injection to a total volume of 40 mL~Treatment - Induction (6 weekly instillations) followed by Maintenance (monthly instillations up to Month 12)"
317212|NCT01200992|O1|Outcome|EN3348|"8 mg mixed with sterile water for injection for a total volume of 50mL~Treatment - Induction (6 weekly instillations) followed by Maintenance (monthly instillations up to Month 12)"
317213|NCT01200992|O2|Outcome|Mitomycin C|"40 mg mixed with water for injection to a total volume of 40 mL~Treatment - Induction (6 weekly instillations) followed Maintenance (monthly instillations up to Month 12)"
317214|NCT01200992|O1|Outcome|EN3348|"8 mg mixed with water for injection for a total volume of 50mL~Treatment - Induction (6 weekly instillations) followed Maintenance (monthly instillations up to Month 12)"
317215|NCT01200992|E2|Reported Event|Mitomycin C|"40 mg mixed with sterile water for injection to a total volume of 40 mL~Treatment - Induction (6 weekly instillations) followed by Maintenance (monthly instillations up to Month 12)"
317216|NCT01200992|E1|Reported Event|EN3348|"8 mg mixed with sterile water for injection for a total volume of 50mL~Treatment - Induction (6 weekly instillations) followed by Maintenance (monthly instillations up to Month 12)"
317217|NCT01200875|B1|Baseline|Treatment Arm|All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
317218|NCT01200875|P1|Participant Flow|PRP Injection (All Patients)|All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
317219|NCT01200875|O1|Outcome|PRP Injection (All Patients)|All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
317220|NCT01200875|E1|Reported Event|Treatment Arm|All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
317221|NCT01200810|B3|Baseline|Total|Total of all reporting groups
317222|NCT01200810|B2|Baseline|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
317223|NCT01200810|B1|Baseline|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
317224|NCT01200810|P2|Participant Flow|Arm II - RO4929097|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
317225|NCT01200810|P1|Participant Flow|Arm I - Placebo|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
317226|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
317227|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
317228|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
317229|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
317230|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
317231|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
317232|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
317233|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
317234|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
317235|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
317236|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
317237|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
317238|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
317239|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
317240|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
317241|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
317242|NCT01200810|E2|Reported Event|Arm II - RO4929097|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
317262|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317243|NCT01200810|E1|Reported Event|Arm I – Placebo|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
317244|NCT01200797|B1|Baseline|Treatment (SJG-136)|Patients receive SJG-136 IV over 20 minutes on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
317245|NCT01200797|P1|Participant Flow|Treatment (SJG-136)|SJG-136 was administered consecutively on days 1 - 3 as a 20-minute intravenous infusion, at a dose of 30 mcg/m2/day. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
317246|NCT01200797|O1|Outcome|Treatment (SJG-136)|Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, consecutively on days 1-3. Treatment courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
317247|NCT01200797|O1|Outcome|Treatment (SJG-136)|Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, consecutively on days 1-3. Treatment courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
317248|NCT01200797|O1|Outcome|Treatment (SJG-136)|Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, consecutively on days 1-3. Treatment courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
317249|NCT01200797|O1|Outcome|Treatment (SJG-136)|Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, consecutively on days 1-3. Treatment courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
317250|NCT01200797|O1|Outcome|Treatment (SJG-136)|Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
317251|NCT01200797|E1|Reported Event|Treatment (SJG-136)|Patients receive SJG-136 IV over 20 minutes on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
317252|NCT01200758|B3|Baseline|Total|Total of all reporting groups
317253|NCT01200758|B2|Baseline|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317254|NCT01200758|B1|Baseline|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317255|NCT01200758|P4|Participant Flow|Stage II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317256|NCT01200758|P3|Participant Flow|Stage II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317257|NCT01200758|P2|Participant Flow|Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV (375 mg/m^2) + 7 cycles of rituximab subcutaneously (SC) (1400 milligrams [mg]; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317258|NCT01200758|P1|Participant Flow|Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab intravenous (IV) infusion (375 milligrams per square meter [mg/m^2]; rituximab induction) in combination with up to 8 cycles of cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP) or cyclophosphamide, vincristine, prednisolone (CVP) chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least partial response (PR) during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317259|NCT01200758|O1|Outcome|All Participants|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP): First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months. Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP): Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317260|NCT01200758|O1|Outcome|All Participants|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP): First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months. Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP): Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317261|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317330|NCT01200589|B1|Baseline|Ofatumumab|Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
317263|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317264|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317265|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317266|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317267|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317268|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317269|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317270|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317271|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317272|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317273|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317274|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317275|NCT01200758|O2|Outcome|Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV (375 mg/m^2) + 7 cycles of rituximab subcutaneously (SC) (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317276|NCT01200758|O1|Outcome|Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317277|NCT01200758|O2|Outcome|Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV (375 mg/m^2) + 7 cycles of rituximab subcutaneously (SC) (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317278|NCT01200758|O1|Outcome|Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317279|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317280|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317847|NCT01198873|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
317281|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317282|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317283|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317284|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317285|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317286|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317287|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317288|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317289|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317290|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317291|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317292|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317293|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317294|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317295|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317296|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317297|NCT01200758|O2|Outcome|Stage II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317298|NCT01200758|O1|Outcome|Stage II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317331|NCT01200589|P2|Participant Flow|Rituximab|Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
317299|NCT01200758|O2|Outcome|Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV (375 mg/m^2) + 7 cycles of rituximab subcutaneously (SC) (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317300|NCT01200758|O1|Outcome|Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317301|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317302|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317303|NCT01200758|O2|Outcome|Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV (375 mg/m^2) + 7 cycles of rituximab subcutaneously (SC) (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317304|NCT01200758|O1|Outcome|Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317305|NCT01200758|O2|Outcome|Stage II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317306|NCT01200758|O1|Outcome|Stage II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317307|NCT01200758|O2|Outcome|Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV (375 mg/m^2) + 7 cycles of rituximab subcutaneously (SC) (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317308|NCT01200758|O1|Outcome|Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317309|NCT01200758|E2|Reported Event|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
317310|NCT01200758|E1|Reported Event|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
317311|NCT01200602|B3|Baseline|Total|Total of all reporting groups
317312|NCT01200602|B2|Baseline|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
317313|NCT01200602|B1|Baseline|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
317314|NCT01200602|P2|Participant Flow|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
317315|NCT01200602|P1|Participant Flow|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
317316|NCT01200602|O2|Outcome|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
317317|NCT01200602|O1|Outcome|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
317318|NCT01200602|O2|Outcome|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
317319|NCT01200602|O1|Outcome|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
317320|NCT01200602|O2|Outcome|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
317321|NCT01200602|O1|Outcome|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
317322|NCT01200602|O2|Outcome|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
317323|NCT01200602|O1|Outcome|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
317324|NCT01200602|O2|Outcome|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
317325|NCT01200602|O1|Outcome|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
317326|NCT01200602|E2|Reported Event|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
317327|NCT01200602|E1|Reported Event|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
317328|NCT01200589|B3|Baseline|Total|Total of all reporting groups
317329|NCT01200589|B2|Baseline|Rituximab|Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
317332|NCT01200589|P1|Participant Flow|Ofatumumab|Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
317333|NCT01200589|O2|Outcome|Rituximab|Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
317334|NCT01200589|O1|Outcome|Ofatumumab|Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
317335|NCT01200589|O2|Outcome|Rituximab|Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
317336|NCT01200589|O1|Outcome|Ofatumumab|Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
317337|NCT01200589|O2|Outcome|Rituximab|Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
317338|NCT01200589|O1|Outcome|Ofatumumab|Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
317339|NCT01200589|O2|Outcome|Rituximab|Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
317340|NCT01200589|O1|Outcome|Ofatumumab|Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
317341|NCT01200589|O2|Outcome|Rituximab|Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
317342|NCT01200589|O1|Outcome|Ofatumumab|Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
317343|NCT01200589|O2|Outcome|Rituximab|Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
317344|NCT01200589|O1|Outcome|Ofatumumab|Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
317345|NCT01200589|O2|Outcome|Rituximab|Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
317346|NCT01200589|O1|Outcome|Ofatumumab|Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
317347|NCT01200589|O2|Outcome|Rituximab|Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
317348|NCT01200589|O1|Outcome|Ofatumumab|Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
317349|NCT01200589|O2|Outcome|Rituximab|Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
317350|NCT01200589|O1|Outcome|Ofatumumab|Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
317351|NCT01200589|O2|Outcome|Rituximab|Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
317352|NCT01200589|O1|Outcome|Ofatumumab|Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
317353|NCT01200589|E2|Reported Event|Rituximab|Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
317354|NCT01200589|E1|Reported Event|Ofatumumab|Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
317355|NCT01200524|B4|Baseline|Total|Total of all reporting groups
317356|NCT01200524|B3|Baseline|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
317357|NCT01200524|B2|Baseline|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
317358|NCT01200524|B1|Baseline|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
317359|NCT01200524|P3|Participant Flow|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
317360|NCT01200524|P2|Participant Flow|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
317361|NCT01200524|P1|Participant Flow|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
317362|NCT01200524|O3|Outcome|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
317363|NCT01200524|O2|Outcome|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
317364|NCT01200524|O1|Outcome|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
317365|NCT01200524|O3|Outcome|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
317366|NCT01200524|O2|Outcome|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
317367|NCT01200524|O1|Outcome|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
317368|NCT01200524|O3|Outcome|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
317369|NCT01200524|O2|Outcome|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
317370|NCT01200524|O1|Outcome|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
317371|NCT01200524|O3|Outcome|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
317372|NCT01200524|O2|Outcome|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
317373|NCT01200524|O1|Outcome|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
317374|NCT01200524|O3|Outcome|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
317375|NCT01200524|O2|Outcome|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
317376|NCT01200524|O1|Outcome|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
317377|NCT01200524|E3|Reported Event|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
317380|NCT01200511|B1|Baseline|ReSTOR +3.0 Toric|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
317381|NCT01200511|P1|Participant Flow|ReSTOR +3.0 Toric|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
317382|NCT01200511|O2|Outcome|ReSTOR +3.0 Toric/With|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids if needed
317383|NCT01200511|O1|Outcome|ReSTOR +3.0 Toric/Without|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation, without corrective aids
317384|NCT01200511|O1|Outcome|ReSTOR +3.0 Toric|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
317385|NCT01200511|O1|Outcome|ReSTOR +3.0 Toric|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
317386|NCT01200511|O1|Outcome|ReSTOR +3.0 Toric|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
317387|NCT01200511|E1|Reported Event|ReSTOR +3.0 Toric|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
317388|NCT01200498|B1|Baseline|SB939|SB939 starting dose 60 mg by mouth every other day, 3 times weekly for 3 weeks.
317389|NCT01200498|P1|Participant Flow|SB939|SB939 starting dose 60 mg by mouth every other day, three times weekly for 3 weeks.
317390|NCT01200498|O1|Outcome|SB939|SB939 starting dose 60 mg by mouth every other day, three times weekly for 3 weeks.
317391|NCT01200498|E1|Reported Event|SB939|SB939 starting dose 60 mg by mouth every other day, 3 times weekly for 3 weeks.
317392|NCT01200433|B3|Baseline|Total|Total of all reporting groups
317393|NCT01200433|B2|Baseline|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
317394|NCT01200433|B1|Baseline|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
317395|NCT01200433|P2|Participant Flow|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
317396|NCT01200433|P1|Participant Flow|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
317397|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
317398|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
317399|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
317400|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
317401|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
317402|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
317403|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
317404|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
317405|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
317406|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
317407|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
317408|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
317409|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
317410|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
317411|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
317412|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
317413|NCT01200433|E2|Reported Event|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
317414|NCT01200433|E1|Reported Event|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
317415|NCT01200368|B4|Baseline|Total|Total of all reporting groups
317416|NCT01200368|B3|Baseline|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
317417|NCT01200368|B2|Baseline|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
317418|NCT01200368|B1|Baseline|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
317419|NCT01200368|P3|Participant Flow|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
317420|NCT01200368|P2|Participant Flow|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
317421|NCT01200368|P1|Participant Flow|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
317422|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
317423|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
317424|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
317425|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
317426|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
317427|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
317428|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
317429|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
317430|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
317431|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
317432|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
317433|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
317434|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
317435|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
317436|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
317437|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
317438|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
317439|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
317440|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
317441|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
317506|NCT01200290|B1|Baseline|LY2127399|LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
317442|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
317443|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
317444|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
317445|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
317446|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
317447|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
317448|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
317449|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
317450|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
317451|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
317452|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
317453|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
317454|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
317455|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
317578|NCT01199965|B1|Baseline|Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result.
317456|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
317457|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
317458|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
317459|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
317460|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
317461|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
317462|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
317463|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
317464|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
317465|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
317466|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
317467|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
317468|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
317469|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
317505|NCT01200342|E1|Reported Event|Genasense + Paclitaxel + Carboplatin|Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
317470|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
317471|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
317472|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
317473|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
317474|NCT01200368|E10|Reported Event|DTaP (Catch-up 7vPnC) - After the Toddler Dose|Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed after the CU Dose 3 to 28 to 42 days post-CU Dose 3.
317475|NCT01200368|E9|Reported Event|DTaP (Catch-up 7vPnC) - Toddler Dose|Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed from toddler dose through the CU Dose 3.
317476|NCT01200368|E8|Reported Event|7vPnC + DTaP - Toddler Dose|Participants who received a single 0.5 mL dose of 7vPnC subcutaneously (toddler dose) along with 0.5 mL dose of DTaP subcutaneously, assessed from the toddler dose through the blood draw 28 to 42 days post-toddler dose.
317477|NCT01200368|E7|Reported Event|13vPnC + DTaP - Toddler Dose|Participants who received a single 0.5 mL dose of 13vPnC subcutaneously (toddler dose) along with 0.5 mL dose of DTaP subcutaneously, assessed from the toddler dose through the blood draw 28 to 42 days post-toddler dose.
317478|NCT01200368|E6|Reported Event|DTaP (Catch-up 7vPnC) - After the Infant Series|Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed after CU Dose 1 to the toddler dose.
317479|NCT01200368|E5|Reported Event|7vPnC + DTaP - After the Infant Series|Participants who received 3 single 0.5 mL doses of 13vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed after the infant series blood draw to the toddler dose.
317480|NCT01200368|E4|Reported Event|13vPnC + DTaP - After the Infant Series|Participants who received 3 single 0.5 mL doses of 13vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed after the infant series blood draw to the toddler dose.
317481|NCT01200368|E3|Reported Event|DTaP (Catch-up 7vPnC) - Infant Series|Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed from Infant Dose 1 through the CU Dose 1.
317482|NCT01200368|E2|Reported Event|7vPnC + DTaP - Infant Series|Participants who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed from Infant Dose 1 through the blood draw 28 to 42 days post-infant series.
317483|NCT01200368|E1|Reported Event|13vPnC + DTaP - Infant Series|Participants who received 3 single 0.5 mL doses of 13vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed from Infant Dose 1 through the blood draw 28 to 42 days post-infant series.
317484|NCT01200355|B3|Baseline|Total|Total of all reporting groups
317485|NCT01200355|B2|Baseline|Posaconazole|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).~posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
317486|NCT01200355|B1|Baseline|Micafungin|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).~micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
317487|NCT01200355|P2|Participant Flow|Posaconazole|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).~posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
317488|NCT01200355|P1|Participant Flow|Micafungin|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).~micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
317848|NCT01198873|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
317489|NCT01200355|O2|Outcome|Posaconazole|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).~posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
317490|NCT01200355|O1|Outcome|Micafungin|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).~micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
317491|NCT01200355|O2|Outcome|Posaconazole|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).~posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
317492|NCT01200355|O1|Outcome|Micafungin|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).~micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
317493|NCT01200355|O2|Outcome|Posaconazole|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).~posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
317494|NCT01200355|O1|Outcome|Micafungin|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).~micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
317495|NCT01200355|O2|Outcome|Posaconazole|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).~posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
317496|NCT01200355|O1|Outcome|Micafungin|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).~micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
317497|NCT01200355|O2|Outcome|Posaconazole|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).~posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
317498|NCT01200355|O1|Outcome|Micafungin|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).~micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
317499|NCT01200355|E2|Reported Event|Posaconazole|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).~posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
317500|NCT01200355|E1|Reported Event|Micafungin|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).~micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
317501|NCT01200342|B1|Baseline|Genasense + Paclitaxel + Carboplatin|Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
317502|NCT01200342|P1|Participant Flow|Genasense + Paclitaxel + Carboplatin|Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
317503|NCT01200342|O1|Outcome|Genasense + Paclitaxel + Carboplatin|Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
317504|NCT01200342|O1|Outcome|Genasense + Paclitaxel + Carboplatin|Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
317507|NCT01200290|P1|Participant Flow|LY2127399|LY2127399 was administered as a loading dose of 240-milligram (mg) subcutaneous (SC) injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
317508|NCT01200290|O1|Outcome|LY2127399|LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
317509|NCT01200290|O1|Outcome|LY2127399|LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
317510|NCT01200290|O1|Outcome|LY2127399|LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
317511|NCT01200290|O1|Outcome|LY2127399|LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
317512|NCT01200290|O1|Outcome|LY2127399|LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
317513|NCT01200290|O1|Outcome|LY2127399|LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
317514|NCT01200290|O1|Outcome|LY2127399|LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
317515|NCT01200290|O1|Outcome|LY2127399|LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
317516|NCT01200290|E1|Reported Event|LY2127399|LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
317517|NCT01200160|B1|Baseline|Lipid Abnormalities|
317518|NCT01200160|P1|Participant Flow|Lipid Abnormalities|"No comparison groups for this observational study. Patients receive only one type of formulation, then drug exposure was the same for all patients.~This study was conducted in a prospective, single-arm, multi-center format. As this study was observational in nature, the follow-up of subject’s was not prescriptive in nature and was according to the judgment of the investigator, within the period of observation set forth in the protocol.~Typically, Niaspan is titrated in the following manner: After Week 8, titrate to patient response and tolerance. If response to 1000 mg daily is inadequate increase dose to 1500 mg daily; may subsequently increase dose to 2000 mg daily. Ideally, Niaspan should not be increased more than 500 mg in a 4-week period and daily doses above 2000 mg are not recommended. It is expected that women may respond at lower doses than men. However, consult with the approved label for titration recommendation in the particular country."
317519|NCT01200160|O1|Outcome|HDL-Cholesterol|
317520|NCT01200160|E1|Reported Event|Lipid Abnormalities|Those with the condition and exposed to the study drug
317521|NCT01200069|B3|Baseline|Total|Total of all reporting groups
317522|NCT01200069|B2|Baseline|Ibuprofen|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3"
317523|NCT01200069|B1|Baseline|Sugar Water|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 1,2 and 3~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3"
317524|NCT01200069|P2|Participant Flow|Ibuprofen|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3"
317525|NCT01200069|P1|Participant Flow|Sugar Water|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 1,2 and 3~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3"
317526|NCT01200069|O8|Outcome|Ibuprofen 48 Hours After Treatment 3|Subject reported headache 48 hours after completion of treatment #3
317527|NCT01200069|O7|Outcome|Sugar Water 48 Hours After Treatment 3|Subject reported headache 48 hours after completion of treatment #3
317528|NCT01200069|O6|Outcome|Ibuprofen 24 Hours After Treatment #3|Subject reported headache 24 hours after completion of treatment #3
317529|NCT01200069|O5|Outcome|Sugar Water 24 Hours After Treatment #3|Subject reported headache 24 hours after completion of treatment #3
317530|NCT01200069|O4|Outcome|Ibuprofen 6 Hours After Treatment #3|Subject reported headache 6 hours after completion of treatment #3
317531|NCT01200069|O3|Outcome|Sugar Water 6 Hours After Procedure #3|Subject reported headache 6 hours after completion of treatment #3
317532|NCT01200069|O2|Outcome|Ibuprofen One Hour After Treatment #3|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 3 one hour after treatment~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2"
317533|NCT01200069|O1|Outcome|Sugar Water-one Hour After Treatment 3|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 3~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatment day 2"
317534|NCT01200069|O8|Outcome|Ibuprofen 48 Hours After Treatment #2|Subject reported headache 48 hours after completion of treatment #2
317535|NCT01200069|O7|Outcome|Sugar Water 48 Hours After Treatment #2|Subject reported headache 48 hours after completion of treatment #2
317536|NCT01200069|O6|Outcome|Ibuprofen 24 Hours After Treatment #2|Subject reported headache 24 hours after completion of treatment #2
317537|NCT01200069|O5|Outcome|Sugar Water 24 Hours After Treatment #2|Subject reported headache 24 hours after completion of treatment #2
317538|NCT01200069|O4|Outcome|Ibuprofen 6 Hours After Treatment #2|Subject reported headache 6 hours after completion of treatment #2
317539|NCT01200069|O3|Outcome|Sugar Water 6 Hours After Procedure #2|Subject reported headache 6 hours after completion of treatment #2
317579|NCT01199965|P2|Participant Flow|Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening.
317540|NCT01200069|O2|Outcome|Ibuprofen One Hour After Treatment #2|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments #2 one hour after treatment~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2"
317541|NCT01200069|O1|Outcome|Sugar Water-one Hour After Treatment 2|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 2~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatment day 2"
317542|NCT01200069|O8|Outcome|Pain Score Ibuprofen 48 Hours After Treatment 1|Subjects reported headache 48 hours after completion of treatment #1
317543|NCT01200069|O7|Outcome|Pain Score Sugar Water 48 Hours After Treatment 1|Subjects reported headache 48 hours after completion of treatment #1
317544|NCT01200069|O6|Outcome|Pain Score Ibuprofen 24 Hours After Treatment #1|Subjects reported headache 24 hours after completion of treatment #1
317545|NCT01200069|O5|Outcome|Pain Score Sugar Water 24 Hours After Treatment #1|Subject reported headache 24 hours after completion of treatment #1
317546|NCT01200069|O4|Outcome|Pain Score Ibuprofen 6 Hours After Treatment #1|Subject reported headache 6 hours after completion of treatment #1
317547|NCT01200069|O3|Outcome|Pain Score After Sugar Water 6 Hours After Treatment #1|Subject reported headache 6 hours after completion of treatment #1
317548|NCT01200069|O2|Outcome|Pain Score Ibuprofen One Hour After Treatment #1|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1 one hour after treatment~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2"
317549|NCT01200069|O1|Outcome|Pain Score Sugar Water-one Hour After Treatment 1|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 1~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatment day 1"
317550|NCT01200069|O8|Outcome|Ibuprofen 48 Hours After Treatment 3|Subject reported myalgia 48 hours after completion of treatment #3
317551|NCT01200069|O7|Outcome|Sugar Water 48 Hours After Treatment 3|Subject reported myalgia 48 hours after completion of treatment #3
317552|NCT01200069|O6|Outcome|Ibuprofen 24 Hours After Treatment #3|Subject reported myalgia 24 hours after completion of treatment #3
317553|NCT01200069|O5|Outcome|Sugar Water 24 Hours After Treatment #3|Subject reported myalgia 24 hours after completion of treatment #3
317554|NCT01200069|O4|Outcome|Ibuprofen 6 Hours After Treatment #3|Subject reported myalgia 6 hours after completion of treatment #3
317555|NCT01200069|O3|Outcome|Sugar Water 6 Hours After Procedure #3|Subject reported myalgia 6 hours after completion of treatment #3
317556|NCT01200069|O2|Outcome|Ibuprofen One Hour After Treatment #3|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 3 one hour after treatment~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2"
317557|NCT01200069|O1|Outcome|Sugar Water-one Hour After Treatment 3|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 3~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatment day 2"
317558|NCT01200069|O8|Outcome|Ibuprofen 48 Hours After Treatment 2|Subject reported myalgia 48 hours after completion of treatment #2
317559|NCT01200069|O7|Outcome|Sugar Water 48 Hours After Treatment 2|Subject reported myalgia 48 hours after completion of treatment #2
317560|NCT01200069|O6|Outcome|Ibuprofen 24 Hours After Treatment #2|Subject reported myalgia 24 hours after completion of treatment #2
317561|NCT01200069|O5|Outcome|Sugar Water 24 Hours After Treatment #2|Subject reported myalgia 24 hours after completion of treatment #2
317562|NCT01200069|O4|Outcome|Ibuprofen 6 Hours After Treatment #2|Subject reported myalgia 6 hours after completion of treatment #2
317563|NCT01200069|O3|Outcome|Sugar Water 6 Hours After Procedure #2|Subject reported myalgia 6 hours after completion of treatment #2
317564|NCT01200069|O2|Outcome|Ibuprofen One Hour After Treatment #2|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 2 one hour after treatment~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2"
317565|NCT01200069|O1|Outcome|Sugar Water-one Hour After Treatment 2|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 2~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatment day 2"
317566|NCT01200069|O8|Outcome|Ibuprofen 48 Hours After Treatment 1|subject reported myalgia 48 hours after treatment day 1
317567|NCT01200069|O7|Outcome|Sugar Water 48 Hours After Procedure 1|subject reported myalgia 48 hours after procedure 1
317568|NCT01200069|O6|Outcome|Ibuprofen 24 Hours After Treatment 1|subject reported myalgia 24 hours after procedure 1
317569|NCT01200069|O5|Outcome|Sugar Water 24 Hours After Treatment #1|subject reported myalgia 24 hours after completion of procedure 1
317570|NCT01200069|O4|Outcome|Ibuprofen 6 Hours After Treatment #1|subject reported myalgia 6 hours after treatment 1
317571|NCT01200069|O3|Outcome|Sugar Water 6 Hours After Procedure #1|Subject reported myalgia 6 hours after completion of treatment # 1,
317572|NCT01200069|O2|Outcome|Ibuprofen One Hour After Treatment #1|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3~subject report of myalgia one hour after completion of procedure number 1"
317573|NCT01200069|O1|Outcome|Sugar Water-one Hour After Treatment #1|500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatment 1, at one hour following procedure
317574|NCT01200069|E2|Reported Event|Ibuprofen|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3"
317575|NCT01200069|E1|Reported Event|Sugar Water|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 1,2 and 3~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3"
317576|NCT01199965|B3|Baseline|Total|Total of all reporting groups
317577|NCT01199965|B2|Baseline|Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening.
317581|NCT01199965|O4|Outcome|IV DHE 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving IV DHE at Visit 2 or 3.
317582|NCT01199965|O3|Outcome|IV DHE 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving IV DHE at Visit 2 or 3.
317583|NCT01199965|O2|Outcome|MAP0004 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving MAP0004 at Visit 2 or 3.
317584|NCT01199965|O1|Outcome|MAP0004 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving MAP0004 at Visit 2 or 3.
317585|NCT01199965|O4|Outcome|IV DHE 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving IV DHE at either Visit 2 or 3.
317586|NCT01199965|O3|Outcome|IV DHE 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving IV DHE at either Visit 2 or 3.
317587|NCT01199965|O2|Outcome|MAP0004 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving MAP0004 at either Visit 2 or 3.
317588|NCT01199965|O1|Outcome|MAP0004 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving MAP0004 at either Visit 2 or 3.
317589|NCT01199965|E4|Reported Event|IV DHE 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving IV DHE at either Visit 2 or 3.
317590|NCT01199965|E3|Reported Event|IV DHE 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving IV DHE at either Visit 2 or 3.
317591|NCT01199965|E2|Reported Event|MAP0004 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving MAP0004 at either Visit 2 or 3.
317592|NCT01199965|E1|Reported Event|MAP0004 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving MAP0004 at either Visit 2 or 3.
317593|NCT01199939|B1|Baseline|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
317594|NCT01199939|P1|Participant Flow|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
317595|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
317596|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
317597|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
317598|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
317599|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
317600|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
317601|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
317602|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
317603|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
317604|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
317605|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
317606|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
317607|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
317608|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
317609|NCT01199939|E1|Reported Event|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
317610|NCT01199926|B3|Baseline|Total|Total of all reporting groups
317611|NCT01199926|B2|Baseline|Placebo|Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
317612|NCT01199926|B1|Baseline|Vitamin D|Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
317613|NCT01199926|P2|Participant Flow|Placebo|Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
317614|NCT01199926|P1|Participant Flow|Vitamin D|Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
317615|NCT01199926|O2|Outcome|Placebo|Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
317616|NCT01199926|O1|Outcome|Vitamin D|Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
317617|NCT01199926|O2|Outcome|Placebo|Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
317618|NCT01199926|O1|Outcome|Vitamin D|Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
317619|NCT01199926|O2|Outcome|Placebo|Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
317620|NCT01199926|O1|Outcome|Vitamin D|Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
317621|NCT01199926|E2|Reported Event|Placebo|Were asked to consume a placebo pill (microcrystalline cellulose) each day for 3 months while performing a resistance training intervention.
317622|NCT01199926|E1|Reported Event|Vitamin D|Were asked to consume 4000 IU of vitamin D/day for 3 months while performing a resistance training intervention.
317623|NCT01199861|B3|Baseline|Total|Total of all reporting groups
317624|NCT01199861|B2|Baseline|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
317625|NCT01199861|B1|Baseline|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
317626|NCT01199861|P2|Participant Flow|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
317627|NCT01199861|P1|Participant Flow|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
317628|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
317629|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
317630|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
317631|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
317632|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
317633|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
317634|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
317635|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
317636|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
317637|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
317638|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
317639|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
317640|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
317641|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
317642|NCT01199861|E2|Reported Event|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
317643|NCT01199861|E1|Reported Event|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
317644|NCT01199822|B4|Baseline|Total|Total of all reporting groups
317645|NCT01199822|B3|Baseline|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
317646|NCT01199822|B2|Baseline|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
317647|NCT01199822|B1|Baseline|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
317648|NCT01199822|P3|Participant Flow|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
317649|NCT01199822|P2|Participant Flow|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
317650|NCT01199822|P1|Participant Flow|10 mg/kg Olaratumab (IMC-3G3)|10 milligrams/kilogram (mg/kg) olaratumab intravenously (IV) administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of progressive disease (PD), or until other withdrawal criteria were met.
317651|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
317652|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
317653|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
317654|NCT01199822|O1|Outcome|Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met. 20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met. 15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
317655|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
317656|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle) during Cycles 1 and 2.
317657|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
317658|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
317659|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle) during Cycles 1 and 2.
317660|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
317661|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
317662|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle) during Cycles 1 and 2.
317663|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
317664|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
317665|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle) during Cycles 1 and 2.
317666|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
317667|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
317668|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle) during Cycles 1 and 2.
317669|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
317670|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycle 1.
317671|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle) during Cycle 1.
317672|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycle 1.
317673|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
317674|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
317675|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
317676|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
317677|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
317678|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
317679|NCT01199822|E3|Reported Event|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
317680|NCT01199822|E2|Reported Event|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
317681|NCT01199822|E1|Reported Event|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
317682|NCT01199744|B1|Baseline|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
317683|NCT01199744|P1|Participant Flow|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
317684|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
317685|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
317686|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
317687|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
317688|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
317689|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
317690|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
317691|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
317692|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
317693|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
317694|NCT01199744|E1|Reported Event|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
317695|NCT01199731|B4|Baseline|Total|Total of all reporting groups
317696|NCT01199731|B3|Baseline|ETV 200 mg|Participants received ETV 2 x 100 mg tablet once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317697|NCT01199731|B2|Baseline|GSK2248761 200 mg|Participants received GSK2248761 2 x 100 mg capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317698|NCT01199731|B1|Baseline|GSK2248761 100 mg|Participants received GSK2248761 1 x 100 mg capsule once daily orally, 1 x Placebo to match GSK2248761 capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317699|NCT01199731|P3|Participant Flow|Etravirine (ETV)|Participants received ETV 2 x 100 mg tablet once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317700|NCT01199731|P2|Participant Flow|GSK2248761 200 mg|Participants received GSK2248761 2 x 100 mg capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317701|NCT01199731|P1|Participant Flow|GSK2248761 100 Milligram (mg)|Participants received GSK2248761 1 x 100 mg capsule once daily orally, 1 x Placebo to match GSK2248761 capsule once daily orally, Darunavir (DRV) 1 x 600 mg tablet twice daily with food orally, Ritonavir (RTV) 1 x 100 mg tablet twice daily orally and Raltegravir(RAL) 1 x 400 mg tablet twice daily orally up to 48 weeks.
317702|NCT01199731|O3|Outcome|ETV 200 mg|Participants received ETV 2 x 100 mg tablet once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317703|NCT01199731|O2|Outcome|GSK2248761 200 mg|Participants received GSK2248761 2 x 100 mg capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317704|NCT01199731|O1|Outcome|GSK2248761 100 mg|Participants received GSK2248761 1 x 100 mg capsule once daily orally, 1 x Placebo to match GSK2248761 capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317705|NCT01199731|O3|Outcome|ETV 200 mg|Participants received ETV 2 x 100 mg tablet once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317706|NCT01199731|O2|Outcome|GSK2248761 200 mg|Participants received GSK2248761 2 x 100 mg capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317707|NCT01199731|O1|Outcome|GSK2248761 100 mg|Participants received GSK2248761 1 x 100 mg capsule once daily orally, 1 x Placebo to match GSK2248761 capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317708|NCT01199731|O2|Outcome|GSK2248761 200 mg|Participants received GSK2248761 2 x 100 mg capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317709|NCT01199731|O1|Outcome|GSK2248761 100 mg|Participants received GSK2248761 1 x 100 mg capsule once daily orally, 1 x Placebo to match GSK2248761 capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317710|NCT01199731|O3|Outcome|ETV 200 mg|Participants received ETV 2 x 100 mg tablet once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317711|NCT01199731|O2|Outcome|GSK2248761 200 mg|Participants received GSK2248761 2 x 100 mg capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317712|NCT01199731|O1|Outcome|GSK2248761 100 mg|Participants received GSK2248761 1 x 100 mg capsule once daily orally, 1 x Placebo to match GSK2248761 capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317713|NCT01199731|O2|Outcome|GSK2248761 200 mg|Participants received GSK2248761 2 x 100 mg capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317714|NCT01199731|O1|Outcome|GSK2248761 100 mg|Participants received GSK2248761 1 x 100 mg capsule once daily orally, 1 x Placebo to match GSK2248761 capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317715|NCT01199731|O3|Outcome|ETV 200 mg|Participants received ETV 2 x 100 mg tablet once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317716|NCT01199731|O2|Outcome|GSK2248761 200 mg|Participants received GSK2248761 2 x 100 mg capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317717|NCT01199731|O1|Outcome|GSK2248761 100 mg|Participants received GSK2248761 1 x 100 mg capsule once daily orally, 1 x Placebo to match GSK2248761 capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317718|NCT01199731|O2|Outcome|GSK2248761 200 mg|Participants received GSK2248761 2 x 100 mg capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317719|NCT01199731|O1|Outcome|GSK2248761 100 mg|Participants received GSK2248761 1 x 100 mg capsule once daily orally, 1 x Placebo to match GSK2248761 capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317720|NCT01199731|O3|Outcome|ETV 200 mg|Participants received ETV 2 x 100 mg tablet once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317721|NCT01199731|O2|Outcome|GSK2248761 200 mg|Participants received GSK2248761 2 x 100 mg capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317722|NCT01199731|O1|Outcome|GSK2248761 100 mg|Participants received GSK2248761 1 x 100 mg capsule once daily orally, 1 x Placebo to match GSK2248761 capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317723|NCT01199731|O3|Outcome|ETV 200 mg|Participants received ETV 2 x 100 mg tablet once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317724|NCT01199731|O2|Outcome|GSK2248761 200 mg|Participants received GSK2248761 2 x 100 mg capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317725|NCT01199731|O1|Outcome|GSK2248761 100 mg|Participants received GSK2248761 1 x 100 mg capsule once daily orally, 1 x Placebo to match GSK2248761 capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317726|NCT01199731|O3|Outcome|ETV 200 mg|Participants received ETV 2 x 100 mg tablet once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317727|NCT01199731|O2|Outcome|GSK2248761 200 mg|Participants received GSK2248761 2 x 100 mg capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317728|NCT01199731|O1|Outcome|GSK2248761 100 mg|Participants received GSK2248761 1 x 100 mg capsule once daily orally, 1 x Placebo to match GSK2248761 capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317729|NCT01199731|O3|Outcome|ETV 200 mg|Participants received ETV 2 x 100 mg tablet once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317730|NCT01199731|O2|Outcome|GSK2248761 200 mg|Participants received GSK2248761 2 x 100 mg capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317731|NCT01199731|O1|Outcome|GSK2248761 100 mg|Participants received GSK2248761 1 x 100 mg capsule once daily orally, 1 x Placebo to match GSK2248761 capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317732|NCT01199731|O3|Outcome|ETV 200 mg|Participants received ETV 2 x 100 mg tablet once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317733|NCT01199731|O2|Outcome|GSK2248761 200 mg|Participants received GSK2248761 2 x 100 mg capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317734|NCT01199731|O1|Outcome|GSK2248761 100 mg|Participants received GSK2248761 1 x 100 mg capsule once daily orally, 1 x Placebo to match GSK2248761 capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317735|NCT01199731|E3|Reported Event|ETV 200 mg|Participants received ETV 2 x 100 mg tablet once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317736|NCT01199731|E2|Reported Event|GSK2248761 200 mg|Participants received GSK2248761 2 x 100 mg capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317737|NCT01199731|E1|Reported Event|GSK2248761 100 mg|Participants received GSK2248761 1 x 100 mg capsule once daily orally, 1 x Placebo to match GSK2248761 capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
317738|NCT01199705|B1|Baseline|IgPro20|Immune Globulin Subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous use. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.
317739|NCT01199705|P1|Participant Flow|IgPro20|Immune Globulin Subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous use. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.
317740|NCT01199705|O2|Outcome|SCIG Treatment|IgPro20 was administered subcutaneously with the first SC IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period followed by a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG IgG treatment.
317741|NCT01199705|O1|Outcome|IVIG Treatment|Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
317742|NCT01199705|O2|Outcome|SCIG Treatment|IgPro20 was administered subcutaneously with the first SC IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period followed by a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG IgG treatment.
317743|NCT01199705|O1|Outcome|IVIG Treatment|Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
317744|NCT01199705|O2|Outcome|IgPro20 - Full Analysis Set (FAS)|The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
317745|NCT01199705|O1|Outcome|IgPro20 - Per Protocol Set (PPS)|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
317746|NCT01199705|O2|Outcome|IgPro20 - Full Analysis Set (FAS)|The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
317747|NCT01199705|O1|Outcome|IgPro20 - Per Protocol Set (PPS)|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
317748|NCT01199705|O3|Outcome|SCIG IgPro20 Treatment (Efficacy)|Weekly SC IgPro20 infusions for a 12-week efficacy period.
317749|NCT01199705|O2|Outcome|SCIG IgPro20 Treatment (Wash-in/Wash-out)|Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period.
317750|NCT01199705|O1|Outcome|IVIG Treatment|Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
317751|NCT01199705|O2|Outcome|IgPro20 - Full Analysis Set (FAS)|The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
317752|NCT01199705|O1|Outcome|IgPro20 - Per Protocol Set (PPS)|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
317753|NCT01199705|O3|Outcome|SCIG IgPro20 Treatment (Efficacy)|Weekly SC IgPro20 infusions for a 12-week efficacy period.
317754|NCT01199705|O2|Outcome|SCIG IgPro20 Treatment (Wash-in/Wash-out)|Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period.
317755|NCT01199705|O1|Outcome|IVIG Treatment|Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
317756|NCT01199705|O3|Outcome|SCIG Treatment (Efficacy)|Weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
317757|NCT01199705|O2|Outcome|SCIG Treatment (Wash-in/Wash-out)|Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
317758|NCT01199705|O1|Outcome|IVIG Treatment|Subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
317759|NCT01199705|O3|Outcome|SCIG Treatment (Efficacy)|Weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
317760|NCT01199705|O2|Outcome|SCIG Treatment (Wash-in/Wash-out)|Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
317761|NCT01199705|O1|Outcome|IVIG Treatment|Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
317762|NCT01199705|O2|Outcome|IgPro20 - Full Analysis Set (FAS)|The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
317763|NCT01199705|O1|Outcome|IgPro20 - Per Protocol Set (PPS)|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
317764|NCT01199705|O2|Outcome|IgPro20 - Full Analysis Set (FAS)|The FAS comprised all subjects treated with IgPro20 during the SCIG efficacy period (weeks 13 to 24) who had the disease under study.
317765|NCT01199705|O1|Outcome|IgPro20 - Per Protocol Set (PPS)|The PPS data set comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) uniformly repeated immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
317766|NCT01199705|E2|Reported Event|SCIG Treatment|IgPro20 was administered subcutaneously with the first SC IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period followed by a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG IgG treatment.
317767|NCT01199705|E1|Reported Event|IVIG Treatment|Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks; before being switched to SCIG treatment with IgPro20).
317768|NCT01199601|B3|Baseline|Total|Total of all reporting groups
317769|NCT01199601|B2|Baseline|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider (intervention group).~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
317770|NCT01199601|B1|Baseline|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from existing hospital providers (control group) .~Intrapartum, postpartum counseling : Intrapartum testing and routine counseling."
317771|NCT01199601|P2|Participant Flow|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider (intervention)~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
317772|NCT01199601|P1|Participant Flow|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from existing hospital providers of same professional cadre as intervention group.~Intrapartum, postpartum counseling : Intrapartum testing and routine counseling package provided by study."
317773|NCT01199601|O2|Outcome|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
317774|NCT01199601|O1|Outcome|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from re-trained hospital providers of same professional cadre as control group.~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling package provided by study."
317775|NCT01199601|O2|Outcome|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
317776|NCT01199601|O1|Outcome|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from re-trained hospital providers of same professional cadre as control group.~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling package provided by study."
317777|NCT01199601|O2|Outcome|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
317778|NCT01199601|O1|Outcome|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from re-trained hospital providers of same professional cadre as control group.~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling package provided by study."
317779|NCT01199601|E2|Reported Event|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
317780|NCT01199601|E1|Reported Event|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from re-trained hospital providers of same professional cadre as control group.~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling package provided by study."
317781|NCT01199471|B1|Baseline|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
317782|NCT01199471|P1|Participant Flow|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
317783|NCT01199471|O1|Outcome|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
317784|NCT01199471|O1|Outcome|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
317785|NCT01199471|O1|Outcome|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
317786|NCT01199471|O1|Outcome|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
317787|NCT01199471|O1|Outcome|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
317788|NCT01199471|O1|Outcome|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 through 3, who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA).
317849|NCT01198873|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
317850|NCT01198873|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
317851|NCT01198873|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
317789|NCT01199471|E1|Reported Event|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
317790|NCT01199237|B3|Baseline|Total|Total of all reporting groups
317791|NCT01199237|B2|Baseline|Desflurane|Patients received Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
317792|NCT01199237|B1|Baseline|Sevoflurane|Patients received sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
317793|NCT01199237|P2|Participant Flow|Desflurane|Patients received Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
317794|NCT01199237|P1|Participant Flow|Sevoflurane|Patients received sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
317795|NCT01199237|O2|Outcome|Desflurane|Patients received Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
317796|NCT01199237|O1|Outcome|Sevoflurane|Patients received sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
317797|NCT01199237|O2|Outcome|Desflurane|"Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
317798|NCT01199237|O1|Outcome|Sevoflurane|"Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
317799|NCT01199237|O2|Outcome|Desflurane|"Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
317800|NCT01199237|O1|Outcome|Sevoflurane|"Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
317801|NCT01199237|O2|Outcome|Desflurane|"Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
317802|NCT01199237|O1|Outcome|Sevoflurane|"Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
317803|NCT01199237|O2|Outcome|Desflurane|"Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
317804|NCT01199237|O1|Outcome|Sevoflurane|"Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
317805|NCT01199237|E2|Reported Event|Desflurane|"Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
317806|NCT01199237|E1|Reported Event|Sevoflurane|"Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
317807|NCT01199146|B1|Baseline|Abiraterone Acetate|Abiraterone acetate 1000 mg by mouth per day
317808|NCT01199146|P1|Participant Flow|Abiraterone Acetate|Abiraterone acetate 1000 mg by mouth per day
317809|NCT01199146|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 mg by mouth per day
317810|NCT01199146|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 mg by mouth per day
317811|NCT01199146|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 mg by mouth per day
317812|NCT01199146|E1|Reported Event|Abiraterone Acetate|Abiraterone acetate 1000 mg by mouth per day
317813|NCT01199042|B1|Baseline|Diagnostic, Then CPAP, Then BiPAP autoSV Advanced|Diagnostic, then CPAP, then BiPAP autoSV Advanced (within-subjects design)
317814|NCT01199042|P1|Participant Flow|Diagnostic, Continuous Positive Airway Pressure (CPAP), ASV|All participants first underwent a full night, attended diagnostic PSG. Eligible participants then had an attended full night Continuous Positive Airway Pressure (CPAP) manual titration followed by full night, attended, but automated titration with the BiPAP automatic Servo Ventilation.(AutoSV) Advanced™ (Philips Respironics, Murrysville, PA), device.
317815|NCT01199042|O1|Outcome|Diagnostic, Continuous Positive Airway Pressure (CPAP), ASV|All participants first underwent a full night, attended diagnostic PSG. Eligible participants then had an attended full night Continuous Positive Airway Pressure (CPAP) manual titration followed by full night, attended, but automated titration with the BiPAP automatic Servo Ventilation.(AutoSV) Advanced™ (Philips Respironics, Murrysville, PA), device.
317816|NCT01199042|O1|Outcome|BiPAP autoSV Advanced Device|"Positive airway pressure device~BiPAP autoSV Advanced: The sleep apnea device will be set-up in automatic mode with the settings wide open for the entire night."
317817|NCT01199042|O1|Outcome|BiPAP autoSV Advanced Device|Over the 90-day home treatment period, the Auto-Servo Ventilation (ASV) device consistently treated obstructive and central Sleep Disordered Breathing (SDB) events.
317818|NCT01199042|O3|Outcome|BiPAP autoSV Apnea-Hypopnea Index|The BiPAP autoSV machine was used to determine the Apnea-Hypopnea Index
317819|NCT01199042|O2|Outcome|Continuous Positive Airway Pressure Apnea-Hypopnea Index|The CPAP machine was used to determine the Apnea-Hypopnea Index.
317820|NCT01199042|O1|Outcome|Diagnostic Apnea-Hypopnea Index|Participants had Diagnostic PSG where the Apnea-Hypopnea Index was measured
317821|NCT01199042|E1|Reported Event|Diagnostic, Then CPAP, Then BiPAP autoSV Advanced|Participants had a diagnostic PSG, then CPAP and BiPAP autoSV. Participants then went home and used the autoSV for 90 days.
317852|NCT01198873|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
317853|NCT01198873|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
317822|NCT01199016|B1|Baseline|Prevnar 13|Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).
317823|NCT01199016|P1|Participant Flow|Prevnar 13|Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).
317824|NCT01199016|O1|Outcome|Prevnar 13|Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).
317825|NCT01199016|O1|Outcome|Prevnar 13|Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).
317826|NCT01199016|O1|Outcome|Prevnar 13|Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).
317827|NCT01199016|O1|Outcome|Prevnar 13|Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).
317828|NCT01199016|E1|Reported Event|Prevnar 13|Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).
317829|NCT01198977|B3|Baseline|Total|Total of all reporting groups
317830|NCT01198977|B2|Baseline|Education Counseling|"Exercise information and instructional video~Informational video: Mailed video of exercise programs"
317831|NCT01198977|B1|Baseline|Telephone Counseling|"Telephone based counseling and instructional video~Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
317832|NCT01198977|P2|Participant Flow|Education Counseling|"Exercise information and instructional video~Informational video: Mailed video of exercise programs"
317833|NCT01198977|P1|Participant Flow|Telephone Counseling|"Telephone based counseling and instructional video~Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
317834|NCT01198977|O2|Outcome|Education Counseling|"Exercise information and instructional video~Informational video: Mailed video of exercise programs"
317835|NCT01198977|O1|Outcome|Telephone Counseling|"Telephone based counseling and instructional video~Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
317836|NCT01198977|O2|Outcome|Education Counseling|"Exercise information and instructional video~Informational video: Mailed video of exercise programs"
317837|NCT01198977|O1|Outcome|Telephone Counseling|"Telephone based counseling and instructional video~Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
317838|NCT01198977|O2|Outcome|Education Counseling|"Self-directed physical activity information and instructional video~Informational video: Mailed video of Physical activity programs"
317839|NCT01198977|O1|Outcome|Telephone Counseling|"Telephone based counseling and instructional video~Intervention of brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
317840|NCT01198977|E2|Reported Event|Education Counseling|"Exercise information and instructional video (Control)~Informational video: Mailed video of exercise programs"
317841|NCT01198977|E1|Reported Event|Telephone Counseling|"Telephone based counseling and instructional video (Intervention)~Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
317842|NCT01198873|B3|Baseline|Total|Total of all reporting groups
317843|NCT01198873|B2|Baseline|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
317844|NCT01198873|B1|Baseline|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
317845|NCT01198873|P2|Participant Flow|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
317846|NCT01198873|P1|Participant Flow|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
317854|NCT01198873|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
317855|NCT01198873|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
317856|NCT01198873|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
317857|NCT01198873|E2|Reported Event|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
317858|NCT01198873|E1|Reported Event|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
317859|NCT01198795|B1|Baseline|Escitalopram|Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
317860|NCT01198795|P1|Participant Flow|Escitalopram|Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
317861|NCT01198795|O1|Outcome|Escitalopram|Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
317862|NCT01198795|E1|Reported Event|Escitalopram|Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
317863|NCT01198769|B1|Baseline|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
317864|NCT01198769|P1|Participant Flow|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
317865|NCT01198769|O1|Outcome|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
317866|NCT01198769|O1|Outcome|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
317867|NCT01198769|O1|Outcome|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
317868|NCT01198769|O1|Outcome|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
317869|NCT01198769|O1|Outcome|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
317870|NCT01198769|O1|Outcome|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
317871|NCT01198769|E1|Reported Event|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
317872|NCT01198756|B5|Baseline|Total|Total of all reporting groups
317873|NCT01198756|B4|Baseline|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
317874|NCT01198756|B3|Baseline|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317875|NCT01198756|B2|Baseline|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317876|NCT01198756|B1|Baseline|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317877|NCT01198756|P4|Participant Flow|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
317878|NCT01198756|P3|Participant Flow|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317879|NCT01198756|P2|Participant Flow|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317880|NCT01198756|P1|Participant Flow|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317881|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
317882|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317883|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317884|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317885|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
317886|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317887|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317888|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317889|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
317890|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317891|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317892|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317893|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
317894|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317895|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317896|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317897|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
317898|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317899|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317900|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317901|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317902|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317903|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317904|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
317905|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317906|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318025|NCT01198574|O3|Outcome|Iron and Vitamin A Group|60 mg Elemental iron with 2.5 mg folic acid + Vitamin A 15,000 IU
318463|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
317907|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317908|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317909|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317910|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317911|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
317912|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317913|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317914|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317915|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
317916|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317917|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317918|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317919|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
317920|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317921|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317922|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317923|NCT01198756|O7|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
317924|NCT01198756|O6|Outcome|Yamagata Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317925|NCT01198756|O5|Outcome|Yamagata Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317926|NCT01198756|O4|Outcome|Victoria Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317927|NCT01198756|O3|Outcome|Victoria Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318026|NCT01198574|O2|Outcome|Vitamin A Group|15,000 IU vitamin A + Iron Placebo containing 2.5 mg folic acid
317928|NCT01198756|O2|Outcome|GSK2282512A 1 (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317929|NCT01198756|O1|Outcome|GSK2282512A 1 (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317930|NCT01198756|O7|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
317931|NCT01198756|O6|Outcome|Yamagata Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317932|NCT01198756|O5|Outcome|Yamagata Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317933|NCT01198756|O4|Outcome|Victoria Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317934|NCT01198756|O3|Outcome|Victoria Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317935|NCT01198756|O2|Outcome|GSK2282512A 1 (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317936|NCT01198756|O1|Outcome|GSK2282512A 1 (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317937|NCT01198756|O7|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
317938|NCT01198756|O6|Outcome|Yamagata Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317939|NCT01198756|O5|Outcome|Yamagata Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317940|NCT01198756|O4|Outcome|Victoria Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317941|NCT01198756|O3|Outcome|Victoria Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317942|NCT01198756|O2|Outcome|GSK2282512A 1 (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317943|NCT01198756|O1|Outcome|GSK2282512A 1 (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317944|NCT01198756|O7|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
317945|NCT01198756|O6|Outcome|Yamagata Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317946|NCT01198756|O5|Outcome|Yamagata Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317947|NCT01198756|O4|Outcome|Victoria Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317948|NCT01198756|O3|Outcome|Victoria Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317949|NCT01198756|O2|Outcome|GSK2282512A 1 (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317950|NCT01198756|O1|Outcome|GSK2282512A 1 (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317951|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
317952|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317953|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317954|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317955|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
317956|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317957|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317958|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317959|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
317960|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317961|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317962|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317963|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
317964|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317965|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317966|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317967|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
317968|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317969|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318027|NCT01198574|O1|Outcome|Iron Group|60 mg Elemental iron with 2.5 mg folic acid + Vitamin A placebo
318028|NCT01198574|O4|Outcome|Placebo Group|2.5 mg folic acid + Vitamin A placebo
317970|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317971|NCT01198756|E4|Reported Event|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
317972|NCT01198756|E3|Reported Event|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317973|NCT01198756|E2|Reported Event|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317974|NCT01198756|E1|Reported Event|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
317975|NCT01198691|B3|Baseline|Total|Total of all reporting groups
317976|NCT01198691|B2|Baseline|Case Group|"This group will receive the Insorb absorbable staples to close their incision.~Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
317977|NCT01198691|B1|Baseline|Control Group|"This group will receive the standard metallic staples to close their incision.~Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
317978|NCT01198691|P2|Participant Flow|Case Group|"This group will receive the Insorb absorbable staples to close their incision.~Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
317979|NCT01198691|P1|Participant Flow|Control Group|"This group will receive the standard metallic staples to close their incision.~Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
317980|NCT01198691|O2|Outcome|Case Group|"This group will receive the Insorb absorbable staples to close their incision.~Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
317981|NCT01198691|O1|Outcome|Control Group|"This group will receive the standard metallic staples to close their incision.~Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
317982|NCT01198691|O2|Outcome|Case Group|"This group will receive the Insorb absorbable staples to close their incision.~Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
317983|NCT01198691|O1|Outcome|Control Group|"This group will receive the standard metallic staples to close their incision.~Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
317984|NCT01198691|O2|Outcome|Case Group|"This group will receive the Insorb absorbable staples to close their incision.~Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
317985|NCT01198691|O1|Outcome|Control Group|"This group will receive the standard metallic staples to close their incision.~Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
317986|NCT01198691|O2|Outcome|Case Group|"This group will receive the Insorb absorbable staples to close their incision.~Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
317987|NCT01198691|O1|Outcome|Control Group|"This group will receive the standard metallic staples to close their incision.~Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
317988|NCT01198691|E2|Reported Event|Case Group|"This group will receive the Insorb absorbable staples to close their incision.~Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
317989|NCT01198691|E1|Reported Event|Control Group|"This group will receive the standard metallic staples to close their incision.~Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
317990|NCT01198600|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed participants.
317991|NCT01198600|P4|Participant Flow|Phase 3: Lotrafilcon B Replacement Replacement|Contact lenses worn for 43 days with replacement pair dispensed on Day 1 and Day 28.
317992|NCT01198600|P3|Participant Flow|Phase 2: Lotrafilcon B Replacement|Contact lenses worn for 56 days with replacement pair dispensed at Day 28.
317993|NCT01198600|P2|Participant Flow|Phase 1: Habitual Replacement, Then Habitual no Replacement|Contact lenses per participant's habitual prescription worn for 30 days with a new pair dispensed at Day 28, followed by contact lenses per habitual prescription worn for 30 days with no replacement.
317994|NCT01198600|P1|Participant Flow|Phase 1: Habitual no Replacement, Then Habitual Replacement|Contact lenses per participant's habitual prescription worn for 30 days with no replacement, followed by contact lenses per habitual prescription worn for 30 days with a new pair dispensed at Day 28.
317995|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
317996|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
318029|NCT01198574|O3|Outcome|Iron and Vitamin A Group|60 mg Elemental iron with 2.5 mg folic acid + Vitamin A 15,000 IU
318030|NCT01198574|O2|Outcome|Vitamin A Group|15,000 IU vitamin A + Iron Placebo containing 2.5 mg folic acid
317997|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
317998|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
317999|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
318000|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
318001|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
318002|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
318003|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
318004|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
318005|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2.of Phase 2."
318006|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
318007|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
318008|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
318009|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
318010|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
318011|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
318012|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15 during Phase 3. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
318013|NCT01198600|E2|Reported Event|Lotrafilcon B Contact Lens|Contact lens worn for 56 days with a replacement dispensed at Day 28 in Phase 2, followed by 43 days in Phase 3 with a replacement dispensed at Day 1 and Day 14.
318014|NCT01198600|E1|Reported Event|Habitual Contact Lens|Contact lens per participant's habitual prescription worn for two 30-day periods in Phase 1, with a replacement dispensed at Day 28 in either Period 1 or Period 2.
318015|NCT01198574|B5|Baseline|Total|Total of all reporting groups
318016|NCT01198574|B4|Baseline|Placebo Group|Placebo group received iron placebo containing 2.5 mg folic acid weekly
318017|NCT01198574|B3|Baseline|Iron and Vitamin A Group|Iron and Vitamin A group received 60 mg elemental iron, 2.5 mg folic acid +15,000 IU Vitamin A weekly
318018|NCT01198574|B2|Baseline|Vitamin A Group|Vitamin A group received 15,000 IU Vitamin A + Iron placebo with 2.5 mg folic acid weekly
318019|NCT01198574|B1|Baseline|Iron Group|Iron group received 60 mg elemental iron, 2.5 mg folic acid with vitamin A placebo weekly
318020|NCT01198574|P4|Participant Flow|Placebo Group|Placebo group received 2.5 mg folic acid weekly
318021|NCT01198574|P3|Participant Flow|Iron and Vitamin A Group|Iron and Vitamin A group received 60 mg elemental iron, 2.5 mg folic acid + 15,000 IU Vitamin A weekly
318022|NCT01198574|P2|Participant Flow|Vitamin A Group|Vitamin A group received 15,000 IU Vitamin A + Placebo iron containing 2.5 mg folic acid weekly
318023|NCT01198574|P1|Participant Flow|Iron Group|Iron group received 60 mg of elemental iron, 2.5 mg folic acid + Placebo Vitamin A weekly
318024|NCT01198574|O4|Outcome|Placebo Group|2.5 mg folic acid + Vitamin A placebo
318033|NCT01198574|O3|Outcome|Iron and Vitamin A Group|60 mg Elemental iron with 2.5 mg folic acid + Vitamin A 15,000 IU
318034|NCT01198574|O2|Outcome|Vitamin A Group|15,000 IU vitamin A + Iron Placebo containing 2.5 mg folic acid
318035|NCT01198574|O1|Outcome|Iron Group|60 mg Elemental iron with 2.5 mg folic acid + Vitamin A placebo
318036|NCT01198574|E4|Reported Event|Placebo Group|Placebo group received iron placebo containing 2.5 mg folic acid weekly
318037|NCT01198574|E3|Reported Event|Iron and Vitamin A Group|Iron and Vitamin A group received 60 mg elemental iron, 2.5 mg folic acid +15,000 IU Vitamin A weekly
318038|NCT01198574|E2|Reported Event|Vitamin A Group|Vitamin A group received 15,000 IU Vitamin A + Iron placebo with 2.5 mg folic acid weekly
318039|NCT01198574|E1|Reported Event|Iron Group|Iron group received 60 mg elemental iron, 2.5 mg folic acid with vitamin A placebo weekly
318040|NCT01198548|B1|Baseline|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
318041|NCT01198548|P1|Participant Flow|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
318042|NCT01198548|O1|Outcome|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
318043|NCT01198548|O1|Outcome|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
318044|NCT01198548|O1|Outcome|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
318045|NCT01198548|O1|Outcome|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
318046|NCT01198548|O1|Outcome|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
318047|NCT01198548|O1|Outcome|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
318048|NCT01198548|E1|Reported Event|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
318049|NCT01198509|B7|Baseline|Total|Total of all reporting groups
318050|NCT01198509|B6|Baseline|Healthy Volunteers|Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.
318051|NCT01198509|B5|Baseline|Psoriatic Arthritis (PsA)|Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.
318052|NCT01198509|B4|Baseline|Early RA Cross-sectional Cohort|Patients with rheumatoid arthritis (RA) meeting inclusion criteria who opted to participate ONLY in cross-sectional analysis (one-time sample collection equivalent to the involvement of PsA and health control subjects).
318053|NCT01198509|B3|Baseline|Rheumatoid Arthritis (RA) Randomized to no Treatment|Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment and followed prospectively for 6 months, for comparison with Doxycycline- and Vancomycin-treated patients.
318054|NCT01198509|B2|Baseline|Rheumatoid Arthritis (RA) - Vancomycin|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks~vancomycin: vancomycin, 250 mg four times a day, for 2 weeks"
318055|NCT01198509|B1|Baseline|Rheumatoid Arthritis (RA) - Doxycycline|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.~doxycycline: doxycycline - 100 mg twice per day, for 2 months"
318056|NCT01198509|P6|Participant Flow|Healthy Volunteers|"Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.~N=58 (actual)"
318057|NCT01198509|P5|Participant Flow|Psoriatic Arthritis (PsA)|"Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.~N=20 (actual)"
318058|NCT01198509|P4|Participant Flow|Early RA Cross-sectional Cohort|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria who opted to participate ONLY in cross-sectional analysis (one-time sample collection equivalent to the involvement of PsA and health control subjects).~N=66 (actual)"
318059|NCT01198509|P3|Participant Flow|Rheumatoid Arthritis (RA) Randomized to no Treatment|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment for comparison with Doxycycline- and Vancomycin-treated patients.~N=19 (actual)"
318060|NCT01198509|P2|Participant Flow|Rheumatoid Arthritis (RA) - Vancomycin|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks~vancomycin: vancomycin, 250 mg four times a day, for 2 weeks~N=10 (actual)"
318061|NCT01198509|P1|Participant Flow|Rheumatoid Arthritis (RA) - Doxycycline|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.~doxycycline: doxycycline - 100 mg twice per day, for 2 months~N=5 (actual)"
318062|NCT01198509|O6|Outcome|Healthy Volunteers|"Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.~N=58 (actual)"
318063|NCT01198509|O5|Outcome|Psoriatic Arthritis (PsA)|"Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.~N=20 (actual)"
318064|NCT01198509|O4|Outcome|Early RA Cross-sectional Cohort|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria who opted to participate ONLY in cross-sectional analysis (one-time sample collection equivalent to the involvement of PsA and health control subjects).~N=66 (actual)"
318065|NCT01198509|O3|Outcome|Rheumatoid Arthritis (RA) Randomized to no Treatment|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment and followed prospectively for 6 months, for comparison with Doxycycline- and Vancomycin-treated patients.~N=19 (actual)"
318066|NCT01198509|O2|Outcome|Rheumatoid Arthritis (RA) - Vancomycin|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks~vancomycin: vancomycin, 250 mg four times a day, for 2 weeks"
318067|NCT01198509|O1|Outcome|Rheumatoid Arthritis (RA) - Doxycycline|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.~doxycycline: doxycycline - 100 mg twice per day, for 2 months"
318068|NCT01198509|O6|Outcome|Healthy Volunteers|"Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.~N=58 (actual)"
318069|NCT01198509|O5|Outcome|Psoriatic Arthritis (PsA)|"Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.~N=20 (actual)"
318070|NCT01198509|O4|Outcome|Early RA Cross-sectional Cohort|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria who opted to participate ONLY in cross-sectional analysis (one-time sample collection equivalent to the involvement of PsA and health control subjects).~N=66 (actual)"
318071|NCT01198509|O3|Outcome|Rheumatoid Arthritis (RA) Randomized to no Treatment|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment, followed prospectively for 6 months, for comparison with Doxycycline- and Vancomycin-treated patients.~N=19 (actual)"
318072|NCT01198509|O2|Outcome|Rheumatoid Arthritis (RA) - Vancomycin|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks~vancomycin: vancomycin, 250 mg four times a day, for 2 weeks"
318073|NCT01198509|O1|Outcome|Rheumatoid Arthritis (RA) - Doxycycline|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.~doxycycline: doxycycline - 100 mg twice per day, for 2 months"
318074|NCT01198509|E3|Reported Event|RA, PsA, Healthy|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment for comparison with Doxycycline- and Vancomycin-treated patients.~Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.~Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients."
318075|NCT01198509|E2|Reported Event|Rheumatoid Arthritis (RA) - Vancomycin|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks~vancomycin: vancomycin, 250 mg four times a day, for 2 weeks"
318076|NCT01198509|E1|Reported Event|Rheumatoid Arthritis (RA) - Doxycycline|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.~doxycycline: doxycycline - 100 mg twice per day, for 2 months"
318077|NCT01198366|B7|Baseline|Total|Total of all reporting groups
318078|NCT01198366|B6|Baseline|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.~Placebo: Sterile buffer"
318079|NCT01198366|B5|Baseline|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318080|NCT01198366|B4|Baseline|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318081|NCT01198366|B3|Baseline|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318082|NCT01198366|B2|Baseline|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318083|NCT01198366|B1|Baseline|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.~Placebo: Sterile buffer"
318084|NCT01198366|P6|Participant Flow|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.~Placebo: Sterile buffer"
318085|NCT01198366|P5|Participant Flow|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318086|NCT01198366|P4|Participant Flow|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318087|NCT01198366|P3|Participant Flow|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318088|NCT01198366|P2|Participant Flow|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318089|NCT01198366|P1|Participant Flow|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.~Placebo: Sterile buffer"
318090|NCT01198366|O6|Outcome|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.~Placebo: Sterile buffer"
318091|NCT01198366|O5|Outcome|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318092|NCT01198366|O4|Outcome|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318093|NCT01198366|O3|Outcome|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318094|NCT01198366|O2|Outcome|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318095|NCT01198366|O1|Outcome|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.~Placebo: Sterile buffer"
318096|NCT01198366|O6|Outcome|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.~Placebo: Sterile buffer"
318097|NCT01198366|O5|Outcome|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318098|NCT01198366|O4|Outcome|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318099|NCT01198366|O3|Outcome|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318100|NCT01198366|O2|Outcome|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318101|NCT01198366|O1|Outcome|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.~Placebo: Sterile buffer"
318102|NCT01198366|O6|Outcome|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.~Placebo: Sterile buffer"
318103|NCT01198366|O5|Outcome|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318104|NCT01198366|O4|Outcome|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318105|NCT01198366|O3|Outcome|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318106|NCT01198366|O2|Outcome|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318107|NCT01198366|O1|Outcome|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.~Placebo: Sterile buffer"
318108|NCT01198366|O6|Outcome|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.~Placebo: Sterile buffer"
318109|NCT01198366|O5|Outcome|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318110|NCT01198366|O4|Outcome|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318111|NCT01198366|O3|Outcome|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318112|NCT01198366|O2|Outcome|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318113|NCT01198366|O1|Outcome|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.~Placebo: Sterile buffer"
318114|NCT01198366|O6|Outcome|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.~Placebo: Sterile buffer"
318115|NCT01198366|O5|Outcome|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318116|NCT01198366|O4|Outcome|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318117|NCT01198366|O3|Outcome|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318118|NCT01198366|O2|Outcome|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
318119|NCT01198366|O1|Outcome|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.~Placebo: Sterile buffer"
318120|NCT01198366|E6|Reported Event|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo (sterile buffer) on days 0, 28 and 280.~Placebo"
318121|NCT01198366|E5|Reported Event|Expanded Safety Phase - Group 5|Subjects received 3 doses of AERAS-402 (1.0 X 10^11 vp) on days 0, 28 and 280.
318122|NCT01198366|E4|Reported Event|Dose Finding - Group 4|Subjects received two doses of AERAS-402 (1.0 x 10^11 vp) on study days 0 and 28.
318123|NCT01198366|E3|Reported Event|Dose Finding - Group 3|Subjects received two doses of AERAS-402 (3.0 x 10^10 vp) on study days 0 and 28.
318124|NCT01198366|E2|Reported Event|Dose Finding - Group 2|Subjects received two doses of AERAS-402 (1.5 x 10^10 vp) on study days 0 and 28.
318125|NCT01198366|E1|Reported Event|Dose Finding - Group 1|Subjects received two doses of placebo (sterile buffer) on study days 0 and 28.
318126|NCT01198327|B1|Baseline|Ranibizumab as Needed|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.
318127|NCT01198327|P1|Participant Flow|Ranibizumab as Needed|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.
318128|NCT01198327|O2|Outcome|Ranibizumab as Needed -BRVO|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion. BRVO stands for branch retinal vein occlusion.
318129|NCT01198327|O1|Outcome|Ranibizumab as Needed -CRVO|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion. CRVO stands for central retinal vein occlusion.
318130|NCT01198327|O2|Outcome|Ranibizumab as Needed -BRVO|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion. BRVO stands for branch retinal vein occlusion.
318131|NCT01198327|O1|Outcome|Ranibizumab as Needed -CRVO|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion. CRVO stands for Central retinal vein occlusion.
318132|NCT01198327|O1|Outcome|Ranibizumab as Needed|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.
318133|NCT01198327|E1|Reported Event|Ranibizumab as Needed|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.
318134|NCT01198275|B3|Baseline|Total|Total of all reporting groups
318135|NCT01198275|B2|Baseline|Placebo|1.0 g placebo gelatine capsules(olive oil)twice daily
318136|NCT01198275|B1|Baseline|n-3 PUFAs|1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily
318137|NCT01198275|P2|Participant Flow|Placebo|1.0 g placebo gelatine capsules(olive oil)twice daily
318138|NCT01198275|P1|Participant Flow|n-3 PUFAs|1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily
318139|NCT01198275|O2|Outcome|Placebo|1.0 g placebo gelatine capsules(olive oil)twice daily
318140|NCT01198275|O1|Outcome|n-3 PUFAs|1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily
318141|NCT01198275|E2|Reported Event|Placebo|1.0 g placebo gelatine capsules(olive oil)twice daily
318142|NCT01198275|E1|Reported Event|n-3 PUFAs|1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily
318143|NCT01198145|B3|Baseline|Total|Total of all reporting groups
318144|NCT01198145|B2|Baseline|Arm II: Placebo|"Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy. >~> placebo: Given orally"
318145|NCT01198145|B1|Baseline|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
318146|NCT01198145|P2|Participant Flow|Arm II: Placebo|"Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.~>~> placebo: Given orally"
318147|NCT01198145|P1|Participant Flow|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
318148|NCT01198145|O2|Outcome|Arm II: Placebo|Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
318149|NCT01198145|O1|Outcome|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
318150|NCT01198145|O2|Outcome|Arm II: Placebo|Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
318151|NCT01198145|O1|Outcome|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
318152|NCT01198145|O2|Outcome|Arm II: Placebo|Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
318153|NCT01198145|O1|Outcome|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
318154|NCT01198145|O2|Outcome|Arm II: Placebo|Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
318155|NCT01198145|O1|Outcome|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
318156|NCT01198145|O2|Outcome|Arm II: Placebo|Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
318157|NCT01198145|O1|Outcome|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
318158|NCT01198145|O2|Outcome|Arm II: Placebo|Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
318159|NCT01198145|O1|Outcome|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
318160|NCT01198145|O2|Outcome|Arm II: Placebo|Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
318161|NCT01198145|O1|Outcome|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
318162|NCT01198145|O2|Outcome|Arm II: Placebo|"Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.~>~> placebo: Given orally"
318163|NCT01198145|O1|Outcome|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
318164|NCT01198145|E2|Reported Event|Arm II: Placebo|placebo: Given orally
318165|NCT01198145|E1|Reported Event|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
318166|NCT01198132|B3|Baseline|Total|Total of all reporting groups
318167|NCT01198132|B2|Baseline|Placebo|Subjects received matching placebo to Cholecalciferol once every two weeks orally along with subcutaneous injection of Rebif 44 mcg 3 times weekly.
318168|NCT01198132|B1|Baseline|Cholecalciferol|Subjects received Cholecalciferol 100,000 IU one dose fortnightly (equivalent to a daily dose of approximately 7142 IU) for 96 weeks treatment period along with subcutaneous Rebif 44 mcg 3 times a week.
318169|NCT01198132|P2|Participant Flow|Placebo|Subjects received matching placebo to Cholecalciferol once every two weeks orally along with subcutaneous injection of Rebif 44 mcg 3 times weekly.
318170|NCT01198132|P1|Participant Flow|Cholecalciferol|Subjects received Cholecalciferol 100,000 IU one dose fortnightly (equivalent to a daily dose of approximately 7142 IU) for 96 weeks treatment period along with subcutaneous Rebif 44 mcg 3 times a week.
318171|NCT01198132|O2|Outcome|Placebo|Subjects received matching placebo to Cholecalciferol once every two weeks orally along with subcutaneous injection of Rebif 44 mcg 3 times weekly.
318172|NCT01198132|O1|Outcome|Cholecalciferol|Subjects received Cholecalciferol 100,000 IU one dose fortnightly (equivalent to a daily dose of approximately 7142 IU) for 96 weeks treatment period along with subcutaneous Rebif 44 mcg 3 times a week.
318173|NCT01198132|O2|Outcome|Placebo|Subjects received matching placebo to Cholecalciferol once every two weeks orally along with subcutaneous injection of Rebif 44 mcg 3 times weekly.
318174|NCT01198132|O1|Outcome|Cholecalciferol|Subjects received Cholecalciferol 100,000 IU one dose fortnightly (equivalent to a daily dose of approximately 7142 IU) for 96 weeks treatment period along with subcutaneous Rebif 44 mcg 3 times a week.
318175|NCT01198132|O2|Outcome|Placebo|Subjects received matching placebo to Cholecalciferol once every two weeks orally along with sub-cutaneous injection of Rebif 44 mcg 3 times weekly.
318176|NCT01198132|O1|Outcome|Cholecalciferol|Subjects received Cholecalciferol 100,000 IU one dose fortnightly (equivalent to a daily dose of approximately 7142 IU) for 96 weeks treatment period along with subcutaneous Rebif 44 mcg 3 times a week.
318177|NCT01198132|O2|Outcome|Placebo|Subjects received matching placebo to Cholecalciferol once every two weeks orally along with subcutaneous injection of Rebif 44 mcg 3 times weekly.
318178|NCT01198132|O1|Outcome|Cholecalciferol|Subjects received Cholecalciferol 100,000 IU one dose fortnightly (equivalent to a daily dose of approximately 7142 IU) for 96 weeks treatment period along with subcutaneous Rebif 44 mcg 3 times a week.
318179|NCT01198132|O2|Outcome|Placebo|Subjects received matching placebo to Cholecalciferol once every two weeks orally along with subcutaneous injection of Rebif 44 mcg 3 times weekly.
318180|NCT01198132|O1|Outcome|Cholecalciferol|Subjects received Cholecalciferol 100,000 IU one dose fortnightly (equivalent to a daily dose of approximately 7142 IU) for 96 weeks treatment period along with subcutaneous Rebif 44 mcg 3 times a week.
318181|NCT01198132|O2|Outcome|Placebo|Subjects received matching placebo to Cholecalciferol once every two weeks orally along with subcutaneous injection of Rebif 44 mcg 3 times weekly.
318182|NCT01198132|O1|Outcome|Cholecalciferol|Subjects received Cholecalciferol 100,000 IU one dose fortnightly (equivalent to a daily dose of approximately 7142 IU) for 96 weeks treatment period along with subcutaneous Rebif 44 mcg 3 times a week.
318183|NCT01198132|O2|Outcome|Placebo|Subjects received matching placebo to Cholecalciferol once every two weeks orally along with subcutaneous injection of Rebif 44 mcg 3 times weekly.
318184|NCT01198132|O1|Outcome|Cholecalciferol|Subjects received Cholecalciferol 100,000 IU one dose fortnightly (equivalent to a daily dose of approximately 7142 IU) for 96 weeks treatment period along with subcutaneous Rebif 44 mcg 3 times a week.
318185|NCT01198132|O2|Outcome|Placebo|Subjects received matching placebo to Cholecalciferol once every two weeks orally along with subcutaneous injection of Rebif 44 mcg 3 times weekly.
318186|NCT01198132|O1|Outcome|Cholecalciferol|Subjects received Cholecalciferol 100,000 IU one dose fortnightly (equivalent to a daily dose of approximately 7142 IU) for 96 weeks treatment period along with subcutaneous Rebif 44 mcg 3 times a week.
318187|NCT01198132|O2|Outcome|Rebif +Placebo|Subjects received matching placebo to Cholecalciferol once every two weeks orally along with subcutaneous injection of Rebif 44 mcg 3 times weekly.
318188|NCT01198132|O1|Outcome|Cholecalciferol|Subjects received Cholecalciferol 100,000 IU one dose fortnightly (equivalent to a daily dose of approximately 7142 IU) for 96 weeks treatment period along with subcutaneous Rebif 44 mcg 3 times a week.
318189|NCT01198132|O2|Outcome|Placebo|Subjects received matching placebo to Cholecalciferol once every two weeks orally along with subcutaneous injection of Rebif 44 mcg 3 times weekly.
318190|NCT01198132|O1|Outcome|Cholecalciferol|Subjects received Cholecalciferol 100,000 IU one dose fortnightly (equivalent to a daily dose of approximately 7142 IU) for 96 weeks treatment period along with subcutaneous Rebif 44 mcg 3 times a week.
318191|NCT01198132|E2|Reported Event|Placebo|Subjects received matching placebo to Cholecalciferol once every two weeks orally along with subcutaneous injection of Rebif 44 mcg 3 times weekly.
318192|NCT01198132|E1|Reported Event|Cholecalciferol|Subjects received Cholecalciferol 100,000 IU one dose fortnightly (equivalent to a daily dose of approximately 7142 IU) for 96 weeks treatment period along with subcutaneous Rebif 44 mcg 3 times a week.
318193|NCT01198002|B4|Baseline|Total|Total of all reporting groups
318194|NCT01198002|B3|Baseline|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318195|NCT01198002|B2|Baseline|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318196|NCT01198002|B1|Baseline|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318197|NCT01198002|P3|Participant Flow|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318347|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318464|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
318198|NCT01198002|P2|Participant Flow|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318199|NCT01198002|P1|Participant Flow|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 milligrams (mg) (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered subcutaneously (SC) every 4 weeks (Q4W). For blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks (Q2W).~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318200|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318201|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318202|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318203|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318204|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318205|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2."
318206|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318207|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318465|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
318208|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318209|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318210|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318211|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2."
318212|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318213|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318214|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2."
318215|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318216|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318217|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2."
318218|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318348|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318349|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318219|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318220|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2."
318221|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318222|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318223|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2."
318224|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318225|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318226|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2."
318227|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318228|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318229|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2."
318283|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318230|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318231|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318232|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2."
318233|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318234|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318235|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2."
318236|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318237|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318238|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318239|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318240|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318350|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318241|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2."
318242|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318243|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318244|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318245|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318246|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318247|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318248|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318249|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318250|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2."
318351|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318466|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
318251|NCT01198002|O1|Outcome|LY2127399|"A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 100 weeks or a loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 100 weeks. At Weeks 16 and 52, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 100-week treatment period or 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318252|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318253|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318254|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2."
318255|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318256|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318257|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318258|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318259|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318260|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2."
318304|NCT01198002|E6|Reported Event|Placebo to LY 90 mg Q2W (Week 16), Rescue Period|"A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 16 weeks during Treatment Period 1.~At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 52-week Treatment Period 1.~The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the Treatment Period 1 for Week 16 NR."
318261|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318262|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318263|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2."
318264|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318265|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318266|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2."
318267|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318268|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318269|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2."
318270|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318271|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318305|NCT01198002|E5|Reported Event|LY 90 mg Q2W, Rescue Period|"A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 16 weeks during Treatment Period 1.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 52-week Treatment Period 1.~The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the Treatment Period 1 for Week 16 NR."
318458|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
318272|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2."
318273|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318274|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318275|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2."
318276|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318277|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318278|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2."
318279|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318280|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318281|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2."
318282|NCT01198002|O3|Outcome|Placebo|"Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318339|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318340|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318341|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318284|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2."
318285|NCT01198002|O3|Outcome|Placebo|"Placebo Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318286|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318287|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period."
318288|NCT01198002|O3|Outcome|Placebo|"Placebo Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.~At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318289|NCT01198002|O2|Outcome|90 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.~At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2."
318290|NCT01198002|O1|Outcome|120 mg LY2127399|"Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.~Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2."
318291|NCT01198002|E19|Reported Event|Placebo, Follow-up Period|"A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~The Post-Treatment Follow-Up Period started after Week 52 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
318292|NCT01198002|E18|Reported Event|Placebo to LY 90 mg Q2W (Week 16), Follow-up Period|"A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 16 weeks during Treatment Period 1.~At Week 16, Week 16 NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 52-week Treatment Period 1.~During non-blinded Treatment Period 2, Week 16 NR received 1 injection of 90 mg of LY2127399.~The Post-Treatment Follow-Up Period started after Week 100 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
318293|NCT01198002|E17|Reported Event|LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Follow-up Period|"A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 16 weeks during Treatment Period 1. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, Week 16 NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 52-week Treatment Period 1.~During non-blinded Treatment Period 2, Week 16 NR received 1 injection of 90 mg of LY2127399.~The Post-Treatment Follow-Up Period started after Week 100 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
318342|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318343|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318344|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318459|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
318294|NCT01198002|E16|Reported Event|Placebo to LY 90 mg Q2W (Week 52), Follow-up Period|"A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, Week 16 responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~At Week 52, Week 16 responders were randomized to receive 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q4W for the rest of the Treatment Period 2~The Post-Treatment Follow-Up Period started after Week 100 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
318295|NCT01198002|E15|Reported Event|Placebo to LY 120 mg Q4W (Week 52), Follow-up Period|"A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, Week 16 responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~At Week 52, Week 16 responders were randomized to receive 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2~The Post-Treatment Follow-Up Period started after Week 100 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
318296|NCT01198002|E14|Reported Event|LY 90 mg Q2W, Follow-up Period|"A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, both Week 16 responders and NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~At Week 52, both Week 16 responders and NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~The Post-Treatment Follow-Up Period started after Week 100 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
318297|NCT01198002|E13|Reported Event|LY 120 mg Q4W, Follow-up Period|"A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 52 weeks during Treatment Period 1. At Week 16, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 52-week Treatment Period 1. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.~The Post-Treatment Follow-Up Period started after Week 100 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment."
318298|NCT01198002|E12|Reported Event|Placebo to LY 90 mg Q2W (Week 16), Treatment Period 2|"A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 16 weeks during Treatment Period 1.~At Week 16, Week 16 NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 52-week Treatment Period 1.~During non-blinded Treatment Period 2, Week 16 NR received 1 injection of 90 mg of LY2127399.~Treatment Period 2 was defined as all data collected from Week 52 to Week 100 during non-blinded Treatment Period 2."
318299|NCT01198002|E11|Reported Event|LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Treatment Period 2|"A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 16 weeks during Treatment Period 1. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, Week 16 NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 52-week Treatment Period 1.~During non-blinded Treatment Period 2, Week 16 NR received 1 injection of 90 mg of LY2127399.~Treatment Period 2 was defined as all data collected from Week 52 to Week 100 during non-blinded Treatment Period 2."
318300|NCT01198002|E10|Reported Event|Placebo to LY 90 mg Q2W (Week 52), Treatment Period 2|"A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, Week 16 responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~At Week 52, Week 16 responders were randomized to receive 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q4W for the rest of the Treatment Period 2~Treatment Period 2 was defined as all data collected from Week 52 to Week 100 during non-blinded Treatment Period 2."
318301|NCT01198002|E9|Reported Event|Placebo to LY 120 mg Q4W (Week 52), Treatment Period 2|"A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, Week 16 responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~At Week 52, Week 16 responders were randomized to receive 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2~Treatment Period 2 was defined as all data collected from Week 52 to Week 100 during non-blinded Treatment Period 2."
318302|NCT01198002|E8|Reported Event|LY 90 mg Q2W, Treatment Period 2|"A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, both Week 16 responders and NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~At Week 52, both Week 16 responders and NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.~Treatment Period 2 was defined as all data collected from Week 52 to Week 100 during non-blinded Treatment Period 2."
318303|NCT01198002|E7|Reported Event|LY 120 mg Q4W, Treatment Period 2|"A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 52 weeks during Treatment Period 1. At Week 16, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 52-week Treatment Period 1. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.~Treatment Period 2 was defined as all data collected from Week 52 to Week 100 during non-blinded Treatment Period 2."
318345|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318346|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318306|NCT01198002|E4|Reported Event|LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Rescue Period|"A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 16 weeks during Treatment Period 1. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 52-week Treatment Period 1.~The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the Treatment Period 1 for Week 16 NR."
318307|NCT01198002|E3|Reported Event|Placebo, Randomized Treatment Period 1|"A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.~The Randomized Treatment Period 1 was defined as the time all data was collected during the Treatment Period 1, excluding the data collected after the date of the Week 16 injection for the Week 16 NR."
318308|NCT01198002|E2|Reported Event|LY 90 mg Q2W, Randomized Treatment Period 1|"A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.~The Randomized Treatment Period 1 was defined as the time all data was collected during the Treatment Period 1, excluding the data collected after the date of the Week 16 injection for the Week 16 NR."
318309|NCT01198002|E1|Reported Event|LY 120 mg Q4W, Randomized Treatment Period 1|"A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 52 weeks during Treatment Period 1. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 52-week Treatment Period 1. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.~The Randomized Treatment Period 1 was defined as the time all data was collected during the Treatment Period 1, excluding the data collected after the date of the Week 16 injection for the Week 16 NR."
318310|NCT01197911|B4|Baseline|Total|Total of all reporting groups
318311|NCT01197911|B3|Baseline|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318312|NCT01197911|B2|Baseline|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318313|NCT01197911|B1|Baseline|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318314|NCT01197911|P3|Participant Flow|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318315|NCT01197911|P2|Participant Flow|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318316|NCT01197911|P1|Participant Flow|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318317|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318318|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318319|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318320|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318321|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318322|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318323|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318324|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318325|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318326|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318327|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318328|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318329|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318330|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318331|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318332|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318333|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318334|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318335|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318336|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318337|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318338|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318352|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318353|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318354|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318355|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318356|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318357|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318358|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318359|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318360|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318361|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318362|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318363|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318364|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318365|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318366|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318367|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318368|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318369|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318370|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318371|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318372|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318373|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318374|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318375|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318376|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318377|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318378|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318379|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318380|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318381|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318382|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318383|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318384|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318385|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318386|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318387|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318388|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 mcg tablet
318389|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318390|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318391|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318392|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318393|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318394|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318395|NCT01197911|E3|Reported Event|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318396|NCT01197911|E2|Reported Event|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
318397|NCT01197911|E1|Reported Event|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
318398|NCT01197898|B3|Baseline|Total|Total of all reporting groups
318399|NCT01197898|B2|Baseline|Vehicle Base|"Applied once daily~Placebo Comparator : Topical daily application"
318400|NCT01197898|B1|Baseline|Collagenase Santyl Ointment|"Applied once daily~Collagenase Santyl Ointment : Topical daily application"
318401|NCT01197898|P2|Participant Flow|Vehicle Base|"Applied once daily~Placebo Comparator : Topical daily application"
318402|NCT01197898|P1|Participant Flow|Collagenase Santyl Ointment|"Applied once daily~Collagenase Santyl Ointment : Topical daily application"
318403|NCT01197898|O2|Outcome|Vehicle Base|"Applied once daily~Placebo Comparator : Topical daily application"
318404|NCT01197898|O1|Outcome|Collagenase Santyl Ointment|"Applied once daily~Collagenase Santyl Ointment : Topical daily application"
318405|NCT01197898|E2|Reported Event|Vehicle Base|"Applied once daily~Placebo Comparator : Topical daily application"
318406|NCT01197898|E1|Reported Event|Collagenase Santyl Ointment|"Applied once daily~Collagenase Santyl Ointment : Topical daily application"
318407|NCT01197833|B4|Baseline|Total|Total of all reporting groups
318408|NCT01197833|B3|Baseline|Endovenous Ablation, Polidocanol Injectable Foam 1.0%|endovenous ablation followed by polidocanol injectable foam 1.0%
318409|NCT01197833|B2|Baseline|Endovenous Ablation, Polidocanol Injectable Foam, 0.5%|Endovenous ablation followed by polidocanol injectable foam, 0.5%
318410|NCT01197833|B1|Baseline|Endovenous Ablation, Vehicle Placebo|Endovenous ablation followed by vehicle placebo
318411|NCT01197833|P3|Participant Flow|Endovenous Ablation, Polidocanol Injectable Foam 1.0%|endovenous ablation followed by polidocanol injectable foam 1.0%
318412|NCT01197833|P2|Participant Flow|Endovenous Ablation, Polidocanol Injectable Foam, 0.5%|Endovenous ablation followed by polidocanol injectable foam, 0.5%
318413|NCT01197833|P1|Participant Flow|Endovenous Ablation, Vehicle Placebo|Endovenous ablation followed by vehicle placebo
318414|NCT01197833|O3|Outcome|Endovenous Ablation, Polidocanol Injectable Foam 1.0%|endovenous ablation followed by polidocanol injectable foam 1.0%
318415|NCT01197833|O2|Outcome|Endovenous Ablation, Polidocanol Injectable Foam, 0.5%|Endovenous ablation followed by polidocanol injectable foam, 0.5%
318416|NCT01197833|O1|Outcome|Endovenous Ablation, Vehicle Placebo|Endovenous ablation followed by vehicle placebo
318417|NCT01197833|O3|Outcome|Endovenous Ablation, Polidocanol Injectable Foam 1.0%|endovenous ablation followed by polidocanol injectable foam 1.0%
318418|NCT01197833|O2|Outcome|Endovenous Ablation, Polidocanol Injectable Foam, 0.5%|Endovenous ablation followed by polidocanol injectable foam, 0.5%
318419|NCT01197833|O1|Outcome|Endovenous Ablation, Vehicle Placebo|Endovenous ablation followed by vehicle placebo
318420|NCT01197833|E3|Reported Event|Endovenous Ablation, Polidocanol Injectable Foam 1.0%|endovenous ablation followed by polidocanol injectable foam 1.0%
318421|NCT01197833|E2|Reported Event|Endovenous Ablation, Polidocanol Injectable Foam, 0.5%|Endovenous ablation followed by polidocanol injectable foam, 0.5%
318422|NCT01197833|E1|Reported Event|Endovenous Ablation, Vehicle Placebo|Endovenous ablation followed by vehicle placebo
318423|NCT01197794|B8|Baseline|Total|Total of all reporting groups
318424|NCT01197794|B7|Baseline|Placebo|Placebo
318425|NCT01197794|B6|Baseline|AZD1981 10 mg|AZD1981 10 mg twice daily
318426|NCT01197794|B5|Baseline|AZD1981 40 mg|AZD1981 40 mg twice daily
318427|NCT01197794|B4|Baseline|AZD1981 80 mg|AZD1981 80 mg once daily
318428|NCT01197794|B3|Baseline|AZD1981 100 mg|AZD1981 100 mg twice daily
318429|NCT01197794|B2|Baseline|AZD1981 200 mg|AZD1981 200 mg once daily
318430|NCT01197794|B1|Baseline|AZD1981 400 mg|AZD1981 400 mg twice daily
318431|NCT01197794|P7|Participant Flow|Placebo|Placebo
318432|NCT01197794|P6|Participant Flow|AZD1981 10 mg|AZD1981 10 mg twice daily
318433|NCT01197794|P5|Participant Flow|AZD1981 40 mg|AZD1981 40 mg twice daily
318434|NCT01197794|P4|Participant Flow|AZD1981 80 mg|AZD1981 80 mg once daily
318435|NCT01197794|P3|Participant Flow|AZD1981 100 mg|AZD1981 100 mg twice daily
318436|NCT01197794|P2|Participant Flow|AZD1981 200 mg|AZD1981 200 mg once daily
318437|NCT01197794|P1|Participant Flow|AZD1981 400 mg|AZD1981 400 mg twice daily
318438|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
318439|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
318440|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
318441|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
318442|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
318443|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
318444|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
318445|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
318446|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
318447|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
318448|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
318449|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
318450|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
318451|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
318452|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
318453|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
318454|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
318455|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
318456|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
318457|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
318467|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
318468|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
318469|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
318470|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
318471|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
318472|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
318473|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
318474|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
318475|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
318476|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
318477|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
318478|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
318479|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
318480|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
318481|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
318482|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
318483|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
318484|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
318485|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
318486|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
318487|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
318488|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
318489|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
318490|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
318491|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
318492|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
318493|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
318494|NCT01197794|O7|Outcome|Arm 7-Placebo|Placebo
318495|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
318496|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
318497|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
318498|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
318499|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
318500|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
318501|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
318502|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
318503|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
318504|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
318505|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
318506|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
318507|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
318508|NCT01197794|E7|Reported Event|Placebo|Placebo
318509|NCT01197794|E6|Reported Event|AZD1981 10 mg|AZD1981 10 mg twice daily
318510|NCT01197794|E5|Reported Event|AZD1981 40 mg|AZD1981 40 mg twice daily
318511|NCT01197794|E4|Reported Event|AZD1981 80 mg|AZD1981 80 mg once daily
318512|NCT01197794|E3|Reported Event|AZD1981 100 mg|AZD1981 100 mg twice daily
318513|NCT01197794|E2|Reported Event|AZD1981 200 mg|AZD1981 200 mg once daily
318514|NCT01197794|E1|Reported Event|AZD1981 400 mg|AZD1981 400 mg twice daily
318515|NCT01197755|B4|Baseline|Total|Total of all reporting groups
318516|NCT01197755|B3|Baseline|PLACEBO PO|Dosing Group C
318517|NCT01197755|B2|Baseline|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318518|NCT01197755|B1|Baseline|FOSTA 100 MG BID PO|Dosing Group A
318519|NCT01197755|P3|Participant Flow|PLACEBO PO|Dosing Group C
318520|NCT01197755|P2|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318521|NCT01197755|P1|Participant Flow|FOSTA 100 MG BID PO|Dosing Group A
318522|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
318523|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318524|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318525|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
318526|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318527|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318528|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
318529|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318530|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318531|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
318532|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318533|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318534|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
318535|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318536|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318537|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
318538|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318539|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318540|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
318541|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318542|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318543|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
318544|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318545|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318546|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
318547|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318548|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318549|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
318550|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318551|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318552|NCT01197755|O2|Outcome|Dosing Group A and B Combined PO|Fostamatinib 100 mg BID (combined)
318553|NCT01197755|O1|Outcome|PLACEBO PO|Dosing Group C
318554|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
318555|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318556|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318557|NCT01197755|E3|Reported Event|PLACEBO PO|Dosing Group C
318558|NCT01197755|E2|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318559|NCT01197755|E1|Reported Event|FOSTA 100 MG BID PO|Dosing Group A
318560|NCT01197612|B1|Baseline|Single Arm; Nostrils as Experimental and Comparator|"each subject serves as their own control with one nostril being treated with pulmicort and one not~pulmicort: applied to nasal packing after surgery"
318561|NCT01197612|P1|Participant Flow|Single Arm; Nostrils as Experimental and Comparator|"each subject serves as their own control with one nostril being treated with pulmicort and one not~pulmicort: applied to nasal packing after surgery"
318562|NCT01197612|O2|Outcome|Untreated Nostril (no Pulmicort)|"each subject serves as their own control with one nostril being treated with pulmicort and one not~pulmicort: applied to nasal packing after surgery"
318563|NCT01197612|O1|Outcome|Treated Nostril (Pulmicort)|"each subject serves as their own control with one nostril being treated with pulmicort and one not~pulmicort: applied to nasal packing after surgery"
318564|NCT01197612|O2|Outcome|Placebo/Untreated Nostril (no Pulmicort)|"each subject serves as their own control with one nostril being treated with pulmicort and one not~pulmicort: applied to nasal packing after surgery"
318565|NCT01197612|O1|Outcome|Treated Nostril (Pulmicort)|"each subject serves as their own control with one nostril being treated with pulmicort and one not~pulmicort: applied to nasal packing after surgery"
318566|NCT01197612|O2|Outcome|Placebo Treated Nostril (no Pulmicort)|"each subject serves as their own control with one nostril being treated with pulmicort and one not~pulmicort: applied to nasal packing after surgery"
318567|NCT01197612|O1|Outcome|Treated Nostril (Pulmicort)|"each subject serves as their own control with one nostril being treated with pulmicort and one not~pulmicort: applied to nasal packing after surgery"
318568|NCT01197612|O2|Outcome|Untreated Nostril (no Pulmicort)|"each subject serves as their own control with one nostril being treated with pulmicort and one not~pulmicort: applied to nasal packing after surgery"
318569|NCT01197612|O1|Outcome|Treated Nostril (Pulmicort)|"each subject serves as their own control with one nostril being treated with pulmicort and one not~pulmicort: applied to nasal packing after surgery"
318570|NCT01197612|E1|Reported Event|Single Arm; Nostrils as Experimental and Comparator|"each subject serves as their own control with one nostril being treated with pulmicort and one not~pulmicort: applied to nasal packing after surgery"
318571|NCT01197560|B3|Baseline|Total|Total of all reporting groups
318572|NCT01197560|B2|Baseline|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
318573|NCT01197560|B1|Baseline|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
318574|NCT01197560|P2|Participant Flow|Investigator's Choice (Control Arm)|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the participant's request and at the investigators' discretion at the same doses mentioned."
318575|NCT01197560|P1|Participant Flow|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
318576|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
318604|NCT01197534|B4|Baseline|Total|Total of all reporting groups
318605|NCT01197534|B3|Baseline|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318606|NCT01197534|B2|Baseline|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318607|NCT01197534|B1|Baseline|FOSTA 100 MG BID PO|Dosing Group A
318577|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
318578|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
318579|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
318580|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
318581|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
318582|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
318583|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
318584|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
318585|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
318586|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
318587|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
318588|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
318589|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
318590|NCT01197560|O2|Outcome|Investigator's Choice|"Investigator’s Choice Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
318591|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
318592|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
318593|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
318594|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
318595|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
318596|NCT01197560|E2|Reported Event|Investigator's Choice|"One of the following:~Gemcitabine, Oxaliplatin, Rituximab, or Etoposide~Gemcitabine: Suggested starting doses and regimens for Gemcitabine are 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 every 28 days for 6 Cycles~Oxaliplatin: Suggested starting dose and regimen for Oxaliplatin is 100 mg/m^2 IV day 1 for 21 days for 6 Cycles~Rituximab: Suggested starting dose for Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide: Suggested starting doses for Etoposide are:~100 mg/m^2 IV days 1-5 every 28 days for 6 Cycles, or 100 mg/m^2 IV days 1-3 every 28 days for 6 Cycles, or 50 mg/m^2 oral days 1-21 every 28 days for 6 Cycles, or 50 mg/m^2 oral days 1-14 every 28 days for 6 Cycles, or 50 mg/m^2 oral days 1-10 every 28 days for 6 Cycles"
318597|NCT01197560|E1|Reported Event|Lenalidomide|Lenalidomide: Lenalidomide 25 mg orally for 21 out of every 28 day cycle until progressive disease. For participants with Creatinine Clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg (maximum dose was 15 mg lenalidomide).
318598|NCT01197547|B1|Baseline|Genesys HTA|"Genesys HTA Endometrial Ablation~Genesys HTA: Genesys HTA Endometrial Ablation"
318599|NCT01197547|P1|Participant Flow|Genesys HTA|Genesys HTA Endometrial Ablation
318600|NCT01197547|O1|Outcome|Genesys HTA|Genesys HTA Endometrial Ablation
318601|NCT01197547|O1|Outcome|Genesys HTA|Genesys HTA Endometrial Ablation
318602|NCT01197547|O1|Outcome|Genesys HTA|Genesys HTA Endometrial Ablation
318603|NCT01197547|E1|Reported Event|Genesys HTA|Genesys HTA Endometrial Ablation
318608|NCT01197534|P3|Participant Flow|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318609|NCT01197534|P2|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318610|NCT01197534|P1|Participant Flow|FOSTA 100 MG BID PO|Dosing Group A
318611|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318612|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318613|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318614|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318615|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318616|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318617|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318618|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318619|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318620|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318621|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318622|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318623|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318624|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318625|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318626|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318627|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318628|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318629|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318630|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318631|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318632|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318633|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318634|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318635|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318636|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318637|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318638|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318639|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318640|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318641|NCT01197534|O2|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318642|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO (Combined)|Dosing Group A and B combined
318643|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318644|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318645|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318646|NCT01197534|E4|Reported Event|PLACEBO (24 WKS) THEN FOSTA 100 MG BID - Placebo Period|
318647|NCT01197534|E3|Reported Event|PLACEBO (24 WKS) THEN FOSTA 100 MG BID - FOSTA Period|Dosing Group C
318648|NCT01197534|E2|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD|Dosing Group B
318649|NCT01197534|E1|Reported Event|FOSTA 100 MG BID|Dosing Group A
318650|NCT01197521|B4|Baseline|Total|Total of all reporting groups
318651|NCT01197521|B3|Baseline|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318652|NCT01197521|B2|Baseline|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318653|NCT01197521|B1|Baseline|FOSTA 100 MG BID PO|Dosing Group A
318654|NCT01197521|P3|Participant Flow|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318655|NCT01197521|P2|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318656|NCT01197521|P1|Participant Flow|FOSTA 100 MG BID PO|Dosing Group A
318657|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318658|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318659|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318660|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318661|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318662|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318663|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318664|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318665|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318666|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318667|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318668|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318669|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318670|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318671|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318672|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318673|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318674|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318675|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318676|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318677|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318678|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318679|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318680|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318681|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318682|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318683|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318684|NCT01197521|O2|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318685|NCT01197521|O1|Outcome|FOSTA 100 MG BID (Combined)|Dosing Group A and B combined
318686|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318687|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318688|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318689|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
318690|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
318691|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
318692|NCT01197521|E4|Reported Event|PLACEBO (24 WKS) THEN FOSTA 100 MG BID - Placebo Period|
318693|NCT01197521|E3|Reported Event|PLACEBO (24 WKS) THEN FOSTA 100 MG BID - FOSTA Period|Dosing Group C
318694|NCT01197521|E2|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD|Dosing Group B
318695|NCT01197521|E1|Reported Event|FOSTA 100 MG BID|Dosing Group A
318696|NCT01197508|B5|Baseline|Total|Total of all reporting groups
318697|NCT01197508|B4|Baseline|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
318698|NCT01197508|B3|Baseline|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
318699|NCT01197508|B2|Baseline|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
318700|NCT01197508|B1|Baseline|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
318701|NCT01197508|P4|Participant Flow|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
318702|NCT01197508|P3|Participant Flow|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
318703|NCT01197508|P2|Participant Flow|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
318704|NCT01197508|P1|Participant Flow|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
318705|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
318706|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
318707|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
318708|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
318709|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
318710|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
318711|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
318712|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
318713|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
318714|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
318715|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
318716|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
318717|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
318718|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
318719|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
318720|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
318721|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
318722|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
318723|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
318724|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
318725|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
318726|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
318727|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
318728|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
318729|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
320006|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
318730|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
318731|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
318732|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
318733|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
318734|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
318735|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
318736|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
318737|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
318738|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
318739|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
318740|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
318741|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
318742|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
318743|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
318744|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
318745|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
318746|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
318747|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
318748|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
318749|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
318750|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
318751|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
318752|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
318753|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
318754|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
318755|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
318756|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
318757|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
318758|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
318759|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
318760|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
318761|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
318762|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
318763|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
318764|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
318765|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
318766|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
318767|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
318768|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
318769|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
318770|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
318771|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
318772|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
318773|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
318774|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
318775|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
318776|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
318777|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
318778|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
318779|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
318780|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
318781|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
318782|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
318783|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
318784|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
318785|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
318786|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
318787|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
318788|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
318789|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
318790|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
318791|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
318792|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
318793|NCT01197508|E4|Reported Event|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
318794|NCT01197508|E3|Reported Event|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
318795|NCT01197508|E2|Reported Event|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
318796|NCT01197508|E1|Reported Event|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo
318797|NCT01197495|B3|Baseline|Total|Total of all reporting groups
318798|NCT01197495|B2|Baseline|Control|No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
318799|NCT01197495|B1|Baseline|Treatment|Juvederm(R) Ultra XC Injectable Gel
318800|NCT01197495|P2|Participant Flow|Control|No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
318801|NCT01197495|P1|Participant Flow|Treatment|Juvederm(R) Ultra XC Injectable Gel
318802|NCT01197495|O2|Outcome|Control|No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
318803|NCT01197495|O1|Outcome|Treatment|Juvederm(R) Ultra XC Injectable Gel
318804|NCT01197495|O1|Outcome|Treatment|Juvederm(R) Ultra XC Injectable Gel
318805|NCT01197495|O1|Outcome|Treatment|Juvederm(R) Ultra XC Injectable Gel
318806|NCT01197495|O1|Outcome|Treatment|Juvederm(R) Ultra XC Injectable Gel
318807|NCT01197495|O2|Outcome|Control|No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
318808|NCT01197495|O1|Outcome|Treatment|Juvederm(R) Ultra XC Injectable Gel
318809|NCT01197495|E2|Reported Event|Onset After Repeat Treatment|Juvederm(R) Ultra XC Injectable Gel
318810|NCT01197495|E1|Reported Event|Onset Prior to Repeat Treatment|Juvederm(R) Ultra XC Injectable Gel
318811|NCT01197417|B3|Baseline|Total|Total of all reporting groups
318812|NCT01197417|B2|Baseline|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
318813|NCT01197417|B1|Baseline|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
318814|NCT01197417|P2|Participant Flow|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
318815|NCT01197417|P1|Participant Flow|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
318816|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
318817|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
320007|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
318818|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
318819|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
318820|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
318821|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
318822|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
318823|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
318824|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
318825|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
318826|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
318827|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
318828|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
318829|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
318830|NCT01197417|E2|Reported Event|Placebo Group|Normal Saline placebo Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses
318831|NCT01197417|E1|Reported Event|Magnesium Group|Intravenous Magnesium Sulfate Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses
318832|NCT01197326|B3|Baseline|Total|Total of all reporting groups
318833|NCT01197326|B2|Baseline|Group 2|"Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor.~Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
318834|NCT01197326|B1|Baseline|Group 1|"Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.~Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
318835|NCT01197326|P2|Participant Flow|Group 2|"Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor.~Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
318836|NCT01197326|P1|Participant Flow|Group 1|"Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.~Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
318837|NCT01197326|O2|Outcome|Group 2|"Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor.~use of the MP5 EWS patient monitor: All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
318838|NCT01197326|O1|Outcome|Group 1|"Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.~use of the MP5 EWS patient monitor: All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
318839|NCT01197326|O2|Outcome|Group 2|"Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor.~Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
318840|NCT01197326|O1|Outcome|Group 1|"Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.~Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
318841|NCT01197326|E2|Reported Event|Patients Who Triggered MET/RRT Calls After the Use of MP5|Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor
318842|NCT01197326|E1|Reported Event|Patients Who Triggered MET/RRT Calls Prior to the Use of MP5|Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor
318843|NCT01196988|B5|Baseline|Total|Total of all reporting groups
318844|NCT01196988|B4|Baseline|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
319180|NCT01196104|P2|Participant Flow|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
318845|NCT01196988|B3|Baseline|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318846|NCT01196988|B2|Baseline|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318847|NCT01196988|B1|Baseline|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318848|NCT01196988|P4|Participant Flow|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318849|NCT01196988|P3|Participant Flow|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318850|NCT01196988|P2|Participant Flow|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318851|NCT01196988|P1|Participant Flow|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318852|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318853|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318854|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318855|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318856|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318857|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318858|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318859|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318860|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318861|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318862|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318863|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318864|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318865|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318866|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318867|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318868|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318869|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318870|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318871|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318872|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318873|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318874|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318875|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318876|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318877|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318878|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318879|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318880|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318881|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318882|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318883|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318884|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318885|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318886|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318887|NCT01196988|O1|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318888|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318889|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318890|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318891|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318892|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318893|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318894|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318895|NCT01196988|O1|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318896|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318897|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318898|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318899|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318900|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318901|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318902|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318903|NCT01196988|O1|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318904|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318905|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318906|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318907|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318908|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318909|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318910|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318911|NCT01196988|O1|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318912|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318913|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318914|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318915|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318916|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318917|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318918|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318919|NCT01196988|O1|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318920|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318921|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318922|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318923|NCT01196988|O1|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318924|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318925|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318926|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318927|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318928|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318929|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318930|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318931|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318932|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318933|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318934|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318935|NCT01196988|E4|Reported Event|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318936|NCT01196988|E3|Reported Event|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318937|NCT01196988|E2|Reported Event|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318938|NCT01196988|E1|Reported Event|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
318939|NCT01196975|B6|Baseline|Total|Total of all reporting groups
318940|NCT01196975|B5|Baseline|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318941|NCT01196975|B4|Baseline|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318942|NCT01196975|B3|Baseline|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318943|NCT01196975|B2|Baseline|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318944|NCT01196975|B1|Baseline|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
318945|NCT01196975|P5|Participant Flow|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318946|NCT01196975|P4|Participant Flow|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318947|NCT01196975|P3|Participant Flow|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318948|NCT01196975|P2|Participant Flow|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318949|NCT01196975|P1|Participant Flow|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318950|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318951|NCT01196975|O4|Outcome|Victoria Strain FluLaval|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318952|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318953|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318954|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318955|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318956|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318957|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318958|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318959|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318960|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318961|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318962|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318963|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318964|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318965|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318966|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318967|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318968|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318969|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318970|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318971|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318972|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318973|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318974|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318975|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318976|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318977|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318978|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318979|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318980|NCT01196975|O3|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318981|NCT01196975|O2|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318982|NCT01196975|O1|Outcome|GSK2282512A Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318983|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
318984|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318985|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318986|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318987|NCT01196975|O2|Outcome|GSK2282512A ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318988|NCT01196975|O1|Outcome|GSK2282512A 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318989|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318990|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318991|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318992|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318993|NCT01196975|O2|Outcome|GSK2282512A ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318994|NCT01196975|O1|Outcome|GSK2282512A 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318995|NCT01196975|O3|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318996|NCT01196975|O2|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319214|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
318997|NCT01196975|O1|Outcome|GSK2282512A Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318998|NCT01196975|O3|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
318999|NCT01196975|O2|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319000|NCT01196975|O1|Outcome|GSK2282512A Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319001|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
319002|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319003|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319004|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319005|NCT01196975|O2|Outcome|GSK2282512A ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319006|NCT01196975|O1|Outcome|GSK2282512A 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319007|NCT01196975|O3|Outcome|Yamagata Strain FluLaval Group|Yamagata Strain FluLaval Group - Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319008|NCT01196975|O2|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319009|NCT01196975|O1|Outcome|GSK2282512A Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319010|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
319011|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319012|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319013|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319014|NCT01196975|O2|Outcome|GSK2282512A ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319015|NCT01196975|O1|Outcome|GSK2282512A 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319016|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319017|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319018|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319019|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319020|NCT01196975|O2|Outcome|GSK2282512A ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319021|NCT01196975|O1|Outcome|GSK2282512A 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319022|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319023|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319024|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319025|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319026|NCT01196975|O2|Outcome|GSK2282512A ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319027|NCT01196975|O1|Outcome|GSK2282512A 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319028|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319029|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319030|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319031|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319032|NCT01196975|O2|Outcome|GSK2282512A ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319033|NCT01196975|O1|Outcome|GSK2282512A 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319034|NCT01196975|O3|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
319035|NCT01196975|O2|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319036|NCT01196975|O1|Outcome|GSK2282512A Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319037|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319038|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319039|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319040|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319041|NCT01196975|O2|Outcome|GSK2282512A ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319042|NCT01196975|O1|Outcome|GSK2282512A 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319043|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
320008|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
319044|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319045|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
319046|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319047|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319048|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319049|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
319050|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
319051|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319052|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319053|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319054|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319055|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319056|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319057|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319058|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319059|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319060|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319061|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319062|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319063|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319064|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319065|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319066|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319067|NCT01196975|O2|Outcome|GSK2282512A ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319068|NCT01196975|O1|Outcome|GSK2282512A 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319069|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319070|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319071|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319072|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319073|NCT01196975|O2|Outcome|GSK2282512A ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319074|NCT01196975|O1|Outcome|GSK2282512A 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319075|NCT01196975|E5|Reported Event|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319076|NCT01196975|E4|Reported Event|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319077|NCT01196975|E3|Reported Event|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319078|NCT01196975|E2|Reported Event|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
319079|NCT01196975|E1|Reported Event|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.dominant arm.
319080|NCT01196923|B1|Baseline|HeartLight Ablation|Pulmonary Vein Isolation with the HeartLight System. Participants with data available are reported so that not all measures may include data from 20 participants.
319081|NCT01196923|P1|Participant Flow|HeartLight Ablation|Pulmonary Vein Isolation with the HeartLight System
319082|NCT01196923|O1|Outcome|HeartLight Acutely Isolated Pulmonary Veins|
319083|NCT01196923|E1|Reported Event|HeartLight Ablation|Pulmonary Vein Isolation with the HeartLight System
319084|NCT01196819|B3|Baseline|Total|Total of all reporting groups
319085|NCT01196819|B2|Baseline|MicroPort Firehawk DES|"Use MicroPort's new generation of Firehawk drug eluting stent~DES implantation: Implant DES for CAD cases"
319086|NCT01196819|B1|Baseline|Xience V DES as Comparative Arm|"Use Xience V DES as control group~DES implantation: Implant DES for CAD cases"
319087|NCT01196819|P2|Participant Flow|MicroPort Firehawk DES|"Use MicroPort's new generation of Firehawk drug eluting stent~DES implantation: Implant DES for CAD cases"
319088|NCT01196819|P1|Participant Flow|Xience V DES as Comparative Arm|"Use Xience V DES as control group~DES implantation: Implant DES for CAD cases"
319089|NCT01196819|O2|Outcome|MicroPort Firehawk DES|"Use MicroPort's new generation of Firehawk drug eluting stent~DES implantation: Implant DES for CAD cases"
319090|NCT01196819|O1|Outcome|Xience V DES as Comparative Arm|"Use Xience V DES as control group~DES implantation: Implant DES for CAD cases"
319091|NCT01196819|O2|Outcome|MicroPort Firehawk DES|"Use MicroPort's new generation of Firehawk drug eluting stent~DES implantation: Implant DES for CAD cases"
319092|NCT01196819|O1|Outcome|Xience V DES as Comparative Arm|"Use Xience V DES as control group~DES implantation: Implant DES for CAD cases"
319093|NCT01196819|O2|Outcome|MicroPort Firehawk DES|"Use MicroPort's new generation of Firehawk drug eluting stent~DES implantation: Implant DES for CAD cases"
319094|NCT01196819|O1|Outcome|Xience V DES as Comparative Arm|"Use Xience V DES as control group~DES implantation: Implant DES for CAD cases"
319095|NCT01196819|O2|Outcome|MicroPort Firehawk DES|"Use MicroPort's new generation of Firehawk drug eluting stent~DES implantation: Implant DES for CAD cases"
319096|NCT01196819|O1|Outcome|Xience V DES as Comparative Arm|"Use Xience V DES as control group~DES implantation: Implant DES for CAD cases"
319097|NCT01196819|O2|Outcome|MicroPort Firehawk DES|"Use MicroPort's new generation of Firehawk drug eluting stent~DES implantation: Implant DES for CAD cases"
319098|NCT01196819|O1|Outcome|Xience V DES as Comparative Arm|"Use Xience V DES as control group~DES implantation: Implant DES for CAD cases"
319099|NCT01196819|O2|Outcome|MicroPort Firehawk DES|"Use MicroPort's new generation of Firehawk drug eluting stent~DES implantation: Implant DES for CAD cases"
319100|NCT01196819|O1|Outcome|Xience V DES as Comparative Arm|"Use Xience V DES as control group~DES implantation: Implant DES for CAD cases"
319101|NCT01196819|O2|Outcome|MicroPort Firehawk DES|"Use MicroPort's new generation of Firehawk drug eluting stent~DES implantation: Implant DES for CAD cases"
319102|NCT01196819|O1|Outcome|Xience V DES as Comparative Arm|"Use Xience V DES as control group~DES implantation: Implant DES for CAD cases"
319103|NCT01196819|O2|Outcome|MicroPort Firehawk DES|"Use MicroPort's new generation of Firehawk drug eluting stent~DES implantation: Implant DES for CAD cases"
319104|NCT01196819|O1|Outcome|Xience V DES as Comparative Arm|"Use Xience V DES as control group~DES implantation: Implant DES for CAD cases"
319105|NCT01196819|E2|Reported Event|MicroPort Firehawk DES|"Use MicroPort's new generation of Firehawk drug eluting stent~DES implantation: Implant DES for CAD cases"
319106|NCT01196819|E1|Reported Event|Xience V DES as Comparative Arm|"Use Xience V DES as control group~DES implantation: Implant DES for CAD cases"
319107|NCT01196741|B3|Baseline|Total|Total of all reporting groups
319136|NCT01196429|B1|Baseline|US/Korea|Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
320009|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
319108|NCT01196741|B2|Baseline|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
319109|NCT01196741|B1|Baseline|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
319110|NCT01196741|P2|Participant Flow|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
319111|NCT01196741|P1|Participant Flow|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
319112|NCT01196741|O2|Outcome|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
319113|NCT01196741|O1|Outcome|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
319114|NCT01196741|O2|Outcome|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
319115|NCT01196741|O1|Outcome|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
319116|NCT01196741|O2|Outcome|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
319117|NCT01196741|O1|Outcome|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
319118|NCT01196741|O2|Outcome|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
319137|NCT01196429|P2|Participant Flow|Japan|Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
319272|NCT01196026|P3|Participant Flow|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319119|NCT01196741|O1|Outcome|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
319120|NCT01196741|O2|Outcome|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
319121|NCT01196741|O1|Outcome|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
319122|NCT01196741|E2|Reported Event|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
319123|NCT01196741|E1|Reported Event|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
319124|NCT01196442|B1|Baseline|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
319125|NCT01196442|P1|Participant Flow|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
319126|NCT01196442|O1|Outcome|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
319127|NCT01196442|O1|Outcome|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
319128|NCT01196442|O1|Outcome|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
319129|NCT01196442|O1|Outcome|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
319130|NCT01196442|O1|Outcome|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
319131|NCT01196442|O1|Outcome|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
319132|NCT01196442|O1|Outcome|Arm I|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~Electrical stimulation pain therapy: Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~Questionnaire administration: Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
319133|NCT01196442|E1|Reported Event|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
319134|NCT01196429|B3|Baseline|Total|Total of all reporting groups
319135|NCT01196429|B2|Baseline|Japan|Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
319138|NCT01196429|P1|Participant Flow|US/Korea|Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
319139|NCT01196429|O2|Outcome|Japan|Patients enrolled from Japan
319140|NCT01196429|O1|Outcome|US/Korea|Patients enrolled from the U.S.and Korea
319141|NCT01196429|O2|Outcome|Japan|Patients enrolled from Japan
319142|NCT01196429|O1|Outcome|US/Korea|Patients enrolled from the U.S.and Korea
319143|NCT01196429|O2|Outcome|Japan|Patients enrolled from Japan
319144|NCT01196429|O1|Outcome|US/Korea|Patients enrolled from the U.S.and Korea
319145|NCT01196429|O2|Outcome|Japan|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
319146|NCT01196429|O1|Outcome|US/Korea|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
319147|NCT01196429|O2|Outcome|Japan|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
319148|NCT01196429|O1|Outcome|US/Korea|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
319149|NCT01196429|O2|Outcome|Japan|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
319150|NCT01196429|O1|Outcome|US/Korea|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
319151|NCT01196429|E2|Reported Event|Japan|Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
319152|NCT01196429|E1|Reported Event|US/Korea|Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
319153|NCT01196416|B1|Baseline|Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide)|Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097, vinblastine and temozolomide
319154|NCT01196416|P1|Participant Flow|Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide)|Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097, vinblastine and temozolomide
319155|NCT01196416|O1|Outcome|Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide)|Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097, vinblastine and temozolomide
319156|NCT01196416|O1|Outcome|Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide)|Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097, vinblastine and temozolomide
319157|NCT01196416|O1|Outcome|Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide)|Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097, vinblastine and temozolomide
319158|NCT01196416|O1|Outcome|Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide)|Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097, vinblastine and temozolomide
319159|NCT01196416|E1|Reported Event|Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide)|Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097, vinblastine and temozolomide
319160|NCT01196377|B5|Baseline|Total|Total of all reporting groups
319161|NCT01196377|B4|Baseline|25mg/hr Pulsed|Experimental 25mg/hr pulsed
319162|NCT01196377|B3|Baseline|25mg/hr Continuous|Experimental 25mg/hr continuous albuterol.
319163|NCT01196377|B2|Baseline|10mg/hr Pulsed|Experimental 10mg/hr pulsed albuterol regimen.
319164|NCT01196377|B1|Baseline|Nebulized Albuterol 10mg/hr Continuous|Active control arm, 10mg/hr continuous.
319165|NCT01196377|P4|Participant Flow|25mg/hr Pulsed|Experimental 25mg/hr pulsed
319166|NCT01196377|P3|Participant Flow|25mg/hr Continuous|Experimental 25mg/hr continuous albuterol.
319167|NCT01196377|P2|Participant Flow|10mg/hr Pulsed|Experimental 10mg/hr pulsed albuterol regimen.
319168|NCT01196377|P1|Participant Flow|Nebulized Albuterol 10mg/hr Continuous|Active control arm, 10mg/hr continuous.
319169|NCT01196377|O4|Outcome|25mg/hr Pulsed|"Experimental 25mg/hr pulsed~Albuterol: Nebulized albuterol"
319170|NCT01196377|O3|Outcome|25mg/hr Continuous|"Experimental 25mg/hr continuous albuterol.~Albuterol: Nebulized albuterol"
319171|NCT01196377|O2|Outcome|10mg/hr Pulsed|"Experimental 10mg/hr pulsed albuterol regimen.~Albuterol: Nebulized albuterol"
319172|NCT01196377|O1|Outcome|Nebulized Albuterol 10mg/hr Continuous|"Active control arm, 10mg/hr continuous.~Albuterol: Nebulized albuterol"
319173|NCT01196377|E4|Reported Event|25mg/hr Pulsed|Experimental 25mg/hr pulsed
319174|NCT01196377|E3|Reported Event|25mg/hr Continuous|Experimental 25mg/hr continuous albuterol.
319175|NCT01196377|E2|Reported Event|10mg/hr Pulsed|Experimental 10mg/hr pulsed albuterol regimen.
319176|NCT01196377|E1|Reported Event|Nebulized Albuterol 10mg/hr Continuous|Active control arm, 10mg/hr continuous.
319177|NCT01196104|B3|Baseline|Total|Total of all reporting groups
319178|NCT01196104|B2|Baseline|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
319179|NCT01196104|B1|Baseline|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
319181|NCT01196104|P1|Participant Flow|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
319182|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
319183|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
319184|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
319185|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
319186|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
319187|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
319188|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
319189|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
319190|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
319191|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
319192|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
319193|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
319194|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
319195|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
319196|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
319197|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
319198|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
319199|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
319200|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
319201|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
319202|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
319203|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
319204|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
319205|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
319206|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
319207|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
319208|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
319209|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
319210|NCT01196104|O2|Outcome|Comparator|"Insulin Glargine and Insulin Aspart~Insulin Aspart: Usual Care~Insulin Glargine"
319211|NCT01196104|O1|Outcome|Technosphere® Insulin Inhalation Powder (TI)|"Insulin Glargine and Technosphere® Insulin Inhalation Powder~Technosphere® Insulin Inhalation Powder~Insulin Glargine"
319212|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
319213|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
320010|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
319215|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
319216|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
319217|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
319218|NCT01196104|E2|Reported Event|Comparator|"Insulin Glargine and Insulin Aspart~Insulin Aspart: Usual Care~Insulin Glargine"
319219|NCT01196104|E1|Reported Event|Technosphere® Insulin Inhalation Powder (TI)|"Insulin Glargine and Technosphere® Insulin Inhalation Powder~Technosphere® Insulin Inhalation Powder~Insulin Glargine"
319220|NCT01196078|B3|Baseline|Total|Total of all reporting groups
319221|NCT01196078|B2|Baseline|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
319222|NCT01196078|B1|Baseline|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
319223|NCT01196078|P2|Participant Flow|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 milligrams per square meter (mg/m^2) orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 adverse events [AEs]) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
319224|NCT01196078|P1|Participant Flow|Erlotinib|Participants received erlotinib 150 milligrams (mg), tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
319225|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
319226|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
319227|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
319228|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
319229|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
319230|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
319231|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
319232|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
319233|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
319234|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
319235|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
319236|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
319237|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
319238|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
319239|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
319240|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
319241|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
319242|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
319243|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
319244|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
319245|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
319246|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
319247|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
319248|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
319249|NCT01196078|E2|Reported Event|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
319250|NCT01196078|E1|Reported Event|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
319251|NCT01196052|B1|Baseline|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
319252|NCT01196052|P1|Participant Flow|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
319253|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
319254|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
319255|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
319256|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
319257|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
319258|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
319259|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
319260|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
319261|NCT01196052|E1|Reported Event|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
319262|NCT01196026|B7|Baseline|Total|Total of all reporting groups
319263|NCT01196026|B6|Baseline|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319264|NCT01196026|B5|Baseline|Havrix Junior 12-35 Months Group|Subjects aged 12-35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix Junior vaccine.
319265|NCT01196026|B4|Baseline|Havrix Junior 6-11 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319266|NCT01196026|B3|Baseline|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319267|NCT01196026|B2|Baseline|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319268|NCT01196026|B1|Baseline|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319269|NCT01196026|P6|Participant Flow|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319270|NCT01196026|P5|Participant Flow|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319271|NCT01196026|P4|Participant Flow|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
320011|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
319273|NCT01196026|P2|Participant Flow|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319274|NCT01196026|P1|Participant Flow|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319275|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319276|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319277|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319278|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319279|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319280|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319281|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319282|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319283|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319284|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319285|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319286|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319287|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319288|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319289|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319290|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319291|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319292|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319293|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319294|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319295|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319296|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319297|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319298|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319299|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319300|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319301|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319302|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319303|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319304|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319305|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
320012|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
319306|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319307|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319308|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319309|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319310|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319311|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319312|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319313|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319314|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319315|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319316|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319317|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319318|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319319|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319320|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319321|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319322|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319323|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319324|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319325|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319326|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319327|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319328|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319329|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319330|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319331|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319332|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319333|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319334|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319335|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
319336|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
319337|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319338|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319339|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319340|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319341|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319342|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319343|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
319344|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
319345|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319346|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319347|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319348|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319349|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319350|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319351|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
319352|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
319353|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319354|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319355|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319356|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319357|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319358|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319359|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
319360|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
319361|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319362|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319363|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319364|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319365|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319366|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319367|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
319368|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
319369|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319370|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319371|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319372|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319545|NCT01195844|O1|Outcome|Children Hospitalized For Diarrhea|Children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers
319373|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319374|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319375|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
319376|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
319377|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319378|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319379|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319380|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319381|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319382|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319383|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
319384|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
319385|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319386|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319387|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319388|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319389|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319390|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319391|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
319392|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
319393|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319394|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319395|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319396|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319397|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319398|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319399|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
319400|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
319401|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319402|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319403|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319404|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319405|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319546|NCT01195844|O1|Outcome|Children Hospitalized For Diarrhea|Children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers
319406|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319407|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
319408|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
319409|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319410|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319411|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319412|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319413|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319414|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319415|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
319416|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
319417|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319418|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319419|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319420|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319421|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319422|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319423|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
319424|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
319425|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319426|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319427|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319428|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319429|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319430|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319431|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
319432|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
319433|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319434|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319435|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319436|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319437|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319438|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319439|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
319440|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
319441|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319442|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319443|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319444|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319445|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319446|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319447|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
319448|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
319449|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319450|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319451|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319452|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319453|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319454|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319455|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
319456|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
319457|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319458|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319459|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319460|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319461|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319462|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319463|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
319464|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319465|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319466|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319467|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319468|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319469|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319470|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
319471|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319472|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319473|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319474|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319475|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319476|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319477|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
319478|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319479|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319480|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319481|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319482|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319483|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319484|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
319485|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319486|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319487|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319488|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319489|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319490|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319491|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
319492|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319493|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319494|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319495|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319496|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319497|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319498|NCT01196026|E8|Reported Event|Havrix Junior Group|Subjects received 1 dose of Havrix Junior vacine. The second dose was administered outside the study setting.
319499|NCT01196026|E7|Reported Event|Fluarix Group|subjects received 1 or doses of Fluarix vaccine based on age and priming status
319500|NCT01196026|E6|Reported Event|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319501|NCT01196026|E5|Reported Event|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319502|NCT01196026|E4|Reported Event|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
319503|NCT01196026|E3|Reported Event|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319504|NCT01196026|E2|Reported Event|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319505|NCT01196026|E1|Reported Event|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
319506|NCT01195948|B4|Baseline|Total|Total of all reporting groups
319507|NCT01195948|B3|Baseline|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
319508|NCT01195948|B2|Baseline|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
319509|NCT01195948|B1|Baseline|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
319510|NCT01195948|P3|Participant Flow|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
319511|NCT01195948|P2|Participant Flow|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
319512|NCT01195948|P1|Participant Flow|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
319513|NCT01195948|O3|Outcome|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
319514|NCT01195948|O2|Outcome|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
319515|NCT01195948|O1|Outcome|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
319516|NCT01195948|O3|Outcome|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
319517|NCT01195948|O2|Outcome|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
319518|NCT01195948|O1|Outcome|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
319519|NCT01195948|O3|Outcome|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
319520|NCT01195948|O2|Outcome|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
319521|NCT01195948|O1|Outcome|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
319522|NCT01195948|O3|Outcome|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
319523|NCT01195948|O2|Outcome|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
319524|NCT01195948|O1|Outcome|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
319525|NCT01195948|O3|Outcome|Placebo|"Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~Placebo: Capsule with no active ingredients to mimic B27PD"
319526|NCT01195948|O2|Outcome|B27PD 4 mg|"Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
319527|NCT01195948|O1|Outcome|B27PD 1 mg|"Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
319528|NCT01195948|O3|Outcome|Placebo|"Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~Placebo: Capsule with no active ingredients to mimic B27PD"
319529|NCT01195948|O2|Outcome|B27PD 4 mg|"Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
319530|NCT01195948|O1|Outcome|B27PD 1 mg|"Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
319590|NCT01195779|P14|Participant Flow|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
319531|NCT01195948|O3|Outcome|Placebo|"Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~Placebo: Capsule with no active ingredients to mimic B27PD"
319532|NCT01195948|O2|Outcome|B27PD 4 mg|"Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
319533|NCT01195948|O1|Outcome|B27PD 1 mg|"Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
319534|NCT01195948|E3|Reported Event|Placebo|"Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~Placebo: Capsule with no active ingredients to mimic B27PD"
319535|NCT01195948|E2|Reported Event|B27PD 4 mg|"Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
319536|NCT01195948|E1|Reported Event|B27PD 1 mg|"Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
319537|NCT01195922|B1|Baseline|Sirolimus|Rapamycin (sirolimus), which will be dispensed as either tablets or an oral solution for patients with dysphagia (see Section 0), will be administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Serum rapamycin levels will be obtained on Days 8, 15, 22, and 28 (if rapamycin is > 3 ng/ml at Day 28, the subject will return daily, or as is convenient, for testing until rapamycin is ≤ 3 ng/ml). Dose reduction to 3 mg by mouth once per day will occur if trough levels of rapamycin > 20 ng/ml occur on Days 8 or 15 (see Appendix A, Study Calendar for visit windows). If a dose is decreased at Day 8, it will not be increased at Day 15 regardless of serum rapamycin levels. If subjects receiving 3 mg have levels > 20 ng/ml at Day 15, rapamycin will be reduced to 2 mg once per day. Rapamycin will cease on Day 21 regardless of level.
319538|NCT01195922|P1|Participant Flow|Sirolimus|Rapamycin (sirolimus), dispensed as either tablets or an oral solution for patients with dysphagia was administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Dose reductions to 3 mg by mouth once per day were implemented if levels of rapamycin > 20 ng/ml occurred on Days 8 or 15.
319539|NCT01195922|O1|Outcome|Sirolimus|Rapamycin (sirolimus), which will be dispensed as either tablets or an oral solution for patients with dysphagia (see Section 0), will be administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Serum rapamycin levels will be obtained on Days 8, 15, 22, and 28 (if rapamycin is > 3 ng/ml at Day 28, the subject will return daily, or as is convenient, for testing until rapamycin is ≤ 3 ng/ml). Dose reduction to 3 mg by mouth once per day will occur if trough levels of rapamycin > 20 ng/ml occur on Days 8 or 15 (see Appendix A, Study Calendar for visit windows). If a dose is decreased at Day 8, it will not be increased at Day 15 regardless of serum rapamycin levels. If subjects receiving 3 mg have levels > 20 ng/ml at Day 15, rapamycin will be reduced to 2 mg once per day. Rapamycin will cease on Day 21 regardless of level.
319540|NCT01195922|O1|Outcome|Sirolimus|Rapamycin (sirolimus), which will be dispensed as either tablets or an oral solution for patients with dysphagia (see Section 0), will be administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Serum rapamycin levels will be obtained on Days 8, 15, 22, and 28 (if rapamycin is > 3 ng/ml at Day 28, the subject will return daily, or as is convenient, for testing until rapamycin is ≤ 3 ng/ml). Dose reduction to 3 mg by mouth once per day will occur if trough levels of rapamycin > 20 ng/ml occur on Days 8 or 15 (see Appendix A, Study Calendar for visit windows). If a dose is decreased at Day 8, it will not be increased at Day 15 regardless of serum rapamycin levels. If subjects receiving 3 mg have levels > 20 ng/ml at Day 15, rapamycin will be reduced to 2 mg once per day. Rapamycin will cease on Day 21 regardless of level.
319541|NCT01195922|O1|Outcome|Sirolimus|Rapamycin (sirolimus), which will be dispensed as either tablets or an oral solution for patients with dysphagia (see Section 0), will be administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Serum rapamycin levels will be obtained on Days 8, 15, 22, and 28 (if rapamycin is > 3 ng/ml at Day 28, the subject will return daily, or as is convenient, for testing until rapamycin is ≤ 3 ng/ml). Dose reduction to 3 mg by mouth once per day will occur if trough levels of rapamycin > 20 ng/ml occur on Days 8 or 15 (see Appendix A, Study Calendar for visit windows). If a dose is decreased at Day 8, it will not be increased at Day 15 regardless of serum rapamycin levels. If subjects receiving 3 mg have levels > 20 ng/ml at Day 15, rapamycin will be reduced to 2 mg once per day. Rapamycin will cease on Day 21 regardless of level.
319542|NCT01195922|E1|Reported Event|Sirolimus|Rapamycin (sirolimus), which will be dispensed as either tablets or an oral solution for patients with dysphagia (see Section 0), will be administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Serum rapamycin levels will be obtained on Days 8, 15, 22, and 28 (if rapamycin is > 3 ng/ml at Day 28, the subject will return daily, or as is convenient, for testing until rapamycin is ≤ 3 ng/ml). Dose reduction to 3 mg by mouth once per day will occur if trough levels of rapamycin > 20 ng/ml occur on Days 8 or 15 (see Appendix A, Study Calendar for visit windows). If a dose is decreased at Day 8, it will not be increased at Day 15 regardless of serum rapamycin levels. If subjects receiving 3 mg have levels > 20 ng/ml at Day 15, rapamycin will be reduced to 2 mg once per day. Rapamycin will cease on Day 21 regardless of level.
319543|NCT01195844|B1|Baseline|Children Who Provided a Fecal Sample|Children up to 5 years of age hospitalized for diarrhea and providing a fecal sample in the 4 Brazilian hospital research centers. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.
319544|NCT01195844|P1|Participant Flow|Children Hospitalized For Diarrhea|Children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers
320013|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
319547|NCT01195844|O2|Outcome|Total Number Diagnosed With Rotavirus Diarrhea|Children up to 5 years of age diagnosed with rotavirus diarrhea in the 4 Brazilian hospital research centers
319548|NCT01195844|O1|Outcome|Total Number Hospitalized For Diarrhea of Any Cause|Total number of children up to 5 years of age hospitalized for diarrhea of any cause in the 4 Brazilian hospital research centers
319549|NCT01195844|O1|Outcome|Children Hospitalized For Rotavirus-Positive Diarrhea|Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the 4 Brazilian hospital research centers
319550|NCT01195844|O1|Outcome|Children Hospitalized For Diarrhea Who Provided a Fecal Sample|Children up to 5 years of age hospitalized for diarrhea and providing a fecal sample in the 4 Brazilian hospital research centers
319551|NCT01195844|O4|Outcome|São Paulo (Southeast)|Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the São Paulo (Southeast Brazil) hospital research center
319552|NCT01195844|O3|Outcome|Porto Alegre (South)|Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Porto Alegre (South Brazil) hospital research center
319553|NCT01195844|O2|Outcome|Goiânia (Center-West)|Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Goiânia (Center-West Brazil) hospital research center
319554|NCT01195844|O1|Outcome|Salvador (Northeast)|Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Salvador (Northeast Brazil) hospital research center
319555|NCT01195844|O1|Outcome|Children Hospitalized for Diarrhea|Children hospitalized for diarrhea in the 4 Brazilian hospital research centers
319556|NCT01195844|O1|Outcome|Children Hospitalized For Diarrhea|Children hospitalized for diarrhea in the 4 Brazilian hospital research centers
319557|NCT01195844|E1|Reported Event|Children Hospitalized For Diarrhea|Children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers
319558|NCT01195831|B3|Baseline|Total|Total of all reporting groups
319559|NCT01195831|B2|Baseline|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
319560|NCT01195831|B1|Baseline|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
319561|NCT01195831|P2|Participant Flow|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
319562|NCT01195831|P1|Participant Flow|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
319563|NCT01195831|O2|Outcome|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
319564|NCT01195831|O1|Outcome|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
319565|NCT01195831|O2|Outcome|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
319566|NCT01195831|O1|Outcome|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
319567|NCT01195831|O2|Outcome|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
319568|NCT01195831|O1|Outcome|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
319569|NCT01195831|O2|Outcome|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
319570|NCT01195831|O1|Outcome|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
319571|NCT01195831|O2|Outcome|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
319572|NCT01195831|O1|Outcome|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
319573|NCT01195831|E2|Reported Event|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
319574|NCT01195831|E1|Reported Event|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
319575|NCT01195779|B15|Baseline|Total|Total of all reporting groups
319576|NCT01195779|B14|Baseline|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
319577|NCT01195779|B13|Baseline|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
319578|NCT01195779|B12|Baseline|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319579|NCT01195779|B11|Baseline|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319580|NCT01195779|B10|Baseline|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319581|NCT01195779|B9|Baseline|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319582|NCT01195779|B8|Baseline|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319583|NCT01195779|B7|Baseline|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319584|NCT01195779|B6|Baseline|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319585|NCT01195779|B5|Baseline|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319586|NCT01195779|B4|Baseline|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319587|NCT01195779|B3|Baseline|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319588|NCT01195779|B2|Baseline|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319589|NCT01195779|B1|Baseline|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319591|NCT01195779|P13|Participant Flow|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
319592|NCT01195779|P12|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319593|NCT01195779|P11|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319594|NCT01195779|P10|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319595|NCT01195779|P9|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319596|NCT01195779|P8|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319597|NCT01195779|P7|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319598|NCT01195779|P6|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319599|NCT01195779|P5|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319600|NCT01195779|P4|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319601|NCT01195779|P3|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319602|NCT01195779|P2|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319603|NCT01195779|P1|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319604|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
319605|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
319606|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319607|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319608|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319609|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319610|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319611|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319612|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319613|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319614|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319615|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319616|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319617|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319618|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
319619|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
319620|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319621|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319622|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319623|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319624|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319625|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319626|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319627|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319628|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319629|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319630|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319631|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319632|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
319633|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
319634|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319635|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319636|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319637|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319638|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319639|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319640|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319641|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319642|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319643|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319644|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319645|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319646|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
319647|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
319648|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319649|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319650|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319651|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319652|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319653|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319654|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319655|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319656|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319657|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319658|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
320014|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
319659|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319660|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
319661|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
319662|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319663|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319664|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319665|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319666|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319667|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319668|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319669|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319670|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319671|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319672|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319673|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319674|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
319675|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
319676|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319677|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319678|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319679|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319680|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319681|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319682|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319683|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319684|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319685|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319686|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319687|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319688|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
319689|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
319690|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319691|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319692|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319693|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
320015|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
319694|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319695|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319696|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319697|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319698|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319699|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319700|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319701|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319702|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
319703|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
319704|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319705|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319706|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319707|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319708|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319709|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319710|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319711|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319712|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319713|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319714|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319715|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319716|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
319717|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
319718|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319719|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319720|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319721|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319722|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319723|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319724|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319725|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319726|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319727|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
320016|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
319728|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319729|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319730|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
319731|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
319732|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319733|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319734|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319735|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319736|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319737|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319738|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319739|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319740|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319741|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319742|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319743|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319744|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
319745|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
319746|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319747|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319748|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319749|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319750|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319751|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319752|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319753|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319754|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319755|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319756|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319757|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319758|NCT01195779|E14|Reported Event|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
319759|NCT01195779|E13|Reported Event|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
319760|NCT01195779|E12|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319761|NCT01195779|E11|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
319762|NCT01195779|E10|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319763|NCT01195779|E9|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
319764|NCT01195779|E8|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319765|NCT01195779|E7|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
319766|NCT01195779|E6|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319767|NCT01195779|E5|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
319768|NCT01195779|E4|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319769|NCT01195779|E3|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
319770|NCT01195779|E2|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319771|NCT01195779|E1|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
319772|NCT01195701|B3|Baseline|Total|Total of all reporting groups
319773|NCT01195701|B2|Baseline|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
319774|NCT01195701|B1|Baseline|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
319775|NCT01195701|P2|Participant Flow|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
319776|NCT01195701|P1|Participant Flow|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
319777|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
319778|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
319779|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
319780|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
319781|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
319782|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
319783|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
319784|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
319785|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
319786|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
319787|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
319788|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
319789|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
319790|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
319791|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
319792|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
319793|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
319794|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
319795|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
319796|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
319797|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
319798|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
319799|NCT01195701|E2|Reported Event|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
319800|NCT01195701|E1|Reported Event|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
319801|NCT01195675|B1|Baseline|Study Overall|Total number of patients randomised and treated in the study.
319837|NCT01195662|P1|Participant Flow|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319802|NCT01195675|P1|Participant Flow|Study Overall|"Total number of patients randomised and treated in the study. This was a randomised, placebo controlled, 5-period crossover trial, participants were randomised to one of ten possible treatment sequences. The treatments administered were~25mg empa administered orally on day 1 of the treatment period~200mg empa administered orally on day 1 of the treatment period~400mg moxifloxacin administered orally on day 1 of the treatment period~Placebo 1 administered orally on day 1 of the treatment period~Placebo 2 administered orally on day 1 of the treatment period~The trial was double-blind for the placebo and Empagliflozin (Empa) treatments, but open-label for the moxifloxacin treatment. A washout period of at least 1 week was respected between drug administrations."
319803|NCT01195675|O4|Outcome|Moxifloxacin|Single oral dose of moxifloxacin 400 mg (1 tablet)
319804|NCT01195675|O3|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (consisting of 8 tablets with strength 25 mg)
319805|NCT01195675|O2|Outcome|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet with strength 25mg) plus 7 tablets of placebo.
319806|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
319807|NCT01195675|O3|Outcome|Moxifloxacin|Single oral dose of moxifloxacin 400 mg (1 tablet)
319808|NCT01195675|O2|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (8 tablets of 25 mg)
319809|NCT01195675|O1|Outcome|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet) plus 7 tablets of placebo.
319810|NCT01195675|O3|Outcome|Moxifloxacin|Single oral dose of moxifloxacin 400 mg (1 tablet)
319811|NCT01195675|O2|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (consisting of 8 tablets with strength 25 mg)
319812|NCT01195675|O1|Outcome|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet) plus 7 tablets of placebo.
319813|NCT01195675|O2|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (consisting of 8 tablets with strength 25 mg)
319814|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
319815|NCT01195675|O2|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (consisting of 8 tablets with strength 25 mg)
319816|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
319817|NCT01195675|O2|Outcome|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet with strength 25mg) plus 7 tablets of placebo.
319818|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
319819|NCT01195675|O2|Outcome|Moxifloxacin|Single oral dose of moxifloxacin 400 mg (1 tablet)
319820|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
319821|NCT01195675|O2|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (consisting of 8 tablets with strength 25 mg)
319822|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
319823|NCT01195675|O2|Outcome|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet with strength 25mg) plus 7 tablets of placebo.
319824|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
319825|NCT01195675|O2|Outcome|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet with strength 25mg) plus 7 tablets of placebo.
319826|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
319827|NCT01195675|E4|Reported Event|Moxifloxacin|Single oral dose of moxifloxacin 400 mg (1 tablet)
319828|NCT01195675|E3|Reported Event|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (8 tablets of 25 mg)
319829|NCT01195675|E2|Reported Event|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet) plus 7 tablets of placebo.
319830|NCT01195675|E1|Reported Event|Placebo|Single oral dose of placebo (8 tablets).
319831|NCT01195662|B4|Baseline|Total|Total of all reporting groups
319832|NCT01195662|B3|Baseline|Dagagliflozin 5 mg (Arm Discontinued With Amendment 8)|Dapagliflozin: Tablets, Oral, 5 mg, once daily, Up to 12 weeks. This arm discontinued with implementation of Amendment 8 to the protocol (1 November 2011). Study continued to enroll participants in other 2 arms post Amendment 8. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319833|NCT01195662|B2|Baseline|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319834|NCT01195662|B1|Baseline|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319835|NCT01195662|P3|Participant Flow|Dagagliflozin 5 mg (Arm Discontinued With Amendment 8)|"Dapagliflozin: Tablets, Oral, 5 mg, once a day for up to12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.~This arm was discontinued with Amendment 8 to the protocol (implemented 1 November 2011) and the other 2 arms continued to enroll. This arm is not included in primary and secondary efficacy analysis."
319836|NCT01195662|P2|Participant Flow|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319874|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
319875|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
319838|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319839|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319840|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319841|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319842|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319843|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319844|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319845|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319846|NCT01195662|O3|Outcome|Dagagliflozin 5 mg (Arm Discontinued With Amendment 8)|"Dapagliflozin: Tablets, Oral, 5 mg, once a day for up to12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.~This arm was discontinued with Amendment 8 to the protocol (implemented 1 November 2011) and the other 2 arms continued to enroll. This arm is not included in primary and secondary efficacy analysis."
319847|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319848|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319849|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319850|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319851|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319852|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319876|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
320017|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
319853|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319854|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks.Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319855|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319856|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319857|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319858|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319859|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319860|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319861|NCT01195662|E3|Reported Event|Dagagliflozin 5 mg (Arm Discontinued With Amendment 8)|"Dapagliflozin: Tablets, Oral, 5 mg, once a day for up to12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.~This arm was discontinued with Amendment 8 to the protocol (implemented 1 November 2011) and the other 2 arms continued to enroll. This arm is not included in primary and secondary efficacy analysis."
319862|NCT01195662|E2|Reported Event|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319863|NCT01195662|E1|Reported Event|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
319864|NCT01195636|B3|Baseline|Total|Total of all reporting groups
319865|NCT01195636|B2|Baseline|Placebo First, Then XPF-002|Placebo ointment applied twice daily for 3 weeks followed by XPF-002 ointment applied twice daily for 3 weeks (after a washout period)
319866|NCT01195636|B1|Baseline|XPF-002 First, Then Placebo|XPF-002 ointment applied twice daily for 3 weeks followed by Placebo ointment applied twice daily for 3 weeks (after a washout period)
319867|NCT01195636|P2|Participant Flow|Placebo First, Then XPF-002|In the first intervention period Placebo ointment was applied twice daily for 3 weeks. After a washout period, XPF-002 ointment (8% strength) was applied twice daily for 3 weeks in the second intervention period.
319868|NCT01195636|P1|Participant Flow|XPF-002 First, Then Placebo|In the first intervention period XPF-002 ointment (8% strength) was applied twice daily for 3 weeks. After a washout period, Placebo ointment was applied twice daily for 3 weeks in the second intervention period.
319869|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
319870|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
319871|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
319872|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
319873|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
320004|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
319877|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
319878|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
319879|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
319880|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
319881|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
319882|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
319883|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
319884|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
319885|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
319886|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
319887|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
319888|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
319889|NCT01195636|E2|Reported Event|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
319890|NCT01195636|E1|Reported Event|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
319891|NCT01195623|B3|Baseline|Total|Total of all reporting groups
319892|NCT01195623|B2|Baseline|Varicose Vein Surgery Without Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination only
319893|NCT01195623|B1|Baseline|Varicose Vein Surgery With Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail
319894|NCT01195623|P2|Participant Flow|Varicose Vein Surgery Without Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination only
319895|NCT01195623|P1|Participant Flow|Varicose Vein Surgery With Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail
319896|NCT01195623|O2|Outcome|Varicose Vein Surgery Without Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination only
319897|NCT01195623|O1|Outcome|Varicose Vein Surgery With Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail
319898|NCT01195623|O2|Outcome|Varicose Vein Surgery Without Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination only
319899|NCT01195623|O1|Outcome|Varicose Vein Surgery With Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail
319900|NCT01195623|E2|Reported Event|Varicose Vein Surgery Without Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination only
319901|NCT01195623|E1|Reported Event|Varicose Vein Surgery With Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail
319902|NCT01195597|B1|Baseline|ENDD Group|Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges.
319903|NCT01195597|P1|Participant Flow|ENDD Group|Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges.
319904|NCT01195597|O1|Outcome|Smokers Not Willing to Quit|"7.4 mg nicotine cartridges (Original cartridges; Arbi Group Srl, Milano, Italy)"
319905|NCT01195597|O1|Outcome|Smokers Not Willing to Quit|"7.4 mg nicotine cartridges (Original cartridges; Arbi Group Srl, Milano, Italy)"
319906|NCT01195597|E1|Reported Event|ENDD Group|Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges.
319907|NCT01195584|B4|Baseline|Total|Total of all reporting groups
319908|NCT01195584|B3|Baseline|BMI >= 30|Body Mass Index (BMI) according to WHO definition. BMI >= 30 is defined as 'obese'.
319909|NCT01195584|B2|Baseline|25 <= BMI < 30|Body Mass Index (BMI) according to WHO definition. BMI >= 25 and < 30 is defined as 'overweight'.
319910|NCT01195584|B1|Baseline|BMI < 25|Body Mass Index (BMI) according to WHO definition. BMI < 25 is defined as 'normal weight'.
319911|NCT01195584|P3|Participant Flow|BMI >= 30|Body Mass Index (BMI) according to WHO definition. BMI >= 30 is defined as 'obese'.
319912|NCT01195584|P2|Participant Flow|25 <= BMI < 30|Body Mass Index (BMI) according to WHO definition. BMI >= 25 and < 30 is defined as 'overweight'.
319913|NCT01195584|P1|Participant Flow|BMI < 25|Body Mass Index (BMI) according to WHO definition. BMI < 25 is defined as 'normal weight'.
319914|NCT01195584|O1|Outcome|Hospitalization|Days of hospitalization
319915|NCT01195584|O1|Outcome|Hospitalization|Days of hospitalization
319916|NCT01195584|O1|Outcome|Number of Segments|Number of affected spine segments
319917|NCT01195584|O1|Outcome|Blood Loss|
319918|NCT01195584|O1|Outcome|Duration|Duration of surgery
320005|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
319919|NCT01195584|O1|Outcome|Complications|Postoperative complications; complications include fever, subfebrile temerature, neurogenic deficit, temorary meningism, pulmonary embolism, TIA, cardiac ischemia, urinary tract infection, respiratory infection and pneumonia
319920|NCT01195584|E3|Reported Event|BMI >= 30|Body Mass Index (BMI) according to WHO definition. BMI >= 30 is defined as 'obese'.
319921|NCT01195584|E2|Reported Event|25 <= BMI < 30|Body Mass Index (BMI) according to WHO definition. BMI >= 25 and < 30 is defined as 'overweight'.
319922|NCT01195584|E1|Reported Event|BMI < 25|Body Mass Index (BMI) according to WHO definition. BMI < 25 is defined as 'normal weight'.
319923|NCT01195467|B1|Baseline|Single Arm|No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and trested for 12 weeks.
319924|NCT01195467|P1|Participant Flow|Single Arm|No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and trested for 12 weeks.
319925|NCT01195467|O1|Outcome|Single Arm|No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and treated for 12 weeks.
319926|NCT01195467|O1|Outcome|Single Arm|No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and treated for 12 weeks.
319927|NCT01195467|E1|Reported Event|Single Arm|No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and treated for 12 weeks.
319928|NCT01195415|B1|Baseline|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
319929|NCT01195415|P1|Participant Flow|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
319930|NCT01195415|O1|Outcome|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
319931|NCT01195415|O1|Outcome|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
319932|NCT01195415|O1|Outcome|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
319933|NCT01195415|O1|Outcome|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
319934|NCT01195415|E1|Reported Event|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
319935|NCT01195363|B3|Baseline|Total|Total of all reporting groups
319936|NCT01195363|B2|Baseline|Quetiapine SR Placebo|mood stabilizer plus quetiapine SR placebo
319937|NCT01195363|B1|Baseline|Active Quetiapine SR|mood stabilizer plus active quetiapine sr
319938|NCT01195363|P2|Participant Flow|Quetiapine sr Placebo 200-600mg, po, qd|mood stabilizer plus quetiapine SR placebo
319939|NCT01195363|P1|Participant Flow|Quetiapine SR, 200-600mg , po, QD|mood stabilizer plus active quetiapine SR
319940|NCT01195363|O2|Outcome|Placebo Quetiapine S.R. 200-600mg, po, qd|mood stabilizer plus quetiapine S.R. placebo
319941|NCT01195363|O1|Outcome|Active Quetiapine S.R., 200-600mg, po, qd|Atypical antipsychotic quetiapine S.R. plus mood stabilizer
319942|NCT01195363|E2|Reported Event|Mood Stabilizer Plus Quetiapine sr Placebo|mood stabilizer plus quetiapine SR placebo
319943|NCT01195363|E1|Reported Event|Mood Stabilizer Plus Quetiapine SR|mood stabilizer plus active quetiapine SR
319944|NCT01195272|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
319945|NCT01195272|P1|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) intravenously (IV), once every 4 weeks up to 52 weeks (total of 13 infusions).
319946|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
319947|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
319948|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
319949|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
319950|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
319951|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
319952|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
319953|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
319954|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
319955|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
319956|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
319957|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
319958|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
319959|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
319960|NCT01195272|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
319961|NCT01195116|B3|Baseline|Total|Total of all reporting groups
319962|NCT01195116|B2|Baseline|Normal Saline|Normal Saline: 1mcg/kg/hr
319963|NCT01195116|B1|Baseline|Dexmedetomidine|"Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs.~Dexmedetomidine: 1 mcg/kg/hour"
319964|NCT01195116|P2|Participant Flow|Normal Saline|Normal Saline: 1mcg/kg/hr
319965|NCT01195116|P1|Participant Flow|Dexmedetomidine|"Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs.~Dexmedetomidine: 1 mcg/kg/hour"
319966|NCT01195116|O2|Outcome|Normal Saline|Normal Saline: 1mcg/kg/hr
319967|NCT01195116|O1|Outcome|Dexmedetomidine|"Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs.~Dexmedetomidine: 1 mcg/kg/hour"
319968|NCT01195116|E2|Reported Event|Normal Saline|Normal Saline: 1mcg/kg/hr
319969|NCT01195116|E1|Reported Event|Dexmedetomidine|"Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs.~Dexmedetomidine: 1 mcg/kg/hour"
319970|NCT01195103|B4|Baseline|Total|Total of all reporting groups
319971|NCT01195103|B3|Baseline|Placebo + Midazolam|Placebo initial bolus with dose of midazolam based on patient's weight
319972|NCT01195103|B2|Baseline|6.5 mg/kg Lusedra|6.5 mg/kg Lusedra initial bolus
319973|NCT01195103|B1|Baseline|10 mg/kg Lusedra|10 mg/kg Lusedra initial bolus
319974|NCT01195103|P3|Participant Flow|Placebo + Midazolam|Placebo initial bolus with dose of midazolam based on patient's weight
319975|NCT01195103|P2|Participant Flow|6.5 mg/kg Lusedra|6.5 mg/kg Lusedra initial bolus
319976|NCT01195103|P1|Participant Flow|10 mg/kg Lusedra|10 mg/kg Lusedra initial bolus
319977|NCT01195103|O3|Outcome|Placebo + Midazolam|Placebo initial bolus with dose of midazolam based on patient's weight
319978|NCT01195103|O2|Outcome|6.5 mg/kg Lusedra|6.5 mg/kg Lusedra initial bolus
319979|NCT01195103|O1|Outcome|10 mg/kg Lusedra|10 mg/kg Lusedra initial bolus
319980|NCT01195103|E3|Reported Event|Placebo + Midazolam|Placebo initial bolus with dose of midazolam based on patient's weight
319981|NCT01195103|E2|Reported Event|6.5 mg/kg Lusedra|6.5 mg/kg Lusedra initial bolus
319982|NCT01195103|E1|Reported Event|10 mg/kg Lusedra|10 mg/kg Lusedra initial bolus
319983|NCT01195090|B3|Baseline|Total|Total of all reporting groups
319984|NCT01195090|B2|Baseline|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
319985|NCT01195090|B1|Baseline|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
319986|NCT01195090|P2|Participant Flow|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
319987|NCT01195090|P1|Participant Flow|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
319988|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
319989|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
319990|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
319991|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
319992|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
319993|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
319994|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
319995|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
319996|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
319997|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
319998|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
319999|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
320000|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
320001|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
320002|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
320003|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
320018|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
320019|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
320020|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
320021|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
320022|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
320023|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
320024|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
320025|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
320026|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
320027|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
320028|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
320029|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
320030|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
320031|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
320032|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
320033|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
320034|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
320035|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
320036|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
320037|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
320038|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
320039|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
320040|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
320041|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
320042|NCT01195090|E2|Reported Event|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
320043|NCT01195090|E1|Reported Event|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
320044|NCT01195025|B1|Baseline|Dilution Effects of iv Fluids|"Three experiments:~A. acetated Ringers 20 ml/kg bodyweight during 30 minutes B. Hydroxy ethyl starch (HES) 6% 10 mL/kg bodyweight during 30 min C. A combination of A and B. HES during 0-30 min and Ringer's during 105-135 minutes."
320045|NCT01195025|P5|Participant Flow|A. Colloid+Acetated Ringers, B.Colloid and C. Acetated Ringers|"First intervention: A. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples.~Washout >7 days~Second intervention: B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.~Washout > 7 Days~Third intervention: C. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected."
320046|NCT01195025|P4|Participant Flow|A.Colloid, B. Acetated Ringers and C. Colloid+Acetated Ringers|"First intervention: A. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.~Washout >7 days~Second intervention: B. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected.~Washout > 7 Days~Third intervention: C. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples."
320047|NCT01195025|P3|Participant Flow|A. Acetated Ringers, B. Colloid+Acetated Ringers and C.Colloid|"First intervention: A. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by 150 minutes of equilibration, when blood samples were collected~Washout >7 days~Second intervention: B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples.~Washout > 7 Days~Third intervention: C. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples."
320048|NCT01195025|P2|Participant Flow|A. Colloid, B. Colloid+Acetated Ringers and C.Acetated Ringers|"First intervention: A. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.~Washout >7 days~Second intervention: B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples.~Washout > 7 Days~Third intervention: C. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected"
320049|NCT01195025|P1|Participant Flow|A. Acetated Ringers, B.Colloid and C. Colloid+Acetated Ringers|"First intervention: A. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected.~Washout >7 days~Second intervention: B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.~Washout > 7 Days~Third intervention: C. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples."
320050|NCT01195025|O1|Outcome|Hydroxyethyl Starch, Ringers and a Combination of Both.|A. acetated Ringers 20 ml/kg bodyweight during 30 minutes B. Hydroxyethyl starch (HES 6 %, 10 ml/kg bodyweight during 30 minutes. C. Hydroxyethyl starch (HES 6 %, 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes.
320051|NCT01195025|O1|Outcome|Colloid (Voluven), Acetated Ringers and a Combination of Both.|"A. acetated Ringers 20 ml/kg bodyweight during 30 minutes B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes~The combined experiment is not included since infusions were performed in sequence, which made the comparison of the bias for the two different fluids irrelevant."
320052|NCT01195025|O1|Outcome|Venous Hemoglobin and Non-invasive Hemoglobin (SpHb)|"A comparison of all paired hemoglobin measurements (B-Hb and SpHb) during the experiments for all the 10 volunteers.~Relative difference(%) = (SpHb - Hb)/((Hb+SpHb)/2) x 100"
320053|NCT01195025|O1|Outcome|Hydroxyethyl Starch, Ringers and a Combination of Both.|A. acetated Ringers 20 ml/kg bodyweight during 30 minutes B. Hydroxyethyl starch (HES 6 %, 10 ml/kg bodyweight during 30 minutes. C. Hydroxyethyl starch (HES 6 %, 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes.
320054|NCT01195025|E1|Reported Event|Colloid-, Acetated Ringers and Combined|"Voluven, acetated Ringers: Infusions at three different occasions separated by at least one week.~A. acetated Ringers 25 ml/kg bodyweight during 30 minutes B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes. C. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 15 ml/kg bodyweight during 30 minutes."
320055|NCT01194999|B1|Baseline|Pubovaginal Sling Procedure|Patients undergoing pubovaginal slings for stress urinary incontinence.
320056|NCT01194999|P1|Participant Flow|Pubovaginal Sling Procedure|Patients undergoing pubovaginal slings for stress urinary incontinence.
320057|NCT01194999|O1|Outcome|Pubovaginal Sling Procedure|Patients undergoing pubovaginal slings for stress urinary incontinence.
320058|NCT01194999|E1|Reported Event|Pubovaginal Sling Procedure|Patients undergoing pubovaginal slings for stress urinary incontinence.
320059|NCT01194973|B1|Baseline|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
320060|NCT01194973|P1|Participant Flow|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
320061|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
320062|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
320063|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
320064|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
320065|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
320066|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
320067|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
320068|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
320069|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
320070|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
320071|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
320072|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
320073|NCT01194973|E1|Reported Event|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
320074|NCT01194908|B1|Baseline|Arm A|"Patients treated with decitabine and LBH589~Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2~Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2"
320075|NCT01194908|P1|Participant Flow|Arm A|"Patients treated with decitabine and LBH589~Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2~Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2"
320076|NCT01194908|O1|Outcome|Arm A|"Patients treated with decitabine and LBH589~Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2~Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2"
320077|NCT01194908|O1|Outcome|Arm A|"Patients treated with decitabine and LBH589~Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2~Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2"
320078|NCT01194908|E1|Reported Event|Arm A|"Patients treated with decitabine and LBH589~Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2~Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2"
320079|NCT01194869|B1|Baseline|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
320080|NCT01194869|P1|Participant Flow|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
320081|NCT01194869|O1|Outcome|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
320082|NCT01194869|O1|Outcome|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
320083|NCT01194869|O1|Outcome|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
320084|NCT01194869|E1|Reported Event|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
320085|NCT01194856|B3|Baseline|Total|Total of all reporting groups
320086|NCT01194856|B2|Baseline|Arm B - Atazanavir/Ritonavir|"Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks~Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks"
320087|NCT01194856|B1|Baseline|Efavirenz 600 mg|"Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen~Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks"
320088|NCT01194856|P2|Participant Flow|Arm B - Atazanavir/Ritonavir|"Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks~Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks"
320089|NCT01194856|P1|Participant Flow|Efavirenz 600 mg|"Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen~Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks"
320090|NCT01194856|O2|Outcome|Arm B - Atazanavir/Ritonavir|"Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks~Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks"
320091|NCT01194856|O1|Outcome|Efavirenz 600 mg|"Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen~Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks"
320092|NCT01194856|O2|Outcome|Arm B - Atazanavir/Ritonavir|"Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks~Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks"
320093|NCT01194856|O1|Outcome|Efavirenz 600 mg|"Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen~Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks"
320094|NCT01194856|O2|Outcome|Arm B - Atazanavir/Ritonavir|"Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks~Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks"
320095|NCT01194856|O1|Outcome|Efavirenz 600 mg|"Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen~Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks"
320096|NCT01194856|O2|Outcome|Arm B - Atazanavir/Ritonavir|"Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks~Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks"
320097|NCT01194856|O1|Outcome|Efavirenz 600 mg|"Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen~Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks"
320098|NCT01194856|O2|Outcome|Arm B - Atazanavir/Ritonavir|"Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks~Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks"
320099|NCT01194856|O1|Outcome|Efavirenz 600 mg|"Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen~Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks"
320100|NCT01194856|O2|Outcome|Arm B - Atazanavir/Ritonavir|"Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks~Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks"
320101|NCT01194856|O1|Outcome|Efavirenz 600 mg|"Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen~Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks"
320102|NCT01194856|O2|Outcome|Arm B - Atazanavir/Ritonavir|"Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks~Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks"
320103|NCT01194856|O1|Outcome|Efavirenz 600 mg|"Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen~Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks"
320104|NCT01194856|O2|Outcome|Arm B - Atazanavir/Ritonavir|"Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks~Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks"
320105|NCT01194856|O1|Outcome|Efavirenz 600 mg|"Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen~Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks"
320106|NCT01194856|E2|Reported Event|Arm B - Atazanavir/Ritonavir|"Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks~Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks"
320107|NCT01194856|E1|Reported Event|Efavirenz 600 mg|"Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen~Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks"
320108|NCT01194830|B3|Baseline|Total|Total of all reporting groups
320109|NCT01194830|B2|Baseline|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
320110|NCT01194830|B1|Baseline|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
320111|NCT01194830|P2|Participant Flow|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
320112|NCT01194830|P1|Participant Flow|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
320113|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
320114|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
320115|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
320116|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
320117|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
320118|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
320119|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
320120|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
320121|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
320122|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
320123|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
320124|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
320125|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
320126|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
320127|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
320128|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
320129|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
320130|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
320131|NCT01194830|E2|Reported Event|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
320132|NCT01194830|E1|Reported Event|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
320133|NCT01194674|B1|Baseline|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
320134|NCT01194674|P1|Participant Flow|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
320135|NCT01194674|O1|Outcome|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
320136|NCT01194674|O1|Outcome|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
320137|NCT01194674|O1|Outcome|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
320138|NCT01194674|O1|Outcome|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
320139|NCT01194674|E1|Reported Event|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
320140|NCT01194570|B3|Baseline|Total|Total of all reporting groups
320141|NCT01194570|B2|Baseline|Ocrelizumab 600 mg|Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
320142|NCT01194570|B1|Baseline|Placebo|Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
320143|NCT01194570|P2|Participant Flow|Ocrelizumab 600 mg|Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
320144|NCT01194570|P1|Participant Flow|Placebo|Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
320145|NCT01194570|O2|Outcome|Ocrelizumab 600 mg|Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
320146|NCT01194570|O1|Outcome|Placebo|Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
320147|NCT01194570|O2|Outcome|Ocrelizumab 600 mg|Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
320148|NCT01194570|O1|Outcome|Placebo|Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
320149|NCT01194570|O2|Outcome|Ocrelizumab 600 mg|Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
320150|NCT01194570|O1|Outcome|Placebo|Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
320151|NCT01194570|O2|Outcome|Ocrelizumab 600 mg|Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
320152|NCT01194570|O1|Outcome|Placebo|Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
320153|NCT01194570|O2|Outcome|Ocrelizumab 600 mg|Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
320154|NCT01194570|O1|Outcome|Placebo|Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
320155|NCT01194570|O2|Outcome|Ocrelizumab 600 mg|Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
320156|NCT01194570|O1|Outcome|Placebo|Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
320157|NCT01194570|O2|Outcome|Ocrelizumab 600 mg|Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
320158|NCT01194570|O1|Outcome|Placebo|Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
320159|NCT01194570|E2|Reported Event|Ocrelizumab 600 mg|Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
320160|NCT01194570|E1|Reported Event|Placebo|Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
320161|NCT01194531|B3|Baseline|Total|Total of all reporting groups
320162|NCT01194531|B2|Baseline|TEST Arm|"Subjects assigned to this arm of the study will receive PGS testing.~24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS)"
320163|NCT01194531|B1|Baseline|CONTROL Arm|Subjects assigned to this arm of the study will receive no PGS testing.
320164|NCT01194531|P2|Participant Flow|TEST Arm|"Subjects assigned to this arm of the study will receive PGS testing.~24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS)"
320165|NCT01194531|P1|Participant Flow|CONTROL Arm|Subjects assigned to this arm of the study will receive no PGS testing.
320166|NCT01194531|O2|Outcome|TEST Arm|"Subjects assigned to this arm of the study will receive PGS testing.~24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS)"
320167|NCT01194531|O1|Outcome|CONTROL Arm|Subjects assigned to this arm of the study will receive no PGS testing.
320168|NCT01194531|E2|Reported Event|TEST Arm|"Subjects assigned to this arm of the study will receive PGS testing.~24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS)"
320169|NCT01194531|E1|Reported Event|CONTROL Arm|Subjects assigned to this arm of the study will receive no PGS testing.
320170|NCT01194479|B3|Baseline|Total|Total of all reporting groups
320171|NCT01194479|B2|Baseline|Type 1 Diabetics|"The active group were participants with type 1 diabetes.~Formoterol: Formoterol inhaler, 12mcg capsules, 4 capsules for one administration~Placebo: Participants in both arms received placebo on 1 of the 2 visits."
320172|NCT01194479|B1|Baseline|Healthy Volunteers|"The control group were participants without diabetes, matched by sex, age and BMI to the active comparator group.~Formoterol: Formoterol inhaler, 12mcg capsules, 4 capsules for one administration~Placebo: Participants in both arms received placebo on 1 of the 2 visits."
320173|NCT01194479|P4|Participant Flow|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol first, then Placebo.
320174|NCT01194479|P3|Participant Flow|Type 1 Diabetics: Placebo|Type 1 Diabetics that received Placebo first, then Formoterol.
320175|NCT01194479|P2|Participant Flow|Control: Formoterol|Healthy volunteers that received Formoterol first, then Placebo.
320176|NCT01194479|P1|Participant Flow|Control: Placebo|Healthy volunteers that received Placebo first, the Formoterol.
320177|NCT01194479|O4|Outcome|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol on the first or second visit.
320178|NCT01194479|O3|Outcome|Type 1 Diabetics: Placebo|Type 1 Diabetics that received placebo on the first or second visit.
320179|NCT01194479|O2|Outcome|Control: Formoterol|Healthy volunteers that received Formoterol on the first or second visit.
320180|NCT01194479|O1|Outcome|Control: Placebo|Healthy volunteers that received Placebo on the first or second visit.
320181|NCT01194479|O4|Outcome|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol on the first or second visit.
320182|NCT01194479|O3|Outcome|Type 1 Diabetics: Placebo|Type 1 Diabetics that received placebo on the first or second visit.
320183|NCT01194479|O2|Outcome|Control: Formoterol|Healthy volunteers that received Formoterol on the first or second visit.
320184|NCT01194479|O1|Outcome|Control: Placebo|Healthy volunteers that received Placebo on the first or second visit.
320185|NCT01194479|O4|Outcome|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol on the first or second visit.
320186|NCT01194479|O3|Outcome|Type 1 Diabetics: Placebo|Type 1 Diabetics that received placebo on the first or second visit.
320187|NCT01194479|O2|Outcome|Control: Formoterol|Healthy volunteers that received Formoterol on the first or second visit.
320188|NCT01194479|O1|Outcome|Control: Placebo|Healthy volunteers that received Placebo on the first or second visit.
320189|NCT01194479|O4|Outcome|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol on the first or second visit.
320190|NCT01194479|O3|Outcome|Type 1 Diabetics: Placebo|Type 1 Diabetics that received placebo on the first or second visit.
320191|NCT01194479|O2|Outcome|Control: Formoterol|Healthy volunteers that received Formoterol on the first or second visit.
320192|NCT01194479|O1|Outcome|Control: Placebo|Healthy volunteers that received Placebo on the first or second visit.
320193|NCT01194479|E4|Reported Event|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol on the first visit.
320194|NCT01194479|E3|Reported Event|Type 1 Diabetics: Placebo|Type 1 Diabetics that received placebo on the first visit.
320195|NCT01194479|E2|Reported Event|Control: Formoterol|Healthy volunteers that received Formoterol on the first visit.
320196|NCT01194479|E1|Reported Event|Control: Placebo|Healthy volunteers that received Placebo on the first visit.
320197|NCT01194453|B3|Baseline|Total|Total of all reporting groups
320198|NCT01194453|B2|Baseline|Group B|cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
320199|NCT01194453|B1|Baseline|Group A|cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
320200|NCT01194453|P2|Participant Flow|Group B|cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
320201|NCT01194453|P1|Participant Flow|Group A|cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
320202|NCT01194453|O2|Outcome|Group B|cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
320203|NCT01194453|O1|Outcome|Group A|cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
320204|NCT01194453|O2|Outcome|Group B|cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
320205|NCT01194453|O1|Outcome|Group A|cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
320206|NCT01194453|E2|Reported Event|Group B|cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
320207|NCT01194453|E1|Reported Event|Group A|cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
320208|NCT01194440|B1|Baseline|Arm I|"Patients receive zoledronic acid IV at months 1 and 6. Beginning 14 days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12 months in the absence of disease progression or unacceptable toxicity.~letrozole: Given orally~zoledronic acid: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~mass spectrometry: Correlative studies~bone scan: Correlative studies~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies~pharmacogenomic studies: Correlative studies~high performance liquid chromatography: Correlative studies"
320304|NCT01194258|O2|Outcome|Insulin Lispro|100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
321413|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
320209|NCT01194440|P1|Participant Flow|Arm I - IV Zoledronic Acid Prophylaxis|"Patients receive zoledronic acid IV at months 1 and 6. Beginning 14 days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12 months in the absence of disease progression or unacceptable toxicity.~letrozole: Given orally~zoledronic acid: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~mass spectrometry: Correlative studies~bone scan: Correlative studies~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies~pharmacogenomic studies: Correlative studies~high performance liquid chromatography: Correlative studies"
320210|NCT01194440|O1|Outcome|Arm I|"Patients receive zoledronic acid IV at months 1 and 6. Beginning 14 days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12 months in the absence of disease progression or unacceptable toxicity.~letrozole: Given orally~zoledronic acid: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~mass spectrometry: Correlative studies~bone scan: Correlative studies~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies~pharmacogenomic studies: Correlative studies~high performance liquid chromatography: Correlative studies"
320211|NCT01194440|E1|Reported Event|Arm I|"Patients receive zoledronic acid IV at months 1 and 6. Beginning 14 days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12 months in the absence of disease progression or unacceptable toxicity.~letrozole: Given orally~zoledronic acid: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~mass spectrometry: Correlative studies~bone scan: Correlative studies~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies~pharmacogenomic studies: Correlative studies~high performance liquid chromatography: Correlative studies"
320212|NCT01194427|B1|Baseline|Vorinostat and Tamoxifen|Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
320213|NCT01194427|P1|Participant Flow|Vorinostat and Tamoxifen|Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
320214|NCT01194427|O1|Outcome|Vorinostat and Tamoxifen|Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
320215|NCT01194427|E1|Reported Event|Vorinostat and Tamoxifen|Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
320216|NCT01194414|B3|Baseline|Total|Total of all reporting groups
320217|NCT01194414|B2|Baseline|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
320218|NCT01194414|B1|Baseline|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
320219|NCT01194414|P4|Participant Flow|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
320220|NCT01194414|P3|Participant Flow|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320221|NCT01194414|P2|Participant Flow|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320222|NCT01194414|P1|Participant Flow|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320223|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
320224|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320225|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320226|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320305|NCT01194258|O1|Outcome|Analog-PH20|100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
320227|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
320228|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320229|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320230|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320231|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
320232|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320233|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320234|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320235|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
320236|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
320237|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
320238|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
320239|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
320240|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
320241|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
320242|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
320243|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
320244|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
320245|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
320246|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320247|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320248|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320249|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
320250|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320251|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320252|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320253|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
320254|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320255|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320256|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320257|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
320258|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320259|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320260|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320306|NCT01194258|O2|Outcome|Insulin Lispro|100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
320261|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
320262|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
320263|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
320264|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
320265|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
320266|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
320267|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
320268|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
320269|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
320270|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
320271|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
320272|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320273|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320274|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320275|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
320276|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
320277|NCT01194414|E4|Reported Event|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
320278|NCT01194414|E3|Reported Event|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320609|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320279|NCT01194414|E2|Reported Event|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320280|NCT01194414|E1|Reported Event|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
320281|NCT01194297|B3|Baseline|Total|Total of all reporting groups
320282|NCT01194297|B2|Baseline|Live Attenuated Influenza Vaccine|"One dose of live attenuated influenza vaccine, according to routine immunization recommendations~Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations"
320283|NCT01194297|B1|Baseline|Inactivated Influenza Vaccine|"One dose of inactivated influenza vaccine, according to routine immunization recommendations~Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations"
320284|NCT01194297|P2|Participant Flow|Live Attenuated Influenza Vaccine|"One dose of live attenuated influenza vaccine, according to routine immunization recommendations~Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations"
320285|NCT01194297|P1|Participant Flow|Inactivated Influenza Vaccine|"One dose of inactivated influenza vaccine, according to routine immunization recommendations~Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations"
320286|NCT01194297|O2|Outcome|Live Attenuated Influenza Vaccine|"One dose of live attenuated influenza vaccine, according to routine immunization recommendations~Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations"
320287|NCT01194297|O1|Outcome|Inactivated Influenza Vaccine|"One dose of inactivated influenza vaccine, according to routine immunization recommendations~Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations"
320288|NCT01194297|O2|Outcome|Live Attenuated Influenza Vaccine|"One dose of live attenuated influenza vaccine, according to routine immunization recommendations~Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations"
320289|NCT01194297|O1|Outcome|Inactivated Influenza Vaccine|"One dose of inactivated influenza vaccine, according to routine immunization recommendations~Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations"
320290|NCT01194297|E2|Reported Event|Live Attenuated Influenza Vaccine|"One dose of live attenuated influenza vaccine, according to routine immunization recommendations~Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations"
320291|NCT01194297|E1|Reported Event|Inactivated Influenza Vaccine|"One dose of inactivated influenza vaccine, according to routine immunization recommendations~Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations"
320292|NCT01194258|B1|Baseline|All Study Participants|All participants in the study, including those who were enrolled but were not randomized.
320293|NCT01194258|P5|Participant Flow|Aspart-PH20, Then Insulin Lispro|"Participants received SC injection of 100 U/mL insulin aspart and 5 µg rHuPH20 (Aspart-PH20) pre-meals for 12 weeks during Treatment Period 1 of the study.~Then, participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 2 of the study."
320294|NCT01194258|P4|Participant Flow|Insulin Lispro, Then Aspart-PH20|"Participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 of the study.~Then, participants received a SC injection of 100 U/mL insulin aspart and 5 µg rHuPH20 (combined: Aspart-PH20) pre-meals for 12 weeks during Treatment Period 2 of the study."
320295|NCT01194258|P3|Participant Flow|Lispro-PH20, Then Insulin Lispro|"Participants received a SC injection of 100 U/mL insulin lispro and 5 µg rHuPH20 (Lispro-PH20) pre-meals for 12 weeks during Treatment Period 1 of the study.~Then, participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 2 of the study."
320296|NCT01194258|P2|Participant Flow|Insulin Lispro, Then Lispro-PH20|"Participants received a subcutaneous (SC) injection of 100 units per milliliter (U/mL) insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 of the study.~Then, participants received a SC injection of 100 U insulin lispro and 5 micrograms (µg) recombinant human hyaluronidase PH20 (rHuPH20) (combined: Lispro-PH20) pre-meals for 12 weeks during Treatment Period 2 of the study."
320297|NCT01194258|P1|Participant Flow|All Enrolled Participants|"Prior to randomization, all enrolled participants underwent a titration period of 4 to 6 weeks in which they received 100 U/mL insulin glulisine, injected SC, pre-meals, with doses titrated to each participant individually.~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
320298|NCT01194258|O2|Outcome|Insulin Lispro|100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
320299|NCT01194258|O1|Outcome|Analog-PH20|100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
320300|NCT01194258|O2|Outcome|Insulin-lispro|100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
320301|NCT01194258|O1|Outcome|Analog-PH20|100 U/mL insulin analog (Insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
320302|NCT01194258|O2|Outcome|Insulin Lispro|100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
320303|NCT01194258|O1|Outcome|Analog-PH20|100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
320610|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320307|NCT01194258|O1|Outcome|Analog-PH20|100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
320308|NCT01194258|O2|Outcome|Insulin Lispro|100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
320309|NCT01194258|O1|Outcome|Analog-PH20|100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
320310|NCT01194258|E5|Reported Event|Aspart-PH20|"Participants received a SC injection of 100 U/mL insulin aspart and 5 μg rHuPH20 pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
320311|NCT01194258|E4|Reported Event|Insulin Lispro (Aspart-PH20 Cohort)|"Participants randomized to the Aspart-PH20 cohort.~Participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
320312|NCT01194258|E3|Reported Event|Lispro-PH20|"Participants received a SC injection of 100 U/mL insulin lispro with 5 micrograms (μg) rHuPH20 pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
320313|NCT01194258|E2|Reported Event|Insulin Lispro (Lispro-PH20 Cohort)|"Participants randomized to the Lispro-PH20 cohort.~Participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
320314|NCT01194258|E1|Reported Event|Titration Period|Prior to randomization, all enrolled participants underwent a titration period of 4 to 6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually.
320315|NCT01194245|B6|Baseline|Total|Total of all reporting groups
320316|NCT01194245|B5|Baseline|Insulin Lispro First, Then Aspart-PH20|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.~Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Aspart-PH20 (Treatment A): 100 U/mL insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
320317|NCT01194245|B4|Baseline|Aspart-PH20 First, Then Insulin Lispro|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.~Aspart-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
320318|NCT01194245|B3|Baseline|Insulin Lispro First, Then Lispro-PH20|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.~Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Lispro-PH20 (Treatment A): 100 U/mL insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
320319|NCT01194245|B2|Baseline|Lispro-PH20 First, Then Insulin Lispro|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.~Lispro-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
320320|NCT01194245|B1|Baseline|Non-randomized Participants|"Participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually. Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.~Participants did not complete the titration period or did not meet one or more randomization criteria and, therefore, were not randomized."
320321|NCT01194245|P5|Participant Flow|Insulin Lispro First, Then Aspart-PH20|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.~Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Aspart-PH20 (Treatment A): 100 U/mL insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
320322|NCT01194245|P4|Participant Flow|Aspart-PH20 First, Then Insulin Lispro|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.~Aspart-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
320323|NCT01194245|P3|Participant Flow|Insulin Lispro First, Then Lispro-PH20|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.~Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Lispro-PH20 (Treatment A): 100 U/mL insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
320324|NCT01194245|P2|Participant Flow|Lispro-PH20 First, Then Insulin Lispro|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.~Lispro-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
320325|NCT01194245|P1|Participant Flow|All Enrolled Participants|"Prior to randomization, all enrolled participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually.~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
320326|NCT01194245|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
320327|NCT01194245|O1|Outcome|Analog-PH20|100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
320328|NCT01194245|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
320329|NCT01194245|O1|Outcome|Analog-PH20|100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
320330|NCT01194245|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
320331|NCT01194245|O1|Outcome|Analog-PH20|100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
320332|NCT01194245|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
320333|NCT01194245|O1|Outcome|Analog-PH20|100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
320334|NCT01194245|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
320335|NCT01194245|O1|Outcome|Analog-PH20|100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
320336|NCT01194245|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
320337|NCT01194245|O1|Outcome|Analog-PH20|100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
320338|NCT01194245|E5|Reported Event|Insulin Lispro (Aspart-PH20 Cohort) Treatment Period|"Participants were randomized to the Aspart-PH20 cohort.~100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
320339|NCT01194245|E4|Reported Event|Aspart-PH20 Treatment Period|"100 units per milliliter (U/mL) insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
320340|NCT01194245|E3|Reported Event|Insulin Lispro (Lispro-PH20 Cohort) Treatment Period|"Participants were randomized to the Lispro-PH20 cohort.~100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
320341|NCT01194245|E2|Reported Event|Lispro-PH20 Treatment Period|"100 units per milliliter (U/mL) insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
320342|NCT01194245|E1|Reported Event|Titration Period (All Enrolled Participants)|"Prior to randomization, all enrolled participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually.~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
320343|NCT01194219|B3|Baseline|Total|Total of all reporting groups
320344|NCT01194219|B2|Baseline|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
320437|NCT01193920|P4|Participant Flow|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
320345|NCT01194219|B1|Baseline|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
320346|NCT01194219|P10|Participant Flow|Placebo-Apremilast (Long-term Extension)|Participants who were initially randomized to identically matching placebo BID during the placebo-controlled phase (Weeks 0-16) were switched after 16 weeks of treatment to apremilast 30 mg tablets BID and continued dosing with apremilast 30 mg BID during the Maintenance Phase (Weeks 16-32) and Randomized Withdrawal Phase were eligible to participate in the Long-term Extension phase from Weeks 52-260 and continued on apremilast 30 mg tablets BID for the remainder of their participation.
320347|NCT01194219|P9|Participant Flow|Apremilast (Long-term Extension)|Participants who were initially randomized to APR 30 mg BID during the 16-week placebo-controlled phase (Weeks 0-16) continued receiving APR 30 mg BID through the Maintenance Phase (Weeks 16-32) and were re-randomized to APR 30 mg tablets or placebo tablets BID during the Randomized Withdrawal Phase; participants were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and received APR 30 mg BID for the remainder of their participation.
320348|NCT01194219|P8|Participant Flow|PBO-APR-APR + Optional Topicals/ UVB|Participants who were initially randomized to placebo BID during the 16-week Placebo-controlled Phase (Weeks 0-16) were switched after 16 weeks of treatment to APR 30 mg BID and continued dosing with APR 30 mg BID during the Maintenance Phase (Weeks 16-32). At week 32, all participants continued to receive APR 30mg BID. Those participants who were considered partial responders (ie, having a response of PASI-50 to PASI-74) or non-responders (ie, having a response of < PASI-50) were given the option of adding topical therapies and/or phototherapy to their regimen. A subset of these partial or non-responders received additional topical or phototherapy. All participants who completed the Randomized Withdrawal Phase at week 52 were eligible to participate in the Long-term Extension Phase from weeks 52-260 and remained on APR 30 mg BID for the remainder of their participation.
320349|NCT01194219|P7|Participant Flow|APR-APR-APR + Optional Topicals/UVB|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase (Weeks 0-16) continued dosing with APR 30 mg BID through the Maintenance Phase (Weeks 16-32). At week 32, those participants who were considered partial responders (ie, having a response of PASI-50 to PASI-74) and non-responders (ie, having a response of <PASI-50), remained on APR 30 mg BID and were given the option of adding topical therapies and/or phototherapy to their regimen. Those participants who completed the Randomized Withdrawal Phase at week 52 were eligible to participate in the Long-term Extension Phase from weeks 52-260 and remained on APR 30 mg BID for the remainder of their participation.
320350|NCT01194219|P6|Participant Flow|APR-APR-Re-randomized to APR|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase (Weeks 0-16) continued dosing with APR 30 mg BID through the Maintenance Phase (Weeks 16-32). At Week 32, those participants who were considered responders (ie, having a ≥PASI-75 response) were re-randomized to APR 30 mg BID during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from weeks 52-260 and remained on APR 30 mg BID for the remainder of their participation.
320351|NCT01194219|P5|Participant Flow|APR-APR-Re-randomized to PBO|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase (Weeks 0-16) continued dosing with APR 30 mg BID through the Maintenance Phase (Weeks 16-32). At Week 32, those participants who were considered responders [ie, having a ≥ Psoriasis Area and Severity Index score of 75 (PASI-75) response] were re-randomized to PBO during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who retained their ≥PASI-75 response through the Randomized Withdrawal Phase remained on PBO until week 52. Those participants who lost their PASI-75 improvement achieved at week 32, were switched back to APR 30 mg BID at the time loss of effect was observed. All participants who completed the Randomized Withdrawal Phase at week 52 were eligible to participate in the Long-term Extension Phase from weeks 52-260, and received APR 30 mg BID for the remainder of their participation.
320352|NCT01194219|P4|Participant Flow|Placebo-Apremilast|Participants who were initially randomized to identically matching placebo tablets BID during the Placebo-controlled Phase (Weeks 0-16) were switched after 16 weeks of treatment to apremilast 30 mg tablets BID and continued dosing with apremilast 30 mg BID during the Maintenance Phase (Weeks 16-32)
320353|NCT01194219|P3|Participant Flow|Apremilast-Apremilast|Participants who were initially randomized to APR 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16) remained on APR 30 mg BID during the Maintenance Phase (Weeks 16-32).
320354|NCT01194219|P2|Participant Flow|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
320355|NCT01194219|P1|Participant Flow|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
320356|NCT01194219|O1|Outcome|Apremilast|Participants initially randomized to placebo or apremilast 30 mg tablets BID during the 16-week placebo-controlled phase (Weeks 0-16) continued to receive apremilast 30 mg BID through the maintenance phase; during the randomized withdrawal phase (Weeks 32-52) participants continued to receive apremilast 30 mg BID or were again randomized to either apremilast 30 mg BID or placebo and were transitioned to apremilast 30 mg BID after loss of response or in the long-term extension phase from Weeks 52-260
320357|NCT01194219|O2|Outcome|Apremilast|Participants were initially randomized to apremilast 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16)
320358|NCT01194219|O1|Outcome|Placebo|Participants were initially randomized to placebo tablets BID during the Placebo-controlled Phase (Weeks 0-16)
320359|NCT01194219|O1|Outcome|Apremilast|Participants initially randomized to placebo or apremilast 30 mg tablets BID during the 16-week placebo-controlled phase (Weeks 0-16) continued to receive apremilast 30 mg BID through the maintenance phase; during the randomized withdrawal phase (Weeks 32-52) participants continued to receive apremilast 30 mg BID or were again randomized to either apremilast 30 mg BID or placebo and were transitioned to apremilast 30 mg BID after loss of response or in the long-term extension phase from Weeks 52-260,
320360|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo tablets BID during the Placebo-controlled Phase (weeks 0-16)
320361|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
320535|NCT01193686|O2|Outcome|Recipients of PV|
320536|NCT01193686|O1|Outcome|Veteran Peer Visitors|
320362|NCT01194219|O2|Outcome|APR-APR -Re-randomized to PBO|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (weeks 16-32). At Week 32, those participants who were considered responders (ie, having a ≥PASI-75 response) were re-randomized to PBO during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who retained their ≥PASI-75 response through the Randomized Withdrawal Phase remained on PBO until Week 52. Those participants who lost their PASI-75 improvement achieved at Week 32, were switched back to APR 30 mg BID at the time loss of effect was observed.
320363|NCT01194219|O1|Outcome|APR-APR-Re-randomized to APR|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase (Weeks 0-16) continued dosing with APR 30 mg BID through the Maintenance Phase (Weeks 16-32). At Week 32, those participants who were considered responders (ie, having a ≥PASI-75 response) were re-randomized to APR 30 mg BID during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from weeks 52-260 and remained on APR 30 mg BID for the remainder of their participation.
320364|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (Weeks 0-16)
320365|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
320366|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16).
320367|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
320368|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16)
320369|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
320370|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16)
320371|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
320372|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
320373|NCT01194219|O1|Outcome|Placebo/Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
320374|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
320375|NCT01194219|O1|Outcome|Placebo/Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
320376|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16)
320377|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
320378|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
320379|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast 30mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
320380|NCT01194219|O2|Outcome|Placebo (PBO)|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
320381|NCT01194219|O1|Outcome|Placebo/Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
320382|NCT01194219|E4|Reported Event|Apremilast (Apremilast Exposure Period) Weeks 0-260|Participants who received apremilast 30 mg tablets BID, regardless of when the apremilast exposure started (at Week 0 or at week 16), up until Week 260. Adverse events associated with apremilast treatment up to Week 260 were included. AEs that started more than 28 days after Placebo treatment and prior to resuming apremilast were excluded for participants who were re-randomized to Placebo at Week 32.
320383|NCT01194219|E3|Reported Event|APR-APR-PBO Randomized Withdrawal Phase Weeks 32-52|Participants re-randomized and received placebo tablets BID at Week 32. Data from Week 32 up to Week 52 when participants received placebo treatment.
320384|NCT01194219|E2|Reported Event|Apremilast (Placebo-Controlled Phase) Weeks 0-16|Participants randomized and received apremilast 30 mg tablets BID during the Placebo-Controlled Phase (Weeks 0-16)
320385|NCT01194219|E1|Reported Event|Placebo (Placebo-Controlled Phase) Weeks 0-16|Participants randomized and received identically matching placebo tablets BID during the Placebo-controlled Phase (Weeks 0-16)
320386|NCT01194154|B3|Baseline|Total|Total of all reporting groups
320387|NCT01194154|B2|Baseline|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
320388|NCT01194154|B1|Baseline|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
320389|NCT01194154|P2|Participant Flow|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
320390|NCT01194154|P1|Participant Flow|Mircera|Methoxy polyethylene glycol-epoetin beta 30 microgram (mcg) subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 gram (g)/ deciliter (dL).
320391|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
320392|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 microgram (mcg) subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 gram (g)/ deciliter (dL).
320393|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
320394|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/ dL.
320395|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
320396|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 microgram (mcg) subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 gram (g)/ deciliter (dL).
320397|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
320398|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
320399|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
320400|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
320401|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
320402|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
320403|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
320404|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
320405|NCT01194154|E2|Reported Event|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
320406|NCT01194154|E1|Reported Event|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
320407|NCT01194089|B3|Baseline|Total|Total of all reporting groups
320408|NCT01194089|B2|Baseline|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
320409|NCT01194089|B1|Baseline|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
320410|NCT01194089|P2|Participant Flow|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
320411|NCT01194089|P1|Participant Flow|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
320412|NCT01194089|O2|Outcome|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
320413|NCT01194089|O1|Outcome|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
320414|NCT01194089|O2|Outcome|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
320415|NCT01194089|O1|Outcome|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
320416|NCT01194089|O2|Outcome|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
320417|NCT01194089|O1|Outcome|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
320418|NCT01194089|E2|Reported Event|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
320419|NCT01194089|E1|Reported Event|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
320420|NCT01193920|B11|Baseline|Total|Total of all reporting groups
320421|NCT01193920|B10|Baseline|Infants / Placebo|Infants born from women who received one injection of saline solution
320422|NCT01193920|B9|Baseline|Infants 5/5/5 μg|Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
320423|NCT01193920|B8|Baseline|Infants 2.5/2.5/2.5 μg|Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
320424|NCT01193920|B7|Baseline|Infants 0.5/0.5/0.5 μg|Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
320425|NCT01193920|B6|Baseline|Pregnant/Placebo|Pregnant women who received one injection of saline solution
320426|NCT01193920|B5|Baseline|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
320427|NCT01193920|B4|Baseline|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
320428|NCT01193920|B3|Baseline|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
320429|NCT01193920|B2|Baseline|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
320430|NCT01193920|B1|Baseline|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
320431|NCT01193920|P10|Participant Flow|Infants / Placebo|Infants born from women who received saline solution
320432|NCT01193920|P9|Participant Flow|Infants 5/5/5 μg|Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
320433|NCT01193920|P8|Participant Flow|Infants 2.5/2.5/2.5 μg|Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
320434|NCT01193920|P7|Participant Flow|Infants 0.5/0.5/0.5 μg|Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
320435|NCT01193920|P6|Participant Flow|Pregnant/Placebo|Pregnant women who received one injection of saline solution
320436|NCT01193920|P5|Participant Flow|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
320537|NCT01193686|O2|Outcome|Recipients of PV|
320538|NCT01193686|O1|Outcome|Veteran Peer Visitors|
320438|NCT01193920|P3|Participant Flow|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
320439|NCT01193920|P2|Participant Flow|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
320440|NCT01193920|P1|Participant Flow|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
320441|NCT01193920|O4|Outcome|Infants / Placebo|Infants born from women who received saline solution
320442|NCT01193920|O3|Outcome|Infants 5/5/5 μg|Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
320443|NCT01193920|O2|Outcome|Infants 2.5/2.5/2.5 μg|Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
320444|NCT01193920|O1|Outcome|Infants 0.5/0.5/0.5 μg|Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
320445|NCT01193920|O4|Outcome|Infants / Placebo|Infants born from women who received saline solution
320446|NCT01193920|O3|Outcome|Infants 5/5/5 μg|Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
320447|NCT01193920|O2|Outcome|Infants 2.5/2.5/2.5 μg|Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
320448|NCT01193920|O1|Outcome|Infants 0.5/0.5/0.5 μg|Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
320449|NCT01193920|O4|Outcome|Pregnant/Placebo|Pregnant women who received one injection of saline solution
320450|NCT01193920|O3|Outcome|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
320451|NCT01193920|O2|Outcome|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
320452|NCT01193920|O1|Outcome|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
320453|NCT01193920|O2|Outcome|Non Pregnant/Placebo|Non pregnant women received two injections of saline solution
320454|NCT01193920|O1|Outcome|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
320455|NCT01193920|O2|Outcome|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
320456|NCT01193920|O1|Outcome|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
320457|NCT01193920|O2|Outcome|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
320458|NCT01193920|O1|Outcome|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
320459|NCT01193920|O4|Outcome|Pregnant/Placebo|Pregnant women who received one injection of saline solution
320460|NCT01193920|O3|Outcome|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
320461|NCT01193920|O2|Outcome|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
320462|NCT01193920|O1|Outcome|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
320463|NCT01193920|O4|Outcome|Pregnant/Placebo|Pregnant women who received one injection of saline solution
320464|NCT01193920|O3|Outcome|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
320465|NCT01193920|O2|Outcome|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
320466|NCT01193920|O1|Outcome|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
320467|NCT01193920|O4|Outcome|Pregnant/Placebo|Pregnant women who received one injection of saline solution
320468|NCT01193920|O3|Outcome|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
320469|NCT01193920|O2|Outcome|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
320470|NCT01193920|O1|Outcome|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
320471|NCT01193920|O4|Outcome|Pregnant/Placebo|Pregnant women who received one injection of saline solution
320472|NCT01193920|O3|Outcome|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
320473|NCT01193920|O2|Outcome|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
320474|NCT01193920|O1|Outcome|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
320475|NCT01193920|O2|Outcome|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
320476|NCT01193920|O1|Outcome|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
320477|NCT01193920|O2|Outcome|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
320478|NCT01193920|O1|Outcome|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
320479|NCT01193920|E10|Reported Event|Infants / Placebo|Infants born from women who received one injection of saline solution
320480|NCT01193920|E9|Reported Event|Infants 5/5/5 μg|Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
320481|NCT01193920|E8|Reported Event|Infants 2.5/2.5/2.5 μg|Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
320482|NCT01193920|E7|Reported Event|Infants 0.5/0.5/0.5 μg|Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
320483|NCT01193920|E6|Reported Event|Pregnant/Placebo|Pregnant women who received one injection of saline solution
320484|NCT01193920|E5|Reported Event|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
320485|NCT01193920|E4|Reported Event|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
320486|NCT01193920|E3|Reported Event|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
320487|NCT01193920|E2|Reported Event|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
320488|NCT01193920|E1|Reported Event|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
320489|NCT01193907|B5|Baseline|Total|Total of all reporting groups
320490|NCT01193907|B4|Baseline|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
320491|NCT01193907|B3|Baseline|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
320492|NCT01193907|B2|Baseline|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
320493|NCT01193907|B1|Baseline|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
320494|NCT01193907|P4|Participant Flow|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
320495|NCT01193907|P3|Participant Flow|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
320496|NCT01193907|P2|Participant Flow|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
320497|NCT01193907|P1|Participant Flow|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
320498|NCT01193907|O4|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
320499|NCT01193907|O3|Outcome|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
320500|NCT01193907|O2|Outcome|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
320501|NCT01193907|O1|Outcome|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
320502|NCT01193907|O4|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
320503|NCT01193907|O3|Outcome|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
320504|NCT01193907|O2|Outcome|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
320505|NCT01193907|O1|Outcome|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
320506|NCT01193907|O4|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
320507|NCT01193907|O3|Outcome|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
320508|NCT01193907|O2|Outcome|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
320509|NCT01193907|O1|Outcome|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
320510|NCT01193907|O4|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
320511|NCT01193907|O3|Outcome|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
320512|NCT01193907|O2|Outcome|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
320513|NCT01193907|O1|Outcome|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
320514|NCT01193907|E4|Reported Event|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
320515|NCT01193907|E3|Reported Event|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
320516|NCT01193907|E2|Reported Event|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
320517|NCT01193907|E1|Reported Event|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
320518|NCT01193868|B1|Baseline|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
320519|NCT01193868|P1|Participant Flow|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
320520|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
320521|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
320522|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
320523|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
320524|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
320525|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
320526|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
320527|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
320528|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
320529|NCT01193868|E1|Reported Event|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
320530|NCT01193686|B3|Baseline|Total|Total of all reporting groups
320531|NCT01193686|B2|Baseline|Recipients of Peer Visitors|Veterans who seved in Operation Iraqi Freedom or Operation Enduring Freedom, sustained polytrauma injuries, and were initiating rehabilitation therapies.
320532|NCT01193686|B1|Baseline|Veteran Peer Visitors|Veterans who seved in Operation Iraqi Freedom or Operation Enduring Freedom, sustained polytrauma injuries, and successfully completed rehabiliation were recruited for training as peer mentors.
320533|NCT01193686|P2|Participant Flow|Recipients of PV|9 Veterans receiving care at a Polytrauma Network Site (of over 300 seen during the study period) expressed interest in meeting with a Veteran Peer Mentor. Of these 8 completed visits and all study requirements. One withdrew for non-study-related reasons.
320534|NCT01193686|P1|Participant Flow|Veteran Peer Visitors|Of the 15 (52%) PV who enrolled in the study and completed the baseline assessment, 4 (27%) withdrew prior to PV training due to moving out of state (3) or schedule limitations (n=1). One was removed from the study by investigators due to discovery of invalid reporting.
320543|NCT01193686|O2|Outcome|Recipients of PV|9 Veterans receiving care at a Polytrauma Network Site (of over 300 seen during the study period) expressed interest in meeting with a Veteran Peer Mentor. Of these 8 completed visits and all study requirements. One withdrew for non-study-related reasons.
320544|NCT01193686|O1|Outcome|Veteran Peer Visitors|
320545|NCT01193686|E2|Reported Event|Recipients of Veteran Peer Visitation|Veterans of Operation Enduring Freedom or Operation Iraqi Freedom who sustained polytrauma (i.e., mutiple systems involved) injuries.
320546|NCT01193686|E1|Reported Event|Veteran Peer Visitors|Veteran Peer Visitors (VPV) who participated in a 2-day training program and then provided at 1-5 visits to at least 2 recipients. All Peer Visitors had served in Operation Iraqi Freedom or Operation Enduring Freedom, sustained polytrauma injuries, and successfully completed rehabilitation.
320547|NCT01193660|B4|Baseline|Total|Total of all reporting groups
320548|NCT01193660|B3|Baseline|Only Rehabilitation|Active rehabilitation
320549|NCT01193660|B2|Baseline|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
320550|NCT01193660|B1|Baseline|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
320551|NCT01193660|P3|Participant Flow|Only Rehabilitation|Active rehabilitation
320552|NCT01193660|P2|Participant Flow|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
320553|NCT01193660|P1|Participant Flow|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
320554|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
320555|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
320556|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
320557|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
320558|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
320559|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
320560|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
320561|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
320562|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
320563|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
320564|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
320565|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
320566|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
320567|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
320568|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
320569|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
320570|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
320571|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
320572|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
320573|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
320574|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
320575|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
320576|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
320577|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
320578|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
320579|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
320580|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
320581|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
320582|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
320583|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
320584|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
320585|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
320586|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
320587|NCT01193660|E3|Reported Event|Only Rehabilitation|Active rehabilitation
320588|NCT01193660|E2|Reported Event|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
320589|NCT01193660|E1|Reported Event|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
320590|NCT01193608|B7|Baseline|Total|Total of all reporting groups
320591|NCT01193608|B6|Baseline|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320592|NCT01193608|B5|Baseline|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320593|NCT01193608|B4|Baseline|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320594|NCT01193608|B3|Baseline|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320595|NCT01193608|B2|Baseline|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320596|NCT01193608|B1|Baseline|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320597|NCT01193608|P6|Participant Flow|Placebo|Participants received placebo matched to AAB-003 1-hour IV infusion (infusion of placebo matched to AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.
320598|NCT01193608|P5|Participant Flow|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg 1-hour IV infusion (infusion of AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.
320599|NCT01193608|P4|Participant Flow|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg 1-hour IV infusion (infusion of AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.
320600|NCT01193608|P3|Participant Flow|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg 1-hour IV infusion (infusion of AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.
320601|NCT01193608|P2|Participant Flow|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg 1-hour IV infusion (infusion of AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.
320602|NCT01193608|P1|Participant Flow|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 milligram/kilogram (mg/kg) 1-hour intravenous (IV) infusion (infusion of AAB-003 and 20 milliliter (mL) normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.
320603|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320604|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320605|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320606|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320607|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320608|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320611|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320612|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320613|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320614|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320615|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320616|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320617|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320618|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320619|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320620|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320621|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320622|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320623|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320624|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320625|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320626|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320627|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320628|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320629|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320630|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320631|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320632|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320633|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320634|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320635|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320636|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320637|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320638|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320639|NCT01193608|O2|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320640|NCT01193608|O1|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320641|NCT01193608|O2|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320642|NCT01193608|O1|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320643|NCT01193608|O2|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320644|NCT01193608|O1|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320645|NCT01193608|O2|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320646|NCT01193608|O1|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320647|NCT01193608|O2|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320648|NCT01193608|O1|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320649|NCT01193608|O2|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320650|NCT01193608|O1|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320651|NCT01193608|O2|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320652|NCT01193608|O1|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320653|NCT01193608|O2|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320654|NCT01193608|O1|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320655|NCT01193608|O3|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320656|NCT01193608|O2|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320657|NCT01193608|O1|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320658|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320659|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320660|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320661|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320662|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320663|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320664|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320665|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320666|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320667|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320668|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320669|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320670|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320671|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320672|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320673|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320674|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320675|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320676|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320677|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320678|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320679|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320680|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320681|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320682|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320683|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320684|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320685|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320686|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320687|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320688|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320689|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320690|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320691|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320692|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320693|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320694|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320695|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320696|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320697|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320698|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320699|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320700|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320701|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320702|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320703|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320704|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320705|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320706|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320707|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320708|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320709|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320710|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320711|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320712|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320713|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320714|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320715|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320716|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320717|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320718|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320719|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320720|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320721|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320722|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320723|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320724|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320725|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320726|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320727|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320728|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320729|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320730|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320731|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320732|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320733|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320734|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320735|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320736|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320737|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320738|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320739|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320740|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320741|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320742|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320743|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320744|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320745|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320746|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320747|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320748|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320749|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320750|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320751|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320752|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320753|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320754|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320755|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320756|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320757|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320758|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320759|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320760|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320761|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320762|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320763|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
321542|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
320764|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320765|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320766|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320767|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320768|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320769|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320770|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320771|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320772|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320773|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320774|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320775|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320776|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320777|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320778|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320779|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320780|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320781|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320782|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320783|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320784|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320785|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320786|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320787|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320788|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320789|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320790|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320791|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320792|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320793|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320794|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320795|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320796|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320797|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320798|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320799|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320800|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320801|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320802|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320803|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320804|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320805|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320806|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320807|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320808|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320809|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320810|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320811|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320812|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320813|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320814|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320815|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320816|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320817|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320818|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320819|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320820|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320821|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320822|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320823|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320824|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320825|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320826|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320827|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320828|NCT01193608|E6|Reported Event|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
320829|NCT01193608|E5|Reported Event|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320830|NCT01193608|E4|Reported Event|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320831|NCT01193608|E3|Reported Event|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320832|NCT01193608|E2|Reported Event|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320833|NCT01193608|E1|Reported Event|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
320834|NCT01193582|B5|Baseline|Total|Total of all reporting groups
320835|NCT01193582|B4|Baseline|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar
320836|NCT01193582|B3|Baseline|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
320837|NCT01193582|B2|Baseline|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
320838|NCT01193582|B1|Baseline|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
320839|NCT01193582|P4|Participant Flow|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar
320840|NCT01193582|P3|Participant Flow|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
320841|NCT01193582|P2|Participant Flow|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
320842|NCT01193582|P1|Participant Flow|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
320843|NCT01193582|O4|Outcome|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
320844|NCT01193582|O3|Outcome|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
320845|NCT01193582|O2|Outcome|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
320846|NCT01193582|O1|Outcome|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
320847|NCT01193582|O4|Outcome|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
320848|NCT01193582|O3|Outcome|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
320849|NCT01193582|O2|Outcome|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
320850|NCT01193582|O1|Outcome|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
320851|NCT01193582|O1|Outcome|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
320852|NCT01193582|O1|Outcome|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
320853|NCT01193582|O1|Outcome|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
320854|NCT01193582|O1|Outcome|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
320855|NCT01193582|O1|Outcome|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
320856|NCT01193582|O1|Outcome|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
320857|NCT01193582|O4|Outcome|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
320858|NCT01193582|O3|Outcome|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
320859|NCT01193582|O2|Outcome|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
320860|NCT01193582|O1|Outcome|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
320861|NCT01193582|O4|Outcome|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
320862|NCT01193582|O3|Outcome|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
320863|NCT01193582|O2|Outcome|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
320864|NCT01193582|O1|Outcome|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
320865|NCT01193582|E4|Reported Event|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar
320866|NCT01193582|E3|Reported Event|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
320867|NCT01193582|E2|Reported Event|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
320868|NCT01193582|E1|Reported Event|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
320869|NCT01193556|B3|Baseline|Total|Total of all reporting groups
320870|NCT01193556|B2|Baseline|PlasmaBlade|The PEAK PlasmaBlade will be used for the tonsillectomy.
320871|NCT01193556|B1|Baseline|Standard of Care (SOC)|Traditional electrosurgery will be used for the tonsillectomy.
320872|NCT01193556|P2|Participant Flow|PlasmaBlade|The PEAK PlasmaBlade will be used for the tonsillectomy.
320873|NCT01193556|P1|Participant Flow|Standard of Care (SOC)|Traditional electrosurgery will be used for the tonsillectomy.
320874|NCT01193556|O2|Outcome|PlasmaBlade|The PEAK PlasmaBlade will be used for the tonsillectomy.
320875|NCT01193556|O1|Outcome|Standard of Care (SOC)|Traditional electrosurgery will be used for the tonsillectomy.
320876|NCT01193556|O2|Outcome|PlasmaBlade|The PEAK PlasmaBlade will be used for the tonsillectomy.
320877|NCT01193556|O1|Outcome|Standard of Care (SOC)|Traditional electrosurgery will be used for the tonsillectomy.
320878|NCT01193556|E2|Reported Event|PlasmaBlade|The PEAK PlasmaBlade will be used for the tonsillectomy.
320879|NCT01193556|E1|Reported Event|Standard of Care (SOC)|Traditional electrosurgery will be used for the tonsillectomy.
320880|NCT01193348|B1|Baseline|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
320881|NCT01193348|P1|Participant Flow|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
320882|NCT01193348|O1|Outcome|Eculizumab. Min and Max Blood Concentration|≥40kg weight cohort
320883|NCT01193348|O1|Outcome|Eculizumab. Min and Max Blood Concentration|30 – <40kg weight cohort
320884|NCT01193348|O1|Outcome|Eculizumab. Min and Max Blood Concentration|20 – <30kg weight cohort
320885|NCT01193348|O1|Outcome|Eculizumab. Min and Max Blood Concentration|10 – <20kg weight cohort
320886|NCT01193348|O1|Outcome|Eculizumab. Min and Max Blood Concentration|5 – <10kg weight cohort
320887|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
320888|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
320889|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
320890|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
320891|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
320892|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
320893|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
320894|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
320895|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
320896|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
320897|NCT01193348|E1|Reported Event|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
320898|NCT01193335|B3|Baseline|Total|Total of all reporting groups
320899|NCT01193335|B2|Baseline|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320900|NCT01193335|B1|Baseline|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320901|NCT01193335|P2|Participant Flow|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320902|NCT01193335|P1|Participant Flow|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320903|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320904|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320905|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320931|NCT01193335|O1|Outcome|13vPnC (Group 1A)|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320906|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320907|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320908|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320909|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320910|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320911|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320912|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320913|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320914|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320915|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320916|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320917|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320918|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320919|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320920|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320921|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320922|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320923|NCT01193335|O3|Outcome|13vPnC (Group 1C)|Preterm participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320924|NCT01193335|O2|Outcome|13vPnC (Group 1B)|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320925|NCT01193335|O1|Outcome|13vPnC (Group 1A)|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320926|NCT01193335|O3|Outcome|13vPnC (Group 1C)|Preterm participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320927|NCT01193335|O2|Outcome|13vPnC (Group 1B)|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320928|NCT01193335|O1|Outcome|13vPnC (Group 1A)|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320929|NCT01193335|O3|Outcome|13vPnC (Group 1C)|Preterm participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320930|NCT01193335|O2|Outcome|13vPnC (Group 1B)|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320932|NCT01193335|O3|Outcome|13vPnC (Group 1C)|Preterm participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320933|NCT01193335|O2|Outcome|13vPnC (Group 1B)|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320934|NCT01193335|O1|Outcome|13vPnC (Group 1A)|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320935|NCT01193335|O3|Outcome|13vPnC (Group 1C)|Preterm participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320936|NCT01193335|O2|Outcome|13vPnC (Group 1B)|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320937|NCT01193335|O1|Outcome|13vPnC (Group 1A)|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320938|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320939|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320940|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320941|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320942|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320943|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320944|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320945|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320946|NCT01193335|O3|Outcome|13vPnC (Group 1C)|Preterm infant participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320947|NCT01193335|O2|Outcome|13vPnC (Group 1B)|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320948|NCT01193335|O1|Outcome|13vPnC (Group 1A)|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320949|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320950|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320951|NCT01193335|O3|Outcome|13vPnC Group 1C|Preterm participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320952|NCT01193335|O2|Outcome|13vPnC Group 1B|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320953|NCT01193335|O1|Outcome|13vPnC Group 1A|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320954|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320955|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320956|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
321019|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
320957|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320958|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320959|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320960|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320961|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320962|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320963|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320964|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320965|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320966|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320967|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320968|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320969|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320970|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320971|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320972|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320973|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320974|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320975|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320976|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320977|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320978|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320979|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320980|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320981|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320982|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320983|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320984|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
320985|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
320986|NCT01193335|E10|Reported Event|13vPnC Group 2 (Term Infant) - 2 Year Follow-up|Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from 1-year follow-up after toddler dose to 2-year follow-up after toddler dose.
320987|NCT01193335|E9|Reported Event|13vPnC Group 1 (Preterm Infant) - 2 Year Follow-up|Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from 1-year follow-up after toddler dose to 2-year follow-up after toddler dose.
320988|NCT01193335|E8|Reported Event|13vPnC Group 2 (Term Infant) - 1 Year Follow-up|Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from blood draw 1 month after the toddler dose to 1-year follow-up.
320989|NCT01193335|E7|Reported Event|13vPnC Group 1 (Preterm Infant) - 1 Year Follow-up|Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from blood draw 1 month after the toddler dose to 1-year follow-up.
320990|NCT01193335|E6|Reported Event|13vPnC Group 2 (Term Infant) - Toddler Dose|Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after toddler dose.
320991|NCT01193335|E5|Reported Event|13vPnC Group 1 (Preterm Infant) - Toddler Dose|Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after toddler dose.
320992|NCT01193335|E4|Reported Event|13vPnC Group 2 (Term Infant) - After Infant Series|Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series), assessed from blood draw 1 month after infant Dose 3 to before toddler dose.
320993|NCT01193335|E3|Reported Event|13vPnC Group 1 (Preterm Infant) - After Infant Series|Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3 and 4 months of age (infant series), assessed from blood draw 1 month after infant Dose 3 to before toddler dose.
320994|NCT01193335|E2|Reported Event|13vPnC Group 2 (Term Infant) - Infant Series|Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series), assessed from Infant Dose 1 through the blood draw 1 month after Infant Dose 3.
320995|NCT01193335|E1|Reported Event|13vPnC Group 1 (Preterm Infant) - Infant Series|Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3 and 4 months of age (infant series), assessed from Infant Dose 1 through the blood draw 1 month after Infant Dose 3.
320996|NCT01193283|B1|Baseline|SAA Hematologic Response|"Treatment-naive severe aplastic anemia patients will receive a low dose of cyclophosphamide (120mg/kg) and low dose cyclosporine ( target therapeutic level of 100-200 micrograms per liter). Cyclophosphamide will be given once daily for 4 doses. Cyclosporine will be started after cyclophosphamide completion, cyclosporine will be given twice daily. The dosing will be modified to attain the therapeutic level.~Cyclophosphamide: 30 my/kg for 4 days~Cyclosporine: daily to a trough of 100 t0 200 ng/ml"
321543|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
320997|NCT01193283|P1|Participant Flow|SAA Hematologic Response|"Treatment-naive severe aplastic anemia patients will receive a low dose of cyclophosphamide (120mg/kg) and low dose cyclosporine ( target therapeutic level of 100-200 micrograms per liter). Cyclophosphamide will be given once daily for 4 doses. Cyclosporine will be started after cyclophosphamide completion, cyclosporine will be given twice daily. The dosing will be modified to attain the therapeutic level.~Cyclophosphamide: 30 my/kg for 4 days~Cyclosporine: daily to a trough of 100 t0 200 ng/ml"
320998|NCT01193283|O1|Outcome|SAA Hematologic Response|"Treatment-naive severe aplastic anemia patients will receive a low dose of cyclophosphamide (120mg/kg) and low dose cyclosporine ( target therapeutic level of 100-200 micrograms per liter). Cyclophosphamide will be given once daily for 4 doses. Cyclosporine will be started after cyclophosphamide completion, cyclosporine will be given twice daily. The dosing will be modified to attain the therapeutic level.~Cyclophosphamide: 30 my/kg for 4 days~Cyclosporine: daily to a trough of 100 t0 200 ng/ml"
320999|NCT01193283|E1|Reported Event|SAA Hematologic Response|"Treatment-naive severe aplastic anemia patients will receive a low dose of cyclophosphamide (120mg/kg) and low dose cyclosporine ( target therapeutic level of 100-200 micrograms per liter). Cyclophosphamide will be given once daily for 4 doses. Cyclosporine will be started after cyclophosphamide completion, cyclosporine will be given twice daily. The dosing will be modified to attain the therapeutic level.~Cyclophosphamide: 30 my/kg for 4 days~Cyclosporine: daily to a trough of 100 t0 200 ng/ml"
321000|NCT01193244|B3|Baseline|Total|Total of all reporting groups
321001|NCT01193244|B2|Baseline|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321002|NCT01193244|B1|Baseline|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321003|NCT01193244|P2|Participant Flow|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321004|NCT01193244|P1|Participant Flow|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321005|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321006|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321007|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321008|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321009|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321010|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321011|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321012|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321013|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321014|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321015|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321016|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321017|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321018|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321020|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321021|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321022|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321023|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321024|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321025|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321026|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321027|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321028|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321029|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321030|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321031|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321032|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321033|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321034|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321035|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321036|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321037|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321038|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321039|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321040|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321041|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321042|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321079|NCT01193218|O3|Outcome|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
321043|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321044|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321045|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321046|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321047|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321048|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321049|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321050|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321051|NCT01193244|E2|Reported Event|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321052|NCT01193244|E1|Reported Event|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
321053|NCT01193218|B6|Baseline|Total|Total of all reporting groups
321054|NCT01193218|B5|Baseline|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
321055|NCT01193218|B4|Baseline|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
321056|NCT01193218|B3|Baseline|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
321057|NCT01193218|B2|Baseline|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
321058|NCT01193218|B1|Baseline|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
321059|NCT01193218|P8|Participant Flow|Empa 50 mg/25 mg|It is actually N/A in the 12-week first treatment period, and empagliflozin 50 mg/25 mg once daily group in the 40-week second treatment period
321060|NCT01193218|P7|Participant Flow|Empa 50mg\10mg|It is actually empagliflozin 50 mg once daily group in the 12-week first treatment period, and empagliflozin 50 mg/10 mg once daily group in the 40-week second treatment period
321061|NCT01193218|P6|Participant Flow|Empa 25mg|Empagliflozin 25 mg once daily group both in the 12-week first treatment period and the 40-week second treatment period
321062|NCT01193218|P5|Participant Flow|Empa 10mg|Empagliflozin 10 mg once daily group both in the 12-week first treatment period and the 40-week second treatment period
321063|NCT01193218|P4|Participant Flow|Empa 5 mg/25 mg|It is actually N/A in the 12-week first treatment period, and empagliflozin 5 mg/25 mg once daily group in the 40-week second treatment period
321064|NCT01193218|P3|Participant Flow|Empa 5mg/10mg|It is actually empagliflozin 5 mg once daily group in the 12-week first treatment period, and empagliflozin 5 mg/25 mg once daily group in the 40-week second treatment period
321065|NCT01193218|P2|Participant Flow|Placebo/Empa 25 mg|It is actually N/A in the 12-week first treatment period, and placebo/empagliflozin 25 mg once daily group in the 40-week second treatment period
321066|NCT01193218|P1|Participant Flow|Placebo/Empa 10mg|It is actually placebo once daily group in the 12-week first treatment period, and placebo/empagliflozin 10 mg once daily group in the 40-week second treatment period
321067|NCT01193218|O5|Outcome|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
321068|NCT01193218|O4|Outcome|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
321069|NCT01193218|O3|Outcome|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
321070|NCT01193218|O2|Outcome|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
321071|NCT01193218|O1|Outcome|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
321072|NCT01193218|O5|Outcome|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
321073|NCT01193218|O4|Outcome|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
321074|NCT01193218|O3|Outcome|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
321075|NCT01193218|O2|Outcome|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
321076|NCT01193218|O1|Outcome|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
321077|NCT01193218|O5|Outcome|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
321078|NCT01193218|O4|Outcome|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
321080|NCT01193218|O2|Outcome|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
321081|NCT01193218|O1|Outcome|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
321082|NCT01193218|O5|Outcome|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
321083|NCT01193218|O4|Outcome|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
321084|NCT01193218|O3|Outcome|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
321085|NCT01193218|O2|Outcome|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
321086|NCT01193218|O1|Outcome|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
321087|NCT01193218|E9|Reported Event|Empa 25mg (With at Least One Dose, 52 Week)|Patients with at least one dose of empagliflozin 25 mg once daily for 52−week treatment
321088|NCT01193218|E8|Reported Event|Empa 10mg (With at Least One Dose, 52 Week)|Patients with at least one dose of empagliflozin 10 mg once daily for 52−week treatment
321089|NCT01193218|E7|Reported Event|Empa 25mg (Randomized, 52 Week)|Patients randomized to empagliflozin 25 mg once daily for 52 weeks
321090|NCT01193218|E6|Reported Event|Empa 10mg (Randomized, 52 Week)|Patients randomized to empagliflozin 10mg once daily for 52 weeks
321091|NCT01193218|E5|Reported Event|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
321092|NCT01193218|E4|Reported Event|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
321093|NCT01193218|E3|Reported Event|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
321094|NCT01193218|E2|Reported Event|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
321095|NCT01193218|E1|Reported Event|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
321096|NCT01193153|B1|Baseline|Entire Study Population|Included all participants who received at least 1 dose of paliperidone palmitate in open-label lead in period.
321097|NCT01193153|P2|Participant Flow|Placebo|Participants did not receive placebo during OL lead in period and OL stabilization period. Participants received matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks during double-blind relapse prevention period.
321098|NCT01193153|P1|Participant Flow|Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks. Participants who completed stabilization period and maintained stabilization criteria throughout 12 weeks entered double- bind (DB) relapse prevention period. DB Relapse prevention period (15 months): Same dose as Day 92 once every 4 weeks until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
321099|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
321100|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
321101|NCT01193153|O2|Outcome|Placebo|Participants did not receive placebo during open-label lead in period and open-label stabilization period.
321102|NCT01193153|O1|Outcome|Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
321103|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
321104|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
321105|NCT01193153|O2|Outcome|Placebo|Participants did not receive placebo during open-label lead in period and open-label stabilization period.
321106|NCT01193153|O1|Outcome|Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
321107|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
321179|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321180|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321108|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
321109|NCT01193153|O2|Outcome|Placebo|Participants did not receive placebo during open-label lead in period and open-label stabilization period.
321110|NCT01193153|O1|Outcome|Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
321111|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
321112|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
321113|NCT01193153|O2|Outcome|Placebo|Participants did not receive placebo during open-label lead in period and open-label stabilization period.
321114|NCT01193153|O1|Outcome|Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
321115|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
321116|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
321117|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
321118|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
321119|NCT01193153|O2|Outcome|Placebo|Participants did not receive placebo during open-label lead in period and open-label stabilization period.
321120|NCT01193153|O1|Outcome|Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
321121|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
321122|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
321123|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
321124|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
321125|NCT01193153|E3|Reported Event|Double Blind - Placebo|Participants did not receive placebo during OL lead in period and OL stabilization period. Participants received matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants during DB relapse prevention period.
321126|NCT01193153|E2|Reported Event|Double Blind - Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
321181|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321127|NCT01193153|E1|Reported Event|Open Label - Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who completed stabilization period and maintained stabilization criteria throughout 12 weeks entered double- bind (DB) relapse prevention period.
321128|NCT01193127|B5|Baseline|Total|Total of all reporting groups
321129|NCT01193127|B4|Baseline|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321130|NCT01193127|B3|Baseline|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321131|NCT01193127|B2|Baseline|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321132|NCT01193127|B1|Baseline|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321133|NCT01193127|P4|Participant Flow|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321134|NCT01193127|P3|Participant Flow|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321135|NCT01193127|P2|Participant Flow|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321136|NCT01193127|P1|Participant Flow|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321137|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321138|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321139|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321140|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321141|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321142|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321143|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321144|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321145|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321146|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321147|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321148|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321149|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321150|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321151|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321152|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321153|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321154|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321155|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321156|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321157|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321158|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321159|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321160|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321161|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321162|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321163|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321164|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321165|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321166|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321167|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321168|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321169|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321170|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321171|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321172|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321173|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321174|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321175|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321176|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321177|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321178|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321182|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321183|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321184|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321185|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321186|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321187|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321188|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321189|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321190|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321191|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321192|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321193|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321194|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321195|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321196|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321197|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321198|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321199|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321200|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321201|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321202|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321203|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321204|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321205|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321206|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321207|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321208|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321209|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321210|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321211|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321212|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321213|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321214|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321215|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321216|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321217|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321218|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321219|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321220|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321221|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321222|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321223|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321224|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321225|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321226|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321227|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321228|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321229|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321230|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321231|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321232|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321233|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321234|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321235|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321236|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321237|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321238|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321239|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321240|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321241|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321242|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321243|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321244|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321245|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321246|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321247|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321248|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321249|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321250|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321251|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321252|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321253|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321254|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321255|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321256|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321257|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321258|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321259|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321260|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321261|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321262|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321263|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321264|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321265|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321266|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321267|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321268|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321269|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321270|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321271|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321272|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321273|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321274|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321275|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321276|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321277|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321278|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321279|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321280|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321281|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321282|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321283|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321284|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321285|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321286|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321287|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321288|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321289|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321290|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321291|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321292|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321293|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321294|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321295|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321296|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321297|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321298|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321299|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321300|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321301|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321302|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321303|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321304|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS) Solution|"Balanced Salt Solution (BSS) Solution~Balanced Salt Solution (BSS) Solution"
321305|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321306|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321307|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321308|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS) Solution|"Balanced Salt Solution (BSS) Solution~Balanced Salt Solution (BSS) Solution"
321309|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321310|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321311|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321312|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321313|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321314|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321315|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321316|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321317|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321318|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321319|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321320|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321321|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321322|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321323|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321324|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321325|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321326|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321327|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321328|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321329|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321330|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321331|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321332|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321333|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321334|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321335|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321336|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321337|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321338|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321339|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321340|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321341|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321342|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321343|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321344|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321345|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321346|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321347|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321348|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321349|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321350|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321351|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321352|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321353|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321354|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321355|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321356|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321357|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321358|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321359|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321360|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321361|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321362|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321363|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321364|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321365|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321366|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321367|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321368|NCT01193127|O1|Outcome|Solution|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321369|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321370|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321371|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321372|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321373|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321374|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321375|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321376|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321377|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321378|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321379|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321380|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321381|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321382|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321383|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321384|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321385|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321386|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321387|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321388|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321389|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321390|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321391|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321392|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321393|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321394|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321395|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321396|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321397|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321398|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321399|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321400|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321401|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321402|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321403|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321404|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321405|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321406|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321407|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321408|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321409|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321410|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321411|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321412|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321414|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321415|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321416|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321417|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321418|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321419|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321420|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321421|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321422|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321423|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321424|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321425|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321426|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321427|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321428|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321429|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321430|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321431|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321432|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321433|NCT01193127|E4|Reported Event|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
321434|NCT01193127|E3|Reported Event|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
321435|NCT01193127|E2|Reported Event|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
321436|NCT01193127|E1|Reported Event|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
321437|NCT01193114|B3|Baseline|Total|Total of all reporting groups
321438|NCT01193114|B2|Baseline|Treatment as Usual|The Mothers were offered services provided through the family shelter.
321439|NCT01193114|B1|Baseline|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
321440|NCT01193114|P2|Participant Flow|Treatment as Usual|The Mothers were offered services provided through the family shelter.
321441|NCT01193114|P1|Participant Flow|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
321442|NCT01193114|O2|Outcome|Treatment as Usual|The Mothers were offered services provided through the family shelter.
321443|NCT01193114|O1|Outcome|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
321444|NCT01193114|O2|Outcome|Treatment as Usual|The Mothers were offered services provided through the family shelter.
321445|NCT01193114|O1|Outcome|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
321446|NCT01193114|O2|Outcome|Treatment as Usual|The Mothers were offered services provided through the family shelter.
321447|NCT01193114|O1|Outcome|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
321448|NCT01193114|O2|Outcome|Treatment as Usual|The Mothers were offered services provided through the family shelter.
321449|NCT01193114|O1|Outcome|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
321450|NCT01193114|O2|Outcome|Treatment as Usual|The Mothers were offered services provided through the family shelter.
321451|NCT01193114|O1|Outcome|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
321452|NCT01193114|O2|Outcome|Treatment as Usual|The Mothers were offered services provided through the family shelter.
321453|NCT01193114|O1|Outcome|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
321454|NCT01193114|E2|Reported Event|Treatment as Usual|The Mothers were offered services provided through the family shelter.
321455|NCT01193114|E1|Reported Event|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
321456|NCT01193101|B5|Baseline|Total|Total of all reporting groups
321457|NCT01193101|B4|Baseline|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
321458|NCT01193101|B3|Baseline|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
321459|NCT01193101|B2|Baseline|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321460|NCT01193101|B1|Baseline|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321461|NCT01193101|P4|Participant Flow|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
321462|NCT01193101|P3|Participant Flow|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
321463|NCT01193101|P2|Participant Flow|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321464|NCT01193101|P1|Participant Flow|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321465|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
321466|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
321467|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321468|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321469|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
321470|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321471|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321472|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
321473|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321474|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321475|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
321476|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
321477|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321478|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321479|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
321480|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
321481|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321482|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321483|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
321484|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
321485|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321486|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321487|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
321488|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
321489|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321490|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321491|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
321492|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
321493|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321494|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321495|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
321496|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
321497|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321498|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321499|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
321500|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
321501|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321502|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321503|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
321504|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
321505|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321506|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321507|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
321508|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
321509|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321510|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321511|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
321512|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
321513|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321514|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321515|NCT01193101|E4|Reported Event|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
321516|NCT01193101|E3|Reported Event|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
321517|NCT01193101|E2|Reported Event|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321518|NCT01193101|E1|Reported Event|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
321519|NCT01193049|B1|Baseline|All Participants|All randomized participants
321520|NCT01193049|P2|Participant Flow|Placebo, Then Prednisone|Placebo in the first double blind treatment period and prednisone in the second double blind treatment period
321521|NCT01193049|P1|Participant Flow|Prednisone, Then Placebo|Prednisone in the first double blind treatment period and placebo in the second double blind treatment period
321522|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
321523|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
321524|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
321525|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
321526|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
321527|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
321528|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
321529|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
321530|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
321531|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
321532|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
321533|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
321534|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
321535|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
321536|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
321537|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
321538|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
321539|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
321540|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
321541|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
321544|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
321545|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
321546|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
321547|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
321548|NCT01193049|E2|Reported Event|Placebo|All participants who received at least one dose of placebo
321549|NCT01193049|E1|Reported Event|Prednisone|All participants who received at least one dose of prednisone
321550|NCT01192776|B5|Baseline|Total|Total of all reporting groups
321551|NCT01192776|B4|Baseline|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321552|NCT01192776|B3|Baseline|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321553|NCT01192776|B2|Baseline|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321554|NCT01192776|B1|Baseline|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321555|NCT01192776|P4|Participant Flow|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321556|NCT01192776|P3|Participant Flow|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321557|NCT01192776|P2|Participant Flow|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321558|NCT01192776|P1|Participant Flow|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321559|NCT01192776|O4|Outcome|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321560|NCT01192776|O3|Outcome|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321561|NCT01192776|O2|Outcome|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321562|NCT01192776|O1|Outcome|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321563|NCT01192776|O4|Outcome|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321564|NCT01192776|O3|Outcome|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321565|NCT01192776|O2|Outcome|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321566|NCT01192776|O1|Outcome|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321567|NCT01192776|O4|Outcome|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321568|NCT01192776|O3|Outcome|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321569|NCT01192776|O2|Outcome|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321570|NCT01192776|O1|Outcome|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321571|NCT01192776|O4|Outcome|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321572|NCT01192776|O3|Outcome|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321573|NCT01192776|O2|Outcome|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321642|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
321574|NCT01192776|O1|Outcome|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321575|NCT01192776|O4|Outcome|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321576|NCT01192776|O3|Outcome|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321577|NCT01192776|O2|Outcome|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321578|NCT01192776|O1|Outcome|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321579|NCT01192776|O4|Outcome|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321580|NCT01192776|O3|Outcome|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321581|NCT01192776|O2|Outcome|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321582|NCT01192776|O1|Outcome|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321583|NCT01192776|O4|Outcome|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321584|NCT01192776|O3|Outcome|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321585|NCT01192776|O2|Outcome|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321586|NCT01192776|O1|Outcome|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321587|NCT01192776|O4|Outcome|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321588|NCT01192776|O3|Outcome|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321589|NCT01192776|O2|Outcome|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321590|NCT01192776|O1|Outcome|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321591|NCT01192776|O4|Outcome|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321592|NCT01192776|O3|Outcome|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321593|NCT01192776|O2|Outcome|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321594|NCT01192776|O1|Outcome|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321595|NCT01192776|O4|Outcome|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321596|NCT01192776|O3|Outcome|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321597|NCT01192776|O2|Outcome|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321598|NCT01192776|O1|Outcome|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321599|NCT01192776|O4|Outcome|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321640|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention will be based on a tailored approach using collected data on symptom and activity patterns of each participant.
321600|NCT01192776|O3|Outcome|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321601|NCT01192776|O2|Outcome|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321602|NCT01192776|O1|Outcome|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321603|NCT01192776|E4|Reported Event|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321604|NCT01192776|E3|Reported Event|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321605|NCT01192776|E2|Reported Event|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321606|NCT01192776|E1|Reported Event|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
321607|NCT01192698|B3|Baseline|Total|Total of all reporting groups
321608|NCT01192698|B2|Baseline|no Treatment|standard of care for liver transplant
321609|NCT01192698|B1|Baseline|IV Interferon|"IV interferon oral ribavirin~Aims The purpose of this study was to determine the safety and effect of intravenous interferon (IFN) during the anhepatic phase of LT on hepatitis C viral load. Methods Fifteen consecutive subjects undergoing liver transplant for hepatitis C cirrhosis were enrolled in the study, ten of which received study drug and five subjects served as controls. Cases received weight-based ribavirin and subcutaneous IFN at time of incision followed by intravenous IFN at the start of the anhepatic phase."
321610|NCT01192698|P2|Participant Flow|no Treatment|standard of care
321611|NCT01192698|P1|Participant Flow|IV Interferon|"IV interferon oral ribavirin~IV interferon: IV interferon 5MU during anhepatic phase"
321612|NCT01192698|O2|Outcome|no Treatment|standard of care for liver transplant
321613|NCT01192698|O1|Outcome|IV Interferon|"IV interferon oral ribavirin~Aims The purpose of this study was to determine the safety and effect of intravenous interferon (IFN) during the anhepatic phase of LT on hepatitis C viral load. Methods Fifteen consecutive subjects undergoing liver transplant for hepatitis C cirrhosis were enrolled in the study, ten of which received study drug and five subjects served as controls. Cases received weight-based ribavirin and subcutaneous IFN at time of incision followed by intravenous IFN at the start of the anhepatic phase."
321614|NCT01192698|E2|Reported Event|no Treatment|standard of care for liver transplant
321615|NCT01192698|E1|Reported Event|IV Interferon|"IV interferon oral ribavirin~IV interferon: IV interferon 5MU during anhepatic phase"
321616|NCT01192542|B1|Baseline|All Subjects|All subjects who enrolled in the study.
321617|NCT01192542|P2|Participant Flow|Enfilcon A Lens/Galyfilcon A Prototype Lens|The enfilcon A contact lens worn daily for 6-8 days first then the galyfilcon A prototype contact lens worn daily for 6-8 days second.
321618|NCT01192542|P1|Participant Flow|Galyfilcon A Prototype Lens/Enfilcon A Lens|The galyfilcon A prototype contact lens worn daily for 6-8 days first then the enfilcon A contact lens worn daily for 6-8 days second.
321619|NCT01192542|O2|Outcome|Enfilcon A Lens|Marketed silicone hydrogel lens.
321620|NCT01192542|O1|Outcome|Galyfilcon A Prototype Lens|Prototype silicone hydrogel lens.
321621|NCT01192542|O2|Outcome|Enfilcon A Lens|Marketed silicone hydrogel contact lens.
321622|NCT01192542|O1|Outcome|Galyfilcon A Prototype Lens|Prototype silicone hydrogel contact lens.
321623|NCT01192542|O2|Outcome|Enfilcon A Lens|Marketed silicone hydrogel lens.
321624|NCT01192542|O1|Outcome|Galyfilcon A Prototype Lens|Prototype silicon hydrogel contact lens.
321625|NCT01192542|O2|Outcome|Enfilcon A Lens|Marketed silicone hydrogel lens.
321626|NCT01192542|O1|Outcome|Galyfilcon A Prototype Lens|Prototype silicone hydrogel lens.
321627|NCT01192542|E1|Reported Event|All Subjects|All subjects who exposed to the Investigation lenses.
321628|NCT01192516|B4|Baseline|Total|Total of all reporting groups
321629|NCT01192516|B3|Baseline|Arm 3|Usual care group
321630|NCT01192516|B2|Baseline|Arm 2|"General activity pacing and symptom management~General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms"
321631|NCT01192516|B1|Baseline|Arm 1|"Tailored activity pacing~Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant."
321632|NCT01192516|P3|Participant Flow|Usual Care Group|Participants receiving usual care
321633|NCT01192516|P2|Participant Flow|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
321634|NCT01192516|P1|Participant Flow|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
321635|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
321636|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
321637|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
321638|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
321639|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
321641|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
321643|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
321644|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
321645|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
321646|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
321647|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
321648|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
321649|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
321650|NCT01192516|O3|Outcome|Arm 3|Usual care group
321651|NCT01192516|O2|Outcome|Arm 2|"General activity pacing and symptom management~General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms"
321652|NCT01192516|O1|Outcome|Arm 1|"Tailored activity pacing~Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant."
321653|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
321654|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
321655|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
321656|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
321657|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
321658|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
321659|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
321660|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
321661|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
321662|NCT01192516|E3|Reported Event|Arm 3|Usual care group
321663|NCT01192516|E2|Reported Event|Arm 2|"General activity pacing and symptom management~General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms"
321664|NCT01192516|E1|Reported Event|Arm 1|"Tailored activity pacing~Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant."
321665|NCT01192412|B3|Baseline|Total|Total of all reporting groups
321666|NCT01192412|B2|Baseline|'Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 85 mmHg.~Intervention is blood pressure management approach.: 'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is <80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is >85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery."
321667|NCT01192412|B1|Baseline|'Less Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 100 mmHg.~Intervention is blood pressure management approach: 1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is >105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP <100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery."
321668|NCT01192412|P2|Participant Flow|'Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 85 mmHg.~Intervention is blood pressure management approach.: 'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is <80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is >85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery."
321669|NCT01192412|P1|Participant Flow|'Less Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 100 mmHg.~Intervention is blood pressure management approach: 1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is >105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP <100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery."
321670|NCT01192412|O2|Outcome|'Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 85 mmHg.~Intervention is blood pressure management approach.: 'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is <80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is >85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery."
321671|NCT01192412|O1|Outcome|'Less Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 100 mmHg.~Intervention is blood pressure management approach: 1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is >105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP <100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery."
321672|NCT01192412|O2|Outcome|'Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 85 mmHg.~Intervention is blood pressure management approach.: 'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is <80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is >85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery."
321711|NCT01192295|P1|Participant Flow|6 to < 12 Years|Children 6 to < 12 years of age
321712|NCT01192295|O1|Outcome|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
321713|NCT01192295|O1|Outcome|6 to < 12 Years|Children 6 to < 12 years of age
321673|NCT01192412|O1|Outcome|'Less Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 100 mmHg.~Intervention is blood pressure management approach: 1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is >105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP <100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery."
321674|NCT01192412|E2|Reported Event|'Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 85 mmHg.~Intervention is blood pressure management approach.: 'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is <80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is >85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery."
321675|NCT01192412|E1|Reported Event|'Less Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 100 mmHg.~Intervention is blood pressure management approach: 1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is >105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP <100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery."
321676|NCT01192399|B1|Baseline|Eculizumab|Eculizumab intravenous infusions every week x 4 doses, then 900 mg 1 week later for 1 dose, then 900 mg every 2 weeks for 4 doses
321677|NCT01192399|P1|Participant Flow|Eculizumab|Eculizumab intravenous infusions every week x 4 doses, then 900 mg 1 week later for 1 dose, then 900 mg every 2 weeks for 4 doses
321678|NCT01192399|O1|Outcome|Eculizumab|Eculizumab intravenous infusions every week x 4 doses, then 900 mg 1 week later for 1 dose, then 900 mg every 2 weeks for 4 doses
321679|NCT01192399|O1|Outcome|Eculizumab|Eculizumab intravenous infusions every week x 4 doses, then 900 mg 1 week later for 1 dose, then 900 mg every 2 weeks for 4 doses
321680|NCT01192399|O1|Outcome|Eculizumab|Eculizumab intravenous infusions every week x 4 doses, then 900 mg 1 week later for 1 dose, then 900 mg every 2 weeks for 4 doses
321681|NCT01192399|O1|Outcome|Eculizumab|Eculizumab intravenous infusions every week x 4 doses, then 900 mg 1 week later for 1 dose, then 900 mg every 2 weeks for 4 doses
321682|NCT01192399|O1|Outcome|Eculizumab|Eculizumab intravenous infusions every week x 4 doses, then 900 mg 1 week later for 1 dose, then 900 mg every 2 weeks for 4 doses
321683|NCT01192399|O1|Outcome|Eculizumab|Eculizumab intravenous infusions every week x 4 doses, then 900 mg 1 week later for 1 dose, then 900 mg every 2 weeks for 4 doses
321684|NCT01192399|O1|Outcome|Eculizumab|Eculizumab intravenous infusions every week x 4 doses, then 900 mg 1 week later for 1 dose, then 900 mg every 2 weeks for 4 doses
321685|NCT01192399|E1|Reported Event|Eculizumab|600 mg of eculizumab as intravenous (IV) infusion once a week for 4 doses, followed by 900 mg eculizumab IV infusion 1 week later for 1 dose, then 900 mg eculizumab IV infusion every 2 weeks for 4 doses.
321686|NCT01192347|B1|Baseline|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
321687|NCT01192347|P1|Participant Flow|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
321688|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
321689|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
321690|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
321691|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
321692|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
321693|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
321694|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
321695|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
321696|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
321697|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
321698|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
321699|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
321700|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
321701|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
321702|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
321703|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
321704|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
321705|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
321706|NCT01192347|E1|Reported Event|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
321707|NCT01192295|B3|Baseline|Total|Total of all reporting groups
321708|NCT01192295|B2|Baseline|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
321709|NCT01192295|B1|Baseline|6 to < 12 Years|Children 6 to < 12 years of age
321710|NCT01192295|P2|Participant Flow|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
321714|NCT01192295|O2|Outcome|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
321715|NCT01192295|O1|Outcome|6 to < 12 Years|Children 6 to < 12 years of age
321716|NCT01192295|O2|Outcome|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
321717|NCT01192295|O1|Outcome|6 to < 12 Years|Children 6 to < 12 years of age
321718|NCT01192295|O1|Outcome|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
321719|NCT01192295|O1|Outcome|6 to < 12 Years|Children 6 to < 12 years of age
321720|NCT01192295|O2|Outcome|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
321721|NCT01192295|O1|Outcome|6 to < 12 Years|Children 6 to < 12 years of age
321722|NCT01192295|E2|Reported Event|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
321723|NCT01192295|E1|Reported Event|6 to < 12 Years|Children 6 to < 12 years of age
321724|NCT01192282|B4|Baseline|Total|Total of all reporting groups
321725|NCT01192282|B3|Baseline|Persistent Cases|The warts presence after completion of treatment
321726|NCT01192282|B2|Baseline|Recurrent Cases|Reappearance of genital warts at 3 or 6 months post-treatment in participants free of warts at completion of treatment
321727|NCT01192282|B1|Baseline|New Cases|Newly diagnosed cases of genital warts
321728|NCT01192282|P1|Participant Flow|Number of Participants|Participants with Genital Warts
321729|NCT01192282|O2|Outcome|HIV Negative|Number of participants with HIV Negative
321730|NCT01192282|O1|Outcome|HIV Positive|Number of participants with HIV Positive
321731|NCT01192282|O3|Outcome|HIV Unknown|Participants who Refused HIV Testing
321732|NCT01192282|O2|Outcome|HIV Negative|Participants with HIV Negative
321733|NCT01192282|O1|Outcome|HIV Positive|Participants with HIV Positive
321734|NCT01192282|O2|Outcome|HPV DNA Negative|Participants with HPV DNA Negative
321735|NCT01192282|O1|Outcome|HPV DNA Positive|Participants with HPV DNA Positive
321736|NCT01192282|O3|Outcome|HIV Unknown|Number of participants who refused HIV Testing
321737|NCT01192282|O2|Outcome|HIV Negative|Number of participants with HIV Negative
321738|NCT01192282|O1|Outcome|HIV Positive|Number of participants with HIV Positive
321739|NCT01192282|E3|Reported Event|HIV Unknown|Participants with Genital Warts whom HIV Status was Unknown
321740|NCT01192282|E2|Reported Event|HIV Negative|Participants with Genital Warts who were HIV Negative
321741|NCT01192282|E1|Reported Event|HIV Positive|Participants with Genital Warts who were HIV Positive
321742|NCT01192204|B3|Baseline|Total|Total of all reporting groups
321743|NCT01192204|B2|Baseline|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel~Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
321744|NCT01192204|B1|Baseline|10% FBR Gel|"Active 10% FBR containing bioadhesive gel~Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
321745|NCT01192204|P2|Participant Flow|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel~Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
321746|NCT01192204|P1|Participant Flow|10% FBR Gel|"Active 10% FBR containing bioadhesive gel~Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
321747|NCT01192204|O2|Outcome|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel~Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
321748|NCT01192204|O1|Outcome|10% FBR Gel|"Active 10% FBR containing bioadhesive gel~Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
321749|NCT01192204|O2|Outcome|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel~Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
321750|NCT01192204|O1|Outcome|10% FBR Gel|"Active 10% FBR containing bioadhesive gel~Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months."
321751|NCT01192204|O2|Outcome|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel~Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
321752|NCT01192204|O1|Outcome|10% FBR Gel|"Active 10% FBR containing bioadhesive gel~Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
321753|NCT01192204|E2|Reported Event|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel~Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months~No adverse events"
321754|NCT01192204|E1|Reported Event|10% FBR Gel|"Active 10% FBR containing bioadhesive gel~Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months~No adverse events"
321755|NCT01192191|B3|Baseline|Total|Total of all reporting groups
321756|NCT01192191|B2|Baseline|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
321757|NCT01192191|B1|Baseline|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
321758|NCT01192191|P2|Participant Flow|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
321759|NCT01192191|P1|Participant Flow|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
321760|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
321801|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|Fluticasone Propionate (FP) DISKUS 100 mcg administered as one inhalation BID for 16 weeks
321761|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
321762|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
321763|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
321764|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
321765|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
321766|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
321767|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
321768|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
321769|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
321770|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
321771|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
321772|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
321773|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
321774|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
321775|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
321776|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
321777|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
321778|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
321779|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
321780|NCT01192191|E2|Reported Event|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
321781|NCT01192191|E1|Reported Event|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
321782|NCT01192178|B3|Baseline|Total|Total of all reporting groups
321783|NCT01192178|B2|Baseline|FP DISKUS 100 mcg BID|Fluticasone Propionate (FP) DISKUS 100 mcg administered as one inhalation BID for 16 weeks
321784|NCT01192178|B1|Baseline|FSC DISKUS 100/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) at a dose of 100/50 micrograms (mcg) administered as one inhalation twice daily (BID) for 16 weeks
321785|NCT01192178|P2|Participant Flow|FP DISKUS 100 mcg BID|Fluticasone Propionate (FP) DISKUS 100 mcg administered as one inhalation BID for 16 weeks
321786|NCT01192178|P1|Participant Flow|FSC DISKUS 100/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) at a dose of 100/50 micrograms (mcg) administered as one inhalation twice daily (BID) for 16 weeks
321787|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
321788|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
321789|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
321790|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
321791|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
321792|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
321793|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
321794|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
321795|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
321796|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
321797|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
321798|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
321799|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
321800|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
321802|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) at a dose of 100/50 micrograms (mcg) administered as one inhalation twice daily (BID) for 16 weeks
321803|NCT01192178|E2|Reported Event|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
321804|NCT01192178|E1|Reported Event|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
321805|NCT01192152|B1|Baseline|All Enrolled and Treated Participants|
321806|NCT01192152|P2|Participant Flow|Treatment Sequence BA|Treatment B (period 1):Fixed dose combination (FDC) tablet (5 mg saxa + 1000 mg metformin XR), single dose, under fed conditions; Treatment A (period 2): 5 mg saxagliptin + 2 Glucophage XR 500 mg under fed conditions. Participants underwent a 2-day washout period between Periods 1 and 2.
321807|NCT01192152|P1|Participant Flow|Treatment Sequence ABC|Treatment A (period 1): 5 mg saxagliptin + 2 Glucophage XR 500 mg under fed conditions; Treatment B (period 2):Fixed dose combination (FDC) tablet (5 mg saxa + 1000 mg metformin XR), single dose, under fed conditions; Treatment C (period 3): FDC tablet (5 mg saxa + 1000 mg metformin XR), once daily for 4 days, under fed conditions. Participants underwent a 2-day washout period between Periods 1 and 2. There was no washout between Periods 2 and 3.
321808|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321809|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321810|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321811|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321812|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321813|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321814|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321815|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321816|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321817|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321818|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321819|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321820|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321821|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321822|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321823|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321824|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321825|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321826|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321827|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321828|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321829|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321830|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321831|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321832|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321833|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321834|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321835|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321836|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321837|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321838|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321839|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321840|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321841|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321842|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321843|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321844|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321845|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321846|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321847|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321848|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321849|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321850|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321851|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321852|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321853|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321854|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321855|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321856|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321857|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321858|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321859|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321860|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321861|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321862|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321863|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321864|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321865|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321866|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321867|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321868|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321869|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321870|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321871|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321872|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321873|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321874|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321875|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321876|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321877|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321878|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321879|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321880|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321881|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321882|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321883|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321884|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321885|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321886|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321887|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321888|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321889|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321890|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321891|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321892|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321893|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321894|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321895|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321896|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321897|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321898|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321899|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321900|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321901|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321902|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321903|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321904|NCT01192152|E3|Reported Event|Saxa 5mg/500mg Metformin, Fed 4 Days|FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
321905|NCT01192152|E2|Reported Event|Saxa 5mg/1000mg Metformin, Fed|Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
321906|NCT01192152|E1|Reported Event|Saxa 5mg + 2x500mg Metformin, Fed|5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
321907|NCT01192139|B1|Baseline|All Enrolled and Treated Participants|
321908|NCT01192139|P6|Participant Flow|Treatment Sequence CBA|Treatment C (period 1): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions; Treatment B (period 2): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions; Treatment A (period 3): 5 mg saxagliptin + a single 500 mg metformin XR tablet. Participants underwent at least a 3-day washout period between each treatment.
321909|NCT01192139|P5|Participant Flow|Treatment Sequence CAB|Treatment C (period 1): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions; Treatment A (period 2): 5 mg saxagliptin + a single 500 mg metformin XR tablet; Treatment B (period 3): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions. Participants underwent at least a 3-day washout period between each treatment.
321910|NCT01192139|P4|Participant Flow|Treatment Sequence BCA|Treatment B (period 1): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions; Treatment C (period 2): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions; Treatment A (period 3): 5 mg saxagliptin + a single 500 mg metformin XR tablet. Participants underwent at least a 3-day washout period between each treatment.
321911|NCT01192139|P3|Participant Flow|Treatment Sequence BAC|Treatment B (period 1): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions; Treatment A (period 2): 5 mg saxagliptin + a single 500 mg metformin XR tablet; Treatment C (period 3): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions. Participants underwent at least a 3-day washout period between each treatment.
321912|NCT01192139|P2|Participant Flow|Treatment Sequence ACB|Treatment A (period 1): 5 mg saxagliptin + a single 500 mg metformin XR tablet; Treatment C (period 2): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions; Treatment B (period 3): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions. Participants underwent at least a 3-day washout period between each treatment.
321913|NCT01192139|P1|Participant Flow|Treatment Sequence ABC|Treatment A (period 1): 5 mg saxagliptin + a single 500 mg metformin XR tablet; Treatment B (period 2): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions; Treatment C (period 3): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions. Participants underwent at least a 3-day washout period between each treatment.
321914|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
321915|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
321916|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
321917|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
321918|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
321919|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
321920|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
321921|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
321922|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
322120|NCT01191762|B3|Baseline|Total|Total of all reporting groups
321923|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
321924|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
321925|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
321926|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
321927|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
321928|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
321929|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
321930|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
321931|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
321932|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
321933|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
321934|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
321935|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
321936|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
321937|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
321938|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
321939|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
321940|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
321941|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
321942|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
321943|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
321944|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
321945|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
321946|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
321947|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
321948|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
321949|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
321950|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
321951|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
321952|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
321953|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
321954|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
321955|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
321956|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
321957|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
321958|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
321959|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
321960|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
321961|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
321962|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
321963|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
321964|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
321965|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
321966|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
321967|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
321968|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
321969|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
321970|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
321971|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
321972|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
321973|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
321974|NCT01192139|E3|Reported Event|Treatment B|Fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
321975|NCT01192139|E2|Reported Event|Treatment C|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
321976|NCT01192139|E1|Reported Event|Treatment A|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
321977|NCT01192126|B1|Baseline|Overall Study|All eligible subjects
321978|NCT01192126|P2|Participant Flow|J & J Acuvue Moist, Then B & L Daily Disposable Lens|Johnson & Johnson Acuvue Moist lenses are to be worn for approximately one week. Crossover to Bausch & Lomb new daily disposable lenses to be worn for approximately one week. Lenses will be worn on a daily wear basis.
321979|NCT01192126|P1|Participant Flow|B & L Daily Disposable Lens, Then J & J Acuvue Moist|Bausch & Lomb new daily disposable lenses are to be worn for approximately one week. Crossover to Johnson & Johnson Acuvue Moist lenses to be worn for approximately one week. Lenses will be worn on a daily wear basis.
321980|NCT01192126|O2|Outcome|Johnson & Johnson Acuvue Moist|"Contact lenses~Johnson & Johnson Acuvue Moist : Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
321981|NCT01192126|O1|Outcome|Bausch & Lomb New Daily Disposable|"New daily disposable contact lenses~Bausch & Lomb new daily disposable : Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
321982|NCT01192126|O2|Outcome|Johnson & Johnson Acuvue Moist|"Contact lenses~Johnson & Johnson Acuvue Moist : Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
321983|NCT01192126|O1|Outcome|Bausch & Lomb New Daily Disposable|"New daily disposable contact lenses~Bausch & Lomb new daily disposable : Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
321984|NCT01192126|E2|Reported Event|Johnson & Johnson Acuvue Moist|"Contact lenses~Johnson & Johnson Acuvue Moist : Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
321985|NCT01192126|E1|Reported Event|Bausch & Lomb New Daily Disposable|"New daily disposable contact lenses~Bausch & Lomb new daily disposable : Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
321986|NCT01192022|B5|Baseline|Total|Total of all reporting groups
321987|NCT01192022|B4|Baseline|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
321988|NCT01192022|B3|Baseline|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
321989|NCT01192022|B2|Baseline|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
321990|NCT01192022|B1|Baseline|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
321991|NCT01192022|P5|Participant Flow|TachoSil® Extension Analysis Set (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
321992|NCT01192022|P4|Participant Flow|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
321993|NCT01192022|P3|Participant Flow|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
321994|NCT01192022|P2|Participant Flow|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
321995|NCT01192022|P1|Participant Flow|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
321996|NCT01192022|O5|Outcome|TachoSil® Extension Analysis Set (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
321997|NCT01192022|O4|Outcome|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
321998|NCT01192022|O3|Outcome|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
321999|NCT01192022|O2|Outcome|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
322000|NCT01192022|O1|Outcome|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
322001|NCT01192022|O5|Outcome|TachoSil® Extension Analysis Set (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
322002|NCT01192022|O4|Outcome|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
322003|NCT01192022|O3|Outcome|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
322004|NCT01192022|O2|Outcome|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
322005|NCT01192022|O1|Outcome|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
322006|NCT01192022|O5|Outcome|TachoSil® Extension Analysis Set (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
322007|NCT01192022|O4|Outcome|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
322008|NCT01192022|O3|Outcome|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
322009|NCT01192022|O2|Outcome|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
322010|NCT01192022|O1|Outcome|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
322011|NCT01192022|E4|Reported Event|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
322012|NCT01192022|E3|Reported Event|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
322013|NCT01192022|E2|Reported Event|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
322014|NCT01192022|E1|Reported Event|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
322015|NCT01191944|B3|Baseline|Total|Total of all reporting groups
322016|NCT01191944|B2|Baseline|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
322017|NCT01191944|B1|Baseline|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
322018|NCT01191944|P2|Participant Flow|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
322019|NCT01191944|P1|Participant Flow|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
322121|NCT01191762|B2|Baseline|Placebo Control|"3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.~placebo : 3 tablets with each meal"
322020|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
322021|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
322022|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
322023|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
322024|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
322025|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
322026|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
322027|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
322028|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
322029|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
322030|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
322031|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
322032|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
322033|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
322034|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
322035|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
322036|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
322037|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
322038|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
322039|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
322040|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
322041|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
322042|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
322043|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
322044|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
322045|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
322046|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
322047|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
322048|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
322049|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
322050|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
322051|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
322052|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
322053|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
322054|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
322055|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
322056|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
322057|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
322058|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
322059|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
322060|NCT01191944|E2|Reported Event|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
322061|NCT01191944|E1|Reported Event|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
322062|NCT01191840|B3|Baseline|Total|Total of all reporting groups
322063|NCT01191840|B2|Baseline|Algorithm-determined Therapy|Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 – 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
322064|NCT01191840|B1|Baseline|Standard of Care|Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient’s primary medical provider.
322065|NCT01191840|P2|Participant Flow|Algorithm-determined Therapy|Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 – 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
322066|NCT01191840|P1|Participant Flow|Standard of Care|Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient’s primary medical provider.
322067|NCT01191840|O2|Outcome|Algorithm-determined Therapy|Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 – 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
322068|NCT01191840|O1|Outcome|Standard of Care|Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient’s primary medical provider.
322069|NCT01191840|O2|Outcome|Algorithm-determined Therapy|Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 – 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
322070|NCT01191840|O1|Outcome|Standard of Care|Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient’s primary medical provider.
322071|NCT01191840|O2|Outcome|Algorithm-determined Therapy|Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 – 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
322072|NCT01191840|O1|Outcome|Standard of Care|Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient’s primary medical provider.
322073|NCT01191840|O2|Outcome|Algorithm-determined Therapy|Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 – 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
322074|NCT01191840|O1|Outcome|Standard of Care|Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient’s primary medical provider.
322122|NCT01191762|B1|Baseline|Sevelamer Carbonate|"2400 mg (3 pills) with each meal~sevelamer carbonate : 2400 mg with each meal for 4 weeks"
322123|NCT01191762|P2|Participant Flow|Placebo Control|"3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.~placebo : 3 tablets with each meal"
322075|NCT01191840|O2|Outcome|Algorithm-determined Therapy|Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 – 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
322076|NCT01191840|O1|Outcome|Standard of Care|Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient’s primary medical provider.
322077|NCT01191840|E2|Reported Event|Algorithm-determined Therapy|Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 – 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
322078|NCT01191840|E1|Reported Event|Standard of Care|Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient’s primary medical provider.
322079|NCT01191827|B3|Baseline|Total|Total of all reporting groups
322080|NCT01191827|B2|Baseline|Clozapine|Patients with schizophrenia treated with clozapine
322081|NCT01191827|B1|Baseline|Risperidone|Patients with schizophrenia treated with risperidone
322082|NCT01191827|P2|Participant Flow|Clozapine|Patients with schizophrenia treated with clozapine
322083|NCT01191827|P1|Participant Flow|Risperidone|Patients with schizophrenia treated with risperidone
322084|NCT01191827|O2|Outcome|Clozapine|Patients with schizophrenia treated with clozapine
322085|NCT01191827|O1|Outcome|Risperidone|Patients with schizophrenia treated with risperidone
322086|NCT01191827|E2|Reported Event|Clozapine|Patients with schizophrenia treated with clozapine
322087|NCT01191827|E1|Reported Event|Risperidone|Patients with schizophrenia treated with risperidone
322088|NCT01191801|B3|Baseline|Total|Total of all reporting groups
322089|NCT01191801|B2|Baseline|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
322090|NCT01191801|B1|Baseline|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
322091|NCT01191801|P2|Participant Flow|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
322092|NCT01191801|P1|Participant Flow|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
322093|NCT01191801|O2|Outcome|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
322094|NCT01191801|O1|Outcome|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
322095|NCT01191801|O2|Outcome|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
322096|NCT01191801|O1|Outcome|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
322097|NCT01191801|O2|Outcome|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
322098|NCT01191801|O1|Outcome|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
322099|NCT01191801|O2|Outcome|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
322100|NCT01191801|O1|Outcome|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
322101|NCT01191801|O2|Outcome|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
322102|NCT01191801|O1|Outcome|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
322103|NCT01191801|O2|Outcome|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
322104|NCT01191801|O1|Outcome|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
322105|NCT01191801|O2|Outcome|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
322106|NCT01191801|O1|Outcome|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
322107|NCT01191801|E2|Reported Event|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
322108|NCT01191801|E1|Reported Event|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
322109|NCT01191788|B3|Baseline|Total|Total of all reporting groups
322110|NCT01191788|B2|Baseline|Comparison|Treatment as Usual comparison condition
322111|NCT01191788|B1|Baseline|Group CBT|Clients received up to 16 sessions of group CBT for depression
322112|NCT01191788|P2|Participant Flow|Comparison|Treatment as Usual comparison condition
322113|NCT01191788|P1|Participant Flow|Group CBT|Clients received up to 16 sessions of group CBT for depression
322114|NCT01191788|O2|Outcome|Comparison|Usual care.
322115|NCT01191788|O1|Outcome|Group CBT|Usual care + BRIGHT intervention. The BRIGHT intervention included 16 two-hour group sessions of CBT for depression.
322116|NCT01191788|O2|Outcome|Comparison|Usual care
322117|NCT01191788|O1|Outcome|Group CBT|Usual care + BRIGHT intervention. The BRIGHT intervention included 16 two-hour group sessions of CBT for depression.
322118|NCT01191788|E2|Reported Event|Comparison|Treatment as Usual comparison condition
322119|NCT01191788|E1|Reported Event|Group CBT|Clients received up to 16 sessions of group CBT for depression
322124|NCT01191762|P1|Participant Flow|Sevelamer Carbonate|"2400 mg (3 pills) with each meal~sevelamer carbonate : 2400 mg with each meal for 4 weeks"
322125|NCT01191762|O2|Outcome|Placebo Control|"3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.~placebo : 3 tablets with each meal"
322126|NCT01191762|O1|Outcome|Sevelamer Carbonate|"2400 mg (3 pills) with each meal~sevelamer carbonate : 2400 mg with each meal for 4 weeks"
322127|NCT01191762|E2|Reported Event|Placebo Control|"3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.~placebo : 3 tablets with each meal"
322128|NCT01191762|E1|Reported Event|Sevelamer Carbonate|"2400 mg (3 pills) with each meal~sevelamer carbonate : 2400 mg with each meal for 4 weeks"
322129|NCT01191749|B1|Baseline|Alemtuzumab|Alemtuzumab 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
322130|NCT01191749|P1|Participant Flow|Alemtuzumab|Alemtuzumab 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
322131|NCT01191749|O1|Outcome|Alemtuzumab|Alemtuzumab 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
322132|NCT01191749|E1|Reported Event|Alemtuzumab|Alemtuzumab 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
322133|NCT01191736|B8|Baseline|Total|Total of all reporting groups
322134|NCT01191736|B7|Baseline|Brief Video + hands-on; Ass'd 2 Months Later|Subjects receive a brief (5-minute) video with hands-on manikin practice, and were assessed 2 months later
322135|NCT01191736|B6|Baseline|Brief Video; Assessed 2 Months Later|Subjects receive a brief (5-minute) video on hands-only CPR, and were assessed two months later
322136|NCT01191736|B5|Baseline|Ultra-brief Video; Assessed at 2 Months|Subjects receive an ultra-brief (90-second) video on hands-only CPR, and were assessed 2 months later
322137|NCT01191736|B4|Baseline|Brief Video + hands-on; Ass'd in 60 Mins|Subjects receive a brief (5-minute) video with hands-on manikin practice
322138|NCT01191736|B3|Baseline|Brief Video; Assessed in 60 Mins|Subjects receive a brief (5-minute) video on hands-only CPR
322139|NCT01191736|B2|Baseline|Ultra-brief Video; Assessed in 60 Mins|Subjects receive an ultra-brief (90-second) video on hands-only CPR
322140|NCT01191736|B1|Baseline|No Training, Assessed Within 60 Mins|The subjects received no training and were assessed within 60 minutes
322141|NCT01191736|P7|Participant Flow|Brief Video + hands-on; Ass'd 2 Months Later|Subjects receive a brief (5-minute) video with hands-on manikin practice, and were assessed 2 months later
322142|NCT01191736|P6|Participant Flow|Brief Video; Assessed 2 Months Later|Subjects receive a brief (5-minute) video on hands-only CPR, and were assessed two months later
322143|NCT01191736|P5|Participant Flow|Ultra-brief Video; Assessed at 2 Months|Subjects receive an ultra-brief (90-second) video on hands-only CPR, and were assessed 2 months later
322144|NCT01191736|P4|Participant Flow|Brief Video + hands-on; Ass'd in 60 Mins|Subjects receive a brief (5-minute) video with hands-on manikin practice
322145|NCT01191736|P3|Participant Flow|Brief Video; Assessed in 60 Mins|Subjects receive a brief (5-minute) video on hands-only CPR
322146|NCT01191736|P2|Participant Flow|Ultra-brief Video; Assessed in 60 Mins|Subjects receive an ultra-brief (90-second) video on hands-only CPR
322147|NCT01191736|P1|Participant Flow|No Training, Assessed Within 60 Mins|The subjects received no training and were assessed within 60 minutes
322148|NCT01191736|O7|Outcome|Brief Video + hands-on; Ass'd 2 Months Later|Subjects receive a brief (5-minute) video with hands-on manikin practice, and were assessed 2 months later
322149|NCT01191736|O6|Outcome|Brief Video; Assessed 2 Months Later|Subjects receive a brief (5-minute) video on hands-only CPR, and were assessed two months later
322150|NCT01191736|O5|Outcome|Ultra-brief Video; Assessed at 2 Months|Subjects receive an ultra-brief (90-second) video on hands-only CPR, and were assessed 2 months later
322151|NCT01191736|O4|Outcome|Brief Video + hands-on; Ass'd in 60 Mins|Subjects receive a brief (5-minute) video with hands-on manikin practice
322152|NCT01191736|O3|Outcome|Brief Video; Assessed in 60 Mins|Subjects receive a brief (5-minute) video on hands-only CPR
322153|NCT01191736|O2|Outcome|Ultra-brief Video; Assessed in 60 Mins|Subjects receive an ultra-brief (90-second) video on hands-only CPR
322154|NCT01191736|O1|Outcome|No Training, Assessed Within 60 Mins|The subjects received no training and were assessed within 60 minutes
322155|NCT01191736|O7|Outcome|Brief Video + hands-on; Ass'd 2 Months Later|Subjects receive a brief (5-minute) video with hands-on manikin practice, and were assessed 2 months later
322156|NCT01191736|O6|Outcome|Brief Video; Assessed 2 Months Later|Subjects receive a brief (5-minute) video on hands-only CPR, and were assessed two months later
322157|NCT01191736|O5|Outcome|Ultra-brief Video; Assessed at 2 Months|Subjects receive an ultra-brief (90-second) video on hands-only CPR, and were assessed 2 months later
322158|NCT01191736|O4|Outcome|Brief Video + hands-on; Ass'd in 60 Mins|Subjects receive a brief (5-minute) video with hands-on manikin practice
322159|NCT01191736|O3|Outcome|Brief Video; Assessed in 60 Mins|Subjects receive a brief (5-minute) video on hands-only CPR
322160|NCT01191736|O2|Outcome|Ultra-brief Video; Assessed in 60 Mins|Subjects receive an ultra-brief (90-second) video on hands-only CPR
322161|NCT01191736|O1|Outcome|No Training, Assessed Within 60 Mins|The subjects received no training and were assessed within 60 minutes
322162|NCT01191736|E7|Reported Event|Brief Video + hands-on; Ass'd 2 Months Later|Subjects receive a brief (5-minute) video with hands-on manikin practice, and were assessed 2 months later
322163|NCT01191736|E6|Reported Event|Brief Video; Assessed 2 Months Later|Subjects receive a brief (5-minute) video on hands-only CPR, and were assessed two months later
322164|NCT01191736|E5|Reported Event|Ultra-brief Video; Assessed at 2 Months|Subjects receive an ultra-brief (90-second) video on hands-only CPR, and were assessed 2 months later
322165|NCT01191736|E4|Reported Event|Brief Video + hands-on; Ass'd in 60 Mins|Subjects receive a brief (5-minute) video with hands-on manikin practice
322166|NCT01191736|E3|Reported Event|Brief Video; Assessed in 60 Mins|Subjects receive a brief (5-minute) video on hands-only CPR
322167|NCT01191736|E2|Reported Event|Ultra-brief Video; Assessed in 60 Mins|Subjects receive an ultra-brief (90-second) video on hands-only CPR
322168|NCT01191736|E1|Reported Event|No Training, Assessed Within 60 Mins|The subjects received no training and were assessed within 60 minutes
322169|NCT01191723|B1|Baseline|All Subjects|All subjects enrolled in the study.
322170|NCT01191723|P6|Participant Flow|Treatment C, Then B, Then A|Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4.
322171|NCT01191723|P5|Participant Flow|Treatment C, Then A, Then B|"Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3.~Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4."
322172|NCT01191723|P4|Participant Flow|Treatment B, Then C, Then A|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4.
322173|NCT01191723|P3|Participant Flow|Treatment B, Then A, Then C|"Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3.~Treatment C = inhaler placebo and placebo capsules at Visit 4."
322174|NCT01191723|P2|Participant Flow|Treatment A, Then C, Then B|"Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2.~Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4."
322175|NCT01191723|P1|Participant Flow|Treatment A, Then B, Then C|"Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2.~Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment C = inhaler placebo and placebo capsules at Visit 4."
322176|NCT01191723|O3|Outcome|Treatment A (Moxifloxacin)|Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet.
322177|NCT01191723|O2|Outcome|Treatment B (MAP0004 3.0mg)|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
322178|NCT01191723|O1|Outcome|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules at Visit 3.
322179|NCT01191723|O3|Outcome|Treatment A (Moxifloxacin)|Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet.
322180|NCT01191723|O2|Outcome|Treatment B (MAP0004 3.0mg)|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
322181|NCT01191723|O1|Outcome|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules at Visit 3.
322182|NCT01191723|O2|Outcome|Treatment B (MAP0004 3.0mg)|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
322183|NCT01191723|O1|Outcome|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules.
322184|NCT01191723|O3|Outcome|Treatment A (Moxifloxacin)|Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet.
322185|NCT01191723|O2|Outcome|Treatment B (MAP0004 3.0mg)|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
322186|NCT01191723|O1|Outcome|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules at Visit 3.
322187|NCT01191723|O2|Outcome|Treatment B (MAP0004 3.0mg)|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
322188|NCT01191723|O1|Outcome|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules.
322189|NCT01191723|E3|Reported Event|Treatment A (Moxifloxacin)|Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet
322190|NCT01191723|E2|Reported Event|Treatment B (MAP0004 3.0mg)|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules
322191|NCT01191723|E1|Reported Event|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules
322192|NCT01191476|B4|Baseline|Total|Total of all reporting groups
322193|NCT01191476|B3|Baseline|Propofol Induction Sevoflurane Maintenance|Propofol induction and sevoflurane maintenance anesthesia.
322194|NCT01191476|B2|Baseline|Propofol|Target controlled infusion anesthesia with propofol for induction and maintenance.
322195|NCT01191476|B1|Baseline|Sevoflurane|Inhalational induction and maintenance anesthesia with sevoflurane.
322196|NCT01191476|P3|Participant Flow|Propofol Induction Sevoflurane Maintenance|Propofol induction and sevoflurane maintenance anesthesia.
322197|NCT01191476|P2|Participant Flow|Propofol|Target controlled infusion anesthesia with propofol for induction and maintenance.
322198|NCT01191476|P1|Participant Flow|Sevoflurane|Inhalational induction and maintenance anesthesia with sevoflurane.
322199|NCT01191476|O3|Outcome|Propofol Induction Sevoflurane Maintenance|Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
322200|NCT01191476|O2|Outcome|Propofol|IV propofol for induction and maintenance of anesthesia
322201|NCT01191476|O1|Outcome|Sevoflurane|Inhalational sevoflurane for induction and maintenance of anesthesia
322202|NCT01191476|O3|Outcome|Propofol Induction and Sevoflurane Maintenance|Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
322203|NCT01191476|O2|Outcome|Propofol|IV propofol for induction and maintenance of anesthesia
322204|NCT01191476|O1|Outcome|Sevoflurane|Inhalational sevoflurane for induction and maintenance of anesthesia
322205|NCT01191476|O3|Outcome|Propofol Induction Sevoflurane Maintenance|Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
322206|NCT01191476|O2|Outcome|Propofol|IV propofol for induction and maintenance of anesthesia
322207|NCT01191476|O1|Outcome|Sevoflurane|Inhalational sevoflurane for induction and maintenance of anesthesia
322208|NCT01191476|O3|Outcome|Propofol Induction Sevoflurane Maintenance|Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
322209|NCT01191476|O2|Outcome|Propofol|IV propofol for induction and maintenance of anesthesia
322210|NCT01191476|O1|Outcome|Sevoflurane|Inhalational sevoflurane for induction and maintenance of anesthesia
322211|NCT01191476|O3|Outcome|Propofol Induction Sevoflurane Maintenance|Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
322212|NCT01191476|O2|Outcome|Propofol|IV Propofol for induction and maintenance of anesthesia
322213|NCT01191476|O1|Outcome|Sevoflurane|Inhalational sevoflurane for induction and maintenance of anesthesia
322214|NCT01191476|E3|Reported Event|Propofol Induction Sevoflurane Maintenance|Propofol induction and sevoflurane maintenance anesthesia.
322215|NCT01191476|E2|Reported Event|Propofol|Target controlled infusion anesthesia with propofol for induction and maintenance.
322216|NCT01191476|E1|Reported Event|Sevoflurane|Inhalational induction and maintenance anesthesia with sevoflurane.
322217|NCT01191411|B4|Baseline|Total|Total of all reporting groups
322218|NCT01191411|B3|Baseline|Visit Based Care|"No invitation to complete colorectal cancer screening.~Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.~Visit Based Care: Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would."
322219|NCT01191411|B2|Baseline|Mailed Invitations for a Colonoscopy|"Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.~Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.~Mailed invitations for a colonoscopy: These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital."
322220|NCT01191411|B1|Baseline|Mailed Invitations for FIT Test Kits|"Fecal Immunochemical Tests (FIT) kits from Polymedco Incorporated are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.~Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.~Mailed invitations for FIT test kits: Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test."
322221|NCT01191411|P3|Participant Flow|Visit Based Care|"No invitation to complete colorectal cancer screening.~Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.~Visit Based Care: Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would."
322222|NCT01191411|P2|Participant Flow|Mailed Invitations for a Colonoscopy|"Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.~Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.~Mailed invitations for a colonoscopy: These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital."
322223|NCT01191411|P1|Participant Flow|Mailed Invitations for FIT Test Kits|"Fecal Immunochemical Tests (FIT) kits from Polymedco Incorporated are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.~Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.~Mailed invitations for FIT test kits: Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test."
322224|NCT01191411|O3|Outcome|Visit Based Care|"No invitation to complete colorectal cancer screening.~Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.~Visit Based Care: Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would."
322225|NCT01191411|O2|Outcome|Mailed Invitations for a Colonoscopy|"Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.~Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.~Mailed invitations for a colonoscopy: These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital."
322226|NCT01191411|O1|Outcome|Mailed Invitations for FIT Test Kits|"Fecal Immunochemical Tests (FIT) kits from Polymedco are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.~Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.~Mailed invitations for FIT test kits: Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test."
322227|NCT01191411|E3|Reported Event|Visit Based Care|"No invitation to complete colorectal cancer screening.~Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.~Visit Based Care: Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would."
322228|NCT01191411|E2|Reported Event|Mailed Invitations for a Colonoscopy|"Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.~Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.~Mailed invitations for a colonoscopy: These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital."
322256|NCT01191333|O1|Outcome|Active rTMS|"Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
322257|NCT01191333|O2|Outcome|Sham rTMS|"Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.~Sham Device: Placebo Device that simulates active rTMS treatment"
322599|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
322229|NCT01191411|E1|Reported Event|Mailed Invitations for FIT Test Kits|"Fecal Immunochemical Tests (FIT) kits from Polymedco Incorporated are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.~Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.~Mailed invitations for FIT test kits: Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test."
322230|NCT01191398|B4|Baseline|Total|Total of all reporting groups
322231|NCT01191398|B3|Baseline|Glycopyrrolate|Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
322232|NCT01191398|B2|Baseline|Atropine|Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
322233|NCT01191398|B1|Baseline|Placebo|"Normal Saline0.9% will act as a placebo.~Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine"
322234|NCT01191398|P3|Participant Flow|Glycopyrrolate|Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
322235|NCT01191398|P2|Participant Flow|Atropine|Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
322236|NCT01191398|P1|Participant Flow|Placebo|"Normal Saline0.9% will act as a placebo.~Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine"
322237|NCT01191398|O3|Outcome|Glycopyrrolate|Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
322238|NCT01191398|O2|Outcome|Atropine|Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
322239|NCT01191398|O1|Outcome|Placebo|"Normal Saline0.9% will act as a placebo.~Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine"
322240|NCT01191398|O3|Outcome|Glycopyrrolate|Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
322241|NCT01191398|O2|Outcome|Atropine|Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
322242|NCT01191398|O1|Outcome|Placebo|"Normal Saline0.9% will act as a placebo.~Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine"
322243|NCT01191398|E3|Reported Event|Glycopyrrolate|Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
322244|NCT01191398|E2|Reported Event|Atropine|Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
322245|NCT01191398|E1|Reported Event|Placebo|"Normal Saline0.9% will act as a placebo.~Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine"
322246|NCT01191333|B3|Baseline|Total|Total of all reporting groups
322247|NCT01191333|B2|Baseline|Sham rTMS|"Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.~Sham Device: Placebo Device that simulates active rTMS treatment"
322248|NCT01191333|B1|Baseline|Active rTMS|"Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
322249|NCT01191333|P2|Participant Flow|Sham rTMS|"Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.~Sham Device: Placebo Device that simulates active rTMS treatment"
322250|NCT01191333|P1|Participant Flow|Active rTMS|"Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
322251|NCT01191333|O2|Outcome|Sham rTMS|"Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.~Sham Device: Placebo Device that simulates active rTMS treatment"
322252|NCT01191333|O1|Outcome|Active rTMS|"Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
322253|NCT01191333|O2|Outcome|Sham rTMS|"Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.~Sham Device: Placebo Device that simulates active rTMS treatment"
322254|NCT01191333|O1|Outcome|Active rTMS|"Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
322255|NCT01191333|O2|Outcome|Sham rTMS|"Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.~Sham Device: Placebo Device that simulates active rTMS treatment"
322600|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
322258|NCT01191333|O1|Outcome|Active rTMS|"Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
322259|NCT01191333|O2|Outcome|Sham rTMS|"Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.~Sham Device: Placebo Device that simulates active rTMS treatment"
322260|NCT01191333|O1|Outcome|Active rTMS|"Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
322261|NCT01191333|O2|Outcome|Sham rTMS|"Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.~Sham Device: Placebo Device that simulates active rTMS treatment"
322262|NCT01191333|O1|Outcome|Active rTMS|"Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
322263|NCT01191333|E2|Reported Event|Sham rTMS|"Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.~Sham Device: Placebo Device that simulates active rTMS treatment"
322264|NCT01191333|E1|Reported Event|Active rTMS|"Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
322265|NCT01191320|B4|Baseline|Total|Total of all reporting groups
322266|NCT01191320|B3|Baseline|Androxal 25 mg|"25 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
322267|NCT01191320|B2|Baseline|Androxal 12.5 mg|"12.5 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
322268|NCT01191320|B1|Baseline|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
322269|NCT01191320|P3|Participant Flow|Androxal 25 mg|"25 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
322270|NCT01191320|P2|Participant Flow|Androxal 12.5 mg|"12.5 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
322271|NCT01191320|P1|Participant Flow|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
322272|NCT01191320|O3|Outcome|Androxal 25 mg|"25 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
322273|NCT01191320|O2|Outcome|Androxal 12.5 mg|"12.5 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
322274|NCT01191320|O1|Outcome|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
322275|NCT01191320|E3|Reported Event|Androxal 25 mg|"25 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
322276|NCT01191320|E2|Reported Event|Androxal 12.5 mg|"12.5 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
322277|NCT01191320|E1|Reported Event|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
322278|NCT01191268|B4|Baseline|Total|Total of all reporting groups
322279|NCT01191268|B3|Baseline|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322280|NCT01191268|B2|Baseline|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322281|NCT01191268|B1|Baseline|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322282|NCT01191268|P3|Participant Flow|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322283|NCT01191268|P2|Participant Flow|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322284|NCT01191268|P1|Participant Flow|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322285|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322286|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322287|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322288|NCT01191268|O1|Outcome|1.5 mg or 0.75 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg) or 0.75 mg , subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322289|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322290|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322291|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322601|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
322292|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322293|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322294|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322295|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322296|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322297|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322298|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322299|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322300|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322301|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322302|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322303|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322304|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322305|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322306|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322307|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322308|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322309|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322310|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322311|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322312|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322313|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322314|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322315|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322316|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322317|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322446|NCT01191008|E1|Reported Event|Latanoprost/Timolol Maleate|Participants received latanoprost/timolol maleate fixed combination eye drops into the affected eye(s) once daily for to a maximum of 104 weeks.
322318|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322319|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322320|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322321|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322322|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322323|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322324|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322325|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322326|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322327|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322328|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322329|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322330|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322331|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322332|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322333|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322334|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322335|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322336|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322337|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322338|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322339|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322340|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322341|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322342|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322343|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322398|NCT01191255|O3|Outcome|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
322344|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322345|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322346|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322347|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322348|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322349|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322350|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322351|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322352|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322353|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322354|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322355|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322356|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322357|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322358|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322359|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322360|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322361|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322362|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322363|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322364|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322365|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322366|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322367|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322368|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322369|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322445|NCT01191008|O1|Outcome|Latanoprost/Timolol Maleate|Participants received latanoprost/timolol maleate fixed combination eye drops into the affected eye(s) once daily for to a maximum of 104 weeks.
322370|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322371|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322372|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322373|NCT01191268|E3|Reported Event|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322374|NCT01191268|E2|Reported Event|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322375|NCT01191268|E1|Reported Event|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
322376|NCT01191255|B5|Baseline|Total|Total of all reporting groups
322377|NCT01191255|B4|Baseline|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
322378|NCT01191255|B3|Baseline|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
322379|NCT01191255|B2|Baseline|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.~Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
322380|NCT01191255|B1|Baseline|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
322381|NCT01191255|P4|Participant Flow|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
322382|NCT01191255|P3|Participant Flow|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
322383|NCT01191255|P2|Participant Flow|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.~Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
322384|NCT01191255|P1|Participant Flow|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
322385|NCT01191255|O4|Outcome|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
322386|NCT01191255|O3|Outcome|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
322387|NCT01191255|O2|Outcome|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.~Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
322388|NCT01191255|O1|Outcome|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
322389|NCT01191255|O4|Outcome|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
322390|NCT01191255|O3|Outcome|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
322391|NCT01191255|O2|Outcome|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.~Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
322392|NCT01191255|O1|Outcome|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
322393|NCT01191255|O4|Outcome|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
322394|NCT01191255|O3|Outcome|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
322395|NCT01191255|O2|Outcome|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.~Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
322396|NCT01191255|O1|Outcome|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
322397|NCT01191255|O4|Outcome|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
322447|NCT01190891|B3|Baseline|Total|Total of all reporting groups
322399|NCT01191255|O2|Outcome|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.~Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
322400|NCT01191255|O1|Outcome|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
322401|NCT01191255|O4|Outcome|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
322402|NCT01191255|O3|Outcome|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
322403|NCT01191255|O2|Outcome|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.~Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
322404|NCT01191255|O1|Outcome|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
322405|NCT01191255|E4|Reported Event|Placebo (EAP)|Efficacy Assessment Period (Week 52-56)
322406|NCT01191255|E3|Reported Event|KRX-0502 (EAP)|Efficacy Assessment Period (Week 52-56)
322407|NCT01191255|E2|Reported Event|Active Control (SAP)|Safety Assessment Period (Week 1-52)
322408|NCT01191255|E1|Reported Event|KRX-0502 (SAP)|Safety Assessment Period (Week 1-52)
322409|NCT01191242|B1|Baseline|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
322410|NCT01191242|P1|Participant Flow|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
322411|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
322412|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
322413|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
322414|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
322415|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
322416|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
322417|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
322418|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
322419|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
322420|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
322421|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
322422|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
322423|NCT01191242|E1|Reported Event|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
322424|NCT01191190|B1|Baseline|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
322425|NCT01191190|P1|Participant Flow|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
322426|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
322427|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
322428|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
322429|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
322430|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
322431|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
322432|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
322433|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
322434|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
322435|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
322436|NCT01191190|E1|Reported Event|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
322437|NCT01191086|B1|Baseline|Open-label USL255|"Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day~USL255"
322438|NCT01191086|P1|Participant Flow|Open-label USL255|"Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day~USL255"
322439|NCT01191086|O1|Outcome|Open-label USL255|"Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day~USL255"
322440|NCT01191086|E1|Reported Event|Open-label USL255|"Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day~USL255"
322441|NCT01191008|B1|Baseline|Latanoprost/Timolol Maleate|Participants received latanoprost/timolol maleate fixed combination eye drops into the affected eye(s) once daily for to a maximum of 104 weeks.
322442|NCT01191008|P1|Participant Flow|Latanoprost/Timolol Maleate|Participants received latanoprost/timolol maleate fixed combination eye drops into the affected eye(s) once daily for to a maximum of 104 weeks.
322443|NCT01191008|O1|Outcome|Latanoprost/Timolol Maleate|Participants received latanoprost/timolol maleate fixed combination eye drops into the affected eye(s) once daily for to a maximum of 104 weeks.
322444|NCT01191008|O1|Outcome|Latanoprost/Timolol Maleate|Participants received latanoprost/timolol maleate fixed combination eye drops into the affected eye(s) once daily for to a maximum of 104 weeks.
322448|NCT01190891|B2|Baseline|Corticosteroid Injection (Subacromial)|"Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL~Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg)."
322449|NCT01190891|B1|Baseline|Manual Physical Therapy|Manual Physical Therapy: Same as arm description
322450|NCT01190891|P2|Participant Flow|Corticosteroid Injection (Subacromial)|"Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL~Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg)."
322451|NCT01190891|P1|Participant Flow|Manual Physical Therapy|"The orthopaedic manual physical therapy (OMPT) intervention approach used in this study was based on an impairment model. The physical therapist providing the intervention addressed impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients received procedures tailored to their specific impairments. Procedures included mobilizations and manipulations of the joint and soft-tissues.~Manual Physical Therapy: Same as arm description"
322452|NCT01190891|O2|Outcome|Corticosteroid Injection (Subacromial)|"Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL~Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg)."
322453|NCT01190891|O1|Outcome|Manual Physical Therapy|"The orthopaedic manual physical therapy (OMPT) intervention approach used in this study was based on an impairment model. The physical therapist providing the intervention addressed impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients received procedures tailored to their specific impairments. Procedures included mobilizations and manipulations of the joint and soft-tissues.~Manual Physical Therapy: Same as arm description"
322454|NCT01190891|O2|Outcome|Corticosteroid Injection (Subacromial)|"Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL~Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg)."
322455|NCT01190891|O1|Outcome|Manual Physical Therapy|"The orthopaedic manual physical therapy (OMPT) intervention approach used in this study was based on an impairment model. The physical therapist providing the intervention addressed impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients received procedures tailored to their specific impairments. Procedures included mobilizations and manipulations of the joint and soft-tissues.~Manual Physical Therapy: Same as arm description"
322456|NCT01190891|E2|Reported Event|Corticosteroid Injection (Subacromial)|"Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL~Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg)."
322457|NCT01190891|E1|Reported Event|Manual Physical Therapy|"The orthopaedic manual physical therapy (OMPT) intervention approach used in this study was based on an impairment model. The physical therapist providing the intervention addressed impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients received procedures tailored to their specific impairments. Procedures included mobilizations and manipulations of the joint and soft-tissues.~Manual Physical Therapy: Same as arm description"
322458|NCT01190878|B5|Baseline|Total|Total of all reporting groups
322459|NCT01190878|B4|Baseline|DuraSite Vehicle BID|DuraSite Vehicle: Vehicle Dosed BID
322460|NCT01190878|B3|Baseline|Xibrom BID|Xibrom™: Xibrom dosed BID
322461|NCT01190878|B2|Baseline|ISV-303 QD|ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD
322462|NCT01190878|B1|Baseline|ISV-303 BID|ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID
322463|NCT01190878|P4|Participant Flow|DuraSite Vehicle BID|DuraSite Vehicle: Vehicle dosed BID
322464|NCT01190878|P3|Participant Flow|Xibrom BID|Xibrom™: 0.09% bromfenac dosed BID
322465|NCT01190878|P2|Participant Flow|ISV-303 QD|ISV-303: 0.075% bromfenac in DuraSite dosed QD
322466|NCT01190878|P1|Participant Flow|ISV-303 BID|ISV-303: 0.075% bromfenac in DuraSite dosed BID
322467|NCT01190878|O4|Outcome|DuraSite Vehicle BID|DuraSite Vehicle: Vehicle Dosed BID
322468|NCT01190878|O3|Outcome|Xibrom BID|Xibrom™: Xibrom dosed BID
322469|NCT01190878|O2|Outcome|ISV-303 QD|ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD
322470|NCT01190878|O1|Outcome|ISV-303 BID|ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID
322471|NCT01190878|E4|Reported Event|DuraSite Vehicle BID|DuraSite Vehicle: Vehicle Dosed BID
322472|NCT01190878|E3|Reported Event|Xibrom BID|Xibrom™: Xibrom dosed BID
322473|NCT01190878|E2|Reported Event|ISV-303 QD|ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD
322474|NCT01190878|E1|Reported Event|ISV-303 BID|ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID
322475|NCT01190865|B1|Baseline|HP802-247|"Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days~HP802-247: One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin."
322476|NCT01190865|P1|Participant Flow|HP802-247|"Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days~HP802-247: One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin."
322477|NCT01190865|O1|Outcome|HP802-247|"Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days~HP802-247: One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin."
322478|NCT01190865|O1|Outcome|HP802-247|"Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days~HP802-247: One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin."
322479|NCT01190865|E1|Reported Event|HP802-247|"Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days~HP802-247: One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin."
322480|NCT01190839|B3|Baseline|Total|Total of all reporting groups
322481|NCT01190839|B2|Baseline|Infliximab 5 mg/kg|Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
322482|NCT01190839|B1|Baseline|Placebo|Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
322483|NCT01190839|P2|Participant Flow|Infliximab 5 mg/kg|Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
322484|NCT01190839|P1|Participant Flow|Placebo|Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
322485|NCT01190839|O2|Outcome|Infliximab 5 mg/kg|Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
322486|NCT01190839|O1|Outcome|Placebo|Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
322487|NCT01190839|O2|Outcome|Infliximab 5 mg/kg|Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
322488|NCT01190839|O1|Outcome|Placebo|Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
322489|NCT01190839|O2|Outcome|Infliximab 5 mg/kg|Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
322490|NCT01190839|O1|Outcome|Placebo|Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
322491|NCT01190839|E4|Reported Event|First Infliximab 5 mg/kg Then Infliximab 10 mg/kg|Participants had a protocol defined dose increase from infliximab 5 mg/kg to infliximab 10 mg/kg. Only safety results after the dose increase were included in this group.
322492|NCT01190839|E3|Reported Event|First Placebo Then Infliximab 5 mg/kg|Participants had a protocol defined dose increase from Placebo to infliximab 5 mg/kg. Only safety results after start of infliximab were included in this group.
322493|NCT01190839|E2|Reported Event|Infliximab 5 mg/kg|Participants treated with Infliximab 5 mg/kg at any time through the final visit or through a protocol defined dose increase. If a participants had a protocol defined dose increase, only safety results prior to the dose increase will be included in this group.
322494|NCT01190839|E1|Reported Event|Placebo|Participants treated with placebo through the final visit or through a protocol defined dose increase. If a participant had a protocol defined dose increase, only safety results prior to the dose increase will be included in this group.
322495|NCT01190813|B3|Baseline|Total|Total of all reporting groups
322496|NCT01190813|B2|Baseline|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322497|NCT01190813|B1|Baseline|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322498|NCT01190813|P2|Participant Flow|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322499|NCT01190813|P1|Participant Flow|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322500|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322501|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322502|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322503|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322504|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322505|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322506|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322507|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322508|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322509|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322510|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322511|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322512|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322513|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322514|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322688|NCT01190267|B3|Baseline|Total|Total of all reporting groups
322515|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322516|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322517|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322518|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322519|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322520|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322521|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322522|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322523|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322524|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322525|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322526|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322527|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322528|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322529|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322530|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322531|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322532|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322533|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322534|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322535|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322536|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322537|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322538|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322539|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322540|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322541|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322542|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322543|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322544|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322545|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322546|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322547|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322548|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322549|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322550|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322551|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322552|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322553|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322554|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322598|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
322555|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322556|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322557|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322558|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322559|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322560|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322561|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322562|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322563|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322564|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322565|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322566|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322567|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322568|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322569|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322570|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322571|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322572|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322573|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322574|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322575|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322576|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322577|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322578|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322579|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322580|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322581|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322582|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322583|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322584|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322585|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322586|NCT01190813|E2|Reported Event|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
322587|NCT01190813|E1|Reported Event|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
322588|NCT01190566|B3|Baseline|Total|Total of all reporting groups
322589|NCT01190566|B2|Baseline|Non-pCR|The presence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.
322590|NCT01190566|B1|Baseline|Pathologic Complete Responders (pCR)|The absence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.
322591|NCT01190566|P2|Participant Flow|Non-pCR|The presence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.
322592|NCT01190566|P1|Participant Flow|Pathologic Complete Responders (pCR)|The absence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.
322593|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
322594|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
322595|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
322596|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
322597|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
322602|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
322603|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
322604|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
322605|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
322606|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
322607|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
322608|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
322609|NCT01190566|O1|Outcome|Pathologic Response to Chemotherapy|Degree of pathologic response to the neoadjuvant chemotherapy
322610|NCT01190566|E2|Reported Event|Non-pCR|the presence of invasive tumor cells after surgery
322611|NCT01190566|E1|Reported Event|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
322612|NCT01190527|B1|Baseline|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
322613|NCT01190527|P1|Participant Flow|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
322614|NCT01190527|O1|Outcome|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
322615|NCT01190527|O1|Outcome|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
322616|NCT01190527|O1|Outcome|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
322617|NCT01190527|O1|Outcome|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
322618|NCT01190527|E1|Reported Event|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
322619|NCT01190514|B1|Baseline|Entire Study Population|Participants randomized to 1 of the 4 treatment sequences beginning with DVS SR 25 mg*2 Fed (A); or DVS SR 50 mg Fed (B); or DVS SR 25 mg*2 Fasted (C); or DVS SR 50 mg Fasted (D).
322620|NCT01190514|P4|Participant Flow|DVS SR 50 mg Fasted (D) First|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
322621|NCT01190514|P3|Participant Flow|DVS SR 25 mg*2 Fasted (C) First|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state (fasted 8 hours prior to dosing).
322622|NCT01190514|P2|Participant Flow|DVS SR 50 mg Fed (B) First|DVS SR 50 mg tablet on Day 1 of study period in fed state.
322623|NCT01190514|P1|Participant Flow|DVS SR 25 mg*2 Fed (A) First|Desvenlafaxine sustained release (DVS SR) formulation (PF-0212375) 25 milligrams (mg) as 2 tablets (25 mg*2) on Day 1 of study period in fed state (finished a high-fat breakfast 20 minutes prior to dosing).
322624|NCT01190514|O4|Outcome|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
322625|NCT01190514|O3|Outcome|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
322626|NCT01190514|O2|Outcome|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
322627|NCT01190514|O1|Outcome|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
322628|NCT01190514|O4|Outcome|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
322629|NCT01190514|O3|Outcome|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
322630|NCT01190514|O2|Outcome|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
322631|NCT01190514|O1|Outcome|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
322632|NCT01190514|O4|Outcome|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
322633|NCT01190514|O3|Outcome|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
322634|NCT01190514|O2|Outcome|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
322635|NCT01190514|O1|Outcome|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
322636|NCT01190514|O4|Outcome|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
322637|NCT01190514|O3|Outcome|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
322638|NCT01190514|O2|Outcome|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
322639|NCT01190514|O1|Outcome|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
322640|NCT01190514|O4|Outcome|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
322641|NCT01190514|O3|Outcome|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
322642|NCT01190514|O2|Outcome|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
322643|NCT01190514|O1|Outcome|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
322644|NCT01190514|O4|Outcome|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
322645|NCT01190514|O3|Outcome|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
322646|NCT01190514|O2|Outcome|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
322647|NCT01190514|O1|Outcome|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
322648|NCT01190514|E4|Reported Event|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
322649|NCT01190514|E3|Reported Event|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state (fasted 8 hours prior to dosing).
322650|NCT01190514|E2|Reported Event|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
322651|NCT01190514|E1|Reported Event|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state (finished a high-fat breakfast 20 minutes prior to dosing).
322652|NCT01190475|B4|Baseline|Total|Total of all reporting groups
322653|NCT01190475|B3|Baseline|Placebo|Placebo
322654|NCT01190475|B2|Baseline|BGS649 Low Dose|BGS649
322655|NCT01190475|B1|Baseline|BGS649 High Dose|BGS649
322656|NCT01190475|P3|Participant Flow|Placebo|Placebo
322657|NCT01190475|P2|Participant Flow|BGS649 Low Dose|BGS649
322658|NCT01190475|P1|Participant Flow|BGS649 High Dose|BGS649
322659|NCT01190475|O3|Outcome|Placebo|Placebo
322660|NCT01190475|O2|Outcome|BGS649 Low Dose|BGS649
322661|NCT01190475|O1|Outcome|BGS649 High Dose|BGS649
322662|NCT01190475|E3|Reported Event|Placebo|Placebo
322663|NCT01190475|E2|Reported Event|BGS649 Low Dose|BGS649
322664|NCT01190475|E1|Reported Event|BGS649 High Dose|BGS649
322665|NCT01190436|B1|Baseline|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
322666|NCT01190436|P1|Participant Flow|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
322667|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than 130/80 millimeter of mercury (mmHg) or equal to 130/80 mmHg after week, bisoprolol dose adjusted to 10 mg once daily. Duration of the treatment was 12 weeks.
322668|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
322669|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
322670|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
322671|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
322672|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
322673|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
322674|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
322675|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
322676|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
322677|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
322678|NCT01190436|E1|Reported Event|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than 130/80 millimeter of mercury (mmHg) or equal to 130/80 mmHg after week, bisoprolol dose adjusted to 10 mg once daily. Duration of the treatment was 12 weeks.
322679|NCT01190306|B3|Baseline|Total|Total of all reporting groups
322680|NCT01190306|B2|Baseline|Sham Control|Eyes in the control group will be treated with riboflavin only.
322681|NCT01190306|B1|Baseline|CXL Treatment|Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
322682|NCT01190306|P2|Participant Flow|Sham Control|Eyes in the control group will be treated with riboflavin only.
322683|NCT01190306|P1|Participant Flow|CXL Treatment|Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
322684|NCT01190306|O2|Outcome|Sham Control|Eyes in the control group will be treated with riboflavin only.
322685|NCT01190306|O1|Outcome|CXL Treatment|Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
322686|NCT01190306|E2|Reported Event|Sham Control|Eyes in the control group will be treated with riboflavin only.
322687|NCT01190306|E1|Reported Event|CXL Treatment|Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
322689|NCT01190267|B2|Baseline|Asenapine - Participants Who Were 18 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
322690|NCT01190267|B1|Baseline|Asenapine - Participants Who Were ≤17 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.
322691|NCT01190267|P2|Participant Flow|Asenapine - Participants Who Were 18 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
322692|NCT01190267|P1|Participant Flow|Asenapine - Participants Who Were ≤17 Years Old|In this extension study all participants received open-label asenapine 2.5 mg twice daily (BID) on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.
322693|NCT01190267|O2|Outcome|Asenapine - Participants Who Were 18 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
322694|NCT01190267|O1|Outcome|Asenapine - Participants Who Were ≤17 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.
322695|NCT01190267|O2|Outcome|Asenapine - Participants Who Were 18 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
322696|NCT01190267|O1|Outcome|Asenapine - Participants Who Were ≤17 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.
322697|NCT01190267|E2|Reported Event|Asenapine - Participants Who Were 18 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
322698|NCT01190267|E1|Reported Event|Asenapine - Participants Who Were ≤17 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.
322699|NCT01190254|B4|Baseline|Total|Total of all reporting groups
322700|NCT01190254|B3|Baseline|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
322701|NCT01190254|B2|Baseline|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
322702|NCT01190254|B1|Baseline|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
322703|NCT01190254|P3|Participant Flow|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
322704|NCT01190254|P2|Participant Flow|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
322705|NCT01190254|P1|Participant Flow|Placebo|Participants receive placebo asenapine tablets sublingually twice daily (BID) for 8 weeks
322706|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
322707|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
322708|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
322709|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
322710|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
322711|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
322712|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
322713|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
322714|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
322715|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
322716|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
322717|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
322718|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
322719|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
322720|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
322721|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
322722|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
322723|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
322724|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
322725|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
322726|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
322727|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
322728|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
322729|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
322730|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
322731|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
322732|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
322733|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
322734|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
322735|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
322736|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
322737|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
322738|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
322739|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
322740|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
322741|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
322742|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
322743|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
322744|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
322745|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
322746|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
322747|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
322748|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
322749|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
322750|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
322751|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
322752|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
322753|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
322754|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
322755|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
322756|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
322757|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
322758|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
322759|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
322760|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
322761|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
322762|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
322763|NCT01190254|E3|Reported Event|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
322764|NCT01190254|E2|Reported Event|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
322765|NCT01190254|E1|Reported Event|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
322766|NCT01190228|B4|Baseline|Total|Total of all reporting groups
322767|NCT01190228|B3|Baseline|Varicella Vaccine Group|JE vaccine naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group).
322768|NCT01190228|B2|Baseline|JE-CV Vaccine First Dose|JE vaccine naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
322769|NCT01190228|B1|Baseline|JE-CV Vaccine Booster|Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
322770|NCT01190228|P3|Participant Flow|Varicella Vaccine Group|JE vaccine naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group).
322771|NCT01190228|P2|Participant Flow|JE-CV Vaccine First Dose|JE vaccine naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
322772|NCT01190228|P1|Participant Flow|JE-CV Vaccine Booster|Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
322773|NCT01190228|O3|Outcome|Varicella Vaccine Group|JE naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group).
322774|NCT01190228|O2|Outcome|JE-CV First Dose|JE naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
322775|NCT01190228|O1|Outcome|JE-CV Booster|Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
322776|NCT01190228|O1|Outcome|JE-CV Booster|Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial
322777|NCT01190228|O1|Outcome|JE-CV Booster|Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
322778|NCT01190228|O1|Outcome|JE-CV Booster|Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
322779|NCT01190228|O2|Outcome|JE-CV First Dose|JE naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
322780|NCT01190228|O1|Outcome|JE-CV Booster|Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
322781|NCT01190228|O2|Outcome|JE-CV First Dose|JE naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
322782|NCT01190228|O1|Outcome|JE-CV Booster|Participants previously received a single dose of JE-CV Vaccine in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
322783|NCT01190228|O2|Outcome|JE-CV First Dose|JE naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
322784|NCT01190228|O1|Outcome|JE-CV Booster|Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
324219|NCT01187355|B1|Baseline|Alcon MPDS|Multi-purpose disinfecting contact lens solution
322785|NCT01190228|O2|Outcome|JE-CV First Dose|JE naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
322786|NCT01190228|O1|Outcome|JE-CV Booster|Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
322787|NCT01190228|O2|Outcome|JE-CV First Dose|JE naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
322788|NCT01190228|O1|Outcome|JE-CV Booster|Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
322789|NCT01190228|E3|Reported Event|Varicella Vaccine Group|JE vaccine naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group).
322790|NCT01190228|E2|Reported Event|JE-CV Vaccine First Dose|JE vaccine naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
322791|NCT01190228|E1|Reported Event|JE-CV Vaccine Booster|Participants previously received a single dose of JE-CV Vaccine in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
322792|NCT01190215|B3|Baseline|Total|Total of all reporting groups
322793|NCT01190215|B2|Baseline|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322794|NCT01190215|B1|Baseline|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322795|NCT01190215|P2|Participant Flow|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322796|NCT01190215|P1|Participant Flow|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322797|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322798|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322799|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322800|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322801|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322802|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322803|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322804|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322805|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322806|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322807|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322808|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322809|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322810|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322811|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
323106|NCT01189604|O7|Outcome|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
322812|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322813|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322814|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322815|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322816|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322817|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322818|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322819|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322820|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322821|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322822|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322823|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322824|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322825|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322826|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322827|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322828|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322829|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322830|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322831|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322832|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322833|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322834|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322835|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
323107|NCT01189604|O6|Outcome|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
322836|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322837|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322838|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322839|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322840|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322841|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322842|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322843|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322844|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322845|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322846|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322847|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322848|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322849|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322850|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322851|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322852|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322853|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322854|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322855|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322856|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322857|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322858|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322859|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
323108|NCT01189604|O5|Outcome|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
322860|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322861|NCT01190215|E2|Reported Event|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322862|NCT01190215|E1|Reported Event|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
322863|NCT01190150|B3|Baseline|Total|Total of all reporting groups
322864|NCT01190150|B2|Baseline|1.3 g / 0.65 g Tranexamic Acid|Participants received a single dose of 1.3 g tranexamic acid on Day 1 and a single dose of 0.65 g tranexamic acid on Day 8.
322865|NCT01190150|B1|Baseline|0.65 g / 1.3 g Tranexamic Acid|Participants received a single dose of 0.65 g tranexamic acid on Day 1 and a single dose of 1.3 g tranexamic acid on Day 8.
322866|NCT01190150|P2|Participant Flow|1.3 g / 0.65 g Tranexamic Acid|Participants received a single dose of 1.3 g tranexamic acid on Day 1 and a single dose of 0.65 g tranexamic acid on Day 8.
322867|NCT01190150|P1|Participant Flow|0.65 g / 1.3 g Tranexamic Acid|Participants received a single dose of 0.65 g tranexamic acid on Day 1 and a single dose of 1.3 g tranexamic acid on Day 8.
322868|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
322869|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
322870|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
322871|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
322872|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
322873|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
322874|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
322875|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
322876|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
322877|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
322878|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
322879|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
322880|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
322881|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
322882|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
322883|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
322884|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
322885|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
322886|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
322887|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
322888|NCT01190150|E2|Reported Event|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
322889|NCT01190150|E1|Reported Event|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
322890|NCT01190124|B4|Baseline|Total|Total of all reporting groups
322891|NCT01190124|B3|Baseline|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
322892|NCT01190124|B2|Baseline|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
322893|NCT01190124|B1|Baseline|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
322894|NCT01190124|P3|Participant Flow|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
322895|NCT01190124|P2|Participant Flow|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
322896|NCT01190124|P1|Participant Flow|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
322897|NCT01190124|O1|Outcome|Total|Total number of patients studied
322898|NCT01190124|O3|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
322899|NCT01190124|O2|Outcome|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
322900|NCT01190124|O1|Outcome|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
322901|NCT01190124|O3|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
322902|NCT01190124|O2|Outcome|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
322903|NCT01190124|O1|Outcome|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
322904|NCT01190124|O1|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure
322905|NCT01190124|O1|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure
322906|NCT01190124|O1|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure
322907|NCT01190124|O1|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure
322908|NCT01190124|O1|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure
322909|NCT01190124|O1|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure
322910|NCT01190124|O1|Outcome|HIV Patients With Therapy Replacement|HIV infected patients in whom T20 was replaced by raltegravir
322911|NCT01190124|O1|Outcome|HIV Patients With Therapy Replacement|HIV infected patients in whom T20 was replaced by raltegravir
322912|NCT01190124|O1|Outcome|HIV Patients With Therapy Replacement|HIV infected patients in whom T20 was replaced by raltegravir
322913|NCT01190124|O1|Outcome|HIV Patients With Therapy Replacement|HIV infected patients in whom T20 was replaced by raltegravir
322914|NCT01190124|O1|Outcome|HIV Patients With Therapy Replacement|HIV infected patients in whom T20 was replaced by raltegravir
322915|NCT01190124|O1|Outcome|HIV Patients With Therapy Replacement|HIV infected patients in whom T20 was replaced by raltegravir
322916|NCT01190124|O3|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
322917|NCT01190124|O2|Outcome|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
322918|NCT01190124|O1|Outcome|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
322919|NCT01190124|O3|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
322920|NCT01190124|O2|Outcome|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
322921|NCT01190124|O1|Outcome|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
322922|NCT01190124|O3|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
322923|NCT01190124|O2|Outcome|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
322924|NCT01190124|O1|Outcome|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
322925|NCT01190124|O3|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
322926|NCT01190124|O2|Outcome|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
322927|NCT01190124|O1|Outcome|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
322928|NCT01190124|E3|Reported Event|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
322929|NCT01190124|E2|Reported Event|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
322930|NCT01190124|E1|Reported Event|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
322931|NCT01190098|B3|Baseline|Total|Total of all reporting groups
322932|NCT01190098|B2|Baseline|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
322933|NCT01190098|B1|Baseline|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
322934|NCT01190098|P2|Participant Flow|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
322935|NCT01190098|P1|Participant Flow|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
322936|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
322937|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
322938|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
322939|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
322940|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
322941|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
322942|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
322943|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
322944|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
322945|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
322946|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
322947|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
322948|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
322949|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
322950|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
322951|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
322952|NCT01190098|E2|Reported Event|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
322953|NCT01190098|E1|Reported Event|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
322954|NCT01190085|B4|Baseline|Total|Total of all reporting groups
322955|NCT01190085|B3|Baseline|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
322956|NCT01190085|B2|Baseline|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
322957|NCT01190085|B1|Baseline|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
322958|NCT01190085|P3|Participant Flow|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
322959|NCT01190085|P2|Participant Flow|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
322960|NCT01190085|P1|Participant Flow|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
322961|NCT01190085|O3|Outcome|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
322962|NCT01190085|O2|Outcome|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
322963|NCT01190085|O1|Outcome|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
322964|NCT01190085|O3|Outcome|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
322965|NCT01190085|O2|Outcome|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
322966|NCT01190085|O1|Outcome|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
322967|NCT01190085|O3|Outcome|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
322968|NCT01190085|O2|Outcome|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
322969|NCT01190085|O1|Outcome|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
322970|NCT01190085|E3|Reported Event|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
322971|NCT01190085|E2|Reported Event|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
322972|NCT01190085|E1|Reported Event|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
323109|NCT01189604|O4|Outcome|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
322973|NCT01190007|B1|Baseline|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
322974|NCT01190007|P1|Participant Flow|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
322975|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
322976|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
322977|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
322978|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
322979|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
322980|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
322981|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
322982|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
322983|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
322984|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
323025|NCT01189760|P2|Participant Flow|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
322985|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
322986|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
322987|NCT01190007|E1|Reported Event|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
322988|NCT01189890|B3|Baseline|Total|Total of all reporting groups
322989|NCT01189890|B2|Baseline|Glimepiride|Glimepiride 1-6 mg QD
322990|NCT01189890|B1|Baseline|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
322991|NCT01189890|P2|Participant Flow|Glimepiride|Glimepiride 1-6 mg QD
322992|NCT01189890|P1|Participant Flow|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
322993|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
322994|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
322995|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
322996|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
322997|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
322998|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
322999|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
323000|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
323001|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
323002|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
323003|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
323004|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
323005|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
323006|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
323007|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
323008|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
323009|NCT01189890|E2|Reported Event|Glimepiride|Glimepiride 1-6 mg QD
323010|NCT01189890|E1|Reported Event|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
323011|NCT01189812|B3|Baseline|Total|Total of all reporting groups
323012|NCT01189812|B2|Baseline|Lithium|Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning.
323013|NCT01189812|B1|Baseline|Placebo (Sugar Pill)|Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning.
323014|NCT01189812|P2|Participant Flow|Lithium|Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning.
323015|NCT01189812|P1|Participant Flow|Placebo (Sugar Pill)|Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning.
323016|NCT01189812|O2|Outcome|Lithium|Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning.
323017|NCT01189812|O1|Outcome|Placebo (Sugar Pill)|Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning.
323018|NCT01189812|E2|Reported Event|Lithium|Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning.
323019|NCT01189812|E1|Reported Event|Placebo (Sugar Pill)|Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning.
323020|NCT01189760|B4|Baseline|Total|Total of all reporting groups
323021|NCT01189760|B3|Baseline|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323022|NCT01189760|B2|Baseline|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323023|NCT01189760|B1|Baseline|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323024|NCT01189760|P3|Participant Flow|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323103|NCT01189604|P3|Participant Flow|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
323026|NCT01189760|P1|Participant Flow|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323027|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323028|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323029|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323030|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323031|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323032|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323033|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323034|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323035|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323036|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323037|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323038|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323039|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323040|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323041|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323042|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323043|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323044|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323045|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323046|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323047|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323048|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323049|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323050|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323051|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323052|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323053|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323054|NCT01189760|E3|Reported Event|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323104|NCT01189604|P2|Participant Flow|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
323055|NCT01189760|E2|Reported Event|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323056|NCT01189760|E1|Reported Event|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
323057|NCT01189747|B3|Baseline|Total|Total of all reporting groups
323058|NCT01189747|B2|Baseline|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
323059|NCT01189747|B1|Baseline|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
323060|NCT01189747|P2|Participant Flow|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
323061|NCT01189747|P1|Participant Flow|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
323062|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
323063|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
323064|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
323065|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
323066|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
323067|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
323068|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
323069|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
323070|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
323071|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
323072|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
323073|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
323074|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
323075|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
323076|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
323077|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
323078|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
323079|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
323080|NCT01189747|E2|Reported Event|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
323081|NCT01189747|E1|Reported Event|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
323082|NCT01189617|B3|Baseline|Total|Total of all reporting groups
323083|NCT01189617|B2|Baseline|Female|Female Participants
323084|NCT01189617|B1|Baseline|Male|Male Participants
323085|NCT01189617|P2|Participant Flow|Female|Female Participants
323086|NCT01189617|P1|Participant Flow|Male|Male Participants
323087|NCT01189617|O2|Outcome|Female|Female Participants
323088|NCT01189617|O1|Outcome|Male|Male Participants
323089|NCT01189617|E2|Reported Event|Female|Female Participants
323090|NCT01189617|E1|Reported Event|Male|Male Participants
323091|NCT01189604|B8|Baseline|Total|Total of all reporting groups
323092|NCT01189604|B7|Baseline|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
323093|NCT01189604|B6|Baseline|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
323094|NCT01189604|B5|Baseline|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
323095|NCT01189604|B4|Baseline|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
323096|NCT01189604|B3|Baseline|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
323097|NCT01189604|B2|Baseline|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
323098|NCT01189604|B1|Baseline|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
323099|NCT01189604|P7|Participant Flow|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
323100|NCT01189604|P6|Participant Flow|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
323101|NCT01189604|P5|Participant Flow|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
323102|NCT01189604|P4|Participant Flow|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
323105|NCT01189604|P1|Participant Flow|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
323110|NCT01189604|O3|Outcome|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
323111|NCT01189604|O2|Outcome|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
323112|NCT01189604|O1|Outcome|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
323113|NCT01189604|O7|Outcome|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
323114|NCT01189604|O6|Outcome|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
323115|NCT01189604|O5|Outcome|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
323116|NCT01189604|O4|Outcome|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
323117|NCT01189604|O3|Outcome|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
323118|NCT01189604|O2|Outcome|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
323119|NCT01189604|O1|Outcome|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
323120|NCT01189604|O7|Outcome|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
323121|NCT01189604|O6|Outcome|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
323122|NCT01189604|O5|Outcome|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
323123|NCT01189604|O4|Outcome|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
323124|NCT01189604|O3|Outcome|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
323125|NCT01189604|O2|Outcome|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
323126|NCT01189604|O1|Outcome|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
323127|NCT01189604|O7|Outcome|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
323128|NCT01189604|O6|Outcome|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
323129|NCT01189604|O5|Outcome|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
323130|NCT01189604|O4|Outcome|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
323131|NCT01189604|O3|Outcome|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
323132|NCT01189604|O2|Outcome|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
323133|NCT01189604|O1|Outcome|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
323134|NCT01189604|O7|Outcome|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
323135|NCT01189604|O6|Outcome|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
323136|NCT01189604|O5|Outcome|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
323137|NCT01189604|O4|Outcome|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
323138|NCT01189604|O3|Outcome|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
323139|NCT01189604|O2|Outcome|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
323140|NCT01189604|O1|Outcome|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
323141|NCT01189604|E7|Reported Event|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
323142|NCT01189604|E6|Reported Event|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
323143|NCT01189604|E5|Reported Event|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
323144|NCT01189604|E4|Reported Event|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
323145|NCT01189604|E3|Reported Event|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
323146|NCT01189604|E2|Reported Event|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
323147|NCT01189604|E1|Reported Event|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
323148|NCT01189500|B1|Baseline|Tamoxifen 40 mg, Tamoxifen 40 mg + DVS SR 100 mg|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. DVS SR 100 mg as a single oral dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323149|NCT01189500|P1|Participant Flow|Tamoxifen 40 mg, Tamoxifen 40 mg + DVS SR 100 mg|Tamoxifen (TAMOX) 40 milligrams (mg) as a single oral dose Period 1 / Day 1. Desvenlafaxine sustained release (DVS SR) 100 mg as a single oral dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323185|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323150|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323151|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323152|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323153|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323154|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323155|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323156|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323157|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323158|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323159|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323160|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323161|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323162|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323163|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323164|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323165|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323166|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323167|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323168|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323169|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323170|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323171|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323172|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323173|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323174|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323175|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323176|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323177|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323178|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323179|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323180|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323181|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323182|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323183|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323184|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323186|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323187|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323188|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323189|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323190|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323191|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323192|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323193|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323194|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323195|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323196|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323197|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323198|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323199|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323200|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323201|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323202|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323203|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323204|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323205|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
323206|NCT01189500|E3|Reported Event|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|Tamoxifen 40 mg as a single oral dose coadministered with DVS SR 100 mg as a single oral dose on Period 2 / Day 7.
323207|NCT01189500|E2|Reported Event|DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28.
323208|NCT01189500|E1|Reported Event|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose on Period 1 / Day 1.
323209|NCT01189487|B1|Baseline|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
323210|NCT01189487|P1|Participant Flow|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
323211|NCT01189487|O1|Outcome|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
323212|NCT01189487|O1|Outcome|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
323213|NCT01189487|O1|Outcome|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
323214|NCT01189487|O1|Outcome|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
323215|NCT01189487|O1|Outcome|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
323216|NCT01189487|E1|Reported Event|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
323217|NCT01189461|B1|Baseline|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
323218|NCT01189461|P1|Participant Flow|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
323219|NCT01189461|O1|Outcome|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
323220|NCT01189461|O1|Outcome|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
323221|NCT01189461|O1|Outcome|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
323222|NCT01189461|O1|Outcome|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
323223|NCT01189461|E1|Reported Event|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
323224|NCT01189435|B1|Baseline|Erlotinib|"This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.~erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST."
323225|NCT01189435|P1|Participant Flow|Erlotinib|"This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.~erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST."
323226|NCT01189435|O1|Outcome|Erlotinib|"This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.~erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST."
323227|NCT01189435|E1|Reported Event|Erlotinib|"This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.~erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST."
323228|NCT01189370|B1|Baseline|Sorafenib|"Sorafenib 400 mg twice daily, 7 days a week~Sorafenib 600 mg twice daily, days 1-5 per week~Sorafenib 800 mg twice daily, days 1-5 per week~Sorafenib 1000 mg twice daily, says 1-5 per week"
323229|NCT01189370|P3|Participant Flow|Cohort 3: 800mg|Participants were administered 800mg of Sorafenib by mouth twice daily, days 1-5 of each week for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
323230|NCT01189370|P2|Participant Flow|Cohort 2: 600 mg|Participants were administered 600mg of Sorafenib by mouth twice daily, days 1-5 of each week for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
323231|NCT01189370|P1|Participant Flow|Cohort 1: 400mg|Participants were administered 400 mg of Sorafenib by mouth twice daily for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
323232|NCT01189370|O1|Outcome|Number of Participants With Disease Progression|Total number of participants that had disease progression while on study. Disease progression based on RECIST criteria.
323233|NCT01189370|O3|Outcome|Cohort 3: 800mg|Participants were administered 800mg of Sorafenib by mouth twice daily, days 1-5 of each week for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
323234|NCT01189370|O2|Outcome|Cohort 2: 600 mg|Participants were administered 600mg of Sorafenib by mouth twice daily, days 1-5 of each week for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
323235|NCT01189370|O1|Outcome|Cohort 1: 400mg|Participants were administered 400 mg of Sorafenib by mouth twice daily for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
323236|NCT01189370|E1|Reported Event|Sorafenib|"Sorafenib 400 mg twice daily, 7 days a week~Sorafenib 600 mg twice daily, days 1-5 per week~Sorafenib 800 mg twice daily, days 1-5 per week"
323237|NCT01189292|B3|Baseline|Total|Total of all reporting groups
323238|NCT01189292|B2|Baseline|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
323239|NCT01189292|B1|Baseline|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
323240|NCT01189292|P2|Participant Flow|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
323241|NCT01189292|P1|Participant Flow|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
323242|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
323243|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
323244|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
323245|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
323246|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
323247|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
323248|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
323249|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
323250|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
323251|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
323252|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
323253|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
323254|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
323255|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
323256|NCT01189292|E2|Reported Event|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
323257|NCT01189292|E1|Reported Event|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
323258|NCT01189279|B4|Baseline|Total|Total of all reporting groups
323259|NCT01189279|B3|Baseline|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
323260|NCT01189279|B2|Baseline|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
323261|NCT01189279|B1|Baseline|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
323262|NCT01189279|P3|Participant Flow|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
323263|NCT01189279|P2|Participant Flow|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
323264|NCT01189279|P1|Participant Flow|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
323265|NCT01189279|O3|Outcome|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
323266|NCT01189279|O2|Outcome|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
323267|NCT01189279|O1|Outcome|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
323268|NCT01189279|O3|Outcome|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
323269|NCT01189279|O2|Outcome|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
323270|NCT01189279|O1|Outcome|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
323271|NCT01189279|O3|Outcome|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
323272|NCT01189279|O2|Outcome|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
323273|NCT01189279|O1|Outcome|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
323274|NCT01189279|O3|Outcome|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
323275|NCT01189279|O2|Outcome|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
323276|NCT01189279|O1|Outcome|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
323277|NCT01189279|O3|Outcome|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
323278|NCT01189279|O2|Outcome|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
323279|NCT01189279|O1|Outcome|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
323280|NCT01189279|E3|Reported Event|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
323281|NCT01189279|E2|Reported Event|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
323282|NCT01189279|E1|Reported Event|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
323283|NCT01189240|B1|Baseline|Phase I Dose Finding|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
323284|NCT01189240|P3|Participant Flow|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
323352|NCT01189201|O3|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
323353|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
323537|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323285|NCT01189240|P2|Participant Flow|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
323286|NCT01189240|P1|Participant Flow|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
323287|NCT01189240|O3|Outcome|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
323288|NCT01189240|O2|Outcome|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
323289|NCT01189240|O1|Outcome|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
323290|NCT01189240|O3|Outcome|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
323291|NCT01189240|O2|Outcome|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
323292|NCT01189240|O1|Outcome|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
323293|NCT01189240|O3|Outcome|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
323294|NCT01189240|O2|Outcome|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
323295|NCT01189240|O1|Outcome|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
323296|NCT01189240|O3|Outcome|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
323354|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
323355|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
323356|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
323297|NCT01189240|O2|Outcome|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
323298|NCT01189240|O1|Outcome|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
323299|NCT01189240|O3|Outcome|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
323300|NCT01189240|O2|Outcome|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
323301|NCT01189240|O1|Outcome|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
323302|NCT01189240|O1|Outcome|Phase I Dose Finding|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
323303|NCT01189240|E1|Reported Event|Phase I Dose Finding|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
323304|NCT01189227|B3|Baseline|Total|Total of all reporting groups
323305|NCT01189227|B2|Baseline|Perioperative Chemotherapy|Perioperative chemotherapy
323306|NCT01189227|B1|Baseline|Postoperative Chemotherapy|Postoperative chemotherapy
323307|NCT01189227|P2|Participant Flow|Arm 2: Perioperative Chemotherapy|Patients receive mFOLFOX6 or FOLFIRI chemotherapy IV over 3 hours on day 1. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats for every 2 weeks for 6 cycles. Patients then undergo hepatic resection. Beginning 31-56 days after surgery, patients receive an additional 6 cycles of mFOLFOX6 or FOLFIRI chemotherapy.
323308|NCT01189227|P1|Participant Flow|Arm 1: Postoperative Chemotherapy|Patients undergo hepatic resection. Beginning 31-56 days after surgery, patients receive mFOLFOX6 or FOLFIRI chemotherapy IV on day 1 over 3 hours. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats every 2 weeks for 12 cycles.
323309|NCT01189227|O2|Outcome|Arm 2: Perioperative Chemotherapy|Patients receive mFOLFOX6 or FOLFIRI chemotherapy IV over 3 hours on day 1. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats for every 2 weeks for 6 cycles. Patients then undergo hepatic resection. Beginning 31-56 days after surgery, patients receive an additional 6 cycles of mFOLFOX6 or FOLFIRI chemotherapy.
323310|NCT01189227|O1|Outcome|Arm 1: Postoperative Chemotherapy|Patients undergo hepatic resection. Beginning 31-56 days after surgery, patients receive mFOLFOX6 or FOLFIRI chemotherapy IV on day 1 over 3 hours. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats every 2 weeks for 12 cycles.
323311|NCT01189227|E2|Reported Event|Perioperative Chemotherapy|Perioperative chemotherapy
323312|NCT01189227|E1|Reported Event|Postoperative Chemotherapy|Postoperative chemotherapy
323313|NCT01189201|B1|Baseline|Study Overall|"A randomised, open label, three period, crossover trial. Each subject was to receive 3 of 4 possible treatments. The treatments were~Empagliflozin plus linagliptin fixed dose combination (FDC) A1 (fasted)~Empagliflozin plus linagliptin, individual tablets (fasted)~Empagliflozin plus linagliptin FDC A1 (fed)~Empagliflozin plus linagliptin FDC A3 (fasted)~Drug administrations were separated by a washout period of at least 35 days.~A total of 42 subjects were entered into the study, all subjects were allocated to the FDC A1 (fasted) and individual tablet treatments as this was the primary objective of the study. Along with this 18 of the subjects were allocated to receive the FDC A1 (fed) treatment and other 24 subjects to the FDC A3 treatment."
323357|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
323358|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
323359|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
323538|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
323314|NCT01189201|P1|Participant Flow|Study Overall|"A randomised, open label, three period, crossover trial. Each subject was to receive 3 of 4 possible treatments. The treatments were~Empagliflozin plus linagliptin fixed dose combination (FDC) A1 (fasted)~Empagliflozin plus linagliptin, individual tablets (fasted)~Empagliflozin plus linagliptin FDC A1 (fed)~Empagliflozin plus linagliptin FDC A3 (fasted)~Drug administrations were separated by a washout period of at least 35 days.~A total of 42 subjects were entered into the study, all subjects were allocated to the FDC A1 (fasted) and individual tablet treatments as this was the primary objective of the study. Along with this 18 of the subjects were allocated to receive the FDC A1 (fed) treatment and other 24 subjects to the FDC A3 treatment."
323315|NCT01189201|O4|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
323316|NCT01189201|O3|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
323317|NCT01189201|O2|Outcome|Empa Plus Linagliptin Indivdual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
323318|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
323319|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
323320|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
323321|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
323322|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
323323|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
323324|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
323325|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3.
323326|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
323327|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3.
323328|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
323329|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
323330|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
323331|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
323332|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
323333|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
323334|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
323335|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
323336|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
323337|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
323338|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
323339|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
323340|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
323341|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
323342|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
323343|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
323344|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
323345|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
323346|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
323347|NCT01189201|O4|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3.
323348|NCT01189201|O3|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
323349|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
323350|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
323351|NCT01189201|O4|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3.
323607|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
323360|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
323361|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
323362|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
323363|NCT01189201|E4|Reported Event|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
323364|NCT01189201|E3|Reported Event|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
323365|NCT01189201|E2|Reported Event|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
323366|NCT01189201|E1|Reported Event|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
323367|NCT01189136|B3|Baseline|Total|Total of all reporting groups
323368|NCT01189136|B2|Baseline|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes~PTNS treatment: Electrical stimulation is received"
323369|NCT01189136|B1|Baseline|Sham Treatment|"No electrical stimulation is actually received~Sham treatment: No electrical stimulation is given"
323370|NCT01189136|P2|Participant Flow|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes~PTNS treatment: Electrical stimulation is received"
323371|NCT01189136|P1|Participant Flow|Sham Treatment|"No electrical stimulation is actually received~Sham treatment: No electrical stimulation is given"
323372|NCT01189136|O2|Outcome|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes~PTNS treatment: Electrical stimulation is received"
323373|NCT01189136|O1|Outcome|Sham Treatment|"No electrical stimulation is actually received~Sham treatment: No electrical stimulation is given"
323374|NCT01189136|O2|Outcome|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes~PTNS treatment: Electrical stimulation is received"
323375|NCT01189136|O1|Outcome|Sham Treatment|"No electrical stimulation is actually received~Sham treatment: No electrical stimulation is given"
323376|NCT01189136|O2|Outcome|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes~PTNS treatment: Electrical stimulation is received"
323377|NCT01189136|O1|Outcome|Sham Treatment|"No electrical stimulation is actually received~Sham treatment: No electrical stimulation is given"
323378|NCT01189136|O2|Outcome|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes~PTNS treatment: Electrical stimulation is received"
323379|NCT01189136|O1|Outcome|Sham Treatment|"No electrical stimulation is actually received~Sham treatment: No electrical stimulation is given"
323380|NCT01189136|E2|Reported Event|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes~PTNS treatment: Electrical stimulation is received"
323381|NCT01189136|E1|Reported Event|Sham Treatment|"No electrical stimulation is actually received~Sham treatment: No electrical stimulation is given"
323382|NCT01189123|B3|Baseline|Total|Total of all reporting groups
323383|NCT01189123|B2|Baseline|High Dose Vaccine|"High Dose Fluzone by sanofi pasteur~High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)"
323384|NCT01189123|B1|Baseline|Standard Dose Influenza Vaccine|"Fluzone (Sanofi Pasteur)~fluzone by sanofi pasteur: standard dose fluzone"
323385|NCT01189123|P2|Participant Flow|High Dose Vaccine|"High Dose Fluzone by sanofi pasteur~High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)"
323386|NCT01189123|P1|Participant Flow|Standard Dose Influenza Vaccine|"Fluzone (Sanofi Pasteur)~fluzone by sanofi pasteur: standard dose fluzone~1 dose of vaccine was given IM"
323387|NCT01189123|O2|Outcome|High Dose Vaccine|"High Dose Fluzone by sanofi pasteur~High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)"
323388|NCT01189123|O1|Outcome|Standard Dose Influenza Vaccine|"Fluzone (Sanofi Pasteur)~fluzone by sanofi pasteur: standard dose fluzone"
323389|NCT01189123|O2|Outcome|High Dose Vaccine|"High Dose Fluzone by sanofi pasteur~High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)"
323390|NCT01189123|O1|Outcome|Standard Dose Influenza Vaccine|"Fluzone (Sanofi Pasteur)~fluzone by sanofi pasteur: standard dose fluzone"
323391|NCT01189123|E2|Reported Event|High Dose Vaccine|"High Dose Fluzone by sanofi pasteur~High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)"
323392|NCT01189123|E1|Reported Event|Standard Dose Influenza Vaccine|"Fluzone (Sanofi Pasteur)~fluzone by sanofi pasteur: standard dose fluzone"
323393|NCT01189110|B3|Baseline|Total|Total of all reporting groups
323394|NCT01189110|B2|Baseline|Arm 2|Machine B (sham treatment) will be altered to disable the electrical current to flow to the probe. Otherwise both machines will be identical and function identical except at the time the electrical current is given thru the probe. There is no alteration to the outside of either Stem Flex machines, the alteration to the sham machine will be internal, and will appear and sound identical to the Stim Flex machine which has not been altered.
323395|NCT01189110|B1|Baseline|Arm 1|Two separate Stim Flex machines will be used in this study: Machine A (usual care) will be a usual functioning machine which is FDA approved; Machine B (sham treatment) will be altered to disable the electrical current to flow to the probe. Otherwise both machines will be identical and function identical except at the time the electrical current is given thru the probe. There is no alteration to the outside of either Stem Flex machines, the alteration to the sham machine will be internal, and will appear and sound identical to the Stim Flex machine which has not been altered.
323396|NCT01189110|P2|Participant Flow|Arm 2|Placebo group- sham Stim Flex machine
323397|NCT01189110|P1|Participant Flow|Arm 1|Intervention- true Stim Flex treatment
323398|NCT01189110|O2|Outcome|Arm 2- Placebo|Receipt of sham auriculotherapy via a Stim Flex machine that disabled electrical flow of current to the ear probe.
323399|NCT01189110|O1|Outcome|Arm 1- Intervention|Receipt of auriculotherapy via a Stim Flex machine that provided full electrical flow of current to the ear probe.
323715|NCT01188538|O1|Outcome|Epiduo Gel|
323400|NCT01189110|E2|Reported Event|Arm 2- Placebo|Machine B (sham treatment) will be altered to disable the electrical current to flow to the probe. Otherwise both machines will be identical and function identical except at the time the electrical current is given thru the probe. There is no alteration to the outside of either Stem Flex machines, the alteration to the sham machine will be internal, and will appear and sound identical to the Stim Flex machine which has not been altered.
323401|NCT01189110|E1|Reported Event|Arm 1- Intervention|Two separate Stim Flex machines will be used in this study: Machine A (usual care) will be a usual functioning machine which is FDA approved; Machine B (sham treatment) will be altered to disable the electrical current to flow to the probe. Otherwise both machines will be identical and function identical except at the time the electrical current is given thru the probe. There is no alteration to the outside of either Stem Flex machines, the alteration to the sham machine will be internal, and will appear and sound identical to the Stim Flex machine which has not been altered.
323402|NCT01189071|B3|Baseline|Total|Total of all reporting groups
323403|NCT01189071|B2|Baseline|no Pill|The control group will have the standard of care which is no preoperative anticholinegic medication.
323404|NCT01189071|B1|Baseline|Darifenacin|"3 days of preoperative darifenacin anticholinergic medication~Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery."
323405|NCT01189071|P2|Participant Flow|no Pill|The control group will have the standard of care which is no preoperative anticholinegic medication.
323406|NCT01189071|P1|Participant Flow|Darifenacin|"3 days of preoperative darifenacin anticholinergic medication~Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery."
323407|NCT01189071|O2|Outcome|no Pill|The control group will have the standard of care which is no preoperative anticholinegic medication.
323408|NCT01189071|O1|Outcome|Darifenacin|"3 days of preoperative darifenacin anticholinergic medication~Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery."
323409|NCT01189071|O2|Outcome|no Pill|The control group will have the standard of care which is no preoperative anticholinegic medication.
323410|NCT01189071|O1|Outcome|Darifenacin|"3 days of preoperative darifenacin anticholinergic medication~Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery."
323411|NCT01189071|E2|Reported Event|no Pill|The control group will have the standard of care which is no preoperative anticholinegic medication.
323412|NCT01189071|E1|Reported Event|Darifenacin|"3 days of preoperative darifenacin anticholinergic medication~Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery."
323413|NCT01189032|B4|Baseline|Total|Total of all reporting groups
323414|NCT01189032|B3|Baseline|High Concentration|3% DE-089 ophthalmic solution
323415|NCT01189032|B2|Baseline|Low Concentration|1% DE-089 ophthalmic solution
323416|NCT01189032|B1|Baseline|Placebo|Placebo ophthalmic solution
323417|NCT01189032|P3|Participant Flow|High Concentration|3% DE-089 ophthalmic solution
323418|NCT01189032|P2|Participant Flow|Low Concentration|1% DE-089 ophthalmic solution
323419|NCT01189032|P1|Participant Flow|Placebo|Placebo ophthalmic solution
323420|NCT01189032|O3|Outcome|High Concentration|3% DE-089 ophthalmic solution
323421|NCT01189032|O2|Outcome|Low Concentration|1% DE-089 ophthalmic solution
323422|NCT01189032|O1|Outcome|Placebo|Placebo ophthalmic solution
323423|NCT01189032|E3|Reported Event|High Concentration|3% DE-089 ophthalmic solution
323424|NCT01189032|E2|Reported Event|Low Concentration|1% DE-089 ophthalmic solution
323425|NCT01189032|E1|Reported Event|Placebo|Placebo ophthalmic solution
323426|NCT01188967|B3|Baseline|Total|Total of all reporting groups
323427|NCT01188967|B2|Baseline|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects were randomized with a block size of 4. This group received the active treatment: GSK598809 pills,60 mg/day.
323428|NCT01188967|B1|Baseline|Placebo Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects were randomized with a block size of 4. This group received placebo pills.
323429|NCT01188967|P2|Participant Flow|Placebo Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received placebo pills.
323472|NCT01188876|O1|Outcome|Carboplatin/Pralatrexate|"carboplatin: Given intravenously on Day 1 of each 28-day cycle~pralatrexate: Given intravenously on Day 1 and Day 15 of each 28-day cycle."
323716|NCT01188538|E2|Reported Event|Benzoyl Peroxide (BPO) Gel|
323430|NCT01188967|P1|Participant Flow|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received 60 mg GSK598809 pills, the active treatment, for 6 weeks.
323431|NCT01188967|O2|Outcome|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received GSK598809 pills, the active treatment.
323432|NCT01188967|O1|Outcome|Placebo Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received placebo pills.
323433|NCT01188967|O2|Outcome|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received GSK598809 pills, the active treatment.
323434|NCT01188967|O1|Outcome|Placebo Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received placebo pills.
323435|NCT01188967|O2|Outcome|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received GSK598809 pills, the active treatment.
323436|NCT01188967|O1|Outcome|Placebo Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received placebo pills.
323437|NCT01188967|O2|Outcome|GSK598809 Treatment Group|
323438|NCT01188967|O1|Outcome|Placebo Treatment Group|
323439|NCT01188967|E2|Reported Event|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received the GSK598809 pills, the active treatment.
323440|NCT01188967|E1|Reported Event|Placebo Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received the placebo pills.
323441|NCT01188928|B5|Baseline|Total|Total of all reporting groups
323442|NCT01188928|B4|Baseline|Topical Suspension Vehicle|The topical suspension vehicle alone
323443|NCT01188928|B3|Baseline|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
323444|NCT01188928|B2|Baseline|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
323445|NCT01188928|B1|Baseline|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
323446|NCT01188928|P4|Participant Flow|Topical Suspension Vehicle|The topical suspension vehicle alone
323447|NCT01188928|P3|Participant Flow|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
323448|NCT01188928|P2|Participant Flow|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
323449|NCT01188928|P1|Participant Flow|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
323450|NCT01188928|O4|Outcome|Topical Suspension Vehicle|The topical suspension vehicle alone
323451|NCT01188928|O3|Outcome|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
323452|NCT01188928|O2|Outcome|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
323453|NCT01188928|O1|Outcome|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
323454|NCT01188928|O4|Outcome|Topical Suspension Vehicle|The topical suspension vehicle alone
323455|NCT01188928|O3|Outcome|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
323456|NCT01188928|O2|Outcome|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
323457|NCT01188928|O1|Outcome|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
323458|NCT01188928|O4|Outcome|Topical Suspension Vehicle|The topical suspension vehicle alone
323459|NCT01188928|O3|Outcome|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
323460|NCT01188928|O2|Outcome|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
323461|NCT01188928|O1|Outcome|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
323462|NCT01188928|O4|Outcome|Topical Suspension Vehicle|The topical suspension vehicle alone
323463|NCT01188928|O3|Outcome|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
323464|NCT01188928|O2|Outcome|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
323465|NCT01188928|O1|Outcome|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
323466|NCT01188928|E4|Reported Event|Topical Suspension Vehicle|The topical suspension vehicle alone
323467|NCT01188928|E3|Reported Event|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
323468|NCT01188928|E2|Reported Event|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
323469|NCT01188928|E1|Reported Event|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
323470|NCT01188876|B1|Baseline|Carboplatin/Pralatrexate|"carboplatin: Given intravenously on Day 1 of each 28-day cycle~pralatrexate: Given intravenously on Day 1 and Day 15 of each 28-day cycle."
323471|NCT01188876|P1|Participant Flow|Carboplatin/Pralatrexate|"carboplatin: Given intravenously on Day 1 of each 28-day cycle~pralatrexate: Given intravenously on Day 1 and Day 15 of each 28-day cycle."
323534|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
323473|NCT01188876|O1|Outcome|Carboplatin/Pralatrexate|"carboplatin: Given intravenously on Day 1 of each 28-day cycle~pralatrexate: Given intravenously on Day 1 and Day 15 of each 28-day cycle."
323474|NCT01188876|O1|Outcome|Carboplatin/Pralatrexate|"carboplatin: Given intravenously on Day 1 of each 28-day cycle~pralatrexate: Given intravenously on Day 1 and Day 15 of each 28-day cycle."
323475|NCT01188876|O1|Outcome|Carboplatin/Pralatrexate|"carboplatin: Given intravenously on Day 1 of each 28-day cycle~pralatrexate: Given intravenously on Day 1 and Day 15 of each 28-day cycle."
323476|NCT01188876|O1|Outcome|Carboplatin/Pralatrexate|"carboplatin: Given intravenously on Day 1 of each 28-day cycle~pralatrexate: Given intravenously on Day 1 and Day 15 of each 28-day cycle."
323477|NCT01188876|O1|Outcome|Carboplatin/Pralatrexate|"carboplatin: Given intravenously on Day 1 of each 28-day cycle~pralatrexate: Given intravenously on Day 1 and Day 15 of each 28-day cycle."
323478|NCT01188876|O1|Outcome|Carboplatin/Pralatrexate|"carboplatin: Given intravenously on Day 1 of each 28-day cycle~pralatrexate: Given intravenously on Day 1 and Day 15 of each 28-day cycle."
323479|NCT01188876|E1|Reported Event|Carboplatin/Pralatrexate|"carboplatin: Given intravenously on Day 1 of each 28-day cycle~pralatrexate: Given intravenously on Day 1 and Day 15 of each 28-day cycle."
323480|NCT01188811|B3|Baseline|Total|Total of all reporting groups
323481|NCT01188811|B2|Baseline|Placebo|"28 subjects receive placebo daily~Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
323482|NCT01188811|B1|Baseline|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily~lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
323483|NCT01188811|P2|Participant Flow|Placebo|"28 subjects receive placebo daily~Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
323484|NCT01188811|P1|Participant Flow|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily~lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
323485|NCT01188811|O2|Outcome|Placebo|"28 subjects receive placebo daily~Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
323486|NCT01188811|O1|Outcome|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily~lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
323487|NCT01188811|O2|Outcome|Placebo|"28 subjects receive placebo daily~Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
323488|NCT01188811|O1|Outcome|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily~lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
323489|NCT01188811|O2|Outcome|Placebo|"28 subjects receive placebo daily~Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
323490|NCT01188811|O1|Outcome|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily~lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
323491|NCT01188811|E2|Reported Event|Placebo|"28 subjects receive placebo daily~Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
323492|NCT01188811|E1|Reported Event|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily~lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
323493|NCT01188798|B3|Baseline|Total|Total of all reporting groups
323494|NCT01188798|B2|Baseline|Pentostatin|"Participants will be biologically stratified according to disease, donor, and KIR match between donor and host. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Pentostatin: Participants were randomized to receive pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
323495|NCT01188798|B1|Baseline|Methotrexate|"Participants will be biologically stratified according to disease, donor, and KIR match. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Methotrexate: Participants were randomized to receive methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
323496|NCT01188798|P2|Participant Flow|Pentostatin|"Participants will be biologically stratified according to disease, donor, and KIR match between donor and host. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Participants were randomized to receive pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
323497|NCT01188798|P1|Participant Flow|Methotrexate|"Participants will be biologically stratified according to disease, donor, and KIR match. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Participants were randomized to receive methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
323498|NCT01188798|O2|Outcome|Pentostatin|"Participants will be biologically stratified according to disease, donor, and KIR match between donor and host. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin).~Pentostatin: Participants were randomized to receive pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
323535|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323536|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323499|NCT01188798|O1|Outcome|Methotrexate|"Participants will be biologically stratified according to disease, donor, and KIR match. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Merthotrexate: Participants were randomized to receive methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
323500|NCT01188798|O2|Outcome|Pentostatin|"Participants will be biologically stratified according to disease, donor, and KIR match between donor and host. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Pentostatin: Participants were randomized to receive pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
323501|NCT01188798|O1|Outcome|Methotrexate|"Participants will be biologically stratified according to disease, donor, and KIR match. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Merthotrexate: Participants were randomized to receive methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
323502|NCT01188798|E2|Reported Event|Pentostatin|"Participants will be biologically stratified according to disease, donor, and KIR match between donor and host. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Pentostatin: Participants were randomized to receive pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
323503|NCT01188798|E1|Reported Event|Methotrexate|"Participants will be biologically stratified according to disease, donor, and KIR match. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Merthotrexate: Participants were randomized to receive methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
323504|NCT01188772|B5|Baseline|Total|Total of all reporting groups
323505|NCT01188772|B4|Baseline|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
323506|NCT01188772|B3|Baseline|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323507|NCT01188772|B2|Baseline|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323508|NCT01188772|B1|Baseline|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323509|NCT01188772|P4|Participant Flow|Sofosbuvir 400 mg (Genotype 2/3)|Participants with genotype 2 or 3 HCV infection received sofosbuvir 400 mg (4 x 100 mg tablets)+PEG+RBV for 12 weeks.
323510|NCT01188772|P3|Participant Flow|Placebo (Genotype 1)|Participants with genotype 1 HCV infection were randomized to receive placebo to match sofosbuvir (4 tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks.
323511|NCT01188772|P2|Participant Flow|Sofosbuvir 400 mg (Genotype 1)|Participants with genotype 1 HCV infection were randomized to receive sofosbuvir 400 mg (4 x 100 mg tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks.
323512|NCT01188772|P1|Participant Flow|Sofosbuvir 200 mg (Genotype 1)|Participants with genotype 1 HCV infection were randomized to receive sofosbuvir 200 mg (2 x 100 mg tablets)+placebo to match sofosbuvir (2 tablets)+pegylated interferon alfa-2a (PEG)+ribavirin (RBV) for 12 weeks followed by PEG+RBV for up to an additional 36 weeks.
323513|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
323514|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
323515|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
323516|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
323517|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
323518|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
323519|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
323520|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
323521|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
323522|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
323523|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
323524|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
323525|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
323526|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
323527|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
323528|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
323529|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
323530|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
323531|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
323532|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
323533|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
323717|NCT01188538|E1|Reported Event|Epiduo Gel|
323539|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323540|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323541|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323542|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
323543|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323544|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323545|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323546|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
323547|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323548|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323549|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323550|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
323551|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323552|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323553|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323554|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
323555|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323556|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323557|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323558|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
323559|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323560|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323561|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323562|NCT01188772|E4|Reported Event|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
323563|NCT01188772|E3|Reported Event|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323564|NCT01188772|E2|Reported Event|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323565|NCT01188772|E1|Reported Event|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
323566|NCT01188694|B4|Baseline|Total|Total of all reporting groups
323567|NCT01188694|B3|Baseline|Delayed Psychotherapy|Delayed Psychotherapy: Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).
323568|NCT01188694|B2|Baseline|Psychotherapy Plus Placebo|Psychotherapy plus Placebo: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given.
323569|NCT01188694|B1|Baseline|Psychotherapy Plus Methylene Blue, USP|Psychotherapy plus Methylene Blue, USP: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given.
323570|NCT01188694|P3|Participant Flow|Delayed Psychotherapy|Delayed Psychotherapy: Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).
323571|NCT01188694|P2|Participant Flow|Psychotherapy Plus Placebo|Psychotherapy plus Placebo: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given.
323572|NCT01188694|P1|Participant Flow|Psychotherapy Plus Methylene Blue, USP|Psychotherapy plus Methylene Blue, USP: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given.
323573|NCT01188694|O3|Outcome|Delayed Psychotherapy|Delayed Psychotherapy: Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).
323574|NCT01188694|O2|Outcome|Psychotherapy Plus Placebo|Psychotherapy plus Placebo: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given.
323575|NCT01188694|O1|Outcome|Psychotherapy Plus Methylene Blue, USP|Psychotherapy plus Methylene Blue, USP: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given.
323576|NCT01188694|E3|Reported Event|Delayed Psychotherapy|Delayed Psychotherapy: Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).
323577|NCT01188694|E2|Reported Event|Psychotherapy Plus Placebo|Psychotherapy plus Placebo: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given.
323578|NCT01188694|E1|Reported Event|Psychotherapy Plus Methylene Blue, USP|Psychotherapy plus Methylene Blue, USP: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given.
323579|NCT01188681|B5|Baseline|Total|Total of all reporting groups
323580|NCT01188681|B4|Baseline|Phase 2: Bendamustine|"Bendamustine alone (70 mg/m2)~Bendamustine: 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
323581|NCT01188681|B3|Baseline|Phase 2: TRU-016 and Bendamustine|"TRU-016 (20 mg/kg) and bendamustine (70 mg/m2)~TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
323582|NCT01188681|B2|Baseline|Phase 1: 20 mg/kg TRU-016|"TRU-016 (20 mg/kg) and bendamustine (70 mg/m2)~TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
323583|NCT01188681|B1|Baseline|Phase 1: 15 mg/kg TRU-016|"TRU-016 (15 mg/kg) and bendamustine (70 mg/m2)~TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
323584|NCT01188681|P4|Participant Flow|Phase 2 Bendamustine|Patients in the bendamustine arm received bendamustine (70 mg/m2) administered IV on Days 1 and 2 of each cycle for up to six 28-day cycles.
323585|NCT01188681|P3|Participant Flow|Phase 2 TRU-016 and Bendamustine|Patients in the combination arm received otlertuzumab (20 mg/kg) weekly by IV infusion for two 28-day cycles then every 14 days for four 28-day cycles. In both arms, bendamustine (70 mg/m2) was administered IV on Days 1 and 2 of each cycle for up to six 28-day cycles.
323586|NCT01188681|P2|Participant Flow|Phase 1 20 mg/kg|TRU-016 (20 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles and bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
323587|NCT01188681|P1|Participant Flow|Phase 1 15 mg/kg|TRU-016 (15 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles and bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
323588|NCT01188681|O4|Outcome|Phase 1: 20 mg/kg TRU-016 +Bendamustine|TRU-016 and bendamustine: TRU-016 (n = 6 patients), 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
323589|NCT01188681|O3|Outcome|Phase 1: 15 mg/kg TRU-016 +Beendamustine|TRU-016 and bendamustine: TRU-016 (n = 6 patients), 15 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
323590|NCT01188681|O2|Outcome|Phase 2: Bendamustine|"Bendamustine alone (n = 33 patients) (70 mg/m2)~Bendamustine: 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
323591|NCT01188681|O1|Outcome|Phase 2: TRU-016 and Bendamustine|"TRU-016 (n = 32 patients), 20 mg/kg and bendamustine (70 mg/m2)~TRU-016 and bendamustine: TRU-016 (n = 33 patients), 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
323592|NCT01188681|O4|Outcome|Bendamustine|"Bendamustine alone (n = 33 patients) (70 mg/m2)~Bendamustine: 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
323593|NCT01188681|O3|Outcome|TRU-016 and Bendamustine|"TRU-016 (n = 32 patients), 20 mg/kg and bendamustine (70 mg/m2)~TRU-016 and bendamustine: TRU-016 (n = 33 patients), 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
323594|NCT01188681|O2|Outcome|Phase 1 20 mg/kg TRU-016|20 mg/kg TRU-016 + 70 mg/m2 bendamustine (n=6) dose group
323595|NCT01188681|O1|Outcome|Phase 1 15 mg/kg TRU-016|15 mg/kg TRU-016 + 70 mg/m2 bendamustine (n=6) dose group
323596|NCT01188681|E4|Reported Event|Phase 2:Bendamustine|"Bendamustine alone (70 mg/m2)~Bendamustine: 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
323597|NCT01188681|E3|Reported Event|Phase 2: TRU-016 and Bendamustine|"TRU-016 (20 mg/kg) and bendamustine (70 mg/m2)~TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
323598|NCT01188681|E2|Reported Event|Phase 1: 20 mg/kg|TRU-016 (20 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
323599|NCT01188681|E1|Reported Event|Phase 1: 15 mg/kg|TRU-016 (15 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
323600|NCT01188668|B1|Baseline|Aripiprazole 5 mg, Aripiprazole 5 mg + DVS SR 100 mg|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1. DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323601|NCT01188668|P1|Participant Flow|Aripiprazole 5 mg, Aripiprazole 5 mg + DVS SR 100 mg|Aripiprazole (ARIP) as a single oral dose of 5 milligrams (mg) Period 1 / Day 1. Desvenlafaxine sustained release (DVS SR) as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323602|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323603|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
323604|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323605|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
323606|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323608|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323609|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
323610|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323611|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
323612|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323613|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
323614|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323615|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
323616|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323617|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
323618|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323619|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
323620|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323621|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
323622|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323623|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
323624|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323625|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
323626|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323627|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
323628|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323629|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
323630|NCT01188668|E3|Reported Event|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 7 though Day 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
323631|NCT01188668|E2|Reported Event|DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state).
323632|NCT01188668|E1|Reported Event|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
323633|NCT01188655|B1|Baseline|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
323634|NCT01188655|P1|Participant Flow|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
323635|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
323636|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
323637|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
323718|NCT01188499|B6|Baseline|Total|Total of all reporting groups
323638|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
323639|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
323640|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
323641|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
323642|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
323643|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
323644|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
323645|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
323646|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
323647|NCT01188655|E1|Reported Event|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
323648|NCT01188603|B1|Baseline|Flibanserin|100mg Flibanserin administered orally once daily
323649|NCT01188603|P1|Participant Flow|Flibanserin|100mg Flibanserin administered orally once daily
323650|NCT01188603|O1|Outcome|Flibanserin|100mg Flibanserin administered orally once daily
323651|NCT01188603|O1|Outcome|Flibanserin|100mg Flibanserin administered orally once daily
323652|NCT01188603|O1|Outcome|Flibanserin|100mg Flibanserin administered orally once daily
323653|NCT01188603|O1|Outcome|Flibanserin|100mg Flibanserin administered orally once daily
323654|NCT01188603|O1|Outcome|Flibanserin|100mg Flibanserin administered orally once daily
323655|NCT01188603|E1|Reported Event|Flibanserin|100mg Flibanserin administered orally once daily
323656|NCT01188577|B3|Baseline|Total|Total of all reporting groups
323657|NCT01188577|B2|Baseline|T, C|Subjects received one of the two treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T: Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
323658|NCT01188577|B1|Baseline|C, T|Subjects received one of the two treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T: Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
323659|NCT01188577|P2|Participant Flow|T, C|Subjects received one of the two treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T: Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
323660|NCT01188577|P1|Participant Flow|C, T|Subjects received one of the two treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T: Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
323661|NCT01188577|O2|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
323662|NCT01188577|O1|Outcome|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
323663|NCT01188577|O2|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
323664|NCT01188577|O1|Outcome|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
323665|NCT01188577|O2|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
323666|NCT01188577|O1|Outcome|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
323667|NCT01188577|O2|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
323668|NCT01188577|O1|Outcome|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
323669|NCT01188577|O2|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
323670|NCT01188577|O1|Outcome|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
323671|NCT01188577|O2|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
323672|NCT01188577|O1|Outcome|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
323673|NCT01188577|E2|Reported Event|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
323674|NCT01188577|E1|Reported Event|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
323675|NCT01188564|B3|Baseline|Total|Total of all reporting groups
323676|NCT01188564|B2|Baseline|Placebo (Saline)|Placebo (Saline): One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment
323677|NCT01188564|B1|Baseline|rhC1INH|rhC1INH: One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.
323678|NCT01188564|P2|Participant Flow|Placebo (Saline)|Placebo (Saline): One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment
323679|NCT01188564|P1|Participant Flow|rhC1INH|rhC1INH: One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.
323680|NCT01188564|O2|Outcome|Placebo (Saline)|Placebo (Saline): One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment
323681|NCT01188564|O1|Outcome|rhC1INH|rhC1INH: One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.
323682|NCT01188564|O2|Outcome|Placebo (Saline)|Placebo (Saline): One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment
323683|NCT01188564|O1|Outcome|rhC1INH|rhC1INH: One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.
323684|NCT01188564|E2|Reported Event|Placebo (Saline)|Placebo (Saline): One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment
323685|NCT01188564|E1|Reported Event|rhC1INH|rhC1INH: One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.
323686|NCT01188551|B5|Baseline|Total|Total of all reporting groups
323687|NCT01188551|B4|Baseline|Fentanyl w/o Midazolam|Fentanyl given intranasally in the OR without any pre-medication.
323688|NCT01188551|B3|Baseline|Dexmedetomidine w/o Midazolam|Dexmedetomidine given intranasally in OR without any pre-medication.
323689|NCT01188551|B2|Baseline|Fentanyl w/ Midazolam|Midazolam given orally pre-op and fentanyl given intranasally in OR.
323690|NCT01188551|B1|Baseline|Dexmedetomidine w/ Midazolam|Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
323691|NCT01188551|P4|Participant Flow|Fentanyl w/o Midazolam|Fentanyl given intranasally in the OR without any pre-medication.
323692|NCT01188551|P3|Participant Flow|Dexmedetomidine w/o Midazolam|Dexmedetomidine given intranasally in OR without any pre-medication.
323693|NCT01188551|P2|Participant Flow|Fentanyl w/ Midazolam|Midazolam given orally pre-op and fentanyl given intranasally in OR.
323694|NCT01188551|P1|Participant Flow|Dexmedetomidine w/ Midazolam|Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
323695|NCT01188551|O4|Outcome|Fentanyl w/o Midazolam|Fentanyl given intranasally in the OR without any pre-medication.
323696|NCT01188551|O3|Outcome|Dexmedetomidine w/o Midazolam|Dexmedetomidine given intranasally in OR without any pre-medication.
323697|NCT01188551|O2|Outcome|Fentanyl w/ Midazolam|Midazolam given orally pre-op and fentanyl given intranasally in OR.
323698|NCT01188551|O1|Outcome|Dexmedetomidine w/ Midazolam|Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
323699|NCT01188551|O4|Outcome|Fentanyl w/o Midazolam|Fentanyl given intranasally in the OR without any pre-medication.
323700|NCT01188551|O3|Outcome|Dexmedetomidine w/o Midazolam|Dexmedetomidine given intranasally in OR without any pre-medication.
323701|NCT01188551|O2|Outcome|Fentanyl w/ Midazolam|Midazolam given orally pre-op and fentanyl given intranasally in OR.
323702|NCT01188551|O1|Outcome|Dexmedetomidine w/ Midazolam|Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
323703|NCT01188551|E4|Reported Event|Fentanyl w/o Midazolam|Fentanyl given intranasally in the OR without any pre-medication.
323704|NCT01188551|E3|Reported Event|Dexmedetomidine w/o Midazolam|Dexmedetomidine given intranasally in OR without any pre-medication.
323705|NCT01188551|E2|Reported Event|Fentanyl w/ Midazolam|Midazolam given orally pre-op and fentanyl given intranasally in OR.
323706|NCT01188551|E1|Reported Event|Dexmedetomidine w/ Midazolam|Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
323707|NCT01188538|B3|Baseline|Total|Total of all reporting groups
323708|NCT01188538|B2|Baseline|Benzoyl Peroxide (BPO) Gel|
323709|NCT01188538|B1|Baseline|Epiduo Gel|
323710|NCT01188538|P2|Participant Flow|Benzoyl Peroxide (BPO) Gel|
323711|NCT01188538|P1|Participant Flow|Epiduo Gel|
323712|NCT01188538|O2|Outcome|BPO Gel|BPO Gel Topical to the face, once daily application in the evening
323713|NCT01188538|O1|Outcome|Epiduo® Gel|Epiduo® Gel Topical to the face, once daily application in the evening
323714|NCT01188538|O2|Outcome|Benzoyl Peroxide (BPO) Gel|
323719|NCT01188499|B5|Baseline|Arm 5: Liposomal Doxorubicin + Birinapant|"Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
323720|NCT01188499|B4|Baseline|Arm 4: Gemcitabine + Birinapant|"Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
323721|NCT01188499|B3|Baseline|Arm 3: Docetaxel + Birinapant|"Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
323722|NCT01188499|B2|Baseline|Arm 2: Irinotecan + Birinapant|"Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
323723|NCT01188499|B1|Baseline|Arm 1: Carboplatin/Paclitaxel + Birinapant|"Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
323724|NCT01188499|P5|Participant Flow|Arm 5: Liposomal Doxorubicin + Birinapant|"Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
323725|NCT01188499|P4|Participant Flow|Arm 4: Gemcitabine + Birinapant|"Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
323726|NCT01188499|P3|Participant Flow|Arm 3: Docetaxel + Birinapant|"Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
323727|NCT01188499|P2|Participant Flow|Arm 2: Irinotecan + Birinapant|"Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
323728|NCT01188499|P1|Participant Flow|Arm 1: Carboplatin/Paclitaxel + Birinapant|"Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
323729|NCT01188499|O5|Outcome|Arm 5: Liposomal Doxorubicin|"Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
323730|NCT01188499|O4|Outcome|Arm 4: Gemcitabine + TL32711|"Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
323731|NCT01188499|O3|Outcome|Arm 3: Docetaxel + TL32711|"Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
323732|NCT01188499|O2|Outcome|Arm 2: Irinotecan + TL32711|"Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
323733|NCT01188499|O1|Outcome|Arm 1: Carboplatin/Paclitaxel + TL32711|"Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
323734|NCT01188499|O5|Outcome|Arm 5: Liposomal Doxorubicin|"Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
323797|NCT01188343|B1|Baseline|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
323735|NCT01188499|O4|Outcome|Arm 4: Gemcitabine + TL32711|"Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
323736|NCT01188499|O3|Outcome|Arm 3: Docetaxel + TL32711|"Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
323737|NCT01188499|O2|Outcome|Arm 2: Irinotecan + TL32711|"Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
323738|NCT01188499|O1|Outcome|Arm 1: Carboplatin/Paclitaxel + TL32711|"Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
323739|NCT01188499|E5|Reported Event|Arm 5: Liposomal Doxorubicin + Birinapant|"Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
323740|NCT01188499|E4|Reported Event|Arm 4: Gemcitabine + Birinapant|"Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
323741|NCT01188499|E3|Reported Event|Arm 3: Docetaxel + Birinapant|"Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
323742|NCT01188499|E2|Reported Event|Arm 2: Irinotecan + Birinapant|"Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
323743|NCT01188499|E1|Reported Event|Arm 1: Carboplatin/Paclitaxel + Birinapant|"Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
323744|NCT01188460|B3|Baseline|Total|Total of all reporting groups
323745|NCT01188460|B2|Baseline|Experimental Group|"Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints~Self-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323746|NCT01188460|B1|Baseline|Control Group|"Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints~Sleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323747|NCT01188460|P2|Participant Flow|Experimental Group|"Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints~Self-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323748|NCT01188460|P1|Participant Flow|Control Group|"Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints~Sleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323749|NCT01188460|O2|Outcome|Experimental Group|"Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints~Self-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323750|NCT01188460|O1|Outcome|Control Group|"Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints~Sleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323751|NCT01188460|O2|Outcome|Experimental Group|"Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints~Self-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323798|NCT01188343|P3|Participant Flow|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE CV vaccine on day 0
324220|NCT01187355|P2|Participant Flow|Renu Fresh MPS|Multi-purpose contact lens solution
323752|NCT01188460|O1|Outcome|Control Group|"Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints~Sleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323753|NCT01188460|O2|Outcome|Experimental Group|"Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints~Self-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323754|NCT01188460|O1|Outcome|Control Group|"Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints~Sleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323755|NCT01188460|O2|Outcome|Experimental Group|"Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints~Self-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323756|NCT01188460|O1|Outcome|Control Group|"Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints~Sleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323757|NCT01188460|O2|Outcome|Experimental Group|"Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints~Self-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323758|NCT01188460|O1|Outcome|Control Group|"Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints~Sleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323759|NCT01188460|O2|Outcome|Experimental Group|"Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints~Self-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323760|NCT01188460|O1|Outcome|Control Group|"Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints~Sleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323761|NCT01188460|O2|Outcome|Experimental Group|"Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints~Self-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323762|NCT01188460|O1|Outcome|Control Group|"Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints~Sleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323763|NCT01188460|O2|Outcome|Experimental Group|"Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints~Self-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323764|NCT01188460|O1|Outcome|Control Group|"Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints~Sleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323765|NCT01188460|O2|Outcome|Experimental Group|"Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints~Self-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323766|NCT01188460|O1|Outcome|Control Group|"Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints~Sleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323767|NCT01188460|O2|Outcome|Experimental Group|"Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints~Self-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323768|NCT01188460|O1|Outcome|Control Group|"Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints~Sleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323799|NCT01188343|P2|Participant Flow|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
323843|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
323769|NCT01188460|O2|Outcome|Experimental Group|"Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints~Self-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323770|NCT01188460|O1|Outcome|Control Group|"Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints~Sleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323771|NCT01188460|E2|Reported Event|Experimental Group|"Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints~Self-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323772|NCT01188460|E1|Reported Event|Control Group|"Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints~Sleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality"
323773|NCT01188447|B1|Baseline|Eligible Low-risk Trauma Patients|"Paramedics will use the Canadian C-Spine Rule to evaluate low-risk trauma patients meeting the study inclusion criteria in order to determine the need for spinal immobilization for transport to the hospital.~Canadian C-Spine Rule: Paramedics will apply a validated decision rule (the Canadian C-spine Rule) to determine whether or not immobilization is required for trauma patients being transported to the emergency department."
323774|NCT01188447|P1|Participant Flow|Eligible Low-risk Trauma Patients|"Paramedics will use the Canadian C-Spine Rule to evaluate low-risk trauma patients meeting the study inclusion criteria in order to determine the need for spinal immobilization for transport to the hospital.~Canadian C-Spine Rule: Paramedics will apply a validated decision rule (the Canadian C-spine Rule) to determine whether or not immobilization is required for trauma patients being transported to the emergency department."
323775|NCT01188447|O1|Outcome|Eligible Low-risk Trauma Patients|"Paramedics will use the Canadian C-Spine Rule to evaluate low-risk trauma patients meeting the study inclusion criteria in order to determine the need for spinal immobilization for transport to the hospital.~Canadian C-Spine Rule: Paramedics will apply a validated decision rule (the Canadian C-spine Rule) to determine whether or not immobilization is required for trauma patients being transported to the emergency department."
323776|NCT01188447|O1|Outcome|Eligible Low-risk Trauma Patients|"Paramedics will use the Canadian C-Spine Rule to evaluate low-risk trauma patients meeting the study inclusion criteria in order to determine the need for spinal immobilization for transport to the hospital.~Canadian C-Spine Rule: Paramedics will apply a validated decision rule (the Canadian C-spine Rule) to determine whether or not immobilization is required for trauma patients being transported to the emergency department."
323777|NCT01188447|O1|Outcome|Eligible Low-risk Trauma Patients|"Paramedics will use the Canadian C-Spine Rule to evaluate low-risk trauma patients meeting the study inclusion criteria in order to determine the need for spinal immobilization for transport to the hospital.~Canadian C-Spine Rule: Paramedics will apply a validated decision rule (the Canadian C-spine Rule) to determine whether or not immobilization is required for trauma patients being transported to the emergency department."
323778|NCT01188447|O1|Outcome|Eligible Patients|eligible patients evaluated with the Canadian C-Spine Rule
323779|NCT01188447|O1|Outcome|Eligible Low-risk Trauma Patients|"Paramedics will use the Canadian C-Spine Rule to evaluate low-risk trauma patients meeting the study inclusion criteria in order to determine the need for spinal immobilization for transport to the hospital.~Canadian C-Spine Rule: Paramedics will apply a validated decision rule (the Canadian C-spine Rule) to determine whether or not immobilization is required for trauma patients being transported to the emergency department."
323780|NCT01188447|E1|Reported Event|Eligible Low-risk Trauma Patients|"Paramedics will use the Canadian C-Spine Rule to evaluate low-risk trauma patients meeting the study inclusion criteria in order to determine the need for spinal immobilization for transport to the hospital.~Canadian C-Spine Rule: Paramedics will apply a validated decision rule (the Canadian C-spine Rule) to determine whether or not immobilization is required for trauma patients being transported to the emergency department."
323781|NCT01188421|B4|Baseline|Total|Total of all reporting groups
323782|NCT01188421|B3|Baseline|Clonidine|"Oral clonidine tablets (or placebo)~Clonidine: up to 0.8 mg per day (oral)"
323783|NCT01188421|B2|Baseline|Tramadol ER|"Oral tramadol tablets (or placebo)~Tramadol ER: up to 600 mg per day"
323784|NCT01188421|B1|Baseline|Buprenorphine|"Sublingual buprenorphine/naloxone tablets (or placebo)~Buprenorphine/naloxone: up to 8/2 mg SL per day"
323785|NCT01188421|P3|Participant Flow|Clonidine|"Oral clonidine tablets (or placebo)~Clonidine: up to 0.8 mg per day (oral)"
323786|NCT01188421|P2|Participant Flow|Tramadol ER|"Oral tramadol tablets (or placebo)~Tramadol ER: up to 600 mg per day"
323787|NCT01188421|P1|Participant Flow|Buprenorphine|"Sublingual buprenorphine/naloxone tablets (or placebo)~Buprenorphine/naloxone: up to 8/2 mg SL per day"
323788|NCT01188421|O3|Outcome|Clonidine|"Oral clonidine tablets (or placebo)~Clonidine: up to 0.8 mg per day (oral)"
323789|NCT01188421|O2|Outcome|Tramadol ER|"Oral tramadol tablets (or placebo)~Tramadol ER: up to 600 mg per day"
323790|NCT01188421|O1|Outcome|Buprenorphine|"Sublingual buprenorphine/naloxone tablets (or placebo)~Buprenorphine/naloxone: up to 8/2 mg SL per day"
323791|NCT01188421|E3|Reported Event|Clonidine|"Oral clonidine tablets (or placebo)~Clonidine: up to 0.8 mg per day (oral)"
323792|NCT01188421|E2|Reported Event|Tramadol ER|"Oral tramadol tablets (or placebo)~Tramadol ER: up to 600 mg per day"
323793|NCT01188421|E1|Reported Event|Buprenorphine|"Sublingual buprenorphine/naloxone tablets (or placebo)~Buprenorphine/naloxone: up to 8/2 mg SL per day"
323794|NCT01188343|B4|Baseline|Total|Total of all reporting groups
323795|NCT01188343|B3|Baseline|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
323796|NCT01188343|B2|Baseline|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
323800|NCT01188343|P1|Participant Flow|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
323801|NCT01188343|O3|Outcome|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
323802|NCT01188343|O2|Outcome|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
323803|NCT01188343|O1|Outcome|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
323804|NCT01188343|O3|Outcome|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
323805|NCT01188343|O2|Outcome|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
323806|NCT01188343|O1|Outcome|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
323807|NCT01188343|O3|Outcome|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
323808|NCT01188343|O2|Outcome|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
323809|NCT01188343|O1|Outcome|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
323810|NCT01188343|O3|Outcome|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
323811|NCT01188343|O2|Outcome|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
323812|NCT01188343|O1|Outcome|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
323813|NCT01188343|O3|Outcome|JE-CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
323814|NCT01188343|O2|Outcome|MMR + JE-CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE-CV vaccine on day 42
323815|NCT01188343|O1|Outcome|JE-CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
323816|NCT01188343|O3|Outcome|JE-CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
323817|NCT01188343|O2|Outcome|MMR + JE-CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE-CV vaccine on day 42
323818|NCT01188343|O1|Outcome|JE-CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
323819|NCT01188343|O3|Outcome|JE-CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
323820|NCT01188343|O2|Outcome|MMR + JE-CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE-CV vaccine on day 42
323821|NCT01188343|O1|Outcome|JE-CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
323822|NCT01188343|E3|Reported Event|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
323823|NCT01188343|E2|Reported Event|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
323824|NCT01188343|E1|Reported Event|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
323825|NCT01188226|B1|Baseline|Nano Hybrid Composite Denture Teeth|Denture teeth are made of nano hybrid composite material
323826|NCT01188226|P1|Participant Flow|Nano Hybrid Composite Denture Teeth|"Denture teeth are made of nano hybrid composite material~Denture teeth: Denture teeth made of nano hybrid composite material"
323827|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
323828|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
323829|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
323830|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
323831|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
323832|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
323833|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
323834|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
323835|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
323836|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
323837|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
323838|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
323839|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
323840|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
323841|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
323842|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
323844|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
323845|NCT01188226|O1|Outcome|Nano Hybrid Composite Denture Teeth|Denture teeth are made of nano hybrid composite material
323846|NCT01188226|O1|Outcome|Nano Hybrid Composite Denture Teeth|"Denture teeth are made of nano hybrid composite material~Denture teeth: Denture teeth made of nano hybrid composite material"
323847|NCT01188226|O1|Outcome|Nano Hybrid Composite Denture Teeth|Denture teeth are made of nano hybrid composite material
323848|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
323849|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
323850|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
323851|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
323852|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
323853|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
323854|NCT01188226|O1|Outcome|Participants With Nano Hybrid Composite Dentures|Denture teeth are made of nano hybrid composite material
323855|NCT01188226|O2|Outcome|Lower Denture|Participants wearing lower denture 24 months after denture completion. Denture teeth are made of nano hybrid composite material.
323856|NCT01188226|O1|Outcome|Upper Denture|Participants wearing upper denture 24 months after denture completion. Denture teeth are made of nano hybrid composite material.
323857|NCT01188226|O2|Outcome|Lower Denture|Participants with lower denture in use 18 months after denture completion. Denture teeth are made of nano hybrid composite material
323858|NCT01188226|O1|Outcome|Upper Denture|Denture teeth are made of nano hybrid composite material
323859|NCT01188226|O2|Outcome|Lower Denture|Denture teeth are made of nano hybrid composite material
323860|NCT01188226|O1|Outcome|Upper Denture|Denture teeth are made of nano hybrid composite material
323861|NCT01188226|O2|Outcome|Lower Denture|Denture teeth are made of nano hybrid composite material
323862|NCT01188226|O1|Outcome|Upper Denture|Denture teeth are made of nano hybrid composite material
323863|NCT01188226|E1|Reported Event|Nano Hybrid Composite Denture Teeth|Denture teeth are made of nano hybrid composite material
323864|NCT01188109|B1|Baseline|Gemcitabine / Cisplatin|"Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.~Gemcitabine: Standard of care chemotherapy and dosage~Dose - 1000 mg/m²~Schedule - Days 1 and 15; Q 28 days~Cisplatin: Dose - 50 mg/m²~Schedule - Days 1 and 15; Q 28 days"
323865|NCT01188109|P1|Participant Flow|Gemcitabine / Cisplatin|"Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.~Gemcitabine: Standard of care chemotherapy and dosage~Dose - 1000 mg/m²~Schedule - Days 1 and 15; Q 28 days~Cisplatin: Dose - 50 mg/m²~Schedule - Days 1 and 15; Q 28 days"
323866|NCT01188109|O1|Outcome|Gemcitabine / Cisplatin|"Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.~Gemcitabine: Standard of care chemotherapy and dosage~Dose - 1000 mg/m²~Schedule - Days 1 and 15; Q 28 days~Cisplatin: Dose - 50 mg/m²~Schedule - Days 1 and 15; Q 28 days"
323867|NCT01188109|O1|Outcome|Gemcitabine / Cisplatin|"Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.~Gemcitabine: Standard of care chemotherapy and dosage~Dose - 1000 mg/m²~Schedule - Days 1 and 15; Q 28 days~Cisplatin: Dose - 50 mg/m²~Schedule - Days 1 and 15; Q 28 days"
323868|NCT01188109|E1|Reported Event|Gemcitabine / Cisplatin|"Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.~Gemcitabine: Standard of care chemotherapy and dosage~Dose - 1000 mg/m²~Schedule - Days 1 and 15; Q 28 days~Cisplatin: Dose - 50 mg/m²~Schedule - Days 1 and 15; Q 28 days"
323869|NCT01187953|B3|Baseline|Total|Total of all reporting groups
323870|NCT01187953|B2|Baseline|Prograf (Tacrolimus)|"Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.~Prograf (tacrolimus): Administered per current product labeling"
323871|NCT01187953|B1|Baseline|LCP-Tacro|"The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.~LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels."
323872|NCT01187953|P2|Participant Flow|Prograf (Tacrolimus)|"Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.~Prograf (tacrolimus): Administered per current product labeling"
323873|NCT01187953|P1|Participant Flow|LCP-Tacro|"The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.~LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels."
323874|NCT01187953|O2|Outcome|Prograf (Tacrolimus)|"Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.~Prograf (tacrolimus): Administered per current product labeling"
323922|NCT01187771|O2|Outcome|Continuous Positive Airway Pressure|
323875|NCT01187953|O1|Outcome|LCP-Tacro|"The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.~LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels."
323876|NCT01187953|O2|Outcome|Prograf (Tacrolimus)|"Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.~Prograf (tacrolimus): Administered per current product labeling"
323877|NCT01187953|O1|Outcome|LCP-Tacro|"The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.~LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels."
323878|NCT01187953|E2|Reported Event|Prograf (Tacrolimus)|"Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.~Prograf (tacrolimus): Administered per current product labeling"
323879|NCT01187953|E1|Reported Event|LCP-Tacro|"The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.~LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels."
323880|NCT01187914|B1|Baseline|Open Irrigation|Those individuals who had an ablation using open irrigation cooled-tip RF ablation.
323881|NCT01187914|P1|Participant Flow|Open Irrigation|Those individuals who had an ablation using open irrigation cooled-tip RF ablation.
323882|NCT01187914|O1|Outcome|Open Irrigation|Those individuals who had an ablation using open irrigation cooled-tip RF ablation.
323883|NCT01187914|E1|Reported Event|Open Irrigation|Those individuals who had an ablation using open irrigation cooled-tip RF ablation.
323884|NCT01187901|B3|Baseline|Total|Total of all reporting groups
323885|NCT01187901|B2|Baseline|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
323886|NCT01187901|B1|Baseline|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
323887|NCT01187901|P2|Participant Flow|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
323888|NCT01187901|P1|Participant Flow|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
323889|NCT01187901|O2|Outcome|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
323890|NCT01187901|O1|Outcome|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
323891|NCT01187901|O2|Outcome|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
323892|NCT01187901|O1|Outcome|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
323893|NCT01187901|O2|Outcome|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
323894|NCT01187901|O1|Outcome|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
323895|NCT01187901|O2|Outcome|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
323896|NCT01187901|O1|Outcome|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
323897|NCT01187901|O2|Outcome|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
323898|NCT01187901|O1|Outcome|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
323899|NCT01187901|O2|Outcome|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
323900|NCT01187901|O1|Outcome|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
323901|NCT01187901|E2|Reported Event|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
323902|NCT01187901|E1|Reported Event|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
323903|NCT01187771|B3|Baseline|Total|Total of all reporting groups
323904|NCT01187771|B2|Baseline|Continuous Positive Airway Pressure|
323905|NCT01187771|B1|Baseline|Laparoscopic Gastric Banding|
323906|NCT01187771|P2|Participant Flow|Continuous Positive Airway Pressure|
323907|NCT01187771|P1|Participant Flow|Laparoscopic Gastric Banding|
323923|NCT01187771|O1|Outcome|Laparoscopic Gastric Banding|
323924|NCT01187771|E2|Reported Event|Continuous Positive Airway Pressure|
323925|NCT01187771|E1|Reported Event|Laparoscopic Gastric Banding|
323908|NCT01187771|O2|Outcome|Continuous Positive Airway Pressure|Continuous Positive Airway Pressure: Participants randomized to the CPAP arm will undergo a CPAP titration within 2 weeks of enrollment unless a split-night study was already performed as part of their diagnostic polysomnogram (PSG) providing a reliable CPAP therapeutic pressure. As soon as an appropriate pressure is identified, CPAP therapy will begin with routinely scheduled follow-up visits to maximize CPAP adherence. All participants will be offered a 12 month supervised weight loss program in addition to OSA-specific therapy.
323909|NCT01187771|O1|Outcome|Laparoscopic Gastric Banding|Laparoscopic Gastric Banding: Those randomized to surgery would meet with the bariatric surgeon and the dietitian during the 3 month weight management period and based on insurance requirements, would undergo LGB surgery after 3 months of weight management. PAP therapy would be utilized for the 3 week peri-operative period (1 week prior to 2 weeks post-operatively) given evidence that this might reduce peri-operative respiratory complications. Routine surgical follow-up will occur 2 weeks post-operatively and then every 4-6 weeks to assess weight loss trajectory and adjust the band as needed.
323910|NCT01187771|O2|Outcome|Continuous Positive Airway Pressure|Continuous Positive Airway Pressure: Participants randomized to the CPAP arm will undergo a CPAP titration within 2 weeks of enrollment unless a split-night study was already performed as part of their diagnostic polysomnogram (PSG) providing a reliable CPAP therapeutic pressure. As soon as an appropriate pressure is identified, CPAP therapy will begin with routinely scheduled follow-up visits to maximize CPAP adherence. All participants will be offered a 12 month supervised weight loss program in addition to OSA-specific therapy.
323911|NCT01187771|O1|Outcome|Laparoscopic Gastric Banding|Laparoscopic Gastric Banding: Those randomized to surgery would meet with the bariatric surgeon and the dietitian during the 3 month weight management period and based on insurance requirements, would undergo LGB surgery after 3 months of weight management. PAP therapy would be utilized for the 3 week peri-operative period (1 week prior to 2 weeks post-operatively) given evidence that this might reduce peri-operative respiratory complications. Routine surgical follow-up will occur 2 weeks post-operatively and then every 4-6 weeks to assess weight loss trajectory and adjust the band as needed.
323912|NCT01187771|O2|Outcome|Continuous Positive Airway Pressure|Continuous Positive Airway Pressure: Participants randomized to the CPAP arm will undergo a CPAP titration within 2 weeks of enrollment unless a split-night study was already performed as part of their diagnostic polysomnogram (PSG) providing a reliable CPAP therapeutic pressure. As soon as an appropriate pressure is identified, CPAP therapy will begin with routinely scheduled follow-up visits to maximize CPAP adherence. All participants will be offered a 12 month supervised weight loss program in addition to OSA-specific therapy.
323913|NCT01187771|O1|Outcome|Laparoscopic Gastric Banding|Laparoscopic Gastric Banding: Those randomized to surgery would meet with the bariatric surgeon and the dietitian during the 3 month weight management period and based on insurance requirements, would undergo LGB surgery after 3 months of weight management. PAP therapy would be utilized for the 3 week peri-operative period (1 week prior to 2 weeks post-operatively) given evidence that this might reduce peri-operative respiratory complications. Routine surgical follow-up will occur 2 weeks post-operatively and then every 4-6 weeks to assess weight loss trajectory and adjust the band as needed.
323914|NCT01187771|O2|Outcome|Continuous Positive Airway Pressure|Continuous Positive Airway Pressure: Participants randomized to the CPAP arm will undergo a CPAP titration within 2 weeks of enrollment unless a split-night study was already performed as part of their diagnostic polysomnogram (PSG) providing a reliable CPAP therapeutic pressure. As soon as an appropriate pressure is identified, CPAP therapy will begin with routinely scheduled follow-up visits to maximize CPAP adherence. All participants will be offered a 12 month supervised weight loss program in addition to OSA-specific therapy.
323915|NCT01187771|O1|Outcome|Laparoscopic Gastric Banding|Laparoscopic Gastric Banding: Those randomized to surgery would meet with the bariatric surgeon and the dietitian during the 3 month weight management period and based on insurance requirements, would undergo LGB surgery after 3 months of weight management. PAP therapy would be utilized for the 3 week peri-operative period (1 week prior to 2 weeks post-operatively) given evidence that this might reduce peri-operative respiratory complications. Routine surgical follow-up will occur 2 weeks post-operatively and then every 4-6 weeks to assess weight loss trajectory and adjust the band as needed.
323916|NCT01187771|O2|Outcome|Continuous Positive Airway Pressure|Continuous Positive Airway Pressure: Participants randomized to the CPAP arm will undergo a CPAP titration within 2 weeks of enrollment unless a split-night study was already performed as part of their diagnostic polysomnogram (PSG) providing a reliable CPAP therapeutic pressure. As soon as an appropriate pressure is identified, CPAP therapy will begin with routinely scheduled follow-up visits to maximize CPAP adherence. All participants will be offered a 12 month supervised weight loss program in addition to OSA-specific therapy.
323917|NCT01187771|O1|Outcome|Laparoscopic Gastric Banding|Laparoscopic Gastric Banding: Those randomized to surgery would meet with the bariatric surgeon and the dietitian during the 3 month weight management period and based on insurance requirements, would undergo LGB surgery after 3 months of weight management. PAP therapy would be utilized for the 3 week peri-operative period (1 week prior to 2 weeks post-operatively) given evidence that this might reduce peri-operative respiratory complications. Routine surgical follow-up will occur 2 weeks post-operatively and then every 4-6 weeks to assess weight loss trajectory and adjust the band as needed.
323918|NCT01187771|O2|Outcome|Continuous Positive Airway Pressure|Continuous Positive Airway Pressure: Participants randomized to the CPAP arm will undergo a CPAP titration within 2 weeks of enrollment unless a split-night study was already performed as part of their diagnostic polysomnogram (PSG) providing a reliable CPAP therapeutic pressure. As soon as an appropriate pressure is identified, CPAP therapy will begin with routinely scheduled follow-up visits to maximize CPAP adherence. All participants will be offered a 12 month supervised weight loss program in addition to OSA-specific therapy.
323919|NCT01187771|O1|Outcome|Laparoscopic Gastric Banding|Laparoscopic Gastric Banding: Those randomized to surgery would meet with the bariatric surgeon and the dietitian during the 3 month weight management period and based on insurance requirements, would undergo LGB surgery after 3 months of weight management. PAP therapy would be utilized for the 3 week peri-operative period (1 week prior to 2 weeks post-operatively) given evidence that this might reduce peri-operative respiratory complications. Routine surgical follow-up will occur 2 weeks post-operatively and then every 4-6 weeks to assess weight loss trajectory and adjust the band as needed.
323920|NCT01187771|O2|Outcome|Continuous Positive Airway Pressure|
323921|NCT01187771|O1|Outcome|Laparoscopic Gastric Banding|
323927|NCT01187550|B2|Baseline|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
323928|NCT01187550|B1|Baseline|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
323929|NCT01187550|P2|Participant Flow|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
323930|NCT01187550|P1|Participant Flow|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
323931|NCT01187550|O2|Outcome|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
323932|NCT01187550|O1|Outcome|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
323933|NCT01187550|O2|Outcome|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
323934|NCT01187550|O1|Outcome|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
323935|NCT01187550|O2|Outcome|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
323936|NCT01187550|O1|Outcome|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
323937|NCT01187550|O2|Outcome|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
323938|NCT01187550|O1|Outcome|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
323939|NCT01187550|O2|Outcome|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
323940|NCT01187550|O1|Outcome|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
323941|NCT01187550|O2|Outcome|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
323942|NCT01187550|O1|Outcome|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
323943|NCT01187550|E2|Reported Event|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
323944|NCT01187550|E1|Reported Event|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
323945|NCT01187511|B3|Baseline|Total|Total of all reporting groups
323946|NCT01187511|B2|Baseline|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323947|NCT01187511|B1|Baseline|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
323948|NCT01187511|P2|Participant Flow|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323949|NCT01187511|P1|Participant Flow|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
323950|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323951|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
323952|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323953|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
323954|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323955|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
323956|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323957|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
323958|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323959|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
323960|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323961|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
323962|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323963|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
323964|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323965|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
323966|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323967|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
323968|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323969|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
323970|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323971|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
323972|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323973|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
323974|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323975|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
323976|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323977|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
323978|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323979|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
323980|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323981|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
323982|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323983|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
323984|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323985|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
323986|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323987|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
323988|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323989|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
323990|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323991|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
323992|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323993|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
323994|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323995|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
323996|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323997|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
323998|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
323999|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324000|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324001|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324002|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324003|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324004|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324005|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324006|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324007|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324008|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324009|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324010|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324011|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324012|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324013|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324014|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324015|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324016|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324017|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324018|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324019|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324020|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324021|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324022|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324023|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324024|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324025|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324026|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324027|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324028|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324029|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324030|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324031|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324032|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324033|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324034|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324035|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324036|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324037|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324038|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324039|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324040|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324041|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324042|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324043|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324044|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324045|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324046|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324047|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324048|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324049|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324050|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324051|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324052|NCT01187511|E2|Reported Event|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
324053|NCT01187511|E1|Reported Event|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
324054|NCT01187498|B3|Baseline|Total|Total of all reporting groups
324055|NCT01187498|B2|Baseline|Drug Therapy|Individually titrated, extended release oxybutynin chloride
324056|NCT01187498|B1|Baseline|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
324057|NCT01187498|P2|Participant Flow|Drug Therapy|Individually titrated, extended-release oxybutynin chloride, 5-30mg
324058|NCT01187498|P1|Participant Flow|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
324059|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
324060|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
324061|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
324062|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
324063|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
324064|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
324065|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
324066|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
324067|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
324068|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
324069|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
324070|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
324071|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
324072|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
324073|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
324074|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
324075|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
324076|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
324077|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
324078|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
324079|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
324080|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
324081|NCT01187498|E2|Reported Event|Drug Therapy|Individually titrated, extended release oxybutynin chloride
324082|NCT01187498|E1|Reported Event|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
324084|NCT01187446|B2|Baseline|TSEBT Plus Vorinostat|"TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.~Vorinostat 400 mg/day concurrent and continuing for 8 weeks total."
324085|NCT01187446|B1|Baseline|TSEBT Only|• TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.
324086|NCT01187446|P2|Participant Flow|TSEBT Plus Vorinostat|"TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.~Vorinostat 400 mg/day continuing for 8 weeks total."
324087|NCT01187446|P1|Participant Flow|TSEBT Only|• TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.
324088|NCT01187446|O2|Outcome|TSEBT Plus Vorinostat|"TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.~Vorinostat 400 mg/day concurrent and continuing for 8 weeks total."
324089|NCT01187446|O1|Outcome|TSEBT Only|• TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.
324090|NCT01187446|O2|Outcome|TSEBT Plus Vorinostat|"TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.~Vorinostat 400 mg/day concurrent and continuing for 8 weeks total."
324091|NCT01187446|O1|Outcome|TSEBT Only|• TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.
324092|NCT01187446|O2|Outcome|TSEBT Plus Vorinostat|"TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.~Vorinostat 400 mg/day concurrent and continuing for 8 weeks total."
324093|NCT01187446|O1|Outcome|TSEBT Only|• TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.
324094|NCT01187446|O2|Outcome|TSEBT Plus Vorinostat|"TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.~Vorinostat 400 mg/day concurrent and continuing for 8 weeks total."
324095|NCT01187446|O1|Outcome|TSEBT Only|• TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.
324096|NCT01187446|O2|Outcome|TSEBT Plus Vorinostat|"TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.~Vorinostat 400 mg/day concurrent and continuing for 8 weeks total."
324097|NCT01187446|O1|Outcome|TSEBT Only|• TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.
324098|NCT01187446|E2|Reported Event|TSEBT & Vorinostat|"TSEBT (12Gy) per institutional guidelines.~Vorinostat 400 mg daily starting one day prior to the initiation of TSEBT."
324099|NCT01187446|E1|Reported Event|TSEBT Only|TSEBT (12Gy) per institutional guidelines.
324100|NCT01187433|B3|Baseline|Total|Total of all reporting groups
324101|NCT01187433|B2|Baseline|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
324102|NCT01187433|B1|Baseline|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
324103|NCT01187433|P2|Participant Flow|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
324104|NCT01187433|P1|Participant Flow|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
324105|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
324106|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
324107|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
324108|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
324109|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
324110|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
324111|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
324112|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
324113|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
324114|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
324115|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
324116|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
324117|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
324118|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
324119|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
324120|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
324121|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
324122|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
324123|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
324221|NCT01187355|P1|Participant Flow|Alcon MPDS|Multi-purpose disinfecting contact lens solution
324124|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
324125|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
324126|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
324127|NCT01187433|E2|Reported Event|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
324128|NCT01187433|E1|Reported Event|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
324129|NCT01187407|B5|Baseline|Total|Total of all reporting groups
324130|NCT01187407|B4|Baseline|Placebo + SSRI (Non-randomized Participants)|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
324131|NCT01187407|B3|Baseline|Placebo + SSRI (Randomized Participants)|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
324132|NCT01187407|B2|Baseline|6 mg LY2216684 + SSRI (Randomized Participants)|LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
324133|NCT01187407|B1|Baseline|12 or 18 mg LY2216684 + SSRI (Randomized Participants)|LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
324134|NCT01187407|P5|Participant Flow|Placebo + SSRI (Non-randomized Participants)|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
324135|NCT01187407|P4|Participant Flow|Placebo + SSRI (Randomized Participants)|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
324136|NCT01187407|P3|Participant Flow|6 mg LY2216684 + SSRI (Randomized Participants)|LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
324137|NCT01187407|P2|Participant Flow|12 or 18 mg LY2216684 + SSRI (Randomized Participants)|LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, QD for 8 weeks, adjunctive to an SSRI
324138|NCT01187407|P1|Participant Flow|Placebo + SSRI (Pre-randomized Participants)|Placebo: administered orally, once daily (QD) for 3 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
324139|NCT01187407|O1|Outcome|LY2216684|LY2216684: flexible dose of 12 or 18 milligrams (mg) or fixed dose of 6 mg, administered orally, once daily (QD)
324140|NCT01187407|O3|Outcome|Placebo + SSRI|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
324141|NCT01187407|O2|Outcome|6 mg Fixed Dose LY2216684 + SSRI|LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
324142|NCT01187407|O1|Outcome|12 or 18 mg Flexible Dose LY2216684 + SSRI|LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
324143|NCT01187407|O3|Outcome|Placebo + SSRI|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
324144|NCT01187407|O2|Outcome|6 mg Fixed Dose LY2216684 + SSRI|LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
324145|NCT01187407|O1|Outcome|12 or 18 mg Flexible Dose LY2216684 + SSRI|LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
324146|NCT01187407|O3|Outcome|Placebo + SSRI|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
324147|NCT01187407|O2|Outcome|6 mg Fixed Dose LY2216684 + SSRI|LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
324148|NCT01187407|O1|Outcome|12 or 18 mg Flexible Dose LY2216684 + SSRI|LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
324149|NCT01187407|O3|Outcome|Placebo + SSRI|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
324150|NCT01187407|O2|Outcome|6 mg Fixed Dose LY2216684 + SSRI|LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
324151|NCT01187407|O1|Outcome|12 or 18 mg Flexible Dose LY2216684 + SSRI|LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
324152|NCT01187407|O3|Outcome|Placebo + SSRI|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
324153|NCT01187407|O2|Outcome|6 mg Fixed Dose LY2216684 + SSRI|LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI)
324154|NCT01187407|O1|Outcome|12 or 18 mg Flexible Dose LY2216684 + SSRI|LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
324155|NCT01187407|O3|Outcome|Placebo + SSRI|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
324156|NCT01187407|O2|Outcome|6 mg Fixed Dose LY2216684 + SSRI|LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
324157|NCT01187407|O1|Outcome|12 or 18 mg Flexible Dose LY2216684 + SSRI|LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
324158|NCT01187407|O3|Outcome|Placebo + SSRI|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
324159|NCT01187407|O2|Outcome|6 mg Fixed Dose LY2216684 + SSRI|LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
324160|NCT01187407|O1|Outcome|12 or 18 mg Flexible Dose LY2216684 + SSRI|LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
324161|NCT01187407|O3|Outcome|Placebo + SSRI|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
324162|NCT01187407|O2|Outcome|6 mg Fixed Dose LY2216684 + SSRI|LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
324163|NCT01187407|O1|Outcome|12 or 18 mg Flexible Dose LY2216684 + SSRI|LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
324164|NCT01187407|O3|Outcome|Placebo + SSRI|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
324165|NCT01187407|O2|Outcome|6 mg Fixed Dose LY2216684 + SSRI|LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
324166|NCT01187407|O1|Outcome|12 or 18 mg Flexible Dose LY2216684 + SSRI|LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
324167|NCT01187407|O3|Outcome|Placebo + SSRI|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
324168|NCT01187407|O2|Outcome|6 mg Fixed Dose LY2216684 + SSRI|LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
324169|NCT01187407|O1|Outcome|12 or 18 mg Flexible Dose LY2216684 + SSRI|LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
324170|NCT01187407|O3|Outcome|Placebo + SSRI|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
324171|NCT01187407|O2|Outcome|6 mg Fixed Dose LY2216684 + SSRI|LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
324172|NCT01187407|O1|Outcome|12 or 18 mg Flexible Dose LY2216684 + SSRI|LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
324173|NCT01187407|O3|Outcome|Placebo + SSRI|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
324174|NCT01187407|O2|Outcome|6 mg Fixed Dose LY2216684 + SSRI|LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
324175|NCT01187407|O1|Outcome|12 or 18 mg Flexible Dose LY2216684 + SSRI|LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
324176|NCT01187407|O3|Outcome|Placebo + SSRI|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
324177|NCT01187407|O2|Outcome|6 mg Fixed Dose LY2216684 + SSRI|LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
324178|NCT01187407|O1|Outcome|12 or 18 mg Flexible Dose LY2216684 + SSRI|LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
324179|NCT01187407|O3|Outcome|Placebo + SSRI|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
324180|NCT01187407|O2|Outcome|6 mg Fixed Dose LY2216684 + SSRI|LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
324181|NCT01187407|O1|Outcome|12 or 18 mg Flexible Dose LY2216684 + SSRI|LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
324182|NCT01187407|O3|Outcome|Placebo + SSRI|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
324183|NCT01187407|O2|Outcome|6 mg Fixed Dose LY2216684 + SSRI|LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
324184|NCT01187407|O1|Outcome|12 or 18 mg Flexible Dose LY2216684 + SSRI|LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
324185|NCT01187407|O3|Outcome|Placebo + SSRI|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
324186|NCT01187407|O2|Outcome|6 mg Fixed Dose LY2216684 + SSRI|LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
324187|NCT01187407|O1|Outcome|12 or 18 mg Flexible Dose LY2216684 + SSRI|LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
324188|NCT01187407|O3|Outcome|Placebo + SSRI|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
324189|NCT01187407|O2|Outcome|6 mg Fixed Dose LY2216684 + SSRI|LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
324190|NCT01187407|O1|Outcome|12 or 18 mg Flexible Dose LY2216684 + SSRI|LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
324191|NCT01187407|O3|Outcome|Placebo + SSRI|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
324192|NCT01187407|O2|Outcome|6 mg Fixed Dose LY2216684 + SSRI|LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
324193|NCT01187407|O1|Outcome|12 or 18 mg Flexible Dose LY2216684 + SSRI|LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
324194|NCT01187407|O3|Outcome|Placebo + SSRI|Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
324195|NCT01187407|O2|Outcome|6 mg Fixed Dose LY2216684 + SSRI|LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
324196|NCT01187407|O1|Outcome|12 or 18 mg Flexible Dose LY2216684 + SSRI|LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
324197|NCT01187407|E10|Reported Event|Placebo + SSRI (Non-randomized) - DC Phase|"No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.~Includes all non-randomized participants who abruptly discontinued placebo either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
324198|NCT01187407|E9|Reported Event|Placebo + SSRI (Randomized) - DC Phase|"No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.~Includes all randomized participants who abruptly discontinued placebo either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
324199|NCT01187407|E8|Reported Event|6 mg LY2216684 + SSRI (Randomized) - DC Phase|"No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.~Includes all randomized participants who abruptly discontinued LY2216684 either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
324222|NCT01187355|O2|Outcome|Renu Fresh MPS|Multi-purpose contact lens solution
324223|NCT01187355|O1|Outcome|Alcon MPDS|Multi-purpose disinfecting contact lens solution
324224|NCT01187355|O2|Outcome|Renu Fresh MPS|Multi-purpose contact lens solution
324200|NCT01187407|E7|Reported Event|12 or 18 mg LY2216684 + SSRI (Randomized) - DC Phase|"No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.~Includes all randomized participants who abruptly discontinued LY2216684 either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
324201|NCT01187407|E6|Reported Event|Placebo + SSRI (Pre-randomized) - DC Phase|"No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.~Includes all enrolled participants who abruptly discontinued placebo after early withdrawal during the Confirmation (CF) Phase and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
324202|NCT01187407|E5|Reported Event|Placebo + SSRI (Non-randomized) - AT Phase|"Placebo: administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)~Includes all non-randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase."
324203|NCT01187407|E4|Reported Event|Placebo + SSRI (Randomized) - AT Phase|"Placebo: administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)~Includes randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase."
324204|NCT01187407|E3|Reported Event|6 mg LY2216684 + SSRI (Randomized) - AT Phase|"LY2216684: fixed dose of 6 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)~Includes randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase."
324205|NCT01187407|E2|Reported Event|12 or 18 mg LY2216684 + SSRI (Randomized) - AT Phase|"LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)~Includes randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase."
324206|NCT01187407|E1|Reported Event|Placebo + SSRI (Pre-randomized) - CF Phase|"Placebo: administered orally, once daily for 3 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)~Includes all enrolled who did not discontinue for the reason 'Lost to Follow-up' at the first post-baseline visit during the Confirmation (CF) Phase."
324207|NCT01187381|B1|Baseline|Participants With Breast Cancer|Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.
324208|NCT01187381|P1|Participant Flow|Participants With Breast Cancer|Participants with early or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.
324209|NCT01187381|O1|Outcome|Participants With Breast Cancer|Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.
324210|NCT01187381|O1|Outcome|Participants With Breast Cancer|Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.
324211|NCT01187381|O1|Outcome|Participants With Breast Cancer|Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.
324212|NCT01187381|O1|Outcome|Participants With Breast Cancer|Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.
324213|NCT01187381|O1|Outcome|Participants With Breast Cancer|Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.
324214|NCT01187381|O1|Outcome|Participants With Breast Cancer|Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.
324215|NCT01187381|O1|Outcome|Participants With Breast Cancer|Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.
324216|NCT01187381|E1|Reported Event|Participants With Breast Cancer|Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.
324217|NCT01187355|B3|Baseline|Total|Total of all reporting groups
324218|NCT01187355|B2|Baseline|Renu Fresh MPS|Multi-purpose contact lens solution
324225|NCT01187355|O1|Outcome|Alcon MPDS|Multi-purpose disinfecting contact lens solution
324226|NCT01187355|O2|Outcome|Renu Fresh MPS|Multi-purpose contact lens solution
324227|NCT01187355|O1|Outcome|Alcon MPDS|Multi-purpose disinfecting contact lens solution
324228|NCT01187355|E2|Reported Event|Renu Fresh MPS|Multi-purpose contact lens solution
324229|NCT01187355|E1|Reported Event|Alcon MPDS|Multi-purpose disinfecting contact lens solution
324230|NCT01187043|B6|Baseline|Total|Total of all reporting groups
324231|NCT01187043|B5|Baseline|ARM 5|"12 mg proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
324232|NCT01187043|B4|Baseline|ARM 4|"9 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
324233|NCT01187043|B3|Baseline|ARM 3|"6 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
324234|NCT01187043|B2|Baseline|ARM 2|"3 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
324235|NCT01187043|B1|Baseline|ARM 1|"1 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
324236|NCT01187043|P5|Participant Flow|ARM 5|"12 mg proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
324237|NCT01187043|P4|Participant Flow|ARM 4|"9 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
324238|NCT01187043|P3|Participant Flow|ARM 3|"6 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
324239|NCT01187043|P2|Participant Flow|ARM 2|"3 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
324240|NCT01187043|P1|Participant Flow|ARM 1|"1 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
324241|NCT01187043|O5|Outcome|ARM 5|"12 mg proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
324242|NCT01187043|O4|Outcome|ARM 4|"9 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
324243|NCT01187043|O3|Outcome|ARM 3|"6 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
324244|NCT01187043|O2|Outcome|ARM 2|"3 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
324245|NCT01187043|O1|Outcome|ARM 1|"1 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
324246|NCT01187043|E5|Reported Event|ARM 5|"12 mg proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
324247|NCT01187043|E4|Reported Event|ARM 4|"9 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
324248|NCT01187043|E3|Reported Event|ARM 3|"6 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
324249|NCT01187043|E2|Reported Event|ARM 2|"3 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
324250|NCT01187043|E1|Reported Event|ARM 1|"1 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
324251|NCT01187017|B1|Baseline|Refractory SAA|Refractory Severe aplastic anemia (SAA) subjects
324252|NCT01187017|P1|Participant Flow|Refractory SAA|Refractory Severe aplastic anemia (SAA) subjects
324253|NCT01187017|O1|Outcome|Response Rate at 6 Months|"Hematologic Response of Refractory Severe aplastic anemia (SAA) subjects to fludarabine and cyclophosphamide.~The refractory SAA subjects will receive fludarabine and cyclophosphamide. The blood counts will be evaluated to assess a hematologic response. The hematologic response will be defined as complete, partial or no response. The response will be evaluated at 6 months."
324254|NCT01187017|E1|Reported Event|Refractory SAA|Refractory Severe aplastic anemia (SAA) subjects
324255|NCT01187004|B3|Baseline|Total|Total of all reporting groups
324256|NCT01187004|B2|Baseline|Control Group|patients who don't develop acute lung injury after cardiac surgery with cardiopulmonary by pass
324257|NCT01187004|B1|Baseline|Acute Lung Injury (ALI) Group|patients who develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass
324258|NCT01187004|P2|Participant Flow|Control Group|patients who don't develop acute lung injury after cardiac surgery with cardiopulmonary by pass
324259|NCT01187004|P1|Participant Flow|Acute Lung Injury (ALI) Group|patients who develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass
324260|NCT01187004|O2|Outcome|Control Group|patients who didn't develope ALI. ICU length of stay was calculated up to 28 days, and patients who died before were considered as having the maximum value
324261|NCT01187004|O1|Outcome|ICU-LOS in Patients Developing ALI|Intensive care unit length of stay in patients developing acute lung injury. ICU length of stay was calculated up to 28 days, and patients who died before were considered as having the maximum value
324262|NCT01187004|O1|Outcome|Acute Lung Injury|Patients who developed acute lung injury (ALI) after cardiac surgery and during mechanical ventilation
324263|NCT01187004|E2|Reported Event|Control Group|patients who don't develop acute lung injury after cardiac surgery with cardiopulmonary by pass
324264|NCT01187004|E1|Reported Event|Acute Lung Injury (ALI) Group|patients who develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass
324265|NCT01186939|B1|Baseline|Azacitidine|Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day.
324266|NCT01186939|P1|Participant Flow|Azacitidine|Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day.
324267|NCT01186939|O1|Outcome|Azacitidine|Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day.
324313|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324268|NCT01186939|E1|Reported Event|Azacitidine|Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day.
324269|NCT01186848|B1|Baseline|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual side of a body within each subject to receive either 1550-nm erbium-doped fractionated laser treatment or the combination of the laser and ultrasound treatment for the treatment of striae.~Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side received micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on each side."
324270|NCT01186848|P1|Participant Flow|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual side of a body within each subject to receive either 1550-nm erbium-doped fractionated laser treatment or the combination of the laser and ultrasound treatment for the treatment of striae.~Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side received micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on each side."
324271|NCT01186848|O2|Outcome|Combination Treatment|Combination of micro-focused ultrasound and 1550nm-fractionated laser : The treated sites were randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side received micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on each side.
324272|NCT01186848|O1|Outcome|1550-nm Erbium-doped Fractionated Laser|1550-nm erbium-doped fractionated laser : Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side.
324273|NCT01186848|E2|Reported Event|Combination Treatment|Combination of micro-focused ultrasound and 1550nm-fractionated laser : The treated sites were randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side received micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on each side.
324274|NCT01186848|E1|Reported Event|1550-nm Erbium-doped Fractionated Laser|1550-nm erbium-doped fractionated laser : Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side.
324275|NCT01186796|B3|Baseline|Total|Total of all reporting groups
324276|NCT01186796|B2|Baseline|Saline Group|"Subjects are given 3 consecutive weekly injections of Saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
324277|NCT01186796|B1|Baseline|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
324278|NCT01186796|P2|Participant Flow|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
324279|NCT01186796|P1|Participant Flow|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
324280|NCT01186796|O2|Outcome|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
324314|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324315|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324281|NCT01186796|O1|Outcome|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
324282|NCT01186796|O2|Outcome|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
324283|NCT01186796|O1|Outcome|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
324284|NCT01186796|O2|Outcome|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
324285|NCT01186796|O1|Outcome|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
324286|NCT01186796|O2|Outcome|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
324287|NCT01186796|O1|Outcome|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
324288|NCT01186796|O2|Outcome|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
324289|NCT01186796|O1|Outcome|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
324290|NCT01186796|E2|Reported Event|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
324291|NCT01186796|E1|Reported Event|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
324292|NCT01186744|B7|Baseline|Total|Total of all reporting groups
324293|NCT01186744|B6|Baseline|CP-690,550 10 mg / Placebo / CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID or up to 28 weeks in Period C (Double-Blind Re-Treatment)
324294|NCT01186744|B5|Baseline|CP-690,550 10 mg/CP-690,550 10 mg/CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324295|NCT01186744|B4|Baseline|CP-690,550 5 mg/Placebo/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324296|NCT01186744|B3|Baseline|CP-690,550 5 mg/CP-690,550 5 mg/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324297|NCT01186744|B2|Baseline|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324298|NCT01186744|B1|Baseline|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324299|NCT01186744|P6|Participant Flow|CP-690,550 10 mg / Placebo / CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324300|NCT01186744|P5|Participant Flow|CP-690,550 10 mg/CP-690,550 10 mg/CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324301|NCT01186744|P4|Participant Flow|CP-690,550 5 mg/Placebo/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324302|NCT01186744|P3|Participant Flow|CP-690,550 5 mg/CP-690,550 5 mg/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324303|NCT01186744|P2|Participant Flow|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for up to 24 continuous weeks during Period A (Initial Treatment)
324304|NCT01186744|P1|Participant Flow|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for up to 24 continuous weeks during Period A (Initial Treatment)
324305|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324306|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324307|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324308|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324309|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324310|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324311|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324312|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
325354|NCT01185080|P1|Participant Flow|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
324316|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324317|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324318|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324319|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324320|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324321|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324322|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324323|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324324|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324325|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324326|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324327|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324328|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324329|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324330|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324331|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324332|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324333|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324334|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324335|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324336|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324337|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324338|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324339|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324340|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324341|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324395|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324342|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324343|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324344|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324345|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324346|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324347|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324348|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324349|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324350|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324351|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324352|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324353|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324354|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324355|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324356|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324357|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324358|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324359|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324360|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324361|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324362|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324363|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324364|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324365|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324366|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324367|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324731|NCT01186562|B3|Baseline|Total|Total of all reporting groups
324368|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324369|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324370|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324371|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324372|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324373|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324374|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324375|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324376|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324377|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324378|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324379|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324380|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324381|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324382|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324383|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324384|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324385|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324386|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324387|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324388|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324389|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324390|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324391|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324392|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324393|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324394|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324732|NCT01186562|B2|Baseline|Placebo|Placebo: Placebo
324733|NCT01186562|B1|Baseline|Sitagliptin|Sitagliptin: 100 mg PO daily
324396|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324397|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324398|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324399|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324400|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324401|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324402|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324403|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324404|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324405|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324406|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324407|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324408|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324409|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324410|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324411|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324412|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324413|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324414|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324415|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324416|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324417|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324418|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324419|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324420|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324421|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324422|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324423|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324424|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324425|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324426|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324427|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324428|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324429|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324430|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324431|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324432|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324433|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324434|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324435|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324436|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324437|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324438|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324439|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324440|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324441|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324442|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324443|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324444|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324445|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324446|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324447|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324734|NCT01186562|P2|Participant Flow|Placebo|Placebo: Placebo
324735|NCT01186562|P1|Participant Flow|Sitagliptin|Sitagliptin: 100 mg PO daily
324448|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324449|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324450|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324451|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324452|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324453|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324454|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324455|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324456|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324457|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324458|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324459|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324460|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324461|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324462|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324463|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324464|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324465|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324466|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324467|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324468|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324469|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324470|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324471|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324472|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324473|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324736|NCT01186562|O2|Outcome|Placebo|Placebo: Placebo
324474|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324475|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324476|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324477|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324478|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324479|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324480|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324481|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324482|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324483|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324484|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324485|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324486|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324487|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324488|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324489|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324490|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324491|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324492|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324493|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324494|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324495|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324496|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324497|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324498|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324499|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324500|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324737|NCT01186562|O1|Outcome|Sitagliptin|Sitagliptin: 100 mg PO daily
324738|NCT01186562|O2|Outcome|Placebo|Placebo: Placebo
324501|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324502|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324503|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324504|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324505|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324506|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324507|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324508|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324509|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324510|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324511|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324512|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324513|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324514|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324515|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324516|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324517|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324518|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324519|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324520|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324521|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324522|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324523|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324524|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324525|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324739|NCT01186562|O1|Outcome|Sitagliptin|Sitagliptin: 100 mg PO daily
324740|NCT01186562|O2|Outcome|Placebo|Placebo: Placebo
324741|NCT01186562|O1|Outcome|Sitagliptin|Sitagliptin: 100 mg PO daily
324526|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324527|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324528|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324529|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324530|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324531|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324532|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324533|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324534|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324535|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324536|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324537|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324538|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324539|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324540|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324541|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324542|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324543|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324544|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324545|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324546|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324547|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324548|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324549|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324550|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324551|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324742|NCT01186562|O2|Outcome|Placebo|Placebo: Placebo
324743|NCT01186562|O1|Outcome|Sitagliptin|Sitagliptin: 100 mg PO daily
324744|NCT01186562|O2|Outcome|Placebo|Placebo: Placebo
324552|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324553|NCT01186744|O2|Outcome|Placebo for CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324554|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324555|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment)
324556|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324557|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324558|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324559|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324560|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324561|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324562|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324563|NCT01186744|O2|Outcome|Placebo for CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324564|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324565|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment)
324566|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324567|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324568|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324569|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324570|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324571|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324572|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324573|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324574|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324575|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324576|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324577|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324745|NCT01186562|O1|Outcome|Sitagliptin|Sitagliptin: 100 mg PO daily
324746|NCT01186562|O2|Outcome|Placebo|Placebo: Placebo
324578|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324579|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324580|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324581|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324582|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324583|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324584|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324585|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324586|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324587|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324588|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324589|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324590|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324591|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324592|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324593|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324594|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324595|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324596|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324597|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324598|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324599|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324600|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324601|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324602|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324747|NCT01186562|O1|Outcome|Sitagliptin|Sitagliptin: 100 mg PO daily
324748|NCT01186562|E2|Reported Event|Placebo|Placebo: Placebo
324603|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324604|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324605|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324606|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324607|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324608|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324609|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324610|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324611|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324612|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324613|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324614|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324615|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324616|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324617|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324618|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324619|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324620|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324621|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324622|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324623|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324624|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324625|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324626|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324627|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324628|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324749|NCT01186562|E1|Reported Event|Sitagliptin|Sitagliptin: 100 mg PO daily
324629|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324630|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324631|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324632|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324633|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324634|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324635|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324636|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324637|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324638|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324639|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324640|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324641|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324642|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324643|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324644|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324645|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324646|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324647|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324648|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324649|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324650|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324651|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324652|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324653|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324779|NCT01186250|O2|Outcome|Placebo|"Placebo~Placebo: placebo taken daily for one year"
325355|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
324654|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324655|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324656|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324657|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324658|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324659|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324660|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324661|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324662|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324663|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324664|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324665|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324666|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324667|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324668|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324669|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324670|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324671|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324672|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324673|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324674|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324675|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324676|NCT01186744|O3|Outcome|CP-690,550 10 mg (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324677|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324853|NCT01185821|O5|Outcome|BAF312 .25 mg/2 mg|.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324678|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324679|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324680|NCT01186744|O3|Outcome|CP-690,550 10 mg (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324681|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324682|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324683|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324684|NCT01186744|O3|Outcome|CP-690,550 10 mg (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324685|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324686|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324687|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324688|NCT01186744|O3|Outcome|CP-690,550 10 mg (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324689|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324690|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324691|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324692|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324693|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324694|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324695|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324696|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324697|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324698|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324699|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324700|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324701|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324702|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324703|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324704|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324705|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324706|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324707|NCT01186744|O2|Outcome|Placebo for CP-690,550 5 mg (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324708|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324709|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324710|NCT01186744|O3|Outcome|CP-690,550 10 mg (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324711|NCT01186744|O2|Outcome|Placebo for CP-690,550 5 mg (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324712|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP690-550 5 mg for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
324713|NCT01186744|E6|Reported Event|CP-690,550 10 mg / Placebo / CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324714|NCT01186744|E5|Reported Event|CP-690,550 10 mg/CP-690,550 10 mg/CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 10 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324715|NCT01186744|E4|Reported Event|CP-690,550 5 mg/Placebo/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324716|NCT01186744|E3|Reported Event|CP-690,550 5 mg/CP-690,550 5 mg/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 5 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg for up to 28 weeks in Period C (Double-Blind Re-Treatment)
324717|NCT01186744|E2|Reported Event|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
324718|NCT01186744|E1|Reported Event|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
324719|NCT01186705|B1|Baseline|MK-2206|"This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens.~MK-2206: Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects."
324720|NCT01186705|P1|Participant Flow|MK-2206|"This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens.~MK-2206: Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects."
324721|NCT01186705|O1|Outcome|MK-2206|"This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens.~MK-2206: Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects."
324722|NCT01186705|E1|Reported Event|MK-2206|"This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens.~MK-2206: Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects."
324723|NCT01186692|B1|Baseline|Enrolled Cohort|All subjects enrolled.
324724|NCT01186692|P1|Participant Flow|Enrolled|All subjects enrolled (n=131)
324725|NCT01186692|O1|Outcome|Implanted > 24 Hours Cohort|The implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
324726|NCT01186692|O1|Outcome|Implanted Cohort|The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted.
324727|NCT01186692|O1|Outcome|Catheterized Cohort|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
324728|NCT01186692|O1|Outcome|Attempted Implant Cohort|The attempted implant cohort consists of all subjects who underwent catheterization and a Melody TPV implantation was attempted (Melody TPV valve opened).
324729|NCT01186692|O1|Outcome|Implanted >24 Hours Cohort|The implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
324730|NCT01186692|E1|Reported Event|Catheterized Cohort|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
324750|NCT01186458|B1|Baseline|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab~Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.~Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.~Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
324751|NCT01186458|P1|Participant Flow|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab~Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.~Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.~Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
324752|NCT01186458|O1|Outcome|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab~Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.~Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.~Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
324753|NCT01186458|O1|Outcome|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab~Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.~Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.~Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
324754|NCT01186458|O1|Outcome|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab~Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.~Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.~Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
324755|NCT01186458|O1|Outcome|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab~Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.~Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.~Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
324756|NCT01186458|E1|Reported Event|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab~Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.~Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.~Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
324757|NCT01186419|B3|Baseline|Total|Total of all reporting groups
324758|NCT01186419|B2|Baseline|SPD602 32 mg/kg/Day|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
324759|NCT01186419|B1|Baseline|SPD602 16 mg/kg/Day|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
324760|NCT01186419|P2|Participant Flow|SPD602 32 mg/kg/Day|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
324761|NCT01186419|P1|Participant Flow|SPD602 16 mg/kg/Day|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
324762|NCT01186419|O1|Outcome|SPD602|Participants received SPD602 orally once daily for up to 96 weeks.
324763|NCT01186419|O1|Outcome|SPD602|Participants received SPD602 orally once daily for up to 96 weeks.
324764|NCT01186419|O1|Outcome|SPD602|Participants received SPD602 orally once daily for up to 96 weeks.
324765|NCT01186419|E2|Reported Event|SPD602 32 mg/kg/d|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
324766|NCT01186419|E1|Reported Event|SPD602 16 mg/kg/d|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
324780|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
324781|NCT01186250|O2|Outcome|Placebo|"Placebo~Placebo: placebo taken daily for one year"
324782|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
324783|NCT01186250|O2|Outcome|Placebo|"Placebo~Placebo: placebo taken daily for one year"
324767|NCT01186406|B1|Baseline|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
324768|NCT01186406|P1|Participant Flow|Gliadel, Radiation Therapy, Avastin, Temodar|"Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation~Gliadel, Radiation Therapy, Avastin, Temodar: Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, they will be treated with standard radiation therapy, and daily Temodar (75mg/m2) for 6.5 weeks of radiation. In addition, Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively.~Beginning 2-3 weeks after the last radiation therapy, but not greater than 8 weeks, patients will be treated with Avastin (10 mg/kg) every 14 days along with 5 day Temodar (200 mg/ m2)."
324769|NCT01186406|O1|Outcome|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation. Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
324770|NCT01186406|O1|Outcome|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation. Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
324771|NCT01186406|O1|Outcome|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation. Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
324772|NCT01186406|O1|Outcome|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation. Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
324773|NCT01186406|E1|Reported Event|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation. Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
324774|NCT01186250|B3|Baseline|Total|Total of all reporting groups
324775|NCT01186250|B2|Baseline|Placebo|"Placebo~Placebo: placebo taken daily for one year"
324776|NCT01186250|B1|Baseline|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
324777|NCT01186250|P2|Participant Flow|Placebo|"Placebo~Placebo: placebo taken daily for one year"
324778|NCT01186250|P1|Participant Flow|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
324784|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
324785|NCT01186250|O2|Outcome|Placebo|"Placebo~Placebo: placebo taken daily for one year"
324786|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
324787|NCT01186250|O2|Outcome|Placebo|"Placebo~Placebo: placebo taken daily for one year"
324788|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
324789|NCT01186250|O2|Outcome|Placebo|"Placebo~Placebo: placebo taken daily for one year"
324790|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
324791|NCT01186250|O2|Outcome|Placebo|"Placebo~Placebo: placebo taken daily for one year"
324792|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
324793|NCT01186250|E2|Reported Event|Placebo|"Placebo~Placebo: placebo taken daily for one year"
324794|NCT01186250|E1|Reported Event|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
324795|NCT01185964|B4|Baseline|Total|Total of all reporting groups
324796|NCT01185964|B3|Baseline|Phase 2: Doxorubicin|"All cycles are 21 days.~Cycles 1-8: doxorubicin 75 mg/m2 on day 1~At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
324797|NCT01185964|B2|Baseline|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle"
324798|NCT01185964|B1|Baseline|Phase 1b: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
324799|NCT01185964|P4|Participant Flow|Phase 2: Doxorubicin: Optional Olaratumab After Progression|All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
324800|NCT01185964|P3|Participant Flow|Phase 2: Doxorubicin|"All cycles are 21 days.~Cycles 1-8: doxorubicin 75 mg/m2 on day 1~At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
324801|NCT01185964|P2|Participant Flow|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle"
324802|NCT01185964|P1|Participant Flow|Phase 1b: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
324803|NCT01185964|O3|Outcome|Phase 2: Doxorubicin: Optional Olaratumab After Progression|All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
324804|NCT01185964|O2|Outcome|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle"
324805|NCT01185964|O1|Outcome|Phase 1b: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
324806|NCT01185964|O1|Outcome|Phase 1b and Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
324807|NCT01185964|O1|Outcome|Phase 1b and Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
324808|NCT01185964|O1|Outcome|Phase 1b and Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
324809|NCT01185964|O1|Outcome|Phase 1b and Phase 2 Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
324810|NCT01185964|O2|Outcome|Phase 2: Doxorubicin|"All cycles are 21 days.~Cycles 1-8: doxorubicin 75 mg/m2 on day 1~At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
324811|NCT01185964|O1|Outcome|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle"
324812|NCT01185964|O3|Outcome|Phase 2: Doxorubicin: Optional Olaratumab After Progression|All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
324813|NCT01185964|O2|Outcome|Phase 2: Doxorubicin|"All cycles are 21 days.~Cycles 1-8: doxorubicin 75 mg/m2 on day 1~At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
324814|NCT01185964|O1|Outcome|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle"
325356|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
324815|NCT01185964|O2|Outcome|Phase 2: Doxorubicin|"All cycles are 21 days.~Cycles 1-8: doxorubicin 75 mg/m2 on day 1~At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
324816|NCT01185964|O1|Outcome|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle"
324817|NCT01185964|O3|Outcome|Phase 2: Doxorubicin: Optional Olaratumab After Progression|All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
324818|NCT01185964|O2|Outcome|Phase 2: Doxorubicin|"All cycles are 21 days.~Cycles 1-8: doxorubicin 75 mg/m2 on day 1~At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
324819|NCT01185964|O1|Outcome|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle."
324820|NCT01185964|O1|Outcome|Phase 1b: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1~All subsequent cycles until progression: Olaratumab 15 mg/kg on days 1+8~Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle~Doxorubicin 75 mg/m2 by intravenous injection on day 1 of the 21-day cycle."
324821|NCT01185964|O2|Outcome|Phase 2: Doxorubicin|"All cycles are 21 days.~Cycles 1-8: doxorubicin 75 mg/m2 on day 1~At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
324822|NCT01185964|O1|Outcome|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1~All subsequent cycles until progression: Olaratumab 15 mg/kg on days 1+8~Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle~Doxorubicin 75 mg/m2 by IV on day 1 of the 21-day cycle."
324823|NCT01185964|E4|Reported Event|Phase 2: Doxorubicin: Optional Olaratumab After Progression|All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
324824|NCT01185964|E3|Reported Event|Phase 2: Doxorubicin|"All cycles are 21 days.~Cycles 1-8: doxorubicin 75 mg/m2 on day 1~At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
324825|NCT01185964|E2|Reported Event|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle"
324826|NCT01185964|E1|Reported Event|Phase 1b: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
324827|NCT01185834|B1|Baseline|Lotrafilcon A|Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
324828|NCT01185834|P1|Participant Flow|Lotrafilcon A|Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
324829|NCT01185834|O1|Outcome|Lotrafilcon A|Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
324830|NCT01185834|O1|Outcome|Lotrafilcon A|Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
324831|NCT01185834|E1|Reported Event|Lotrafilcon A|Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
324832|NCT01185821|B6|Baseline|Total|Total of all reporting groups
324833|NCT01185821|B5|Baseline|BAF312 .25 mg/2 mg|.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324834|NCT01185821|B4|Baseline|BAF312 .5 mg/2 mg|.5 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324835|NCT01185821|B3|Baseline|BAF312 1.25 mg/2 mg|1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324836|NCT01185821|B2|Baseline|BAF312 2 mg/2 mg|2 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324837|NCT01185821|B1|Baseline|BAF312 10 mg/2 mg|10 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324838|NCT01185821|P5|Participant Flow|BAF312 .25 mg/2 mg|.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324839|NCT01185821|P4|Participant Flow|BAF312 .5 mg/2 mg|.5 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324840|NCT01185821|P3|Participant Flow|BAF312 1.25 mg/2 mg|1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324841|NCT01185821|P2|Participant Flow|BAF312 2 mg/2 mg|2 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324842|NCT01185821|P1|Participant Flow|BAF312 10 mg/2 mg|10 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324843|NCT01185821|O5|Outcome|BAF312 .25 mg/2 mg|.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324844|NCT01185821|O4|Outcome|BAF312 .5 mg/2 mg|.5 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324845|NCT01185821|O3|Outcome|BAF312 1.25 mg/2 mg|1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324846|NCT01185821|O2|Outcome|BAF312 2 mg/2 mg|2 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324847|NCT01185821|O1|Outcome|BAF312 10 mg/2 mg|10 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324848|NCT01185821|O5|Outcome|BAF312 .25 mg/2 mg|.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324849|NCT01185821|O4|Outcome|BAF312 .5 mg/2 mg|.5 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324850|NCT01185821|O3|Outcome|BAF312 1.25 mg/2 mg|1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324851|NCT01185821|O2|Outcome|BAF312 2 mg/2 mg|2 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324852|NCT01185821|O1|Outcome|BAF312 10 mg/2 mg|10 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324854|NCT01185821|O4|Outcome|BAF312 .5 mg/2 mg|.5 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324855|NCT01185821|O3|Outcome|BAF312 1.25 mg/2 mg|1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324856|NCT01185821|O2|Outcome|BAF312 2 mg/2 mg|2 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324857|NCT01185821|O1|Outcome|BAF312 10 mg/2 mg|10 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324858|NCT01185821|O5|Outcome|BAF312 .25 mg/2 mg|.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324859|NCT01185821|O4|Outcome|BAF312 .5 mg/2 mg|.5 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324860|NCT01185821|O3|Outcome|BAF312 1.25 mg/2 mg|1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324861|NCT01185821|O2|Outcome|BAF312 2 mg/2 mg|2 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324862|NCT01185821|O1|Outcome|BAF312 10 mg/2 mg|10 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324863|NCT01185821|O5|Outcome|BAF312 .25 mg/2 mg|.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324864|NCT01185821|O4|Outcome|BAF312 .5 mg/2 mg|.5 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324865|NCT01185821|O3|Outcome|BAF312 1.25 mg/2 mg|1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324866|NCT01185821|O2|Outcome|BAF312 2 mg/2 mg|2 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324867|NCT01185821|O1|Outcome|BAF312 10 mg/2 mg|10 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324868|NCT01185821|O5|Outcome|BAF312 .25 mg/2 mg|.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324869|NCT01185821|O4|Outcome|BAF312 .5 mg/2 mg|.5 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324870|NCT01185821|O3|Outcome|BAF312 1.25 mg/2 mg|1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324871|NCT01185821|O2|Outcome|BAF312 2 mg/2 mg|2 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324872|NCT01185821|O1|Outcome|BAF312 10 mg/2 mg|10 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324873|NCT01185821|O1|Outcome|BAF312 .25 mg/2 mg|.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324874|NCT01185821|O5|Outcome|BAF312 .25 mg/2 mg|.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324875|NCT01185821|O4|Outcome|BAF312 .5 mg/2 mg|.5 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324876|NCT01185821|O3|Outcome|BAF312 1.25 mg/2 mg|1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324877|NCT01185821|O2|Outcome|BAF312 2 mg/2 mg|2 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324878|NCT01185821|O1|Outcome|BAF312 10 mg/2 mg|10 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324879|NCT01185821|O5|Outcome|BAF312 .25 mg/2 mg|.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324880|NCT01185821|O4|Outcome|BAF312 .5 mg/2 mg|.5 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324881|NCT01185821|O3|Outcome|BAF312 1.25 mg/2 mg|1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324882|NCT01185821|O2|Outcome|BAF312 2 mg/2 mg|2 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324883|NCT01185821|O1|Outcome|BAF312 10 mg/2 mg|10 mg dose in Double Blind Phase and 2 mg in Open Label Phase
324884|NCT01185821|E6|Reported Event|All Patients|All patients
324885|NCT01185821|E5|Reported Event|BAF312 0.25/2 mg|BAF312 0.25/2 mg
324886|NCT01185821|E4|Reported Event|BAF312 0.5/2 mg|BAF312 0.5/2 mg
324887|NCT01185821|E3|Reported Event|BAF312 1.25/2 mg|BAF312 1.25/2 mg
324888|NCT01185821|E2|Reported Event|BAF312 2/2 mg|BAF312 2/2 mg
324889|NCT01185821|E1|Reported Event|BAF312 10/2 mg|BAF312 10/2 mg
324890|NCT01185782|B3|Baseline|Total|Total of all reporting groups
324891|NCT01185782|B2|Baseline|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324892|NCT01185782|B1|Baseline|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324893|NCT01185782|P2|Participant Flow|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324894|NCT01185782|P1|Participant Flow|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324895|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324896|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324897|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324898|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
325357|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
324899|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324900|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324901|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324902|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324903|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324904|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324905|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324906|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324907|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324908|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324909|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324910|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324911|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324912|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324913|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324914|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324915|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324916|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324917|NCT01185782|E2|Reported Event|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324918|NCT01185782|E1|Reported Event|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
324919|NCT01185704|B3|Baseline|Total|Total of all reporting groups
325111|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
324920|NCT01185704|B2|Baseline|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324921|NCT01185704|B1|Baseline|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324922|NCT01185704|P2|Participant Flow|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324923|NCT01185704|P1|Participant Flow|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324924|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324925|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324926|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324927|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324928|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324929|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324930|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324931|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324932|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324933|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324934|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324950|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324935|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324936|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324937|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324938|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324939|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324940|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324941|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324942|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324943|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324944|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324945|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324946|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324947|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324948|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324949|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324988|NCT01185561|O2|Outcome|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
325358|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
324951|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324952|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324953|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324954|NCT01185704|E2|Reported Event|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324955|NCT01185704|E1|Reported Event|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
324956|NCT01185600|B3|Baseline|Total|Total of all reporting groups
324957|NCT01185600|B2|Baseline|Transfusion With Unwashed RBC|"Subjects assigned to this arm will be transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency and duration for transfusion with unwashed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
324958|NCT01185600|B1|Baseline|Transfusion With Washed RBC|"Subject assigned to this arm will be transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency and duration for transfusion with washed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
324959|NCT01185600|P2|Participant Flow|Transfusion With Unwashed RBC|"Subjects assigned to this arm will be transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency and duration for transfusion with unwashed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
324960|NCT01185600|P1|Participant Flow|Transfusion With Washed RBC|"Subject assigned to this arm will be transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency and duration for transfusion with washed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
324961|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
324962|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
324963|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm will be transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency and duration for transfusion with unwashed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
324964|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subject assigned to this arm will be transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency and duration for transfusion with washed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
324965|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm will be transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency and duration for transfusion with unwashed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
324966|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subject assigned to this arm will be transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency and duration for transfusion with washed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
324967|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
324968|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
325017|NCT01185522|E1|Reported Event|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
325018|NCT01185509|B3|Baseline|Total|Total of all reporting groups
324969|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
324970|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
324971|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
324972|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
324973|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
324974|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency,or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
324975|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
324976|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
324977|NCT01185600|E2|Reported Event|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
324978|NCT01185600|E1|Reported Event|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
324979|NCT01185561|B3|Baseline|Total|Total of all reporting groups
324980|NCT01185561|B2|Baseline|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
324981|NCT01185561|B1|Baseline|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes~Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
324982|NCT01185561|P2|Participant Flow|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes~Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
324983|NCT01185561|P1|Participant Flow|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
324984|NCT01185561|O2|Outcome|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
324985|NCT01185561|O1|Outcome|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes~Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
324986|NCT01185561|O2|Outcome|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
324987|NCT01185561|O1|Outcome|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes~Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
324989|NCT01185561|O1|Outcome|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes~Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
324990|NCT01185561|O2|Outcome|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
324991|NCT01185561|O1|Outcome|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes~Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
324992|NCT01185561|E2|Reported Event|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
324993|NCT01185561|E1|Reported Event|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes~Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
324994|NCT01185522|B1|Baseline|Tocilizumab|Participants who received tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
324995|NCT01185522|P1|Participant Flow|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
324996|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
324997|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
324998|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
324999|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
325000|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
325001|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
325002|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
325003|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
325004|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
325005|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
325006|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
325007|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
325008|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
325009|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
325010|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
325011|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
325012|NCT01185522|O1|Outcome|Tocilizumab|Participants who received tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
325013|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
325014|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
325015|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
325016|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
325043|NCT01185353|P4|Participant Flow|8 mg LY3009104 QD - Parts A and B|"Administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325019|NCT01185509|B2|Baseline|Trastuzumab and Vinorelbine - Main Cohort|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
325020|NCT01185509|B1|Baseline|Trastuzumab and Vinorelbine - Cohort A|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
325021|NCT01185509|P2|Participant Flow|Trastuzumab and Vinorelbine - Main Cohort|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
325022|NCT01185509|P1|Participant Flow|Trastuzumab and Vinorelbine - Cohort A|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
325023|NCT01185509|O2|Outcome|Trastuzumab and Vinorelbine - Main Cohort|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
325024|NCT01185509|O1|Outcome|Trastuzumab and Vinorelbine - Cohort A|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
325025|NCT01185509|O2|Outcome|Trastuzumab and Vinorelbine - Main Cohort|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
325026|NCT01185509|O1|Outcome|Trastuzumab and Vinorelbine - Cohort A|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
325027|NCT01185509|O2|Outcome|Trastuzumab and Vinorelbine - Main Cohort|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
325359|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
325028|NCT01185509|O1|Outcome|Trastuzumab and Vinorelbine - Cohort A|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
325029|NCT01185509|E2|Reported Event|Trastuzumab and Vinorelbine - Main Cohort|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
325030|NCT01185509|E1|Reported Event|Trastuzumab and Vinorelbine - Cohort A|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
325031|NCT01185353|B6|Baseline|Total|Total of all reporting groups
325032|NCT01185353|B5|Baseline|Placebo|"Placebo administered orally QD for initial 12 weeks (Part A) followed by randomization to either 4 mg QD or 2 mg BID for an additional 12 weeks (Part B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks.~MTX was administered orally as background therapy."
325033|NCT01185353|B4|Baseline|8 mg LY3009104|"Administered orally QD for 24 weeks (Parts A and B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks.~MTX was administered orally as background therapy."
325034|NCT01185353|B3|Baseline|4 mg LY3009104|"Administered orally QD for 24 weeks (Parts A and B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks.~MTX was administered orally as background therapy."
325035|NCT01185353|B2|Baseline|2 mg LY3009104|"Administered orally QD for 24 weeks (Parts A and B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks.~MTX was administered orally as background therapy."
325036|NCT01185353|B1|Baseline|1 mg LY3009104|"Administered orally QD for initial 12 weeks (Part A) followed by randomization to either 4 mg QD or 2 mg BID for an additional 12 weeks (Part B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks.~MTX was administered orally as background therapy."
325037|NCT01185353|P10|Participant Flow|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Participants who received 8 mg LY3009104 QD in Part B remained on 8 mg LY3009104 QD in Part C.~Participants who completed Part C received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325038|NCT01185353|P9|Participant Flow|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C.~Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C.~At Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥ 6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Participants who completed Part C received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325039|NCT01185353|P8|Participant Flow|4 mg LY3009104 QD - Parts C and D|"Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C.~Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C.~Participants who completed Part C continued to receive 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325040|NCT01185353|P7|Participant Flow|4 mg LY3009104 QD - Part B|"Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 4 mg LY3009104 QD in Part B.~MTX was administered orally as background therapy."
325041|NCT01185353|P6|Participant Flow|2 mg LY3009104 BID - Part B|"Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 2 mg LY3009104 twice daily (BID) in Part B.~MTX was administered orally as background therapy."
325042|NCT01185353|P5|Participant Flow|Placebo QD - Part A|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325360|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
325044|NCT01185353|P3|Participant Flow|4 mg LY3009104 QD - Parts A and B|"Administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325045|NCT01185353|P2|Participant Flow|2 mg LY3009104 QD - Parts A and B|"Administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325046|NCT01185353|P1|Participant Flow|1 Milligrams (mg) LY3009104 QD - Part A|"Administered orally once daily (QD) for 12 weeks in Part A.~Methotrexate (MTX) was administered orally as background therapy."
325047|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325048|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325049|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325050|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325051|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325052|NCT01185353|O4|Outcome|8 mg LY3009104|8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B. MTX was administered orally as background therapy.
325053|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 4 mg LY3009104 QD in Part B.~MTX was administered orally as background therapy."
325054|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 2 mg LY3009104 BID in Part B.~MTX was administered orally as background therapy."
325055|NCT01185353|O1|Outcome|1mg LY3009104|1 mg LY3009104 administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.
325056|NCT01185353|O4|Outcome|8 mg LY3009104|8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B. MTX was administered orally as background therapy.
325057|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 4 mg LY3009104 QD in Part B.~MTX was administered orally as background therapy."
325058|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 2 mg LY3009104 BID in Part B.~MTX was administered orally as background therapy."
325059|NCT01185353|O1|Outcome|1 mg LY3009104|1 mg LY3009104 administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.
325060|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325061|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325062|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325063|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325064|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325065|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325066|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325067|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325068|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325069|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325070|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325071|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325072|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325073|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325074|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325075|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325076|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325077|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325078|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325079|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325080|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325109|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325110|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325361|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
325081|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325082|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325083|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325084|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325085|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325086|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325087|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325088|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325089|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥ 6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325090|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325091|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325092|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325093|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325094|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325095|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325096|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325097|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325098|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325099|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325100|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325101|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325102|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325103|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325104|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325105|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325106|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325107|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325108|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325112|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325113|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325114|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325115|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325116|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325117|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325118|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325119|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325120|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325121|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325122|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325123|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325124|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325125|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325126|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325127|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325128|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325129|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325130|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325131|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325132|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325133|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325134|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325135|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325136|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325137|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325138|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325139|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325140|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325141|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325142|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325143|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325144|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325145|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325146|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325147|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325148|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325149|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325150|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325151|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325152|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325153|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325154|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325155|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325156|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325157|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325158|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325159|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325160|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325161|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325162|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325163|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325164|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325165|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325166|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325167|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325168|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325169|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325170|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325171|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325362|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
325172|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325173|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325174|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325175|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325176|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
325177|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325178|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325179|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325180|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325181|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325182|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325183|NCT01185353|O2|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325184|NCT01185353|O1|Outcome|4 or 8 mg LY3009104|"4 or 8 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325185|NCT01185353|E18|Reported Event|Follow-Up|"Up to 28 days post the last dose of study drug.~MTX was administered orally as background therapy."
325186|NCT01185353|E17|Reported Event|8/4 mg LY3009104 QD - Part D|"Participants who received 8 mg LY3009104 QD in Part C received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325187|NCT01185353|E16|Reported Event|4 mg LY3009104 QD (4 to 8 mg Rescue)- Part D|"Participants who received 8 mg LY3009104 QD rescue treatment in Part C received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325188|NCT01185353|E15|Reported Event|4 mg LY3009104 QD - Part D|"Participants who received 4 mg LY3009104 QD in Part C continued to receive 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
325189|NCT01185353|E14|Reported Event|8 mg LY3009104 QD - Part C|"Participants who received 8 mg LY3009104 QD in Part B remained on 8 mg LY3009104 QD in Part C.~MTX was administered orally as background therapy."
325190|NCT01185353|E13|Reported Event|4 to 8 mg LY3009104 QD Post-Rescue - Part C|"Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C.~Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C.~During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD (rescue treatment) for the rest of the Part C.~MTX was administered orally as background therapy.~Adverse events were collected from predose of 8 mg LY3009104 QD until Week 76."
325191|NCT01185353|E12|Reported Event|4 to 8 mg LY3009104 QD Pre-Rescue - Part C|"Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C.~Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C.~During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD (rescue treatment) for the rest of the Part C.~MTX was administered orally as background therapy.~Adverse events were collected from Week 24 until predose of 8 mg LY3009104 QD."
325192|NCT01185353|E11|Reported Event|4 mg LY3009104 QD - Part C|"Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C.~Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C.~MTX was administered orally as background therapy."
325193|NCT01185353|E10|Reported Event|8 mg LY3009104 QD - Part B|"Participants who received 8 mg LY3009104 QD in Part A continued to receive 8 mg LY3009104 QD in Part B.~MTX was administered orally as background therapy."
325194|NCT01185353|E9|Reported Event|4 mg LY3009104 QD - Part B|"Participants who received 4 mg LY3009104 QD in Part A continued to receive 4 mg LY3009104 QD in Part B.~MTX was administered orally as background therapy."
325195|NCT01185353|E8|Reported Event|2 mg LY3009104 QD - Part B|"Participants who received 2 mg LY3009104 QD in Part A continued to receive 2 mg LY3009104 QD in Part B.~MTX was administered orally as background therapy."
325196|NCT01185353|E7|Reported Event|4 mg LY3009104 QD Crossover- Part B|"Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 4 mg LY3009104 QD in Part B.~MTX was administered orally as background therapy."
325197|NCT01185353|E6|Reported Event|2 mg LY3009104 BID Crossover- Part B|"Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 2 mg LY3009104 BID in Part B.~MTX was administered orally as background therapy."
325198|NCT01185353|E5|Reported Event|Placebo QD - Part A|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325199|NCT01185353|E4|Reported Event|8 mg LY3009104 QD - Part A|"Administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325200|NCT01185353|E3|Reported Event|4 mg LY3009104 QD - Part A|"Administered orally QD for 12 weeks in Pat A.~MTX was administered orally as background therapy."
325201|NCT01185353|E2|Reported Event|2 mg LY3009104 QD - Part A|"Administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325202|NCT01185353|E1|Reported Event|1 mg LY3009104 QD - Part A|"Administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
325203|NCT01185340|B4|Baseline|Total|Total of all reporting groups
325204|NCT01185340|B3|Baseline|Placebo + SSRI (Non-randomized Participants)|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325311|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325205|NCT01185340|B2|Baseline|Placebo + SSRI (Randomized Participants)|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325206|NCT01185340|B1|Baseline|LY2216684 + SSRI (Randomized Participants)|LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325207|NCT01185340|P4|Participant Flow|Placebo + SSRI (Non-randomized Participants)|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325208|NCT01185340|P3|Participant Flow|Placebo + SSRI (Randomized Participants)|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325209|NCT01185340|P2|Participant Flow|LY2216684 + SSRI (Randomized Participants)|LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325210|NCT01185340|P1|Participant Flow|Placebo + SSRI (Pre-randomized Participants)|Placebo: Administered orally, once daily for 3 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325211|NCT01185340|O2|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325212|NCT01185340|O1|Outcome|LY2216684 + SSRI|LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325213|NCT01185340|O2|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325214|NCT01185340|O1|Outcome|LY2216684 + SSRI|LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325215|NCT01185340|O2|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325216|NCT01185340|O1|Outcome|LY2216684 + SSRI|LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325217|NCT01185340|O2|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325218|NCT01185340|O1|Outcome|LY2216684 + SSRI|LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325219|NCT01185340|O2|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325220|NCT01185340|O1|Outcome|LY2216684 + SSRI|LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325221|NCT01185340|O2|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325222|NCT01185340|O1|Outcome|LY2216684 + SSRI|LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325223|NCT01185340|O2|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325224|NCT01185340|O1|Outcome|LY2216684 + SSRI|LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325225|NCT01185340|O2|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325226|NCT01185340|O1|Outcome|LY2216684 + SSRI|LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325227|NCT01185340|O2|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325228|NCT01185340|O1|Outcome|LY2216684 + SSRI|LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325229|NCT01185340|O2|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325230|NCT01185340|O1|Outcome|LY2216684 + SSRI|LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325231|NCT01185340|O2|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325232|NCT01185340|O1|Outcome|LY2216684 + SSRI|LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325233|NCT01185340|O2|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325234|NCT01185340|O1|Outcome|LY2216684 + SSRI|LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325235|NCT01185340|O2|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325236|NCT01185340|O1|Outcome|LY2216684 + SSRI|LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325237|NCT01185340|O2|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325238|NCT01185340|O1|Outcome|LY2216684 + SSRI|LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325239|NCT01185340|O2|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325240|NCT01185340|O1|Outcome|LY2216684 + SSRI|LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325241|NCT01185340|O2|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325242|NCT01185340|O1|Outcome|LY2216684 + SSRI|LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325243|NCT01185340|O2|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325244|NCT01185340|O1|Outcome|LY2216684 + SSRI|LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325245|NCT01185340|O2|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325246|NCT01185340|O1|Outcome|LY2216684 + SSRI|LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325247|NCT01185340|O2|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325248|NCT01185340|O1|Outcome|LY2216684 + SSRI|LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
325249|NCT01185340|E8|Reported Event|Placebo + SSRI (Non-randomized) - DC Phase|"No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.~Includes all non-randomized participants who abruptly discontinued placebo either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason ‘Lost to Follow-up’ at the Discontinuation (DC) Phase visit."
325250|NCT01185340|E7|Reported Event|Placebo + SSRI (Randomized) - DC Phase|"No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.~Includes all randomized participants who abruptly discontinued placebo either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason ‘Lost to Follow-up’ at the Discontinuation (DC) Phase visit."
325251|NCT01185340|E6|Reported Event|LY2216684 + SSRI (Randomized) - DC Phase|"No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.~Includes all randomized participants who abruptly discontinued LY2216684 either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason ‘Lost to Follow-up’ at the Discontinuation (DC) Phase visit."
325252|NCT01185340|E5|Reported Event|Placebo + SSRI (Pre-randomized) - DC Phase|"No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.~Includes all enrolled participants who abruptly discontinued placebo after early withdrawal during the Confirmation (CF) Phase and who did not discontinue for the reason ‘Lost to Follow-up’ at the Discontinuation (DC) Phase visit."
325253|NCT01185340|E4|Reported Event|Placebo + SSRI (Non-randomized) - AT Phase|"Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)~Includes all non-randomized participants who did not discontinue for the reason ‘Lost to Follow-up’ at the first post-randomization visit during the Adjunctive Treatment (AT) Phase."
325254|NCT01185340|E3|Reported Event|Placebo + SSRI (Randomized) - AT Phase|"Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)~Includes randomized participants who did not discontinue for the reason ‘Lost to Follow-up’ at the first post-randomization visit during the Adjunctive Treatment (AT) Phase."
325255|NCT01185340|E2|Reported Event|LY2216684 + SSRI (Randomized) - AT Phase|"LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)~Includes randomized participants who did not discontinue for the reason ‘Lost to Follow-up’ at the first post-randomization visit during the Adjunctive Treatment (AT) Phase."
325256|NCT01185340|E1|Reported Event|Placebo + SSRI (Pre-randomized) - CF Phase|"Placebo: Administered orally, once daily for 3 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)~Includes all enrolled participants who did not discontinue for the reason ‘Lost to Follow-up’ at the first post-baseline visit during the Confirmation (CF) Phase."
325257|NCT01185301|B5|Baseline|Total|Total of all reporting groups
325258|NCT01185301|B4|Baseline|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
325259|NCT01185301|B3|Baseline|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325260|NCT01185301|B2|Baseline|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325261|NCT01185301|B1|Baseline|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
325262|NCT01185301|P4|Participant Flow|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
325263|NCT01185301|P3|Participant Flow|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325264|NCT01185301|P2|Participant Flow|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325265|NCT01185301|P1|Participant Flow|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
325266|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
325267|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325268|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325269|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
325270|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
325271|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325272|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325312|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325273|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
325274|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
325275|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325276|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325277|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
325278|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
325279|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325280|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325281|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
325282|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
325283|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325284|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325285|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
325286|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
325287|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325288|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325289|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
325290|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
325291|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325292|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325293|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
325294|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
325295|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325296|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325297|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
325298|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
325299|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325300|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325301|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
325302|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
325303|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325304|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325305|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
325306|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
325307|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325308|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325309|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
325310|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
325352|NCT01185080|P3|Participant Flow|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
325313|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
325314|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
325315|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325316|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325317|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
325318|NCT01185301|E4|Reported Event|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
325319|NCT01185301|E3|Reported Event|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325320|NCT01185301|E2|Reported Event|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
325321|NCT01185301|E1|Reported Event|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
325322|NCT01185288|B3|Baseline|Total|Total of all reporting groups
325323|NCT01185288|B2|Baseline|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
325324|NCT01185288|B1|Baseline|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
325325|NCT01185288|P2|Participant Flow|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
325326|NCT01185288|P1|Participant Flow|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
325327|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
325328|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
325329|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
325330|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
325331|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
325332|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
325333|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
325334|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
325335|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
325336|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
325337|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
325338|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
325339|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
325340|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
325341|NCT01185288|E2|Reported Event|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
325342|NCT01185288|E1|Reported Event|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
325343|NCT01185249|B1|Baseline|Body Weight Taken in a Standing Position|Subjects will be weighed in the early morning, as standard of care dictates. They will also be weighed after evening medications are given, around 9pm. The evening weight is not standard, therefore considered the study intervention.
325344|NCT01185249|P1|Participant Flow|Body Weight Taken in a Standing Position|Subjects will be weighed in the early morning, as standard of care dictates. They will also be weighed after evening medications are given, around 9pm. The evening weight is not standard, therefore considered the study intervention.
325345|NCT01185249|O2|Outcome|Morning Weight|Weight of study patients in kilograms first thing in the morning.
325346|NCT01185249|O1|Outcome|Evening Weights|Patients with both morning and evening weights
325347|NCT01185249|E1|Reported Event|Body Weight Taken in a Standing Position|Subjects will be weighed in the early morning, as standard of care dictates. They will also be weighed after evening medications are given, around 9pm. The evening weight is not standard, therefore considered the study intervention.
325348|NCT01185080|B4|Baseline|Total|Total of all reporting groups
325349|NCT01185080|B3|Baseline|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
325350|NCT01185080|B2|Baseline|Placebo|Placebo three times weekly
325351|NCT01185080|B1|Baseline|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
325363|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
325364|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
325365|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
325366|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
325367|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
325368|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
325369|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
325370|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
325371|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
325372|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
325373|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
325374|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
325375|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
325376|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
325377|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
325378|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
325379|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
325380|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
325381|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
325382|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
325383|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
325384|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
325385|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
325386|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
325387|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
325388|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
325389|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
325390|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
325391|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
325392|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
325393|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
325394|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
325395|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
325396|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
325397|NCT01185080|E3|Reported Event|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
325398|NCT01185080|E2|Reported Event|Placebo|Placebo three times weekly
325399|NCT01185080|E1|Reported Event|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
325400|NCT01185028|B1|Baseline|Nitazoxanide With Pegylated Interferon And Ribavirin|Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
325401|NCT01185028|P1|Participant Flow|Nitazoxanide With Pegylated Interferon And Ribavirin|Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
325402|NCT01185028|O1|Outcome|Nitazoxanide With Pegylated Interferon And Ribavirin|Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
325403|NCT01185028|O1|Outcome|Nitazoxanide With Pegylated Interferon And Ribavirin|Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
325404|NCT01185028|E1|Reported Event|Nitazoxanide With Pegylated Interferon And Ribavirin|Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
325405|NCT01184989|B1|Baseline|Patients Treated With Dabigatran Etexilate|Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.
325406|NCT01184989|P1|Participant Flow|Patients Treated With Dabigatran Etexilate|"Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.~142 patients were enrolled for the study, but only 112 were treated. Therefore, the number of started patients corresponds to the ones that were actually treated."
325407|NCT01184989|O1|Outcome|Patients Treated With Dabigatran Etexilate|Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.
325408|NCT01184989|O1|Outcome|Patients Treated With Dabigatran Etexilate|Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.
325409|NCT01184989|O1|Outcome|Patients Treated With Dabigatran Etexilate|Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.
325410|NCT01184989|E1|Reported Event|Patients Treated With Dabigatran Etexilate|Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.
325411|NCT01184898|B1|Baseline|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)~Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.~MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
325412|NCT01184898|P1|Participant Flow|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)~Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.~MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
325454|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
325455|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
325413|NCT01184898|O1|Outcome|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)~Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.~MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
325414|NCT01184898|O1|Outcome|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)~Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.~MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
325415|NCT01184898|O1|Outcome|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)~Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.~MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
325416|NCT01184898|O1|Outcome|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)~Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.~MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
325417|NCT01184898|E1|Reported Event|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)~Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.~MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
325418|NCT01184885|B1|Baseline|Hyper-CVAD and Sirolimus|"Hyper-CVAD and Sirolimus~Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m2 on day 6; Decadron 40mg/ day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Cycle B: Methotrexate 1000mg/m2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Rituximab (if given) will be 375 mg/m2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.~Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/ day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)"
325419|NCT01184885|P1|Participant Flow|Hyper-CVAD and Sirolimus|"Hyper-CVAD and Sirolimus~Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m2 on day 6; Decadron 40mg/ day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Cycle B: Methotrexate 1000mg/m2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Rituximab (if given) will be 375 mg/m2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.~Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/ day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)"
325420|NCT01184885|O1|Outcome|Hyper-CVAD and Sirolimus|"Hyper-CVAD and Sirolimus~Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m2 on day 6; Decadron 40mg/ day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Cycle B: Methotrexate 1000mg/m2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Rituximab (if given) will be 375 mg/m2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.~Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/ day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)"
325421|NCT01184885|O1|Outcome|Hyper-CVAD and Sirolimus|"Hyper-CVAD and Sirolimus~Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m^2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m^2 on day 6; Decadron 40mg/day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Cycle B: Methotrexate 1000mg/m^2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m^2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Rituximab (if given) will be 375 mg/m^2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.~Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)"
325422|NCT01184885|E1|Reported Event|Hyper-CVAD and Sirolimus|"Hyper-CVAD and Sirolimus~Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m2 on day 6; Decadron 40mg/ day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Cycle B: Methotrexate 1000mg/m2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Rituximab (if given) will be 375 mg/m2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.~Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/ day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)"
325423|NCT01184872|B3|Baseline|Total|Total of all reporting groups
325424|NCT01184872|B2|Baseline|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
325425|NCT01184872|B1|Baseline|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
325532|NCT01184859|E9|Reported Event|Desmopressin 50µg - Period 2|Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
325426|NCT01184872|P2|Participant Flow|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
325427|NCT01184872|P1|Participant Flow|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
325428|NCT01184872|O2|Outcome|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
325429|NCT01184872|O1|Outcome|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
325430|NCT01184872|O2|Outcome|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
325431|NCT01184872|O1|Outcome|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
325432|NCT01184872|O2|Outcome|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
325433|NCT01184872|O1|Outcome|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
325434|NCT01184872|O2|Outcome|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
325435|NCT01184872|O1|Outcome|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
325436|NCT01184872|O2|Outcome|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
325437|NCT01184872|O1|Outcome|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
325438|NCT01184872|E2|Reported Event|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
325439|NCT01184872|E1|Reported Event|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
325440|NCT01184859|B6|Baseline|Total|Total of all reporting groups
325441|NCT01184859|B5|Baseline|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
325442|NCT01184859|B4|Baseline|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
325443|NCT01184859|B3|Baseline|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
325444|NCT01184859|B2|Baseline|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
325445|NCT01184859|B1|Baseline|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
325446|NCT01184859|P5|Participant Flow|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
325447|NCT01184859|P4|Participant Flow|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
325448|NCT01184859|P3|Participant Flow|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
325449|NCT01184859|P2|Participant Flow|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
325450|NCT01184859|P1|Participant Flow|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
325451|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
325452|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
325453|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
325456|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
325457|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
325458|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
325459|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
325460|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
325461|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
325462|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
325463|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
325464|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
325465|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
325466|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
325467|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
325468|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
325469|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
325470|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
325471|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
325472|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
325473|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
325474|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
325475|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
325476|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
325477|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
325478|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
325479|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
325480|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
325481|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
325482|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
325483|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
325484|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
325485|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
325486|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
325487|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
325488|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
325489|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
325490|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
325491|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
325492|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
325493|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
325494|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
325495|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
325496|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
325497|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
325498|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
325499|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
325500|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
325501|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
325502|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
325503|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
325504|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
325505|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
325506|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
325507|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
325508|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
325509|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
325510|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
325511|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
325512|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
325513|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
325514|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
325515|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
325516|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
325517|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
325518|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
325519|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
325520|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
325521|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
325522|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
325523|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
325524|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
325525|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
325526|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
325527|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
325528|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
325529|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
325530|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
325531|NCT01184859|E10|Reported Event|Desmopressin 100µg - Period 2|Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
325636|NCT01183858|B2|Baseline|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
325533|NCT01184859|E8|Reported Event|Desmopressin 25µg - Period 2|Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
325534|NCT01184859|E7|Reported Event|Desmopressin 10µg - Period 2|Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
325535|NCT01184859|E6|Reported Event|Placebo - Period 2|Study period 2: daily doses of placebo taken before bedtime for 28 days.
325536|NCT01184859|E5|Reported Event|Desmopressin 100µg - Period 1|Study period 1: single dose of desmopressin 100µg.
325537|NCT01184859|E4|Reported Event|Desmopressin 50µg - Period 1|Study period 1: single dose of desmopressin 50µg.
325538|NCT01184859|E3|Reported Event|Desmopressin 25µg - Period 1|Study period 1: single dose of desmopressin 25µg.
325539|NCT01184859|E2|Reported Event|Desmopressin 10µg - Period 1|Study period 1: single dose of desmopressin 10µg.
325540|NCT01184859|E1|Reported Event|Placebo-Period 1|Study period 1: single dose of placebo.
325541|NCT01184846|B1|Baseline|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
325542|NCT01184846|P1|Participant Flow|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
325543|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
325544|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
325545|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
325546|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
325547|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
325548|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
325549|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
325550|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
325551|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
325552|NCT01184846|O2|Outcome|IgPro10 - After Infusion|IgG levels were determined after infusion with IgPro10.
325553|NCT01184846|O1|Outcome|IgPro10 - Before Infusion|IgG levels were determined before infusion with IgPro10.
325554|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
325555|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
325556|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
325557|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
325558|NCT01184846|E1|Reported Event|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
325559|NCT01184755|B4|Baseline|Total|Total of all reporting groups
325560|NCT01184755|B3|Baseline|Usual Care|Participants continue their usual medication and other management for their hypertension. All participants (including UC) are given a home BP monitor and asked to take their BP in morning and evening 3 days/week.
325561|NCT01184755|B2|Baseline|Relaxation Placebo Device|"Participants use modified device to pace breathing in the 13/minute range for daily practice for 8 weeks and no device thereafter~Relaxation: Participants are instructed to use the device (which paces the breath at a constant 13 breaths/minute) daily for 15 minutes (timing set automatically by device).~Sham RESPeRate"
325562|NCT01184755|B1|Baseline|Resperate Device Used for 8 Weeks|"Participants to use Resperate device to guide breathing for 8 weeks, then not used for next 8 weeks~Device-guided breathing: Participants instructed to practice daily for 15 minutes (guided and timed by the device used at home)~RESPeRate"
325563|NCT01184755|P3|Participant Flow|Usual Care|Participants continue their usual medication and other management for their hypertension. All participants (including UC) are given a home BP monitor and asked to take their BP in morning and evening 3 days/week.
325564|NCT01184755|P2|Participant Flow|Relaxation Placebo Device|"Participants use modified device to pace breathing in the 13/minute range for daily practice for 8 weeks and no device thereafter~Relaxation: Participants are instructed to use the device (which paces the breath at a constant 13 breaths/minute) daily for 15 minutes (timing set automatically by device).~Sham RESPeRate"
325637|NCT01183858|B1|Baseline|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
325565|NCT01184755|P1|Participant Flow|Resperate Device Used for 8 Weeks|"Participants to use Resperate device to guide breathing for 8 weeks, then not used for next 8 weeks~Device-guided breathing: Participants instructed to practice daily for 15 minutes (guided and timed by the device used at home)~RESPeRate"
325566|NCT01184755|O3|Outcome|Usual Care|Participants continue their usual medication and other management for their hypertension. All participants (including UC) are given a home BP monitor and asked to take their BP in morning and evening 3 days/week.
325567|NCT01184755|O2|Outcome|Relaxation Placebo Device|"Participants use modified device to pace breathing in the 13/minute range for daily practice for 8 weeks and no device thereafter~Relaxation: Participants are instructed to use the device (which paces the breath at a constant 13 breaths/minute) daily for 15 minutes (timing set automatically by device).~Sham RESPeRate"
325568|NCT01184755|O1|Outcome|Resperate Device Used for 8 Weeks|"Participants to use Resperate device to guide breathing for 8 weeks, then not used for next 8 weeks~Device-guided breathing: Participants instructed to practice daily for 15 minutes (guided and timed by the device used at home)~RESPeRate"
325569|NCT01184755|E3|Reported Event|Usual Care|Participants continue their usual medication and other management for their hypertension. All participants (including UC) are given a home BP monitor and asked to take their BP in morning and evening 3 days/week.
325570|NCT01184755|E2|Reported Event|Relaxation Placebo Device|"Participants use modified device to pace breathing in the 13/minute range for daily practice for 8 weeks and no device thereafter~Relaxation: Participants are instructed to use the device (which paces the breath at a constant 13 breaths/minute) daily for 15 minutes (timing set automatically by device).~Sham RESPeRate"
325571|NCT01184755|E1|Reported Event|Resperate Device Used for 8 Weeks|"Participants to use Resperate device to guide breathing for 8 weeks, then not used for next 8 weeks~Device-guided breathing: Participants instructed to practice daily for 15 minutes (guided and timed by the device used at home)~RESPeRate"
325572|NCT01184417|B3|Baseline|Total|Total of all reporting groups
325573|NCT01184417|B2|Baseline|Placebo Group|100 ml saline
325574|NCT01184417|B1|Baseline|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
325575|NCT01184417|P2|Participant Flow|Placebo Group|100 ml saline
325576|NCT01184417|P1|Participant Flow|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
325577|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
325578|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
325579|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
325580|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
325581|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
325582|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
325583|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
325584|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
325585|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
325586|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
325587|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
325588|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
325589|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
325590|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
325591|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
325592|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
325593|NCT01184417|E2|Reported Event|Placebo Group|100 ml saline
325594|NCT01184417|E1|Reported Event|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
325595|NCT01184118|B1|Baseline|FP 220 mcg 2 Puffs BID|"The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.~FP 220 mcg 2 puffs BID: The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care."
325596|NCT01184118|P1|Participant Flow|FP 220 mcg 2 Puffs BID|The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by 2 weeks of FP 220 mcg 2 puffs BID then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks.
325597|NCT01184118|O1|Outcome|FP 220 mcg 2 Puffs BID|The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.
325598|NCT01184118|O1|Outcome|FP 220 mcg 2 Puffs BID|The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.
325599|NCT01184118|O1|Outcome|FP 220 mcg 2 Puffs BID|The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.
325634|NCT01183975|E1|Reported Event|Patients Treated With SAGB by Solicited Teams|Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
325600|NCT01184118|E1|Reported Event|FP 220 mcg 2 Puffs BID|The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.
325601|NCT01184079|B3|Baseline|Total|Total of all reporting groups
325602|NCT01184079|B2|Baseline|6 Month Administration|"3rd dose administration at 6 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
325603|NCT01184079|B1|Baseline|12 Month Administration|"Administration of 3rd dose at 12 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
325604|NCT01184079|P2|Participant Flow|6 Month Administration|"3rd dose administration at 6 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
325605|NCT01184079|P1|Participant Flow|12 Month Administration|"Administration of 3rd dose at 12 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
325606|NCT01184079|O2|Outcome|Group With Administration of 3rd Dose at 6 Months|"Group with administration of 3rd dose at 6 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
325607|NCT01184079|O1|Outcome|Group With Administration of 3rd Dose at 12 Months|"Group with administration of 3rd dose at 12 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
325608|NCT01184079|O2|Outcome|6 Month Administration|"3rd dose administration at 6 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
325609|NCT01184079|O1|Outcome|12 Month Administration|"Administration of 3rd dose at 12 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
325610|NCT01184079|O2|Outcome|6 Month Administration|"3rd dose administration at 6 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
325611|NCT01184079|O1|Outcome|12 Month Administration|"Administration of 3rd dose at 12 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
325612|NCT01184079|E2|Reported Event|6 Month Administration|"3rd dose administration at 6 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
325613|NCT01184079|E1|Reported Event|12 Month Administration|"Administration of 3rd dose at 12 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
325614|NCT01184053|B1|Baseline|Trisenox Treatment|Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
325615|NCT01184053|P1|Participant Flow|Trisenox Treatment|Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
325616|NCT01184053|O1|Outcome|Trisenox Treatment|Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
325617|NCT01184053|O1|Outcome|Trisenox Treatment|"Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.~Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks."
325618|NCT01184053|O1|Outcome|Trisenox Treatment|Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
325619|NCT01184053|O1|Outcome|Trisenox Treatment|Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
325620|NCT01184053|E1|Reported Event|Trisenox Treatment|Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
325621|NCT01184014|B3|Baseline|Total|Total of all reporting groups
325622|NCT01184014|B2|Baseline|Control Group|the standard recommended care (Methodist Hospital Complete Insulin Orders)
325623|NCT01184014|B1|Baseline|Experimental Group|a study-specific steroid NPH dosing algorithm plus standard recommended care
325624|NCT01184014|P2|Participant Flow|Control Group|the standard recommended care (Methodist Hospital Complete Insulin Orders)
325625|NCT01184014|P1|Participant Flow|Experimental Group|a study-specific steroid NPH dosing algorithm plus standard recommended care
325626|NCT01184014|O2|Outcome|Control Group|"the standard recommended care (Methodist Hospital Complete Insulin Orders)~Complete Insulin Orders: 3-part insulin which includes background, meal-time and correction factor"
325627|NCT01184014|O1|Outcome|Experimental Group|"a study-specific steroid (NPH) dosing algorithm plus standard recommended care. The intervention is Neutral Protamine Hagedorn (NPH) insulin plus complete insulin orders (CIO).~NPH insulin plus Complete Insulin Orders: NPH dosed per study-specific algorithm which incorporates total daily dosage of steroid to determine NPH dose. Complete insulin orders include background, meal-time and correction factor."
325628|NCT01184014|E2|Reported Event|Control Group|the standard recommended care (Methodist Hospital Complete Insulin Orders)
325629|NCT01184014|E1|Reported Event|Experimental Group|a study-specific steroid NPH dosing algorithm plus standard recommended care
325630|NCT01183975|B1|Baseline|Patients Treated With SAGB by Solicited Teams|Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
325631|NCT01183975|P1|Participant Flow|Patients Treated With SAGB by Solicited Teams|Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
325632|NCT01183975|O1|Outcome|Patients Treated With SAGB by Solicited Teams|Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
325633|NCT01183975|O1|Outcome|Patients Treated With SAGB by Solicited Teams|Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
325638|NCT01183858|P2|Participant Flow|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
325639|NCT01183858|P1|Participant Flow|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
325640|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
325641|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
325642|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
325643|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
325644|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
325645|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
325646|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
325647|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
325648|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
325649|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
325650|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
325651|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
325652|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
325653|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
325654|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
325655|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
325656|NCT01183858|E2|Reported Event|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
325657|NCT01183858|E1|Reported Event|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
325658|NCT01183780|B3|Baseline|Total|Total of all reporting groups
325659|NCT01183780|B2|Baseline|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
325660|NCT01183780|B1|Baseline|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
325661|NCT01183780|P2|Participant Flow|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
325662|NCT01183780|P1|Participant Flow|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil (FOLFIRI). Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 milligrams/kilogram (mg/kg) administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
325663|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
325664|NCT01183780|O2|Outcome|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
325665|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
325666|NCT01183780|O2|Outcome|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
325767|NCT01183650|E2|Reported Event|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
325768|NCT01183650|E1|Reported Event|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
325667|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
325668|NCT01183780|O2|Outcome|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
325669|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
325670|NCT01183780|O2|Outcome|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
325671|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
325672|NCT01183780|O2|Outcome|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
325673|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
325674|NCT01183780|O2|Outcome|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
325675|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
325676|NCT01183780|E2|Reported Event|FOLFIRI + Placebo|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
325677|NCT01183780|E1|Reported Event|FOLFIRI + Ramucirumab|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
325678|NCT01183728|B1|Baseline|MSV Autologous Transplantation|"Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection~Autologous bone marrow mesenchymal stem cells (MSV): Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection."
325679|NCT01183728|P1|Participant Flow|MSV Autologous Transplantation|"Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection~Autologous bone marrow mesenchymal stem cells (MSV): Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection."
325769|NCT01183546|B1|Baseline|Wheelchair Users With ASIA A or B Spinal Cord Injury|wheelchair users with ASIA A or B spinal cord injury
325770|NCT01183546|P1|Participant Flow|Wheelchair Users With Spinal Cord Injury|wheelchair users with spinal cord injury
325904|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
325680|NCT01183728|O1|Outcome|MSV Autologous Transplantation|"Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection~Autologous bone marrow mesenchymal stem cells (MSV): Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection."
325681|NCT01183728|O1|Outcome|MSV Autologous Transplantation|"Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection~Autologous bone marrow mesenchymal stem cells (MSV): Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection."
325682|NCT01183728|E1|Reported Event|MSV Autologous Transplantation|"Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection~Autologous bone marrow mesenchymal stem cells (MSV): Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection."
325683|NCT01183689|B4|Baseline|Total|Total of all reporting groups
325684|NCT01183689|B3|Baseline|Self-regulation With Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes."
325685|NCT01183689|B2|Baseline|Self-regulation With Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes."
325686|NCT01183689|B1|Baseline|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
325687|NCT01183689|P3|Participant Flow|Self-regulation With Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes."
325688|NCT01183689|P2|Participant Flow|Self-regulation With Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes."
325689|NCT01183689|P1|Participant Flow|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
325690|NCT01183689|O3|Outcome|Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.~Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.~Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes"
325745|NCT01183689|O2|Outcome|Self-regulation With Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes."
325691|NCT01183689|O2|Outcome|Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.~Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.~Exercise: At the start of the program, participants will be given a pedometer and asked"
325692|NCT01183689|O1|Outcome|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
325693|NCT01183689|O3|Outcome|Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.~Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.~Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes"
325694|NCT01183689|O2|Outcome|Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.~Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.~Exercise: At the start of the program, participants will be given a pedometer and asked"
325695|NCT01183689|O1|Outcome|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
325696|NCT01183689|O3|Outcome|Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.~Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.~Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes"
325697|NCT01183689|O2|Outcome|Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.~Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.~Exercise: At the start of the program, participants will be given a pedometer and asked"
325698|NCT01183689|O1|Outcome|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
325699|NCT01183689|O3|Outcome|Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.~Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.~Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes"
325700|NCT01183689|O2|Outcome|Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.~Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.~Exercise: At the start of the program, participants will be given a pedometer and asked"
325701|NCT01183689|O1|Outcome|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
325702|NCT01183689|O3|Outcome|Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.~Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.~Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes"
325703|NCT01183689|O2|Outcome|Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.~Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.~Exercise: At the start of the program, participants will be given a pedometer and asked"
325704|NCT01183689|O1|Outcome|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
325705|NCT01183689|O3|Outcome|Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.~Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.~Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes"
325706|NCT01183689|O2|Outcome|Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.~Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.~Exercise: At the start of the program, participants will be given a pedometer and asked"
325707|NCT01183689|O1|Outcome|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
325708|NCT01183689|O3|Outcome|Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.~Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.~Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes"
325709|NCT01183689|O2|Outcome|Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.~Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.~Exercise: At the start of the program, participants will be given a pedometer and asked"
325710|NCT01183689|O1|Outcome|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
325711|NCT01183689|O3|Outcome|Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.~Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.~Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes"
325712|NCT01183689|O2|Outcome|Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.~Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.~Exercise: At the start of the program, participants will be given a pedometer and asked"
325713|NCT01183689|O1|Outcome|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
325714|NCT01183689|O3|Outcome|Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.~Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.~Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes"
325715|NCT01183689|O2|Outcome|Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.~Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.~Exercise: At the start of the program, participants will be given a pedometer and asked"
325716|NCT01183689|O1|Outcome|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
325717|NCT01183689|O3|Outcome|Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.~Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.~Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes"
325718|NCT01183689|O2|Outcome|Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.~Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.~Exercise: At the start of the program, participants will be given a pedometer and asked"
325719|NCT01183689|O1|Outcome|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
325720|NCT01183689|O3|Outcome|Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.~Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.~Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes"
325721|NCT01183689|O2|Outcome|Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.~Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.~Exercise: At the start of the program, participants will be given a pedometer and asked"
325722|NCT01183689|O1|Outcome|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
325723|NCT01183689|O3|Outcome|Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.~Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.~Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes"
325724|NCT01183689|O2|Outcome|Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.~Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.~Exercise: At the start of the program, participants will be given a pedometer and asked"
325725|NCT01183689|O1|Outcome|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
325726|NCT01183689|O3|Outcome|Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.~Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.~Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes"
325727|NCT01183689|O2|Outcome|Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.~Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.~Exercise: At the start of the program, participants will be given a pedometer and asked"
325728|NCT01183689|O1|Outcome|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
325729|NCT01183689|O3|Outcome|Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.~Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.~Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes"
325730|NCT01183689|O2|Outcome|Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.~Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.~Exercise: At the start of the program, participants will be given a pedometer and asked"
325731|NCT01183689|O1|Outcome|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
325732|NCT01183689|O3|Outcome|Self-regulation With Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes."
325733|NCT01183689|O2|Outcome|Self-regulation With Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes."
325734|NCT01183689|O1|Outcome|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
325735|NCT01183689|O3|Outcome|Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.~Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.~Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes"
325746|NCT01183689|O1|Outcome|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
325736|NCT01183689|O2|Outcome|Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.~Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.~Exercise: At the start of the program, participants will be given a pedometer and asked"
325737|NCT01183689|O1|Outcome|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
325738|NCT01183689|O3|Outcome|Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.~Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.~Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes"
325739|NCT01183689|O2|Outcome|Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.~Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.~Exercise: At the start of the program, participants will be given a pedometer and asked"
325740|NCT01183689|O1|Outcome|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
325741|NCT01183689|O3|Outcome|Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Large Behavior Changes: The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.~Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.~Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes"
325742|NCT01183689|O2|Outcome|Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Small Behavior Changes: The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.~Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.~Exercise: At the start of the program, participants will be given a pedometer and asked"
325743|NCT01183689|O1|Outcome|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
325744|NCT01183689|O3|Outcome|Self-regulation With Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes."
325765|NCT01183650|O2|Outcome|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
325766|NCT01183650|O1|Outcome|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
325747|NCT01183689|O3|Outcome|Self-regulation With Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes."
325748|NCT01183689|O2|Outcome|Self-regulation With Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes."
325749|NCT01183689|O1|Outcome|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
325750|NCT01183689|O3|Outcome|Self-regulation With Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes."
325751|NCT01183689|O2|Outcome|Self-regulation With Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes."
325752|NCT01183689|O1|Outcome|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
325753|NCT01183689|E3|Reported Event|Self-regulation With Large Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).~Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes."
325754|NCT01183689|E2|Reported Event|Self-regulation With Small Behavior Changes|"Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).~Self-regulation theory: Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes."
325755|NCT01183689|E1|Reported Event|Control Group|"Self-Guided Behavior Changes. This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating."
325756|NCT01183650|B3|Baseline|Total|Total of all reporting groups
325757|NCT01183650|B2|Baseline|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
325758|NCT01183650|B1|Baseline|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
325759|NCT01183650|P2|Participant Flow|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
325760|NCT01183650|P1|Participant Flow|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
325761|NCT01183650|O2|Outcome|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
325762|NCT01183650|O1|Outcome|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
325763|NCT01183650|O2|Outcome|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
325764|NCT01183650|O1|Outcome|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
325771|NCT01183546|O2|Outcome|Followup Transfer Testing|Wheelchair users with spinal cord injury who met the criteria for transfer training at Baseline and returned four weeks later for transfer training and retesting.
325772|NCT01183546|O1|Outcome|Baseline Transfer Testing|Wheelchair Users with Spinal Cord Injury who met criteria for transfer training
325773|NCT01183546|O2|Outcome|Followup Transfer Testing|Wheelchair users with spinal cord injury who met the criteria for transfer training at Baseline and returned four weeks later for transfer training and retesting.
325774|NCT01183546|O1|Outcome|Baseline Transfer Testing|Wheelchair Users with Spinal Cord Injury who met criteria for transfer training
325775|NCT01183546|E1|Reported Event|Wheelchair Users With ASIA A or B Spinal Cord Injury|wheelchair users with ASIA A or B spinal cord injury
325776|NCT01183533|B1|Baseline|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.~Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
325777|NCT01183533|P1|Participant Flow|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.~Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
325778|NCT01183533|O1|Outcome|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.~Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
325779|NCT01183533|O1|Outcome|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.~Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
325780|NCT01183533|O1|Outcome|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.~Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
325781|NCT01183533|E1|Reported Event|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.~Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
325782|NCT01183481|B1|Baseline|Aprepitant and Granisetron|Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
325783|NCT01183481|P1|Participant Flow|Aprepitant and Granisetron|Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
325784|NCT01183481|O1|Outcome|Aprepitant and Granisetron|"Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the Palliative radiation therapy.~Aprepitant: Patients will be given a single dose of Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.~Palliative radiation therapy: Moderately emetogenic palliative radiation therapy (RT) will be administered to all patients on the study.~Granisetron: Patients will be given a single dose of both Granisetron 2 mg orally on Day 0 (at least one hour before on the day of RT)."
325785|NCT01183481|O1|Outcome|Aprepitant and Granisetron|"Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the Palliative radiation therapy.~Aprepitant: Patients will be given a single dose of Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.~Palliative radiation therapy: Moderately emetogenic palliative radiation therapy (RT) will be administered to all patients on the study.~Granisetron: Patients will be given a single dose of both Granisetron 2 mg orally on Day 0 (at least one hour before on the day of RT)."
325786|NCT01183481|O1|Outcome|Aprepitant and Granisetron|"Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the Palliative radiation therapy.~Aprepitant: Patients will be given a single dose of Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.~Palliative radiation therapy: Moderately emetogenic palliative radiation therapy (RT) will be administered to all patients on the study.~Granisetron: Patients will be given a single dose of both Granisetron 2 mg orally on Day 0 (at least one hour before on the day of RT)."
325787|NCT01183481|O1|Outcome|Aprepitant and Granisetron|"Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the Palliative radiation therapy.~Aprepitant: Patients will be given a single dose of Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.~Palliative radiation therapy: Moderately emetogenic palliative radiation therapy (RT) will be administered to all patients on the study.~Granisetron: Patients will be given a single dose of both Granisetron 2 mg orally on Day 0 (at least one hour before on the day of RT)."
325788|NCT01183481|O1|Outcome|Aprepitant and Granisetron|Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
325789|NCT01183481|E1|Reported Event|Aprepitant and Granisetron|Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
325790|NCT01183468|B5|Baseline|Total|Total of all reporting groups
325791|NCT01183468|B4|Baseline|Part 1b (Aralast NP)-Subjects 8-17 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.~Aralast NP 90 mg dose: - 90 mg/kg/week~Aralast NP 180 mg dose: - 180 mg/kg/week"
325792|NCT01183468|B3|Baseline|Part 1b (Aralast NP)-Subjects Aged 18-35 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.~Aralast NP 90 mg dose: - 90 mg/kg/week~Aralast NP 180 mg dose: - 180 mg/kg/week"
325793|NCT01183468|B2|Baseline|Part 1a (Aralast NP)-Subjects 8-15 Yrs|Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
325794|NCT01183468|B1|Baseline|Part 1a(Aralast NP)-Subjects Aged 16-35 Yrs|Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by intravenous (IV) infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
325795|NCT01183468|P4|Participant Flow|Part 1b (Aralast NP)-Subjects 8-17 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.~Aralast NP 90 mg dose: - 90 mg/kg/week~Aralast NP 180 mg dose: - 180 mg/kg/week"
325796|NCT01183468|P3|Participant Flow|Part 1b (Aralast NP)-Subjects Aged 18-35 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.~Aralast NP 90 mg dose: - 90 mg/kg/week~Aralast NP 180 mg dose: - 180 mg/kg/week"
325797|NCT01183468|P2|Participant Flow|Part 1a (Aralast NP)-Subjects 8-15 Yrs|Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
325798|NCT01183468|P1|Participant Flow|Part 1a(Aralast NP)-Subjects Aged 16-35 Yrs|Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by intravenous (IV) infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
325799|NCT01183468|O4|Outcome|Part 1b (Aralast NP)-Subjects 8-17 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.~Aralast NP 90 mg dose: - 90 mg/kg/week~Aralast NP 180 mg dose: - 180 mg/kg/week"
325800|NCT01183468|O3|Outcome|Part 1b (Aralast NP)-Subjects Aged 18-35 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.~Aralast NP 90 mg dose: - 90 mg/kg/week~Aralast NP 180 mg dose: - 180 mg/kg/week"
325801|NCT01183468|O2|Outcome|Part 1a (Aralast NP)-Subjects 8-15 Yrs|Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
325802|NCT01183468|O1|Outcome|Part 1a(Aralast NP)-Subjects Aged 16-35 Yrs|Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by intravenous (IV) infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
325803|NCT01183468|E2|Reported Event|Subjects Aged 8 – 15 Years|Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
325804|NCT01183468|E1|Reported Event|Subjects Aged 16 – 35 Years|Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
325805|NCT01183390|B3|Baseline|Total|Total of all reporting groups
325806|NCT01183390|B2|Baseline|Arimidex® (Reference) First|1 mg Arimidex® Tablets reference product dosed in first period followed by 1 mg Anastrazole Tablets test product dosed in the second period.
325807|NCT01183390|B1|Baseline|Anastrazole (Test) First|1 mg Anastrozole Tablets test product dosed in first period followed by 1 mg Arimidex® Tablets reference product dosed in the second period.
325808|NCT01183390|P2|Participant Flow|Arimidex® (Reference) First|1 mg Arimidex® Tablets reference product dosed in first period followed by 1 mg Anastrazole Tablets test product dosed in the second period.
325809|NCT01183390|P1|Participant Flow|Anastrazole (Test) First|1 mg Anastrozole Tablets test product dosed in first period followed by 1 mg Arimidex® Tablets reference product dosed in the second period.
325810|NCT01183390|O2|Outcome|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
325811|NCT01183390|O1|Outcome|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period.
325812|NCT01183390|O2|Outcome|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
325813|NCT01183390|O1|Outcome|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period.
325814|NCT01183390|E2|Reported Event|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
325815|NCT01183390|E1|Reported Event|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period
325816|NCT01183312|B3|Baseline|Total|Total of all reporting groups
325817|NCT01183312|B2|Baseline|Flumazenil First, Then Placebo|Sublingual flumazenil during the first intervention day and placebo during the second intervention day (after washout period).
325818|NCT01183312|B1|Baseline|Placebo First, Then Flumazenil|Placebo during the first intervention day and sublingual flumazenil during the second intervention day (after washout period).
325819|NCT01183312|P2|Participant Flow|Flumazenil First, Then Placebo|Flumazenil administered sublingually three times during the first study day (as 12 mg, then 6 mg, then 6 mg, at approximately 3 hour intervals), followed by a washout of at least 7 days, then placebo administered sublingually three times on the second study day.
325820|NCT01183312|P1|Participant Flow|Placebo First, Then Flumazenil|Placebo administered sublingually three times during the first study day, followed by a washout of at least 7 days, then flumazenil administered sublingually three times during the second study day.
325821|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
325822|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
325823|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
325824|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
325825|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
325826|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
325827|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
325828|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
325829|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
325830|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
325831|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
325832|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
325833|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
325834|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
325835|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
325836|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
325837|NCT01183312|E2|Reported Event|Sublingual Flumazenil|
325838|NCT01183312|E1|Reported Event|Placebo|
325839|NCT01183260|B3|Baseline|Total|Total of all reporting groups
325840|NCT01183260|B2|Baseline|Zimmer Modular Cup|Zimmer Modular Cup: Revision of the acetabular cup
325841|NCT01183260|B1|Baseline|Zimmer Trabecular Metal Acetabular Cup|Zimmer Trabecular Metal Revision Cup: Revision of the acetabular cup
325842|NCT01183260|P2|Participant Flow|Zimmer Modular Cup|Zimmer Modular Cup: Revision of the acetabular cup
325843|NCT01183260|P1|Participant Flow|Zimmer Trabecular Metal Acetabular Cup|Zimmer Trabecular Metal Revision Cup: Revision of the acetabular cup
325844|NCT01183260|O2|Outcome|Zimmer Modular Cup|Zimmer Modular Cup: Revision of the acetabular cup
325845|NCT01183260|O1|Outcome|Zimmer Trabecular Metal Acetabular Cup|Zimmer Trabecular Metal Revision Cup: Revision of the acetabular cup
325846|NCT01183260|O2|Outcome|Zimmer Modular Cup|Zimmer Modular Cup: Revision of the acetabular cup
325847|NCT01183260|O1|Outcome|Zimmer Trabecular Metal Acetabular Cup|Zimmer Trabecular Metal Revision Cup: Revision of the acetabular cup
325848|NCT01183260|E2|Reported Event|Zimmer Modular Cup|Zimmer Modular Cup: Revision of the acetabular cup
325849|NCT01183260|E1|Reported Event|Zimmer Trabecular Metal Acetabular Cup|Zimmer Trabecular Metal Revision Cup: Revision of the acetabular cup
325850|NCT01183234|B3|Baseline|Total|Total of all reporting groups
325851|NCT01183234|B2|Baseline|Metadate CD First, Then Equasym XL|Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Equasym XL (SPD544, Methylphenidate HCl given as two 30 mg capsules)
325852|NCT01183234|B1|Baseline|Equasym XL First, Then Metadate CD|Subjects received a single oral dose of 60 mg of Equasym XL (SPD544, Methylphenidate HCl given as two 30 mg capsules), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
325853|NCT01183234|P2|Participant Flow|Metadate CD First, Then Equasym XL|Subjects received a single oral dose of 60 mg of Metadate CD (given as one 60 mg capsule), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Equasym XL (given as two 30 mg capsules)
325903|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
325854|NCT01183234|P1|Participant Flow|Equasym XL (SPD544) First, Then Metadate CD|Subjects received a single oral dose of 60 mg of Equasym XL (given as two 30 mg capsules), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Metadate CD (given as one 60 mg capsule)
325855|NCT01183234|O2|Outcome|Metadate CD|Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
325856|NCT01183234|O1|Outcome|Equasym XL|Subjects received a single oral dose of 60 mg of Equasym XL (Methylphenidate HCl given as two 30 mg capsules)
325857|NCT01183234|O2|Outcome|Metadate CD|Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
325858|NCT01183234|O1|Outcome|Equasym XL|Subjects received a single oral dose of 60 mg of Equasym XL (Methylphenidate HCl given as two 30 mg capsules)
325859|NCT01183234|O2|Outcome|Metadate CD|Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
325860|NCT01183234|O1|Outcome|Equasym XL|Subjects received a single oral dose of 60 mg of Equasym XL (Methylphenidate HCl given as two 30 mg capsules)
325861|NCT01183234|E2|Reported Event|Metadate CD|Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
325862|NCT01183234|E1|Reported Event|Equasym XL|Subjects received a single oral dose of 60 mg of Equasym XL (Methylphenidate HCl given as two 30 mg capsules)
325863|NCT01183169|B5|Baseline|Total|Total of all reporting groups
325864|NCT01183169|B4|Baseline|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
325865|NCT01183169|B3|Baseline|Treatment C|Treatment C1 + Treatment C2. ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
325866|NCT01183169|B2|Baseline|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
325867|NCT01183169|B1|Baseline|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
325868|NCT01183169|P7|Participant Flow|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
325869|NCT01183169|P6|Participant Flow|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
325870|NCT01183169|P5|Participant Flow|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
325871|NCT01183169|P4|Participant Flow|Treatment C2|Treatment C subset C2: ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV 400 mg twice daily (BID) with PEG and RBV.
325872|NCT01183169|P3|Participant Flow|Treatment C1|Treatment C subset C1: ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR: hepatitis C virus (HCV) ribonucleic acid (RNA) <LOQ after 12 weeks of treatment) could switch to active ALV 600 mg QD with PEG and RBV.
325873|NCT01183169|P2|Participant Flow|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
325874|NCT01183169|P1|Participant Flow|Treatment A|Alisporivir (ALV; DEB025) 600 mg once daily (QD) with peginterferon alfa-2a (PEG) and ribavirin (RBV) for up to 48 weeks.
325875|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
325876|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
325877|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
325878|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
325879|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
325880|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
325881|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
325882|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
325883|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
325884|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
325885|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
325886|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
325887|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
325888|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
325889|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
325890|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
325891|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
325892|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
325893|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
325894|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
325895|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
325896|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
325897|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
325898|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
325899|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
325900|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
325901|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
325902|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
325905|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
325906|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
325907|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
325908|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
325909|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
325910|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
325911|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
325912|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
325913|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
325914|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
325915|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
325916|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
325917|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
325918|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
325919|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
325920|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
325921|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
325922|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
325923|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
325924|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
325925|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
325926|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
325927|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
325928|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
325929|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
325930|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
325931|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
325932|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
325933|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
325934|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
325935|NCT01183169|E10|Reported Event|Treatment D: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 400 mg BID with PEG and RBV for up to 48 weeks.
325936|NCT01183169|E9|Reported Event|Treatment C2: Post-treatment AEs|AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 400 mg BID post-switch) with PEG and RBV for up to 48 weeks.
325937|NCT01183169|E8|Reported Event|Treatment C1: Post-treatment AEs|AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 600 mg QD post-switch) with PEG and RBV for up to 48 weeks.
325938|NCT01183169|E7|Reported Event|Treatment B: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 800 mg QD with PEG and RBV for up to 48 weeks.
325939|NCT01183169|E6|Reported Event|Treatment A: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 600 mg QD with PEG and RBV for up to 48 weeks.
325940|NCT01183169|E5|Reported Event|Treatment D: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV 400 mg BID with PEG and RBV for up to 48 weeks.
325941|NCT01183169|E4|Reported Event|Treatment C2: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 400 mg BID post-switch) with PEG and RBV for up to 48 weeks.
325942|NCT01183169|E3|Reported Event|Treatment C1: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 600 mg QD post-switch) with PEG and RBV for up to 48 weeks.
325943|NCT01183169|E2|Reported Event|Treatment B: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV 800 mg QD with PEG and RBV for up to 48 weeks.
325944|NCT01183169|E1|Reported Event|Treatment A: On-treatment AEs|Adverse events (AEs) occurring while on treatment in participants receiving ALV 600 mg QD with PEG and RBV for up to 48 weeks.
325945|NCT01183143|B1|Baseline|GONAL-f®|GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed.
325946|NCT01183143|P1|Participant Flow|GONAL-f®|GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed.
325970|NCT01183104|O2|Outcome|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
325971|NCT01183104|O1|Outcome|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
325947|NCT01183143|O1|Outcome|GONAL-f®|GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed.
325948|NCT01183143|O1|Outcome|GONAL-f®|GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed.
325949|NCT01183143|O1|Outcome|GONAL-f®|GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed.
325950|NCT01183143|O1|Outcome|GONAL-f®|GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed.
325951|NCT01183143|O1|Outcome|GONAL-f®|GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed.
325952|NCT01183143|O1|Outcome|GONAL-f®|GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed.
325953|NCT01183143|O1|Outcome|GONAL-f®|GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed.
325954|NCT01183143|O1|Outcome|GONAL-f®|GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed.
325955|NCT01183143|O1|Outcome|GONAL-f®|GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed.
325956|NCT01183143|O1|Outcome|GONAL-f®|GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed.
325957|NCT01183143|O1|Outcome|GONAL-f®|GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed.
325958|NCT01183143|E1|Reported Event|GONAL-f®|GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed.
325959|NCT01183104|B3|Baseline|Total|Total of all reporting groups
325960|NCT01183104|B2|Baseline|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
325961|NCT01183104|B1|Baseline|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
325962|NCT01183104|P2|Participant Flow|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
325963|NCT01183104|P1|Participant Flow|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; estimate glomerular filtration rate (eGFR) 30=< <50).
325964|NCT01183104|O2|Outcome|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
325965|NCT01183104|O1|Outcome|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
325966|NCT01183104|O2|Outcome|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
325967|NCT01183104|O1|Outcome|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
325968|NCT01183104|O2|Outcome|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
325969|NCT01183104|O1|Outcome|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
325972|NCT01183104|O2|Outcome|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
325973|NCT01183104|O1|Outcome|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
325974|NCT01183104|O2|Outcome|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
325975|NCT01183104|O1|Outcome|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
325976|NCT01183104|E2|Reported Event|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
325977|NCT01183104|E1|Reported Event|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
325978|NCT01183065|B1|Baseline|Pralatrexate and Vitamin Supplementation|"This will be an open-label, single arm, Simon optimal two-stage design phase II study.~Pralatrexate With Vitamin B12 and Folic Acid: Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate."
325979|NCT01183065|P1|Participant Flow|Pralatrexate and Vitamin Supplementation|"This will be an open-label, single arm, Simon optimal two-stage design phase II study.~Pralatrexate With Vitamin B12 and Folic Acid: Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate."
325980|NCT01183065|O1|Outcome|Pralatrexate and Vitamin Supplementation|"This will be an open-label, single arm, Simon optimal two-stage design phase II study.~Pralatrexate With Vitamin B12 and Folic Acid: Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate."
325981|NCT01183065|E1|Reported Event|Pralatrexate and Vitamin Supplementation|"This will be an open-label, single arm, Simon optimal two-stage design phase II study.~Pralatrexate With Vitamin B12 and Folic Acid: Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate."
325982|NCT01183013|B8|Baseline|Total|Total of all reporting groups
325983|NCT01183013|B7|Baseline|Lina5Pio45/Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 6 weeks and linagliptin 5mg + pioglitazone 45mg FDC for 24 weeks followed by linagliptin 5mg + pioglitazone 45mg FDC for up to 54 weeks.
325984|NCT01183013|B6|Baseline|Lina5Pio30/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
325985|NCT01183013|B5|Baseline|Lina5Pio15/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by a blinded trial period on linagliptin 5mg + pioglitazone 30mg FDC
325986|NCT01183013|B4|Baseline|Lina5/Lina5|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
325987|NCT01183013|B3|Baseline|Pio45/Pio45|Participants treated with pioglitazone 30 mg for 6 weeks and then were titrated up to pioglitazone 45mg for 24 weeks followed by pioglitazone 45mg for up to 54 weeks.
325988|NCT01183013|B2|Baseline|Pio30/Pio30|Participants treated with pioglitazone 30mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
325989|NCT01183013|B1|Baseline|Pio15/Pio30|Participants treated with pioglitazone 15mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
325990|NCT01183013|P7|Participant Flow|Lina5Pio45/Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 6 weeks and linagliptin 5mg + pioglitazone 45mg FDC for 24 weeks followed by linagliptin 5mg + pioglitazone 45mg FDC for up to 54 weeks.
325991|NCT01183013|P6|Participant Flow|Lina5Pio30/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
325992|NCT01183013|P5|Participant Flow|Lina5Pio15/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
325993|NCT01183013|P4|Participant Flow|Lina5/Lina5|Participants treated with linagliptin 5mg once daily for 30 weeks followed by linagliptin 5mg once daily for up to 54 weeks.
325994|NCT01183013|P3|Participant Flow|Pio45/Pio45|Participants treated with pioglitazone 30 mg for 6 weeks and then were titrated up to pioglitazone 45mg for 24 weeks followed by pioglitazone 45mg for up to 54 weeks.
325995|NCT01183013|P2|Participant Flow|Pio30/Pio30|Participants treated with pioglitazone 30mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
325996|NCT01183013|P1|Participant Flow|Pio15/Pio30|Participants treated with pioglitazone 15mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
325997|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
325998|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
325999|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
326000|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
326001|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
326002|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
326003|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
326004|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
326005|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
326006|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
326007|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
326008|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
326009|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
326010|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
326011|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
326012|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
326013|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
326014|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
326015|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
326016|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
326017|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
326018|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
326019|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
326020|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
326021|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
326022|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
326023|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
326024|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
326025|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
326026|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
326027|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
326028|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
326029|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
326030|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
326031|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
326032|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
326033|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
326034|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
326035|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
326036|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
326037|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
326038|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
326039|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
326040|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
326483|NCT01181492|B3|Baseline|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
326041|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
326042|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
326043|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
326044|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
326045|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
326046|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
326047|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
326048|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
326049|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
326050|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks
326051|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
326052|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
326053|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
326054|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
326055|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
326056|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
326057|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks
326058|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
326059|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
326060|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
326061|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
326062|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
326063|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
326064|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
326065|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
326066|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
326067|NCT01183013|E7|Reported Event|Lina5Pio45/Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 6 weeks and linagliptin 5mg + pioglitazone 45mg FDC for 24 weeks followed by linagliptin 5mg + pioglitazone 45mg FDC for up to 54 weeks.
326068|NCT01183013|E6|Reported Event|Lina5Pio30/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
326069|NCT01183013|E5|Reported Event|Lina5Pio15/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
326070|NCT01183013|E4|Reported Event|Lina5/Lina5|Participants treated with linagliptin 5mg once daily for 30 weeks followed by linagliptin 5mg once daily for up to 54 weeks.
326071|NCT01183013|E3|Reported Event|Pio45/Pio45|Participants treated with pioglitazone 30 mg for 6 weeks and then were titrated up to pioglitazone 45mg for 24 weeks followed by pioglitazone 45mg for up to 54 weeks.
326072|NCT01183013|E2|Reported Event|Pio30/Pio30|Participants treated with pioglitazone 30mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
326073|NCT01183013|E1|Reported Event|Pio15/Pio30|Participants treated with pioglitazone 15mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
326074|NCT01182805|B1|Baseline|Single Arm Study.|
326075|NCT01182805|P1|Participant Flow|All Study Participants|All study participants underwent measurement of Diastolic Circumferential Strain Rate during Isovolumic Relaxation as well as measurement of E-prime by tissue Doppler. They also all had evaluation of their diastolic function by the combination of their mitral inflow pattern and invasive measure of left ventricular end-diastolic pressure.
326076|NCT01182805|O3|Outcome|Grade 2 Diastolic Dysfunction|These were the subjects deemed to have Grade 2 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP > 15 mm Hg).
326077|NCT01182805|O2|Outcome|Grade 1 Diastolic Dysfunction|These were the subjects deemed to have Grade 1 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A < 1.0).
326078|NCT01182805|O1|Outcome|Normal Diastolic Function|These were the subjects deemed to have normal diastolic function using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP <= 15 mm Hg).
326079|NCT01182805|O3|Outcome|Grade 2 Diastolic Dysfunction|These were the subjects deemed to have Grade 2 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP > 15 mm Hg).
326080|NCT01182805|O2|Outcome|Grade 1 Diastolic Dysfunction|These were the subjects deemed to have Grade 1 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A < 1.0).
326081|NCT01182805|O1|Outcome|Normal Diastolic Function|These were the subjects deemed to have normal diastolic function using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP <= 15 mm Hg).
326082|NCT01182805|E1|Reported Event|Single Arm Study.|
326083|NCT01182727|B1|Baseline|Salsalate|Salsalate will be administered in two divided doses of 2grams in the morning and 2 grams in the evening. Salsalate will be administered for 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until a tolerated dose or a minimum dose of 2 grams per day is reached.
326084|NCT01182727|P1|Participant Flow|Salsalate|Salsalate will be administered in two divided doses of 2grams in the morning and 2 grams in the evening. Salsalate will be administered for 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until a tolerated dose or a minimum dose of 2 grams per day is reached.
326085|NCT01182727|O1|Outcome|Salsalate|Salsalate will be administered in two divided doses of 2grams in the morning and 2 grams in the evening. Salsalate will be administered for 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until a tolerated dose or a minimum dose of 2 grams per day is reached.
326086|NCT01182727|E1|Reported Event|Salsalate|Salsalate will be administered in two divided doses of 2grams in the morning and 2 grams in the evening. Salsalate will be administered for 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until a tolerated dose or a minimum dose of 2 grams per day is reached.
326087|NCT01182675|B3|Baseline|Total|Total of all reporting groups
326088|NCT01182675|B2|Baseline|T-cell Graft Resistant SCID|"Patients with SCID with NK+ phenotype with HLA-mismatched donor~Transplant Conditioning with Mobilization and Alemtuzumab: Day -7: Alemtuzumab 0.3 mg test dose then 0.3 mg/kg IV; Day -6: Alemtuzumab 0.3 mg/kg IV; Day -5: Alemtuzumab 0.3 mg/kg IV; Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0: Transplant"
326089|NCT01182675|B1|Baseline|T-cell Graft Permissive SCID|"Patients with SCID with:~i. NK- phenotype; ii. NK+ phenotype with 10/10 HLA-matched relative or unrelated donor; or iii. NK+ phenotype with maternal engraftment by STR analysis and undergoing haplocompatible HSCT from maternal donor~Transplant Conditioning with Mobilization Only: Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0 Transplant"
326090|NCT01182675|P2|Participant Flow|T-cell Graft Resistant SCID|"Patients with SCID with NK+ phenotype with HLA-mismatched donor~Transplant Conditioning with Mobilization and Alemtuzumab: Day -7: Alemtuzumab 0.3 mg test dose then 0.3 mg/kg IV; Day -6: Alemtuzumab 0.3 mg/kg IV; Day -5: Alemtuzumab 0.3 mg/kg IV; Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0: Transplant"
326091|NCT01182675|P1|Participant Flow|T-cell Graft Permissive SCID|"Patients with SCID with:~i. NK- phenotype; ii. NK+ phenotype with 10/10 HLA-matched relative or unrelated donor; or iii. NK+ phenotype with maternal engraftment by STR analysis and undergoing haplocompatible HSCT from maternal donor~Transplant Conditioning with Mobilization Only: Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0 Transplant"
326092|NCT01182675|O2|Outcome|T-cell Graft Resistant SCID|"Patients with SCID with NK+ phenotype with HLA-mismatched donor~Transplant Conditioning with Mobilization and Alemtuzumab: Day -7: Alemtuzumab 0.3 mg test dose then 0.3 mg/kg IV; Day -6: Alemtuzumab 0.3 mg/kg IV; Day -5: Alemtuzumab 0.3 mg/kg IV; Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0: Transplant"
326093|NCT01182675|O1|Outcome|T-cell Graft Permissive SCID|"Patients with SCID with:~i. NK- phenotype; ii. NK+ phenotype with 10/10 HLA-matched relative or unrelated donor; or iii. NK+ phenotype with maternal engraftment by STR analysis and undergoing haplocompatible HSCT from maternal donor~Transplant Conditioning with Mobilization Only: Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0 Transplant"
326094|NCT01182675|E2|Reported Event|T-cell Graft Resistant SCID|"Patients with SCID with NK+ phenotype with HLA-mismatched donor~Transplant Conditioning with Mobilization and Alemtuzumab: Day -7: Alemtuzumab 0.3 mg test dose then 0.3 mg/kg IV; Day -6: Alemtuzumab 0.3 mg/kg IV; Day -5: Alemtuzumab 0.3 mg/kg IV; Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0: Transplant"
326095|NCT01182675|E1|Reported Event|T-cell Graft Permissive SCID|"Patients with SCID with:~i. NK- phenotype; ii. NK+ phenotype with 10/10 HLA-matched relative or unrelated donor; or iii. NK+ phenotype with maternal engraftment by STR analysis and undergoing haplocompatible HSCT from maternal donor~Transplant Conditioning with Mobilization Only: Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0 Transplant"
326096|NCT01182610|B1|Baseline|Treatment Group|"Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36~Treatment group : Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36"
326097|NCT01182610|P1|Participant Flow|Treatment Group|"Treatment group : Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36"
326098|NCT01182610|O1|Outcome|Treatment Group|"Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36"
326099|NCT01182610|O1|Outcome|Treatment Group|"Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36"
326100|NCT01182610|O1|Outcome|Treatment Group|"Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36"
326101|NCT01182610|O1|Outcome|Treatment Group|"Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36"
326102|NCT01182610|O1|Outcome|Treatment Group|"Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36"
326103|NCT01182610|E1|Reported Event|Treatment Group: Panitumumab, Paclitaxel, Carboplatin and 5FU|Panitumumab 9mg/kg on Days 1, 22, and 43; Paclitaxel 200mg/m2 on Days 1 and 22; Carboplatin AUC=6 on Days 1 and 22; 5FU 225mg/m2/day on Days 1-15 and 22-36
326104|NCT01182493|B3|Baseline|Total|Total of all reporting groups
326105|NCT01182493|B2|Baseline|Insulin Treatment With MDI|patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
326106|NCT01182493|B1|Baseline|Insulin Pump Treatment|"Patients will get an insulin pump~Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient"
326107|NCT01182493|P2|Participant Flow|Insulin Treatment With MDI|patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
326108|NCT01182493|P1|Participant Flow|Insulin Pump Treatment|"Patients will get an insulin pump~Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient."
326109|NCT01182493|O2|Outcome|Insulin Treatment With MDI|patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
326110|NCT01182493|O1|Outcome|Insulin Pump Treatment|"Patients will get an insulin pump~Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient."
326111|NCT01182493|O2|Outcome|Insulin Treatment With MDI|patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
326112|NCT01182493|O1|Outcome|Insulin Pump Treatment|"Patients will get an insulin pump~Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient."
326113|NCT01182493|O2|Outcome|Insulin Treatment With MDI|patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
326114|NCT01182493|O1|Outcome|Insulin Pump Treatment|"Patients will get an insulin pump~Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient."
326115|NCT01182493|O2|Outcome|Insulin Treatment With MDI|patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
326116|NCT01182493|O1|Outcome|Insulin Pump Treatment|"Patients will get an insulin pump~Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient."
326117|NCT01182493|O2|Outcome|Insulin Treatment With MDI|patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
326118|NCT01182493|O1|Outcome|Insulin Pump Treatment|"Patients will get an insulin pump~Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient."
326119|NCT01182493|O2|Outcome|Insulin Treatment With MDI|patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
326120|NCT01182493|O1|Outcome|Insulin Pump Treatment|"Patients will get an insulin pump~Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient."
326121|NCT01182493|O2|Outcome|Insulin Treatment With MDI|patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
326122|NCT01182493|O1|Outcome|Insulin Pump Treatment|"Patients will get an insulin pump~Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient."
326123|NCT01182493|E2|Reported Event|Insulin Treatment With MDI|patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
326124|NCT01182493|E1|Reported Event|Insulin Pump Treatment|"Patients will get an insulin pump~Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient."
326125|NCT01182480|B1|Baseline|Text Intervention|Group of study participants who received the text message intervention over a 3-month period.
326126|NCT01182480|P1|Participant Flow|Text Intervention|Group of study participants who received the text message intervention over a 3-month period. Participants received text messages 7, 2, and 1 day(s) prior to each of their scheduled appointments as recorded in the Denver Health scheduling system, and also received text messages prompts 3 times per week asking them to provide fasting blood sugar readings.
326127|NCT01182480|O1|Outcome|Text Intervention|Group of study participants who received the text message intervention over a 3-month period.
326128|NCT01182480|E1|Reported Event|Text Intervention|Group of study participants who received the text message intervention over a 3-month period.
326129|NCT01182428|B3|Baseline|Total|Total of all reporting groups
326130|NCT01182428|B2|Baseline|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326131|NCT01182428|B1|Baseline|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326132|NCT01182428|P2|Participant Flow|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326280|NCT01182194|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
326133|NCT01182428|P1|Participant Flow|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326134|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326135|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326136|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326137|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326138|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326139|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326140|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326141|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326142|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326143|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326144|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326145|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326146|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326147|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326148|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326149|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326150|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326151|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326152|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326153|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326154|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326155|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326156|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326157|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326158|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326159|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326160|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326161|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326162|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326163|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326164|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326165|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326166|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326167|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326168|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326169|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326170|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326171|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326172|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326173|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326174|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326175|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326176|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326177|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326178|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326179|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326180|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326181|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326182|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326183|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326184|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326185|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326186|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326187|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326188|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326189|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326190|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326191|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326192|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326193|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326194|NCT01182428|E2|Reported Event|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326195|NCT01182428|E1|Reported Event|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
326196|NCT01182415|B1|Baseline|High-dose Chemotherapy With Autologous Stem Cell Transplant|"Autologous stem cell transplant: Autologous stem cell transplant following high-dose chemotherapy~High-dose chemotherapy: High-dose chemotherapy with rituximab, thiotepa, busulfan, and cyclosphosphamide"
326197|NCT01182415|P1|Participant Flow|High-dose Chemotherapy With Autologous Stem Cell Transplant|"Autologous stem cell transplant: Autologous stem cell transplant following high-dose chemotherapy~High-dose chemotherapy: High-dose chemotherapy with rituximab, thiotepa, busulfan, and cyclosphosphamide"
326198|NCT01182415|O1|Outcome|High-dose Chemotherapy With Autologous Stem Cell Transplant|"Autologous stem cell transplant: Autologous stem cell transplant following high-dose chemotherapy~High-dose chemotherapy: High-dose chemotherapy with rituximab, thiotepa, busulfan, and cyclosphosphamide"
326281|NCT01182194|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
326199|NCT01182415|O1|Outcome|High-dose Chemotherapy With Autologous Stem Cell Transplant|"Autologous stem cell transplant: Autologous stem cell transplant following high-dose chemotherapy~High-dose chemotherapy: High-dose chemotherapy with rituximab, thiotepa, busulfan, and cyclosphosphamide"
326200|NCT01182415|O1|Outcome|High-dose Chemotherapy With Autologous Stem Cell Transplant|"Autologous stem cell transplant: Autologous stem cell transplant following high-dose chemotherapy~High-dose chemotherapy: High-dose chemotherapy with rituximab, thiotepa, busulfan, and cyclosphosphamide"
326201|NCT01182415|O1|Outcome|High-dose Chemotherapy With Autologous Stem Cell Transplant|"Autologous stem cell transplant: Autologous stem cell transplant following high-dose chemotherapy~High-dose chemotherapy: High-dose chemotherapy with rituximab, thiotepa, busulfan, and cyclosphosphamide"
326202|NCT01182415|E1|Reported Event|High-dose Chemotherapy With Autologous Stem Cell Transplant|"Autologous stem cell transplant: Autologous stem cell transplant following high-dose chemotherapy~High-dose chemotherapy: High-dose chemotherapy with rituximab, thiotepa, busulfan, and cyclosphosphamide"
326203|NCT01182376|B3|Baseline|Total|Total of all reporting groups
326204|NCT01182376|B2|Baseline|Multaq® (Dronedarone)|"Half of the patients will be prescribed dronedarone.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
326205|NCT01182376|B1|Baseline|Placebo|"Half of the patients will be assigned placebo.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
326206|NCT01182376|P2|Participant Flow|Multaq® (Dronedarone)|"Half of the patients will be prescribed dronedarone.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
326207|NCT01182376|P1|Participant Flow|Placebo|"Half of the patients will be assigned placebo.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
326208|NCT01182376|O2|Outcome|Multaq® (Dronedarone)|"Half of the patients will be prescribed dronedarone.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
326209|NCT01182376|O1|Outcome|Placebo|"Half of the patients will be assigned placebo.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
326210|NCT01182376|E2|Reported Event|Multaq® (Dronedarone)|"Half of the patients will be prescribed dronedarone.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
326211|NCT01182376|E1|Reported Event|Placebo|"Half of the patients will be assigned placebo.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
326212|NCT01182337|B3|Baseline|Total|Total of all reporting groups
326213|NCT01182337|B2|Baseline|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
326214|NCT01182337|B1|Baseline|Intradiscal rhGDF-5|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326215|NCT01182337|P2|Participant Flow|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
326216|NCT01182337|P1|Participant Flow|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326217|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
326218|NCT01182337|O1|Outcome|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326219|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
326220|NCT01182337|O1|Outcome|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326221|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
326222|NCT01182337|O1|Outcome|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326223|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
326224|NCT01182337|O1|Outcome|Intradiscal rhGDF-5|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326225|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
326484|NCT01181492|B2|Baseline|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
326226|NCT01182337|O1|Outcome|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326227|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
326228|NCT01182337|O1|Outcome|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326229|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
326230|NCT01182337|O1|Outcome|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326231|NCT01182337|E2|Reported Event|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
326232|NCT01182337|E1|Reported Event|Intradiscal rhGDF-5|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326233|NCT01182298|B1|Baseline|Standard|HCV INFECTED LATINO ARTICIPANTS
326234|NCT01182298|P1|Participant Flow|PegIFN and Ribavirin|"Latino Patients with hepatitis C receiving weekly pegIFN and ribavirin.~This is an observational study. The observed treatment is received and managed through their primary care."
326235|NCT01182298|O1|Outcome|Hepatitis C|latino participants with Hepatitis C
326236|NCT01182298|E1|Reported Event|Standard|Patients receiving weekly peg interferon and ribavirin for hCV treatment were studied This is an observational study. The observed treatment is received and managed through their primary care.
326237|NCT01182285|B1|Baseline|All Participants (Phase 1 and Phase 2 Schedule 2)|"A- Phase 1 Radioiodine-Resistant Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening~B2 - Phase 2 Schedule 2 Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks."
326238|NCT01182285|P3|Participant Flow|B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake)|Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
326239|NCT01182285|P2|Participant Flow|B1 - Phase 2 Schedule 1 (Increased Radioiodine Uptake)|Drug: Valproic Acid Week 11 - 17 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Drug: Cytomel (25 micrograms) Patients who exhibit an increased radioiodine uptake on Thyrogen scan post valproic acid therapy at week 10. Begin Liothyronine Sodium (Cytomel) for 4 weeks (25 micrograms twice a day)
326240|NCT01182285|P1|Participant Flow|A - Phase 1 Radioiodine Resistant Thyroid Cancer|Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening
326241|NCT01182285|O1|Outcome|A - Phase 1 Radioiodine Resistant Thyroid Cancer|Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening
326242|NCT01182285|O1|Outcome|B2 - Phase 2 Schedule 2 (No Increased Radiiodine Uptake)|Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
326243|NCT01182285|O1|Outcome|All Participants|A - Phase 1 Radioiodine Resistant Thyroid Cancer Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake) Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
326282|NCT01182194|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
326283|NCT01182194|E2|Reported Event|YAZ® (Reference) First|3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
326244|NCT01182285|O2|Outcome|B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake)|Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
326245|NCT01182285|O1|Outcome|A - Phase 1 Radioiodine Resistant Thyroid Cancer|Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening
326246|NCT01182285|E1|Reported Event|All Participants (Phase 1 and Phase 2 Schedule 2)|A - Phase 1 Radioiodine Resistant Thyroid Cancer Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake) Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
326247|NCT01182207|B3|Baseline|Total|Total of all reporting groups
326248|NCT01182207|B2|Baseline|YAZ® (Reference) First|3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
326249|NCT01182207|B1|Baseline|Drospirenone/Ethinyl Estradiol (Test) First|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
326250|NCT01182207|P2|Participant Flow|YAZ® (Reference) First|3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
326251|NCT01182207|P1|Participant Flow|Drospirenone/Ethinyl Estradiol (Test) First|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
326252|NCT01182207|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
326253|NCT01182207|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
326254|NCT01182207|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
326255|NCT01182207|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
326256|NCT01182207|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
326257|NCT01182207|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
326258|NCT01182207|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
326259|NCT01182207|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
326260|NCT01182207|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
326261|NCT01182207|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
326262|NCT01182207|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
326263|NCT01182207|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
326264|NCT01182207|E2|Reported Event|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
326265|NCT01182207|E1|Reported Event|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
326266|NCT01182194|B3|Baseline|Total|Total of all reporting groups
326267|NCT01182194|B2|Baseline|YAZ® (Reference) First|3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
326268|NCT01182194|B1|Baseline|Drospirenone/Ethinyl Estradiol (Test) First|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
326269|NCT01182194|P2|Participant Flow|YAZ® (Reference) First|3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
326270|NCT01182194|P1|Participant Flow|Drospirenone/Ethinyl Estradiol (Test) First|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
326271|NCT01182194|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
326272|NCT01182194|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
326273|NCT01182194|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
326274|NCT01182194|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
326275|NCT01182194|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
326276|NCT01182194|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
326277|NCT01182194|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
326278|NCT01182194|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
326279|NCT01182194|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
326284|NCT01182194|E1|Reported Event|Drospirenone/Ethinyl Estradiol (Test) First|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
326285|NCT01182181|B3|Baseline|Total|Total of all reporting groups
326286|NCT01182181|B2|Baseline|Arimidex® (Reference) First|1 mg Arimidex® Tablets reference product dosed in first period followed by 1 mg Anastrazole Tablets test product dosed in the second period.
326287|NCT01182181|B1|Baseline|Anastrazole (Test) First|1 mg Anastrozole Tablets test product dosed in first period followed by 1 mg Arimidex® Tablets reference product dosed in the second period.
326288|NCT01182181|P2|Participant Flow|Arimidex® (Reference) First|1 mg Arimidex® Tablets reference product dosed in first period followed by 1 mg Anastrazole Tablets test product dosed in the second period.
326289|NCT01182181|P1|Participant Flow|Anastrazole (Test) First|1 mg Anastrozole Tablets test product dosed in first period followed by 1 mg Arimidex® Tablets reference product dosed in the second period.
326290|NCT01182181|O2|Outcome|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
326291|NCT01182181|O1|Outcome|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period.
326292|NCT01182181|O2|Outcome|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
326293|NCT01182181|O1|Outcome|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period.
326294|NCT01182181|E2|Reported Event|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
326295|NCT01182181|E1|Reported Event|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period.
326296|NCT01182103|B3|Baseline|Total|Total of all reporting groups
326297|NCT01182103|B2|Baseline|Healthy Subjects|
326298|NCT01182103|B1|Baseline|Major Depressive Patients|
326299|NCT01182103|P2|Participant Flow|Healthy Subjects|
326300|NCT01182103|P1|Participant Flow|Major Depressive Patients|
326301|NCT01182103|O3|Outcome|Major Depressive Patients After Treatment|
326302|NCT01182103|O2|Outcome|Major Depressive Patients Before Treatment|
326303|NCT01182103|O1|Outcome|Healthy Subjects|
326304|NCT01182103|O3|Outcome|Major Depressive Patients After Treatment|
326305|NCT01182103|O2|Outcome|Major Depressive Patients Before Treatment|
326306|NCT01182103|O1|Outcome|Healthy Subjects|
326307|NCT01182103|O2|Outcome|Healthy Subjects|
326308|NCT01182103|O1|Outcome|Major Depressive Patients|
326309|NCT01182103|E2|Reported Event|Healthy Subjects|
326310|NCT01182103|E1|Reported Event|Major Depressive Patients|
326311|NCT01181986|B3|Baseline|Total|Total of all reporting groups
326312|NCT01181986|B2|Baseline|Sub-study 2: Exenatide IV|Intravenous infusion of (1) Saline+Exenatide, (2) Saline+Placebo or (3) Exendin-9+Exenatide on 3 seperate days, crossover study
326313|NCT01181986|B1|Baseline|Sub-study 1: Exenatide SC|Exenatide 5-10 ug or placebo sc BID/10 days, day 11 AM dose and meal test - crossover study
326314|NCT01181986|P3|Participant Flow|Exenatide IV (Sub-study 2)|Patients received in random order on single day an intravenous infusion of (1) Saline+Exenatide, (2) Exendin-9+Exenatide or (3) Saline+Placebo
326315|NCT01181986|P2|Participant Flow|Placebo Then Exenatide (Sub-study 1)|Patients received placebo sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
326316|NCT01181986|P1|Participant Flow|Exenatide Then Placebo (Sub-study 1)|Patients received exenatide 5-10 ug sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
326317|NCT01181986|O2|Outcome|Placebo (Sub-study 1)|Patients received placebo sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
326318|NCT01181986|O1|Outcome|Exenatide (Sub-study 1)|Patients received exenatide 5-10 ug sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
326319|NCT01181986|O2|Outcome|Placebo (Sub-study 1)|Patients received placebo sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
326320|NCT01181986|O1|Outcome|Exenatide (Sub-study 1)|Patients received exenatide 5-10 ug sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
326321|NCT01181986|O5|Outcome|Exendin-9+Exenatide (Sub-study 2)|Infusion of exendin-9 (min 0-75), added exenatide infusion (min 30-75)
326322|NCT01181986|O4|Outcome|Saline+Placebo (Sub-study 2)|Infusion of saline (min 0-75), added placebo infusion (min 30-75)
326323|NCT01181986|O3|Outcome|Saline+Exenatide (Sub-study 2)|Infusion of saline (min 0-75), added exenatide infusion (min 30-75)
326324|NCT01181986|O2|Outcome|Placebo (Sub-study 1)|Placebo sc BID for 10 days
326325|NCT01181986|O1|Outcome|Exenatide (Subs-study 1)|Exenatide: Exenatide 5-10 ug sc BID/10 days
326326|NCT01181986|E5|Reported Event|Exendin-9+Exenatide IV (Sub-study 2)|Intravenous infusion of exendin-9 (min 0-75), added intravenous infusion of placebo (min30-75)
326327|NCT01181986|E4|Reported Event|Saline+Placebo (Sub-study 2)|Intravenous infusion of saline (min 0-75), added intravenous infusion of placebo (min30-75)
326328|NCT01181986|E3|Reported Event|Saline+Exenatide IV (Sub-study 2)|Intravenous infusion of saline (min 0-75), added intravenous infusion of exenatide (min30-75)
326329|NCT01181986|E2|Reported Event|Placebo SC (Sub-study 1)|Placebo sc BID/10days, AM dose and meal test on day 11
326330|NCT01181986|E1|Reported Event|Exenatide SC (Sub-study 1)|Exenatide 5-10 ug sc BID/10 days, AM dose and meal test on day 11
326331|NCT01181947|B1|Baseline|Patients Undergoing TEVAR|"Those with a thoracic aortic aneurysm/dissection >~> TEVAR: Thoracic endovascular aneurysm repair"
326332|NCT01181947|P1|Participant Flow|Patients Undergoing TEVAR|"Those with a thoracic aortic aneurysm/dissection >~> TEVAR: Thoracic endovascular aneurysm repair"
326333|NCT01181947|O1|Outcome|Patients Undergoing TEVAR|"Those with a thoracic aortic aneurysm/dissection >~> TEVAR: Thoracic endovascular aneurysm repair"
326334|NCT01181947|O1|Outcome|Patients Undergoing TEVAR|"Those with a thoracic aortic aneurysm/dissection~TEVAR: Thoracic endovascular aneurysm repair"
326335|NCT01181947|E1|Reported Event|1. VCOUS|Medtronic VCOUS
326336|NCT01181921|B1|Baseline|Galantamine|Galantamine (capsules/oral use). Starting dose: 8 mg/day for 4 weeks; initial maintenance dose: 16 mg/day for 4 weeks; then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.
326337|NCT01181921|P1|Participant Flow|Galantamine|Galantamine (capsules/oral use). Starting dose: 8 mg/day for 4 weeks; initial maintenance dose: 16 mg/day for 4 weeks; then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.
326338|NCT01181921|O1|Outcome|Galantamine|Galantamine (capsules/oral use). Starting dose: 8 mg/day for 4 weeks; initial maintenance dose: 16 mg/day for 4 weeks; then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.
326339|NCT01181921|E1|Reported Event|Galantamine|Galantamine (capsules/oral use). Starting dose: 8 mg/day for 4 weeks; initial maintenance dose: 16 mg/day for 4 weeks; then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.
326340|NCT01181895|B4|Baseline|Total|Total of all reporting groups
326341|NCT01181895|B3|Baseline|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
326342|NCT01181895|B2|Baseline|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
326343|NCT01181895|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
326344|NCT01181895|P3|Participant Flow|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
326345|NCT01181895|P2|Participant Flow|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
326346|NCT01181895|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
326347|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
326348|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
326349|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
326350|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
326351|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
326352|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
326353|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
326354|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
326355|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
326356|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
326357|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
326358|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
326359|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
326360|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
326361|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
326362|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
326363|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
326364|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
326365|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
326366|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
326367|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
326368|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
326369|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
326370|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
326371|NCT01181895|E3|Reported Event|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
326372|NCT01181895|E2|Reported Event|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
326373|NCT01181895|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
326374|NCT01181804|B5|Baseline|Total|Total of all reporting groups
326375|NCT01181804|B4|Baseline|Boceprevir Capsules Then Tablets (Fasted)|Participants will start therapy with a single dose of boceprevir capsules, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir tablets, orally, following and overnight fast.
326376|NCT01181804|B3|Baseline|Boceprevir Tablets Then Capsules (Fasted)|Participants will start therapy with a single dose of boceprevir tablets, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir capsules, orally, following and overnight fast.
326449|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
326377|NCT01181804|B2|Baseline|Boceprevir Capsules Then Tablets (Fed)|Participants will start therapy with a single dose of boceprevir capsules, orally, in fed condition, and then 4 days later will take a single dose of boceprevir tablets, orally, in fed condition.
326378|NCT01181804|B1|Baseline|Boceprevir Tablets Then Capsules (Fed)|Participants will start therapy with a single dose of boceprevir tablets, orally, in fed condition, and then 4 days later will take a single dose of boceprevir capsules, orally, in fed condition.
326379|NCT01181804|P4|Participant Flow|Boceprevir Capsules Then Tablets (Fasted)|Participants will start therapy with a single dose of boceprevir capsules, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir tablets, orally, following and overnight fast.
326380|NCT01181804|P3|Participant Flow|Boceprevir Tablets Then Capsules (Fasted)|Participants will start therapy with a single dose of boceprevir tablets, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir capsules, orally, following and overnight fast.
326381|NCT01181804|P2|Participant Flow|Boceprevir Capsules Then Tablets ( Fed)|Participants will start therapy with a single dose of boceprevir capsules, orally, in fed condition, and then 4 days later will take a single dose of boceprevir tablets, orally, in fed condition.
326382|NCT01181804|P1|Participant Flow|Boceprevir Tablets Then Capsules ( Fed)|Participants will start therapy with a single dose of boceprevir tablets, orally, in fed condition, and then 4 days later will take a single dose of boceprevir capsules, orally, in fed condition.
326383|NCT01181804|O2|Outcome|Boceprevir Capsules (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
326384|NCT01181804|O1|Outcome|Boceprevir Tablets (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
326385|NCT01181804|O2|Outcome|Boceprevir Capsules (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
326386|NCT01181804|O1|Outcome|Boceprevir Tablets (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
326387|NCT01181804|O2|Outcome|Boceprevir Capsules (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
326388|NCT01181804|O1|Outcome|Boceprevir Tablets (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
326389|NCT01181804|O2|Outcome|Boceprevir Capsules (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
326390|NCT01181804|O1|Outcome|Boceprevir Tablets (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
326391|NCT01181804|O2|Outcome|Boceprevir Capsules (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
326392|NCT01181804|O1|Outcome|Boceprevir Tablets (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
326393|NCT01181804|O2|Outcome|Boceprevir Capsules (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
326394|NCT01181804|O1|Outcome|Boceprevir Tablets (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
326395|NCT01181804|O2|Outcome|Boceprevir Capsules (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
326396|NCT01181804|O1|Outcome|Boceprevir Tablets (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
326397|NCT01181804|O2|Outcome|Boceprevir Capsules (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
326398|NCT01181804|O1|Outcome|Boceprevir Tablets (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
326399|NCT01181804|E4|Reported Event|Boceprevir Capsules (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
326400|NCT01181804|E3|Reported Event|Boceprevir Tablets (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
326401|NCT01181804|E2|Reported Event|Boceprevir Capsules (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
326402|NCT01181804|E1|Reported Event|Boceprevir Tablets (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
326403|NCT01181778|B1|Baseline|All Participants|All participants who were enrolled in the study
326404|NCT01181778|P1|Participant Flow|All Participants|All participants who were enrolled in the study
326405|NCT01181778|O1|Outcome|All Qualified Participants|All healthy women who consulted their physician for information on contraceptive choices and were eligible for primary and secondary outcome measure analysis, based on the physician's assessment
326450|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
326406|NCT01181778|O2|Outcome|All Qualified Participants After Counseling|After counseling: All healthy women who were eligible for primary and secondary outcome measure analysis, based on the physician's assessment
326407|NCT01181778|O1|Outcome|All Qualified Participants Before Counseling|Before counseling: All healthy women who were eligible for primary and secondary outcome measure analysis, based on the physician's assessment
326408|NCT01181778|E1|Reported Event|All Qualified Participants|All healthy women who consulted their physician for information on contraceptive choices and were eligible for primary and secondary outcome measure analysis and safety analysis, based on the physician's assessment
326409|NCT01181726|B3|Baseline|Total|Total of all reporting groups
326410|NCT01181726|B2|Baseline|Activella® (Reference) First|1 mg/0.5 mg Activella® Tablets reference product dosed in first period followed by 1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in the second period.
326411|NCT01181726|B1|Baseline|Estradiol/Norethindrone Acetate (Test) First|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in first period followed by 1 mg/0.5 mg Activella® Tablets reference product dosed in the second period.
326412|NCT01181726|P2|Participant Flow|Activella® (Reference) First|1 mg/0.5 mg Activella® Tablets reference product dosed in first period followed by 1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in the second period.
326413|NCT01181726|P1|Participant Flow|Estradiol/Norethindrone Acetate (Test) First|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in first period followed by 1 mg/0.5 mg Activella® Tablets reference product dosed in the second period.
326414|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
326415|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
326416|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
326417|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
326418|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
326419|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
326420|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
326421|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
326422|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
326423|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
326424|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
326425|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
326426|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
326427|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
326428|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
326429|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
326430|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
326431|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
326432|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
326433|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
326434|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
326435|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
326436|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
326437|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
326438|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
326439|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
326440|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
326441|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
326442|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
326443|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
326444|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
326445|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
326446|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
326447|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
326448|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
326482|NCT01181492|B4|Baseline|Total|Total of all reporting groups
326451|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
326452|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
326453|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
326454|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
326455|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
326456|NCT01181726|E2|Reported Event|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
326457|NCT01181726|E1|Reported Event|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
326458|NCT01181609|B1|Baseline|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
326459|NCT01181609|P1|Participant Flow|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 milligrams per kilogram (mg/kg) intravenously (IV) per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
326460|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
326461|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
326462|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
326463|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
326464|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
326465|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
326466|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
326467|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
326468|NCT01181609|E1|Reported Event|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
326469|NCT01181531|B3|Baseline|Total|Total of all reporting groups
326470|NCT01181531|B2|Baseline|Cinacalcet|Cinacalcet Hydrochloride (Sensipar)
326471|NCT01181531|B1|Baseline|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
326472|NCT01181531|P2|Participant Flow|Cinacalcet|Cinacalcet Hydrochloride (Sensipar)
326473|NCT01181531|P1|Participant Flow|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
326474|NCT01181531|O2|Outcome|Cinacalcet|Cinacalcet Hydrochloride
326475|NCT01181531|O1|Outcome|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
326476|NCT01181531|O2|Outcome|Cinacalcet|Cinacalcet Hydrochloride
326477|NCT01181531|O1|Outcome|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
326478|NCT01181531|O2|Outcome|Cinacalcet|Cinacalcet Hydrochloride
326479|NCT01181531|O1|Outcome|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
326480|NCT01181531|E2|Reported Event|Cinacalcet|Cinacalcet Hydrochloride (Sensipar)
326481|NCT01181531|E1|Reported Event|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
326485|NCT01181492|B1|Baseline|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
326486|NCT01181492|P3|Participant Flow|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
326487|NCT01181492|P2|Participant Flow|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
326488|NCT01181492|P1|Participant Flow|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
326489|NCT01181492|O3|Outcome|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
326490|NCT01181492|O2|Outcome|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
326491|NCT01181492|O1|Outcome|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
326492|NCT01181492|O3|Outcome|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
326493|NCT01181492|O2|Outcome|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
326494|NCT01181492|O1|Outcome|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
326495|NCT01181492|O3|Outcome|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
326496|NCT01181492|O2|Outcome|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
326497|NCT01181492|O1|Outcome|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
326498|NCT01181492|E3|Reported Event|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
326499|NCT01181492|E2|Reported Event|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
326500|NCT01181492|E1|Reported Event|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
326501|NCT01181349|B1|Baseline|All Participants|"Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia~with neuromuscular blocking agents"
326502|NCT01181349|P1|Participant Flow|All Participants|"Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia~with neuromuscular blocking agents"
326503|NCT01181349|O2|Outcome|P07535 Study Participants With a TOF Ratio ≥0.9|Participants with TOF ratio ≥0.9 upon arrival at PACU, defined as indicating absence of residual neuromuscular blockade
326504|NCT01181349|O1|Outcome|P07535 Study Participants With a TOF Ratio <0.9|Participants with TOF ratio <0.9 upon arrival at PACU, defined as indicating presence of residual neuromuscular blockade
326505|NCT01181349|O2|Outcome|P07535 Study Participants With a TOF Ratio ≥0.9|Participants with TOF ratio ≥0.9 upon arrival at PACU, defined as indicating absence of residual neuromuscular blockade
326506|NCT01181349|O1|Outcome|P07535 Study Participants With a TOF Ratio <0.9|Participants with TOF ratio <0.9 upon arrival at PACU, defined as indicating presence of residual neuromuscular blockade
326507|NCT01181349|O2|Outcome|P07535 Study Participants With a TOF Ratio ≥0.9|Participants with TOF ratio ≥0.9 upon arrival at PACU, defined as indicating absence of residual neuromuscular blockade
326508|NCT01181349|O1|Outcome|P07535 Study Participants With a TOF Ratio <0.9|Participants with TOF ratio <0.9 upon arrival at PACU, defined as indicating presence of residual neuromuscular blockade
326509|NCT01181349|O2|Outcome|P07535 Study Participants With a TOF Ratio ≥0.9|Participants with TOF ratio ≥0.9 upon arrival at PACU, defined as indicating absence of residual neuromuscular blockade
326510|NCT01181349|O1|Outcome|P07535 Study Participants With a TOF Ratio <0.9|Participants with TOF ratio <0.9 upon arrival at PACU, defined as indicating presence of residual neuromuscular blockade
326511|NCT01181349|O1|Outcome|All Participants|"Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia~with neuromuscular blocking agents"
326512|NCT01181349|E1|Reported Event|All Participants|"Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia~with neuromuscular blocking agents"
326513|NCT01181323|B5|Baseline|Total|Total of all reporting groups
326514|NCT01181323|B4|Baseline|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
326515|NCT01181323|B3|Baseline|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
326516|NCT01181323|B2|Baseline|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
326517|NCT01181323|B1|Baseline|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
326518|NCT01181323|P4|Participant Flow|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
326519|NCT01181323|P3|Participant Flow|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
326520|NCT01181323|P2|Participant Flow|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
326521|NCT01181323|P1|Participant Flow|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection
326522|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
326523|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
326524|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
326525|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
326526|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
326527|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
326528|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
326529|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
326530|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
326531|NCT01181323|O3|Outcome|Infant LAIV 2011-2012|Infants of women enrolled to receive LAIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
326532|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
326533|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
326534|NCT01181323|O1|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
326535|NCT01181323|O4|Outcome|Infant TIV 2012-2013|Infants of women enrolled to receive TIV in the 2012-2013 season were enrolled separately in the protocol to be followed for safety outcomes.
326536|NCT01181323|O3|Outcome|Infant TIV 2011-2012|Infants of women enrolled to receive TIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
326537|NCT01181323|O2|Outcome|Infant LAIV 2012-2013|Infants of women enrolled to receive LAIV in the 2012-2013 season were enrolled separately in the protocol to be followed for safety outcomes.
326538|NCT01181323|O1|Outcome|Infant LAIV 2011-2012|Infants of women enrolled to receive LAIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
326539|NCT01181323|O4|Outcome|Infant TIV 2012-2013|Infants of women enrolled to receive TIV in the 2012-2013 season were enrolled separately in the protocol to be followed for safety outcomes.
326540|NCT01181323|O3|Outcome|Infant TIV 2011-2012|Infants of women enrolled to receive TIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
326541|NCT01181323|O2|Outcome|Infant LAIV 2012-2013|Infants of women enrolled to receive LAIV in the 2012-2013 season were enrolled separately in the protocol to be followed for safety outcomes.
326542|NCT01181323|O1|Outcome|Infant LAIV 2011-2012|Infants of women enrolled to receive LAIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
326543|NCT01181323|O4|Outcome|Infant TIV 2012-2013|Infants of women enrolled to receive TIV in the 2012-2013 season were enrolled separately in the protocol to be followed for safety outcomes.
326544|NCT01181323|O3|Outcome|Infant TIV 2011-2012|Infants of women enrolled to receive TIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
326545|NCT01181323|O2|Outcome|Infant LAIV 2012-2013|Infants of women enrolled to receive LAIV in the 2012-2013 season were enrolled separately in the protocol to be followed for safety outcomes.
326546|NCT01181323|O1|Outcome|Infant LAIV 2011-2012|Infants of women enrolled to receive LAIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
326547|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
326548|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
326549|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
326550|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
326551|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
326552|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
326553|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
326554|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
326555|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
326556|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
326557|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
326558|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
326559|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
326560|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
326561|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
326562|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
326563|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
326564|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
326565|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
326566|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
326567|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
326568|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
326569|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
326570|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
326571|NCT01181323|O2|Outcome|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
326572|NCT01181323|O1|Outcome|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
326573|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
326574|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
326575|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
326576|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
326577|NCT01181323|O4|Outcome|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
326578|NCT01181323|O3|Outcome|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
326579|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
326580|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
326581|NCT01181323|O2|Outcome|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
326582|NCT01181323|O1|Outcome|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
326583|NCT01181323|O4|Outcome|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
326584|NCT01181323|O3|Outcome|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
326634|NCT01181141|O1|Outcome|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~DU-176b (edoxaban)"
326693|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
326585|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
326586|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
326587|NCT01181323|O4|Outcome|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
326588|NCT01181323|O3|Outcome|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
326589|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
326590|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
326591|NCT01181323|E4|Reported Event|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
326592|NCT01181323|E3|Reported Event|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
326593|NCT01181323|E2|Reported Event|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
326594|NCT01181323|E1|Reported Event|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
326595|NCT01181271|B1|Baseline|Autologous Then Allogeneic Transplant|Autologous then allogeneic stem cell transplantation
326596|NCT01181271|P1|Participant Flow|Autologous Then Allogeneic Transplant|Autologous, then Allogeneic Stem Cell Transplantation
326597|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
326598|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
326599|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
326600|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
326601|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
326602|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
326635|NCT01181141|E2|Reported Event|Enoxaparin Sodium|"Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~Enoxaparin sodium 20mg"
326636|NCT01181141|E1|Reported Event|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~DU-176b (edoxaban)"
326637|NCT01181128|B4|Baseline|Total|Total of all reporting groups
326603|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
326604|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
326605|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
326606|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
326607|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
326608|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
326609|NCT01181271|E1|Reported Event|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
326610|NCT01181258|B1|Baseline|Patients Receiving NK Cell Infusion|"Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL~Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)~Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.~Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)~Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine~Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion~Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through"
326611|NCT01181258|P1|Participant Flow|Patients Receiving NK Cell Infusion|"Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL~Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)~Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.~Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)~Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine~Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion~Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through"
326638|NCT01181128|B3|Baseline|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
326639|NCT01181128|B2|Baseline|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
326692|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
326760|NCT01181011|O2|Outcome|Amlodipine 5mg|
326612|NCT01181258|O1|Outcome|Patients Receiving NK Cell Infusion|"Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL~Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)~Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.~Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)~Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine~Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion~Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through"
326613|NCT01181258|O1|Outcome|Patients Receiving NK Cell Infusion|"Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL~Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)~Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.~Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)~Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine~Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion~Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through"
326614|NCT01181258|O1|Outcome|Patients Receiving NK Cell Infusion|"Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL~Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)~Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.~Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)~Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine~Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion~Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through"
326615|NCT01181258|O1|Outcome|Patients Receiving NK Cell Infusion|"Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL~Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)~Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.~Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)~Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine~Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion~Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through"
326616|NCT01181258|E1|Reported Event|Patients Receiving NK Cell Infusion|"Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL~Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)~Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.~Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)~Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine~Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion~Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through"
326617|NCT01181167|B3|Baseline|Total|Total of all reporting groups
326618|NCT01181167|B2|Baseline|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
326619|NCT01181167|B1|Baseline|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
326620|NCT01181167|P2|Participant Flow|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
326621|NCT01181167|P1|Participant Flow|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
326622|NCT01181167|O2|Outcome|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
326623|NCT01181167|O1|Outcome|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
326624|NCT01181167|O2|Outcome|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
326625|NCT01181167|O1|Outcome|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
326626|NCT01181167|E2|Reported Event|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
326627|NCT01181167|E1|Reported Event|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
326628|NCT01181141|B3|Baseline|Total|Total of all reporting groups
326629|NCT01181141|B2|Baseline|Enoxaparin Sodium|"Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~Enoxaparin sodium 20mg"
326630|NCT01181141|B1|Baseline|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~DU-176b (edoxaban)"
326631|NCT01181141|P2|Participant Flow|Enoxaparin Sodium|"Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~Enoxaparin sodium 20mg"
326632|NCT01181141|P1|Participant Flow|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~DU-176b (edoxaban)"
326633|NCT01181141|O2|Outcome|Enoxaparin Sodium|"Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~Enoxaparin sodium 20mg"
326761|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
326640|NCT01181128|B1|Baseline|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326641|NCT01181128|P3|Participant Flow|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
326642|NCT01181128|P2|Participant Flow|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
326643|NCT01181128|P1|Participant Flow|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326644|NCT01181128|O1|Outcome|Perioperative Management (Surgery) Subgroup|Participants from any arm who underwent major surgery. The surgical period and dosing were dependent on the type of surgery the participant underwent.
326645|NCT01181128|O1|Outcome|Perioperative Management (Surgery) Subgroup|Participants from any arm who underwent major surgery. The surgical period and dosing were dependent on the type of surgery the participant underwent.
326646|NCT01181128|O1|Outcome|Perioperative Management (Surgery) Subgroup|Participants from any arm who underwent major surgery. The surgical period and dosing were dependent on the type of surgery the participant underwent.
326647|NCT01181128|O1|Outcome|Perioperative Management (Surgery) Subgroup|Participants from any arm who underwent major surgery. The surgical period and dosing were dependent on the type of surgery the participant underwent.
326648|NCT01181128|O1|Outcome|Perioperative Management (Surgery) Subgroup|Participants from any arm who underwent major surgery. The surgical period and dosing were dependent on the type of surgery the participant underwent.
326649|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
326650|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
326651|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326652|NCT01181128|O4|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
326653|NCT01181128|O3|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
326654|NCT01181128|O2|Outcome|Arm 1: Individualized Prophylaxis, Prestudy On-demand|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326655|NCT01181128|O1|Outcome|Arm 1: Individualized Prophylaxis, Prestudy Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326656|NCT01181128|O4|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
326657|NCT01181128|O3|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
326658|NCT01181128|O2|Outcome|Arm 1: Individualized Prophylaxis, Prestudy On-demand|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326659|NCT01181128|O1|Outcome|Arm 1: Individualized Prophylaxis, Prestudy Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326660|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326661|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326662|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326663|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326664|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326674|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
326675|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
326665|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326666|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326667|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326668|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326669|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326670|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326671|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
326672|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
326673|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326676|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326677|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
326678|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
326679|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326680|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
326681|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
326682|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326683|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
326684|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
326685|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326686|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
326687|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
326688|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326689|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
326690|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
326691|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326694|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326695|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
326696|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
326697|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326698|NCT01181128|O2|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
326699|NCT01181128|O1|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
326700|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326701|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326702|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326703|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326762|NCT01181011|O2|Outcome|Amlodipine 5mg|
326763|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
326764|NCT01181011|O2|Outcome|Amlodipine 5mg|
326765|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
326766|NCT01181011|O2|Outcome|Amlodipine 5mg|
326767|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
326768|NCT01181011|O2|Outcome|Amlodipine 5mg|
326769|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
326770|NCT01181011|O2|Outcome|Amlodipine 5mg|
326771|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
326704|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326705|NCT01181128|O2|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
326706|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326707|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
326708|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
326709|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326710|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
326711|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
326712|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326713|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
326714|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
326715|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326716|NCT01181128|O5|Outcome|Any Arm: Perioperative Management (Surgery) Subgroup|Participants from any arm who underwent major surgery. The surgical period and dosing were dependent on the type of surgery the participant underwent.
326717|NCT01181128|O4|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
326718|NCT01181128|O3|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
326719|NCT01181128|O2|Outcome|Arm 1: Individualized (Tailored) Prophylaxis, rFVIIIFc Only|"On rFVIIIFc Day 0, participants underwent pharmacokinetic (PK) analysis with a single dose of 50 IU/kg rFVIIIFc in order to estimate their PK parameters and guide the appropriate dose or interval of dosing.~After the PK assessment, participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by PK analyses, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326772|NCT01181011|O2|Outcome|Telmisartan 80mg|
326773|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
326774|NCT01181011|O2|Outcome|Telmisartan 80mg|
326720|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis, Advate|"Participants underwent pharmacokinetic (PK) analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) and then a single dose of 50 IU/kg rFVIIIFc (rFVIIIFc Day 0) within 8 weeks of the Advate dose. A >= 96 hour washout from Advate or any other FVIII product was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via IV injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326721|NCT01181128|O4|Outcome|All Arms: Total|All participants from the Individualized (Tailored) Prophylaxis, Weekly Prophylaxis, and Episodic (On-Demand) Dosing arms.
326722|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
326723|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
326724|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
326725|NCT01181128|E3|Reported Event|Episodic (On-Demand) Dosing|Initial single dose of 50 IU/kg of rFVIIIFc via IV injection followed by 10 to 50 IU/kg rFVIIIFc, as required to treat a bleeding episode
326726|NCT01181128|E2|Reported Event|Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
326727|NCT01181128|E1|Reported Event|Individualized (Tailored) Prophylaxis, rFVIIIFc|"Initial twice weekly dosing with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days to maintain a trough level of 1% to 3% (or higher, as clinically indicated) rFVIIIFc activity.~Prior to rFVIIIFc treatment, on rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with rFVIIIFc in order to estimate participant's PK parameters and guide the appropriate dose or interval of dosing. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~A subset of participants (Sequential PK Subgroup) also had PK profiling performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout from Advate or any other FVIII product was performed before the first PK dose of rFVIIIFc was administered."
326728|NCT01181102|B3|Baseline|Total|Total of all reporting groups
326729|NCT01181102|B2|Baseline|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
326730|NCT01181102|B1|Baseline|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
326731|NCT01181102|P2|Participant Flow|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
326732|NCT01181102|P1|Participant Flow|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
326733|NCT01181102|O2|Outcome|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
326734|NCT01181102|O1|Outcome|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
326735|NCT01181102|O2|Outcome|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
326736|NCT01181102|O1|Outcome|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
326737|NCT01181102|E2|Reported Event|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
326738|NCT01181102|E1|Reported Event|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
326739|NCT01181050|B3|Baseline|Total|Total of all reporting groups
326740|NCT01181050|B2|Baseline|Placebo|Subjects received a single dose of placebo
326741|NCT01181050|B1|Baseline|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
326742|NCT01181050|P2|Participant Flow|Placebo|Subjects received a single dose of placebo
326743|NCT01181050|P1|Participant Flow|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
326744|NCT01181050|O2|Outcome|Placebo|Subjects received a single dose of placebo
326745|NCT01181050|O1|Outcome|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
326746|NCT01181050|O2|Outcome|Placebo|Subjects received a single dose of placebo
326747|NCT01181050|O1|Outcome|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
326748|NCT01181050|O2|Outcome|Placebo|Subjects received a single dose of placebo
326749|NCT01181050|O1|Outcome|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
326750|NCT01181050|E2|Reported Event|Placebo|Subjects received a single dose of placebo
326751|NCT01181050|E1|Reported Event|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
326752|NCT01181011|B1|Baseline|All Participants|all patients will be assigned to 6 treatment sequences. cross-over design was adopted to ensure each patient would take amlodipine/telmisartan/combination single dose in randomized order
326753|NCT01181011|P1|Participant Flow|All Participants|
326754|NCT01181011|O3|Outcome|Amlodipine 5mg|
326755|NCT01181011|O2|Outcome|Telmisartan 80mg|
326756|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
326757|NCT01181011|O3|Outcome|Amlodipine 5mg|
326758|NCT01181011|O2|Outcome|Telmisartan 80mg|
326759|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
326800|NCT01180998|B3|Baseline|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
326801|NCT01180998|B2|Baseline|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, and used one of two toric lenses in a daily wear modality.
326802|NCT01180998|B1|Baseline|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
326803|NCT01180998|P3|Participant Flow|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
326804|NCT01180998|P2|Participant Flow|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, used one of two toric lenses in a daily wear modality.
326805|NCT01180998|P1|Participant Flow|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
326806|NCT01180998|O3|Outcome|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
326807|NCT01180998|O2|Outcome|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, used one of two toric lenses in a daily wear modality.
326808|NCT01180998|O1|Outcome|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
326809|NCT01180998|O3|Outcome|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
326810|NCT01180998|O2|Outcome|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, and used one of two toric lenses in a daily wear modality.
326811|NCT01180998|O1|Outcome|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
326812|NCT01180998|O3|Outcome|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
326813|NCT01180998|O2|Outcome|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, and used one of two toric lenses in a daily wear modality.
326814|NCT01180998|O1|Outcome|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
326815|NCT01180998|E3|Reported Event|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses will use one of two toric lenses in a daily wear modality.
326816|NCT01180998|E2|Reported Event|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, will use one of two toric lenses in a daily wear modality.
326817|NCT01180998|E1|Reported Event|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users will use one of two toric lenses in a daily wear modality.
326818|NCT01180985|B1|Baseline|All Subjects|All enrolled subjects at baseline.
326819|NCT01180985|P2|Participant Flow|Comfilcon A (Control)/Galyfilcon A (Test)|Each subject wore the assigned lens type for 7 +/- 1 days, according to the randomization scheme.
326820|NCT01180985|P1|Participant Flow|Galyfilcon A (Test)/Comfilcon A (Control)|Each subject wore the assigned lens type for 7 +/- 1 days, according to the randomization scheme.
326821|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All subjects who wore galyfilcon A lenses
326822|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All subjects who wore comfilcon A lenses
326823|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
326824|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation
326825|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
326826|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation
326827|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
326828|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation
326829|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
326830|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation
326831|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
326832|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation
326833|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
326834|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation
326835|NCT01180985|E1|Reported Event|Galyfilcon A Prototype/Comfilcon A|All enrolled subjects were to wear both lenses through the course of the study.
326836|NCT01180894|B3|Baseline|Total|Total of all reporting groups
326837|NCT01180894|B2|Baseline|Placebo|"Placebo~100 mg Normal saline"
326838|NCT01180894|B1|Baseline|Iron Sucrose|"100 mg IV TIW~Iron sucrose: 100 mg IV TIW"
326839|NCT01180894|P2|Participant Flow|Placebo|Placebo (100 mg normal saline)
326840|NCT01180894|P1|Participant Flow|Iron Sucrose|"100 mg IV TIW~Iron sucrose: 100 mg IV TIW"
326841|NCT01180894|O2|Outcome|Placebo|Placebo (100 mg normal saline)
326842|NCT01180894|O1|Outcome|Iron Sucrose|"100 mg IV TIW~Iron sucrose: 100 mg IV TIW"
326843|NCT01180894|O2|Outcome|Placebo|Placebo (100 mg normal saline)
326844|NCT01180894|O1|Outcome|Iron Sucrose|"100 mg IV TIW~Iron sucrose: 100 mg IV TIW"
326845|NCT01180894|O2|Outcome|Placebo|"Placebo~100 mg Normal saline"
326846|NCT01180894|O1|Outcome|Iron Sucrose|"100 mg IV TIW~Iron sucrose: 100 mg IV TIW"
326847|NCT01180894|O2|Outcome|Placebo|"Pacebo - Normal Saline~Placebo"
326848|NCT01180894|O1|Outcome|Iron Sucrose|"100 mg IV TIW~Iron sucrose: 100 mg IV TIW"
326849|NCT01180894|E2|Reported Event|Placebo|"Placebo~100 mg Normal saline"
326850|NCT01180894|E1|Reported Event|Iron Sucrose|"100 mg IV TIW~Iron sucrose: 100 mg IV TIW"
326851|NCT01180790|B8|Baseline|Total|Total of all reporting groups
326852|NCT01180790|B7|Baseline|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326853|NCT01180790|B6|Baseline|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326854|NCT01180790|B5|Baseline|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326855|NCT01180790|B4|Baseline|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily for 28 days~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326856|NCT01180790|B3|Baseline|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326857|NCT01180790|B2|Baseline|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326858|NCT01180790|B1|Baseline|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326859|NCT01180790|P7|Participant Flow|Segment 2 - 800 mg ACH-0141625 for 12 Weeks|"ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for up to 24 or 48 weeks"
326860|NCT01180790|P6|Participant Flow|Segment 2 - 400 mg ACH-0141625 for 12 Weeks|"ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for up to 24 or 48 weeks"
326861|NCT01180790|P5|Participant Flow|Segment 2: 200 mg ACH-0141625 for 12 Weeks|"ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for up to 24 or 48 weeks"
326862|NCT01180790|P4|Participant Flow|Segment 1: Placebo for 28 Days|"Placebo: Powder in capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326863|NCT01180790|P3|Participant Flow|Segment 1: 800 mg ACH-0141625 for 28 Days|"ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326864|NCT01180790|P2|Participant Flow|Segment 1: 400 mg ACH-0141625 for 28 Days|"ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326865|NCT01180790|P1|Participant Flow|Segment 1: 200 mg ACH-0141625 for 28 Days|"ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326866|NCT01180790|O7|Outcome|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326867|NCT01180790|O6|Outcome|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326868|NCT01180790|O5|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326940|NCT01180777|E1|Reported Event|All Subjects|Subjects were to wear all three lenses over the course of the study. Due to the non-ocular related AE, all subjects are summarized to report the occurrence of event.
326869|NCT01180790|O4|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily for 28 days~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326870|NCT01180790|O3|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326871|NCT01180790|O2|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326872|NCT01180790|O1|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326873|NCT01180790|O7|Outcome|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326874|NCT01180790|O6|Outcome|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326875|NCT01180790|O5|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326876|NCT01180790|O4|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily for 28 days~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326877|NCT01180790|O3|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326878|NCT01180790|O2|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326879|NCT01180790|O1|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326880|NCT01180790|O7|Outcome|Segment 2 : 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326881|NCT01180790|O6|Outcome|Segment 2: 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326882|NCT01180790|O5|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326883|NCT01180790|O4|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily for 28 days~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326884|NCT01180790|O3|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326885|NCT01180790|O2|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326886|NCT01180790|O1|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326887|NCT01180790|O7|Outcome|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326888|NCT01180790|O6|Outcome|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326889|NCT01180790|O5|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 200 mg oral capsule once daily for~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326890|NCT01180790|O4|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326891|NCT01180790|O3|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326892|NCT01180790|O2|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326893|NCT01180790|O1|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326894|NCT01180790|O7|Outcome|Segment 2: 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326895|NCT01180790|O6|Outcome|Segment 2: 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326896|NCT01180790|O5|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326897|NCT01180790|O4|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326898|NCT01180790|O3|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326899|NCT01180790|O2|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326900|NCT01180790|O1|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326901|NCT01180790|O3|Outcome|Segment 2: 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326902|NCT01180790|O2|Outcome|Segment 2: 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326903|NCT01180790|O1|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326904|NCT01180790|O4|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: powder in capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326905|NCT01180790|O3|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326906|NCT01180790|O2|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326907|NCT01180790|O1|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326908|NCT01180790|O3|Outcome|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~Ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326909|NCT01180790|O2|Outcome|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~Ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326910|NCT01180790|O1|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326911|NCT01180790|O3|Outcome|Segment 2: 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a plus ribavirin for up to 24 or 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326912|NCT01180790|O2|Outcome|Segment 2: 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a plus ribavirin for up to 24 or 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326913|NCT01180790|O1|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326914|NCT01180790|O4|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326915|NCT01180790|O3|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326916|NCT01180790|O2|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326917|NCT01180790|O1|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326918|NCT01180790|O4|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326919|NCT01180790|O3|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326920|NCT01180790|O2|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326921|NCT01180790|O1|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326922|NCT01180790|E7|Reported Event|Segment 1 - Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326923|NCT01180790|E6|Reported Event|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326924|NCT01180790|E5|Reported Event|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326925|NCT01180790|E4|Reported Event|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326926|NCT01180790|E3|Reported Event|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326927|NCT01180790|E2|Reported Event|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
326928|NCT01180790|E1|Reported Event|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
326929|NCT01180777|B1|Baseline|All Subjects|Subjects were to wear all three lenses over the course of the study.
326930|NCT01180777|P1|Participant Flow|All Subjects|All subjects who enrolled, randomized, and exposed to the study lenses. Subjects where randomized to a study arm and wore all three of the study lenses by study completion. Randomization was to the arms as outlined in the 'arms' section of the protocol.
326942|NCT01180660|B2|Baseline|Placebo|"Placebo Normal Saline Infusion~Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period"
326943|NCT01180660|B1|Baseline|Lidocaine|"Lidocaine infusion~Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period"
326944|NCT01180660|P2|Participant Flow|Placebo|"Placebo Normal Saline Infusion~Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period"
326945|NCT01180660|P1|Participant Flow|Lidocaine|"Lidocaine infusion~Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period"
326946|NCT01180660|O2|Outcome|Placebo|"Placebo Normal Saline Infusion~Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period"
326947|NCT01180660|O1|Outcome|Lidocaine|"Lidocaine infusion~Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period"
326948|NCT01180660|O2|Outcome|Placebo|"Placebo Normal Saline Infusion~Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period"
326949|NCT01180660|O1|Outcome|Lidocaine|"Lidocaine infusion~Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period"
326950|NCT01180660|E2|Reported Event|Placebo|"Placebo Normal Saline Infusion~Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period"
326951|NCT01180660|E1|Reported Event|Lidocaine|"Lidocaine infusion~Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period"
326952|NCT01180647|B3|Baseline|Total|Total of all reporting groups
326953|NCT01180647|B2|Baseline|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
326954|NCT01180647|B1|Baseline|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
326955|NCT01180647|P2|Participant Flow|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
326956|NCT01180647|P1|Participant Flow|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
326957|NCT01180647|O2|Outcome|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
326958|NCT01180647|O1|Outcome|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
326959|NCT01180647|O2|Outcome|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
326960|NCT01180647|O1|Outcome|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
326961|NCT01180647|O2|Outcome|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
326962|NCT01180647|O1|Outcome|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
326963|NCT01180647|O2|Outcome|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
326964|NCT01180647|O1|Outcome|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
327004|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
326965|NCT01180647|O2|Outcome|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
326966|NCT01180647|O1|Outcome|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
326967|NCT01180647|O2|Outcome|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
326968|NCT01180647|O1|Outcome|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
326969|NCT01180647|E2|Reported Event|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
326970|NCT01180647|E1|Reported Event|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
326971|NCT01180478|B3|Baseline|Total|Total of all reporting groups
326972|NCT01180478|B2|Baseline|White Light Trans Urethral Resection|"White Light Trans Urethral Resection~White Light: White Light Cystoscopy"
326973|NCT01180478|B1|Baseline|Narrow Band Imaging|"Narrow Band Imaging (NBI)~Narrow Band Imaging: Narrow Band Imaging"
326974|NCT01180478|P2|Participant Flow|White Light Trans Urethral Resection|"White Light Trans Urethral Resection~White Light: White Light Cystoscopy"
326975|NCT01180478|P1|Participant Flow|Narrow Band Imaging|"Narrow Band Imaging (NBI)~Narrow Band Imaging: Narrow Band Imaging"
326976|NCT01180478|O2|Outcome|White Light Trans Urethral Resection|"White Light Trans Urethral Resection~White Light: White Light Cystoscopy"
326977|NCT01180478|O1|Outcome|Narrow Band Imaging|"Narrow Band Imaging (NBI)~Narrow Band Imaging: Narrow Band Imaging"
326978|NCT01180478|O2|Outcome|White Light Trans Urethral Resection|"White Light Trans Urethral Resection~White Light: White Light Cystoscopy"
326979|NCT01180478|O1|Outcome|Narrow Band Imaging|"Narrow Band Imaging (NBI)~Narrow Band Imaging: Narrow Band Imaging"
326980|NCT01180478|O2|Outcome|White Light Trans Urethral Resection|"White Light Trans Urethral Resection~White Light: White Light Cystoscopy"
326981|NCT01180478|O1|Outcome|Narrow Band Imaging|"Narrow Band Imaging (NBI)~Narrow Band Imaging: Narrow Band Imaging"
326982|NCT01180478|O2|Outcome|White Light Trans Urethral Resection|"White Light Trans Urethral Resection~White Light: White Light Cystoscopy"
326983|NCT01180478|O1|Outcome|Narrow Band Imaging|"Narrow Band Imaging (NBI)~Narrow Band Imaging: Narrow Band Imaging"
326984|NCT01180478|O2|Outcome|White Light|
326985|NCT01180478|O1|Outcome|Narrow Band Imaging|
326986|NCT01180478|E2|Reported Event|White Light Trans Urethral Resection|"White Light Trans Urethral Resection~White Light: White Light Cystoscopy"
326987|NCT01180478|E1|Reported Event|Narrow Band Imaging|"Narrow Band Imaging (NBI)~Narrow Band Imaging: Narrow Band Imaging"
326988|NCT01180400|B3|Baseline|Total|Total of all reporting groups
326989|NCT01180400|B2|Baseline|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
326990|NCT01180400|B1|Baseline|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
326991|NCT01180400|P2|Participant Flow|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
326992|NCT01180400|P1|Participant Flow|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
326993|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
326994|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
326995|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
326996|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
326997|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
326998|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
326999|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
327000|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
327001|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
327002|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
327003|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
327005|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
327006|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
327007|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
327008|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
327009|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
327010|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
327011|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
327012|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
327013|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
327014|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
327015|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
327016|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
327017|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
327018|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
327019|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
327020|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
327021|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
327022|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
327023|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
327024|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
327025|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
327026|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
327027|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
327028|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
327029|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
327030|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
327031|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
327032|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
327033|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
327034|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
327035|NCT01180400|E2|Reported Event|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
327036|NCT01180400|E1|Reported Event|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
327037|NCT01180296|B3|Baseline|Total|Total of all reporting groups
327038|NCT01180296|B2|Baseline|Placebo|Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
327039|NCT01180296|B1|Baseline|Progesterone Group|400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery
327040|NCT01180296|P2|Participant Flow|Placebo|Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
327041|NCT01180296|P1|Participant Flow|Progesterone Group|400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery
327042|NCT01180296|O2|Outcome|Placebo|Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
327043|NCT01180296|O1|Outcome|Progesterone Group|400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery
327044|NCT01180296|E2|Reported Event|Placebo|Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
327045|NCT01180296|E1|Reported Event|Progesterone Group|400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery
327046|NCT01180244|B3|Baseline|Total|Total of all reporting groups
327047|NCT01180244|B2|Baseline|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
327419|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
327048|NCT01180244|B1|Baseline|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
327049|NCT01180244|P2|Participant Flow|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
327050|NCT01180244|P1|Participant Flow|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
327051|NCT01180244|O2|Outcome|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
327052|NCT01180244|O1|Outcome|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
327053|NCT01180244|O2|Outcome|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
327054|NCT01180244|O1|Outcome|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
327055|NCT01180244|O2|Outcome|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
327056|NCT01180244|O1|Outcome|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
327057|NCT01180244|O2|Outcome|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
327058|NCT01180244|O1|Outcome|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
327059|NCT01180244|O2|Outcome|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
327060|NCT01180244|O1|Outcome|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
327061|NCT01180244|E2|Reported Event|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
327138|NCT01179737|E4|Reported Event|Cohort 2: Placebo|Participants were assigned to receive placebo to match 50mg and / or 150mg capsules during 168 days
327062|NCT01180244|E1|Reported Event|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
327063|NCT01180127|B5|Baseline|Total|Total of all reporting groups
327064|NCT01180127|B4|Baseline|Wait List Control Food Additive Without Flavonol|"12 weeks of wait list control status plus food additive without the flavanol containing food product~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
327065|NCT01180127|B3|Baseline|Exercise, Food Additive Lacking Flavonol|"aerobic training plus food additive without flavanol~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
327066|NCT01180127|B2|Baseline|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
327067|NCT01180127|B1|Baseline|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
327068|NCT01180127|P4|Participant Flow|Wait List Control Food Additive Without Flavanol|"12 weeks of wait list control status plus food additive without the flavanol containing food product~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
327069|NCT01180127|P3|Participant Flow|Exercise, Food Additive Lacking Flavanol|"aerobic training plus food additive without flavanol~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
327070|NCT01180127|P2|Participant Flow|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
327071|NCT01180127|P1|Participant Flow|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
327072|NCT01180127|O4|Outcome|Wait List Control Food Additive Without Flavanol|"12 weeks of wait list control status plus food additive without the flavanol containing food product~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
327073|NCT01180127|O3|Outcome|Exercise, Food Additive Lacking Flavanol|"aerobic training plus food additive without flavanol~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
327074|NCT01180127|O2|Outcome|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
327075|NCT01180127|O1|Outcome|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
327076|NCT01180127|O4|Outcome|Wait List Control Food Additive Without Flavanol|"12 weeks of wait list control status plus food additive without the flavanol containing food product~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
327077|NCT01180127|O3|Outcome|Exercise, Food Additive Lacking Flavanol|"aerobic training plus food additive without flavanol~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
327078|NCT01180127|O2|Outcome|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
327079|NCT01180127|O1|Outcome|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
327080|NCT01180127|O4|Outcome|Wait List Control Food Additive Without Flavonol|"12 weeks of wait list control status plus food additive without the flavonol containing food product~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavonol~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
327081|NCT01180127|O3|Outcome|Exercise, Food Additive Lacking Flavonol|"aerobic training plus food additive without flavonol~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavonol"
327082|NCT01180127|O2|Outcome|no Exercise, Dietary Intervention|"wait list control plus flavonol containing food product for 12 weeks~Flavonol containing food product: 12 weeks, 2X/day, 20g serving~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
327083|NCT01180127|O1|Outcome|Exercise, Dietary Intervention|"aerobic training and flavonol containing food product~Flavonol containing food product: 12 weeks, 2X/day, 20g serving~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
327084|NCT01180127|O4|Outcome|Wait List Control Food Additive Without Flavanol|"12 weeks of wait list control status plus food additive without the flavanol containing food product~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
327085|NCT01180127|O3|Outcome|Exercise, Food Additive Lacking Flavanol|"aerobic training plus food additive without flavanol~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
327171|NCT01179568|B5|Baseline|Total|Total of all reporting groups
327086|NCT01180127|O2|Outcome|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
327087|NCT01180127|O1|Outcome|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
327088|NCT01180127|E4|Reported Event|Wait List Control Food Additive Without Flavonol|"12 weeks of wait list control status plus food additive without the flavanol containing food product~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
327089|NCT01180127|E3|Reported Event|Exercise, Food Additive Lacking Flavonol|"aerobic training plus food additive without flavanol~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
327090|NCT01180127|E2|Reported Event|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
327091|NCT01180127|E1|Reported Event|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
327092|NCT01180049|B3|Baseline|Total|Total of all reporting groups
327093|NCT01180049|B2|Baseline|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
327094|NCT01180049|B1|Baseline|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
327095|NCT01180049|P2|Participant Flow|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
327096|NCT01180049|P1|Participant Flow|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
327097|NCT01180049|O2|Outcome|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
327098|NCT01180049|O1|Outcome|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
327099|NCT01180049|O2|Outcome|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
327100|NCT01180049|O1|Outcome|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
327101|NCT01180049|O2|Outcome|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
327102|NCT01180049|O1|Outcome|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
327103|NCT01180049|O2|Outcome|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
327104|NCT01180049|O1|Outcome|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
327105|NCT01180049|O2|Outcome|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
327106|NCT01180049|O1|Outcome|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
327107|NCT01180049|O2|Outcome|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
327137|NCT01179737|O1|Outcome|Change in Six-Minute Walk Distance (6MWD) From Baseline|During standardized walk course participants are connected to a portable pulse oximeter via a finger probe and instructed to walk at a comfortable speed for as far as they could manage in 6 minu
327108|NCT01180049|O1|Outcome|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
327109|NCT01180049|O2|Outcome|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
327110|NCT01180049|O1|Outcome|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
327111|NCT01180049|O2|Outcome|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
327112|NCT01180049|O1|Outcome|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
327113|NCT01180049|E2|Reported Event|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
327114|NCT01180049|E1|Reported Event|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
327115|NCT01179984|B1|Baseline|Single-Arm|The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
327116|NCT01179984|P1|Participant Flow|PTA and Study Stent|The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
327117|NCT01179984|O1|Outcome|PTA and Study Stent|The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
327118|NCT01179984|O1|Outcome|Single-Arm|The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
327119|NCT01179984|O1|Outcome|PTA and Study Stent|The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
327120|NCT01179984|E1|Reported Event|PTA and Study Stent|The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
327121|NCT01179919|B1|Baseline|Oseltamivir Dosed Group|"Oseltamivir 75 mg by mouth every 12 hours for 9 doses~Oseltamivir: Capsule, 75 mg by mouth for 9 doses"
327122|NCT01179919|P1|Participant Flow|Oseltamivir Dosed Group|"Oseltamivir 75 mg by mouth every 12 hours for 9 doses~Oseltamivir: Capsule, 75 mg by mouth for 9 doses"
327123|NCT01179919|O1|Outcome|Oseltamivir Dosed Group|"Oseltamivir 75 mg by mouth every 12 hours for 9 doses~Oseltamivir: Capsule, 75 mg by mouth for 9 doses"
327124|NCT01179919|O1|Outcome|Oseltamivir Dosed Group|"Oseltamivir 75 mg by mouth every 12 hours for 9 doses~Oseltamivir: Capsule, 75 mg by mouth for 9 doses"
327125|NCT01179919|E1|Reported Event|Oseltamivir Dosed Group|"Oseltamivir 75 mg by mouth every 12 hours for 9 doses~Oseltamivir: Capsule, 75 mg by mouth for 9 doses"
327126|NCT01179737|B5|Baseline|Total|Total of all reporting groups
327127|NCT01179737|B4|Baseline|Cohort 2: Placebo|Participants were assigned to receive placebo to match 50mg and / or 150mg capsules during 168 days
327128|NCT01179737|B3|Baseline|Cohort 2: Nilotinib|Participants were assigned to receive nilotinib 300 mg during 168 days
327129|NCT01179737|B2|Baseline|Cohort 1: Placebo|Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days.
327130|NCT01179737|B1|Baseline|Cohort 1: Nilotinib|Participants were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days.
327131|NCT01179737|P4|Participant Flow|Cohort 2: Placebo|Participants were assigned to receive placebo to match 50mg and / or 150mg capsules during 168 days
327132|NCT01179737|P3|Participant Flow|Cohort 2: Nilotinib|Participants were assigned to receive nilotinib 300 mg during 168 days
327133|NCT01179737|P2|Participant Flow|Cohort 1: Placebo|Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days.
327134|NCT01179737|P1|Participant Flow|Cohort 1: Nilotinib|Participants were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days.
327135|NCT01179737|O1|Outcome|Total Number of Adverse Events and Serious Adverse Events|Adverse events were summarized by the number of patients having any adverse event overall and presented in the safety section.
327136|NCT01179737|O1|Outcome|Change in Pulmonary Vascular Resistance (PVR)|"Change in pulmonary vascular resistance is measured via right heart catheter assessment according to local hospital procedures. It assesses several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Vascular Resistance (PVR).~Additional information about the outcome measure, if needed for clarification. Outcome Measures are: Specific key measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.~Examples:~Title: all cause mortality Time Frame: one year Safety Issue: No~Title: Evidence of clinically definite ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI Time Frame: within the first 30 days (plus or minus 3 days) after surgery Safety Issue: Yes"
327139|NCT01179737|E3|Reported Event|Cohort 2: Nilotinib|Participants were assigned to receive nilotinib 300 mg during 168 days
327140|NCT01179737|E2|Reported Event|Cohort 1: Placebo|Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days.
327141|NCT01179737|E1|Reported Event|Cohort 1: Nilotinib|Participants were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days.
327142|NCT01179672|B3|Baseline|Total|Total of all reporting groups
327143|NCT01179672|B2|Baseline|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
327144|NCT01179672|B1|Baseline|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1 then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
327145|NCT01179672|P2|Participant Flow|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
327146|NCT01179672|P1|Participant Flow|Duloxetine|30 milligrams (mg) duloxetine capsule administered orally, once daily (QD) during Week 1 then 60 mg duloxetine capsule orally, QD for the remaining 11 weeks of treatment. After a total 12 weeks of treatment or early discontinuation participants tapered off study drug (30 mg duloxetine capsule QD) for 1 week during taper.
327147|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
327148|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
327149|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
327150|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
327151|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
327152|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
327153|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
327154|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
327155|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
327156|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper
327157|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
327158|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
327159|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
327160|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
327161|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
327162|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
327163|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
327164|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
327165|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
327166|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
327167|NCT01179672|E4|Reported Event|Placebo Taper|After 12 weeks of treatment or early discontinuation, placebo administered orally, QD for 1 week during taper.
327168|NCT01179672|E3|Reported Event|Duloxetine Taper|After 12 weeks of treatment or early discontinuation, 30 mg duloxetine capsule administered orally, QD for 1 week during taper.
327169|NCT01179672|E2|Reported Event|Placebo Treatment|Placebo administered orally, QD for 12 weeks of the treatment.
327170|NCT01179672|E1|Reported Event|Duloxetine Treatment|30 mg duloxetine capsule administered orally, QD during Week 1 of the treatment; 60 mg capsule administered orally, QD for remaining 11 weeks of the treatment;
327172|NCT01179568|B4|Baseline|CGT With Placebo|"The targeted psychotherapy for complicated grief combined with inactive medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
327173|NCT01179568|B3|Baseline|CGT With Citalopram|"The targeted psychotherapy for complicated grief combined with SSRI medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
327174|NCT01179568|B2|Baseline|Placebo (Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.~Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
327175|NCT01179568|B1|Baseline|Citalopram|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
327176|NCT01179568|P4|Participant Flow|CGT With Placebo|"The targeted psychotherapy for complicated grief combined with inactive medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
327177|NCT01179568|P3|Participant Flow|CGT With Citalopram|"The targeted psychotherapy for complicated grief combined with SSRI medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
327178|NCT01179568|P2|Participant Flow|Placebo (Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.~Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
327179|NCT01179568|P1|Participant Flow|Citalopram|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
327180|NCT01179568|O3|Outcome|Complicated Grief Treatment With Placebo (CGT With PLA)|"The targeted psychotherapy for complicated grief combined with inactive medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
327181|NCT01179568|O2|Outcome|Complicated Grief Treatment With Citalopram (CGT With CIT)|"The targeted psychotherapy for complicated grief combined with SSRI medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
327182|NCT01179568|O1|Outcome|Citalopram (CIT)|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
327183|NCT01179568|O2|Outcome|Placebo (PLA; Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.~Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
327184|NCT01179568|O1|Outcome|Citalopram (CIT)|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
327185|NCT01179568|O3|Outcome|Complicated Grief Treatment With Placebo (CGT With PLA)|"The targeted psychotherapy for complicated grief combined with inactive medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
327186|NCT01179568|O2|Outcome|Complicated Grief Treatment With Citalopram (CGT With CIT)|"The targeted psychotherapy for complicated grief combined with SSRI medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
327187|NCT01179568|O1|Outcome|Citalopram (CIT)|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
327188|NCT01179568|O2|Outcome|Placebo (PLA; Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.~Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
327220|NCT01179516|O3|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
327189|NCT01179568|O1|Outcome|Citalopram (CIT)|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
327190|NCT01179568|O4|Outcome|Complicated Grief Treatment With Placebo (CGT With PLA)|"The targeted psychotherapy for complicated grief combined with inactive medication.~Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
327191|NCT01179568|O3|Outcome|Complicated Grief Treatment With Citalopram (CGT With CIT)|"The targeted psychotherapy for complicated grief combined with SSRI medication.~Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
327192|NCT01179568|O2|Outcome|Placebo (PLA; Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.~Placebo (PLA): 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
327193|NCT01179568|O1|Outcome|Citalopram (CIT)|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
327194|NCT01179568|E4|Reported Event|CGT With Placebo|"The targeted psychotherapy for complicated grief combined with inactive medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
327195|NCT01179568|E3|Reported Event|CGT With Citalopram|"The targeted psychotherapy for complicated grief combined with SSRI medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
327196|NCT01179568|E2|Reported Event|Placebo (Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.~Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
327197|NCT01179568|E1|Reported Event|Citalopram|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
327198|NCT01179516|B4|Baseline|Total|Total of all reporting groups
327199|NCT01179516|B3|Baseline|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
327200|NCT01179516|B2|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
327201|NCT01179516|B1|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
327202|NCT01179516|P3|Participant Flow|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
327203|NCT01179516|P2|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
327204|NCT01179516|P1|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
327205|NCT01179516|O3|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
327206|NCT01179516|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
327207|NCT01179516|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
327208|NCT01179516|O3|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
327209|NCT01179516|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
327210|NCT01179516|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
327211|NCT01179516|O3|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
327212|NCT01179516|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
327213|NCT01179516|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
327214|NCT01179516|O3|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
327215|NCT01179516|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
327216|NCT01179516|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
327217|NCT01179516|O3|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
327218|NCT01179516|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
327219|NCT01179516|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
327221|NCT01179516|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
327222|NCT01179516|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
327223|NCT01179516|E3|Reported Event|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
327224|NCT01179516|E2|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
327225|NCT01179516|E1|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
327226|NCT01179490|B1|Baseline|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
327227|NCT01179490|P1|Participant Flow|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
327228|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
327229|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
327230|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
327231|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
327232|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
327233|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
327234|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
327235|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
327236|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
327237|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
327262|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
327238|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
327239|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
327240|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
327241|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
327242|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
327243|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
327244|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
327245|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
327246|NCT01179490|E1|Reported Event|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
327247|NCT01179399|B1|Baseline|TAK-960|Given orally (PO) for 21 days of a 28-day treatment cycle.
327248|NCT01179399|P1|Participant Flow|TAK-960|Given orally (PO) for 21 days of a 28-day treatment cycle.
327249|NCT01179399|O1|Outcome|TAK-960|Given orally (PO) for 21 days of a 28-day treatment cycle.
327250|NCT01179399|E1|Reported Event|TAK-960|Given orally (PO) for 21 days of a 28-day treatment cycle.
327251|NCT01179347|B3|Baseline|Total|Total of all reporting groups
327252|NCT01179347|B2|Baseline|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
327253|NCT01179347|B1|Baseline|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
327254|NCT01179347|P2|Participant Flow|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
327255|NCT01179347|P1|Participant Flow|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
327256|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
327257|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
327258|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
327259|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
327260|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
327261|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
327420|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
327263|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
327264|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
327265|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
327266|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
327267|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
327268|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
327269|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
327270|NCT01179347|E4|Reported Event|Tio 5mcg Randomized Group Over the Study|
327271|NCT01179347|E3|Reported Event|Placebo Randomized Group Over the Open−Label Period|
327272|NCT01179347|E2|Reported Event|Tio 5mcg Randomized Group Over the Double−Blind Period|
327273|NCT01179347|E1|Reported Event|Placebo Randomized Group Over the Double−Blind Period|
327274|NCT01179334|B3|Baseline|Total|Total of all reporting groups
327275|NCT01179334|B2|Baseline|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327276|NCT01179334|B1|Baseline|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327277|NCT01179334|P2|Participant Flow|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327278|NCT01179334|P1|Participant Flow|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327279|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327280|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327281|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327282|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327283|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327284|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327285|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327286|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327287|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327288|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327289|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327290|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327291|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327355|NCT01179113|O1|Outcome|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
327421|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
327292|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327293|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327294|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327295|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327296|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327297|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327298|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327299|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327300|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327301|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327302|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327303|NCT01179334|E2|Reported Event|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327304|NCT01179334|E1|Reported Event|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
327305|NCT01179217|B3|Baseline|Total|Total of all reporting groups
327306|NCT01179217|B2|Baseline|Placebo|"Patients will be randomized to receive Placebo.~Placebo: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
327307|NCT01179217|B1|Baseline|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.~L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
327308|NCT01179217|P2|Participant Flow|Placebo|"Patients will be randomized to receive Placebo.~Placebo (100% maltodextrin): 0.3 g/kg of placebo will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
327309|NCT01179217|P1|Participant Flow|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.~L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
327356|NCT01179113|O2|Outcome|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
327357|NCT01179113|O1|Outcome|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
327310|NCT01179217|O2|Outcome|100% Maltodextrin|"Patients will be randomized to receive Placebo.~Placebo: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
327311|NCT01179217|O1|Outcome|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.~L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
327312|NCT01179217|O2|Outcome|100% Maltodextrin|"Patients will be randomized to receive Placebo.~Placebo: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
327313|NCT01179217|O1|Outcome|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.~L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
327314|NCT01179217|O2|Outcome|100% Maltodextrin|"Patients will be randomized to receive Placebo.~Placebo: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
327315|NCT01179217|O1|Outcome|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.~L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
327316|NCT01179217|O2|Outcome|100% Maltodextrin|"Patients will be randomized to receive Placebo.~Placebo: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
327317|NCT01179217|O1|Outcome|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.~L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
327318|NCT01179217|O2|Outcome|100% Maltodextrin|"Patients will be randomized to receive Placebo.~Placebo: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
327319|NCT01179217|O1|Outcome|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.~L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
327358|NCT01179113|O2|Outcome|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
327359|NCT01179113|O1|Outcome|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
327360|NCT01179113|E2|Reported Event|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
327320|NCT01179217|O2|Outcome|100% Maltodextrin|"Patients will be randomized to receive Placebo.~Placebo: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
327321|NCT01179217|O1|Outcome|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.~L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
327322|NCT01179217|O2|Outcome|Placebo|"Patients will be randomized to receive Placebo.~Placebo (100% maltodextrin): 0.3 g/kg of placebo will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
327323|NCT01179217|O1|Outcome|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.~L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
327324|NCT01179217|O2|Outcome|100% Maltodextrin|"Patients will be randomized to receive Placebo.~100% maltodextrin: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
327325|NCT01179217|O1|Outcome|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.~L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
327326|NCT01179217|O2|Outcome|100% Maltodextrin|"Patients will be randomized to receive Placebo.~100% maltodextrin: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
327327|NCT01179217|O1|Outcome|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.~L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
327328|NCT01179217|O2|Outcome|100% Maltodextrin|"Patients will be randomized to receive Placebo.~100% maltodextrin: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
327329|NCT01179217|O1|Outcome|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.~L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
327361|NCT01179113|E1|Reported Event|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
327362|NCT01179048|B3|Baseline|Total|Total of all reporting groups
327422|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
327423|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
327330|NCT01179217|E2|Reported Event|100% Maltodextrin|"Patients will be randomized to receive Placebo.~100% maltodextrin: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
327331|NCT01179217|E1|Reported Event|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.~L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
327332|NCT01179191|B1|Baseline|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
327333|NCT01179191|P1|Participant Flow|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
327334|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
327335|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
327336|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
327337|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
327338|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
327339|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
327340|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
327341|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
327342|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
327343|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
327344|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
327345|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
327346|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
327347|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
327348|NCT01179191|E1|Reported Event|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
327349|NCT01179113|B3|Baseline|Total|Total of all reporting groups
327350|NCT01179113|B2|Baseline|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
327351|NCT01179113|B1|Baseline|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
327352|NCT01179113|P2|Participant Flow|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
327353|NCT01179113|P1|Participant Flow|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
327354|NCT01179113|O2|Outcome|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
327363|NCT01179048|B2|Baseline|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
327364|NCT01179048|B1|Baseline|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
327365|NCT01179048|P2|Participant Flow|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
327366|NCT01179048|P1|Participant Flow|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
327367|NCT01179048|O2|Outcome|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
327368|NCT01179048|O1|Outcome|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
327369|NCT01179048|O2|Outcome|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
327370|NCT01179048|O1|Outcome|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
327371|NCT01179048|O2|Outcome|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
327372|NCT01179048|O1|Outcome|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
327373|NCT01179048|O2|Outcome|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
327374|NCT01179048|O1|Outcome|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
327375|NCT01179048|O2|Outcome|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
327376|NCT01179048|O1|Outcome|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
327377|NCT01179048|O2|Outcome|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
327378|NCT01179048|O1|Outcome|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
327418|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
327379|NCT01179048|E2|Reported Event|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
327380|NCT01179048|E1|Reported Event|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
327381|NCT01178944|B1|Baseline|Treatment (Pralatrexate, Oxaliplatin)|"Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.~Laboratory Biomarker Analysis: Correlative studies~Oxaliplatin: Given IV~Pralatrexate: Given IV"
327382|NCT01178944|P1|Participant Flow|Treatment (Pralatrexate, Oxaliplatin)|"Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.~Laboratory Biomarker Analysis: Correlative studies~Oxaliplatin: Given IV~Pralatrexate: Given IV"
327383|NCT01178944|O1|Outcome|Treatment (Pralatrexate, Oxaliplatin)|"Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.~Laboratory Biomarker Analysis: Correlative studies~Oxaliplatin: Given IV~Pralatrexate: Given IV"
327384|NCT01178944|O1|Outcome|Treatment (Pralatrexate, Oxaliplatin)|"Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.~Laboratory Biomarker Analysis: Correlative studies~Oxaliplatin: Given IV~Pralatrexate: Given IV"
327385|NCT01178944|O1|Outcome|Treatment (Pralatrexate, Oxaliplatin)|"Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.~Laboratory Biomarker Analysis: Correlative studies~Oxaliplatin: Given IV~Pralatrexate: Given IV"
327386|NCT01178944|O1|Outcome|Treatment (Pralatrexate, Oxaliplatin)|"Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.~Laboratory Biomarker Analysis: Correlative studies~Oxaliplatin: Given IV~Pralatrexate: Given IV"
327387|NCT01178944|O1|Outcome|Treatment (Pralatrexate, Oxaliplatin)|"Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.~Laboratory Biomarker Analysis: Correlative studies~Oxaliplatin: Given IV~Pralatrexate: Given IV"
327388|NCT01178944|O1|Outcome|Treatment (Pralatrexate, Oxaliplatin)|"Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.~Laboratory Biomarker Analysis: Correlative studies~Oxaliplatin: Given IV~Pralatrexate: Given IV"
327389|NCT01178944|E1|Reported Event|Treatment (Pralatrexate, Oxaliplatin)|"Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.~Laboratory Biomarker Analysis: Correlative studies~Oxaliplatin: Given IV~Pralatrexate: Given IV"
327390|NCT01178853|B3|Baseline|Total|Total of all reporting groups
327391|NCT01178853|B2|Baseline|Rosuvastatin/Pitavastatin|
327392|NCT01178853|B1|Baseline|Pitavastatin/Rosuvastatin|
327393|NCT01178853|P2|Participant Flow|Rosuvastatin/Pitavastatin|
327394|NCT01178853|P1|Participant Flow|Pitavastatin/Rosuvastatin|
327395|NCT01178853|O2|Outcome|Warfarin + Rosuvastatin|
327396|NCT01178853|O1|Outcome|Warfarin + Pitavastatin|
327397|NCT01178853|E2|Reported Event|Warfarin + Rosuvastatin|
327398|NCT01178853|E1|Reported Event|Warfarin + Pitavastatin|
327399|NCT01178827|B4|Baseline|Total|Total of all reporting groups
327400|NCT01178827|B3|Baseline|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
327401|NCT01178827|B2|Baseline|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
327402|NCT01178827|B1|Baseline|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
327403|NCT01178827|P3|Participant Flow|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
327404|NCT01178827|P2|Participant Flow|Oxybutynin IR|Oxybutynin IR (oxybutynin immediate release) 5 mg, three times daily for 2 days
327405|NCT01178827|P1|Participant Flow|Sanctura XR®|Sanctura XR® (trospium chloride), 60mg once daily for 10 days
327406|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
327407|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
327408|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
327409|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
327410|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
327411|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
327412|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
327413|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
327414|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
327415|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
327416|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
327417|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
327424|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
327425|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
327426|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
327427|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
327428|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
327429|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
327430|NCT01178827|E3|Reported Event|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
327431|NCT01178827|E2|Reported Event|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
327432|NCT01178827|E1|Reported Event|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
327433|NCT01178762|B1|Baseline|Azithromycin|DFA positive chlamydial conjunctivitis patients were orally administered azithromycin (400mg~1000mg, according to their age and body weight) once a week for consecutive two weeks, and the DFA tests were repeated 4 weeks after the treatment. If the DFA tests still showed positive results, an additional dose of azithromycin was orally administered, and another DFA test was performed again 4 weeks later. The augmented treatment with oral azithromycin (administration of one oral dose followed by DFA testing 4 weeks later) was continued until the DFA tests showed negative results.
327434|NCT01178762|P1|Participant Flow|Azithromycin|DFA positive chlamydial conjunctivitis patients were orally administered azithromycin (400mg~1000mg, according to their age and body weight) once a week for consecutive two weeks, and the DFA tests were repeated 4 weeks after the treatment. If the DFA tests still showed positive results, an additional dose of azithromycin was orally administered, and another DFA test was performed again 4 weeks later. The augmented treatment with oral azithromycin (administration of one oral dose followed by DFA testing 4 weeks later) was continued until the DFA tests showed negative results.
327435|NCT01178762|O1|Outcome|Azithromycin|DFA positive chlamydial conjunctivitis patients were orally administered azithromycin (400mg~1000mg, according to their age and body weight) once a week for consecutive two weeks, and the DFA tests were repeated 4 weeks after the treatment. If the DFA tests still showed positive results, an additional dose of azithromycin was orally administered, and another DFA test was performed again 4 weeks later. The augmented treatment with oral azithromycin (administration of one oral dose followed by DFA testing 4 weeks later) was continued until the DFA tests showed negative results.
327436|NCT01178762|E1|Reported Event|Azithromycin|DFA positive chlamydial conjunctivitis patients were orally administered azithromycin (400mg~1000mg, according to their age and body weight) once a week for consecutive two weeks, and the DFA tests were repeated 4 weeks after the treatment. If the DFA tests still showed positive results, an additional dose of azithromycin was orally administered, and another DFA test was performed again 4 weeks later. The augmented treatment with oral azithromycin (administration of one oral dose followed by DFA testing 4 weeks later) was continued until the DFA tests showed negative results.
327437|NCT01178671|B3|Baseline|Total|Total of all reporting groups
327438|NCT01178671|B2|Baseline|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
327439|NCT01178671|B1|Baseline|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
327440|NCT01178671|P2|Participant Flow|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
327441|NCT01178671|P1|Participant Flow|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
327442|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
327443|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
327444|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
327445|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
327446|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
327447|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
327448|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
327449|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
327450|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
327451|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
327452|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
327453|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
327454|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
327455|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
327456|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
327457|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
327458|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
327459|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
327460|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
327461|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
327462|NCT01178671|E2|Reported Event|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
327463|NCT01178671|E1|Reported Event|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
327464|NCT01178528|B4|Baseline|Total|Total of all reporting groups
327465|NCT01178528|B3|Baseline|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
327466|NCT01178528|B2|Baseline|Carvedilol|up to 25 mg b.i.d.
327467|NCT01178528|B1|Baseline|Ivabradine|up to 7.5 mg b.i.d.
327468|NCT01178528|P3|Participant Flow|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
327469|NCT01178528|P2|Participant Flow|Carvedilol|up to 25 mg b.i.d.
327470|NCT01178528|P1|Participant Flow|Ivabradine|up to 7.5 mg b.i.d.
327471|NCT01178528|O3|Outcome|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
327472|NCT01178528|O2|Outcome|Carvedilol|up to 25 mg b.i.d.
327473|NCT01178528|O1|Outcome|Ivabradine|up to 7.5 mg b.i.d.
327474|NCT01178528|O3|Outcome|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
327475|NCT01178528|O2|Outcome|Carvedilol|up to 25 mg b.i.d.
327476|NCT01178528|O1|Outcome|Ivabradine|7.5 mg b.i.d.
327477|NCT01178528|O3|Outcome|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
327478|NCT01178528|O2|Outcome|Carvedilol|up to 25 mg b.i.d.
327479|NCT01178528|O1|Outcome|Ivabradine|up to 7.5 mg b.i.d.
327480|NCT01178528|O3|Outcome|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
327481|NCT01178528|O2|Outcome|Carvedilol|up to 25 mg b.i.d.
327482|NCT01178528|O1|Outcome|Ivabradine|up to 7.5 mg b.i.d.
327483|NCT01178528|E3|Reported Event|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
327484|NCT01178528|E2|Reported Event|Carvedilol|up to 25 mg b.i.d.
327485|NCT01178528|E1|Reported Event|Ivabradine|up to 7.5 mg b.i.d.
327486|NCT01178385|B3|Baseline|Total|Total of all reporting groups
327487|NCT01178385|B2|Baseline|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
327488|NCT01178385|B1|Baseline|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
327489|NCT01178385|P2|Participant Flow|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
327606|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327490|NCT01178385|P1|Participant Flow|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
327491|NCT01178385|O2|Outcome|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
327492|NCT01178385|O1|Outcome|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
327493|NCT01178385|O2|Outcome|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
327494|NCT01178385|O1|Outcome|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
327495|NCT01178385|O2|Outcome|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
327496|NCT01178385|O1|Outcome|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
327497|NCT01178385|E2|Reported Event|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
327498|NCT01178385|E1|Reported Event|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
327499|NCT01178333|B4|Baseline|Total|Total of all reporting groups
327500|NCT01178333|B3|Baseline|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
327501|NCT01178333|B2|Baseline|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
327502|NCT01178333|B1|Baseline|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
327503|NCT01178333|P3|Participant Flow|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
327504|NCT01178333|P2|Participant Flow|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
327505|NCT01178333|P1|Participant Flow|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
327506|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
327507|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
327508|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
327509|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
327510|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
327511|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
327512|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
327513|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
327514|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
327515|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
327516|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
327517|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
327518|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
327519|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
327520|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
327521|NCT01178333|O2|Outcome|OD Result >= 1.0|Heparin-PF4 OD Test Results >= 1.0
327522|NCT01178333|O1|Outcome|OD Result < 1.0|Heparin-PF4 OD Test Results < 1.0
327523|NCT01178333|O2|Outcome|OD Result >= 1.0|Heparin-PF4 OD Test Results >= 1.0
327524|NCT01178333|O1|Outcome|OD Result < 1.0|Heparin-PF4 OD Test Results < 1.0
327525|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
327526|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
327527|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
327528|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
327529|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
327530|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
327531|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
327532|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
327533|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
327534|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
327535|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
327564|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
327536|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
327537|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
327538|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
327539|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
327540|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
327541|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
327542|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
327543|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
327544|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
327545|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
327546|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
327547|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
327548|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
327549|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
327550|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
327551|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
327552|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
327553|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
327554|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
327555|NCT01178333|E3|Reported Event|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
327556|NCT01178333|E2|Reported Event|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
327557|NCT01178333|E1|Reported Event|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
327558|NCT01178294|B1|Baseline|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
327559|NCT01178294|P1|Participant Flow|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
327560|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
327561|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
327562|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
327563|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
327565|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
327566|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
327567|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
327568|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
327569|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
327570|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
327571|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
327572|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
327573|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
327574|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
327575|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
327576|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
327577|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
327578|NCT01178294|E1|Reported Event|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
327579|NCT01178281|B3|Baseline|Total|Total of all reporting groups
327580|NCT01178281|B2|Baseline|Placebo (Oral Capsule)|Matching oral placebo Days 1 through Day 168
327581|NCT01178281|B1|Baseline|Pomalidomide 0.5 mg (Oral Capsule)|Pomalidomide 0.5 mg by mouth daily Days 1 through Day 168
327582|NCT01178281|P2|Participant Flow|Placebo (Oral Capsule)|One matching capsule by mouth daily Days 1 through Day 168
327583|NCT01178281|P1|Participant Flow|Pomalidomide 0.5 mg (Oral Capsule)|Pomalidomide 0.5 mg by mouth daily Days 1 through Day 168
327584|NCT01178281|O2|Outcome|Placebo (Oral Capsule)|One matching capsule by mouth daily Days 1 through Day 168
327585|NCT01178281|O1|Outcome|Pomalidomide 0.5mg (Oral Capsule)|Pomalidomide 0.5mg by mouth daily Days 1 through Day 168
327586|NCT01178281|E2|Reported Event|Placebo (Oral Capsule)|One matching capsule by mouth daily Days 1 through Day 168
327587|NCT01178281|E1|Reported Event|Pomalidomide 0.5mg (Oral Capsule)|Pomalidomide 0.5mg by mouth daily Days 1 through Day 168
327588|NCT01178268|B3|Baseline|Total|Total of all reporting groups
327589|NCT01178268|B2|Baseline|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327590|NCT01178268|B1|Baseline|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327591|NCT01178268|P2|Participant Flow|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327592|NCT01178268|P1|Participant Flow|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327593|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327594|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327595|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327596|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327597|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327598|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327599|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327600|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327601|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327602|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327603|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327604|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327605|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327607|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327608|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327609|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327610|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327611|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327612|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327613|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327614|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327615|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327616|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327617|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327618|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327619|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327620|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327621|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327622|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327623|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327624|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327625|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327626|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327627|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327628|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327629|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327630|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327631|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327632|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327633|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327634|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327635|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327636|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327637|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327638|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327639|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327640|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327641|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327642|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327643|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327644|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327645|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327646|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327647|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327648|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327649|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327650|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327651|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327652|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327653|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327654|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327655|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327656|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327657|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327658|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327659|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327660|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327661|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327662|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327663|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327664|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327665|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327666|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327667|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327668|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327669|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327670|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327671|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327672|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327673|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327674|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327675|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327676|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327677|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327678|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327679|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327680|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327681|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327682|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327683|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327684|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327685|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327686|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327687|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327688|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327689|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327690|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327691|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327692|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327693|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327694|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327695|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327696|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327697|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327698|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327699|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327700|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327701|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327702|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327703|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327704|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327705|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327706|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327707|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327708|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327709|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327710|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327711|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327712|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327713|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327714|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327715|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327716|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327717|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327718|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327719|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327720|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327721|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327722|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327723|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327724|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327725|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327726|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327727|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327728|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327729|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327730|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327731|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327732|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327733|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327734|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327735|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327736|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327737|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327738|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327739|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327740|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327741|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327742|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327743|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327744|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327745|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327746|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327747|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327748|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327749|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327750|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327751|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327752|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327753|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327754|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327755|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327756|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327757|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327758|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327759|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327760|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327761|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327762|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327763|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327764|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327765|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327766|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327767|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327768|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327769|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327770|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327771|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327772|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327773|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327774|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327775|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327776|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327777|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327778|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327779|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327780|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327781|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327782|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327783|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327784|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327785|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327786|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327787|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327788|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327789|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327790|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327791|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327792|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327793|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327794|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327795|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327796|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327797|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327798|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327799|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327800|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327801|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327802|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327803|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327804|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327805|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327806|NCT01178268|E2|Reported Event|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
327807|NCT01178268|E1|Reported Event|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
327808|NCT01178138|B1|Baseline|Prazosin Effects on Methamphetamine|"The order of placebo vs. active medication will be randomized.~oral placebo and methamphetamine 20mg po: Methamphetamine 20mg po will be given 30 minutes after oral placebo.~General Study Design. The Methamphetamine Tolerance regimen will always occur in the first study session. The medication regimen in sessions 2-6 will be randomized to one of the following five combinations of oral prazosin and iv methamphetamine.~Session 1 (Monday) Sessions 2 – 6 (Wed, Fri, Mon, Wed, Fri).~Oral placebo + methamphetamine (0, 15, 15 mg/70 kg)~Oral placebo + methamphetamine placebo (0, 0, 0 mg/70 kg)~Prazosin 1 mg po + methamphetamine placebo (0, 0, 0 mg/70 kg)~Prazosin 2 mg po + methamphetamine placebo (0, 0, 0 mg/70 kg)~Prazosin 1 mg po + methamphetamine (0, 15, 15 mg/70 kg)~Prazosin 2 mg po + methamphetamine (0, 15, 15 mg/70 kg)"
327809|NCT01178138|P1|Participant Flow|Prazosin Effects on Methamphetamine|"Double blind, placebo controlled study of the effect of prazosin on methamphetamine~The order of placebo vs. active medication will be randomized.~oral placebo and methamphetamine 20mg po: Methamphetamine 20mg po will be given 30 minutes after oral placebo.~General Study Design. The Methamphetamine Tolerance regimen will always occur in the first study session. The medication regimen in sessions 2-6 will be randomized to one of the following five combinations of oral prazosin and iv methamphetamine.~Session 1 (Monday) Sessions 2 - 6 (Wed, Fri, Mon, Wed, Fri).~Oral placebo + methamphetamine (0, 15, 15 mg/70 kg) Oral placebo + methamphetamine placebo (0, 0, 0 mg/70 kg) Prazosin 1 mg po + methamphetamine placebo (0, 0, 0 mg/70 kg) Prazosin 2 mg po + methamphetamine placebo (0, 0, 0 mg/70 kg) Prazosin 1 mg po + methamphetamine (0, 15, 15 mg/70 kg) Prazosin 2 mg po + methamphetamine (0, 15, 15 mg/70 kg)"
327810|NCT01178138|O6|Outcome|Prazosin Placebo and Methamphetamine 20 mg|
327811|NCT01178138|O5|Outcome|Prazosin 2 mg and Methamphetamine 20 mg|
327812|NCT01178138|O4|Outcome|Prazosin 1 mg and Methamphetamine 20 mg|
327813|NCT01178138|O3|Outcome|Prazosin 2 mg and Methamphetamine Placebo|
327814|NCT01178138|O2|Outcome|Prazosin 1 mg and Methamphetamine Placebo|
327815|NCT01178138|O1|Outcome|Prazosin Placebo and Methamphetamine Placebo|The order of placebo vs. active medication was be randomized to determine the how much, if any, prazosin changed the effects of methamphetamine. Visual analog scales were used to determine effects. Because only 1 subject completed the study, measures of dispersion were not reported.
327816|NCT01178138|O6|Outcome|Prazosin Placebo and Methamphetamine 20 mg|
327817|NCT01178138|O5|Outcome|Prazosin 2 mg and Methamphetamine 20 mg|
327818|NCT01178138|O4|Outcome|Prazosin 1 mg and Methamphetamine 20 mg|
327819|NCT01178138|O3|Outcome|Prazosin 2 mg and Methamphetamine Placebo|
327820|NCT01178138|O2|Outcome|Prazosin 1 mg and Methamphetamine Placebo|
327821|NCT01178138|O1|Outcome|Prazosin Placebo and Methamphetamine Placebo|The order of placebo vs. active medication was be randomized to determine the how much, if any, prazosin changed the effects of methamphetamine. Visual analog scales were used to determine effects. Because only 1 subject completed the study, measures of dispersion were not reported.
327822|NCT01178138|O6|Outcome|Prazosin Placebo and Methamphetamine 20 mg|
327823|NCT01178138|O5|Outcome|Prazosin 2 mg and Methamphetamine 20 mg|
327824|NCT01178138|O4|Outcome|Prazosin 1 mg and Methamphetamine 20 mg|
327825|NCT01178138|O3|Outcome|Prazosin 2 mg and Methamphetamine Placebo|
327826|NCT01178138|O2|Outcome|Prazosin 1 mg and Methamphetamine Placebo|
327827|NCT01178138|O1|Outcome|Prazosin Placebo and Methamphetamine Placebo|The order of placebo vs. active medication was be randomized to determine the how much, if any, prazosin changed the effects of methamphetamine. Visual analog scales were used to determine effects. Because only 1 subject completed the study, measures of dispersion were not reported.
327828|NCT01178138|E1|Reported Event|Prazosin Effects on Methamphetamine|Randomized placebo controlled trial of prazosin effects on methamphetamine
327829|NCT01178125|B1|Baseline|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
327830|NCT01178125|P1|Participant Flow|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
327831|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
327832|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
327833|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
327834|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
327835|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
327836|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
327837|NCT01178125|O3|Outcome|DR-102: Baseline Body Weight ≥90 kg|Subpopulation of total participants with a Baseline body weight ≥90 kg
327838|NCT01178125|O2|Outcome|DR-102: Baseline Body Weight <90 kg|Subpopulation of total participants with a Baseline body weight <90 kg
327839|NCT01178125|O1|Outcome|DR-102: Total|All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
327840|NCT01178125|O3|Outcome|DR-102: Baseline Body Weight ≥90 kg|Subpopulation of total participants with a Baseline body weight ≥90 kg
327841|NCT01178125|O2|Outcome|DR-102: Baseline Body Weight <90 kg|Subpopulation of total participants with a Baseline body weight <90 kg
327842|NCT01178125|O1|Outcome|DR-102: Total|All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
327843|NCT01178125|O3|Outcome|DR-102: Baseline Body Weight ≥90 kg|Subpopulation of total participants with a Baseline body weight ≥90 kg
327844|NCT01178125|O2|Outcome|DR-102: Baseline Body Weight <90 kg|Subpopulation of total participants with a Baseline body weight <90 kg
327845|NCT01178125|O1|Outcome|DR-102: Total|All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
327846|NCT01178125|O3|Outcome|DR-102: Baseline Body Weight ≥90 kg|Subpopulation of total participants with a Baseline body weight ≥90 kg
327847|NCT01178125|O2|Outcome|DR-102: Baseline Body Weight <90 kg|Subpopulation of total participants with a Baseline body weight <90 kg
327848|NCT01178125|O1|Outcome|DR-102: Total|All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
327849|NCT01178125|O2|Outcome|DR-102: Endpoint|at Week 51 of treatment with desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
327850|NCT01178125|O1|Outcome|DR-102: Baseline|prior to starting desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
327851|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
327852|NCT01178125|O3|Outcome|DR-102: Baseline Body Weight ≥90 kg|Subpopulation of total participants with a Baseline body weight ≥90 kg
327853|NCT01178125|O2|Outcome|DR-102: Baseline Body Weight <90 kg|Subpopulation of total participants with a Baseline body weight <90 kg
327854|NCT01178125|O1|Outcome|DR-102: Total|All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
327855|NCT01178125|E1|Reported Event|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
327856|NCT01178099|B5|Baseline|Total|Total of all reporting groups
327857|NCT01178099|B4|Baseline|Prasugrel 10 mg SD; 7.5 mg MD (Sickle Cell Disease)|Participants received a single 10-mg dose on Day 1 (SD), followed by 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
327858|NCT01178099|B3|Baseline|Prasugrel 10 mg SD; 5 mg MD (Sickle Cell Disease)|Participants received a single 10-mg dose on Day 1 (SD), followed by 5 mg/day (for participants<60 kilograms [kg]) for an additional 11 days (MD).
327859|NCT01178099|B2|Baseline|Prasugrel 10 mg SD; 7.5 mg MD (Healthy)|Participants received a single 10-mg dose on Day 1 (SD), followed by 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
327860|NCT01178099|B1|Baseline|Prasugrel 10 mg SD; 5 mg MD (Healthy)|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by 5 mg/day (for participants<60 kilograms [kg]) for an additional 11 days (multiple dose [MD]).
327861|NCT01178099|P2|Participant Flow|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
327862|NCT01178099|P1|Participant Flow|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
327863|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
327864|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
327865|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
327866|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
327867|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
327868|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
327997|NCT01177813|O2|Outcome|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
327869|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
327870|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
327871|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
327872|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
327873|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
327874|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
327875|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
327876|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
327877|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
327878|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
327879|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
327880|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
327881|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
327882|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
327883|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
327884|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
327885|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
327886|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
327887|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
327888|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
327889|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
327890|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
327891|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
327892|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
327893|NCT01178099|E6|Reported Event|All Prasugrel Sickle Cell Disease Participants|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
327894|NCT01178099|E5|Reported Event|Prasugrel 10/7.5 mg Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
327895|NCT01178099|E4|Reported Event|Prasugrel 10/5 mg Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by 5 mg/day (for participants<60 kg) for an additional 11 days (MD).
327896|NCT01178099|E3|Reported Event|All Prasugrel Healthy Participants|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
327897|NCT01178099|E2|Reported Event|Prasugrel 10/7.5 mg Healthy Participants|Participants received a single 10-mg dose on Day 1 (SD), followed by 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
327898|NCT01178099|E1|Reported Event|Prasugrel 10/5 mg Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by 5 mg/day (for participants<60 kilograms [kg]) for an additional 11 days (multiple dose [MD]).
327899|NCT01178073|B4|Baseline|Total|Total of all reporting groups
327900|NCT01178073|B3|Baseline|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
327901|NCT01178073|B2|Baseline|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
327902|NCT01178073|B1|Baseline|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
327903|NCT01178073|P3|Participant Flow|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
327904|NCT01178073|P2|Participant Flow|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
327905|NCT01178073|P1|Participant Flow|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
327906|NCT01178073|O4|Outcome|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
327907|NCT01178073|O3|Outcome|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
327908|NCT01178073|O2|Outcome|Monotherapy Pooled: Ambrisentan or Tadalafil|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks; or one tablet of 20 mg TAD and one tablet of TAD-matching placebo QD for the first 4 weeks. For participants on TAD, the dose of TAD was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and for participants on AMB, the dose of AMB may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
327909|NCT01178073|O1|Outcome|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
327910|NCT01178073|O4|Outcome|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
327911|NCT01178073|O3|Outcome|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
327912|NCT01178073|O2|Outcome|Monotherapy Pooled: Ambrisentan or Tadalafil|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks; or one tablet of 20 mg TAD and one tablet of TAD-matching placebo QD for the first 4 weeks. For participants on TAD, the dose of TAD was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and for participants on AMB, the dose of AMB may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
327993|NCT01177813|O1|Outcome|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
327913|NCT01178073|O1|Outcome|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
327914|NCT01178073|O4|Outcome|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
327915|NCT01178073|O3|Outcome|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
327916|NCT01178073|O2|Outcome|Monotherapy Pooled: Ambrisentan or Tadalafil|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks; or one tablet of 20 mg TAD and one tablet of TAD-matching placebo QD for the first 4 weeks. For participants on TAD, the dose of TAD was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and for participants on AMB, the dose of AMB may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
327917|NCT01178073|O1|Outcome|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
327918|NCT01178073|O4|Outcome|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
327919|NCT01178073|O3|Outcome|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
327920|NCT01178073|O2|Outcome|Monotherapy Pooled: Ambrisentan or Tadalafil|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks; or one tablet of 20 mg TAD and one tablet of TAD-matching placebo QD for the first 4 weeks. For participants on TAD, the dose of TAD was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and for participants on AMB, the dose of AMB may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
327921|NCT01178073|O1|Outcome|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
327922|NCT01178073|O4|Outcome|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
327923|NCT01178073|O3|Outcome|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
327924|NCT01178073|O2|Outcome|Monotherapy Pooled: Ambrisentan or Tadalafil|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks; or one tablet of 20 mg TAD and one tablet of TAD-matching placebo QD for the first 4 weeks. For participants on TAD, the dose of TAD was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and for participants on AMB, the dose of AMB may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
327925|NCT01178073|O1|Outcome|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
327926|NCT01178073|O4|Outcome|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
327994|NCT01177813|O5|Outcome|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
327995|NCT01177813|O4|Outcome|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
327927|NCT01178073|O3|Outcome|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
327928|NCT01178073|O2|Outcome|Monotherapy Pooled: Ambrisentan or Tadalafil|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks; or one tablet of 20 mg TAD and one tablet of TAD-matching placebo QD for the first 4 weeks. For participants on TAD, the dose of TAD was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and for participants on AMB, the dose of AMB may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
327929|NCT01178073|O1|Outcome|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
327930|NCT01178073|E3|Reported Event|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
327931|NCT01178073|E2|Reported Event|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
327932|NCT01178073|E1|Reported Event|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
327933|NCT01177969|B3|Baseline|Total|Total of all reporting groups
327934|NCT01177969|B2|Baseline|Wait-list|"A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.~Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'."
327935|NCT01177969|B1|Baseline|Cognitive-Behavioral Therapy|"The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.~Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques."
327936|NCT01177969|P2|Participant Flow|Wait-list|"A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.~Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'."
327937|NCT01177969|P1|Participant Flow|Cognitive-Behavioral Therapy|"The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.~Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques."
327938|NCT01177969|O2|Outcome|Wait-list|"A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.~Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'."
327939|NCT01177969|O1|Outcome|Cognitive-Behavioral Therapy|"The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.~Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques."
327940|NCT01177969|O2|Outcome|Wait-list|"A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.~Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'."
327941|NCT01177969|O1|Outcome|Cognitive-Behavioral Therapy|"The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.~Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques."
327942|NCT01177969|E2|Reported Event|Wait-list|"A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.~Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'."
327943|NCT01177969|E1|Reported Event|Cognitive-Behavioral Therapy|"The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.~Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques."
327944|NCT01177956|B1|Baseline|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
327945|NCT01177956|P1|Participant Flow|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
327946|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
327947|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
327948|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
327949|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
327950|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
327951|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
327952|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
327953|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
327954|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
328718|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
327955|NCT01177956|E2|Reported Event|Cetuximab + Cisplatin + 5-FU : Late Phase|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. Participants with end of treatment date after the last trial treatment date + 30 days or still on trial at the cut-off date.
327956|NCT01177956|E1|Reported Event|Cetuximab + Cisplatin + 5-FU : Treatment Emergent Phase|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. On or after the first dosing day of trial treatment and until 30 days after the last trial treatment administration.
327957|NCT01177943|B3|Baseline|Total|Total of all reporting groups
327958|NCT01177943|B2|Baseline|Atomoxetine Capsule Followed by Oral Solution|Participants received 2 capsules of atomoxetine (25 mg/capsule po), once. Participants received 50 mg of atomoxetine po, once (12.5 mL at 4 mg/mL).
327959|NCT01177943|B1|Baseline|Atomoxetine Oral Solution First, Then Capsule Formulation|Participants received 50 mg of atomoxetine orally (po), once (12.5 mL at 4 mg/mL). Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
327960|NCT01177943|P2|Participant Flow|Atomoxetine Capsule Formulation First, Then Oral Solution|Participants received 2 capsules of atomoxetine (25 mg/capsule po), once. Participants received 50 mg of atomoxetine po, once (12.5 mL at 4 mg/mL).
327961|NCT01177943|P1|Participant Flow|Atomoxetine Oral Solution First, Then Capsule Formulation|Participants received 50 milligrams (mg) of atomoxetine orally (po), once (12.5 milliliters [mL] at 4 mg/mL). Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
327962|NCT01177943|O2|Outcome|Atomoxetine Capsule Formulation|Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
327963|NCT01177943|O1|Outcome|Atomoxetine Oral Solution|Participants received 50 mg of atomoxetine orally (po), once (12.5 mL at 4 mg/mL).
327964|NCT01177943|O2|Outcome|Atomoxetine Capsule Formulation|Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
327965|NCT01177943|O1|Outcome|Atomoxetine Oral Solution|Participants received 50 mg of atomoxetine orally (po), once (12.5 mL at 4 mg/mL).
327966|NCT01177943|E2|Reported Event|Atomoxetine Capsule Formulation|Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
327967|NCT01177943|E1|Reported Event|Atomoxetine Oral Solution|Participants received 50 mg of atomoxetine orally (po), once (12.5 mL at 4 mg/mL).
327968|NCT01177813|B6|Baseline|Total|Total of all reporting groups
327969|NCT01177813|B5|Baseline|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
327970|NCT01177813|B4|Baseline|Sitagliptin 100|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
327971|NCT01177813|B3|Baseline|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
327972|NCT01177813|B2|Baseline|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
327973|NCT01177813|B1|Baseline|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
327974|NCT01177813|P5|Participant Flow|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label (OL) once daily in the morning.
327975|NCT01177813|P4|Participant Flow|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
327976|NCT01177813|P3|Participant Flow|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
327977|NCT01177813|P2|Participant Flow|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
327978|NCT01177813|P1|Participant Flow|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
327979|NCT01177813|O5|Outcome|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
327980|NCT01177813|O4|Outcome|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
327981|NCT01177813|O3|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
327982|NCT01177813|O2|Outcome|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
327983|NCT01177813|O1|Outcome|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
327984|NCT01177813|O5|Outcome|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
327985|NCT01177813|O4|Outcome|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
327986|NCT01177813|O3|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
327987|NCT01177813|O2|Outcome|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
327988|NCT01177813|O1|Outcome|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
327989|NCT01177813|O5|Outcome|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
327990|NCT01177813|O4|Outcome|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
327991|NCT01177813|O3|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
327992|NCT01177813|O2|Outcome|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
327996|NCT01177813|O3|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
327998|NCT01177813|O1|Outcome|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
327999|NCT01177813|E5|Reported Event|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label (OL) once daily in the morning.
328000|NCT01177813|E4|Reported Event|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
328001|NCT01177813|E3|Reported Event|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
328002|NCT01177813|E2|Reported Event|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
328003|NCT01177813|E1|Reported Event|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
328004|NCT01177800|B3|Baseline|Total|Total of all reporting groups
328005|NCT01177800|B2|Baseline|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
328006|NCT01177800|B1|Baseline|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
328007|NCT01177800|P2|Participant Flow|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
328008|NCT01177800|P1|Participant Flow|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
328009|NCT01177800|O2|Outcome|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
328010|NCT01177800|O1|Outcome|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
328011|NCT01177800|O2|Outcome|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
328012|NCT01177800|O1|Outcome|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
328013|NCT01177800|O2|Outcome|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
328014|NCT01177800|O1|Outcome|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
328015|NCT01177800|O2|Outcome|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
328016|NCT01177800|O1|Outcome|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
328017|NCT01177800|O2|Outcome|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
328018|NCT01177800|O1|Outcome|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
328019|NCT01177800|E2|Reported Event|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
328165|NCT01177228|E4|Reported Event|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
328020|NCT01177800|E1|Reported Event|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
328021|NCT01177735|B1|Baseline|Pomalidomide|Pomalidomide: Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.
328022|NCT01177735|P1|Participant Flow|Pomalidomide|Pomalidomide: Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.
328023|NCT01177735|O1|Outcome|Pomalidomide|Pomalidomide: Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.
328024|NCT01177735|E1|Reported Event|Pomalidomide|Pomalidomide: Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.
328025|NCT01177722|B5|Baseline|Total|Total of all reporting groups
328026|NCT01177722|B4|Baseline|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328027|NCT01177722|B3|Baseline|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328028|NCT01177722|B2|Baseline|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328029|NCT01177722|B1|Baseline|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328030|NCT01177722|P4|Participant Flow|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328031|NCT01177722|P3|Participant Flow|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328032|NCT01177722|P2|Participant Flow|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328033|NCT01177722|P1|Participant Flow|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328034|NCT01177722|O4|Outcome|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328035|NCT01177722|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328071|NCT01177553|B1|Baseline|Surgery Group|"Patients randomized to surgery will have hospital arrangements (laboratory tests and anesthesia assessment) finalized for a surgery the next day. Patients will sign the informed consent form.~Patients undergoing surgery will be admitted to Tampa General Hospital and will complete usual hospital admission procedures."
328719|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
328036|NCT01177722|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328037|NCT01177722|O1|Outcome|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328038|NCT01177722|O4|Outcome|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328039|NCT01177722|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328040|NCT01177722|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328041|NCT01177722|O1|Outcome|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328042|NCT01177722|O4|Outcome|Infanrix Hexa™|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328043|NCT01177722|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328044|NCT01177722|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328045|NCT01177722|O1|Outcome|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328046|NCT01177722|O4|Outcome|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328047|NCT01177722|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328048|NCT01177722|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328108|NCT01177384|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
328109|NCT01177293|B1|Baseline|Entire Study Population|Includes groups randomized to receive any treatment first (amlodipine capsule first and amlodipine ODT first).
328166|NCT01177228|E3|Reported Event|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
328049|NCT01177722|O1|Outcome|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328050|NCT01177722|O4|Outcome|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328051|NCT01177722|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328052|NCT01177722|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328053|NCT01177722|O1|Outcome|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328054|NCT01177722|E4|Reported Event|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328055|NCT01177722|E3|Reported Event|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328056|NCT01177722|E2|Reported Event|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328057|NCT01177722|E1|Reported Event|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
328058|NCT01177709|B1|Baseline|Metformin|Metformin: metformin 500- 2500 mg/day.
328059|NCT01177709|P1|Participant Flow|Metformin|Metformin: metformin 500- 2500 mg/day.
328060|NCT01177709|O1|Outcome|Metformin|Metformin: metformin 500- 2500 mg/day.
328061|NCT01177709|O1|Outcome|Metformin|Metformin: metformin 500- 2500 mg/day.
328062|NCT01177709|O1|Outcome|Metformin|Metformin: metformin 500- 2500 mg/day.
328063|NCT01177709|E1|Reported Event|Metformin|Metformin: metformin 500- 2500 mg/day.
328064|NCT01177670|B1|Baseline|Enrolled|All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
328065|NCT01177670|P1|Participant Flow|Enrolled|All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
328066|NCT01177670|O1|Outcome|Enrolled|All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
328067|NCT01177670|O1|Outcome|Enrolled|All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
328068|NCT01177670|E1|Reported Event|Enrolled|All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
328069|NCT01177553|B3|Baseline|Total|Total of all reporting groups
328070|NCT01177553|B2|Baseline|Expectant Management Group|Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient’s perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy.
328164|NCT01177228|O1|Outcome|Placebo|Vedolizumab-matching placebo, intravenous (IV), one 30-minute infusion on Days 1, 15, 29 and 85.
328072|NCT01177553|P2|Participant Flow|Expectant Management Group|Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient's perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy.
328073|NCT01177553|P1|Participant Flow|Surgery Group|"Patients randomized to surgery will have hospital arrangements (laboratory tests and anesthesia assessment) finalized for a surgery the next day. Patients will sign the informed consent form.~Patients undergoing surgery will be admitted to Tampa General Hospital and will complete usual hospital admission procedures."
328074|NCT01177553|O2|Outcome|Expectant Management Group|Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient's perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy.
328075|NCT01177553|O1|Outcome|Surgery Group|"Patients randomized to surgery will have hospital arrangements (laboratory tests and anesthesia assessment) finalized for a surgery the next day. Patients will sign the informed consent form.~Patients undergoing surgery will be admitted to Tampa General Hospital and will complete usual hospital admission procedures."
328076|NCT01177553|E2|Reported Event|Expectant Management Group|Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient's perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy.
328077|NCT01177553|E1|Reported Event|Surgery Group|"Patients randomized to surgery will have hospital arrangements (laboratory tests and anesthesia assessment) finalized for a surgery the next day. Patients will sign the informed consent form.~Patients undergoing surgery will be admitted to Tampa General Hospital and will complete usual hospital admission procedures."
328078|NCT01177410|B4|Baseline|Total|Total of all reporting groups
328079|NCT01177410|B3|Baseline|Placebo|Placebo : placebo capsules once daily for 12 weeks
328080|NCT01177410|B2|Baseline|Mesalamine Granules 750 mg|Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
328081|NCT01177410|B1|Baseline|Mesalamine Granules 1500 mg|Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
328082|NCT01177410|P3|Participant Flow|Placebo|Placebo : placebo capsules once daily for 12 weeks
328083|NCT01177410|P2|Participant Flow|Mesalamine Granules 750 mg|Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
328084|NCT01177410|P1|Participant Flow|Mesalamine Granules 1500 mg|Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
328085|NCT01177410|O3|Outcome|Placebo|Placebo : placebo capsules once daily for 12 weeks
328086|NCT01177410|O2|Outcome|Mesalamine Granules 750 mg|Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
328087|NCT01177410|O1|Outcome|Mesalamine Granules 1500 mg|Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
328088|NCT01177410|O3|Outcome|Placebo|Placebo : placebo capsules once daily for 12 weeks
328089|NCT01177410|O2|Outcome|Mesalamine Granules 750 mg|Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
328090|NCT01177410|O1|Outcome|Mesalamine Granules 1500 mg|Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
328091|NCT01177410|E3|Reported Event|Placebo|Placebo : placebo capsules once daily for 12 weeks
328092|NCT01177410|E2|Reported Event|Mesalamine Granules 750 mg|Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
328093|NCT01177410|E1|Reported Event|Mesalamine Granules 1500 mg|Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
328094|NCT01177384|B3|Baseline|Total|Total of all reporting groups
328095|NCT01177384|B2|Baseline|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
328096|NCT01177384|B1|Baseline|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
328097|NCT01177384|P2|Participant Flow|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
328098|NCT01177384|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
328099|NCT01177384|O2|Outcome|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
328100|NCT01177384|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
328101|NCT01177384|O2|Outcome|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
328102|NCT01177384|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
328103|NCT01177384|O2|Outcome|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
328104|NCT01177384|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
328105|NCT01177384|O2|Outcome|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
328106|NCT01177384|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
328107|NCT01177384|E2|Reported Event|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
328110|NCT01177293|P2|Participant Flow|Amlodipine ODT Then Amlodipine Capsule|Single oral dose amlodipine besylate 10 mg ODT in first intervention period and single oral dose of amlodipine besylate 10 mg capsule in second intervention period. A washout period of 14 days was maintained between each period.
328111|NCT01177293|P1|Participant Flow|Amlodipine Capsule Then Amlodipine ODT|Single oral dose amlodipine besylate 10 mg capsule in first intervention period and single oral dose of amlodipine besylate 10 mg oral disintegrating tablet (ODT) in second intervention period. A washout period of 14 days was maintained between each period.
328112|NCT01177293|O2|Outcome|Amlodipine 10 mg ODT|Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
328113|NCT01177293|O1|Outcome|Amlodipine 10 mg Capsule|Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
328114|NCT01177293|O2|Outcome|Amlodipine 10 mg ODT|Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
328115|NCT01177293|O1|Outcome|Amlodipine 10 mg Capsule|Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
328116|NCT01177293|O2|Outcome|Amlodipine 10 mg ODT|Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
328117|NCT01177293|O1|Outcome|Amlodipine 10 mg Capsule|Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
328118|NCT01177293|O2|Outcome|Amlodipine 10 mg ODT|Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
328119|NCT01177293|O1|Outcome|Amlodipine 10 mg Capsule|Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
328120|NCT01177293|O2|Outcome|Amlodipine 10 mg ODT|Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
328121|NCT01177293|O1|Outcome|Amlodipine 10 mg Capsule|Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
328122|NCT01177293|E2|Reported Event|Amlodipine 10 mg ODT|Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
328123|NCT01177293|E1|Reported Event|Amlodipine 10 mg Capsule|Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
328124|NCT01177228|B5|Baseline|Total|Total of all reporting groups
328125|NCT01177228|B4|Baseline|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
328126|NCT01177228|B3|Baseline|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg, IV infusion on Days 1, 15, 29 and 85.
328127|NCT01177228|B2|Baseline|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
328128|NCT01177228|B1|Baseline|Placebo|Vedolizumab-matching placebo, intravenous (IV), one 30-minute infusion on Days 1, 15, 29 and 85.
328129|NCT01177228|P4|Participant Flow|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg, IV infusion on Days 1, 15, 29 and 85.
328130|NCT01177228|P3|Participant Flow|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
328131|NCT01177228|P2|Participant Flow|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg, IV infusion on Days 1, 15, 29 and 85.
328132|NCT01177228|P1|Participant Flow|Placebo|Vedolizumab-matching placebo, intravenous (IV) infusion on Days 1, 15, 29 and 85.
328133|NCT01177228|O4|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
328134|NCT01177228|O3|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
328135|NCT01177228|O2|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
328136|NCT01177228|O1|Outcome|Placebo|Vedolizumab-matching placebo IV infusion on Days 1, 15, 29 and 85.
328137|NCT01177228|O4|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
328138|NCT01177228|O3|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
328139|NCT01177228|O2|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
328140|NCT01177228|O1|Outcome|Placebo|Vedolizumab-matching placebo IV infusion on Days 1, 15, 29 and 85.
328141|NCT01177228|O4|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
328142|NCT01177228|O3|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
328143|NCT01177228|O2|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
328144|NCT01177228|O1|Outcome|Placebo|Vedolizumab-matching placebo IV infusion on Days 1, 15, 29 and 85.
328145|NCT01177228|O4|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
328146|NCT01177228|O3|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
328147|NCT01177228|O2|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
328148|NCT01177228|O1|Outcome|Placebo|Vedolizumab-matching placebo IV infusion on Days 1, 15, 29 and 85.
328149|NCT01177228|O3|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
328150|NCT01177228|O2|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
328151|NCT01177228|O1|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
328152|NCT01177228|O3|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
328153|NCT01177228|O2|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
328154|NCT01177228|O1|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
328155|NCT01177228|O3|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
328156|NCT01177228|O2|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
328157|NCT01177228|O1|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
328158|NCT01177228|O3|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
328159|NCT01177228|O2|Outcome|Vedolizumab (6 mg/kg)|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
328160|NCT01177228|O1|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
328161|NCT01177228|O4|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
328162|NCT01177228|O3|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
328163|NCT01177228|O2|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
328167|NCT01177228|E2|Reported Event|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
328168|NCT01177228|E1|Reported Event|Placebo|Vedolizumab-matching placebo, intravenous (IV) infusion on Days 1, 15, 29 and 85.
328169|NCT01177098|B3|Baseline|Total|Total of all reporting groups
328170|NCT01177098|B2|Baseline|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
328171|NCT01177098|B1|Baseline|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
328172|NCT01177098|P2|Participant Flow|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
328173|NCT01177098|P1|Participant Flow|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
328174|NCT01177098|O2|Outcome|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
328175|NCT01177098|O1|Outcome|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
328176|NCT01177098|O2|Outcome|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
328177|NCT01177098|O1|Outcome|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
328178|NCT01177098|O2|Outcome|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
328179|NCT01177098|O1|Outcome|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
328180|NCT01177098|O2|Outcome|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
328181|NCT01177098|O1|Outcome|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
328182|NCT01177098|O2|Outcome|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
328183|NCT01177098|O1|Outcome|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
328184|NCT01177098|O2|Outcome|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
328185|NCT01177098|O1|Outcome|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
328186|NCT01177098|E2|Reported Event|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
328187|NCT01177098|E1|Reported Event|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
328188|NCT01177007|B1|Baseline|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
328189|NCT01177007|P1|Participant Flow|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
328190|NCT01177007|O1|Outcome|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
328201|NCT01176968|B2|Baseline|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
328202|NCT01176968|B1|Baseline|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
328203|NCT01176968|P2|Participant Flow|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
328191|NCT01177007|O1|Outcome|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
328192|NCT01177007|O1|Outcome|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
328193|NCT01177007|O1|Outcome|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
328194|NCT01177007|O1|Outcome|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
328195|NCT01177007|O1|Outcome|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
328196|NCT01177007|O1|Outcome|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time. A treatment may consist of a single 120 ± 10% Gy infusion to a lobe, or, if angiography indicates, the 120 ± 10% Gy dose may be split into multiple infusions per lobe to ensure delivery of a total of 120 ± 10% Gy to each treated lob
328197|NCT01177007|O1|Outcome|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
328198|NCT01177007|O1|Outcome|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time. A treatment may consist of a single 120 ± 10% Gy infusion to a lobe, or, if angiography indicates the need, the 120 ± 10% Gy dose may be split into multiple infusions per lobe to ensure delivery of a total of 120 ± 10% Gy to each tre
328199|NCT01177007|E1|Reported Event|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
328200|NCT01176968|B3|Baseline|Total|Total of all reporting groups
328204|NCT01176968|P1|Participant Flow|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
328205|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
328206|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
328207|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
328208|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
328209|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
328210|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
328211|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
328212|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
328213|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
328214|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
328215|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
328216|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
328217|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
328218|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
328219|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
328220|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
328221|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
328222|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
328223|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
328224|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
328225|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
328226|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
328227|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
328228|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
328229|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
328230|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
328231|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
328232|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
328233|NCT01176968|E2|Reported Event|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
328234|NCT01176968|E1|Reported Event|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
328235|NCT01176955|B3|Baseline|Total|Total of all reporting groups
328236|NCT01176955|B2|Baseline|Control|Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
328237|NCT01176955|B1|Baseline|Internet Survey|Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
328238|NCT01176955|P2|Participant Flow|Control|Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
328239|NCT01176955|P1|Participant Flow|Internet Survey|Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
328240|NCT01176955|O1|Outcome|All Participants|This group includes all participants in the study.
328241|NCT01176955|O2|Outcome|Control|Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
328242|NCT01176955|O1|Outcome|Internet Survey|Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
328243|NCT01176955|O2|Outcome|Control|Patients received standard-of-care therapy without weekly Internet surveys.
328244|NCT01176955|O1|Outcome|Internet Survey|Patients received a weekly Internet survey to report on the status of their acne.
328245|NCT01176955|O2|Outcome|Control|Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
328246|NCT01176955|O1|Outcome|Internet Survey|Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
328247|NCT01176955|E2|Reported Event|Control|Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
328248|NCT01176955|E1|Reported Event|Internet Survey|Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
328249|NCT01176877|B1|Baseline|Keloid Scar|Those with a diagnosis of keloid scar.
328250|NCT01176877|P1|Participant Flow|Keloid Scar|Subjects over the age of 18 with a clinical diagnosis of keloid scarring were included in the study. First, subjects completed a written questionnaire to collect demographic data, including personal history of keloid scarring, past and present use of keloid scar treatments, and internet access and use to find information related to keloid scars. Second, subjects completed a written questionnaire to assess knowledge about keloids. Next, subjects listened to a scripted, 5 minute educational lecture about keloid scars and then completed a written questionnaire to assess knowledge about keloids. Finally, subjects were contacted by phone 3 months later to complete a questionnaire to assess knowledge about keloids and to answer questions about keloid-related behaviors over the previous 3 months.
328251|NCT01176877|O1|Outcome|Keloid Scars|Participants with keloid scars completed a written questionnaire to assess knowledge about keloid scars. Participants then listened to a scripted, 5 minute educational lecture about keloid scars. 3 months after the educational lecture, subjects completed an identical verbal questionnaire to assess knowledge about keloid scars.
328252|NCT01176877|O1|Outcome|Keloid Scar|Participants with keloid scars completed a written questionnaire to assess knowledge about keloid scars. Participants then listened to a scripted, 5 minute educational lecture about keloid scars. Immediately after the educational lecture, the subjects completed an identical written questionnaire to assess knowledge about keloid scars.
328253|NCT01176877|E1|Reported Event|Keloid Scar|
328254|NCT01176773|B1|Baseline|Juvéderm® Ultra Lip Injectable Gel|
328255|NCT01176773|P1|Participant Flow|Juvéderm® Ultra Lip Injectable Gel|
328256|NCT01176773|O1|Outcome|Juvéderm® Ultra Lip Injectable Gel|
328257|NCT01176773|O1|Outcome|Juvéderm® Ultra Lip Injectable Gel|
328258|NCT01176773|O1|Outcome|Juvéderm® Ultra Lip Injectable Gel|
328259|NCT01176773|O1|Outcome|Juvéderm® Ultra Lip Injectable Gel|
328260|NCT01176773|O1|Outcome|Juvéderm® Ultra Lip Injectable Gel|
328261|NCT01176773|O1|Outcome|Juvéderm® Ultra Lip Injectable Gel|The Investigator determined the appropriate volume to inject based on clinical experience and the subject's cosmetic goals for lip enhancement.
328262|NCT01176773|E1|Reported Event|Juvéderm® Ultra Lip Injectable Gel|
328263|NCT01176617|B3|Baseline|Total|Total of all reporting groups
328264|NCT01176617|B2|Baseline|Reveal XT|"Subjects will be monitored using the conventional monitoring strategy for the first 6 months post-ablation. During the next 6 months, subjects will be monitored using the data from the Reveal device, transmitted from home every 30 days.~Reveal XT implantable loop recorder: All study participants will receive the Reveal XT implantable loop recorder immediately after completion of the ablation procedure."
328265|NCT01176617|B1|Baseline|Conventional Monitoring Strategy|Subjects will be monitored for 12 months using the conventional strategy which includes wearing a monitor over 3 separate 30-day periods over the first year post-ablation and daily pulse checks.
328266|NCT01176617|P3|Participant Flow|CM and Reveal XT|This was the non-randomized phase of the study in the first six months of evaluation.
328267|NCT01176617|P2|Participant Flow|Reveal XT|"Subjects will be monitored using the conventional monitoring strategy for the first 6 months post-ablation. During the next 6 months, subjects will be monitored using the data from the Reveal device, transmitted from home every 30 days.~Reveal XT implantable loop recorder: All study participants will receive the Reveal XT implantable loop recorder immediately after completion of the ablation procedure."
328268|NCT01176617|P1|Participant Flow|Conventional Monitoring Strategy|Subjects will be monitored for 12 months using the conventional strategy which includes wearing a monitor over 3 separate 30-day periods over the first year post-ablation and daily pulse checks.
328269|NCT01176617|O2|Outcome|Reveal XT|"Subjects will be monitored using the conventional monitoring strategy for the first 6 months post-ablation. During the next 6 months, subjects will be monitored using the data from the Reveal device, transmitted from home every 30 days.~Reveal XT implantable loop recorder: All study participants will receive the Reveal XT implantable loop recorder immediately after completion of the ablation procedure.~For details, please refer to the following citation of the published study: Kapa, et al, Journal of Cardiovascular Electrophysiology 2013; DOI:10.1111/JCE. 12141"
328270|NCT01176617|O1|Outcome|Conventional Monitoring Strategy|Subjects will be monitored for 12 months using the conventional strategy which includes wearing a monitor over 3 separate 30-day periods over the first year post-ablation and daily pulse checks.
328271|NCT01176617|O3|Outcome|Reveal XT and Conventional Monitoring|This was the non-randomized phase of the study in the first six months of evaluation.
328272|NCT01176617|O2|Outcome|Reveal XT|"Subjects will be monitored using the conventional monitoring strategy for the first 6 months post-ablation. During the next 6 months, subjects will be monitored using the data from the Reveal device, transmitted from home every 30 days.~Reveal XT implantable loop recorder: All study participants will receive the Reveal XT implantable loop recorder immediately after completion of the ablation procedure."
328273|NCT01176617|O1|Outcome|Conventional Monitoring Strategy|Subjects will be monitored for 12 months using the conventional strategy which includes wearing a monitor over 3 separate 30-day periods over the first year post-ablation and daily pulse checks.
328274|NCT01176617|E2|Reported Event|Reveal XT|"Subjects will be monitored using the conventional monitoring strategy for the first 6 months post-ablation. During the next 6 months, subjects will be monitored using the data from the Reveal device, transmitted from home every 30 days.~Reveal XT implantable loop recorder: All study participants will receive the Reveal XT implantable loop recorder immediately after completion of the ablation procedure."
328275|NCT01176617|E1|Reported Event|Conventional Monitoring Strategy|Subjects will be monitored for 12 months using the conventional strategy which includes wearing a monitor over 3 separate 30-day periods over the first year post-ablation and daily pulse checks.
328276|NCT01176565|B3|Baseline|Total|Total of all reporting groups
328277|NCT01176565|B2|Baseline|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
328278|NCT01176565|B1|Baseline|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
328279|NCT01176565|P2|Participant Flow|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
328280|NCT01176565|P1|Participant Flow|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater then the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
328281|NCT01176565|O2|Outcome|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
328332|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
328333|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
328334|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
328335|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
328336|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
328337|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
328338|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
328339|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
328340|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
328282|NCT01176565|O1|Outcome|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
328283|NCT01176565|O2|Outcome|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
328284|NCT01176565|O1|Outcome|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
328285|NCT01176565|O2|Outcome|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
328286|NCT01176565|O1|Outcome|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
328287|NCT01176565|O2|Outcome|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
328288|NCT01176565|O1|Outcome|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
328341|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
328342|NCT01176292|E2|Reported Event|Rotating Platform Cruciate Substituting TKA|
328343|NCT01176292|E1|Reported Event|Rotating Platform High-Flex Cruciate Substituting TKA|
328344|NCT01176266|B1|Baseline|Asfotase Alfa|A total of 6 mg/kg/week of asfotase alfa administered by SC injection (either 1 mg/kg asfotase alfa 6 times per week, or 2 mg/kg asfotase alfa 3 times per week)
328289|NCT01176565|O2|Outcome|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
328290|NCT01176565|O1|Outcome|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
328291|NCT01176565|O2|Outcome|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
328292|NCT01176565|O1|Outcome|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
328293|NCT01176565|O2|Outcome|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
328294|NCT01176565|O1|Outcome|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
328295|NCT01176565|E2|Reported Event|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
328345|NCT01176266|P1|Participant Flow|Asfotase Alfa|A total of 6 mg/kg/week of asfotase alfa administered by SC injection (either 1 mg/kg asfotase alfa 6 times per week, or 2 mg/kg asfotase alfa 3 times per week)
328346|NCT01176266|O1|Outcome|Asfotase Alfa|A total of 6 mg/kg/week of asfotase alfa administered by SC injection (2 mg/kg asfotase alfa 3 times per week)
328347|NCT01176266|O1|Outcome|Asfotase Alfa|A total of 6 mg/kg/week of asfotase alfa administered by SC injection (2 mg/kg asfotase alfa 3 times per week)
328296|NCT01176565|E1|Reported Event|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
328297|NCT01176513|B1|Baseline|GE 148-002|GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.
328298|NCT01176513|P1|Participant Flow|GE 148-002|GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.
328299|NCT01176513|O1|Outcome|GE 148-002|"GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.~Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons."
328300|NCT01176513|O1|Outcome|GE 148-002|"GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.~Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons."
328301|NCT01176513|E1|Reported Event|GE 148-002|"GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.~Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons."
328302|NCT01176448|B1|Baseline|Patients With Scars|12 individual scars on 6 patients were treated. Each scar was divided in half, and the halves randomized to either fractionated laser resurfacing or dermabrasion.
328303|NCT01176448|P1|Participant Flow|Patients With Scars|"12 long scars were recruited for individual study. Only 6 patients were needed as each patient had two separate scars to be studied. Each scar was divided in half, and the halves randomized to fractionated laser resurfacing or dermabrasion.~The half of the scar randomized to fractionated CO2 laser was treated first. The Re:Pair CO2 laser was used, with a fluence of 40 mJ and a treatment level of 8 (Solta Medical Inc., Hayward, CA). Four passes of the laser were used in total, with two in the orthogonal direction. A standard diamond fraise dermabrader was used on the area painted with gentian violet down through the dermal–epidermal junction. Dermabrasion was performed until a uniform area of punctate bleeding was obtained, and the edges were feathered into the surrounding epidermis."
328304|NCT01176448|O2|Outcome|Dermabrasion|Dermabrasion is the gold standard for scar resurfacing and will be used as the control against which Fractionated Laser is compared. 6 patients had 12 scars treated (2 scars per patient.
328305|NCT01176448|O1|Outcome|Fractionated Laser|This Arm is the section of scar that will be treated with Fractionated Laser. 6 patients had 12 scars treated (2 scars per patient.
328306|NCT01176448|O2|Outcome|Dermabrasion|Dermabrasion is the gold standard for scar resurfacing and will be used as the control against which Fractionated Laser is compared.
328307|NCT01176448|O1|Outcome|Fractionated Laser|This Arm is the section of scar that will be treated with Fractionated Laser
328308|NCT01176448|E2|Reported Event|Dermabrasion|Dermabrasion is the gold standard for scar resurfacing and will be used as the control against which Fractionated Laser is compared.
328309|NCT01176448|E1|Reported Event|Fractionated Laser|This Arm is the section of scar that will be treated with Fractionated Laser
328310|NCT01176435|B4|Baseline|Total|Total of all reporting groups
328311|NCT01176435|B3|Baseline|Placebo|"Solution taken orally three times a day.~Levodopa: Solution taken orally three times a day."
328312|NCT01176435|B2|Baseline|0.51 mg/kg L-DOPA|"Solution taken orally three times a day.~Levodopa: Solution taken orally three times a day."
328313|NCT01176435|B1|Baseline|0.76 mg/kg L-DOPA|"Solution taken orally three times a day.~Levodopa: Solution taken orally three times a day."
328314|NCT01176435|P3|Participant Flow|Placebo|"Solution taken orally three times a day.~Levodopa: Solution taken orally three times a day."
328315|NCT01176435|P2|Participant Flow|0.51 mg/kg L-DOPA|"Solution taken orally three times a day.~Levodopa: Solution taken orally three times a day."
328316|NCT01176435|P1|Participant Flow|0.76 mg/kg L-DOPA|"Solution taken orally three times a day.~Levodopa: Solution taken orally three times a day."
328317|NCT01176435|O3|Outcome|Placebo|"Solution taken orally three times a day.~Levodopa: Solution taken orally three times a day."
328318|NCT01176435|O2|Outcome|0.51 mg/kg L-DOPA|"Solution taken orally three times a day.~Levodopa: Solution taken orally three times a day."
328319|NCT01176435|O1|Outcome|0.76 mg/kg L-DOPA|"Solution taken orally three times a day.~Levodopa: Solution taken orally three times a day."
328320|NCT01176435|E3|Reported Event|Placebo|"Solution taken orally three times a day.~Levodopa: Solution taken orally three times a day."
328321|NCT01176435|E2|Reported Event|0.51 mg/kg L-DOPA|"Solution taken orally three times a day.~Levodopa: Solution taken orally three times a day."
328322|NCT01176435|E1|Reported Event|0.76 mg/kg L-DOPA|"Solution taken orally three times a day.~Levodopa: Solution taken orally three times a day."
328323|NCT01176292|B3|Baseline|Total|Total of all reporting groups
328324|NCT01176292|B2|Baseline|Rotating Platform Cruciate Substituting TKA|
328325|NCT01176292|B1|Baseline|Rotating Platform High-Flex Cruciate Substituting TKA|
328326|NCT01176292|P2|Participant Flow|Rotating Platform Cruciate Substituting TKA|
328327|NCT01176292|P1|Participant Flow|Rotating Platform High-Flex Cruciate Substituting TKA|
328328|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
328329|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
328330|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
328331|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
328348|NCT01176266|O1|Outcome|Asfotase Alfa|A total of 6 mg/kg/week of asfotase alfa administered by SC injection (2 mg/kg asfotase alfa 3 times per week)
328349|NCT01176266|O1|Outcome|Asfotase Alfa|A total of 6 mg/kg/week of asfotase alfa administered by SC injection (2 mg/kg asfotase alfa 3 times per week)
328350|NCT01176266|O1|Outcome|Asfotase Alfa|A total of 6 mg/kg/week of asfotase alfa administered by SC injection (either 1 mg/kg asfotase alfa 6 times per week, or 2 mg/kg asfotase alfa 3 times per week)
328351|NCT01176266|O1|Outcome|Asfotase Alfa|A total of 6 mg/kg/week of asfotase alfa administered by SC injection (either 1 mg/kg asfotase alfa 6 times per week, or 2 mg/kg asfotase alfa 3 times per week)
328352|NCT01176266|O1|Outcome|Asfotase Alfa|A total of 6 mg/kg/week of asfotase alfa administered by SC injection (either 1 mg/kg asfotase alfa 6 times per week, or 2 mg/kg asfotase alfa 3 times per week)
328353|NCT01176266|O1|Outcome|Asfotase Alfa|A total of 6 mg/kg/week of asfotase alfa administered by SC injection (either 1 mg/kg asfotase alfa 6 times per week, or 2 mg/kg asfotase alfa 3 times per week)
328354|NCT01176266|O1|Outcome|Asfotase Alfa|A total of 6 mg/kg/week of asfotase alfa administered by SC injection (either 1 mg/kg asfotase alfa 6 times per week, or 2 mg/kg asfotase alfa 3 times per week)
328355|NCT01176266|O1|Outcome|Asfotase Alfa|A total of 6 mg/kg/week of asfotase alfa administered by SC injection (either 1 mg/kg asfotase alfa 6 times per week, or 2 mg/kg asfotase alfa 3 times per week)
328356|NCT01176266|O3|Outcome|Asfotase Alfa - With Respiratory Support at Baseline|Results at End of Study for Those With Respiratory Support at Baseline (Last Assessment for Each Patient)
328357|NCT01176266|O2|Outcome|Asfotase Alfa - Without Respiratory Support at Baseline|Results at End of Study for Those Without Respiratory Support at Baseline (Last Assessment for Each Patient)
328358|NCT01176266|O1|Outcome|Baseline|Baseline assessment before initiation of asfotase alfa
328359|NCT01176266|O1|Outcome|Asfotase Alfa|A total of 6 mg/kg/week of asfotase alfa administered by SC injection (either 1 mg/kg asfotase alfa 6 times per week, or 2 mg/kg asfotase alfa 3 times per week)
328360|NCT01176266|O1|Outcome|Asfotase Alfa|A total of 6 mg/kg/week of asfotase alfa administered by SC injection (either 1 mg/kg asfotase alfa 6 times per week, or 2 mg/kg asfotase alfa 3 times per week)
328361|NCT01176266|O1|Outcome|Asfotase Alfa|A total of 6 mg/kg/week of asfotase alfa administered by SC injection (either 1 mg/kg asfotase alfa 6 times per week, or 2 mg/kg asfotase alfa 3 times per week)
328362|NCT01176266|O1|Outcome|Asfotase Alfa|A total of 6 mg/kg/week of asfotase alfa administered by SC injection (either 1 mg/kg asfotase alfa 6 times per week, or 2 mg/kg asfotase alfa 3 times per week)
328363|NCT01176266|E1|Reported Event|Asfotase Alfa|A total of 6 mg/kg/week of asfotase alfa administered by SC injection (either 1 mg/kg asfotase alfa 6 times per week, or 2 mg/kg asfotase alfa 3 times per week)
328364|NCT01176240|B5|Baseline|Total|Total of all reporting groups
328365|NCT01176240|B4|Baseline|Study 306B: Placebo|"Placebo matched control~Placebo: Placebo"
328366|NCT01176240|B3|Baseline|Study 306B: Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
328367|NCT01176240|B2|Baseline|Study 306A: Placebo|"Placebo matched control~Placebo: Placebo"
328368|NCT01176240|B1|Baseline|Study 306A: Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
328369|NCT01176240|P2|Participant Flow|Placebo|"Placebo matched control~Placebo: Placebo"
328370|NCT01176240|P1|Participant Flow|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
328371|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
328372|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
328373|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
328374|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
328375|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
328376|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
328377|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
328378|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
328379|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
328380|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
328381|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
328382|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
328383|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
328384|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
328385|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
328386|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
328387|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
328388|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
328389|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
328390|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
328391|NCT01176240|E2|Reported Event|Placebo|"Placebo matched control~Placebo: Placebo~Placebo Safety set excludes 3 patients randomized to placebo who were mistakenly dosed with droxidopa for short periods of time during the trial."
328720|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
328392|NCT01176240|E1|Reported Event|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment~Droxidopa Safety set includes 3 patients randomized to placebo who were mistakenly dosed with droxidopa for short periods of time during the trial."
328393|NCT01176058|B3|Baseline|Total|Total of all reporting groups
328394|NCT01176058|B2|Baseline|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
328395|NCT01176058|B1|Baseline|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
328396|NCT01176058|P2|Participant Flow|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant’s tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
328397|NCT01176058|P1|Participant Flow|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
328398|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
328399|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
328400|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
328401|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
328402|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
328403|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
328404|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
328405|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
328406|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
328407|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
328408|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
328409|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
328410|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
328411|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
328412|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
328413|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
328414|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
328415|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
328416|NCT01176058|E2|Reported Event|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
328417|NCT01176058|E1|Reported Event|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
328418|NCT01176032|B3|Baseline|Total|Total of all reporting groups
328419|NCT01176032|B2|Baseline|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
328420|NCT01176032|B1|Baseline|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
328421|NCT01176032|P2|Participant Flow|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
328422|NCT01176032|P1|Participant Flow|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
328423|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
328424|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
328425|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
328426|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
328427|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
328428|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
328429|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
328430|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
328431|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
328432|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
328433|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
328434|NCT01176032|O3|Outcome|Losartan|losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
328435|NCT01176032|O2|Outcome|Aliskiren + Amlodipinet|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
328436|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
328437|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
328438|NCT01176032|O3|Outcome|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
328439|NCT01176032|O2|Outcome|Aliskiren + Amlodipinet|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
328440|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
328441|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
328442|NCT01176032|O3|Outcome|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
328443|NCT01176032|O2|Outcome|Aliskiren + Amlodipinet|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
328444|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
328445|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
328446|NCT01176032|O3|Outcome|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
328447|NCT01176032|O2|Outcome|Aliskiren + Amlodipinet|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
328448|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
328449|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
328450|NCT01176032|O3|Outcome|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
328451|NCT01176032|O2|Outcome|Aliskiren + Amlodipinet|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
328452|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
328663|NCT01175590|B2|Baseline|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
328453|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
328454|NCT01176032|O3|Outcome|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
328455|NCT01176032|O2|Outcome|Aliskiren + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
328456|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
328457|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
328458|NCT01176032|O3|Outcome|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
328459|NCT01176032|O2|Outcome|Aliskiren + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
328460|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
328461|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
328462|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
328463|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
328464|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
328465|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
328466|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
328467|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
328468|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
328469|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
328470|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
328471|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
328472|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
328473|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
328474|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
328475|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
328476|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
328477|NCT01176032|E2|Reported Event|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
328478|NCT01176032|E1|Reported Event|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
328479|NCT01175902|B3|Baseline|Total|Total of all reporting groups
328480|NCT01175902|B2|Baseline|Dorzolamide/Timolol|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
328481|NCT01175902|B1|Baseline|Latanoprost|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
328482|NCT01175902|P2|Participant Flow|Dorzolamide/Timolol|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
328483|NCT01175902|P1|Participant Flow|Latanoprost|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
328484|NCT01175902|O2|Outcome|Dorzolamide/Timolol, Period 2|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
328485|NCT01175902|O1|Outcome|Latanoprost, Period 2|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
328486|NCT01175902|O2|Outcome|Dorzolamide/Timolol, Period 1|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
328487|NCT01175902|O1|Outcome|Latanoprost, Period 1|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
328488|NCT01175902|O2|Outcome|Dorzolamide/Timolol, Period 2|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
328489|NCT01175902|O1|Outcome|Latanoprost, Period 2|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
328490|NCT01175902|O2|Outcome|Dorzolamide/Timolol, Period 1|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
328491|NCT01175902|O1|Outcome|Latanoprost, Period 1|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
328492|NCT01175902|O2|Outcome|Dorzolamide/Timolol, Period 2|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
328493|NCT01175902|O1|Outcome|Latanoprost, Period 2|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
328494|NCT01175902|O2|Outcome|Dorzolamide/Timolol, Period 1|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
328495|NCT01175902|O1|Outcome|Latanoprost, Period 1|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
328496|NCT01175902|E2|Reported Event|Dorzolamide/Timolol|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
328497|NCT01175902|E1|Reported Event|Latanoprost|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
328498|NCT01175850|B3|Baseline|Total|Total of all reporting groups
328499|NCT01175850|B2|Baseline|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328500|NCT01175850|B1|Baseline|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328501|NCT01175850|P2|Participant Flow|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
328502|NCT01175850|P1|Participant Flow|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
328503|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328504|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328505|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328506|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328507|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328508|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328509|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328510|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328511|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328512|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328513|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328514|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328515|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328516|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328517|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328518|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328519|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328520|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328521|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328522|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328523|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328524|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328525|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328526|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328527|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328528|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328529|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328530|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328531|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328532|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328533|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328534|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328535|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
328536|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328537|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
328538|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328539|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328540|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
328541|NCT01175850|E2|Reported Event|Standard PTA|"Standard Percutaneous Transluminal Angioplasty (PTA) Balloon: Balloon Angioplasty~PTA Balloon: Balloon Angioplasty: balloon dilatation and provisional stenting with standard non-coated PTA balloon"
328542|NCT01175850|E1|Reported Event|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~Drug-Coated Balloon (DCB): balloon dilatation and provisional stenting with IN.PACT DCB"
328543|NCT01175824|B3|Baseline|Total|Total of all reporting groups
328544|NCT01175824|B2|Baseline|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
328545|NCT01175824|B1|Baseline|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
328546|NCT01175824|P2|Participant Flow|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
328547|NCT01175824|P1|Participant Flow|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
328548|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
328549|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
328550|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
328721|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
328551|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
328552|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
328553|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
328554|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
328555|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
328556|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
328557|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
328558|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
328559|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
328560|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
328561|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
328562|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
328563|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
328564|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
328565|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
328566|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
328567|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
328568|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
328569|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
328570|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
328571|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
328572|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
328573|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
328574|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
328575|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
328576|NCT01175824|E2|Reported Event|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
328577|NCT01175824|E1|Reported Event|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
328578|NCT01175811|B3|Baseline|Total|Total of all reporting groups
328579|NCT01175811|B2|Baseline|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
328580|NCT01175811|B1|Baseline|Premixed Insulin|"Twice daily (breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
328581|NCT01175811|P2|Participant Flow|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro~Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
328582|NCT01175811|P1|Participant Flow|Premixed Insulin|"Twice daily (breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
328583|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
328584|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
328585|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
328586|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
328587|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
328588|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
328589|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
328590|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
328591|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
328592|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
328593|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
328594|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
328595|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
328596|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
328597|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
328598|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
328599|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
328600|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
328601|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
328602|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
328603|NCT01175811|E2|Reported Event|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro~Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
328604|NCT01175811|E1|Reported Event|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
328605|NCT01175798|B3|Baseline|Total|Total of all reporting groups
328606|NCT01175798|B2|Baseline|Vitamin D Repletion|"Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).~Cholecalciferol: 50,000 IU PO weekly x 6 weeks"
328607|NCT01175798|B1|Baseline|No Treatment (Standard of Care)|Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).
328608|NCT01175798|P2|Participant Flow|Vitamin D Repletion|"Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).~Cholecalciferol: 50,000 IU PO weekly x 6 weeks"
328609|NCT01175798|P1|Participant Flow|No Treatment (Standard of Care)|Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).
328610|NCT01175798|O2|Outcome|Vitamin D Repletion|"Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).~Cholecalciferol: 50,000 IU PO weekly x 6 weeks"
328611|NCT01175798|O1|Outcome|No Treatment (Standard of Care)|Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).
328612|NCT01175798|E2|Reported Event|Vitamin D Repletion|"Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).~Cholecalciferol: 50,000 IU PO weekly x 6 weeks"
328613|NCT01175798|E1|Reported Event|No Treatment (Standard of Care)|Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).
328614|NCT01175707|B3|Baseline|Total|Total of all reporting groups
328615|NCT01175707|B2|Baseline|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
328616|NCT01175707|B1|Baseline|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
328617|NCT01175707|P2|Participant Flow|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
328618|NCT01175707|P1|Participant Flow|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
328619|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
328620|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
328621|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
328622|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
328623|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
328624|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
328625|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
328626|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
328627|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
328628|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
328629|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
328630|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
328631|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
328632|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
328664|NCT01175590|B1|Baseline|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
328633|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
328634|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
328635|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
328636|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
328637|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
328638|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted
328639|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
328640|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
328641|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
328642|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
328643|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
328644|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
328645|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
328646|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
328647|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
328648|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
328649|NCT01175707|E2|Reported Event|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
328650|NCT01175707|E1|Reported Event|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
328651|NCT01175668|B3|Baseline|Total|Total of all reporting groups
328652|NCT01175668|B2|Baseline|NMS/Phenobarbital|
328653|NCT01175668|B1|Baseline|NMS/Clonidine|
328654|NCT01175668|P2|Participant Flow|NMS/Phenobarbital|"Dosing was based on the Finnegan scores as below~Finn Score 8-10 NMS 0.32mg/kg/day +Phenobarbital 6 mg/kg/day 11-13 NMS 0.48 mg/kg/day +Phenobarbital 8 mg/kg/day 14-16 NMS 0.64 mg/kg/day +Phenobarbital 10 mg/kg/day ≥17 NMS 0.8 mg/kg/day* + Phenobarbital 12 mg/kg/day~Daily NMS dose was divided for q3h dosing interval Daily Phenobarbital dose was divided for q8h dosing interval~*If needing morphine sulfate > 0.8 mg/kg/day, increase dose in increments of 0.16 mg/kg/day until Finnegan score < 8"
328655|NCT01175668|P1|Participant Flow|NMS/Clonidine|"Dosing was based on the Finnegan scores as below~Finn Score 8-10 NMS 0.32mg/kg/day + Clonidine 6 mcg/kg/day 11-13 NMS 0.48 mg/kg/day + Clonidine 8 mcg/kg/day 14-16 NMS 0.64 mg/kg/day + Clonidine 10 mcg/kg/day ≥17 NMS 0.8 mg/kg/day* + Clonidine 12 mcg/kg/day~Daily NMS dose was divided for q3h dosing interval Daily Clonidine dose was divided for q6h dosing interval Clonidine escalation may be limited by hypotension or bradycardia~*If needing morphine sulfate > 0.8 mg/kg/day, increase dose in increments of 0.16 mg/kg/day until Finnegan score < 8"
328656|NCT01175668|O2|Outcome|NMS/Phenobarbital|
328657|NCT01175668|O1|Outcome|NMS/Clonidine|
328658|NCT01175668|O2|Outcome|NMS/Phenobarbital|
328659|NCT01175668|O1|Outcome|NMS/Clonidine|
328660|NCT01175668|E2|Reported Event|NMS/Phenobarbital|
328661|NCT01175668|E1|Reported Event|NMS/Clonidine|
328662|NCT01175590|B3|Baseline|Total|Total of all reporting groups
328665|NCT01175590|P2|Participant Flow|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
328666|NCT01175590|P1|Participant Flow|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
328667|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
328668|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
328669|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
328670|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
328671|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
328672|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
328673|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
328674|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
328675|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
328676|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
328677|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
328678|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
328679|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
328680|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
328681|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
328682|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
328683|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
328684|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
328685|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
328686|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
328687|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
328688|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
328689|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
328690|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
328691|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
328692|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
328693|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
328694|NCT01175590|O1|Outcome|Besivance|besifloxacin ophthalmic suspension 0.6% Besivance : Ocular administration to affected eye for 7 days
328695|NCT01175590|E2|Reported Event|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
328696|NCT01175590|E1|Reported Event|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
328697|NCT01175473|B3|Baseline|Total|Total of all reporting groups
328698|NCT01175473|B2|Baseline|Liraglutide|2-step initiation regimen of liraglutide: 0.6 mg QD subcutaneously for 1 week, followed by 1.2 mg QD for 1 week, then 1.8 mg QD up to Week 4.
328699|NCT01175473|B1|Baseline|Lixisenatide|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 4.
328700|NCT01175473|P2|Participant Flow|Liraglutide|2-step initiation regimen of liraglutide: 0.6 milligram (mg) QD subcutaneously for 1 week, followed by 1.2 mg QD for 1 week, then 1.8 mg QD up to Week 4.
328701|NCT01175473|P1|Participant Flow|Lixisenatide|1-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 4.
328702|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
328703|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
328704|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
328705|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
328706|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
328707|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
328708|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
328709|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
328710|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
328711|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
328712|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
328713|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
328714|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
328715|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
328716|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
328717|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
328722|NCT01175473|E2|Reported Event|Liraglutide|2-step initiation regimen of liraglutide.
328723|NCT01175473|E1|Reported Event|Lixisenatide|1-step initiation regimen of lixisenatide.
328724|NCT01175434|B3|Baseline|Total|Total of all reporting groups
328725|NCT01175434|B2|Baseline|Usual Care Group|Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians.
328726|NCT01175434|B1|Baseline|School-Based Medication Group|For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
328727|NCT01175434|P2|Participant Flow|Usual Care Group|Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians.
328728|NCT01175434|P1|Participant Flow|School-Based Medication Group|For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
328729|NCT01175434|O2|Outcome|Usual Care Group|Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians.
328730|NCT01175434|O1|Outcome|School-Based Medication Group|For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
328731|NCT01175434|E2|Reported Event|Usual Care Group|Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians.
328732|NCT01175434|E1|Reported Event|School-Based Medication Group|For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
328733|NCT01175395|B1|Baseline|IBI-20089/Lucentis|"Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis~IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results."
328734|NCT01175395|P1|Participant Flow|IBI-20089/Lucentis|"Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis~IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results."
328735|NCT01175395|O1|Outcome|IBI-20089/Lucentis|"Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis~IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results."
328736|NCT01175395|O1|Outcome|IBI-20089/Lucentis|"Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis~IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results."
328737|NCT01175395|E1|Reported Event|IBI-20089/Lucentis|"Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis~IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results."
328738|NCT01175382|B4|Baseline|Total|Total of all reporting groups
328739|NCT01175382|B3|Baseline|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328740|NCT01175382|B2|Baseline|Drug Therapy Alone|Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328821|NCT01175369|B2|Baseline|School-based Care|The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
328822|NCT01175369|B1|Baseline|Usual Care|Usual asthma care
328741|NCT01175382|B1|Baseline|Behavioral Treatment Alone|Behavioral treatment implemented in 4 clinic visits over a period of 6 weeks, followed by 6 weeks of combined behavioral + drug therapy. Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency, and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and daily bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies.
328742|NCT01175382|P3|Participant Flow|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328743|NCT01175382|P2|Participant Flow|Drug Therapy Alone|Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328744|NCT01175382|P1|Participant Flow|Behavioral Treatment Alone|Behavioral treatment implemented in 4 clinic visits over a period of 6 weeks, followed by 6 weeks of combined behavioral + drug therapy. Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency, and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and daily bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies.
328745|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328746|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
328747|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
328748|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328749|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
328750|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
328751|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328752|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
328849|NCT01175317|P1|Participant Flow|Goal-directed Fluid Optimization|Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
328753|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
328754|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328755|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
328756|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
328757|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328758|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
328759|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
328760|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328761|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
328762|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
328763|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328764|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
328765|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
328779|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
328766|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328767|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
328768|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
328769|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328770|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
328771|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
328772|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328773|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
328774|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
328775|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328776|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
328777|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
328778|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328850|NCT01175317|O2|Outcome|Regimen Based on Expertise Anaesthesist|Fluid regimen based on expertise anaesthesist
328780|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
328781|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328782|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
328783|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
328784|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328785|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
328786|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
328787|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328788|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
328789|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
328790|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328791|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
328792|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
328806|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
328793|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328794|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
328795|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
328796|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328797|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
328798|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
328799|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328800|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
328801|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
328802|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328803|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
328804|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
328805|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328944|NCT01175135|O4|Outcome|Placebo|Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
328807|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
328808|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328809|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
328810|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
328811|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328812|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
328813|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
328814|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328815|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
328816|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
328817|NCT01175382|E3|Reported Event|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328818|NCT01175382|E2|Reported Event|Drug Therapy Alone|Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
328819|NCT01175382|E1|Reported Event|Behavioral Treatment Alone|Behavioral treatment implemented in 4 clinic visits over a period of 6 weeks, followed by 6 weeks of combined behavioral + drug therapy. Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency, and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and daily bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies.
328820|NCT01175369|B3|Baseline|Total|Total of all reporting groups
329023|NCT01175018|P2|Participant Flow|Placebo|0.67 ml of sodium chloride (NaCl) 0.9% solution
328823|NCT01175369|P2|Participant Flow|School-based Care|The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
328824|NCT01175369|P1|Participant Flow|Usual Care|Usual asthma care
328825|NCT01175369|O2|Outcome|School-based Care|The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
328826|NCT01175369|O1|Outcome|Usual Care|Usual asthma care
328827|NCT01175369|E2|Reported Event|School-based Care|The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
328828|NCT01175369|E1|Reported Event|Usual Care|Usual asthma care
328829|NCT01175356|B1|Baseline|Treatment (131I-MIBG, Chemotherapy)|Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.
328830|NCT01175356|P1|Participant Flow|Treatment (131I-MIBG, Chemotherapy)|Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.
328831|NCT01175356|O1|Outcome|Treatment (131I-MIBG, Chemotherapy)|Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.
328832|NCT01175356|O1|Outcome|Treatment (131I-MIBG, Chemotherapy)|Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.
328833|NCT01175356|O1|Outcome|Treatment (131I-MIBG, Chemotherapy)|Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.
328834|NCT01175356|E1|Reported Event|Treatment (131I-MIBG, Chemotherapy)|Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.
328835|NCT01175343|B1|Baseline|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
328836|NCT01175343|P1|Participant Flow|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
328837|NCT01175343|O1|Outcome|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
328838|NCT01175343|O1|Outcome|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
328839|NCT01175343|O1|Outcome|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
328840|NCT01175343|O1|Outcome|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
328841|NCT01175343|O1|Outcome|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
328842|NCT01175343|O1|Outcome|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
328843|NCT01175343|O1|Outcome|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
328844|NCT01175343|E1|Reported Event|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
328845|NCT01175317|B3|Baseline|Total|Total of all reporting groups
328846|NCT01175317|B2|Baseline|Regimen Based on Expertise Anaesthesist|Fluid regimen based on expertise anaesthesist
328847|NCT01175317|B1|Baseline|Goald-directed Fluid Optimization|Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
328848|NCT01175317|P2|Participant Flow|Regimen Based on Expertise Anaesthesist|Fluid regimen based on expertise anaesthesist
328851|NCT01175317|O1|Outcome|Goal-directed Fluid Optimization|Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
328852|NCT01175317|O2|Outcome|Regimen Based on Expertise Anaesthesist|Fluid regimen based on expertise anaesthesist
328853|NCT01175317|O1|Outcome|Goal-directed Fluid Optimization|Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
328854|NCT01175317|E2|Reported Event|Regimen Based on Expertise Anaesthesist|Fluid regimen based on expertise anaesthesist
328855|NCT01175317|E1|Reported Event|Goal-directed Fluid Optimization|Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
328856|NCT01175226|B3|Baseline|Total|Total of all reporting groups
328857|NCT01175226|B2|Baseline|Placebo|Placebo: Placebo twice daily
328858|NCT01175226|B1|Baseline|BTA798|BTA798: BTA798 twice daily
328859|NCT01175226|P2|Participant Flow|Placebo|Placebo: Placebo twice daily
328860|NCT01175226|P1|Participant Flow|BTA798|BTA798: BTA798 twice daily
328861|NCT01175226|O2|Outcome|Placebo|Placebo: Placebo twice daily
328862|NCT01175226|O1|Outcome|BTA798|BTA798: BTA798 twice daily
328863|NCT01175226|E2|Reported Event|Placebo|Placebo: Placebo twice daily
328864|NCT01175226|E1|Reported Event|BTA798|BTA798: BTA798 twice daily
328865|NCT01175213|B5|Baseline|Total|Total of all reporting groups
328866|NCT01175213|B4|Baseline|Participants Aged 65 Years and Older|
328867|NCT01175213|B3|Baseline|Participants Aged 16 to <65 Years|
328868|NCT01175213|B2|Baseline|Participants Aged 12 to <16 Years|
328869|NCT01175213|B1|Baseline|Participants Aged 2 to <12 Years|
328870|NCT01175213|P2|Participant Flow|IGIV, 10% Only|"Participants were treated with Immune Globulin Intravenous (Human) (IGIV), 10% only, via the intravenous (IV) route throughout the study.~Note: IGIV, 10% is the same product as IGSC, 10%."
328871|NCT01175213|P1|Participant Flow|IGSC - rHuPH20 Then IGSC, 10% or IGIV, 10% Only|"Efficacy and safety of subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20). Participants then went into a safety follow-up with either SC administration of IGSC, 10% or intravenous (IV) administration of Immune Globulin Intravenous (Human) (IGIV), 10%, only. The IV or SC administration route was at the discretion of the participant and the investigator.~Note: IGIV, 10% is the same product as IGSC, 10%."
328872|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
328873|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
328874|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
328875|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
328876|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
328877|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
328878|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
328879|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
328880|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
328881|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
328882|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
328883|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
328884|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
328885|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
328886|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
328887|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
328888|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
328889|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
328890|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
328891|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
328892|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
328893|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
328894|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
328895|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
328945|NCT01175135|O3|Outcome|Risperidone 3 mg|Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.
328946|NCT01175135|O2|Outcome|PF-02545920 15 mg|Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
328947|NCT01175135|O1|Outcome|PF-02545920 5 mg|Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
328896|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
328897|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
328898|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
328899|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
328900|NCT01175213|O1|Outcome|All Participants Treated With rHuPH20|All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.
328901|NCT01175213|O1|Outcome|All Participants Treated With rHuPH20|All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.
328902|NCT01175213|O1|Outcome|All Participants Treated With rHuPH20|All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.
328903|NCT01175213|O1|Outcome|All Participants Treated With rHuPH20|All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.
328904|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
328905|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
328906|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
328907|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
328908|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
328909|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
328910|NCT01175213|O1|Outcome|All Participants Treated With rHuPH20 and/or IGSC, 10%|"All participants who had been exposed to either or both study drugs in the Safety Analysis Data Set. Study drugs are Immune Globulin Subcutaneous Solution, 10%, (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20).~This includes the 3 participants who received intravenous (IV) administration of IGSC, 10% without rHuPH20. The 3 participants were treated at 4-week intervals only.~Number of participants in each treatment interval [N] is provided."
328911|NCT01175213|O1|Outcome|All Participants Treated With IGSC, 10% and rHuPH20|"Participants treated with at least one dose of subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).~This does not include the 3 participants who received intravenous (IV) administration of IGSC, 10% without rHuPH20."
328912|NCT01175213|O1|Outcome|All Participants Treated With IGSC, 10% and rHuPH20|"Participants treated with at least one dose of subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).~This does not include the 3 participants who received intravenous (IV) administration of IGSC, 10% without rHuPH20."
328948|NCT01175135|O4|Outcome|Placebo|Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
328949|NCT01175135|O3|Outcome|Risperidone 3 mg|Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.
328950|NCT01175135|O2|Outcome|PF-02545920 15 mg|Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
328913|NCT01175213|E2|Reported Event|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
328914|NCT01175213|E1|Reported Event|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
328915|NCT01175148|B3|Baseline|Total|Total of all reporting groups
328916|NCT01175148|B2|Baseline|Donor Arm|Sibling donors will start taking atorvastatin orally at 40mg once daily between 14-28 days before the anticipated first day of apheresis or bone marrow harvest.
328917|NCT01175148|B1|Baseline|Recipient Arm|"Atorvastatin will be administered at dose of 40mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning. Patients will receive atorvastatin until +180 days or development of grade 2 GVHD.~Atorvastatin calcium (Lipitor): 40 mg PO daily"
328918|NCT01175148|P2|Participant Flow|Donor Arm|Sibling donors will start taking atorvastatin orally at 40mg once daily between 14-28 days before the anticipated first day of apheresis or bone marrow harvest.
328919|NCT01175148|P1|Participant Flow|Recipient Arm|"Atorvastatin will be administered at dose of 40mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning. Patients will receive atorvastatin until +180 days or development of grade 2 GVHD.~Atorvastatin calcium (Lipitor): 40 mg PO daily"
328920|NCT01175148|O1|Outcome|Recipient Arm - Experimental|"Atorvastatin will be administered at dose of 40mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning. Patients will receive atorvastatin until +180 days or development of grade 2 GVHD.~Atorvastatin calcium (Lipitor): 40 mg PO daily"
328921|NCT01175148|E2|Reported Event|Donor Arm|Sibling donors will start taking atorvastatin orally at 40mg once daily between 14-28 days before the anticipated first day of apheresis or bone marrow harvest.
328922|NCT01175148|E1|Reported Event|Recipient Arm - Experimental|"Atorvastatin will be administered at dose of 40mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning. Patients will receive atorvastatin until +180 days or development of grade 2 GVHD.~Atorvastatin calcium (Lipitor): 40 mg PO daily"
328923|NCT01175135|B5|Baseline|Total|Total of all reporting groups
328924|NCT01175135|B4|Baseline|Placebo|Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
328925|NCT01175135|B3|Baseline|Risperidone 3 mg|Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.
328926|NCT01175135|B2|Baseline|PF-02545920 15 mg|Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
328927|NCT01175135|B1|Baseline|PF-02545920 5 mg|Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
328928|NCT01175135|P4|Participant Flow|Placebo|Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
328929|NCT01175135|P3|Participant Flow|Risperidone 3 mg|Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.
328930|NCT01175135|P2|Participant Flow|PF-02545920 15 mg|Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
328931|NCT01175135|P1|Participant Flow|PF-02545920 5 mg|Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
328932|NCT01175135|O4|Outcome|Placebo|Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
328933|NCT01175135|O3|Outcome|Risperidone 3 mg|Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.
328934|NCT01175135|O2|Outcome|PF-02545920 15 mg|Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
328935|NCT01175135|O1|Outcome|PF-02545920 5 mg|Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
328936|NCT01175135|O4|Outcome|Placebo|Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
328937|NCT01175135|O3|Outcome|Risperidone 3 mg|Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.
328938|NCT01175135|O2|Outcome|PF-02545920 15 mg|Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
328939|NCT01175135|O1|Outcome|PF-02545920 5 mg|Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
328940|NCT01175135|O4|Outcome|Placebo|Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
328941|NCT01175135|O3|Outcome|Risperidone 3 mg|Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.
328942|NCT01175135|O2|Outcome|PF-02545920 15 mg|Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
328943|NCT01175135|O1|Outcome|PF-02545920 5 mg|Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
329021|NCT01175018|B2|Baseline|Placebo|0.67 ml of NaCl 0.9% solution
328951|NCT01175135|O1|Outcome|PF-02545920 5 mg|Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
328952|NCT01175135|O4|Outcome|Placebo|Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
328953|NCT01175135|O3|Outcome|Risperidone 3 mg|Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.
328954|NCT01175135|O2|Outcome|PF-02545920 15 mg|Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
328955|NCT01175135|O1|Outcome|PF-02545920 5 mg|Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
328956|NCT01175135|O4|Outcome|Placebo|Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
328957|NCT01175135|O3|Outcome|Risperidone 3 mg|Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.
328958|NCT01175135|O2|Outcome|PF-02545920 15 mg|Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
328959|NCT01175135|O1|Outcome|PF-02545920 5 mg|Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
328960|NCT01175135|O4|Outcome|Placebo|Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
328961|NCT01175135|O3|Outcome|Risperidone 3 mg|Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.
328962|NCT01175135|O2|Outcome|PF-02545920 15 mg|Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
328963|NCT01175135|O1|Outcome|PF-02545920 5 mg|Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
328964|NCT01175135|O4|Outcome|Placebo|Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
328965|NCT01175135|O3|Outcome|Risperidone 3 mg|Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.
328966|NCT01175135|O2|Outcome|PF-02545920 15 mg|Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
328967|NCT01175135|O1|Outcome|PF-02545920 5 mg|Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
328968|NCT01175135|O4|Outcome|Placebo|Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
328969|NCT01175135|O3|Outcome|Risperidone 3 mg|Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.
328970|NCT01175135|O2|Outcome|PF-02545920 15 mg|Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
328971|NCT01175135|O1|Outcome|PF-02545920 5 mg|Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
328972|NCT01175135|O4|Outcome|Placebo|Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
328973|NCT01175135|O3|Outcome|Risperidone 3 mg|Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.
328974|NCT01175135|O2|Outcome|PF-02545920 15 mg|Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
328975|NCT01175135|O1|Outcome|PF-02545920 5 mg|Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
328976|NCT01175135|O4|Outcome|Placebo|Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
328977|NCT01175135|O3|Outcome|Risperidone 3 mg|Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.
328978|NCT01175135|O2|Outcome|PF-02545920 15 mg|Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
328979|NCT01175135|O1|Outcome|PF-02545920 5 mg|Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
328980|NCT01175135|O4|Outcome|Placebo|Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
328981|NCT01175135|O3|Outcome|Risperidone 3 mg|Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.
328982|NCT01175135|O2|Outcome|PF-02545920 15 mg|Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
328983|NCT01175135|O1|Outcome|PF-02545920 5 mg|Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
328984|NCT01175135|O4|Outcome|Placebo|Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
328985|NCT01175135|O3|Outcome|Risperidone 3 mg|Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.
328986|NCT01175135|O2|Outcome|PF-02545920 15 mg|Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
328987|NCT01175135|O1|Outcome|PF-02545920 5 mg|Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
328988|NCT01175135|O4|Outcome|Placebo|Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
329022|NCT01175018|B1|Baseline|Anakinra|Anakinra 100 mg injectable subcutaneously daily
329092|NCT01174576|O3|Outcome|Water|200 mL
328989|NCT01175135|O3|Outcome|Risperidone 3 mg|Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.
328990|NCT01175135|O2|Outcome|PF-02545920 15 mg|Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
328991|NCT01175135|O1|Outcome|PF-02545920 5 mg|Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
328992|NCT01175135|O4|Outcome|Placebo|Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
328993|NCT01175135|O3|Outcome|Risperidone 3 mg|Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.
328994|NCT01175135|O2|Outcome|PF-02545920 15 mg|Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
328995|NCT01175135|O1|Outcome|PF-02545920 5 mg|Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
328996|NCT01175135|O4|Outcome|Placebo|Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
328997|NCT01175135|O3|Outcome|Risperidone 3 mg|Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.
328998|NCT01175135|O2|Outcome|PF-02545920 15 mg|Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
328999|NCT01175135|O1|Outcome|PF-02545920 5 mg|Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
329000|NCT01175135|O4|Outcome|Placebo|Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
329001|NCT01175135|O3|Outcome|Risperidone 3 mg|Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.
329002|NCT01175135|O2|Outcome|PF-02545920 15 mg|Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
329003|NCT01175135|O1|Outcome|PF-02545920 5 mg|Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
329004|NCT01175135|O4|Outcome|Placebo|Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
329005|NCT01175135|O3|Outcome|Risperidone 3 mg|Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.
329006|NCT01175135|O2|Outcome|PF-02545920 15 mg|Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
329007|NCT01175135|O1|Outcome|PF-02545920 5 mg|Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
329008|NCT01175135|E4|Reported Event|Placebo|Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
329009|NCT01175135|E3|Reported Event|Risperidone 3 mg|Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.
329010|NCT01175135|E2|Reported Event|PF-02545920 15 mg|Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
329011|NCT01175135|E1|Reported Event|PF-02545920 5 mg|Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
329012|NCT01175031|B1|Baseline|Sleep Apnea|Individuals with Obstructive Sleep Apnea (OSA); Complex Sleep Apnea (CompSAS) and central apnea index (CAI), or the PSG during PAP treatment had a central apnea index ≥ 5 events/h after obstructive apneas resolved.
329013|NCT01175031|P1|Participant Flow|Sleep Apnea|Individuals with Obstructive Sleep Apnea (OSA); Complex Sleep Apnea (CompSAS) and central apnea index (CAI), or the PSG during PAP treatment had a central apnea index ≥ 5 events/h after obstructive apneas resolved.
329014|NCT01175031|O1|Outcome|Device-Detected Clear Airway Apneas|Device-detected apneas were classified as either Clear Airway or Obstructed Airway.
329015|NCT01175031|O1|Outcome|Device-Detected Obstructive Airway Apneas|Of the device-detected obstructive airway apneas a comparison was done of manually scored verses device detected.
329016|NCT01175031|O1|Outcome|Device-Detected Apneas|Device-detected apneas were classified as either Clear Airway or Obstructed Airway.
329017|NCT01175031|O2|Outcome|Manually Scored Polysomnography (PSG)|"Manipulation of positive airway pressure (PAP) will occur throughout the night to induce breaking events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced, and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. Events will be measured with REMstar Auto with A-Flex and Manually Scored Polysomnography (PSG).~Manipulation of Positive Airway Pressure (PAP): Positive airway pressure (PAP) will be manipulated throughout the night to induce breathing events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced , and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. It will be measure by the REMstar Auto with A-Flex and manually scored PSG."
329018|NCT01175031|O1|Outcome|REMstar Auto With A-Flex|"Manipulation of positive airway pressure (PAP) will occur throughout the night to induce breaking events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced, and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. Events will be measured with REMstar Auto with A-Flex and Manually Scored Polysomnography (PSG).~Manipulation of Positive Airway Pressure (PAP): Positive airway pressure (PAP) will be manipulated throughout the night to induce breathing events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced , and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. It will be measure by the REMstar Auto with A-Flex and manually scored PSG."
329019|NCT01175031|E1|Reported Event|Subjects With Sleep Apnea|Subjects aged 21 thru 80 with a diagnosis of CompSAS or OSA and able to undergo a full-night in the sleep laboratory.
329020|NCT01175018|B3|Baseline|Total|Total of all reporting groups
329024|NCT01175018|P1|Participant Flow|Anakinra|Anakinra 100 mg injectable subcutaneously daily
329025|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
329026|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
329027|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
329028|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
329029|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
329030|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
329031|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
329032|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
329033|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
329034|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
329035|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
329036|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
329037|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
329038|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
329039|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
329040|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
329041|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
329042|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
329043|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
329044|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
329045|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
329046|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
329047|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
329048|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
329049|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
329050|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
329051|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
329052|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
329053|NCT01175018|O2|Outcome|Placebo|"0.67 ml of NaCl 0.9% solution~Placebo: 0.67 ml of NaCl 0.9% solution given subcutaneously daily for 14 days"
329054|NCT01175018|O1|Outcome|Anakinra|"Anakinra 100 mg injectable subcutaneously daily~Anakinra: Anakinra 100 mg s.c. daily for 14 days"
329055|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
329056|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
329057|NCT01175018|E2|Reported Event|Placebo|0.67 ml of NaCl 0.9% solution
329058|NCT01175018|E1|Reported Event|Anakinra|Anakinra 100 mg injectable subcutaneously daily
329059|NCT01175005|B1|Baseline|Fever and a Central Venous Catheter|
329060|NCT01175005|P1|Participant Flow|Fever and a Central Venous Catheter|
329061|NCT01175005|O2|Outcome|Blood Culture Negative|Procalcitonin level in patients with fever and a CVC with negative blood culture
329062|NCT01175005|O1|Outcome|Blood Culture Positive|Procalcitonin level in patients with fever and a CVC with positive blood culture
329063|NCT01175005|E1|Reported Event|Fever and a Central Venous Catheter|
329064|NCT01174784|B1|Baseline|Enrolled/Primary Cohort|
329065|NCT01174784|P1|Participant Flow|Enrolled/Primary Cohort|
329066|NCT01174784|O1|Outcome|Enrolled/Primary Cohort|
329067|NCT01174784|O1|Outcome|Enrolled/Primary Cohort|
329068|NCT01174784|E1|Reported Event|Enrolled/Primary Cohort|
329069|NCT01174576|B1|Baseline|Group 1|
329070|NCT01174576|P1|Participant Flow|Caffeinated Coffee/Decaffeinated Coffee/Water|"200 ml instant caffeinated coffee with 3 mg caffeine/kg body weight or instant decaffeinated coffee or water. All participants received all interventions without exception in a random order.~Three combinations of treatment sequences were used:~Caffeinated coffee, then decaffeinated coffee, then water~Decaffeinated coffee first, then water, then caffeinated coffee~Water first, then caffeinated coffee, then decaffeinated coffee.~Each treatment was separated by the other by at least one week interval.~The first volunteer entered the study received the first combination, the second volunteer the second combiation, the third volunteer the third combination, the forth volunteer the first combination of treatments, etc."
329071|NCT01174576|O3|Outcome|Water|200 mL
329072|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
329073|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
329074|NCT01174576|O3|Outcome|Water|200 mL
329075|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
329076|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
329077|NCT01174576|O3|Outcome|Water|200 mL
329078|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
329079|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
329080|NCT01174576|O3|Outcome|Water|200 ml water
329081|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 ml instant decaffeinated coffee
329082|NCT01174576|O1|Outcome|Caffeinated Coffee|200 ml instant caffeinated coffee with 3 mg caffeine/kg body weight
329083|NCT01174576|O3|Outcome|Water|200 mL
329084|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
329085|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/ kg body weight
329086|NCT01174576|O3|Outcome|Water|200 ml water
329087|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 ml instant decaffeinated coffee
329088|NCT01174576|O1|Outcome|Caffeinated Coffee|200 ml instant caffeinated coffee with 3 mg caffeine/kg body weight
329089|NCT01174576|O3|Outcome|Water|200 mL
329090|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
329091|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
329093|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeineated coffee
329094|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
329095|NCT01174576|O3|Outcome|Water|200 mL
329096|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
329097|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
329098|NCT01174576|O3|Outcome|Water|200 mL
329099|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
329100|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
329101|NCT01174576|O3|Outcome|Water|200 mL
329102|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
329103|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
329104|NCT01174576|O3|Outcome|Water|200 mL
329105|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
329106|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
329107|NCT01174576|E3|Reported Event|Water|200 mL
329108|NCT01174576|E2|Reported Event|Decaffeinated Coffee|200 mL decaffeinated coffee, same amount as caffeinated coffee
329109|NCT01174576|E1|Reported Event|Caffeinated Coffee|200 mL, coffee containing 3 mg caffeine/kg body weight
329110|NCT01174550|B3|Baseline|Total|Total of all reporting groups
329111|NCT01174550|B2|Baseline|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
329112|NCT01174550|B1|Baseline|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
329113|NCT01174550|P2|Participant Flow|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
329114|NCT01174550|P1|Participant Flow|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
329115|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
329116|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
329117|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
329118|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
329119|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
329120|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
329121|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
329122|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
329123|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
329124|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
329125|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
329126|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
329127|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
329128|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
329129|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
329130|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
329131|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
329132|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
329181|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
329133|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
329134|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
329135|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
329136|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
329137|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
329138|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
329139|NCT01174550|E2|Reported Event|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
329140|NCT01174550|E1|Reported Event|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
329141|NCT01174459|B1|Baseline|Patient With Restless Legs Syndrome|Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
329142|NCT01174459|P1|Participant Flow|Patient With Restless Legs Syndrome|Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
329143|NCT01174459|O1|Outcome|Patient With Restless Legs Syndrome|Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
329144|NCT01174459|O1|Outcome|Patient With Restless Legs Syndrome|Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
329145|NCT01174459|E1|Reported Event|Patient With Restless Legs Syndrome|Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
329146|NCT01174446|B1|Baseline|All Study Participants Who Received Study Drug|"BAX326 : -Study Part 1: Pharmacokinetic (PK) Crossover with BAX326 and BeneFIX~Study Part 2: Open-label evaluation of prophylaxis and on-demand BAX326 only~Study Part 3: Open-label repeat of PK evaluation (repeat Study Part 1) with BAX326 only and same study participants as Study Part 1"
329147|NCT01174446|P4|Participant Flow|Study Part 2 Only: BAX326 On-Demand|-Participants were only in Study Part 2 (i.e., did not participate in Study Parts 1 and 3)
329148|NCT01174446|P3|Participant Flow|Study Part 2 Only: BAX326 Prophylaxis|-Participants were only in Study Part 2 (i.e., did not participate in Study Parts 1 and 3)
329149|NCT01174446|P2|Participant Flow|PK (BeneFIX Then BAX326) Then Prophylaxis Then PK BAX326 Only|"Study Part 1: Pharmacokinetic (PK) Crossover with BeneFIX (75 ± 5 IU/kg) then BAX326 (75 ± 5 IU/kg).~Study Part 2: Open-label evaluation of prophylaxis and on-demand BAX326 only~Study Part 3: Open-label repeat of PK evaluation (repeat Study Part 1) with BAX326 (75 ± 5 IU/kg) only and same study participants as Study Part 1"
329150|NCT01174446|P1|Participant Flow|PK (BAX326 Then BeneFIX) Then Prophylaxis Then PK BAX326 Only|"Study Part 1: Pharmacokinetic (PK) Crossover with BAX326 (75 ± 5 IU/kg) then BeneFIX (75 ± 5 IU/kg).~Study Part 2: Open-label evaluation of prophylaxis and on-demand BAX326 only~Study Part 3: Open-label repeat of PK evaluation (repeat Study Part 1) with BAX326 (75 ± 5 IU/kg) only and same study participants as Study Part 1"
329151|NCT01174446|O2|Outcome|On-Demand|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
329152|NCT01174446|O1|Outcome|Prophylaxis|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
329153|NCT01174446|O2|Outcome|On-Demand|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
329154|NCT01174446|O1|Outcome|Prophylaxis|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
329182|NCT01174446|O5|Outcome|On-Demand: End of Study|
329210|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
329211|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
329212|NCT01174446|O5|Outcome|On-Demand: End of Study|
329550|NCT01173601|O3|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
329155|NCT01174446|O2|Outcome|On-Demand|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
329156|NCT01174446|O1|Outcome|Prophylaxis|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
329157|NCT01174446|O1|Outcome|Prophylaxis|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
329158|NCT01174446|O2|Outcome|On-Demand|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
329159|NCT01174446|O1|Outcome|Prophylaxis|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
329160|NCT01174446|O3|Outcome|Change From Baseline|
329161|NCT01174446|O2|Outcome|End of Study|
329162|NCT01174446|O1|Outcome|Part 1 or Part 2, Exposure Day 1 (Baseline)|
329163|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
329164|NCT01174446|O5|Outcome|On-Demand: End of Study|
329165|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
329166|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
329167|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
329168|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
329169|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
329170|NCT01174446|O5|Outcome|On-Demand: End of Study|
329171|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
329172|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
329173|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
329174|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
329175|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
329176|NCT01174446|O5|Outcome|On-Demand: End of Study|
329177|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
329178|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
329179|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
329180|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
329183|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
329184|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
329185|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
329186|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
329187|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
329188|NCT01174446|O5|Outcome|On-Demand: End of Study|
329189|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
329190|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
329191|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
329192|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
329193|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
329194|NCT01174446|O5|Outcome|On-Demand: End of Study|
329195|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day (ED) 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
329196|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
329197|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
329198|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day (ED) 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
329199|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
329200|NCT01174446|O5|Outcome|On-Demand: End of Study|
329201|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
329202|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
329203|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
329204|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
329205|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
329206|NCT01174446|O5|Outcome|On-Demand: End of Study|
329207|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
329208|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
329209|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
329213|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
329214|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
329215|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
329216|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
329217|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
329218|NCT01174446|O5|Outcome|On-Demand: End of Study|
329219|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
329220|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
329221|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
329222|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
329223|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
329224|NCT01174446|O5|Outcome|On-Demand: End of Study|
329225|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
329226|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
329227|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
329228|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
329229|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
329230|NCT01174446|O5|Outcome|On-Demand: End of Study|
329231|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
329232|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
329233|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
329234|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
329235|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
329236|NCT01174446|O5|Outcome|On-Demand: End of Study|
329237|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
329238|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
329239|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
329240|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
329241|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
329242|NCT01174446|O5|Outcome|On-Demand: End of Study|
329243|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
329244|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
329245|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
329246|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
329247|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
329248|NCT01174446|O5|Outcome|On-Demand: End of Study|
329249|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
329250|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
329251|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
329252|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
329253|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
329254|NCT01174446|O5|Outcome|On-Demand: End of Study|
329255|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
329256|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
329257|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
329258|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
329259|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
329260|NCT01174446|O5|Outcome|On-Demand: End of Study|
329261|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
329262|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
329263|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
329264|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
329265|NCT01174446|O2|Outcome|Participants With AEs - Related|"Probable, possible, or unknown causality assessment of an AE will be counted as related."
329266|NCT01174446|O1|Outcome|Participants With AEs - Not Related|
329267|NCT01174446|O2|Outcome|AEs - Related|"Probable, possible, or unknown causality assessment of an AE will be counted as related."
329268|NCT01174446|O1|Outcome|AEs - Not Related|
329269|NCT01174446|O1|Outcome|All Study Participants|
329270|NCT01174446|O1|Outcome|All Study Participants|
329271|NCT01174446|O1|Outcome|All Study Participants|
329272|NCT01174446|O1|Outcome|All Study Participants|
329273|NCT01174446|O1|Outcome|All Study Participants|
329274|NCT01174446|O1|Outcome|All Study Participants|
329275|NCT01174446|O1|Outcome|All Study Participants|
329282|NCT01174446|O2|Outcome|Bleeding Treatment|Includes all participants who received any infusions for bleeding treatment in the Full Analysis Set. (ie includes all On-demand arm (N=14) and 33 participants from the prophylaxis arm who experienced a bleeding episode)
329283|NCT01174446|O1|Outcome|Prophylactic Treatment|
329284|NCT01174446|O7|Outcome|Bleeding Cause: Unknown|
329285|NCT01174446|O6|Outcome|Bleeding Cause: Injury|
329286|NCT01174446|O5|Outcome|Bleeding Cause: Spontaneous|
329287|NCT01174446|O4|Outcome|Bleeding Site: Non-Joint|
329288|NCT01174446|O3|Outcome|Bleeding Site: All Joint|
329289|NCT01174446|O2|Outcome|Bleeding Site: Non-Target Joint|
329290|NCT01174446|O1|Outcome|Bleeding Site: Target Joint|
329291|NCT01174446|O7|Outcome|Bleeding Cause: Unknown|
329292|NCT01174446|O6|Outcome|Bleeding Cause: Injury|
329293|NCT01174446|O5|Outcome|Bleeding Cause: Spontaneous|
329294|NCT01174446|O4|Outcome|Bleeding Site: Non-Joint|
329295|NCT01174446|O3|Outcome|Bleeding Site: All Joint|
329296|NCT01174446|O2|Outcome|Bleeding Site: Non-Target Joint|
329297|NCT01174446|O1|Outcome|Bleeding Site: Target Joint|
329298|NCT01174446|O7|Outcome|Bleeding Cause: Unknown|
329299|NCT01174446|O6|Outcome|Bleeding Cause: Injury|
329300|NCT01174446|O5|Outcome|Bleeding Cause: Spontaneous|
329301|NCT01174446|O4|Outcome|Bleeding Site: Non-Joint|
329302|NCT01174446|O3|Outcome|Bleeding Site: All Joint|
329303|NCT01174446|O2|Outcome|Bleeding Site: Non-Target Joint|
329304|NCT01174446|O1|Outcome|Bleeding Site: Target Joint|
329305|NCT01174446|O1|Outcome|BAX326 Prophylaxis|"Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.~Participants received a minimum of three months prophylactic treatment"
329306|NCT01174446|O3|Outcome|Study Part 3: BAX326|"PK infusion with BAX326 at 75 ± 5 IU/kg~Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
329307|NCT01174446|O2|Outcome|Study Part 1: BeneFIX|PK infusion with BeneFIX at 75 ± 5 IU/kg
329308|NCT01174446|O1|Outcome|Study Part 1: BAX326|PK infusion with BAX326 at 75 ± 5 IU/kg
329309|NCT01174446|O3|Outcome|Study Part 3: BAX326|"PK infusion with BAX326 at 75 ± 5 IU/kg~Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
329310|NCT01174446|O2|Outcome|Study Part 1: BeneFIX|PK infusion with BeneFIX at 75 ± 5 IU/kg
329311|NCT01174446|O1|Outcome|Study Part 1: BAX326|PK infusion with BAX326 at 75 ± 5 IU/kg
329312|NCT01174446|O4|Outcome|Study Completion or Termination Visit|
329313|NCT01174446|O3|Outcome|Part 2 or Part 3: Week 26|
329314|NCT01174446|O2|Outcome|Part 2: Week 13|
329315|NCT01174446|O1|Outcome|Part 2: Week 5|PK infusion with BAX326 at 75 ± 5 IU/kg
329316|NCT01174446|O5|Outcome|Study Completion or Termination Visit|
329317|NCT01174446|O4|Outcome|Part 2 or Part 3: Week 26|
329318|NCT01174446|O3|Outcome|Part 2: Week 13|"PK infusion with BAX326 at 75 ± 5 IU/kg~Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
329319|NCT01174446|O2|Outcome|Part 2: Week 5|PK infusion with BeneFIX at 75 ± 5 IU/kg
329320|NCT01174446|O1|Outcome|Part 1 or Part 2, ED 1|PK infusion with BAX326 at 75 ± 5 IU/kg
329321|NCT01174446|O3|Outcome|Study Part 3: BAX326|"PK infusion with BAX326 at 75 ± 5 IU/kg~Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
329322|NCT01174446|O2|Outcome|Study Part 1: BeneFIX|PK infusion with BeneFIX at 75 ± 5 IU/kg
329323|NCT01174446|O1|Outcome|Study Part 1: BAX326|PK infusion with BAX326 at 75 ± 5 IU/kg
329324|NCT01174446|O3|Outcome|Study Part 3: BAX326|"PK infusion with BAX326 at 75 ± 5 IU/kg~Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
329325|NCT01174446|O2|Outcome|Study Part 1: BeneFIX|PK infusion with BeneFIX at 75 ± 5 IU/kg
329326|NCT01174446|O1|Outcome|Study Part 1: BAX326|PK infusion with BAX326 at 75 ± 5 IU/kg
329327|NCT01174446|O3|Outcome|Study Part 3: BAX326|"PK infusion with BAX326 at 75 ± 5 IU/kg~Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
329328|NCT01174446|O2|Outcome|Study Part 1: BeneFIX|PK infusion with BeneFIX at 75 ± 5 IU/kg
329329|NCT01174446|O1|Outcome|Study Part 1: BAX326|PK infusion with BAX326 at 75 ± 5 IU/kg
329330|NCT01174446|O3|Outcome|Study Part 3: BAX326|"PK infusion with BAX326 at 75 ± 5 IU/kg~Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
329331|NCT01174446|O2|Outcome|Study Part 1: BeneFIX|PK infusion with BeneFIX at 75 ± 5 IU/kg
329332|NCT01174446|O1|Outcome|Study Part 1: BAX326|PK infusion with BAX326 at 75 ± 5 IU/kg
329333|NCT01174446|O2|Outcome|BeneFIX|
329334|NCT01174446|O1|Outcome|BAX326|
329335|NCT01174446|E1|Reported Event|BAX326|"BAX326: -Study Part 1: Pharmacokinetic (PK) Crossover with BAX326 and BeneFIX~Study Part 2: Open-label evaluation of prophylaxis and on-demand BAX326 only~Study Part 3: Open-label repeat of PK evaluation (repeat Study Part 1) with BAX326 only and same study participants as Study Part 1"
329336|NCT01174342|B1|Baseline|Healthy Pregnant Women|Healthy pregnant women candidates for vaginal delivery.
329337|NCT01174342|P1|Participant Flow|Healthy Pregnant Women|Healthy pregnant women candidates for vaginal delivery.
329338|NCT01174342|O1|Outcome|Healthy Pregnant Women|Healthy pregnant women candidates for vaginal delivery
329339|NCT01174342|E1|Reported Event|Healthy Pregnant Women|Healthy pregnant women candidates for vaginal delivery.
329340|NCT01174264|B4|Baseline|Total|Total of all reporting groups
329341|NCT01174264|B3|Baseline|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose of vismodegib PO after eating a low fat meal. Beginning 7 days later, patients receive vismodegib PO after eating a meal daily on days 1-28.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329342|NCT01174264|B2|Baseline|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose of vismodegib PO after eating a high fat meal. Beginning 7 days later, patients receive vismodegib PO on an empty stomach daily on days 1-28.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329598|NCT01173471|B5|Baseline|Total|Total of all reporting groups
329343|NCT01174264|B1|Baseline|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose of vismodegib PO on an empty stomach. Beginning 7 days later, patients receive vismodegib PO on an empty stomach daily on days 1-28.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329344|NCT01174264|P3|Participant Flow|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329345|NCT01174264|P2|Participant Flow|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329346|NCT01174264|P1|Participant Flow|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329347|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329348|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329349|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329350|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329351|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329352|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329353|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329354|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329355|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329356|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329357|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329358|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329359|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329360|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329361|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329362|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329363|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329364|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329365|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329366|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329367|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329368|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329599|NCT01173471|B4|Baseline|AZD4017 400 mg BID|AZD4017 400 mg twice daily
329369|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329370|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329371|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329372|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329373|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329374|NCT01174264|E3|Reported Event|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329375|NCT01174264|E2|Reported Event|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329376|NCT01174264|E1|Reported Event|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
329377|NCT01174186|B3|Baseline|Total|Total of all reporting groups
329378|NCT01174186|B2|Baseline|Calprotectin Normal|"Spondylitis patients with active inflammation and normal calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week"
329379|NCT01174186|B1|Baseline|Calprotetin Elevated|"Spondylitis patients with active inflammation and elevated calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given"
329380|NCT01174186|P2|Participant Flow|Calprotectin Normal|"Spondylitis patients with active inflammation and normal calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week"
329381|NCT01174186|P1|Participant Flow|Calprotetin Elevated|"Spondylitis patients with active inflammation and elevated calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given"
329382|NCT01174186|O2|Outcome|Calprotectin Normal|"Spondylitis patients with active inflammation and normal calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week"
329383|NCT01174186|O1|Outcome|Calprotetin Elevated|"Spondylitis patients with active inflammation and elevated calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given"
329384|NCT01174186|O1|Outcome|Calprotetin Elevated|"Spondylitis patients with active inflammation and elevated calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given"
329385|NCT01174186|E2|Reported Event|Calprotectin Normal|"Spondylitis patients with active inflammation and normal calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week"
329386|NCT01174186|E1|Reported Event|Calprotetin Elevated|"Spondylitis patients with active inflammation and elevated calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given"
329387|NCT01174173|B1|Baseline|Ranolazine|"1000 mg PO BID~Ranolazine: ranolazine 1000 mg PO BID for 3 months"
329388|NCT01174173|P1|Participant Flow|Ranolazine|"1000 mg PO BID~Ranolazine: ranolazine 1000 mg PO BID for 3 months"
329389|NCT01174173|O1|Outcome|Ranolazine|"1000 mg PO BID~Ranolazine: ranolazine 1000 mg PO BID for 3 months"
329390|NCT01174173|O1|Outcome|Ranolazine|"1000 mg PO BID~Ranolazine: ranolazine 1000 mg PO BID for 3 months"
329391|NCT01174173|O1|Outcome|Ranolazine 1000 mg po Bid|MRI was not analyzable due to inability of patients to undergo MRI due to technical issues
329392|NCT01174173|O1|Outcome|Ranolazine|"1000 mg PO BID~Ranolazine: ranolazine 1000 mg PO BID for 3 months"
329393|NCT01174173|O1|Outcome|Ranolazine|"1000 mg PO BID~Ranolazine: ranolazine 1000 mg PO BID for 3 months"
329394|NCT01174173|O1|Outcome|Ranolazine|"1000 mg PO BID~Ranolazine: ranolazine 1000 mg PO BID for 3 months"
329395|NCT01174173|E1|Reported Event|Ranolazine|Ranolazine: ranolazine 1000 mg PO BID for 3 months
329396|NCT01174160|B3|Baseline|Total|Total of all reporting groups
329397|NCT01174160|B2|Baseline|Placebo|"placebo~Up to two 10-min infusions of normal saline"
329398|NCT01174160|B1|Baseline|Vernakalant IV|"vernakalant hydrochloride~Up to two 10-min infusions of 3mg/kg +/- 2mg/kg vernakalant IV"
329399|NCT01174160|P2|Participant Flow|Placebo|"placebo~Up to two 10-min infusions of normal saline"
329400|NCT01174160|P1|Participant Flow|Vernakalant IV|"vernakalant hydrochloride~Up to two 10-min infusions of 3mg/kg +/- 2mg/kg vernakalant IV"
329401|NCT01174160|O2|Outcome|Placebo|"placebo~Up to two 10-min infusions of normal saline"
329402|NCT01174160|O1|Outcome|Vernakalant IV|"vernakalant hydrochloride~Up to two 10-min infusions of 3mg/kg +/- 2mg/kg vernakalant IV"
329403|NCT01174160|E2|Reported Event|Placebo|"placebo~Up to two 10-min infusions of normal saline"
329404|NCT01174160|E1|Reported Event|Vernakalant IV|"vernakalant hydrochloride~Up to two 10-min infusions of 3mg/kg +/- 2mg/kg vernakalant IV"
329405|NCT01174043|B1|Baseline|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
329406|NCT01174043|P1|Participant Flow|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
329600|NCT01173471|B3|Baseline|Placebo BID|Placebo twice daily
329407|NCT01174043|O1|Outcome|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
329408|NCT01174043|O1|Outcome|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
329409|NCT01174043|O1|Outcome|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
329410|NCT01174043|E1|Reported Event|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
329411|NCT01174030|B6|Baseline|Total|Total of all reporting groups
329412|NCT01174030|B5|Baseline|Vehicle Gel BID|
329413|NCT01174030|B4|Baseline|Vehicle Gel QD|
329414|NCT01174030|B3|Baseline|CD07805/47 Gel 0.18% BID|
329415|NCT01174030|B2|Baseline|CD07805/47 Gel 0.18% QD|
329416|NCT01174030|B1|Baseline|CD07805/47 Gel 0.5% QD|
329417|NCT01174030|P5|Participant Flow|Vehicle Gel BID|Vehicle Gel Twice Daily
329418|NCT01174030|P4|Participant Flow|Vehicle Gel QD|Vehicle Gel Once Daily
329419|NCT01174030|P3|Participant Flow|CD07805/47 Gel 0.18% BID|CD07805/47 Gel 0.18% Twice Daily
329420|NCT01174030|P2|Participant Flow|CD07805/47 Gel 0.18% QD|CD07805/47 Gel 0.18% Once Daily
329421|NCT01174030|P1|Participant Flow|CD07805/47 Gel 0.5% QD|CD07805/47 Gel 0.5% Once Daily
329422|NCT01174030|O5|Outcome|Vehicle Gel BID|
329423|NCT01174030|O4|Outcome|Vehicle Gel QD|
329424|NCT01174030|O3|Outcome|CD07805/47 Gel 0.18% BID|
329425|NCT01174030|O2|Outcome|CD07805/47 Gel 0.18% QD|
329426|NCT01174030|O1|Outcome|CD07805/47 Gel 0.5% QD|
329427|NCT01174030|O5|Outcome|Vehicle Gel BID|
329428|NCT01174030|O4|Outcome|Vehicle Gel QD|
329429|NCT01174030|O3|Outcome|CD07805/47 Gel 0.18% BID|
329430|NCT01174030|O2|Outcome|CD07805/47 Gel 0.18% QD|
329431|NCT01174030|O1|Outcome|CD07805/47 Gel 0.5% QD|
329432|NCT01174030|O5|Outcome|Vehicle Gel BID|
329433|NCT01174030|O4|Outcome|Vehicle Gel QD|
329434|NCT01174030|O3|Outcome|CD07805/47 Gel 0.18% BID|
329435|NCT01174030|O2|Outcome|CD07805/47 Gel 0.18% QD|
329436|NCT01174030|O1|Outcome|CD07805/47 Gel 0.5% QD|
329437|NCT01174030|E5|Reported Event|Vehicle Gel BID|
329438|NCT01174030|E4|Reported Event|Vehicle Gel QD|
329439|NCT01174030|E3|Reported Event|CD07805/47 Gel 0.18% BID|
329440|NCT01174030|E2|Reported Event|CD07805/47 Gel 0.18% QD|
329441|NCT01174030|E1|Reported Event|CD07805/47 Gel 0.5% QD|
329442|NCT01174004|B3|Baseline|Total|Total of all reporting groups
329443|NCT01174004|B2|Baseline|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
329444|NCT01174004|B1|Baseline|Placebo|Placebo tablet, once daily by mouth, 6 weeks
329445|NCT01174004|P2|Participant Flow|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
329446|NCT01174004|P1|Participant Flow|Placebo|Placebo tablet, once daily by mouth, 6 weeks
329447|NCT01174004|O2|Outcome|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
329448|NCT01174004|O1|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
329449|NCT01174004|O2|Outcome|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
329450|NCT01174004|O1|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
329451|NCT01174004|E2|Reported Event|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
329452|NCT01174004|E1|Reported Event|Placebo|Placebo tablet, once daily by mouth, 6 weeks
329453|NCT01173874|B3|Baseline|Total|Total of all reporting groups
329454|NCT01173874|B2|Baseline|Cognitive Activity Control Group|This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
329455|NCT01173874|B1|Baseline|Cognitive Remediation|"Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.~Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving."
329456|NCT01173874|P2|Participant Flow|Cognitive Activity Control Group|This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
329457|NCT01173874|P1|Participant Flow|Cognitive Remediation|"Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.~Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving."
329458|NCT01173874|O2|Outcome|Cognitive Activity Control Group|This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
329476|NCT01173718|B1|Baseline|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
329601|NCT01173471|B2|Baseline|AZD4017 200 mg OD|AZD4017 200 mg once daily
329459|NCT01173874|O1|Outcome|Cognitive Remediation|"Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.~Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving."
329460|NCT01173874|O2|Outcome|Cognitive Activity Control Group|This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
329461|NCT01173874|O1|Outcome|Cognitive Remediation|"Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.~Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving."
329462|NCT01173874|O2|Outcome|Cognitive Activity Control Group|This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
329463|NCT01173874|O1|Outcome|Cognitive Remediation|"Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.~Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving."
329464|NCT01173874|O2|Outcome|Cognitive Activity Control Group|This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
329465|NCT01173874|O1|Outcome|Cognitive Remediation|"Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.~Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving."
329466|NCT01173874|E2|Reported Event|Cognitive Activity Control Group|This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
329467|NCT01173874|E1|Reported Event|Cognitive Remediation|"Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.~Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving."
329468|NCT01173848|B3|Baseline|Total|Total of all reporting groups
329469|NCT01173848|B2|Baseline|Vitamin D3|"Patient's randomized to take Vitamin D3~Cholecalciferol: 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months"
329470|NCT01173848|B1|Baseline|Vitamin D2|"Patients randomized to take vitamin D2~Ergocalciferol: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months"
329471|NCT01173848|P2|Participant Flow|Vitamin D3|"Patient's randomized to take Vitamin D3~Cholecalciferol: 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months"
329472|NCT01173848|P1|Participant Flow|Vitamin D2|"Patients randomized to take vitamin D2~Ergocalciferol: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months"
329473|NCT01173848|O2|Outcome|Vitamin D3|"Patient's randomized to take Vitamin D3~Cholecalciferol: 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months"
329474|NCT01173848|O1|Outcome|Vitamin D2|"Patients randomized to take vitamin D2~Ergocalciferol: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months"
329475|NCT01173848|E1|Reported Event|Vitamin D2 and Vitamin D3|"Adverse Events were not logged by study arms.~Patients randomized to take vitamin D2~Ergocalciferol: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months~or~Patient's randomized to take Vitamin D3~Cholecalciferol: 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months"
329602|NCT01173471|B1|Baseline|Placebo OD|Placebo once daily
329477|NCT01173718|P1|Participant Flow|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
329478|NCT01173718|O1|Outcome|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
329479|NCT01173718|O1|Outcome|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
329480|NCT01173718|O1|Outcome|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
329481|NCT01173718|O1|Outcome|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
329482|NCT01173718|O1|Outcome|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
329483|NCT01173718|O1|Outcome|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
329484|NCT01173718|E1|Reported Event|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft
329485|NCT01173679|B1|Baseline|Dasatinib, Rituximab, Fludarabine|"Single-arm~dasatinib: Taken orally once a day on days 1-14 of each 28-day cycle~Rituximab: Given intravenously, 375 mg/m2 each cycle (dose split, given on Days 3+4 of cycle 1, variable after that).~fludarabine: Given intravenously, 25 mg/m2/day, for 3 doses per cycle (Days 3-5 in cycle 1, Days 1-3 after that)"
329486|NCT01173679|P1|Participant Flow|Dasatinib, Rituximab, Fludarabine|"Single-arm~dasatinib: Taken orally once a day on days 1-14 of each 28-day cycle~Rituximab: Given intravenously, 375 mg/m2 each cycle (dose split, given on Days 3+4 of cycle 1, variable after that).~fludarabine: Given intravenously, 25 mg/m2/day, for 3 doses per cycle (Days 3-5 in cycle 1, Days 1-3 after that)"
329487|NCT01173679|O1|Outcome|Dasatinib, Rituximab, Fludarabine|"Single-arm~dasatinib: Taken orally once a day on days 1-14 of each 28-day cycle~Rituximab: Given intravenously, 375 mg/m2 each cycle (dose split, given on Days 3+4 of cycle 1, variable after that).~fludarabine: Given intravenously, 25 mg/m2/day, for 3 doses per cycle (Days 3-5 in cycle 1, Days 1-3 after that)"
329488|NCT01173679|O1|Outcome|Dasatinib, Rituximab, Fludarabine|"Single-arm~dasatinib: Taken orally once a day on days 1-14 of each 28-day cycle~Rituximab: Given intravenously, 375 mg/m2 each cycle (dose split, given on Days 3+4 of cycle 1, variable after that).~fludarabine: Given intravenously, 25 mg/m2/day, for 3 doses per cycle (Days 3-5 in cycle 1, Days 1-3 after that)"
329489|NCT01173679|O1|Outcome|Dasatinib, Rituximab, Fludarabine|"Single-arm, open-label~dasatinib: Taken orally once a day on days 1-14 of each 28-day cycle~Rituximab: Given intravenously, 375 mg/m2 each cycle (dose split, given on Days 3+4 of cycle 1, variable after that).~fludarabine: Given intravenously, 25 mg/m2/day, for 3 doses per cycle (Days 3-5 in cycle 1, Days 1-3 after that)"
329490|NCT01173679|E1|Reported Event|Dasatinib, Rituximab, Fludarabine|"Single-arm~dasatinib: Taken orally once a day on days 1-14 of each 28-day cycle~Rituximab: Given intravenously, 375 mg/m2 each cycle (dose split, given on Days 3+4 of cycle 1, variable after that).~fludarabine: Given intravenously, 25 mg/m2/day, for 3 doses per cycle (Days 3-5 in cycle 1, Days 1-3 after that)"
329491|NCT01173653|B3|Baseline|Total|Total of all reporting groups
329492|NCT01173653|B2|Baseline|Patients Contact 1-800-QUIT-NOW Before Leaving ED|Prior the patient leaving the ED, the PI will assist the patient with contacting 1-800-QUIT-NOW, who will help patient to quit smoking.
329493|NCT01173653|B1|Baseline|Standard EM Smoking Cessation Info|Patients discharged from ER receive pamphlet re: smoking cessation
329494|NCT01173653|P2|Participant Flow|Patients Contact 1-800-QUIT-NOW Before Leaving ED|Prior the patient leaving the ED, the PI will assist the patient with contacting 1-800-QUIT-NOW, who will help patient to quit smoking.
329495|NCT01173653|P1|Participant Flow|Standard EM Smoking Cessation Info|Patients discharged from ER receive pamphlet re: smoking cessation
329496|NCT01173653|O2|Outcome|Intervention Arm|Enrollees put in contact with 1-800-QUIT-NOW line
329497|NCT01173653|O1|Outcome|Control Arm|No intervention given to this ED population of smokers
329498|NCT01173653|E2|Reported Event|Patients Contact 1-800-QUIT-NOW Before Leaving ED|Prior the patient leaving the ED, the PI will assist the patient with contacting 1-800-QUIT-NOW, who will help patient to quit smoking.
329499|NCT01173653|E1|Reported Event|Standard EM Smoking Cessation Info|Patients discharged from ER receive pamphlet re: smoking cessation
329500|NCT01173601|B5|Baseline|Total|Total of all reporting groups
329501|NCT01173601|B4|Baseline|Placebo + SSRI (Non-Randomized Participants)|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
329502|NCT01173601|B3|Baseline|Placebo + SSRI (Randomized Participants)|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
329503|NCT01173601|B2|Baseline|18 mg LY2216684 + SSRI (Randomized Participants)|LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
329504|NCT01173601|B1|Baseline|12 mg LY2216684 + SSRI (Randomized Participants)|LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
329505|NCT01173601|P5|Participant Flow|Placebo + SSRI (Non-Randomized Participants)|Placebo: Administered orally, once daily for 8 weeks
329506|NCT01173601|P4|Participant Flow|Placebo + SSRI (Randomized Participants)|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
329507|NCT01173601|P3|Participant Flow|18 mg LY2216684 + SSRI (Randomized Participants)|LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
329508|NCT01173601|P2|Participant Flow|12 mg LY2216684 + SSRI (Randomized Participants)|LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a SSRI
329509|NCT01173601|P1|Participant Flow|Placebo + SSRI (Pre-Randomized Participants)|Placebo: Administered orally, once daily for 3 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
329549|NCT01173601|O1|Outcome|12 mg LY2216684 + SSRI|LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
329510|NCT01173601|O1|Outcome|LY2216684 + SSRI|LY2216684: fixed doses of 12 milligrams (mg) administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI) or 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
329511|NCT01173601|O3|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
329512|NCT01173601|O2|Outcome|18 mg LY2216684 + SSRI|LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
329513|NCT01173601|O1|Outcome|12 mg LY2216684 + SSRI|LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
329514|NCT01173601|O3|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
329515|NCT01173601|O2|Outcome|18 mg LY2216684 + SSRI|LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
329516|NCT01173601|O1|Outcome|12 mg LY2216684 + SSRI|LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
329517|NCT01173601|O3|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
329518|NCT01173601|O2|Outcome|18 mg LY2216684 + SSRI|LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
329519|NCT01173601|O1|Outcome|12 mg LY2216684 + SSRI|LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
329520|NCT01173601|O3|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
329521|NCT01173601|O2|Outcome|18 mg LY2216684 + SSRI|LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
329522|NCT01173601|O1|Outcome|12 mg LY2216684 + SSRI|LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
329523|NCT01173601|O3|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
329524|NCT01173601|O2|Outcome|18 mg LY2216684 + SSRI|LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
329525|NCT01173601|O1|Outcome|12 mg LY2216684 + SSRI|LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
329526|NCT01173601|O3|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
329527|NCT01173601|O2|Outcome|18 mg LY2216684 + SSRI|LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
329528|NCT01173601|O1|Outcome|12 mg LY2216684 + SSRI|LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
329529|NCT01173601|O3|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
329530|NCT01173601|O2|Outcome|18 mg LY2216684 + SSRI|LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
329531|NCT01173601|O1|Outcome|12 mg LY2216684 + SSRI|LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
329532|NCT01173601|O3|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
329533|NCT01173601|O2|Outcome|18 mg LY2216684 + SSRI|LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
329534|NCT01173601|O1|Outcome|12 mg LY2216684 + SSRI|LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
329535|NCT01173601|O3|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
329536|NCT01173601|O2|Outcome|18 mg LY2216684 + SSRI|LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
329537|NCT01173601|O1|Outcome|12 mg LY2216684 + SSRI|LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
329538|NCT01173601|O3|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
329539|NCT01173601|O2|Outcome|18 mg LY2216684 + SSRI|LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
329540|NCT01173601|O1|Outcome|12 mg LY2216684 + SSRI|LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
329541|NCT01173601|O3|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
329542|NCT01173601|O2|Outcome|18 mg LY2216684 + SSRI|LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
329543|NCT01173601|O1|Outcome|12 mg LY2216684 + SSRI|LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
329544|NCT01173601|O3|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
329545|NCT01173601|O2|Outcome|18 mg LY2216684 + SSRI|LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
329546|NCT01173601|O1|Outcome|12 mg LY2216684 + SSRI|LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
329547|NCT01173601|O3|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
329548|NCT01173601|O2|Outcome|18 mg LY2216684 + SSRI|LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
329551|NCT01173601|O2|Outcome|18 mg LY2216684 + SSRI|LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
329552|NCT01173601|O1|Outcome|12 mg LY2216684 + SSRI|LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
329553|NCT01173601|O3|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
329554|NCT01173601|O2|Outcome|18 mg LY2216684 + SSRI|LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
329555|NCT01173601|O1|Outcome|12 mg LY2216684 + SSRI|LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
329556|NCT01173601|O3|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
329557|NCT01173601|O2|Outcome|18 mg LY2216684 + SSRI|LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
329558|NCT01173601|O1|Outcome|12 mg LY2216684 + SSRI|LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
329559|NCT01173601|O3|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
329560|NCT01173601|O2|Outcome|18 mg LY2216684 + SSRI|LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
329561|NCT01173601|O1|Outcome|12 mg LY2216684 + SSRI|LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
329562|NCT01173601|O3|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
329563|NCT01173601|O2|Outcome|18 mg LY2216684 + SSRI|LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
329564|NCT01173601|O1|Outcome|12 mg LY2216684 + SSRI|LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
329565|NCT01173601|O3|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
329566|NCT01173601|O2|Outcome|18 mg LY2216684 + SSRI|LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
329567|NCT01173601|O1|Outcome|12 mg LY2216684 + SSRI|LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
329568|NCT01173601|O3|Outcome|Placebo + SSRI|Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
329569|NCT01173601|O2|Outcome|18 mg LY2216684 + SSRI|LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
329570|NCT01173601|O1|Outcome|12 mg LY2216684 + SSRI|LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
329571|NCT01173601|E12|Reported Event|Placebo + SSRI (Non-randomized) Discontinuation Phase|"Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI, during the adjunctive treatment phase.~Includes all non-randomized participants who discontinued placebo either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
329572|NCT01173601|E11|Reported Event|Placebo + SSRI (Randomized) Discontinuation Phase|"Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI, during the adjunctive treatment phase.~Includes all randomized participants who discontinued placebo either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
329573|NCT01173601|E10|Reported Event|18 mg LY2216684 + SSRI (Taper Discontinuation Phase)|"LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI, during the adjunctive treatment phase~Includes all randomized participants who tapered discontinuation of LY2216684 either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
329574|NCT01173601|E9|Reported Event|18 mg LY2216684 + SSRI (Abrupt Discontinuation Phase)|"LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI, during the adjunctive treatment phase~Includes all randomized participants who abruptly discontinued LY2216684 either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
329575|NCT01173601|E8|Reported Event|12 mg LY2216684 + SSRI (Taper Discontinuation Phase)|"LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a SSRI~Includes all randomized participants who tapered discontinuation of LY2216684 either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
329576|NCT01173601|E7|Reported Event|12 mg LY2216684 + SSRI (Abrupt Discontinuation Phase)|"LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a SSRI~Includes all randomized participants who abruptly discontinued LY2216684 either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
329577|NCT01173601|E6|Reported Event|Placebo + SSRI (Pre-randomized) Discontinuation Phase|"Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI, during the adjunctive treatment phase.~Includes all enrolled participants who abruptly discontinued placebo after early withdrawal during the Confirmation (CF) Phase and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit."
329578|NCT01173601|E5|Reported Event|Placebo + SSRI (Non-randomized) AT Phase|"Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI, during the adjunctive treatment phase.~Includes all non-randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase."
329603|NCT01173471|P4|Participant Flow|AZD4017 400 mg BID|AZD4017 400 mg twice daily
329579|NCT01173601|E4|Reported Event|Placebo + SSRI (Randomized) AT Phase|"Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI, during the adjunctive treatment phase~Includes randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase."
329580|NCT01173601|E3|Reported Event|18 mg LY2216684 + SSRI (Randomized) AT Phase|"LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI, during the adjunctive treatment phase.~Includes randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase."
329581|NCT01173601|E2|Reported Event|12 mg LY2216684 + SSRI (Randomized) AT Phase|"LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a SSRI, during the adjunctive treatment phase.~Includes randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase."
329582|NCT01173601|E1|Reported Event|Placebo + SSRI (Pre-randomized) CF Phase|"Placebo: Administered orally, once daily for 3 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)~Includes all enrolled participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-baseline visit during the Confirmation (CF) Phase."
329583|NCT01173523|B3|Baseline|Total|Total of all reporting groups
329584|NCT01173523|B2|Baseline|Cohort B: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.
329585|NCT01173523|B1|Baseline|Cohort A: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
329586|NCT01173523|P2|Participant Flow|Cohort B: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.
329587|NCT01173523|P1|Participant Flow|Cohort A: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
329588|NCT01173523|O2|Outcome|Cohort B: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.
329589|NCT01173523|O1|Outcome|Cohort A: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
329590|NCT01173523|O2|Outcome|Cohort B: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.
329591|NCT01173523|O1|Outcome|Cohort A: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
329592|NCT01173523|O2|Outcome|Cohort B: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.
329593|NCT01173523|O1|Outcome|Cohort A: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
329594|NCT01173523|O2|Outcome|Cohort B: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.
329595|NCT01173523|O1|Outcome|Cohort A: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
329596|NCT01173523|E2|Reported Event|Cohort B: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.
329597|NCT01173523|E1|Reported Event|Cohort A: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
329605|NCT01173471|P2|Participant Flow|AZD4017 200 mg OD|AZD4017 200 mg once daily
329606|NCT01173471|P1|Participant Flow|Placebo OD|Placebo once daily
329607|NCT01173471|O4|Outcome|AZD4017 400 mg BID|AZD4017 400 mg twice daily
329608|NCT01173471|O3|Outcome|Placebo BID|Placebo twice daily
329609|NCT01173471|O2|Outcome|AZD4017 200 mg OD|AZD4017 200 mg once daily
329610|NCT01173471|O1|Outcome|Placebo OD|Placebo once daily
329611|NCT01173471|O4|Outcome|AZD4017 400 mg BID|AZD4017 400 mg twice daily
329612|NCT01173471|O3|Outcome|Placebo BID|Placebo twice daily
329613|NCT01173471|O2|Outcome|AZD4017 200 mg OD|AZD4017 200 mg once daily
329614|NCT01173471|O1|Outcome|Placebo OD|Placebo once daily
329615|NCT01173471|O4|Outcome|AZD4017 400 mg BID|AZD4017 400 mg twice daily
329616|NCT01173471|O3|Outcome|Placebo BID|Placebo twice daily
329617|NCT01173471|O2|Outcome|AZD4017 200 mg OD|AZD4017 200 mg once daily
329618|NCT01173471|O1|Outcome|Placebo OD|Placebo once daily
329619|NCT01173471|E4|Reported Event|AZD4017 400 mg BID|AZD4017 400 mg twice daily
329620|NCT01173471|E3|Reported Event|Placebo BID|Placebo twice daily
329621|NCT01173471|E2|Reported Event|AZD4017 200 mg OD|AZD4017 200 mg once daily
329622|NCT01173471|E1|Reported Event|Placebo OD|Placebo once daily
329623|NCT01173211|B7|Baseline|Total|Total of all reporting groups
329624|NCT01173211|B6|Baseline|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329625|NCT01173211|B5|Baseline|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329626|NCT01173211|B4|Baseline|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329627|NCT01173211|B3|Baseline|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329628|NCT01173211|B2|Baseline|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329629|NCT01173211|B1|Baseline|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329630|NCT01173211|P6|Participant Flow|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329631|NCT01173211|P5|Participant Flow|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329632|NCT01173211|P4|Participant Flow|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329633|NCT01173211|P3|Participant Flow|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329634|NCT01173211|P2|Participant Flow|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329635|NCT01173211|P1|Participant Flow|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329636|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329637|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329638|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329639|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329640|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329641|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329642|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329643|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329644|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329645|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329646|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329647|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329648|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329649|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329650|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329651|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329652|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329653|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329654|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329655|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329656|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329657|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329658|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329659|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329660|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329661|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329662|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329663|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329664|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329665|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329666|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329667|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329668|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329669|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329670|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329671|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329672|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329673|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329674|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329675|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329676|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329677|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329678|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329679|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329680|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329681|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329682|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329683|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329684|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329685|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329686|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329687|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329688|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329689|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329690|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329691|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329692|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329693|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329694|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329695|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329696|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329697|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329698|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329699|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329700|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329701|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329702|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329703|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329704|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329705|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329706|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329707|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
330006|NCT01172847|O3|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
329708|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329709|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329710|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329711|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329712|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329713|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329714|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329715|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329716|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329717|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329718|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329719|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329720|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329721|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329722|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329723|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329724|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329725|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329726|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329727|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329728|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329729|NCT01173211|E6|Reported Event|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329730|NCT01173211|E5|Reported Event|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329731|NCT01173211|E4|Reported Event|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329732|NCT01173211|E3|Reported Event|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
329733|NCT01173211|E2|Reported Event|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
329734|NCT01173211|E1|Reported Event|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
329735|NCT01173120|B1|Baseline|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
329817|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329736|NCT01173120|P1|Participant Flow|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
329737|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
329738|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
329739|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
329740|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
329741|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
329742|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
329743|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
329744|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
329745|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
329746|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
329747|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous abatacept via the ACP for the duration of the substudy. Abatacept was administered subcutaneously using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a pre-filled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
329748|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
329749|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of SC abatacept via the ACP for the duration of the substudy. Abatacept was administered using the ACP by the participant or caregiver on Substudy SC on Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
329750|NCT01173120|E1|Reported Event|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
329751|NCT01173055|B3|Baseline|Total|Total of all reporting groups
330007|NCT01172847|O2|Outcome|Rimantadine|Participants received rimantadine 100 mg twice a day orally for 5 days.
329752|NCT01173055|B2|Baseline|Placebo First, Then Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
329753|NCT01173055|B1|Baseline|Milnacipran First, Then Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
329754|NCT01173055|P2|Participant Flow|Placebo First, Then Milnacipran|"Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo First, Then Milnacipran: Period 1 (Day 1-49); Placebo matching study treatment was administered beginning Period 1 (Day 1-49) and a 14 day washout period. Then, Milnacipran Period 2 (Day 64-112); Milnacipran 12.5mg Day 62; 12.5mg twice daily (BID) Day 65 to 66; 25mg BID Day 67 to 70; 50mg BID Day 71-77; 100mg BID Day 78-105 followed by taper Day 106-112."
329755|NCT01173055|P1|Participant Flow|Milnacipran First, Then Placebo|"Milnacipran then placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Milnacipran First, Then Placebo: Period 1 (Day 1-49); Milnacipran 12.5mg by mouth (PO) Day 1; 12.5mg twice daily (BID) Day 2 to 3; 25mg BID Day 4 to 7; 50mg BID Day 8-14; 100mg BID Day 15-42 followed by taper Day 43-49 and a 14 day washout period. Then, placebo matching study treatment in similar pattern to Period 1 was administered beginning Period 2 (Day 64-112)."
329756|NCT01173055|O2|Outcome|Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
329757|NCT01173055|O1|Outcome|Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
329758|NCT01173055|O2|Outcome|Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
329759|NCT01173055|O1|Outcome|Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
329760|NCT01173055|O2|Outcome|Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
329761|NCT01173055|O1|Outcome|Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
329762|NCT01173055|O2|Outcome|Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
329763|NCT01173055|O1|Outcome|Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
329764|NCT01173055|O2|Outcome|Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
329765|NCT01173055|O1|Outcome|Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
329766|NCT01173055|O2|Outcome|Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
329793|NCT01172938|B1|Baseline|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329767|NCT01173055|O1|Outcome|Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
329768|NCT01173055|E2|Reported Event|Placebo|Placebo was given orally twice daily in tablet form at different times during the course of the study.
329769|NCT01173055|E1|Reported Event|Milnacipran|Milnacipran was given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
329770|NCT01173029|B3|Baseline|Total|Total of all reporting groups
329771|NCT01173029|B2|Baseline|Pseudo-resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure <130 mmHg and mean 24h diastolic pressure <80mmHg) by non-investigation specialized hypertensive unit care, with appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
329772|NCT01173029|B1|Baseline|Resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure >/=130 mmHg and mean 24h diastolic pressure >/=80mmHg) by non-investigation specialized hypertensive unit care, in spite of appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
329773|NCT01173029|P2|Participant Flow|Pseudo-resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure <130 mmHg and mean 24h diastolic pressure <80mmHg) by non-investigation specialized hypertensive unit care, with appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
329774|NCT01173029|P1|Participant Flow|Resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure >/=130 mmHg and mean 24h diastolic pressure >/=80mmHg) by non-investigation specialized hypertensive unit care, in spite of appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
329775|NCT01173029|O9|Outcome|Polygenic Score: Eight|Sum of the weights for analyzing polymorphisms equal to eight.
329776|NCT01173029|O8|Outcome|Polygenic Score: Seven|Sum of the weights for analyzing polymorphisms equal to seven.
329777|NCT01173029|O7|Outcome|Polygenic Score: Six|Sum of the weights for analyzing polymorphisms equal to six.
329778|NCT01173029|O6|Outcome|Polygenic Score: Five|Sum of the weights for analyzing polymorphisms equal to five.
329779|NCT01173029|O5|Outcome|Polygenic Score: Four|Sum of the weights for analyzing polymorphisms equal to four.
329780|NCT01173029|O4|Outcome|Polygenic Score: Three|Sum of the weights for analyzing polymorphisms equal to three.
329781|NCT01173029|O3|Outcome|Polygenic Score: Two|Sum of the weights for analyzing polymorphisms equal to two.
329782|NCT01173029|O2|Outcome|Polygenic Score: One|Sum of the weights for analyzing polymorphisms equal to one.
329783|NCT01173029|O1|Outcome|Polygenic Score: Zero|Sum of the weights for analyzing polymorphisms equal to zero.
329784|NCT01173029|O2|Outcome|Pseudo-resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure <130 mmHg and mean 24h diastolic pressure <80mmHg) by non-investigation specialized hypertensive unit care, with appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
329785|NCT01173029|O1|Outcome|Resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure >/=130 mmHg and mean 24h diastolic pressure >/=80mmHg) by non-investigation specialized hypertensive unit care, in spite of appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
329786|NCT01173029|O2|Outcome|Pseudo-resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure <130 mmHg and mean 24h diastolic pressure <80mmHg) by non-investigation specialized hypertensive unit care, with appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
329787|NCT01173029|O1|Outcome|Resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure >/=130 mmHg and mean 24h diastolic pressure >/=80mmHg) by non-investigation specialized hypertensive unit care, in spite of appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
329788|NCT01173029|E2|Reported Event|Pseudo-resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure <130 mmHg and mean 24h diastolic pressure <80mmHg) by non-investigation specialized hypertensive unit care, with appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
329789|NCT01173029|E1|Reported Event|Resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure >/=130 mmHg and mean 24h diastolic pressure >/=80mmHg) by non-investigation specialized hypertensive unit care, in spite of appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
329790|NCT01172938|B4|Baseline|Total|Total of all reporting groups
329791|NCT01172938|B3|Baseline|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329792|NCT01172938|B2|Baseline|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329844|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
329794|NCT01172938|P9|Participant Flow|Placebo/Apremilast 30 mg (Long-Term Extension)|Participants initially randomized to placebo tablets BID during the placebo controlled phase and were re-randomized to apremilast 30 mg tablets BID at Week 16 or Week 24 and continued receiving apremilast 30 mg BID for up to 4.5 years in the active treatment / long-term safety phase.
329795|NCT01172938|P8|Participant Flow|Placebo/Apremilast 20 mg (Long-Term Extension)|Participants initially randomized to placebo tablets BID during the placebo controlled phase and were re-randomized to apremilast at Week 16 or Week 24 and continued receiving apremilast 20 mg BID for up to 4.5 years in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active participants originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose.
329796|NCT01172938|P7|Participant Flow|Placebo / Apremilast 30 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 to receive 30 mg apremilast for up to 4.5 years.
329797|NCT01172938|P6|Participant Flow|Placebo / Apremilast 30 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 30 mg apremilast for up to 4.5 years.
329798|NCT01172938|P5|Participant Flow|Placebo / Apremilast 20 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 (XO) to receive 20 mg apremilast for up to 4.5 years. After 30 mg apremilast BID was identified as the optimal dose, all active participants originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose for these participants.
329799|NCT01172938|P4|Participant Flow|Placebo / Apremilast 20 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 20 mg apremilast for up to 4.5 years. After 30 mg apremilast BID was identified as the optimal dose, all active participants originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose for these participants.
329800|NCT01172938|P3|Participant Flow|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329801|NCT01172938|P2|Participant Flow|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329802|NCT01172938|P1|Participant Flow|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329803|NCT01172938|O3|Outcome|Apremilast 30 mg BID|Participants who were treated with apremilast 30 mg BID throughout the study regardless of when their apremilast-exposure started (at Weeks 0, 16, or 24).
329804|NCT01172938|O2|Outcome|Apremilast 20 mg/30 mg BID (Post-switch)|Participants who switched from apremilast 20 mg BID to apremilast 30 mg BID. Only the TEAEs that occurred during APR 30 mg BID treatment were counted.
329805|NCT01172938|O1|Outcome|Apremilast 20 mg (Pre-switch)|Participants randomized or re-randomized to apremilast 20 mg BID and then switched to apremilast 30 mg BID (n = 87, dose switches occurring between Weeks 211 to 249). Only the TEAEs that occurred during apremilast 20 mg BID treatment were counted.
329806|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329807|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329808|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329809|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329810|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329811|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
329812|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
329813|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329814|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329815|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
329816|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
329818|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329819|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
329820|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
329821|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329822|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329823|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
329824|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
329825|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329826|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329827|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
329828|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
329829|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329830|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329831|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
329832|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
329833|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329834|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329835|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
329836|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
329837|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329838|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329839|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
329840|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
329841|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329842|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329843|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
329845|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329846|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329847|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
329848|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
329849|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329850|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329851|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
329852|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
329853|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329854|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329855|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
329856|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
329857|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329858|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329859|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
329860|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
329861|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329862|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329863|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
329864|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
329865|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329866|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329867|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
329868|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
329869|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329892|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329870|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329871|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
329872|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
329873|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329874|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329875|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
329876|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
329877|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329878|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329879|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329880|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329881|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329882|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329883|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329884|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329885|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329886|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329887|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329888|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329889|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329890|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329891|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
330005|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
329893|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329894|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329895|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329896|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329897|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329898|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329899|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329900|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329901|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329902|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329903|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329904|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329905|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329906|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329907|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329908|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329909|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329910|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329911|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329912|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329913|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329914|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329915|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329916|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329917|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329918|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329919|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329920|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329921|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329922|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329923|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329924|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329925|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329926|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329927|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329928|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329929|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329930|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329931|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329932|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329933|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329934|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329935|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329936|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329937|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329938|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329939|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329940|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329941|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329942|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329943|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329944|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329945|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329946|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329947|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329948|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329949|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329950|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329951|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329952|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329953|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329954|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329955|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329956|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329957|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329958|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329959|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329960|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329961|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329962|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329963|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329964|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329965|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329966|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329967|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329968|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329969|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329970|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329971|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329972|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329973|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329974|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329975|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329976|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the active treatment / long-term safety phase
329977|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast tablets twice daily (BID) in the placebo-controlled phase and continued to receive 20 mg apremilast tablets BID in the active treatment / long-term safety phase. After 30 mg apremilast BID was identified as the optimal dose, all active subjects originally receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose
329978|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
329979|NCT01172938|E6|Reported Event|Active Exposure up to 5 Years: Apremilast 30 mg BID|Subjects received 30 mg apremilast tablets BID at Week 0, and initially received placebo tablets BID during the placebo controlled phase and were re-randomized and received apremilast 30 mg at Week 16 or Week 24 and continued receiving apremilast 30 mg BID for up to 4.5 years in the active treatment / long-term safety phase.
329980|NCT01172938|E5|Reported Event|Active Exposure Up to 5 Years: Apremilast 20/30 mg BID|Subjects switched from apremilast 20 mg to apremilast 30 mg PO BID after identification of the optimal dose. Includes data which were occurring under 30 mg BID treatment
329981|NCT01172938|E4|Reported Event|Active Exposure up to 5 Years: Apremilast 20 mg|Subjects received 20 mg apremilast tablets BID at Week 0, and subjects initially received placebo tablets BID during the placebo controlled phase and were re-randomized and received apremilast 20 mg at Week 16 or Week 24 and continued to receive apremilast 20 mg BID for up to 4.5 years in the active treatment / long-term safety phase. Includes data which were occurring under 20 mg BID treatment.
329982|NCT01172938|E3|Reported Event|Week 0-24: Apremilast 30 mg (Placebo- Controlled Phase)|Subjects received 30 mg apremilast tablets PO BID during the 24-week placebo-controlled phase.
329983|NCT01172938|E2|Reported Event|Week 0-24: Apremilast 20 mg (Placebo- Controlled Phase)|Subjects received 20 mg apremilast tablets PO BID during the 24-week placebo-controlled phase.
329984|NCT01172938|E1|Reported Event|Week 0-24: Placebo (Placebo-Controlled Phase)|Subjects received placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for subjects who escaped early, and through Week 24 for all other subjects.
329985|NCT01172873|B3|Baseline|Total|Total of all reporting groups
329986|NCT01172873|B2|Baseline|E/RP Alone (no DCS Administration)|Five participants were enrolled in the second treatment arm as a comparison. The participants received 10 twice-weekly sessions of E/RP treatment alone.
329987|NCT01172873|B1|Baseline|D-cycloserine + E/RP|Participants in this treatment arm received 10 twice-weekly sessions of E/RP treatment and were administered D-Cycloserine (DCS) immediately after every treatment visit.
329988|NCT01172873|P2|Participant Flow|E/RP Alone (no DCS Administration)|The final 5 participants enrolled in the study were assigned to a second treatment arm, to compare E/RP alone to E/RP with D-Cycloserine. These participants received 10 twice-weekly sessions of E/RP without D-Cycloserine. DCS was not administered to this group during the active study period.
329989|NCT01172873|P1|Participant Flow|D-cycloserine + E/RP|The first 11 participants received 10 twice-weekly 60-minute sessions of exposure and response prevention (E/RP) during the active study period. D-Cycloserine 50 mg was administered immediately after each therapy session.
329990|NCT01172873|O2|Outcome|E/RP Alone (no DCS Administration)|Participants receiving 10 twice-weekly sessions of E/RP treatment alone. DCS was not administered to this group during the active study period.
329991|NCT01172873|O1|Outcome|D-cycloserine + E/RP|Treatment involved 10 twice-weekly 60-minute sessions of exposure and response prevention (E/RP) during the active study period. D-Cycloserine 50 mg was administered immediately after each therapy session.
329992|NCT01172873|O2|Outcome|E/RP Alone (no DCS Administration)|Participants receiving 10 twice-weekly sessions of E/RP treatment alone. DCS was not administered to this group during the active study period.
329993|NCT01172873|O1|Outcome|D-cycloserine + E/RP|Treatment involved 10 twice-weekly 60-minute sessions of exposure and response prevention (E/RP) during the active study period. D-Cycloserine 50 mg was administered immediately after each therapy session.
329994|NCT01172873|O2|Outcome|E/RP Alone (no DCS Administration)|Participants receiving 10 twice-weekly sessions of E/RP treatment alone. DCS was not administered to this group during the active study period.
329995|NCT01172873|O1|Outcome|D-cycloserine + E/RP|Treatment involved 10 twice-weekly 60-minute sessions of exposure and response prevention (E/RP) during the active study period. D-Cycloserine 50 mg was administered immediately after each therapy session.
329996|NCT01172873|E2|Reported Event|E/RP Alone (no DCS Administration)|Participants in this arm received twice-weekly 60 minute sessions of E/RP alone for a total of 10 sessions.
329997|NCT01172873|E1|Reported Event|D-cycloserine + E/RP|Participants in this arm receive 10 twice-weekly 60-minute sessions of Exposure and Response Prevention (E/RP) therapy and 50mg of D-Cycloserine immediately after each therapy session. D-Cycloserine is only administered on days in which therapy sessions are held.
329998|NCT01172847|B1|Baseline|Oseltamivir; Rimantadine; Oseltamivir + Rimantadine|Participants received treatments in 3 periods as: Oseltamivir 75 milligram [mg] (twice a day orally for 5 days), Rimantadine 100 mg (twice a day orally for 5 days), and Oseltamivir 75 mg + Rimantadine 100 mg (twice a day orally for 5 days) in a randomly determined sequence with a minimum 7-day wash out period between consecutive treatments periods.
329999|NCT01172847|P1|Participant Flow|Oseltamivir; Rimantadine; Oseltamivir + Rimantadine|Participants received treatments in 3 periods as: Oseltamivir 75 milligram [mg] (twice a day orally for 5 days), Rimantadine 100 mg (twice a day orally for 5 days), and Oseltamivir 75 mg + Rimantadine 100 mg (twice a day orally for 5 days) in a randomly determined sequence with a minimum 7-day wash out period between consecutive treatments periods.
330000|NCT01172847|O3|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
330001|NCT01172847|O2|Outcome|Rimantadine|Participants received rimantadine 100 mg twice a day orally for 5 days.
330002|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
330003|NCT01172847|O3|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
330004|NCT01172847|O2|Outcome|Rimantadine|Participants received rimantadine 100 mg twice a day orally for 5 days.
330008|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
330009|NCT01172847|O3|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
330010|NCT01172847|O2|Outcome|Rimantadine|Participants received rimantadine 100 mg twice a day orally for 5 days.
330011|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
330012|NCT01172847|O2|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
330013|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
330014|NCT01172847|O2|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
330015|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
330016|NCT01172847|O2|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
330017|NCT01172847|O1|Outcome|Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
330018|NCT01172847|O2|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
330019|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
330020|NCT01172847|E3|Reported Event|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
330021|NCT01172847|E2|Reported Event|Rimantadine|Participants received rimantadine 100 mg twice a day orally for 5 days.
330022|NCT01172847|E1|Reported Event|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
330023|NCT01172821|B5|Baseline|Total|Total of all reporting groups
330024|NCT01172821|B4|Baseline|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330025|NCT01172821|B3|Baseline|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330026|NCT01172821|B2|Baseline|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330027|NCT01172821|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330028|NCT01172821|P4|Participant Flow|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330029|NCT01172821|P3|Participant Flow|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330030|NCT01172821|P2|Participant Flow|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330031|NCT01172821|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330032|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330033|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330034|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330035|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330036|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330037|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330038|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330039|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330040|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330041|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330042|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330043|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330044|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330045|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330046|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330047|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330048|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330049|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330050|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330051|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330052|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330053|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330054|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330055|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330056|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330057|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330058|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330059|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330060|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330061|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330062|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330063|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330064|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330065|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330066|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330067|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330068|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330069|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330070|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330071|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330072|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330073|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330074|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330075|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330076|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330077|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330078|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330079|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330080|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330081|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330082|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330083|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330084|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330085|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330086|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330087|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330088|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330089|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330090|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330091|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330092|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330093|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330094|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330095|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330096|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330097|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330098|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330099|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330100|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330101|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330102|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330103|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330104|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330105|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330106|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330107|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330108|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330109|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330110|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330111|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330112|NCT01172821|E4|Reported Event|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330113|NCT01172821|E3|Reported Event|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330114|NCT01172821|E2|Reported Event|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330115|NCT01172821|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330116|NCT01172808|B5|Baseline|Total|Total of all reporting groups
330117|NCT01172808|B4|Baseline|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330118|NCT01172808|B3|Baseline|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330119|NCT01172808|B2|Baseline|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330120|NCT01172808|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330121|NCT01172808|P4|Participant Flow|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330122|NCT01172808|P3|Participant Flow|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330123|NCT01172808|P2|Participant Flow|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330124|NCT01172808|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330125|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330126|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330127|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330128|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330129|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330130|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330131|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330132|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330133|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330134|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330135|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330136|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330137|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330138|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330139|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330140|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330141|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330142|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330143|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330144|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330145|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330146|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330147|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330148|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330149|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330150|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330151|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330152|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330153|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330154|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330155|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330156|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330157|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330158|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330159|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330160|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330161|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330162|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330163|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330164|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330165|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330166|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330167|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330168|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330169|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330170|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330171|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330172|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330173|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330174|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330175|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330176|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330177|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330178|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330179|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330180|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330181|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330182|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330183|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330184|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330185|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330186|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330187|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330188|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330189|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330190|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330191|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330192|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330193|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330194|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330195|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330196|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330197|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330198|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330199|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330200|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330201|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330202|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330203|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330204|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330205|NCT01172808|E4|Reported Event|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330206|NCT01172808|E3|Reported Event|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
330207|NCT01172808|E2|Reported Event|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
330208|NCT01172808|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
330209|NCT01172600|B3|Baseline|Total|Total of all reporting groups
330210|NCT01172600|B2|Baseline|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330211|NCT01172600|B1|Baseline|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330212|NCT01172600|P2|Participant Flow|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330213|NCT01172600|P1|Participant Flow|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330214|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330215|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330216|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330217|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330218|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330219|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330220|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330221|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330222|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330223|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330224|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330225|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330226|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330227|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330228|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330229|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330230|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330231|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330232|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330233|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330234|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330235|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330236|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330237|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330238|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330239|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330240|NCT01172600|E2|Reported Event|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330241|NCT01172600|E1|Reported Event|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
330242|NCT01172535|B1|Baseline|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavirr, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
330243|NCT01172535|P1|Participant Flow|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
330244|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
330245|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
330246|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
330247|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
330248|NCT01172535|O3|Outcome|Week 24|Participants bringing medication to be measured at study week 24
330249|NCT01172535|O2|Outcome|Week 12|Participants bringing medication to be measured at study week 12
330250|NCT01172535|O1|Outcome|Week 4|Participants bringing medication to be measured at study week 4
330251|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
330252|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
330253|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
330254|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
330255|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
330256|NCT01172535|E1|Reported Event|LPV/r|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
330257|NCT01172522|B3|Baseline|Total|Total of all reporting groups
330258|NCT01172522|B2|Baseline|Fexofenadine Left Side; Placebo Right Side|"Topical treatment active versus placebo.~Double blind randomized placebo controlled split face intrasubject comparison.~Fexofenadine, placebo"
330259|NCT01172522|B1|Baseline|Fexofenadine Right Side; Placebo Left Side|"Topical treatment active versus placebo.~Double blind randomized placebo controlled split face intrasubject comparison.~Placebo, fexofenadine"
330260|NCT01172522|P2|Participant Flow|Fexofenadine Left Side; Placebo Right Side|Subjects were randomized as to side of face treated with test article versus placebo
330261|NCT01172522|P1|Participant Flow|Fexofenadine Right Side; Placebo Left Side|"Topical treatment active versus placebo.~Double blind randomized placebo controlled split face intrasubject comparison. Participants were randomized to side of face with active drug versus side of face with control, but with each treatment going on concurrently."
330262|NCT01172522|O2|Outcome|Placebo|All participants that received placebo
330263|NCT01172522|O1|Outcome|Fexofenadine|All participants that received fexofenadine
330456|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
330264|NCT01172522|E1|Reported Event|Split Face Intrasubject Comparison|"Topical treatment active versus placebo~Double blind randomized placebo controlled split face intrasubject comparison."
330265|NCT01172418|B3|Baseline|Total|Total of all reporting groups
330266|NCT01172418|B2|Baseline|Thymoglobulin and Alemtuzumab|"Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.~Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction."
330267|NCT01172418|B1|Baseline|Thymoglobulin and Daclizumab|"Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)~Daclizumab: used in combination with Thymoglobulin as combined induction"
330268|NCT01172418|P2|Participant Flow|Thymoglobulin and Alemtuzumab|"Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.~Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction."
330269|NCT01172418|P1|Participant Flow|Thymoglobulin and Daclizumab|"Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)~Daclizumab: used in combination with Thymoglobulin as combined induction"
330270|NCT01172418|O2|Outcome|Thymoglobulin and Alemtuzumab|
330271|NCT01172418|O1|Outcome|Thymoglobulin and Daclizumab|
330272|NCT01172418|O2|Outcome|Thymoglobulin and Alemtuzumab|
330273|NCT01172418|O1|Outcome|Thymoglobulin and Daclizumab|
330274|NCT01172418|O2|Outcome|Thymoglobulin and Alemtuzumab|
330275|NCT01172418|O1|Outcome|Thymoglobulin and Daclizumab|
330276|NCT01172418|O2|Outcome|Thymoglobulin and Alemtuzumab|
330277|NCT01172418|O1|Outcome|Thymoglobulin and Daclizumab|
330278|NCT01172418|O2|Outcome|Thymoglobulin and Alemtuzumab|"Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.~Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction."
330279|NCT01172418|O1|Outcome|Thymoglobulin and Daclizumab|"Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)~Daclizumab: used in combination with Thymoglobulin as combined induction"
330280|NCT01172418|E2|Reported Event|Thymoglobulin and Alemtuzumab|"Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.~Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction."
330281|NCT01172418|E1|Reported Event|Thymoglobulin and Daclizumab|"Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)~Daclizumab: used in combination with Thymoglobulin as combined induction"
330282|NCT01172353|B3|Baseline|Total|Total of all reporting groups
330283|NCT01172353|B2|Baseline|Saline|"hydration with saline 1ml/Kg/h for 6 hours~saline: hydration with saline 1ml/Kg/h for 6 hours"
330284|NCT01172353|B1|Baseline|Sodium Bicarbonate|"hydration with sodium bicarbonate~sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours"
330285|NCT01172353|P2|Participant Flow|Saline|"hydration with saline 1ml/Kg/h for 6 hours~saline: hydration with saline 1ml/Kg/h for 6 hours"
330286|NCT01172353|P1|Participant Flow|Sodium Bicarbonate|"hydration with sodium bicarbonate~sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours"
330287|NCT01172353|O2|Outcome|Saline|"hydration with saline 1ml/Kg/h for 6 hours~saline: hydration with saline 1ml/Kg/h for 6 hours"
330288|NCT01172353|O1|Outcome|Sodium Bicarbonate|"hydration with sodium bicarbonate~sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours"
330289|NCT01172353|O2|Outcome|Saline|"hydration with saline 1ml/Kg/h for 6 hours~saline: hydration with saline 1ml/Kg/h for 6 hours"
330290|NCT01172353|O1|Outcome|Sodium Bicarbonate|"hydration with sodium bicarbonate~sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours"
330291|NCT01172353|E2|Reported Event|Saline|"hydration with saline 1ml/Kg/h for 6 hours~saline: hydration with saline 1ml/Kg/h for 6 hours"
330292|NCT01172353|E1|Reported Event|Sodium Bicarbonate|"hydration with sodium bicarbonate~sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours"
330293|NCT01172288|B3|Baseline|Total|Total of all reporting groups
330294|NCT01172288|B2|Baseline|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
330295|NCT01172288|B1|Baseline|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
330296|NCT01172288|P2|Participant Flow|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
330297|NCT01172288|P1|Participant Flow|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
330298|NCT01172288|O2|Outcome|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
330299|NCT01172288|O1|Outcome|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
330300|NCT01172288|O2|Outcome|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
330301|NCT01172288|O1|Outcome|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
330302|NCT01172288|O2|Outcome|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
330303|NCT01172288|O1|Outcome|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
330304|NCT01172288|O2|Outcome|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
330305|NCT01172288|O1|Outcome|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
330306|NCT01172288|O2|Outcome|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
330307|NCT01172288|O1|Outcome|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
330308|NCT01172288|E2|Reported Event|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
330309|NCT01172288|E1|Reported Event|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
330310|NCT01172197|B3|Baseline|Total|Total of all reporting groups
330311|NCT01172197|B2|Baseline|Levobupivacaine|"Local anaesthetic bolus and infusion~Ropivacaine: Femoral bolus 150μM followed by femoral infusion 400μM"
330312|NCT01172197|B1|Baseline|Ropivacaine|"Local anaesthetic bolus and infusion~Levobupivacaine: Femoral bolus 150μM followed by femoral infusion 400μM"
330313|NCT01172197|P2|Participant Flow|Levobupivacaine|"Local anaesthetic bolus and infusion~Ropivacaine: Bolus and infusion"
330314|NCT01172197|P1|Participant Flow|Ropivacaine|"Local anaesthetic bolus and infusion~Levobupivacaine: Femoral bolus 150μM followed by femoral infusion 400μM"
330315|NCT01172197|O2|Outcome|Levobupivacaine|"Local anaesthetic bolus and infusion~Ropivacaine: Bolus and infusion"
330316|NCT01172197|O1|Outcome|Ropivacaine|"Local anaesthetic bolus and infusion~Levobupivacaine: Femoral bolus 150μM followed by femoral infusion 400μM"
330317|NCT01172197|E2|Reported Event|Levobupivacaine|"Local anaesthetic bolus and infusion~Ropivacaine: Bolus and infusion"
330318|NCT01172197|E1|Reported Event|Ropivacaine|"Local anaesthetic bolus and infusion~Levobupivacaine: Femoral bolus 150μM followed by femoral infusion 400μM"
330319|NCT01172184|B1|Baseline|Patients With Either Chronic or Acute Mitral Regurgitation|
330320|NCT01172184|P1|Participant Flow|Patients With Either Chronic or Acute Mitral Regurgitation|
330321|NCT01172184|O1|Outcome|Patients With Either Chronic or Acute Mitral Regurgitation|
330322|NCT01172184|O1|Outcome|Patients With Either Chronic or Acute Mitral Regurgitation|
330323|NCT01172184|O1|Outcome|Patients With Either Chronic or Acute Mitral Regurgitation|
330324|NCT01172184|E1|Reported Event|Patients With Either Chronic or Acute Mitral Regurgitation|
330325|NCT01172145|B3|Baseline|Total|Total of all reporting groups
330326|NCT01172145|B2|Baseline|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
330327|NCT01172145|B1|Baseline|Cholinesterase Inhibitor Only|participants who received placebo
330328|NCT01172145|P2|Participant Flow|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
330329|NCT01172145|P1|Participant Flow|Cholinesterase Inhibitor Only|participants who received placebo
330330|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
330331|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
330332|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
330333|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
330334|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
330335|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
330336|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
330337|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
330338|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
330339|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
330340|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
330341|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
330342|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
330343|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
330344|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
330345|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
330346|NCT01172145|E2|Reported Event|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
330347|NCT01172145|E1|Reported Event|Cholinesterase Inhibitor Only|participants who received placebo
330348|NCT01171989|B4|Baseline|Total|Total of all reporting groups
330457|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
330349|NCT01171989|B3|Baseline|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330350|NCT01171989|B2|Baseline|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330351|NCT01171989|B1|Baseline|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330352|NCT01171989|P3|Participant Flow|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330353|NCT01171989|P2|Participant Flow|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330354|NCT01171989|P1|Participant Flow|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330355|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330356|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330357|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330358|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330359|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330360|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330361|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330362|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330363|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330364|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330365|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330366|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330367|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330368|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330369|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330370|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330371|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330372|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330373|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330374|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330375|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330376|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330555|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330377|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330378|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330379|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330380|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330381|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330382|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330383|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330384|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330385|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330386|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330387|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330388|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330389|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330390|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330556|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330391|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330392|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330393|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330394|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330395|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330396|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330397|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330398|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330399|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330400|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330401|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330402|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330403|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330404|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330405|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330406|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330407|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330408|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330409|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330410|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330411|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330412|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330413|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330414|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330415|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330416|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330417|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330418|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330557|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330419|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330420|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330421|NCT01171989|E3|Reported Event|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330422|NCT01171989|E2|Reported Event|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330423|NCT01171989|E1|Reported Event|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
330424|NCT01171976|B4|Baseline|Total|Total of all reporting groups
330425|NCT01171976|B3|Baseline|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
330426|NCT01171976|B2|Baseline|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
330427|NCT01171976|B1|Baseline|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
330428|NCT01171976|P3|Participant Flow|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
330429|NCT01171976|P2|Participant Flow|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
330430|NCT01171976|P1|Participant Flow|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
330431|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
330432|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
330433|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
330434|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
330435|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
330436|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
330437|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
330438|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
330439|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
330440|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
330441|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
330442|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
330443|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
330444|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
330445|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
330446|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
330447|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
330448|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
330449|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
330450|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
330451|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
330452|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
330453|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
330454|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
330455|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
330458|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
330459|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
330460|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
330461|NCT01171976|E3|Reported Event|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
330462|NCT01171976|E2|Reported Event|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
330463|NCT01171976|E1|Reported Event|TE Ranibizumab 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
330464|NCT01171963|B3|Baseline|Total|Total of all reporting groups
330465|NCT01171963|B2|Baseline|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330466|NCT01171963|B1|Baseline|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330467|NCT01171963|P2|Participant Flow|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330468|NCT01171963|P1|Participant Flow|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330469|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330470|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330558|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330559|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330560|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330561|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330562|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330563|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330471|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330472|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330473|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330474|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330475|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330476|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330477|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330564|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330565|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330566|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330567|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330568|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330569|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330570|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330478|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330479|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330480|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330481|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330482|NCT01171963|O1|Outcome|Overall Study Arm|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330483|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330484|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330571|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330572|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330573|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330574|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330575|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330576|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330485|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330486|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330487|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330488|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330489|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330490|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330491|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330577|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330578|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330579|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330580|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330581|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330582|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330583|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330492|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330493|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330494|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330495|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330496|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330497|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330498|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330584|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330585|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330586|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330587|NCT01171820|E2|Reported Event|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330588|NCT01171820|E1|Reported Event|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330589|NCT01171794|B3|Baseline|Total|Total of all reporting groups
330590|NCT01171794|B2|Baseline|Placebo|Visually identical placebo
330499|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330500|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330501|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330502|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330503|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330504|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330505|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330591|NCT01171794|B1|Baseline|Ibuprofen|Ibuprofen : 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)
330592|NCT01171794|P2|Participant Flow|Placebo|Visually identical placebo
330593|NCT01171794|P1|Participant Flow|Ibuprofen|Ibuprofen : 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)
330594|NCT01171794|O2|Outcome|Placebo|visually identical placebo
330595|NCT01171794|O1|Outcome|Ibuprofen|Ibuprofen: 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)
330596|NCT01171794|O2|Outcome|Placebo|visually identical placebo
330597|NCT01171794|O1|Outcome|Ibuprofen|Ibuprofen: 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)
330506|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330507|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330508|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330509|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330510|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330511|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330512|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330598|NCT01171794|E2|Reported Event|Placebo|visually identical placebo
330599|NCT01171794|E1|Reported Event|Ibuprofen|Ibuprofen : 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)
330600|NCT01171690|B3|Baseline|Total|Total of all reporting groups
330601|NCT01171690|B2|Baseline|Control|These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
330513|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330514|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.Not Applicable
330515|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330516|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330517|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330518|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330519|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330602|NCT01171690|B1|Baseline|Teriparatide|The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.
330603|NCT01171690|P2|Participant Flow|Control|These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
330604|NCT01171690|P1|Participant Flow|Teriparatide|The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.
330520|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330521|NCT01171963|E2|Reported Event|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330522|NCT01171963|E1|Reported Event|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
330523|NCT01171924|B3|Baseline|Total|Total of all reporting groups
330524|NCT01171924|B2|Baseline|Arm B: 3 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.
330525|NCT01171924|B1|Baseline|Arm A: 5 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle.
330526|NCT01171924|P2|Participant Flow|Arm B: 3 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.
330527|NCT01171924|P1|Participant Flow|Arm A: 5 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle.
330528|NCT01171924|O2|Outcome|Arm B: 3 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.
330529|NCT01171924|O1|Outcome|Arm A: 5 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle.
330530|NCT01171924|E2|Reported Event|Arm B: 3 Days/Week|
330531|NCT01171924|E1|Reported Event|Arm A: 5 Days/Week|
330532|NCT01171820|B3|Baseline|Total|Total of all reporting groups
330533|NCT01171820|B2|Baseline|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330534|NCT01171820|B1|Baseline|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330535|NCT01171820|P2|Participant Flow|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during percutaneous coronary intervention (PCI)
330536|NCT01171820|P1|Participant Flow|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330537|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330538|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330539|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330540|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330541|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330542|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330543|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330544|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330545|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330546|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330547|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330548|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330549|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330550|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330551|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330552|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330553|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
330554|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
330605|NCT01171690|O2|Outcome|Control|These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
330606|NCT01171690|O1|Outcome|Teriparatide|The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.
330607|NCT01171690|O2|Outcome|Control|These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
330608|NCT01171690|O1|Outcome|Teriparatide|The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.
330609|NCT01171690|E2|Reported Event|Control|These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
330610|NCT01171690|E1|Reported Event|Teriparatide|"The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.~There were no adverse events related to the use of teriparatide."
330611|NCT01171677|B3|Baseline|Total|Total of all reporting groups
330612|NCT01171677|B2|Baseline|Treatment as Usual|
330613|NCT01171677|B1|Baseline|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
330614|NCT01171677|P2|Participant Flow|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
330615|NCT01171677|P1|Participant Flow|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
330616|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
330617|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
330618|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
330651|NCT01171612|O1|Outcome|Coronary Stent|Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery
330652|NCT01171612|O1|Outcome|Coronary Stent|Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery
330653|NCT01171612|E1|Reported Event|Cardiac and Cerebrovascular Events|Adverse events registered independently related with antiplatelet therapy management
330654|NCT01171534|B3|Baseline|Total|Total of all reporting groups
330619|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
330620|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
330621|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
330622|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
330623|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
330624|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
330625|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
330626|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
330627|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
330926|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
330628|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
330629|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
330630|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
330631|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
330632|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
330633|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
330634|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
330635|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
330636|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
332223|NCT01165983|O2|Outcome|T2DM Patients|
330637|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
330638|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
330639|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
330640|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
330641|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
330642|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
330643|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
330644|NCT01171677|E2|Reported Event|Treatment As Usual|
330645|NCT01171677|E1|Reported Event|Intensati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
330646|NCT01171612|B1|Baseline|Coronary Stent|Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery
330647|NCT01171612|P1|Participant Flow|Coronary Stent|Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery
330648|NCT01171612|O3|Outcome|Complete Withdrawal|patients with aspirin oand/or clopidogrel, which stopped therapy > 5 days
330649|NCT01171612|O2|Outcome|Incomplete Withdrawal (Mantaining ASA, Clopidogrel Withdrawn)|Patients under dual antiplatelet therapy, wich maintain aspirin, and withdrawn clopidogrel 5 or more days
330650|NCT01171612|O1|Outcome|Not Withdrawal Antiplatelet Therapy|Patients wiht aspirin and/or clopidogrel withdrawal for 5 or more days
330927|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
330655|NCT01171534|B2|Baseline|DermaClose Fasciotomy Closure|"Fasciotomy closure via DermaClose device~DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed."
330656|NCT01171534|B1|Baseline|Vessel Loop Fasciotomy Closure|"Fasciotomy closure using vessel loops and staples.~Vessel loop: Vessel loops and staples for fasciotomy closure"
330657|NCT01171534|P2|Participant Flow|DermaClose Fasciotomy Closure|"Fasciotomy closure via DermaClose device~DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed."
330658|NCT01171534|P1|Participant Flow|Vessel Loop Fasciotomy Closure|"Fasciotomy closure using vessel loops and staples.~Vessel loop: Vessel loops and staples for fasciotomy closure"
330659|NCT01171534|O2|Outcome|DermaClose Fasciotomy Closure|"Fasciotomy closure via DermaClose device~DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed."
330660|NCT01171534|O1|Outcome|Vessel Loop Fasciotomy Closure|"Fasciotomy closure using vessel loops and staples.~Vessel loop: Vessel loops and staples for fasciotomy closure"
330661|NCT01171534|O2|Outcome|DermaClose Fasciotomy Closure|"Fasciotomy closure via DermaClose device~DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed."
330662|NCT01171534|O1|Outcome|Vessel Loop Fasciotomy Closure|"Fasciotomy closure using vessel loops and staples.~Vessel loop: Vessel loops and staples for fasciotomy closure"
330663|NCT01171534|O2|Outcome|DermaClose Fasciotomy Closure|"Fasciotomy closure via DermaClose device~DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed."
330664|NCT01171534|O1|Outcome|Vessel Loop Fasciotomy Closure|"Fasciotomy closure using vessel loops and staples.~Vessel loop: Vessel loops and staples for fasciotomy closure"
330665|NCT01171534|O2|Outcome|DermaClose Fasciotomy Closure|"Fasciotomy closure via DermaClose device~DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed."
330666|NCT01171534|O1|Outcome|Vessel Loop Fasciotomy Closure|"Fasciotomy closure using vessel loops and staples.~Vessel loop: Vessel loops and staples for fasciotomy closure"
330667|NCT01171534|E2|Reported Event|DermaClose Fasciotomy Closure|"Fasciotomy closure via DermaClose device~DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed."
330668|NCT01171534|E1|Reported Event|Vessel Loop Fasciotomy Closure|"Fasciotomy closure using vessel loops and staples.~Vessel loop: Vessel loops and staples for fasciotomy closure"
330669|NCT01171521|B1|Baseline|DermaClose Group|"DermaClose device applied to complex soft-tissue wound, with or without negative pressure wound therapy, and prospectively followed for primary and secondary outcomes for one year.~DermaClose external tissue expander: The DermaClose external tissue expander provides continuous expanding of the skin around a wound until it has stretched enough to suture the wound edges closed."
330670|NCT01171521|P1|Participant Flow|DermaClose Group|"DermaClose device applied to complex soft-tissue wound, with or without negative pressure wound therapy, and prospectively followed for primary and secondary outcomes for one year.~DermaClose external tissue expander: The DermaClose external tissue expander provides continuous expanding of the skin around a wound until it has stretched enough to suture the wound edges closed."
330671|NCT01171521|O1|Outcome|DermaClose Group|"DermaClose device applied to complex soft-tissue wound, with or without negative pressure wound therapy, and prospectively followed for primary and secondary outcomes for one year.~DermaClose external tissue expander: The DermaClose external tissue expander provides continuous expanding of the skin around a wound until it has stretched enough to suture the wound edges closed."
330672|NCT01171521|O1|Outcome|DermaClose Group|"DermaClose device applied to complex soft-tissue wound, with or without negative pressure wound therapy, and prospectively followed for primary and secondary outcomes for one year.~DermaClose external tissue expander: The DermaClose external tissue expander provides continuous expanding of the skin around a wound until it has stretched enough to suture the wound edges closed."
330673|NCT01171521|E1|Reported Event|DermaClose Group|"DermaClose device applied to complex soft-tissue wound, with or without negative pressure wound therapy, and prospectively followed for primary and secondary outcomes for one year.~DermaClose external tissue expander: The DermaClose external tissue expander provides continuous expanding of the skin around a wound until it has stretched enough to suture the wound edges closed."
330674|NCT01171183|B3|Baseline|Total|Total of all reporting groups
330675|NCT01171183|B2|Baseline|Carvedilol Controlled Release|"controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing~controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper"
330676|NCT01171183|B1|Baseline|Placebo|Placebo: Placebo
330677|NCT01171183|P2|Participant Flow|Carvedilol Controlled Release|"controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing~controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper"
330678|NCT01171183|P1|Participant Flow|Placebo|Placebo: Placebo
330679|NCT01171183|O2|Outcome|Carvedilol Controlled Release|"controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing~controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper"
330680|NCT01171183|O1|Outcome|Placebo|Placebo: Placebo
330681|NCT01171183|O2|Outcome|Carvedilol Controlled Release|"controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing~controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper"
330682|NCT01171183|O1|Outcome|Placebo|Placebo: Placebo
330683|NCT01171183|E2|Reported Event|Carvedilol Controlled Release|"controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing~controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper"
330684|NCT01171183|E1|Reported Event|Placebo|Placebo: Placebo
330685|NCT01171118|B1|Baseline|Physostigmine/Placebo|Physostigmine (PS), a centrally-acting acetylcholinesterase inhibitor, is most commonly used by anesthesiologists in the post-anesthetic setting to reverse confusion caused by central anticholinergic medication effects. It has also been proposed as a treatment for sleep disordered breathing.We investigated whether PS was effective in decreasing the frequency of ventilatory arrhythmias (VA) produced during moderate sedation with midazolam and remifentanil in both room air (RA) and 2 l/m nasal O2. Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuouslyCapsaicin : 0.075% topical cream applicationPlacebo:We are attempting to demonstrate a decrease in the frequency and severity of sedation-induced respiratory arrhythmias (central and obstructive apneas) with pharmacological pre-treatment in this pilot project and then eventually to understand the mechanisms behind this.
330686|NCT01171118|P1|Participant Flow|Physostigmine vs. Placebo in Room Air vs. O2 During Sedation|"Each subject received the sedation protocol as described below:~Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Then, subjects were randomized to the specific order of each four arms. Physostigmine (PS) vs. Placebo were randomized by DAYS. Then, on each day, subjects were randomized to receive oxygen or room air first or second. But each subject went through BOTH days and both oxygen and room air on each day.~There were eight total possible sequences."
330687|NCT01171118|O4|Outcome|Placebo/Room Air|"Each subject received the sedation protocol as described below:~Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Then, subjects were randomized to the specific order of each four arms. Subjects breathed room air and received placebo instead of physostigimine in this arm."
330688|NCT01171118|O3|Outcome|Physostigmine/Room Air|"Each subject received the sedation protocol as described below:~Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Then, subjects were randomized to the specific order of each four arms. Subjects breathed room air and received placebo instead of physostigimine in this arm."
330689|NCT01171118|O2|Outcome|Placebo/Oxygen|Physostigmine (PS), a centrally-acting acetylcholinesterase inhibitor, is most commonly used by anesthesiologists in the post-anesthetic setting to reverse confusion caused by central anticholinergic medication effects. It has also been proposed as a treatment for sleep disordered breathing.We investigated whether PS was effective in decreasing the frequency of ventilatory arrhythmias (VA) produced during moderate sedation with midazolam and remifentanil in both room air (RA) and 2 l/m nasal O2. Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Capsaicin : 0.075% topical cream application Subjects were breathing oxygen via nasal cannula at 2 liters/minute
330690|NCT01171118|O1|Outcome|Physostigmine/Oxygen|Physostigmine (PS), a centrally-acting acetylcholinesterase inhibitor, is most commonly used by anesthesiologists in the post-anesthetic setting to reverse confusion caused by central anticholinergic medication effects. It has also been proposed as a treatment for sleep disordered breathing.We investigated whether PS was effective in decreasing the frequency of ventilatory arrhythmias (VA) produced during moderate sedation with midazolam and remifentanil in both room air (RA) and 2 l/m nasal O2. Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Capsaicin : 0.075% topical cream application Subjects were breathing oxygen via nasal cannula at 2 liters/minute
330691|NCT01171118|E4|Reported Event|Room Air|Subjects were assessed for two separate one hour periods of time -- one hour while breathing room air
330692|NCT01171118|E3|Reported Event|Oxygen|Subjects were assessed for two separate one hour periods of time -- one hour while breathing oxygen via a nasal cannula at 2 liters/minute
330693|NCT01171118|E2|Reported Event|Placebo|We are attempting to demonstrate a decrease in the frequency and severity of sedation-induced respiratory arrhythmias (central and obstructive apneas) with pharmacological pre-treatment in this pilot project and then eventually to understand the mechanisms behind this decrease. The efficacy and mechanisms of these treatments, while evaluated during sleep in OSA patients, have not been systematically studied during sedation in either normal subjects or OSA patients. The agent to be assessed in this study is physostigmine versus placebo.
330694|NCT01171118|E1|Reported Event|Physostigmine|Physostigmine (PS), a centrally-acting acetylcholinesterase inhibitor, is most commonly used by anesthesiologists in the post-anesthetic setting to reverse confusion caused by central anticholinergic medication effects. It has also been proposed as a treatment for sleep disordered breathing.We investigated whether PS was effective in decreasing the frequency of ventilatory arrhythmias (VA) produced during moderate sedation with midazolam and remifentanil in both room air (RA) and 2 l/m nasal O2. Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Capsaicin : 0.075% topical cream application
330695|NCT01170962|B4|Baseline|Total|Total of all reporting groups
330696|NCT01170962|B3|Baseline|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330697|NCT01170962|B2|Baseline|Daclastavir (60mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
351112|NCT01119755|O1|Outcome|Group 1|
330698|NCT01170962|B1|Baseline|Daclastavir (20mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330699|NCT01170962|P3|Participant Flow|Placebo: Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330700|NCT01170962|P2|Participant Flow|Daclatasvir (60 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330701|NCT01170962|P1|Participant Flow|Daclatasvir (20 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330702|NCT01170962|O3|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330703|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330704|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330705|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330755|NCT01170884|B1|Baseline|Combigan® + Lumigan®|COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
331141|NCT01169675|O1|Outcome|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
330706|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330707|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330708|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330709|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy.
330710|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330711|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330712|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330713|NCT01170962|O5|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330756|NCT01170884|P2|Participant Flow|Lumigan®|LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
330757|NCT01170884|P1|Participant Flow|Combigan® + Lumigan®|COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
330758|NCT01170884|O2|Outcome|Lumigan®|LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
330714|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330715|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330716|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330717|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330718|NCT01170962|O5|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330719|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330720|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330721|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330928|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
330722|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330723|NCT01170962|O5|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily along with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily up to 24 weeks. Participants continued to receive pegIFNα-2a and ribavirin, up to 48 weeks followed by a post treatment follow-up period of 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330724|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330725|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330726|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330727|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330728|NCT01170962|O3|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330729|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330759|NCT01170884|O1|Outcome|Combigan® + Lumigan®|COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
330760|NCT01170884|E2|Reported Event|Lumigan®|LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
330730|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330731|NCT01170962|O5|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330732|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330733|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330734|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330735|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330736|NCT01170962|O5|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330737|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330761|NCT01170884|E1|Reported Event|Combigan® + Lumigan®|COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
330762|NCT01170754|B3|Baseline|Total|Total of all reporting groups
330763|NCT01170754|B2|Baseline|Golytely 4 Liters|"Golytely 4 Liters~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
330738|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330739|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330740|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330741|NCT01170962|E3|Reported Event|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330742|NCT01170962|E2|Reported Event|Daclatasvir (60 mg): Prior Null and Partial Responders|Participant (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330743|NCT01170962|E1|Reported Event|Daclatasvir (20 mg): Prior Null and Partial Responders|Participant (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
330744|NCT01170949|B3|Baseline|Total|Total of all reporting groups
330745|NCT01170949|B2|Baseline|Placebo|
330746|NCT01170949|B1|Baseline|Miltefosine|
330747|NCT01170949|P2|Participant Flow|Placebo|Week 1 – 50 mg miltefosine or placebo Week 2 – 100 mg miltefosine or placebo (1 capsule in the morning and one in the evening),if evidence of intolerability dose had to be reduced to 50 mg, those patients received 50 mg until the end of the treatment period Week 3 – 150 mg miltefosine or placebo (3 capsules, one in the morning, one at lunch and one in the evening) if evidence of intolerability dose had to be reduced to 100 mg, those patients received 100 mg until the end of the treatment period
330748|NCT01170949|P1|Participant Flow|Miltefosine|Week 1 – 50 mg miltefosine or placebo Week 2 – 100 mg miltefosine or placebo (1 capsule in the morning and one in the evening),if evidence of intolerability dose had to be reduced to 50 mg, those patients received 50 mg until the end of the treatment period Week 3 – 150 mg miltefosine or placebo (3 capsules, one in the morning, one at lunch and one in the evening) if evidence of intolerability dose had to be reduced to 100 mg, those patients received 100 mg until the end of the treatment period
330749|NCT01170949|O2|Outcome|Placebo|Placebo: Placebo
330750|NCT01170949|O1|Outcome|Miltefosine|Miltefosine: 50 or 100 or 150mg per day
330751|NCT01170949|E2|Reported Event|Placebo|
330752|NCT01170949|E1|Reported Event|Miltefosine|
330753|NCT01170884|B3|Baseline|Total|Total of all reporting groups
330754|NCT01170884|B2|Baseline|Lumigan®|LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
330929|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
330764|NCT01170754|B1|Baseline|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
330765|NCT01170754|P2|Participant Flow|Golytely 4 Liters|"Golytely 4 Liters~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
330766|NCT01170754|P1|Participant Flow|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
330767|NCT01170754|O2|Outcome|Golytely 4 Liters|"Golytely 4 Liters~Golytely 4 liters: Golytely 4 liters"
330768|NCT01170754|O1|Outcome|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~PEG-3350 and Gatorade: 255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation."
330769|NCT01170754|O2|Outcome|Golytely 4 Liters|"Golytely 4 Liters~Golytely 4 liters: Golytely 4 liters"
330770|NCT01170754|O1|Outcome|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~PEG-3350 and Gatorade: 255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation."
330771|NCT01170754|O2|Outcome|Golytely 4 Liters|"Golytely 4 Liters~Golytely 4 liters: Golytely 4 liters"
330772|NCT01170754|O1|Outcome|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~PEG-3350 and Gatorade: 255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation."
330773|NCT01170754|O2|Outcome|Golytely 4 Liters|"Golytely 4 Liters~Golytely 4 liters: Golytely 4 liters"
330774|NCT01170754|O1|Outcome|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~PEG-3350 and Gatorade: 255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation."
330775|NCT01170754|O2|Outcome|Golytely 4 Liters|"Golytely 4 Liters~Golytely 4 liters: Golytely 4 liters"
330776|NCT01170754|O1|Outcome|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~PEG-3350 and Gatorade: 255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation."
330777|NCT01170754|O2|Outcome|Golytely 4 Liters|"Golytely 4 Liters~Golytely 4 liters: Golytely 4 liters"
330778|NCT01170754|O1|Outcome|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~PEG-3350 and Gatorade: 255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation."
330779|NCT01170754|O2|Outcome|Golytely 4 Liters|"Golytely 4 Liters~Golytely 4 liters: Golytely 4 liters"
330780|NCT01170754|O1|Outcome|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~PEG-3350 and Gatorade: 255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation."
330781|NCT01170754|O2|Outcome|Golytely 4 Liters|"Golytely 4 Liters~Golytely 4 liters: Golytely 4 liters"
330782|NCT01170754|O1|Outcome|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~PEG-3350 and Gatorade: 255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation."
330783|NCT01170754|O2|Outcome|Golytely 4 Liters|"Golytely 4 Liters~Golytely 4 liters: Golytely 4 liters"
330784|NCT01170754|O1|Outcome|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~PEG-3350 and Gatorade: 255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation."
330785|NCT01170754|O2|Outcome|Golytely 4 Liters|"Golytely 4 Liters~Golytely 4 liters: Golytely 4 liters"
330786|NCT01170754|O1|Outcome|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~PEG-3350 and Gatorade: 255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation."
330787|NCT01170754|O2|Outcome|Golytely 4 Liters|"Golytely 4 Liters~Golytely 4 liters: Golytely 4 liters"
330788|NCT01170754|O1|Outcome|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~PEG-3350 and Gatorade: 255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation."
330789|NCT01170754|O2|Outcome|Golytely 4 Liters|"Golytely 4 Liters~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
330790|NCT01170754|O1|Outcome|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
330791|NCT01170754|E2|Reported Event|Golytely 4 Liters|"Golytely 4 Liters~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
330792|NCT01170754|E1|Reported Event|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
330793|NCT01170663|B3|Baseline|Total|Total of all reporting groups
330794|NCT01170663|B2|Baseline|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
330795|NCT01170663|B1|Baseline|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
330796|NCT01170663|P2|Participant Flow|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
330797|NCT01170663|P1|Participant Flow|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 milligrams/kilogram (mg/kg) of ramucirumab (IMC-1121B) was administered by intravenous (IV) infusion on Days 1 and 15 in combination with 80 milligrams/square meter (mg/m²) paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
330798|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
330799|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
330800|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
330801|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
330802|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
330803|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
330804|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
330805|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
330806|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
330807|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
330808|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
330809|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
330810|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
330811|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
330812|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
330813|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
330814|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
330815|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
330816|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
330817|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
330818|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
330819|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
330820|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
330821|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
330822|NCT01170663|E2|Reported Event|Placebo and Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² administered on Days 1, 8, and 15 of a 28-day cycle.
330823|NCT01170663|E1|Reported Event|Ramucirumab and Paclitaxel|8 mg/kg ramucirumab (IMC1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
330824|NCT01170598|B1|Baseline|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
330825|NCT01170598|P1|Participant Flow|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
330826|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
330827|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
330828|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
331142|NCT01169675|O5|Outcome|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
330829|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
330830|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
330831|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
330832|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
330833|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
330834|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
330835|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
330836|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
330837|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
330838|NCT01170598|E1|Reported Event|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
330839|NCT01170546|B5|Baseline|Total|Total of all reporting groups
330840|NCT01170546|B4|Baseline|Control|Control group
330841|NCT01170546|B3|Baseline|KLC ( Kneeling Leg Curl)|plate-loaded kneeling leg curl
330842|NCT01170546|B2|Baseline|SP (Squat Press)|plate-loaded squat press
330843|NCT01170546|B1|Baseline|KLCIR|plate-loaded kneeling leg curl with internal rotation
330844|NCT01170546|P4|Participant Flow|Control|Control group
330845|NCT01170546|P3|Participant Flow|KLC ( Kneeling Leg Curl)|plate-loaded kneeling leg curl
330846|NCT01170546|P2|Participant Flow|SP (Squat Press)|plate-loaded squat press
330847|NCT01170546|P1|Participant Flow|KLCIR|plate-loaded kneeling leg curl with internal rotation
330848|NCT01170546|O4|Outcome|Control|Control group
330849|NCT01170546|O3|Outcome|KLC ( Kneeling Leg Curl)|plate-loaded kneeling leg curl
330850|NCT01170546|O2|Outcome|SP (Squat Press)|plate-loaded squat press
330851|NCT01170546|O1|Outcome|KLCIR|plate-loaded kneeling leg curl with internal rotation
330852|NCT01170546|E4|Reported Event|Control|Control group
330853|NCT01170546|E3|Reported Event|KLC ( Kneeling Leg Curl)|plate-loaded kneeling leg curl
330854|NCT01170546|E2|Reported Event|SP (Squat Press)|plate-loaded squat press
330855|NCT01170546|E1|Reported Event|KLCIR|plate-loaded kneeling leg curl with internal rotation
330856|NCT01170533|B1|Baseline|All Study Participants|"This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI therapy (CLOP regimen).~The PPI could be omeprazole (first phase) or pantoprazole (second phase)."
330878|NCT01170390|O1|Outcome|Aviane and Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
330879|NCT01170390|O2|Outcome|Aviane and Portia|A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
331143|NCT01169675|O4|Outcome|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
330857|NCT01170533|P2|Participant Flow|Pantoprazole|This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI (pantoprazole) concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI (pantoprazole) therapy (CLOP regimen).
330858|NCT01170533|P1|Participant Flow|Omeprazole|This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI (omeprazole) concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI (omeprazole)in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI therapy (CLOP regimen).
330859|NCT01170533|O6|Outcome|Clopidogrel Only (Pantoprazole Phase)|Participants took clopidogrel only
330860|NCT01170533|O5|Outcome|Clopidogrel Only (Omeprazole Phase)|Participants took clopidogrel only
330861|NCT01170533|O4|Outcome|Pantoprazole Staggered|Participants took pantoprazole with clopidogrel staggered
330862|NCT01170533|O3|Outcome|Pantoprazole Concomitant|Participants took pantoprazole with clopidogrel concomitantly
330863|NCT01170533|O2|Outcome|Omeprazole Staggered|Participants took omeprazole with clopidogrel staggered
330864|NCT01170533|O1|Outcome|Omeprazole Concomitant|Participants took omeprazole with clopidogrel concomitantly
330865|NCT01170533|E2|Reported Event|Pantoprazole|This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI (pantoprazole) concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI (pantoprazole) therapy (CLOP regimen).
330866|NCT01170533|E1|Reported Event|Omeprazole|This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI (omeprazole) concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI (omeprazole)in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI therapy (CLOP regimen).
330867|NCT01170390|B3|Baseline|Total|Total of all reporting groups
330868|NCT01170390|B2|Baseline|Aviane and Portia|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
330869|NCT01170390|B1|Baseline|Aviane and Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
330870|NCT01170390|P3|Participant Flow|Study Arm #2 (Aviane and Portia)|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
330871|NCT01170390|P2|Participant Flow|Study Arm #1 (Aviane and Aviane)|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
330872|NCT01170390|P1|Participant Flow|All Participants|All participants were given a low dose oral contraceptive (Aviane) cyclically for 2 months
330873|NCT01170390|O2|Outcome|Aviane and Portia|A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
330874|NCT01170390|O1|Outcome|Aviane & Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
330875|NCT01170390|O2|Outcome|Aviane and Portia|A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
330876|NCT01170390|O1|Outcome|Aviane & Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
330877|NCT01170390|O2|Outcome|Aviane and Portia|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
332224|NCT01165983|O1|Outcome|Subjects at Risk of DMII|
330880|NCT01170390|O1|Outcome|Aviane & Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
330881|NCT01170390|O2|Outcome|Aviane and Portia|A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
330882|NCT01170390|O1|Outcome|Aviane & Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
330883|NCT01170390|E2|Reported Event|Aviane and Portia|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
330884|NCT01170390|E1|Reported Event|Aviane and Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
330885|NCT01170364|B3|Baseline|Total|Total of all reporting groups
330886|NCT01170364|B2|Baseline|Placebo First, Then Sibutramine|Participants in this group were randomized to begin with 14 days of placebo, followed by 7 days of 15mg of sibutramine.
330887|NCT01170364|B1|Baseline|Sibutramine First, Then Placebo|Participants in this group were randomized to begin with 7 days of 15mg of sibutramine, followed by 14 days of placebo.
330888|NCT01170364|P2|Participant Flow|Placebo First, Then Sibutramine|This is a cross over design study. Participants in this arm begin with two weeks of placebo, followed by one week of 15mg of sibutramine
330889|NCT01170364|P1|Participant Flow|Sibutramine First, Then Placebo|This is a cross over design study. Participants in this arm begin with one week of 15mg sibutramine, followed by two weeks of placebo.
330890|NCT01170364|O2|Outcome|Placebo|In this arm, participants received placebo (for 15mg sibumtramine) for 7 days.
330891|NCT01170364|O1|Outcome|Sibutramine|In this arm, participants received sibutramine 15mg for 7 days
330892|NCT01170364|E2|Reported Event|Placebo|Participants who received a placebo capsule (matching sibutramine 15mg) every morning for 7 days.
330893|NCT01170364|E1|Reported Event|Sibutramine|Participants who received sibutramine 15mg capsule every morning for 7 days.
330894|NCT01170273|B3|Baseline|Total|Total of all reporting groups
330895|NCT01170273|B2|Baseline|Cholecalciferol 4000 IU|"cholecalciferol 4000 IU daily~vitamin D: cholecalciferol~participants received one daily tablet containing cholecalciferol 4000 IU for 9 months"
330896|NCT01170273|B1|Baseline|Placebo Arm|"placebo capsule~placebo: placebo tablet~participants received one daily tablet containing placebo for 9 months"
330897|NCT01170273|P2|Participant Flow|Cholecalciferol 4000 IU|"cholecalciferol 4000 IU daily~vitamin D: cholecalciferol~participants received one daily tablet containing cholecalciferol 4000 IU for 9 months"
330898|NCT01170273|P1|Participant Flow|Placebo Arm|"placebo capsule~placebo: placebo tablet~participants received one daily tablet containing placebo for 9 months"
330899|NCT01170273|O2|Outcome|Cholecalciferol 4000 IU|"cholecalciferol 4000 IU daily~vitamin D: cholecalciferol~participants received one daily tablet containing cholecalciferol 4000 IU for 9 months"
330900|NCT01170273|O1|Outcome|Placebo Arm|"placebo capsule~placebo: placebo tablet~participants received one daily tablet containing placebo for 9 months"
330901|NCT01170273|E2|Reported Event|Cholecalciferol 4000 IU|"cholecalciferol 4000 IU daily~vitamin D: cholecalciferol~participants received one daily tablet containing cholecalciferol 4000 IU for 9 months"
330902|NCT01170273|E1|Reported Event|Placebo Arm|"placebo capsule~placebo: placebo tablet~participants received one daily tablet containing placebo for 9 months"
330903|NCT01170247|B3|Baseline|Total|Total of all reporting groups
330904|NCT01170247|B2|Baseline|Intramuscular Ketamine|
330905|NCT01170247|B1|Baseline|Intranasal Ketamine|
330906|NCT01170247|P2|Participant Flow|Intramuscular Ketamine|
330907|NCT01170247|P1|Participant Flow|Intranasal Ketamine|Enrolled 2 patients over 6 month period
330908|NCT01170247|O2|Outcome|Intramuscular Ketamine|Ketamine: Intramuscular Ketamine
330909|NCT01170247|O1|Outcome|Intranasal Ketamine|Ketamine: Intranasal Ketamine (100 mg/mL)
330910|NCT01170247|E2|Reported Event|Intramuscular Ketamine|None report
330911|NCT01170247|E1|Reported Event|Intranasal Ketamine|None Reported
330912|NCT01170221|B3|Baseline|Total|Total of all reporting groups
330913|NCT01170221|B2|Baseline|Linezolid|Oral linezolid 600 mg twice daily for 10 days
330914|NCT01170221|B1|Baseline|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
330915|NCT01170221|P2|Participant Flow|Linezolid|Oral linezolid 600 mg twice daily for 10 days
330916|NCT01170221|P1|Participant Flow|Tedizolid Phosphate|Oral Tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
330917|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
330918|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
330919|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
330920|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
330921|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
330922|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
330923|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
330924|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
330925|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
338268|NCT01150409|B3|Baseline|Total|Total of all reporting groups
330930|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
330931|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
330932|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
330933|NCT01170221|E2|Reported Event|Linezolid|Oral linezolid 600 mg twice daily for 10 days
330934|NCT01170221|E1|Reported Event|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
330935|NCT01170208|B4|Baseline|Total|Total of all reporting groups
330936|NCT01170208|B3|Baseline|Group III|Type 2 diabetes treated with biphasic insulin.
330937|NCT01170208|B2|Baseline|Group II|Type 2 diabetes treated with basalbolus therapy
330938|NCT01170208|B1|Baseline|Group I|Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting
330939|NCT01170208|P3|Participant Flow|Group III|Type 2 diabetes treated with biphasic insulin.
330940|NCT01170208|P2|Participant Flow|Group II|Type 2 diabetes treated with basalbolus therapy
330941|NCT01170208|P1|Participant Flow|Group I|Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting
330942|NCT01170208|O3|Outcome|Group III|Type 2 diabetes treated with biphasic insulin
330943|NCT01170208|O2|Outcome|Group II|Type 2 diabetes treated with basal bolus therapy
330944|NCT01170208|O1|Outcome|Group I|Type 1 diabetes treated with basal-bolus insulin the
330945|NCT01170208|E3|Reported Event|Group III|Type 2 diabetes treated with biphasic insulin.
330946|NCT01170208|E2|Reported Event|Group II|Type 2 diabetes treated with basalbolus therapy
330947|NCT01170208|E1|Reported Event|Group I|Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting
330948|NCT01170117|B3|Baseline|Total|Total of all reporting groups
330949|NCT01170117|B2|Baseline|Olanzapine|"Group receiving olanzapine~Olanzapine: Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients."
330950|NCT01170117|B1|Baseline|Placebo|"Control group receiving placebo~Placebo: Control Group will receive placebo pill"
330951|NCT01170117|P2|Participant Flow|Olanzapine|"Group receiving olanzapine~Olanzapine: Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients."
330952|NCT01170117|P1|Participant Flow|Placebo|"Control group receiving placebo~Placebo: Control Group will receive placebo pill."
330953|NCT01170117|O2|Outcome|Olanzapine|"Group receiving olanzapine~Olanzapine: Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients."
330954|NCT01170117|O1|Outcome|Placebo|"Control group receiving placebo~Placebo: Control Group will receive placebo pill."
330955|NCT01170117|O2|Outcome|Olanzapine|"Group receiving olanzapine~Olanzapine: Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients."
330956|NCT01170117|O1|Outcome|Placebo|"Control group receiving placebo~Placebo: Control Group will receive placebo pill."
330957|NCT01170117|E2|Reported Event|Olanzapine|"Group receiving olanzapine~Olanzapine: Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients."
330958|NCT01170117|E1|Reported Event|Placebo|"Control group receiving placebo~Placebo: Control Group will receive placebo pill."
330959|NCT01170091|B1|Baseline|Patients With Restless Legs Syndrome (RLS)|Patients with RLS who had initiated with Mirapex
330960|NCT01170091|P1|Participant Flow|Mirapex|Patients with RLS who had initiated with Mirapex
330961|NCT01170091|O1|Outcome|Mirapex|Patients with RLS who had initiated with Mirapex
330962|NCT01170091|O1|Outcome|Mirapex|Patients with RLS who had initiated with Mirapex
330963|NCT01170091|O1|Outcome|Mirapex|Patients with RLS who had initiated with Mirapex
330964|NCT01170091|O1|Outcome|Mirapex|Patients with RLS who had initiated with Mirapex
330965|NCT01170091|E1|Reported Event|Patients With Restless Legs Syndrome (RLS)|Patients with RLS who had initiated with Mirapex
330966|NCT01170039|B3|Baseline|Total|Total of all reporting groups
330967|NCT01170039|B2|Baseline|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
330968|NCT01170039|B1|Baseline|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
330969|NCT01170039|P2|Participant Flow|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
330970|NCT01170039|P1|Participant Flow|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
330971|NCT01170039|O2|Outcome|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
330972|NCT01170039|O1|Outcome|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
330973|NCT01170039|O2|Outcome|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
330974|NCT01170039|O1|Outcome|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
330975|NCT01170039|O2|Outcome|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
330976|NCT01170039|O1|Outcome|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
330977|NCT01170039|O2|Outcome|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
330978|NCT01170039|O1|Outcome|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
331144|NCT01169675|O3|Outcome|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
330979|NCT01170039|E2|Reported Event|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
330980|NCT01170039|E1|Reported Event|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
330981|NCT01169987|B1|Baseline|Participants Treated With Adalimumab|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.
330982|NCT01169987|P1|Participant Flow|Participants Treated With Adalimumab|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.
330983|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
330984|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
330985|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
330986|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
330987|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
330988|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
330989|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
330990|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
330991|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
330992|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
330993|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
330994|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
330995|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
330996|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
330997|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
330998|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
330999|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
338674|NCT01149733|E2|Reported Event|Flomax®|0.4 mg Capsule
331000|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
331001|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
331002|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
331003|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
331004|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
331005|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
331006|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
331007|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
331008|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
331009|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
331010|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
331011|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
331012|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
331013|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
331014|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
331015|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
331016|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
331017|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
331018|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
331019|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
351113|NCT01119755|O1|Outcome|Group 1|
331020|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
331021|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
331022|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
331023|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
331024|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
331025|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
331026|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
331027|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
331028|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
331029|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
331030|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
331031|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
331032|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
331033|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
331034|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
331035|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
331036|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
331037|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
331038|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
331039|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
331145|NCT01169675|O2|Outcome|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
331040|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
331041|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
331042|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
331043|NCT01169987|O1|Outcome|Participants Treated With Adalimumab|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.
331044|NCT01169987|E1|Reported Event|Participants Treated With Adalimumab|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.
331045|NCT01169779|B3|Baseline|Total|Total of all reporting groups
331046|NCT01169779|B2|Baseline|Lixisenatide|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.
331047|NCT01169779|B1|Baseline|Placebo|1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.
331048|NCT01169779|P2|Participant Flow|Lixisenatide|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.
331049|NCT01169779|P1|Participant Flow|Placebo|1-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.
331050|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
331051|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
331052|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
331053|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
331054|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
331055|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
331056|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
331057|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
331058|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
331059|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
331060|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
331061|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
331062|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
331063|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
331064|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
331065|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
331066|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
331067|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
331068|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
331069|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
331070|NCT01169779|E2|Reported Event|Lixisenatide|1-step initiation regimen of lixisenatide.
331071|NCT01169779|E1|Reported Event|Placebo|1-step initiation regimen of volume matching placebo.
331072|NCT01169753|B3|Baseline|Total|Total of all reporting groups
331073|NCT01169753|B2|Baseline|Armodafinil|Armodafinil Three 50 mg tablets orally every morning for 2 weeks.
331074|NCT01169753|B1|Baseline|Placebo|Oral placebo every morning for 2 weeks.
331075|NCT01169753|P2|Participant Flow|Armodafinil|Armodafinil Three 50 mg tablets orally every morning for 2 weeks.
331076|NCT01169753|P1|Participant Flow|Placebo|Oral placebo every morning for 2 weeks.
331077|NCT01169753|O2|Outcome|Armodafinil|Armodafinil Three 50 mg tablets orally every morning for 2 weeks.
331078|NCT01169753|O1|Outcome|Placebo|Oral placebo every morning for 2 weeks.
331079|NCT01169753|E2|Reported Event|Armodafinil|Armodafinil Three 50 mg tablets orally every morning for 2 weeks.
331080|NCT01169753|E1|Reported Event|Placebo|Oral placebo every morning for 2 weeks.
331081|NCT01169701|B3|Baseline|Total|Total of all reporting groups
331082|NCT01169701|B2|Baseline|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
331083|NCT01169701|B1|Baseline|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
331103|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
331146|NCT01169675|O1|Outcome|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
351114|NCT01119755|O1|Outcome|Group 1|
331084|NCT01169701|P2|Participant Flow|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
331085|NCT01169701|P1|Participant Flow|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
331086|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
331087|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
331088|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
331089|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
331090|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
331091|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
331092|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
331093|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
331094|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
331095|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
331096|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
331097|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
331098|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
331099|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
331100|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
331101|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
331102|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
331140|NCT01169675|O2|Outcome|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
331104|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
331105|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
331106|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
331107|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
331108|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
331109|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
331110|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
331111|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
331112|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
331113|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
331114|NCT01169701|E2|Reported Event|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
331115|NCT01169701|E1|Reported Event|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
331116|NCT01169675|B6|Baseline|Total|Total of all reporting groups
331117|NCT01169675|B5|Baseline|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
331118|NCT01169675|B4|Baseline|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
331119|NCT01169675|B3|Baseline|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
331120|NCT01169675|B2|Baseline|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
331121|NCT01169675|B1|Baseline|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
331122|NCT01169675|P5|Participant Flow|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
331123|NCT01169675|P4|Participant Flow|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
331124|NCT01169675|P3|Participant Flow|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
331125|NCT01169675|P2|Participant Flow|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
331126|NCT01169675|P1|Participant Flow|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
331127|NCT01169675|O5|Outcome|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
331128|NCT01169675|O4|Outcome|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
331129|NCT01169675|O3|Outcome|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
331130|NCT01169675|O2|Outcome|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
331131|NCT01169675|O1|Outcome|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
331132|NCT01169675|O5|Outcome|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
331133|NCT01169675|O4|Outcome|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
331134|NCT01169675|O3|Outcome|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
331135|NCT01169675|O2|Outcome|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
331136|NCT01169675|O1|Outcome|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
331137|NCT01169675|O5|Outcome|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
331138|NCT01169675|O4|Outcome|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
331139|NCT01169675|O3|Outcome|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
331147|NCT01169675|O5|Outcome|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
331148|NCT01169675|O4|Outcome|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
331149|NCT01169675|O3|Outcome|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
331150|NCT01169675|O2|Outcome|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
331151|NCT01169675|O1|Outcome|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
331152|NCT01169675|O5|Outcome|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
331153|NCT01169675|O4|Outcome|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
331154|NCT01169675|O3|Outcome|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
331155|NCT01169675|O2|Outcome|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
331156|NCT01169675|O1|Outcome|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
331157|NCT01169675|E5|Reported Event|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
331158|NCT01169675|E4|Reported Event|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
331159|NCT01169675|E3|Reported Event|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
331160|NCT01169675|E2|Reported Event|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
331161|NCT01169675|E1|Reported Event|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
331162|NCT01169649|B1|Baseline|MK-2206 in Patients With Metastatic Neuroendocrine Tumors|This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
331163|NCT01169649|P1|Participant Flow|MK-2206 in Patients With Metastatic Neuroendocrine Tumors|This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
331164|NCT01169649|O1|Outcome|MK-2206 in Patients With Metastatic Neuroendocrine Tumors|This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
331165|NCT01169649|E1|Reported Event|MK-2206 in Patients With Metastatic Neuroendocrine Tumors|This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
331166|NCT01169610|B1|Baseline|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
331167|NCT01169610|P1|Participant Flow|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
331168|NCT01169610|O1|Outcome|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
331169|NCT01169610|O1|Outcome|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
331170|NCT01169610|O1|Outcome|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
331171|NCT01169610|O1|Outcome|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
331172|NCT01169610|O1|Outcome|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
331173|NCT01169610|E1|Reported Event|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
331174|NCT01169558|B1|Baseline|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
331175|NCT01169558|P1|Participant Flow|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
331176|NCT01169558|O1|Outcome|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
331177|NCT01169558|O1|Outcome|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
331178|NCT01169558|O1|Outcome|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
331241|NCT01169467|O1|Outcome|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
338675|NCT01149733|E1|Reported Event|Tamsulosin|0.4 mg Capsule
331179|NCT01169558|O1|Outcome|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
331180|NCT01169558|E1|Reported Event|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
331181|NCT01169519|B1|Baseline|Sildenafil|"Pharmacokinetic and hemodynamic evaluation following sildenafil administration~Sildenafil by injection : Sildenafil 0.45mg/kg by injection over 20min~Sildenafil by injection : Sildenafil 0.25mg/kg injection over 20min~Sildenafil by injection : Sildenafil 0.35mg/kg by injection over 20min~Sildenafil by injection : Sildenafil 0.125mg/kg injection over 20min"
331182|NCT01169519|P1|Participant Flow|Baseline/Sildenafil|Assessment of baseline hemodynamics followed by sildenafil infusion with repeat assessment of hemodynamics
331183|NCT01169519|O2|Outcome|Sildenafil|"Pharmacokinetic and hemodynamic evaluation following sildenafil administration~Sildenafil by injection : Sildenafil 0.45mg/kg by injection over 20min~Sildenafil by injection : Sildenafil 0.25mg/kg injection over 20min~Sildenafil by injection : Sildenafil 0.35mg/kg by injection over 20min~Sildenafil by injection : Sildenafil 0.125mg/kg injection over 20min"
331184|NCT01169519|O1|Outcome|Baseline|Assessment of baseline hemodynamics
331185|NCT01169519|O4|Outcome|Peak Sildenafil Level (ng/mL) for Dose = 0.25mg/kg|Maximum sildenafil plasma concentration measured 5 minutes after completion of sildenafil infusionplasma concentration
331186|NCT01169519|O3|Outcome|Peak Sildenafil Level (ng/mL) for Dose = 0.45mg/kg|Maximum sildenafil plasma concentration measured 5 minutes after completion of sildenafil infusion
331187|NCT01169519|O2|Outcome|Peak Sildenafil Level (ng/mL) for Dose = 0.35mg/kg|Maximum sildenafil plasma concentration measured 5 minutes after completion of sildenafil infusion
331188|NCT01169519|O1|Outcome|Peak Sildenafil Level (ng/mL) for Dose = 0.125mg/kg|Maximum sildenafil plasma concentration measured 5 minutes after completion of sildenafil infusion
331189|NCT01169519|E4|Reported Event|Dose = 0.45mg/kg|Subjects receiving a sildenafil dose of 0.45mg/kg IV over 20 min
331190|NCT01169519|E3|Reported Event|Dose = 0.35mg/kg|Subjects receiving a sildenafil dose of 0.35mg/kg IV over 20 min
331191|NCT01169519|E2|Reported Event|Dose = 0.25mg/kg|Subjects receiving a sildenafil dose of 0.25mg/kg IV over 20 min
331192|NCT01169519|E1|Reported Event|Dose = 0.125mg/kg|Subjects receiving a sildenafil dose of 0.125mg/kg IV over 20 min
331193|NCT01169493|B7|Baseline|Total|Total of all reporting groups
331194|NCT01169493|B6|Baseline|RV DDD-40 to Bi-V DDD-40 to VVI-40|"Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
331195|NCT01169493|B5|Baseline|RV DDD-40 to VVI-40 to Bi-V DDD-40|"Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
331196|NCT01169493|B4|Baseline|Bi-V DDD-40 to RV DDD-40 to VVI-40|"Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
331197|NCT01169493|B3|Baseline|Bi-V DDD-40 to VVI-40 to RV DDD-40|"Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to RV DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
331198|NCT01169493|B2|Baseline|VVI-40 to Bi-V DDD-40 to RV DDD-40|"Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to RV DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
331199|NCT01169493|B1|Baseline|VVI-40 to RV DDD-40 to Bi-V DDD-40|"Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
331200|NCT01169493|P6|Participant Flow|RV DDD-40 to Bi-V DDD-40 to VVI-40|"Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
331201|NCT01169493|P5|Participant Flow|RV DDD-40 to VVI-40 to Bi-V DDD-40|"Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
331242|NCT01169467|O2|Outcome|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
331365|NCT01168986|O3|Outcome|No Intervention|Participants receive/perform no intervention
331202|NCT01169493|P4|Participant Flow|Bi-V DDD-40 to RV DDD-40 to VVI-40|"Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
331203|NCT01169493|P3|Participant Flow|Bi-V DDD-40 to VVI-40 to RV DDD-40|"Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2.~Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3.~Period 3: Participants assigned to RV DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
331204|NCT01169493|P2|Participant Flow|VVI-40 to Bi-V DDD-40 to RV DDD-40|"Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2.~Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3.~Period 3: Participants assigned to RV DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
331205|NCT01169493|P1|Participant Flow|VVI-40 to RV DDD-40 to Bi-V DDD-40|"Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2.~Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3.~Period 3: Participants assigned to Bi-V DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
331206|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
331207|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
331208|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
331209|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
331210|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
331211|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
331212|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
331213|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
331214|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
331215|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
331216|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
331217|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
331218|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
331219|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
331220|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
331221|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
331222|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
331223|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
331224|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
331225|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
331226|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
331227|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
331228|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
331229|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
331230|NCT01169493|E3|Reported Event|Bi-V DDD-40|Bi-V DDD-40: ICD programmed to Bi-V pacing at a lower rate of 40
331231|NCT01169493|E2|Reported Event|RV DDD-40|RV DDD-40: ICD programmed to DDD-40, RV only pacing with an AV interval producing QRS fusion on surface EKG.
331232|NCT01169493|E1|Reported Event|VVI-40|VVI-40: Pacing mode set to VVI-40, RV only pacing
331233|NCT01169467|B3|Baseline|Total|Total of all reporting groups
331234|NCT01169467|B2|Baseline|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
331235|NCT01169467|B1|Baseline|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
331236|NCT01169467|P2|Participant Flow|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
331237|NCT01169467|P1|Participant Flow|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
331238|NCT01169467|O2|Outcome|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
331239|NCT01169467|O1|Outcome|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
331240|NCT01169467|O2|Outcome|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
331243|NCT01169467|O1|Outcome|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
331244|NCT01169467|O2|Outcome|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
331245|NCT01169467|O1|Outcome|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
331246|NCT01169467|O2|Outcome|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
331247|NCT01169467|O1|Outcome|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
331248|NCT01169467|E2|Reported Event|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
331249|NCT01169467|E1|Reported Event|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
331250|NCT01169350|B1|Baseline|Diagnostic (18F FDG and 18F FMISO PET/CT)|"Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.~fludeoxyglucose F 18: Undergo 18F FDG and 18F FMISO PET/CT scans~18F-fluoromisonidazole: Undergo 18F FDG and 18F FMISO PET/CT scans~positron emission tomography: Undergo 18F FDG and 18F FMISO PET/CT scans~computed tomography: Undergo 18F FDG and 18F FMISO PET/CT scans~laboratory biomarker analysis: Correlative studies"
331251|NCT01169350|P1|Participant Flow|Diagnostic (18F FDG and 18F FMISO PET/CT)|"Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.~fludeoxyglucose F 18: Undergo 18F FDG and 18F FMISO PET/CT scans~18F-fluoromisonidazole: Undergo 18F FDG and 18F FMISO PET/CT scans~positron emission tomography: Undergo 18F FDG and 18F FMISO PET/CT scans~computed tomography: Undergo 18F FDG and 18F FMISO PET/CT scans~laboratory biomarker analysis: Correlative studies"
331252|NCT01169350|O1|Outcome|Diagnostic (18F FDG and 18F FMISO PET/CT)|"Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.~fludeoxyglucose F 18: Undergo 18F FDG and 18F FMISO PET/CT scans~18F-fluoromisonidazole: Undergo 18F FDG and 18F FMISO PET/CT scans~positron emission tomography: Undergo 18F FDG and 18F FMISO PET/CT scans~computed tomography: Undergo 18F FDG and 18F FMISO PET/CT scans~laboratory biomarker analysis: Correlative studies"
331253|NCT01169350|O1|Outcome|Diagnostic (18F FDG and 18F FMISO PET/CT)|"Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.~fludeoxyglucose F 18: Undergo 18F FDG and 18F FMISO PET/CT scans~18F-fluoromisonidazole: Undergo 18F FDG and 18F FMISO PET/CT scans~positron emission tomography: Undergo 18F FDG and 18F FMISO PET/CT scans~computed tomography: Undergo 18F FDG and 18F FMISO PET/CT scans~laboratory biomarker analysis: Correlative studies"
331254|NCT01169350|O1|Outcome|Diagnostic (18F FDG and 18F FMISO PET/CT)|"Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.~fludeoxyglucose F 18: Undergo 18F FDG and 18F FMISO PET/CT scans~18F-fluoromisonidazole: Undergo 18F FDG and 18F FMISO PET/CT scans~positron emission tomography: Undergo 18F FDG and 18F FMISO PET/CT scans~computed tomography: Undergo 18F FDG and 18F FMISO PET/CT scans~laboratory biomarker analysis: Correlative studies"
331255|NCT01169350|O1|Outcome|Diagnostic (18F FDG and 18F FMISO PET/CT)|"Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.~fludeoxyglucose F 18: Undergo 18F FDG and 18F FMISO PET/CT scans~18F-fluoromisonidazole: Undergo 18F FDG and 18F FMISO PET/CT scans~positron emission tomography: Undergo 18F FDG and 18F FMISO PET/CT scans~computed tomography: Undergo 18F FDG and 18F FMISO PET/CT scans~laboratory biomarker analysis: Correlative studies"
331256|NCT01169350|E1|Reported Event|Diagnostic (18F FDG and 18F FMISO PET/CT)|"Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.~fludeoxyglucose F 18: Undergo 18F FDG and 18F FMISO PET/CT scans~18F-fluoromisonidazole: Undergo 18F FDG and 18F FMISO PET/CT scans~positron emission tomography: Undergo 18F FDG and 18F FMISO PET/CT scans~computed tomography: Undergo 18F FDG and 18F FMISO PET/CT scans~laboratory biomarker analysis: Correlative studies"
331257|NCT01169311|B1|Baseline|Covidien EEA Hemorrhoid and Prolapse Stapler|Subjects undergoing hemorrhoidopexy with HEEA stapler
331258|NCT01169311|P1|Participant Flow|Covidien EEA Hemorrhoid and Prolapse Stapler|Subjects meeting inclusion/exclusion criteria will undergo hemorrhoidopexy with the Covidien EEA hemorrhoid and prolapse stapler set.
331259|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
331260|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
331261|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
331262|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|Subjects meeting inclusion/exclusion criteria will undergo hemorrhoidopexy with the Covidien EEA hemorrhoid and prolapse stapler set.
331263|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
331264|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
331265|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
331266|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
331267|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
331268|NCT01169311|E1|Reported Event|Covidien EEA Hemorrhoid and Prolapse Stapler|Subjects undergoing hemorrhoidopexy with HEEA stapler
331269|NCT01169103|B3|Baseline|Total|Total of all reporting groups
331293|NCT01169064|O2|Outcome|Cloth Dressing|
331294|NCT01169064|O1|Outcome|Silver Dressing|
351115|NCT01119755|O1|Outcome|Group 1|
331270|NCT01169103|B2|Baseline|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
331271|NCT01169103|B1|Baseline|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
331272|NCT01169103|P2|Participant Flow|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
331273|NCT01169103|P1|Participant Flow|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
331274|NCT01169103|O2|Outcome|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
331275|NCT01169103|O1|Outcome|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
331276|NCT01169103|O2|Outcome|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
331277|NCT01169103|O1|Outcome|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
331278|NCT01169103|O2|Outcome|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
331279|NCT01169103|O1|Outcome|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
331280|NCT01169103|O2|Outcome|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
331281|NCT01169103|O1|Outcome|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
331282|NCT01169103|O2|Outcome|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
331283|NCT01169103|O1|Outcome|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
331284|NCT01169103|E2|Reported Event|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
331285|NCT01169103|E1|Reported Event|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
331286|NCT01169064|B3|Baseline|Total|Total of all reporting groups
331287|NCT01169064|B2|Baseline|Cloth Adhesive Dressing|"Soft cloth adhesive wound dressing~Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days"
331288|NCT01169064|B1|Baseline|Silver-containing Surgical Dressing|"Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver~Silver-containing surgical dressing: Dressing placed over surgical incision and remain for 3-5 days"
331289|NCT01169064|P2|Participant Flow|Cloth Adhesive Dressing|"Soft cloth adhesive wound dressing~Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days"
331290|NCT01169064|P1|Participant Flow|Silver-containing Surgical Dressing|"Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver~Silver-containing surgical dressing: Dressing placed over surgical incision and remain for 3-5 days"
331291|NCT01169064|O2|Outcome|Cloth Adhesive Dressing|"Soft cloth adhesive wound dressing~Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days"
331292|NCT01169064|O1|Outcome|Silver-containing Surgical Dressing|"Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver~Silver-containing surgical dressing: Dressing placed over surgical incision and remain for 3-5 days"
331295|NCT01169064|O2|Outcome|Cloth Adhesive Dressing|"Soft cloth adhesive wound dressing~Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days"
331296|NCT01169064|O1|Outcome|Silver-containing Surgical Dressing|"Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver~Silver-containing surgical dressing: Dressing placed over surgical incision and remain for 3-5 days"
331297|NCT01169064|E2|Reported Event|Cloth Adhesive Dressing|"Soft cloth adhesive wound dressing~Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days~No adverse events"
331298|NCT01169064|E1|Reported Event|Silver-containing Surgical Dressing|"Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver~Silver-containing surgical dressing: Dressing placed over surgical incision and remain for 3-5 days~No adverse events"
331299|NCT01169038|B1|Baseline|Antibiotics|"Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD~**Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. **We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway."
331300|NCT01169038|P1|Participant Flow|Antibiotics|"Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD~**Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. **We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway."
331301|NCT01169038|O1|Outcome|Antibiotics|"Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD~**Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. **We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway."
331302|NCT01169038|E1|Reported Event|Antibiotics|"Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD~**Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. **We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway."
331303|NCT01168999|B5|Baseline|Total|Total of all reporting groups
331304|NCT01168999|B4|Baseline|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
331305|NCT01168999|B3|Baseline|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
331306|NCT01168999|B2|Baseline|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
331307|NCT01168999|B1|Baseline|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
331308|NCT01168999|P4|Participant Flow|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
331309|NCT01168999|P3|Participant Flow|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
331310|NCT01168999|P2|Participant Flow|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
331311|NCT01168999|P1|Participant Flow|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
331312|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
331313|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
331314|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
331315|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
331316|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
331317|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
331318|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
331319|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
331320|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
331321|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
331322|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
331323|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
331324|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
331325|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
331326|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
338676|NCT01149655|B3|Baseline|Total|Total of all reporting groups
331327|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
331328|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
331329|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
331330|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
331331|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
331332|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
331333|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
331334|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
331335|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
331336|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
331337|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
331338|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
331339|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
331340|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
331341|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
331342|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
331343|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
331344|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
331345|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
331346|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
331347|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
331348|NCT01168999|E4|Reported Event|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
331349|NCT01168999|E3|Reported Event|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
331350|NCT01168999|E2|Reported Event|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
331351|NCT01168999|E1|Reported Event|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
331352|NCT01168986|B4|Baseline|Total|Total of all reporting groups
331353|NCT01168986|B3|Baseline|No Intervention|Participants receive/perform no intervention
331354|NCT01168986|B2|Baseline|Exercise|"Participants perform an exercise to strengthen the deep neck flexors~Exercise: Participants perform an exercise to strengthen the deep neck flexors"
331355|NCT01168986|B1|Baseline|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.~Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
331356|NCT01168986|P3|Participant Flow|No Intervention|Participants receive/perform no intervention
331357|NCT01168986|P2|Participant Flow|Exercise|"Participants perform an exercise to strengthen the deep neck flexors~Exercise: Participants perform an exercise to strengthen the deep neck flexors"
331358|NCT01168986|P1|Participant Flow|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.~Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
331359|NCT01168986|O3|Outcome|No Intervention|Participants receive/perform no intervention
331360|NCT01168986|O2|Outcome|Exercise|"Participants perform an exercise to strengthen the deep neck flexors~Exercise: Participants perform an exercise to strengthen the deep neck flexors"
331361|NCT01168986|O1|Outcome|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.~Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
331362|NCT01168986|O3|Outcome|No Intervention|Participants receive/perform no intervention
331363|NCT01168986|O2|Outcome|Exercise|"Participants perform an exercise to strengthen the deep neck flexors~Exercise: Participants perform an exercise to strengthen the deep neck flexors"
331364|NCT01168986|O1|Outcome|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.~Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
331366|NCT01168986|O2|Outcome|Exercise|"Participants perform an exercise to strengthen the deep neck flexors~Exercise: Participants perform an exercise to strengthen the deep neck flexors"
331367|NCT01168986|O1|Outcome|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.~Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
331368|NCT01168986|O3|Outcome|No Intervention|Participants receive/perform no intervention
331369|NCT01168986|O2|Outcome|Exercise|"Participants perform an exercise to strengthen the deep neck flexors~Exercise: Participants perform an exercise to strengthen the deep neck flexors"
331370|NCT01168986|O1|Outcome|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.~Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
331371|NCT01168986|E3|Reported Event|No Intervention|Participants receive/perform no intervention
331372|NCT01168986|E2|Reported Event|Exercise|"Participants perform an exercise to strengthen the deep neck flexors~Exercise: Participants perform an exercise to strengthen the deep neck flexors"
331373|NCT01168986|E1|Reported Event|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.~Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
331374|NCT01168973|B3|Baseline|Total|Total of all reporting groups
331375|NCT01168973|B2|Baseline|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
331376|NCT01168973|B1|Baseline|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
331377|NCT01168973|P2|Participant Flow|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
331378|NCT01168973|P1|Participant Flow|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab drug product (DP) followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 milligrams per kilogram (mg/kg) administered intravenously.~Docetaxel: 75 milligrams per square meter (mg/m^2) (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
331379|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
331380|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
331381|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
331382|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
331383|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
331384|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
331385|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
331386|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
340636|NCT01144286|B1|Baseline|Placebo|placebo pessary, single dose
331387|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
331388|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
331389|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
331390|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
331391|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
331392|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
331393|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
331394|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
331395|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
331396|NCT01168973|E2|Reported Event|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
331397|NCT01168973|E1|Reported Event|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
331398|NCT01168934|B1|Baseline|Entire Study Population|Includes participants randomized to receive crizotinib 50 mg IV first and crizotinib 250 mg oral first.
331399|NCT01168934|P2|Participant Flow|Crizotinib 250 mg Oral First, Then Crizotinib 50 mg IV|Single oral dose of crizotinib 250 mg IRT in first intervention period; and single IV dose of crizotinib 50 mg in second intervention period. A washout period of at least 14 days was maintained between each period.
331400|NCT01168934|P1|Participant Flow|Crizotinib 50 mg IV First, Then Crizotinib 250 mg Oral|Single intravenous (IV) dose of crizotinib 50 milligram (mg) in first intervention period; and single oral dose of crizotinib 250 mg immediate release tablet (IRT) in second intervention period. A washout period of at least 14 days was maintained between each period.
331401|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
331402|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
331403|NCT01168934|O1|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
331404|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
331405|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
331406|NCT01168934|O1|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
331407|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
331408|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
331409|NCT01168934|O1|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
331410|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
351116|NCT01119755|O1|Outcome|Group 1|
331411|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
331412|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
331413|NCT01168934|O1|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
331414|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
331415|NCT01168934|O1|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
331416|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
331417|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
331418|NCT01168934|O1|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
331419|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
331420|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
331421|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
331422|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
331423|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
331424|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
331425|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
331426|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
331427|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
331428|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
331429|NCT01168934|E2|Reported Event|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
331430|NCT01168934|E1|Reported Event|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
331431|NCT01168908|B3|Baseline|Total|Total of all reporting groups
331432|NCT01168908|B2|Baseline|Placebo|"This arm will receive placebo (sugar pill) for 6 months and Revatio (sildenafil) for 6 months. During the first 6 months, the subject and investigator will be blinded to treatment. The second 6 months, will be open label treatment with Revatio.~Sildenafil: 20mg tablet three times daily"
331433|NCT01168908|B1|Baseline|Revatio (Sildenafil)|"This arm will receive Revatio (sildenafil) for 12 months. During the first 6 months, the subject and investigator will be blinded to treatment. The second 6 months, will be open label treatment with Revatio.~Sildenafil: 20mg tablet three times daily"
331434|NCT01168908|P2|Participant Flow|Placebo|"This arm will receive placebo (sugar pill) for 6 months and Revatio (sildenafil) for 6 months. During the first 6 months, the subject and investigator will be blinded to treatment. The second 6 months, will be open label treatment with Revatio.~Sildenafil: 20mg tablet three times daily"
331435|NCT01168908|P1|Participant Flow|Revatio (Sildenafil)|"This arm will receive Revatio (sildenafil) for 12 months. During the first 6 months, the subject and investigator will be blinded to treatment. The second 6 months, will be open label treatment with Revatio.~Sildenafil: 20mg tablet three times daily"
331436|NCT01168908|O2|Outcome|Placebo|"This arm will receive placebo (sugar pill) for 6 months and Revatio (sildenafil) for 6 months. During the first 6 months, the subject and investigator will be blinded to treatment. The second 6 months, will be open label treatment with Revatio.~Sildenafil: 20mg tablet three times daily"
331437|NCT01168908|O1|Outcome|Revatio (Sildenafil)|"This arm will receive Revatio (sildenafil) for 12 months. During the first 6 months, the subject and investigator will be blinded to treatment. The second 6 months, will be open label treatment with Revatio.~Sildenafil: 20mg tablet three times daily"
331438|NCT01168908|O2|Outcome|Placebo|"This arm will receive placebo (sugar pill) for 6 months and Revatio (sildenafil) for 6 months. During the first 6 months, the subject and investigator will be blinded to treatment. The second 6 months, will be open label treatment with Revatio.~Sildenafil: 20mg tablet three times daily"
331439|NCT01168908|O1|Outcome|Revatio (Sildenafil)|"This arm will receive Revatio (sildenafil) for 12 months. During the first 6 months, the subject and investigator will be blinded to treatment. The second 6 months, will be open label treatment with Revatio.~Sildenafil: 20mg tablet three times daily"
331440|NCT01168908|O2|Outcome|Placebo|"This arm will receive placebo (sugar pill) for 6 months and Revatio (sildenafil) for 6 months. During the first 6 months, the subject and investigator will be blinded to treatment. The second 6 months, will be open label treatment with Revatio.~Sildenafil: 20mg tablet three times daily"
331441|NCT01168908|O1|Outcome|Revatio (Sildenafil)|"This arm will receive Revatio (sildenafil) for 12 months. During the first 6 months, the subject and investigator will be blinded to treatment. The second 6 months, will be open label treatment with Revatio.~Sildenafil: 20mg tablet three times daily"
331442|NCT01168908|O2|Outcome|Placebo|"This arm will receive placebo (sugar pill) for 6 months and Revatio (sildenafil) for 6 months. During the first 6 months, the subject and investigator will be blinded to treatment. The second 6 months, will be open label treatment with Revatio.~Sildenafil: 20mg tablet three times daily"
331443|NCT01168908|O1|Outcome|Revatio (Sildenafil)|"This arm will receive Revatio (sildenafil) for 12 months. During the first 6 months, the subject and investigator will be blinded to treatment. The second 6 months, will be open label treatment with Revatio.~Sildenafil: 20mg tablet three times daily"
331444|NCT01168908|O2|Outcome|Placebo|"This arm will receive placebo (sugar pill) for 6 months and Revatio (sildenafil) for 6 months. During the first 6 months, the subject and investigator will be blinded to treatment. The second 6 months, will be open label treatment with Revatio.~Sildenafil: 20mg tablet three times daily"
342167|NCT01138657|B3|Baseline|Total|Total of all reporting groups
331445|NCT01168908|O1|Outcome|Revatio (Sildenafil)|"This arm will receive Revatio (sildenafil) for 12 months. During the first 6 months, the subject and investigator will be blinded to treatment. The second 6 months, will be open label treatment with Revatio.~Sildenafil: 20mg tablet three times daily"
331446|NCT01168908|E2|Reported Event|Placebo|"This arm will receive placebo (sugar pill) for 6 months and Revatio (sildenafil) for 6 months. During the first 6 months, the subject and investigator will be blinded to treatment. The second 6 months, will be open label treatment with Revatio.~Sildenafil: 20mg tablet three times daily"
331447|NCT01168908|E1|Reported Event|Revatio (Sildenafil)|"This arm will receive Revatio (sildenafil) for 12 months. During the first 6 months, the subject and investigator will be blinded to treatment. The second 6 months, will be open label treatment with Revatio.~Sildenafil: 20mg tablet three times daily"
331448|NCT01168856|B3|Baseline|Total|Total of all reporting groups
331449|NCT01168856|B2|Baseline|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
331450|NCT01168856|B1|Baseline|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331451|NCT01168856|P2|Participant Flow|Sustained Virological Response (SVR) Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved Sustained Virological Response (SVR), defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test greater than or equal to (≥) 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
331452|NCT01168856|P1|Participant Flow|Resistance Monitoring Arm|Participants enrolled into this arm were those with Hepatitis C Virus (HCV) infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed direct acting antiviral (DAA)-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331453|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV20536 [NCT00869661], WV21913 [NCT01331850], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], NP28266 [NCT01628094]. None of the enrolled patients had developed MCB-associated resistant mutation(s) in donor protocol. Participants were monitored up to 18 months.
331454|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV27779 [NCT01482390], NV27780 [NCT01482403]. Patients had developed BOC- or TVR-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
331455|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in the following donor protocol: NP28266 [NCT01628094]. Patients had developed STV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
331456|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV27779 [NCT01482390], NV27780 [NCT01482403]. Patients had developed BOC- or TVR-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
331457|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV21075 [NCT00963885], WV21913 [NCT01331850], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NP27946 [NCT01483742], NP28266 [NCT01628094]. Patients had developed DNV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
331458|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV21075 [NCT00963885], WV21913 [NCT01331850], NP22660 [NCT01185860], NV22776 [NCT01220947], PP25213 [NCT01278134], NP27946 [NCT01483742], NP28266 [NCT01628094]. Patients had developed DNV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
331459|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV21075 [NCT00963885], WV21913 [NCT01331850], NP22660 [NCT01185860], NV22776 [NCT01220947], PP25213 [NCT01278134], NP27946 [NCT01483742], NP28266 [NCT01628094]. Patients had developed DNV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
331460|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
331461|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
331462|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
331463|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
331464|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
331465|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
331466|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
331467|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
331468|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
331469|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
331470|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
331514|NCT01168726|P1|Participant Flow|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
331515|NCT01168726|O3|Outcome|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
331471|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
331472|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
331473|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
331474|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
331475|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
331476|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
331477|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
331478|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
331479|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
331480|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331481|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331482|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331483|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331484|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331485|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331486|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331487|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331488|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331489|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331490|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331516|NCT01168726|O2|Outcome|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
331491|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331492|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331493|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331494|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331495|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331496|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331497|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331498|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331499|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331546|NCT01168674|E1|Reported Event|Placebo|Placebo administered double-blind.
331547|NCT01168596|B3|Baseline|Total|Total of all reporting groups
331500|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331501|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331502|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331503|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331504|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331505|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
331506|NCT01168856|E2|Reported Event|SVR Durability Monitoring Arm|Participants enrolled into this study were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had Achieved Sustained Virological Response (SVR-24), defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test more than or equal to (≥) 20 weeks after the last dose of study medication.
331507|NCT01168856|E1|Reported Event|Resistance Monitoring Arm|Participants enrolled into this study were those with Hepatitis C Virus (HCV) infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed direct acting antiviral (DAA)-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations.
331508|NCT01168726|B4|Baseline|Total|Total of all reporting groups
331509|NCT01168726|B3|Baseline|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
331510|NCT01168726|B2|Baseline|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
331511|NCT01168726|B1|Baseline|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
331512|NCT01168726|P3|Participant Flow|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
331513|NCT01168726|P2|Participant Flow|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
331680|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331517|NCT01168726|O1|Outcome|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
331518|NCT01168726|O3|Outcome|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
331519|NCT01168726|O2|Outcome|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
331520|NCT01168726|O1|Outcome|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
331521|NCT01168726|O3|Outcome|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
331522|NCT01168726|O2|Outcome|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
331523|NCT01168726|O1|Outcome|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
331524|NCT01168726|O3|Outcome|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
331525|NCT01168726|O2|Outcome|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
331526|NCT01168726|O1|Outcome|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
331527|NCT01168726|E3|Reported Event|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
331528|NCT01168726|E2|Reported Event|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
331529|NCT01168726|E1|Reported Event|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
331530|NCT01168687|B3|Baseline|Total|Total of all reporting groups
331531|NCT01168687|B2|Baseline|Group B: Crossover Between High Dose Keppra and Placebo|"Group B: Twenty moderate to heavy social alcohol users (women 7-20 drinks/week --moderate 7-14 and heavy 15-20 and men 15-25 drinks/week --moderate 7-14 and heavy 15-25 drinks/week) will receive 500 mg levetiracetam BID (1000 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 1000 mg levetiracetam BID (2,000 mg per day) x 7 days.~Participants on active drug for the first 14 days then crossed over to placebo after a 10-14 day washout period. Similarly, participants on placebo for the first 14 days then crossed over to active drug after a 10-14 day washout period."
331532|NCT01168687|B1|Baseline|Group A: Crossover Between Low Dose Keppra and Placebo|Group A: Twenty moderate to heavy social alcohol users (women 7-20 drinks/week --moderate 7-14 and heavy 15-20 and men 15-25 drinks/week --moderate 7-14 and heavy 15-25 drinks/week) will receive 250 mg of levetiracetam BID (500 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 500 mg of levetiracetam BID (1,000 mg/day) or will receive a double dose of placebo x 7 days. Participants on active drug for the first 14 days then crossed over to placebo after a 10-14 day washout period. Similarly, participants on placebo for the first 14 days then crossed over to active drug after a 10-14 day washout period.
331533|NCT01168687|P2|Participant Flow|Group B: Crossover Between High Dose Keppra and Placebo|"Group B: Twenty moderate to heavy social alcohol users (women 7-20 drinks/week --moderate 7-14 and heavy 15-20 and men 15-25 drinks/week --moderate 7-14 and heavy 15-25 drinks/week) will receive 500 mg levetiracetam BID (1000 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 1000 mg levetiracetam BID (2,000 mg per day) x 7 days.~Participants on active drug for the first 14 days then crossed over to placebo after a 10-14 day washout period. Similarly, participants on placebo for the first 14 days then crossed over to active drug after a 10-14 day washout period."
331534|NCT01168687|P1|Participant Flow|Group A: Crossover Between Low Dose Keppra and Placebo|Group A: Twenty moderate to heavy social alcohol users (women 7-20 drinks/week --moderate 7-14 and heavy 15-20 and men 15-25 drinks/week --moderate 7-14 and heavy 15-25 drinks/week) will receive 250 mg of levetiracetam BID (500 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 500 mg of levetiracetam BID (1,000 mg/day) or will receive a double dose of placebo x 7 days. Participants on active drug for the first 14 days then crossed over to placebo after a 10-14 day washout period. Similarly, participants on placebo for the first 14 days then crossed over to active drug after a 10-14 day washout period.
331535|NCT01168687|O2|Outcome|All Subjects (n = 46) Levetiracetam|23 moderate social drinkers. 23 heavy social drinkers.
331536|NCT01168687|O1|Outcome|All Subjects (n = 46) Placebo|23 moderate social drinkers. 23 heavy social drinkers.
331537|NCT01168687|E2|Reported Event|All Subjects (n = 46) Levetiracetam|23 moderate social drinkers. 23 heavy social drinkers.
331538|NCT01168687|E1|Reported Event|All Subjects (n = 46) Placebo|23 moderate social drinkers. 23 heavy social drinkers.
331539|NCT01168674|B1|Baseline|All Study Participants|All participants were randomized to either placebo followed by ziprasidone crossover, or ziprsidone followed by placebo crossover.
331540|NCT01168674|P2|Participant Flow|Ziprasidone-washout-placebo|ziprasidone : Ziprasidone will be administered as a pill. The once-daily total daily dose will be 80-160 mg/d of ziprasidone. Dosing will begin at 20 mg BID with an escalation strategy based on target symptoms and tolerability, with a target dose range of 80-160 mg/d. Dose escalations will occur by increments of 20-40 mg weekly. This will be 6 weeks and then followed by a one week washout and then cross over to the other arm, Placebo, for another 6 weeks, using same dosing techniques.
331541|NCT01168674|P1|Participant Flow|Placebo-washout-ziprasidone|Placebo : The once-daily total daily dose will be 80-160 mg/d of the sugar pill. Dosing will begin at 20 mg BID with an escalation strategy based on target symptoms and tolerability, with a target dose range of 80-160 mg/d. Dose escalations will occur by increments of 20-40 mg weekly. This will be 6 weeks and then followed by a one week washout and then cross over to the other arm, Ziprazidone, for another 6 weeks, using same dosing techniques.
331542|NCT01168674|O1|Outcome|All Study Participants|All participants were randomized to either placebo followed by ziprasidone crossover, or ziprsidone followed by placebo crossover.
331543|NCT01168674|O2|Outcome|Ziprasidone|Subjects randomized to ziprasidone in either the initial or crossover phase.
331544|NCT01168674|O1|Outcome|Placebo|Subjects randomized to placebo in either the initial or crossover phase
331545|NCT01168674|E2|Reported Event|Ziprasidone|Active ziprasidone administered double-blind.
351117|NCT01119755|O1|Outcome|Group 1|
331548|NCT01168596|B2|Baseline|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
331549|NCT01168596|B1|Baseline|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
331550|NCT01168596|P2|Participant Flow|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
331551|NCT01168596|P1|Participant Flow|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
331552|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
331553|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
331554|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
331555|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
331556|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
331557|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
331558|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
331559|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
331560|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
331561|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
331562|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
331563|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
331564|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
331565|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
331566|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
331567|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
331568|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
331569|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
331570|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
331571|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
331572|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
331573|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
331574|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
331575|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
331576|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
331577|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
331681|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331578|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
331579|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
331580|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
331581|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
331582|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
331583|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
331584|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
331585|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
331586|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
331587|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
331588|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
331589|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
331590|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
331591|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
331592|NCT01168596|E2|Reported Event|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
331593|NCT01168596|E1|Reported Event|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
331594|NCT01168427|B1|Baseline|Enrollment Cohort|Enrollment cohort includes any patients who meet the inclusion and exclusion criteria and have a signed inform consent.
331595|NCT01168427|P1|Participant Flow|Enrollment Cohort|Enrollment cohort includes any patients who meet the inclusion and exclusion criteria and have a signed inform consent.
331596|NCT01168427|O1|Outcome|Implant Cohort|Patient with Reveal device implanted
331597|NCT01168427|O1|Outcome|Implant Cohort|Patient with Reveal device implanted
331598|NCT01168427|E1|Reported Event|Implant Cohort|Patient with Reveal device implanted
331599|NCT01168349|B1|Baseline|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331600|NCT01168349|P1|Participant Flow|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331601|NCT01168349|O9|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331602|NCT01168349|O8|Outcome|Chronic Lymphocytic Leukemia Participants|Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331603|NCT01168349|O7|Outcome|Hodgkin's Lymphoma Participants|Hodgkin’s lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331604|NCT01168349|O6|Outcome|Non-Hodgkin's Lymphoma Participants|Non-Hodgkin’s lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331605|NCT01168349|O5|Outcome|Multiple Myeloma Participants|Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331606|NCT01168349|O4|Outcome|Ovary Cancer Participants|Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331607|NCT01168349|O3|Outcome|Colon/Rectum Cancer Participants|Colon/rectum cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331608|NCT01168349|O2|Outcome|Breast Cancer Participants|Breast cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331609|NCT01168349|O1|Outcome|Lung Cancer Participants|Lung cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331610|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331611|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331612|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331613|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331614|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331615|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331616|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331617|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331618|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331619|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331620|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331621|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331622|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331623|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331624|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331625|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331626|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331627|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331628|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331629|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331630|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331631|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331632|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331633|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331634|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331635|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331636|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331637|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331638|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331639|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331640|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331641|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331642|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331643|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331644|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331645|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331646|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331647|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331648|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331649|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331650|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331651|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331652|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331653|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331654|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331655|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331656|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331657|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331658|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331659|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331660|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331661|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331662|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331663|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331664|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331665|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331666|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331667|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331668|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331669|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331670|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331671|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331672|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331673|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331674|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331675|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331676|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331677|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331678|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331679|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331682|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331683|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331684|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331685|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331686|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331687|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331688|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331689|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331690|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331691|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331692|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331693|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331694|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331695|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
331696|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331697|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331698|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331699|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331700|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia [CLL], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331701|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331702|NCT01168349|E3|Reported Event|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331703|NCT01168349|E2|Reported Event|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331704|NCT01168349|E1|Reported Event|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
331705|NCT01168232|B1|Baseline|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
331706|NCT01168232|P1|Participant Flow|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
331707|NCT01168232|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
331821|NCT01167608|P1|Participant Flow|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study. : No intervention.
331708|NCT01168232|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
331709|NCT01168232|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
331710|NCT01168232|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
331711|NCT01168232|E1|Reported Event|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
331712|NCT01168219|B1|Baseline|Treatment (Chemotherapy and Transplant)|"REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor [MSD]) or -6 to -4 (matched unrelated donor [MUD]).~TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD).~CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1."
331713|NCT01168219|P1|Participant Flow|Treatment (Chemotherapy and Transplant)|"REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor [MSD]) or -6 to -4 (matched unrelated donor [MUD]).~TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD).~CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1."
331714|NCT01168219|O1|Outcome|Treatment (Chemotherapy and Transplant)|"REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor [MSD]) or -6 to -4 (matched unrelated donor [MUD]).~TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD).~CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1."
331715|NCT01168219|E1|Reported Event|Treatment (Chemotherapy and Transplant)|"REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor [MSD]) or -6 to -4 (matched unrelated donor [MUD]).~TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD).~CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1."
331716|NCT01168024|B3|Baseline|Total|Total of all reporting groups
331717|NCT01168024|B2|Baseline|Standard of Care|"Peri-procedural hydration with isotonic saline or sodium bicarbonate for at least 2 hours prior to the procedure and 6-12 hours post-procedure.~Peri-procedural hydration: The control group will receive a peri and post-procedural hydration rate."
331718|NCT01168024|B1|Baseline|CINCOR™ System Treatment|"Use of the CINCOR™ System and CCS-1 device during the PCI procedure plus Standard of Care peri-procedural hydration for the prevention of CIN.~CINCOR™ System and CCS-1: Catheter based system to reduce and remove contrast media and contrast modulator to reduce contrast media~Peri-procedural hydration: The control group will receive a peri and post-procedural hydration rate."
331719|NCT01168024|P2|Participant Flow|Standard of Care Plus Peri-procedural Hydration|Peri-procedural hydration utilized prior to standard of care PCI.
331720|NCT01168024|P1|Participant Flow|CINCOR™ System and CCS-1|Use of the CINCOR™ System and CCS-1 device during the PCI procedure plus Standard of Care peri-procedural hydration for the prevention of CIN.
331721|NCT01168024|O2|Outcome|Control|Peri-procedure hydration
331722|NCT01168024|O1|Outcome|Treatment (Roll In and Randomized)|CINCOR, CCS-1 and Peri-procedure hydration
331723|NCT01168024|O2|Outcome|Control|Peri-procedure hydration
331724|NCT01168024|O1|Outcome|Treatment (Roll In and Randomized)|CINCOR, CCS-1 and Peri-procedure hydration
331725|NCT01168024|O2|Outcome|Control|Peri-procedure hydration
331726|NCT01168024|O1|Outcome|Treatment (Roll In and Randomized)|CINCOR, CCS-1 and Peri-procedure hydration
331727|NCT01168024|O2|Outcome|Control|Peri-procedure hydration
331728|NCT01168024|O1|Outcome|Treatment (Roll In and Randomized)|CINCOR, CCS-1 and Peri-procedure hydration
331729|NCT01168024|E2|Reported Event|Control|Peri-procedure hydration
331730|NCT01168024|E1|Reported Event|Treatment (Roll In and Randomized)|CINCOR, CCS-1 and Peri-procedure hydration
331731|NCT01167907|B3|Baseline|Total|Total of all reporting groups
331732|NCT01167907|B2|Baseline|Saline|"Patients with evidence of sciatic and saphenous nerve block will be randomized to receive a postoperative continuous infusion of either saline (control) or 0.2% ropivacaine by elastomeric infusion pump at 5ml/h started within 6h of catheter placement.~saline: saline (control) by elastomeric infusion pump at 5ml/h started within 6h of catheter placement"
331733|NCT01167907|B1|Baseline|0.2% Ropivacaine|"Patients with evidence of sciatic and saphenous nerve block will be randomized to receive a postoperative continuous infusion of either saline (control) or 0.2% ropivacaine by elastomeric infusion pump at 5ml/h started within 6h of catheter placement.~0.2% ropivacaine: 0.2% ropivacaine by elastomeric infusion pump at 5ml/h started within 6h of catheter placement~saline: saline (control) by elastomeric infusion pump at 5ml/h started within 6h of catheter placement"
331734|NCT01167907|P2|Participant Flow|Saline|Patients with evidence of sciatic and saphenous nerve block will be administered saline by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
331822|NCT01167608|O1|Outcome|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study.: No intervention.
331735|NCT01167907|P1|Participant Flow|0.2% Ropivacaine|Patients with evidence of sciatic and saphenous nerve block will be administered 0.2% ropivacaine by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
331736|NCT01167907|O2|Outcome|Saline|Patients with evidence of sciatic and saphenous nerve block will be administered saline by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
331737|NCT01167907|O1|Outcome|0.2% Ropivacaine|Patients with evidence of sciatic and saphenous nerve block will be administered 0.2% ropivacaine by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
331738|NCT01167907|O2|Outcome|Saline|Patients with evidence of sciatic and saphenous nerve block will be administered saline by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
331739|NCT01167907|O1|Outcome|0.2% Ropivacaine|Patients with evidence of sciatic and saphenous nerve block will be administered 0.2% ropivacaine by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
331740|NCT01167907|O2|Outcome|Saline|Patients with evidence of sciatic and saphenous nerve block will be administered saline by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
331741|NCT01167907|O1|Outcome|0.2% Ropivacaine|Patients with evidence of sciatic and saphenous nerve block will be administered 0.2% ropivacaine by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
331742|NCT01167907|O2|Outcome|Saline|Patients with evidence of sciatic and saphenous nerve block will be administered saline by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
331743|NCT01167907|O1|Outcome|0.2% Ropivacaine|Patients with evidence of sciatic and saphenous nerve block will be administered 0.2% ropivacaine by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
331744|NCT01167907|O2|Outcome|Saline|Patients with evidence of sciatic and saphenous nerve block will be administered saline by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
331745|NCT01167907|O1|Outcome|0.2% Ropivacaine|Patients with evidence of sciatic and saphenous nerve block will be administered 0.2% ropivacaine by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
331746|NCT01167907|O2|Outcome|Saline|Patients with evidence of sciatic and saphenous nerve block will be administered saline by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
331747|NCT01167907|O1|Outcome|0.2% Ropivacaine|Patients with evidence of sciatic and saphenous nerve block will be administered 0.2% ropivacaine by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
331748|NCT01167907|E2|Reported Event|Saline|Patients with evidence of sciatic and saphenous nerve block will be administered saline by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
331749|NCT01167907|E1|Reported Event|0.2% Ropivacaine|Patients with evidence of sciatic and saphenous nerve block will be administered 0.2% ropivacaine by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
331750|NCT01167881|B3|Baseline|Total|Total of all reporting groups
331751|NCT01167881|B2|Baseline|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
331752|NCT01167881|B1|Baseline|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
331753|NCT01167881|P2|Participant Flow|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
331754|NCT01167881|P1|Participant Flow|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
331755|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
331756|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
331757|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
331758|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
331759|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
331760|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
331761|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
331762|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
331763|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
331764|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
331765|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
331766|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
331767|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
331768|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
331769|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
331770|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
331771|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
331772|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
331773|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
331774|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
331775|NCT01167881|E2|Reported Event|Glimepiride|Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin
331776|NCT01167881|E1|Reported Event|Empa 25mg|Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride
331777|NCT01167829|B1|Baseline|Acyline and Oral Testosterone|300 mcg/kg acyline, and modified slow-release oral testosterone 300 mg
331778|NCT01167829|P1|Participant Flow|Acyline and 0ral Testosterone|Acyline 300 mcg/kg subcutaneous + 300mg modified slow-release oral testosterone tid
331779|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
331780|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
331781|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
331782|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
331783|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
331784|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
331785|NCT01167829|O1|Outcome|Acyline and 300 mg Oral Testosterone|300 mg oral testosterone three times daily
331786|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
331787|NCT01167829|O1|Outcome|Acyine and 300 mg Oral Testosterone|300 mg oral testosterone three times daily
331788|NCT01167829|O1|Outcome|Acyline and 300 mg Oral Testosterone|300 mg oral testosterone three times daily
331789|NCT01167829|E1|Reported Event|Acyline and Oral Testosterone|300 mcg/kg acyline, and modified slow-release oral testosterone 300 mg
331790|NCT01167712|B3|Baseline|Total|Total of all reporting groups
331791|NCT01167712|B2|Baseline|Arm II (Neoadjuvant Chemotherapy)|"Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4.~Bevacizumab: Given IV~Carboplatin: Given IV~Computed Tomography: Correlative studies~Paclitaxel: Given IV~Therapeutic Conventional Surgery: Undergo surgery"
331792|NCT01167712|B1|Baseline|Arm I (Adjuvant Chemotherapy Suboptimally Debulked)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.~Bevacizumab: Given IV~Carboplatin: Given IV~Computed Tomography: Correlative studies~Paclitaxel: Given IV~Therapeutic Conventional Surgery: Undergo surgery"
331793|NCT01167712|P2|Participant Flow|Arm II (Neoadjuvant Chemotherapy)|"Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4.~Bevacizumab: Given IV~Carboplatin: Given IV~Computed Tomography: Correlative studies~Paclitaxel: Given IV~Therapeutic Conventional Surgery: Undergo surgery"
331794|NCT01167712|P1|Participant Flow|Arm I (Adjuvant Chemotherapy Suboptimally Debulked)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.~Bevacizumab: Given IV~Carboplatin: Given IV~Computed Tomography: Correlative studies~Paclitaxel: Given IV"
331795|NCT01167712|O2|Outcome|Arm II (Neoadjuvant Chemotherapy)|"Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4.~Bevacizumab: Given IV~Carboplatin: Given IV~Computed Tomography: Correlative studies~Paclitaxel: Given IV~Therapeutic Conventional Surgery: Undergo surgery"
331819|NCT01167634|E1|Reported Event|1 - Control|"Control - no financial incentive or match~Participants are given the goal of losing 1 pound per week for 24 weeks are asked to weigh-in monthly with no financial incentive."
331796|NCT01167712|O1|Outcome|Arm I (Adjuvant Chemotherapy Suboptimally Debulked)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.~Bevacizumab: Given IV~Carboplatin: Given IV~Computed Tomography: Correlative studies~Paclitaxel: Given IV"
331797|NCT01167712|O2|Outcome|Arm II (Neoadjuvant Chemotherapy)|"Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4.~Bevacizumab: Given IV~Carboplatin: Given IV~Computed Tomography: Correlative studies~Paclitaxel: Given IV~Therapeutic Conventional Surgery: Undergo surgery"
331798|NCT01167712|O1|Outcome|Arm I (Adjuvant Chemotherapy Suboptimally Debulked)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.~Bevacizumab: Given IV~Carboplatin: Given IV~Computed Tomography: Correlative studies~Paclitaxel: Given IV"
331799|NCT01167712|O2|Outcome|Arm II (Neoadjuvant Chemotherapy)|"Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4.~Bevacizumab: Given IV~Carboplatin: Given IV~Computed Tomography: Correlative studies~Paclitaxel: Given IV~Therapeutic Conventional Surgery: Undergo surgery"
331800|NCT01167712|O1|Outcome|Arm I (Adjuvant Chemotherapy Suboptimally Debulked)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.~Bevacizumab: Given IV~Carboplatin: Given IV~Computed Tomography: Correlative studies~Paclitaxel: Given IV"
331801|NCT01167712|E2|Reported Event|Arm II (Neoadjuvant Chemotherapy)|"Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4.~Bevacizumab: Given IV~Carboplatin: Given IV~Computed Tomography: Correlative studies~Paclitaxel: Given IV~Therapeutic Conventional Surgery: Undergo surgery"
331802|NCT01167712|E1|Reported Event|Arm I (Adjuvant Chemotherapy Suboptimally Debulked)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.~Bevacizumab: Given IV~Carboplatin: Given IV~Computed Tomography: Correlative studies~Paclitaxel: Given IV"
331803|NCT01167634|B5|Baseline|Total|Total of all reporting groups
331804|NCT01167634|B4|Baseline|Experimental 4 - Deposit With no Match|"Deposit contract with no match~Deposit Contract with no match: Daily weigh-in for 24 weeks and if each daily goal met the daily deposit amount is paid back. Final weigh-in at 36 weeks with no financial incentive or deposit made."
331805|NCT01167634|B3|Baseline|3 - Deposit Contract With a 2:1 Match|"Deposit contract with a 2:1 match~Deposit contract with a 2:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount twice the amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made."
331806|NCT01167634|B2|Baseline|2 - Deposit Contract With a 1:1 Match|"Deposit contract with a 1:1 match~Deposit contract with a 1:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made."
331807|NCT01167634|B1|Baseline|1 - Control|
331808|NCT01167634|P4|Participant Flow|Experimental 4 - Deposit With no Match|"Deposit contract with no match~Deposit Contract with no match: Daily weigh-in for 24 weeks and if each daily goal met the daily deposit amount is paid back. Final weigh-in at 36 weeks with no financial incentive or deposit made."
331809|NCT01167634|P3|Participant Flow|3 - Deposit Contract With a 2:1 Match|"Deposit contract with a 2:1 match~Deposit contract with a 2:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount twice the amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made."
331810|NCT01167634|P2|Participant Flow|2 - Deposit Contract With a 1:1 Match|"Deposit contract with a 1:1 match~Deposit contract with a 1:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made."
331811|NCT01167634|P1|Participant Flow|1 - Control|"Control - no financial incentive or match~Participants are given the goal of losing 1 pound per week for 24 weeks are asked to weigh-in monthly with no financial incentive."
331812|NCT01167634|O4|Outcome|Experimental 4 - Deposit With no Match|"Deposit contract with no match~Deposit Contract with no match: Daily weigh-in for 24 weeks and if each daily goal met the daily deposit amount is paid back. Final weigh-in at 36 weeks with no financial incentive or deposit made."
331813|NCT01167634|O3|Outcome|3 - Deposit Contract With a 2:1 Match|"Deposit contract with a 2:1 match~Deposit contract with a 2:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount twice the amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made."
331814|NCT01167634|O2|Outcome|2 - Deposit Contract With a 1:1 Match|"Deposit contract with a 1:1 match~Deposit contract with a 1:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made."
331815|NCT01167634|O1|Outcome|1 - Control|Usual care arm
331816|NCT01167634|E4|Reported Event|Experimental 4 - Deposit Contract With no Match|"Deposit contract with no match~Deposit Contract with no match: Daily weigh-in for 24 weeks and if each daily goal met the daily deposit amount is paid back. Final weigh-in at 36 weeks with no financial incentive or deposit made."
331817|NCT01167634|E3|Reported Event|3 - Deposit Contract With a 2:1 Match|"Deposit contract with a 2:1 match~Deposit contract with a 2:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount twice the amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made."
331818|NCT01167634|E2|Reported Event|2 - Deposit Contract With a 1:1 Match|"Deposit contract with a 1:1 match~Deposit contract with a 1:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made."
331820|NCT01167608|B1|Baseline|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study. : No intervention.
331823|NCT01167608|O1|Outcome|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study.: No intervention.
331824|NCT01167608|O1|Outcome|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study.: No intervention.
331825|NCT01167608|O1|Outcome|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study.: No intervention.
331826|NCT01167608|O1|Outcome|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study.: No intervention.
331827|NCT01167608|O1|Outcome|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study. : No intervention.
331828|NCT01167608|E1|Reported Event|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study. : No intervention.
331829|NCT01167582|B3|Baseline|Total|Total of all reporting groups
331830|NCT01167582|B2|Baseline|Restrictive Transfusion Strategy|Patients transfused if they develop symptoms related to anemia or at physician discretion if the hemoglobin concentration falls below 8 g/dL.
331831|NCT01167582|B1|Baseline|Liberal Transfusion Strategy|Patients receive red blood cell transfusion to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days
331832|NCT01167582|P2|Participant Flow|Restrictive Transfusion Strategy|"Receive a transfusion if they develop symptoms related to anemia. Transfusion is also permitted, but not required, in the absence of symptoms only if the hemoglobin concentration falls below 8 g/dL. Blood is administered one unit at a time and the presence of symptoms is reassessed. Only enough blood is given to relieve symptoms. If the transfusion is given because the hemoglobin concentration falls below 8 g/dL, then only enough blood is given to increase the hemoglobin concentration above 8 g/dL.~Symptoms of anemia that will be indications for transfusion are: 1) Definite angina requiring treatment with sublingual nitroglycerin or equivalent therapy. 2) Unexplained tachycardia or hypotension."
331833|NCT01167582|P1|Participant Flow|Liberal Transfusion Strategy|Patients randomly allocated to the liberal transfusion strategy receive one unit of packed red cells following randomization and receive enough blood to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Any transfusion following the initial unit of packed red cells must be preceded by blood test documenting a hemoglobin concentration below 10 g/dL.
331834|NCT01167582|O2|Outcome|Restrictive Transfusion Strategy|Patients transfused if they develop symptoms related to anemia or at physician discretion if the hemoglobin concentration falls below 8 g/dL
331835|NCT01167582|O1|Outcome|Liberal Transfusion Strategy|Patients receive red blood cell transfusion to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days
331836|NCT01167582|O2|Outcome|Restrictive Transfusion Strategy|Patients transfused if they develop symptoms related to anemia or at physician discretion if the hemoglobin concentration falls below 8 g/dL
331837|NCT01167582|O1|Outcome|Liberal Transfusion Strategy|Patients receive red blood cell transfusion to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days
331838|NCT01167582|O2|Outcome|Restrictive Transfusion Strategy|Patients transfused if they develop symptoms related to anemia or at physician discretion if the hemoglobin concentration falls below 8 g/dL.
331839|NCT01167582|O1|Outcome|Liberal Transfusion Strategy|Patients receive red blood cell transfusion to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days
331840|NCT01167582|O2|Outcome|Restrictive Transfusion Strategy|Patients transfused if they develop symptoms related to anemia or at physician discretion if the hemoglobin concentration falls below 8 g/dL.
331841|NCT01167582|O1|Outcome|Liberal Transfusion Strategy|Patients receive red blood cell transfusion to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days
331842|NCT01167582|E2|Reported Event|Restrictive Transfusion Strategy|Patients transfused if they develop symptoms related to anemia or at physician discretion if the hemoglobin concentration falls below 8 g/dL.
331843|NCT01167582|E1|Reported Event|Liberal Transfusion Strategy|Patients receive red blood cell transfusion to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days
331844|NCT01167504|B1|Baseline|Saliva Sample Collection|Collection of whole mouth and parotid saliva
331845|NCT01167504|P1|Participant Flow|Saliva Sample Collection|Collection of whole mouth and parotid saliva samples
331846|NCT01167504|O1|Outcome|Saliva Sample Collection|Collection of whole mouth and parotid saliva samples
331847|NCT01167504|O1|Outcome|Saliva Sample Collection|Collection of whole mouth and parotid saliva samples
331848|NCT01167504|E1|Reported Event|Saliva Sample Collection|Collection of whole mouth and parotid saliva samples
331849|NCT01167452|B1|Baseline|Sulfamethoxazole/Trimethoprim|All volunteers received a single dose oral dose of TMP/SMX (1600 mg/320 mg).
331850|NCT01167452|P1|Participant Flow|Sulfamethoxazole/Trimethoprim|"2 DS tablets of sulfamehtoxazole/trimethoprim (1600 mg/320 mg)~Sulfamethoxazole/trimethoprim: 2 DS tablets of trimethoprim/sulfamethoxazole x 1 dose"
331851|NCT01167452|O2|Outcome|Trimethoprim|Results from trimethoprim analysis
331852|NCT01167452|O1|Outcome|Sulfamethoxazole|Results from sulfamethoxazole analysis
331853|NCT01167452|E1|Reported Event|Sulfamethoxazole/Trimethoprim|All volunteers received a single dose of TMP/SMX (1600 mg/320 mg).
331854|NCT01167426|B1|Baseline|Glatiramer Acetate|Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
331855|NCT01167426|P1|Participant Flow|Glatiramer Acetate|Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
331951|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
331955|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
331856|NCT01167426|O1|Outcome|Glatiramer Acetate|Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
331857|NCT01167426|O1|Outcome|Glatiramer Acetate|Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
331858|NCT01167426|E2|Reported Event|Period 2: Glatirimer Actetate|Participants received once daily subcutaneous administration of glatiramer acetate 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
331859|NCT01167426|E1|Reported Event|Period 1: Glatiramer Acetate 20 mg/1.0 mL|Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1).
331860|NCT01167257|B3|Baseline|Total|Total of all reporting groups
331861|NCT01167257|B2|Baseline|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation"
331862|NCT01167257|B1|Baseline|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80mg/40ml) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
331863|NCT01167257|P2|Participant Flow|Control Arm|"Normal saline 50ml in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation"
331864|NCT01167257|P1|Participant Flow|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
331865|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
331866|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A ( mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
331867|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation"
331868|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
331869|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
331870|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A ( mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
331871|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
331872|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 Ll water) in single intravesical instillation, one time treatment at the treatment day"
331873|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
331874|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
331875|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
331876|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10ml in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
331877|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation"
331878|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
331879|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation"
331880|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
331881|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
331952|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
331953|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
331882|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
331883|NCT01167257|E2|Reported Event|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation'~Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
331884|NCT01167257|E1|Reported Event|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A'~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
331885|NCT01167192|B1|Baseline|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
331886|NCT01167192|P1|Participant Flow|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
331887|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
331888|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
331889|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
331890|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
331891|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
331892|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
331893|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
331894|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
331895|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
331896|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
331897|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
331898|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
331954|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
343092|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
331899|NCT01167192|E1|Reported Event|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
331900|NCT01167179|B3|Baseline|Total|Total of all reporting groups
331901|NCT01167179|B2|Baseline|Intervention|The intervention consisted of six 30-minute nursing follow-up consultations in the first year posttreatment. A standardized protocol was used for this purpose. Nursing consultations were conducted in parallel with and preceding the medical routine control visits and included a needs assessment based upon the biopsychosocial model. The aim of consultation was to give advice and support to patients (and their partners) addressing the physical and psychosocial consequences of treatment. To increase patient focus and active participation during consultations, patients completed a 13-item checklist prior to each consultation.Every 3 months, patients were screened for psychosocial problem areas using a specific questionnaire.During the consultations, the nurses also performed simple medical checks including inspection of the tracheal stoma, cannula and speech valve (if applicable), and oral cavity, and palpation of the neck and lymph nodes.
331902|NCT01167179|B1|Baseline|Usual Care|The participants in the comparison group received usual care that consisted of a 5-year routine control schedule with six bimonthly 10-minute visits to a head and neck surgeon in the first year posttreatment in accordance with national guidelines.19 Nursing follow-up care consisted of ad hoc problem-based contacts except for patients who underwent a laryngectomy, who received standard nursing consultations during the first 6 months posttreatment in parallel with the medical control visits. Patients who were treated with surgery alone all had one standard wound control visit with a nurse; patients who were treated with radiotherapy had one to six ad hoc nursing contacts during the first 6 months posttreatment. For the duration of the study, there were no changes in conventional care.
331903|NCT01167179|P2|Participant Flow|Intervention|"The intervention consisted of six 30-minute nursing follow-up consultations in the first year posttreatment. A standardized protocol was used for this purpose. Nursing consultations were conducted in parallel with and preceding the medical routine control visits and included a needs assessment based upon the biopsychosocial model.The aim of consultation was to give advice and support to patients (and their partners) addressing the physical and psychosocial consequences of treatment. To increase patient focus and active participation during consultations, patients completed a 13-item checklist prior to each consultation. Every 3 months, patients were screened for psychosocial problem areas using a specific questionnaire.~During the consultations, the nurses also performed simple medical checks including inspection of the tracheal stoma, cannula and speech valve (if applicable), and oral cavity, and palpation of the neck and lymph nodes."
331904|NCT01167179|P1|Participant Flow|Usual Care|The participants in the usual care group received care that consisted of a 5-year routine control schedule with six bimonthly 10-minute visits to a head and neck surgeon in the first year posttreatment in accordance with national guidelines.19 Nursing follow-up care consisted of ad hoc problem-based contacts except for patients who underwent a laryngectomy, who received standard nursing consultations during the first 6 months posttreatment in parallel with the medical control visits. Patients who were treated with surgery alone all had one standard wound control visit with a nurse; patients who were treated with radiotherapy had one to six ad hoc nursing contacts during the first 6 months posttreatment. For the duration of the study, there were no changes in usual care.
331905|NCT01167179|O2|Outcome|Intervention|The intervention consisted of six 30-minute nursing follow-up consultations in the first year posttreatment. A standardized protocol was used for this purpose. Nursing consultations were conducted in parallel with and preceding the medical routine control visits and included a needs assessment based upon the biopsychosocial model. The aim of consultation was to give advice and support to patients (and their partners) addressing the physical and psychosocial consequences of treatment. To increase patient focus and active participation during consultations, patients completed a 13-item checklist prior to each consultation.Every 3 months, patients were screened for psychosocial problem areas using a specific questionnaire.During the consultations, the nurses also performed simple medical checks including inspection of the tracheal stoma, cannula and speech valve (if applicable), and oral cavity, and palpation of the neck and lymph nodes.
331906|NCT01167179|O1|Outcome|Usual Care|The participants in the comparison group received usual care that consisted of a 5-year routine control schedule with six bimonthly 10-minute visits to a head and neck surgeon in the first year posttreatment in accordance with national guidelines.19 Nursing follow-up care consisted of ad hoc problem-based contacts except for patients who underwent a laryngectomy, who received standard nursing consultations during the first 6 months posttreatment in parallel with the medical control visits. Patients who were treated with surgery alone all had one standard wound control visit with a nurse; patients who were treated with radiotherapy had one to six ad hoc nursing contacts during the first 6 months posttreatment. For the duration of the study, there were no changes in conventional care.
331907|NCT01167179|O2|Outcome|Intervention|The intervention consisted of six 30-minute nursing follow-up consultations in the first year posttreatment. A standardized protocol was used for this purpose. Nursing consultations were conducted in parallel with and preceding the medical routine control visits and included a needs assessment based upon the biopsychosocial model. The aim of consultation was to give advice and support to patients (and their partners) addressing the physical and psychosocial consequences of treatment. To increase patient focus and active participation during consultations, patients completed a 13-item checklist prior to each consultation.Every 3 months, patients were screened for psychosocial problem areas using a specific questionnaire.During the consultations, the nurses also performed simple medical checks including inspection of the tracheal stoma, cannula and speech valve (if applicable), and oral cavity, and palpation of the neck and lymph nodes.
331908|NCT01167179|O1|Outcome|Usual Care|The participants in the comparison group received usual care that consisted of a 5-year routine control schedule with six bimonthly 10-minute visits to a head and neck surgeon in the first year posttreatment in accordance with national guidelines.19 Nursing follow-up care consisted of ad hoc problem-based contacts except for patients who underwent a laryngectomy, who received standard nursing consultations during the first 6 months posttreatment in parallel with the medical control visits. Patients who were treated with surgery alone all had one standard wound control visit with a nurse; patients who were treated with radiotherapy had one to six ad hoc nursing contacts during the first 6 months posttreatment. For the duration of the study, there were no changes in conventional care.
331909|NCT01167179|E2|Reported Event|Intervention|The intervention consisted of six 30-minute nursing follow-up consultations in the first year posttreatment. A standardized protocol was used for this purpose. Nursing consultations were conducted in parallel with and preceding the medical routine control visits and included a needs assessment based upon the biopsychosocial model. The aim of consultation was to give advice and support to patients (and their partners) addressing the physical and psychosocial consequences of treatment. To increase patient focus and active participation during consultations, patients completed a 13-item checklist prior to each consultation.Every 3 months, patients were screened for psychosocial problem areas using a specific questionnaire.During the consultations, the nurses also performed simple medical checks including inspection of the tracheal stoma, cannula and speech valve (if applicable), and oral cavity, and palpation of the neck and lymph nodes.
331910|NCT01167179|E1|Reported Event|Usual Care|The participants in the comparison group received usual care that consisted of a 5-year routine control schedule with six bimonthly 10-minute visits to a head and neck surgeon in the first year posttreatment in accordance with national guidelines.19 Nursing follow-up care consisted of ad hoc problem-based contacts except for patients who underwent a laryngectomy, who received standard nursing consultations during the first 6 months posttreatment in parallel with the medical control visits. Patients who were treated with surgery alone all had one standard wound control visit with a nurse; patients who were treated with radiotherapy had one to six ad hoc nursing contacts during the first 6 months posttreatment. For the duration of the study, there were no changes in conventional care.
331911|NCT01167153|B3|Baseline|Total|Total of all reporting groups
331912|NCT01167153|B2|Baseline|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
331913|NCT01167153|B1|Baseline|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
331914|NCT01167153|P2|Participant Flow|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
331915|NCT01167153|P1|Participant Flow|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
331916|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
331917|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
331918|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
331919|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
331920|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
331921|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
331922|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
331923|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
331924|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
331925|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
331926|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
331927|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
331928|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
331929|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
331930|NCT01167153|E2|Reported Event|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
331931|NCT01167153|E1|Reported Event|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
331932|NCT01167140|B1|Baseline|Group 1|
331933|NCT01167140|P1|Participant Flow|Treatment Group|
331934|NCT01167140|O1|Outcome|Treatment Group|
331935|NCT01167140|O1|Outcome|Treatment Group|
331936|NCT01167140|O1|Outcome|Treatment Group|
331937|NCT01167140|E1|Reported Event|Treatment Group|
331938|NCT01167023|B3|Baseline|Total|Total of all reporting groups
331939|NCT01167023|B2|Baseline|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
331940|NCT01167023|B1|Baseline|Placebo|Participants received placebo orally, once daily for 30 days.
331941|NCT01167023|P3|Participant Flow|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
331942|NCT01167023|P2|Participant Flow|Placebo|Participants received placebo orally, once daily for 30 days.
331943|NCT01167023|P1|Participant Flow|7.5 mg Prasugrel|Participants were to receive 7.5 milligrams (mg) of prasugrel orally, once daily if they weighed ≥60 kilograms (kg) and if pharmacodynamic (PD) measures indicated that the 5-mg prasugrel dose did not produce a steady-state PD response equivalent to inhibition of platelet activation (IPA) ≥25%. Because these criteria were not met, no participants received 7.5 mg of prasugrel.
331944|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
331945|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
331946|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
331947|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
331948|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
331949|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
331950|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
331956|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
331957|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
331958|NCT01167023|E2|Reported Event|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
331959|NCT01167023|E1|Reported Event|Placebo|Participants received placebo orally, once daily for 30 days.
331960|NCT01166997|B3|Baseline|Total|Total of all reporting groups
331961|NCT01166997|B2|Baseline|UFH + EkoSonic Procedure|Patients in this arm received anticoagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System was used to deliver a low dose of <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
331962|NCT01166997|B1|Baseline|UFH (Alone)|Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
331963|NCT01166997|P2|Participant Flow|Unfractionated Heparin (UFH) + EkoSonic Procedure|Patients in this arm received anticoagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System was used to deliver a low dose of <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
331964|NCT01166997|P1|Participant Flow|Unfractionated Heparin (UFH) Alone|Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
331965|NCT01166997|O2|Outcome|Intravenous Unfractionated Heparin|"Patients in this arm will receive the standard of care: intravenous unfractionated heparin used as anti-coagulation treatment.~Unfractionated heparin: Intravenous unfractionated heparin used for anticoagulation treatment"
331966|NCT01166997|O1|Outcome|Ultrasound Accelerated Thrombolysis|"Patients in this arm will receive anti-coagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System will be used to deliver a low dose <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.~EkoSonic Endovascular System: The EkoSonic Endovascular System will be used to deliver < 20 mg of rt-PA ( Actilyse) directly into the occlusive pulmonary thrombus."
331967|NCT01166997|O2|Outcome|Unfractionated Heprin + EkoSonic Procedure|Patients in this arm received anti-coagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System was used to deliver a low dose of <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
331968|NCT01166997|O1|Outcome|Unfractionated Heparin (UFH) Alone|Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
331969|NCT01166997|E2|Reported Event|UFH + EkoSonic|Patients in this arm received anticoagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System was used to deliver a low dose of <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
331970|NCT01166997|E1|Reported Event|Unfractionated Heparin (UFH) Alone|Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
331971|NCT01166971|B3|Baseline|Total|Total of all reporting groups
331972|NCT01166971|B2|Baseline|Tecnis MF|Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
331973|NCT01166971|B1|Baseline|ReSTOR +3|Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
331974|NCT01166971|P2|Participant Flow|Tecnis MF|Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
331975|NCT01166971|P1|Participant Flow|ReSTOR +3|Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
331976|NCT01166971|O2|Outcome|Tecnis MF|Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
331977|NCT01166971|O1|Outcome|ReSTOR +3|Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
331978|NCT01166971|E2|Reported Event|Tecnis MF|Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
331979|NCT01166971|E1|Reported Event|ReSTOR +3|Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
331980|NCT01166958|B3|Baseline|Total|Total of all reporting groups
331981|NCT01166958|B2|Baseline|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
331982|NCT01166958|B1|Baseline|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
331983|NCT01166958|P2|Participant Flow|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
331984|NCT01166958|P1|Participant Flow|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
331985|NCT01166958|O2|Outcome|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
331986|NCT01166958|O1|Outcome|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
331987|NCT01166958|O2|Outcome|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
332075|NCT01166347|O2|Outcome|Control LVAD|Control LVAD: Any FDA-approved LVAD for destination therapy.
331988|NCT01166958|O1|Outcome|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
331989|NCT01166958|O2|Outcome|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
331990|NCT01166958|O1|Outcome|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
331991|NCT01166958|O2|Outcome|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
331992|NCT01166958|O1|Outcome|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
331993|NCT01166958|O2|Outcome|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
331994|NCT01166958|O1|Outcome|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
331995|NCT01166958|E2|Reported Event|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
331996|NCT01166958|E1|Reported Event|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
331997|NCT01166763|B1|Baseline|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3~vitamin D3: oral capsules, 10,000 IU per week for 6 months"
331998|NCT01166763|P1|Participant Flow|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3~vitamin D3: oral capsules, 10,000 IU per week for 6 months"
331999|NCT01166763|O1|Outcome|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3~vitamin D3: oral capsules, 10,000 IU per week for 6 months"
332000|NCT01166763|O1|Outcome|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3~vitamin D3: oral capsules, 10,000 IU per week for 6 months"
332001|NCT01166763|O1|Outcome|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3~vitamin D3: oral capsules, 10,000 IU per week for 6 months"
332002|NCT01166763|E1|Reported Event|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3~vitamin D3: oral capsules, 10,000 IU per week for 6 months"
332003|NCT01166750|B3|Baseline|Total|Total of all reporting groups
332004|NCT01166750|B2|Baseline|Wait-list Control Group|Wait-list Control Group : Children in the control group will continue to follow recommendations and prescriptions by their treating rheumatologist. After an 8-week wait-list control condition that involves measurement phases identical to those of the Jointstrong Treatment Group but no Jointstrong treatment, the children in the control group will enter the Jointstrong program and will then have the same immediate post-treatment measures that the Treatment Group received. The Control Group will not, however, have the Treatment Group's 12-week follow-up phase.
332005|NCT01166750|B1|Baseline|CD-ROM-treatment|"CD-ROM : Treatment Group will continue to follow their treating rheumatologist's recommendations and prescriptions. The program will contain information on the multiple components of pain (the pain puzzle) as a treatment rationale and will then teach children to use cognitive-behavioral techniques for pain management. The information will be presented via visual displays, narration, and interactive menus. Children will be able to navigate through the different lessons at their own pace and will be required to take simple quizzes to assess their learning. Various passwords and homework assignments are embedded within the program to ensure that children are going through the material."
332006|NCT01166750|P2|Participant Flow|Wait-list Control Group|Wait-list Control Group : Children in the control group will continue to follow recommendations and prescriptions by their treating rheumatologist. After an 8-week wait-list control condition that involves measurement phases identical to those of the Jointstrong Treatment Group but no Jointstrong treatment, the children in the control group will enter the Jointstrong program and will then have the same immediate post-treatment measures that the Treatment Group received. The Control Group will not, however, have the Treatment Group's 12-week follow-up phase.
332007|NCT01166750|P1|Participant Flow|CD-ROM-treatment|"CD-ROM : Treatment Group will continue to follow their treating rheumatologist's recommendations and prescriptions. The program will contain information on the multiple components of pain (the pain puzzle) as a treatment rationale and will then teach children to use cognitive-behavioral techniques for pain management. The information will be presented via visual displays, narration, and interactive menus. Children will be able to navigate through the different lessons at their own pace and will be required to take simple quizzes to assess their learning. Various passwords and homework assignments are embedded within the program to ensure that children are going through the material."
332008|NCT01166750|O2|Outcome|Wait-List Control Group|
332009|NCT01166750|O1|Outcome|CD-ROM Treatment|Jointstrong
332076|NCT01166347|O1|Outcome|HeartWare® VAS|HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
332010|NCT01166750|E2|Reported Event|Wait-list Control Group|Wait-list Control Group : Children in the control group will continue to follow recommendations and prescriptions by their treating rheumatologist. After an 8-week wait-list control condition that involves measurement phases identical to those of the Jointstrong Treatment Group but no Jointstrong treatment, the children in the control group will enter the Jointstrong program and will then have the same immediate post-treatment measures that the Treatment Group received. The Control Group will not, however, have the Treatment Group's 12-week follow-up phase.
332011|NCT01166750|E1|Reported Event|CD-ROM-treatment|"CD-ROM : Treatment Group will continue to follow their treating rheumatologist's recommendations and prescriptions. The program will contain information on the multiple components of pain (the pain puzzle) as a treatment rationale and will then teach children to use cognitive-behavioral techniques for pain management. The information will be presented via visual displays, narration, and interactive menus. Children will be able to navigate through the different lessons at their own pace and will be required to take simple quizzes to assess their learning. Various passwords and homework assignments are embedded within the program to ensure that children are going through the material."
332012|NCT01166724|B3|Baseline|Total|Total of all reporting groups
332013|NCT01166724|B2|Baseline|Tacrolimus|Patient will stay on Tacrolimus
332014|NCT01166724|B1|Baseline|Sirolimus|"patients will be switched from Tacrolimus to Sirolimus~Sirolumus: Tacrolimus to Sirolimus~Tacrolimus: dosage per trough level"
332015|NCT01166724|P2|Participant Flow|Tacrolimus|Patient will stay on Tacrolimus
332016|NCT01166724|P1|Participant Flow|Sirolimus|"patients will be switched from Tacrolimus to Sirolimus~Sirolumus: Tacrolimus to Sirolimus~Tacrolimus: dosage per trough level"
332017|NCT01166724|O2|Outcome|Tacrolimus|Patient will stay on Tacrolimus
332018|NCT01166724|O1|Outcome|Sirolimus|"patients will be switched from Tacrolimus to Sirolimus~Sirolumus: Tacrolimus to Sirolimus~Tacrolimus: dosage per trough level"
332019|NCT01166724|O2|Outcome|Tacrolimus|Patient will stay on Tacrolimus
332020|NCT01166724|O1|Outcome|Sirolimus|"patients will be switched from Tacrolimus to Sirolimus~Sirolumus: Tacrolimus to Sirolimus~Tacrolimus: dosage per trough level"
332021|NCT01166724|E2|Reported Event|Tacrolimus|Patient will stay on Tacrolimus
332022|NCT01166724|E1|Reported Event|Sirolimus|"patients will be switched from Tacrolimus to Sirolimus~Sirolumus: Tacrolimus to Sirolimus~Tacrolimus: dosage per trough level"
332023|NCT01166659|B1|Baseline|CyPass Micro-Stent|Subjects received the CyPass Micro-Stent
332024|NCT01166659|P1|Participant Flow|CyPass Micro-Stent|Subjects received the CyPass Micro-Stent
332025|NCT01166659|O1|Outcome|CyPass Micro-Stent|Subjects received the CyPass Micro-Stent
332026|NCT01166659|O1|Outcome|CyPass Micro-Stent|Subjects received the CyPass Micro-Stent
332027|NCT01166659|O1|Outcome|CyPass Micro-Stent|Subjects received the CyPass Micro-Stent
332028|NCT01166659|E2|Reported Event|Ocular Adverse Events|At risk population for ocular adverse events is included with unit of eyes.
332029|NCT01166659|E1|Reported Event|Non-Ocular Adverse Events|At risk population for non-ocular adverse events is included with unit of subjects
332030|NCT01166646|B3|Baseline|Total|Total of all reporting groups
332031|NCT01166646|B2|Baseline|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
332032|NCT01166646|B1|Baseline|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
332033|NCT01166646|P2|Participant Flow|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
332034|NCT01166646|P1|Participant Flow|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
332035|NCT01166646|O2|Outcome|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
332036|NCT01166646|O1|Outcome|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
332037|NCT01166646|O2|Outcome|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
332038|NCT01166646|O1|Outcome|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
332039|NCT01166646|O2|Outcome|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
332040|NCT01166646|O1|Outcome|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
332041|NCT01166646|O2|Outcome|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
332042|NCT01166646|O1|Outcome|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
332043|NCT01166646|O2|Outcome|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
332044|NCT01166646|O1|Outcome|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
332045|NCT01166646|O2|Outcome|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
332046|NCT01166646|O1|Outcome|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
332047|NCT01166646|E2|Reported Event|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for 1-2 weeks"
332048|NCT01166646|E1|Reported Event|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for 1-2 weeks"
332049|NCT01166438|B3|Baseline|Total|Total of all reporting groups
343093|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
332050|NCT01166438|B2|Baseline|Standardized Anticholinergic Regimen|"A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.~Solifenacin 5mg: Oral Solifenacin 5mg once a day for up to 6 months~Solifenacin 10mg: Oral Solifenacin 10mg once a day for up to 4 mon"
332051|NCT01166438|B1|Baseline|Botox A|"A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets~Botulinum toxin A (Botox A®): A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices."
332052|NCT01166438|P2|Participant Flow|Standardized Anticholinergic Regimen|"A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.~Solifenacin 5mg: Oral Solifenacin 5mg once a day for up to 6 months~Solifenacin 10mg: Oral Solifenacin 10mg once a day for up to 4 mon"
332053|NCT01166438|P1|Participant Flow|Botox A|"A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets~Botulinum toxin A (Botox A®): A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices."
332054|NCT01166438|O2|Outcome|Standardized Anticholinergic Regimen|"A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.~Solifenacin 5mg: Oral Solifenacin 5mg once a day for up to 6 months~Solifenacin 10mg: Oral Solifenacin 10mg once a day for up to 4 months~Trospium chloride: Oral Trospium XR 60mg once a day for up to 2 months"
332055|NCT01166438|O1|Outcome|Botox A|"A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets~Botulinum toxin A (Botox A®): A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices."
332056|NCT01166438|O2|Outcome|Standardized Anticholinergic Regimen|"A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.~Solifenacin 5mg: Oral Solifenacin 5mg once a day for up to 6 months~Solifenacin 10mg: Oral Solifenacin 10mg once a day for up to 4 mon"
332057|NCT01166438|O1|Outcome|Botox A|"A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets~Botulinum toxin A (Botox A®): A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices."
332070|NCT01166347|P1|Participant Flow|HeartWare® Ventricular Assist System (VAS)|HeartWare® Ventricular Assist System(VAS): The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
332071|NCT01166347|O2|Outcome|Control LVAD|Control LVAD: Any FDA-approved LVAD for destination therapy.
332072|NCT01166347|O1|Outcome|HeartWare® VAS|HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
332073|NCT01166347|O2|Outcome|Control LVAD|Control LVAD: Any FDA-approved LVAD for destination therapy.
351118|NCT01119755|O1|Outcome|Group 1|
332058|NCT01166438|O2|Outcome|Standardized Anticholinergic Regimen|"A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.~Solifenacin 5mg: Oral Solifenacin 5mg once a day for up to 6 months~Solifenacin 10mg: Oral Solifenacin 10mg once a day for up to 4 mon"
332059|NCT01166438|O1|Outcome|Botox A|"A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets~Botulinum toxin A (Botox A®): A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices."
332060|NCT01166438|O2|Outcome|Standardized Anticholinergic Regimen|"A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.~Solifenacin 5mg: Oral Solifenacin 5mg once a day for up to 6 months~Solifenacin 10mg: Oral Solifenacin 10mg once a day for up to 4 mon"
332061|NCT01166438|O1|Outcome|Botox A|"A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets~Botulinum toxin A (Botox A®): A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices."
332062|NCT01166438|O2|Outcome|Standardized Anticholinergic Regimen|"A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.~Solifenacin 5mg: Oral Solifenacin 5mg once a day for up to 6 months~Solifenacin 10mg: Oral Solifenacin 10mg once a day for up to 4 mon"
332063|NCT01166438|O1|Outcome|Botox A|"A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets~Botulinum toxin A (Botox A®): A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices."
332064|NCT01166438|E2|Reported Event|Standardized Anticholinergic Regimen|A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. Dose escalation or drug change will be based exclusively on the result of the Patient Global Symptom Control Rating. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.
332065|NCT01166438|E1|Reported Event|Botox A|"A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets~Botulinum toxin A (Botox A®): A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices."
332066|NCT01166347|B3|Baseline|Total|Total of all reporting groups
332067|NCT01166347|B2|Baseline|Control LVAD|Control LVAD: Any FDA-approved LVAD for destination therapy.
332068|NCT01166347|B1|Baseline|HeartWare® VAS|HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
332069|NCT01166347|P2|Participant Flow|Control Left Ventricular Assist Device (LVAD)|Control Left Ventricular Assist Device (LVAD): Any Food and Drug Administration (FDA)-approved LVAD for destination therapy.
332074|NCT01166347|O1|Outcome|HeartWare® VAS|HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
332077|NCT01166347|O2|Outcome|Control LVAD|Control LVAD: Any FDA-approved LVAD for destination therapy.
332078|NCT01166347|O1|Outcome|HeartWare® VAS|HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
332079|NCT01166347|O2|Outcome|Control LVAD|Control LVAD: Any FDA-approved LVAD for destination therapy.
332080|NCT01166347|O1|Outcome|HeartWare® VAS|HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
332081|NCT01166347|O2|Outcome|Control LVAD|Control LVAD: Any FDA-approved LVAD for destination therapy.
332082|NCT01166347|O1|Outcome|HeartWare® VAS|HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
332083|NCT01166347|O2|Outcome|Control LVAD|Control LVAD: Any FDA-approved LVAD for destination therapy.
332084|NCT01166347|O1|Outcome|HeartWare® VAS|HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
332085|NCT01166347|O2|Outcome|Control LVAD|Control LVAD: Any FDA-approved LVAD for destination therapy.
332086|NCT01166347|O1|Outcome|HeartWare® VAS|HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
332087|NCT01166347|O2|Outcome|Control LVAD|Control LVAD: Any FDA-approved LVAD for destination therapy.
332088|NCT01166347|O1|Outcome|HeartWare® VAS|HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
332089|NCT01166347|O2|Outcome|Control LVAD|Control LVAD: Any FDA-approved LVAD for destination therapy.
332090|NCT01166347|O1|Outcome|HeartWare® VAS|HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
332091|NCT01166347|O2|Outcome|Control LVAD|Control LVAD: Any FDA-approved LVAD for destination therapy.
332092|NCT01166347|O1|Outcome|HeartWare® VAS|HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
332093|NCT01166347|O2|Outcome|Control LVAD|Control LVAD: Any FDA-approved LVAD for destination therapy.
332094|NCT01166347|O1|Outcome|HeartWare® VAS|HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
332095|NCT01166347|O2|Outcome|Control LVAD|Control LVAD: Any FDA-approved LVAD for destination therapy.
332096|NCT01166347|O1|Outcome|HeartWare® VAS|HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
332097|NCT01166347|E2|Reported Event|Control LVAD|Control LVAD: Any FDA-approved LVAD for destination therapy.
332098|NCT01166347|E1|Reported Event|HeartWare® VAS|HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
332099|NCT01166282|B3|Baseline|Total|Total of all reporting groups
332100|NCT01166282|B2|Baseline|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
332101|NCT01166282|B1|Baseline|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
332102|NCT01166282|P3|Participant Flow|Open-label Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for up to 192 weeks.
332103|NCT01166282|P2|Participant Flow|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
332104|NCT01166282|P1|Participant Flow|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
332105|NCT01166282|O3|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (double-blind or open-label) for up to 204 weeks.
332106|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
332107|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
332108|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
332109|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
332110|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
332111|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
332112|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
332113|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
332114|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
332115|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
332116|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
332117|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
332118|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
332119|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
332120|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
332121|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
332122|NCT01166282|E3|Reported Event|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (double-blind or open-label) for up to 204 weeks.
332123|NCT01166282|E2|Reported Event|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
332124|NCT01166282|E1|Reported Event|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
332125|NCT01166230|B3|Baseline|Total|Total of all reporting groups
332126|NCT01166230|B2|Baseline|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
332127|NCT01166230|B1|Baseline|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
332128|NCT01166230|P2|Participant Flow|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PCB305/04 who were followed for recurrence.
332129|NCT01166230|P1|Participant Flow|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PCB305/04 who were followed for recurrence.
332130|NCT01166230|O2|Outcome|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
332131|NCT01166230|O1|Outcome|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
332132|NCT01166230|O2|Outcome|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
332133|NCT01166230|O1|Outcome|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
332134|NCT01166230|O2|Outcome|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
332135|NCT01166230|O1|Outcome|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
332136|NCT01166230|O2|Outcome|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
332137|NCT01166230|O1|Outcome|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
332138|NCT01166230|E2|Reported Event|Patients With Ta/T1, Randomized to White Light Cystoscopy|
332139|NCT01166230|E1|Reported Event|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
332140|NCT01166178|B3|Baseline|Total|Total of all reporting groups
332141|NCT01166178|B2|Baseline|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
332142|NCT01166178|B1|Baseline|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
332143|NCT01166178|P2|Participant Flow|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
332144|NCT01166178|P1|Participant Flow|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
332145|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
332146|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
332147|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
332148|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
332149|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
332150|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
332151|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
332152|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
332153|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
332154|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
332155|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
332156|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
332157|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
332158|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
332159|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
332160|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
356837|NCT01104584|O3|Outcome|CMRM+XRM|
332161|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
332162|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
332163|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
332164|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
332165|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
332166|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
332167|NCT01166178|E2|Reported Event|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
332168|NCT01166178|E1|Reported Event|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
332169|NCT01166139|B1|Baseline|Nilotinib 400 mg Twice Daily|Nilotinib (Tasigna): Patients will be treated with Nilotinib 400 mg two times a day for 6 months and could continue treatment for at least 12 months.
332170|NCT01166139|P1|Participant Flow|Nilotinib 400 mg Twice Daily|Nilotinib (Tasigna): Patients will be treated with Nilotinib 400 mg two times a day for 6 months and could continue treatment for at least 12 months.
332171|NCT01166139|O1|Outcome|Nilotinib 400 mg Twice Daily|Nilotinib (Tasigna): Patients will be treated with Nilotinib 400 mg two times a day for 6 months and could continue treatment for at least 12 months.
332172|NCT01166139|O1|Outcome|Nilotinib 400 mg Twice Daily|Nilotinib (Tasigna): Patients will be treated with Nilotinib 400 mg two times a day for 6 months and could continue treatment for at least 12 months.
332173|NCT01166139|O1|Outcome|Nilotinib 400 mg Twice Daily|Nilotinib (Tasigna): Patients will be treated with Nilotinib 400 mg two times a day for 6 months and could continue treatment for at least 12 months.
332174|NCT01166139|E1|Reported Event|Nilotinib 400 mg Twice Daily|Nilotinib (Tasigna): Patients will be treated with Nilotinib 400 mg two times a day for 6 months and could continue treatment for at least 12 months.
332175|NCT01166126|B1|Baseline|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period begins with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).~Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.~The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
332176|NCT01166126|P1|Participant Flow|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period begins with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).~Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.~The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
332177|NCT01166126|O1|Outcome|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period began with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).~Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.~The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
332178|NCT01166126|O1|Outcome|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period began with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).~Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.~The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
332179|NCT01166126|O1|Outcome|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period began with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).~Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.~The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
332220|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
332221|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
332222|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
332180|NCT01166126|O1|Outcome|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period began with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).~Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.~The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
332181|NCT01166126|E1|Reported Event|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period begins with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).~Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.~The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
332182|NCT01165996|B1|Baseline|Arm I|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
332183|NCT01165996|P1|Participant Flow|Arm I|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
332184|NCT01165996|O1|Outcome|Arm I|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
332185|NCT01165996|O1|Outcome|Arm I|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
332186|NCT01165996|O1|Outcome|Arm I|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
332187|NCT01165996|E1|Reported Event|Arm I|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
332188|NCT01165983|B3|Baseline|Total|Total of all reporting groups
332189|NCT01165983|B2|Baseline|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
332190|NCT01165983|B1|Baseline|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
332191|NCT01165983|P2|Participant Flow|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
332192|NCT01165983|P1|Participant Flow|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
332193|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
332194|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
332195|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
332196|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
332197|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
332198|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
332199|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
332200|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
332201|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
332202|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
332203|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
332204|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
332205|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
332206|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
332207|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
332208|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
332209|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
332210|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
332211|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
332212|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
332213|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
332214|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
332215|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
332216|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
332217|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
332218|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
332219|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
404523|NCT00984308|O2|Outcome|Control|
332225|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
332226|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
332227|NCT01165983|O2|Outcome|T2DM Patients|
332228|NCT01165983|O1|Outcome|Subjects at Risk of DMII|
332229|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
332230|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
332231|NCT01165983|O2|Outcome|T2DM Patients|
332232|NCT01165983|O1|Outcome|Subjects at Risk of DMII|
332233|NCT01165983|E2|Reported Event|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
332234|NCT01165983|E1|Reported Event|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
332235|NCT01165840|B1|Baseline|Dapsone|"Dapsone 100 mg PO x 1 dose~Dapsone: 100 mg PO x 1 dose"
332236|NCT01165840|P1|Participant Flow|Dapsone|"Dapsone 100 mg PO x 1 dose~Dapsone: 100 mg PO x 1 dose"
332237|NCT01165840|O1|Outcome|Dapsone|"Dapsone 100 mg PO x 1 dose~Dapsone: 100 mg PO x 1 dose"
332238|NCT01165840|E1|Reported Event|Dapsone|"Dapsone 100 mg PO x 1 dose~Dapsone: 100 mg PO x 1 dose"
332239|NCT01165775|B1|Baseline|Threatened Pre Term Labor Patients|"Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.~Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter.~Data are available for 15 of 17 participants."
332240|NCT01165775|P1|Participant Flow|Threatened Pre Term Labor Patients|"Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.~Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter."
332241|NCT01165775|O3|Outcome|Neonates With Unknown Hypoglycemia Status|Neonates with unknown hypoglycemia status from birth to hospital discharge.
332242|NCT01165775|O2|Outcome|Neonates Without Hypoglycemia|Neonates without hypoglycemia from birth to hospital discharge.
332243|NCT01165775|O1|Outcome|Neonates With Hypoglycemia|Neonates with hypoglycemia from birth to hospital discharge.
332244|NCT01165775|O2|Outcome|Diabetic Threatened Pre Term Labor Patients|"Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.~Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter."
332245|NCT01165775|O1|Outcome|Non-Diabetic Threatened Pre Term Labor Patients|"Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.~Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter."
332246|NCT01165775|E1|Reported Event|Threatened Pre Term Labor Patients|"Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.~Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter."
332247|NCT01165684|B3|Baseline|Total|Total of all reporting groups
332248|NCT01165684|B2|Baseline|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
332249|NCT01165684|B1|Baseline|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
332250|NCT01165684|P2|Participant Flow|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
332251|NCT01165684|P1|Participant Flow|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
332252|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
332253|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
332254|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
332274|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
332255|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
332256|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
332257|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
332258|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
332259|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
332260|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
332261|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
332262|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
332263|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
332264|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
332265|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
332266|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
332267|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
332268|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
332269|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
332270|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
332271|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
332272|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
332273|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
333092|NCT01163955|E1|Reported Event|Sitting in a Chair 5 Minutes|Sitting in a chair with back support and feet flat on the ground
332275|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
332276|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
332277|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
332278|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
332279|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
332280|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
332281|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
332282|NCT01165684|E2|Reported Event|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
332283|NCT01165684|E1|Reported Event|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
332284|NCT01165554|B1|Baseline|Flutemetamol Injection|[18F]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of [18F]flutemetamol was 185 to 370 megabecquerels (MBq).
332285|NCT01165554|P1|Participant Flow|Flutemetamol Injection|[18F]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of [18F]flutemetamol was 185 to 370 megabecquerels (MBq).
332286|NCT01165554|O1|Outcome|Specificity-Normal Visual Reads|[18F]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of [18F]flutemetamol was 185 to 370 megabecquerels (MBq).
332287|NCT01165554|O1|Outcome|Sensitivity-Abnormal Visual Reads|[18F]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of [18F]flutemetamol was 185 to 370 megabecquerels (MBq).
332288|NCT01165554|O1|Outcome|Specificity Percentage of Normal Visual Reads|
332289|NCT01165554|O1|Outcome|Sensitivity Percentage of Abnormal Visual Reads|
332290|NCT01165554|E1|Reported Event|Flutemetamol Injection|[18F]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of [18F]flutemetamol was 185 to 370 megabecquerels (MBq).
332291|NCT01165541|B1|Baseline|Entire Study Population|Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d first for 7 weeks; then Quetiapine XR and mirtazapine: Quetiapine fumarate extended release (50-400mg) and mirtazapine (7.5-45mg) for 7 weeks.
332292|NCT01165541|P1|Participant Flow|Entire Study Population|Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d first for 7 weeks; then Quetiapine XR plus mirtazapine: Quetiapine fumarate extended release (50-400mg) plus mirtazapine (7.5-45mg) for 7 weeks.
332293|NCT01165541|O2|Outcome|Quetiapine XR Plus Mirtazapine|"Quetiapine XR 50-400mg + Mirtazapine 7.5-45mg~Quetiapine XR plus mirtazapine: Quetiapine fumarate extended release (50-400mg) plus mirtazapine (7.5-45mg)"
332294|NCT01165541|O1|Outcome|Quetiapine Fumarate Extended Release (Quetiapine XR)|"Quetiapine XR 50-400mg~Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d"
332295|NCT01165541|E2|Reported Event|Quetiapine XR andMirtazapine|"Quetiapine XR 50-400mg + Mirtazapine 7.5-45mg~Quetiapine XR and mirtazapine: Quetiapine fumarate extended release (50-400mg) and mirtazapine (7.5-45mg)"
332296|NCT01165541|E1|Reported Event|Quetiapine Fumarate Extended Release (Quetiapine XR)|"Quetiapine XR 50-400mg~Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d"
332297|NCT01165450|B1|Baseline|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
332298|NCT01165450|P1|Participant Flow|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
332388|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332299|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
332300|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
332301|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
332302|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
332303|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
332304|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
332305|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
332306|NCT01165450|E1|Reported Event|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
332307|NCT01165424|B1|Baseline|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg device.~Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.~Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks."
332308|NCT01165424|P1|Participant Flow|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg device.~Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.~Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks."
332309|NCT01165424|O1|Outcome|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg device.~Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.~Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks."
332310|NCT01165424|O1|Outcome|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg device.~Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.~Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks."
332311|NCT01165424|E1|Reported Event|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg device.~Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.~Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks."
332312|NCT01165320|B3|Baseline|Total|Total of all reporting groups
332313|NCT01165320|B2|Baseline|Participants With Aspergillosis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.
332314|NCT01165320|B1|Baseline|Participants With Invasive Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively.
332315|NCT01165320|P3|Participant Flow|Participants With Esophageal Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 7 and 28 days, respectively.
332316|NCT01165320|P2|Participant Flow|Participants With Aspergillosis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.
332317|NCT01165320|P1|Participant Flow|Participants With Invasive Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively.
332318|NCT01165320|O2|Outcome|Participants With Aspergillosis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively
332319|NCT01165320|O1|Outcome|Participants With Invasive Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively
332320|NCT01165320|O2|Outcome|Participants With Aspergillosis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively
332321|NCT01165320|O1|Outcome|Participants With Invasive Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively
332322|NCT01165320|E2|Reported Event|Participants With Aspergillosis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.
332323|NCT01165320|E1|Reported Event|Participants With Invasive Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively.
332324|NCT01165307|B3|Baseline|Total|Total of all reporting groups
332325|NCT01165307|B2|Baseline|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
332326|NCT01165307|B1|Baseline|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
332327|NCT01165307|P2|Participant Flow|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
332328|NCT01165307|P1|Participant Flow|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
332329|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
332330|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
332331|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
332332|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
332333|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
332334|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
332335|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
332336|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
332337|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
332424|NCT01165229|O2|Outcome|Zoster-022/006 Pooled Placebo Group|Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332338|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
332339|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
332340|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
332341|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
332342|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
332343|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
332344|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
332345|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
332346|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
332347|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
332348|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
332349|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
332350|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
332351|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
332352|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
332389|NCT01165242|O3|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332426|NCT01165229|O2|Outcome|Zoster-022/006 Pooled Placebo Group|Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332353|NCT01165307|E2|Reported Event|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
332354|NCT01165307|E1|Reported Event|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
332355|NCT01165281|B3|Baseline|Total|Total of all reporting groups
332356|NCT01165281|B2|Baseline|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
332357|NCT01165281|B1|Baseline|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
332358|NCT01165281|P2|Participant Flow|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
332359|NCT01165281|P1|Participant Flow|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
332360|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
332361|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
332362|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
332390|NCT01165242|O2|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332363|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
332364|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
332365|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
332366|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
332367|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
332368|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
332369|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
332370|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
332391|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332425|NCT01165229|O1|Outcome|Zoster-022/006 Pooled GSK1437173A Group|Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332371|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
332372|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
332373|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
332374|NCT01165281|E2|Reported Event|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
332375|NCT01165281|E1|Reported Event|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
332376|NCT01165242|B4|Baseline|Total|Total of all reporting groups
332377|NCT01165242|B3|Baseline|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332378|NCT01165242|B2|Baseline|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332379|NCT01165242|B1|Baseline|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332380|NCT01165242|P3|Participant Flow|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332381|NCT01165242|P2|Participant Flow|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332382|NCT01165242|P1|Participant Flow|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332383|NCT01165242|O3|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332384|NCT01165242|O2|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332385|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332386|NCT01165242|O3|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332387|NCT01165242|O2|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
333093|NCT01163916|B4|Baseline|Total|Total of all reporting groups
332392|NCT01165242|O3|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332393|NCT01165242|O2|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332394|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332395|NCT01165242|O3|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332396|NCT01165242|O2|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332397|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332398|NCT01165242|O1|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332399|NCT01165242|O3|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332400|NCT01165242|O2|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332401|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332402|NCT01165242|O3|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332403|NCT01165242|O2|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332404|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332405|NCT01165242|O3|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332406|NCT01165242|O2|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332407|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332408|NCT01165242|O2|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332409|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332410|NCT01165242|E3|Reported Event|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332411|NCT01165242|E2|Reported Event|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332412|NCT01165242|E1|Reported Event|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
332413|NCT01165229|B3|Baseline|Total|Total of all reporting groups
332414|NCT01165229|B2|Baseline|Zoster-022 Placebo Group|Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332415|NCT01165229|B1|Baseline|Zoster-022 GSK1437173A Group|Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332416|NCT01165229|P2|Participant Flow|Zoster-022 Placebo Group|Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332417|NCT01165229|P1|Participant Flow|Zoster-022 GSK1437173A Group|Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332418|NCT01165229|O2|Outcome|Zoster-022/006 Pooled Placebo Group|Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332419|NCT01165229|O1|Outcome|Zoster-022/006 Pooled GSK1437173A Group|Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332420|NCT01165229|O2|Outcome|Zoster-022/006 Pooled Placebo Group|Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332421|NCT01165229|O1|Outcome|Zoster-022/006 Pooled GSK1437173A Group|Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332422|NCT01165229|O2|Outcome|Zoster-022/006 Pooled Placebo Group|Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332423|NCT01165229|O1|Outcome|Zoster-022/006 Pooled GSK1437173A Group|Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332427|NCT01165229|O1|Outcome|Zoster-022/006 Pooled GSK1437173A Group|Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332428|NCT01165229|O2|Outcome|Zoster-022/006 Pooled Placebo Group|Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332429|NCT01165229|O1|Outcome|Zoster-022/006 Pooled GSK1437173A Group|Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332430|NCT01165229|O6|Outcome|Zoster-022/006 Pooled Placebo >=70 YOA Group|Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332431|NCT01165229|O5|Outcome|Zoster-022/006 Pooled Placebo >=80 YOA Group|Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332432|NCT01165229|O4|Outcome|Zoster-022/006 Pooled Placebo 70-79 YOA Group|Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332433|NCT01165229|O3|Outcome|Zoster-022/006 Pooled GSK1437173A >=70 YOA Group|Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332434|NCT01165229|O2|Outcome|Zoster-022/006 Pooled GSK1437173A >=80 YOA Group|Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332435|NCT01165229|O1|Outcome|Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group|Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332436|NCT01165229|O6|Outcome|Zoster-022/006 Pooled Placebo >=70 YOA Group|Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332437|NCT01165229|O5|Outcome|Zoster-022/006 Pooled Placebo >=80 YOA Group|Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332438|NCT01165229|O4|Outcome|Zoster-022/006 Pooled Placebo 70-79 YOA Group|Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332439|NCT01165229|O3|Outcome|Zoster-022/006 Pooled GSK1437173A >=70 YOA Group|Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332440|NCT01165229|O2|Outcome|Zoster-022/006 Pooled GSK1437173A >=80 YOA Group|Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332441|NCT01165229|O1|Outcome|Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group|Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332442|NCT01165229|O10|Outcome|Zoster-022/006 Pooled Placebo >=50 YOA Group|Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332443|NCT01165229|O9|Outcome|Zoster-022/006 Pooled Placebo >=80 YOA Group|Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332444|NCT01165229|O8|Outcome|Zoster-022/006 Pooled Placebo 70-79 YOA Group|Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332445|NCT01165229|O7|Outcome|Zoster-022/006 Pooled Placebo 60-69 YOA Group|Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332446|NCT01165229|O6|Outcome|Zoster-022/006 Pooled Placebo 50-59 YOA Group|Subjects between 50 and 59 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332447|NCT01165229|O5|Outcome|Zoster-022/006 Pooled GSK1437173A >=50 YOA Group|Subjects above 50 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332448|NCT01165229|O4|Outcome|Zoster-022/006 Pooled GSK1437173A >=80 YOA Group|Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332449|NCT01165229|O3|Outcome|Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group|Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332450|NCT01165229|O2|Outcome|Zoster-022/006 Pooled GSK1437173A 60-69 YOA Group|Subjects between 60 and 69 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332451|NCT01165229|O1|Outcome|Zoster-022/006 Pooled GSK1437173A 50-59 YOA Group|Subjects between 50 and 59 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332452|NCT01165229|O10|Outcome|Zoster-022/006 Pooled Placebo >=50 YOA Group|Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332453|NCT01165229|O9|Outcome|Zoster-022/006 Pooled Placebo >=80 YOA Group|Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332454|NCT01165229|O8|Outcome|Zoster-022/006 Pooled Placebo 70-79 YOA Group|Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332455|NCT01165229|O7|Outcome|Zoster-022/006 Pooled Placebo 60-69 YOA Group|Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332456|NCT01165229|O6|Outcome|Zoster-022/006 Pooled Placebo 50-59 YOA Group|Subjects between 50 and 59 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332457|NCT01165229|O5|Outcome|Zoster-022/006 Pooled GSK1437173A >=50 YOA Group|Subjects above 50 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332458|NCT01165229|O4|Outcome|Zoster-022/006 Pooled GSK1437173A >=80 YOA Group|Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332459|NCT01165229|O3|Outcome|Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group|Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332460|NCT01165229|O2|Outcome|Zoster-022/006 Pooled GSK1437173A 60-69 YOA Group|Subjects between 60 and 69 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332461|NCT01165229|O1|Outcome|Zoster-022/006 Pooled GSK1437173A 50-59 YOA Group|Subjects between 50 and 59 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332462|NCT01165229|O2|Outcome|Zoster-022 Placebo Group|Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332463|NCT01165229|O1|Outcome|Zoster-022 GSK1437173A Group|Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332464|NCT01165229|O2|Outcome|Zoster-022 Placebo Group|Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332465|NCT01165229|O1|Outcome|Zoster-022 GSK1437173A Group|Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332466|NCT01165229|O2|Outcome|Zoster-022 Placebo Group|Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332467|NCT01165229|O1|Outcome|Zoster-022 GSK1437173A Group|Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332468|NCT01165229|O2|Outcome|Zoster-022 Placebo Group|Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332469|NCT01165229|O1|Outcome|Zoster-022 GSK1437173A Group|Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332470|NCT01165229|O2|Outcome|Zoster-022 Placebo Group|Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332471|NCT01165229|O1|Outcome|Zoster-022 GSK1437173A Group|Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332472|NCT01165229|O2|Outcome|Zoster-022 Placebo Group|Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332473|NCT01165229|O1|Outcome|Zoster-022 GSK1437173A Group|Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332474|NCT01165229|O6|Outcome|Zoster-022 Placebo >=70YOA Group|Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332475|NCT01165229|O5|Outcome|Zoster-022 Placebo >=80YOA Group|Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332476|NCT01165229|O4|Outcome|Zoster-022 Placebo 70-79YOA Group|Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332477|NCT01165229|O3|Outcome|Zoster-022 GSK1437173A >=70YOA Group|Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332478|NCT01165229|O2|Outcome|Zoster-022 GSK1437173A >=80YOA Group|Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332479|NCT01165229|O1|Outcome|Zoster-022 GSK1437173A 70-79YOA Group|Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332480|NCT01165229|O6|Outcome|Zoster-022 Placebo >=70YOA Group|Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332481|NCT01165229|O5|Outcome|Zoster-022 Placebo >=80YOA Group|Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332482|NCT01165229|O4|Outcome|Zoster-022 Placebo 70-79YOA Group|Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332483|NCT01165229|O3|Outcome|Zoster-022 GSK1437173A >=70YOA Group|Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332484|NCT01165229|O2|Outcome|Zoster-022 GSK1437173A >=80YOA Group|Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332485|NCT01165229|O1|Outcome|Zoster-022 GSK1437173A 70-79YOA Group|Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332486|NCT01165229|O6|Outcome|Zoster-022 Placebo >=70YOA Group|Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332487|NCT01165229|O5|Outcome|Zoster-022 Placebo >=80YOA Group|Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332488|NCT01165229|O4|Outcome|Zoster-022 Placebo 70-79YOA Group|Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332489|NCT01165229|O3|Outcome|Zoster-022 GSK1437173A >=70YOA Group|Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332490|NCT01165229|O2|Outcome|Zoster-022 GSK1437173A >=80YOA Group|Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332491|NCT01165229|O1|Outcome|Zoster-022 GSK1437173A 70-79YOA Group|Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332492|NCT01165229|O6|Outcome|Zoster-022 Placebo >=70YOA Group|Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332493|NCT01165229|O5|Outcome|Zoster-022 Placebo >=80YOA Group|Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332494|NCT01165229|O4|Outcome|Zoster-022 Placebo 70-79YOA Group|Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332495|NCT01165229|O3|Outcome|Zoster-022 GSK1437173A >=70YOA Group|Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332496|NCT01165229|O2|Outcome|Zoster-022 GSK1437173A >=80YOA Group|Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332497|NCT01165229|O1|Outcome|Zoster-022 GSK1437173A 70-79YOA Group|Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332675|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332498|NCT01165229|O6|Outcome|Zoster-022 Placebo >=70YOA Group|Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332499|NCT01165229|O5|Outcome|Zoster-022 Placebo >=80YOA Group|Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332500|NCT01165229|O4|Outcome|Zoster-022 Placebo 70-79YOA Group|Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332501|NCT01165229|O3|Outcome|Zoster-022 GSK1437173A >=70YOA Group|Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332502|NCT01165229|O2|Outcome|Zoster-022 GSK1437173A >=80YOA Group|Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332503|NCT01165229|O1|Outcome|Zoster-022 GSK1437173A 70-79YOA Group|Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332504|NCT01165229|O6|Outcome|Zoster-022 Placebo >=70YOA Group|Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332505|NCT01165229|O5|Outcome|Zoster-022 Placebo >=80YOA Group|Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332506|NCT01165229|O4|Outcome|Zoster-022 Placebo 70-79YOA Group|Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332507|NCT01165229|O3|Outcome|Zoster-022 GSK1437173A >=70YOA Group|Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332508|NCT01165229|O2|Outcome|Zoster-022 GSK1437173A >=80YOA Group|Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332509|NCT01165229|O1|Outcome|Zoster-022 GSK1437173A 70-79YOA Group|Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332510|NCT01165229|O6|Outcome|Zoster-022 Placebo >=70YOA Group|Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332511|NCT01165229|O5|Outcome|Zoster-022 Placebo >=80YOA Group|Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332512|NCT01165229|O4|Outcome|Zoster-022 Placebo 70-79YOA Group|Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332513|NCT01165229|O3|Outcome|Zoster-022 GSK1437173A >=70YOA Group|Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332514|NCT01165229|O2|Outcome|Zoster-022 GSK1437173A >=80YOA Group|Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332515|NCT01165229|O1|Outcome|Zoster-022 GSK1437173A 70-79YOA Group|Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332516|NCT01165229|O6|Outcome|Zoster-022 Placebo >=70YOA Group|Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332517|NCT01165229|O5|Outcome|Zoster-022 Placebo >=80YOA Group|Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332518|NCT01165229|O4|Outcome|Zoster-022 Placebo 70-79YOA Group|Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332519|NCT01165229|O3|Outcome|Zoster-022 GSK1437173A >=70YOA Group|Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332520|NCT01165229|O2|Outcome|Zoster-022 GSK1437173A >=80YOA Group|Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332521|NCT01165229|O1|Outcome|Zoster-022 GSK1437173A 70-79YOA Group|Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332522|NCT01165229|O6|Outcome|Zoster-022/006 Pooled Placebo >=70YOA Group|Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332523|NCT01165229|O5|Outcome|Zoster-022/006 Pooled Placebo >=80YOA Group|Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332524|NCT01165229|O4|Outcome|Zoster-022/006 Pooled Placebo 70-79YOA Group|Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332525|NCT01165229|O3|Outcome|Zoster-022/006 Pooled GSK1437173A >=70YOA Group|Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332526|NCT01165229|O2|Outcome|Zoster-022/006 Pooled GSK1437173A >=80YOA Group|Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332527|NCT01165229|O1|Outcome|Zoster-022/006 Pooled GSK1437173A 70-79YOA Group|Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332528|NCT01165229|O6|Outcome|Zoster-022/006 Pooled Placebo >=70YOA Group|Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332529|NCT01165229|O5|Outcome|Zoster-022/006 Pooled Placebo >=80YOA Group|Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332530|NCT01165229|O4|Outcome|Zoster-022/006 Pooled Placebo 70-79YOA Group|Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332531|NCT01165229|O3|Outcome|Zoster-022/006 Pooled GSK1437173A >=70YOA Group|Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332532|NCT01165229|O2|Outcome|Zoster-022/006 Pooled GSK1437173A >=80YOA Group|Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332533|NCT01165229|O1|Outcome|Zoster-022/006 Pooled GSK1437173A 70-79YOA Group|Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332534|NCT01165229|O6|Outcome|Zoster-022 Placebo >=70YOA Group|Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332535|NCT01165229|O5|Outcome|Zoster-022 Placebo >=80YOA Group|Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332536|NCT01165229|O4|Outcome|Zoster-022 Placebo 70-79YOA Group|Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332537|NCT01165229|O3|Outcome|Zoster-022 GSK1437173A >=70YOA Group|Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332538|NCT01165229|O2|Outcome|Zoster-022 GSK1437173A >=80YOA Group|Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332539|NCT01165229|O1|Outcome|Zoster-022 GSK1437173A 70-79YOA Group|Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332540|NCT01165229|E2|Reported Event|Zoster-022 Placebo Group|Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332541|NCT01165229|E1|Reported Event|Zoster-022 GSK1437173A Group|Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
332542|NCT01165216|B3|Baseline|Total|Total of all reporting groups
332543|NCT01165216|B2|Baseline|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
332544|NCT01165216|B1|Baseline|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
332545|NCT01165216|P2|Participant Flow|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
332546|NCT01165216|P1|Participant Flow|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2 , administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
332547|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2 , administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses) and carboplatin, AUC=6, administered as a single dose IV over 30 -60 minutes every 3 weeks (up to 6 doses).
332548|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
332549|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
332550|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
332551|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
332552|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
332553|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
332554|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
332577|NCT01165203|O5|Outcome|Non-ART High CD4 Cohort - GSK 1437173A|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332555|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
332556|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
332557|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses) and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
332558|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
332559|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
332560|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
332561|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses) and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
332562|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
332563|NCT01165216|E2|Reported Event|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
332564|NCT01165216|E1|Reported Event|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
332565|NCT01165203|B3|Baseline|Total|Total of all reporting groups
332566|NCT01165203|B2|Baseline|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332567|NCT01165203|B1|Baseline|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332568|NCT01165203|P2|Participant Flow|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332569|NCT01165203|P1|Participant Flow|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332570|NCT01165203|O6|Outcome|Non-ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332571|NCT01165203|O5|Outcome|Non-ART High CD4 Cohort - GSK 1437173A|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332572|NCT01165203|O4|Outcome|ART Low CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332573|NCT01165203|O3|Outcome|ART Low CD4 Cohort - GSK 1437173A|ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332574|NCT01165203|O2|Outcome|ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332575|NCT01165203|O1|Outcome|Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A|ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332576|NCT01165203|O6|Outcome|Non-ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332674|NCT01165177|O1|Outcome|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
332578|NCT01165203|O4|Outcome|ART Low CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332579|NCT01165203|O3|Outcome|ART Low CD4 Cohort - GSK 1437173A|ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332580|NCT01165203|O2|Outcome|ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332581|NCT01165203|O1|Outcome|Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A|ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332582|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332583|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332584|NCT01165203|O6|Outcome|Non-ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332585|NCT01165203|O5|Outcome|Non-ART High CD4 Cohort - GSK 1437173A|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332586|NCT01165203|O4|Outcome|ART Low CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332587|NCT01165203|O3|Outcome|ART Low CD4 Cohort - GSK 1437173A|ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332588|NCT01165203|O2|Outcome|ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332589|NCT01165203|O1|Outcome|Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A|ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332590|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332591|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332592|NCT01165203|O6|Outcome|Non-ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332593|NCT01165203|O5|Outcome|Non-ART High CD4 Cohort - GSK 1437173A|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332594|NCT01165203|O4|Outcome|ART Low CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332595|NCT01165203|O3|Outcome|ART Low CD4 Cohort - GSK 1437173A|ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332596|NCT01165203|O2|Outcome|ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332597|NCT01165203|O1|Outcome|Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A|ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332598|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332599|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332600|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332601|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332602|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332603|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332604|NCT01165203|O6|Outcome|Non-ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332605|NCT01165203|O5|Outcome|Non-ART High CD4 Cohort - GSK 1437173A|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
334124|NCT01161446|P2|Participant Flow|Standard Testing|HIV testing as usual.
332606|NCT01165203|O4|Outcome|ART Low CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332607|NCT01165203|O3|Outcome|ART Low CD4 Cohort - GSK 1437173A|ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332608|NCT01165203|O2|Outcome|ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332609|NCT01165203|O1|Outcome|Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A|ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332610|NCT01165203|O6|Outcome|Non-ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332611|NCT01165203|O5|Outcome|Non-ART High CD4 Cohort - GSK 1437173A|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332612|NCT01165203|O4|Outcome|ART Low CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332613|NCT01165203|O3|Outcome|ART Low CD4 Cohort - GSK 1437173A|ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332614|NCT01165203|O2|Outcome|ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332615|NCT01165203|O1|Outcome|Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A|ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332616|NCT01165203|O6|Outcome|Non-ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332617|NCT01165203|O5|Outcome|Non-ART High CD4 Cohort - GSK 1437173A|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332618|NCT01165203|O4|Outcome|ART Low CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332619|NCT01165203|O3|Outcome|ART Low CD4 Cohort - GSK 1437173A|ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332620|NCT01165203|O2|Outcome|ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332621|NCT01165203|O1|Outcome|Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A|ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332622|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332623|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332624|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332625|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332626|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332627|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332628|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332629|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332630|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332631|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332632|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332633|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332634|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
343094|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
332635|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332636|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332637|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332638|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332639|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332640|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332641|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332642|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332643|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332644|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332645|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332646|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332647|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332648|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332649|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332650|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332651|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332652|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332653|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332654|NCT01165203|E2|Reported Event|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332655|NCT01165203|E1|Reported Event|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
332656|NCT01165177|B3|Baseline|Total|Total of all reporting groups
332657|NCT01165177|B2|Baseline|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332658|NCT01165177|B1|Baseline|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
332659|NCT01165177|P2|Participant Flow|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332660|NCT01165177|P1|Participant Flow|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
332661|NCT01165177|O2|Outcome|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332662|NCT01165177|O1|Outcome|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
332663|NCT01165177|O2|Outcome|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332664|NCT01165177|O1|Outcome|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
332665|NCT01165177|O2|Outcome|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332666|NCT01165177|O1|Outcome|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
332667|NCT01165177|O2|Outcome|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332668|NCT01165177|O1|Outcome|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
332669|NCT01165177|O2|Outcome|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332670|NCT01165177|O1|Outcome|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
332671|NCT01165177|O2|Outcome|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332672|NCT01165177|O1|Outcome|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
332673|NCT01165177|O2|Outcome|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
334969|NCT01158976|O2|Outcome|Soybean Oil|Placebo: soybean oils with strawberry flavoring
332676|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332677|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332678|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332679|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332680|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332681|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332682|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332683|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332684|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332685|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332686|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332687|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332688|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332689|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332690|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332691|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332692|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332693|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332694|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332695|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332696|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332697|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332698|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332699|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332700|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332701|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332702|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332703|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332704|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332705|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332706|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332707|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332708|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332709|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332710|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332711|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332712|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332713|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332714|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332715|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332716|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
335659|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
332717|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332718|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332719|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332720|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332721|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332722|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332723|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332724|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332725|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332726|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332727|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332728|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332729|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332730|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332731|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332732|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332733|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332734|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332735|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332736|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332737|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332738|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332739|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332740|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332741|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332742|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332743|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332744|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332745|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332746|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332747|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332748|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332749|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332750|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332751|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332752|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332753|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332754|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332755|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332756|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332757|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
335660|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
332758|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332759|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332760|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332761|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332762|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332763|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332764|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332765|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332766|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332767|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332768|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332769|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332770|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332771|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332772|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332773|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332774|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
332775|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332776|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332777|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332778|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
332779|NCT01165177|E2|Reported Event|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
332780|NCT01165177|E1|Reported Event|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
332781|NCT01165138|B4|Baseline|Total|Total of all reporting groups
332782|NCT01165138|B3|Baseline|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332783|NCT01165138|B2|Baseline|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332784|NCT01165138|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332785|NCT01165138|P4|Participant Flow|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332786|NCT01165138|P3|Participant Flow|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332787|NCT01165138|P2|Participant Flow|Placebo|Participants (par.) received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332788|NCT01165138|P1|Participant Flow|Current Anti-asthma Therapy at a Fixed Dose|Participants were instructed to continue using an approved fixed dose of an inhaled corticosteroid (ICS) for 4 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Run-in Period.
332789|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332790|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332791|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
333010|NCT01164501|P3|Participant Flow|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
332792|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332793|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332794|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332795|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332796|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332797|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332798|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332799|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332800|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332801|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332802|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332803|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332804|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332805|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332806|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332807|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332808|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332809|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332810|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332811|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332812|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332813|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332814|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332815|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332816|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332817|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332818|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332819|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332820|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332821|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332822|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332823|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332824|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332825|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332826|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332827|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332828|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332829|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332830|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332831|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332832|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332833|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332834|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332835|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332836|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332837|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332838|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332839|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332840|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332841|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332842|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332843|NCT01165138|E3|Reported Event|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332844|NCT01165138|E2|Reported Event|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332845|NCT01165138|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
332846|NCT01165112|B1|Baseline|Treatment (Chemotherapy and Monoclonal Antibody Therapy)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Carboplatin: Given IV~Rituximab: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
332847|NCT01165112|P1|Participant Flow|Treatment (Chemotherapy and Monoclonal Antibody Therapy)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Carboplatin: Given IV~Rituximab: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
332848|NCT01165112|O1|Outcome|Treatment (Chemotherapy and Monoclonal Antibody Therapy)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Carboplatin: Given IV~Rituximab: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
332849|NCT01165112|O1|Outcome|Treatment (Chemotherapy and Monoclonal Antibody Therapy)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Carboplatin: Given IV~Rituximab: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
332850|NCT01165112|O1|Outcome|Treatment (Chemotherapy and Monoclonal Antibody Therapy)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Carboplatin: Given IV~Rituximab: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
332851|NCT01165112|O1|Outcome|Treatment (Chemotherapy and Monoclonal Antibody Therapy)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Carboplatin: Given IV~Rituximab: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
332852|NCT01165112|E1|Reported Event|Treatment (Chemotherapy and Monoclonal Antibody Therapy)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Carboplatin: Given IV~Rituximab: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
332853|NCT01165047|B1|Baseline|Nitric Oxide|"80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM~Nitric Oxide: Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM."
332854|NCT01165047|P1|Participant Flow|Nitric Oxide|"80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM~Nitric Oxide: Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM."
332855|NCT01165047|O1|Outcome|Nitric Oxide|"80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM~Nitric Oxide: Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM."
332856|NCT01165047|E1|Reported Event|Nitric Oxide|"80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM~Nitric Oxide: Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM."
332857|NCT01165021|B1|Baseline|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
332858|NCT01165021|P1|Participant Flow|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
333094|NCT01163916|B3|Baseline|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
332859|NCT01165021|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
332860|NCT01165021|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
332861|NCT01165021|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
332862|NCT01165021|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
332863|NCT01165021|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
332864|NCT01165021|E1|Reported Event|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
332865|NCT01164891|B1|Baseline|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
332866|NCT01164891|P1|Participant Flow|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 milligrams (mg) orally two times daily (BID) from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
332867|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
332868|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
332869|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
332870|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15 participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
332871|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
332872|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
332873|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
332874|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
332875|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
332876|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
332877|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
332878|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
332879|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
332880|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
332881|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
332882|NCT01164891|E1|Reported Event|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
332883|NCT01164865|B3|Baseline|Total|Total of all reporting groups
332884|NCT01164865|B2|Baseline|Clear Care|Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
332885|NCT01164865|B1|Baseline|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
332886|NCT01164865|P2|Participant Flow|Clear Care|Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
332887|NCT01164865|P1|Participant Flow|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
332888|NCT01164865|O2|Outcome|Clear Care|Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
332889|NCT01164865|O1|Outcome|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
332890|NCT01164865|O2|Outcome|Clear Care|Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
332891|NCT01164865|O1|Outcome|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
332892|NCT01164865|E2|Reported Event|Clear Care|Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
332893|NCT01164865|E1|Reported Event|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
332894|NCT01164722|B3|Baseline|Total|Total of all reporting groups
332895|NCT01164722|B2|Baseline|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
332896|NCT01164722|B1|Baseline|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
332897|NCT01164722|P2|Participant Flow|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
343095|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
332898|NCT01164722|P1|Participant Flow|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
332899|NCT01164722|O2|Outcome|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
332900|NCT01164722|O1|Outcome|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
332901|NCT01164722|O2|Outcome|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
332902|NCT01164722|O1|Outcome|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
332903|NCT01164722|O2|Outcome|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
332904|NCT01164722|O1|Outcome|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
332905|NCT01164722|O2|Outcome|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
332906|NCT01164722|O1|Outcome|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
332907|NCT01164722|O2|Outcome|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
332908|NCT01164722|O1|Outcome|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
332909|NCT01164722|E2|Reported Event|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
332910|NCT01164722|E1|Reported Event|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
332911|NCT01164644|B3|Baseline|Total|Total of all reporting groups
332912|NCT01164644|B2|Baseline|Placebo|The subject will take twelve pills by mouth three times a day over four days.
332913|NCT01164644|B1|Baseline|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
332914|NCT01164644|P2|Participant Flow|Placebo|The subject will take twelve pills by mouth three times a day over four days.
332915|NCT01164644|P1|Participant Flow|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
332916|NCT01164644|O2|Outcome|Placebo|The subject will take twelve pills by mouth three times a day over four days.
332917|NCT01164644|O1|Outcome|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
332918|NCT01164644|O2|Outcome|Placebo|The subject will take twelve pills by mouth three times a day over four days.
332919|NCT01164644|O1|Outcome|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
332920|NCT01164644|O2|Outcome|Placebo|The subject will take twelve pills by mouth three times a day over four days.
332921|NCT01164644|O1|Outcome|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
332922|NCT01164644|E2|Reported Event|Placebo|The subject will take twelve pills by mouth three times a day over four days.
332923|NCT01164644|E1|Reported Event|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
332924|NCT01164579|B4|Baseline|Total|Total of all reporting groups
332925|NCT01164579|B3|Baseline|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
333263|NCT01163721|E1|Reported Event|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
332926|NCT01164579|B2|Baseline|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332927|NCT01164579|B1|Baseline|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332928|NCT01164579|P3|Participant Flow|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332929|NCT01164579|P2|Participant Flow|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332930|NCT01164579|P1|Participant Flow|Tofacitinib (CP-690,550) Plus Methotrexate (MTX)|Participants received CP-690,550 10 milligrams (mg), tablets, orally (PO), twice daily (BID), and MTX 10 mg per week (mg/week) to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332931|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332932|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332933|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332934|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332935|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
333011|NCT01164501|P2|Participant Flow|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.
333012|NCT01164501|P1|Participant Flow|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
333264|NCT01163656|B3|Baseline|Total|Total of all reporting groups
332936|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332937|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332938|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332939|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332940|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332941|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332942|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332943|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332944|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332945|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
333013|NCT01164501|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
333014|NCT01164501|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.
333015|NCT01164501|O1|Outcome|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
343096|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
332946|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332947|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332948|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332949|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332950|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332951|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 milligrams (mg), tablets, orally (PO), twice daily (BID), and MTX 10 mg per week (mg/week) to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332952|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332953|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332954|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332955|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
333016|NCT01164501|O2|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
333017|NCT01164501|O1|Outcome|Placebo|Placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
333018|NCT01164501|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
343097|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
332956|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332957|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 milligrams (mg), tablets, orally (PO), twice daily (BID), and MTX 10 mg per week (mg/week) to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332958|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332959|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332960|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332961|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332962|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332963|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332964|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332965|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
333019|NCT01164501|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.
333020|NCT01164501|O1|Outcome|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
333021|NCT01164501|O2|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
332966|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332967|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332968|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332969|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332970|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332971|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332972|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332973|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332974|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332975|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
333022|NCT01164501|O1|Outcome|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
333023|NCT01164501|E3|Reported Event|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
333024|NCT01164501|E2|Reported Event|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.
343098|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
332976|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332977|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332978|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332979|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332980|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332981|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332982|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332983|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332984|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332985|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
333025|NCT01164501|E1|Reported Event|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
333026|NCT01164475|B3|Baseline|Total|Total of all reporting groups
333095|NCT01163916|B2|Baseline|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
333096|NCT01163916|B1|Baseline|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
343099|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
332986|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332987|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332988|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332989|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332990|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332991|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332992|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332993|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332994|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332995|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
333067|NCT01164137|O1|Outcome|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
333068|NCT01164137|E2|Reported Event|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
332996|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332997|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332998|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
332999|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
333000|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
333001|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
333002|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
333003|NCT01164579|E3|Reported Event|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
333004|NCT01164579|E2|Reported Event|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
333005|NCT01164579|E1|Reported Event|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
333006|NCT01164501|B4|Baseline|Total|Total of all reporting groups
333007|NCT01164501|B3|Baseline|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
333008|NCT01164501|B2|Baseline|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.
333009|NCT01164501|B1|Baseline|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
333027|NCT01164475|B2|Baseline|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
333028|NCT01164475|B1|Baseline|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
333029|NCT01164475|P2|Participant Flow|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
333030|NCT01164475|P1|Participant Flow|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (greater than or equal to [>=] 5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
333031|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
333032|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
333033|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
333034|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
333035|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
333036|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
333069|NCT01164137|E1|Reported Event|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
333097|NCT01163916|P3|Participant Flow|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
333265|NCT01163656|B2|Baseline|Glidescope Videoscope Approach|Subjects were randomly assigned to an arm.
333037|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
333038|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
333039|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
333040|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
333041|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
333042|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
333043|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
333044|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
333045|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
333046|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
333047|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
333048|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
333049|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
333050|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
333051|NCT01164475|E2|Reported Event|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
333052|NCT01164475|E1|Reported Event|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
333053|NCT01164137|B3|Baseline|Total|Total of all reporting groups
333054|NCT01164137|B2|Baseline|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
333055|NCT01164137|B1|Baseline|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
333056|NCT01164137|P2|Participant Flow|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
333057|NCT01164137|P1|Participant Flow|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
333058|NCT01164137|O2|Outcome|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
333059|NCT01164137|O1|Outcome|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
333060|NCT01164137|O2|Outcome|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
333061|NCT01164137|O1|Outcome|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
333062|NCT01164137|O2|Outcome|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
333063|NCT01164137|O1|Outcome|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
333064|NCT01164137|O2|Outcome|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
333065|NCT01164137|O1|Outcome|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
333066|NCT01164137|O2|Outcome|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
333091|NCT01163955|E2|Reported Event|Sitting on the Floor 5 Minutes|Sitting on the floor without back support, crossed leg style
333070|NCT01164007|B1|Baseline|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
333071|NCT01164007|P1|Participant Flow|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 milligrams per square meter (mg/m^2) via intravenous (IV) infusion on Day 1 and bevacizumab as 10 milligrams per kilogram (mg/kg) via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
333072|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
333073|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
333074|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
333075|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
333076|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
333077|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
333078|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
333079|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
333080|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
333081|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
333082|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
333083|NCT01164007|E1|Reported Event|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
333084|NCT01163955|B3|Baseline|Total|Total of all reporting groups
333085|NCT01163955|B2|Baseline|Sitting on the Floor 5 Minutes|Sitting on the floor without back support, crossed leg style
333086|NCT01163955|B1|Baseline|Sitting in a Chair 5 Minutes|Sitting in a chair with back support and feet flat on the ground
333087|NCT01163955|P2|Participant Flow|Sitting on the Floor 5 Minutes|Sitting on the floor without back support, crossed leg style
333088|NCT01163955|P1|Participant Flow|Sitting in a Chair 5 Minutes|Sitting in a chair with back support and feet flat on the ground
333089|NCT01163955|O2|Outcome|Postural Score Sitting in a Chair After 5 Minutes|Children sat in a chair for five minutes while playing a video game. No intervention (verbal or non-verbal) was given to them.
333090|NCT01163955|O1|Outcome|Postural Score Sitting on Floor After 5 Minutes|Children sat on the floor for five minutes while playing a video game. No intervention (verbal or non-verbal) was given to them.
333266|NCT01163656|B1|Baseline|Direct Laryngoscopy Approach|Subjects were randomly assigned to an arm.
333098|NCT01163916|P2|Participant Flow|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
333099|NCT01163916|P1|Participant Flow|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
333100|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
333101|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
333102|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
333103|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
333104|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
333105|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
333106|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
333107|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
333108|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
333109|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
333110|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
333111|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
333112|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
333113|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
333114|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
333115|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
333116|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
333117|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
333118|NCT01163916|O4|Outcome|Missing|Participants for whom acceptability data were not available.
333119|NCT01163916|O3|Outcome|Need Assistance|Participants who were unable to self-inject.
333120|NCT01163916|O2|Outcome|Not Convenient|"Participants who described the acceptability of adalimumab injections as not convenient."
333121|NCT01163916|O1|Outcome|Convenient|"Participants who described the acceptability of adalimumab injections as convenient."
333122|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
333123|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
333124|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
333125|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
333126|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
333127|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
333128|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
333129|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
333130|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis, prescribed adalimumab as part of routine clinical care in Russia.
333131|NCT01163916|E3|Reported Event|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
333132|NCT01163916|E2|Reported Event|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
333133|NCT01163916|E1|Reported Event|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
333134|NCT01163851|B3|Baseline|Total|Total of all reporting groups
333135|NCT01163851|B2|Baseline|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333136|NCT01163851|B1|Baseline|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333137|NCT01163851|P2|Participant Flow|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333226|NCT01163760|E4|Reported Event|Oculfilcon D / Ocufilcon D|ocufilcon D contact lenses worn first and second period.
333138|NCT01163851|P1|Participant Flow|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333139|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333140|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333141|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333142|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333143|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333144|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333145|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333146|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333147|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333148|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333149|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333150|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333151|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333152|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333153|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333227|NCT01163760|E3|Reported Event|Etafilcon A/ Etafilcon A|etafilcon A contact lenses worn first and second period.
336432|NCT01154816|E7|Reported Event|Childhood Hepatoblastoma|Experimental: Arm 7
333154|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333155|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333156|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333157|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333158|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333159|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333160|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333161|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333162|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333163|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333164|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333165|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333166|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333167|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333168|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333169|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333228|NCT01163760|E2|Reported Event|Ocufilcon D / Etafilcon A|ocufilcon D contact lenses worn first,etafilcon A contact lenses worn second.
343100|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
333170|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333171|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333172|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333173|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333174|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333175|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333176|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333177|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333178|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333179|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333180|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333181|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333182|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333183|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333184|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333185|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333229|NCT01163760|E1|Reported Event|Etafilcon A/ Ocufilcon D|etafilcon A contact lenses worn first,ocufilcon D contact lenses worn second
333230|NCT01163747|B3|Baseline|Total|Total of all reporting groups
333186|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333187|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333188|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333189|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333190|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333191|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333192|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333193|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333194|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333195|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333196|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333197|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333198|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333199|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333200|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333201|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333261|NCT01163721|O1|Outcome|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
333262|NCT01163721|E2|Reported Event|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
333202|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333203|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333204|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333205|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333206|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333207|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333208|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333209|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333210|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333211|NCT01163851|O2|Outcome|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333212|NCT01163851|O1|Outcome|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333213|NCT01163851|E2|Reported Event|PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333214|NCT01163851|E1|Reported Event|PF-04950615 (RN316) 4 mg/kg + Atorvastatin|Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
333215|NCT01163760|B1|Baseline|Overall|Total number of completed participants are included in baseline measurements.
333216|NCT01163760|P4|Participant Flow|Ocufilcon D First, Then Ocufilcon D|Ocufilcon D contact lenses worn for both periods.
333217|NCT01163760|P3|Participant Flow|Etafilcon A First, Then Etafilcon A|etafilcon A contact lenses worn for both periods.
333218|NCT01163760|P2|Participant Flow|Ocufilcon D First, Then Etafilcon A|ocufilcon D contact lenses worn first,etafilcon A contact lenses worn second.
333219|NCT01163760|P1|Participant Flow|Etafilcon A First, Then Ocufilcon D|etafilcon A contact lenses worn first,ocufilcon D contact lenses worn second
333220|NCT01163760|O2|Outcome|Ocufilcon D|ocufilcon D contact lenses worn in either the first or second period.
333221|NCT01163760|O1|Outcome|Etafilcon A|etafilcon A contact lenses worn in either the first or second period.
333222|NCT01163760|O2|Outcome|Ocufilcon D|ocufilcon D contact lenses worn in either the first or second period.
333223|NCT01163760|O1|Outcome|Etafilcon A|etafilcon A contact lenses worn in either the first or second period.
333224|NCT01163760|O2|Outcome|Ocufilcon D|ocufilcon D contact lenses worn in either the first or second period.
333225|NCT01163760|O1|Outcome|Etafilcon A|etafilcon A contact lenses worn in either the first or second period.
333231|NCT01163747|B2|Baseline|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
333232|NCT01163747|B1|Baseline|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
333233|NCT01163747|P2|Participant Flow|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
333234|NCT01163747|P1|Participant Flow|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
333235|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
333236|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
333237|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
333238|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
333239|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
333240|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
333241|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
333242|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
333243|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
333244|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
333245|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
333246|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
333247|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
333248|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
333249|NCT01163747|E2|Reported Event|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
333250|NCT01163747|E1|Reported Event|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
333251|NCT01163721|B3|Baseline|Total|Total of all reporting groups
333252|NCT01163721|B2|Baseline|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
333253|NCT01163721|B1|Baseline|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
333254|NCT01163721|P2|Participant Flow|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
333255|NCT01163721|P1|Participant Flow|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
333256|NCT01163721|O2|Outcome|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
333257|NCT01163721|O1|Outcome|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
333258|NCT01163721|O2|Outcome|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
333259|NCT01163721|O1|Outcome|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
333260|NCT01163721|O2|Outcome|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
333267|NCT01163656|P2|Participant Flow|Glidescope Videoscope Approach|Subjects were randomly assigned to an arm.
333268|NCT01163656|P1|Participant Flow|Direct Laryngoscopy Approach|Subjects were randomly assigned to an arm.
333269|NCT01163656|O2|Outcome|Glidescope Videoscope Approach|Subjects were randomly assigned to an arm.
333270|NCT01163656|O1|Outcome|Direct Laryngoscopy Approach|Subjects were randomly assigned to an arm.
333271|NCT01163656|E2|Reported Event|Glidescope Videoscope Approach|Subjects were randomly assigned to an arm.
333272|NCT01163656|E1|Reported Event|Direct Laryngoscopy Approach|Subjects were randomly assigned to an arm.
333273|NCT01163617|B1|Baseline|All Study Participants|Includes participants from Phases A and B of the study
333274|NCT01163617|P8|Participant Flow|Current Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at room temperature (20° to 27°C) (Phase B)
333275|NCT01163617|P7|Participant Flow|Physiolis Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at room temperature (20° to 27°C) (Phase B)
333276|NCT01163617|P6|Participant Flow|Current Autoinjector 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) (Phase B)
333277|NCT01163617|P5|Participant Flow|Physiolis Autoinjector at 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C) (Phase B)
333278|NCT01163617|P4|Participant Flow|Physiolis Autoinjector First, Then Current Autoinjector|Self-injection using Physiolis autoinjector at Week 0 (Visit 1), self-injection using current autoinjector at Week 2 (Visit 2) (Phase A)
333279|NCT01163617|P3|Participant Flow|Current Autoinjector First, Then Physiolis Autoinjector|Self-injection using current autoinjector at Week 0 (Visit 1), self-injection using Physiolis autoinjector at Week 2 (Visit 2) (Phase A)
333280|NCT01163617|P2|Participant Flow|Physiolis Syringe First, Then Current Syringe|Self-injection using Physiolis syringe at Week 0 (Visit 1), self-injection using current syringe at Week 2 (Visit 2) (Phase A)
333281|NCT01163617|P1|Participant Flow|Current Syringe First, Then Physiolis Syringe|Self-injection using current syringe at Week 0 (Visit 1), self-injection using Physiolis syringe at Week 2 (Visit 2) (Phase A)
333282|NCT01163617|O2|Outcome|Current Autoinjector 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C)
333283|NCT01163617|O1|Outcome|Current Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at room temperature (20° to 27°C)
333284|NCT01163617|O2|Outcome|Physiolis Autoinjector|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C) and room temperature (20° to 27°C)
333285|NCT01163617|O1|Outcome|Current Autoinjector|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) and room temperature (20° to 27°C)
333286|NCT01163617|O2|Outcome|Physiolis Autoinjector at 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C)
333287|NCT01163617|O1|Outcome|Physiolis Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at room temperature (20° to 27°C)
333288|NCT01163617|O4|Outcome|Physiolis/Current Autoinjector|Self-injection using Physiolis autoinjector at Week 0 (Visit 1), self-injection using current autoinjector at Week 2 (Visit 2)
333289|NCT01163617|O3|Outcome|Current/Physiolis Autoinjector|Self-injection using current autoinjector at Week 0 (Visit 1), self-injection using Physiolis autoinjector at Week 2 (Visit 2)
333290|NCT01163617|O2|Outcome|Physiolis/Current Syringe|Self-injection using Physiolis syringe at Week 0 (Visit 1), self-injection using current syringe at Week 2 (Visit 2)
333291|NCT01163617|O1|Outcome|Current/Physiolis Syringe|Self-injection using current syringe at Week 0 (Visit 1), self-injection using Physiolis syringe at Week 2 (Visit 2)
333292|NCT01163617|E8|Reported Event|Current Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at room temperature (20° to 27°C) (Phase B)
333293|NCT01163617|E7|Reported Event|Physiolis Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at room temperature (20° to 27°C) (Phase B)
333294|NCT01163617|E6|Reported Event|Current Autoinjector 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) (Phase B)
333295|NCT01163617|E5|Reported Event|Physiolis Autoinjector at 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C) (Phase B)
333296|NCT01163617|E4|Reported Event|Physiolis Autoinjector|Self-injection using Physiolis autoinjector at Week 0 or Week 2 (Visit 2) (Phase A)
333297|NCT01163617|E3|Reported Event|Current Autoinjector|Self-injection using current autoinjector at Week 0 (Visit 1) or Week 2 (Visit 2) (Phase A)
333298|NCT01163617|E2|Reported Event|Physiolis Syringe|Self-injection using Physiolis syringe at Week 0 (Visit 1) or Week 2 (Visit 2) (Phase A)
333299|NCT01163617|E1|Reported Event|Current Syringe|Self-injection using current syringe at Week 0 (Visit 1) or Week 2 (Visit 2) (Phase A)
333300|NCT01163604|B3|Baseline|Total|Total of all reporting groups
333301|NCT01163604|B2|Baseline|Non-argatroban Treated Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.~non-argatroban treated group: Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment."
333302|NCT01163604|B1|Baseline|Argatroban Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive continuous infusions of argatroban for 2 days before and 3 days after stenting, with accompanied aspirin and clopidogrel treatment.~Argatroban: Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment"
333337|NCT01163292|O1|Outcome|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
336433|NCT01154816|E6|Reported Event|Recurrent Childhood Soft Tissue Sarcoma|Experimental: Arm 6
333303|NCT01163604|P2|Participant Flow|"Aspirin and Clopidogrel Interventions Group"|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.~non-argatroban treated group: Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment."
333304|NCT01163604|P1|Participant Flow|Argatroban Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive continuous infusions of argatroban for 2 days before and 3 days after stenting, with accompanied aspirin and clopidogrel treatment.~Argatroban: Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment"
333305|NCT01163604|O2|Outcome|Non-argatroban Treated Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.~non-argatroban treated group: Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment."
333306|NCT01163604|O1|Outcome|Argatroban Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive continuous infusions of argatroban for 2 days before and 3 days after stenting, with accompanied aspirin and clopidogrel treatment.~Argatroban: Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment"
333307|NCT01163604|E2|Reported Event|Non-argatroban Treated Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.~non-argatroban treated group: Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment."
333308|NCT01163604|E1|Reported Event|Argatroban Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive continuous infusions of argatroban for 2 days before and 3 days after stenting, with accompanied aspirin and clopidogrel treatment.~Argatroban: Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment"
333309|NCT01163474|B1|Baseline|Arm 1 - Evaluate Video Clinic Visit|Evaluate video clinic visit prior to Face-to-Face usual care visit
333310|NCT01163474|P1|Participant Flow|Arm 1 - Evaluate Video Clinic Visit Prior to Face-to-Face Usua|Evaluate video clinic visit prior to Face-to-Face usual care visit
333311|NCT01163474|O1|Outcome|Arm 1 - Provider Evaluate Video Conferencing|"Evaluate virtual video conference follow-up clinic visit~Evaluative process: Evaluative process using video conferencing"
333312|NCT01163474|O1|Outcome|Arm 1 - Evaluate Video Conferencing|"Evaluate virtual video conference follow-up clinic visit~Evaluative process: Evaluative process using video conferencing"
333313|NCT01163474|E2|Reported Event|Arm 2|Face-to-face follow up for subjects (control)
333314|NCT01163474|E1|Reported Event|Arm 1 - Evaluate Video Conferencing|"Evaluate virtual video conference follow-up clinic visit~Evaluative process: Evaluative process using video conferencing"
333315|NCT01163461|B1|Baseline|Behavioral Aphasia Therapy|Single group, open trail where 28 individuals with aphasia received 60 hours of therapy
333316|NCT01163461|P2|Participant Flow|Immediate Aphasia Therapy|14 individuals were randomized to received 60 hours of aphasia therapy immediately following testing. (no delay)
333317|NCT01163461|P1|Participant Flow|Delayed Aphasia Therapy|14 individuals were randomized to received aphasia therapy following a 6-week control delay phase. Upon completion of the 6-week control phase, they received 60 hours of behavioral therapy
333318|NCT01163461|O1|Outcome|Behavioral Aphasia Therapy|Single group, open trail where 28 individuals with aphasia received 60 hours of therapy
333319|NCT01163461|E1|Reported Event|Single Group Open Trial|28 individuals were randomized to receive either immediate speech therapy, or delayed speech therapy (following a 6 week delay period to control for Hawthorne effects). All participants received 60 hours of speech therapy 2 hours/day, 5 days/week for 6 weeks. Language behaviors were testing before, after and 3 months later.
333320|NCT01163318|B1|Baseline|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
333321|NCT01163318|P1|Participant Flow|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
333322|NCT01163318|O1|Outcome|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
333323|NCT01163318|O1|Outcome|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
333324|NCT01163318|O1|Outcome|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
333325|NCT01163318|O1|Outcome|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
333326|NCT01163318|E1|Reported Event|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
333327|NCT01163292|B3|Baseline|Total|Total of all reporting groups
333328|NCT01163292|B2|Baseline|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
333329|NCT01163292|B1|Baseline|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
333330|NCT01163292|P2|Participant Flow|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
333331|NCT01163292|P1|Participant Flow|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
333332|NCT01163292|O2|Outcome|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
333333|NCT01163292|O1|Outcome|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
333334|NCT01163292|O2|Outcome|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
333335|NCT01163292|O1|Outcome|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
333336|NCT01163292|O2|Outcome|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
333338|NCT01163292|O2|Outcome|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
333339|NCT01163292|O1|Outcome|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
333340|NCT01163292|O2|Outcome|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
333341|NCT01163292|O1|Outcome|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
333342|NCT01163292|E2|Reported Event|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
333343|NCT01163292|E1|Reported Event|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
333344|NCT01163279|B3|Baseline|Total|Total of all reporting groups
333345|NCT01163279|B2|Baseline|Psychosocial Education|The active comparator uses an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants will receive factual information on brain structure and function, age-related cognitive changes, and general brain health issues and will spend time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework will consist of reading assignments related to the session topics.
333346|NCT01163279|B1|Baseline|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
333347|NCT01163279|P2|Participant Flow|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
333348|NCT01163279|P1|Participant Flow|Cogntive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
333349|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
333350|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
333351|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
333352|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
333353|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
333354|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
333395|NCT01163266|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
333396|NCT01163266|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
333355|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
333356|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
333357|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
333358|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
333359|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
333360|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
333361|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
333362|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
333363|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
333364|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
333365|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
333366|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
333397|NCT01163266|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
333937|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333367|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
333368|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
333369|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator uses an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants will receive factual information on brain structure and function, age-related cognitive changes, and general brain health issues and will spend time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework will consist of reading assignments related to the session topics.
333370|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
333371|NCT01163279|E2|Reported Event|Psychosocial Education|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
333372|NCT01163279|E1|Reported Event|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
333373|NCT01163266|B4|Baseline|Total|Total of all reporting groups
333374|NCT01163266|B3|Baseline|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
333375|NCT01163266|B2|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
333376|NCT01163266|B1|Baseline|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
333377|NCT01163266|P3|Participant Flow|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
333378|NCT01163266|P2|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
333379|NCT01163266|P1|Participant Flow|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
333380|NCT01163266|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
333381|NCT01163266|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
333382|NCT01163266|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
333383|NCT01163266|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
333384|NCT01163266|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
333385|NCT01163266|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
333386|NCT01163266|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
333387|NCT01163266|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
333388|NCT01163266|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
333389|NCT01163266|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
333390|NCT01163266|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
333391|NCT01163266|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
333392|NCT01163266|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
333393|NCT01163266|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
333394|NCT01163266|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
333983|NCT01161862|O2|Outcome|Bionic Pancreas Without Automated Meal-priming Bolus|
333398|NCT01163266|E3|Reported Event|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
333399|NCT01163266|E2|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
333400|NCT01163266|E1|Reported Event|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
333401|NCT01163253|B3|Baseline|Total|Total of all reporting groups
333402|NCT01163253|B2|Baseline|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333403|NCT01163253|B1|Baseline|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333404|NCT01163253|P2|Participant Flow|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333405|NCT01163253|P1|Participant Flow|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333406|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333407|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333408|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333409|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333410|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333411|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333412|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333413|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333414|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333415|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333416|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333417|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333418|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333419|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333420|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333421|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333422|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333423|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333424|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333425|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333426|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333427|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333428|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333429|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333430|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333431|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333432|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333433|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333434|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333435|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333436|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333437|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333438|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333439|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333440|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333441|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333627|NCT01163149|O1|Outcome|0.3 mg/kg Asfotase Alfa|Asfotase alfa Cohort 1: Daily SC injections of 0.3 mg/kg asfotase alfa (2.1 mg/kg/week total)
333442|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333443|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333444|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333445|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333446|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333447|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333448|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333449|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333450|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333451|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333452|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333453|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333454|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333455|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333456|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333457|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333458|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333459|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333460|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333461|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333584|NCT01163162|P1|Participant Flow|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
343101|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
333462|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333463|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333464|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333465|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333466|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333467|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333468|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333469|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333470|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333471|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333472|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333473|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333474|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333475|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333476|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333477|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333478|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333479|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333480|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333481|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333585|NCT01163162|O1|Outcome|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
337406|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
333482|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333483|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333484|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333485|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333486|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333487|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333488|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333489|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333490|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333491|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333492|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333493|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333494|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333495|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333496|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333497|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333498|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333499|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333500|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333501|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333586|NCT01163162|O1|Outcome|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
337407|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
333502|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333503|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333504|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333505|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333506|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333507|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333508|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333509|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333510|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333511|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333512|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333513|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333514|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333515|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333516|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333517|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333518|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333519|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333520|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333521|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333587|NCT01163162|O1|Outcome|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
337408|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
333522|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333523|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333524|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333525|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333526|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333527|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333528|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333529|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333530|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333531|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333532|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333533|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333534|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333535|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333536|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333537|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333538|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333539|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333540|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333541|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333588|NCT01163162|E1|Reported Event|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
333589|NCT01163149|B4|Baseline|Total|Total of all reporting groups
333542|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333543|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333544|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333545|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333546|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333547|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333548|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333549|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333550|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333551|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333552|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333553|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333554|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333555|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333556|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333557|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333558|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333559|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333560|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333561|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333623|NCT01163149|O1|Outcome|0.3 mg/kg Asfotase Alfa|Primary Treatment Period (first 24 week). Asfotase alfa Cohort 1: Daily SC injections of 0.3 mg/kg asfotase alfa (2.1 mg/kg/week total).
333624|NCT01163149|O4|Outcome|Combined Asfotase Alfa Group|Subjects from Cohort 1 and Cohort 2 treated with asfotase alfa during primary treatment period (first 24 weeks)
333562|NCT01163253|E2|Reported Event|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
333563|NCT01163253|E1|Reported Event|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
333564|NCT01163214|B3|Baseline|Total|Total of all reporting groups
333565|NCT01163214|B2|Baseline|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
333566|NCT01163214|B1|Baseline|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
333567|NCT01163214|P2|Participant Flow|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
333568|NCT01163214|P1|Participant Flow|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
333569|NCT01163214|O2|Outcome|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
333570|NCT01163214|O1|Outcome|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
333571|NCT01163214|O2|Outcome|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
333572|NCT01163214|O1|Outcome|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
333573|NCT01163214|O2|Outcome|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
333574|NCT01163214|O1|Outcome|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
333575|NCT01163214|O2|Outcome|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
333576|NCT01163214|O1|Outcome|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
333577|NCT01163214|O2|Outcome|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
333578|NCT01163214|O1|Outcome|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
333579|NCT01163214|O2|Outcome|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
333580|NCT01163214|O1|Outcome|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
333581|NCT01163214|E2|Reported Event|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
333582|NCT01163214|E1|Reported Event|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
333583|NCT01163162|B1|Baseline|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
337409|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
333590|NCT01163149|B3|Baseline|Concurrent Control|"No asfotase alfa during first 24 weeks (primary treatment period).~Following completion of the Week 24 visit, all subjects randomized to the concurrent control cohort were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug"
333591|NCT01163149|B2|Baseline|0.5 mg/kg Asfotase Alfa|"Asfotase alfa: Cohort 2: Daily SC injections of 0.5 mg/kg asfotase alfa (3.5 mg/kg/week total) during Primary Treatment Period through Week 24.~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
333592|NCT01163149|B1|Baseline|0.3 mg/kg Asfotase Alfa|"Asfotase alfa: Cohort 1: Daily SC injections of 0.3 mg/kg asfotase alfa (total of 2.1 mg/kg/week) during Primary Treatment Period through Week 24.~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
333593|NCT01163149|P3|Participant Flow|Concurrent Control|"No asfotase alfa during first 24 weeks (primary treatment period).~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
333594|NCT01163149|P2|Participant Flow|0.5 mg/kg Asfotase Alfa|"Asfotase alfa Cohort 2: Daily SC injections of 0.5 mg/kg asfotase alfa (3.5 mg/kg/week total).~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
333595|NCT01163149|P1|Participant Flow|0.3 mg/kg Asfotase Alfa|"Asfotase alfa Cohort 1: Daily SC injections of 0.3 mg/kg asfotase alfa (2.1 mg/kg/week total).~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
333596|NCT01163149|O4|Outcome|Asfotase Alfa Combined|Subjects from primary treatment period asfotase alfa groups.
333597|NCT01163149|O3|Outcome|Concurrent Control|"No asfotase alfa during first 24 weeks (primary treatment period).~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
333598|NCT01163149|O2|Outcome|0.5 mg/kg Asfotase Alfa|"Asfotase alfa Cohort 2: Daily SC injections of 0.5 mg/kg asfotase alfa (3.5 mg/kg/week total) during Primary Treatment Period through Week 24.~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
333599|NCT01163149|O1|Outcome|0.3 mg/kg Asfotase Alfa|"Asfotase alfa Cohort 1: Daily SC injections of 0.3 mg/kg asfotase alfa (2.1 mg/kg/week total) during Primary Treatment Period through Week 24.~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
333600|NCT01163149|O4|Outcome|Asfotase Alfa Combined|Subjects from primary treatment period asfotase alfa groups.
333601|NCT01163149|O3|Outcome|Concurrent Control|"No asfotase alfa during first 24 weeks (primary treatment period).~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
333602|NCT01163149|O2|Outcome|0.5 mg/kg Asfotase Alfa|"Asfotase alfa Cohort 2: Daily SC injections of 0.5 mg/kg asfotase alfa (3.5 mg/kg/week total) during Primary Treatment Period through Week 24.~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
333603|NCT01163149|O1|Outcome|0.3 mg/kg Asfotase Alfa|"Asfotase alfa Cohort 1: Daily SC injections of 0.3 mg/kg asfotase alfa (2.1 mg/kg/week total) during Primary Treatment Period through Week 24.~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
333604|NCT01163149|O4|Outcome|Asfotase Alfa Combined|Subjects from primary treatment period asfotase alfa groups.
333605|NCT01163149|O3|Outcome|Concurrent Control|"No asfotase alfa during first 24 weeks (primary treatment period).~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
333625|NCT01163149|O3|Outcome|Concurrent Control|Control (no asfotase alfa) during primary treatment period (first 24 weeks)
333606|NCT01163149|O2|Outcome|0.5 mg/kg Asfotase Alfa|"Asfotase alfa Cohort 2: Daily SC injections of 0.5 mg/kg asfotase alfa (3.5 mg/kg/week total) during Primary Treatment Period through Week 24.~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
333607|NCT01163149|O1|Outcome|0.3 mg/kg Asfotase Alfa|"Asfotase alfa Cohort 1: Daily SC injections of 0.3 mg/kg asfotase alfa (2.1 mg/kg/week total) during Primary Treatment Period through Week 24.~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
333608|NCT01163149|O4|Outcome|Asfotase Alfa Combined|Subjects From Cohort 1 and Cohort 2 treated with asfotase alfa (N=13) during Primary Treatment Period, and all subjects exposed to asfotase alfa (N=19) during extension treatment period.
333609|NCT01163149|O3|Outcome|Concurrent Control|"No asfotase alfa during first 24 weeks (primary treatment period).~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
333610|NCT01163149|O2|Outcome|0.5 mg/kg Asfotase Alfa|"Asfotase alfa Cohort 2: Daily SC injections of 0.5 mg/kg asfotase alfa (3.5 mg/kg/week total) during Primary Treatment Period through Week 24.~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
333611|NCT01163149|O1|Outcome|0.3 mg/kg Asfotase Alfa|"Asfotase alfa Cohort 1: Daily SC injections of 0.3 mg/kg asfotase alfa (2.1 mg/kg/week total) during Primary Treatment Period through Week 24.~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
333612|NCT01163149|O4|Outcome|Asfotase Alfa Combined|All subjects from Cohort 1, Cohort 2, or Control group with any asfotase alfa exposure. During primary treatment period, N=13. During open-label extension treatment period, N=19.
333613|NCT01163149|O3|Outcome|Concurrent Control|"No asfotase alfa during first 24 weeks (primary treatment period).~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
333614|NCT01163149|O2|Outcome|0.5 mg/kg Asfotase Alfa|"Asfotase alfa: Cohort 2: Daily SC injections of 0.5 mg/kg Asfotase Alfa (3.5 mg/kg/week total) during Primary Treatment Period through Week 24.~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
333615|NCT01163149|O1|Outcome|0.3 mg/kg Asfotase Alfa|"Asfotase alfa: Cohort 1: Daily SC injections of 0.3 mg/kg asfotase alfa (total of 2.1 mg/kg/week) during Primary Treatment Period through Week 24.~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
333616|NCT01163149|O4|Outcome|Asfotase Alfa Combined|All subjects from Cohort 1, Cohort 2, or Control group with any asfotase alfa exposure. During primary treatment period, N=13. During open-label extension treatment period, N=19.
333617|NCT01163149|O3|Outcome|Concurrent Control|"No asfotase alfa during first 24 weeks (primary treatment period).~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
333618|NCT01163149|O2|Outcome|0.5 mg/kg Asfotase Alfa|"Asfotase alfa: Cohort 2: Daily SC injections of 0.5 mg/kg Asfotase Alfa (3.5 mg/kg/week total) during Primary Treatment Period through Week 24.~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
333619|NCT01163149|O1|Outcome|0.3 mg/kg Asfotase Alfa|"Asfotase alfa: Cohort 1: Daily SC injections of 0.3 mg/kg asfotase alfa (total of 2.1 mg/kg/week) during Primary Treatment Period through Week 24.~Following completion of the Week 24 visit, all subjects were eligible to participate in an open-label extension treatment period. In this extension period, all subjects were treated with daily SC injections of 0.5 mg/kg/day asfotase alfa (a total of 3.5 mg/kg/week) for approximately 24 weeks, then subjects received 1 mg/kg/day 6 days/week until regulatory approval of the drug."
333620|NCT01163149|O4|Outcome|Cumulative Exposure to Asfotase Alfa|All subjects from Cohort 1, Cohort 2, or Control group with any asfotase alfa exposure. During primary treatment period, N=13. During open-label extension treatment period, N=19.
333621|NCT01163149|O3|Outcome|Concurrent Control|No asfotase alfa during primary treatment period: (first 24 weeks).
333622|NCT01163149|O2|Outcome|0.5 mg/kg Asfotase Alfa|Primary Treatment Period (first 24 weeks). Asfotase alfa Cohort 2: Daily SC injections of 0.5 mg/kg asfotase alfa (3.5 mg/kg/week total).
333626|NCT01163149|O2|Outcome|0.5 mg/kg Asfotase Alfa|Asfotase alfa Cohort 2: Daily SC injections of 0.5 mg/kg asfotase alfa (3.5 mg/kg/week total)
333628|NCT01163149|O4|Outcome|Combined Asfotase Alfa Group|Subjects from Cohort 1 and Cohort 2 treated with asfotase alfa during primary treatment period (first 24 weeks)
333629|NCT01163149|O3|Outcome|Concurrent Control|Control (no asfotase alfa) during primary treatment period (first 24 weeks)
333630|NCT01163149|O2|Outcome|0.5 mg/kg Asfotase Alfa|Asfotase alfa Cohort 2: Daily SC injections of 0.5 mg/kg asfotase alfa (3.5 mg/kg/week total)
333631|NCT01163149|O1|Outcome|0.3 mg/kg Asfotase Alfa|Asfotase alfa Cohort 1: Daily SC injections of 0.3 mg/kg asfotase alfa (2.1 mg/kg/week total)
333632|NCT01163149|E4|Reported Event|Cumulative Exposure to Asfotase Alfa|Adverse events occurring in subjects from Cohort 1, Cohort 2 and original Control group during exposure to asfotase alfa.
333633|NCT01163149|E3|Reported Event|Concurrent Control (First 24 Weeks)|"No asfotase alfa treatment during primary treatment period: first 24 weeks.~After 24 weeks, Control Group subjects were eligible to begin asfotase alfa treatment in the open-label extension treatment period."
333634|NCT01163149|E2|Reported Event|0.5 mg/kg Asfotase Alfa (First 24 Weeks)|Asfotase alfa Cohort 2: Daily SC injections of 0.5 mg/kg asfotase alfa (3.5 mg/kg/week total)
333635|NCT01163149|E1|Reported Event|0.3 mg/kg Asfotase Alfa (First 24 Weeks)|Asfotase alfa Cohort 1: Daily SC injections of 0.3 mg/kg asfotase alfa (2.1 mg/kg/week total)
333636|NCT01163097|B4|Baseline|Total|Total of all reporting groups
333637|NCT01163097|B3|Baseline|Untreated Control|Treatment C: control group without any treatment administered
333638|NCT01163097|B2|Baseline|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
333639|NCT01163097|B1|Baseline|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
333640|NCT01163097|P3|Participant Flow|Untreated Control|Treatment C: control group without any treatment administered
333641|NCT01163097|P2|Participant Flow|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
333642|NCT01163097|P1|Participant Flow|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
333643|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
333644|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
333645|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
333646|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
333647|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
333648|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
333649|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
333650|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
333651|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
333652|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
333653|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
333654|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
333655|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
333656|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
333657|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
333658|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
333659|NCT01163097|O3|Outcome|Untreated Control|Treatment C: control group without any treatment administered
333660|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
333661|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
333662|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
333663|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
333664|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
333665|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
333666|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
333667|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
333668|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
333669|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
333670|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
333671|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
333672|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
333673|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
333674|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
333675|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
333676|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
333677|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
333678|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
333679|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
333680|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
333681|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
333682|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
333683|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
333684|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
333685|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
333686|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
333687|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
333688|NCT01163097|E3|Reported Event|Untreated Control|Treatment C: control group without any treatment administered
333689|NCT01163097|E2|Reported Event|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
333690|NCT01163097|E1|Reported Event|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
333691|NCT01163032|B4|Baseline|Total|Total of all reporting groups
333692|NCT01163032|B3|Baseline|Open Label Tasimelteon|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
333693|NCT01163032|B2|Baseline|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
333694|NCT01163032|B1|Baseline|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
333695|NCT01163032|P3|Participant Flow|Open Label Tasimelteon|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
333696|NCT01163032|P2|Participant Flow|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
333697|NCT01163032|P1|Participant Flow|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
333698|NCT01163032|O1|Outcome|Open Label Tasimelteon|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
333699|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
333700|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
333701|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
333702|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
333703|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
333704|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
333705|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
333706|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
333707|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
333708|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
333709|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
333710|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
333711|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
333712|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
333713|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
333714|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
333715|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
333716|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
333717|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
333718|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
334184|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program.
333719|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
333720|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
333721|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
333722|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
333723|NCT01163032|E3|Reported Event|Open Label Tasimelteon|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
333724|NCT01163032|E2|Reported Event|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
333725|NCT01163032|E1|Reported Event|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
333726|NCT01162863|B4|Baseline|Total|Total of all reporting groups
333727|NCT01162863|B3|Baseline|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
333728|NCT01162863|B2|Baseline|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
333729|NCT01162863|B1|Baseline|Placebo|"Placebo: taken orally for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
333730|NCT01162863|P3|Participant Flow|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
333731|NCT01162863|P2|Participant Flow|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
333732|NCT01162863|P1|Participant Flow|Placebo|"Placebo: taken orally for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
333733|NCT01162863|O3|Outcome|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
333734|NCT01162863|O2|Outcome|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
333735|NCT01162863|O1|Outcome|Placebo|"Placebo: taken orally for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
333736|NCT01162863|O3|Outcome|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
333737|NCT01162863|O2|Outcome|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
333738|NCT01162863|O1|Outcome|Placebo|"Placebo: taken orally for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
333739|NCT01162863|O3|Outcome|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
333740|NCT01162863|O2|Outcome|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
333741|NCT01162863|O1|Outcome|Placebo|"Placebo: taken orally for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
333742|NCT01162863|E3|Reported Event|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
334332|NCT01160822|B2|Baseline|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
333743|NCT01162863|E2|Reported Event|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
333744|NCT01162863|E1|Reported Event|Placebo|"Placebo: taken orally for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
333745|NCT01162733|B3|Baseline|Total|Total of all reporting groups
333746|NCT01162733|B2|Baseline|Study Drug 2|"Vancomycin 30mg/kg~Vancomycin : 30mg/kg"
333747|NCT01162733|B1|Baseline|Study Drug 1|"Vancomycin 15mg/kg~Vancomycin : 15mg/kg"
333748|NCT01162733|P2|Participant Flow|Study Drug 2|"Vancomycin 30mg/kg~Vancomycin : 30mg/kg"
333749|NCT01162733|P1|Participant Flow|Study Drug 1|"Vancomycin 15mg/kg~Vancomycin : 15mg/kg"
333750|NCT01162733|O2|Outcome|Study Drug 2|"Vancomycin 30mg/kg~Vancomycin : 30mg/kg"
333751|NCT01162733|O1|Outcome|Study Drug 1|"Vancomycin 15mg/kg~Vancomycin : 15mg/kg"
333752|NCT01162733|O2|Outcome|Study Drug 2|"Vancomycin 30mg/kg~Vancomycin : 30mg/kg"
333753|NCT01162733|O1|Outcome|Study Drug 1|"Vancomycin 15mg/kg~Vancomycin : 15mg/kg"
333754|NCT01162733|E2|Reported Event|Study Drug 2|"Vancomycin 30mg/kg~Vancomycin : 30mg/kg"
333755|NCT01162733|E1|Reported Event|Study Drug 1|"Vancomycin 15mg/kg~Vancomycin : 15mg/kg"
333756|NCT01162499|B1|Baseline|Subject Population|All subjects enrolled and treated in the protocol served as their own control. Because of this and the small sample size, baseline characteristic data is presented together.
333757|NCT01162499|P2|Participant Flow|Vehicle First, Then Exendin-(9-39)|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The next day, all procedures were repeated except subjects received an IV infusion of Exendin-(9-39) which was started 1 hour prior to the meal challenge and continued for 4 hours. The dose for the first 3 subjects was 300pmol/kg/min and, as planned, it was increased to 500pmol/kg/min for subsequent subjects.
333758|NCT01162499|P1|Participant Flow|Exendin-(9-39) First, Then Vehicle|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose for the first 3 subjects was 300pmol/kg/min and, as planned, it was increased to 500pmol/kg/min for subsequent subjects. The next day, all procedures were repeated except subjects received an IV infusion of normal saline (vehicle) over 4 hours.
333759|NCT01162499|O3|Outcome|Vehicle|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The vehicle was infused over 4 total hours.
333760|NCT01162499|O2|Outcome|Exendin-(9-39) 500pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 500pmol/kg/min, infused over 4 total hours.
333761|NCT01162499|O1|Outcome|Exendin-(9-39) 300pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 300pmol/kg/min, infused over 4 total hours.
333762|NCT01162499|O3|Outcome|Vehicle|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The vehicle was infused over 4 total hours.
333763|NCT01162499|O2|Outcome|Exendin-(9-39) 500pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 500pmol/kg/min, infused over 4 total hours.
333764|NCT01162499|O1|Outcome|Exendin-(9-39) 300pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 300pmol/kg/min, infused over 4 total hours.
333806|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333765|NCT01162499|O3|Outcome|Vehicle|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The vehicle was infused over 4 total hours.
333766|NCT01162499|O2|Outcome|Exendin-(9-39) 500pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 500pmol/kg/min, infused over 4 total hours.
333767|NCT01162499|O1|Outcome|Exendin-(9-39) 300pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 300pmol/kg/min, infused over 4 total hours.
333768|NCT01162499|O3|Outcome|Vehicle|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The vehicle was infused over 4 total hours.
333769|NCT01162499|O2|Outcome|Exendin-(9-39) 500pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 500pmol/kg/min, infused over 4 total hours.
333770|NCT01162499|O1|Outcome|Exendin-(9-39) 300pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 300pmol/kg/min, infused over 4 total hours.
333771|NCT01162499|O3|Outcome|Vehicle|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The vehicle was infused over 4 total hours.
333772|NCT01162499|O2|Outcome|Exendin-(9-39) 500pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 500pmol/kg/min, infused over 4 total hours.
333773|NCT01162499|O1|Outcome|Exendin-(9-39) 300pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 300pmol/kg/min, infused over 4 total hours.
333774|NCT01162499|E3|Reported Event|Vehicle|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The vehicle was infused over 4 total hours.
333775|NCT01162499|E2|Reported Event|Exendin-(9-39) 500pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 500pmol/kg/min, infused over 4 total hours.
333776|NCT01162499|E1|Reported Event|Exendin-(9-39) 300pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 300pmol/kg/min, infused over 4 total hours.
333777|NCT01162473|B3|Baseline|Total|Total of all reporting groups
333778|NCT01162473|B2|Baseline|Immediate Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 3 and continued thru Week 35. Total active participation lasted 38 weeks.
333779|NCT01162473|B1|Baseline|Delayed Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 16 and continued thru Week 50. Total active participation lasted 51 weeks.
333780|NCT01162473|P2|Participant Flow|Immediate Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 3 and continued thru Week 35. Total active participation lasted 38 weeks.
333781|NCT01162473|P1|Participant Flow|Delayed Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 16 and continued thru Week 50. Total active participation lasted 51 weeks.
333782|NCT01162473|O2|Outcome|Immediate Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 3 and continued thru Week 35. Total active participation lasted 38 weeks.
333783|NCT01162473|O1|Outcome|Delayed Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 16 and continued thru Week 50. Total active participation lasted 51 weeks.
333784|NCT01162473|E2|Reported Event|Immediate Desensitization|Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder (29 week protocol)
333785|NCT01162473|E1|Reported Event|Delayed Desensitization|Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder (42 week protocol).
333786|NCT01162421|B3|Baseline|Total|Total of all reporting groups
333787|NCT01162421|B2|Baseline|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333788|NCT01162421|B1|Baseline|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333789|NCT01162421|P2|Participant Flow|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333790|NCT01162421|P1|Participant Flow|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333791|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333792|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333793|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333794|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333795|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333796|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333797|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333798|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333799|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333800|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333801|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333802|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333803|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333804|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333805|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
334333|NCT01160822|B1|Baseline|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
333807|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333808|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333809|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333810|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333811|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333812|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333813|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333814|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333815|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333816|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333817|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333818|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333819|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333820|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333821|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333822|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333823|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333824|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333825|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333826|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333827|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333828|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333829|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333830|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333831|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333832|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333833|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333834|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333835|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333836|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333837|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333838|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333839|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333840|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333841|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333842|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333843|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333844|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333845|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333846|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333847|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333848|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333849|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333850|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333851|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333852|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333853|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333854|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333855|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333856|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333857|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333858|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333859|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333860|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333861|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333862|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333863|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333864|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333865|NCT01162421|E2|Reported Event|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
333866|NCT01162421|E1|Reported Event|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
333867|NCT01162343|B1|Baseline|Older Emergency Department Patients|Patients who were 65 years or older from the emergency department were enrolled.
333868|NCT01162343|P1|Participant Flow|Older Emergency Department Patients|Patients who were 65 years or older from the emergency department were enrolled.
333869|NCT01162343|O1|Outcome|Older Emergency Department Patients|Patients who were 65 years or older from the emergency department were enrolled.
333870|NCT01162343|E1|Reported Event|Older Emergency Department Patients|Patients who were 65 years or older from the emergency department were enrolled.
333871|NCT01162317|B3|Baseline|Total|Total of all reporting groups
333872|NCT01162317|B2|Baseline|Arm 2: Acupuncture|"acupuncture~Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes."
333873|NCT01162317|B1|Baseline|Arm 1: Sham Acupuncture|"sham acupuncture~Sham Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes. Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration."
333874|NCT01162317|P2|Participant Flow|Arm 2: Acupuncture|"acupuncture~Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes."
333875|NCT01162317|P1|Participant Flow|Arm 1: Sham Acupuncture|"sham acupuncture~Sham Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes. Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration."
333876|NCT01162317|O2|Outcome|Arm 2: Acupuncture|"acupuncture~Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes."
333877|NCT01162317|O1|Outcome|Arm 1: Sham Acupuncture|"sham acupuncture~Sham Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes. Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration."
333878|NCT01162317|O2|Outcome|Arm 2: Acupuncture|"acupuncture~Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes."
343102|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
333879|NCT01162317|O1|Outcome|Arm 1: Sham Acupuncture|"sham acupuncture~Sham Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes. Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration."
333880|NCT01162317|E2|Reported Event|Arm 2: Acupuncture|"acupuncture~Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes."
333881|NCT01162317|E1|Reported Event|Arm 1: Sham Acupuncture|"sham acupuncture~Sham Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes. Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration."
333882|NCT01162304|B1|Baseline|ER Oxycodone vs IR Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours~IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours~Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
333883|NCT01162304|P1|Participant Flow|ER Oxycodone vs IR Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours~IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
333884|NCT01162304|O2|Outcome|Immediate Release Oxycodone|"IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours~Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
333885|NCT01162304|O1|Outcome|Extended Release Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours"
333886|NCT01162304|O2|Outcome|Immediate Release Oxycodone|"IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours~Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
333887|NCT01162304|O1|Outcome|Extended Release Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours"
333888|NCT01162304|O2|Outcome|Immediate Release Oxycodone|"IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours~Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
333889|NCT01162304|O1|Outcome|Extended Release Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours"
333890|NCT01162304|O2|Outcome|Immediate Release Oxycodone|"IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours~Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
333891|NCT01162304|O1|Outcome|Extended Release Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours"
333892|NCT01162304|O2|Outcome|Immediate Release Oxycodone|"IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours~Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
333893|NCT01162304|O1|Outcome|Extended Release Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours"
333894|NCT01162304|E2|Reported Event|Immediate Release Oxycodone|"IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours~Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
333936|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333895|NCT01162304|E1|Reported Event|Extended Release Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours"
333896|NCT01162135|B1|Baseline|Digoxin|Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
333897|NCT01162135|P1|Participant Flow|Digoxin|Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
333898|NCT01162135|O1|Outcome|Digoxin|Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
333899|NCT01162135|E1|Reported Event|Digoxin|Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
333900|NCT01162122|B3|Baseline|Total|Total of all reporting groups
333901|NCT01162122|B2|Baseline|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333902|NCT01162122|B1|Baseline|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333903|NCT01162122|P2|Participant Flow|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333904|NCT01162122|P1|Participant Flow|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333905|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333906|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333907|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333908|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333909|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333910|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333911|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333912|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333913|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333914|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333915|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333916|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333917|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333918|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333919|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333920|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333921|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333922|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333923|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333924|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333925|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333926|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333927|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333928|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333929|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333930|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333931|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333932|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333933|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333934|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333935|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333938|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333939|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333940|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333941|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333942|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333943|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333944|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333945|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333946|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333947|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333948|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333949|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333950|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333951|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333952|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333953|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333954|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333955|NCT01162122|O3|Outcome|aTIV_Lot 3|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
333956|NCT01162122|O2|Outcome|aTIV_Lot 2|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
333957|NCT01162122|O1|Outcome|aTIV_Lot 1|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
333958|NCT01162122|E2|Reported Event|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
333959|NCT01162122|E1|Reported Event|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
333960|NCT01162096|B1|Baseline|Transplantation|
333961|NCT01162096|P1|Participant Flow|Transplantation|
333962|NCT01162096|O1|Outcome|Transplantation|Haploidentical Allogeneic Transplantation: Patients undergoing reduced intensity haploidentical hematopoietic stem cell transplant from a partially matched related donor.
333963|NCT01162096|O1|Outcome|Transplantation|Haploidentical Allogeneic Transplantation: Patients undergoing reduced intensity haploidentical hematopoietic stem cell transplant from a partially matched related donor.
333964|NCT01162096|O1|Outcome|Transplantation|
333965|NCT01162096|E1|Reported Event|Transplantation|
333966|NCT01161862|B3|Baseline|Total|Total of all reporting groups
333967|NCT01161862|B2|Baseline|Bi-hormonal Pancreas Without Meal-priming Bolus|The insulin controller was entirely reactive to CGMG; there were no meal priming boluses and no meal announcements
333968|NCT01161862|B1|Baseline|Bi-hormonal Pancreas With Meal-priming Bolus|An automatically adapting meal priming bolus was given by the controller at the time each meal was presented
333969|NCT01161862|P2|Participant Flow|Bi-hormonal Bionic Pancreas With no Meal-priming Bolus|Bi-hormonal bionic pancreas with no meal-priming bolus. The controller was entirely reactive to CGMG; there were no meal priming boluses and no meal announcements
333970|NCT01161862|P1|Participant Flow|Bi-hormonal Bionic Pancreas With Meal-priming Bolus|The first meal-priming bolus was solely based on weight (0.05 U/kg), after which meal-priming boluses were automatically adapted by the control system online targeting 75% of the anticipated insulin needed in the first four hours after the start of the meal.
333971|NCT01161862|O2|Outcome|Bionic Pancreas Without Automated Meal-priming Bolus|"Bi-hormonal bionic pancreas~Bi-hormonal (insulin and glucagon) artificial pancreas"
333972|NCT01161862|O1|Outcome|Bionic Pancreas With Automated Meal-priming Bolus|"Bi-hormonal bionic pancreas~Bi-hormonal (insulin and glucagon) artificial pancreas"
333973|NCT01161862|O2|Outcome|Bi-hormonal Without Meal Priming Bolus|
333974|NCT01161862|O1|Outcome|Bi-hormonal With Meal Priming Bolus|"Bi-hormonal bionic pancreas~Bi-hormonal (insulin and glucagon) artificial pancreas"
333975|NCT01161862|O2|Outcome|Bi-hormonal Without Meal Priming Bolus|
333976|NCT01161862|O1|Outcome|Bi-hormonal With Meal Priming Bolus|"Bi-hormonal bionic pancreas~Bi-hormonal (insulin and glucagon) artificial pancreas"
333977|NCT01161862|O2|Outcome|Bionic Pancreas Without Automated Meal-priming Bolus|
333978|NCT01161862|O1|Outcome|Bionic Pancreas With Automated Meal-priming Bolus|"Bi-hormonal bionic pancreas~Bi-hormonal (insulin and glucagon) artificial pancreas"
333979|NCT01161862|O2|Outcome|Bionic Pancreas Without Automated Meal-priming Bolus|
333980|NCT01161862|O1|Outcome|Bionic Pancreas With Automated Meal-priming Bolus|"Bi-hormonal bionic pancreas~Bi-hormonal (insulin and glucagon) artificial pancreas"
333981|NCT01161862|O2|Outcome|Bionic Pancreas Without Automated Meal-priming Bolus|
333982|NCT01161862|O1|Outcome|Bionic Pancreas With Automated Meal-priming Bolus|"Bi-hormonal bionic pancreas~Bi-hormonal (insulin and glucagon) artificial pancreas"
333984|NCT01161862|O1|Outcome|Bionic Pancreas With Automated Meal-priming Bolus|"Bi-hormonal bionic pancreas~Bi-hormonal (insulin and glucagon) artificial pancreas"
333985|NCT01161862|O2|Outcome|Bionic Pancreas Without Automated Meal-priming Bolus|
333986|NCT01161862|O1|Outcome|Bionic Pancreas With Automated Meal-priming Bolus|"Bi-hormonal bionic pancreas~Bi-hormonal (insulin and glucagon) artificial pancreas"
333987|NCT01161862|E2|Reported Event|Bi-hormonal Without Meal Priming Bolus|Bi-hormonal with no meal announcements or meal priming boluses
333988|NCT01161862|E1|Reported Event|Bi-hormonal With Meal Priming Bolus|Bi-hormonal with adaptive meal priming bolus
333989|NCT01161771|B1|Baseline|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
333990|NCT01161771|P1|Participant Flow|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
333991|NCT01161771|O1|Outcome|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
333992|NCT01161771|O1|Outcome|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
333993|NCT01161771|O1|Outcome|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
333994|NCT01161771|O1|Outcome|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
333995|NCT01161771|O1|Outcome|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
333996|NCT01161771|O1|Outcome|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
333997|NCT01161771|E1|Reported Event|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
333998|NCT01161628|B1|Baseline|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
333999|NCT01161628|P1|Participant Flow|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
334000|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
334001|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
334002|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
334003|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
334004|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
334005|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
334006|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
334007|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
334008|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
334009|NCT01161628|E1|Reported Event|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
334010|NCT01161563|B3|Baseline|Total|Total of all reporting groups
334011|NCT01161563|B2|Baseline|Triptorelin First, Then Leuprolide Acetate|Triptorelin pamoate suspension (Trelstar 22.5 mg) injected intramuscularly in the buttock 6 months before injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) subcutaneously in upper or mid-abdominal area.
334012|NCT01161563|B1|Baseline|Leuprolide Acetate First, Then Triptorelin|Polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) injected subcutaneously in upper or mid-abdominal area 6 months before injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock.
334013|NCT01161563|P2|Participant Flow|Leuprolide Acetate First, Then Triptorelin|"Injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) in the upper or mid-abdominal area, followed 6 months later by injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock.~A detailed breakdown of participant flow by treatment period for each arm is not available."
334014|NCT01161563|P1|Participant Flow|Triptorelin First, Then Leuprolide Acetate|"Injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock, followed 6 months later by injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) in the upper or mid-abdominal area.~A detailed breakdown of participant flow by treatment period for each arm is not available."
334334|NCT01160822|P7|Participant Flow|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
334015|NCT01161563|O2|Outcome|Triptorelin Pamoate|Results combined for the triptorelin pamoate treatment period for both randomization groups for the Per-protocol population (n=107), defined as all patients who receive both study drugs and complete both post-injection questionnaires.
334016|NCT01161563|O1|Outcome|Leuprolide Acetate|Results combined for the leuprolide acetate treatment period for both randomization groups for the Per-protocol population (n=107), defined as all patients who receive both study drugs and complete both post-injection questionnaires.
334017|NCT01161563|O2|Outcome|Triptorelin Pamoate|Results combined for the triptorelin pamoate treatment period for both randomization groups for the Per-protocol population (n=107), defined as all patients who receive both study drugs and complete both post-injection questionnaires.
334018|NCT01161563|O1|Outcome|Leuprolide Acetate|Results combined for the leuprolide acetate treatment period for both randomization groups for the Per-protocol population (n=107), defined as all patients who receive both study drugs and complete both post-injection questionnaires.
334019|NCT01161563|E2|Reported Event|Triptorelin Pamoate|
334020|NCT01161563|E1|Reported Event|Leuprolide Acetate|
334021|NCT01161537|B1|Baseline|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
334022|NCT01161537|P1|Participant Flow|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 milligram (mg) orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
334023|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
334024|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
334025|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
334026|NCT01161537|O1|Outcome|Part B VX-770 Treatment|Subjects who received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study were assessed between Day 1 to Week 48 of Part B. Part B included subjects from Part A and newly enrolled subjects.
334027|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
334028|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
334029|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
334030|NCT01161537|O2|Outcome|Part A VX-770 Treatment|Subjects who received VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), during Part A of the study were assessed between Day 15 to 42 of Part A.
334031|NCT01161537|O1|Outcome|Part A Placebo Run in/Washout|Subjects who received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period) and from Day 43 to 57 (Placebo washout period) during Part A of the study were assessed between Day 1 to 14 and Day 43 to 57 of Part A.
334032|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
334335|NCT01160822|P6|Participant Flow|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334033|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
334034|NCT01161537|E3|Reported Event|Part B VX-770 Treatment|Subjects who received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study were assessed between Day 1 to Week 48 of Part B. Part B included subjects from Part A and newly enrolled subjects.
334035|NCT01161537|E2|Reported Event|Part A VX-770 Treatment|Subjects who received VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), during Part A of the study were assessed between Day 15 to 42 of Part A.
334036|NCT01161537|E1|Reported Event|Part A Placebo Run in/Washout|Subjects who received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period) and from Day 43 to 57 (Placebo washout period) during Part A of the study were assessed between Day 1 to 14 and Day 43 to 57 of Part A.
334037|NCT01161498|B3|Baseline|Total|Total of all reporting groups
334038|NCT01161498|B2|Baseline|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
334039|NCT01161498|B1|Baseline|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
334040|NCT01161498|P2|Participant Flow|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ plaque-forming units (PFU)/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
334041|NCT01161498|P1|Participant Flow|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
334042|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
334043|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
334044|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
334045|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
334046|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
334047|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
334048|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
334049|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
334050|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
334051|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
334052|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
334053|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
334054|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
334055|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
334056|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
334057|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
334058|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
334059|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
334060|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
334061|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
334062|NCT01161498|E2|Reported Event|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
334063|NCT01161498|E1|Reported Event|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
334064|NCT01161472|B1|Baseline|Entire Study Population|All participants randomized to any treatment (fesoterodine 4 mg tablet first, fesoterodine 8 mg tablet first, alprazolam 1 mg capsule first and placebo first).
334065|NCT01161472|P4|Participant Flow|Placebo, Aplrazolam 1 mg, Fesoterodine 4 mg, Fesoterodine 8 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; followed by placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; then fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.
334066|NCT01161472|P3|Participant Flow|Aplrazolam 1 mg, Fesoterodine 8 mg, Placebo, Fesoterodine 4 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; followed by fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; then placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.
334067|NCT01161472|P2|Participant Flow|Fesoterodine 8 mg, Fesoterodine 4 mg, Aplrazolam 1 mg, Placebo|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; then fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; followed by placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.
334094|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334068|NCT01161472|P1|Participant Flow|Fesoterodine 4 mg, Placebo, Fesoterodine 8 mg, Aplrazolam 1 mg|Fesoterodine 4 milligram (mg) tablet administered orally once daily (OD) for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; followed by placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; then fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.
334069|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334070|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334071|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334072|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334073|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334074|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334075|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334076|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334077|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334078|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334079|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334080|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334081|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334082|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334083|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334084|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334085|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334086|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334087|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334088|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334089|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334090|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334091|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334092|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334093|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334095|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334096|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334097|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334098|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334099|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334100|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334101|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334102|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334103|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334104|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334105|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334106|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334107|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334108|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334109|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334110|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334111|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334112|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334113|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334114|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334115|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334116|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334117|NCT01161472|E4|Reported Event|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334118|NCT01161472|E3|Reported Event|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334119|NCT01161472|E2|Reported Event|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334120|NCT01161472|E1|Reported Event|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
334121|NCT01161446|B3|Baseline|Total|Total of all reporting groups
334122|NCT01161446|B2|Baseline|Standard Testing|HIV testing as usual.
334123|NCT01161446|B1|Baseline|Home Testing|Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
334125|NCT01161446|P1|Participant Flow|Home Testing|Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
334126|NCT01161446|O2|Outcome|Standard Testing|HIV testing as usual.
334127|NCT01161446|O1|Outcome|Home Testing|Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
334128|NCT01161446|O2|Outcome|Standard Testing|HIV testing as usual.
334129|NCT01161446|O1|Outcome|Home Testing|Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
334130|NCT01161446|O2|Outcome|Standard Testing|HIV testing as usual.
334131|NCT01161446|O1|Outcome|Home Testing|Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
334132|NCT01161446|O2|Outcome|Standard Testing|HIV testing as usual.
334133|NCT01161446|O1|Outcome|Home Testing|Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
334134|NCT01161446|E2|Reported Event|Standard Testing|HIV testing as usual.
334135|NCT01161446|E1|Reported Event|Home Testing|"Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.~Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: The device is the home HIV self-testing kit that includes the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use on oral fluids. The kit itself is not the focus of this trial. As described in the Behavioral Intervention section, the intervention is having access to home self-testing for HIV."
334136|NCT01161420|B1|Baseline|Inspire Therapy|"Study subjects continue to use Inspire therapy~Inspire Upper Airway Stimulator: The stimulator is surgically positioned subcutaneously near the clavicle in the upper chest, and connects to a stimulation lead (around a hypoglossal nerve) and a sensing lead (in the chest). The stimulation contracts a patient's upper airway muscles to maintain airway patency, with the intent to keep the airway open during inspiration."
334137|NCT01161420|P1|Participant Flow|Inspire Therapy|126 subjects were implanted with Inspire therapy
334138|NCT01161420|O1|Outcome|Inspire Therapy|126 subjects were implanted with Inspire therapy; 124 subjects completed this visit (two expired prior to the 12-month visit).
334139|NCT01161420|O1|Outcome|Inspire Therapy|126 subjects completed the baseline questionnaire, however 123 study subjects completed the 12-month questionnaire; two subjects did not completed this questionnaire and one subject expired.
334140|NCT01161420|O1|Outcome|Inspire Therapy|126 subjects completed the baseline questionnaire, however 123 study subjects completed the 12-month questionnaire; two subjects did not completed this questionnaire and one subject expired.
334141|NCT01161420|O1|Outcome|Inspire Therapy|126 subjects implanted with Inspire therapy
334142|NCT01161420|O2|Outcome|Withdrawal|Twenty-three (23) patients were in the therapy withdrawal (OFF) group.
334143|NCT01161420|O1|Outcome|Maintenance|Twenty-three (23) patients were in the therapy maintenance (ON) group
334144|NCT01161420|O1|Outcome|All Subjects|126 implanted study subjects
334145|NCT01161420|O1|Outcome|Inspire Therapy|Study subjects continue to use Inspire therapy; Inspire Upper Airway Stimulator: The stimulator is surgically positioned subcutaneously near the clavicle in the upper chest, and connects to a stimulation lead (around a hypoglossal nerve) and a sensing lead (in the chest). The stimulation contracts a patient's upper airway muscles to maintain airway patency, with the intent to keep the airway open during inspiration.
334146|NCT01161420|O1|Outcome|Inspire Therapy|Study subjects continue to use Inspire therapy; Inspire Upper Airway Stimulator: The stimulator is surgically positioned subcutaneously near the clavicle in the upper chest, and connects to a stimulation lead (around a hypoglossal nerve) and a sensing lead (in the chest). The stimulation contracts a patient's upper airway muscles to maintain airway patency, with the intent to keep the airway open during inspiration.
334147|NCT01161420|E1|Reported Event|Inspire Therapy|This pivotal trial was to evaluate safety via a description of all reported adverse events. Per the IDE-approved protocol, no formal statistical hypothesis was tested as part of the safety assessment.
334148|NCT01161407|B3|Baseline|Total|Total of all reporting groups
334149|NCT01161407|B2|Baseline|Placebo Then Calcium|"Crossover order was placebo then calcium, separated by at least a 3 week washout period.~Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration."
334150|NCT01161407|B1|Baseline|Calcium Then Placebo|"Crossover order was calcium then placebo, separated by at least a 3 week washout period.~Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration."
334151|NCT01161407|P2|Participant Flow|Placebo Then Calcium|"Crossover order was placebo then calcium, separated by at least a 3 week washout period.~Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration."
337410|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
334152|NCT01161407|P1|Participant Flow|Calcium Then Placebo|"Crossover order was calcium then placebo, separated by at least a 3 week washout period.~Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration."
334153|NCT01161407|O2|Outcome|Calcium|
334154|NCT01161407|O1|Outcome|Placebo|
334155|NCT01161407|O2|Outcome|Calcium|
334156|NCT01161407|O1|Outcome|Placebo|
334157|NCT01161407|O2|Outcome|Calcium|
334158|NCT01161407|O1|Outcome|Placebo|
334159|NCT01161407|E2|Reported Event|Calcium|
334160|NCT01161407|E1|Reported Event|Placebo|
334161|NCT01161329|B3|Baseline|Total|Total of all reporting groups
334162|NCT01161329|B2|Baseline|Intervention Group|High Intensity Functional Exercise Program
334163|NCT01161329|B1|Baseline|Controlgroup|Ordinary life.
334164|NCT01161329|P2|Participant Flow|Intervention Group|High-Intensity Functional Exercise Program (HIFE) in combination with motivational group discussions two times a week. .
334165|NCT01161329|P1|Participant Flow|Controlgroup|Instructed to live their ordinary life.
334166|NCT01161329|O2|Outcome|Group Exercise Program|High-Intensity Functional Exercise Program
334167|NCT01161329|O1|Outcome|Controlgroup|Ordinary life.
334168|NCT01161329|O2|Outcome|Intervention Group|High Intensity Functional Exercise Program
334169|NCT01161329|O1|Outcome|Controlgroup|Ordinary life.
334170|NCT01161329|E2|Reported Event|Intervention Group|High Intensity Functional Exercise Program
334171|NCT01161329|E1|Reported Event|Controlgroup|Ordinary life.
334172|NCT01161225|B4|Baseline|Total|Total of all reporting groups
334173|NCT01161225|B3|Baseline|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334174|NCT01161225|B2|Baseline|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334175|NCT01161225|B1|Baseline|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334176|NCT01161225|P3|Participant Flow|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334177|NCT01161225|P2|Participant Flow|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334178|NCT01161225|P1|Participant Flow|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334179|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334180|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334181|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334182|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders
334183|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program
343103|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
334185|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334186|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334187|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334188|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334189|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334190|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334191|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334192|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334193|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334194|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334195|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334196|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334197|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334540|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 10 mg ORF
334198|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334199|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months
334200|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334201|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334202|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334203|NCT01161225|E3|Reported Event|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334204|NCT01161225|E2|Reported Event|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334205|NCT01161225|E1|Reported Event|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
334206|NCT01161173|B1|Baseline|Cohort|Participants in the observational cohort received second-line therapy with Tarceva. At the time of discontinuation of Tarceva, a third-line chemotherapy or best supportive care were initiated as appropriate.
334207|NCT01161173|P1|Participant Flow|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
334208|NCT01161173|O1|Outcome|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
334209|NCT01161173|O1|Outcome|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
334210|NCT01161173|O1|Outcome|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
334211|NCT01161173|O1|Outcome|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
334212|NCT01161173|O1|Outcome|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
334213|NCT01161173|O1|Outcome|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
334214|NCT01161173|E1|Reported Event|Erlotinib|"Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.~Erlotinib: Erlotinib was provided in the retail versions of the product."
334215|NCT01161160|B4|Baseline|Total|Total of all reporting groups
334216|NCT01161160|B3|Baseline|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334541|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years received a single dose of 20 mg ORF
334217|NCT01161160|B2|Baseline|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334218|NCT01161160|B1|Baseline|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334219|NCT01161160|P3|Participant Flow|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334220|NCT01161160|P2|Participant Flow|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334221|NCT01161160|P1|Participant Flow|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334222|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334223|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334224|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334225|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334226|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334227|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334228|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334229|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334230|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334231|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334232|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334233|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334234|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334235|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334236|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334237|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334238|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334239|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334240|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334241|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334542|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years received a single dose of 15 mg ORF
334242|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334243|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334244|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334245|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334246|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334247|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334248|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334249|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334250|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334251|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334252|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334253|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334254|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334255|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334256|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334257|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334258|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334259|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334260|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334261|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334262|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334263|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334264|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334265|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334266|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334543|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years received a single dose of 10 mg ORF
334267|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334268|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334269|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334270|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334271|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334272|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334273|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334274|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334275|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334276|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334277|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334278|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334279|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334280|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334281|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334282|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334283|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334284|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334285|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334286|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334287|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334288|NCT01161160|E3|Reported Event|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334289|NCT01161160|E2|Reported Event|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334290|NCT01161160|E1|Reported Event|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
334291|NCT01161121|B1|Baseline|Adenosine, Regadenoson|Each patient underwent standard intravenous adenosine infusion (140mcg/kg/min) with invasive pressure recordings for 2 min, or until maximal hyperemia occurred. Five minutes after return to baseline hemodynamics, a single intravenous bolus of 0.4 mg regadenoson was administered, and pressures were recorded for 5 min. FFR values were compared by linear regression and Bland-Altman analysis.
334292|NCT01161121|P1|Participant Flow|Adenosine Then Regadenoson|"Adenosine infusion will be compared to Regadenoson for efficacy and safety/side effects. Arterial blood pressure, coronary pressure, heart rate, oxygen saturation and coronary flow, FFR, and coronary flow velocity will be assessed. Safety will be assessed by monitoring for any side effects such as chest pain, headache, flushing, nausea, or arrhythmias. All patients to receive Adenosine infusion followed by Regadenoson IV bolus upon return of coronary flow velocity to 15% of pre-dose value.~Adenosine : Injection of IV Adenosine for 2 minutes at rate of 140mcg/kg to dilate coronary arteries and provoke maximal hyperemia.~Regadenoson : Administration of IV regadenoson bolus 0.4 mg/5 mls over 10 seconds followed by a 5 cc NS saline flush"
334293|NCT01161121|O2|Outcome|Regadenoson|"Once the mean coronary flow velocity returns to within 15% pre-dose value following IV infusion of Adenosine, Regadenoson IV injection will be given at 0.4 mg 5/ml- 0.08mg/ml over 10 seconds followed by a 5 cc IV saline flush.~regadenoson : Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds."
334294|NCT01161121|O1|Outcome|Adenosine|"Adenosine infusion will be compared to Regadenoson for safety/side effects. Arterial blood pressure, coronary pressure, heart rate, oxygen saturation and coronary flow, FFR, and coronary flow velocity will be assessed. Safety will be assessed by monitoring for any side effects such as chest pain, headache, flushing, nausea, or arrhythmias.~Adenosine : Injection of IV Adenosine for 2 minutes at rate of 140mcg/kg to dilate coronary arteries and provoke maximal hyperemia"
334295|NCT01161121|O2|Outcome|Regadenosine|With bolus infusion of 0.4 mg
334296|NCT01161121|O1|Outcome|Adenosine|With infusion of 140 mcg/kg/min
334297|NCT01161121|O2|Outcome|Regadenoson|"Once the mean coronary flow velocity returns to within 15% pre-dose value following IV infusion of Adenosine, Regadenoson IV injection will be given at 0.4 mg 5/ml- 0.08mg/ml over 10 seconds followed by a 5 cc IV saline flush.~regadenoson : Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds."
334298|NCT01161121|O1|Outcome|Adenosine|"Adenosine infusion will be compared to Regadenoson for safety/side effects. Arterial blood pressure, coronary pressure, heart rate, oxygen saturation and coronary flow, FFR, and coronary flow velocity will be assessed. Safety will be assessed by monitoring for any side effects such as chest pain, headache, flushing, nausea, or arrhythmias.~Adenosine : Injection of IV Adenosine for 2 minutes at rate of 140mcg/kg to dilate coronary arteries and provoke maximal hyperemia"
334299|NCT01161121|E2|Reported Event|Regadenoson|"Once the mean coronary flow velocity returns to within 15% pre-dose value then Regadenoson IV injection will be given at 0.4 mg 5/ml- 0.08mg/ml. Then, a 5 cc saline flush will be administered.~regadenoson : Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds."
334300|NCT01161121|E1|Reported Event|Adenosine|"Adenosine infusion will be compared to Regadenoson for safety/side effects. Arterial blood pressure, coronary pressure, heart rate, oxygen saturation and coronary flow, FFR, and coronary flow velocity will be assessed. Safety will be assessed by monitoring for any side effects such as chest pain, headache, flushing, nausea, or arrhythmias.~Adenosine : Injection of IV Adenosine for 2 minutes at rate of 140mcg/kg to dilate coronary arteries and provoke maximal hyperemia~adenosine : Measuring FFR and Coronary Flow Reserve after administration of IV adenosine 140 mcg/kg/min for 2 minutes.~regadenoson : Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds."
334301|NCT01160848|B3|Baseline|Total|Total of all reporting groups
334302|NCT01160848|B2|Baseline|3 Areas Per Patient, 24 Hours|
334303|NCT01160848|B1|Baseline|3 Areas Per Patient, 3 Hours|
334304|NCT01160848|P2|Participant Flow|3 Areas Per Patient, 24 Hours|Group 1: Visonac left on skin for 1 hour Group 2: Visonac left on skin for 24 hours, area 1 Group 3: Visonac left on skin for 24 hours, area 2
334305|NCT01160848|P1|Participant Flow|3 Areas Per Patient, 3 Hours|Visonac : MAL 80 mg/g Group 1: Alcohol wipe and Visonac without occlusion Group 2: Saline wipe and Visonac with occlusion Group 3: Saline wipe and Visonac without occlusion
334306|NCT01160848|O3|Outcome|Visonac Left on Skin for 24 Hours in Area 2|
334307|NCT01160848|O2|Outcome|Visonac Left on Skin for 24 Hours in Area 1|
334308|NCT01160848|O1|Outcome|Visonac Wiped Off After 1 Hour|
334309|NCT01160848|O3|Outcome|Visonac Left on Skin for 24 Hours in Area 2|
334310|NCT01160848|O2|Outcome|Visonac Left on Skin for 24 Hours in Area 1|
334311|NCT01160848|O1|Outcome|Visonac Wiped Off After 1 Hour|
334312|NCT01160848|O3|Outcome|Visonac Left on Skin for 24 Hours in Area 2|
334313|NCT01160848|O2|Outcome|Visonac Left on Skin for 24 Hours in Area 1|
334314|NCT01160848|O1|Outcome|Visonac Wiped Off After 1 Hour|
334315|NCT01160848|O3|Outcome|Visonac Left on Skin for 24 Hours in Area 2|
334316|NCT01160848|O2|Outcome|Visonac Left on Skin for 24 Hours in Area 1|
334317|NCT01160848|O1|Outcome|Visonac Wiped Off After 1 Hour|
334318|NCT01160848|O3|Outcome|Area Cleaned With Ethyl Alcohol Solution|
334319|NCT01160848|O2|Outcome|Area Cleaned With Saline|
334320|NCT01160848|O1|Outcome|Part 1: Area Cleaned With Saline and Occluded With Tegaderm|
334321|NCT01160848|O3|Outcome|Area Cleaned With Ethyl Alcohol Solution|
334322|NCT01160848|O2|Outcome|Area Cleaned With Saline|
334323|NCT01160848|O1|Outcome|Part 1: Area Cleaned With Saline and Occluded With Tegaderm|
334324|NCT01160848|E2|Reported Event|3 Areas Per Patient, 24 Hours|
334325|NCT01160848|E1|Reported Event|3 Areas Per Patient, 3 Hours|
334326|NCT01160822|B8|Baseline|Total|Total of all reporting groups
334327|NCT01160822|B7|Baseline|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
334328|NCT01160822|B6|Baseline|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334329|NCT01160822|B5|Baseline|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334330|NCT01160822|B4|Baseline|Part A: Placebo|Participants received a single intra-articular injection of canakinumab-matching placebo.
334331|NCT01160822|B3|Baseline|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
334336|NCT01160822|P5|Participant Flow|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334337|NCT01160822|P4|Participant Flow|Part A: Placebo|Participants received a single intra-articular injection of canakinumab-matching placebo.
334338|NCT01160822|P3|Participant Flow|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
334339|NCT01160822|P2|Participant Flow|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
334340|NCT01160822|P1|Participant Flow|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
334341|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334342|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
334343|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
334344|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
334345|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334346|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
334347|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
334348|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
334349|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334350|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
334351|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
334352|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
334353|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334354|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
334355|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
334356|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
334357|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334358|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
334359|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
334360|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
334361|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334362|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
334363|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
334364|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
334365|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334366|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
334367|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
334368|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
334369|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
334370|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334371|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334372|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
334373|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334374|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334375|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
334376|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
337411|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
334377|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334378|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
334379|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334380|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334381|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
334382|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334383|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334384|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
334385|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334386|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334387|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
334388|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334389|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334390|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
334391|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334392|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334393|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
334394|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334395|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334396|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
334397|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334398|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334399|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
334400|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334401|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334402|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
334403|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334404|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334405|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
334406|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334407|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334408|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
334409|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334786|NCT01159665|O3|Outcome|PPV 2-4 Hours After Injection|Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
334410|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334411|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
334412|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334413|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334414|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
334415|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334416|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334417|NCT01160822|O4|Outcome|Part A: Placebo|Participants received a single intra-articular injection of canakinumab-matching placebo.
334418|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
334419|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
334420|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
334421|NCT01160822|E7|Reported Event|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
334422|NCT01160822|E6|Reported Event|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334423|NCT01160822|E5|Reported Event|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
334424|NCT01160822|E4|Reported Event|Part A: Placebo|Participants received a single intra-articular injection of canakinumab-matching placebo.
334425|NCT01160822|E3|Reported Event|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
334426|NCT01160822|E2|Reported Event|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
334427|NCT01160822|E1|Reported Event|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
334428|NCT01160770|B1|Baseline|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
334429|NCT01160770|P1|Participant Flow|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
334430|NCT01160770|O1|Outcome|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
334431|NCT01160770|O1|Outcome|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
334432|NCT01160770|O1|Outcome|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
334433|NCT01160770|O1|Outcome|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
334434|NCT01160770|O1|Outcome|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
334435|NCT01160770|O1|Outcome|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
334436|NCT01160770|E1|Reported Event|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
334437|NCT01160744|B5|Baseline|Total|Total of all reporting groups
334438|NCT01160744|B4|Baseline|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334439|NCT01160744|B3|Baseline|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334440|NCT01160744|B2|Baseline|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334441|NCT01160744|B1|Baseline|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334442|NCT01160744|P4|Participant Flow|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of each every 21-day cycle. Participants were treated for up to 89 weeks.
334443|NCT01160744|P3|Participant Flow|Gem + Carb or Cis (Squamous)|"Gemcitabine (Gem): 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb [Area Under the Concentration Time Curve 5 (AUC 5)]: Day 1 of every 21-day cycle.~Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks."
334444|NCT01160744|P2|Participant Flow|Ram + Pem + Carb or Cis (Non-Squamous)|Ramucirumab (Ram): 10 milligrams/kilogram (mg/kg) Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334470|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334445|NCT01160744|P1|Participant Flow|Pem + Carb or Cis (Non-Squamous)|"Pemetrexed (Pem): 500 milligrams/square meter (mg/m²) on Day 1 of every 21-day cycle.~Carboplatin (Carb) [Area Under the Concentration Time Curve 6 (AUC 6)] : Day 1 of every 21-day cycle.~Cisplatin (Cis): 75 mg/m² intravenous (IV) on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks."
334446|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334447|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334448|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cisplatin: 75 mg/m² IV on Day 1 of each 21-day cycle. Participants were treated for up to 89 weeks.
334449|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334450|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334451|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334452|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cisplatin: 75 mg/m² IV on Day 1 of each 21-day cycle. Participants were treated for up to 89 weeks.
334453|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334454|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334455|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334456|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334457|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334458|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334459|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334460|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334461|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334462|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334463|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334464|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334465|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334466|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334467|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334468|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334469|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334538|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
334471|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334472|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334473|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334474|NCT01160744|E4|Reported Event|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334475|NCT01160744|E3|Reported Event|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334476|NCT01160744|E2|Reported Event|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334477|NCT01160744|E1|Reported Event|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
334478|NCT01160640|B3|Baseline|Total|Total of all reporting groups
334479|NCT01160640|B2|Baseline|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days~ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
334480|NCT01160640|B1|Baseline|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days~ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
334481|NCT01160640|P2|Participant Flow|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days~ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
334482|NCT01160640|P1|Participant Flow|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days~ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
334483|NCT01160640|O2|Outcome|Histological Endometritis Absent|Women who did not have endometritis confirmed by histologic assessment for endometritis
334484|NCT01160640|O1|Outcome|Histological Endometritis Present|Women who had endometritis confirmed by histologic assessment for endometritis. Endometritis was defined as >1 plasma cell per 100X microscopic field, was assessed independently by 2 pathologists blinded to the design
334485|NCT01160640|O2|Outcome|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days~ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
334486|NCT01160640|O1|Outcome|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days~ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
334487|NCT01160640|O2|Outcome|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days~ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
334488|NCT01160640|O1|Outcome|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days~ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
334489|NCT01160640|O2|Outcome|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days~ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
334490|NCT01160640|O1|Outcome|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days~ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
334491|NCT01160640|O2|Outcome|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days~ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
334492|NCT01160640|O1|Outcome|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days~ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
334493|NCT01160640|E2|Reported Event|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days~ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
334494|NCT01160640|E1|Reported Event|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days~ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
334495|NCT01160614|B3|Baseline|Total|Total of all reporting groups
334539|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 15 mg ORF
334496|NCT01160614|B2|Baseline|≥ 12 to ≤ 16 Years|Children aged ≥ 12 to ≤ 16 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
334497|NCT01160614|B1|Baseline|6 to < 12 Years|Children aged 6 to < 12 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
334498|NCT01160614|P2|Participant Flow|≥ 12 to ≤ 16 Years|Children aged ≥ 12 to ≤ 16 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
334499|NCT01160614|P1|Participant Flow|6 to < 12 Years|Children aged 6 to < 12 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
334500|NCT01160614|O2|Outcome|≥ 12 to ≤ 16 Years|Children aged ≥ 12 to ≤ 16 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
334501|NCT01160614|O1|Outcome|6 to < 12 Years|Children aged 6 to < 12 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
334502|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
334503|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 15 mg ORF
334504|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 10 mg ORF
334505|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 20 mg ORF
334506|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 15 mg ORF
334507|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 10 mg ORF
334508|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
334509|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 15 mg ORF
334510|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 10 mg ORF
334511|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 20 mg ORF
334512|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 15 mg ORF
334513|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 10 mg ORF
334514|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
334515|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 15 mg ORF
334516|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 10 mg ORF
334517|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 20 mg ORF
334518|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 15 mg ORF
334519|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 10 mg ORF
334520|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
334521|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 15 mg ORF
334522|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 10 mg ORF
334523|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years received a single dose of 20 mg ORF
334524|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years received a single dose of 15 mg ORF
334525|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years received a single dose of 10 mg ORF
334526|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
334527|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 15 mg ORF
334528|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 10 mg ORF
334529|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years received a single dose of 20 mg ORF
334530|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years received a single dose of 15 mg ORF
334531|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years received a single dose of 10 mg ORF
334532|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years who received multiple doses of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
334533|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years who received multiple doses of 15 mg ORF
334534|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years who received multiple doses of 10 mg ORF
334535|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years who received multiple doses of 20 mg ORF
334536|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years who received multiple doses of 15 mg ORF
334537|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years who received multiple doses of 10 mg ORF
334544|NCT01160614|E2|Reported Event|≥ 12 to ≤ 16 Years|Children aged ≥ 12 to ≤ 16 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
334545|NCT01160614|E1|Reported Event|6 to < 12 Years|Children aged 6 to < 12 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
334546|NCT01160484|B1|Baseline|DVD-R Single Arm|"Dose schematic of Dexamethasone + Bortezomib + Pegylated Liposomal Doxorubicin + Lenalidomide (DVD-R) Therapy:~Per 28 Day Cycle, patients will received drug in the following order, dosing and schedule:~1) Dexamethasone- 40 mg intravenous infusion (IV) on Days 1, 4, 8 and 11; 2) Bortezomib- 1.0 mg/m2 infused over 3 to 5 seconds followed by a standard saline flush on Days 1, 4, 8 and 11; 3) Pegylated Liposomal Doxorubicin- 4.0 mg/m2 IV as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle; and 4) Lenalidomide- 10 mg PO on days 1-14"
334547|NCT01160484|P1|Participant Flow|DVD-R Single Arm|"Dose schematic of Dexamethasone + Bortezomib + Pegylated Liposomal Doxorubicin (PLD)+ Lenalidomide (DVD-R) Therapy:~Per 28 Day Cycle, patients will received drug in the following order, dosing and schedule:~1) Dexamethasone- 40 mg intravenous infusion (IV) on Days 1, 4, 8 and 11; 2) Bortezomib- 1.0 mg/m2 infused over 3 to 5 seconds followed by a standard saline flush on Days 1, 4, 8 and 11; 3) Pegylated Liposomal Doxorubicin- 4.0 mg/m2 IV as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle; and 4) Lenalidomide- 10 mg PO on days 1-14"
334548|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
334549|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
334550|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
334551|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
334552|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
334553|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
334554|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
334555|NCT01160484|E1|Reported Event|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
334556|NCT01160458|B1|Baseline|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
334557|NCT01160458|P1|Participant Flow|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
334558|NCT01160458|O1|Outcome|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
334559|NCT01160458|O1|Outcome|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
334560|NCT01160458|O1|Outcome|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
334561|NCT01160458|O1|Outcome|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
334562|NCT01160458|O1|Outcome|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
334563|NCT01160458|E1|Reported Event|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
334564|NCT01160445|B3|Baseline|Total|Total of all reporting groups
334565|NCT01160445|B2|Baseline|HD IL-2 + Zanolimumab - Renal Cell|"Patients with metastatic renal cancer~Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
334566|NCT01160445|B1|Baseline|HD IL-2 + Zanolimumab - Melanoma|"Patients with metastatic melanoma Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
334567|NCT01160445|P2|Participant Flow|HD IL-2 + Zanolimumab - Renal Cell|"Patients with metastatic renal cancer~Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
334568|NCT01160445|P1|Participant Flow|HD IL-2 + Zanolimumab - Melanoma|"Patients with metastatic melanoma~Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
334569|NCT01160445|O2|Outcome|HD IL-2 + Zanolimumab - Renal Cell|"Patients with metastatic renal cancer~Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
334570|NCT01160445|O1|Outcome|HD IL-2 + Zanolimumab - Melanoma|"Patients with metastatic melanoma Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
334571|NCT01160445|O2|Outcome|HD IL-2 + Zanolimumab - Renal Cell|"Patients with metastatic renal cancer~Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
334572|NCT01160445|O1|Outcome|HD IL-2 + Zanolimumab - Melanoma|"Patients with metastatic melanoma Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
334573|NCT01160445|E2|Reported Event|HD IL-2 + Zanolimumab - Renal Cell|"Patients with metastatic renal cancer~Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
334574|NCT01160445|E1|Reported Event|HD IL-2 + Zanolimumab - Melanoma|"Patients with metastatic melanoma Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
334575|NCT01160380|B3|Baseline|Total|Total of all reporting groups
334576|NCT01160380|B2|Baseline|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~armodafinil: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.~Placebo: Placebo taken at 150 mg daily. Taken orally as three 50 mg tablets."
334577|NCT01160380|B1|Baseline|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~armodafinil: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets."
334578|NCT01160380|P2|Participant Flow|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
334579|NCT01160380|P1|Participant Flow|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily."
334580|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
334581|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily."
334582|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
334583|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily."
334584|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
334585|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily."
334586|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
334587|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily."
334787|NCT01159665|O2|Outcome|PPV 31-60 Minutes After Injection|Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
334588|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
334589|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily."
334590|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
334591|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily."
334592|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
334593|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily."
334594|NCT01160380|E2|Reported Event|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.~AEs presented were those occurring during from Day 1 to Day 28 only"
334595|NCT01160380|E1|Reported Event|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily. All patients receiving armodafinil, including patients that crossover, were evaluated for adverse events (AEs) and serious adverse events (SAEs)."
334596|NCT01160237|B4|Baseline|Total|Total of all reporting groups
334597|NCT01160237|B3|Baseline|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
334598|NCT01160237|B2|Baseline|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
334599|NCT01160237|B1|Baseline|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
334600|NCT01160237|P3|Participant Flow|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
334601|NCT01160237|P2|Participant Flow|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
334602|NCT01160237|P1|Participant Flow|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
334603|NCT01160237|O3|Outcome|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
334604|NCT01160237|O2|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
334605|NCT01160237|O1|Outcome|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
334606|NCT01160237|O3|Outcome|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
334607|NCT01160237|O2|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
334608|NCT01160237|O1|Outcome|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
334609|NCT01160237|O3|Outcome|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
334610|NCT01160237|O2|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
334611|NCT01160237|O1|Outcome|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
334612|NCT01160237|O3|Outcome|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
334613|NCT01160237|O2|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
334614|NCT01160237|O1|Outcome|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
334615|NCT01160237|O3|Outcome|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
334616|NCT01160237|O2|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
334617|NCT01160237|O1|Outcome|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
334618|NCT01160237|O3|Outcome|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
334619|NCT01160237|O2|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
334620|NCT01160237|O1|Outcome|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
334621|NCT01160237|E3|Reported Event|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
334622|NCT01160237|E2|Reported Event|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
334623|NCT01160237|E1|Reported Event|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
334624|NCT01160198|B4|Baseline|Total|Total of all reporting groups
334625|NCT01160198|B3|Baseline|Ferrous Ascorbate 100 mg 1 Once-daily|Participants received ferrous ascorbate, 1 tablet of 100 mg once-daily after dinner, via oral route for 8 weeks.
334626|NCT01160198|B2|Baseline|Ferrous Bisglycinate Chelate 60 mg 1 Twice-daily|Participants received ferrous bisglycinate chelate, 1 tablet each of 60 mg, twice-daily after breakfast and dinner, via oral route for 8 weeks.
334627|NCT01160198|B1|Baseline|Ferrous Bisglycinate Chelate 60 mg 1 Once-daily|Participants received ferrous bisglycinate chelate, 1 tablet of 60 mg, once-daily after dinner, via oral route for 8 weeks.
334628|NCT01160198|P3|Participant Flow|Ferrous Ascorbate 100 mg 1 Once-daily|Participants received ferrous ascorbate, 1 tablet of 100 mg once-daily after dinner, via oral route for 8 weeks.
334629|NCT01160198|P2|Participant Flow|Ferrous Bisglycinate Chelate 60 mg 1 Twice-daily|Participants received ferrous bisglycinate chelate, 1 tablet each of 60 mg, twice-daily after breakfast and dinner, via oral route for 8 weeks.
334630|NCT01160198|P1|Participant Flow|Ferrous Bisglycinate Chelate 60 mg 1 Once-daily|Participants received ferrous bisglycinate chelate, 1 tablet of 60 mg, once-daily after dinner, via oral route for 8 weeks.
334631|NCT01160198|O3|Outcome|Ferrous Ascorbate 100 mg 1 Once-daily|Participants received ferrous ascorbate, 1 tablet of 100 mg once-daily after dinner, via oral route for 8 weeks.
334632|NCT01160198|O2|Outcome|Ferrous Bisglycinate Chelate 60 mg 1 Twice-daily|Participants received ferrous bisglycinate chelate, 1 tablet each of 60 mg, twice-daily after breakfast and dinner, via oral route for 8 weeks.
334633|NCT01160198|O1|Outcome|Ferrous Bisglycinate Chelate 60 mg 1 Once-daily|Participants received ferrous bisglycinate chelate, 1 tablet of 60 mg, once-daily after dinner, via oral route for 8 weeks.
334634|NCT01160198|O3|Outcome|Ferrous Ascorbate 100 mg 1 Once-daily|Participants received ferrous ascorbate, 1 tablet of 100 mg once-daily after dinner, via oral route for 8 weeks.
334635|NCT01160198|O2|Outcome|Ferrous Bisglycinate Chelate 60 mg 1 Twice-daily|Participants received ferrous bisglycinate chelate, 1 tablet each of 60 mg, twice-daily after breakfast and dinner, via oral route for 8 weeks.
334636|NCT01160198|O1|Outcome|Ferrous Bisglycinate Chelate 60 mg 1 Once-daily|Participants received ferrous bisglycinate chelate, 1 tablet of 60 mg, once-daily after dinner, via oral route for 8 weeks.
334637|NCT01160198|O3|Outcome|Ferrous Ascorbate 100 mg 1 Once-daily|Participants received ferrous ascorbate, 1 tablet of 100 mg once-daily after dinner, via oral route for 8 weeks.
334638|NCT01160198|O2|Outcome|Ferrous Bisglycinate Chelate 60 mg 1 Twice-daily|Participants received ferrous bisglycinate chelate, 1 tablet each of 60 mg, twice-daily after breakfast and dinner, via oral route for 8 weeks.
334639|NCT01160198|O1|Outcome|Ferrous Bisglycinate Chelate 60 mg 1 Once-daily|Participants received ferrous bisglycinate chelate, 1 tablet of 60 mg, once-daily after dinner, via oral route for 8 weeks.
334640|NCT01160198|O3|Outcome|Ferrous Ascorbate 100 mg 1 Once-daily|Participants received ferrous ascorbate, 1 tablet of 100 mg once-daily after dinner, via oral route for 8 weeks.
334641|NCT01160198|O2|Outcome|Ferrous Bisglycinate Chelate 60 mg 1 Twice-daily|Participants received ferrous bisglycinate chelate, 1 tablet each of 60 mg, twice-daily after breakfast and dinner, via oral route for 8 weeks.
334642|NCT01160198|O1|Outcome|Ferrous Bisglycinate Chelate 60 mg 1 Once-daily|Participants received ferrous bisglycinate chelate, 1 tablet of 60 mg, once-daily after dinner, via oral route for 8 weeks.
334643|NCT01160198|O2|Outcome|Ferrous Bisglycinate Chelate 60 mg 1 Twice-daily|Participants received ferrous bisglycinate chelate, 1 tablet each of 60 mg, twice-daily after breakfast and dinner, via oral route for 8 weeks.
334644|NCT01160198|O1|Outcome|Ferrous Bisglycinate Chelate 60 mg 1 Once-daily|Participants received ferrous bisglycinate chelate, 1 tablet of 60 mg, once-daily after dinner, via oral route for 8 weeks.
334645|NCT01160198|E3|Reported Event|Ferrous Ascorbate 100 mg 1 Once-daily|Participants received ferrous ascorbate, 1 tablet of 100 mg once-daily after dinner, via oral route for 8 weeks.
334646|NCT01160198|E2|Reported Event|Ferrous Bisglycinate Chelate 60 mg 1 Twice-daily|Participants received ferrous bisglycinate chelate, 1 tablet each of 60 mg, twice-daily after breakfast and dinner, via oral route for 8 weeks.
334647|NCT01160198|E1|Reported Event|Ferrous Bisglycinate Chelate 60 mg 1 Once-daily|Participants received ferrous bisglycinate chelate, 1 tablet of 60 mg, once-daily after dinner, via oral route for 8 weeks.
334648|NCT01159938|B4|Baseline|Total|Total of all reporting groups
334649|NCT01159938|B3|Baseline|T2DM With Normal UAER|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
334650|NCT01159938|B2|Baseline|T2DM With Albuminuria|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
334651|NCT01159938|B1|Baseline|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
334652|NCT01159938|P5|Participant Flow|T2DM With Normal UAER, Low to High|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334653|NCT01159938|P4|Participant Flow|T2DM With Normal UAER, High to Low|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334654|NCT01159938|P3|Participant Flow|T2DM With Albuminuria, Low to High|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334672|NCT01159938|O5|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334655|NCT01159938|P2|Participant Flow|T2DM With Albuminuria, High to Low|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334656|NCT01159938|P1|Participant Flow|Healthy Participants|Healthy participants with normal glucose tolerance and normal UAER did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
334657|NCT01159938|O5|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334658|NCT01159938|O4|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
334659|NCT01159938|O3|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334660|NCT01159938|O2|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
334661|NCT01159938|O1|Outcome|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
334662|NCT01159938|O5|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334663|NCT01159938|O4|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
334664|NCT01159938|O3|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334665|NCT01159938|O2|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
334666|NCT01159938|O1|Outcome|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams albumin per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
334667|NCT01159938|O5|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose
334668|NCT01159938|O4|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
334669|NCT01159938|O3|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334670|NCT01159938|O2|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
334671|NCT01159938|O1|Outcome|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
334673|NCT01159938|O4|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
334674|NCT01159938|O3|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334675|NCT01159938|O2|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
334676|NCT01159938|O1|Outcome|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
334677|NCT01159938|O5|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334678|NCT01159938|O4|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
334679|NCT01159938|O3|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334680|NCT01159938|O2|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
334681|NCT01159938|O1|Outcome|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
334682|NCT01159938|O6|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334683|NCT01159938|O5|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
334684|NCT01159938|O4|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334685|NCT01159938|O3|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
334686|NCT01159938|O2|Outcome|T2DM Overall (Low Postprandial Glucose)|T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334687|NCT01159938|O1|Outcome|T2DM Overall (High Postprandial Glucose)|T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
334688|NCT01159938|O6|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334689|NCT01159938|O5|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
334707|NCT01159938|O5|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
335044|NCT01158703|O2|Outcome|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
334690|NCT01159938|O4|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334691|NCT01159938|O3|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
334692|NCT01159938|O2|Outcome|T2DM Overall (Low Postprandial Glucose)|T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334693|NCT01159938|O1|Outcome|T2DM Overall (High Postprandial Glucose)|T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
334694|NCT01159938|O6|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334695|NCT01159938|O5|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
334696|NCT01159938|O4|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334697|NCT01159938|O3|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
334698|NCT01159938|O2|Outcome|T2DM Overall (Low Postprandial Glucose)|T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334699|NCT01159938|O1|Outcome|T2DM Overall (High Postprandial Glucose)|T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
334700|NCT01159938|O6|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334701|NCT01159938|O5|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
334702|NCT01159938|O4|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334703|NCT01159938|O3|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
334704|NCT01159938|O2|Outcome|T2DM Overall (Low Postprandial Glucose)|T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334705|NCT01159938|O1|Outcome|T2DM Overall (High Postprandial Glucose)|T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
334706|NCT01159938|O6|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
343104|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
334708|NCT01159938|O4|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334709|NCT01159938|O3|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
334710|NCT01159938|O2|Outcome|T2DM Overall (Low Postprandial Glucose)|T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
334711|NCT01159938|O1|Outcome|T2DM Overall (High Postprandial Glucose)|T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
334712|NCT01159938|E3|Reported Event|T2DM With Normal UAER|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
334713|NCT01159938|E2|Reported Event|T2DM With Albuminuria|T2DM participants with abnormal UAER [albuminuria(defined as urinary albumin)] but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
334714|NCT01159938|E1|Reported Event|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
334715|NCT01159912|B4|Baseline|Total|Total of all reporting groups
334716|NCT01159912|B3|Baseline|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334717|NCT01159912|B2|Baseline|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334718|NCT01159912|B1|Baseline|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334719|NCT01159912|P3|Participant Flow|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334720|NCT01159912|P2|Participant Flow|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334721|NCT01159912|P1|Participant Flow|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334722|NCT01159912|O3|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334723|NCT01159912|O2|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334724|NCT01159912|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334784|NCT01159665|O5|Outcome|PPV 7 Days (+1 Day) After Injection|Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
343105|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
334725|NCT01159912|O3|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334726|NCT01159912|O2|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334727|NCT01159912|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334728|NCT01159912|O3|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334729|NCT01159912|O2|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334730|NCT01159912|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334731|NCT01159912|O3|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334732|NCT01159912|O2|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334733|NCT01159912|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334734|NCT01159912|O3|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334735|NCT01159912|O2|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334736|NCT01159912|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334737|NCT01159912|O3|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334738|NCT01159912|O2|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334739|NCT01159912|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334740|NCT01159912|E3|Reported Event|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334741|NCT01159912|E2|Reported Event|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334742|NCT01159912|E1|Reported Event|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
334743|NCT01159769|B1|Baseline|Olopatadine 0.2%|1 drop self-administered in each eye once daily in the morning for 7 days
334744|NCT01159769|P1|Participant Flow|Olopatadine 0.2%|1 drop self-administered in each eye once daily in the morning for 7 days
334745|NCT01159769|O1|Outcome|Olopatadine 0.2%|1 drop self-administered in each eye once daily in the morning for 7 days
334746|NCT01159769|O1|Outcome|Olopatadine 0.2%|1 drop self-administered in each eye once daily in the morning for 7 days
334747|NCT01159769|E1|Reported Event|Olopatadine 0.2%|1 drop self-administered in each eye once daily in the morning for 7 days
334748|NCT01159743|B3|Baseline|Total|Total of all reporting groups
334749|NCT01159743|B2|Baseline|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
334785|NCT01159665|O4|Outcome|PPV 24 Hours (+2 Hours) After Injection|Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
334750|NCT01159743|B1|Baseline|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
334751|NCT01159743|P2|Participant Flow|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
334752|NCT01159743|P1|Participant Flow|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
334753|NCT01159743|O2|Outcome|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
334754|NCT01159743|O1|Outcome|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
334755|NCT01159743|O2|Outcome|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
334756|NCT01159743|O1|Outcome|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
334757|NCT01159743|O2|Outcome|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
334758|NCT01159743|O1|Outcome|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
334759|NCT01159743|O2|Outcome|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
334760|NCT01159743|O1|Outcome|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
334761|NCT01159743|E2|Reported Event|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
334762|NCT01159743|E1|Reported Event|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
334763|NCT01159691|B1|Baseline|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
334764|NCT01159691|P1|Participant Flow|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
334765|NCT01159691|O1|Outcome|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
334766|NCT01159691|O1|Outcome|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
334767|NCT01159691|O1|Outcome|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
334768|NCT01159691|O1|Outcome|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
334769|NCT01159691|E1|Reported Event|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
334770|NCT01159665|B7|Baseline|Total|Total of all reporting groups
334771|NCT01159665|B6|Baseline|PPV Without Injection|Control Arm, no ocriplasmin intravitreal injection
334772|NCT01159665|B5|Baseline|PPV 7 Days (+1 Day) After Injection|Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
334773|NCT01159665|B4|Baseline|PPV 24 Hours (+2 Hours) After Injection|Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
334774|NCT01159665|B3|Baseline|PPV 2-4 Hours After Injection|Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
334775|NCT01159665|B2|Baseline|PPV 31-60 Minutes After Injection|Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
334776|NCT01159665|B1|Baseline|PPV 5-30 Minutes After Injection|Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
334777|NCT01159665|P6|Participant Flow|PPV Without Injection|Control Arm, no ocriplasmin intravitreal injection
334778|NCT01159665|P5|Participant Flow|PPV 7 Days (+1 Day) After Injection|Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
334779|NCT01159665|P4|Participant Flow|PPV 24 Hours (+2 Hours) After Injection|Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
334780|NCT01159665|P3|Participant Flow|PPV 2-4 Hours After Injection|Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
334781|NCT01159665|P2|Participant Flow|PPV 31-60 Minutes After Injection|Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
334782|NCT01159665|P1|Participant Flow|PPV 5-30 Minutes After Injection|Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
334783|NCT01159665|O6|Outcome|PPV Without Injection|Control Arm, no ocriplasmin intravitreal injection
343106|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
334788|NCT01159665|O1|Outcome|PPV 5-30 Minutes After Injection|Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
334789|NCT01159665|O6|Outcome|PPV Without Injection|Control Arm, no ocriplasmin intravitreal injection
334790|NCT01159665|O5|Outcome|PPV 7 Days (+1 Day) After Injection|Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
334791|NCT01159665|O4|Outcome|PPV 24 Hours (+2 Hours) After Injection|Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
334792|NCT01159665|O3|Outcome|PPV 2-4 Hours After Injection|Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
334793|NCT01159665|O2|Outcome|PPV 31-60 Minutes After Injection|Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
334794|NCT01159665|O1|Outcome|PPV 5-30 Minutes After Injection|Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
334795|NCT01159665|E6|Reported Event|PPV Without Injection|Control Arm, no ocriplasmin intravitreal injection
334796|NCT01159665|E5|Reported Event|PPV 7 Days (+1 Day) After Injection|Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
334797|NCT01159665|E4|Reported Event|PPV 24 Hours (+2 Hours) After Injection|Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
334798|NCT01159665|E3|Reported Event|PPV 2-4 Hours After Injection|Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
334799|NCT01159665|E2|Reported Event|PPV 31-60 Minutes After Injection|Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
334800|NCT01159665|E1|Reported Event|PPV 5-30 Minutes After Injection|Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
334801|NCT01159600|B9|Baseline|Total|Total of all reporting groups
334802|NCT01159600|B8|Baseline|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334803|NCT01159600|B7|Baseline|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334804|NCT01159600|B6|Baseline|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334805|NCT01159600|B5|Baseline|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334806|NCT01159600|B4|Baseline|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
334807|NCT01159600|B3|Baseline|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
334808|NCT01159600|B2|Baseline|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
334809|NCT01159600|B1|Baseline|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
334810|NCT01159600|P8|Participant Flow|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334811|NCT01159600|P7|Participant Flow|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334812|NCT01159600|P6|Participant Flow|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334813|NCT01159600|P5|Participant Flow|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334814|NCT01159600|P4|Participant Flow|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
334815|NCT01159600|P3|Participant Flow|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
334816|NCT01159600|P2|Participant Flow|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
334817|NCT01159600|P1|Participant Flow|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
334818|NCT01159600|O8|Outcome|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334819|NCT01159600|O7|Outcome|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334820|NCT01159600|O6|Outcome|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334821|NCT01159600|O5|Outcome|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334822|NCT01159600|O4|Outcome|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
334823|NCT01159600|O3|Outcome|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
334824|NCT01159600|O2|Outcome|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
334825|NCT01159600|O1|Outcome|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
334826|NCT01159600|O8|Outcome|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334827|NCT01159600|O7|Outcome|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334828|NCT01159600|O6|Outcome|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334829|NCT01159600|O5|Outcome|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334830|NCT01159600|O4|Outcome|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
334831|NCT01159600|O3|Outcome|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
334832|NCT01159600|O2|Outcome|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
334833|NCT01159600|O1|Outcome|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks, in patients with background medication of metformin only.
334834|NCT01159600|O8|Outcome|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334835|NCT01159600|O7|Outcome|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334836|NCT01159600|O6|Outcome|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334837|NCT01159600|O5|Outcome|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334838|NCT01159600|O4|Outcome|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
334839|NCT01159600|O3|Outcome|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
334840|NCT01159600|O2|Outcome|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
334841|NCT01159600|O1|Outcome|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
334842|NCT01159600|O8|Outcome|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334843|NCT01159600|O7|Outcome|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334844|NCT01159600|O6|Outcome|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334845|NCT01159600|O5|Outcome|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334846|NCT01159600|O4|Outcome|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
334847|NCT01159600|O3|Outcome|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
334848|NCT01159600|O2|Outcome|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
334849|NCT01159600|O1|Outcome|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
334850|NCT01159600|E8|Reported Event|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334851|NCT01159600|E7|Reported Event|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334852|NCT01159600|E6|Reported Event|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334853|NCT01159600|E5|Reported Event|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
334854|NCT01159600|E4|Reported Event|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
334855|NCT01159600|E3|Reported Event|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
334856|NCT01159600|E2|Reported Event|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
334857|NCT01159600|E1|Reported Event|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
334858|NCT01159574|B1|Baseline|All Patients|"ClaPd therapy:~Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.~Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.~dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle~clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle~Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle"
334859|NCT01159574|P1|Participant Flow|All Patients|"ClaPd therapy:~Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.~Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.~dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle~clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle~Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle"
334860|NCT01159574|O1|Outcome|All Patients|"ClaPd therapy:~Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.~Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.~dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle~clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle~Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle"
334861|NCT01159574|O1|Outcome|All Patients|"ClaPd therapy:~Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.~Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.~dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle~clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle~Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle"
334862|NCT01159574|O1|Outcome|All Patients|"ClaPd therapy:~Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.~Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.~dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle~clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle~Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle"
334863|NCT01159574|E1|Reported Event|All Patients|"ClaPd therapy:~Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.~Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.~dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle~clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle~Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle"
334864|NCT01159535|B4|Baseline|Total|Total of all reporting groups
334865|NCT01159535|B3|Baseline|Treatment as Usual|"All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis.~Treatment as Usual: All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis."
334866|NCT01159535|B2|Baseline|Relapse Prevention (RP)|"The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions will be team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.~Relapse Prevention: intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)"
334867|NCT01159535|B1|Baseline|Mindfulness Based Relapse Prevention (MBRP)|Mindfulness Based Relapse Prevention: The MBRP intervention comprises 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments.
334868|NCT01159535|P3|Participant Flow|Treatment as Usual (TAU)|"All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis.~Treatment as Usual: All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis."
334869|NCT01159535|P2|Participant Flow|Relapse Prevention (RP)|"The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions will be team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.~Relapse Prevention: intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)"
334870|NCT01159535|P1|Participant Flow|Mindfulness Based Relapse Prevention (MBRP)|"Mindfulness Based Relapse Prevention~Mindfulness Based Relapse Prevention: The MBRP intervention comprises 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments."
334871|NCT01159535|O3|Outcome|Treatment as Usual (TAU)|Treatment as Usual included continuing care services (including attendance at Alcoholics Anonymous, Narcotics Anonymous, or other self-help groups) as recommended by their treatment providers.
334872|NCT01159535|O2|Outcome|Relapse Prevention (RP)|The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions will be team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.
334908|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334873|NCT01159535|O1|Outcome|Mindfulness Based Relapse Prevention (MBRP)|"Mindfulness Based Relapse Prevention~Mindfulness Based Relapse Prevention: The MBRP intervention consisted of 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments."
334874|NCT01159535|E3|Reported Event|Treatment as Usual (TAU)|Treatment as Usual participants were enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants received ongoing support and monitoring by their continuing care providers on a regular basis.
334875|NCT01159535|E2|Reported Event|Relapse Prevention (RP)|"The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions were team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.~Relapse Prevention: intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)"
334876|NCT01159535|E1|Reported Event|Mindfulness-Based Relapse Prevention (MBRP)|Mindfulness Based Relapse Prevention comprises 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments.
334877|NCT01159431|B3|Baseline|Total|Total of all reporting groups
334878|NCT01159431|B2|Baseline|Control|Trigeminal Nerve Stimulation-Low Settings
334879|NCT01159431|B1|Baseline|Active|Trigeminal Nerve Stimulation-High Settings
334880|NCT01159431|P2|Participant Flow|Control|Trigeminal Nerve Stimulation-Low Settings
334881|NCT01159431|P1|Participant Flow|Active|Trigeminal Nerve Stimulation-High Settings
334882|NCT01159431|O2|Outcome|Control|Trigeminal Nerve Stimulation-Low Settings
334883|NCT01159431|O1|Outcome|Active|Trigeminal Nerve Stimulation-High Settings
334884|NCT01159431|O2|Outcome|Control|Trigeminal Nerve Stimulation-Low Settings
334885|NCT01159431|O1|Outcome|Treatment|Trigeminal Nerve Stimulation-High Settings
334886|NCT01159431|O2|Outcome|Control|
334887|NCT01159431|O1|Outcome|Treatment|
334888|NCT01159431|O4|Outcome|Treatment Group-Double Blind Period|
334889|NCT01159431|O3|Outcome|Treatment Group-Baseline|
334890|NCT01159431|O2|Outcome|Control Group-Double Blind Period|Sham Treatment
334891|NCT01159431|O1|Outcome|Control Group-Baseline|Baseline
334892|NCT01159431|O2|Outcome|Control|Trigeminal Nerve Stimulation-Low Settings
334893|NCT01159431|O1|Outcome|Treatment|Trigeminal Nerve Stimulation-High Settings
334894|NCT01159431|E2|Reported Event|Control|Trigeminal Nerve Stimulation-Low Settings
334895|NCT01159431|E1|Reported Event|Active|Trigeminal Nerve Stimulation-High Settings
334896|NCT01159262|B4|Baseline|Total|Total of all reporting groups
334897|NCT01159262|B3|Baseline|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334898|NCT01159262|B2|Baseline|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334899|NCT01159262|B1|Baseline|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334900|NCT01159262|P3|Participant Flow|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334901|NCT01159262|P2|Participant Flow|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334902|NCT01159262|P1|Participant Flow|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334903|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334904|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334905|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334906|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334907|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334967|NCT01158976|O2|Outcome|Soybean Oil|Placebo: soybean oils with strawberry flavoring
343107|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
334909|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334910|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334911|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334912|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334913|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334914|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334915|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334916|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334917|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334918|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334919|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334920|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334921|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334922|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334923|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334924|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334925|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334926|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334927|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334928|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334929|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334930|NCT01159262|E3|Reported Event|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334931|NCT01159262|E2|Reported Event|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
334932|NCT01159262|E1|Reported Event|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
335088|NCT01158378|B2|Baseline|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
334933|NCT01159171|B1|Baseline|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
334934|NCT01159171|P1|Participant Flow|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1 and 15; oxaliplatin 40 mg per square meter (mg/m^2) IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 orally (PO) twice daily (BID) on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
334935|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
334936|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
334937|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
334938|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
334939|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
334940|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
334941|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
334942|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Cycle 1 (28-Day Cycle) Participants received 5 milligrams/kilograms (mg/kg) bevacizumab intravenously (IV) on Days 1 and 15; 40 mg/meter^2 (mg/m^2) oxaliplatin IV on Days 1, 8, 15, and 22; and 2000 mg/m^2 capecitabine orally (PO) in a divided dose every 12 hours within 30 minutes following a meal, on Days 1 through 14 followed by a rest period on Days 15 through 28. Cycle 1 was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
334943|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
334944|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
334945|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
334946|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
334947|NCT01159171|E1|Reported Event|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
334948|NCT01159054|B1|Baseline|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.~Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
334949|NCT01159054|P1|Participant Flow|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.~Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
334968|NCT01158976|O1|Outcome|DHA Supplementation|Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
334950|NCT01159054|O1|Outcome|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.~Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
334951|NCT01159054|O1|Outcome|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.~Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
334952|NCT01159054|O1|Outcome|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.~Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
334953|NCT01159054|O1|Outcome|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.~Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
334954|NCT01159054|O1|Outcome|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.~Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
334955|NCT01159054|O1|Outcome|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.~Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
334956|NCT01159054|O1|Outcome|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.~Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
334957|NCT01159054|O1|Outcome|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.~Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
334958|NCT01159054|O1|Outcome|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.~Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
334959|NCT01159054|E1|Reported Event|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.~Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
334960|NCT01158976|B3|Baseline|Total|Total of all reporting groups
334961|NCT01158976|B2|Baseline|Soybean Oil|Placebo: soybean oils with strawberry flavoring
334962|NCT01158976|B1|Baseline|DHA Supplementation|Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
334963|NCT01158976|P2|Participant Flow|Soybean Oil|Placebo: soybean oils with strawberry flavoring
334964|NCT01158976|P1|Participant Flow|DHA Supplementation|Docosahexanoic Acid (DHA): 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
334965|NCT01158976|O2|Outcome|Soybean Oil|Placebo: soybean oils with strawberry flavoring
334966|NCT01158976|O1|Outcome|DHA Supplementation|Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
334970|NCT01158976|O1|Outcome|DHA Supplementation|Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
334971|NCT01158976|O2|Outcome|Soybean Oil|Placebo: soybean oils with strawberry flavoring
334972|NCT01158976|O1|Outcome|DHA Supplementation|Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
334973|NCT01158976|O2|Outcome|Soybean Oil|Placebo: soybean oils with strawberry flavoring
334974|NCT01158976|O1|Outcome|DHA Supplementation|Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
334975|NCT01158976|O2|Outcome|Soybean Oil|Placebo: soybean oils with strawberry flavoring
334976|NCT01158976|O1|Outcome|DHA Supplementation|Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
334977|NCT01158976|O2|Outcome|Soybean Oil|Placebo: soybean oils with strawberry flavoring
334978|NCT01158976|O1|Outcome|DHA Supplementation|Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
334979|NCT01158976|O2|Outcome|Soybean Oil|Placebo: soybean oils with strawberry flavoring
334980|NCT01158976|O1|Outcome|DHA Supplementation|Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
334981|NCT01158976|O2|Outcome|Soybean Oil|Placebo: soybean oils with strawberry flavoring
334982|NCT01158976|O1|Outcome|DHA Supplementation|Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
334983|NCT01158976|O2|Outcome|Soybean Oil|Placebo: soybean oils with strawberry flavoring
334984|NCT01158976|O1|Outcome|DHA Supplementation|Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
334985|NCT01158976|O2|Outcome|Soybean Oil|Placebo: soybean oils with strawberry flavoring
334986|NCT01158976|O1|Outcome|DHA Supplementation|Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
334987|NCT01158976|O2|Outcome|Soybean Oil|Placebo: soybean oils with strawberry flavoring
334988|NCT01158976|O1|Outcome|DHA Supplementation|Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
334989|NCT01158976|O2|Outcome|Soybean Oil|Placebo: soybean oils with strawberry flavoring
334990|NCT01158976|O1|Outcome|DHA Supplementation|Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
334991|NCT01158976|O2|Outcome|Soybean Oil|Placebo: soybean oils with strawberry flavoring
334992|NCT01158976|O1|Outcome|DHA Supplementation|Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
334993|NCT01158976|O2|Outcome|Soybean Oil|Placebo: soybean oils with strawberry flavoring
334994|NCT01158976|O1|Outcome|DHA Supplementation|Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
334995|NCT01158976|O2|Outcome|Soybean Oil|Placebo: soybean oils with strawberry flavoring
334996|NCT01158976|O1|Outcome|DHA Supplementation|Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
334997|NCT01158976|O2|Outcome|Soybean Oil|Placebo: soybean oils with strawberry flavoring
334998|NCT01158976|O1|Outcome|DHA Supplementation|Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
334999|NCT01158976|O2|Outcome|Soybean Oil|Placebo: soybean oils with strawberry flavoring
335000|NCT01158976|O1|Outcome|DHA Supplementation|Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
335001|NCT01158976|O2|Outcome|Soybean Oil|Placebo: soybean oils with strawberry flavoring
335002|NCT01158976|O1|Outcome|DHA Supplementation|Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
335003|NCT01158976|E2|Reported Event|Soybean Oil|Placebo: soybean oils with strawberry flavoring
335004|NCT01158976|E1|Reported Event|DHA Supplementation|Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
335005|NCT01158924|B3|Baseline|Total|Total of all reporting groups
335006|NCT01158924|B2|Baseline|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
335007|NCT01158924|B1|Baseline|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
335008|NCT01158924|P2|Participant Flow|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
335009|NCT01158924|P1|Participant Flow|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
335010|NCT01158924|O2|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
335011|NCT01158924|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
335012|NCT01158924|O2|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
335013|NCT01158924|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
335014|NCT01158924|O2|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
335015|NCT01158924|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
335016|NCT01158924|O2|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
335017|NCT01158924|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
335018|NCT01158924|O2|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
335019|NCT01158924|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
335020|NCT01158924|E2|Reported Event|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
335021|NCT01158924|E1|Reported Event|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
335022|NCT01158716|B3|Baseline|Total|Total of all reporting groups
335023|NCT01158716|B2|Baseline|Control|
335024|NCT01158716|B1|Baseline|Remote Ischemic Preconditioning|Remote Ischemic Preconditioning: Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)
335025|NCT01158716|P2|Participant Flow|Control|
335026|NCT01158716|P1|Participant Flow|Remote Ischemic Preconditioning|Remote Ischemic Preconditioning: Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)
335027|NCT01158716|O2|Outcome|Control|
335028|NCT01158716|O1|Outcome|Remote Ischemic Preconditioning|Remote Ischemic Preconditioning: Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)
335029|NCT01158716|E2|Reported Event|Control|
335030|NCT01158716|E1|Reported Event|Remote Ischemic Preconditioning|Remote Ischemic Preconditioning: Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)
335031|NCT01158703|B3|Baseline|Total|Total of all reporting groups
335032|NCT01158703|B2|Baseline|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
335033|NCT01158703|B1|Baseline|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
335034|NCT01158703|P2|Participant Flow|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
335035|NCT01158703|P1|Participant Flow|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
335036|NCT01158703|O2|Outcome|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
335037|NCT01158703|O1|Outcome|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
335038|NCT01158703|O2|Outcome|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
335039|NCT01158703|O1|Outcome|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
335040|NCT01158703|O2|Outcome|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
335041|NCT01158703|O1|Outcome|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
335042|NCT01158703|O2|Outcome|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
335043|NCT01158703|O1|Outcome|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
335089|NCT01158378|B1|Baseline|Adherus Dural Sealant|Adherus Dural Sealant: In situ polymerizing sealant
335045|NCT01158703|O1|Outcome|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
335046|NCT01158703|O2|Outcome|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
335047|NCT01158703|O1|Outcome|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
335048|NCT01158703|E2|Reported Event|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
335049|NCT01158703|E1|Reported Event|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
335050|NCT01158573|B5|Baseline|Total|Total of all reporting groups
335051|NCT01158573|B4|Baseline|Non Asthma Obese (NAO)|BMI > 30 Obese
335052|NCT01158573|B3|Baseline|Asthma Non Obese (ANO)|"BMI 20-25 Non obese~Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use."
335053|NCT01158573|B2|Baseline|Non Asthma Non-obese (NANO)|BMI 20-25 Non obese
335054|NCT01158573|B1|Baseline|Obese Asthma (OA)|"BMI > 30 Obese~Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use."
335055|NCT01158573|P4|Participant Flow|Non Asthma, Obese|BMI .30
335056|NCT01158573|P3|Participant Flow|Asthma, Non-obese|BMI 20-25 Non obese
335057|NCT01158573|P2|Participant Flow|Non Asthma, Non-obese|BMI 20-25 Non obese
335058|NCT01158573|P1|Participant Flow|Obese Asthma|"Obese Asthma (OA)~BMI > 30 Obese~Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use."
335059|NCT01158573|O4|Outcome|Non Asthma Obese (NAO)|BMI > 30 Obese
335060|NCT01158573|O3|Outcome|Asthma Non Obese (ANO)|"BMI 20-25 Non obese~Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use."
335061|NCT01158573|O2|Outcome|Non Asthma Non-obese (NANO)|BMI 20-25 Non obese
335062|NCT01158573|O1|Outcome|Obese Asthma (OA)|"BMI > 30 Obese~Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use."
335063|NCT01158573|O4|Outcome|Non Asthma Obese (NAO)|BMI > 30 Obese
335064|NCT01158573|O3|Outcome|Asthma Non Obese (ANO)|"BMI 20-25 Non obese~Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use."
335065|NCT01158573|O2|Outcome|Non Asthma Non-obese (NANO)|BMI 20-25 Non obese
335066|NCT01158573|O1|Outcome|Obese Asthma (OA)|"BMI > 30 Obese~Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use."
335067|NCT01158573|O4|Outcome|Non Asthma Obese (NAO)|BMI > 30 Obese
335068|NCT01158573|O3|Outcome|Asthma Non Obese (ANO)|"BMI 20-25 Non obese~Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use."
335069|NCT01158573|O2|Outcome|Non Asthma Non-obese (NANO)|BMI 20-25 Non obese
335070|NCT01158573|O1|Outcome|Obese Asthma (OA)|"BMI > 30 Obese~Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use."
335071|NCT01158573|O4|Outcome|Non Asthma Obese (NAO)|BMI > 30 Obese
335072|NCT01158573|O3|Outcome|Asthma Non Obese (ANO)|"BMI 20-25 Non obese~Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use."
335073|NCT01158573|O2|Outcome|Non Asthma Non-obese (NANO)|BMI 20-25 Non obese
335074|NCT01158573|O1|Outcome|Obese Asthma (OA)|"BMI > 30 Obese~Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use."
335075|NCT01158573|E4|Reported Event|Non Asthma Obese (NAO)|BMI > 30 Obese
335076|NCT01158573|E3|Reported Event|Asthma Non Obese (ANO)|"BMI 20-25 Non obese~Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use."
335077|NCT01158573|E2|Reported Event|Non Asthma Non-obese (NANO)|BMI 20-25 Non obese
335078|NCT01158573|E1|Reported Event|Obese Asthma (OA)|"BMI > 30 Obese~Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use."
335079|NCT01158534|B1|Baseline|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
335080|NCT01158534|P1|Participant Flow|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
335081|NCT01158534|O1|Outcome|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
335082|NCT01158534|O1|Outcome|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
335083|NCT01158534|O1|Outcome|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
335084|NCT01158534|O1|Outcome|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
335085|NCT01158534|O1|Outcome|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
335086|NCT01158534|E1|Reported Event|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
335087|NCT01158378|B3|Baseline|Total|Total of all reporting groups
343108|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
335090|NCT01158378|P2|Participant Flow|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
335091|NCT01158378|P1|Participant Flow|Adherus Dural Sealant|Adherus Dural Sealant: In situ polymerizing sealant
335092|NCT01158378|O2|Outcome|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
335093|NCT01158378|O1|Outcome|Adherus Dural Sealant|Adherus Dural Sealant: In situ polymerizing sealant
335094|NCT01158378|O2|Outcome|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
335095|NCT01158378|O1|Outcome|Adherus Dural Sealant System|Adherus Dural Sealant: In situ polymerizing sealant
335096|NCT01158378|O2|Outcome|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
335097|NCT01158378|O1|Outcome|Adherus Dural Sealant System|Adherus Dural Sealant: In situ polymerizing sealant
335098|NCT01158378|O2|Outcome|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
335099|NCT01158378|O1|Outcome|Adherus Dural Sealant System|Adherus Dural Sealant: In situ polymerizing sealant
335100|NCT01158378|E2|Reported Event|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
335101|NCT01158378|E1|Reported Event|Adherus Dural Sealant System|Adherus Dural Sealant: In situ polymerizing sealant
335102|NCT01158261|B1|Baseline|EVICEL® Fibrin Sealant (Human)|All procedures were performed according to the surgeon’s standard of care. EVICEL® Fibrin Sealant was prepared and used according to the current approved instructions for use and product indication. The anastomoses were constructed and checked for bleeding. Anastomotic repair sutures were placed and then, if bleeding requiring adjunctive treatment persisted, arterial clamps were re-applied. The surgeon then applied EVICEL® by dripping onto the anastomotic site/s according to his/her standard practice. Arterial clamps were removed approximately 1-minute following the end of product application to allow for curing. All subjects were followed for approximately 4 weeks following surgery.
335103|NCT01158261|P1|Participant Flow|EVICEL® Fibrin Sealant (Human)|All procedures were performed according to the surgeon’s standard of care. EVICEL® Fibrin Sealant was prepared and used according to the current approved instructions for use and product indication. The anastomoses were constructed and checked for bleeding. Anastomotic repair sutures were placed and then, if bleeding requiring adjunctive treatment persisted, arterial clamps were re-applied. The surgeon then applied EVICEL® by dripping onto the anastomotic site/s according to his/her standard practice. Arterial clamps were removed approximately 1-minute following the end of product application to allow for curing. All subjects were followed for approximately 4 weeks following surgery.
335104|NCT01158261|O1|Outcome|EVICEL® Fibrin Sealant (Human)|
335105|NCT01158261|E1|Reported Event|EVICEL® Fibrin Sealant (Human)|"An adverse event (AE) was defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of the EVICEL® product. For the purpose of this protocol, an AE was any untoward medical occurrence in a study subject that may be related or possibly related to the EVICEL® product. The relatedness to EVICEL® was based on the investigator’s assessment.~In the original version of the protocol, the SAE definition did not require that the AE be related or possibly related to the treatment. This discrepancy with the AE definition resulted in the sites reporting non-EVICEL® related AEs and SAEs prior to the amended protocol implementation."
335106|NCT01158118|B3|Baseline|Total|Total of all reporting groups
335107|NCT01158118|B2|Baseline|Arm 2 - Recipient|"Conditioning Regimens~fludarabine and busulfan +/- thymoglobulin~fractionated total body irradiation and cyclophosphamide~busulfan and cyclophosphamide~single dose total body irradiation and cyclophosphamide~Day -2 = GvHD prophylaxis~Day 0 or +1 = PBSC transplant~Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
335108|NCT01158118|B1|Baseline|Arm 1 - Donor|"Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)~Day 5: Mobilization with 320 mcg/kg plerixafor IV~Day 5: Leukopheresis~If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6."
335109|NCT01158118|P2|Participant Flow|Arm 2 - Recipient|"Conditioning Regimens~fludarabine and busulfan +/- thymoglobulin~fractionated total body irradiation and cyclophosphamide~busulfan and cyclophosphamide~single dose total body irradiation and cyclophosphamide~Day -2 = GvHD prophylaxis~Day 0 or +1 = PBSC transplant~Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
335110|NCT01158118|P1|Participant Flow|Arm 1 - Donor|"Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)~Day 5: Mobilization with 320 mcg/kg plerixafor IV~Day 5: Leukopheresis~If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6."
335111|NCT01158118|O1|Outcome|Arm 2 - Recipient|"Conditioning Regimens~fludarabine and busulfan +/- thymoglobulin~fractionated total body irradiation and cyclophosphamide~busulfan and cyclophosphamide~single dose total body irradiation and cyclophosphamide~Day -2 = GvHD prophylaxis~Day 0 or +1 = PBSC transplant~Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
335112|NCT01158118|O1|Outcome|Arm 2 - Recipient|"Conditioning Regimens~fludarabine and busulfan +/- thymoglobulin~fractionated total body irradiation and cyclophosphamide~busulfan and cyclophosphamide~single dose total body irradiation and cyclophosphamide~Day -2 = GvHD prophylaxis~Day 0 or +1 = PBSC transplant~Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
335113|NCT01158118|O1|Outcome|Arm 2 - Recipient|"Conditioning Regimens~fludarabine and busulfan +/- thymoglobulin~fractionated total body irradiation and cyclophosphamide~busulfan and cyclophosphamide~single dose total body irradiation and cyclophosphamide~Day -2 = GvHD prophylaxis~Day 0 or +1 = PBSC transplant~Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
335114|NCT01158118|O1|Outcome|Arm 2 - Recipient|"Conditioning Regimens~fludarabine and busulfan +/- thymoglobulin~fractionated total body irradiation and cyclophosphamide~busulfan and cyclophosphamide~single dose total body irradiation and cyclophosphamide~Day -2 = GvHD prophylaxis~Day 0 or +1 = PBSC transplant~Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
335115|NCT01158118|O1|Outcome|Arm 2 - Recipient|"Conditioning Regimens~fludarabine and busulfan +/- thymoglobulin~fractionated total body irradiation and cyclophosphamide~busulfan and cyclophosphamide~single dose total body irradiation and cyclophosphamide~Day -2 = GvHD prophylaxis~Day 0 or +1 = PBSC transplant~Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
337412|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
335116|NCT01158118|O1|Outcome|Arm 2 - Recipient|"Conditioning Regimens~fludarabine and busulfan +/- thymoglobulin~fractionated total body irradiation and cyclophosphamide~busulfan and cyclophosphamide~single dose total body irradiation and cyclophosphamide~Day -2 = GvHD prophylaxis~Day 0 or +1 = PBSC transplant~Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
335117|NCT01158118|O1|Outcome|Arm 2 - Recipient|"Conditioning Regimens~fludarabine and busulfan +/- thymoglobulin~fractionated total body irradiation and cyclophosphamide~busulfan and cyclophosphamide~single dose total body irradiation and cyclophosphamide~Day -2 = GvHD prophylaxis~Day 0 or +1 = PBSC transplant~Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
335118|NCT01158118|O1|Outcome|Arm 2 - Recipient|"Conditioning Regimens~fludarabine and busulfan +/- thymoglobulin~fractionated total body irradiation and cyclophosphamide~busulfan and cyclophosphamide~single dose total body irradiation and cyclophosphamide~Day -2 = GvHD prophylaxis~Day 0 or +1 = PBSC transplant~Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
335119|NCT01158118|O1|Outcome|Arm 1 - Donor|"Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)~Day 5: Mobilization with 320 mcg/kg plerixafor IV~Day 5: Leukopheresis~If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6."
335120|NCT01158118|O1|Outcome|Arm 1 - Donor|"Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)~Day 5: Mobilization with 320 mcg/kg plerixafor IV~Day 5: Leukopheresis~If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6."
335121|NCT01158118|O1|Outcome|Arm 1 - Donor|"Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)~Day 5: Mobilization with 320 mcg/kg plerixafor IV~Day 5: Leukopheresis~If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6."
335122|NCT01158118|O1|Outcome|Arm 1 - Donor|"Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)~Day 5: Mobilization with 320 mcg/kg plerixafor IV~Day 5: Leukopheresis~If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6."
335123|NCT01158118|E2|Reported Event|Arm 2 - Recipient|"Conditioning Regimens~fludarabine and busulfan +/- thymoglobulin~fractionated total body irradiation and cyclophosphamide~busulfan and cyclophosphamide~single dose total body irradiation and cyclophosphamide~Day -2 = GvHD prophylaxis~Day 0 or +1 = PBSC transplant~Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
335124|NCT01158118|E1|Reported Event|Arm 1 - Donor|"Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)~Day 5: Mobilization with 320 mcg/kg plerixafor IV~Day 5: Leukopheresis~If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6."
335125|NCT01157845|B1|Baseline|Laboratory Assay|BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
335126|NCT01157845|P1|Participant Flow|Laboratory Assay|BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
335127|NCT01157845|O1|Outcome|Laboratory Assay|BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
335128|NCT01157845|O1|Outcome|Laboratory Assay|BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
335129|NCT01157845|E1|Reported Event|Laboratory Assay|BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
335130|NCT01157533|B1|Baseline|Vancomycin Loading|Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
335131|NCT01157533|P1|Participant Flow|Vancomycin Loading|Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
335132|NCT01157533|O1|Outcome|Vancomycin Loading|Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
335133|NCT01157533|E1|Reported Event|Vancomycin Loading|Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
335134|NCT01157429|B3|Baseline|Total|Total of all reporting groups
335135|NCT01157429|B2|Baseline|Placebo Pill|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.~Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol."
335136|NCT01157429|B1|Baseline|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.~D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
335137|NCT01157429|P2|Participant Flow|Placebo Pill|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.~Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol."
335138|NCT01157429|P1|Participant Flow|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.~D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
335139|NCT01157429|O2|Outcome|Placebo Pill|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.~Placebo pill: Placebo pill by mouth prior to sessions 5-12 of teh 12-session CBT protocol."
335140|NCT01157429|O1|Outcome|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.~D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
343109|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
335141|NCT01157429|E2|Reported Event|Placebo Pill|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.~Placebo pill: Placebo pill by mouth prior to sessions 5-12 of teh 12-session CBT protocol."
335142|NCT01157429|E1|Reported Event|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.~D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
335143|NCT01157416|B3|Baseline|Total|Total of all reporting groups
335144|NCT01157416|B2|Baseline|Placebo Plus CBT|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.~Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol."
335145|NCT01157416|B1|Baseline|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.~D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
335146|NCT01157416|P2|Participant Flow|Placebo Plus CBT|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.~Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol."
335147|NCT01157416|P1|Participant Flow|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.~D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
335148|NCT01157416|O2|Outcome|Placebo Plus CBT|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.~Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol."
335149|NCT01157416|O1|Outcome|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.~D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
335150|NCT01157416|E2|Reported Event|Placebo Plus CBT|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.~Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol."
335151|NCT01157416|E1|Reported Event|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.~D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
335152|NCT01157377|B8|Baseline|Total|Total of all reporting groups
335153|NCT01157377|B7|Baseline|Placebo to AGN-214868|Placebo to AGN-214868 injected into the bladder on Day 1.
335154|NCT01157377|B6|Baseline|AGN-214868 Total Dose 60000 ng|AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
335155|NCT01157377|B5|Baseline|AGN-214868 Total Dose 18000 ng|AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
335156|NCT01157377|B4|Baseline|AGN-214868 Total Dose 6000 ng|AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
335157|NCT01157377|B3|Baseline|AGN-214868 Total Dose 2000 ng|AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
335158|NCT01157377|B2|Baseline|AGN-214868 Total Dose 1000 ng|AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
335159|NCT01157377|B1|Baseline|AGN-214868 Total Dose 500 ng|AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
335160|NCT01157377|P7|Participant Flow|Placebo to AGN-214868|Placebo to AGN-214868 injected into the bladder on Day 1.
335161|NCT01157377|P6|Participant Flow|AGN-214868 Total Dose 60000 ng|AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
335162|NCT01157377|P5|Participant Flow|AGN-214868 Total Dose 18000 ng|AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
335163|NCT01157377|P4|Participant Flow|AGN-214868 Total Dose 6000 ng|AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
335164|NCT01157377|P3|Participant Flow|AGN-214868 Total Dose 2000 ng|AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
335165|NCT01157377|P2|Participant Flow|AGN-214868 Total Dose 1000 ng|AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
335166|NCT01157377|P1|Participant Flow|AGN-214868 Total Dose 500 ng|AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
335167|NCT01157377|O7|Outcome|Placebo to AGN-214868|Placebo to AGN-214868 injected into the bladder on Day 1.
335168|NCT01157377|O6|Outcome|AGN-214868 Total Dose 60000 ng|AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
335169|NCT01157377|O5|Outcome|AGN-214868 Total Dose 18000 ng|AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
335170|NCT01157377|O4|Outcome|AGN-214868 Total Dose 6000 ng|AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
335171|NCT01157377|O3|Outcome|AGN-214868 Total Dose 2000 ng|AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
335172|NCT01157377|O2|Outcome|AGN-214868 Total Dose 1000 ng|AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
335173|NCT01157377|O1|Outcome|AGN-214868 Total Dose 500 ng|AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
335174|NCT01157377|E7|Reported Event|Placebo to AGN-214868|Placebo to AGN-214868 injected into the bladder on Day 1.
335175|NCT01157377|E6|Reported Event|AGN-214868 Total Dose 60000 ng|AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
335176|NCT01157377|E5|Reported Event|AGN-214868 Total Dose 18000 ng|AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
335177|NCT01157377|E4|Reported Event|AGN-214868 Total Dose 6000 ng|AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
335178|NCT01157377|E3|Reported Event|AGN-214868 Total Dose 2000 ng|AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
335179|NCT01157377|E2|Reported Event|AGN-214868 Total Dose 1000 ng|AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
335180|NCT01157377|E1|Reported Event|AGN-214868 Total Dose 500 ng|AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
335181|NCT01157351|B3|Baseline|Total|Total of all reporting groups
335236|NCT01157182|P2|Participant Flow|Activella® (Reference) First|1/0.5 mg Activella® Tablets reference product dosed in first period followed by 1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in the second period.
335182|NCT01157351|B2|Baseline|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
335183|NCT01157351|B1|Baseline|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
335184|NCT01157351|P2|Participant Flow|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
335185|NCT01157351|P1|Participant Flow|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
335186|NCT01157351|O2|Outcome|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
335187|NCT01157351|O1|Outcome|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
335188|NCT01157351|O2|Outcome|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
335189|NCT01157351|O1|Outcome|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
335190|NCT01157351|O2|Outcome|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
335191|NCT01157351|O1|Outcome|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
335192|NCT01157351|O2|Outcome|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
335193|NCT01157351|O1|Outcome|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
335194|NCT01157351|O2|Outcome|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
335195|NCT01157351|O1|Outcome|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
335196|NCT01157351|O2|Outcome|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
335197|NCT01157351|O1|Outcome|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
335198|NCT01157351|E2|Reported Event|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
335199|NCT01157351|E1|Reported Event|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
335200|NCT01157234|B3|Baseline|Total|Total of all reporting groups
335201|NCT01157234|B2|Baseline|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335202|NCT01157234|B1|Baseline|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335203|NCT01157234|P2|Participant Flow|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335204|NCT01157234|P1|Participant Flow|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335205|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335206|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335207|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335208|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335237|NCT01157182|P1|Participant Flow|Estradiol/Norethindrone Acetate (Test) First|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in first period followed by 1/0.5 mg Activella® Tablets reference product dosed in the second period.
335209|NCT01157234|O2|Outcome|Metoprolol >/=50 Years Old|Hypertensive kidney transplant recipients age 50 years or higher treated with Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335210|NCT01157234|O1|Outcome|Nebivolol >/=50 Years Old|Hypertensive kidney transplant recipients age 50 years or higher treated with Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335211|NCT01157234|O2|Outcome|Metoprolol <50 Years Old|Hypertensive kidney transplant recipients age less than 50 years treated with Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335212|NCT01157234|O1|Outcome|Nebivolol >/=50 Years Old|Hypertensive kidney transplant recipients age 50 years or higher treated with Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335213|NCT01157234|O2|Outcome|Metoprolol <50 Years Old|Hypertensive kidney transplant recipients less than 50 years of age treated with Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335214|NCT01157234|O1|Outcome|Nebivolol < 50 Years Old|Hypertensive kidney transplant recipients less than 50 years of age treated with Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335215|NCT01157234|O2|Outcome|Metoprolol >/= 50 Year Old|Hypertensive kidney transplant recipients age 50 years or higher treated with Metoprolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study
335216|NCT01157234|O1|Outcome|Nebivolol <50 Year Old|Hypertensive kidney transplant recipients less than 50 years of age treated with Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study
335217|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335218|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335219|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335220|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335221|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335222|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335223|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335224|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335225|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335226|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335227|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335228|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335229|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335230|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
335231|NCT01157234|E2|Reported Event|Metoprolol|"Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.~Metoprolol: Metoprolol 25 mg twice daily, titrated to a maximum total daily dose of 400 mg to achieve a blood pressure < 140/90."
335232|NCT01157234|E1|Reported Event|Nebivolol|"Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.~Nebivolol: Nebivolol 5 mg once daily, titrated to a maximum total daily dose of 40 mg to achieve a blood pressure of < 140/ 90."
335233|NCT01157182|B3|Baseline|Total|Total of all reporting groups
335234|NCT01157182|B2|Baseline|Activella® (Reference) First|1/0.5 mg Activella® Tablets reference product dosed in first period followed by 1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in the second period.
335235|NCT01157182|B1|Baseline|Estradiol/Norethindrone Acetate (Test) First|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in first period followed by 1/0.5 mg Activella® Tablets reference product dosed in the second period.
335238|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
335239|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
335240|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
335241|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
335242|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
335243|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
335244|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
335245|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
335246|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
335247|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
335248|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
335249|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
335250|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
335251|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
335252|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
335253|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
335254|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
335255|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
335256|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
335257|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
335258|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
335259|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
335260|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
335261|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
335262|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
335263|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
335264|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
335265|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
335266|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
335267|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
335268|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
335269|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
335270|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
335271|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
335272|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
335273|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
335274|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
335275|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
335276|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
335277|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
335278|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
335279|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
335280|NCT01157182|E2|Reported Event|Activella® (Reference) First|1/0.5 mg Activella® Tablets reference product dosed in first period followed by 1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in the second period.
335281|NCT01157182|E1|Reported Event|Estradiol/Norethindrone Acetate (Test) First|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in first period followed by 1/0.5 mg Activella® Tablets reference product dosed in the second period.
335282|NCT01157169|B3|Baseline|Total|Total of all reporting groups
335283|NCT01157169|B2|Baseline|Subutex® (Reference) First|8 mg Subutex® Sublingual Tablets reference product dosed in first period followed by 8 mg Buprenorphine Sublingual Tablets test product dosed in the second period.
335385|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
335284|NCT01157169|B1|Baseline|Buprenorphine (Test) First|8 mg Buprenorphine Sublingual Tablets test product dosed in first period followed by 8 mg Subutex® Sublingual Tablets reference product dosed in the second period.
335285|NCT01157169|P2|Participant Flow|Subutex® (Reference) First|8 mg Subutex® Sublingual Tablets reference product dosed in first period followed by 8 mg Buprenorphine Sublingual Tablets test product dosed in the second period.
335286|NCT01157169|P1|Participant Flow|Buprenorphine (Test) First|8 mg Buprenorphine Sublingual Tablets test product dosed in first period followed by 8 mg Subutex® Sublingual Tablets reference product dosed in the second period.
335287|NCT01157169|O2|Outcome|Subutex® (Reference)|8 mg Subutex® Sublingual Tablets reference product dosed in either period.
335288|NCT01157169|O1|Outcome|Buprenorphine (Test)|8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
335289|NCT01157169|O2|Outcome|Subutex® (Reference)|8 mg Subutex® Sublingual Tablets reference product dosed in either period.
335290|NCT01157169|O1|Outcome|Buprenorphine (Test)|8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
335291|NCT01157169|O2|Outcome|Subutex® (Reference)|8 mg Subutex® Sublingual Tablets reference product dosed in either period.
335292|NCT01157169|O1|Outcome|Buprenorphine (Test)|8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
335293|NCT01157169|O2|Outcome|Subutex® (Reference)|8 mg Subutex® Sublingual Tablets reference product dosed in either period.
335294|NCT01157169|O1|Outcome|Buprenorphine (Test)|8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
335295|NCT01157169|O2|Outcome|Subutex® (Reference)|8 mg Subutex® Sublingual Tablets reference product dosed in either period.
335296|NCT01157169|O1|Outcome|Buprenorphine (Test)|8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
335297|NCT01157169|O2|Outcome|Subutex® (Reference)|8 mg Subutex® Sublingual Tablets reference product dosed in either period.
335298|NCT01157169|O1|Outcome|Buprenorphine (Test)|8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
335299|NCT01157169|E2|Reported Event|Subutex® (Reference) First|8 mg Subutex® Sublingual Tablets reference product dosed in first period followed by 8 mg Buprenorphine Sublingual Tablets test product dosed in the second period.
335300|NCT01157169|E1|Reported Event|Buprenorphine (Test) First|8 mg Buprenorphine Sublingual Tablets test product dosed in first period followed by 8 mg Subutex® Sublingual Tablets reference product dosed in the second period.
335301|NCT01157117|B4|Baseline|Total|Total of all reporting groups
335302|NCT01157117|B3|Baseline|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
335303|NCT01157117|B2|Baseline|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335304|NCT01157117|B1|Baseline|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335305|NCT01157117|P3|Participant Flow|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
335306|NCT01157117|P2|Participant Flow|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335307|NCT01157117|P1|Participant Flow|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335308|NCT01157117|O3|Outcome|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
335309|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
343110|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
335310|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335311|NCT01157117|O3|Outcome|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
335312|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335313|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335314|NCT01157117|O3|Outcome|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
335315|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335316|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335317|NCT01157117|O3|Outcome|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
335318|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335319|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335320|NCT01157117|O3|Outcome|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
335321|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335386|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
335387|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
335388|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
335661|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335322|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335323|NCT01157117|O3|Outcome|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
335324|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335325|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335326|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335327|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335328|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335329|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335330|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335331|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335332|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335662|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335333|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335334|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335335|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335336|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335337|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335338|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335339|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335340|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335341|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335342|NCT01157117|E3|Reported Event|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
335343|NCT01157117|E2|Reported Event|Placebo for Omalizumab/Milk OIT|Placebo for omalizumab: Placebo for omalizumab is injected subcutaneously every 2-4 weeks for 16 months at a volume designed to match that of the omalizumab treatment group (determined by the participant's IgE level and weight).
335389|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
335390|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
335663|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335344|NCT01157117|E1|Reported Event|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
335345|NCT01157078|B3|Baseline|Total|Total of all reporting groups
335346|NCT01157078|B2|Baseline|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
335347|NCT01157078|B1|Baseline|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
335348|NCT01157078|P2|Participant Flow|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
335349|NCT01157078|P1|Participant Flow|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
335350|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
335351|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
335352|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
335353|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
335354|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
335355|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
335356|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
335357|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
335358|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
335359|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
335360|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
335361|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
335362|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
335363|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
335364|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
335365|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
335366|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
335367|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
335368|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
335369|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
335370|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
335371|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
335372|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
335373|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
335374|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
335375|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
335376|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
335377|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
335378|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
335379|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
335380|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
335381|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
335382|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
335383|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
335384|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
335391|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
335392|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
335393|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
335394|NCT01157078|E2|Reported Event|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
335395|NCT01157078|E1|Reported Event|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
335396|NCT01157065|B3|Baseline|Total|Total of all reporting groups
335397|NCT01157065|B2|Baseline|Lucentis|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
335398|NCT01157065|B1|Baseline|AL-78898A|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
335399|NCT01157065|P2|Participant Flow|Lucentis|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
335400|NCT01157065|P1|Participant Flow|AL-78898A|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
335401|NCT01157065|O2|Outcome|Lucentis|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
335402|NCT01157065|O1|Outcome|AL-78898A|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
335403|NCT01157065|O2|Outcome|Lucentis|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
335404|NCT01157065|O1|Outcome|AL-78898A|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
335405|NCT01157065|E2|Reported Event|Lucentis|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
335406|NCT01157065|E1|Reported Event|AL-78898A|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
335407|NCT01156987|B3|Baseline|Total|Total of all reporting groups
335408|NCT01156987|B2|Baseline|Breast Cancer Patients|"Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar"
335409|NCT01156987|B1|Baseline|Healthy Volunteers|"Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods."
335410|NCT01156987|P2|Participant Flow|Breast Cancer Patients|"Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained. 10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar"
335411|NCT01156987|P1|Participant Flow|Healthy Volunteers|"Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods."
335412|NCT01156987|O2|Outcome|Breast Cancer Patients|"Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar"
335529|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
343111|NCT01136382|E2|Reported Event|Placebo pMDI b.i.d.|
335413|NCT01156987|O1|Outcome|Healthy Volunteers|"Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods."
335414|NCT01156987|E2|Reported Event|Breast Cancer Patients|"Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar"
335415|NCT01156987|E1|Reported Event|Healthy Volunteers|"Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods."
335416|NCT01156844|B5|Baseline|Total|Total of all reporting groups
335417|NCT01156844|B4|Baseline|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
335418|NCT01156844|B3|Baseline|Indacaterol 150 µg (Every Other Day)|Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
335419|NCT01156844|B2|Baseline|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
335420|NCT01156844|B1|Baseline|Indacaterol 37.5 µg (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
335421|NCT01156844|P4|Participant Flow|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
335422|NCT01156844|P3|Participant Flow|Indacaterol 150 µg (Every Other Day)|Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
335423|NCT01156844|P2|Participant Flow|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
335452|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335424|NCT01156844|P1|Participant Flow|Indacaterol 37.5 µg (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
335425|NCT01156844|O3|Outcome|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) such as salbutamol/albuterol was available for rescue use throughout the study.
335426|NCT01156844|O2|Outcome|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
335427|NCT01156844|O1|Outcome|Indacaterol 37.5 µg (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
335428|NCT01156844|O3|Outcome|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) such as salbutamol/albuterol was available for rescue use throughout the study.
335429|NCT01156844|O2|Outcome|Indacaterol 150 µg (Every Other Day)|Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
335430|NCT01156844|O1|Outcome|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
335431|NCT01156844|O3|Outcome|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) such as salbutamol/albuterol was available for rescue use throughout the study.
335432|NCT01156844|O2|Outcome|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
335433|NCT01156844|O1|Outcome|Indacaterol 37.5 µg (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
335434|NCT01156844|O4|Outcome|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
335435|NCT01156844|O3|Outcome|Indacaterol 150 µg (Every Other Day)|Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
335436|NCT01156844|O2|Outcome|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
335566|NCT01156675|O3|Outcome|No Treatment|Not treated with FLEXUS or X-STOP
337413|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
335437|NCT01156844|O1|Outcome|Indacaterol 37.5 µg (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
335438|NCT01156844|E4|Reported Event|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
335439|NCT01156844|E3|Reported Event|Indacaterol 150 ug (Every Other Day)|Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
335440|NCT01156844|E2|Reported Event|Indacaterol 75 ug (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
335441|NCT01156844|E1|Reported Event|Indacaterol 37.5 ug (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
335442|NCT01156792|B1|Baseline|All Treatments Combined|In a total of 4 treatment periods (each of 6 weeks - the first 3 weeks considered as active washout), participants received 4 of the 5 possible treatments (A/B/C/D/E) in a double-blind double-dummy, cross-over manner. Fluticasone propionate (FP) 100 µg oral inhalation was a part of each treatment. Added regimen were, A: GSK2190915 100 milligrams (mg) once daily (OD), B: GSK2190915 300 mg OD, C: montelukast 10 mg OD, D: placebo twice daily (BID), E: salmeterol 50 µg and placebo BID. Albuterol aerosol was provided as a rescue inhalation.
335443|NCT01156792|P1|Participant Flow|All Treatments Combined|In a total of 4 treatment periods (each of 6 weeks - the first 3 weeks considered as active washout), participants received 4 of the 5 possible treatments (A/B/C/D/E) in a double-blind double-dummy, cross-over manner. Fluticasone propionate (FP) 100 µg oral inhalation was a part of each treatment. Added regimen were, A: GSK2190915 100 milligrams (mg) once daily (OD), B: GSK2190915 300 mg OD, C: montelukast 10 mg OD, D: placebo twice daily (BID), E: salmeterol 50 µg and placebo BID. Albuterol aerosol was provided as a rescue inhalation.
335444|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335445|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
335446|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335447|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335448|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
335449|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335450|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
335451|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
343112|NCT01136382|E1|Reported Event|Budesonide pMDI 160mcg b.i.d.|
335453|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
335454|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335455|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
335456|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335457|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335458|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
335459|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335460|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
335461|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335462|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335463|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
335464|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335465|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
335466|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335467|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335468|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
335469|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335567|NCT01156675|O2|Outcome|X-STOP® Interspinous Spacer|X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the XSTOP® Spacer
335470|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
335471|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335472|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335473|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
335474|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335475|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
335476|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335477|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335478|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
335479|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335480|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
335481|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335482|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335483|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
335484|NCT01156792|O3|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
335485|NCT01156792|O2|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335486|NCT01156792|O1|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335504|NCT01156792|E3|Reported Event|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335487|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335488|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
335489|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335490|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335491|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
335492|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335493|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
335494|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335495|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335496|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
335497|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335498|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
335499|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335500|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335501|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
335502|NCT01156792|E5|Reported Event|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335503|NCT01156792|E4|Reported Event|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
335568|NCT01156675|O1|Outcome|FLEXUS™ Interspinous Spacer|FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
335505|NCT01156792|E2|Reported Event|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
335506|NCT01156792|E1|Reported Event|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
335507|NCT01156701|B1|Baseline|All Patients Included in the Analysis|All patients at least 5 years old enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009
335508|NCT01156701|P4|Participant Flow|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
335509|NCT01156701|P3|Participant Flow|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
335510|NCT01156701|P2|Participant Flow|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
335511|NCT01156701|P1|Participant Flow|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
335512|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
335513|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
335514|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
335515|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
335516|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
335517|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
335518|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
335519|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
335520|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
335521|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
335522|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
335523|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
335524|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
335525|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
335526|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
335527|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
335528|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
335569|NCT01156675|O3|Outcome|No Treatment|Not treated with FLEXUS or X-STOP
335530|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
335531|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
335532|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
335533|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
335534|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
335535|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
335536|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
335537|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
335538|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
335539|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
335540|NCT01156701|E4|Reported Event|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
335541|NCT01156701|E3|Reported Event|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
335542|NCT01156701|E2|Reported Event|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
335543|NCT01156701|E1|Reported Event|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
335544|NCT01156675|B4|Baseline|Total|Total of all reporting groups
335545|NCT01156675|B3|Baseline|No Treatment|Not treated with FLEXUS or X-STOP
335546|NCT01156675|B2|Baseline|X-STOP® Interspinous Spacer|X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the X-STOP® Spacer
335547|NCT01156675|B1|Baseline|FLEXUS™ Interspinous Spacer|FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
335548|NCT01156675|P3|Participant Flow|No Treatment|Not treated with FLEXUS or X-STOP
335549|NCT01156675|P2|Participant Flow|X-STOP® Interspinous Spacer|X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the XSTOP® Spacer
335550|NCT01156675|P1|Participant Flow|FLEXUS™ Interspinous Spacer|FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
335551|NCT01156675|O3|Outcome|No Treatment|Not treated with FLEXUS or X-STOP
335552|NCT01156675|O2|Outcome|XSTOP® Interspinous Spacer|XSTOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the XSTOP® Spacer
335553|NCT01156675|O1|Outcome|FLEXUS™ Interspinous Spacer|FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
335554|NCT01156675|O3|Outcome|No Treatment|Not treated with FLEXUS or X-STOP
335555|NCT01156675|O2|Outcome|X-STOP® Interspinous Spacer|X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the XSTOP® Spacer
335556|NCT01156675|O1|Outcome|FLEXUS™ Interspinous Spacer|FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
335557|NCT01156675|O3|Outcome|No Treatment|Not treated with FLEXUS or X-STOP
335558|NCT01156675|O2|Outcome|X-STOP® Interspinous Spacer|X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the XSTOP® Spacer
335559|NCT01156675|O1|Outcome|FLEXUS™ Interspinous Spacer|FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
335560|NCT01156675|O3|Outcome|No Treatment|Not treated with FLEXUS or X-STOP
335561|NCT01156675|O2|Outcome|X-STOP® Interspinous Spacer|X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the XSTOP® Spacer
335562|NCT01156675|O1|Outcome|FLEXUS™ Interspinous Spacer|FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
335563|NCT01156675|O3|Outcome|No Treatment|Not treated with FLEXUS or X-STOP
335564|NCT01156675|O2|Outcome|X-STOP® Interspinous Spacer|X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the XSTOP® Spacer
335565|NCT01156675|O1|Outcome|FLEXUS™ Interspinous Spacer|FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
350811|NCT01119950|E8|Reported Event|Placebo|Placebo
335570|NCT01156675|O2|Outcome|X-STOP® Interspinous Spacer|X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the XSTOP® Spacer
335571|NCT01156675|O1|Outcome|FLEXUS™ Interspinous Spacer|FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
335572|NCT01156675|O3|Outcome|No Treatment|Not treated with FLEXUS or X-STOP
335573|NCT01156675|O2|Outcome|X-STOP® Interspinous Spacer|X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the XSTOP® Spacer
335574|NCT01156675|O1|Outcome|FLEXUS™ Interspinous Spacer|FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
335575|NCT01156675|E3|Reported Event|No Treatment|Not treated with FLEXUS or X-STOP
335576|NCT01156675|E2|Reported Event|X-STOP® Interspinous Spacer|X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the X-STOP® Spacer
335577|NCT01156675|E1|Reported Event|FLEXUS™ Interspinous Spacer|FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
335578|NCT01156597|B3|Baseline|Total|Total of all reporting groups
335579|NCT01156597|B2|Baseline|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
335580|NCT01156597|B1|Baseline|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level~The pioglitazone treatment regimen for this arm of the study: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
335581|NCT01156597|P2|Participant Flow|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
335582|NCT01156597|P1|Participant Flow|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level~pioglitazone: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
335583|NCT01156597|O2|Outcome|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
335584|NCT01156597|O1|Outcome|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level~The pioglitazone treatment regimen for this arm of the study: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
335585|NCT01156597|O2|Outcome|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
335586|NCT01156597|O1|Outcome|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level~pioglitazone: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
335587|NCT01156597|O2|Outcome|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
335588|NCT01156597|O1|Outcome|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level~The pioglitazone treatment regimen for this arm of the study: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
335589|NCT01156597|E2|Reported Event|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
335590|NCT01156597|E1|Reported Event|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level~pioglitazone: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
335591|NCT01156571|B3|Baseline|Total|Total of all reporting groups
335592|NCT01156571|B2|Baseline|Clopidogrel Treatment Arm|"Oral clopidogrel was administered as soon as possible following randomization at investigator discretion at a loading dose of either 600 mg or 300 mg as specified by the investigator.~Patients in the clopidogrel treatment arm received IV placebo for 2 hours or end of the PCI procedure, whichever was longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.~At the end of IV placebo infusion, patients were given oral placebo capsules matching the oral clopidogrel transition dose."
335593|NCT01156571|B1|Baseline|Cangrelor Treatment Arm|"Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.~Immediately after discontinuation of infusion, an oral transition dose of clopidogrel 600 mg was administered.~Patients also received oral placebo capsules, administered as soon as possible following randomization at investigator discretion. These capsules were designed to match the clopidogrel 600 mg or 300 mg loading dose."
335594|NCT01156571|P2|Participant Flow|Clopidogrel Treatment Arm|"Oral clopidogrel was administered as soon as possible following randomization at investigator discretion at a loading dose of either 600 mg or 300 mg as specified by the investigator.~Patients in the clopidogrel treatment arm received IV placebo for 2 hours or end of the PCI procedure, whichever was longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.~At the end of IV placebo infusion, patients were given oral placebo capsules matching the oral clopidogrel transition dose."
335654|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335655|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335656|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335595|NCT01156571|P1|Participant Flow|Cangrelor Treatment Arm|"Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.~Immediately after discontinuation of infusion, an oral transition dose of clopidogrel 600 mg was administered.~Patients also received oral placebo capsules, administered as soon as possible following randomization at investigator discretion. These capsules were designed to match the clopidogrel 600 mg or 300 mg loading dose."
335596|NCT01156571|O2|Outcome|Clopidogrel Treatment Arm|
335597|NCT01156571|O1|Outcome|Cangrelor Treatment Arm|
335598|NCT01156571|O2|Outcome|Clopidogrel Treatment Arm|
335599|NCT01156571|O1|Outcome|Cangrelor Treatment Arm|
335600|NCT01156571|O2|Outcome|Clopidogrel Treatment Arm|
335601|NCT01156571|O1|Outcome|Cangrelor Treatment Arm|
335602|NCT01156571|E2|Reported Event|Clopidogrel Treatment Arm|
335603|NCT01156571|E1|Reported Event|Cangrelor Treatment Arm|
335604|NCT01156532|B1|Baseline|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
335605|NCT01156532|P1|Participant Flow|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
335606|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
335607|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
335608|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
335609|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
335610|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
335611|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
335612|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
335613|NCT01156532|E1|Reported Event|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
335614|NCT01156480|B3|Baseline|Total|Total of all reporting groups
335615|NCT01156480|B2|Baseline|Placebo|Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
335616|NCT01156480|B1|Baseline|Hydrocortisone|Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
335617|NCT01156480|P2|Participant Flow|Placebo|Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
335657|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335658|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335618|NCT01156480|P1|Participant Flow|Hydrocortisone|hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous route for 3 days, then 2mg/kg/day divided every 8 hours IV for 1 day, then 1.5mg/kg/day divided every 8 hours IV for 1 day, then 1mg/kg/day divided every 12 hours for 1 day, then 0.5mg/kg/day in single dose for one day. Placebo group will receive equal volume of placebo on the same schedule. The first dose of study drug will be given within 6 hours of NEC diagnosis, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
335619|NCT01156480|O2|Outcome|Placebo|Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
335620|NCT01156480|O1|Outcome|Hydrocortisone|Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
335621|NCT01156480|O2|Outcome|Placebo|Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
335622|NCT01156480|O1|Outcome|Hydrocortisone|Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
335623|NCT01156480|E2|Reported Event|Placebo|Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
335624|NCT01156480|E1|Reported Event|Hydrocortisone|Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
335625|NCT01156376|B4|Baseline|Total|Total of all reporting groups
335626|NCT01156376|B3|Baseline|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335627|NCT01156376|B2|Baseline|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335628|NCT01156376|B1|Baseline|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335629|NCT01156376|P3|Participant Flow|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335630|NCT01156376|P2|Participant Flow|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335631|NCT01156376|P1|Participant Flow|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335632|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335633|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335634|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335635|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335636|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335637|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335638|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335639|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335640|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335641|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335642|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335643|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335644|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335645|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335646|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335647|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335648|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335649|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335650|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335651|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335652|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335653|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335664|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335665|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335666|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335667|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335668|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335669|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335670|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335671|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335672|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335673|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335674|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335675|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335676|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335677|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335678|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335679|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335680|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335681|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335682|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335683|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335684|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335685|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335686|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335687|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335688|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335689|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335690|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335691|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335692|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335693|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335694|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335695|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335696|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335697|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335698|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335699|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335700|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335701|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335702|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335703|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335704|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335705|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335706|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335707|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335708|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335709|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335710|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335711|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335712|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335713|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335714|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335715|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335716|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335717|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335718|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335719|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335720|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335721|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335722|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335723|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335724|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335725|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335726|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335727|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335728|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335729|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335730|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335731|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335732|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335733|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335734|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335735|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335736|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335737|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335738|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335739|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335740|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335741|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335742|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335743|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335744|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335745|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335746|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335747|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335748|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335749|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335750|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335751|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335752|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335753|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335754|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335755|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335756|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335757|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335758|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335759|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335760|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335761|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335762|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335763|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335764|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335765|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335766|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335767|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335768|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335769|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335770|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335771|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335772|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335773|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335774|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335775|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335776|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335777|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335778|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335779|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335780|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335781|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335782|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335783|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335784|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335785|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335786|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335787|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335788|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335789|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335790|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335791|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335792|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335793|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335794|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335795|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335796|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335797|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335798|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335799|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335800|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335801|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335802|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335803|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335804|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335805|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335806|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335807|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335808|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335809|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335810|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335811|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335812|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335813|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335814|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335815|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335816|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335817|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335818|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335819|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335820|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335821|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335822|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335823|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335824|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335825|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335826|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335827|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335828|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335829|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335830|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335831|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335832|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335833|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335834|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335835|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335836|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335837|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335838|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335839|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335840|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335841|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335842|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335843|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335844|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335845|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335846|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335847|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335848|NCT01156376|E3|Reported Event|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
335849|NCT01156376|E2|Reported Event|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
335850|NCT01156376|E1|Reported Event|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
335851|NCT01156363|B1|Baseline|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at all 3 centers."
335852|NCT01156363|P1|Participant Flow|Mircera|"Participants received Mircera (epoetin beta-methoxy polyethylene glycol) 80, 120, 200, or 360 micrograms (mcg) (based on the weekly dose of erythropoiesis stimulating agent [ESA] participant received in the week preceding the switch to Mircera [Week -1]) by intravenous (IV) or subcutaneous (SC) injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on hemoglobin (Hb) level.~This arm includes participants enrolled at all 3 centers."
335853|NCT01156363|O1|Outcome|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at all 3 centers."
335854|NCT01156363|O4|Outcome|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at all 3 centers."
335855|NCT01156363|O3|Outcome|Mircera - BTCH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at Buddhist Tzu Chi General Hospital (BTCH)."
335856|NCT01156363|O2|Outcome|Mircera – KMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)."
335857|NCT01156363|O1|Outcome|Mircera – CMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at China Medical University Hospital (CMUH)."
335858|NCT01156363|O4|Outcome|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at all 3 centers."
335859|NCT01156363|O3|Outcome|Mircera - BTCH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at BTCH."
335860|NCT01156363|O2|Outcome|Mircera – KMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at KMUH."
335861|NCT01156363|O1|Outcome|Mircera – CMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at CMUH."
335862|NCT01156363|O4|Outcome|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at all 3 centers."
335863|NCT01156363|O3|Outcome|Mircera - BTCH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at BTCH."
335864|NCT01156363|O2|Outcome|Mircera – KMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at KMUH."
335865|NCT01156363|O1|Outcome|Mircera – CMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at CMUH."
335866|NCT01156363|O4|Outcome|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at all 3 centers."
335867|NCT01156363|O3|Outcome|Mircera - BTCH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at Buddhist Tzu Chi General Hospital (BTCH)."
335868|NCT01156363|O2|Outcome|Mircera – KMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)."
335869|NCT01156363|O1|Outcome|Mircera – CMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at China Medical University Hospital (CMUH)."
335870|NCT01156363|E1|Reported Event|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at all 3 centers."
335871|NCT01156311|B3|Baseline|Total|Total of all reporting groups
335872|NCT01156311|B2|Baseline|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
335873|NCT01156311|B1|Baseline|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
335874|NCT01156311|P4|Participant Flow|Add-on Therapy Period: Dimethyl Fumarate Add-on to GA|"Dimethyl fumarate was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).~Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study."
335875|NCT01156311|P3|Participant Flow|Add-on Therapy Period: Dimethyl Fumarate Add-on to IFNß|"BG00012 (dimethyl fumarate) was to be administered at 120 mg three times a day (TID) on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months) as an add-on to a stable dose of IFNß.~Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study."
335876|NCT01156311|P2|Participant Flow|Monotherapy Period: Glatiramer Acetate (GA)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. The monotherapy period included the 8 weeks prior to the first dose of dimethyl fumarate.
335877|NCT01156311|P1|Participant Flow|Monotherapy Period: Interferon Beta (IFNß)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. The monotherapy period included the 8 weeks prior to the first dose of dimethyl fumarate.
335878|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
335879|NCT01156311|O1|Outcome|Interferon Beta 1a (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
335880|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
335881|NCT01156311|O1|Outcome|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
335882|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
335883|NCT01156311|O1|Outcome|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
335884|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
335885|NCT01156311|O1|Outcome|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
335886|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
335887|NCT01156311|O1|Outcome|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
336429|NCT01154816|E10|Reported Event|Recurrent Childhood Acute Lympohblastic Leukemia|Experimental: Arm 10
335888|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
335889|NCT01156311|O1|Outcome|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
335890|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
335891|NCT01156311|O1|Outcome|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
335892|NCT01156311|O2|Outcome|Monotherapy Period: GA|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. The monotherapy period included the 8 weeks prior to the first dose of dimethyl fumarate.
335893|NCT01156311|O1|Outcome|Monotherapy Period: IFNß|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. The monotherapy period included the 8 weeks prior to the first dose of dimethyl fumarate.
335894|NCT01156311|E4|Reported Event|Add-on Therapy Period: GA and BG00012|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
335895|NCT01156311|E3|Reported Event|Add-on Therapy Period: IFNß and BG00012|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
335896|NCT01156311|E2|Reported Event|Monotherapy Period: GA|A stable dose of GA for up to 8 weeks (until the first dose of BG00012).
335897|NCT01156311|E1|Reported Event|Monotherapy Period: IFNß|A stable dose of one of the IFNß products for up to 8 weeks (until the first dose of BG00012).
335898|NCT01156142|B3|Baseline|Total|Total of all reporting groups
335899|NCT01156142|B2|Baseline|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
335900|NCT01156142|B1|Baseline|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
335901|NCT01156142|P2|Participant Flow|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
335902|NCT01156142|P1|Participant Flow|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
335903|NCT01156142|O2|Outcome|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
335904|NCT01156142|O1|Outcome|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
335905|NCT01156142|O2|Outcome|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
335906|NCT01156142|O1|Outcome|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
335907|NCT01156142|O2|Outcome|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
335908|NCT01156142|O1|Outcome|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
335909|NCT01156142|O2|Outcome|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
335910|NCT01156142|O1|Outcome|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
335911|NCT01156142|O2|Outcome|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
335912|NCT01156142|O1|Outcome|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
335913|NCT01156142|O2|Outcome|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
335914|NCT01156142|O1|Outcome|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
335915|NCT01156142|E2|Reported Event|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
335916|NCT01156142|E1|Reported Event|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
335917|NCT01156116|B3|Baseline|Total|Total of all reporting groups
335918|NCT01156116|B2|Baseline|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
335919|NCT01156116|B1|Baseline|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
335920|NCT01156116|P2|Participant Flow|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
335921|NCT01156116|P1|Participant Flow|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
335922|NCT01156116|O2|Outcome|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
335923|NCT01156116|O1|Outcome|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
335924|NCT01156116|O2|Outcome|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
335925|NCT01156116|O1|Outcome|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
335926|NCT01156116|O2|Outcome|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
335927|NCT01156116|O1|Outcome|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
335928|NCT01156116|O2|Outcome|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
335929|NCT01156116|O1|Outcome|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
335930|NCT01156116|E2|Reported Event|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
335931|NCT01156116|E1|Reported Event|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
335932|NCT01156051|B3|Baseline|Total|Total of all reporting groups
335933|NCT01156051|B2|Baseline|Placebo Comparator|"Placebo control~Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg were started and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
335934|NCT01156051|B1|Baseline|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg~Guanfacine extended-release tablets: Guanfacine extended-release tablets were started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
335935|NCT01156051|P2|Participant Flow|Control|Children who received a matching placebo tablet administered once daily in the morning in a flexible dosing protocol, with tablets identical to guanfacine extended release from 1mg to 4mg.
335936|NCT01156051|P1|Participant Flow|Treatment Group|Children who received (double blinded, randomized) guanfacine extended release tablets in a flexible dosing protocol, with doses ranging from 1mg to 4mg administered once daily in the morning.
335937|NCT01156051|O2|Outcome|Placebo Comparator|"Placebo control~Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine)."
335938|NCT01156051|O1|Outcome|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg~Guanfacine extended-release tablets: Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
335939|NCT01156051|O2|Outcome|Placebo Comparator|"Placebo control~Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine)."
335940|NCT01156051|O1|Outcome|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg~Guanfacine extended-release tablets: Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
335941|NCT01156051|O2|Outcome|Placebo Comparator|"Placebo control~Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine)."
335942|NCT01156051|O1|Outcome|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg~Guanfacine extended-release tablets: Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
335943|NCT01156051|O2|Outcome|Placebo Comparator|"Placebo control~Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine)."
335994|NCT01155726|P3|Participant Flow|Etafilcon A, Masked, Unmasked|Etafilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, unmasked) in Period 2.
335944|NCT01156051|O1|Outcome|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg~Guanfacine extended-release tablets: Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
335945|NCT01156051|E2|Reported Event|Placebo Comparator|"Placebo control~Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine)."
335946|NCT01156051|E1|Reported Event|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg~Guanfacine extended-release tablets: Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
335947|NCT01156012|B3|Baseline|Total|Total of all reporting groups
335948|NCT01156012|B2|Baseline|Prostaglandin|"One drop of prostaglandin~Prostaglandin: One drop of prostaglandin at 9.00pm"
335949|NCT01156012|B1|Baseline|T2345|"One drop of T2345~T2345: One drop of T2345 at 9.00pm."
335950|NCT01156012|P2|Participant Flow|Prostaglandin|"One drop of prostaglandin~Prostaglandin: One drop of prostaglandin at 9.00pm"
335951|NCT01156012|P1|Participant Flow|T2345|"One drop of T2345~T2345: One drop of T2345 at 9.00pm"
335952|NCT01156012|O2|Outcome|Prostaglandin|"One drop of prostaglandin~Prostaglandin: One drop of prostaglandin at 9.00pm"
335953|NCT01156012|O1|Outcome|T2345|"One drop of T2345~T2345: One drop of T2345 at 9.00pm."
335954|NCT01156012|E2|Reported Event|Prostaglandin|"One drop of prostaglandin~Prostaglandin: One drop of prostaglandin at 9.00pm"
335955|NCT01156012|E1|Reported Event|T2345|"One drop of T2345~T2345: One drop of T2345 at 9.00pm."
335956|NCT01155999|B3|Baseline|Total|Total of all reporting groups
335957|NCT01155999|B2|Baseline|Tobramycin|Tobramycin: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6
335958|NCT01155999|B1|Baseline|T1225|T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
335959|NCT01155999|P2|Participant Flow|Tobramycin|Tobramycin: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6
335960|NCT01155999|P1|Participant Flow|T1225|T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
335961|NCT01155999|O2|Outcome|Tobramycin|Tobramycin: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6
335962|NCT01155999|O1|Outcome|T1225|T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
335963|NCT01155999|E2|Reported Event|Tobramycin|Tobramycin: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6
335964|NCT01155999|E1|Reported Event|T1225|T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
335965|NCT01155869|B3|Baseline|Total|Total of all reporting groups
335966|NCT01155869|B2|Baseline|Oral Naltrexone|Naltrexone 50 mg tablet PO daily
335967|NCT01155869|B1|Baseline|XR-NTX|Depot naltrexone (Vivitrol) 380 mg. IM monthly
335968|NCT01155869|P2|Participant Flow|Oral Naltrexone|Naltrexone 50 mg tablet PO daily
335969|NCT01155869|P1|Participant Flow|XR-NTX|Depot naltrexone (Vivitrol) 380 mg. IM monthly
335970|NCT01155869|O2|Outcome|Oral Naltrexone|Naltrexone 50 mg tablet PO daily
335971|NCT01155869|O1|Outcome|XR-NTX|Depot naltrexone (Vivitrol) 380 mg. IM monthly
335972|NCT01155869|O2|Outcome|Oral Naltrexone|Naltrexone 50 mg tablet PO daily
335973|NCT01155869|O1|Outcome|XR-NTX|Depot naltrexone (Vivitrol) 380 mg. IM monthly
335974|NCT01155869|E2|Reported Event|Oral Naltrexone|Naltrexone 50 mg tablet PO daily
335975|NCT01155869|E1|Reported Event|XR-NTX|Depot naltrexone (Vivitrol) 380 mg. IM monthly
335976|NCT01155830|B4|Baseline|Total|Total of all reporting groups
335977|NCT01155830|B3|Baseline|Infants Treated With ECMO|Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
335978|NCT01155830|B2|Baseline|Infants With Sepsis|Infants who are culture positive for sepsis and require vasopressor support
335979|NCT01155830|B1|Baseline|Infants With CHD|Infants with Congenital Diaphragmatic Hernia (CHD)
335980|NCT01155830|P3|Participant Flow|Infants Treated With ECMO|Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
335981|NCT01155830|P2|Participant Flow|Infants With Sepsis|Infants who are culture positive for sepsis and require vasopressor support
335982|NCT01155830|P1|Participant Flow|Infants With CHD|Infants with Congenital Diaphragmatic Hernia (CHD)
335983|NCT01155830|O3|Outcome|Infants Treated With ECMO|Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
335984|NCT01155830|O2|Outcome|Infants With Sepsis|Infants who are culture positive for sepsis and require vasopressor support
335985|NCT01155830|O1|Outcome|Infants With CHD|Infants with Congenital Diaphragmatic Hernia (CHD)
335986|NCT01155830|O3|Outcome|Infants Treated With ECMO|Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
335987|NCT01155830|O2|Outcome|Infants With Sepsis|Infants who are culture positive for sepsis and require vasopressor support
335988|NCT01155830|O1|Outcome|Infants With CHD|Infants with Congenital Diaphragmatic Hernia (CHD)
335989|NCT01155830|E3|Reported Event|Infants Treated With ECMO|Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
335990|NCT01155830|E2|Reported Event|Infants With Sepsis|Infants who are culture positive for sepsis and require vasopressor support
335991|NCT01155830|E1|Reported Event|Infants With CHD|Infants with Congenital Diaphragmatic Hernia (CHD)
335992|NCT01155726|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed participants.
335993|NCT01155726|P4|Participant Flow|Etafilcon A, Masked, Partially Masked|Etafilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, partially masked) in Period 2.
337414|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
335995|NCT01155726|P2|Participant Flow|Nelfilcon A, Masked, Partially Masked|Nelfilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, partially masked) in Period 2.
335996|NCT01155726|P1|Participant Flow|Nelfilcon A, Masked, Unmasked|Nelfilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, unmasked) in Period 2.
335997|NCT01155726|O16|Outcome|Etafilcon A, Pd 1 Masked, Pd 2 Partial (DACP)|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
335998|NCT01155726|O15|Outcome|Etafilcon A, Pd 1 Masked, Pd 2 Partial (1DAVM)|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
335999|NCT01155726|O14|Outcome|Nelfilcon A, Pd 1 Masked, Pd 2 Partial (DACP)|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
336000|NCT01155726|O13|Outcome|Nelfilcon A, Pd 1 Masked, Pd 2 Partial (1DAVM)|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
336001|NCT01155726|O12|Outcome|Etafilcon A, Pd 1 Masked (DACP), Pd 2 Partial|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
336002|NCT01155726|O11|Outcome|Etafilcon A, Pd 1 Masked (1DAVM), Pd 2 Partial|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
336003|NCT01155726|O10|Outcome|Nelfilcon A, Pd 1 Masked (DACP), Pd 2 Partial|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
336004|NCT01155726|O9|Outcome|Nelfilcon A, Pd 1 Masked (1DAVM), Pd 2 Partial|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
336005|NCT01155726|O8|Outcome|Etafilcon A, Pd 1 Masked, Pd 2 Unmasked (DACP)|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
336006|NCT01155726|O7|Outcome|Etafilcon A, Pd 1 Masked, Pd 2 Unmasked (1DAVM)|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
336007|NCT01155726|O6|Outcome|Nelfilcon A, Pd 1 Masked, Pd 2 Unmasked (DACP)|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
336008|NCT01155726|O5|Outcome|Nelfilcon A, Pd 1 Masked, Pd 2 Unmasked (1DAVM)|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
336009|NCT01155726|O4|Outcome|Etafilcon A, Pd 1 Masked (DACP), Pd 2 Unmasked|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
336010|NCT01155726|O3|Outcome|Etafilcon A, Pd 1 Masked (1DAVM), Pd 2 Unmasked|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
336011|NCT01155726|O2|Outcome|Nelfilcon A, Pd 1 Masked (DACP), Pd 2 Unmasked|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
336012|NCT01155726|O1|Outcome|Nelfilcon A, Pd 1 Masked (1DAVM), Pd 2 Unmasked|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
336013|NCT01155726|E4|Reported Event|DACP|Nelfilcon A with comfort additive contact lenses
336014|NCT01155726|E3|Reported Event|1DAVM|Etafilcon A with comfort additive contact lenses
336015|NCT01155726|E2|Reported Event|Etafilcon A|Etafilcon A contact lenses
336016|NCT01155726|E1|Reported Event|Nelfilcon A|Nelfilcon A contact lenses
336017|NCT01155661|B1|Baseline|LY2216684 + SSRI|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
336018|NCT01155661|P1|Participant Flow|LY2216684 + SSRI|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
336019|NCT01155661|O1|Outcome|LY2216684 + SSRI|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
336020|NCT01155661|O1|Outcome|LY2216684 + SSRI|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
336021|NCT01155661|O1|Outcome|LY2216684 + SSRI|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
336022|NCT01155661|O1|Outcome|LY2216684 + SSRI|LY2216684: 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
336023|NCT01155661|O1|Outcome|LY2216684 + SSRI|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
336024|NCT01155661|O1|Outcome|LY2216684 + SSRI|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
336025|NCT01155661|O1|Outcome|LY2216684 + SSRI|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
336026|NCT01155661|O1|Outcome|LY2216684 + SSRI|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
336027|NCT01155661|O1|Outcome|LY2216684 + SSRI|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
336028|NCT01155661|O1|Outcome|LY2216684 + SSRI|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
336029|NCT01155661|O1|Outcome|LY2216684 + SSRI|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
336030|NCT01155661|O1|Outcome|LY2216684 + SSRI|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
351119|NCT01119755|E1|Reported Event|Group 1|
336031|NCT01155661|O1|Outcome|LY2216684 + SSRI|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
336032|NCT01155661|O1|Outcome|LY2216684 + SSRI|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
336033|NCT01155661|O1|Outcome|LY2216684 + SSRI|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
336034|NCT01155661|O1|Outcome|LY2216684 + SSRI|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
336035|NCT01155661|O1|Outcome|LY2216684 + SSRI|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
336036|NCT01155661|O1|Outcome|LY2216684 + SSRI|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
336037|NCT01155661|O1|Outcome|LY2216684 + SSRI|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
336038|NCT01155661|O1|Outcome|LY2216684 + SSRI|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
336039|NCT01155661|O1|Outcome|LY2216684 + SSRI|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
336040|NCT01155661|O1|Outcome|LY2216684 + SSRI|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
336041|NCT01155661|E2|Reported Event|Discontinuation Phase|Included all enrolled participants who abruptly discontinued LY2216684 (edivoxetine) treatment either at the end of the study or after early withdrawal from the study and who did not discontinue from the study for the reason 'Lost to follow-up' at the discontinuation phase visit. All participants maintained their SSRI treatment at the stable dose during the discontinuation phase.
336042|NCT01155661|E1|Reported Event|LY2216684 + SSRI Open-Label Phase|LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI); included all enrolled participants who did not discontinue from the study for the reason 'Lost to follow-up' at the first post-baseline visit.
336043|NCT01155570|B1|Baseline|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
336044|NCT01155570|P1|Participant Flow|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
336045|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
336046|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
336047|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
336048|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
336049|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
336050|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
336051|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
336052|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
336053|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
336054|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
336055|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
336056|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
336057|NCT01155570|O2|Outcome|Humira (Adalimumab-naive Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
336058|NCT01155570|O1|Outcome|Humira (All Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
336059|NCT01155570|O2|Outcome|Humira (Adalimumab-naive Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
336060|NCT01155570|O1|Outcome|Humira (All Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
336061|NCT01155570|O2|Outcome|Humira (Adalimumab-naive Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
336062|NCT01155570|O1|Outcome|Humira (All Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
336063|NCT01155570|O2|Outcome|Humira (Adalimumab-naive Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
336064|NCT01155570|O1|Outcome|Humira (All Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
336065|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
336066|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
336067|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
336068|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
336069|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
336070|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
336071|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
336072|NCT01155570|E1|Reported Event|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
336073|NCT01155531|B5|Baseline|Total|Total of all reporting groups
336074|NCT01155531|B4|Baseline|Telenzepine Plus Sertraline - Group D|received Sertraline 150 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
336075|NCT01155531|B3|Baseline|Telenzepine Plus Sertraline - Group C|received Sertraline 100 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
336076|NCT01155531|B2|Baseline|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
336077|NCT01155531|B1|Baseline|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
336078|NCT01155531|P4|Participant Flow|Telenzepine Plus Sertraline - Group D|received Sertraline 150 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
336079|NCT01155531|P3|Participant Flow|Telenzepine Plus Sertraline - Group C|received Sertraline 100 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
336080|NCT01155531|P2|Participant Flow|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
336081|NCT01155531|P1|Participant Flow|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
336082|NCT01155531|O4|Outcome|Sertraline Plus Telenzepine - Group D|received Sertraline 150 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
336083|NCT01155531|O3|Outcome|Sertraline Plus Telenzepine - Group C|received Sertraline 100 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
336084|NCT01155531|O2|Outcome|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
336085|NCT01155531|O1|Outcome|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
336086|NCT01155531|O4|Outcome|Sertraline Plus Telenzepine - Group D|received Sertraline 150 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
336087|NCT01155531|O3|Outcome|Sertraline Plus Telenzepine - Group C|received Sertraline 100 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
336088|NCT01155531|O2|Outcome|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
336089|NCT01155531|O1|Outcome|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
336090|NCT01155531|O4|Outcome|Sertraline Plus Telenzepine - Group D|received Sertraline 150 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
336091|NCT01155531|O3|Outcome|Sertraline Plus Telenzepine - Group C|received Sertraline 100 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
336092|NCT01155531|O2|Outcome|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
336093|NCT01155531|O1|Outcome|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
336094|NCT01155531|E4|Reported Event|Telenzepine Plus Sertraline - Group D|received Sertraline 150 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
336095|NCT01155531|E3|Reported Event|Telenzepine Plus Sertraline - Group C|received Sertraline 100 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
336096|NCT01155531|E2|Reported Event|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
336097|NCT01155531|E1|Reported Event|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
336098|NCT01155479|B6|Baseline|Total|Total of all reporting groups
336099|NCT01155479|B5|Baseline|Rasagiline|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
336100|NCT01155479|B4|Baseline|Placebo|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1); preladenant 5 mg was taken twice daily for 26 weeks (Part 2).
336101|NCT01155479|B3|Baseline|Preladenant 10 mg|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
336102|NCT01155479|B2|Baseline|Preladenant 5 mg|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
336430|NCT01154816|E9|Reported Event|Recurrent Wilms Tumor and Other Childhood Kidney Tumors|Experimental: Arm 9
336103|NCT01155479|B1|Baseline|Preladenant 2 mg|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
336104|NCT01155479|P5|Participant Flow|Rasagiline|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
336105|NCT01155479|P4|Participant Flow|Placebo|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1); preladenant 5 mg was taken twice daily for 26 weeks (Part 2).
336106|NCT01155479|P3|Participant Flow|Preladenant 10 mg|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
336107|NCT01155479|P2|Participant Flow|Preladenant 5 mg|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
336108|NCT01155479|P1|Participant Flow|Preladenant 2 mg|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
336109|NCT01155479|O5|Outcome|Rasagiline (Part 2)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
336110|NCT01155479|O4|Outcome|Placebo (Part 2)|Participants who had received placebo to preladenant in Part 1 received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
336111|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 2)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
336112|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 2)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
336113|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 2)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
336114|NCT01155479|O5|Outcome|Rasagiline (Part 2)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
336115|NCT01155479|O4|Outcome|Placebo (Part 2)|Participants who had received placebo to preladenant in Part 1 received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
336116|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 2)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
336117|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 2)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
336118|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 2)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
336119|NCT01155479|O5|Outcome|Rasagiline (Part 1)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
336120|NCT01155479|O4|Outcome|Placebo (Part 1)|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
336121|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 1)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
336122|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 1)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
336123|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 1)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
336124|NCT01155479|O5|Outcome|Rasagiline (Part 1)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
336125|NCT01155479|O4|Outcome|Placebo (Part 1)|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
336126|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 1)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
336127|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 1)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
336128|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 1)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
336129|NCT01155479|O5|Outcome|Rasagiline (Part 1)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
336130|NCT01155479|O4|Outcome|Placebo (Part 1)|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
336131|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 1)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
336132|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 1)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
336133|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 1)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
336134|NCT01155479|O5|Outcome|Rasagiline (Part 1)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks. The number of participants analyzed (195) represents the number of randomized and treated participants with at least one post-treatment value.
336170|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
336135|NCT01155479|O4|Outcome|Placebo (Part 1)|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks. The number of participants analyzed (195) represents the number of randomized and treated participants with at least one post-treatment value.
336136|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 1)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks. The number of participants analyzed (200) represents the number of randomized and treated participants with at least one post-treatment value.
336137|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 1)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks. The number of participants analyzed (202) represents the number of randomized and treated participants with at least one post-treatment value.
336138|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 1)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks. The number of participants analyzed (195) represents the number of randomized and treated participants with at least one post-treatment value.
336139|NCT01155479|O5|Outcome|Rasagiline (Part 1)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
336140|NCT01155479|O4|Outcome|Placebo (Part 1)|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
336141|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 1)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
336142|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 1)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
336143|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 1)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
336144|NCT01155479|E10|Reported Event|Rasagiline - Part 2|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 2).
336145|NCT01155479|E9|Reported Event|Placebo/Preladenant 5 Mg-Part 2|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg oral tablet in the PM for 26 weeks (Part 2).
336146|NCT01155479|E8|Reported Event|Preladenant 10 mg - Part 2|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 2).
336147|NCT01155479|E7|Reported Event|Preladenant 5 mg - Part 2|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 2).
336148|NCT01155479|E6|Reported Event|Preladenant 2 mg - Part 2|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 2).
336149|NCT01155479|E5|Reported Event|Rasagiline - Part 1|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1).
336150|NCT01155479|E4|Reported Event|Placebo - Part 1|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1).
336151|NCT01155479|E3|Reported Event|Preladenant 10 mg - Part 1|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1).
336152|NCT01155479|E2|Reported Event|Preladenant 5 mg - Part 1|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1).
336153|NCT01155479|E1|Reported Event|Preladenant 2 mg - Part 1|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1).
336154|NCT01155466|B6|Baseline|Total|Total of all reporting groups
336155|NCT01155466|B5|Baseline|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
336156|NCT01155466|B4|Baseline|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
336157|NCT01155466|B3|Baseline|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
336158|NCT01155466|B2|Baseline|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
336159|NCT01155466|B1|Baseline|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
336160|NCT01155466|P5|Participant Flow|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
336161|NCT01155466|P4|Participant Flow|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
336162|NCT01155466|P3|Participant Flow|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
336163|NCT01155466|P2|Participant Flow|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
336164|NCT01155466|P1|Participant Flow|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
336165|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
336166|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
336167|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
336168|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
336169|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
336171|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
336172|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
336173|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
336174|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
336175|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
336176|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
336177|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
336178|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
336179|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
336180|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
336181|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
336182|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
336183|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
336184|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
336185|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
336186|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
336187|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
336188|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
336189|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
336190|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
336191|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
336192|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
336193|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
336194|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
336195|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
336196|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
336197|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
336198|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
336199|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
336200|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
336201|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
336202|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
336203|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
336204|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
336205|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
336206|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
336207|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
336208|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
336209|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
336210|NCT01155466|E5|Reported Event|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
336211|NCT01155466|E4|Reported Event|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
336212|NCT01155466|E3|Reported Event|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
336213|NCT01155466|E2|Reported Event|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
336214|NCT01155466|E1|Reported Event|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
336215|NCT01155388|B3|Baseline|Total|Total of all reporting groups
336216|NCT01155388|B2|Baseline|Oral Iron|Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
336217|NCT01155388|B1|Baseline|Ferumoxytol|"Participants received 1 of the following 2 ferumoxytol dose regimens:~Four IV injections of ferumoxytol 3.5 mg Fe/kg (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). *Participants participating in PK sampling received the second dose on Day 4 after the 72-hour PK sample was collected.~Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9."
336218|NCT01155388|P2|Participant Flow|Oral Iron|Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
336219|NCT01155388|P1|Participant Flow|Ferumoxytol|"Participants received 1 of the following 2 ferumoxytol dose regimens:~Four intravenous (IV) injections of ferumoxytol 3.5 milligrams (mg) iron (Fe)/kilogram (kg) (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). *Participants participating in pharmacokinetic (PK) sampling received the second dose on Day 4 after the 72-hour PK sample was collected.~Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9."
336220|NCT01155388|O2|Outcome|Oral Iron|Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
336221|NCT01155388|O1|Outcome|Ferumoxytol|"Participants received 1 of the following 2 ferumoxytol dose regimens:~Four IV injections of ferumoxytol 3.5 mg Fe/kg (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). *Participants participating in PK sampling received the second dose on Day 4 after the 72-hour PK sample was collected.~Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9."
336222|NCT01155388|O2|Outcome|Oral Iron|Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
336223|NCT01155388|O1|Outcome|Ferumoxytol|"Participants received 1 of the following 2 ferumoxytol dose regimens:~Four IV injections of ferumoxytol 3.5 mg Fe/kg (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). *Participants participating in PK sampling received the second dose on Day 4 after the 72-hour PK sample was collected.~Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9"
336224|NCT01155388|E2|Reported Event|Oral Iron|Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
336225|NCT01155388|E1|Reported Event|Ferumoxytol|"Participants received 1 of the following 2 ferumoxytol dose regimens:~Four IV injections of ferumoxytol 3.5 mg Fe/kg (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). *Participants participating in PK sampling received the second dose on Day 4 after the 72-hour PK sample was collected.~Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9."
336226|NCT01155375|B3|Baseline|Total|Total of all reporting groups
336227|NCT01155375|B2|Baseline|Oral Iron|Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
336228|NCT01155375|B1|Baseline|Ferumoxytol|"Participants received 1 of the following 2 ferumoxytol dose regimens:~Four IV injections of ferumoxytol 3.5 mg Fe/kg (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). *Participants participating in PK sampling received the second dose on Day 4 after the 72-hour PK sample was collected.~Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9."
336229|NCT01155375|P2|Participant Flow|Oral Iron|Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
336230|NCT01155375|P1|Participant Flow|Ferumoxytol|"Participants received 1 of the following 2 ferumoxytol dose regimens:~Four intravenous (IV) injections of ferumoxytol 3.5 milligrams (mg) iron (Fe)/kilogram (kg) (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4).*Participants participating in pharmacokinetic (PK) sampling received the second dose on Day 4 after the 72-hour PK sample was collected.~Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9."
336231|NCT01155375|O2|Outcome|Oral Iron|Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
336232|NCT01155375|O1|Outcome|Ferumoxytol|"Participants received 1 of the following 2 ferumoxytol dose regimens:~Four IV injections of ferumoxytol 3.5 mg Fe/kg (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). *Participants participating in PK sampling received the second dose on Day 4 after the 72-hour PK sample was collected.~Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9."
336233|NCT01155375|O2|Outcome|Oral Iron|Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
336234|NCT01155375|O1|Outcome|Ferumoxytol|"Participants received 1 of the following 2 ferumoxytol dose regimens:~Four IV injections of ferumoxytol 3.5 mg Fe/kg (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4).*Participants participating in PK sampling received the second dose on Day 4 after the 72-hour PK sample was collected.~Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9."
336235|NCT01155375|E2|Reported Event|Oral Iron|Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
336236|NCT01155375|E1|Reported Event|Ferumoxytol|"Participants received 1 of the following 2 ferumoxytol dose regimens:~Four IV injections of ferumoxytol 3.5 mg Fe/kg (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). *Participants participating in PK sampling received the second dose on Day 4 after the 72-hour PK sample was collected.~Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9."
336237|NCT01155336|B3|Baseline|Total|Total of all reporting groups
336238|NCT01155336|B2|Baseline|Lovaza®|"Lovaza® is a prescription grade EPA+DHA fish oil supplement. Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~Lovaza® : Lovaza® is prescription grade EPA+DHA fish oil supplement."
336239|NCT01155336|B1|Baseline|Corn Oil|"The placebo contained 1 gram of corn oil in each capsule. Four capsules were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill"
336240|NCT01155336|P2|Participant Flow|Lovaza®|"Lovaza® is a prescription grade EPA+DHA fish oil supplement. Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~Lovaza® : Lovaza® is prescription grade EPA+DHA fish oil supplement."
336241|NCT01155336|P1|Participant Flow|Corn Oil|"The placebo contained 1 gram of corn oil in each capsule. Four capsules were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill"
336242|NCT01155336|O2|Outcome|Lovaza®|"Lovaza® is a prescription grade EPA+DHA fish oil supplement. Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~Lovaza® : Lovaza® is prescription grade EPA+DHA fish oil supplement."
336243|NCT01155336|O1|Outcome|Corn Oil|"The placebo contained 1 gram of corn oil in each capsule. Four capsules were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill"
336244|NCT01155336|O2|Outcome|Lovaza®|"Lovaza® is a prescription grade EPA+DHA fish oil supplement. Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~Lovaza® : Lovaza® is prescription grade EPA+DHA fish oil supplement."
336245|NCT01155336|O1|Outcome|Corn Oil|"The placebo contained 1 gram of corn oil in each capsule. Four capsules were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill"
336246|NCT01155336|E2|Reported Event|Lovaza®|"Lovaza® is a prescription grade EPA+DHA fish oil supplement. Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~Lovaza® : Lovaza® is prescription grade EPA+DHA fish oil supplement."
336247|NCT01155336|E1|Reported Event|Corn Oil|"The placebo contained 1 gram of corn oil in each capsule. Four capsules were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill"
336248|NCT01155323|B1|Baseline|Total Number of Participants|This represents all subjects that completed the study minus one additional subject excluded due the discovery after study completion that the subject conflicted with exclusion criteria.
336249|NCT01155323|P2|Participant Flow|Omafilcon A/Etafilcon A|omafilcon A contact lenses will be worn first and etafilcon A contact lenses will be worn second.
336250|NCT01155323|P1|Participant Flow|Etafilcon A/Omafilcon A|etafilcon A contact lenses will be worn first and omafilcon A contact lenses will be worn second.
336251|NCT01155323|O2|Outcome|Omafilcon A|soft contact lens replaced daily, worn for one week.
336252|NCT01155323|O1|Outcome|Etafilcon A|soft contact lens replaced daily, worn for one week.
336253|NCT01155323|O2|Outcome|Omafilcon A|soft contact lens replaced daily, worn for one week.
336254|NCT01155323|O1|Outcome|Etafilcon A|soft contact lens replaced daily, worn for one week.
336255|NCT01155323|O2|Outcome|Omafilcon A|soft contact lens replaced daily, worn for one week.
336256|NCT01155323|O1|Outcome|Etafilcon A|soft contact lens replaced daily, worn for one week.
336257|NCT01155323|O2|Outcome|Omafilcon A|soft contact lens replaced daily, worn for one week.
336258|NCT01155323|O1|Outcome|Etafilcon A|soft contact lens replaced daily, worn for one week.
336259|NCT01155323|O2|Outcome|Omafilcon A|soft contact lens replaced daily, worn for one week.
336260|NCT01155323|O1|Outcome|Etafilcon A|soft contact lens replaced daily, worn for one week.
336261|NCT01155323|O2|Outcome|Omafilcon A|soft contact lens replaced daily, worn for one week.
336262|NCT01155323|O1|Outcome|Etafilcon A|soft contact lens replaced daily, worn for one week.
336263|NCT01155323|E2|Reported Event|Omafilcon A|soft contact lens replaced daily, worn for one week.
336264|NCT01155323|E1|Reported Event|Etafilcon A|soft contact lens replaced daily, worn for one week.
336265|NCT01155284|B3|Baseline|Total|Total of all reporting groups
336266|NCT01155284|B2|Baseline|Placebo|Matching placebo will be given daily for 12 months. Participants were then followed for an additional 12 months.
336267|NCT01155284|B1|Baseline|Sitagliptin and Lansoprazole|Oral Sitagliptin (100 mg for those age 18 -45 years, 50 mg for those age 11-17 years) and Lansoprazole (60 mg for those 18-45 years, 30 mg for those age 11-17 years for 12 months. Participants were then followed for an additional 12 months.
336268|NCT01155284|P2|Participant Flow|Placebo|Placebo: Matching placebo was given daily for 12 months.
336269|NCT01155284|P1|Participant Flow|Sitagliptin and Lansoprazole|Oral Sitagliptin (100 mg for those age 18 -45 years, 50 mg for those age 11-17 years) and Lansoprazole (60 mg for those 18-45 years, 30 mg for those age 11-17 years for 12 months. Participants were then followed for an additional 12 months.
336270|NCT01155284|O2|Outcome|Placebo|Matching placebo will be given daily for 12 months. Participants were then followed for an additional 12 months.
336271|NCT01155284|O1|Outcome|Sitagliptin and Lansoprazole|Oral Sitagliptin (100 mg for those age 18 -45 years, 50 mg for those age 11-17 years) and Lansoprazole (60 mg for those 18-45 years, 30 mg for those age 11-17 years for 12 months. Participants were then followed for an additional 12 months.
336272|NCT01155284|O2|Outcome|Placebo|Matching placebo will be given daily for 12 months. Subjects age 11-17 at visit 2 will take 1 capsule daily; age 18-45 will take 2 capsules daily.
336273|NCT01155284|O1|Outcome|Sitagliptin and Lansoprazole|"Sitagliptin and Lansoprazole: Sitagliptin (dispensed as 50 mg capsules)and Lansoprazole(dispensed as 30 mg capsules) given daily for 12 months.~Subjects age 11-17 years at Visit 2 will take 1 capsule once daily~Subjects age 18-45 years at Visit 2 will take 2 capsules once daily"
336274|NCT01155284|E2|Reported Event|Placebo|Matching placebo will be given daily for 12 months. Subjects age 11-17 at visit 2 will take 1 capsule daily; age 18-45 will take 2 capsules daily.
336275|NCT01155284|E1|Reported Event|Sitagliptin and Lansoprazole|"Sitagliptin and Lansoprazole: Sitagliptin (dispensed as 50 mg capsules)and Lansoprazole(dispensed as 30 mg capsules) taken for 12 months.~Subjects age 11-17 years at Visit 2 will take 1 capsule once daily~Subjects age 18-45 years at Visit 2 will take 2 capsules once daily"
336276|NCT01155219|B3|Baseline|Total|Total of all reporting groups
336277|NCT01155219|B2|Baseline|Xalatan®|"Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.~Xalatan: one drop in the conjunctival sac of each eye in the morning (84 days)."
336278|NCT01155219|B1|Baseline|Geltim LP®|"Geltim LP® 1 mg/g (0.1 % timolol maleate, without preservative) packaged in single-dose containers (unidoses); one drop in the conjunctival sac of each eye in the morning (84 days).~Geltim LP 1 mg/g: one drop in the conjunctival sac of each eye in the morning (84 days)."
336279|NCT01155219|P2|Participant Flow|Xalatan®|"Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.~Xalatan: one drop in the conjunctival sac of each eye in the morning (84 days)."
336280|NCT01155219|P1|Participant Flow|Geltim LP®|"Geltim LP® 1 mg/g (0.1 % timolol maleate, without preservative) packaged in single-dose containers (unidoses); one drop in the conjunctival sac of each eye in the morning (84 days).~Geltim LP 1 mg/g: one drop in the conjunctival sac of each eye in the morning (84 days)."
336281|NCT01155219|O2|Outcome|Xalatan®|"Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.~Xalatan: one drop in the conjunctival sac of each eye in the morning (84 days)."
336282|NCT01155219|O1|Outcome|Geltim LP®|"Geltim LP® 1 mg/g (0.1 % timolol maleate, without preservative) packaged in single-dose containers (unidoses); one drop in the conjunctival sac of each eye in the morning (84 days).~Geltim LP 1 mg/g: one drop in the conjunctival sac of each eye in the morning (84 days)."
336283|NCT01155219|E2|Reported Event|Xalatan®|"Latanoprost~One drop in the conjunctival sac of each eye in the evening"
336284|NCT01155219|E1|Reported Event|Geltim LP®|"Geltim LP® 1 mg/g (0.1 % unpreserved timolol maleate gel)~One drop in the conjunctival sac of each eye in the morning"
336285|NCT01155180|B3|Baseline|Total|Total of all reporting groups
336286|NCT01155180|B2|Baseline|Placebo|"We will start the placebo at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women~Placebo: Placebo-daily self injections for 6 months"
336287|NCT01155180|B1|Baseline|Leptin|"We will start the leptin at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women~Leptin: Hormone - daily self injections for 6 months"
336288|NCT01155180|P2|Participant Flow|Placebo|"We will start the placebo at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women~Placebo: Placebo"
336289|NCT01155180|P1|Participant Flow|Leptin|"We will start the leptin at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women~Leptin: Hormone - daily self injections for 6 months"
336290|NCT01155180|O2|Outcome|Placebo|"We will start the placebo at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women~Placebo: Placebo"
336291|NCT01155180|O1|Outcome|Leptin|"We will start the leptin at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women~Leptin: Hormone - daily self injections for 6 months"
336292|NCT01155180|E2|Reported Event|Placebo|"We will start the placebo at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women~Placebo: Placebo"
336293|NCT01155180|E1|Reported Event|Leptin|"We will start the leptin at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women~Leptin: Hormone - daily self injections for 6 months"
336294|NCT01155167|B3|Baseline|Total|Total of all reporting groups
336295|NCT01155167|B2|Baseline|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
336296|NCT01155167|B1|Baseline|Placebo|Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
336297|NCT01155167|P2|Participant Flow|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
336298|NCT01155167|P1|Participant Flow|Placebo|Two placebo topical lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
336299|NCT01155167|O2|Outcome|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
336300|NCT01155167|O1|Outcome|Placebo|Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
336301|NCT01155167|O2|Outcome|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
336338|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
336302|NCT01155167|O1|Outcome|Placebo|Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
336303|NCT01155167|O2|Outcome|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
336304|NCT01155167|O1|Outcome|Placebo|Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
336305|NCT01155167|E2|Reported Event|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
336306|NCT01155167|E1|Reported Event|Placebo|Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
336307|NCT01155154|B4|Baseline|Total|Total of all reporting groups
336308|NCT01155154|B3|Baseline|Placebo|placebo: Two placebo capsules every 6 hours for 7 days
336309|NCT01155154|B2|Baseline|Cepahlexin|cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
336310|NCT01155154|B1|Baseline|Clindamycin|"clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days~clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days"
336311|NCT01155154|P3|Participant Flow|Placebo|placebo: Two placebo capsules every 6 hours for 7 days
336312|NCT01155154|P2|Participant Flow|Cepahlexin|cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
336313|NCT01155154|P1|Participant Flow|Clindamycin|"clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days~clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days"
336314|NCT01155154|O3|Outcome|Placebo|placebo: Two placebo capsules every 6 hours for 7 days
336315|NCT01155154|O2|Outcome|Cepahlexin|cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
336316|NCT01155154|O1|Outcome|Clindamycin|"clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days~clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days"
336317|NCT01155154|E3|Reported Event|Placebo|placebo: Two placebo capsules every 6 hours for 7 days
336318|NCT01155154|E2|Reported Event|Cepahlexin|cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
336319|NCT01155154|E1|Reported Event|Clindamycin|"clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days~clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days"
336320|NCT01155141|B1|Baseline|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
336321|NCT01155141|P1|Participant Flow|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
336322|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
336323|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
336324|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
336325|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
336326|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
336327|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
336328|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
336329|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
336330|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
336331|NCT01155141|E1|Reported Event|H.P. Acthar Gel|Patients were treated with 40 units subcutaneously (SC) weekly for 2 weeks, then dose increased to 80 units SC weekly for 2 weeks followed by 80 units SC twice weekly to complete 16 weeks of therapy.
336332|NCT01155063|B1|Baseline|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
336333|NCT01155063|P1|Participant Flow|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 milligram (mg) oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
336334|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
336335|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
336336|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
336337|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
351294|NCT01119222|O2|Outcome|Morphine|Morphine 10 mg
336339|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
336340|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
336341|NCT01155063|E1|Reported Event|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
336342|NCT01155024|B1|Baseline|Entire Study Population|Includes groups randomized to receive the traditional diagnostic prosthetic socket first and the direct manufactured prosthetic socket first
336343|NCT01155024|P2|Participant Flow|Direct Manufactured Socket|Initial fitting of a direct manufactured prosthetic socket
336344|NCT01155024|P1|Participant Flow|Traditional Socket|Initial fitting of a traditional diagnostic prosthetic socket
336345|NCT01155024|O1|Outcome|Socket Preference|Participant's indicated preference of socket type (preferred traditional socket, preferred direct manufactured socket, or no preference/difference)
336346|NCT01155024|O1|Outcome|Socket Preference|Participant's indicated preference of socket type (preferred traditional socket, preferred direct manufactured socket, or no preference/difference)
336347|NCT01155024|O2|Outcome|Direct Manufactured Socket|Direct manufactured prosthetic socket fitted using typical fitting techniques in either the first intervention period or second intervention period.
336348|NCT01155024|O1|Outcome|Traditional Socket|Traditional diagnostic prosthetic socket fitted using typical fitting techniques in either the first intervention period or second intervention period.
336349|NCT01155024|E2|Reported Event|Direct Manufactured Socket|Initial fitting of a direct manufactured prosthetic socket
336350|NCT01155024|E1|Reported Event|Traditional Socket|Initial fitting of a traditional diagnostic prosthetic socket
336351|NCT01155011|B3|Baseline|Total|Total of all reporting groups
336352|NCT01155011|B2|Baseline|Health Education Control|The control group will receive an active health education intervention. The lectures will be delivered to match the MIPARC intervention schedule. Sessions will include information on general health and healthy aging. Physical activity will not be discussed in these sessions but participants will receive information on the benefits of PA. Control participants will also receive a health check phone call to match the individual attention paid to participants in the MIPARC intervention sites.
336353|NCT01155011|B1|Baseline|MIPARC Intervention|"Intervention participants engage in group education session, individual phone counseling calls and group walks for the first 6 months. The telephone counseling calls will be eliminated after 3 months.~Participants monitor their steps with a pedometer, daily step logs and progress charts. All participants will have a gradually increasing fixed step goal for each week that will result in an total increase of 3000 steps after 3 months, which they will be supported to maintain for an additional 3 months. They receive support from peer leaders. The peer leaders also receive advocacy training from a non-profit advocacy organization to conduct walk audits of their CCRC and help mobilize participants to make changes to their community that will increase or improve the opportunities for physical activity."
336354|NCT01155011|P2|Participant Flow|Health Education Control|The control group will receive an active health education intervention. The education curriculum will involve both lectures and mailed materials. The lectures will be delivered to match the MIPARC intervention schedule. Sessions will include information on general health and healthy aging. Physical activity will not be discussed in these sessions but participants will receive information on the benefits of PA. Control participants will also receive a health check phone call to match the individual attention paid to participants in the MIPARC intervention sites.
336355|NCT01155011|P1|Participant Flow|MIPARC Intervention|"The intervention will focus on increasing light to moderate PA, primarily promoting walking by gradually increasing participants' daily step counts.~Participants will monitor their steps with a pedometer, daily step logs and progress charts. All participants will have a gradually increasing fixed step goal for each week that will result in an total increase of 3000 steps after 3 months, which they will be supported to maintain for an additional 3 months. Participants will attend group educational sessions and group walks, receive phone counseling calls from UCSD counselors, receive support from peer mentors, In order to increase the sustainability of the project, MIPARC will focus on addressing on-site policies and neighborhood factors that are barriers to physical activity."
336356|NCT01155011|O2|Outcome|Health Education Control|The control group will receive an active health education intervention. The lectures will be delivered to match the MIPARC intervention schedule. Sessions will include information on general health and healthy aging. Physical activity will not be discussed in these sessions but participants will receive information on the benefits of PA. Control participants will also receive a health check phone call to match the individual attention paid to participants in the MIPARC intervention sites.
336357|NCT01155011|O1|Outcome|MIPARC Intervention|"Intervention participants engage in group education session, individual phone counseling calls and group walks for the first 6 months. The telephone counseling calls will be eliminated after 3 months.~Participants monitor their steps with a pedometer, daily step logs and progress charts. All participants will have a gradually increasing fixed step goal for each week that will result in an total increase of 3000 steps after 3 months, which they will be supported to maintain for an additional 3 months. They receive support from peer leaders."
336358|NCT01155011|O2|Outcome|Health Education Control|The control group will receive an active health education intervention.. The lectures will be delivered to match the MIPARC intervention schedule.
336359|NCT01155011|O1|Outcome|MIPARC Intervention|Participants received group educations sessions, group walks, phone counseling, support from peer leaders.
336360|NCT01155011|O2|Outcome|Health Education Control|The control group will receive an active health education intervention. The lectures will be delivered to match the MIPARC intervention schedule. Sessions will include information on general health and healthy aging. Physical activity will not be discussed in these sessions but participants will receive information on the benefits of PA.
336361|NCT01155011|O1|Outcome|MIPARC Intervention|Intervention participants received group education sessions, group walks, phone counseling and support from peer leaders.
336428|NCT01154816|E11|Reported Event|Recurrent Childhood Acute Myeloid Leukemia|Experimental: Arm 11
336431|NCT01154816|E8|Reported Event|Recurrent Childhood Germ Cell Tumor|Experimental: Arm 8
336362|NCT01155011|E2|Reported Event|Health Education Control|The control group will receive an active health education intervention. The lectures will be delivered to match the MIPARC intervention schedule. Sessions will include information on general health and healthy aging. Physical activity will not be discussed in these sessions but participants will receive information on the benefits of PA.
336363|NCT01155011|E1|Reported Event|MIPARC Intervention|Intervention participants received group education sessions, group walks, phone counseling and support from peer leaders.
336364|NCT01154985|B4|Baseline|Total|Total of all reporting groups
336365|NCT01154985|B3|Baseline|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
336366|NCT01154985|B2|Baseline|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
336367|NCT01154985|B1|Baseline|Placebo|Placebo: Placebo three times a day (TID) for 365 days
336368|NCT01154985|P3|Participant Flow|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
336369|NCT01154985|P2|Participant Flow|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
336370|NCT01154985|P1|Participant Flow|Placebo|Placebo: Placebo three times a day (TID) for 365 days
336371|NCT01154985|O3|Outcome|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
336372|NCT01154985|O2|Outcome|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
336373|NCT01154985|O1|Outcome|Placebo|Placebo: Placebo three times a day (TID) for 365 days
336374|NCT01154985|O3|Outcome|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
336375|NCT01154985|O2|Outcome|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
336376|NCT01154985|O1|Outcome|Placebo|Placebo: Placebo three times a day (TID) for 365 days
336377|NCT01154985|O3|Outcome|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
336378|NCT01154985|O2|Outcome|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
336379|NCT01154985|O1|Outcome|Placebo|Placebo: Placebo three times a day (TID) for 365 days
336380|NCT01154985|E3|Reported Event|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
336381|NCT01154985|E2|Reported Event|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
336382|NCT01154985|E1|Reported Event|Placebo|Placebo: Placebo three times a day (TID) for 365 days
336383|NCT01154816|B13|Baseline|Total|Total of all reporting groups
336384|NCT01154816|B12|Baseline|Rhaboid Malignancy|Experimental: Arm 12
336385|NCT01154816|B11|Baseline|Recurrent Childhood Acute Myeloid Leukemia|Experimental: Arm 11
336386|NCT01154816|B10|Baseline|Recurrent Childhood Acute Lympohblastic Leukemia|Experimental: Arm 10
336387|NCT01154816|B9|Baseline|Recurrent Wilms Tumor and Other Childhood Kidney Tumors|Experimental: Arm 9
336388|NCT01154816|B8|Baseline|Recurrent Childhood Germ Cell Tumor|Experimental: Arm 8
336389|NCT01154816|B7|Baseline|Childhood Hepatoblastoma|Experimental: Arm 7
336390|NCT01154816|B6|Baseline|Recurrent Childhood Soft Tissue Sarcoma|Experimental: Arm 6
336391|NCT01154816|B5|Baseline|Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor|Experimental: Arm 5
336392|NCT01154816|B4|Baseline|Recurrent Osteosarcoma|Experimental: Arm 4
336393|NCT01154816|B3|Baseline|Previously Treated Childhood Rhabdomyosarcoma|Experimental: Arm 3
336394|NCT01154816|B2|Baseline|Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll|Experimental: Arm 2
336395|NCT01154816|B1|Baseline|Recurrent Neuroblastoma With Measurable Disease at Enrollment|Experimental: Arm 1
336396|NCT01154816|P12|Participant Flow|Rhaboid Malignancy|Experimental: Arm 12
336397|NCT01154816|P11|Participant Flow|Recurrent Childhood Acute Myeloid Leukemia|Experimental: Arm 11
336398|NCT01154816|P10|Participant Flow|Recurrent Childhood Acute Lympohblastic Leukemia|Experimental: Arm 10
336399|NCT01154816|P9|Participant Flow|Recurrent Wilms Tumor and Other Childhood Kidney Tumors|Experimental: Arm 9
336400|NCT01154816|P8|Participant Flow|Recurrent Childhood Germ Cell Tumor|Experimental: Arm 8
336401|NCT01154816|P7|Participant Flow|Childhood Hepatoblastoma|Experimental: Arm 7
336402|NCT01154816|P6|Participant Flow|Recurrent Childhood Soft Tissue Sarcoma|Experimental: Arm 6
336403|NCT01154816|P5|Participant Flow|Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor|Experimental: Arm 5
336404|NCT01154816|P4|Participant Flow|Recurrent Osteosarcoma|Experimental: Arm 4
336405|NCT01154816|P3|Participant Flow|Previously Treated Childhood Rhabdomyosarcoma|Experimental: Arm 3
336406|NCT01154816|P2|Participant Flow|Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll|Experimental: Arm 2
336407|NCT01154816|P1|Participant Flow|Recurrent Neuroblastoma With Measurable Disease at Enrollment|Experimental: Arm 1
336408|NCT01154816|O1|Outcome|All Patients|All patients.
336409|NCT01154816|O1|Outcome|All Patients|All patients.
336410|NCT01154816|O1|Outcome|All Patients|All patients.
336411|NCT01154816|O1|Outcome|All Patients|All patients.
336412|NCT01154816|O1|Outcome|All Patients|All patients.
336413|NCT01154816|O1|Outcome|All Patients|All patients.
336414|NCT01154816|O1|Outcome|All Patients|All patients
336415|NCT01154816|O12|Outcome|Rhaboid Malignancy|Experimental: Arm 12
336416|NCT01154816|O11|Outcome|Recurrent Childhood Acute Myeloid Leukemia|Experimental: Arm 11
336417|NCT01154816|O10|Outcome|Recurrent Childhood Acute Lympohblastic Leukemia|Experimental: Arm 10
336418|NCT01154816|O9|Outcome|Recurrent Wilms Tumor and Other Childhood Kidney Tumors|Experimental: Arm 9
336419|NCT01154816|O8|Outcome|Recurrent Childhood Germ Cell Tumor|Experimental: Arm 8
336420|NCT01154816|O7|Outcome|Childhood Hepatoblastoma|Experimental: Arm 7
336421|NCT01154816|O6|Outcome|Recurrent Childhood Soft Tissue Sarcoma|Experimental: Arm 6
336422|NCT01154816|O5|Outcome|Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor|Experimental: Arm 5
336423|NCT01154816|O4|Outcome|Recurrent Osteosarcoma|Experimental: Arm 4
336424|NCT01154816|O3|Outcome|Previously Treated Childhood Rhabdomyosarcoma|Experimental: Arm 3
336425|NCT01154816|O2|Outcome|Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll|Experimental: Arm 2
336426|NCT01154816|O1|Outcome|Recurrent Neuroblastoma With Measurable Disease at Enrollment|Experimental: Arm 1
336427|NCT01154816|E12|Reported Event|Rhaboid Malignancy|Experimental: 12
336434|NCT01154816|E5|Reported Event|Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor|Experimental: Arm 5
336435|NCT01154816|E4|Reported Event|Recurrent Osteosarcoma|Experimental: Arm 4
336436|NCT01154816|E3|Reported Event|Previously Treated Childhood Rhabdomyosarcoma|Experimental: Arm 3
336437|NCT01154816|E2|Reported Event|Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll|Experimental: Arm 2
336438|NCT01154816|E1|Reported Event|Recurrent Neuroblastoma With Measurable Disease at Enrollment|Experimental: Arm 1
336439|NCT01154751|B1|Baseline|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
336440|NCT01154751|P1|Participant Flow|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
336441|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
336442|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
336443|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
336444|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
336445|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
336446|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
336447|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
336448|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
336449|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
336450|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
336451|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
336452|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
336453|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
336454|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
336455|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
336456|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
336457|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
336458|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
336459|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
336460|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
336461|NCT01154751|E1|Reported Event|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System~SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
336462|NCT01154699|B3|Baseline|Total|Total of all reporting groups
336463|NCT01154699|B2|Baseline|Asthma + OSA|Subjects meeting all inclusion criteria and no exclusion criteria with asthma and obstructive sleep apnea on continuous positive airway pressure (CPAP) treatment
336464|NCT01154699|B1|Baseline|Asthma Only|Subjects meeting all inclusion criteria and no exclusion criteria with asthma only (no sleep apnea)
336465|NCT01154699|P2|Participant Flow|Bilevel PAP First, Then Usual Care|"Subjects will begin the study by starting on Bilevel PAP for 4 weeks. Just before and after the Bilevel PAP they will complete questionnaires and breathing tests. After a 4 week Washout Period of usual care, they will start a Usual Care period for 4 weeks. They will complete questionnaires and breathing tests at the start and end of this 4 week period."
336466|NCT01154699|P1|Participant Flow|Usual Care First, Then Bilevel PAP|"Subjects will begin the study by continuing their usual care for 4 weeks. They will complete questionnaires and breathing tests at the start and end of this 4 week period. After a Washout Period of an additional 4 weeks of usual care, they will then start Bilevel PAP therapy for 4 weeks. Just before and after the Bilevel PAP they will complete questionnaires and breathing tests."
336467|NCT01154699|O2|Outcome|Bi-level PAP|"Subjects wear Bi-level PAP during the night for 4 weeks, and record asthma quality of life and asthma symptoms.~Bi-level positive airway pressure (bi-level PAP): Subjects will use bi-level PAP each night for 4 weeks. The pressure levels will be adjusted by the investigators to increase lung volumes during the night."
336468|NCT01154699|O1|Outcome|Usual Care|Subjects record asthma quality of life and symptoms, without intervention for 4 weeks.
336469|NCT01154699|O2|Outcome|Bi-level PAP|"Subjects wear Bi-level PAP during the night for 4 weeks, and record asthma quality of life and asthma symptoms.~Bi-level positive airway pressure (bi-level PAP): Subjects will use bi-level PAP each night for 4 weeks. The pressure levels will be adjusted by the investigators to increase lung volumes during the night."
336470|NCT01154699|O1|Outcome|Usual Care|Subjects record asthma quality of life and symptoms, without intervention for 4 weeks.
336471|NCT01154699|O2|Outcome|Bi-level PAP|"Subjects wear Bi-level PAP during the night for 4 weeks, and record asthma quality of life and asthma symptoms.~Bi-level positive airway pressure (bi-level PAP): Subjects will use bi-level PAP each night for 4 weeks. The pressure levels will be adjusted by the investigators to increase lung volumes during the night."
336472|NCT01154699|O1|Outcome|Usual Care|Subjects record asthma quality of life and symptoms, without intervention for 4 weeks.
336473|NCT01154699|O2|Outcome|Bi-level PAP|"Subjects wear Bi-level PAP during the night for 4 weeks, and record asthma quality of life and asthma symptoms.~Bi-level positive airway pressure (bi-level PAP): Subjects will use bi-level PAP each night for 4 weeks. The pressure levels will be adjusted by the investigators to increase lung volumes during the night."
336474|NCT01154699|O1|Outcome|Usual Care|Subjects record asthma quality of life and symptoms, without intervention for 4 weeks.
336475|NCT01154699|O2|Outcome|Bi-level PAP|"Subjects wear Bi-level PAP during the night for 4 weeks, and record asthma quality of life and asthma symptoms.~Bi-level positive airway pressure (bi-level PAP): Subjects will use bi-level PAP each night for 4 weeks. The pressure levels will be adjusted by the investigators to increase lung volumes during the night."
336476|NCT01154699|O1|Outcome|Usual Care|Subjects record asthma quality of life and symptoms, without intervention for 4 weeks.
336477|NCT01154699|O2|Outcome|Bilevel PAP|Subjects will wear Bilevel PAP for 4 weeks. Just before and after the Bilevel PAP they will complete questionnaires and breathing tests.
336478|NCT01154699|O1|Outcome|Usual Care|Subjects will begin the study by continuing their usual care for 4 weeks. They will complete questionnaires and breathing tests at the start and end of this 4 week period.
336479|NCT01154699|E2|Reported Event|Asthma + OSA|Subjects meeting all inclusion criteria and no exclusion criteria with asthma and obstructive sleep apnea on continuous positive airway pressure (CPAP) treatment
336480|NCT01154699|E1|Reported Event|Asthma Only|Subjects meeting all inclusion criteria and no exclusion criteria with asthma only (no sleep apnea)
336481|NCT01154673|B3|Baseline|Total|Total of all reporting groups
336482|NCT01154673|B2|Baseline|Placebo Arm|Placebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID)
336483|NCT01154673|B1|Baseline|Intensive HAART|"Patients in this arm will receive the following HAART regimen:~Raltegravir 400 mg BID + Maraviroc 150mg BID + emtricitabine 200mg /tenofovir 300mg QD + lopinavir 400 mg/ritonavir 100mg BID"
336484|NCT01154673|P2|Participant Flow|Placebo Arm|Placebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID) and endpoint is measured at 48 weeks
336485|NCT01154673|P1|Participant Flow|Intensive HAART|"Patients in this arm will receive the following HAART regimen:~Raltegravir 400 mg BID + Maraviroc 150mg BID + emtricitabine 200mg /tenofovir 300mg QD + lopinavir 400 mg/ritonavir 100mg BID and endpoint is measured at 48 weeks"
336486|NCT01154673|O2|Outcome|Placebo Arm|Placebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID)
336487|NCT01154673|O1|Outcome|Intensive HAART|"Patients in this arm will receive the following HAART regimen:~Raltegravir 400 mg BID + Maraviroc 150mg BID + emtricitabine 200mg /tenofovir 300mg QD + lopinavir 400 mg/ritonavir 100mg BID"
336488|NCT01154673|E2|Reported Event|Placebo Arm|Placebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID)
336489|NCT01154673|E1|Reported Event|Intensive HAART|"Patients in this arm will receive the following HAART regimen:~Raltegravir 400 mg BID + Maraviroc 150mg BID + emtricitabine 200mg /tenofovir 300mg QD + lopinavir 400 mg/ritonavir 100mg BID"
336490|NCT01154634|B5|Baseline|Total|Total of all reporting groups
336491|NCT01154634|B4|Baseline|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
336492|NCT01154634|B3|Baseline|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
336493|NCT01154634|B2|Baseline|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
336494|NCT01154634|B1|Baseline|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
336495|NCT01154634|P4|Participant Flow|First Placebo, Then 40 mg, Then 5 mg, Then 16 mg|period 1: placebo, period 2: washout, period 3: AZD2516 40 mg, period 4: washout, period 5: AZD2516 5 mg, period 6: washout, period 7: AZD2516 16 mg
336496|NCT01154634|P3|Participant Flow|First 16 mg, Then 5 mg, Then 40 mg, Then Placebo|period 1: AZD2516 16 mg, period 2: washout, period 3: AZD2516 5 mg, period 4: washout, period 5: AZD2516 40 mg, period 6: washout, period 7: placebo.
336497|NCT01154634|P2|Participant Flow|First 40 mg, Then 16 mg, Then Placebo, Then 5 mg|period 1: AZD2516 40 mg, period 2: washout, period 3: AZD2516 16 mg, period 4: washout, period 5: placebo, period 6: washout, period 7: AZD2516 5 mg.
336498|NCT01154634|P1|Participant Flow|First 5 mg, Then Placebo, Then 16 mg, Then 40 mg|period 1: AZD2516 5 mg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD2516 16 mg, period 6: washout, period 7: AZD2516 40 mg.
336499|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
336500|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
336501|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
336502|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
336503|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
337415|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
336504|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
336505|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
336506|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
336507|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
336508|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
336509|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
336510|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
336511|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
336512|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
336513|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
336514|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
336515|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
336516|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
336517|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
336518|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
336519|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
336520|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
336521|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
336522|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
336523|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
336524|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
336525|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
336526|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
336527|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
336528|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
336529|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
336530|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
336531|NCT01154634|E4|Reported Event|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
336532|NCT01154634|E3|Reported Event|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
336533|NCT01154634|E2|Reported Event|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
336534|NCT01154634|E1|Reported Event|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
336535|NCT01154452|B5|Baseline|Total|Total of all reporting groups
336536|NCT01154452|B4|Baseline|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
336537|NCT01154452|B3|Baseline|ARM 1 - RO4929097: 15 mg PO QD|ARM 1 - RO4929097: 15 mg PO QD
336538|NCT01154452|B2|Baseline|RO4929097 15 mg|RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD
336539|NCT01154452|B1|Baseline|RO4929097 10mg|RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD
336540|NCT01154452|P4|Participant Flow|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
336541|NCT01154452|P3|Participant Flow|ARM 1 - RO4929097: 15 mg PO QD|ARM 1 - RO4929097: 15 mg PO QD
336542|NCT01154452|P2|Participant Flow|RO4929097 15 mg|RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD
336543|NCT01154452|P1|Participant Flow|RO4929097 10mg|RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD
351295|NCT01119222|O1|Outcome|Gabpentin|Gabapentin 1200 mg
336544|NCT01154452|O4|Outcome|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
336545|NCT01154452|O3|Outcome|ARM 1 - RO4929097: 15 mg PO QD|ARM 1 - RO4929097: 15 mg PO QD
336546|NCT01154452|O2|Outcome|RO4929097 15 mg|RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD
336547|NCT01154452|O1|Outcome|RO4929097 10mg|RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD
336548|NCT01154452|O1|Outcome|All Phase Ib Participants|All Phase Ib Participants
336549|NCT01154452|E4|Reported Event|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
336550|NCT01154452|E3|Reported Event|ARM 1 - RO4929097: 15 mg PO QD|ARM 1 - RO4929097: 15 mg PO QD
336551|NCT01154452|E2|Reported Event|RO4929097 15 mg|RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD
336552|NCT01154452|E1|Reported Event|RO4929097 10mg|RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD
336553|NCT01154335|B4|Baseline|Total|Total of all reporting groups
336554|NCT01154335|B3|Baseline|Dose Level 2a|"combination of OSI-906 and everolimus~OSI-906: 100 mg Twice a Day, cycle-28 days~Everolimus: 5mg Daily, cycle-28 days"
336555|NCT01154335|B2|Baseline|Dose Level 2|"combination of OSI-906 and everolimus~OSI-906: 100 mg Twice a Day, cycle-28 days~Everolimus: 10mg Daily, cycle-28 days"
336556|NCT01154335|B1|Baseline|Dose Level 1|"combination of OSI-906 and everolimus~OSI-906: 50 mg Twice a Day, cycle-28 days~Everolimus: 5mg Daily, cycle-28 days"
336557|NCT01154335|P3|Participant Flow|Dose Level 2a|"combination of OSI-906 and everolimus~OSI-906: 100 mg Twice a Day, cycle-28 days~Everolimus: 5mg Daily, cycle-28 days"
336558|NCT01154335|P2|Participant Flow|Dose Level 2|"combination of OSI-906 and everolimus~OSI-906: 100 mg Twice a Day, cycle-28 days~Everolimus: 10mg Daily, cycle-28 days"
336559|NCT01154335|P1|Participant Flow|Dose Level 1|"combination of OSI-906 and everolimus~OSI-906: 50 mg Twice a Day, cycle-28 days~Everolimus: 5mg Daily, cycle-28 days"
336560|NCT01154335|O1|Outcome|All Patients|Response Rate was determined only as a preliminary indication of efficacy and was calculated for all patients at all dose levels
336561|NCT01154335|O1|Outcome|All Patients|Overall Survival was determined only as a preliminary indication of efficacy and was calculated for all patients at all dose levels
336562|NCT01154335|O1|Outcome|All Patients|Progression-Free Survival was determined only as a preliminary indication of efficacy and was calculated for all patients at all dose levels
336563|NCT01154335|O1|Outcome|All Patients|Determination of the MTD consists of the selection of one of the three dose levels as the maximum tolerated dose. This outcome is the same for all patients.
336564|NCT01154335|E1|Reported Event|All Patients|Adverse Event data was was calculated for all patients at all dose levels
336565|NCT01154322|B1|Baseline|Pediatric Mask|Pixi pediatric mask : The study mask is designed for use with PAP therapy to treat OSA in pediatric patients aged 2-7 years. The study mask is designed to be used in the hospital and the home environment. The study subject will use the device for up to 30 days while participating in the study.
336566|NCT01154322|P1|Participant Flow|Pediatric Mask|Pixi pediatric mask : The study mask is designed for use with PAP therapy to treat OSA in pediatric patients aged 2-7 years. The study mask is designed to be used in the hospital and the home environment. The study subject will use the device for up to 30 days while participating in the study.
336567|NCT01154322|O1|Outcome|Pixi Mask|AHI with Pixi mask
336568|NCT01154322|O1|Outcome|Currently-used Mask|Baseline AHI prior to Pixi mask use
336569|NCT01154322|E1|Reported Event|Overall Study|
336570|NCT01154296|B3|Baseline|Total|Total of all reporting groups
336571|NCT01154296|B2|Baseline|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
336572|NCT01154296|B1|Baseline|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
336573|NCT01154296|P2|Participant Flow|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
336574|NCT01154296|P1|Participant Flow|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
336575|NCT01154296|O2|Outcome|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
336642|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
336643|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
337416|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
336576|NCT01154296|O1|Outcome|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
336577|NCT01154296|O2|Outcome|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
336578|NCT01154296|O1|Outcome|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
336579|NCT01154296|O2|Outcome|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
336580|NCT01154296|O1|Outcome|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
336581|NCT01154296|O2|Outcome|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
336582|NCT01154296|O1|Outcome|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
336583|NCT01154296|O2|Outcome|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
336584|NCT01154296|O1|Outcome|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
336585|NCT01154296|O2|Outcome|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
336586|NCT01154296|O1|Outcome|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
336587|NCT01154296|E2|Reported Event|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
336644|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
336588|NCT01154296|E1|Reported Event|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
336589|NCT01154283|B3|Baseline|Total|Total of all reporting groups
336590|NCT01154283|B2|Baseline|IPAP-only, NIPPV Then Bi-level, Standard NIPPV|"NIPPV with only inspiratory positive airway pressure (IPAP-only), no expiratory positive airway pressure then Standard NIPPV with both an inspiratory and expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
336591|NCT01154283|B1|Baseline|Bi-level, Standard, NIPPV Then IPAP-only NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure then NIPPV with only inspiratory positive airway pressure (IPAP-only), no expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
336592|NCT01154283|P2|Participant Flow|IPAP-only, NIPPV Then Bi-level, Standard NIPPV|"NIPPV with only inspiratory positive airway pressure (IPAP-only), no expiratory positive airway pressure then Standard NIPPV with both an inspiratory and expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
336593|NCT01154283|P1|Participant Flow|Bi-level, Standard, NIPPV Then IPAP-only NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure then NIPPV with only inspiratory positive airway pressure (IPAP-only), no expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
336594|NCT01154283|O2|Outcome|IPAP-only, NIPPV|"NIPPV with only inspiratory positive airway pressure, no expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
336595|NCT01154283|O1|Outcome|Bi-level, Standard, NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure.~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
336596|NCT01154283|O2|Outcome|IPAP-only, NIPPV|"NIPPV with only inspiratory positive airway pressure, no expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
336597|NCT01154283|O1|Outcome|Bi-level, Standard, NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure.~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
336598|NCT01154283|O2|Outcome|IPAP-only, NIPPV|"NIPPV with only inspiratory positive airway pressure, no expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
336599|NCT01154283|O1|Outcome|Bi-level, Standard, NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure.~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
336600|NCT01154283|O2|Outcome|IPAP-only, NIPPV|"NIPPV with only inspiratory positive airway pressure, no expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
336601|NCT01154283|O1|Outcome|Bi-level, Standard, NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure.~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
336602|NCT01154283|E2|Reported Event|IPAP-only, NIPPV|"NIPPV with only inspiratory positive airway pressure (IPAP-only), no expiratory positive airway pressure.~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
336603|NCT01154283|E1|Reported Event|Bi-level, Standard, NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure.~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
336604|NCT01154231|B1|Baseline|BeneFIX (Nonacog Alfa)|Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician’s discretion.
336605|NCT01154231|P1|Participant Flow|BeneFIX (Nonacog Alfa)|Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician’s discretion.
336606|NCT01154231|O1|Outcome|BeneFIX (Nonacog Alfa)|Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician’s discretion.
336607|NCT01154231|O1|Outcome|BeneFIX (Nonacog Alfa)|Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician’s discretion.
336608|NCT01154231|O1|Outcome|BeneFIX (Nonacog Alfa)|Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician’s discretion.
336609|NCT01154231|E1|Reported Event|BeneFIX (Nonacog Alfa)|Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician’s discretion.
336610|NCT01154218|B1|Baseline|Entire Study Population|Includes participants randomized to receive any treatment (crizotinib 250 mg IRT fasted first, crizotinib 250 mg PIC fasted first, crizotinib 250 mg CIC fasted first and crizotinib 250 mg CIC fed).
336645|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
336611|NCT01154218|P4|Participant Flow|Crizotinib 250 mg CIC Fed, CIC Fasted, PIC Fasted, IRT Fasted|Single oral dose of crizotinib 250 mg CIC in fed state in first intervention period; followed by single oral dose of crizotinib 250 mg CIC in fasted state in second intervention period; followed by single oral dose of crizotinib 250 mg PIC in fasted state in third intervention period; and single oral dose of crizotinib 250 mg IRT in fasted state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
336612|NCT01154218|P3|Participant Flow|Crizotinib 250 mg CIC Fasted, IRT Fasted, CIC Fed, PIC Fasted|Single oral dose of crizotinib 250 mg CIC in fasted state in first intervention period; followed by single oral dose of crizotinib 250 mg IRT in fasted state in second intervention period; followed by single oral dose of crizotinib 250 mg CIC in fed state in third intervention period; and single oral dose of crizotinib 250 mg PIC in fasted state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
336613|NCT01154218|P2|Participant Flow|Crizotinib 250 mg PIC Fasted, CIC Fed, IRT Fasted, CIC Fasted|Single oral dose of crizotinib 250 mg PIC in fasted state in first intervention period; followed by single oral dose of crizotinib 250 mg CIC in fed state in second intervention period; followed by single oral dose of crizotinib 250 mg IRT in fasted state in third intervention period; and single oral dose of crizotinib 250 mg CIC in fasted state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
336614|NCT01154218|P1|Participant Flow|Crizotinib 250 mg IRT Fasted, PIC Fasted, CIC Fasted, CIC Fed|Single oral dose of crizotinib 250 milligram (mg) immediate release tablet (IRT) in fasted state in first intervention period; followed by single oral dose of crizotinib 250 mg powder in capsule (PIC) in fasted state in second intervention period; followed by single oral dose of crizotinib 250 mg commercial image capsule (CIC) in fasted state in third intervention period; and single oral dose of crizotinib 250 mg CIC in fed state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
336615|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
336616|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
336617|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
336618|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
336619|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
336620|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
336621|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
336622|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
336623|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
336624|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
336625|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
336626|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
336627|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
336628|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
336629|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
336630|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
336631|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
336632|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
336633|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
336634|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
336635|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
336636|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
336637|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
336638|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
336639|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
336640|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
336641|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
337417|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
336646|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
336647|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
336648|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
336649|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
336650|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
336651|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
336652|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
336653|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
336654|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
336655|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
336656|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
336657|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
336658|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
336659|NCT01154218|E4|Reported Event|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
336660|NCT01154218|E3|Reported Event|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
336661|NCT01154218|E2|Reported Event|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
336662|NCT01154218|E1|Reported Event|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
336663|NCT01154166|B3|Baseline|Total|Total of all reporting groups
336664|NCT01154166|B2|Baseline|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
336665|NCT01154166|B1|Baseline|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
336666|NCT01154166|P2|Participant Flow|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
336667|NCT01154166|P1|Participant Flow|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
336668|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
336705|NCT01154153|O2|Outcome|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
336797|NCT01154101|B3|Baseline|SRT2104 0.5 g|Eligible participants received SRT2104 0.5 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336669|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
336670|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
336671|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
336672|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
336673|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
336674|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
336675|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
336676|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
336677|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
336678|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
336706|NCT01154153|O1|Outcome|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
336679|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
336680|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
336681|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
336682|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
336683|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
336684|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
336685|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
336686|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
336687|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
336688|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
336707|NCT01154153|O2|Outcome|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
336689|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
336690|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
336691|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
336692|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
336693|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
336694|NCT01154166|E2|Reported Event|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
336695|NCT01154166|E1|Reported Event|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
336696|NCT01154153|B3|Baseline|Total|Total of all reporting groups
336697|NCT01154153|B2|Baseline|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
336698|NCT01154153|B1|Baseline|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
336699|NCT01154153|P2|Participant Flow|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
336700|NCT01154153|P1|Participant Flow|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
336701|NCT01154153|O2|Outcome|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
336702|NCT01154153|O1|Outcome|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
336703|NCT01154153|O2|Outcome|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
336704|NCT01154153|O1|Outcome|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
336708|NCT01154153|O1|Outcome|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
336709|NCT01154153|O2|Outcome|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
336710|NCT01154153|O1|Outcome|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
336711|NCT01154153|O2|Outcome|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
336712|NCT01154153|O1|Outcome|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
336713|NCT01154153|E2|Reported Event|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
336714|NCT01154153|E1|Reported Event|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
336715|NCT01154140|B3|Baseline|Total|Total of all reporting groups
336716|NCT01154140|B2|Baseline|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
336717|NCT01154140|B1|Baseline|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336718|NCT01154140|P2|Participant Flow|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 intravenous (IV) infusion according to standard of care was administered over 10 minutes (min); either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an area under the concentration time curve (AUC) of 5 or 6 milligram*minute per millilitre (mg*min/mL), approximately 30 min after end of pemetrexed infusion.
336719|NCT01154140|P1|Participant Flow|Crizotinib|Crizotinib 250 mg (milligram) capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of (Response Evaluation Criteria in Solid Tumors) RECIST v1.1 defined PD, as determined by Independent Radiology Review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336720|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
336721|NCT01154140|O1|Outcome|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336722|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
336723|NCT01154140|O1|Outcome|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336724|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
336725|NCT01154140|O1|Outcome|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336726|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
336727|NCT01154140|O1|Outcome|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336728|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
336729|NCT01154140|O1|Outcome|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336730|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
336731|NCT01154140|O1|Outcome|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336732|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
336733|NCT01154140|O1|Outcome|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336734|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
336735|NCT01154140|O1|Outcome|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336736|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
336737|NCT01154140|O1|Outcome|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336738|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
336739|NCT01154140|O1|Outcome|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336740|NCT01154140|O1|Outcome|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336741|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
336742|NCT01154140|O1|Outcome|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336795|NCT01154101|B5|Baseline|No Treatment|Eligible participants in this arm received no treatment. No treatment arm was used when participants were randomized but discontinued prior to dosing.
336976|NCT01154036|O3|Outcome|Phase I: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
336743|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
336744|NCT01154140|O1|Outcome|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336745|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
336746|NCT01154140|O1|Outcome|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336747|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
336748|NCT01154140|O1|Outcome|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336749|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
336750|NCT01154140|O1|Outcome|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336751|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
336752|NCT01154140|O1|Outcome|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336753|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
336754|NCT01154140|O1|Outcome|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336755|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
336756|NCT01154140|O1|Outcome|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336757|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
336758|NCT01154140|O1|Outcome|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336977|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
336759|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
336760|NCT01154140|O1|Outcome|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336761|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
336762|NCT01154140|O1|Outcome|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336763|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
336764|NCT01154140|O1|Outcome|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336765|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
336766|NCT01154140|O1|Outcome|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336767|NCT01154140|E2|Reported Event|Chemotherapy|Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
336768|NCT01154140|E1|Reported Event|Crizotinib|Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
336769|NCT01154127|B3|Baseline|Total|Total of all reporting groups
336770|NCT01154127|B2|Baseline|Placebo Followed by NVA237|"Period 1: Matching placebo of NVA237 via NEOHALER inhaler device for 21 days~Period 2: 50 μg NVA237 via NEOHALER inhaler device for 21 days.~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
336771|NCT01154127|B1|Baseline|NVA237 Followed by Placebo|"Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days.~Period 2: Matching placebo via NEOHALER inhaler device for 21 days~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
336772|NCT01154127|P2|Participant Flow|Placebo Followed by NVA237|"Period 1: Matching placebo of NVA237 via NEOHALER inhaler device for 21 days~Period 2: 50 μg NVA237 via NEOHALER inhaler device for 21 days.~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
336773|NCT01154127|P1|Participant Flow|NVA237 Followed by Placebo|"Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days.~Period 2: Matching placebo via NEOHALER inhaler device for 21 days~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
336774|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
336775|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
336796|NCT01154101|B4|Baseline|SRT2104 1.0 g|Eligible participants received SRT2104 1.0 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336776|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
336777|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
336778|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
336779|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
336780|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
336781|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
336782|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
336783|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
336784|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
336785|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
336786|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
336787|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
336788|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
336789|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
336790|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
336791|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
336792|NCT01154127|E2|Reported Event|Placebo|"Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days~Period 2: Matching placebo via NEOHALER inhaler device for 21 days~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
336793|NCT01154127|E1|Reported Event|NVA237|"Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days~Period 2: Matching placebo via NEOHALER inhaler device for 21 days~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
336794|NCT01154101|B6|Baseline|Total|Total of all reporting groups
337418|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
336798|NCT01154101|B2|Baseline|SRT2104 0.25 g|Eligible participants received SRT2104 0.25 gram (g) capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336799|NCT01154101|B1|Baseline|Placebo|Eligible participants received SRT2104 matching placebo capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336800|NCT01154101|P5|Participant Flow|No Treatment|Eligible participants in this arm received no treatment. No treatment arm was used when participants were randomized but discontinued prior to dosing.
336801|NCT01154101|P4|Participant Flow|SRT2104 1.0 g|Eligible participants received SRT2104 1.0 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336802|NCT01154101|P3|Participant Flow|SRT2104 0.5 g|Eligible participants received SRT2104 0.5 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336803|NCT01154101|P2|Participant Flow|SRT2104 0.25 g|Eligible participants received SRT2104 0.25 gram (g) capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336804|NCT01154101|P1|Participant Flow|Placebo|Eligible participants received SRT2104 matching placebo capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336805|NCT01154101|O4|Outcome|SRT2104 1.0 g|Eligible participants received SRT2104 1.0 g capsules, orally, once daily after meal (at the same time every dosing day) for 84 days.
336806|NCT01154101|O3|Outcome|SRT2104 0.5 g|Eligible participants received SRT2104 0.5 g capsules, orally, once daily after meal (at the same time every dosing day) for 84 days.
336807|NCT01154101|O2|Outcome|SRT2104 0.25 g|Eligible participants received SRT2104 0.25 g capsules, orally, once daily after meal (at the same time every dosing day) for 84 days.
336808|NCT01154101|O1|Outcome|Placebo|Eligible participants received SRT2104 matching placebo capsules, orally, once daily after meal (at the same time every dosing day) for 84 days.
336809|NCT01154101|O4|Outcome|SRT2104 1.0 g|Eligible participants received SRT2104 1.0 g capsules, orally, once daily after meal (at the same time every dosing day) for 84 days.
336810|NCT01154101|O3|Outcome|SRT2104 0.5 g|Eligible participants received SRT2104 0.5 g capsules, orally, once daily after meal (at the same time every dosing day) for 84 days.
336811|NCT01154101|O2|Outcome|SRT2104 0.25 g|Eligible participants received SRT2104 0.25 g capsules, orally, once daily after meal (at the same time every dosing day) for 84 days.
336812|NCT01154101|O1|Outcome|Placebo|Eligible participants received SRT2104 matching placebo capsules, orally, once daily after meal (at the same time every dosing day) for 84 days.
336813|NCT01154101|O3|Outcome|SRT2104 1.0 g|Eligible participants received SRT2104 1.0 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336814|NCT01154101|O2|Outcome|SRT2104 0.5 g|Eligible participants received SRT2104 0.5 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336815|NCT01154101|O1|Outcome|SRT2104 0.25 g|Eligible participants received SRT2104 0.25 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336816|NCT01154101|O3|Outcome|SRT2104 1.0 g|Eligible participants received SRT2104 1.0 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336817|NCT01154101|O2|Outcome|SRT2104 0.5 g|Eligible participants received SRT2104 0.5 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336818|NCT01154101|O1|Outcome|SRT2104 0.25 g|Eligible participants received SRT2104 0.25 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336819|NCT01154101|O4|Outcome|SRT2104 1.0 g|Eligible participants received SRT2104 1.0 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336820|NCT01154101|O3|Outcome|SRT2104 0.5 g|Eligible participants received SRT2104 0.5 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336821|NCT01154101|O2|Outcome|SRT2104 0.25 g|Eligible participants received SRT2104 0.25 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336822|NCT01154101|O1|Outcome|Placebo|Eligible participants received SRT2104 matching placebo capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336823|NCT01154101|O4|Outcome|SRT2104 1.0 g|Eligible participants received SRT2104 1.0 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336824|NCT01154101|O3|Outcome|SRT2104 0.5 g|Eligible participants received SRT2104 0.5 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336825|NCT01154101|O2|Outcome|SRT2104 0.25 g|Eligible participants received SRT2104 0.25 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336826|NCT01154101|O1|Outcome|Placebo|Eligible participants received SRT2104 matching placebo capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336827|NCT01154101|O4|Outcome|SRT2104 1.0 g|Eligible participants received SRT2104 1.0 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336828|NCT01154101|O3|Outcome|SRT2104 0.5 g|Eligible participants received SRT2104 0.5 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336829|NCT01154101|O2|Outcome|SRT2104 0.25 g|Eligible participants received SRT2104 0.25 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336830|NCT01154101|O1|Outcome|Placebo|Eligible participants received SRT2104 matching placebo capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336831|NCT01154101|O4|Outcome|SRT2104 1.0 g|Eligible participants received SRT2104 1.0 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336832|NCT01154101|O3|Outcome|SRT2104 0.5 g|Eligible participants received SRT2104 0.5 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336833|NCT01154101|O2|Outcome|SRT2104 0.25 g|Eligible participants received SRT2104 0.25 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336834|NCT01154101|O1|Outcome|Placebo|Eligible participants received SRT2104 matching placebo capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
337311|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
336835|NCT01154101|O4|Outcome|SRT2104 1.0 g|Eligible participants received SRT2104 1.0 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336836|NCT01154101|O3|Outcome|SRT2104 0.5 g|Eligible participants received SRT2104 0.5 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336837|NCT01154101|O2|Outcome|SRT2104 0.25 g|Eligible participants received SRT2104 0.25 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336838|NCT01154101|O1|Outcome|Placebo|Eligible participants received SRT2104 matching placebo capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336839|NCT01154101|O4|Outcome|SRT2104 1.0 g|Eligible participants received SRT2104 1.0 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336840|NCT01154101|O3|Outcome|SRT2104 0.5 g|Eligible participants received SRT2104 0.5 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336841|NCT01154101|O2|Outcome|SRT2104 0.25 g|Eligible participants received SRT2104 0.25 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336842|NCT01154101|O1|Outcome|Placebo|Eligible participants received SRT2104 matching placebo capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336843|NCT01154101|O4|Outcome|SRT2104 1.0 g|Eligible participants received SRT2104 1.0 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336844|NCT01154101|O3|Outcome|SRT2104 0.5 g|Eligible participants received SRT2104 0.5 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336845|NCT01154101|O2|Outcome|SRT2104 0.25 g|Eligible participants received SRT2104 0.25 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336846|NCT01154101|O1|Outcome|Placebo|Eligible participants received SRT2104 matching placebo capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336847|NCT01154101|O4|Outcome|SRT2104 1.0 g|Eligible participants received SRT2104 1.0 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336848|NCT01154101|O3|Outcome|SRT2104 0.5 g|Eligible participants received SRT2104 0.5 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336849|NCT01154101|O2|Outcome|SRT2104 0.25 g|Eligible participants received SRT2104 0.25 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336850|NCT01154101|O1|Outcome|Placebo|Eligible participants received SRT2104 matching placebo capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336851|NCT01154101|E4|Reported Event|SRT2104 1.0 g|Eligible participants received SRT2104 1.0 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336852|NCT01154101|E3|Reported Event|SRT2104 0.5 g|Eligible participants received SRT2104 0.5 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336853|NCT01154101|E2|Reported Event|SRT2104 0.25 g|Eligible participants received SRT2104 0.25 g capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336854|NCT01154101|E1|Reported Event|Placebo|Eligible participants received SRT2104 matching placebo capsules, orally, once daily after meal (at the same time every dosing day) for 12 weeks.
336855|NCT01154036|B4|Baseline|Total|Total of all reporting groups
336856|NCT01154036|B3|Baseline|Phase I: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks
336857|NCT01154036|B2|Baseline|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
336858|NCT01154036|B1|Baseline|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
336859|NCT01154036|P8|Participant Flow|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
336860|NCT01154036|P7|Participant Flow|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336861|NCT01154036|P6|Participant Flow|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
336862|NCT01154036|P5|Participant Flow|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336863|NCT01154036|P4|Participant Flow|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
336864|NCT01154036|P3|Participant Flow|Phase I: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
336865|NCT01154036|P2|Participant Flow|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
336866|NCT01154036|P1|Participant Flow|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
336867|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
336868|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
336869|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336870|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
336978|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
336871|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336872|NCT01154036|O3|Outcome|Phase I: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
336873|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
336874|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
336875|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
336876|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
336877|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336878|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
336879|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336880|NCT01154036|O3|Outcome|Phase 1: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
336881|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
336882|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
336883|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
336884|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
336885|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336886|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
336887|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336888|NCT01154036|O3|Outcome|Phase 1: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
336889|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
336890|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
336891|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
336892|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
336893|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336894|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
336895|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336896|NCT01154036|O3|Outcome|Phase 1: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
336897|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
336898|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
336899|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
336900|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
336901|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336902|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
336903|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336904|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
336905|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
336906|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
336907|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
336908|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
336909|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336910|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
336911|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336912|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
336913|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
336914|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
336915|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
336916|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
336917|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336918|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
336919|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336920|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
336921|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
336922|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
336923|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
336924|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
336925|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336926|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
336927|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336928|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
336929|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
336930|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
336931|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
336932|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
336933|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336934|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
336935|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336936|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
336937|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
336938|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
336939|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
336940|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
337006|NCT01153984|E1|Reported Event|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
336941|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336942|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
336943|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336944|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
336945|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
336946|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
336947|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
336948|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
336949|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336950|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
336951|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336952|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
336953|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
336954|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
336955|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
336956|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
336957|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336958|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
336959|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336960|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
336961|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
336962|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
336963|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
336964|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
336965|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336966|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
336967|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336968|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
336969|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
336970|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
336971|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
336972|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
336973|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336974|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
336975|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336979|NCT01154036|E8|Reported Event|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
336980|NCT01154036|E7|Reported Event|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336981|NCT01154036|E6|Reported Event|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
336982|NCT01154036|E5|Reported Event|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
336983|NCT01154036|E4|Reported Event|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
336984|NCT01154036|E3|Reported Event|Phase I: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks
336985|NCT01154036|E2|Reported Event|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
336986|NCT01154036|E1|Reported Event|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
336987|NCT01154010|B3|Baseline|Total|Total of all reporting groups
336988|NCT01154010|B2|Baseline|Placebo Device|"Patients wear the PEMF placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.~PEMF Placebo: Patients wear the placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids."
336989|NCT01154010|B1|Baseline|Active Device|"ActiPatch, a device that emits a low frequency energy called pulsed electromagnetic field (PEMF), will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.~PEMF: ActiPatch will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids."
336990|NCT01154010|P2|Participant Flow|Placebo Device|"Patients wear the PEMF placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.~PEMF Placebo: Patients wear the placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.~Analysis in process as of December, 2016."
336991|NCT01154010|P1|Participant Flow|Active Device|"ActiPatch, a device that emits a low frequency energy called pulsed electromagnetic field (PEMF), will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.~PEMF: ActiPatch will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.~Analysis in process as of December, 2016."
336992|NCT01154010|O2|Outcome|Placebo Device|"Patients wear the PEMF placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.~PEMF Placebo: Patients wear the placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.~Analysis in process as of December, 2016."
336993|NCT01154010|O1|Outcome|Active Device|"ActiPatch, a device that emits a low frequency energy called pulsed electromagnetic field (PEMF), will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.~PEMF: ActiPatch will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.~Analysis in process as of December, 2016."
336994|NCT01154010|E2|Reported Event|Placebo Device|"Patients wear the PEMF placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.~PEMF Placebo: Patients wear the placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.~Analysis on-going as of December, 2016."
336995|NCT01154010|E1|Reported Event|Active Device|"ActiPatch, a device that emits a low frequency energy called pulsed electromagnetic field (PEMF), will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.~PEMF: ActiPatch will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.~Analysis on-going as of December, 2016."
336996|NCT01153984|B1|Baseline|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
336997|NCT01153984|P1|Participant Flow|Erlotinib|Participants received 150 milligrams (mg) erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
336998|NCT01153984|O1|Outcome|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
336999|NCT01153984|O1|Outcome|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
337000|NCT01153984|O1|Outcome|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
337001|NCT01153984|O1|Outcome|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
337002|NCT01153984|O1|Outcome|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
337003|NCT01153984|O1|Outcome|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
337004|NCT01153984|O1|Outcome|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
337005|NCT01153984|O1|Outcome|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
337402|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337007|NCT01153971|B1|Baseline|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
337008|NCT01153971|P1|Participant Flow|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 milligrams per square meter (mg/m^2) intravenously (IV) and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with complete response (CR), unconfirmed complete response (CRu), or partial response (PR), received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
337009|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
337010|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
337011|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
337012|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
337013|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
337014|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
337078|NCT01153841|P1|Participant Flow|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
352863|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
337015|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
337016|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
337017|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
337018|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
337019|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
337020|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
337021|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
337022|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
337079|NCT01153841|O2|Outcome|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
337081|NCT01153841|O2|Outcome|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
337023|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
337024|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
337025|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
337026|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
337027|NCT01153971|E1|Reported Event|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
337028|NCT01153958|B3|Baseline|Total|Total of all reporting groups
337029|NCT01153958|B2|Baseline|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
337030|NCT01153958|B1|Baseline|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
337031|NCT01153958|P2|Participant Flow|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
337032|NCT01153958|P1|Participant Flow|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
337033|NCT01153958|O2|Outcome|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
337034|NCT01153958|O1|Outcome|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
337035|NCT01153958|O2|Outcome|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
337036|NCT01153958|O1|Outcome|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
337037|NCT01153958|O2|Outcome|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
337038|NCT01153958|O1|Outcome|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
337039|NCT01153958|O2|Outcome|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
337040|NCT01153958|O1|Outcome|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
337041|NCT01153958|O2|Outcome|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
337042|NCT01153958|O1|Outcome|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
337043|NCT01153958|O2|Outcome|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
337044|NCT01153958|O1|Outcome|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
337045|NCT01153958|E2|Reported Event|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
337046|NCT01153958|E1|Reported Event|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
337047|NCT01153893|B3|Baseline|Total|Total of all reporting groups
337080|NCT01153841|O1|Outcome|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
337261|NCT01153503|B2|Baseline|TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery+ IV-PCA morphine~First 24-h postoperative: IV-PCA morphine"
337048|NCT01153893|B2|Baseline|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
337049|NCT01153893|B1|Baseline|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
337050|NCT01153893|P2|Participant Flow|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
337051|NCT01153893|P1|Participant Flow|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
337052|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
337053|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
337054|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
337055|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
337056|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
337057|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
337058|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
337059|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
337060|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
337061|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
337062|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
337063|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
337064|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
337065|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
337066|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
337067|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
337068|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
337069|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
337070|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
337071|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
337072|NCT01153893|E2|Reported Event|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
337073|NCT01153893|E1|Reported Event|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
337074|NCT01153841|B3|Baseline|Total|Total of all reporting groups
337075|NCT01153841|B2|Baseline|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
337076|NCT01153841|B1|Baseline|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
337077|NCT01153841|P2|Participant Flow|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
337307|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
337082|NCT01153841|O1|Outcome|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
337083|NCT01153841|O2|Outcome|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
337084|NCT01153841|O1|Outcome|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
337085|NCT01153841|O2|Outcome|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
337086|NCT01153841|O1|Outcome|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
337087|NCT01153841|O2|Outcome|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
337088|NCT01153841|O1|Outcome|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
337089|NCT01153841|E2|Reported Event|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
337090|NCT01153841|E1|Reported Event|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
337091|NCT01153815|B3|Baseline|Total|Total of all reporting groups
337092|NCT01153815|B2|Baseline|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
337093|NCT01153815|B1|Baseline|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
337094|NCT01153815|P2|Participant Flow|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
337095|NCT01153815|P1|Participant Flow|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
337096|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
337097|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
337098|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
337099|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
337100|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
337101|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
337102|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
337103|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
337104|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
337105|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
337106|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
337107|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
337108|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
337308|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337109|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
337110|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
337111|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
337112|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
337113|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
337114|NCT01153815|E2|Reported Event|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
337115|NCT01153815|E1|Reported Event|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
337116|NCT01153763|B1|Baseline|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
337117|NCT01153763|P1|Participant Flow|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
337118|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
337119|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
337120|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
337121|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
337122|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
337123|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
337124|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
337125|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
337126|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
337127|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
337128|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
337129|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
352864|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
337130|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
337131|NCT01153763|E1|Reported Event|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
337132|NCT01153724|B1|Baseline|Overall Study|Total number of patients treated in the study. This was an open-label, fixed sequence, phase I trial in healthy volunteers. 35 subjects received in period 1 Olodaterol 10 microgram delivered by Respimat inhaler once daily for 8 days and in period 2 Olodaterol 10 microgram delivered by Respimat inhaler once daily plus 1 capsule Fluconazole 400 milligram once daily, both for 14 days (with a loading dose of 800 milligram on the first day).
337133|NCT01153724|P1|Participant Flow|Overall Study|Total number of patients treated in the study. This was an open-label, fixed sequence, phase I trial in healthy volunteers. 35 subjects received in period 1 Olodaterol 10 microgram delivered by Respimat inhaler once daily for 8 days and in period 2 Olodaterol 10 microgram delivered by Respimat inhaler once daily plus 1 capsule Fluconazole 400 milligram once daily, both for 14 days (with a loading dose of 800 milligram on the first day).
337134|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
337135|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
337136|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
337137|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
337138|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
337139|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
337140|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
337141|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
337142|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
337143|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
337144|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
337145|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
337146|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
337147|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
337148|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
337149|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
337150|NCT01153724|E2|Reported Event|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
337151|NCT01153724|E1|Reported Event|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
337152|NCT01153711|B1|Baseline|Overall Study|Total number of patients treated in the study. This was an open-label, fixed sequence, phase I trial in healthy volunteers. 32 subjects received in period 1 Olodaterol 10 microgram delivered by Respimat inhaler once daily for 8 days and in period 2 Olodaterol 10 microgram delivered by Respimat inhaler once daily plus 1 tablet Ketoconazole 400mg once daily, both for 14 days.
337153|NCT01153711|P1|Participant Flow|Overall Study|Total number of patients treated in the study. This was an open-label, fixed sequence, phase I trial in healthy volunteers. 32 subjects received in period 1 Olodaterol 10 microgram delivered by Respimat inhaler once daily for 8 days and in period 2 Olodaterol 10 microgram delivered by Respimat inhaler once daily plus 1 tablet Ketoconazole 400mg once daily, both for 14 days.
337154|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
337155|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
337156|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
337157|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
337158|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
337159|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
337160|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
337161|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
337162|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
337163|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
337164|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
337165|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
337166|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
337167|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
337168|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
337169|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
337170|NCT01153711|E2|Reported Event|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
337171|NCT01153711|E1|Reported Event|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
337172|NCT01153698|B1|Baseline|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
337173|NCT01153698|P1|Participant Flow|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
337174|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
337175|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
337176|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
337177|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
337178|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
337179|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
337180|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
337181|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
337182|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
337183|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
337184|NCT01153698|E2|Reported Event|Pradaxa 220mg|All patients treated with Pradaxa
337185|NCT01153698|E1|Reported Event|Enoxaparin 40mg|All patients treated with enoxaparin
337186|NCT01153685|B3|Baseline|Total|Total of all reporting groups
337187|NCT01153685|B2|Baseline|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
337188|NCT01153685|B1|Baseline|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
337189|NCT01153685|P2|Participant Flow|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
337190|NCT01153685|P1|Participant Flow|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
337191|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
337192|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
337193|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
337194|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
337195|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
337196|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
337197|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
337198|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
337199|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
337403|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337200|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
337201|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
337202|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
337203|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
337204|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
337205|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
337206|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
337207|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
337208|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
337209|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
337210|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
337211|NCT01153685|E2|Reported Event|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
337212|NCT01153685|E1|Reported Event|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
337213|NCT01153672|B1|Baseline|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~laboratory biomarker analysis: Correlative studies~biopsy: Optional correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~positron emission tomography: Correlative studies~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~gene expression analysis: Correlative studies"
337214|NCT01153672|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~laboratory biomarker analysis: Correlative studies~biopsy: Optional correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~positron emission tomography: Correlative studies~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~gene expression analysis: Correlative studies"
337215|NCT01153672|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~laboratory biomarker analysis: Correlative studies~biopsy: Optional correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~positron emission tomography: Correlative studies~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~gene expression analysis: Correlative studies"
337216|NCT01153672|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~laboratory biomarker analysis: Correlative studies~biopsy: Optional correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~positron emission tomography: Correlative studies~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~gene expression analysis: Correlative studies"
337217|NCT01153672|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~laboratory biomarker analysis: Correlative studies~biopsy: Optional correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~positron emission tomography: Correlative studies~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~gene expression analysis: Correlative studies"
337218|NCT01153672|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~laboratory biomarker analysis: Correlative studies~biopsy: Optional correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~positron emission tomography: Correlative studies~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~gene expression analysis: Correlative studies"
337219|NCT01153672|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~laboratory biomarker analysis: Correlative studies~biopsy: Optional correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~positron emission tomography: Correlative studies~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~gene expression analysis: Correlative studies"
337309|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
337220|NCT01153672|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~laboratory biomarker analysis: Correlative studies~biopsy: Optional correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~positron emission tomography: Correlative studies~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~gene expression analysis: Correlative studies"
337221|NCT01153633|B3|Baseline|Total|Total of all reporting groups
337222|NCT01153633|B2|Baseline|Normal Saline and Placebo Gel|Sodium Choride 0.9% Solution, Neutral Gel without Polihexanide, without Betaine
337223|NCT01153633|B1|Baseline|Prontosan Wound Solution and Gel|Polihexanide (0.1%), Betaine (0,1%), Purifed water
337224|NCT01153633|P2|Participant Flow|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
337225|NCT01153633|P1|Participant Flow|Prontosan Wound Solution and Gel|Polihexanide (0.1%), Betaine (0,1%), Purifed water
337226|NCT01153633|O2|Outcome|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
337227|NCT01153633|O1|Outcome|Prontosan Wound Solution and Gel|Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
337228|NCT01153633|O2|Outcome|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
337229|NCT01153633|O1|Outcome|Prontosan Wound Solution and Gel|Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
337230|NCT01153633|O2|Outcome|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
337231|NCT01153633|O1|Outcome|Prontosan Wound Solution and Gel|Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
337232|NCT01153633|O2|Outcome|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
337233|NCT01153633|O1|Outcome|Prontosan Wound Solution and Gel|Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
337234|NCT01153633|O2|Outcome|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
337235|NCT01153633|O1|Outcome|Prontosan Wound Solution and Gel|Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
337236|NCT01153633|O2|Outcome|Normal Saline and Inactive Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
337237|NCT01153633|O1|Outcome|Prontosan Wound Irrigation Solution and Gel|Polihexanide 0.1%, Betaine 01.%, purified water, exipients
337238|NCT01153633|E2|Reported Event|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
337239|NCT01153633|E1|Reported Event|Prontosan Wound Solution and Gel|Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
337240|NCT01153620|B3|Baseline|Total|Total of all reporting groups
337241|NCT01153620|B2|Baseline|Lavasept 0.04%|
337242|NCT01153620|B1|Baseline|Ringer's Solution|
337243|NCT01153620|P2|Participant Flow|Lavasept 0.04%|
337244|NCT01153620|P1|Participant Flow|Ringer's Solution|
337245|NCT01153620|O2|Outcome|Ringer's Solution|Reduction in log 10 Colony Forming Units after 60 minutes of treatment
337246|NCT01153620|O1|Outcome|Lavasept 0.04%|Reduction in log 10 Colony Forming Units after 60 minutes of treatment
337247|NCT01153620|E2|Reported Event|Lavasept 0.04%|
337248|NCT01153620|E1|Reported Event|Ringer's Solution|
337249|NCT01153581|B1|Baseline|Women|"Estrogen and Progesterone~17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills~17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day"
337250|NCT01153581|P1|Participant Flow|Women With and Without Orthostatic Intolerance|"Estrogen and Progesterone~17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills~17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day"
337251|NCT01153581|O2|Outcome|Women Without Orthostatic Tolerance|Women who pass out easily with gravitational challenge
337252|NCT01153581|O1|Outcome|Women With Orthostatic Intolerance|"Estrogen and Progesterone~17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills~17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day"
337253|NCT01153581|O2|Outcome|High Orthostatic Tolerant|Women who can tolerate posture changes
337254|NCT01153581|O1|Outcome|Low Orthostatic Tolerance|Women who pass out easily in response to posture change
337255|NCT01153581|O1|Outcome|Women With and Without Orthostatic Intolerance|"Estrogen and Progesterone~17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills~17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day"
337256|NCT01153581|E3|Reported Event|Progesterone|The same women added progesterone (P4, 200 mg day−1 Prometrium, oral, Solvay Pharmaceuticals, Marietta, GA, USA) on days 13–16.
337257|NCT01153581|E2|Reported Event|17β-Oestradiol|The same women added 17β-Oestradiol, E2; 0.2 mg day−1 patch (Vivelle; CIBA Pharmaceuticals, Summit, NJ) for days 4-16.
337258|NCT01153581|E1|Reported Event|Ganirelix Acetate|Ganirelix acetate (Organon, Roseland, NJ, USA), a synthetic decapeptide with high antagonistic activity against naturally occurring gonadotrophin-releasing hormone (GnRH) to suppress GnRH. (250 μg in 0.5ml normal saline for 16 days).
337259|NCT01153503|B4|Baseline|Total|Total of all reporting groups
337260|NCT01153503|B3|Baseline|Ketorolac 30 mg IV|"Ketorolac 30 mg, IV at the end of surgery~First 24-h postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine"
337262|NCT01153503|B1|Baseline|Ketorolac 30 mg, IV + TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery~First 24-h postoperative: Ketorolac 30 mg, IV, every 6h + acetaminophen 650 mg, orally, every 6h + IV-PCA morphine"
337263|NCT01153503|P3|Participant Flow|Ketorolac 30 mg|"Ketorolac 30 mg, IV at the end of surgery~First 24-h Postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine 24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
337264|NCT01153503|P2|Participant Flow|TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery~First 24-h Postoperative: IV-PCA morphine~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
337265|NCT01153503|P1|Participant Flow|Ketorolac 30 mg, IV + TAP Block|"Bilateral ultrasound-guided TAP blocks and Ketorolac 30 mg IV at the end of the surgery~First 24-h Postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h and IV-PCA morphine~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
337266|NCT01153503|O3|Outcome|Ketorolac 30 mg|"Ketorolac 30 mg after surgery~First 24-h postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine"
337267|NCT01153503|O2|Outcome|TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery+ IV-PCA morphine~First 24-h postoperative: IV-PCA morphine"
337268|NCT01153503|O1|Outcome|Ketorolac 30 mg, IV + TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery~First 24-h postoperative: Ketorolac 30 mg, IV, every 6h + acetaminophen 650 mg, orally, every 6h + IV-PCA morphine"
337269|NCT01153503|E3|Reported Event|Ketorolac 30 mg|"Ketorolac 30 mg after surgery~First 24-h postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine"
337270|NCT01153503|E2|Reported Event|TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery+ IV-PCA morphine~First 24-h postoperative: IV-PCA morphine"
337271|NCT01153503|E1|Reported Event|Ketorolac 30 mg, IV + TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery~First 24-h postoperative: Ketorolac 30 mg, IV, every 6h + acetaminophen 650 mg, orally, every 6h + IV-PCA morphine"
337272|NCT01153425|B3|Baseline|Total|Total of all reporting groups
337273|NCT01153425|B2|Baseline|Zoledronic Acid (Reclast)|"5 mg of zoledronic Acid will be administered intravenously at baseline and 12 months and an MRI ('Virtual Bone Biopsy) will be performed at 0 and 24 months.~Virtual Bone Biopsy by Magnetic Resonance Imaging: The MRI involves virtual bone biopsy technology currently being developed. This new technology is not commercially or elsewhere available. It allows generation of 3D images of considerably smaller voxel size than the previous technology by employing new pulse sequences and advanced interpolation techniques. The enhanced resolution will enable capturing subtle remodeling-induced changes, such as reversal of the fenestration caused by prior osteoclastic resorption cavities. It will also permit measurement of trabecular thickness with increased accuracy and precision. Advances have also been made toward superior registration of follow-up scans relative to the baseline scans. This, we project, provides improved reproducibility and thus increased statistical power."
337274|NCT01153425|B1|Baseline|Teriparatide (Forteo)|"20 µg of Teriparatide will be self-injected subcutaneously once a day for 24 months and an MRI ('Virtual Bone Biopsy') will be performed at 0 and 24 months.~Virtual Bone Biopsy by Magnetic Resonance Imaging: The MRI involves virtual bone biopsy technology currently being developed. This new technology is not commercially or elsewhere available. It allows generation of 3D images of considerably smaller voxel size than the previous technology by employing new pulse sequences and advanced interpolation techniques. The enhanced resolution will enable capturing subtle remodeling-induced changes, such as reversal of the fenestration caused by prior osteoclastic resorption cavities. It will also permit measurement of trabecular thickness with increased accuracy and precision. Advances have also been made toward superior registration of follow-up scans relative to the baseline scans. This, we project, provides improved reproducibility and thus increased statistical power."
337275|NCT01153425|P2|Participant Flow|Zoledronic Acid (Reclast)|"5 mg of zoledronic Acid will be administered intravenously at baseline and 12 months and an MRI ('Virtual Bone Biopsy) will be performed at 0 and 24 months.~Virtual Bone Biopsy by Magnetic Resonance Imaging: The MRI involves virtual bone biopsy technology currently being developed. This new technology is not commercially or elsewhere available. It allows generation of 3D images of considerably smaller voxel size than the previous technology by employing new pulse sequences and advanced interpolation techniques. The enhanced resolution will enable capturing subtle remodeling-induced changes, such as reversal of the fenestration caused by prior osteoclastic resorption cavities. It will also permit measurement of trabecular thickness with increased accuracy and precision. Advances have also been made toward superior registration of follow-up scans relative to the baseline scans. This, we project, provides improved reproducibility and thus increased statistical power."
337276|NCT01153425|P1|Participant Flow|Teriparatide (Forteo)|"20 µg of Teriparatide will be self-injected subcutaneously once a day for 24 months and an MRI ('Virtual Bone Biopsy') will be performed at 0 and 24 months.~Virtual Bone Biopsy by Magnetic Resonance Imaging: The MRI involves virtual bone biopsy technology currently being developed. This new technology is not commercially or elsewhere available. It allows generation of 3D images of considerably smaller voxel size than the previous technology by employing new pulse sequences and advanced interpolation techniques. The enhanced resolution will enable capturing subtle remodeling-induced changes, such as reversal of the fenestration caused by prior osteoclastic resorption cavities. It will also permit measurement of trabecular thickness with increased accuracy and precision. Advances have also been made toward superior registration of follow-up scans relative to the baseline scans. This, we project, provides improved reproducibility and thus increased statistical power."
337277|NCT01153425|O2|Outcome|Zoledronic Acid (Reclast)|"5 mg of zoledronic Acid administered intravenously at baseline and 12 months and MRI performed at 0, 12, and 24 months.~The data showed strong increases in finite element derived axial stiffness and improvement in structural parameters indicative of a more connected, more plate-like topology at the 12 and 24-month time points: bone marrow density (BMD), bone volume fraction (BVF), the topological parameters surface-to-curve ratio (S/C), which is a measure of the bone’s “platelikeness”, erosion index (EI), a parameter expressing the loss of connectivity, and axial stiffness (Ezz), all changed in the direction suggesting an improvement of bone quality.~No difference was detected between the two treatment arms."
337310|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
337404|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337278|NCT01153425|O1|Outcome|Teriparatide (Forteo)|"20 µg of Teriparatide self-injected subcutaneously once a day for 24 months with MRI performed at 0 and 24 months.~The data showed strong increases in finite element derived axial stiffness and improvement in structural parameters indicative of a more connected, more plate-like topology at the 12 and 24-month time points: bone marrow density (BMD), bone volume fraction (BVF), the topological parameters surface-to-curve ratio (S/C), which is a measure of the bone’s “platelikeness”, erosion index (EI), a parameter expressing the loss of connectivity, and axial stiffness (Ezz), all changed in the direction suggesting an improvement of bone quality.~No difference was detected between the two treatment arms."
337279|NCT01153425|O2|Outcome|Zoledronic Acid (Reclast)|"5 mg of zoledronic Acid administered intravenously at baseline and 12 months and MRI performed at 0, 12, and 24 months.~The data showed strong increases in finite element derived axial stiffness and improvement in structural parameters indicative of a more connected, more plate-like topology at the 12 and 24-month time points: bone marrow density (BMD), bone volume fraction (BVF), the topological parameters surface-to-curve ratio (S/C), which is a measure of the bone’s “platelikeness”, erosion index (EI), a parameter expressing the loss of connectivity, and axial stiffness (Ezz), all changed in the direction suggesting an improvement of bone quality.~No difference was detected between the two treatment arms."
337280|NCT01153425|O1|Outcome|Teriparatide (Forteo)|"20 µg of Teriparatide self-injected subcutaneously once a day for 24 months with MRI performed at 0, 12 and 24 months.~The data showed strong increases in finite element derived axial stiffness and improvement in structural parameters indicative of a more connected, more plate-like topology at the 12 and 24-month time points: bone marrow density (BMD), bone volume fraction (BVF), the topological parameters surface-to-curve ratio (S/C), which is a measure of the bone’s “platelikeness”, erosion index (EI), a parameter expressing the loss of connectivity, and axial stiffness (Ezz), all changed in the direction suggesting an improvement of bone quality.~No difference was detected between the two treatment arms."
337281|NCT01153425|E2|Reported Event|Zoledronic Acid (Reclast)|"5 mg of zoledronic Acid will be administered intravenously at baseline and 12 months and an MRI ('Virtual Bone Biopsy) will be performed at 0 and 24 months.~Virtual Bone Biopsy: MRI technology allowing generation of 3D images with considerably smaller voxel size than previous technology through the use of novel pulse sequences and advanced interpolation techniques.~Zoledronic Acid: Participants are clinically indicated for treatment."
337282|NCT01153425|E1|Reported Event|Teriparatide (Forteo)|"20 µg of teriparatide will be self-injected subcutaneously once a day for 24 months and an MRI ('Virtual Bone Biopsy') will be performed at 0 and 24 months.~Virtual Bone Biopsy: MRI technology allowing generation of 3D images with considerably smaller voxel size than previous technology through the use of novel pulse sequences and advanced interpolation techniques.~Teriparatide: Participants are clinically indicated for treatment."
337283|NCT01153347|B5|Baseline|Total|Total of all reporting groups
337284|NCT01153347|B4|Baseline|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337285|NCT01153347|B3|Baseline|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
337286|NCT01153347|B2|Baseline|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
337287|NCT01153347|B1|Baseline|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
337288|NCT01153347|P4|Participant Flow|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337289|NCT01153347|P3|Participant Flow|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
337290|NCT01153347|P2|Participant Flow|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
337291|NCT01153347|P1|Participant Flow|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
337292|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337293|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
337294|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
337295|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
337296|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337297|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
337298|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
337299|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
337300|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337301|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
337302|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
337303|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
337304|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337305|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
337306|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
337405|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337312|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337313|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
337314|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
337315|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
337316|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337317|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
337318|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
337319|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
337320|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337321|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
337322|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
337323|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
337324|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337325|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
337326|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
337327|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
337328|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337329|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
337330|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
337331|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
337332|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337333|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
337334|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
337335|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
337336|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337337|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
337338|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
337339|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
337340|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337341|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
337342|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
337343|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
337344|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337345|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
337346|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
337347|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
337348|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337349|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
337350|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
337351|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
337352|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337353|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
352865|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
337354|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
337355|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
337356|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337357|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
337358|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
337359|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
337360|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337361|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
337362|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
337363|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
337364|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337365|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
337366|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
337367|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
337368|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337369|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
337370|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
337371|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
337372|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337373|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
337374|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
337375|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
337376|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337377|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
337378|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
337379|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
337380|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337381|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
337382|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
337383|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
337384|NCT01153347|E4|Reported Event|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
337385|NCT01153347|E3|Reported Event|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
337386|NCT01153347|E2|Reported Event|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
337387|NCT01153347|E1|Reported Event|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo
337388|NCT01153321|B3|Baseline|Total|Total of all reporting groups
337389|NCT01153321|B2|Baseline|Placebo|Placebo to match AZD2423 tablets, once daily
337390|NCT01153321|B1|Baseline|AZD2423|Two 50 mg AZD2423 tablets, once daily
337391|NCT01153321|P2|Participant Flow|Placebo|Placebo to match AZD2423 tablets, once daily
337392|NCT01153321|P1|Participant Flow|AZD2423|Two 50 mg AZD2423 tablets, once daily
337393|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337394|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337395|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337396|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337397|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337398|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337399|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337400|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337401|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337419|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337420|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337421|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337422|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337423|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337424|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337425|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337426|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337427|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337428|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337429|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337430|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337431|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337432|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337433|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337434|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337435|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337436|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337437|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337438|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337439|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337440|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337441|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337442|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337443|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337444|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337445|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337446|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337447|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337448|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337449|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337450|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337451|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337452|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337453|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337454|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337455|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337456|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337457|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337458|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337459|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337460|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337461|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337462|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337463|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337464|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337465|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337466|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337467|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337468|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337469|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337470|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337471|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337472|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337473|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337474|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337475|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337476|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337477|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337478|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337479|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337480|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337481|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337482|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337483|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337484|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337485|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337486|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337487|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337488|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337489|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337490|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337491|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337492|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337493|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337494|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337495|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337496|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337497|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337498|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337499|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
337500|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
337501|NCT01153321|E2|Reported Event|Placebo|Placebo to match AZD2423 tablets, once daily
337502|NCT01153321|E1|Reported Event|AZD2423 100 mg|
337503|NCT01153269|B1|Baseline|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
337504|NCT01153269|P1|Participant Flow|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
337505|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
337506|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
337507|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
337508|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
337509|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
337510|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
337511|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
337512|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
337513|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
337514|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
337515|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
337516|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
337517|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
337518|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
337519|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
337520|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
337521|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
337522|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
337523|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
337524|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
337525|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
337526|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
337527|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
337528|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
337529|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
337530|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
337531|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
337532|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
337533|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337534|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337535|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337536|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337537|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337538|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
338066|NCT01151215|O2|Outcome|AZD8931 20mg + Anastrozole 1mg|AZD8931 20mg (bd) plus anastrozole 1mg (od)
337539|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337540|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337541|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337542|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337543|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337544|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337545|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337546|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337547|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337548|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337549|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337550|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337551|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337552|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337553|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337554|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337555|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337556|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337557|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337558|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337559|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337560|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
337561|NCT01153269|E1|Reported Event|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
337562|NCT01153009|B5|Baseline|Total|Total of all reporting groups
337563|NCT01153009|B4|Baseline|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
337564|NCT01153009|B3|Baseline|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
337565|NCT01153009|B2|Baseline|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
337566|NCT01153009|B1|Baseline|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
337567|NCT01153009|P4|Participant Flow|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
337568|NCT01153009|P3|Participant Flow|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
337569|NCT01153009|P2|Participant Flow|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
337570|NCT01153009|P1|Participant Flow|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
337571|NCT01153009|O4|Outcome|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
337572|NCT01153009|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
337573|NCT01153009|O2|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
337574|NCT01153009|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
337575|NCT01153009|O4|Outcome|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
337576|NCT01153009|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
337577|NCT01153009|O2|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
337578|NCT01153009|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
337579|NCT01153009|O4|Outcome|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
337580|NCT01153009|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
337581|NCT01153009|O2|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
337582|NCT01153009|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
337583|NCT01153009|O4|Outcome|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
337584|NCT01153009|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
337585|NCT01153009|O2|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
337586|NCT01153009|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
337587|NCT01153009|O4|Outcome|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
337588|NCT01153009|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
337589|NCT01153009|O2|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
337590|NCT01153009|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
337591|NCT01153009|O4|Outcome|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
337592|NCT01153009|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
337593|NCT01153009|O2|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
337594|NCT01153009|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
337595|NCT01153009|E4|Reported Event|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
337596|NCT01153009|E3|Reported Event|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
337597|NCT01153009|E2|Reported Event|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
337598|NCT01153009|E1|Reported Event|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
337599|NCT01152996|B1|Baseline|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
337600|NCT01152996|P1|Participant Flow|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
337601|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
337602|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
337603|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
337604|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
337681|NCT01152554|B2|Baseline|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337605|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
337606|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
337607|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
337608|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
337609|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
337610|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
337611|NCT01152996|E1|Reported Event|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
337612|NCT01152814|B1|Baseline|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
337613|NCT01152814|P1|Participant Flow|FLUAD|Participants received a single intramuscular (IM) dose of 0.5 milliliter (mL) of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
337614|NCT01152814|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
337615|NCT01152814|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
337616|NCT01152814|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
337617|NCT01152814|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
337618|NCT01152814|E1|Reported Event|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
337619|NCT01152788|B3|Baseline|Total|Total of all reporting groups
337620|NCT01152788|B2|Baseline|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
337621|NCT01152788|B1|Baseline|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
337622|NCT01152788|P2|Participant Flow|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
337623|NCT01152788|P1|Participant Flow|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
337624|NCT01152788|O2|Outcome|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
337625|NCT01152788|O1|Outcome|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
337626|NCT01152788|O2|Outcome|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
337627|NCT01152788|O1|Outcome|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
337628|NCT01152788|O2|Outcome|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
337629|NCT01152788|O1|Outcome|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
337630|NCT01152788|O2|Outcome|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
337631|NCT01152788|O1|Outcome|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
337632|NCT01152788|E2|Reported Event|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
337633|NCT01152788|E1|Reported Event|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
337634|NCT01152697|B1|Baseline|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
337635|NCT01152697|P1|Participant Flow|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE). Dosage form was a long acting injectable administered every three to five weeks. Mean endpoint dose was 68.0 mg.
337636|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
337637|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
337638|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
337639|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
337640|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
337641|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
337642|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
337643|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
337644|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
337645|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
337646|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
337647|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
337648|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
337649|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
337650|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
337651|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
337652|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
337653|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
337654|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
337655|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
337656|NCT01152697|E1|Reported Event|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
337657|NCT01152580|B3|Baseline|Total|Total of all reporting groups
337658|NCT01152580|B2|Baseline|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
337659|NCT01152580|B1|Baseline|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
337660|NCT01152580|P2|Participant Flow|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
337661|NCT01152580|P1|Participant Flow|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
337662|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
337663|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
337664|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
337665|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
337666|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
337667|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
337668|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
337669|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
337670|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
337671|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
337672|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
337673|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
337674|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
337675|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
337676|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
337677|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
337678|NCT01152580|E2|Reported Event|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
337679|NCT01152580|E1|Reported Event|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
337680|NCT01152554|B3|Baseline|Total|Total of all reporting groups
352866|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
337682|NCT01152554|B1|Baseline|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
337683|NCT01152554|P2|Participant Flow|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337684|NCT01152554|P1|Participant Flow|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
337685|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337686|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
337687|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337688|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
337689|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337690|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
337691|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337692|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
337693|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337694|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
337695|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337696|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
337697|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337698|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
337699|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337700|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
337701|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
337702|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
337703|NCT01152554|E2|Reported Event|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
337704|NCT01152554|E1|Reported Event|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo
337705|NCT01152450|B1|Baseline|Baseline Total|Total number of patients randomised and treated in the study.
337706|NCT01152450|P6|Participant Flow|Placebo/Tio R5 qd/Tio R2.5 Bid|Patients treated with a matching Placebo in period 1 (morning and evening), with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 2 and with Tiotropium 2.5 mcg in period 3 (morning and evening) . All products were delivered by the Respimat inhaler, on top on maintenance therapy with iCS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
337707|NCT01152450|P5|Participant Flow|Placebo/Tio R2.5 Bid/Tio R5 qd|Patients treated with matching Placebo in period 1 (morning and evening), with Tiotropium 2.5 mcg in period 2 (morning and evening) and with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 3. All products were delivered by the Respimat inhaler, on top on maintenance therapy with iCS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
337708|NCT01152450|P4|Participant Flow|Tio R5 qd/Placebo/Tio R2.5 Bid|Patients treated with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 1, with matching Placebo in period 2 (morning and evening) and with Tiotropium 2.5 mcg in period 3 (morning and evening) . All products were delivered by the Respimat inhaler, on top on maintenance therapy with iCS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
337709|NCT01152450|P3|Participant Flow|Tio R5 qd/Tio R2.5 Bid/Placebo|Patients treated with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 1, with Tiotropium 2.5 mcg in period 2 (morning and evening) and with matching Placebo in period 3 (morning and evening) . All products were delivered by the Respimat inhaler, on top on maintenance therapy with iCS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
337710|NCT01152450|P2|Participant Flow|Tio R2.5 Bid/Placebo/Tio R5 qd|Patients treated with Tiotropium 2.5 mcg in period 1 (morning and evening), with a matching Placebo in period 2 (morning and evening) and with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 3. All products were delivered by the Respimat inhaler, on top on maintenance therapy with iCS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
337711|NCT01152450|P1|Participant Flow|Tio R2.5 Twice Daily (Bid) /Tio R5 Once Daily (qd) /Placebo|Patients treated with Tiotropium 2.5 mcg in period 1 (morning and evening), with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 2 and with a matching Placebo in period 3 (morning and evening). All products were delivered by the Respimat inhaler, on top on maintenance therapy with inhaled corticosteroid (iCS). No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
337712|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337713|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
338067|NCT01151215|O1|Outcome|AZD8931 40mg + Anastrozole 1mg|AZD8931 40mg (bd) plus anastrozole 1mg (od)
337714|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337715|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337716|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337717|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337718|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337719|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337720|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337721|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337722|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337723|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337724|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337725|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337726|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337727|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337728|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337729|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337730|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337731|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337732|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337733|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337734|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337735|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337736|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337737|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337738|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337739|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337740|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337741|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337742|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337743|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337744|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337745|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337746|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337747|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337748|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337749|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337750|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337751|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337752|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337753|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337754|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
338265|NCT01150461|O1|Outcome|Losartan 50 mg PO BID|
337755|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337756|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337757|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337758|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337759|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337760|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337761|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337762|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337763|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337764|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337765|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337766|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337767|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337768|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337769|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337770|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337771|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337772|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337773|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337774|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337775|NCT01152450|E3|Reported Event|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337776|NCT01152450|E2|Reported Event|Tio R2.5|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337777|NCT01152450|E1|Reported Event|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
337778|NCT01152437|B4|Baseline|Total|Total of all reporting groups
337779|NCT01152437|B3|Baseline|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
337780|NCT01152437|B2|Baseline|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
337781|NCT01152437|B1|Baseline|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
337782|NCT01152437|P3|Participant Flow|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
337783|NCT01152437|P2|Participant Flow|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
337784|NCT01152437|P1|Participant Flow|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
337785|NCT01152437|O2|Outcome|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
337786|NCT01152437|O1|Outcome|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
337787|NCT01152437|O3|Outcome|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
337788|NCT01152437|O2|Outcome|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
337789|NCT01152437|O1|Outcome|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
337790|NCT01152437|O3|Outcome|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
337791|NCT01152437|O2|Outcome|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
337792|NCT01152437|O1|Outcome|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
337793|NCT01152437|O1|Outcome|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
337794|NCT01152437|O2|Outcome|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
337795|NCT01152437|O1|Outcome|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
337796|NCT01152437|E3|Reported Event|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
337797|NCT01152437|E2|Reported Event|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
337798|NCT01152437|E1|Reported Event|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
337799|NCT01152385|B5|Baseline|Total|Total of all reporting groups
337800|NCT01152385|B4|Baseline|Placebo|Placebo
337801|NCT01152385|B3|Baseline|Low Dose|80 mg (daily dose)
337802|NCT01152385|B2|Baseline|Middle Dose|140 mg (daily dose)
337803|NCT01152385|B1|Baseline|High Dose|200 mg (daily dose)
337804|NCT01152385|P4|Participant Flow|Placebo|Placebo
337805|NCT01152385|P3|Participant Flow|Low Dose|80 mg (daily dose)
337806|NCT01152385|P2|Participant Flow|Middle Dose|140 mg (daily dose)
337807|NCT01152385|P1|Participant Flow|High Dose|200 mg (daily dose)
337808|NCT01152385|O4|Outcome|Arm 4 - Placebo|Placebo
337809|NCT01152385|O3|Outcome|Arm 3 - Low|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
337810|NCT01152385|O2|Outcome|Arm 2 - Middle|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
337811|NCT01152385|O1|Outcome|Arm 1 - High|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
337812|NCT01152385|O4|Outcome|Arm 4 - Placebo|Placebo
337813|NCT01152385|O3|Outcome|Arm 3 - Low|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
337814|NCT01152385|O2|Outcome|Arm 2 - Middle|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
337815|NCT01152385|O1|Outcome|Arm 1 - High|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
337816|NCT01152385|O4|Outcome|Arm 4 - Placebo|Placebo
337817|NCT01152385|O3|Outcome|Arm 3 - Low|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
337818|NCT01152385|O2|Outcome|Arm 2 - Middle|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
337819|NCT01152385|O1|Outcome|Arm 1 - High|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
337820|NCT01152385|O4|Outcome|Arm 4 - Placebo|Placebo
337821|NCT01152385|O3|Outcome|Arm 3 - Low|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
337822|NCT01152385|O2|Outcome|Arm 2 - Middle|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
337823|NCT01152385|O1|Outcome|Arm 1 - High|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
337824|NCT01152385|O4|Outcome|Arm 4 - Placebo|Placebo
337825|NCT01152385|O3|Outcome|Arm 3 - Low|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
337826|NCT01152385|O2|Outcome|Arm 2 - Middle|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
337827|NCT01152385|O1|Outcome|Arm 1 - High|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
337828|NCT01152385|O4|Outcome|Arm 4 - Placebo|Placebo
337829|NCT01152385|O3|Outcome|Arm 3 - Low|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
337830|NCT01152385|O2|Outcome|Arm 2 - Middle|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
337831|NCT01152385|O1|Outcome|Arm 1 - High|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
337832|NCT01152385|O4|Outcome|Arm 4 - Placebo Dose|Placebo
337833|NCT01152385|O3|Outcome|Arm 3 - Low Dose|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
337834|NCT01152385|O2|Outcome|Arm 2 - Middle Dose|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
337835|NCT01152385|O1|Outcome|Arm 1 - High Dose|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
337836|NCT01152385|O4|Outcome|Arm 4 - Placebo Dose|Placebo
337837|NCT01152385|O3|Outcome|Arm 3 - Low Dose|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
337838|NCT01152385|O2|Outcome|Arm 2 - Middle Dose|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
337839|NCT01152385|O1|Outcome|Arm 1 - High Dose|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
337840|NCT01152385|E4|Reported Event|Placebo|Placebo
337841|NCT01152385|E3|Reported Event|Low Dose|80 mg (daily dose)
337842|NCT01152385|E2|Reported Event|Middle Dose|140 mg (daily dose)
337843|NCT01152385|E1|Reported Event|High Dose|200 mg (daily dose)
337844|NCT01152359|B3|Baseline|Total|Total of all reporting groups
337845|NCT01152359|B2|Baseline|Arm 2|Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
337878|NCT01152190|O2|Outcome|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
337879|NCT01152190|O1|Outcome|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
337880|NCT01152190|O2|Outcome|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
337881|NCT01152190|O1|Outcome|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
337846|NCT01152359|B1|Baseline|Arm 1|Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
337847|NCT01152359|P2|Participant Flow|Arm 2|Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
337848|NCT01152359|P1|Participant Flow|Arm 1|Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
337849|NCT01152359|O2|Outcome|Arm 2|Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
337850|NCT01152359|O1|Outcome|Arm 1|Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
337851|NCT01152359|E2|Reported Event|Arm 2|Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
337852|NCT01152359|E1|Reported Event|Arm 1|Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
337853|NCT01152307|B3|Baseline|Total|Total of all reporting groups
337854|NCT01152307|B2|Baseline|Control|Group not receiving the decision aid (DVD/booklet)
337855|NCT01152307|B1|Baseline|Decision Aid|Group receiving the decision aid (DVD/booklet)
337856|NCT01152307|P2|Participant Flow|Control|Group not receiving the decision aid (DVD/booklet)
337857|NCT01152307|P1|Participant Flow|Decision Aid|Group receiving the decision aid (DVD/booklet)
337858|NCT01152307|O2|Outcome|Control|Group not receiving the decision aid (DVD/booklet)
337859|NCT01152307|O1|Outcome|Decision Aid|Group receiving the decision aid (DVD/booklet)
337860|NCT01152307|E2|Reported Event|Control|Group not receiving the decision aid (DVD/booklet)
337861|NCT01152307|E1|Reported Event|Decision Aid|Group receiving the decision aid (DVD/booklet)
337862|NCT01152294|B3|Baseline|Total|Total of all reporting groups
337863|NCT01152294|B2|Baseline|Decision Aid|Group receiving the decision aid (DVD/booklet)
337864|NCT01152294|B1|Baseline|Control|Group not receiving the decision aid (DVD and booklet)
337865|NCT01152294|P2|Participant Flow|Decision Aid|Group receiving the decision aid (DVD/booklet)
337866|NCT01152294|P1|Participant Flow|Control|Group not receiving the decision aid (DVD and booklet)
337867|NCT01152294|O2|Outcome|Decision Aid|Group receiving the decision aid (DVD/booklet)
337868|NCT01152294|O1|Outcome|Control|Group not receiving the decision aid (DVD and booklet)
337869|NCT01152294|E2|Reported Event|Decision Aid|Group receiving the decision aid (DVD/booklet)
337870|NCT01152294|E1|Reported Event|Control|Group not receiving the decision aid (DVD and booklet)
337871|NCT01152190|B3|Baseline|Total|Total of all reporting groups
337872|NCT01152190|B2|Baseline|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
337873|NCT01152190|B1|Baseline|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
337874|NCT01152190|P2|Participant Flow|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
337875|NCT01152190|P1|Participant Flow|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
337876|NCT01152190|O2|Outcome|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
337877|NCT01152190|O1|Outcome|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
337882|NCT01152190|O2|Outcome|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
337883|NCT01152190|O1|Outcome|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
337884|NCT01152190|E2|Reported Event|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
337885|NCT01152190|E1|Reported Event|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
337886|NCT01152112|B3|Baseline|Total|Total of all reporting groups
337887|NCT01152112|B2|Baseline|Treatment, Hospital Setting, Myomectomy|"Myomectomy for uterine polyps and/or fibroids occurring in a hospital setting~Myomectomy: Removal of fibroids and / or polyps"
337888|NCT01152112|B1|Baseline|Treatment, Office Setting, Myomectomy|"Myomectomy for uterine polyps and/or fibroids occurring in an office setting~Myomectomy: Removal of fibroids and / or polyps"
337889|NCT01152112|P2|Participant Flow|Treatment, Hospital Setting, Myomectomy|Myomectomy for uterine polyps and/or fibroids occurring in a hospital setting
337890|NCT01152112|P1|Participant Flow|Treatment, Office Setting, Myomectomy|Myomectomy for uterine polyps and/or fibroids occurring in an office setting
337891|NCT01152112|O2|Outcome|Treatment, Hospital Setting, Myomectomy|"Myomectomy for uterine polyps and/or fibroids occurring in a hospital setting~Myomectomy: Removal of fibroids and / or polyps"
337892|NCT01152112|O1|Outcome|Treatment, Office Setting, Myomectomy|"Myomectomy for uterine polyps and/or fibroids occurring in an office setting~Myomectomy: Removal of fibroids and / or polyps"
337893|NCT01152112|E2|Reported Event|Treatment, Hospital Setting, Myomectomy|"Myomectomy for uterine polyps and/or fibroids occurring in a hospital setting~Myomectomy: Removal of fibroids and / or polyps"
337894|NCT01152112|E1|Reported Event|Treatment, Office Setting, Myomectomy|"Myomectomy for uterine polyps and/or fibroids occurring in an office setting~Myomectomy: Removal of fibroids and / or polyps"
337895|NCT01151904|B1|Baseline|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
337896|NCT01151904|P1|Participant Flow|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
337897|NCT01151904|O1|Outcome|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
337898|NCT01151904|O1|Outcome|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
337899|NCT01151904|O1|Outcome|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
337900|NCT01151904|E1|Reported Event|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
337901|NCT01151852|B3|Baseline|Total|Total of all reporting groups
337902|NCT01151852|B2|Baseline|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
337903|NCT01151852|B1|Baseline|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
337904|NCT01151852|P2|Participant Flow|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
337905|NCT01151852|P1|Participant Flow|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
337906|NCT01151852|O2|Outcome|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
337907|NCT01151852|O1|Outcome|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
337908|NCT01151852|O2|Outcome|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
337909|NCT01151852|O1|Outcome|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
337910|NCT01151852|O2|Outcome|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
337911|NCT01151852|O1|Outcome|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
337912|NCT01151852|O2|Outcome|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
337913|NCT01151852|O1|Outcome|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
337914|NCT01151852|O2|Outcome|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
337915|NCT01151852|O1|Outcome|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
337916|NCT01151852|O2|Outcome|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
337917|NCT01151852|O1|Outcome|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
337918|NCT01151852|E2|Reported Event|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
337919|NCT01151852|E1|Reported Event|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
337920|NCT01151761|B1|Baseline|SBRT, Chemotherapy and Liver Transplantation|The patients received Stereotactic Body Radiotherapy and Chemotherapy followed by a liver transplantation. The chemo could be any combination of the following: Gemcitabine, Cisplatin, Carboplatin, Capecitabine and 5FU
337921|NCT01151761|P1|Participant Flow|SBRT, Chemotherapy and Liver Transplantation|The patients received Stereotactic Body Radiotherapy and Chemotherapy followed by a liver transplantation. The chemo could be any combination of the following: Gemcitabine, Cisplatin, Carboplatin, Capecitabine and 5FU
337922|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
337923|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
337924|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
337925|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
337926|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
337927|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
337928|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
337929|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
337930|NCT01151761|E1|Reported Event|SBRT, Chemotherapy and Liver Transplantation|The patients received Stereotactic Body Radiotherapy and Chemotherapy followed by a liver transplantation. The chemo could be any combination of the following: Gemcitabine, Cisplatin, Carboplatin, Capecitabine and 5FU
337931|NCT01151579|B3|Baseline|Total|Total of all reporting groups
337932|NCT01151579|B2|Baseline|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
337933|NCT01151579|B1|Baseline|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
337934|NCT01151579|P2|Participant Flow|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
337935|NCT01151579|P1|Participant Flow|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
337936|NCT01151579|O2|Outcome|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
337937|NCT01151579|O1|Outcome|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
337938|NCT01151579|O2|Outcome|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
337939|NCT01151579|O1|Outcome|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
337940|NCT01151579|O2|Outcome|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
337941|NCT01151579|O1|Outcome|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
337942|NCT01151579|E2|Reported Event|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
337943|NCT01151579|E1|Reported Event|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
337944|NCT01151553|B1|Baseline|Patients With CHF With CRT Therapy|"Patients with CHF with CRT Therapy~CRT Therapy : Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk"
337945|NCT01151553|P1|Participant Flow|Patients With CHF With CRT Therapy|"Patients with CHF with CRT Therapy~CRT Therapy : Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk"
337946|NCT01151553|O1|Outcome|Patients With CHF With CRT Therapy|"Patients with CHF with CRT Therapy~CRT Therapy : Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk"
337947|NCT01151553|E1|Reported Event|Patients With CHF With CRT Therapy|"Patients with CHF with CRT Therapy~CRT Therapy : Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk"
337948|NCT01151449|B1|Baseline|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~laboratory biomarker analysis: Correlative studies"
337949|NCT01151449|P1|Participant Flow|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~laboratory biomarker analysis: Correlative studies"
337950|NCT01151449|O1|Outcome|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~laboratory biomarker analysis: Correlative studies"
337951|NCT01151449|O1|Outcome|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~laboratory biomarker analysis: Correlative studies"
337952|NCT01151449|O1|Outcome|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~laboratory biomarker analysis: Correlative studies"
337953|NCT01151449|O1|Outcome|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~laboratory biomarker analysis: Correlative studies"
337954|NCT01151449|O1|Outcome|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~laboratory biomarker analysis: Correlative studies"
337955|NCT01151449|E1|Reported Event|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~laboratory biomarker analysis: Correlative studies"
337956|NCT01151436|B1|Baseline|Hyaluronic Acid|
337957|NCT01151436|P1|Participant Flow|Hyaluronic Acid|
337958|NCT01151436|O1|Outcome|Hyaluronic Acid|
337959|NCT01151436|O1|Outcome|Hyaluronic Acid|
337960|NCT01151436|O1|Outcome|Hyaluronic Acid|
337961|NCT01151436|O1|Outcome|Hyaluronic Acid|
337962|NCT01151436|O1|Outcome|Hyaluronic Acid|
337963|NCT01151436|O1|Outcome|Hyaluronic Acid|
337964|NCT01151436|O1|Outcome|Hyaluronic Acid|
337965|NCT01151436|O1|Outcome|Hyaluronic Acid|
337966|NCT01151436|O1|Outcome|Hyaluronic Acid|
337967|NCT01151436|O1|Outcome|Hyaluronic Acid|
337968|NCT01151436|O1|Outcome|Hyaluronic Acid|
337969|NCT01151436|O1|Outcome|Hyaluronic Acid|
337970|NCT01151436|O1|Outcome|Hyaluronic Acid|
337971|NCT01151436|O1|Outcome|Hyaluronic Acid|
337972|NCT01151436|O1|Outcome|Hyaluronic Acid|
337973|NCT01151436|O1|Outcome|Hyaluronic Acid|
337974|NCT01151436|O1|Outcome|Hyaluronic Acid|
337975|NCT01151436|O1|Outcome|Hyaluronic Acid|
337976|NCT01151436|O1|Outcome|Hyaluronic Acid|
337977|NCT01151436|O1|Outcome|Hyaluronic Acid|
337978|NCT01151436|O1|Outcome|Hyaluronic Acid|
337979|NCT01151436|O1|Outcome|Hyaluronic Acid|
337980|NCT01151436|O1|Outcome|Hyaluronic Acid|
337981|NCT01151436|O1|Outcome|Hyaluronic Acid|
337982|NCT01151436|O1|Outcome|Hyaluronic Acid|
337983|NCT01151436|O1|Outcome|Hyaluronic Acid|
337984|NCT01151436|O1|Outcome|Hyaluronic Acid|
337985|NCT01151436|E1|Reported Event|Hyaluronic Acid|
337986|NCT01151410|B3|Baseline|Total|Total of all reporting groups
337987|NCT01151410|B2|Baseline|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
337988|NCT01151410|B1|Baseline|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
337989|NCT01151410|P2|Participant Flow|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
337990|NCT01151410|P1|Participant Flow|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
338065|NCT01151215|O3|Outcome|Placebo + Anastrozole 1mg|Placebo (bd) plus anastrozole 1mg (od)
337991|NCT01151410|O2|Outcome|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
337992|NCT01151410|O1|Outcome|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
337993|NCT01151410|O2|Outcome|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
337994|NCT01151410|O1|Outcome|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
337995|NCT01151410|O2|Outcome|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
337996|NCT01151410|O1|Outcome|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
337997|NCT01151410|E2|Reported Event|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
337998|NCT01151410|E1|Reported Event|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
337999|NCT01151371|B4|Baseline|Total|Total of all reporting groups
338000|NCT01151371|B3|Baseline|Lotrafilcon B 4 Weeks|lenses worn daily on a 1-month replacement schedule, for 4 weeks
338001|NCT01151371|B2|Baseline|Nelfilcon A 1 Week|lenses worn daily on a daily disposable/replacement schedule, for 1 week
338002|NCT01151371|B1|Baseline|Narafilcon B 4 Weeks|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
338003|NCT01151371|P3|Participant Flow|Lotrafilcon B 4 Weeks|lenses worn daily on a 1-month replacement schedule, for 4 weeks
338004|NCT01151371|P2|Participant Flow|Nelfilcon A 1 Week|lenses worn daily on a daily disposable/replacement schedule, for 1 week
338005|NCT01151371|P1|Participant Flow|Narafilcon B 4 Weeks|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
338006|NCT01151371|O2|Outcome|Lotrafilcon B|lenses worn daily on a 1-month replacement schedule, for 4 weeks
338007|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
338008|NCT01151371|O2|Outcome|Lotrafilcon B|lenses worn daily on a 1-month replacement schedule, for 4 weeks
338009|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
338010|NCT01151371|O2|Outcome|Lotrafilcon B|lenses worn daily on a 1-month replacement schedule, for 4 weeks
338011|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
338012|NCT01151371|O2|Outcome|Lotrafilcon B|lenses worn daily on a 1-month replacement schedule, for 4 weeks
338013|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
338014|NCT01151371|O2|Outcome|Lotrafilcon B|lenses worn daily on a 1-month replacement schedule, for 4 weeks
338015|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
338016|NCT01151371|O2|Outcome|Nelfilcon A|lenses worn daily on a daily disposable/replacement schedule, for 1 week
338017|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
338018|NCT01151371|O2|Outcome|Nelfilcon A|lenses worn daily on a daily disposable/replacement schedule, for 1 week
338019|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
338020|NCT01151371|O2|Outcome|Nelfilcon A|lenses worn daily on a daily disposable/replacement schedule, for 1 week
338021|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
338022|NCT01151371|O2|Outcome|Nelfilcon A|lenses worn daily on a daily disposable/replacement schedule, for 1 week
338023|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
338024|NCT01151371|O2|Outcome|Lotrafilcon B|lenses worn daily on a 1-month replacement schedule, for 4 weeks
338025|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
338026|NCT01151371|O2|Outcome|Nelfilcon A|lenses worn daily on a daily disposable/replacement schedule, for 1 week
338027|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
338028|NCT01151371|O2|Outcome|Nelfilcon A|lenses worn daily on a daily disposable/replacement schedule, for 1 week
338029|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
338030|NCT01151371|E3|Reported Event|Lotrafilcon B 4 Weeks|lenses worn daily on a 1-month replacement schedule, for 4 weeks
338031|NCT01151371|E2|Reported Event|Nelfilcon A 1 Week|lenses worn daily on a daily disposable/replacement schedule, for 1 week
338032|NCT01151371|E1|Reported Event|Narafilcon B 4 Weeks|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
338033|NCT01151345|B1|Baseline|Entire Study Population|Includes groups randomized to receive any treatment (Tilazem 60 mg tablet first or Angiotrofin 60 mg tablet first )
338034|NCT01151345|P2|Participant Flow|Angiotrofin 60 mg Then Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in first intervention period and single oral dose of 60 mg Diltiazem tablet (Tilazem®) in second intervention period after 7 day clearance period.The total study duration was 9 days.
338035|NCT01151345|P1|Participant Flow|Tilazem 60 mg Then Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in first intervention period and single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in second intervention period after 7 day clearance period. The total study duration was 9 days.
338036|NCT01151345|O2|Outcome|Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
338037|NCT01151345|O1|Outcome|Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
338038|NCT01151345|O2|Outcome|Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
338039|NCT01151345|O1|Outcome|Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
338040|NCT01151345|O2|Outcome|Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
338041|NCT01151345|O1|Outcome|Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
338042|NCT01151345|O2|Outcome|Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
338043|NCT01151345|O1|Outcome|Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
338044|NCT01151345|O2|Outcome|Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
338045|NCT01151345|O1|Outcome|Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
338046|NCT01151345|E2|Reported Event|Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
338047|NCT01151345|E1|Reported Event|Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
338048|NCT01151280|B1|Baseline|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
338049|NCT01151280|P1|Participant Flow|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
338050|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
338051|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
338052|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
338053|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
338054|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
338055|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
338056|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
338057|NCT01151280|E1|Reported Event|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
338058|NCT01151215|B4|Baseline|Total|Total of all reporting groups
338059|NCT01151215|B3|Baseline|Placebo + Anastrozole 1mg|Placebo (bd) plus anastrozole 1mg (od)
338060|NCT01151215|B2|Baseline|AZD8931 20mg + Anastrozole 1mg|AZD8931 20mg (bd) plus anastrozole 1mg (od)
338061|NCT01151215|B1|Baseline|AZD8931 40mg + Anastrozole 1mg|AZD8931 40mg (bd) plus anastrozole 1mg (od)
338062|NCT01151215|P3|Participant Flow|Placebo + Anastrozole 1mg|Placebo (bd) plus anastrozole 1mg (od)
338063|NCT01151215|P2|Participant Flow|AZD8931 20mg + Anastrozole 1mg|AZD8931 20mg (bd) plus anastrozole 1mg (od)
338064|NCT01151215|P1|Participant Flow|AZD8931 40mg + Anastrozole 1mg|AZD8931 40mg (bd) plus anastrozole 1mg (od)
338068|NCT01151215|O3|Outcome|Placebo + Anastrozole 1mg|Placebo (bd) plus anastrozole 1mg (od)
338069|NCT01151215|O2|Outcome|AZD8931 20mg + Anastrozole 1mg|AZD8931 20mg (bd) plus anastrozole 1mg (od)
338070|NCT01151215|O1|Outcome|AZD8931 40mg + Anastrozole 1mg|AZD8931 40mg (bd) plus anastrozole 1mg (od)
338071|NCT01151215|E3|Reported Event|Placebo|
338072|NCT01151215|E2|Reported Event|AZD8931 40mg|
338073|NCT01151215|E1|Reported Event|AZD8931 20mg|
338074|NCT01151189|B3|Baseline|Total|Total of all reporting groups
338075|NCT01151189|B2|Baseline|MVA85A/AERAS-485|"MVA85A/AERAS-485 is a recombinant modified vaccinia virus Ankara expressing the M. tuberculosis antigen, Ag85A. Dosage of the study vaccine to be administered will be 1x10^8 pfu.~MVA85A/AERAS-485: Subjects received intradermal injection of MVA85A/AERAS-485 on Study Day 0, followed 6-9 months later by a booster injection of MVA85A/AERAS-485."
338076|NCT01151189|B1|Baseline|Placebo|Placebo: Subjects were to receive an intradermal injection placebo on Study Day 0, followed 6-9 months later by a booster injection of placebo.
338077|NCT01151189|P2|Participant Flow|MVA85A/AERAS-485|"MVA85A/AERAS-485 is a recombinant modified vaccinia virus Ankara expressing the M. tuberculosis antigen, Ag85A. Dosage of the study vaccine to be administered will be 1x10^8 pfu.~MVA85A/AERAS-485: Subjects received intradermal injection of MVA85A/AERAS-485 on Study Day 0, followed 6-9 months later by a booster injection of MVA85A/AERAS-485."
338078|NCT01151189|P1|Participant Flow|Placebo|"The placebo is a licensed product manufactured by Allermed, Inc. and is used for evaluation of delayed-type of hypersensitivity reactions in adults.~Placebo: Subjects were to receive an intradermal injection placebo on Study Day 0, followed 6-9 months later by a booster injection of placebo."
338079|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
338080|NCT01151189|O1|Outcome|Placebo|
338081|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
338082|NCT01151189|O1|Outcome|Placebo|
338083|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
338084|NCT01151189|O1|Outcome|Placebo|
338085|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
338086|NCT01151189|O1|Outcome|Placebo|
338087|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
338088|NCT01151189|O1|Outcome|Placebo|
338089|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
338090|NCT01151189|O1|Outcome|Placebo|
338091|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
338092|NCT01151189|O1|Outcome|Placebo|
338093|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
338094|NCT01151189|O1|Outcome|Placebo|
338095|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
338096|NCT01151189|O1|Outcome|Placebo|
338097|NCT01151189|E2|Reported Event|MVA85A/AERAS-485|
338098|NCT01151189|E1|Reported Event|Placebo|
338099|NCT01151137|B3|Baseline|Total|Total of all reporting groups
338100|NCT01151137|B2|Baseline|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
338101|NCT01151137|B1|Baseline|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
338102|NCT01151137|P2|Participant Flow|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
338103|NCT01151137|P1|Participant Flow|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
338104|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
338105|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
338106|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
338107|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
338108|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
338109|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
338110|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
338111|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
338112|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
338113|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
338114|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
338115|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
338116|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
338117|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
338118|NCT01151137|E2|Reported Event|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
338119|NCT01151137|E1|Reported Event|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
338120|NCT01151098|B1|Baseline|Extension Phase (BTDS 5, 10 or 20)|Buprenorphine transdermal patches (BTDS 5, 10 or 20) applied for 7-day wear.
338121|NCT01151098|P1|Participant Flow|Total Extension Phase|Buprenorphine transdermal patches (BTDS 5, 10 or 20) applied for 7-day wear.
338122|NCT01151098|O1|Outcome|Total Extension Phase|Buprenorphine transdermal patches (BTDS 5, 10, or 20) applied for 7-day wear.
338123|NCT01151098|E1|Reported Event|Total Extension Phase|Buprenorphine transdermal patches (BTDS 5, 10 or 20) applied for 7-day wear.
338124|NCT01151085|B1|Baseline|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
338125|NCT01151085|P1|Participant Flow|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
338126|NCT01151085|O3|Outcome|Severe Infection|Participants with severe infection who taking Voriconazole according to Japanese Package Insert.
338127|NCT01151085|O2|Outcome|Moderate Infection|Participants with moderate infection who taking Voriconazole according to Japanese Package Insert.
338128|NCT01151085|O1|Outcome|Mild Infection|Participants with mild infection who taking Voriconazole according to Japanese Package Insert.
338129|NCT01151085|O2|Outcome|Without Past History|Participants without Past History who taking Voriconazole according to Japanese Package Insert.
338130|NCT01151085|O1|Outcome|With Past History|Participants with Past History who taking Voriconazole according to Japanese Package Insert.
338131|NCT01151085|O3|Outcome|Severe Infection|Participants with severe infection who taking Voriconazole according to Japanese Package Insert.
338132|NCT01151085|O2|Outcome|Moderate Infection|Participants with moderate infection who taking Voriconazole according to Japanese Package Insert.
338133|NCT01151085|O1|Outcome|Mild Infection|Participants with mild infection who taking Voriconazole according to Japanese Package Insert.
338134|NCT01151085|O2|Outcome|Female|Female Participants taking Voriconazole according to Japanese Package Insert.
338135|NCT01151085|O1|Outcome|Male|Male Participants taking Voriconazole according to Japanese Package Insert.
338136|NCT01151085|O1|Outcome|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
338137|NCT01151085|O1|Outcome|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
338138|NCT01151085|O1|Outcome|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
338139|NCT01151085|E1|Reported Event|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
338140|NCT01151046|B3|Baseline|Total|Total of all reporting groups
338141|NCT01151046|B2|Baseline|Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
338142|NCT01151046|B1|Baseline|MM-121 + Exemestane|MM-121 and Exemestane: MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
338143|NCT01151046|P2|Participant Flow|Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
338144|NCT01151046|P1|Participant Flow|MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
338145|NCT01151046|O2|Outcome|Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
338146|NCT01151046|O1|Outcome|MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
338147|NCT01151046|O4|Outcome|HRG Low: MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
338148|NCT01151046|O3|Outcome|HRG Low: Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
338149|NCT01151046|O2|Outcome|HRG High: Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
338150|NCT01151046|O1|Outcome|HRG High: MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
338151|NCT01151046|O2|Outcome|Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
338152|NCT01151046|O1|Outcome|MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
338153|NCT01151046|E2|Reported Event|Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
338154|NCT01151046|E1|Reported Event|MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
338155|NCT01151020|B1|Baseline|Zenith® TX2® Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
338156|NCT01151020|P1|Participant Flow|Zenith® TX2® Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
338157|NCT01151020|O1|Outcome|Zenith® TX2® Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
338158|NCT01151020|O1|Outcome|Zenith® TX2® Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
338159|NCT01151020|E1|Reported Event|Zenith® TX2® Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
338160|NCT01150981|B3|Baseline|Total|Total of all reporting groups
338161|NCT01150981|B2|Baseline|Placebo|One capsule daily for 6 weeks.
338162|NCT01150981|B1|Baseline|Rosiglitazone|One 8mg capsule daily for 6 weeks.
338163|NCT01150981|P2|Participant Flow|Placebo|One capsule daily for 6 weeks.
338164|NCT01150981|P1|Participant Flow|Rosiglitazone|One 8mg capsule daily for 6 weeks.
338165|NCT01150981|O2|Outcome|Placebo|One capsule daily for 6 weeks.
338166|NCT01150981|O1|Outcome|Rosiglitazone|One 8mg capsule daily for 6 weeks.
338167|NCT01150981|O2|Outcome|Placebo|One capsule daily for 6 weeks.
338168|NCT01150981|O1|Outcome|Rosiglitazone|One 8mg capsule daily for 6 weeks.
338169|NCT01150981|E2|Reported Event|Placebo|One capsule daily for 6 weeks.
338170|NCT01150981|E1|Reported Event|Rosiglitazone|One 8mg capsule daily for 6 weeks.
338171|NCT01150903|B3|Baseline|Total|Total of all reporting groups
338172|NCT01150903|B2|Baseline|Control (Without PDE5i Prescription)|Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).
338173|NCT01150903|B1|Baseline|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
338174|NCT01150903|P2|Participant Flow|Control (Without PDE5i Prescription)|Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).
338175|NCT01150903|P1|Participant Flow|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
338176|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
338177|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
338178|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
338179|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
338180|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
338181|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
338182|NCT01150903|O2|Outcome|Control (Without PDE5i Prescription)|Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).
338183|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
338184|NCT01150903|O2|Outcome|Control (Without PDE5i Prescription)|Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).
338185|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
338186|NCT01150903|E2|Reported Event|Control (Without PDE5i Prescription)|Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).
338187|NCT01150903|E1|Reported Event|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
338188|NCT01150760|B3|Baseline|Total|Total of all reporting groups
338189|NCT01150760|B2|Baseline|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
338190|NCT01150760|B1|Baseline|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
338191|NCT01150760|P2|Participant Flow|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
338192|NCT01150760|P1|Participant Flow|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
338193|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
338194|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
338195|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
338196|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
338197|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
338198|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
338199|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
338200|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
338201|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
338202|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
338203|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
338204|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
338205|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
338206|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
338207|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
338208|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
338209|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
338210|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
338211|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
338212|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
338213|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
338214|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
338215|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
338216|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
338217|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
338218|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
338219|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
338220|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
338221|NCT01150760|E2|Reported Event|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
338222|NCT01150760|E1|Reported Event|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
338223|NCT01150500|B1|Baseline|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
338224|NCT01150500|P1|Participant Flow|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
338225|NCT01150500|O1|Outcome|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
338226|NCT01150500|O1|Outcome|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
338227|NCT01150500|O1|Outcome|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
338266|NCT01150461|E2|Reported Event|Placebo|
338267|NCT01150461|E1|Reported Event|Losartan 50 PO mg BID|
338228|NCT01150500|O1|Outcome|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
338229|NCT01150500|O1|Outcome|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
338230|NCT01150500|O1|Outcome|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
338231|NCT01150500|E1|Reported Event|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
338232|NCT01150474|B3|Baseline|Total|Total of all reporting groups
338233|NCT01150474|B2|Baseline|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
338234|NCT01150474|B1|Baseline|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
338235|NCT01150474|P2|Participant Flow|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
338236|NCT01150474|P1|Participant Flow|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
338237|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
338238|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
338239|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
338240|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
338241|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
338242|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
338243|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
338244|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
338245|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
338246|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
338247|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
338248|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
338249|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
338250|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
338251|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
338252|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
338253|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
338254|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
338255|NCT01150474|E2|Reported Event|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
338256|NCT01150474|E1|Reported Event|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
338257|NCT01150461|B3|Baseline|Total|Total of all reporting groups
338258|NCT01150461|B2|Baseline|Placebo|
338259|NCT01150461|B1|Baseline|Losartan 50 mg PO BID|
338260|NCT01150461|P2|Participant Flow|Placebo|
338261|NCT01150461|P1|Participant Flow|Losartan 50 mg BID|
338262|NCT01150461|O2|Outcome|Placebo|
338263|NCT01150461|O1|Outcome|Losartan 50 mg PO BID|
338264|NCT01150461|O2|Outcome|Placebo|
338269|NCT01150409|B2|Baseline|Normal Saline (Placebo)|"0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
338270|NCT01150409|B1|Baseline|Hydrocortisone|"Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
338271|NCT01150409|P2|Participant Flow|Normal Saline (Placebo)|"0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
338272|NCT01150409|P1|Participant Flow|Hydrocortisone|"Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
338273|NCT01150409|O2|Outcome|Normal Saline (Placebo)|"0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
338274|NCT01150409|O1|Outcome|Hydrocortisone|"Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
338275|NCT01150409|E2|Reported Event|Normal Saline (Placebo)|"0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
338276|NCT01150409|E1|Reported Event|Hydrocortisone|"Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
338277|NCT01150357|B4|Baseline|Total|Total of all reporting groups
338278|NCT01150357|B3|Baseline|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
338279|NCT01150357|B2|Baseline|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
338280|NCT01150357|B1|Baseline|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight greater than or equal to (≥) 20 kilogram (kg) to less than (< ) 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and less than or equal to (≤)150 kg received 25 mg of aliskiren.
338281|NCT01150357|P3|Participant Flow|Aliskiren High (150/300/600 mg)|"During Phase 1: Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.~During Phase 2: 50 participants continued the aliskiren treatment from Phase 1, while 52 participants switched to placebo treatment."
338282|NCT01150357|P2|Participant Flow|Aliskiren Mid (37.5/75/150 mg)|"During Phase 1: Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.~During Phase 2: 30 participants continued the aliskiren treatment from Phase 1, while 21 participants switched to placebo treatment."
338283|NCT01150357|P1|Participant Flow|Aliskiren Low (6.25/12.5/25 mg)|"During Phase 1: Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.~During Phase 2: 50 participants continued the aliskiren treatment from Phase 1, while 57 participants switched to placebo treatment."
338284|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
338285|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
338368|NCT01150123|P13|Participant Flow|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
338286|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
338287|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
338288|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
338289|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
338290|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
338291|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
338292|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
338293|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
338294|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
338295|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
338296|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
338297|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
338298|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
338299|NCT01150357|O6|Outcome|Phase 2: Placebo High|Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
338300|NCT01150357|O5|Outcome|Phase 2: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
338301|NCT01150357|O4|Outcome|Phase 2: Placebo Mid|Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
338302|NCT01150357|O3|Outcome|Phase 2: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
338303|NCT01150357|O2|Outcome|Phase 2: Placebo Low|Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
338304|NCT01150357|O1|Outcome|Phase 2: Aliskiren Low (6.25/12.5/25 mg)|Participants received body­weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
338305|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
338306|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
338307|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
338308|NCT01150357|O6|Outcome|Phase 2: Placebo High|Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
338370|NCT01150123|P11|Participant Flow|5 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
338309|NCT01150357|O5|Outcome|Phase 2: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
338310|NCT01150357|O4|Outcome|Phase 2: Placebo Mid|Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
338311|NCT01150357|O3|Outcome|Phase 2: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
338312|NCT01150357|O2|Outcome|Phase 2: Placebo Low|Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
338313|NCT01150357|O1|Outcome|Phase 2: Aliskiren Low (6.25/12.5/25 mg)|Participants received body­weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
338314|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
338315|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
338316|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
338317|NCT01150357|O6|Outcome|Phase 2: Placebo High|Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
338318|NCT01150357|O5|Outcome|Phase 2: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
338319|NCT01150357|O4|Outcome|Phase 2: Placebo Mid|Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
338320|NCT01150357|O3|Outcome|Phase 2: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
338321|NCT01150357|O2|Outcome|Phase 2: Placebo Low|Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
338322|NCT01150357|O1|Outcome|Phase 2: Aliskiren Low (6.25/12.5/25 mg)|Participants received body­weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
338323|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
338324|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
338325|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
338326|NCT01150357|O6|Outcome|Phase 2: Placebo High|Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
338327|NCT01150357|O5|Outcome|Phase 2: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
338328|NCT01150357|O4|Outcome|Phase 2: Placebo Mid|Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
338329|NCT01150357|O3|Outcome|Phase 2: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
338330|NCT01150357|O2|Outcome|Phase 2: Placebo Low|Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
338331|NCT01150357|O1|Outcome|Phase 2: Aliskiren Low (6.25/12.5/25 mg)|Participants received body­weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
338332|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
338333|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
338369|NCT01150123|P12|Participant Flow|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
352867|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
338334|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
338335|NCT01150357|E9|Reported Event|Phase 2: Placebo High|Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
338336|NCT01150357|E8|Reported Event|Phase 2: Placebo Mid|Participants received placebo capsules matching to aliskiren capsules(37.5/75/150 mg) once daily.
338337|NCT01150357|E7|Reported Event|Phase 2: Placebo Low|Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
338338|NCT01150357|E6|Reported Event|Phase 2: Aliskiren High (150/300/600 mg)|"Participants received bodyweight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and~≤ 150 kg received 600 mg of aliskiren."
338339|NCT01150357|E5|Reported Event|Phase 2: Aliskiren Mid (37.5/75/150 mg)|Participants received bodyweight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
338340|NCT01150357|E4|Reported Event|Phase 2: Aliskiren Low (6.25/12.5/25 mg)|Participants received bodyweight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
338341|NCT01150357|E3|Reported Event|Phase 1: Aliskiren High (150/300/600 mg)|Participants received bodyweight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
338342|NCT01150357|E2|Reported Event|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received bodyweight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
338343|NCT01150357|E1|Reported Event|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received bodyweight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
338344|NCT01150123|B19|Baseline|Total|Total of all reporting groups
338345|NCT01150123|B18|Baseline|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
338346|NCT01150123|B17|Baseline|20 μg-2 Inj-MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
338347|NCT01150123|B16|Baseline|20 μg-1 Inj –MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
338348|NCT01150123|B15|Baseline|5μg-2 Inj –MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
338349|NCT01150123|B14|Baseline|5μg-1 Inj –MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
338350|NCT01150123|B13|Baseline|20 μg-2 Inj –MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
338351|NCT01150123|B12|Baseline|20 μg-1 Inj –MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
338352|NCT01150123|B11|Baseline|5μg-2 Inj –MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
338353|NCT01150123|B10|Baseline|5μg-1 Inj –MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
338354|NCT01150123|B9|Baseline|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart t
338355|NCT01150123|B8|Baseline|20 μg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
338356|NCT01150123|B7|Baseline|20 μg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
338357|NCT01150123|B6|Baseline|5μg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
338358|NCT01150123|B5|Baseline|5μg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
338359|NCT01150123|B4|Baseline|20 μg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
338360|NCT01150123|B3|Baseline|20 μg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
338361|NCT01150123|B2|Baseline|5μg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
338362|NCT01150123|B1|Baseline|5μg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
338363|NCT01150123|P18|Participant Flow|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
338364|NCT01150123|P17|Participant Flow|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
338365|NCT01150123|P16|Participant Flow|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
338366|NCT01150123|P15|Participant Flow|5 µg-2 Inj – MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
338367|NCT01150123|P14|Participant Flow|5 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
338575|NCT01150097|E5|Reported Event|TAC Elimination, Month 48|TAC Elimination, Month 48
338371|NCT01150123|P10|Participant Flow|5 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
338372|NCT01150123|P9|Participant Flow|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
338373|NCT01150123|P8|Participant Flow|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
338374|NCT01150123|P7|Participant Flow|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
338375|NCT01150123|P6|Participant Flow|5 µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
338376|NCT01150123|P5|Participant Flow|5 µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
338377|NCT01150123|P4|Participant Flow|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
338378|NCT01150123|P3|Participant Flow|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
338379|NCT01150123|P2|Participant Flow|5 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
338380|NCT01150123|P1|Participant Flow|5 µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
338381|NCT01150123|O9|Outcome|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
338382|NCT01150123|O8|Outcome|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
338383|NCT01150123|O7|Outcome|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
338384|NCT01150123|O6|Outcome|5µg-2 Inj – MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
338385|NCT01150123|O5|Outcome|5µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
338386|NCT01150123|O4|Outcome|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
338387|NCT01150123|O3|Outcome|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
338388|NCT01150123|O2|Outcome|5µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
338389|NCT01150123|O1|Outcome|5µg-1 Inj – MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
338390|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
338391|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
338392|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
338393|NCT01150123|O6|Outcome|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
338394|NCT01150123|O5|Outcome|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
338395|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
338396|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
338397|NCT01150123|O2|Outcome|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
338398|NCT01150123|O1|Outcome|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
338399|NCT01150123|O9|Outcome|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
338400|NCT01150123|O8|Outcome|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
338401|NCT01150123|O7|Outcome|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
338402|NCT01150123|O6|Outcome|5µg-2 Inj – MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
338403|NCT01150123|O5|Outcome|5µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
338404|NCT01150123|O4|Outcome|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
338405|NCT01150123|O3|Outcome|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
338406|NCT01150123|O2|Outcome|5µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
338407|NCT01150123|O1|Outcome|5µg-1 Inj – MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
338408|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
338409|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
338410|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
338411|NCT01150123|O6|Outcome|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
338412|NCT01150123|O5|Outcome|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
338413|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
338414|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
338415|NCT01150123|O2|Outcome|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
338416|NCT01150123|O1|Outcome|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
338417|NCT01150123|O9|Outcome|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
338418|NCT01150123|O8|Outcome|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
338419|NCT01150123|O7|Outcome|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
338420|NCT01150123|O6|Outcome|5µg-2 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
338421|NCT01150123|O5|Outcome|5µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
338422|NCT01150123|O4|Outcome|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
338423|NCT01150123|O3|Outcome|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
338424|NCT01150123|O2|Outcome|5µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
338425|NCT01150123|O1|Outcome|5µg-1 Inj – MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
338426|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
338427|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
338428|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
338429|NCT01150123|O6|Outcome|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
338430|NCT01150123|O5|Outcome|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
338431|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
338432|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
338433|NCT01150123|O2|Outcome|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
338434|NCT01150123|O1|Outcome|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
338435|NCT01150123|O9|Outcome|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
338436|NCT01150123|O8|Outcome|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
338437|NCT01150123|O7|Outcome|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
338438|NCT01150123|O6|Outcome|5µg-2 Inj – MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
338439|NCT01150123|O5|Outcome|5µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
338440|NCT01150123|O4|Outcome|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
338441|NCT01150123|O3|Outcome|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
338442|NCT01150123|O2|Outcome|5µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
338443|NCT01150123|O1|Outcome|5µg-1 Inj – MF59_H|Subjects received single active vaccine injection adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
338444|NCT01150123|O18|Outcome|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
338445|NCT01150123|O17|Outcome|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
338446|NCT01150123|O16|Outcome|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
338447|NCT01150123|O15|Outcome|5µg-2 Inj – MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
338448|NCT01150123|O14|Outcome|5µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
338449|NCT01150123|O13|Outcome|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
338490|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
338450|NCT01150123|O12|Outcome|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
338451|NCT01150123|O11|Outcome|5µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
338452|NCT01150123|O10|Outcome|5µg-1 Inj – MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
338453|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
338454|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
338455|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
338456|NCT01150123|O6|Outcome|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
338457|NCT01150123|O5|Outcome|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
338458|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
338459|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
338460|NCT01150123|O2|Outcome|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
338461|NCT01150123|O1|Outcome|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
338462|NCT01150123|O18|Outcome|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
338463|NCT01150123|O17|Outcome|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
338464|NCT01150123|O16|Outcome|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
338465|NCT01150123|O15|Outcome|5 µg-2 Inj – MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
338466|NCT01150123|O14|Outcome|5 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
338467|NCT01150123|O13|Outcome|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
338468|NCT01150123|O12|Outcome|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
338469|NCT01150123|O11|Outcome|5 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
338470|NCT01150123|O10|Outcome|5 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
338471|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
338472|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
338473|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
338474|NCT01150123|O6|Outcome|5 µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
338475|NCT01150123|O5|Outcome|5 µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
338476|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
338477|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
338478|NCT01150123|O2|Outcome|5 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
338479|NCT01150123|O1|Outcome|5 µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
338480|NCT01150123|O18|Outcome|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
338481|NCT01150123|O17|Outcome|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
338482|NCT01150123|O16|Outcome|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
338483|NCT01150123|O15|Outcome|5µg-2 Inj – MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
338484|NCT01150123|O14|Outcome|5µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
338485|NCT01150123|O13|Outcome|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
338486|NCT01150123|O12|Outcome|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
338487|NCT01150123|O11|Outcome|5µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
338488|NCT01150123|O10|Outcome|5µg-1 Inj – MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
338489|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
338491|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
338492|NCT01150123|O6|Outcome|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
338493|NCT01150123|O5|Outcome|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
338494|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
338495|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
338496|NCT01150123|O2|Outcome|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
338497|NCT01150123|O1|Outcome|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
338498|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
338499|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
338500|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
338501|NCT01150123|O6|Outcome|5 µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
338502|NCT01150123|O5|Outcome|5 µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
338503|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
338504|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
338505|NCT01150123|O2|Outcome|5 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
338506|NCT01150123|O1|Outcome|5 µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
338507|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
338508|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
338509|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
338510|NCT01150123|O6|Outcome|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
338511|NCT01150123|O5|Outcome|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
338512|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
338513|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
338514|NCT01150123|O2|Outcome|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
338515|NCT01150123|O1|Outcome|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
338516|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
338517|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
338518|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
338519|NCT01150123|O6|Outcome|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
338520|NCT01150123|O5|Outcome|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
338521|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
338522|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
338523|NCT01150123|O2|Outcome|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
338524|NCT01150123|O1|Outcome|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
338525|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
338526|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
338527|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
338528|NCT01150123|O6|Outcome|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
338529|NCT01150123|O5|Outcome|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
338530|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
338531|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
338532|NCT01150123|O2|Outcome|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
338533|NCT01150123|O1|Outcome|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
338534|NCT01150123|E18|Reported Event|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
338535|NCT01150123|E17|Reported Event|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
338536|NCT01150123|E16|Reported Event|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
338537|NCT01150123|E15|Reported Event|5µg-2 Inj – MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
338538|NCT01150123|E14|Reported Event|5µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
338539|NCT01150123|E13|Reported Event|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
338540|NCT01150123|E12|Reported Event|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
338541|NCT01150123|E11|Reported Event|5µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
338542|NCT01150123|E10|Reported Event|5µg-1 Inj – MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
338543|NCT01150123|E9|Reported Event|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
338544|NCT01150123|E8|Reported Event|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
338545|NCT01150123|E7|Reported Event|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
338546|NCT01150123|E6|Reported Event|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
338547|NCT01150123|E5|Reported Event|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
338548|NCT01150123|E4|Reported Event|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
338549|NCT01150123|E3|Reported Event|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
338550|NCT01150123|E2|Reported Event|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
338551|NCT01150123|E1|Reported Event|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
338552|NCT01150097|B4|Baseline|Total|Total of all reporting groups
338553|NCT01150097|B3|Baseline|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
338554|NCT01150097|B2|Baseline|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
338555|NCT01150097|B1|Baseline|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
338556|NCT01150097|P3|Participant Flow|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
338557|NCT01150097|P2|Participant Flow|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
338558|NCT01150097|P1|Participant Flow|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
338559|NCT01150097|O3|Outcome|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
338560|NCT01150097|O2|Outcome|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
338561|NCT01150097|O1|Outcome|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
338562|NCT01150097|O3|Outcome|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
338563|NCT01150097|O2|Outcome|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
338564|NCT01150097|O1|Outcome|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
338565|NCT01150097|O2|Outcome|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
338566|NCT01150097|O1|Outcome|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
338567|NCT01150097|O3|Outcome|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
338568|NCT01150097|O2|Outcome|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
338569|NCT01150097|O1|Outcome|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
338570|NCT01150097|O2|Outcome|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
338571|NCT01150097|O1|Outcome|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
338572|NCT01150097|O3|Outcome|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
338573|NCT01150097|O2|Outcome|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
338574|NCT01150097|O1|Outcome|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
338576|NCT01150097|E4|Reported Event|Reduced RAD + TAC, Month 48|Reduced RAD + TAC, Month 48
338577|NCT01150097|E3|Reported Event|TAC Control, Month 36|TAC Control, Month 36
338578|NCT01150097|E2|Reported Event|TAC Elimination, Month 36|TAC Elimination, Month 36
338579|NCT01150097|E1|Reported Event|Reduced TAC, Month 36|Reduced TAC, Month 36
338580|NCT01149876|B5|Baseline|Total|Total of all reporting groups
338581|NCT01149876|B4|Baseline|Proprietary Topical Plus Iontophoresis|
338582|NCT01149876|B3|Baseline|Tretinoin|
338583|NCT01149876|B2|Baseline|Placebo|
338584|NCT01149876|B1|Baseline|Proprietary Topical|
338585|NCT01149876|P4|Participant Flow|Nu Skin Product With Galvanic Spa System|
338586|NCT01149876|P3|Participant Flow|Tretinoin Cream 0.05|
338587|NCT01149876|P2|Participant Flow|Over the Counter Moisturizer|CeraVe Moisturizer
338588|NCT01149876|P1|Participant Flow|Nu Skin Product|
338589|NCT01149876|O4|Outcome|Nu Skin Product With Galvanic Spa System|
338590|NCT01149876|O3|Outcome|Tretinoin Cream 0.05|
338591|NCT01149876|O2|Outcome|Over the Counter Moisturizer|
338592|NCT01149876|O1|Outcome|Nu Skin Product|
338593|NCT01149876|O4|Outcome|Nu Skin Product With Galvanic Spa System|
338594|NCT01149876|O3|Outcome|Tretinoin Cream 0.05|
338595|NCT01149876|O2|Outcome|Over the Counter Moisturizer|CeraVe cream
338596|NCT01149876|O1|Outcome|Nu Skin Product|
338597|NCT01149876|E4|Reported Event|Proprietary Topical Plus Iontophoresis|
338598|NCT01149876|E3|Reported Event|Tretinoin|
338599|NCT01149876|E2|Reported Event|Placebo|
338600|NCT01149876|E1|Reported Event|Proprietary Topical|
338601|NCT01149863|B1|Baseline|Plerixafor 17 Hours Prior to Apheresis|"Dosing of plerixafor will occur at 3PM (1500 hours).~Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses."
338602|NCT01149863|P1|Participant Flow|Plerixafor 17 Hours Prior to Apheresis|"Dosing of plerixafor will occur at 3PM (1500 hours).~Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses."
338603|NCT01149863|O1|Outcome|Plerixafor 17 Hours Prior to Apheresis|"Dosing of plerixafor will occur at 3PM (1500 hours).~Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses."
338604|NCT01149863|O1|Outcome|Plerixafor 17 Hours Prior to Apheresis|"Dosing of plerixafor will occur at 3PM (1500 hours).~Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses."
338605|NCT01149863|E1|Reported Event|Plerixafor 17 Hours Prior to Apheresis|"Dosing of plerixafor will occur at 3PM (1500 hours).~Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses."
338606|NCT01149785|B1|Baseline|Entire Study Population|Includes participants randomized to receive Crizotinib 150 mg IRT first and then Crizotinib 150 mg + Ketoconazole 200 mg BID
338607|NCT01149785|P2|Participant Flow|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet twice daily (BID), orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period. A washout period of at least 14 days was maintained between each period.
338608|NCT01149785|P1|Participant Flow|Crizotinib 150 mg|Single oral dose of crizotinib 150 milligram (mg) immediate-release tablet (IRT) on Day 1 in first intervention period. A washout period of at least 14 days was maintained between each period.
338609|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
338610|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
338611|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
338612|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
338613|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
338614|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
338615|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
338616|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
338617|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
338618|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
338619|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
338620|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
338621|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
338622|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
338663|NCT01149733|B3|Baseline|Total|Total of all reporting groups
338664|NCT01149733|B2|Baseline|Flomax®|0.4 mg Capsule
338623|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
338624|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
338625|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
338626|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
338627|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
338628|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
338629|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
338630|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
338631|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
338632|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
338633|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
338634|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
338635|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
338636|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
338637|NCT01149785|E2|Reported Event|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
338638|NCT01149785|E1|Reported Event|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
338639|NCT01149772|B3|Baseline|Total|Total of all reporting groups
338640|NCT01149772|B2|Baseline|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
338641|NCT01149772|B1|Baseline|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. After completion of the active treatment sessions, the participant will receive 2 brief follow-up booster calls. The follow up calls provide the opportunity for the participant to review skills learned, address any questions or difficulties, and reinforce changes made. Each active treatment session lasts 30 - 40 minutes and the booster calls last 10 - 15 minute.
338642|NCT01149772|P2|Participant Flow|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
338643|NCT01149772|P1|Participant Flow|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
338644|NCT01149772|O2|Outcome|Enhanced Usual Care|Patients in this arm received feedback about their physical and emotional health functioning and were still able to receive usual primary care services.
338645|NCT01149772|O1|Outcome|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
338646|NCT01149772|O2|Outcome|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
338665|NCT01149733|B1|Baseline|Tamsulosin|0.4 mg Capsule
338666|NCT01149733|P2|Participant Flow|Flomax®|0.4 mg Capsule
338667|NCT01149733|P1|Participant Flow|Tamsulosin|0.4 mg Capsule
338668|NCT01149733|O2|Outcome|Flomax®|0.4 mg Capsule
338669|NCT01149733|O1|Outcome|Tamsulosin|0.4 mg Capsule
338670|NCT01149733|O2|Outcome|Flomax®|0.4 mg Capsule
338671|NCT01149733|O1|Outcome|Tamsulosin|0.4 mg Capsule
338672|NCT01149733|O2|Outcome|Flomax®|0.4 mg Capsule
338673|NCT01149733|O1|Outcome|Tamsulosin|0.4 mg Capsule
338647|NCT01149772|O1|Outcome|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls. The follow up calls provide the opportunity for the participant to review skills learned, address any questions or difficulties, and reinforce changes made.
338648|NCT01149772|O2|Outcome|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
338649|NCT01149772|O1|Outcome|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls. The follow up calls provide the opportunity for the participant to review skills learned, address any questions or difficulties, and reinforce changes made.
338650|NCT01149772|O2|Outcome|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
338651|NCT01149772|O1|Outcome|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls. The follow up calls provide the opportunity for the participant to review skills learned, address any questions or difficulties, and reinforce changes made.
338652|NCT01149772|O2|Outcome|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
338653|NCT01149772|O1|Outcome|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
338654|NCT01149772|O2|Outcome|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
338655|NCT01149772|O1|Outcome|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
338656|NCT01149772|E2|Reported Event|Enhanced Usual Care|Patients in this arm received feedback about their physical and emotional health functioning and were still able to receive usual primary care services.
338657|NCT01149772|E1|Reported Event|ACCESS|ACCESS: Participants received 6 treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completing core modules the participant was able to choose elective modules from Managing Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Relaxation. Participants were required to complete the first session in person and subsequent sessions participants had the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
338658|NCT01149759|B1|Baseline|Cyclosporine A|"5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks.~Cyclosporine A: 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks"
338659|NCT01149759|P1|Participant Flow|Cyclosporine A|"5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks.~Cyclosporine A: 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks"
338660|NCT01149759|O1|Outcome|Cyclosporine A|"5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks.~Cyclosporine A: 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks"
338661|NCT01149759|O1|Outcome|Cyclosporine A|"5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks.~Cyclosporine A: 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks"
338662|NCT01149759|E1|Reported Event|Cyclosporine A|"5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks.~Cyclosporine A: 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks"
338677|NCT01149655|B2|Baseline|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
338678|NCT01149655|B1|Baseline|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
338679|NCT01149655|P4|Participant Flow|Aripiprazole-Placebo-DB Maintenance|Participants who met stability criteria in period 2 (stabilization phase) received placebo for 52 Weeks in period 3 (double-blind maintenance treatment).
338680|NCT01149655|P3|Participant Flow|Aripiprazole-Double Blind (DB) Maintenance|Participants who met stability criteria in period 2 (stabilization phase) received oral aripiprazole 10 to 30 mg/day for 52 Weeks in period 3 (double-blind maintenance treatment).
338681|NCT01149655|P2|Participant Flow|Aripiprazole-Stabilization Phase|Participants who had converted to aripiprazole monotherapy period 1 (conversion phase) and had received aripiprazole monotherapy for schizophrenia at screening were in period 2, provided the prescribed aripiprazole dose did not exceed 30 mg (milligrams) per day for 2 Weeks.
338682|NCT01149655|P1|Participant Flow|Aripiprazole-Conversion Phase|Participants who had received oral aripiprazole 2 to 10 mg for 2 Weeks in combination with any other antipsychotic were in conversion phase.
338683|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
338684|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
338685|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
338686|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
338687|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
338688|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
338689|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
338690|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
338691|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
338692|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
338693|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
338694|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
338695|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
338696|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
338697|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
338698|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
338699|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
338700|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
338701|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
338702|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
338703|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
338704|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
338848|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338705|NCT01149655|E4|Reported Event|Placebo-Double Blind Maintenance Treatment|Participants who met stability criteria in period 2 (stabilization phase) had received placebo for 52 Weeks in period 3 (double-blind maintenance treatment).
338706|NCT01149655|E3|Reported Event|Aripiprazole-Double Blind Maintenance Treatment|Participants who met stability criteria in period 2 (stabilization phase) had received oral aripiprazole 10 to 30 mg/day for 52 Weeks in period 3 (double-blind maintenance treatment).
338707|NCT01149655|E2|Reported Event|Arpiprazole-Stabilization Phase|Participants who had converted to aripiprazole monotherapy period 1 (conversion phase) and had received aripiprazole monotherapy for schizophrenia at screening were in period 2, provided the prescribed aripiprazole dose did not exceed 30 mg (milligrams) per day for 2 Weeks.
338708|NCT01149655|E1|Reported Event|Aripiprazole-Conversion Phase|Participants had received oral aripiprazole 2 to 10 mg for 2 Weeks in combination with any other antipsychotic were in conversion phase.
338709|NCT01149616|B3|Baseline|Total|Total of all reporting groups
338710|NCT01149616|B2|Baseline|Placebo|"placebo~placebo: placebo administered IV x1"
338711|NCT01149616|B1|Baseline|Intervention|"Dexamethasone 8mg iv x 1~Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1"
338712|NCT01149616|P2|Participant Flow|Placebo|"placebo~placebo: placebo administered IV x1"
338713|NCT01149616|P1|Participant Flow|Intervention|"Dexamethasone 8mg iv x 1~Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1"
338714|NCT01149616|O2|Outcome|Placebo|placebo: 2 ml normal saline IV x1
338715|NCT01149616|O1|Outcome|Intervention|Dexamethasone 8mg iv x 1
338716|NCT01149616|O2|Outcome|Placebo|placebo: 2 ml normal saline IV x1
338717|NCT01149616|O1|Outcome|Intervention|Dexamethasone 8mg iv x 1
338718|NCT01149616|O2|Outcome|Placebo|"placebo~placebo: placebo administered IV x1"
338719|NCT01149616|O1|Outcome|Intervention|"Dexamethasone 8mg iv x 1~Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1"
338720|NCT01149616|E2|Reported Event|Placebo|"placebo~placebo: placebo administered 2 ml normal saline IV x1"
338721|NCT01149616|E1|Reported Event|Intervention|"Dexamethasone 8mg iv x 1~Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1"
338722|NCT01149538|B3|Baseline|Total|Total of all reporting groups
338723|NCT01149538|B2|Baseline|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
338724|NCT01149538|B1|Baseline|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
338725|NCT01149538|P2|Participant Flow|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
338726|NCT01149538|P1|Participant Flow|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
338727|NCT01149538|O2|Outcome|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
338728|NCT01149538|O1|Outcome|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
338729|NCT01149538|O2|Outcome|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
338730|NCT01149538|O1|Outcome|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
338731|NCT01149538|O2|Outcome|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
338732|NCT01149538|O1|Outcome|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
338733|NCT01149538|O2|Outcome|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
338734|NCT01149538|O1|Outcome|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
338735|NCT01149538|O2|Outcome|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
338736|NCT01149538|O1|Outcome|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
338737|NCT01149538|E2|Reported Event|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
338738|NCT01149538|E1|Reported Event|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
338739|NCT01149512|B1|Baseline|LAGB Patients in Weight Wise Program|All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.
338740|NCT01149512|P1|Participant Flow|LAGB Patients in Weight Wise Program|All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.
338741|NCT01149512|O1|Outcome|LAGB Patients in Weight Wise Program|All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.
338742|NCT01149512|O1|Outcome|LAGB Patients in Weight Wise Program|All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.
338743|NCT01149512|E1|Reported Event|LAGB Patients in Weight Wise Program|All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.
338744|NCT01149486|B3|Baseline|Total|Total of all reporting groups
338745|NCT01149486|B2|Baseline|Hyzaar® (Reference) First|100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in the second period.
338902|NCT01149421|E3|Reported Event|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338746|NCT01149486|B1|Baseline|Losartan/HCTZ (Test) First|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period.
338747|NCT01149486|P2|Participant Flow|Hyzaar® (Reference) First|100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in the second period.
338748|NCT01149486|P1|Participant Flow|Losartan/HCTZ (Test) First|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period.
338749|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
338750|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
338751|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
338752|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
338753|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
338754|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
338755|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
338756|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
338757|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
338758|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
338759|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
338760|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
338761|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
338762|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
338763|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
338764|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
338765|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
338766|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
338767|NCT01149486|E2|Reported Event|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
338768|NCT01149486|E1|Reported Event|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
338769|NCT01149473|B3|Baseline|Total|Total of all reporting groups
338770|NCT01149473|B2|Baseline|Hyzaar® (Reference) First|100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in the second period.
338771|NCT01149473|B1|Baseline|Losartan/HCTZ (Test) First|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period.
338772|NCT01149473|P2|Participant Flow|Hyzaar® (Reference) First|100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in the second period.
338773|NCT01149473|P1|Participant Flow|Losartan/HCTZ (Test) First|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period.
338774|NCT01149473|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
338775|NCT01149473|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
338776|NCT01149473|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
338777|NCT01149473|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
338778|NCT01149473|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
338779|NCT01149473|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
338780|NCT01149473|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
338781|NCT01149473|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
338782|NCT01149473|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
338783|NCT01149473|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
338784|NCT01149473|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
338785|NCT01149473|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
338786|NCT01149473|E2|Reported Event|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
338787|NCT01149473|E1|Reported Event|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
338788|NCT01149460|B3|Baseline|Total|Total of all reporting groups
338789|NCT01149460|B2|Baseline|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
338790|NCT01149460|B1|Baseline|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
338791|NCT01149460|P2|Participant Flow|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
352868|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
338792|NCT01149460|P1|Participant Flow|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
338793|NCT01149460|O2|Outcome|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
338794|NCT01149460|O1|Outcome|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
338795|NCT01149460|O2|Outcome|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
338796|NCT01149460|O1|Outcome|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
338797|NCT01149460|O2|Outcome|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
338798|NCT01149460|O1|Outcome|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
338799|NCT01149460|O2|Outcome|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
338800|NCT01149460|O1|Outcome|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
338801|NCT01149460|O2|Outcome|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
338802|NCT01149460|O1|Outcome|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
338803|NCT01149460|O2|Outcome|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
338804|NCT01149460|O1|Outcome|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
338805|NCT01149460|E2|Reported Event|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
338806|NCT01149460|E1|Reported Event|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
338807|NCT01149434|B3|Baseline|Total|Total of all reporting groups
338808|NCT01149434|B2|Baseline|Pharmacokinetic Arm-Phase II|"Patients going on the Pharmacodynamic study will receive JI-101 only.~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
338809|NCT01149434|B1|Baseline|Pharmacokinetic Arm - Phase 1|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.~Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus."
338810|NCT01149434|P2|Participant Flow|Pharmacodynamic Arm Phase 2|"Patients going on the Pharmacodynamic study will receive JI-101 only.~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
338811|NCT01149434|P1|Participant Flow|Pharmacokinetic Arm Phase 1|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.~Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
338812|NCT01149434|O1|Outcome|Pharmacodynamic Arm Phase 2|"Patients going on the Pharmacodynamic study will receive JI-101 only.~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
338813|NCT01149434|O1|Outcome|Pharmacodynamic Arm Phase 2|"Patients going on the Pharmacodynamic study will receive JI-101 only.~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
338814|NCT01149434|O1|Outcome|Pharmacodynamic Arm Phase 2|"Patients going on the Pharmacodynamic study will receive JI-101 only.~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
338815|NCT01149434|O1|Outcome|Pharmacokinetic Arm Phase 1|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.~Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
339828|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
338816|NCT01149434|O1|Outcome|Pharmacokinetic Arm Phase 1|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.~Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
338817|NCT01149434|O1|Outcome|Pharmacokinetic Arm Phase 1|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.~Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
338818|NCT01149434|O1|Outcome|Pharmacokinetic Arm|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.~Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
338819|NCT01149434|E2|Reported Event|Pharmacodynamic Arm|"Patients going on the Pharmacodynamic study will receive JI-101 only.~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
338820|NCT01149434|E1|Reported Event|Pharmacokinetic Arm|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.~Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
338821|NCT01149421|B4|Baseline|Total|Total of all reporting groups
338822|NCT01149421|B3|Baseline|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338823|NCT01149421|B2|Baseline|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338824|NCT01149421|B1|Baseline|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338825|NCT01149421|P3|Participant Flow|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338826|NCT01149421|P2|Participant Flow|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338827|NCT01149421|P1|Participant Flow|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338828|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338829|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338830|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338831|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338832|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338833|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338834|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338835|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338836|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338837|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338838|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338839|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338840|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338841|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338842|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338843|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338844|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338845|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338846|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338847|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338849|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338850|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338851|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338852|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338853|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338854|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338855|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338856|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338857|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338858|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338859|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338860|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338861|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338862|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338863|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338864|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338865|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338866|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338867|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338868|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338869|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338870|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338871|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338872|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338873|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338874|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338875|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338876|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338877|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338878|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338879|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338880|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338881|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338882|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338883|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338884|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338885|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338886|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338887|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338888|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338889|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338890|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338891|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338892|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338893|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338894|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338895|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338896|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338897|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338898|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338899|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
338900|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338901|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338903|NCT01149421|E2|Reported Event|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338904|NCT01149421|E1|Reported Event|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
338905|NCT01149148|B3|Baseline|Total|Total of all reporting groups
338906|NCT01149148|B2|Baseline|Standard of Care|Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
338907|NCT01149148|B1|Baseline|Intervention INVOS Cerebral Oximetry Monitoring|> 20% drop rSO2 from baseline or declines in rSO2 < 50%
338908|NCT01149148|P2|Participant Flow|Standard of Care|Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
338909|NCT01149148|P1|Participant Flow|Intervention INVOS Cerebral Oximetry Monitoring|> 20% drop rSO2 from baseline or declines in rSO2 < 50%
338910|NCT01149148|O2|Outcome|Standard of Care|Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
338911|NCT01149148|O1|Outcome|Intervention INVOS Cerebral Oximetry Monitoring|At the start of surgery two sensor pads will be placed on the patients forehead and attached to the INVOS Monitoring System. If the rSO2 values decrease >20% from baseline or decline below 50 the anesthesiologist will initiate an intervention: Increase mean arterial pressure, check head and cannula position, increase pump flow, increase systemic oxygenation, increase PaCo2 >45, increase anesthetic depth by increaseing volatile anesthetic or administering propoful boluses, consider PRBC transfusion for Hct<21%.
338912|NCT01149148|O2|Outcome|Standard of Care|Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
338913|NCT01149148|O1|Outcome|Intervention INVOS Cerebral Oximetry Monitoring|> 20% drop rSO2 from baseline or declines in rSO2 < 50%
338914|NCT01149148|E2|Reported Event|Standard of Care|Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
338915|NCT01149148|E1|Reported Event|Intervention INVOS Cerebral Oximetry Monitoring|> 20% drop rSO2 from baseline or declines in rSO2 < 50%
338916|NCT01149057|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
338917|NCT01149057|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilograms (mg/kg) intravenous (IV) infusion every 4 weeks for a period of 96 weeks.
338918|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
338919|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
338920|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
338921|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
338922|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
338923|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
338924|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
338925|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
338926|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
338927|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
338928|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
338929|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
338930|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
338931|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
338932|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
338933|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
338934|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
338935|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
338936|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
338937|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
338938|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
338939|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
338940|NCT01149057|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
338941|NCT01148979|B3|Baseline|Total|Total of all reporting groups
338942|NCT01148979|B2|Baseline|Vyvanse, Then Placebo|"Participants first received Lisdexamfetamine Dimesylate 20-50 mg capsule each morning for 4 weeks. After a washout period of 2 weeks, they then received Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) capsule) each morning for 4 weeks.~Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.~Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
338943|NCT01148979|B1|Baseline|Placebo, Then Vyvanse|"Participants first received Placebo capsule (matching Lisdexamfetamine Dimesylate(Vyvanse) 20-50 mg capsule) each morning for 4 weeks. After a washout period of 2 weeks, they then received Lisdexamfetamine Dimesylate capsule each morning for 4 weeks.~Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.~Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
338944|NCT01148979|P2|Participant Flow|Vyvanse, Then Placebo|"Participants first received Lisdexamfetamine Dimesylate (Vyvanse) 20-50 mg capsule each morning for 4 weeks, staring with initial dose 30 mg/d. After a washout period of 2 weeks, they then received Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) capsule) each morning for 4 weeks.~Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.~Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
338945|NCT01148979|P1|Participant Flow|Placebo, Then Vyvanse|"Participants first received Placebo capsule (matching Lisdexamfetamine Dimesylate(Vyvanse) 20-50 mg capsule) each morning for 4 weeks. After a washout period of 2 weeks, they then received Lisdexamfetamine Dimesylate (Vyvanse) capsule each morning for 4 weeks, starting with initial dose 30 mg/d.~Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.~Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
338946|NCT01148979|O2|Outcome|Lisdexamfetamine Dimesylate (Vyvanse)|"Participants first received Lisdexamfetamine Dimesylate (Vyvanse) 20-50 mg capsule each morning for 4 weeks, staring with initial dose 30 mg/d. After a washout period of 2 weeks, they then received Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) capsule) each morning for 4 weeks.~Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.~Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
338947|NCT01148979|O1|Outcome|Placebo Adjunct|"Participants first received Placebo capsule (matching Lisdexamfetamine Dimesylate(Vyvanse) 20-50 mg capsule) each morning for 4 weeks. After a washout period of 2 weeks, they then received Lisdexamfetamine Dimesylate (Vyvanse) capsule each morning for 4 weeks, starting with initial dose 30 mg/d.~Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.~Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
338948|NCT01148979|E2|Reported Event|Adjunct Placebo|"Participants receive Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) 20-50 mg capsule) each morning for 4 weeks. After a washout period of 2 weeks, they receive Lisdexamfetamine Dimesylate capsule each morning for 4 weeks.~Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
338949|NCT01148979|E1|Reported Event|Adjunct Lisdexamfetamine (Vyvanse)|"Participants receive Lisdexamfetamine Dimesylate 20-50 mg capsule each morning for 4 weeks. After a washout period of 2 weeks, they receive Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) capsule) each morning for 4 weeks.~Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg."
338950|NCT01148862|B1|Baseline|Entire Study Population|Includes groups randomized to LGS on first and LGS off first
338951|NCT01148862|P2|Participant Flow|LGS Off First, Then LGS on|LGS off first, then LGS on group will wear the MiniMed Paradigm® X54 System with Low Glucose Suspend (LGS) turned 'OFF' first, then LGS turned on 'ON' after crossing over
338952|NCT01148862|P1|Participant Flow|LGS on First, Then LGS Off|LGS on first, then LGS off group will wear the MiniMed Paradigm® X54 System with the Low Glucose Suspend (LGS) feature turned 'ON' first, then LGS turned 'OFF' after crossing over
338953|NCT01148862|O2|Outcome|LGS Off: Without Low Glucose Suspend (LGS) Feature|LGS off: Without Low Glucose Suspend (LGS) feature
338954|NCT01148862|O1|Outcome|LGS on: Low Glucose Suspend (LGS) Feature Turned 'ON'|LGS on: Low Glucose Suspend (LGS) feature turned 'ON'
338955|NCT01148862|O2|Outcome|LGS Off: Without Low Glucose Suspend (LGS) Feature|LGS off: Without Low Glucose Suspend (LGS) feature
338956|NCT01148862|O1|Outcome|LGS on: Low Glucose Suspend (LGS) Feature Turned 'ON'|LGS on: Low Glucose Suspend (LGS) feature turned 'ON'
338957|NCT01148862|E2|Reported Event|LGS on: Low Glucose Suspend (LGS) Feature Turned 'ON'|
338958|NCT01148862|E1|Reported Event|LGS Off: Without Low Glucose Suspend (LGS) Feature|
338959|NCT01148836|B3|Baseline|Total|Total of all reporting groups
338960|NCT01148836|B2|Baseline|Pulmonary Hypertension Subjects|
338961|NCT01148836|B1|Baseline|Healthy Controls Subjects|
338962|NCT01148836|P2|Participant Flow|Pulmonary Hypertension Subjects (Disease)|
338963|NCT01148836|P1|Participant Flow|Healthy Controls|
338964|NCT01148836|O2|Outcome|Normal Controls|Normal controls taking Co-Q for three months
338965|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
338966|NCT01148836|O2|Outcome|Normal Controls|Normal controls taking Co-Q for three months
338967|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
338968|NCT01148836|O2|Outcome|Normal Controls|Normal controls taking Co-Q for three months
338969|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
338970|NCT01148836|O2|Outcome|Normal Controls|Normal controls taking Co-Q for three months
338971|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
338972|NCT01148836|O2|Outcome|Normal Controls|Normal controls taking Co-Q for three months
338973|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
338974|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
338975|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
338976|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
338977|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
338978|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
338979|NCT01148836|E2|Reported Event|Coenzyme Q and Healthy Controls|Healthy Control subjects Nutritional Supplement Coenzyme Q-10: Nutritional Supplement
338980|NCT01148836|E1|Reported Event|Coenzyme Q and Pulmonary Hypertension|Pulmonary Hypertension subjects Nutritional Supplement Coenzyme Q-10: Nutritional Supplement
338981|NCT01148771|B3|Baseline|Total|Total of all reporting groups
338982|NCT01148771|B2|Baseline|Ertapenem IV 30 Minute Infusion First, Then 5 Minute Bolus|Participants received ertapenem 1 gram as a 30 minute infusion every 24 hours for 3 doses. After a 4 day washout, participants crossed over to receive ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses.
338983|NCT01148771|B1|Baseline|Ertapenem IV 5 Minute Bolus First, Then 30 Minute Infusion|Participants received ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses. After a 4 day washout, participants were crossed over to receive ertapenem 1 gram as a 30 minute IV infusion every 24 hours for 3 doses.
338984|NCT01148771|P2|Participant Flow|Ertapenem IV 30 Minute Infusion First, Then 5 Minute Bolus|Participants received ertapenem 1 gram as a 30 minute infusion every 24 hours for 3 doses. After a 4 day washout, participants crossed over to receive ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses.
338985|NCT01148771|P1|Participant Flow|Ertapenem IV 5 Minute Bolus First, Then 30 Minute Infusion|Participants received ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses. After a 4 day washout, participants were crossed over to receive ertapenem 1 gram as a 30 minute IV infusion every 24 hours for 3 doses.
338986|NCT01148771|O2|Outcome|Ertapenem 1 Gram IV 30 Minute Infusion|Participants received ertapenem 1 gram as a 30 minute infusion every 24 hours for 3 doses.
338987|NCT01148771|O1|Outcome|Ertapenem 1 Gram IV 5 Minute Bolus|Participants received ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses.
338988|NCT01148771|O2|Outcome|Ertapenem 1 Gram IV 30 Minute Infusion|This is a simulated population of 5000 patients receiving ertapenem 1 gram every 24 hours as a 30 minute IV infusion.
338989|NCT01148771|O1|Outcome|Ertapenem 1 Gram IV 5 Minute Bolus|This is a simulated population of 5000 patients receiving ertapenem 1 gram every 24 hours as a 5 minute IV bolus.
338990|NCT01148771|O2|Outcome|Ertapenem IV 30 Minute Infusion|
338991|NCT01148771|O1|Outcome|Ertapenem IV 5 Minute Bolus|
338992|NCT01148771|O2|Outcome|Ertapenem 1 Gram IV 30 Minute Infusion|Participants received ertapenem 1 gram as a 30 minute infusion every 24 hours for 3 doses.
338993|NCT01148771|O1|Outcome|Ertapenem 1 Gram IV 5 Minute Bolus|Participants received ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses.
338994|NCT01148771|E2|Reported Event|Ertapenem IV 30 Minute Infusion First, Then 5 Minute Bolus|Participants received ertapenem 1 gram as a 30 minute infusion every 24 hours for 3 doses. After a 4 day washout, participants crossed over to receive ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses.
338995|NCT01148771|E1|Reported Event|Ertapenem IV 5 Minute Bolus First, Then 30 Minute Infusion|Participants received ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses. After a 4 day washout, participants were crossed over to receive ertapenem 1 gram as a 30 minute IV infusion every 24 hours for 3 doses.
338996|NCT01148745|B1|Baseline|Ferumoxytol|2 doses of 510 mg IV over 17 seconds separated by 3 days
338997|NCT01148745|P1|Participant Flow|Ferumoxytol|2 doses of 510 mg IV over 17 seconds separated by 3 days
338998|NCT01148745|O1|Outcome|Ferumoxytol|2 doses of 510 mg IV over 17 seconds separated by 3 days
338999|NCT01148745|O1|Outcome|Ferumoxytol 510 mg|2 doses of 510 mg IV over 17 seconds separated by 3 days
339000|NCT01148745|O1|Outcome|Ferumoxytol|All participants received 510 mg IV ferumoxytol at both visits 1 and 2.
339001|NCT01148745|E1|Reported Event|Ferumoxytol|2 doses of 510 mg IV over 17 seconds separated by 3 days
339002|NCT01148693|B3|Baseline|Total|Total of all reporting groups
339003|NCT01148693|B2|Baseline|Placebo|participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
339004|NCT01148693|B1|Baseline|Gentamicin|participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
339005|NCT01148693|P2|Participant Flow|Placebo|participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
339006|NCT01148693|P1|Participant Flow|Gentamicin|participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
339007|NCT01148693|O2|Outcome|Placebo|patients for whom distilled water is added to contrast during ERCP
339008|NCT01148693|O1|Outcome|Gentamicin|patients for whom 10m/10cc of gentamicin is added to contrast during ERCP
339009|NCT01148693|E2|Reported Event|Placebo|participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
339010|NCT01148693|E1|Reported Event|Gentamicin|participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
339011|NCT01148563|B3|Baseline|Total|Total of all reporting groups
339012|NCT01148563|B2|Baseline|Tele-health Monitoring Group|The tele-monitoring intervention group will have the continual standard care from their physician plus the tele-health monitoring. The tele-health monitor will collect the following data: weight, blood pressure, pulse oximetry, pulse rate, & patient responses to disease-specific questions regarding changes in state of health for 6 months.
339013|NCT01148563|B1|Baseline|Standard Care|The Standard Care group will continue regular LSU HCSD disease management care for heart failure patients with no additional intervention.
339014|NCT01148563|P2|Participant Flow|Tele-health Monitoring Group|The tele-monitoring intervention group will have the continual standard care from their physician plus the tele-health monitoring. The tele-health monitor will collect the following data: weight, blood pressure, pulse oximetry, pulse rate, & patient responses to disease-specific questions regarding changes in state of health for 6 months.
339015|NCT01148563|P1|Participant Flow|Standard Care|The Standard Care group will continue regular LSU HCSD disease management care for heart failure patients with no additional intervention.
339016|NCT01148563|O2|Outcome|Tele-health Monitoring Group|"The tele-monitoring intervention group will have the continual standard care from their physician plus the tele-health monitoring. The tele-health monitor will collect the following data: weight, blood pressure, pulse oximetry, pulse rate, & patient responses to disease-specific questions regarding changes in state of health for 6 months.~Tele-health Monitoring: Daily tele-health monitoring data will be collected from randomized participants."
339017|NCT01148563|O1|Outcome|Standard Care|The Standard Care group will continue regular LSU HCSD disease management care for heart failure patients with no additional intervention.
339018|NCT01148563|O2|Outcome|Tele-health Monitoring Group|The tele-monitoring intervention group will have the continual standard care from their physician plus the tele-health monitoring. The tele-health monitor will collect the following data: weight, blood pressure, pulse oximetry, pulse rate, & patient responses to disease-specific questions regarding changes in state of health for 6 months.
339019|NCT01148563|O1|Outcome|Standard Care|The Standard Care group will continue regular LSU HCSD disease management care for heart failure patients with no additional intervention.
339020|NCT01148563|E2|Reported Event|Tele-health Monitoring Group|The tele-monitoring intervention group will have the continual standard care from their physician plus the tele-health monitoring. The tele-health monitor will collect the following data: weight, blood pressure, pulse oximetry, pulse rate, & patient responses to disease-specific questions regarding changes in state of health for 6 months.
339021|NCT01148563|E1|Reported Event|Standard Care|The Standard Care group will continue regular LSU HCSD disease management care for heart failure patients with no additional intervention.
339022|NCT01148537|B4|Baseline|Total|Total of all reporting groups
339023|NCT01148537|B3|Baseline|Moxifloxacin|Positive control: One 400 mg moxifloxacin tablet (Avelox®) by mouth on days 6 and 13
339024|NCT01148537|B2|Baseline|Placebo|Matching placebo transdermal patches.
339025|NCT01148537|B1|Baseline|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
339026|NCT01148537|P3|Participant Flow|Moxifloxacin|Positive control: One 400 mg moxifloxacin tablet (Avelox®) by mouth on days 6 and 13
339027|NCT01148537|P2|Participant Flow|Placebo|Matching placebo transdermal patches.
339028|NCT01148537|P1|Participant Flow|BTDS|"Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h. Randomization was from predose on day 1 to predose on day 14. There were 3 treatment groups: BTDS, placebo, and moxifloxacin as the positive control. The treatment groups between placebo and BTDS were double-blinded. Moxifloxacin treatment was open label to subjects, to the investigator, and the staff at the study site.~BTDS or placebo TDS was applied on day 1 for 3 days (BTDS 5), on day 4 for 3 days (BTDS 10), on day 7 for 3 days (BTDS 20), and on day 10 for 4 days (2 * BTDS 20). On day 6 and day 13, subjects in the positive control group received one 400 mg tablet of moxifloxacin."
339029|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
339030|NCT01148537|O1|Outcome|Moxifloxacin|Positive Control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13.
339031|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
339032|NCT01148537|O1|Outcome|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
339033|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
339034|NCT01148537|O1|Outcome|Mofloxacin|Positive Control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13.
339035|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
339036|NCT01148537|O1|Outcome|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
339037|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
339038|NCT01148537|O1|Outcome|Moxifloxacin|Positive Control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13.
339039|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
339040|NCT01148537|O1|Outcome|Moxifloxacin|Positive Control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13.
339041|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
339042|NCT01148537|O1|Outcome|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
339043|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
339044|NCT01148537|O1|Outcome|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
339045|NCT01148537|E3|Reported Event|Moxifloxacin|Positive control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13.
339046|NCT01148537|E2|Reported Event|Placebo|Matching placebo transdermal patches.
339047|NCT01148537|E1|Reported Event|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
339048|NCT01148524|B10|Baseline|Total|Total of all reporting groups
339049|NCT01148524|B9|Baseline|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
339050|NCT01148524|B8|Baseline|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
339051|NCT01148524|B7|Baseline|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
339052|NCT01148524|B6|Baseline|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
339053|NCT01148524|B5|Baseline|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
339054|NCT01148524|B4|Baseline|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
339055|NCT01148524|B3|Baseline|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
339056|NCT01148524|B2|Baseline|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
339057|NCT01148524|B1|Baseline|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
339058|NCT01148524|P9|Participant Flow|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
339059|NCT01148524|P8|Participant Flow|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
339060|NCT01148524|P7|Participant Flow|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
339061|NCT01148524|P6|Participant Flow|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
339062|NCT01148524|P5|Participant Flow|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
339063|NCT01148524|P4|Participant Flow|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
339064|NCT01148524|P3|Participant Flow|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
339065|NCT01148524|P2|Participant Flow|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
352869|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
339066|NCT01148524|P1|Participant Flow|rMenB06|Subjects who had received 2 doses each of Recombinant Meningococcal B Vaccine with Outer Membrane Vesicle from the New Zealand Strain (rMenB+OMV-NZ) (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
339067|NCT01148524|O9|Outcome|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
339068|NCT01148524|O8|Outcome|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
339069|NCT01148524|O7|Outcome|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
339070|NCT01148524|O6|Outcome|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
339071|NCT01148524|O5|Outcome|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
339072|NCT01148524|O4|Outcome|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
339073|NCT01148524|O3|Outcome|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
339074|NCT01148524|O2|Outcome|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
339075|NCT01148524|O1|Outcome|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
339076|NCT01148524|O8|Outcome|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
339077|NCT01148524|O7|Outcome|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
339078|NCT01148524|O6|Outcome|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
339079|NCT01148524|O5|Outcome|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
339080|NCT01148524|O4|Outcome|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
339081|NCT01148524|O3|Outcome|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
339082|NCT01148524|O2|Outcome|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
339083|NCT01148524|O1|Outcome|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
339084|NCT01148524|O9|Outcome|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
339085|NCT01148524|O8|Outcome|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
339086|NCT01148524|O7|Outcome|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
339087|NCT01148524|O6|Outcome|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
339088|NCT01148524|O5|Outcome|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
339089|NCT01148524|O4|Outcome|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
339090|NCT01148524|O3|Outcome|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
339091|NCT01148524|O2|Outcome|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
339092|NCT01148524|O1|Outcome|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
339093|NCT01148524|O9|Outcome|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
339094|NCT01148524|O8|Outcome|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
339095|NCT01148524|O7|Outcome|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
339096|NCT01148524|O6|Outcome|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
339097|NCT01148524|O5|Outcome|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
339098|NCT01148524|O4|Outcome|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
339099|NCT01148524|O3|Outcome|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
339100|NCT01148524|O2|Outcome|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
339101|NCT01148524|O1|Outcome|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
339102|NCT01148524|E9|Reported Event|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
339103|NCT01148524|E8|Reported Event|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
339104|NCT01148524|E7|Reported Event|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
339105|NCT01148524|E6|Reported Event|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
339106|NCT01148524|E5|Reported Event|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
339107|NCT01148524|E4|Reported Event|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
339108|NCT01148524|E3|Reported Event|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
339109|NCT01148524|E2|Reported Event|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
339110|NCT01148524|E1|Reported Event|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
339111|NCT01148511|B3|Baseline|Total|Total of all reporting groups
339112|NCT01148511|B2|Baseline|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
339113|NCT01148511|B1|Baseline|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
339114|NCT01148511|P3|Participant Flow|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
339115|NCT01148511|P2|Participant Flow|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
339116|NCT01148511|P1|Participant Flow|All Patients|All 99 patients were exposed to study drug. 93 of the 99 patients were randomized into the Treat and Extend and the Treat and Observe treatment groups.
339117|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
339118|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
339119|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
339120|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
339121|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
339122|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
339123|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
339124|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
339125|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
339126|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
339127|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
339159|NCT01148017|O3|Outcome|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
339690|NCT01147497|O2|Outcome|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
339128|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
339129|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
339130|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
339131|NCT01148511|E3|Reported Event|Before Randomization|These 6 patients were exposed to study drug but discontinued from the study prior to randomization.
339132|NCT01148511|E2|Reported Event|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
339133|NCT01148511|E1|Reported Event|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
339134|NCT01148420|B1|Baseline|DMPA + MPA|
339135|NCT01148420|P1|Participant Flow|DMPA + MPA|150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days.
339136|NCT01148420|O1|Outcome|DMPA + MPA|
339137|NCT01148420|O1|Outcome|DMPA + MPA|150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days.
339138|NCT01148420|O1|Outcome|DMPA + MPA|150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days.
339139|NCT01148420|E1|Reported Event|DMPA & High Dose MPA|DMPA & High Dose MPA
339140|NCT01148056|B1|Baseline|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
339141|NCT01148056|P1|Participant Flow|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
339142|NCT01148056|O1|Outcome|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
339143|NCT01148056|O1|Outcome|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
339144|NCT01148056|O1|Outcome|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
339145|NCT01148056|O1|Outcome|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
339146|NCT01148056|O1|Outcome|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
339147|NCT01148056|O1|Outcome|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
339148|NCT01148056|E1|Reported Event|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
339149|NCT01148017|B5|Baseline|Total|Total of all reporting groups
339150|NCT01148017|B4|Baseline|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
339151|NCT01148017|B3|Baseline|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
339152|NCT01148017|B2|Baseline|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
339153|NCT01148017|B1|Baseline|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
339154|NCT01148017|P4|Participant Flow|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
339155|NCT01148017|P3|Participant Flow|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
339156|NCT01148017|P2|Participant Flow|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
339157|NCT01148017|P1|Participant Flow|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
339158|NCT01148017|O4|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
339193|NCT01147926|B3|Baseline|Total|Total of all reporting groups
339160|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
339161|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
339162|NCT01148017|O3|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
339163|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
339164|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
339165|NCT01148017|O3|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
339166|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
339167|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
339168|NCT01148017|O3|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
339169|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
339170|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
339171|NCT01148017|O3|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
339172|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
339173|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
339174|NCT01148017|O3|Outcome|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
339175|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
339176|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
339177|NCT01148017|O3|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
339178|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
339179|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
339180|NCT01148017|O3|Outcome|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
339181|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
339182|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
339183|NCT01148017|O3|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
339184|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
339185|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
339186|NCT01148017|O3|Outcome|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
339187|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
339188|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
339189|NCT01148017|E4|Reported Event|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
339190|NCT01148017|E3|Reported Event|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
339191|NCT01148017|E2|Reported Event|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
339192|NCT01148017|E1|Reported Event|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
339194|NCT01147926|B2|Baseline|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
339195|NCT01147926|B1|Baseline|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
339196|NCT01147926|P2|Participant Flow|PRUCALOPRIDE|Prucalopride 2 milligram (mg) tablet orally once daily for subjects greater than or equal to (≥) 18 to less than (<) 65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
339197|NCT01147926|P1|Participant Flow|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
339198|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
339199|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
339200|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
339201|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
339202|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
339203|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
339204|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
339205|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
339206|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
339207|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
339208|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
339209|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
339210|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
339211|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
339212|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
339213|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
339214|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
339215|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
339216|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
339217|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
339218|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
339219|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
339220|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
339221|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
339222|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
339223|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
339224|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
339225|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
339226|NCT01147926|E2|Reported Event|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to less than <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
339227|NCT01147926|E1|Reported Event|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
339228|NCT01147900|B4|Baseline|Total|Total of all reporting groups
339229|NCT01147900|B3|Baseline|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339691|NCT01147497|O1|Outcome|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
339230|NCT01147900|B2|Baseline|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339231|NCT01147900|B1|Baseline|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339232|NCT01147900|P3|Participant Flow|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339233|NCT01147900|P2|Participant Flow|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339234|NCT01147900|P1|Participant Flow|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339235|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339236|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339237|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339238|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339239|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339240|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339241|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339242|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339243|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339244|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339245|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339246|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339247|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339248|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339249|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339250|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339251|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
352870|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
339252|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339253|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339254|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339255|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339256|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339257|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339258|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339259|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339260|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339261|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339262|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339263|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339264|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339265|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339266|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339267|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339268|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339269|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339270|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339271|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339272|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339273|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339274|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339275|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339276|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339277|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339278|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339279|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339280|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339281|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339282|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339283|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339284|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
352871|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
339285|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339286|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339287|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339288|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339289|NCT01147900|E3|Reported Event|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339290|NCT01147900|E2|Reported Event|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339291|NCT01147900|E1|Reported Event|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
339292|NCT01147874|B1|Baseline|All Participants|Participants with psoriasis were observed for 8 weeks.
339293|NCT01147874|P1|Participant Flow|All Participants|Participants with psoriasis were observed for 8 weeks.
339294|NCT01147874|O1|Outcome|All Participants|Participants with psoriasis were observed for 8 weeks.
339295|NCT01147874|O1|Outcome|All Participants|Participants with psoriasis were observed for 8 weeks.
339296|NCT01147874|O1|Outcome|All Participants|Participants with psoriasis were observed for 8 weeks.
339297|NCT01147874|E1|Reported Event|All Participants|Participants with psoriasis were observed for 8 weeks.
339298|NCT01147848|B3|Baseline|Total|Total of all reporting groups
339299|NCT01147848|B2|Baseline|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
339300|NCT01147848|B1|Baseline|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
339301|NCT01147848|P3|Participant Flow|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
339302|NCT01147848|P2|Participant Flow|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
339303|NCT01147848|P1|Participant Flow|Fluticasone Propionate 250 µg BID|Participants received Fluticasone Propionate 250 micrograms (µg) twice a day (BID) and salbutamol/albuterol as required to control symptoms.
339304|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
339607|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
339305|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
339306|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
339307|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
339308|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
339309|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
339310|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
339311|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
339312|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
339313|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
339314|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
339315|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
339316|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
339317|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
339318|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
339319|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
339320|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
339321|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
339322|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
339323|NCT01147848|O1|Outcome|FFluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
339324|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
339325|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
339326|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
339327|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
339328|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
339329|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
339330|NCT01147848|E2|Reported Event|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
339331|NCT01147848|E1|Reported Event|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
339332|NCT01147822|B3|Baseline|Total|Total of all reporting groups
339333|NCT01147822|B2|Baseline|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
339334|NCT01147822|B1|Baseline|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
339335|NCT01147822|P2|Participant Flow|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
339336|NCT01147822|P1|Participant Flow|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
339337|NCT01147822|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
339338|NCT01147822|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
339339|NCT01147822|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
339340|NCT01147822|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
339341|NCT01147822|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
339342|NCT01147822|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
339343|NCT01147822|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
339344|NCT01147822|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
339345|NCT01147822|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
339346|NCT01147822|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
339347|NCT01147822|E2|Reported Event|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
339348|NCT01147822|E1|Reported Event|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
339349|NCT01147809|B7|Baseline|Total|Total of all reporting groups
339350|NCT01147809|B6|Baseline|Phase II: Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339351|NCT01147809|B5|Baseline|Phase II: Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339608|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
339352|NCT01147809|B4|Baseline|Phase I: 28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339353|NCT01147809|B3|Baseline|Phase I: 28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339354|NCT01147809|B2|Baseline|Phase I: 21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339355|NCT01147809|B1|Baseline|Phase I: 21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339356|NCT01147809|P6|Participant Flow|Phase II: Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of the 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339357|NCT01147809|P5|Participant Flow|Phase II: Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of the 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339358|NCT01147809|P4|Participant Flow|Phase I: 28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of the 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339359|NCT01147809|P3|Participant Flow|Phase I: 28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of the 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339360|NCT01147809|P2|Participant Flow|Phase I: 21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339361|NCT01147809|P1|Participant Flow|Phase I: 21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339362|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339363|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339364|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339365|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339366|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339367|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339368|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339369|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339370|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339371|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339372|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339373|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339374|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339375|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339376|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339377|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339378|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339379|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339380|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339381|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339382|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339383|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339384|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339385|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339386|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339387|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339388|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339389|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339390|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339391|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339392|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339393|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
352872|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
339394|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339395|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339396|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339397|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339398|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339399|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339400|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339401|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339402|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339403|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339404|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339405|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339406|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339407|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339408|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339409|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339410|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339411|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339412|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339413|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339414|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339415|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339416|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339417|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339418|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339419|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339420|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339421|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339422|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339423|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339424|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339425|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339426|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339427|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339428|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg)|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339429|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339430|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339431|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339432|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339433|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339434|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339435|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339436|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339481|NCT01147744|B1|Baseline|Placebo|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339437|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339438|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339439|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339440|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339441|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339442|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339443|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339444|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339445|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339446|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339447|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339448|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339449|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339450|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339451|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339452|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339453|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339454|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339455|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339456|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339457|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339458|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339459|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339460|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339461|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339462|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339463|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339464|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339465|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339466|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339467|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339468|NCT01147809|E6|Reported Event|Phase II: Eltrombopag|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339469|NCT01147809|E5|Reported Event|Phase II: Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
339470|NCT01147809|E4|Reported Event|Phase I: 28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339471|NCT01147809|E3|Reported Event|Phase I: 28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339472|NCT01147809|E2|Reported Event|Phase I: 21-Day Cycle Eltrombopag|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339473|NCT01147809|E1|Reported Event|Phase I: 21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
339474|NCT01147744|B8|Baseline|Total|Total of all reporting groups
339475|NCT01147744|B7|Baseline|Montelukast 10 mg|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
339476|NCT01147744|B6|Baseline|Fluticasone Propionate 100 mcg|Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339477|NCT01147744|B5|Baseline|GSK2190915 300 mg|Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339478|NCT01147744|B4|Baseline|GSK2190915 100 mg|Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339479|NCT01147744|B3|Baseline|GSK2190915 30 mg|Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339480|NCT01147744|B2|Baseline|GSK2190915 10 mg|Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339606|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
339482|NCT01147744|P7|Participant Flow|Montelukast 10mg|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
339483|NCT01147744|P6|Participant Flow|Fluticasone Propionate 100 Microgram (mcg)|Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339484|NCT01147744|P5|Participant Flow|GSK2190915 300mg|Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339485|NCT01147744|P4|Participant Flow|GSK2190915 100mg|Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339486|NCT01147744|P3|Participant Flow|GSK2190915 30mg|Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339487|NCT01147744|P2|Participant Flow|GSK2190915 10 Milligrams (mg)|Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339488|NCT01147744|P1|Participant Flow|Placebo|Participants received two tablets of placebo orally plus one dose of fluticasone propionate (FP) matching placebo twice daily (BID) via dry powder inhaler (DPI) in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally once daily (QD) in evening for the 8-Weeks.
339489|NCT01147744|O7|Outcome|Montelukast 10mg|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
339490|NCT01147744|O6|Outcome|Fluticasone Propionate 100 mcg|Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339491|NCT01147744|O5|Outcome|GSK2190915 300mg|Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339492|NCT01147744|O4|Outcome|GSK2190915 100mg|Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339493|NCT01147744|O3|Outcome|GSK2190915 30mg|Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339494|NCT01147744|O2|Outcome|GSK2190915 10mg|Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339495|NCT01147744|O1|Outcome|Placebo|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339496|NCT01147744|O7|Outcome|Montelukast 10 mg|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
339497|NCT01147744|O6|Outcome|Fluticasone Propionate 100 mcg|Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339498|NCT01147744|O5|Outcome|GSK2190915 300 mg|Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339499|NCT01147744|O4|Outcome|GSK2190915 10 0mg|Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339500|NCT01147744|O3|Outcome|GSK2190915 30 mg|Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339501|NCT01147744|O2|Outcome|GSK2190915 10 mg|Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339502|NCT01147744|O1|Outcome|Placebo|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339503|NCT01147744|O7|Outcome|Montelukast 10mg|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
339504|NCT01147744|O6|Outcome|Fluticasone Propionate 100 mcg|Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339505|NCT01147744|O5|Outcome|GSK2190915 300mg|Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339506|NCT01147744|O4|Outcome|GSK2190915 100mg|Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339507|NCT01147744|O3|Outcome|GSK2190915 30mg|Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339508|NCT01147744|O2|Outcome|GSK2190915 10mg|Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339509|NCT01147744|O1|Outcome|Placebo|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339510|NCT01147744|O7|Outcome|Montelukast 10mg|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
339511|NCT01147744|O6|Outcome|Fluticasone Propionate 100 mcg|Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339512|NCT01147744|O5|Outcome|GSK2190915 300mg|Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339513|NCT01147744|O4|Outcome|GSK2190915 100mg|Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339514|NCT01147744|O3|Outcome|GSK2190915 30mg|Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339515|NCT01147744|O2|Outcome|GSK2190915 10mg|Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339516|NCT01147744|O1|Outcome|Placebo|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339517|NCT01147744|O7|Outcome|Montelukast 10mg|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
339518|NCT01147744|O6|Outcome|Fluticasone Propionate 100 mcg|Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339519|NCT01147744|O5|Outcome|GSK2190915 300mg|Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339520|NCT01147744|O4|Outcome|GSK2190915 100mg|Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339521|NCT01147744|O3|Outcome|GSK2190915 30mg|Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339522|NCT01147744|O2|Outcome|GSK2190915 10mg|Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339523|NCT01147744|O1|Outcome|Placebo|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339524|NCT01147744|O7|Outcome|Montelukast 10 mg|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
339525|NCT01147744|O6|Outcome|Fluticasone Propionate 100 mcg|Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339526|NCT01147744|O5|Outcome|GSK2190915 300 mg|Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339527|NCT01147744|O4|Outcome|GSK2190915 100 mg|Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339528|NCT01147744|O3|Outcome|GSK2190915 30 mg|Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339529|NCT01147744|O2|Outcome|GSK2190915 10 mg|Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339530|NCT01147744|O1|Outcome|Placebo|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339531|NCT01147744|O7|Outcome|Montelukast 10 mg|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
339532|NCT01147744|O6|Outcome|Fluticasone Propionate 100 mcg|Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339533|NCT01147744|O5|Outcome|GSK2190915 300 mg|Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339534|NCT01147744|O4|Outcome|GSK2190915 100 mg|Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339535|NCT01147744|O3|Outcome|GSK2190915 30 mg|Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339536|NCT01147744|O2|Outcome|GSK2190915 10 mg|Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339537|NCT01147744|O1|Outcome|Placebo|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339538|NCT01147744|O7|Outcome|Montelukast 10 mg|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
339539|NCT01147744|O6|Outcome|Fluticasone Propionate 100 mcg|Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339540|NCT01147744|O5|Outcome|GSK2190915 300 mg|Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339541|NCT01147744|O4|Outcome|GSK2190915 100 mg|Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339542|NCT01147744|O3|Outcome|GSK2190915 30 mg|Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339543|NCT01147744|O2|Outcome|GSK2190915 10 mg|Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339544|NCT01147744|O1|Outcome|Placebo|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339545|NCT01147744|O7|Outcome|Montelukast 10 mg|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
339546|NCT01147744|O6|Outcome|Fluticasone Propionate 100 mcg|Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339547|NCT01147744|O5|Outcome|GSK2190915 300 mg|Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339548|NCT01147744|O4|Outcome|GSK2190915 100 mg|Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339549|NCT01147744|O3|Outcome|GSK2190915 30 mg|Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339550|NCT01147744|O2|Outcome|GSK2190915 10 mg|Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339551|NCT01147744|O1|Outcome|Placebo|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339552|NCT01147744|O7|Outcome|Montelukast 10 mg|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
339553|NCT01147744|O6|Outcome|Fluticasone Propionate 100 mcg|Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339554|NCT01147744|O5|Outcome|GSK2190915 300 mg|Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339555|NCT01147744|O4|Outcome|GSK2190915 100 mg|Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339556|NCT01147744|O3|Outcome|GSK2190915 30 mg|Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339557|NCT01147744|O2|Outcome|GSK2190915 10 mg|Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339558|NCT01147744|O1|Outcome|Placebo|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339559|NCT01147744|O7|Outcome|Montelukast 10 mg|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
339560|NCT01147744|O6|Outcome|Fluticasone Propionate 100 mcg|Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339561|NCT01147744|O5|Outcome|GSK2190915 300 mg|Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339562|NCT01147744|O4|Outcome|GSK2190915 100 mg|Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339563|NCT01147744|O3|Outcome|GSK2190915 30 mg|Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339564|NCT01147744|O2|Outcome|GSK2190915 10 mg|Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339565|NCT01147744|O1|Outcome|Placebo|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339566|NCT01147744|O7|Outcome|Montelukast 10 mg|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
339567|NCT01147744|O6|Outcome|Fluticasone Propionate 100 mcg|Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339568|NCT01147744|O5|Outcome|GSK2190915 300 mg|Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339569|NCT01147744|O4|Outcome|GSK2190915 100 mg|Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339570|NCT01147744|O3|Outcome|GSK2190915 30 mg|Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339571|NCT01147744|O2|Outcome|GSK2190915 10 mg|Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339572|NCT01147744|O1|Outcome|Placebo|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339573|NCT01147744|E7|Reported Event|Montelukast 10mg|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
339688|NCT01147497|O2|Outcome|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
339574|NCT01147744|E6|Reported Event|Fluticasone Propionate 100 mcg|Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339575|NCT01147744|E5|Reported Event|GSK2190915 300mg|Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339576|NCT01147744|E4|Reported Event|GSK2190915 100mg|Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339577|NCT01147744|E3|Reported Event|GSK2190915 30mg|Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339578|NCT01147744|E2|Reported Event|GSK2190915 10mg|Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339579|NCT01147744|E1|Reported Event|Placebo|Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
339580|NCT01147653|B3|Baseline|Total|Total of all reporting groups
339581|NCT01147653|B2|Baseline|Placebo First, Then Autologous UCB Reinfusion|Subjects receive Placebo at Baseline, then autologous umbilical cord blood at Year 1.
339582|NCT01147653|B1|Baseline|Autologous UCB First, Then Placebo|Subjects receive autologous umbilical cord blood at Baseline, then Placebo at Year 1.
339583|NCT01147653|P2|Participant Flow|Placebo First, Then Autologous UCB Reinfusion|Subjects receive Placebo at Baseline, then autologous umbilical cord blood at Year 1.
339584|NCT01147653|P1|Participant Flow|Autologous UCB Reinfusion First, Then Placebo|Subjects receive autologous umbilical cord blood at Baseline, then Placebo at Year 1.
339585|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|"All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions.~Autologous Umbilical Cord Blood or Placebo: All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions. Patients will be randomized to receive their autologous umbilical cord blood cells first or placebo first. Subjects will receive both infusions but will be randomized and blinded by which they are receiving first and second."
339586|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|Patients will be randomized to receive their autologous umbilical cord blood cells first or placebo first. Subjects will receive both infusions but will be randomized and blinded by which they are receiving first and second.
339587|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|Patients will be randomized to receive their autologous umbilical cord blood cells first or placebo first. Subjects will receive both infusions but will be randomized and blinded by which they are receiving first and second.
339588|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
339589|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First, Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
339590|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
339591|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
339592|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
339593|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
339594|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
339595|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
339596|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
339597|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First, Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
339598|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
339599|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First, Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
339600|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
339601|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
339602|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
339603|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
339604|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
339605|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
339609|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
339610|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
339611|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
339612|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
339613|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
339614|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
339615|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
339616|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
339617|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
339618|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
339619|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
339620|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive Placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
339621|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than Placebo at Year 1.
339622|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo first, then autologous umbilical cord blood cell reinfusion at Year 1.
339623|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells first, than placebo at Year 1.
339624|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
339625|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
339626|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
339627|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
339628|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo first, then autologous umbilical cord blood cell reinfusion at Year 1.
339629|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells first, than placebo at Year 1.
339630|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
339631|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First, Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
339632|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive Placebo at Baseline, then autologous umbilical cord blood at Year 1.
339633|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First, Then Placebo|Subjects receive autologous umbilical cord blood at Baseline, then Placebo at Year 1.
339634|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|"Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.~Autologous UCB Reinfusion: Autologous umbilical cord blood (UCB) reinfusion~Placebo: Placebo"
339635|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|"Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.~Autologous UCB Reinfusion: Autologous umbilical cord blood (UCB) reinfusion~Placebo: Placebo"
339636|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
339637|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
339638|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
339639|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First, Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
339640|NCT01147653|E2|Reported Event|Placebo|"All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions.~Autologous Umbilical Cord Blood or Placebo: All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions. Patients will be randomized to receive their autologous umbilical cord blood cells first or placebo first. Subjects will receive both infusions but will be randomized and blinded by which they are receiving first and second."
339641|NCT01147653|E1|Reported Event|Autologous Umbilical Cord Blood Reinfusion|"All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions.~Autologous Umbilical Cord Blood or Placebo: All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions. Patients will be randomized to receive their autologous umbilical cord blood cells first or placebo first. Subjects will receive both infusions but will be randomized and blinded by which they are receiving first and second."
339642|NCT01147640|B3|Baseline|Total|Total of all reporting groups
352873|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
339643|NCT01147640|B2|Baseline|Meropenem With Matching Saline Placebo|meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
339644|NCT01147640|B1|Baseline|CXA 101/Tazobactam and Metronidazole|CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
339645|NCT01147640|P2|Participant Flow|Meropenem With Matching Saline Placebo|meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
339646|NCT01147640|P1|Participant Flow|CXA 101/Tazobactam and Metronidazole|CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
339647|NCT01147640|O2|Outcome|Meropenem With Matching Saline Placebo|meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
339648|NCT01147640|O1|Outcome|CXA 101/Tazobactam and Metronidazole|CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
339649|NCT01147640|O2|Outcome|Meropenem With Matching Saline Placebo|meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
339650|NCT01147640|O1|Outcome|CXA 101/Tazobactam and Metronidazole|CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
339651|NCT01147640|E2|Reported Event|Meropenem With Matching Saline Placebo|meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
339652|NCT01147640|E1|Reported Event|CXA 101/Tazobactam and Metronidazole|CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
339653|NCT01147627|B4|Baseline|Total|Total of all reporting groups
339654|NCT01147627|B3|Baseline|Thiazolidinedione|
339655|NCT01147627|B2|Baseline|Premixed Insulin Analog|
339656|NCT01147627|B1|Baseline|Exenatide|
339657|NCT01147627|P3|Participant Flow|Pioglitazone|Pioglitazone was commenced at a dose of 30 mg daily, increasing to 45 mg daily after 4 weeks.
339658|NCT01147627|P2|Participant Flow|Premixed Insulin Analog|Premixed insulin was injected twice-daily commencing with 0.4 IU/kg daily, with 50% given 15 minutes before breakfast and dinner respectively
339659|NCT01147627|P1|Participant Flow|Exenatide|5 µg was injected twice-daily subcutaneously increasing to 10 µg twice-daily after 4 weeks. Those who experienced hypoglycaemia frequently or could not tolerate adverse events were instructed to reduce the dose to 5 µg twice-daily.
339660|NCT01147627|O3|Outcome|Thiazolidinedione|
339661|NCT01147627|O2|Outcome|Premixed Insulin Analog|
339662|NCT01147627|O1|Outcome|Exenatide|
339663|NCT01147627|E3|Reported Event|Thiazolidinedione|
339664|NCT01147627|E2|Reported Event|Premixed Insulin Analog|
339665|NCT01147627|E1|Reported Event|Exenatide|
339666|NCT01147601|B3|Baseline|Total|Total of all reporting groups
339667|NCT01147601|B2|Baseline|Placebo|"Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily~Control (placebo) group: Control (placebo) group"
339668|NCT01147601|B1|Baseline|Topical 0.5% Timolol|"Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol.~topical 0.5% Timolol: topical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily"
339669|NCT01147601|P2|Participant Flow|Placebo|"Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily~Control (placebo) group: Control (placebo) group"
339670|NCT01147601|P1|Participant Flow|Topical 0.5% Timolol|"Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol.~topical 0.5% Timolol: topical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily"
339671|NCT01147601|O2|Outcome|Placebo|"Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily~Control (placebo) group: Control (placebo) group"
339672|NCT01147601|O1|Outcome|Topical 0.5% Timolol|"Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol.~topical 0.5% Timolol: topical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily"
339673|NCT01147601|E2|Reported Event|Placebo|"Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily~Control (placebo) group: Control (placebo) group"
339674|NCT01147601|E1|Reported Event|Topical 0.5% Timolol|"Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol.~topical 0.5% Timolol: topical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily"
339675|NCT01147497|B3|Baseline|Total|Total of all reporting groups
339676|NCT01147497|B2|Baseline|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
339677|NCT01147497|B1|Baseline|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
339678|NCT01147497|P2|Participant Flow|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
339679|NCT01147497|P1|Participant Flow|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
339680|NCT01147497|O2|Outcome|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
339681|NCT01147497|O1|Outcome|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
339682|NCT01147497|O2|Outcome|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
339683|NCT01147497|O1|Outcome|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
339684|NCT01147497|O2|Outcome|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
339685|NCT01147497|O1|Outcome|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
339686|NCT01147497|O2|Outcome|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
339687|NCT01147497|O1|Outcome|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
339689|NCT01147497|O1|Outcome|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
339692|NCT01147497|O2|Outcome|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
339693|NCT01147497|O1|Outcome|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
339694|NCT01147497|E2|Reported Event|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
339695|NCT01147497|E1|Reported Event|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
339696|NCT01147471|B3|Baseline|Total|Total of all reporting groups
339697|NCT01147471|B2|Baseline|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
339698|NCT01147471|B1|Baseline|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
339699|NCT01147471|P2|Participant Flow|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
339700|NCT01147471|P1|Participant Flow|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
339701|NCT01147471|O2|Outcome|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
339702|NCT01147471|O1|Outcome|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
339703|NCT01147471|O2|Outcome|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
339704|NCT01147471|O1|Outcome|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
339705|NCT01147471|O2|Outcome|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
339721|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
339829|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
339706|NCT01147471|O1|Outcome|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
339707|NCT01147471|O2|Outcome|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
339708|NCT01147471|O1|Outcome|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
339709|NCT01147471|O2|Outcome|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
339710|NCT01147471|O1|Outcome|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
339711|NCT01147471|E2|Reported Event|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
339712|NCT01147471|E1|Reported Event|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize stove-in segment. Post-operatively, the patients would receive standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system.~operative rib fix"
339713|NCT01147458|B1|Baseline|Entire Study Population|Includes groups randomized to receive PF-04191834 first, placebo first, PF-04191834 plus naproxen first, and naproxen first.
339714|NCT01147458|P4|Participant Flow|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
339715|NCT01147458|P3|Participant Flow|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
339716|NCT01147458|P2|Participant Flow|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
339717|NCT01147458|P1|Participant Flow|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
339718|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
339719|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
339720|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
339826|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
339722|NCT01147458|O2|Outcome|PF-04191834 600 mg BID + Naproxen 500 mg BID|PF-04191834 600 mg BID plus naproxen 500 mg BID administered either in Period 1 or Period 2
339723|NCT01147458|O1|Outcome|PF-04191834 600 mg BID|PF-04191834 600 mg BID administered either in Period 1 or Period 2
339724|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
339725|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
339726|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
339727|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
339728|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
339729|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
339730|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
339731|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
339732|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
339733|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
339734|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
339735|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
339736|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
339737|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
339738|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
339739|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
339740|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
339741|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
339742|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
339743|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
339744|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
339745|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
339746|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
339747|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
339748|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
339749|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
339750|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
339751|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
339827|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
339752|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
339753|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
339754|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
339755|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
339756|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
339757|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
339758|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
339759|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
339760|NCT01147458|E4|Reported Event|Naproxen|Naproxen 500 mg BID administered either in Period 1 or Period 2
339761|NCT01147458|E3|Reported Event|PF-04191834 + Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID administered either in Period 1 or Period 2
339762|NCT01147458|E2|Reported Event|Placebo|Placebo administered either in Period 1 or Period 2
339763|NCT01147458|E1|Reported Event|PF-04191834|PF-04191834 600 mg BID administered either in Period 1 or Period 2
339764|NCT01147406|B7|Baseline|Total|Total of all reporting groups
339765|NCT01147406|B6|Baseline|Placebo|Not Active - Placebo
339766|NCT01147406|B5|Baseline|Cohort 6|N6022 - Active 35 mg
339767|NCT01147406|B4|Baseline|Cohort 5|N6022 - Active 25 mg
339768|NCT01147406|B3|Baseline|Cohort 3|N6022 - Active 45 mg (actual *27.5 mg)
339769|NCT01147406|B2|Baseline|Cohort 2 & 4|N6022 - Active 15 mg
339770|NCT01147406|B1|Baseline|Cohort 1|N6022 - Active 5 mg
339771|NCT01147406|P6|Participant Flow|Placebo|Not Active - Placebo
339772|NCT01147406|P5|Participant Flow|Cohort 6|35 mg of N6022 was given intravenously daily for 7 days
339773|NCT01147406|P4|Participant Flow|Cohort 5|25 mg of N6022 was given intravenously daily for 7 days
339774|NCT01147406|P3|Participant Flow|Cohort 3|45 mg of N6022 was to be given intravenously daily for 7 days however, the actual amount was 27.5 mg.
339775|NCT01147406|P2|Participant Flow|Cohorts 2 and 4|15 mg of N6022 was given intravenously daily for 7 days
339776|NCT01147406|P1|Participant Flow|Cohort 1|5 mg of N6022 was given intravenously daily for 7 days
339777|NCT01147406|O6|Outcome|Placebo|Not Active - Placebo
339778|NCT01147406|O5|Outcome|Cohort 6|N6022 - Active 35 mg
339779|NCT01147406|O4|Outcome|Cohort 5|N6022 - Active 25 mg
339780|NCT01147406|O3|Outcome|Cohort 3|N6022 - Active 45 mg (actual *27.5 mg)
339781|NCT01147406|O2|Outcome|Cohort 2 and 4|N6022 - Active 15 mg
339782|NCT01147406|O1|Outcome|Cohort 1|N6022 - Active 5 mg
339783|NCT01147406|O6|Outcome|Placebo|Not Active - Placebo
339784|NCT01147406|O5|Outcome|Cohort 6|N6022 - Active 35 mg
339785|NCT01147406|O4|Outcome|Cohort 5|N6022 - Active 25 mg
339786|NCT01147406|O3|Outcome|Cohort 3|N6022 - Active 45 mg
339787|NCT01147406|O2|Outcome|Cohort 2 and 4|N6022 - Active 15 mg
339788|NCT01147406|O1|Outcome|Cohort 1|N6022 - Active 5 mg
339789|NCT01147406|E6|Reported Event|Placebo|Not Active - Placebo
339790|NCT01147406|E5|Reported Event|Cohort 6|N6022 - Active 35 mg
339791|NCT01147406|E4|Reported Event|Cohort 5|N6022 - Active 25 mg
339792|NCT01147406|E3|Reported Event|Cohort 3|N6022 - Active 45 mg
339793|NCT01147406|E2|Reported Event|Cohort 2 and 4|N6022 - Active 15 mg
339794|NCT01147406|E1|Reported Event|Cohort 1|N6022 - Active 5 mg
339795|NCT01147393|B1|Baseline|All Subjects|"two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.~90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over ~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.~veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2."
339796|NCT01147393|P1|Participant Flow|All Subjects|"two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.~90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over ~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.~veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2."
339797|NCT01147393|O1|Outcome|All Subjects|"two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.~90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over ~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.~veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2."
339798|NCT01147393|O1|Outcome|All Subjects|"two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.~90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over ~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.~veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2."
339799|NCT01147393|O1|Outcome|All Subjects|"two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.~90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over ~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.~veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2."
339800|NCT01147393|O1|Outcome|All Subjects|"two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.~90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over ~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.~veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2."
339801|NCT01147393|E2|Reported Event|Dose Level -1|veltzumab: 200 mg/m2 Unconjugated epratuzumab: 1.5 mg/kg 111-In-epratuzumab: 5 mCi 90-Y-epratuzumab: 10 mCi/m2
339802|NCT01147393|E1|Reported Event|Dose Level 1|veltzumab: 200 mg/m2 Unconjugated epratuzumab: 1.5 mg/kg 111-In-epratuzumab: 5 mCi 90-Y-epratuzumab: 15 mCi/m2
339803|NCT01147380|B3|Baseline|Total|Total of all reporting groups
339804|NCT01147380|B2|Baseline|Large Dose|"The number of inoculation cells is between 100 and 1000 million cells~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
339805|NCT01147380|B1|Baseline|Small Dose|"The number of inoculation cells is between 10 and 100 million cells.~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
339806|NCT01147380|P2|Participant Flow|Large Dose|"The number of inoculation cells is between 100 and 1000 million cells~Liver NK cell inoculation: Liver transplant recipients will receive liver NK cell inoculation several days after liver transplantation."
339807|NCT01147380|P1|Participant Flow|Small Dose|"The number of inoculation cells is between 10 and 100 million cells.~Liver NK cell inoculation: Liver transplant recipients will receive liver NK cell inoculation several days after liver transplantation."
339808|NCT01147380|O2|Outcome|Large Dose|"From the donor liver perfusate, mononuclear cell will be extracted and cultured. Then, the cells will be stimulated with IL-2. The number of inoculation cells(mainly NK cells) is between 100 and 1000 million cells. The cells will be given to the liver transplant recipient who had the same donor for liver and liver perfusate.Patient of this arm receive large dose of liver NK cell inoculation as described.~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
339809|NCT01147380|O1|Outcome|Small Dose|"From the donor liver perfusate, mononuclear cell will be extracted and cultured. Then, the cells will be stimulated with IL-2. The number of inoculation cells( mainly NK cells) is between 10 and 100 million cells. The cells will be given to the liver transplant recipient who had the same donor for liver and liver perfusate. Patient of this arm receive small dose of liver NK cell inoculation as described.~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
339810|NCT01147380|O2|Outcome|Large Dose|"The number of inoculation cells is between 100 and 1000 million cells~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
339811|NCT01147380|O1|Outcome|Small Dose|"The number of inoculation cells is between 10 and 100 million cells.~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
339812|NCT01147380|E2|Reported Event|Large Dose|"The number of inoculation cells is between 100 and 1000 million cells~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
339813|NCT01147380|E1|Reported Event|Small Dose|"The number of inoculation cells is between 10 and 100 million cells.~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
339814|NCT01147341|B3|Baseline|Total|Total of all reporting groups
339815|NCT01147341|B2|Baseline|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
339816|NCT01147341|B1|Baseline|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
339817|NCT01147341|P2|Participant Flow|Placebo|"Reporting group: Placebo : prefilled saline syringe during the Double Blind Period~10 patients entered"
339818|NCT01147341|P1|Participant Flow|Active Treatment With Cimzia|"Reporting group: Cimzia : prefilled 200mg Cimzia syringes. Cimzia 400mg SC at baseline, weeks 2 and 4 and Cimzia 200mg SC at weeks 6, 8, and 10 during the Double Blind Portion.~Cimzia 400mg SC at weeks 12, 14, and 16 and Cimzia 200mg SC at weeks 18, 20, and 22.~27 patients entered the Double Blind Portion."
339819|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
339820|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
339821|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
339822|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
339823|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
339824|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
339825|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
339830|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
339831|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
339832|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
339833|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
339834|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
339835|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
339836|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
339837|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
339838|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
339839|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
339840|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
339841|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
339842|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
339843|NCT01147341|E2|Reported Event|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
339844|NCT01147341|E1|Reported Event|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
339845|NCT01147302|B3|Baseline|Total|Total of all reporting groups
339846|NCT01147302|B2|Baseline|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
339847|NCT01147302|B1|Baseline|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
339848|NCT01147302|P2|Participant Flow|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
339849|NCT01147302|P1|Participant Flow|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
339850|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
339851|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
339852|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
339853|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
339854|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
339855|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
339856|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
339857|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
339858|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
339859|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
339860|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
339888|NCT01147250|O1|Outcome|Placebo|Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).
340214|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
339861|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
339862|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
339863|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
339864|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
339865|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
339866|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
339867|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
339868|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
339869|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
339870|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
339871|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
339872|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
339873|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
339874|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
339875|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
339876|NCT01147302|E2|Reported Event|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
339877|NCT01147302|E1|Reported Event|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
339878|NCT01147250|B3|Baseline|Total|Total of all reporting groups
339879|NCT01147250|B2|Baseline|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
339880|NCT01147250|B1|Baseline|Placebo|Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).
339881|NCT01147250|P2|Participant Flow|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
339882|NCT01147250|P1|Participant Flow|Placebo|Placebo matched to lixisenatide once daily (QD) subcutaneously (SC) up to end of treatment (median exposure: 23 months).
339883|NCT01147250|O2|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
339884|NCT01147250|O1|Outcome|Placebo|Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).
339885|NCT01147250|O2|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
339886|NCT01147250|O1|Outcome|Placebo|Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).
339887|NCT01147250|O2|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
339889|NCT01147250|O2|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
339890|NCT01147250|O1|Outcome|Placebo|Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).
339891|NCT01147250|E2|Reported Event|Lixisenatide|Participants exposed to Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to 225 weeks. (Median exposure: 22 months)
339892|NCT01147250|E1|Reported Event|Placebo|Participants exposed to Placebo matched to lixisenatide QD. (Median exposure: 23 months)
339893|NCT01147172|B1|Baseline|Elevess|"Gel implant (dermal filler) composed of hyaluronan produced by Streptococcus equi (bacterial fermentation) that is cross-linked and suspended in phosphate buffered saline with 0.3% lidocaine HCl and 0.1% sodium metabisulfite~Elevess : Injectable gel, 0.5mL or 1.0mL material supplied in a 1.0mL pre-filled sterile glass syringe with two 30 gauge needles"
339894|NCT01147172|P1|Participant Flow|Elevess|"Gel implant (dermal filler) composed of hyaluronan produced by Streptococcus equi (bacterial fermentation) that is cross-linked and suspended in phosphate buffered saline with 0.3% lidocaine HCl and 0.1% sodium metabisulfite~Elevess : Injectable gel, 0.5mL or 1.0mL material supplied in a 1.0mL pre-filled sterile glass syringe with two 30 gauge needles"
339895|NCT01147172|O1|Outcome|Elevess|Subjects received injection(s) and exhibited pigmentation changes at End of Study.
339896|NCT01147172|O1|Outcome|Elevess|Subjects received injection(s) and exhibited pigmentation changes at End of Study.
339897|NCT01147172|O1|Outcome|Elevess|Subjects received injection(s) and exhibited pigmentation changes at End of Study.
339898|NCT01147172|O1|Outcome|Elevess|Subjects received injection(s) and exhibited pigmentation changes at End of Study.
339899|NCT01147172|O1|Outcome|Elevess|Subjects that received injection(s) of Elevess and exhibited keloid formation at End of Study.
339900|NCT01147172|O1|Outcome|Elevess|Subjects that received injection(s) of Elevess and exhibited keloid formation.
339901|NCT01147172|O1|Outcome|Elevess|Subjects that received injection(s) of Elevess and exhibited keloid formation.
339902|NCT01147172|O1|Outcome|Elevess|Subjects that received injection(s) of Elevess and exhibited keloid formation.
339903|NCT01147172|E1|Reported Event|Safety Population|All Subjects receiving treatment of nasolabial folds (NLF) with injection of Elevess.
339904|NCT01147068|B8|Baseline|Total|Total of all reporting groups
339905|NCT01147068|B7|Baseline|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339906|NCT01147068|B6|Baseline|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339907|NCT01147068|B5|Baseline|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339908|NCT01147068|B4|Baseline|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339909|NCT01147068|B3|Baseline|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339910|NCT01147068|B2|Baseline|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339911|NCT01147068|B1|Baseline|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339912|NCT01147068|P7|Participant Flow|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339913|NCT01147068|P6|Participant Flow|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339914|NCT01147068|P5|Participant Flow|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339915|NCT01147068|P4|Participant Flow|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339916|NCT01147068|P3|Participant Flow|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339917|NCT01147068|P2|Participant Flow|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339918|NCT01147068|P1|Participant Flow|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339919|NCT01147068|O7|Outcome|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
340081|NCT01146782|O1|Outcome|Primary Endpoint Cohort|The Treatment group (Primary Endpoint Cohort) includes subjects with an evaluable control (without Attune system) and treatment (with Attune system) PSG.
339920|NCT01147068|O6|Outcome|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339921|NCT01147068|O5|Outcome|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339922|NCT01147068|O4|Outcome|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339923|NCT01147068|O3|Outcome|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339924|NCT01147068|O2|Outcome|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339925|NCT01147068|O1|Outcome|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339926|NCT01147068|O7|Outcome|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339927|NCT01147068|O6|Outcome|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339928|NCT01147068|O5|Outcome|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339929|NCT01147068|O4|Outcome|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339930|NCT01147068|O3|Outcome|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339931|NCT01147068|O2|Outcome|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339932|NCT01147068|O1|Outcome|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339933|NCT01147068|O7|Outcome|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339934|NCT01147068|O6|Outcome|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339935|NCT01147068|O5|Outcome|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339936|NCT01147068|O4|Outcome|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339937|NCT01147068|O3|Outcome|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339938|NCT01147068|O2|Outcome|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339939|NCT01147068|O1|Outcome|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339940|NCT01147068|E7|Reported Event|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339941|NCT01147068|E6|Reported Event|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339942|NCT01147068|E5|Reported Event|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339943|NCT01147068|E4|Reported Event|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339944|NCT01147068|E3|Reported Event|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
340085|NCT01146782|E1|Reported Event|Safety Cohort|Device related adverse events are presented for the Safety Cohort.
340086|NCT01146613|B3|Baseline|Total|Total of all reporting groups
339945|NCT01147068|E2|Reported Event|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339946|NCT01147068|E1|Reported Event|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
339947|NCT01147055|B1|Baseline|Entire Study Population|Includes participants randomized to receive crizotinib 250 mg IRT first and then crizotinib 250 mg + rifampin 600 mg.
339948|NCT01147055|P2|Participant Flow|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in fasted state from Day 1 to Day 14. A single oral dose of crizotinib 250 mg IRTs was administered on Day 9 in second intervention period. A washout period of at least 14 days was maintained between each period.
339949|NCT01147055|P1|Participant Flow|Crizotinib 250 mg|Single oral dose of crizotinib 250 milligram (mg) immediate-release tablet (IRT) on Day 1 in first intervention period. A washout period of at least 14 days was maintained between each period.
339950|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
339951|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
339952|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
339953|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
339954|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
339955|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
339956|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
339957|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
339958|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
339959|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
339960|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
339961|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
339962|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
339963|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
339964|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
339965|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
339966|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
339967|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
339968|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
339969|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
339970|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
339971|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
339972|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
339973|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
339974|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
339975|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
339976|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
339977|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
340082|NCT01146782|O1|Outcome|Primary Endpoint Cohort|The Treatment group (Primary Endpoint Cohort) includes subjects with an evaluable control (without Attune system) and treatment (with Attune system) PSG.
339978|NCT01147055|E2|Reported Event|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
339979|NCT01147055|E1|Reported Event|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
339980|NCT01147042|B3|Baseline|Total|Total of all reporting groups
339981|NCT01147042|B2|Baseline|Autosomal Recessive CGD With p47|"Subjects in this cohort have autosomal recessive CGD resulting from a documented p47phox gene mutation.~Subjects will then be started on a 12 week course of IFN treatment. Subjects will have a subcutaneous injection of 50 mcg/m2 once per week (Monday) for 4 weeks, twice per week (Monday and Thursday) for 4 weeks, then thrice per week (Monday, Wednesday, Friday) for 4 weeks."
339982|NCT01147042|B1|Baseline|gp91 CGD With Relatively High Baseline Superoxide|"Subjects in this cohort have X-linked CGD resulting from a documented missense gene and superoxide production by cytochrome c reduction assay at baseline of greater than 2.5 nmol/106 cells per hour.~Following a washout period subjects have a subcutaneous injection of 50 mcg per meter squared administered once per week, Monday, for 4 weeks, twice per week, Monday and Thursday, for 4 weeks, then thrice per week, Monday, Wednesday, Friday, for 4 weeks for a total of 12 weeks of Interferon-gamma treatment."
339983|NCT01147042|P2|Participant Flow|Autosomal Recessive CGD With p47|Patients with Autosomal Recessive Chronic Granulomatous Disease (CGD) with p47 phox mutation
339984|NCT01147042|P1|Participant Flow|gp91 CGD With HIGH Baseline Superoxide|Patients with X-linked Chronic Granulomatous Disease (CGD) with a missense gp91phox mutation and relatively high baseline superoxide production
339985|NCT01147042|O2|Outcome|Autosomal Recessive CGD With p47|Patients with Autosomal Recessive Chronic Granulomatous Disease (CGD) with p47 phox mutation
339986|NCT01147042|O1|Outcome|gp91 CGD With HIGH Baseline Superoxide|Patients with X-linked Chronic Granulomatous Disease (CGD) with a missense gp91phox mutation and relatively high baseline superoxide production
339987|NCT01147042|E1|Reported Event|gp91 CGD With Relatively High Baseline Superoxide|Patients with X-linked Chronic Granulomatous Disease (CGD) with a missense gp91phox mutation and relatively high baseline superoxide production
339988|NCT01146951|B3|Baseline|Total|Total of all reporting groups
339989|NCT01146951|B2|Baseline|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
339990|NCT01146951|B1|Baseline|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
339991|NCT01146951|P2|Participant Flow|Placebo|Placebo : Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
339992|NCT01146951|P1|Participant Flow|Rufinamide (E2080)|"Rufinamide : Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period.~Target maintenance dose:~15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)"
339993|NCT01146951|O2|Outcome|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
339994|NCT01146951|O1|Outcome|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
339995|NCT01146951|O2|Outcome|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
339996|NCT01146951|O1|Outcome|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
339997|NCT01146951|O2|Outcome|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
339998|NCT01146951|O1|Outcome|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
339999|NCT01146951|O2|Outcome|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
340083|NCT01146782|O1|Outcome|Safety Cohort|The Safety Cohort is comprised of all subjects with at least one night of Winx therapy usage.
340087|NCT01146613|B2|Baseline|Sugar Pill|Placebo: identical matched placebo x 2, 2xday, 13 weeks
340000|NCT01146951|O1|Outcome|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
340001|NCT01146951|O2|Outcome|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
340002|NCT01146951|O1|Outcome|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
340003|NCT01146951|E2|Reported Event|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
340004|NCT01146951|E1|Reported Event|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
340005|NCT01146912|B8|Baseline|Total|Total of all reporting groups
340006|NCT01146912|B7|Baseline|Delayed Pediatrics: Usual Care|
340007|NCT01146912|B6|Baseline|Delayed Pediatrics: Conventional Text Message|
340008|NCT01146912|B5|Baseline|Delayed Pediatrics: Interactive Text Message|
340009|NCT01146912|B4|Baseline|Pregnant Women: Usual Care|
340010|NCT01146912|B3|Baseline|Pregnant Women: Text Message|
340011|NCT01146912|B2|Baseline|Automated Phone Call From Clinic Only|Receipt of automated phone call from clinic
340012|NCT01146912|B1|Baseline|Text Message Vaccine Reminders/Automated Telephone Call|Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
340013|NCT01146912|P8|Participant Flow|Parents|Included in enrollment but not in outcomes which are on child level
340014|NCT01146912|P7|Participant Flow|Delayed Pediatric: Usual Care|Vaccination of children not yet vaccinated by mid-November: usual care
340015|NCT01146912|P6|Participant Flow|Delayed Pediatric: Conventional Text Message|Vaccination of children not yet vaccinated by mid-November: conventional text message
340016|NCT01146912|P5|Participant Flow|Delayed Pediatrics: Interactive Text Message Vaccine Reminders|Vaccination of children not yet vaccinated by mid-November: interactive message
340017|NCT01146912|P4|Participant Flow|Pregnant Women: Usual Care|Received usual care
340018|NCT01146912|P3|Participant Flow|Pregnant Women: Text Message|Received text message reminders
340019|NCT01146912|P2|Participant Flow|Pediatric: Automated Phone Call From Clinic Only|Receipt of automated phone call from clinic
340020|NCT01146912|P1|Participant Flow|Pediatric Text Message Vaccine Reminders/Automated Phone Call|Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
340021|NCT01146912|O3|Outcome|Delayed Pediatric: Usual Care|Vaccination of children not yet vaccinated by mid-November: usual care
340022|NCT01146912|O2|Outcome|Delayed Pediatric: Conventional Text Message|Vaccination of children not yet vaccinated by mid-November: conventional text message
340023|NCT01146912|O1|Outcome|Delayed Pediatrics: Interactive Text Message Vaccine Reminders|Vaccination of children not yet vaccinated by mid-November: interactive message
340024|NCT01146912|O2|Outcome|Pregnant Women: Usual Care|
340025|NCT01146912|O1|Outcome|Pregnant Women: Text Message|
340026|NCT01146912|O2|Outcome|Automated Phone Call From Clinic|"Receipt of automated phone call from clinic~automated call: Automated call"
340027|NCT01146912|O1|Outcome|Text Message Vaccine Reminders|"Receipt of text message vaccine reminders~Text Message: Text message vaccine reminders~automated call: Automated call"
340028|NCT01146912|O2|Outcome|Pediatric: Automated Phone Call From Clinic Only|Receipt of automated phone call from clinic
340029|NCT01146912|O1|Outcome|Pediatric: Text Message Vaccine Reminders/Automated Phone Call|Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
340030|NCT01146912|O2|Outcome|Pediatric: Automated Phone Call From Clinic Only|Receipt of automated phone call from clinic
340031|NCT01146912|O1|Outcome|Pediatric: Text Message Vaccine-reminders/Automated Phone Call|Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
340032|NCT01146912|E7|Reported Event|Delayed Pediatric: Usual Care|
340033|NCT01146912|E6|Reported Event|Delayed Pediatric: Conventional Text Message|
340034|NCT01146912|E5|Reported Event|Delayed Pediatric: Interactive Text Message|
340035|NCT01146912|E4|Reported Event|Pregnant Women: Usual Care|
340036|NCT01146912|E3|Reported Event|Pregnant Women: Text Message|
340037|NCT01146912|E2|Reported Event|Pediatric: Automated Phone Call From Clinic Only|Receipt of automated phone call from clinic
340038|NCT01146912|E1|Reported Event|Pediatric: Text Message Vaccine-reminders/Automated Phone Call|Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
340039|NCT01146873|B3|Baseline|Total|Total of all reporting groups
340084|NCT01146782|O1|Outcome|Primary Endpoint Cohort|The Treatment group (Primary Endpoint Cohort) includes subjects with an evaluable control (without Attune system) and treatment (with Attune system) PSG.
340144|NCT01146418|B3|Baseline|Total|Total of all reporting groups
340040|NCT01146873|B2|Baseline|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen. Efavirenz was prescribed once daily in the evening at 200 mg for weights of 10 kg to 13.9 kg (22-30 lb) and 300mg for weights of 14 kg to 24.9 kg (31-55 lb). Efavirenz was available in 50-mg and 200-mg capsules. If children were unable to swallow capsules, caregivers were shown how to open the capsules and dissolve the contents in water.
340041|NCT01146873|B1|Baseline|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen. Ritonavir-boosted lopinavir syrup was given twice per day at 230 mg/m^2 per dose. Children able to swallow tablets were given 1 tablet twice per day (200 mg lopinavir/50 mg ritonavir) if body surface area was less than 0.9m^2 or 2 tablets twice per day if body surface area was 0.9m^2 or higher.
340042|NCT01146873|P2|Participant Flow|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen. Efavirenz was prescribed once daily in the evening at 200 mg for weights of 10 kg to 13.9 kg (22-30 lb) and 300mg for weights of 14 kg to 24.9 kg (31-55 lb). Efavirenz was available in 50-mg and 200-mg capsules. If children were unable to swallow capsules, caregivers were shown how to open the capsules and dissolve the contents in water.
340043|NCT01146873|P1|Participant Flow|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen. Ritonavir-boosted lopinavir syrup was given twice per day at 230 mg/m^2 per dose. Children able to swallow tablets were given 1 tablet twice per day (200 mg lopinavir/50 mg ritonavir) if body surface area was less than 0.9m^2 or 2 tablets twice per day if body surface area was 0.9m^2 or higher.
340044|NCT01146873|O2|Outcome|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen
340045|NCT01146873|O1|Outcome|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen
340046|NCT01146873|O2|Outcome|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen
340047|NCT01146873|O1|Outcome|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen
340048|NCT01146873|O2|Outcome|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen
340049|NCT01146873|O1|Outcome|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen
340050|NCT01146873|O2|Outcome|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen
340051|NCT01146873|O1|Outcome|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen
340052|NCT01146873|O2|Outcome|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen
340053|NCT01146873|O1|Outcome|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen
340054|NCT01146873|E2|Reported Event|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen. Efavirenz was prescribed once daily in the evening at 200 mg for weights of 10 kg to 13.9 kg (22-30 lb) and 300mg for weights of 14 kg to 24.9 kg (31-55 lb). Efavirenz was available in 50-mg and 200-mg capsules. If children were unable to swallow capsules, caregivers were shown how to open the capsules and dissolve the contents in water.
340055|NCT01146873|E1|Reported Event|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen. Ritonavir-boosted lopinavir syrup was given twice per day at 230 mg/m^2 per dose. Children able to swallow tablets were given 1 tablet twice per day (200 mg lopinavir/50 mg ritonavir) if body surface area was less than 0.9m^2 or 2 tablets twice per day if body surface area was 0.9m^2 or higher
340056|NCT01146860|B3|Baseline|Total|Total of all reporting groups
340057|NCT01146860|B2|Baseline|Placebo|sugar coated tablets
340058|NCT01146860|B1|Baseline|BNO 1016|sugar coated tablets
340059|NCT01146860|P2|Participant Flow|Placebo|sugar coated tablets of identical appearance to active treatment
340060|NCT01146860|P1|Participant Flow|BNO 1016|sugar coated tablets with dry extract (80 mg) of 5 herbal drugs; daily dose: 480 mg (2 tablets tid)
340061|NCT01146860|O2|Outcome|Placebo|sugar coated tablets
340062|NCT01146860|O1|Outcome|BNO 1016|sugar coated tablets
340063|NCT01146860|O2|Outcome|Placebo|sugar coated tablets
340064|NCT01146860|O1|Outcome|BNO 1016|sugar coated tablets
340065|NCT01146860|O2|Outcome|Placebo|sugar coated tablets
340066|NCT01146860|O1|Outcome|BNO 1016|sugar coated tablets
340067|NCT01146860|O2|Outcome|Placebo|sugar coated tablets
340068|NCT01146860|O1|Outcome|BNO 1016|sugar coated tablets
340069|NCT01146860|O2|Outcome|Placebo|sugar coated tablets
340070|NCT01146860|O1|Outcome|BNO 1016|sugar coated tablets
340071|NCT01146860|E2|Reported Event|Placebo|sugar coated tablets
340072|NCT01146860|E1|Reported Event|BNO 1016|sugar coated tablets
340073|NCT01146808|B1|Baseline|ADV Plus Hepatitis B Vaccination Group|This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
340074|NCT01146808|P1|Participant Flow|ADV Plus Hepatitis B Vaccination Group|This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
340075|NCT01146808|O1|Outcome|ADV Plus Hepatitis B Vaccination Group|This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
340076|NCT01146808|O1|Outcome|ADV Plus Hepatitis B Vaccination Group|This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
340077|NCT01146808|O1|Outcome|ADV Plus Hepatitis B Vaccination Group|This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
340078|NCT01146808|E1|Reported Event|ADV Plus Hepatitis B Vaccination Group|This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
340079|NCT01146782|B1|Baseline|Safety Cohort|Demographics and Baseline Characteristics are presented for the Safety Cohort (N=146)
340080|NCT01146782|P1|Participant Flow|Sleep Apnea Treatment (Primary Endpoint Cohort)|The Treatment group (Primary Endpoint Cohort) includes subjects with an evaluable control (without Attune system) and treatment (with Attune system) polysomnogram (PSG).
340088|NCT01146613|B1|Baseline|Varenicline|"Varenicline Tartrate~Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks"
340089|NCT01146613|P2|Participant Flow|Sugar Pill|Placebo: identical matched placebo x 2, 2xday, 13 weeks
340090|NCT01146613|P1|Participant Flow|Varenicline|"Varenicline Tartrate~Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks"
340091|NCT01146613|O2|Outcome|Sugar Pill|Placebo: identical matched placebo x 2, 2xday, 13 weeks
340092|NCT01146613|O1|Outcome|Varenicline|"Varenicline Tartrate~Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks"
340093|NCT01146613|E2|Reported Event|Sugar Pill|Placebo: identical matched placebo x 2, 2xday, 13 weeks
340094|NCT01146613|E1|Reported Event|Varenicline|"Varenicline Tartrate~Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks"
340095|NCT01146600|B3|Baseline|Total|Total of all reporting groups
340096|NCT01146600|B2|Baseline|Placebo, Then Clarithromycin|"Subjects will be randomized to group A or group B. The order of presentation of placebo and clarithromycin will be opposite in these two groups, but investigators and subjects will remain blinded to group allocation and order of treatment presentation within the groups.~Placebo then Clarithromycin : Matched placebo po bid (with breakfast and lunch) for two weeks, then one week with no intervention, then clarithromycin 500 mg po bid (with breakfast and lunch) for two weeks"
340097|NCT01146600|B1|Baseline|Clarithromycin, Then Placebo|"Subjects will be randomized to group A or group B. The order of presentation of placebo and clarithromycin will be opposite in these two groups, but investigators and subjects will remain blinded to group allocation and order of treatment presentation within the groups.~Clarithromycin followed by placebo : Clarithromycin 500 mg po bid (with breakfast and lunch) for two weeks, then one week with no medication, then matched placebo po bid (with breakfast and lunch) for two weeks."
340098|NCT01146600|P2|Participant Flow|Placebo, Then Clarithromycin|Subjects randomized to receive placebo first (for two weeks), then clarithromycin (for an additional two weeks, following the washout)
340099|NCT01146600|P1|Participant Flow|Clarithromycin, Then Placebo|Subjects randomized to receive clarithromycin first (for two weeks), then matched placebo (for an additional two weeks, following the washout)
340100|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
340101|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
340102|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
340103|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
340104|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
340105|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
340106|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
340107|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
340108|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
340109|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
340110|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
340111|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
340112|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
340113|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
340114|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
340115|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
340116|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
340117|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
340118|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
340119|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
340120|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
340121|NCT01146600|E2|Reported Event|Placebo|Matched placebo with breakfast and with lunch for two weeks
340122|NCT01146600|E1|Reported Event|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
340123|NCT01146457|B6|Baseline|Total|Total of all reporting groups
340124|NCT01146457|B5|Baseline|Morphine 100|Morphine 100 micrograms
340125|NCT01146457|B4|Baseline|Hine 75|Morphine 75 micrograms
340126|NCT01146457|B3|Baseline|Morphine 50|Morphine 50 micrograms
340127|NCT01146457|B2|Baseline|Morphine 25|Morphine 25 micrograms
340128|NCT01146457|B1|Baseline|Placebo|Saline control
340129|NCT01146457|P5|Participant Flow|Morphine 100|Morphine 100 micrograms: Active dosage
340130|NCT01146457|P4|Participant Flow|Morphine 75|Morphine 75 micrograms: Active dosage
340131|NCT01146457|P3|Participant Flow|Morphine 50|Morphine 50 micrograms: Active dosage
340132|NCT01146457|P2|Participant Flow|Morphine 25|Morphine 25 micrograms: Active dosage
340133|NCT01146457|P1|Participant Flow|Placebo|Saline: Saline Control
340134|NCT01146457|O5|Outcome|Morphine 100|Morphine 100 micrograms
340135|NCT01146457|O4|Outcome|Morphine 75|Morphine 75 micrograms
340136|NCT01146457|O3|Outcome|Morphine 50|Morphine 50 micrograms
340137|NCT01146457|O2|Outcome|Morphine 25|Morphine 25 micrograms
340138|NCT01146457|O1|Outcome|Control|Saline Control
340139|NCT01146457|E5|Reported Event|Morphine 100|Morphine: Active dosage
340140|NCT01146457|E4|Reported Event|Morphine 75|Morphine: Active dosage
340141|NCT01146457|E3|Reported Event|Morphine 50|Morphine: Active dosage
340142|NCT01146457|E2|Reported Event|Morphine 25|Morphine: Active dosage
340143|NCT01146457|E1|Reported Event|Placebo|Saline: Saline Control
340145|NCT01146418|B2|Baseline|recFSH 300 IU Women/Expectant Mothers|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
340146|NCT01146418|B1|Baseline|Corifollitropin Alfa 150 μg Women/Expectant Mothers|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
340147|NCT01146418|P4|Participant Flow|recFSH 300 IU Live-Born Infants|Infants born to eligible participants who received daily 300 IU recFSH in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice.
340148|NCT01146418|P3|Participant Flow|Corifollitropin Alfa 150 μg Live-Born Infants|Infants born to eligible participants who received a single injection of 150 μg corifollitropin alfa in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice.
340149|NCT01146418|P2|Participant Flow|recFSH 300 IU Women/Expectant Mothers|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
340150|NCT01146418|P1|Participant Flow|Corifollitropin Alfa 150 μg Women/Expectant Mothers|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
340151|NCT01146418|O2|Outcome|recFSH 300 IU Women/Expectant Mothers|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
340152|NCT01146418|O1|Outcome|Corifollitropin Alfa 150 μg Women/Expectant Mothers|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
340153|NCT01146418|O2|Outcome|recFSH 300 IU Women/Expectant Mothers|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
340154|NCT01146418|O1|Outcome|Corifollitropin Alfa 150 μg Women/Expectant Mothers|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
340155|NCT01146418|E6|Reported Event|recFSH 300 IU Follow-up Fetuses/Infants|Infants born to eligible participants who received daily 300 IU recFSH in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice
340156|NCT01146418|E5|Reported Event|Corifollitropin Alfa 150 μg Follow-up Fetuses/Infants|Infants born to eligible participants who received a single injection of 150 μg corifollitropin alfa in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice.
340157|NCT01146418|E4|Reported Event|recFSH 300 IU Expectant Mothers|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
340158|NCT01146418|E3|Reported Event|Corifollitropin Alfa 150 μg Expectant Mothers|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
340159|NCT01146418|E2|Reported Event|recFSH 300 IU Participants With ET|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
340160|NCT01146418|E1|Reported Event|Corifollitropin Alfa 150 μg Participants With ET|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
340161|NCT01146379|B5|Baseline|Total|Total of all reporting groups
340162|NCT01146379|B4|Baseline|Individual Maximum High Movement Dose|Intensive task-specific upper extremity rehabilitation: Individualized Maximum repetitions. The participants will continue to receive the training until performance plateaus. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
340163|NCT01146379|B3|Baseline|High Movement Dose, 9600 Total Reps|Intensive task-specific upper extremity rehabilitation: 9600 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
340164|NCT01146379|B2|Baseline|Medium Movement Dose, 6400 Total Reps|Intensive task-specific upper extremity rehabilitation: 6400 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
340165|NCT01146379|B1|Baseline|Low Movement Dose, 3200 Total Reps|Intensive task-specific upper extremity rehabilitation: 3200 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
340166|NCT01146379|P4|Participant Flow|Individual Maximum High Movement Dose|Intensive task-specific upper extremity rehabilitation: Individualized Maximum repetitions. The participants will continue to receive the training until performance plateaus. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
340167|NCT01146379|P3|Participant Flow|High Movement Dose, 9600 Total Reps|Intensive task-specific upper extremity rehabilitation: 9600 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
340168|NCT01146379|P2|Participant Flow|Medium Movement Dose, 6400 Total Reps|Intensive task-specific upper extremity rehabilitation: 6400 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
340169|NCT01146379|P1|Participant Flow|Low Movement Dose, 3200 Total Reps|Intensive task-specific upper extremity rehabilitation: 3200 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
340170|NCT01146379|O4|Outcome|Individual Maximum High Movement Dose|Intensive task-specific upper extremity rehabilitation: Individualized Maximum repetitions. The participants will continue to receive the training until performance plateaus. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
340171|NCT01146379|O3|Outcome|High Movement Dose, 9600 Total Reps|Intensive task-specific upper extremity rehabilitation: 9600 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
340172|NCT01146379|O2|Outcome|Medium Movement Dose, 6400 Total Reps|Intensive task-specific upper extremity rehabilitation: 6400 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
340207|NCT01145898|P1|Participant Flow|Trusopt|Patients with glaucoma taking Trusopt or Cosopt alone or with prostaglandin for at least 6 months
340208|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
340209|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
340210|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
352874|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
340173|NCT01146379|O1|Outcome|Low Movement Dose, 3200 Total Reps|Intensive task-specific upper extremity rehabilitation: 3200 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
340174|NCT01146379|E4|Reported Event|Individual Maximum High Movement Dose|Intensive task-specific upper extremity rehabilitation: Individualized Maximum repetitions. The participants will continue to receive the training until performance plateaus. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
340175|NCT01146379|E3|Reported Event|High Movement Dose, 9600 Total Reps|Intensive task-specific upper extremity rehabilitation: 9600 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
340176|NCT01146379|E2|Reported Event|Medium Movement Dose, 6400 Total Reps|Intensive task-specific upper extremity rehabilitation: 6400 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
340177|NCT01146379|E1|Reported Event|Low Movement Dose, 3200 Total Reps|Intensive task-specific upper extremity rehabilitation: 3200 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
340178|NCT01146288|B3|Baseline|Total|Total of all reporting groups
340179|NCT01146288|B2|Baseline|Furosemide First, Then Acetazolamide|intravenous furosemide 2 mg/5min. in first intervention period, intravenous acetazolamide 5 mg/kg/5 min. in second intervention period (after washout period).
340180|NCT01146288|B1|Baseline|Acetazolamide First, Then Furosemide|intravenous acetazolamide 5 mg/kg/5 min. in first intervention period, intravenous furosemide 2 mg/5min in second intervention period (after washout period).
340181|NCT01146288|P2|Participant Flow|Furosemide First , Than Acetazolamide|Intravenous furosemide 2 mg/5min in first intervention period and intravenous acetazolamide 5 mg/kg/5 min. in second intervention period (after washout period).
340182|NCT01146288|P1|Participant Flow|Acetazolamide First, Then Furosemide|Intravenous acetazolamide 5 mg/kg/5 min. in first intervention period and intravenous furosemide 2 mg/5min in second intervention period (after washout period).
340183|NCT01146288|O2|Outcome|Furosemide|intravenous furosemide 2 mg/5min.
340184|NCT01146288|O1|Outcome|Acetazolamide|intravenous acetazolamide 5 mg/kg/5 min.
340185|NCT01146288|O2|Outcome|Furosemide|intravenous furosemide 2 mg/5min.
340186|NCT01146288|O1|Outcome|Acetazolamide|intravenous acetazolamide 5 mg/kg/5 min.
340187|NCT01146288|E3|Reported Event|P-aminohippuric Acid|Intravenous priming dose of p-aminohippuric acid (8 mg/kg) before diuretics administration
340188|NCT01146288|E2|Reported Event|Furosemide|Intravenous furosemide 2 mg/5min
340189|NCT01146288|E1|Reported Event|Acetazolamide|Intravenous acetazolamide 5 mg/kg/5 min.
340190|NCT01146275|B1|Baseline|Participants in the Pilot Study 31GB0601|"This is an additional safety follow up 7-years post treatment, for subjects enroled in a pilot study using a previous formulation of Macrolane for breast augmentation.~Radiologial breast examination : MRI of breast, mammograophy and ultrasound of breast"
340191|NCT01146275|P1|Participant Flow|Participants in the Pilot Study 31GB0601|"This is an additional safety follow up 7-years post treatment, for subjects enroled in a pilot study using a previous formulation of Macrolane for breast augmentation.~Radiologial breast examination : MRI of breast, mammograophy and ultrasound of breast"
340192|NCT01146275|O1|Outcome|Participants in the Pilot Study 31GB0601|"This is an additional safety follow up 7-years post treatment, for subjects enrolled in a pilot study using a previous formulation of Macrolane (Hyaluronic acid) for breast augmentation.~Participants with AE/SAE since participation in study 31GB0106 or any findings at the breast examination, mammography, ultrasound or comprehensive MRI investigation"
340193|NCT01146275|O1|Outcome|Participants in the Pilot Study 31GB0601|"This is an additional safety follow up 7-years post treatment, for subjects enrolled in a pilot study using a previous formulation of Macrolane (Hyaluronic acid) for breast augmentation.~Radiologial breast examination : MRI of breast, mammography and ultrasound of breast The MRI investigation was performed to evaluate if the subjects has study product (Macrolane-a Hyaluronic acid) in their breast 7 years after the treatment."
340194|NCT01146275|E1|Reported Event|Participants in the Pilot Study 31GB0601|"This is an additional safety follow up 7-years post treatment, for subjects enrolled in a pilot study using a previous formulation of Macrolane for breast augmentation.~Radiologial breast examination : MRI of breast, mammograophy and ultrasound of breast"
340211|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
340212|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
340195|NCT01146054|B1|Baseline|SBRT and Gemzar|"Before stereotactic Body Radiotherapy (SBRT) 3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose (18F)) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles should resume/start up to 4 weeks following SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.~Device: CyberKnife based stereotactic radiotherapy"
340196|NCT01146054|P1|Participant Flow|SBRT and Gemzar|"3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose 18F-positron emission tomography/computerized tomography) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D (4 dimensional) pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles starts within 4 weeks of SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.~Fludeoxyglucose (18F): FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv"
340197|NCT01146054|O1|Outcome|SBRT and Gemzar|"3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose (18F)) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles starts within 4 weeks of SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.~Fludeoxyglucose (18F): FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv"
340198|NCT01146054|O1|Outcome|SBRT and Gemzar|"3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose (18F)) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles starts within 4 weeks of SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.~Fludeoxyglucose (18F): FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv"
340199|NCT01146054|O1|Outcome|SBRT and Gemzar|"3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose (18F)) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles starts within 4 weeks of SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.~Fludeoxyglucose (18F): FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv"
340200|NCT01146054|O1|Outcome|SBRT and Gemzar|"3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose (18F)) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles starts within 4 weeks of SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.~Fludeoxyglucose (18F): FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv"
340201|NCT01146054|O1|Outcome|SBRT and Gemzar|"3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose (18F)) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles starts within 4 weeks of SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.~Fludeoxyglucose (18F): FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv"
340202|NCT01146054|E1|Reported Event|SBRT and Gemzar|"3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose (18F)) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles starts within 4 weeks of SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.~Fludeoxyglucose (18F): FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv"
340203|NCT01145898|B3|Baseline|Total|Total of all reporting groups
340204|NCT01145898|B2|Baseline|Prostaglandin Alone|Patients with glaucoma taking prostaglandin alone for at least 6 months
340205|NCT01145898|B1|Baseline|Trusopt|Patients with glaucoma taking Trusopt or Cosopt alone or with prostaglandin for at least 6 months
340206|NCT01145898|P2|Participant Flow|Prostaglandin Alone|Patients with glaucoma taking prostaglandin alone for at least 6 months
340213|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
340215|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
340216|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
340217|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
340218|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
340219|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
340220|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
340221|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
340222|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
340223|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
340224|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
340225|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
340226|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
340227|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
340228|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
340229|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
340230|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
340231|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
340232|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
340233|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
340234|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
340235|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
340236|NCT01145898|E1|Reported Event|Glaucoma Patients|Patients with Glaucoma
340237|NCT01145755|B4|Baseline|Total|Total of all reporting groups
340238|NCT01145755|B3|Baseline|Placebo|Placebo
340239|NCT01145755|B2|Baseline|Duloxetine|Duloxetine 30 mg, 60 mg
340240|NCT01145755|B1|Baseline|AZD2066|AZD2066 12 mg, 18 mg
340241|NCT01145755|P3|Participant Flow|Placebo|Placebo
340242|NCT01145755|P2|Participant Flow|Duloxetine|Duloxetine 30 mg, 60 mg
340243|NCT01145755|P1|Participant Flow|AZD2066|AZD2066 12 mg, 18 mg
340244|NCT01145755|O3|Outcome|Placebo|Placebo
340245|NCT01145755|O2|Outcome|Duloxetine|Duloxetine 30 mg, 60 mg
340246|NCT01145755|O1|Outcome|AZD2066|AZD2066 12 mg, 18 mg
340247|NCT01145755|O3|Outcome|Placebo|Placebo
340248|NCT01145755|O2|Outcome|Duloxetine|Duloxetine 30 mg, 60 mg
340249|NCT01145755|O1|Outcome|AZD2066|AZD2066 12 mg, 18 mg
340250|NCT01145755|O3|Outcome|Placebo|Placebo
340251|NCT01145755|O2|Outcome|Duloxetine|Duloxetine 30 mg, 60 mg
340252|NCT01145755|O1|Outcome|AZD2066|AZD2066 12 mg, 18 mg
340253|NCT01145755|E3|Reported Event|Placebo|Placebo
340254|NCT01145755|E2|Reported Event|Duloxetine|Duloxetine 30 mg, 60 mg
340255|NCT01145755|E1|Reported Event|AZD2066|AZD2066 12 mg, 18 mg
340256|NCT01145638|B3|Baseline|Total|Total of all reporting groups
340257|NCT01145638|B2|Baseline|Iron Sulphate|"oral iron sulphate twice a day~iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks"
340258|NCT01145638|B1|Baseline|Iron Isomaltoside 1000|"Iron isomaltoside intravenously as bolus or infusion~iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose"
340259|NCT01145638|P2|Participant Flow|Iron Sulphate|"oral iron sulphate twice a day~iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks"
340260|NCT01145638|P1|Participant Flow|Iron Isomaltoside 1000|"Iron isomaltoside intravenously as bolus or infusion~iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose"
340261|NCT01145638|O2|Outcome|Iron Sulphate|"oral iron sulphate twice a day~iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks"
340262|NCT01145638|O1|Outcome|Iron Isomaltoside 1000|"Iron isomaltoside intravenously as bolus or infusion~iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose"
340263|NCT01145638|O2|Outcome|Iron Sulphate|"oral iron sulphate twice a day~iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks"
340264|NCT01145638|O1|Outcome|Iron Isomaltoside 1000|"Iron isomaltoside intravenously as bolus or infusion~iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose"
340265|NCT01145638|E2|Reported Event|Iron Sulphate|"oral iron sulphate twice a day~iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks"
340266|NCT01145638|E1|Reported Event|Iron Isomaltoside 1000|"Iron isomaltoside intravenously as bolus or infusion~iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose"
340267|NCT01145625|B3|Baseline|Total|Total of all reporting groups
340268|NCT01145625|B2|Baseline|5% MTF|"5% Minoxidil Topical Foam~5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
340269|NCT01145625|B1|Baseline|2% MTS|"2% Minoxidil Topical Solution~2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
340270|NCT01145625|P2|Participant Flow|5% MTF|"5% Minoxidil Topical Foam~5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
340271|NCT01145625|P1|Participant Flow|2% MTS|"2% Minoxidil Topical Solution~2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
340272|NCT01145625|O2|Outcome|5% MTF|"5% Minoxidil Topical Foam~5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
340273|NCT01145625|O1|Outcome|2% MTS|"2% Minoxidil Topical Solution~2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
340423|NCT01144949|O2|Outcome|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
340274|NCT01145625|O2|Outcome|5% MTF|"5% Minoxidil Topical Foam~5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
340275|NCT01145625|O1|Outcome|2% MTS|"2% Minoxidil Topical Solution~2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
340276|NCT01145625|O2|Outcome|5% MTF|"5% Minoxidil Topical Foam~5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
340277|NCT01145625|O1|Outcome|2% MTS|"2% Minoxidil Topical Solution~2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
340278|NCT01145625|E2|Reported Event|5% MTF|"5% Minoxidil Topical Foam~5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
340279|NCT01145625|E1|Reported Event|2% MTS|"2% Minoxidil Topical Solution~2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
340280|NCT01145560|B4|Baseline|Total|Total of all reporting groups
340281|NCT01145560|B3|Baseline|Placebo|Saline
340282|NCT01145560|B2|Baseline|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
340283|NCT01145560|B1|Baseline|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
340284|NCT01145560|P3|Participant Flow|Placebo|Saline
340285|NCT01145560|P2|Participant Flow|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
340286|NCT01145560|P1|Participant Flow|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
340287|NCT01145560|O3|Outcome|Placebo|Saline
340288|NCT01145560|O2|Outcome|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
340289|NCT01145560|O1|Outcome|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
340290|NCT01145560|O3|Outcome|Placebo|Saline
340291|NCT01145560|O2|Outcome|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
340292|NCT01145560|O1|Outcome|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
340293|NCT01145560|O3|Outcome|Placebo|Saline
340294|NCT01145560|O2|Outcome|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
340295|NCT01145560|O1|Outcome|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
340296|NCT01145560|O3|Outcome|Placebo|Saline
340297|NCT01145560|O2|Outcome|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
340298|NCT01145560|O1|Outcome|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
340299|NCT01145560|E3|Reported Event|Placebo|Saline
340300|NCT01145560|E2|Reported Event|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
340301|NCT01145560|E1|Reported Event|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
340302|NCT01145547|B1|Baseline|All Study Participants|"Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low Glycemic Index and in one experiment, both meals had a high Glycemic Index.~Dexcom Seven® Plus Continuous Glucose Monitoring sensor: A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject."
340303|NCT01145547|P2|Participant Flow|High Glycemic Index, Low Glycemic Index|"Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In this arm, subjects completed the first study consuming meals with high glycemic index followed by a second study consuming meals with a low glycemic index~Dexcom Seven® Plus Continuous Glucose Monitoring sensor: A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject."
340304|NCT01145547|P1|Participant Flow|Low Glycemic Index, High Glycemic Index|"Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In this arm, subjects completed the first study consuming meals with low glycemic index followed by a second study consuming meals with a high glycemic index~Dexcom Seven® Plus Continuous Glucose Monitoring sensor: A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject."
340305|NCT01145547|O2|Outcome|High Glycemic Index Effect on Post-prandial Peak|Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a high Glycemic Index.
340306|NCT01145547|O1|Outcome|Low Glycemic Index Effect on Post-prandial Peak|Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low Glycemic Index.
340307|NCT01145547|E2|Reported Event|High Glycemic Index Effect on Post-prandial Peak|Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a high Glycemic Index.
340308|NCT01145547|E1|Reported Event|Low Glycemic Index Effect on Post-prandial Peak|Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low Glycemic Index.
340309|NCT01145508|B3|Baseline|Total|Total of all reporting groups
340310|NCT01145508|B2|Baseline|Arm B (Chemotherapy)|"Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO twice daily on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~prednisone: Given PO"
340311|NCT01145508|B1|Baseline|Arm A (Vaccine and Chemotherapy)|"Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57. Beginning on day 85, patients receive chemotherapy in a 21-day cycle. Docetaxel is administered intravenously (IV) over 1 hour on day 1. Prednisone is given orally (PO) twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~PSA-TRICOM vaccine: Given SC~fowlpox-PSA-TRICOM vaccine: Given SC~docetaxel: Given IV~prednisone: Given PO"
340312|NCT01145508|P2|Participant Flow|Arm B (Chemotherapy)|"Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO twice daily on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~prednisone: Given PO"
340352|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
340313|NCT01145508|P1|Participant Flow|Arm A (Vaccine and Chemotherapy)|"Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57. Beginning on day 85, patients receive chemotherapy in a 21-day cycle. Docetaxel is administered intravenously (IV) over 1 hour on day 1. Prednisone is given orally (PO) twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~PSA-TRICOM vaccine: Given SC~fowlpox-PSA-TRICOM vaccine: Given SC~docetaxel: Given IV~prednisone: Given PO"
340314|NCT01145508|O2|Outcome|Arm B (Chemotherapy)|"Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO twice daily on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~prednisone: Given PO"
340315|NCT01145508|O1|Outcome|Arm A (Vaccine and Chemotherapy)|"Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57. Beginning on day 85, patients receive chemotherapy in a 21-day cycle. Docetaxel is administered intravenously (IV) over 1 hour on day 1. Prednisone is given orally (PO) twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~PSA-TRICOM vaccine: Given SC~fowlpox-PSA-TRICOM vaccine: Given SC~docetaxel: Given IV~prednisone: Given PO"
340316|NCT01145508|E2|Reported Event|Arm B (Chemotherapy)|"Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO twice daily on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~prednisone: Given PO"
340317|NCT01145508|E1|Reported Event|Arm A (Vaccine and Chemotherapy)|"Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57. Beginning on day 85, patients receive chemotherapy in a 21-day cycle. Docetaxel is administered intravenously (IV) over 1 hour on day 1. Prednisone is given orally (PO) twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~PSA-TRICOM vaccine: Given SC~fowlpox-PSA-TRICOM vaccine: Given SC~docetaxel: Given IV~prednisone: Given PO"
340318|NCT01145495|B1|Baseline|Treatment (Lenalidomide, Rituximab)|"Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~lenalidomide: Given orally"
340319|NCT01145495|P1|Participant Flow|Treatment (Lenalidomide, Rituximab)|"Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.~>~> rituximab: Given IV~>~> lenalidomide: Given orally"
340320|NCT01145495|O1|Outcome|Treatment (Lenalidomide, Rituximab)|"Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~lenalidomide: Given orally"
340321|NCT01145495|E1|Reported Event|Treatment (Lenalidomide, Rituximab)|lenalidomide: Given orally
340322|NCT01145482|B3|Baseline|Total|Total of all reporting groups
340323|NCT01145482|B2|Baseline|Saline First, Then Insulin|200 micro liters of saline was administered once daily on two occasions followed by 20 IU of insulin administered once daily on two occasions
340324|NCT01145482|B1|Baseline|Insulin First, Then Saline|20 IU of insulin was administered once daily on two occasions followed by 200 micro liters of saline administered once daily on two occasions
340325|NCT01145482|P2|Participant Flow|Saline First, Then Insulin|200 micro liters of saline was administered once daily on two occasions followed by 20 IU of insulin once daily on two occasions
340326|NCT01145482|P1|Participant Flow|Insulin First, Then Saline|20 IU of insulin was administered once daily on two occasions followed by 200 micro liters of saline once daily on two occasions
340327|NCT01145482|O2|Outcome|Saline|200 micro liters of saline was administered once daily on two separate occasions in either the first intervention period or second intervention period using a nasal spray bottle
340328|NCT01145482|O1|Outcome|Insulin|20 IU of insulin was administered once daily on two occasions in either the first intervention period or second intervention period using a nasal spray bottle
340329|NCT01145482|O2|Outcome|Saline|200 micro liters of saline was administered once daily on two separate occasions in either the first intervention period or second intervention period using a nasal spray bottle
340330|NCT01145482|O1|Outcome|Insulin|20 IU of insulin was administered once daily on two occasions in either the first intervention period or second intervention period using a nasal spray bottle
340331|NCT01145482|E2|Reported Event|Saline|200 micro liters of saline was administered once daily on two separate occasions in either the first intervention period or second intervention period using a nasal spray bottle
340332|NCT01145482|E1|Reported Event|Insulin|20 IU of insulin was administered once daily on two occasions in either the first intervention period or second intervention period using a nasal spray bottle
340333|NCT01145417|B3|Baseline|Total|Total of all reporting groups
340334|NCT01145417|B2|Baseline|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
340335|NCT01145417|B1|Baseline|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
340424|NCT01144949|O1|Outcome|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
340336|NCT01145417|P2|Participant Flow|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
340337|NCT01145417|P1|Participant Flow|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
340338|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
340339|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
340340|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
340341|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
340342|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
340343|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
340344|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
340345|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
340346|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
340347|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
340348|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
340349|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
340350|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
340351|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
340389|NCT01145001|B3|Baseline|Placebo Patch and Contingency Management|"Subjects in this group will receive a placebo transdermal patch and contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis"
340447|NCT01144624|P2|Participant Flow|Dose Cohort 2|AZD9773 500/100 units/kg IV
340353|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
340354|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
340355|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
340356|NCT01145417|E2|Reported Event|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
340357|NCT01145417|E1|Reported Event|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
340358|NCT01145391|B3|Baseline|Total|Total of all reporting groups
340359|NCT01145391|B2|Baseline|Intervention|An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.
340360|NCT01145391|B1|Baseline|Control|Patients receive usual care.
340361|NCT01145391|P2|Participant Flow|Intervention|An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.
340362|NCT01145391|P1|Participant Flow|Control|Patients receive usual care.
340363|NCT01145391|O2|Outcome|Intervention|An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.
340364|NCT01145391|O1|Outcome|Control|Patients receive usual care.
340365|NCT01145391|O2|Outcome|Usual Care|Usual care
340366|NCT01145391|O1|Outcome|Intervention|An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.
340367|NCT01145391|E2|Reported Event|Intervention|An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.
340368|NCT01145391|E1|Reported Event|Control|Patients receive usual care.
340369|NCT01145352|B1|Baseline|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
340370|NCT01145352|P1|Participant Flow|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
340371|NCT01145352|O1|Outcome|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
340372|NCT01145352|O1|Outcome|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
340373|NCT01145352|O1|Outcome|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
340374|NCT01145352|O1|Outcome|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
340375|NCT01145352|O1|Outcome|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
340376|NCT01145352|E1|Reported Event|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
340377|NCT01145053|B1|Baseline|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
340378|NCT01145053|P1|Participant Flow|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
340379|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
340380|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
340381|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
340382|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
340383|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
340384|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
340385|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
340386|NCT01145053|E1|Reported Event|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
340387|NCT01145001|B5|Baseline|Total|Total of all reporting groups
340388|NCT01145001|B4|Baseline|Placebo Patch and no Contingency Management|"Subjects in this group will receive a placebo patch and will not receive contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects"
340421|NCT01144949|O2|Outcome|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
340422|NCT01144949|O1|Outcome|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
340390|NCT01145001|B2|Baseline|Nicotine Patch With no Contingency Management|"Subjects in this group will receive active nicotine patch without contingency management for abstinence~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
340391|NCT01145001|B1|Baseline|Active Nicotine Patch and Contingency Management|"Subjects in this group will receive Contingency Management and active nicotine patch~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
340392|NCT01145001|P4|Participant Flow|Placebo Patch and no Contingency Management|"Subjects in this group will receive a placebo patch and will not receive contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects"
340393|NCT01145001|P3|Participant Flow|Placebo Patch and Contingency Management|"Subjects in this group will receive a placebo transdermal patch and contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis"
340394|NCT01145001|P2|Participant Flow|Nicotine Patch With no Contingency Management|"Subjects in this group will receive active nicotine patch without contingency management for abstinence~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
340395|NCT01145001|P1|Participant Flow|Active Nicotine Patch and Contingency Management|"Subjects in this group will receive Contingency Management and active nicotine patch~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
340396|NCT01145001|O4|Outcome|Placebo Patch and no Contingency Management|"Subjects in this group will receive a placebo patch and will not receive contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects"
340397|NCT01145001|O3|Outcome|Placebo Patch and Contingency Management|"Subjects in this group will receive a placebo transdermal patch and contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis"
340398|NCT01145001|O2|Outcome|Nicotine Patch With no Contingency Management|"Subjects in this group will receive active nicotine patch without contingency management for abstinence~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
340399|NCT01145001|O1|Outcome|Active Nicotine Patch and Contingency Management|"Subjects in this group will receive Contingency Management and active nicotine patch~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
340400|NCT01145001|O4|Outcome|Placebo Patch and no Contingency Management|"Subjects in this group will receive a placebo patch and will not receive contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects"
340401|NCT01145001|O3|Outcome|Placebo Patch and Contingency Management|"Subjects in this group will receive a placebo transdermal patch and contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis"
340402|NCT01145001|O2|Outcome|Nicotine Patch With no Contingency Management|"Subjects in this group will receive active nicotine patch without contingency management for abstinence~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
340403|NCT01145001|O1|Outcome|Active Nicotine Patch and Contingency Management|"Subjects in this group will receive Contingency Management and active nicotine patch~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
340404|NCT01145001|E4|Reported Event|Placebo Patch and no Contingency Management|"Subjects in this group will receive a placebo patch and will not receive contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects"
340405|NCT01145001|E3|Reported Event|Placebo Patch and Contingency Management|"Subjects in this group will receive a placebo transdermal patch and contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis"
340406|NCT01145001|E2|Reported Event|Nicotine Patch With no Contingency Management|"Subjects in this group will receive active nicotine patch without contingency management for abstinence~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
340407|NCT01145001|E1|Reported Event|Active Nicotine Patch and Contingency Management|"Subjects in this group will receive Contingency Management and active nicotine patch~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
340408|NCT01144949|B3|Baseline|Total|Total of all reporting groups
340409|NCT01144949|B2|Baseline|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
340410|NCT01144949|B1|Baseline|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
340411|NCT01144949|P2|Participant Flow|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
340412|NCT01144949|P1|Participant Flow|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
340413|NCT01144949|O2|Outcome|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
340414|NCT01144949|O1|Outcome|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
340415|NCT01144949|O2|Outcome|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
340416|NCT01144949|O1|Outcome|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
340417|NCT01144949|O2|Outcome|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
340418|NCT01144949|O1|Outcome|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
340419|NCT01144949|O2|Outcome|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
340420|NCT01144949|O1|Outcome|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
340425|NCT01144949|E2|Reported Event|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
340426|NCT01144949|E1|Reported Event|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
340427|NCT01144715|B3|Baseline|Total|Total of all reporting groups
340428|NCT01144715|B2|Baseline|Control|"Self administered home therapy program~Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
340429|NCT01144715|B1|Baseline|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks~Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
340430|NCT01144715|P2|Participant Flow|Control|"Self administered home therapy program~Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
340431|NCT01144715|P1|Participant Flow|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks~Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
340432|NCT01144715|O2|Outcome|Control|"Self administered home therapy program~Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
340433|NCT01144715|O1|Outcome|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks~Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
340434|NCT01144715|O2|Outcome|Control|"Self administered home therapy program~Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
340435|NCT01144715|O1|Outcome|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks~Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
340436|NCT01144715|O2|Outcome|Control|"Self administered home therapy program~Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
340437|NCT01144715|O1|Outcome|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks~Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
340438|NCT01144715|O2|Outcome|Control|"Self administered home therapy program~Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
340439|NCT01144715|O1|Outcome|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks~Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
340440|NCT01144715|E2|Reported Event|Control|"Self administered home therapy program~Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
340441|NCT01144715|E1|Reported Event|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks~Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
340442|NCT01144624|B4|Baseline|Total|Total of all reporting groups
340443|NCT01144624|B3|Baseline|Placebo|Saline
340444|NCT01144624|B2|Baseline|Dose Cohort 2|AZD9773 500/100 units/kg IV
340445|NCT01144624|B1|Baseline|Dose Cohort 1|AZD9773 250/50 units/kg IV
340446|NCT01144624|P3|Participant Flow|Placebo|Saline
340448|NCT01144624|P1|Participant Flow|Dose Cohort 1|AZD9773 250/50 units/kg IV
340449|NCT01144624|O3|Outcome|Arm 3 - Placebo|Saline
340450|NCT01144624|O2|Outcome|Arm 2 - Dose Cohort 2|AZD9773 500/100 units/kg IV
340451|NCT01144624|O1|Outcome|Arm 1 - Dose Cohort 1|AZD9773 250/50 units/kg IV
340452|NCT01144624|O3|Outcome|Arm 3 - Placebo|Saline
340453|NCT01144624|O2|Outcome|Arm 2 - Dose Cohort 2|AZD9773 500/100 units/kg IV
340454|NCT01144624|O1|Outcome|Arm 1 - Dose Cohort 1|AZD9773 250/50 units/kg IV
340455|NCT01144624|O3|Outcome|Arm 3 - Placebo|Saline
340456|NCT01144624|O2|Outcome|Arm 2 - Dose Cohort 2|AZD9773 500/100 units/kg IV
340457|NCT01144624|O1|Outcome|Arm 1 - Dose Cohort 1|AZD9773 250/50 units/kg IV
340458|NCT01144624|E3|Reported Event|Placebo|Saline
340459|NCT01144624|E2|Reported Event|Dose Cohort 2|AZD9773 500/100 units/kg IV
340460|NCT01144624|E1|Reported Event|Dose Cohort 1|AZD9773 250/50 units/kg IV
340461|NCT01144598|B1|Baseline|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
340462|NCT01144598|P1|Participant Flow|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
340463|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
340464|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
340465|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
340466|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
340467|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
340468|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
340469|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
340470|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
340471|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
340472|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
340473|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
340474|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
340475|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
340476|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
340477|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
340478|NCT01144598|E1|Reported Event|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
340479|NCT01144455|B4|Baseline|Total|Total of all reporting groups
340480|NCT01144455|B3|Baseline|340 mg/m2 TH-302 + Gemcitabine|"TH-302: 340 mg/m2 of TH-302 be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.~Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle~Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.~TH-302: 340 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle."
340481|NCT01144455|B2|Baseline|240 mg/m2 TH-302 + Gemcitabine|"TH-302: 240 mg/m2 administered IV over 30 minutes Day 1, 8, and 15 of each 28-day cycle~Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle~Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.~TH-302: 240 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle."
340482|NCT01144455|B1|Baseline|Gemcitabine|"Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle~Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle."
340483|NCT01144455|P3|Participant Flow|340 mg/m2 TH-302 + Gemcitabine|"TH-302: 340 mg/m2 of TH-302 be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.~Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle~Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.~TH-302: 340 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle."
340484|NCT01144455|P2|Participant Flow|240 mg/m2 TH-302 + Gemcitabine|"TH-302: 240 mg/m2 administered IV over 30 minutes Day 1, 8, and 15 of each 28-day cycle~Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle~Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.~TH-302: 240 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle."
340485|NCT01144455|P1|Participant Flow|Gemcitabine|"Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle~Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle."
340486|NCT01144455|O3|Outcome|340 mg/m2 TH-302 + Gemcitabine|"TH-302: 340 mg/m2 of TH-302 be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.~Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle~Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.~TH-302: 340 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle."
340487|NCT01144455|O2|Outcome|240 mg/m2 TH-302 + Gemcitabine|"TH-302: 240 mg/m2 administered IV over 30 minutes Day 1, 8, and 15 of each 28-day cycle~Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle~Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.~TH-302: 240 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle."
340488|NCT01144455|O1|Outcome|Gemcitabine|"Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle~Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle."
340489|NCT01144455|E3|Reported Event|340 mg/m2 TH-302 + Gemcitabine|"TH-302: 340 mg/m2 of TH-302 be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.~Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle~Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.~TH-302: 340 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle."
340490|NCT01144455|E2|Reported Event|240 mg/m2 TH-302 + Gemcitabine|"TH-302: 240 mg/m2 administered IV over 30 minutes Day 1, 8, and 15 of each 28-day cycle~Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle~Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.~TH-302: 240 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle."
340491|NCT01144455|E1|Reported Event|Gemcitabine|"Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle~Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle."
340492|NCT01144442|B1|Baseline|HIPC Treatment|Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
340493|NCT01144442|P1|Participant Flow|HIPC Treatment|Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
340494|NCT01144442|O1|Outcome|HIPC Treatment|Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
340495|NCT01144442|O1|Outcome|HIPC Treatment|Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
340496|NCT01144442|E1|Reported Event|HIPC Treatment|Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
340497|NCT01144416|B3|Baseline|Total|Total of all reporting groups
340498|NCT01144416|B2|Baseline|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
340499|NCT01144416|B1|Baseline|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
340500|NCT01144416|P2|Participant Flow|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
340501|NCT01144416|P1|Participant Flow|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recombinant follicle-stimulating hormone (recFSH) from Stimulation Days 1-7
340502|NCT01144416|O2|Outcome|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
340503|NCT01144416|O1|Outcome|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
340504|NCT01144416|O2|Outcome|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
340505|NCT01144416|O1|Outcome|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
340506|NCT01144416|O2|Outcome|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of recFSH from Stimulation Days 1-7
340507|NCT01144416|O1|Outcome|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recombinant follicle-stimulating hormone (recFSH) from Stimulation Days 1-7
340508|NCT01144416|O2|Outcome|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
340509|NCT01144416|O1|Outcome|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
340625|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
340510|NCT01144416|O2|Outcome|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
340511|NCT01144416|O1|Outcome|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
340512|NCT01144416|E4|Reported Event|Daily 300 IU recFSH -Follow-up|Participants who received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of recFSH from Stimulation Days 1-7 during Intervention Period and became pregnant.
340513|NCT01144416|E3|Reported Event|Single Injection of 150 µg SCH 900962/MK-8962-Follow-up|Participants who received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7 during Intervention Period and became pregnant.
340514|NCT01144416|E2|Reported Event|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of recFSH from Stimulation Days 1-7
340515|NCT01144416|E1|Reported Event|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
340516|NCT01144403|B1|Baseline|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with regularly prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).~Cyclophosphamide: as prescribed, 6 cycles~Fludarabine: as prescribed, 6 cycles~Mitoxantrone: as prescribed, 6 cycles~Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
340517|NCT01144403|P1|Participant Flow|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).~Cyclophosphamide: as prescribed, 6 cycles~Fludarabine: as prescribed, 6 cycles~Mitoxantrone: as prescribed, 6 cycles~Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
340518|NCT01144403|O1|Outcome|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).~Cyclophosphamide: as prescribed, 6 cycles~Fludarabine: as prescribed, 6 cycles~Mitoxantrone: as prescribed, 6 cycles~Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
340519|NCT01144403|O1|Outcome|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).~Cyclophosphamide: as prescribed, 6 cycles~Fludarabine: as prescribed, 6 cycles~Mitoxantrone: as prescribed, 6 cycles~Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
340520|NCT01144403|O1|Outcome|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).~Cyclophosphamide: as prescribed, 6 cycles~Fludarabine: as prescribed, 6 cycles~Mitoxantrone: as prescribed, 6 cycles~Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
340521|NCT01144403|O1|Outcome|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy for mantle cell lymphoma. Rituximab infusions were administered concomitantly with regularly prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).~cyclophosphamide: as prescribed, 6 cycles~fludarabine: as prescribed, 6 cycles~mitoxantrone: as prescribed, 6 cycles~rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, day 1 of each 28-day cycle, up to 8 cycles"
340522|NCT01144403|E1|Reported Event|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).~Cyclophosphamide: as prescribed, 6 cycles~Fludarabine: as prescribed, 6 cycles~Mitoxantrone: as prescribed, 6 cycles~Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
340523|NCT01144377|B6|Baseline|Total|Total of all reporting groups
340524|NCT01144377|B5|Baseline|Placebo Q2W|Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340525|NCT01144377|B4|Baseline|270 mg LY2541546 Q12W + Placebo|LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks.
340526|NCT01144377|B3|Baseline|270 mg LY2541546 Q2W|LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340527|NCT01144377|B2|Baseline|180 mg LY2541546 Q2W|LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340528|NCT01144377|B1|Baseline|180 mg LY2541546 Q4W + Placebo|LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
340529|NCT01144377|P5|Participant Flow|Placebo Q2W|Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period (for an additional 40 weeks for a total of 52 weeks follow-up for the main study participants only).
340626|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
340530|NCT01144377|P4|Participant Flow|270 mg LY2541546 Q12W + Placebo|LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
340531|NCT01144377|P3|Participant Flow|270 mg LY2541546 Q2W|LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
340532|NCT01144377|P2|Participant Flow|180 mg LY2541546 Q2W|LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
340533|NCT01144377|P1|Participant Flow|180 mg LY2541546 Q4W + Placebo|LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
340534|NCT01144377|O5|Outcome|Placebo Q2W|Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340535|NCT01144377|O4|Outcome|270 mg LY2541546 Q12W + Placebo|LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks.
340536|NCT01144377|O3|Outcome|270 mg LY2541546 Q2W|LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340537|NCT01144377|O2|Outcome|180 mg LY2541546 Q2W|LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340538|NCT01144377|O1|Outcome|180 mg LY2541546 Q4W + Placebo|LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
340539|NCT01144377|O5|Outcome|Placebo Q2W|Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340540|NCT01144377|O4|Outcome|270 mg LY2541546 Q12W + Placebo|LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks.
340541|NCT01144377|O3|Outcome|270 mg LY2541546 Q2W|LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340542|NCT01144377|O2|Outcome|180 mg LY2541546 Q2W|LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340543|NCT01144377|O1|Outcome|180 mg LY2541546 Q4W + Placebo|LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
340544|NCT01144377|O5|Outcome|Placebo Q2W|Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340545|NCT01144377|O4|Outcome|270 mg LY2541546 Q12W + Placebo|LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks.
340546|NCT01144377|O3|Outcome|270 mg LY2541546 Q2W|LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340547|NCT01144377|O2|Outcome|180 mg LY2541546 Q2W|LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340548|NCT01144377|O1|Outcome|180 mg LY2541546 Q4W + Placebo|LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
340549|NCT01144377|O5|Outcome|Placebo Q2W|Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340550|NCT01144377|O4|Outcome|270 mg LY2541546 Q12W + Placebo|LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks.
340551|NCT01144377|O3|Outcome|270 mg LY2541546 Q2W|LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340552|NCT01144377|O2|Outcome|180 mg LY2541546 Q2W|LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340553|NCT01144377|O1|Outcome|180 mg LY2541546 Q4W + Placebo|LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
340554|NCT01144377|O5|Outcome|Placebo Q2W|Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340555|NCT01144377|O4|Outcome|270 mg LY2541546 Q12W + Placebo|LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks.
340556|NCT01144377|O3|Outcome|270 mg LY2541546 Q2W|LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340557|NCT01144377|O2|Outcome|180 mg LY2541546 Q2W|LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340558|NCT01144377|O1|Outcome|180 mg LY2541546 Q4W + Placebo|LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
340559|NCT01144377|O5|Outcome|Placebo Q2W|Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340560|NCT01144377|O4|Outcome|270 mg LY2541546 Q12W + Placebo|LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks.
340561|NCT01144377|O3|Outcome|270 mg LY2541546 Q2W|LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340562|NCT01144377|O2|Outcome|180 mg LY2541546 Q2W|LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340563|NCT01144377|O1|Outcome|180 mg LY2541546 Q4W + Placebo|LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
340564|NCT01144377|O5|Outcome|Placebo Q2W|Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340565|NCT01144377|O4|Outcome|270 mg LY2541546 Q12W + Placebo|LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks.
340566|NCT01144377|O3|Outcome|270 mg LY2541546 Q2W|LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340567|NCT01144377|O2|Outcome|180 mg LY2541546 Q2W|LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340568|NCT01144377|O1|Outcome|180 mg LY2541546 Q4W + Placebo|LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
340569|NCT01144377|O5|Outcome|Placebo Q2W|Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340570|NCT01144377|O4|Outcome|270 mg LY2541546 Q12W + Placebo|LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered every 2 weeks when LY2541546 is not administered for 52 weeks.
340571|NCT01144377|O3|Outcome|270 mg LY2541546 Q2W|LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340572|NCT01144377|O2|Outcome|180 mg LY2541546 Q2W|LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340573|NCT01144377|O1|Outcome|180 mg LY2541546 Q4W + Placebo|LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered every alternate 2 weeks from the LY2541546 dose for 52 weeks.
340574|NCT01144377|E5|Reported Event|Placebo Q2W|Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340575|NCT01144377|E4|Reported Event|270 mg LY2541546 Q12W + Placebo|LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks.
340576|NCT01144377|E3|Reported Event|270 mg LY2541546 Q2W|LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340577|NCT01144377|E2|Reported Event|180 mg LY2541546 Q2W|LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
340578|NCT01144377|E1|Reported Event|180 mg LY2541546 Q4W + Placebo|LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
340579|NCT01144364|B3|Baseline|Total|Total of all reporting groups
340580|NCT01144364|B2|Baseline|Rituximab Induction, Observation Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
340581|NCT01144364|B1|Baseline|Rituximab Induction, Rituximab Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
340582|NCT01144364|P3|Participant Flow|Rituximab Induction, Observation Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
340583|NCT01144364|P2|Participant Flow|Rituximab Induction, Rituximab Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
340584|NCT01144364|P1|Participant Flow|Induction Phase-Immunochemotherapy Rituximab-FND (R-FND)|Cycles 1 to 4: Participants received rituximab: 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1*, fludarabine (F): 25 mg/m^2 IV on Days 2-4*, mitoxantrone (N): 10 mg/m^2 IV on Day 2*, dexamethasone (D) 10 mg IV (total dose) on Days 2-4*. Cycles were repeated every 28 days for a total of 4 cycles. *In Cycle 1, rituximab was given on Day 8 in order to avoid tumour lysis syndrome. Consequently, in Cycle 1, fludarabine and dexamethasone were given on Days 1, 2, and 3. Mitoxantrone was given on Day 1.
340627|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
352875|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
340585|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
340586|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
340587|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
340588|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
340589|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received either no treatment (observation) or rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
340590|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
340591|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
340592|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
340628|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
340629|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
340630|NCT01144299|E2|Reported Event|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
340631|NCT01144299|E1|Reported Event|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
340632|NCT01144286|B5|Baseline|Total|Total of all reporting groups
340593|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
340594|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
340595|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
340596|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
340597|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
340598|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|Rituximab Induction, Rituximab Maintenance Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
340599|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
340600|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
340633|NCT01144286|B4|Baseline|Arasertaconazole 600 mg|Arasertaconazole nitrate 600 mg pessary, single dose
340634|NCT01144286|B3|Baseline|Arasertaconazole Nitrate 300 mg|Arasertaconazole nitrate 300 mg pessary, single dose
340635|NCT01144286|B2|Baseline|Arasertaconazole Nitrate 150 mg|Arasertaconazole nitrate 150 mg pessary, single dose
340601|NCT01144364|O1|Outcome|Rituximab Induction|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received either no therapy (observation) or rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
340602|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
340603|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
340604|NCT01144364|E3|Reported Event|Rituximab Induction, Observation Maintenance (Follow-up Phase)|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
340605|NCT01144364|E2|Reported Event|Rituximab Induction, Rituximab Maintenance (Follow-up Phase)|Rituximab Induction, Rituximab Maintenance Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
340606|NCT01144364|E1|Reported Event|Rituximab Induction (Induction Phase Only)|Rituximab Induction, Rituximab Maintenance Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).
340607|NCT01144299|B3|Baseline|Total|Total of all reporting groups
340608|NCT01144299|B2|Baseline|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
340609|NCT01144299|B1|Baseline|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
340610|NCT01144299|P2|Participant Flow|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
340611|NCT01144299|P1|Participant Flow|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
340612|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
340613|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
340614|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
340615|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
340616|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
340617|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
340618|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
340619|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
340620|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
340621|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
340622|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
340623|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
340624|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
340637|NCT01144286|P4|Participant Flow|Arasertaconazole 600 mg|Arasertaconazole nitrate 600 mg pessary, single dose
340638|NCT01144286|P3|Participant Flow|Arasertaconazole Nitrate 300 mg|Arasertaconazole nitrate 300 mg pessary, single dose
340639|NCT01144286|P2|Participant Flow|Arasertaconazole Nitrate 150 mg|Arasertaconazole nitrate 150 mg pessary, single dose
340640|NCT01144286|P1|Participant Flow|Placebo|placebo pessary, single dose
340641|NCT01144286|O4|Outcome|Arasertaconazole 600 mg|Arasertaconazole nitrate 600 mg pessary, single dose
340642|NCT01144286|O3|Outcome|Arasertaconazole Nitrate 300 mg|Arasertaconazole nitrate 300 mg pessary, single dose
340643|NCT01144286|O2|Outcome|Arasertaconazole Nitrate 150 mg|Arasertaconazole nitrate 150 mg pessary, single dose
340644|NCT01144286|O1|Outcome|Placebo|placebo pessary, single dose
340645|NCT01144286|O4|Outcome|Arasertaconazole 600 mg|Arasertaconazole nitrate 600 mg pessary, single dose
340646|NCT01144286|O3|Outcome|Arasertaconazole Nitrate 300 mg|Arasertaconazole nitrate 300 mg pessary, single dose
340647|NCT01144286|O2|Outcome|Arasertaconazole Nitrate 150 mg|Arasertaconazole nitrate 150 mg pessary, single dose
340648|NCT01144286|O1|Outcome|Placebo|placebo pessary, single dose
340649|NCT01144286|E4|Reported Event|Arasertaconazole 600 mg|Arasertaconazole nitrate 600 mg pessary, single dose
340650|NCT01144286|E3|Reported Event|Arasertaconazole Nitrate 300 mg|Arasertaconazole nitrate 300 mg pessary, single dose
340651|NCT01144286|E2|Reported Event|Arasertaconazole Nitrate 150 mg|Arasertaconazole nitrate 150 mg pessary, single dose
340652|NCT01144286|E1|Reported Event|Placebo|placebo pessary, single dose
340653|NCT01144182|B3|Baseline|Total|Total of all reporting groups
340654|NCT01144182|B2|Baseline|Comprehensive Quality Improvement Program (QIP)|Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients.
340655|NCT01144182|B1|Baseline|Current Best Practice (CBP)|Current best practice (CBP) receives the current treatment for patients discharged with heart failure
340656|NCT01144182|P2|Participant Flow|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
340657|NCT01144182|P1|Participant Flow|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
340658|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
340659|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
340660|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
340661|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
340662|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
340663|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
340664|NCT01144182|O2|Outcome|Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
340665|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
340666|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
352876|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
340667|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
340668|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
340669|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
340670|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
340671|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
340672|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
340673|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
340674|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
340675|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
340676|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
340677|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
340678|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
340679|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
340680|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
340681|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
340682|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
340683|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
340684|NCT01144182|E2|Reported Event|Quality Improvement Program (QIP)|"Quality improvement program (QIP)~The comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
340685|NCT01144182|E1|Reported Event|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
340686|NCT01144143|B4|Baseline|Total|Total of all reporting groups
341384|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
340687|NCT01144143|B3|Baseline|Methylprednisolone Acetate|Methylprednisolone Acetate (Standard of Care: MPA) – Standard of Care: MPA 80mg injected into the joint through a needle
340688|NCT01144143|B2|Baseline|Salt Water|Placebo (Salt Water) – 10 ml Placebo solution will be injected into the joint through a needle
340689|NCT01144143|B1|Baseline|Infliximab|Investigational (Infliximab) – 100mg The study drug will be injected into the joint through a needle
340690|NCT01144143|P3|Participant Flow|Methylprednisolone Acetate|Methylprednisolone Acetate (Standard of Care: MPA) – Standard of Care: MPA 80mg injected into the joint through a needle
340691|NCT01144143|P2|Participant Flow|Salt Water|Placebo (Salt Water) – 10 ml Placebo solution will be injected into the joint through a needle
340692|NCT01144143|P1|Participant Flow|Infliximab|Investigational (Infliximab) – 100mg The study drug will be injected into the joint through a needle
340693|NCT01144143|O3|Outcome|Methylprednisolone Acetate|Methylprednisolone Acetate (Standard of Care: MPA) – Standard of Care: MPA 80mg injected into the joint through a needle
340694|NCT01144143|O2|Outcome|Salt Water|Placebo (Salt Water) – 10 ml Placebo solution will be injected into the joint through a needle
340695|NCT01144143|O1|Outcome|Infliximab|Investigational (Infliximab) – 100mg The study drug will be injected into the joint through a needle
340696|NCT01144143|O3|Outcome|Methylprednisolone Acetate|Methylprednisolone Acetate (Standard of Care: MPA) – Standard of Care: MPA 80mg injected into the joint through a needle
340697|NCT01144143|O2|Outcome|Salt Water|Placebo (Salt Water) – 10 ml Placebo solution will be injected into the joint through a needle
340698|NCT01144143|O1|Outcome|Infliximab|Investigational (Infliximab) – 100mg The study drug will be injected into the joint through a needle
340699|NCT01144143|O3|Outcome|Methylprednisolone Acetate|Methylprednisolone Acetate (Standard of Care: MPA) – Standard of Care: MPA 80mg injected into the joint through a needle
340700|NCT01144143|O2|Outcome|Salt Water|Placebo (Salt Water) – 10 ml Placebo solution will be injected into the joint through a needle
340701|NCT01144143|O1|Outcome|Infliximab|Investigational (Infliximab) – 100mg The study drug will be injected into the joint through a needle
340702|NCT01144143|O3|Outcome|Methylprednisolone Acetate|Standard of Care: Methylprednisolone acetate: Methylprednisolone acetate will be injected into the joint through a needle
340703|NCT01144143|O2|Outcome|Normal Saline|Placebo: the placebo will be injected into the joint through a needle
340704|NCT01144143|O1|Outcome|Infliximab|Infliximab: the study drug will be injected into the joint through a needle
340705|NCT01144143|O3|Outcome|Methylprednisolone Acetate|Methylprednisolone Acetate (Standard of Care: MPA) – Standard of Care: MPA 80mg injected into the joint through a needle
340706|NCT01144143|O2|Outcome|Salt Water|Placebo (Salt Water) – 10 ml Placebo solution will be injected into the joint through a needlePlacebo: the placebo will be injected into the joint through a needle
340707|NCT01144143|O1|Outcome|Infliximab|Investigational (Infliximab) – 100mg The study drug will be injected into the joint through a needle
340708|NCT01144143|O3|Outcome|Methylprednisolone Acetate|Methylprednisolone Acetate (Standard of Care: MPA) – Standard of Care: MPA 80mg injected into the joint through a needle
340709|NCT01144143|O2|Outcome|Salt Water|Placebo (Salt Water) – 10 ml Placebo solution will be injected into the joint through a needle
340710|NCT01144143|O1|Outcome|Infliximab|Investigational (Infliximab) – 100mg The study drug will be injected into the joint through a needle
340711|NCT01144143|E3|Reported Event|Methylprednisolone Acetate|Methylprednisolone Acetate (Standard of Care: MPA) – Standard of Care: MPA 80mg injected into the joint through a needle
340712|NCT01144143|E2|Reported Event|Salt Water|Placebo (Salt Water) – 10 ml Placebo solution will be injected into the joint through a needle
340713|NCT01144143|E1|Reported Event|Infliximab|Investigational (Infliximab) – 100mg The study drug will be injected into the joint through a needle
340714|NCT01144052|B3|Baseline|Total|Total of all reporting groups
340715|NCT01144052|B2|Baseline|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
340716|NCT01144052|B1|Baseline|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions.
340717|NCT01144052|P2|Participant Flow|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
340718|NCT01144052|P1|Participant Flow|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions.
340719|NCT01144052|O2|Outcome|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
340720|NCT01144052|O1|Outcome|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
340721|NCT01144052|O2|Outcome|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
340722|NCT01144052|O1|Outcome|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
340723|NCT01144052|O2|Outcome|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
340724|NCT01144052|O1|Outcome|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
340800|NCT01143792|P1|Participant Flow|CRA + HIV Prevention|Description of CRA: Treatment included twelve 1-hour sessions in addition to two HIV prevention sessions.
340801|NCT01143792|O3|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
340725|NCT01144052|O2|Outcome|Interferon-beta-1b|"250 mcg (8 MIU) subcutaneous injections every other day~interferon beta-1b: Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 month at study entry. After a wash-out period of one month, interferon-beta-1b will be administered subcutaneously every other day as indicated by the manufacturers' instructions including the stepwise up-titration scheme as recommended for treatment start. The final dose of interferon beta-1b is 250 mcg (8 million International Units [MIU])"
340726|NCT01144052|O1|Outcome|Natalizumab|"Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions.~Natalizumab: Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions."
340727|NCT01144052|O2|Outcome|Interferon-beta-1b|"250 mcg (8 MIU) subcutaneous injections every other day~interferon beta-1b: Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 month at study entry. After a wash-out period of one month, interferon-beta-1b will be administered subcutaneously every other day as indicated by the manufacturers' instructions including the stepwise up-titration scheme as recommended for treatment start. The final dose of interferon beta-1b is 250 mcg (8 million International Units [MIU])"
340728|NCT01144052|O1|Outcome|Natalizumab|"Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions.~Natalizumab: Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions."
340729|NCT01144052|O2|Outcome|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
340730|NCT01144052|O1|Outcome|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
340731|NCT01144052|O2|Outcome|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
340732|NCT01144052|O1|Outcome|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
340733|NCT01144052|O2|Outcome|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
340734|NCT01144052|O1|Outcome|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
340735|NCT01144052|E2|Reported Event|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
340736|NCT01144052|E1|Reported Event|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions.
340737|NCT01144026|B3|Baseline|Total|Total of all reporting groups
340738|NCT01144026|B2|Baseline|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
340739|NCT01144026|B1|Baseline|TUTI-16 (0.2mg)|Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
340740|NCT01144026|P2|Participant Flow|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
340741|NCT01144026|P1|Participant Flow|TUTI-16 (0.2mg)|Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
340742|NCT01144026|O2|Outcome|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
340743|NCT01144026|O1|Outcome|TUTI-16 (0.2mg)|Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
340744|NCT01144026|E2|Reported Event|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
340745|NCT01144026|E1|Reported Event|TUTI-16 (0.2mg)|Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
340746|NCT01143896|B3|Baseline|Total|Total of all reporting groups
340747|NCT01143896|B2|Baseline|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
340748|NCT01143896|B1|Baseline|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
340749|NCT01143896|P2|Participant Flow|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
340802|NCT01143792|O2|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
340803|NCT01143792|O1|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
341154|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
340750|NCT01143896|P1|Participant Flow|Arm 1: Depression Collaborative Care|Depression collaborative care model: The depression collaborative care arm will include a stepped-care model. The five steps are expected to include symptom and self-management monitoring by depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM will provide education about depression and depression treatment options, assess the patient's treatment preferences and barriers, assess the patient's current depression severity and mental health comorbidity, initiate a self-management plan, and assess treatment adherence. The DCM will use the alcohol screening and brief intervention. The DCM will also screen for street drug use and will recommend referral of participants who are using street drugs to the local substance abuse treatment programs.
340751|NCT01143896|O2|Outcome|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
340752|NCT01143896|O1|Outcome|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
340753|NCT01143896|O2|Outcome|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
340754|NCT01143896|O1|Outcome|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
340755|NCT01143896|O2|Outcome|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
340756|NCT01143896|O1|Outcome|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
340757|NCT01143896|O2|Outcome|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
340758|NCT01143896|O1|Outcome|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
340759|NCT01143896|O2|Outcome|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
340760|NCT01143896|O1|Outcome|Arm 1: Depression Collaborative Care|Depression collaborative care model: The depression collaborative care arm will include a stepped-care model. The five steps are expected to include symptom and self-management monitoring by depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM will provide education about depression and depression treatment options, assess the patient's treatment preferences and barriers, assess the patient's current depression severity and mental health comorbidity, initiate a self-management plan, and assess treatment adherence. The DCM will use the alcohol screening and brief intervention. The DCM will also screen for street drug use and will recommend referral of participants who are using street drugs to the local substance abuse treatment programs.
340761|NCT01143896|O2|Outcome|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
340804|NCT01143792|O3|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
341385|NCT01142193|O2|Outcome|Placebo|Placebo
340762|NCT01143896|O1|Outcome|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
340763|NCT01143896|E2|Reported Event|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
340764|NCT01143896|E1|Reported Event|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
340765|NCT01143883|B3|Baseline|Total|Total of all reporting groups
340766|NCT01143883|B2|Baseline|Standard of Care Dressing|55
340767|NCT01143883|B1|Baseline|Silverlon Dressing|55
340768|NCT01143883|P2|Participant Flow|Standard of Care Dressing|The standard plain gauze is used to dress the wound postoperatively
340769|NCT01143883|P1|Participant Flow|Silverlon Dressing|The Silverlon(Cura Surgical, Geneva, IL) dressing is applied to the surgical wound postoperatively. This dressing is coated with silver nylon.
340770|NCT01143883|O2|Outcome|Standard of Care Dressing|55
340771|NCT01143883|O1|Outcome|Silverlon Dressing|55
340772|NCT01143883|E2|Reported Event|Standard of Care Dressing|55
340773|NCT01143883|E1|Reported Event|Silverlon Dressing|55
340774|NCT01143870|B4|Baseline|Total|Total of all reporting groups
340775|NCT01143870|B3|Baseline|Faces|Received information on diabetes control translated into a emoticon, ranging from smiling to crying
340776|NCT01143870|B2|Baseline|Letter Grades|Received information on diabetes control translated into a letter grade, ranging from A-F
340777|NCT01143870|B1|Baseline|Control|Received information on diabetes control using the standard hemoglobin A1c value
340778|NCT01143870|P3|Participant Flow|Faces|Received information on diabetes control translated into a emoticon, ranging from smiling to crying
340779|NCT01143870|P2|Participant Flow|Letter Grades|Received information on diabetes control translated into a letter grade, ranging from A-F
340780|NCT01143870|P1|Participant Flow|Control|Received information on diabetes control using the standard hemoglobin A1c value
340781|NCT01143870|O3|Outcome|Faces|Received information on diabetes control translated into a emoticon, ranging from smiling to crying
340782|NCT01143870|O2|Outcome|Letter Grades|Received information on diabetes control translated into a letter grade, ranging from A-F
340783|NCT01143870|O1|Outcome|Control|Received information on diabetes control using the standard hemoglobin A1c value
340784|NCT01143870|E3|Reported Event|Faces|
340785|NCT01143870|E2|Reported Event|Letter Grades|
340786|NCT01143870|E1|Reported Event|Control|Received information on diabetes control using the standard hemoglobin A1c value
340787|NCT01143818|B1|Baseline|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
340788|NCT01143818|P1|Participant Flow|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
340789|NCT01143818|O1|Outcome|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
340790|NCT01143818|O1|Outcome|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
340791|NCT01143818|O1|Outcome|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
340792|NCT01143818|O1|Outcome|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
340793|NCT01143818|E1|Reported Event|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
340794|NCT01143792|B4|Baseline|Total|Total of all reporting groups
340795|NCT01143792|B3|Baseline|Case Management + HIV Prevention|Treatment included twelve 1-hour sessions for a total of 14 sessions.
340796|NCT01143792|B2|Baseline|MET + HIV Prevention|Treatment included two 1-hour MI sessions for a total of 4 sessions
340797|NCT01143792|B1|Baseline|CRA + HIV Prevention|Treatment included twelve 1-hour sessions for a total of 14 sessions.
340798|NCT01143792|P3|Participant Flow|Case Management + HIV Prevention|Description of CM: Treatment included twelve 1-hour sessions in addition to two HIV prevention sessions.
340799|NCT01143792|P2|Participant Flow|MET + HIV Prevention|Description of MET: Treatment included two 1-hour sessions in addition to two HIV prevention sessions.
352877|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
340805|NCT01143792|O2|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
340806|NCT01143792|O1|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
340807|NCT01143792|O3|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
340808|NCT01143792|O2|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
340809|NCT01143792|O1|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
340810|NCT01143792|O3|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
340811|NCT01143792|O2|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
340812|NCT01143792|O1|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
340813|NCT01143792|O3|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
340814|NCT01143792|O2|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
340815|NCT01143792|O1|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
340816|NCT01143792|O3|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
340817|NCT01143792|O2|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
340818|NCT01143792|O1|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
340819|NCT01143792|O3|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
340820|NCT01143792|O2|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
340821|NCT01143792|O1|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
340822|NCT01143792|O3|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
340823|NCT01143792|O2|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
340824|NCT01143792|O1|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
340825|NCT01143792|O3|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
340826|NCT01143792|O2|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. the groups equally.
340827|NCT01143792|O1|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
340828|NCT01143792|E3|Reported Event|Case Management + HIV Prevention|Treatment included twelve 1-hour sessions for a total of 14 sessions.
340829|NCT01143792|E2|Reported Event|MET + HIV Prevention|Treatment included two 1-hour MI sessions for a total of 4 sessions
340830|NCT01143792|E1|Reported Event|CRA + HIV Prevention|Treatment included twelve 1-hour sessions for a total of 14 sessions.
340831|NCT01143766|B3|Baseline|Total|Total of all reporting groups
340832|NCT01143766|B2|Baseline|Gapabentin|Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.
340833|NCT01143766|B1|Baseline|Standard Sedation|Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
340834|NCT01143766|P2|Participant Flow|Gapabentin|Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.
340835|NCT01143766|P1|Participant Flow|Standard Sedation|Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
352878|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
340836|NCT01143766|O2|Outcome|Gapabentin|Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.
340837|NCT01143766|O1|Outcome|Standard Sedation|Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
340838|NCT01143766|O2|Outcome|Gapabentin|Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.
340839|NCT01143766|O1|Outcome|Standard Sedation|Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
340840|NCT01143766|O2|Outcome|Gapabentin|Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.
340841|NCT01143766|O1|Outcome|Standard Sedation|Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
340842|NCT01143766|O2|Outcome|Gapabentin|"Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.~Gabapentin: gabapentin 900mg PO x 1 dose, 1 hour prior to the procedure"
340843|NCT01143766|O1|Outcome|Standard Sedation|"Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.~Standard sedation regimen: Combination opiate and benzodiazepine will be administered to achieve moderate sedation. This is the standard of care."
340844|NCT01143766|O2|Outcome|Gapabentin|Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.
340845|NCT01143766|O1|Outcome|Standard Sedation|Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
340846|NCT01143766|E2|Reported Event|Gapabentin|Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.
340847|NCT01143766|E1|Reported Event|Standard Sedation|Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
340848|NCT01143727|B3|Baseline|Total|Total of all reporting groups
340849|NCT01143727|B2|Baseline|Control|"Tegaderm Hydrogel~Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound."
340850|NCT01143727|B1|Baseline|Collagenase Santyl Ointment|"Santyl~Santyl : Applied once every 24-hr period sufficient to cover the wound."
340851|NCT01143727|P2|Participant Flow|Control|"Tegaderm Hydrogel~Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound."
340852|NCT01143727|P1|Participant Flow|Collagenase Santyl Ointment|"Santyl~Santyl : Applied once every 24-hr period sufficient to cover the wound."
340853|NCT01143727|O2|Outcome|Control|"Tegaderm Hydrogel~Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound."
340854|NCT01143727|O1|Outcome|Collagenase Santyl Ointment|"Santyl~Santyl : Applied once every 24-hr period sufficient to cover the wound."
340855|NCT01143727|O2|Outcome|Control|"Tegaderm Hydrogel~Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound."
340856|NCT01143727|O1|Outcome|Collagenase Santyl Ointment|"Santyl~Santyl : Applied once every 24-hr period sufficient to cover the wound."
340857|NCT01143727|E2|Reported Event|Control|"Tegaderm Hydrogel~Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound."
340858|NCT01143727|E1|Reported Event|Collagenase Santyl Ointment|"Santyl~Santyl : Applied once every 24-hr period sufficient to cover the wound."
340859|NCT01143714|B3|Baseline|Total|Total of all reporting groups
340860|NCT01143714|B2|Baseline|Vehicle (White Petrolatum)|White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
340861|NCT01143714|B1|Baseline|Collagenase Santyl Ointment|Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
340862|NCT01143714|P2|Participant Flow|Vehicle (White Petrolatum)|White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
340863|NCT01143714|P1|Participant Flow|Collagenase Santyl Ointment|Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
340864|NCT01143714|O2|Outcome|Vehicle (White Petrolatum)|White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
340865|NCT01143714|O1|Outcome|Collagenase Santyl Ointment|Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
340866|NCT01143714|O2|Outcome|Vehicle (White Petrolatum)|White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
340867|NCT01143714|O1|Outcome|Collagenase Santyl Ointment|Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
340868|NCT01143714|E2|Reported Event|Vehicle (White Petrolatum)|White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
340869|NCT01143714|E1|Reported Event|Collagenase Santyl Ointment|Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
340870|NCT01143701|B3|Baseline|Total|Total of all reporting groups
340871|NCT01143701|B2|Baseline|Typical ADHD Care|Physicians in this group will provide typical ADHD care.
340872|NCT01143701|B1|Baseline|ADHD Collaborative Intervention|"The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.~ADHD Collaborative: The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines."
340873|NCT01143701|P2|Participant Flow|Typical ADHD Care|Physicians in this group will provide typical ADHD care.
340874|NCT01143701|P1|Participant Flow|ADHD Collaborative Intervention|"The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.~ADHD Collaborative: The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics ADHD guidelines."
340875|NCT01143701|O2|Outcome|Typical ADHD Care|Physicians in this group will provide typical ADHD care.
340876|NCT01143701|O1|Outcome|ADHD Collaborative Intervention|"The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.~ADHD Collaborative: The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines."
340877|NCT01143701|O2|Outcome|Typical ADHD Care|Physicians in this group will provide typical ADHD care.
340878|NCT01143701|O1|Outcome|ADHD Collaborative Intervention|"The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.~ADHD Collaborative: The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines."
340879|NCT01143701|E2|Reported Event|Typical ADHD Care|Physicians in this group will provide typical ADHD care.
340880|NCT01143701|E1|Reported Event|ADHD Collaborative Intervention|"The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.~ADHD Collaborative: The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines."
340881|NCT01143688|B1|Baseline|Overall Study|
340882|NCT01143688|P1|Participant Flow|All Study Participants|Each study participant was randomized to a specific random sequence of interventions for visits 1-4 (e.g. first inhaled bronchodilator, then inhaled placebo, then sham acupuncture, then no intervention administered 3-7 days apart, or first sham acupuncture, then inhaled bronchodilator, then no intervention, then inhaled placebo administered 3-7 days apart, or any other combination of these four interventions in any order). This process was repeated for visits 5-8 and again for visits 9-12.
340883|NCT01143688|O4|Outcome|No-intervention Control|"Subjects will be instructed that they will receive no interventions on this visit.~Spirometry will be obtained every 20 minutes for maximal FEV1 for 120 minutes. In the time period between spirometry, subjects will sit quietly in a separate waiting area."
340884|NCT01143688|O3|Outcome|Placebo Acupuncture|Subjects will be instructed that they will receive one of three different acupuncture point combinations that may or may not be effective for asthma. Placebo acupuncture will be performed with a validated acupuncture device that allows patients to see an acupuncture needle enter their skin and actually feel the sensation of penetration. The needle penetrates up the needle shaft and never penetrates the point. The needle has been validated and shown to be indistinguishable from real acupuncture.
340885|NCT01143688|O2|Outcome|Placebo Inhaler|Subjects will be shown an unmarked metered-dose inhaler similar to that used for bronchodilator testing. This placebo inhaler contains only propellant and inert ingredients (trichlorofluoromethane and dichlorodifluoromethane with lecithin). The subjects will be reminded that this inhaler may contain either albuterol or placebo. They will then inhale 4 puffs of the placebo inhaler containing only the propellant vehicle through a spacer. Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area.
340886|NCT01143688|O1|Outcome|Albuterol Inhaler|"Subjects will perform baseline spirometry. Subsequently subjects will be shown an unmarked metered-dose inhaler device. This inhaler contains active albuterol (90 mcg/puff). The subjects will be reminded that this inhaler may contain either albuterol or placebo, and will complete questionnaires documenting their expectations for improvement in lung function with this treatment. Subsequently subjects will inhale 4 puffs (360 mcg) of albuterol administered from this inhaler via a spacing device.~Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area."
340887|NCT01143688|O4|Outcome|No-intervention Control|"Subjects will be instructed that they will receive no interventions on this visit.~Spirometry will be obtained every 20 minutes for maximal FEV1 for 120 minutes. In the time period between spirometry, subjects will sit quietly in a separate waiting area."
340888|NCT01143688|O3|Outcome|Placebo Acupuncture|Subjects will be instructed that they will receive one of three different acupuncture point combinations that may or may not be effective for asthma. Placebo acupuncture will be performed with a validated acupuncture device that allows patients to see an acupuncture needle enter their skin and actually feel the sensation of penetration. The needle penetrates up the needle shaft and never penetrates the point. The needle has been validated and shown to be indistinguishable from real acupuncture.
340889|NCT01143688|O2|Outcome|Placebo Inhaler|Subjects will be shown an unmarked metered-dose inhaler similar to that used for bronchodilator testing. This placebo inhaler contains only propellant and inert ingredients (trichlorofluoromethane and dichlorodifluoromethane with lecithin). The subjects will be reminded that this inhaler may contain either albuterol or placebo. They will then inhale 4 puffs of the placebo inhaler containing only the propellant vehicle through a spacer. Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area.
341030|NCT01143272|P2|Participant Flow|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
340890|NCT01143688|O1|Outcome|Albuterol Inhaler|"Subjects will perform baseline spirometry. Subsequently subjects will be shown an unmarked metered-dose inhaler device. This inhaler contains active albuterol (90 mcg/puff). The subjects will be reminded that this inhaler may contain either albuterol or placebo, and will complete questionnaires documenting their expectations for improvement in lung function with this treatment. Subsequently subjects will inhale 4 puffs (360 mcg) of albuterol administered from this inhaler via a spacing device.~Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area."
340891|NCT01143688|E4|Reported Event|No-intervention Control|"Subjects will be instructed that they will receive no interventions on this visit.~Spirometry will be obtained every 20 minutes for maximal FEV1 for 120 minutes. In the time period between spirometry, subjects will sit quietly in a separate waiting area."
340892|NCT01143688|E3|Reported Event|Placebo Acupuncture|Subjects will be instructed that they will receive one of three different acupuncture point combinations that may or may not be effective for asthma. Placebo acupuncture will be performed with a validated acupuncture device that allows patients to see an acupuncture needle enter their skin and actually feel the sensation of penetration. The needle penetrates up the needle shaft and never penetrates the point. The needle has been validated and shown to be indistinguishable from real acupuncture.
340893|NCT01143688|E2|Reported Event|Placebo Inhaler|Subjects will be shown an unmarked metered-dose inhaler similar to that used for bronchodilator testing. This placebo inhaler contains only propellant and inert ingredients (trichlorofluoromethane and dichlorodifluoromethane with lecithin). The subjects will be reminded that this inhaler may contain either albuterol or placebo. They will then inhale 4 puffs of the placebo inhaler containing only the propellant vehicle through a spacer. Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area.
340894|NCT01143688|E1|Reported Event|Albuterol Inhaler|"Subjects will perform baseline spirometry. Subsequently subjects will be shown an unmarked metered-dose inhaler device. This inhaler contains active albuterol (90 mcg/puff). The subjects will be reminded that this inhaler may contain either albuterol or placebo, and will complete questionnaires documenting their expectations for improvement in lung function with this treatment. Subsequently subjects will inhale 4 puffs (360 mcg) of albuterol administered from this inhaler via a spacing device.~Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area."
340895|NCT01143649|B6|Baseline|Total|Total of all reporting groups
340896|NCT01143649|B5|Baseline|tACS Active&Sham - Healthy|active or sham 15Hz-tACS over of the primary motor cortex (M1) bilaterally.
340897|NCT01143649|B4|Baseline|Sham tDCS + CIMT - Healthy|Participants received sham tDCS (1mA - 40min) of the primary motor cortex (M1) bilaterally combined with unilateral motor training and contralateral hand restraint.
340898|NCT01143649|B3|Baseline|tDCS Active + CIMT - Healthy|Participants received active (1mA - 40min) of the primary motor cortex (M1) bilaterally combined with unilateral motor training and contralateral hand restraint.
340899|NCT01143649|B2|Baseline|Sham tDCS + CIMT - Stroke|Participants received sham tDCS over the primary motor cortex plus CIMT. The same site and parameters of stimulation were employed, but the stimulator was turned off after 30 seconds of stimulation. This ensured that patients could feel the initial itching sensation at the beginning of tDCS.
340900|NCT01143649|B1|Baseline|tDCS + CIMT - Stroke|"Participants received active tDCS over the primary motor cortex (M1). We used the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday).~Transcranial Stimulation: Subjects were stimulated at 1 mA for 40 minutes."
340901|NCT01143649|P6|Participant Flow|Healthy Participants - Sham tACS, Then Active|Subjects will receive 20 min of sham and then tACS over the primary motor cortex in a randomized order.
340902|NCT01143649|P5|Participant Flow|Healthy Participants - Active tACS, Then Sham|Subjects will receive 20 min of active then sham tACS over the primary motor cortex in a randomized order.
340903|NCT01143649|P4|Participant Flow|Healthy Participants: Sham tDCS + Motor Training|"Each stimulation day will include up to six hours of training termed shaping in the non-dominant hand while the dominant hand is restrained in a resting hand splint and secured in a sling. At the start of this training, subjects will undergo 40 minutes of sham tDCS."
340904|NCT01143649|P3|Participant Flow|Healthy Participants: Active tDCS + Motor Training|"Each stimulation day will include up to six hours of training termed shaping in the non-dominant hand while the dominant hand is restrained in a resting hand splint and secured in a sling. At the start of this training, subjects will undergo 40 minutes of tDCS at 1mA."
340905|NCT01143649|P2|Participant Flow|Sham tDCS + CIMT - Stroke|"Participants will receive tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday).~Sham stimulation consists of 30secondes of stimulation at the beginning of the 40minutes treatment."
340906|NCT01143649|P1|Participant Flow|tDCS + CIMT - Stroke|"Participants will receive tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday).~Transcranial Stimulation: Subjects will be stimulated at 1 mA for 40 minutes."
340907|NCT01143649|O2|Outcome|Healthy Participants - Sham tACS|Subjects will receive 20 min of sham tACS
340908|NCT01143649|O1|Outcome|Healthy Participants - Active tACS|Subjects will receive 20 min of active tACS
340909|NCT01143649|O2|Outcome|Healthy Participants: Sham tDCS + Motor Training|"Each stimulation day will include up to six hours of training termed shaping in the non-dominant hand while the dominant hand is restrained in a resting hand splint and secured in a sling. At the start of this training, subjects will undergo 40 minutes of sham tDCS."
341056|NCT01143259|O1|Outcome|300 mg Polyethylene|Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
340910|NCT01143649|O1|Outcome|Healthy Participants: Active tDCS + Motor Training|"Each stimulation day will include up to six hours of training termed shaping in the non-dominant hand while the dominant hand is restrained in a resting hand splint and secured in a sling. At the start of this training, subjects will undergo 40 minutes of tDCS at 1mA."
340911|NCT01143649|O2|Outcome|Sham tDCS + CIMT|Participants received sham tDCS over the primary motor cortex plus CIMT. The same site and parameters of stimulation were employed, but the stimulator was turned off after 30 seconds of stimulation. This ensured that patients could feel the initial itching sensation at the beginning of tDCS.
340912|NCT01143649|O1|Outcome|tDCS + CIMT|"Participants will receive tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday).~Transcranial Stimulation: Subjects will be stimulated at 1 mA for 40 minutes."
340913|NCT01143649|E6|Reported Event|Sham tACS - Healthy|Subjects will undergo 20 minutes of sham tACS.
340914|NCT01143649|E5|Reported Event|Active tACS - Healthy|Subjects will undergo 20 minutes of active tACS.
340915|NCT01143649|E4|Reported Event|Sham tDCS + CIMT - Healthy|subjects will undergo 40 minutes of sham tDCS.
340916|NCT01143649|E3|Reported Event|Active tDCS + CIMT - Healthy|subjects will undergo 40 minutes of tDCS at 1mA.
340917|NCT01143649|E2|Reported Event|Sham tDCS + CIMT - Stroke|Participants received sham tDCS over the primary motor cortex plus CIMT. The same site and parameters of stimulation were employed, but the stimulator was turned off after 30 seconds of stimulation. This ensured that patients could feel the initial itching sensation at the beginning of tDCS.
340918|NCT01143649|E1|Reported Event|tDCS + CIMT - Stroke|"Participants will receive tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday).~Transcranial Stimulation: Subjects will be stimulated at 1 mA for 40 minutes."
340919|NCT01143636|B4|Baseline|Total|Total of all reporting groups
340920|NCT01143636|B3|Baseline|Active tDCS&Sham tDCS - Healthy Controls|Healthy Controls: These subjects received one single session of active tDCS and one one single session of sham tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received active stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.
340921|NCT01143636|B2|Baseline|Sham tDCS - Pelvic Pain|Sham Comparator: Subjects received a total of 10 consecutive sessions of sham tDCS over a two-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
340922|NCT01143636|B1|Baseline|Active tDCS - Pelvic Pain|Experimental Group: Subjects received a total of 10 consecutive sessions of active tDCS over a two-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
340923|NCT01143636|P4|Participant Flow|Healthy Subjects: Sham tDCS/Active tDCS|Healthy Controls: These subjects received one single session of sham tDCS and one single session of active tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received sham stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.
340924|NCT01143636|P3|Participant Flow|Healthy Controls: Active tDCS/Sham tDCS|Healthy Controls: These subjects received one single session of active tDCS and one one single session of sham tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received active stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.
340925|NCT01143636|P2|Participant Flow|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 10 consecutive sessions of sham tDCS over a two-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
340926|NCT01143636|P1|Participant Flow|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 10 consecutive sessions of active tDCS over a two-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
340927|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
340928|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
340929|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
340930|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
340931|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
340932|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
340933|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
340934|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
340935|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
340936|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
340937|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
340938|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
340939|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
340940|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
340941|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
340942|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
340943|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
340944|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
340945|NCT01143636|O2|Outcome|Healthy Subjects: Sham tDCS|Healthy Controls: These subjects received one single session of sham tDCS and one single session of active tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received sham stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.
340946|NCT01143636|O1|Outcome|Healthy Controls: Active tDCS|Healthy Controls: These subjects received one single session of active tDCS and one one single session of sham tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received active stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.
340947|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
340948|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
340949|NCT01143636|E4|Reported Event|ACTIVE tDCS - Sham|"ACTIVE tDCS: Subjects will receive a single session of active tDCS. The anode electrode will be placed on the primary motor cortex.~Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes."
340950|NCT01143636|E3|Reported Event|SHAM tDCS - Healthy|"SHAM tDCS: Subjects will receive a single session of sham tDCS. The anode electrode will be placed on the primary motor cortex.~For sham-controlled tDCS subjects, the current will be applied only for 30 seconds.~Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes."
340951|NCT01143636|E2|Reported Event|ACTIVE tDCS - Pelvic Pain Patients|"ACTIVE tDCS: Subjects will receive a total of 10 consecutive sessions of active tDCS. During each session, the anode electrode will be placed on the primary motor cortex of the predominant painful side.~Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes."
340952|NCT01143636|E1|Reported Event|SHAM tDCS - Pelvic Pain Patients|"SHAM tDCS: Subjects will receive a total of 10 consecutive sessions of sham tDCS. During each session, the anode electrode will be placed on the primary motor cortex of the predominant painful side.~For sham-controlled tDCS subjects, the current will be applied only for 30 seconds.~Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes."
340953|NCT01143610|B3|Baseline|Total|Total of all reporting groups
340954|NCT01143610|B2|Baseline|Subepithelial Connective Tissue Graft|Miller class I or II deep recessions treated by subepithelial connective tissue graft.
340955|NCT01143610|B1|Baseline|Newly Forming Bone|Miller class I or II deep recessions treated by the newly forming bone technique.
340956|NCT01143610|P2|Participant Flow|Subepithelial Connective Tissue Graft|Miller class I or II deep recessions treated by subepithelial connective tissue graft.
340957|NCT01143610|P1|Participant Flow|Newly Forming Bone|Miller class I or II deep recessions treated by the newly forming bone technique.
340958|NCT01143610|O2|Outcome|Subepithelial Connective Tissue Graft|Miller class I or II deep recessions treated by subepithelial connective tissue graft.
340959|NCT01143610|O1|Outcome|Newly Forming Bone|Miller class I or II deep recessions treated by the newly forming bone technique.
340960|NCT01143610|O2|Outcome|Subepithelial Connective Tissue Graft|Miller class I or II deep recessions treated by subepithelial connective tissue graft.
340961|NCT01143610|O1|Outcome|Newly Forming Bone|Miller class I or II deep recessions treated by the newly forming bone technique.
340962|NCT01143610|E2|Reported Event|Subepithelial Connective Tissue Graft|Miller class I or II deep recessions treated by subepithelial connective tissue graft.
340963|NCT01143610|E1|Reported Event|Newly Forming Bone|Miller class I or II deep recessions treated by the newly forming bone technique.
340964|NCT01143402|B4|Baseline|Total|Total of all reporting groups
340965|NCT01143402|B3|Baseline|Non-Randomized (Selumetinib)|Non-Randomized to Selumetinib
340966|NCT01143402|B2|Baseline|Arm II (Selumetinib)|Randomized to Selumetinib
340967|NCT01143402|B1|Baseline|Arm I (Temozolomide)|Randomized to Temozolomide
340968|NCT01143402|P3|Participant Flow|Non-Randomized (Selumetinib)|Non-Randomized to Selumetinib
340969|NCT01143402|P2|Participant Flow|Arm II (Selumetinib)|Randomized to Selumetinib
340970|NCT01143402|P1|Participant Flow|Arm I (Temozolomide)|Randomized to Temozolomide
340971|NCT01143402|O2|Outcome|Arm II (Selumetinib)|Randomized to Selumetinib
340972|NCT01143402|O1|Outcome|Arm I (Temozolomide)|Randomized to Temozolomide
340973|NCT01143402|O2|Outcome|Arm II (Selumetinib)|Randomized to Selumetinib
340974|NCT01143402|O1|Outcome|Arm I (Temozolomide)|Randomized to Temozolomide
340975|NCT01143402|E3|Reported Event|Non-Randomized (Selumetinib)|Non-Randomized to Selumetinib
340976|NCT01143402|E2|Reported Event|Arm II (Selumetinib)|Randomized to Selumetinib
340977|NCT01143402|E1|Reported Event|Arm I (Temozolomide)|Randomized to Temozolomide
340978|NCT01143389|B3|Baseline|Total|Total of all reporting groups
340979|NCT01143389|B2|Baseline|Riboflavin 0.1% Eyedrops Every 2 Minutes|"The eye will be irradiated for 30 minutes with UVX light, during which time instillation of riboflavin will continue (1 drop every 2 minutes for this arm).~Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.~UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin."
340980|NCT01143389|B1|Baseline|Riboflavin 0.1% Eyedrops Every 5 Minutes|"The eye will be irradiated for 30 minutes with UVX light, during which time instillation of riboflavin will continue (1 drop every 5 minutes for this arm).~Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.~UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin."
340981|NCT01143389|P2|Participant Flow|Riboflavin 0.1% Eyedrops Every 2 Minutes|"The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 2 minutes for this arm).~Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.~UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin."
340982|NCT01143389|P1|Participant Flow|Riboflavin 0.1% Eyedrops Every 5 Minutes|"The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 5 minutes for this arm).~Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.~UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin."
340983|NCT01143389|O2|Outcome|Riboflavin 0.1% Eyedrops Every 2 Minutes|"The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 2 minutes for this arm).~Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.~UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin."
341150|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
352879|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
340984|NCT01143389|O1|Outcome|Riboflavin 0.1% Eyedrops Every 5 Minutes|"The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 5 minutes for this arm).~Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.~UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin."
340985|NCT01143389|O2|Outcome|Riboflavin 0.1% Eyedrops Every 2 Minutes|"The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 2 minutes for this arm).~Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.~UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin."
340986|NCT01143389|O1|Outcome|Riboflavin 0.1% Eyedrops Every 5 Minutes|"The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 5 minutes for this arm).~Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.~UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin."
340987|NCT01143389|O2|Outcome|Riboflavin 0.1% Eyedrops Every 2 Minutes|"The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 2 minutes for this arm).~Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.~UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin."
340988|NCT01143389|O1|Outcome|Riboflavin 0.1% Eyedrops Every 5 Minutes|"The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 5 minutes for this arm).~Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.~UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin."
340989|NCT01143389|O2|Outcome|Riboflavin 0.1% Eyedrops Every 2 Minutes|"The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 2 minutes for this arm).~Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.~UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin."
340990|NCT01143389|O1|Outcome|Riboflavin 0.1% Eyedrops Every 5 Minutes|"The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 5 minutes for this arm).~Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.~UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin."
340991|NCT01143389|E2|Reported Event|Riboflavin 0.1% Eyedrops Every 2 Minutes|"The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 2 minutes for this arm).~Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.~UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin."
340992|NCT01143389|E1|Reported Event|Riboflavin 0.1% Eyedrops Every 5 Minutes|"The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 5 minutes for this arm).~Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.~UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin."
340993|NCT01143337|B3|Baseline|Total|Total of all reporting groups
340994|NCT01143337|B2|Baseline|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.~MP-435 400mg:~There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.~Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
340995|NCT01143337|B1|Baseline|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
340996|NCT01143337|P3|Participant Flow|MP-435 400mg BID|MP-435 400mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.
340997|NCT01143337|P2|Participant Flow|MP-435 100mg BID|MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.
340998|NCT01143337|P1|Participant Flow|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
340999|NCT01143337|O2|Outcome|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.~MP-435 400mg:~There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.~Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
341000|NCT01143337|O1|Outcome|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
341001|NCT01143337|O2|Outcome|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.~MP-435 400mg:~There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.~Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
341002|NCT01143337|O1|Outcome|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
341029|NCT01143272|B1|Baseline|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
341386|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
341003|NCT01143337|O2|Outcome|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.~MP-435 400mg:~There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.~Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
341004|NCT01143337|O1|Outcome|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
341005|NCT01143337|O2|Outcome|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.~MP-435 400mg:~There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.~Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
341006|NCT01143337|O1|Outcome|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
341007|NCT01143337|O2|Outcome|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.~MP-435 400mg:~There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.~Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
341008|NCT01143337|O1|Outcome|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
341009|NCT01143337|E2|Reported Event|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.~MP-435 400mg:~There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.~Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
341010|NCT01143337|E1|Reported Event|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
341011|NCT01143324|B1|Baseline|MAST™ Procedure|Single Arm Study with MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
341012|NCT01143324|P1|Participant Flow|MAST™ Procedure|Single Arm Study with MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
341013|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
341014|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
341015|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
341016|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
341017|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
341018|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
341019|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
341020|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
341021|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
341022|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
341023|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
341024|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
341025|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
341026|NCT01143324|E1|Reported Event|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
341027|NCT01143272|B3|Baseline|Total|Total of all reporting groups
341028|NCT01143272|B2|Baseline|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
341031|NCT01143272|P1|Participant Flow|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
341032|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
341033|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
341034|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
341035|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
341036|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
341037|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
341038|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
341039|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
341040|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
341041|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
341042|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
341043|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
341044|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
341045|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
341046|NCT01143272|E2|Reported Event|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
341047|NCT01143272|E1|Reported Event|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
341048|NCT01143259|B3|Baseline|Total|Total of all reporting groups
341049|NCT01143259|B2|Baseline|Alvimopan|Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.
341050|NCT01143259|B1|Baseline|300 mg Polyethylene|Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
341051|NCT01143259|P2|Participant Flow|Alvimopan|Treatment Group : The treatment group will receive 12mg of Alvimopan by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.
341052|NCT01143259|P1|Participant Flow|300 mg Polyethylene|Control Group : The control group will receive 300mg of polyethylene glyco by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
341053|NCT01143259|O2|Outcome|Alvimopan|Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.
341054|NCT01143259|O1|Outcome|300 mg Polyethylene|Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
341055|NCT01143259|O2|Outcome|Alvimopan|Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.
341057|NCT01143259|E2|Reported Event|Alvimopan|Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
341058|NCT01143259|E1|Reported Event|300 mg Polyethylene|Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
341059|NCT01143207|B1|Baseline|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
341060|NCT01143207|P1|Participant Flow|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
341061|NCT01143207|O1|Outcome|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
341062|NCT01143207|O1|Outcome|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
341063|NCT01143207|O1|Outcome|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
341064|NCT01143207|O1|Outcome|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
341065|NCT01143207|O1|Outcome|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
341066|NCT01143207|O1|Outcome|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
341067|NCT01143207|E1|Reported Event|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
341068|NCT01143142|B3|Baseline|Total|Total of all reporting groups
341069|NCT01143142|B2|Baseline|Untailored Information|"Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
341070|NCT01143142|B1|Baseline|Tailoring|"Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
341071|NCT01143142|P2|Participant Flow|Untailored Information|"Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
341072|NCT01143142|P1|Participant Flow|Tailoring|"Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
341073|NCT01143142|O2|Outcome|Untailored Information|"Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
341074|NCT01143142|O1|Outcome|Tailoring|"Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
341075|NCT01143142|O2|Outcome|Untailored Information|"Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
341076|NCT01143142|O1|Outcome|Tailoring|"Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
341077|NCT01143142|E2|Reported Event|Untailored Information|"Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
341151|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
341387|NCT01142193|O2|Outcome|Placebo|Placebo
341078|NCT01143142|E1|Reported Event|Tailoring|"Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
341079|NCT01143090|B1|Baseline|Open Label|Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study. One enrolled subject did not receive any study medication and was excluded from this summary.
341080|NCT01143090|P1|Participant Flow|Open Label|Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study.
341081|NCT01143090|O1|Outcome|Lurasidone Overall|
341082|NCT01143090|E1|Reported Event|Open Label|Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study. One enrolled subject did not receive any study medication and was excluded from this summary.
341083|NCT01143077|B4|Baseline|Total|Total of all reporting groups
341084|NCT01143077|B3|Baseline|Lurasidone Open-Label Arm 80/80|Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks
341085|NCT01143077|B2|Baseline|Lurasidone Open-Label Arm 40/80|Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily
341086|NCT01143077|B1|Baseline|Lurasidone Open-Label Arm 40/40|Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg
341087|NCT01143077|P3|Participant Flow|Lurasidone Open-Label Arm 80/80|Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks
341088|NCT01143077|P2|Participant Flow|Lurasidone Open-Label Arm 40/80|Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily
341089|NCT01143077|P1|Participant Flow|Lurasidone Open-Label Arm 40/40|Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg
341090|NCT01143077|O3|Outcome|Lurasidone Open-Label Arm 80/80|Lurasidone 80 mg daily for 14 days followed by flexible dosing between 40 and 120 mg dailly for 4 weeks.
341091|NCT01143077|O2|Outcome|Lurasidone Open-Label Arm 40/80|Lurasidone 40 mg daily for 7 days followed by Lurasidone 80 mg daily for 7 days followed by flexible dosing between 40 and 120 mg daily for 4 weeks.
341092|NCT01143077|O1|Outcome|Lurasidone Open-Label Arm 40/40|Lurasidone 40 mg daily for 14 days followed by flexible dosing between 40 and 120 mg daily for 4 weeks.
341093|NCT01143077|O3|Outcome|Lurasidone Open-Label Arm 80/80|Lurasidone 80 mg daily for 14 days followed by flexible dosing between 40 and 120 mg dailly for 4 weeks.
341094|NCT01143077|O2|Outcome|Lurasidone Open-Label Arm 40/80|Lurasidone 40 mg daily for 7 days followed by Lurasidone 80 mg daily for 7 days followed by flexible dosing between 40 and 120 mg daily for 4 weeks.
341095|NCT01143077|O1|Outcome|Lurasidone Open-Label Arm 40/40|Lurasidone 40 mg daily for 14 days followed by flexible dosing between 40 and 120 mg daily for 4 weeks.
341096|NCT01143077|E3|Reported Event|Lurasidone Open-Label Arm 80/80|Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks
341097|NCT01143077|E2|Reported Event|Lurasidone Open-Label Arm 40/80|Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily
341098|NCT01143077|E1|Reported Event|Lurasidone Open-Label Arm 40/40|Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg
341099|NCT01143051|B7|Baseline|Total|Total of all reporting groups
341100|NCT01143051|B6|Baseline|T2, T1, C|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3 Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
341101|NCT01143051|B5|Baseline|T2, C, T1|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
341102|NCT01143051|B4|Baseline|T1, T2, C|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
341103|NCT01143051|B3|Baseline|T1, C, T2|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min.
341104|NCT01143051|B2|Baseline|C, T2, T1|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
341152|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
341388|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
341105|NCT01143051|B1|Baseline|C, T1, T2|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min.
341106|NCT01143051|P6|Participant Flow|T2, T1, C|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3 Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
341107|NCT01143051|P5|Participant Flow|T2, C, T1|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
341108|NCT01143051|P4|Participant Flow|T1, T2, C|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
341109|NCT01143051|P3|Participant Flow|T1, C, T2|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min.
341110|NCT01143051|P2|Participant Flow|C, T2, T1|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
341111|NCT01143051|P1|Participant Flow|C, T1, T2|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min.
341112|NCT01143051|O3|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine
341113|NCT01143051|O2|Outcome|Treatment T2|Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine
341114|NCT01143051|O1|Outcome|Treatment T1|Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine
341115|NCT01143051|O3|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine
341116|NCT01143051|O2|Outcome|Treatment T2|Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine
341117|NCT01143051|O1|Outcome|Treatment T1|Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine
341118|NCT01143051|O3|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine
341119|NCT01143051|O2|Outcome|Treatment T2|Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine
341120|NCT01143051|O1|Outcome|Treatment T1|Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine
341121|NCT01143051|O3|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine
341122|NCT01143051|O2|Outcome|Treatment T2|Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine
341123|NCT01143051|O1|Outcome|Treatment T1|Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine
341124|NCT01143051|O3|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine
341125|NCT01143051|O2|Outcome|Treatment T2|Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine
341126|NCT01143051|O1|Outcome|Treatment T1|Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine
341127|NCT01143051|O3|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine
341128|NCT01143051|O2|Outcome|Treatment T2|Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine
341129|NCT01143051|O1|Outcome|Treatment T1|Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine
341130|NCT01143051|E3|Reported Event|Treatment C|"Active comparator arm utilizing marketed Primatene Mist with CFC propellant at the labeled dose.~epinephrine inhalation aerosol : Single dose 220 mcg/inhalation, 10 inhalations"
341131|NCT01143051|E2|Reported Event|Treatment T2|"HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation~epinephrine inhalation aerosol : HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation, 10 inhalations"
341132|NCT01143051|E1|Reported Event|Treatment T1|"T1 is HFA propelled epinephrine inhalation aerosol 125 mcg/inhalation~epinephrine inhalation aerosol : HFA propelled epinephrine inhalation aerosol, 125 mcg/inhalation, 10 inhalations"
341153|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
341133|NCT01143038|B1|Baseline|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
341134|NCT01143038|P1|Participant Flow|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
341135|NCT01143038|O1|Outcome|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
341136|NCT01143038|O1|Outcome|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
341137|NCT01143038|O1|Outcome|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
341138|NCT01143038|O1|Outcome|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
341139|NCT01143038|O1|Outcome|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
341140|NCT01143038|E1|Reported Event|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
341141|NCT01142908|B3|Baseline|Total|Total of all reporting groups
341142|NCT01142908|B2|Baseline|Education Control|The education control group - these participants will receive educational material about CVD reduction.
341143|NCT01142908|B1|Baseline|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
341144|NCT01142908|P2|Participant Flow|Education Control|The education control group - these participants will receive educational material about CVD reduction.
341145|NCT01142908|P1|Participant Flow|Pharmacist CVD|The pharmacist cardiovascular (CVD) intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
341146|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
341147|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
341148|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
341149|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
341389|NCT01142193|O2|Outcome|Placebo|Placebo
341155|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
341156|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
341157|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
341158|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
341159|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
341160|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
341161|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
341162|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
341163|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
341164|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
341165|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
341166|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
341167|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
341168|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
341169|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
341170|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
341171|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
341172|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
341173|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
341174|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
341175|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
341176|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
341177|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
341178|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
341179|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
341180|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
341181|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
341182|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
341183|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
341184|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
341185|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
341186|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
341187|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
341188|NCT01142908|E2|Reported Event|Education Control|The education control group - these participants will receive educational material about CVD reduction.
341189|NCT01142908|E1|Reported Event|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
341190|NCT01142726|B4|Baseline|Total|Total of all reporting groups
341191|NCT01142726|B3|Baseline|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
341192|NCT01142726|B2|Baseline|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
341330|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
341193|NCT01142726|B1|Baseline|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
341194|NCT01142726|P3|Participant Flow|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
341195|NCT01142726|P2|Participant Flow|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
341196|NCT01142726|P1|Participant Flow|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept subcutaneous (SC) 125 mg/week and MTX.
341197|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
341198|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
341199|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
341200|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
341201|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
341220|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
352880|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
341202|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
341203|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
341204|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
341205|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
341206|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
341207|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
341208|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
341209|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
341221|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
341222|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
341210|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
341211|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
341212|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
341213|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
341214|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
341215|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
341216|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
341217|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
341218|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
341219|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
341331|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
341223|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
341224|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
341225|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
341226|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
341227|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|"Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period~Methotrexate: Tablets, oral, 2.5 mg, once weekly, 12 months~Abatacept placebo: Injection, subcutaneous, to match 125 mg by syringe, once weekly, 12 months"
341228|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|"Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period~Abatacept: Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months~Methotrexate placebo: Tablets, oral, to match 2.5-mg tablet, once weekly, 12 months"
341229|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|"Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period~Abatacept: Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months~Methotrexate: Tablets, oral, 2.5 mg, once weekly, 12 months"
341230|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|"Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period~Methotrexate: Tablets, oral, 2.5 mg, once weekly, 12 months~Abatacept placebo: Injection, subcutaneous, to match 125 mg by syringe, once weekly, 12 months"
341231|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|"Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period~Abatacept: Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months~Methotrexate placebo: Tablets, oral, to match 2.5-mg tablet, once weekly, 12 months"
341232|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|"Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period~Abatacept: Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months~Methotrexate: Tablets, oral, 2.5 mg, once weekly, 12 months"
341233|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
341234|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
341235|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
341236|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
341237|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
341238|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
341239|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
341240|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
341241|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
341242|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
341243|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
341244|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
341245|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
341246|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
341247|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
341248|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
341249|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
341250|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
341251|NCT01142726|O2|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
341252|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
341253|NCT01142726|O2|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
341254|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
341255|NCT01142726|E3|Reported Event|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a LDAS defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of RA symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX. Safety data was collected from Day 1 to 56 days post last dose.
341256|NCT01142726|E2|Reported Event|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a LDAS defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of RA symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX. Safety data was collected from Day 1 to 56 days post last dose.
341257|NCT01142726|E1|Reported Event|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a LDAS defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of RA symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC 125 mg/week and MTX. Safety data was collected from Day 1 to 56 days post last dose.
341258|NCT01142661|B1|Baseline|Eribulin Mesylate|Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
341259|NCT01142661|P1|Participant Flow|Eribulin Mesylate|Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
341260|NCT01142661|O1|Outcome|Eribulin Mesylate|Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
341261|NCT01142661|O1|Outcome|Eribulin Mesylate|Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
341262|NCT01142661|E1|Reported Event|Eribulin Mesylate|Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
341263|NCT01142596|B3|Baseline|Total|Total of all reporting groups
341264|NCT01142596|B2|Baseline|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341265|NCT01142596|B1|Baseline|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341266|NCT01142596|P2|Participant Flow|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341267|NCT01142596|P1|Participant Flow|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124 (NCT01098110), and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341268|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341322|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
341323|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
341269|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341270|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341271|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341272|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341273|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341274|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341275|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341276|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341277|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341278|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341279|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341280|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341281|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341282|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341283|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341284|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341324|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
341325|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
341326|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
341285|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341286|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341287|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341288|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341289|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341290|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341291|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341292|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341293|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341294|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341295|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341296|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341297|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341298|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341299|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341300|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341327|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
341328|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
341329|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
341301|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341302|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341303|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341304|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341305|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341306|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341307|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341308|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341309|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341310|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341311|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341312|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341313|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341314|NCT01142596|E2|Reported Event|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341315|NCT01142596|E1|Reported Event|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
341316|NCT01142466|B3|Baseline|Total|Total of all reporting groups
341317|NCT01142466|B2|Baseline|No Treatment|Participants in this group did not receive any treatment.
341318|NCT01142466|B1|Baseline|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
341319|NCT01142466|P2|Participant Flow|No Treatment|Participants in this group did not receive any treatment.
341320|NCT01142466|P1|Participant Flow|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
341321|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
341332|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
341333|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
341334|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
341335|NCT01142466|E2|Reported Event|No Treatment|Participants in this group did not receive any treatment.
341336|NCT01142466|E1|Reported Event|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
341337|NCT01142388|B3|Baseline|Total|Total of all reporting groups
341338|NCT01142388|B2|Baseline|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.~cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight~paclitaxel: Given IV"
341339|NCT01142388|B1|Baseline|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.~paclitaxel: Given IV"
341340|NCT01142388|P2|Participant Flow|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.~cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight~paclitaxel: Given IV"
341341|NCT01142388|P1|Participant Flow|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.~paclitaxel: Given IV"
341342|NCT01142388|O2|Outcome|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.~cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight~paclitaxel: Given IV"
341343|NCT01142388|O1|Outcome|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.~paclitaxel: Given IV"
341344|NCT01142388|O2|Outcome|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.~cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight~paclitaxel: Given IV"
341345|NCT01142388|O1|Outcome|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.~paclitaxel: Given IV"
341346|NCT01142388|O2|Outcome|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.~cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight~paclitaxel: Given IV"
341347|NCT01142388|O1|Outcome|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.~paclitaxel: Given IV"
341348|NCT01142388|E2|Reported Event|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.~cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight~paclitaxel: Given IV"
341349|NCT01142388|E1|Reported Event|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.~paclitaxel: Given IV"
341350|NCT01142336|B3|Baseline|Total|Total of all reporting groups
341351|NCT01142336|B2|Baseline|Simvastatin|Simvastatin 40mg qHS for 1 year
341352|NCT01142336|B1|Baseline|Placebo|Placebo 1 tablet qHS for 1 year
341353|NCT01142336|P2|Participant Flow|Placebo|Placebo 1 tablet qHS for 1 year
341354|NCT01142336|P1|Participant Flow|Simvastatin|Simvastatin 40mg qHS for 1 year
341355|NCT01142336|O2|Outcome|Simvastatin|Simvastatin 40mg qHS for 1 year
341356|NCT01142336|O1|Outcome|Placebo|Placebo 1 tablet qHS for 1 year
341357|NCT01142336|O2|Outcome|Simvastatin|40mg qHS for 1 year
341358|NCT01142336|O1|Outcome|Placebo|1 tablet qHS for 1 year
341359|NCT01142336|O2|Outcome|Simvastatin|40mg qHS for 1 year
341360|NCT01142336|O1|Outcome|Placebo|1 tab qHS for 1 year
341361|NCT01142336|E2|Reported Event|Placebo|Placebo 1 tablet qHS for 1 year
341362|NCT01142336|E1|Reported Event|Simvastatin|Simvastatin 40mg qHS for 1 year
341363|NCT01142323|B1|Baseline|Fenofibrate|fenofibrate 160 mg po daily
341364|NCT01142323|P1|Participant Flow|Fenofibrate|fenofibrate 160 mg po daily
341365|NCT01142323|O1|Outcome|Fenofibrate|"fenofibrate 160 mg po daily~fenofibrate: 160 mg po daily"
341366|NCT01142323|O2|Outcome|At 6 Months|fenofibrate 160 mg/day
341367|NCT01142323|O1|Outcome|Baseline|Prior to drug intervention
341368|NCT01142323|E1|Reported Event|Fenofibrate|fenofibrate 160 mg po daily
341369|NCT01142297|B1|Baseline|Dental Implant|"standard SLA surface and chemically modified surface~dental implant : standard SLA surface and modified dental implant : chemically modified surface"
341370|NCT01142297|P1|Participant Flow|Dental Implant|standard SLA surface and chemically-modified surface implant
341371|NCT01142297|O1|Outcome|Clinical Success of Implants|Successful outcome of implant after one year
341372|NCT01142297|O2|Outcome|Modified SLA Minimum ISQ HbA1c<9.5|"chemically modified surface~modified dental implant : chemically modified surface"
341373|NCT01142297|O1|Outcome|SLA Minimum ISQ HbA1c<9.5|"standard SLA surface~dental implant : standard SLA surface"
341374|NCT01142297|E2|Reported Event|Modified Dental Implant|"chemically modified surface~modified dental implant : chemically modified surface"
341375|NCT01142297|E1|Reported Event|Dental Implant|"standard SLA surface~dental implant : standard SLA surface"
341376|NCT01142193|B3|Baseline|Total|Total of all reporting groups
341377|NCT01142193|B2|Baseline|Placebo|Placebo
341378|NCT01142193|B1|Baseline|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
341379|NCT01142193|P2|Participant Flow|Placebo|Placebo
341380|NCT01142193|P1|Participant Flow|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
341381|NCT01142193|O2|Outcome|Placebo|Placebo
341382|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
341383|NCT01142193|O2|Outcome|Placebo|Placebo
341390|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
341391|NCT01142193|O2|Outcome|Placebo|Placebo
341392|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
341393|NCT01142193|O2|Outcome|Placebo|Placebo
341394|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
341395|NCT01142193|O2|Outcome|Placebo|Placebo
341396|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
341397|NCT01142193|O2|Outcome|Placebo|Placebo
341398|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
341399|NCT01142193|O2|Outcome|Placebo|Placebo
341400|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
341401|NCT01142193|E2|Reported Event|Placebo|Placebo
341402|NCT01142193|E1|Reported Event|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
341403|NCT01142128|B5|Baseline|Total|Total of all reporting groups
341404|NCT01142128|B4|Baseline|Viokase 16 Plus Placebo to Nexium|Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone
341405|NCT01142128|B3|Baseline|Viokase 16 Plus Nexium|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
341406|NCT01142128|B2|Baseline|Placebo to Nexium, Alone|Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium
341407|NCT01142128|B1|Baseline|Nexium Alone|Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium
341408|NCT01142128|P1|Participant Flow|All Participants|"Participants received one of four interventions in a randomized crossover design:~Nexium Alone: Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium~Placebo to Nexium, Alone: Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium~Viokase 16 Plus Nexium: Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium~Viokase 16 Plus Placebo to Nexium: Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone"
341409|NCT01142128|O1|Outcome|Viokase 16 Plus Placebo to Nexium|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
341410|NCT01142128|O1|Outcome|Viokase 16 Plus Nexium|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
341411|NCT01142128|O1|Outcome|Placebo to Nexium, Alone|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
341412|NCT01142128|O1|Outcome|Nexium Alone|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
341413|NCT01142128|E4|Reported Event|Viokase 16 Plus Placebo to Nexium|Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone
341414|NCT01142128|E3|Reported Event|Viokase 16 Plus Nexium|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
341415|NCT01142128|E2|Reported Event|Placebo to Nexium, Alone|Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium
341416|NCT01142128|E1|Reported Event|Nexium Alone|Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium
341417|NCT01142115|B1|Baseline|Entire Study Population|Includes groups randomized to receive SpeediCath first and Monza first
341418|NCT01142115|P2|Participant Flow|Monza First, Then SpeediCath|Catheterization with Monza catheter on visit 1. Catheterization with SpeediCath catheter on visit 2.
341419|NCT01142115|P1|Participant Flow|SpeediCath First, Then Monza|Catheterization with SpeediCath catheter on visit 1. Catheterization with Monza catheter on visit 2.
341420|NCT01142115|O2|Outcome|SpeediCath|Control Product
341421|NCT01142115|O1|Outcome|Monza|Test product
341422|NCT01142115|O2|Outcome|SpeediCath|Control Product
341423|NCT01142115|O1|Outcome|Monza|Test product
341424|NCT01142115|O2|Outcome|SpeediCath|Control Product
341425|NCT01142115|O1|Outcome|Monza|Test product
341426|NCT01142115|O2|Outcome|SpeediCath|Control Product
341427|NCT01142115|O1|Outcome|Monza|Test product
341428|NCT01142115|O2|Outcome|SpeediCath|Control Product
341429|NCT01142115|O1|Outcome|Monza|Test product
341430|NCT01142115|O2|Outcome|SpeediCath|Control Product
341431|NCT01142115|O1|Outcome|Monza|Test product
341432|NCT01142115|E1|Reported Event|Entire Study Population|Includes groups randomized to receive SpeediCath first and Monza first
341433|NCT01142089|B3|Baseline|Total|Total of all reporting groups
341434|NCT01142089|B2|Baseline|Rifamycin SV MMX|"Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).~Rifamycin SV MMX: Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).~Intent To Treat (ITT)"
341435|NCT01142089|B1|Baseline|Placebo|"Placebo (two matching tablets) orally twice daily for 3 days (72 hours)~Placebo: Placebo (two matching tablets) orally twice daily for 3 days (72 hours).~Intent To Treat (ITT)"
341436|NCT01142089|P2|Participant Flow|Rifamycin SV MMX|"Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).~Rifamycin SV MMX: Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).~Intent To Treat (ITT)"
341437|NCT01142089|P1|Participant Flow|Placebo|"Placebo (two matching tablets) orally twice daily for 3 days (72 hours)~Placebo: Placebo (two matching tablets) orally twice daily for 3 days (72 hours).~Intent To Treat (ITT)"
352881|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
341438|NCT01142089|O2|Outcome|Rifamycin SV MMX|"Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).~Rifamycin SV MMX: Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).~Intent To Treat (ITT)"
341439|NCT01142089|O1|Outcome|Placebo|"Placebo (two matching tablets) orally twice daily for 3 days (72 hours)~Placebo: Placebo (two matching tablets) orally twice daily for 3 days (72 hours).~Intent To Treat (ITT)"
341440|NCT01142089|O2|Outcome|Rifamycin SV MMX|"Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).~Rifamycin SV MMX: Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).~Intent To Treat (ITT)"
341441|NCT01142089|O1|Outcome|Placebo|"Placebo (two matching tablets) orally twice daily for 3 days (72 hours)~Placebo: Placebo (two matching tablets) orally twice daily for 3 days (72 hours).~Intent To Treat (ITT)"
341442|NCT01142089|E2|Reported Event|Rifamycin SV MMX|"Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).~Rifamycin SV MMX: Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).~Intent To Treat (ITT)"
341443|NCT01142089|E1|Reported Event|Placebo|"Placebo (two matching tablets) orally twice daily for 3 days (72 hours)~Placebo: Placebo (two matching tablets) orally twice daily for 3 days (72 hours).~Intent To Treat (ITT)"
341444|NCT01141725|B1|Baseline|Treatment (Combination Chemotherapy)|"Patients receive bendamustine hydrochloride IV on days 1-5 and idarubicin IV on days 1 and 2. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~bendamustine hydrochloride: Given IV~idarubicin: Given IV"
341445|NCT01141725|P3|Participant Flow|Bendamustine Dose of 75mg/m2/Day|"Patients receive bendamustine hydrochloride 75mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.~Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity."
341446|NCT01141725|P2|Participant Flow|Bendamustine Dose of 60mg/m2/Day|"Patients receive bendamustine hydrochloride 60mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.~Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity."
341447|NCT01141725|P1|Participant Flow|Bendamustine Dose of 45mg/m2/Day|"Patients receive bendamustine hydrochloride 45mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.~Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity."
341448|NCT01141725|O1|Outcome|Treatment (Combination Chemotherapy)|"Patients receive bendamustine hydrochloride IV on days 1-5 and idarubicin IV on days 1 and 2. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~bendamustine hydrochloride: Given IV~idarubicin: Given IV"
341449|NCT01141725|O1|Outcome|Treatment (Combination Chemotherapy)|"Patients receive bendamustine hydrochloride IV on days 1-5 and idarubicin IV on days 1 and 2. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~bendamustine hydrochloride: Given IV~idarubicin: Given IV"
341450|NCT01141725|O1|Outcome|Treatment (Combination Chemotherapy)|"Patients receive bendamustine hydrochloride IV on days 1-5 and idarubicin IV on days 1 and 2. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~bendamustine hydrochloride: Given IV~idarubicin: Given IV"
341451|NCT01141725|O3|Outcome|Treatment C|"Patients receive bendamustine hydrochloride 75mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.~Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity."
341452|NCT01141725|O2|Outcome|Treatment B|"Patients receive bendamustine hydrochloride 60mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.~Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity."
341453|NCT01141725|O1|Outcome|Treatment A|"Patients receive bendamustine hydrochloride 45mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.~Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity."
341454|NCT01141725|O3|Outcome|Treatment C|"Patients receive bendamustine hydrochloride 75mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.~Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity."
341455|NCT01141725|O2|Outcome|Treatment B|"Patients receive bendamustine hydrochloride 60mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.~Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity."
341456|NCT01141725|O1|Outcome|Treatment A|"Patients receive bendamustine hydrochloride 45mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.~Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity."
341457|NCT01141725|E1|Reported Event|Treatment (Combination Chemotherapy)|"Patients receive bendamustine hydrochloride IV on days 1-5 and idarubicin IV on days 1 and 2. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~bendamustine hydrochloride: Given IV~idarubicin: Given IV~Adverse event report was not collected by dose level."
341458|NCT01141712|B1|Baseline|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 twice a day (BID) on Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
341459|NCT01141712|P1|Participant Flow|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 twice a day from Days -5 to -2, Cytarabine 100 mg/m^2 twice a day from Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
341460|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
341461|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
341462|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
341463|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
352882|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
341464|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
341465|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
341466|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
341467|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
341468|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
341469|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
341470|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
341471|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
341472|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
341473|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
341474|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
341475|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
341476|NCT01141712|E1|Reported Event|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
341477|NCT01141660|B3|Baseline|Total|Total of all reporting groups
341478|NCT01141660|B2|Baseline|Laryngeal Mask Airway|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
341479|NCT01141660|B1|Baseline|Endotracheal Tube|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
341480|NCT01141660|P2|Participant Flow|Laryngeal Mask Airway|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
341481|NCT01141660|P1|Participant Flow|Endotracheal Tube|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
341482|NCT01141660|O2|Outcome|Laryngeal Mask Airway|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
341483|NCT01141660|O1|Outcome|Endotracheal Tube|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
341484|NCT01141660|O2|Outcome|Laryngeal Mask Airway|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
341485|NCT01141660|O1|Outcome|Endotracheal Tube|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
341486|NCT01141660|E2|Reported Event|Laryngeal Mask Airway|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
341487|NCT01141660|E1|Reported Event|Endotracheal Tube|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
341488|NCT01141647|B1|Baseline|24-Month Supported Employment|"Evidence-Based Supported Employment Vocational Rehabilitation or Other Vocational Services~Vocational Rehabilitation: SCI-VIP: PrOMOTE evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services"
341489|NCT01141647|P1|Participant Flow|24-Month Supported Employment|Evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services
341490|NCT01141647|O2|Outcome|Participants in SCI-VIP Standard Care|Standard Care group from SCI-VIP trial (NCT00117806): Standard care varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
341491|NCT01141647|O1|Outcome|24-Month Supported Employment|Participants in Supported Employment.
341492|NCT01141647|O2|Outcome|Participants in SCI-VIP Standard Care|Standard Care group from SCI-VIP trial (NCT00117806): Standard care varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
341493|NCT01141647|O1|Outcome|24-Month Supported Employment|Participants in Supported Employment.
341494|NCT01141647|O3|Outcome|Late Stage|Interview data from clinical staff in year 3.
341495|NCT01141647|O2|Outcome|Mid Stage|Interview data from clinical staff from year 2.
341496|NCT01141647|O1|Outcome|Early Stage|Interview data from clinical staff during year 1.
341497|NCT01141647|O1|Outcome|48-Month Supported Employment|"Evidence-Based Supported Employment Vocational Rehabilitation or Other Vocational Services~Vocational Rehabilitation: SCI-VIP: PrOMOTE evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services"
341498|NCT01141647|O1|Outcome|24-Month Supported Employment|Participants in Supported Employment.
341499|NCT01141647|O1|Outcome|24-Month Supported Employment|Participants in Supported Employment.
341528|NCT01141374|P2|Participant Flow|Auriculotherapy by Needles|Auriculotherapy with semi-permanent needles of 1.8mm, at shenmen, kidney and brainstem points 1 time per week for 8 weeks.
352883|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
341500|NCT01141647|E1|Reported Event|Baseline Sample (N=1047)|"Evidence-Based Supported Employment Vocational Rehabilitation or Other Vocational Services~Vocational Rehabilitation: SCI-VIP: PrOMOTE evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services"
341501|NCT01141595|B1|Baseline|Kuvan®|Patients will be instructed to take 20 mg/kg/day of Kuvan® orally dissolved in 4 - 8oz. of water or apple juice with breakfast.
341502|NCT01141595|P1|Participant Flow|Kuvan®|Patients will be instructed to take 20 mg/kg/day of Kuvan® orally dissolved in 4 - 8oz. of water or apple juice with breakfast.
341503|NCT01141595|O1|Outcome|Kuvan®|Patients will be instructed to take 20 mg/kg/day of Kuvan® orally dissolved in 4 - 8oz. of water or apple juice with breakfast.
341504|NCT01141595|E1|Reported Event|Kuvan®|Patients will be instructed to take 20 mg/kg/day of Kuvan® orally dissolved in 4 - 8oz. of water or apple juice with breakfast.
341505|NCT01141569|B1|Baseline|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
341506|NCT01141569|P1|Participant Flow|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
341507|NCT01141569|O1|Outcome|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
341508|NCT01141569|O1|Outcome|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
341509|NCT01141569|O1|Outcome|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
341510|NCT01141569|O1|Outcome|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
341511|NCT01141569|O1|Outcome|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
341512|NCT01141569|O1|Outcome|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
341513|NCT01141569|E1|Reported Event|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
341514|NCT01141491|B3|Baseline|Total|Total of all reporting groups
341515|NCT01141491|B2|Baseline|Arm B - OPT-821 Immunologic Adjuvant|OPT-821: Patients will be given 10 injections of adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
341516|NCT01141491|B1|Baseline|Arm A- Vaccine Plus OPT-821|Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
341517|NCT01141491|P2|Participant Flow|Arm B - OPT-821 Immunologic Adjuvant|Patients will be given 10 injections of OPT-821 alone as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
341518|NCT01141491|P1|Participant Flow|Arm A- Vaccine Plus OPT-821|Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
341519|NCT01141491|O2|Outcome|Arm B - OPT-821 Immunologic Adjuvant|"Patients will be given 10 injections of OPT-821 alone as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84~OPT-821: Patients will be given 10 injections of adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84"
341520|NCT01141491|O1|Outcome|Arm A- Vaccine Plus OPT-821|Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
341521|NCT01141491|E2|Reported Event|Arm B - OPT-821 Immunologic Adjuvant|OPT-821: Patients will be given 10 injections of adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
341522|NCT01141491|E1|Reported Event|Arm A- Vaccine Plus OPT-821|Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
341523|NCT01141374|B4|Baseline|Total|Total of all reporting groups
341524|NCT01141374|B3|Baseline|Control Group|untreated group
341525|NCT01141374|B2|Baseline|Auriculotherapy by Needles|Auriculotherapy with semi-permanent needles of 1.8mm, at shenmen, kidney and brainstem points 1 time per week for 8 weeks.
341526|NCT01141374|B1|Baseline|Auriculotherapy by Seeds|Auriculotherapy Group by seeds at Shenmen,kidney and brainstem points,all of them for stress reduction. These points were used 1 time per week for 8 weeks. The subjects were instructed to carry out stimulation 3 times a day for at least 15 times.
341527|NCT01141374|P3|Participant Flow|Control Group|untreated group
341529|NCT01141374|P1|Participant Flow|Auriculotherapy by Seeds|Auriculotherapy Group by seeds at Shenmen,kidney and brainstem points,all of them for stress reduction. These points were used 1 time per week for 8 weeks. The subjects were instructed to carry out stimulation 3 times a day for at least 15 times.
341530|NCT01141374|O3|Outcome|Seeds Group|They received auriculotherapy by seeds at shenmen, kidney and brainstem points, 1 time per week, during 8 weeks (3rd evaluation) and follow-up (4th evaluation).
341531|NCT01141374|O2|Outcome|Needle Group|Subjects received needles at shenmen, kidney and brainstem points, 1 time per week, during 8 weeks (3rd evaluation) and follow-up (4th evaluation).
341532|NCT01141374|O1|Outcome|Control Group|Without intervention
341533|NCT01141374|O3|Outcome|Seeds Group|They received auriculotherapy by seeds at shenmen, kidney and brainstem points, 1 time per week, during 4 weeks (2nd evaluation).
341534|NCT01141374|O2|Outcome|Needle Group|Subjects received needles at shenmen, kidney and brainstem points, 1 time per week, during 4 weeks (2nd evaluation).
341535|NCT01141374|O1|Outcome|Control Group|Without intervention
341536|NCT01141374|E3|Reported Event|Control Group|untreated group
341537|NCT01141374|E2|Reported Event|Auriculotherapy by Needles|Auriculotherapy with semi-permanent needles of 1.8mm, at shenmen, kidney and brainstem points 1 time per week for 8 weeks.
341538|NCT01141374|E1|Reported Event|Auriculotherapy by Seeds|Auriculotherapy Group by seeds at Shenmen,kidney and brainstem points,all of them for stress reduction. These points were used 1 time per week for 8 weeks. The subjects were instructed to carry out stimulation 3 times a day for at least 15 times.
341539|NCT01141283|B1|Baseline|Extension Phase (BTDS 5, 10, or 20)|Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear
341540|NCT01141283|P1|Participant Flow|Extension Phase (BTDS 5, 10, or 20)|Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear
341541|NCT01141283|O1|Outcome|Extension Phase (BTDS 5, 10, or 20)|Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear
341542|NCT01141283|E1|Reported Event|Extension Phase (BTDS 5, 10, or 20)|Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear
341543|NCT01141205|B3|Baseline|Total|Total of all reporting groups
341544|NCT01141205|B2|Baseline|Saline|Saline injection
341545|NCT01141205|B1|Baseline|AFO-18|18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
341546|NCT01141205|P2|Participant Flow|Saline|Placebo was Sterile saline injection, 1.25 ml i.m. (in m. deltoideus) at each vaccination weeks 0, 2, 4, 8
341547|NCT01141205|P1|Participant Flow|AFO-18|18 peptides representing 15 CD8 and 3 CD4 epitopes on HIV-1 plus 1 CD4 T helper epitope unrelated to HIV in an adjuvant (CAF01). Total 4.5 mg peptide (250 micro gram of each peptide) in CAF01 adjuvant. Total volume of 1.25 ml was injected i.m. (in m. deltoideus) at weeks 0, 2, 4, 8
341548|NCT01141205|O2|Outcome|Placebo|participants receiving saline
341549|NCT01141205|O1|Outcome|Vaccinee|participants receiving active peptide in CAF01 adjuvants vaccine
341550|NCT01141205|O2|Outcome|Saline|Placebo participants receiving sterile saline i.m.
341551|NCT01141205|O1|Outcome|Vaccinee|participants receiving active HIV-1 peptide vaccine in CAF01 adjuvant i.m.
341552|NCT01141205|O2|Outcome|Placebo Saline|Saline injection
341553|NCT01141205|O1|Outcome|AFO-18|18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
341554|NCT01141205|O2|Outcome|Placebo|participants receiving saline
341555|NCT01141205|O1|Outcome|Vaccinee|participants receiving active peptide in CAF01 adjuvants vaccine
341556|NCT01141205|E2|Reported Event|Saline|Saline injection
341557|NCT01141205|E1|Reported Event|AFO-18|18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
341558|NCT01140906|B5|Baseline|Total|Total of all reporting groups
341559|NCT01140906|B4|Baseline|Duloxetine 60 mg|encapsulated capsules, daily, orally
341560|NCT01140906|B3|Baseline|Vortioxetine 20 mg|encapsulated tablets, daily, orally
341561|NCT01140906|B2|Baseline|Vortioxetine 15 mg|encapsulated tablets, daily, orally
341562|NCT01140906|B1|Baseline|Placebo|capsules, daily, orally
341563|NCT01140906|P4|Participant Flow|Duloxetine 60 mg|encapsulated capsules, daily, orally
341564|NCT01140906|P3|Participant Flow|Vortioxetine 20 mg|encapsulated tablets, daily, orally
341565|NCT01140906|P2|Participant Flow|Vortioxetine 15 mg|encapsulated tablets, daily, orally
341566|NCT01140906|P1|Participant Flow|Placebo|capsules, daily, orally
341567|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
341568|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
341569|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
341570|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
341571|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
341572|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
341573|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
341574|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
341575|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
341576|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
341577|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
341578|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
341579|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
341580|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
341581|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
341582|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
341583|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
341584|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
341585|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
341586|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
341587|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
341588|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
341589|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
341590|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
341591|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
341592|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
341593|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
341594|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
341595|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
341596|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
341597|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
341598|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
341599|NCT01140906|E4|Reported Event|Duloxetine 60 mg|
341600|NCT01140906|E3|Reported Event|Vortioxetine 20 mg|
341601|NCT01140906|E2|Reported Event|Vortioxetine 15 mg|
341602|NCT01140906|E1|Reported Event|Placebo|
341603|NCT01140880|B3|Baseline|Total|Total of all reporting groups
341604|NCT01140880|B2|Baseline|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
341605|NCT01140880|B1|Baseline|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
341606|NCT01140880|P2|Participant Flow|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
341607|NCT01140880|P1|Participant Flow|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
341608|NCT01140880|O2|Outcome|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
341609|NCT01140880|O1|Outcome|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
341610|NCT01140880|O2|Outcome|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
341611|NCT01140880|O1|Outcome|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
341612|NCT01140880|O2|Outcome|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
341613|NCT01140880|O1|Outcome|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
341614|NCT01140880|O2|Outcome|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
341733|NCT01140061|B8|Baseline|Panel D - Placebo|In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
352884|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
341615|NCT01140880|O1|Outcome|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
341616|NCT01140880|E2|Reported Event|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
341617|NCT01140880|E1|Reported Event|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
341618|NCT01140867|B1|Baseline|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
341619|NCT01140867|P1|Participant Flow|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
341620|NCT01140867|O1|Outcome|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
341621|NCT01140867|O1|Outcome|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
341622|NCT01140867|O1|Outcome|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
341623|NCT01140867|O1|Outcome|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
341624|NCT01140867|E1|Reported Event|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
341625|NCT01140815|B3|Baseline|Total|Total of all reporting groups
341626|NCT01140815|B2|Baseline|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System~Deuce: Smith and Nephew Bicompartmental Knee Replacement"
341627|NCT01140815|B1|Baseline|Total (Control)|"The Smith and Nephew Total Knee System~Total Knee Replacement: Smith and Nephew Total Knee Replacement"
341628|NCT01140815|P2|Participant Flow|Deuce|The Journey Deuce Bicompartmental Knee System
341629|NCT01140815|P1|Participant Flow|Total|The Smith and Nephew Total Knee System
341630|NCT01140815|O2|Outcome|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System~Deuce: Smith and Nephew Bicompartmental Knee Replacement"
341631|NCT01140815|O1|Outcome|Total (Control)|"The Smith and Nephew Total Knee System~Total Knee Replacement: Smith and Nephew Total Knee Replacement"
341632|NCT01140815|O2|Outcome|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System~Deuce: Smith and Nephew Bicompartmental Knee Replacement"
341633|NCT01140815|O1|Outcome|Total (Control)|"The Smith and Nephew Total Knee System~Total Knee Replacement: Smith and Nephew Total Knee Replacement"
341634|NCT01140815|O2|Outcome|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System~Deuce: Smith and Nephew Bicompartmental Knee Replacement"
341635|NCT01140815|O1|Outcome|Total (Control)|"The Smith and Nephew Total Knee System~Total Knee Replacement: Smith and Nephew Total Knee Replacement"
341636|NCT01140815|O2|Outcome|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System~Deuce: Smith and Nephew Bicompartmental Knee Replacement"
341637|NCT01140815|O1|Outcome|Total (Control)|"The Smith and Nephew Total Knee System~Total Knee Replacement: Smith and Nephew Total Knee Replacement"
341638|NCT01140815|O2|Outcome|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System~Deuce: Smith and Nephew Bicompartmental Knee Replacement"
341639|NCT01140815|O1|Outcome|Total (Control)|"The Smith and Nephew Total Knee System~Total Knee Replacement: Smith and Nephew Total Knee Replacement"
341640|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
341641|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
341642|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
341643|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
341644|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
341645|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
341646|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
341647|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
341648|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
341649|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
341650|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
341651|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
341652|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
341653|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
341654|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
341655|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
341656|NCT01140815|E2|Reported Event|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System~Deuce: Smith and Nephew Bicompartmental Knee Replacement"
341657|NCT01140815|E1|Reported Event|Total (Control)|"The Smith and Nephew Total Knee System~Total Knee Replacement: Smith and Nephew Total Knee Replacement"
341658|NCT01140646|B1|Baseline|SAMe|The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
341734|NCT01140061|B7|Baseline|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days
341659|NCT01140646|P1|Participant Flow|SAMe|The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
341660|NCT01140646|O1|Outcome|SAMe|The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
341661|NCT01140646|E1|Reported Event|SAMe|The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
341662|NCT01140503|B1|Baseline|Apremilast|All subjects received apremilast 20mg PO BID
341663|NCT01140503|P1|Participant Flow|Apremilast|All subjects received apremilast 20mg PO BID
341664|NCT01140503|O1|Outcome|Apremilast|All subjects received apremilast 20mg PO BID
341665|NCT01140503|O1|Outcome|Apremilast|All subjects received apremilast 20mg PO BID
341666|NCT01140503|O1|Outcome|Apremilast|All subjects received apremilast 20mg PO BID
341667|NCT01140503|E1|Reported Event|Apremilast|All subjects received apremilast 20mg PO BID
341668|NCT01140477|B3|Baseline|Total|Total of all reporting groups
341669|NCT01140477|B2|Baseline|Crystalens IOL|Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)
341670|NCT01140477|B1|Baseline|Crystalens Toric IOL|Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)
341671|NCT01140477|P2|Participant Flow|Crystalens IOL|Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)
341672|NCT01140477|P1|Participant Flow|Crystalens Toric IOL|Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)
341673|NCT01140477|O2|Outcome|Crystalens IOL|"Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)~Accommodating Lens: Accommodating lens implanted during cataract extraction"
341674|NCT01140477|O1|Outcome|Crystalens Toric IOL|"Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)~Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction"
341675|NCT01140477|O1|Outcome|Crystalens Toric IOL|"Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)~Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction"
341676|NCT01140477|O2|Outcome|Crystalens IOL|"Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)~Accommodating Lens: Accommodating lens implanted during cataract extraction"
341677|NCT01140477|O1|Outcome|Crystalens Toric IOL|"Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)~Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction"
341678|NCT01140477|E2|Reported Event|Crystalens IOL|"Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)~Accommodating Lens: Accommodating lens implanted during cataract extraction"
341679|NCT01140477|E1|Reported Event|Crystalens Toric IOL|"Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)~Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction"
341680|NCT01140360|B1|Baseline|Gleevec|Gleevec will be dosed orally with a starting dose of 100 mg twice daily for patients with a BSA > 1.8 m2 or 55 mg/m2 twice daily for patients with BSA < 1.8 m2. For patients with a BSA > 1.8 m2 the dose will increase by increments of 100 mg bid every two weeks as tolerated up to a maximum dose of 400 mg bid. For patients with a BSA < 1.8 m2 the dose will increase by increments of 55 mg/m2 bid every two weeks as tolerated up to a maximum dose of 220 mg/m2 bid.Treatment will continue for 6 months with an option to continue for 24 months if the patient is deriving a clinical benefit.
341681|NCT01140360|P1|Participant Flow|Gleevec|Gleevec will be dosed orally with a starting dose of 100 mg twice daily for patients with a BSA > 1.8 m2 or 55 mg/m2 twice daily for patients with BSA < 1.8 m2. For patients with a BSA > 1.8 m2 the dose will increase by increments of 100 mg bid every two weeks as tolerated up to a maximum dose of 400 mg bid. For patients with a BSA < 1.8 m2 the dose will increase by increments of 55 mg/m2 bid every two weeks as tolerated up to a maximum dose of 220 mg/m2 bid.Treatment will continue for 6 months with an option to continue for 24 months if the patient is deriving a clinical benefit.
341682|NCT01140360|O1|Outcome|Gleevec|Gleevec will be dosed orally with a starting dose of 100 mg twice daily for patients with a BSA > 1.8 m2 or 55 mg/m2 twice daily for patients with BSA < 1.8 m2. For patients with a BSA > 1.8 m2 the dose will increase by increments of 100 mg bid every two weeks as tolerated up to a maximum dose of 400 mg bid. For patients with a BSA < 1.8 m2 the dose will increase by increments of 55 mg/m2 bid every two weeks as tolerated up to a maximum dose of 220 mg/m2 bid.Treatment will continue for 6 months with an option to continue for 24 months if the patient is deriving a clinical benefit.
341683|NCT01140360|E1|Reported Event|Gleevec|Gleevec will be dosed orally with a starting dose of 100 mg twice daily for patients with a BSA > 1.8 m2 or 55 mg/m2 twice daily for patients with BSA < 1.8 m2. For patients with a BSA > 1.8 m2 the dose will increase by increments of 100 mg bid every two weeks as tolerated up to a maximum dose of 400 mg bid. For patients with a BSA < 1.8 m2 the dose will increase by increments of 55 mg/m2 bid every two weeks as tolerated up to a maximum dose of 220 mg/m2 bid.Treatment will continue for 6 months with an option to continue for 24 months if the patient is deriving a clinical benefit.
341684|NCT01140347|B3|Baseline|Total|Total of all reporting groups
341685|NCT01140347|B2|Baseline|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
341686|NCT01140347|B1|Baseline|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
341687|NCT01140347|P2|Participant Flow|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
341735|NCT01140061|B6|Baseline|Panel C - Placebo|In Part II, healthy participants received skin application of placebo cream once daily for 10 days.
342125|NCT01138969|E2|Reported Event|Clopidogrel Group|clopidogrel 75 mg qd for 6 months
341688|NCT01140347|P1|Participant Flow|Ramucirumab (IMC-1121B) + BSC|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) intravenous (IV) infusion every 2 weeks.~Best supportive care (BSC): Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator."
341689|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
341690|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
341691|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
341692|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
341693|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
341694|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
341695|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
341696|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
341697|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
341698|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
341699|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
341700|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
341701|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
341702|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
341703|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
341704|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
341705|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
341706|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
341707|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
341708|NCT01140347|E2|Reported Event|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
341709|NCT01140347|E1|Reported Event|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
341710|NCT01140295|B3|Baseline|Total|Total of all reporting groups
341711|NCT01140295|B2|Baseline|2, Senna|"Senna colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.~Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
341736|NCT01140061|B5|Baseline|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
341712|NCT01140295|B1|Baseline|1, Miralax|"Miralax colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.~Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
341713|NCT01140295|P2|Participant Flow|2, Senna|"Senna colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure."
341714|NCT01140295|P1|Participant Flow|1, Miralax|"Miralax colonoscopy preparation~Miralax (PEG-P) at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
341715|NCT01140295|O2|Outcome|2, Senna|"Senna colonoscopy preparation~Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure."
341716|NCT01140295|O1|Outcome|1, Miralax|"Miralax colonoscopy preparation~Miralax (PEG-P) at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
341717|NCT01140295|O2|Outcome|2, Senna|"Senna colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.~Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
341718|NCT01140295|O1|Outcome|1, Miralax|"Miralax colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.~Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
341719|NCT01140295|E2|Reported Event|2, Senna|"Senna colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.~Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
341720|NCT01140295|E1|Reported Event|1, Miralax|"Miralax colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.~Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
341721|NCT01140191|B1|Baseline|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396~WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
341722|NCT01140191|P1|Participant Flow|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396~WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
341723|NCT01140191|O1|Outcome|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396~WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
341724|NCT01140191|O1|Outcome|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396~WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
341725|NCT01140191|O1|Outcome|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396~WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
341726|NCT01140191|O1|Outcome|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396~WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
341727|NCT01140191|O1|Outcome|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396~WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
341728|NCT01140191|O1|Outcome|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396~WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
341729|NCT01140191|E1|Reported Event|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396~WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
341730|NCT01140061|B11|Baseline|Total|Total of all reporting groups
341731|NCT01140061|B10|Baseline|Panel E and Extension - Placebo|In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days.
341732|NCT01140061|B9|Baseline|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
341737|NCT01140061|B4|Baseline|Panel B - Placebo|In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
341738|NCT01140061|B3|Baseline|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
341739|NCT01140061|B2|Baseline|Panel A - Placebo|In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days
341740|NCT01140061|B1|Baseline|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
341741|NCT01140061|P10|Participant Flow|Panel E and Extension - Placebo|In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days.
341742|NCT01140061|P9|Participant Flow|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
341743|NCT01140061|P8|Participant Flow|Panel D - Placebo|In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
341744|NCT01140061|P7|Participant Flow|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
341745|NCT01140061|P6|Participant Flow|Panel C - Placebo|In Part II, healthy participants received skin application of placebo cream once daily for 10 days.
341746|NCT01140061|P5|Participant Flow|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
341747|NCT01140061|P4|Participant Flow|Panel B - Placebo|In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
341748|NCT01140061|P3|Participant Flow|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
341749|NCT01140061|P2|Participant Flow|Panel A - Placebo|In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days.
341750|NCT01140061|P1|Participant Flow|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
341751|NCT01140061|O6|Outcome|Placebo - Pooled|In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis.
341752|NCT01140061|O5|Outcome|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
341753|NCT01140061|O4|Outcome|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
341754|NCT01140061|O3|Outcome|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
341755|NCT01140061|O2|Outcome|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
341756|NCT01140061|O1|Outcome|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
341757|NCT01140061|O6|Outcome|Placebo - Pooled|In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis.
341758|NCT01140061|O5|Outcome|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
341759|NCT01140061|O4|Outcome|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
341760|NCT01140061|O3|Outcome|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
341761|NCT01140061|O2|Outcome|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
341762|NCT01140061|O1|Outcome|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
341763|NCT01140061|O5|Outcome|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
341764|NCT01140061|O4|Outcome|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
341765|NCT01140061|O3|Outcome|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
341766|NCT01140061|O2|Outcome|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
341767|NCT01140061|O1|Outcome|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
341768|NCT01140061|O2|Outcome|Panel A - Placebo|In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days.
341769|NCT01140061|O1|Outcome|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
341943|NCT01139515|O2|Outcome|Eletriptan 40 mg Tablet|Single oral dose of eletriptan 40 mg tablet (Treatment B).
341770|NCT01140061|E6|Reported Event|Placebo - Pooled|In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis.
341771|NCT01140061|E5|Reported Event|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
341772|NCT01140061|E4|Reported Event|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
341773|NCT01140061|E3|Reported Event|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
341774|NCT01140061|E2|Reported Event|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
341775|NCT01140061|E1|Reported Event|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
341776|NCT01140048|B1|Baseline|All Enrolled Participants|
341777|NCT01140048|P1|Participant Flow|All Enrolled Participants|
341778|NCT01140048|O1|Outcome|All Enrolled Participants|
341779|NCT01140048|O1|Outcome|All Enrolled Participants|
341780|NCT01140048|O1|Outcome|All Enrolled Participants|
341781|NCT01140048|E1|Reported Event|All Enrolled Participants|
341782|NCT01139996|B3|Baseline|Total|Total of all reporting groups
341783|NCT01139996|B2|Baseline|Comparator|"Placebo group will receive a placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final placebo tablet~Placebo: A placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final tablet"
341784|NCT01139996|B1|Baseline|Transdermal Clonidine/Oral Clonidine|"An oral loading dose of Clonidine 0.3 mg and placement of a Clonidine Transdermal system at a dose of 0.3 mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3 mg after 12 hours~Clonidine: An oral loading dose of Clonidine 0.3 mg and placement of Clonidine Transdermal system at a dose of 0.3-mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3mg after 12 hours"
341785|NCT01139996|P2|Participant Flow|Comparator|"Placebo group will receive a placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final placebo tablet~Placebo: A placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final tablet"
341786|NCT01139996|P1|Participant Flow|Transdermal Clonidine/Oral Clonidine|"An oral loading dose of Clonidine 0.3 mg and placement of a Clonidine Transdermal system at a dose of 0.3 mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3 mg after 12 hours~Clonidine: An oral loading dose of Clonidine 0.3 mg and placement of Clonidine Transdermal system at a dose of 0.3-mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3mg after 12 hours"
341787|NCT01139996|O2|Outcome|Comparator|"Placebo group will receive a placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final placebo tablet~Placebo: A placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final tablet"
341788|NCT01139996|O1|Outcome|Transdermal Clonidine/Oral Clonidine|"An oral loading dose of Clonidine 0.3 mg and placement of a Clonidine Transdermal system at a dose of 0.3 mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3 mg after 12 hours~Clonidine: An oral loading dose of Clonidine 0.3 mg and placement of Clonidine Transdermal system at a dose of 0.3-mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3mg after 12 hours"
341789|NCT01139996|E2|Reported Event|Comparator|"Placebo group will receive a placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final placebo tablet~Placebo: A placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final tablet"
341790|NCT01139996|E1|Reported Event|Transdermal Clonidine/Oral Clonidine|"An oral loading dose of Clonidine 0.3 mg and placement of a Clonidine Transdermal system at a dose of 0.3 mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3 mg after 12 hours~Clonidine: An oral loading dose of Clonidine 0.3 mg and placement of Clonidine Transdermal system at a dose of 0.3-mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3mg after 12 hours"
341791|NCT01139879|B1|Baseline|P400|"All patients will receive the P400 mattress~P400 mattress: The P400 mattress will be placed for a period of 12 weeks."
341792|NCT01139879|P1|Participant Flow|P400|"All patients will receive the P400 mattress~P400 mattress: The P400 mattress will be placed for a period of 12 weeks."
341793|NCT01139879|O1|Outcome|P400 Support Surface|All patients will receive the P400 mattress for a period of 12 weeks
341794|NCT01139879|O1|Outcome|P400|The P400 mattress will be placed for a period of 12 weeks for all enrolled patients
341795|NCT01139879|O1|Outcome|P400 Support Surface|"All patients will receive the P400 mattress~P400 mattress: The P400 mattress will be placed for a period of 12 weeks."
341796|NCT01139879|E1|Reported Event|P400 Support Surface|All patients will receive the P400 mattress for a period of 12 weeks
341797|NCT01139814|B1|Baseline|Intent-to-Treat|Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.
341798|NCT01139814|P1|Participant Flow|Intent-to-Treat|"Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.~Amigo RCS is an accessory for use in the cardiac EP setting to allow the operator to manipulate a steerable cardiac catheter and perform a conventional electrophysiology procedure. The intent of the device is to allow the operator to complete the procedure in a conventional x-ray guided EP lab. Catheter control can be performed while standing (or sitting) some distance from the subject to minimize absorbed radiology dose and minimize operator fatigue from standing for long periods of time with the standard lead aprons/personal protection devices."
341799|NCT01139814|O1|Outcome|Intent-to-Treat|Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.
352885|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
341800|NCT01139814|O1|Outcome|Intent-to-Treat|A subject was considered Intent-to-treat once the subject was evaluated for the study criteria on the day of procedure, the Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.
341801|NCT01139814|E1|Reported Event|Intent-to-Treat|Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.
341802|NCT01139775|B4|Baseline|Total|Total of all reporting groups
341803|NCT01139775|B3|Baseline|Phase 2: Pemetrexed + Cisplatin|"Cycles 1-4 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Day 1: pemetrexed 500 mg/m^2~Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour."
341804|NCT01139775|B2|Baseline|Phase 2: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-4 (21-day cycle):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
341805|NCT01139775|B1|Baseline|Phase 1: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-2 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 130 to 275 mg~After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
341806|NCT01139775|P3|Participant Flow|Phase 2: Pemetrexed + Cisplatin|"Cycles 1-4 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Day 1: pemetrexed 500 mg/m^2~Pemetrexed was administered IV over 10 minutes and cisplatin was administered IV over 1 hour."
341807|NCT01139775|P2|Participant Flow|Phase 2: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-4 (21-day cycle):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
341808|NCT01139775|P1|Participant Flow|Phase 1: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-2 (21-day cycle):~Day 1: pemetrexed 500 milligrams per square meter (mg/m^2) + cisplatin 75 mg/m^2~Day 2: LY2603618 130 to 275 milligrams (mg)~After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Pemetrexed, cisplatin, and LY2603618 were administered intravenously (IV) over 10 minutes, 1 hour, and 1 hour, respectively."
341809|NCT01139775|O2|Outcome|Phase 2: Pemetrexed + Cisplatin|"Cycles 1-4 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Day 1: pemetrexed 500 mg/m^2~Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour."
341810|NCT01139775|O1|Outcome|Phase 2: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-4 (21-day cycle):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
341811|NCT01139775|O2|Outcome|Phase 2: Pemetrexed + Cisplatin|"Cycles 1-4 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Day 1: pemetrexed 500 mg/m^2~Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour."
341812|NCT01139775|O1|Outcome|Phase 2: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-4 (21-day cycle):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
341944|NCT01139515|O1|Outcome|Eletriptan 20 mg Tablet|Single oral dose of eletriptan 20 mg tablet (Treatment A).
341813|NCT01139775|O3|Outcome|Phase 2: Pemetrexed + Cisplatin|"Cycles 1-4 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Day 1: pemetrexed 500 mg/m^2~Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour."
341814|NCT01139775|O2|Outcome|Phase 2: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-4 (21-day cycle):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
341815|NCT01139775|O1|Outcome|Phase 1: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-2 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 130 to 275 mg~After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
341816|NCT01139775|O1|Outcome|Phase 1: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-2 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 130 to 275 mg~After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
341817|NCT01139775|O2|Outcome|Phase 2: Pemetrexed + Cisplatin|"Cycles 1-4 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Day 1: pemetrexed 500 mg/m^2~Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour."
341818|NCT01139775|O1|Outcome|Phase 2: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-4 (21-day cycle):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
341819|NCT01139775|O1|Outcome|Phase 2: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-4 (21-day cycle):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
341820|NCT01139775|O1|Outcome|Phase 2: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-4 (21-day cycle):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
341821|NCT01139775|O1|Outcome|Phase 1: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-2 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 130 to 275 mg~After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
341822|NCT01139775|O1|Outcome|Phase 1: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-2 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 130 to 275 mg~After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
341823|NCT01139775|O1|Outcome|Phase 1: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-2 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 130 to 275 mg~After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
341824|NCT01139775|O1|Outcome|Phase 1: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-2 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 130 to 275 mg~After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
341825|NCT01139775|O2|Outcome|Phase 2: Pemetrexed + Cisplatin|"Cycles 1-4 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Day 1: pemetrexed 500 mg/m^2~Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour."
341826|NCT01139775|O1|Outcome|Phase 2: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-4 (21-day cycle):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
341827|NCT01139775|O2|Outcome|Phase 2: Pemetrexed + Cisplatin|"Cycles 1-4 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Day 1: pemetrexed 500 mg/m^2~Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour."
341828|NCT01139775|O1|Outcome|Phase 2: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-4 (21-day cycle):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
341829|NCT01139775|O2|Outcome|Phase 2: Pemetrexed + Cisplatin|"Cycles 1-4 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Day 1: pemetrexed 500 mg/m^2~Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour."
341830|NCT01139775|O1|Outcome|Phase 2: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-4 (21-day cycle):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
341831|NCT01139775|O1|Outcome|Phase 1: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-2 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 130 to 275 mg~After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
341832|NCT01139775|O2|Outcome|Phase 2: Pemetrexed + Cisplatin|"Cycles 1-4 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Day 1: pemetrexed 500 mg/m^2~Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour."
341833|NCT01139775|O1|Outcome|Phase 2: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-4 (21-day cycle):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
341834|NCT01139775|E3|Reported Event|Phase 2: Pemetrexed + Cisplatin|"Cycles 1-4 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Day 1: pemetrexed 500 mg/m^2~Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour."
341873|NCT01139762|E1|Reported Event|Screening-Washout and Placebo Lead-In|4 weeks washout period and followed by placebo orally, once daily for 4 weeks during placebo lead-in period.
341874|NCT01139658|B3|Baseline|Total|Total of all reporting groups
341875|NCT01139658|B2|Baseline|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341876|NCT01139658|B1|Baseline|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
352886|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
341835|NCT01139775|E2|Reported Event|Phase 2: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-4 (21-day cycle):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Maintenance therapy (every 21 days):~Before 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~Day 2: LY2603618 dose determined from phase 1 (275 mg)~After 25 Oct 2012:~Day 1: pemetrexed 500 mg/m^2~If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
341836|NCT01139775|E1|Reported Event|Phase 1: Pemetrexed + Cisplatin + LY2603618|"Cycles 1-2 (21-day cycle):~Day 1: pemetrexed 500 mg/m^2 + cisplatin 75 mg/m^2~Day 2: LY2603618 130 to 275 mg~After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met.~Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively."
341837|NCT01139762|B3|Baseline|Total|Total of all reporting groups
341838|NCT01139762|B2|Baseline|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341839|NCT01139762|B1|Baseline|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341840|NCT01139762|P3|Participant Flow|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
341841|NCT01139762|P2|Participant Flow|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
341842|NCT01139762|P1|Participant Flow|Screening-Washout and Placebo Lead-In|4 weeks washout period and followed by placebo orally, once daily for 4 weeks during placebo lead-in period.
341843|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341844|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341845|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341846|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341847|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341848|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341849|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341850|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341851|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341852|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341853|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341854|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341855|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341856|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341857|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341858|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341859|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341860|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341861|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341862|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341863|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341864|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341865|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341866|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341867|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341868|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341869|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341870|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
341871|NCT01139762|E3|Reported Event|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
341872|NCT01139762|E2|Reported Event|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
341877|NCT01139658|P2|Participant Flow|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341878|NCT01139658|P1|Participant Flow|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341879|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341880|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341881|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341882|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341883|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341884|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341885|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341886|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341887|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341888|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341889|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341890|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341891|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341892|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341893|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341894|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341895|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341896|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341897|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341898|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341899|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341900|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341901|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341902|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341903|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341904|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341905|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341906|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341942|NCT01139515|O3|Outcome|Eletriptan 80 mg Tablet|Single oral dose of two eletriptan 40 mg tablets (Treatment C).
341907|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341908|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341909|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341910|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341911|NCT01139658|E2|Reported Event|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341912|NCT01139658|E1|Reported Event|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
341913|NCT01139580|B3|Baseline|Total|Total of all reporting groups
341914|NCT01139580|B2|Baseline|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
341915|NCT01139580|B1|Baseline|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
341916|NCT01139580|P2|Participant Flow|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
341917|NCT01139580|P1|Participant Flow|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body twice daily (BD) for 8 weeks.
341918|NCT01139580|O2|Outcome|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
341919|NCT01139580|O1|Outcome|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
341920|NCT01139580|O2|Outcome|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
341921|NCT01139580|O1|Outcome|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
341922|NCT01139580|O2|Outcome|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
341923|NCT01139580|O1|Outcome|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
341924|NCT01139580|O2|Outcome|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
341925|NCT01139580|O1|Outcome|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
341926|NCT01139580|O2|Outcome|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
341927|NCT01139580|O1|Outcome|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
341928|NCT01139580|O2|Outcome|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
341929|NCT01139580|O1|Outcome|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
341930|NCT01139580|E2|Reported Event|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
341931|NCT01139580|E1|Reported Event|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
341932|NCT01139515|B1|Baseline|Entire Study Population|All participants randomized to any treatment (Eletriptan 20 mg tablet first, eletriptan 40 mg tablet first, eletriptan 80 mg tablet first, and eletriptan 40 mg 2 hrs apart repeated dose (80 mg in total).
341933|NCT01139515|P4|Participant Flow|Eletriptan 40 mg 2 Hrs Apart Repeated Dose,20 mg,80 mg,40 mg|Two oral doses of 40 mg eletriptan tablet administered 2 hrs apart tablet in first intervention period; followed by single oral dose of eletriptan 20 mg in second intervention period; then single oral dose of eletriptan 80 mg tablet in third intervention period; and single oral dose of eletriptan 40 mg tablet in fourth intervention period. A washout period of 46 hrs was maintained between each period.
341934|NCT01139515|P3|Participant Flow|Eletriptan 80 mg,40 mg 2 Hrs Apart Repeated Dose,40 mg,20 mg|Single oral dose of eletriptan 80 mg tablet in first intervention period; followed by two oral doses of 40 mg eletriptan tablet administered 2 hrs apart in second intervention period; then single oral dose of eletriptan 40 mg tablet in third intervention period; and single oral dose of eletriptan 20 mg tablet in fourth intervention period. A washout period of 46 hrs was maintained between each period.
341935|NCT01139515|P2|Participant Flow|Eletriptan 40 mg,80 mg,20 mg,40 mg 2 Hrs Apart Repeated Dose|Single oral dose of eletriptan 40 mg tablet in first intervention period; followed by single oral dose of eletriptan 80 mg tablet in second intervention period; then single oral dose of eletriptan 20 mg tablet in third intervention period; and two oral doses of 40 mg eletriptan tablet administered 2 hrs apart in fourth intervention period. A washout period of 46 hrs was maintained between each period.
341936|NCT01139515|P1|Participant Flow|Eletriptan 20 mg,40 mg,80 mg,40 mg 2 Hrs Apart Repeated Dose|Single oral dose of eletriptan 20 mg tablet in first intervention period; followed by single oral dose of eletriptan 40 mg tablet in second intervention period; then single oral dose of eletriptan 80 mg tablet in third intervention period; and two oral doses of 40 mg eletriptan tablet administered 2 hrs apart in fourth intervention period. A washout period of 46 hrs was maintained between each period.
341937|NCT01139515|O4|Outcome|Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose|Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
341938|NCT01139515|O3|Outcome|Eletriptan 80 mg Tablet|Single oral dose of two eletriptan 40 mg tablets (Treatment C).
341939|NCT01139515|O2|Outcome|Eletriptan 40 mg Tablet|Single oral dose of eletriptan 40 mg tablet (Treatment B).
341940|NCT01139515|O1|Outcome|Eletriptan 20 mg Tablet|Single oral dose of eletriptan 20 mg tablet (Treatment A).
341941|NCT01139515|O4|Outcome|Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose|Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
341945|NCT01139515|O4|Outcome|Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose|Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
341946|NCT01139515|O3|Outcome|Eletriptan 80 mg Tablet|Single oral dose of two eletriptan 40 mg tablets (Treatment C).
341947|NCT01139515|O2|Outcome|Eletriptan 40 mg Tablet|Single oral dose of eletriptan 40 mg tablet (Treatment B).
341948|NCT01139515|O1|Outcome|Eletriptan 20 mg Tablet|Single oral dose of eletriptan 20 mg tablet (Treatment A).
341949|NCT01139515|O4|Outcome|Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose|Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
341950|NCT01139515|O3|Outcome|Eletriptan 80 mg Tablet|Single oral dose of two eletriptan 40 mg tablets (Treatment C).
341951|NCT01139515|O2|Outcome|Eletriptan 40 mg Tablet|Single oral dose of eletriptan 40 mg tablet (Treatment B).
341952|NCT01139515|O1|Outcome|Eletriptan 20 mg Tablet|Single oral dose of eletriptan 20 mg tablet (Treatment A).
341953|NCT01139515|O4|Outcome|Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose|Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
341954|NCT01139515|O3|Outcome|Eletriptan 80 mg Tablet|Single oral dose of two eletriptan 40 mg tablets (Treatment C).
341955|NCT01139515|O2|Outcome|Eletriptan 40 mg Tablet|Single oral dose of eletriptan 40 mg tablet (Treatment B).
341956|NCT01139515|O1|Outcome|Eletriptan 20 mg Tablet|Single oral dose of eletriptan 20 mg tablet (Treatment A).
341957|NCT01139515|E4|Reported Event|Eletriptan 40 mg 2 Hrs Apart Repeated Dose|Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
341958|NCT01139515|E3|Reported Event|Eletriptan 80 mg Tablet|Single oral dose of two eletriptan 40 mg tablets (Treatment C).
341959|NCT01139515|E2|Reported Event|Eletriptan 40 mg Tablet|Single oral dose of eletriptan 40 mg tablet (Treatment B).
341960|NCT01139515|E1|Reported Event|Eletriptan 20 mg Tablet|Single oral dose of eletriptan 20 mg tablet (Treatment A).
341961|NCT01139450|B4|Baseline|Total|Total of all reporting groups
341962|NCT01139450|B3|Baseline|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks"
341963|NCT01139450|B2|Baseline|Reference|"Reference product that contains the active pharmaceutical ingredient~Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks"
341964|NCT01139450|B1|Baseline|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks"
341965|NCT01139450|P3|Participant Flow|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks"
341966|NCT01139450|P2|Participant Flow|Reference|"Reference product that contains the active pharmaceutical ingredient~Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks"
341967|NCT01139450|P1|Participant Flow|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks"
341968|NCT01139450|O3|Outcome|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks"
341969|NCT01139450|O2|Outcome|Reference|"Reference product that contains the active pharmaceutical ingredient~Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks"
341970|NCT01139450|O1|Outcome|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks"
341971|NCT01139450|E3|Reported Event|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks"
341972|NCT01139450|E2|Reported Event|Reference|"Reference product that contains the active pharmaceutical ingredient~Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks"
341973|NCT01139450|E1|Reported Event|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks"
341974|NCT01139411|B3|Baseline|Total|Total of all reporting groups
341975|NCT01139411|B2|Baseline|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
341976|NCT01139411|B1|Baseline|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
341977|NCT01139411|P2|Participant Flow|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
341978|NCT01139411|P1|Participant Flow|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
341979|NCT01139411|O2|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
341980|NCT01139411|O1|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
341981|NCT01139411|O2|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
341982|NCT01139411|O1|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
342905|NCT01136785|B2|Baseline|Sham CPAP|7 days of sham CPAP in the laboratory.
341983|NCT01139411|O2|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
341984|NCT01139411|O1|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
341985|NCT01139411|O2|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
341986|NCT01139411|O1|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
341987|NCT01139411|O2|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
341988|NCT01139411|O1|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
341989|NCT01139411|O2|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
341990|NCT01139411|O1|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
341991|NCT01139411|O2|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
341992|NCT01139411|O1|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
341993|NCT01139411|E2|Reported Event|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
341994|NCT01139411|E1|Reported Event|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
341995|NCT01139294|B3|Baseline|Total|Total of all reporting groups
341996|NCT01139294|B2|Baseline|Hylenex|"1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours~Hylenex: 1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours"
341997|NCT01139294|B1|Baseline|Standard of Care IV Therapy|control arm of the study
341998|NCT01139294|P2|Participant Flow|Hylenex|"1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours~Hylenex: 1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours"
341999|NCT01139294|P1|Participant Flow|Standard of Care IV Therapy|control arm of the study
342000|NCT01139294|O2|Outcome|Hylenex|"1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours~Hylenex: 1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours"
342001|NCT01139294|O1|Outcome|Standard of Care IV Therapy|control arm of the study
342002|NCT01139294|O2|Outcome|Hylenex|"1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours~Hylenex: 1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours"
342003|NCT01139294|O1|Outcome|Standard of Care IV Therapy|control arm of the study
342004|NCT01139294|E2|Reported Event|Hylenex|"1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours~Hylenex: 1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours"
342005|NCT01139294|E1|Reported Event|Standard of Care IV Therapy|control arm of the study
342006|NCT01139190|B3|Baseline|Total|Total of all reporting groups
342007|NCT01139190|B2|Baseline|Naproxen|Subjects were to take 500 mg of Naproxen (two 250 mg tablets) of study drug twice a day for a total duration of 14.5 days.
342008|NCT01139190|B1|Baseline|PL3100|Subjects were to take 500 mg of PL3100 (two 250 mg capsules) of study drug twice a day for a total duration of 14.5 days.
342009|NCT01139190|P2|Participant Flow|Naproxen|Subjects were to take 500 mg of Naproxen (two 250 mg tablets) of study drug twice a day for a total duration of 14.5 days.
342010|NCT01139190|P1|Participant Flow|PL3100|Subjects were to take 500 mg of PL3100 (two 250 mg capsules) of study drug twice a day for a total duration of 14.5 days.
342011|NCT01139190|O2|Outcome|Naproxen|Naproxen: Oral administration
342012|NCT01139190|O1|Outcome|PL3100|PL3100: Oral administration
342013|NCT01139190|E2|Reported Event|Naproxen|Naproxen: Oral administration
342014|NCT01139190|E1|Reported Event|PL3100|PL3100: Oral administration
342015|NCT01139164|B4|Baseline|Total|Total of all reporting groups
342016|NCT01139164|B3|Baseline|Group 3: Regimen C|B-Cell Lymphomas
342017|NCT01139164|B2|Baseline|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
342018|NCT01139164|B1|Baseline|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
342019|NCT01139164|P3|Participant Flow|Group 3: Regimen C|B-Cell Lymphomas
342020|NCT01139164|P2|Participant Flow|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
342124|NCT01138969|O1|Outcome|Esomeprazole Plus Clopidogrel Group|esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
342021|NCT01139164|P1|Participant Flow|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
342022|NCT01139164|O3|Outcome|Group 3: Regimen C|B-Cell Lymphomas
342023|NCT01139164|O2|Outcome|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
342024|NCT01139164|O1|Outcome|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
342025|NCT01139164|O3|Outcome|Group 3: Regimen C|B-Cell Lymphomas
342026|NCT01139164|O2|Outcome|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
342027|NCT01139164|O1|Outcome|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
342028|NCT01139164|O3|Outcome|Group 3: Regimen C|B-Cell Lymphomas
342029|NCT01139164|O2|Outcome|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
342030|NCT01139164|O1|Outcome|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
342031|NCT01139164|E3|Reported Event|Group 3: Regimen C|B-Cell Lymphomas
342032|NCT01139164|E2|Reported Event|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
342033|NCT01139164|E1|Reported Event|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
342034|NCT01139125|B1|Baseline|Cystagon|One black male and two white males started the study
342035|NCT01139125|P1|Participant Flow|Cystagon (Cysteamine Bitartrate)|Subjects were expected to take cystagon (cysteamine bitarate)14 capsules per day (4 at 7:00 am, 3 at 12:00 pm, 4 at 5:00 pm and 3 at 10:00pm) for 16 weeks.
342036|NCT01139125|O1|Outcome|Cystagon|Subjects are required to take 14 capsules per day for 16 weeks
342037|NCT01139125|E1|Reported Event|Cystagon|Subjects taking 14 capsules per day for 16 weeks
342038|NCT01139047|B1|Baseline|MetroGel® 1% and Finacea® Gel 15%|This was a randomized split-face study where MetroGel®(metronidazole gel) 1% was applied topically to one side of the face once daily for 3 weeks and Finacea® (azelaic acid) gel 15% was applied to the opposite side of the face twice daily for 3 weeks
342039|NCT01139047|P1|Participant Flow|MetroGel® 1% and Finacea® Gel 15%|This was a randomized split-face study where MetroGel®(metronidazole gel) 1% was applied topically to one side of the face once daily for 3 weeks and Finacea® (azelaic acid) gel 15% was applied to the opposite side of the face twice daily for 3 weeks
342040|NCT01139047|O1|Outcome|MetroGel® 1% and Finacea Gel® 15%|This was a randomized split-face study where metronidazole 1% gel was applied to one side of the face once daily for 3 weeks and azelaic acid 15 % gel was applied to the opposite side of the face twice daily for 3 weeks
342041|NCT01139047|O2|Outcome|Finacea Gel® 15%|azelaic acid 15 % gel - apply topically to the opposite side of the face twice daily for 3 weeks
342042|NCT01139047|O1|Outcome|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
342043|NCT01139047|O2|Outcome|Finacea Gel® 15%|azelaic acid 15 % gel - apply topically to the opposite side of the face twice daily for 3 weeks
342044|NCT01139047|O1|Outcome|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
342045|NCT01139047|E2|Reported Event|Finacea® Gel 15%|azelaic acid gel 15% - apply topically to the opposite side of the face twice daily for 3 weeks
342046|NCT01139047|E1|Reported Event|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
342047|NCT01139021|B7|Baseline|Total|Total of all reporting groups
342048|NCT01139021|B6|Baseline|B12M13|Subject was randomized in group B13_15_27 but treated as group B12_M13.
342049|NCT01139021|B5|Baseline|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
342050|NCT01139021|B4|Baseline|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
342051|NCT01139021|B3|Baseline|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
342052|NCT01139021|B2|Baseline|B246_12M13|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.
342053|NCT01139021|B1|Baseline|B246_12M12|Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
342054|NCT01139021|P6|Participant Flow|B12M13|Subject was randomized in group B13_15_27 but treated as group B12_M13.
342055|NCT01139021|P5|Participant Flow|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
342056|NCT01139021|P4|Participant Flow|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
342057|NCT01139021|P3|Participant Flow|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
342058|NCT01139021|P2|Participant Flow|B246_12M13|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.
342059|NCT01139021|P1|Participant Flow|B246_12M12|Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
342060|NCT01139021|O1|Outcome|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
342061|NCT01139021|O1|Outcome|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
342062|NCT01139021|O2|Outcome|B12_14_26|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 12 and 14 months of age.
342063|NCT01139021|O1|Outcome|B13_15_27|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 13 and 15 months of age.
342064|NCT01139021|O2|Outcome|B12_14_26|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 12 and 14 months of age.
342065|NCT01139021|O1|Outcome|B13_15_27|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 13 and 15 months of age.
342066|NCT01139021|O1|Outcome|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
342067|NCT01139021|O1|Outcome|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
342068|NCT01139021|O1|Outcome|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
342069|NCT01139021|O1|Outcome|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
342070|NCT01139021|O3|Outcome|B12+B13Tot|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 13th and 15th months or 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27th or 26th months of age.
342071|NCT01139021|O2|Outcome|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
342072|NCT01139021|O1|Outcome|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
342073|NCT01139021|O3|Outcome|B12+B13Tot|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 13th and 15th months or 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27th or 26th months of age.
342074|NCT01139021|O2|Outcome|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
342075|NCT01139021|O1|Outcome|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
342076|NCT01139021|O3|Outcome|B12+B13Tot|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 13th and 15th months or 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27th or 26th months of age.
342077|NCT01139021|O2|Outcome|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
342078|NCT01139021|O1|Outcome|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
342079|NCT01139021|O3|Outcome|B12+B13Tot|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 13th and 15th months or 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27th or 26th months of age.
342080|NCT01139021|O2|Outcome|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
342081|NCT01139021|O1|Outcome|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
342082|NCT01139021|O3|Outcome|B246_12Tot|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
342083|NCT01139021|O2|Outcome|B246_12M13|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.
342084|NCT01139021|O1|Outcome|B246_12M12|Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
342085|NCT01139021|O3|Outcome|B246_12Tot|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
342086|NCT01139021|O2|Outcome|B246_12M13|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age
342087|NCT01139021|O1|Outcome|B246_12M12|Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
342088|NCT01139021|O3|Outcome|B246_12Tot|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
342089|NCT01139021|O2|Outcome|B246_12M13|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.
342090|NCT01139021|O1|Outcome|B246_12M12|Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
342091|NCT01139021|E3|Reported Event|B24_26|Subjects assessed for safety and tolerability after two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
342092|NCT01139021|E2|Reported Event|B12_14_26|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at either 12 and 14 months of age.
342093|NCT01139021|E1|Reported Event|B13_15_27|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 13 and 15 months of age.
342094|NCT01139008|B1|Baseline|MetroGel® 1% and Finacea® Gel 15%|This was a randomized split-face study where metronidazole gel 1% was applied topically to one side of the face once daily for 3 weeks and azelaic acid gel 15% was applied to the opposite side of the face twice daily for 3 weeks
342095|NCT01139008|P1|Participant Flow|MetroGel® 1% and Finacea 15%|This was a randomized split-face study where metronidazole gel 1% was applied topically to one side of the face once daily for 3 weeks and azelaic acid gel 15% was applied to the opposite side of the face twice daily for 3 weeks
342096|NCT01139008|O1|Outcome|MetroGel® 1% and Finacea® Gel 15%|This is a split-face study where metronidazole gel 1% was applied topically to one side of the face once daily for 3 weeks and azelaic acid 15% gel was applied topically to the opposite side of the face twice daily for 3 weeks
342097|NCT01139008|O2|Outcome|Finacea® Gel 15%|azelaic acid gel 15% - apply topically twice daily to the opposite side of the face
342098|NCT01139008|O1|Outcome|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
342099|NCT01139008|O2|Outcome|Finacea® Gel 15%|azelaic acid gel 15% - apply topically twice daily to the opposite side of the face
342100|NCT01139008|O1|Outcome|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
342101|NCT01139008|E2|Reported Event|Finacea® Gel 15%|azelaic acid gel 15% - apply topically twice daily to the opposite side of the face
342102|NCT01139008|E1|Reported Event|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
342103|NCT01138995|B3|Baseline|Total|Total of all reporting groups
342104|NCT01138995|B2|Baseline|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 42 weeks.~Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.~Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a usual ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks."
342105|NCT01138995|B1|Baseline|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO)for 30 weeks. After 30 weeks, the Original Control Group will then be crossed over to walk with the Ness L300 for a total of 12 weeks.~Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.~Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a usual ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks."
342106|NCT01138995|P2|Participant Flow|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 42 weeks.~Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.~Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a usual ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks."
342107|NCT01138995|P1|Participant Flow|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO)for 30 weeks. After 30 weeks, the Original Control Group will then be crossed over to walk with the Ness L300 for a total of 12 weeks.~Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.~Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a usual ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks."
342108|NCT01138995|O2|Outcome|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 30 weeks.~The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke."
342109|NCT01138995|O1|Outcome|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO)for 30 weeks."
342110|NCT01138995|O2|Outcome|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 30 weeks.~Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke."
342111|NCT01138995|O1|Outcome|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO)for 30 weeks."
342112|NCT01138995|O2|Outcome|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 30 weeks.~The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke."
342113|NCT01138995|O1|Outcome|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO)for 30 weeks."
342114|NCT01138995|E2|Reported Event|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 30 weeks.~The Ness L300 delivers functional electrical stimulation (FES), is intended to improve gait function, stroke-specific quality of life, functionality, and safety for persons with stroke."
342115|NCT01138995|E1|Reported Event|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO) for 30 weeks."
342116|NCT01138969|B3|Baseline|Total|Total of all reporting groups
342117|NCT01138969|B2|Baseline|Clopidogrel Group|clopidogrel 75 mg qd for 6 months
342118|NCT01138969|B1|Baseline|Esomeprazole Plus Clopidogrel Group|esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
342119|NCT01138969|P2|Participant Flow|Clopidogrel Group|clopidogrel 75 mg qd for 6 months
342120|NCT01138969|P1|Participant Flow|Esomeprazole Plus Clopidogrel Group|esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
342121|NCT01138969|O2|Outcome|Clopidogrel Group|clopidogrel 75 mg qd for 6 months
342122|NCT01138969|O1|Outcome|Esomeprazole Plus Clopidogrel Group|esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
342123|NCT01138969|O2|Outcome|Clopidogrel Group|clopidogrel 75 mg qd for 6 months
342126|NCT01138969|E1|Reported Event|Esomeprazole Plus Clopidogrel Group|esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
342127|NCT01138826|B1|Baseline|Entire Study Population|All participants randomized to any treatment.(Amlodipine tablet first, amlodipine ODT first, and amlodipine ODT without water first).
342128|NCT01138826|P6|Participant Flow|Amlodipine ODT Without Water,Amlodipine ODT,Amlodipine Tablet|Single oral dose amlodipine 10 mg ODT without water in first intervention period; followed by single oral dose of amlodipine 10 mg ODT in second intervention period; and single oral dose of amlodipine 10 mg tablet in third intervention period. A washout period of 16 days was maintained between each period.
342129|NCT01138826|P5|Participant Flow|Amlodipine ODT Without Water,Amlodipine Tablet,Amlodipine ODT|Single oral dose amlodipine 10 mg ODT without water in first intervention period; followed by single oral dose of amlodipine 10 mg tablet in second intervention period; and single oral dose of amlodipine 10 mg ODT in third intervention period. A washout period of 16 days was maintained between each period.
342130|NCT01138826|P4|Participant Flow|Amlodipine ODT,Amlodipine Tablet,Amlodipine ODT Without Water|Single oral dose amlodipine 10 mg ODT in first intervention period; followed by single oral dose of amlodipine 10 mg tablet in second intervention period; and single oral dose of amlodipine 10 mg ODT without water in third intervention period. A washout period of 16 days was maintained between each period.
342131|NCT01138826|P3|Participant Flow|Amlodipine ODT,Amlodipine ODT Without Water,Amlodipine Tablet|Single oral dose amlodipine 10 mg ODT in first intervention period; followed by single oral dose of amlodipine 10 mg ODT without water in second intervention period; and single oral dose of amlodipine 10 mg tablet in third intervention period. A washout period of 16 days was maintained between each period.
342132|NCT01138826|P2|Participant Flow|Amlodipine Tablet,Amlodipine ODT Without Water,Amlodipine ODT|Single oral dose amlodipine 10 mg tablet in first intervention period; followed by single oral dose of amlodipine 10 mg ODT without water in second intervention period; and single oral dose of amlodipine 10 mg ODT in third intervention period. A washout period of 16 days was maintained between each period.
342133|NCT01138826|P1|Participant Flow|Amlodipine Tablet,Amlodipine ODT,Amlodipine ODT Without Water|Single oral dose amlodipine 10 mg tablet in first intervention period; followed by single oral dose of amlodipine 10 mg oral disintegrating tablet (ODT) in second intervention period; and single oral dose of amlodipine 10 mg ODT without water in third intervention period. A washout period of 16 days was maintained between each period.
342134|NCT01138826|O3|Outcome|Amlodipine 10 mg ODT Without Water (Test Product C)|Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
342135|NCT01138826|O2|Outcome|Amlodipine 10 mg ODT With Water (Test Product B)|Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
342136|NCT01138826|O1|Outcome|Amlodipine 10mg Tablet With Water (Reference Product A)|Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
342137|NCT01138826|O3|Outcome|Amlodipine 10 mg ODT Without Water (Test Product C)|Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
342138|NCT01138826|O2|Outcome|Amlodipine 10 mg ODT With Water (Test Product B)|Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
342139|NCT01138826|O1|Outcome|Amlodipine 10mg Tablet With Water (Reference Product A)|Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
342140|NCT01138826|O3|Outcome|Amlodipine 10 mg ODT Without Water (Test Product C)|Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
342141|NCT01138826|O2|Outcome|Amlodipine 10 mg ODT With Water (Test Product B)|Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
342165|NCT01138735|E2|Reported Event|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
342166|NCT01138735|E1|Reported Event|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
342142|NCT01138826|O1|Outcome|Amlodipine 10mg Tablet With Water (Reference Product A)|Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
342143|NCT01138826|O3|Outcome|Amlodipine 10 mg ODT Without Water (Test Product C)|Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
342144|NCT01138826|O2|Outcome|Amlodipine 10 mg ODT With Water (Test Product B)|Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
342145|NCT01138826|O1|Outcome|Amlodipine 10mg Tablet With Water (Reference Product A)|Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
342146|NCT01138826|O3|Outcome|Amlodipine 10 mg ODT Without Water (Test Product C)|Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
342147|NCT01138826|O2|Outcome|Amlodipine 10 mg ODT With Water (Test Product B)|Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
342148|NCT01138826|O1|Outcome|Amlodipine 10mg Tablet With Water (Reference Product A)|Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
342149|NCT01138826|E3|Reported Event|Amlodipine 10 mg ODT Without Water (Test Product C)|Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
342150|NCT01138826|E2|Reported Event|Amlodipine 10 mg ODT With Water (Test Product B)|Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
342151|NCT01138826|E1|Reported Event|Amlodipine 10mg Tablet With Water (Reference Product A)|Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
342152|NCT01138735|B3|Baseline|Total|Total of all reporting groups
342153|NCT01138735|B2|Baseline|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
342154|NCT01138735|B1|Baseline|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
342155|NCT01138735|P2|Participant Flow|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
342156|NCT01138735|P1|Participant Flow|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
342157|NCT01138735|O2|Outcome|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
342158|NCT01138735|O1|Outcome|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
342159|NCT01138735|O2|Outcome|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
342160|NCT01138735|O1|Outcome|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
342161|NCT01138735|O2|Outcome|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
342162|NCT01138735|O1|Outcome|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
342163|NCT01138735|O2|Outcome|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
342164|NCT01138735|O1|Outcome|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
342168|NCT01138657|B2|Baseline|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342169|NCT01138657|B1|Baseline|Placebo|Participants received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342170|NCT01138657|P2|Participant Flow|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342171|NCT01138657|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection at Baseline followed by every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342172|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342173|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342174|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342175|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342176|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342177|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342178|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342179|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342180|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342181|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342182|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342183|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342184|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342231|NCT01138514|E2|Reported Event|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
342579|NCT01137773|O2|Outcome|Convention Insulin Treatment|conventional (150–170 mg/dl, n = 20) glucose control
342185|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342186|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342187|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342188|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342189|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342190|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342191|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342192|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342193|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342194|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342195|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342196|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342197|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342198|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342199|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342200|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342201|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342202|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342203|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342204|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342205|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342206|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342207|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342208|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342209|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342210|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342211|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342212|NCT01138657|E2|Reported Event|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342213|NCT01138657|E1|Reported Event|Placebo|Participants received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
342214|NCT01138514|B4|Baseline|Total|Total of all reporting groups
342215|NCT01138514|B3|Baseline|Vehicle|Placebo: Placebo
342216|NCT01138514|B2|Baseline|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
342217|NCT01138514|B1|Baseline|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
342218|NCT01138514|P3|Participant Flow|Vehicle|Placebo: Placebo
342219|NCT01138514|P2|Participant Flow|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
342220|NCT01138514|P1|Participant Flow|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
342221|NCT01138514|O3|Outcome|Vehicle|Placebo
342222|NCT01138514|O2|Outcome|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
342223|NCT01138514|O1|Outcome|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
342224|NCT01138514|O3|Outcome|Vehicle|Placebo: Placebo
342225|NCT01138514|O2|Outcome|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
342226|NCT01138514|O1|Outcome|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
342227|NCT01138514|O3|Outcome|Vehicle|Placebo: Placebo
342228|NCT01138514|O2|Outcome|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
342229|NCT01138514|O1|Outcome|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
342230|NCT01138514|E3|Reported Event|Vehicle|Placebo: Placebo
342580|NCT01137773|O1|Outcome|Intensive IV Insulin|Patients will receive IV insulin to maintain target glucose levels of 80-110 mg/dl
342232|NCT01138514|E1|Reported Event|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
342233|NCT01138501|B1|Baseline|All Subjects Treated With Turoctocog Alfa|The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa.
342234|NCT01138501|P1|Participant Flow|All Subjects Treated With Turoctocog Alfa|The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa.
342235|NCT01138501|O1|Outcome|All Subjects Treated With Turoctocog Alfa|The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa.
342236|NCT01138501|O1|Outcome|All Subjects Treated With Turoctocog Alfa|The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa.
342237|NCT01138501|E1|Reported Event|All Subjects Treated With Turoctocog Alfa|The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa.
342238|NCT01138475|B4|Baseline|Total|Total of all reporting groups
342239|NCT01138475|B3|Baseline|Placebo|
342240|NCT01138475|B2|Baseline|Cholecalciferol|
342241|NCT01138475|B1|Baseline|Paricalcitol|
342242|NCT01138475|P3|Participant Flow|Cholecalciferol|"The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.~This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively)."
342243|NCT01138475|P2|Participant Flow|Paricalcitrol|Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
342244|NCT01138475|P1|Participant Flow|Placebo-controlled|"The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).~Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL."
342245|NCT01138475|O3|Outcome|Placebo-controlled|"The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).~Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL."
342246|NCT01138475|O2|Outcome|Cholecalciferol|"The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.~This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively)."
342247|NCT01138475|O1|Outcome|Paricalcitrol|Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
342280|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
342281|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
342248|NCT01138475|O3|Outcome|Placebo-controlled|"The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).~Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL."
342249|NCT01138475|O2|Outcome|Cholecalciferol|"The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.~This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively)."
342250|NCT01138475|O1|Outcome|Paricalcitrol|Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
342251|NCT01138475|O3|Outcome|Placebo-controlled|"The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).~Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL."
342252|NCT01138475|O2|Outcome|Cholecalciferol|"The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.~This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively)."
342253|NCT01138475|O1|Outcome|Paricalcitrol|Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
342254|NCT01138475|O3|Outcome|Placebo-controlled|"The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).~Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL."
342255|NCT01138475|O2|Outcome|Cholecalciferol|"The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.~This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively)."
342256|NCT01138475|O1|Outcome|Paricalcitrol|Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
342257|NCT01138475|O3|Outcome|Placebo-controlled|"The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).~Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL."
342258|NCT01138475|O2|Outcome|Cholecalciferol|"The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.~This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively)."
342259|NCT01138475|O1|Outcome|Paricalcitrol|Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
342260|NCT01138475|O3|Outcome|Placebo-controlled|"The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).~Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL."
342261|NCT01138475|O2|Outcome|Cholecalciferol|"The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.~This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively)."
342262|NCT01138475|O1|Outcome|Paricalcitrol|Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
342263|NCT01138475|O3|Outcome|Placebo-controlled|"The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).~Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL."
342264|NCT01138475|O2|Outcome|Cholecalciferol|"The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.~This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively)."
342265|NCT01138475|O1|Outcome|Paricalcitrol|Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
342266|NCT01138475|O3|Outcome|Placebo|"This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program will be sufficient to enroll approximately 75 subjects (25 per treatment group).~Placebo: Inactive substance, one capsule daily for 6 weeks"
342267|NCT01138475|O2|Outcome|Cholecalciferol|"This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program will be sufficient to enroll approximately 75 subjects (25 per treatment group).~Cholecalciferol: 5000 IU (international units) by mouth daily for 6 weeks"
342268|NCT01138475|O1|Outcome|Paricalcitol|"This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules,cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program will be sufficient to enroll approximately 75 subjects (25 per treatment group).~Paricalcitol: 1 microgram by mouth daily for 6 weeks"
342269|NCT01138475|O3|Outcome|Placebo|"This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program~Placebo: Inactive substance, one capsule daily for 6 weeks"
342270|NCT01138475|O2|Outcome|Cholecalciferol|"This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program~Cholecalciferol: 5000 IU (international units) by mouth daily for 6 weeks"
342271|NCT01138475|O1|Outcome|Paricalcitol|"This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules,cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program~Paricalcitol: 1 microgram by mouth daily for 6 weeks"
342272|NCT01138475|E3|Reported Event|Placebo|Placebo capsules, one a day 7 days per week
342273|NCT01138475|E2|Reported Event|Cholecalciferol|cholecalciferol 5000 units per day, 7 days per week
342274|NCT01138475|E1|Reported Event|Paricalcitriol|Paricalcitriol 1 mcg per day 7 days per week
342275|NCT01138150|B3|Baseline|Total|Total of all reporting groups
342276|NCT01138150|B2|Baseline|Sugar Pill|Participants randomized to placebo (sugar pill) during acute migraine attack.
342277|NCT01138150|B1|Baseline|Treximet|Participants randomized to active drug Treximet during acute migraine attack.
342278|NCT01138150|P2|Participant Flow|Placebo|Participants randomized to placebo upon presentation with acute migraine attack.
342279|NCT01138150|P1|Participant Flow|Active Drug - Sumatriptan/Naproxen|Participants randomized to sumatriptan/naproxen upon presentation of migraine acute attack
342581|NCT01137773|E2|Reported Event|Convention Insulin Treatment|target glucose levels of 150-170 mg/dl
342282|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
342283|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
342284|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
342285|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
342286|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
342287|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
342288|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
342289|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
342290|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
342291|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
342292|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
342293|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
342294|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
342295|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
342296|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
342297|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
342298|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
342299|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
342300|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
342301|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
342302|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
342303|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
342304|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
342305|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
342306|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
342307|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
342308|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
342309|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
342310|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
342311|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
342312|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
342753|NCT01137435|E1|Reported Event|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
342313|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
342314|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
342315|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
342316|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
342317|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
342318|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
342319|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
342320|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
342321|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
342322|NCT01138150|O6|Outcome|Treatment Non-Responders|Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
342323|NCT01138150|O5|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
342324|NCT01138150|O4|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
342325|NCT01138150|O3|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
342326|NCT01138150|O2|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after after treatment with Treximet or sugar pill.
342327|NCT01138150|O1|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after treatment with Treximet or sugar pill.
342328|NCT01138150|E2|Reported Event|Sugar Pill|Placebo: One tablet of a sugar pill will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.
342329|NCT01138150|E1|Reported Event|Treximet|sumatriptan/naproxen sodium: One tablet of sumatriptan 85 mg and naproxen sodium 500 mg will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.
342330|NCT01138124|B5|Baseline|Total|Total of all reporting groups
342331|NCT01138124|B4|Baseline|Renal Cancer Controls|Renal cancer cases were risk set matched with up to 10 controls for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
342332|NCT01138124|B3|Baseline|Renal Cancer Cases|Incident renal cancer, defined as first time renal cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident renal cancer diagnosis. Renal cell carcinoma and renal pelvis cancer were included; Wilm’s tumor and cancer metastatic to kidney were excluded.
342333|NCT01138124|B2|Baseline|Pancreatic Cancer Controls|Pancreatic cancer cases were risk set matched with up to 10 controls for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
342334|NCT01138124|B1|Baseline|Pancreatic Cancer Cases|Incident pancreatic cancer, defined as first time pancreatic cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident pancreatic cancer diagnosis. Exocrine pancreatic cancer, endocrine pancreatic cancer, and carcinoma in situ were included. Cancer metastatic to the pancreas was excluded.
342335|NCT01138124|P4|Participant Flow|Renal Cancer Controls|Renal cancer cases were risk set matched with up to 10 controls for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
342375|NCT01138111|O4|Outcome|Progressed to AD (12 Month)|Results from 12 month scan for participants with progression from MCI to AD within 2 years after baseline scan.
342376|NCT01138111|O3|Outcome|Not Progressed to AD (12 Month)|Results from 12 month scan for participants with no progression to AD within 2 years after baseline scan.
342754|NCT01137396|B3|Baseline|Total|Total of all reporting groups
342336|NCT01138124|P3|Participant Flow|Renal Cancer Cases|Incident renal cancer, defined as first time renal cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident renal cancer diagnosis. Renal cell carcinoma and renal pelvis cancer were included; Wilm’s tumor and cancer metastatic to kidney were excluded.
342337|NCT01138124|P2|Participant Flow|Pancreatic Cancer Controls|"Pancreatic cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site.~The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin."
342338|NCT01138124|P1|Participant Flow|Pancreatic Cancer Cases|Incident pancreatic cancer, defined as first time pancreatic cancer diagnosis (READ/ Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident pancreatic cancer diagnosis. Exocrine pancreatic cancer, endocrine pancreatic cancer, and carcinoma in situ were included. Cancer metastatic to the pancreas was excluded.
342339|NCT01138124|O2|Outcome|Controls|Controls
342340|NCT01138124|O1|Outcome|Cases|Cases
342341|NCT01138124|O2|Outcome|Controls|Controls
342342|NCT01138124|O1|Outcome|Cases|Cases
342343|NCT01138124|O2|Outcome|Controls|Controls
342344|NCT01138124|O1|Outcome|Cases|Cases
342345|NCT01138124|O2|Outcome|Controls|Controls
342346|NCT01138124|O1|Outcome|Cases|Cases
342347|NCT01138124|O2|Outcome|Controls|Controls
342348|NCT01138124|O1|Outcome|Cases|Cases
342349|NCT01138124|O2|Outcome|Controls|Controls
342350|NCT01138124|O1|Outcome|Cases|Cases
342351|NCT01138124|O2|Outcome|Controls|Controls
342352|NCT01138124|O1|Outcome|Cases|Cases
342353|NCT01138124|O2|Outcome|Controls|Controls
342354|NCT01138124|O1|Outcome|Cases|Cases
342355|NCT01138124|E4|Reported Event|Renal Cancer Controls|Renal cancer cases were risk set matched with up to 10 controls for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
342356|NCT01138124|E3|Reported Event|Renal Cancer Cases|Incident renal cancer, defined as first time renal cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident renal cancer diagnosis. Renal cell carcinoma and renal pelvis cancer were included; Wilm’s tumor and cancer metastatic to kidney were excluded.
342357|NCT01138124|E2|Reported Event|Pancreatic Cancer Controls|Pancreatic cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
342358|NCT01138124|E1|Reported Event|Pancreatic Cancer Cases|Incident pancreatic cancer, defined as first time pancreatic cancer diagnosis (READ/ Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident pancreatic cancer diagnosis. Exocrine pancreatic cancer, endocrine pancreatic cancer, and carcinoma in situ were included. Cancer metastatic to the pancreas was excluded.
342359|NCT01138111|B1|Baseline|MCI Subjects|Subjects with mild cognitive impairment (MCI) receiving florbetaben (BAY94-9172) : single intravenous injection 2 mL to 10 mL, at baseline, at 12 and 24 months
342360|NCT01138111|P1|Participant Flow|MCI Subjects|Subjects with mild cognitive impairment (MCI) receiving florbetaben (BAY94-9172) : single intravenous injection of 300 megaBecqerels (MBq) florbetaben, at baseline, at 12 and 24 months
342361|NCT01138111|O6|Outcome|24 Month 90 Min|24 month PET scan at 90 min post-injection
342362|NCT01138111|O5|Outcome|24 Month 45 Min|24 month PET scan at 45 min post-injection
342363|NCT01138111|O4|Outcome|12 Month 90 Min|12 month PET scan at 90 min post-injection
342364|NCT01138111|O3|Outcome|12 Month 45 Min|12 month PET scan at 45 min post-injection
342365|NCT01138111|O2|Outcome|Baseline 90 Min|Baseline PET scan at 90 min post-injection
342366|NCT01138111|O1|Outcome|Baseline 45 Min|Baseline PET scan at 45 min post-injection
342367|NCT01138111|O6|Outcome|Progressed to AD (24 Month)|24 month PET scan results for subjects who progressed to AD within the two year follow up period
342368|NCT01138111|O5|Outcome|Not Progressed to AD (24 Month)|24 month scan results for subjects who did not progress to AD through the end of the two year follow up period
342369|NCT01138111|O4|Outcome|Progressed to AD (12 Month)|12 month PET scan results for subjects who progressed to AD within the two year follow up period
342370|NCT01138111|O3|Outcome|Not Progressed to AD (12 Month)|12 month PET scan results for subjects who did not progress to AD through the end of the two year follow up period
342371|NCT01138111|O2|Outcome|Progressed to AD (Baseline)|Baseline PET scan results for subjects who progressed to AD within the two year follow up period
342372|NCT01138111|O1|Outcome|Not Progressed to AD (Baseline)|Baseline PET scan results for subjects who did not progress to AD through the end of the two year follow up period
342373|NCT01138111|O6|Outcome|Progressed to AD (24 Month)|Results from 24 month scan for participants with progression from MCI to AD within 2 years after baseline scan.
342374|NCT01138111|O5|Outcome|Not Progressed to AD (24 Month)|Results from 24 month scan for participants with no progression to AD within 2 years after baseline scan.
342377|NCT01138111|O2|Outcome|Progressed to AD (Baseline)|Results from baseline scan for participants with progression from MCI to AD within 2 years after baseline scan.
342378|NCT01138111|O1|Outcome|Not Progressed to AD (Baseline)|Results from baseline scan for participants with no progression to AD within 2 years after baseline scan
342379|NCT01138111|O6|Outcome|Progressed to AD (24 Month)|Mean SUVR for the 24 month PET scan in subjects who progressed to AD during the study
342380|NCT01138111|O5|Outcome|Not Progressed to AD (24 Month)|Mean SUVR for the 24 month PET scan in subjects who did not progress to AD during the study
342381|NCT01138111|O4|Outcome|Progressed to AD (12 Month)|Mean SUVR for the 12 month PET scan in subjects who progressed to AD during the study
342382|NCT01138111|O3|Outcome|Not Progressed to AD (12 Month)|Mean SUVR for the 12 month PET scan in subjects who did not progress to AD during the study
342383|NCT01138111|O2|Outcome|Progressed to AD (Baseline)|Mean SUVR for the baseline PET scan in subjects who progressed to AD during the study
342384|NCT01138111|O1|Outcome|Not Progressed to AD (Baseline)|Mean SUVR for the baseline PET scan in subjects who did not progress to AD during the study
342385|NCT01138111|E3|Reported Event|MCI Subjects (2nd Repeat Drug Administration)|Subjects with AEs following the third administration of florbetaben (BAY94-9172) at the 24 month visit
342386|NCT01138111|E2|Reported Event|MCI Subjects (1st Repeat Drug Administration)|Subjects with AEs following the second administration of florbetaben (BAY94-9172) at the 12 month visit
342387|NCT01138111|E1|Reported Event|MCI Subjects (Initial Drug Administration)|Subjects with AEs following the initial administration of florbetaben (BAY94-9172) at the baseline visit
342388|NCT01138098|B3|Baseline|Total|Total of all reporting groups
342389|NCT01138098|B2|Baseline|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
342390|NCT01138098|B1|Baseline|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
342391|NCT01138098|P2|Participant Flow|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
342392|NCT01138098|P1|Participant Flow|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
342393|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
342394|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
342395|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
342396|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
342397|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
342398|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
342399|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
342400|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
342401|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
342402|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
342403|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
342466|NCT01138007|E1|Reported Event|Placebo|A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
342467|NCT01137890|B3|Baseline|Total|Total of all reporting groups
342404|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
342405|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
342406|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
342407|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
342408|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
342409|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
342410|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
342411|NCT01138098|E2|Reported Event|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
342412|NCT01138098|E1|Reported Event|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
342413|NCT01138046|B1|Baseline|Lapatinib 1500mg + Paclitaxel 80mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
342414|NCT01138046|P1|Participant Flow|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 milligrams (mg) once daily (QD) in combination with intravenous (IV) paclitaxel (80 milligrams per meters squared [mg/m^2]) weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
342415|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
342416|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
342417|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
342418|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
342419|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
342420|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
342421|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
342422|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
342423|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
342424|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
342425|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
342426|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
342427|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
342428|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
342429|NCT01138046|E1|Reported Event|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
342430|NCT01138007|B4|Baseline|Total|Total of all reporting groups
342431|NCT01138007|B3|Baseline|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
342432|NCT01138007|B2|Baseline|323U66 SR 150 mg|A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
342433|NCT01138007|B1|Baseline|Placebo|A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
342434|NCT01138007|P3|Participant Flow|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
342435|NCT01138007|P2|Participant Flow|323U66 SR 150 mg|A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
342436|NCT01138007|P1|Participant Flow|Placebo|A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
342437|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
342438|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
342439|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
342440|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
342441|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
342442|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
342443|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
342444|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
342445|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
342468|NCT01137890|B2|Baseline|Placebo|
342469|NCT01137890|B1|Baseline|Zonisamide|
342582|NCT01137773|E1|Reported Event|Intensive IV Insulin|Patients will receive IV insulin to maintain target glucose levels of 80-110 mg/dl
342583|NCT01137682|B4|Baseline|Total|Total of all reporting groups
343031|NCT01136408|O3|Outcome|Warfarin|"Dose-adjusted warfarin based on target INR values~Warfarin: Dose-adjusted warfarin based on target INR values"
342446|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
342447|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
342448|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
342449|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
342450|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
342451|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
342452|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
342453|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
342454|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
342455|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
342456|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
342457|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
342458|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
342459|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
342460|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
342461|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
342462|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
342463|NCT01138007|O1|Outcome|Placebo|A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
342464|NCT01138007|E3|Reported Event|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
342465|NCT01138007|E2|Reported Event|323U66 SR 150 mg|A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
342470|NCT01137890|P2|Participant Flow|Placebo|"Participants administered only placebo capsules containing lactose.~Placebo: capsules administered in split doses at 22:00 and 09:00.~Cocaine Hydrochloride: Cocaine Challenge Sessions: Human laboratory sessions with administration of moderate doses of cocaine by the intravenous route under controlled conditions and cardiovascular monitoring.~Neurocognitive and Performance Battery: Participants will complete tests to assess their abilities and performances on a number of tasks given by a computer or other type of equipment.~Smoking Assessments: Participants answer questions about smoking and smoking behaviors are monitored."
342471|NCT01137890|P1|Participant Flow|Zonisamide|"Participants administered blind capsules containing either placebo or zonisamide.~Zonisamide: Eight capsules administered daily in split doses at 22:00 and 09:00.~Cocaine Hydrochloride: Cocaine Challenge Sessions: Human laboratory sessions with administration of moderate doses of cocaine by the intravenous route under controlled conditions and cardiovascular monitoring.~Neurocognitive and Performance Battery: Participants will complete tests to assess their abilities and performances on a number of tasks given by a computer or other type of equipment.~Smoking Assessments: Participants answer questions about smoking and smoking behaviors are monitored."
342472|NCT01137890|O9|Outcome|40mg-600mg|40mg cocaine - 600mg zonisamide
342473|NCT01137890|O8|Outcome|40mg-300mg|40mg cocaine - 300mg zonisamide
342474|NCT01137890|O7|Outcome|40mg-0mg|40mg cocaine - 0mg zonisamide
342475|NCT01137890|O6|Outcome|20mg-600mg|20mg cocaine - 600mg zonisamide
342476|NCT01137890|O5|Outcome|20mg-300mg|20mg cocaine - 300mg zonisamide
342477|NCT01137890|O4|Outcome|20mg-0mg|20mg cocaine - 0mg zonisamide
342478|NCT01137890|O3|Outcome|1mg-600mg|1mg cocaine - 600mg zonisamide
342479|NCT01137890|O2|Outcome|1mg-300mg|1mg cocaine - 300mg zonisamide
342480|NCT01137890|O1|Outcome|1mg-0mg|"1mg cocaine - 0mg zonisamide~Both doses are expected to be inactive, thus this arm is viewed as Placebo"
342481|NCT01137890|O39|Outcome|Day 39|
342482|NCT01137890|O38|Outcome|Day 38|
342483|NCT01137890|O37|Outcome|Day 37|
342484|NCT01137890|O36|Outcome|Day 36|
342485|NCT01137890|O35|Outcome|Day 35|
342486|NCT01137890|O34|Outcome|Day 34|
342487|NCT01137890|O33|Outcome|Day 33|
342488|NCT01137890|O32|Outcome|Day 32|
342489|NCT01137890|O31|Outcome|Day 31|
342490|NCT01137890|O30|Outcome|Day 30|
342491|NCT01137890|O29|Outcome|Day 29|
342492|NCT01137890|O28|Outcome|Day 28|
342493|NCT01137890|O27|Outcome|Day 27|
342494|NCT01137890|O26|Outcome|Day 26|
342495|NCT01137890|O25|Outcome|Day 25|
342496|NCT01137890|O24|Outcome|Day 24|
342497|NCT01137890|O23|Outcome|Day 23|
342498|NCT01137890|O22|Outcome|Day 22|
342499|NCT01137890|O21|Outcome|Day 21|
342500|NCT01137890|O20|Outcome|Day 20|
342501|NCT01137890|O19|Outcome|Day 19|
342502|NCT01137890|O18|Outcome|Day 18|
342503|NCT01137890|O17|Outcome|Day 17|
342504|NCT01137890|O16|Outcome|Day 16|
342505|NCT01137890|O15|Outcome|Day 15|
342506|NCT01137890|O14|Outcome|Day 14|
342507|NCT01137890|O13|Outcome|Day 13|
342508|NCT01137890|O12|Outcome|Day 12|
342509|NCT01137890|O11|Outcome|Day 11|
342510|NCT01137890|O10|Outcome|Day 10|
342511|NCT01137890|O9|Outcome|Day 9|
342512|NCT01137890|O8|Outcome|Day 8|
342513|NCT01137890|O7|Outcome|Day 7|
342514|NCT01137890|O6|Outcome|Day 6|
342515|NCT01137890|O5|Outcome|Day 5|
342516|NCT01137890|O4|Outcome|Day 4|
342517|NCT01137890|O3|Outcome|Day 3|
342518|NCT01137890|O2|Outcome|Day 2|
342519|NCT01137890|O1|Outcome|Day 1|
342520|NCT01137890|O9|Outcome|40mg-600mg|40mg cocaine - 600mg zonisamide
342521|NCT01137890|O8|Outcome|40mg-300mg|40mg cocaine - 300mg zonisamide
342522|NCT01137890|O7|Outcome|40mg-0mg|40mg cocaine - 0mg zonisamide
342523|NCT01137890|O6|Outcome|20mg-600mg|20mg cocaine - 600mg zonisamide
342524|NCT01137890|O5|Outcome|20mg-300mg|20mg cocaine - 300mg zonisamide
342525|NCT01137890|O4|Outcome|20mg-0mg|20mg cocaine - 0mg zonisamide
342526|NCT01137890|O3|Outcome|1mg-600mg|1mg cocaine - 600mg zonisamide
342527|NCT01137890|O2|Outcome|1mg-300mg|1mg cocaine - 300mg zonisamide
342528|NCT01137890|O1|Outcome|1mg-0mg|"1mg cocaine - 0mg zonisamide~Both doses are expected to be inactive, thus this arm is viewed as Placebo"
342529|NCT01137890|O9|Outcome|40mg-600mg|40mg cocaine - 600mg zonisamide
342530|NCT01137890|O8|Outcome|40mg-300mg|40mg cocaine - 300mg zonisamide
342531|NCT01137890|O7|Outcome|40mg-0mg|40mg cocaine - 0mg zonisamide
342532|NCT01137890|O6|Outcome|20mg-600mg|20mg cocaine - 600mg zonisamide
342533|NCT01137890|O5|Outcome|20mg-300mg|20mg cocaine - 300mg zonisamide
342534|NCT01137890|O4|Outcome|20mg-0mg|20mg cocaine - 0mg zonisamide
342535|NCT01137890|O3|Outcome|1mg-600mg|1mg cocaine - 600mg zonisamide
342536|NCT01137890|O2|Outcome|1mg-300mg|1mg cocaine - 300mg zonisamide
342537|NCT01137890|O1|Outcome|1mg-0mg|"1mg cocaine - 0mg zonisamide~Both doses are expected to be inactive, thus this arm is viewed as Placebo"
342538|NCT01137890|E2|Reported Event|Placebo|"Participants administered only placebo capsules containing lactose.~Placebo: capsules administered in split doses at 22:00 and 09:00.~Cocaine Hydrochloride: Cocaine Challenge Sessions: Human laboratory sessions with administration of moderate doses of cocaine by the intravenous route under controlled conditions and cardiovascular monitoring.~Neurocognitive and Performance Battery: Participants will complete tests to assess their abilities and performances on a number of tasks given by a computer or other type of equipment.~Smoking Assessments: Participants answer questions about smoking and smoking behaviors are monitored."
342578|NCT01137773|O1|Outcome|Intensive IV Insulin|"Patients will receive IV insulin to maintain target glucose levels of 80-110 mg/dl~Insulin: All patients in the trial will have blood taken hourly for glucose analysis, regardless of their designated group. Adjustments of the insulin dose will be based on measurements of capillary blood glucose level."
342539|NCT01137890|E1|Reported Event|Zonisamide|"Participants administered blind capsules containing either placebo or zonisamide.~Zonisamide: Eight capsules administered daily in split doses at 22:00 and 09:00.~Cocaine Hydrochloride: Cocaine Challenge Sessions: Human laboratory sessions with administration of moderate doses of cocaine by the intravenous route under controlled conditions and cardiovascular monitoring.~Neurocognitive and Performance Battery: Participants will complete tests to assess their abilities and performances on a number of tasks given by a computer or other type of equipment.~Smoking Assessments: Participants answer questions about smoking and smoking behaviors are monitored."
342540|NCT01137812|B3|Baseline|Total|Total of all reporting groups
342541|NCT01137812|B2|Baseline|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
342542|NCT01137812|B1|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
342543|NCT01137812|P2|Participant Flow|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
342544|NCT01137812|P1|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
342545|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
342546|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
342547|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
342548|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
342549|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
342550|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
342551|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
342552|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
342553|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
342554|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
342555|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
342556|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
342557|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
342558|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
342559|NCT01137812|E2|Reported Event|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
342560|NCT01137812|E1|Reported Event|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
342561|NCT01137786|B3|Baseline|Total|Total of all reporting groups
342562|NCT01137786|B2|Baseline|Iopamidol 370 NGAL Evaluable Population|Non-ionic contrast media comparator: one time administration for PCI
342563|NCT01137786|B1|Baseline|Iodixanol 320 NGAL Evaluable Population|Non-ionic contrast media comparator: one time administration for PCI
342564|NCT01137786|P2|Participant Flow|Iopamidol 370|Non ionic contrast media comparator : one time administration for PCI
342565|NCT01137786|P1|Participant Flow|Iodixanol 320|Non ionic contrast media comparator : one time administration for PCI
342566|NCT01137786|O4|Outcome|Iopamidol 370 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24, and 48 hours post-administration of iopamidol 370.
342567|NCT01137786|O3|Outcome|Iopamidol 370 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iopamidol 370.
342568|NCT01137786|O2|Outcome|Iodixanol 320 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24, and 48 hours post-administration of iodixanol 320.
342569|NCT01137786|O1|Outcome|Iodixanol 320 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iodixanol 320.
342570|NCT01137786|E2|Reported Event|Iopamidol 370|Non ionic contrast media comparator : One time administration for PCI
342571|NCT01137786|E1|Reported Event|Iodixanol 320|Non ionic contrast media comparator : one time administration for PCI
342572|NCT01137773|B3|Baseline|Total|Total of all reporting groups
342573|NCT01137773|B2|Baseline|Convention Insulin Treatment|conventional (150–170 mg/dl, n = 20) glucose control
342574|NCT01137773|B1|Baseline|Intensive IV Insulin|Patients will received IV insulin to maintain target glucose levels of 80-110 mg/dl
342575|NCT01137773|P2|Participant Flow|Conventional Insulin Treatment|Subjects received conventional (150–170 mg/dl) glucose control
342576|NCT01137773|P1|Participant Flow|Intensive IV Insulin|Patients received target glucose levels of 80-110 mg/dl
342577|NCT01137773|O2|Outcome|Conventional Insulin Treatment|"Patents will receive conventional IV insulin treatment with target glucose levels of 150-170 mg/dl~Conventional insulin treatment: All patients in the trial will have blood taken hourly for glucose analysis , regardless of their designated group. Adjustments of the insulin dose will be based on measurements of capillary blood glucose level."
342584|NCT01137682|B3|Baseline|Control Arm (Octreotide or Lanreotide)|Open label octreotide LAR 30 mg or lanreotide ATG 120 mg supplied either locally or from designated depot. Administered intramuscular every 28 days
342585|NCT01137682|B2|Baseline|Pasireotide LAR 60 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
342586|NCT01137682|B1|Baseline|Pasireotide LAR 40 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
342587|NCT01137682|P3|Participant Flow|Control Arm (Octreotide or Lanreotide)|Open label octreotide LAR 30 mg or lanreotide ATG 120 mg supplied either locally or from designated depot. Administered intramuscular every 28 days
342588|NCT01137682|P2|Participant Flow|Pasireotide LAR 60 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
342589|NCT01137682|P1|Participant Flow|Pasireotide LAR 40 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
342590|NCT01137682|O2|Outcome|Pasireotide LAR 60 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
342591|NCT01137682|O1|Outcome|Pasireotide LAR 40 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
342592|NCT01137682|O3|Outcome|Cross Over to Pasireotide Extension|Open - label 60 mg pasireotide. Control group from CORE discontinued study if controlled in CORE. If uncontrolled in CORE, switched to open label 60 mg pasireotide. Extension blinded 40 and 60 mg switched to open label if became uncontrolled.
342593|NCT01137682|O2|Outcome|Pasireotide LAR 60 mg Extension|If controlled on 60 mg in CORE, remain on blinded 60 mg in extension. If patient became uncontrolled, switch to open label 60 mg
342594|NCT01137682|O1|Outcome|Pasireotide LAR 40 mg Extension|If controlled on 40 mg in CORE, remain on blinded 40 mg in extension. If patient became uncontrolled, switch to open label 60 mg
342595|NCT01137682|O2|Outcome|Pasireotide LAR 60 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
342596|NCT01137682|O1|Outcome|Pasireotide LAR 40 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
342597|NCT01137682|O3|Outcome|Cross Over to Pasireotide Extension|Open - label 60 mg pasireotide. Control group from CORE discontinued study if controlled in CORE. If uncontrolled in CORE, switched to open label 60 mg pasireotide. Extension blinded 40 and 60 mg switched to open label if became uncontrolled.
342598|NCT01137682|O2|Outcome|Pasireotide LAR 60 mg Extension|If controlled on 60 mg in CORE, remain on blinded 60 mg in extension. If patient became uncontrolled, switch to open label 60 mg
342599|NCT01137682|O1|Outcome|Pasireotide LAR 40 mg Extension|If controlled on 40 mg in CORE, remain on blinded 40 mg in extension. If patient became uncontrolled, switch to open label 60 mg
342600|NCT01137682|O3|Outcome|Cross Over to Pasireotide Extension|Open - label 60 mg pasireotide. Control group from CORE discontinued study if controlled in CORE. If uncontrolled in CORE, switched to open label 60 mg pasireotide. Extension blinded 40 and 60 mg switched to open label if became uncontrolled.
342601|NCT01137682|O2|Outcome|Pasireotide LAR 60 mg Extension|If controlled on 60 mg in CORE, remain on blinded 60 mg in extension. If patient became uncontrolled, switch to open label 60 mg
342602|NCT01137682|O1|Outcome|Pasireotide LAR 40 mg Extension|If controlled on 40 mg in CORE, remain on blinded 40 mg in extension. If patient became uncontrolled, switch to open label 60 mg
342603|NCT01137682|O3|Outcome|Cross Over to Pasireotide Extension|Open - label 60 mg pasireotide. Control group from CORE discontinued study if controlled in CORE. If uncontrolled in CORE, switched to open label 60 mg pasireotide. Extension blinded 40 and 60 mg switched to open label if became uncontrolled.
342604|NCT01137682|O2|Outcome|Pasireotide LAR 60 mg Extension|If controlled on 60 mg in CORE, remain on blinded 60 mg in extension. If patient became uncontrolled, switch to open label 60 mg
342605|NCT01137682|O1|Outcome|Pasireotide LAR 40 mg Extension|If controlled on 40 mg in CORE, remain on blinded 40 mg in extension. If patient became uncontrolled, switch to open label 60 mg
342606|NCT01137682|O2|Outcome|Pasireotide LAR 60 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
342607|NCT01137682|O1|Outcome|Pasireotide LAR 40 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
342608|NCT01137682|O3|Outcome|Cross Over to Pasireotide Extension|Open - label 60 mg pasireotide. Control group from CORE discontinued study if controlled in CORE. If uncontrolled in CORE, switched to open label 60 mg pasireotide. Extension blinded 40 and 60 mg switched to open label if became uncontrolled.
342609|NCT01137682|O2|Outcome|Pasireotide LAR 60 mg Extension|If controlled on 60 mg in CORE, remain on blinded 60 mg in extension. If patient became uncontrolled, switch to open label 60 mg
342610|NCT01137682|O1|Outcome|Pasireotide LAR 40 mg Extension|If controlled on 40 mg in CORE, remain on blinded 40 mg in extension. If patient became uncontrolled, switch to open label 60 mg
342611|NCT01137682|O2|Outcome|Pasireotide LAR 60 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
342612|NCT01137682|O1|Outcome|Pasireotide LAR 40 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
342613|NCT01137682|O3|Outcome|Cross Over to Pasireotide Extension|Open - label 60 mg pasireotide. Control group from CORE discontinued study if controlled in CORE. If uncontrolled in CORE, switched to open label 60 mg pasireotide. Extension blinded 40 and 60 mg switched to open label if became uncontrolled.
342614|NCT01137682|O2|Outcome|Pasireotide LAR 60 mg Extension|If controlled on 60 mg in CORE, remain on blinded 60 mg in extension. If patient became uncontrolled, switch to open label 60 mg
342615|NCT01137682|O1|Outcome|Pasireotide LAR 40 mg Extension|If controlled on 40 mg in CORE, remain on blinded 40 mg in extension. If patient became uncontrolled, switch to open label 60 mg
342722|NCT01137474|B5|Baseline|Total|Total of all reporting groups
342616|NCT01137682|O3|Outcome|Cross Over to Pasireotide Extension|Open - label 60 mg pasireotide. Control group from CORE discontinued study if controlled in CORE. If uncontrolled in CORE, switched to open label 60 mg pasireotide. Extension blinded 40 and 60 mg switched to open label if became uncontrolled.
342617|NCT01137682|O2|Outcome|Pasireotide LAR 60 mg Extension|If controlled on 60 mg in CORE, remain on blinded 60 mg in extension. If patient became uncontrolled, switch to open label 60 mg
342618|NCT01137682|O1|Outcome|Pasireotide LAR 40 mg Extension|If controlled on 40 mg in CORE, remain on blinded 40 mg in extension. If patient became uncontrolled, switch to open label 60 mg
342619|NCT01137682|O3|Outcome|Control Arm (Octreotide or Lanreotide) Extension|Open - label 60 mg pasireotide. Control group from CORE discontinued study if controlled in CORE. If uncontrolled in CORE, switched to open label 60 mg pasireotide. Extension blinded 40 and 60 mg switched to open label if became uncontrolled
342620|NCT01137682|O2|Outcome|Pasireotide LAR 60 mg Extension|If controlled on 60 mg in CORE, remain on blinded 60 mg in extension. If patient became uncontrolled, switch to open label 60 mg
342621|NCT01137682|O1|Outcome|Pasireotide LAR 40 mg Extension|If controlled on 40 mg in CORE, remain on blinded 40 mg in extension. If patient became uncontrolled, switch to open label 60 mg
342622|NCT01137682|O3|Outcome|Cross Over to Pasireotide Extension|Open - label 60 mg pasireotide. Control group from CORE discontinued study if controlled in CORE. If uncontrolled in CORE, switched to open label 60 mg pasireotide. Extension blinded 40 and 60 mg switched to open label if became uncontrolled.
342623|NCT01137682|O2|Outcome|Pasireotide LAR 60 mg Extension|If controlled on 60 mg in CORE, remain on blinded 60 mg in extension. If patient became uncontrolled, switch to open label 60 mg
342624|NCT01137682|O1|Outcome|Pasireotide LAR 40 mg Extension|If controlled on 40 mg in CORE, remain on blinded 40 mg in extension. If patient became uncontrolled, switch to open label 60 mg
342625|NCT01137682|O3|Outcome|Cross Over to Pasireotide Extension|Open - label 60 mg pasireotide. Control group from CORE discontinued study if controlled in CORE. If uncontrolled in CORE, switched to open label 60 mg pasireotide. Extension blinded 40 and 60 mg switched to open label if became uncontrolled.
342626|NCT01137682|O2|Outcome|Pasireotide LAR 60 mg Extension|If controlled on 60 mg in CORE, remain on blinded 60 mg in extension. If patient became uncontrolled, switch to open label 60 mg
342627|NCT01137682|O1|Outcome|Pasireotide LAR 40 mg Extension|If controlled on 40 mg in CORE, remain on blinded 40 mg in extension. If patient became uncontrolled, switch to open label 60 mg
342628|NCT01137682|O3|Outcome|Control Arm (Octreotide or Lanreotide)|Open label octreotide LAR 30 mg or lanreotide ATG 120 mg supplied either locally or from designated depot. Administered intramuscular every 28 days
342629|NCT01137682|O2|Outcome|Pasireotide LAR 60 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
342630|NCT01137682|O1|Outcome|Pasireotide LAR 40 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
342631|NCT01137682|E3|Reported Event|Cross-over to Pasireotide|Cross-over to pasireotide
342632|NCT01137682|E2|Reported Event|Pasireotide LAR 60 mg|Pasireotide LAR 60 mg
342633|NCT01137682|E1|Reported Event|Pasireotide LAR 40 mg|Pasireotide LAR 40 mg
342634|NCT01137604|B5|Baseline|Total|Total of all reporting groups
342635|NCT01137604|B4|Baseline|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342636|NCT01137604|B3|Baseline|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342637|NCT01137604|B2|Baseline|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342638|NCT01137604|B1|Baseline|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
342639|NCT01137604|P4|Participant Flow|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342640|NCT01137604|P3|Participant Flow|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342641|NCT01137604|P2|Participant Flow|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342642|NCT01137604|P1|Participant Flow|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
342643|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342644|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342645|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342646|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
342647|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342755|NCT01137396|B2|Baseline|Placebo|"Placebo: Placebo medication Qdaily for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
342648|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342649|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342650|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
342651|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342652|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342653|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342654|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
342655|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342656|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342657|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342658|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
342659|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342660|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342661|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342662|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
342663|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342664|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342665|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342666|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
342667|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342668|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342669|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342670|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
342671|NCT01137604|E4|Reported Event|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342672|NCT01137604|E3|Reported Event|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342673|NCT01137604|E2|Reported Event|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
342674|NCT01137604|E1|Reported Event|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
342675|NCT01137578|B1|Baseline|All Imaged Participants|Baseline parameters for all participants in Cohorts A, B, and C: Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
342676|NCT01137578|P3|Participant Flow|Sub-Study Cohort C|A Sub-study with additional cohort C was initiated to collect diagnostic imaging procedures for the detection of CVC-related DVT in a population < 18 years of age who had a CVC in place and who were scheduled to undergo a contrast enhanced MRI in any part of their body as part of their clinical care and who allowed the diagnostic imaging procedure to include the area around the CVC. Participants who developed symptoms of VTE prior to imaging should have been switched to Cohort B.
342677|NCT01137578|P2|Participant Flow|Cohort B|Cohort B included pediatric participants (full-term newborns to <18 years) with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT based on radiographic imaging performed for other clinical reasons. Diagnostic imaging procedures, US and MRI (with and without gadolinium contrast enhancement) were to be done within 48 hours of each other or, for those with therapeutic anticoagulation, within 24 hours. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT.
342678|NCT01137578|P1|Participant Flow|Cohort A|Cohort A included pediatric participants (full-term newborns to <18 years) in which a CVC was recently placed and who were asymptomatic for CVC-related deep vein thrombosis (DVT). Imaging procedures occurred on Day 40 ± 20 days relative to catheter placement (Day 0) and included: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used for MRI with contrast. No sedation or anesthesia was to be allowed. Participants who developed symptoms of VTE prior to imaging should have been switched to Cohort B.
342679|NCT01137578|O1|Outcome|All Imaged Participants|All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
342680|NCT01137578|O9|Outcome|Cohort C 12Years to <18Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
342681|NCT01137578|O8|Outcome|Cohort C 2Years to <12Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
342682|NCT01137578|O7|Outcome|Cohort C Newborn to <2Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
342683|NCT01137578|O6|Outcome|Cohort B 12Years to <18Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
342684|NCT01137578|O5|Outcome|Cohort B 2Years to <12Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
342685|NCT01137578|O4|Outcome|Cohort B Newborn to <2Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
342686|NCT01137578|O3|Outcome|Cohort A 12Years to <18Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
343085|NCT01136382|B2|Baseline|Budesonide|Budesonide pMDI 160 mcg bid
343086|NCT01136382|B1|Baseline|Placebo|Placebo pMDI bid
342687|NCT01137578|O2|Outcome|Cohort A 2Years to <12Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
342688|NCT01137578|O1|Outcome|Cohort A Newborn to <2Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
342689|NCT01137578|O3|Outcome|Cohort C|A Sub-study with additional cohort C was initiated to collect diagnostic imaging procedures for the detection of CVC-related DVT in a population < 18 years of age who had a CVC in place and who were scheduled to undergo a contrast enhanced MRI in any part of their body as part of their clinical care and who allowed the diagnostic imaging procedure to include the area around the CVC. Participants who developed symptoms of VTE prior to imaging should have been switched to Cohort B.
342690|NCT01137578|O2|Outcome|Cohort B|Pediatric Participants (full-term newborns to <18 years) with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
342691|NCT01137578|O1|Outcome|Cohort A|Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia to be allowed. Participants enrolled in Cohort A and who developed symptoms of a venous thromboembolism (VTE), including a symptomatic DVT or a symptomatic pulmonary embolism (PE) prior to their MRI/US, should have been switched to Cohort B.
342692|NCT01137578|O4|Outcome|All Imaged Participants: No MRI With Contrast Performed|Participant had at least one radiographic imaging procedure performed but no study-related MRI with contrast was performed. Pediatric participants in which a CVC was to be placed or who had a CVC in place were included. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
342693|NCT01137578|O3|Outcome|All Imaged Participants: No MRI Without Contrast Performed|Participant had at least one radiographic imaging procedure performed but no study-related MRI without contrast was performed. Pediatric participants in which a CVC was to be placed or who had a CVC in place were included. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
342694|NCT01137578|O2|Outcome|All Imaged Participants: Unilateral Ultrasound Performed|Participant had at least one radiographic imaging procedure performed but a study-related unilateral US instead of a bilateral US was completed. Bilateral US was the protocol-defined procedure but if the participant was not able to complete a bilateral US, then the unilateral US was accepted for evaluation. Pediatric participants in which a CVC was to be placed or who had a CVC in place were included. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
342695|NCT01137578|O1|Outcome|All Imaged Participants: No Ultrasound Performed|Participant had at least one radiographic imaging procedure performed but no study-related US (either bilateral or unilateral) was performed. Pediatric participants in which a CVC was to be placed or who had a CVC in place were included. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
342696|NCT01137578|O6|Outcome|Cohort C Participants 12Years to 18 Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
342697|NCT01137578|O5|Outcome|Cohort C Participants <12Years of Age|A Sub-study with additional cohort C was initiated to collect diagnostic imaging procedures for the detection of CVC related DVT in a population < 18 years of age who had a CVC in place and who were scheduled to undergo a contrast enhanced MRI in any part of their body as part of their clinical care and who allowed the diagnostic imaging procedure to include the area around the CVC.
342723|NCT01137474|B4|Baseline|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
343087|NCT01136382|P2|Participant Flow|Budesonide|Budesonide pMDI 160 mcg bid
342698|NCT01137578|O4|Outcome|Cohort B Participants 12Years to 18 Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
342699|NCT01137578|O3|Outcome|Cohort B Participants <12Years of Age|Cohort B included pediatric participants (full-term newborns to <18 years) with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons. Diagnostic imaging procedures, US and MRI (with and without contrast enhancement) were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
342700|NCT01137578|O2|Outcome|Cohort A Participants 12Years to 18 Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
342701|NCT01137578|O1|Outcome|Cohort A Participants <12Years of Age|Cohort A included pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT). Diagnostic imaging procedures included: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was allowed.
342702|NCT01137578|O3|Outcome|Cohort C|Participants with a CVC in place and having an MRI for clinical reasons were enrolled.
342703|NCT01137578|O2|Outcome|Cohort B|Pediatric Participants (full-term newborns to <18 years) with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
342704|NCT01137578|O1|Outcome|Cohort A|Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia to be allowed. Participants enrolled in Cohort A and who developed symptoms of a venous thromboembolism (VTE), including a symptomatic DVT or a symptomatic pulmonary embolism (PE) prior to their MRI/US, were switched to Cohort B.
342705|NCT01137578|O1|Outcome|All Imaged Participants|All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
342706|NCT01137578|O9|Outcome|Cohort C 12Years to <18Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
342707|NCT01137578|O8|Outcome|Cohort C 2Years to <12Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
342708|NCT01137578|O7|Outcome|Cohort C Newborn to <2Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
342724|NCT01137474|B3|Baseline|Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 5 mg, daily with a morning meal.
342725|NCT01137474|B2|Baseline|Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 2.5 mg, daily with a morning meal.
342709|NCT01137578|O6|Outcome|Cohort B 12Years to <18Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
342710|NCT01137578|O5|Outcome|Cohort B 2Years to <12Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
342711|NCT01137578|O4|Outcome|Cohort B Newborn to <2Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
342712|NCT01137578|O3|Outcome|Cohort A 12Years to <18Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
342713|NCT01137578|O2|Outcome|Cohort A 2Years to <12Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
342714|NCT01137578|O1|Outcome|Cohort A Newborn to <2Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
342715|NCT01137578|O1|Outcome|All Imaged Participants|All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
342716|NCT01137578|E1|Reported Event|All Imaged Participants|All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
342717|NCT01137539|B1|Baseline|Gynecare TVT-SECUR System|"All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence~Gynecare TVT-SECUR system: All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence"
342718|NCT01137539|P1|Participant Flow|Gynecare TVT-SECUR System|"All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence~Gynecare TVT-SECUR system: All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence"
342719|NCT01137539|O1|Outcome|Gynecare TVT-SECUR System|"All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence~Gynecare TVT-SECUR system: All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence"
342720|NCT01137539|O1|Outcome|Gynecare TVT-SECUR System|"All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence~Gynecare TVT-SECUR system: All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence"
342721|NCT01137539|E1|Reported Event|Gynecare TVT-SECUR System|"All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence~Gynecare TVT-SECUR system: All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence"
342726|NCT01137474|B1|Baseline|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
342727|NCT01137474|P4|Participant Flow|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
342728|NCT01137474|P3|Participant Flow|Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 5 mg, daily with a morning meal.
342729|NCT01137474|P2|Participant Flow|Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 2.5 mg, daily with a morning meal.
342730|NCT01137474|P1|Participant Flow|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
342731|NCT01137474|O2|Outcome|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
342732|NCT01137474|O1|Outcome|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
342733|NCT01137474|O2|Outcome|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
342734|NCT01137474|O1|Outcome|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
342735|NCT01137474|O2|Outcome|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
342736|NCT01137474|O1|Outcome|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
342737|NCT01137474|O2|Outcome|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
342738|NCT01137474|O1|Outcome|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
342739|NCT01137474|O2|Outcome|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
342740|NCT01137474|O1|Outcome|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
342741|NCT01137474|O2|Outcome|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
342742|NCT01137474|O1|Outcome|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
342743|NCT01137474|E4|Reported Event|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
342744|NCT01137474|E3|Reported Event|Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 5 mg, daily with a morning meal.
342745|NCT01137474|E2|Reported Event|Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 2.5 mg, daily with a morning meal.
342746|NCT01137474|E1|Reported Event|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
342747|NCT01137435|B1|Baseline|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
342748|NCT01137435|P1|Participant Flow|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
342749|NCT01137435|O1|Outcome|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
342750|NCT01137435|O1|Outcome|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
342751|NCT01137435|O1|Outcome|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
342752|NCT01137435|O1|Outcome|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
342756|NCT01137396|B1|Baseline|Modafinil|"Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
342757|NCT01137396|P2|Participant Flow|Placebo|"Placebo: Placebo medication Qdaily for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
342758|NCT01137396|P1|Participant Flow|Modafinil|"Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
342759|NCT01137396|O2|Outcome|Placebo|"Placebo: Placebo medication Qdaily for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
342760|NCT01137396|O1|Outcome|Modafinil|"Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
342761|NCT01137396|O2|Outcome|Placebo|"Placebo: Placebo medication Qdaily for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
342762|NCT01137396|O1|Outcome|Modafinil|"Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
342763|NCT01137396|E2|Reported Event|Placebo|"Placebo: Placebo medication Qdaily for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
342764|NCT01137396|E1|Reported Event|Modafinil|"Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
342765|NCT01137370|B3|Baseline|Total|Total of all reporting groups
342766|NCT01137370|B2|Baseline|People Without TB|
342767|NCT01137370|B1|Baseline|Patients With TB|
342768|NCT01137370|P2|Participant Flow|People Without TB|
342769|NCT01137370|P1|Participant Flow|Patients With TB|
342770|NCT01137370|O2|Outcome|People Without TB|
342771|NCT01137370|O1|Outcome|Patients With TB|
342772|NCT01137370|E2|Reported Event|People Without TB|
342773|NCT01137370|E1|Reported Event|Patients With TB|
342774|NCT01137292|B1|Baseline|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.~Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
342775|NCT01137292|P1|Participant Flow|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.~Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
342776|NCT01137292|O1|Outcome|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.~Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
342777|NCT01137292|O1|Outcome|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.~Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
342778|NCT01137292|O1|Outcome|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.~Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
342779|NCT01137292|O1|Outcome|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.~Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
342780|NCT01137292|E1|Reported Event|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.~Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
342781|NCT01137071|B1|Baseline|Monoclonal Antibody hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342782|NCT01137071|P1|Participant Flow|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342783|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342784|NCT01137071|O1|Outcome|Pharmacokinetic|All patients enrolled in the study that received at least 9 doses of investigational product were considered to this analysis.
342785|NCT01137071|O1|Outcome|Monoclonal Antibody hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342786|NCT01137071|O1|Outcome|Monoclonal Antibody hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342787|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342788|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342789|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342790|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342791|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342792|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342793|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342794|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342795|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342796|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342797|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342798|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342799|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342800|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342801|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342802|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342803|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342804|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342805|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342806|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342807|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342808|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342809|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342810|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342811|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342812|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342813|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342814|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342815|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342816|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342817|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342818|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342819|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342820|NCT01137071|O1|Outcome|hu3S193|"Monoclonal antibody hu3S193 was administered to 29 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks.~Anti-Lewis Y humanized monoclonal antibody designated orphan drug by the FDA on March 09, 2012 for the treatment of ovarian cancer, not yet approved for the orphan designation."
342821|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342822|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342823|NCT01137071|O1|Outcome|hu3S193|"Monoclonal antibody hu3S193 was administered to 29 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks.~Anti-Lewis Y humanized monoclonal antibody designated orphan drug by the FDA on March 09, 2012 for the treatment of ovarian cancer, not yet approved for the orphan designation."
342824|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342825|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342826|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342827|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342828|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342829|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks.
342830|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342831|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342832|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342833|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342834|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342835|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342836|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342837|NCT01137071|O1|Outcome|hu3S193|hu3S193 was administered to 29 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks.
342838|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342839|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342840|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342841|NCT01137071|E1|Reported Event|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
342842|NCT01137032|B1|Baseline|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
342843|NCT01137032|P1|Participant Flow|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
342844|NCT01137032|O1|Outcome|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
342845|NCT01137032|O1|Outcome|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
342846|NCT01137032|O1|Outcome|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
342847|NCT01137032|E1|Reported Event|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
342848|NCT01136967|B3|Baseline|Total|Total of all reporting groups
342849|NCT01136967|B2|Baseline|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
342850|NCT01136967|B1|Baseline|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
342851|NCT01136967|P2|Participant Flow|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
342852|NCT01136967|P1|Participant Flow|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
342853|NCT01136967|O2|Outcome|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
342854|NCT01136967|O1|Outcome|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
342855|NCT01136967|O2|Outcome|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
342856|NCT01136967|O1|Outcome|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
343088|NCT01136382|P1|Participant Flow|Placebo|Placebo pMDI bid
342857|NCT01136967|O2|Outcome|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
342858|NCT01136967|O1|Outcome|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
342859|NCT01136967|O2|Outcome|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
342860|NCT01136967|O1|Outcome|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
342861|NCT01136967|O2|Outcome|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
342862|NCT01136967|O1|Outcome|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
342863|NCT01136967|O2|Outcome|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
342864|NCT01136967|O1|Outcome|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
342865|NCT01136967|E2|Reported Event|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
342866|NCT01136967|E1|Reported Event|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
342867|NCT01136954|B3|Baseline|Total|Total of all reporting groups
342868|NCT01136954|B2|Baseline|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
342869|NCT01136954|B1|Baseline|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
342870|NCT01136954|P2|Participant Flow|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
342871|NCT01136954|P1|Participant Flow|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
342872|NCT01136954|O2|Outcome|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
342873|NCT01136954|O1|Outcome|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
342874|NCT01136954|O2|Outcome|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
342903|NCT01136876|E1|Reported Event|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
342904|NCT01136785|B3|Baseline|Total|Total of all reporting groups
342875|NCT01136954|O1|Outcome|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
342876|NCT01136954|O2|Outcome|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
342877|NCT01136954|O1|Outcome|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
342878|NCT01136954|O2|Outcome|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
342879|NCT01136954|O1|Outcome|Zonisamide (Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
342880|NCT01136954|E2|Reported Event|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
342881|NCT01136954|E1|Reported Event|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
342882|NCT01136915|B3|Baseline|Total|Total of all reporting groups
342883|NCT01136915|B2|Baseline|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single intravenous administration for percutaneous coronary intervention procedure; dose was limited to the minimum volume required to achieve diagnostic information and/or guide therapeutic intervention.
342884|NCT01136915|B1|Baseline|Iopamidol 370|Iopamidol 370: Non-ionic low-osmolar iodinated contrast media: single intravenous administration for percutaneous coronary intervention procedure; dose was limited to the minimum volume required to achieve diagnostic information and/or guide therapeutic intervention.
342885|NCT01136915|P2|Participant Flow|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
342886|NCT01136915|P1|Participant Flow|Iopamidol 370|Iopamidol 370: Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure
342887|NCT01136915|O4|Outcome|Iodixanol 320 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24,and 48 hours post-administration of iodixanol 320
342888|NCT01136915|O3|Outcome|Iodixanol 320 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iodixanol 320
342889|NCT01136915|O2|Outcome|Iopamidol 370 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24,and 48 hours post-administration of iopamidol 370
342890|NCT01136915|O1|Outcome|Iopamidol 370 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iopamidol 370
342891|NCT01136915|E2|Reported Event|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
342892|NCT01136915|E1|Reported Event|Iopamidol 370|Iopamidol 370: Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure
342893|NCT01136876|B3|Baseline|Total|Total of all reporting groups
342894|NCT01136876|B2|Baseline|Iopamidol 370|Iopamidol 370 Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure
342895|NCT01136876|B1|Baseline|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
342896|NCT01136876|P2|Participant Flow|Iopamidol 370|Iopamidol 370 Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure
342897|NCT01136876|P1|Participant Flow|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
342898|NCT01136876|O4|Outcome|Iopamidol 370 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24,and 48 hours post-administration of iopamidol 370
342899|NCT01136876|O3|Outcome|Iopamidol 370 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iopamidol 370
342900|NCT01136876|O2|Outcome|Iodixanol 320 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24, and 48 hours post-administration of iodixanol 320
342901|NCT01136876|O1|Outcome|Iodixanol 320 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iodixanol 320
342902|NCT01136876|E2|Reported Event|Iopamidol 370|Iopamidol 370 Non-ionic low osmolar iodinated contrast media: single administration for percutaneous coronary intervention
342906|NCT01136785|B1|Baseline|Active CPAP|"7 days of treatment in the laboratory with active CPAP.~Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea"
342907|NCT01136785|P2|Participant Flow|Sham CPAP|7 days of sham CPAP in the laboratory.
342908|NCT01136785|P1|Participant Flow|Active CPAP|"7 days of treatment in the laboratory with active CPAP.~Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea"
342909|NCT01136785|O1|Outcome|Active CPAP|The goal of the present analysis is to explore mechanisms by which CPAP therapy led to improvement in the 24-h glucose levels. We focus on the 8 participants who had complete 24-h profiles of plasma norepinephrine before and after treatment with active CPAP.
342910|NCT01136785|O1|Outcome|Active CPAP|The goal of the present analysis is to explore mechanisms by which CPAP therapy led to improvement in the 24-h glucose levels. We focus on the 12 participants who had complete 24-h profiles of glucose, insulin and counter-regulatory hormones before and after treatment with active CPAP.
342911|NCT01136785|O1|Outcome|Active CPAP|The goal of the present analysis is to explore mechanisms by which CPAP therapy led to improvement in the 24-h glucose levels. We focus on the 12 participants who had complete 24-h profiles of glucose, insulin and counter-regulatory hormones before and after treatment with active CPAP.
342912|NCT01136785|O2|Outcome|CPAP|7 days of sham CPAP in the laboratory.
342913|NCT01136785|O1|Outcome|Active CPAP|"7 days of treatment in the laboratory with active CPAP.~Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea"
342914|NCT01136785|O2|Outcome|Sham CPAP|7 days of sham CPAP in the laboratory.
342915|NCT01136785|O1|Outcome|Active CPAP|"7 days of treatment in the laboratory with active CPAP.~Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea"
342916|NCT01136785|O2|Outcome|Sham CPAP|7 days of sham CPAP in the laboratory.
342917|NCT01136785|O1|Outcome|Active CPAP|7 days of treatment in the laboratory with active CPAP. Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea
342918|NCT01136785|E2|Reported Event|Sham CPAP|7 days of sham CPAP in the laboratory.
342919|NCT01136785|E1|Reported Event|Active CPAP|"7 days of treatment in the laboratory with active CPAP.~Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea"
342920|NCT01136772|B3|Baseline|Total|Total of all reporting groups
342921|NCT01136772|B2|Baseline|Haloperidol Decanoate|Intramuscular injections of haloperidol decanoate 25-200 mg every month
342922|NCT01136772|B1|Baseline|Paliperidone Palmitate|Intramuscular injections of paliperidone palmitate 39-234 mg every month
342923|NCT01136772|P2|Participant Flow|Haloperidol Decanoate|Intramuscular injections of haloperidol decanoate 25-200 mg every month
342924|NCT01136772|P1|Participant Flow|Paliperidone Palmitate|Intramuscular injections of paliperidone palmitate 39-234 mg every month
342925|NCT01136772|O2|Outcome|Haloperidol Decanoate|Intramuscular injections of haloperidol decanoate 25-200 mg every month
342926|NCT01136772|O1|Outcome|Paliperidone Palmitate|Intramuscular injections of paliperidone palmitate 39-234 mg every month
342927|NCT01136772|O2|Outcome|Haloperidol Decanoate|Intramuscular injections of haloperidol decanoate 25-200 mg every month
342928|NCT01136772|O1|Outcome|Paliperidone Palmitate|Intramuscular injections of paliperidone palmitate 39-234 mg every month
342929|NCT01136772|E2|Reported Event|Haloperidol Decanoate|Intramuscular injections of haloperidol decanoate 25-200 mg every month
342930|NCT01136772|E1|Reported Event|Paliperidone Palmitate|Intramuscular injections of paliperidone palmitate 39-234 mg every month
342931|NCT01136746|B3|Baseline|Total|Total of all reporting groups
342932|NCT01136746|B2|Baseline|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342933|NCT01136746|B1|Baseline|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342934|NCT01136746|P2|Participant Flow|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342935|NCT01136746|P1|Participant Flow|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342936|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342937|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342938|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342939|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342940|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342941|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342942|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342943|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342944|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342945|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342946|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342947|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342948|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342949|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342950|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342951|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342952|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342953|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342954|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342955|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342956|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342957|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342958|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342959|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342960|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342961|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342962|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342963|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342987|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342964|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342965|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342966|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342967|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342968|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342969|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342970|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342971|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342972|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342973|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342974|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342975|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342976|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342977|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342978|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342979|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342980|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342981|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342982|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342983|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342984|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342985|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342986|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
343089|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
343090|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
342988|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342989|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342990|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342991|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342992|NCT01136746|E2|Reported Event|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
342993|NCT01136746|E1|Reported Event|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
342994|NCT01136655|B1|Baseline|Randomized Patients|All randomized patients
342995|NCT01136655|P1|Participant Flow|Randomized Patients|All randomized patients
342996|NCT01136655|O4|Outcome|BUD 160/ Foradil 12.0|Foradil Aerolizer 12 μg x 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
342997|NCT01136655|O3|Outcome|BUD 160/FM 9.0|placebo HFA pMDI x 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI x 2 inhalations)
342998|NCT01136655|O2|Outcome|BUD 160/FM 4.5|placebo HFA pMDI x 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI x 2 inhalations)
342999|NCT01136655|O1|Outcome|BUD 160/FM 2.25|2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI x 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations
343000|NCT01136655|O5|Outcome|BUD 160/ Foradil 12.0|Foradil Aerolizer 12 μg x 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
343001|NCT01136655|O4|Outcome|BUD 160|placebo HFA pMDI x 1 inhalation + 80 μg budesonide HFA pMDI x 2 inhalations
343002|NCT01136655|O3|Outcome|BUD 160/FM 9.0|placebo HFA pMDI x 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI x 2 inhalations)
343003|NCT01136655|O2|Outcome|BUD 160/FM 4.5|placebo HFA pMDI x 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI x 2 inhalations)
343004|NCT01136655|O1|Outcome|BUD 160/FM 2.25|2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI x 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations
343005|NCT01136655|O5|Outcome|BUD 160/ Foradil 12.0|Foradil Aerolizer 12 μg x 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
343006|NCT01136655|O4|Outcome|BUD 160|placebo HFA pMDI x 1 inhalation + 80 μg budesonide HFA pMDI x 2 inhalations
343007|NCT01136655|O3|Outcome|BUD 160/FM 9.0|placebo HFA pMDI x 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI x 2 inhalations)
343008|NCT01136655|O2|Outcome|BUD 160/FM 4.5|placebo HFA pMDI x 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI x 2 inhalations)
343009|NCT01136655|O1|Outcome|BUD 160/FM 2.25|2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI x 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations
343010|NCT01136655|O5|Outcome|BUD 160/ Foradil 12.0|Foradil Aerolizer 12 μg x 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
343011|NCT01136655|O4|Outcome|BUD 160|placebo HFA pMDI x 1 inhalation + 80 μg budesonide HFA pMDI x 2 inhalations
343012|NCT01136655|O3|Outcome|BUD 160/FM 9.0|placebo HFA pMDI x 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI x 2 inhalations)
343013|NCT01136655|O2|Outcome|BUD 160/FM 4.5|placebo HFA pMDI x 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI x 2 inhalations)
343014|NCT01136655|O1|Outcome|BUD 160/FM 2.25|2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI x 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations
343015|NCT01136655|E5|Reported Event|BUD 160/ Foradil 12.0|Foradil Aerolizer 12 μg x 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
343016|NCT01136655|E4|Reported Event|BUD 160|placebo HFA pMDI x 1 inhalation + 80 μg budesonide HFA pMDI x 2 inhalations
343017|NCT01136655|E3|Reported Event|BUD 160/FM 9.0|placebo HFA pMDI x 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI x 2 inhalations)
343018|NCT01136655|E2|Reported Event|BUD 160/FM 4.5|placebo HFA pMDI x 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI x 2 inhalations)
343019|NCT01136655|E1|Reported Event|BUD 160/FM 2.25|2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI x 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations
343020|NCT01136486|B1|Baseline|Level of Severity of TBI|Four categories based on pain severity (no pain, mild, moderate and severe pain).
343021|NCT01136486|P1|Participant Flow|Treatment Arm|Pain was assessed with the Visual Analog Scale and patients underwent a brief battery of tests that included assessment of neuropsychological functions, mood, anxiety and community functions.
343022|NCT01136486|O1|Outcome|Severity of Pain by Severity of Injury|
343023|NCT01136486|E1|Reported Event|Severity of Pain by Severity of Injury|
343024|NCT01136408|B4|Baseline|Total|Total of all reporting groups
343025|NCT01136408|B3|Baseline|Warfarin|Dose-adjusted warfarin based on target INR values
343026|NCT01136408|B2|Baseline|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
343027|NCT01136408|B1|Baseline|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
343028|NCT01136408|P3|Participant Flow|Warfarin|Dose-adjusted warfarin based on target INR values
343029|NCT01136408|P2|Participant Flow|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
343030|NCT01136408|P1|Participant Flow|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
343091|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
343032|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|"Dabigatran etexilate 150 mg capsule, twice a day, oral administration~Dabigatran etexilate: Dabigatran etexilate 150 mg capsule, twice a day, oral administration"
343033|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|"Dabigatran etexilate 110 mg capsule, twice a day, oral administration~Dabigatran etexilate: Dabigatran etexilate 110 mg capsule, twice a day, oral administration"
343034|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
343035|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
343036|NCT01136408|O3|Outcome|Warfarin|
343037|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
343038|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
343039|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
343040|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
343041|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
343042|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
343043|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
343044|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
343045|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
343046|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
343047|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
343048|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
343049|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
343050|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
343051|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
343052|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
343053|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
343054|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
343055|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
343056|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
343057|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
343058|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
343059|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
343060|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
343061|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
343062|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
343063|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
343064|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
343065|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
343066|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
343067|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
343068|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
343069|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
343070|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
343071|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
343072|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
343073|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
343074|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
343075|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
343076|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
343077|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
343078|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
343079|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
343080|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
343081|NCT01136408|E3|Reported Event|Warfarin|Dose-adjusted warfarin based on target INR values
343082|NCT01136408|E2|Reported Event|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
343083|NCT01136408|E1|Reported Event|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
343084|NCT01136382|B3|Baseline|Total|Total of all reporting groups
343113|NCT01136356|B1|Baseline|Within Subjects Design|Participants received both study drugs (buprenorphine and morphine) in a randomized sequence.
343114|NCT01136356|P2|Participant Flow|Buprenorphine First, Then Morphine|Participants randomized to receive buprenorphine (32 mg/day i.m.) administered in four divide doses for 9 days. Then underwent an 18-day period of spontaneous withdrawal, during which 4 double blind i.m. placebo injections were administered daily. Then administered using morphine (120 mg/day i.m.) with the same time course
343115|NCT01136356|P1|Participant Flow|Morphine First, Then Buprenorphine|Participants randomized to receive morphine (120 mg/day i.m.) administered in four divide doses for 9 days. Then underwent an 18-day period of spontaneous withdrawal, during which 4 double blind i.m. placebo injections were administered daily. Then administered using buprenorphine (32 mg/day i.m.) with the same time course
343116|NCT01136356|O2|Outcome|Buprenorphine|
343117|NCT01136356|O1|Outcome|Morphine|
343118|NCT01136356|O2|Outcome|Buprenorphine|
343119|NCT01136356|O1|Outcome|Morphine|
343120|NCT01136356|O2|Outcome|Buprenorphine|
343121|NCT01136356|O1|Outcome|Morphine|
343122|NCT01136356|E1|Reported Event|All Participants|The adverse events were not specified per drug intervention, therefore, the adverse events per interventions is unknown. The data below references the adverse events recorded by licensed nursing personnel during the participants' 59-day protocol in a residential research unit. All participants (N=7) were randomized to receive either buprenorphine (32 mg/day i.m.) or morphine (120 mg/day i.m.) administered in four divided doses each day for 9 days (8 mg of buprenorphine four times per day, or 30 mg of morphine four times per day). Participants then underwent an 18-day period of spontaneous opioid withdrawal, during which four double blind i.m. placebo injections were administered daily. After the period of spontaneous withdrawal, participants received the second opioid administration and spontaneous withdrawal period using the same time course described above.
343123|NCT01136291|B3|Baseline|Total|Total of all reporting groups
343124|NCT01136291|B2|Baseline|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
343125|NCT01136291|B1|Baseline|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.~The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.~These women also received nutrition and prenatal care."
343126|NCT01136291|P2|Participant Flow|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
343127|NCT01136291|P1|Participant Flow|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.~The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.~These women also received nutrition and prenatal care."
343128|NCT01136291|O2|Outcome|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
343129|NCT01136291|O1|Outcome|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.~The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.~These women also received nutrition and prenatal care."
343130|NCT01136291|O2|Outcome|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
343131|NCT01136291|O1|Outcome|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.~The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.~These women also received nutrition and prenatal care."
343132|NCT01136291|O2|Outcome|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
343133|NCT01136291|O1|Outcome|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.~The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.~These women also received nutrition and prenatal care."
343134|NCT01136291|E2|Reported Event|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
343135|NCT01136291|E1|Reported Event|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.~The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.~These women also received nutrition and prenatal care."
343136|NCT01136226|B1|Baseline|Single Arm- Eligard|Eligard 22.5mg is only intervention administered
343137|NCT01136226|P1|Participant Flow|Single Arm- Eligard|Eligard 22.5mg is only intervention administered
343138|NCT01136226|O1|Outcome|Single Arm- Eligard|Eligard 22.5mg is only intervention administered
343139|NCT01136226|E1|Reported Event|Single Arm- Eligard|Eligard 22.5mg is only intervention administered
343140|NCT01136174|B5|Baseline|Total|Total of all reporting groups
343141|NCT01136174|B4|Baseline|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
343142|NCT01136174|B3|Baseline|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
343143|NCT01136174|B2|Baseline|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
343144|NCT01136174|B1|Baseline|Placebo|Placebo oral administration twice a day
343145|NCT01136174|P4|Participant Flow|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
352887|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
343146|NCT01136174|P3|Participant Flow|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
343147|NCT01136174|P2|Participant Flow|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
343148|NCT01136174|P1|Participant Flow|Placebo|Placebo oral administration twice a day
343149|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
343150|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
343151|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
343152|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
343153|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
343154|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
343155|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
343156|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
343157|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
343158|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
343159|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
343160|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
343161|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
343162|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
343163|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
343164|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day for cohort 2
343165|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day for cohort 1
343166|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 1, 2, 3
343167|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
343168|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day for cohort 2
343169|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day for cohort 1
343170|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 1, 2, 3
343171|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
343172|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day for cohort 2
343173|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day for cohort 1
343174|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 1, 2, 3
343175|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
343176|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
343177|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
343178|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
343179|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
343180|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
343181|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
343182|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
343183|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
343184|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
343185|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
343186|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
343187|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
343188|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
343189|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
343190|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
343191|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
343192|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
343193|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
343194|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
343195|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
343196|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
343197|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
343198|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
343199|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
343200|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
343201|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
343202|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
343203|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
343204|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
343205|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
343206|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
343207|NCT01136174|O3|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
343208|NCT01136174|O2|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
343209|NCT01136174|O1|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
343210|NCT01136174|O3|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
343211|NCT01136174|O2|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
343212|NCT01136174|O1|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
343213|NCT01136174|O3|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
343214|NCT01136174|O2|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
343215|NCT01136174|O1|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
343216|NCT01136174|O3|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
343217|NCT01136174|O2|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
343218|NCT01136174|O1|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
343219|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
343220|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
343221|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
343222|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
343223|NCT01136174|E4|Reported Event|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
343224|NCT01136174|E3|Reported Event|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day for cohort 2
343225|NCT01136174|E2|Reported Event|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day for cohort 1
343226|NCT01136174|E1|Reported Event|Placebo|Placebo oral administration twice a day for cohort 1, 2, 3
343227|NCT01135992|B1|Baseline|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
343228|NCT01135992|P1|Participant Flow|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
343229|NCT01135992|O1|Outcome|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
343230|NCT01135992|O1|Outcome|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
343231|NCT01135992|O1|Outcome|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
343232|NCT01135992|O1|Outcome|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
343233|NCT01135992|O1|Outcome|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
343234|NCT01135992|O1|Outcome|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
343235|NCT01135992|E1|Reported Event|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
343236|NCT01135914|B4|Baseline|Total|Total of all reporting groups
343237|NCT01135914|B3|Baseline|Laser Monotherapy|Participants received Laser photocoagulation therapy only
343238|NCT01135914|B2|Baseline|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
343239|NCT01135914|B1|Baseline|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
343240|NCT01135914|P3|Participant Flow|Laser Monotherapy|Participants received Laser photocoagulation therapy only
343241|NCT01135914|P2|Participant Flow|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
343242|NCT01135914|P1|Participant Flow|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
343243|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
343244|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
343245|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
343246|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
343247|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
343248|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
343249|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
343250|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
343251|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
343252|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
343253|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
343254|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
352888|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
343255|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
343256|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
343257|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
343258|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
343259|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
343260|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
343261|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
343262|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
343263|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
343264|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
343265|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
343266|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
343267|NCT01135914|E3|Reported Event|Laser Monotherapy|Participants received Laser photocoagulation therapy only
343268|NCT01135914|E2|Reported Event|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
343269|NCT01135914|E1|Reported Event|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
343270|NCT01135524|B1|Baseline|Extension Phase|Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear
343271|NCT01135524|P1|Participant Flow|Extension Phase|Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear
343272|NCT01135524|O1|Outcome|Extension Phase|Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear
343273|NCT01135524|E1|Reported Event|Extension Phase|Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear
343274|NCT01135511|B10|Baseline|Total|Total of all reporting groups
343275|NCT01135511|B9|Baseline|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343276|NCT01135511|B8|Baseline|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343277|NCT01135511|B7|Baseline|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343278|NCT01135511|B6|Baseline|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343279|NCT01135511|B5|Baseline|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343280|NCT01135511|B4|Baseline|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343281|NCT01135511|B3|Baseline|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343282|NCT01135511|B2|Baseline|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343283|NCT01135511|B1|Baseline|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343284|NCT01135511|P9|Participant Flow|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343285|NCT01135511|P8|Participant Flow|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343584|NCT01135420|B1|Baseline|Usual Care|"Psychiatry inpatient usual care~Usual care: All patients in the trial will receive usual care (i.e., the care they would have received in the absence of a study)."
343641|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
343286|NCT01135511|P7|Participant Flow|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343287|NCT01135511|P6|Participant Flow|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343288|NCT01135511|P5|Participant Flow|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343289|NCT01135511|P4|Participant Flow|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343290|NCT01135511|P3|Participant Flow|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343291|NCT01135511|P2|Participant Flow|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343292|NCT01135511|P1|Participant Flow|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343293|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343294|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343295|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343296|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343297|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343298|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343299|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343300|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343301|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343302|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343303|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343304|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343305|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343306|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343307|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343308|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343309|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343310|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343311|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343312|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343313|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343314|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343315|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343316|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343317|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343318|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343319|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343320|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343321|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343322|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343323|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
352889|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
343324|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343325|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343326|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343327|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343328|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343329|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343330|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343331|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343332|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343333|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343334|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343335|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343336|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343337|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343338|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343339|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343340|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343341|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343342|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343628|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
343343|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343344|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343345|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343346|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343347|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343348|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343349|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343350|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343351|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343352|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343353|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343354|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343355|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343356|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343357|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343358|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343359|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343360|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343361|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343629|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
343362|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343363|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343364|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343365|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343366|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343367|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343368|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343369|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343370|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343371|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343372|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343373|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343374|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343375|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343376|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343377|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343378|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343379|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343380|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
352890|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
343381|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343382|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343383|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343384|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343385|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343386|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343387|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343388|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343389|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343390|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343391|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343392|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343393|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343394|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343395|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343396|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343397|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343398|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343399|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
352891|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
343400|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343401|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343402|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343403|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343404|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343405|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343406|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343407|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343408|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343409|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343410|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343411|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343412|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343413|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343414|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343415|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343416|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343417|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343418|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
352892|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
343419|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343420|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343421|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343422|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343423|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343424|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343425|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343426|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343427|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343428|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343429|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343430|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343431|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343432|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343433|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343434|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343435|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343436|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343437|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343630|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
343438|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343439|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343440|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343441|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343442|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343443|NCT01135511|O9|Outcome|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343444|NCT01135511|O8|Outcome|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343445|NCT01135511|O7|Outcome|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343446|NCT01135511|O6|Outcome|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343447|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343448|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343449|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343450|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343451|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343452|NCT01135511|O9|Outcome|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343453|NCT01135511|O8|Outcome|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343454|NCT01135511|O7|Outcome|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343455|NCT01135511|O6|Outcome|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343456|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343631|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
343457|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343458|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343459|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343460|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343461|NCT01135511|O9|Outcome|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343462|NCT01135511|O8|Outcome|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343463|NCT01135511|O7|Outcome|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343464|NCT01135511|O6|Outcome|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343465|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343466|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343467|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343468|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343469|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343470|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343471|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343472|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343473|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343474|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343475|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343632|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
343476|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343477|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343478|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343479|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343480|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343481|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343482|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343483|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343484|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343485|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343486|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343487|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343488|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343489|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343490|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343491|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343492|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343493|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343494|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343633|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
343495|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343496|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343497|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343498|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343499|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343500|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343501|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343502|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343503|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343504|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343505|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343506|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343507|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343508|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343509|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343510|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343511|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343512|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343513|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343634|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
343514|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343515|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343516|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343517|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343518|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343519|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343520|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343521|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343522|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343523|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343524|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343525|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343526|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343527|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343528|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343529|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343530|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343531|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343532|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
352893|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
343533|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343534|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343535|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343536|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343537|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343538|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343539|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343540|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343541|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343542|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343543|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343544|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343545|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343546|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343547|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343548|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343549|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343550|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343551|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
352894|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
343552|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343553|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343554|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343555|NCT01135511|O9|Outcome|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343556|NCT01135511|O8|Outcome|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343557|NCT01135511|O7|Outcome|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343558|NCT01135511|O6|Outcome|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343559|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343560|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343561|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343562|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343563|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343564|NCT01135511|E9|Reported Event|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343565|NCT01135511|E8|Reported Event|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343566|NCT01135511|E7|Reported Event|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343567|NCT01135511|E6|Reported Event|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343568|NCT01135511|E5|Reported Event|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
343569|NCT01135511|E4|Reported Event|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343570|NCT01135511|E3|Reported Event|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343571|NCT01135511|E2|Reported Event|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343572|NCT01135511|E1|Reported Event|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
343573|NCT01135498|B1|Baseline|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
343574|NCT01135498|P1|Participant Flow|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) and oxaliplatin 130 mg per square meter (mg/m^2) IV on Day 1 and capecitabine 1000 mg/m^2, tablet, orally (PO), every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
343575|NCT01135498|O1|Outcome|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
343576|NCT01135498|O1|Outcome|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
343577|NCT01135498|O1|Outcome|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"ACycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
343578|NCT01135498|O1|Outcome|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
343579|NCT01135498|O1|Outcome|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
343580|NCT01135498|O1|Outcome|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
343581|NCT01135498|E1|Reported Event|Bevacizumab+Eloxatin+Capecitabine/Bevacizumab+Erlotinib|A cycle was defined as the following: participants received 7.5 mg/kg bevacizumab, IV on Day 1; 130 mg/m^2 eloxatin tablets, orally, on Days 1 through 14; and 1000 mg/m^2 capecitabine tablets, orally, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles. If all 6 cycles were tolerated with no disease progression, participants then received 7.5 mg/kg bevacizumab, IV on Day 1 and 150 mg erlotinib tablets, orally, once daily. This cycle was repeated every 3 weeks until disease progression.
343582|NCT01135420|B3|Baseline|Total|Total of all reporting groups
343583|NCT01135420|B2|Baseline|Telephone Monitoring|"Patients in the TM condition received an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention will incorporate motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation.~Telephone Monitoring (TM) with Motivational Interviewing: Patients in the TM condition will receive an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention will have a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition is to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety"
343635|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
343585|NCT01135420|P2|Participant Flow|Telephone Monitoring|"Patients in the TM condition received an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention incorporated motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation.~Telephone Monitoring (TM) with Motivational Interviewing: Patients in the TM condition received an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention had a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition was to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety."
343586|NCT01135420|P1|Participant Flow|Usual Care|"Psychiatry inpatient usual care~Usual care: All patients in the trial received usual care (i.e., the care they would have received in the absence of a study)."
343587|NCT01135420|O2|Outcome|Telephone Monitoring|"Patients in the TM condition received an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention will incorporate motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation.~Telephone Monitoring (TM) with Motivational Interviewing: Patients in the TM condition will receive an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention will have a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition is to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety."
343588|NCT01135420|O1|Outcome|Usual Care|"Psychiatry inpatient usual care~Usual care: All patients in the trial will receive usual care (i.e., the care they would have received in the absence of a study)."
343589|NCT01135420|E2|Reported Event|Telephone Monitoring|"Patients in the TM condition received an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention will incorporate motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation.~Telephone Monitoring (TM) with Motivational Interviewing: Patients in the TM condition will receive an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention will have a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition is to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety."
343590|NCT01135420|E1|Reported Event|Usual Care|"Psychiatry inpatient usual care~Usual care: All patients in the trial will receive usual care (i.e., the care they would have received in the absence of a study)."
343591|NCT01135381|B5|Baseline|Total|Total of all reporting groups
343592|NCT01135381|B4|Baseline|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
343593|NCT01135381|B3|Baseline|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
343594|NCT01135381|B2|Baseline|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
343595|NCT01135381|B1|Baseline|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
343596|NCT01135381|P4|Participant Flow|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
343597|NCT01135381|P3|Participant Flow|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
343598|NCT01135381|P2|Participant Flow|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
343599|NCT01135381|P1|Participant Flow|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
343600|NCT01135381|O4|Outcome|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
343636|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
343637|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
343638|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
343639|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
343640|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
343601|NCT01135381|O3|Outcome|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
343602|NCT01135381|O2|Outcome|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
343603|NCT01135381|O1|Outcome|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
343604|NCT01135381|O4|Outcome|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
343605|NCT01135381|O3|Outcome|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
343606|NCT01135381|O2|Outcome|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
343607|NCT01135381|O1|Outcome|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
343608|NCT01135381|O4|Outcome|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
343609|NCT01135381|O3|Outcome|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
343610|NCT01135381|O2|Outcome|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
343611|NCT01135381|O1|Outcome|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
343612|NCT01135381|E4|Reported Event|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
343613|NCT01135381|E3|Reported Event|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
343614|NCT01135381|E2|Reported Event|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
343615|NCT01135381|E1|Reported Event|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
343616|NCT01135368|B1|Baseline|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
343617|NCT01135368|P1|Participant Flow|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
343618|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
343619|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
343620|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
343621|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
343622|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
343623|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
343624|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
343625|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
343626|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
343627|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
343642|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
343643|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
343644|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
343645|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
343646|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
343647|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
343648|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
343649|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
343650|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
343651|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
343652|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
343653|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
343654|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
343655|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
343656|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
343657|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
343658|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
343659|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
343660|NCT01135368|O3|Outcome|Pathological|Participants with pathological color vision at Baseline.
343661|NCT01135368|O2|Outcome|Normal|Participants with normal color vision at Baseline.
343662|NCT01135368|O1|Outcome|No Data|Participants with no color vision data at Baseline.
343663|NCT01135368|O1|Outcome|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
343664|NCT01135368|O4|Outcome|Normal|Participants with adaptation classified as normal at Baseline.
343665|NCT01135368|O3|Outcome|Pathological|Participants with adaptation classified as pathological at Baseline.
343666|NCT01135368|O2|Outcome|Decreased Due to Age|Participants with adaptation decreased due to age at Baseline.
343667|NCT01135368|O1|Outcome|Missing Data|Participants with no data at Baseline.
343668|NCT01135368|O4|Outcome|Normal|Participants with adaptation classified as normal at Baseline.
343669|NCT01135368|O3|Outcome|Pathological|Participants with adaptation classified as pathological at Baseline.
343670|NCT01135368|O2|Outcome|Decreased Due to Age|Participants with adaptation decreased due to age at Baseline.
343671|NCT01135368|O1|Outcome|Missing Data|Participants with no data at Baseline.
343672|NCT01135368|O1|Outcome|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
343673|NCT01135368|O1|Outcome|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
343674|NCT01135368|O1|Outcome|Lansoprazole|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks. Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months.
343675|NCT01135368|O1|Outcome|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
343676|NCT01135368|O5|Outcome|No Data|Participants with no intestinal metaplasia data at Baseline.
343677|NCT01135368|O4|Outcome|Severe|Participants with severe intestinal metaplasia at Baseline.
343678|NCT01135368|O3|Outcome|Moderate|Participants with moderate intestinal metaplasia at Baseline.
343679|NCT01135368|O2|Outcome|Mild|Participants with mild intestinal metaplasia at Baseline.
343680|NCT01135368|O1|Outcome|None|Participants with no intestinal metaplasia at Baseline.
343681|NCT01135368|O5|Outcome|No Data|Participants with no intestinal metaplasia data at Baseline.
343682|NCT01135368|O4|Outcome|Severe|Participants with severe intestinal metaplasia at Baseline.
343683|NCT01135368|O3|Outcome|Moderate|Participants with moderate intestinal metaplasia at Baseline.
343684|NCT01135368|O2|Outcome|Mild|Participants with mild intestinal metaplasia at Baseline.
343685|NCT01135368|O1|Outcome|None|Participants with no intestinal metaplasia at Baseline.
343686|NCT01135368|O1|Outcome|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
343687|NCT01135368|O1|Outcome|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
343688|NCT01135368|O5|Outcome|No Data|Participants with no data at Baseline.
343689|NCT01135368|O4|Outcome|Severe|Participants with severe atrophy at Baseline.
343690|NCT01135368|O3|Outcome|Moderate|Participants with moderate atrophy at Baseline.
343691|NCT01135368|O2|Outcome|Mild|Participants with mild atrophy at Baseline.
343692|NCT01135368|O1|Outcome|No Atrophy|Participants with no atrophy at Baseline.
343693|NCT01135368|O5|Outcome|No Data|Participants with no data at Baseline.
343694|NCT01135368|O4|Outcome|Severe|Participants with severe atrophy at Baseline.
343695|NCT01135368|O3|Outcome|Moderate|Participants with moderate atrophy at Baseline.
343696|NCT01135368|O2|Outcome|Mild|Participants with mild atrophy at Baseline.
343697|NCT01135368|O1|Outcome|No Atrophy|Participants with no atrophy at Baseline.
343698|NCT01135368|O4|Outcome|No Data|Participants with no data at Baseline.
343699|NCT01135368|O3|Outcome|Linear|Participants with linear, chain producing hyperplasia at Baseline.
352895|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
343700|NCT01135368|O2|Outcome|Simple|Participants with simple (diffuse) hyperplasia at Baseline.
343701|NCT01135368|O1|Outcome|Normal|Participants with normal ECL cell classification at Baseline.
343702|NCT01135368|O5|Outcome|Grade D|Participants with Grade D (mucosal breaks which involve at least 75% of the oesophageal circumference) at Baseline.
343703|NCT01135368|O4|Outcome|Grade C|Participants with Grade C (mucosal breaks that extend between the tops of two or more mucosal folds, but which involve less than 75% of the oesophageal circumference) at Baseline.
343704|NCT01135368|O3|Outcome|Grade B|Participants with Grade B (one or more mucosal breaks more than 5 mm long, none of which extends between the tops of two mucosal folds) at Baseline.
343705|NCT01135368|O2|Outcome|Grade A|Participants with Grade A (one or more mucosal breaks no longer than 5 mm, none of which extends between the tops of the mucosal folds) at Baseline.
343706|NCT01135368|O1|Outcome|Grade 0|Participants with Grade 0 (normal aspect of mucosa) at Baseline.
343707|NCT01135368|O4|Outcome|Severe|Participants with severe symptoms at Baseline.
343708|NCT01135368|O3|Outcome|Moderate|Participants with moderate symptoms at Baseline.
343709|NCT01135368|O2|Outcome|Mild|Participants with mild symptoms at Baseline.
343710|NCT01135368|O1|Outcome|None|Participants with no symptoms at Baseline.
343711|NCT01135368|O4|Outcome|Severe|Participants with severe symptoms at Baseline.
343712|NCT01135368|O3|Outcome|Moderate|Participants with moderate symptoms at Baseline.
343713|NCT01135368|O2|Outcome|Mild|Participants with mild symptoms at Baseline.
343714|NCT01135368|O1|Outcome|None|Participants with no symptoms at Baseline.
343715|NCT01135368|O4|Outcome|Severe|Participants with severe symptoms at Baseline.
343716|NCT01135368|O3|Outcome|Moderate|Participants with moderate symptoms at Baseline.
343717|NCT01135368|O2|Outcome|Mild|Participants with mild symptoms at Baseline.
343718|NCT01135368|O1|Outcome|None|Participants with no symptoms at Baseline.
343719|NCT01135368|O4|Outcome|Severe|Participants with severe symptoms at Baseline.
343720|NCT01135368|O3|Outcome|Moderate|Participants with moderate symptoms at Baseline.
343721|NCT01135368|O2|Outcome|Mild|Participants with mild symptoms at Baseline.
343722|NCT01135368|O1|Outcome|None|Participants with no symptoms at Baseline.
343723|NCT01135368|O4|Outcome|Severe|Participants with severe symptoms at Baseline.
343724|NCT01135368|O3|Outcome|Moderate|Participants with moderate symptoms at Baseline.
343725|NCT01135368|O2|Outcome|Mild|Participants with mild symptoms at Baseline.
343726|NCT01135368|O1|Outcome|None|Participants with no symptoms at Baseline.
343727|NCT01135368|O4|Outcome|Severe|Participants with severe symptoms at Baseline.
343728|NCT01135368|O3|Outcome|Moderate|Participants with moderate symptoms at Baseline.
343729|NCT01135368|O2|Outcome|Mild|Participants with mild symptoms at Baseline.
343730|NCT01135368|O1|Outcome|None|Participants with no symptoms at Baseline.
343731|NCT01135368|E1|Reported Event|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
343732|NCT01135186|B1|Baseline|Open Label Study|"sapropterin dihydrochloride~sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day (week 1 through week 4)~sapropterin dihydrochloride: sapropterin dihydrochloride: 20mg/kg/day (week 5 through week 8)"
343733|NCT01135186|P1|Participant Flow|Open Label Study|"sapropterin dihydrochloride~sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day"
343734|NCT01135186|O1|Outcome|Open Label Study|"sapropterin dihydrochloride~sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day week 1-4, 20mg/kg/day week 5-8."
343735|NCT01135186|O1|Outcome|Open Label Study|"sapropterin dihydrochloride~sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day weeks (1-4) and 20mg/kg/days weeks (week 5-8)"
343736|NCT01135186|O1|Outcome|Open Label Study|"sapropterin dihydrochloride~sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day week 1-4, 20mg/kg/day week 5-8."
343737|NCT01135186|O1|Outcome|Open Label Study|"sapropterin dihydrochloride~sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day"
343738|NCT01135186|E1|Reported Event|Open Label Study|"sapropterin dihydrochloride~sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day (week 1-4) 20 mg/kg/day (week 5-8)"
343739|NCT01135134|B3|Baseline|Total|Total of all reporting groups
343740|NCT01135134|B2|Baseline|Placebo|"Placebo MFNS. Administration was as follows:~5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks."
343741|NCT01135134|B1|Baseline|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:~5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks."
343742|NCT01135134|P2|Participant Flow|Placebo|"Placebo MFNS. Administration was as follows:~5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks."
343743|NCT01135134|P1|Participant Flow|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:~5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks."
343744|NCT01135134|O2|Outcome|Placebo|"Placebo MFNS. Administration was as follows:~5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks."
343745|NCT01135134|O1|Outcome|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:~5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks."
343746|NCT01135134|O2|Outcome|Placebo|"Placebo MFNS. Administration was as follows:~5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks."
343915|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
343747|NCT01135134|O1|Outcome|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:~5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks."
343748|NCT01135134|E2|Reported Event|Placebo|"Placebo MFNS. Administration was as follows:~5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks."
343749|NCT01135134|E1|Reported Event|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:~5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks."
343750|NCT01135069|B4|Baseline|Total|Total of all reporting groups
343751|NCT01135069|B3|Baseline|Placebo|Microsphere Gel no active
343752|NCT01135069|B2|Baseline|Brand|Retin-A Micro 0.1%
343753|NCT01135069|B1|Baseline|Generic|Tretinoin Microsphere Gel 0.1%
343754|NCT01135069|P3|Participant Flow|Placebo|Microsphere Gel no active
343755|NCT01135069|P2|Participant Flow|Brand|Retin-A Micro 0.1%
343756|NCT01135069|P1|Participant Flow|Generic|Tretinoin Microsphere Gel 0.1%
343757|NCT01135069|O3|Outcome|Placebo|"Treatment of acne for 12 weeks~Percent change (reduction) in acne lesions was 58% reduction"
343758|NCT01135069|O2|Outcome|Brand|"Treatment of acne for 12 weeks~Percent change (reduction) in acne lesions was 76% reduction"
343759|NCT01135069|O1|Outcome|Generic|"treatment of acne for 12 weeks~Percent change (reduction) in acne lesions was 74% reduction."
343760|NCT01135069|E3|Reported Event|Placebo|Microsphere Gel no active
343761|NCT01135069|E2|Reported Event|Brand|Retin-A Micro 0.1%
343762|NCT01135069|E1|Reported Event|Generic|Tretinoin Microsphere Gel 0.1%
343763|NCT01135017|B3|Baseline|Total|Total of all reporting groups
343764|NCT01135017|B2|Baseline|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
343765|NCT01135017|B1|Baseline|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
343766|NCT01135017|P2|Participant Flow|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
343767|NCT01135017|P1|Participant Flow|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
343768|NCT01135017|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
343769|NCT01135017|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
343770|NCT01135017|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
343771|NCT01135017|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
343772|NCT01135017|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
343773|NCT01135017|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
343774|NCT01135017|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
343775|NCT01135017|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
343776|NCT01135017|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
343777|NCT01135017|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
343778|NCT01135017|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
343779|NCT01135017|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
343780|NCT01135017|E2|Reported Event|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
343781|NCT01135017|E1|Reported Event|Placebo|Placebo (for dronedarone) twice a day for 12 weeks
343782|NCT01134952|B1|Baseline|MMF MRL Switch|Liver transplant recipients with Hepatitis C virus switched from mycophenolate mofetil (MMF) to sirolimus (SRL) for 3 months and then switched back to MMF
343783|NCT01134952|P1|Participant Flow|MMF SRL Switch|Liver transplant recipients with Hepatitis C virus taking sirolimus (SRL) instead of mycophenolate mofetil (MMF) for 3 months
343784|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
343785|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
343786|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
343787|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
343788|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
343789|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
343790|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
343791|NCT01134952|O1|Outcome|MMF SRL Switch|Liver transplant recipients switched from mycophenolate mofetil to sirolimus
343792|NCT01134952|O1|Outcome|MMF SRL Switch|All patients after switch from mycophenolate to sirolimus
343793|NCT01134952|O1|Outcome|MMF SRL Switch|All patients switched for 3 months from mycophenolate mofetil to sirolimus and then back to mycophenolate mofetil
343794|NCT01134952|O1|Outcome|MMF SRL Switch|Liver transplant recipients with HCV 3 months after switch from mycophenolate to sirolimus
343795|NCT01134952|E1|Reported Event|MMF SRL Switch|All patients during 3 month period of switch from mycophenolate mofetil (MMF) to sirolimus and for 3 months after switch back to MMF
343796|NCT01134939|B9|Baseline|Total|Total of all reporting groups
343797|NCT01134939|B8|Baseline|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343798|NCT01134939|B7|Baseline|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343799|NCT01134939|B6|Baseline|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343800|NCT01134939|B5|Baseline|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343801|NCT01134939|B4|Baseline|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343802|NCT01134939|B3|Baseline|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343803|NCT01134939|B2|Baseline|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
343804|NCT01134939|B1|Baseline|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
343805|NCT01134939|P8|Participant Flow|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343806|NCT01134939|P7|Participant Flow|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343807|NCT01134939|P6|Participant Flow|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343808|NCT01134939|P5|Participant Flow|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343809|NCT01134939|P4|Participant Flow|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343810|NCT01134939|P3|Participant Flow|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343811|NCT01134939|P2|Participant Flow|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
343812|NCT01134939|P1|Participant Flow|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
343813|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343814|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343815|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343816|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343817|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343818|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343819|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
343820|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
343821|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343822|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343823|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343824|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343825|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343826|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343827|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
343828|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
343829|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343830|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343831|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343832|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343833|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343834|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343835|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
343836|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
343837|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343838|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343839|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343840|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343841|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343842|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343843|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
343844|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
343845|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343846|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343847|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343848|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343849|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343850|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343851|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
343852|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
343853|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343854|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343855|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343856|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343857|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343858|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343859|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
343860|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
343861|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343862|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343863|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343864|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343865|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343866|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343867|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
343868|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
343869|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343870|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343871|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343872|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343873|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343874|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343875|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
343876|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
343877|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343878|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343879|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343880|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343881|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343882|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343883|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
343884|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
343885|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343886|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343887|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343888|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343889|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343890|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343891|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
343892|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
343893|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343894|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343895|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343896|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343897|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343898|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343899|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
343900|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
343901|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343902|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343903|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343904|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343905|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343906|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343907|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
343908|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
343909|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343910|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343911|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343912|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343913|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343914|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
352896|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
343916|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
343917|NCT01134939|E4|Reported Event|Patients With Baseline Viral Load Not Documented|Female and male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
343918|NCT01134939|E3|Reported Event|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Female and male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
343919|NCT01134939|E2|Reported Event|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Female and male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
343920|NCT01134939|E1|Reported Event|Treatment-naive Patients|Female and male patients who were not pretreated with HIV therapy.
343921|NCT01134900|B3|Baseline|Total|Total of all reporting groups
343922|NCT01134900|B2|Baseline|Control|Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
343923|NCT01134900|B1|Baseline|Dashboard|Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
343924|NCT01134900|P2|Participant Flow|Control|Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
343925|NCT01134900|P1|Participant Flow|Dashboard|Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
343926|NCT01134900|O2|Outcome|Control|Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
343927|NCT01134900|O1|Outcome|Dashboard|Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
343928|NCT01134900|O2|Outcome|Control|Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
343929|NCT01134900|O1|Outcome|Dashboard|Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
343930|NCT01134900|E2|Reported Event|Control|Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
343931|NCT01134900|E1|Reported Event|Dashboard|Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
343932|NCT01134887|B5|Baseline|Total|Total of all reporting groups
343933|NCT01134887|B4|Baseline|Arm 4: Control-Physician|"Primary care providers randomly assigned to the Control-Physicians arm of the study did not receive coaching or additional resources, and conducted their primary care practice as usual."
343934|NCT01134887|B3|Baseline|Arm 3: Intervention-Physician|"Primary care providers randomly assigned to the Intervention-Physicians arm of this study received a copy of the Four Habits of Highly Effective Physicians. The Four Habits provided practical evidence-based advice for improving patient-physician communication. Second, physicians participated in an audiotaped intensive 30 minute, one-on-one educational intervention with PI Frankel after their first set of visits from their three participating patients, but before seeing them for follow-ups. The main goal of this meeting was to review and discuss the analysis of the physician's videotaped visits using the Four Habits framework, with a particular focus on improving communication about self-management."
343935|NCT01134887|B2|Baseline|Arm 2: Control-Veteran|"Veterans enrolled in the Control-Veterans arm received a copy of the NIA guide for Talking with Your Doctor.” This pamphlet was specifically developed for this purpose (updated in 2002). It has pictorials and is written at an 8th grade level."
343936|NCT01134887|B1|Baseline|Arm 1: Intervention-Veteran|"Veterans enrolled in the Intervention-Veterans arm received a copy of the NIA guide for Talking with Your Doctor. Just prior to their next scheduled visit an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor. To facilitate communication change, the educator assisted the patient in setting a goal to achieve during their visit. The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management."
343937|NCT01134887|P4|Participant Flow|Arm 4: Control-Physician|"Primary care providers randomly assigned to the Control-Physicians arm of the study did not receive coaching or additional resources, and conducted their primary care practice as usual."
343938|NCT01134887|P3|Participant Flow|Arm 3: Intervention-Physician|"Primary care providers randomly assigned to the Intervention-Physicians arm of this study received a copy of the Four Habits of Highly Effective Physicians. The Four Habits provided practical evidence-based advice for improving patient-physician communication. Second, physicians participated in an audiotaped intensive 30 minute, one-on-one educational intervention with PI Frankel after their first set of visits from their three participating patients, but before seeing them for follow-ups. The main goal of this meeting was to review and discuss the analysis of the physician's videotaped visits using the Four Habits framework, with a particular focus on improving communication about self-management."
343939|NCT01134887|P2|Participant Flow|Arm 2: Control-Veteran|"Veterans enrolled in the Control-Veterans arm received a copy of the NIA guide for Talking with Your Doctor.” This pamphlet was specifically developed for this purpose (updated in 2002). It has pictorials and is written at an 8th grade level."
343940|NCT01134887|P1|Participant Flow|Arm 1: Intervention-Veteran|"Veterans enrolled in the Intervention-Veterans arm received a copy of the NIA guide for Talking with Your Doctor. Just prior to their next scheduled visit an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor. To facilitate communication change, the educator assisted the patient in setting a goal to achieve during their visit. The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management."
343941|NCT01134887|O2|Outcome|Arm 2: Control-Veterans|The attention control comparator consisted of giving Veterans a copy of the NIA guide for “Talking with Your Doctor.” This pamphlet was specifically developed for this purpose (updated in 2002). It has pictorials and is written at an 8th grade level.
343942|NCT01134887|O1|Outcome|Arm 1: Intervention-Veterans|Veterans randomized to the intervention group received a copy of the NIA guide for “Talking with Your Doctor.” Just prior to their next scheduled visit, an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor. Additional information was provided on how to be an active participant in the health care encounter and how to communicate effectively to promote productive self-management. To facilitate communication change, the educator assisted the Veteran in setting a goal to achieve during their visit. The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management.
343943|NCT01134887|E4|Reported Event|Arm 4: Control-Physicians|Control physicians were told to conduct their encounters as usual and were not given any coaching. Adverse event reporting was provided as part of the study.
343944|NCT01134887|E3|Reported Event|Arm 3: Intervention-Physicians|The 5 intervention arm physicians were coached in the Four Habits of Highly Effective Clinicians in a one hour face to face meeting involving review of the provider's interaction with his or her intervention patients and suggestions for improvement based on these observations.
343945|NCT01134887|E2|Reported Event|Arm 2: Attention Control|Veterans enrolled in the attention control arm received a copy of the NIA guide for “Talking with Your Doctor.” This pamphlet was specifically developed for this purpose (updated in 2002). It has pictorials and is written at an 8th grade level.
343946|NCT01134887|E1|Reported Event|Arm 1: Intervention|Veterans enrolled in the intervention arm received a copy of the NIA guide for “Talking with Your Doctor.” Just prior to their next scheduled visit an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor. Additional information was provided on how to be an active participant in the health care encounter and how to communicate effectively to promote productive self-management. To facilitate communication change, the educator assisted the patient in setting a goal to achieve during their visit. The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management.
343947|NCT01134783|B3|Baseline|Total|Total of all reporting groups
343948|NCT01134783|B2|Baseline|Intervention Group|This intervention arm is a combination of the face-to-face class students, hybrid class students and online class students
343949|NCT01134783|B1|Baseline|Control Group|This control group arm consists of students who served as the comparison group.
343950|NCT01134783|P2|Participant Flow|Control Group|217 participants were randomized to the control condition
343951|NCT01134783|P1|Participant Flow|Intervention Group|224 participants were randomized to the intervention condition
343952|NCT01134783|O2|Outcome|Control Group|Control group (serving as a comparison group)
343953|NCT01134783|O1|Outcome|Intervention Group|"The CHOICES intervention included a 1-credit, academic college course focusing on healthy weight behaviors and participation in a social networking and social support website~CHOICES Intervention: Academic course on healthy weight behaviors followed by participation in a social networking and social support website."
343954|NCT01134783|O2|Outcome|Control Group|Control group (serving as a comparison group)
343955|NCT01134783|O1|Outcome|Intervention Group|"The CHOICES intervention included a 1-credit, academic college course focusing on healthy weight behaviors and participation in a social networking and social support website~CHOICES Intervention: Academic course on healthy weight behaviors followed by participation in a social networking and social support website."
343956|NCT01134783|O2|Outcome|Control Group|Control group (serving as a comparison group)
343957|NCT01134783|O1|Outcome|Intervention Group|"The CHOICES intervention included a 1-credit, academic college course focusing on healthy weight behaviors and participation in a social networking and social support website~CHOICES Intervention: Academic course on healthy weight behaviors followed by participation in a social networking and social support website."
343958|NCT01134783|O2|Outcome|Control Group|Control group (serving as a comparison group)
343959|NCT01134783|O1|Outcome|Intervention Group|"The CHOICES intervention included a 1-credit, academic college course focusing on healthy weight behaviors and participation in a social networking and social support website~CHOICES Intervention: Academic course on healthy weight behaviors followed by participation in a social networking and social support website."
343960|NCT01134783|O2|Outcome|Control Group|This control group arm consists of students who served as the comparison group.
343961|NCT01134783|O1|Outcome|Intervention Group|This intervention arm is a combination of the face-to-face class students, hybrid class students and online class students
343962|NCT01134783|O2|Outcome|Intervention Group|This intervention arm is a combination of the face-to-face class students, hybrid class students and online class students
343963|NCT01134783|O1|Outcome|Control Group|This control group arm consists of students who served as the comparison group.
343964|NCT01134783|E2|Reported Event|Control Group|This control group consists of students who served as the comparison group.
343965|NCT01134783|E1|Reported Event|Intervention Group|This intervention group is a combination of the face-to-face class students, hybrid class students and online class students.
343966|NCT01134731|B4|Baseline|Total|Total of all reporting groups
343967|NCT01134731|B3|Baseline|Placebo 1-5 Capsules|12 weeks
343968|NCT01134731|B2|Baseline|Lithium 600-1500mg|daily
343969|NCT01134731|B1|Baseline|Paliperidone 1-5mg|daily
343970|NCT01134731|P3|Participant Flow|Placebo|1-5 capsules
343971|NCT01134731|P2|Participant Flow|Lithium|"mood stabilizer~dose escalation levels 1-5 daily dosing lithium: 300-1500mg daily (QD)"
343972|NCT01134731|P1|Participant Flow|Paliperidone|dose escalation, levels 1-5 daily dosing range from 1-5 mg
343973|NCT01134731|O3|Outcome|Placebo|1-5 placebo capsules
343974|NCT01134731|O2|Outcome|Lithium|"dose escalation, level 1-5 daily dosing 300-1500mg~lithium: 300-1500mg QD"
343975|NCT01134731|O1|Outcome|Paliperidone|"dose escalation , levels 1-5 daily dosing ranged from 1-5mg~paliperidone: 1-5 mg qd"
343976|NCT01134731|O3|Outcome|Placebo|placebo comparator, 1-5 capsules
344222|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
343977|NCT01134731|O2|Outcome|Lithium|"dose escalation, level 1-5 daily dosing 300-1500mg~lithium: 300-1500mg QD"
343978|NCT01134731|O1|Outcome|Paliperidone|"dose escalation , levels 1-5 daily dosing ranged from 1-5mg~paliperidone: 1-5 mg qd"
343979|NCT01134731|E3|Reported Event|Placebo|
343980|NCT01134731|E2|Reported Event|Lithium|
343981|NCT01134731|E1|Reported Event|Paliperidone|
343982|NCT01134705|B3|Baseline|Total|Total of all reporting groups
343983|NCT01134705|B2|Baseline|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
343984|NCT01134705|B1|Baseline|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
343985|NCT01134705|P2|Participant Flow|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
343986|NCT01134705|P1|Participant Flow|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 micrograms (µg) beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily.
343987|NCT01134705|O2|Outcome|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
343988|NCT01134705|O1|Outcome|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
343989|NCT01134705|O2|Outcome|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
343990|NCT01134705|O1|Outcome|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
343991|NCT01134705|O2|Outcome|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
343992|NCT01134705|O1|Outcome|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
343993|NCT01134705|E2|Reported Event|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
343994|NCT01134705|E1|Reported Event|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
343995|NCT01134627|B3|Baseline|Total|Total of all reporting groups
343996|NCT01134627|B2|Baseline|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
343997|NCT01134627|B1|Baseline|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
343998|NCT01134627|P2|Participant Flow|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
343999|NCT01134627|P1|Participant Flow|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
344000|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
344001|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
344002|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
344003|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
344004|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
344005|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
344006|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
344007|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
344008|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
344009|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
344010|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
344055|NCT01134562|O5|Outcome|Etelcalcetide 60 mg|Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
344223|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
344011|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
344012|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
344013|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
344014|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
344015|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
344016|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
344017|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
344018|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
344019|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
344020|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
344021|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
344022|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
344023|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
344024|NCT01134627|E2|Reported Event|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
344025|NCT01134627|E1|Reported Event|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
344026|NCT01134614|B3|Baseline|Total|Total of all reporting groups
344027|NCT01134614|B2|Baseline|Arm B (Ipilimumab)|"ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.~ipilimumab: Given IV"
344028|NCT01134614|B1|Baseline|Arm A (Ipilimumab and Sargramostim)|"ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.~ipilimumab: Given IV~sargramostim: Given SC"
344029|NCT01134614|P2|Participant Flow|Arm B (Ipilimumab)|"ARM B: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, anti-tumor response is assessed and patients then receive maintenance therapy of ipilimumab IV over 90 minutes on day 1. Treatment with ipilimumab repeats every 12 weeks. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.~ipilimumab: Given IV"
344030|NCT01134614|P1|Participant Flow|Arm A (Ipilimumab and Sargramostim)|"ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, anti-tumor response is assessed and patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.~ipilimumab: Given IV~sargramostim: Given SC"
344031|NCT01134614|O2|Outcome|Arm B (Ipilimumab)|"ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.~ipilimumab: Given IV"
344032|NCT01134614|O1|Outcome|Arm A (Ipilimumab and Sargramostim)|"ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.~ipilimumab: Given IV~sargramostim: Given SC"
344033|NCT01134614|O2|Outcome|Arm B (Ipilimumab)|"ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.~ipilimumab: Given IV"
344034|NCT01134614|O1|Outcome|Arm A (Ipilimumab and Sargramostim)|"ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.~ipilimumab: Given IV~sargramostim: Given SC"
344035|NCT01134614|O2|Outcome|Arm B (Ipilimumab)|"ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.~ipilimumab: Given IV"
344036|NCT01134614|O1|Outcome|Arm A (Ipilimumab and Sargramostim)|"ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.~ipilimumab: Given IV~sargramostim: Given SC"
344037|NCT01134614|E2|Reported Event|Arm B (Ipilimumab)|ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
344038|NCT01134614|E1|Reported Event|Arm A (Ipilimumab and Sargramostim)|ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.
344039|NCT01134562|B6|Baseline|Total|Total of all reporting groups
344040|NCT01134562|B5|Baseline|Cohort 5: Placebo/Etelcalcetide 60 mg|Participants in Cohort 5 received a single dose of 60 mg etelcalcetide or placebo in a parallel group design.
344041|NCT01134562|B4|Baseline|Cohort 4: Placebo/Etelcalcetide 40 mg|Participants in Cohort 4 received a single dose of 40 mg etelcalcetide or placebo in a parallel group design.
344042|NCT01134562|B3|Baseline|Cohort 3: Placebo/Etelcalcetide 20 mg|Participants in Cohort 3 received single doses of 20 mg etelcalcetide and placebo in a crossover design, 7-14 days apart
344043|NCT01134562|B2|Baseline|Cohort 2: Placebo/Etelcalcetide 10 mg|Participants in Cohort 2 received single doses of 10 mg etelcalcetide and placebo in a crossover design, 7-14 days apart
344044|NCT01134562|B1|Baseline|Cohort 1: Placebo/Etelcalcetide 5 mg|Participants in Cohort 1 received single doses of 5 mg etelcalcetide and placebo in a crossover design, 7-14 days apart
344045|NCT01134562|P5|Participant Flow|Cohort 5: Placebo/Etelcalcetide 60 mg|Participants in Cohort 5 received a single dose of 60 mg etelcalcetide or placebo in a parallel group design.
344046|NCT01134562|P4|Participant Flow|Cohort 4: Placebo/Etelcalcetide 40 mg|Participants in Cohort 4 received a single dose of 40 mg etelcalcetide or placebo in a parallel group design.
344047|NCT01134562|P3|Participant Flow|Cohort 3: Placebo/Etelcalcetide 20 mg|Participants in Cohort 3 received single doses of 20 mg etelcalcetide and placebo in a crossover design, 7-14 days apart
344048|NCT01134562|P2|Participant Flow|Cohort 2: Placebo/Etelcalcetide 10 mg|Participants in Cohort 2 received single doses of 10 mg etelcalcetide and placebo in a crossover design, 7-14 days apart
344049|NCT01134562|P1|Participant Flow|Cohort 1: Placebo/Etelcalcetide 5 mg|Participants in Cohort 1 received single doses of 5 mg etelcalcetide and placebo in a crossover design, 7-14 days apart
344050|NCT01134562|O5|Outcome|Etelcalcetide 60 mg|Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
344051|NCT01134562|O4|Outcome|Etelcalcetide 40 mg|Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
344052|NCT01134562|O3|Outcome|Etelcalcetide 20 mg|Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
344053|NCT01134562|O2|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
344054|NCT01134562|O1|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
344056|NCT01134562|O4|Outcome|Etelcalcetide 40 mg|Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
344057|NCT01134562|O3|Outcome|Etelcalcetide 20 mg|Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
344058|NCT01134562|O2|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
344059|NCT01134562|O1|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
344060|NCT01134562|O5|Outcome|Etelcalcetide 60 mg|Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
344061|NCT01134562|O4|Outcome|Etelcalcetide 40 mg|Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
344062|NCT01134562|O3|Outcome|Etelcalcetide 20 mg|Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
344063|NCT01134562|O2|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
344064|NCT01134562|O1|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
344065|NCT01134562|O5|Outcome|Etelcalcetide 60 mg|Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
344066|NCT01134562|O4|Outcome|Etelcalcetide 40 mg|Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
344067|NCT01134562|O3|Outcome|Etelcalcetide 20 mg|Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
344068|NCT01134562|O2|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
344069|NCT01134562|O1|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
344070|NCT01134562|O6|Outcome|Etelcalcetide 60 mg|Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
344071|NCT01134562|O5|Outcome|Etelcalcetide 40 mg|Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
344072|NCT01134562|O4|Outcome|Etelcalcetide 20 mg|Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
344073|NCT01134562|O3|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
344074|NCT01134562|O2|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
344075|NCT01134562|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo IV injection after hemodialysis.
344076|NCT01134562|O6|Outcome|Etelcalcetide 60 mg|Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
344077|NCT01134562|O5|Outcome|Etelcalcetide 40 mg|Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
344078|NCT01134562|O4|Outcome|Etelcalcetide 20 mg|Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
344079|NCT01134562|O3|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
344080|NCT01134562|O2|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
344081|NCT01134562|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo IV injection after hemodialysis.
344082|NCT01134562|O6|Outcome|Etelcalcetide 60 mg|Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
344083|NCT01134562|O5|Outcome|Etelcalcetide 40 mg|Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
344084|NCT01134562|O4|Outcome|Etelcalcetide 20 mg|Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
344085|NCT01134562|O3|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
344086|NCT01134562|O2|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
344087|NCT01134562|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo IV injection after hemodialysis.
344088|NCT01134562|O6|Outcome|Etelcalcetide 60 mg|Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
344089|NCT01134562|O5|Outcome|Etelcalcetide 40 mg|Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
344090|NCT01134562|O4|Outcome|Etelcalcetide 20 mg|Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
344091|NCT01134562|O3|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
344092|NCT01134562|O2|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
344093|NCT01134562|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo IV injection after hemodialysis.
344094|NCT01134562|O6|Outcome|Etelcalcetide 60 mg|Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
344095|NCT01134562|O5|Outcome|Etelcalcetide 40 mg|Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
344096|NCT01134562|O4|Outcome|Etelcalcetide 20 mg|Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
344097|NCT01134562|O3|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
344098|NCT01134562|O2|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
344099|NCT01134562|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo IV injection after hemodialysis.
344100|NCT01134562|O6|Outcome|Etelcalcetide 60 mg|Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
344101|NCT01134562|O5|Outcome|Etelcalcetide 40 mg|Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
344102|NCT01134562|O4|Outcome|Etelcalcetide 20 mg|Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
344220|NCT01134393|B1|Baseline|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
344103|NCT01134562|O3|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
344104|NCT01134562|O2|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
344105|NCT01134562|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo intravenous (IV) injection after hemodialysis.
344106|NCT01134562|E6|Reported Event|Etelcalcetide 60 mg|Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
344107|NCT01134562|E5|Reported Event|Etelcalcetide 40 mg|Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
344108|NCT01134562|E4|Reported Event|Etelcalcetide 20 mg|Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
344109|NCT01134562|E3|Reported Event|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
344110|NCT01134562|E2|Reported Event|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
344111|NCT01134562|E1|Reported Event|Pooled Placebo|Participants received a single dose of placebo intravenous (IV) injection after hemodialysis.
344112|NCT01134549|B6|Baseline|Total|Total of all reporting groups
344113|NCT01134549|B5|Baseline|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
344114|NCT01134549|B4|Baseline|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
344115|NCT01134549|B3|Baseline|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
344116|NCT01134549|B2|Baseline|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
344117|NCT01134549|B1|Baseline|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
344118|NCT01134549|P5|Participant Flow|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
344119|NCT01134549|P4|Participant Flow|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
344120|NCT01134549|P3|Participant Flow|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
344121|NCT01134549|P2|Participant Flow|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
344122|NCT01134549|P1|Participant Flow|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
344123|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
344124|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
344125|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
344126|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
344127|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
344128|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
344129|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
344130|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
344131|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
344132|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
344133|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
344134|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
344135|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
344136|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
344137|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
344138|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
344139|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
344140|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
344141|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
344142|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
344143|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
344144|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
344145|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
344146|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
344147|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
344148|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
344221|NCT01134393|P1|Participant Flow|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
344149|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
344150|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
344151|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
344152|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
344153|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
344154|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
344155|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
344156|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
344157|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
344158|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
344159|NCT01134549|O5|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
344160|NCT01134549|O4|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
344161|NCT01134549|O3|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
344162|NCT01134549|O2|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
344163|NCT01134549|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
344164|NCT01134549|O5|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
344165|NCT01134549|O4|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
344166|NCT01134549|O3|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
344167|NCT01134549|O2|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
344168|NCT01134549|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
344169|NCT01134549|O5|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
344170|NCT01134549|O4|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
344171|NCT01134549|O3|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
344172|NCT01134549|O2|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
344173|NCT01134549|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
344174|NCT01134549|O5|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
344175|NCT01134549|O4|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
344176|NCT01134549|O3|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
344177|NCT01134549|O2|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
344178|NCT01134549|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
344179|NCT01134549|O5|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
344180|NCT01134549|O4|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
344181|NCT01134549|O3|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
344182|NCT01134549|O2|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
344183|NCT01134549|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
344184|NCT01134549|O5|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
344185|NCT01134549|O4|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
344186|NCT01134549|O3|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
344187|NCT01134549|O2|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
344188|NCT01134549|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
344189|NCT01134549|O5|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
344190|NCT01134549|O4|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
344191|NCT01134549|O3|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
344192|NCT01134549|O2|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
344193|NCT01134549|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
344194|NCT01134549|O5|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
344195|NCT01134549|O4|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
344196|NCT01134549|O3|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
344197|NCT01134549|O2|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
344198|NCT01134549|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
344199|NCT01134549|E6|Reported Event|Etelcalcetide Pooled|Participants received a single dose of etelcalcetide administered by intravenous injection.
344200|NCT01134549|E5|Reported Event|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
344201|NCT01134549|E4|Reported Event|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
344202|NCT01134549|E3|Reported Event|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
344203|NCT01134549|E2|Reported Event|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
344204|NCT01134549|E1|Reported Event|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
344205|NCT01134510|B3|Baseline|Total|Total of all reporting groups
344206|NCT01134510|B2|Baseline|Placebo|Potential subjects will be identified after a review of medical records of patients under the care of one or more of the study investigators. Potential subjects will be identified and approached during an inpatient or outpatient clinical visit by a member of the research team. The Principal investigator (PI) I will explain what it means to be highly-sensitized and the risks associated with it. Then PI will describe the standard of care of Transplant Immunology Program (TIP) patients. After that PI will describe the study and explain the risks and benefits of participation. After the discussion, a copy of the consent form will be either emailed or faxed to the patient for review and consideration of study participation. The patient can contact the study team where they will have the opportunity to ask questions and then sign the Informed Consent Form (ICF), if interested.
344207|NCT01134510|B1|Baseline|C1 Esterase Inhibitor|"Potential subjects will be identified after a review of medical records of patients under the care of one or more of the study investigators. Potential subjects will be identified and approached during an inpatient or outpatient clinical visit by a member of the research team. The Principal investigator (PI) I will explain what it means to be highly-sensitized and the risks associated with it. The PI will describe the study and explain the risks and benefits of participation. After the discussion, a copy of the consent form will be emailed or faxed to the patient for review & consideration of study participation. The patient can contact the study team to ask questions and sign the Informed Consent Form (ICF), if interested.~C1 INH is dosed at 20 units per kg body weight and is administered by slow IV injection at a rate of approximately 4 mL per minute. Study patients will receive 20U/kg C1 INH vs placebo (0.9% NS) on days 0 and day 2, then twice weekly X 3 weeks."
344208|NCT01134510|P2|Participant Flow|Placebo|Patients will receive placebo (0.9% Normal Saline) on days 0 and day 2, then twice weekly for 3 weeks.
344209|NCT01134510|P1|Participant Flow|C1 Esterase Inhibitor|Patients receiving transplants will have pre-transplant labs for C1 INH levels, Complement 3 and Complement 4 obtained. In addition to the standard post-transplant immunosuppressive protocol, participating patients will receive 20 Units/kg C1 INH vs placebo (0.9% Normal Saline) on day 0 and day 2, then twice weekly X 3 weeks. A protocol biopsy will be performed at 6 month to assess the allograft for evidence of Antibody Mediated Rejection, including C4d staining using Banff 2009 criteria. After completion of the C1 INH therapy, patients will be followed up to 6M to assess allograft function and Anibody Mediated Rejection episodes as well as Donor Specific Antibody. A protocol biopsy will be performed at 6 month.
344210|NCT01134510|O2|Outcome|Placebo|Patients will receive placebo (0.9% NS) on days 0 and day 2, then twice weekly X3 weeks.
344211|NCT01134510|O1|Outcome|C1 Esterase Inhibitor|Patients receiving transplants will have pre-transplant labs for C1 INH levels, C3 and C4 obtained. In addition to the standard post-transplant immunosuppressive protocol, participating patients will receive 20 Units/kg C1 INH vs placebo (0.9% NS) on day 0 and day 2, then twice weekly X 3 weeks (see Appendix A). A protocol biopsy will be performed at 6M to assess the allograft for evidence of AMR, including C4d staining using Banff 2009 criteria. After completion of the C1 INH therapy, patients will be followed up to 6M to assess allograft function and AMR episodes as well as DSA. A protocol biopsy will be performed at 6M.
344212|NCT01134510|O2|Outcome|Placebo|Patients will receive placebo (0.9% NS) on days 0 and day 2, then twice weekly X3 weeks.
344213|NCT01134510|O1|Outcome|C1 Esterase Inhibitor|Patients receiving transplants will have pre-transplant labs for C1 INH levels, C3 and C4 obtained. In addition to the standard post-transplant immunosuppressive protocol, participating patients will receive 20 units/kg C1 INH vs placebo (0.9% NS) on day 0 and day 2, then twice weekly X 3 weeks (see Appendix A). A protocol biopsy will be performed at 6M to assess the allograft for evidence of AMR, including C4d staining using Banff 2009 criteria. After completion of the C1 INH therapy, patients will be followed up to 6M to assess allograft function and AMR episodes as well as DSA. A protocol biopsy will be performed at 6M.
344214|NCT01134510|O2|Outcome|Placebo|Patients will receive placebo (0.9% NS) on days 0 and day 2, then twice weekly X3 weeks.
344215|NCT01134510|O1|Outcome|C1 Esterase Inhibitor|Patients receiving transplants will have pre-transplant labs for C1 INH levels, C3 and C4 obtained. In addition to the standard post-transplant immunosuppressive protocol, participating patients will receive 20 units/kg C1 INH vs placebo (0.9% NS) on day 0 and day 2, then twice weekly X 3 weeks (see Appendix A). A protocol biopsy will be performed at 6M to assess the allograft for evidence of AMR, including C4d staining using Banff 2009 criteria. After completion of the C1 INH therapy, patients will be followed up to 6M to assess allograft function and AMR episodes as well as DSA. A protocol biopsy will be performed at 6M.
344216|NCT01134510|O2|Outcome|Normal Saline|"10 subjects placebo in addition to standard of care immunosuppressive therapy.~C1 Esterase Inhibitor: C1 Esterase Inhibitor 20 units/kg vs Placebo twice weekly x 4 weeks"
344217|NCT01134510|O1|Outcome|C1 Esterase Inhibitor|"10 subjects will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.~C1 Esterase Inhibitor: C1 Esterase Inhibitor 20 units/kg vs Placebo twice weekly x 4 weeks"
344218|NCT01134510|E2|Reported Event|C1 Esterase Inhibitor|Total of 1 Serious Adverse Event (1/10 = 10%)
344219|NCT01134510|E1|Reported Event|Placebo|Total of 2 Serious Adverse Events (2/10 patients = 20%)
344224|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
344225|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
344226|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
344227|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
344228|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
344229|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
344230|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
344231|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
344232|NCT01134393|E2|Reported Event|T80/A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily
344233|NCT01134393|E1|Reported Event|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
344234|NCT01134328|B5|Baseline|Total|Total of all reporting groups
344235|NCT01134328|B4|Baseline|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
344236|NCT01134328|B3|Baseline|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
344237|NCT01134328|B2|Baseline|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
344238|NCT01134328|B1|Baseline|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
344239|NCT01134328|P4|Participant Flow|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
344240|NCT01134328|P3|Participant Flow|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
344241|NCT01134328|P2|Participant Flow|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
344242|NCT01134328|P1|Participant Flow|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
344243|NCT01134328|O4|Outcome|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
344244|NCT01134328|O3|Outcome|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
344245|NCT01134328|O2|Outcome|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
344246|NCT01134328|O1|Outcome|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
344247|NCT01134328|O4|Outcome|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
344248|NCT01134328|O3|Outcome|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
344249|NCT01134328|O2|Outcome|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
344250|NCT01134328|O1|Outcome|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
344251|NCT01134328|O4|Outcome|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
344252|NCT01134328|O3|Outcome|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
344253|NCT01134328|O2|Outcome|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
344254|NCT01134328|O1|Outcome|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
344255|NCT01134328|O4|Outcome|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
344256|NCT01134328|O3|Outcome|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
344257|NCT01134328|O2|Outcome|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
344258|NCT01134328|O1|Outcome|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
344259|NCT01134328|O4|Outcome|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
344260|NCT01134328|O3|Outcome|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
344261|NCT01134328|O2|Outcome|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
344262|NCT01134328|O1|Outcome|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
344263|NCT01134328|O4|Outcome|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
344264|NCT01134328|O3|Outcome|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
344265|NCT01134328|O2|Outcome|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
344266|NCT01134328|O1|Outcome|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
344267|NCT01134328|O4|Outcome|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
344268|NCT01134328|O3|Outcome|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
344269|NCT01134328|O2|Outcome|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
344270|NCT01134328|O1|Outcome|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
344271|NCT01134328|O4|Outcome|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
344272|NCT01134328|O3|Outcome|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
344273|NCT01134328|O2|Outcome|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
344274|NCT01134328|O1|Outcome|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
344275|NCT01134328|O4|Outcome|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
344276|NCT01134328|O3|Outcome|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
344277|NCT01134328|O2|Outcome|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
344278|NCT01134328|O1|Outcome|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
344279|NCT01134328|O4|Outcome|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
344280|NCT01134328|O3|Outcome|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
344281|NCT01134328|O2|Outcome|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
344282|NCT01134328|O1|Outcome|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
344283|NCT01134328|O4|Outcome|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
344284|NCT01134328|O3|Outcome|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
344285|NCT01134328|O2|Outcome|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
344286|NCT01134328|O1|Outcome|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
344287|NCT01134328|O4|Outcome|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
344288|NCT01134328|O3|Outcome|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
344289|NCT01134328|O2|Outcome|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
344290|NCT01134328|O1|Outcome|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
344291|NCT01134328|O4|Outcome|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
344292|NCT01134328|O3|Outcome|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
344293|NCT01134328|O2|Outcome|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
344294|NCT01134328|O1|Outcome|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
344295|NCT01134328|O4|Outcome|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
344296|NCT01134328|O3|Outcome|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
344297|NCT01134328|O2|Outcome|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
344298|NCT01134328|O1|Outcome|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
344299|NCT01134328|O4|Outcome|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
344300|NCT01134328|O3|Outcome|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
344301|NCT01134328|O2|Outcome|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
344302|NCT01134328|O1|Outcome|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
344303|NCT01134328|O4|Outcome|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
344304|NCT01134328|O3|Outcome|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
344305|NCT01134328|O2|Outcome|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
344306|NCT01134328|O1|Outcome|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
344307|NCT01134328|O4|Outcome|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
344308|NCT01134328|O3|Outcome|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
344309|NCT01134328|O2|Outcome|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
344310|NCT01134328|O1|Outcome|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
344311|NCT01134328|O4|Outcome|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
344312|NCT01134328|O3|Outcome|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
344313|NCT01134328|O2|Outcome|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
344314|NCT01134328|O1|Outcome|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
344315|NCT01134328|O4|Outcome|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
344316|NCT01134328|O3|Outcome|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
344317|NCT01134328|O2|Outcome|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
344318|NCT01134328|O1|Outcome|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
344319|NCT01134328|O4|Outcome|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
344320|NCT01134328|O3|Outcome|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
344321|NCT01134328|O2|Outcome|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
344322|NCT01134328|O1|Outcome|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
344323|NCT01134328|O4|Outcome|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
344324|NCT01134328|O3|Outcome|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
344325|NCT01134328|O2|Outcome|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
344326|NCT01134328|O1|Outcome|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
344327|NCT01134328|O4|Outcome|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
344328|NCT01134328|O3|Outcome|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
344329|NCT01134328|O2|Outcome|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
344330|NCT01134328|O1|Outcome|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
344331|NCT01134328|O4|Outcome|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
344332|NCT01134328|O3|Outcome|AC-150B 0.005%|AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
344333|NCT01134328|O2|Outcome|AC-150A 0.1%|AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
344334|NCT01134328|O1|Outcome|AC-150 Combo|AC-150 Combo: 1 drop in each eye for up to 14 days
344335|NCT01134328|E4|Reported Event|Vehicle|Vehicle: 1 drop in each eye once per day for up to 14 days
344336|NCT01134328|E3|Reported Event|AC-150B 0.005%|AC-150B: 1 drop in each eye once per day for up to 14 days
344337|NCT01134328|E2|Reported Event|AC-150A 0.1%|AC-150A: 1 drop in each eye once per day for up to 14 days
344338|NCT01134328|E1|Reported Event|AC-150 Combo|AC-150: 1 drop in each eye for up to 14 days
344339|NCT01134315|B3|Baseline|Total|Total of all reporting groups
344340|NCT01134315|B2|Baseline|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
344341|NCT01134315|B1|Baseline|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
344342|NCT01134315|P2|Participant Flow|Calcitriol|Pediatric participants who received calcitriol to treat secondary hyperparathyroidism (SHPT). Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
344343|NCT01134315|P1|Participant Flow|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat secondary hyperparathyroidism (SHPT). Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
344344|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
344345|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
344346|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
344347|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
344348|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
344349|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
344350|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
344351|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
344352|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
344353|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
344354|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
344355|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
344356|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
344357|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
344358|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
344359|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
344360|NCT01134315|E2|Reported Event|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
344361|NCT01134315|E1|Reported Event|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
344362|NCT01134276|B3|Baseline|Total|Total of all reporting groups
344363|NCT01134276|B2|Baseline|PTBD|final biliary drainage procedure : biliary drainage via PTBD
344364|NCT01134276|B1|Baseline|ERBD|final biliary drainage procedure: biliary drainage via ERBD/ENBD
344365|NCT01134276|P2|Participant Flow|PTBD|biliary drainage : biliary drainage via PTBD
344366|NCT01134276|P1|Participant Flow|ERBD|biliary drainage : biliary drainage via ERBD/ENBD
344367|NCT01134276|O2|Outcome|ERBD|Final biliary drainage procedure: biliary drainage via ERBD/ENBD
344368|NCT01134276|O1|Outcome|PTBD|Final biliary drainage procedure: biliary drainage via PTBD
344369|NCT01134276|O2|Outcome|ENBD/ERBD|Final biliary drainage procedure: biliary drainage via ENBD/ERBD
344370|NCT01134276|O1|Outcome|PTBD|Final biliary drainage procedure: biliary drainage via PTBD
344371|NCT01134276|O2|Outcome|ERBD|finial biliary drainage procedure: biliary drainage via ERBD or ENBD
344372|NCT01134276|O1|Outcome|PTBD|finial biliary drainage procedure: biliary drainage via PTBD
344373|NCT01134276|E2|Reported Event|ERBD|"final biliary drainage procedure: biliary drainage via ERBD/ENBD~Adverse event will be monitored by examination of clinic doctor in both in-patient and out-patient setting"
344374|NCT01134276|E1|Reported Event|PTBD|"final biliary drainage procedure: biliary drainage via PTBD~Adverse event will be monitored by examination of clinic doctor in both in-patient and out-patient setting"
344375|NCT01134107|B3|Baseline|Total|Total of all reporting groups
344376|NCT01134107|B2|Baseline|Aspart 6D/Lispro 6D|Insulin Aspart 6D administered by infusion pump for 12 weeks, followed by Insulin Lispro 6D administered by infusion pump for 12 weeks.
344377|NCT01134107|B1|Baseline|Lispro 6D/Aspart 6D|Insulin Lispro 6D administered by infusion pump for 12 weeks, followed by Insulin Aspart 6D administered by infusion pump for 12 weeks.
344378|NCT01134107|P2|Participant Flow|Aspart 6D/Lispro 6D|Insulin Aspart 6D administered by infusion pump for 12 weeks, followed by Insulin Lispro 6D administered by infusion pump for 12 weeks.
344379|NCT01134107|P1|Participant Flow|Lispro 6D/Aspart 6D|Insulin Lispro 6 Day (6D) administered by infusion pump for 12 weeks, followed by Insulin Aspart 6D administered by infusion pump for 12 weeks.
344380|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
344381|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
344382|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
344383|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
344384|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
344385|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
344386|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
344387|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
344388|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
344389|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
344390|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
344391|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
344392|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
344393|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
344394|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
344395|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
344396|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
344397|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
344398|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
344399|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
344400|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
344401|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
344402|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
344403|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
344404|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
344405|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
344406|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
344407|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
344408|NCT01134107|E2|Reported Event|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
344409|NCT01134107|E1|Reported Event|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
344410|NCT01134081|B1|Baseline|CelTx™ & Free Gingival Grafts|CelTx™: Living bilayered cell therapy product Free Gingival Grafts: Harvested tissue from palate
344411|NCT01134081|P1|Participant Flow|CelTx™ & Free Gingival Grafts|CelTx™: Living bilayered cell therapy product Free Gingival Grafts: Harvested tissue from palate
344412|NCT01134081|O2|Outcome|Free Gingival Grafts|"Harvested tissue from palate~Free Gingival Graft: Harvested tissue from palate"
344413|NCT01134081|O1|Outcome|CelTx™|"Living bilayered cell therapy product~CelTx™: CelTx™ is a living bilayered cell therapy product. CelTx™ is constructed of Type I bovine collagen (extracted from bovine tendons and subsequently purified) and viable allogeneic human fibroblasts and keratinocytes isolated from human neonatal foreskin. This is applied once in the oral cavity."
344414|NCT01134081|O2|Outcome|Free Gingival Grafts|Harvested tissue from palate
344415|NCT01134081|O1|Outcome|CelTx™|Living bilayered cell therapy product
344416|NCT01134081|E2|Reported Event|Free Gingival Graft|Harvested tissue from palate
344417|NCT01134081|E1|Reported Event|CelTx™|Living bilayered cell therapy product
344418|NCT01134055|B8|Baseline|Total|Total of all reporting groups
344419|NCT01134055|B7|Baseline|Ranibizumab Injections Active Open-label Control Arm|Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
344420|NCT01134055|B6|Baseline|Pazopanib Eye Drops 10 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344421|NCT01134055|B5|Baseline|Pazopanib Eye Drops 10 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344422|NCT01134055|B4|Baseline|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344445|NCT01134055|O7|Outcome|Ranibizumab Injections Active Open-label Control Arm|Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
352897|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
344423|NCT01134055|B3|Baseline|Pazopanib Eye Drops 5 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344424|NCT01134055|B2|Baseline|Pazopanib Eye Drops 5 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344425|NCT01134055|B1|Baseline|Placebo Control Arm QID|Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344426|NCT01134055|P7|Participant Flow|Ranibizumab Injections Active Open-label Control Arm|Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
344427|NCT01134055|P6|Participant Flow|Pazopanib Eye Drops 10 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344428|NCT01134055|P5|Participant Flow|Pazopanib Eye Drops 10 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344429|NCT01134055|P4|Participant Flow|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344430|NCT01134055|P3|Participant Flow|Pazopanib Eye Drops 5 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344431|NCT01134055|P2|Participant Flow|Pazopanib Eye Drops 5 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 milligram/milliliter (mg/mL) TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344432|NCT01134055|P1|Participant Flow|Placebo Control Arm QID|Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344433|NCT01134055|O5|Outcome|Pazopanib Eye Drops 10 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344936|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
344434|NCT01134055|O4|Outcome|Pazopanib Eye Drops 10 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344435|NCT01134055|O3|Outcome|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344436|NCT01134055|O2|Outcome|Pazopanib Eye Drops 5 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344437|NCT01134055|O1|Outcome|Pazopanib Eye Drops 5 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344438|NCT01134055|O7|Outcome|Ranibizumab Injections Active Open-label Control Arm|Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
344439|NCT01134055|O6|Outcome|Pazopanib Eye Drops 10 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344440|NCT01134055|O5|Outcome|Pazopanib Eye Drops 10 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344441|NCT01134055|O4|Outcome|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344442|NCT01134055|O3|Outcome|Pazopanib Eye Drops 5 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344443|NCT01134055|O2|Outcome|Pazopanib Eye Drops 5 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344444|NCT01134055|O1|Outcome|Placebo Control Arm QID|Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344810|NCT01133522|B10|Baseline|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
344446|NCT01134055|O6|Outcome|Pazopanib Eye Drops 10 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344447|NCT01134055|O5|Outcome|Pazopanib Eye Drops 10 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344448|NCT01134055|O4|Outcome|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344449|NCT01134055|O3|Outcome|Pazopanib Eye Drops 5 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344450|NCT01134055|O2|Outcome|Pazopanib Eye Drops 5 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344451|NCT01134055|O1|Outcome|Placebo Control Arm QID|Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344452|NCT01134055|O7|Outcome|Ranibizumab Injections Active Open-label Control Arm|Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
344453|NCT01134055|O6|Outcome|Pazopanib Eye Drops 10 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344454|NCT01134055|O5|Outcome|Pazopanib Eye Drops 10 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344455|NCT01134055|O4|Outcome|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344456|NCT01134055|O3|Outcome|Pazopanib Eye Drops 5 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344811|NCT01133522|B9|Baseline|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
344457|NCT01134055|O2|Outcome|Pazopanib Eye Drops 5 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344458|NCT01134055|O1|Outcome|Placebo Control Arm QID|Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344459|NCT01134055|O7|Outcome|Ranibizumab Injections Active Open-label Control Arm|Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
344460|NCT01134055|O6|Outcome|Pazopanib Eye Drops 10 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344461|NCT01134055|O5|Outcome|Pazopanib Eye Drops 10 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344462|NCT01134055|O4|Outcome|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344463|NCT01134055|O3|Outcome|Pazopanib Eye Drops 5 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344464|NCT01134055|O2|Outcome|Pazopanib Eye Drops 5 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344465|NCT01134055|O1|Outcome|Placebo Control Arm QID|Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344466|NCT01134055|O7|Outcome|Ranibizumab Injections Active Open-label Control Arm|Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
344467|NCT01134055|O6|Outcome|Pazopanib Eye Drops 10 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344501|NCT01134055|O7|Outcome|Ranibizumab Injections Active Open-label Control Arm|Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
344577|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344468|NCT01134055|O5|Outcome|Pazopanib Eye Drops 10 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344469|NCT01134055|O4|Outcome|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344470|NCT01134055|O3|Outcome|Pazopanib Eye Drops 5 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344471|NCT01134055|O2|Outcome|Pazopanib Eye Drops 5 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344472|NCT01134055|O1|Outcome|Placebo Control Arm QID|Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344473|NCT01134055|O7|Outcome|Ranibizumab Injections Active Open-label Control Arm|Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
344474|NCT01134055|O6|Outcome|Pazopanib Eye Drops 10 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344475|NCT01134055|O5|Outcome|Pazopanib Eye Drops 10 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344476|NCT01134055|O4|Outcome|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344477|NCT01134055|O3|Outcome|Pazopanib Eye Drops 5 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344478|NCT01134055|O2|Outcome|Pazopanib Eye Drops 5 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344855|NCT01133522|O2|Outcome|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
344479|NCT01134055|O1|Outcome|Placebo Control Arm QID|Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344480|NCT01134055|O7|Outcome|Ranibizumab Injections Active Open-label Control Arm|Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
344481|NCT01134055|O6|Outcome|Pazopanib Eye Drops 10 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344482|NCT01134055|O5|Outcome|Pazopanib Eye Drops 10 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344483|NCT01134055|O4|Outcome|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344484|NCT01134055|O3|Outcome|Pazopanib Eye Drops 5 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344485|NCT01134055|O2|Outcome|Pazopanib Eye Drops 5 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344486|NCT01134055|O1|Outcome|Placebo Control Arm QID|Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344487|NCT01134055|O7|Outcome|Ranibizumab Injections Active Open-label Control Arm|Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
344488|NCT01134055|O6|Outcome|Pazopanib Eye Drops 10 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344489|NCT01134055|O5|Outcome|Pazopanib Eye Drops 10 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344535|NCT01134055|O7|Outcome|Ranibizumab Injections Active Open-label Control Arm|Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
344578|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344490|NCT01134055|O4|Outcome|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344491|NCT01134055|O3|Outcome|Pazopanib Eye Drops 5 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344492|NCT01134055|O2|Outcome|Pazopanib Eye Drops 5 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344493|NCT01134055|O1|Outcome|Placebo Control Arm QID|Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344494|NCT01134055|O7|Outcome|Ranibizumab Injections Active Open-label Control Arm|Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
344495|NCT01134055|O6|Outcome|Pazopanib Eye Drops 10 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344496|NCT01134055|O5|Outcome|Pazopanib Eye Drops 10 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344497|NCT01134055|O4|Outcome|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344498|NCT01134055|O3|Outcome|Pazopanib Eye Drops 5 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344499|NCT01134055|O2|Outcome|Pazopanib Eye Drops 5 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344500|NCT01134055|O1|Outcome|Placebo Control Arm QID|Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344812|NCT01133522|B8|Baseline|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
344502|NCT01134055|O6|Outcome|Pazopanib Eye Drops 10 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344503|NCT01134055|O5|Outcome|Pazopanib Eye Drops 10 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344504|NCT01134055|O4|Outcome|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344505|NCT01134055|O3|Outcome|Pazopanib Eye Drops 5 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344506|NCT01134055|O2|Outcome|Pazopanib Eye Drops 5 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344507|NCT01134055|O1|Outcome|Placebo Control Arm QID|Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344508|NCT01134055|O7|Outcome|Ranibizumab Injections Active Open-label Control Arm|Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
344509|NCT01134055|O6|Outcome|Pazopanib Eye Drops 10 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344510|NCT01134055|O5|Outcome|Pazopanib Eye Drops 10 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344511|NCT01134055|O4|Outcome|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344512|NCT01134055|O3|Outcome|Pazopanib Eye Drops 5 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344813|NCT01133522|B7|Baseline|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
344513|NCT01134055|O2|Outcome|Pazopanib Eye Drops 5 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344514|NCT01134055|O1|Outcome|Placebo Control Arm QID|Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344515|NCT01134055|O6|Outcome|Pazopanib Eye Drops 10 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344516|NCT01134055|O5|Outcome|Pazopanib Eye Drops 10 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344517|NCT01134055|O4|Outcome|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344518|NCT01134055|O3|Outcome|Pazopanib Eye Drops 5 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344519|NCT01134055|O2|Outcome|Pazopanib Eye Drops 5 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344520|NCT01134055|O1|Outcome|Placebo Control Arm QID|Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344521|NCT01134055|O7|Outcome|Ranibizumab Injections Active Open-label Control Arm|Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
344522|NCT01134055|O6|Outcome|Pazopanib Eye Drops 10 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344523|NCT01134055|O5|Outcome|Pazopanib Eye Drops 10 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344814|NCT01133522|B6|Baseline|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
344524|NCT01134055|O4|Outcome|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344525|NCT01134055|O3|Outcome|Pazopanib Eye Drops 5 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344526|NCT01134055|O2|Outcome|Pazopanib Eye Drops 5 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344527|NCT01134055|O1|Outcome|Placebo Control Arm QID|Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344528|NCT01134055|O7|Outcome|Ranibizumab Injections Active Open-label Control Arm|Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
344529|NCT01134055|O6|Outcome|Pazopanib Eye Drops 10 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344530|NCT01134055|O5|Outcome|Pazopanib Eye Drops 10 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344531|NCT01134055|O4|Outcome|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344532|NCT01134055|O3|Outcome|Pazopanib Eye Drops 5 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344533|NCT01134055|O2|Outcome|Pazopanib Eye Drops 5 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344534|NCT01134055|O1|Outcome|Placebo Control Arm QID|Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344815|NCT01133522|B5|Baseline|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
344536|NCT01134055|O6|Outcome|Pazopanib Eye Drops 10 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344537|NCT01134055|O5|Outcome|Pazopanib Eye Drops 10 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344538|NCT01134055|O4|Outcome|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344539|NCT01134055|O3|Outcome|Pazopanib Eye Drops 5 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344540|NCT01134055|O2|Outcome|Pazopanib Eye Drops 5 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344541|NCT01134055|O1|Outcome|Placebo Control Arm QID|Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344542|NCT01134055|O6|Outcome|Pazopanib Eye Drops 10 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344543|NCT01134055|O5|Outcome|Pazopanib Eye Drops 10 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344544|NCT01134055|O4|Outcome|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344545|NCT01134055|O3|Outcome|Pazopanib Eye Drops 5 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344574|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344931|NCT01133379|P2|Participant Flow|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
344546|NCT01134055|O2|Outcome|Pazopanib Eye Drops 5 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344547|NCT01134055|O1|Outcome|Placebo Control Arm QID|Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344548|NCT01134055|O7|Outcome|Ranibizumab Injections Active Open-label Control Arm|Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
344549|NCT01134055|O6|Outcome|Pazopanib Eye Drops 10 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344550|NCT01134055|O5|Outcome|Pazopanib Eye Drops 10 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344551|NCT01134055|O4|Outcome|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344552|NCT01134055|O3|Outcome|Pazopanib Eye Drops 5 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344553|NCT01134055|O2|Outcome|Pazopanib Eye Drops 5 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344554|NCT01134055|O1|Outcome|Placebo Control Arm QID|Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344555|NCT01134055|E7|Reported Event|Ranibizumab Injections Active Open-label Control Arm|Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
344556|NCT01134055|E6|Reported Event|Pazopanib Eye Drops 10 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344575|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344576|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344557|NCT01134055|E5|Reported Event|Pazopanib Eye Drops 10 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344558|NCT01134055|E4|Reported Event|Pazopanib Eye Drops 10 mg/mL BID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344559|NCT01134055|E3|Reported Event|Pazopanib Eye Drops 5 mg/mL QID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344560|NCT01134055|E2|Reported Event|Pazopanib Eye Drops 5 mg/mL TID|Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344561|NCT01134055|E1|Reported Event|Placebo Control Arm QID|Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
344562|NCT01134042|B4|Baseline|Total|Total of all reporting groups
344563|NCT01134042|B3|Baseline|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344564|NCT01134042|B2|Baseline|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344565|NCT01134042|B1|Baseline|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344566|NCT01134042|P3|Participant Flow|FP 500 µg BID|Participants received Fluticasone Propionate (FP) 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344567|NCT01134042|P2|Participant Flow|FF/VI 200/25 µg OD|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344568|NCT01134042|P1|Participant Flow|FF 200 µg OD|Participants received FF 200 microgram (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening plus placebo via the DISKUS/ACCUHALER twice daily (BID), for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344569|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344570|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344571|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344572|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344573|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344816|NCT01133522|B4|Baseline|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
344579|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344580|NCT01134042|O1|Outcome|FF 200 µg OD Arm|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344581|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344582|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344583|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344584|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344585|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344586|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344587|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344588|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344589|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344590|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344591|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344592|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344593|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344594|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344595|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344596|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344597|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344598|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344599|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344600|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344601|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344602|NCT01134042|E3|Reported Event|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344603|NCT01134042|E2|Reported Event|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344604|NCT01134042|E1|Reported Event|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
344605|NCT01134016|B1|Baseline|Antroquinonol|"Safety dose finding from 50mg to 600mg~Antroquinonol : Dosage form: 50 mg and 100 mg capsules~Dosage levels: 50 mg, 100 mg, 200 mg, 300mg, 450mg and 600mg ( 6 cohorts)~Frequency: take daily for 4 weeks per subject per dosage level"
344606|NCT01134016|P1|Participant Flow|Antroquinonol|"Safety dose finding from 50mg to 600mg~Antroquinonol : Dosage form: 50 mg and 100 mg capsules~Dosage levels: 50 mg, 100 mg, 200 mg, 300mg, 450mg and 600mg ( 6 cohorts)~Frequency: take daily for 4 weeks per subject per dosage level"
344607|NCT01134016|O1|Outcome|Tumer Responce at Per-protocol (PP) Population|All patients who completed at least 3 cycles of treatment with proper imaging assessment (RECIST) of tumor size.
344608|NCT01134016|O1|Outcome|AUC0-t on Day 28|truncated area under the plasma concentration-time curve from the beginning of dosing to the last measurable concentration on Day 28
344609|NCT01134016|O1|Outcome|AUC0-t on Day 1|truncated area under the plasma concentration-time curve from the beginning of dosing to the last measurable concentration on Day 1
344610|NCT01134016|O1|Outcome|Cmax Day 28|the observed maximum plasma concentration after dosing on Day 28
344611|NCT01134016|O1|Outcome|Cmax Day 1|the observed maximum plasma concentration after dosing on Day 1
344612|NCT01134016|O12|Outcome|Half-life Time Day 28: 600mg|The time of plasma concentration drops from maximum to half
344613|NCT01134016|O11|Outcome|Half-life Time Day 28: 450 mg|The time of plasma concentration drops from maximum to half
344614|NCT01134016|O10|Outcome|Half-life Time Day 28: 300 mg|The time of plasma concentration drops from maximum to half
344615|NCT01134016|O9|Outcome|Half-life Time Day 28: 200 mg|The time of plasma concentration drops from maximum to half
344616|NCT01134016|O8|Outcome|Half-life Time Day 28:100 mg|The time of plasma concentration drops from maximum to half
344617|NCT01134016|O7|Outcome|Half-life Time Day 28: 50mg|The time of plasma concentration drops from maximum to half
344618|NCT01134016|O6|Outcome|Half-life Time Day 1: 600 mg|The time of plasma concentration drops from maximum to half
344619|NCT01134016|O5|Outcome|Half-life Time Day 1: 450 mg|The time of plasma concentration drops from maximum to half
344620|NCT01134016|O4|Outcome|Half-life Time Day 1: 300mg|The time of plasma concentration drops from maximum to half
344621|NCT01134016|O3|Outcome|Half-life Time Day 1: 200mg|The time of plasma concentration drops from maximum to half
344622|NCT01134016|O2|Outcome|Half-life Time Day 1: 100 mg|The time of plasma concentration drops from maximum to half
344623|NCT01134016|O1|Outcome|Half-life Time Day 1:50mg|The time of plasma concentration drops from maximum to half
344624|NCT01134016|O12|Outcome|Tmax Day 28: 600mg|Patient represent the time to reach the maximum plasma concentration after dose
344625|NCT01134016|O11|Outcome|Tmax Day 28: 450mg|Patient represent the time to reach the maximum plasma concentration after dose
344626|NCT01134016|O10|Outcome|Tmax Day 28: 300mg|Patient represent the time to reach the maximum plasma concentration after dose
344627|NCT01134016|O9|Outcome|Tmax Day 28: 200 mg|Patient represent the time to reach the maximum plasma concentration after dose
344628|NCT01134016|O8|Outcome|Tmax Day 28: 100mg|Patient represent the time to reach the maximum plasma concentration after dose
344629|NCT01134016|O7|Outcome|Tmax Day 28: 50mg|Patient represent the time to reach the maximum plasma concentration after dose
344630|NCT01134016|O6|Outcome|Tmax Day 1 :600 mg|Patient represent the time to reach the maximum plasma concentration after dose
344631|NCT01134016|O5|Outcome|Tmax Day 1: 450mg|Patient represent the time to reach the maximum plasma concentration after dose
344632|NCT01134016|O4|Outcome|Tmax Day 1: 300mg|Patient represent the time to reach the maximum plasma concentration after dose
344633|NCT01134016|O3|Outcome|Tmax Day 1: 200mg|Patient represent the time to reach the maximum plasma concentration after dose
344634|NCT01134016|O2|Outcome|Tmax Day 1: 100 mg|Patient represent the time to reach the maximum plasma concentration after dose
344635|NCT01134016|O1|Outcome|Tmax Day1: 50mg|Patient represent the time to reach the maximum plasma concentration after dose
344636|NCT01134016|O1|Outcome|Antroquinonol|Maximum Tolerable Dose for Antroquinonol
344637|NCT01134016|E1|Reported Event|Antroquinonol|"Safety dose finding from 50mg to 600mg~Antroquinonol : Dosage form: 50 mg and 100 mg capsules~Dosage levels: 50 mg, 100 mg, 200 mg, 300mg, 450mg and 600mg ( 6 cohorts)~Frequency: take daily for 4 weeks per subject per dosage level"
344638|NCT01133977|B6|Baseline|Total|Total of all reporting groups
344639|NCT01133977|B5|Baseline|Dacarbazine (Phase 2)|Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
344640|NCT01133977|B4|Baseline|20 mg Lenvatinib + Dacarbazine (Phase 2)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
344641|NCT01133977|B3|Baseline|22 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
344642|NCT01133977|B2|Baseline|20 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
344643|NCT01133977|B1|Baseline|16 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
344644|NCT01133977|P5|Participant Flow|Dacarbazine (Phase 2)|Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
344645|NCT01133977|P4|Participant Flow|20 mg Lenvatinib + Dacarbazine (Phase 2)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
344646|NCT01133977|P3|Participant Flow|22 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
344647|NCT01133977|P2|Participant Flow|20 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
344648|NCT01133977|P1|Participant Flow|16 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
344649|NCT01133977|O2|Outcome|Dacarbazine (Phase 2)|Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
344650|NCT01133977|O1|Outcome|20 mg Lenvatinib + Dacarbazine (Phase 2)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
344651|NCT01133977|O5|Outcome|Dacarbazine (Phase 2)|Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
344652|NCT01133977|O4|Outcome|20 mg Lenvatinib + Dacarbazine (Phase 2)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
344653|NCT01133977|O3|Outcome|22 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
344654|NCT01133977|O2|Outcome|20 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
344655|NCT01133977|O1|Outcome|16 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
344656|NCT01133977|O3|Outcome|22 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
344657|NCT01133977|O2|Outcome|20 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
344658|NCT01133977|O1|Outcome|16 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit.
344659|NCT01133977|E5|Reported Event|Dacarbazine (Phase 2)|Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
344660|NCT01133977|E4|Reported Event|20 mg Lenvatinib + Dacarbazine (Phase 2)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
344661|NCT01133977|E3|Reported Event|22 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
344662|NCT01133977|E2|Reported Event|20 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
344663|NCT01133977|E1|Reported Event|16 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
344664|NCT01133860|B1|Baseline|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
344817|NCT01133522|B3|Baseline|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
344665|NCT01133860|P1|Participant Flow|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
344666|NCT01133860|O1|Outcome|Eltrombopag|In patients with more than 100 x10e9 platelets/L at the end of therapy, we evaluated also the in vitro platelet aggregation after stimulation with adenosine diphosphate (5 and 20 mcM), collagen (5 and 20 mg/mL) and ristocetin (3 mg/mL) by the densitometric method of Born in native platelet rich plasma. The extent of platelet aggregation was measured 5 minutes after the addition of stimulating agents and results obtained in patients were compared with the normal ranges in the laboratories where the assay was performed. Results are reported as the number of patients with normal platelet aggregation.
344667|NCT01133860|O1|Outcome|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
344668|NCT01133860|O1|Outcome|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
344669|NCT01133860|O1|Outcome|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
344670|NCT01133860|E1|Reported Event|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
344671|NCT01133847|B4|Baseline|Total|Total of all reporting groups
344672|NCT01133847|B3|Baseline|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
344673|NCT01133847|B2|Baseline|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
344674|NCT01133847|B1|Baseline|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
344675|NCT01133847|P3|Participant Flow|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
344676|NCT01133847|P2|Participant Flow|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
344677|NCT01133847|P1|Participant Flow|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
344678|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
344679|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
344728|NCT01133756|B1|Baseline|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
344932|NCT01133379|P1|Participant Flow|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
344680|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
344681|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
344682|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
344683|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
344684|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
344685|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
344686|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
344687|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
344688|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
344689|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
344690|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
344691|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
344692|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
344693|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
344818|NCT01133522|B2|Baseline|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
344694|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
344695|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
344696|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|"All interventions described in Reading Instruction and ADHD treatment arms:~All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training."
344697|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
344698|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
344699|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
344700|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
344701|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
344702|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
344703|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
344704|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
344705|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
344706|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
344729|NCT01133756|P3|Participant Flow|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
344933|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
344707|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
344708|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
344709|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
344710|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
344711|NCT01133847|E3|Reported Event|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
344712|NCT01133847|E2|Reported Event|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
344713|NCT01133847|E1|Reported Event|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
344714|NCT01133821|B3|Baseline|Total|Total of all reporting groups
344715|NCT01133821|B2|Baseline|IPSRT Plus Quetiapine|"Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus the FDA approved medication quetiapine (Seroquel). This condition will be called IPSRT-QUE.~IPSRT plus quetiapine: Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.~The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).~Medication Dosing~The research pharmacy will dispense medication in the following unit-dose packs:~Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
344716|NCT01133821|B1|Baseline|Placebo|"Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus placebo (sugar pill). This condition will be called IPSRT-PLA.~IPSRT plus placebo (IPSRT-PLA): Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.~The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).~Medication Dosing~The research pharmacy will dispense medication in the following unit-dose packs:~Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
344717|NCT01133821|P2|Participant Flow|IPSRT Plus Quetiapine|"Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus the FDA approved medication quetiapine (Seroquel). This condition will be called IPSRT-QUE.~IPSRT plus quetiapine: Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.~The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).~Medication Dosing~The research pharmacy will dispense medication in the following unit-dose packs:~Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
344730|NCT01133756|P2|Participant Flow|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
344731|NCT01133756|P1|Participant Flow|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (area under the concentration-time curve [AUC] 4) + gemcitabine (1000 mg/m2) intravenous (IV) infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
344934|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
344718|NCT01133821|P1|Participant Flow|Placebo|"Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus placebo (sugar pill). This condition will be called IPSRT-PLA.~IPSRT plus placebo (IPSRT-PLA): Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.~The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).~Medication Dosing~The research pharmacy will dispense medication in the following unit-dose packs:~Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
344719|NCT01133821|O2|Outcome|Placebo|"Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus placebo (sugar pill). This condition will be called IPSRT-PLA.~IPSRT plus placebo (IPSRT-PLA): Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.~The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).~Medication Dosing~The research pharmacy will dispense medication in the following unit-dose packs:~Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
344720|NCT01133821|O1|Outcome|IPSRT Plus Quetiapine|"Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus the FDA approved medication quetiapine (Seroquel). This condition will be called IPSRT-QUE.~IPSRT plus quetiapine: Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.~The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).~Medication Dosing~The research pharmacy will dispense medication in the following unit-dose packs:~Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
344721|NCT01133821|O2|Outcome|Placebo|"Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus placebo (sugar pill). This condition will be called IPSRT-PLA.~IPSRT plus placebo (IPSRT-PLA): Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.~The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).~Medication Dosing~The research pharmacy will dispense medication in the following unit-dose packs:~Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
344722|NCT01133821|O1|Outcome|IPSRT Plus Quetiapine|"Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus the FDA approved medication quetiapine (Seroquel). This condition will be called IPSRT-QUE.~IPSRT plus quetiapine: Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.~The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).~Medication Dosing~The research pharmacy will dispense medication in the following unit-dose packs:~Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
344723|NCT01133821|E2|Reported Event|IPSRT Plus Quetiapine|"Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus the FDA approved medication quetiapine (Seroquel). This condition will be called IPSRT-QUE.~IPSRT plus quetiapine: Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.~The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).~Medication Dosing~The research pharmacy will dispense medication in the following unit-dose packs:~Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
344724|NCT01133821|E1|Reported Event|Placebo|"Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus placebo (sugar pill). This condition will be called IPSRT-PLA.~IPSRT plus placebo (IPSRT-PLA): Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.~The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).~Medication Dosing~The research pharmacy will dispense medication in the following unit-dose packs:~Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
344725|NCT01133756|B4|Baseline|Total|Total of all reporting groups
344726|NCT01133756|B3|Baseline|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
344727|NCT01133756|B2|Baseline|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
344809|NCT01133522|B11|Baseline|Total|Total of all reporting groups
345975|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
344732|NCT01133756|O3|Outcome|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
344733|NCT01133756|O2|Outcome|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
344734|NCT01133756|O1|Outcome|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
344735|NCT01133756|O3|Outcome|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
344736|NCT01133756|O2|Outcome|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
344737|NCT01133756|O1|Outcome|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
344738|NCT01133756|O3|Outcome|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
344739|NCT01133756|O2|Outcome|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
344740|NCT01133756|O1|Outcome|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
344741|NCT01133756|E3|Reported Event|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) intravenous (IV) infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
344742|NCT01133756|E2|Reported Event|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
344743|NCT01133756|E1|Reported Event|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
344744|NCT01133704|B3|Baseline|Total|Total of all reporting groups
344745|NCT01133704|B2|Baseline|Placebo|"All subjects randomized to receive placebo.~Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
344746|NCT01133704|B1|Baseline|Sipuleucel-T (APC8015)|"All subjects randomized to receive sipuleucel-T.~Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
344747|NCT01133704|P2|Participant Flow|Placebo|"All subjects randomized to receive placebo.~Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
344748|NCT01133704|P1|Participant Flow|Sipuleucel-T (APC8015)|"All subjects randomized to receive sipuleucel-T.~Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
344749|NCT01133704|O2|Outcome|Placebo|"All subjects randomized to receive placebo.~Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
344750|NCT01133704|O1|Outcome|Sipuleucel-T (APC8015)|"All subjects randomized to receive sipuleucel-T.~Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
344751|NCT01133704|O2|Outcome|Placebo|"All subjects randomized to receive placebo.~Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
344752|NCT01133704|O1|Outcome|Sipuleucel-T (APC8015)|"All subjects randomized to receive sipuleucel-T.~Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
344753|NCT01133704|E2|Reported Event|Placebo|"All subjects randomized to receive placebo.~Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
344754|NCT01133704|E1|Reported Event|Sipuleucel-T (APC8015)|"All subjects randomized to receive sipuleucel-T.~Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
344755|NCT01133665|B1|Baseline|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344935|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
344756|NCT01133665|P1|Participant Flow|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344757|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344758|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344759|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344760|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344761|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344762|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344763|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344764|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344765|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344766|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344767|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344768|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344769|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344770|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344771|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344772|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344773|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344774|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344775|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344776|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344777|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344778|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344779|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344780|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344781|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344782|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344783|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344784|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344785|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344786|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344787|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344788|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344789|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344790|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344791|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344792|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344793|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344794|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344795|NCT01133665|E1|Reported Event|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
344796|NCT01133626|B4|Baseline|Total|Total of all reporting groups
344797|NCT01133626|B3|Baseline|Placebo/Prednisone|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.
344798|NCT01133626|B2|Baseline|Placebo|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
344799|NCT01133626|B1|Baseline|BDP HFA 320 µg/Day|Participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
344800|NCT01133626|P3|Participant Flow|Placebo/Prednisone|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.
344801|NCT01133626|P2|Participant Flow|Placebo|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
344802|NCT01133626|P1|Participant Flow|BDP HFA 320 µg/Day|Participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
344803|NCT01133626|O3|Outcome|Placebo/Prednisone|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.
344804|NCT01133626|O2|Outcome|Placebo|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
344805|NCT01133626|O1|Outcome|BDP HFA 320 µg/Day|Participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
344806|NCT01133626|E3|Reported Event|Placebo/Prednisone|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.
344807|NCT01133626|E2|Reported Event|Placebo|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
344808|NCT01133626|E1|Reported Event|BDP HFA 320 µg/Day|Participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
344819|NCT01133522|B1|Baseline|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
344820|NCT01133522|P10|Participant Flow|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
344821|NCT01133522|P9|Participant Flow|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
344822|NCT01133522|P8|Participant Flow|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
344823|NCT01133522|P7|Participant Flow|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
344824|NCT01133522|P6|Participant Flow|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks (Q4W) for 8 weeks.
344825|NCT01133522|P5|Participant Flow|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
344826|NCT01133522|P4|Participant Flow|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks (Q2W) for 6 weeks.
344827|NCT01133522|P3|Participant Flow|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
344828|NCT01133522|P2|Participant Flow|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly (QW) for 6 weeks.
344829|NCT01133522|P1|Participant Flow|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
344830|NCT01133522|O10|Outcome|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
344831|NCT01133522|O9|Outcome|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
344832|NCT01133522|O8|Outcome|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
344833|NCT01133522|O7|Outcome|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
344834|NCT01133522|O6|Outcome|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
344835|NCT01133522|O5|Outcome|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
344836|NCT01133522|O4|Outcome|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
344837|NCT01133522|O3|Outcome|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
344838|NCT01133522|O2|Outcome|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
344839|NCT01133522|O1|Outcome|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
344840|NCT01133522|O10|Outcome|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
344841|NCT01133522|O9|Outcome|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
344842|NCT01133522|O8|Outcome|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
344843|NCT01133522|O7|Outcome|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
344844|NCT01133522|O6|Outcome|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
344845|NCT01133522|O5|Outcome|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
344846|NCT01133522|O4|Outcome|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
344847|NCT01133522|O3|Outcome|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
344848|NCT01133522|O2|Outcome|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
344849|NCT01133522|O1|Outcome|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
344850|NCT01133522|O7|Outcome|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
344851|NCT01133522|O6|Outcome|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
344852|NCT01133522|O5|Outcome|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
344853|NCT01133522|O4|Outcome|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
344854|NCT01133522|O3|Outcome|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
344856|NCT01133522|O1|Outcome|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
344857|NCT01133522|O10|Outcome|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
344858|NCT01133522|O9|Outcome|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
344859|NCT01133522|O8|Outcome|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
344860|NCT01133522|O7|Outcome|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
344861|NCT01133522|O6|Outcome|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
344862|NCT01133522|O5|Outcome|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
344863|NCT01133522|O4|Outcome|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
344864|NCT01133522|O3|Outcome|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
344865|NCT01133522|O2|Outcome|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
344866|NCT01133522|O1|Outcome|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
344867|NCT01133522|O7|Outcome|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
344868|NCT01133522|O6|Outcome|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
344869|NCT01133522|O5|Outcome|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
344870|NCT01133522|O4|Outcome|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
344871|NCT01133522|O3|Outcome|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
344872|NCT01133522|O2|Outcome|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
344873|NCT01133522|O1|Outcome|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
344874|NCT01133522|O10|Outcome|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
344875|NCT01133522|O9|Outcome|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
344876|NCT01133522|O8|Outcome|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
344877|NCT01133522|O7|Outcome|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
344878|NCT01133522|O6|Outcome|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
344879|NCT01133522|O5|Outcome|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
344880|NCT01133522|O4|Outcome|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
344881|NCT01133522|O3|Outcome|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
344882|NCT01133522|O2|Outcome|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
344883|NCT01133522|O1|Outcome|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
344884|NCT01133522|E10|Reported Event|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
344885|NCT01133522|E9|Reported Event|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
344886|NCT01133522|E8|Reported Event|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
344887|NCT01133522|E7|Reported Event|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
344888|NCT01133522|E6|Reported Event|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
344889|NCT01133522|E5|Reported Event|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
344890|NCT01133522|E4|Reported Event|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
344891|NCT01133522|E3|Reported Event|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
345976|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
344892|NCT01133522|E2|Reported Event|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
344893|NCT01133522|E1|Reported Event|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
344894|NCT01133418|B3|Baseline|Total|Total of all reporting groups
344895|NCT01133418|B2|Baseline|Non-progressive Cognitive Training|"Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance.~Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty"
344896|NCT01133418|B1|Baseline|Cognitive Training|"Computerized Progressive Attention Training~Computerized Progressive Attention Training: Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability"
344897|NCT01133418|P2|Participant Flow|Non-progressive Cognitive Training|"Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance.~Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty"
344898|NCT01133418|P1|Participant Flow|Cognitive Training|"Computerized Progressive Attention Training~Computerized Progressive Attention Training: Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability"
344899|NCT01133418|O2|Outcome|Non-progressive Cognitive Training|"Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance.~Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty"
344900|NCT01133418|O1|Outcome|Cognitive Training|"Computerized Progressive Attention Training~Computerized Progressive Attention Training: Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability"
344901|NCT01133418|O2|Outcome|Non-progressive Cognitive Training|"Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance.~Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty"
344902|NCT01133418|O1|Outcome|Cognitive Training|"Computerized Progressive Attention Training~Computerized Progressive Attention Training: Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability"
344903|NCT01133418|O2|Outcome|Non-progressive Cognitive Training|"Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance.~Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty"
352898|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
344904|NCT01133418|O1|Outcome|Cognitive Training|"Computerized Progressive Attention Training~Computerized Progressive Attention Training: Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability"
344905|NCT01133418|O2|Outcome|Non-progressive Cognitive Training|"Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance.~Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty"
344906|NCT01133418|O1|Outcome|Cognitive Training|"Computerized Progressive Attention Training~Computerized Progressive Attention Training: Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability"
344907|NCT01133418|E2|Reported Event|Non-progressive Cognitive Training|"Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance.~Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty"
344908|NCT01133418|E1|Reported Event|Cognitive Training|"Computerized Progressive Attention Training~Computerized Progressive Attention Training: Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability"
344909|NCT01133392|B3|Baseline|Total|Total of all reporting groups
344910|NCT01133392|B2|Baseline|Insulin Lispro Dosing Sequence BABA|Each participant was administered insulin lispro A formulation (Treatment A, test – 2 occasions) and insulin lispro B formulation (Treatment B, reference – 2 occasions) in the dosing sequence BABA.
344911|NCT01133392|B1|Baseline|Insulin Lispro Dosing Sequence ABAB|Each participant was administered insulin lispro A formulation (Treatment A, test – 2 occasions) and insulin lispro B formulation (Treatment B, reference – 2 occasions) in the dosing sequence ABAB.
344912|NCT01133392|P2|Participant Flow|Insulin Lispro Dosing Sequence BABA|Each participant was administered insulin lispro A formulation (Treatment A, test – 2 occasions) and insulin lispro B formulation (Treatment B, reference – 2 occasions) in the dosing sequence BABA. There was an interval of approximately 4 to 7 days between doses.
344913|NCT01133392|P1|Participant Flow|Insulin Lispro Dosing Sequence ABAB|Each participant was administered insulin lispro A formulation (Treatment A, test – 2 occasions) and insulin lispro B formulation (Treatment B, reference – 2 occasions) in the dosing sequence ABAB. There was an interval of approximately 4 to 7 days between doses.
344914|NCT01133392|O2|Outcome|Insulin Lispro B|20 units (U) administered subcutaneously (SC)
344915|NCT01133392|O1|Outcome|Insulin Lispro A|20 units (U) administered subcutaneously (SC)
344916|NCT01133392|O2|Outcome|Insulin Lispro B|20 units (U) administered subcutaneously (SC)
344917|NCT01133392|O1|Outcome|Insulin Lispro A|20 units (U) administered subcutaneously (SC)
344918|NCT01133392|O2|Outcome|Insulin Lispro B|20 units (U) administered subcutaneously (SC)
344919|NCT01133392|O1|Outcome|Insulin Lispro A|20 units (U) administered subcutaneously (SC)
344920|NCT01133392|O2|Outcome|Insulin Lispro B|20 units (U) administered subcutaneously (SC)
344921|NCT01133392|O1|Outcome|Insulin Lispro A|20 units (U) administered subcutaneously (SC)
344922|NCT01133392|O2|Outcome|Insulin Lispro B|20 units (U) administered subcutaneously (SC)
344923|NCT01133392|O1|Outcome|Insulin Lispro A|20 units (U) administered subcutaneously (SC)
344924|NCT01133392|E2|Reported Event|Insulin Lispro B|Insulin lispro B formulation (Treatment B, reference – 2 occasions)
344925|NCT01133392|E1|Reported Event|Insulin Lispro A|Insulin lispro A formulation (Treatment A, test – 2 occasions)
344926|NCT01133379|B4|Baseline|Total|Total of all reporting groups
344927|NCT01133379|B3|Baseline|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
344928|NCT01133379|B2|Baseline|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
344929|NCT01133379|B1|Baseline|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
344930|NCT01133379|P3|Participant Flow|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
352899|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
344937|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
344938|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
344939|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
344940|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
344941|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
344942|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
344943|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
344944|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
344945|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
344946|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
344947|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
344948|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
344949|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
344950|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
344951|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
344952|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
344953|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
344954|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
344955|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
344956|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
344957|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
344958|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
344959|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
344960|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
344961|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
344962|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
344963|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
344964|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
344965|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
344966|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
344967|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
344968|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
344969|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
344970|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
344971|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
344972|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
344973|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
344974|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
344975|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
344976|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
344977|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
344978|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
344979|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
344980|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
344981|NCT01133379|E3|Reported Event|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
344982|NCT01133379|E2|Reported Event|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
344983|NCT01133379|E1|Reported Event|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
344984|NCT01133288|B1|Baseline|Yulex Glove|Yulex Glove Treatment
344985|NCT01133288|P1|Participant Flow|Yulex Glove|Yulex Glove Treatment
344986|NCT01133288|O1|Outcome|Yulex Glove|Yulex Glove Treatment
344987|NCT01133288|O1|Outcome|Yulex Glove|Yulex Glove Treatment
344988|NCT01133288|E1|Reported Event|Yulex Glove|Yulex Glove Treatment
344989|NCT01133275|B1|Baseline|Lenalidomide and Prednisone Therapy|Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
344990|NCT01133275|P1|Participant Flow|Lenalidomide and Prednisone Therapy|Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
344991|NCT01133275|O1|Outcome|Lenalidomide and Prednisone Therapy|Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
344992|NCT01133275|O1|Outcome|Lenalidomide and Prednisone Therapy|Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
344993|NCT01133275|E1|Reported Event|Lenalidomide and Prednisone Therapy|Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
344994|NCT01133171|B4|Baseline|Total|Total of all reporting groups
344995|NCT01133171|B3|Baseline|Control|
344996|NCT01133171|B2|Baseline|Nurse Alone|
344997|NCT01133171|B1|Baseline|Dashboard Plus Nurse|
344998|NCT01133171|P3|Participant Flow|Control|
344999|NCT01133171|P2|Participant Flow|Nurse Alone|
345000|NCT01133171|P1|Participant Flow|Dashboard Plus Nurse|
345001|NCT01133171|O3|Outcome|Control|
345002|NCT01133171|O2|Outcome|Nurse Alone|
345003|NCT01133171|O1|Outcome|Dashboard Plus Nurse|
345004|NCT01133171|O2|Outcome|Nurse Alone|
345005|NCT01133171|O1|Outcome|Dashboard Plus Nurse|
345006|NCT01133171|E3|Reported Event|Control|
345007|NCT01133171|E2|Reported Event|Nurse Alone|
345008|NCT01133171|E1|Reported Event|Dashboard Plus Nurse|
345009|NCT01132846|B4|Baseline|Total|Total of all reporting groups
345010|NCT01132846|B3|Baseline|Low Dose Nesiritide|"Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
345011|NCT01132846|B2|Baseline|Placebo|"Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
345012|NCT01132846|B1|Baseline|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
345013|NCT01132846|P3|Participant Flow|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
345014|NCT01132846|P2|Participant Flow|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
345015|NCT01132846|P1|Participant Flow|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
345016|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
345017|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
345018|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
345019|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
345020|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
345021|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
345022|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
345023|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
345024|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
345025|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
345026|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
345074|NCT01132690|B2|Baseline|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
345977|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
345027|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
345028|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
345029|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
345030|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
345031|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
345032|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
345033|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
345034|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
345035|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
345036|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
345037|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
345038|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
345039|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
345040|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
345041|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
345042|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
345043|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
345044|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
345045|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
345046|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
345047|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
345048|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
345978|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
345049|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
345050|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
345051|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
345052|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
345053|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
345054|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
345055|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
345056|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
345057|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
345058|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
345059|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
345060|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
345061|NCT01132846|E3|Reported Event|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
345062|NCT01132846|E2|Reported Event|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
345063|NCT01132846|E1|Reported Event|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
345064|NCT01132820|B1|Baseline|Cediranib|Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
345065|NCT01132820|P1|Participant Flow|Cediranib|Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
345066|NCT01132820|O1|Outcome|Cediranib|Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
345067|NCT01132820|O1|Outcome|Cediranib|Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
345068|NCT01132820|O1|Outcome|Cediranib|Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
345069|NCT01132820|O1|Outcome|Cediranib|Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
345070|NCT01132820|O1|Outcome|Cediranib|Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
345071|NCT01132820|O1|Outcome|Cediranib|Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
345072|NCT01132820|E1|Reported Event|Cediranib|Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
345073|NCT01132690|B3|Baseline|Total|Total of all reporting groups
345075|NCT01132690|B1|Baseline|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
345076|NCT01132690|P2|Participant Flow|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
345077|NCT01132690|P1|Participant Flow|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
345078|NCT01132690|O2|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
345079|NCT01132690|O1|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
345080|NCT01132690|O2|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
345081|NCT01132690|O1|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
345082|NCT01132690|O2|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
345083|NCT01132690|O1|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
345084|NCT01132690|O2|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
345085|NCT01132690|O1|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
345086|NCT01132690|O2|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
345087|NCT01132690|O1|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
345088|NCT01132690|O2|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
345089|NCT01132690|O1|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
345090|NCT01132690|E2|Reported Event|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
345091|NCT01132690|E1|Reported Event|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
345092|NCT01132664|B6|Baseline|Total|Total of all reporting groups
345093|NCT01132664|B5|Baseline|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
345094|NCT01132664|B4|Baseline|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
345095|NCT01132664|B3|Baseline|Phase II - 100mg|Patients in the phase II only expansion cohort who received 100 mg of buparlisib - investigational drug
345096|NCT01132664|B2|Baseline|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
345097|NCT01132664|B1|Baseline|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
345098|NCT01132664|P5|Participant Flow|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
345099|NCT01132664|P4|Participant Flow|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
345100|NCT01132664|P3|Participant Flow|Phase II - 100mg|Patients in the phase II expansion + patients from phase Ib dose escalation were included in phase II and received 100 mg of investigational drug - buparsilib
345101|NCT01132664|P2|Participant Flow|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
345102|NCT01132664|P1|Participant Flow|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
345103|NCT01132664|O5|Outcome|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
345104|NCT01132664|O4|Outcome|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
345105|NCT01132664|O3|Outcome|Phase II - 100mg|Patients in the phase II expansion + patients from phase Ib escalation included in phase II
345106|NCT01132664|O2|Outcome|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
345107|NCT01132664|O1|Outcome|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
345108|NCT01132664|O5|Outcome|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
345109|NCT01132664|O4|Outcome|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
345110|NCT01132664|O3|Outcome|Phase II - 100mg|Patients in the phase II expansion + patients from phase Ib escalation included in phase II
345111|NCT01132664|O2|Outcome|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
345112|NCT01132664|O1|Outcome|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
345113|NCT01132664|O5|Outcome|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
345114|NCT01132664|O4|Outcome|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
345115|NCT01132664|O3|Outcome|Phase II - 100mg|Patients in the phase II expansion + patients from phase Ib escalation included in phase II
345116|NCT01132664|O2|Outcome|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
345117|NCT01132664|O1|Outcome|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
345118|NCT01132664|O5|Outcome|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
345119|NCT01132664|O4|Outcome|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
345120|NCT01132664|O3|Outcome|Phase II - 100mg|Patients in the phase II expansion + patients from phase Ib escalation included in phase II
345121|NCT01132664|O2|Outcome|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
345122|NCT01132664|O1|Outcome|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
345123|NCT01132664|O5|Outcome|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
345124|NCT01132664|O4|Outcome|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
345125|NCT01132664|O3|Outcome|Phase II - 100mg|Patients in the phase II expansion + patients from phase Ib escalation included in phase II
345126|NCT01132664|O2|Outcome|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
345127|NCT01132664|O1|Outcome|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
345128|NCT01132664|E5|Reported Event|BM Cohort 100 mg/Day|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
345129|NCT01132664|E4|Reported Event|BM Cohort 80 mg/Day|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
345130|NCT01132664|E3|Reported Event|Phase II Dose Expansion 100 mg/Day|Patients in the phase II expansion + patients from phase Ib dose escalation who received 100 mg/day of buparlisib - investigational drug
345131|NCT01132664|E2|Reported Event|Phase Ib Dose Escalation 100 mg/Day|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
345132|NCT01132664|E1|Reported Event|Phase Ib Dose Escalation 50 mg/Day|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug.
345133|NCT01132651|B3|Baseline|Total|Total of all reporting groups
345134|NCT01132651|B2|Baseline|Control (Normal Pillow)|This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
345135|NCT01132651|B1|Baseline|Chillow (Cooling Pillow)|This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.
345136|NCT01132651|P2|Participant Flow|Control (Normal Pillow)|This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
345137|NCT01132651|P1|Participant Flow|Chillow (Cooling Pillow)|This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.
345138|NCT01132651|O2|Outcome|Control (Normal Pillow)|This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
345139|NCT01132651|O1|Outcome|Chillow (Cooling Pillow)|This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.
345140|NCT01132651|O2|Outcome|Control (Normal Pillow)|This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
345141|NCT01132651|O1|Outcome|Chillow (Cooling Pillow)|This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.
345142|NCT01132651|E2|Reported Event|Control (Normal Pillow)|This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
345143|NCT01132651|E1|Reported Event|Chillow (Cooling Pillow)|This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.
345144|NCT01132612|B4|Baseline|Total|Total of all reporting groups
345145|NCT01132612|B3|Baseline|Open-label|Secukinumab 150 mg sc administered every 4 weeks.
345146|NCT01132612|B2|Baseline|Treatment at Start of Relapse Regimen|Placebo administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter. If relapse, then switch to secukinumab 150 mg sc administered every 4 weeks
345147|NCT01132612|B1|Baseline|Fixed-time Interval Regimen|Secukinumab 150 mg subcutaneous (sc) administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter
345148|NCT01132612|P3|Participant Flow|Open-label|Secukinumab 150 mg sc administered every 4 weeks.
345149|NCT01132612|P2|Participant Flow|Treatment at Start of Relapse Regimen|Placebo administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter. If relapse, then switch to secukinumab 150 mg sc administered every 4 weeks
345150|NCT01132612|P1|Participant Flow|Fixed-time Interval Regimen|Secukinumab 150 mg subcutaneous (sc) administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter
345151|NCT01132612|O3|Outcome|Open-label|Secukinumab 150 mg sc administered every 4 weeks.
345152|NCT01132612|O2|Outcome|Treatment at Start of Relapse Regimen|Placebo administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter. If relapse, then switch to secukinumab 150 mg sc administered every 4 weeks
345153|NCT01132612|O1|Outcome|Fixed-time Interval Regimen|Secukinumab 150 mg subcutaneous (sc) administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter
345154|NCT01132612|O3|Outcome|Open-label|Secukinumab 150 mg sc administered every 4 weeks.
345155|NCT01132612|O2|Outcome|Treatment at Start of Relapse Regimen|Placebo administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter. If relapse, then switch to secukinumab 150 mg sc administered every 4 weeks
345156|NCT01132612|O1|Outcome|Fixed-time Interval Regimen|Secukinumab 150 mg subcutaneous (sc) administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter
345157|NCT01132612|O3|Outcome|Open-label|Secukinumab 150 mg sc administered every 4 weeks.
345158|NCT01132612|O2|Outcome|Treatment at Start of Relapse Regimen|Placebo administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter. If relapse, then switch to secukinumab 150 mg sc administered every 4 weeks
345159|NCT01132612|O1|Outcome|Fixed-time Interval Regimen|Secukinumab 150 mg subcutaneous (sc) administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter
345160|NCT01132612|E3|Reported Event|Open-label|Secukinumab 150 mg sc administered every 4 weeks.
345161|NCT01132612|E2|Reported Event|Treatment at Start of Relapse Regimen|Placebo administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter. If relapse, then switch to secukinumab 150 mg sc administered every 4 weeks
345162|NCT01132612|E1|Reported Event|Fixed-time Interval Regimen|Secukinumab 150 mg subcutaneous (sc) administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter
345163|NCT01132547|B3|Baseline|Total|Total of all reporting groups
345164|NCT01132547|B2|Baseline|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.~placebo: Given orally"
345413|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
345165|NCT01132547|B1|Baseline|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.~cyproheptadine hydrochloride: Given orally"
345166|NCT01132547|P2|Participant Flow|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.~placebo: Given orally"
345167|NCT01132547|P1|Participant Flow|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.~cyproheptadine hydrochloride: Given orally"
345168|NCT01132547|O2|Outcome|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.~placebo: Given orally"
345169|NCT01132547|O1|Outcome|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.~cyproheptadine hydrochloride: Given orally"
345170|NCT01132547|O2|Outcome|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.~placebo: Given orally"
345171|NCT01132547|O1|Outcome|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.~cyproheptadine hydrochloride: Given orally"
345172|NCT01132547|O2|Outcome|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.~placebo: Given orally"
345173|NCT01132547|O1|Outcome|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.~cyproheptadine hydrochloride: Given orally"
345174|NCT01132547|E2|Reported Event|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.~placebo: Given orally"
345175|NCT01132547|E1|Reported Event|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.~cyproheptadine hydrochloride: Given orally"
345176|NCT01132508|B1|Baseline|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345177|NCT01132508|P1|Participant Flow|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345178|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345179|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345180|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345181|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345182|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345183|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345184|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345185|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345186|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345414|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
345187|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345188|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345189|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345190|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345191|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345192|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345193|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345194|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345195|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345196|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345197|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345198|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345199|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345200|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345201|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345618|NCT01130974|P1|Participant Flow|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
345202|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345203|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345204|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345205|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345206|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345207|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345208|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345209|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345210|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345211|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345212|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345213|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345214|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345215|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345216|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345619|NCT01130974|O2|Outcome|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
345217|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345218|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345219|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345220|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345221|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345222|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345223|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345224|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345225|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345226|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345227|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345228|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345229|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345230|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345231|NCT01132508|E1|Reported Event|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
345232|NCT01132495|B5|Baseline|Total|Total of all reporting groups
345233|NCT01132495|B4|Baseline|Cohort B - No Follow-up Re-consented|Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data
345234|NCT01132495|B3|Baseline|Cohort B - Follow-up|Observation with treatment based on physician preference
345235|NCT01132495|B2|Baseline|Cohort A - OMT Alone|"Optimal medical treatment alone~Standard of care: OMT alone"
345236|NCT01132495|B1|Baseline|Cohort A - PCI Plus OMT|"PCI plus optimal medical treatment~Stenting plus OMT: FFR guided PCI, plus OMT"
345237|NCT01132495|P4|Participant Flow|Cohort B - No Follow-up Re-consented|Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data
345238|NCT01132495|P3|Participant Flow|Cohort B - Follow-up|Observation with treatment based on physician preference
345239|NCT01132495|P2|Participant Flow|Cohort A - OMT Alone|"Optimal medical treatment alone~Standard of care: OMT alone"
345240|NCT01132495|P1|Participant Flow|Cohort A - PCI Plus OMT|"PCI plus optimal medical treatment~Stenting plus OMT: FFR guided PCI, plus OMT"
345241|NCT01132495|O2|Outcome|Cohort A - OMT Alone|Optimal medical treatment alone - Standard of care: OMT alone
345242|NCT01132495|O1|Outcome|Cohort A - PCI Plus OMT|PCI plus optimal medical treatment - Stenting plus OMT: FFR guided PCI, plus OMT
345243|NCT01132495|E4|Reported Event|Cohort B - No Follow-up Re-consented|Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data
345244|NCT01132495|E3|Reported Event|Cohort B - Follow-up|Observation with treatment based on physician preference
345245|NCT01132495|E2|Reported Event|Cohort A - OMT Alone|"Optimal medical treatment alone~Standard of care: OMT alone"
345246|NCT01132495|E1|Reported Event|Cohort A - PCI Plus OMT|"PCI plus optimal medical treatment~Stenting plus OMT: FFR guided PCI, plus OMT"
345247|NCT01132378|B1|Baseline|Median Parepatellar Approach or Minimidvastus Approach|Total knee arthroplasty : staged bilateral total knee arthroplasty
345248|NCT01132378|P1|Participant Flow|Mini-midvastus Incision|"Total knee arthroplasty : staged bilateral total knee arthroplasty~Forty consecutive patients who underwent staged bilateral Total Knee Arthroplasty were prospectively randomised to receive mini-midvastus approach in one knee and mini-Medial Parapatellar Approachthe in another knee (left or right)within no more than 7 days."
345249|NCT01132378|O2|Outcome|Mini-midvastus Approach|Total knee arthroplasty : staged bilateral total knee arthroplasty
345250|NCT01132378|O1|Outcome|Medial Parapatellar Approach|Forty consecutive patients who underwent staged bilateral Total Knee Arthroplasty were prospectively randomised to receive mini MedialParapatellar Approach in one knee and mini-midvastus approach in the other knee (left or right)within no more than 7 days.
345251|NCT01132378|E1|Reported Event|Midvastus or Medial Parapatellar Approach|Forty consecutive patients who underwent staged bilateral Total Knee Arthroplasty were prospectively randomised to receive mini MedialParapatellar Approach in one knee and mini-midvastus approach in the other knee (left or right)within no more than 7 days.
345252|NCT01132326|B1|Baseline|Droxidopa|"Open-Label Droxidopa~Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months"
345253|NCT01132326|P1|Participant Flow|Droxidopa|"Open-Label Droxidopa~Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months"
345254|NCT01132326|O1|Outcome|Droxidopa|"Open-Label Droxidopa~Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months"
345255|NCT01132326|E1|Reported Event|Droxidopa|"Open-Label Droxidopa~Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months"
345256|NCT01132313|B13|Baseline|Total|Total of all reporting groups
345257|NCT01132313|B12|Baseline|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
345258|NCT01132313|B11|Baseline|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
345259|NCT01132313|B10|Baseline|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345260|NCT01132313|B9|Baseline|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345261|NCT01132313|B8|Baseline|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345262|NCT01132313|B7|Baseline|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345263|NCT01132313|B6|Baseline|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345264|NCT01132313|B5|Baseline|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345265|NCT01132313|B4|Baseline|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345266|NCT01132313|B3|Baseline|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345267|NCT01132313|B2|Baseline|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
345268|NCT01132313|B1|Baseline|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
345269|NCT01132313|P12|Participant Flow|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
345270|NCT01132313|P11|Participant Flow|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
345271|NCT01132313|P10|Participant Flow|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345272|NCT01132313|P9|Participant Flow|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345273|NCT01132313|P8|Participant Flow|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345274|NCT01132313|P7|Participant Flow|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345275|NCT01132313|P6|Participant Flow|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345276|NCT01132313|P5|Participant Flow|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345277|NCT01132313|P4|Participant Flow|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345278|NCT01132313|P3|Participant Flow|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345279|NCT01132313|P2|Participant Flow|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
345280|NCT01132313|P1|Participant Flow|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
345281|NCT01132313|O5|Outcome|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
345282|NCT01132313|O4|Outcome|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
345283|NCT01132313|O3|Outcome|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345284|NCT01132313|O2|Outcome|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345285|NCT01132313|O1|Outcome|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345286|NCT01132313|O5|Outcome|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
345287|NCT01132313|O4|Outcome|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
345288|NCT01132313|O3|Outcome|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345289|NCT01132313|O2|Outcome|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345290|NCT01132313|O1|Outcome|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345291|NCT01132313|O5|Outcome|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345292|NCT01132313|O4|Outcome|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345293|NCT01132313|O3|Outcome|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345294|NCT01132313|O2|Outcome|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345295|NCT01132313|O1|Outcome|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345296|NCT01132313|O7|Outcome|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345297|NCT01132313|O6|Outcome|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345298|NCT01132313|O5|Outcome|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345299|NCT01132313|O4|Outcome|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345300|NCT01132313|O3|Outcome|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345301|NCT01132313|O2|Outcome|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
345302|NCT01132313|O1|Outcome|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
345303|NCT01132313|O5|Outcome|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345304|NCT01132313|O4|Outcome|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345305|NCT01132313|O3|Outcome|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345306|NCT01132313|O2|Outcome|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345307|NCT01132313|O1|Outcome|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345308|NCT01132313|O2|Outcome|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
345309|NCT01132313|O1|Outcome|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
345310|NCT01132313|O5|Outcome|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
345311|NCT01132313|O4|Outcome|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
345312|NCT01132313|O3|Outcome|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345313|NCT01132313|O2|Outcome|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345314|NCT01132313|O1|Outcome|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345315|NCT01132313|O5|Outcome|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345316|NCT01132313|O4|Outcome|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345317|NCT01132313|O3|Outcome|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345318|NCT01132313|O2|Outcome|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345319|NCT01132313|O1|Outcome|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345320|NCT01132313|O2|Outcome|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
345321|NCT01132313|O1|Outcome|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
345322|NCT01132313|E12|Reported Event|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
345323|NCT01132313|E11|Reported Event|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
345324|NCT01132313|E10|Reported Event|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345325|NCT01132313|E9|Reported Event|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345326|NCT01132313|E8|Reported Event|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345327|NCT01132313|E7|Reported Event|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345328|NCT01132313|E6|Reported Event|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345329|NCT01132313|E5|Reported Event|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345330|NCT01132313|E4|Reported Event|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345331|NCT01132313|E3|Reported Event|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
345415|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
345416|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
345332|NCT01132313|E2|Reported Event|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
345333|NCT01132313|E1|Reported Event|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
345334|NCT01132144|B3|Baseline|Total|Total of all reporting groups
345335|NCT01132144|B2|Baseline|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
345336|NCT01132144|B1|Baseline|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
345337|NCT01132144|P2|Participant Flow|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds
345338|NCT01132144|P1|Participant Flow|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
345339|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
345340|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
345341|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
345342|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
345343|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
345344|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
345345|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
345346|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
345347|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
345348|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
345349|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds
345350|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
345351|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
345417|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
345979|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
345352|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
345353|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
345354|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation.
345355|NCT01132144|E2|Reported Event|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
345356|NCT01132144|E1|Reported Event|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
345357|NCT01132118|B3|Baseline|Total|Total of all reporting groups
345358|NCT01132118|B2|Baseline|Placebo Then HCQ|"This arm of the study contains half the study population after randomization. The participants in this arm received hydroxychloroquine for 8 weeks and then crossed over to a placebo for 8 weeks. Study staff was blinded to which order they were taking the hydroxychloroquine and placebo in.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
345359|NCT01132118|B1|Baseline|HCQ Then Placebo|"This arm of the study contains half the study population after randomization. The participants in this arm received hydroxychloroquine for 8 weeks and then crossed over to a placebo for 8 weeks. Study staff was blinded to which order they were taking the hydroxychloroquine and placebo in.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
345360|NCT01132118|P2|Participant Flow|Placebo Then HCQ|"This arm of the study contains half the study population after randomization. The participants in this arm received hydroxychloroquine for 8 weeks and then crossed over to a placebo for 8 weeks. Study staff was blinded to which order they were taking the hydroxychloroquine and placebo in.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
345361|NCT01132118|P1|Participant Flow|HCQ Then Placebo|"This arm of the study contains half the study population after randomization. The participants in this arm received hydroxychloroquine for 8 weeks and then crossed over to a placebo for 8 weeks. Study staff was blinded to which order they were taking the hydroxychloroquine and placebo in.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
345362|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
345363|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
345364|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
345365|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
345366|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
345367|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
345368|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
345369|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
345370|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
345371|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
345372|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
345418|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
345980|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
345373|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
345374|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
345375|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
345376|NCT01132118|E2|Reported Event|Placebo|Participants received Placebo tablets for 8 weeks.
345377|NCT01132118|E1|Reported Event|Hydroxychloroquine|"Participants received hydroxychloroquine (HCQ) for 8 weeks.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
345378|NCT01131884|B3|Baseline|Total|Total of all reporting groups
345379|NCT01131884|B2|Baseline|Placebo Sugar Pill|"Double blind study using Fosamax versus placebo. Placebo is an inactive drug.~Placebo : Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo."
345380|NCT01131884|B1|Baseline|Fosamax|Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
345381|NCT01131884|P2|Participant Flow|Placebo Sugar Pill|"Double blind study using Fosamax versus placebo. Placebo is an inactive drug.~Placebo : Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo."
345382|NCT01131884|P1|Participant Flow|Fosamax|Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
345383|NCT01131884|O2|Outcome|Placebo Sugar Pill|"Double blind study using Fosamax versus placebo. Placebo is an inactive drug.~Placebo : Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo."
345384|NCT01131884|O1|Outcome|Fosamax|Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
345385|NCT01131884|E2|Reported Event|Placebo Sugar Pill|"Double blind study using Fosamax versus placebo. Placebo is an inactive drug.~Placebo : Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo."
345386|NCT01131884|E1|Reported Event|Fosamax|Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
345387|NCT01131676|B4|Baseline|Total|Total of all reporting groups
345388|NCT01131676|B3|Baseline|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
345389|NCT01131676|B2|Baseline|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
345390|NCT01131676|B1|Baseline|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
345391|NCT01131676|P3|Participant Flow|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
345392|NCT01131676|P2|Participant Flow|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
345393|NCT01131676|P1|Participant Flow|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
345394|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
345395|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
345396|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
345397|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
345398|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
345399|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
345400|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
345401|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
345402|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
345403|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
345404|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
345405|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
345406|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
345407|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
345408|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
345409|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
345410|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
345411|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
345412|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
345981|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
345419|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
345420|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
345421|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
345422|NCT01131676|E3|Reported Event|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
345423|NCT01131676|E2|Reported Event|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
345424|NCT01131676|E1|Reported Event|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
345425|NCT01131585|B3|Baseline|Total|Total of all reporting groups
345426|NCT01131585|B2|Baseline|Active Laser Photocoagulation and Sham Injection|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Sham intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
345427|NCT01131585|B1|Baseline|Active Laser Photocoagulation and Ranibizumab|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Ranibizumab intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
345428|NCT01131585|P2|Participant Flow|Active Laser Photocoagulation and Sham Injection|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Sham intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
345429|NCT01131585|P1|Participant Flow|Active Laser Photocoagulation and Ranibizumab|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Ranibizumab intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
345430|NCT01131585|O2|Outcome|Active Laser Photocoagulation and Sham Injection|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Sham intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
345431|NCT01131585|O1|Outcome|Active Laser Photocoagulation and Ranibizumab|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Ranibizumab intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
345432|NCT01131585|E2|Reported Event|Active Laser Photocoagulation and Sham Injection|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Sham intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
345433|NCT01131585|E1|Reported Event|Active Laser Photocoagulation and Ranibizumab|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Ranibizumab intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
345434|NCT01131520|B3|Baseline|Total|Total of all reporting groups
345435|NCT01131520|B2|Baseline|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing~Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
345436|NCT01131520|B1|Baseline|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use~Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
345437|NCT01131520|P2|Participant Flow|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing~Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
345438|NCT01131520|P1|Participant Flow|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use~Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
345439|NCT01131520|O2|Outcome|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing~Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
345440|NCT01131520|O1|Outcome|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use~Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
345441|NCT01131520|O2|Outcome|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing~Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
345442|NCT01131520|O1|Outcome|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use~Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
345443|NCT01131520|O2|Outcome|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing~Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
345503|NCT01131182|O2|Outcome|Sulfonylurea|Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription.
345504|NCT01131182|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally daily over the Ramadan period.
345444|NCT01131520|O1|Outcome|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use~Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
345445|NCT01131520|O2|Outcome|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing~Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
345446|NCT01131520|O1|Outcome|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use~Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
345447|NCT01131520|O2|Outcome|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing~Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
345448|NCT01131520|O1|Outcome|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use~Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
345449|NCT01131520|O2|Outcome|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing~Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
345450|NCT01131520|O1|Outcome|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use~Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
345451|NCT01131520|O2|Outcome|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing~Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
345452|NCT01131520|O1|Outcome|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use~Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
345453|NCT01131520|O2|Outcome|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing~Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
345454|NCT01131520|O1|Outcome|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use~Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
345455|NCT01131520|O2|Outcome|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing~Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
345456|NCT01131520|O1|Outcome|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use~Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
345457|NCT01131520|E2|Reported Event|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing~Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
345458|NCT01131520|E1|Reported Event|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use~Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
345459|NCT01131507|B1|Baseline|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kg body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
345460|NCT01131507|P1|Participant Flow|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kilogram (kg) of body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
345461|NCT01131507|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kg body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
345462|NCT01131507|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kg body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
345463|NCT01131507|E1|Reported Event|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce will be administered orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kg body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
345464|NCT01131494|B1|Baseline|Swallowing Exercise Group|One group made swallowing exercises for five weeks. This group was compared before and after the study.
345465|NCT01131494|P1|Participant Flow|Swallowing Exercise Group|One group made swallowing exercises for five weeks. This group was compared before and after the study.
345466|NCT01131494|O2|Outcome|Post-intervention Measure|Measurements of the group made after the intervention.
345467|NCT01131494|O1|Outcome|Pre-intervention Measure|Measurements of the group made before begin intervention.
345468|NCT01131494|O2|Outcome|Post-intervention Measure|Measurements of the group made after the intervention.
345469|NCT01131494|O1|Outcome|Pre-intervention Measure|Measurements of the group made before begin intervention.
345470|NCT01131494|E1|Reported Event|Swallowing Exercise Group|One group made swallowing exercises for five weeks. This group was compared before and after the study.
345471|NCT01131455|B4|Baseline|Total|Total of all reporting groups
345472|NCT01131455|B3|Baseline|Standard-Fusion +Autograft Only|Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with blunt dissection through the capsule and penetration to the joint. Depending on the randomization of the subject, ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.
345473|NCT01131455|B2|Baseline|Fusion + ACP +DBM|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). Depending on the randomization of the subject, (Autologous Concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a healing process wherever they are applied. The Arthrex ACP System is a cost-effective method of concentrating growth factors for therapeutic use."
345474|NCT01131455|B1|Baseline|Fusion+ACP+Autograft|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus, external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with dissection through the capsule and penetration to the joint. Standard debridement of the gutters, tibia osteophyte, tibia-talor joint resection and autograft preparation will be performed in the joint. Depending on randomization of the subject, (Autologous concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a h"
345475|NCT01131455|P3|Participant Flow|Standard-Fusion +Autograft Only|Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with blunt dissection through the capsule and penetration to the joint. Depending on the randomization of the subject, ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.
345476|NCT01131455|P2|Participant Flow|Fusion + ACP +DBM|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). Depending on the randomization of the subject, (Autologous Concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a healing process wherever they are applied. The Arthrex ACP System is a cost-effective method of concentrating growth factors for therapeutic use."
345477|NCT01131455|P1|Participant Flow|Fusion+ACP+Autograft|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus, external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with dissection through the capsule and penetration to the joint. Standard debridement of the gutters, tibia osteophyte, tibia-talor joint resection and autograft preparation will be performed in the joint. Depending on randomization of the subject, (Autologous concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a h"
345478|NCT01131455|O3|Outcome|Standard-Fusion +Autograft Only|Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with blunt dissection through the capsule and penetration to the joint. Depending on the randomization of the subject, ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.
345505|NCT01131182|E2|Reported Event|Sulfonylurea|Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription.
345506|NCT01131182|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg administered orally daily over the Ramadan period.
345479|NCT01131455|O2|Outcome|Fusion + ACP +DBM|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). Depending on the randomization of the subject, (Autologous Concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a healing process wherever they are applied. The Arthrex ACP System is a cost-effective method of concentrating growth factors for therapeutic use."
345480|NCT01131455|O1|Outcome|Fusion+ACP+Autograft|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus, external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with dissection through the capsule and penetration to the joint. Standard debridement of the gutters, tibia osteophyte, tibia-talor joint resection and autograft preparation will be performed in the joint. Depending on randomization of the subject, (Autologous concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a h"
345481|NCT01131455|E3|Reported Event|Standard-Fusion +Autograft Only|Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with blunt dissection through the capsule and penetration to the joint. Depending on the randomization of the subject, ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.
345482|NCT01131455|E2|Reported Event|Fusion + ACP +DBM|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). Depending on the randomization of the subject, (Autologous Concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a healing process wherever they are applied. The Arthrex ACP System is a cost-effective method of concentrating growth factors for therapeutic use."
345483|NCT01131455|E1|Reported Event|Fusion+ACP+Autograft|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus, external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with dissection through the capsule and penetration to the joint. Standard debridement of the gutters, tibia osteophyte, tibia-talor joint resection and autograft preparation will be performed in the joint. Depending on randomization of the subject, (Autologous concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a h"
345484|NCT01131299|B1|Baseline|Alpha Cyclodextrin & Placebo Participants|"Randomized subjects receiving alpha cyclodextrin~Alpha cyclodextrin: 2 g PO 3 times a day for 12- 14 weeks~Randomized subjects receiving placebo comparator~Placebo: 2 tablets PO 3 times a day for 12-14 weeks"
345485|NCT01131299|P2|Participant Flow|Alpha Cyclodextrin First, Then Placebo|"Subjects will receive alpha cyclodextrin: 2 tablets PO 3 times a day for 12-14 weeks. After a one-week washout, the subjects will receive placebo.~Subjects will receive placebo 2 tablets orally (three times a day) for 12-14 weeks"
345486|NCT01131299|P1|Participant Flow|Placebo First, Then Alpha Cyclodextrin|"Randomized subjects will receive placebo 2 tablets orally (three times a day) for 12-14 weeks. After a one-week washout, the subjects will receive alpha cyclodextrin.~Alpha cyclodextrin: 2 tablets PO 3 times a day for 12-14 weeks"
345487|NCT01131299|O2|Outcome|Placebo|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
345488|NCT01131299|O1|Outcome|a-CD|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
345489|NCT01131299|O2|Outcome|Placebo|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
345490|NCT01131299|O1|Outcome|a-CD|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
345491|NCT01131299|O2|Outcome|Placebo|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
345492|NCT01131299|O1|Outcome|a-CD|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
345493|NCT01131299|O2|Outcome|Placebo|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
345494|NCT01131299|O1|Outcome|a-CD|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
345495|NCT01131299|E1|Reported Event|Entire Study Population|"Randomized subjects receiving active comparator~Alpha cyclodextrin: 2g PO 3 times a day for 12-14 weeks~Randomized subjects receiving placebo comparator~Placebo: 2 tablets PO 3 times a day for 12-14 weeks"
345496|NCT01131182|B3|Baseline|Total|Total of all reporting groups
345497|NCT01131182|B2|Baseline|Sulfonylurea|Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription. All participants as treated population, n=514.
345498|NCT01131182|B1|Baseline|Sitagliptin|Sitagliptin 100 mg administered orally daily over the Ramadan period. All participants as treated population, n=507.
345499|NCT01131182|P2|Participant Flow|Sulfonylurea|Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription
345500|NCT01131182|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg administered orally daily over the Ramadan period
345501|NCT01131182|O2|Outcome|Sulfonylurea|Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription.
345502|NCT01131182|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally daily over the Ramadan period.
345507|NCT01131130|B1|Baseline|Over All Study|Participants were equally randomized to one of six treatment sequences of the investigational RD2106 contact lens (Test), the Air Optix Aqua contact lens, and the Acuvue Oasys contact lens. Crossover occurred following 1 week of lens wear. The 6 groups were as follows Test, Air Optix Aqua, Acuvue Oasys; Test, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, Test, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, Test; Acuvue Oasys, Test, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, Test.
345508|NCT01131130|P1|Participant Flow|Over All Study|Participants were equally randomized to one of six treatment sequences of the investigational RD2106 contact lens (Test), the Air Optix Aqua contact lens, and the Acuvue Oasys contact lens. Crossover occurred following 1 week of lens wear. The 6 groups were as follows Test, Air Optix Aqua, Acuvue Oasys; Test, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, Test, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, Test; Acuvue Oasys, Test, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, Test.
345509|NCT01131130|O2|Outcome|Air Optix Aqua|"Ciba Vision~Air Optix Aqua: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
345510|NCT01131130|O1|Outcome|Investigational Contact Lens|"Bausch & Lomb~Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
345511|NCT01131130|O2|Outcome|Acuvue Oasys Contact Lens|"Johnson & Johnson Lens~Acuvue Oasys Contact Lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
345512|NCT01131130|O1|Outcome|Investigational Contact Lens|"Bausch & Lomb~Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
345513|NCT01131130|O2|Outcome|Air Optix Aqua|"Ciba Vision~Air Optix Aqua: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
345514|NCT01131130|O1|Outcome|Investigational Contact Lens|"Bausch & Lomb~Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
345515|NCT01131130|O2|Outcome|Acuvue Oasys Contact Lens|"Johnson & Johnson Lens~Acuvue Oasys Contact Lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
345516|NCT01131130|O1|Outcome|Investigational Contact Lens|"Bausch & Lomb~Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
345517|NCT01131130|E3|Reported Event|Air Optix Aqua|"Ciba Vision~Air Optix Aqua: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
345518|NCT01131130|E2|Reported Event|Acuvue Oasys Contact Lens|"Johnson & Johnson Lens~Acuvue Oasys Contact Lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
345519|NCT01131130|E1|Reported Event|Investigational Contact Lens|"Bausch & Lomb~Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
345520|NCT01131104|B1|Baseline|Cohort 1|Participants with NAION who have used PDE5 inhibitors
345521|NCT01131104|P1|Participant Flow|Enrolled Set|Enrolled participants who met inclusion/exclusion criteria and had physician-diagnosed NAION with a known date of onset.
345522|NCT01131104|O1|Outcome|Cohort 1|Participants with NAION who have used PDE5 inhibitors
345523|NCT01131104|E1|Reported Event|Cohort 1|Participants with NAION who have used PDE5 inhibitors.
345524|NCT01131078|B4|Baseline|Total|Total of all reporting groups
345525|NCT01131078|B3|Baseline|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
345526|NCT01131078|B2|Baseline|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345527|NCT01131078|B1|Baseline|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345528|NCT01131078|P3|Participant Flow|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
345529|NCT01131078|P2|Participant Flow|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345620|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
352900|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
345530|NCT01131078|P1|Participant Flow|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 milligrams per kilogram (mg/kg) intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 milligrams per meter squared (mg/m^2) intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or stable disease (SD) were treated with bevacizumab alone until unacceptable toxicity, progressive disease (PD), or participant withdrawal.
345531|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
345532|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345533|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345534|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
345535|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345536|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345537|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
345538|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345539|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345540|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
345541|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345542|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345621|NCT01130974|O2|Outcome|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
345543|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
345544|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345545|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345546|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
345547|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345548|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345549|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
345550|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345551|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345552|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
345553|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345554|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345555|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
345582|NCT01131078|E3|Reported Event|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
345556|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345557|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345558|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
345559|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal..
345560|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345561|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
345562|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345563|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345564|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
345565|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345566|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345567|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
345568|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345614|NCT01130974|B3|Baseline|Total|Total of all reporting groups
345615|NCT01130974|B2|Baseline|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
345616|NCT01130974|B1|Baseline|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
345569|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345570|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
345571|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345572|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345573|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
345574|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345575|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345576|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
345577|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345578|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345579|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
345580|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345581|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345617|NCT01130974|P2|Participant Flow|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
345982|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
345583|NCT01131078|E2|Reported Event|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345584|NCT01131078|E1|Reported Event|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
345585|NCT01131065|B1|Baseline|Hepatitis B Immune Globulin|"Treatment group~Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
345586|NCT01131065|P1|Participant Flow|Hepatitis B Immune Globulin|"Treatment group~Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
345587|NCT01131065|O1|Outcome|Hepatitis B Immune Globulin|"Treatment group~Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
345588|NCT01131065|O1|Outcome|Hepatitis B Immune Globulin|"Treatment group~Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
345589|NCT01131065|O1|Outcome|Hepatitis B Immune Globulin|"Treatment group~Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
345590|NCT01131065|E1|Reported Event|Hepatitis B Immune Globulin|"Treatment group~Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
345591|NCT01131052|B3|Baseline|Total|Total of all reporting groups
345592|NCT01131052|B2|Baseline|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
345593|NCT01131052|B1|Baseline|BASAL PLUS|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
345594|NCT01131052|P2|Participant Flow|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
345595|NCT01131052|P1|Participant Flow|BASAL PLUS|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
345596|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
345597|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
345598|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
345599|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
345600|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
345601|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
345602|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
345603|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
345604|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
345605|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
345606|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
345607|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
345608|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
345609|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
345610|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
345611|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
345612|NCT01131052|E2|Reported Event|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
345613|NCT01131052|E1|Reported Event|BASAL PLUS|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
345622|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
345623|NCT01130974|O2|Outcome|Marketed Contact Lens|Marketed daily disposable cosmetic tint contact lens
345624|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
345625|NCT01130974|O2|Outcome|Marketed Contact Lens|Marketed daily disposable cosmetic tint contact lens
345626|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
345627|NCT01130974|O2|Outcome|Marketed Contact Lens|Marketed daily disposable cosmetic tint contact lens
345628|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
345629|NCT01130974|O2|Outcome|Marketed Contact Lens|Marketed daily disposable cosmetic tint contact lens
345630|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
345631|NCT01130974|O2|Outcome|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
345632|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
345633|NCT01130974|O2|Outcome|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
345634|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
345635|NCT01130974|E2|Reported Event|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
345636|NCT01130974|E1|Reported Event|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
345637|NCT01130883|B1|Baseline|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
345638|NCT01130883|P1|Participant Flow|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
345639|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
345640|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
345641|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
345642|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
345643|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
345644|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
345645|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
345646|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
345647|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
345648|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
345649|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
345650|NCT01130883|E1|Reported Event|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
345651|NCT01130844|B4|Baseline|Total|Total of all reporting groups
345652|NCT01130844|B3|Baseline|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
352901|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
345653|NCT01130844|B2|Baseline|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345654|NCT01130844|B1|Baseline|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345655|NCT01130844|P3|Participant Flow|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345656|NCT01130844|P2|Participant Flow|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345657|NCT01130844|P1|Participant Flow|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345658|NCT01130844|O3|Outcome|MMX Mesalamine Metabolite (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345659|NCT01130844|O2|Outcome|MMX Mesalamine Metabolite (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345660|NCT01130844|O1|Outcome|MMX Mesalamine Metabolite (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345661|NCT01130844|O3|Outcome|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345662|NCT01130844|O2|Outcome|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345663|NCT01130844|O1|Outcome|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345664|NCT01130844|O3|Outcome|MMX Mesalamine Metabolite (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345665|NCT01130844|O2|Outcome|MMX Mesalamine Metabolite (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345666|NCT01130844|O1|Outcome|MMX Mesalamine Metabolite (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345667|NCT01130844|O3|Outcome|MMX Mesalamine Metabolite (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345668|NCT01130844|O2|Outcome|MMX Mesalamine Metabolite (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345669|NCT01130844|O1|Outcome|MMX Mesalamine Metabolite (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345670|NCT01130844|O3|Outcome|MMX Mesalamine Metabolite (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345671|NCT01130844|O2|Outcome|MMX Mesalamine Metabolite (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345672|NCT01130844|O1|Outcome|MMX Mesalamine Metabolite (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345673|NCT01130844|O3|Outcome|MMX Mesalamine Metabolite (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345674|NCT01130844|O2|Outcome|MMX Mesalamine Metabolite (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345675|NCT01130844|O1|Outcome|MMX Mesalamine Metabolite (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345676|NCT01130844|O3|Outcome|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345677|NCT01130844|O2|Outcome|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345678|NCT01130844|O1|Outcome|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345679|NCT01130844|O3|Outcome|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345680|NCT01130844|O2|Outcome|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345681|NCT01130844|O1|Outcome|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345682|NCT01130844|O3|Outcome|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345683|NCT01130844|O2|Outcome|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345684|NCT01130844|O1|Outcome|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345685|NCT01130844|O3|Outcome|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345686|NCT01130844|O2|Outcome|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345687|NCT01130844|O1|Outcome|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345688|NCT01130844|O3|Outcome|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345689|NCT01130844|O2|Outcome|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345690|NCT01130844|O1|Outcome|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345691|NCT01130844|E3|Reported Event|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345692|NCT01130844|E2|Reported Event|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345693|NCT01130844|E1|Reported Event|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
345694|NCT01130831|B1|Baseline|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
345695|NCT01130831|P1|Participant Flow|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
345696|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
345697|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
345698|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
345699|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
345700|NCT01130831|O1|Outcome|Calcium-based Phosphate Binder Therapy|Calcium-based phosphate binder therapy for >=3 months prior.
345701|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
345702|NCT01130831|O1|Outcome|Calcium-based Phosphate Binder Therapy|Calcium-based phosphate binder therapy of >=3 months of treatment.
345703|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
345704|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
345705|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
345706|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
345707|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
345708|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
345709|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that maintained the iPTH KDOQI target on lanthanum carbonate.
345710|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that achieved the serum phosphate KDOQI target on lanthanum carbonate after previous calcium-based phosphate binder therapy treatment for >=3 months.
345711|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that maintained the serum calcium-phosphorous product KDOQI target on lanthanum carbonate.
345712|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that maintained the serum calcium KDOQI target on lanthanum carbonate.
345713|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that maintained the serum phosphorous KDOQI target on lanthanum carbonate.
345714|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that achieved the serum calcium-phosphorous product levels KDOQI target on lanthanum carbonate after previous calcium-based phosphate binder therapy treatment for >=3 months.
345715|NCT01130831|O1|Outcome|Calcium-based Phosphate Binder Therapy|The percent of subjects that achieved the serum calcium-phosphorous product KDOQI target on previous calcium-based phosphate binder therapy for >=3 months prior to receiving lanthanum carbonate treatment.
345716|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that achieved the serum calcium KDOQI target on lanthanum carbonate after previous calcium-based phosphate binder therapy treatment for >=3 months.
345717|NCT01130831|O1|Outcome|Calcium-based Phosphate Binder Therapy|The percent of subjects that achieved the serum calcium KDOQI target on previous calcium-based phosphate binder therapy for >=3 months prior to receiving lanthanum carbonate treatment.
345718|NCT01130831|O1|Outcome|Calcium-based Phosphate Binder Therapy|The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of >=3 months of treatment prior to receiving lanthanum carbonate treatment.
345719|NCT01130831|E1|Reported Event|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
345720|NCT01130740|B3|Baseline|Total|Total of all reporting groups
345721|NCT01130740|B2|Baseline|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.~Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
345722|NCT01130740|B1|Baseline|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
345723|NCT01130740|P2|Participant Flow|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.~Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
345724|NCT01130740|P1|Participant Flow|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
345725|NCT01130740|O2|Outcome|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.~Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
345726|NCT01130740|O1|Outcome|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
345744|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
345775|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
345727|NCT01130740|O2|Outcome|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.~Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
345728|NCT01130740|O1|Outcome|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
345729|NCT01130740|O2|Outcome|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.~Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
345730|NCT01130740|O1|Outcome|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
345731|NCT01130740|E2|Reported Event|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.~Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
345732|NCT01130740|E1|Reported Event|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
345733|NCT01130597|B1|Baseline|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
345734|NCT01130597|P1|Participant Flow|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
345735|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
345736|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
345737|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
345738|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
345739|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
345740|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
345741|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
345742|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
345743|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
352902|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
345745|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
345746|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
345747|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
345748|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
345749|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
345750|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
345751|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
345752|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
345753|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
345754|NCT01130597|E1|Reported Event|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
345755|NCT01130532|B4|Baseline|Total|Total of all reporting groups
345756|NCT01130532|B3|Baseline|Placebo|Placebo for 12 weeks during double-blind treatment period.
345757|NCT01130532|B2|Baseline|5 mg Tadalafil|5.0 mg Tadalafil for 12 weeks during double-blind treatment period.
345758|NCT01130532|B1|Baseline|2.5 mg Titrated to 5 mg Tadalafil|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period.
345759|NCT01130532|P4|Participant Flow|5 mg Tadalafil Open-Label Extension|5 mg Tadalafil for 4 weeks during open-label treatment extension period.
345760|NCT01130532|P3|Participant Flow|Placebo|Placebo for 12 weeks during double-blind treatment period.
345761|NCT01130532|P2|Participant Flow|5 mg Tadalafil|5.0 mg Tadalafil for 12 weeks during double-blind treatment period.
345762|NCT01130532|P1|Participant Flow|2.5 mg Titrated to 5 mg Tadalafil|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period.
345763|NCT01130532|O3|Outcome|Placebo (Period IV)|5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
345764|NCT01130532|O2|Outcome|5 mg Tadalafil (Period IV)|5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
345765|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period IV)|5.0 milligram (mg) Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
345766|NCT01130532|O3|Outcome|Placebo (Period IV)|5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
345767|NCT01130532|O2|Outcome|5 mg Tadalafil (Period IV)|5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
345768|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period IV)|5.0 milligram (mg) Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
345769|NCT01130532|O3|Outcome|Placebo (Period IV)|5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
345770|NCT01130532|O2|Outcome|5 mg Tadalafil (Period IV)|5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
345771|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period IV)|5.0 milligram (mg) Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
345772|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
345773|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
345774|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
345821|NCT01130493|E4|Reported Event|Washout|Participants receive open-label IPX066 for 1 week
345776|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
345777|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
345778|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
345779|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
345780|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
345781|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
345782|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
345783|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
345784|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
345785|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
345786|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
345787|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
345788|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
345789|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
345790|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
345791|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
345792|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
345793|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
345794|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
345795|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
345796|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
345797|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
345798|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
345799|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
345800|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
345801|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
345802|NCT01130532|E4|Reported Event|5 mg Tadalafil Open-Label Extension|5 mg Tadalafil for 4 weeks during open-label treatment extension period.
345803|NCT01130532|E3|Reported Event|Placebo|Placebo for 12 weeks during double-blind treatment period.
345804|NCT01130532|E2|Reported Event|5 mg Tadalafil|5.0 mg Tadalafil for 12 weeks during double-blind treatment period.
345805|NCT01130532|E1|Reported Event|2.5 mg Titrated to 5 mg Tadalafil|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period.
345806|NCT01130493|B1|Baseline|All Study Participants|Participants who were randomized to receive either IPX066 or IR CD-LD in Part 1 of the study and then IPX066 in Part 2 (open-label extension).
345807|NCT01130493|P3|Participant Flow|CLE-Open Label IPX066 Washout-IPX066-OLE|CLE (Per Protocol: Part 1 Period 1), Open-label washout IPX066, IPX066 (Per Protocol: Part 1 Period 2), OLE (Per Protocol: Part 2)
345808|NCT01130493|P2|Participant Flow|IPX066-Open-label IPX066 Washout-CLE-OLE|IPX066 (Per Protocol: Part 1 Period 1), Open-label washout IPX066, CLE (Per Protocol: Part 1 Period 2), OLE (Per Protocol: Part 2)
345809|NCT01130493|P1|Participant Flow|IPX066 Conversion|All subjects were converted to IPX066 during an open-label period
345810|NCT01130493|O3|Outcome|Number of Participants Who Had no Preference|Participants who completed both treatment periods and who did not indicate a preference for either treatment
345811|NCT01130493|O2|Outcome|Number of Participants Who Preferred CLE|Participants who completed both treatment periods and who had a preference for CLE
345812|NCT01130493|O1|Outcome|Number of Participants Who Preferred IPX066|Participants who completed both treatment periods and who had a preference for IPX066
345813|NCT01130493|O2|Outcome|CLE (Active Comparator)|Participants who received CLE in either Period 1 or Period 2
345814|NCT01130493|O1|Outcome|IPX066|Participants who received IPX066 in either Period 1 or Period 2
345815|NCT01130493|O2|Outcome|CLE (Active Comparator)|Participants who received CLE in either Period 1 or Period 2
345816|NCT01130493|O1|Outcome|IPX066|Participants who received IPX066 in either Period 1 or Period 2
345817|NCT01130493|O2|Outcome|CLE (Active Comparator)|Participants who received CLE in either Period 1 or Period 2
345818|NCT01130493|O1|Outcome|IPX066|Participants who received IPX066 in either Period 1 or Period 2
345819|NCT01130493|O2|Outcome|CLE (Active Comparator)|Participants who received CLE in either Period 1 or Period 2
345820|NCT01130493|O1|Outcome|IPX066|Participants who received IPX066 in either Period 1 or Period 2
352903|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
345822|NCT01130493|E3|Reported Event|CLE (Active Comparator)|Participants first received 2 weeks of CLE followed by an approximate 7-day washout period of IPX066 treatment followed by another 2 weeks of IPX066.
345823|NCT01130493|E2|Reported Event|IPX066|Participants first received 2 weeks of IPX066 followed by an approximate 7-day washout period of IPX066 treatment followed by another 2 weeks of CLE.
345824|NCT01130493|E1|Reported Event|Dose Conversion|Participants were to be converted from stable doses of CLE to open-label IPX066 over a 6-week period
345825|NCT01130337|B1|Baseline|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
345826|NCT01130337|P1|Participant Flow|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 milligrams per meter squared [mg/m^2] tablet orally [p.o] twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute intravenous [IV] infusion, Day 1 of the cycle)/trastuzumab (8 milligrams per kilograms [mg/kg] on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
345827|NCT01130337|O1|Outcome|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
345828|NCT01130337|O1|Outcome|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
345829|NCT01130337|O1|Outcome|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
345830|NCT01130337|O1|Outcome|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
345831|NCT01130337|E1|Reported Event|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
345832|NCT01130168|B1|Baseline|All Participants|
345833|NCT01130168|P6|Participant Flow|Amlodipine/ISMN ER/Placebo (Sequence 6)|Participants received Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 1, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 2, followed by a dose-matched Placebo capsule for 4 weeks during Period, with a 2-week washout between each period.
345834|NCT01130168|P5|Participant Flow|Placebo/Amlodipine/ISMN ER (Sequence 5)|Participants received a dose-matched Placebo capsule orally for 4 weeks during Period 1, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 2, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 3, with a 2-week washout between each period.
345835|NCT01130168|P4|Participant Flow|ISMN ER/Placebo/Amlodipine (Sequence 4)|Participants received a ISMN ER 30 mg capsule orally for 4 weeks during Period 1, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 2, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 3, with a 2-week washout between each period.
345836|NCT01130168|P3|Participant Flow|Amlodipine/Placebo/ISMN ER (Sequence 3)|Participants received Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 1, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 2, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 3, with a 2-week washout between each period
345837|NCT01130168|P2|Participant Flow|ISMN ER/Amlodipine/Placebo (Sequence 2)|Participants received a ISMN ER 30 mg capsule orally for 4 weeks during Period 1, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 2, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 3, with a 2-week washout between each period
345838|NCT01130168|P1|Participant Flow|Placebo/ISMN ER/Amlodipine (Sequence 1)|Participants received a dose-matched Placebo capsule orally for 4 weeks during Period 1, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 2, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 3, with a 2-week washout between each period. Experimental: ISMN ER/Amlodipine/Placebo
345974|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
345839|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
345840|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
345841|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
345842|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
345843|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
345844|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
345845|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
345846|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
345847|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
345848|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
345849|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
345850|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
345851|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
345852|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
345853|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
345854|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
345855|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
345856|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
345857|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
345858|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
345859|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
345860|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
345861|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
345862|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
345863|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
345864|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
345865|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
345866|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
345867|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
345868|NCT01130168|O1|Outcome|ISMN ER|Isosorbide mononitrate extended release (ISMN ER) was administered as a 30 mg single daily dose over 4 weeks.
345869|NCT01130168|E3|Reported Event|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
345870|NCT01130168|E2|Reported Event|ISMN ER|Isosorbide mononitrate extended release (ISMN ER) was administered as a 30 mg single daily dose over 4 weeks.
345871|NCT01130168|E1|Reported Event|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
345872|NCT01130103|B3|Baseline|Total|Total of all reporting groups
345873|NCT01130103|B2|Baseline|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
345874|NCT01130103|B1|Baseline|Paroxetine|Paroxetine and Prolonged Exposure Therapy
345875|NCT01130103|P2|Participant Flow|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
345876|NCT01130103|P1|Participant Flow|Paroxetine|Paroxetine and Prolonged Exposure Therapy
345877|NCT01130103|O2|Outcome|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
345878|NCT01130103|O1|Outcome|Paroxetine|Paroxetine and Prolonged Exposure Therapy
345879|NCT01130103|O2|Outcome|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
345880|NCT01130103|O1|Outcome|Paroxetine|Paroxetine and Prolonged Exposure Therapy
345881|NCT01130103|O2|Outcome|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
345882|NCT01130103|O1|Outcome|Paroxetine|Paroxetine and Prolonged Exposure Therapy
345883|NCT01130103|O2|Outcome|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
345884|NCT01130103|O1|Outcome|Paroxetine|Paroxetine and Prolonged Exposure Therapy
345885|NCT01130103|O2|Outcome|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
345886|NCT01130103|O1|Outcome|Paroxetine|Paroxetine and Prolonged Exposure Therapy
345887|NCT01130103|E2|Reported Event|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
345888|NCT01130103|E1|Reported Event|Paroxetine|Paroxetine and Prolonged Exposure Therapy
345889|NCT01130051|B1|Baseline|Colcrys® Intact Tab and Colcrys® in Applesauce|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of intact Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce, following an overnight fast of at least 10 hours.
345890|NCT01130051|P2|Participant Flow|Colcrys® Sprinkled on Applesauce Then Colcrys® Intact Tab|On the morning of Day 1 subjects received one tablet of the test formulation, Colcrys® 0.6 mg, crushed and sprinkled on applesauce, after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received one dose of the reference formulation, one intact Colcrys® 0.6 mg tablet, after an overnight fast of at least 10 hours
345891|NCT01130051|P1|Participant Flow|Colcrys® Intact Tab Then Colcrys® Sprinkled on Applesauce|On the morning of Day 1, subjects received the reference formulation, one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received the test formulation, one Colcrys® 0.6 mg tablet crushed and sprinkled on applesauce, after an overnight fast of at least 10 hours
345892|NCT01130051|O2|Outcome|Colcrys® 0.6 mg Tablet Crushed and Sprinkled on Applesauce|Each subject received one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce after an overnight fast of at least 10 hours
345893|NCT01130051|O1|Outcome|Colcrys® 0.6 mg Administered as an Intact Tablet|Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
345894|NCT01130051|O2|Outcome|Colcrys® 0.6 mg Tablet Crushed and Sprinkled on Applesauce|Each subject received one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce after an overnight fast of at least 10 hours
345895|NCT01130051|O1|Outcome|Colcrys® 0.6 mg Administered as an Intact Tablet|Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
345896|NCT01130051|O2|Outcome|Colcrys® 0.6 mg Tablet Crushed and Sprinkled on Applesauce|Each subject received one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce after an overnight fast of at least 10 hours
345897|NCT01130051|O1|Outcome|Colcrys® 0.6 mg Administered as an Intact Tablet|Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
345898|NCT01130051|E2|Reported Event|Colcrys® 0.6 mg Tablet Crushed and Sprinkled on Applesauce|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one intact tablet of Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce, following an overnight fast of at least 10 hours.
345899|NCT01130051|E1|Reported Event|Colcrys® 0.6 mg Tablet Administered Intact|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one intact tablet of Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce, following an overnight fast of at least 10 hours.
345900|NCT01129960|B5|Baseline|Total|Total of all reporting groups
345901|NCT01129960|B4|Baseline|Placebo|Placebo: Tablets will be used.
345902|NCT01129960|B3|Baseline|Esl 800 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
345903|NCT01129960|B2|Baseline|Esl 1200 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
345904|NCT01129960|B1|Baseline|Esl 1600 mg|Eslicarbazepine acetate (Esl) (BIA 2-093) mg once daily (QD): Tablets will be used.
345905|NCT01129960|P4|Participant Flow|Placebo|Placebo: Tablets will be used.
345906|NCT01129960|P3|Participant Flow|Esl 800 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
345907|NCT01129960|P2|Participant Flow|Esl 1200 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
345908|NCT01129960|P1|Participant Flow|Esl 1600 mg|Eslicarbazepine acetate (Esl) (BIA 2-093) mg once daily (QD): Tablets will be used.
345909|NCT01129960|O4|Outcome|Placebo|Placebo: Tablets will be used.
345910|NCT01129960|O3|Outcome|Esl 800 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
345911|NCT01129960|O2|Outcome|Esl 1200 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
345912|NCT01129960|O1|Outcome|Esl 1600 mg|Eslicarbazepine acetate (Esl) (BIA 2-093) mg once daily (QD): Tablets will be used.
345913|NCT01129960|E4|Reported Event|Placebo|Placebo: Tablets will be used.
345914|NCT01129960|E3|Reported Event|Esl 800 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
345915|NCT01129960|E2|Reported Event|Esl 1200 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
345916|NCT01129960|E1|Reported Event|Esl 1600 mg|Eslicarbazepine acetate (Esl) (BIA 2-093) mg once daily (QD): Tablets will be used.
345917|NCT01129921|B3|Baseline|Total|Total of all reporting groups
345918|NCT01129921|B2|Baseline|Sham Procedure|Group 2: sham decompression with trocar placement and no bone or tissue removal
345919|NCT01129921|B1|Baseline|Mild Procedure|Group 1: mild percutaneous decompression with removal of bone and tissue
345920|NCT01129921|P2|Participant Flow|Sham Then Percutaneous Decompression With Mild|Group 2: After post-treatment Week 6 and prior to Week 12, patients in Sham procedure arm were allowed to participate in the active (mild procedure) study arm in which bone and tissue were removed using the mild device kit.
345921|NCT01129921|P1|Participant Flow|Percutaneous Decompression Procedure Only|Group 1: Percutaneous decompression procedure with removal of bone and tissue using the mild device kit
345922|NCT01129921|O2|Outcome|Sham Then Percutaneous Decompression With Mild|Sham Group 2 Year-1 Cohort: After cross-over to the active mild procedure study arm in which bone and tissue were removed using the mild device kit.
345923|NCT01129921|O1|Outcome|Percutaneous Decompression Procedure Only|Mild Group 1 Year-1 Cohort: Percutaneous decompression procedure with removal of bone and tissue using the mild device kit
345924|NCT01129921|O2|Outcome|Sham Group 2 Year-1 Cohort After X-over to Mild|Group 2: After post-treatment Week 6 and prior to Week 12, patients in Sham procedure arm were allowed to participate in the active (mild procedure) study arm in which bone and tissue were removed using the mild device kit.
345925|NCT01129921|O1|Outcome|Mild Group 1 Year-1 Cohort|Group 1: Percutaneous decompression procedure with removal of bone and tissue using the mild device kit
345926|NCT01129921|O2|Outcome|Sham Procedure Group 2 Prior to Cross-over|Sham placement of trocar as in percutaneous decompression, with no bone or tissue removal.
345927|NCT01129921|O1|Outcome|Mild Procedure Group 1|Percutaneous decompression with removal of small amounts of bone and tissue to relieve stenosis.
345928|NCT01129921|E2|Reported Event|Sham Procedure With Optional Crossover to Mild Post-unblinding|Sham procedure includes percutaneous trocar placement with no tissue or bone removal.
345929|NCT01129921|E1|Reported Event|Mild Procedure|percutaneous decompression with bone and tissue removal
345930|NCT01129778|B1|Baseline|Received Zegerid (Ome-NaBic)|Ome-NaBic 40 mg orally 1 h before breakfast and bedtime for up to 29 days
345931|NCT01129778|P1|Participant Flow|Received Zegerid (Ome-NaBic)|Ome-NaBic 40 mg orally 1 h before breakfast and bedtime for up to 29 days
345932|NCT01129778|O1|Outcome|Received Zegerid (Ome-NaBic)|Ome-NaBic 40 mg orally 1 h before breakfast and bedtime for up to 29 days
345933|NCT01129778|O1|Outcome|Received Zegerid (Ome-NaBic)|Ome-NaBic 40 mg orally 1 h before breakfast and bedtime for up to 29 days
345934|NCT01129778|E1|Reported Event|Received Zegerid (Ome-NaBic)|Ome-NaBic 40 mg orally 1 h before breakfast and bedtime for up to 29 days
352904|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
345935|NCT01129765|B1|Baseline|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
345936|NCT01129765|P1|Participant Flow|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
345937|NCT01129765|O1|Outcome|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
345938|NCT01129765|O1|Outcome|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
345939|NCT01129765|O1|Outcome|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
345940|NCT01129765|O1|Outcome|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
345941|NCT01129765|O1|Outcome|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
345942|NCT01129765|O1|Outcome|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
345943|NCT01129765|E1|Reported Event|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
345944|NCT01129622|B1|Baseline|Letrozole, Breast Enhancement, Safety|Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.
345945|NCT01129622|P1|Participant Flow|Letrozole, Breast Enhancement, Safety|Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.
345946|NCT01129622|O1|Outcome|Adverse Events|Hypo-estrogenic side effects
345947|NCT01129622|O1|Outcome|Letrozole, Breast Enhancement, Safety|Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.
345948|NCT01129622|E1|Reported Event|Letrozole, Breast Enhancement, Safety|Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.
345949|NCT01129583|B3|Baseline|Total|Total of all reporting groups
345950|NCT01129583|B2|Baseline|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
345951|NCT01129583|B1|Baseline|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
345952|NCT01129583|P2|Participant Flow|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
345953|NCT01129583|P1|Participant Flow|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
345954|NCT01129583|O2|Outcome|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
345955|NCT01129583|O1|Outcome|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
345956|NCT01129583|O2|Outcome|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
345957|NCT01129583|O1|Outcome|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
345958|NCT01129583|O2|Outcome|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
345959|NCT01129583|O1|Outcome|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
345960|NCT01129583|E2|Reported Event|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
345961|NCT01129583|E1|Reported Event|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
345962|NCT01129557|B4|Baseline|Total|Total of all reporting groups
345963|NCT01129557|B3|Baseline|Tekturna+Diovan|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 150 mg by mouth once daily for 9 months & Diovan (Valsartan), an angiotensin receptor blocker (ARB) 160 mg by mouth once daily for 9 months
345964|NCT01129557|B2|Baseline|Tekturna|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months
345965|NCT01129557|B1|Baseline|Diovan|Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months
345966|NCT01129557|P3|Participant Flow|Tekturna + Diovan|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 150 mg by mouth once daily for 9 months & Diovan (Valsartan), an angiotensin receptor blocker (ARB) 160 mg by mouth once daily for 9 months
345967|NCT01129557|P2|Participant Flow|Tekturna|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months
345968|NCT01129557|P1|Participant Flow|Diovan|Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months
345969|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
345970|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
345971|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
345972|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
345973|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
345983|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
345984|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
345985|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
345986|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
345987|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
345988|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
345989|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
345990|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
345991|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
345992|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
345993|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
345994|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
345995|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
345996|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
345997|NCT01129557|O8|Outcome|9 Months: Subjects With Aldosterone Breakthrough|
345998|NCT01129557|O7|Outcome|6 Months: Subjects With Aldosterone Breakthrough|
345999|NCT01129557|O6|Outcome|3 Months: Subjects With Aldosterone Breakthrough|
346000|NCT01129557|O5|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
346001|NCT01129557|O4|Outcome|9 Months: Subjects Without Aldosterone Breakthrough|
346002|NCT01129557|O3|Outcome|6 Months: Subjects Without Aldosterone Breakthrough|
346003|NCT01129557|O2|Outcome|3 Months: Subjects Without Aldosterone Breakthrough|
346004|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
346005|NCT01129557|O8|Outcome|9 Months: Subjects With Aldosterone Breakthrough|
346006|NCT01129557|O7|Outcome|6 Months: Subjects With Aldosterone Breakthrough|
346007|NCT01129557|O6|Outcome|3 Months: Subjects With Aldosterone Breakthrough|
346008|NCT01129557|O5|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
346009|NCT01129557|O4|Outcome|9 Months: Subjects Without Aldosterone Breakthrough|
346010|NCT01129557|O3|Outcome|6 Months: Subjects Without Aldosterone Breakthrough|
346011|NCT01129557|O2|Outcome|3 Months: Subjects Without Aldosterone Breakthrough|
346012|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
346013|NCT01129557|O8|Outcome|9 Months: Subjects With Aldosterone Breakthrough|
346014|NCT01129557|O7|Outcome|6 Months: Subjects With Aldosterone Breakthrough|
346015|NCT01129557|O6|Outcome|3 Months: Subjects With Aldosterone Breakthrough|
346016|NCT01129557|O5|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
346017|NCT01129557|O4|Outcome|9 Months: Subjects Without Aldosterone Breakthrough|
346018|NCT01129557|O3|Outcome|6 Months: Subjects Without Aldosterone Breakthrough|
346019|NCT01129557|O2|Outcome|3 Months: Subjects Without Aldosterone Breakthrough|
346020|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
346021|NCT01129557|O8|Outcome|9 Months: Subjects With Aldosterone Breakthrough|
346022|NCT01129557|O7|Outcome|6 Months: Subjects With Aldosterone Breakthrough|
346023|NCT01129557|O6|Outcome|3 Months: Subjects With Aldosterone Breakthrough|
346024|NCT01129557|O5|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
346025|NCT01129557|O4|Outcome|9 Months: Subjects Without Aldosterone Breakthrough|
346026|NCT01129557|O3|Outcome|6 Months: Subjects Without Aldosterone Breakthrough|
346027|NCT01129557|O2|Outcome|3 Months: Subjects Without Aldosterone Breakthrough|
346028|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
346029|NCT01129557|O3|Outcome|Tekturna + Diovan|aliskiren + valsartan (DRI + ARB) : Tekturna 150 mg PO once daily + Diovan 160 mg PO once daily for 9 months
346030|NCT01129557|O2|Outcome|Tekturna|aliskiren [direct renin inhibitor (DRI)] : Tekturna 300 mg PO once daily for 9 months
346031|NCT01129557|O1|Outcome|Diovan|valsartan [angiotensin receptor blocker (ARB)] : Diovan 320 mg PO once daily for 9 months
346032|NCT01129557|E3|Reported Event|Tekturna + Diovan|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 150 mg by mouth once daily for 9 months & Diovan (Valsartan), an angiotensin receptor blocker (ARB) 160 mg by mouth once daily for 9 months
346033|NCT01129557|E2|Reported Event|Diovan|Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months
346034|NCT01129557|E1|Reported Event|Tekturna|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months
346035|NCT01129531|B4|Baseline|Total|Total of all reporting groups
346036|NCT01129531|B3|Baseline|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
346037|NCT01129531|B2|Baseline|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
346038|NCT01129531|B1|Baseline|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
346039|NCT01129531|P3|Participant Flow|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
346040|NCT01129531|P2|Participant Flow|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
346041|NCT01129531|P1|Participant Flow|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
346042|NCT01129531|O3|Outcome|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
346043|NCT01129531|O2|Outcome|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
346044|NCT01129531|O1|Outcome|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
346045|NCT01129531|O3|Outcome|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment. Participants received two treatments 12 weeks apart.
346496|NCT01128621|O5|Outcome|Sitagliptin 50 mg|Participant received 50 mg of Sitagliptin BID along with metformin for 14 days.
346046|NCT01129531|O2|Outcome|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
346047|NCT01129531|O1|Outcome|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
346048|NCT01129531|O3|Outcome|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
346049|NCT01129531|O2|Outcome|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
346050|NCT01129531|O1|Outcome|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
346051|NCT01129531|O3|Outcome|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
346052|NCT01129531|O2|Outcome|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
346053|NCT01129531|O1|Outcome|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
346054|NCT01129531|E6|Reported Event|Placebo_Cycle 2|One treatment of Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain.
346055|NCT01129531|E5|Reported Event|AGN-214868 16.25 μg_ Cycle 2|One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg.
346056|NCT01129531|E4|Reported Event|AGN-214868 3.25 μg_ Cycle 2|One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg.
346057|NCT01129531|E3|Reported Event|Placebo_Cycle 1|One treatment of Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain.
346058|NCT01129531|E2|Reported Event|AGN-214868 16.25 μg_Cycle 1|One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg.
346059|NCT01129531|E1|Reported Event|AGN-214868 3.25 μg_Cycle 1|One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg.
346060|NCT01129336|B3|Baseline|Total|Total of all reporting groups
346061|NCT01129336|B2|Baseline|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
346062|NCT01129336|B1|Baseline|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
346063|NCT01129336|P2|Participant Flow|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
346064|NCT01129336|P1|Participant Flow|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
346065|NCT01129336|O2|Outcome|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
346066|NCT01129336|O1|Outcome|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
346067|NCT01129336|O2|Outcome|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
346068|NCT01129336|O1|Outcome|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
346069|NCT01129336|O2|Outcome|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
346070|NCT01129336|O1|Outcome|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
346071|NCT01129336|O2|Outcome|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
346072|NCT01129336|O1|Outcome|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
346073|NCT01129336|E2|Reported Event|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
346074|NCT01129336|E1|Reported Event|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
346075|NCT01129284|B4|Baseline|Total|Total of all reporting groups
346076|NCT01129284|B3|Baseline|IgA Nephropathy|Subjects diagnosed with IgA nephropathy (Berger's disease)
346077|NCT01129284|B2|Baseline|FSGS/MCD|Subjects diagnosed with focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD)
346078|NCT01129284|B1|Baseline|Membranous Nephropathy|Subjects diagnosed with membranous nephropathy
346079|NCT01129284|P3|Participant Flow|Immunoglobulin A (IgA) Nephropathy|Subjects diagnosed with Immunoglobulin A (IgA) nephropathy (Berger's disease) were treated with ACTH gel (80 units subcutaneously twice a week) for 6 months.
346080|NCT01129284|P2|Participant Flow|FSGS/MCD|Subjects diagnosed with focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD) were treated with ACTH gel (80 units subcutaneously twice a week) for 6 months.
346081|NCT01129284|P1|Participant Flow|Membranous Nephropathy|Subjects diagnosed with membranous nephropathy were treated with ACTH gel (80 units subcutaneously twice a week) for 6 months.
346082|NCT01129284|O3|Outcome|IgA Nephropathy|Subjects diagnosed with IgA nephropathy (Berger's disease), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
346083|NCT01129284|O2|Outcome|FSGS/MCD|Subjects diagnosed with focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
350622|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
346084|NCT01129284|O1|Outcome|Membranous Nephropathy|Subjects diagnosed with membranous nephropathy, treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
346085|NCT01129284|O3|Outcome|IgA Nephropathy|Subjects diagnosed with IgA nephropathy (Berger's disease), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
346086|NCT01129284|O2|Outcome|FSGS/MCD|Subjects diagnosed with focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
346087|NCT01129284|O1|Outcome|Membranous Nephropathy|Subjects diagnosed with membranous nephropathy, treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
346088|NCT01129284|E3|Reported Event|IgA Nephropathy|Subjects diagnosed with IgA nephropathy (Berger's disease), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
346089|NCT01129284|E2|Reported Event|FSGS/MCD|Subjects diagnosed with focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
346090|NCT01129284|E1|Reported Event|Membranous Nephropathy|Subjects diagnosed with membranous nephropathy, treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
346091|NCT01129245|B3|Baseline|Total|Total of all reporting groups
346092|NCT01129245|B2|Baseline|Celecoxib First, Then Placebo|control menstrual cycle, celecoxib menstrual cycle, placebo menstrual cycle
346093|NCT01129245|B1|Baseline|Placebo First, Then Celecoxib|control menstrual cycle, placebo menstrual cycle, and then celecoxib menstrual cycle
346094|NCT01129245|P2|Participant Flow|Celecoxib First, Then Placebo|"receive celebrex based on hormone and ultrasound findings and timing of menstrual cycle~celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings~Placebo"
346095|NCT01129245|P1|Participant Flow|Placebo First, Then Celecoxib|"receive celebrex based on hormone and ultrasound findings and timing of menstrual cycle~celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings~Placebo"
346096|NCT01129245|O2|Outcome|Placebo|received placebo during menstrual cycle
346097|NCT01129245|O1|Outcome|Celebrex|"receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results~celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings"
346098|NCT01129245|E2|Reported Event|Placebo|received placebo drug
346099|NCT01129245|E1|Reported Event|Celebrex|"receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results~celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings"
346100|NCT01129206|B1|Baseline|Arm I|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.~docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.~fludeoxyglucose F 18: Correlative studies~positron emission tomography: Correlative studies"
346101|NCT01129206|P1|Participant Flow|Arm I: Pralatrexate and Docetaxel|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.~docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.~fludeoxyglucose F 18: Correlative studies~positron emission tomography: Correlative studies"
346102|NCT01129206|O2|Outcome|RECIST Criteria Per CT|
346103|NCT01129206|O1|Outcome|PERCIST Criteria Per PET|
346104|NCT01129206|O1|Outcome|Arm I|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.~docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.~fludeoxyglucose F 18: Correlative studies~positron emission tomography: Correlative studies"
346105|NCT01129206|O1|Outcome|Arm I: Pralatrexate and Docetaxel|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.~docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.~fludeoxyglucose F 18: Correlative studies~positron emission tomography: Correlative studies"
346106|NCT01129206|O1|Outcome|Arm I: Pralatrexate and Docetaxel|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.~docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.~fludeoxyglucose F 18: Correlative studies~positron emission tomography: Correlative studies"
346107|NCT01129206|E1|Reported Event|Arm I|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.~docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.~fludeoxyglucose F 18: Correlative studies~positron emission tomography: Correlative studies"
346108|NCT01129141|B3|Baseline|Total|Total of all reporting groups
346109|NCT01129141|B2|Baseline|Wait List Control|Wait List Control subjects received Tele-PTM after completing the 6-month questionnaires. Participants assigned to Wait List Control were instructed that they could receive any available tinnitus services, and that they would receive Tele-PTM following completion of the 3- and 6-month questionnaires.
346110|NCT01129141|B1|Baseline|Tele-PTM|Telephone-based Progressive Tinnitus Management (Tele-PTM) is a novel home-based telehealth program that involves a series of seven telephone appointments, conducted at approximately 1, 2, 3, 4, and 5 weeks, and 3 and 6 months after enrollment is finalized. Telephone education was provided by the Study Psychologist at weeks 1, 3, and 5, and month 6; and by the Study Audiologist at weeks 2 and 4, and month 3.
346173|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
350623|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
346111|NCT01129141|P2|Participant Flow|Wait List Control|Wait List Control subjects received Tele-PTM after completing the 6-month questionnaires. Participants assigned to Wait List Control were instructed that they could receive any available tinnitus services, and that they would receive Tele-PTM following completion of the 3- and 6-month questionnaires.
346112|NCT01129141|P1|Participant Flow|Tele-PTM|Telephone-based Progressive Tinnitus Management (Tele-PTM) is a novel home-based telehealth program that involves a series of seven telephone appointments, conducted at approximately 1, 2, 3, 4, and 5 weeks, and 3 and 6 months after enrollment is finalized. Telephone education was provided by the Study Psychologist at weeks 1, 3, and 5, and month 6; and by the Study Audiologist at weeks 2 and 4, and month 3.
346113|NCT01129141|O2|Outcome|Wait List Control|Wait List Control subjects received Tele-PTM after completing the 6-month questionnaires. Participants assigned to Wait List Control were instructed that they could receive any available tinnitus services, and that they would receive Tele-PTM following completion of the 3- and 6-month questionnaires.
346114|NCT01129141|O1|Outcome|Tele-PTM|Telephone-based Progressive Tinnitus Management (Tele-PTM) is a novel home-based telehealth program that involves a series of seven telephone appointments, conducted at approximately 1, 2, 3, 4, and 5 weeks, and 3 and 6 months after enrollment is finalized. Telephone education was provided by the Study Psychologist at weeks 1, 3, and 5, and month 6; and by the Study Audiologist at weeks 2 and 4, and month 3.
346115|NCT01129141|E2|Reported Event|Wait List Control|Wait List Control subjects received Tele-PTM after completing the 6-month questionnaires. Participants assigned to Wait List Control were instructed that they could receive any available tinnitus services, and that they would receive Tele-PTM following completion of the 3- and 6-month questionnaires.
346116|NCT01129141|E1|Reported Event|Tele-PTM|Telephone-based Progressive Tinnitus Management (Tele-PTM) is a novel home-based telehealth program that involves a series of seven telephone appointments, conducted at approximately 1, 2, 3, 4, and 5 weeks, and 3 and 6 months after enrollment is finalized. Telephone education was provided by the Study Psychologist at weeks 1, 3, and 5, and month 6; and by the Study Audiologist at weeks 2 and 4, and month 3.
346117|NCT01129128|B4|Baseline|Total|Total of all reporting groups
346118|NCT01129128|B3|Baseline|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
346119|NCT01129128|B2|Baseline|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
346120|NCT01129128|B1|Baseline|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
346121|NCT01129128|P3|Participant Flow|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
346122|NCT01129128|P2|Participant Flow|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
346123|NCT01129128|P1|Participant Flow|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
346124|NCT01129128|O3|Outcome|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
346125|NCT01129128|O2|Outcome|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
346126|NCT01129128|O1|Outcome|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
346127|NCT01129128|O3|Outcome|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
346128|NCT01129128|O2|Outcome|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
346129|NCT01129128|O1|Outcome|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
346130|NCT01129128|O3|Outcome|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
346131|NCT01129128|O2|Outcome|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
346132|NCT01129128|O1|Outcome|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
346133|NCT01129128|O3|Outcome|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
346134|NCT01129128|O2|Outcome|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
346135|NCT01129128|O1|Outcome|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
346136|NCT01129128|O3|Outcome|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
346137|NCT01129128|O2|Outcome|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
346138|NCT01129128|O1|Outcome|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
346139|NCT01129128|E3|Reported Event|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
346140|NCT01129128|E2|Reported Event|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
346141|NCT01129128|E1|Reported Event|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
346142|NCT01129115|B5|Baseline|Total|Total of all reporting groups
346143|NCT01129115|B4|Baseline|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
346144|NCT01129115|B3|Baseline|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
346145|NCT01129115|B2|Baseline|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
346222|NCT01128972|B1|Baseline|All Study Participants|All randomized participants were included for baseline evaluation.
346536|NCT01128621|O1|Outcome|Placebo|Participants received 3 tablets of matching placebo BID along with metformin for 14 days.
346146|NCT01129115|B1|Baseline|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
346147|NCT01129115|P4|Participant Flow|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
346148|NCT01129115|P3|Participant Flow|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
346149|NCT01129115|P2|Participant Flow|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
346150|NCT01129115|P1|Participant Flow|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
346151|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
346152|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
346153|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
346154|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
346155|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
346156|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
346157|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
346158|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
346159|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
346160|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
346161|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
346162|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
346163|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
346164|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
346165|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
346166|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
346167|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
346168|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
346169|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
346170|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
346171|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
346172|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
346174|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
346175|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
346176|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
346177|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
346178|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
346179|NCT01129115|E4|Reported Event|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
346180|NCT01129115|E3|Reported Event|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
346181|NCT01129115|E2|Reported Event|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
346182|NCT01129115|E1|Reported Event|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
346183|NCT01129102|B4|Baseline|Total|Total of all reporting groups
346184|NCT01129102|B3|Baseline|Placebo|Placebo for NPC-01
346185|NCT01129102|B2|Baseline|IKH-01|Norethisterone 1mg, Ethinyl estradiol 0.035mg
346186|NCT01129102|B1|Baseline|NPC-01|Norethisterone 1mg, Ethinyl estradiol 0.02mg
346187|NCT01129102|P3|Participant Flow|Placebo|"Placebo for NPC-01~Placebo: Placebo for NPC-01"
346188|NCT01129102|P2|Participant Flow|IKH-01|"Norethisterone 1mg, Ethinyl estradiol 0.035mg~IKH-01: Norethisterone 1mg, Ethinyl estradiol 0.035mg"
346189|NCT01129102|P1|Participant Flow|NPC-01|"Norethisterone 1mg, Ethinyl estradiol 0.02mg~NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg"
346190|NCT01129102|O2|Outcome|Placebo|"Placebo for NPC-01~Placebo: Placebo for NPC-01"
346191|NCT01129102|O1|Outcome|NPC-01|"Norethisterone 1mg, Ethinyl estradiol 0.02mg~NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg"
346192|NCT01129102|O2|Outcome|Placebo|"Placebo for NPC-01~Placebo: Placebo for NPC-01"
346193|NCT01129102|O1|Outcome|NPC-01|"Norethisterone 1mg, Ethinyl estradiol 0.02mg~NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg"
346194|NCT01129102|E3|Reported Event|Placebo|"Placebo for NPC-01~Placebo: Placebo for NPC-01"
346195|NCT01129102|E2|Reported Event|IKH-01|"Norethisterone 1mg, Ethinyl estradiol 0.035mg~IKH-01: Norethisterone 1mg, Ethinyl estradiol 0.035mg"
346196|NCT01129102|E1|Reported Event|NPC-01|"Norethisterone 1mg, Ethinyl estradiol 0.02mg~NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg"
346197|NCT01129011|B3|Baseline|Total|Total of all reporting groups
346198|NCT01129011|B2|Baseline|Naproxen|Naproxen 500 mg dosed twice daily (bid)
346199|NCT01129011|B1|Baseline|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
346200|NCT01129011|P2|Participant Flow|Naproxen|Naproxen 500 mg dosed twice daily (bid)
346201|NCT01129011|P1|Participant Flow|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
346202|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
346203|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
346204|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
346205|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
346206|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
346207|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
346208|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
346209|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
346210|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
346211|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
346212|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
346213|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
346214|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
346215|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
346216|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
346217|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
346218|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
346219|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
346220|NCT01129011|E2|Reported Event|Naproxen|Naproxen 500 mg dosed twice daily (bid)
346221|NCT01129011|E1|Reported Event|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
346223|NCT01128972|P5|Participant Flow|Placebo Dentifrice + Test MR|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and test MR containing NaF (450ppmF). The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
346224|NCT01128972|P4|Participant Flow|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
346225|NCT01128972|P3|Participant Flow|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference sodium monofluorophosphate (NaMFP)/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
346226|NCT01128972|P2|Participant Flow|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
346227|NCT01128972|P1|Participant Flow|Test Dentifrice + Test Mouth Rinse (MR)|Participants were administered with treatment regimen comprising of test sodium fluoride (NaF) dentifrice [containing 1450 parts per million (ppm) fluoride (F) as NaF and potassium nitrate (KNO3)] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5 gram (g) test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
346228|NCT01128972|O2|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
346229|NCT01128972|O1|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
346230|NCT01128972|O2|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
346231|NCT01128972|O1|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
346232|NCT01128972|O5|Outcome|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
346233|NCT01128972|O4|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
346234|NCT01128972|O3|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
346282|NCT01128894|B1|Baseline|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
346816|NCT01128049|E2|Reported Event|MGD Patient Population|Meibomium Gland Dysfunction population(intervention remains the same across all arms)
346235|NCT01128972|O2|Outcome|Test Dentifrice + Test MR|Participants were administered with treatment regimen comprising of test NaF dentifrice [containing 1450ppmF as NaF and KNO3] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
346236|NCT01128972|O1|Outcome|Placebo Dentifrice + Test MR|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and test MR containing NaF (450ppmF). The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
346237|NCT01128972|O5|Outcome|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
346238|NCT01128972|O4|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
346239|NCT01128972|O3|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
346240|NCT01128972|O2|Outcome|Test Dentifrice + Test MR|Participants were administered with treatment regimen comprising of test NaF dentifrice [containing 1450ppmF as NaF and KNO3] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
346241|NCT01128972|O1|Outcome|Placebo Dentifrice + Test MR|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and test MR containing NaF (450ppmF). The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
346242|NCT01128972|O4|Outcome|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
346243|NCT01128972|O3|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
346244|NCT01128972|O2|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
346245|NCT01128972|O1|Outcome|Test Dentifrice + Test MR|Participants were administered with treatment regimen comprising of test NaF dentifrice [containing 1450ppmF as NaF and KNO3] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
346246|NCT01128972|O4|Outcome|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
346247|NCT01128972|O3|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
346248|NCT01128972|O2|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
346249|NCT01128972|O1|Outcome|Test Dentifrice + Test MR|Participants were administered with treatment regimen comprising of test NaF dentifrice [containing 1450ppmF as NaF and KNO3] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
346250|NCT01128972|E5|Reported Event|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
346251|NCT01128972|E4|Reported Event|Placebo Dentifrice + Test MR|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and test MR containing NaF (450ppmF). The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
346252|NCT01128972|E3|Reported Event|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
346253|NCT01128972|E2|Reported Event|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
346254|NCT01128972|E1|Reported Event|Test Dentifrice + Test MR|Participants were administered with treatment regimen comprising of test NaF dentifrice [containing 1450ppmF as NaF and KNO3] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
346255|NCT01128959|B1|Baseline|Intravenous Carbamazepine (IV CBZ)|Intravenous Carbamazepine (IV CBZ): 10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.
346256|NCT01128959|P1|Participant Flow|Intravenous Carbamazepine (IV CBZ)|Intravenous Carbamazepine (IV CBZ): 10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.
346257|NCT01128959|O2|Outcome|Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion|Intravenous Carbamazepine (IV CBZ): 10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.
346258|NCT01128959|O1|Outcome|Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion|Intravenous Carbamazepine (IV CBZ): 10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.
346259|NCT01128959|E2|Reported Event|Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion|
346260|NCT01128959|E1|Reported Event|Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion|
346261|NCT01128946|B1|Baseline|Overall|All randomized participants
346262|NCT01128946|P4|Participant Flow|NaF Toothpaste (675ppmF|Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
346263|NCT01128946|P3|Participant Flow|Strontium Fluoride (SnF)/NaF Toothpaste (1450ppmF|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
346264|NCT01128946|P2|Participant Flow|Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF|Participants brushed their natural teeth twice daily, for one timed minute with 1.5g NaMFP and NaF toothpaste (1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures
346442|NCT01128621|O5|Outcome|Sitagliptin 50 mg|Participant received 50 mg of Sitagliptin BID along with metformin for 14 days.
350624|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
346265|NCT01128946|P1|Participant Flow|Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 gram (g) NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 milliliters (mL) water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
346266|NCT01128946|O4|Outcome|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
346267|NCT01128946|O3|Outcome|SnF/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
346268|NCT01128946|O2|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with 1.5g NaMFP and NaF toothpaste (1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
346269|NCT01128946|O1|Outcome|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
346270|NCT01128946|O4|Outcome|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
346271|NCT01128946|O3|Outcome|SnF/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
346272|NCT01128946|O2|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with 1.5g NaMFP and NaF toothpaste (1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
346273|NCT01128946|O1|Outcome|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
346274|NCT01128946|O2|Outcome|SnF/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
346275|NCT01128946|O1|Outcome|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
346276|NCT01128946|E4|Reported Event|SnF/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
346277|NCT01128946|E3|Reported Event|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with 1.5g NaMFP and NaF toothpaste (1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
346278|NCT01128946|E2|Reported Event|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
346279|NCT01128946|E1|Reported Event|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
346280|NCT01128894|B3|Baseline|Total|Total of all reporting groups
346281|NCT01128894|B2|Baseline|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
346283|NCT01128894|P2|Participant Flow|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
346284|NCT01128894|P1|Participant Flow|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
346285|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
346286|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
346287|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
346288|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
346289|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
346290|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
346291|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
346292|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
346293|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
346294|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
346295|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
346296|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
346297|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
346298|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
346299|NCT01128894|E2|Reported Event|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
346300|NCT01128894|E1|Reported Event|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
346301|NCT01128829|B1|Baseline|Obese Non Regular Users of Non Nutritive Sweeteners (NNS)|Obese subjects who do not use NNS and are “insulin-sensitive” (based on a Homeostasis Model Assessment of Insulin Resistance score <or =2.6).
346302|NCT01128829|P2|Participant Flow|"Sucralose Then Water"|"First intervention (1 day) subjects drank 60 ml of 2 mmolar sucralose10 min before drinking a 75 g glucose load.~Washout (~ 7 days) Second intervention (1 day) subjects drank 60 ml of water 10 min before drinking a 75 g glucose load."
346303|NCT01128829|P1|Participant Flow|"Water Then Sucralose"|"First intervention (1 day) subjects drank 60 ml of water 10 min before drinking a 75 g glucose load.~Washout (~ 7 days) Second intervention (1 day) subjects drank 60 ml of 2 mmolar sucralose 10 min before drinking a 75 g glucose load."
346304|NCT01128829|O1|Outcome|Obese Non Regular Users of Non Nutritive Sweeteners (NNS)|Obese subjects who do not use NNS and are “insulin-sensitive” (based on a Homeostasis Model Assessment of Insulin Resistance score <or =2.6).
346305|NCT01128829|E1|Reported Event|Obese Non Regular Users of Non Nutritive Sweeteners (NNS)|Obese subjects who do not use NNS and are “insulin-sensitive” (based on a Homeostasis Model Assessment of Insulin Resistance score <or =2.6).
346306|NCT01128738|B3|Baseline|Total|Total of all reporting groups
346307|NCT01128738|B2|Baseline|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346308|NCT01128738|B1|Baseline|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346443|NCT01128621|O4|Outcome|GSK1292263 600 mg|Participant received 3 tablet of 200 mg of GSK1292263 in the morning and 3 tablets of matching placebo in the evening along with metformin for 14 days.
346444|NCT01128621|O3|Outcome|GSK1292263 300 mg|Participant received 1 tablet of 200 mg, 1 tablet of 75 mg and 1 tablet of 25 mg (all GSK1292263) along with metformin BID for 14 days.
346309|NCT01128738|P2|Participant Flow|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346310|NCT01128738|P1|Participant Flow|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346311|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346312|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346313|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
346314|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346315|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346316|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
346317|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346318|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346319|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
346320|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346445|NCT01128621|O2|Outcome|GSK1292263 75 mg|Participant received 1 tablet of 75 mg of GSK1292263 and 2 tablets of matching placebo along with metformin BID for 14 days.
346446|NCT01128621|O1|Outcome|Placebo|Participants received 3 tablets of matching placebo BID along with metformin for 14 days.
346447|NCT01128621|O5|Outcome|Sitagliptin 50 mg|Participant received 50 mg of Sitagliptin BID along with metformin for 14 days.
350625|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
346321|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346322|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
346323|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346324|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346325|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
346326|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346327|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346328|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
346329|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346330|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346331|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
346332|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346333|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346334|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
346817|NCT01128049|E1|Reported Event|Normal Patient Population|Non-Dry Eye patient population (intervention remains the same across all arms)
346335|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346336|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346337|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
346338|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346339|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346340|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
346341|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346342|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346343|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
346344|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346345|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346346|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
346347|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346448|NCT01128621|O4|Outcome|GSK1292263 600 mg|Participant received 3 tablet of 200 mg of GSK1292263 in the morning and 3 tablets of matching placebo in the evening along with metformin for 14 days.
346449|NCT01128621|O3|Outcome|GSK1292263 300 mg|Participant received 1 tablet of 200 mg, 1 tablet of 75 mg and 1 tablet of 25 mg (all GSK1292263) along with metformin BID for 14 days.
346348|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346349|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
346350|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346351|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346352|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
346353|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346354|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346355|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
346356|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346357|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346358|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
346359|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346360|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346361|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
346906|NCT01127633|O1|Outcome|Placebo|Participants were from feeder studies (LZAM or LZAN).
346362|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346363|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346364|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
346365|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346366|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346367|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
346368|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346369|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346370|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
346371|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346372|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346373|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
346374|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346450|NCT01128621|O2|Outcome|GSK1292263 75 mg|Participant received 1 tablet of 75 mg of GSK1292263 and 2 tablets of matching placebo along with metformin BID for 14 days.
346451|NCT01128621|O1|Outcome|Placebo|Participants received 3 tablets of matching placebo BID along with metformin for 14 days.
346452|NCT01128621|O5|Outcome|Sitagliptin 50 mg|Participant received 50 mg of Sitagliptin BID along with metformin for 14 days.
346375|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346376|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
346377|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346378|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346379|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
346380|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346381|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346382|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346383|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346384|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346385|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346453|NCT01128621|O4|Outcome|GSK1292263 600 mg|Participant received 3 tablet of 200 mg of GSK1292263 in the morning and 3 tablets of matching placebo in the evening along with metformin for 14 days.
346454|NCT01128621|O3|Outcome|GSK1292263 300 mg|Participant received 1 tablet of 200 mg, 1 tablet of 75 mg and 1 tablet of 25 mg (all GSK1292263) along with metformin BID for 14 days.
346455|NCT01128621|O2|Outcome|GSK1292263 75 mg|Participant received 1 tablet of 75 mg of GSK1292263 and 2 tablets of matching placebo along with metformin BID for 14 days.
346386|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346387|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346388|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346389|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346390|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346391|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346392|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346393|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346394|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346395|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346456|NCT01128621|O1|Outcome|Placebo|Participants received 3 tablets of matching placebo BID along with metformin for 14 days.
350626|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
346396|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346397|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346398|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346399|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346400|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346401|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346402|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346403|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346404|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346405|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346457|NCT01128621|O5|Outcome|Sitagliptin 50 mg|Participant received 50 mg of Sitagliptin BID along with metformin for 14 days.
350627|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
346406|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346407|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346408|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346409|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346410|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346411|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346412|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346413|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346414|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346415|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346458|NCT01128621|O4|Outcome|GSK1292263 600 mg|Participant received 3 tablet of 200 mg of GSK1292263 in the morning and 3 tablets of matching placebo in the evening along with metformin for 14 days.
346416|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346417|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346418|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346419|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346420|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346421|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346422|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346423|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346424|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346425|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346459|NCT01128621|O3|Outcome|GSK1292263 300 mg|Participant received 1 tablet of 200 mg, 1 tablet of 75 mg and 1 tablet of 25 mg (all GSK1292263) along with metformin BID for 14 days.
346426|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346427|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346428|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346429|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346430|NCT01128738|E2|Reported Event|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346431|NCT01128738|E1|Reported Event|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
346432|NCT01128621|B3|Baseline|Total|Total of all reporting groups
346433|NCT01128621|B2|Baseline|Part B: GSK1292263 75 mg/300 mg/ 600 mg|Participants received one of three dosing regimens of GSK1292263: 75 mg twice daily (BID) (as 1 x 75 mg tablet GSK1292263 + 2 placebo tablets in morning and evening), 300 mg BID (as 1 x 200 mg tablet + 1 x 75 mg tablet + 1 x 25 mg tablet GSK1292263 in morning and evening) and 600 mg once daily (QD) (as 3 x 200 mg tablets GSK1292263 in morning + 3 x placebo tablets in evening) or matching placebo BID (as 3 x placebo tablets in morning and evening), or open-label sitagliptin 50 mg BID for 14 days. Seven days before enrollment in Part B, participants taking metformin three times daily (TID) or using an extended-release formulation were converted to the equivalent total daily dose of immediate release metformin administered BID.
346434|NCT01128621|B1|Baseline|Part A: GSK1292263 300 mg|Participants received a single dose of oral 300 mg tablet of GSK1292263 on Day 1 immediately after eating the breakfast meal. Participants also received their usual metformin monotherapy (>=1000 mg per day).
346435|NCT01128621|P2|Participant Flow|Part B: GSK1292263 75 mg/300 mg/ 600 mg|Participants received one of three dosing regimens of GSK1292263: 75 mg twice daily (BID) (as 1 x 75 mg tablet GSK1292263 + 2 placebo tablets in morning and evening), 300 mg BID (as 1 x 200 mg tablet + 1 x 75 mg tablet + 1 x 25 mg tablet GSK1292263 in morning and evening) and 600 mg once daily (QD) (as 3 x 200 mg tablets GSK1292263 in morning + 3 x placebo tablets in evening) or matching placebo BID (as 3 x placebo tablets in morning and evening), or open-label sitagliptin 50 mg BID for 14 days. Seven days before enrollment in Part B, participants taking metformin three times daily (TID) or using an extended-release formulation were converted to the equivalent total daily dose of immediate release metformin administered BID.
346436|NCT01128621|P1|Participant Flow|Part A: GSK1292263 300 mg|Participants received a single dose of oral 300 milligrams (mg) tablet of GSK1292263 on Day 1 immediately after eating the breakfast meal. Participants also received their usual metformin monotherapy (>=1000 mg per day).
346437|NCT01128621|O5|Outcome|Sitagliptin 50 mg|Participant received 50 mg of Sitagliptin BID along with metformin for 14 days.
346438|NCT01128621|O4|Outcome|GSK1292263 600 mg|Participant received 3 tablet of 200 mg of GSK1292263 in the morning and 3 tablets of matching placebo in the evening along with metformin for 14 days.
346439|NCT01128621|O3|Outcome|GSK1292263 300 mg|Participant received 1 tablet of 200 mg, 1 tablet of 75 mg and 1 tablet of 25 mg (all GSK1292263) along with metformin BID for 14 days.
346440|NCT01128621|O2|Outcome|GSK1292263 75 mg|Participant received 1 tablet of 75 mg of GSK1292263 and 2 tablets of matching placebo along with metformin BID for 14 days.
346441|NCT01128621|O1|Outcome|Placebo|Participants received 3 tablets of matching placebo BID along with metformin for 14 days.
346460|NCT01128621|O2|Outcome|GSK1292263 75 mg|Participant received 1 tablet of 75 mg of GSK1292263 and 2 tablets of matching placebo along with metformin BID for 14 days.
346461|NCT01128621|O1|Outcome|Placebo|Participants received 3 tablets of matching placebo BID along with metformin for 14 days.
346462|NCT01128621|O5|Outcome|Sitagliptin 50 mg|Participant received 50 mg of Sitagliptin BID along with metformin for 14 days.
346463|NCT01128621|O4|Outcome|GSK1292263 600 mg|Participant received 3 tablet of 200 mg of GSK1292263 in the morning and 3 tablets of matching placebo in the evening along with metformin for 14 days.
346464|NCT01128621|O3|Outcome|GSK1292263 300 mg|Participant received 1 tablet of 200 mg, 1 tablet of 75 mg and 1 tablet of 25 mg (all GSK1292263) along with metformin BID for 14 days.
346465|NCT01128621|O2|Outcome|GSK1292263 75 mg|Participant received 1 tablet of 75 mg of GSK1292263 and 2 tablets of matching placebo along with metformin BID for 14 days.
346466|NCT01128621|O1|Outcome|Placebo|Participants received 3 tablets of matching placebo BID along with metformin for 14 days.
346467|NCT01128621|O5|Outcome|Sitagliptin 50 mg|Participant received 50 mg of Sitagliptin BID along with metformin for 14 days.
346468|NCT01128621|O4|Outcome|GSK1292263 600 mg|Participant received 3 tablet of 200 mg of GSK1292263 in the morning and 3 tablets of matching placebo in the evening along with metformin for 14 days.
346469|NCT01128621|O3|Outcome|GSK1292263 300 mg|Participant received 1 tablet of 200 mg, 1 tablet of 75 mg and 1 tablet of 25 mg (all GSK1292263) along with metformin BID for 14 days.
346470|NCT01128621|O2|Outcome|GSK1292263 75 mg|Participant received 1 tablet of 75 mg of GSK1292263 and 2 tablets of matching placebo along with metformin BID for 14 days.
346471|NCT01128621|O1|Outcome|Placebo|Participants received 3 tablets of matching placebo BID along with metformin for 14 days.
346472|NCT01128621|O1|Outcome|Part A|Participants received a single dose of oral 300 mg tablet of GSK1292263 on Day 1 immediately after eating the breakfast meal. Participants also received their usual metformin monotherapy (>=1000 mg per day).
346473|NCT01128621|O1|Outcome|Part A|Participants received a single dose of oral 300 mg tablet of GSK1292263 on Day 1 immediately after eating the breakfast meal. Participants also received their usual metformin monotherapy (>=1000 mg per day).
346474|NCT01128621|O3|Outcome|GSK1292263 600 mg|Participant received 3 tablet of 200 mg of GSK1292263 in the morning and 3 tablets of matching placebo in the evening along with metformin for 14 days.
346475|NCT01128621|O2|Outcome|GSK1292263 300 mg|Participant received 1 tablet of 200 mg, 1 tablet of 75 mg and 1 tablet of 25 mg (all GSK1292263) along with metformin BID for 14 days.
346476|NCT01128621|O1|Outcome|GSK1292263 75 mg|Participant received 1 tablet of 75 mg of GSK1292263 and 2 tablets of matching placebo along with metformin BID for 14 days.
346477|NCT01128621|O3|Outcome|GSK1292263 600 mg|Participant received 3 tablet of 200 mg of GSK1292263 in the morning and 3 tablets of matching placebo in the evening along with metformin for 14 days.
346478|NCT01128621|O2|Outcome|GSK1292263 300 mg|Participant received 1 tablet of 200 mg, 1 tablet of 75 mg and 1 tablet of 25 mg (all GSK1292263) along with metformin BID for 14 days.
346479|NCT01128621|O1|Outcome|GSK1292263 75 mg|Participant received 1 tablet of 75 mg of GSK1292263 and 2 tablets of matching placebo along with metformin BID for 14 days.
346480|NCT01128621|O3|Outcome|GSK1292263 600 mg|Participant received 3 tablet of 200 mg of GSK1292263 in the morning and 3 tablets of matching placebo in the evening along with metformin for 14 days.
346481|NCT01128621|O2|Outcome|GSK1292263 300 mg|Participant received 1 tablet of 200 mg, 1 tablet of 75 mg and 1 tablet of 25 mg (all GSK1292263) along with metformin BID for 14 days.
346482|NCT01128621|O1|Outcome|GSK1292263 75 mg|Participant received 1 tablet of 75 mg of GSK1292263 and 2 tablets of matching placebo along with metformin BID for 14 days.
346483|NCT01128621|O3|Outcome|GSK1292263 600 mg|Participant received 3 tablet of 200 mg of GSK1292263 in the morning and 3 tablets of matching placebo in the evening along with metformin for 14 days.
346484|NCT01128621|O2|Outcome|GSK1292263 300 mg|Participant received 1 tablet of 200 mg, 1 tablet of 75 mg and 1 tablet of 25 mg (all GSK1292263) along with metformin BID for 14 days.
346485|NCT01128621|O1|Outcome|GSK1292263 75 mg|Participant received 1 tablet of 75 mg of GSK1292263 and 2 tablets of matching placebo along with metformin BID for 14 days.
346486|NCT01128621|O3|Outcome|GSK1292263 600 mg|Participant received 3 tablet of 200 mg of GSK1292263 in the morning and 3 tablets of matching placebo in the evening along with metformin for 14 days.
346487|NCT01128621|O2|Outcome|GSK1292263 300 mg|Participant received 1 tablet of 200 mg, 1 tablet of 75 mg and 1 tablet of 25 mg (all GSK1292263) along with metformin BID for 14 days.
346488|NCT01128621|O1|Outcome|GSK1292263 75 mg|Participant received 1 tablet of 75 mg of GSK1292263 and 2 tablets of matching placebo along with metformin BID for 14 days.
346489|NCT01128621|O1|Outcome|Part A|Participants received a single dose of oral 300 mg tablet of GSK1292263 on Day 1 immediately after eating the breakfast meal. Participants also received their usual metformin monotherapy (>=1000 mg per day).
346490|NCT01128621|O1|Outcome|Part A|Participants received a single dose of oral 300 mg tablet of GSK1292263 on Day 1 immediately after eating the breakfast meal. Participants also received their usual metformin monotherapy (>=1000 mg per day).
346491|NCT01128621|O1|Outcome|Part A|Participants received a single dose of oral 300 mg tablet of GSK1292263 on Day 1 immediately after eating the breakfast meal. Participants also received their usual metformin monotherapy (>=1000 mg per day).
346492|NCT01128621|O1|Outcome|Part A|Participants received a single dose of oral 300 mg tablet of GSK1292263 on Day 1 immediately after eating the breakfast meal. Participants also received their usual metformin monotherapy (>=1000 mg per day).
346493|NCT01128621|O1|Outcome|Part A|Participants received a single dose of oral 300 mg tablet of GSK1292263 on Day 1 immediately after eating the breakfast meal. Participants also received their usual metformin monotherapy (>=1000 mg per day).
346494|NCT01128621|O1|Outcome|Part A|Participants received a single dose of oral 300 mg tablet of GSK1292263 on Day 1 immediately after eating the breakfast meal. Participants also received their usual metformin monotherapy (>=1000 mg per day).
346495|NCT01128621|O1|Outcome|Part A|Participants received a single dose of oral 300 mg tablet of GSK1292263 on Day 1 immediately after eating the breakfast meal. Participants also received their usual metformin monotherapy (>=1000 mg per day).
346497|NCT01128621|O4|Outcome|GSK1292263 600 mg|Participant received 3 tablet of 200 mg of GSK1292263 in the morning and 3 tablets of matching placebo in the evening along with metformin for 14 days.
346498|NCT01128621|O3|Outcome|GSK1292263 300 mg|Participant received 1 tablet of 200 mg, 1 tablet of 75 mg and 1 tablet of 25 mg (all GSK1292263) along with metformin BID for 14 days.
346499|NCT01128621|O2|Outcome|GSK1292263 75 mg|Participant received 1 tablet of 75 mg of GSK1292263 and 2 tablets of matching placebo along with metformin BID for 14 days.
346500|NCT01128621|O1|Outcome|Placebo|Participants received 3 tablets of matching placebo BID along with metformin for 14 days.
346501|NCT01128621|O1|Outcome|Part A|Participants received a single dose of oral 300 mg tablet of GSK1292263 on Day 1 immediately after eating the breakfast meal. Participants also received their usual metformin monotherapy (>=1000 mg per day).
346502|NCT01128621|O5|Outcome|Sitagliptin 50 mg|Participant received 50 mg of Sitagliptin BID along with metformin for 14 days.
346503|NCT01128621|O4|Outcome|GSK1292263 600 mg|Participant received 3 tablet of 200 mg of GSK1292263 in the morning and 3 tablets of matching placebo in the evening along with metformin for 14 days.
346504|NCT01128621|O3|Outcome|GSK1292263 300 mg|Participant received 1 tablet of 200 mg, 1 tablet of 75 mg and 1 tablet of 25 mg (all GSK1292263) along with metformin BID for 14 days.
346505|NCT01128621|O2|Outcome|GSK1292263 75 mg|Participant received 1 tablet of 75 mg of GSK1292263 and 2 tablets of matching placebo along with metformin BID for 14 days.
346506|NCT01128621|O1|Outcome|Placebo|Participants received 3 tablets of matching placebo BID along with metformin for 14 days.
346507|NCT01128621|O1|Outcome|Part A|Participants received a single dose of oral 300 mg tablet of GSK1292263 on Day 1 immediately after eating the breakfast meal. Participants also received their usual metformin monotherapy (>=1000 mg per day).
346508|NCT01128621|O5|Outcome|Sitagliptin 50 mg|Participant received 50 mg of Sitagliptin BID along with metformin for 14 days.
346509|NCT01128621|O4|Outcome|GSK1292263 600 mg|Participant received 3 tablet of 200 mg of GSK1292263 in the morning and 3 tablets of matching placebo in the evening along with metformin for 14 days.
346510|NCT01128621|O3|Outcome|GSK1292263 300 mg|Participant received 1 tablet of 200 mg, 1 tablet of 75 mg and 1 tablet of 25 mg (all GSK1292263) along with metformin BID for 14 days.
346511|NCT01128621|O2|Outcome|GSK1292263 75 mg|Participant received 1 tablet of 75 mg of GSK1292263 and 2 tablets of matching placebo along with metformin BID for 14 days.
346512|NCT01128621|O1|Outcome|Placebo|Participants received 3 tablets of matching placebo BID along with metformin for 14 days.
346513|NCT01128621|O1|Outcome|Arm A|Participants received a single dose of oral 300 mg tablet of GSK1292263 on Day 1 immediately after eating the breakfast meal. Participants also received their usual metformin monotherapy (>=1000 mg per day).
346514|NCT01128621|O5|Outcome|Sitagliptin 50 mg|Participant received 50 mg of Sitagliptin BID along with metformin for 14 days.
346515|NCT01128621|O4|Outcome|GSK1292263 600 mg|Participant received 3 tablet of 200 mg of GSK1292263 in the morning and 3 tablets of matching placebo in the evening along with metformin for 14 days.
346516|NCT01128621|O3|Outcome|GSK1292263 300 mg|Participant received 1 tablet of 200 mg, 1 tablet of 75 mg and 1 tablet of 25 mg (all GSK1292263) along with metformin BID for 14 days.
346517|NCT01128621|O2|Outcome|GSK1292263 75 mg|Participant received 1 tablet of 75 mg of GSK1292263 and 2 tablets of matching placebo along with metformin BID for 14 days.
346518|NCT01128621|O1|Outcome|Placebo|Participants received 3 tablets of matching placebo BID along with metformin for 14 days.
346519|NCT01128621|O1|Outcome|Part A|Participants received a single dose of oral 300 mg tablet of GSK1292263 on Day 1 immediately after eating the breakfast meal. Participants also received their usual metformin monotherapy (>=1000 mg per day).
346520|NCT01128621|O5|Outcome|Sitagliptin 50 mg|Participant received 50 mg of Sitagliptin BID along with metformin for 14 days.
346521|NCT01128621|O4|Outcome|GSK1292263 600 mg|Participant received 3 tablet of 200 mg of GSK1292263 in the morning and 3 tablets of matching placebo in the evening along with metformin for 14 days.
346522|NCT01128621|O3|Outcome|GSK1292263 300 mg|Participant received 1 tablet of 200 mg, 1 tablet of 75 mg and 1 tablet of 25 mg (all GSK1292263) along with metformin BID for 14 days.
346523|NCT01128621|O2|Outcome|GSK1292263 75 mg|Participant received 1 tablet of 75 mg of GSK1292263 and 2 tablets of matching placebo along with metformin BID for 14 days.
346524|NCT01128621|O1|Outcome|Placebo|Participants received 3 tablets of matching placebo BID along with metformin for 14 days.
346525|NCT01128621|O1|Outcome|Arm A|Participants received a single dose of oral 300 mg tablet of GSK1292263 on Day 1 immediately after eating the breakfast meal. Participants also received their usual metformin monotherapy (>=1000 mg per day).
346526|NCT01128621|O5|Outcome|Sitagliptin 50 mg|Participant received 50 mg of Sitagliptin BID along with metformin for 14 days.
346527|NCT01128621|O4|Outcome|GSK1292263 600 mg|Participant received 3 tablet of 200 mg of GSK1292263 in the morning and 3 tablets of matching placebo in the evening along with metformin for 14 days.
346528|NCT01128621|O3|Outcome|GSK1292263 300 mg|Participant received 1 tablet of 200 mg, 1 tablet of 75 mg and 1 tablet of 25 mg (all GSK1292263) along with metformin BID for 14 days.
346529|NCT01128621|O2|Outcome|GSK1292263 75 mg|Participant received 1 tablet of 75 mg of GSK1292263 and 2 tablets of matching placebo along with metformin BID for 14 days.
346530|NCT01128621|O1|Outcome|Placebo|Participants received 3 tablets of matching placebo BID along with metformin for 14 days.
346531|NCT01128621|O1|Outcome|Part A|Participants received a single dose of oral 300 mg tablet of GSK1292263 on Day 1 immediately after eating the breakfast meal. Participants also received their usual metformin monotherapy (>=1000 mg per day).
346532|NCT01128621|O5|Outcome|Sitagliptin 50 mg|Participant received 50 mg of Sitagliptin BID along with metformin for 14 days.
346533|NCT01128621|O4|Outcome|GSK1292263 600 mg|Participant received 3 tablet of 200 mg of GSK1292263 in the morning and 3 tablets of matching placebo in the evening along with metformin for 14 days.
346534|NCT01128621|O3|Outcome|GSK1292263 300 mg|Participant received 1 tablet of 200 mg, 1 tablet of 75 mg and 1 tablet of 25 mg (all GSK1292263) along with metformin BID for 14 days.
346535|NCT01128621|O2|Outcome|GSK1292263 75 mg|Participant received 1 tablet of 75 mg of GSK1292263 and 2 tablets of matching placebo along with metformin BID for 14 days.
346537|NCT01128621|O1|Outcome|Part A|Participants received a single dose of oral 300 mg tablet of GSK1292263 on Day 1 immediately after eating the breakfast meal. Participants also received their usual metformin monotherapy (>=1000 mg per day).
346538|NCT01128621|O5|Outcome|Sitagliptin 50mg|Participant received 50 mg of Sitagliptin BID along with metformin for 14 days.
346539|NCT01128621|O4|Outcome|GSK1292263 600 mg|Participant received 3 tablet of 200 mg of GSK1292263 in the morning and 3 tablets of matching placebo in the evening along with metformin for 14 days.
346540|NCT01128621|O3|Outcome|GSK1292263 300 mg|Participant received 1 tablet of 200 mg, 1 tablet of 75 mg and 1 tablet of 25 mg (all GSK1292263) along with metformin BID for 14 days.
346541|NCT01128621|O2|Outcome|GSK1292263 75 mg|Participant received 1 tablet of 75 mg of GSK1292263 and 2 tablets of matching placebo along with metformin BID for 14 days.
346542|NCT01128621|O1|Outcome|Placebo|Participants received 3 tablets of matching placebo BID along with metformin for 14 days.
346543|NCT01128621|O1|Outcome|Part A|Participants received a single dose of oral 300 mg tablet of GSK1292263 on Day 1 immediately after eating the breakfast meal. Participants also received their usual metformin monotherapy (>=1000 mg per day).
346544|NCT01128621|O5|Outcome|Sitagliptin 50 mg|Participant received 50 mg of Sitagliptin BID along with metformin for 14 days.
346545|NCT01128621|O4|Outcome|GSK1292263 600 mg|Participant received 3 tablet of 200 mg of GSK1292263 in the morning and 3 tablets of matching placebo in the evening along with metformin for 14 days.
346546|NCT01128621|O3|Outcome|GSK1292263 300 mg|Participant received 1 tablet of 200 mg, 1 tablet of 75 mg and 1 tablet of 25 mg (all GSK1292263) along with metformin BID for 14 days
346547|NCT01128621|O2|Outcome|GSK1292263 75 mg|Participant received 1 tablet of 75 mg of GSK1292263 and 2 tablets of matching placebo along with metformin BID for 14 days
346548|NCT01128621|O1|Outcome|Placebo|Participants received 3 tablets of matching placebo BID along with metformin for 14 days
346549|NCT01128621|O1|Outcome|Part A|Participants received a single dose of oral 300 mg tablet of GSK1292263 on Day 1 immediately after eating the breakfast meal. Participants also received their usual metformin monotherapy (>=1000 mg per day).
346550|NCT01128621|E6|Reported Event|Sitagliptin 50 mg|Participant received 50 mg of Sitagliptin BID along with metformin for 14 days.
346551|NCT01128621|E5|Reported Event|GSK1292263 600 mg|Participant received 3 tablet of 200 mg of GSK1292263 in the morning and 3 tablets of matching placebo in the evening along with metformin for 14 days.
346552|NCT01128621|E4|Reported Event|Part B - GSK1292263 300 mg|Participant received 1 tablet of 200 mg, 1 tablet of 75 mg and 1 tablet of 25 mg (all GSK1292263) along with metformin BID for 14 days.
346553|NCT01128621|E3|Reported Event|Part B - GSK1292263 75 mg|Participant received 1 tablet of 75 mg of GSK1292263 and 2 tablets of matching placebo along with metformin BID for 14 days.
346554|NCT01128621|E2|Reported Event|Part B - Placebo|Participants received 3 tablets of matching placebo BID along with metformin for 14 days.
346555|NCT01128621|E1|Reported Event|Part A - GSK1292263 300 mg|Participants received a single dose of oral 300 mg tablet of GSK1292263 on Day 1 immediately after eating the breakfast meal. Participants also received their usual metformin monotherapy (>=1000 mg per day).
346556|NCT01128595|B1|Baseline|Placebo, FF/VI 100/25 µg OD, FF 100 µg OD, VI 25 µg|All participants received one of the following four treatments in one of four treatment periods once daily (OD) from the Dry Powder Inhaler (DPI) for 21 days: Placebo; Fluticasone Furoate /Vilanterol (FF/VI) 100/25 microgram (µg) dry inhalation powder; Fluticasone Furoate (FF) 100 µg dry inhalation powder; and Vilanterol (VI) 25 µg dry inhalation powder. Participants were randomized to receive treatment in one of the four following sequences: (1) VI 25 µg, Placebo, FF 100 µg, FF/VI 100/25 µg; (2) FF/VI 100/25 µg, FF 100 µg, Placebo, VI 25 µg; (3) Placebo, FF/VI 100/25 µg, VI 25 µg, FF 100 µg; (4) FF 100 µg, VI 25 µg, FF/VI 100/25 µg, Placebo. The four treatment periods were separated by a washout period of 21 to 35 days.
346557|NCT01128595|P4|Participant Flow|Sequence 4: FF 100 µg, VI 25 µg, FF/VI 100/25 µg, Placebo|Participants received FF 100 µg, VI 25 µg, FF/VI 100/25 µg, and placebo in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
346558|NCT01128595|P3|Participant Flow|Sequence 3: Placebo, FF/VI 100/25 µg, VI 25 µg, FF 100 µg|Participants received placebo, FF/VI 100/25 µg, VI 25 µg, and FF 100 µg in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
346559|NCT01128595|P2|Participant Flow|Sequence 2: FF/VI 100/25 µg, FF 100 µg, Placebo, VI 25 µg|Participants received FF/VI 100/25 µg, FF 100 µg, placebo, and VI 25 µg in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
346560|NCT01128595|P1|Participant Flow|Sequence 1: VI 25 µg, Placebo, FF 100 µg, FF/VI 100/25 µg|Participants received Vilanterol (VI) 25 micrograms (µg), placebo, fluticasone furoate (FF) 100 µg, and FF/VI 100/25 µg in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
346561|NCT01128595|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
346562|NCT01128595|O3|Outcome|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
346563|NCT01128595|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
346564|NCT01128595|O1|Outcome|Placebo|Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
346565|NCT01128595|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
347109|NCT01127256|P1|Participant Flow|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
346566|NCT01128595|O3|Outcome|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
346567|NCT01128595|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
346568|NCT01128595|O1|Outcome|Placebo|Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
346569|NCT01128595|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
346570|NCT01128595|O3|Outcome|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
346571|NCT01128595|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
346572|NCT01128595|O1|Outcome|Placebo|Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
346573|NCT01128595|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
346574|NCT01128595|O3|Outcome|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
346575|NCT01128595|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
346576|NCT01128595|O1|Outcome|Placebo|Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
346577|NCT01128595|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
346578|NCT01128595|O3|Outcome|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
346579|NCT01128595|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
346580|NCT01128595|O1|Outcome|Placebo|Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
346581|NCT01128595|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
346582|NCT01128595|O3|Outcome|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
346583|NCT01128595|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
346584|NCT01128595|O1|Outcome|Placebo|
346585|NCT01128595|E4|Reported Event|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
346586|NCT01128595|E3|Reported Event|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
346587|NCT01128595|E2|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
346588|NCT01128595|E1|Reported Event|Placebo|Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
346589|NCT01128569|B1|Baseline|Placebo, FF 100 µg OD, FF/VI 100/25 µg OD in 1 of 6 Sequences|All participants received one of the following three treatments in one of three treatment periods once daily (OD) in the evening from the Dry Powder Inhaler (DPI) for 28 days: Placebo, Fluticasone Furoate (FF) 100 microgram (µg) dry inhalation powder, and FF/Vilanterol (FF/VI) 100/25 µg dry inhalation powder. Participants were randomized to receive treatment in one of the six following sequences: (1) Placebo, FF 100 µg, FF/VI 100/25 µg; (2) Placebo, FF/VI 100/25 µg, FF 100 µg; (3) FF 100 µg, FF/VI 100/25 µg, Placebo; (4) FF 100 µg, Placebo, FF/VI 100/25 µg; (5) FF/VI 100/25 µg, Placebo, FF 100 µg; (6) FF/VI 100/25 µg, FF 100 µg, Placebo. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
346590|NCT01128569|P6|Participant Flow|Sequence 6: FF/VI 100/25 µg, FF 100 µg, Placebo|Participants received FF/VI 100/25 µg, FF 100 µg, and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
346591|NCT01128569|P5|Participant Flow|Sequence 5: FF/VI 100/25 µg, Placebo, FF 100 µg|Participants received FF/VI 100/25 µg, placebo, and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
346592|NCT01128569|P4|Participant Flow|Sequence 4: FF 100 µg, Placebo, FF/VI 100/25 µg|Participants received FF 100 µg, placebo, and FF/VI 100/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
346711|NCT01128270|O4|Outcome|Therapeutic Chloral Hydrate (2B)|Arm 2B: Subjects are given Chloral Hydrate (25 mg/kg for five nights)(25 mg/Kg.) Pharmacokinetics are done on days 1 and 5.
346593|NCT01128569|P3|Participant Flow|Sequence 3: FF 100 µg, FF/VI 100/25 µg, Placebo|Participants received FF 100 µg, FF/VI 100/25 µg, and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
346594|NCT01128569|P2|Participant Flow|Sequence 2: Placebo, FF/VI 100/25 µg, FF 100 µg|Participants received placebo, FF/VI 100/25 µg, and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
346595|NCT01128569|P1|Participant Flow|Sequence 1: Placebo, FF 100 µg, FF/VI 100/25 µg|Participants received placebo, Fluticasone Furoate (FF) 100 micrograms (µg), and FF/Vilanterol (VI) 100/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day (OD) in the evening from a Dry Powder Inhaler (DPI) for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
346596|NCT01128569|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
346597|NCT01128569|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
346598|NCT01128569|O1|Outcome|Placebo|Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
346599|NCT01128569|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
346600|NCT01128569|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
346601|NCT01128569|O1|Outcome|Placebo|Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
346602|NCT01128569|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
346603|NCT01128569|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
346604|NCT01128569|O1|Outcome|Placebo|Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
346605|NCT01128569|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
346606|NCT01128569|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
346607|NCT01128569|O1|Outcome|Placebo|Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
346608|NCT01128569|E3|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
346609|NCT01128569|E2|Reported Event|FF 100 µg OD|Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
346610|NCT01128569|E1|Reported Event|Placebo|Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
346611|NCT01128543|B1|Baseline|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
346612|NCT01128543|P1|Participant Flow|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
346613|NCT01128543|O1|Outcome|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
346614|NCT01128543|O1|Outcome|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
346615|NCT01128543|O1|Outcome|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
346616|NCT01128543|E1|Reported Event|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
347173|NCT01126801|E2|Reported Event|Placebo|Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.
346617|NCT01128426|B1|Baseline|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
346618|NCT01128426|P1|Participant Flow|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
346619|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
346620|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
346621|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
346622|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
346623|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
346624|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
346625|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 2 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
346626|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 2 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
346627|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 2 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
346628|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
346629|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
346630|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
346631|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
346632|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
346633|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
346634|NCT01128426|E1|Reported Event|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
346635|NCT01128413|B3|Baseline|Total|Total of all reporting groups
346636|NCT01128413|B2|Baseline|Routine Care (RC)|Patients randomized to receive routine ED care. IV fluid administration will be per the treating clinicians discretion.
346637|NCT01128413|B1|Baseline|Fluid Optimization (FO)|Cheetah NICOM® (non-invasive cardiac output monitoring) Passive Leg Raise Testing (PLRT) that demonstrates a >/= 15% change in stroke volume index (SVI) or cardiac index (CI) will receive a 500ml normal saline bolus. NICOM® PLRT with SVI or CI <15% will receive a saline lock.
346638|NCT01128413|P2|Participant Flow|Routine Care (RC)|Patients randomized to receive routine ED care. IV fluid administration will be per the treating clinicians discretion.
346639|NCT01128413|P1|Participant Flow|Fluid Optimization (FO)|Cheetah NICOM® (non-invasive cardiac output monitoring) Passive Leg Raise Testing (PLRT) that demonstrates a >/= 15% change in stroke volume index (SVI) or cardiac index (CI) will receive a 500ml normal saline bolus. NICOM® PLRT with SVI or CI <15% will receive a saline lock.
346640|NCT01128413|O2|Outcome|Routine Care (RC)|Patients randomized to receive routine ED care. IV fluid administration will be per the treating clinicians discretion.
346641|NCT01128413|O1|Outcome|Fluid Optimization (FO)|Cheetah NICOM® (non-invasive cardiac output monitoring) Passive Leg Raise Testing (PLRT) that demonstrates a >/= 15% change in stroke volume index (SVI) or cardiac index (CI) will receive a 500ml normal saline bolus. NICOM® PLRT with SVI or CI <15% will receive a saline lock.
346642|NCT01128413|E2|Reported Event|Routine Care (RC)|Patients randomized to receive routine ED care. IV fluid administration will be per the treating clinicians discretion.
346643|NCT01128413|E1|Reported Event|Fluid Optimization (FO)|Cheetah NICOM® (non-invasive cardiac output monitoring) Passive Leg Raise Testing (PLRT) that demonstrates a >/= 15% change in stroke volume index (SVI) or cardiac index (CI) will receive a 500ml normal saline bolus. NICOM® PLRT with SVI or CI <15% will receive a saline lock.
346644|NCT01128400|B4|Baseline|Total|Total of all reporting groups
346645|NCT01128400|B3|Baseline|rs1761667-AG Genotype|Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype.
346646|NCT01128400|B2|Baseline|rs1761667-GG Genotype|Obese subjects who are homozygous of CD36 genotype rs1761667-G allele.
346647|NCT01128400|B1|Baseline|rs1761667- AA Genotype|Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level
346648|NCT01128400|P3|Participant Flow|rs1761667-AG Genotype|Heterozygous of CD36 gene rs1761667-A genotype.
346649|NCT01128400|P2|Participant Flow|rs1761667-GG Genotype|subjects who are homozygous of CD36 genotype rs1761667-G allele.
346650|NCT01128400|P1|Participant Flow|rs1761667- AA Genotype|subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level and has a minor allele frequency of 38-48%.
346651|NCT01128400|O3|Outcome|rs1761667-AG Genotype|Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype.
346652|NCT01128400|O2|Outcome|rs1761667-GG Genotype|Obese subjects who are homozygous of CD36 genotype rs1761667-G allele.
346653|NCT01128400|O1|Outcome|rs1761667- AA Genotype|Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level
346654|NCT01128400|O3|Outcome|rs1761667-AG Genotype|Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype.
346655|NCT01128400|O2|Outcome|rs1761667-GG Genotype|Obese subjects who are homozygous of CD36 genotype rs1761667-G allele.
346656|NCT01128400|O1|Outcome|rs1761667- AA Genotype|Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level
346657|NCT01128400|E3|Reported Event|rs1761667-AG Genotype|Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype.
346658|NCT01128400|E2|Reported Event|rs1761667-GG Genotype|Obese subjects who are homozygous of CD36 genotype rs1761667-G allele.
346659|NCT01128400|E1|Reported Event|rs1761667- AA Genotype|Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level
346660|NCT01128387|B3|Baseline|Total|Total of all reporting groups
346661|NCT01128387|B2|Baseline|Dose Level -1|"Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.~1.5mg/kg Panitumumab, 60mg/m2 cisplatin, 750mg/m2 5FU"
346662|NCT01128387|B1|Baseline|Dose Level 1|"Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.~1.5mg/kg Panitumumab,80mg/m2 cisplatin, 1000mg/m2 5FU"
346663|NCT01128387|P2|Participant Flow|Dose Level -1|"Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.~1.5mg/kg Panitumumab,60mg/m2 cisplatin, 750mg/m2 5FU"
346664|NCT01128387|P1|Participant Flow|Dose Level 1|"Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.~1.5mg/kg Panitumumab,80mg/m2 cisplatin, 1000mg/m2 5FU (Fluorouracil)"
352905|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
346665|NCT01128387|O2|Outcome|Dose Level -1|"Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.~1.5mg/kg Panitumumab,60mg/m2 cisplatin, 750mg/m2 5FU"
346666|NCT01128387|O1|Outcome|Dose Level 1|"Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.~1.5mg/kg Panitumumab,80mg/m2 cisplatin, 1000mg/m2 5FU"
346667|NCT01128387|O2|Outcome|Dose Level -1|"Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.~1.5mg/kg Panitumumab,60mg/m2 cisplatin, 750mg/m2 5FU"
346668|NCT01128387|O1|Outcome|Dose Level 1|"Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.~1.5mg/kg Panitumumab,80mg/m2 cisplatin, 1000mg/m2 5FU"
346669|NCT01128387|E2|Reported Event|Dose Level -1|"Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.~1.5mg/kg Panitumumab,60mg/m2 cisplatin, 750mg/m2 5FU"
346670|NCT01128387|E1|Reported Event|Dose Level 1|"Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.~1.5mg/kg Panitumumab,80mg/m2 cisplatin, 1000mg/m2 5FU"
346671|NCT01128361|B3|Baseline|Total|Total of all reporting groups
346672|NCT01128361|B2|Baseline|Stretching|Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
346673|NCT01128361|B1|Baseline|Aerobic Exercise|Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
346674|NCT01128361|P2|Participant Flow|Stretching|Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
346675|NCT01128361|P1|Participant Flow|Aerobic Exercise|Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
346676|NCT01128361|O2|Outcome|Stretching|Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
346677|NCT01128361|O1|Outcome|Aerobic Exercise|Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
346688|NCT01128296|P5|Participant Flow|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1000 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1000 mg/day taken for 31 consecutive days until the day of surgery.
347174|NCT01126801|E1|Reported Event|Estradiol|Estradiol: Oral estradiol 1.0 mg/day for four weeks.
346678|NCT01128361|O2|Outcome|Stretching|Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
346679|NCT01128361|O1|Outcome|Aerobic Exercise|Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
346680|NCT01128361|O2|Outcome|Stretching|Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
346681|NCT01128361|O1|Outcome|Aerobic Exercise|Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
346682|NCT01128361|O2|Outcome|Stretching|Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
346683|NCT01128361|O1|Outcome|Aerobic Exercise|Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
346684|NCT01128361|E2|Reported Event|Stretching|Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
346685|NCT01128361|E1|Reported Event|Aerobic Exercise|Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
346686|NCT01128296|B1|Baseline|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ (maximum dose of 1200 mg/day) taken for 31 consecutive days until the day of surgery.
346687|NCT01128296|P6|Participant Flow|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1200 mg/day taken for 31 consecutive days until the day of surgery.
346689|NCT01128296|P4|Participant Flow|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (800 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 800 mg/day taken for 31 consecutive days until the day of surgery.
346690|NCT01128296|P3|Participant Flow|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (600 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 600 mg/day taken for 31 consecutive days until the day of surgery.
346691|NCT01128296|P2|Participant Flow|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (400 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 400 mg/day taken for 31 consecutive days until the day of surgery.
346692|NCT01128296|P1|Participant Flow|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 200 mg/day taken for 31 consecutive days until the day of surgery.
346693|NCT01128296|O1|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ (maximum dose of 1200 mg/day) taken for 31 consecutive days until the day of surgery.
346694|NCT01128296|O1|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ (maximum dose of 1200 mg/day) taken for 31 consecutive days until the day of surgery.
346695|NCT01128296|O1|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ (maximum dose of 1200 mg/day) taken for 31 consecutive days until the day of surgery.
346696|NCT01128296|O1|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ (maximum dose of 1200 mg/day) taken for 31 consecutive days until the day of surgery.
346697|NCT01128296|O1|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ (maximum dose of 1200 mg/day) taken for 31 consecutive days until the day of surgery.
346698|NCT01128296|O1|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ (maximum dose of 1200 mg/day) taken for 31 consecutive days until the day of surgery.
346699|NCT01128296|O1|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ (maximum dose of 1200 mg/day) taken for 31 consecutive days until the day of surgery.
346700|NCT01128296|O1|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ (maximum dose of 1200 mg/day) taken for 31 consecutive days until the day of surgery.
346701|NCT01128296|O1|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1200 mg/Day)|Participants with pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ (1200 mg/day) taken for 31 consecutive days until the day of surgery.
346702|NCT01128296|O6|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1200 mg/day taken for 31 consecutive days until the day of surgery.
346703|NCT01128296|O5|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1000 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1000 mg/day taken for 31 consecutive days until the day of surgery.
346704|NCT01128296|O4|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (800 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 800 mg/day taken for 31 consecutive days until the day of surgery.
346705|NCT01128296|O3|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (600 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 600 mg/day taken for 31 consecutive days until the day of surgery.
346706|NCT01128296|O2|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (400 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 400 mg/day taken for 31 consecutive days until the day of surgery.
346707|NCT01128296|O1|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 200 mg/day taken for 31 consecutive days until the day of surgery.
346708|NCT01128296|E1|Reported Event|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ (maximum dose of 1200 mg/day) taken for 31 consecutive days until the day of surgery.
346709|NCT01128270|B1|Baseline|All Subjects|Intent was to have all subjects participate in all sessions (periods)
346710|NCT01128270|P1|Participant Flow|All Subjects|The intent was to have all subjects participate in all four sessions (periods). These were environmental chloral hydrate +/- environmental DCA and therapeutic chloral hydrate +/- therapeutic DCA. Patient participation: 4 Sessions (N=2), 3 Sessions (N=1), 2 Sessions (N=6), 1 Session (N=8), 0 Sessions (N=10), Total: N=27 patients participated in 31 sessions.
346712|NCT01128270|O3|Outcome|Therapeutic Chloral Hydrate and DCA (2A)|Arm 2A: Subjects are given Chloral Hydrate (25 mg/kg for five nights) and therapeutic Dichloroacetate on Day 1 (25 mg/Kg.) Pharmacokinetics are done on days 1 and 5.
346713|NCT01128270|O2|Outcome|Environmental Chloral Hydrate (1B)|Arm 1B: Subjects are given Chloral Hydrate (1.5mcg/kg for five nights). Pharmacokinetics are done on days 1 and 5.
346714|NCT01128270|O1|Outcome|Environmental Chloral Hydrate and DCA (1A)|Arm 1A: Subjects are given Chloral Hydrate (1.5mcg/kg for five nights) and environmental Dichloroacetate on Day 1 (2.5 mcg/Kg.)pharmacokinetics are done on days 1 and 5.
346715|NCT01128270|O1|Outcome|Therapeutic Chloral Hydrate (2B)|Arm 2B: Subjects are given Chloral Hydrate (25 mg/kg for five nights)(25 mg/Kg.) Pharmacokinetics are done on days 1 and 5.
346716|NCT01128270|O1|Outcome|Therapeutic Chloral Hydrate (2B)|Arm 2B: Subjects are given Chloral Hydrate (25 mg/kg for five nights)(25 mg/Kg.) Pharmacokinetics are done on days 1 and 5.
346717|NCT01128270|O1|Outcome|Therapeutic Chloral Hydrate and DCA (2A)|Arm 2A: Subjects are given Chloral Hydrate (25 mg/kg for five nights) and therapeutic Dichloroacetate on Day 1 (25 mg/Kg.) Pharmacokinetics are done on days 1 and 5. This outcome only applies to Period 3.
346718|NCT01128270|E4|Reported Event|Chloral Hydrate (Therapeutic Dose)|This is Period 4 See description of periods for full details.
346719|NCT01128270|E3|Reported Event|Chloral Hydrate +DCA (Therapeutic Dose)|This is Period 3. See description of periods for full details.
346720|NCT01128270|E2|Reported Event|Chloral Hydrate (Environmental)|This is Period 2. See description of periods for full details.
346721|NCT01128270|E1|Reported Event|1A: Chloral Hydrate+DCA (Environmental)|This is Period 1. See description of periods for full details.
346722|NCT01128244|B1|Baseline|Vitamin B6 Effects in OC Users|"Subjects will be given an infusion of the amino acids, serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.~Vitamin B6: Subjects will receive vitamin B6 supplementation.~Infusion of amino acids, serine, methionine and leucine: Subjects will be given an infusion of the amino acids, serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of B6 treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic."
346723|NCT01128244|P1|Participant Flow|Vitamin B6 Effects in OC Users|"Subjects will be given an infusion of the amino acids serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.~Vitamin B6: Subjects will receive vitamin B6 supplementation.~Infusion of the amino acids, serine, methionine and leucine: Subjects will be given an infusion of the amino acids, serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of B6 treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic."
346724|NCT01128244|O1|Outcome|Secondary Analysis: Plasma 3-hydroxykynurenine Concentration|Plasma 3-hydroxykynurenine concentration will be measured for all subjects in fasting blood samples obtained at baseline and after 28 days of vitamin B6 supplementation. In addition, all subjects will have weekly weight, blood samples, and visits to the clinic to monitor compliance with the supplementation.
346725|NCT01128244|O1|Outcome|Plasma Cystathionine Concentration|Plasma cystathionine will be measured for all subjects in fasting blood samples obtained at baseline and after 28 days of vitamin B6 supplementation. In addition, all subjects will have weekly weight, blood samples, and visits to the clinic to monitor compliance with the supplementation.
346726|NCT01128244|O1|Outcome|Plasma Pyridoxal Phosphate Concentration|Plasma PLP will be measured for all subjects in fasting blood samples obtained at baseline and after 28 days of vitamin B6 supplementation. In addition, all subjects will have weekly weight, blood samples, and visits to the clinic to monitor compliance with the supplementation.
346727|NCT01128244|O1|Outcome|Homocysteine Remethylation Flux From Serine|All subjects will be given an infusion of the amino acids serine and methionine prior to vitamin B6 supplementation, and after 28-days of vitamin supplementation. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
346728|NCT01128244|O1|Outcome|Total Homocysteine Remethylation Flux|All subjects will be given an infusion of the amino acids serine and methionine prior to vitamin B6 supplementation, and after 28-days of vitamin supplementation. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
346729|NCT01128244|E1|Reported Event|Vitamin B6 Effects in OC Users|"Subjects will be given an infusion of the amino acids serine and methionine prior to vitamin B6 supplementation and after 28 days of treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.~Vitamin B6: Subjects will receive vitamin B6 supplementation.~Infusion of amino acids, serine, and methionine: Subjects will be given an infusion of the amino acids, serine, and methionine prior to vitamin B6 supplementation and after 28 days of B6 treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic."
346730|NCT01128192|B3|Baseline|Total|Total of all reporting groups
346731|NCT01128192|B2|Baseline|Pasireotide 900 μg sc Bid|Pasireotide 900 μg sc bid n=19
346732|NCT01128192|B1|Baseline|Pasireotide 600 μg sc Bid|Pasireotide 600 μg sc bid n=19
346733|NCT01128192|P3|Participant Flow|Pasireotide 1200 μg sc Bid|7 healthy male volunteers were randomized to receive Pasireotide 1200 μg (n=7). This arm was used in safety analysis only.
346734|NCT01128192|P2|Participant Flow|Pasireotide 900 μg sc Bid|19 healthy male volunteers were randomized to receive Pasireotide 900 μg (n=19). All participants completed the study.
346735|NCT01128192|P1|Participant Flow|Pasireotide 600 μg sc Bid|19 healthy male volunteers were randomized to receive Pasireotide 600 μg (n=19). All participants completed the study.
346736|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
346737|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
346738|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
346739|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
346740|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
346741|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
346742|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
346743|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
346744|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
346745|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
346746|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline hyperglycemic clamp test was conducted on Day 2 (pre-treatment) and a post-treatment hyperglycemic clamp was conducted on Day 9.
346747|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline hyperglycemic clamp test was conducted on Day 2 (pre-treatment) and a post-treatment hyperglycemic clamp was conducted on Day 9.
346748|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline hyperglycemic clamp test was conducted on Day 2 (pre-treatment) and a post-treatment hyperglycemic clamp was conducted on Day 9.
346749|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline hyperglycemic clamp test was conducted on Day 2 (pre-treatment) and a post-treatment hyperglycemic clamp was conducted on Day 9.
346750|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
346751|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
346752|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
346753|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
346754|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
346755|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
346756|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
346757|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
346758|NCT01128192|E3|Reported Event|Pasireotide 1200 μg sc Bid|Forty-five healthy male volunteers were randomized to receive pasireotide 600 μg (n=19), 900 μg (n=19) or 1200 μg (n=7) sc bid. All participants completed the study. Due to an increased severity of gastrointestinal AEs in the 1200 μg bid arm, randomization to this dose was discontinued after seven participants had completed the 7 days of treatment. These participants were included in the safety analyses only.
346759|NCT01128192|E2|Reported Event|Pasireotide 900 μg sc Bid|Forty-five healthy male volunteers were randomized to receive pasireotide 600 μg (n=19), 900 μg (n=19) or 1200 μg (n=7) sc bid. All participants completed the study. Due to an increased severity of gastrointestinal AEs in the 1200 μg bid arm, randomization to this dose was discontinued after seven participants had completed the 7 days of treatment. These participants were included in the safety analyses only.
346760|NCT01128192|E1|Reported Event|Pasireotide 600 μg sc Bid|Forty-five healthy male volunteers were randomized to receive pasireotide 600 μg (n=19), 900 μg (n=19) or 1200 μg (n=7) sc bid. All participants completed the study. Due to an increased severity of gastrointestinal AEs in the 1200 μg bid arm, randomization to this dose was discontinued after seven participants had completed the 7 days of treatment. These participants were included in the safety analyses only.
346761|NCT01128179|B3|Baseline|Total|Total of all reporting groups
346762|NCT01128179|B2|Baseline|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
346763|NCT01128179|B1|Baseline|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
346764|NCT01128179|P2|Participant Flow|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
346765|NCT01128179|P1|Participant Flow|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
346766|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
347175|NCT01126723|B3|Baseline|Total|Total of all reporting groups
346767|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
346768|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
346769|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
346770|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
346771|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
346772|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
346773|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
346774|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
346775|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
346776|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
346777|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
346778|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
346779|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
346780|NCT01128179|E2|Reported Event|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
346781|NCT01128179|E1|Reported Event|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
346782|NCT01128153|B3|Baseline|Total|Total of all reporting groups
346783|NCT01128153|B2|Baseline|PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
346784|NCT01128153|B1|Baseline|SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
346785|NCT01128153|P2|Participant Flow|PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
346786|NCT01128153|P1|Participant Flow|SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
346787|NCT01128153|O2|Outcome|Arm 2 - PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
346788|NCT01128153|O1|Outcome|Arm 1 - SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
346789|NCT01128153|O2|Outcome|Arm 2 - PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
346790|NCT01128153|O1|Outcome|Arm 1 - SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
346791|NCT01128153|O2|Outcome|Arm 2 - PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
346792|NCT01128153|O1|Outcome|Arm 1 - SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
346793|NCT01128153|O2|Outcome|Arm 2 - PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
346794|NCT01128153|O1|Outcome|Arm 1 - SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
346795|NCT01128153|O2|Outcome|Arm 2 - PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
346796|NCT01128153|O1|Outcome|Arm 1 - SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
346797|NCT01128153|O2|Outcome|Arm 2 - PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
346798|NCT01128153|O1|Outcome|Arm 1 - SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
346799|NCT01128153|E2|Reported Event|PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
346800|NCT01128153|E1|Reported Event|SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
346801|NCT01128114|B1|Baseline|Quetiapine XR|Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study
346802|NCT01128114|P1|Participant Flow|Quetiapine XR|Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study
346803|NCT01128114|O1|Outcome|Quetiapine XR|Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study
346804|NCT01128114|E1|Reported Event|Quetiapine XR|Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study
346805|NCT01128049|B4|Baseline|Total|Total of all reporting groups
346806|NCT01128049|B3|Baseline|ADDE Population|Subjects with schirmer’s value < 10mm/5 mins and no meibomian gland dysfunction.
346807|NCT01128049|B2|Baseline|MGD Patient Population|Subjects with a meibomian gland dysfunction on a slitlamp examination with a fluorescein tear break-up time <5 secs.
346808|NCT01128049|B1|Baseline|Normal Patient Population|Subjects with no symptoms and no diagnosis of dry eye. Schirmer’s value ≥ 10mm/5 mins and a fluorescein tear break-up time >5 secs with no surface staining.
346809|NCT01128049|P3|Participant Flow|ADDE Population|Subjects with schirmer’s value < 10mm/5 mins and no meibomian gland dysfunction.
346810|NCT01128049|P2|Participant Flow|MGD Patient Population|Subjects with a meibomian gland dysfunction on a slitlamp examination with a fluorescein tear break-up time <5 secs.
346811|NCT01128049|P1|Participant Flow|Normal Patient Population|Subjects with no symptoms and no diagnosis of dry eye. Schirmer’s value ≥ 10mm/5 mins and a fluorescein tear break-up time >5 secs with no surface staining.
346812|NCT01128049|O3|Outcome|Aqueous Deficiency Dry Eye (ADDE)|Subjects with a low tear volume measured by Schimer's score of less than 10 mm were included in this group.
346813|NCT01128049|O2|Outcome|Meibomian Gland Dysfunction (MGD)|Subjects with mild to moderate Meibomian Gland Dysfunction (MGD) on a slit lamp examination were included in this group.
346814|NCT01128049|O1|Outcome|Normal|Normal group included non-dry eye subjects.
346815|NCT01128049|E3|Reported Event|ADDE Population|Aqueous Deficient Dry Eye population(intervention remains the same across all arms)
346818|NCT01127763|B1|Baseline|RAD001+Carboplatin|Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.
346819|NCT01127763|P1|Participant Flow|RAD001+Carboplatin|Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.
346820|NCT01127763|O1|Outcome|RAD001+Carboplatin (All Patients)|Carboplatin every 3 weeks as IV infusion and RAD001 as 5 mg pill each day.
346821|NCT01127763|O1|Outcome|RAD001+Carboplatin|"Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.~RAD001~Carboplatin"
346822|NCT01127763|O3|Outcome|RAD001+Carboplatin (All Patients)|Carboplatin every 3 weeks as IV infusion and RAD001 as 5 mg pill each day.
346823|NCT01127763|O2|Outcome|RAD001+Carboplatin (AUC 4)|Carboplatin (starting dose of AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day.
346824|NCT01127763|O1|Outcome|RAD001+Carboplatin (AUC 6 and 5)|Carboplatin (starting dose of AUC 6 or AUC 5) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day.
346825|NCT01127763|O1|Outcome|RAD001+Carboplatin|"Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.~RAD001~Carboplatin"
346826|NCT01127763|E1|Reported Event|RAD001+Carboplatin|Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.
346827|NCT01127737|B3|Baseline|Total|Total of all reporting groups
346828|NCT01127737|B2|Baseline|Intervention|Educational intervention consisting of a mnemonic and a workbook used by kidney transplant recipients (KTRs) to assist with early detection of SCCs.
346829|NCT01127737|B1|Baseline|Control|Control group received only intiial assessment at the time of physician visit and education as usually provided during the physician visit.
346830|NCT01127737|P2|Participant Flow|Intervention|Educational intervention consisting of a mnemonic and a workbook used by kidney transplant recipients (KTRs) to assist with early detection of SCCs.
346831|NCT01127737|P1|Participant Flow|Control|Control group received only intiial assessment at the time of physician visit and education as usually provided during the physician visit.
346832|NCT01127737|O2|Outcome|Placebo|
346833|NCT01127737|O1|Outcome|Intervention|Educational intervention consisting of a mnemonic and a workboook
346834|NCT01127737|E2|Reported Event|Intervention|Educational intervention consisting of a mnemonic and a workbook used by kidney transplant recipients (KTRs) to assist with early detection of SCCs.
346835|NCT01127737|E1|Reported Event|Control|Control group received only intiial assessment at the time of physician visit and education as usually provided during the physician visit.
346836|NCT01127659|B7|Baseline|Total|Total of all reporting groups
346837|NCT01127659|B6|Baseline|Eugonadal Obese|obese non-diabetic men with normal testosterone
346838|NCT01127659|B5|Baseline|Eugonadal Diabetes|diabetic men with normal testosterone
346839|NCT01127659|B4|Baseline|Diabetes With HH: Placebo|"placebo diabetes hypogonadal arm~placebo: saline intramuscular every 2 weeks"
346840|NCT01127659|B3|Baseline|Obese With HH: Placebo|"placebo obese hypogonadal arm~placebo: saline intramuscular every 2 weeks"
346841|NCT01127659|B2|Baseline|Obese With HH: Testosterone|"active drug obese hypogonadal arm~testosterone: intramuscular every 2 weeks"
346842|NCT01127659|B1|Baseline|Diabetes With HH: Testosterone|"active drug diabetes hypogonadal arm~testosterone: intramuscular every 2 weeks"
346843|NCT01127659|P6|Participant Flow|Eugonadal Obese|no intervention
346844|NCT01127659|P5|Participant Flow|Eugonadal Diabetes|no intervention
346845|NCT01127659|P4|Participant Flow|Obese Placebo|"placebo obese arm~placebo: saline intramuscular every 2 weeks"
346846|NCT01127659|P3|Participant Flow|Obese Testosterone|"active drug obese arm~testosterone: intramuscular every 2 weeks"
346847|NCT01127659|P2|Participant Flow|Diabetes With HH: Placebo|"placebo diabetes arm~placebo: saline intramuscular every 2 weeks"
346848|NCT01127659|P1|Participant Flow|Diabetes With HH: Testosterone|"active drug diabetes arm~testosterone: intramuscular every 2 weeks"
346849|NCT01127659|O6|Outcome|Eugonadal Obese|obese non-diabetic men with normal testosterone
346850|NCT01127659|O5|Outcome|Eugonadal Diabetes|"diabetic men with normal testosterone~Glucose infusion rate: 10.29+/-5.55 mg/kg fat-free mass/min"
346851|NCT01127659|O4|Outcome|Obese With HH: Placebo|"placebo obese hypogonadal arm~placebo: saline intramuscular every 2 weeks"
346852|NCT01127659|O3|Outcome|Obese With HH: Testosterone|"active drug obese hypogonadal arm~testosterone: intramuscular every 2 weeks"
346853|NCT01127659|O2|Outcome|Diabetes With HH: Placebo|"placebo diabetes hypogonadal arm~placebo: saline intramuscular every 2 weeks"
346854|NCT01127659|O1|Outcome|Diabetes With HH: Testosterone|"active drug diabetes hypogonadal arm~testosterone: intramuscular every 2 weeks~Glucose infusion rate: 6.5+/-4.0 mg/kg fat-free mass/min"
346855|NCT01127659|E6|Reported Event|Eugonadal Obese|obese non-diabetic men with normal testosterone
346856|NCT01127659|E5|Reported Event|Eugonadal Diabetes|diabetic men with normal testosterone
346857|NCT01127659|E4|Reported Event|Obese With HH: Placebo|"placebo obese hypogonadal arm~placebo: saline intramuscular every 2 weeks"
346858|NCT01127659|E3|Reported Event|Obese With HH: Testosterone|"active drug obese hypogonadal arm~testosterone: intramuscular every 2 weeks"
346859|NCT01127659|E2|Reported Event|Diabetes With HH: Placebo|"placebo diabetes hypogonadal arm~placebo: saline intramuscular every 2 weeks"
346860|NCT01127659|E1|Reported Event|Diabetes With HH: Testosterone|"active drug diabetes hypogonadal arm~testosterone: intramuscular every 2 weeks"
346861|NCT01127646|B3|Baseline|Total|Total of all reporting groups
346862|NCT01127646|B2|Baseline|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
346863|NCT01127646|B1|Baseline|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
346864|NCT01127646|P2|Participant Flow|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
346865|NCT01127646|P1|Participant Flow|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
346866|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 1-5 days.
346867|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 25-80 mg of atomoxetine orally, once daily for 1-5 days.
346868|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 1-5 days.
346869|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 25-80 mg of atomoxetine orally, once daily for 1-5 days.
346870|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
346871|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
346872|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
346873|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
346874|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
346875|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
346876|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
346877|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
346878|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
346879|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
346880|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 1-5 days.
346907|NCT01127633|O2|Outcome|Solanezumab|400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
346908|NCT01127633|O1|Outcome|Placebo|Participants were from feeder studies (LZAM or LZAN).
346881|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 25-80 mg of atomoxetine orally, once daily for 1-5 days.
346882|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
346883|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
346884|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
346885|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
346886|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
346887|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
346888|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
346889|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
346890|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
346891|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
346892|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
346893|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
346894|NCT01127646|E2|Reported Event|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily during the run-in period for up to 7 days. The run-in period was followed by the 4-week on/off period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks, except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 1-5 days.
346895|NCT01127646|E1|Reported Event|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily during the run-in period for up to 7 days. The run-in period was followed by the 4-week on/off period in which participants received 25-80 mg of atomoxetine orally, once daily for 4 weeks, except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 25-80 mg of atomoxetine orally, once daily for 1-5 days.
346896|NCT01127633|B3|Baseline|Total|Total of all reporting groups
346897|NCT01127633|B2|Baseline|Solanezumab|400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
346898|NCT01127633|B1|Baseline|Placebo|Participants were from feeder studies (LZAM or LZAN).
346899|NCT01127633|P2|Participant Flow|Solanezumab|400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
346900|NCT01127633|P1|Participant Flow|Placebo|Participants were from feeder studies (LZAM or LZAN).
346901|NCT01127633|O2|Outcome|Solanezumab|400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
346902|NCT01127633|O1|Outcome|Placebo|Participants were from feeder studies (LZAM or LZAN).
346903|NCT01127633|O2|Outcome|Solanezumab|400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
346904|NCT01127633|O1|Outcome|Placebo|Participants were from feeder studies (LZAM or LZAN).
346905|NCT01127633|O2|Outcome|Solanezumab|400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
346909|NCT01127633|O2|Outcome|Solanezumab|400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
346910|NCT01127633|O1|Outcome|Placebo|Participants were from feeder studies (LZAM or LZAN).
346911|NCT01127633|O2|Outcome|Solanezumab|400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
346912|NCT01127633|O1|Outcome|Placebo|Participants were from feeder studies (LZAM or LZAN).
346913|NCT01127633|O2|Outcome|Solanezumab|400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
346914|NCT01127633|O1|Outcome|Placebo|Participants were from feeder studies (LZAM or LZAN).
346915|NCT01127633|O2|Outcome|Solanezumab|400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
346916|NCT01127633|O1|Outcome|Placebo|Participants were from feeder studies (LZAM or LZAN).
346917|NCT01127633|O2|Outcome|Solanezumab|400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
346918|NCT01127633|O1|Outcome|Placebo|Participants were from feeder studies (LZAM or LZAN).
346919|NCT01127633|O2|Outcome|Solanezumab|400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
346920|NCT01127633|O1|Outcome|Placebo|Participants were from feeder studies (LZAM or LZAN).
346921|NCT01127633|O2|Outcome|Solanezumab|400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
346922|NCT01127633|O1|Outcome|Placebo|Participants were from feeder studies (LZAM or LZAN).
346923|NCT01127633|O2|Outcome|Solanezumab|400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
346924|NCT01127633|O1|Outcome|Placebo|Participants were from feeder studies (LZAM or LZAN).
346925|NCT01127633|O2|Outcome|Solanezumab|400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
346926|NCT01127633|O1|Outcome|Placebo|Participants were from feeder studies (LZAM or LZAN).
346927|NCT01127633|E2|Reported Event|Solanezumab|400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
346928|NCT01127633|E1|Reported Event|Placebo|Participants were from feeder studies (LZAM or LZAN).
346929|NCT01127607|B3|Baseline|Total|Total of all reporting groups
346930|NCT01127607|B2|Baseline|Treatment Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded matching doses of lisdexamfetamine for 4 weeks of the parallel group trial.
346931|NCT01127607|B1|Baseline|Placebo Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded placebo for the 4 weeks of the parallel group trial
346932|NCT01127607|P2|Participant Flow|Treatment Arm|All 27 Participants were first optimized on lisdexamfetamine (LDX) (30mg, 50mg or 70mg) over 3 weeks then underwent within-subjects comparison with each subject completed one parent child interaction task (DPICS) once on optimal LDX dose and one parent child interaction task once on placebo (Period I). The 13 subjects assigned to this arm were then switched to blinded optimal dose of LDX for the parallel group, between subjects trial (period II) which lasted until the final endpoint assessment. These subjects received only their optimal dose of LDX during period II.
346933|NCT01127607|P1|Participant Flow|Placebo Arm|All 27 Participants were first optimized on lisdexamfetamine (LDX) (30mg, 50mg or 70mg) over 3 weeks then underwent within-subjects comparison with each subject completed one parent child interaction task (DPICS) once on optimal LDX dose and one parent child interaction task once on placebo (Period 1). The 14 subjects assigned to this arm were then switched to blinded placebo for the parallel group, between subjects trial (period II) which lasted until the final endpoint assessment. These subjects received only placebo during period II.
346934|NCT01127607|O2|Outcome|Optimal Dose of Medication|Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg)
346935|NCT01127607|O1|Outcome|Unmedicated|Data collected at intake, when participants were not on medication
346936|NCT01127607|O4|Outcome|70 mg Lisdexamfetamine|This group includes all participants who were prescribed the 70mg dose and completed at least one side effect rating for this dose. All participants reaching this dose were also treated with the 30mg and 50mg doses and are therefore included in those groups as well. Not all participants who were prescribed this dose were optimized to this dose.
346937|NCT01127607|O3|Outcome|50 mg Lisdexamfetamine|This group includes all participants who were prescribed the 50mg dose and completed at least one side effect rating for this dose. All participants reaching this dose were also treated with the 30mg dose and are therefore included in that group as well.Not all participants who were prescribed this dose were optimized to this dose or went on to enter the randomized phase of the study.
346938|NCT01127607|O2|Outcome|30 mg Lisdexamfetamine|This arm includes all participants who were prescribed the 30mg dose and completed at least one side effect rating for this dose.Not all participants who were prescribed this dose were optimized to this dose or went on to enter the randomized phase of the study which is why this cell size is larger than for the randomized controlled comparison that followed it.
346939|NCT01127607|O1|Outcome|No Medication|The PSERS was completed at intake by all 38 participants who consented and met eligibility criteria in order to assess pre-medication rates of side effects. This was done because the PSERS measures commonly occurring events such as insomnia and irritability that can be seen in unmedicated patients with ADHD.
346940|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
346941|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
346942|NCT01127607|O4|Outcome|Medication Non-academic Task|Parent-child interaction during a non-academic task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
346943|NCT01127607|O3|Outcome|Medication - Homework Task|Parent-child interaction during a homework task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
347102|NCT01127321|E3|Reported Event|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
346944|NCT01127607|O2|Outcome|Placebo - Non-academic Task|Parent-child interaction during a non-academic task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
346945|NCT01127607|O1|Outcome|Placebo - Homework Task|Parent-child interaction during a homework task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
346946|NCT01127607|O4|Outcome|Medication Non-academic Task|Parent-child interaction during a non-academic task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
346947|NCT01127607|O3|Outcome|Medication - Homework Task|Parent-child interaction during a homework task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
346948|NCT01127607|O2|Outcome|Placebo - Non-academic Task|Parent-child interaction during a non-academic task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
346949|NCT01127607|O1|Outcome|Placebo - Homework Task|Parent-child interaction during a homework task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
346950|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
346951|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
346952|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
346953|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
346954|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
346955|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
346956|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
346957|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
346958|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
346959|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
346960|NCT01127607|O2|Outcome|Treatment Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded matching doses of lisdexamfetamine for 4 weeks of the parallel group trial.
346961|NCT01127607|O1|Outcome|Placebo Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded placebo for the 4 weeks of the parallel group trial
346962|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
346963|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
346964|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
346965|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
346966|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
346967|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
346968|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
346969|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
346970|NCT01127607|O2|Outcome|Treatment Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded matching doses of lisdexamfetamine for 4 weeks of the parallel group trial.
346971|NCT01127607|O1|Outcome|Placebo Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded placebo for the 4 weeks of the parallel group trial
346972|NCT01127607|O2|Outcome|Treatment Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded matching doses of lisdexamfetamine for 4 weeks of the parallel group trial.
346973|NCT01127607|O1|Outcome|Placebo Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded placebo for the 4 weeks of the parallel group trial
346974|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
346975|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
346976|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
346977|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
346978|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
346979|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
346980|NCT01127607|O2|Outcome|Optimal Dose of Medication|Optimal dose of lisdexamfetamine (30 mg, 50 mg, or 70 mg) as selected by a three week open medication titration trial.
346981|NCT01127607|O1|Outcome|Unmedicated|baseline; participants not on medication
346982|NCT01127607|O4|Outcome|Medication Non-academic Task|Parent-child interaction during a non-academic task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
352906|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
346983|NCT01127607|O3|Outcome|Medication - Homework Task|Parent-child interaction during a homework task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
346984|NCT01127607|O2|Outcome|Placebo - Non-academic Task|Parent-child interaction during a non-academic task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
346985|NCT01127607|O1|Outcome|Placebo - Homework Task|Parent-child interaction during a homework task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
346986|NCT01127607|O4|Outcome|Medication Non-academic Task|Parent-child interaction during a non-academic task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
346987|NCT01127607|O3|Outcome|Medication - Homework Task|Parent-child interaction during a homework task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
346988|NCT01127607|O2|Outcome|Placebo - Non-academic Task|Parent-child interaction during a non-academic task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
346989|NCT01127607|O1|Outcome|Placebo - Homework Task|Parent-child interaction during a homework task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
346990|NCT01127607|O2|Outcome|Optimal Dose of Medication|Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg)
346991|NCT01127607|O1|Outcome|Unmedicated|Data collected at intake, when participants were not on medication
346992|NCT01127607|O2|Outcome|Optimal Dose of Medication|Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg)
346993|NCT01127607|O1|Outcome|Unmedicated|Data collected at intake, when participants were not on medication
346994|NCT01127607|O2|Outcome|Optimal Dose of Medication|Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg)
346995|NCT01127607|O1|Outcome|Unmedicated|Data collected at intake, when participants were not on medication
346996|NCT01127607|O2|Outcome|Optimal Dose of Medication|Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg)
346997|NCT01127607|O1|Outcome|Unmedicated|Data collected at intake, when participants were not on medication
346998|NCT01127607|E5|Reported Event|All Participants in Period 1 Prescribed 70mg|"During the dose optimization period which occurred before assignment to the placebo arm or treatment arm, all participants were treated with open label medication starting at 30mg of lisdexamfetamine (LDX). Dose was increased weekly (to a max of 70mg) until the optimal dose was defined. Once optimal dose criteria was met, the titration was stopped. Most participants received multiple doses so results for each dose are presented rather than for each participant.~17 of 36 participants were dispensed the 70mg dose."
346999|NCT01127607|E4|Reported Event|All Participants in Period 1 Prescribed 50mg|"During the dose optimization period which occurred before assignment to the placebo arm or treatment arm, all participants were treated with open label medication starting at 30mg of lisdexamfetamine (LDX). Dose was increased weekly (to a max of 70mg) until the optimal dose was defined. Once optimal dose criteria was met, the titration was stopped. Most participants received multiple doses so results for each dose are presented rather than for each participant.~21 of 36 participants were dispensed the 50mg dose."
347000|NCT01127607|E3|Reported Event|All Participants in Period 1 Prescribed 30mg|"During the dose optimization period which occurred before assignment to the placebo arm or treatment arm, all participants were treated with open label medication starting at 30mg of lisdexamfetamine (LDX). Dose was increased weekly (to a max of 70mg) until the optimal dose was defined. Once optimal dose criteria was met, the titration was stopped. Most participants received multiple doses so results for each dose are presented rather than for each participant.~All 36 participants who were dispensed the 30mg dose and completed at least one Pittsburgh Side Effect Rating Scale (PSERS) are included in this category."
347001|NCT01127607|E2|Reported Event|Treatment Arm|subjects in this arm (N=13) only treated with blinded optimal dose of LDX (either 30mg, 50mg or 70mg) for duration of assessment (period II between subjects trial).
347002|NCT01127607|E1|Reported Event|Placebo Arm|subjects in this arm treated only with blinded placebo for duration of assessment (period II- between subjects trial).One participant assigned to placebo dropped out before medication was dispensed for period II which is why the side effect data only has a total of 13 and not 14 subjects.
347003|NCT01127581|B3|Baseline|Total|Total of all reporting groups
347004|NCT01127581|B2|Baseline|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347005|NCT01127581|B1|Baseline|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347006|NCT01127581|P2|Participant Flow|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347103|NCT01127321|E2|Reported Event|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
347104|NCT01127321|E1|Reported Event|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
347007|NCT01127581|P1|Participant Flow|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347008|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347009|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347010|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347011|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347012|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347013|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347014|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347015|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347016|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347017|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347018|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347019|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347020|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347021|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347022|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347105|NCT01127256|B3|Baseline|Total|Total of all reporting groups
347106|NCT01127256|B2|Baseline|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
347023|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347024|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347025|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347026|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347027|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347028|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347029|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347030|NCT01127581|E2|Reported Event|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347031|NCT01127581|E1|Reported Event|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
347032|NCT01127503|B3|Baseline|Total|Total of all reporting groups
347033|NCT01127503|B2|Baseline|Placebo|Placebo: Placebo capsules were identically matched to Metyrosine.
347034|NCT01127503|B1|Baseline|Metyrosine|Metyrosine: Metyrosine (250 mg capsules) were to be used at all dose levels (administered as multiples of that dosing unit). The starting dose was 250 mg/day of metyrosine. Dose escalation was to be carried out weekly for 8 weeks (up to a maximum of 8 capsules/day [2000 mg/day if metyrosine]) with dosage increments of 1 capsule/day per week. Weekly dose escalation was to stop based upon the investigator’s assessment of safety, but not efficacy (i.e., dose escalation was to be forced to the maximum of 8 capsules/day assuming acceptable safety and tolerability).
347035|NCT01127503|P2|Participant Flow|Placebo|Placebo: Placebo capsules were identically matched to Metyrosine.
347036|NCT01127503|P1|Participant Flow|Metyrosine|Metyrosine: Metyrosine (250 mg capsules) were to be used at all dose levels (administered as multiples of that dosing unit). The starting dose was 250 mg/day of metyrosine. Dose escalation was to be carried out weekly for 8 weeks (up to a maximum of 8 capsules/day [2000 mg/day if metyrosine]) with dosage increments of 1 capsule/day per week. Weekly dose escalation was to stop based upon the investigator’s assessment of safety, but not efficacy (i.e., dose escalation was to be forced to the maximum of 8 capsules/day assuming acceptable safety and tolerability).
347037|NCT01127503|O2|Outcome|Placebo|Placebo: Placebo capsules were identically matched to Metyrosine.
347038|NCT01127503|O1|Outcome|Metyrosine|Metyrosine: Metyrosine (250 mg capsules) were to be used at all dose levels (administered as multiples of that dosing unit). The starting dose was 250 mg/day of metyrosine. Dose escalation was to be carried out weekly for 8 weeks (up to a maximum of 8 capsules/day [2000 mg/day if metyrosine]) with dosage increments of 1 capsule/day per week. Weekly dose escalation was to stop based upon the investigator’s assessment of safety, but not efficacy (i.e., dose escalation was to be forced to the maximum of 8 capsules/day assuming acceptable safety and tolerability).
347039|NCT01127503|E2|Reported Event|Placebo|Placebo: Placebo capsules were identically matched to Metyrosine.
347040|NCT01127503|E1|Reported Event|Metyrosine|Metyrosine: Metyrosine (250 mg capsules) were to be used at all dose levels (administered as multiples of that dosing unit). The starting dose was 250 mg/day of metyrosine. Dose escalation was to be carried out weekly for 8 weeks (up to a maximum of 8 capsules/day [2000 mg/day if metyrosine]) with dosage increments of 1 capsule/day per week. Weekly dose escalation was to stop based upon the investigator’s assessment of safety, but not efficacy (i.e., dose escalation was to be forced to the maximum of 8 capsules/day assuming acceptable safety and tolerability).
347041|NCT01127438|B7|Baseline|Total|Total of all reporting groups
347042|NCT01127438|B6|Baseline|Subgroup 3, Approved Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
347043|NCT01127438|B5|Baseline|Subgroup 3, Lower Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 3.9mg of Lusedra per kg during the Randomizatio n Phase (1 day).
347044|NCT01127438|B4|Baseline|Subgroup 2, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomizatio n Phase (1 day).
347045|NCT01127438|B3|Baseline|Subgroup 2, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
347046|NCT01127438|B2|Baseline|Subgroup 1, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. A dose of 385mg of Lusedra was taken during the Randomizatio n Phase (1 day).
347047|NCT01127438|B1|Baseline|Subgroup 1, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. The doses were weightadjusted for each subject, with 6.5mg of Lusedra per kg during the Randomizatio n Phase (1 day).
347048|NCT01127438|P6|Participant Flow|Subgroup 3, Approved Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiologists (ASA) physical classification status 3 or 4. The doses were weight adjusted for each subject, with 4.875mg of Lusedra per kg during the Randomization Phase (1 day).
347049|NCT01127438|P5|Participant Flow|Subgroup 3, Lower Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiologists (ASA) physical classification status 3 or 4. The doses were weight-adjusted for each subject, with 3.9mg of Lusedra per kg during the Randomization Phase (1 day).
347050|NCT01127438|P4|Participant Flow|Subgroup 2, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiologists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomization Phase (1 day).
347051|NCT01127438|P3|Participant Flow|Subgroup 2, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiologists (ASA) physical classification status 3 or 4. The doses were weight-adjusted for each subject, with 4.875mg of Lusedra per kg during the Randomization Phase (1 day).
347052|NCT01127438|P2|Participant Flow|Subgroup 1, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiologists (ASA) physical classification status 1 or 2. A dose of 385mg of Lusedra was taken during the Randomization Phase (1 day).
347053|NCT01127438|P1|Participant Flow|Subgroup 1, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiologists (ASA) physical classification status 1 or 2. The doses were weight-adjusted for each subject, with 6.5mg of Lusedra per kg during the Randomization Phase (1 day).
347054|NCT01127438|O6|Outcome|Subgroup 3, Approved Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
347055|NCT01127438|O5|Outcome|Subgroup 3, Lower Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 3.9mg of Lusedra per kg during the Randomizatio n Phase (1 day).
347056|NCT01127438|O4|Outcome|Subgroup 2, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomizatio n Phase (1 day).
347057|NCT01127438|O3|Outcome|Subgroup 2, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
347058|NCT01127438|O2|Outcome|Subgroup 1, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. A dose of 385mg of Lusedra was taken during the Randomizatio n Phase (1 day).
347059|NCT01127438|O1|Outcome|Subgroup 1, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. The doses were weightadjusted for each subject, with 6.5mg of Lusedra per kg during the Randomizatio n Phase (1 day).
347060|NCT01127438|O6|Outcome|Subgroup 3, Approved Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
347061|NCT01127438|O5|Outcome|Subgroup 3, Lower Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 3.9mg of Lusedra per kg during the Randomizatio n Phase (1 day).
347062|NCT01127438|O4|Outcome|Subgroup 2, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomizatio n Phase (1 day).
347107|NCT01127256|B1|Baseline|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
347108|NCT01127256|P2|Participant Flow|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
347063|NCT01127438|O3|Outcome|Subgroup 2, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
347064|NCT01127438|O2|Outcome|Subgroup 1, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. A dose of 385mg of Lusedra was taken during the Randomizatio n Phase (1 day).
347065|NCT01127438|O1|Outcome|Subgroup 1, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. The doses were weightadjusted for each subject, with 6.5mg of Lusedra per kg during the Randomizatio n Phase (1 day).
347066|NCT01127438|O6|Outcome|Subgroup 3, Approved Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
347067|NCT01127438|O5|Outcome|Subgroup 3, Lower Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 3.9mg of Lusedra per kg during the Randomizatio n Phase (1 day).
347068|NCT01127438|O4|Outcome|Subgroup 2, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomizatio n Phase (1 day).
347069|NCT01127438|O3|Outcome|Subgroup 2, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
347070|NCT01127438|O2|Outcome|Subgroup 1, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. A dose of 385mg of Lusedra was taken during the Randomizatio n Phase (1 day).
347071|NCT01127438|O1|Outcome|Subgroup 1, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. The doses were weightadjusted for each subject, with 6.5mg of Lusedra per kg during the Randomizatio n Phase (1 day).
347072|NCT01127438|E2|Reported Event|Approved Dose|Includes subgroups 1-3
347073|NCT01127438|E1|Reported Event|Lower Dose|Includes subgroups 1-3
347074|NCT01127321|B6|Baseline|Total|Total of all reporting groups
347075|NCT01127321|B5|Baseline|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
347076|NCT01127321|B4|Baseline|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
347077|NCT01127321|B3|Baseline|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
347078|NCT01127321|B2|Baseline|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
347079|NCT01127321|B1|Baseline|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
347080|NCT01127321|P5|Participant Flow|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
347081|NCT01127321|P4|Participant Flow|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
347082|NCT01127321|P3|Participant Flow|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
347083|NCT01127321|P2|Participant Flow|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
347084|NCT01127321|P1|Participant Flow|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
347085|NCT01127321|O5|Outcome|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
347086|NCT01127321|O4|Outcome|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
347087|NCT01127321|O3|Outcome|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
347088|NCT01127321|O2|Outcome|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
347089|NCT01127321|O1|Outcome|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
347090|NCT01127321|O5|Outcome|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
347091|NCT01127321|O4|Outcome|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
347092|NCT01127321|O3|Outcome|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
347093|NCT01127321|O2|Outcome|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
347094|NCT01127321|O1|Outcome|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
347095|NCT01127321|O5|Outcome|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
347096|NCT01127321|O4|Outcome|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
347097|NCT01127321|O3|Outcome|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
347098|NCT01127321|O2|Outcome|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
347099|NCT01127321|O1|Outcome|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
347100|NCT01127321|E5|Reported Event|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
347101|NCT01127321|E4|Reported Event|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
352907|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
347110|NCT01127256|O2|Outcome|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
347111|NCT01127256|O1|Outcome|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
347112|NCT01127256|O2|Outcome|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
347113|NCT01127256|O1|Outcome|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
347114|NCT01127256|O2|Outcome|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
347115|NCT01127256|O1|Outcome|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
347116|NCT01127256|E2|Reported Event|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
347117|NCT01127256|E1|Reported Event|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
347118|NCT01127165|B3|Baseline|Total|Total of all reporting groups
347119|NCT01127165|B2|Baseline|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
347120|NCT01127165|B1|Baseline|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
347121|NCT01127165|P2|Participant Flow|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
347122|NCT01127165|P1|Participant Flow|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
347123|NCT01127165|O2|Outcome|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
347124|NCT01127165|O1|Outcome|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
347125|NCT01127165|O2|Outcome|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
347126|NCT01127165|O1|Outcome|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
347127|NCT01127165|O2|Outcome|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
347128|NCT01127165|O1|Outcome|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
347129|NCT01127165|O2|Outcome|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
347130|NCT01127165|O1|Outcome|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
347131|NCT01127165|E2|Reported Event|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
347132|NCT01127165|E1|Reported Event|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
347133|NCT01127139|B1|Baseline|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
347134|NCT01127139|P1|Participant Flow|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
347135|NCT01127139|O1|Outcome|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
347136|NCT01127139|O1|Outcome|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
347137|NCT01127139|O3|Outcome|Male Participants|Male Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
347138|NCT01127139|O2|Outcome|Female Participants|Female Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
347139|NCT01127139|O1|Outcome|Total|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
347140|NCT01127139|O1|Outcome|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
347141|NCT01127139|O1|Outcome|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
347142|NCT01127139|O1|Outcome|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
347143|NCT01127139|O1|Outcome|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
347144|NCT01127139|O3|Outcome|Male Participants|Male Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
347145|NCT01127139|O2|Outcome|Female Participants|Female Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
347146|NCT01127139|O1|Outcome|Total|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
347147|NCT01127139|E1|Reported Event|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
347148|NCT01127087|B3|Baseline|Total|Total of all reporting groups
347250|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347149|NCT01127087|B2|Baseline|Idiopathic Hyperoxaluria CaOx Stone Formers|"Subjects with idiopathic hyperoxaluria.~Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
347150|NCT01127087|B1|Baseline|RYGB CaOx Stone Formers|"Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).~Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
347151|NCT01127087|P2|Participant Flow|Idiopathic Hyperoxaluria CaOx Stone Formers|"Subjects with idiopathic hyperoxaluria.~Dosing: 1gm Oxazyme containing approximately 1600 Units oxalate decarboxylase (OxDC) in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
347152|NCT01127087|P1|Participant Flow|RYGB CaOx Stone Formers|"Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).~Dosing: 1gm Oxazyme containing approximately 1600 Units oxalate decarboxylase (OxDC) in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
347153|NCT01127087|O2|Outcome|Idiopathic Hyperoxaluria CaOx Stone Formers|"Subjects with idiopathic hyperoxaluria.~Dosing: 1gm Oxazyme containing approximately 1600 Units oxalate decarboxylase (OxDC) in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
347154|NCT01127087|O1|Outcome|RYGB CaOx Stone Formers|"Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).~Dosing: 1gm Oxazyme containing approximately 1600 Units oxalate decarboxylase (OxDC) in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
347155|NCT01127087|O2|Outcome|Idiopathic Hyperoxaluria CaOx Stone Formers|"Subjects with idiopathic hyperoxaluria.~Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
347156|NCT01127087|O1|Outcome|RYGB CaOx Stone Formers|"Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).~Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
347157|NCT01127087|E2|Reported Event|Idiopathic Hyperoxaluria CaOx Stone Formers|"Subjects with idiopathic hyperoxaluria.~Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
347158|NCT01127087|E1|Reported Event|RYGB CaOx Stone Formers|"Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).~Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
347159|NCT01126957|B1|Baseline|Ketamine or Placebo|"Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion or placebo, followed by propofol to maintain sedation.~Ketamine: Ketamine was given as a 0.5mg / Kg bolus.~Fentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo~Propofol: Propofol given to both arms to maintain sedation throughout procedure."
347160|NCT01126957|P1|Participant Flow|Ketamine or Placebo|"Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine or placebo infusion, followed by propofol to maintain sedation.~Ketamine: Ketamine was given as a 0.5mg / Kg bolus.~Fentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo~Propofol: Propofol given to both arms to maintain sedation throughout procedure."
347161|NCT01126957|O1|Outcome|Ketamine|"Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion or placebo, followed by propofol to maintain sedation.~Ketamine: Ketamine was given as a 0.5mg / Kg bolus.~Fentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo~Propofol: Propofol given to both arms to maintain sedation throughout procedure."
347162|NCT01126957|O1|Outcome|Ketamine or Placebo|"Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion or placebo, followed by propofol to maintain sedation.~Ketamine: Ketamine was given as a 0.5mg / Kg bolus.~Fentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo~Propofol: Propofol given to both arms to maintain sedation throughout procedure."
347163|NCT01126957|E1|Reported Event|Ketamine or Placebo|"Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion or palcebo, followed by propofol to maintain sedation.~Ketamine: Ketamine was given as a 0.5mg / Kg bolus.~Fentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo~Propofol: Propofol given to both arms to maintain sedation throughout procedure."
347164|NCT01126801|B3|Baseline|Total|Total of all reporting groups
347165|NCT01126801|B2|Baseline|Placebo|Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.
347166|NCT01126801|B1|Baseline|Estradiol|Estradiol: Oral estradiol 1.0 mg/day for four weeks.
347167|NCT01126801|P2|Participant Flow|Placebo|Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.
347168|NCT01126801|P1|Participant Flow|Estradiol|Estradiol: Oral estradiol 1.0 mg/day for four weeks.
347169|NCT01126801|O2|Outcome|Placebo|Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.
347170|NCT01126801|O1|Outcome|Estradiol|Estradiol: Oral estradiol 1.0 mg/day for four weeks.
347171|NCT01126801|O2|Outcome|Placebo|Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.
347172|NCT01126801|O1|Outcome|Estradiol|Estradiol: Oral estradiol 1.0 mg/day for four weeks.
347176|NCT01126723|B2|Baseline|Educational Control Group|Education-Control: The Education-Control intervention consists of a 12 week, instructor-led attention control program consisting of health education and mind-body breathing exercises (two, one-hour sessions per week)
347177|NCT01126723|B1|Baseline|Tai Chi Group|Tai Chi: The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).
347178|NCT01126723|P2|Participant Flow|Educational Control Group|Education-Control: The Education-Control intervention consists of a 12 week, instructor-led attention control program consisting of health education and mind-body breathing exercises (two, one-hour sessions per week)
347179|NCT01126723|P1|Participant Flow|Tai Chi Group|Tai Chi: The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).
347180|NCT01126723|O2|Outcome|Educational Control Group|Education-Control: The Education-Control intervention consists of a 12 week, instructor-led attention control program consisting of health education and mind-body breathing exercises (two, one-hour sessions per week)
347181|NCT01126723|O1|Outcome|Tai Chi Group|Tai Chi: The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).
347182|NCT01126723|E2|Reported Event|Educational Control Group|Education-Control: The Education-Control intervention consists of a 12 week, instructor-led attention control program consisting of health education and mind-body breathing exercises (two, one-hour sessions per week)
347183|NCT01126723|E1|Reported Event|Tai Chi Group|Tai Chi: The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).
347184|NCT01126671|B3|Baseline|Total|Total of all reporting groups
347185|NCT01126671|B2|Baseline|High Dose Vitamin D|Subjects in this arm of the study took 1000 IU vit D3 daily.
347186|NCT01126671|B1|Baseline|Low Dose Vitamin D|Subjects in this arm of the study took 200 IU vit D3 daily.
347187|NCT01126671|P2|Participant Flow|High Dose Vitamin D|Subjects in this arm of the study took 1000 IU vit D3 daily.
347188|NCT01126671|P1|Participant Flow|Low Dose Vitamin D|Subjects in this arm of the study took 200 IU vit D3 daily.
347189|NCT01126671|O2|Outcome|High Dose Vitamin D|Subjects in this arm of the study took 1000 IU vit D3 daily.
347190|NCT01126671|O1|Outcome|Low Dose Vitamin D|Subjects in this arm of the study took 200 IU vit D3 daily.
347191|NCT01126671|O2|Outcome|High Dose Vitamin D|Subjects in this arm of the study took 1000 IU vit D3 daily.
347192|NCT01126671|O1|Outcome|Low Dose Vitamin D|Subjects in this arm of the study took 200 IU vit D3 daily.
347193|NCT01126671|E2|Reported Event|High Dose Vitamin D|Subjects in this arm of the study took 1000 IU vit D3 daily.
347194|NCT01126671|E1|Reported Event|Low Dose Vitamin D|Subjects in this arm of the study took 200 IU vit D3 daily.
347195|NCT01126619|B1|Baseline|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
347196|NCT01126619|P1|Participant Flow|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
347197|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
347198|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
347199|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
347200|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
347201|NCT01126619|O2|Outcome|Week 24|Week 24 Static Physician Global Assessment of Psoriasis, after 24 weeks of anti-TNF therapy.
347202|NCT01126619|O1|Outcome|Baseline|Baseline Static Physician Global Assessment of Psoriasis, prior to initiation of anti-TNF therapy.
347203|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
347204|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
347205|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
347206|NCT01126619|E1|Reported Event|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
347207|NCT01126593|B4|Baseline|Total|Total of all reporting groups
347208|NCT01126593|B3|Baseline|Study Group|Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
347209|NCT01126593|B2|Baseline|Control Group|The control group patients will receive no continuous infusion catheter.
347210|NCT01126593|B1|Baseline|Placebo Group|The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.
347211|NCT01126593|P3|Participant Flow|Study Group|Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
347212|NCT01126593|P2|Participant Flow|Control Group|The control group patients will receive no continuous infusion catheter.
347419|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
347213|NCT01126593|P1|Participant Flow|Placebo Group|The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.
347214|NCT01126593|O3|Outcome|Study Group|Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
347215|NCT01126593|O2|Outcome|Control Group|The control group patients will receive no continuous infusion catheter.
347216|NCT01126593|O1|Outcome|Placebo Group|The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.
347217|NCT01126593|E3|Reported Event|Study Group|Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
347218|NCT01126593|E2|Reported Event|Control Group|The control group patients will receive no continuous infusion catheter.
347219|NCT01126593|E1|Reported Event|Placebo Group|The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.
347220|NCT01126580|B4|Baseline|Total|Total of all reporting groups
347221|NCT01126580|B3|Baseline|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347222|NCT01126580|B2|Baseline|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347223|NCT01126580|B1|Baseline|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347224|NCT01126580|P3|Participant Flow|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347225|NCT01126580|P2|Participant Flow|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347226|NCT01126580|P1|Participant Flow|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347227|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347228|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347229|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347230|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347231|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347232|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347233|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347234|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347235|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347236|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347237|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347238|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347239|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347240|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347241|NCT01126580|O1|Outcome|1.5 mg or 0.75 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg) or 0.75 mg, subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347242|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347243|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347244|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347245|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347246|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347247|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347248|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347249|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
350628|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
347251|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347252|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347253|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347254|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347255|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347256|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347257|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347258|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347259|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347260|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347261|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347262|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347263|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347264|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347265|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347266|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347267|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347268|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347269|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347270|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347271|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347272|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347273|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347274|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347275|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347276|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347277|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347278|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347279|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347280|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347281|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347282|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347283|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347284|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347285|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347286|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347287|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
352908|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
347288|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347289|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347290|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347291|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347292|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347293|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347294|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347295|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347296|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347297|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347298|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347299|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347300|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347301|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347302|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347303|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347304|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347305|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347306|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347307|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347308|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347309|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347310|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347311|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347312|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347313|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347314|NCT01126580|E3|Reported Event|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
347315|NCT01126580|E2|Reported Event|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347316|NCT01126580|E1|Reported Event|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
347317|NCT01126541|B4|Baseline|Total|Total of all reporting groups
347318|NCT01126541|B3|Baseline|Nonrandomized: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.
347319|NCT01126541|B2|Baseline|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347320|NCT01126541|B1|Baseline|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347321|NCT01126541|P3|Participant Flow|Nonrandomized: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.
347420|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
347322|NCT01126541|P2|Participant Flow|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347323|NCT01126541|P1|Participant Flow|Randomized Retreatment Arm A: Rituximab 1000 Milligrams (mg)|Participants received rituximab 1000 mg intravenously (IV) on Days 1 and 15. After Week 24, if Disease Activity Score based on 28-Joint Count (DAS28) was greater than (>)3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and methotrexate (MTX) ≥10 milligrams per week (mg/week) by mouth or parenteral throughout course of treatment.
347324|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347325|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347326|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347327|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347328|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347329|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347330|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347331|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347332|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347333|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347334|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347335|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347336|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347337|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347338|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347456|NCT01126424|O3|Outcome|Placebo|Participants received 21 days of treatment with placebo.
352909|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
347339|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347340|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347341|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347342|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347343|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347344|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347345|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347346|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347347|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347348|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347349|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347350|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347351|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347352|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347353|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347354|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347355|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347415|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
347416|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
347356|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347357|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347358|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347359|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347360|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347361|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347362|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347363|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347364|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347365|NCT01126541|O1|Outcome|Randomized Re-treatment Arm A: Single 1000 mg IV Rituximab|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347366|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347367|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347368|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347369|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347370|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347371|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347372|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347417|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
350629|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
347373|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347374|NCT01126541|O2|Outcome|Nonrandomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.
347375|NCT01126541|O1|Outcome|Randomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347376|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347377|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347378|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347379|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347380|NCT01126541|O1|Outcome|Randomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347381|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347382|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347383|NCT01126541|O1|Outcome|Randomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347384|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347385|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347386|NCT01126541|O1|Outcome|Randomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347387|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347388|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347389|NCT01126541|O1|Outcome|Randomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347418|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
347390|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347391|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347392|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347393|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347394|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347395|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347396|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347397|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347398|NCT01126541|O2|Outcome|Nonrandomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.
347399|NCT01126541|O1|Outcome|Randomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347400|NCT01126541|E3|Reported Event|Nonrandomized: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.
347401|NCT01126541|E2|Reported Event|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
347402|NCT01126541|E1|Reported Event|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
347403|NCT01126437|B4|Baseline|Total|Total of all reporting groups
347404|NCT01126437|B3|Baseline|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
347405|NCT01126437|B2|Baseline|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
347406|NCT01126437|B1|Baseline|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
347407|NCT01126437|P3|Participant Flow|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
347408|NCT01126437|P2|Participant Flow|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
347409|NCT01126437|P1|Participant Flow|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
347410|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
347411|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
347412|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
347413|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
347414|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
347421|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
347422|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
347423|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
347424|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
347425|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
347426|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
347427|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
347428|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
347429|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
347430|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
347431|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
347432|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
347433|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
347434|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
347435|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
347436|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
347437|NCT01126437|E3|Reported Event|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~Tiotropium 18 mcg: HandiHaler"
347438|NCT01126437|E2|Reported Event|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
347439|NCT01126437|E1|Reported Event|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
347440|NCT01126424|B7|Baseline|Total|Total of all reporting groups
347441|NCT01126424|B6|Baseline|Placebo / Oxybutynin / Solifenacin|Participants received 21 days of each treatment in the following order: placebo, 10 mg oxybutynin, 5 mg solifenacin. There was a 21-day washout period between each treatment period.
347442|NCT01126424|B5|Baseline|Placebo / Solifenacin / Oxybutynin|Participants received 21 days of each treatment in the following order: placebo, 5 mg solifenacin, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.
347443|NCT01126424|B4|Baseline|Oxybutynin / Solifenacin / Placebo|Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, 5 mg solifenacin, placebo. There was a 21-day washout period between each treatment period.
347444|NCT01126424|B3|Baseline|Oxybutynin / Placebo / Solifenacin|Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, placebo, 5 mg solifenacin. There was a 21-day washout period between each treatment period.
347445|NCT01126424|B2|Baseline|Solifenacin / Placebo / Oxybutynin|Participants received 21 days of each treatment in the following order: 5 mg solifenacin, placebo, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.
347446|NCT01126424|B1|Baseline|Solifenacin / Oxybutynin / Placebo|Participants received 21 days of each treatment in the following order: 5 mg solifenacin, 10 mg oxybutynin, placebo. There was a 21-day washout period between each treatment period.
347447|NCT01126424|P6|Participant Flow|Placebo / Oxybutynin / Solifenacin|Participants received 21 days of each treatment in the following order: placebo, 10 mg oxybutynin, 5 mg solifenacin. There was a 21-day washout period between each treatment period.
347448|NCT01126424|P5|Participant Flow|Placebo / Solifenacin / Oxybutynin|Participants received 21 days of each treatment in the following order: placebo, 5 mg solifenacin, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.
347449|NCT01126424|P4|Participant Flow|Oxybutynin / Solifenacin / Placebo|Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, 5 mg solifenacin, placebo. There was a 21-day washout period between each treatment period.
347450|NCT01126424|P3|Participant Flow|Oxybutynin / Placebo / Solifenacin|Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, placebo, 5 mg solifenacin. There was a 21-day washout period between each treatment period.
347451|NCT01126424|P2|Participant Flow|Solifenacin / Placebo / Oxybutynin|Participants received 21 days of each treatment in the following order: 5 mg solifenacin, placebo, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.
347452|NCT01126424|P1|Participant Flow|Solifenacin / Oxybutynin / Placebo|Participants received 21 days of each treatment in the following order: 5 mg solifenacin, 10 mg oxybutynin, placebo. There was a 21-day washout period between each treatment period.
347453|NCT01126424|O3|Outcome|Placebo|Participants received 21 days of treatment with placebo.
347454|NCT01126424|O2|Outcome|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
347455|NCT01126424|O1|Outcome|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
347457|NCT01126424|O2|Outcome|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
347458|NCT01126424|O1|Outcome|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
347459|NCT01126424|O3|Outcome|Placebo|Participants received 21 days of treatment with placebo.
347460|NCT01126424|O2|Outcome|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
347461|NCT01126424|O1|Outcome|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
347462|NCT01126424|O3|Outcome|Placebo|Participants received 21 days of treatment with placebo.
347463|NCT01126424|O2|Outcome|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
347464|NCT01126424|O1|Outcome|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
347465|NCT01126424|O3|Outcome|Placebo|Participants received 21 days of treatment with placebo.
347466|NCT01126424|O2|Outcome|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
347467|NCT01126424|O1|Outcome|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
347468|NCT01126424|O3|Outcome|Placebo|Participants received 21 days of treatment with placebo.
347469|NCT01126424|O2|Outcome|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
347470|NCT01126424|O1|Outcome|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
347471|NCT01126424|E3|Reported Event|Placebo|Participants received 21 days of treatment with placebo.
347472|NCT01126424|E2|Reported Event|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
347473|NCT01126424|E1|Reported Event|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
347474|NCT01126359|B1|Baseline|All Study Participants|Includes participants randomized to receive Lidocaine first, then Placebo-Saline; and vice versa.
347475|NCT01126359|P2|Participant Flow|Placebo-Saline Then Lidocaine|Control dressing change: iv or po pain medication and injection of 1% saline retrograde up the suction tube. Then, interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge.
347476|NCT01126359|P1|Participant Flow|Lidocaine Then Placebo-Saline|Interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge. Then, control dressing change: iv or po pain medication and injection of 1% saline retrograde up the suction tube.
347477|NCT01126359|O3|Outcome|Lidocaine Minus Placebo-Saline Difference|Includes participants randomized to receive Lidocaine first, then Placebo-Saline; and vice versa. Each patient narcotic requirements are determined at each measured time point (during/after VAC dressing removal) as the Lidocaine minus Placebo-Saline difference (mg). A negative narcotic requirement difference indicates a reduction in medication dosed (mg) used during and after VAC dressing change in a crossover intervention technique.
347478|NCT01126359|O2|Outcome|Placebo-Saline|All patients who received placebo-saline prior to VAC dressing change.
347479|NCT01126359|O1|Outcome|Lidocaine|All patients who received lidocaine prior to VAC dressing change.
347480|NCT01126359|O3|Outcome|Lidocaine Minus Placebo-Saline Difference|Includes participants randomized to receive Lidocaine first, then Placebo-Saline; and vice versa. Visial Analog Pain Scores are determined at each pain measurement time point (during/after VAC dressing removal) as the Lidocaine minus Placebo-Saline VAS difference for each participant. A negative VAS difference indicates a reduction in the level of pain with Lidocaine compared to Placebo-Saline utilizing crossover intervention.
347481|NCT01126359|O2|Outcome|Placebo-Saline|All patients who received placebo-saline prior to VAC dressing change.
347482|NCT01126359|O1|Outcome|Lidocaine|All patients who received lidocaine prior to VAC dressing change.
347483|NCT01126359|E4|Reported Event|Second Intervention (Lidocaine)|
347484|NCT01126359|E3|Reported Event|Second Intervention (Placebo)|
347485|NCT01126359|E2|Reported Event|First Intervention (Placebo)|
347486|NCT01126359|E1|Reported Event|First Intervention (Lidocaine)|
347487|NCT01126268|B1|Baseline|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
347488|NCT01126268|P1|Participant Flow|Retapamulin Ointment 1% Group|Subjects with clinically diagnosed with impetigo, folliculitis, or minor soft tissue infection suitable for treatment with a topical antibiotic were screened, and if qualified, they received topical retapamulin ointment 1% twice daily for 5 days.
347489|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
347490|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
347491|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
347492|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
347493|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
347494|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
347495|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
347496|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
347497|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
347498|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
347499|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
347791|NCT01125722|O1|Outcome|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
347500|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
347501|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
347502|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
347503|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
347504|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
347505|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
347506|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
347507|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
347508|NCT01126268|E1|Reported Event|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
347509|NCT01126099|B3|Baseline|Total|Total of all reporting groups
347510|NCT01126099|B2|Baseline|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Placebo: Placebo capsules twice daily for 12 weeks"
347511|NCT01126099|B1|Baseline|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Prazosin: 4 mg capsules twice daily for 12 weeks"
347512|NCT01126099|P2|Participant Flow|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Placebo: Placebo capsules twice daily for 12 weeks"
347513|NCT01126099|P1|Participant Flow|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Prazosin: 4 mg capsules twice daily for 12 weeks"
347514|NCT01126099|O2|Outcome|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Placebo: Placebo capsules twice daily for 12 weeks"
347515|NCT01126099|O1|Outcome|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Prazosin: 4 mg capsules twice daily for 12 weeks"
347516|NCT01126099|O2|Outcome|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Placebo: Placebo capsules twice daily for 12 weeks"
347517|NCT01126099|O1|Outcome|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Prazosin: 4 mg capsules twice daily for 12 weeks"
347518|NCT01126099|O2|Outcome|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Placebo: Placebo capsules twice daily for 12 weeks"
347519|NCT01126099|O1|Outcome|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Prazosin: 4 mg capsules twice daily for 12 weeks"
347520|NCT01126099|O2|Outcome|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Placebo: Placebo capsules twice daily for 12 weeks"
347521|NCT01126099|O1|Outcome|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Prazosin: 4 mg capsules twice daily for 12 weeks"
347522|NCT01126099|E2|Reported Event|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Placebo: Placebo capsules twice daily for 12 weeks"
347523|NCT01126099|E1|Reported Event|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Prazosin: 4 mg capsules twice daily for 12 weeks"
347524|NCT01126060|B3|Baseline|Total|Total of all reporting groups
347525|NCT01126060|B2|Baseline|No Fibrin Sealant|No usage of fibrin sealant No usage of alternative drugs
347526|NCT01126060|B1|Baseline|Fibrin Sealant|drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage)
347527|NCT01126060|P2|Participant Flow|No Fibrin Sealant|No usage of fibrin sealant No usage of alternative drugs
347528|NCT01126060|P1|Participant Flow|Fibrin Sealant|drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage)
347529|NCT01126060|O2|Outcome|No Fibrin Sealant|No usage of fibrin sealant No usage of alternative drugs
347530|NCT01126060|O1|Outcome|Fibrin Sealant|drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage)
347531|NCT01126060|E2|Reported Event|No Fibrin Sealant|No usage of fibrin sealant No usage of alternative drugs
347532|NCT01126060|E1|Reported Event|Fibrin Sealant|drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage)
347533|NCT01125930|B3|Baseline|Total|Total of all reporting groups
347534|NCT01125930|B2|Baseline|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347728|NCT01125800|O2|Outcome|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
352910|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
347535|NCT01125930|B1|Baseline|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347536|NCT01125930|P2|Participant Flow|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347537|NCT01125930|P1|Participant Flow|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347538|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347539|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347540|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347541|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347542|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347543|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347544|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347545|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347546|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347547|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347548|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347549|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347550|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347551|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
348327|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
347552|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347553|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347554|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347555|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347556|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347557|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347558|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347559|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347560|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347561|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347562|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347563|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347564|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347565|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347566|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347567|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347568|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
350630|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
347569|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347570|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347571|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347572|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347573|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347574|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347575|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347576|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347577|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347578|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347579|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347580|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347581|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347582|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347583|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347584|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347585|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
350631|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
347586|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347587|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347588|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347589|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347590|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347591|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347592|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347593|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347594|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347595|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347596|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347597|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347598|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347599|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347600|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347601|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347602|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
350632|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
347603|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347604|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347605|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347606|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347607|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347608|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347609|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347610|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347611|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347612|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347613|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347614|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347615|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347616|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347617|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347618|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347619|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
348401|NCT01124162|E2|Reported Event|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
347620|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347621|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347622|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347623|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347624|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347625|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347626|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347627|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347628|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347629|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347630|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347631|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347632|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347633|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347634|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347635|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347636|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347729|NCT01125800|O1|Outcome|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
347637|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347638|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347639|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347640|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347641|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347642|NCT01125930|O10|Outcome|Atralin Gel at Week 24|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347643|NCT01125930|O9|Outcome|Vehicle Gel at Week 24|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347644|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347645|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347646|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347647|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347648|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347649|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347650|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347651|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347652|NCT01125930|O10|Outcome|Atralin Gel at Week 24|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347653|NCT01125930|O9|Outcome|Vehicle Gel at Week 24|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347730|NCT01125800|O5|Outcome|Adult Participants, LDE225 800 mg|Adult Participants were treated with LDE225 800 mg capsule once daily.
347654|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347655|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347656|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347657|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347658|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347659|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347660|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347661|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347662|NCT01125930|O10|Outcome|Atralin Gel at Week 24|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347663|NCT01125930|O9|Outcome|Vehicle Gel at Week 24|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347664|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347665|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347666|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347667|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347668|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347669|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347670|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
348402|NCT01124162|E1|Reported Event|Losartan|100 mg Losartan Tablets test product dosed in either period.
347671|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347672|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347673|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347674|NCT01125930|O10|Outcome|Atralin Gel at Week 24|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347675|NCT01125930|O9|Outcome|Vehicle Gel at Week 24|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347676|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347677|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347678|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347679|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347680|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347681|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347682|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347683|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347684|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347685|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347686|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347687|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347731|NCT01125800|O4|Outcome|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
347688|NCT01125930|E2|Reported Event|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
347689|NCT01125930|E1|Reported Event|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
347690|NCT01125917|B1|Baseline|Total BTDS 5, 10, 20|Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear
347691|NCT01125917|P1|Participant Flow|Total BTDS 5, 10, 20|Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear
347692|NCT01125917|O1|Outcome|Total BTDS 5, 10, 20|Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear
347693|NCT01125917|E1|Reported Event|Total BTDS 5, 10, 20|Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear
347694|NCT01125813|B1|Baseline|Human Cl-rhFVIII|recombinant Factor VIII : intravenous infusion of factor FVIII every other day.
347695|NCT01125813|P1|Participant Flow|Human Cl-rhFVIII|recombinant Factor VIII : intravenous infusion of factor FVIII every other day.
347696|NCT01125813|O1|Outcome|Human Cl-rhFVIII|recombinant Factor VIII : intravenous infusion of factor FVIII every other day.
347697|NCT01125813|O1|Outcome|Human Cl-rhFVIII|recombinant Factor VIII : intravenous infusion of factor FVIII every other day.
347698|NCT01125813|E1|Reported Event|Human Cl-rhFVIII|recombinant Factor VIII : intravenous infusion of factor FVIII every other day.
347699|NCT01125800|B6|Baseline|Total|Total of all reporting groups
347700|NCT01125800|B5|Baseline|Adult Participants, LDE225 800 mg|Adult Participants were treated with LDE225 800 mg capsule once daily.
347701|NCT01125800|B4|Baseline|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
347702|NCT01125800|B3|Baseline|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
347703|NCT01125800|B2|Baseline|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
347704|NCT01125800|B1|Baseline|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
347705|NCT01125800|P5|Participant Flow|Adult Participants, LDE225 800 mg|Adult Participants were treated with LDE225 800 mg capsule once daily.
347706|NCT01125800|P4|Participant Flow|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route. The Phase I , Phase II patients are pooled and summarized by dose levels. One pediatric patient enrolled in the Phase II portion at the 680 mg/m2 dose was pooled with 21 pediatric patients enrolled in Phase I at the same dose
347707|NCT01125800|P3|Participant Flow|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
347708|NCT01125800|P2|Participant Flow|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
347709|NCT01125800|P1|Participant Flow|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
347710|NCT01125800|O2|Outcome|Adult Participants|All adult Participants were treated with sonidegib 800 mg once daily in phase II portion of the study. Pediatric patients were also enrolled in phase II portion of the study at the recommended phase II pediatric dose - 680 mg/m^2
347711|NCT01125800|O1|Outcome|Pediatric Participants|All the pediatric Participants were treated with LDE225 dose determined in the Phase I (233, 372, 425 and 680 mg/m^2).
347712|NCT01125800|O5|Outcome|Adult Participants, LDE225 800 mg|Adult Participants were treated with LDE225 800 mg capsule once daily.
347713|NCT01125800|O4|Outcome|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
347714|NCT01125800|O3|Outcome|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
347715|NCT01125800|O2|Outcome|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
347716|NCT01125800|O1|Outcome|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
347717|NCT01125800|O1|Outcome|Pediatric Participants|All the pediatric Participants were treated with LDE225 dose determined in the Phase I (233, 372, 425 and 680 mg/m^2).
347718|NCT01125800|O4|Outcome|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
347719|NCT01125800|O3|Outcome|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
347720|NCT01125800|O2|Outcome|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
347721|NCT01125800|O1|Outcome|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
347722|NCT01125800|O4|Outcome|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
347723|NCT01125800|O3|Outcome|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
347724|NCT01125800|O2|Outcome|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
347725|NCT01125800|O1|Outcome|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
347726|NCT01125800|O4|Outcome|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
347727|NCT01125800|O3|Outcome|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
350633|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
347732|NCT01125800|O3|Outcome|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
347733|NCT01125800|O2|Outcome|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
347734|NCT01125800|O1|Outcome|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
347735|NCT01125800|O1|Outcome|All Participants|All participants received LDE225 233, 372, 425, 680, 800 mg/m^2 once daily through oral route until disease progression, unacceptable toxicity, or consent withdrawal.
347736|NCT01125800|O4|Outcome|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
347737|NCT01125800|O3|Outcome|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
347738|NCT01125800|O2|Outcome|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
347739|NCT01125800|O1|Outcome|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
347740|NCT01125800|E5|Reported Event|Adult Participants, LDE225 800 mg|Adult participants were treated with LDE225 800 mg capsule once daily.
347741|NCT01125800|E4|Reported Event|Pediatric Participants, LDE225 680 mg/m^2|Pediatric participants received LDE225 680 mg/m^2 once daily through oral route.
347742|NCT01125800|E3|Reported Event|Pediatric Participants, LDE225 425 mg/m^2|Pediatric participants received LDE225 425 mg/m^2 once daily through oral route.
347743|NCT01125800|E2|Reported Event|Pediatric Participants, LDE225 372 mg/m^2|Pediatric participants received LDE225 372 mg/m^2 once daily through oral route.
347744|NCT01125800|E1|Reported Event|Pediatric Participants, LDE225 233 mg/m^2|Pediatric participants received LDE225 233 mg/m^2 once daily through oral route.
347745|NCT01125774|B3|Baseline|Total|Total of all reporting groups
347746|NCT01125774|B2|Baseline|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
347747|NCT01125774|B1|Baseline|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
347748|NCT01125774|P4|Participant Flow|Placebo - Duplicate Participants|Participants who were randomized at more than 1 study site and each time were randomized to placebo. Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
347749|NCT01125774|P3|Participant Flow|Telcagepant 140 mg - Duplicate Participants|Participants who were randomized at more than 1 study site and were randomized at least once to telcagepant and may also have been randomized to placebo. Study drug was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
347750|NCT01125774|P2|Participant Flow|Placebo - Excluding Duplicate Participants|Participants who were randomized at only 1 study site and were randomized to placebo. Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
347751|NCT01125774|P1|Participant Flow|Telcagepant 140 mg - Excluding Duplicate Participants|Participants who were randomized at only 1 study site and were randomized to telcagepant. Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
347752|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
347753|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
347754|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
347755|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
347756|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
347757|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
347758|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
347759|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
347760|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
350634|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
347761|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
347762|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
347763|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
347764|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
347765|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
347766|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
347767|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
347768|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
347769|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
347770|NCT01125774|E2|Reported Event|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
347771|NCT01125774|E1|Reported Event|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
347772|NCT01125748|B3|Baseline|Total|Total of all reporting groups
347773|NCT01125748|B2|Baseline|Placebo|Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
347774|NCT01125748|B1|Baseline|Omalizumab|Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
347775|NCT01125748|P2|Participant Flow|Placebo|Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
347776|NCT01125748|P1|Participant Flow|Omalizumab|Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
347777|NCT01125748|O2|Outcome|Placebo|Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
347778|NCT01125748|O1|Outcome|Omalizumab|Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
347779|NCT01125748|O2|Outcome|Placebo|Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
347780|NCT01125748|O1|Outcome|Omalizumab|Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
347781|NCT01125748|E2|Reported Event|Placebo|Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
347782|NCT01125748|E1|Reported Event|Omalizumab|Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
347783|NCT01125722|B3|Baseline|Total|Total of all reporting groups
347784|NCT01125722|B2|Baseline|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
347785|NCT01125722|B1|Baseline|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
347786|NCT01125722|P2|Participant Flow|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
347787|NCT01125722|P1|Participant Flow|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
347788|NCT01125722|O2|Outcome|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
347789|NCT01125722|O1|Outcome|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
347790|NCT01125722|O2|Outcome|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
350635|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
347792|NCT01125722|O2|Outcome|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
347793|NCT01125722|O1|Outcome|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
347794|NCT01125722|O2|Outcome|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
347795|NCT01125722|O1|Outcome|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
347796|NCT01125722|O2|Outcome|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
347797|NCT01125722|O1|Outcome|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
347798|NCT01125722|E2|Reported Event|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
347799|NCT01125722|E1|Reported Event|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
347800|NCT01125605|B1|Baseline|Observational Group|Pasconal Nerventropfen
347801|NCT01125605|P1|Participant Flow|Observational Group|Pasconal Nerventropfen PASCONAL® NERVENTROPFEN is a homoeopathic combination product (oral drops) consisting out of 4 ingredients: Avena sativa, Valeriana, Ignatia and Tarantula.
347802|NCT01125605|O2|Outcome|Visit 3|Observational group (Pasconal Nerventropfen) at visit 3
347803|NCT01125605|O1|Outcome|Visit 2|Observational group (Pasconal Nerventropfen) at visit 2
347804|NCT01125605|O4|Outcome|Last Observation|Observational group (Pasconal Nerventropfen) at last observation
347805|NCT01125605|O3|Outcome|Visit 3|Observational group (Pasconal Nerventropfen) at visit 1
347806|NCT01125605|O2|Outcome|Visit 2|Observational group (Pasconal Nerventropfen) at visit 2
347807|NCT01125605|O1|Outcome|Visit 1|Observational group (Pasconal Nerventropfen) at visit 1
347808|NCT01125605|O2|Outcome|>= 4 Weeks|Observational group (Pasconal Nerventropfen) without concomitant medication
347809|NCT01125605|O1|Outcome|< 4 Weeks|Observational group (Pasconal Nerventropfen) with concomitant medication
347810|NCT01125605|O4|Outcome|Last Observation|Observational group (Pasconal Nerventropfen) at last observation
347811|NCT01125605|O3|Outcome|Visit 3|Observational group (Pasconal Nerventropfen) at visit 1
347812|NCT01125605|O2|Outcome|Visit 2|Observational group (Pasconal Nerventropfen) at visit 2
347813|NCT01125605|O1|Outcome|Visit 1|Observational group (Pasconal Nerventropfen) at visit 1
347814|NCT01125605|O2|Outcome|Without Concomitant Medication|Observational group (Pasconal Nerventropfen) without concomitant medication
347815|NCT01125605|O1|Outcome|With Concomitant Medication|Observational group (Pasconal Nerventropfen) with concomitant medication
347816|NCT01125605|O2|Outcome|> = 4 Weeks|Observational group (Pasconal Nerventropfen) with a treatment duration >= 4 weeks
347817|NCT01125605|O1|Outcome|< 4 Weeks|Observational group (Pasconal Nerventropfen) with a treatment duration < 4 weeks
347818|NCT01125605|O2|Outcome|Without Concomitant Medication|Observational group (Pasconal Nerventropfen) without concomitant medication
347819|NCT01125605|O1|Outcome|With Concomitant Medication|Observational group (Pasconal Nerventropfen) with concomitant medication
347820|NCT01125605|O2|Outcome|> = 4 Weeks|Observational group (Pasconal Nerventropfen) with a treatment duration >= 4 weeks
347821|NCT01125605|O1|Outcome|< 4 Weeks|Observational group (Pasconal Nerventropfen) with a treatment duration < 4 weeks
347822|NCT01125605|O2|Outcome|Without Concomitant Medication|Observational group (Pasconal Nerventropfen) without concomitant medication
347823|NCT01125605|O1|Outcome|With Concomitant Medication|Observational group (Pasconal Nerventropfen) with concomitant medication
347824|NCT01125605|O2|Outcome|Last Observation|Observational group (Pasconal Nerventropfen) at last observation
347825|NCT01125605|O1|Outcome|Visit 1|Observational group (Pasconal Nerventropfen) at visit 1
347826|NCT01125605|O4|Outcome|Last Observation|Observational group (Pasconal Nerventropfen) at last observation
347827|NCT01125605|O3|Outcome|Visit 3|Observational group (Pasconal Nerventropfen) at visit 3
347828|NCT01125605|O2|Outcome|Visit 2|Observational group (Pasconal Nerventropfen) at visit 2
347829|NCT01125605|O1|Outcome|Visit 1|Observational group (Pasconal Nerventropfen) at visit 1
347830|NCT01125605|E1|Reported Event|Observational Group|Pasconal Nerventropfen
347831|NCT01125566|B3|Baseline|Total|Total of all reporting groups
347832|NCT01125566|B2|Baseline|Trastuzumab + Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
347833|NCT01125566|B1|Baseline|Afatinib + Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
347834|NCT01125566|P3|Participant Flow|AV Switched to TV|This group describes patients who crossed over from AV to TV following DMC recommendation to terminate recruitment on 26Apr2013. Patients discontinued AV and switched to TV if they were without disease progression on Afatinib+ Vinorelbine treatment on 26Apr2013.
347835|NCT01125566|P2|Participant Flow|Trastuzumab+ Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
347854|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
347855|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
352911|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
347836|NCT01125566|P1|Participant Flow|Afatinib+ Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
347837|NCT01125566|O2|Outcome|Trastuzumab+ Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
347838|NCT01125566|O1|Outcome|Afatinib+ Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
347839|NCT01125566|O2|Outcome|Trastuzumab+ Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
347840|NCT01125566|O1|Outcome|Afatinib+ Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
347841|NCT01125566|O2|Outcome|Trastuzumab+ Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
347842|NCT01125566|O1|Outcome|Afatinib+ Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
347843|NCT01125566|O2|Outcome|Trastuzumab+ Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
347844|NCT01125566|O1|Outcome|Afatinib+ Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
347845|NCT01125566|E3|Reported Event|AV Switched to TV|This group describes patients who crossed over from AV to TV following DMC recommendation to terminate recruitment on 26Apr2013. Patients discontinued AV and switched to TV if they were without disease progression on Afatinib+ Vinorelbine treatment on 26Apr2013.
347846|NCT01125566|E2|Reported Event|Trastuzumab+ Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
347847|NCT01125566|E1|Reported Event|Afatinib+ Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
347848|NCT01125514|B1|Baseline|Furosemide (Fu) /Fu+Aliskiren(Alis)150mg/fu+Alis 300mg|"Treatment period 1 (Day 1 to Day 7): All eligible patients received 60 mg furosemide, 150 mg placebo of aliskiren, and 300 mg placebo aliskiren once daily.~Treatment Period 2 (Day 8 to day 17): Patients received 60 mg furosemide, 150 mg aliskiren and 300 mg placebo once daily.~Treatment Period 3 (Day 18 to day 27): Patients received 60 mg furosemide, 300 mg aliskiren and 150 mg placebo of aliskiren once daily.~Day 28, no study treatment."
347849|NCT01125514|P1|Participant Flow|Furosemide (Fu) /Fu+Aliskiren(Alis)150mg/fu+Alis 300mg|"Treatment period 1 (Day 1 to Day 7): All eligible patients received 60 mg furosemide, 150 mg placebo of aliskiren, and 300 mg placebo aliskiren once daily.~Treatment Period 2 (Day 8 to day 17): Patients received 60 mg furosemide, 150 mg aliskiren and 300 mg placebo once daily.~Treatment Period 3 (Day 18 to day 27): Patients received 60 mg furosemide, 300 mg aliskiren and 150 mg placebo of aliskiren once daily.~Day 28, no study treatment."
347850|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
347851|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
347852|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
347853|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
347856|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
347857|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
347858|NCT01125514|O3|Outcome|Furosemide go mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
347859|NCT01125514|O2|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
347860|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
347861|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
347862|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
347863|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
347864|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
347865|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
347866|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
347867|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
347868|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
347869|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
347870|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
347871|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
347872|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
347873|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
347874|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
347875|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
347876|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
347877|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
347878|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
347879|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
347880|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
347881|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
347882|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
347883|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
347884|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
347885|NCT01125514|O4|Outcome|Furosemide 60 mg+ Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
347886|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
347887|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
347888|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
347889|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
347890|NCT01125514|O3|Outcome|Furosemide 60 mg+ Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
347891|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
347892|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
347893|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
347894|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
347895|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
347896|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
347897|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
347898|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
347899|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
347900|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
347901|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
347902|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
347903|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
347904|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
347905|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
347906|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
347907|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
347908|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
347909|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
347910|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
347911|NCT01125514|O2|Outcome|Furosemide 60 mg+ Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
347912|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
347913|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
347914|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
347915|NCT01125514|O2|Outcome|Furosemide 60 mg+ Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
347916|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
347917|NCT01125514|E3|Reported Event|60 mg Furosemide + 300 mg Aliskiren + 150 mg Placebo|60 mg furosemide + 300 mg aliskiren + 150 mg placebo
347918|NCT01125514|E2|Reported Event|60 mg Furosemide + 150 mg Aliskiren + 300 mg Placebo|60 mg furosemide + 150 mg aliskiren + 300 mg placebo
347919|NCT01125514|E1|Reported Event|60 mg Furosemide + 150 mg Placebo + 300 mg Placebo|60 mg furosemide + 150 mg placebo + 300 mg placebo
347920|NCT01125202|B3|Baseline|Total|Total of all reporting groups
347921|NCT01125202|B2|Baseline|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.~Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
347922|NCT01125202|B1|Baseline|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.~Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
347923|NCT01125202|P2|Participant Flow|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.~Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
347924|NCT01125202|P1|Participant Flow|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.~Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
347925|NCT01125202|O2|Outcome|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.~Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
348403|NCT01124149|B1|Baseline|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase and 2.4g/day given QD for 12 months in the Maintenance Phase
347926|NCT01125202|O1|Outcome|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.~Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
347927|NCT01125202|O2|Outcome|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.~Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
347928|NCT01125202|O1|Outcome|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.~Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
347929|NCT01125202|O2|Outcome|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.~Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
347930|NCT01125202|O1|Outcome|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.~Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
347931|NCT01125202|O2|Outcome|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.~Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
347932|NCT01125202|O1|Outcome|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.~Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
347933|NCT01125202|O2|Outcome|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.~Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
347934|NCT01125202|O1|Outcome|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.~Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
347935|NCT01125202|O2|Outcome|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.~Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
347936|NCT01125202|O1|Outcome|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.~Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
347964|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
352912|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
347937|NCT01125202|O2|Outcome|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.~Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
347938|NCT01125202|O1|Outcome|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.~Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
347939|NCT01125202|O2|Outcome|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.~Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
347940|NCT01125202|O1|Outcome|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.~Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
347941|NCT01125202|O2|Outcome|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.~Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
347942|NCT01125202|O1|Outcome|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.~Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
347943|NCT01125202|E2|Reported Event|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.~Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
347944|NCT01125202|E1|Reported Event|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.~Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
347945|NCT01125189|B4|Baseline|Total|Total of all reporting groups
347946|NCT01125189|B3|Baseline|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
347947|NCT01125189|B2|Baseline|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
347948|NCT01125189|B1|Baseline|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
347949|NCT01125189|P3|Participant Flow|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
348011|NCT01124916|E2|Reported Event|Robotic Assisted Laparoscopic (RASC)|Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
348012|NCT01124916|E1|Reported Event|Laparoscopic Abdominal Sacrocolpopexy (LASC)|Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
347950|NCT01125189|P2|Participant Flow|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
347951|NCT01125189|P1|Participant Flow|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
347952|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
347953|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
347954|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
347955|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
347956|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-­interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
347957|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-­interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
347958|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylate-­interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
347959|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
347960|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
347961|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
347962|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
347963|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-­interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
348013|NCT01124864|B7|Baseline|Total|Total of all reporting groups
350636|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
347965|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
347966|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
347967|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
347968|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
347969|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
347970|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
347971|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
347972|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
347973|NCT01125189|E3|Reported Event|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
347974|NCT01125189|E2|Reported Event|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the patient achieved an on-treatment response as defined in protocol.
347975|NCT01125189|E1|Reported Event|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-­interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the patient achieved an on-treatment response as defined in protocol.
347976|NCT01125098|B3|Baseline|Total|Total of all reporting groups
347977|NCT01125098|B2|Baseline|Standard Group: No Intervention|COPD patients in the Standard group will continue antibiotic therapy for 10 days according to guidelines recommended treatment plan in case of COPD exacerbations.
347978|NCT01125098|B1|Baseline|PRO-CT Group: Experimental|"COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.~PRO-CT values: - continue antibiotics for 10 days if a single PRO-CT value is 0.25 mcg/L or greater, that will be judged suggestive of bacterial infection~continue antibiotics from day 3 to day 10 if one or more PRO-CT values are 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, PLUS acute respiratory failure or clinical instability~stop antibiotics on day 3, if one or more PRO-CT values are between 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, BUT the patient has not acute respiratory failure or clinical instability~stop antibiotics if all the PRO-CT values are < 0.1 mcg/L or if there is a consistent trend to normalization of PRO-CT with the last value < 0.1 mcg/L, that will be judged suggestive of absence of bacterial infection."
347979|NCT01125098|P2|Participant Flow|Standard Group: No Intervention|COPD patients in the Standard group will continue antibiotic therapy for 10 days according to guidelines recommended treatment plan in case of COPD exacerbations.
348014|NCT01124864|B6|Baseline|Unknown|For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
347980|NCT01125098|P1|Participant Flow|PRO-CT Group: Experimental|"COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.~PRO-CT values: - continue antibiotics for 10 days if a single PRO-CT value is 0.25 mcg/L or greater, that will be judged suggestive of bacterial infection~continue antibiotics from day 3 to day 10 if one or more PRO-CT values are 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, PLUS acute respiratory failure or clinical instability~stop antibiotics on day 3, if one or more PRO-CT values are between 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, BUT the patient has not acute respiratory failure or clinical instability~stop antibiotics if all the PRO-CT values are < 0.1 mcg/L or if there is a consistent trend to normalization of PRO-CT with the last value < 0.1 mcg/L, that will be judged suggestive of absence of bacterial infection."
347981|NCT01125098|O2|Outcome|Standard Group: No Intervention|COPD patients in the Standard group will continue antibiotic therapy for 10 days according to guidelines recommended treatment plan in case of COPD exacerbations.
347982|NCT01125098|O1|Outcome|PRO-CT Group: Experimental|"COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.~PRO-CT values: - continue antibiotics for 10 days if a single PRO-CT value is 0.25 mcg/L or greater, that will be judged suggestive of bacterial infection~continue antibiotics from day 3 to day 10 if one or more PRO-CT values are 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, PLUS acute respiratory failure or clinical instability~stop antibiotics on day 3, if one or more PRO-CT values are between 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, BUT the patient has not acute respiratory failure or clinical instability~stop antibiotics if all the PRO-CT values are < 0.1 mcg/L or if there is a consistent trend to normalization of PRO-CT with the last value < 0.1 mcg/L, that will be judged suggestive of absence of bacterial infection."
347983|NCT01125098|E2|Reported Event|Standard Group: No Intervention|COPD patients in the Standard group will continue antibiotic therapy for 10 days according to guidelines recommended treatment plan in case of COPD exacerbations.
347984|NCT01125098|E1|Reported Event|PRO-CT Group: Experimental|"COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.~PRO-CT values: - continue antibiotics for 10 days if a single PRO-CT value is 0.25 mcg/L or greater, that will be judged suggestive of bacterial infection~continue antibiotics from day 3 to day 10 if one or more PRO-CT values are 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, PLUS acute respiratory failure or clinical instability~stop antibiotics on day 3, if one or more PRO-CT values are between 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, BUT the patient has not acute respiratory failure or clinical instability~stop antibiotics if all the PRO-CT values are < 0.1 mcg/L or if there is a consistent trend to normalization of PRO-CT with the last value < 0.1 mcg/L, that will be judged suggestive of absence of bacterial infection."
347985|NCT01124955|B3|Baseline|Total|Total of all reporting groups
347986|NCT01124955|B2|Baseline|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
347987|NCT01124955|B1|Baseline|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
347988|NCT01124955|P2|Participant Flow|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
347989|NCT01124955|P1|Participant Flow|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
347990|NCT01124955|O2|Outcome|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
347991|NCT01124955|O1|Outcome|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
347992|NCT01124955|O2|Outcome|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
347993|NCT01124955|O1|Outcome|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
347994|NCT01124955|O2|Outcome|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
347995|NCT01124955|O1|Outcome|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
347996|NCT01124955|O2|Outcome|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
347997|NCT01124955|O1|Outcome|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
347998|NCT01124955|O2|Outcome|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
347999|NCT01124955|O1|Outcome|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
348000|NCT01124955|E2|Reported Event|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
348001|NCT01124955|E1|Reported Event|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
348002|NCT01124916|B3|Baseline|Total|Total of all reporting groups
348003|NCT01124916|B2|Baseline|Robotic Assisted Laparoscopic (RASC)|Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
348004|NCT01124916|B1|Baseline|Laparoscopic Abdominal Sacrocolpopexy (LASC)|Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
348005|NCT01124916|P2|Participant Flow|Robotic Assisted Laparoscopic (RASC)|Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
348006|NCT01124916|P1|Participant Flow|Laparoscopic Abdominal Sacrocolpopexy (LASC)|Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
348007|NCT01124916|O2|Outcome|Robotic Assisted Laparoscopic (RASC)|Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
348008|NCT01124916|O1|Outcome|Laparoscopic Abdominal Sacrocolpopexy (LASC)|Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
348009|NCT01124916|O2|Outcome|Robotic Assisted Laparoscopic (RASC)|Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
348010|NCT01124916|O1|Outcome|Laparoscopic Abdominal Sacrocolpopexy (LASC)|Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
348249|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
348015|NCT01124864|B5|Baseline|Modified EGFR Mutant Patients|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348016|NCT01124864|B4|Baseline|Patients With EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348017|NCT01124864|B3|Baseline|EGFR and Kras Wild Type Patients|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348018|NCT01124864|B2|Baseline|EGFR Mutant Patients|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
348019|NCT01124864|B1|Baseline|Kras Mutant Patients|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348020|NCT01124864|P6|Participant Flow||For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348021|NCT01124864|P5|Participant Flow|Modified EGFR Mutant Patients|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348022|NCT01124864|P4|Participant Flow|Patients With EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348023|NCT01124864|P3|Participant Flow|EGFR and Kras Wild Type Patients|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348024|NCT01124864|P2|Participant Flow|EGFR Mutant Patients|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
348025|NCT01124864|P1|Participant Flow|Kras Mutant Patients|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348026|NCT01124864|O2|Outcome|BJP762|AUY Metabolite
348027|NCT01124864|O1|Outcome|AUY922|AUY922 Plasma Concentration
348028|NCT01124864|O2|Outcome|BJP762|AUY Metabolite
348029|NCT01124864|O1|Outcome|AUY922|AUY922 Plasma Concentration
348030|NCT01124864|O2|Outcome|BJP762|AUY Metabolite
348031|NCT01124864|O1|Outcome|AUY922|AUY922 Plasma Concentration
348032|NCT01124864|O6|Outcome|Unknown|For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348033|NCT01124864|O5|Outcome|Modified EGFR Mutant Patients|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348034|NCT01124864|O4|Outcome|Patients With EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348035|NCT01124864|O3|Outcome|EGFR and Kras Wild Type Patients|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348036|NCT01124864|O2|Outcome|EGFR Mutant Patients|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
348037|NCT01124864|O1|Outcome|Kras Mutant Patients|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348038|NCT01124864|O6|Outcome|Unknown|For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348039|NCT01124864|O5|Outcome|Modified EGFR Mutant Patients|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348040|NCT01124864|O4|Outcome|Patients With EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
352913|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
348041|NCT01124864|O3|Outcome|EGFR and Kras Wild Type Patients|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348042|NCT01124864|O2|Outcome|EGFR Mutant Patients|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
348043|NCT01124864|O1|Outcome|Kras Mutant Patients|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348044|NCT01124864|O6|Outcome|Unknown|For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348045|NCT01124864|O5|Outcome|Modified EGFR Mutant Patients|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348046|NCT01124864|O4|Outcome|Patients With EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348047|NCT01124864|O3|Outcome|EGFR and Kras Wild Type Patients|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348048|NCT01124864|O2|Outcome|EGFR Mutant Patients|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
348049|NCT01124864|O1|Outcome|Kras Mutant Patients|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348050|NCT01124864|E6|Reported Event||For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348051|NCT01124864|E5|Reported Event|Modified EGFR Mutant|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI.Patients received AUY922 at 70 mg/m^2 weekly infusions.
348052|NCT01124864|E4|Reported Event|EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348053|NCT01124864|E3|Reported Event|KRAS and EGFR Wild Type|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348054|NCT01124864|E2|Reported Event|EGFR Mutant|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
348055|NCT01124864|E1|Reported Event|KRAS Mutant|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
348056|NCT01124838|B3|Baseline|Total|Total of all reporting groups
348057|NCT01124838|B2|Baseline|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348058|NCT01124838|B1|Baseline|Placebo|Participants received placebo subcutaneous injection at Baseline followed by every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 to 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348059|NCT01124838|P2|Participant Flow|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348060|NCT01124838|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection at Baseline followed by every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 to 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348061|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348062|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348063|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
352914|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
348064|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348065|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348066|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348067|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348068|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348069|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348070|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348071|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348072|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348073|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348074|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348075|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348076|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348077|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348078|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348079|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348080|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348326|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
348081|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348082|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348083|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348084|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348085|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348086|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348087|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348088|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348089|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348090|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348091|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348092|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348093|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348094|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348095|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348096|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348097|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
350637|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
348098|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348099|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348100|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348101|NCT01124838|E2|Reported Event|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348102|NCT01124838|E1|Reported Event|Placebo|Participants received placebo subcutaneous injection at Baseline followed by every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 to 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
348103|NCT01124786|B3|Baseline|Total|Total of all reporting groups
348104|NCT01124786|B2|Baseline|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
348105|NCT01124786|B1|Baseline|Gemcitabine Elaidate|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
348106|NCT01124786|P2|Participant Flow|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
348107|NCT01124786|P1|Participant Flow|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
348108|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
348109|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
348110|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
348111|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
348112|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
348113|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
348114|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
348115|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
348116|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
348117|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
348118|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
348119|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
348120|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
348121|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
348122|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
348123|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
348124|NCT01124786|E2|Reported Event|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
348125|NCT01124786|E1|Reported Event|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
348126|NCT01124643|B1|Baseline|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
348127|NCT01124643|P1|Participant Flow|Replagal® (0.2 mg/kg)|Replagal 0.2 milligram per kilogram (mg/kg) intravenously (IV), every other week (EOW).
348128|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
348129|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
348130|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
348131|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
348132|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
348133|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
348134|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
348135|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
348136|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
348137|NCT01124643|E1|Reported Event|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
348138|NCT01124617|B3|Baseline|Total|Total of all reporting groups
348139|NCT01124617|B2|Baseline|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
348140|NCT01124617|B1|Baseline|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
348141|NCT01124617|P2|Participant Flow|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
348142|NCT01124617|P1|Participant Flow|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
348143|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
348144|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
348145|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
348146|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
348147|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
348148|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
348149|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
348150|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
348151|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
348152|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
348153|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
348154|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
348155|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
348156|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
348157|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
348158|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
348159|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
348160|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
348161|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
348162|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
348163|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
348164|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
348165|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
348166|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
348167|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
348168|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
348169|NCT01124617|E2|Reported Event|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
348170|NCT01124617|E1|Reported Event|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
348171|NCT01124604|B3|Baseline|Total|Total of all reporting groups
348172|NCT01124604|B2|Baseline|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348173|NCT01124604|B1|Baseline|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348174|NCT01124604|P2|Participant Flow|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348175|NCT01124604|P1|Participant Flow|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348176|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348177|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348178|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348179|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348180|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348181|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348182|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348183|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348184|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348185|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348186|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348187|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348188|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348189|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348190|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348191|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348192|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348193|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348194|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348195|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348196|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348197|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348198|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348199|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348200|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348201|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348202|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348203|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348204|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348205|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348206|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348207|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348208|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348209|NCT01124604|E2|Reported Event|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348210|NCT01124604|E1|Reported Event|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
348211|NCT01124448|B3|Baseline|Total|Total of all reporting groups
352915|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
348212|NCT01124448|B2|Baseline|Lactobacillus Salivarius PS2B|"Lactating women without mastitis (n=15)~Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days"
348213|NCT01124448|B1|Baseline|Lactobacillus Salivarius PS2|"Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)~Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days"
348214|NCT01124448|P2|Participant Flow|Lactobacillus Salivarius PS2B|"Lactating women without mastitis (n=15)~Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days"
348215|NCT01124448|P1|Participant Flow|Lactobacillus Salivarius PS2|"Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)~Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days"
348216|NCT01124448|O2|Outcome|Lactobacillus Salivarius PS2B|"Lactating women without mastitis (n=15)~Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days"
348217|NCT01124448|O1|Outcome|Lactobacillus Salivarius PS2|"Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)~Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days"
348218|NCT01124448|E2|Reported Event|Lactobacillus Salivarius PS2B|"Lactating women without mastitis (n=15)~Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days"
348219|NCT01124448|E1|Reported Event|Lactobacillus Salivarius PS2|"Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)~Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days"
348220|NCT01124422|B3|Baseline|Total|Total of all reporting groups
348221|NCT01124422|B2|Baseline|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
348222|NCT01124422|B1|Baseline|TIO+Placebo|Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks
348223|NCT01124422|P3|Participant Flow|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
348224|NCT01124422|P2|Participant Flow|TIO+Placebo|Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks
348225|NCT01124422|P1|Participant Flow|Tiotropium (TIO)|Tiotropium (TIO) was administered in the dose of 18 micrograms (mcg) once daily for a duration of 4 weeks
348226|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
348227|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
348228|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
348229|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
348230|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
348231|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
348232|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
348233|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
348234|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
348235|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
348236|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
348237|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
348238|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
348239|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
348240|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
348241|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
348242|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
348243|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
348244|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
348245|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
348246|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
348247|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
348248|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
352916|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
348250|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
348251|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
348252|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
348253|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
348254|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
348255|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
348256|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
348257|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
348258|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
348259|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
348260|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
348261|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks
348262|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
348263|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks
348264|NCT01124422|E2|Reported Event|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
348265|NCT01124422|E1|Reported Event|TIO+Placebo|Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks
348266|NCT01124370|B1|Baseline|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
348267|NCT01124370|P1|Participant Flow|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
348268|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
348269|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
348270|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
348271|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
348272|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
348273|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
348274|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
348275|NCT01124370|E1|Reported Event|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
348276|NCT01124305|B3|Baseline|Total|Total of all reporting groups
348277|NCT01124305|B2|Baseline|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
348278|NCT01124305|B1|Baseline|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
348279|NCT01124305|P2|Participant Flow|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
348280|NCT01124305|P1|Participant Flow|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
348281|NCT01124305|O2|Outcome|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
348282|NCT01124305|O1|Outcome|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
348283|NCT01124305|O2|Outcome|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
348284|NCT01124305|O1|Outcome|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
348285|NCT01124305|O2|Outcome|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
348286|NCT01124305|O1|Outcome|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
348287|NCT01124305|O2|Outcome|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
348288|NCT01124305|O1|Outcome|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
348289|NCT01124305|E2|Reported Event|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
348290|NCT01124305|E1|Reported Event|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
348291|NCT01124292|B4|Baseline|Total|Total of all reporting groups
350638|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
348292|NCT01124292|B3|Baseline|Subjects With Spinal Cord Injury|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
348293|NCT01124292|B2|Baseline|Able-bodied Subject Without Tongue Piercing:|Able-bodied subjects who willing to receive a tongue piercing for this study.
348294|NCT01124292|B1|Baseline|Able-bodied Subject With Tongue Piercing|Able-bodied subjects who already have tongue piercing.
348295|NCT01124292|P3|Participant Flow|Subjects With Spinal Cord Injury|persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
348296|NCT01124292|P2|Participant Flow|Able-bodied Subject Without Tongue Piercing|Able-bodied subjects who willing to receive a tongue piercing for this study.
348297|NCT01124292|P1|Participant Flow|Able-bodied Subject With Tongue Piercing|Able-bodied subjects who already have tongue piercing.
348298|NCT01124292|O4|Outcome|Subjects With Spinal Cord Injury (Group-C): Wheelchair Session|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
348299|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C): Computer Session|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
348300|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
348301|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
348302|NCT01124292|O1|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
348303|NCT01124292|O1|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
348304|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
348305|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
348306|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
348307|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
348308|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
348309|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
348310|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
348311|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
348312|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
348313|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
348314|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
348315|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
348316|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
348317|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
348318|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
348319|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
348320|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
348321|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
348322|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
348323|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
348324|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
348325|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
348328|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
348329|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
348330|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
348331|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
348332|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
348333|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
348334|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
348335|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
348336|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
348337|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
348338|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
348339|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
348340|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
348341|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
348342|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
348343|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
348344|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
348345|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
348346|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
348347|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
348348|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
348349|NCT01124292|E3|Reported Event|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
348350|NCT01124292|E2|Reported Event|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
348351|NCT01124292|E1|Reported Event|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
348352|NCT01124188|B3|Baseline|Total|Total of all reporting groups
348353|NCT01124188|B2|Baseline|Active Control|"Higher-dose venlafaxine and supportive management (SM)~Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks."
348354|NCT01124188|B1|Baseline|Study Intervention Arm|"Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)~Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks."
348355|NCT01124188|P2|Participant Flow|Active Control|"Higher-dose venlafaxine and supportive management (SM)~Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks."
348356|NCT01124188|P1|Participant Flow|Study Intervention Arm|"Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)~Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks."
348357|NCT01124188|O2|Outcome|Active Control|"Higher-dose venlafaxine and supportive management (SM)~Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks."
348358|NCT01124188|O1|Outcome|Study Intervention Arm|"Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)~Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks."
352917|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
348359|NCT01124188|O2|Outcome|Active Control|"Higher-dose venlafaxine and supportive management (SM)~Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks."
348360|NCT01124188|O1|Outcome|Study Intervention Arm|"Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)~Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks."
348361|NCT01124188|O2|Outcome|Active Control|"Higher-dose venlafaxine and supportive management (SM)~Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks."
348362|NCT01124188|O1|Outcome|Study Intervention Arm|"Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)~Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks."
348363|NCT01124188|E2|Reported Event|Active Control|"Higher-dose venlafaxine and supportive management (SM)~Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks."
348364|NCT01124188|E1|Reported Event|Study Intervention Arm|"Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)~Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks."
348365|NCT01124175|B3|Baseline|Total|Total of all reporting groups
348366|NCT01124175|B2|Baseline|Cozaar® (Reference) First|100 mg Cozaar® Tablets reference product dosed in first period followed by 100 mg Losartan Tablets test product dosed in the second period.
348367|NCT01124175|B1|Baseline|Losartan (Test) First|100 mg Losartan tablets test product dosed in first period followed by 100 mg Cozaar® Tablets reference product dosed in the second period.
348368|NCT01124175|P2|Participant Flow|Cozaar® (Reference) First|100 mg Cozaar® Tablets reference product dosed in first period followed by 100 mg Losartan Tablets test product dosed in the second period.
348369|NCT01124175|P1|Participant Flow|Losartan (Test) First|100 mg Losartan tablets test product dosed in first period followed by 100 mg Cozaar® Tablets reference product dosed in the second period.
348370|NCT01124175|O2|Outcome|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
348371|NCT01124175|O1|Outcome|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
348372|NCT01124175|O2|Outcome|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
348373|NCT01124175|O1|Outcome|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
348374|NCT01124175|O2|Outcome|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
348375|NCT01124175|O1|Outcome|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
348376|NCT01124175|O2|Outcome|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
348377|NCT01124175|O1|Outcome|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
348378|NCT01124175|O2|Outcome|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
348379|NCT01124175|O1|Outcome|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
348380|NCT01124175|O2|Outcome|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
348381|NCT01124175|O1|Outcome|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
348382|NCT01124175|E2|Reported Event|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
348383|NCT01124175|E1|Reported Event|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
348384|NCT01124162|B3|Baseline|Total|Total of all reporting groups
348385|NCT01124162|B2|Baseline|Cozaar® (Reference) First|100 mg Cozaar® Tablets reference product dosed in first period followed by 100 mg Losartan Tablets test product dosed in the second period.
348386|NCT01124162|B1|Baseline|Losartan (Test) First|100 mg Losartan Tablets test product dosed in first period followed by 100 mg Cozaar® Tablets reference product dosed in the second period.
348387|NCT01124162|P2|Participant Flow|Cozaar® (Reference) First|100 mg Cozaar® Tablets reference product dosed in first period followed by 100 mg Losartan Tablets test product dosed in the second period.
348388|NCT01124162|P1|Participant Flow|Losartan (Test) First|100 mg Losartan Tablets test product dosed in first period followed by 100 mg Cozaar® Tablets reference product dosed in the second period.
348389|NCT01124162|O2|Outcome|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
348390|NCT01124162|O1|Outcome|Losartan|100 mg Losartan Tablets test product dosed in either period.
348391|NCT01124162|O2|Outcome|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
348392|NCT01124162|O1|Outcome|Losartan|100 mg Losartan Tablets test product dosed in either period.
348393|NCT01124162|O2|Outcome|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
348394|NCT01124162|O1|Outcome|Losartan|100 mg Losartan Tablets test product dosed in either period.
348395|NCT01124162|O2|Outcome|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
348396|NCT01124162|O1|Outcome|Losartan|100 mg Losartan Tablets test product dosed in either period.
348397|NCT01124162|O2|Outcome|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
348398|NCT01124162|O1|Outcome|Losartan|100 mg Losartan Tablets test product dosed in either period.
348399|NCT01124162|O2|Outcome|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
348400|NCT01124162|O1|Outcome|Losartan|100 mg Losartan Tablets test product dosed in either period.
348404|NCT01124149|P1|Participant Flow|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase and 2.4g/day given QD for 12 months in the Maintenance Phase
348405|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase
348406|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase
348407|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase
348408|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase
348409|NCT01124149|O2|Outcome|MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
348410|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
348411|NCT01124149|O2|Outcome|MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
348412|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
348413|NCT01124149|O2|Outcome|MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
348414|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
348415|NCT01124149|O2|Outcome|MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
348416|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
348417|NCT01124149|E2|Reported Event|MMX Mesalamine/ Mesalazine (Maintenance Phase)|2.4 g/day given QD for 12 months in the Maintenance Phase
348418|NCT01124149|E1|Reported Event|MMX Mesalamine/ Mesalazine (Acute Phase)|4.8g/day given QD for 8 weeks in the Acute Phase
348419|NCT01124097|B5|Baseline|Total|Total of all reporting groups
348420|NCT01124097|B4|Baseline|Placebo|Placebo: Tablets will be used.
348421|NCT01124097|B3|Baseline|Esl 800 mg Once Daily (QD)|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
348422|NCT01124097|B2|Baseline|Esl 1200 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
348423|NCT01124097|B1|Baseline|Esl 1600 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
348424|NCT01124097|P4|Participant Flow|Placebo|Placebo: Tablets will be used.
348425|NCT01124097|P3|Participant Flow|Esl 800 mg Once Daily (QD)|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
348426|NCT01124097|P2|Participant Flow|Esl 1200 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
348427|NCT01124097|P1|Participant Flow|Esl 1600 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
348428|NCT01124097|O4|Outcome|Placebo|Placebo: Tablets will be used.
348429|NCT01124097|O3|Outcome|Esl 800 mg Once Daily (QD)|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
348430|NCT01124097|O2|Outcome|Esl 1200 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
348431|NCT01124097|O1|Outcome|Esl 1600 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
348432|NCT01124097|E4|Reported Event|Placebo|Placebo: Tablets will be used.
348433|NCT01124097|E3|Reported Event|Esl 800 mg Once Daily (QD)|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
348434|NCT01124097|E2|Reported Event|Esl 1200 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
348435|NCT01124097|E1|Reported Event|Esl 1600 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
348436|NCT01124045|B3|Baseline|Total|Total of all reporting groups
348437|NCT01124045|B2|Baseline|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348438|NCT01124045|B1|Baseline|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348439|NCT01124045|P2|Participant Flow|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348440|NCT01124045|P1|Participant Flow|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348441|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348442|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348443|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348444|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348445|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348446|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348447|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348448|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348449|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348450|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348451|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348452|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348453|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348454|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348455|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348456|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348457|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348458|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348506|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
348459|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348460|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348461|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348462|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348463|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348464|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348465|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348466|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348467|NCT01124045|E2|Reported Event|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348468|NCT01124045|E1|Reported Event|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
348469|NCT01124006|B4|Baseline|Total|Total of all reporting groups
348470|NCT01124006|B3|Baseline|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
348471|NCT01124006|B2|Baseline|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
348472|NCT01124006|B1|Baseline|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
348473|NCT01124006|P3|Participant Flow|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
348474|NCT01124006|P2|Participant Flow|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
348475|NCT01124006|P1|Participant Flow|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
348476|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
348477|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
348478|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
348479|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
348480|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
348481|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
352918|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
348482|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
348483|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
348484|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
348485|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
348486|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
348487|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
348488|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
348489|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
348490|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
348491|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
348492|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
348493|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
348494|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
348495|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
348496|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
348497|NCT01124006|E3|Reported Event|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
348498|NCT01124006|E2|Reported Event|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
348499|NCT01124006|E1|Reported Event|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
348500|NCT01123980|B3|Baseline|Total|Total of all reporting groups
348501|NCT01123980|B2|Baseline|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
348502|NCT01123980|B1|Baseline|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
348503|NCT01123980|P2|Participant Flow|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
348504|NCT01123980|P1|Participant Flow|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
348505|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
349127|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
348507|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
348508|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
348509|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
348510|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
348511|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
348512|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
348513|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
348514|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
348515|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
348516|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
348517|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
348518|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
348519|NCT01123980|E2|Reported Event|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
348520|NCT01123980|E1|Reported Event|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
348521|NCT01123941|B3|Baseline|Total|Total of all reporting groups
348522|NCT01123941|B2|Baseline|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
348523|NCT01123941|B1|Baseline|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
348524|NCT01123941|P2|Participant Flow|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
348525|NCT01123941|P1|Participant Flow|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
348526|NCT01123941|O2|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
348527|NCT01123941|O1|Outcome|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
348528|NCT01123941|O2|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
348529|NCT01123941|O1|Outcome|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
348530|NCT01123941|O2|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
348531|NCT01123941|O1|Outcome|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
348532|NCT01123941|O2|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
348533|NCT01123941|O1|Outcome|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
348534|NCT01123941|E2|Reported Event|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
348535|NCT01123941|E1|Reported Event|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
348536|NCT01123928|B3|Baseline|Total|Total of all reporting groups
348537|NCT01123928|B2|Baseline|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
348538|NCT01123928|B1|Baseline|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
348539|NCT01123928|P2|Participant Flow|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
348540|NCT01123928|P1|Participant Flow|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
348541|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
348542|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
348543|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
348651|NCT01123161|O1|Outcome|Group1: IV t-PA and Normothermia|"IV tpa and normothermia~Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
348544|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
348545|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
348546|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
348547|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
348548|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
348549|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
348550|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
348551|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
348552|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
348553|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
348554|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
348555|NCT01123928|E2|Reported Event|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
348556|NCT01123928|E1|Reported Event|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
348557|NCT01123889|B3|Baseline|Total|Total of all reporting groups
348558|NCT01123889|B2|Baseline|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space~platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
348559|NCT01123889|B1|Baseline|Control|"corticosteroid injection into subacromial space~corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
348560|NCT01123889|P2|Participant Flow|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space~platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
348561|NCT01123889|P1|Participant Flow|Control|"corticosteroid injection into subacromial space~corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
348562|NCT01123889|O2|Outcome|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space~platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
348563|NCT01123889|O1|Outcome|Control|"corticosteroid injection into subacromial space~corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
348564|NCT01123889|O2|Outcome|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space~platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
349216|NCT01122160|O2|Outcome|Placebo|
349217|NCT01122160|O1|Outcome|Experimental|
348565|NCT01123889|O1|Outcome|Control|"corticosteroid injection into subacromial space~corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
348566|NCT01123889|O2|Outcome|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space~platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
348567|NCT01123889|O1|Outcome|Control|"corticosteroid injection into subacromial space~corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
348568|NCT01123889|E2|Reported Event|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space~platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
348569|NCT01123889|E1|Reported Event|Control|"corticosteroid injection into subacromial space~corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
348570|NCT01123850|B1|Baseline|Single ARM - Copios Bone Filler|"All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study.~Copios: Bone Void Filler"
348571|NCT01123850|P1|Participant Flow|Single ARM - Copios Bone Filler|"All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study.~Copios: Bone Void Filler"
348572|NCT01123850|O1|Outcome|Single ARM - Copios Bone Filler|"All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study.~Copios: Bone Void Filler"
348573|NCT01123850|O1|Outcome|Single ARM - Copios Bone Filler|"All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study.~Copios: Bone Void Filler"
348574|NCT01123850|E1|Reported Event|Single ARM - Copios Bone Filler|"All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study.~Copios: Bone Void Filler"
348575|NCT01123642|B1|Baseline|OEF/OIF/OND Veterans|Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
348576|NCT01123642|P1|Participant Flow|OEF/OIF/OND Veterans|Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
348577|NCT01123642|O1|Outcome|OEF/OIF/OND Veterans|Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
348578|NCT01123642|E1|Reported Event|OEF/OIF/OND Veterans|Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
348579|NCT01123512|B3|Baseline|Total|Total of all reporting groups
348580|NCT01123512|B2|Baseline|Balloon Kyphoplasty|The balloon kyphoplasty procedure involved placing an inflatable bone tamp into the vertebral body that was then inflated under fluoroscopic guidance to create a void. This void was then filled with PMMA.
348581|NCT01123512|B1|Baseline|Kiva VCF Treatment System|The Kiva® VCF Treatment System is a multi-component, single-use device designed for obtaining unilateral access to the vertebral body in order to deliver the Kiva Implant and bone cement to stabilize osteoporotic vertebral fractures. The Kiva procedure involved placement of the Kiva Implant into the vertebral body followed by injection of PMMA into the Kiva Implant.
348582|NCT01123512|P2|Participant Flow|Balloon Kyphoplasty|The balloon kyphoplasty procedure involved placing an inflatable bone tamp into the vertebral body that was then inflated under fluoroscopic guidance to create a void. This void was then filled with PMMA.
348583|NCT01123512|P1|Participant Flow|Kiva VCF Treatment System|The Kiva® VCF Treatment System is a multi-component, single-use device designed for obtaining unilateral access to the vertebral body in order to deliver the Kiva Implant and bone cement to stabilize osteoporotic vertebral fractures. The Kiva procedure involved placement of the Kiva Implant into the vertebral body followed by injection of PMMA into the Kiva Implant.
349218|NCT01122160|E2|Reported Event|Placebo|
349219|NCT01122160|E1|Reported Event|Experimental|
348584|NCT01123512|O2|Outcome|Balloon Kyphoplasty|The balloon kyphoplasty procedure involved placing an inflatable bone tamp into the vertebral body that was then inflated under fluoroscopic guidance to create a void. This void was then filled with PMMA.
348585|NCT01123512|O1|Outcome|Kiva VCF Treatment System|The Kiva® VCF Treatment System is a multi-component, single-use device designed for obtaining unilateral access to the vertebral body in order to deliver the Kiva Implant and bone cement to stabilize osteoporotic vertebral fractures. The Kiva procedure involved placement of the Kiva Implant into the vertebral body followed by injection of PMMA into the Kiva Implant.
348586|NCT01123512|E2|Reported Event|Balloon Kyphoplasty|Vertebral augmentation: Vertebral augmentation for one or two osteoporotic vertebral compression fractures
348587|NCT01123512|E1|Reported Event|Kiva VCF Treatment System|Vertebral augmentation: Vertebral augmentation for one or two osteoporotic vertebral compression fractures
348588|NCT01123395|B1|Baseline|Colcrys® Intact Tab and Colcrys® Dissolved in Apple Juice|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of intact Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice, following an overnight fast of at least 10 hours.
348589|NCT01123395|P2|Participant Flow|Colcrys® Dissolved in Apple Juice Then Colcrys® Intact Tab|On the morning of Day 1 subjects received one tablet of the test formulation, Colcrys® 0.6 mg, crushed and dissolved in 20 mL of apple juice after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received one dose of the reference formulation, one intact Colcrys® 0.6 mg tablet, after an overnight fast of at least 10 hours.
348590|NCT01123395|P1|Participant Flow|Colcrys® Intact Tab Then Colcrys® Dissolved in Apple Juice|On the morning of Day 1, subjects received the reference formulation, one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received the test formulation, one Colcrys® 0.6 mg tablet crushed and dissolved in 20 mL of apple juice, after an overnight fast of at least 10 hours
348591|NCT01123395|O2|Outcome|Colcrys® 0.6 mg Tablet Crushed and Dissolved in Apple Juice|Each subject received one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice after an overnight fast of at least 10 hours
348592|NCT01123395|O1|Outcome|Colcrys® 0.6 mg Administered as an Intact Tablet|Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
348593|NCT01123395|O2|Outcome|Colcrys® 0.6 mg Tablet Crushed and Dissolved in Apple Juice|Each subject received one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice after an overnight fast of at least 10 hours
348594|NCT01123395|O1|Outcome|Colcrys® 0.6 mg Administered as an Intact Tablet|Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
348595|NCT01123395|O2|Outcome|Colcrys® 0.6 mg Tablet Crushed and Dissolved in Apple Juice|Each subject received one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice after an overnight fast of at least 10 hours
348596|NCT01123395|O1|Outcome|Colcrys® 0.6 mg Administered as an Intact Tablet|Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
348597|NCT01123395|E2|Reported Event|Colcrys® 0.6 mg Tablet Crushed and Dissolved in Apple Juice|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one intact tablet of Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice, following an overnight fast of at least 10 hours.
348598|NCT01123395|E1|Reported Event|Colcrys® 0.6 mg Tablet Administered Intact|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one intact tablet of Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice, following an overnight fast of at least 10 hours.
348599|NCT01123382|B3|Baseline|Total|Total of all reporting groups
348600|NCT01123382|B2|Baseline|Usual Care (UC)|"The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.~Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant."
348601|NCT01123382|B1|Baseline|IM Electrical Stimulation (IM ES)|"The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.~Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed."
348602|NCT01123382|P2|Participant Flow|Usual Care (UC)|"The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.~Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant."
348603|NCT01123382|P1|Participant Flow|IM Electrical Stimulation (IM ES)|"The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.~Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed."
352919|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
348604|NCT01123382|O2|Outcome|Usual Care (UC)|"The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.~Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant."
348605|NCT01123382|O1|Outcome|IM Electrical Stimulation (IM ES)|"The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.~Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed."
348606|NCT01123382|O2|Outcome|Usual Care (UC)|"The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.~Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant."
348607|NCT01123382|O1|Outcome|IM Electrical Stimulation (IM ES)|"The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.~Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed."
348608|NCT01123382|O2|Outcome|Usual Care (UC)|"The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.~Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant."
348609|NCT01123382|O1|Outcome|IM Electrical Stimulation (IM ES)|"The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.~Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed."
348610|NCT01123382|O2|Outcome|Usual Care (UC)|"The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.~Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant."
348611|NCT01123382|O1|Outcome|IM Electrical Stimulation (IM ES)|"The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.~Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed."
348612|NCT01123382|O2|Outcome|Usual Care (UC)|"The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.~Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant."
348613|NCT01123382|O1|Outcome|IM Electrical Stimulation (IM ES)|"The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.~Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed."
348614|NCT01123382|O2|Outcome|Usual Care (UC)|"The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.~Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant."
352920|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
348615|NCT01123382|O1|Outcome|IM Electrical Stimulation (IM ES)|"The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.~Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed."
348616|NCT01123382|O2|Outcome|Usual Care (UC)|"The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.~Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant."
348617|NCT01123382|O1|Outcome|IM Electrical Stimulation (IM ES)|"The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.~Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed."
348618|NCT01123382|O2|Outcome|Usual Care (UC)|"The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.~Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant."
348619|NCT01123382|O1|Outcome|IM Electrical Stimulation (IM ES)|"The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.~Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed."
348620|NCT01123382|O2|Outcome|Usual Care (UC)|"The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.~Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant."
348621|NCT01123382|O1|Outcome|IM Electrical Stimulation (IM ES)|"The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.~Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed."
348622|NCT01123382|E2|Reported Event|Usual Care (UC)|"The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.~Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant."
348623|NCT01123382|E1|Reported Event|IM Electrical Stimulation (IM ES)|"The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.~Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed."
348624|NCT01123356|B1|Baseline|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles"
348625|NCT01123356|P1|Participant Flow|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles"
348652|NCT01123161|O2|Outcome|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment~hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming"
348626|NCT01123356|O1|Outcome|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles~Ofatumumab: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)~-Treatment to be administered for up to 6 cycles~Lenalidomide: -Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)"
348627|NCT01123356|O1|Outcome|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles~Ofatumumab: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)~-Treatment to be administered for up to 6 cycles~Lenalidomide: -Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)"
348628|NCT01123356|O1|Outcome|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles~Ofatumumab: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)~-Treatment to be administered for up to 6 cycles~Lenalidomide: -Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)"
348629|NCT01123356|O1|Outcome|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles~Ofatumumab: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)~-Treatment to be administered for up to 6 cycles~Lenalidomide: -Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)"
348630|NCT01123356|O1|Outcome|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles"
348631|NCT01123356|E1|Reported Event|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles"
348632|NCT01123200|B1|Baseline|Brain Computer Interface In-Home Use|Brain Computer Interface for Wheelchair Tilt Control: Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
348633|NCT01123200|P1|Participant Flow|Brain Computer Interface In-Home Use|Brain Computer Interface for Wheelchair Tilt Control: Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
348634|NCT01123200|O1|Outcome|Brain Computer Interface In-Home Use|Brain Computer Interface for Wheelchair Tilt Control: Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
348635|NCT01123200|O1|Outcome|Brain Computer Interface In-Home Use|Brain Computer Interface for Wheelchair Tilt Control: Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
348636|NCT01123200|E1|Reported Event|Brain Computer Interface In-Home Use|Brain Computer Interface for Wheelchair Tilt Control: Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
348637|NCT01123161|B3|Baseline|Total|Total of all reporting groups
348638|NCT01123161|B2|Baseline|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment~hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming"
348639|NCT01123161|B1|Baseline|Group1: IV t-PA and Normothermia|"IV tpa and normothermia~Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
348640|NCT01123161|P2|Participant Flow|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment~hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming."
348641|NCT01123161|P1|Participant Flow|Group1: IV t-PA and Normothermia|"IV tpa and normothermia~Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
348642|NCT01123161|O2|Outcome|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment~hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming"
348643|NCT01123161|O1|Outcome|Group1: IV t-PA and Normothermia|"IV tpa and normothermia~Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
348644|NCT01123161|O2|Outcome|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia~hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering treatment includes buspirone, meperidine, and surface warming."
348645|NCT01123161|O1|Outcome|Group1: IV t-PA and Normothermia|"IV tpa and normothermia~Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
348646|NCT01123161|O2|Outcome|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment~hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming."
348647|NCT01123161|O1|Outcome|Group1: IV t-PA and Normothermia|"IV tpa and normothermia~Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
348648|NCT01123161|O2|Outcome|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment~hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming"
348649|NCT01123161|O1|Outcome|Group1: IV t-PA and Normothermia|"IV tpa and normothermia~Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
348650|NCT01123161|O2|Outcome|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment~hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming"
350639|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
348653|NCT01123161|O1|Outcome|Group1: IV t-PA and Normothermia|"IV tpa and normothermia~Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
348654|NCT01123161|O2|Outcome|Group 2 : IV t-PA and Hypothermia|"IV tpa and hypothermia~hypothermia: Hypothermia is induced using the Celsius Control™ System"
348655|NCT01123161|O1|Outcome|Group1: IV t-PA and Normothermia|"IV tpa and normothermia~Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
348656|NCT01123161|E2|Reported Event|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment~hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine and surface warming."
348657|NCT01123161|E1|Reported Event|Group1: IV t-PA and Normothermia|"IV tpa and normothermia~Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
348658|NCT01123148|B1|Baseline|Tilt Testing|Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
348659|NCT01123148|P1|Participant Flow|Tilt Testing|Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
348660|NCT01123148|O1|Outcome|Tilt Testing|Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
348661|NCT01123148|E1|Reported Event|Tilt Testing|Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
348662|NCT01123083|B3|Baseline|Total|Total of all reporting groups
348663|NCT01123083|B2|Baseline|Otelixizumab|Eligible participants received otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
348664|NCT01123083|B1|Baseline|Placebo|Eligible participants received Placebo matching otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
348665|NCT01123083|P2|Participant Flow|Otelixizumab|Eligible participants received otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
348666|NCT01123083|P1|Participant Flow|Placebo|Eligible participants received Placebo matching otelixizumab 3.1 milligrams (mg) as intravenous (IV) infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
348667|NCT01123083|O2|Outcome|Otelixizumab|Eligible participants received otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
348668|NCT01123083|O1|Outcome|Placebo|Eligible participants received Placebo matching otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
348669|NCT01123083|O2|Outcome|Otelixizumab|Eligible participants received otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
348670|NCT01123083|O1|Outcome|Placebo|Eligible participants received Placebo matching otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
348671|NCT01123083|O2|Outcome|Otelixizumab|Eligible participants received otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
348672|NCT01123083|O1|Outcome|Placebo|Eligible participants received Placebo matching otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
348673|NCT01123083|O2|Outcome|Otelixizumab|Eligible participants received otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
348674|NCT01123083|O1|Outcome|Placebo|Eligible participants received Placebo matching otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
348675|NCT01123083|O2|Outcome|Otelixizumab|Eligible participants received otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
348676|NCT01123083|O1|Outcome|Placebo|Eligible participants received Placebo matching otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
348677|NCT01123083|O2|Outcome|Otelixizumab|Eligible participants received otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
348678|NCT01123083|O1|Outcome|Placebo|Eligible participants received Placebo matching otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
348679|NCT01123083|O2|Outcome|Otelixizumab|Eligible participants received otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
348680|NCT01123083|O1|Outcome|Placebo|Eligible participants received Placebo matching otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
348681|NCT01123083|O2|Outcome|Otelixizumab|Eligible participants received otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
350640|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
348682|NCT01123083|O1|Outcome|Placebo|Eligible participants received Placebo matching otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
348683|NCT01123083|O2|Outcome|Otelixizumab|Eligible participants received otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
348684|NCT01123083|O1|Outcome|Placebo|Eligible participants received Placebo matching otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
348685|NCT01123083|O2|Outcome|Otelixizumab|Eligible participants received otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
348686|NCT01123083|O1|Outcome|Placebo|Eligible participants received Placebo matching otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
348687|NCT01123083|E2|Reported Event|Otelixizumab|Eligible participants received otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
348688|NCT01123083|E1|Reported Event|Placebo|Eligible participants received Placebo matching otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
348689|NCT01122927|B1|Baseline|All Study Participants|Participants who entered open-label treatment phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348690|NCT01122927|P2|Participant Flow|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348691|NCT01122927|P1|Participant Flow|Conversion Phase|Participants who entered this phase were converted from his or her antipsychotic to the minimum target dose of 10 mg/day aripiprazole monotherapy and continued to increase the dose up to a maximum of 30 mg/day, or for tolerability reasons, to reduce the aripiprazole dose to no less than 5 mg/day.
348692|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348693|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348694|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348695|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348696|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348697|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348698|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348699|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348700|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348701|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348702|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348703|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348704|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348705|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348706|NCT01122927|O5|Outcome|Tanner Score at Baseline of 5|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348707|NCT01122927|O4|Outcome|Tanner Score at Baseline of 4|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348745|NCT01122862|P1|Participant Flow|Test Mouth Rinse|Participants swirled their oral cavity with 15 milliliters (mL) of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
348708|NCT01122927|O3|Outcome|Tanner Score at Baseline of 3|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348709|NCT01122927|O2|Outcome|Tanner Score at Baseline of 2|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348710|NCT01122927|O1|Outcome|Tanner Score at Baseline of 1|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348711|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348712|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348713|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348714|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348715|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348716|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348717|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348718|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348719|NCT01122927|E2|Reported Event|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
348720|NCT01122927|E1|Reported Event|Conversion Phase|Participants who entered this phase were converted from his or her antipsychotic to the minimum target dose of 10 mg/day aripiprazole monotherapy and continue to increase the dose up to a maximum of 30 mg/day, or for tolerability reasons, to reduce the aripiprazole dose to no less than 5 mg/day.
348721|NCT01122901|B3|Baseline|Total|Total of all reporting groups
348722|NCT01122901|B2|Baseline|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
348723|NCT01122901|B1|Baseline|Group A RO4929097 PO|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~pharmacological study: Correlative studies"
348724|NCT01122901|P2|Participant Flow|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
348725|NCT01122901|P1|Participant Flow|Group A RO4929097 PO|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~pharmacological study: Correlative studies"
348726|NCT01122901|O3|Outcome|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
348727|NCT01122901|O2|Outcome|Group A RO4929097 PO|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~pharmacological study: Correlative studies"
348728|NCT01122901|O1|Outcome|Group A (Post Surgery) & Group B (Pre-surgery) RO4929097 PO|"GROUP A Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~pharmacological study: Correlative studies~GROUP B Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
349569|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
348729|NCT01122901|O1|Outcome|Group B (Gamma-secretase Inhibitor RO4929097, Surgery)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
348730|NCT01122901|O1|Outcome|Group B (Gamma-secretase Inhibitor RO4929097, Surgery)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
348731|NCT01122901|O2|Outcome|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
348732|NCT01122901|O1|Outcome|Group A (Post Surgery) RO4929097 PO|"GROUP A Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~pharmacological study: Correlative studies~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
348733|NCT01122901|O2|Outcome|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
348734|NCT01122901|O1|Outcome|Group A RO4929097 PO|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~pharmacological study: Correlative studies"
348735|NCT01122901|O2|Outcome|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
348736|NCT01122901|O1|Outcome|Group A RO4929097 PO|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~pharmacological study: Correlative studies"
348737|NCT01122901|O1|Outcome|Group B (Gamma-secretase Inhibitor RO4929097, Surgery)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
348738|NCT01122901|O2|Outcome|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
348739|NCT01122901|O1|Outcome|Group A (Post Surgery) & Group B (Pre-surgery) RO4929097 PO|"GROUP A Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~pharmacological study: Correlative studies~GROUP B Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
348740|NCT01122901|E2|Reported Event|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
348741|NCT01122901|E1|Reported Event|Group A RO4929097 PO|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~pharmacological study: Correlative studies"
348742|NCT01122862|B1|Baseline|All Randomized Participants|All randomized participants were included for baseline parameters evaluation.
348743|NCT01122862|P3|Participant Flow|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
348744|NCT01122862|P2|Participant Flow|Chlorhexidine Mouth Rinse (0.12%)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% weight by volume (w/v) chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
348746|NCT01122862|O3|Outcome|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
348747|NCT01122862|O2|Outcome|Chlorhexidine Mouth Rinse (0.12% w/v)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% w/v chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
348748|NCT01122862|O1|Outcome|Test Mouth Rinse|Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
348749|NCT01122862|O3|Outcome|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
348750|NCT01122862|O2|Outcome|Chlorhexidine Mouth Rinse (0.12% w/v)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% w/v chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
348751|NCT01122862|O1|Outcome|Test Mouth Rinse|Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
348752|NCT01122862|O3|Outcome|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
348753|NCT01122862|O2|Outcome|Chlorhexidine Mouth Rinse (0.12% w/v)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% w/v chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
348754|NCT01122862|O1|Outcome|Test Mouth Rinse|Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
348755|NCT01122862|O2|Outcome|Chlorhexidine Mouth Rinse (0.12% w/v)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% w/v chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
348756|NCT01122862|O1|Outcome|Test Mouth Rinse|Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
348757|NCT01122862|O2|Outcome|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
348758|NCT01122862|O1|Outcome|Test Mouth Rinse|Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
348759|NCT01122862|E3|Reported Event|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
348760|NCT01122862|E2|Reported Event|Chlorhexidine Mouth Rinse (0.12% w/v)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% w/v chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
348761|NCT01122862|E1|Reported Event|Test Mouth Rinse|Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
348762|NCT01122849|B4|Baseline|Total|Total of all reporting groups
348763|NCT01122849|B3|Baseline|Prototype Nasal Strip|Participants applied the Prototype nasal dilator strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348764|NCT01122849|B2|Baseline|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348765|NCT01122849|B1|Baseline|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348766|NCT01122849|P3|Participant Flow|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348767|NCT01122849|P2|Participant Flow|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348768|NCT01122849|P1|Participant Flow|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348769|NCT01122849|O3|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348770|NCT01122849|O2|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348771|NCT01122849|O1|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348772|NCT01122849|O3|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348773|NCT01122849|O2|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348774|NCT01122849|O1|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348775|NCT01122849|O3|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348776|NCT01122849|O2|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348777|NCT01122849|O1|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348778|NCT01122849|O3|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348779|NCT01122849|O2|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348780|NCT01122849|O1|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348781|NCT01122849|O3|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348782|NCT01122849|O2|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348783|NCT01122849|O1|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348784|NCT01122849|O3|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348785|NCT01122849|O2|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348786|NCT01122849|O1|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348787|NCT01122849|O3|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348788|NCT01122849|O2|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348789|NCT01122849|O1|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348790|NCT01122849|O3|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal dilator strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348877|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348791|NCT01122849|O2|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348792|NCT01122849|O1|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant
348793|NCT01122849|O3|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348794|NCT01122849|O2|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348795|NCT01122849|O1|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348796|NCT01122849|O3|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348797|NCT01122849|O2|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348798|NCT01122849|O1|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348799|NCT01122849|O3|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348800|NCT01122849|O2|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348801|NCT01122849|O1|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348802|NCT01122849|O3|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348803|NCT01122849|O2|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348804|NCT01122849|O1|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348805|NCT01122849|O3|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348806|NCT01122849|O2|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant
348807|NCT01122849|O1|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348808|NCT01122849|O3|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348809|NCT01122849|O2|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348878|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348810|NCT01122849|O1|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348811|NCT01122849|O3|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348812|NCT01122849|O2|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348813|NCT01122849|O1|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348814|NCT01122849|O3|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348815|NCT01122849|O2|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348816|NCT01122849|O1|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions to be provided. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348817|NCT01122849|O3|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal dilator strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348818|NCT01122849|O2|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348819|NCT01122849|O1|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348820|NCT01122849|O3|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348821|NCT01122849|O2|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348822|NCT01122849|O1|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348823|NCT01122849|O3|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348824|NCT01122849|O2|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348825|NCT01122849|O1|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348826|NCT01122849|O3|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348827|NCT01122849|O2|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348828|NCT01122849|O1|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348879|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
350641|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
348829|NCT01122849|O3|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348830|NCT01122849|O2|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348831|NCT01122849|O1|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348832|NCT01122849|O3|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal dilator strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348833|NCT01122849|O2|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348834|NCT01122849|O1|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348835|NCT01122849|O3|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348836|NCT01122849|O2|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348837|NCT01122849|O1|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348838|NCT01122849|O3|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal dilator strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348839|NCT01122849|O2|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348840|NCT01122849|O1|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348841|NCT01122849|O3|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. The strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348842|NCT01122849|O2|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. The strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348843|NCT01122849|O1|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. The strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348844|NCT01122849|O3|Outcome|Prototype Nasal Strip|Participants applied the Prototype nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348845|NCT01122849|O2|Outcome|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348846|NCT01122849|O1|Outcome|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348847|NCT01122849|E3|Reported Event|Prototype Nasal Dilator|Participants applied the Prototype nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348880|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
350642|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
348848|NCT01122849|E2|Reported Event|Placebo Nasal Strip|Participants applied the Placebo nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348849|NCT01122849|E1|Reported Event|Marketed Nasal Strip|Participants applied the Marketed nasal strips according to written instructions. A member of the site staff reviewed the instructions for administration with each participant. Strips were applied every night during the treatment phase of the study. All treatments in this study were self-administered by the participant.
348850|NCT01122680|B1|Baseline|Total.|Total number of patients randomised and treated at all in the study.
348851|NCT01122680|P4|Participant Flow|Tio R2.5/Tio R1.25/Placebo|Patients treated with Tiotropium 2.5 mcg in Phase I, with Tiotropium 1.25 mcg in Phase II and with a matching Placebo in Phase III. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off-treatment periods) between treatments.
348852|NCT01122680|P3|Participant Flow|Placebo/Tio R2.5/Tio R5|Patients treated with a matching Placebo in Phase I, with Tiotropium 2.5 mcg in Phase II and with Tiotropium 5 mcg in Phase III. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off-treatment periods) between treatments.
348853|NCT01122680|P2|Participant Flow|Tio R1.25/Tio R5/Tio R2.5|Patients treated with Tiotropium 1.25 mcg in Phase I, with Tiotropium 5 mcg in Phase II and with Tiotropium 2.5 mcg in Phase III. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off-treatment periods) between treatments.
348854|NCT01122680|P1|Participant Flow|Tio R5/Placebo/Tio R1.25|Patients treated with Tiotropium 5 mcg in Phase I, with a matching Placebo in Phase II and with Tiotropium 1.25 mcg in Phase III. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off-treatment periods) between treatments.
348855|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348856|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348857|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348858|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348859|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348860|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348861|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348862|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348863|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348864|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348865|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348866|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348867|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348868|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348869|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348870|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348871|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348872|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348873|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348874|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348875|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348876|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348881|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348882|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348883|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348884|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348885|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348886|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348887|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348888|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348889|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348890|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348891|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348892|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348893|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348894|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348895|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348896|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348897|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348898|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348899|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348900|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348901|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348902|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348903|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348904|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348905|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348906|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348907|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348908|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348909|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348910|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348911|NCT01122680|E4|Reported Event|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348912|NCT01122680|E3|Reported Event|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348913|NCT01122680|E2|Reported Event|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
350643|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
348914|NCT01122680|E1|Reported Event|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
348915|NCT01122576|B4|Baseline|Total|Total of all reporting groups
348916|NCT01122576|B3|Baseline|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348917|NCT01122576|B2|Baseline|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
348918|NCT01122576|B1|Baseline|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
348919|NCT01122576|P3|Participant Flow|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL :Tecnis surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days."
348920|NCT01122576|P2|Participant Flow|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days."
348921|NCT01122576|P1|Participant Flow|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days."
348922|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348923|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
348924|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
348925|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348926|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
348927|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
348928|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348929|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
348930|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
348931|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348932|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
348933|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
348934|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348935|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
348936|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
348937|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348938|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
348939|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
348940|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348941|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
349570|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
348942|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
348943|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348944|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
348945|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
348946|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348947|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
348948|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
348949|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348950|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
348951|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
348952|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348953|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
348954|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
348955|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348956|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
348957|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
348958|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348959|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
348960|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
348961|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348962|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
348963|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
348964|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348965|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
348966|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
348967|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348968|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
348969|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
348970|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348971|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
348972|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
348973|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348974|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
348975|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
348976|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348977|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
348978|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
348979|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348980|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
348981|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
348982|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348983|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
348984|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
348985|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348986|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
348987|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
348988|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348989|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
348990|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
348991|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348992|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
348993|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
348994|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348995|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
348996|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
348997|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
348998|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
348999|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
349000|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
349001|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
349002|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
349003|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
349004|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
349005|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
349006|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
349007|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
349008|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
349009|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
349010|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
349011|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
349012|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
349013|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
349014|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
349015|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
349016|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
349017|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
349018|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
349019|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
349020|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
349021|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
349022|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
349023|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
349024|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
349025|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
349026|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
349027|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
349028|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and wer implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
349029|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
349030|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
349031|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
349032|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
349033|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
349034|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
349035|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
349036|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
349037|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
349038|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
349039|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
349040|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
349041|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
349042|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
349043|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
349044|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
349045|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
349046|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
349047|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
349048|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
349049|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
349050|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
349051|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
349052|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
349053|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
349054|NCT01122576|E3|Reported Event|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
349055|NCT01122576|E2|Reported Event|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
349056|NCT01122576|E1|Reported Event|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
349057|NCT01122511|B3|Baseline|Total|Total of all reporting groups
349058|NCT01122511|B2|Baseline|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
349059|NCT01122511|B1|Baseline|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
349060|NCT01122511|P2|Participant Flow|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
349061|NCT01122511|P1|Participant Flow|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
349062|NCT01122511|O2|Outcome|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
349063|NCT01122511|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
349064|NCT01122511|O2|Outcome|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
349065|NCT01122511|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
349066|NCT01122511|O2|Outcome|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
349067|NCT01122511|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
349068|NCT01122511|O2|Outcome|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
349069|NCT01122511|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
349070|NCT01122511|E2|Reported Event|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
349071|NCT01122511|E1|Reported Event|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
349072|NCT01122394|B3|Baseline|Total|Total of all reporting groups
349073|NCT01122394|B2|Baseline|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
349074|NCT01122394|B1|Baseline|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
349075|NCT01122394|P2|Participant Flow|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
349076|NCT01122394|P1|Participant Flow|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
349077|NCT01122394|O2|Outcome|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
349078|NCT01122394|O1|Outcome|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
349079|NCT01122394|O2|Outcome|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
349080|NCT01122394|O1|Outcome|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
349081|NCT01122394|O2|Outcome|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
349082|NCT01122394|O1|Outcome|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
349083|NCT01122394|O2|Outcome|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
349084|NCT01122394|O1|Outcome|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
349085|NCT01122394|O2|Outcome|Attention Placebo (AP)|"Attention Placebo~AP: Attention placebo"
349086|NCT01122394|O1|Outcome|Tailored Intervention (TI)|"Tailored intervention based on the transtheoretical model~TI: Tailored intervention based on the transtheoretical model"
349087|NCT01122394|E2|Reported Event|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
349088|NCT01122394|E1|Reported Event|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
349089|NCT01122381|B3|Baseline|Total|Total of all reporting groups
349090|NCT01122381|B2|Baseline|Arm 2|"placebo same size blinded capsules as the 250mg ESX; similar titration up to 4 capsules qd (expected) or 5 or 6 capsules for efficacy (not to exceed 30mg/kg/d) vs maximum tolerability~placebo comparator: placebo same size blinded capsules as the 250mg ESX; similar titration up to 4 capsules qd (expected) or 5 or 6 capsules for efficacy (not to exceed 30mg/kg/d) vs maximum tolerability"
349091|NCT01122381|B1|Baseline|Arm 1|"migraineurs with 4-14 headache days per month that meet all inclusion/exclusion criteria~ethosuximide: ethosuximide (ESX) 250mg blinded capsules; begin 250mg qd titrating up to 1000mg qd (expected) or 1250mg qd, or 1500mg qd /30mg/kg/d maximum for efficacy goal of < 50% reduction in headache days versus maximum tolerability"
349092|NCT01122381|P2|Participant Flow|Arm 2-placebo|"migraineurs with 4-14 headache days per month that meet all inclusion/exclusion criteria~placebo comparator: placebo same size blinded capsules as the 250mg ESX; similar titration up to 4 capsules qd (expected) or 5 or 6 capsules for efficacy (not to exceed 30mg/kg/d) vs maximum tolerability"
349126|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349093|NCT01122381|P1|Participant Flow|Arm 1-drug Treatment|"migraineurs with 4-14 headache days per month that meet all inclusion/exclusion criteria~ethosuximide: ethosuximide (ESX) 250mg blinded capsules; begin 250mg qd titrating up to 1000mg qd (expected) or 1250mg qd, or 1500mg qd /30mg/kg/d maximum for efficacy goal of < 50% reduction in headache days versus maximum tolerability"
349094|NCT01122381|O2|Outcome|Arm 2-placebo Comparator|Study was terminated early-no outcome data available. Only one subject was assigned to study placebo but was dis-enrolled after titration phase due to study termination.
349095|NCT01122381|O1|Outcome|Arm 1-ethosuximide|Study was terminated early-no outcome data available. Only one subject was assigned to study drug arm but did not actually take it according to subsequent review of ESX drug levels.
349096|NCT01122381|E2|Reported Event|Arm 2- Placebo Comparator|"placebo blinded capsules of 250mg; subject was titrated up to 4 capsules qd"
349097|NCT01122381|E1|Reported Event|Arm 1- Ethosuximide|ethosuximide blinded capsules of 250mg ESX; subject was titrated up to 4 capsules qd
349098|NCT01122264|B4|Baseline|Total|Total of all reporting groups
349099|NCT01122264|B3|Baseline|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349100|NCT01122264|B2|Baseline|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
349101|NCT01122264|B1|Baseline|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349102|NCT01122264|P3|Participant Flow|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349103|NCT01122264|P2|Participant Flow|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
349104|NCT01122264|P1|Participant Flow|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349105|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349106|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
349107|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349108|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349109|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
349110|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349111|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349112|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
349113|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349114|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349115|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
349116|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349117|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349118|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
349119|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349120|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349121|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
349122|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349123|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349124|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
349125|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349128|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349129|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day).
349130|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tadalafil tablet orally, once a day.
349131|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day).
349132|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349133|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
349134|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349135|NCT01122264|O1|Outcome|Entire Study Population|"Tadalafil On Demand: Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day).~Tadalafil Once a Day: Participants were instructed to take a 5-mg or 2.5-mg tadalafil tablet orally, once a day.~Sildenafil Citrate On Demand: Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day)."
349136|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349137|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
349138|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349139|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349140|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
349141|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349142|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349143|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
349144|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349145|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349146|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
349147|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349148|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349149|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
349150|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349151|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349152|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
349153|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349154|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349155|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
349156|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349157|NCT01122264|E3|Reported Event|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349158|NCT01122264|E2|Reported Event|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
352921|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
349159|NCT01122264|E1|Reported Event|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
349160|NCT01122238|B17|Baseline|Total|Total of all reporting groups
349161|NCT01122238|B16|Baseline|16, No Nicotine Patch, No Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
349162|NCT01122238|B15|Baseline|15, No Nicotine Patch, No Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
349163|NCT01122238|B14|Baseline|14, No Nicotine Patch, No Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
349164|NCT01122238|B13|Baseline|13, No Nicotine Patch, No Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
349165|NCT01122238|B12|Baseline|12, No Nicotine Patch, Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
349166|NCT01122238|B11|Baseline|11, No Nicotine Patch, Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
349167|NCT01122238|B10|Baseline|10, No Nicotine Patch, Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
349168|NCT01122238|B9|Baseline|9, No Nicotine Patch, Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
349169|NCT01122238|B8|Baseline|8, Nicotine Patch, No Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
349170|NCT01122238|B7|Baseline|7, Nicotine Patch, No Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
349171|NCT01122238|B6|Baseline|6, Nicotine Patch, No Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
349172|NCT01122238|B5|Baseline|5, Nicotine Patch, No Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
349173|NCT01122238|B4|Baseline|4, Nicotine Patch, Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
349174|NCT01122238|B3|Baseline|3, Nicotine Patch, Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
349175|NCT01122238|B2|Baseline|2, Nicotine Patch, Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
349176|NCT01122238|B1|Baseline|1, Nicotine Patch, Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
349177|NCT01122238|P16|Participant Flow|16, No Nicotine Patch, No Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
349178|NCT01122238|P15|Participant Flow|15, No Nicotine Patch, No Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
349179|NCT01122238|P14|Participant Flow|14, No Nicotine Patch, No Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
349180|NCT01122238|P13|Participant Flow|13, No Nicotine Patch, No Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
349181|NCT01122238|P12|Participant Flow|12, No Nicotine Patch, Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
349182|NCT01122238|P11|Participant Flow|11, No Nicotine Patch, Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
349183|NCT01122238|P10|Participant Flow|10, No Nicotine Patch, Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
349258|NCT01122030|O5|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349184|NCT01122238|P9|Participant Flow|9, No Nicotine Patch, Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
349185|NCT01122238|P8|Participant Flow|8, Nicotine Patch, No Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
349186|NCT01122238|P7|Participant Flow|7, Nicotine Patch, No Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
349187|NCT01122238|P6|Participant Flow|6, Nicotine Patch, No Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
349188|NCT01122238|P5|Participant Flow|5, Nicotine Patch, No Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
349189|NCT01122238|P4|Participant Flow|4, Nicotine Patch, Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
349190|NCT01122238|P3|Participant Flow|3, Nicotine Patch, Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
349191|NCT01122238|P2|Participant Flow|2, Nicotine Patch, Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
349192|NCT01122238|P1|Participant Flow|1, Nicotine Patch, Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
349193|NCT01122238|O8|Outcome|No Motivational Interviewing|All participants in this group received No Motivational Interviewing counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Smoking Reduction or No Smoking Reduction). The No Motivational Interviewing group consists of 264 participants (approximately half of the total study sample) and will be compared to a corresponding Motivational Interviewing group consisting of 253 participants (approximately half of the total study sample) in a main effect (Motivational Interviewing versus No Motivational Interviewing) statistical comparison.
349194|NCT01122238|O7|Outcome|Motivational Interviewing|All participants in this group received Motivational Interviewing counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Smoking Reduction or No Smoking Reduction). The Motivational Interviewing group consists of 253 participants (approximately half of the total study sample) and will be compared to a corresponding No Motivational Interviewing group consisting of 264 participants (approximately half of the total study sample) in a main effect (Motivational Interviewing versus No Motivational Interviewing) statistical comparison.
349195|NCT01122238|O6|Outcome|No Smoking Reduction|All participants in this group received No Smoking Reduction counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing). The No Smoking Reduction group consists of 257 participants (approximately half of the total study sample) and will be compared to a corresponding Smoking Reduction group consisting of 260 participants (approximately half of the total study sample) in a main effect (Smoking Reduction versus No Smoking Reduction) statistical comparison.
349196|NCT01122238|O5|Outcome|Smoking Reduction|All participants in this group received Smoking Reduction counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing). The Smoking Reduction group consists of 260 participants (approximately half of the total study sample) and will be compared to a corresponding No Smoking Reduction group consisting of 257 participants (approximately half of the total study sample) in a main effect (Smoking Reduction versus No Smoking Reduction) statistical comparison.
349197|NCT01122238|O4|Outcome|No Nicotine Gum|All participants in this group received No Nicotine Gum; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The No Nicotine Gum group consists of 253 participants (approximately half of the total study sample) and will be compared to a corresponding Nicotine Gum group consisting of 264 participants (approximately half of the total study sample) in a main effect (Nicotine Gum versus No Nicotine Gum) statistical comparison.
349198|NCT01122238|O3|Outcome|Nicotine Gum|All participants in this group received Nicotine Gum; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The Nicotine Gum group consists of 264 participants (approximately half of the total study sample) and will be compared to a corresponding No Nicotine Gum group consisting of 253 participants (approximately half of the total study sample) in a main effect (Nicotine Gum versus No Nicotine Gum) statistical comparison.
349199|NCT01122238|O2|Outcome|No Nicotine Patch|All participants in this group received No Nicotine Patch; the group includes participants who received combinations of the other three study interventions (Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The No Nicotine Patch group consists of 252 participants (approximately half of the total study sample) and will be compared to a corresponding Nicotine Patch group consisting of 265 participants (approximately half of the total study sample) in a main effect (Nicotine Patch versus No Nicotine Patch) statistical comparison.
349259|NCT01122030|O4|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349200|NCT01122238|O1|Outcome|Nicotine Patch|All participants in this group received Nicotine Patch; the group includes participants who received combinations of the other three study interventions (Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The Nicotine Patch group consists of 265 participants (approximately half of the total study sample) and will be compared to a corresponding No Nicotine Patch group consisting of 252 participants (approximately half of the total study sample) in a main effect (Nicotine Patch versus No Nicotine Patch) statistical comparison.
349201|NCT01122238|O8|Outcome|No Motivational Interviewing|All participants in this group received No Motivational Interviewing counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Smoking Reduction or No Smoking Reduction). The No Motivational Interviewing group consists of 264 participants (approximately half of the total study sample) and will be compared to a corresponding Motivational Interviewing group consisting of 253 participants (approximately half of the total study sample) in a main effect (Motivational Interviewing versus No Motivational Interviewing) statistical comparison.
349202|NCT01122238|O7|Outcome|Motivational Interviewing|All participants in this group received Motivational Interviewing counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Smoking Reduction or No Smoking Reduction). The Motivational Interviewing group consists of 253 participants (approximately half of the total study sample) and will be compared to a corresponding No Motivational Interviewing group consisting of 264 participants (approximately half of the total study sample) in a main effect (Motivational Interviewing versus No Motivational Interviewing) statistical comparison.
349203|NCT01122238|O6|Outcome|No Smoking Reduction|All participants in this group received No Smoking Reduction counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing). The No Smoking Reduction group consists of 257 participants (approximately half of the total study sample) and will be compared to a corresponding Smoking Reduction group consisting of 260 participants (approximately half of the total study sample) in a main effect (Smoking Reduction versus No Smoking Reduction) statistical comparison.
349204|NCT01122238|O5|Outcome|Smoking Reduction|All participants in this group received Smoking Reduction counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing). The Smoking Reduction group consists of 260 participants (approximately half of the total study sample) and will be compared to a corresponding No Smoking Reduction group consisting of 257 participants (approximately half of the total study sample) in a main effect (Smoking Reduction versus No Smoking Reduction) statistical comparison.
349205|NCT01122238|O4|Outcome|No Nicotine Gum|All participants in this group received No Nicotine Gum; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The No Nicotine Gum group consists of 253 participants (approximately half of the total study sample) and will be compared to a corresponding Nicotine Gum group consisting of 264 participants (approximately half of the total study sample) in a main effect (Nicotine Gum versus No Nicotine Gum) statistical comparison.
349206|NCT01122238|O3|Outcome|Nicotine Gum|All participants in this group received Nicotine Gum; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The Nicotine Gum group consists of 264 participants (approximately half of the total study sample) and will be compared to a corresponding No Nicotine Gum group consisting of 253 participants (approximately half of the total study sample) in a main effect (Nicotine Gum versus No Nicotine Gum) statistical comparison.
349207|NCT01122238|O2|Outcome|No Nicotine Patch|All participants in this group received No Nicotine Patch; the group includes participants who received combinations of the other three study interventions (Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The No Nicotine Patch group consists of 252 participants (approximately half of the total study sample) and will be compared to a corresponding Nicotine Patch group consisting of 265 participants (approximately half of the total study sample) in a main effect (Nicotine Patch versus No Nicotine Patch) statistical comparison.
349208|NCT01122238|O1|Outcome|Nicotine Patch|All participants in this group received Nicotine Patch; the group includes participants who received combinations of the other three study interventions (Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The Nicotine Patch group consists of 265 participants (approximately half of the total study sample) and will be compared to a corresponding No Nicotine Patch group consisting of 252 participants (approximately half of the total study sample) in a main effect (Nicotine Patch versus No Nicotine Patch) statistical comparison.
349209|NCT01122238|E4|Reported Event|No Medication|"No Medication~Participants randomized to this condition received no medication."
349210|NCT01122238|E3|Reported Event|Prequit Nicotine Gum Only|"Prequit Nicotine Gum Only.~Participants randomized to this condition received a 6-week supply of 2 mg gum at the initial visit. Participants will be instructed to use 10 pieces of gum daily for 6 weeks."
349211|NCT01122238|E2|Reported Event|Prequit Nicotine Patch Only|"Prequit Nicotine Patch Only~Participants randomized to this condition received a 6-week supply of 14 mg patches at the initial visit. Participant will be instructed to use one patch daily for 6 weeks."
349212|NCT01122238|E1|Reported Event|Prequit Combined Nicotine Patch + Gum|"Prequit Combined Nicotine Patch + Gum~Participants randomized to this condition received a 6-week supply of 14 mg patches and a 6-week supply of 2 mg gum at the initial visit. Participant will be instructed to use one patch daily and to use 10 pieces of gum daily for 6 weeks."
349213|NCT01122160|B1|Baseline|All Study Participants|All participants received both interventions.
349214|NCT01122160|P2|Participant Flow|Omeprazole First, Then Placebo|Prilosec (omeprazole) 20.6 mg tablet with berries (blackberries + strawberries), followed by placebo with berries (blackberries + strawberries)
349215|NCT01122160|P1|Participant Flow|Placebo First, Then Omeprazole|Placebo with berries (blackberries + strawberries), followed by Omeprazole with berries (blackberries + strawberries)
349220|NCT01122108|B1|Baseline|Colesevelam HCl (3.75g) vs Cholestyramine (12g)|Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
349221|NCT01122108|P2|Participant Flow|Cholestyramine 12g First, Then Colesevelam HCl 3.75|Cholestyramine 12g once orally in the first intervention and Colesevelam 3.75g once orally in the second intervention. Both interventions were given on the same day, 30 minutes apart.
349222|NCT01122108|P1|Participant Flow|Colesevelam HCl 3.75g First, Then Cholestyramine 12g|Colesevelam HCl 3.75g once orally in the first intervention and Cholestyramine 12g once orally in the second intervention. Both interventions were given on the same day, 30 minutes apart.
349223|NCT01122108|O2|Outcome|Cholestyramine (12g)|
349224|NCT01122108|O1|Outcome|Colesevelam HCl (3.75g)|Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
349225|NCT01122108|O2|Outcome|Cholestyramine (12g)|Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
349226|NCT01122108|O1|Outcome|Colesevelam HCl (3.75g)|Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
349227|NCT01122108|E3|Reported Event|More Than 30 Minutes After Last Beverage|This group summarizes the adverse events that occurred more than 30 mintures after the last beverage administered, and thus cannot be attributed to one specific bile acid sequestrant.
349228|NCT01122108|E2|Reported Event|Colesevelam HCl (3.75 Grams)|
349229|NCT01122108|E1|Reported Event|Cholestyramine (12g)|Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
349230|NCT01122030|B8|Baseline|Total|Total of all reporting groups
349231|NCT01122030|B7|Baseline|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349232|NCT01122030|B6|Baseline|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349233|NCT01122030|B5|Baseline|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349234|NCT01122030|B4|Baseline|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349235|NCT01122030|B3|Baseline|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349236|NCT01122030|B2|Baseline|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349237|NCT01122030|B1|Baseline|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
349238|NCT01122030|P7|Participant Flow|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349239|NCT01122030|P6|Participant Flow|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349240|NCT01122030|P5|Participant Flow|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349241|NCT01122030|P4|Participant Flow|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349242|NCT01122030|P3|Participant Flow|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349243|NCT01122030|P2|Participant Flow|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349244|NCT01122030|P1|Participant Flow|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
349245|NCT01122030|O6|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349246|NCT01122030|O5|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349247|NCT01122030|O4|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349248|NCT01122030|O3|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349249|NCT01122030|O2|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349250|NCT01122030|O1|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349251|NCT01122030|O6|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349252|NCT01122030|O5|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349253|NCT01122030|O4|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349254|NCT01122030|O3|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349255|NCT01122030|O2|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349256|NCT01122030|O1|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349257|NCT01122030|O6|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349260|NCT01122030|O3|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349261|NCT01122030|O2|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349262|NCT01122030|O1|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349263|NCT01122030|O6|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349264|NCT01122030|O5|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349265|NCT01122030|O4|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349266|NCT01122030|O3|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349267|NCT01122030|O2|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349268|NCT01122030|O1|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349269|NCT01122030|O6|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349270|NCT01122030|O5|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349271|NCT01122030|O4|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349272|NCT01122030|O3|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349273|NCT01122030|O2|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349274|NCT01122030|O1|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349275|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349276|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349277|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349278|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349279|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349280|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349281|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
349282|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349283|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349284|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349285|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349286|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349287|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349288|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
349289|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349290|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349291|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349292|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349293|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349294|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349295|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
349296|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349297|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349298|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349299|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349300|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349301|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349302|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
349303|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349304|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349305|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349306|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349307|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349308|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349309|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
349310|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349311|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349312|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349313|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349314|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349315|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349316|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
349317|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349318|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349319|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349320|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349321|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349322|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349323|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
349324|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349325|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349326|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349327|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349328|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349329|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349330|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
349331|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349332|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349333|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349334|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349335|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349336|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349337|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
349338|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349339|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349340|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349341|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349342|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349343|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349344|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
349345|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349346|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349347|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349348|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349349|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349350|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349351|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
349352|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349353|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349354|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349355|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349356|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349357|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349358|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
349359|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349360|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349361|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349362|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349363|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349364|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349365|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
349366|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349367|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349368|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349369|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349370|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349371|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349372|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
349373|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349374|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349375|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349376|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349377|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349378|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349379|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
349380|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349381|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349382|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349383|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349384|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349385|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349386|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
349387|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349388|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349389|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349390|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349391|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349392|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349393|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
349394|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349395|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349396|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349397|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349398|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349399|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349400|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
349401|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349402|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349403|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349404|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349405|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349406|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349407|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
349408|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349409|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349410|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349411|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349412|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349413|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349414|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
349415|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349416|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
349417|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349418|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349419|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349420|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349421|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
349422|NCT01122030|E7|Reported Event|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349423|NCT01122030|E6|Reported Event|Naldemedine 1 mg|Participants received a single dose of 1mg naldemedine tablets administered on Day 15 under fasted conditions.
349424|NCT01122030|E5|Reported Event|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
349425|NCT01122030|E4|Reported Event|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
349426|NCT01122030|E3|Reported Event|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349427|NCT01122030|E2|Reported Event|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
349428|NCT01122030|E1|Reported Event|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
349429|NCT01121991|B1|Baseline|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
349571|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349430|NCT01121991|P1|Participant Flow|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
349431|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
349432|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
349433|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
349434|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
349435|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
349436|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
349437|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
349438|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
349439|NCT01121991|E1|Reported Event|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
349440|NCT01121939|B1|Baseline|All Patients|"Bevacizumab: 15 mg/kg IV Day 1. The first dose should be administered over~90 minutes. If no adverse reactions occur after the initial dose, the second dose should~be administered over a minimum of 60 minutes. If no adverse reactions occur after the~second dose, all subsequent doses should be administered over a minimum of 30~minutes. Bevacizumab will be infused prior to pertuzumab.~Pertuzumab: 840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes.~Sandostatin LAR® Depot: 30 mg will be given every 28 days by IM injection."
349441|NCT01121939|P1|Participant Flow|All Patients|"Bevacizumab: 15 mg/kg IV Day 1. The first dose should be administered over~90 minutes. If no adverse reactions occur after the initial dose, the second dose should~be administered over a minimum of 60 minutes. If no adverse reactions occur after the~second dose, all subsequent doses should be administered over a minimum of 30~minutes. Bevacizumab will be infused prior to pertuzumab.~Pertuzumab: 840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes.~Sandostatin LAR® Depot: 30 mg will be given every 28 days by IM injection."
349442|NCT01121939|O3|Outcome|All Patients|All patients on study (treatment is same for all patients)
349443|NCT01121939|O2|Outcome|Pancreatic Islet Cell|Patients with pancreatic islet cell disease
349444|NCT01121939|O1|Outcome|Typical Carcinoid|Patients with typical carcinoid disease
349445|NCT01121939|O2|Outcome|Pancreatic Islet Cell|Patients with pancreatic islet cell disease
349446|NCT01121939|O1|Outcome|Typical Carcinoid|Patients with typical carcinoid disease
349447|NCT01121939|O2|Outcome|Pancreatic Islet Cell|Patients with pancreatic islet cell disease
349448|NCT01121939|O1|Outcome|Typical Carcinoid|Patients with typical carcinoid disease
349449|NCT01121939|O1|Outcome|All Patients|"Bevacizumab: 15 mg/kg IV Day 1. The first dose should be administered over~90 minutes. If no adverse reactions occur after the initial dose, the second dose should~be administered over a minimum of 60 minutes. If no adverse reactions occur after the~second dose, all subsequent doses should be administered over a minimum of 30~minutes. Bevacizumab will be infused prior to pertuzumab.~Pertuzumab: 840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes.~Sandostatin LAR® Depot: 30 mg will be given every 28 days by IM injection."
349450|NCT01121939|O3|Outcome|All Patients|All patients on study (treatment is same for all patients)
349451|NCT01121939|O2|Outcome|Pancreatic Islet Cell|Patients with pancreatic islet cell disease
349452|NCT01121939|O1|Outcome|Typical Carcinoid|Patients with typical carcinoid disease
349473|NCT01121913|B1|Baseline|Entire Study Population|Includes groups randomized to receive Trazodone Contramid® OAD (prototype 1) First, Trazodone Contramid® OAD (prototype 2) First, Triticco® First, and Desyrel® First.
349572|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
350644|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
349453|NCT01121939|E1|Reported Event|All Patients|"Bevacizumab: 15 mg/kg IV Day 1. The first dose should be administered over~90 minutes. If no adverse reactions occur after the initial dose, the second dose should~be administered over a minimum of 60 minutes. If no adverse reactions occur after the~second dose, all subsequent doses should be administered over a minimum of 30~minutes. Bevacizumab will be infused prior to pertuzumab.~Pertuzumab: 840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes.~Sandostatin LAR® Depot: 30 mg will be given every 28 days by IM injection."
349454|NCT01121926|B1|Baseline|Entire Study Population|"Includes groups randomized to receive Trazodone Contramid® OAD (Once-A-Day) test product first and Trazodone IR (Apotex Corp.) reference product first.~IR = Immediate Release"
349455|NCT01121926|P2|Participant Flow|Reference (Trazodone IR [Apotex Corp.]) First|"Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in first treatment phase followed by Trazodone Contramid® OAD (Once-A-Day) test product (300 mg tablet administered once daily) dosed in the second treatment phase. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.~IR = Immediate Release."
349456|NCT01121926|P1|Participant Flow|Test (Trazodone Contramid® OAD) First|"Trazodone Contramid® OAD (Once-A-Day) test product (300 mg tablet administered once daily) dosed in first treatment phase followed by Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in the second treatment phase. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.~IR = Immediate Release."
349457|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349458|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349459|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349460|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349461|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349462|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349463|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349464|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349465|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349466|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349467|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349468|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349469|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349470|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349471|NCT01121926|E2|Reported Event|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349472|NCT01121926|E1|Reported Event|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349563|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349474|NCT01121913|P4|Participant Flow|Desyrel® First|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in treatment phase I; followed by 1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in treatment phase II; 2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in treatment phase III; and 1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in treatment phase IV. There was a washout period of 7 days between treatment phases.
349475|NCT01121913|P3|Participant Flow|Triticco® First|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in treatment phase I; followed by 3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in treatment phase II; 1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in treatment phase III; and 1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in treatment phase IV. There was a washout period of 7 days between treatment phases.
349476|NCT01121913|P2|Participant Flow|Trazodone Contramid® OAD (Prototype 2) First|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in treatment phase I, followed by 1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in treatment phase II; 3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in treatment phase III; and 2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in treatment phase IV. There was a washout period of 7 days between treatment phases.
349477|NCT01121913|P1|Participant Flow|Trazodone Contramid® OAD (Prototype 1) First|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in treatment phase I; followed by 2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in treatment phase II; 1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in treatment phase III; and 3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in treatment phase IV. There was a washout period of 7 days between treatment phases.
349478|NCT01121913|O4|Outcome|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
349479|NCT01121913|O3|Outcome|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
349480|NCT01121913|O2|Outcome|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
349481|NCT01121913|O1|Outcome|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
349482|NCT01121913|O4|Outcome|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
349483|NCT01121913|O3|Outcome|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
349484|NCT01121913|O2|Outcome|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
349485|NCT01121913|O1|Outcome|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
349486|NCT01121913|O4|Outcome|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
349487|NCT01121913|O3|Outcome|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
349488|NCT01121913|O2|Outcome|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
349489|NCT01121913|O1|Outcome|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
349490|NCT01121913|O4|Outcome|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
349491|NCT01121913|O3|Outcome|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
349492|NCT01121913|O2|Outcome|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
349493|NCT01121913|O1|Outcome|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
349494|NCT01121913|O4|Outcome|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
349495|NCT01121913|O3|Outcome|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
349496|NCT01121913|O2|Outcome|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
349497|NCT01121913|O1|Outcome|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
349498|NCT01121913|O4|Outcome|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
349499|NCT01121913|O3|Outcome|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
349500|NCT01121913|O2|Outcome|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
349501|NCT01121913|O1|Outcome|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
349502|NCT01121913|E4|Reported Event|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
349503|NCT01121913|E3|Reported Event|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
349504|NCT01121913|E2|Reported Event|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
349505|NCT01121913|E1|Reported Event|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
349506|NCT01121900|B1|Baseline|Entire Study Population|Includes groups randomized to receive Test first and Reference first.
349564|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349565|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349507|NCT01121900|P2|Participant Flow|Reference (Trazodone IR [Apotex Corp.]) First|"Trazodone IR (Apotex Corp.) reference product (100 mg tablet thrice daily) dosed in first treatment phase followed by Trazodone Contramid® OAD (Once-A-Day) test product (300 mg tablet once daily) dosed in the second treatment phase. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in treatment period 1 and the first administration of study medication in treatment period 2.~IR = Immediate Release."
349508|NCT01121900|P1|Participant Flow|Test (Trazodone Contramid® OAD) First|"Trazodone Contramid® OAD (Once-A-Day) test product (300 mg tablet once daily) dosed in first treatment phase followed by Trazodone IR (Apotex Corp.) reference product (100 mg tablet thrice daily) dosed in the second treatment phase. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in treatment period 1 and the first administration of study medication in treatment period 2.~IR = Immediate Release."
349509|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349510|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349511|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349512|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349513|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349514|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349515|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349516|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349517|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349518|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349519|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349520|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349521|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349522|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349523|NCT01121900|E2|Reported Event|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349524|NCT01121900|E1|Reported Event|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
349525|NCT01121757|B3|Baseline|Total|Total of all reporting groups
349566|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
352922|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
349526|NCT01121757|B2|Baseline|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
349527|NCT01121757|B1|Baseline|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
349528|NCT01121757|P2|Participant Flow|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
349529|NCT01121757|P1|Participant Flow|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
349530|NCT01121757|O2|Outcome|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
349531|NCT01121757|O1|Outcome|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
349532|NCT01121757|O2|Outcome|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
349533|NCT01121757|O1|Outcome|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
349534|NCT01121757|O2|Outcome|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
349535|NCT01121757|O1|Outcome|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
349567|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349568|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349536|NCT01121757|O2|Outcome|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
349537|NCT01121757|O1|Outcome|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
349538|NCT01121757|O2|Outcome|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
349539|NCT01121757|O1|Outcome|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
349540|NCT01121757|E2|Reported Event|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
349541|NCT01121757|E1|Reported Event|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
349542|NCT01121666|B3|Baseline|Total|Total of all reporting groups
349543|NCT01121666|B2|Baseline|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349544|NCT01121666|B1|Baseline|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349545|NCT01121666|P2|Participant Flow|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349546|NCT01121666|P1|Participant Flow|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349547|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349548|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349549|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349550|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349551|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349552|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349553|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349554|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349555|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349556|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349557|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349558|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349559|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349560|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349561|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349562|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
350645|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
349573|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349574|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349575|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349576|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349577|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349578|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349579|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349580|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349581|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349582|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349583|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349584|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349585|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349586|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349587|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349588|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349589|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349590|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349591|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349592|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349593|NCT01121666|E2|Reported Event|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349594|NCT01121666|E1|Reported Event|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
349595|NCT01121575|B7|Baseline|Total|Total of all reporting groups
349596|NCT01121575|B6|Baseline|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
349597|NCT01121575|B5|Baseline|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
349598|NCT01121575|B4|Baseline|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349599|NCT01121575|B3|Baseline|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349600|NCT01121575|B2|Baseline|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349601|NCT01121575|B1|Baseline|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349602|NCT01121575|P6|Participant Flow|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
349603|NCT01121575|P5|Participant Flow|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
349604|NCT01121575|P4|Participant Flow|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349605|NCT01121575|P3|Participant Flow|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349606|NCT01121575|P2|Participant Flow|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349607|NCT01121575|P1|Participant Flow|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg twice a day (BID) and oral dacomitinib 30 mg once daily (QD). The first cycle was for 28 days thereafter, each cycle was 21 days.
349608|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 2)|Participants who progressed on dacomitinib were changed from single agent dacomitinib at the prevailing dose to combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles) as soon as feasible, and no later than 28 days after documentation of disease progression. The participants in this group received 30 mg QD doses of dacomitinib in combination with 200 mg BID doses of crizotinib.
349609|NCT01121575|O1|Outcome|Dacomitinib Alone (Expansion Cohort 2)|Participants received dacomitinib (30 mg, QD) alone in 21-day cycles until disease progression.
349610|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 2)|Participants who progressed on dacomitinib were changed from single agent dacomitinib at the prevailing dose to combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles) as soon as feasible, and no later than 28 days after documentation of disease progression. The participants in this group received 30 mg QD doses of dacomitinib in combination with 200 mg BID doses of crizotinib.
349611|NCT01121575|O1|Outcome|Dacomitinib Alone (Expansion Cohort 2)|Participants received dacomitinib (30 mg, QD) alone in 21-day cycles until disease progression.
349612|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 2)|Participants who progressed on dacomitinib were changed from single agent dacomitinib at the prevailing dose to combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles) as soon as feasible, and no later than 28 days after documentation of disease progression. The participants in this group received 30 mg QD doses of dacomitinib in combination with 200 mg BID doses of crizotinib.
349613|NCT01121575|O1|Outcome|Dacomitinib Alone (Expansion Cohort 2)|Participants received dacomitinib (30 mg, QD) alone in 21-day cycles until disease progression.
349614|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 2)|Participants who progressed on dacomitinib were changed from single agent dacomitinib at the prevailing dose to combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles) as soon as feasible, and no later than 28 days after documentation of disease progression. The participants in this group received 30 mg QD doses of dacomitinib in combination with 200 mg BID doses of crizotinib.
349615|NCT01121575|O1|Outcome|Dacomitinib Alone (Expansion Cohort 2)|Participants received dacomitinib (30 mg, QD) alone in 21-day cycles until disease progression.
349616|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 2)|Participants who progressed on dacomitinib were changed from single agent dacomitinib at the prevailing dose to combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles) as soon as feasible, and no later than 28 days after documentation of disease progression. The participants in this group received 30 mg QD doses of dacomitinib in combination with 200 mg BID doses of crizotinib.
349617|NCT01121575|O1|Outcome|Dacomitinib Alone (Expansion Cohort 2)|Participants received dacomitinib (30 mg, QD) alone in 21-day cycles until disease progression.
349618|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 2)|Participants who progressed on dacomitinib were changed from single agent dacomitinib at the prevailing dose to combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles) as soon as feasible, and no later than 28 days after documentation of disease progression. The participants in this group received 30 mg QD doses of dacomitinib in combination with 200 mg BID doses of crizotinib.
349619|NCT01121575|O1|Outcome|Dacomitinib Alone (Expansion Cohort 2)|Participants received dacomitinib (30 mg, QD) alone in 21-day cycles until disease progression.
349620|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 1)|Participants received combined oral crizotinib (200 mg BID) and oral dacomitinib (30 mg QD) on a continuous daily schedule. Each cycle was 21 days.
349621|NCT01121575|O1|Outcome|Crizotinib Alone (Expansion Cohort 1)|Participants received crizotinib alone continuous 200 mg BID dosing for approximately 12 days (±2 days).
349622|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 1)|Participants received combined oral crizotinib (200 mg BID) and oral dacomitinib (30 mg QD) on a continuous daily schedule. Each cycle was 21 days.
349623|NCT01121575|O1|Outcome|Crizotinib Alone (Expansion Cohort 1)|Participants received crizotinib alone continuous 200 mg BID dosing for approximately 12 days (±2 days).
349624|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 1)|Participants received combined oral crizotinib (200 mg BID) and oral dacomitinib (30 mg QD) on a continuous daily schedule. Each cycle was 21 days.
349625|NCT01121575|O1|Outcome|Crizotinib Alone (Expansion Cohort 1)|Participants received crizotinib alone continuous 200 mg BID dosing for approximately 12 days (±2 days).
349626|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 1)|Participants received combined oral crizotinib (200 mg BID) and oral dacomitinib (30 mg QD) on a continuous daily schedule. Each cycle was 21 days.
349627|NCT01121575|O1|Outcome|Crizotinib Alone (Expansion Cohort 1)|Participants received crizotinib alone continuous 200 mg BID dosing for approximately 12 days (±2 days).
349628|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 1)|Participants received combined oral crizotinib (200 mg BID) and oral dacomitinib (30 mg QD) on a continuous daily schedule. Each cycle was 21 days.
349629|NCT01121575|O1|Outcome|Crizotinib Alone (Expansion Cohort 1)|Participants received crizotinib alone continuous 200 mg BID dosing for approximately 12 days (±2 days).
349630|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 1)|Participants received combined oral crizotinib (200 mg BID) and oral dacomitinib (30 mg QD) on a continuous daily schedule.
349631|NCT01121575|O1|Outcome|Crizotinib Alone (Expansion Cohort 1)|Participants received crizotinib alone continuous 200 mg BID dosing for approximately 12 days (±2 days).
349632|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349633|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349634|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349635|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349636|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349637|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349638|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349639|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349640|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349641|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349642|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349643|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349644|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349645|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349646|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349647|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349648|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349649|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349650|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349651|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349652|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349653|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349654|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349655|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349656|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349657|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349658|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349659|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349660|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349661|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349662|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349663|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349664|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349665|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349666|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349667|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349668|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349669|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349670|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349671|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349672|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
349673|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
349674|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
349675|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
349676|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
349677|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
349678|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
349679|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
349680|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
352923|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
349681|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
349682|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
349683|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
349684|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
349685|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
349686|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
349687|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
349688|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
349689|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
349690|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349691|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349692|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349693|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349694|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
349695|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
349696|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
349697|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
349698|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349699|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349700|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349701|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349702|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
349703|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
349704|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349705|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349706|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349707|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349708|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349709|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349710|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349711|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349712|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
349713|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
349714|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349715|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349716|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349927|NCT01121211|O1|Outcome|Testosterone|"Testosterone x 24 weeks~Testosterone: Testosterone 300mcg transdermal patch x 24 weeks.~Placebo: Placebo transdermal patch x 24 weeks"
349717|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349718|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
349719|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
349720|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349721|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349722|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349723|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
349724|NCT01121575|E6|Reported Event|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
349725|NCT01121575|E5|Reported Event|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
349726|NCT01121575|E4|Reported Event|PF-02341066, 250 mg QD/ PF-00299804, 45 mg QD|Participants enrolled in dose escalation received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg. The first cycle was for 28 days thereafter, each cycle was 21 days.
349727|NCT01121575|E3|Reported Event|PF-02341066, 250 mg BID/ PF-00299804, 30 mg QD|Participants enrolled in dose escalation received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg. The first cycle was for 28 days thereafter, each cycle was 21 days.
349728|NCT01121575|E2|Reported Event|PF-02341066, 200 mg BID/ PF-00299804, 45 mg QD|Participants enrolled in dose escalation received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg. The first cycle was for 28 days thereafter, each cycle was 21 days.
349729|NCT01121575|E1|Reported Event|PF-02341066, 200 mg BID/ PF-00299804, 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg. The first cycle was for 28 days thereafter, each cycle was 21 days.
349730|NCT01121562|B1|Baseline|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
349731|NCT01121562|P1|Participant Flow|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
349732|NCT01121562|O1|Outcome|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
349733|NCT01121562|O1|Outcome|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
349734|NCT01121562|O1|Outcome|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
349735|NCT01121562|O1|Outcome|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
349736|NCT01121562|O1|Outcome|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
349737|NCT01121562|O1|Outcome|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
349738|NCT01121562|E1|Reported Event|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
349739|NCT01121549|B1|Baseline|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
349740|NCT01121549|P1|Participant Flow|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
349741|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
349742|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
352924|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
349743|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
349744|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
349745|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
349746|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
349747|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
349748|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
349749|NCT01121549|E1|Reported Event|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
349750|NCT01121536|B1|Baseline|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
349751|NCT01121536|P1|Participant Flow|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
349752|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
349753|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
349754|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
349755|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
349756|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
349757|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
349758|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
349759|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
349760|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
349761|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
349859|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
349860|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
349762|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
349763|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
349764|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
349765|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
349766|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
349767|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
349768|NCT01121536|E1|Reported Event|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
349769|NCT01121484|B3|Baseline|Total|Total of all reporting groups
349770|NCT01121484|B2|Baseline|Placebo|Matching placebo tablets once daily for 10 weeks
349771|NCT01121484|B1|Baseline|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
349772|NCT01121484|P2|Participant Flow|Placebo|Matching placebo tablets once daily for 10 weeks
349773|NCT01121484|P1|Participant Flow|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
349774|NCT01121484|O2|Outcome|Placebo|Matching placebo tablets once daily for 10 weeks
349775|NCT01121484|O1|Outcome|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
349776|NCT01121484|O2|Outcome|Placebo|Matching placebo tablets once daily for 10 weeks
349777|NCT01121484|O1|Outcome|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
349778|NCT01121484|O2|Outcome|Placebo|Matching placebo tablets once daily for 10 weeks
349779|NCT01121484|O1|Outcome|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
349780|NCT01121484|O2|Outcome|Placebo|Matching placebo tablets once daily for 10 weeks
349781|NCT01121484|O1|Outcome|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
349782|NCT01121484|O2|Outcome|Placebo|Matching placebo tablets once daily for 10 weeks
349783|NCT01121484|O1|Outcome|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
349784|NCT01121484|O2|Outcome|Placebo|Matching placebo tablets once daily for 10 weeks
349785|NCT01121484|O1|Outcome|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
349786|NCT01121484|E2|Reported Event|Placebo|Matching placebo tablets once daily for 10 weeks
349787|NCT01121484|E1|Reported Event|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
349788|NCT01121406|B3|Baseline|Total|Total of all reporting groups
349789|NCT01121406|B2|Baseline|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
349790|NCT01121406|B1|Baseline|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349806|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
350646|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
349791|NCT01121406|P2|Participant Flow|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
349792|NCT01121406|P1|Participant Flow|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349793|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
349794|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349795|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349796|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349797|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349798|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349799|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349800|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349801|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349802|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349803|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349804|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349805|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
352925|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
349807|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349808|NCT01121406|O3|Outcome|Cytotoxic to Volasertib Switch|Patients of the cytotoxic arm who switched to treatment with Volasertib (BI 6727).
349809|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
349810|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349811|NCT01121406|O3|Outcome|Cytotoxic to Volasertib Switch|Patients of the cytotoxic arm who switched to treatment with Volasertib (BI 6727).
349812|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
349813|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349814|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
349815|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349816|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
349817|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349818|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
349819|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349857|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
349858|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
352926|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
349820|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
349821|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349822|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
349823|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349824|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
349825|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349826|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
349827|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349828|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
349829|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349830|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
349831|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349832|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
349833|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349834|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
349835|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349836|NCT01121406|E3|Reported Event|Cytotoxic to Volasertib Switch|Patients of the cytotoxic arm who switched to treatment with Volasertib (BI 6727).
349837|NCT01121406|E2|Reported Event|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
349838|NCT01121406|E1|Reported Event|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
349839|NCT01121393|B3|Baseline|Total|Total of all reporting groups
349840|NCT01121393|B2|Baseline|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
349841|NCT01121393|B1|Baseline|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
349842|NCT01121393|P2|Participant Flow|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics.
349843|NCT01121393|P1|Participant Flow|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 milligram (mg) once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction.
349844|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
349845|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
349846|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
349847|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
349848|NCT01121393|O3|Outcome|Afatinib 50mg q.d.|Patients receiving Afatinib 50mg once daily (q.d.) after a dose escalation.
349849|NCT01121393|O2|Outcome|Afatinib 40mg q.d.|Patients receiving Afatinib 40mg once daily (q.d.)
349850|NCT01121393|O1|Outcome|Afatinib 30mg q.d.|Patients receiving Afatinib 30mg once daily (q.d.) after a dose reduction.
349851|NCT01121393|O3|Outcome|Afatinib 50mg q.d.|Patients receiving Afatinib 50mg once daily (q.d.) after a dose escalation.
349852|NCT01121393|O2|Outcome|Afatinib 40mg q.d.|Patients receiving Afatinib 40mg once daily (q.d.)
349853|NCT01121393|O1|Outcome|Afatinib 30mg q.d.|Patients receiving Afatinib 30mg once daily (q.d.) after a dose reduction.
349854|NCT01121393|O3|Outcome|Afatinib 50mg q.d.|Patients receiving Afatinib 50mg once daily (q.d.) orally after a dose escalation.
349855|NCT01121393|O2|Outcome|Afatinib 40mg q.d.|Patients receiving Afatinib 40mg once daily (q.d.) orally
349856|NCT01121393|O1|Outcome|Afatinib 30mg q.d.|Patients receiving Afatinib 30mg once daily (q.d.) orally after a dose reduction.
349981|NCT01121146|O1|Outcome|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
349861|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
349862|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
349863|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
349864|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
349865|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
349866|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
349867|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
349868|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
349869|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
349870|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
349871|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
349872|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
349873|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
349874|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
349875|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
349876|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
349877|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
349878|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
349879|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
349880|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
349881|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
349882|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
349883|NCT01121393|E2|Reported Event|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
349884|NCT01121393|E1|Reported Event|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
349885|NCT01121263|B3|Baseline|Total|Total of all reporting groups
349886|NCT01121263|B2|Baseline|Cohort 2: Intervention Cohort - PCI Group (N=98)|Patients who met proposed anatomic and clinical eligibility criteria and underwent multivessel Percutaneous Coronary Intervention (PCI) with drug eluting stents (DES)
349887|NCT01121263|B1|Baseline|Cohort 2: Intervention Cohort - HCR Group (N=200)|Patients who underwent Hybrid Coronary Revascularization (HCR) with minimally invasive LIMA-LAD CABG
349888|NCT01121263|P2|Participant Flow|Cohort 2: Intervention Cohort - PCI Group (N=98)|Patients who met proposed anatomic and clinical eligibility criteria and underwent multivessel Percutaneous Coronary Intervention (PCI) with drug eluting stents (DES)
349889|NCT01121263|P1|Participant Flow|Cohort 2: Intervention Cohort - HCR Group (N=200)|Patients who underwent Hybrid Coronary Revascularization (HCR) with minimally invasive LIMA-LAD CABG
349890|NCT01121263|O2|Outcome|PCI Group (N=98)|Occurrence of MACCE through the end of study in Cohort 2: Intervention Cohort - PCI Group
349891|NCT01121263|O1|Outcome|HCR Group (N=200)|Occurrence of MACCE through the end of study in Cohort 2: Intervention Cohort - HCR Group
349892|NCT01121263|O2|Outcome|PCI Group (N=98)|Primary Outcome in Cohort 2: Intervention Cohort - PCI Group
349893|NCT01121263|O1|Outcome|HCR Group (N=200)|Primary Outcome in Cohort 2: Intervention Cohort - HCR Group
349894|NCT01121263|E2|Reported Event|PCI Group (N=98)|Serious Adverse Events in Cohort 2: Intervention Cohort - PCI Group
349895|NCT01121263|E1|Reported Event|HCR Group (N=200)|Serious Adverse Events in Cohort 2: Intervention Cohort - HCR Group
349896|NCT01121224|B3|Baseline|Total|Total of all reporting groups
349897|NCT01121224|B2|Baseline|DES Group|"Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s).~Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion.~Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
349926|NCT01121211|O2|Outcome|Placebo|"Placebo x 24 weeks~Testosterone: Testosterone 300mcg transdermal patch x 24 weeks.~Placebo: Placebo transdermal patch x 24 weeks"
349898|NCT01121224|B1|Baseline|BMS Group|"Patients who receive a bare metal stent in the saphenous vein graft target lesion(s).~Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion.~Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
349899|NCT01121224|P2|Participant Flow|Drug Eluting Stent Group|"Patients who receive a drug-eluting stent (DES) in the saphenous vein graft target lesion(s).~Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion.~Blinded clopidogrel: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion.~Thienopyridine (open-label): For ACS patients who receive Bare Metal Stent (BMS) or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
349900|NCT01121224|P1|Participant Flow|Bare Metal Stent Group|"Patients who receive a bare metal stent (BMS) in the saphenous vein graft target lesion(s).~Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion.~Placebo: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive only BMS.~Thienopyridine (open-label): For ACS patients who receive BMS or Drug Eluting Stent (DES) in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
349901|NCT01121224|O2|Outcome|DES Group|"Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s).~Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion.~Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
349902|NCT01121224|O1|Outcome|BMS Group|"Patients who receive a bare metal stent in the saphenous vein graft target lesion(s).~Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion.~Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
349903|NCT01121224|O2|Outcome|DES Group|"Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s).~Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion.~Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
349904|NCT01121224|O1|Outcome|BMS Group|"Patients who receive a bare metal stent in the saphenous vein graft target lesion(s).~Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion.~Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
349905|NCT01121224|O2|Outcome|DES Group|"Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s).~Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion.~Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
349906|NCT01121224|O1|Outcome|BMS Group|"Patients who receive a bare metal stent in the saphenous vein graft target lesion(s).~Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion.~Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
349907|NCT01121224|O2|Outcome|DES Group|"Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s).~Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion.~Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
349908|NCT01121224|O1|Outcome|BMS Group|"Patients who receive a bare metal stent in the saphenous vein graft target lesion(s).~Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion.~Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
349909|NCT01121224|O2|Outcome|DES Group|"Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s).~Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion.~Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
350129|NCT01120691|B4|Baseline|Total|Total of all reporting groups
349910|NCT01121224|O1|Outcome|BMS Group|"Patients who receive a bare metal stent in the saphenous vein graft target lesion(s).~Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion.~Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
349911|NCT01121224|O2|Outcome|DES Group|"Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s).~Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion.~Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
349912|NCT01121224|O1|Outcome|BMS Group|"Patients who receive a bare metal stent in the saphenous vein graft target lesion(s).~Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion.~Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
349913|NCT01121224|O2|Outcome|DES Group|"Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s).~Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion.~Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
349914|NCT01121224|O1|Outcome|BMS Group|"Patients who receive a bare metal stent in the saphenous vein graft target lesion(s).~Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion.~Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
349915|NCT01121224|O2|Outcome|DES Group|"Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s).~Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion.~Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
349916|NCT01121224|O1|Outcome|BMS Group|"Patients who receive a bare metal stent in the saphenous vein graft target lesion(s).~Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion.~Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
349917|NCT01121224|O2|Outcome|DES Group|"Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s).~Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion.~Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
349918|NCT01121224|O1|Outcome|BMS Group|"Patients who receive a bare metal stent in the saphenous vein graft target lesion(s).~Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion.~Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
349919|NCT01121224|E2|Reported Event|DES Group|"Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s).~Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion.~Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
349920|NCT01121224|E1|Reported Event|BMS Group|"Patients who receive a bare metal stent in the saphenous vein graft target lesion(s).~Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion.~Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS.~Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion."
349921|NCT01121211|B3|Baseline|Total|Total of all reporting groups
349922|NCT01121211|B2|Baseline|Placebo|"Placebo x 24 weeks~Testosterone: Testosterone 300mcg transdermal patch x 24 weeks.~Placebo: Placebo transdermal patch x 24 weeks"
349923|NCT01121211|B1|Baseline|Testosterone|"Testosterone x 24 weeks~Testosterone: Testosterone 300mcg transdermal patch x 24 weeks.~Placebo: Placebo transdermal patch x 24 weeks"
349924|NCT01121211|P2|Participant Flow|Placebo|"Placebo x 24 weeks~Placebo: Placebo transdermal patch x 24 weeks"
349925|NCT01121211|P1|Participant Flow|Testosterone|"Testosterone x 24 weeks~Testosterone: Testosterone 300mcg transdermal patch x 24 weeks."
350647|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
349928|NCT01121211|O2|Outcome|Placebo|"Placebo x 24 weeks~Testosterone: Testosterone 300mcg transdermal patch x 24 weeks.~Placebo: Placebo transdermal patch x 24 weeks"
349929|NCT01121211|O1|Outcome|Testosterone|"Testosterone x 24 weeks~Testosterone: Testosterone 300mcg transdermal patch x 24 weeks.~Placebo: Placebo transdermal patch x 24 weeks"
349930|NCT01121211|E2|Reported Event|Placebo|"Placebo x 24 weeks~Placebo: Placebo transdermal patch x 24 weeks"
349931|NCT01121211|E1|Reported Event|Testosterone|"Testosterone x 24 weeks~Testosterone: Testosterone 300mcg transdermal patch x 24 weeks."
349932|NCT01121185|B3|Baseline|Total|Total of all reporting groups
349933|NCT01121185|B2|Baseline|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
349934|NCT01121185|B1|Baseline|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
349935|NCT01121185|P2|Participant Flow|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
349936|NCT01121185|P1|Participant Flow|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
349937|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
349938|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
349939|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
349940|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
349941|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
349942|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
349943|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
349944|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
349945|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
349946|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
349947|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
349948|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
349949|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
349950|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
349951|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
349952|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
349953|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
349954|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
349955|NCT01121185|E2|Reported Event|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
349956|NCT01121185|E1|Reported Event|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
349957|NCT01121172|B3|Baseline|Total|Total of all reporting groups
349958|NCT01121172|B2|Baseline|Lean|lean children and adolescents matched for age and gender to the obese group
349959|NCT01121172|B1|Baseline|Obese|obese children and adolescents according to International Obesity Task Force criteria
349960|NCT01121172|P2|Participant Flow|Lean|lean children and adolescents matched for age and gender to the obese group
349961|NCT01121172|P1|Participant Flow|Obese|obese children and adolescents according to International Obesity Task Force criteria
349962|NCT01121172|O1|Outcome|Obese Group|Obese children and adolescents according to IOTF criteria
349963|NCT01121172|O2|Outcome|Lean|lean children and adolescents matched for age and gender to the obese group
349964|NCT01121172|O1|Outcome|Obese|obese children and adolescents according to International Obesity Task Force criteria
349965|NCT01121172|E2|Reported Event|Lean|lean children and adolescents matched for age and gender to the obese group
349966|NCT01121172|E1|Reported Event|Obese|obese children and adolescents according to International Obesity Task Force criteria
349967|NCT01121146|B3|Baseline|Total|Total of all reporting groups
349968|NCT01121146|B2|Baseline|Standard Enduron Polyethylene|Total Hip Replacement : Comparison of Marathon and Enduron polyethylene
349969|NCT01121146|B1|Baseline|Crosslinked Marathon Polyethylene|Total Hip Replacement : Comparison of Marathon and Enduron polyethylene
349970|NCT01121146|P2|Participant Flow|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
349971|NCT01121146|P1|Participant Flow|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
349972|NCT01121146|O2|Outcome|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
349973|NCT01121146|O1|Outcome|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and crosslinked polyethylene liner.
349974|NCT01121146|O2|Outcome|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
349975|NCT01121146|O1|Outcome|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
349976|NCT01121146|O2|Outcome|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
349977|NCT01121146|O1|Outcome|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
349978|NCT01121146|O2|Outcome|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
349979|NCT01121146|O1|Outcome|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
349980|NCT01121146|O2|Outcome|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
350648|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
349982|NCT01121146|E2|Reported Event|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
349983|NCT01121146|E1|Reported Event|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
349984|NCT01120990|B1|Baseline|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device
349985|NCT01120990|P1|Participant Flow|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device
349986|NCT01120990|O1|Outcome|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device.
349987|NCT01120990|O1|Outcome|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device.
349988|NCT01120990|O1|Outcome|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device.
349989|NCT01120990|O1|Outcome|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device.
349990|NCT01120990|E1|Reported Event|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device
349991|NCT01120899|B1|Baseline|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
349992|NCT01120899|P1|Participant Flow|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
349993|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
349994|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
349995|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
349996|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
349997|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
349998|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
349999|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
350000|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
350001|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
350002|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
350003|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
350004|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
350005|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
350006|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
350007|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
350008|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
350009|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
350010|NCT01120899|E1|Reported Event|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
350011|NCT01120834|B1|Baseline|All Subjects|"azacytidine: • Dose level 1: azacitidine 55 mg/m2 on days 1-5~Dose level 2: azacitidine 75 mg/m2 on days 1-5~Dose level 3: azacitidine 55 mg/m2 on days 1-5~Dose level 4: azacitidine 75 mg/m2 on days 1-5~Each cycle = 28 days. Subjects may receive up to 6 cycles.~vorinostat: • Dose level 1: oral vorinostat at 300 mg BID on Days 1-7.~Dose level 2: oral vorinostat at 200 mg BID on Days 1-7.~Dose level 3: oral vorinostat at 300 mg BID on Days 1-14.~Dose level 4: oral vorinostat at 200 mg BID on Days 1-14.~Each cycle = 28 days. Subjects receive up to 6 cycles."
350012|NCT01120834|P1|Participant Flow|All Subjects|"azacytidine: • Dose level 1: azacitidine 55 mg/m2 on days 1-5~Dose level 2: azacitidine 75 mg/m2 on days 1-5~Dose level 3: azacitidine 55 mg/m2 on days 1-5~Dose level 4: azacitidine 75 mg/m2 on days 1-5~Each cycle = 28 days. Subjects may receive up to 6 cycles.~vorinostat: • Dose level 1: oral vorinostat at 300 mg BID on Days 1-7.~Dose level 2: oral vorinostat at 200 mg BID on Days 1-7.~Dose level 3: oral vorinostat at 300 mg BID on Days 1-14.~Dose level 4: oral vorinostat at 200 mg BID on Days 1-14.~Each cycle = 28 days. Subjects receive up to 6 cycles."
350013|NCT01120834|O1|Outcome|All Subjects|
350014|NCT01120834|E1|Reported Event|All Subjects|all subjects
350015|NCT01120808|B1|Baseline|All Participants|Participants were registered competitors in RacingThePlanet 6 stage 7 day 155mile (250km) ultramarathon.
350016|NCT01120808|P1|Participant Flow|All Participants|Participants were registered competitors in RacingThePlanet 6 stage 7 day 155mile (250km) ultramarathon.
350017|NCT01120808|O1|Outcome|All Participants|Participants were registered competitors in RacingThePlanet 6 stage 7 day 155mile (250km) ultramarathon.
350018|NCT01120808|E1|Reported Event|All Participants|Participants were registered competitors in RacingThePlanet 6 stage 7 day 155mile (250km) ultramarathon.
350019|NCT01120782|B1|Baseline|All Subjects|All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
350020|NCT01120782|P1|Participant Flow|All Subjects|All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
350021|NCT01120782|O1|Outcome|All Subjects|All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
350022|NCT01120782|E1|Reported Event|All Subjects|All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
350023|NCT01120717|B3|Baseline|Total|Total of all reporting groups
350024|NCT01120717|B2|Baseline|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
350025|NCT01120717|B1|Baseline|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
350026|NCT01120717|P2|Participant Flow|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
350027|NCT01120717|P1|Participant Flow|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
350028|NCT01120717|O2|Outcome|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
350029|NCT01120717|O1|Outcome|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
350030|NCT01120717|O2|Outcome|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
350031|NCT01120717|O1|Outcome|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
350032|NCT01120717|O2|Outcome|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
350033|NCT01120717|O1|Outcome|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
350034|NCT01120717|O2|Outcome|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
350035|NCT01120717|O1|Outcome|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
350036|NCT01120717|O2|Outcome|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
350037|NCT01120717|O1|Outcome|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
350038|NCT01120717|O2|Outcome|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
350039|NCT01120717|O1|Outcome|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
350040|NCT01120717|E2|Reported Event|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
350041|NCT01120717|E1|Reported Event|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
350042|NCT01120704|B33|Baseline|Total|Total of all reporting groups
350043|NCT01120704|B32|Baseline|32, 8Wks, No Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350044|NCT01120704|B31|Baseline|31, 8Wks, No Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350045|NCT01120704|B30|Baseline|30, 8Wks, No Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350046|NCT01120704|B29|Baseline|29, 8Wks, No Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350047|NCT01120704|B28|Baseline|28, 8Wks, No Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350048|NCT01120704|B27|Baseline|27, 8Wks, No Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350049|NCT01120704|B26|Baseline|26, 8Wks, No Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350050|NCT01120704|B25|Baseline|25, 8Wks, No Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350051|NCT01120704|B24|Baseline|24, 8Wks, Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350185|NCT01120626|E2|Reported Event|Sugar Pill|"sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)~sugar pill: sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)"
352927|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
350052|NCT01120704|B23|Baseline|23, 8Wks, Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350053|NCT01120704|B22|Baseline|22, 8Wks, Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350054|NCT01120704|B21|Baseline|21, 8Wks, Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350055|NCT01120704|B20|Baseline|20, 8Wks, Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350056|NCT01120704|B19|Baseline|19, 8Wks, Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350057|NCT01120704|B18|Baseline|18, 8Wks, Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350058|NCT01120704|B17|Baseline|17, 8Wks, Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350059|NCT01120704|B16|Baseline|16, 26Wks, No Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350060|NCT01120704|B15|Baseline|15, 26Wks, No Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350061|NCT01120704|B14|Baseline|14, 26Wks, No Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350062|NCT01120704|B13|Baseline|13, 26Wks, No Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350063|NCT01120704|B12|Baseline|12, 26Wks, No Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350064|NCT01120704|B11|Baseline|11, 26Wks, No Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350065|NCT01120704|B10|Baseline|10, 26Wks, No Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350066|NCT01120704|B9|Baseline|9, 26Wks, No Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350067|NCT01120704|B8|Baseline|8, 26Wks, Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350068|NCT01120704|B7|Baseline|7, 26Wks, Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350069|NCT01120704|B6|Baseline|6, 26Wks, Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350070|NCT01120704|B5|Baseline|5, 26Wks, Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350071|NCT01120704|B4|Baseline|4, 26Wks, Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350072|NCT01120704|B3|Baseline|3, 26Wks, Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350073|NCT01120704|B2|Baseline|2, 26Wks, Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350074|NCT01120704|B1|Baseline|1, 26Wks, Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350075|NCT01120704|P32|Participant Flow|32, 8Wks, No Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350076|NCT01120704|P31|Participant Flow|31, 8Wks, No Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350077|NCT01120704|P30|Participant Flow|30, 8Wks, No Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350078|NCT01120704|P29|Participant Flow|29, 8Wks, No Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350079|NCT01120704|P28|Participant Flow|28, 8Wks, No Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350080|NCT01120704|P27|Participant Flow|27, 8Wks, No Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350081|NCT01120704|P26|Participant Flow|26, 8Wks, No Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350082|NCT01120704|P25|Participant Flow|25, 8Wks, No Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350083|NCT01120704|P24|Participant Flow|24, 8Wks, Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350084|NCT01120704|P23|Participant Flow|23, 8Wks, Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350085|NCT01120704|P22|Participant Flow|22, 8Wks, Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350086|NCT01120704|P21|Participant Flow|21, 8Wks, Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350087|NCT01120704|P20|Participant Flow|20, 8Wks, Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350088|NCT01120704|P19|Participant Flow|19, 8Wks, Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350134|NCT01120691|P2|Participant Flow|NVA237|NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period. Salbutamol/albuterol was available for rescue medication use throughout the study.
350089|NCT01120704|P18|Participant Flow|18, 8Wks, Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350090|NCT01120704|P17|Participant Flow|17, 8Wks, Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350091|NCT01120704|P16|Participant Flow|16, 26Wks, No Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350092|NCT01120704|P15|Participant Flow|15, 26Wks, No Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350093|NCT01120704|P14|Participant Flow|14, 26Wks, No Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350094|NCT01120704|P13|Participant Flow|13, 26Wks, No Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350095|NCT01120704|P12|Participant Flow|12, 26Wks, No Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350096|NCT01120704|P11|Participant Flow|11, 26Wks, No Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350097|NCT01120704|P10|Participant Flow|10, 26Wks, No Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350098|NCT01120704|P9|Participant Flow|9, 26Wks, No Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350099|NCT01120704|P8|Participant Flow|8, 26Wks, Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350100|NCT01120704|P7|Participant Flow|7, 26Wks, Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350101|NCT01120704|P6|Participant Flow|6, 26Wks, Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350102|NCT01120704|P5|Participant Flow|5, 26Wks, Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350103|NCT01120704|P4|Participant Flow|4, 26Wks, Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350104|NCT01120704|P3|Participant Flow|3, 26Wks, Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350105|NCT01120704|P2|Participant Flow|2, 26Wks, Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
350106|NCT01120704|P1|Participant Flow|1, 26Wks, Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
350182|NCT01120626|O1|Outcome|Donepezil|"donepezil (2.5 mg to 10.0 mg per day for 12 weeks)~donepezil: donepezil (2.5 mg to 10.0 mg per day for 12 weeks)"
350304|NCT01120236|O1|Outcome|CTC=0|No CTCs foundin 7.5 mL blood sample collected at baseline, pooled treatment arms
350107|NCT01120704|O10|Outcome|Automated Adherence Prompting Phone Calls|Participants randomized to this condition received Automated Adherence Prompting Phone Calls; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback. The Automated Adherence Prompting Phone Calls group consists of 272 participants (approximately half the total sample of 544) who will be compared with a group that received No Automated Adherence Prompting Phone Calls (N=272; approximately half the total sample) in a main effect statistical comparison (No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls).
350108|NCT01120704|O9|Outcome|No Automated Adherence Prompting Phone Calls|Participants randomized to this condition received No Automated Adherence Prompting Phone Calls; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback. The No Automated Adherence Prompting Phone Calls group consists of 272 participants (approximately half the total sample of 544) who will be compared with a group that received Automated Adherence Prompting Phone Calls (N=272; approximately half the total sample) in a main effect statistical comparison (No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls).
350109|NCT01120704|O8|Outcome|Electronic Medication Monitoring Device Plus Feedback|Participants randomized to this condition received an Electronic Medication Monitoring Device Plus Feedback; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Electronic Medication Monitoring Device Plus Feedback group consists of 270 participants (approximately half the total sample of 544) who will be compared with a group that received an Electronic Medication Monitoring Device Without Feedback (N=274; approximately half the total sample) in a main effect statistical comparison (Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback).
350110|NCT01120704|O7|Outcome|Electronic Medication Monitoring Device Without Feedback|Participants randomized to this condition received an Electronic Medication Monitoring Device Without Feedback; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Electronic Medication Monitoring Device Without Feedback group consists of 274 participants (approximately half the total sample of 544) who will be compared with a group that received an Electronic Medication Monitoring Device Plus Feedback (N=270; approximately half the total sample) in a main effect statistical comparison (Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback).
350111|NCT01120704|O6|Outcome|Cognitive Medication Adherence Counseling|Participants randomized to this condition received Cognitive Medication Adherence Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Cognitive Medication Adherence Counseling group consists of 271 participants (approximately half the total sample of 544) who will be compared with a group that received No Cognitive Medication Adherence Counseling (N=273; approximately half the total sample) in a main effect statistical comparison (No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling).
350112|NCT01120704|O5|Outcome|No Cognitive Medication Adherence Counseling|Participants randomized to this condition received No Cognitive Medication Adherence Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The No Cognitive Medication Adherence Counseling group consists of 273 participants (approximately half the total sample of 544) who will be compared with a group that received Cognitive Medication Adherence Counseling (N=271; approximately half the total sample) in a main effect statistical comparison (No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling).
350113|NCT01120704|O4|Outcome|Maintenance Counseling|Participants randomized to this condition received Maintenance Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Maintenance Counseling group consists of 263 participants (approximately half the total sample of 544) who will be compared with a group that received Maintenance Counseling (N=281; approximately half the total sample) in a main effect statistical comparison (No Maintenance Counseling vs. Maintenance Counseling).
350130|NCT01120691|B3|Baseline|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350131|NCT01120691|B2|Baseline|NVA237|NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period. Salbutamol/albuterol was available for rescue medication use throughout the study.
350183|NCT01120626|O2|Outcome|Sugar Pill|"sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)~sugar pill: sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)"
350114|NCT01120704|O3|Outcome|No Maintenance Counseling|Participants randomized to this condition received No Maintenance Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The No Maintenance Counseling group consists of 281 participants (approximately half the total sample of 544) who will be compared with a group that received Maintenance Counseling (N=263; approximately half the total sample) in a main effect statistical comparison (No Maintenance Counseling vs. Maintenance Counseling).
350115|NCT01120704|O2|Outcome|26 Weeks of Nicotine Patch and Nicotine Gum|Participants randomized to this condition received 26 Weeks of Nicotine Patch and Nicotine Gum; participants in this group received all combinations of the other four study treatments: No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The 26 Weeks of Nicotine Patch and Nicotine Gum group consists of 275 participants (approximately half the total sample of 544) who will be compared with a group that received 8 Weeks of Nicotine Patch and Nicotine Gum (N=269; approximately half the total sample) in a main effect statistical comparison (8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum).
350116|NCT01120704|O1|Outcome|8 Weeks of Nicotine Patch and Nicotine Gum|Participants randomized to this condition received 8 Weeks of Nicotine Patch and Nicotine Gum; participants in this group received all combinations of the other four study treatments: No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The 8 Weeks of Nicotine Patch and Nicotine Gum group consists of 269 participants (approximately half the total sample of 544) who will be compared with a group that received 26 Weeks of Nicotine Patch and Nicotine Gum (N=275; approximately half the total sample) in a main effect statistical comparison (8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum).
350117|NCT01120704|O10|Outcome|Automated Adherence Prompting Phone Calls|Participants randomized to this condition received Automated Adherence Prompting Phone Calls; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback. The Automated Adherence Prompting Phone Calls group consists of 272 participants (approximately half the total sample of 544) who will be compared with a group that received No Automated Adherence Prompting Phone Calls (N=272; approximately half the total sample) in a main effect statistical comparison (No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls).
350118|NCT01120704|O9|Outcome|No Automated Adherence Prompting Phone Calls|Participants randomized to this condition received No Automated Adherence Prompting Phone Calls; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback. The No Automated Adherence Prompting Phone Calls group consists of 272 participants (approximately half the total sample of 544) who will be compared with a group that received Automated Adherence Prompting Phone Calls (N=272; approximately half the total sample) in a main effect statistical comparison (No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls).
350119|NCT01120704|O8|Outcome|Electronic Medication Monitoring Device Plus Feedback|Participants randomized to this condition received an Electronic Medication Monitoring Device Plus Feedback; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Electronic Medication Monitoring Device Plus Feedback group consists of 270 participants (approximately half the total sample of 544) who will be compared with a group that received an Electronic Medication Monitoring Device Without Feedback (N=274; approximately half the total sample) in a main effect statistical comparison (Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback).
350120|NCT01120704|O7|Outcome|Electronic Medication Monitoring Device Without Feedback|Participants randomized to this condition received an Electronic Medication Monitoring Device Without Feedback; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Electronic Medication Monitoring Device Without Feedback group consists of 274 participants (approximately half the total sample of 544) who will be compared with a group that received an Electronic Medication Monitoring Device Plus Feedback (N=270; approximately half the total sample) in a main effect statistical comparison (Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback).
350132|NCT01120691|B1|Baseline|QVA149|QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period. Salbutamol/albuterol was available for rescue medication use throughout the study.
350133|NCT01120691|P3|Participant Flow|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350184|NCT01120626|O1|Outcome|Donepezil|"donepezil (2.5 mg to 10.0 mg per day for 12 weeks)~donepezil: donepezil (2.5 mg to 10.0 mg per day for 12 weeks)"
350121|NCT01120704|O6|Outcome|Cognitive Medication Adherence Counseling|Participants randomized to this condition received Cognitive Medication Adherence Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Cognitive Medication Adherence Counseling group consists of 271 participants (approximately half the total sample of 544) who will be compared with a group that received No Cognitive Medication Adherence Counseling (N=273; approximately half the total sample) in a main effect statistical comparison (No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling).
350122|NCT01120704|O5|Outcome|No Cognitive Medication Adherence Counseling|Participants randomized to this condition received No Cognitive Medication Adherence Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The No Cognitive Medication Adherence Counseling group consists of 273 participants (approximately half the total sample of 544) who will be compared with a group that received Cognitive Medication Adherence Counseling (N=271; approximately half the total sample) in a main effect statistical comparison (No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling).
350123|NCT01120704|O4|Outcome|Maintenance Counseling|Participants randomized to this condition received Maintenance Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Maintenance Counseling group consists of 263 participants (approximately half the total sample of 544) who will be compared with a group that received Maintenance Counseling (N=281; approximately half the total sample) in a main effect statistical comparison (No Maintenance Counseling vs. Maintenance Counseling).
350124|NCT01120704|O3|Outcome|No Maintenance Counseling|Participants randomized to this condition received No Maintenance Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The No Maintenance Counseling group consists of 281 participants (approximately half the total sample of 544) who will be compared with a group that received Maintenance Counseling (N=263; approximately half the total sample) in a main effect statistical comparison (No Maintenance Counseling vs. Maintenance Counseling).
350125|NCT01120704|O2|Outcome|26 Weeks of Nicotine Patch and Nicotine Gum|Participants randomized to this condition received 26 Weeks of Nicotine Patch and Nicotine Gum; participants in this group received all combinations of the other four study treatments: No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The 26 Weeks of Nicotine Patch and Nicotine Gum group consists of 275 participants (approximately half the total sample of 544) who will be compared with a group that received 8 Weeks of Nicotine Patch and Nicotine Gum (N=269; approximately half the total sample) in a main effect statistical comparison (8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum).
350126|NCT01120704|O1|Outcome|8 Weeks of Nicotine Patch and Nicotine Gum|Participants randomized to this condition received 8 Weeks of Nicotine Patch and Nicotine Gum; participants in this group received all combinations of the other four study treatments: No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The 8 Weeks of Nicotine Patch and Nicotine Gum group consists of 269 participants (approximately half the total sample of 544) who will be compared with a group that received 26 Weeks of Nicotine Patch and Nicotine Gum (N=275; approximately half the total sample) in a main effect statistical comparison (8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum).
350127|NCT01120704|E2|Reported Event|8 Weeks of Nicotine Patch and Nicotine Gum|"Participants randomized to this condition received 8 Weeks of Nicotine Patch and Nicotine Gum.~IF participant smoked >10 cigs/day AND is randomized to a 8 week condition: they were asked to take one 21 mg patch/day for 4 weeks, THEN one 14 mg patch/day for 2 weeks, THEN one patch 7mg/day for 2 weeks.Participants were also asked to use 4-mg gum every 1-2 hours (9 pieces maximum per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment.~IF participant smoked 5-10 cigs/day AND is randomized to the 8 week medication condition: they were asked to take one 14 mg patch/day for 4 weeks, THEN one 7 mg patch/day for 4 weeks. Participants were also asked to use 2-mg gum every 1-2 hours (9 pieces max per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment."
350128|NCT01120704|E1|Reported Event|26 Weeks of Nicotine Patch and Nicotine Gum|"Participants randomized to this condition received 26 Weeks of Nicotine Patch and Nicotine Gum.~IF the participant smoked >10 cigs/day AND is randomized to a 26 week medication condition: they were asked to take one 21 mg patch per day for 22 weeks, THEN one 14 mg patch per day for 2 weeks, THEN one patch 7 mg patch per day for 2 weeks. Participants were also asked to use one piece of one 4-mg- gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication termination until they are down to one gum piece every 4-8 hours by the last week of treatment.~IF the participant smoked 5-10 cigs/day AND is randomized to a 26 week medication condition: they were asked to take one 14 mg patch per day for 22 weeks, THEN one patch 7 mg patch per day for 4 weeks. Participants were also asked to use one piece of 2-mg gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication"
350135|NCT01120691|P1|Participant Flow|QVA149|QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period. Salbutamol/albuterol was available for rescue medication use throughout the study.
350136|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350137|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350138|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350139|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350140|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350141|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350142|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350143|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350144|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350145|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350146|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350147|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350148|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350149|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350150|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350151|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks.Salbutamol/albuterol was available for rescue medication use throughout the study.
350152|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350153|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350154|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350155|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350156|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350649|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350157|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350158|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350159|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350160|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350161|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350162|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350163|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350164|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350165|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350166|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350167|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350168|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350169|NCT01120691|O2|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350170|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350171|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350172|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350173|NCT01120691|E3|Reported Event|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device. for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350174|NCT01120691|E2|Reported Event|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350175|NCT01120691|E1|Reported Event|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
350176|NCT01120626|B3|Baseline|Total|Total of all reporting groups
350177|NCT01120626|B2|Baseline|Sugar Pill|"sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)~sugar pill: sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)"
350178|NCT01120626|B1|Baseline|Donepezil|"donepezil (2.5 mg to 10.0 mg per day for 12 weeks)~donepezil: donepezil (2.5 mg to 10.0 mg per day for 12 weeks)"
350179|NCT01120626|P2|Participant Flow|Sugar Pill|"sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)~sugar pill: sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)"
350180|NCT01120626|P1|Participant Flow|Donepezil|"donepezil (2.5 mg to 10.0 mg per day for 12 weeks)~donepezil: donepezil (2.5 mg to 10.0 mg per day for 12 weeks)"
350181|NCT01120626|O2|Outcome|Sugar Pill|"sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)~sugar pill: sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)"
350650|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350186|NCT01120626|E1|Reported Event|Donepezil|"donepezil (2.5 mg to 10.0 mg per day for 12 weeks)~donepezil: donepezil (2.5 mg to 10.0 mg per day for 12 weeks)"
350187|NCT01120600|B3|Baseline|Total|Total of all reporting groups
350188|NCT01120600|B2|Baseline|Placebo Once Weekly|Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
350189|NCT01120600|B1|Baseline|Odanacatib 50 mg Once Weekly|Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
350190|NCT01120600|P2|Participant Flow|Placebo Once Weekly|Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
350191|NCT01120600|P1|Participant Flow|Odanacatib 50 mg Once Weekly|Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
350192|NCT01120600|O2|Outcome|Placebo Once Weekly|Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
350193|NCT01120600|O1|Outcome|Odanacatib 50 mg Once Weekly|Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
350194|NCT01120600|O2|Outcome|Placebo Once Weekly|Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
350195|NCT01120600|O1|Outcome|Odanacatib 50 mg Once Weekly|Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
350196|NCT01120600|O2|Outcome|Placebo Once Weekly|Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
350197|NCT01120600|O1|Outcome|Odanacatib 50 mg Once Weekly|Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
350198|NCT01120600|O2|Outcome|Placebo Once Weekly|Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
350199|NCT01120600|O1|Outcome|Odanacatib 50 mg Once Weekly|Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
350200|NCT01120600|O2|Outcome|Placebo Once Weekly|Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
350201|NCT01120600|O1|Outcome|Odanacatib 50 mg Once Weekly|Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
350202|NCT01120600|O2|Outcome|Placebo Once Weekly|Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
350203|NCT01120600|O1|Outcome|Odanacatib 50 mg Once Weekly|Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
350204|NCT01120600|O2|Outcome|Placebo Once Weekly|Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
350205|NCT01120600|O1|Outcome|Odanacatib 50 mg Once Weekly|Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
350206|NCT01120600|O2|Outcome|Placebo Once Weekly|Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
350250|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
352928|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
350207|NCT01120600|O1|Outcome|Odanacatib 50 mg Once Weekly|Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
350208|NCT01120600|O2|Outcome|Placebo Once Weekly|Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
350209|NCT01120600|O1|Outcome|Odanacatib 50 mg Once Weekly|Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
350210|NCT01120600|O2|Outcome|Placebo Once Weekly|Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
350211|NCT01120600|O1|Outcome|Odanacatib 50 mg Once Weekly|Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
350212|NCT01120600|E2|Reported Event|Placebo Once Weekly|Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
350213|NCT01120600|E1|Reported Event|Odanacatib 50 mg Once Weekly|Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
350214|NCT01120405|B3|Baseline|Total|Total of all reporting groups
350215|NCT01120405|B2|Baseline|Sevoflurane|0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group B)
350216|NCT01120405|B1|Baseline|Xenon|0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group A)
350217|NCT01120405|P2|Participant Flow|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
350218|NCT01120405|P1|Participant Flow|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
350219|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
350220|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
350221|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
350222|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
350223|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group B)
350224|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group A)
350225|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
350226|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
350227|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
350228|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
350229|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
350230|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
350231|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
350232|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
350233|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
350234|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
350235|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
350236|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
350237|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
350238|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
350239|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
350240|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
350241|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
350242|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
350243|NCT01120405|E2|Reported Event|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
350244|NCT01120405|E1|Reported Event|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
350245|NCT01120379|B1|Baseline|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350246|NCT01120379|P1|Participant Flow|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350247|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350248|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350249|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
352929|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
350251|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350252|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350253|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350254|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350255|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350256|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350257|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350258|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350259|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350260|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350261|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350262|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350263|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350264|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350265|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350266|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350267|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350268|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350269|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350270|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350271|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350272|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350273|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350274|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350275|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350276|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350277|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350278|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350279|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350280|NCT01120379|E1|Reported Event|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
350281|NCT01120275|B1|Baseline|Treatment (Gamma-secretase Inhibitor RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~laboratory biomarker analysis: Correlative studies"
350282|NCT01120275|P1|Participant Flow|Treatment (Gamma-secretase Inhibitor RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~laboratory biomarker analysis: Correlative studies"
350303|NCT01120236|O2|Outcome|CTC= 1-4|1 to 4 CTCs found in 7.5 mL blood sample collected at baseline, pooled treatment arms
350283|NCT01120275|O1|Outcome|RO4929097|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~laboratory biomarker analysis: Correlative studies"
350284|NCT01120275|O1|Outcome|Treatment (Gamma-secretase Inhibitor RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~laboratory biomarker analysis: Correlative studies"
350285|NCT01120275|O1|Outcome|Treatment (Gamma-secretase Inhibitor RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~laboratory biomarker analysis: Correlative studies"
350286|NCT01120275|O1|Outcome|Treatment (Gamma-secretase Inhibitor RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~laboratory biomarker analysis: Correlative studies"
350287|NCT01120275|E1|Reported Event|RO4929097|Patients receive gamma-secretase/Notch signaling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
350288|NCT01120236|B3|Baseline|Total|Total of all reporting groups
350289|NCT01120236|B2|Baseline|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
350290|NCT01120236|B1|Baseline|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO~Cixutumumab: Given IV~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
350291|NCT01120236|P2|Participant Flow|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
350292|NCT01120236|P1|Participant Flow|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO~Cixutumumab: Given IV~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
350293|NCT01120236|O2|Outcome|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
350294|NCT01120236|O1|Outcome|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO~Cixutumumab: Given IV~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
350295|NCT01120236|O2|Outcome|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
350296|NCT01120236|O1|Outcome|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO~Cixutumumab: Given IV~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
350297|NCT01120236|O2|Outcome|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
350298|NCT01120236|O1|Outcome|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO~Cixutumumab: Given IV~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
350299|NCT01120236|O3|Outcome|CTC= 5+|Five or more CTCs were found in 7.5 mL blood sample collected at baseline, pooled treatment arms
350300|NCT01120236|O2|Outcome|CTC= 1-4|1 to 4 CTCs found in 7.5 mL blood sample collected at baseline, pooled treatment arms
350301|NCT01120236|O1|Outcome|CTC=0|No CTCs foundin 7.5 mL blood sample collected at baseline, pooled treatment arms
350302|NCT01120236|O3|Outcome|CTC= 5+|Five or more CTCs were found in 7.5 mL blood sample collected at baseline, pooled treatment arms
350305|NCT01120236|O3|Outcome|PSA Non-Responders|Patients who had a PSA level of > 4.0 ng/mL at 28 weeks after registration, pooled treatment Arm I (androgen deprivation and cixutumumab) & Arm II (androgen deprivation therapy)
350306|NCT01120236|O2|Outcome|PSA Partial Response|Patients who had a PSA level of >0.2 ng/mL and <= 4.0 ng/mL at 28 weeks after registration, pooled treatment Arm I (androgen deprivation and cixutumumab) & Arm II (androgen deprivation therapy)
350307|NCT01120236|O1|Outcome|PSA Complete Response|Patients who had a PSA level of ≤ 0.2 ng/mL at 28 weeks after registration, pooled treatment Arm I (androgen deprivation and cixutumumab) & Arm II (androgen deprivation therapy)
350308|NCT01120236|O2|Outcome|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
350309|NCT01120236|O1|Outcome|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO~Cixutumumab: Given IV~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
350310|NCT01120236|O2|Outcome|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
350311|NCT01120236|O1|Outcome|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO~Cixutumumab: Given IV~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
350312|NCT01120236|O2|Outcome|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given IM Pharmacological Study: Correlative studies"
350313|NCT01120236|O1|Outcome|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO Cixutumumab: Given IV Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given IM Pharmacological Study: Correlative studies"
350314|NCT01120236|O2|Outcome|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
350315|NCT01120236|O1|Outcome|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO~Cixutumumab: Given IV~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
350316|NCT01120236|E2|Reported Event|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given IM Pharmacological Study: Correlative studies"
350317|NCT01120236|E1|Reported Event|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO Cixutumumab: Given IV Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given IM Pharmacological Study: Correlative studies"
350318|NCT01120223|B1|Baseline|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350319|NCT01120223|P1|Participant Flow|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350320|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350321|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350322|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350323|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
352930|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
350324|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350325|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350326|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350327|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350328|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350329|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350330|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350331|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350332|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350333|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350334|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350335|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350336|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350337|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350338|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350339|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350340|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350341|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350342|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350343|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350344|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350345|NCT01120223|E1|Reported Event|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
350346|NCT01120210|B3|Baseline|Total|Total of all reporting groups
350347|NCT01120210|B2|Baseline|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
350348|NCT01120210|B1|Baseline|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
350374|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
350349|NCT01120210|P2|Participant Flow|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
350350|NCT01120210|P1|Participant Flow|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
350351|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
350352|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
350353|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
350354|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
350355|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
350356|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
350357|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
350358|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
350359|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
350360|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
350361|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
350362|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
350363|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
350364|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
350365|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
350366|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
350367|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
350368|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
350369|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
350370|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
350371|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
350372|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
350373|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
350375|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
350376|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
350377|NCT01120210|E2|Reported Event|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
350378|NCT01120210|E1|Reported Event|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
350379|NCT01120197|B3|Baseline|Total|Total of all reporting groups
350380|NCT01120197|B2|Baseline|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities"
350381|NCT01120197|B1|Baseline|Exercise Group|: Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
350382|NCT01120197|P2|Participant Flow|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities"
350383|NCT01120197|P1|Participant Flow|Exercise Group|"Exercise Group: Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).~The intervention is in accordance with Rehabilitation treatment guidelines in postmenupausal and senile osteoporosis ( Bonaiuti et al. 2005)."
350384|NCT01120197|O2|Outcome|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities."
350385|NCT01120197|O1|Outcome|Exercise Group|Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
350386|NCT01120197|O2|Outcome|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities."
350387|NCT01120197|O1|Outcome|Exercise Group|Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
350388|NCT01120197|O2|Outcome|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities. [We recommend specifying length of time they are followed]"
350389|NCT01120197|O1|Outcome|Exercise Group|Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
350390|NCT01120197|O2|Outcome|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities."
350391|NCT01120197|O1|Outcome|Exercise Group|Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
350651|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350652|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350392|NCT01120197|O2|Outcome|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities. [We recommend specifying length of time they are followed]"
350393|NCT01120197|O1|Outcome|Exercise Group|Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
350394|NCT01120197|E2|Reported Event|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities."
350395|NCT01120197|E1|Reported Event|Exercise Group|Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
350396|NCT01120184|B4|Baseline|Total|Total of all reporting groups
350397|NCT01120184|B3|Baseline|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350398|NCT01120184|B2|Baseline|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350399|NCT01120184|B1|Baseline|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350400|NCT01120184|P3|Participant Flow|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350401|NCT01120184|P2|Participant Flow|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350402|NCT01120184|P1|Participant Flow|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350403|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350404|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350405|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350406|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350653|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350654|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
350407|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350408|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350409|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350410|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350411|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350412|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350413|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350414|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350415|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350416|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350417|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350418|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350419|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350420|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350421|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350422|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350423|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350424|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350425|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350426|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350427|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350428|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350429|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350430|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350431|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350432|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350433|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350434|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350655|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
350656|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
350657|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350435|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350436|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350437|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350438|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350439|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350440|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350441|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350442|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350443|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350444|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350445|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350446|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350447|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350562|NCT01120067|E1|Reported Event|Intensive Treatment|"Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain~Intensive Treatment: Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration."
350448|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350449|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350450|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350451|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350452|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350453|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350454|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350455|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350456|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350457|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350458|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350459|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350460|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350461|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350563|NCT01119963|B3|Baseline|Total|Total of all reporting groups
350658|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350659|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350462|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350463|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350464|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350465|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350466|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350467|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350468|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350469|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350470|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350471|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350472|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350473|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350474|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350564|NCT01119963|B2|Baseline|Placebo|"Castor Oil (Placebo)intramuscular (IM) weekly~Castor Oil (Placebo): IM injections of Placebo (castor oil) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first."
350660|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350475|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350476|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350477|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350478|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350479|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350480|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350481|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350482|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350483|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350484|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350485|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350486|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350487|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350488|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350661|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350662|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
350663|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
350489|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350490|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350491|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350492|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350493|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350494|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350495|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350496|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350497|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350498|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350499|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350500|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350501|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350565|NCT01119963|B1|Baseline|17-alpha Hydroxyprogesterone Caproate, Makena®|"250 mg of 17P, Makena® intramuscular (IM) weekly.~17-alpha-hydroxy-progesterone caproate, Makena®: Intramuscular (IM) injection of 17P,Makena® (250mg) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first."
350502|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350503|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350504|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350505|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350506|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350507|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350508|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350509|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350510|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350511|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350512|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350513|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350514|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350515|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350664|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
350665|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350666|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350516|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350517|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350518|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350519|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350520|NCT01120184|E3|Reported Event|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350521|NCT01120184|E2|Reported Event|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
350522|NCT01120184|E1|Reported Event|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
350523|NCT01120093|B1|Baseline|Overall Study Population|All patients randomized into the crossover study
350524|NCT01120093|P5|Participant Flow|Placebo;Aclidinium100;Formoterol;Aclidinium200;Aclidinium400|"The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.~In period 1, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 2, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 3, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 4, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 5, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days."
350525|NCT01120093|P4|Participant Flow|Formoterol;Placebo;Aclidinium400;Aclidinium100;Aclidinium200|"The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.~In period 1, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 2, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 3, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 4, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 5, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days."
350526|NCT01120093|P3|Participant Flow|Aclidinium400;Formoterol;Aclidinium200;Placebo;Aclidinium100|"The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.~In period 1, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 2, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 3, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 4, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 5, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days."
350566|NCT01119963|P2|Participant Flow|Placebo|"Castor Oil (Placebo)intramuscular (IM) weekly~Castor Oil (Placebo): IM injections of Placebo (castor oil) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first."
350667|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350527|NCT01120093|P2|Participant Flow|Aclidinium200;Aclidinium400;Aclidinium100;Formoterol;Placebo|"The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.~In period 1, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 2, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 3, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 4, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 5, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days."
350528|NCT01120093|P1|Participant Flow|Aclidinium100;Aclidinium200;Placebo;Aclidinium400;Formoterol|"The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.~In period 1, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 2, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 3, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 4, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 5, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days."
350529|NCT01120093|O5|Outcome|Placebo|Placebo via inhalation
350530|NCT01120093|O4|Outcome|Formoterol 12 μg Bid|Formoterol 12 μg twice-daily via inhalation
350531|NCT01120093|O3|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
350532|NCT01120093|O2|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
350533|NCT01120093|O1|Outcome|Aclidinium Bromide 100 μg Bid|Aclidinium bromide 100 μg twice-daily via inhalation
350534|NCT01120093|O5|Outcome|Placebo|Placebo via inhalation
350535|NCT01120093|O4|Outcome|Formoterol 12 μg Bid|Formoterol 12 μg twice-daily via inhalation
350536|NCT01120093|O3|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
350537|NCT01120093|O2|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
350538|NCT01120093|O1|Outcome|Aclidinium Bromide 100 μg Bid|Aclidinium bromide 100 μg twice-daily via inhalation
350539|NCT01120093|O5|Outcome|Placebo|Placebo via inhalation
350540|NCT01120093|O4|Outcome|Formoterol 12 μg Bid|Formoterol 12 μg twice-daily via inhalation
350541|NCT01120093|O3|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
350542|NCT01120093|O2|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
350543|NCT01120093|O1|Outcome|Aclidinium Bromide 100 μg Bid|Aclidinium bromide 100 μg twice-daily via inhalation
350544|NCT01120093|O5|Outcome|Placebo|Placebo via inhalation
350545|NCT01120093|O4|Outcome|Formoterol 12 μg Bid|Formoterol 12 μg twice-daily via inhalation
350546|NCT01120093|O3|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
350547|NCT01120093|O2|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
350548|NCT01120093|O1|Outcome|Aclidinium Bromide 100 μg Bid|Aclidinium bromide 100 μg twice-daily via inhalation
350549|NCT01120093|E5|Reported Event|Placebo|Inhaled placebo dose for 7 days.
350550|NCT01120093|E4|Reported Event|Formoterol 12 μg Bid|Formoterol 12 μg twice-daily via inhalation by Aerolizer® inhaler at 09:00 (± 30 mins) and 21:00 (± 30 mins) for 7 days.
350551|NCT01120093|E3|Reported Event|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days.
350552|NCT01120093|E2|Reported Event|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days.
350553|NCT01120093|E1|Reported Event|Aclidinium Bromide 100 μg Bid|Aclidinium bromide 100 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days.
350554|NCT01120067|B3|Baseline|Total|Total of all reporting groups
350555|NCT01120067|B2|Baseline|Treatment as Usual|"Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD~Treatment as Usual: Treatment as Usual."
350556|NCT01120067|B1|Baseline|Intensive Treatment|"Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain~Intensive Treatment: Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration."
350557|NCT01120067|P2|Participant Flow|Treatment as Usual|"Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD~Treatment as Usual: Treatment as Usual."
350558|NCT01120067|P1|Participant Flow|Intensive Treatment|"Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain~Intensive Treatment: Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration."
350559|NCT01120067|O2|Outcome|Treatment as Usual|"Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD~Treatment as Usual: Treatment as Usual."
350560|NCT01120067|O1|Outcome|Intensive Treatment|"Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain~Intensive Treatment: Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration."
350561|NCT01120067|E2|Reported Event|Treatment as Usual|"Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD~Treatment as Usual: Treatment as Usual."
350567|NCT01119963|P1|Participant Flow|17-alpha Hydroxyprogesterone Caproate, Makena®|"250 mg of 17P, Makena® intramuscular (IM) weekly.~17-alpha-hydroxy-progesterone caproate, Makena®: Intramuscular (IM) injection of 17P,Makena® (250mg) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first."
350568|NCT01119963|O2|Outcome|Placebo|"Castor Oil (Placebo)intramuscular (IM) weekly~Castor Oil (Placebo): IM injections of Placebo (castor oil) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first."
350569|NCT01119963|O1|Outcome|17-alpha Hydroxyprogesterone Caproate, Makena®|"250 mg of 17P, Makena® intramuscular (IM) weekly.~17-alpha-hydroxy-progesterone caproate, Makena®: Intramuscular (IM) injection of 17P,Makena® (250mg) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first."
350570|NCT01119963|O2|Outcome|Placebo|"Castor Oil (Placebo)intramuscular (IM) weekly~Castor Oil (Placebo): IM injections of Placebo (castor oil) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first."
350571|NCT01119963|O1|Outcome|17-alpha Hydroxyprogesterone Caproate, Makena®|"250 mg of 17P, Makena® intramuscular (IM) weekly.~17-alpha-hydroxy-progesterone caproate, Makena®: Intramuscular (IM) injection of 17P,Makena® (250mg) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first."
350572|NCT01119963|E2|Reported Event|Placebo|"Castor Oil (Placebo)intramuscular (IM) weekly~Castor Oil (Placebo): IM injections of Placebo (castor oil) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first."
350573|NCT01119963|E1|Reported Event|17-alpha Hydroxyprogesterone Caproate, Makena®|"250 mg of 17P, Makena® intramuscular (IM) weekly.~17-alpha-hydroxy-progesterone caproate, Makena®: Intramuscular (IM) injection of 17P,Makena® (250mg) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first."
350574|NCT01119950|B1|Baseline|All Participants|All participants in the safety set
350575|NCT01119950|P1|Participant Flow|Overall Study|"For the overall study, 388 participants were randomized and 1 non-randomized participant received drug in error and was discontinued. This participant was excluded from randomized number of patients but included in number of treated participants and in the safety set.~Out of the 388 participants randomized, 341 completed study treatment and 47 discontinued, including 3 misrandomized participants who did not receive any study medication."
350576|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
350577|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350578|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350579|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350580|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350581|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350582|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
350583|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
350584|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
350585|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350586|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350587|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350588|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350589|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350590|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
350591|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
350592|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
350593|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350594|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350595|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350596|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350597|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350598|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
350599|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
350600|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
350601|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350602|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350603|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350604|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350605|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350606|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
350607|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
350608|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
350609|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350610|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350611|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350612|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350613|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350614|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
350615|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
350616|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
350617|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350618|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350619|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350620|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350621|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350668|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350669|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350670|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
350671|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
350672|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
350673|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350674|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350675|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350676|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350677|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350678|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
350679|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
350680|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
350681|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350682|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350683|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350684|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350685|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350686|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
350687|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
350688|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
350689|NCT01119950|O7|Outcome|NVA237 50 ug b.i.d.|NVA237 50 ug twice daily
350690|NCT01119950|O6|Outcome|NVA237 100 ug q.d.|NVA237 100 ug once daily
350691|NCT01119950|O5|Outcome|NVA237 25 ug b.i.d.|NVA237 25 ug twice daily
350692|NCT01119950|O4|Outcome|NVA237 50 ug q.d.|NVA237 50 ug once daily
350693|NCT01119950|O3|Outcome|NVA237 12.5 ug b.i.d.|NVA237 12.5 ug twice daily
350694|NCT01119950|O2|Outcome|NVA237 25 ug q.d.|NVA237 12.5 ug once daily
350695|NCT01119950|O1|Outcome|NVA237 12.5 ug q.d.|NVA237 25 ug once daily
350696|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350697|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350698|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350699|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350700|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350701|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
350702|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
350703|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
350704|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350705|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350706|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350707|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350708|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350709|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
350710|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
350711|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350712|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350713|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350714|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350715|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350716|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
350717|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
350718|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350719|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350720|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350721|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350722|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350723|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
350724|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
350725|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350726|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350727|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350728|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350729|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350730|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
350731|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
350732|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350733|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350734|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350735|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350736|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350737|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
350738|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
350739|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350740|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350741|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350742|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350743|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350744|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
350745|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
350746|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350747|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350748|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350749|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350750|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350751|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
350752|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
350753|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350754|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350755|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350756|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350757|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350758|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
350759|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
350760|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350761|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350762|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350763|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350764|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350765|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
350766|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
350767|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350768|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350769|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350770|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350771|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350772|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
350773|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
350774|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350775|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350776|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350777|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350778|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350779|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
350780|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
350781|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350782|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350783|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350784|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350785|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350786|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
350787|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
350788|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350789|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350790|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350791|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350792|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350793|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
350794|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
350795|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350796|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350797|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350798|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350799|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350800|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
350801|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
350802|NCT01119950|O1|Outcome|Overall Study|A statistical modeling process was used to achieve the key objective. A set of 4 candidate models based on the Emax dose-response shape was derived plus their sigmoidal Emax counterparts (a total of 8 models) that describe the evolution of dose response over time. A model-averaging process was then employed to obtain response predictions as the weighted average of individual model predictions and confidence limits derived using a simulation-based procedure.
350803|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
350804|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
350805|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
350806|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
350807|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
350808|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
350809|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
350810|NCT01119950|O1|Outcome|Overall Study|A statistical modeling process was used to achieve the key objective. A set of 4 candidate models based on the Emax dose-response shape was derived plus their sigmoidal Emax counterparts (a total of 8 models) that describe the evolution of dose response over time. A model-averaging process was then employed to obtain response predictions as the weighted average of individual model predictions and confidence limits derived using a simulation-based procedure.
350812|NCT01119950|E7|Reported Event|NVA237 50 ug b.i.d.|NVA237 50 ug b.i.d.
350813|NCT01119950|E6|Reported Event|NVA237 100 ug q.d.|NVA237 100 ug q.d.
350814|NCT01119950|E5|Reported Event|NVA237 25 ug b.i.d.|NVA237 25 ug b.i.d.
350815|NCT01119950|E4|Reported Event|NVA237 50 ug q.d.|NVA237 50 ug q.d.
350816|NCT01119950|E3|Reported Event|NVA237 12.5 ug b.i.d.|NVA237 12.5 ug b.i.d.
350817|NCT01119950|E2|Reported Event|NVA237 25 ug q.d.|NVA237 25 ug q.d.
350818|NCT01119950|E1|Reported Event|NVA237 12.5 ug q.d.|NVA237 12.5 ug q.d.
350819|NCT01119937|B3|Baseline|Total|Total of all reporting groups
350820|NCT01119937|B2|Baseline|Tiotropium|18µg once daily
350821|NCT01119937|B1|Baseline|NVA237|50µg once daily
350822|NCT01119937|P2|Participant Flow|Tiotropium|18µg once daily
350823|NCT01119937|P1|Participant Flow|NVA237|50µg once daily
350824|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
350825|NCT01119937|O1|Outcome|NVA237|50µg once daily
350826|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
350827|NCT01119937|O1|Outcome|NVA237|50µg once daily
350828|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
350829|NCT01119937|O1|Outcome|NVA237|50µg once daily
350830|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
350831|NCT01119937|O1|Outcome|NVA237|50µg once daily
350832|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
350833|NCT01119937|O1|Outcome|NVA237|50µg once daily
350834|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
350835|NCT01119937|O1|Outcome|NVA237|50µg once daily
350836|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
350837|NCT01119937|O1|Outcome|NVA237|50µg once daily
350838|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
350839|NCT01119937|O1|Outcome|NVA237|50µg once daily
350840|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
350841|NCT01119937|O1|Outcome|NVA237|50µg once daily
350842|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
350843|NCT01119937|O1|Outcome|NVA237|50µg once daily
350844|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
350845|NCT01119937|O1|Outcome|NVA237|50µg once daily
350846|NCT01119937|E2|Reported Event|Tiotropium|18µg once daily
350847|NCT01119937|E1|Reported Event|NVA237|50µg once daily
350848|NCT01119859|B3|Baseline|Total|Total of all reporting groups
350849|NCT01119859|B2|Baseline|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
350850|NCT01119859|B1|Baseline|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
350851|NCT01119859|P2|Participant Flow|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
350852|NCT01119859|P1|Participant Flow|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
350853|NCT01119859|O2|Outcome|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
350854|NCT01119859|O1|Outcome|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
350855|NCT01119859|O2|Outcome|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
350856|NCT01119859|O1|Outcome|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
350857|NCT01119859|O2|Outcome|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
350858|NCT01119859|O1|Outcome|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
350859|NCT01119859|O2|Outcome|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
350860|NCT01119859|O1|Outcome|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
350861|NCT01119859|O2|Outcome|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
350862|NCT01119859|O1|Outcome|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
350863|NCT01119859|O2|Outcome|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
350864|NCT01119859|O1|Outcome|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
350865|NCT01119859|E2|Reported Event|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
350866|NCT01119859|E1|Reported Event|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
350867|NCT01119846|B4|Baseline|Total|Total of all reporting groups
350931|NCT01119846|O3|Outcome|Part A: GSK1292263 150 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 150 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
352931|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
350868|NCT01119846|B3|Baseline|Part C|Participants were randomized to 14 days of dosing with 4 dose regimens of GSK1292263 (final doses were: 50 mg BID, 150 mg BID, 300 mg BID, and 600 mg once daily) or matching placebo (administered BID) or open-label sitagliptin 100 mg (dosed once daily with the morning dose of GSK1292263). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa.
350869|NCT01119846|B2|Baseline|Part B|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fasted or fed condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 minutes (min) after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
350870|NCT01119846|B1|Baseline|Part A|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive escalating doses of GSK1292263 25 mg, 150 mg and 800 mg in each of 3 periods along with placebo and sitagliptin 100 mg orally in the other 2 periods in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350871|NCT01119846|P3|Participant Flow|Part C|Participants were randomized to 14 days of dosing with 4 dose regimens of GSK1292263 (final doses were: 50 mg twice daily [BID], 150 mg BID, 300 mg BID, and 600 mg once daily) or matching placebo (administered BID) or open-label sitagliptin 100 mg (dosed once daily with the morning dose of GSK1292263). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350872|NCT01119846|P2|Participant Flow|Part B|In this part (Cohort 2), after the appropriate washout period, T2DM participants on monotherapy or sub-maximal anti-diabetic medications were randomized to receive a single dose of GSK1292263 800 mg orally in fasted or fed condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 minutes after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
350873|NCT01119846|P1|Participant Flow|Part A|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive escalating doses of GSK1292263 25 milligrams (mg), 150 mg and 800 mg in each of 3 periods along with placebo and sitagliptin 100 mg orally in the other 2 periods in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the oral glucose tolerance test (OGTT).
350874|NCT01119846|O6|Outcome|Part C: Sitagliptin 100 mg|Participants were randomized to 14 days of dosing with open-label sitagliptin 100 mg (dosed once daily with the morning dose of GSK1292263). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350875|NCT01119846|O5|Outcome|Part C: Placebo|Participants were randomized to 14 days of dosing with matching placebo (administered BID). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350876|NCT01119846|O4|Outcome|Part C: GSK1292263 600 mg Once Daily|Participants were randomized to 14 days of dosing GSK1292263 600 mg once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350877|NCT01119846|O3|Outcome|Part C: GSK1292263 300 mg BID|Participants were randomized to 14 days of dosing GSK1292263 300 mg BID. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350878|NCT01119846|O2|Outcome|Part C: GSK1292263 150 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 150 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350879|NCT01119846|O1|Outcome|Part C: GSK1292263 50 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 50 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350932|NCT01119846|O2|Outcome|Part A: GSK1292263 25 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 25 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
352932|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
350880|NCT01119846|O6|Outcome|Part C: Sitagliptin 100 mg|Participants were randomized to 14 days of dosing with open-label sitagliptin 100 mg (dosed once daily with the morning dose of GSK1292263). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350881|NCT01119846|O5|Outcome|Part C: Placebo|Participants were randomized to 14 days of dosing with matching placebo (administered BID). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350882|NCT01119846|O4|Outcome|Part C: GSK1292263 600 mg Once Daily|Participants were randomized to 14 days of dosing GSK1292263 600 mg once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350883|NCT01119846|O3|Outcome|Part C: GSK1292263 300 mg BID|Participants were randomized to 14 days of dosing GSK1292263 300 mg BID. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350884|NCT01119846|O2|Outcome|Part C: GSK1292263 150 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 150 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350885|NCT01119846|O1|Outcome|Part C: GSK1292263 50 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 50 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350886|NCT01119846|O6|Outcome|Part C: Sitagliptin 100 mg|Participants were randomized to 14 days of dosing with open-label sitagliptin 100 mg (dosed once daily with the morning dose of GSK1292263). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350887|NCT01119846|O5|Outcome|Part C: Placebo|Participants were randomized to 14 days of dosing with matching placebo (administered BID). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350888|NCT01119846|O4|Outcome|Part C: GSK1292263 600 mg Once Daily|Participants were randomized to 14 days of dosing GSK1292263 600 mg once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350889|NCT01119846|O3|Outcome|Part C: GSK1292263 300 mg BID|Participants were randomized to 14 days of dosing GSK1292263 300 mg BID. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350890|NCT01119846|O2|Outcome|Part C: GSK1292263 150 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 150 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350891|NCT01119846|O1|Outcome|Part C: GSK1292263 50 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 50 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350933|NCT01119846|O1|Outcome|Part A: Placebo|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive placebo orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351296|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
350892|NCT01119846|O2|Outcome|Part B: GSK1292263 800 mg Fed Condition Orally|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fed condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 min after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
350893|NCT01119846|O1|Outcome|Part B: GSK1292263 800 mg Fasted Condition Orally|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fasted condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 min after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
350894|NCT01119846|O2|Outcome|Part B: GSK1292263 800 mg Fed Condition Orally|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fed condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 min after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
350895|NCT01119846|O1|Outcome|Part B: GSK1292263 800 mg Fasted Condition Orally|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fasted condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 min after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
350896|NCT01119846|O2|Outcome|Part B: GSK1292263 800 mg Fed Condition Orally|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fed condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 min after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
350897|NCT01119846|O1|Outcome|Part B: GSK1292263 800 mg Fasted Condition Orally|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fasted condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 min after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
350898|NCT01119846|O2|Outcome|Part B: GSK1292263 800 mg Fed Condition Orally|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fed condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 min after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
350899|NCT01119846|O1|Outcome|Part B: GSK1292263 800 mg Fasted Condition Orally|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fasted condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 min after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
350900|NCT01119846|O2|Outcome|Part B: GSK1292263 800 mg Fed Condition Orally|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fed condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 min after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
350901|NCT01119846|O1|Outcome|Part B: GSK1292263 800 mg Fasted Condition Orally|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fasted condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 min after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
350902|NCT01119846|O2|Outcome|Part B: GSK1292263 800 mg Fed Condition Orally|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fed condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 min after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
350903|NCT01119846|O1|Outcome|Part B: GSK1292263 800 mg Fasted Condition Orally|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fasted condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 min after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
352933|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
350904|NCT01119846|O2|Outcome|Part B: GSK1292263 800 mg Fed Condition Orally|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fed condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 min after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
350905|NCT01119846|O1|Outcome|Part B: GSK1292263 800 mg Fasted Condition Orally|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fasted condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 min after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
350906|NCT01119846|O2|Outcome|Part B: GSK1292263 800 mg Fed Condition Orally|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fed condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 min after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
350907|NCT01119846|O1|Outcome|Part B: GSK1292263 800 mg Fasted Condition Orally|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fasted condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 min after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
350908|NCT01119846|O2|Outcome|Part B: GSK1292263 800 mg Fed Condition Orally|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fed condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 min after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
350909|NCT01119846|O1|Outcome|Part B: GSK1292263 800 mg Fasted Condition Orally|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fasted condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 min after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
350910|NCT01119846|O2|Outcome|Part B: GSK1292263 800 mg Fed Condition Orally|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fed condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 min after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
350911|NCT01119846|O1|Outcome|Part B: GSK1292263 800 mg Fasted Condition Orally|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fasted condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 min after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
350912|NCT01119846|O6|Outcome|Part C: Sitagliptin 100 mg|Participants were randomized to 14 days of dosing with open-label sitagliptin 100 mg (dosed once daily with the morning dose of GSK1292263). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350913|NCT01119846|O5|Outcome|Part C: Placebo|Participants were randomized to 14 days of dosing with matching placebo (administered BID). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350914|NCT01119846|O4|Outcome|Part C: GSK1292263 600 mg Once Daily|Participants were randomized to 14 days of dosing GSK1292263 600 mg once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350915|NCT01119846|O3|Outcome|Part C: GSK1292263 300 mg BID|Participants were randomized to 14 days of dosing GSK1292263 300 mg BID. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351120|NCT01119716|B1|Baseline|All Enrolled Participants|Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
350916|NCT01119846|O2|Outcome|Part C: GSK1292263 150 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 150 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350917|NCT01119846|O1|Outcome|Part C: GSK1292263 50 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 50 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350918|NCT01119846|O6|Outcome|Part C: Sitagliptin 100 mg|Participants were randomized to 14 days of dosing with open-label sitagliptin 100 mg (dosed once daily with the morning dose of GSK1292263). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350919|NCT01119846|O5|Outcome|Part C: Placebo|Participants were randomized to 14 days of dosing with matching placebo (administered BID). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350920|NCT01119846|O4|Outcome|Part C: GSK1292263 600 mg Once Daily|Participants were randomized to 14 days of dosing GSK1292263 600 mg once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350921|NCT01119846|O3|Outcome|Part C: GSK1292263 300 mg BID|Participants were randomized to 14 days of dosing GSK1292263 300 mg BID. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350922|NCT01119846|O2|Outcome|Part C: GSK1292263 150 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 150 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350923|NCT01119846|O1|Outcome|Part C: GSK1292263 50 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 50 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350924|NCT01119846|O5|Outcome|Part A: Sitagliptin 100 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive sitagliptin 100 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350925|NCT01119846|O4|Outcome|Part A: GSK1292263 800 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 800 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350926|NCT01119846|O3|Outcome|Part A: GSK1292263 150 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 150 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350927|NCT01119846|O2|Outcome|Part A: GSK1292263 25 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 25 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350928|NCT01119846|O1|Outcome|Part A: Placebo|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive placebo orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350929|NCT01119846|O5|Outcome|Part A: Sitagliptin 100 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive sitagliptin 100 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350930|NCT01119846|O4|Outcome|Part A: GSK1292263 800 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 800 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351199|NCT01119443|B3|Baseline|Total|Total of all reporting groups
350934|NCT01119846|O5|Outcome|Part A: Sitagliptin 100 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive sitagliptin 100 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350935|NCT01119846|O4|Outcome|Part A: GSK1292263 800 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 800 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350936|NCT01119846|O3|Outcome|Part A: GSK1292263 150 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 150 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350937|NCT01119846|O2|Outcome|Part A: GSK1292263 25 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 25 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350938|NCT01119846|O1|Outcome|Part A: Placebo|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive placebo orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350939|NCT01119846|O5|Outcome|Part A: Sitagliptin 100 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive sitagliptin 100 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350940|NCT01119846|O4|Outcome|Part A: GSK1292263 800 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 800 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350941|NCT01119846|O3|Outcome|Part A: GSK1292263 150 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 150 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350942|NCT01119846|O2|Outcome|Part A: GSK1292263 25 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 25 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350943|NCT01119846|O1|Outcome|Part A: Placebo|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive placebo orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350944|NCT01119846|O5|Outcome|Part A: Sitagliptin 100 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive sitagliptin 100 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350945|NCT01119846|O4|Outcome|Part A: GSK1292263 800 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 800 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350946|NCT01119846|O3|Outcome|Part A: GSK1292263 150 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 150 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350947|NCT01119846|O2|Outcome|Part A: GSK1292263 25 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 25 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350948|NCT01119846|O1|Outcome|Part A: Placebo|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive placebo orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350949|NCT01119846|O5|Outcome|Part A: Sitagliptin 100 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive sitagliptin 100 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350950|NCT01119846|O4|Outcome|Part A: GSK1292263 800 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 800 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350951|NCT01119846|O3|Outcome|Part A: GSK1292263 150 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 150 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350952|NCT01119846|O2|Outcome|Part A: GSK1292263 25 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 25 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351290|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
350953|NCT01119846|O1|Outcome|Part A: Placebo|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive placebo orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350954|NCT01119846|O5|Outcome|Part A: Sitagliptin 100 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive sitagliptin 100 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350955|NCT01119846|O4|Outcome|Part A: GSK1292263 800 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 800 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350956|NCT01119846|O3|Outcome|Part A: GSK1292263 150 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 150 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350957|NCT01119846|O2|Outcome|Part A: GSK1292263 25 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 25 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350958|NCT01119846|O1|Outcome|Part A: Placebo|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive placebo orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350959|NCT01119846|O5|Outcome|Part A: Sitagliptin 100 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive sitagliptin 100 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350960|NCT01119846|O4|Outcome|Part A: GSK1292263 800 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 800 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350961|NCT01119846|O3|Outcome|Part A: GSK1292263 150 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 150 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350962|NCT01119846|O2|Outcome|Part A: GSK1292263 25 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 25 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350963|NCT01119846|O1|Outcome|Part A: Placebo|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive placebo orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350964|NCT01119846|O5|Outcome|Part A: Sitagliptin 100 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive sitagliptin 100 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350965|NCT01119846|O4|Outcome|Part A: GSK1292263 800 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 800 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350966|NCT01119846|O3|Outcome|Part A: GSK1292263 150 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 150 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350967|NCT01119846|O2|Outcome|Part A: GSK1292263 25 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 25 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350968|NCT01119846|O1|Outcome|Part A: Placebo|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive placebo orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350969|NCT01119846|O6|Outcome|Part C: Sitagliptin 100 mg|Participants were randomized to 14 days of dosing with open-label sitagliptin 100 mg (dosed once daily with the morning dose of GSK1292263). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350970|NCT01119846|O5|Outcome|Part C: Placebo|Participants were randomized to 14 days of dosing with matching placebo (administered BID). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351291|NCT01119222|O1|Outcome|Gabapentin|Gabapentin single oral 1200 mg dose
350971|NCT01119846|O4|Outcome|Part C: GSK1292263 600 mg Once Daily|Participants were randomized to 14 days of dosing GSK1292263 600 mg once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350972|NCT01119846|O3|Outcome|Part C: GSK1292263 300 mg BID|Participants were randomized to 14 days of dosing GSK1292263 300 mg BID. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350973|NCT01119846|O2|Outcome|Part C: GSK1292263 150 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 150 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350974|NCT01119846|O1|Outcome|Part C: GSK1292263 50 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 50 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350975|NCT01119846|O5|Outcome|Part A: Sitagliptin 100 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive sitagliptin 100 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350976|NCT01119846|O4|Outcome|Part A: GSK1292263 800 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 800 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350977|NCT01119846|O3|Outcome|Part A: GSK1292263 150 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 150 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350978|NCT01119846|O2|Outcome|Part A: GSK1292263 25 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 25 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350979|NCT01119846|O1|Outcome|Part A: Placebo|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive placebo orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350980|NCT01119846|O3|Outcome|Part C: GSK1292263 600 mg Once Daily|Participants were randomized to 14 days of dosing GSK1292263 600 mg once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350981|NCT01119846|O2|Outcome|Part C: GSK1292263 300 mg BID|Participants were randomized to 14 days of dosing GSK1292263 300 mg BID. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350982|NCT01119846|O1|Outcome|Part C: GSK1292263 150 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 150 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350983|NCT01119846|O1|Outcome|Part C: GSK1292263 600 mg Once Daily|Participants were randomized to 14 days of dosing GSK1292263 600 mg once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350984|NCT01119846|O3|Outcome|Part C: GSK1292263 300 mg BID|Participants were randomized to 14 days of dosing GSK1292263 300 mg BID. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351035|NCT01119846|O1|Outcome|Part A: GSK1292263 25 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 25 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
350985|NCT01119846|O2|Outcome|Part C: GSK1292263 150 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 150 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350986|NCT01119846|O1|Outcome|Part C: GSK1292263 50 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 50 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350987|NCT01119846|O4|Outcome|Part C: GSK1292263 600 mg Once Daily|Participants were randomized to 14 days of dosing GSK1292263 600 mg once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350988|NCT01119846|O3|Outcome|Part C: GSK1292263 300 mg BID|Participants were randomized to 14 days of dosing GSK1292263 300 mg BID. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350989|NCT01119846|O2|Outcome|Part C: GSK1292263 150 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 150 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350990|NCT01119846|O1|Outcome|Part C: GSK1292263 50 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 50 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350991|NCT01119846|O4|Outcome|Part C: GSK1292263 600 mg Once Daily|Participants were randomized to 14 days of dosing GSK1292263 600 mg once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350992|NCT01119846|O3|Outcome|Part C: GSK1292263 300 mg BID|Participants were randomized to 14 days of dosing GSK1292263 300 mg BID. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350993|NCT01119846|O2|Outcome|Part C: GSK1292263 150 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 150 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350994|NCT01119846|O1|Outcome|Part C: GSK1292263 50 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 50 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350995|NCT01119846|O4|Outcome|Part C: GSK1292263 600 mg Once Daily|Participants were randomized to 14 days of dosing GSK1292263 600 mg once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350996|NCT01119846|O3|Outcome|Part C: GSK1292263 300 mg BID|Participants were randomized to 14 days of dosing GSK1292263 300 mg BID. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350997|NCT01119846|O2|Outcome|Part C: GSK1292263 150 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 150 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350998|NCT01119846|O1|Outcome|Part C: GSK1292263 50 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 50 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
350999|NCT01119846|O4|Outcome|Part C: GSK1292263 600 mg Once Daily|Participants were randomized to 14 days of dosing GSK1292263 600 mg once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351000|NCT01119846|O3|Outcome|Part C: GSK1292263 300 mg BID|Participants were randomized to 14 days of dosing GSK1292263 300 mg BID. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351001|NCT01119846|O2|Outcome|Part C: GSK1292263 150 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 150 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351002|NCT01119846|O1|Outcome|Part C: GSK1292263 50 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 50 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351003|NCT01119846|O6|Outcome|Part C: Sitagliptin 100 mg|Participants were randomized to 14 days of dosing with open-label sitagliptin 100 mg (dosed once daily with the morning dose of GSK1292263). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351004|NCT01119846|O5|Outcome|Part C: Placebo|Participants were randomized to 14 days of dosing with matching placebo (administered BID). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351005|NCT01119846|O4|Outcome|Part C: GSK1292263 600 mg Once Daily|Participants were randomized to 14 days of dosing GSK1292263 600 mg once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351006|NCT01119846|O3|Outcome|Part C: GSK1292263 300 mg BID|Participants were randomized to 14 days of dosing GSK1292263 300 mg BID. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351007|NCT01119846|O2|Outcome|Part C: GSK1292263 150 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 150 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351008|NCT01119846|O1|Outcome|Part C: GSK1292263 50 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 50 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351009|NCT01119846|O6|Outcome|Part C: Sitagliptin 100 mg|Participants were randomized to 14 days of dosing with open-label sitagliptin 100 mg (dosed once daily with the morning dose of GSK1292263). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351036|NCT01119846|O3|Outcome|Part A: GSK1292263 800 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 800 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351292|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
351010|NCT01119846|O5|Outcome|Part C: Placebo|Participants were randomized to 14 days of dosing with matching placebo (administered BID). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351011|NCT01119846|O4|Outcome|Part C: GSK1292263 600 mg Once Daily|Participants were randomized to 14 days of dosing GSK1292263 600 mg once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351012|NCT01119846|O3|Outcome|Part C: GSK1292263 300 mg BID|Participants were randomized to 14 days of dosing GSK1292263 300 mg BID. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351013|NCT01119846|O2|Outcome|Part C: GSK1292263 150 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 150 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351014|NCT01119846|O1|Outcome|Part C: GSK1292263 50 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 50 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351015|NCT01119846|O6|Outcome|Part C: Sitagliptin 100 mg|Participants were randomized to 14 days of dosing with open-label sitagliptin 100 mg (dosed once daily with the morning dose of GSK1292263). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351016|NCT01119846|O5|Outcome|Part C: Placebo|Participants were randomized to 14 days of dosing with matching placebo (administered BID). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351017|NCT01119846|O4|Outcome|Part C: GSK1292263 600 mg Once Daily|Participants were randomized to 14 days of dosing GSK1292263 600 mg once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351018|NCT01119846|O3|Outcome|Part C: GSK1292263 300 mg BID|Participants were randomized to 14 days of dosing GSK1292263 300 mg BID. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351019|NCT01119846|O2|Outcome|Part C: GSK1292263 150 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 150 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351020|NCT01119846|O1|Outcome|Part C: GSK1292263 50 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 50 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351021|NCT01119846|O6|Outcome|Part C: Sitagliptin 100 mg|Participants were randomized to 14 days of dosing with open-label sitagliptin 100 mg (dosed once daily with the morning dose of GSK1292263). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351037|NCT01119846|O2|Outcome|Part A: GSK1292263 150 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 150 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351293|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
351022|NCT01119846|O5|Outcome|Part C: Placebo|Participants were randomized to 14 days of dosing with matching placebo (administered BID). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351023|NCT01119846|O4|Outcome|Part C: GSK1292263 600 mg Once Daily|Participants were randomized to 14 days of dosing GSK1292263 600 mg once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351024|NCT01119846|O3|Outcome|Part C: GSK1292263 300 mg BID|Participants were randomized to 14 days of dosing GSK1292263 300 mg BID. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351025|NCT01119846|O2|Outcome|Part C: GSK1292263 150 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 150 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351026|NCT01119846|O1|Outcome|Part C: GSK1292263 50 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 50 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351027|NCT01119846|O6|Outcome|Part C: Sitagliptin 100 mg|Participants were randomized to 14 days of dosing with open-label sitagliptin 100 mg (dosed once daily with the morning dose of GSK1292263). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351028|NCT01119846|O5|Outcome|Part C: Placebo|Participants were randomized to 14 days of dosing with matching placebo (administered BID). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351029|NCT01119846|O4|Outcome|Part C: GSK1292263 600 mg Once Daily|Participants were randomized to 14 days of dosing GSK1292263 600 mg once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351030|NCT01119846|O3|Outcome|Part C: GSK1292263 300 mg BID|Participants were randomized to 14 days of dosing GSK1292263 300 mg BID. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351031|NCT01119846|O2|Outcome|Part C: GSK1292263 150 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 150 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351032|NCT01119846|O1|Outcome|Part C: GSK1292263 50 mg BID|Participants were randomized to 14 days of dosing with GSK1292263 50 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351033|NCT01119846|O3|Outcome|Part A: GSK1292263 800 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 800 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351034|NCT01119846|O2|Outcome|Part A: GSK1292263 150 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 150 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351107|NCT01119768|E2|Reported Event|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
351108|NCT01119768|E1|Reported Event|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
351109|NCT01119755|B1|Baseline|Group 1|
351038|NCT01119846|O1|Outcome|Part A: GSK1292263 25 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 25 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351039|NCT01119846|O3|Outcome|Part A: GSK1292263 800 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 800 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351040|NCT01119846|O2|Outcome|Part A: GSK1292263 150 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 150 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351041|NCT01119846|O1|Outcome|Part A: GSK1292263 25 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 25 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351042|NCT01119846|O5|Outcome|Part A: Sitagliptin 100 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive sitagliptin 100 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351043|NCT01119846|O4|Outcome|Part A: GSK1292263 800 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 800 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351044|NCT01119846|O3|Outcome|Part A: GSK1292263 150 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 150 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351045|NCT01119846|O2|Outcome|Part A: GSK1292263 25 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 25 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351046|NCT01119846|O1|Outcome|Part A: Placebo|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive placebo orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351047|NCT01119846|O5|Outcome|Part A: Sitagliptin 100 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive sitagliptin 100 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351048|NCT01119846|O4|Outcome|Part A: GSK1292263 800 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 800 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351049|NCT01119846|O3|Outcome|Part A: GSK1292263 150 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 150 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351050|NCT01119846|O2|Outcome|Part A: GSK1292263 25 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 25 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351051|NCT01119846|O1|Outcome|Part A: Placebo|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive placebo orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351052|NCT01119846|O5|Outcome|Part A: Sitagliptin 100 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive sitagliptin 100 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351053|NCT01119846|O4|Outcome|Part A: GSK1292263 800 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 800 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351054|NCT01119846|O3|Outcome|Part A: GSK1292263 150 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 150 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351055|NCT01119846|O2|Outcome|Part A: GSK1292263 25 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 25 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351056|NCT01119846|O1|Outcome|Part A: Placebo|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive placebo orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351110|NCT01119755|P1|Participant Flow|Group 1|
351111|NCT01119755|O1|Outcome|Group 1|
351057|NCT01119846|O5|Outcome|Part A: Sitagliptin 100 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive sitagliptin 100 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351058|NCT01119846|O4|Outcome|Part A: GSK1292263 800 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 800 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351059|NCT01119846|O3|Outcome|Part A: GSK1292263 150 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 150 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351060|NCT01119846|O2|Outcome|Part A: GSK1292263 25 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 25 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351061|NCT01119846|O1|Outcome|Part A: Placebo|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive placebo orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351062|NCT01119846|O5|Outcome|Part A: Sitagliptin 100 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive sitagliptin 100 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351063|NCT01119846|O4|Outcome|Part A: GSK1292263 800 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 800 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351064|NCT01119846|O3|Outcome|Part A: GSK1292263 150 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 150 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351065|NCT01119846|O2|Outcome|Part A: GSK1292263 25 mg|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 25 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351066|NCT01119846|O1|Outcome|Part A: Placebo|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive placebo orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351067|NCT01119846|E13|Reported Event|Part C: Sitagliptin 100 mg Once Daily Orally|Participants were randomized to 14 days of dosing with open-label sitagliptin 100 mg (dosed once daily with the morning dose of GSK1292263). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351068|NCT01119846|E12|Reported Event|Part C: Placebo Orally|Participants were randomized to 14 days of dosing with matching placebo (administered BID). In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351069|NCT01119846|E11|Reported Event|Part C: GSK1292263 600 mg Once Daily Orally|Participants were randomized to 14 days of dosing GSK1292263 600 mg once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351070|NCT01119846|E10|Reported Event|Part C: GSK1292263 300 mg BID Orally|Participants were randomized to 14 days of dosing GSK1292263 300 mg BID. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351071|NCT01119846|E9|Reported Event|Part C: GSK1292263 150 mg BID Orally|Participants were randomized to 14 days of dosing with GSK1292263 150 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351072|NCT01119846|E8|Reported Event|Part C: GSK1292263 50 mg BID Orally|Participants were randomized to 14 days of dosing with GSK1292263 50 mg BID once daily. In this part (Cohort 3 and Cohort 4), if Cohort 3 was dosed once daily, participants in Cohort 4 were enrolled to investigate the safety, tolerability, PK and PD of GSK1292263 when dosed in a BID regimen and vice versa. For once daily dosing, study drug was administered immediately after breakfast. For BID dosing, study drug was administered immediately after breakfast and immediately after the evening meal, but prior to the 10 hour PK sample.
351073|NCT01119846|E7|Reported Event|Part B: GSK1292263 800 mg Fed Condition Orally|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fed condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 min after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
351074|NCT01119846|E6|Reported Event|Part B: GSK1292263 800 mg Fasted Condition Orally|In this part (Cohort 2), eligible T2DM participants on mono-therapy or sub-maximal anti-diabetic medications washed off these medications for 1 week and received a single dose of GSK1292263 800 mg orally in fasted condition. Before participants in Part B were dosed, the safety and tolerability of GSK1292263 800 mg administered in the fasted state to 9 participants in Part A was reviewed to ensure that it was safe to proceed. In Part B, study drug was administered 30 min after breakfast and lunch and dinner was approximately 4 and 10 hours after dosing.
351075|NCT01119846|E5|Reported Event|Part A: Sitagliptin 100 mg Orally|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive sitagliptin 100 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351076|NCT01119846|E4|Reported Event|Part A: GSK1292263 800 mg Orally|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 800 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351077|NCT01119846|E3|Reported Event|Part A: GSK1292263 150 mg Orally|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 150 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351078|NCT01119846|E2|Reported Event|Part A: GSK1292263 25 mg Orally|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive GSK1292263 25 mg orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351079|NCT01119846|E1|Reported Event|Part A: Placebo|In this part (Cohort 1), drug naïve T2DM participants were randomized to receive matching placebo orally in fasted condition. These doses were administered to the participants in an ascending sequence irrespective of the randomization order for placebo and sitagliptin. In Part A, study drug was administered 2 hours before the OGTT.
351080|NCT01119794|B1|Baseline|Ofatumumab IV,|"Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22,~Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression"
351081|NCT01119794|P1|Participant Flow|Ofatumumab IV,|"Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22,~Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression"
351082|NCT01119794|O1|Outcome|Ofatumumab IV,|"Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22,~Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression"
351083|NCT01119794|E1|Reported Event|Ofatumumab IV,|"Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22,~Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression"
351084|NCT01119768|B3|Baseline|Total|Total of all reporting groups
351085|NCT01119768|B2|Baseline|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
351086|NCT01119768|B1|Baseline|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
351087|NCT01119768|P2|Participant Flow|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
351088|NCT01119768|P1|Participant Flow|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
351089|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
351090|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
351091|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
351092|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
351093|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
351094|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
351095|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
351096|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
351097|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
351098|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
351099|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
351100|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
351101|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
351102|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
351103|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
351104|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
351105|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
351106|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
351121|NCT01119716|P1|Participant Flow|All Enrolled Participants|Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
351122|NCT01119716|O3|Outcome|Total|All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
351123|NCT01119716|O2|Outcome|Female|Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
351124|NCT01119716|O1|Outcome|Male|Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
351125|NCT01119716|O3|Outcome|Total|All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
351126|NCT01119716|O2|Outcome|Female|Female participants with documented atrial fibrillation in the hospital setting for whom an electrical or pharmacological cardioversion was perfomed
351127|NCT01119716|O1|Outcome|Male|Male participants with documented atrial fibrillation in the hospital setting for whom an electrical or pharmacological cardioversion was perfomed
351128|NCT01119716|O3|Outcome|Total|All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
351129|NCT01119716|O2|Outcome|Female|Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
351130|NCT01119716|O1|Outcome|Male|Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
351131|NCT01119716|O3|Outcome|Total|All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
351132|NCT01119716|O2|Outcome|Female|Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
351133|NCT01119716|O1|Outcome|Male|Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
351134|NCT01119716|O3|Outcome|Total|All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
351135|NCT01119716|O2|Outcome|Female|Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
351136|NCT01119716|O1|Outcome|Male|Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
351137|NCT01119716|O3|Outcome|Total|All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
351138|NCT01119716|O2|Outcome|Female|Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
351139|NCT01119716|O1|Outcome|Male|Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
351140|NCT01119716|E1|Reported Event|All Enrolled Participants|Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
351141|NCT01119703|B3|Baseline|Total|Total of all reporting groups
351142|NCT01119703|B2|Baseline|Elderly Participants|Aged 65 years and older
351143|NCT01119703|B1|Baseline|Younger Participants|Aged 25 to 40 years old
351144|NCT01119703|P2|Participant Flow|Elderly Participants|Participants 65 years old and older.
351145|NCT01119703|P1|Participant Flow|Younger Participants|Participants 25 to 40 years of age.
351146|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
351147|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
351148|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
351149|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
351150|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
351151|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
351152|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
351153|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
351154|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older.
351155|NCT01119703|E1|Reported Event|All Participants|Participants who received at least one dose of each vaccine
351156|NCT01119625|B3|Baseline|Total|Total of all reporting groups
351157|NCT01119625|B2|Baseline|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351158|NCT01119625|B1|Baseline|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351159|NCT01119625|P2|Participant Flow|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351160|NCT01119625|P1|Participant Flow|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351161|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351162|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351163|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351164|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351165|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351166|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351167|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351168|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351169|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351170|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351171|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351172|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351173|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351174|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351175|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351176|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351177|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351178|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351179|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351180|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351181|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351182|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351183|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351184|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351185|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351186|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351187|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351188|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351189|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351190|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351191|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351192|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351193|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351194|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351195|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351196|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351197|NCT01119625|E2|Reported Event|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351198|NCT01119625|E1|Reported Event|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
351200|NCT01119443|B2|Baseline|Treatment Sequence B|0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fed -> 0.375 mg x 4 tablets q.d. fasted -> 1.5 mg x 1 tablet q.d. fasted
351201|NCT01119443|B1|Baseline|Treatment Sequence A|1.5 mg x 1 tablet q.d. fed -> 0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fasted -> 0.375 mg x 4 tablets q.d. fasted
351202|NCT01119443|P2|Participant Flow|Treatment Sequence B|0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fed -> 0.375 mg x 4 tablets q.d. fasted -> 1.5 mg x 1 tablet q.d. fasted
351203|NCT01119443|P1|Participant Flow|Treatment Sequence A|1.5 mg x 1 tablet once daily (q.d.) fed -> 0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fasted -> 0.375 mg x 4 tablets q.d. fasted
351204|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
351205|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
351206|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
351207|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
351208|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
351209|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
351210|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
351211|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
351212|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
351213|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
351214|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
351215|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
351216|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
351217|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
351218|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
351219|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
351220|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
351221|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
351222|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
351223|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
351224|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
351225|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
351226|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
351227|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
351228|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
351229|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
351230|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
351231|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
351232|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
351233|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
351234|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
351235|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
351236|NCT01119443|E3|Reported Event|1.5 mg q.d. Fast|1.5 mg x 1 tablet q.d. or 0.375 mg x 4 tablets q.d. in fast condition (10 days in crossover)
351237|NCT01119443|E2|Reported Event|1.5 mg q.d. Fed|1.5 mg x 1 tablet q.d. or 0.375 mg x 4 tablets q.d. in fed condition (10days in crossover)
351238|NCT01119443|E1|Reported Event|Up-titration|Up-titration to 0.75mg (10 days)
351239|NCT01119287|B7|Baseline|Total|Total of all reporting groups
351240|NCT01119287|B6|Baseline|Tears Naturale II/Cat Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
351241|NCT01119287|B5|Baseline|Patanol/Cat Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
351242|NCT01119287|B4|Baseline|Maxidex/Cat Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
351243|NCT01119287|B3|Baseline|Tears Naturale II/Ragweed Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
351244|NCT01119287|B2|Baseline|Patanol/Ragweed Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
351245|NCT01119287|B1|Baseline|Maxidex/Ragweed Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
351246|NCT01119287|P6|Participant Flow|Tears Naturale II/Cat Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
351247|NCT01119287|P5|Participant Flow|Patanol/Cat Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
351248|NCT01119287|P4|Participant Flow|Maxidex/Cat Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
351249|NCT01119287|P3|Participant Flow|Tears Naturale II/Ragweed Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
351250|NCT01119287|P2|Participant Flow|Patanol/Ragweed Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
351251|NCT01119287|P1|Participant Flow|Maxidex/Ragweed Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
351252|NCT01119287|O4|Outcome|Tears Naturale II/Cat Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
351253|NCT01119287|O3|Outcome|Patanol/Cat Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
351254|NCT01119287|O2|Outcome|Tears Naturale II/Ragweed Allergic|Inactive ingredients, used as placebo, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
351255|NCT01119287|O1|Outcome|Patanol/Ragweed Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
351256|NCT01119287|O4|Outcome|Tears Naturale II/Cat Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
351257|NCT01119287|O3|Outcome|Maxidex/Cat Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
351258|NCT01119287|O2|Outcome|Tears Naturale II/Ragweed Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
351259|NCT01119287|O1|Outcome|Maxidex/Ragweed Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
351260|NCT01119287|E3|Reported Event|Tears Naturale II|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
351261|NCT01119287|E2|Reported Event|Patanol|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
351262|NCT01119287|E1|Reported Event|Maxidex|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
351263|NCT01119222|B1|Baseline|Entire Study Population|Includes all participants who initiated in any treatment sequence
351264|NCT01119222|P4|Participant Flow|Diphenhydramine, Placebo, Gabapentin, Morphine|Diphenhydramine 50 mg tablet first, then placebo (capsules, tablet and intravenous (IV), then gabapentin 1200 mg capsule, then morphine 10 mg IV.
351265|NCT01119222|P3|Participant Flow|Gabapentin, Diphenhydramine, Morphine, Placebo|Gabapentin 1200 mg capsule first, then diphenhydramine 50 mg tablet, then morphine 10 mg intravenous (IV), then placebo (capsules, tablet and IV).
351266|NCT01119222|P2|Participant Flow|Morphine, Gabapentin, Placebo, Diphenhydramine|Morphine 10 mg intravenous (IV) first, then gabapentin 1200 mg capsule, placebo (capsules, tablet and IV), then diphenhydramine 50 mg tablet.
351267|NCT01119222|P1|Participant Flow|Placebo, Morphine, Diphenhydramine, Gabapentin|Placebo (capsules, tablet and intravenous (IV) first, then morphine 10 mg IV, then diphenhydramine 50 mg tablet, then gabapentin 1200 mg capsule.
351268|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
351269|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
351270|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
351271|NCT01119222|O1|Outcome|Gabapentin|Gabapentin single oral 1200 mg dose
351272|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
351273|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
351274|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
351275|NCT01119222|O1|Outcome|Gabapentin|Gabapentin single oral 1200 mg dose
351276|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
351277|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
351278|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
351279|NCT01119222|O1|Outcome|Gabapentin|Gabapentin 1200 mg
351280|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
351281|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
351282|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
351283|NCT01119222|O1|Outcome|Gabapentin|Gabapentin single oral 1200 mg dose
351284|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
351285|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
351286|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
351287|NCT01119222|O1|Outcome|Gabapentin|Gabapentin single oral 1200 mg dose
351288|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
351289|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
351297|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
351298|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
351299|NCT01119222|O1|Outcome|Gabapentin|Gabapentin single oral 1200 mg dose
351300|NCT01119222|E4|Reported Event|Placebo|Oral and IV doses to match active treatments
351301|NCT01119222|E3|Reported Event|Diphenhydramine|Diphenhydramine single oral 50 mg dose
351302|NCT01119222|E2|Reported Event|Morphine|Morphine single IV 10 mg dose
351303|NCT01119222|E1|Reported Event|Gabapentin|Gabapentin single oral 1200 mg dose
351304|NCT01119131|B4|Baseline|Total|Total of all reporting groups
351305|NCT01119131|B3|Baseline|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
351306|NCT01119131|B2|Baseline|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
351307|NCT01119131|B1|Baseline|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
351308|NCT01119131|P3|Participant Flow|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
351309|NCT01119131|P2|Participant Flow|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
351310|NCT01119131|P1|Participant Flow|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
351311|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
351312|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
351313|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
351314|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
351315|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
351316|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
351317|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
351318|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
351319|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
351320|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
351321|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
351322|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
351323|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
351324|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
351325|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
351326|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
351327|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
351328|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
351329|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
351330|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
351331|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
351332|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
351333|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
351334|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
351335|NCT01119131|E3|Reported Event|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
351336|NCT01119131|E2|Reported Event|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
351337|NCT01119131|E1|Reported Event|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
351338|NCT01119118|B1|Baseline|ZD4054|ZD4054 + multimodal PET/MRI imaging
351339|NCT01119118|P1|Participant Flow|ZD4054|ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
351340|NCT01119118|O1|Outcome|ZD4054|ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
351341|NCT01119118|O1|Outcome|ZD4054|ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
351342|NCT01119118|O1|Outcome|ZD4054|ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
351343|NCT01119118|O1|Outcome|ZD4054|ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
351344|NCT01119118|O1|Outcome|ZD4054|ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
351345|NCT01119118|E1|Reported Event|ZD4054|ZD4054 + multimodal PET/MRI imaging
351346|NCT01119040|B1|Baseline|Peg Rescue|Peg Rescue with NOTES in lieu of traditional surgical methods for dislodged PEG tubes.
351347|NCT01119040|P1|Participant Flow|"NOTES PEG Rescue"|Natural Orifice Translumenal Endoscopic Surgery (NOTES) procedures involve transmural passage of flexible endoscopes introduced via a natural orifice whereby permitting access to the peritoneal cavity while avoiding skin incisions.
351348|NCT01119040|O1|Outcome|NOTES PEG Rescue|Natural Orifice Translumenal Endoscopic Surgery (NOTES) procedures involve transmural passage of flexible endoscopes introduced via a natural orifice whereby permitting access to the peritoneal cavity while avoiding skin incisions.
351349|NCT01119040|E1|Reported Event|NOTES PEG Rescue|Peg Rescue with NOTES in lieu of traditional surgical methods for dislodged PEG tubes.
351350|NCT01119001|B1|Baseline|P300 Brain Computer Interface for People With ALS|P300 Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.
351351|NCT01119001|P1|Participant Flow|P300 Brain Computer Interface for People With ALS|P300 Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.
351352|NCT01119001|O3|Outcome|Assistive Technology Enironment|Accuracy typing for three sessions with the BCI acting as a keyboard for a Dynawrite communication system.
351353|NCT01119001|O2|Outcome|Computer Environment|Accuracy typing for three sessions with the BCI acting as a keyboard for a laptop computer.
351354|NCT01119001|O1|Outcome|Brain-computer Interface (BCI) Environment|Accuracy typing for three sessions with the BCI acting as a stand-alone device.
351355|NCT01119001|E1|Reported Event|P300 Brain Computer Interface for People With ALS|P300 Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.
351356|NCT01118988|B4|Baseline|Total|Total of all reporting groups
351357|NCT01118988|B3|Baseline|Mentors|"Subjects recruited to the Mentor arm of the study are UCLA Pediatric Pain Program patients between the ages of 14 and 18. These mentors are identified by the Principal Investigator as children who have not necessarily eliminated pain, but have learned how to cope with pain and maintain appropriate functioning in daily life. Mentors undergo an in depth training from doctoral level psychologists who are members of the research team. Mentors present pain coping information developed by the research team, provide support, and encourage mentees to attend pain management therapies. They are also monitored by doctoral level psychologists throughout the duration of the study to ensure safety and appropriate contact with mentees via telephone."
351358|NCT01118988|B2|Baseline|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
351359|NCT01118988|B1|Baseline|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
351360|NCT01118988|P3|Participant Flow|Mentors|"Subjects recruited to the Mentor arm of the study are UCLA Pediatric Pain Program patients between the ages of 14 and 18. These mentors are identified by the Principal Investigator as children who have not necessarily eliminated pain, but have learned how to cope with pain and maintain appropriate functioning in daily life. Mentors undergo an in depth training from doctoral level psychologists who are members of the research team. Mentors present pain coping information developed by the research team, provide support, and encourage mentees to attend pain management therapies. They are also monitored by doctoral level psychologists throughout the duration of the study to ensure safety and appropriate contact with mentees via telephone."
351361|NCT01118988|P2|Participant Flow|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
351362|NCT01118988|P1|Participant Flow|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
351363|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
351404|NCT01118962|O1|Outcome|Lacosamide|"Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).~Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses."
351364|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
351365|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
351366|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
351367|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
351368|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
351369|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
351370|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
351371|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
351372|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
351373|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
351374|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
351375|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
351376|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
351377|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
351378|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
351379|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
351380|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
351381|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
351405|NCT01118962|E1|Reported Event|Lacosamide|"Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).~Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses."
351382|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
351383|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
351384|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
351385|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
351386|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
351387|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
351388|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
351389|NCT01118988|E3|Reported Event|Mentors|"Subjects recruited to the Mentor arm of the study are UCLA Pediatric Pain Program patients between the ages of 14 and 18. These mentors are identified by the Principal Investigator as children who have not necessarily eliminated pain, but have learned how to cope with pain and maintain appropriate functioning in daily life. Mentors undergo an in depth training from doctoral level psychologists who are members of the research team. Mentors present pain coping information developed by the research team, provide support, and encourage mentees to attend pain management therapies. They are also monitored by doctoral level psychologists throughout the duration of the study to ensure safety and appropriate contact with mentees via telephone."
351390|NCT01118988|E2|Reported Event|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
351391|NCT01118988|E1|Reported Event|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
351392|NCT01118975|B3|Baseline|Total|Total of all reporting groups
351393|NCT01118975|B2|Baseline|Phase II - Vorinistat 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and vorinostat 400 mg 4 days on 3 days
351394|NCT01118975|B1|Baseline|Pilot Phase - Vornistat 200 to 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and escalating doses of vorinistat (200mg run-up, 300mg, and 400mg 4 days on 3 days off)
351395|NCT01118975|P2|Participant Flow|Phase II - Vorinistat 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and vorinostat 400 mg 4 days on 3 days
351396|NCT01118975|P1|Participant Flow|Pilot Phase - Vornistat 200 to 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and escalating doses of vorinistat (200mg run-up, 300mg, and 400mg 4 days on 3 days off)
351397|NCT01118975|O1|Outcome|Phase II - Vorinistat 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and vorinostat 400 mg 4 days on 3 days off
351398|NCT01118975|O1|Outcome|Pilot Phase|The pilot phase consisted of an escalating dose design. Three patients received lapatinib 1,250 mg daily plus 300 mg vorinistat 4 days on then 3 days off. This dose was tolerated so six more patients recieved lapatinib 1,250 mg daily plus 400 mg vorinistat 4 days on 3 days off.
351399|NCT01118975|E2|Reported Event|Phase II - Vorinistat 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and vorinostat 400 mg 4 days on 3 days
351400|NCT01118975|E1|Reported Event|Pilot Phase - Vornistat 200 to 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and escalating doses of vorinistat (200mg run-up, 300mg, and 400mg 4 days on 3 days off)
351401|NCT01118962|B1|Baseline|Lacosamide|"Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).~Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses."
351402|NCT01118962|P1|Participant Flow|Lacosamide|"Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).~Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses."
351403|NCT01118962|O1|Outcome|Lacosamide|"Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).~Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses."
352275|NCT01117051|E1|Reported Event|Placebo|once daily before breakfast for up to 12 weeks
351406|NCT01118949|B1|Baseline|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
351407|NCT01118949|P1|Participant Flow|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
351408|NCT01118949|O1|Outcome|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
351409|NCT01118949|O1|Outcome|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
351410|NCT01118949|O1|Outcome|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
351411|NCT01118949|O1|Outcome|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
351412|NCT01118949|O1|Outcome|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
351413|NCT01118949|O1|Outcome|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
351414|NCT01118949|E1|Reported Event|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
351415|NCT01118845|B1|Baseline|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
351416|NCT01118845|P1|Participant Flow|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
351417|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
351418|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
351419|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
351420|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
351421|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
351422|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
351423|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
351424|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
351425|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
351426|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
351427|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
351428|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
351429|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
351430|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
351431|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
351432|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
351433|NCT01118845|E1|Reported Event|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
351434|NCT01118780|B3|Baseline|Total|Total of all reporting groups
351435|NCT01118780|B2|Baseline|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
351436|NCT01118780|B1|Baseline|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
351437|NCT01118780|P2|Participant Flow|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
351438|NCT01118780|P1|Participant Flow|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
351439|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
351440|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
351441|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
351442|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
351443|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
351444|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
351445|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
352276|NCT01117012|B3|Baseline|Total|Total of all reporting groups
351446|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
351447|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
351448|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
351449|NCT01118780|O3|Outcome|Placebo|Participants, whose final dose during the treatment period was either placebo or duloxetine 30 mg, were administered a placebo capsule orally, once daily for 2 weeks, during the 2-week taper period.
351450|NCT01118780|O2|Outcome|Duloxetine 60 mg Then 30 mg|Participants, whose final dose during the treatment period was 90 mg or 120 mg duloxetine, were administered duloxetine 60 mg (two 30-mg duloxetine capsules) orally, once daily for 1 week followed by a 30-mg duloxetine capsule orally, once daily for 1 week, during the 2-week taper period.
351451|NCT01118780|O1|Outcome|Duloxetine 30 mg Then Placebo|Participants, whose final dose during the treatment period was duloxetine 60 mg, were administered a 30-mg duloxetine capsule orally, once daily for 1 week followed by a placebo capsule orally, once daily for 1 week, during the 2-week taper period.
351452|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
351453|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
351454|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
351455|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
351456|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
351457|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
351458|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
352934|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
351459|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
351460|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
351461|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
351462|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
351463|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
351464|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
351465|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
351466|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
351467|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
351468|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
351469|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
351470|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
351471|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
351472|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
351473|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
351474|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
351475|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
351476|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
351477|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
351478|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
351479|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
351480|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
351507|NCT01118663|O2|Outcome|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
351508|NCT01118663|O1|Outcome|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
351481|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
351482|NCT01118780|E2|Reported Event|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
351483|NCT01118780|E1|Reported Event|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
351484|NCT01118741|B3|Baseline|Total|Total of all reporting groups
351485|NCT01118741|B2|Baseline|Disulfiram High Dose 500mg Dose|After 9 subjects were enrolled in the low dose arm, the high dose was opened.
351486|NCT01118741|B1|Baseline|Disulfiram Low Dose 250mg Dose|First 9 subjects were assigned to the low dose arm
351487|NCT01118741|P2|Participant Flow|Disulfiram High Dose 500mg Dose|After accrual to the low dose was complete,ten subjects were assigned to the high dose (500mg) arm. These subjects took 500mg daily for 28 days per cycle.
351488|NCT01118741|P1|Participant Flow|Disulfiram Low Dose 250mg Dose|First 9 subjects were assigned to the low dose (250mg) arm. These subjects took 250mg daily for 28 days per cycle.
351489|NCT01118741|O2|Outcome|Disulfiram High Dose 500mg Dose|After accrual to the low dose was complete,ten subjects were assigned to the high dose (500mg) arm. These subjects took 500mg daily for 28 days per cycle.
351490|NCT01118741|O1|Outcome|Disulfiram Low Dose 250mg Dose|First 9 subjects were assigned to the low dose (250mg) arm. These subjects took 250mg daily for 28 days per cycle.
351491|NCT01118741|O2|Outcome|Disulfiram High Dose 500mg Dose|
351492|NCT01118741|O1|Outcome|Disulfiram Low Dose 250mg Dose|First 9 subjects were assigned to the low dose arm
351493|NCT01118741|E2|Reported Event|Disulfiram High Dose 500mg Dose|After 9 subjects were enrolled in the low dose arm, the high dose was opened.
351494|NCT01118741|E1|Reported Event|Disulfiram Low Dose 250mg Dose|First 9 subjects were assigned to the low dose arm
351495|NCT01118728|B1|Baseline|Sarilumab|Sarilumab 150 mg SC injection every week (or every other week in case of safety issue) for 260 weeks, or until commercially available, or until discontinuation of the project, whichever came first.
351496|NCT01118728|P1|Participant Flow|Sarilumab|Sarilumab 150 mg subcutaneous (SC) injection every week (or every other week in case of safety issue) for 260 weeks, or until commercially available, or until discontinuation of the project, whichever came first.
351497|NCT01118728|O1|Outcome|Sarilumab|Sarilumab 150 mg SC injection every week (or every other week in case of safety issue) for 260 weeks, or until commercially available, or until discontinuation of the project, whichever came first.
351498|NCT01118728|O1|Outcome|Sarilumab|Sarilumab 150 mg SC injection every week (or every other week in case of safety issue) for 260 weeks, or until commercially available, or until discontinuation of the project, whichever came first.
351499|NCT01118728|E1|Reported Event|Sarilumab|Sarilumab 150 mg SC injection every week (or every other week in case of safety issue) for 260 weeks, or until commercially available, or until discontinuation of the project, whichever came first.
351500|NCT01118663|B3|Baseline|Total|Total of all reporting groups
351501|NCT01118663|B2|Baseline|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
351502|NCT01118663|B1|Baseline|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
351503|NCT01118663|P2|Participant Flow|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
351504|NCT01118663|P1|Participant Flow|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
351505|NCT01118663|O2|Outcome|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
351506|NCT01118663|O1|Outcome|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
351582|NCT01118325|O2|Outcome|AZD6140 45 mg bd in Non-Japanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
351509|NCT01118663|O2|Outcome|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
351510|NCT01118663|O1|Outcome|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
351511|NCT01118663|O2|Outcome|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
351512|NCT01118663|O1|Outcome|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
351513|NCT01118663|O2|Outcome|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
351514|NCT01118663|O1|Outcome|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
351515|NCT01118663|E2|Reported Event|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
351516|NCT01118663|E1|Reported Event|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
351517|NCT01118624|B1|Baseline|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
351518|NCT01118624|P1|Participant Flow|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
351519|NCT01118624|O1|Outcome|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
351520|NCT01118624|O1|Outcome|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
351521|NCT01118624|O1|Outcome|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
351522|NCT01118624|O1|Outcome|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
351523|NCT01118624|E1|Reported Event|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
351524|NCT01118455|B3|Baseline|Total|Total of all reporting groups
351525|NCT01118455|B2|Baseline|Anti-Epileptic Drug (AED) - ITT Population|"This arm will supply a comparison between VNS and new AEDs which is necessary to determine an overall treatment regimen for the 30% to 40% of patients who fail to respond to 2 AEDs.~The intent-to-treat (ITT) population, defined as all subjects in VNS Therapy arm implanted with the VNS Therapy System (and the device had been turned on), and the Non-VNS arm, defined as all subjects who took at least 1 dose of study AED."
351526|NCT01118455|B1|Baseline|Vagus Nerve Stimulation (VNS) Therapy - ITT Population|"Vagus Nerve Stimulation (VNS) Therapy is delivered by an implantable device similar to a pacemaker that sends mild stimulation to the left vagus nerve to help improve seizure control.~The intent-to-treat (ITT) population, defined as all subjects in VNS Therapy arm implanted with the VNS Therapy System (and the device had been turned on), and the Non-VNS arm, defined as all subjects who took at least 1 dose of study AED."
351527|NCT01118455|P2|Participant Flow|Anti-Epileptic Drug (AED) - ITT Population|Anti-epileptic drug therapy
351528|NCT01118455|P1|Participant Flow|Vagus Nerve Stimulation (VNS) - ITT Population|Vagus Nerve Stimulation (VNS) Therapy
351529|NCT01118455|O2|Outcome|Anti-Epileptic Drug (AED)|Patients who were either treated with >5 AEDs or treated with 2-5 AEDs prior to study entry and were randomized to AED Group.
351530|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS)|Patients who were either treated with >5 AEDs or treated with 2-5 AEDs prior to study entry and were randomized to VNS Therapy.
351531|NCT01118455|O2|Outcome|Anti-Epileptic Drug (AED)|Patients who were either treated with >5 AEDs or treated with 2-5 AEDs prior to study entry and were randomized to AED Group.
351532|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS)|Patients who were either treated with >5 AEDs or treated with 2-5 AEDs prior to study entry and were randomized to VNS Therapy.
351533|NCT01118455|O4|Outcome|Anti-Epileptic Drug (AED) Non-Early|Patients who were treated with >5 AEDs prior to study entry who were randomized to AED Group.
351534|NCT01118455|O3|Outcome|Anti-Epileptic Drug (AED) Early|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
351535|NCT01118455|O2|Outcome|Vagus Nerve Stimulation (VNS) Non-Early|Patients who were treated with >5 AEDs prior to study entry who were randomized to VNS Therapy.
351536|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS) Early|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
351537|NCT01118455|O4|Outcome|Anti-Epileptic Drug (AED) - Non-Early Group|Patients who were treated with >5 AEDs prior to study entry who were randomized to AED Group.
351538|NCT01118455|O3|Outcome|Anti-Epileptic Drug (AED) - Early Group|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
351539|NCT01118455|O2|Outcome|Vagus Nerve Stimulation (VNS) - Non-Early Group|Patients who were treated with >5 AEDs prior to study entry who were randomized to VNS Therapy.
351540|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS) - Early Group|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
351541|NCT01118455|O4|Outcome|Anti-Epileptic Drug (AED) - Non-Early Group|Patients who were treated with >5 AEDs prior to study entry who were randomized to AED Group.
351542|NCT01118455|O3|Outcome|Anti-Epileptic Drug (AED) - Early Group|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
351543|NCT01118455|O2|Outcome|Vagus Nerve Stimulation (VNS) - Non-Early Group|Patients who were treated with >5 AEDs prior to study entry who were randomized to VNS Therapy.
352935|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
351544|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS) - Early Group|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
351545|NCT01118455|O4|Outcome|Anti-Epileptic Drug (AED) Non-Early|Patients who were treated with >5 AEDs prior to study entry who were randomized to AED Group.
351546|NCT01118455|O3|Outcome|Anti-Epileptic Drug (AED) Early|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
351547|NCT01118455|O2|Outcome|Vagus Nerve Stimulation (VNS) Non-Early|Patients who were treated with >5 AEDs prior to study entry who were randomized to VNS Therapy.
351548|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS) Early|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
351549|NCT01118455|O4|Outcome|Anti-Epileptic Drug (AED) - Non-Early Group|Patients who were treated with >5 AEDs prior to study entry who were randomized to AED Group.
351550|NCT01118455|O3|Outcome|Anti-Epileptic Drug (AED) - Early Group|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
351551|NCT01118455|O2|Outcome|Vagus Nerve Stimulation (VNS) - Non-Early Group|Patients who were treated with >5 AEDs prior to study entry who were randomized to VNS Therapy.
351552|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS) - Early Group|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
351553|NCT01118455|E2|Reported Event|Anti-Epileptic Drug (AED) - Safety Population|"This arm will supply a comparison between VNS and new AEDs which is necessary to determine an overall treatment regimen for the 30% to 40% of patients who fail to respond to 2 AEDs.~All subjects were considered evaluable for tolerability and safety after initiation of adjunctive AED treatment."
351554|NCT01118455|E1|Reported Event|Vagus Nerve Stimulation (VNS) Therapy - Safety Population|"Vagus Nerve Stimulation (VNS) Therapy is delivered by an implantable device similar to a pacemaker that sends mild stimulation to the left vagus nerve to help improve seizure control.~All subjects were considered evaluable for tolerability and safety after implantation of the VNS Therapy System.~NOTE: Number of participants analyzed in VNS safety population includes one patient explanted that did not receive stimulation and was therefore excluded from ITT population."
351555|NCT01118377|B1|Baseline|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
351556|NCT01118377|P1|Participant Flow|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
351557|NCT01118377|O1|Outcome|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
351558|NCT01118377|O1|Outcome|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
351559|NCT01118377|O1|Outcome|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
351560|NCT01118377|E1|Reported Event|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
351561|NCT01118325|B4|Baseline|Total|Total of all reporting groups
351562|NCT01118325|B3|Baseline|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
351563|NCT01118325|B2|Baseline|AZD6140 90 mg bd|AZD6140 90 mg twice daily
351564|NCT01118325|B1|Baseline|AZD6140 45 mg bd|AZD6140 45 mg twice daily
351565|NCT01118325|P3|Participant Flow|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
351566|NCT01118325|P2|Participant Flow|AZD6140 90 mg bd|AZD6140 90 mg twice daily
351567|NCT01118325|P1|Participant Flow|AZD6140 45 mg bd|AZD6140 45 mg twice daily
351568|NCT01118325|O4|Outcome|AZD6140 90 mg bd in Non-Japanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
351569|NCT01118325|O3|Outcome|AZD6140 90 mg bd in Japanese Patients|AZD6140 90 mg twice daily in Japanese Patients
351570|NCT01118325|O2|Outcome|AZD6140 45 mg bd in Non-Japanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
351571|NCT01118325|O1|Outcome|AZD6140 45 mg bd in Japanese Patients|AZD6140 45 mg twice daily in Japanese Patients
351572|NCT01118325|O4|Outcome|AZD6140 90 mg bd in Non-Japanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
351573|NCT01118325|O3|Outcome|AZD6140 90 mg bd in Japanese Patients|AZD6140 90 mg twice daily in Japanese patients
351574|NCT01118325|O2|Outcome|AZD6140 45 mg bd in Non-Japanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
351575|NCT01118325|O1|Outcome|AZD6140 45 mg bd in Japanese Patients|AZD6140 45 mg twice daily in Japanese patients
351576|NCT01118325|O4|Outcome|AZD6140 90 mg bd in Non-Jpanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
351577|NCT01118325|O3|Outcome|AZD6140 90 mg bd in Japanese Patients|AZD6140 90 mg twice daily in Japanese patients
351578|NCT01118325|O2|Outcome|AZD6140 45mg bd in Non-Jpanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
351579|NCT01118325|O1|Outcome|AZD6140 45 mg bd in Japanese Patients|AZD6140 45 mg twice daily in Japanese patients
351580|NCT01118325|O4|Outcome|AZD6140 90 mg bd in Non-Japanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
351581|NCT01118325|O3|Outcome|AZD6140 90 mg bd in Japanese Patients|AZD6140 90 mg twice daily in Japanese patients
351583|NCT01118325|O1|Outcome|AZD6140 45 mg bd in Japanese Patients|AZD6140 45 mg twice daily in Japanese patients
351584|NCT01118325|O4|Outcome|AZD6140 90 mg bd in Non-Japanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
351585|NCT01118325|O3|Outcome|AZD6140 90 mg bd in Japanese Patients|AZD6140 90 mg twice daily in Japanese patients
351586|NCT01118325|O2|Outcome|AZD6140 45 mg bd in Non-Japanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
351587|NCT01118325|O1|Outcome|AZD6140 45 mg bd in Japanese Patients|AZD6140 45 mg twice daily in Japanese patients
351588|NCT01118325|O4|Outcome|AZD6140 90 mg bd in Non-Japanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
351589|NCT01118325|O3|Outcome|AZD6140 90 mg bd in Japanese Patients|AZD6140 90 mg twice daily in Japanese patients
351590|NCT01118325|O2|Outcome|AZD6140 45 mg bd in Non-Japanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
351591|NCT01118325|O1|Outcome|AZD6140 45 mg bd in Japanese Patients|AZD6140 45 mg twice daily in Japanese patients
351592|NCT01118325|O3|Outcome|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
351593|NCT01118325|O2|Outcome|AZD6140 90 mg bd|AZD6140 90 mg twice daily
351594|NCT01118325|O1|Outcome|AZD6140 45 mg bd|AZD6140 45 mg twice daily
351595|NCT01118325|O3|Outcome|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
351596|NCT01118325|O2|Outcome|AZD6140 90 mg bd|AZD6140 90 mg twice daily
351597|NCT01118325|O1|Outcome|Arm 1 - AZD6140 45 mg bd|AZD6140 45 mg twice daily
351598|NCT01118325|O3|Outcome|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
351599|NCT01118325|O2|Outcome|AZD6140 90 mg bd|AZD6140 90 mg twice daily
351600|NCT01118325|O1|Outcome|AZD6140 45 mg bd|AZD6140 45 mg twice daily
351601|NCT01118325|O3|Outcome|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
351602|NCT01118325|O2|Outcome|AZD6140 90 mg bd|AZD6140 90 mg twice daily in Japanese patients
351603|NCT01118325|O1|Outcome|AZD6140 45 mg bd|AZD6140 45 mg twice daily in Japanese patients
351604|NCT01118325|O3|Outcome|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
351605|NCT01118325|O2|Outcome|AZD6140 90 mg bd|AZD6140 90 mg twice daily in Japanese patients
351606|NCT01118325|O1|Outcome|AZD6140 45 mg bd|AZD6140 45 mg twice daily in Japanese patients
351607|NCT01118325|E3|Reported Event|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
351608|NCT01118325|E2|Reported Event|AZD6140 90 mg bd|AZD6140 90 mg twice daily
351609|NCT01118325|E1|Reported Event|AZD6140 45 mg bd|AZD6140 45 mg twice daily
351610|NCT01118312|B3|Baseline|Total|Total of all reporting groups
351611|NCT01118312|B2|Baseline|Placebo|"Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Placebo: Intranasal placebo spray"
351612|NCT01118312|B1|Baseline|Nasal Steroid|"Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months"
351613|NCT01118312|P2|Participant Flow|Placebo|"Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Placebo: Intranasal placebo spray"
351614|NCT01118312|P1|Participant Flow|Nasal Steroid|"Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months"
351615|NCT01118312|O2|Outcome|Placebo|"Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Placebo: Intranasal placebo spray"
351616|NCT01118312|O1|Outcome|Nasal Steroid|"Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months"
351617|NCT01118312|O2|Outcome|Placebo|"Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Placebo: Intranasal placebo spray"
351618|NCT01118312|O1|Outcome|Nasal Steroid|"Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months"
351619|NCT01118312|E2|Reported Event|Placebo|"Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Placebo: Intranasal placebo spray"
351620|NCT01118312|E1|Reported Event|Nasal Steroid|"Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months"
351621|NCT01118273|B7|Baseline|Total|Total of all reporting groups
351622|NCT01118273|B6|Baseline|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351623|NCT01118273|B5|Baseline|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351624|NCT01118273|B4|Baseline|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351625|NCT01118273|B3|Baseline|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
351626|NCT01118273|B2|Baseline|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351627|NCT01118273|B1|Baseline|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351628|NCT01118273|P6|Participant Flow|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351629|NCT01118273|P5|Participant Flow|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351630|NCT01118273|P4|Participant Flow|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
351631|NCT01118273|P3|Participant Flow|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351632|NCT01118273|P2|Participant Flow|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351633|NCT01118273|P1|Participant Flow|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351634|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351635|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351636|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
351637|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351638|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351639|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351640|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351641|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351642|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
351643|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351644|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351645|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351646|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351647|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351648|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
351649|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351650|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351651|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351652|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351653|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351654|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
351655|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351656|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351657|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351658|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351659|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351660|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
351661|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351662|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351663|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351664|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351665|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351666|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
351667|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351668|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351669|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351670|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351671|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351672|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
351673|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351674|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351675|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351676|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351677|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351678|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
351679|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351680|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351681|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351682|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351683|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351684|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
351685|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351686|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351687|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351688|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351689|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351690|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
351691|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351692|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351693|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351694|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351695|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351696|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
351697|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351698|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351699|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351700|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351701|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351702|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
352936|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
351703|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351704|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351705|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351706|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351707|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351708|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
351709|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351710|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351711|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351712|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351713|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351714|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
351715|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351716|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351717|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351718|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351719|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351720|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
351721|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351722|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351723|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351724|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351725|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351726|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
351727|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351728|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351729|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351730|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351731|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351732|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
351733|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351734|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351735|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351736|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351737|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351738|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
352937|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
351739|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351740|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351741|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351742|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351743|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351744|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
351745|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351746|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351747|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351748|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351749|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351750|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
351751|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351752|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351753|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351754|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351755|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351756|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
351757|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351758|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351759|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351760|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351761|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351762|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
351763|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351764|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351765|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351766|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351767|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351768|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
351769|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351770|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351771|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351772|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351773|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351774|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
352938|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
351775|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351776|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351777|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351778|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351779|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351780|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
351781|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351782|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351783|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351784|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351785|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351786|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
351787|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351788|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351789|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351790|NCT01118273|E6|Reported Event|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
351791|NCT01118273|E5|Reported Event|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
351792|NCT01118273|E4|Reported Event|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
351793|NCT01118273|E3|Reported Event|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
351794|NCT01118273|E2|Reported Event|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
351795|NCT01118273|E1|Reported Event|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
351796|NCT01118221|B3|Baseline|Total|Total of all reporting groups
351797|NCT01118221|B2|Baseline|Control|no structured exercise
351798|NCT01118221|B1|Baseline|Pulmonary Rehabilitation|"enroll in pulmonary rehabilitation program~pulmonary rehabilitation: structured exercise program"
351799|NCT01118221|P2|Participant Flow|Control|no structured exercise
351800|NCT01118221|P1|Participant Flow|Pulmonary Rehabilitation|"enroll in pulmonary rehabilitation program~pulmonary rehabilitation: structured exercise program"
351801|NCT01118221|O2|Outcome|Control Group|no structured exercise
351802|NCT01118221|O1|Outcome|Rehabilitation Group|"enroll in pulmonary rehabilitation program~pulmonary rehabilitation: structured exercise program"
351803|NCT01118221|O2|Outcome|After Exercise Testing|Plasma isoprostanes after exercise testing.
351804|NCT01118221|O1|Outcome|Before Exercise Testing|Plasma isoprostanes before exercise test.
351805|NCT01118221|O2|Outcome|Arm 2|no structured exercise
351806|NCT01118221|O1|Outcome|Arm 1|"enroll in pulmonary rehabilitation program~pulmonary rehabilitation: structured exercise program"
351807|NCT01118221|E2|Reported Event|Arm 2|no structured exercise
351808|NCT01118221|E1|Reported Event|Arm 1|"enroll in pulmonary rehabilitation program~pulmonary rehabilitation: structured exercise program"
351809|NCT01118143|B3|Baseline|Total|Total of all reporting groups
351810|NCT01118143|B2|Baseline|Ordinary Oral Health Instruction|Oral health instruction commonly used in general practice
351811|NCT01118143|B1|Baseline|Individualized Oral Health Instruction|Individualized oral health instruction adapted to the patients oral health literacy level
351812|NCT01118143|P2|Participant Flow|Control: Short Standard Information|Participants in the control group got short standard information after the clinical measurement, as usual in general dental clinical practice. E.g. If there was gingival bleeding, participants got a message that their gums were bleeding and that dental floss was recommended.
351813|NCT01118143|P1|Participant Flow|Experiment: Communication Adapted to Health Literacy Level|Participants in the experimental group got individualized communication regarding their oral health. The communication was adapted to the measured Health Literacy level of each participant. Health Literacy communication theory was utilized in order to adapt the communication to the participants Health literacy level. Two-way communication with use of models, illustrative pictures and teach-back method was emphasized. Up to 30 minutes was available for this intervention conversation.
351814|NCT01118143|O2|Outcome|Ordinary Oral Health Instruction|The effect of intervention is evaluated using measures of plaque index
352939|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
351815|NCT01118143|O1|Outcome|Individualized Oral Health Instruction|The effect of intervention is evaluated using measures of plaque index
351816|NCT01118143|O2|Outcome|Ordinary Oral Health Instruction|Oral health instruction commonly used in general practice
351817|NCT01118143|O1|Outcome|Individualized Oral Health Instruction|Individualized oral health instruction adapted to the patients oral health literacy level
351818|NCT01118143|E2|Reported Event|Control|The oral health instruction is according to standard clinical practice
351819|NCT01118143|E1|Reported Event|Individualized Oral Health Instruction|The oral health instruction is individualized according to the patients oral health literacy level
351820|NCT01118117|B3|Baseline|Total|Total of all reporting groups
351821|NCT01118117|B2|Baseline|Long Length (150mm) Misago™ Self-Expanding Stent System|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
351822|NCT01118117|B1|Baseline|Misago™ Self-Expanding Stent System|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
351823|NCT01118117|P2|Participant Flow|Long Length Stent Sub-Study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150 mm intravascular stent
351824|NCT01118117|P1|Participant Flow|Misago™ Self-Expanding Stent System|Subjects received treatment with the Misago™ Self-Expanding Stent
351825|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
351826|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
351827|NCT01118117|O2|Outcome|Long Length Stent Sub-Study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
351828|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
351829|NCT01118117|O2|Outcome|Long Length Stent Sub-Study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
351830|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
351831|NCT01118117|O2|Outcome|Long Length Stent Sub-Study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
351832|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
351833|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
351834|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
351835|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
351836|NCT01118117|O2|Outcome|Long Length Stent Sub-Study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
351837|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
351838|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
351839|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
351840|NCT01118117|E2|Reported Event|Long Length Stent Sub-study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150 mm intravascular stent
351841|NCT01118117|E1|Reported Event|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
351842|NCT01118091|B3|Baseline|Total|Total of all reporting groups
351843|NCT01118091|B2|Baseline|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.~CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
351844|NCT01118091|B1|Baseline|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.~Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
351845|NCT01118091|P2|Participant Flow|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.~CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
351846|NCT01118091|P1|Participant Flow|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.~Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
351847|NCT01118091|O2|Outcome|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.~CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
351848|NCT01118091|O1|Outcome|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.~Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
351849|NCT01118091|O2|Outcome|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.~CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
351850|NCT01118091|O1|Outcome|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.~Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
351851|NCT01118091|O2|Outcome|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.~CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
351852|NCT01118091|O1|Outcome|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.~Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
351853|NCT01118091|E2|Reported Event|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.~CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
351854|NCT01118091|E1|Reported Event|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.~Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
351855|NCT01118052|B1|Baseline|Treatment (EGEN-001)|"Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1: Given intraperitoneally"
351856|NCT01118052|P1|Participant Flow|Treatment (EGEN-001)|"Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1: Given intraperitoneally"
351857|NCT01118052|O1|Outcome|Treatment (EGEN-001)|"Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1: Given intraperitoneally"
351858|NCT01118052|O1|Outcome|Treatment (EGEN-001)|"Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1: Given intraperitoneally"
351859|NCT01118052|O6|Outcome|Grade 5 (CTCAE v 4.0)|Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
351860|NCT01118052|O5|Outcome|Grade 4 (CTCAE v 4.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
351861|NCT01118052|O4|Outcome|Grade 3 (CTCAE v 4.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
351862|NCT01118052|O3|Outcome|Grade 2 (CTCAE v 4.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
351863|NCT01118052|O2|Outcome|Grade 1 (CTCAE v 4.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
351864|NCT01118052|O1|Outcome|Grade 0|Number of patients who did not experience the specified AE.
351865|NCT01118052|O1|Outcome|Treatment (EGEN-001)|"Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1: Given intraperitoneally"
351866|NCT01118052|O1|Outcome|Treatment (EGEN-001)|"Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1: Given intraperitoneally"
352145|NCT01117428|P3|Participant Flow|Part C: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 9 mg/kg, weekly – i.v. infusions"
351867|NCT01118052|E1|Reported Event|Treatment (EGEN-001)|"Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1: Given intraperitoneally"
351868|NCT01118013|B1|Baseline|Treatment|"Participants will receive:~Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
351869|NCT01118013|P1|Participant Flow|Treatment|"Participants will receive:~Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
351870|NCT01118013|O1|Outcome|Treatment|"Participants will receive:~Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
351871|NCT01118013|O1|Outcome|Treatment|"Participants will receive:~Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
351872|NCT01118013|O1|Outcome|Treatment|"Participants will receive:~Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
351873|NCT01118013|O1|Outcome|Treatment|"Participants will receive:~Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
351874|NCT01118013|O1|Outcome|Treatment|"Participants will receive:~Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
351875|NCT01118013|E1|Reported Event|Treatment|"Participants will receive:~Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
351876|NCT01117987|B3|Baseline|Total|Total of all reporting groups
351877|NCT01117987|B2|Baseline|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
351878|NCT01117987|B1|Baseline|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
351879|NCT01117987|P2|Participant Flow|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
351880|NCT01117987|P1|Participant Flow|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
351881|NCT01117987|O2|Outcome|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
352550|NCT01116102|O6|Outcome|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
351882|NCT01117987|O1|Outcome|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
351883|NCT01117987|O2|Outcome|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
351884|NCT01117987|O1|Outcome|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
351885|NCT01117987|O2|Outcome|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
351886|NCT01117987|O1|Outcome|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
351887|NCT01117987|E2|Reported Event|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
351888|NCT01117987|E1|Reported Event|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
351889|NCT01117948|B3|Baseline|Total|Total of all reporting groups
351890|NCT01117948|B2|Baseline|Placebo|Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
351891|NCT01117948|B1|Baseline|Lornoxicam|Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
351892|NCT01117948|P2|Participant Flow|Placebo|Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
351893|NCT01117948|P1|Participant Flow|Lornoxicam|Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
351894|NCT01117948|O2|Outcome|Placebo|Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
351895|NCT01117948|O1|Outcome|Lornoxicam|Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
351896|NCT01117948|E2|Reported Event|Placebo|Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
351897|NCT01117948|E1|Reported Event|Lornoxicam|Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
351898|NCT01117870|B3|Baseline|Total|Total of all reporting groups
351899|NCT01117870|B2|Baseline|PRF Treatment|"PRF will be applied for 120 seconds at 42 degrees celsius.~Pulsed RadioFrequency: 120 seconds at 42 degrees celsius"
351900|NCT01117870|B1|Baseline|Placebo|"The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.~Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application."
351901|NCT01117870|P2|Participant Flow|PRF Treatment|"PRF will be applied for 120 seconds at 42 degrees celsius.~Pulsed RadioFrequency: 120 seconds at 42 degrees celsius"
351902|NCT01117870|P1|Participant Flow|Placebo|"The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.~Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application."
351903|NCT01117870|O2|Outcome|PRF Treatment|"PRF will be applied for 120 seconds at 42 degrees celsius.~Pulsed RadioFrequency: 120 seconds at 42 degrees celsius"
351904|NCT01117870|O1|Outcome|Placebo|"The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.~Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application."
351905|NCT01117870|O2|Outcome|PRF Treatment|"PRF will be applied for 120 seconds at 42 degrees celsius.~Pulsed RadioFrequency: 120 seconds at 42 degrees celsius"
351906|NCT01117870|O1|Outcome|Placebo|"The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.~Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application."
351907|NCT01117870|O2|Outcome|PRF Treatment|"PRF will be applied for 120 seconds at 42 degrees celsius.~Pulsed RadioFrequency: 120 seconds at 42 degrees celsius"
351908|NCT01117870|O1|Outcome|Placebo|"The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.~Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application."
351909|NCT01117870|O2|Outcome|PRF Treatment|"PRF will be applied for 120 seconds at 42 degrees celsius.~Pulsed RadioFrequency: 120 seconds at 42 degrees celsius~The study of the efficacy of cervical PRF-DRG showed significant results favoring PRF-DRG for a 20% pain reduction in VAS score. It has been noted that a 30% reduction in pain appears to reflect at least a moderate clinically important difference, and this needs to be considered in clinical trials."
351910|NCT01117870|O1|Outcome|Placebo|"The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.~Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application.~The study of the efficacy of cervical PRF-DRG showed significant results favoring PRF-DRG for a 20% pain reduction in VAS score. It has been noted that a 30% reduction in pain appears to reflect at least a moderate clinically important difference, and this needs to be considered in clinical trials."
351911|NCT01117870|O1|Outcome|Lost to Follow-up Patients|Patients who were lost to follow-up at 3 months
351912|NCT01117870|O1|Outcome|Eligible Patients|Patients meeting eligibility criteria
351913|NCT01117870|E2|Reported Event|PRF Treatment|"PRF will be applied for 120 seconds at 42 degrees celsius.~Pulsed RadioFrequency: 120 seconds at 42 degrees celsius"
351914|NCT01117870|E1|Reported Event|Placebo|"The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.~Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application."
351915|NCT01117857|B1|Baseline|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
351916|NCT01117857|P1|Participant Flow|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
351917|NCT01117857|O1|Outcome|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
351918|NCT01117857|O1|Outcome|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
351919|NCT01117857|O1|Outcome|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
351920|NCT01117857|O1|Outcome|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
351921|NCT01117857|O1|Outcome|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
351922|NCT01117857|E1|Reported Event|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
351923|NCT01117766|B1|Baseline|All Participants|Includes all participants randomized to receive pregabalin first and placebo first.
351924|NCT01117766|P2|Participant Flow|Placebo Then Pregabalin|Participants took placebo to match the pregabalin doses BID during the first 4- week treatment period. Then after a 2-week washout period, participants were titrated up to 300 mg pregabalin BID for the first 2 weeks and then remained at 300 mg BID for the duration of the second 4-week treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
351925|NCT01117766|P1|Participant Flow|Pregabalin Then Placebo|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg twice daily (BID) for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later. Then after a 2-week washout period, participants took placebo to match the pregabalin doses BID during a 4-week treatment period.
351926|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
351927|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
351928|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
351929|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
351930|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
351931|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
351932|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
351933|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
351934|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
351935|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
351936|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
351937|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
351938|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
352223|NCT01117337|E1|Reported Event|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
351939|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
351940|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
351941|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
351942|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
351943|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
351944|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
351945|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
351946|NCT01117766|E2|Reported Event|Placebo|Participants took placebo to match the pregabalin doses BID.
351947|NCT01117766|E1|Reported Event|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
351948|NCT01117727|B1|Baseline|Pilot Testing|Brain Computer Interface Switch: Subjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 14-20 sessions.
351949|NCT01117727|P1|Participant Flow|Pilot Testing|Brain Computer Interface Switch: Subjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 14-20 sessions.
351950|NCT01117727|O2|Outcome|Pilot Testing With Scan Rate at 2 Stdev|Pilot testing with scan rate set at twice the standard deviation of the reaction time.
351951|NCT01117727|O1|Outcome|Pilot Testing, 0.65 Scan Rate|Pilot subject testing protocol with scan rate at 0.65 seconds per item.
351952|NCT01117727|E1|Reported Event|Pilot Testing|Brain Computer Interface Switch: Subjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 14-20 sessions.
351953|NCT01117623|B9|Baseline|Total|Total of all reporting groups
351954|NCT01117623|B8|Baseline|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351955|NCT01117623|B7|Baseline|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351956|NCT01117623|B6|Baseline|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351957|NCT01117623|B5|Baseline|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351958|NCT01117623|B4|Baseline|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351959|NCT01117623|B3|Baseline|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351960|NCT01117623|B2|Baseline|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351961|NCT01117623|B1|Baseline|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352146|NCT01117428|P2|Participant Flow|Part B: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-epidermal growth factor receptor (anti-EGFR) antibody refractory metastatic colorectal cancer (mCRC).~Sym004: 12 mg/kg, weekly – i.v. infusions"
352551|NCT01116102|O5|Outcome|25 ga Needle, Dose Flush, Single-step Rate Scheme|
351962|NCT01117623|P8|Participant Flow|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351963|NCT01117623|P7|Participant Flow|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351964|NCT01117623|P6|Participant Flow|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351965|NCT01117623|P5|Participant Flow|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 140 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351966|NCT01117623|P4|Participant Flow|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 120 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351967|NCT01117623|P3|Participant Flow|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351968|NCT01117623|P2|Participant Flow|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351969|NCT01117623|P1|Participant Flow|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral co-precipitate (CP) tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351970|NCT01117623|O2|Outcome|NSCLC Expansion Cohort, Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351971|NCT01117623|O1|Outcome|HCC Expansion Cohort, Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A or B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351972|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351973|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351974|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351975|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351976|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352147|NCT01117428|P1|Participant Flow|Part A: Dose Escalation|"Dose escalation in patients with refractory or recurrent advanced solid tumors.~Sym004: 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly – i.v. infusions"
352224|NCT01117311|B1|Baseline|Entire Study Population|Includes groups randomized to have the VNB off first and the VNB on first.
351977|NCT01117623|O2|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351978|NCT01117623|O1|Outcome|HCC Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A or B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351979|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351980|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351981|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351982|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351983|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351984|NCT01117623|O1|Outcome|Regorafenib, 20 mg, 40 mg, 100 mg, 120 mg, 140 mg|Participants in the dose-escalation cohort received a single 20 mg, 40 mg, 100 mg, 120 mg, 140 mg oral CP tablet of regorafenib respectively on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351985|NCT01117623|O1|Outcome|Regorafenib, 20 mg, 40 mg, 100 mg, 120 mg, 140 mg|Participants in the dose-escalation cohort received a single 20 mg, 40 mg, 100 mg, 120 mg, 140 mg oral CP tablet of regorafenib respectively on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351986|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351987|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351988|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351989|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351990|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351991|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352148|NCT01117428|O6|Outcome|Part F: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 9 mg/kg loading dose followed by 6 mg/kg, weekly – i.v. infusion"
352270|NCT01117051|O1|Outcome|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
351992|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351993|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351994|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351995|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351996|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351997|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351998|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
351999|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352000|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352001|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352002|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352003|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352004|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352005|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352006|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352149|NCT01117428|O5|Outcome|Part E: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 18 mg/kg, once every 2 weeks – i.v. infusions"
352271|NCT01117051|O1|Outcome|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
352007|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352008|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352009|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352010|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352011|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352012|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352013|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352014|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352015|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352016|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352017|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352018|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352019|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352020|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352021|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352150|NCT01117428|O4|Outcome|Part D: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 12 mg/kg, once every 2 weeks – i.v. infusions"
352151|NCT01117428|O3|Outcome|Part C: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 9 mg/kg, weekly – i.v. infusions"
352022|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352023|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352024|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352025|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352026|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352027|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352028|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352029|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352030|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352031|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352032|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352033|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352034|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352035|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352036|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352152|NCT01117428|O2|Outcome|Part B: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 12 mg/kg, weekly – i.v. infusions"
352272|NCT01117051|O2|Outcome|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
352940|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
352037|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352038|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352039|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352040|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352041|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352042|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352043|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352044|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352045|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352046|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352047|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352048|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352049|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352050|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352051|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352097|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352052|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352053|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352054|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352055|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352056|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352057|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352058|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352059|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352060|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352061|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352062|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352063|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352064|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352065|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352066|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352113|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352067|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352068|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352069|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352070|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352071|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352072|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352073|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352074|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352075|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352076|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352077|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352078|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352079|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352080|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352081|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352142|NCT01117428|P6|Participant Flow|Part F: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 9 mg/kg loading dose followed by 6 mg/kg, weekly – i.v. infusions"
352221|NCT01117337|O1|Outcome|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
352082|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352083|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352084|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352085|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352086|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352087|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352088|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352089|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352090|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352091|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352092|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352093|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352094|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352095|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352096|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352143|NCT01117428|P5|Participant Flow|Part E: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 18 mg/kg, once every 2 weeks – i.v. infusions"
352222|NCT01117337|E2|Reported Event|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
352098|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352099|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352100|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352101|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352102|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352103|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352104|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352105|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352106|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352107|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352108|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352109|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352110|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352111|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352112|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352144|NCT01117428|P4|Participant Flow|Part D: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 12 mg/kg, once every 2 weeks – i.v. infusions"
352273|NCT01117051|O1|Outcome|Placebo|once daily before breakfast for up to 12 weeks
352941|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
352114|NCT01117623|O1|Outcome|Regorafenib, 20 mg, 40 mg, 100 mg, 120 mg, 140 mg|Participants in the dose-escalation cohort received a single 20 mg, 40 mg, 100 mg, 120 mg, 140 mg oral CP tablet of regorafenib respectively on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352115|NCT01117623|E5|Reported Event|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 140 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352116|NCT01117623|E4|Reported Event|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 120 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352117|NCT01117623|E3|Reported Event|Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle. This arm includes the participants from the dose escalation cohort: Regorafenib 100 mg and the three Expansion Cohorts 'HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg', 'HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg', 'NSCLC Expansion Cohort: Regorafenib 100 mg'.
352118|NCT01117623|E2|Reported Event|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352119|NCT01117623|E1|Reported Event|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
352120|NCT01117480|B1|Baseline|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
352121|NCT01117480|P1|Participant Flow|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
352122|NCT01117480|O1|Outcome|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
352123|NCT01117480|O1|Outcome|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
352124|NCT01117480|O1|Outcome|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
352125|NCT01117480|E1|Reported Event|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
352126|NCT01117454|B3|Baseline|Total|Total of all reporting groups
352127|NCT01117454|B2|Baseline|Placebo Then Flecainide|"In this crossover study, half of the subjects will be randomized to placebo plus standard therapy first, then crossover to flecainide plus standard therapy.~flecainide: oral flecainide will be added to standard therapy with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml"
352128|NCT01117454|B1|Baseline|Flecainide Then Placebo|"In this crossover study, half of the subjects will be randomized to flecainide plus standard therapy first, then crossover to placebo plus standard therapy.~flecainide: oral flecainide will be added to standard therapy with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml"
352129|NCT01117454|P2|Participant Flow|Placebo Then Flecainide|"In this crossover study, half of the subjects will be randomized to placebo plus standard therapy first, then crossover to flecainide plus standard therapy.~flecainide: oral flecainide will be added to standard therapy with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml"
352130|NCT01117454|P1|Participant Flow|Flecainide Then Placebo|"In this crossover study, half of the subjects will be randomized to flecainide plus standard therapy first, then crossover to placebo plus standard therapy.~flecainide: oral flecainide will be added to standard therapy with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml"
352131|NCT01117454|O2|Outcome|Placebo|All participants when receving placebo
352132|NCT01117454|O1|Outcome|Flecainide|All participants when receiving flecainide
352133|NCT01117454|E2|Reported Event|Placebo|All participants when receving placebo
352134|NCT01117454|E1|Reported Event|Flecainide|All participants when receiving flecainide
352135|NCT01117428|B7|Baseline|Total|Total of all reporting groups
352136|NCT01117428|B6|Baseline|Part F: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 9 mg/kg loading dose followed by 6 mg/kg, weekly – i.v. infusions"
352137|NCT01117428|B5|Baseline|Part E: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 18 mg/kg, once every 2 weeks – i.v. infusions"
352138|NCT01117428|B4|Baseline|Part D: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 12 mg/kg, once every 2 weeks – i.v. infusions"
352139|NCT01117428|B3|Baseline|Part C: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 9 mg/kg, weekly – i.v. infusions"
352140|NCT01117428|B2|Baseline|Part B: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 12 mg/kg, weekly – i.v. infusions"
352141|NCT01117428|B1|Baseline|Part A: Dose Escalation|"Dose escalation in patients with refractory or recurrent advanced solid tumors.~Sym004: 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly – i.v. infusions"
352153|NCT01117428|O1|Outcome|Part A: Dose Escalation|"Dose escalation in patients with refractory or recurrent advanced solid tumors.~Sym004: 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly – i.v. infusions"
352154|NCT01117428|O6|Outcome|Part F: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 9 mg/kg loading dose followed by 6 mg/kg, weekly - i.v. infusions"
352155|NCT01117428|O5|Outcome|Part E: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 18 mg/kg, once every 2 weeks - i.v. infusions"
352156|NCT01117428|O4|Outcome|Part D: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 12 mg/kg, once every 2 weeks - i.v. infusions"
352157|NCT01117428|O3|Outcome|Part C: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 9 mg/kg, weekly - i.v. infusions"
352158|NCT01117428|O2|Outcome|Part B: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 12 mg/kg, weekly - i.v. infusions"
352159|NCT01117428|O1|Outcome|Part A: Dose Escalation|"Dose escalation in patients with refractory or recurrent advanced solid tumors.~Sym004: 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly - i.v. infusions"
352160|NCT01117428|O6|Outcome|Part F: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 9 mg/kg loading dose followed by 6 mg/kg, weekly – i.v. infusions"
352161|NCT01117428|O5|Outcome|Part E: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 18 mg/kg, once every 2 weeks – i.v. infusions"
352162|NCT01117428|O4|Outcome|Part D: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 12 mg/kg, once every 2 weeks – i.v. infusions"
352163|NCT01117428|O3|Outcome|Part C: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 9 mg/kg weekly - i.v. infusions"
352164|NCT01117428|O2|Outcome|Part B: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 12 mg/kg, weekly – i.v. infusions"
352165|NCT01117428|O1|Outcome|Part A: Dose Escalation|"Dose escalation in patients with refractory or recurrent advanced solid tumors.~Sym004: 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly – i.v. infusions"
352166|NCT01117428|O6|Outcome|Part F: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 9 mg/kg loading dose followed by 6 mg/kg, weekly – i.v. infusions"
352167|NCT01117428|O5|Outcome|Part E: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 18 mg/kg, once every 2 weeks – i.v. infusions"
352168|NCT01117428|O4|Outcome|Part D: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 12 mg/kg, once every 2 weeks – i.v. infusions"
352169|NCT01117428|O3|Outcome|Part C: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 9 mg/kg, weekly – i.v. infusions"
352170|NCT01117428|O2|Outcome|Part B: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004: 12 mg/kg, weekly – i.v. infusions"
352171|NCT01117428|O1|Outcome|Part A: Dose Escalation|"Dose escalation in patients with refractory or recurrent advanced solid tumors.~Sym004: 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly – i.v. infusions"
352172|NCT01117428|E6|Reported Event|Part F: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004 - 9 mg/kg loading dose followed by 6 mg/kg, weekly – i.v. infusions"
352173|NCT01117428|E5|Reported Event|Part E: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004 - 18 mg/kg, once every 2 weeks – i.v. infusions"
352174|NCT01117428|E4|Reported Event|Part D: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004 - 12 mg/kg, once every 2 weeks – i.v. infusions"
352175|NCT01117428|E3|Reported Event|Part C: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004 - 9 mg/kg, weekly – i.v. infusions"
352176|NCT01117428|E2|Reported Event|Part B: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.~Sym004 - 12 mg/kg, weekly – i.v. infusions"
352177|NCT01117428|E1|Reported Event|Part A: Dose Escalation|"Dose escalation in patients with refractory or recurrent advanced solid tumors.~Sym004 - 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly – i.v. infusions"
352178|NCT01117350|B3|Baseline|Total|Total of all reporting groups
352179|NCT01117350|B2|Baseline|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
352180|NCT01117350|B1|Baseline|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
352181|NCT01117350|P2|Participant Flow|Liraglutide (Comparative Period)/ Insulin Glargine (Extension)|"Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24 (comparative period)~For patients included in the extension period: Insulin Glargine (dosing same as above)"
352182|NCT01117350|P1|Participant Flow|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
352183|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
352184|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
352185|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
352274|NCT01117051|E2|Reported Event|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
352186|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
352187|NCT01117350|O1|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
352188|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
352189|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
352190|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
352191|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
352192|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
352193|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
352194|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
352195|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
352196|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
352197|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
352198|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
352199|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
352200|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
352201|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
352202|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
352203|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
352204|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
352205|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
352206|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
352207|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
352208|NCT01117350|E3|Reported Event|Extension Period: Insulin Glargine|"Following a treatment with liraglutide during the comparative period, those patients have received insulin glargine during the extension period.~Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days"
352209|NCT01117350|E2|Reported Event|Comparative Period: Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24 (comparative period)
352210|NCT01117350|E1|Reported Event|Comparative Period: Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
352211|NCT01117337|B3|Baseline|Total|Total of all reporting groups
352212|NCT01117337|B2|Baseline|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
352213|NCT01117337|B1|Baseline|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
352214|NCT01117337|P2|Participant Flow|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
352215|NCT01117337|P1|Participant Flow|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
352216|NCT01117337|O2|Outcome|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
352217|NCT01117337|O1|Outcome|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
352218|NCT01117337|O2|Outcome|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
352219|NCT01117337|O1|Outcome|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
352220|NCT01117337|O2|Outcome|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
352225|NCT01117311|P2|Participant Flow|VNB on First, Then VNB Off|Subjects assigned to this reporting group had the vagal nerve blocker (VNB) on first for the first intervention (Mixed Meal 2), then VNB off for the second intervention (Mixed Meal 3).
352226|NCT01117311|P1|Participant Flow|VNB Off First, Then VNB on|Subjects assigned to this reporting group had the vagal nerve blocker (VNB) off first for the first intervention (Mixed Meal 2), then VNB on for the second intervention (Mixed Meal 3).
352227|NCT01117311|O2|Outcome|VNB Off|The implanted Vagal Nerve Blocker will be off at the time of study.
352228|NCT01117311|O1|Outcome|VNB on|The implanted Vagal Nerve Blocker will be on at the time of study.
352229|NCT01117311|O2|Outcome|VNB Off|The implanted Vagal Nerve Blocker will be off at the time of study.
352230|NCT01117311|O1|Outcome|VNB on|The implanted Vagal Nerve Blocker will be on at the time of study.
352231|NCT01117311|E2|Reported Event|VNB on|The implanted Vagal Nerve Blocker will be on at the time of study.
352232|NCT01117311|E1|Reported Event|VNB Off|The implanted Vagal Nerve Blocker will be off at the time of study.
352233|NCT01117181|B3|Baseline|Total|Total of all reporting groups
352234|NCT01117181|B2|Baseline|Placebo|matching placebo and psychosocial intervention
352235|NCT01117181|B1|Baseline|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
352236|NCT01117181|P2|Participant Flow|Placebo|matching placebo and psychosocial intervention
352237|NCT01117181|P1|Participant Flow|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
352238|NCT01117181|O2|Outcome|Placebo|matching placebo and psychosocial intervention
352239|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
352240|NCT01117181|O2|Outcome|Placebo|Placebo and psychosocial intervention
352241|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day), and psychosocial intervention
352242|NCT01117181|O2|Outcome|Placebo|matching placebo and psychosocial intervention
352243|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
352244|NCT01117181|O2|Outcome|Placebo|matching placebo and psychosocial intervention
352245|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
352246|NCT01117181|O2|Outcome|Placebo|Placebo and psychosocial intervention
352247|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day), and psychosocial intervention
352248|NCT01117181|O2|Outcome|Placebo|Placebo and psychosocial intervention
352249|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day), and psychosocial intervention
352250|NCT01117181|O2|Outcome|Placebo|Placebo and psychosocial intervention
352251|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day), and psychosocial intervention
352252|NCT01117181|E2|Reported Event|Placebo|matching placebo and psychosocial intervention
352253|NCT01117181|E1|Reported Event|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
352254|NCT01117090|B1|Baseline|Intrathecal Pump Patients|Subjects who satisfied all inclusion and exclusion criteria, provided written informed consent, and had a needle inserted into the catheter access port of the implanted pump were considered to be enrolled in the study
352255|NCT01117090|P1|Participant Flow|Intrathecal Pump Patients|Subjects previously implanted with an intrathecal pump who satisfied all inclusion and exclusion criteria, provided written informed consent, and had a needle inserted into the catheter access port of the implanted pump were considered to be enrolled in the study
352256|NCT01117090|O2|Outcome|Subjects With Catheter Complications by Physician Diagnosis|Subjects whose pressure data in response to valsalva were analyzable and who received a diagnosis of catheter complication from the physician
352257|NCT01117090|O1|Outcome|Subjects With Normal Catheter Function by Physician Diagnosis|Subjects whose pressure data in response to valsalva were analyzable and who received a diagnosis of normal catheter function from the physician
352258|NCT01117090|O2|Outcome|Subjects With Catheter Complications by Physician Diagnosis|Subjects whose pressure data in response to cough were analyzable and who received a diagnosis of catheter complication from the physician
352259|NCT01117090|O1|Outcome|Subjects With Normal Catheter Function by Physician Diagnosis|Subjects whose pressure data in response to cough were analyzable and who received a diagnosis of normal catheter function from the physician
352260|NCT01117090|O2|Outcome|Subjects With Catheter Complications by Physician Diagnosis|Subjects whose catheter flow resistance check data were analyzable and who received a trouble-shooting diagnosis of catheter complication from the physician
352261|NCT01117090|O1|Outcome|Subjects With Normal Catheter Function by Physician Diagnosis|Subjects whose catheter flow resistance check data were analyzable and who received a trouble-shooting diagnosis of normal catheter function from the physician
352262|NCT01117090|O2|Outcome|Subjects With Catheter Complications by Physician Diagnosis|Subjects whose pressure data were analyzable and who received a trouble-shooting diagnosis of catheter complication from the physician
352263|NCT01117090|O1|Outcome|Subjects With Normal Catheter Function by Physician Diagnosis|Subjects whose pressure data were analyzable and who received a trouble-shooting diagnosis of normal catheter function from the physician
352264|NCT01117090|E1|Reported Event|Intrathecal Pump Patients|Subjects who satisfied all inclusion and exclusion criteria, provided written informed consent, and had a needle inserted into the catheter access port of the implanted pump were considered to be enrolled in the study
352265|NCT01117051|B3|Baseline|Total|Total of all reporting groups
352266|NCT01117051|B2|Baseline|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
352267|NCT01117051|B1|Baseline|Placebo|placebo once daily before breakfast for up to 12 weeks
352268|NCT01117051|P2|Participant Flow|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
352269|NCT01117051|P1|Participant Flow|Placebo|placebo once daily before breakfast for up to 12 weeks
352277|NCT01117012|B2|Baseline|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
352278|NCT01117012|B1|Baseline|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
352279|NCT01117012|P2|Participant Flow|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
352280|NCT01117012|P1|Participant Flow|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 milligram (mg) tablet orally twice daily (q12h).
352281|NCT01117012|O2|Outcome|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
352282|NCT01117012|O1|Outcome|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
352283|NCT01117012|O2|Outcome|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
352284|NCT01117012|O1|Outcome|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
352285|NCT01117012|O2|Outcome|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
352286|NCT01117012|O1|Outcome|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
352287|NCT01117012|O2|Outcome|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
352288|NCT01117012|O1|Outcome|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
352289|NCT01117012|O2|Outcome|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
352290|NCT01117012|O1|Outcome|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
352291|NCT01117012|O2|Outcome|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
352292|NCT01117012|O1|Outcome|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
352293|NCT01117012|O1|Outcome|VX-770|All participants who received VX-770 150 mg tablet orally q12h in Study 105.
352294|NCT01117012|E1|Reported Event|VX-770|All participants who received VX-770 150 mg tablet orally q12h in Study 105.
352295|NCT01116986|B33|Baseline|Total|Total of all reporting groups
352296|NCT01116986|B32|Baseline|32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352297|NCT01116986|B31|Baseline|31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352298|NCT01116986|B30|Baseline|30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352299|NCT01116986|B29|Baseline|29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352300|NCT01116986|B28|Baseline|28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352301|NCT01116986|B27|Baseline|27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352302|NCT01116986|B26|Baseline|26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352303|NCT01116986|B25|Baseline|25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352304|NCT01116986|B24|Baseline|24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352340|NCT01116986|P20|Participant Flow|20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk|How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
352305|NCT01116986|B23|Baseline|23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352306|NCT01116986|B22|Baseline|22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352307|NCT01116986|B21|Baseline|21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352308|NCT01116986|B20|Baseline|20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk|How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
352309|NCT01116986|B19|Baseline|19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt."
352310|NCT01116986|B18|Baseline|18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352311|NCT01116986|B17|Baseline|17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352312|NCT01116986|B16|Baseline|16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352313|NCT01116986|B15|Baseline|15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352314|NCT01116986|B14|Baseline|14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352315|NCT01116986|B13|Baseline|13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352316|NCT01116986|B12|Baseline|12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352317|NCT01116986|B11|Baseline|11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352318|NCT01116986|B10|Baseline|10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352319|NCT01116986|B9|Baseline|9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352320|NCT01116986|B8|Baseline|8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352321|NCT01116986|B7|Baseline|7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352322|NCT01116986|B6|Baseline|6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352323|NCT01116986|B5|Baseline|5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352324|NCT01116986|B4|Baseline|4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352325|NCT01116986|B3|Baseline|3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352326|NCT01116986|B2|Baseline|2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352327|NCT01116986|B1|Baseline|1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352328|NCT01116986|P32|Participant Flow|32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352329|NCT01116986|P31|Participant Flow|31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352330|NCT01116986|P30|Participant Flow|30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352331|NCT01116986|P29|Participant Flow|29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352332|NCT01116986|P28|Participant Flow|28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352333|NCT01116986|P27|Participant Flow|27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352334|NCT01116986|P26|Participant Flow|26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352335|NCT01116986|P25|Participant Flow|25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352336|NCT01116986|P24|Participant Flow|24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352337|NCT01116986|P23|Participant Flow|23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352338|NCT01116986|P22|Participant Flow|22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352339|NCT01116986|P21|Participant Flow|21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352454|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
352552|NCT01116102|O4|Outcome|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
352341|NCT01116986|P19|Participant Flow|19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt."
352342|NCT01116986|P18|Participant Flow|18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352343|NCT01116986|P17|Participant Flow|17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352344|NCT01116986|P16|Participant Flow|16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352345|NCT01116986|P15|Participant Flow|15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352346|NCT01116986|P14|Participant Flow|14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352347|NCT01116986|P13|Participant Flow|13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352348|NCT01116986|P12|Participant Flow|12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352349|NCT01116986|P11|Participant Flow|11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352350|NCT01116986|P10|Participant Flow|10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352351|NCT01116986|P9|Participant Flow|9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352352|NCT01116986|P8|Participant Flow|8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352353|NCT01116986|P7|Participant Flow|7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352354|NCT01116986|P6|Participant Flow|6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352355|NCT01116986|P5|Participant Flow|5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352356|NCT01116986|P4|Participant Flow|4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352357|NCT01116986|P3|Participant Flow|3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352455|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
352553|NCT01116102|O3|Outcome|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
352358|NCT01116986|P2|Participant Flow|2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
352359|NCT01116986|P1|Participant Flow|1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
352360|NCT01116986|O12|Outcome|Long Term (26 Weeks) Postquit Nicotine Patch + Nicotine Gum|Participants randomized to this condition received Long Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt. The Long Term Combo NRT group consists of 304 participants (approximately half the total sample of 637) who will be compared with a group that received Long Term Combo NRT group (N=333; approximately half the total sample) in a main effect statistical comparison (Short Term Combo NRT vs. Long Term Combo NRT).
352361|NCT01116986|O11|Outcome|Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum|Participants randomized to this condition received Short Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt. The Short Term Combo NRT group consists of 333 participants (approximately half the total sample of 637) who will be compared with a group that received Long Term Combo NRT group (N=304; approximately half the total sample) in a main effect statistical comparison (Short Term Combo NRT vs. Long Term Combo NRT).
352362|NCT01116986|O10|Outcome|Intensive Phone Counseling During the Quit Attempt|Participants randomized to this condition received Intensive Phone Counseling During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Intensive Phone Counseling During the Quit Attempt group consists of 320 participants (approximately half the total sample of 637) who will be compared with a group that received Minimal Phone Counseling During the Quit Attempt (N=317; approximately half the total sample) in a main effect statistical comparison (Minimal Phone Counseling During the Quit Attempt vs Intensive Phone Counseling During the Quit Attempt).
352363|NCT01116986|O9|Outcome|Minimal Phone Counseling During the Quit Attemp|Participants randomized to this condition received Minimal Phone Counseling During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Minimal Phone Counseling During the Quit Attempt group consists of 317 participants (approximately half the total sample of 637) who will be compared with a group that received Intensive Phone Counseling During the Quit Attempt (N=320; approximately half the total sample) in a main effect statistical comparison (Minimal Phone Counseling During the Quit Attempt vs Intensive Phone Counseling During the Quit Attempt).
352364|NCT01116986|O8|Outcome|Intensive In-person Counseling During the Quit Attempt|Participants randomized to this condition received Intensive In-person Counseling During the Quit Attempt; participants in this group received all combinations of the other 5 study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Intensive In-person Counseling During the Quit Attempt group consists of 314 participants (approximately half the total sample of 637) who will be compared with a group that received Minimal In-person Counseling During the Quit Attempt (N=323; approximately half the total sample) in a main effect statistical comparison (Minimal In-person Counseling During the Quit Attempt vs Intensive In-person Counseling During the Quit Attempt).
352365|NCT01116986|O7|Outcome|Minimal In-person Counseling During the Quit Attempt|Participants randomized to this condition received Minimal In-person Counseling During the Quit Attempt; participants in this group received all combinations of the other 5 study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Minimal In-person Counseling During the Quit Attempt group consists of 323 participants (approximately half the total sample of 637) who will be compared with a group that received Intensive In-person Counseling During the Quit Attempt(N=320; approximately half the total sample) in a main effect statistical comparison (Minimal In-person Counseling During the Quit Attempt vs Intensive In-person Counseling During the Quit Attempt).
352408|NCT01116921|O2|Outcome|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.~Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
352409|NCT01116921|O1|Outcome|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
352554|NCT01116102|O2|Outcome|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
352366|NCT01116986|O6|Outcome|Counseling Before the Quit Attempt|Participants randomized to this condition received Counseling Before the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Counseling Before the Quit Attempt group consists of 317 participants (approximately half the total sample of 637) who will be compared with a group that received No Counseling Before the Quit Attempt (N=320; approximately half the total sample) in a main effect statistical comparison (No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt).
352367|NCT01116986|O5|Outcome|No Counseling Before the Quit Attempt|Participants randomized to this condition received No Counseling Before the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Counseling Before the Quit Attempt group consists of 320 participants (approximately half the total sample of 637) who will be compared with a group that received Counseling Before the Quit Attempt (N=317; approximately half the total sample) in a main effect statistical comparison (No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt).
352368|NCT01116986|O4|Outcome|Pre-Quit Nicotine Gum|Participants randomized to this condition received Pre-Quit Nicotine Gum; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Pre-Quit Nicotine Gum group consists of 339 participants (approximately half the total sample of 637) who will be compared with a group that received No Pre-Quit Nicotine Gum (N=298; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum).
352369|NCT01116986|O3|Outcome|No Pre-Quit Nicotine Gum|Participants randomized to this condition received No Pre-Quit Nicotine Gum; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Pre-Quit Nicotine Gum group consists of 298 participants (approximately half the total sample of 637) who will be compared with a group that received Pre-Quit Nicotine Gum (N=339; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum).
352370|NCT01116986|O2|Outcome|Pre-Quit Nicotine Patch|Participants randomized to this condition received Pre-Quit Nicotine Patch; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Pre-Quit Nicotine Patch group consists of 329 participants (approximately half the total sample of 637) who will be compared with a group that received No Pre-Quit Nicotine Patch (N=308; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch).
352371|NCT01116986|O1|Outcome|No Pre-Quit Nicotine Patch|Participants randomized to this condition received No Pre-Quit Nicotine Patch; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Pre-Quit Nicotine Patch group consists of 308 participants (approximately half the total sample of 637) who will be compared with a group that received Pre-Quit Nicotine Patch (N=329; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch).
352372|NCT01116986|O12|Outcome|Long Term (26 Weeks) Postquit Nicotine Patch + Nicotine Gum|Participants randomized to this condition received Long Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt. The Long Term Combo NRT group consists of 304 participants (approximately half the total sample of 637) who will be compared with a group that received Long Term Combo NRT group (N=333; approximately half the total sample) in a main effect statistical comparison (Short Term Combo NRT vs. Long Term Combo NRT).
352380|NCT01116986|O4|Outcome|Pre-Quit Nicotine Gum|Participants randomized to this condition received Pre-Quit Nicotine Gum; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Pre-Quit Nicotine Gum group consists of 339 participants (approximately half the total sample of 637) who will be compared with a group that received No Pre-Quit Nicotine Gum (N=298; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum).
352373|NCT01116986|O11|Outcome|Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum|Participants randomized to this condition received Short Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt. The Short Term Combo NRT group consists of 333 participants (approximately half the total sample of 637) who will be compared with a group that received Long Term Combo NRT group (N=304; approximately half the total sample) in a main effect statistical comparison (Short Term Combo NRT vs. Long Term Combo NRT).
352374|NCT01116986|O10|Outcome|Intensive Phone Counseling During the Quit Attempt|Participants randomized to this condition received Intensive Phone Counseling During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Intensive Phone Counseling During the Quit Attempt group consists of 320 participants (approximately half the total sample of 637) who will be compared with a group that received Minimal Phone Counseling During the Quit Attempt (N=317; approximately half the total sample) in a main effect statistical comparison (Minimal Phone Counseling During the Quit Attempt vs Intensive Phone Counseling During the Quit Attempt).
352375|NCT01116986|O9|Outcome|Minimal Phone Counseling During the Quit Attemp|Participants randomized to this condition received Minimal Phone Counseling During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Minimal Phone Counseling During the Quit Attempt group consists of 317 participants (approximately half the total sample of 637) who will be compared with a group that received Intensive Phone Counseling During the Quit Attempt (N=320; approximately half the total sample) in a main effect statistical comparison (Minimal Phone Counseling During the Quit Attempt vs Intensive Phone Counseling During the Quit Attempt).
352376|NCT01116986|O8|Outcome|Intensive In-person Counseling During the Quit Attempt|Participants randomized to this condition received Intensive In-person Counseling During the Quit Attempt; participants in this group received all combinations of the other 5 study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Intensive In-person Counseling During the Quit Attempt group consists of 314 participants (approximately half the total sample of 637) who will be compared with a group that received Minimal In-person Counseling During the Quit Attempt (N=323; approximately half the total sample) in a main effect statistical comparison (Minimal In-person Counseling During the Quit Attempt vs Intensive In-person Counseling During the Quit Attempt).
352377|NCT01116986|O7|Outcome|Minimal In-person Counseling During the Quit Attempt|Participants randomized to this condition received Minimal In-person Counseling During the Quit Attempt; participants in this group received all combinations of the other 5 study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Minimal In-person Counseling During the Quit Attempt group consists of 323 participants (approximately half the total sample of 637) who will be compared with a group that received Intensive In-person Counseling During the Quit Attempt(N=320; approximately half the total sample) in a main effect statistical comparison (Minimal In-person Counseling During the Quit Attempt vs Intensive In-person Counseling During the Quit Attempt).
352378|NCT01116986|O6|Outcome|Counseling Before the Quit Attempt|Participants randomized to this condition received Counseling Before the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Counseling Before the Quit Attempt group consists of 317 participants (approximately half the total sample of 637) who will be compared with a group that received No Counseling Before the Quit Attempt (N=320; approximately half the total sample) in a main effect statistical comparison (No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt).
352379|NCT01116986|O5|Outcome|No Counseling Before the Quit Attempt|Participants randomized to this condition received No Counseling Before the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Counseling Before the Quit Attempt group consists of 320 participants (approximately half the total sample of 637) who will be compared with a group that received Counseling Before the Quit Attempt (N=317; approximately half the total sample) in a main effect statistical comparison (No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt).
352406|NCT01116921|O2|Outcome|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.~Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
352407|NCT01116921|O1|Outcome|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
352381|NCT01116986|O3|Outcome|No Pre-Quit Nicotine Gum|Participants randomized to this condition received No Pre-Quit Nicotine Gum; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Pre-Quit Nicotine Gum group consists of 298 participants (approximately half the total sample of 637) who will be compared with a group that received Pre-Quit Nicotine Gum (N=339; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum).
352382|NCT01116986|O2|Outcome|Pre-Quit Nicotine Patch|Participants randomized to this condition received Pre-Quit Nicotine Patch; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Pre-Quit Nicotine Patch group consists of 329 participants (approximately half the total sample of 637) who will be compared with a group that received No Pre-Quit Nicotine Patch (N=308; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch).
352383|NCT01116986|O1|Outcome|No Pre-Quit Nicotine Patch|Participants randomized to this condition received No Pre-Quit Nicotine Patch; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Pre-Quit Nicotine Patch group consists of 308 participants (approximately half the total sample of 637) who will be compared with a group that received Pre-Quit Nicotine Patch (N=329; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch).
352384|NCT01116986|E6|Reported Event|Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum|"Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum~Participants randomized to this condition received Short Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt."
352385|NCT01116986|E5|Reported Event|Long Term (16 Weeks) Postquit Nicotine Patch + Nicotine Gum|"Long Term (16 Weeks) Postquit Nicotine Patch + Nicotine Gum~Participants randomized to this condition received Long Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt."
352386|NCT01116986|E4|Reported Event|No Pre-Quit Nicotine Patch Nor Gum|"No Pre-Quit Nicotine Patch nor Gum~Participants randomized to this condition received neither the Pre-Quit Nicotine Patch nor the Pre-Quit Nicotine Gum."
352387|NCT01116986|E3|Reported Event|Pre-Quit Nicotine Gum|"Pre-Quit Nicotine Gum~Participants randomized to this condition received Pre-Quit Nicotine Gum.~Before quitting: Everyone had one 14 mg nicotine patch per day for 2 weeks before the target quit day."
352388|NCT01116986|E2|Reported Event|Pre-Quit Nicotine Patch|"Pre-Quit Nicotine Patch~Participants randomized to this condition received Pre-Quit Nicotine Patch.~Before quitting: Everyone had one 14 mg nicotine patch per day for 2 weeks before the target quit day."
352389|NCT01116986|E1|Reported Event|Pre-Quit Nicotine Gum and Pre-Quit Nicotine Patch|"Pre-Quit Nicotine Gum and Pre-Quit Nicotine Patch~Participants randomized to this condition received Pre-Quit Nicotine Gum and Pre-Quit Nicotine Patch.~Before quitting: Everyone had ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day."
352390|NCT01116934|B3|Baseline|Total|Total of all reporting groups
352391|NCT01116934|B2|Baseline|Healthy Controls|9 healthy donors
352392|NCT01116934|B1|Baseline|PLS Patients|8 PLS patients (one female) from 6 families
352393|NCT01116934|P2|Participant Flow|Healthy Controls|9 healthy donors
352394|NCT01116934|P1|Participant Flow|Papillon-Lefèvre Syndrome (PLS) Patients|8 PLS patients (one female) from 6 families
352395|NCT01116934|O2|Outcome|Healthy Controls|9 healthy donors
352396|NCT01116934|O1|Outcome|Papillon-Lefèvre Syndrome (PLS) Patients|8 PLS patients (one female) from 6 families
352397|NCT01116934|E2|Reported Event|Healthy Controls|9 healthy donors
352398|NCT01116934|E1|Reported Event|PLS Patients|8 PLS patients (one female) from 6 families
352399|NCT01116921|B3|Baseline|Total|Total of all reporting groups
352400|NCT01116921|B2|Baseline|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.~Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
352401|NCT01116921|B1|Baseline|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
352402|NCT01116921|P2|Participant Flow|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.~Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
352403|NCT01116921|P1|Participant Flow|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
352404|NCT01116921|O2|Outcome|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.~Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
352405|NCT01116921|O1|Outcome|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
352452|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
352453|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
352410|NCT01116921|O2|Outcome|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.~Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
352411|NCT01116921|O1|Outcome|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
352412|NCT01116921|O2|Outcome|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.~Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
352413|NCT01116921|O1|Outcome|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
352414|NCT01116921|O2|Outcome|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.~Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
352415|NCT01116921|O1|Outcome|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
352416|NCT01116921|E2|Reported Event|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.~Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
352417|NCT01116921|E1|Reported Event|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
352418|NCT01116882|B3|Baseline|Total|Total of all reporting groups
352419|NCT01116882|B2|Baseline|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
352420|NCT01116882|B1|Baseline|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
352421|NCT01116882|P2|Participant Flow|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
352422|NCT01116882|P1|Participant Flow|PCI at a Hospital Without On-site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
352423|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
352424|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
352425|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
352426|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
352427|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
352428|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
352429|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
352430|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
352431|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
352432|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
352433|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery in the angiographic cohort
352434|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery in the angiographic cohort
352435|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery in the angiographic cohort
352436|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery in the angiographic cohort
352437|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
352438|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
352439|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery in the angiographic cohort
352440|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery in the angiographic cohort
352441|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
352442|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
352443|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
352444|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
352445|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
352446|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery.
352447|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
352448|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
352449|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
352450|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
352451|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
352456|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
352457|NCT01116882|E2|Reported Event|Surgery-On-Site (SOS)|Patients randomized to the SOS arm are transferred to tertiary hospitals for their PCI procedure.
352458|NCT01116882|E1|Reported Event|Non-Surgery-On-Site (Non-SOS)|Patients in the non-SOS arm are randomized to stay at the community hospitals for their PCI procedure.
352459|NCT01116687|B1|Baseline|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
352460|NCT01116687|P1|Participant Flow|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
352461|NCT01116687|O1|Outcome|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
352462|NCT01116687|O1|Outcome|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
352463|NCT01116687|O1|Outcome|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
352464|NCT01116687|O1|Outcome|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
352465|NCT01116687|E1|Reported Event|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
352466|NCT01116466|B1|Baseline|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
352467|NCT01116466|P1|Participant Flow|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
352468|NCT01116466|O1|Outcome|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
352469|NCT01116466|O1|Outcome|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
352470|NCT01116466|O1|Outcome|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
352471|NCT01116466|O1|Outcome|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
352472|NCT01116466|O1|Outcome|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
352473|NCT01116466|E1|Reported Event|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
352474|NCT01116427|B3|Baseline|Total|Total of all reporting groups
352475|NCT01116427|B2|Baseline|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352476|NCT01116427|B1|Baseline|Abatacept First, Then Placebo|Subjects received abatacept IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows: Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352477|NCT01116427|P2|Participant Flow|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352478|NCT01116427|P1|Participant Flow|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352479|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352480|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352481|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352482|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352517|NCT01116401|E1|Reported Event|GnRH Agonist Injection|One 3.75-mg intramuscular injection of leuprolide acetate
352555|NCT01116102|O1|Outcome|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
352556|NCT01116102|O8|Outcome|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
352483|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352484|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352485|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352486|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352487|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352488|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352489|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352490|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352491|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352492|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352493|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352494|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352495|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352496|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352497|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352498|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352499|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352500|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352501|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352502|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352503|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352504|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352505|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352506|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
352507|NCT01116427|E6|Reported Event|Follow-up Phase: Placebo -> Abatacept|Following Week 52, participants in the Placebo -> Abatacept group completed an additional 12 weeks of observation until week 64.
352508|NCT01116427|E5|Reported Event|Follow-up Phase: Abatacept -> Placebo|Following Week 52, participants in the Abatacept -> Placebo group completed an additional 12 weeks of observation until week 64.
352509|NCT01116427|E4|Reported Event|Extension Phase: Placebo -> Abatacept|"After week 24, participants in the Placebo -> Abatacept group eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Dosing of abatacept was as follows:~Participants weighing-~less than 60 kg received 500 mg;~60-100 kg received 750 mg; and~greater than 100 kg received 1 g."
352510|NCT01116427|E3|Reported Event|Extension Phase: Abatacept -> Placebo|After week 24, participants in Abatacept -> Placebo group eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52.
352511|NCT01116427|E2|Reported Event|Core Phase: Placebo -> Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24.
352512|NCT01116427|E1|Reported Event|Core Phase: Abatacept -> Placebo|"Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. Dosing of abatacept was as follows:~Participants weighing-~less than 60 kg received 500 mg;~60-100 kg received 750 mg; and~greater than 100 kg received 1 g."
352513|NCT01116401|B1|Baseline|GnRH Agonist Injection|One 3.75-mg intramuscular injection of leuprolide acetate
352514|NCT01116401|P1|Participant Flow|GnRH Agonist Injection|One 3.75-mg intramuscular injection of leuprolide acetate
352515|NCT01116401|O1|Outcome|GnRH Agonist Injection|One 3.75-mg intramuscular injection of leuprolide acetate
352516|NCT01116401|O1|Outcome|GnRH Agonist Injection|One 3.75-mg intramuscular injection of leuprolide acetate
352518|NCT01116232|B1|Baseline|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter~Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;~For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).~Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.~peripheral blood stem cell transplantation~sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow"
352519|NCT01116232|P1|Participant Flow|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter~Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;~For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).~Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.~peripheral blood stem cell transplantation~sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow"
352520|NCT01116232|O1|Outcome|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"Anti-thymocyte globulin infuse the 1st dose, minimum of 6 hrs subsequent doses minimum of 4 hrs via a 0.22 micron in-line filter~Rituximab, total dose is 28 mg/kg divided in 2 doses (14 mg/kg, days -7 & +3) Initial infusion, start rate 50 mg/hour~Sirolimus 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).~Tacrolimus (IV) dose of 0.03 mg/kg (ideal body weight) every 24hr by continuous infusion starting on Day -3, discontinued once the pt. starts eating & the drug will then be given orally at a dose of approximately 4 times the IV dose."
352521|NCT01116232|O1|Outcome|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter~Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;~For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).~Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.~peripheral blood stem cell transplantation~sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow"
352522|NCT01116232|E1|Reported Event|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter~Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;~For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).~Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.~peripheral blood stem cell transplantation~sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow"
352523|NCT01116102|B9|Baseline|Total|Total of all reporting groups
352524|NCT01116102|B8|Baseline|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
352525|NCT01116102|B7|Baseline|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
352526|NCT01116102|B6|Baseline|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
352527|NCT01116102|B5|Baseline|25 ga Needle, Dose Flush, Single-step Rate Scheme|
352528|NCT01116102|B4|Baseline|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
352529|NCT01116102|B3|Baseline|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
352530|NCT01116102|B2|Baseline|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
352531|NCT01116102|B1|Baseline|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
352532|NCT01116102|P8|Participant Flow|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
352533|NCT01116102|P7|Participant Flow|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
352534|NCT01116102|P6|Participant Flow|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
352535|NCT01116102|P5|Participant Flow|25 ga Needle, Dose Flush, Single-step Rate Scheme|
352536|NCT01116102|P4|Participant Flow|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
352537|NCT01116102|P3|Participant Flow|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
352538|NCT01116102|P2|Participant Flow|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
352539|NCT01116102|P1|Participant Flow|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
352540|NCT01116102|O8|Outcome|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
352541|NCT01116102|O7|Outcome|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
352542|NCT01116102|O6|Outcome|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
352543|NCT01116102|O5|Outcome|25 ga Needle, Dose Flush, Single-step Rate Scheme|
352544|NCT01116102|O4|Outcome|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
352545|NCT01116102|O3|Outcome|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
352546|NCT01116102|O2|Outcome|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
352547|NCT01116102|O1|Outcome|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
352548|NCT01116102|O8|Outcome|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
352549|NCT01116102|O7|Outcome|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
352857|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
352557|NCT01116102|O7|Outcome|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
352558|NCT01116102|O6|Outcome|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
352559|NCT01116102|O5|Outcome|25 ga Needle, Dose Flush, Single-step Rate Scheme|
352560|NCT01116102|O4|Outcome|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
352561|NCT01116102|O3|Outcome|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
352562|NCT01116102|O2|Outcome|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
352563|NCT01116102|O1|Outcome|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
352564|NCT01116102|O8|Outcome|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
352565|NCT01116102|O7|Outcome|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
352566|NCT01116102|O6|Outcome|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
352567|NCT01116102|O5|Outcome|25 ga Needle, Dose Flush, Single-step Rate Scheme|
352568|NCT01116102|O4|Outcome|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
352569|NCT01116102|O3|Outcome|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
352570|NCT01116102|O2|Outcome|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
352571|NCT01116102|O1|Outcome|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
352572|NCT01116102|E8|Reported Event|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
352573|NCT01116102|E7|Reported Event|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
352574|NCT01116102|E6|Reported Event|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
352575|NCT01116102|E5|Reported Event|25 ga Needle, Dose Flush, Single-step Rate Scheme|
352576|NCT01116102|E4|Reported Event|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
352577|NCT01116102|E3|Reported Event|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
352578|NCT01116102|E2|Reported Event|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
352579|NCT01116102|E1|Reported Event|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
352580|NCT01116037|B1|Baseline|ATS 3f Aortic Bioprosthesis|"ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis)~ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve"
352581|NCT01116037|P1|Participant Flow|ATS 3f Aortic Bioprosthesis|"ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis)~ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve"
352582|NCT01116037|O1|Outcome|ATS 3f Aortic Bioprosthesis|"ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis)~ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve"
352583|NCT01116037|O1|Outcome|ATS 3f Aortic Bioprosthesis|"ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis)~ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve"
352584|NCT01116037|E1|Reported Event|ATS 3f Aortic Bioprosthesis|"ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis)~ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve"
352585|NCT01116024|B1|Baseline|Aortic Valve Replacement|3f Enable Aortic Bioprosthesis Model 6000
352586|NCT01116024|P1|Participant Flow|ATS 3f Enable Aortic Bioprosthesis Model 6000|ATS 3f Enable Aortic Bioprosthesis Model 6000 : Replacement Aortic Heart Valve
352587|NCT01116024|O7|Outcome|5 Years|Effective Orifice Area at 5 years
352588|NCT01116024|O6|Outcome|4 Years|Effective Orifice Area at 4 years
352589|NCT01116024|O5|Outcome|3 Years|Effective Orifice Area at 3 years
352590|NCT01116024|O4|Outcome|2 Years|Effective Orifice Area at 2 years
352591|NCT01116024|O3|Outcome|11-14 Months|Effective Orifice Area at 11-14 months
352592|NCT01116024|O2|Outcome|3-6 Months|Effective Orifice Area at 3-6 months
352593|NCT01116024|O1|Outcome|Discharge|Effective Orifice Area at discharge
352594|NCT01116024|O7|Outcome|5 Years|Effective Orifice Area at 5 years
352595|NCT01116024|O6|Outcome|4 Years|Effective Orifice Area at 4 years
352596|NCT01116024|O5|Outcome|3 Years|Effective Orifice Area at 3 years
352597|NCT01116024|O4|Outcome|2 Years|Effective Orifice Area at 2 years
352598|NCT01116024|O3|Outcome|11-14 Months|Effective Orifice Area at 11-14 months
352599|NCT01116024|O2|Outcome|3-6 Months|Effective Orifice Area at 3-6 months
352600|NCT01116024|O1|Outcome|Discharge|Effective Orifice Area at discharge
352601|NCT01116024|O7|Outcome|5 Years|Gradient at 5 Years
352602|NCT01116024|O6|Outcome|4 Years|Gradient at 4 Years
352603|NCT01116024|O5|Outcome|3 Years|Gradient at 3 Years
352604|NCT01116024|O4|Outcome|2 Years|Gradient at 2 Years
352605|NCT01116024|O3|Outcome|11-14 Months|Gradient at 11-14 months
352606|NCT01116024|O2|Outcome|3-6 Months|Gradient at 3-6 Months
352607|NCT01116024|O1|Outcome|Discharge|Gradient at discharge
352608|NCT01116024|O7|Outcome|NYHA Class 5 Year|NYHA classification after 5 years.
352609|NCT01116024|O6|Outcome|NYHA Class 4 Year|NYHA classification after 4 years.
352610|NCT01116024|O5|Outcome|NYHA Class 3 Year|NYHA classification after 3 years.
352611|NCT01116024|O4|Outcome|NYHA Class 2 Year|NYHA classification after 2 years.
352612|NCT01116024|O3|Outcome|NYHA Class 11-14 Months|NYHA classification after 11-14 months.
352613|NCT01116024|O2|Outcome|NYHA Class 3-6 Months|NYHA classification after 3-6 months.
352614|NCT01116024|O1|Outcome|NYHA Class Preoperative|Preoperative numbers of NYHA classification.
352615|NCT01116024|O1|Outcome|Enable I Model 6000 Valve: Replacement Aortic Heart Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
352616|NCT01116024|O1|Outcome|Enable I Model 6000 Valve: Replacement Aortic Heart Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
352617|NCT01116024|O1|Outcome|Enable I Model 6000 Valve: Replacement Aortic Heart Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
352618|NCT01116024|O1|Outcome|Enable I Model 6000 Valve: Replacement Aortic Heart Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
352619|NCT01116024|O1|Outcome|Enable I Model 6000 Valve: Replacement Aortic Heart Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
352620|NCT01116024|O1|Outcome|Enable I Model 6000 Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
352621|NCT01116024|O1|Outcome|Enable I Model 6000 Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
352622|NCT01116024|O1|Outcome|Enable I Model 6000 Valve: Replacement Aortic Heart Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
352623|NCT01116024|E1|Reported Event|Enable I Model 6000 Valve|Adverse events relating to the study safety endpoints.
352624|NCT01115998|B3|Baseline|Total|Total of all reporting groups
352625|NCT01115998|B2|Baseline|Control Group|Children received usual early intervention services, but no power wheelchair.
352626|NCT01115998|B1|Baseline|Power Wheelchair|
352627|NCT01115998|P2|Participant Flow|Control Group|The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
352628|NCT01115998|P1|Participant Flow|Power Wheelchair|Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children’s early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.
352629|NCT01115998|O2|Outcome|Control Group|The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
352630|NCT01115998|O1|Outcome|Power Wheelchair|Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children’s early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.
352631|NCT01115998|O2|Outcome|Control Group|The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
352632|NCT01115998|O1|Outcome|Power Wheelchair|Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children’s early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.
352633|NCT01115998|O2|Outcome|Control Group|The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
352634|NCT01115998|O1|Outcome|Power Wheelchair|Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children’s early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.
352635|NCT01115998|E2|Reported Event|Control Group|The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
352636|NCT01115998|E1|Reported Event|Power Wheelchair|Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children’s early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.
352637|NCT01115933|B1|Baseline|XIENCE PRIME SV EECSS|"XIENCE PRIME SV Everolimus Eluting Coronary Stent System~XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS"
352638|NCT01115933|P1|Participant Flow|XIENCE PRIME SV EECSS|"XIENCE PRIME SV EECSS: XIENCE PRIME Small Vessel (2.25 mm) Everolimus Eluting Coronary Stent System~XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS"
352639|NCT01115933|O5|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable/Possible|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352640|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352858|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
352641|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - ST Possible|"XIENCE PRIME SV EECSS: Small Vessel Everolimus Eluting Coronary Stent System~XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS"
352642|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - ST Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352643|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - ST Definite|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352644|NCT01115933|O5|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable/Possible|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352645|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352646|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - ST Possible|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352647|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS- ST Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352648|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - ST Definite|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352649|NCT01115933|O5|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable/Possible|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
352650|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352651|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - ST Possible|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
352652|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - ST Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352653|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - ST Definite|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
352654|NCT01115933|O5|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable/Possible|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352655|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352656|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - ST Possible|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
352657|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - ST Probable|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
352658|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - ST Definite|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352659|NCT01115933|O5|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable/Possible|XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
352660|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352661|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - ST Possible|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352662|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - ST Probable|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
352663|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - ST Definite|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352664|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352665|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
352666|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
352667|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
352668|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
352669|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
352670|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352671|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352672|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352673|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352674|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352675|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
352676|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352677|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
352678|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352679|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352680|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
352681|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352682|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352683|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352684|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352685|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - NTV-NQMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352686|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - NTV-QMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352687|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - NTV-NQMI Per Protocol|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
352688|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - NTV-QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352689|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS Non-Target Vessel NQMI Per ARC|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
352690|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS Non-Target Vessel QMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352691|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS Non-Target Vessel NQMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352692|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS Non-Target Vessel QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352693|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - TV-NQMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352694|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - TV-QMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352695|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - TV-NQMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352696|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - TV-QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352697|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - TV-NQMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352698|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - TV-QMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352699|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - TV-NQMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352700|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS- TV-QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352701|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - NQMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352702|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - QMI Per ARC|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
352703|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - NQMI Per Protocol|XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
352704|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352705|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - NQMI Per ARC Definitions|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352706|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - QMI Per ARC Definitions|XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
352707|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - NQMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352708|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352709|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - Non-Cardiovascular Death Per ARC|XIENCE PRIME SV EECSS : Patients receiving AXIENCE PRIME SV EECSS
352710|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - Vascular Death Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352711|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - Cardiac Death Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352712|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - All Death Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352713|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - Non-Cardiovascular|XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
352714|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - Vascular|XIENCE PRIME SV EECSS : Patients receiving AXIENCE PRIME SV EECSS
352715|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - Cardiac|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352716|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS ABR Distal|XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
352717|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS ABR Proximal|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352718|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS ABR In-stent|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352719|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS ABR In-segment|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352720|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS LL Distal|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352721|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS LL Proximal|XIENCE PRIME SV EECSS: Patients receivingXIENCE PRIME SV EECSS
352722|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS LL In-stent|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352723|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS LL In-segment|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352724|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS %DS Distal|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352725|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS %DS Proximal|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
352726|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS %DS In-stent|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
352727|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS %DS In-segment|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352728|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS EECSS : Patients receiving XIENCE PRIME SV EECSS
352729|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352730|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
352731|NCT01115933|E1|Reported Event|AVJ-09-385 SV EECSS|"SV EECSS: Small Vessel Everolimus Eluting Coronary Stent System~AVJ-09-385 EECSS : Patients receiving AVJ-09-385 EECSS"
352732|NCT01115855|B3|Baseline|Total|Total of all reporting groups
352733|NCT01115855|B2|Baseline|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
352734|NCT01115855|B1|Baseline|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
352735|NCT01115855|P2|Participant Flow|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
352859|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
352736|NCT01115855|P1|Participant Flow|Eplerenone|Participants with estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 50 milliliter per minute divided by 1.73 squared meter (mL/min/1.73m^2) received eplerenone 25 milligram (mg) tablet once daily up to Week 4 and participants with eGFR 30 to less than (<) 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. . From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
352737|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
352738|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
352739|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
352740|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
352741|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
352742|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
352743|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
352744|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
352745|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
352746|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
352747|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
352748|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
352749|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
352750|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
352751|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
352752|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
352753|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
352754|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
352755|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
352756|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
352757|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
352758|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
352759|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
352760|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
352761|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
352762|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
352763|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
352764|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
352765|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
352766|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
352767|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
352768|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
352769|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
352860|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
352861|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
352770|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
352771|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
352772|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
352773|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
352774|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
352775|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
352776|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
352777|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
352778|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
352779|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
352780|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
352781|NCT01115855|E2|Reported Event|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
352782|NCT01115855|E1|Reported Event|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
352783|NCT01115738|B4|Baseline|Total|Total of all reporting groups
352784|NCT01115738|B3|Baseline|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352785|NCT01115738|B2|Baseline|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352786|NCT01115738|B1|Baseline|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352787|NCT01115738|P3|Participant Flow|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352788|NCT01115738|P2|Participant Flow|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352862|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
352789|NCT01115738|P1|Participant Flow|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352790|NCT01115738|O6|Outcome|600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 RM|CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352791|NCT01115738|O5|Outcome|600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 EM|CYP2C19 extensive metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352792|NCT01115738|O4|Outcome|600 mg Clopidogrel and 60 mg Prasugrel - CYP2C19 RM|CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352793|NCT01115738|O3|Outcome|600 mg Clopidogrel and 60 mg Prasugrel - CYP2C19 EM|CYP2C19 extensive metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352794|NCT01115738|O2|Outcome|Placebo and 60 mg Prasugrel -CYP2C19 RM|CYP2C19 reduced metabolizers treated with placebo LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352795|NCT01115738|O1|Outcome|Placebo and 60 mg Prasugrel-CYP2C19 EM|CYP2C19 extensive metabolizers treated with placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352796|NCT01115738|O2|Outcome|Clopidogrel at Baseline - CYP2C19 RM|600-mg clopidogrel LD administered once orally before PCI.
352797|NCT01115738|O1|Outcome|Clopidogrel at Baseline -CYP2C19 EM|600-milligram (mg) clopidogrel loading dose (LD) administered once orally before percutaneous coronary intervention (PCI).
352798|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352799|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352800|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352801|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352802|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352803|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352804|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352805|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352806|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352807|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352808|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352809|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352810|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352811|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352812|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352813|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352814|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352815|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352816|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352817|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352818|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352819|NCT01115738|E3|Reported Event|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352820|NCT01115738|E2|Reported Event|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352821|NCT01115738|E1|Reported Event|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
352822|NCT01115699|B1|Baseline|Repetitive Transcranial Magnetic Stimulation|All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
352823|NCT01115699|P1|Participant Flow|Repetitive Transcranial Magnetic Stimulation|All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
352824|NCT01115699|O1|Outcome|Repetitive Transcranial Magnetic Stimulation|All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
352825|NCT01115699|O1|Outcome|Repetitive Transcranial Magnetic Stimulation|All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
352826|NCT01115699|E1|Reported Event|Repetitive Transcranial Magnetic Stimulation|All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
352827|NCT01115673|B4|Baseline|Total|Total of all reporting groups
352828|NCT01115673|B3|Baseline|ACE-0|0 mg Acetaminophen Caplet
352829|NCT01115673|B2|Baseline|ACE-650|650 mg Acetaminophen Caplet
352830|NCT01115673|B1|Baseline|ACE-1000|1000 mg Acetaminophen Caplet
352831|NCT01115673|P3|Participant Flow|ACE-0|0 mg Acetaminophen Caplet
352832|NCT01115673|P2|Participant Flow|ACE-650|650 mg Acetaminophen Caplet
352833|NCT01115673|P1|Participant Flow|ACE-1000|1000 mg Acetaminophen Caplet
352834|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
352835|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
352836|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
352837|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
352838|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
352839|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
352840|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
352841|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
352842|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
352843|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
352844|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
352845|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
352846|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
352847|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
352848|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
352849|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
352850|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
352851|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
352852|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
352853|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
352854|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
352855|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
352856|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
352942|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
352943|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
352944|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
352945|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
352946|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
352947|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
352948|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
352949|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
352950|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
352951|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
352952|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
352953|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
352954|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
352955|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
352956|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
352957|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
352958|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
352959|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
352960|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
352961|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
352962|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
352963|NCT01115673|E3|Reported Event|ACE-0|0 mg Acetaminophen Caplet
352964|NCT01115673|E2|Reported Event|ACE-650|650 mg Acetaminophen Caplet
352965|NCT01115673|E1|Reported Event|ACE-1000|1000 mg Acetaminophen Caplet
352966|NCT01115660|B3|Baseline|Total|Total of all reporting groups
352967|NCT01115660|B2|Baseline|Control Arm|Patients received standard discharge counseling but no 2-week follow-up call.
352968|NCT01115660|B1|Baseline|Stroke Education|Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
352969|NCT01115660|P2|Participant Flow|Control Arm|Patients received standard discharge counseling but no 2-week follow-up call.
352970|NCT01115660|P1|Participant Flow|Stroke Education|Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
352971|NCT01115660|O2|Outcome|Control|standard of care
352972|NCT01115660|O1|Outcome|Stroke Education|Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
352973|NCT01115660|O2|Outcome|Control|standard of care
352974|NCT01115660|O1|Outcome|Stroke Education|Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
352975|NCT01115660|E2|Reported Event|Control Arm|Patients received standard discharge counseling but no 2-week follow-up call.
352976|NCT01115660|E1|Reported Event|Stroke Education|Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
352977|NCT01115582|B1|Baseline|Cholic Acid|All patients entered and treated
352978|NCT01115582|P1|Participant Flow|Cholic Acid|All patients entered and treated
352979|NCT01115582|O1|Outcome|Cholic Acid|All patients entered and treated
352980|NCT01115582|O1|Outcome|Cholic Acid|All patients entered and treated
352981|NCT01115582|O1|Outcome|Cholic Acid|All patients entered and treated
352982|NCT01115582|O1|Outcome|Cholic Acid|All patients entered and treated
352983|NCT01115582|O1|Outcome|Cholic Acid|All patients entered and treated
352984|NCT01115582|O1|Outcome|Cholic Acid|All patients entered and treated
352985|NCT01115582|E1|Reported Event|Cholic Acid|All patients entered and treated
352986|NCT01115569|B1|Baseline|Open-label Hydrocodone Bitartate Extended Release (HC-ER)|Conversion/Titration Phase: HC-ER capsules daily for up to 6 weeks
352987|NCT01115569|P2|Participant Flow|Open-label Hydrocodone Bitartrate Extended Release Capsules|"Maintenance HC-ER Treatment Phase: Open-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-ER in a flexible dosing regimen.~Hydrocodone Bitartrate: Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks"
352988|NCT01115569|P1|Participant Flow|Open-label Hydrocodone Bitartrate Extended Release (HC-ER)|Conversion/Titration Phase: HC-ER capsules daily for up to 6 weeks
352989|NCT01115569|O1|Outcome|Open-label Hydrocodone Bitartrate Extended Release Capsules|"Maintenance HC-ER Treatment Phase: Open-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-CR in a flexible dosing regimen.~Hydrocodone Bitartrate: Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks"
352990|NCT01115569|E2|Reported Event|Maintenance Treatment Phase|"Maintenance Hydrocodone Bitartrate Extended Release (HC-ER) Treatment Phase: Open-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-CR in a flexible dosing regimen.~Hydrocodone Bitartrate: Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks"
352991|NCT01115569|E1|Reported Event|Conversion/Titration Phase|Conversion/Titration Phase: Hydrocodone Bitartrate Extended Release (HC-ER) capsules daily for up to 6 weeks
352992|NCT01115556|B3|Baseline|Total|Total of all reporting groups
352993|NCT01115556|B2|Baseline|Lucentis 0.5 mg|Lucentis (ranibizumab) 0.5 mg
352994|NCT01115556|B1|Baseline|Lucentis 2.0 mg|Lucentis (ranibizumab) 2.0 mg
352995|NCT01115556|P2|Participant Flow|Lucentis 0.5 mg|Lucentis (ranibizumab) 0.5 mg
352996|NCT01115556|P1|Participant Flow|Lucentis 2.0 mg|Lucentis (ranibizumab) 2.0 mg
352997|NCT01115556|O2|Outcome|LUCENTIS 0.5 mg|Ranibizumab: 0.5 mg
352998|NCT01115556|O1|Outcome|Lucentis 2.0 mg|"Lucentis 2.0 mg~Ranibizumab: 2.0 mg"
352999|NCT01115556|O2|Outcome|Lucentis 0.5 mg|Lucentis (ranibizumab) 0.5 mg
353000|NCT01115556|O1|Outcome|Lucentis 2.0 mg|Lucentis (ranibizumab) 2.0 mg
353001|NCT01115556|E2|Reported Event|Lucentis 0.5 mg|Lucentis (ranibizumab) 0.5 mg
353002|NCT01115556|E1|Reported Event|Lucentis 2.0 mg|Lucentis (ranibizumab) 2.0 mg
353003|NCT01115517|B3|Baseline|Total|Total of all reporting groups
353004|NCT01115517|B2|Baseline|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
353005|NCT01115517|B1|Baseline|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
353006|NCT01115517|P2|Participant Flow|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
353007|NCT01115517|P1|Participant Flow|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
353008|NCT01115517|O2|Outcome|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
353009|NCT01115517|O1|Outcome|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
353010|NCT01115517|O2|Outcome|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
353011|NCT01115517|O1|Outcome|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
353012|NCT01115517|O2|Outcome|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
353013|NCT01115517|O1|Outcome|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
353014|NCT01115517|E2|Reported Event|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
353015|NCT01115517|E1|Reported Event|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
353016|NCT01115491|B1|Baseline|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
353017|NCT01115491|P1|Participant Flow|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 milligrams per kilogram (mg/kg) intravenously (IV) on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg per square meter (mg/m^2), orally (PO), on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
353018|NCT01115491|O1|Outcome|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
353019|NCT01115491|O1|Outcome|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
353020|NCT01115491|O1|Outcome|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
353021|NCT01115491|O1|Outcome|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
353043|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353022|NCT01115491|O1|Outcome|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
353023|NCT01115491|O1|Outcome|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
353024|NCT01115491|E1|Reported Event|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
353025|NCT01115452|B1|Baseline|Overall Study|
353026|NCT01115452|P1|Participant Flow|5% or 2.5% Potassium Nitrate Solution or Water|Investigator applied the participants with 5% potassium nitrate solution or 2.5% potassium nitrate solution or water to a single sensitive tooth for two minutes (mins), in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353027|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353028|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353029|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353030|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353031|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353032|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353033|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353034|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353035|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353036|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353037|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353038|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353039|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353040|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353041|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353042|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353132|NCT01114997|E2|Reported Event|Esmolol|Pre-Induction: Loading dose 750 mcg/Kg (0.75 mg/kg) Post-Induction: Infusion dose 7.5 - 15 mcg /kg/min
353137|NCT01114945|B2|Baseline|Video-Mac|Video-Mac device
353044|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353045|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353046|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353047|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353048|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353049|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment..
353050|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353051|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353052|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353053|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353054|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353055|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353056|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353057|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353058|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353059|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353060|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353061|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353062|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353063|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353064|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353065|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353066|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353133|NCT01114997|E1|Reported Event|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
353134|NCT01114945|B5|Baseline|Total|Total of all reporting groups
353067|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353068|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353069|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353070|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353071|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353072|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment
353073|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
353074|NCT01115452|E1|Reported Event|Overall Study|
353075|NCT01115244|B3|Baseline|Total|Total of all reporting groups
353076|NCT01115244|B2|Baseline|Not Treated|One arm of the patient will be left untreated.
353077|NCT01115244|B1|Baseline|Dapsone Gel, 5%|"ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks.~Dapsone gel, 5%: ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks."
353078|NCT01115244|P2|Participant Flow|Not Treated|One arm of the patient will be left untreated.
353079|NCT01115244|P1|Participant Flow|Dapsone Gel, 5%|"ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks.~Dapsone gel, 5%: ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks."
353080|NCT01115244|O2|Outcome|Not Treated|One arm of the patient will be left untreated.
353081|NCT01115244|O1|Outcome|Dapsone Gel, 5%|"ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks.~Dapsone gel, 5%: ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks."
353082|NCT01115244|O2|Outcome|Not Treated|One arm of the patient will be left untreated.
353083|NCT01115244|O1|Outcome|Dapsone Gel, 5%|"ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks.~Dapsone gel, 5%: ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks."
353084|NCT01115244|O2|Outcome|Not Treated|One arm of the patient will be left untreated.
353085|NCT01115244|O1|Outcome|Dapsone Gel, 5%|"ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks.~Dapsone gel, 5%: ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks."
353086|NCT01115244|E2|Reported Event|Not Treated|One arm of the patient will be left untreated.
353087|NCT01115244|E1|Reported Event|Dapsone Gel, 5%|"ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks.~Dapsone gel, 5%: ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks."
353088|NCT01115166|B1|Baseline|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
353089|NCT01115166|P1|Participant Flow|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
353090|NCT01115166|O1|Outcome|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
353091|NCT01115166|O1|Outcome|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
353092|NCT01115166|O1|Outcome|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
353093|NCT01115166|E1|Reported Event|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
353094|NCT01115101|B3|Baseline|Total|Total of all reporting groups
353095|NCT01115101|B2|Baseline|Patient Controlled Device With Pritramid|Patients assigned to the PCA group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose.
353096|NCT01115101|B1|Baseline|Oxycodon|Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after CS.
353135|NCT01114945|B4|Baseline|McGrath|MacGrath device
353097|NCT01115101|P2|Participant Flow|Patient Controlled Device With Pritramid|Patients assigned to the Patient-controlled analgesia (PCA) group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose.
353098|NCT01115101|P1|Participant Flow|Oxycodon|Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after cesarean section (CS).
353099|NCT01115101|O2|Outcome|Patient Controlled Device With Pritramid|Patients assigned to the PCA group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose.
353100|NCT01115101|O1|Outcome|Oxycodon|Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after CS.
353101|NCT01115101|E2|Reported Event|Patient Controlled Device With Pritramid|Patients assigned to the PCA group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose.
353102|NCT01115101|E1|Reported Event|Oxycodon|Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after CS.
353103|NCT01114997|B4|Baseline|Total|Total of all reporting groups
353104|NCT01114997|B3|Baseline|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-Induction (Maintenance Infusion):~Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
353105|NCT01114997|B2|Baseline|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
353106|NCT01114997|B1|Baseline|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
353107|NCT01114997|P3|Participant Flow|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
353108|NCT01114997|P2|Participant Flow|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
353109|NCT01114997|P1|Participant Flow|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg Post- Induction:Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
353110|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
353111|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
353112|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
353113|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine (12.5-25 mcg/kg/min) + Esmolol (7.5-15 mcg/kg/min)"
353114|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
353115|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
353116|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
353117|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
353118|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
353119|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
353120|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
353121|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
353122|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
353123|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
353124|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
353125|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
353126|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
353127|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
353128|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
353129|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
353130|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
353131|NCT01114997|E3|Reported Event|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
353136|NCT01114945|B3|Baseline|GlideScope|GlideScope device
353138|NCT01114945|B1|Baseline|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscope device
353139|NCT01114945|P4|Participant Flow|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscopy (DL)
353140|NCT01114945|P3|Participant Flow|McGrath|MacGrath
353141|NCT01114945|P2|Participant Flow|GlideScope|GlideScope device
353142|NCT01114945|P1|Participant Flow|Video-Mac|Video-Mac device
353143|NCT01114945|O4|Outcome|McGrath|MacGrath device
353144|NCT01114945|O3|Outcome|GlideScope|GlideScope device
353145|NCT01114945|O2|Outcome|Video-Mac|Video-Mac device
353146|NCT01114945|O1|Outcome|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscope device
353147|NCT01114945|O4|Outcome|McGrath|MacGrath device
353148|NCT01114945|O3|Outcome|GlideScope|GlideScope device
353149|NCT01114945|O2|Outcome|Video-Mac|Video-Mac device
353150|NCT01114945|O1|Outcome|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscope device
353151|NCT01114945|O4|Outcome|McGrath|MacGrath device
353152|NCT01114945|O3|Outcome|GlideScope|GlideScope device
353153|NCT01114945|O2|Outcome|Video-Mac|Video-Mac device
353154|NCT01114945|O1|Outcome|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscopy (DL)
353155|NCT01114945|O4|Outcome|McGrath|MacGrath device
353156|NCT01114945|O3|Outcome|GlideScope|GlideScope device
353157|NCT01114945|O2|Outcome|Video-Mac|Video-Mac device
353158|NCT01114945|O1|Outcome|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscopy (DL)
353159|NCT01114945|E4|Reported Event|Direct Macintosh Laryngoscopy|"Direct Macintosh Laryngoscopy (DL) used during intubation procedure~McGrath: McGrath will be compared with:~Direct Macintosh Laryngoscopy Video-Mac GlideScope~GlideScope: GlideScope will be compared with:~Direct Macintosh Laryngoscopy Video-Mac and McGrath~Video-Mac: Video-Mac will be compared with:~Direct Macintosh Laryngoscopy GlideScope and McGrath"
353160|NCT01114945|E3|Reported Event|McGrath|"McGrath device used during intubation procedure~GlideScope: GlideScope will be compared with:~Direct Macintosh Laryngoscopy Video-Mac and McGrath~Direct Macintosh Laryngoscopy: Direct Macintosh Laryngoscopy will be compared with:~GlideScope Video-Mac and McGrath~Video-Mac: Video-Mac will be compared with:~Direct Macintosh Laryngoscopy GlideScope and McGrath"
353161|NCT01114945|E2|Reported Event|GlideScope|"GlideScope device used during intubation procedure~McGrath: McGrath will be compared with:~Direct Macintosh Laryngoscopy Video-Mac GlideScope~Direct Macintosh Laryngoscopy: Direct Macintosh Laryngoscopy will be compared with:~GlideScope Video-Mac and McGrath~Video-Mac: Video-Mac will be compared with:~Direct Macintosh Laryngoscopy GlideScope and McGrath"
353162|NCT01114945|E1|Reported Event|Video-Mac|"Video-Mac device used during intubation procedure~McGrath: McGrath will be compared with:~Direct Macintosh Laryngoscopy Video-Mac GlideScope~GlideScope: GlideScope will be compared with:~Direct Macintosh Laryngoscopy Video-Mac and McGrath~Direct Macintosh Laryngoscopy: Direct Macintosh Laryngoscopy will be compared with:~GlideScope Video-Mac and McGrath"
353163|NCT01114893|B6|Baseline|Total|Total of all reporting groups
353164|NCT01114893|B5|Baseline|Travoprost Group C|Travoprost Group C
353165|NCT01114893|B4|Baseline|Travoprost Group B|Travoprost Group B
353166|NCT01114893|B3|Baseline|Travoprost Group A|Travoprost Group A
353167|NCT01114893|B2|Baseline|Travoprost Vehicle|Travoprost Vehicle
353168|NCT01114893|B1|Baseline|TRAVATAN|TRAVATAN 0.004% once daily
353169|NCT01114893|P5|Participant Flow|Travoprost Group C|Travoprost Group C
353170|NCT01114893|P4|Participant Flow|Travoprost Group B|Travoprost Group B
353171|NCT01114893|P3|Participant Flow|Travoprost Group A|Travoprost Group A
353172|NCT01114893|P2|Participant Flow|Travoprost Vehicle|Travoprost Vehicle
353173|NCT01114893|P1|Participant Flow|TRAVATAN|TRAVATAN 0.004% once daily
353174|NCT01114893|O5|Outcome|Travoprost Group C|
353175|NCT01114893|O4|Outcome|Travoprost Group B|
353176|NCT01114893|O3|Outcome|Travoprost Group A|
353177|NCT01114893|O2|Outcome|Travoprost Vehicle|
353178|NCT01114893|O1|Outcome|Travatan 0.004% QD|
353179|NCT01114893|O5|Outcome|Travoprost Group C|
353180|NCT01114893|O4|Outcome|Travoprost Group B|
353181|NCT01114893|O3|Outcome|Travoprost Group A|
353182|NCT01114893|O2|Outcome|Travoprost Vehicle|
353183|NCT01114893|O1|Outcome|Travatan 0.004% QD|
353184|NCT01114893|E5|Reported Event|Travoprost Group C|Travoprost Group C
353185|NCT01114893|E4|Reported Event|Travoprost Group B|Travoprost Group B
353186|NCT01114893|E3|Reported Event|Travoprost Group A|Travoprost Group A
353187|NCT01114893|E2|Reported Event|Travoprost Vehicle|Travoprost Vehicle
353188|NCT01114893|E1|Reported Event|TRAVATAN|TRAVATAN 0.004% once daily
353189|NCT01114880|B3|Baseline|Total|Total of all reporting groups
353190|NCT01114880|B2|Baseline|Placebo|Blinded placebo from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
353191|NCT01114880|B1|Baseline|Adalimumab|Blinded adalimumab from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
353192|NCT01114880|P2|Participant Flow|Placebo|Blinded placebo from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
353193|NCT01114880|P1|Participant Flow|Adalimumab|Blinded adalimumab from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
353194|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353195|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353196|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353197|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353198|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353199|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353200|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353201|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353202|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353203|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353204|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353205|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353206|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353207|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353208|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353209|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353210|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353211|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353212|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353213|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353214|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353215|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353216|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353217|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353218|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353219|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353220|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353221|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353222|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353223|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353224|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353225|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353226|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353227|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353228|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353229|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353230|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353231|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353232|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353233|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353234|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353235|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353236|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353237|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
353238|NCT01114880|E4|Reported Event|Placebo/Adalimumab (Period 2)|Open-label adalimumab from Week 12 to Week 22 in participants previously on blinded placebo from Week 0 to Week 10
353239|NCT01114880|E3|Reported Event|Adalimumab/Adalimumab (Period 2)|Open-label adalimumab from Week 12 to Week 22 in participants previously on blinded adalimumab from Week 0 to Week 10
353240|NCT01114880|E2|Reported Event|Placebo (Period 1)|Blinded placebo from Week 0 to Week 10
353241|NCT01114880|E1|Reported Event|Adalimumab (Period 1)|Blinded adalimumab from Week 0 to Week 10
353242|NCT01114828|B3|Baseline|Total|Total of all reporting groups
353243|NCT01114828|B2|Baseline|7.5 mg|Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
353244|NCT01114828|B1|Baseline|3.75 mg|Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
353245|NCT01114828|P2|Participant Flow|7.5 mg|Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
353246|NCT01114828|P1|Participant Flow|3.75 mg|Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
353247|NCT01114828|O2|Outcome|OPC-41061 7.5 mg|Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
353248|NCT01114828|O1|Outcome|OPC-41061 3.75 mg|Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
353249|NCT01114828|O2|Outcome|OPC-41061 7.5 mg|Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
353250|NCT01114828|O1|Outcome|OPC-41061 3.75 mg|Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
353251|NCT01114828|E2|Reported Event|7.5 mg|Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
353252|NCT01114828|E1|Reported Event|3.75 mg|Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
353253|NCT01114737|B3|Baseline|Total|Total of all reporting groups
353254|NCT01114737|B2|Baseline|6R-BH4 20 mg/kg/Day|Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact). Patient will be treated for 26 weeks, the first 13 weeks were double-blinded randomized treatment period, the second 13 weeks open label treatment period
353255|NCT01114737|B1|Baseline|Placebo|Placebo: Placebo (tablet without active ingredient) is dosed once/day for the first 13 weeks of the study(double-blinded randomized treatment period); then treated with sapropterin dihydrochloride 20 mg/kg/day for an additional 13 weeks (open label treatment period).
353256|NCT01114737|P2|Participant Flow|6R-BH4 20 mg/kg/Day|Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact). Patient will be treated for 26 weeks, the first 13 weeks were double-blinded randomized treatment period, the second 13 weeks open label treatment period
353257|NCT01114737|P1|Participant Flow|Placebo|Placebo: Placebo (tablet without active ingredient) is dosed once/day for the first 13 weeks of the study(double-blinded randomized treatment period); then treated with sapropterin dihydrochloride 20 mg/kg/day for an additional 13 weeks (open label treatment period).
353258|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
353259|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
353260|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
353261|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
353262|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
353263|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
353264|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
353265|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
353266|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
353267|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
353268|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
353269|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
353270|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm With ADHD Symptoms|Included all subjects in the 6R-BH4 20 mg/kg/day arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at baseline
353271|NCT01114737|O1|Outcome|Responders in Placebo Arm With ADHD Symptoms|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at baseline
353272|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
353273|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
353274|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
353275|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
353276|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
353277|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
353278|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
353279|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
353280|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
353385|NCT01114529|O1|Outcome|Everolimus|Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids
353281|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
353282|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm With ADHD Symptoms|Included all subjects in the 6R-BH4 20 mg/kg/day arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at baseline
353283|NCT01114737|O1|Outcome|Responders in Placebo Arm With ADHD Symptoms|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at baseline
353284|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
353285|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
353286|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
353287|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
353288|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
353289|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
353290|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
353291|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
353292|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
353293|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
353294|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm With ADHD Symptoms|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at Baseline
353295|NCT01114737|O1|Outcome|Responders in Placebo Arm With ADHD Symptoms|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at Baseline
353296|NCT01114737|E8|Reported Event|6R-BH4 Treatment Period - Combined|6R-BH4 Combined Treatments - Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact).
353297|NCT01114737|E7|Reported Event|6R-BH4 Treatment Period - 6R-BH4|6R-BH4 Treatment Period - Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact).
353298|NCT01114737|E6|Reported Event|Open-Label Treatment Period - Overall|Open-label Treatment Period - All patients
353299|NCT01114737|E5|Reported Event|Open-Label Treatment Period - 6R-BH4|Open-label Treatment Period - Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact).
353300|NCT01114737|E4|Reported Event|Open-Label Treatment Period - Placebo-6R-BH4|Open-label Treatment Period - Placebo: Placebo (tablet without active ingredient) is dosed once/day for the first 13 weeks of the study.
353301|NCT01114737|E3|Reported Event|Randomized Treatment Period - Overall|Randomized Treatment Period - All patients
353302|NCT01114737|E2|Reported Event|Randomized Treatment Period - 6R-BH4|Randomized Treatment Period - Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact).
353303|NCT01114737|E1|Reported Event|Randomized Treatment Period - Placebo|Randomized Treatment Period - Placebo: Placebo (tablet without active ingredient) is dosed once/day for the first 13 weeks of the study.
353304|NCT01114724|B1|Baseline|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
353305|NCT01114724|P1|Participant Flow|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
353306|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
353307|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
353308|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
353309|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
353310|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
353311|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
353312|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
353546|NCT01113801|P4|Participant Flow|50 mg LY2382770|50 mg LY2382770 given SC injection monthly for 12 months
353313|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
353314|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
353315|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
353316|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft will the Captivia Delivery System: All subjects will be implanted with this device
353317|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
353318|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
353319|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
353320|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
353321|NCT01114724|E1|Reported Event|1. Dissection|Medtronic Dissection
353322|NCT01114672|B3|Baseline|Total|Total of all reporting groups
353323|NCT01114672|B2|Baseline|Oral Placebo|Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
353324|NCT01114672|B1|Baseline|Ergocalciferol|Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
353325|NCT01114672|P2|Participant Flow|Oral Placebo|Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
353326|NCT01114672|P1|Participant Flow|Ergocalciferol|Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
353327|NCT01114672|O2|Outcome|Oral Placebo|Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
353328|NCT01114672|O1|Outcome|Ergocalciferol|Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
353329|NCT01114672|E2|Reported Event|Oral Placebo|Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
353330|NCT01114672|E1|Reported Event|Ergocalciferol|Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
353331|NCT01114620|B1|Baseline|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353332|NCT01114620|P1|Participant Flow|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353333|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353334|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353335|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353336|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353337|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353338|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353339|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353340|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353341|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353342|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353343|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353344|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353345|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353547|NCT01113801|P3|Participant Flow|10 mg LY2382770|10 mg LY2382770 given SC injection monthly for 12 months
353346|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353347|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353348|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353349|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353350|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353351|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353352|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353353|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353354|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353355|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353356|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353357|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353358|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353359|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353360|NCT01114620|O1|Outcome|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353361|NCT01114620|E1|Reported Event|Arepanrix Group|Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
353362|NCT01114581|B3|Baseline|Total|Total of all reporting groups
353363|NCT01114581|B2|Baseline|Placebo|Given as 2 tablets
353364|NCT01114581|B1|Baseline|Guaifenesin|Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
353365|NCT01114581|P2|Participant Flow|Placebo|Given as 2 tablets
353366|NCT01114581|P1|Participant Flow|Guaifenesin|Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
353367|NCT01114581|O2|Outcome|Placebo|Given as 2 tablets
353368|NCT01114581|O1|Outcome|Guaifenesin|Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
353369|NCT01114581|O2|Outcome|Placebo|Given as 2 tablets
353370|NCT01114581|O1|Outcome|Guaifenesin|Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
353371|NCT01114581|E2|Reported Event|Placebo|Given as 2 tablets
353372|NCT01114581|E1|Reported Event|Guaifenesin|Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
353373|NCT01114529|B4|Baseline|Total|Total of all reporting groups
353374|NCT01114529|B3|Baseline|Standard CNI (CsA)|Calcineurin inhibitor (CNI) continuation with Cyclosporine (CsA) in combination with Myfortic (mycophenolic acid) and steroids
353375|NCT01114529|B2|Baseline|Standard CNI (Tac)|Calcineurin inhibitor (CNI) continuation with Tacrolimus (Tac) in combination with Myfortic (mycophenolic acid), and steroids
353376|NCT01114529|B1|Baseline|Everolimus|Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids
353377|NCT01114529|P3|Participant Flow|Standard CNI (CsA)|Calcineurin inhibitor (CNI) continuation with Cyclosporine (CsA) in combination with Myfortic (mycophenolic acid) and steroids
353378|NCT01114529|P2|Participant Flow|Standard CNI (Tac)|Calcineurin inhibitor (CNI) continuation with Tacrolimus (Tac) in combination with Myfortic (mycophenolic acid), and steroids
353379|NCT01114529|P1|Participant Flow|Everolimus|Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids
353380|NCT01114529|O3|Outcome|Standard CNI (CsA)|Calcineurin inhibitor (CNI) continuation with Cyclosporine (CsA) in combination with Myfortic (mycophenolic acid) and steroids
353381|NCT01114529|O2|Outcome|Standard CNI (Tac)|Calcineurin inhibitor (CNI) continuation with Tacrolimus (Tac) in combination with Myfortic (mycophenolic acid), and steroids
353382|NCT01114529|O1|Outcome|Everolimus|Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids
353383|NCT01114529|O3|Outcome|Standard CNI (CsA)|Calcineurin inhibitor (CNI) continuation with Cyclosporine (CsA) in combination with Myfortic (mycophenolic acid), and steroids
353384|NCT01114529|O2|Outcome|Standard CNI (Tac)|Calcineurin inhibitor (CNI) continuation with Tacrolimus (Tac) in combination with Myfortic (mycophenolic acid) and steroids
353551|NCT01113801|O3|Outcome|10 mg LY2382770|10 mg LY2382770 given SC injection monthly for 12 months
353386|NCT01114529|O3|Outcome|Standard CNI (CsA)|Calcineurin inhibitor (CNI) continuation with Cyclosporine (CsA) in combination with Myfortic (mycophenolic acid) and steroids
353387|NCT01114529|O2|Outcome|Standard CNI (Tac)|Calcineurin inhibitor (CNI) continuation with Tacrolimus (Tac) in combination with Myfortic (mycophenolic acid), and steroids
353388|NCT01114529|O1|Outcome|Everolimus|Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids
353389|NCT01114529|O3|Outcome|Standard CNI (CsA)|Calcineurin inhibitor (CNI) continuation with Cyclosporine (CsA) in combination with Myfortic (mycophenolic acid), and steroids
353390|NCT01114529|O2|Outcome|Standard CNI (Tac)|Calcineurin inhibitor (CNI) continuation with Tacrolimus (Tac) in combination with Myfortic (mycophenolic acid) and steroids
353391|NCT01114529|O1|Outcome|Everolimus|Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids
353392|NCT01114529|E3|Reported Event|Standard CNI (CsA)|Calcineurin inhibitor (CNI) continuation with Cyclosporine (CsA) in combination with Myfortic (mycophenolic acid) and steroids
353393|NCT01114529|E2|Reported Event|Standard CNI (Tac)|Calcineurin inhibitor (CNI) continuation with Tacrolimus (Tac) in combination with Myfortic (mycophenolic acid) and steroids
353394|NCT01114529|E1|Reported Event|Everolimus|Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids
353395|NCT01114516|B3|Baseline|Total|Total of all reporting groups
353396|NCT01114516|B2|Baseline|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
353397|NCT01114516|B1|Baseline|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
353398|NCT01114516|P2|Participant Flow|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
353399|NCT01114516|P1|Participant Flow|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
353400|NCT01114516|O2|Outcome|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
353401|NCT01114516|O1|Outcome|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
353402|NCT01114516|O2|Outcome|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
353403|NCT01114516|O1|Outcome|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
353404|NCT01114516|O2|Outcome|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
353405|NCT01114516|O1|Outcome|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
353406|NCT01114516|O2|Outcome|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
353407|NCT01114516|O1|Outcome|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
353408|NCT01114516|O2|Outcome|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
353409|NCT01114516|O1|Outcome|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
353410|NCT01114516|E2|Reported Event|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
353411|NCT01114516|E1|Reported Event|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
353412|NCT01114503|B1|Baseline|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
353413|NCT01114503|P1|Participant Flow|Otelixizumab Cohort A1|Eligible participants received a total intravenous (IV) dose of otelixizumab 3.1 milligram (mg) for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 hours (h). The rate of infusion was 0.05 milligram per hour (mg/h) on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
353452|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
353453|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
353548|NCT01113801|P2|Participant Flow|2 mg LY2382770|2 milligrams (mg) LY2382770 given (SC) injection monthly for 12 months
353414|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
353415|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
353416|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
353417|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
353418|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
353419|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
353420|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
353421|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
353549|NCT01113801|P1|Participant Flow|Placebo|Placebo given subcutaneous (SC) injection monthly for 12 months
353422|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
353423|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
353424|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
353425|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
353426|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
353427|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
353428|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
353429|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
353550|NCT01113801|O4|Outcome|50 mg LY2382770|50 mg LY2382770 given SC injection monthly for 12 months
353430|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
353431|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
353432|NCT01114503|E1|Reported Event|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
353433|NCT01114438|B1|Baseline|EndoBarrier Gastrointestinal Liner|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
353434|NCT01114438|P1|Participant Flow|EndoBarrier Gastrointestinal Liner|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
353435|NCT01114438|O2|Outcome|Device at 6 Months Post-explant|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner was implanted in participants for 12 months and then removed.
353436|NCT01114438|O1|Outcome|Device at Month 12 (Explant)|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner was implanted in participants for 12 months and then removed
353437|NCT01114438|O3|Outcome|No Change in Glucose-Lowering Meds at Week 52|Subjects implanted with device for 12 Months with no change in medication at the time of device removal compared to Baseline medication levels
353438|NCT01114438|O2|Outcome|Increase in Glucose-Lowering Meds at Week 52|Subjects implanted with device for 12 Months with an Increase in medication at the time of device removal compared to Baseline medication levels
353439|NCT01114438|O1|Outcome|Decrease in Glucose-Lowering Meds|Subjects implanted with device for 12 Months with an Decrease in medication at the time of device removal compared to Baseline medication levels
353440|NCT01114438|O1|Outcome|EndoBarrier Liner Device|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
353441|NCT01114438|O1|Outcome|EndoBarrier Liner Device|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
353442|NCT01114438|E1|Reported Event|Device|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
353443|NCT01114373|B1|Baseline|All Subjects|African American subjects with mild to moderate essential hypertension received melatonin or placebo PO for the first 4 weeks then were switched to receive either placebo or melatonin PO therapy for an additional 4 weeks without any wash out period in between.
353444|NCT01114373|P2|Participant Flow|Melatonin/Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg daily of time-released melatonin at bed time for 4 weeks, followed by 24 mg of placebo at bed time for 4 week.
353445|NCT01114373|P1|Participant Flow|Placebo/Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg of placebo at bed time for 4 weeks followed by 24 mg time release melatonin at bed time for 4 weeks.
353446|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin) .
353447|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
353448|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
353449|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
353450|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
353451|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
356804|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
353454|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks(either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
353455|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
353456|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
353457|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
353458|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
353459|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
353460|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
353461|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
353462|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
353463|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
353464|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
353465|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
353466|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin).
353467|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
353468|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin) .
353469|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
353470|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
353471|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
353472|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
353473|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
353474|NCT01114373|E2|Reported Event|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin).
353475|NCT01114373|E1|Reported Event|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
353476|NCT01114360|B1|Baseline|All Participants|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg of time release melatonin or placebo for the first 4 weeks and were then switched to receive either placebo or 8mg of time release melatonin for an additional 4 weeks without any wash out period in between.
353477|NCT01114360|P2|Participant Flow|Melatonin/Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8 mg of time released melatonin at bed time for 4 weeks, followed by 8 mg of placebo at bedtime for an additional 4 weeks.
353478|NCT01114360|P1|Participant Flow|Placebo/Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg of placebo for 4 weeks first, followed by 8 mg of time-released melatonin for 4 weeks.
353504|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
353479|NCT01114360|O2|Outcome|Placebo|"African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of treatment with melatonin).~Patients were their own controls (cross over design). 40 subjects were randomized to each of the two study arms (total=40). 4 subjects did not complete the study."
353480|NCT01114360|O1|Outcome|Melatonin|"African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of treatment with placebo).~Patients were their own controls (cross over design). 40 subjects were randomized to each of the two study arms (total=40). 4 subjects did not complete the study."
353481|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg of time release melatonin or placebo for the first 4 weeks and were then switched to receive either placebo or 8mg of time release melatonin for an additional 4 weeks without any wash out period in between
353482|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg of time release melatonin or placebo for the first 4 weeks and were then switched to receive either placebo or 8mg of time release melatonin for an additional 4 weeks without any wash out period in between.
353483|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks followed by 8mg time release melatonin for 4 weeks.
353484|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks followed by 4 weeks of placebo.
353485|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after exposure to 8mg time release melatonin for 4 weeks).
353486|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of placebo) in a crossover design.
353487|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8mg time release melatonin).
353488|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
353489|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
353490|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
353491|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks ((either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
353492|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
353493|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
353494|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
353495|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
353496|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
353497|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
353498|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
353499|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
353500|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure placebo).
353501|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks either before or after 4 weeks of exposure to 8mg daily dose of time release melatonin).
353502|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after exposure to 4 weeks of placebo).
353503|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
353505|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
353506|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
353507|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
353508|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
353509|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
353510|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
353511|NCT01114360|E2|Reported Event|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
353512|NCT01114360|E1|Reported Event|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
353513|NCT01114334|B3|Baseline|Total|Total of all reporting groups
353514|NCT01114334|B2|Baseline|Standard Management of Depression|All providers randomized to either intervention or to control received a 1-hour slideshow and the “American Psychiatric Association Practice Guideline for the Treatment of Major Depressive Disorder” (APA depression guideline) (Gelenberg et al., 2010). The resources recommended antidepressant medications and psychotherapy as evidence-based treatments for depression.
353515|NCT01114334|B1|Baseline|Motivational Interviewing With Guideline-Based Management|"Intervention – MI with Standard Management of Depression The MI training approach included interactive learning for the core MI skills. An 8-hour classroom training on 7/25/09 consisted of a brief overview of MI, videos and discussion of core MI skills and “MI Spirit,” as well as skill-building practice. At the providers’ request, the research team distributed a pocket-sized, laminated treatment outline to MI trained providers for use at the point of service~To optimize treatment integrity, 4-hour refresher sessions were offered after 4 and 12 months on 11/22/09 and 7/11/10. Over the first 14 months, the assistant trainer provided feedback via email and face-to face regarding audio-taped encounters (total two to four feedbacks per provider). In these sessions, the trainer also summarized MI skills demonstrated during the encounters and listed each patient’s change talk statements. Providers were invited to respond and to choose which MI skill(s) they needed to improve."
353516|NCT01114334|P2|Participant Flow|Standard Management of Depression|All providers randomized to either intervention or to control received a 1-hour slideshow and the “American Psychiatric Association Practice Guideline for the Treatment of Major Depressive Disorder” (APA depression guideline) (Gelenberg et al., 2010). The resources recommended antidepressant medications and psychotherapy as evidence-based treatments for depression.
353517|NCT01114334|P1|Participant Flow|Motivational Interviewing With Guideline-Based Management|"Intervention – MI with Standard Management of Depression The MI training approach included interactive learning for the core MI skills. An 8-hour classroom training on 7/25/09 consisted of a brief overview of MI, videos and discussion of core MI skills and “MI Spirit,” as well as skill-building practice. At the providers’ request, the research team distributed a pocket-sized, laminated treatment outline to MI trained providers for use at the point of service~To optimize treatment integrity, 4-hour refresher sessions were offered after 4 and 12 months on 11/22/09 and 7/11/10. Over the first 14 months, the assistant trainer provided feedback via email and face-to face regarding audio-taped encounters (total two to four feedbacks per provider). In these sessions, the trainer also summarized MI skills demonstrated during the encounters and listed each patient’s change talk statements. Providers were invited to respond and to choose which MI skill(s) they needed to improve."
353518|NCT01114334|O2|Outcome|Motivational Interview With GBMM|"Motivational Interviewing for Depression combined with guideline-based medical management for depression~Manual-based GBMM training will be provided to both intervention and control physicians. A note on the patient's chart will apprise the primary care provider that the patient screened positive for moderate or more severe depressive symptoms, and has agreed to participate in the study.~Motivational Interviewing for Depression: Intervention providers receive training to utilize Motivational Interviewing to frame discussions around depression, and to improve treatment uptake and treatment adherence for depression. Primary care providers are encouraged to apply MI to a broad conceptualization of 'treatment' including specialty mental health referral, antidepressant treatment, physical activity, and to targeting contributing factors e.g. loss of job or physical health problems."
353519|NCT01114334|O1|Outcome|Guideline-based Medical Management|"Manual-based GBMM training will be provided to both intervention and control physicians. A note on the patient's chart will apprise the primary care provider that the patient screened positive for moderate or more severe depressive symptoms, and has agreed to participate in the study.~The evidence-based algorithm covers medical management of depression including indications for treatment, selection of initial therapy, starting dosages, dose escalation, switching or augmenting treatment, assessing efficacy, treatment goals and duration, a schedule of follow-up visits and referral indications"
353540|NCT01113931|E1|Reported Event|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
353541|NCT01113801|B5|Baseline|Total|Total of all reporting groups
353542|NCT01113801|B4|Baseline|50 mg LY2382770|50 mg LY2382770 given SC injection monthly for 12 months
353543|NCT01113801|B3|Baseline|10 mg LY2382770|10 mg LY2382770 given SC injection monthly for 12 months
353544|NCT01113801|B2|Baseline|2 mg LY2382770|2 milligrams (mg) LY2382770 given (SC) injection monthly for 12 months
353520|NCT01114334|O2|Outcome|Motivational Interview With GBMM|"Motivational Interviewing for Depression combined with guideline-based medical management for depression~Manual-based GBMM training will be provided to both intervention and control physicians. A note on the patient's chart will apprise the primary care provider that the patient screened positive for moderate or more severe depressive symptoms, and has agreed to participate in the study.~Motivational Interviewing for Depression: Intervention providers receive training to utilize Motivational Interviewing to frame discussions around depression, and to improve treatment uptake and treatment adherence for depression. Primary care providers are encouraged to apply MI to a broad conceptualization of 'treatment' including specialty mental health referral, antidepressant treatment, physical activity, and to targeting contributing factors e.g. loss of job or physical health problems."
353521|NCT01114334|O1|Outcome|Guideline-based Medical Management|"Manual-based GBMM training will be provided to both intervention and control physicians. A note on the patient's chart will apprise the primary care provider that the patient screened positive for moderate or more severe depressive symptoms, and has agreed to participate in the study.~The evidence-based algorithm covers medical management of depression including indications for treatment, selection of initial therapy, starting dosages, dose escalation, switching or augmenting treatment, assessing efficacy, treatment goals and duration, a schedule of follow-up visits and referral indications"
353522|NCT01114334|O2|Outcome|Motivational Interview With GBMM|"Motivational Interviews combined with guideline-based medical management for depression~Guideline-Based Medical Management: We used the Colorado Clinical Guidelines Collaborative treatment guideline for Major Depression. It recommends treatment options e.g. specialty mental health counseling, antidepressant treatment, physical activity, depending upon presenting symptoms severity and other factors. The assessor notifies the clinician at the baseline visit about the patient's PHQ-9 depressive symptom severity score.~Motivational Interviewing for Depression: Intervention providers receive training to utilize Motivational Interviewing to frame discussions around depression, and to improve treatment uptake and treatment adherence for depression. Primary care providers are encouraged to apply MI to a broad conceptualization of 'treatment' including specialty mental health referral, antidepressant treatment, physical activity, and to targeting contributing factors e.g. loss of job or"
353523|NCT01114334|O1|Outcome|Guideline-based Medical Management|"Manual-based GBMM training will be provided to both intervention and control physicians. A note on the patient's chart will apprise the primary care provider that the patient screened positive for moderate or more severe depressive symptoms, and has agreed to participate in the study.~The evidence-based algorithm covers medical management of depression including indications for treatment, selection of initial therapy, starting dosages, dose escalation, switching or augmenting treatment, assessing efficacy, treatment goals and duration, a schedule of follow-up visits and referral indications"
353524|NCT01114334|E2|Reported Event|Motivational Interview With GBMM|"Motivational Interviewing for Depression combined with guideline-based medical management for depression~Manual-based GBMM training will be provided to both intervention and control physicians. A note on the patient's chart will apprise the primary care provider that the patient screened positive for moderate or more severe depressive symptoms, and has agreed to participate in the study.~Motivational Interviewing for Depression: Intervention providers receive training to utilize Motivational Interviewing to frame discussions around depression, and to improve treatment uptake and treatment adherence for depression. Primary care providers are encouraged to apply MI to a broad conceptualization of 'treatment' including specialty mental health referral, antidepressant treatment, physical activity, and to targeting contributing factors e.g. loss of job or physical health problems."
353525|NCT01114334|E1|Reported Event|Guideline-based Medical Management|"Manual-based GBMM training will be provided to both intervention and control physicians. A note on the patient's chart will apprise the primary care provider that the patient screened positive for moderate or more severe depressive symptoms, and has agreed to participate in the study.~The evidence-based algorithm covers medical management of depression including indications for treatment, selection of initial therapy, starting dosages, dose escalation, switching or augmenting treatment, assessing efficacy, treatment goals and duration, a schedule of follow-up visits and referral indications"
353526|NCT01113931|B3|Baseline|Total|Total of all reporting groups
353527|NCT01113931|B2|Baseline|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
353528|NCT01113931|B1|Baseline|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
353529|NCT01113931|P2|Participant Flow|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
353530|NCT01113931|P1|Participant Flow|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
353531|NCT01113931|O2|Outcome|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
353532|NCT01113931|O1|Outcome|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
353533|NCT01113931|O2|Outcome|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
353534|NCT01113931|O1|Outcome|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
353535|NCT01113931|O2|Outcome|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
353536|NCT01113931|O1|Outcome|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
353537|NCT01113931|O2|Outcome|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
353538|NCT01113931|O1|Outcome|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
353539|NCT01113931|E2|Reported Event|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
353545|NCT01113801|B1|Baseline|Placebo|Placebo given subcutaneous (SC) injection monthly for 12 months
353552|NCT01113801|O2|Outcome|2 mg LY2382770|2 mg LY2382770 given (SC) injection monthly for 12 months
353553|NCT01113801|O1|Outcome|Placebo|Placebo given subcutaneous (SC) injection monthly for 12 months
353554|NCT01113801|O4|Outcome|50 mg LY2382770|50 mg LY2382770 given SC injection monthly for 12 months
353555|NCT01113801|O3|Outcome|10 mg LY2382770|10 mg LY2382770 given SC injection monthly for 12 months
353556|NCT01113801|O2|Outcome|2 mg LY2382770|2 mg LY2382770 given (SC) injection monthly for 12 months
353557|NCT01113801|O1|Outcome|Placebo|Placebo given subcutaneous (SC) injection monthly for 12 months
353558|NCT01113801|O4|Outcome|50 mg LY2382770|50 mg LY2382770 given SC injection monthly for 12 months
353559|NCT01113801|O3|Outcome|10 mg LY2382770|10 mg LY2382770 given SC injection monthly for 12 months
353560|NCT01113801|O2|Outcome|2 mg LY2382770|2 mg LY2382770 given (SC) injection monthly for 12 months
353561|NCT01113801|O1|Outcome|Placebo|Placebo given subcutaneous (SC) injection monthly for 12 months
353562|NCT01113801|O4|Outcome|50 mg LY2382770|50 mg LY2382770 given SC injection monthly for 12 months
353563|NCT01113801|O3|Outcome|10 mg LY2382770|10 mg LY2382770 given SC injection monthly for 12 months
353564|NCT01113801|O2|Outcome|2 mg LY2382770|2 mg LY2382770 given (SC) injection monthly for 12 months
353565|NCT01113801|O1|Outcome|Placebo|Placebo given subcutaneous (SC) injection monthly for 12 months
353566|NCT01113801|O4|Outcome|50 mg LY2382770|50 mg LY2382770 given SC injection monthly for 12 months
353567|NCT01113801|O3|Outcome|10 mg LY2382770|10 mg LY2382770 given SC injection monthly for 12 months
353568|NCT01113801|O2|Outcome|2 mg LY2382770|2 mg LY2382770 given (SC) injection monthly for 12 months
353569|NCT01113801|O1|Outcome|Placebo|Placebo given subcutaneous (SC) injection monthly for 12 months
353570|NCT01113801|E4|Reported Event|50 mg LY2382770|50 mg LY2382770 given SC injection monthly for 12 months
353571|NCT01113801|E3|Reported Event|10 mg LY2382770|10 mg LY2382770 given SC injection monthly for 12 months
353572|NCT01113801|E2|Reported Event|2 mg LY2382770|2 mg LY2382770 given (SC) injection monthly for 12 months
353573|NCT01113801|E1|Reported Event|Placebo|Placebo given subcutaneous (SC) injection monthly for 12 months
353574|NCT01113749|B3|Baseline|Total|Total of all reporting groups
353575|NCT01113749|B2|Baseline|Control|
353576|NCT01113749|B1|Baseline|Decision Support|Structured decision aid with prompting to share information in discussion with primary treating health care providers.
353577|NCT01113749|P2|Participant Flow|Control|
353578|NCT01113749|P1|Participant Flow|Decision Support|Structured decision aid with prompting to share information in discussion with primary treating health care providers.
353579|NCT01113749|O2|Outcome|Control|Usual care
353580|NCT01113749|O1|Outcome|Decision Support Intervention|Decision aid
353581|NCT01113749|O2|Outcome|Control|Usual care
353582|NCT01113749|O1|Outcome|Decision Support Intervention|Decision aid
353583|NCT01113749|O2|Outcome|Control|Usual care
353584|NCT01113749|O1|Outcome|Decision Support Intervention|Decision aid
353585|NCT01113749|E2|Reported Event|Control|
353586|NCT01113749|E1|Reported Event|Decisions Support Intervention|
353587|NCT01113723|B3|Baseline|Total|Total of all reporting groups
353588|NCT01113723|B2|Baseline|Fiberoptic Bronchoscope|"Fiberoptic bronchoscope~Fiberoptic bronchoscope: Fiberoptic bronchoscope device"
353589|NCT01113723|B1|Baseline|CMAC Device|"CMAC~CMAC: CMAC Device"
353590|NCT01113723|P2|Participant Flow|Fiberoptic Bronchoscope|Fiberoptic bronchoscope device: the flexible fiberoptic scope (FFS)
353591|NCT01113723|P1|Participant Flow|CMAC Device|"CMAC~CMAC: CMAC Device"
353592|NCT01113723|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic bronchoscope device: the flexible fiberoptic scope (FFS)
353593|NCT01113723|O1|Outcome|CMAC Device|CMAC: CMAC Device
353594|NCT01113723|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic bronchoscope device: the flexible fiberoptic scope (FFS)
353595|NCT01113723|O1|Outcome|CMAC Device|"CMAC~CMAC: CMAC Device"
353596|NCT01113723|O2|Outcome|Flexible Fiberoptic Scope (FFS)|the flexible fiberoptic scope (FFS) : the flexible fiberoptic scope (FFS)
353597|NCT01113723|O1|Outcome|CMAC Device|CMAC: CMAC Device
353598|NCT01113723|E2|Reported Event|Flexible Fiberoptic Scope (FFS)|the flexible fiberoptic scope (FFS) the flexible fiberoptic scope (FFS) : the flexible fiberoptic scope (FFS)
353599|NCT01113723|E1|Reported Event|CMAC Device|"CMAC~CMAC: CMAC Device"
353600|NCT01113710|B1|Baseline|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
353601|NCT01113710|P1|Participant Flow|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
353602|NCT01113710|O1|Outcome|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
353603|NCT01113710|O1|Outcome|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
353604|NCT01113710|O1|Outcome|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
353605|NCT01113710|O1|Outcome|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
353606|NCT01113710|O1|Outcome|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
353607|NCT01113710|O1|Outcome|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
353608|NCT01113710|E1|Reported Event|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
353609|NCT01113632|B3|Baseline|Total|Total of all reporting groups
353610|NCT01113632|B2|Baseline|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
353611|NCT01113632|B1|Baseline|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
353612|NCT01113632|P2|Participant Flow|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
353613|NCT01113632|P1|Participant Flow|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
353614|NCT01113632|O2|Outcome|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
353615|NCT01113632|O1|Outcome|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg."
353616|NCT01113632|O2|Outcome|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
353617|NCT01113632|O1|Outcome|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg."
353618|NCT01113632|O2|Outcome|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
353619|NCT01113632|O1|Outcome|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg."
353620|NCT01113632|O2|Outcome|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
353621|NCT01113632|O1|Outcome|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg."
353622|NCT01113632|O2|Outcome|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
353662|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353623|NCT01113632|O1|Outcome|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg."
353624|NCT01113632|E2|Reported Event|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
353625|NCT01113632|E1|Reported Event|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
353626|NCT01113580|B3|Baseline|Total|Total of all reporting groups
353627|NCT01113580|B2|Baseline|Older Adults|Healthy volunteers aged 60 years or older
353628|NCT01113580|B1|Baseline|Adults|Healthy volunteers aged 18 to 59 years
353629|NCT01113580|P2|Participant Flow|Older Adults|Healthy volunteers aged 60 years or older
353630|NCT01113580|P1|Participant Flow|Adults|Healthy volunteers aged 18 to 59 years
353631|NCT01113580|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
353632|NCT01113580|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
353633|NCT01113580|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
353634|NCT01113580|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
353635|NCT01113580|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
353636|NCT01113580|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
353637|NCT01113580|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
353638|NCT01113580|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
353639|NCT01113580|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
353640|NCT01113580|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
353641|NCT01113580|E2|Reported Event|Older Adults|Healthy volunteers aged 60 years or older
353642|NCT01113580|E1|Reported Event|Adults|Healthy volunteers aged 18 to 59 years
353643|NCT01113541|B1|Baseline|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353644|NCT01113541|P1|Participant Flow|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353645|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353646|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353647|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353648|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353649|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353650|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353651|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353652|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353653|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353654|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353655|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353656|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353657|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353658|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353659|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353660|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353661|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353663|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353664|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353665|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353666|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353667|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353668|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353669|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353670|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353671|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353672|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353673|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353674|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353675|NCT01113541|E1|Reported Event|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
353676|NCT01113463|B1|Baseline|TPI 287|TPI 287: Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
353677|NCT01113463|P1|Participant Flow|TPI 287|TPI 287: Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
353678|NCT01113463|O1|Outcome|TPI 287|TPI 287: Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
353679|NCT01113463|O1|Outcome|TPI 287|TPI 287: Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
353680|NCT01113463|E1|Reported Event|TPI 287|TPI 287: Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
353681|NCT01113398|B1|Baseline|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.~AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.~Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
353682|NCT01113398|P1|Participant Flow|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.~AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.~Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
353683|NCT01113398|O1|Outcome|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.~AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.~Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
353684|NCT01113398|O1|Outcome|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.~AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.~Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
353685|NCT01113398|O1|Outcome|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.~AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.~Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
353686|NCT01113398|O1|Outcome|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.~AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.~Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
353710|NCT01112917|O1|Outcome|VenaTech Convertible Filter - Converted Filters|"VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism~Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration."
356805|NCT01104584|O1|Outcome|CMRM vs UMRM|
353687|NCT01113398|E1|Reported Event|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.~AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.~Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
353688|NCT01113385|B1|Baseline|Galactose|"Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.~D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally."
353689|NCT01113385|P1|Participant Flow|Galactose|"Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.~D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally."
353690|NCT01113385|O1|Outcome|Galactose|"Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.~D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally."
353691|NCT01113385|O1|Outcome|Galactose|"Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.~D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally."
353692|NCT01113385|E1|Reported Event|Galactose|"Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.~D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally."
353693|NCT01113008|B3|Baseline|Total|Total of all reporting groups
353694|NCT01113008|B2|Baseline|Control Group|Control group: In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
353695|NCT01113008|B1|Baseline|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)~Remote ischemic postconditioning: Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
353696|NCT01113008|P2|Participant Flow|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)~Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
353697|NCT01113008|P1|Participant Flow|Control Group|Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
353698|NCT01113008|O2|Outcome|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)~Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
353699|NCT01113008|O1|Outcome|Control Group|Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
353700|NCT01113008|O2|Outcome|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)~Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
353701|NCT01113008|O1|Outcome|Control Group|Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
353702|NCT01113008|O2|Outcome|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)~Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
353703|NCT01113008|O1|Outcome|Control Group|Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
353704|NCT01113008|E2|Reported Event|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)~Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
353705|NCT01113008|E1|Reported Event|Control Group|Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
353706|NCT01112917|B1|Baseline|VenaTech Convertible Filter|"VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism~Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration."
353707|NCT01112917|P2|Participant Flow|VenaTech Convertible Filter - Permanent Filtration|VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism
353708|NCT01112917|P1|Participant Flow|VenaTech Convertible Filter - Converted Filter|"VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism~Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration."
353709|NCT01112917|O1|Outcome|VenaTech Convertible Filter - Converted Filters|"VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism~Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration."
353711|NCT01112917|E1|Reported Event|VenaTech Convertible Filter|"VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism~Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration."
353712|NCT01112865|B1|Baseline|Entire Study Population|Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
353713|NCT01112865|P2|Participant Flow|Genotropin® Pen Then Mark VII Pen|Participant (not caregiver) used current Genotropin® pen (subcutaneous injections daily for 2 months) then the Mark VII pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
353714|NCT01112865|P1|Participant Flow|Mark VII Pen Then Genotropin® Pen|Participant (not caregiver) used Mark VII pen (subcutaneous injections daily for 2 months) then the current Genotropin® pen (subcutaneous injections daily for 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin recombinant deoxyribonucleic acid [rDNA] origin); doses received by participants based on body weight.
353715|NCT01112865|O2|Outcome|Genotropin® Pen|Participants who used the current Genotropin® pen (subcutaneous injections daily for 2 months) anytime during the study. Pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
353716|NCT01112865|O1|Outcome|Mark VII Pen|Participants who used the Mark VII pen (subcutaneous injections daily for 2 months) any time during the study. Pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin recombinant deoxyribonucleic acid [rDNA] origin); doses received by participants based on body weight.
353717|NCT01112865|O1|Outcome|Entire Study Population|Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
353718|NCT01112865|O1|Outcome|Entire Study Population|Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
353719|NCT01112865|O1|Outcome|Entire Study Population|Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
353720|NCT01112865|O1|Outcome|Entire Study Population|Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
353721|NCT01112865|O1|Outcome|Entire Study Population|Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
353722|NCT01112865|E1|Reported Event|Safety Population|All randomized participants who used a study pen (Genotropin® pen or the new Mark VII injection pen) at least once to administer Genotropin.
353723|NCT01112696|B1|Baseline|Group 1|Sensor Users (All Subjects)
353724|NCT01112696|P1|Participant Flow|Group 1|Sensor Users (All Subjects)
353725|NCT01112696|O1|Outcome|Sensor|"All subjects that wear sensors (all subjects)~Sensor wear: All subjects to wear sensors"
353726|NCT01112696|O1|Outcome|All Completed Subjects|All subjects that completed the frequent blood sampling procedure
353727|NCT01112696|E1|Reported Event|Group 1|Sensor Users (All Subjects)
353728|NCT01112683|B3|Baseline|Total|Total of all reporting groups
353729|NCT01112683|B2|Baseline|Placebo|These are identically-looking pills to the ones in the Memantine Arm
353730|NCT01112683|B1|Baseline|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
353731|NCT01112683|P2|Participant Flow|Placebo|These are identically-looking pills to the ones in the Memantine Arm
353732|NCT01112683|P1|Participant Flow|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
353733|NCT01112683|O2|Outcome|Placebo|These are identically-looking pills to the ones in the Memantine Arm
353734|NCT01112683|O1|Outcome|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
353735|NCT01112683|O2|Outcome|Placebo|These are identically-looking pills to the ones in the Memantine Arm
353736|NCT01112683|O1|Outcome|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
353737|NCT01112683|O2|Outcome|Placebo|These are identically-looking pills to the ones in the Memantine Arm
353738|NCT01112683|O1|Outcome|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
353739|NCT01112683|E2|Reported Event|Placebo|These are identically-looking pills to the ones in the Memantine Arm
353740|NCT01112683|E1|Reported Event|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
353741|NCT01112670|B1|Baseline|Overall Study Population|All participants who participated in at least one period of the study (n=33)
353742|NCT01112670|P6|Participant Flow|ABCB1 Group 3*|ABCB1 TTT/TTT genetic make-up. Sitagliptin+Atorvastatin to Sitagliptin. 5 participants started. 5 participants completed.
353743|NCT01112670|P5|Participant Flow|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up. Sitagliptin to Sitagliptin+Atorvastatin. 6 participants started. 5 participants completed.
353744|NCT01112670|P4|Participant Flow|ABCB1 Group 2*|ABCB1 CGC/TTT genetic make-up. Sitagliptin+Atorvastatin to Sitagiptin. 4 participants started. 4 participants completed.
353745|NCT01112670|P3|Participant Flow|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up. Sitagliptin to Sitagliptin+Atorvastatin. 7 participants started. 6 participants completed.
353746|NCT01112670|P2|Participant Flow|ABCB1 Group 1*|ABCB1 CGC/CGC genetic make-up. Sitagliptin+Atorvastatin to Sitagliptin. 3 participants started. 3 participants completed.
353747|NCT01112670|P1|Participant Flow|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up. Sitagliptin to Sitagliptin+Atorvastatin. 8 participants started. 7 participants completed.
353748|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
353749|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
353750|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
353751|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
353752|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
353753|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
353754|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
353755|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
353756|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
353757|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
353758|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
353759|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
353760|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
353761|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
353762|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
353763|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
353764|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
353765|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
353766|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
353767|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
353768|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
353769|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
353770|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/CGC genetic make-up
353771|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
353772|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
353773|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
353774|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
353775|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
353776|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
353777|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
353778|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
353779|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
353780|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
353781|NCT01112670|E1|Reported Event|Overall Study Population|All participants who started the study (n=33)
353782|NCT01112579|B3|Baseline|Total|Total of all reporting groups
353783|NCT01112579|B2|Baseline|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
353784|NCT01112579|B1|Baseline|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
353785|NCT01112579|P2|Participant Flow|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
353786|NCT01112579|P1|Participant Flow|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
353787|NCT01112579|O2|Outcome|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
353788|NCT01112579|O1|Outcome|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
353789|NCT01112579|O2|Outcome|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
353790|NCT01112579|O1|Outcome|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
353791|NCT01112579|O2|Outcome|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
353792|NCT01112579|O1|Outcome|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
353793|NCT01112579|E2|Reported Event|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
353794|NCT01112579|E1|Reported Event|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
353795|NCT01112514|B1|Baseline|ICG Injection|Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy.
353796|NCT01112514|P1|Participant Flow|ICG Injection|Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy.
353797|NCT01112514|O1|Outcome|ICG Injection|Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy.
353798|NCT01112514|E1|Reported Event|ICG Injection|Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy.
353799|NCT01112267|B3|Baseline|Total|Total of all reporting groups
353800|NCT01112267|B2|Baseline|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
353801|NCT01112267|B1|Baseline|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
353802|NCT01112267|P2|Participant Flow|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
354592|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
353803|NCT01112267|P1|Participant Flow|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
353804|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
353805|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
353806|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
353807|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
353808|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
353809|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
353810|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
353811|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
353812|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
353813|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
353814|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
353815|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
353816|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
353817|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
353818|NCT01112267|E2|Reported Event|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
353819|NCT01112267|E1|Reported Event|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
353820|NCT01112241|B1|Baseline|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
353821|NCT01112241|P1|Participant Flow|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
353822|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
353823|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
353857|NCT01111851|O2|Outcome|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
354708|NCT01108809|E1|Reported Event|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
353824|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
353825|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
353826|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
353827|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
353828|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
353829|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
353830|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
353831|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
353832|NCT01112241|E1|Reported Event|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
353833|NCT01112059|B3|Baseline|Total|Total of all reporting groups
353834|NCT01112059|B2|Baseline|Doxycycline|Doxycycline: 100 mg twice a day for 8 days
353835|NCT01112059|B1|Baseline|Placebo|placebo: placebo
353836|NCT01112059|P2|Participant Flow|Doxycycline|Doxycycline: 100 mg twice a day for 8 days
353837|NCT01112059|P1|Participant Flow|Placebo|placebo: placebo
353838|NCT01112059|O2|Outcome|Doxycycline|Doxycycline: 100 mg twice a day for 8 days
353839|NCT01112059|O1|Outcome|Placebo|placebo for 8 days
353840|NCT01112059|O2|Outcome|Doxycycline|Doxycycline: 100 mg twice a day for 8 days
353841|NCT01112059|O1|Outcome|Placebo|placebo for 8 days
353842|NCT01112059|O2|Outcome|Placebo|placebo for 8 days
353843|NCT01112059|O1|Outcome|Doxycycline|Doxycycline: 100 mg twice a day for 8 days
353844|NCT01112059|O2|Outcome|Doxycycline|Doxycycline: 100 mg twice a day for 8 days
353845|NCT01112059|O1|Outcome|Placebo|"placebo: placebo~No SAEs noted in this group, 4 total AEs recorded."
353846|NCT01112059|E2|Reported Event|Doxycycline|Doxycycline: 100 mg twice a day for 8 days
353847|NCT01112059|E1|Reported Event|Placebo|placebo: placebo
353848|NCT01111851|B3|Baseline|Total|Total of all reporting groups
353849|NCT01111851|B2|Baseline|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
353850|NCT01111851|B1|Baseline|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
353851|NCT01111851|P2|Participant Flow|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
353852|NCT01111851|P1|Participant Flow|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
353853|NCT01111851|O2|Outcome|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
353854|NCT01111851|O1|Outcome|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
353855|NCT01111851|O2|Outcome|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
353856|NCT01111851|O1|Outcome|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
354709|NCT01108796|B5|Baseline|Total|Total of all reporting groups
353858|NCT01111851|O1|Outcome|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
353859|NCT01111851|O2|Outcome|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
353860|NCT01111851|O1|Outcome|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
353861|NCT01111851|E2|Reported Event|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
353862|NCT01111851|E1|Reported Event|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
353863|NCT01111838|B1|Baseline|Patients With Refractory Metastatic Colorectal Cancer|Clinical and Translational Study of STA-9090 in Patients with Refractory Metastatic Colorectal Cancer
353864|NCT01111838|P1|Participant Flow|Patients With Refractory Metastatic Colorectal Cancer|Clinical and Translational Study of STA-9090 in Patients with Refractory Metastatic Colorectal Cancer
353865|NCT01111838|O1|Outcome|Patients With Refractory Metastatic Colorectal Cancer|Clinical and Translational Study of STA-9090 in Patients with Refractory Metastatic Colorectal Cancer
353866|NCT01111838|E1|Reported Event|Patients With Refractory Metastatic Colorectal Cancer|Clinical and Translational Study of STA-9090 in Patients with Refractory Metastatic Colorectal Cancer
353867|NCT01111825|B5|Baseline|Total|Total of all reporting groups
353868|NCT01111825|B4|Baseline|Phase 2 HER2+ Dose Esc|Phase 2, HER2 - Positive cohort with dose escalation
353869|NCT01111825|B3|Baseline|Phase 2 HER2+|Phase 2, HER2 - Amplified (HER2-Positive) cohort
353870|NCT01111825|B2|Baseline|Phase 2 Triple -ve|Phase 2, Triple - Negative cohort
353871|NCT01111825|B1|Baseline|Phase 1|Phase I, HER - Amplified (HER2-Positive) cohort
353872|NCT01111825|P4|Participant Flow|Phase 2 HER2+ Dose Esc|Phase 2, HER2 - Positive cohort with dose escalation
353873|NCT01111825|P3|Participant Flow|Phase 2 HER2+|Phase 2, HER2 - Amplified (HER2-Positive) cohort
353874|NCT01111825|P2|Participant Flow|Phase 2 Triple -ve|Phase 2, Triple - Negative cohort
353875|NCT01111825|P1|Participant Flow|Phase 1|Phase I, HER - Amplified (HER2-Positive) cohort
353876|NCT01111825|O1|Outcome|Phase 2 HER2+ Dose Esc|Phase 2, HER2 - Positive cohort with dose escalation
353877|NCT01111825|O3|Outcome|Phase 2 HER2+ Dose Esc|Phase 2, HER2 - Positive cohort with dose escalation
353878|NCT01111825|O2|Outcome|Phase 2 HER2+|Phase 2, HER2 - Amplified (HER2-Positive) cohort
353879|NCT01111825|O1|Outcome|Phase 2 Triple -ve|Phase 2, Triple - Negative cohort
353880|NCT01111825|O3|Outcome|Phase 2 HER2+ Dose Esc|Phase 2, HER2 - Positive cohort with dose escalation
353881|NCT01111825|O2|Outcome|Phase 2 HER2+|Phase 2, HER2 - Amplified (HER2-Positive) cohort
353882|NCT01111825|O1|Outcome|Phase 2 Triple -ve|Phase 2, Triple - Negative cohort
353883|NCT01111825|O3|Outcome|Phase 2 HER2+ Dose Esc|Phase 2, HER2 - Positive cohort with dose escalation
353884|NCT01111825|O2|Outcome|Phase 2 HER2+|Phase 2, HER2 - Amplified (HER2-Positive) cohort
353885|NCT01111825|O1|Outcome|Phase 2 Triple -ve|Phase 2, Triple - Negative cohort
353886|NCT01111825|O3|Outcome|Phase 2 HER2+ Dose Esc|Phase 2, HER2 - Positive cohort with dose escalation
353887|NCT01111825|O2|Outcome|Phase 2 HER2+|Phase 2, HER2 - Amplified (HER2-Positive) cohort
353888|NCT01111825|O1|Outcome|Phase 2 Triple -ve|Phase 2, Triple - Negative cohort
353889|NCT01111825|E4|Reported Event|Phase 2 HER2+ Dose Esc|Phase 2, HER2 - Positive cohort with dose escalation
353890|NCT01111825|E3|Reported Event|Phase 2 HER2+|Phase 2, HER2 - Amplified (HER2-Positive) cohort
353891|NCT01111825|E2|Reported Event|Phase 2 Triple -ve|Phase 2, Triple - Negative cohort
353892|NCT01111825|E1|Reported Event|Phase 1|Phase I, HER - Amplified (HER2-Positive) cohort
353893|NCT01111526|B1|Baseline|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
353894|NCT01111526|P3|Participant Flow|Phase II Participants Treated at MTD|All participants enrolled during Phase II.
353895|NCT01111526|P2|Participant Flow|Phase I Participants Evaluable for MTD|Participants treated after the formulation change.
353896|NCT01111526|P1|Participant Flow|Phase I Participants Not Evaluable for MTD|Participants who began treatment before the formulation change.
353897|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
353898|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
353899|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
353900|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
353901|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
353902|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
353903|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
353904|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
353905|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
353941|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353906|NCT01111526|E1|Reported Event|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
353907|NCT01111461|B1|Baseline|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
353908|NCT01111461|P1|Participant Flow|Lenvatinib 24 mg|Lenvatinib hard capsules, 24 mg (two 10-mg capsules and one 4-mg capsule) were self-administered orally once a day in the morning (without regard to food intake) in 28-day cycles. Dose reduction or interruption was allowed for participants who experienced lenvatinib-related toxicity.
353909|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
353910|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
353911|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
353912|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
353913|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
353914|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
353915|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
353916|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
353917|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
353918|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
353919|NCT01111461|E1|Reported Event|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
353920|NCT01111370|B1|Baseline|Continuous Glucose Monitoring System|The Dexcom G4 Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons with diabetes. The system is intended for single patient use and requires a prescription.
353921|NCT01111370|P1|Participant Flow|Continuous Glucose Monitoring System|DexCom™ G4 Continuous Glucose Monitoring System : Continuous Glucose Monitoring System, that is a glucose monitoring device indicated for detecting trends and tracking patterns in persons with diabetes. The system is intended for single patient use and requires a prescription.
353922|NCT01111370|O1|Outcome|CGM Device|DexCom™ G4 Continuous Glucose Monitoring System
353923|NCT01111370|E1|Reported Event|Real Time Continuous Glucose Monitoring System|"continuous glucose monitoring system~DexCom™ G4 Continuous Glucose Monitoring System: Continuous Glucose Monitoring System"
353924|NCT01111331|B1|Baseline|Study Overall|"Total number of patients randomised and treated in the study. This was a randomised, cross-over, open-label trial consisting of three treatments. 18 patients were randomised to one of two possible treatment sequences. The three treatments were~Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5~Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1~Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1"
353925|NCT01111331|P2|Participant Flow|Warfarin / Empa / Empa Plus Warfarin|"Patients received three treatments in the following order~Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1~Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5~Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1~There was a washout period of at least 14 days between the first and second treatment periods."
353926|NCT01111331|P1|Participant Flow|Empa / Empa Plus Warfarin / Warfarin|"Patients received three treatments in the following order~Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5~Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1~Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1~There was a washout period of at least 14 days between the second and third treatment periods."
353927|NCT01111331|O3|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353928|NCT01111331|O2|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353929|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
353930|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353931|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353932|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353933|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353934|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353935|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353936|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353937|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353938|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353939|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353940|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353942|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353943|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353944|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353945|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353946|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353947|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353948|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353949|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353950|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353951|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353952|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353953|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353954|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353955|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353956|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353957|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353958|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353959|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353960|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353961|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353962|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353963|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353964|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353965|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353966|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353967|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353968|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353969|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353970|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353971|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353972|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353973|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353974|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353975|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
353976|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353977|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
353978|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353979|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
353980|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353981|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
353982|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353983|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
356806|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
353984|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353985|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
353986|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353987|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
353988|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353989|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353990|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353991|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353992|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353993|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353994|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353995|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
353996|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353997|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
353998|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
353999|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
354000|NCT01111331|E3|Reported Event|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
354001|NCT01111331|E2|Reported Event|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
354002|NCT01111331|E1|Reported Event|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
354003|NCT01111318|B5|Baseline|Total|Total of all reporting groups
354004|NCT01111318|B4|Baseline|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
354005|NCT01111318|B3|Baseline|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
354006|NCT01111318|B2|Baseline|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
354007|NCT01111318|B1|Baseline|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
354008|NCT01111318|P4|Participant Flow|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
354009|NCT01111318|P3|Participant Flow|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
354010|NCT01111318|P2|Participant Flow|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
354011|NCT01111318|P1|Participant Flow|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
354012|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
354013|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
354014|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
354015|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
354016|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
354017|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
354018|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
354019|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
354020|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
354710|NCT01108796|B4|Baseline|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
354021|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
354022|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
354023|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
354024|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
354025|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
354026|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
354027|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
354028|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
354029|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
354030|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
354031|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
354032|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
354033|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
354034|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
354035|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
354036|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
354037|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
354038|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
354039|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
354040|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
354041|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
354042|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
354043|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
354044|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
354045|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
354046|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
354047|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
354048|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
354049|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
354050|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
354051|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
354052|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
356807|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
354053|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
354054|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
354055|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
354056|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
354057|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
354058|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
354059|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
354060|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
354061|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
354062|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
354063|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
354064|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
354065|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
354066|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
354067|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
354068|NCT01111318|E4|Reported Event|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
354069|NCT01111318|E3|Reported Event|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
354070|NCT01111318|E2|Reported Event|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
354071|NCT01111318|E1|Reported Event|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
354072|NCT01111305|B3|Baseline|Total|Total of all reporting groups
354073|NCT01111305|B2|Baseline|Placebo|"Placebo~Diethylcarbamazine"
354074|NCT01111305|B1|Baseline|Reslizumab|"Reslizumab~Diethylcarbamazine"
354075|NCT01111305|P2|Participant Flow|Placebo|"Placebo~Diethylcarbamazine"
354076|NCT01111305|P1|Participant Flow|Reslizumab|"Reslizumab~Diethylcarbamazine"
354077|NCT01111305|O2|Outcome|Placebo|"Placebo~Diethylcarbamazine"
354078|NCT01111305|O1|Outcome|Reslizumab|"Reslizumab~Diethylcarbamazine"
354079|NCT01111305|O2|Outcome|Placebo + DEC|"Placebo iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days~Diethylcarbamazine~Placebo"
354080|NCT01111305|O1|Outcome|Reslizumab + DEC|"Reslizumab 1 mg/kg iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days~Reslizumab~Diethylcarbamazine"
354081|NCT01111305|O2|Outcome|Placebo + DEC|"Placebo iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days~Diethylcarbamazine~Placebo"
354082|NCT01111305|O1|Outcome|Reslizumab + DEC|"Reslizumab 1 mg/kg iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days~Reslizumab~Diethylcarbamazine"
354083|NCT01111305|E2|Reported Event|Placebo + DEC|"Placebo iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days~Diethylcarbamazine~Placebo"
354084|NCT01111305|E1|Reported Event|Reslizumab + DEC|"Reslizumab 1 mg/kg iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days~Reslizumab~Diethylcarbamazine"
354085|NCT01111292|B3|Baseline|Total|Total of all reporting groups
354086|NCT01111292|B2|Baseline|Arm II (Placebo)|"Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
354087|NCT01111292|B1|Baseline|Arm I (Inositol)|"Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90.~Inositol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
354088|NCT01111292|P2|Participant Flow|Arm II (Placebo)|"Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
354089|NCT01111292|P1|Participant Flow|Arm I (Inositol)|"Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90.~Inositol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
354090|NCT01111292|O2|Outcome|Arm II (Placebo)|"Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
354091|NCT01111292|O1|Outcome|Arm I (Inositol)|"Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90.~Inositol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
354092|NCT01111292|E2|Reported Event|Arm II (Placebo)|"Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
354093|NCT01111292|E1|Reported Event|Arm I (Inositol)|"Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90.~Inositol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
354094|NCT01111240|B1|Baseline|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
354095|NCT01111240|P1|Participant Flow|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
354096|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
354097|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
354098|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
354099|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
354100|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
354101|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
354102|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
354103|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
354104|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
354105|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
354106|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
354107|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
354108|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
354109|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
354110|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
354111|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
354112|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
354113|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
354114|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
354115|NCT01111240|E1|Reported Event|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
354116|NCT01111162|B1|Baseline|Vaccination Group (Single Arm Study)|All participants
354117|NCT01111162|P1|Participant Flow|Vaccine Arm (Single Arm)|15 µg dose of the monovalent, unadjuvanted, inactivated, split virus H1N1 vaccine (Novartis, Basel, Switzerland).
354118|NCT01111162|O1|Outcome|Vaccine Arm (Single Arm)|15 µg dose of the monovalent, unadjuvanted, inactivated, split virus H1N1 vaccine (Novartis, Basel, Switzerland).
354119|NCT01111162|O1|Outcome|Vacinees|
354120|NCT01111162|E1|Reported Event|Vaccine Arm (Single Arm)|15 µg dose of the monovalent, unadjuvanted, inactivated, split virus H1N1 vaccine (Novartis, Basel, Switzerland).
354121|NCT01111149|B4|Baseline|Total|Total of all reporting groups
354122|NCT01111149|B3|Baseline|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
354123|NCT01111149|B2|Baseline|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
354124|NCT01111149|B1|Baseline|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
354125|NCT01111149|P3|Participant Flow|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
354126|NCT01111149|P2|Participant Flow|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
354127|NCT01111149|P1|Participant Flow|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
354128|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
354129|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
354130|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
354131|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
354132|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
354133|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
354134|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
354135|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
354136|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
354137|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
354138|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
354139|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
354140|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
354141|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
354142|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
354143|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
354144|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
354145|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
354146|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
354147|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
354148|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
354149|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
354150|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
354151|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
354152|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
354153|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
354154|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
354155|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
354156|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
354157|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
354158|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
354236|NCT01110915|B2|Baseline|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
354159|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
354160|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
354161|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
354162|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
354163|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
354164|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
354165|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
354166|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
354167|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
354168|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
354169|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
354170|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
354171|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
354172|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
354173|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
354174|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
354175|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
354478|NCT01109979|E2|Reported Event|E+DRSP|Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks
354176|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
354177|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
354178|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
354179|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
354180|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
354181|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
354182|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
354183|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
354184|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
354185|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
354186|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
354187|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
354188|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
354189|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
354190|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
354191|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
354192|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
354193|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
354194|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
354195|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
354196|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
354197|NCT01111149|E3|Reported Event|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
354198|NCT01111149|E2|Reported Event|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
354199|NCT01111149|E1|Reported Event|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
354200|NCT01111123|B3|Baseline|Total|Total of all reporting groups
354201|NCT01111123|B2|Baseline|Lac Hydrin + Placebo|Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only, for up to 24 weeks
354202|NCT01111123|B1|Baseline|Lac-hydrin + Ultravate|Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only, for up to 24 weeks
354203|NCT01111123|P2|Participant Flow|Lac Hydrin + Placebo|Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only, for up to 24 weeks
354204|NCT01111123|P1|Participant Flow|Lac-hydrin + Ultravate|Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only, for up to 24 weeks
354205|NCT01111123|O2|Outcome|Lac-hydrin + Placebo|lac hydrin twice daily everyday plus placebo ointment twice daily weekends only
354206|NCT01111123|O1|Outcome|Lac-hydrin + Ultravate|ammonium lactate twice daily everyday + ultravate twice daily weekends only
354207|NCT01111123|O2|Outcome|Ammoium Lactate + Placebo|ammonium lactate twice daily everyday plus placebo ointment twice daily weekends only
354208|NCT01111123|O1|Outcome|Ammonium Lactate + Ultravate|ammonium lactate twice daily everyday plus ultravte ointment twice daily on weekends only for up to 24 weeks
354209|NCT01111123|E2|Reported Event|Lac Hydrin + Placebo|Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only, for up to 24 weeks
354210|NCT01111123|E1|Reported Event|Lac-hydrin + Ultravate|Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only, for up to 24 weeks
354211|NCT01111110|B3|Baseline|Total|Total of all reporting groups
354212|NCT01111110|B2|Baseline|Static/Antistatic|albuterol with static chamber then with antistatic chamber on another night.
354213|NCT01111110|B1|Baseline|Anti-static/Static|albuterol with anti-static chamber then Static on another night
354214|NCT01111110|P2|Participant Flow|Static/Antistatic|albuterol with static chamber then with antistatic chamber on another night.
354215|NCT01111110|P1|Participant Flow|Anti-static/Static|albuterol with anti-static chamber then Static on another night
354216|NCT01111110|O2|Outcome|Static/Antistatic|albuterol with static chamber then with antistatic chamber on another night.
354217|NCT01111110|O1|Outcome|Anti-static/Static|albuterol with anti-static chamber then Static on another night
354218|NCT01111110|O2|Outcome|Static/Antistatic|albuterol with static chamber then with antistatic chamber on another night.
354219|NCT01111110|O1|Outcome|Anti-static/Static|albuterol with anti-static chamber then Static on another night
354220|NCT01111110|O2|Outcome|Static/Antistatic|albuterol with static chamber then with antistatic chamber on another night.
354221|NCT01111110|O1|Outcome|Anti-static/Static|albuterol with anti-static chamber then Static on another night
354222|NCT01111110|E2|Reported Event|Antistatic|albuterol with antistatic chamber.
354223|NCT01111110|E1|Reported Event|Static|albuterol with static chamber
354224|NCT01110967|B1|Baseline|Patients Implanted With a Satellite Device|
354225|NCT01110967|P1|Participant Flow|Patients Implanted With a Satellite Device|
354226|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
354227|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
354228|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
354229|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
354230|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
354231|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
354232|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
354233|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
354234|NCT01110967|E1|Reported Event|Patients Implanted With a Satellite Device|
354235|NCT01110915|B3|Baseline|Total|Total of all reporting groups
354237|NCT01110915|B1|Baseline|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
354238|NCT01110915|P2|Participant Flow|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
354239|NCT01110915|P1|Participant Flow|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
354240|NCT01110915|O1|Outcome|Implanted Subjects|Any subject who underwent a successful implant of the Advisa MRI system.
354241|NCT01110915|O1|Outcome|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
354242|NCT01110915|O2|Outcome|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
354243|NCT01110915|O1|Outcome|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
354244|NCT01110915|O2|Outcome|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
354245|NCT01110915|O1|Outcome|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
354246|NCT01110915|O2|Outcome|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
354247|NCT01110915|O1|Outcome|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
354248|NCT01110915|O2|Outcome|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
354249|NCT01110915|O1|Outcome|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
354250|NCT01110915|O1|Outcome|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
354251|NCT01110915|E2|Reported Event|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
354252|NCT01110915|E1|Reported Event|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
354253|NCT01110707|B3|Baseline|Total|Total of all reporting groups
354254|NCT01110707|B2|Baseline|r-hFSH Alone|Subjects received subcutaneous injection of a recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]).
354255|NCT01110707|B1|Baseline|r-hFSH + r-hLH|Subjects received subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]) along with subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation. Administration of both r-hFSH and r-hLH was suspended 36 hours before administering recombinant human chorionic gonadotrophin (r-hCG).
354256|NCT01110707|P2|Participant Flow|r-hFSH Alone|Subjects received subcutaneous injection of a recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]).
354257|NCT01110707|P1|Participant Flow|r-hFSH + r-hLH|Subjects received subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]) along with subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation. Administration of both r-hFSH and r-hLH was suspended 36 hours before administering recombinant human chorionic gonadotrophin (r-hCG).
354258|NCT01110707|O2|Outcome|r-hFSH Alone|Subjects received subcutaneous injection of a recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]).
354259|NCT01110707|O1|Outcome|r-hFSH + r-hLH|Subjects received subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]) along with subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation. Administration of both r-hFSH and r-hLH was suspended 36 hours before administering recombinant human chorionic gonadotrophin (r-hCG).
354260|NCT01110707|O2|Outcome|r-hFSH Alone|Subjects received subcutaneous injection of a recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]).
354261|NCT01110707|O1|Outcome|r-hFSH + r-hLH|Subjects received subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]) along with subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation. Administration of both r-hFSH and r-hLH was suspended 36 hours before administering recombinant human chorionic gonadotrophin (r-hCG).
354262|NCT01110707|O2|Outcome|r-hFSH Alone|Subjects received subcutaneous injection of a recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]).
354263|NCT01110707|O1|Outcome|r-hFSH + r-hLH|Subjects received subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]) along with subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation. Administration of both r-hFSH and r-hLH was suspended 36 hours before administering recombinant human chorionic gonadotrophin (r-hCG).
354264|NCT01110707|O2|Outcome|r-hFSH Alone|Subjects received subcutaneous injection of a recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]).
354265|NCT01110707|O1|Outcome|r-hFSH + r-hLH|Subjects received subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]) along with subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation. Administration of both r-hFSH and r-hLH was suspended 36 hours before administering recombinant human chorionic gonadotrophin (r-hCG).
354266|NCT01110707|O2|Outcome|r-hFSH Alone|Subjects received subcutaneous injection of a recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]).
354267|NCT01110707|O1|Outcome|r-hFSH + r-hLH|Subjects received subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]) along with subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation. Administration of both r-hFSH and r-hLH was suspended 36 hours before administering recombinant human chorionic gonadotrophin (r-hCG).
354268|NCT01110707|O2|Outcome|r-hFSH Alone|Subjects received subcutaneous injection of a recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]).
354269|NCT01110707|O1|Outcome|r-hFSH + r-hLH|Subjects received subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]) along with subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation. Administration of both r-hFSH and r-hLH was suspended 36 hours before administering recombinant human chorionic gonadotrophin (r-hCG).
354270|NCT01110707|O2|Outcome|r-hFSH Alone|Subjects received subcutaneous injection of a recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]).
354271|NCT01110707|O1|Outcome|r-hFSH + r-hLH|Subjects received subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]) along with subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation. Administration of both r-hFSH and r-hLH was suspended 36 hours before administering recombinant human chorionic gonadotrophin (r-hCG).
354272|NCT01110707|O2|Outcome|r-hFSH Alone|Subjects received subcutaneous injection of a recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]).
354273|NCT01110707|O1|Outcome|r-hFSH + r-hLH|Subjects received subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]) along with subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation. Administration of both r-hFSH and r-hLH was suspended 36 hours before administering recombinant human chorionic gonadotrophin (r-hCG).
354274|NCT01110707|O2|Outcome|r-hFSH Alone|Subjects received subcutaneous injection of a recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]).
354275|NCT01110707|O1|Outcome|r-hFSH + r-hLH|GONAL-f (follitropin alpha); a recombinant human follicular stimulating hormone (r-hFSH) injection 300-450 International Units (IU) subcutaneously (SC) was administered separately after achieving pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a) at a dose of 0.1 milligram per day (mg/day). Subjects also received Luveris; recombinant human luteinizing hormone (r-hLH) injection 150 IU/day SC until the end of ovarian stimulation. Administration of both r-hFSH and r-hLH was suspended 36 hours before administering recombinant human chorionic gonadotrophin (r-hCG).
354276|NCT01110707|E2|Reported Event|r-hFSH Alone|Subjects received subcutaneous injection of a recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]).
354277|NCT01110707|E1|Reported Event|r-hFSH + r-hLH|Subjects received subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]) along with subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation. Administration of both r-hFSH and r-hLH was suspended 36 hours before administering recombinant human chorionic gonadotrophin (r-hCG).
354278|NCT01110499|B9|Baseline|Total|Total of all reporting groups
354279|NCT01110499|B8|Baseline|Part 2, Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
354280|NCT01110499|B7|Baseline|Part 2, AGN-210961 Formulation 7|AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks.
354281|NCT01110499|B6|Baseline|Part 1, AGN-210961 Formulation 6|AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
354282|NCT01110499|B5|Baseline|Part 1, AGN-210961 Formulation 5|AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
354283|NCT01110499|B4|Baseline|Part 1, AGN-210961 Formulation 4|AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
354284|NCT01110499|B3|Baseline|Part 1, AGN-210961 Formulation 3|AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
354285|NCT01110499|B2|Baseline|Part 1, AGN-210961 Formulation 2|AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
354286|NCT01110499|B1|Baseline|Part 1, AGN-210961 Formulation 1|AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
354287|NCT01110499|P8|Participant Flow|Part 2, Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
354288|NCT01110499|P7|Participant Flow|Part 2, AGN-210961 Formulation 7|AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks.
354289|NCT01110499|P6|Participant Flow|Part 1, AGN-210961 Formulation 6|AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
354290|NCT01110499|P5|Participant Flow|Part 1, AGN-210961 Formulation 5|AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
354291|NCT01110499|P4|Participant Flow|Part 1, AGN-210961 Formulation 4|AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
354292|NCT01110499|P3|Participant Flow|Part 1, AGN-210961 Formulation 3|AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
354293|NCT01110499|P2|Participant Flow|Part 1, AGN-210961 Formulation 2|AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
354294|NCT01110499|P1|Participant Flow|Part 1, AGN-210961 Formulation 1|AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
354295|NCT01110499|O2|Outcome|Part 2, Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
354296|NCT01110499|O1|Outcome|Part 2, AGN-210961 Formulation 7|AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks.
354297|NCT01110499|O7|Outcome|Part 1, Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03% in the other eye in all Part 1 treatment groups once daily for 7 days.
354298|NCT01110499|O6|Outcome|Part 1, AGN-210961 Formulation 6|AGN-210961 Formulation 6 in one eye once daily for 7 days.
354299|NCT01110499|O5|Outcome|Part 1, AGN-210961 Formulation 5|AGN-210961 Formulation 5 in one eye once daily for 7 days.
354300|NCT01110499|O4|Outcome|Part 1, AGN-210961 Formulation 4|AGN-210961 Formulation 4 in one eye once daily for 7 days.
354301|NCT01110499|O3|Outcome|Part 1, AGN-210961 Formulation 3|AGN-210961 Formulation 3 in one eye once daily for 7 days.
354302|NCT01110499|O2|Outcome|Part 1, AGN-210961 Formulation 2|AGN-210961 Formulation 2 in one eye once daily for 7 days.
354303|NCT01110499|O1|Outcome|Part 1, AGN-210961 Formulation 1|AGN-210961 Formulation 1 in one eye once daily for 7 days.
354304|NCT01110499|E9|Reported Event|Part 2, Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
354305|NCT01110499|E8|Reported Event|Part 2, AGN-210961 Formulation 7|AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks.
354306|NCT01110499|E7|Reported Event|Part 1, Bimatoprost Ophthalmic Solution 0.03% Treated Eye|bimatoprost ophthalmic solution 0.03% in the non-study eye once daily for 7 days (all bimatoprost ophthalmic solution 0.03% treated eyes in Part 1 combined).
354307|NCT01110499|E6|Reported Event|Part 1, AGN-210961 Formulation 6|AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
354308|NCT01110499|E5|Reported Event|Part 1, AGN-210961 Formulation 5|AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
354309|NCT01110499|E4|Reported Event|Part 1, AGN-210961 Formulation 4|AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
354310|NCT01110499|E3|Reported Event|Part 1, AGN-210961 Formulation 3|AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
354311|NCT01110499|E2|Reported Event|Part 1, AGN-210961 Formulation 2|AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
354312|NCT01110499|E1|Reported Event|Part 1, AGN-210961 Formulation 1|AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
354313|NCT01110421|B3|Baseline|Total|Total of all reporting groups
354314|NCT01110421|B2|Baseline|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354315|NCT01110421|B1|Baseline|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354316|NCT01110421|P2|Participant Flow|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354479|NCT01109979|E1|Reported Event|E+MPA|Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks
354317|NCT01110421|P1|Participant Flow|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354318|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354319|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354320|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354321|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354322|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354323|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354324|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354325|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354326|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354327|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354328|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354329|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354330|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354331|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354332|NCT01110421|E2|Reported Event|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354333|NCT01110421|E1|Reported Event|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354334|NCT01110408|B3|Baseline|Total|Total of all reporting groups
354335|NCT01110408|B2|Baseline|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354336|NCT01110408|B1|Baseline|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354337|NCT01110408|P2|Participant Flow|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354338|NCT01110408|P1|Participant Flow|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354339|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354340|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354341|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354342|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354343|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354344|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354345|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354346|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354347|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354348|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354349|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354350|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354351|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354352|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354353|NCT01110408|E2|Reported Event|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354354|NCT01110408|E1|Reported Event|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
354355|NCT01110382|B3|Baseline|Total|Total of all reporting groups
354356|NCT01110382|B2|Baseline|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
354357|NCT01110382|B1|Baseline|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
354358|NCT01110382|P2|Participant Flow|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
354359|NCT01110382|P1|Participant Flow|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
354360|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
354361|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
354362|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
354363|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
354364|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
354365|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
354366|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
354480|NCT01109849|B3|Baseline|Total|Total of all reporting groups
354711|NCT01108796|B3|Baseline|Tool (With Lifestyle Education Tool on Weight Reduction)|
354367|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
354368|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
354369|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
354370|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
354371|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
354372|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
354373|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
354374|NCT01110382|E2|Reported Event|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
354375|NCT01110382|E1|Reported Event|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
354376|NCT01110330|B4|Baseline|Total|Total of all reporting groups
354377|NCT01110330|B3|Baseline|Ketoconazole|Ketoconazole 2% cream (formulation F126)
354378|NCT01110330|B2|Baseline|Nizoral|Ketoconazole 2% cream (formulation F012) (Nizoral)
354379|NCT01110330|B1|Baseline|Placebo|A topical white homogenous cream identical in appearance to study drug
354380|NCT01110330|P3|Participant Flow|Ketoconazole|Ketoconazole 2% cream (formulation F126)
354381|NCT01110330|P2|Participant Flow|Nizoral|Ketoconazole 2% cream (formulation F012) (Nizoral)
354382|NCT01110330|P1|Participant Flow|Placebo|A topical white homogenous cream identical in appearance to study drug
354383|NCT01110330|O3|Outcome|Ketoconazole|Ketoconazole 2% cream (formulation F126)
354384|NCT01110330|O2|Outcome|Nizoral|Ketoconazole 2% cream (formulation F012) (Nizoral)
354385|NCT01110330|O1|Outcome|Placebo|A topical white homogenous cream identical in appearance to study drug
354386|NCT01110330|O3|Outcome|Ketoconazole|Ketoconazole 2% cream (formulation F126)
354387|NCT01110330|O2|Outcome|Nizoral|Ketoconazole 2% cream (formulation F012) (Nizoral)
354388|NCT01110330|O1|Outcome|Placebo|A topical white homogenous cream identical in appearance to study drug
354389|NCT01110330|E3|Reported Event|Placebo|A topical white homogenous cream identical in appearance to study drug
354390|NCT01110330|E2|Reported Event|Nizoral|Ketoconazole 2% cream (formulation F012) (Nizoral)
354391|NCT01110330|E1|Reported Event|Ketoconazole|Ketoconazole 2% cream (formulation F126)
354392|NCT01110252|B1|Baseline|Prior Then Post Procedure (Stem Cells Infusion)|emphysema patients evaluated prior or after the infusion of the autologous stem cells
354393|NCT01110252|P1|Participant Flow|Prior Then Post Procedure (Stem Cells Infusion)|emphysema patients evaluated prior or after the infusion of the autologous stem cells
354394|NCT01110252|O2|Outcome|Post Procedure (Stem Cells Infusion)|emphysema patients evaluated 30 days after the infusion of autologous stem cells
354395|NCT01110252|O1|Outcome|Prior to the Procedure (Stem Cells Infusion)|emphysema patients evaluated prior to the infusion of autologous stem cells
354396|NCT01110252|O2|Outcome|Post Procedure (Stem Cells Infusion)|emphysema patients evaluated 30 days after the infusion of autologous stem cells
354397|NCT01110252|O1|Outcome|Prior to the Procedure (Stem Cells Infusion)|emphysema patients evaluated prior to the infusion of autologous stem cells
354398|NCT01110252|O2|Outcome|Post Procedure (Stem Cells Infusion)|emphysema patients evaluated 30 days after the infusion of autologous stem cells
354399|NCT01110252|O1|Outcome|Prior to the Procedure (Stem Cells Infusion)|emphysema patients evaluated prior to the infusion of autologous stem cells
354400|NCT01110252|O2|Outcome|Post Procedure (Stem Cells Infusion)|emphysema patients evaluated 30 days after the infusion of autologous stem cells
354401|NCT01110252|O1|Outcome|Prior to the Procedure (Stem Cells Infusion)|emphysema patients evaluated prior to the infusion of autologous stem cells
354402|NCT01110252|O2|Outcome|Post Procedure (Stem Cells Infusion)|emphysema patients evaluated 30 days after the infusion of autologous stem cells
354403|NCT01110252|O1|Outcome|Prior to the Procedure (Stem Cells Infusion)|emphysema patients evaluated prior to the infusion of autologous stem cells
354404|NCT01110252|E1|Reported Event|Prior Then Post Procedure (Stem Cells Infusion)|emphysema patients evaluated prior or after the infusion of the autologous stem cells
354405|NCT01110239|B5|Baseline|Total|Total of all reporting groups
354406|NCT01110239|B4|Baseline|10 Min Ischemia|
354407|NCT01110239|B3|Baseline|7.5 Min Ischemia|
354408|NCT01110239|B2|Baseline|5 Min Ischemia|
354409|NCT01110239|B1|Baseline|Sham Preconditioning|Subjects with subarachnoid hemorrhage will undergo escalating times of limb ischemia to determine tolerability and safety. The leg will be made transiently ischemic with application of a blood pressure cuff for up to 3 cycles of 10 minutes.
354410|NCT01110239|P4|Participant Flow|10-min Ischemia|
354411|NCT01110239|P3|Participant Flow|7.5-min Ischemia|
354412|NCT01110239|P2|Participant Flow|5-min Ischemia|
354413|NCT01110239|P1|Participant Flow|Sham Preconditioning|Subjects with subarachnoid hemorrhage will undergo escalating times of limb ischemia to determine tolerability and safety. The leg will be made transiently ischemic with application of a blood pressure cuff for up to 3 cycles of 10 minutes. A sham preconditioning group was added with only minimal cuff inflation.
354414|NCT01110239|O4|Outcome|10 Min Ischemia|
354415|NCT01110239|O3|Outcome|7.5 Min Ischemia|
354416|NCT01110239|O2|Outcome|5 Min Ischemia|
354417|NCT01110239|O1|Outcome|Sham Preconditioning|Limb preconditioning intervention at increasing durations of ischemia: 5, 7.5 and 10 min.
354418|NCT01110239|O4|Outcome|10 Min Ischemia|
354419|NCT01110239|O3|Outcome|7.5 Min Ischemia|
354420|NCT01110239|O2|Outcome|5 Min Ischemia|
354421|NCT01110239|O1|Outcome|Sham Preconditioning|leg preconditioning with increasing durations of ischemia divided into 4 groups: sham preconditioning 3 cycles of 5min blood pressure cuff application 3 times 5 min cycles 3 times 7.5 min cycles 3 times 10 min cycles
354422|NCT01110239|E4|Reported Event|10 Min Ischemia|
354423|NCT01110239|E3|Reported Event|7.5 Min Ischemia|
354424|NCT01110239|E2|Reported Event|5 Min Ischemia|
354425|NCT01110239|E1|Reported Event|Sham Preconditioning|Subjects with subarachnoid hemorrhage will undergo escalating times of limb ischemia to determine tolerability and safety. The leg will be made transiently ischemic with application of a blood pressure cuff for up to 3 cycles of 10 minutes.
354426|NCT01110200|B3|Baseline|Total|Total of all reporting groups
354427|NCT01110200|B2|Baseline|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
354428|NCT01110200|B1|Baseline|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
354429|NCT01110200|P2|Participant Flow|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
354430|NCT01110200|P1|Participant Flow|FSC 250/50|Participants (par.) self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
354431|NCT01110200|O2|Outcome|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
354432|NCT01110200|O1|Outcome|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
354433|NCT01110200|O2|Outcome|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
354434|NCT01110200|O1|Outcome|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
354435|NCT01110200|O2|Outcome|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
354436|NCT01110200|O1|Outcome|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
354437|NCT01110200|O2|Outcome|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
354438|NCT01110200|O1|Outcome|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
354439|NCT01110200|O2|Outcome|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
354440|NCT01110200|O1|Outcome|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
354441|NCT01110200|E2|Reported Event|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
354442|NCT01110200|E1|Reported Event|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
354443|NCT01110187|B3|Baseline|Total|Total of all reporting groups
354444|NCT01110187|B2|Baseline|IV fPHT|patients randomized to IV fPHT (4)
354445|NCT01110187|B1|Baseline|IV LCM|patients randomized to IV LCM (7)
354446|NCT01110187|P2|Participant Flow|IV fPHT|"Patients randomized to fPHT (fos-phenytoin) with moderate or severe TBI. For IV fPHT dosing and adjustment see Intervention section."
354447|NCT01110187|P1|Participant Flow|IV LCM|"Patients with severe TBI later randomized to seizure prophylaxis with LCM (Lacosamide). For IV LCM dosing and adjustment see Intervention section."
354448|NCT01110187|O2|Outcome|IV fPHT|"Patients with TBI or SAH randomized to seizure prophylaxis with fos-phenytoin~Fosphenytoin: 20 mgPE/kg IV over 60 minutes and then will be started on a maintenance dose (5 mgPE/kg/day, rounded to nearest dose of 150 mgPE IV, BID administered as per pharmacy protocol consistent with acceptable standards of care for 7 days"
354582|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
354449|NCT01110187|O1|Outcome|IV LCM|"Patients with severe traumatic brain injury (TBI) or subarachanoid hemorrhage (SAH) randomized to seizure prophylaxis with either lacosamide.~lacosamide: 200 mg IV over 60 minutes; these patients will then be started on a maintenance dose 100 mg, IV BID as prophylaxis administered as per pharmacy protocol consistent with acceptable standards of care for 7 days. The Lacosamide dose can be adjusted as needed if seizures occur for therapeutic effect up to 200 mg bid (400 mg/d) as a maximum dose."
354450|NCT01110187|O2|Outcome|IV fPHT|Patients with severe TBI randomized to seizure prophylaxis with fPHT
354451|NCT01110187|O1|Outcome|IV LCM|Patients with severe TBI later randomized to seizure prophylaxis with lacosamide.
354452|NCT01110187|E2|Reported Event|IV fPHT|Patients with severe TBI later randomized to seizure prophylaxis with phenytoin.
354453|NCT01110187|E1|Reported Event|IV LCM|Patients with severe TBI later randomized to seizure prophylaxis with lacosamide.
354454|NCT01110135|B1|Baseline|Treatment (Chemotherapy and Colony-stimulating Factor)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until > 5 x 10^6 CD34+/kg has been collected.~bendamustine hydrochloride: Given IV~dexamethasone: Given PO~filgrastim: Given SC~leukapheresis: Given IV~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies~etoposide: Given IV"
354455|NCT01110135|P1|Participant Flow|Treatment (Chemotherapy and Colony-stimulating Factor)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until > 5 x 10^6 CD34+/kg has been collected.~bendamustine hydrochloride: Given IV~dexamethasone: Given PO~filgrastim: Given SC~leukapheresis: Given IV~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies~etoposide: Given IV"
354456|NCT01110135|O1|Outcome|Treatment (Chemotherapy and Colony-stimulating Factor)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until > 5 x 10^6 CD34+/kg has been collected.~bendamustine hydrochloride: Given IV~dexamethasone: Given PO~filgrastim: Given SC~leukapheresis: Given IV~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies~etoposide: Given IV"
354457|NCT01110135|E1|Reported Event|Treatment (Chemotherapy and Colony-stimulating Factor)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until > 5 x 10^6 CD34+/kg has been collected.~bendamustine hydrochloride: Given IV~dexamethasone: Given PO~filgrastim: Given SC~leukapheresis: Given IV~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies~etoposide: Given IV"
354458|NCT01110005|B3|Baseline|Total|Total of all reporting groups
354459|NCT01110005|B2|Baseline|Lactated Ringers Solution (LR)|Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
354460|NCT01110005|B1|Baseline|D5 Lactated Ringers Solution (D5LR)|IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
354461|NCT01110005|P2|Participant Flow|Lactated Ringers Solution (LR)|Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
354462|NCT01110005|P1|Participant Flow|D5 Lactated Ringers Solution (D5LR)|IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
354463|NCT01110005|O2|Outcome|Lactated Ringers Solution (LR)|Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
354464|NCT01110005|O1|Outcome|D5 Lactated Ringers Solution (D5LR)|IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
354465|NCT01110005|O2|Outcome|Lactated Ringers Solution (LR)|Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
354466|NCT01110005|O1|Outcome|D5 Lactated Ringers Solution (D5LR)|IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
354467|NCT01110005|O2|Outcome|Lactated Ringers Solution (LR)|Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
354468|NCT01110005|O1|Outcome|D5 Lactated Ringers Solution (D5LR)|IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
354469|NCT01110005|E2|Reported Event|Lactated Ringers Solution (LR)|Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
354470|NCT01110005|E1|Reported Event|D5 Lactated Ringers Solution (D5LR)|IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
354471|NCT01109979|B3|Baseline|Total|Total of all reporting groups
354472|NCT01109979|B2|Baseline|E+DRSP, Then E+MPA|Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks, then 4 week washout before Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks
354473|NCT01109979|B1|Baseline|E+MPA, Then E+DRSP|Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks, then 4 week washout before Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks
354474|NCT01109979|P2|Participant Flow|E+DRSP, Then E+MPA|Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks, then 4 week washout before Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks
354475|NCT01109979|P1|Participant Flow|E+MPA, Then E+DRSP|Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks, then 4 week washout before Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks
354476|NCT01109979|O2|Outcome|E+DRSP|Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks
354477|NCT01109979|O1|Outcome|E+MPA|Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks
356808|NCT01104584|O1|Outcome|CMRM vs UMRM|
354481|NCT01109849|B2|Baseline|ER Stimulant|"daily use of 12 hour extended release methylphenidate product~12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm"
354482|NCT01109849|B1|Baseline|Behavior Therapy|"10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject~behavioral therapy: combination of individual and group parent training plus school consultation"
354483|NCT01109849|P5|Participant Flow|Monitoring|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks and continuation of daily extended release stimulant.
354484|NCT01109849|P4|Participant Flow|Drug Holiday|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks and limiting CNS stimulant medication to school days only.
354485|NCT01109849|P3|Participant Flow|Caloric Supplementation|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks, continuation of a daily extended release stimulant and the addition of a liquid 8oz caloric supplement every evening.
354486|NCT01109849|P2|Participant Flow|ER Stimulant|"daily use of 12 hour extended release (ER) methylphenidate product~12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm"
354487|NCT01109849|P1|Participant Flow|Behavior Therapy|"10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject~behavioral therapy: combination of individual and group parent training plus school consultation"
354488|NCT01109849|O3|Outcome|Monitoring|"Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery and were randomly assigned to 1 of 3 weight recovery treatments and did not change their frequency of medication use after the weight recovery randomization (either used the majority of non school days pre and post randomization or did not use med the majority of non school days pre and post randomization).~This arm also consisted of monthly weight checks."
354489|NCT01109849|O2|Outcome|Drug Holiday|"Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery and were previously using medication on the majority of non school days but then stopped using medication on the majority of non school days.~This arm also consisted of monthly weight checks and use of ER stimulant on school days only."
354490|NCT01109849|O1|Outcome|Caloric Supplementation|"Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery and used caloric supplementation for at least the majority of the days in the weight recovery phase.~This arm also consisted of monthly weight checks, continuation of a daily extended release stimulant."
354491|NCT01109849|O3|Outcome|Monitoring|"Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery and were randomly assigned to 1 of 3 weight recovery treatments and did not change their frequency of medication use after the weight recovery randomization (either used the majority of non school days pre and post randomization or did not use med the majority of non school days pre and post randomization).~This arm also consisted of monthly weight checks."
354492|NCT01109849|O2|Outcome|Drug Holiday|"Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery and were previously using medication on the majority of non school days but then stopped using medication on the majority of non school days.~This arm also consisted of monthly weight checks and use of ER stimulant on school days only."
354493|NCT01109849|O1|Outcome|Caloric Supplementation|"Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery and used caloric supplementation for at least the majority of the days in the weight recovery phase.~This arm also consisted of monthly weight checks, continuation of a daily extended release stimulant."
354494|NCT01109849|O3|Outcome|Monitoring|"Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery and were randomly assigned to 1 of 3 weight recovery treatments and did not change their frequency of medication use after the weight recovery randomization (either used the majority of non school days pre and post randomization or did not use med the majority of non school days pre and post randomization).~This arm also consisted of monthly weight checks."
354495|NCT01109849|O2|Outcome|Drug Holiday|"Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery and were previously using medication on the majority of non school days but then stopped using medication on the majority of non school days.~This arm also consisted of monthly weight checks and use of ER stimulant on school days only."
354496|NCT01109849|O1|Outcome|Caloric Supplementation|"Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery and used caloric supplementation for at least the majority of the days in the weight recovery phase.~This arm also consisted of monthly weight checks, continuation of a daily extended release stimulant."
354497|NCT01109849|O3|Outcome|Rare Medication Group|measures change in z height from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rare med group used med <12.5% of the study duration (with most using not at all).
354498|NCT01109849|O2|Outcome|Inconsistent Medication Group|measures change in z height from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The inconsistent med group used med at least 12.5% of the time in the study but less than 87.5% of the time in the study (mean usage was 45% of time in study).
354499|NCT01109849|O1|Outcome|Consistent Medication|participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rarely med group (n=44, 29.5% female) used med <12.5% of the study duration (with most using not at all). The consistent med group used med for at least 87.5% of their time in the study with most using the entire time.
354583|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
354500|NCT01109849|O3|Outcome|Rare Medication Group|measures change in z height from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rare med group used med <12.5% of the study duration (with most using not at all).
354501|NCT01109849|O2|Outcome|Inconsistent Medication Group|measures change in z height from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The inconsistent med group used med at least 12.5% of the time in the study but less than 87.5% of the time in the study (mean usage was 45% of time in study).
354502|NCT01109849|O1|Outcome|Consistent Medication|participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rarely med group (n=44, 29.5% female) used med <12.5% of the study duration (with most using not at all). The consistent med group used med for at least 87.5% of their time in the study with most using the entire time.
354503|NCT01109849|O3|Outcome|Rare Medication Group|measures change in z height from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rare med group used med <12.5% of the study duration (with most using not at all).
354504|NCT01109849|O2|Outcome|Inconsistent Medication Group|measures change in z height from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The inconsistent med group used med at least 12.5% of the time in the study but less than 87.5% of the time in the study (mean usage was 45% of time in study).
354505|NCT01109849|O1|Outcome|Consistent Medication|participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rarely med group (n=44, 29.5% female) used med <12.5% of the study duration (with most using not at all). The consistent med group used med for at least 87.5% of their time in the study with most using the entire time.
354506|NCT01109849|O3|Outcome|Monitoring|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks and continuation of daily extended release stimulant.
354507|NCT01109849|O2|Outcome|Drug Holiday|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks and limiting CNS stimulant medication to school days only.
354508|NCT01109849|O1|Outcome|Caloric Supplementation|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks, continuation of a daily extended release stimulant and the addition of a liquid 8oz caloric supplement every evening.
354509|NCT01109849|O3|Outcome|Monitoring|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks and continuation of daily extended release stimulant.
354510|NCT01109849|O2|Outcome|Drug Holiday|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks and limiting CNS stimulant medication to school days only.
354511|NCT01109849|O1|Outcome|Caloric Supplementation|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks, continuation of a daily extended release stimulant and the addition of a liquid 8oz caloric supplement every evening.
354512|NCT01109849|O3|Outcome|Monitoring|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks and continuation of daily extended release stimulant.
354513|NCT01109849|O2|Outcome|Drug Holiday|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks and limiting CNS stimulant medication to school days only.
354514|NCT01109849|O1|Outcome|Caloric Supplementation|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks, continuation of a daily extended release stimulant and the addition of a liquid 8oz caloric supplement every evening.
354515|NCT01109849|O2|Outcome|ER Stimulant|"daily use of 12 hour extended release methylphenidate product~12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm Med group allowed to participate in initial basic parent training course Additional Behavioral therapy services allowed after month 6 if still moderately impaired or worse on Clinical Global Impressions"
354516|NCT01109849|O1|Outcome|Behavior Therapy|"10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject~behavioral therapy: combination of individual and group parent training plus school consultation medication usage allowed after month 6 if still moderately impaired or worse on Clinical Global Impressions"
354517|NCT01109849|O2|Outcome|ER Stimulant|"daily use of 12 hour extended release methylphenidate product~12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm"
354518|NCT01109849|O1|Outcome|Behavior Therapy|"10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject~behavioral therapy: combination of individual and group parent training plus school consultation medication usage allowed after month 6 if still moderately impaired or worse on Clinical Global Impressions"
354712|NCT01108796|B2|Baseline|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
354519|NCT01109849|O2|Outcome|ER Stimulant|"daily use of 12 hour extended release methylphenidate product~12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm"
354520|NCT01109849|O1|Outcome|Behavior Therapy|"10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject~behavioral therapy: combination of individual and group parent training plus school consultation medication usage allowed after month 6 if still moderately impaired or worse on Clinical Global Impressions"
354521|NCT01109849|O2|Outcome|ER Stimulant|"daily use of 12 hour extended release methylphenidate product~12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm"
354522|NCT01109849|O1|Outcome|Behavior Therapy|"10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject~behavioral therapy: combination of individual and group parent training plus school consultation medication usage allowed after month 6 if still moderately impaired or worse on Clinical Global Impressions"
354523|NCT01109849|O2|Outcome|ER Stimulant|"daily use of 12 hour extended release methylphenidate product~12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm"
354524|NCT01109849|O1|Outcome|Behavior Therapy|"10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject~behavioral therapy: combination of individual and group parent training plus school consultation"
354525|NCT01109849|O1|Outcome|Weight Promotion Treatment- Caloric Supplement|"Subjects in either the behavior therapy arm or the medication arm will be assigned to one of 3 treatments if subject does not meet projected BMI goals- either increased monitoring of growth, caloric supplement or drug holiday where only use ADHD medication for school~12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm~increased monitoring of growth: monthly weight, height and BMI checks~drug holiday: switch from seven day a week dosing to medication only on school days~caloric supplement: continue current ADHD regimen and add one 8oz liquid caloric supplement at night"
354526|NCT01109849|O2|Outcome|ER Stimulant|"daily use of 12 hour extended release methylphenidate product~12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm"
354527|NCT01109849|O1|Outcome|Behavior Therapy|"10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject~behavioral therapy: combination of individual and group parent training plus school consultation~medication usage allowed after month 6 if still moderately impaired or worse on Clinical Global Impressions"
354528|NCT01109849|O2|Outcome|ER Stimulant|"daily use of 12 hour extended release methylphenidate product~12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm"
354529|NCT01109849|O1|Outcome|Behavior Therapy|"10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject~behavioral therapy: combination of individual and group parent training plus school consultation medication usage allowed after month 6 if still moderately impaired or worse on Clinical Global Impressions"
354530|NCT01109849|O2|Outcome|ER Stimulant|"daily use of 12 hour extended release methylphenidate product~12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm"
354531|NCT01109849|O1|Outcome|Behavior Therapy|"10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject~behavioral therapy: combination of individual and group parent training plus school consultation~medication usage allowed after month 6 if still moderately impaired or worse on Clinical Global Impressions"
354532|NCT01109849|E3|Reported Event|Dose Optimzed|This arm includes the 142 participants that had their dose of study medication systematically optimized through assessment of efficacy and tolerability at home and school. There participants could have come from either of the other two arms- initially assigned to either med or behavior. We added this post hoc arm as a subset of participants randomized to med never used med and a subset of behavior randomized participants did use medication. This group reports adverse event rates only in participants who used med for a sufficient duration to have their dose optimized.
354533|NCT01109849|E2|Reported Event|ER Stimulant|"Participants completing a baseline assessment and at least one post baseline assessment of adverse events who were initially assigned to daily use of extended release CNS Stimulant~All study medication was prescribed to be taken daily for duration of study unless assigned to weight promotion drug holiday arm~includes all participants with at least one post baseline assessment of adverse events"
354534|NCT01109849|E1|Reported Event|Behavior Therapy|"Participants completing a baseline assessment and at least one post baseline assessment of adverse events and were initially assigned to behavior arm which included a basic parenting intervention, additional advanced 8 week parent training intervention, monthly boosters, option for individual parent training sessions, and a school consultant assigned to each subject.~Medication usage allowed after month 6 if at least moderately impaired~includes all participants with at least one post baseline assessment of adverse events"
354535|NCT01109602|B4|Baseline|Total|Total of all reporting groups
354536|NCT01109602|B3|Baseline|Arm 3: Wait List Control Group|wait-list control: will be assessed before and after 8 weeks. Will then be offered the 8 week yoga intervention.
354537|NCT01109602|B2|Baseline|Arm 2: Yoga Group Plus|"Yoga Group Plus: 8 week, bi-weekly in-person yoga training focused on strength, flexibility, and balance paired with almost daily at home yoga focused on breathing and relaxation. Data for both yoga groups were combined for analyses based off of data from the results.~Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
354584|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
354585|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
354538|NCT01109602|B1|Baseline|Arm 1: Yoga Group|"Yoga Group, 8 week bi-weekly in-person yoga training focused on strength, flexibility, and balance~Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
354539|NCT01109602|P3|Participant Flow|Arm 3: Wait List Control Group|wait-list control: will be assessed before and after 8 weeks. Will then be offered the 8 week yoga intervention.
354540|NCT01109602|P2|Participant Flow|Arm 2: Yoga Group Plus|"Yoga Group Plus: 8 week, bi-weekly in-person yoga training focused on strength, flexibility, and balance paired with almost daily at home yoga focused on breathing and relaxation. Data for both yoga groups were combined for analyses based off of data from the results.~Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
354541|NCT01109602|P1|Participant Flow|Arm 1: Yoga Group|"Yoga Group, 8 week bi-weekly in-person yoga training focused on strength, flexibility, and balance~Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
354542|NCT01109602|O2|Outcome|Wait List Control Group|Participants randomized to the Wait list control group were assessed and then waited for 8 weeks for no additional intervention, just usual care. they were then assessed again 8 weeks later.
354543|NCT01109602|O1|Outcome|Yoga/Yoga Plus|Data for both yoga groups were combined for analyses. All participants received 8 weeks of group yoga twice a week. Participants randomized to 'yoga plus' also received an audio recording for meditation/relaxation. there were no differences between groups, thus the data were combined.
354544|NCT01109602|O2|Outcome|Wait List Control Group|Participants randomized to the Wait list control group were assessed and then waited for 8 weeks for no additional intervention, just usual care. they were then assessed again 8 weeks later.
354545|NCT01109602|O1|Outcome|Yoga/Yoga Plus|Data for both yoga groups were combined for analyses. All participants received 8 weeks of group yoga twice a week. Participants randomized to 'yoga plus' also received an audio recording for meditation/relaxation. there were no differences between groups, thus the data were combined.
354546|NCT01109602|O2|Outcome|Wait List Control Group|Participants randomized to the Wait list control group were assessed and then waited for 8 weeks for no additional intervention, just usual care. they were then assessed again 8 weeks later.
354547|NCT01109602|O1|Outcome|Yoga/Yoga Plus|Data for both yoga groups were combined for analyses. All participants received 8 weeks of group yoga twice a week. Participants randomized to 'yoga plus' also received an audio recording for meditation/relaxation. there were no differences between groups, thus the data were combined.
354548|NCT01109602|E3|Reported Event|Arm 3: Wait List Control Group|wait-list control: will be assessed before and after 8 weeks. Will then be offered the 8 week yoga intervention.
354549|NCT01109602|E2|Reported Event|Arm 2: Yoga Group Plus|"Yoga Group Plus: 8 week, bi-weekly in-person yoga training focused on strength, flexibility, and balance paired with almost daily at home yoga focused on breathing and relaxation. Data for both yoga groups were combined for analyses based off of data from the results.~Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
354550|NCT01109602|E1|Reported Event|Arm 1: Yoga Group|"Yoga Group, 8 week bi-weekly in-person yoga training focused on strength, flexibility, and balance~Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
354551|NCT01109576|B1|Baseline|DSL Workshop Participants|"Three to five Veterans with DSL.~DSL Workshop: A series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers."
354552|NCT01109576|P1|Participant Flow|DSL Workshop Participants|"Three to five Veterans with DSL.~DSL Workshop: A series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers.~Participant Flow Completed: Twelve participants completed the entire protocol, including all outcomes measures."
354553|NCT01109576|O1|Outcome|DSL Workshop Participants|"Three to five Veterans with DSL.~DSL Workshop: A series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers."
354554|NCT01109576|E1|Reported Event|DSL Workshop Participants|"Dual Sensory Loss (DSL) workshop participants. Three to five Veterans with DSL.~DSL Workshop: A series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers."
354586|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
354587|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
354588|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
356809|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
354555|NCT01109524|B1|Baseline|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
354556|NCT01109524|P1|Participant Flow|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI)decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
354557|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
354558|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
354559|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
354560|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
354561|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
354589|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
354590|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
354591|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
354562|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
354563|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
354564|NCT01109524|E1|Reported Event|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter squared (m²), week 1, then 250mg/m² weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI)decision stopped the treatment. One hour of observation required after each infusion. IV cisplatin, 25 mg/m², Day 1 and 8 of each 21 day cycle, Maximum 6 cycles. Pre-cisplatin hydration could begin during 1-hour post cetuximab observation period. IV vinorelbine, 80mg/m², Day 1 of each 21 day cycle, maximum 6 cycles. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
354565|NCT01109381|B1|Baseline|Treatment|"Initial phase - omeprazole, NAC, lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid~GT08 : omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily"
354566|NCT01109381|P1|Participant Flow|GT08|"Initial phase - omeprazole, N-acetylcysteine (NAC), lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid~GT08 : omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily"
354567|NCT01109381|O1|Outcome|Treatment|"Initial phase - omeprazole, NAC (N-acetyl cysteine), lauric acid with dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid~GT08 is the combination of omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily"
354568|NCT01109381|O1|Outcome|Treatment|"Initial phase - omeprazole, NAC, lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid~GT08 : omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily"
354569|NCT01109381|O1|Outcome|Treatment With GT08|"Initial phase - omeprazole, N-acetyl cysteine (NAC), lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid~GT08 means treatment with omeprazole 40mg daily, lauric acid 150-300mg daily, and NAC 1.2 - 2g daily"
354570|NCT01109381|E1|Reported Event|Treatment|"Initial phase - omeprazole, NAC, lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid~GT08 : omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily"
354571|NCT01109316|B7|Baseline|Total|Total of all reporting groups
354572|NCT01109316|B6|Baseline|A6D/L6D/L2D|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 week treatment period, followed by Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks, followed by Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 weeks.
354573|NCT01109316|B5|Baseline|A6D/L2D/L6D|Insulin Aspart 6 Day (L6D) administered by infusion pump for 8 week treatment period, followed by Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 weeks, followed by Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
354574|NCT01109316|B4|Baseline|L6D/A6D/L2D|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 week treatment period, followed by Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks, followed by Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 weeks.
354575|NCT01109316|B3|Baseline|L6D/L2D/A6D|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 week treatment period, followed by Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 weeks, followed by Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
354576|NCT01109316|B2|Baseline|L2D/A6D/L6D|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period, followed by Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks, followed by Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
354577|NCT01109316|B1|Baseline|L2D/L6D/A6D|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period, followed by Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks, followed by Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
354578|NCT01109316|P3|Participant Flow|Insulin Aspart 6 Day (A6D)|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks in either Study Period 1, 2, or 3.
354579|NCT01109316|P2|Participant Flow|Insulin Lispro 6 Day (L6D)|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks in either Study Period 1, 2, or 3.
354580|NCT01109316|P1|Participant Flow|Insulin Lispro 2 Day (L2D)|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 weeks in either Study Period 1, 2, or 3.
354581|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
354593|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
354594|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
354595|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
354596|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
354597|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
354598|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
354599|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
354600|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
354601|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
354602|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
354603|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
354604|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
354605|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
354606|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
354607|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
354608|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
354609|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
354610|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
354611|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
354612|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
354613|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
354614|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
354615|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
354616|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
354617|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
354618|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
354619|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
354620|NCT01109316|E3|Reported Event|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
354621|NCT01109316|E2|Reported Event|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
354622|NCT01109316|E1|Reported Event|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
354623|NCT01109173|B5|Baseline|Total|Total of all reporting groups
354624|NCT01109173|B4|Baseline|NEVANAC Vehicle|Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
354625|NCT01109173|B3|Baseline|Nepafenac Vehicle 0.3%|Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
354626|NCT01109173|B2|Baseline|NEVANAC|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
354627|NCT01109173|B1|Baseline|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
354628|NCT01109173|P4|Participant Flow|NEVANAC Vehicle|Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
354629|NCT01109173|P3|Participant Flow|Nepafenac Vehicle 0.3%|Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
354630|NCT01109173|P2|Participant Flow|NEVANAC|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
354631|NCT01109173|P1|Participant Flow|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
354632|NCT01109173|O4|Outcome|NEVANAC Vehicle|Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
354633|NCT01109173|O3|Outcome|Nepafenac Vehicle 0.3%|Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
354634|NCT01109173|O2|Outcome|NEVANAC|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
354635|NCT01109173|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
354636|NCT01109173|O4|Outcome|NEVANAC Vehicle|Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
354637|NCT01109173|O3|Outcome|Nepafenac Vehicle 0.3%|Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
354638|NCT01109173|O2|Outcome|NEVANAC|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
354639|NCT01109173|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
354640|NCT01109173|E4|Reported Event|NEVANAC Vehicle|Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
354641|NCT01109173|E3|Reported Event|Nepafenac Vehicle 0.3%|Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
354642|NCT01109173|E2|Reported Event|NEVANAC|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
354643|NCT01109173|E1|Reported Event|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
354644|NCT01109147|B4|Baseline|Total|Total of all reporting groups
354645|NCT01109147|B3|Baseline|Control|healthy volunteers
354646|NCT01109147|B2|Baseline|Risperidone|Schizophrenic patient stabilized under risperidone for six weeks before inclusion
354647|NCT01109147|B1|Baseline|Aripiprazole|Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion
354648|NCT01109147|P3|Participant Flow|Control|healthy volunteers
354649|NCT01109147|P2|Participant Flow|Risperidone|Schizophrenic patient stabilized under risperidone for six weeks before inclusion
354650|NCT01109147|P1|Participant Flow|Aripiprazole|Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion
354651|NCT01109147|O3|Outcome|Control|healthy volunteers
354652|NCT01109147|O2|Outcome|Risperidone|Schizophrenic patient stabilized under risperidone for six weeks before inclusion
354653|NCT01109147|O1|Outcome|Aripiprazole|Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion
354654|NCT01109147|E3|Reported Event|Control|healthy volunteers
354655|NCT01109147|E2|Reported Event|Risperidone|Schizophrenic patient stabilized under risperidone for six weeks before inclusion
354656|NCT01109147|E1|Reported Event|Aripiprazole|Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion
354657|NCT01109108|B3|Baseline|Total|Total of all reporting groups
354658|NCT01109108|B2|Baseline|Children 2<5 Years of Age|Children 2<5 years of age with and without concurrent respiratory tract infection
354659|NCT01109108|B1|Baseline|Children 0<2 Years of Age|Children 0<2 years of age with and without concurrent respiratory tract infection
354660|NCT01109108|P2|Participant Flow|Children 2<5 Years of Age|Children 2<5 years of age with and without respiratory tract infection
354661|NCT01109108|P1|Participant Flow|Children 0<2 Years of Age|Children 0<2 years of age with and without respiratory tract infection
354662|NCT01109108|O2|Outcome|Children 2<5 Years of Age|Children 2<5 years of age with and without respiratory tract infection
354663|NCT01109108|O1|Outcome|Children 0<2 Years of Age|Children 0<2 years of age with and without respiratory tract infection
354664|NCT01109108|E2|Reported Event|Children 2<5 Years of Age|Children 2<5 years of age with and without respiratory tract infection
354665|NCT01109108|E1|Reported Event|Children <2 Years of Age|Children <2 years of age with and without respiratory tract infection
354666|NCT01109056|B3|Baseline|Total|Total of all reporting groups
354667|NCT01109056|B2|Baseline|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
354668|NCT01109056|B1|Baseline|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
354669|NCT01109056|P2|Participant Flow|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
354670|NCT01109056|P1|Participant Flow|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
354671|NCT01109056|O2|Outcome|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
354672|NCT01109056|O1|Outcome|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
354673|NCT01109056|O2|Outcome|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
354674|NCT01109056|O1|Outcome|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
354675|NCT01109056|O2|Outcome|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
354676|NCT01109056|O1|Outcome|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
354677|NCT01109056|E2|Reported Event|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
354678|NCT01109056|E1|Reported Event|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
354679|NCT01108835|B3|Baseline|Total|Total of all reporting groups
354680|NCT01108835|B2|Baseline|Control Group|Control arm with usual care
354681|NCT01108835|B1|Baseline|Comprehensive Care|"Comprehensive care~Comprehensive care programme: Intervention group:~Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions~Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)~Respiratory physician assessment and optimization of treatment~Patients will also be taught about a personalized action plan by the physician and respiratory nurse.~Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
354682|NCT01108835|P2|Participant Flow|Control Group|Control arm with usual care
354683|NCT01108835|P1|Participant Flow|Comprehensive Care|"Comprehensive care~Comprehensive care programme: Intervention group:~Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions~Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)~Respiratory physician assessment and optimization of treatment~Patients will also be taught about a personalized action plan by the physician and respiratory nurse.~Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
354684|NCT01108835|O2|Outcome|Control Group|Control arm with usual care
354685|NCT01108835|O1|Outcome|Comprehensive Care|"Comprehensive care~Comprehensive care programme: Intervention group:~Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions~Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)~Respiratory physician assessment and optimization of treatment~Patients will also be taught about a personalized action plan by the physician and respiratory nurse.~Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
354686|NCT01108835|O2|Outcome|Control Group|Control arm with usual care
354687|NCT01108835|O1|Outcome|Comprehensive Care|"Comprehensive care~Comprehensive care programme: Intervention group:~Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions~Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)~Respiratory physician assessment and optimization of treatment~Patients will also be taught about a personalized action plan by the physician and respiratory nurse.~Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
354688|NCT01108835|O2|Outcome|Control Group|Control arm with usual care
354689|NCT01108835|O1|Outcome|Comprehensive Care|"Comprehensive care~Comprehensive care programme: Intervention group:~Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions~Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)~Respiratory physician assessment and optimization of treatment~Patients will also be taught about a personalized action plan by the physician and respiratory nurse.~Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
354690|NCT01108835|O2|Outcome|Control Group|Control arm with usual care
354691|NCT01108835|O1|Outcome|Comprehensive Care Programme|"Comprehensive care involving multidisciplinary input.~Comprehensive care programme: Intervention group:~Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions~Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)~Respiratory physician assessment and optimization of treatment~Patients will also be taught about a personalized action plan by the physician and respiratory nurse.~Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
354692|NCT01108835|O2|Outcome|Control Group|Control arm with usual care
354693|NCT01108835|O1|Outcome|Comprehensive Care|"Comprehensive care~Comprehensive care programme: Intervention group:~Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions~Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)~Respiratory physician assessment and optimization of treatment~Patients will also be taught about a personalized action plan by the physician and respiratory nurse.~Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
354694|NCT01108835|E2|Reported Event|Control Group|Control arm with usual care
354695|NCT01108835|E1|Reported Event|Comprehensive Care|"Comprehensive care~Comprehensive care programme: Intervention group:~Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions~Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)~Respiratory physician assessment and optimization of treatment~Patients will also be taught about a personalized action plan by the physician and respiratory nurse.~Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
354696|NCT01108809|B1|Baseline|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
354697|NCT01108809|P1|Participant Flow|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
354698|NCT01108809|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
354699|NCT01108809|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
354700|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
354701|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
354702|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
354703|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
354704|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
354705|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
354706|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
354707|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
356810|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
354713|NCT01108796|B1|Baseline|Micardis® (Telmisartan)|Patients were enrolled into two groups, receiving treatment with Micardis or MicardisPlus and in addition with Tool or No Tool. The system summarizes the number of patients automatically. The total number is always 1841.
354714|NCT01108796|P2|Participant Flow|MicardisPlus® (Telmisartan Hydrochlorothiazide)|These patients in addition received Tool or No Tool treatment
354715|NCT01108796|P1|Participant Flow|Micardis® (Telmisartan)|These patients in addition received Tool or No Tool treatment
354716|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
354717|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
354718|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
354719|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
354720|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
354721|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
354722|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
354723|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
354724|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
354725|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
354726|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
354727|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
354728|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
354729|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
354730|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
354731|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
354732|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
354733|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
354734|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
354735|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
354736|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
354737|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
354738|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
354739|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
354740|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
354741|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
354742|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
354743|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
354744|NCT01108796|E2|Reported Event|MicardisPlus® (Telmisartan Hydrochlorothiazide)|These patients in addition received Tool or No Tool treatment
354745|NCT01108796|E1|Reported Event|Micardis® (Telmisartan)|These patients in addition received Tool or No Tool treatment
354746|NCT01108757|B3|Baseline|Total|Total of all reporting groups
354747|NCT01108757|B2|Baseline|Placebo|Placebo: Corn starch capsules
354748|NCT01108757|B1|Baseline|Drug|"Bactrim: Bactrim DS BID for 3 days~Demographics data by group not available as this study was discontinued in 2013. Currently randomization data not available for reassessment."
354749|NCT01108757|P2|Participant Flow|Placebo|Placebo: Corn starch capsules
354750|NCT01108757|P1|Participant Flow|Drug|Bactrim: Bactrim DS BID for 3 days
354751|NCT01108757|O2|Outcome|Placebo|Placebo: Corn starch capsules
354752|NCT01108757|O1|Outcome|Drug|Bactrim: Bactrim DS BID for 3 days
354753|NCT01108757|E2|Reported Event|Placebo|Placebo: Corn starch capsules
354754|NCT01108757|E1|Reported Event|Drug|Bactrim: Bactrim DS BID for 3 days
354755|NCT01108731|B3|Baseline|Total|Total of all reporting groups
354756|NCT01108731|B2|Baseline|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
354757|NCT01108731|B1|Baseline|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
354758|NCT01108731|P2|Participant Flow|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
354759|NCT01108731|P1|Participant Flow|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
354760|NCT01108731|O2|Outcome|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
354761|NCT01108731|O1|Outcome|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
354762|NCT01108731|O2|Outcome|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
354763|NCT01108731|O1|Outcome|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
354764|NCT01108731|O2|Outcome|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
356811|NCT01104584|O1|Outcome|CMRM vs UMRM|
354765|NCT01108731|O1|Outcome|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
354766|NCT01108731|E2|Reported Event|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
354767|NCT01108731|E1|Reported Event|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
354768|NCT01108718|B3|Baseline|Total|Total of all reporting groups
354769|NCT01108718|B2|Baseline|Subjects Who Receive the Control Mattress First(2 Months)|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the control mattress first.
354770|NCT01108718|B1|Baseline|Subjects Who Receive Tempur-Pedic Mattress First(2 Months)|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the Tempur-Pedic mattress first.
354771|NCT01108718|P2|Participant Flow|Subjects Who Received the Control Mattress First|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the control mattress first, then the Tempur-pedic mattress.
354772|NCT01108718|P1|Participant Flow|Subjects Who Received the Tempur-Pedic Mattress First|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the Tempur-Pedic mattress first, then the Control Mattress.
354773|NCT01108718|O1|Outcome|All Participants|All subjects used a tempur-pedic mattress and control mattress to sleep on in a cross over design for a period of 2 months per mattress.
354774|NCT01108718|E2|Reported Event|Subjects Who Received the Control Mattress First|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the control mattress first.
354775|NCT01108718|E1|Reported Event|Subjects Who Received Tempur-Pedic Mattress First|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the Tempur-Pedic mattress first.
354776|NCT01108523|B1|Baseline|HP828-101|HP828-101 Experimental Formulation
354777|NCT01108523|P1|Participant Flow|HP828-101|HP828-101 Experimental Formulation
354778|NCT01108523|O1|Outcome|HP828-101|HP828-101 Experimental Formulation
354779|NCT01108523|O1|Outcome|HP828-101|HP828-101 Experimental Formulation
354780|NCT01108523|E1|Reported Event|HP828-101|HP828-101 Experimental Formulation
354781|NCT01108510|B3|Baseline|Total|Total of all reporting groups
354782|NCT01108510|B2|Baseline|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
354783|NCT01108510|B1|Baseline|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
354784|NCT01108510|P2|Participant Flow|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
354785|NCT01108510|P1|Participant Flow|ATV+COBI+FTC/TDF|Cobicistat (COBI) 150 mg + ritonavir (RTV) placebo + atazanavir (ATV) 300 mg + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) once daily
354786|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
354787|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
354788|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
354789|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
354790|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
354791|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
354792|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
354793|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
354794|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
354795|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
354796|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
354797|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
354798|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
354799|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
354800|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
354801|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
354802|NCT01108510|E2|Reported Event|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
354803|NCT01108510|E1|Reported Event|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
354804|NCT01108458|B1|Baseline|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks~Erlotinib hydrochloride 150 mg/day by mouth~Pertuzumab: iv, 840 mg, 420 mg~Erlotinib: PO, 150 mg"
354805|NCT01108458|P1|Participant Flow|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks~Erlotinib hydrochloride 150 mg/day by mouth~Pertuzumab: iv, 840 mg, 420 mg~Erlotinib: PO, 150 mg"
354806|NCT01108458|O1|Outcome|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks~Erlotinib hydrochloride 150 mg/day by mouth~Pertuzumab: iv, 840 mg, 420 mg~Erlotinib: PO, 150 mg"
355062|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
354807|NCT01108458|O1|Outcome|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks~Erlotinib hydrochloride 150 mg/day by mouth~Pertuzumab: iv, 840 mg, 420 mg~Erlotinib: PO, 150 mg"
354808|NCT01108458|O1|Outcome|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks~Erlotinib hydrochloride 150 mg/day by mouth~Pertuzumab: iv, 840 mg, 420 mg~Erlotinib: PO, 150 mg"
354809|NCT01108458|O1|Outcome|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks~Erlotinib hydrochloride 150 mg/day by mouth~Pertuzumab: iv, 840 mg, 420 mg~Erlotinib: PO, 150 mg"
354810|NCT01108458|O1|Outcome|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks~Erlotinib hydrochloride 150 mg/day by mouth~Pertuzumab: iv, 840 mg, 420 mg~Erlotinib: PO, 150 mg"
354811|NCT01108458|O1|Outcome|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks~Erlotinib hydrochloride 150 mg/day by mouth~Pertuzumab: iv, 840 mg, 420 mg~Erlotinib: PO, 150 mg"
354812|NCT01108458|E1|Reported Event|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks~Erlotinib hydrochloride 150 mg/day by mouth~Pertuzumab: iv, 840 mg, 420 mg~Erlotinib: PO, 150 mg"
354813|NCT01108445|B3|Baseline|Total|Total of all reporting groups
354814|NCT01108445|B2|Baseline|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
354815|NCT01108445|B1|Baseline|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
354816|NCT01108445|P2|Participant Flow|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
354817|NCT01108445|P1|Participant Flow|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
354818|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
354819|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
354820|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
354821|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
354822|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
354823|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
354824|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
354825|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
354826|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
354827|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
354828|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
354829|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
354830|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
354831|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
354832|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
354833|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
354834|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
354835|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
354836|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
354837|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
354838|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
354839|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
354840|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
354841|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
354842|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
354843|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
354844|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
354845|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
354846|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
354847|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
354848|NCT01108445|E2|Reported Event|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
354849|NCT01108445|E1|Reported Event|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
354850|NCT01108406|B1|Baseline|Long Term Safety|Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure.
354851|NCT01108406|P1|Participant Flow|Sonitus SoundBite System|Long Term Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure.
354852|NCT01108406|O2|Outcome|Global Benefit APHAB Score Aided 6 Months|The Global Benefit APHAB at 6 months endpoint is the change in APHAB scores between the unaided score at the start of the study and the APHAB score after 6 months of therapy.The APHAB Questionnaire produces an overall Global score (GBL). The larger the APHAB benefit score the greater the benefit. A negative APHAB benefit score represents therapy resulting in a worse outcome than no therapy.
354853|NCT01108406|O1|Outcome|Global Benefit APHAB Score Aided 3 Months|The Global Benefit APHAB at 3 months endpoint is the change in APHAB scores between the unaided score at the start of the study and the APHAB score after 3 months of therapy.The APHAB Questionnaire produces an overall Global score (GBL). The larger the APHAB benefit score the greater the benefit. A negative APHAB benefit score represents therapy resulting in a worse outcome than no therapy.
354854|NCT01108406|O1|Outcome|Number of Participants Experiencing no Adverse Events|Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure. Dental measurements included periodontal measurements (bone loss, oral health, bleeding index, calculus, peridontal probing) at baseline compared to 6 months. Audiological included hearing evaluation and aided thresholds baseline compared to 6 months and medical compared medical and ear health baseline compared to 6 months.
354855|NCT01108406|E1|Reported Event|Long Term Safety|Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure.
354856|NCT01108341|B1|Baseline|Bendamustine and Ofatumumab|There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
354857|NCT01108341|P1|Participant Flow|Bendamustine and Ofatumumab|There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
354858|NCT01108341|O1|Outcome|Bendamustine and Ofatumumab|There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
354859|NCT01108341|O1|Outcome|Bendamustine and Ofatumumab|There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
354860|NCT01108341|E1|Reported Event|Bendamustine and Ofatumumab|There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
354861|NCT01108263|B3|Baseline|Total|Total of all reporting groups
354862|NCT01108263|B2|Baseline|INTEGRA Flowable on Wound & Injected Subcutaneously|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
354863|NCT01108263|B1|Baseline|Integra Flowable on Wound Bed|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
354864|NCT01108263|P2|Participant Flow|INTEGRA Flowable on Wound & Injected Subcutaneously|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
354865|NCT01108263|P1|Participant Flow|Integra Flowable on Wound Bed|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
354866|NCT01108263|O2|Outcome|INTEGRA Flowable on Wound & Injected Subcutaneously|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
354867|NCT01108263|O1|Outcome|Integra Flowable on Wound Bed|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
354868|NCT01108263|O2|Outcome|INTEGRA Flowable on Wound & Injected Subcutaneously|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
354869|NCT01108263|O1|Outcome|Integra Flowable on Wound Bed|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
354870|NCT01108263|E2|Reported Event|INTEGRA Flowable on Wound & Injected Subcutaneously|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
354871|NCT01108263|E1|Reported Event|Integra Flowable on Wound Bed|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
354872|NCT01108237|B3|Baseline|Total|Total of all reporting groups
354873|NCT01108237|B2|Baseline|Total Knee Arthroplasty With Conventional Instrumentation|Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
354874|NCT01108237|B1|Baseline|TruMatch™ Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions
354875|NCT01108237|P2|Participant Flow|Total Knee Arthroplasty With Conventional Instrumentation|Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
354876|NCT01108237|P1|Participant Flow|TruMatch™ Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions
354877|NCT01108237|O2|Outcome|Total Knee Arthroplasty With Conventional Instrumentation|Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
354878|NCT01108237|O1|Outcome|TruMatch™ Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions
354879|NCT01108237|E2|Reported Event|Total Knee Arthroplasty With Conventional Instrumentation|Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
354880|NCT01108237|E1|Reported Event|TruMatch™ Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions
354881|NCT01108185|B1|Baseline|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
354882|NCT01108185|P1|Participant Flow|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
354883|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
354884|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
355063|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
354885|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
354886|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
354887|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
354888|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
354889|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
354890|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
354891|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
354892|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
354893|NCT01108185|E1|Reported Event|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
354894|NCT01108081|B5|Baseline|Total|Total of all reporting groups
354895|NCT01108081|B4|Baseline|Combined Physical Activity/Diet|Combined physical activity and diet
354896|NCT01108081|B3|Baseline|Health Education|"Health education~Health education: Attention control intervention"
354897|NCT01108081|B2|Baseline|Diet|"Diet~Diet: Dietary weight loss"
354898|NCT01108081|B1|Baseline|Physical Activity|"Physical activity~Physical activity: Moderate-intensity physical activity"
354899|NCT01108081|P4|Participant Flow|Combined Physical Activity/Diet|Combined physical activity and diet
354900|NCT01108081|P3|Participant Flow|Health Education|"Health education~Health education: Attention control intervention"
354901|NCT01108081|P2|Participant Flow|Diet|"Diet~Diet: Dietary weight loss"
354902|NCT01108081|P1|Participant Flow|Physical Activity|"Physical activity~Physical activity: Moderate-intensity physical activity"
354903|NCT01108081|O4|Outcome|Combined Physical Activity/Diet|Combined physical activity and diet
354904|NCT01108081|O3|Outcome|Health Education|"Health education~Health education: Attention control intervention"
354905|NCT01108081|O2|Outcome|Diet|"Diet~Diet: Dietary weight loss"
354906|NCT01108081|O1|Outcome|Physical Activity|"Physical activity~Physical activity: Moderate-intensity physical activity"
354907|NCT01108081|O4|Outcome|Combined Physical Activity/Diet|Combined physical activity and diet
354908|NCT01108081|O3|Outcome|Health Education|"Health education~Health education: Attention control intervention"
354909|NCT01108081|O2|Outcome|Diet|"Diet~Diet: Dietary weight loss"
354910|NCT01108081|O1|Outcome|Physical Activity|"Physical activity~Physical activity: Moderate-intensity physical activity"
354911|NCT01108081|E4|Reported Event|Combined Physical Activity/Diet|Combined physical activity and diet
354912|NCT01108081|E3|Reported Event|Health Education|"Health education~Health education: Attention control intervention"
354913|NCT01108081|E2|Reported Event|Diet|"Diet~Diet: Dietary weight loss"
354914|NCT01108081|E1|Reported Event|Physical Activity|"Physical activity~Physical activity: Moderate-intensity physical activity"
354915|NCT01108068|B3|Baseline|Total|Total of all reporting groups
354916|NCT01108068|B2|Baseline|Unaffected Controls|Family members of patients with OPPG will have DXA and pQCT to compare to OPPG patients. These unaffected participants will not receive lithium.
354917|NCT01108068|B1|Baseline|Lithium|"patients with OPPG will be treated with lithium for 6 months~Lithium: lithium will be given for 6 months to patients with OPPG, starting at a low dose of 2.5 mg/kg daily, gradually increasing until a lithium blood level of 0.3-0.6 ng/dl is achieved."
354918|NCT01108068|P2|Participant Flow|Unaffected Controls|Family members of patients with OPPG will have DXA and pQCT to compare to OPPG patients. These unaffected participants will not receive lithium.
354919|NCT01108068|P1|Participant Flow|Lithium|"patients with OPPG will be treated with lithium for 6 months~Lithium: lithium will be given for 6 months to patients with OPPG, starting at a low dose of 2.5 mg/kg daily, gradually increasing until a lithium blood level of 0.3-0.6 ng/dl is achieved."
354920|NCT01108068|O1|Outcome|OPPG Rx With Lithium|Two participants who were treated with lithium and had pQCT done
354921|NCT01108068|O2|Outcome|Unaffected Controls|Family members of patients with OPPG will have DXA and pQCT to compare to OPPG patients. These unaffected participants will not receive lithium.
354922|NCT01108068|O1|Outcome|Lithium|"patients with OPPG will be treated with lithium for 6 months~Lithium: lithium will be given for 6 months to patients with OPPG, starting at a low dose of 2.5 mg/kg daily, gradually increasing until a lithium blood level of 0.3-0.6 ng/dl is achieved."
354923|NCT01108068|E2|Reported Event|Unaffected Controls|Family members of patients with OPPG will have DXA and pQCT to compare to OPPG patients. These unaffected participants will not receive lithium.
354924|NCT01108068|E1|Reported Event|Lithium|"patients with OPPG will be treated with lithium for 6 months~Lithium: lithium will be given for 6 months to patients with OPPG, starting at a low dose of 2.5 mg/kg daily, gradually increasing until a lithium blood level of 0.3-0.6 ng/dl is achieved."
354925|NCT01108055|B1|Baseline|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
354926|NCT01108055|P1|Participant Flow|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
354927|NCT01108055|O1|Outcome|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
354928|NCT01108055|O1|Outcome|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
354929|NCT01108055|O1|Outcome|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
354930|NCT01108055|O1|Outcome|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
354931|NCT01108055|O1|Outcome|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
354932|NCT01108055|E1|Reported Event|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
354933|NCT01108003|B3|Baseline|Total|Total of all reporting groups
354934|NCT01108003|B2|Baseline|Arm 2|"Patients receive mango juice alone.~Mango Juice: given orally"
354935|NCT01108003|B1|Baseline|Arm I|"Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.~broccoli sprout extract: Given orally~laboratory biomarker analysis: Correlative studies"
354936|NCT01108003|P2|Participant Flow|Arm 2|"Patients receive mango juice alone.~Mango Juice: given orally"
354937|NCT01108003|P1|Participant Flow|Arm I|"Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.~broccoli sprout extract: Given orally~laboratory biomarker analysis: Correlative studies"
354938|NCT01108003|O2|Outcome|Arm 2|"Patients receive mango juice alone.~Mango Juice: given orally"
354939|NCT01108003|O1|Outcome|Arm I|"Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.~broccoli sprout extract: Given orally~laboratory biomarker analysis: Correlative studies"
354940|NCT01108003|O2|Outcome|Arm 2|"Patients receive mango juice alone.~Mango Juice: given orally"
354941|NCT01108003|O1|Outcome|Arm I|"Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.~broccoli sprout extract: Given orally~laboratory biomarker analysis: Correlative studies"
354942|NCT01108003|E2|Reported Event|Arm 2|"Patients receive mango juice alone.~Mango Juice: given orally"
354943|NCT01108003|E1|Reported Event|Arm I|"Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.~broccoli sprout extract: Given orally~laboratory biomarker analysis: Correlative studies"
354944|NCT01107964|B3|Baseline|Total|Total of all reporting groups
354945|NCT01107964|B2|Baseline|Corn Oil Capsule|Placebo corn oil capsule: 1 gram by mouth 4 times daily for 45 days
354946|NCT01107964|B1|Baseline|Omega-3-acid Ethyl Esters|Oral Omega-3-acid ethyl esters: 1 gram capsule by mouth four times daily for 45 days
354947|NCT01107964|P2|Participant Flow|Corn Oil Capsule|Placebo corn oil capsule: 1 gram by mouth 4 times daily for 45 days
354948|NCT01107964|P1|Participant Flow|Omega-3-acid Ethyl Esters|Oral Omega-3-acid ethyl esters: 1 gram capsule by mouth four times daily for 45 days
354949|NCT01107964|O2|Outcome|Corn Oil Capsule|Placebo corn oil capsule: 1 gram by mouth 4 times daily for 45 days
354950|NCT01107964|O1|Outcome|Omega-3-acid Ethyl Esters|Oral Omega-3-acid ethyl esters: 1 gram capsule by mouth four times daily for 45 days
354951|NCT01107964|O2|Outcome|Corn Oil Capsule|Placebo corn oil capsule: 1 gram by mouth 4 times daily for 45 days
354952|NCT01107964|O1|Outcome|Omega-3-acid Ethyl Esters|Oral Omega-3-acid ethyl esters: 1 gram capsule by mouth four times daily for 45 days
354953|NCT01107964|O2|Outcome|Corn Oil Capsule|Placebo corn oil capsule: 1 gram by mouth 4 times daily for 45 days
354954|NCT01107964|O1|Outcome|Omega-3-acid Ethyl Esters|Oral Omega-3-acid ethyl esters: 1 gram capsule by mouth four times daily for 45 days
354955|NCT01107964|O2|Outcome|Corn Oil Capsule|Placebo corn oil capsule: 1 gram by mouth 4 times daily for 45 days
354956|NCT01107964|O1|Outcome|Omega-3-acid Ethyl Esters|Oral Omega-3-acid ethyl esters: 1 gram capsule by mouth four times daily for 45 days
354957|NCT01107964|E2|Reported Event|Corn Oil Capsule|Placebo corn oil capsule: 1 gram by mouth 4 times daily for 45 days
354958|NCT01107964|E1|Reported Event|Omega-3-acid Ethyl Esters|Oral Omega-3-acid ethyl esters: 1 gram capsule by mouth four times daily for 45 days
354959|NCT01107925|B5|Baseline|Total|Total of all reporting groups
354960|NCT01107925|B4|Baseline|Dose Sequence: Pras 10mg, Clop 75 mg, Pras 5mg (HBW)|Participants in the HBW group received 10 mg Pras during Study Period 1, followed by 5 mg Pras in Study Period 2, followed by 75 mg Clop in Study Period 3.
354961|NCT01107925|B3|Baseline|Dose Sequence: Pras 10mg, Pras 5mg, Clop 75 mg (HBW)|Participants in the higher body weight (HBW; ≥60 kg) group received 10 mg Pras during Study Period 1, followed by 5 mg Pras in Study Period 2, followed by 75 mg Clop in Study Period 3.
354962|NCT01107925|B2|Baseline|Dose Sequence: Pras 5mg, Clop 75 mg, Pras 10mg (LBW)|Participants in the LBW group received 5 mg Pras during Study Period 1, followed by 75 mg Clop in Study Period 2, and 10 mg Pras in Study Period 3.
354963|NCT01107925|B1|Baseline|Dose Sequence: Pras 5mg, Pras 10mg, Clop 75mg (LBW)|Participants in the low body weight (LBW; <60 kilograms [kg]) group received 5 milligrams (mg) of Prasugrel (Pras) during Study Period 1, followed by 10 mg Pras in Study Period 2, followed by 75 mg clopidogrel (Clop) in Study Period 3.
354964|NCT01107925|P6|Participant Flow|75 mg Clopidogrel (HBW)|Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
354965|NCT01107925|P5|Participant Flow|10 mg Prasugrel (HBW)|During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
355064|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
354966|NCT01107925|P4|Participant Flow|5 mg Prasugrel (HBW)|Participants in the higher body weight (HBW; ≥ 60 kg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
354967|NCT01107925|P3|Participant Flow|75 mg Clopidogrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3.
354968|NCT01107925|P2|Participant Flow|10 mg Prasugrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
354969|NCT01107925|P1|Participant Flow|5 mg Prasugrel (LBW)|During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
354970|NCT01107925|O6|Outcome|75 mg Clopidogrel (HBW)|Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either 5-mg prasugrel or the 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
354971|NCT01107925|O5|Outcome|10 mg Prasugrel (HBW)|During Study Period 1, participants in the (HBW; ≥ 60 kg) treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
354972|NCT01107925|O4|Outcome|5 mg Prasugrel (HBW)|Participants in the higher body weight (HBW; ≥ 60 kg)treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
354973|NCT01107925|O3|Outcome|75 mg Clopidogrel (LBW)|Participants in the LBW treatment sequence in Period 1 (on 5 mg prasugrel) were switched to either the 10-mg prasugrel or the 75-mg clopidogrel dose for Period 2 or Period 3.
354974|NCT01107925|O2|Outcome|10 mg Prasugrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
354975|NCT01107925|O1|Outcome|5 mg Prasugrel (LBW)|During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
354976|NCT01107925|O6|Outcome|Clopidogrel 75 mg (HBW)|Participants in the HBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
354977|NCT01107925|O5|Outcome|Prasugrel 10 mg (HBW)|During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
354978|NCT01107925|O4|Outcome|Prasugrel 5 mg (HBW)|Participants in the higher body weight (HBW; ≥ 60 kg)treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
354979|NCT01107925|O3|Outcome|Clopidogrel 75 mg (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
354980|NCT01107925|O2|Outcome|Prasugrel 10 mg (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
354981|NCT01107925|O1|Outcome|Prasugrel 5 mg (LBW)|During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
354982|NCT01107925|O6|Outcome|75 mg Clopidogrel (HBW)|Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 75-mg clopidogrel or 5-mg prasugrel dose during Study Period 2 or Study Period 3.
354983|NCT01107925|O5|Outcome|10 mg Prasugrel (HBW)|During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
354984|NCT01107925|O4|Outcome|5 mg Prasugrel (HBW)|Participants in the higher body weight (HBW; ≥ 60 kg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
354985|NCT01107925|O3|Outcome|75 mg Clopidogrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3.
354986|NCT01107925|O2|Outcome|10 mg Prasugrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
354987|NCT01107925|O1|Outcome|5 mg Prasugrel (LBW)|During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; (<60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
354988|NCT01107925|O6|Outcome|75 mg Clopidogrel (HBW)|Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 75-mg clopidogrel or 5-mg prasugrel dose either during Study Period 2 or Study Period 3.
354989|NCT01107925|O5|Outcome|10 mg Prasugrel (HBW)|During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
354990|NCT01107925|O4|Outcome|5 mg Prasugrel (HBW)|Participants in the higher body weight (HBW; ≥ 60 kg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
354991|NCT01107925|O3|Outcome|75 mg Clopidogrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3.
354992|NCT01107925|O2|Outcome|10 mg Prasugrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
354993|NCT01107925|O1|Outcome|5 mg Prasugrel (LBW)|During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
354994|NCT01107925|O2|Outcome|Prasugrel 10 mg (HBW)|Participants in the higher body weight (HBW; ≥60 kg) group received the 10-mg prasugrel dose in Study Period 1.
354995|NCT01107925|O1|Outcome|Prasugrel 5 mg (LBW)|Participants in the low body weight (LBW; <60 kilograms [kg]) group received the 5-milligram (mg) prasugrel dose in Study Period 1.
354996|NCT01107925|E6|Reported Event|75 mg Clopidogrel (HBW)|Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
354997|NCT01107925|E5|Reported Event|10 mg Prasugrel (HBW)|During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
354998|NCT01107925|E4|Reported Event|5 mg Prasugrel (HBW)|Participants in the higher body weight (HBW; ≥ 60 mg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
354999|NCT01107925|E3|Reported Event|75 mg Clopidogrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3.
355000|NCT01107925|E2|Reported Event|10 mg Prasugrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
355001|NCT01107925|E1|Reported Event|5 mg Prasugrel (LBW)|During Study Period 1, participants received 5 milligrams (mg) prasugrel for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
355002|NCT01107912|B5|Baseline|Total|Total of all reporting groups
355003|NCT01107912|B4|Baseline|Non-Elderly; Drug Sequence BCA|Participants (≥45 to <65 years of age) in this arm received study drug sequence BCA. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
355004|NCT01107912|B3|Baseline|Non-Elderly; Drug Sequence BAC|Participants (≥45 to <65 years of age) in this arm received study drug sequence BAC. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
355005|NCT01107912|B2|Baseline|Very Elderly; Drug Sequence ACB|Participants (≥75 years of age) in this arm received study drug sequence ACB. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
355006|NCT01107912|B1|Baseline|Very Elderly, Drug Sequence ABC|Participants (≥75 years of age) in this arm received study drug sequence ABC. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
355007|NCT01107912|P6|Participant Flow|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
355008|NCT01107912|P5|Participant Flow|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
355009|NCT01107912|P4|Participant Flow|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
355010|NCT01107912|P3|Participant Flow|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
355011|NCT01107912|P2|Participant Flow|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
355012|NCT01107912|P1|Participant Flow|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
355013|NCT01107912|O6|Outcome|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
355014|NCT01107912|O5|Outcome|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
355015|NCT01107912|O4|Outcome|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
355016|NCT01107912|O3|Outcome|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
355017|NCT01107912|O2|Outcome|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
355018|NCT01107912|O1|Outcome|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
355019|NCT01107912|O6|Outcome|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
355020|NCT01107912|O5|Outcome|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
355021|NCT01107912|O4|Outcome|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
355022|NCT01107912|O3|Outcome|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
355023|NCT01107912|O2|Outcome|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
355024|NCT01107912|O1|Outcome|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
355025|NCT01107912|O6|Outcome|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
355026|NCT01107912|O5|Outcome|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
355027|NCT01107912|O4|Outcome|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
355028|NCT01107912|O3|Outcome|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
355029|NCT01107912|O2|Outcome|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
355030|NCT01107912|O1|Outcome|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
355031|NCT01107912|O6|Outcome|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
355032|NCT01107912|O5|Outcome|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
355033|NCT01107912|O4|Outcome|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
355034|NCT01107912|O3|Outcome|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
355035|NCT01107912|O2|Outcome|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
355036|NCT01107912|O1|Outcome|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
355037|NCT01107912|O2|Outcome|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
355038|NCT01107912|O1|Outcome|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
355039|NCT01107912|E6|Reported Event|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
355040|NCT01107912|E5|Reported Event|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
355041|NCT01107912|E4|Reported Event|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
355042|NCT01107912|E3|Reported Event|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
355043|NCT01107912|E2|Reported Event|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
355044|NCT01107912|E1|Reported Event|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
355045|NCT01107899|B4|Baseline|Total|Total of all reporting groups
355046|NCT01107899|B3|Baseline|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
355047|NCT01107899|B2|Baseline|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
355048|NCT01107899|B1|Baseline|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
355049|NCT01107899|P3|Participant Flow|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
355050|NCT01107899|P2|Participant Flow|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
355051|NCT01107899|P1|Participant Flow|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
355052|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
355053|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
355054|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
355055|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
355056|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
355057|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
355058|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
355059|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
355060|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
355061|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
355065|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
355066|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
355067|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
355068|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
355069|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
355070|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
355071|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
355072|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
355073|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
355074|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
355075|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
355076|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
355077|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
355078|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
355079|NCT01107899|O1|Outcome|All Treatments|"Clopidogrel 600 mg taken orally, day one, single dose Prasugrel 30 and 60 mg taken orally, day one, single dose~All treatments were combined into one group."
355080|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
355081|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
355082|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
355083|NCT01107899|O2|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
355084|NCT01107899|O1|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
355085|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
355086|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
355087|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
355088|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
355089|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
355090|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
355091|NCT01107899|E3|Reported Event|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
355092|NCT01107899|E2|Reported Event|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
355093|NCT01107899|E1|Reported Event|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
355094|NCT01107886|B3|Baseline|Total|Total of all reporting groups
355095|NCT01107886|B2|Baseline|Placebo|Matching Placebo
355096|NCT01107886|B1|Baseline|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
355097|NCT01107886|P2|Participant Flow|Placebo|Matching Placebo
355098|NCT01107886|P1|Participant Flow|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
355099|NCT01107886|O2|Outcome|Placebo|Matching Placebo
355100|NCT01107886|O1|Outcome|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
355101|NCT01107886|O2|Outcome|Placebo|Matching Placebo
355102|NCT01107886|O1|Outcome|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
355103|NCT01107886|O2|Outcome|Placebo|Matching Placebo
355104|NCT01107886|O1|Outcome|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
355105|NCT01107886|E2|Reported Event|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
355106|NCT01107886|E1|Reported Event|Placebo|Matching Placebo
355107|NCT01107834|B3|Baseline|Total|Total of all reporting groups
355108|NCT01107834|B2|Baseline|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
355109|NCT01107834|B1|Baseline|Healthy Control|HIV-negative children born to healthy, HIV-negative women
355110|NCT01107834|P2|Participant Flow|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
355111|NCT01107834|P1|Participant Flow|Healthy Control|HIV-negative children born to healthy, HIV-negative women
355112|NCT01107834|O2|Outcome|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
355113|NCT01107834|O1|Outcome|Healthy Control|HIV-negative children born to healthy, HIV-negative women
355114|NCT01107834|O2|Outcome|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
355115|NCT01107834|O1|Outcome|Healthy Control|HIV-negative children born to healthy, HIV-negative women
355116|NCT01107834|O2|Outcome|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
355117|NCT01107834|O1|Outcome|Healthy Control|HIV-negative children born to healthy, HIV-negative women
355118|NCT01107834|O2|Outcome|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
355119|NCT01107834|O1|Outcome|Healthy Control|HIV-negative children born to healthy, HIV-negative women
355120|NCT01107834|O2|Outcome|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
355121|NCT01107834|O1|Outcome|Healthy Control|HIV-negative children born to healthy, HIV-negative women
355122|NCT01107834|O2|Outcome|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
355123|NCT01107834|O1|Outcome|Healthy Control|HIV-negative children born to healthy, HIV-negative women
355124|NCT01107834|E2|Reported Event|Exposed to HIV/HAART|"HIV-negative children exposed to HIV and HAART in utero~No adverse events"
355125|NCT01107834|E1|Reported Event|Healthy Control|"HIV-negative children born to healthy, HIV-negative women~No adverse events"
355126|NCT01107743|B1|Baseline|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355127|NCT01107743|P1|Participant Flow|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355128|NCT01107743|O2|Outcome|With Concomitant Drugs|Participants with Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355129|NCT01107743|O1|Outcome|Without Concomitant Drugs|Participants without Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355130|NCT01107743|O2|Outcome|With Complications|Participants with Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355131|NCT01107743|O1|Outcome|Without Complications|Participants without Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355132|NCT01107743|O2|Outcome|With Renal Dysfunction|Participants with Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355133|NCT01107743|O1|Outcome|Without Renal Dysfunction|Participants without Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355134|NCT01107743|O2|Outcome|With Hepatic Dysfunction|Participants with Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355135|NCT01107743|O1|Outcome|Without Hepatic Dysfunction|Participants without Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355136|NCT01107743|O6|Outcome|Type Ⅴ|Participants with expression type Ⅴ who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
355137|NCT01107743|O5|Outcome|Type Ⅳ|Participants with expression type Ⅳ who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355138|NCT01107743|O4|Outcome|Type Ⅲ|Participants with expression type Ⅲ who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355139|NCT01107743|O3|Outcome|Type Ⅱb|Participants with expression type Ⅱb who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355140|NCT01107743|O2|Outcome|Type Ⅱa|Participants with expression type Ⅱa who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355141|NCT01107743|O1|Outcome|Type Ⅰ|Participants with expression type Ⅰ who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355142|NCT01107743|O2|Outcome|>=65 Years|Participants with >=65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355143|NCT01107743|O1|Outcome|<65 Years|Participants with <65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355144|NCT01107743|O2|Outcome|Female|Female Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355145|NCT01107743|O1|Outcome|Male|Male Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355146|NCT01107743|O2|Outcome|With Concomitant Drugs|Participants with Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355147|NCT01107743|O1|Outcome|Without Concomitant Drugs|Participants without Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355148|NCT01107743|O2|Outcome|With Complications|Participants with Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355149|NCT01107743|O1|Outcome|Without Complications|Participants without Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355150|NCT01107743|O2|Outcome|With Renal Dysfunction|Participants with Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355151|NCT01107743|O1|Outcome|Without Renal Dysfunction|Participants without Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355152|NCT01107743|O2|Outcome|With Hepatic Dysfunction|Participants with Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355153|NCT01107743|O1|Outcome|Without Hepatic Dysfunction|Participants without Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355154|NCT01107743|O4|Outcome|Class4|Participants with Class4 Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355155|NCT01107743|O3|Outcome|Class3|Participants with Class3 Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355156|NCT01107743|O2|Outcome|Class2|Participants with Class2 Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355157|NCT01107743|O1|Outcome|Class1|Participants with Class1 Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355158|NCT01107743|O2|Outcome|>=65 Years|Participants with >=65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355159|NCT01107743|O1|Outcome|<65 Years|Participants with <65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355160|NCT01107743|O2|Outcome|Female|Female Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355161|NCT01107743|O1|Outcome|Male|Male Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355162|NCT01107743|O2|Outcome|With Concomitant Drugs|Participants with Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355163|NCT01107743|O1|Outcome|Without Concomitant Drugs|Participants without Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355164|NCT01107743|O2|Outcome|With Complications|Participants with Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355165|NCT01107743|O1|Outcome|Without Complications|Participants without Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355166|NCT01107743|O2|Outcome|With Renal Dysfunction|Participants with Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355167|NCT01107743|O1|Outcome|Without Renal Dysfunction|Participants without Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355168|NCT01107743|O2|Outcome|With Hepatic Dysfunction|Participants with Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355169|NCT01107743|O1|Outcome|Without Hepatic Dysfunction|Participants without Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355170|NCT01107743|O3|Outcome|ClassⅢ|Participants with Class Ⅲ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355171|NCT01107743|O2|Outcome|ClassⅡ|Participants with ClassⅡ Hypertension who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
355172|NCT01107743|O1|Outcome|ClassⅠ|Participants with ClassⅠ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355173|NCT01107743|O2|Outcome|>=65 Years|Participants with >=65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355174|NCT01107743|O1|Outcome|<65 Years|Participants with <65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355175|NCT01107743|O2|Outcome|Female|Female Participants who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
355176|NCT01107743|O1|Outcome|Male|Male Participants who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
355177|NCT01107743|O2|Outcome|With Concomitant Drugs|Participants with Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355178|NCT01107743|O1|Outcome|Without Concomitant Drugs|Participants without Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355179|NCT01107743|O2|Outcome|With Complications|Participants with Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355180|NCT01107743|O1|Outcome|Without Complications|Participants without Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355181|NCT01107743|O2|Outcome|With Renal Dysfunction|Participants with Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355182|NCT01107743|O1|Outcome|Without Renal Dysfunction|Participants without Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355183|NCT01107743|O2|Outcome|With Hepatic Dysfunction|Participants with Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355184|NCT01107743|O1|Outcome|Without Hepatic Dysfunction|Participants without Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355185|NCT01107743|O2|Outcome|With Familial Hypercholesterolemia|Participants with Familial Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355186|NCT01107743|O1|Outcome|Without Familial Hypercholesterolemia|Participants without Familial Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355187|NCT01107743|O6|Outcome|Type Ⅴ|Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
355188|NCT01107743|O5|Outcome|Type Ⅳ|Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355189|NCT01107743|O4|Outcome|Type Ⅲ|Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355190|NCT01107743|O3|Outcome|Type Ⅱb|Participants with expression type Ⅱb Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355191|NCT01107743|O2|Outcome|Type Ⅱa|Participants with expression type Ⅱa Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355192|NCT01107743|O1|Outcome|Type Ⅰ|Participants with expression type Ⅰ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355193|NCT01107743|O2|Outcome|With Hypercholesterolemia|Participants with Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355194|NCT01107743|O1|Outcome|Without Hypercholesterolemia|Participants without Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355195|NCT01107743|O2|Outcome|With Angina Pectoris|Participants with Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355196|NCT01107743|O1|Outcome|Without Angina Pectoris|Participants without Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355197|NCT01107743|O3|Outcome|ClassⅢ|Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355290|NCT01107457|O1|Outcome|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355198|NCT01107743|O2|Outcome|ClassⅡ|Participants with ClassⅡ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355199|NCT01107743|O1|Outcome|ClassⅠ|Participants with ClassⅠ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355200|NCT01107743|O2|Outcome|With Hypertension|Participants with Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355201|NCT01107743|O1|Outcome|Without Hypertension|Participants without Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355202|NCT01107743|O2|Outcome|>=65 Years|Participants with >=65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355203|NCT01107743|O1|Outcome|<65 Years|Participants with <65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355204|NCT01107743|O2|Outcome|Female|Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355205|NCT01107743|O1|Outcome|Male|Male participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355206|NCT01107743|O1|Outcome|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355207|NCT01107743|O1|Outcome|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355208|NCT01107743|O1|Outcome|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355209|NCT01107743|O1|Outcome|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355210|NCT01107743|O1|Outcome|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355211|NCT01107743|E1|Reported Event|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
355212|NCT01107730|B4|Baseline|Total|Total of all reporting groups
355213|NCT01107730|B3|Baseline|Placebo|Placebo: Placebo
355214|NCT01107730|B2|Baseline|Vitamin C|Vitamin C 2 days preoperatively and 4 days postoperatively
355215|NCT01107730|B1|Baseline|L-Carnitine|Carnitine 2 days preoperatively and 4 days postoperatively
355216|NCT01107730|P3|Participant Flow|Placebo|Placebo: Placebo
355217|NCT01107730|P2|Participant Flow|Vitamin C|VitC intravenously (2g/day [500mgX4] for 2 days prior to surgery, and postoperatively for 4 days
355218|NCT01107730|P1|Participant Flow|L-Carnitine|L-Carnitine intravenously (2 gr/day [1grX2] for 2 days prior to surgery, and postoperatively for 4 days
355219|NCT01107730|O3|Outcome|Placebo|Placebo: Placebo
355220|NCT01107730|O2|Outcome|Vitamin C|Vitamin C 2 days preoperatively and 4 days postoperatively
355221|NCT01107730|O1|Outcome|L-Carnitine|Carnitine 2 days preoperatively and 4 days postoperatively
355222|NCT01107730|E3|Reported Event|Placebo|Placebo: Placebo
355223|NCT01107730|E2|Reported Event|Vitamin C|"Vitamin C 2 days preoperatively and 4 days postoperatively~Vitamin C: Vitamin C 2 days preoperatively and 4 days postoperatively"
355224|NCT01107730|E1|Reported Event|L-Carnitine|"Carnitine 2 days preoperatively and 4 days postoperatively~Carnitine: Carnitine 2 days preoperatively and 4 days postoperatively"
355225|NCT01107535|B1|Baseline|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
355226|NCT01107535|P1|Participant Flow|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
355227|NCT01107535|O1|Outcome|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
355228|NCT01107535|O1|Outcome|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
355229|NCT01107535|O1|Outcome|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
355230|NCT01107535|O1|Outcome|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
356812|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
355231|NCT01107535|O1|Outcome|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
355232|NCT01107535|E1|Reported Event|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
355233|NCT01107457|B6|Baseline|Total|Total of all reporting groups
355234|NCT01107457|B5|Baseline|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.~Part B: (optional)~Administered 120 mg ixekizumab SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~Part C: (optional)~Administered 80 mg ixekizumab SC Q4W through week 344."
355235|NCT01107457|B4|Baseline|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.~Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~Part C: (optional)~80 mg ixekizumab given SC Q4W through week 344."
355236|NCT01107457|B3|Baseline|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.~Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~Part C: (optional)~80 mg ixekizumab given SC Q4W through week 344."
355237|NCT01107457|B2|Baseline|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.~Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~Part C: (optional)~80 mg ixekizumab given SC Q4W through week 344."
355238|NCT01107457|B1|Baseline|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.~Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~Part C: (optional)~80 mg ixekizumab given SC Q4W through week 344."
355239|NCT01107457|P6|Participant Flow|120 mg/80 mg Total Ixekizumab|"Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~Part C: (optional)~80 mg ixekizumab given SC Q4W through week 344."
355240|NCT01107457|P5|Participant Flow|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.~Part B: (optional)~Administered 120 mg ixekizumab SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~Part C: (optional)~Administered 80 mg ixekizumab SC Q4W through week 344."
355241|NCT01107457|P4|Participant Flow|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.~Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~Part C: (optional)~80 mg ixekizumab given SC Q4W through week 344."
355242|NCT01107457|P3|Participant Flow|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.~Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~Part C: (optional)~80 mg ixekizumab given SC Q4W through week 344."
355243|NCT01107457|P2|Participant Flow|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.~Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~Part C: (optional)~80 mg ixekizumab given SC Q4W through week 344."
355244|NCT01107457|P1|Participant Flow|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.~Part B: (optional)~120 milligrams (mg) ixekizumab given subcutaneous (SC) every 4 weeks (Q4W). Subsequent to an amendment on May 2012, administration changed to 80 mg every 4 weeks through Week 236.~Part C: (optional)~80 mg ixekizumab given SC Q4W through week 344."
355245|NCT01107457|O1|Outcome|Total Ixekizumab (80 mg and 120 mg)|"Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC"
355246|NCT01107457|O1|Outcome|Total Ixekizumab (80 mg and 120 mg)|"Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC"
355247|NCT01107457|O1|Outcome|Total Ixekizumab (80 mg and 120 mg)|"Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC"
355248|NCT01107457|O1|Outcome|Total Ixekizumab (80 mg and 120 mg)|"Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC"
355249|NCT01107457|O1|Outcome|Total Ixekizumab (80 mg and 120 mg)|"Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC"
355250|NCT01107457|O1|Outcome|Total Ixekizumab (80 mg and 120 mg)|"Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC"
355291|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355251|NCT01107457|O1|Outcome|Total Ixekizumab (80 mg and 120 mg)|"Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC"
355252|NCT01107457|O1|Outcome|Total Ixekizumab (80 mg and 120 mg)|"Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC"
355253|NCT01107457|O1|Outcome|Total Ixekizumab (80 mg and 120 mg)|"Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC"
355254|NCT01107457|O1|Outcome|Total Ixekizumab (80 mg and 120 mg)|"Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.~During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC."
355255|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355256|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355257|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355258|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355259|NCT01107457|O1|Outcome|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355260|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355261|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355262|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355263|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355264|NCT01107457|O1|Outcome|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355265|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355266|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355267|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355268|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355269|NCT01107457|O1|Outcome|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355270|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355271|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355272|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355273|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355274|NCT01107457|O1|Outcome|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355275|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355276|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355277|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355278|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355279|NCT01107457|O1|Outcome|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355280|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355281|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355282|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355283|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355284|NCT01107457|O1|Outcome|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355285|NCT01107457|O1|Outcome|All Participants (10mg, 25mg,75mg & 150 mg Ixekizumab)|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355286|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355287|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355288|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355289|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
356813|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
355292|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355293|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355294|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355295|NCT01107457|O1|Outcome|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355296|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355297|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355298|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355299|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355300|NCT01107457|O1|Outcome|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355301|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355302|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355303|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355304|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355305|NCT01107457|O1|Outcome|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355306|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355307|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355308|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355309|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355310|NCT01107457|O1|Outcome|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355311|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355312|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355313|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355314|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355315|NCT01107457|O1|Outcome|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355316|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355317|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355318|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355319|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355320|NCT01107457|O1|Outcome|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355321|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355322|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355323|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355324|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355325|NCT01107457|O1|Outcome|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355326|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355327|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355328|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355329|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355330|NCT01107457|O1|Outcome|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355331|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355332|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355333|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355334|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355335|NCT01107457|O1|Outcome|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355336|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355337|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
356814|NCT01104584|O1|Outcome|CMRM vs UMRM|
355338|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355339|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355340|NCT01107457|O1|Outcome|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355341|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355342|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355343|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355344|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355345|NCT01107457|O1|Outcome|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355346|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355347|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355348|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355349|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355350|NCT01107457|O1|Outcome|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355351|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355352|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355353|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355354|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355355|NCT01107457|O1|Outcome|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355356|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355357|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355358|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355359|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355360|NCT01107457|O1|Outcome|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355361|NCT01107457|E8|Reported Event|Post Treatment Safety Visits|Participants who were followed due to neutropenia.
355362|NCT01107457|E7|Reported Event|120 mg and 80 mg Total Ixekizumab|"Part B: (optional)~120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236."
355363|NCT01107457|E6|Reported Event|Treatment Durability|Part A: Treatment durability/safety follow-up period:12 to 20 weeks.
355364|NCT01107457|E5|Reported Event|150 mg Ixekizumab|"Part A:~150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355365|NCT01107457|E4|Reported Event|75 mg Ixekizumab|"Part A:~75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355366|NCT01107457|E3|Reported Event|25 mg Ixekizumab|"Part A:~25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355367|NCT01107457|E2|Reported Event|10 mg Ixekizumab|"Part A:~10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355368|NCT01107457|E1|Reported Event|Placebo|"Part A:~Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
355369|NCT01107418|B5|Baseline|Total|Total of all reporting groups
355370|NCT01107418|B4|Baseline|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355371|NCT01107418|B3|Baseline|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355372|NCT01107418|B2|Baseline|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355373|NCT01107418|B1|Baseline|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355374|NCT01107418|P1|Participant Flow|Vemurafenib – All Cohorts|Participants received vemurafenib (RO5185426) film-coated tablets, orally, twice daily at doses of 240, 480, 720, or 960 milligrams (mg) on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355375|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355376|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355377|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355378|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355379|NCT01107418|O1|Outcome|Vemurafenib – All Cohorts|Participants received vemurafenib film-coated tablets, orally, twice daily at doses of 240, 480, 720, or 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355380|NCT01107418|O1|Outcome|Vemurafenib – All Cohorts|Participants received vemurafenib film-coated tablets, orally, twice daily at doses of 240, 480, 720, or 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355381|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355382|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355383|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355384|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355385|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355386|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355387|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355388|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355389|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355390|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
356815|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
355391|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355392|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355393|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355394|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355395|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355396|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355397|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355398|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355399|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355400|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355401|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355402|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355403|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355404|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355405|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355406|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
356205|NCT01105975|O10|Outcome|100 mg LY2484595 + 10 mg Rosuvastatin|Administered daily by mouth for 12 weeks
355407|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355408|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355409|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355410|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355411|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355412|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355413|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355414|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355415|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355416|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355417|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355418|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355419|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355420|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355421|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355422|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
356206|NCT01105975|O9|Outcome|10 mg Rosuvastatin Monotherapy|Administered daily by mouth for 12 weeks
355423|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355424|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355425|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355426|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355427|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355428|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355429|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355430|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355431|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355432|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355433|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355434|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355435|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355436|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355437|NCT01107418|E4|Reported Event|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355438|NCT01107418|E3|Reported Event|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
356207|NCT01105975|O8|Outcome|100 mg LY2484595 + 40 mg Simvastatin|Administered daily by mouth for 12 weeks
355439|NCT01107418|E2|Reported Event|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355440|NCT01107418|E1|Reported Event|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
355441|NCT01107405|B6|Baseline|Total|Total of all reporting groups
355442|NCT01107405|B5|Baseline|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
355443|NCT01107405|B4|Baseline|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
355444|NCT01107405|B3|Baseline|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
355445|NCT01107405|B2|Baseline|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
355446|NCT01107405|B1|Baseline|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
355447|NCT01107405|P5|Participant Flow|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
355448|NCT01107405|P4|Participant Flow|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
355449|NCT01107405|P3|Participant Flow|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
355450|NCT01107405|P2|Participant Flow|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
355451|NCT01107405|P1|Participant Flow|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
355452|NCT01107405|O5|Outcome|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
355453|NCT01107405|O4|Outcome|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
355454|NCT01107405|O3|Outcome|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
355455|NCT01107405|O2|Outcome|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
355456|NCT01107405|O1|Outcome|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
355457|NCT01107405|O5|Outcome|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
355458|NCT01107405|O4|Outcome|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
355459|NCT01107405|O3|Outcome|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
355460|NCT01107405|O2|Outcome|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
355461|NCT01107405|O1|Outcome|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
355462|NCT01107405|O5|Outcome|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
355463|NCT01107405|O4|Outcome|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
355464|NCT01107405|O3|Outcome|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
355465|NCT01107405|O2|Outcome|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
355466|NCT01107405|O1|Outcome|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
355467|NCT01107405|O5|Outcome|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
355468|NCT01107405|O4|Outcome|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
355469|NCT01107405|O3|Outcome|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
355470|NCT01107405|O2|Outcome|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
355471|NCT01107405|O1|Outcome|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
355472|NCT01107405|O5|Outcome|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
355473|NCT01107405|O4|Outcome|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
355474|NCT01107405|O3|Outcome|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
355475|NCT01107405|O2|Outcome|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
355476|NCT01107405|O1|Outcome|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
355477|NCT01107405|O5|Outcome|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
355478|NCT01107405|O4|Outcome|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
355479|NCT01107405|O3|Outcome|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
355480|NCT01107405|O2|Outcome|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
355481|NCT01107405|O1|Outcome|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
355482|NCT01107405|E5|Reported Event|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
355483|NCT01107405|E4|Reported Event|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
355484|NCT01107405|E3|Reported Event|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
355485|NCT01107405|E2|Reported Event|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
355486|NCT01107405|E1|Reported Event|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
355487|NCT01107392|B3|Baseline|Total|Total of all reporting groups
355488|NCT01107392|B2|Baseline|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
355489|NCT01107392|B1|Baseline|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
355490|NCT01107392|P2|Participant Flow|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
355491|NCT01107392|P1|Participant Flow|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
355492|NCT01107392|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
355493|NCT01107392|O1|Outcome|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
355494|NCT01107392|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
355495|NCT01107392|O1|Outcome|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
355496|NCT01107392|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
355497|NCT01107392|O1|Outcome|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
355498|NCT01107392|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
355499|NCT01107392|O1|Outcome|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
355500|NCT01107392|E2|Reported Event|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
355501|NCT01107392|E1|Reported Event|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
355502|NCT01107379|B1|Baseline|Balloon Catheter Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for sinus dilation"
355503|NCT01107379|P1|Participant Flow|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
355504|NCT01107379|O1|Outcome|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
355505|NCT01107379|O1|Outcome|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
355506|NCT01107379|O1|Outcome|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
355507|NCT01107379|O1|Outcome|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
355508|NCT01107379|O1|Outcome|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
355509|NCT01107379|O1|Outcome|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
355510|NCT01107379|E1|Reported Event|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
355511|NCT01107353|B3|Baseline|Total|Total of all reporting groups
355512|NCT01107353|B2|Baseline|First Tofranil PM, Then Imipramine Pamoate|"First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
355513|NCT01107353|B1|Baseline|First Imipramine Pamoate, Then Tofranil-PM|"First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
355514|NCT01107353|P2|Participant Flow|First Tofranil PM, Then Imipramine Pamoate|"First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
355515|NCT01107353|P1|Participant Flow|First Imipramine Pamoate, Then Tofranil-PM|"First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
355516|NCT01107353|O2|Outcome|First Tofranil PM, Then Imipramine Pamoate|"First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
355517|NCT01107353|O1|Outcome|First Imipramine Pamoate, Then Tofranil-PM|"First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
355518|NCT01107353|E2|Reported Event|First Tofranil PM, Then Imipramine Pamoate|"First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
355519|NCT01107353|E1|Reported Event|First Imipramine Pamoate, Then Tofranil-PM|"First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
355520|NCT01107197|B3|Baseline|Total|Total of all reporting groups
355521|NCT01107197|B2|Baseline|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
355522|NCT01107197|B1|Baseline|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
355523|NCT01107197|P2|Participant Flow|Enriched Nutrition Formula|"Patients were given standard diet plus two bottles/day (400 mL) of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements for 8 weeks~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
355524|NCT01107197|P1|Participant Flow|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bottles/day (200 mL each; in 4 boluses [100 mL each] spread throughout the day) of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one for 8 weeks~Control formula : Isonitrogenous isocaloric oral formula"
355627|NCT01106846|E1|Reported Event|Group A: Saline Group|"Group A: Saline group , infusion of saline intravenously~Group A: Saline Group: Saline continuous infusion"
355525|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
355526|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
355527|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
355528|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
355529|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
355530|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
355531|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
355532|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
355533|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
355534|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
355535|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
355536|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
355537|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
355538|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
355539|NCT01107197|E2|Reported Event|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
355540|NCT01107197|E1|Reported Event|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
355541|NCT01107015|B5|Baseline|Total|Total of all reporting groups
355542|NCT01107015|B4|Baseline|Group 4: Data Analyzed Intervention|"Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback; Physician can access raw and analyzed patient data; Physician receives report summary and treatment recommendations~Patient and PCP intervention with analyzed data:Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. PCPs are provided access to a secure web portal where they can see their patients' electro"
355543|NCT01107015|B3|Baseline|Group 3: Patient-physician Intervention|"Home diabetes monitoring by patient using mobile phone to communicate and receive feedback; Physician can access unanalyzed information from the patient's electronic logbook~Patient-physician intervention: . Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. PCPs are provided access to a web portal. This is raw patient data that have not been analyzed."
355544|NCT01107015|B2|Baseline|Group 2: Patient Intervention|"Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback~Tailored Patient Intervention: Patients enter bg data, carbohydrates consumed, diabetes medications taken. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. Patients may provide their PCPs with printed copies of their logbooks and other information but physicians do not have access to the patient portal system. Patient action plans summarizing the patient-entered data and identifying possible self-management actions for improving their diabetes control are electronically sent to the patients every 2.5 months."
355545|NCT01107015|B1|Baseline|Group 1: Usual Care|Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
355546|NCT01107015|P4|Participant Flow|Group 4: Data Analyzed Intervention|"Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback; Physician can access raw and analyzed patient data; Physician receives report summary and treatment recommendations~Patient and PCP intervention with analyzed data: Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. PCPs are provided access to a secure web portal where they can see their patients' electro"
355628|NCT01106690|B4|Baseline|Total|Total of all reporting groups
356208|NCT01105975|O7|Outcome|40 mg Simvastatin Monotherapy|Administered daily by mouth for 12 weeks
355547|NCT01107015|P3|Participant Flow|Group 3: Patient-physician Intervention|"Home diabetes monitoring by patient using mobile phone to communicate and receive feedback; Physician can access unanalyzed information from the patient's electronic logbook~PCPs are provided access to a web portal where they may choose to review their patients' electronic logbooks. This is raw patient data that have not be"
355548|NCT01107015|P2|Participant Flow|Group 2: Patient Intervention|"Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback~Patients may provide their PCPs with printed copies of their logbooks and other information but physicians do not have access to the patient portal system. Patient action plans summarizing the patient-entered data and identif"
355549|NCT01107015|P1|Participant Flow|Group 1: Usual Care|Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
355550|NCT01107015|O4|Outcome|Group 4: Data Analyzed Intervention|"Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback; Physician can access raw and analyzed patient data; Physician receives report summary and treatment recommendations~Patient and PCP intervention with analyzed data: Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. PCPs are provided access to a secure web portal where they can see their patients' electronic logbooks. PCPs are provided with data analysis reports. The PCP is reminded that all data analysis is based on patient-entered, unvalidated data. The PCP has the option to use this information and remains responsible for all treatment decisions."
355551|NCT01107015|O3|Outcome|Group 3: Patient-physician Intervention|"Home diabetes monitoring by patient using mobile phone to communicate and receive feedback; Physician can access unanalyzed information from the patient's electronic logbook~Patient-physician intervention: Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. PCPs are provided access to a web portal where they may choose to review their patients' electronic logbooks. This is raw patient data that have not been analyzed."
355552|NCT01107015|O2|Outcome|Group 2: Patient Intervention|"Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback~Tailored Patient Intervention: Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. Patients may provide their PCPs with printed copies of their logbooks and other information but physicians do not have access to the patient portal system. Patient action plans summarizing the patient-entered data and identifying possible self-management actions for improving their diabetes control are electronically sent to the patients every 2.5 months."
355553|NCT01107015|O1|Outcome|Group 1: Usual Care|Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
355554|NCT01107015|E4|Reported Event|Group 4: Data Analyzed Intervention|"Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback; Physician can access raw and analyzed patient data; Physician receives report summary and treatment recommendations~Patient and PCP intervention with analyzed data: Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. PCPs are provided access to a secure web portal where they can see their patients' electronic logbooks. PCPs are provided with data analysis reports. The PCP is reminded that all data analysis is based on patient-entered, unvalidated data. The PCP has the option to use this information and remains responsible for all treatment decisions."
355555|NCT01107015|E3|Reported Event|Group 3: Patient-physician Intervention|"Home diabetes monitoring by patient using mobile phone to communicate and receive feedback; Physician can access unanalyzed information from the patient's electronic logbook~Patient-physician intervention: Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. PCPs are provided access to a web portal where they may choose to review their patients' electronic logbooks. This is raw patient data that have not been analyzed."
355556|NCT01107015|E2|Reported Event|Group 2: Patient Intervention|"Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback~Tailored Patient Intervention: Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. Patients may provide their PCPs with printed copies of their logbooks and other information but physicians do not have access to the patient portal system. Patient action plans summarizing the patient-entered data and identifying possible self-management actions for improving their diabetes control are electronically sent to the patients every 2.5 months."
355557|NCT01107015|E1|Reported Event|Group 1: Usual Care|Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
355558|NCT01106976|B1|Baseline|Group 1 Parkinson Disease Subjects|Prospective cohort study. 59 PD patients
355559|NCT01106976|P1|Participant Flow|Group 1 Parkinson Disease Subjects|Prospective cohort study. 59 PD patients; Hoehn and Yahr stage 1-3) underwent [C-11]methyl-4-piperidinyl propionate (PMP) acetylcholinesterase (AChE) brain PET imaging at baseline and at 3-4 year follow-up. AChE PET imaging assesses cholinergic terminal integrity with cortical uptake reflecting largely basal forebrain neuron integrity and thalamic uptake principally reflecting pedunculopontine nucleus integrity.
355560|NCT01106976|O1|Outcome|Parkinson Disease|Prospective cohort study of Parkinson disease subjects.
355561|NCT01106976|E1|Reported Event|Parkinson|Longitudinal cohort
355562|NCT01106950|B1|Baseline|Evaluable (Treated) Patients|Patients are treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
355563|NCT01106950|P1|Participant Flow|Evaluable (Treated) Patients|Patients with acute myeloid leukemia (AML) are treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
355564|NCT01106950|O2|Outcome|Evaluable (Treated) Patients (Expansion=Yes)|KIR mismatched: Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
355565|NCT01106950|O1|Outcome|Evaluable (Treated) Patients (Expansion=No)|KIR matched: Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
355566|NCT01106950|O1|Outcome|Evaluable (Treated) Patients|Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
355567|NCT01106950|O1|Outcome|Evaluable (Treated) Patients|Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
355568|NCT01106950|O1|Outcome|Evaluable (Treated) Patients|Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
355569|NCT01106950|O1|Outcome|Evaluable (Treated) Patients|Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
355570|NCT01106950|O1|Outcome|Evaluable (Treated) Patients|Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
355571|NCT01106950|E1|Reported Event|Treated Patients|Patients with acute myeloid leukemia (AML) are treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
355572|NCT01106911|B1|Baseline|Digital Breast Tomosynthesis (DBT)|Consented and eligible women undergoing baseline screening mammography received DBT
355573|NCT01106911|P1|Participant Flow|Digital Breast Tomosynthesis (DBT)|Consented and eligible women undergoing baseline screening mammography received DBT
355574|NCT01106911|O1|Outcome|Digital Breast Tomosynthesis (DBT)|Consented and eligible women undergoing baseline screening mammography received DBT
355575|NCT01106911|E1|Reported Event|Digital Breast Tomosynthesis (DBT)|Consented and eligible women undergoing baseline screening mammography received DBT
355576|NCT01106898|B1|Baseline|Treatment (Chemotherapy With or Without Maintenance Therapy)|"SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY (Her-2 neu positive patients): Patients receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for 14 courses in the absence of disease progression or unacceptable toxicity.~cyclophosphamide, paclitaxel, trastuzumab: Given IV"
355577|NCT01106898|P1|Participant Flow|Treatment (Chemotherapy With or Without Maintenance Therapy)|"SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY (Her-2 neu positive patients): Patients receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for 14 courses in the absence of disease progression or unacceptable toxicity.~cyclophosphamide, paclitaxel, trastuzumab: Given IV"
355578|NCT01106898|O1|Outcome|Treatment (Chemotherapy With or Without Maintenance Therapy)|"SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY (Her-2 neu positive patients): Patients receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for 14 courses in the absence of disease progression or unacceptable toxicity.~cyclophosphamide, paclitaxel, trastuzumab: Given IV"
355579|NCT01106898|E1|Reported Event|Treatment (Chemotherapy With or Without Maintenance Therapy)|"SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY (Her-2 neu positive patients): Patients receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for 14 courses in the absence of disease progression or unacceptable toxicity.~cyclophosphamide, paclitaxel, trastuzumab: Given IV"
355580|NCT01106859|B1|Baseline|Total Population|All participants in this four-way cross-over study
355581|NCT01106859|P1|Participant Flow|Total Population|All participants in this four-way cross-over study
355582|NCT01106859|O4|Outcome|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
355583|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
355584|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
355585|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
355586|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
355587|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
355588|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
355589|NCT01106859|O4|Outcome|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
355590|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
355591|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
355592|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
355593|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
355594|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
355595|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
355596|NCT01106859|O4|Outcome|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
355597|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
355598|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
355599|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
355600|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
355601|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
355602|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
355603|NCT01106859|O4|Outcome|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
355604|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
355605|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
355606|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
355607|NCT01106859|O4|Outcome|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
355608|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
355609|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
355610|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
355611|NCT01106859|O4|Outcome|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
355612|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
355613|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
355614|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
355615|NCT01106859|E4|Reported Event|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
355616|NCT01106859|E3|Reported Event|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
355617|NCT01106859|E2|Reported Event|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
355618|NCT01106859|E1|Reported Event|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
355619|NCT01106846|B3|Baseline|Total|Total of all reporting groups
355620|NCT01106846|B2|Baseline|Group B: 1% Ketamine Group|"Group B: Infusion of ketamine 1% intravenously~Group B: 1% Ketamine group: Administration of 1% ketamine intravenously."
355621|NCT01106846|B1|Baseline|Group A: Saline Group|"Group A: Saline group , infusion of saline intravenously~Group A: Saline Group: Saline continuous infusion"
355622|NCT01106846|P2|Participant Flow|Group B: 1% Ketamine Group|"Group B: Infusion of ketamine 1% intravenously~Group B: 1% Ketamine group: Administration of 1% ketamine intravenously."
355623|NCT01106846|P1|Participant Flow|Group A: Saline Group|"Group A: Saline group , infusion of saline intravenously~Group A: Saline Group: Saline continuous infusion"
355624|NCT01106846|O2|Outcome|Group B: 1% Ketamine Group|"Group B: Infusion of ketamine 1% intravenously~Group B: 1% Ketamine group: Administration of 1% ketamine intravenously."
355625|NCT01106846|O1|Outcome|Group A: Saline Group|"Group A: Saline group , infusion of saline intravenously~Group A: Saline Group: Saline continuous infusion"
355626|NCT01106846|E2|Reported Event|Group B: 1% Ketamine Group|"Group B: Infusion of ketamine 1% intravenously~Group B: 1% Ketamine group: Administration of 1% ketamine intravenously."
356209|NCT01105975|O6|Outcome|100 mg LY2484595 + 20 mg Atorvastatin|Administered daily by mouth for 12 weeks
355629|NCT01106690|B3|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
355630|NCT01106690|B2|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
355631|NCT01106690|B1|Baseline|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
355632|NCT01106690|P3|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
355633|NCT01106690|P2|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
355634|NCT01106690|P1|Participant Flow|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
355635|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
355636|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
355637|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
355638|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
355639|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
355640|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
355641|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
355642|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
355643|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
355644|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
355645|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
355646|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
355647|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
355648|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
355649|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
355650|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
355651|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
355652|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
355653|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
355654|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
355655|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
355656|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
355657|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
355658|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
355659|NCT01106690|E6|Reported Event|Canagliflozin 300 mg: Baseline to Week 52|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 52.
355660|NCT01106690|E5|Reported Event|Canagliflozin 100 mg: Baseline to Week 52|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 52.
355759|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355661|NCT01106690|E4|Reported Event|Placebo/Sitagliptin: Baseline to Week 52|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52. Data are presented for Baseline to Week 52.
355662|NCT01106690|E3|Reported Event|Canagliflozin 300 mg: Baseline to Week 26|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 26.
355663|NCT01106690|E2|Reported Event|Canagliflozin 100 mg: Baseline to Week 26|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 26.
355664|NCT01106690|E1|Reported Event|Placebo/Sitagliptin: Baseline to Week 26|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52. Data are presented for Baseline to Week 26.
355665|NCT01106677|B5|Baseline|Total|Total of all reporting groups
355666|NCT01106677|B4|Baseline|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355667|NCT01106677|B3|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355668|NCT01106677|B2|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355669|NCT01106677|B1|Baseline|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
355670|NCT01106677|P4|Participant Flow|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355671|NCT01106677|P3|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355672|NCT01106677|P2|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355673|NCT01106677|P1|Participant Flow|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
355674|NCT01106677|O3|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355675|NCT01106677|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355676|NCT01106677|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355677|NCT01106677|O3|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355678|NCT01106677|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355679|NCT01106677|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355680|NCT01106677|O3|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355681|NCT01106677|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355682|NCT01106677|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355683|NCT01106677|O3|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355684|NCT01106677|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355685|NCT01106677|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355686|NCT01106677|O3|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355687|NCT01106677|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355688|NCT01106677|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355689|NCT01106677|O3|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355690|NCT01106677|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355691|NCT01106677|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355692|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355693|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355694|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355793|NCT01106625|P1|Participant Flow|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355695|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
355696|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355697|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355698|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355699|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
355700|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355701|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355702|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355703|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
355704|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355705|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355706|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355707|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
355708|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355709|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355710|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355711|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
355712|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355713|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355714|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355715|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
355716|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355717|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355718|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355719|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
355720|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355721|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355722|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
355723|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
355724|NCT01106677|E8|Reported Event|Sitagliptin 100mg: Baseline to Week 52|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
355725|NCT01106677|E7|Reported Event|Canagliflozin 300 mg: Baseline to Week 52|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
355726|NCT01106677|E6|Reported Event|Canagliflozin 100 mg: Baseline to Week 52|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
355833|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
355727|NCT01106677|E5|Reported Event|Placebo/Sitagliptin: Baseline to Week 52|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
355728|NCT01106677|E4|Reported Event|Sitagliptin 100 mg: Baseline to Week 26|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
355729|NCT01106677|E3|Reported Event|Canagliflozin 300 mg: Baseline to Week 26|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
355730|NCT01106677|E2|Reported Event|Canagliflozin 100 mg: Baseline to Week 26|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
355731|NCT01106677|E1|Reported Event|Placebo/Sitagliptin: Baseline to Week 26|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
355732|NCT01106651|B4|Baseline|Total|Total of all reporting groups
355733|NCT01106651|B3|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355734|NCT01106651|B2|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355735|NCT01106651|B1|Baseline|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355736|NCT01106651|P3|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355737|NCT01106651|P2|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355738|NCT01106651|P1|Participant Flow|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355739|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355740|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355741|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355742|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355743|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355744|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355745|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355746|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355747|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355748|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355749|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355750|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355751|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355752|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355753|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355754|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355755|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355756|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355757|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355758|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
356210|NCT01105975|O5|Outcome|20 mg Atorvastatin Monotherapy|Administered daily by mouth for 12 weeks
355760|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355761|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355762|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355763|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355764|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355765|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355766|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355767|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355768|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355769|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355770|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355771|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355772|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355773|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355774|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355775|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355776|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355777|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355778|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355779|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355780|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
355781|NCT01106651|E6|Reported Event|Canagliflozin 300 mg: Baseline to Week 104|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 104
355782|NCT01106651|E5|Reported Event|Canagliflozin 100 mg: Baseline to Week 104|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 104
355783|NCT01106651|E4|Reported Event|Placebo: Baseline to Week 104|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 104.
355784|NCT01106651|E3|Reported Event|Canagliflozin 300 mg: Baseline to Week 26|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 26.
355785|NCT01106651|E2|Reported Event|Canagliflozin 100 mg: Baseline to Week 26|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 26.
355786|NCT01106651|E1|Reported Event|Placebo: Baseline to Week 26|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 26.
355787|NCT01106625|B4|Baseline|Total|Total of all reporting groups
355788|NCT01106625|B3|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355789|NCT01106625|B2|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355790|NCT01106625|B1|Baseline|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355791|NCT01106625|P3|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355792|NCT01106625|P2|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355794|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355795|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355796|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355797|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355798|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355799|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355800|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355801|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355802|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355803|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355804|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355805|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355806|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355807|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355808|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355809|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355810|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355811|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355812|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355813|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355814|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
355815|NCT01106625|E6|Reported Event|Canagliflozin 300 mg: Baseline to Week 52|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 52.
355816|NCT01106625|E5|Reported Event|Canagliflozin 100 mg: Baseline to Week 52|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 52.
355817|NCT01106625|E4|Reported Event|Placebo: Baseline to Week 52|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 52.
355818|NCT01106625|E3|Reported Event|Canagliflozin 300 mg: Baseline to Week 26|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 26.
355819|NCT01106625|E2|Reported Event|Canagliflozin 100 mg: Baseline to Week 26|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 26.
355820|NCT01106625|E1|Reported Event|Placebo: Baseline to Week 26|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 26.
355821|NCT01106586|B3|Baseline|Total|Total of all reporting groups
355822|NCT01106586|B2|Baseline|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
355823|NCT01106586|B1|Baseline|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
355824|NCT01106586|P2|Participant Flow|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
355825|NCT01106586|P1|Participant Flow|Stribild|Stribild® (elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg) plus placebo to match atazanavir/ritonavir (ATV/r) + FTC/TDF once daily
355826|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
355827|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
355828|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
355829|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
355830|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
355831|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
355832|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
355834|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
355835|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
355836|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
355837|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
355838|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
355839|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
355840|NCT01106586|E2|Reported Event|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
355841|NCT01106586|E1|Reported Event|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
355842|NCT01106534|B1|Baseline|Second Enrollment Phase of XIENCE V® USA|"Additional 3000 patients recruited in the second enrollment phase treated with the XIENCE V EECSS who are free from events (death, MI, repeat coronary revascularization, stroke, ST, or major bleeding - severe or moderate by GUSTO classification) in the first year after the index procedure, and are compliant with DAPT will be identified as prospective patients for the AV-DAPT cohort. A total of 870 Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized at 12 months post index procedure to 18 months of either active treatment with thienopyridines or placebo. Clinical follow-up will occur at 15, 24, 30 and 33 months. These patients will be followed by Abbott Vascular."
355843|NCT01106534|P1|Participant Flow|Second Enrollment Phase of XIENCE V® USA|"Additional 3000 patients recruited in the second enrollment phase treated with the XIENCE V EECSS who are free from events (death, MI, repeat coronary revascularization, stroke, ST, or major bleeding - severe or moderate by GUSTO classification) in the first year after the index procedure, and are compliant with DAPT will be identified as prospective patients for the AV-DAPT cohort. A total of 870 Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized at 12 months post index procedure to 18 months of either active treatment with thienopyridines or placebo. Clinical follow-up will occur at 15, 24, 30 and 33 months. These patients will be followed by Abbott Vascular."
355844|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
355845|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
355846|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
355847|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
355848|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
355849|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
355850|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
355851|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
355852|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
355853|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
355854|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
355855|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
355856|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
355857|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
355858|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
355859|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
355860|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
355861|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
355862|NCT01106534|E1|Reported Event|Second Enrollment Phase of XIENCE V® USA|The participants enrolled in this study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.
355863|NCT01106456|B3|Baseline|Total|Total of all reporting groups
355864|NCT01106456|B2|Baseline|Nontailored Program (NT)|All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the Nontailored program (NT).
355865|NCT01106456|B1|Baseline|All Nations Breath of Life Program (ANBL)|"All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the culturally-tailored All Nations Breath of Life program (ANBL)"
355866|NCT01106456|P2|Participant Flow|Nontailored Program (NT)|All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the Nontailored program (NT).
355867|NCT01106456|P1|Participant Flow|All Nations Breath of Life Program (ANBL)|"All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the culturally-tailored All Nations Breath of Life program (ANBL)"
355868|NCT01106456|O2|Outcome|Nontailored Program (NT)|All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the Nontailored program (NT).
355869|NCT01106456|O1|Outcome|All Nations Breath of Life Program (ANBL)|"All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the culturally-tailored All Nations Breath of Life program (ANBL)."
355870|NCT01106456|E2|Reported Event|Experimental 2: Nontailored Program (NT)|"All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into either the culturally-tailored All Nations Breath of Life program (ANBL) or Nontailored program (NT).~Experimental 2: Nontailored program (NT): The nontailored intervention includes the medicines listed above to all participants and targeted counseling delivered by non-American Indian counselors who have worked closely with the American Indian communities and respect the cultures, values, and traditions of the Indian people. Therefore, our intervention includes the current best practice recommendations for smoking cessation. At six months and 12 months post baseline, all participants will be assessed for smoking status and smoking abstinence.~Pharmacotherapy (e.g. Varenicline or Bupropion or NRT): Pharmacotherapy (e.g. Varenicline or Bupropion or NRT)"
355871|NCT01106456|E1|Reported Event|Experimental 1: All Nations Breath of Life Program (ANBL)|"All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into either the culturally-tailored All Nations Breath of Life program (ANBL) or Nontailored program (NT).~Experimental 1: All Nations Breath of Life program (ANBL): ANBL consists of in-person group sessions and individual telephone calls. We have successfully conducted a pilot study of ANBL and have found very promising results. At six months and 12 months post baseline, all participants will be assessed for smoking status and smoking abstinence.~Pharmacotherapy (e.g. Varenicline or Bupropion or NRT): Pharmacotherapy (e.g. Varenicline or Bupropion or NRT)"
355872|NCT01106430|B3|Baseline|Total|Total of all reporting groups
355873|NCT01106430|B2|Baseline|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
355874|NCT01106430|B1|Baseline|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
355875|NCT01106430|P2|Participant Flow|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
355876|NCT01106430|P1|Participant Flow|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
355877|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
355878|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
355879|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
355880|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
355881|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
355882|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
355883|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
355884|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
355885|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
355886|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
355887|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
355888|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
355889|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
355890|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
355891|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
355892|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
355893|NCT01106430|E2|Reported Event|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
355894|NCT01106430|E1|Reported Event|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
355895|NCT01106404|B3|Baseline|Total|Total of all reporting groups
356816|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
355896|NCT01106404|B2|Baseline|6-week Manual Followed by 6-week AdaptiveStim Programming|Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.
355897|NCT01106404|B1|Baseline|6-week AdaptiveStim Followed by 6-week Manual Programming|Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.
355898|NCT01106404|P2|Participant Flow|6-week Manual Followed by 6-week AdaptiveStim Programming|Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.
355899|NCT01106404|P1|Participant Flow|6-week AdaptiveStim Followed by 6-week Manual Programming|Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.
355900|NCT01106404|O4|Outcome|NPRS at 16 Weeks Post-implant|Included subjects with NPRS scores from both baseline and 16 weeks post-implant
355901|NCT01106404|O3|Outcome|NPRS at Baseline (Subject With Score at 16 Weeks Post-implant)|Included subjects with NPRS scores from both baseline and 16 weeks post-implant
355902|NCT01106404|O2|Outcome|NPRS at 10 Weeks Post-implant|Included subjects with NPRS scores from both baseline and 10 weeks post-implant
355903|NCT01106404|O1|Outcome|NPRS at Baseline (Subject With Score at 10 Weeks Post-implant)|Included subjects with NPRS scores from both baseline and 10 weeks post-implant
355904|NCT01106404|O2|Outcome|Manual Treatment Arm|Subjects in manual treatment arm received programming provided by the RestoreSensor neurostimulator with AdaptiveStim OFF.
355905|NCT01106404|O1|Outcome|AdaptiveStim Treatment Arm|Subjects in AdaptiveStim treatment arm received programming provided by the RestoreSensor neurostimulator with AdaptiveStim ON.
355906|NCT01106404|O2|Outcome|6-week Manual Followed by 6-week AdaptiveStime Programming|Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.
355907|NCT01106404|O1|Outcome|6-week AdaptiveStim Followed by 6-week Manual Programming|Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.
355908|NCT01106404|O2|Outcome|6-week Manual Followed by 6-week AdaptiveStim Programming|Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.
355909|NCT01106404|O1|Outcome|6-week AdaptiveStim Followed by 6-week Manual Programming|Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.
355910|NCT01106404|E1|Reported Event|Overall Adverse Events|Overall adverse events were reported.
355911|NCT01106391|B1|Baseline|The INCRAFT™ AAA Stent-graft System|The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.
355912|NCT01106391|P1|Participant Flow|The INCRAFT™ AAA Stent-graft System|The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.
355913|NCT01106391|O1|Outcome|The INCRAFT™ AAA Stent-graft System|The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.
355914|NCT01106391|O1|Outcome|The INCRAFT™ AAA Stent-graft System|The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.
355915|NCT01106391|E1|Reported Event|The INCRAFT™ AAA Stent-graft System|The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.
355916|NCT01106352|B6|Baseline|Total|Total of all reporting groups
355917|NCT01106352|B5|Baseline|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
355918|NCT01106352|B4|Baseline|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
355919|NCT01106352|B3|Baseline|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
355920|NCT01106352|B2|Baseline|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
355921|NCT01106352|B1|Baseline|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
355922|NCT01106352|P5|Participant Flow|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
356211|NCT01105975|O4|Outcome|Placebo|Administered daily by mouth for 12 weeks
355923|NCT01106352|P4|Participant Flow|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
355924|NCT01106352|P3|Participant Flow|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
355925|NCT01106352|P2|Participant Flow|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
355926|NCT01106352|P1|Participant Flow|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
355927|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
355928|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
355929|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
355930|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
355931|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
355932|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
355933|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
355934|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
355935|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
355936|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
355937|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
355938|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
355939|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
355940|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
355941|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
355942|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
355943|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
355944|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
355945|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
355946|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
355947|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
355948|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
356212|NCT01105975|O3|Outcome|500 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
355949|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
355950|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
355951|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
355952|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
355953|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
355954|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
355955|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
355956|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
355957|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
355958|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
355959|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
355960|NCT01106352|O3|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
355961|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
355962|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
355963|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
355964|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
355965|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
355966|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
355967|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
355968|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
355969|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
356055|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
355970|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
355971|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
355972|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
355973|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
355974|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
355975|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
355976|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
355977|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
355978|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
355979|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
355980|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
355981|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
355982|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
355983|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
355984|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
355985|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
355986|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
355987|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
355988|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
355989|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
355990|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
356213|NCT01105975|O2|Outcome|100 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356214|NCT01105975|O1|Outcome|30 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
355991|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
355992|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
355993|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
355994|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
355995|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
355996|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
355997|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
355998|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
355999|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
356000|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
356001|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
356002|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
356003|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
356004|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
356005|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
356006|NCT01106352|E5|Reported Event|Docetaxel 75 mg/m^2 - Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks
356007|NCT01106352|E4|Reported Event|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
356008|NCT01106352|E3|Reported Event|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
356009|NCT01106352|E2|Reported Event|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
356010|NCT01106352|E1|Reported Event|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on National Institute of Standards and Technology (NIST) 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 milligram per square meter (mg/m^2) every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation
356215|NCT01105975|O10|Outcome|100 mg LY2484595 + 10 mg Rosuvastatin|Administered daily by mouth for 12 weeks
356216|NCT01105975|O9|Outcome|10 mg Rosuvastatin Monotherapy|Administered daily by mouth for 12 weeks
356011|NCT01106326|B1|Baseline|Intervention|"Teens participating in this study will have:~directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study~three counseling sessions with a study nurse trained in principles of motivational interviewing (MI), that are designed to enhance the teen’s motivation to change health behaviors, with a focus on adherence to evidence-based preventive care guidelines (e.g.; preventive medications)."
356012|NCT01106326|P1|Participant Flow|Intervention|"Teens participating in this study will have:~directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study~three counseling sessions with a study nurse trained in principles of motivational interviewing (MI), that are designed to enhance the teen’s motivation to change health behaviors, with a focus on adherence to evidence-based preventive care guidelines (e.g.; preventive medications)."
356013|NCT01106326|O3|Outcome|Four Months Post Baseline|
356014|NCT01106326|O2|Outcome|Two Months Post Baseline|
356015|NCT01106326|O1|Outcome|Baseline|
356016|NCT01106326|E1|Reported Event|Intervention|"Teens participating in this study will have:~directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study~three counseling sessions with a study nurse trained in principles of motivational interviewing (MI), that are designed to enhance the teen’s motivation to change health behaviors, with a focus on adherence to evidence-based preventive care guidelines (e.g.; preventive medications)."
356017|NCT01106287|B5|Baseline|Total|Total of all reporting groups
356018|NCT01106287|B4|Baseline|Pbo/MK-0941 80/100 mg/Pbo/MK-0941 140 mg|Treatment Sequence 4
356019|NCT01106287|B3|Baseline|MK-0941 60 mg/Pbo/MK-0941 100/120/140 mg|Treatment Sequence 3
356020|NCT01106287|B2|Baseline|MK-0941 60/80/Pbo/ MK-0941 120/140 mg|Treatment Sequence 2
356021|NCT01106287|B1|Baseline|MK-0941 60/80/100/120 mg/Pbo|Treatment Sequence 1
356022|NCT01106287|P4|Participant Flow|Pbo/MK-0941 80/100 mg/Pbo/MK-0941 140 mg|Treatment Sequence 4
356023|NCT01106287|P3|Participant Flow|MK-0941 60 mg/Pbo/MK-0941 100/120/140 mg|Treatment Sequence 3
356024|NCT01106287|P2|Participant Flow|MK-0941 60/80 mg/Pbo/MK-0941 120/140 mg|Treatment Sequence 2
356025|NCT01106287|P1|Participant Flow|MK-0941 60/80/100/120 mg/Pbo|Treatment Sequence 1
356026|NCT01106287|O6|Outcome|Placebo|All participants receiving placebo
356027|NCT01106287|O5|Outcome|MK-0941 140 mg|All participants receiving a 140-mg dose of MK-0941
356028|NCT01106287|O4|Outcome|MK-0941 120 mg|All participants receiving a 120-mg dose of MK-0941
356029|NCT01106287|O3|Outcome|MK-0941 100 mg|All participants receiving a 100-mg dose of MK-0941
356030|NCT01106287|O2|Outcome|MK-0941 80 mg|All participants receiving a 80-mg dose of MK-0941
356031|NCT01106287|O1|Outcome|MK-0941 60 mg|All participants receiving a 60-mg dose of MK-0941
356032|NCT01106287|O6|Outcome|Placebo|All participants receiving placebo
356033|NCT01106287|O5|Outcome|MK-0941 140 mg|All participants receiving a 140-mg dose of MK-0941
356034|NCT01106287|O4|Outcome|MK-0941 120 mg|All participants receiving a 120-mg dose of MK-0941
356035|NCT01106287|O3|Outcome|MK-0941 100 mg|All participants receiving a 100-mg dose of MK-0941
356036|NCT01106287|O2|Outcome|MK-0941 80 mg|All participants receiving a 80-mg dose of MK-0941
356037|NCT01106287|O1|Outcome|MK-0941 60 mg|All participants receiving a 60-mg dose of MK-0941
356038|NCT01106287|E6|Reported Event|Placebo|All participants receiving placebo
356039|NCT01106287|E5|Reported Event|MK-0941 140 mg|All participants receiving at least one dose of 140 mg of MK-0941
356040|NCT01106287|E4|Reported Event|MK-0941 120 mg|All participants receiving at least one dose of 120 mg of MK-0941
356041|NCT01106287|E3|Reported Event|MK-0941 100 mg|All participants receiving at least one dose of 100 mg of MK-0941
356042|NCT01106287|E2|Reported Event|MK-0941 80 mg|All participants receiving at least one dose of 80 mg of MK-0941
356043|NCT01106287|E1|Reported Event|MK-0941 60 mg|All participants receiving at least one dose of 60 mg of MK-0941
356044|NCT01106248|B1|Baseline|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
356045|NCT01106248|P1|Participant Flow|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
356046|NCT01106248|O1|Outcome|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
356047|NCT01106248|O1|Outcome|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
356048|NCT01106248|O1|Outcome|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
356049|NCT01106248|E1|Reported Event|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
356050|NCT01106157|B3|Baseline|Total|Total of all reporting groups
356051|NCT01106157|B2|Baseline|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
356052|NCT01106157|B1|Baseline|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
356053|NCT01106157|P2|Participant Flow|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner.~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes."
356054|NCT01106157|P1|Participant Flow|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose) given subcutaneously every 2 weeks beginning after the ATG infusion."
356056|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
356057|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
356058|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
356059|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
356060|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
356061|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
356062|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
356063|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
356064|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
356065|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
356066|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
356067|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
356068|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
356069|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
356070|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
356071|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
356072|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
356073|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
356093|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356074|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
356075|NCT01106157|E2|Reported Event|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
356076|NCT01106157|E1|Reported Event|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
356077|NCT01106092|B5|Baseline|Total|Total of all reporting groups
356078|NCT01106092|B4|Baseline|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
356079|NCT01106092|B3|Baseline|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356080|NCT01106092|B2|Baseline|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356081|NCT01106092|B1|Baseline|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356082|NCT01106092|P4|Participant Flow|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
356083|NCT01106092|P3|Participant Flow|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356084|NCT01106092|P2|Participant Flow|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356085|NCT01106092|P1|Participant Flow|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356086|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
356087|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356088|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356089|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356090|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
356091|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356092|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356203|NCT01105975|P2|Participant Flow|100 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356204|NCT01105975|P1|Participant Flow|30 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356094|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
356095|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356096|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356097|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356098|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
356099|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356100|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356101|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356102|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
356103|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356104|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356105|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356106|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
356107|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356108|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356109|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356110|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
356111|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356112|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356113|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356114|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
356115|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356116|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356117|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356118|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
356119|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356120|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356121|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356122|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
356123|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356124|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356125|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356126|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
356127|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356128|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356129|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356130|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
356131|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356132|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356133|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356134|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
356135|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356136|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356137|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356138|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
356139|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356140|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356141|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356142|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
356143|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356144|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356145|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356146|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
356147|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356148|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356149|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356150|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
356151|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356152|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356153|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356154|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
356155|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356156|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356157|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356158|NCT01106092|E4|Reported Event|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
356159|NCT01106092|E3|Reported Event|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356160|NCT01106092|E2|Reported Event|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356161|NCT01106092|E1|Reported Event|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
356162|NCT01106040|B1|Baseline|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
356163|NCT01106040|P1|Participant Flow|Lymphoseek, Lymphatic Mapping, Injection|Melanoma and breast cancer patients to receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
356164|NCT01106040|O1|Outcome|Reverse Intent-To-Treat|Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
356165|NCT01106040|O1|Outcome|Intent-To-Treat|Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
356166|NCT01106040|E1|Reported Event|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
356167|NCT01106027|B1|Baseline|Eculizumab|"Patients will be given 1200 mg of eculizumab intravenously over 30 minutes, 1 hour prior to surgery. Patients will be given 900 mg of eculizumab on Day 1 post-transplant. Patients will then be given 900 mg of eculizumab weekly through 4 weeks post-transplant.~At week 4, patients will be assessed for donor specific anti-donor human leukocyte antigen (HLA) antibody (DSA). Patients with total DSA normalized values <5000 will stop eculizumab treatment. Patients with total DSA normalized values >5000 will continue eculizumab treatment every 14 days from week 5 through week 9. The dose will be increased to 1200 mg and dosing will now be every 2 weeks instead of weekly."
356168|NCT01106027|P1|Participant Flow|Eculizumab|"Patients will be given 1200 mg of eculizumab intravenously over 30 minutes, 1 hour prior to surgery. Patients will be given 900 mg of eculizumab on Day 1 post-transplant. Patients will then be given 900 mg of eculizumab weekly through 4 weeks post-transplant.~At week 4, patients will be assessed for donor specific anti-donor human leukocyte antigen (HLA) antibody (DSA). Patients with total DSA normalized values <5000 will stop eculizumab treatment. Patients with total DSA normalized values >5000 will continue eculizumab treatment every 14 days from week 5 through week 9. The dose will be increased to 1200 mg and dosing will now be every 2 weeks instead of weekly."
356169|NCT01106027|O1|Outcome|Eculizumab|"Patients will be given 1200 mg of eculizumab intravenously over 30 minutes, 1 hour prior to surgery. Patients will be given 900 mg of eculizumab on Day 1 post-transplant. Patients will then be given 900 mg of eculizumab weekly through 4 weeks post-transplant.~At week 4, patients will be assessed for donor specific anti-donor human leukocyte antigen (HLA) antibody (DSA). Patients with total DSA normalized values <5000 will stop eculizumab treatment. Patients with total DSA normalized values >5000 will continue eculizumab treatment every 14 days from week 5 through week 9. The dose will be increased to 1200 mg and dosing will now be every 2 weeks instead of weekly."
356374|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
356170|NCT01106027|E1|Reported Event|Eculizumab|"Patients will be given 1200 mg of eculizumab intravenously over 30 minutes, 1 hour prior to surgery. Patients will be given 900 mg of eculizumab on Day 1 post-transplant. Patients will then be given 900 mg of eculizumab weekly through 4 weeks post-transplant.~At week 4, patients will be assessed for donor specific anti-donor human leukocyte antigen (HLA) antibody (DSA). Patients with total DSA normalized values <5000 will stop eculizumab treatment. Patients with total DSA normalized values >5000 will continue eculizumab treatment every 14 days from week 5 through week 9. The dose will be increased to 1200 mg and dosing will now be every 2 weeks instead of weekly."
356171|NCT01106014|B3|Baseline|Total|Total of all reporting groups
356172|NCT01106014|B2|Baseline|Placebo|Matching placebo was administered orally following the same administration schedule as described for selexipag
356173|NCT01106014|B1|Baseline|Selexipag|During the 12-week titration phase, treatment was initiated at 200 μg twice daily (b.i.d.) and up-titrated weekly in 200 μg b.i.d. increments to the maximum tolerated dose (MTD) for each individual patient but not above 1600 μg b.i.d. At Week 12, patients continued the treatment at their individual MTD up to Week 26. Thereafter the dose could be up-titrated at scheduled visits if needed for patients receiving a dose &lt; 1600 μg b.i.d. The dose could be decreased at any time in case of tolerability issues.
356174|NCT01106014|P2|Participant Flow|PLACEBO|Matching placebo was administered orally following the same administration schedule as described for selexipag
356175|NCT01106014|P1|Participant Flow|SELEXIPAG|During the 12-week titration phase, treatment was initiated at 200 μg twice daily (b.i.d.) and up-titrated weekly in 200 μg b.i.d. increments to the maximum tolerated dose (MTD) for each individual patient but not above 1600 μg b.i.d. At Week 12, patients continued the treatment at their individual MTD up to Week 26. Thereafter the dose could be up-titrated at scheduled visits if needed for patients receiving a dose &lt; 1600 μg b.i.d. The dose could be decreased at any time in case of tolerability issues.
356176|NCT01106014|O2|Outcome|Placebo|Matching placebo was administered orally following the same administration schedule as described for selexipag
356177|NCT01106014|O1|Outcome|Selexipag|During the 12-week titration phase, treatment was initiated at 200 μg twice daily (b.i.d.) and up-titrated weekly in 200 μg b.i.d. increments to the maximum tolerated dose (MTD) for each individual patient but not above 1600 μg b.i.d. At Week 12, patients continued the treatment at their individual MTD up to Week 26. Thereafter the dose could be up-titrated at scheduled visits if needed for patients receiving a dose &lt; 1600 μg b.i.d. The dose could be decreased at any time in case of tolerability issues
356178|NCT01106014|O2|Outcome|Placebo|Matching placebo was administered orally following the same administration schedule as described for selexipag
356179|NCT01106014|O1|Outcome|Selexipag|During the 12-week titration phase, treatment was initiated at 200 μg twice daily (b.i.d.) and up-titrated weekly in 200 μg b.i.d. increments to the maximum tolerated dose (MTD) for each individual patient but not above 1600 μg b.i.d. At Week 12, patients continued the treatment at their individual MTD up to Week 26. Thereafter the dose could be up-titrated at scheduled visits if needed for patients receiving a dose &lt; 1600 μg b.i.d. The dose could be decreased at any time in case of tolerability issues
356180|NCT01106014|O2|Outcome|Placebo|Matching placebo was administered orally following the same administration schedule as described for selexipag
356181|NCT01106014|O1|Outcome|Selexipag|During the 12-week titration phase, treatment was initiated at 200 μg twice daily (b.i.d.) and up-titrated weekly in 200 μg b.i.d. increments to the maximum tolerated dose (MTD) for each individual patient but not above 1600 μg b.i.d. At Week 12, patients continued the treatment at their individual MTD up to Week 26. Thereafter the dose could be up-titrated at scheduled visits if needed for patients receiving a dose &lt; 1600 μg b.i.d. The dose could be decreased at any time in case of tolerability issues
356182|NCT01106014|E2|Reported Event|Placebo|This group includes patients who received at least one dose of placebo. Four patients who were randomized to placebo never received the drugs and another patient received selexipag by mistake (see Selexipag group for more details). Therefore, these patients were excluded from the placebo group in the safety analysis set.
356183|NCT01106014|E1|Reported Event|Selexipag|This group includes patients who received at least one dose of selexipag. One subject who was randomized to placebo received a single dose of 8 tablets of selexipag due to an error in the dispensation of the medication bottle. Therefore, this patient was assigned to the selexipag group in the safety analysis set.
356184|NCT01105975|B11|Baseline|Total|Total of all reporting groups
356185|NCT01105975|B10|Baseline|100 mg LY2484595 + 10 mg Rosuvastatin|Administered daily by mouth for 12 weeks
356186|NCT01105975|B9|Baseline|10 mg Rosuvastatin Monotherapy|Administered daily by mouth for 12 weeks
356187|NCT01105975|B8|Baseline|100 mg LY2484595 + 40 mg Simvastatin|Administered daily by mouth for 12 weeks
356188|NCT01105975|B7|Baseline|40 mg Simvastatin Monotherapy|Administered daily by mouth for 12 weeks
356189|NCT01105975|B6|Baseline|100 mg LY2484595 + 20 mg Atorvastatin|Administered daily by mouth for 12 weeks
356190|NCT01105975|B5|Baseline|20 mg Atorvastatin Monotherapy|Administered daily by mouth for 12 weeks
356191|NCT01105975|B4|Baseline|Placebo|Administered daily by mouth for 12 weeks
356192|NCT01105975|B3|Baseline|500 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356193|NCT01105975|B2|Baseline|100 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356194|NCT01105975|B1|Baseline|30 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356195|NCT01105975|P10|Participant Flow|100 mg LY2484595 + 10 mg Rosuvastatin|Administered daily by mouth for 12 weeks
356196|NCT01105975|P9|Participant Flow|10 mg Rosuvastatin Monotherapy|Administered daily by mouth for 12 weeks
356197|NCT01105975|P8|Participant Flow|100 mg LY2484595 + 40 mg Simvastatin|Administered daily by mouth for 12 weeks
356198|NCT01105975|P7|Participant Flow|40 mg Simvastatin Monotherapy|Administered daily by mouth for 12 weeks
356199|NCT01105975|P6|Participant Flow|100 mg LY2484595 + 20 mg Atorvastatin|Administered daily by mouth for 12 weeks
356200|NCT01105975|P5|Participant Flow|20 mg Atorvastatin Monotherapy|Administered daily by mouth for 12 weeks
356201|NCT01105975|P4|Participant Flow|Placebo|Administered daily by mouth for 12 weeks
356202|NCT01105975|P3|Participant Flow|500 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356817|NCT01104584|O1|Outcome|CMRM vs UMRM|
356217|NCT01105975|O8|Outcome|100 mg LY2484595 + 40 mg Simvastatin|Administered daily by mouth for 12 weeks
356218|NCT01105975|O7|Outcome|40 mg Simvastatin Monotherapy|Administered daily by mouth for 12 weeks
356219|NCT01105975|O6|Outcome|100 mg LY2484595 + 20 mg Atorvastatin|Administered daily by mouth for 12 weeks
356220|NCT01105975|O5|Outcome|20 mg Atorvastatin Monotherapy|Administered daily by mouth for 12 weeks
356221|NCT01105975|O4|Outcome|Placebo|Administered daily by mouth for 12 weeks
356222|NCT01105975|O3|Outcome|500 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356223|NCT01105975|O2|Outcome|100 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356224|NCT01105975|O1|Outcome|30 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356225|NCT01105975|O10|Outcome|100 mg LY2484595 + 10 mg Rosuvastatin|Administered daily by mouth for 12 weeks
356226|NCT01105975|O9|Outcome|10 mg Rosuvastatin Monotherapy|Administered daily by mouth for 12 weeks
356227|NCT01105975|O8|Outcome|100 mg LY2484595 + 40 mg Simvastatin|Administered daily by mouth for 12 weeks
356228|NCT01105975|O7|Outcome|40 mg Simvastatin Monotherapy|Administered daily by mouth for 12 weeks
356229|NCT01105975|O6|Outcome|100 mg LY2484595 + 20 mg Atorvastatin|Administered daily by mouth for 12 weeks
356230|NCT01105975|O5|Outcome|20 mg Atorvastatin Monotherapy|Administered daily by mouth for 12 weeks
356231|NCT01105975|O4|Outcome|Placebo|Administered daily by mouth for 12 weeks
356232|NCT01105975|O3|Outcome|500 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356233|NCT01105975|O2|Outcome|100 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356234|NCT01105975|O1|Outcome|30 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356235|NCT01105975|O10|Outcome|100 mg LY2484595 + 10 mg Rosuvastatin|Administered daily by mouth for 12 weeks
356236|NCT01105975|O9|Outcome|10 mg Rosuvastatin Monotherapy|Administered daily by mouth for 12 weeks
356237|NCT01105975|O8|Outcome|100 mg LY2484595 + 40 mg Simvastatin|Administered daily by mouth for 12 weeks
356238|NCT01105975|O7|Outcome|40 mg Simvastatin Monotherapy|Administered daily by mouth for 12 weeks
356239|NCT01105975|O6|Outcome|100 mg LY2484595 + 20 mg Atorvastatin|Administered daily by mouth for 12 weeks
356240|NCT01105975|O5|Outcome|20 mg Atorvastatin Monotherapy|Administered daily by mouth for 12 weeks
356241|NCT01105975|O4|Outcome|Placebo|Administered daily by mouth for 12 weeks
356242|NCT01105975|O3|Outcome|500 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356243|NCT01105975|O2|Outcome|100 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356244|NCT01105975|O1|Outcome|30 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356245|NCT01105975|O10|Outcome|100 mg LY2484595 + 10 mg Rosuvastatin|Administered daily by mouth for 12 weeks
356246|NCT01105975|O9|Outcome|10 mg Rosuvastatin Monotherapy|Administered daily by mouth for 12 weeks
356247|NCT01105975|O8|Outcome|100 mg LY2484595 + 40 mg Simvastatin|Administered daily by mouth for 12 weeks
356248|NCT01105975|O7|Outcome|40 mg Simvastatin Monotherapy|Administered daily by mouth for 12 weeks
356249|NCT01105975|O6|Outcome|100 mg LY2484595 + 20 mg Atorvastatin|Administered daily by mouth for 12 weeks
356250|NCT01105975|O5|Outcome|20 mg Atorvastatin Monotherapy|Administered daily by mouth for 12 weeks
356251|NCT01105975|O4|Outcome|Placebo|Administered daily by mouth for 12 weeks
356252|NCT01105975|O3|Outcome|500 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356253|NCT01105975|O2|Outcome|100 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356254|NCT01105975|O1|Outcome|30 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356255|NCT01105975|O10|Outcome|100 mg LY2484595 + 10 mg Rosuvastatin|Administered daily by mouth for 12 weeks
356256|NCT01105975|O9|Outcome|10 mg Rosuvastatin Monotherapy|Administered daily by mouth for 12 weeks
356257|NCT01105975|O8|Outcome|100 mg LY2484595 + 40 mg Simvastatin|Administered daily by mouth for 12 weeks
356258|NCT01105975|O7|Outcome|40 mg Simvastatin Monotherapy|Administered daily by mouth for 12 weeks
356259|NCT01105975|O6|Outcome|100 mg LY2484595 + 20 mg Atorvastatin|Administered daily by mouth for 12 weeks
356260|NCT01105975|O5|Outcome|20 mg Atorvastatin Monotherapy|Administered daily by mouth for 12 weeks
356261|NCT01105975|O4|Outcome|Placebo|Administered daily by mouth for 12 weeks
356262|NCT01105975|O3|Outcome|500 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356263|NCT01105975|O2|Outcome|100 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356264|NCT01105975|O1|Outcome|30 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356265|NCT01105975|O10|Outcome|100 mg LY2484595 + 10 mg Rosuvastatin|Administered daily by mouth for 12 weeks
356266|NCT01105975|O9|Outcome|10 mg Rosuvastatin Monotherapy|Administered daily by mouth for 12 weeks
356267|NCT01105975|O8|Outcome|100 mg LY2484595 + 40 mg Simvastatin|Administered daily by mouth for 12 weeks
356268|NCT01105975|O7|Outcome|40 mg Simvastatin Monotherapy|Administered daily by mouth for 12 weeks
356269|NCT01105975|O6|Outcome|100 mg LY2484595 + 20 mg Atorvastatin|Administered daily by mouth for 12 weeks
356270|NCT01105975|O5|Outcome|20 mg Atorvastatin Monotherapy|Administered daily by mouth for 12 weeks
356271|NCT01105975|O4|Outcome|Placebo|Administered daily by mouth for 12 weeks
356272|NCT01105975|O3|Outcome|500 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356273|NCT01105975|O2|Outcome|100 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356274|NCT01105975|O1|Outcome|30 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356275|NCT01105975|O10|Outcome|100 mg LY2484595 + 10 mg Rosuvastatin|Administered daily by mouth for 12 weeks
356276|NCT01105975|O9|Outcome|10 mg Rosuvastatin Monotherapy|Administered daily by mouth for 12 weeks
356277|NCT01105975|O8|Outcome|100 mg LY2484595 + 40 mg Simvastatin|Administered daily by mouth for 12 weeks
356278|NCT01105975|O7|Outcome|40 mg Simvastatin Monotherapy|Administered daily by mouth for 12 weeks
356279|NCT01105975|O6|Outcome|100 mg LY2484595 + 20 mg Atorvastatin|Administered daily by mouth for 12 weeks
356280|NCT01105975|O5|Outcome|20 mg Atorvastatin Monotherapy|Administered daily by mouth for 12 weeks
356281|NCT01105975|O4|Outcome|Placebo|Administered daily by mouth for 12 weeks
356282|NCT01105975|O3|Outcome|500 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356283|NCT01105975|O2|Outcome|100 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356284|NCT01105975|O1|Outcome|30 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356285|NCT01105975|O10|Outcome|100 mg LY2484595 + 10 mg Rosuvastatin|Administered daily by mouth for 12 weeks
356286|NCT01105975|O9|Outcome|10 mg Rosuvastatin Monotherapy|Administered daily by mouth for 12 weeks
356287|NCT01105975|O8|Outcome|100 mg LY2484595 + 40 mg Simvastatin|Administered daily by mouth for 12 weeks
356288|NCT01105975|O7|Outcome|40 mg Simvastatin Monotherapy|Administered daily by mouth for 12 weeks
356289|NCT01105975|O6|Outcome|100 mg LY2484595 + 20 mg Atorvastatin|Administered daily by mouth for 12 weeks
356290|NCT01105975|O5|Outcome|20 mg Atorvastatin Monotherapy|Administered daily by mouth for 12 weeks
356291|NCT01105975|O4|Outcome|Placebo|Administered daily by mouth for 12 weeks
356292|NCT01105975|O3|Outcome|500 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356293|NCT01105975|O2|Outcome|100 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356294|NCT01105975|O1|Outcome|30 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356295|NCT01105975|O10|Outcome|100 mg LY2484595 + 10 mg Rosuvastatin|Administered daily by mouth for 12 weeks
356296|NCT01105975|O9|Outcome|10 mg Rosuvastatin Monotherapy|Administered daily by mouth for 12 weeks
356297|NCT01105975|O8|Outcome|100 mg LY2484595 + 40 mg Simvastatin|Administered daily by mouth for 12 weeks
356298|NCT01105975|O7|Outcome|40 mg Simvastatin Monotherapy|Administered daily by mouth for 12 weeks
356299|NCT01105975|O6|Outcome|100 mg LY2484595 + 20 mg Atorvastatin|Administered daily by mouth for 12 weeks
356300|NCT01105975|O5|Outcome|20 mg Atorvastatin Monotherapy|Administered daily by mouth for 12 weeks
356301|NCT01105975|O4|Outcome|Placebo|Administered daily by mouth for 12 weeks
356302|NCT01105975|O3|Outcome|500 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356303|NCT01105975|O2|Outcome|100 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356304|NCT01105975|O1|Outcome|30 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356305|NCT01105975|O6|Outcome|100 mg LY2484595 + 10 mg Rosuvastatin|Administered daily by mouth for 12 weeks
356306|NCT01105975|O5|Outcome|100 mg LY2484595 + 40 mg Simvastatin|Administered daily by mouth for 12 weeks
356307|NCT01105975|O4|Outcome|100 mg LY2484595 + 20 mg Atorvastatin|Administered daily by mouth for 12 weeks
356308|NCT01105975|O3|Outcome|500 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356309|NCT01105975|O2|Outcome|100 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356310|NCT01105975|O1|Outcome|30 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356311|NCT01105975|O4|Outcome|100 mg LY2484595 + 10 mg Rosuvastatin|Administered daily by mouth for 12 weeks
356312|NCT01105975|O3|Outcome|10 mg Rosuvastatin Monotherapy|Administered daily by mouth for 12 weeks
356313|NCT01105975|O2|Outcome|100 mg LY2484595 + 40 mg Simvastatin|Administered daily by mouth for 12 weeks
356314|NCT01105975|O1|Outcome|40 mg Simvastatin Monotherapy|Administered daily by mouth for 12 weeks
356315|NCT01105975|O4|Outcome|100 mg LY2484595 + 10 mg Rosuvastatin|Administered daily by mouth for 12 weeks
356316|NCT01105975|O3|Outcome|10 mg Rosuvastatin Monotherapy|Administered daily by mouth for 12 weeks
356317|NCT01105975|O2|Outcome|100 mg LY2484595 + 40 mg Simvastatin|Administered daily by mouth for 12 weeks
356318|NCT01105975|O1|Outcome|40 mg Simvastatin Monotherapy|Administered daily by mouth for 12 weeks
356319|NCT01105975|O4|Outcome|Placebo|Administered daily by mouth for 12 weeks
356320|NCT01105975|O3|Outcome|500 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356321|NCT01105975|O2|Outcome|100 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356322|NCT01105975|O1|Outcome|30 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356323|NCT01105975|O4|Outcome|Placebo|Administered daily by mouth for 12 weeks
356324|NCT01105975|O3|Outcome|500 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356325|NCT01105975|O2|Outcome|100 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356326|NCT01105975|O1|Outcome|30 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356327|NCT01105975|O2|Outcome|100 mg LY2484595 + 20 mg Atorvastatin|Administered daily by mouth for 12 weeks
356328|NCT01105975|O1|Outcome|20 mg Atorvastatin Monotherapy|Administered daily by mouth for 12 weeks
356329|NCT01105975|O2|Outcome|100 mg LY2484595 + 20 mg Atorvastatin|Administered daily by mouth for 12 weeks
356330|NCT01105975|O1|Outcome|20 mg Atorvastatin Monotherapy|Administered daily by mouth for 12 weeks
356331|NCT01105975|E20|Reported Event|100 mg LY2484595 + 10 mg Rosuvastatin Follow-Up|30 day follow-up period after last dose of study drug
356332|NCT01105975|E19|Reported Event|10 mg Rosuvastatin Monotherapy Follow-Up|30 day follow-up period after last dose of study drug
356333|NCT01105975|E18|Reported Event|100 mg LY2484595 + 40 mg Simvastatin Follow-Up|30 day follow-up period after last dose of study drug
356334|NCT01105975|E17|Reported Event|40 mg Simvastatin Monotherapy Follow-Up|30 day follow-up period after last dose of study drug
356335|NCT01105975|E16|Reported Event|100 mg LY2484595 + 20 mg Atorvastatin Follow-Up|30 day follow-up period after last dose of study drug
356336|NCT01105975|E15|Reported Event|20 mg Atorvastatin Monotherapy Follow-Up|30 day follow-up period after last dose of study drug
356337|NCT01105975|E14|Reported Event|Placebo Follow-Up|30 day follow-up period after last dose of study drug
356338|NCT01105975|E13|Reported Event|500 mg LY2484595 Monotherapy Follow-Up|30 day follow-up period after last dose of study drug
356339|NCT01105975|E12|Reported Event|100 mg LY2484595 Monotherapy Follow-Up|30 day follow-up period after last dose of study drug
356340|NCT01105975|E11|Reported Event|30 mg LY2484595 Monotherapy Follow-Up|30 day follow-up period after last dose of study drug
356341|NCT01105975|E10|Reported Event|100 mg LY2484595 + 10 mg Rosuvastatin|Administered daily by mouth for 12 weeks
356342|NCT01105975|E9|Reported Event|10 mg Rosuvastatin Monotherapy|Administered daily by mouth for 12 weeks
356343|NCT01105975|E8|Reported Event|100 mg LY2484595 + 40 mg Simvastatin|Administered daily by mouth for 12 weeks
356344|NCT01105975|E7|Reported Event|40 mg Simvastatin Monotherapy|Administered daily by mouth for 12 weeks
356345|NCT01105975|E6|Reported Event|100 mg LY2484595 + 20 mg Atorvastatin|Administered daily by mouth for 12 weeks
356346|NCT01105975|E5|Reported Event|20 mg Atorvastatin Monotherapy|Administered daily by mouth for 12 weeks
356347|NCT01105975|E4|Reported Event|Placebo|Administered daily by mouth for 12 weeks
356348|NCT01105975|E3|Reported Event|500 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356349|NCT01105975|E2|Reported Event|100 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356350|NCT01105975|E1|Reported Event|30 mg LY2484595 Monotherapy|Administered daily by mouth for 12 weeks
356351|NCT01105936|B1|Baseline|Total Participants for Baseline Measurement|All randomized participants except one were evaluated for baseline measures. One participant had misallocated treatments that could not be determined. Therefore, this participant was excluded from all populations including safety.
356352|NCT01105936|P4|Participant Flow|Sequence 4|Participants took part in 3 study sessions. Session 1-no treatment was given. Session 2-participants took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 3-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
356353|NCT01105936|P3|Participant Flow|Sequence 3|Participants took part in 3 study sessions. Session 1-no treatment was given. Session 2-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 3-participants took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered.A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
356354|NCT01105936|P2|Participant Flow|Sequence 2|Participants took part in 3 study sessions. Session 1-participants took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 2-no treatment was given. Session 3-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
356355|NCT01105936|P1|Participant Flow|Sequence 1|Participants took part in 3 study sessions. Session 1-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 2-no treatment was given. Session 3-participant took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
356356|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
356357|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
356358|NCT01105936|O1|Outcome|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
356359|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
356360|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
356361|NCT01105936|O1|Outcome|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
356362|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
356363|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
356364|NCT01105936|O1|Outcome|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
356365|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
356366|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
356367|NCT01105936|O1|Outcome|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
356368|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
356369|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
356370|NCT01105936|O1|Outcome|Paracetamol 665 Milligram (mg)|Participants took two 665 mg Paracetamol sustained release caplets orally with 150mL of water.
356371|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
356372|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
356373|NCT01105936|O1|Outcome|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
356375|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
356376|NCT01105936|O1|Outcome|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
356377|NCT01105936|E3|Reported Event|No Treatment|No treatment was given to participants.
356378|NCT01105936|E2|Reported Event|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
356379|NCT01105936|E1|Reported Event|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
356380|NCT01105767|B4|Baseline|Total|Total of all reporting groups
356381|NCT01105767|B3|Baseline|Group 3 Chlorhexidine|Trainees received the components of the Standard and Enhanced Standard groups and were offered chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) to use with a wash cloth after using their personal soap for the additional once-weekly shower. Trainees were provided with verbal and written/graphic instructions for use.
356382|NCT01105767|B2|Baseline|Group 2 Enhanced Standard|Trainees received the components of the Standard group and were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit. Supplemental SSTI education for trainees and drill sergeants was also provided (e.g., pocket cards, posters). Drill sergeants received briefings on SSTI and skin inspection/minor wound care.
356383|NCT01105767|B1|Baseline|Group 1 Standard|Trainees received a preventive medicine briefing augmented with SSTI and MRSA SSTI prevention information and personal hygiene instructions. Trainees seeking medical care for an SSTI received standardized SSTI care (e.g., antimicrobial therapy, wound management, patient education) at the Troop Medical Clinic. High-touch common surfaces within the battalion areas were cleaned with standard Environmental Protection Agency registered disinfectants.
356384|NCT01105767|P3|Participant Flow|Group 3 Chlorhexidine|Trainees received the components of the Standard and Enhanced Standard groups and were offered chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) to use with a wash cloth after using their personal soap for the additional once-weekly shower. Trainees were provided with verbal and written/graphic instructions for use.
356385|NCT01105767|P2|Participant Flow|Group 2 Enhanced Standard|Trainees received the components of the Standard group and were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit. Supplemental SSTI education for trainees and drill sergeants was also provided (e.g., pocket cards, posters). Drill sergeants received briefings on SSTI and skin inspection/minor wound care.
356386|NCT01105767|P1|Participant Flow|Group 1 Standard|Trainees received a preventive medicine briefing augmented with SSTI and MRSA SSTI prevention information and personal hygiene instructions. Trainees seeking medical care for an SSTI received standardized SSTI care (e.g., antimicrobial therapy, wound management, patient education) at the Troop Medical Clinic. High-touch common surfaces within the battalion areas were cleaned with standard standard Environmental Protection Agency registered disinfectants.
356387|NCT01105767|O3|Outcome|Group 3 Chlorhexidine|Trainees received the components of the Standard and Enhanced Standard groups and were offered chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) to use with a wash cloth after using their personal soap for the additional once-weekly shower. Trainees were provided with verbal and written/graphic instructions for use.
356388|NCT01105767|O2|Outcome|Group 2 Enhanced Standard|Trainees received the components of the Standard group and were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit. Supplemental SSTI education for trainees and drill sergeants was also provided (e.g., pocket cards, posters). Drill sergeants received briefings on SSTI and skin inspection/minor wound care.
356389|NCT01105767|O1|Outcome|Group 1 Standard|Trainees received a preventive medicine briefing augmented with SSTI and MRSA SSTI prevention information and personal hygiene instructions. Trainees seeking medical care for an SSTI received standardized SSTI care (e.g., antimicrobial therapy, wound management, patient education) at the Troop Medical Clinic (TMC). High-touch common surfaces within the battalion areas were cleaned with standard Environmental Protection Agency-registered disinfectants.
356390|NCT01105767|O3|Outcome|Group 3 Chlorhexidine|Trainees received the components of the Standard and Enhanced Standard groups and were offered chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) to use with a wash cloth after using their personal soap for the additional once-weekly shower. Trainees were provided with verbal and written/graphic instructions for use.
356391|NCT01105767|O2|Outcome|Group 2 Enhanced Standard|Trainees received the components of the Standard group and were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit. Supplemental SSTI education for trainees and drill sergeants was also provided (e.g., pocket cards, posters). Drill sergeants received briefings on SSTI and skin inspection/minor wound care.
356392|NCT01105767|O1|Outcome|Group 1 Standard|Trainees received a preventive medicine briefing augmented with SSTI and MRSA SSTI prevention information and personal hygiene instructions. Trainees seeking medical care for an SSTI received standardized SSTI care (e.g., antimicrobial therapy, wound management, patient education) at the Troop Medical Clinic (TMC). High-touch common surfaces within the battalion areas were cleaned with standard Environmental Protection Agency-registered disinfectants.
356393|NCT01105767|E3|Reported Event|Group 3 Chlorhexidine|Trainees received the components of the Standard and Enhanced Standard groups and were offered chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) to use with a wash cloth after using their personal soap for the additional once-weekly shower. Trainees were provided with verbal and written/graphic instructions for use.
356394|NCT01105767|E2|Reported Event|Group 2 Enhanced Standard|Trainees received the components of the Standard group and were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit. Supplemental SSTI education for trainees and drill sergeants was also provided (e.g., pocket cards, posters). Drill sergeants received briefings on SSTI and skin inspection/minor wound care.
356456|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
356457|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
356395|NCT01105767|E1|Reported Event|Group 1 Standard|Trainees received a preventive medicine briefing augmented with SSTI and MRSA SSTI prevention information and personal hygiene instructions. Trainees seeking medical care for an SSTI received standardized SSTI care (e.g., antimicrobial therapy, wound management, patient education) at the Troop Medical Clinic. High-touch common surfaces within the battalion areas were cleaned with standard Environmental Protection Agency-registered disinfectants.
356396|NCT01105754|B3|Baseline|Total|Total of all reporting groups
356397|NCT01105754|B2|Baseline|Intervention|"Multifaceted Prompting Intervention~Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.~Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form."
356398|NCT01105754|B1|Baseline|Standard Care|Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
356399|NCT01105754|P2|Participant Flow|Intervention|"Multifaceted Prompting Intervention~Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.~Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form."
356400|NCT01105754|P1|Participant Flow|Standard Care|Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
356401|NCT01105754|O2|Outcome|Intervention|"Multifaceted Prompting Intervention~Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.~Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form."
356402|NCT01105754|O1|Outcome|Standard Care|Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
356403|NCT01105754|O2|Outcome|Intervention|"Multifaceted Prompting Intervention~Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.~Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form."
356404|NCT01105754|O1|Outcome|Standard Care|Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
356405|NCT01105754|E2|Reported Event|Intervention|"Multifaceted Prompting Intervention~Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.~Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form."
356406|NCT01105754|E1|Reported Event|Standard Care|Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
356407|NCT01105702|B1|Baseline|TBL/RT|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
356408|NCT01105702|P1|Participant Flow|TBL/RT|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
356409|NCT01105702|O2|Outcome|Grade 4|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
356410|NCT01105702|O1|Outcome|Grade 3|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
356411|NCT01105702|O1|Outcome|TBL/RT|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
356412|NCT01105702|O1|Outcome|TBL/RT|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
356413|NCT01105702|E1|Reported Event|TBL/RT|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
356414|NCT01105650|B4|Baseline|Total|Total of all reporting groups
356415|NCT01105650|B3|Baseline|Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9"
356416|NCT01105650|B2|Baseline|Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9."
356417|NCT01105650|B1|Baseline|Arm 1: CsA|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses)."
356418|NCT01105650|P4|Participant Flow|Arm 4: CsA/no Methylprednisolone/3 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin-2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 3 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 3 million units/m^2 3 times per week for 3 doses)."
356419|NCT01105650|P3|Participant Flow|Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9"
356420|NCT01105650|P2|Participant Flow|Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9."
356458|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
356459|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
356460|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
356818|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
356421|NCT01105650|P1|Participant Flow|Arm 1: CsA|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses)."
356422|NCT01105650|O3|Outcome|Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9"
356423|NCT01105650|O2|Outcome|Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9."
356424|NCT01105650|O1|Outcome|Arm 1: CsA|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses)."
356425|NCT01105650|O3|Outcome|Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9"
356426|NCT01105650|O2|Outcome|Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9."
356427|NCT01105650|O1|Outcome|Arm 1: CsA|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses)."
356428|NCT01105650|O3|Outcome|Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9"
356429|NCT01105650|O2|Outcome|Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9."
356430|NCT01105650|O1|Outcome|Arm 1: CsA|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses)."
356431|NCT01105650|O3|Outcome|Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9"
356432|NCT01105650|O2|Outcome|Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9."
356433|NCT01105650|O1|Outcome|Arm 1: CsA|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses)."
356434|NCT01105650|E3|Reported Event|Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9"
356435|NCT01105650|E2|Reported Event|Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9."
356436|NCT01105650|E1|Reported Event|Arm 1: CsA|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses)."
356437|NCT01105533|B1|Baseline|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
356438|NCT01105533|P9|Participant Flow|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
356439|NCT01105533|P8|Participant Flow|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
356440|NCT01105533|P7|Participant Flow|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
356441|NCT01105533|P6|Participant Flow|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
356442|NCT01105533|P5|Participant Flow|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
356443|NCT01105533|P4|Participant Flow|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
356444|NCT01105533|P3|Participant Flow|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
356445|NCT01105533|P2|Participant Flow|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
356446|NCT01105533|P1|Participant Flow|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
356447|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
356448|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
356449|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
356450|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
356451|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
356452|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
356453|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
356454|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
356455|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
356819|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
356461|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
356462|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
356463|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
356464|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
356465|NCT01105533|O1|Outcome|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
356466|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
356467|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
356468|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
356469|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
356470|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
356471|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
356472|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
356473|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
356474|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
356475|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
356476|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
356477|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
356478|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
356479|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
356480|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
356481|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
356482|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
356483|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
356484|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
356485|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
356486|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
356487|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
356488|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
356489|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
356490|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
356491|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
356492|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
356493|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
356494|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
356495|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
356496|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
356497|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
356498|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
356499|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
356500|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
356501|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
356502|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
356503|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
356504|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
356505|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
356506|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
356507|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
356508|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
356509|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
356510|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
356511|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
356512|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
356513|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
356514|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
356515|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
356516|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
356517|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
356518|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
356519|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
356520|NCT01105533|O1|Outcome|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
356521|NCT01105533|O1|Outcome|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
356522|NCT01105533|O1|Outcome|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
356523|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
356524|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
356525|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
356526|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
356527|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
356528|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
356529|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
356530|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
356531|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
356532|NCT01105533|E1|Reported Event|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
356533|NCT01105377|B3|Baseline|Total|Total of all reporting groups
356534|NCT01105377|B2|Baseline|Cohort II|Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
356535|NCT01105377|B1|Baseline|Cohort I|Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.
356536|NCT01105377|P2|Participant Flow|Cohort II|Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
356537|NCT01105377|P1|Participant Flow|Cohort I|Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.
356538|NCT01105377|O2|Outcome|Cohort II|Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
356539|NCT01105377|O1|Outcome|Cohort I|Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.
356540|NCT01105377|O2|Outcome|Cohort II|Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
356541|NCT01105377|O1|Outcome|Cohort I|Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.
356542|NCT01105377|E2|Reported Event|Cohort II|Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
356820|NCT01104584|O1|Outcome|CMRM vs UMRM|
356543|NCT01105377|E1|Reported Event|Cohort I|Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.
356544|NCT01105312|B4|Baseline|Total|Total of all reporting groups
356545|NCT01105312|B3|Baseline|Phase I: Dose Level Two|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 30 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
356546|NCT01105312|B2|Baseline|Phase I: Dose Level One|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
356547|NCT01105312|B1|Baseline|Phase II|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
356548|NCT01105312|P3|Participant Flow|Phase I: Dose Level Two|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 30 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
356549|NCT01105312|P2|Participant Flow|Phase I: Dose Level One|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
356550|NCT01105312|P1|Participant Flow|Phase II|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
356551|NCT01105312|O2|Outcome|Phase I: Dose Level Two|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 30 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
356552|NCT01105312|O1|Outcome|Phase I: Dose Level One|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
356553|NCT01105312|O1|Outcome|Phase II|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
356554|NCT01105312|O1|Outcome|Phase II|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
356555|NCT01105312|O1|Outcome|Phase II|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
356556|NCT01105312|O1|Outcome|Phase II|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
356557|NCT01105312|O1|Outcome|Phase II|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
356558|NCT01105312|O1|Outcome|Phase II|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
356559|NCT01105312|O1|Outcome|Phase II|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
356560|NCT01105312|O2|Outcome|Phase I: Dose Level Two|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 30 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
356561|NCT01105312|O1|Outcome|Phase I: Dose Level One|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
356562|NCT01105312|E3|Reported Event|Phase I: Dose Level Two|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 30 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
356563|NCT01105312|E2|Reported Event|Phase I: Dose Level One|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
356564|NCT01105312|E1|Reported Event|Phase II|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
356565|NCT01105247|B3|Baseline|Total|Total of all reporting groups
356566|NCT01105247|B2|Baseline|Food Effect Cohort|PCI-32765: 420 mg daily
356567|NCT01105247|B1|Baseline|PCI-32765|PCI-32765: 420 mg daily or 840 mg daily
356568|NCT01105247|P2|Participant Flow|Food Effect Cohort|PCI-32765: 420 mg daily
356569|NCT01105247|P1|Participant Flow|PCI-32765|PCI-32765: 420 mg daily or 840 mg daily.
356570|NCT01105247|O3|Outcome|Food Effect|Food-Effect Relapsed/refractory participants received PCI-32765 420 mg daily
356571|NCT01105247|O2|Outcome|Relapsed/ Refractory|PCI-32765: 420 mg daily or 840 mg daily
356572|NCT01105247|O1|Outcome|Treatment Naive|PCI-32765: 420 mg daily or 840 mg daily
356573|NCT01105247|O3|Outcome|Food- Effect|Food-Effect Relapsed/refractory participants received PCI-32765 420 mg daily
356574|NCT01105247|O2|Outcome|Relapsed/ Refractory|PCI-32765: 420 mg daily or 840 mg daily
356575|NCT01105247|O1|Outcome|Treatment Naive|PCI-32765: 420 mg daily or 840 mg daily
356576|NCT01105247|O1|Outcome|Food Effect Cohort|PCI-32765: 420 mg daily
356577|NCT01105247|O2|Outcome|Food Effect|Food-Effect Relapsed/Refractory participants received PCI-32765 420 mg daily
356578|NCT01105247|O1|Outcome|PCI-32765|PCI-32765: 420 mg daily or 840 mg daily
356579|NCT01105247|E2|Reported Event|Food Effect|PCI-32765: 420 mg daily
356580|NCT01105247|E1|Reported Event|PCI-32765|PCI-32765: 420 mg daily or 840 mg daily
356581|NCT01105130|B4|Baseline|Total|Total of all reporting groups
356582|NCT01105130|B3|Baseline|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules~Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
356583|NCT01105130|B2|Baseline|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).~Placebo: Given orally~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
356584|NCT01105130|B1|Baseline|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).~Placebo: Given orally"
356585|NCT01105130|P3|Participant Flow|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules~Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
356586|NCT01105130|P2|Participant Flow|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).~Placebo: Given orally~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
356587|NCT01105130|P1|Participant Flow|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).~Placebo: Given orally"
356588|NCT01105130|O3|Outcome|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules~Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
356589|NCT01105130|O2|Outcome|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).~Placebo: Given orally~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
356590|NCT01105130|O1|Outcome|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).~Placebo: Given orally"
356591|NCT01105130|O3|Outcome|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules~Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
356592|NCT01105130|O2|Outcome|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).~Placebo: Given orally~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
356593|NCT01105130|O1|Outcome|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).~Placebo: Given orally"
356594|NCT01105130|O3|Outcome|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules~Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
356595|NCT01105130|O2|Outcome|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).~Placebo: Given orally~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
356596|NCT01105130|O1|Outcome|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).~Placebo: Given orally"
356597|NCT01105130|O3|Outcome|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules~Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
356598|NCT01105130|O2|Outcome|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).~Placebo: Given orally~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
356599|NCT01105130|O1|Outcome|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).~Placebo: Given orally"
356600|NCT01105130|E3|Reported Event|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules~Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
356601|NCT01105130|E2|Reported Event|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).~Placebo: Given orally~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
356602|NCT01105130|E1|Reported Event|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).~Placebo: Given orally"
356603|NCT01105117|B3|Baseline|Total|Total of all reporting groups
356604|NCT01105117|B2|Baseline|Flolan® (Epoprostenol Sodium) for Injection|"Flolan®~Flolan® : per Prescribing Information"
356605|NCT01105117|B1|Baseline|ACT-385781A (Epoprostenol for Injection)|"ACT-385781A (Actelion Epoprostenol)~ACT-385781A (Actelion Epoprostenol) : per Prescribing Information"
356606|NCT01105117|P2|Participant Flow|Flolan® (Epoprostenol Sodium) for Injection|"Flolan®~Flolan® : per Prescribing Information"
356607|NCT01105117|P1|Participant Flow|ACT-385781A (Epoprostenol for Injection)|"ACT-385781A (Actelion Epoprostenol)~ACT-385781A (Actelion Epoprostenol) : per Prescribing Information"
356608|NCT01105117|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|"Flolan®~Flolan® : per Prescribing Information"
356609|NCT01105117|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|"ACT-385781A (Actelion Epoprostenol)~ACT-385781A (Actelion Epoprostenol) : per Prescribing Information"
356610|NCT01105117|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|"Flolan®~Flolan® : per Prescribing Information"
356611|NCT01105117|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|"ACT-385781A (Actelion Epoprostenol)~ACT-385781A (Actelion Epoprostenol) : per Prescribing Information"
356612|NCT01105117|E2|Reported Event|Flolan® (Epoprostenol Sodium) for Injection|"Flolan®~Flolan® : per Prescribing Information"
356613|NCT01105117|E1|Reported Event|ACT-385781A (Epoprostenol for Injection)|"ACT-385781A (Actelion Epoprostenol)~ACT-385781A (Actelion Epoprostenol) : per Prescribing Information"
356614|NCT01105091|B3|Baseline|Total|Total of all reporting groups
356615|NCT01105091|B2|Baseline|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
356821|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
356616|NCT01105091|B1|Baseline|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
356617|NCT01105091|P2|Participant Flow|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
356618|NCT01105091|P1|Participant Flow|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
356619|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
356620|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
356621|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
356622|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
356623|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
356624|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
356625|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
356626|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
356627|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
356628|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
356629|NCT01105091|O2|Outcome|Flolan (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
356630|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
356631|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
356632|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
356633|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
356634|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
356635|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
356636|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
356822|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
356823|NCT01104584|O1|Outcome|CMRM vs UMRM|
356637|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
356638|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
356639|NCT01105091|E2|Reported Event|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
356640|NCT01105091|E1|Reported Event|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
356641|NCT01105065|B1|Baseline|Patients With RVD|"Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks.~Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks."
356642|NCT01105065|P1|Participant Flow|Patients With RVD|"Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks.~Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks."
356643|NCT01105065|O2|Outcome|RVD Patients Post-brimonidine Treatment|Patients who exhibited retinal vascular dysregulation at the initial visit. The mean deviation frequency doubling perimetry values were measured in these patients after their treatment with brimonidine.
356644|NCT01105065|O1|Outcome|RVD Patients Pre-brimonidine Treatment|Patients who exhibited retinal vascular dysregulation at the initial visit. The mean deviation frequency doubling perimetry values were measured in these patients before their treatment with brimonidine.
356645|NCT01105065|O1|Outcome|Patients With RVD|"Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks.~Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks."
356646|NCT01105065|E1|Reported Event|Patients With RVD|"Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks.~Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks."
356647|NCT01104870|B4|Baseline|Total|Total of all reporting groups
356648|NCT01104870|B3|Baseline|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
356649|NCT01104870|B2|Baseline|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
356650|NCT01104870|B1|Baseline|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
356651|NCT01104870|P3|Participant Flow|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
356652|NCT01104870|P2|Participant Flow|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
356653|NCT01104870|P1|Participant Flow|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
356654|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
356655|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
356656|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
356657|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
356658|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
356659|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
356660|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
356661|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
356662|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
356663|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
356664|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
356665|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
356666|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
356667|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
356668|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
356669|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
356670|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
356671|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
356672|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
356673|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
356674|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
356675|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
356676|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
356677|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
356678|NCT01104870|E3|Reported Event|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
356679|NCT01104870|E2|Reported Event|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
356680|NCT01104870|E1|Reported Event|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
356681|NCT01104701|B5|Baseline|Total|Total of all reporting groups
356682|NCT01104701|B4|Baseline|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides.
356683|NCT01104701|B3|Baseline|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides. .
356684|NCT01104701|B2|Baseline|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides.
356685|NCT01104701|B1|Baseline|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC).
356686|NCT01104701|P4|Participant Flow|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356687|NCT01104701|P3|Participant Flow|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356688|NCT01104701|P2|Participant Flow|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356689|NCT01104701|P1|Participant Flow|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
356690|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356691|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
356692|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356693|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
356694|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356695|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
356696|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356697|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
356698|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356699|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
356700|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356701|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
356702|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356703|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
356704|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356705|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
356706|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356707|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
356708|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356709|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
356710|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356711|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
356712|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356713|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
356714|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356715|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
356716|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356717|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
356718|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356824|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
356825|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
356719|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
356720|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356721|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
356722|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356723|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
356724|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356725|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
356726|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356727|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
356728|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356729|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
356730|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356731|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
356732|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356733|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
356734|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356735|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
356736|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
356737|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
356738|NCT01104701|E4|Reported Event|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides.
356739|NCT01104701|E3|Reported Event|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides. .
356740|NCT01104701|E2|Reported Event|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides.
356741|NCT01104701|E1|Reported Event|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC).
356742|NCT01104662|B9|Baseline|Total|Total of all reporting groups
356743|NCT01104662|B8|Baseline|Vancomycin or SSP, cSSSI, Moderate Renal Impairment|Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
356744|NCT01104662|B7|Baseline|Daptomycin, cSSSI, Moderate Renal Impairment|Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
356745|NCT01104662|B6|Baseline|Vancomycin or SSP, cSSSI, Severe Renal Impairment|Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
356826|NCT01104584|O1|Outcome|CMRM vs UMRM|
356827|NCT01104584|O5|Outcome|CMRM+XRM|
356828|NCT01104584|O4|Outcome|UMRM+XRM|
356829|NCT01104584|O3|Outcome|X-ray Mammography (XRM)|
356830|NCT01104584|O2|Outcome|CMRM|
356746|NCT01104662|B5|Baseline|Daptomycin, cSSSI, Severe Renal Impairment|Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
356747|NCT01104662|B4|Baseline|Vancomycin or SSP, Bacteremia, Moderate Renal Impairment|Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
356748|NCT01104662|B3|Baseline|Daptomycin, Bacteremia, Moderate Renal Impairment|Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
356749|NCT01104662|B2|Baseline|Vancomycin or SSP, Bacteremia, Severe Renal Impairment|Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
356750|NCT01104662|B1|Baseline|Daptomycin, Bacteremia, Severe Renal Impairment|Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
356751|NCT01104662|P8|Participant Flow|Vancomycin or SSP, cSSSI, Moderate Renal Impairment|Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
356752|NCT01104662|P7|Participant Flow|Daptomycin, cSSSI, Moderate Renal Impairment|Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
356753|NCT01104662|P6|Participant Flow|Vancomycin or SSP, cSSSI, Severe Renal Impairment|Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
356754|NCT01104662|P5|Participant Flow|Daptomycin, cSSSI, Severe Renal Impairment|Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For complicated skin and skin structure infections (cSSSI) participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
356755|NCT01104662|P4|Participant Flow|Vancomycin or SSP, Bacteremia, Moderate Renal Impairment|Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per investigator’s discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
356756|NCT01104662|P3|Participant Flow|Daptomycin, Bacteremia, Moderate Renal Impairment|Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
356831|NCT01104584|O1|Outcome|UMRM|
356832|NCT01104584|O4|Outcome|UMRM+XRM|
356833|NCT01104584|O3|Outcome|CMRM+XRM|
356834|NCT01104584|O2|Outcome|X-ray Mammography (XRM)|
356757|NCT01104662|P2|Participant Flow|Vancomycin or SSP, Bacteremia, Severe Renal Impairment|Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin/semi-synthetic penicillin (SSP; for example, nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per investigator’s discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
356758|NCT01104662|P1|Participant Flow|Daptomycin, Bacteremia, Severe Renal Impairment|Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
356759|NCT01104662|O8|Outcome|Vancomycin or SSP, cSSSI, Moderate Renal Impairment|Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
356760|NCT01104662|O7|Outcome|Daptomycin, cSSSI, Moderate Renal Impairment|Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
356761|NCT01104662|O6|Outcome|Vancomycin or SSP, cSSSI, Severe Renal Impairment|Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
356762|NCT01104662|O5|Outcome|Daptomycin, cSSSI, Severe Renal Impairment|Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
356763|NCT01104662|O4|Outcome|Vancomycin or SSP, Bacteremia, Moderate Renal Impairment|Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
356764|NCT01104662|O3|Outcome|Daptomycin, Bacteremia, Moderate Renal Impairment|Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion
356765|NCT01104662|O2|Outcome|Vancomycin or SSP, Bacteremia, Severe Renal Impairment|Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
356766|NCT01104662|O1|Outcome|Daptomycin, Bacteremia, Severe Renal Impairment|Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
356778|NCT01104662|E5|Reported Event|Daptomycin, cSSSI, Severe Renal Impairment|Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
356835|NCT01104584|O1|Outcome|UMRM|
356767|NCT01104662|O8|Outcome|Vancomycin or SSP, cSSSI, Moderate Renal Impairment|Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
356768|NCT01104662|O7|Outcome|Daptomycin, cSSSI, Moderate Renal Impairment|Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
356769|NCT01104662|O6|Outcome|Vancomycin or SSP, cSSSI, Severe Renal Impairment|Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
356770|NCT01104662|O5|Outcome|Daptomycin, cSSSI, Severe Renal Impairment|Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
356771|NCT01104662|O4|Outcome|Vancomycin or SSP, Bacteremia, Moderate Renal Impairment|Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
356772|NCT01104662|O3|Outcome|Daptomycin, Bacteremia, Moderate Renal Impairment|Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
356773|NCT01104662|O2|Outcome|Vancomycin or SSP, Bacteremia, Severe Renal Impairment|Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
356774|NCT01104662|O1|Outcome|Daptomycin, Bacteremia, Severe Renal Impairment|Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
356775|NCT01104662|E8|Reported Event|Vancomycin or SSP, cSSSI, Moderate Renal Impairment|Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
356776|NCT01104662|E7|Reported Event|Daptomycin, cSSSI, Moderate Renal Impairment|Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
356777|NCT01104662|E6|Reported Event|Vancomycin or SSP, cSSSI, Severe Renal Impairment|Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
356803|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
356836|NCT01104584|O4|Outcome|UMRM+XRM|
356779|NCT01104662|E4|Reported Event|Vancomycin or SSP, Bacteremia, Moderate Renal Impairment|Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
356780|NCT01104662|E3|Reported Event|Daptomycin, Bacteremia, Moderate Renal Impairment|Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
356781|NCT01104662|E2|Reported Event|Vancomycin or SSP, Bacteremia, Severe Renal Impairment|Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
356782|NCT01104662|E1|Reported Event|Daptomycin, Bacteremia, Severe Renal Impairment|Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.)
356783|NCT01104636|B1|Baseline|Varenicline|Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
356784|NCT01104636|P1|Participant Flow|Varenicline|Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
356785|NCT01104636|O1|Outcome|Varenicline|Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
356786|NCT01104636|O1|Outcome|Varenicline|Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
356787|NCT01104636|E1|Reported Event|Varenicline|Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
356788|NCT01104584|B1|Baseline|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced MRM, followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg bw [0.1 ml/kg bw] as an i.v. injection at a rate of 2 ml/sec. UMRM and CMRM image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective XRM was added and evaluated together with the UMRM images.
356789|NCT01104584|P1|Participant Flow|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection (i.v.) at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
356790|NCT01104584|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Patients first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
356791|NCT01104584|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Patients first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
356792|NCT01104584|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Patients first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
356793|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
356794|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
356795|NCT01104584|O1|Outcome|CMRM Versus UMRM|
356796|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
356797|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
356798|NCT01104584|O1|Outcome|CMRM Versus UMRM|
356799|NCT01104584|O1|Outcome|CMRM|
356800|NCT01104584|O1|Outcome|CMRM|
356801|NCT01104584|O1|Outcome|CMRM|
356802|NCT01104584|O1|Outcome|CMRM Versus UMRM|
356838|NCT01104584|O2|Outcome|X-ray Mammography (XRM)|
356839|NCT01104584|O1|Outcome|UMRM|
356840|NCT01104584|O3|Outcome|UMRM+XRM|
356841|NCT01104584|O2|Outcome|CMRM+XRM|
356842|NCT01104584|O1|Outcome|X-ray Mammography (XRM)|
356843|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
356844|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
356845|NCT01104584|O1|Outcome|CMRM Versus UMRM|
356846|NCT01104584|O3|Outcome|CMRM vs CMRM+XRM|
356847|NCT01104584|O2|Outcome|CMRM vs XRM|
356848|NCT01104584|O1|Outcome|CMRM Versus UMRM|
356849|NCT01104584|O3|Outcome|CMRM vs CMRM+XRM|
356850|NCT01104584|O2|Outcome|CMRM vs XRM|
356851|NCT01104584|O1|Outcome|CMRM Versus UMRM|
356852|NCT01104584|O1|Outcome|CMRM|
356853|NCT01104584|O1|Outcome|CMRM|
356854|NCT01104584|O2|Outcome|UMRM|
356855|NCT01104584|O1|Outcome|CMRM|
356856|NCT01104584|O1|Outcome|CMRM Versus UMRM|
356857|NCT01104584|E1|Reported Event|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection at a rate of 2 ml/sec. unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
356858|NCT01104558|B1|Baseline|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356859|NCT01104558|P1|Participant Flow|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356860|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356861|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356862|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356863|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356864|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356865|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356866|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356867|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356868|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356869|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356870|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356871|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356872|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356873|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356874|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356875|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356876|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356877|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356878|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356879|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356880|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356881|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356882|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356883|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356884|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356885|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356886|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356887|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356888|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356889|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356954|NCT01104402|O1|Outcome|Standard Care|Subjects will receive education about signs and symptoms indicative of worsening CF.
357176|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
356890|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356891|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356892|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356893|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356894|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356895|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356896|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356897|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356898|NCT01104558|E1|Reported Event|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
356899|NCT01104493|B3|Baseline|Total|Total of all reporting groups
356900|NCT01104493|B2|Baseline|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
356901|NCT01104493|B1|Baseline|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
356902|NCT01104493|P2|Participant Flow|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
356903|NCT01104493|P1|Participant Flow|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
356904|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
356905|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
356906|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
356907|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
356908|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
356909|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
356910|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
360692|NCT01092442|O2|Outcome|Prospective Ross|
356911|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
356912|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
356913|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
356914|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
356915|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
356916|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
356917|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
356918|NCT01104493|E2|Reported Event|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
356919|NCT01104493|E1|Reported Event|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
356920|NCT01104415|B1|Baseline|LX1606 - Core Phase|
356921|NCT01104415|P1|Participant Flow|LX1606 - Core Phase|
356922|NCT01104415|O1|Outcome|LX1606 - Extension Period|
356923|NCT01104415|O1|Outcome|LX1606 - Extension Period|
356924|NCT01104415|O1|Outcome|LX1606 - Extension Period|
356925|NCT01104415|O1|Outcome|LX1606 - Extension Period|
356926|NCT01104415|O1|Outcome|LX1606 - Extension Period|
356927|NCT01104415|O1|Outcome|LX1606 - Extension Period|
356928|NCT01104415|O1|Outcome|LX1606 - Extension Period|
356929|NCT01104415|O1|Outcome|LX1606 - Extension Period|
356930|NCT01104415|O1|Outcome|LX1606 - Core Phase|
356931|NCT01104415|O1|Outcome|LX1606 - Core Phase|
356932|NCT01104415|O1|Outcome|LX1606 - Core Phase|
356933|NCT01104415|O1|Outcome|LX1606 - Core Phase|
356934|NCT01104415|O1|Outcome|LX1606 - Core Phase|
356935|NCT01104415|O1|Outcome|LX1606 - Core Phase|
356936|NCT01104415|O1|Outcome|LX1606 - Core Phase|
356937|NCT01104415|O1|Outcome|LX1606 - Core Phase|
356938|NCT01104415|O1|Outcome|LX1606 - Extension Period|
356939|NCT01104415|O1|Outcome|LX1606 - Core Phase|
356940|NCT01104415|E2|Reported Event|LX1606 - Extension Period|
356941|NCT01104415|E1|Reported Event|LX1606 - Core Phase|
356942|NCT01104402|B3|Baseline|Total|Total of all reporting groups
356943|NCT01104402|B2|Baseline|Home Monitoring|"Subjects will be randomized to monitor home spirometry and symptoms using a handheld device.~Home lung function and symptom monitoring: subjects in the intervention arm will measure spirometry and CF symptoms with the use of a handheld device."
356944|NCT01104402|B1|Baseline|Standard Care|Subjects will receive education about signs and symptoms indicative of worsening CF.
356945|NCT01104402|P2|Participant Flow|Home Monitoring|"Subjects will be randomized to monitor home spirometry and symptoms using a handheld device.~Home lung function and symptom monitoring: subjects in the intervention arm will measure spirometry and CF symptoms with the use of a handheld device."
356946|NCT01104402|P1|Participant Flow|Standard Care|Subjects will receive education about signs and symptoms indicative of worsening CF.
356947|NCT01104402|O2|Outcome|Home Monitoring|"Subjects will be randomized to monitor home spirometry and symptoms using a handheld device.~Home lung function and symptom monitoring: subjects in the intervention arm will measure spirometry and CF symptoms with the use of a handheld device."
356948|NCT01104402|O1|Outcome|Standard Care|Subjects will receive education about signs and symptoms indicative of worsening CF.
356949|NCT01104402|O2|Outcome|Home Monitoring|"Subjects will be randomized to monitor home spirometry and symptoms using a handheld device.~Home lung function and symptom monitoring: subjects in the intervention arm will measure spirometry and CF symptoms with the use of a handheld device."
356950|NCT01104402|O1|Outcome|Standard Care|Subjects will receive education about signs and symptoms indicative of worsening CF.
356951|NCT01104402|O2|Outcome|Home Monitoring|"Subjects will be randomized to monitor home spirometry and symptoms using a handheld device.~Home lung function and symptom monitoring: subjects in the intervention arm will measure spirometry and CF symptoms with the use of a handheld device."
356952|NCT01104402|O1|Outcome|Standard Care|Subjects will receive education about signs and symptoms indicative of worsening CF.
356953|NCT01104402|O2|Outcome|Home Monitoring|"Subjects will be randomized to monitor home spirometry and symptoms using a handheld device.~Home lung function and symptom monitoring: subjects in the intervention arm will measure spirometry and CF symptoms with the use of a handheld device."
356955|NCT01104402|O2|Outcome|Home Monitoring|"Subjects will be randomized to monitor home spirometry and symptoms using a handheld device.~Home lung function and symptom monitoring: subjects in the intervention arm will measure spirometry and CF symptoms with the use of a handheld device."
356956|NCT01104402|O1|Outcome|Standard Care|Subjects will receive education about signs and symptoms indicative of worsening CF.
356957|NCT01104402|O2|Outcome|Home Monitoring|"Subjects will be randomized to monitor home spirometry and symptoms using a handheld device.~Home lung function and symptom monitoring: subjects in the intervention arm will measure spirometry and CF symptoms with the use of a handheld device."
356958|NCT01104402|O1|Outcome|Standard Care|Subjects will receive education about signs and symptoms indicative of worsening CF.
356959|NCT01104402|O2|Outcome|Home Monitoring|"Subjects will be randomized to monitor home spirometry and symptoms using a handheld device.~Home lung function and symptom monitoring: subjects in the intervention arm will measure spirometry and CF symptoms with the use of a handheld device."
356960|NCT01104402|O1|Outcome|Standard Care|Subjects will receive education about signs and symptoms indicative of worsening CF.
356961|NCT01104402|E2|Reported Event|Home Monitoring|"Subjects will be randomized to monitor home spirometry and symptoms using a handheld device.~Home lung function and symptom monitoring: subjects in the intervention arm will measure spirometry and CF symptoms with the use of a handheld device."
356962|NCT01104402|E1|Reported Event|Standard Care|Subjects will receive education about signs and symptoms indicative of worsening CF.
356963|NCT01104376|B1|Baseline|CYP2B6|"Healthy volunteers will receive Efavirenz and Vericonazole as follow:~In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered. In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily."
356964|NCT01104376|P1|Participant Flow|CYP2B6 Activity|"CYP2B6 activity was measured using efavirenz metabolism and pharmacokinetics at baseline and after pretreatment with voriconazole.~In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered.~In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily."
356965|NCT01104376|O1|Outcome|CYP2B6|"Healthy volunteers will receive Efavirenz and Vericonazole as follow:~In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered. In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily."
356966|NCT01104376|E1|Reported Event|CYP2B6|"Healthy volunteers will receive Efavirenz and Vericonazole as follow:~In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered. In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily."
356967|NCT01104311|B3|Baseline|Total|Total of all reporting groups
356968|NCT01104311|B2|Baseline|Modest BP Lowering|Lowering of systolic blood pressure between 130mmHg and 140mmHg modest blood pressure lowering: adjust the amount and number of antihypertensive drugs
356969|NCT01104311|B1|Baseline|Aggressive BP Lowering|Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
356970|NCT01104311|P2|Participant Flow|Modest BP Lowering|"Lowering of systolic blood pressure between 130mmHg and 140mmHg~modest blood pressure lowering: adjust the amount and number of antihypertensive drugs"
356971|NCT01104311|P1|Participant Flow|Aggressive BP Lowering|"Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period~Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level"
356972|NCT01104311|O2|Outcome|Modest BP Lowering|"Lowering of systolic blood pressure between 130mmHg and 140mmHg~modest blood pressure lowering: adjust the amount and number of antihypertensive drugs (Safety population: 65)"
356973|NCT01104311|O1|Outcome|Aggressive BP Lowering|"Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period~Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level (Safety population: 65)"
356974|NCT01104311|O2|Outcome|Modest BP Lowering|"Lowering of systolic blood pressure between 130mmHg and 140mmHg~modest blood pressure lowering: adjust the amount and number of antihypertensive drugs"
356975|NCT01104311|O1|Outcome|Aggressive BP Lowering|"Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period~Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level"
356976|NCT01104311|O2|Outcome|Modest BP Lowering|"Lowering of systolic blood pressure between 130mmHg and 140mmHg~modest blood pressure lowering: adjust the amount and number of antihypertensive drugs"
356977|NCT01104311|O1|Outcome|Aggressive BP Lowering|"Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period~Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level"
356978|NCT01104311|O2|Outcome|Modest BP Lowering|"Lowering of systolic blood pressure between 130mmHg and 140mmHg~modest blood pressure lowering: adjust the amount and number of antihypertensive drugs"
356979|NCT01104311|O1|Outcome|Aggressive BP Lowering|"Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period~Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level"
356980|NCT01104311|O2|Outcome|Modest BP Lowering|Lowering of systolic blood pressure between 130mmHg and 140mmHg modest blood pressure lowering: adjust the amount and number of antihypertensive drugs
357177|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
356981|NCT01104311|O1|Outcome|Aggressive BP Lowering|Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
356982|NCT01104311|O2|Outcome|Modest BP Lowering|"Lowering of systolic blood pressure between 130mmHg and 140mmHg~modest blood pressure lowering: adjust the amount and number of antihypertensive drugs"
356983|NCT01104311|O1|Outcome|Aggressive BP Lowering|"Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period~Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level"
356984|NCT01104311|O2|Outcome|Modest BP Lowering|Lowering of systolic blood pressure between 130mmHg and 140mmHg modest blood pressure lowering: adjust the amount and number of antihypertensive drugs
356985|NCT01104311|O1|Outcome|Aggressive BP Lowering|Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
356986|NCT01104311|E2|Reported Event|Modest BP Lowering|"Lowering of systolic blood pressure between 130mmHg and 140mmHg~modest blood pressure lowering: adjust the amount and number of antihypertensive drugs (Safety population: 65)"
356987|NCT01104311|E1|Reported Event|Aggressive BP Lowering|"Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period~Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level (Safety population: 65)"
356988|NCT01104285|B3|Baseline|Total|Total of all reporting groups
356989|NCT01104285|B2|Baseline|Chest Tube|Treatment of pleural effusion with diuresis and chest tube
356990|NCT01104285|B1|Baseline|Standard Care|Treatment of pleural effusion with diuresis
356991|NCT01104285|P2|Participant Flow|Chest Tube|Treatment of pleural effusion with diuresis and chest tube
356992|NCT01104285|P1|Participant Flow|Standard Care|Treatment of pleural effusion with diuresis
356993|NCT01104285|O2|Outcome|Chest Tube|Treatment of pleural effusion with diuresis and chest tube
356994|NCT01104285|O1|Outcome|Standard Care|Treatment of pleural effusion with diuresis
356995|NCT01104285|E2|Reported Event|Chest Tube|Treatment of pleural effusion with diuresis and chest tube
356996|NCT01104285|E1|Reported Event|Standard Care|Treatment of pleural effusion with diuresis
356997|NCT01104246|B1|Baseline|Testosterone Transdermal Systems|Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
356998|NCT01104246|P1|Participant Flow|Testosterone Transdermal Systems|Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
356999|NCT01104246|O1|Outcome|Testosterone Transdermal Systems|Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
357000|NCT01104246|E1|Reported Event|Testosterone Transdermal Systems|Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
357001|NCT01104207|B3|Baseline|Total|Total of all reporting groups
357002|NCT01104207|B2|Baseline|Arm 2|"For half of the subjects, placebo rTMS will be delivered to one side of the head.~placebo rTMS: placebo rTMS"
357003|NCT01104207|B1|Baseline|Arm 1|"For half of the subjects, rTMS will be delivered to one side of the head.~repetitive transcranial magnetic stimulation (rTMS): rTMS involves application of electromagnetic pulses through a coil to the subject's scalp. Some of the electromagnetic energy is transmitted to underlying neural tissue. The goal for this study: 1 Hz rTMS will suppress neural activity responsible for tinnitus perception."
357004|NCT01104207|P2|Participant Flow|Arm 2|"For half of the subjects, placebo rTMS will be delivered to one side of the head.~placebo rTMS: placebo rTMS"
357005|NCT01104207|P1|Participant Flow|Arm 1|"For half of the subjects, rTMS will be delivered to one side of the head.~repetitive transcranial magnetic stimulation (rTMS): rTMS involves application of electromagnetic pulses through a coil to the subject's scalp. Some of the electromagnetic energy is transmitted to underlying neural tissue. The goal for this study: 1 Hz rTMS will suppress neural activity responsible for tinnitus perception."
357006|NCT01104207|O2|Outcome|Arm 2|"For half of the subjects, placebo rTMS will be delivered to one side of the head.~placebo rTMS: placebo rTMS"
357007|NCT01104207|O1|Outcome|Arm 1|"For half of the subjects, rTMS will be delivered to one side of the head.~repetitive transcranial magnetic stimulation (rTMS): rTMS involves application of electromagnetic pulses through a coil to the subject's scalp. Some of the electromagnetic energy is transmitted to underlying neural tissue. The goal for this study: 1 Hz rTMS will suppress neural activity responsible for tinnitus perception."
357008|NCT01104207|E2|Reported Event|Arm 2|"For half of the subjects, placebo rTMS will be delivered to one side of the head.~placebo rTMS: placebo rTMS"
357009|NCT01104207|E1|Reported Event|Arm 1|"For half of the subjects, rTMS will be delivered to one side of the head.~repetitive transcranial magnetic stimulation (rTMS): rTMS involves application of electromagnetic pulses through a coil to the subject's scalp. Some of the electromagnetic energy is transmitted to underlying neural tissue. The goal for this study: 1 Hz rTMS will suppress neural activity responsible for tinnitus perception."
357010|NCT01104155|B3|Baseline|Total|Total of all reporting groups
357011|NCT01104155|B2|Baseline|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
357012|NCT01104155|B1|Baseline|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
357013|NCT01104155|P2|Participant Flow|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
357046|NCT01103973|P2|Participant Flow|Mind/Body Program|"Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.~Mind/Body Program: Ten week group mind/body program"
357014|NCT01104155|P1|Participant Flow|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
357015|NCT01104155|O2|Outcome|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
357016|NCT01104155|O1|Outcome|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
357017|NCT01104155|O2|Outcome|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
357018|NCT01104155|O1|Outcome|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
357019|NCT01104155|O2|Outcome|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
357020|NCT01104155|O1|Outcome|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
357021|NCT01104155|O2|Outcome|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
357022|NCT01104155|O1|Outcome|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
357023|NCT01104155|O2|Outcome|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
357024|NCT01104155|O1|Outcome|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
357025|NCT01104155|E2|Reported Event|Eribulin Mesylate, 28 Day Cycle|eribulin mesylate + erlotinib: 28-day Regimen: Eribulin mesylate given at a dose of 1.4 mg/m2 as a 2-5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15-28 of a 28-day cycle.
357026|NCT01104155|E1|Reported Event|Eribulin Mesylate, 21 Day Cycle|eribulin mesylate + erlotinib: 21-day Regimen: Eribulin mesylate given at a dose of 2 mg/m2 as a 2-5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 2-16 of a 21-day cycle.
357027|NCT01104116|B1|Baseline|PET/CT Imaging|"Surgical patients will undergo [18F]-FDG PET/CT imaging~[18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)"
357028|NCT01104116|P1|Participant Flow|PET/CT Imaging|"Surgical patients will undergo [18F]-FDG PET/CT imaging~[18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)"
357029|NCT01104116|O1|Outcome|PET/CT Imaging|"Surgical patients will undergo [18F]-FDG PET/CT imaging~[18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)"
357030|NCT01104116|O1|Outcome|PET/CT Imaging|"Surgical patients will undergo [18F]-FDG PET/CT imaging~[18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)"
357031|NCT01104116|E1|Reported Event|PET/CT Imaging|"Surgical patients will undergo [18F]-FDG PET/CT imaging~[18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)"
357032|NCT01104103|B3|Baseline|Total|Total of all reporting groups
357033|NCT01104103|B2|Baseline|Standard Care|Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
357034|NCT01104103|B1|Baseline|BOA(R)|Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult
357035|NCT01104103|P2|Participant Flow|Standard Care|Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
357036|NCT01104103|P1|Participant Flow|BOA(R)|Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult
357037|NCT01104103|O2|Outcome|Standard Care|Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
357038|NCT01104103|O1|Outcome|BOA(R)|Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult
357039|NCT01104103|O2|Outcome|Standard Care|Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
357040|NCT01104103|O1|Outcome|BOA(R)|Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult
357041|NCT01104103|E2|Reported Event|Standard Care|Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
357042|NCT01104103|E1|Reported Event|BOA(R)|Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult
357043|NCT01103973|B3|Baseline|Total|Total of all reporting groups
357044|NCT01103973|B2|Baseline|Mind/Body Program|"Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.~Mind/Body Program: Ten week group mind/body program"
357045|NCT01103973|B1|Baseline|Control (Spa Certificate)|"For every three months in the study control subjects received $50 spa gift certificates.~Control: Spa gift certificates"
357172|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
357047|NCT01103973|P1|Participant Flow|Control (Spa Certificate)|"For every three months in the study control subjects received $50 spa gift certificates.~Control: Spa gift certificates"
357048|NCT01103973|O2|Outcome|Mind/Body Program|"Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.~Mind/Body Program: Ten week group mind/body program"
357049|NCT01103973|O1|Outcome|Control (Spa Certificate)|"For every three months in the study control subjects received $50 spa gift certificates.~Control: Spa gift certificates"
357050|NCT01103973|O2|Outcome|Mind/Body Program|"Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.~Mind/Body Program: Ten week group mind/body program"
357051|NCT01103973|O1|Outcome|Control (Spa Certificate)|"For every three months in the study control subjects received $50 spa gift certificates.~Control: Spa gift certificates"
357052|NCT01103973|E2|Reported Event|Mind/Body Program|"Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.~Mind/Body Program: Ten week group mind/body program"
357053|NCT01103973|E1|Reported Event|Control (Spa Certificate)|"For every three months in the study control subjects received $50 spa gift certificates.~Control: Spa gift certificates"
357054|NCT01103960|B3|Baseline|Total|Total of all reporting groups
357055|NCT01103960|B2|Baseline|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
357056|NCT01103960|B1|Baseline|A5 Alone|Amlodipine 5mg monotherapy
357057|NCT01103960|P2|Participant Flow|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
357058|NCT01103960|P1|Participant Flow|A5 Alone|Amlodipine 5mg monotherapy
357059|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
357060|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
357061|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
357062|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
357063|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
357064|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
357065|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
357066|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
357067|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
357068|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
357069|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
357070|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
357071|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
357072|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
357073|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
357074|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
357075|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
357076|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
357077|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
357078|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
357079|NCT01103960|E2|Reported Event|T80/A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily
357080|NCT01103960|E1|Reported Event|A5 Alone|Amlodipine 5 mg one daily
357081|NCT01103934|B3|Baseline|Total|Total of all reporting groups
357082|NCT01103934|B2|Baseline|Fluticasone Propionate Plus Placebo|"Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season~Placebo: Placebo taken once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
357083|NCT01103934|B1|Baseline|Fluticasone Propionate Plus Vitamin D3|"Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season~Vitamin D3: 4000 IU once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
357084|NCT01103934|P2|Participant Flow|Fluticasone Propionate Plus Placebo|"Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season~Placebo: Placebo taken once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
357085|NCT01103934|P1|Participant Flow|Fluticasone Propionate Plus Vitamin D3|"Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season~Vitamin D3: 4000 IU once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
357086|NCT01103934|O2|Outcome|Fluticasone Propionate Plus Placebo|"Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season~Placebo: Placebo taken once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
357087|NCT01103934|O1|Outcome|Fluticasone Propionate Plus Vitamin D3|"Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season~Vitamin D3: 4000 IU once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
357088|NCT01103934|O2|Outcome|Fluticasone Propionate Plus Placebo|"Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season~Placebo: Placebo taken once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
357089|NCT01103934|O1|Outcome|Fluticasone Propionate Plus Vitamin D3|"Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season~Vitamin D3: 4000 IU once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
357090|NCT01103934|E2|Reported Event|Fluticasone Propionate Plus Placebo|"Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season~Placebo: Placebo taken once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
357091|NCT01103934|E1|Reported Event|Fluticasone Propionate Plus Vitamin D3|"Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season~Vitamin D3: 4000 IU once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
357092|NCT01103713|B1|Baseline|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
357173|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
357093|NCT01103713|P1|Participant Flow|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
357094|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
357095|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
357096|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
357097|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
357098|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
357099|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
357100|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
357101|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
357102|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
357103|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
357104|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
357105|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
357106|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
357107|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
357108|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
357109|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
357110|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
357111|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
357112|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
357113|NCT01103713|O1|Outcome|Azithromycin/Chloroquine (AZCQ)|This is an open label, single arm study conducted in pregnant women during their second and third trimesters of pregnancy. Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
357114|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
357115|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
357116|NCT01103713|E2|Reported Event|Azithromycin/Chloroquine (Familial Status = Mother)|ACZQ (Familial Status = Mother)
357117|NCT01103713|E1|Reported Event|Azithromycin/Chloroquine (Familial Status = Neonate)|AZCQ (Familial Status = Neonate)
357118|NCT01103492|B1|Baseline|Ablation Catheter|Procedure using the HALO90 Ablation catheter to heat a thin layer of rectal tissue using radiofrequency to reduce inflammation and bleeding in subjects with radiation proctitis.
357119|NCT01103492|P1|Participant Flow|Ablation Catheter|Procedure using the HALO90 Ablation catheter to heat a thin layer of rectal tissue using radiofrequency to reduce inflammation and bleeding in subjects with radiation proctitis.
357120|NCT01103492|O1|Outcome|Ablation Treatment|Subjects with radiation proctitis who met inclusion criteria
357121|NCT01103492|E1|Reported Event|Ablation Catheter|Procedure using the HALO90 Ablation catheter to heat a thin layer of rectal tissue using radiofrequency to reduce inflammation and bleeding in subjects with radiation proctitis.
357122|NCT01103479|B4|Baseline|Total|Total of all reporting groups
357123|NCT01103479|B3|Baseline|Physician and Patient Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening~Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening"
357124|NCT01103479|B2|Baseline|Physician Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training~Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training"
357125|NCT01103479|B1|Baseline|Control|Participants will complete interviewer-administered pre- and post-test
357126|NCT01103479|P3|Participant Flow|Physician and Patient Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening~Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening"
357127|NCT01103479|P2|Participant Flow|Physician Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training~Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training"
357128|NCT01103479|P1|Participant Flow|Control|Participants will complete interviewer-administered pre- and post-test
357129|NCT01103479|O2|Outcome|Physician and Patient Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening~Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening"
357130|NCT01103479|O1|Outcome|Physician Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training~Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training"
357131|NCT01103479|O2|Outcome|Intervention|"Participants in either the Physician Intervention or Physician and Patient Intervention Arms.~Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training~Physician and Patient Intervention: Physician intervention as described plus patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening~Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this co"
357132|NCT01103479|O1|Outcome|Control|Participants will complete interviewer-administered pre- and post-test
357133|NCT01103479|O2|Outcome|Physician and Patient Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening~Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening"
357174|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
357175|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
357134|NCT01103479|O1|Outcome|Physician Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training~Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training"
357135|NCT01103479|O2|Outcome|Intervention|"Participants in either the Physician Intervention or Physician and Patient Intervention Arms.~Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training~Physician and Patient Intervention: Physician intervention as described plus patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening~Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this co"
357136|NCT01103479|O1|Outcome|Control|Participants will complete interviewer-administered pre- and post-test
357137|NCT01103479|E3|Reported Event|Physician and Patient Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening~Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening"
357138|NCT01103479|E2|Reported Event|Physician Training|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training~Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training"
357139|NCT01103479|E1|Reported Event|Control|Participants will complete interviewer-administered pre- and post-test
357140|NCT01103466|B1|Baseline|All Study Parcipitants|All parcipitants recieved all three intervention and they are therefore combined into one group.
357141|NCT01103466|P3|Participant Flow|Conform2|"Commercially available base plate~All subjects tested this test product in one period during the study.~No parcipitants recieved the same study intervention more than once"
357142|NCT01103466|P2|Participant Flow|SenSura|"Commercially available base plate~All subjects tested this test product in one period during the study.~No parcipitants recieved the same study intervention more than once"
357143|NCT01103466|P1|Participant Flow|Atlas|"New base plate~All subjects tested this test product in one period during the study.~No parcipitants recieved the same study intervention more than once"
357144|NCT01103466|O3|Outcome|Conform2|base plate
357145|NCT01103466|O2|Outcome|SenSura|base plate
357146|NCT01103466|O1|Outcome|Atlas|new base plate
357147|NCT01103466|E3|Reported Event|Conform2|base plate
357148|NCT01103466|E2|Reported Event|SenSura|base plate
357149|NCT01103466|E1|Reported Event|Atlas|new base plate
357150|NCT01103440|B3|Baseline|Total|Total of all reporting groups
357151|NCT01103440|B2|Baseline|Aggressive Strategy|Patient receive 325mg ASA orally and loading does of 600mg Clopidogrel at time of procedure with addition of IV GP IIb/IIIa inhibitor bolus intra procedurally
357152|NCT01103440|B1|Baseline|Conventional Strategy|Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure
357153|NCT01103440|P2|Participant Flow|Aggressive Strategy|Patient receive 325mg ASA orally and loading does of 600mg Clopidogrel at time of procedure with addition of IV GP IIb/IIIa inhibitor bolus intra procedurally
357154|NCT01103440|P1|Participant Flow|Conventional Strategy|Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure
357155|NCT01103440|O2|Outcome|Aggressive Strategy|Patient receive 325mg ASA orally and loading does of 600mg Clopidogrel at time of procedure with addition of IV GP IIb/IIIa inhibitor bolus intra procedurally
357156|NCT01103440|O1|Outcome|Conventional Strategy|Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure
357157|NCT01103440|O2|Outcome|Aggressive Strategy|Patient receive 325mg ASA orally and loading does of 600mg Clopidogrel at time of procedure with addition of IV GP IIb/IIIa inhibitor bolus intra procedurally
357158|NCT01103440|O1|Outcome|Conventional Strategy|Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure
357159|NCT01103440|E2|Reported Event|Aggressive Strategy|Patient receive 325mg ASA orally and loading does of 600mg Clopidogrel at time of procedure with addition of IV GP IIb/IIIa inhibitor bolus intra procedurally
357160|NCT01103440|E1|Reported Event|Conventional Strategy|Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure
357161|NCT01103414|B6|Baseline|Total|Total of all reporting groups
357162|NCT01103414|B5|Baseline|Matching Placebo|Over-encapsulated placebo tablet
357163|NCT01103414|B4|Baseline|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
357164|NCT01103414|B3|Baseline|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
357165|NCT01103414|B2|Baseline|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
357166|NCT01103414|B1|Baseline|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
357167|NCT01103414|P5|Participant Flow|Matching Placebo|Over-encapsulated placebo tablet
357168|NCT01103414|P4|Participant Flow|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
357169|NCT01103414|P3|Participant Flow|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
357170|NCT01103414|P2|Participant Flow|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
357171|NCT01103414|P1|Participant Flow|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
357178|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
357179|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
357180|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
357181|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
357182|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
357183|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
357184|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
357185|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
357186|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
357187|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
357188|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
357189|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
357190|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
357191|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
357192|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
357193|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
357194|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
357195|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
357196|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
357197|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
357198|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
357199|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
357200|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
357201|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
357202|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
357203|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
357204|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
357205|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
357206|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
357207|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
357208|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
357209|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
357210|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
357211|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
357212|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
357213|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
357214|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
357215|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
357216|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
357217|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
357218|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
357219|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
357220|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
357221|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
357222|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
357223|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
357224|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
357225|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
357226|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
357227|NCT01103414|E5|Reported Event|Matching Placebo|Over-encapsulated placebo tablet
357228|NCT01103414|E4|Reported Event|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
357229|NCT01103414|E3|Reported Event|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
357230|NCT01103414|E2|Reported Event|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
357231|NCT01103414|E1|Reported Event|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
357232|NCT01103362|B1|Baseline|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin: all patients will receive open-label flibanserin 100mg"
357233|NCT01103362|P1|Participant Flow|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin: all patients will receive open-label flibanserin 100mg"
357234|NCT01103362|O1|Outcome|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin: all patients will receive open-label flibanserin 100mg"
357235|NCT01103362|E1|Reported Event|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin: all patients will receive open-label flibanserin 100mg"
357236|NCT01103323|B3|Baseline|Total|Total of all reporting groups
357237|NCT01103323|B2|Baseline|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
357238|NCT01103323|B1|Baseline|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
357239|NCT01103323|P2|Participant Flow|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC). Period 1 is placebo and placebo-regorafenib with placebo period only before unblinding. Period 2 is placebo-regorafenib with regorafenib period only.
357240|NCT01103323|P1|Participant Flow|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
357241|NCT01103323|O2|Outcome|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC)
357242|NCT01103323|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
357243|NCT01103323|O2|Outcome|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC)
357244|NCT01103323|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
357245|NCT01103323|O2|Outcome|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC)
357246|NCT01103323|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
357247|NCT01103323|O2|Outcome|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC)
357248|NCT01103323|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
357249|NCT01103323|O2|Outcome|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC)
357250|NCT01103323|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
357251|NCT01103323|E3|Reported Event|Placebo - Regorafenib After Unblinding|Participants in the placebo+BSC group switched to treatment with Regorafenib after unblinding. It is for Regorafenib treatment period only
357252|NCT01103323|E2|Reported Event|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC). It is for placebo period only before unblinding.
357253|NCT01103323|E1|Reported Event|Regorafenib (BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
357254|NCT01103284|B3|Baseline|Total|Total of all reporting groups
357255|NCT01103284|B2|Baseline|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
357256|NCT01103284|B1|Baseline|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
357257|NCT01103284|P2|Participant Flow|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
357258|NCT01103284|P1|Participant Flow|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
357259|NCT01103284|O2|Outcome|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
357260|NCT01103284|O1|Outcome|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
357261|NCT01103284|O2|Outcome|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
357262|NCT01103284|O1|Outcome|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
357263|NCT01103284|O2|Outcome|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
357264|NCT01103284|O1|Outcome|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
357265|NCT01103284|O2|Outcome|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
357266|NCT01103284|O1|Outcome|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
357267|NCT01103284|O2|Outcome|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
357442|NCT01102803|O2|Outcome|D-Cycloserine|Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
357268|NCT01103284|O1|Outcome|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
357269|NCT01103284|E2|Reported Event|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
357270|NCT01103284|E1|Reported Event|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
357271|NCT01103271|B3|Baseline|Total|Total of all reporting groups
357272|NCT01103271|B2|Baseline|Waitlist Treatment|Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
357273|NCT01103271|B1|Baseline|Immediate Treatment|Participants will begin taking placebo pills for four weeks immediately after enrolling in the study.
357274|NCT01103271|P2|Participant Flow|Waitlist Treatment|Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
357275|NCT01103271|P1|Participant Flow|Immediate Treatment|Participants will begin taking placebo pills for four weeks immediately after enrolling in the study.
357276|NCT01103271|O2|Outcome|Placebo Comparator: Waitlist Treatment|Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
357277|NCT01103271|O1|Outcome|Open Label-Placebo: Immediate Treatment|Participants assigned to immediate treatment will begin taking placebo pills for four weeks immediately after enrolling in the study.
357278|NCT01103271|O1|Outcome|Placebo Effect Study|These were all participants who were screened for the study but not yet enrolled.
357279|NCT01103271|E2|Reported Event|Waitlist Treatment|Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
357280|NCT01103271|E1|Reported Event|Immediate Treatment|Participants will begin taking placebo pills for four weeks immediately after enrolling in the study.
357281|NCT01103232|B3|Baseline|Total|Total of all reporting groups
357282|NCT01103232|B2|Baseline|Control|Transcutaneous electrical nerve stimulation was applied
357283|NCT01103232|B1|Baseline|Experimental|Electrical muscle stimulation of the right wrist flexor muscles was applied
357284|NCT01103232|P2|Participant Flow|Control|Transcutaneous electrical nerve stimulation was applied
357285|NCT01103232|P1|Participant Flow|Experimental|Electrical muscle stimulation of the right wrist flexor muscles was applied
357286|NCT01103232|O2|Outcome|Control|Transcutaneous electrical nerve stimulation was applied
357287|NCT01103232|O1|Outcome|Experimental|Electrical muscle stimulation of the right wrist flexor muscles was applied
357288|NCT01103232|E2|Reported Event|Control|Transcutaneous electrical nerve stimulation was applied
357289|NCT01103232|E1|Reported Event|Experimental|Electrical muscle stimulation of the right wrist flexor muscles was applied
357290|NCT01103141|B3|Baseline|Total|Total of all reporting groups
357291|NCT01103141|B2|Baseline|Routine Access|Standard gauge-18 large-bore needle
357292|NCT01103141|B1|Baseline|Micropuncture|Gauge-21 Micropuncture® needle
357293|NCT01103141|P2|Participant Flow|Routine Access|Standard gauge-18 large-bore needle
357294|NCT01103141|P1|Participant Flow|Micropuncture|Gauge-21 Micropuncture® needle
357295|NCT01103141|O2|Outcome|Routine Access|Standard gauge-18 large-bore needle
357296|NCT01103141|O1|Outcome|Micropuncture|Gauge-21 Micropuncture® needle
357297|NCT01103141|E2|Reported Event|Routine Access|Standard gauge-18 large-bore needle
357298|NCT01103141|E1|Reported Event|Micropuncture|Gauge-21 Micropuncture® needle
357299|NCT01103063|B3|Baseline|Total|Total of all reporting groups
357300|NCT01103063|B2|Baseline|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357301|NCT01103063|B1|Baseline|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357302|NCT01103063|P2|Participant Flow|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357303|NCT01103063|P1|Participant Flow|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357304|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357305|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357306|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357307|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357443|NCT01102803|O1|Outcome|Sugar Pill|Participants will receive sugar pill placebo augmented cognitive behavioral therapy
357308|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357309|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357310|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357311|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357312|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357313|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357314|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357315|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357316|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357317|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357318|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357319|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357320|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357321|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357322|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357323|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357324|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357325|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357326|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357327|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357328|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357373|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357329|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357330|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357331|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357332|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357333|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357334|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357335|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357336|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357337|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357338|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357339|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357340|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357341|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357342|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357343|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357344|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357345|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357346|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357347|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357348|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357349|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357374|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357350|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357351|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357352|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357353|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357354|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357355|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357356|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357357|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357358|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357359|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357360|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357361|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357362|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357363|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357364|NCT01103063|E4|Reported Event|Neonate (Sulfadoxine + Pyrimethamine)|Live births of participants who received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357365|NCT01103063|E3|Reported Event|Neonate (Azithromycin + Chloroquine)|Live births of participants who received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357366|NCT01103063|E2|Reported Event|Mother (Sulfadoxine + Pyrimethamine)|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
357367|NCT01103063|E1|Reported Event|Mother (Azithromycin + Chloroquine)|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
357368|NCT01102972|B3|Baseline|Total|Total of all reporting groups
357369|NCT01102972|B2|Baseline|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357370|NCT01102972|B1|Baseline|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357371|NCT01102972|P2|Participant Flow|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357372|NCT01102972|P1|Participant Flow|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357440|NCT01102803|O2|Outcome|D-Cycloserine|Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
357375|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357376|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357377|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357378|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357379|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357380|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357381|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357382|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357383|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357384|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357385|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357386|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357387|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357388|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357389|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357390|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357391|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357392|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357393|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357394|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357395|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357396|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357397|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357398|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357399|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357400|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357401|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357402|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357403|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357404|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357441|NCT01102803|O1|Outcome|Sugar Pill|Participants will receive sugar pill placebo augmented cognitive behavioral therapy
357405|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357406|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357407|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357408|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357409|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357410|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357411|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357412|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357413|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357414|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357415|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357416|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357417|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357418|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357419|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357420|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357421|NCT01102972|E2|Reported Event|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
357422|NCT01102972|E1|Reported Event|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
357423|NCT01102894|B1|Baseline|Low Fiber and High Fiber|"Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time Subjects also consumed low fiber~SmartPill : SmartPill"
357424|NCT01102894|P1|Participant Flow|High Fiber and Low Fiber|"Subjects consume a low and high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
357425|NCT01102894|O2|Outcome|Low Fiber|"Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
357426|NCT01102894|O1|Outcome|High Fiber|"Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
357427|NCT01102894|O2|Outcome|Low Fiber|"Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
357428|NCT01102894|O1|Outcome|High Fiber|"Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
357429|NCT01102894|O2|Outcome|Low Fiber|"Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
357430|NCT01102894|O1|Outcome|High Fiber|"Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
357431|NCT01102894|E2|Reported Event|Low Fiber|"Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
357432|NCT01102894|E1|Reported Event|High Fiber|"Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
357433|NCT01102803|B3|Baseline|Total|Total of all reporting groups
357434|NCT01102803|B2|Baseline|D-Cycloserine|Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
357435|NCT01102803|B1|Baseline|Sugar Pill|Participants will receive sugar pill placebo augmented cognitive behavioral therapy
357436|NCT01102803|P2|Participant Flow|D-Cycloserine|Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
357437|NCT01102803|P1|Participant Flow|Sugar Pill|Participants will receive sugar pill placebo augmented cognitive behavioral therapy
357438|NCT01102803|O2|Outcome|D-Cycloserine|Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
357439|NCT01102803|O1|Outcome|Sugar Pill|Participants will receive sugar pill placebo augmented cognitive behavioral therapy
360693|NCT01092442|O1|Outcome|Retrospective Ross|
357444|NCT01102803|O2|Outcome|Placebo+CBT Treatment|Participants receiving PL augmented CBT
357445|NCT01102803|O1|Outcome|DCS+CBT Treatment|Participants receiving DCS augmented CBT
357446|NCT01102803|E2|Reported Event|Pill Placebo + CBT|CBT augmented with sugar pill placebo
357447|NCT01102803|E1|Reported Event|DCS+CBT|CBT augmented with DCS (50mg)
357448|NCT01102777|B3|Baseline|Total|Total of all reporting groups
357449|NCT01102777|B2|Baseline|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
357450|NCT01102777|B1|Baseline|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
357451|NCT01102777|P2|Participant Flow|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
357452|NCT01102777|P1|Participant Flow|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
357453|NCT01102777|O2|Outcome|Intervention|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
357454|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
357455|NCT01102777|O2|Outcome|Intervention|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
357456|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
357457|NCT01102777|O2|Outcome|Intervention|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
357458|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
357459|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
357460|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
357461|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
357462|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
357463|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
357464|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
357465|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
357466|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
357467|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
357468|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
357512|NCT01102374|P1|Participant Flow|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357469|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
357470|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
357471|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
357472|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
357473|NCT01102777|E2|Reported Event|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
357474|NCT01102777|E1|Reported Event|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
357475|NCT01102764|B3|Baseline|Total|Total of all reporting groups
357476|NCT01102764|B2|Baseline|Arm 2: PE in Person|"PE in person~In Person: PE therapy delivered in person at the VAMC"
357477|NCT01102764|B1|Baseline|Arm 1: PE Via Telemedicine|"PE via telemedicine~Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
357478|NCT01102764|P2|Participant Flow|Arm 2: PE in Person|"PE in person~In Person: PE therapy delivered in person at the VAMC"
357479|NCT01102764|P1|Participant Flow|Arm 1: PE Via Telemedicine|"PE via telemedicine~Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
357480|NCT01102764|O2|Outcome|Arm 2: PE in Person|"PE in person~In Person: PE therapy delivered in person at the VAMC"
357481|NCT01102764|O1|Outcome|Arm 1: PE Via Telemedicine|"PE via telemedicine~Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
357482|NCT01102764|O2|Outcome|Arm 2: PE in Person|"PE in person~In Person: PE therapy delivered in person at the VAMC"
357483|NCT01102764|O1|Outcome|Arm 1: PE Via Telemedicine|"PE via telemedicine~Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
357484|NCT01102764|O2|Outcome|Arm 2: PE in Person|"PE in person~In Person: PE therapy delivered in person at the VAMC"
357485|NCT01102764|O1|Outcome|Arm 1: PE Via Telemedicine|"PE via telemedicine~Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
357486|NCT01102764|E2|Reported Event|Arm 2: PE in Person|"PE in person~In Person: PE therapy delivered in person at the VAMC"
357487|NCT01102764|E1|Reported Event|Arm 1: PE Via Telemedicine|"PE via telemedicine~Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
357488|NCT01102491|B3|Baseline|Total|Total of all reporting groups
357489|NCT01102491|B2|Baseline|Control|no antiemetic prophylaxis
357490|NCT01102491|B1|Baseline|Ramosetron Prophylaxis|ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
357491|NCT01102491|P2|Participant Flow|Control|no antiemetic prophylaxis
357492|NCT01102491|P1|Participant Flow|Ramosetron Prophylaxis|ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
357493|NCT01102491|O2|Outcome|Control|no antiemetic prophylaxis
357494|NCT01102491|O1|Outcome|Ramosetron Prophylaxis|ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
357495|NCT01102491|E2|Reported Event|Control|no antiemetic prophylaxis
357496|NCT01102491|E1|Reported Event|Ramosetron Prophylaxis|ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
357497|NCT01102413|B3|Baseline|Total|Total of all reporting groups
357498|NCT01102413|B2|Baseline|Iron Sulphate|"Oral intake~Iron Sulphate: Oral intake"
357499|NCT01102413|B1|Baseline|Monofer|"Injections or infusions~Monofer: Infusion or injections"
357500|NCT01102413|P2|Participant Flow|Iron Sulphate|"Oral intake~Iron Sulphate: Oral intake"
357501|NCT01102413|P1|Participant Flow|Monofer|"Injections or infusions~Monofer: Infusion or injections"
357502|NCT01102413|O2|Outcome|Iron Sulphate|"Oral intake~Iron Sulphate: Oral intake"
357503|NCT01102413|O1|Outcome|Monofer|"Injections or infusions~Monofer: Infusion or injections"
357504|NCT01102413|O2|Outcome|Iron Sulphate|"Oral intake~Iron Sulphate: Oral intake"
357505|NCT01102413|O1|Outcome|Monofer|"Injections or infusions~Monofer: Infusion or injections"
357506|NCT01102413|E2|Reported Event|Iron Sulphate|"Oral intake~Iron Sulphate: Oral intake"
357507|NCT01102413|E1|Reported Event|Monofer|"Injections or infusions~Monofer: Infusion or injections"
357508|NCT01102374|B3|Baseline|Total|Total of all reporting groups
357509|NCT01102374|B2|Baseline|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357510|NCT01102374|B1|Baseline|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357511|NCT01102374|P2|Participant Flow|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357513|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357514|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357515|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357516|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357517|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357518|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357519|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357520|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357521|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357522|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357523|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357524|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357525|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357526|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357527|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357528|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357529|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357530|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357531|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357532|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357570|NCT01102218|P2|Participant Flow|Erythropoietin Alone|Standard of care prescribed erythropoietin dose.
358131|NCT01099774|O1|Outcome|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
357533|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357534|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357535|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357536|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357537|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357538|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357539|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357540|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357541|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357542|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357543|NCT01102374|E2|Reported Event|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357544|NCT01102374|E1|Reported Event|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
357545|NCT01102270|B1|Baseline|All Study Participants|all study participants who received all interventions
357546|NCT01102270|P2|Participant Flow|Sugar Pill First, Then Eszopiclone|Placebo : 1 placebo capsule prior to sleep then 3mg eszopiclone 1 week later
357547|NCT01102270|P1|Participant Flow|Eszopiclone First, Then Sugar Pill|Eszopiclone : 3mg tablet once prior to sleep followed by sugar pill (placebo) 1 week later
357548|NCT01102270|O2|Outcome|Sugar Pill|Placebo : 1 placebo capsule prior to sleep
357549|NCT01102270|O1|Outcome|Eszopiclone|Eszopiclone : 3mg tablet once prior to sleep
357550|NCT01102270|O2|Outcome|Sugar Pill|Placebo : 1 placebo capsule prior to sleep
357551|NCT01102270|O1|Outcome|Eszopiclone|Eszopiclone : 3mg tablet once prior to sleep
357552|NCT01102270|O2|Outcome|Sugar Pill|Placebo : 1 placebo capsule prior to sleep
357553|NCT01102270|O1|Outcome|Eszopiclone|Eszopiclone : 3mg tablet once prior to sleep
357554|NCT01102270|O2|Outcome|Sugar Pill|Placebo : 1 placebo capsule prior to sleep
357555|NCT01102270|O1|Outcome|Eszopiclone|Eszopiclone : 3mg tablet once prior to sleep
357556|NCT01102270|E2|Reported Event|Sugar Pill|Placebo : 1 placebo capsule prior to sleep
357557|NCT01102270|E1|Reported Event|Eszopiclone|Eszopiclone : 3mg tablet once prior to sleep
357558|NCT01102257|B3|Baseline|Total|Total of all reporting groups
357559|NCT01102257|B2|Baseline|Olive Oil|5 Gel Capsules of olive oil taken orally daily
357560|NCT01102257|B1|Baseline|Omega-3 Supplement|5 Gel Capsules taken orally to achieve a daily dose of 2000mg EPA and 1000mg DHA
357561|NCT01102257|P2|Participant Flow|Olive Oil|5 Gel Capsules of olive oil to be taken orally daily
357562|NCT01102257|P1|Participant Flow|Omega-3 Supplement|5 Gel Capsules to be taken orally daily to give a total dose of 2000mg EPA and 1000 mg DHA
357563|NCT01102257|O2|Outcome|Olive Oil|5 Gel Capsules of olive oil taken orally daily
357564|NCT01102257|O1|Outcome|Omega-3 Supplement|5 Gel Capsules taken orally to achieve a daily dose of 2000mg EPA and 1000mg DHA
357565|NCT01102257|E2|Reported Event|Olive Oil|5 Gel Capsules of olive oil taken orally daily
357566|NCT01102257|E1|Reported Event|Omega-3 Supplement|5 Gel Capsules taken orally to achieve a daily dose of 2000mg EPA and 1000mg DHA
357567|NCT01102218|B3|Baseline|Total|Total of all reporting groups
357568|NCT01102218|B2|Baseline|Erythropoietin Alone|Standard of care prescribed erythropoietin dose.
357569|NCT01102218|B1|Baseline|Erythropoietin Plus Pentoxifylline|Standard of care prescribed erythropoietin dose plus 400mg oral pentoxifylline once a day.
360694|NCT01092442|O4|Outcome|Prospective RVOT|
357571|NCT01102218|P1|Participant Flow|Erythropoietin Plus Pentoxifylline|Standard of care prescribed erythropoietin dose plus 400mg oral pentoxifylline once a day.
357572|NCT01102218|O2|Outcome|Erythropoietin Alone|Standard of care prescribed erythropoietin dose.
357573|NCT01102218|O1|Outcome|Erythropoietin Plus Pentoxifylline|Standard of care prescribed erythropoietin dose plus 400mg oral pentoxifylline once a day.
357574|NCT01102218|E2|Reported Event|Erythropoietin Alone|Standard of care prescribed erythropoietin dose.
357575|NCT01102218|E1|Reported Event|Erythropoietin Plus Pentoxifylline|Standard of care prescribed erythropoietin dose plus 400mg oral pentoxifylline once a day.
357576|NCT01102140|B3|Baseline|Total|Total of all reporting groups
357577|NCT01102140|B2|Baseline|Control- Sugar Pill|"The control subjects received a matching sugar pill for 12 weeks.~Sugar Pill: Matching sugar pill"
357578|NCT01102140|B1|Baseline|POMx|"The POMx subjects received 1000 mg of oral POMx for 12 weeks.~POMx, pomegranate polyphenol extract: 1000 mg orally once daily."
357579|NCT01102140|P2|Participant Flow|Control- Sugar Pill|"The control subjects received a matching sugar pill for 12 weeks.~Sugar Pill: Matching sugar pill"
357580|NCT01102140|P1|Participant Flow|POMx|"The POMx subjects received 1000 mg of oral POMx for 12 weeks.~POMx, pomegranate polyphenol extract: 1000 mg orally once daily."
357581|NCT01102140|O2|Outcome|Control- Sugar Pill|The control subjects received a matching sugar pill for 12 weeks. Sugar Pill: Matching sugar pill
357582|NCT01102140|O1|Outcome|POMx|"The POMx subjects received 1000 mg of oral POMx for 12 weeks.~POMx, pomegranate polyphenol extract: 1000 mg orally once daily."
357583|NCT01102140|O2|Outcome|Control- Sugar Pill|"The control subjects received a matching sugar pill for 12 weeks.~Sugar Pill: Matching sugar pill"
357584|NCT01102140|O1|Outcome|POMx|"The POMx subjects will receive 1000 mg of oral POMx for 12 weeks.~POMx, pomegranate polyphenol extract: 1000 mg orally once daily."
357585|NCT01102140|O2|Outcome|Control- Sugar Pill|"The control subjects received a matching sugar pill for 12 weeks.~Sugar Pill: Matching sugar pill"
357586|NCT01102140|O1|Outcome|POMx|"The POMx subjects received 1000 mg of oral POMx for 12 weeks.~POMx, pomegranate polyphenol extract: 1000 mg orally once daily."
357587|NCT01102140|O2|Outcome|Control- Sugar Pill|"The control subjects received a matching sugar pill for 12 weeks.~Sugar Pill: Matching sugar pill"
357588|NCT01102140|O1|Outcome|POMx|"The POMx subjects received 1000 mg of oral POMx for 12 weeks.~POMx, pomegranate polyphenol extract: 1000 mg orally once daily."
357589|NCT01102140|E2|Reported Event|Control- Sugar Pill|"The control subjects received a matching sugar pill for 12 weeks.~Sugar Pill: Matching sugar pill"
357590|NCT01102140|E1|Reported Event|POMx|"15 subjects received 1000 mg of oral POMx for 12 weeks.~POMx, pomegranate polyphenol extract: 1000 mg orally once daily."
357591|NCT01101971|B1|Baseline|First Year Medical Students|Pelvic exam video tutorial: Bryden Magee (Meds 2010) and Dr. Robert Reid created an educational DVD © 2009 that outlines a step-by-step approach to the pelvic exam; utilizing real patient video clips and illustrations. Endorsed by the Association of Professors of Obstetrics and Gynaecology of Canada (APOG), this innovation has been shown to improve both knowledge and confidence in medical students learning these skills (Magee 2009). The video content has been posted on the Queen's streaming server and incorporated into a MEdTech community accessible to all Queen's faculty and students affiliated with the School of Medicine (in MEdTech Central see OBGYN Pelvic Exam Module under community courses).
357592|NCT01101971|P1|Participant Flow|First Year Medical Students|Pelvic exam video tutorial: Bryden Magee (Meds 2010) and Dr. Robert Reid created an educational DVD © 2009 that outlines a step-by-step approach to the pelvic exam; utilizing real patient video clips and illustrations. Endorsed by the Association of Professors of Obstetrics and Gynaecology of Canada (APOG), this innovation has been shown to improve both knowledge and confidence in medical students learning these skills (Magee 2009). The video content has been posted on the Queen's streaming server and incorporated into a MEdTech community accessible to all Queen's faculty and students affiliated with the School of Medicine (in MEdTech Central see OBGYN Pelvic Exam Module under community courses).
357593|NCT01101971|O1|Outcome|First Year Medical Students|Pelvic exam video tutorial: Bryden Magee (Meds 2010) and Dr. Robert Reid created an educational DVD © 2009 that outlines a step-by-step approach to the pelvic exam; utilizing real patient video clips and illustrations. Endorsed by the Association of Professors of Obstetrics and Gynaecology of Canada (APOG), this innovation has been shown to improve both knowledge and confidence in medical students learning these skills (Magee 2009). The video content has been posted on the Queen's streaming server and incorporated into a MEdTech community accessible to all Queen's faculty and students affiliated with the School of Medicine (in MEdTech Central see OBGYN Pelvic Exam Module under community courses).
357594|NCT01101971|E1|Reported Event|First Year Medical Students|Pelvic exam video tutorial: Bryden Magee (Meds 2010) and Dr. Robert Reid created an educational DVD © 2009 that outlines a step-by-step approach to the pelvic exam; utilizing real patient video clips and illustrations. Endorsed by the Association of Professors of Obstetrics and Gynaecology of Canada (APOG), this innovation has been shown to improve both knowledge and confidence in medical students learning these skills (Magee 2009). The video content has been posted on the Queen's streaming server and incorporated into a MEdTech community accessible to all Queen's faculty and students affiliated with the School of Medicine (in MEdTech Central see OBGYN Pelvic Exam Module under community courses).
357595|NCT01101958|B3|Baseline|Total|Total of all reporting groups
357596|NCT01101958|B2|Baseline|Treatment Arm--CV Positive|This arm had emphysema and was determined during bronchoscopy to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
357597|NCT01101958|B1|Baseline|Treatment Arm--CV Negative|This arm had emphysema and was determined during bronchoscopy to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
357598|NCT01101958|P2|Participant Flow|Treatment Arm--CV Positive|This arm was determined to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
357599|NCT01101958|P1|Participant Flow|Treatment Arm--CV Negative|This arm was determined to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
357600|NCT01101958|O2|Outcome|Treatment Arm--CV Positive|This arm was determined to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
357601|NCT01101958|O1|Outcome|Treatment Arm--CV Negative|This arm was determined to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
357602|NCT01101958|E2|Reported Event|Treatment Arm--CV Positive|This arm had emphysema and was determined during bronchoscopy to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
357603|NCT01101958|E1|Reported Event|Treatment Arm--CV Negative|This arm had emphysema and was determined during bronchoscopy to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
357604|NCT01101880|B1|Baseline|Treatment (Chemotherapy and Colony Stimulating Factor)|"INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days.~CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days.~Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity.~filgrastim: Given SC~clofarabine: Given IV~cytarabine: Given IV"
357605|NCT01101880|P1|Participant Flow|Treatment (Chemotherapy and Colony Stimulating Factor)|"INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days.~CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days.~Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity.~filgrastim: Given SC~clofarabine: Given IV~cytarabine: Given IV"
357606|NCT01101880|O1|Outcome|Treatment (Chemotherapy and Colony Stimulating Factor)|"INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days.~CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days.~Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity.~filgrastim: Given SC~clofarabine: Given IV~cytarabine: Given IV"
357607|NCT01101880|O1|Outcome|Treatment (Chemotherapy and Colony Stimulating Factor)|"INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days.~CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days.~Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity.~filgrastim: Given SC~clofarabine: Given IV~cytarabine: Given IV"
357608|NCT01101880|O1|Outcome|Treatment (Chemotherapy and Colony Stimulating Factor)|"INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days.~CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days.~Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity.~filgrastim: Given SC~clofarabine: Given IV~cytarabine: Given IV"
357609|NCT01101880|O1|Outcome|Treatment (Chemotherapy and Colony Stimulating Factor)|"INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days.~CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days.~Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity.~filgrastim: Given SC~clofarabine: Given IV~cytarabine: Given IV"
357610|NCT01101880|O1|Outcome|Treatment (Chemotherapy and Colony Stimulating Factor)|"INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days.~CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days.~Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity.~filgrastim: Given SC~clofarabine: Given IV~cytarabine: Given IV"
357611|NCT01101880|O1|Outcome|Treatment (Chemotherapy and Colony Stimulating Factor)|"INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days.~CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days.~Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity.~filgrastim: Given SC~clofarabine: Given IV~cytarabine: Given IV"
357646|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357647|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357648|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357612|NCT01101880|E1|Reported Event|Treatment (Chemotherapy and Colony Stimulating Factor)|"INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days.~CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days.~Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity.~filgrastim: Given SC~clofarabine: Given IV~cytarabine: Given IV"
357613|NCT01101867|B3|Baseline|Total|Total of all reporting groups
357614|NCT01101867|B2|Baseline|Fixed Dose|fixed meal dose of aspart (based upon weight or total daily insulin dose)
357615|NCT01101867|B1|Baseline|Flexible Dose|aspart dose determined based upon carbohydrate intake.
357616|NCT01101867|P2|Participant Flow|Fixed Dose|Fixed meal dose of Insulin Aspart (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively). Half of the TDD was divided into three equal fixed doses given immediately after each meal.
357617|NCT01101867|P1|Participant Flow|Flexible Dose|Insulin Aspart dose is determined based upon carbohydrate intake and is administered immediately post-meal. Prandial insulin was based upon the formula: CIR=400/TDD where CIR refers to the carbohydrate-to-insulin ratio and TDD refers to the total daily calculated dose of insulin (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively).
357618|NCT01101867|O2|Outcome|Fixed Dose|Fixed meal dose of Insulin Aspart (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively). Half of the TDD was divided into three equal fixed doses given immediately after each meal.
357619|NCT01101867|O1|Outcome|Flexible Dose|Insulin Aspart dose is determined based upon carbohydrate intake and is administered immediately post-meal. Prandial insulin was based upon the formula: CIR=400/TDD where CIR refers to the carbohydrate-to-insulin ratio and TDD refers to the total daily calculated dose of insulin (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively).
357620|NCT01101867|O2|Outcome|Fixed Dose|Fixed meal dose of Insulin Aspart (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively). Half of the TDD was divided into three equal fixed doses given immediately after each meal.
357621|NCT01101867|O1|Outcome|Flexible Dose|Insulin Aspart dose is determined based upon carbohydrate intake and is administered immediately post-meal. Prandial insulin was based upon the formula: CIR=400/TDD where CIR refers to the carbohydrate-to-insulin ratio and TDD refers to the total daily calculated dose of insulin (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively).
357622|NCT01101867|O2|Outcome|Aspart Fixed Dose|"fixed meal dose of aspart (based upon weight or total daily insulin dose)~Aspart fixed dose: fixed dose"
357623|NCT01101867|O1|Outcome|Aspart Flexible Dose|"aspart dose determined based upon carbohydrate intake.~Aspart flexible dose: dose based upon carbohydrate intake and total daily requirements"
357624|NCT01101867|O2|Outcome|Fixed Dose|fixed meal dose of aspart (based upon weight or total daily insulin dose)
357625|NCT01101867|O1|Outcome|Flexible Dose|aspart dose determined based upon carbohydrate intake.
357626|NCT01101867|O2|Outcome|Fixed Dose|fixed meal dose of aspart (based upon weight or total daily insulin dose)
357627|NCT01101867|O1|Outcome|Flexible Dose|aspart dose determined based upon carbohydrate intake.
357628|NCT01101867|O2|Outcome|Fixed Dose|fixed meal dose of aspart (based upon weight or total daily insulin dose)
357629|NCT01101867|O1|Outcome|Flexible Dose|aspart dose determined based upon carbohydrate intake.
357630|NCT01101867|E2|Reported Event|Fixed Dose|fixed meal dose of aspart (based upon weight or total daily insulin dose)
357631|NCT01101867|E1|Reported Event|Flexible Dose|aspart dose determined based upon carbohydrate intake.
357632|NCT01101841|B3|Baseline|Total|Total of all reporting groups
357633|NCT01101841|B2|Baseline|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357634|NCT01101841|B1|Baseline|Brisdelle (Paroxetine Mesylate) Capsules|"Experimental~Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."
357635|NCT01101841|P2|Participant Flow|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357636|NCT01101841|P1|Participant Flow|Brisdelle (Paroxetine Mesylate) Capsules|"Experimental~Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."
357637|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357638|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357639|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357640|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357641|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357642|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357643|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357644|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357645|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357649|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357650|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357651|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357652|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357653|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357654|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357655|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357656|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357657|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357658|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357659|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357660|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357661|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357662|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either MesaBrisdelle (paroxetine mesylate) Capsules fem or placebo capsules in a 1:1 ratio.
357663|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357664|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357665|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357666|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357667|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357668|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357669|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357670|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357671|NCT01101841|E2|Reported Event|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
357672|NCT01101841|E1|Reported Event|Brisdelle (Paroxetine Mesylate) Capsules|"Experimental~Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."
357673|NCT01101542|B1|Baseline|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
357674|NCT01101542|P1|Participant Flow|Cervarix Group|Subjects who received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
357675|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
357676|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
357677|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
357678|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
358132|NCT01099774|O2|Outcome|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
357679|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
357680|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
357681|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
357682|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
357683|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
357684|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
357685|NCT01101542|E4|Reported Event|Cervarix Year 6 Group|Subjects enrolled for surveillance Year 6, who received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
357686|NCT01101542|E3|Reported Event|Cervarix Year 5 Group|Subjects enrolled for surveillance Year 5, who received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
357687|NCT01101542|E2|Reported Event|Cervarix Year 4 Group|Subjects enrolled for surveillance Year 4, who received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
357688|NCT01101542|E1|Reported Event|Cervarix Year 3 Group|Subjects enrolled for surveillance Year 3, who received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
357689|NCT01101477|B4|Baseline|Total|Total of all reporting groups
357690|NCT01101477|B3|Baseline|Titration by Cet 0.1μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
357691|NCT01101477|B2|Baseline|Titration by Cet 0.2μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
357692|NCT01101477|B1|Baseline|Titration by Target Effect Site Concentration (Cet) 0.5μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
357693|NCT01101477|P3|Participant Flow|Titration by Cet 0.1μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
357694|NCT01101477|P2|Participant Flow|Titration by Cet 0.2μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
357695|NCT01101477|P1|Participant Flow|Titration by Target Effect Site Concentration (Cet) 0.5μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
357696|NCT01101477|O3|Outcome|Titration by Cet 0.1μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
357697|NCT01101477|O2|Outcome|Titration by Cet 0.2μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
357698|NCT01101477|O1|Outcome|Titration by Target Effect Site Concentration (Cet) 0.5μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
357699|NCT01101477|E3|Reported Event|Titration by Cet 0.1μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
357700|NCT01101477|E2|Reported Event|Titration by Cet 0.2μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
358134|NCT01099774|O2|Outcome|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
357701|NCT01101477|E1|Reported Event|Titration by Target Effect Site Concentration (Cet) 0.5μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
357702|NCT01101464|B3|Baseline|Total|Total of all reporting groups
357703|NCT01101464|B2|Baseline|Asenapine, (1) 15 mg Then (3) 5 mg|One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days
357704|NCT01101464|B1|Baseline|Asenapine, (3) 5 mg Then (1) 15 mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days
357705|NCT01101464|P2|Participant Flow|Asenapine, (1) 15 mg Then (3) 5 mg|One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days.
357706|NCT01101464|P1|Participant Flow|Asenapine, (3) 5mg Then (1) 15 mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days.
357707|NCT01101464|O2|Outcome|Asenapine 1x15mg|One 15 mg sublingual tablet given twice daily for 2 or 1.5 days (depending on sequence of participant).
357708|NCT01101464|O1|Outcome|Asenapine 3x5mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 or 1.5 days (depending on sequence of participant).
357709|NCT01101464|O2|Outcome|Asenapine 1x15mg|One 15 mg sublingual tablet given twice daily for 2 or 1.5 days (depending on sequence of participant)
357710|NCT01101464|O1|Outcome|Asenapine 3x5mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 or 1.5 days (depending on sequence of participant)
357711|NCT01101464|O2|Outcome|Asenapine 1x15mg|One 15 mg sublingual tablet given twice daily for 2 or 1.5 days (depending on sequence of participant)
357712|NCT01101464|O1|Outcome|Asenapine 3x5mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 or 1.5 days (depending on sequence of participant)
357713|NCT01101464|E2|Reported Event|Asenapine, (1) 15 mg Then (3) 5 mg|One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days.
357714|NCT01101464|E1|Reported Event|Asenapine, (3) 5 mg Then (1) 15 mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days
357715|NCT01101321|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
357716|NCT01101321|P2|Participant Flow|Reformulated OXY (Wilson) (Reference) First|Reformulated OXY 80-mg tablet (Wilson) (Reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Wilson) (Reference) in period 1 and Reformulated OXY (Totowa) (Test) in period 2.
357717|NCT01101321|P1|Participant Flow|Reformulated OXY (Totowa) (Test) First|Reformulated OXY 80-mg tablet (Totowa)(Test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Totowa) (Test) in period 1 and Reformulated OXY (Wilson) (Reference) in period 2.
357718|NCT01101321|O2|Outcome|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 80-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357719|NCT01101321|O1|Outcome|Reformulated OXY (Totowa) (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357720|NCT01101321|O2|Outcome|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 80-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357721|NCT01101321|O1|Outcome|Reformulated OXY (Totowa) (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357722|NCT01101321|O2|Outcome|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 80-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357723|NCT01101321|O1|Outcome|Reformulated OXY (Totowa) (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357724|NCT01101321|E2|Reported Event|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 80-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357725|NCT01101321|E1|Reported Event|Reformulated OXY (Totowa) (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357726|NCT01101308|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
357727|NCT01101308|P2|Participant Flow|Reformulated OXY 10 mg (Wilson) (Reference) First|Reformulated OXY 10-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received reformulated OXY (Wilson) (Reference) in period 1 and reformulated OXY (Totowa) (Test) in period 2.
357728|NCT01101308|P1|Participant Flow|Reformulated OXY 10 mg (Totowa) (Test) First|Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received reformulated OXY (Totowa) (Test) in period 1 and reformulated OXY (Wilson) (Reference)in period 2.
357729|NCT01101308|O2|Outcome|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 10-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357730|NCT01101308|O1|Outcome|Reformulated OXY (Totowa) (Test)|Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357731|NCT01101308|O2|Outcome|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 10-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357732|NCT01101308|O1|Outcome|Reformulated OXY (Totowa) (Test)|Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357733|NCT01101308|O2|Outcome|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 10-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357734|NCT01101308|O1|Outcome|Reformulated OXY (Totowa) (Test)|Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357735|NCT01101308|E3|Reported Event|Prerandomization|
357736|NCT01101308|E2|Reported Event|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 10-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357737|NCT01101308|E1|Reported Event|Reformulated OXY (Totowa) (Test)|Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357738|NCT01101191|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
357739|NCT01101191|P2|Participant Flow|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
357740|NCT01101191|P1|Participant Flow|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
357741|NCT01101191|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357742|NCT01101191|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357743|NCT01101191|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357744|NCT01101191|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357745|NCT01101191|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357746|NCT01101191|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357747|NCT01101191|E3|Reported Event|Prerandomization|
357748|NCT01101191|E2|Reported Event|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
357749|NCT01101191|E1|Reported Event|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
357750|NCT01101178|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
357751|NCT01101178|P2|Participant Flow|Original OxyContin® (OXY) (Reference) First|Original OxyContin® (OXY) 80-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Original OxyContin(OXY)(Reference)in period 1 and Reformulated OXY (Test) in period 2.
357752|NCT01101178|P1|Participant Flow|Reformulated OXY (Test) First|Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Test) in period 1 and Original OxyContin(OXY)(Reference) in period 2.
357753|NCT01101178|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (oxycodone [OXY]) 80-mg tablet (reference) fed, dose administered in a 2-period, 2-sequence, single-dose, 2-way crossover fashion.
357754|NCT01101178|O1|Outcome|Reformulated Oxycodone (OXY) (Test)|Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357755|NCT01101178|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (oxycodone [OXY]) 80-mg tablet (reference) fed, dose administered in a 2-period, 2-sequence, single-dose, 2-way crossover fashion.
357756|NCT01101178|O1|Outcome|Reformulated Oxycodone (OXY) (Test)|Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357757|NCT01101178|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (oxycodone [OXY]) 80-mg tablet (reference) fed, dose administered in a 2-period, 2-sequence, single-dose, 2-way crossover fashion.
357758|NCT01101178|O1|Outcome|Reformulated Oxycodone (OXY) (Test)|Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357759|NCT01101178|E3|Reported Event|Screening|
357760|NCT01101178|E2|Reported Event|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
357761|NCT01101178|E1|Reported Event|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
357762|NCT01101165|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
357763|NCT01101165|P2|Participant Flow|Original OxyContin® (OXY) (Reference) First|Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Original OxyContin(OXY)(Reference)in period 1 and Reformulated OXY (Test) in period 2.
357914|NCT01100723|O1|Outcome|Results Analyzed at Study Evaluation Time Points.|Results analyzed at study evaluation time points of 1 year and 6 months.
357764|NCT01101165|P1|Participant Flow|Reformulated OXY (Test) First|Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Test) in period 1 and Original OxyContin(OXY)(Reference) in period 2.
357765|NCT01101165|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357766|NCT01101165|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357767|NCT01101165|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357768|NCT01101165|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357769|NCT01101165|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357770|NCT01101165|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357771|NCT01101165|E2|Reported Event|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357772|NCT01101165|E1|Reported Event|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
357773|NCT01101022|B3|Baseline|Total|Total of all reporting groups
357774|NCT01101022|B2|Baseline|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
357775|NCT01101022|B1|Baseline|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
357776|NCT01101022|P2|Participant Flow|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
357777|NCT01101022|P1|Participant Flow|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
357778|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
357779|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
357780|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
357781|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
357782|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
357783|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
357784|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
357785|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
357786|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
357787|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
357788|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
357789|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
357790|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
357791|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
357792|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
357793|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
357794|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
357795|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
357796|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
357797|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
357798|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
357799|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
357800|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
357801|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
357802|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
360818|NCT01091519|B3|Baseline|Total|Total of all reporting groups
357803|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
357804|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
357805|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
357806|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
357807|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
357808|NCT01101022|E2|Reported Event|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
357809|NCT01101022|E1|Reported Event|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
357810|NCT01100944|B1|Baseline|All Participants|All participants who had at least one dose of Belinostat.
357811|NCT01100944|P3|Participant Flow|Belinostat and Chemotherapy at the Maximum Tolerated Dose(MTD)|Patients were treated with belinostat, doxorubicin, cisplatin and cyclophosphamide at the maximum tolerated dose derived from the phase I dose level.
357812|NCT01100944|P2|Participant Flow|Belinostat 500mg/m(2) and Chemotherapy|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
357813|NCT01100944|P1|Participant Flow|Belinostat 250mg/m(2) and Chemotherapy|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
357814|NCT01100944|O1|Outcome|All Participants|"Patients received 250mg/m(2) or 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
357815|NCT01100944|O1|Outcome|All Participants|"Patients received 250mg/m(2) or 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
357816|NCT01100944|O1|Outcome|All Participants|"Patients received 250mg/m(2) or 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
357817|NCT01100944|O2|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
357818|NCT01100944|O1|Outcome|Phase I Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
357882|NCT01100853|O1|Outcome|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
357883|NCT01100853|O2|Outcome|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
357819|NCT01100944|O2|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
357820|NCT01100944|O1|Outcome|Phase I Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
357821|NCT01100944|O2|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
357822|NCT01100944|O1|Outcome|Phase I Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
357823|NCT01100944|O2|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
357824|NCT01100944|O1|Outcome|Phase I Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
357825|NCT01100944|O2|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
357826|NCT01100944|O1|Outcome|Phase I Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
357827|NCT01100944|O2|Outcome|Phase 1 Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
357828|NCT01100944|O1|Outcome|Phase 1 Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
357829|NCT01100944|O2|Outcome|Phase 1 Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
357830|NCT01100944|O1|Outcome|Phase 1 Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
357831|NCT01100944|O3|Outcome|Thymic and Thymoma Participants|"All participants who had at least one dose of belinostat. PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
357832|NCT01100944|O2|Outcome|Thymoma Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
357833|NCT01100944|O1|Outcome|Thymic Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
357834|NCT01100944|O3|Outcome|Thymic and Thymoma Participants|"All participants who had at least one dose of belinostat.~PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
357835|NCT01100944|O2|Outcome|Thymoma Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
357836|NCT01100944|O1|Outcome|Thymic Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
357884|NCT01100853|O1|Outcome|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
357885|NCT01100853|E2|Reported Event|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
357915|NCT01100723|O1|Outcome|Post Treatment|Results analyzed at study evaluation time points.
357837|NCT01100944|O3|Outcome|Thymic and Thymoma Participants|"All participants who had at least one dose of belinostat. PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
357838|NCT01100944|O2|Outcome|Thymoma Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
357839|NCT01100944|O1|Outcome|Thymic Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
357840|NCT01100944|O1|Outcome|Phase I Dose Level 1 & Phase I Dose Level 2|"Patients received 250mg/m(2) or 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
357841|NCT01100944|O3|Outcome|Thymic and Thymoma Participants|"All participants who had at least one dose of belinostat. PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
357842|NCT01100944|O2|Outcome|Thymoma Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
357843|NCT01100944|O1|Outcome|Thymic Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
357844|NCT01100944|O3|Outcome|Thymic and Thymoma Participants|"All participants who had at least one dose of belinostat.~PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
357886|NCT01100853|E1|Reported Event|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
357916|NCT01100723|E1|Reported Event|Post Treatment|Results analyzed at study evaluation time points.
357845|NCT01100944|O2|Outcome|Thymoma Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
357846|NCT01100944|O1|Outcome|Thymic Particpants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
357847|NCT01100944|O3|Outcome|All Participants|All participants who had at least one dose of belinostat.
357848|NCT01100944|O2|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
357849|NCT01100944|O1|Outcome|Phase I Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD) and was utilized in the expansion phase (phase 2)."
357850|NCT01100944|O1|Outcome|All Participants|"All participants who had at least one dose of belinostat. PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
357851|NCT01100944|O3|Outcome|Thymic and Thymoma Participants|"All participants who had at least one dose of belinostat. PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
357852|NCT01100944|O2|Outcome|Thymoma Participants|The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
357853|NCT01100944|O1|Outcome|Thymic Participants|The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
357854|NCT01100944|O1|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
357910|NCT01100723|O1|Outcome|Post Treatment|Results analyzed at study evaluation time points.
357911|NCT01100723|O1|Outcome|Post Treatment|Results analyzed at study evaluation time points.
357912|NCT01100723|O1|Outcome|Post Treatment|Results analyzed at study evaluation time points.
357913|NCT01100723|O1|Outcome|Post Treatment|Results analyzed at study evaluation time points.
357855|NCT01100944|O1|Outcome|Phase I Dose Level 1 & Phase I Dose Level 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
357856|NCT01100944|E1|Reported Event|All Participants|All participants who had at least one dose of belinostat.
357857|NCT01100931|B3|Baseline|Total|Total of all reporting groups
357858|NCT01100931|B2|Baseline|Phase II|Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
357859|NCT01100931|B1|Baseline|Phase I|Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
357860|NCT01100931|P2|Participant Flow|Phase II|Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
357861|NCT01100931|P1|Participant Flow|Phase I|Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
357862|NCT01100931|O2|Outcome|Phase II|Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
357863|NCT01100931|O1|Outcome|Phase I|Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
357864|NCT01100931|O1|Outcome|Phase II|Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
357865|NCT01100931|O1|Outcome|Phase I|Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
357866|NCT01100931|E2|Reported Event|Phase II|Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
357867|NCT01100931|E1|Reported Event|Phase I|Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
357868|NCT01100853|B3|Baseline|Total|Total of all reporting groups
357869|NCT01100853|B2|Baseline|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
357870|NCT01100853|B1|Baseline|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
357871|NCT01100853|P2|Participant Flow|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
357872|NCT01100853|P1|Participant Flow|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
357873|NCT01100853|O2|Outcome|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
357874|NCT01100853|O1|Outcome|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
357875|NCT01100853|O2|Outcome|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
357876|NCT01100853|O1|Outcome|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
357877|NCT01100853|O2|Outcome|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
357878|NCT01100853|O1|Outcome|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
357879|NCT01100853|O2|Outcome|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
357880|NCT01100853|O1|Outcome|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
357881|NCT01100853|O2|Outcome|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
360984|NCT01091116|O5|Outcome|Placebo|two doses
357887|NCT01100762|B1|Baseline|Single Group|"In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.~In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject’s preferred speed on the treadmill for 20 minutes.~In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions."
357888|NCT01100762|P1|Participant Flow|Single Group|"In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.~In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject’s preferred speed on the treadmill for 20 minutes.~In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions."
357889|NCT01100762|O3|Outcome|CES and Treadmill|In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
357890|NCT01100762|O2|Outcome|Treadmill|In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
357891|NCT01100762|O1|Outcome|Cranial Electric Stimulation (CES)|In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
357892|NCT01100762|O3|Outcome|CES and Treadmill|In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
357893|NCT01100762|O2|Outcome|Treadmill|In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
357894|NCT01100762|O1|Outcome|Cranial Electric Stimulation (CES)|In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
357895|NCT01100762|O3|Outcome|CES and Treadmill|In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
357896|NCT01100762|O2|Outcome|Treadmill|In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
357897|NCT01100762|O1|Outcome|Cranial Electric Stimulation (CES)|In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
357898|NCT01100762|O3|Outcome|CES and Treadmill|In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
357899|NCT01100762|O2|Outcome|Treadmill|In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
357900|NCT01100762|O1|Outcome|Cranial Electric Stimulation (CES)|In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
357901|NCT01100762|O3|Outcome|CES and Treadmill|In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
357902|NCT01100762|O2|Outcome|Treadmill|In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
357903|NCT01100762|O1|Outcome|Cranial Electric Stimulation (CES)|In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
357904|NCT01100762|O3|Outcome|CES and Treadmill|In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
357905|NCT01100762|O2|Outcome|Treadmill|In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
357906|NCT01100762|O1|Outcome|Cranial Electric Stimulation (CES)|In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
357907|NCT01100762|E1|Reported Event|Single Group|"In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.~In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject’s preferred speed on the treadmill for 20 minutes.~In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions."
357908|NCT01100723|B1|Baseline|Post Treatment|Results analyzed at study evaluation time points.
357909|NCT01100723|P1|Participant Flow|Post Treatment|Patients had their mineral and bone disorders managed by the computer directed algorithm. Cinacalcet dose was increased starting at 30 mg/day as indicated by protocol along with active vitamin D based on values of serum calcium, phosphorus and parathyroid hormone.
360985|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
357917|NCT01100658|B1|Baseline|Participant With Attention Deficit|Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
357918|NCT01100658|P1|Participant Flow|Participant With Attention Deficit|Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
357919|NCT01100658|O1|Outcome|Participant With Attention Deficit|Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
357920|NCT01100658|O1|Outcome|Participant With Attention Deficit|Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
357921|NCT01100658|E1|Reported Event|Participant With Attention Deficit|Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
357922|NCT01100606|B1|Baseline|Entire Study Population|Includes all enrolled participants who received EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) mixed with a small amount of apple juice using a syringe nurser first and EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) mixed with a small amount of apple sauce using a spoon first.
357923|NCT01100606|P2|Participant Flow|EUR-1008 (APT-1008) in Apple Sauce First, Then in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in first treatment period followed by EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in second treatment period. Total dose was not to exceed 10,000 lipase units/kg/day.
357924|NCT01100606|P1|Participant Flow|EUR-1008 (APT-1008) in Apple Juice First, Then in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in first treatment period followed by EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in second treatment period. Total dose was not to exceed 10,000 lipase units/kilogram body weight/day (lipase units/kg/day).
357925|NCT01100606|O1|Outcome|Entire Study Population|Includes all enrolled participants who received EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) mixed with a small amount of apple juice using a syringe nurser first and EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) mixed with a small amount of apple sauce using a spoon first.
357926|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsules) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily with dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
357927|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsules) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily with dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
357928|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
357929|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
357930|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
357931|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
357932|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
357933|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
357934|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
357935|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
357936|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
357937|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
357938|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
357939|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
357940|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
357941|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
357942|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
357943|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
357944|NCT01100606|E3|Reported Event|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
357945|NCT01100606|E2|Reported Event|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
357946|NCT01100606|E1|Reported Event|Zenpep®|Zenpep® 5,000 from open capsule, mixed with a small amount of apple sauce, orally daily in the screening period for 10 days.
357947|NCT01100567|B3|Baseline|Total|Total of all reporting groups
357948|NCT01100567|B2|Baseline|Placebo|Randomized to sham platform 10 min daily
357949|NCT01100567|B1|Baseline|LMMS|Randomized to 10 min LMMS daily
357950|NCT01100567|P2|Participant Flow|Placebo|Randomized to sham platform 10 min daily
357951|NCT01100567|P1|Participant Flow|LMMS|Randomized to 10 min LMMS daily
357952|NCT01100567|O2|Outcome|Placebo|Randomized to sham platform 10 min daily
357953|NCT01100567|O1|Outcome|LMMS|Randomized to 10 min LMMS daily
357954|NCT01100567|O2|Outcome|Placebo|Randomized to sham platform 10 min daily
357955|NCT01100567|O1|Outcome|LMMS|Randomized to 10 min LMMS daily
357956|NCT01100567|E2|Reported Event|Placebo|Randomized to sham platform 10 min daily
357957|NCT01100567|E1|Reported Event|LMMS|Randomized to 10 min LMMS daily
357958|NCT01100502|B3|Baseline|Total|Total of all reporting groups
357959|NCT01100502|B2|Baseline|Placebo|placebo every 3 weeks by IV infusion
357960|NCT01100502|B1|Baseline|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
357961|NCT01100502|P2|Participant Flow|Placebo|placebo every 3 weeks by IV infusion
357962|NCT01100502|P1|Participant Flow|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
357963|NCT01100502|O2|Outcome|Placebo|placebo every 3 weeks by IV infusion
357964|NCT01100502|O1|Outcome|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
357965|NCT01100502|O2|Outcome|Placebo|placebo every 3 weeks by IV infusion
357966|NCT01100502|O1|Outcome|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
357967|NCT01100502|O2|Outcome|Placebo|placebo every 3 weeks by IV infusion
357968|NCT01100502|O1|Outcome|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
357969|NCT01100502|E2|Reported Event|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
357970|NCT01100502|E1|Reported Event|Placebo|placebo every 3 weeks by IV infusion
357971|NCT01100437|B1|Baseline|Entire Study Population|EMBEDA (morphine sulfate plus naltrexone hydrochloride) ER capsule(s) were administered orally once or twice a day (20 mg to 120 mg). During the titration and stabilization phase EMBEDA was administered and titrated to a dose that adequately managed the participant’s pain up to 35 days. The participants then started the Maintenance Phase and were administered the established stable dose of EMBEDA for a minimum of 7 days up to 28 days. Eligible participants were randomized into the 2 treatment groups.
357972|NCT01100437|P3|Participant Flow|EMBEDA Capsule|EMBEDA (morphine sulfate plus naltrexone hydrochloride) ER capsule(s) were administered orally once or twice a day (20 mg to 120 mg). During the titration and stabilization phase EMBEDA was administrated and titrated to a dose that adequately managed the participants pain for up to 35 days. In the Maintenance Phase the participant’s were administered the established stable dose for a minimum of 7 days up to 28 days. Participants were not randomized to treatment phase.
357973|NCT01100437|P2|Participant Flow|EMBEDA Solution Then EMBEDA Capsule|EMBEDA (morphine sulfate plus naltrexone hydrochloride) ER capsule(s) were administered orally once or twice a day (20 mg to 120 mg). During the open label titration and stabilization phase EMBEDA was administered and titrated to a dose that adequately managed the participants pain up to 35 days. In the open label Maintenance Phase the participants were administered the established stable dose for a minimum of 7 days up to 28 days. The participant was then randomized to one of two double-blind treatment sequences for the Treatment Phase. During the Treatment Phase the participant was administered crushed EMBEDA capsules orally at participants stable dose mixed in solution along with matched placebo capsules in the first intervention period. In the second intervention period the participant received whole EMBEDA capsules administered orally at participant’s stable dose along with matched placebo solution.
357974|NCT01100437|P1|Participant Flow|EMBEDA Capsule Then EMBEDA Solution|EMBEDA (morphine sulfate plus naltrexone hydrochloride) Extended Release (ER) capsule(s) were administered orally once or twice a day (20 milligrams [mg] to 120 mg). During the open label titration and stabilization phase EMBEDA was administered and titrated to a dose that adequately managed the participants pain up to 35 days. In the open label Maintenance Phase the participant was administered the established stable dose for a minimum of 7 days up to 28 days. The participant was then randomized to one of two double-blind treatment sequences for the Treatment Phase. During the Treatment Phase the participant was administered whole EMBEDA capsules orally at participant’s stable dose along with a matched placebo solution in the first intervention period. In the second intervention period the participant received crushed EMBEDA capsules that were mixed in solution and administered orally at participant's stable dose along with matched placebo capsules.
357975|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
357976|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
357977|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
357978|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
357979|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
357980|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
357981|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
357982|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
357983|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
357984|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
357985|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
357986|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
357987|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
357988|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
357989|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
357990|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
357991|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
357992|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
357993|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
357994|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
357995|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
357996|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
357997|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
357998|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
357999|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
358000|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
358001|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
358002|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
358003|NCT01100437|O1|Outcome|EMBEDA Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
358004|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
358005|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
358006|NCT01100437|E4|Reported Event|EMBEDA Capsules Maintenance Period|EMBEDA capsule(s) administered orally once or twice a day dose (20 mg go 120 mg) at the participants stable dose for 7 days minimum.
358007|NCT01100437|E3|Reported Event|EMBEDA Capsule Titration/Stabilization Period|EMBEDA capsule(s) administered orally once or twice a day (20 mg go 120 mg) to adequately manage the participants pain.
358008|NCT01100437|E2|Reported Event|EMBEDA Crushed in Solution Treatment Period|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo whole capsules in any treatment period .
358009|NCT01100437|E1|Reported Event|EMBEDA Whole Capsule Treatment Period|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
358010|NCT01100320|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
358011|NCT01100320|P2|Participant Flow|Original OxyContin® (OXY) (Reference) First|Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Original OxyContin® (OXY) (Reference)in period 1 and Reformulated OXY (Test) in period 2.
358012|NCT01100320|P1|Participant Flow|Reformulated OXY (Test) First|Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Test) in period 1 and Original OxyContin(OXY)(Reference) in period 2.
358013|NCT01100320|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
358014|NCT01100320|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
358015|NCT01100320|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
358016|NCT01100320|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
358017|NCT01100320|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
358018|NCT01100320|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
358019|NCT01100320|E2|Reported Event|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
358020|NCT01100320|E1|Reported Event|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
358021|NCT01100307|B3|Baseline|Total|Total of all reporting groups
358022|NCT01100307|B2|Baseline|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
358023|NCT01100307|B1|Baseline|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
358024|NCT01100307|P2|Participant Flow|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
358025|NCT01100307|P1|Participant Flow|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
358062|NCT01100307|E4|Reported Event|Sham Conversion (Week 24 to Week 54)|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
358133|NCT01099774|O1|Outcome|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
358026|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
358027|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
358028|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
358029|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
358030|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
358031|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
358032|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
358033|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
358034|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
358035|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
358036|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
358037|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
358038|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
358039|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
358040|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
358041|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
358042|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
358043|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
358044|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
358045|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
358046|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
358047|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
358048|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
358049|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
358050|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
358051|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
358052|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
358053|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
358054|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
358055|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
358056|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
358057|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
358058|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
358059|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
358060|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
358061|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
358063|NCT01100307|E3|Reported Event|Pegaptanib Sodium (Baseline to Week 54)|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
358064|NCT01100307|E2|Reported Event|Sham (Baseline to Week 24)|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication.
358065|NCT01100307|E1|Reported Event|Pegaptanib Sodium (Baseline to Week 24)|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24).
358066|NCT01100268|B1|Baseline|Methylphenidate ER|Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
358067|NCT01100268|P1|Participant Flow|Methylphenidate ER|Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
358068|NCT01100268|O1|Outcome|Methylphenidate ER|Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
358069|NCT01100268|O1|Outcome|Methylphenidate ER|Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
358070|NCT01100268|E1|Reported Event|Methylphenidate ER|Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
358071|NCT01100255|B3|Baseline|Total|Total of all reporting groups
358072|NCT01100255|B2|Baseline|Group B|IV saline infusion over 40 minutes then 0.5mg/kg IV ketamine infusion over 40 minutes
358073|NCT01100255|B1|Baseline|Group A|0.5mg/kg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes
358074|NCT01100255|P2|Participant Flow|Group B|IV saline infusion over 40 minutes then 0.5mg/kg IV ketamine infusion over 40 minutes
358075|NCT01100255|P1|Participant Flow|Group A|0.5mg/kg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes
358076|NCT01100255|O2|Outcome|Ketamine Infusion|"0.5mg/kg IV infusion over 40 minutes~Ketamine infusion: 0.5mg/kg IV over 40 minutes"
358077|NCT01100255|O1|Outcome|Saline Infusion|"IV saline infusion over 40 minutes~Saline: saline infusion"
358078|NCT01100255|E2|Reported Event|Ketamine Infusion|0.5mg/kg IV ketamine infusion over 40 minutes
358079|NCT01100255|E1|Reported Event|Saline Infusion|IV saline infusion over 40 minutes
358080|NCT01100242|B1|Baseline|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One full course is comprised of 21 days.
358081|NCT01100242|P1|Participant Flow|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One full course is comprised of 21 days.
358082|NCT01100242|O1|Outcome|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One course is comprised of 21 days.
358083|NCT01100242|O1|Outcome|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One course is comprised of 21 days.
358084|NCT01100242|O1|Outcome|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One course is comprised of 21 days.
358085|NCT01100242|E1|Reported Event|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One full course is comprised of 21 days.
358086|NCT01100112|B1|Baseline|Budesonide|"Budesonide-MMX 9 mg tablet~Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
358087|NCT01100112|P1|Participant Flow|Budesonide|"Budesonide-multi-matrix system (MMX) 9 mg tablet~Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
358088|NCT01100112|O1|Outcome|Budesonide|"Budesonide-MMX 9 mg tablet~Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
358089|NCT01100112|O1|Outcome|Budesonide|"Budesonide-MMX 9 mg tablet~Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
358090|NCT01100112|O1|Outcome|Budesonide|"Budesonide-MMX 9 mg tablet~Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
358091|NCT01100112|O1|Outcome|Budesonide|"Budesonide-MMX 9 mg tablet~Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
358092|NCT01100112|E1|Reported Event|Budesonide|"Budesonide-MMX 9 mg tablet~Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
358093|NCT01100086|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
358094|NCT01100086|P2|Participant Flow|Original OxyContin® (OXY) (Reference) First|Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted was administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Original OxyContin® (OXY) (Reference)in period 1 and Reformulated OXY (Test) in period 2.
358095|NCT01100086|P1|Participant Flow|Reformulated OXY (Test) First|Reformulated OXY 10-mg tablet (test) dosed fasted was administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Test) in period 1 and Original OxyContin(OXY)(Reference) in period 2.
358096|NCT01100086|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
358097|NCT01100086|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
358098|NCT01100086|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
358099|NCT01100086|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
358100|NCT01100086|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
358101|NCT01100086|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
358102|NCT01100086|E2|Reported Event|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
358103|NCT01100086|E1|Reported Event|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
358104|NCT01100073|B1|Baseline|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
358105|NCT01100073|P1|Participant Flow|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use. The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
358106|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
358107|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
358108|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
358109|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
358110|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
358111|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
358112|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
358113|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
358114|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
358115|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
358116|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
358117|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
358118|NCT01100073|E1|Reported Event|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
358119|NCT01099917|B1|Baseline|Maitake|This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
358120|NCT01099917|P1|Participant Flow|Maitake|This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
358121|NCT01099917|O1|Outcome|Maitake|This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
358122|NCT01099917|E1|Reported Event|Maitake|This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
358123|NCT01099774|B3|Baseline|Total|Total of all reporting groups
358124|NCT01099774|B2|Baseline|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
358125|NCT01099774|B1|Baseline|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
358126|NCT01099774|P2|Participant Flow|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
358127|NCT01099774|P1|Participant Flow|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
358128|NCT01099774|O2|Outcome|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
358129|NCT01099774|O1|Outcome|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
358130|NCT01099774|O2|Outcome|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
358135|NCT01099774|O1|Outcome|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
358136|NCT01099774|E2|Reported Event|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
358137|NCT01099774|E1|Reported Event|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
358138|NCT01099761|B5|Baseline|Total|Total of all reporting groups
358139|NCT01099761|B4|Baseline|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
358140|NCT01099761|B3|Baseline|ACE-031 ACE-03 2.5 mg/kg q4wk|ACE-031 2.5 mg/kg q4wk: ACE-031 2.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
358141|NCT01099761|B2|Baseline|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
358142|NCT01099761|B1|Baseline|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
358143|NCT01099761|P4|Participant Flow|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
358144|NCT01099761|P3|Participant Flow|ACE-031 ACE-03 2.5 mg/kg q4wk|ACE-031 2.5 mg/kg q4wk: ACE-031 2.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
358145|NCT01099761|P2|Participant Flow|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
358146|NCT01099761|P1|Participant Flow|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
358147|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
358148|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
358149|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
358150|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
358151|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
358152|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
358153|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
358154|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
358155|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
358156|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
358157|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
358158|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
358159|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
358160|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
358161|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
358162|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
358163|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
358164|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
358165|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
358166|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
358167|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
358168|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
358169|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
358170|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
358171|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
358172|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
358173|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
358174|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
358175|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
358176|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
358177|NCT01099761|E4|Reported Event|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
358178|NCT01099761|E3|Reported Event|ACE-031 ACE-03 2.5 mg/kg q4wk|ACE-031 2.5 mg/kg q4wk: ACE-031 2.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
358179|NCT01099761|E2|Reported Event|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
358180|NCT01099761|E1|Reported Event|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
358181|NCT01099709|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
358182|NCT01099709|P2|Participant Flow|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
358183|NCT01099709|P1|Participant Flow|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
358184|NCT01099709|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
358185|NCT01099709|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) fed, dosed administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
358186|NCT01099709|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
358187|NCT01099709|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
358188|NCT01099709|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
358189|NCT01099709|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
358190|NCT01099709|E2|Reported Event|Original OxyContin® (OXY) 10-mg Tablet (Fed)|Original OxyContin® (OXY) 10-mg tablet (fed) x 1 dose
358191|NCT01099709|E1|Reported Event|Reformulated OXY 10-mg Tablet (Fed)|Reformulated OXY 10-mg tablet (fed) x 1 dose
358192|NCT01099618|B4|Baseline|Total|Total of all reporting groups
358193|NCT01099618|B3|Baseline|Placebo|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg(n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~placebo: The study subject will receive a placebo tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
358194|NCT01099618|B2|Baseline|Sitagliptin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~Sitagliptin: The study subject will receive a sitagliptin 100mg once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
358195|NCT01099618|B1|Baseline|Metformin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~metformin: The study subject will receive metformin (MET) 1000 mg tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
358196|NCT01099618|P3|Participant Flow|Placebo|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg(n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~placebo: The study subject will receive a placebo tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
358197|NCT01099618|P2|Participant Flow|Sitagliptin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~Sitagliptin: The study subject will receive a sitagliptin 100mg once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
358198|NCT01099618|P1|Participant Flow|Metformin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~metformin: The study subject will receive metformin (MET) 1000 mg tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
358199|NCT01099618|O3|Outcome|Placebo|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg(n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~placebo: The study subject will receive a placebo tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
358831|NCT01097915|P1|Participant Flow|Super Tasters|Subjects highly sensitive to PROP
358200|NCT01099618|O2|Outcome|Sitagliptin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~Sitagliptin: The study subject will receive a sitagliptin 100mg once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
358201|NCT01099618|O1|Outcome|Metformin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~metformin: The study subject will receive metformin (MET) 1000 mg tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
358202|NCT01099618|E3|Reported Event|Placebo|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA and without ketoacidosis will be randomized to receive metformin (MET) 1000 mg(n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~placebo: The study subject will receive a placebo tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
358203|NCT01099618|E2|Reported Event|Sitagliptin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA and without ketoacidosis will be randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~Sitagliptin: The study subject will receive a sitagliptin 100mg once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
358204|NCT01099618|E1|Reported Event|Metformin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA and without ketoacidosis will be randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~metformin: The study subject will receive metformin (MET) 1000 mg tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
358205|NCT01099579|B4|Baseline|Total|Total of all reporting groups
358206|NCT01099579|B3|Baseline|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight of 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 20 to 40 mg received ATV, 200 mg, with RTV, 100 mg, and those who weighed at least 40 kg received ATV, 300 mg, with RTV, 100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
358207|NCT01099579|B2|Baseline|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to 20 kg received ATV, 150 mg, with RTV, 100 mg, and those who weighed 20 to 40 mg received ATV, 200 mg with RTV,100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
358208|NCT01099579|B1|Baseline|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
358218|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
358832|NCT01097915|O3|Outcome|Non-tasters|Subjects no sensitive to PROP
358209|NCT01099579|P3|Participant Flow|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
358210|NCT01099579|P2|Participant Flow|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
358211|NCT01099579|P1|Participant Flow|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Stage 1: Initial dose was determined by patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight of 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
358212|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
358213|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
358214|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
358215|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
358216|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
358217|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
358435|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
358436|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
358437|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
358219|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
358220|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
358221|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
358222|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
358223|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
358224|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
358225|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
358226|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
358227|NCT01099579|O2|Outcome|ARV-naive|ARV-naive participants had no prior exposure to ARV treatment. Patients exposed to ARVs in utero or intrapartum were also considered treatment naive.
358228|NCT01099579|O1|Outcome|ARV-experienced|ARV-experienced participants had previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.
358229|NCT01099579|O2|Outcome|ARV-naive|ARV-naive participants had no prior exposure to ARV treatment. Patients exposed to ARVs in utero or intrapartum were also considered treatment naive.
358230|NCT01099579|O1|Outcome|ARV-experienced|ARV-experienced participants had previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.
358231|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
358438|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
358439|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
358232|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
358233|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
358234|NCT01099579|O2|Outcome|ARV-naive|ARV-naive participants had no prior exposure to ARV treatment. Patients exposed to ARVs in utero or intrapartum were also considered treatment naive.
358235|NCT01099579|O1|Outcome|ARV-experienced|ARV-experienced participants had previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.
358236|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
358237|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
358238|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
358239|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
358240|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
358241|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
358242|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
358243|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
358440|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
358833|NCT01097915|O2|Outcome|Medium Tasters|Subjects sensitive to PROP
358244|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
358245|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
358246|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
358247|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
358248|NCT01099579|O2|Outcome|ARV-naive|ARV-naive participants had no prior exposure to ARV treatment. Patients exposed to ARVs in utero or intrapartum were also considered treatment naive.
358249|NCT01099579|O1|Outcome|ARV-experienced|ARV-experienced participants had previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.
358250|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
358251|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
358252|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
358253|NCT01099579|O2|Outcome|ARV-naive|ARV-naive participants had no prior exposure to ARV treatment. Patients exposed to ARVs in utero or intrapartum were also considered treatment naive.
358254|NCT01099579|O1|Outcome|ARV-experienced|ARV-experienced participants had previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.
358255|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
358256|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
358441|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
358442|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
358257|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
358258|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
358259|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
358260|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
358261|NCT01099579|E3|Reported Event|B/L Weight 15 to Less Than 25 kg|
358262|NCT01099579|E2|Reported Event|B/L Weight 10 to Less Than 15 kg|
358263|NCT01099579|E1|Reported Event|B/L Weight 5 to Less Than 10 kg|
358264|NCT01099475|B3|Baseline|Total|Total of all reporting groups
358265|NCT01099475|B2|Baseline|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion~Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
358266|NCT01099475|B1|Baseline|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.~Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
358267|NCT01099475|P2|Participant Flow|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion~Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
358268|NCT01099475|P1|Participant Flow|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.~Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
358269|NCT01099475|O2|Outcome|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion~Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
358270|NCT01099475|O1|Outcome|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.~Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
358271|NCT01099475|O2|Outcome|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion~Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
358272|NCT01099475|O1|Outcome|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.~Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
358273|NCT01099475|O2|Outcome|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion~Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
358443|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
358444|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
358274|NCT01099475|O1|Outcome|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.~Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
358275|NCT01099475|O2|Outcome|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion~Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
358276|NCT01099475|O1|Outcome|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.~Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
358277|NCT01099475|E2|Reported Event|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion~Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
358278|NCT01099475|E1|Reported Event|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.~Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
358279|NCT01099397|B1|Baseline|PEAR Sub-study Participants|All participants eligible for the PEAR study in Gainesville, FL, starting May 2009, were allowed to participate in the PEAR sub-study
358280|NCT01099397|P1|Participant Flow|PEAR Sub-study Participants|All participants eligible for the PEAR study in Gainesville, FL, starting May 2009, were allowed to participate in the PEAR sub-study; participants enrolled were evaluated at three time points as part of the PEAR protocol, at baseline, 9 weeks and 18 weeks; for each participant at each time point, a fasting glucose value and 2-hour oral glucose tolerance test value was collected and compared
358281|NCT01099397|O2|Outcome|Fasting Glucose|Fasting glucose collected
358282|NCT01099397|O1|Outcome|2-hour Glucose|Glucose collected after a 2 hour oral glucose tolerance test
358283|NCT01099397|E1|Reported Event|PEAR Sub-study Participants|All participants in the PEAR sub-study were evaluated by two methods at 3 time-points in the PEAR parent study
358284|NCT01099358|B1|Baseline|All Participants (All Participants (Group A, B, C and D)|"A:Cycle1:100mg/m² cisplatin(cs) I.V on week(w)1,day(d)1. 5-FU as a 96-hour(h) C.I. of 1000 mg/m²/d starting (st) on w 1,d 1-4.~400mg/m² cetuximab(ct) I.V on w 2,d 1.250mg/m² ct I.V on w 3,d 1.Cycle 2+100mg/m² cs I.V on w 1,d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1-4.250mg/m² ct I.V on w 1-3,d 1.~B:Cycle1:400mg/m² ct I.V on w 1,d 1.250mg/m² ct I.V on w 2&3,d 1.Cycle 2:100mg/m² cs I.V on w 1, d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1- 4.250mg/m² ct I.V on w 1-3,d 1.Cycle 3 +:100mg/m² cs I.V on w 1,d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1-4.~250mg/m² ct I.V on w 1-3,d 1. C:Cycle1:100mg/m² cs I.V on w 1, d 1. 5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1.400 mg/m² ct I.V on w 2,d 1.250mg/m² ct I.V on w 3&4,d 1.Cycle2-6:100mg/m² cs I.V on w 1,d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st w 1,d 1. 250mg/m² ct I.V w 1,2,&3,d 1.~D:Cycle1:400mg/m² ct I.V w 1,d 1.100mg/m² cs I.V w 1,d 1.Optional 5-FU as a 96-h C.I. of 1000mg/m²/d st w 1,d 1."
358285|NCT01099358|P4|Participant Flow|Cetuximab and Cisplatin (D)|"Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m²) cetuximab administered (admin) intravenously (I.V) on week 1, day 1.~100 mg/m² cisplatin administered I.V on week 1, day 1. Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/m²/day (d) administered starting on week 1, day 1.~After 1 cycle, participants may continue treatment as determined by the physician until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
358286|NCT01099358|P3|Participant Flow|Cetuximab and Cisplatin (C)|"Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1.~After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
358287|NCT01099358|P2|Participant Flow|Cetuximab on Cisplatin (B)|"Cycle 1:~400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1. After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
358445|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
358446|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
358447|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
360986|NCT01091116|O3|Outcome|High Dose|two doses
358288|NCT01099358|P1|Participant Flow|Cisplatin on Cetuximab (A)|"Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1. After 7 cycles, participants may then receive weekly Cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
358289|NCT01099358|O1|Outcome|Cetuximab (D)|"Cetuximab and Cisplatin (D)~Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m²) cetuximab administered (admin) intravenously (I.V) on week 1, day 1.~100 mg/m² cisplatin administered I.V on week 1, day 1. Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/m²/day (d) administered starting on week 1, day 1."
358290|NCT01099358|O2|Outcome|Cetuximab and Cisplatin (B and C)|"Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
358291|NCT01099358|O1|Outcome|Cetuximab (B and C)|"Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
358292|NCT01099358|O2|Outcome|Cetuximab and Cisplatin (A and C)|"Cisplatin on Cetuximab (A)~Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.~Cetuximab and Cisplatin (C)~Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
358293|NCT01099358|O1|Outcome|Cetuximab (A and C)|"Cisplatin on Cetuximab (A)~Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.~Cetuximab and Cisplatin (C)~Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
358294|NCT01099358|O2|Outcome|Cetuximab and Cisplatin (B and C)|"Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
358295|NCT01099358|O1|Outcome|Cetuximab (B and C)|"Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
358448|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
358449|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
358296|NCT01099358|O2|Outcome|Cetuximab and Cisplatin (A and C)|"Cisplatin on Cetuximab (A)~Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.~Cetuximab and Cisplatin (C)~Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
358297|NCT01099358|O1|Outcome|Cetuximab (A and C)|"Cisplatin on Cetuximab (A)~Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.~Cetuximab and Cisplatin (C)~Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
358298|NCT01099358|O2|Outcome|Cetuximab and Cisplatin (B and C)|"Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
358299|NCT01099358|O1|Outcome|Cetuximab (B and C)|"Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
358300|NCT01099358|O2|Outcome|Cetuximab and Cisplatin (A and C)|"Cisplatin on Cetuximab (A)~Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.~Cetuximab and Cisplatin (C)~Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
358301|NCT01099358|O1|Outcome|Cetuximab (A and C)|"Cisplatin on Cetuximab (A)~Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.~Cetuximab and Cisplatin (C)~Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
358302|NCT01099358|E4|Reported Event|Cetuximab and Cisplatin (D)|"Cetuximab and Cisplatin (D)~Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m²) cetuximab administered (admin) intravenously (I.V) on week 1, day 1.~100 mg/m² cisplatin administered I.V on week 1, day 1. Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/m²/day (d) administered starting on week 1, day 1.~After 1 cycle, participants may continue treatment as determined by the physician until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
358312|NCT01099267|O1|Outcome|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
358664|NCT01098162|O1|Outcome|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
358303|NCT01099358|E3|Reported Event|Cetuximab and Cisplatin (C)|"Cetuximab and Cisplatin (C)~Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1.~After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
358304|NCT01099358|E2|Reported Event|Cetuximab on Cisplatin (B)|"Cetuximab on Cisplatin (B)~Cycle 1:~400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
358305|NCT01099358|E1|Reported Event|Cisplatin on Cetuximab (A)|"Cisplatin on Cetuximab (A)~Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.~After 7 cycles, participants may then receive weekly Cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
358306|NCT01099267|B1|Baseline|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
358307|NCT01099267|P1|Participant Flow|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
358308|NCT01099267|O1|Outcome|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
358309|NCT01099267|O1|Outcome|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
358310|NCT01099267|O1|Outcome|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
358311|NCT01099267|O1|Outcome|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
358423|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
358424|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
358425|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
358834|NCT01097915|O1|Outcome|Super-tasters|Subjects highly sensitive to PROP
358313|NCT01099267|E1|Reported Event|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
358314|NCT01099215|B3|Baseline|Total|Total of all reporting groups
358315|NCT01099215|B2|Baseline|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
358316|NCT01099215|B1|Baseline|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
358317|NCT01099215|P2|Participant Flow|High Dose PVS-10200 (Cohort B)|High dose PVS-10200 (15×10^5 cells/cm lesion)
358318|NCT01099215|P1|Participant Flow|Low Dose PVS-10200 (Cohort A)|Low dose PVS-10200 (6×10^5 cells/cm lesion)
358319|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
358320|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
358321|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
358322|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
358323|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
358324|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
358325|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
358326|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
358327|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
358328|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
358329|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
358330|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
358331|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
358332|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
358333|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
358334|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
358335|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
358336|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
358337|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
358338|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
358339|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
358340|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
358341|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
358342|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
358343|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
358344|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
358345|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
358346|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
358347|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
358348|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
358349|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
358350|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
358351|NCT01099215|E2|Reported Event|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
358352|NCT01099215|E1|Reported Event|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
358353|NCT01099202|B3|Baseline|Total|Total of all reporting groups
358354|NCT01099202|B2|Baseline|No Procrit|No intervention.
358355|NCT01099202|B1|Baseline|Procrit|Starting dose 40,000 Units subcutaneously once a week with chemotherapy.
358356|NCT01099202|P2|Participant Flow|No Procrit|No intervention.
358357|NCT01099202|P1|Participant Flow|Procrit|Starting dose 40,000 Units subcutaneously once a week with chemotherapy.
358358|NCT01099202|O2|Outcome|No Procrit|No intervention.
358359|NCT01099202|O1|Outcome|Procrit|Starting dose 40,000 Units subcutaneously once a week with chemotherapy.
358360|NCT01099202|O2|Outcome|No Procrit|No intervention.
358361|NCT01099202|O1|Outcome|Procrit|Procrit starting dose 40,000 Units subcutaneously once a week with chemotherapy.
358362|NCT01099202|E2|Reported Event|No Procrit|No intervention.
358363|NCT01099202|E1|Reported Event|Procrit|Starting dose 40,000 Units subcutaneously once a week with chemotherapy.
358364|NCT01099111|B6|Baseline|Total|Total of all reporting groups
358365|NCT01099111|B5|Baseline|Control: Normal Subjects|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 22/12/2010, however, in view of insufficient DNA extraction of 6 subjects they have been replaced on 19/09/2012 with other 6 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
358426|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
358427|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
358428|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
358366|NCT01099111|B4|Baseline|Colo Rectal Cancer|"29 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 28/05/2012, and all have been identified as sufficient DNA extraction.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
358367|NCT01099111|B3|Baseline|Crohn's Disease|"46 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 27/05/2012, however, in view of insufficient DNA extraction of 2 subjects they have been replaced on 05/09/2012 with other 2 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
358368|NCT01099111|B2|Baseline|Ulcerative Colitis|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 05/06/2012, however, in view of insufficient DNA extraction of 3 subjects they have been replaced on 16/09/2012 with other 3 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
358369|NCT01099111|B1|Baseline|Irritable Bowel Syndrome|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 08/05/2011, however, in view of insufficient DNA extraction of 5 subjects they have been replaced (on 28/07/2012) with other 5 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
358370|NCT01099111|P5|Participant Flow|Control: Normal Subjects|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 22/12/2010, however, in view of insufficient DNA extraction of 6 subjects they have been replaced on 19/09/2012 with other 6 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
358371|NCT01099111|P4|Participant Flow|Colo Rectal Cancer|"29 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 28/05/2012, and all have been identified as sufficient DNA extraction.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
358372|NCT01099111|P3|Participant Flow|Crohn's Disease|"46 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 27/05/2012, however, in view of insufficient DNA extraction of 2 subjects they have been replaced on 05/09/2012 with other 2 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
358373|NCT01099111|P2|Participant Flow|Ulcerative Colitis|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 05/06/2012, however, in view of insufficient DNA extraction of 3 subjects they have been replaced on 16/09/2012 with other 3 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
358429|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
358430|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
358431|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
358835|NCT01097915|O3|Outcome|Non-tasters|Subjects no sensitive to PROP
358374|NCT01099111|P1|Participant Flow|Irritable Bowel Syndrome|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 08/05/2011, however, in view of insufficient DNA extraction of 5 subjects they have been replaced (on 28/07/2012) with other 5 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
358375|NCT01099111|O5|Outcome|Control: Normal Subjects|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 22/12/2010, however, in view of insufficient DNA extraction of 6 subjects they have been replaced on 19/09/2012 with other 6 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
358376|NCT01099111|O4|Outcome|Colo Rectal Cancer|"29 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 28/05/2012, and all have been identified as sufficient DNA extraction.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
358377|NCT01099111|O3|Outcome|Crohn's Disease|"46 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 27/05/2012, however, in view of insufficient DNA extraction of 2 subjects they have been replaced on 05/09/2012 with other 2 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
358378|NCT01099111|O2|Outcome|Ulcerative Colitis|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 05/06/2012, however, in view of insufficient DNA extraction of 3 subjects they have been replaced on 16/09/2012 with other 3 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
358379|NCT01099111|O1|Outcome|Irritable Bowel Syndrome|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 08/05/2011, however, in view of insufficient DNA extraction of 5 subjects they have been replaced (on 28/07/2012) with other 5 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
358380|NCT01099111|E5|Reported Event|Control: Normal Subjects|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 22/12/2010, however, in view of insufficient DNA extraction of 6 subjects they have been replaced on 19/09/2012 with other 6 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
358381|NCT01099111|E4|Reported Event|Colo Rectal Cancer|"29 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 28/05/2012, and all have been identified as sufficient DNA extraction.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
358432|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
358433|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
358434|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
358836|NCT01097915|O2|Outcome|Medium Tasters|Subjects sensitive to PROP
358382|NCT01099111|E3|Reported Event|Crohn's Disease|"46 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 27/05/2012, however, in view of insufficient DNA extraction of 2 subjects they have been replaced on 05/09/2012 with other 2 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
358383|NCT01099111|E2|Reported Event|Ulcerative Colitis|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 05/06/2012, however, in view of insufficient DNA extraction of 3 subjects they have been replaced on 16/09/2012 with other 3 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
358384|NCT01099111|E1|Reported Event|Irritable Bowel Syndrome|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 08/05/2011, however, in view of insufficient DNA extraction of 5 subjects they have been replaced (on 28/07/2012) with other 5 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
358385|NCT01098851|B3|Baseline|Total|Total of all reporting groups
358386|NCT01098851|B2|Baseline|Surgery Patients|Surgery patients at low risk for Obstructive Sleep Apnea
358387|NCT01098851|B1|Baseline|Obstructive Sleep Apnea|Surgery patients at high risk for Obstructive Sleep Apnea
358388|NCT01098851|P2|Participant Flow|Surgery Patients|Surgery patients at low risk for Obstructive Sleep Apnea
358389|NCT01098851|P1|Participant Flow|Obstructive Sleep Apnea|Surgery patients at high risk for Obstructive Sleep Apnea
358390|NCT01098851|O2|Outcome|Surgery Patients|Surgery patients at low risk for Obstructive Sleep Apnea
358391|NCT01098851|O1|Outcome|Obstructive Sleep Apnea|Surgery patients at high risk for Obstructive Sleep Apnea
358392|NCT01098851|O2|Outcome|Surgery Patients|Surgery patients at low risk for Obstructive Sleep Apnea
358393|NCT01098851|O1|Outcome|Obstructive Sleep Apnea|Surgery patients at high risk for Obstructive Sleep Apnea
358394|NCT01098851|E2|Reported Event|Surgery Patients|Surgery patients at low risk for Obstructive Sleep Apnea
358395|NCT01098851|E1|Reported Event|Obstructive Sleep Apnea|Surgery patients at high risk for Obstructive Sleep Apnea
358396|NCT01098812|B4|Baseline|Total|Total of all reporting groups
358397|NCT01098812|B3|Baseline|Higher Cylinder Toric IOL|Investigational toric IOLs with higher cylinder powers.
358398|NCT01098812|B2|Baseline|Toric IOL|Investigational Toric IOL
358399|NCT01098812|B1|Baseline|ZCB00|Approved Intraocular control lens
358400|NCT01098812|P3|Participant Flow|Higher Cylinder Toric IOL|Investigational toric IOLs with higher cylinder powers.
358401|NCT01098812|P2|Participant Flow|Toric IOL|Investigational Toric IOL
358402|NCT01098812|P1|Participant Flow|ZCB00|Approved Intraocular control lens
358403|NCT01098812|O3|Outcome|Higher Cylinder Toric IOL|Investigational Toric IOLs with higher cylinder powers.
358404|NCT01098812|O2|Outcome|Toric IOL|Investigational Toric IOL
358405|NCT01098812|O1|Outcome|Control IOL|Approved Intraocular control lens
358406|NCT01098812|O3|Outcome|Higher Cylinder Toric IOL|Investigational Toric IOLs with higher cylinder powers.
358407|NCT01098812|O2|Outcome|Toric IOL|Investigational Toric IOL
358408|NCT01098812|O1|Outcome|Control IOL|Approved Intraocular control lens
358409|NCT01098812|E2|Reported Event|All Toric IOLs|Investigational Toric IOLs including high cylinder powers
358410|NCT01098812|E1|Reported Event|ZCB00|Approved Intraocular control lens
358411|NCT01098747|B5|Baseline|Total|Total of all reporting groups
358412|NCT01098747|B4|Baseline|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen [Motrin ibuprofen (IB)] 200 mg tablets (total dose of 400 mg ibuprofen).
358413|NCT01098747|B3|Baseline|Ibuprofen (Advil)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen).
358414|NCT01098747|B2|Baseline|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
358415|NCT01098747|B1|Baseline|Placebo|Single oral dose of 2 placebo tablets.
358416|NCT01098747|P4|Participant Flow|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen [Motrin ibuprofen (IB)] 200 mg tablets (total dose of 400 mg ibuprofen).
358417|NCT01098747|P3|Participant Flow|Ibuprofen (Advil)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen).
358418|NCT01098747|P2|Participant Flow|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
358419|NCT01098747|P1|Participant Flow|Placebo|Single oral dose of 2 placebo tablets.
358420|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
358421|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
358422|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
358665|NCT01098162|O1|Outcome|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
358450|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
358451|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
358452|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
358453|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
358454|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
358455|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
358456|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
358457|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
358458|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
358459|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
358460|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
358461|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
358462|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
358463|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
358464|NCT01098747|E4|Reported Event|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen [Motrin ibuprofen (IB)] 200 mg tablets (total dose of 400 mg ibuprofen).
358465|NCT01098747|E3|Reported Event|Ibuprofen (Advil)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen).
358466|NCT01098747|E2|Reported Event|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
358467|NCT01098747|E1|Reported Event|Placebo|Single oral dose of 2 placebo tablets.
358468|NCT01098578|B1|Baseline|Floseal|"Received Floseal treatment for posterior epistaxis.~Floseal : Received Floseal as treatment for posterior epistaxis."
358469|NCT01098578|P1|Participant Flow|Floseal.|Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion.
358470|NCT01098578|O2|Outcome|Endoscopic Surgery|The calculated minimal institutional cost if all the study patients had been treated with endoscopic surgery for posterior epistaxis
358471|NCT01098578|O1|Outcome|FLOSEAL|Institutional cost of treating all study patients with Floseal for posterior epistaxis
358472|NCT01098578|O1|Outcome|Floseal|Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion
358473|NCT01098578|O1|Outcome|Floseal|Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion
358474|NCT01098578|E1|Reported Event|Floseal|Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion
358475|NCT01098539|B3|Baseline|Total|Total of all reporting groups
358476|NCT01098539|B2|Baseline|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358477|NCT01098539|B1|Baseline|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358478|NCT01098539|P2|Participant Flow|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358479|NCT01098539|P1|Participant Flow|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358480|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358481|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358482|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358483|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358484|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358485|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358486|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358487|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358488|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358489|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358490|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358543|NCT01098461|B3|Baseline|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358666|NCT01098162|O1|Outcome|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
358491|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358492|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358493|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358494|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358495|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358496|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358497|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358498|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358499|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358500|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358544|NCT01098461|B2|Baseline|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358837|NCT01097915|O1|Outcome|Super-tasters|Subjects highly sensitive to PROP
358501|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358502|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358503|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358504|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358505|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358506|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358507|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358508|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358509|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358510|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358545|NCT01098461|B1|Baseline|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358667|NCT01098162|O1|Outcome|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
358511|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358512|NCT01098539|E2|Reported Event|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358513|NCT01098539|E1|Reported Event|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
358514|NCT01098500|B1|Baseline|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
358515|NCT01098500|P1|Participant Flow|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
358516|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
358517|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
358518|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
358519|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
358606|NCT01098305|B3|Baseline|Total|Total of all reporting groups
358520|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
358521|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
358522|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
358523|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
358524|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
358525|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
358526|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
358527|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
358621|NCT01098253|P1|Participant Flow|Integrated Care Intervention|We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.
358528|NCT01098500|E1|Reported Event|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
358529|NCT01098487|B1|Baseline|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
358530|NCT01098487|P1|Participant Flow|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
358531|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
358532|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
358533|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
358534|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
358535|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
358536|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
358537|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
358538|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
358539|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
358540|NCT01098487|E1|Reported Event|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
358541|NCT01098461|B5|Baseline|Total|Total of all reporting groups
358542|NCT01098461|B4|Baseline|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358622|NCT01098253|O2|Outcome|Usual Care|
358546|NCT01098461|P4|Participant Flow|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358547|NCT01098461|P3|Participant Flow|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358548|NCT01098461|P2|Participant Flow|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358549|NCT01098461|P1|Participant Flow|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358550|NCT01098461|O1|Outcome|Albiglutide 15/30 mg Weekly or 30 mg Every Other Week|Participants received albiglutide 15 mg weekly, 30 mg weekly, or 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358551|NCT01098461|O1|Outcome|Albiglutide 15/30 mg Weekly or 30 mg Every Other Week|Participants received albiglutide 15 mg weekly, 30 mg weekly, or 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358552|NCT01098461|O1|Outcome|Albiglutide 15/30 mg Weekly or 30 mg Every Other Week|Participants received albiglutide 15 mg weekly, 30 mg weekly, or 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358553|NCT01098461|O1|Outcome|Albiglutide 15/30 mg Weekly or 30 mg Every Other Week|Participants received albiglutide 15 mg weekly, 30 mg weekly, or 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358554|NCT01098461|O4|Outcome|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358555|NCT01098461|O3|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358556|NCT01098461|O2|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358557|NCT01098461|O1|Outcome|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358558|NCT01098461|O4|Outcome|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358559|NCT01098461|O3|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358560|NCT01098461|O2|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358561|NCT01098461|O1|Outcome|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358562|NCT01098461|O4|Outcome|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358563|NCT01098461|O3|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358564|NCT01098461|O2|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358565|NCT01098461|O1|Outcome|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358662|NCT01098162|O1|Outcome|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
358566|NCT01098461|O4|Outcome|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358567|NCT01098461|O3|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358568|NCT01098461|O2|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358569|NCT01098461|O1|Outcome|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358570|NCT01098461|O4|Outcome|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358571|NCT01098461|O3|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358572|NCT01098461|O2|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358573|NCT01098461|O1|Outcome|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358574|NCT01098461|E4|Reported Event|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358575|NCT01098461|E3|Reported Event|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358576|NCT01098461|E2|Reported Event|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358577|NCT01098461|E1|Reported Event|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
358578|NCT01098318|B4|Baseline|Total|Total of all reporting groups
358579|NCT01098318|B3|Baseline|Sugar Pill|"Lactose monohydrate~Lactose monohydrate: 1-4 capsules daily"
358580|NCT01098318|B2|Baseline|Sertraline|"Conventional anti-depressant~Sertraline: 50-200 mg daily"
358581|NCT01098318|B1|Baseline|Rhodiola Rosea|"Herbal extract~Herbal extract: 340-1,360 mg daily"
358582|NCT01098318|P3|Participant Flow|Sugar Pill|"Lactose monohydrate~Lactose monohydrate: 1-4 capsules daily"
358583|NCT01098318|P2|Participant Flow|Sertraline|"Conventional anti-depressant~Sertraline: 50-200 mg daily"
358584|NCT01098318|P1|Participant Flow|Rhodiola Rosea|"Herbal extract~Herbal extract: 340-1,360 mg daily"
358585|NCT01098318|O3|Outcome|Sugar Pill|"Lactose monohydrate~Lactose monohydrate: 1-4 capsules daily"
358586|NCT01098318|O2|Outcome|Sertraline|"Conventional anti-depressant~Sertraline: 50-200 mg daily"
358587|NCT01098318|O1|Outcome|Rhodiola Rosea|"Herbal extract~Herbal extract: 340-1,360 mg daily"
358588|NCT01098318|O3|Outcome|Sugar Pill|"Lactose monohydrate~Lactose monohydrate: 1-4 capsules daily"
358589|NCT01098318|O2|Outcome|Sertraline|"Conventional anti-depressant~Sertraline: 50-200 mg daily"
358590|NCT01098318|O1|Outcome|Rhodiola Rosea|"Herbal extract~Herbal extract: 340-1,360 mg daily"
358591|NCT01098318|O3|Outcome|Sugar Pill|"Lactose monohydrate~Lactose monohydrate: 1-4 capsules daily"
358592|NCT01098318|O2|Outcome|Sertraline|"Conventional anti-depressant~Sertraline: 50-200 mg daily"
358593|NCT01098318|O1|Outcome|Rhodiola Rosea|"Herbal extract~Herbal extract: 340-1,360 mg daily"
358594|NCT01098318|O3|Outcome|Sugar Pill|"Lactose monohydrate~Lactose monohydrate: 1-4 capsules daily"
358595|NCT01098318|O2|Outcome|Sertraline|"Conventional anti-depressant~Sertraline: 50-200 mg daily"
358596|NCT01098318|O1|Outcome|Rhodiola Rosea|"Herbal extract~Herbal extract: 340-1,360 mg daily"
358597|NCT01098318|O3|Outcome|Sugar Pill|"Lactose monohydrate~Lactose monohydrate: 1-4 capsules daily"
358598|NCT01098318|O2|Outcome|Sertraline|"Conventional anti-depressant~Sertraline: 50-200 mg daily"
358599|NCT01098318|O1|Outcome|Rhodiola Rosea|"Herbal extract~Herbal extract: 340-1,360 mg daily"
358600|NCT01098318|O3|Outcome|Sugar Pill|"Lactose monohydrate~Lactose monohydrate: 1-4 capsules daily"
358601|NCT01098318|O2|Outcome|Sertraline|"Conventional anti-depressant~Sertraline: 50-200 mg daily"
358602|NCT01098318|O1|Outcome|Rhodiola Rosea|"Herbal extract~Herbal extract: 340-1,360 mg daily"
358603|NCT01098318|E3|Reported Event|Sugar Pill|"Lactose monohydrate~Lactose monohydrate: 1-4 capsules daily"
358604|NCT01098318|E2|Reported Event|Sertraline|"Conventional anti-depressant~Sertraline: 50-200 mg daily"
358605|NCT01098318|E1|Reported Event|Rhodiola Rosea|"Herbal extract~Herbal extract: 340-1,360 mg daily"
358607|NCT01098305|B2|Baseline|Placebo|Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.
358608|NCT01098305|B1|Baseline|Varenicline|"Varenicline: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).~Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field."
358609|NCT01098305|P2|Participant Flow|Placebo|Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.
358610|NCT01098305|P1|Participant Flow|Varenicline|"Varenicline: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).~Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field."
358611|NCT01098305|O2|Outcome|Placebo|Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.
358612|NCT01098305|O1|Outcome|Varenicline|"Varenicline: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).~Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field."
358613|NCT01098305|O2|Outcome|Placebo|Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.
358614|NCT01098305|O1|Outcome|Varenicline|"Varenicline: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).~Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field."
358615|NCT01098305|E2|Reported Event|Placebo|Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.
358616|NCT01098305|E1|Reported Event|Varenicline|"Varenicline: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).~Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field."
358617|NCT01098253|B3|Baseline|Total|Total of all reporting groups
358618|NCT01098253|B2|Baseline|Usual Care|
358619|NCT01098253|B1|Baseline|Integrated Care Intervention|We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.
358620|NCT01098253|P2|Participant Flow|Usual Care|
358838|NCT01097915|O3|Outcome|Non Tasters|Subjects no sensitive to PROP
358623|NCT01098253|O1|Outcome|Integrated Care Intervention|We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.
358624|NCT01098253|O2|Outcome|Usual Care|
358625|NCT01098253|O1|Outcome|Integrated Care Intervention|We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.
358626|NCT01098253|E2|Reported Event|Usual Care|
358627|NCT01098253|E1|Reported Event|Integrated Care Intervention|We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.
358628|NCT01098240|B1|Baseline|Open-Label ADT|Participants treated with 1 of 5 allowed antidepressant agents in accordance with current product labeling, targeting the following doses by the end of week 2: escitalopram (Lexapro) (10-20 mg/d), citalopram (Celexa) (20-40 mg/d), fluoxetine (Prozac, Sarafem) (20-60 mg/d), paroxetine CR (Paxil CR) (37.5-62.5 mg/d), sertraline (Zoloft) (100-200 mg/d), for up to 8 weeks in open-label phase.
358629|NCT01098240|P3|Participant Flow|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358630|NCT01098240|P2|Participant Flow|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg every evening (QPM) for 3 days, then 1 mg twice daily (BID) for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358631|NCT01098240|P1|Participant Flow|Open-Label Antidepressant Treatment (ADT)|Participants treated with 1 of 5 allowed antidepressant agents in accordance with current product labeling, targeting the following doses by the end of week 2: escitalopram (Lexapro) (10-20 milligram/day [mg/d]), citalopram (Celexa) (20-40 mg/d), fluoxetine (Prozac, Sarafem) (20-60 mg/d), paroxetine controlled-release (CR) (Paxil CR) (37.5-62.5 mg/d), sertraline (Zoloft) (100-200 mg/d), for up to 8 weeks in open-label phase.
358632|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358633|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358634|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358635|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358636|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358637|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358638|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358639|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358640|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358641|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358642|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358663|NCT01098162|O1|Outcome|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
358643|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358644|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358645|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358646|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358647|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358648|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358649|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358650|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358651|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358652|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358653|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358654|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358655|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358656|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358657|NCT01098240|E3|Reported Event|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358658|NCT01098240|E2|Reported Event|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
358659|NCT01098240|E1|Reported Event|Open-Label ADT|Participants treated with 1 of 5 allowed antidepressant agents in accordance with current product labeling, targeting the following doses by the end of week 2: escitalopram (Lexapro) (10-20 mg/d), citalopram (Celexa) (20-40 mg/d), fluoxetine (Prozac, Sarafem) (20-60 mg/d), paroxetine CR (Paxil CR) (37.5-62.5 mg/d), sertraline (Zoloft) (100-200 mg/d), for up to 8 weeks in open-label phase.
358660|NCT01098162|B1|Baseline|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
358661|NCT01098162|P1|Participant Flow|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
358714|NCT01098110|E1|Reported Event|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
358668|NCT01098162|E1|Reported Event|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
358669|NCT01098110|B4|Baseline|Total|Total of all reporting groups
358670|NCT01098110|B3|Baseline|Placebo BID|Participants received matching placebo BID for 6 weeks.
358671|NCT01098110|B2|Baseline|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
358672|NCT01098110|B1|Baseline|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
358673|NCT01098110|P3|Participant Flow|Placebo BID|Participants received matching placebo BID for 6 weeks.
358674|NCT01098110|P2|Participant Flow|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
358675|NCT01098110|P1|Participant Flow|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet twice daily (BID) for 6 weeks.
358676|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
358677|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
358678|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
358679|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
358680|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
358681|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
358682|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
358683|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
358684|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
358685|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
358686|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
358687|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
358688|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
358689|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
358690|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
358691|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
358692|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
358693|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
358694|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
358695|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
358696|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
358697|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
358698|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
358699|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
358700|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
358701|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
358702|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
358703|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
358704|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
358705|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
358706|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
358707|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
358708|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
358709|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
358710|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
358711|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
358712|NCT01098110|E3|Reported Event|Placebo BID|Participants received matching placebo BID for 6 weeks.
358713|NCT01098110|E2|Reported Event|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
358839|NCT01097915|O2|Outcome|Medium Tasters|Subjects sensitive to PROP
358715|NCT01098097|B1|Baseline|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
358716|NCT01098097|P1|Participant Flow|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
358717|NCT01098097|O1|Outcome|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
358718|NCT01098097|O1|Outcome|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
358719|NCT01098097|O1|Outcome|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
358720|NCT01098097|O1|Outcome|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
358721|NCT01098097|O1|Outcome|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
358722|NCT01098097|O1|Outcome|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
358723|NCT01098097|E1|Reported Event|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
358724|NCT01098071|B1|Baseline|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
358725|NCT01098071|P1|Participant Flow|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
358726|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
358727|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
358728|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
358729|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
358730|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
358731|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
358732|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
358733|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
358734|NCT01098071|E1|Reported Event|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
358735|NCT01098032|B3|Baseline|Total|Total of all reporting groups
358736|NCT01098032|B2|Baseline|RenalGuard System Group|Prophylactic controlled hydration with saline (0.9%) plus N-acetylcystein (NAC; 6 g in total). In the RenalGuard group, an initial bolus (priming) of 250 ml will be administered. In case of left ventricular dysfunction (ejection fraction ≤30%) and/or unstable hemodynamic conditions the bolus will be reduced to 150 ml. Following the initial bolus, furosemide (0.25 mg/kg) will be administered in order to achieve the optimal urine flow (≥300 ml/h). The hydration will be continued throughout the duration of the procedure and will last 4 hours following the procedure. Additional doses of furosemide are allowed in case of decrease of urine flow <300 ml/h.
358737|NCT01098032|B1|Baseline|Systemic Alone Therapy Group|Systemic alone therapy grou will be treated by intravenous sodium bicarbonate plus NAC administration. Patients allocated to the Systemic alone therapy group will receive 154 mEq/l of sodium bicarbonate in dextrose and H2O, according to the protocol reported by Merten et al. (9) The initial intravenous bolus was 3 ml/kg per hour for 1 hour immediately before contrast injection. Following this, patients will receive the same fluid at a rate of 1 ml/kg per hour during contrast exposure and for 6 hours after the procedure. All patients will receive NAC (Fluimucil, Zambon Group SpA, Milan, Italy) orally at a dose of 1200 mg twice daily on the day before and on the day of administration of the contrast agent (total of 2 days. Additional NAC dose (1.2 g) will be administered i.v. during the procedure.
358738|NCT01098032|P2|Participant Flow|RenalGuard System Group|Prophylactic controlled hydration with saline (0.9%) plus N-acetylcystein (NAC; 6 g in total). In the RenalGuard group, an initial bolus (priming) of 250 ml will be administered. In case of left ventricular dysfunction (ejection fraction ≤30%) and/or unstable hemodynamic conditions the bolus will be reduced to 150 ml. Following the initial bolus, furosemide (0.25 mg/kg) will be administered in order to achieve the optimal urine flow (≥300 ml/h). The hydration will be continued throughout the duration of the procedure and will last 4 hours following the procedure. Additional doses of furosemide are allowed in case of decrease of urine flow <300 ml/h.
358739|NCT01098032|P1|Participant Flow|Systemic Alone Therapy Group|Systemic alone therapy grou will be treated by intravenous sodium bicarbonate plus NAC administration. Patients allocated to the Systemic alone therapy group will receive 154 mEq/l of sodium bicarbonate in dextrose and H2O, according to the protocol reported by Merten et al. (9) The initial intravenous bolus was 3 ml/kg per hour for 1 hour immediately before contrast injection. Following this, patients will receive the same fluid at a rate of 1 ml/kg per hour during contrast exposure and for 6 hours after the procedure. All patients will receive NAC (Fluimucil, Zambon Group SpA, Milan, Italy) orally at a dose of 1200 mg twice daily on the day before and on the day of administration of the contrast agent (total of 2 days. Additional NAC dose (1.2 g) will be administered i.v. during the procedure.
358829|NCT01097915|P3|Participant Flow|Non Tasters|Subjects no sensitive to PROP
358830|NCT01097915|P2|Participant Flow|Medium Tasters|Subjects sensitive to PROP
358740|NCT01098032|O2|Outcome|RenalGuard System Group|Prophylactic controlled hydration with saline (0.9%) plus N-acetylcystein (NAC; 6 g in total). In the RenalGuard group, an initial bolus (priming) of 250 ml will be administered. In case of left ventricular dysfunction (ejection fraction ≤30%) and/or unstable hemodynamic conditions the bolus will be reduced to 150 ml. Following the initial bolus, furosemide (0.25 mg/kg) will be administered in order to achieve the optimal urine flow (≥300 ml/h). The hydration will be continued throughout the duration of the procedure and will last 4 hours following the procedure. Additional doses of furosemide are allowed in case of decrease of urine flow <300 ml/h.
358741|NCT01098032|O1|Outcome|Systemic Alone Therapy Group|Systemic alone therapy grou will be treated by intravenous sodium bicarbonate plus NAC administration. Patients allocated to the Systemic alone therapy group will receive 154 mEq/l of sodium bicarbonate in dextrose and H2O, according to the protocol reported by Merten et al. (9) The initial intravenous bolus was 3 ml/kg per hour for 1 hour immediately before contrast injection. Following this, patients will receive the same fluid at a rate of 1 ml/kg per hour during contrast exposure and for 6 hours after the procedure. All patients will receive NAC (Fluimucil, Zambon Group SpA, Milan, Italy) orally at a dose of 1200 mg twice daily on the day before and on the day of administration of the contrast agent (total of 2 days. Additional NAC dose (1.2 g) will be administered i.v. during the procedure.
358742|NCT01098032|E2|Reported Event|Systemic Alone Therapy Group|Systemic alone therapy group was treated by intravenous sodium bicarbonate plus NAC administration.
358743|NCT01098032|E1|Reported Event|RenalGuard System Group|Prophylactic controlled hydration with saline (0.9%) plus N-acetylcystein (NAC; 6 g in total). In the RenalGuard group, an initial bolus (priming) of 250 ml will be administered. In case of left ventricular dysfunction (ejection fraction ≤30%) and/or unstable hemodynamic conditions the bolus will be reduced to 150 ml. Following the initial bolus, furosemide (0.25 mg/kg) will be administered in order to achieve the optimal urine flow (≥300 ml/h). The hydration will be continued throughout the duration of the procedure and will last 4 hours following the procedure.
358744|NCT01098006|B5|Baseline|Total|Total of all reporting groups
358745|NCT01098006|B4|Baseline|Group 4|HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
358746|NCT01098006|B3|Baseline|Group 3|Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
358747|NCT01098006|B2|Baseline|Group 2|HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
358748|NCT01098006|B1|Baseline|Group 1|Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
358749|NCT01098006|P4|Participant Flow|Group 4|HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
358750|NCT01098006|P3|Participant Flow|Group 3|Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
358751|NCT01098006|P2|Participant Flow|Group 2|HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
358752|NCT01098006|P1|Participant Flow|Group 1|Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
358753|NCT01098006|O4|Outcome|Group 4|HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
358754|NCT01098006|O3|Outcome|Group 3|Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
358755|NCT01098006|O2|Outcome|Group 2|HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
358756|NCT01098006|O1|Outcome|Group 1|Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
358757|NCT01098006|O4|Outcome|Group 4|HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
358758|NCT01098006|O3|Outcome|Group 3|Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
358759|NCT01098006|O2|Outcome|Group 2|HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
358760|NCT01098006|O1|Outcome|Group 1|Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
358761|NCT01098006|O4|Outcome|Group 4|HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
358762|NCT01098006|O3|Outcome|Group 3|Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
358763|NCT01098006|O2|Outcome|Group 2|HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
358764|NCT01098006|O1|Outcome|Group 1|Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
358765|NCT01098006|O4|Outcome|Group 4|HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
358766|NCT01098006|O3|Outcome|Group 3|Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
358767|NCT01098006|O2|Outcome|Group 2|HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
358768|NCT01098006|O1|Outcome|Group 1|Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
358769|NCT01098006|O4|Outcome|Group 4|HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
358770|NCT01098006|O3|Outcome|Group 3|Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
358771|NCT01098006|O2|Outcome|Group 2|HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
358772|NCT01098006|O1|Outcome|Group 1|Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
358773|NCT01098006|O4|Outcome|Group 4|HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
358774|NCT01098006|O3|Outcome|Group 3|Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
358775|NCT01098006|O2|Outcome|Group 2|HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
358776|NCT01098006|O1|Outcome|Group 1|Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
358777|NCT01098006|O4|Outcome|Group 4|HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
358778|NCT01098006|O3|Outcome|Group 3|Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
358779|NCT01098006|O2|Outcome|Group 2|HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
358780|NCT01098006|O1|Outcome|Group 1|Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
358781|NCT01098006|O4|Outcome|Group 4|HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
360987|NCT01091116|O2|Outcome|Mid Dose|two doses
358782|NCT01098006|O3|Outcome|Group 3|Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
358783|NCT01098006|O2|Outcome|Group 2|HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
358784|NCT01098006|O1|Outcome|Group 1|Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
358785|NCT01098006|O4|Outcome|Group 4|HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
358786|NCT01098006|O3|Outcome|Group 3|Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
358787|NCT01098006|O2|Outcome|Group 2|HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
358788|NCT01098006|O1|Outcome|Group 1|Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
358789|NCT01098006|O4|Outcome|Group 4|HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
358790|NCT01098006|O3|Outcome|Group 3|Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
358791|NCT01098006|O2|Outcome|Group 2|HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
358792|NCT01098006|O1|Outcome|Group 1|Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
358793|NCT01098006|O4|Outcome|Group 4|HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
358794|NCT01098006|O3|Outcome|Group 3|Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
358795|NCT01098006|O2|Outcome|Group 2|HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
358796|NCT01098006|O1|Outcome|Group 1|Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
358797|NCT01098006|O4|Outcome|Group 4|HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
358798|NCT01098006|O3|Outcome|Group 3|Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
358799|NCT01098006|O2|Outcome|Group 2|HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
358800|NCT01098006|O1|Outcome|Group 1|Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
358801|NCT01098006|O4|Outcome|Group 4|HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
358802|NCT01098006|O3|Outcome|Group 3|Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
358803|NCT01098006|O2|Outcome|Group 2|HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
360988|NCT01091116|O1|Outcome|Low Dose|two doses
358804|NCT01098006|O1|Outcome|Group 1|Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
358805|NCT01098006|O4|Outcome|Group 4|HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
358806|NCT01098006|O3|Outcome|Group 3|Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
358807|NCT01098006|O2|Outcome|Group 2|HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
358808|NCT01098006|O1|Outcome|Group 1|Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
358809|NCT01098006|O4|Outcome|Group 4|HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
358810|NCT01098006|O3|Outcome|Group 3|Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
358811|NCT01098006|O2|Outcome|Group 2|HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
358812|NCT01098006|O1|Outcome|Group 1|Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
358813|NCT01098006|O4|Outcome|Group 4|HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
358814|NCT01098006|O3|Outcome|Group 3|Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
358815|NCT01098006|O2|Outcome|Group 2|HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
358816|NCT01098006|O1|Outcome|Group 1|Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
358817|NCT01098006|O4|Outcome|Group 4|HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
358818|NCT01098006|O3|Outcome|Group 3|Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
358819|NCT01098006|O2|Outcome|Group 2|HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
358820|NCT01098006|O1|Outcome|Group 1|Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
358821|NCT01098006|E4|Reported Event|Group 4|HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
358822|NCT01098006|E3|Reported Event|Group 3|Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
358823|NCT01098006|E2|Reported Event|Group 2|HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
358824|NCT01098006|E1|Reported Event|Group 1|Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
358825|NCT01097915|B4|Baseline|Total|Total of all reporting groups
358826|NCT01097915|B3|Baseline|Non Tasters|Subjects no sensitive to PROP
358827|NCT01097915|B2|Baseline|Medium Tasters|Subjects sensitive to PROP
358828|NCT01097915|B1|Baseline|Super Tasters|Subjects highly sensitive to PROP
358840|NCT01097915|O1|Outcome|Super Tasters|Subjects highly sensitive to PROP
358841|NCT01097915|E3|Reported Event|Non Tasters|Subjects no sensitive to PROP
358842|NCT01097915|E2|Reported Event|Medium Tasters|Subjects sensitive to PROP
358843|NCT01097915|E1|Reported Event|Super Tasters|Subjects highly sensitive to PROP
358844|NCT01097863|B4|Baseline|Total|Total of all reporting groups
358845|NCT01097863|B3|Baseline|Nelfilcon A, Inversion Indicator|nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
358846|NCT01097863|B2|Baseline|Nelfilcon A, No Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
358847|NCT01097863|B1|Baseline|Nelfilcon A, Modified Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
358848|NCT01097863|P3|Participant Flow|Nelfilcon A, Inversion Indicator|nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
358849|NCT01097863|P2|Participant Flow|Nelfilcon A, No Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
358850|NCT01097863|P1|Participant Flow|Nelfilcon A, Modified Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
358851|NCT01097863|O3|Outcome|Nelfilcon A, Inversion Indicator|nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
358852|NCT01097863|O2|Outcome|Nelfilcon A, No Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
358853|NCT01097863|O1|Outcome|Nelfilcon A, Modified Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
358854|NCT01097863|E3|Reported Event|Nelfilcon A, Inversion Indicator|nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
358855|NCT01097863|E2|Reported Event|Nelfilcon A, No Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
358856|NCT01097863|E1|Reported Event|Nelfilcon A, Modified Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
358857|NCT01097785|B3|Baseline|Total|Total of all reporting groups
358858|NCT01097785|B2|Baseline|Placebo, Then Simvastatin|Cycle 1: Participants received Placebo capsule 1 pill every day for 30 days. Cycle 2: Two week washout period. Cycle 3: Simvastatin 40mg once every day for 30 days.
358859|NCT01097785|B1|Baseline|Simvastatin, Then Placebo|Cycle 1: Participants received 40 mg Simvastatin 1 pill every day for 30 days. Cycle 2: Two week washout period. Cycle 3: Placebo pill once every day for 30 days.
358860|NCT01097785|P2|Participant Flow|Placebo, Then Simvastatin|Cycle 1: Participants received Placebo capsule 1 pill every day for 30 days. Cycle 2: Two week washout period. Cycle 3: Simvastatin 40mg once every day for 30 days.
358861|NCT01097785|P1|Participant Flow|Simvastatin, Then Placebo|Cycle 1: Participants received 40 mg Simvastatin 1 pill every day for 30 days. Cycle 2: Two week washout period. Cycle 3: Placebo pill once every day for 30 days.
358862|NCT01097785|O2|Outcome|Placebo|"Placebo cap 1 pill every day for 30 days~Placebo: 1 capsule daily for 30 days"
358863|NCT01097785|O1|Outcome|Simvastatin|40 mg Simvastatin 1 pill every day for 30 days
358864|NCT01097785|O2|Outcome|Placebo|Placebo cap 1 pill every day for 30 days
358865|NCT01097785|O1|Outcome|Simvastatin|40 mg Simvastatin 1 pill every day for 30 days
358866|NCT01097785|E2|Reported Event|Placebo|"Placebo cap 1 pill every day for 30 days~Placebo: 1 capsule daily for 30 days"
358867|NCT01097785|E1|Reported Event|Simvastatin|"40 mg Simvastatin 1 pill every day for 30 days~Simvastatin: 40 mg, P.O.,daily for 30 days"
358868|NCT01097694|B3|Baseline|Total|Total of all reporting groups
358869|NCT01097694|B2|Baseline|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358870|NCT01097694|B1|Baseline|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358871|NCT01097694|P2|Participant Flow|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358872|NCT01097694|P1|Participant Flow|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358873|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358874|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358875|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358876|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358877|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358878|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358879|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358880|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
360989|NCT01091116|E5|Reported Event|Placebo|two doses
358881|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358882|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358883|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358884|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358885|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358886|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358887|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358888|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358889|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358890|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358891|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358892|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358893|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358894|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358895|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358896|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358897|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358898|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358899|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358900|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358901|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358902|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358903|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358904|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358905|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358906|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358907|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358908|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358909|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358910|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358911|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358912|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358913|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
359099|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
358914|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358915|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358916|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358917|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358918|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358919|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358920|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358921|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358922|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358923|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358924|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358925|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358926|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358927|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358928|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358929|NCT01097694|E2|Reported Event|Placebo|"Group on Placebo treatment~Placebo: Placebo"
358930|NCT01097694|E1|Reported Event|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
358931|NCT01097668|B3|Baseline|Total|Total of all reporting groups
358932|NCT01097668|B2|Baseline|Subcutaneous Injection|Injections of ATX-MS-1467 given by the subcutaneous route
358933|NCT01097668|B1|Baseline|Intradermal Injection|Injections of ATX-MS-1467 given by the intradermal route
358934|NCT01097668|P2|Participant Flow|Subcutaneous Injection|Upward titration over 4 dose levels (injections of 25, 50, 100 and 400 ug) of ATX MS 1467 followed by injections of 800 ug injected on 5 occasions. All injections were administered at intervals of 14±3 days.
358935|NCT01097668|P1|Participant Flow|Intradermal Injection|Upward titration over 4 dose levels (injections of 25, 50, 100 and 400 ug) of ATX MS 1467 followed by injections of 800 ug injected on 5 occasions. All injections were administered at intervals of 14±3 days.
358936|NCT01097668|O2|Outcome|Subcutaneous Injection|Injections of ATX-MS-1467 administered by subcutaneous route
358937|NCT01097668|O1|Outcome|Intradermal|Injections of ATX-MS-1467 administered by intradermal route
358938|NCT01097668|O2|Outcome|Subcutaneous Injection|Injections of ATX-MS-1467 administered by the subcutaneous route
358939|NCT01097668|O1|Outcome|Intradermal Injection|Injections of ATX-MS-1467 administered by the intradermal route
358940|NCT01097668|E4|Reported Event|Subcutaneous Injection - Non Treatment Emergent|Follow-up period
358941|NCT01097668|E3|Reported Event|Intradermal Injection - Non Treatment Emergent|Follow-up period
358942|NCT01097668|E2|Reported Event|Subcutaneous Injection - Treatment Emergent|Injections will be administered by the subcutaneous route
358943|NCT01097668|E1|Reported Event|Intradermal Injection - Treatment Emergent|Injections will be administered by the intradermal route
358944|NCT01097655|B1|Baseline|HIV-infected Participants|HIV-infected participants starting with Kaletra tablets.
358945|NCT01097655|P1|Participant Flow|HIV-infected Participants|HIV-infected participants starting with Kaletra tablets.
358946|NCT01097655|O1|Outcome|HIV-infected Participants|HIV-infected participants starting with Kaletra tablets.
358947|NCT01097655|O1|Outcome|HIV-infected Participants|HIV-infected participants starting with Kaletra tablets.
358948|NCT01097655|O1|Outcome|HIV-infected Participants|HIV-infected participants starting with Kaletra tablets.
358949|NCT01097655|O1|Outcome|HIV-infected Participants|HIV-infected participants starting with Kaletra tablets.
358950|NCT01097655|E1|Reported Event|HIV-infected Participants|HIV-infected participants starting with Kaletra tablets.
358951|NCT01097629|B4|Baseline|Total|Total of all reporting groups
358952|NCT01097629|B3|Baseline|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
358953|NCT01097629|B2|Baseline|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
360990|NCT01091116|E4|Reported Event|Single High Dose|one dose+placebo
358954|NCT01097629|B1|Baseline|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
358955|NCT01097629|P8|Participant Flow|Placebo (RO, After Placebo in TRT)|After receiving placebo to suvorexant during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
358956|NCT01097629|P7|Participant Flow|Placebo (RO, After Suvorexant HD in TRT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
358957|NCT01097629|P6|Participant Flow|Suvorexant HD (RO, After Suvorexant HD in TRT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
358958|NCT01097629|P5|Participant Flow|Placebo (RO, After Suvorexant LD in TRT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
358959|NCT01097629|P4|Participant Flow|Suvorexant LD (Run-out [RO], After Suvorexant LD in TRT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
358960|NCT01097629|P3|Participant Flow|Placebo (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
358961|NCT01097629|P2|Participant Flow|Suvorexant High Dose (HD) (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
358962|NCT01097629|P1|Participant Flow|Suvorexant Low Dose (LD) (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
358963|NCT01097629|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
358964|NCT01097629|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
358965|NCT01097629|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
358966|NCT01097629|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
358967|NCT01097629|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
358968|NCT01097629|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
358969|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
358970|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
358971|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
358972|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
358973|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
358974|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
358975|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
358976|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
358977|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
358978|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
358979|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
358980|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
358981|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
358982|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
358983|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
358984|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
358985|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
358986|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
358987|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
358988|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
358989|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
358990|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
358991|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
358992|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
358993|NCT01097629|E16|Reported Event|Placebo (RO, After Placebo in TRT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received placebo during TRT and RO Phases.
358994|NCT01097629|E15|Reported Event|Placebo (RO, After Suvorexant HD in TRT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant HD during TRT Phase and placebo during RO Phase.
358995|NCT01097629|E14|Reported Event|Suvorexant HD (RO, After Suvorexant HD in TRT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant HD during TRT and RO Phases.
358996|NCT01097629|E13|Reported Event|Placebo (RO, After Suvorexant LD in TRT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant LD during TRT Phase and placebo during RO Phase.
358997|NCT01097629|E12|Reported Event|Suvorexant LD (RO, After Suvorexant LD in TRT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant LD during TRT and RO Phases.
358998|NCT01097629|E11|Reported Event|Placebo (TRT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT Phase participants who entered Follow-up directly from TRT Phase and had received placebo during TRT Phase.
358999|NCT01097629|E10|Reported Event|Suvorexant HD (TRT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT Phase participants who entered Follow-up directly from TRT Phase and had received suvorexant HD during TRT Phase.
359000|NCT01097629|E9|Reported Event|Suvorexant LD (TRT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT Phase participants who entered Follow-up directly from TRT Phase and had received suvorexant LD during TRT Phase.
359001|NCT01097629|E8|Reported Event|Placebo (RO, After Placebo in TRT)|After receiving placebo to suvorexant during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
359002|NCT01097629|E7|Reported Event|Placebo (RO, After Suvorexant HD in TRT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
359003|NCT01097629|E6|Reported Event|Suvorexant HD (RO, After Suvorexant HD in TRT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
359004|NCT01097629|E5|Reported Event|Placebo (RO, After Suvorexant LD in TRT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
359005|NCT01097629|E4|Reported Event|Suvorexant LD (RO, After Suvorexant LD in TRT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
359006|NCT01097629|E3|Reported Event|Placebo (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
359007|NCT01097629|E2|Reported Event|Suvorexant HD (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359008|NCT01097629|E1|Reported Event|Suvorexant LD (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359009|NCT01097616|B4|Baseline|Total|Total of all reporting groups
359010|NCT01097616|B3|Baseline|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
359011|NCT01097616|B2|Baseline|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359100|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
359012|NCT01097616|B1|Baseline|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359013|NCT01097616|P8|Participant Flow|Placebo (RO, After Placebo in TRT/EXT)|After receiving placebo to suvorexant during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
359014|NCT01097616|P7|Participant Flow|Placebo (RO, After Suvorexant HD in TRT/EXT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
359015|NCT01097616|P6|Participant Flow|Suvorexant HD (RO, After Suvorexant HD in TRT/EXT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
359016|NCT01097616|P5|Participant Flow|Placebo (RO, After Suvorexant LD in TRT/EXT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
359017|NCT01097616|P4|Participant Flow|Suvorexant LD (Run-out [RO], After Suvorexant LD in TRT/EXT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
359018|NCT01097616|P3|Participant Flow|Placebo (TRT/EXT Phase)|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase, and could continue on placebo to suvorexant during the optional 3-month DB EXT Phase.
359019|NCT01097616|P2|Participant Flow|Suvorexant High Dose (HD) (TRT/EXT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase, and could continue on same dose during the optional 3-month DB EXT Phase.
359020|NCT01097616|P1|Participant Flow|Suvorexant Low Dose (LD) (TRT/Extension [EXT] Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase, and could continue on same dose during the optional 3-month DB EXT Phase.
359021|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
359022|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359023|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
359024|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359025|NCT01097616|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
359026|NCT01097616|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359027|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359028|NCT01097616|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
359029|NCT01097616|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359030|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359031|NCT01097616|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
359032|NCT01097616|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359033|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359034|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
359035|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359036|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
359037|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359038|NCT01097616|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
359039|NCT01097616|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359040|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359041|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
359042|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359043|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
359044|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359045|NCT01097616|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
359046|NCT01097616|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359047|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359048|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
359049|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359050|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
359051|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359052|NCT01097616|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
359053|NCT01097616|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359054|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359055|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
359056|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359057|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
359058|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359059|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
359060|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359061|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
359062|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359063|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
359064|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359065|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
359066|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359067|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
359068|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359069|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
359070|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
360991|NCT01091116|E3|Reported Event|High Dose|two doses
359071|NCT01097616|E19|Reported Event|Placebo (RO, After Placebo in TRT/EXT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received placebo during TRT/EXT and RO Phases.
359072|NCT01097616|E18|Reported Event|Placebo (RO, After Suvorexant HD in TRT/EXT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant HD during TRT/EXT Phase and placebo during RO Phase.
359073|NCT01097616|E17|Reported Event|Suvorexant HD (RO, After Suvorexant HD in TRT/EXT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant HD during TRT/EXT and RO Phases.
359074|NCT01097616|E16|Reported Event|Placebo (RO, After Suvorexant LD in TRT/EXT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant LD during TRT/EXT Phase and placebo during RO Phase.
359075|NCT01097616|E15|Reported Event|Suvorexant LD (RO, After Suvorexant LD in TRT/EXT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant LD during TRT/EXT and RO Phases.
359076|NCT01097616|E14|Reported Event|Placebo (TRT/EXT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT/EXT participants who entered Follow-up directly from TRT or EXT Phase and had received placebo during TRT/EXT Phase.
359077|NCT01097616|E13|Reported Event|Suvorexant HD (TRT/EXT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT/EXT participants who entered Follow-up directly from TRT or EXT Phase and had received suvorexant HD during TRT/EXT Phase.
359078|NCT01097616|E12|Reported Event|Suvorexant LD (TRT/EXT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT/EXT participants who entered Follow-up directly from TRT or EXT Phase and had received suvorexant LD during TRT/EXT Phase.
359079|NCT01097616|E11|Reported Event|Placebo (RO, After Placebo in TRT/EXT)|After receiving placebo to suvorexant during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
359080|NCT01097616|E10|Reported Event|Placebo (RO, After Suvorexant HD in TRT/EXT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
359081|NCT01097616|E9|Reported Event|Suvorexant HD (RO, After Suvorexant HD in TRT/EXT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
359082|NCT01097616|E8|Reported Event|Placebo (RO, After Suvorexant LD in TRT/EXT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
359083|NCT01097616|E7|Reported Event|Suvorexant LD (RO, After Suvorexant LD in TRT/EXT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
359084|NCT01097616|E6|Reported Event|Placebo (EXT Phase)|After receiving placebo to suvorexant during the 3-month DB TRT Phase, participants could continue on placebo to suvorexant during the optional 3-month DB EXT Phase.
359085|NCT01097616|E5|Reported Event|Suvorexant HD (EXT Phase)|After receiving suvorexant HD during the 3-month DB TRT Phase, participants could continue on same dose during the optional 3-month DB EXT Phase.
359086|NCT01097616|E4|Reported Event|Suvorexant LD (EXT Phase)|After receiving suvorexant LD during the 3-month DB TRT Phase, participants could continue on same dose during the optional 3-month DB EXT Phase.
359087|NCT01097616|E3|Reported Event|Placebo (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
359088|NCT01097616|E2|Reported Event|Suvorexant HD (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359089|NCT01097616|E1|Reported Event|Suvorexant LD (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
359090|NCT01097460|B1|Baseline|MM-111 + Herceptin|"MM-111 will be combined with Herceptin~MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV"
359091|NCT01097460|P1|Participant Flow|MM-111 + Herceptin|"MM-111 will be combined with Herceptin~MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV"
359092|NCT01097460|O1|Outcome|MM-111 + Herceptin|"MM-111 will be combined with Herceptin~MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV"
359093|NCT01097460|E1|Reported Event|MM-111 + Herceptin|"MM-111 will be combined with Herceptin~MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV"
359094|NCT01097421|B1|Baseline|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
359095|NCT01097421|P1|Participant Flow|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
359096|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
359097|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
359098|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
359842|NCT01094730|O1|Outcome|Galyfilcon A Prototype Lens|Experimental silicone hydrogel contact lens.
359101|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
359102|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
359103|NCT01097421|E1|Reported Event|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
359104|NCT01097343|B1|Baseline|Cross-over Study|All Study Participants
359105|NCT01097343|P2|Participant Flow|150 mg First 30 Days, Followed by 75 mg|25 patients with the target allele were identified, and received 150 mg clopidogrel followed by 75 mg clopidogrel for two daily for separate dosing periods of 30 days
359106|NCT01097343|P1|Participant Flow|75 mg First 30 Days, Followed by 150 mg|25 patients with the target allele were identified, and receive 75mg followed by 150 mg clopidogrel daily for two separate dosing periods of 30 days
359107|NCT01097343|O2|Outcome|Cross-over Study - 150 mg Dose|Participants received standard dose clopidogrel (75 mg) and higher dose (150 mg) for 30 days
359108|NCT01097343|O1|Outcome|Cross-over Study- 75 mg Dose|Participants received standard dose clopidogrel (75 mg) and higher dose (150 mg) for 30 days
359109|NCT01097343|E2|Reported Event|150 mg Followed by 75 mg|Cross-over study
359110|NCT01097343|E1|Reported Event|75 mg Followed by 150 mg|Cross-over study
359111|NCT01097304|B1|Baseline|Treatment (Ursodiol)|"Patients receive ursodiol PO (13 to 15 mg/kg/day) BID for 6 months in the absence of disease progression or unacceptable toxicity.~Ursodiol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
359112|NCT01097304|P1|Participant Flow|Treatment (Ursodiol)|"Patients receive ursodiol PO (13 to 15 mg/kg/day) BID for 6 months in the absence of disease progression or unacceptable toxicity.~Ursodiol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
359113|NCT01097304|O1|Outcome|Treatment (Ursodiol)|"Patients receive ursodiol PO (13 to 15 mg/kg/day) BID for 6 months in the absence of disease progression or unacceptable toxicity.~Ursodiol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
359114|NCT01097304|O1|Outcome|Treatment (Ursodiol)|"Patients receive ursodiol PO (13 to 15 mg/kg/day) BID for 6 months in the absence of disease progression or unacceptable toxicity.~Ursodiol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
359115|NCT01097304|O1|Outcome|Treatment (Ursodiol)|"Patients receive ursodiol PO (13 to 15 mg/kg/day) BID for 6 months in the absence of disease progression or unacceptable toxicity.~Ursodiol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
359116|NCT01097304|O1|Outcome|Treatment (Ursodiol)|"Patients receive ursodiol PO BID for 6 months in the absence of disease progression or unacceptable toxicity.~Ursodiol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
359117|NCT01097304|E1|Reported Event|Treatment (Ursodiol)|"Patients receive ursodiol PO BID for 6 months in the absence of disease progression or unacceptable toxicity.~Ursodiol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
359118|NCT01097057|B1|Baseline|Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)|"Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.~Carboplatin: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Ifosfamide: Given IV~Leukapheresis: Given through catheter~Plerixafor: Given SC~Rituximab: Given IV"
359119|NCT01097057|P1|Participant Flow|Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)|"Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.~Carboplatin: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Ifosfamide: Given IV~Leukapheresis: Given through catheter~Plerixafor: Given SC~Rituximab: Given IV"
359120|NCT01097057|O1|Outcome|Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)|"Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.~Carboplatin: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Ifosfamide: Given IV~Leukapheresis: Given through catheter~Plerixafor: Given SC~Rituximab: Given IV"
359121|NCT01097057|O1|Outcome|Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)|"Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.~Carboplatin: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Ifosfamide: Given IV~Leukapheresis: Given through catheter~Plerixafor: Given SC~Rituximab: Given IV"
359122|NCT01097057|O1|Outcome|Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)|"Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.~Carboplatin: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Ifosfamide: Given IV~Leukapheresis: Given through catheter~Plerixafor: Given SC~Rituximab: Given IV"
359170|NCT01096784|P2|Participant Flow|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
359171|NCT01096784|P1|Participant Flow|rhIGF-1/rhIGFBP-3|Participants received insulin-like growth factor (rhIGF-I)/insulin-like growth factor binding protein-3 (rhIGFBP-3) 250 microgram per kilogram (mcg/kg) for 24 hours through continuous intravenous (IV) infusion from Day 0 up to 29 weeks 6 days of post-menstrual age (PMA).
359123|NCT01097057|O1|Outcome|Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)|"Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.~Carboplatin: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Ifosfamide: Given IV~Leukapheresis: Given through catheter~Plerixafor: Given SC~Rituximab: Given IV"
359124|NCT01097057|E1|Reported Event|Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)|"Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.~Carboplatin: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Ifosfamide: Given IV~Leukapheresis: Given through catheter~Plerixafor: Given SC~Rituximab: Given IV"
359125|NCT01097005|B1|Baseline|Clarithromycin|Those with an exposure
359126|NCT01097005|P1|Participant Flow|Clarithromycin|Those with an exposure
359127|NCT01097005|O1|Outcome|Clarithromycin|The subjects who completed the study
359128|NCT01097005|O1|Outcome|Clarithromycin|Those with an exposure
359129|NCT01097005|O1|Outcome|Clarithromycin|Negative conversion / Yes
359130|NCT01097005|E1|Reported Event|Clarithromycin|Those with an exposure
359131|NCT01096875|B3|Baseline|Total|Total of all reporting groups
359132|NCT01096875|B2|Baseline|Placebo|"Atorvastatin like pill~Placebo : 1tb/day once daily for two weeks prior to surgery"
359133|NCT01096875|B1|Baseline|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors~Atorvastatin : 40mg/day once daily for two weeks prior to surgery"
359134|NCT01096875|P2|Participant Flow|Placebo|"Atorvastatin like pill~Placebo : 1tb/day once daily for two weeks prior to surgery"
359135|NCT01096875|P1|Participant Flow|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors~Atorvastatin : 40mg/day once daily for two weeks prior to surgery"
359136|NCT01096875|O2|Outcome|Placebo|"Atorvastatin like pill~Placebo: 1tb/day once daily for two weeks prior to surgery"
359137|NCT01096875|O1|Outcome|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors~Atorvastatin: 40mg/day once daily for two weeks prior to surgery"
359138|NCT01096875|O2|Outcome|Placebo|"Atorvastatin like pill~Placebo: 1tb/day once daily for two weeks prior to surgery"
359139|NCT01096875|O1|Outcome|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors~Atorvastatin: 40mg/day once daily for two weeks prior to surgery"
359140|NCT01096875|O2|Outcome|Placebo|"Atorvastatin like pill~Placebo : 1tb/day once daily for two weeks prior to surgery"
359141|NCT01096875|O1|Outcome|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors~Atorvastatin : 40mg/day once daily for two weeks prior to surgery"
359142|NCT01096875|O2|Outcome|Placebo|"Atorvastatin like pill~Placebo : 1tb/day once daily for two weeks prior to surgery"
359143|NCT01096875|O1|Outcome|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors~Atorvastatin : 40mg/day once daily for two weeks prior to surgery"
359144|NCT01096875|E2|Reported Event|Placebo|"Atorvastatin like pill~Placebo : 1tb/day once daily for two weeks prior to surgery"
359145|NCT01096875|E1|Reported Event|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors~Atorvastatin : 40mg/day once daily for two weeks prior to surgery"
359146|NCT01096823|B3|Baseline|Total|Total of all reporting groups
359147|NCT01096823|B2|Baseline|Waitlist Control|Standard of care waitlist control group
359148|NCT01096823|B1|Baseline|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
359149|NCT01096823|P2|Participant Flow|Waitlist Control|Standard of care waitlist control group
359150|NCT01096823|P1|Participant Flow|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
359151|NCT01096823|O2|Outcome|Waitlist Control|Standard of care waitlist control group
359152|NCT01096823|O1|Outcome|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
359153|NCT01096823|O2|Outcome|Waitlist Control|Standard of care waitlist control group
359154|NCT01096823|O1|Outcome|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
359155|NCT01096823|O2|Outcome|Waitlist Control|Standard of care waitlist control group
359156|NCT01096823|O1|Outcome|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
359157|NCT01096823|O2|Outcome|Waitlist Control|Standard of care waitlist control group
359158|NCT01096823|O1|Outcome|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
359159|NCT01096823|E2|Reported Event|Waitlist Control|Standard of care waitlist control group
359160|NCT01096823|E1|Reported Event|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
359161|NCT01096810|B1|Baseline|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
359162|NCT01096810|P1|Participant Flow|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
359163|NCT01096810|O1|Outcome|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
359164|NCT01096810|O1|Outcome|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
359165|NCT01096810|O1|Outcome|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
359166|NCT01096810|E1|Reported Event|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
359167|NCT01096784|B3|Baseline|Total|Total of all reporting groups
359168|NCT01096784|B2|Baseline|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
359169|NCT01096784|B1|Baseline|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
359172|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
359173|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
359174|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
359175|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
359176|NCT01096784|O2|Outcome|Control|Participants in this control group do not received any treatment other than the standard care.
359177|NCT01096784|O1|Outcome|rhIGF-I/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
359178|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
359179|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
359180|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
359181|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
359182|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
359183|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
359184|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
359185|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
359186|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
359187|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
359188|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
359189|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
359190|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
359191|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
359192|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
359193|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
359194|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
359195|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
359196|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
359197|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
359198|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
359199|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
359200|NCT01096784|E2|Reported Event|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
359201|NCT01096784|E1|Reported Event|rhIGF-I/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
359202|NCT01096771|B3|Baseline|Total|Total of all reporting groups
359203|NCT01096771|B2|Baseline|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
359204|NCT01096771|B1|Baseline|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
359205|NCT01096771|P2|Participant Flow|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
359206|NCT01096771|P1|Participant Flow|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
359207|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
359208|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
359209|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
359210|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
359211|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
359212|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
359213|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
359214|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
359215|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
359216|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
360992|NCT01091116|E2|Reported Event|Mid Dose|two doses
359217|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
359218|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
359219|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
359220|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
359221|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
359222|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
359223|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
359224|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
359225|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
359226|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
359227|NCT01096771|E2|Reported Event|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
359228|NCT01096771|E1|Reported Event|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
359229|NCT01096680|B6|Baseline|Total|Total of all reporting groups
359230|NCT01096680|B5|Baseline|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359231|NCT01096680|B4|Baseline|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359232|NCT01096680|B3|Baseline|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359233|NCT01096680|B2|Baseline|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359234|NCT01096680|B1|Baseline|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359235|NCT01096680|P5|Participant Flow|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359236|NCT01096680|P4|Participant Flow|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359237|NCT01096680|P3|Participant Flow|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359238|NCT01096680|P2|Participant Flow|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359239|NCT01096680|P1|Participant Flow|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359240|NCT01096680|O5|Outcome|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359241|NCT01096680|O4|Outcome|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359242|NCT01096680|O3|Outcome|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359243|NCT01096680|O2|Outcome|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359244|NCT01096680|O1|Outcome|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359245|NCT01096680|O5|Outcome|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359246|NCT01096680|O4|Outcome|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359247|NCT01096680|O3|Outcome|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359248|NCT01096680|O2|Outcome|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359249|NCT01096680|O1|Outcome|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359250|NCT01096680|O5|Outcome|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359251|NCT01096680|O4|Outcome|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359252|NCT01096680|O3|Outcome|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359253|NCT01096680|O2|Outcome|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359254|NCT01096680|O1|Outcome|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359255|NCT01096680|O5|Outcome|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359256|NCT01096680|O4|Outcome|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359257|NCT01096680|O3|Outcome|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359258|NCT01096680|O2|Outcome|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359259|NCT01096680|O1|Outcome|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359260|NCT01096680|O5|Outcome|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359261|NCT01096680|O4|Outcome|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359262|NCT01096680|O3|Outcome|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
360993|NCT01091116|E1|Reported Event|Low Dose|two doses
359263|NCT01096680|O2|Outcome|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359264|NCT01096680|O1|Outcome|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359265|NCT01096680|E5|Reported Event|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359266|NCT01096680|E4|Reported Event|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359267|NCT01096680|E3|Reported Event|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359268|NCT01096680|E2|Reported Event|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359269|NCT01096680|E1|Reported Event|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
359270|NCT01096667|B6|Baseline|Total|Total of all reporting groups
359271|NCT01096667|B5|Baseline|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359272|NCT01096667|B4|Baseline|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359273|NCT01096667|B3|Baseline|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359274|NCT01096667|B2|Baseline|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359275|NCT01096667|B1|Baseline|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359276|NCT01096667|P5|Participant Flow|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359277|NCT01096667|P4|Participant Flow|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359278|NCT01096667|P3|Participant Flow|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359279|NCT01096667|P2|Participant Flow|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359280|NCT01096667|P1|Participant Flow|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to hydrochlorothiazide (HCTZ), once daily for 28 days.
359281|NCT01096667|O5|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359282|NCT01096667|O4|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359283|NCT01096667|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359284|NCT01096667|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359285|NCT01096667|O1|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359286|NCT01096667|O5|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359287|NCT01096667|O4|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359288|NCT01096667|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359289|NCT01096667|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359290|NCT01096667|O1|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359291|NCT01096667|O5|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359292|NCT01096667|O4|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359293|NCT01096667|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359294|NCT01096667|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359295|NCT01096667|O1|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359296|NCT01096667|O5|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359297|NCT01096667|O4|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359298|NCT01096667|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359299|NCT01096667|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359300|NCT01096667|O1|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359301|NCT01096667|O5|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359302|NCT01096667|O4|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359303|NCT01096667|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359304|NCT01096667|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359305|NCT01096667|O1|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359306|NCT01096667|O5|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359307|NCT01096667|O4|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359308|NCT01096667|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359309|NCT01096667|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359310|NCT01096667|O1|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359311|NCT01096667|O5|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359312|NCT01096667|O4|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359313|NCT01096667|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359314|NCT01096667|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359315|NCT01096667|O1|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359316|NCT01096667|O5|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359317|NCT01096667|O4|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359318|NCT01096667|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359319|NCT01096667|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359320|NCT01096667|O1|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359321|NCT01096667|O5|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359322|NCT01096667|O4|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359323|NCT01096667|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359324|NCT01096667|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359325|NCT01096667|O1|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359326|NCT01096667|O5|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359327|NCT01096667|O4|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359328|NCT01096667|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359329|NCT01096667|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359330|NCT01096667|O1|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359331|NCT01096667|O5|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359332|NCT01096667|O4|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359333|NCT01096667|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359334|NCT01096667|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359335|NCT01096667|O1|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359336|NCT01096667|O5|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359337|NCT01096667|O4|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359338|NCT01096667|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359339|NCT01096667|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359340|NCT01096667|O1|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359341|NCT01096667|O5|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359342|NCT01096667|O4|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359343|NCT01096667|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359344|NCT01096667|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359345|NCT01096667|O1|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359346|NCT01096667|O5|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359347|NCT01096667|O4|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359348|NCT01096667|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359349|NCT01096667|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359350|NCT01096667|O1|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359351|NCT01096667|O5|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359352|NCT01096667|O4|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359353|NCT01096667|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359354|NCT01096667|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359355|NCT01096667|O1|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359356|NCT01096667|O5|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359566|NCT01095978|E1|Reported Event|Klacid SR|Participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR
359357|NCT01096667|O4|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359358|NCT01096667|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359359|NCT01096667|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359360|NCT01096667|O1|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359361|NCT01096667|O5|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359362|NCT01096667|O4|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359363|NCT01096667|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359364|NCT01096667|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359365|NCT01096667|O1|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359366|NCT01096667|O5|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359367|NCT01096667|O4|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359368|NCT01096667|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359369|NCT01096667|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359370|NCT01096667|O1|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359371|NCT01096667|O5|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359372|NCT01096667|O4|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359373|NCT01096667|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359374|NCT01096667|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359375|NCT01096667|O1|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359376|NCT01096667|O5|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359377|NCT01096667|O4|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359378|NCT01096667|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359379|NCT01096667|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359380|NCT01096667|O1|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359381|NCT01096667|O5|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359382|NCT01096667|O4|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359383|NCT01096667|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359384|NCT01096667|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359385|NCT01096667|O1|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359386|NCT01096667|O5|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359387|NCT01096667|O4|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359388|NCT01096667|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359389|NCT01096667|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359390|NCT01096667|O1|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359391|NCT01096667|O5|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359392|NCT01096667|O4|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359393|NCT01096667|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359394|NCT01096667|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359395|NCT01096667|O1|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359396|NCT01096667|O5|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359397|NCT01096667|O4|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359398|NCT01096667|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359399|NCT01096667|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359400|NCT01096667|O1|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359401|NCT01096667|O5|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359402|NCT01096667|O4|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359403|NCT01096667|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
360544|NCT01092780|O3|Outcome|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
359404|NCT01096667|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359405|NCT01096667|O1|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359406|NCT01096667|O5|Outcome|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359407|NCT01096667|O4|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359408|NCT01096667|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359409|NCT01096667|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359410|NCT01096667|O1|Outcome|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359411|NCT01096667|E6|Reported Event|Pre-randomization|Blinded placebo was administered for at least 21 days prior to randomization.
359412|NCT01096667|E5|Reported Event|HCTZ 12.5mg|HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
359413|NCT01096667|E4|Reported Event|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
359414|NCT01096667|E3|Reported Event|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359415|NCT01096667|E2|Reported Event|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
359416|NCT01096667|E1|Reported Event|Placebo|Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
359417|NCT01096589|B5|Baseline|Total|Total of all reporting groups
359418|NCT01096589|B4|Baseline|Arm 4 - Commercial Compression System 5 Apps/wk|"Commercial Compression System 5 apps/wk~Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K)."
359419|NCT01096589|B3|Baseline|Arm 3 - 3M Oedema Reduction System|"3M Oedema Reduction System - 5 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
359420|NCT01096589|B2|Baseline|Arm 2 - 3M Oedema Reduction System|"3M Oedema Reduction System - 3 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
359421|NCT01096589|B1|Baseline|Arm 1 - 3M Oedema Reduction System|"3M Oedema Reduction System - 2 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
359422|NCT01096589|P4|Participant Flow|Arm 4 - Commercial Compression System 5 Apps/wk|"Commercial Compression System 5 apps/wk~Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K)."
359423|NCT01096589|P3|Participant Flow|Arm 3 - 3M Oedema Reduction System|"3M Oedema Reduction System - 5 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
359424|NCT01096589|P2|Participant Flow|Arm 2 - 3M Oedema Reduction System|"3M Oedema Reduction System - 3 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
359425|NCT01096589|P1|Participant Flow|Arm 1 - 3M Oedema Reduction System|"3M Oedema Reduction System - 2 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
359426|NCT01096589|O4|Outcome|Arm 4 - Commercial Compression System 5 Apps/wk|"Commercial Compression System 5 apps/wk~Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K)."
359427|NCT01096589|O3|Outcome|Arm 3 - 3M Oedema Reduction System|"3M Oedema Reduction System - 5 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
359428|NCT01096589|O2|Outcome|Arm 2 - 3M Oedema Reduction System|"3M Oedema Reduction System - 3 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
359429|NCT01096589|O1|Outcome|Arm 1 - 3M Oedema Reduction System|"3M Oedema Reduction System - 2 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
359430|NCT01096589|E4|Reported Event|Arm 4 - Commercial Compression System 5 Apps/wk|"Commercial Compression System 5 apps/wk~Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K)."
359431|NCT01096589|E3|Reported Event|Arm 3 - 3M Oedema Reduction System|"3M Oedema Reduction System - 5 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
359432|NCT01096589|E2|Reported Event|Arm 2 - 3M Oedema Reduction System|"3M Oedema Reduction System - 3 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
359433|NCT01096589|E1|Reported Event|Arm 1 - 3M Oedema Reduction System|"3M Oedema Reduction System - 2 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
359434|NCT01096550|B3|Baseline|Total|Total of all reporting groups
359435|NCT01096550|B2|Baseline|Outpatient|"Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.~Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling."
359436|NCT01096550|B1|Baseline|Intensive Outpatient|"Buprenorphine patients receiving 9 or more hours of outpatient counseling.~Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling."
359437|NCT01096550|P2|Participant Flow|Outpatient|"Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.~Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling."
359438|NCT01096550|P1|Participant Flow|Intensive Outpatient|"Buprenorphine patients receiving 9 or more hours of outpatient counseling.~Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling."
359439|NCT01096550|O2|Outcome|Outpatient|"Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.~Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling."
359440|NCT01096550|O1|Outcome|Intensive Outpatient|"Buprenorphine patients receiving 9 or more hours of outpatient counseling.~Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling."
359441|NCT01096550|E2|Reported Event|Outpatient|"Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.~Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling."
359741|NCT01095250|O2|Outcome|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
359442|NCT01096550|E1|Reported Event|Intensive Outpatient|"Buprenorphine patients receiving 9 or more hours of outpatient counseling.~Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling."
359443|NCT01096446|B3|Baseline|Total|Total of all reporting groups
359444|NCT01096446|B2|Baseline|Higher Infusion|Infants randomized into the control group will receive 2 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
359445|NCT01096446|B1|Baseline|Standard Infusion|Infants randomized into the experimental group will receive 0.5 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
359446|NCT01096446|P2|Participant Flow|Standard Infusion|Infants randomized into the control group will receive 0.5 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
359447|NCT01096446|P1|Participant Flow|Higher Infusion|Infants randomized into the experimental group will receive 2 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
359448|NCT01096446|O2|Outcome|Standard Infusion|Infants randomized into the control group will receive 0.5 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
359449|NCT01096446|O1|Outcome|Higher Infusion|Infants randomized into the experimental group will receive 2 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
359450|NCT01096446|E1|Reported Event|Serum Triglycerides|Serum triglycerides <201 mg/dl in both arms were considered to be normal. If serum triglycerides in either arm was above 201 mg/dl than the Intralipids was decreased based on the algorithm for adjusting IVFE when hypertriglyceridemia occured.
359451|NCT01096342|B1|Baseline|Phase II|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
359452|NCT01096342|P1|Participant Flow|Phase II: 50 mg/m^2|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
359453|NCT01096342|O1|Outcome|Phase II|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
359454|NCT01096342|O1|Outcome|Phase II|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
359455|NCT01096342|O1|Outcome|Phase II|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
359456|NCT01096342|E1|Reported Event|Phase II: 50 mg/m^2|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
359457|NCT01096316|B3|Baseline|Total|Total of all reporting groups
359458|NCT01096316|B2|Baseline|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
359459|NCT01096316|B1|Baseline|Intervention|"The intervention will integrate care between a depression care manager, consulting study team (psychiatry, psychology, OB-GYN researchers) and OB-GYN clinic providers. The 3-part intervention includes:~enhanced education of patients and providers~engagement of patients~depression care management with patient choice of initial antidepressant medication or Problem-Solving Treatment-Primary Care and behavioral activation.~Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention. Patients choose either medication or Problem-Solving Treatment-Primary Care therapy. Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST,"
359460|NCT01096316|P2|Participant Flow|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
359461|NCT01096316|P1|Participant Flow|Intervention|"The intervention will integrate care between a depression care manager, consulting study team (psychiatry, psychology, OB-GYN researchers) and OB-GYN clinic providers. The 3-part intervention includes:~enhanced education of patients and providers~engagement of patients~depression care management with patient choice of initial antidepressant medication or Problem-Solving Treatment-Primary Care and behavioral activation.~Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention. Patients choose either medication or Problem-Solving Treatment-Primary Care therapy. Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST,"
359687|NCT01095653|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
359462|NCT01096316|O2|Outcome|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
359463|NCT01096316|O1|Outcome|Intervention|"The intervention will integrate care between a depression care manager, consulting study team (psychiatry, psychology, OB-GYN researchers) and OB-GYN clinic providers. The 3-part intervention includes:~enhanced education of patients and providers~engagement of patients~depression care management with patient choice of initial antidepressant medication or Problem-Solving Treatment-Primary Care and behavioral activation.~Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention. Patients choose either medication or Problem-Solving Treatment-Primary Care therapy. Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST,"
359464|NCT01096316|O2|Outcome|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
359465|NCT01096316|O1|Outcome|Intervention|"The intervention will integrate care between a depression care manager, consulting study team (psychiatry, psychology, OB-GYN researchers) and OB-GYN clinic providers. The 3-part intervention includes:~enhanced education of patients and providers~engagement of patients~depression care management with patient choice of initial antidepressant medication or Problem-Solving Treatment-Primary Care and behavioral activation.~Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention. Patients choose either medication or Problem-Solving Treatment-Primary Care therapy. Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST,"
359466|NCT01096316|O2|Outcome|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
359467|NCT01096316|O1|Outcome|Intervention|"The intervention will integrate care between a depression care manager, consulting study team (psychiatry, psychology, OB-GYN researchers) and OB-GYN clinic providers. The 3-part intervention includes:~enhanced education of patients and providers~engagement of patients~depression care management with patient choice of initial antidepressant medication or Problem-Solving Treatment-Primary Care and behavioral activation.~Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention. Patients choose either medication or Problem-Solving Treatment-Primary Care therapy. Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST,"
359468|NCT01096316|E2|Reported Event|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
359469|NCT01096316|E1|Reported Event|Intervention|"The intervention will integrate care between a depression care manager(DCM), consulting study team (psychiatry OB-GYN physician) and OB-GYN clinic providers.~Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). The DCM in a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the 12-month intervention. Patients choose either medication or Problem-Solving Treatment. Depressive symptoms are assessed at each visit with the PHQ-9. Patients with inadequate response after 4 to 8 weeks to the first choice will switch or combine treatments. DCMs partcipate in weekly caseload review with a psychiatrist and Ob-Gyn physician who make treatment recommendations that the DCM then communicates to the patient's own Ob-Gyn physician who writes all prescriptions."
359470|NCT01096186|B1|Baseline|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
359471|NCT01096186|P1|Participant Flow|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
359472|NCT01096186|O1|Outcome|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
359473|NCT01096186|O1|Outcome|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
359474|NCT01096186|O1|Outcome|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
359475|NCT01096186|E1|Reported Event|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
359476|NCT01096056|B3|Baseline|Total|Total of all reporting groups
359477|NCT01096056|B2|Baseline|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
359478|NCT01096056|B1|Baseline|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
359688|NCT01095653|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
359479|NCT01096056|P2|Participant Flow|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
359480|NCT01096056|P1|Participant Flow|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
359481|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
359482|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
359483|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
359484|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
359485|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
359486|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
359487|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
359488|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
359489|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
359490|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
359491|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
359492|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
359493|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
359494|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
359495|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
359496|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
359497|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
359498|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
359499|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
359500|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
359501|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
359502|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
359503|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
359504|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
359505|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
359506|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
359507|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
359508|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
359509|NCT01096056|E2|Reported Event|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
359510|NCT01096056|E1|Reported Event|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
359511|NCT01096017|B1|Baseline|All Study Participants|
359512|NCT01096017|P2|Participant Flow|Terbutaline First, Then Salbutamol|Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI ⇒Salbutamol pMDI 200 μg +placebo Turbuhaler®
359513|NCT01096017|P1|Participant Flow|Salbutamol First, Then Terbutaline|Salbutamol pMDI 200 μg +placebo Turbuhaler® ⇒Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI
359514|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
359515|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
359516|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
359517|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
359518|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
359519|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
359520|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
359521|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
359522|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
359523|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
359524|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
359525|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
359526|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
359527|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
359528|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
359529|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
359530|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
359531|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
359532|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
359533|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
359534|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
359535|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
359536|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
359537|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
359538|NCT01096017|E2|Reported Event|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose.
359539|NCT01096017|E1|Reported Event|Salbutamol pMDI|200 μg, inhalation, single dose.
359540|NCT01095978|B1|Baseline|Klacid SR|The per-protocol population (2800 participants) with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
359541|NCT01095978|P1|Participant Flow|Klacid SR|Participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR
359542|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
359543|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
359544|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
359545|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
359546|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
359547|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
359548|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
359549|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
359550|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
359551|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
359552|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
359553|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
359554|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
359555|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
359556|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
359557|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
359558|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
359559|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
359560|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
359561|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
359562|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
359563|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
359564|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
359565|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
359567|NCT01095887|B1|Baseline|Eculizumab|"Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.~Eculizumab: Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels."
359568|NCT01095887|P1|Participant Flow|Eculizumab|"Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.~Eculizumab: Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels."
359569|NCT01095887|O1|Outcome|Eculizumab|Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.
359570|NCT01095887|E1|Reported Event|Eculizumab|"Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.~Eculizumab: Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels."
359571|NCT01095835|B4|Baseline|Total|Total of all reporting groups
359572|NCT01095835|B3|Baseline|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
359573|NCT01095835|B2|Baseline|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
359574|NCT01095835|B1|Baseline|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
359575|NCT01095835|P3|Participant Flow|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 milligrams (mg) of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
359576|NCT01095835|P2|Participant Flow|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
359577|NCT01095835|P1|Participant Flow|PEG-IFN48|Treatment with pegylated interferon (PEG-IFN) alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
359578|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
359579|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
359580|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
359581|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
359582|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
359583|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
359584|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
359585|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
359586|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
359742|NCT01095250|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
359587|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
359588|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
359589|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
359590|NCT01095835|O1|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
359591|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
359592|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
359593|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
359594|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
359595|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
359596|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
359597|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
359598|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
359599|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
359600|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
359601|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
359602|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
359603|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
359604|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
359605|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
359689|NCT01095653|E3|Reported Event|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
359606|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
359607|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
359608|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
359609|NCT01095835|E3|Reported Event|PEG-IFN + LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 milligrams (mg) of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
359610|NCT01095835|E2|Reported Event|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
359611|NCT01095835|E1|Reported Event|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
359612|NCT01095796|B3|Baseline|Total|Total of all reporting groups
359613|NCT01095796|B2|Baseline|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
359614|NCT01095796|B1|Baseline|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
359615|NCT01095796|P2|Participant Flow|Atripla|Atripla® (efavirenz (EFV) 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
359616|NCT01095796|P1|Participant Flow|Stribild|Stribild® (elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg) single-tablet regimen (STR) once daily plus placebo to match Atripla once daily prior to bedtime
359617|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
359618|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
359619|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
359620|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
359621|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
359622|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
359623|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
359624|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
359625|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
359626|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
359627|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
359628|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
359629|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
359630|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
359631|NCT01095796|E2|Reported Event|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
359632|NCT01095796|E1|Reported Event|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
359633|NCT01095757|B1|Baseline|Plerixafor + Chemo and G-CSF|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
359634|NCT01095757|P1|Participant Flow|Plerixafor + Chemo and G-CSF|"Patients who receive a combination of Plerixafor, chemotherapy and granulocyte-colony stimulating factor (G-CSF).~Plerixafor : 240 µg/kg subcutaneous injection on the day that the absolute neutrophil count (ANC) is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target cluster of differentiation 34 (CD34) cell dose has been reached."
359635|NCT01095757|O2|Outcome|Lymphoma|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
359636|NCT01095757|O1|Outcome|Multiple Myeloma|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
359637|NCT01095757|O2|Outcome|Lymphoma|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
359638|NCT01095757|O1|Outcome|Multiple Myeloma|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
359639|NCT01095757|O2|Outcome|Lymphoma|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
359640|NCT01095757|O1|Outcome|Multiple Myeloma|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
359641|NCT01095757|E1|Reported Event|Plerixafor + Chemo and G-CSF|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
359642|NCT01095666|B4|Baseline|Total|Total of all reporting groups
359643|NCT01095666|B3|Baseline|Dapagliflozin 10 mg + Metformin|
359644|NCT01095666|B2|Baseline|Dapagliflozin 5 mg + Metformin|
359645|NCT01095666|B1|Baseline|Placebo + Metformin|
359646|NCT01095666|P3|Participant Flow|Dapagliflozin 10 mg + Metformin|
359647|NCT01095666|P2|Participant Flow|Dapagliflozin 5 mg + Metformin|
359648|NCT01095666|P1|Participant Flow|Placebo + Metformin|
359649|NCT01095666|O3|Outcome|Dapagliflozin 10 mg + Metformin|
359650|NCT01095666|O2|Outcome|Dapagliflozin 5 mg + Metformin|
359651|NCT01095666|O1|Outcome|Placebo + Metformin|
359652|NCT01095666|O3|Outcome|Dapagliflozin 10 mg + Metformin|
359653|NCT01095666|O2|Outcome|Dapagliflozin 5 mg + Metformin|
359654|NCT01095666|O1|Outcome|Placebo + Metformin|
359655|NCT01095666|O3|Outcome|Dapagliflozin 10 mg + Metformin|
359656|NCT01095666|O2|Outcome|Dapagliflozin 5 mg + Metformin|
359657|NCT01095666|O1|Outcome|Placebo + Metformin|
359658|NCT01095666|O3|Outcome|Dapagliflozin 10 mg + Metformin|
359659|NCT01095666|O2|Outcome|Dapagliflozin 5 mg + Metformin|
359660|NCT01095666|O1|Outcome|Placebo + Metformin|
359661|NCT01095666|O3|Outcome|Dapagliflozin 10 mg + Metformin|
359662|NCT01095666|O2|Outcome|Dapagliflozin 5 mg + Metformin|
359663|NCT01095666|O1|Outcome|Placebo + Metformin|
359664|NCT01095666|E3|Reported Event|Dapagliflozin 10 mg + Metformin|
359665|NCT01095666|E2|Reported Event|Dapagliflozin 5 mg + Metformin|
359666|NCT01095666|E1|Reported Event|Placebo + Metformin|
359667|NCT01095653|B4|Baseline|Total|Total of all reporting groups
359668|NCT01095653|B3|Baseline|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
359669|NCT01095653|B2|Baseline|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
359670|NCT01095653|B1|Baseline|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
359671|NCT01095653|P3|Participant Flow|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
359672|NCT01095653|P2|Participant Flow|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
359673|NCT01095653|P1|Participant Flow|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
359674|NCT01095653|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
359675|NCT01095653|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
359676|NCT01095653|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
359677|NCT01095653|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
359678|NCT01095653|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
359679|NCT01095653|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
359680|NCT01095653|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
359681|NCT01095653|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
359682|NCT01095653|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
359683|NCT01095653|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
359684|NCT01095653|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
359685|NCT01095653|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
359686|NCT01095653|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
359690|NCT01095653|E2|Reported Event|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
359691|NCT01095653|E1|Reported Event|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
359692|NCT01095510|B4|Baseline|Total|Total of all reporting groups
359693|NCT01095510|B3|Baseline|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
359694|NCT01095510|B2|Baseline|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
359695|NCT01095510|B1|Baseline|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
359696|NCT01095510|P4|Participant Flow|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
359697|NCT01095510|P3|Participant Flow|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
359698|NCT01095510|P2|Participant Flow|1000 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
359699|NCT01095510|P1|Participant Flow|500 U CINRYZE (10-25 kg Body Weight)|Single intravenous (IV) dose of 500 U CINRYZE
359700|NCT01095510|O3|Outcome|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
359701|NCT01095510|O2|Outcome|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
359702|NCT01095510|O1|Outcome|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
359703|NCT01095510|O3|Outcome|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
359704|NCT01095510|O2|Outcome|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
359705|NCT01095510|O1|Outcome|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
359706|NCT01095510|O3|Outcome|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
359707|NCT01095510|O2|Outcome|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
359708|NCT01095510|O1|Outcome|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
359709|NCT01095510|O3|Outcome|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
359710|NCT01095510|O2|Outcome|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
359711|NCT01095510|O1|Outcome|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
359712|NCT01095510|E3|Reported Event|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
359713|NCT01095510|E2|Reported Event|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
359714|NCT01095510|E1|Reported Event|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
359715|NCT01095497|B3|Baseline|Total|Total of all reporting groups
359716|NCT01095497|B2|Baseline|IV CINRYZE First, Then SC CINRYZE Dose 2|Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of IV CINRYZE twice weekly for two weeks. In Period 2, subjects received 2000 Units of SC CINRYZE twice weekly for two weeks.
359717|NCT01095497|B1|Baseline|IV CINRYZE First, Then SC CINRYZE Dose 1|Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of IV CINRYZE twice weekly for two weeks. In Period 2, subjects received 1000 Units of SC CINRYZE twice weekly for two weeks.
359718|NCT01095497|P2|Participant Flow|IV CINRYZE First, Then SC CINRYZE Dose 2|Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of IV CINRYZE twice weekly for two weeks. In Period 2, subjects received 2000 Units of SC CINRYZE twice weekly for two weeks.
359719|NCT01095497|P1|Participant Flow|IV CINRYZE First, Then SC CINRYZE Dose 1|Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of intravenous (IV) CINRYZE twice weekly for two weeks. In Period 2, subjects received 1000 Units of subcutaneous (SC) CINRYZE twice weekly for two weeks.
359720|NCT01095497|O3|Outcome|SC CINRYZE Dose 2|2000 Units of SC CINRYZE twice weekly for two weeks
359721|NCT01095497|O2|Outcome|SC CINRYZE Dose 1|1000 Units of SC CINRYZE twice weekly for two weeks
359722|NCT01095497|O1|Outcome|IV CINRYZE|1000 Units of IV CINRYZE twice weekly for two weeks
359723|NCT01095497|E3|Reported Event|SC CINRYZE Dose 2|2000 Units of SC CINRYZE twice weekly for two weeks
359724|NCT01095497|E2|Reported Event|SC CINRYZE Dose 1|1000 Units of SC CINRYZE twice weekly for two weeks
359725|NCT01095497|E1|Reported Event|IV CINRYZE|1000 Units of IV CINRYZE twice weekly for two weeks
359726|NCT01095250|B5|Baseline|Total|Total of all reporting groups
359727|NCT01095250|B4|Baseline|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
359728|NCT01095250|B3|Baseline|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
359729|NCT01095250|B2|Baseline|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
359730|NCT01095250|B1|Baseline|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
359731|NCT01095250|P4|Participant Flow|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
359732|NCT01095250|P3|Participant Flow|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg subcutaneously at baseline and Week 2, then every 4 weeks.
359733|NCT01095250|P2|Participant Flow|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
359734|NCT01095250|P1|Participant Flow|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
359735|NCT01095250|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
359736|NCT01095250|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
359737|NCT01095250|O2|Outcome|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
359738|NCT01095250|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
359739|NCT01095250|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
359740|NCT01095250|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
359743|NCT01095250|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
359744|NCT01095250|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
359745|NCT01095250|O2|Outcome|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
359746|NCT01095250|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
359747|NCT01095250|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
359748|NCT01095250|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
359749|NCT01095250|O2|Outcome|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
359750|NCT01095250|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
359751|NCT01095250|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
359752|NCT01095250|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
359753|NCT01095250|O2|Outcome|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
359754|NCT01095250|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
359755|NCT01095250|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
359756|NCT01095250|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
359757|NCT01095250|O2|Outcome|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
359758|NCT01095250|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
359759|NCT01095250|E4|Reported Event|Placebo Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
359760|NCT01095250|E3|Reported Event|AIN457 150mg Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
359761|NCT01095250|E2|Reported Event|AIN457 300mg Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
359762|NCT01095250|E1|Reported Event|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. at baseline, Week 1 and Week 2, then every 2 weeks
359763|NCT01095094|B1|Baseline|Arm I|"Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.~ritonavir : Given orally~lopinavir : Given orally"
359764|NCT01095094|P1|Participant Flow|Arm I|"Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.~ritonavir : Given orally~lopinavir : Given orally"
359765|NCT01095094|O1|Outcome|Arm I|"Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.~ritonavir : Given orally~lopinavir : Given orally"
359766|NCT01095094|O1|Outcome|Arm I|"Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.~ritonavir : Given orally~lopinavir : Given orally"
359767|NCT01095094|E1|Reported Event|Arm I|"Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.~ritonavir : Given orally~lopinavir : Given orally"
359768|NCT01094886|B1|Baseline|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
359769|NCT01094886|P1|Participant Flow|Rivaroxaban|10 mg PO (orally) qd (once daily) for up to 35 days for total hip replacement (THR) and 14 days for total knee replacement (TKR)
359770|NCT01094886|O1|Outcome|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
359771|NCT01094886|O1|Outcome|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
359772|NCT01094886|O1|Outcome|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
359773|NCT01094886|O1|Outcome|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
359774|NCT01094886|E1|Reported Event|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
359775|NCT01094808|B4|Baseline|Total|Total of all reporting groups
359776|NCT01094808|B3|Baseline|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
359777|NCT01094808|B2|Baseline|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
359778|NCT01094808|B1|Baseline|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
359779|NCT01094808|P3|Participant Flow|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
359780|NCT01094808|P2|Participant Flow|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
359781|NCT01094808|P1|Participant Flow|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
359782|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
359783|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
359784|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
359785|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
359786|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
359787|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
359788|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
359789|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
359790|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
359791|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
359792|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
359793|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
359794|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
359795|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
359796|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
359797|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
359798|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
359799|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
359800|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
359801|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
359802|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
359803|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
359804|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
359805|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
359806|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
359807|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
359808|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
359809|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
359810|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
359811|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
359812|NCT01094808|E3|Reported Event|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
359813|NCT01094808|E2|Reported Event|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
359814|NCT01094808|E1|Reported Event|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
359815|NCT01094743|B1|Baseline|Galyfilcon A Prototype Lens / Lotrafilcon B Lens|All enrolled subjects were to wear both lenses through the course of the study.
359816|NCT01094743|P1|Participant Flow|Galyfilcon A Prototype Lens / Lotrafilcon B Lens|All enrolled subjects were to wear both lenses through the course of the study.
359817|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
359818|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
359819|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
359820|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
359821|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
359822|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
359823|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
359824|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
359825|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
359826|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
359827|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
359828|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
359829|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
359830|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
359831|NCT01094743|E1|Reported Event|Galyfilcon A Prototype Lens / Lotrafilcon B Lens|All enrolled subjects were to wear both lenses through the course of the study.
359832|NCT01094730|B1|Baseline|All Subjects|All enrolled subjects who have the demographic data and worn at least one study lens.
359833|NCT01094730|P2|Participant Flow|Marketed Galyfilcon A/Galyfilcon A Prototype|The marketed galyfilcon A lens worn daily for 12-16 days during the first period then the galyfilcon A prototype lens worn daily for 12-16 days during the second period.
359834|NCT01094730|P1|Participant Flow|Galyfilcon A Prototype/Marketed Galyfilcon A|The galyfilcon A prototype lens worn daily for 12-16 days during the first period then marketed galyfilcon A lens worn daily for 12-16 days during the second period.
359835|NCT01094730|O2|Outcome|Marketed Galyfilcon A Lens|Marketed silicon hydrogel contact lens.
359836|NCT01094730|O1|Outcome|Galyfilcon A Prototype Lens|Experimental silicon hydrogel contact lens.
359837|NCT01094730|O2|Outcome|Marketed Galyfilcon A Lens|Marketed silicon hydrogel contact lens.
359838|NCT01094730|O1|Outcome|Galyfilcon A Prototype Lens|Experimental silicon hydrogel contact lens.
359839|NCT01094730|O2|Outcome|Marketed Galyfilcon A Lens|Marketed silicon hydrogel contact lens.
359840|NCT01094730|O1|Outcome|Galyfilcon A Prototype Lens|Experimental silicon hydrogel contact lens.
359841|NCT01094730|O2|Outcome|Marketed Galyfilcon A Lens|Marketed silicone hydrogel contact lens.
359843|NCT01094730|E1|Reported Event|All Subjects|All subjects were to wear both lenses during the course of the study.
359844|NCT01094704|B3|Baseline|Total|Total of all reporting groups
359845|NCT01094704|B2|Baseline|Hypertonic Saline - 4 Hours|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment four hours post-dose.
359846|NCT01094704|B1|Baseline|Hypertonic Saline - 1 Hour|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment one hour post-dose.
359847|NCT01094704|P2|Participant Flow|Hypertonic Saline - 4 Hours|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment four hours post-dose.
359848|NCT01094704|P1|Participant Flow|Hypertonic Saline - 1 Hour|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment one hour post-dose.
359849|NCT01094704|O2|Outcome|Hypertonic Saline - 4 Hours|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment four hours post-dose.
359850|NCT01094704|O1|Outcome|Hypertonic Saline - 1 Hour|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment one hour post-dose.
359851|NCT01094704|E2|Reported Event|Hypertonic Saline - 4 Hours|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment four hours post-dose.
359852|NCT01094704|E1|Reported Event|Hypertonic Saline - 1 Hour|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment one hour post-dose.
359853|NCT01094574|B7|Baseline|Total|Total of all reporting groups
359854|NCT01094574|B6|Baseline|Placebo -Alfentanil - Propanolol|Participants were randomized to receive an intravenous infusion of normal saline, alfentanil, and propanolol on 3 consecutive study days.
359855|NCT01094574|B5|Baseline|Propranolol - Alfentanil - Placebo|Participants were randomized to receive an intravenous infusion of propanolol, alfentanil, and normal saline on 3 consecutive study days.
359856|NCT01094574|B4|Baseline|Alfentanil - Propanolol - Placebo|Participants were randomized to receive an intravenous infusion of alfentanil, propanolol, and normal saline on 3 consecutive study days.
359857|NCT01094574|B3|Baseline|Placebo - Propanolol - Alfentanil|Participants were randomized to receive an intravenous infusion of normal saline, propanolol, and alfentanil on 3 consecutive study days.
359858|NCT01094574|B2|Baseline|Propranolol - Placebo - Alfentanil|Participants were randomized to receive an intravenous infusion of propanolol, normal saline, and alfentanil on 3 consecutive study days.
359859|NCT01094574|B1|Baseline|Alfentanil - Placebo - Propanolol|Participant(s) were randomized to receive an intravenous infusion of alfentanil, normal saline, and propanolol on 3 consecutive study days.
359860|NCT01094574|P6|Participant Flow|Placebo Day 1, Alfentanil Day 2, and Propranolol Day 3|"Day 1: Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump.~Day 2: Experimental inflammation, and tissue injury sites were created an infusion of alfentanil 100ng/ml was administered over 3 hours.~Day 3: Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours.~On all study days data were collected to measure inflammation, pain response, and cytokine levels locally.~Experimental inflammation and tissue injury sites were used for pain testing to determine heat and mechanical pain threshold.~Interstitial fluid sampling was accomplished with microdialysis. Samples were collected hourly throughout the study day.~Laser doppler evaluation of tissue perfusion was made at baseline and again at hours 1, 2 and 3 following initiation of the infusions."
359861|NCT01094574|P5|Participant Flow|Propranolol Day 1, Alfentanil Day 2, and Placebo Day 3|"Day 1: Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours.~Day 2: Experimental inflammation, and tissue injury sites were created an infusion of alfentanil 100ng/ml was administered over 3 hours.~Day 3: Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump.~On all study days data were collected to measure inflammation, pain response, and cytokine levels locally.~Experimental inflammation and tissue injury sites were used for pain testing to determine heat and mechanical pain threshold.~Interstitial fluid sampling was accomplished with microdialysis. Samples were collected hourly throughout the study day.~Laser doppler evaluation of tissue perfusion was made at baseline and again at hours 1, 2 and 3 following initiation of the infusions."
359862|NCT01094574|P4|Participant Flow|Alfentanil Day 1, Propranolol Day 2, and Palcebo Day 3|"Day 1: Experimental inflammation, and tissue injury sites were created an infusion of alfentanil 100ng/ml was administered over 3 hours.~Day 2: Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours.~Day 3: Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump.~On all study days data were collected to measure inflammation, pain response, and cytokine levels locally.~Experimental inflammation and tissue injury sites were used for pain testing to determine heat and mechanical pain threshold.~Interstitial fluid sampling was accomplished with microdialysis. Samples were collected hourly throughout the study day.~Laser doppler evaluation of tissue perfusion was made at baseline and again at hours 1, 2 and 3 following initiation of the infusions."
359863|NCT01094574|P3|Participant Flow|Placebo Day 1, Propranolol Day 2, and Alfentanil Day 3|"Day 1: Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump.~Day 2: Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours.~Day 3: Experimental inflammation, and tissue injury sites were created an infusion of alfentanil 100ng/ml was administered over 3 hours.~On all study days data were collected to measure inflammation, pain response, and cytokine levels locally.~Experimental inflammation and tissue injury sites were used for pain testing to determine heat and mechanical pain threshold.~Interstitial fluid sampling was accomplished with microdialysis. Samples were collected hourly throughout the study day.~Laser doppler evaluation of tissue perfusion was made at baseline and again at hours 1, 2 and 3 following initiation of the infusions."
359884|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359885|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359864|NCT01094574|P2|Participant Flow|Propranolol Day 1, Placebo Day 2, and Alfentanil Day 3|"Day 1: Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours.~Day 2: Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump.~Day 3: Experimental inflammation, and tissue injury sites were created an infusion of alfentanil 100ng/ml was administered over 3 hours.~On all study days data were collected to measure inflammation, pain response, and cytokine levels locally.~Experimental inflammation and tissue injury sites were used for pain testing to determine heat and mechanical pain threshold.~Interstitial fluid sampling was accomplished with microdialysis. Samples were collected hourly throughout the study day.~Laser doppler evaluation of tissue perfusion was made at baseline and again at hours 1, 2 and 3 following initiation of the infusions."
359865|NCT01094574|P1|Participant Flow|Alfentanil Day 1, Placebo Day 2, and Propranolol Day 3|"Day 1: Experimental inflammation, and tissue injury sites were created an infusion of alfentanil 100ng/ml was administered over 3 hours.~Day 2: Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours.~Day 3: Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump.~On all study days data were collected to measure inflammation, pain response, and cytokine levels locally.~Experimental inflammation and tissue injury sites were used for pain testing to determine heat and mechanical pain threshold.~Interstitial fluid sampling was accomplished with microdialysis. Samples were collected hourly throughout the study day.~Laser doppler evaluation of tissue perfusion was made at baseline and again at hours 1, 2 and 3 following initiation of the infusions."
359866|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359867|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359868|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359869|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359870|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359871|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359872|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359873|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359874|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359875|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359876|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359877|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359878|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359879|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359880|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359881|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359882|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359883|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
360545|NCT01092780|O2|Outcome|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
359886|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359887|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359888|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359889|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359890|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359891|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359892|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359893|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359894|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359895|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359896|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359897|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359898|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359899|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359900|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359901|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359902|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359903|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359904|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
359905|NCT01094574|E6|Reported Event|Placebo -Alfentanil - Propanolol|"An infusion of normal saline was administered over 3 hours on study 1. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of alfentanil 100ng/ml was administered over 3 hours on study 2. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of propranolol 30ng/ml was administered over 3 hours on study day 3. Data were collected to measure inflammation, pain response, and cytokine levels locally."
359906|NCT01094574|E5|Reported Event|Propranolol - Alfentanil - Placebo|"An infusion of propranolol 30ng/ml was administered over 3 hours on study day 1. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of alfentanil 100ng/ml was administered over 3 hours on study 2. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of normal saline was administered over 3 hours on study 3. Data were collected to measure inflammation, pain response, and cytokine levels locally."
359907|NCT01094574|E4|Reported Event|Alfentanil - Propanolol - Placebo|"An infusion of alfentanil 100ng/ml was administered over 3 hours on study 1. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of propranolol 30ng/ml was administered over 3 hours on study day 2. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of normal saline was administered over 3 hours on study 3. Data were collected to measure inflammation, pain response, and cytokine levels locally."
361640|NCT01089517|P1|Participant Flow|Lucentis|Sham/Lucentis 0.5 mg
359908|NCT01094574|E3|Reported Event|Placebo - Propanolol - Alfentanil|"An infusion of normal saline was administered over 3 hours on study 1. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of propranolol 30ng/ml was administered over 3 hours on study day 2. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of alfentanil 100ng/ml was administered over 3 hours on study 3. Data were collected to measure inflammation, pain response, and cytokine levels locally."
359909|NCT01094574|E2|Reported Event|Propranolol - Placebo - Alfentanil|"An infusion of propranolol 30ng/ml was administered over 3 hours on study day 1. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of normal saline was administered over 3 hours on study 2. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of alfentanil 100ng/ml was administered over 3 hours on study 3. Data were collected to measure inflammation, pain response, and cytokine levels locally."
359910|NCT01094574|E1|Reported Event|Alfentanil - Placebo - Propanolol|"An infusion of alfentanil 100ng/ml was administered over 3 hours on study 1. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of normal saline was administered over 3 hours on study 2. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of propranolol 30ng/ml was administered over 3 hours on study day 3. Data were collected to measure inflammation, pain response, and cytokine levels locally."
359911|NCT01094561|B1|Baseline|Synthetic Human Secretin|"Single arm (open label).~Subjects will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg."
359912|NCT01094561|P1|Participant Flow|Synthetic Human Secretin|"Single arm (open label).~Subjects will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg."
359913|NCT01094561|O1|Outcome|Synthetic Human Secretin|"Single arm (open label).~Synthetic Human Secretin: Twenty five patients will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg."
359914|NCT01094561|O1|Outcome|Synthetic Human Secretin|"Single arm (open label).~Synthetic Human Secretin: Twenty five patients will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg."
359915|NCT01094561|E1|Reported Event|Synthetic Human Secretin|"Single arm (open label).~Synthetic Human Secretin: Twenty five patients will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg."
359916|NCT01094548|B3|Baseline|Total|Total of all reporting groups
359917|NCT01094548|B2|Baseline|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
359918|NCT01094548|B1|Baseline|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
359919|NCT01094548|P2|Participant Flow|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
359920|NCT01094548|P1|Participant Flow|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide (L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
359955|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360546|NCT01092780|O1|Outcome|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
359921|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
359922|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
359923|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
359924|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
359925|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
359926|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
359927|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
359928|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
359939|NCT01094522|B1|Baseline|Methadone|"One half the Study patients will be randomized to receive a loading dose of IV methadone, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.~Methadone: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of methadone may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
359956|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359929|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
359930|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
359931|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg/m^2) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
359932|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
359933|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration in Weeks 1 and 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
359934|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
359935|NCT01094548|E2|Reported Event|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
359936|NCT01094548|E1|Reported Event|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
359937|NCT01094522|B3|Baseline|Total|Total of all reporting groups
359938|NCT01094522|B2|Baseline|Morphine|"One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.~Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
360200|NCT01094119|O1|Outcome|Bair Hugger Heated Blanket|"Patients will be warmed during surgery with the Bair Hugger heated blanket.~heated blanket: heated blanket"
359940|NCT01094522|P2|Participant Flow|Morphine|"One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.~Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
359941|NCT01094522|P1|Participant Flow|Methadone|"One half the Study patients will be randomized to receive a loading dose of IV methadone, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.~Methadone: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of methadone may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
359942|NCT01094522|O1|Outcome|Methadone|"One half the Study patients will be randomized to receive a loading dose of IV methadone, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.~Methadone: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of methadone may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
359943|NCT01094522|O2|Outcome|Morphine|"One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.~Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
359944|NCT01094522|O1|Outcome|Methadone|"One half the Study patients will be randomized to receive a loading dose of IV methadone, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.~Methadone: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of methadone may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
359945|NCT01094522|O2|Outcome|Morphine|"One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.~Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
359946|NCT01094522|O1|Outcome|Methadone|"One half the Study patients will be randomized to receive a loading dose of IV methadone, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.~Methadone: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of methadone may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
359947|NCT01094522|O1|Outcome|Morphine|"One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.~Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
359948|NCT01094522|E2|Reported Event|Morphine|"One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.~Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
359949|NCT01094522|E1|Reported Event|Methadone|"One half the Study patients will be randomized to receive a loading dose of IV methadone, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.~Methadone: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of methadone may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
359950|NCT01094184|B3|Baseline|Total|Total of all reporting groups
359951|NCT01094184|B2|Baseline|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359952|NCT01094184|B1|Baseline|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359953|NCT01094184|P2|Participant Flow|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359954|NCT01094184|P1|Participant Flow|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 milligrams per kilogram (mg/kg) every 2 weeks (Q2W) as intravenous infusion along with paclitaxel every week (Q1W) or docetaxel every 3 weeks (Q3W) as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360201|NCT01094119|O2|Outcome|LMA PerfecTemp System|"Patients will be warmed during surgery with the PerfecTemp heated pad .~heated pad: patients will be warmed with a heated pad during surgery."
359957|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359958|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359959|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359960|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359961|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359962|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359963|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359964|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359965|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359966|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359967|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359968|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359969|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359970|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359971|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359972|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359973|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359974|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359975|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359976|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359977|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359978|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359979|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359980|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360202|NCT01094119|O1|Outcome|Bair Hugger Heated Blanket|"Patients will be warmed during surgery with the Bair Hugger heated blanket.~heated blanket: heated blanket"
359981|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359982|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359983|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359984|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359985|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359986|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359987|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359988|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359989|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359990|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359991|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359992|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359993|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359994|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359995|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359996|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359997|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359998|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
359999|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360000|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360001|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360002|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360003|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360004|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360347|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
360005|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360006|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360007|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360008|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360009|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360010|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360011|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360012|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360013|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360014|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360015|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360016|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360017|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360018|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360019|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360020|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360021|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360022|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360023|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360024|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360025|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360026|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360027|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360028|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360348|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360029|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360030|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360031|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360032|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360033|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360034|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360035|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360036|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360037|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360038|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360039|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360040|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360041|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360042|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360043|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360044|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360045|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360046|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360047|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360048|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360049|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360050|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360051|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360052|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360349|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360053|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360054|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360055|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360056|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360057|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360058|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360059|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360060|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360061|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360062|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360063|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360064|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360065|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360066|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360067|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360068|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360069|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360070|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360071|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360072|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360073|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360074|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360075|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360076|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360350|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360077|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360078|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360079|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360080|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360081|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360082|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360083|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360084|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360085|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360086|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360087|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360088|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360089|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360090|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360091|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360092|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360093|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360094|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360095|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360096|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360097|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360098|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360099|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360100|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360351|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
360101|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360102|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360103|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360104|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360105|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360106|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360107|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360108|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360109|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360110|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360111|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360112|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360113|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360114|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360115|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360116|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360117|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360118|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360119|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360120|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360121|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360122|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360123|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360124|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360352|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360125|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360126|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360127|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360128|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360129|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360130|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360131|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360132|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360133|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360134|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360135|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360136|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360137|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360138|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360139|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360140|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360141|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360142|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360143|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360144|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360145|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360146|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360147|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360148|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360353|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360149|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360150|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360151|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360152|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360153|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360154|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360155|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360156|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360157|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360158|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360159|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360160|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360161|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360162|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360163|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360164|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360165|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360166|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360167|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360168|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360169|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360170|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360171|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360172|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360354|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360173|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360174|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360175|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360176|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360177|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360178|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360179|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360180|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360181|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360182|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360183|NCT01094184|O2|Outcome|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360184|NCT01094184|O1|Outcome|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360185|NCT01094184|E2|Reported Event|Bevacizumab 15 mg/kg Q3W|Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360186|NCT01094184|E1|Reported Event|Bevacizumab 10 mg/kg Q2W|Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
360187|NCT01094171|B1|Baseline|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
360188|NCT01094171|P1|Participant Flow|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
360189|NCT01094171|O1|Outcome|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
360190|NCT01094171|O1|Outcome|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
360191|NCT01094171|O1|Outcome|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
360192|NCT01094171|O1|Outcome|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
360193|NCT01094171|E1|Reported Event|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
360194|NCT01094119|B3|Baseline|Total|Total of all reporting groups
360195|NCT01094119|B2|Baseline|LMA PerfecTemp System|"Patients will be warmed during surgery with the PerfecTemp heated pad .~heated pad: patients will be warmed with a heated pad during surgery."
360196|NCT01094119|B1|Baseline|Bair Hugger Heated Blanket|"Patients will be warmed during surgery with the Bair Hugger heated blanket.~heated blanket: heated blanket"
360197|NCT01094119|P2|Participant Flow|LMA PerfecTemp System|"Patients will be warmed during surgery with the PerfecTemp heated pad .~heated pad: patients will be warmed with a heated pad during surgery."
360198|NCT01094119|P1|Participant Flow|Bair Hugger Heated Blanket|"Patients will be warmed during surgery with the Bair Hugger heated blanket.~heated blanket: heated blanket"
360199|NCT01094119|O2|Outcome|LMA PerfecTemp System|"Patients will be warmed during surgery with the PerfecTemp heated pad .~heated pad: patients will be warmed with a heated pad during surgery."
360203|NCT01094119|E2|Reported Event|LMA PerfecTemp System|"Patients will be warmed during surgery with the PerfecTemp heated pad .~heated pad: patients will be warmed with a heated pad during surgery."
360204|NCT01094119|E1|Reported Event|Bair Hugger Heated Blanket|"Patients will be warmed during surgery with the Bair Hugger heated blanket.~heated blanket: heated blanket"
360205|NCT01093976|B1|Baseline|Dronabinol|Dronabinol (Marinol) – 2.5mg–15mg by mouth once a day for twelve-weeks
360206|NCT01093976|P1|Participant Flow|Dronabinol|Dronabinol (Marinol) – 2.5mg–15mg by mouth once a day for twelve-weeks
360207|NCT01093976|O1|Outcome|Dronabinol|Dronabinol (Marinol) - 2.5mg-15mg by mouth once a day for twelve-weeks
360208|NCT01093976|E1|Reported Event|Dronabinol|Dronabinol (Marinol) – 2.5mg–15mg by mouth once a day for twelve-weeks
360209|NCT01093846|B4|Baseline|Total|Total of all reporting groups
360210|NCT01093846|B3|Baseline|AIN457 Placebo|
360211|NCT01093846|B2|Baseline|AIN457 300 mg Monthly|300 mg monthly
360212|NCT01093846|B1|Baseline|AIN457 300 mg Every 2 Weeks|300 mg every two weeks
360213|NCT01093846|P3|Participant Flow|AIN457 Placebo|
360214|NCT01093846|P2|Participant Flow|AIN457 300 mg Monthly|300 mg monthly
360215|NCT01093846|P1|Participant Flow|AIN457 300 mg Every 2 Weeks|300 mg every two weeks
360216|NCT01093846|O1|Outcome|Early Termination|
360217|NCT01093846|E3|Reported Event|Placebo|Placebo Safety is provided over the entire treatment period. This includes the core and extension period.
360218|NCT01093846|E2|Reported Event|AIN457 300mg Monthly|AIN457 300mg monthly Safety is provided over the entire treatment period. This includes the core and extension period.
360219|NCT01093846|E1|Reported Event|AIN457 300mg Every 2 Weeks|AIN457 300mg every 2 weeks. Safety is provided over the entire treatment period. This includes the core and extension period.
360220|NCT01093794|B1|Baseline|All Participants|
360221|NCT01093794|P4|Participant Flow|4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC|"Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:~sitagliptin/metformin 50 mg/850 mg FDC tablet~Co-administration of 50 mg sitagliptin and 500 mg metformin~Co-administration of 50 mg sitagliptin and 850 mg metformin~sitagliptin/metformin 50 mg/500 mg FDC tablet"
360222|NCT01093794|P3|Participant Flow|3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500|"Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:~Co-administration of 50 mg sitagliptin and 850 mg metformin~sitagliptin/metformin 50 mg/850 mg FDC tablet~sitagliptin/metformin 50 mg/500 mg FDC tablet~Co-administration of 50 mg sitagliptin and 500mg metformin"
360223|NCT01093794|P2|Participant Flow|2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC|"Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:~sitagliptin/metformin 50 mg/500 mg FDC tablet~Co-administration of 50 mg sitagliptin and 850 mg metformin~Co-administration of 50 mg sitagliptin and 500mg metformin~sitagliptin/metformin 50 mg/850 mg FDC tablet"
360224|NCT01093794|P1|Participant Flow|1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850|"Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:~Co-administration of 50 mg sitagliptin and 500 mg metformin~sitagliptin/metformin 50 mg/500 mg FDC tablet~sitagliptin/metformin 50 mg/850 mg FDC tablet~Co-administration of 50 mg sitagliptin and 850 mg metformin"
360225|NCT01093794|O4|Outcome|SitMet 50mg/850mg FDC|Participants administered sitagliptin/metformin 50 mg/850 mg FDC tablet from all treatment sequences.
360226|NCT01093794|O3|Outcome|Sit 50 mg + Met 850 mg|Participants co-administered 50 mg sitagliptin and 850mg metformin as individual tablets from all treatment sequences.
360227|NCT01093794|O2|Outcome|SitMet 50mg/500mg FDC|Participants administered the sitagliptin/metformin 50 mg/500 mg FDC tablet from all treatment sequences.
360228|NCT01093794|O1|Outcome|Sit 50 mg + Met 500 mg|Participants co-administered 50 mg sitagliptin and 500 mg metformin as individual tablets from all treatment sequences.
360229|NCT01093794|O4|Outcome|SitMet 50mg/850mg FDC|Participants administered sitagliptin/metformin 50 mg/850 mg FDC tablet from all treatment sequences.
360230|NCT01093794|O3|Outcome|Sit 50 mg + Met 850 mg|Participants co-administered 50 mg sitagliptin and 850mg metformin as individual tablets from all treatment sequences.
360231|NCT01093794|O2|Outcome|SitMet 50mg/500mg FDC|Participants administered the sitagliptin/metformin 50 mg/500 mg FDC tablet from all treatment sequences.
360232|NCT01093794|O1|Outcome|Sit 50 mg + Met 500 mg|Participants co-administered 50 mg sitagliptin and 500 mg metformin as individual tablets from all treatment sequences.
360233|NCT01093794|E4|Reported Event|Sit/Met 50 mg/850 mg FDC|AEs reported in participants after administration of sitagliptin 50 mg/metformin 850 mg FDC tablet.
360234|NCT01093794|E3|Reported Event|Sit 50 mg + Met 850 mg|AEs reported in participants after co-administration of 50 mg sitagliptin and 850 mg metformin.
360235|NCT01093794|E2|Reported Event|Sit/Met 50 mg/500 mg FDC|AEs reported in participants after administration of the sitagliptin/metformin 50 mg/500 mg fixed dose combination (FDC) tablet.
360236|NCT01093794|E1|Reported Event|Sit 50 mg + Met 500 mg|AEs reported in participants after co-administration of 50 mg sitagliptin and 500 mg metformin.
360237|NCT01093755|B3|Baseline|Total|Total of all reporting groups
360238|NCT01093755|B2|Baseline|Omeprazole|"Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.~Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months"
360239|NCT01093755|B1|Baseline|Dexlansoprazole|"Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months~dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months"
360240|NCT01093755|P2|Participant Flow|Omeprazole|"Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.~Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months"
360241|NCT01093755|P1|Participant Flow|Dexlansoprazole|"Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months~dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months"
360242|NCT01093755|O2|Outcome|Omeprazole|"Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.~Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months"
360243|NCT01093755|O1|Outcome|Dexlansoprazole|"Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months~dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months"
360244|NCT01093755|O2|Outcome|Omeprazole|"Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.~Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months"
360245|NCT01093755|O1|Outcome|Dexlansoprazole|"Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months~dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months"
360246|NCT01093755|E2|Reported Event|Omeprazole|"Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.~Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months"
360247|NCT01093755|E1|Reported Event|Dexlansoprazole|"Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months~dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months"
360248|NCT01093690|B3|Baseline|Total|Total of all reporting groups
360249|NCT01093690|B2|Baseline|Placebo|ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5
360250|NCT01093690|B1|Baseline|Metoclopramide|ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5
360251|NCT01093690|P2|Participant Flow|Placebo|ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5
360252|NCT01093690|P1|Participant Flow|Metoclopramide|ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5
360253|NCT01093690|O2|Outcome|Placebo|ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5
360254|NCT01093690|O1|Outcome|Metoclopramide|ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5
360255|NCT01093690|E2|Reported Event|Placebo|ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5
360256|NCT01093690|E1|Reported Event|Metoclopramide|ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5
360257|NCT01093651|B3|Baseline|Total|Total of all reporting groups
360258|NCT01093651|B2|Baseline|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
360259|NCT01093651|B1|Baseline|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
360260|NCT01093651|P2|Participant Flow|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
360261|NCT01093651|P1|Participant Flow|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
360262|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
360263|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
360264|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
360265|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
360266|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
360267|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
360268|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
360269|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
360270|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
360271|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
360272|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
360355|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
360273|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
360274|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
360275|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
360276|NCT01093651|E2|Reported Event|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
360277|NCT01093651|E1|Reported Event|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
360278|NCT01093625|B3|Baseline|Total|Total of all reporting groups
360279|NCT01093625|B2|Baseline|Spectacles|Subjects are randomized to this Control Group.
360280|NCT01093625|B1|Baseline|Investigational Silicone Hydrogel Contact Lens|Subjects randomized to the study arm wearing contact lenses. These subjects are considered neophytes and are non-habitual wearers. Test Group.
360281|NCT01093625|P2|Participant Flow|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
360282|NCT01093625|P1|Participant Flow|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
360283|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
360284|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
360285|NCT01093625|O2|Outcome|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
360286|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
360287|NCT01093625|O2|Outcome|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
360288|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
360289|NCT01093625|O2|Outcome|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
360290|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
360291|NCT01093625|O2|Outcome|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
360292|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
360293|NCT01093625|O2|Outcome|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
360294|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
360295|NCT01093625|O2|Outcome|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
360296|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
360297|NCT01093625|E2|Reported Event|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
360298|NCT01093625|E1|Reported Event|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
360299|NCT01093599|B3|Baseline|Total|Total of all reporting groups
360300|NCT01093599|B2|Baseline|Quit Line Plus MTS|"Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention.~Quit Line plus MTS: This provides the quit line intervention plus the Mindfulness for Smokers Intervention."
360301|NCT01093599|B1|Baseline|Quit Line Only|"Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.~Quit Line Only: The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches."
360302|NCT01093599|P2|Participant Flow|Quit Line Plus MTS|"Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention.~Quit Line plus MTS: This provides the quit line intervention plus the Mindfulness for Smokers Intervention."
360356|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360303|NCT01093599|P1|Participant Flow|Quit Line Only|"Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.~Quit Line Only: The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches."
360304|NCT01093599|O2|Outcome|Quit Line Plus MTS|"Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention.~Quit Line plus MTS: This provides the quit line intervention plus the Mindfulness for Smokers Intervention."
360305|NCT01093599|O1|Outcome|Quit Line Only|"Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.~Quit Line Only: The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches."
360306|NCT01093599|E2|Reported Event|Quit Line Plus MTS|"Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention.~Quit Line plus MTS: This provides the quit line intervention plus the Mindfulness for Smokers Intervention."
360307|NCT01093599|E1|Reported Event|Quit Line Only|"Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.~Quit Line Only: The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches."
360308|NCT01093534|B4|Baseline|Total|Total of all reporting groups
360309|NCT01093534|B3|Baseline|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360310|NCT01093534|B2|Baseline|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360311|NCT01093534|B1|Baseline|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360312|NCT01093534|P3|Participant Flow|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360313|NCT01093534|P2|Participant Flow|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360314|NCT01093534|P1|Participant Flow|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360315|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
360316|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360317|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360318|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360319|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
360320|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360321|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360322|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360323|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
360324|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360325|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360326|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360327|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
360328|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360329|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360330|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360331|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
360332|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360333|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360334|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360335|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
360336|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360337|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360338|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360339|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
360340|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360341|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360342|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360343|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
360344|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360345|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360346|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
363129|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
360357|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360358|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360359|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
360360|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360361|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360362|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360363|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
360364|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360365|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360366|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360367|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
360368|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360369|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360370|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360371|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
360372|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360373|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360374|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360375|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
360376|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360377|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360378|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360379|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
360380|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360381|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360382|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360383|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
360384|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360385|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360386|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360387|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
360388|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360389|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360390|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360391|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
360392|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360393|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360394|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360395|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
360396|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360397|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360398|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360399|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
360400|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360401|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360402|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360403|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
360404|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360405|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360406|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360407|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
360408|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360547|NCT01092780|O4|Outcome|Placebo|Participants received single doses of Placebo.
360409|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360410|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360411|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
360412|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360413|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360414|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360415|NCT01093534|E3|Reported Event|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
360416|NCT01093534|E2|Reported Event|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
360417|NCT01093534|E1|Reported Event|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
360418|NCT01093521|B1|Baseline|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
360419|NCT01093521|P1|Participant Flow|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
360420|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
360421|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
360422|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
360423|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
360424|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
360425|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
360426|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
360427|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
360428|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
360429|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
360430|NCT01093521|O2|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 200 mg/m2/day"
360431|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day"
360432|NCT01093521|E1|Reported Event|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
360433|NCT01093482|B1|Baseline|Mechanically Ventilated Patients|"Patients who are admitted to the participating intensive care units and require invasive mechanical ventilation (endotracheal tube or tracheostomy) for more than 12 hours.~Patients who are admitted to the participating intensive care units and require non-invasive mechanical ventilation (Bilevel positive airway pressure (BIPAP) or continuous positive airway pressure (CPAP) with nasal or facial mask) for more than 1 hour."
360434|NCT01093482|P1|Participant Flow|Mechanically Ventilated Patients|"Patients who are admitted to the participating intensive care units and require invasive mechanical ventilation (endotracheal tube or tracheostomy) for more than 12 hours.~Patients who are admitted to the participating intensive care units and require non-invasive mechanical ventilation (Bilevel positive airway pressure (BIPAP) or continuous positive airway pressure (CPAP) with nasal or facial mask) for more than 1 hour."
360474|NCT01093027|O1|Outcome|15 - 30|The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.
360548|NCT01092780|O3|Outcome|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
360435|NCT01093482|O1|Outcome|Mechanically Ventilated Patients|"Patients who are admitted to the participating intensive care units and require invasive mechanical ventilation (endotracheal tube or tracheostomy) for more than 12 hours.~Patients who are admitted to the participating intensive care units and require non-invasive mechanical ventilation (Bilevel positive airway pressure (BIPAP) or continuous positive airway pressure (CPAP) with nasal or facial mask) for more than 1 hour."
360436|NCT01093482|E1|Reported Event|Mechanically Ventilated Patients|"Patients who are admitted to the participating intensive care units and require invasive mechanical ventilation (endotracheal tube or tracheostomy) for more than 12 hours.~Patients who are admitted to the participating intensive care units and require non-invasive mechanical ventilation (Bilevel positive airway pressure (BIPAP) or continuous positive airway pressure (CPAP) with nasal or facial mask) for more than 1 hour."
360437|NCT01093469|B4|Baseline|Total|Total of all reporting groups
360438|NCT01093469|B3|Baseline|EpiCream Skin Barrier Emulsion|EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis
360439|NCT01093469|B2|Baseline|Atopiclair Nonsteroidal Cream|Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis
360440|NCT01093469|B1|Baseline|Aquaphor Healing Ointment|Aquaphor Healing Ointment three times daily to atopic dermatitis
360441|NCT01093469|P3|Participant Flow|EpiCream Skin Barrier Emulsion|EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis
360442|NCT01093469|P2|Participant Flow|Atopiclair Nonsteroidal Cream|Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis
360443|NCT01093469|P1|Participant Flow|Aquaphor Healing Ointment|Aquaphor Healing Ointment three times daily to atopic dermatitis
360444|NCT01093469|O3|Outcome|EpiCream Skin Barrier Emulsion|EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis
360445|NCT01093469|O2|Outcome|Atopiclair Nonsteroidal Cream|Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis
360446|NCT01093469|O1|Outcome|Aquaphor Healing Ointment|Aquaphor Healing Ointment three times daily to atopic dermatitis
360447|NCT01093469|E3|Reported Event|EpiCream Skin Barrier Emulsion|EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis
360448|NCT01093469|E2|Reported Event|Atopiclair Nonsteroidal Cream|Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis
360449|NCT01093469|E1|Reported Event|Aquaphor Healing Ointment|Aquaphor Healing Ointment three times daily to atopic dermatitis
360450|NCT01093417|B3|Baseline|Total|Total of all reporting groups
360451|NCT01093417|B2|Baseline|Vitamin D 4000 IU|30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
360452|NCT01093417|B1|Baseline|Placebo|15 participants were randomized to matching placebo for 12 weeks
360453|NCT01093417|P2|Participant Flow|Vitamin D 4000 IU|30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
360454|NCT01093417|P1|Participant Flow|Placebo|15 participants were randomized to matching placebo for 12 weeks
360455|NCT01093417|O2|Outcome|Vitamin D 4000 IU|30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
360456|NCT01093417|O1|Outcome|Placebo|15 participants were randomized to matching placebo for 12 weeks
360457|NCT01093417|O2|Outcome|Vitamin D 4000 IU|30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
360458|NCT01093417|O1|Outcome|Placebo|15 participants were randomized to matching placebo for 12 weeks
360459|NCT01093417|E2|Reported Event|Vitamin D 4000 IU|30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
360460|NCT01093417|E1|Reported Event|Placebo|15 participants were randomized to matching placebo for 12 weeks
360461|NCT01093222|B1|Baseline|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
360462|NCT01093222|P1|Participant Flow|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
360463|NCT01093222|O1|Outcome|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
360464|NCT01093222|O1|Outcome|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
360465|NCT01093222|O1|Outcome|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
360466|NCT01093222|O1|Outcome|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
360467|NCT01093222|E1|Reported Event|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
360468|NCT01093027|B3|Baseline|Total|Total of all reporting groups
360469|NCT01093027|B2|Baseline|30 - 15|The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
360470|NCT01093027|B1|Baseline|15 - 30|The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.
360471|NCT01093027|P2|Participant Flow|30 - 15|The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
360472|NCT01093027|P1|Participant Flow|15 - 30|The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.
360473|NCT01093027|O2|Outcome|30 - 15|The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
363130|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
360475|NCT01093027|O2|Outcome|30 - 15|The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
360476|NCT01093027|O1|Outcome|15 - 30|The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.
360477|NCT01093027|E2|Reported Event|30 - 15|The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
360478|NCT01093027|E1|Reported Event|15 - 30|The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.
360479|NCT01093014|B4|Baseline|Total|Total of all reporting groups
360480|NCT01093014|B3|Baseline|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation
360481|NCT01093014|B2|Baseline|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation
360482|NCT01093014|B1|Baseline|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation
360483|NCT01093014|P3|Participant Flow|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation
360484|NCT01093014|P2|Participant Flow|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation
360485|NCT01093014|P1|Participant Flow|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation
360486|NCT01093014|O3|Outcome|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke non-summated, low-force contractions, followed by: 1) a 1-month washout period, then; 2) electrical stimulation to evoke summated, high-force contractions.
360487|NCT01093014|O2|Outcome|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke non-summated, low-force contractions, using either a lab-based system or a portable system for up to 1 year.
360488|NCT01093014|O1|Outcome|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke summated, high-force contractions, using either a lab-based system or a portable system for up to 1 year.
360489|NCT01093014|O3|Outcome|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation
360490|NCT01093014|O2|Outcome|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation
360491|NCT01093014|O1|Outcome|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation
360492|NCT01093014|O3|Outcome|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation
360493|NCT01093014|O2|Outcome|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation
360494|NCT01093014|O1|Outcome|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation
360495|NCT01093014|O3|Outcome|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke non-summated, low-force contractions, followed by: 1) a 1-month washout period, then; 2) electrical stimulation to evoke summated, high-force contractions.
360496|NCT01093014|O2|Outcome|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke non-summated, low-force contractions, using either a lab-based system or a portable system for up to 1 year.
360497|NCT01093014|O1|Outcome|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke summated, high-force contractions, using either a lab-based system or a portable system for up to 1 year.
360498|NCT01093014|E3|Reported Event|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation
360499|NCT01093014|E2|Reported Event|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation
360500|NCT01093014|E1|Reported Event|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation
360501|NCT01092923|B3|Baseline|Total|Total of all reporting groups
360502|NCT01092923|B2|Baseline|Sevoflurane in N2O/O2|Sevoflurane in 2:1 N2O/O2
360503|NCT01092923|B1|Baseline|Air/Oxygen|Sevoflurane with Air/Oxygen Mix
360504|NCT01092923|P2|Participant Flow|Sevoflurane in N2O/O2|Sevoflurane in 2:1 N2O/O2
360505|NCT01092923|P1|Participant Flow|Air/Oxygen|Sevoflurane with Air/Oxygen Mix
360506|NCT01092923|O2|Outcome|Sevoflurane in Air/O2|sevoflurane in air/O2 mix
360507|NCT01092923|O1|Outcome|Sevoflurane in N2O/O2|sevoflurane with N20 and Oxygen in 2:1 mix
360508|NCT01092923|O2|Outcome|Sevoflurane in Air/O2|Air/Oxygen and Sevoflurane
360509|NCT01092923|O1|Outcome|Sevoflurane in N2O/O2|N20 with Oxygen (2:1) and Sevoflurane
360510|NCT01092923|O2|Outcome|Sevoflurane in Air/O2|Air/Oxygen and Sevoflurane
360511|NCT01092923|O1|Outcome|Sevoflurane in N2O/O2|N20 with Oxygen (2:1) and Sevoflurane
360512|NCT01092923|E1|Reported Event|N20 With Oxygen (2:1)|sevoflurane with N20 and Oxygen in 2:1 mix
360513|NCT01092910|B1|Baseline|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
360514|NCT01092910|P1|Participant Flow|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
360515|NCT01092910|O1|Outcome|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
360516|NCT01092910|O1|Outcome|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
360517|NCT01092910|O1|Outcome|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
360518|NCT01092910|O1|Outcome|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
360519|NCT01092910|O1|Outcome|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
360520|NCT01092910|O1|Outcome|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
360521|NCT01092910|O1|Outcome|Esteem Implant|"Subjects implanted with the Esteem Totally Implantable Hearing System~The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
360522|NCT01092910|E1|Reported Event|Esteem Implant|"Subjects implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
360523|NCT01092832|B3|Baseline|Total|Total of all reporting groups
360524|NCT01092832|B2|Baseline|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
360525|NCT01092832|B1|Baseline|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
360526|NCT01092832|P2|Participant Flow|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
360527|NCT01092832|P1|Participant Flow|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) with invasive candidiasis/candidemia (ICC) received a loading dose of voriconazole 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with esophageal candidiasis (EC) received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to oral (PO) therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
360528|NCT01092832|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
360529|NCT01092832|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
360541|NCT01092780|P2|Participant Flow|MK-7288 20mg/MK-7288 10mg/Modafinil/Pbo|Participants received single doses of study drug in the following order: MK-7288 20 mg in Treatment Period 1, MK-7288 10 mg in Treatment Period 2, Modafinil 200 mg in Treatment Period 3 and Placebo in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
360542|NCT01092780|P1|Participant Flow|MK-7288 10mg/Pbo/MK-7288 20mg/Modafinil|Participants received single doses of study drug in the following order: MK-7288 10 mg in Treatment Period 1, Placebo (Pbo) in Treatment Period 2, MK-7288 20 mg in Treatment Period 3 and Modafinil 200 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
360530|NCT01092832|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
360531|NCT01092832|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
360532|NCT01092832|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
360533|NCT01092832|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
360534|NCT01092832|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
360535|NCT01092832|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
360536|NCT01092832|E2|Reported Event|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
360537|NCT01092832|E1|Reported Event|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
360538|NCT01092780|B1|Baseline|All Randomized Participants|All participants who were randomized in the study.
360539|NCT01092780|P4|Participant Flow|Pbo/Modafinil/MK-7288 10 mg/MK-7288 20mg|Participants received single doses of study drug in the following order: Placebo in Treatment Period 1, Modafinil 200 mg in Treatment Period 2, MK-7288 10 mg in Treatment Period 3 and MK-7288 20 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
360540|NCT01092780|P3|Participant Flow|Modafinil/MK-7288 20mg/Pbo/MK-7288 10mg|Participants received single doses of study drug in the following order: Modafinil 200 mg in Treatment Period 1, MK-7288 20 mg in Treatment Period 2, Placebo in Treatment Period 3 and MK-7288 10 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
360543|NCT01092780|O4|Outcome|Placebo|Participants received single doses of Placebo.
360549|NCT01092780|O2|Outcome|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
360550|NCT01092780|O1|Outcome|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
360551|NCT01092780|O4|Outcome|Placebo|Participants received single doses of Placebo.
360552|NCT01092780|O3|Outcome|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
360553|NCT01092780|O2|Outcome|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
360554|NCT01092780|O1|Outcome|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
360555|NCT01092780|O4|Outcome|Placebo|Participants received single doses of Placebo.
360556|NCT01092780|O3|Outcome|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
360557|NCT01092780|O2|Outcome|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
360558|NCT01092780|O1|Outcome|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
360559|NCT01092780|O4|Outcome|Placebo|Participants received single doses of Placebo.
360560|NCT01092780|O3|Outcome|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
360561|NCT01092780|O2|Outcome|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
360562|NCT01092780|O1|Outcome|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
360563|NCT01092780|O4|Outcome|Placebo|Participants received single doses of Placebo.
360564|NCT01092780|O3|Outcome|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
360565|NCT01092780|O2|Outcome|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
360566|NCT01092780|O1|Outcome|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
360567|NCT01092780|E4|Reported Event|Placebo|Participants received single doses of Placebo.
360568|NCT01092780|E3|Reported Event|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
360569|NCT01092780|E2|Reported Event|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
360570|NCT01092780|E1|Reported Event|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
360571|NCT01092767|B1|Baseline|Valiant Thoracic Stent Graft With the Captivia Delivery System|
360572|NCT01092767|P1|Participant Flow|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System : All subjects will be implanted with this device
360573|NCT01092767|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System : All subjects will be implanted with this device
360574|NCT01092767|E1|Reported Event|1. Rescue|Rescue
360575|NCT01092728|B3|Baseline|Total|Total of all reporting groups
360576|NCT01092728|B2|Baseline|Dasatinib + Unresectable|Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
360577|NCT01092728|B1|Baseline|Dasatinib + Completely Resectable|Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
360578|NCT01092728|P2|Participant Flow|Dasatinib + Unresectable|Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
360579|NCT01092728|P1|Participant Flow|Dasatinib + Completely Resectable|Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
360580|NCT01092728|O2|Outcome|Dasatinib + Unresectable|Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
360581|NCT01092728|O1|Outcome|Dasatinib + Completely Resectable|Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
360582|NCT01092728|O2|Outcome|Dasatinib + Unresectable|Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
360583|NCT01092728|O1|Outcome|Dasatinib + Completely Resectable|Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
360584|NCT01092728|E2|Reported Event|Dasatinib + Unresectable|Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
360585|NCT01092728|E1|Reported Event|Dasatinib + Completely Resectable|Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
360586|NCT01092702|B1|Baseline|Varenicline|Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
360587|NCT01092702|P1|Participant Flow|Varenicline|Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
360588|NCT01092702|O1|Outcome|Varenicline|Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
360589|NCT01092702|E1|Reported Event|Varenicline|Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
360590|NCT01092663|B3|Baseline|Total|Total of all reporting groups
360591|NCT01092663|B2|Baseline|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.~Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
360592|NCT01092663|B1|Baseline|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
360593|NCT01092663|P2|Participant Flow|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
360594|NCT01092663|P1|Participant Flow|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
360652|NCT01092559|B1|Baseline|Nitric Oxide Via GeNO Nitrosyl System|Nitric Oxide via GeNO Nitrosyl System
360595|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
360596|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
360597|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
360598|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
360599|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
360600|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
360601|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
360602|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
360603|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
360604|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
360605|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
360606|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
360607|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
360608|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
360609|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
360610|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
360611|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
360612|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
360613|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
360614|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
360615|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
360616|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
360617|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
360618|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
360619|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
360620|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
360621|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
360622|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
360653|NCT01092559|P1|Participant Flow|Nitric Oxide Via GeNO Nitrosyl System|Nitric Oxide generated by the GeNO nitrosyl delivery system : single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.
360623|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
360624|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
360625|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.~Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
360626|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
360627|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.~Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
360628|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
360629|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.~Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
360630|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
360631|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.~Sitagliptin: Subjects were given 100 mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks."
360632|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
360633|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.~Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
360634|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
360635|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.~Sitagliptin: Subjects were given 100mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks."
360636|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
360637|NCT01092663|E2|Reported Event|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.~Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
360638|NCT01092663|E1|Reported Event|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
360639|NCT01092637|B3|Baseline|Total|Total of all reporting groups
360640|NCT01092637|B2|Baseline|Non-cooled|Child was allocated standard intensive care only within 6 hours of birth
360641|NCT01092637|B1|Baseline|Cooled|Child was allocated standard intensive care plus moderate whole body hypothermia treatment within 6 hours of birth
360642|NCT01092637|P2|Participant Flow|Non-cooled|"Child was allocated standard intensive care only within 6 hours of birth. Normothermia was maintained throughout.~Between age 6 yr and 7 yr 3m child and family invited to participate in follow-up study.~Questionnaire data collected from Parent(s) and Teacher(s). Paediatrician and Psychologist visited child in school or at home. Paediatrician neurodevelopmental examination completed and documented on Paediatrician Questionnaire.~Psychologist completed the following tests:~Wechsler Pre-School and Primary Scale of Intelligence Third edition (WPPSI III)~NEPSY II selected sub-tests~Working Memory Test Battery for Children (WMTB-C)~Assessors were blinded to original trial treatment allocation."
360643|NCT01092637|P1|Participant Flow|Cooled|"Child was allocated standard intensive care plus moderate whole body hypothermia treatment within 6 hours of birth. Cooling lasted for 72 hours then gradually rewarmed, after which normothermia was maintained.~Between age 6 yr and 7 yr 3m child and family invited to participate in follow-up study.~Questionnaire data collected from Parent(s) and Teacher(s). Paediatrician and Psychologist visited child in school or at home. Paediatrician neurodevelopmental examination completed and documented on Paediatrician Questionnaire.~Psychologist completed the following tests:~Wechsler Pre-School and Primary Scale of Intelligence Third edition (WPPSI III)~NEPSY II selected sub-tests~Working Memory Test Battery for Children (WMTB-C)~Assessors were blinded to original trial treatment allocation."
360644|NCT01092637|O2|Outcome|Non-cooled|Allocated standard treatment (normothermia) at randomization. See full description in Participant flow section.
360645|NCT01092637|O1|Outcome|Cooled|Allocated cooling treatment at randomization to original trial. See full description in Participant flow section.
360646|NCT01092637|O2|Outcome|Non-cooled|Allocated standard treatment (normothermia) at randomization. See full description in Participant flow section.
360647|NCT01092637|O1|Outcome|Cooled|Allocated cooling treatment at randomization to original trial. See full description in Participant flow section.
360648|NCT01092637|O2|Outcome|Non-cooled|Allocated standard treatment (normothermia) at randomization to original trial. See full description in Participant flow section.
360649|NCT01092637|O1|Outcome|Cooled|Allocated cooling treatment at randomization to original trial. See full description in Participant flow section.
360650|NCT01092637|E2|Reported Event|Non-cooled|Allocated standard treatment (normothermia) at randomization. See full description in Participant flow section.
360651|NCT01092637|E1|Reported Event|Cooled|Allocated cooling treatment at randomization to original trial. See full description in Participant flow section.
360654|NCT01092559|O1|Outcome|Nitric Oxide Via GeNO Nitrosyl System|Nitric Oxide generated by the GeNO nitrosyl delivery system : single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.
360655|NCT01092559|O1|Outcome|Nitric Oxide Via GeNO Nitrosyl System|Nitric Oxide generated by the GeNO nitrosyl delivery system : single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.
360656|NCT01092559|E1|Reported Event|Nitric Oxide Via GeNO Nitrosyl System|Nitric Oxide generated by the GeNO nitrosyl delivery system : single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.
360657|NCT01092546|B1|Baseline|Arm 1-Flutemetamol Injection|[18F]Flutemetamol : All subjects will receive an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
360658|NCT01092546|P1|Participant Flow|Arm 1-Flutemetamol Injection|[18F]Flutemetamol : All subjects received an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
360659|NCT01092546|O1|Outcome|Arm 1-Flutemetamol Injection|[18F]Flutemetamol : All subjects received an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
360660|NCT01092546|O1|Outcome|Arm 1-Flutemetamol Injection|[18F]Flutemetamol : All subjects received an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
360661|NCT01092546|E1|Reported Event|Arm 1-Flutemetamol Injection|[18F]Flutemetamol : All subjects will receive an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
360662|NCT01092507|B3|Baseline|Total|Total of all reporting groups
360663|NCT01092507|B2|Baseline|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
360664|NCT01092507|B1|Baseline|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
360665|NCT01092507|P2|Participant Flow|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
360666|NCT01092507|P1|Participant Flow|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
360667|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
360668|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
360669|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
360670|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
360671|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
360672|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
360673|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
360674|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
360675|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
360676|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
360677|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
360678|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
360679|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
360680|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
360681|NCT01092507|E2|Reported Event|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
360682|NCT01092507|E1|Reported Event|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
360683|NCT01092442|B3|Baseline|Total|Total of all reporting groups
360684|NCT01092442|B2|Baseline|Prospective Patients|Prospective Patients: The patient group that had the CryoValve SG Pulmonary Human Heart Valve implanted after the February 2008 clearance of the valve.
360685|NCT01092442|B1|Baseline|Retrospective Patients|Retrospective Patients: These patients had the CryoValve SG Pulmonary Valve implanted prior to the February 2008 clearance of the valve.
360686|NCT01092442|P2|Participant Flow|Prospective Patients|Prospective Patients: The patient group that had the CryoValve SG Pulmonary Human Heart Valve implanted after the February 2008 clearance of the valve.
360687|NCT01092442|P1|Participant Flow|Retrospective Patients|Retrospective Patients: These patients had the CryoValve SG Pulmonary Valve implanted prior to the February 2008 clearance of the valve.
360688|NCT01092442|O2|Outcome|RVOT Reconstruction Patients|Retrospective and Prospective Patients that had the CryoValve SG Pulmonary Human Heart Valve implanted for RVOT reconstruction procedures
360689|NCT01092442|O1|Outcome|Ross Patients|Retrospective and Prospective Patients that had the CryoValve SG Pulmonary Human Heart Valve implanted as a part of the Ross Procedure
360690|NCT01092442|O4|Outcome|Prospective RVOT|
360691|NCT01092442|O3|Outcome|Retrospective RVOT|
360695|NCT01092442|O3|Outcome|Retrospective Right Ventricular Outflow Tract (RVOT)|
360696|NCT01092442|O2|Outcome|Prospective Ross|
360697|NCT01092442|O1|Outcome|Retrospective Ross|
360698|NCT01092442|E2|Reported Event|RVOT Reconstruction Patients|Retrospective and Prospective Patients that had the CryoValve SG Pulmonary Human Heart Valve implanted for RVOT reconstruction procedures
360699|NCT01092442|E1|Reported Event|Ross Patients|Retrospective and Prospective Patients that had the CryoValve SG Pulmonary Human Heart Valve implanted as a part of the Ross Procedure
360700|NCT01092416|B1|Baseline|ORBIT II Subjects|Subjects enrolled in ORBIT II study.
360701|NCT01092416|P1|Participant Flow|ORBIT II Subjects|Subjects enrolled in ORBIT II study.
360702|NCT01092416|O1|Outcome|OAS Treatment Group|Subjects enrolled in ORBIT II study and in whom the atherectomy device was inserted.
360703|NCT01092416|O1|Outcome|ORBIT II Subjects|Subjects enrolled in ORBIT II study.
360704|NCT01092416|O1|Outcome|ORBIT II Subjects|Subjects enrolled in ORBIT II study
360705|NCT01092416|O1|Outcome|ORBIT II Subjects|Subjects enrolled in ORBIT II study
360706|NCT01092416|O1|Outcome|ORBIT II Subjects|Subjects enrolled in ORBIT II study.
360707|NCT01092416|E2|Reported Event|ORBIT II Subjects - 1 Year Results|Serious Adverse Events reported from 31 Days to 1 Year Post-Procedure for Subjects enrolled in ORBIT II study.
360708|NCT01092416|E1|Reported Event|ORBIT II Subjects - 30 Day Results|Serious Adverse Events reported out to 30 Days Post-Procedure for Subjects enrolled in ORBIT II study.
360709|NCT01092364|B4|Baseline|Total|Total of all reporting groups
360710|NCT01092364|B3|Baseline|Advice Only|Advice only control group.
360711|NCT01092364|B2|Baseline|Personal Counseling Intervention|"Behavioral lifestyle intervention for weight loss, delivered by personal counseling.~Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control."
360712|NCT01092364|B1|Baseline|Cell Phone Intervention|"Behavioral lifestyle intervention for weight loss, delivered by cell phone.~Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control."
360713|NCT01092364|P3|Participant Flow|Advice Only|Advice only control group.
360714|NCT01092364|P2|Participant Flow|Personal Counseling Intervention|"Behavioral lifestyle intervention for weight loss, delivered by personal counseling.~Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control."
360715|NCT01092364|P1|Participant Flow|Cell Phone Intervention|"Behavioral lifestyle intervention for weight loss, delivered by cell phone.~Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control."
360716|NCT01092364|O3|Outcome|Advice Only|Advice only control group.
360717|NCT01092364|O2|Outcome|Personal Counseling Intervention|"Behavioral lifestyle intervention for weight loss, delivered by personal counseling.~Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control."
360718|NCT01092364|O1|Outcome|Cell Phone Intervention|"Behavioral lifestyle intervention for weight loss, delivered by cell phone.~Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control."
360719|NCT01092364|E3|Reported Event|Advice Only|Advice only control group.
360720|NCT01092364|E2|Reported Event|Personal Counseling Intervention|"Behavioral lifestyle intervention for weight loss, delivered by personal counseling.~Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control."
360721|NCT01092364|E1|Reported Event|Cell Phone Intervention|"Behavioral lifestyle intervention for weight loss, delivered by cell phone.~Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control."
360722|NCT01092338|B3|Baseline|Total|Total of all reporting groups
360723|NCT01092338|B2|Baseline|7000IU/d Vitamin D3|
360724|NCT01092338|B1|Baseline|4000IU/d of Vitamin D3|
360725|NCT01092338|P2|Participant Flow|7000IU/d Vitamin D3|
360726|NCT01092338|P1|Participant Flow|4000IU/d of Vitamin D3|
360727|NCT01092338|O2|Outcome|7000IU/d Vitamin D3|
360728|NCT01092338|O1|Outcome|4000IU/d of Vitamin D3|
360729|NCT01092338|O2|Outcome|7000IU/d Vitamin D3|
360730|NCT01092338|O1|Outcome|4000IU/d of Vitamin D3|
360731|NCT01092338|E2|Reported Event|7000IU/d Vitamin D3|
360732|NCT01092338|E1|Reported Event|4000IU/d of Vitamin D3|
360733|NCT01091974|B5|Baseline|Total|Total of all reporting groups
360734|NCT01091974|B4|Baseline|4 - Armodafinil Only|"Armodafinil only~armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)"
360735|NCT01091974|B3|Baseline|3 - Placebo Only|"Placebo only~Placebo Comparator: Placebo for 47 days"
360736|NCT01091974|B2|Baseline|2 - CBT-I + Armodafinil|"CBT-I + Armodafinil~armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
360737|NCT01091974|B1|Baseline|1 - CBT-I + Placebo|"CBT-I and placebo~Placebo Comparator: Placebo for 47 days~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
360738|NCT01091974|P4|Participant Flow|4 - Armodafinil Only|Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
360739|NCT01091974|P3|Participant Flow|3- Placebo Only|Placebo Comparator: Placebo for 47 days
360740|NCT01091974|P2|Participant Flow|2 - CBT-I + Armodafinil|"Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
360741|NCT01091974|P1|Participant Flow|Arm 1 - (CBT-I) + Placebo|"Placebo Comparator: Placebo for 47 days~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
360742|NCT01091974|O4|Outcome|4 - Armodafinil Only|Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
360743|NCT01091974|O3|Outcome|3- Placebo Only|Placebo Comparator: Placebo for 47 days
360816|NCT01091662|E2|Reported Event|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
360744|NCT01091974|O2|Outcome|2 - CBT-I + Armodafinil|"Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
360745|NCT01091974|O1|Outcome|Arm 1 - (CBT-I) + Placebo|"Placebo Comparator: Placebo for 47 days~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
360746|NCT01091974|O4|Outcome|4 - Armodafinil Only|Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
360747|NCT01091974|O3|Outcome|3- Placebo Only|Placebo Comparator: Placebo for 47 days
360748|NCT01091974|O2|Outcome|2 - CBT-I + Armodafinil|"Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
360749|NCT01091974|O1|Outcome|Arm 1 - (CBT-I) + Placebo|"Placebo Comparator: Placebo for 47 days~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
360750|NCT01091974|E4|Reported Event|4 - Armodafinil Only|Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
360751|NCT01091974|E3|Reported Event|3- Placebo Only|Placebo Comparator: Placebo for 47 days
360752|NCT01091974|E2|Reported Event|2 - CBT-I + Armodafinil|"Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
360753|NCT01091974|E1|Reported Event|Arm 1 - (CBT-I) + Placebo|"Placebo Comparator: Placebo for 47 days~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
360754|NCT01091948|B3|Baseline|Total|Total of all reporting groups
360755|NCT01091948|B2|Baseline|GlideScope® Video Laryngoscope|"Subjects will be intubated with the GlideScope® Video Laryngoscope.~GlideScope® Video Laryngoscope: Patients will be intubated with the GlideScope® Video Laryngoscope."
360756|NCT01091948|B1|Baseline|Fiberoptic Intubation|"Subjects will be intubated with the Fiberoptic laryngoscope.~Intubation with Fiberoptic laryngoscope: Subjects will be intubated with the Fiberoptic laryngoscope."
360757|NCT01091948|P2|Participant Flow|GlideScope® Video Laryngoscope|"Subjects will be intubated with the GlideScope® Video Laryngoscope.~GlideScope® Video Laryngoscope: Patients will be intubated with the GlideScope® Video Laryngoscope."
360758|NCT01091948|P1|Participant Flow|Active Comparator: Fiberoptic Intubation|"Subjects will be intubated with the Fiberoptic laryngoscope.~Active Comparator: GlideScope® Video Laryngoscope Subjects will be intubated with the GlideScope® Video Laryngoscope"
360759|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
360760|NCT01091948|O1|Outcome|Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
360761|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
360762|NCT01091948|O1|Outcome|Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
360763|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
360764|NCT01091948|O1|Outcome|Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
360765|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
360766|NCT01091948|O1|Outcome|Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
360767|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
360768|NCT01091948|O1|Outcome|Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
360769|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
360770|NCT01091948|O1|Outcome|Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
360771|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
360772|NCT01091948|O1|Outcome|Active Comparator: Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
360773|NCT01091948|E2|Reported Event|GlideScope® Video Laryngoscope|Subjects will be intubated with the GlideScope® Video Laryngoscope
360774|NCT01091948|E1|Reported Event|Fiberoptic|Subjects will be intubated with the Fiberoptic laryngoscope.
360775|NCT01091675|B1|Baseline|Etoricoxib|"All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg.~Etoricoxib: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks."
360776|NCT01091675|P1|Participant Flow|Etoricoxib|"All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg.~Etoricoxib: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks."
360777|NCT01091675|O1|Outcome|Etoricoxib|"All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg.~Etoricoxib: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks."
360778|NCT01091675|E1|Reported Event|Etoricoxib|"All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg.~Etoricoxib: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks."
360779|NCT01091662|B3|Baseline|Total|Total of all reporting groups
360780|NCT01091662|B2|Baseline|ESL 1600 mg|Subjects randomized to 1600 mg QD of eslicarbazepineacetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
360781|NCT01091662|B1|Baseline|ESL1200 mg|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18..
360817|NCT01091662|E1|Reported Event|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
360782|NCT01091662|P2|Participant Flow|ESL1600 mg|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
360783|NCT01091662|P1|Participant Flow|ESL 1200 mg|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18..
360784|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
360785|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
360786|NCT01091662|O2|Outcome|ESL 1600 mg|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
360787|NCT01091662|O1|Outcome|ESL1200 mg|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
360788|NCT01091662|O2|Outcome|ESL 1600 mg|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
360789|NCT01091662|O1|Outcome|ESL1200 mg|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
360790|NCT01091662|O2|Outcome|ESL 1600 mg|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
360791|NCT01091662|O1|Outcome|ESL1200 mg|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
360792|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
360793|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
360794|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
360795|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
360796|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
360797|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
360798|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
360799|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
360800|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
360801|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
360802|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
360803|NCT01091662|O1|Outcome|ESL 1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
360804|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
360805|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
360806|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
360807|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
360808|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
360809|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
360810|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
360811|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
360812|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
360813|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
360814|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
360815|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
360819|NCT01091519|B2|Baseline|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
360820|NCT01091519|B1|Baseline|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
360821|NCT01091519|P2|Participant Flow|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
360822|NCT01091519|P1|Participant Flow|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
360823|NCT01091519|O2|Outcome|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
360824|NCT01091519|O1|Outcome|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
360825|NCT01091519|O2|Outcome|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
360826|NCT01091519|O1|Outcome|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
360827|NCT01091519|O2|Outcome|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
360828|NCT01091519|O1|Outcome|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
360829|NCT01091519|O2|Outcome|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
360830|NCT01091519|O1|Outcome|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
360831|NCT01091519|E2|Reported Event|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
360832|NCT01091519|E1|Reported Event|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
360833|NCT01091454|B1|Baseline|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
360834|NCT01091454|P1|Participant Flow|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
360835|NCT01091454|O1|Outcome|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
360873|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
360836|NCT01091454|O1|Outcome|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
360837|NCT01091454|O1|Outcome|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
360838|NCT01091454|O1|Outcome|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
360839|NCT01091454|O1|Outcome|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
360840|NCT01091454|O1|Outcome|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
360841|NCT01091454|E1|Reported Event|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
360842|NCT01091259|B1|Baseline|Irinotecan With Bevacizumab|"Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.~Irinotecan~Bevacizumab"
360843|NCT01091259|P1|Participant Flow|Irinotecan With Bevacizumab|"Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.~Irinotecan~Bevacizumab"
360844|NCT01091259|O1|Outcome|Irinotecan With Bevacizumab|Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
360845|NCT01091259|O1|Outcome|Irinotecan With Bevacizumab|Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
360846|NCT01091259|O1|Outcome|Irinotecan With Bevacizumab|Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
360847|NCT01091259|O1|Outcome|Irinotecan With Bevacizumab|Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
360848|NCT01091259|O1|Outcome|Irinotecan With Bevacizumab|Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
360849|NCT01091259|E1|Reported Event|Irinotecan With Bevacizumab|Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
360850|NCT01091246|B4|Baseline|Total|Total of all reporting groups
360851|NCT01091246|B3|Baseline|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
360852|NCT01091246|B2|Baseline|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
360853|NCT01091246|B1|Baseline|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360854|NCT01091246|P3|Participant Flow|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
360981|NCT01091116|O3|Outcome|High Dose|two doses
360982|NCT01091116|O2|Outcome|Mid Dose|two doses
360855|NCT01091246|P2|Participant Flow|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
360856|NCT01091246|P1|Participant Flow|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360857|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
360858|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360859|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
360860|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360861|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
360862|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360863|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
360864|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360865|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
360866|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360867|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
360868|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360869|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
360870|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360871|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
360872|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360983|NCT01091116|O1|Outcome|Low Dose|two doses
360874|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360875|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
360876|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360877|NCT01091246|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
360878|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360879|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
360880|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360881|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
360882|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360883|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
360884|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360885|NCT01091246|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
360886|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360887|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
360888|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360889|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
360890|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360891|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
360892|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360893|NCT01091246|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
360894|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360895|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
360896|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360897|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
360898|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360899|NCT01091246|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
360900|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360901|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
360902|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360903|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
360904|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360905|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
360906|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360907|NCT01091246|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
360908|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360909|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
360910|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360911|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
360912|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360913|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
360914|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360915|NCT01091246|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
360916|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360917|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
360918|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360919|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
360920|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360921|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
360922|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360923|NCT01091246|O4|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
360924|NCT01091246|O3|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
360925|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
360926|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360927|NCT01091246|E2|Reported Event|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
360928|NCT01091246|E1|Reported Event|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
360929|NCT01091155|B1|Baseline|ColonRing TM|ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis
360930|NCT01091155|P1|Participant Flow|ColonRing TM|ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis
360931|NCT01091155|O1|Outcome|ColonRing TM|ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis
360932|NCT01091155|E1|Reported Event|ColonRing TM|ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis
360933|NCT01091116|B6|Baseline|Total|Total of all reporting groups
360934|NCT01091116|B5|Baseline|Placebo|two doses
360935|NCT01091116|B4|Baseline|Single High Dose|one dose+placebo
360936|NCT01091116|B3|Baseline|High Dose|two doses
360937|NCT01091116|B2|Baseline|Mid Dose|two doses
360938|NCT01091116|B1|Baseline|Low Dose|two doses
360939|NCT01091116|P5|Participant Flow|Placebo|two intra-articular placebo doses
360940|NCT01091116|P4|Participant Flow|Single High Dose|one intra-articular fasitibant dose 0.5 mg +placebo
360941|NCT01091116|P3|Participant Flow|High Dose|two intra-articular fasitibant doses; 0.5 mg each
360942|NCT01091116|P2|Participant Flow|Mid Dose|two intra-articular fasitibant doses; 0.25 mg each
360943|NCT01091116|P1|Participant Flow|Low Dose|two intra-articular fasitibant doses; 0.125 mg each
360944|NCT01091116|O5|Outcome|Placebo|two doses
360945|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
360946|NCT01091116|O3|Outcome|High Dose|two doses
360947|NCT01091116|O2|Outcome|Mid Dose|two doses
360948|NCT01091116|O1|Outcome|Low Dose|two doses
360949|NCT01091116|O5|Outcome|Placebo|two doses
360950|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
360951|NCT01091116|O3|Outcome|High Dose|two doses
360952|NCT01091116|O2|Outcome|Mid Dose|two doses
360953|NCT01091116|O1|Outcome|Low Dose|two doses
360954|NCT01091116|O5|Outcome|Placebo|two doses
360955|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
360956|NCT01091116|O3|Outcome|High Dose|two doses
360957|NCT01091116|O2|Outcome|Mid Dose|two doses
360958|NCT01091116|O1|Outcome|Low Dose|two doses
360959|NCT01091116|O5|Outcome|Placebo|two doses
360960|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
360961|NCT01091116|O3|Outcome|High Dose|two doses
360962|NCT01091116|O2|Outcome|Mid Dose|two doses
360963|NCT01091116|O1|Outcome|Low Dose|two doses
360964|NCT01091116|O5|Outcome|Placebo|two doses
360965|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
360966|NCT01091116|O3|Outcome|High Dose|two doses
360967|NCT01091116|O2|Outcome|Mid Dose|two doses
360968|NCT01091116|O1|Outcome|Low Dose|two doses
360969|NCT01091116|O5|Outcome|Placebo|two doses
360970|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
360971|NCT01091116|O3|Outcome|High Dose|two doses
360972|NCT01091116|O2|Outcome|Mid Dose|two doses
360973|NCT01091116|O1|Outcome|Low Dose|two doses
360974|NCT01091116|O5|Outcome|Placebo|two doses
360975|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
360976|NCT01091116|O3|Outcome|High Dose|two doses
360977|NCT01091116|O2|Outcome|Mid Dose|two doses
360978|NCT01091116|O1|Outcome|Low Dose|two doses
360979|NCT01091116|O5|Outcome|Placebo|two doses
360980|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
360994|NCT01091103|B1|Baseline|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
360995|NCT01091103|P1|Participant Flow|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
360996|NCT01091103|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
360997|NCT01091103|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
360998|NCT01091103|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
360999|NCT01091103|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
361000|NCT01091103|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
361001|NCT01091103|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
361002|NCT01091103|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
361003|NCT01091103|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
361004|NCT01091103|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
361005|NCT01091103|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
361006|NCT01091103|O2|Outcome|Enzalutamide, PSA Non-Responders at Week 9|PSA non-responders are defined by a less than 50% reduction from baseline in PSA at Week 9
361007|NCT01091103|O1|Outcome|Enzalutamide, PSA Responders at Week 9|PSA responders are defined by a greater than or equal to 50% reduction from baseline in PSA at Week 9
361008|NCT01091103|O2|Outcome|Enzalutamide, PSA Non-Responders at Week 9|PSA non-responders are defined by a less than 50% reduction from baseline in PSA at Week 9
361009|NCT01091103|O1|Outcome|Enzalutamide, PSA Responders at Week 9|PSA responders are defined by a greater than or equal to 50% reduction from baseline in PSA at Week 9
361010|NCT01091103|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
361011|NCT01091103|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
361012|NCT01091103|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
361013|NCT01091103|E1|Reported Event|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
361014|NCT01090973|B1|Baseline|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
361015|NCT01090973|P1|Participant Flow|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
361016|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
361017|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
361018|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
361019|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
361020|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
361021|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
361022|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
361023|NCT01090973|E1|Reported Event|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
361024|NCT01090765|B7|Baseline|Total|Total of all reporting groups
361025|NCT01090765|B6|Baseline|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
361026|NCT01090765|B5|Baseline|TRC105 15 mg/kg Every 2 Weeks|Intravenous infusion at 15 mg/kg every 2 weeks
361027|NCT01090765|B4|Baseline|TRC105 10 mg/kg Weekly|Intravenous infusion at 10 mg/kg weekly
361028|NCT01090765|B3|Baseline|TRC105 10 mg/kg Every 2 Weeks|Intravenous infusion at 10 mg/kg every 2 weeks
361029|NCT01090765|B2|Baseline|TRC105 3 mg/kg Every 2 Weeks|Intravenous infusion at 3 mg/kg every 2 weeks
361030|NCT01090765|B1|Baseline|TRC105 1 mg/kg Every 2 Weeks|Intravenous infusion at 1 mg/kg every 2 weeks
361031|NCT01090765|P6|Participant Flow|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
361032|NCT01090765|P5|Participant Flow|TRC105 15 mg/kg Every 2 Weeks|Intravenous infusion at 15 mg/kg every 2 weeks
361033|NCT01090765|P4|Participant Flow|TRC105 10 mg/kg Weekly|Intravenous infusion at 10 mg/kg weekly
361034|NCT01090765|P3|Participant Flow|TRC105 10 mg/kg Every 2 Weeks|Intravenous infusion at 10 mg/kg every 2 weeks
361035|NCT01090765|P2|Participant Flow|TRC105 3 mg/kg Every 2 Weeks|Intravenous infusion at 3 mg/kg every 2 weeks
361036|NCT01090765|P1|Participant Flow|TRC105 1 mg/kg Every 2 Weeks|Intravenous infusion at 1 mg/kg every 2 weeks
361037|NCT01090765|O6|Outcome|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
361038|NCT01090765|O5|Outcome|TRC105 15 mg/kg Every 2 Weeks|Intravenous infusion at 15 mg/kg every 2 weeks
361039|NCT01090765|O4|Outcome|TRC105 10 mg/kg Weekly|Intravenous infusion at 10 mg/kg weekly
361040|NCT01090765|O3|Outcome|TRC105 10 mg/kg Every 2 Weeks|Intravenous infusion at 10 mg/kg every 2 weeks
361041|NCT01090765|O2|Outcome|TRC105 3 mg/kg Every 2 Weeks|Intravenous infusion at 3 mg/kg every 2 weeks
361042|NCT01090765|O1|Outcome|TRC105 1 mg/kg Every 2 Weeks|Intravenous infusion at 1 mg/kg every 2 weeks
361043|NCT01090765|O6|Outcome|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
361044|NCT01090765|O5|Outcome|TRC105 15 mg/kg Every 2 Weeks|Intravenous infusion at 15 mg/kg every 2 weeks
361045|NCT01090765|O4|Outcome|TRC105 10 mg/kg Weekly|Intravenous infusion at 10 mg/kg weekly
361046|NCT01090765|O3|Outcome|TRC105 10 mg/kg Every 2 Weeks|Intravenous infusion at 10 mg/kg every 2 weeks
361047|NCT01090765|O2|Outcome|TRC105 3 mg/kg Every 2 Weeks|Intravenous infusion at 3 mg/kg every 2 weeks
361048|NCT01090765|O1|Outcome|TRC105 1 mg/kg Every 2 Weeks|Intravenous infusion at 1 mg/kg every 2 weeks
361049|NCT01090765|O6|Outcome|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
361050|NCT01090765|O5|Outcome|TRC105 15 mg/kg Every 2 Weeks|Intravenous infusion at 15 mg/kg every 2 weeks
361051|NCT01090765|O4|Outcome|TRC105 10 mg/kg Weekly|Intravenous infusion at 10 mg/kg weekly
361052|NCT01090765|O3|Outcome|TRC105 10 mg/kg Every 2 Weeks|Intravenous infusion at 10 mg/kg every 2 weeks
361053|NCT01090765|O2|Outcome|TRC105 3 mg/kg Every 2 Weeks|Intravenous infusion at 3 mg/kg every 2 weeks
361054|NCT01090765|O1|Outcome|TRC105 1 mg/kg Every 2 Weeks|Intravenous infusion at 1 mg/kg every 2 weeks
361055|NCT01090765|O6|Outcome|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
361056|NCT01090765|O5|Outcome|TRC105 15 mg/kg Every 2 Weeks|Intravenous infusion at 15 mg/kg every 2 weeks
361057|NCT01090765|O4|Outcome|TRC105 10 mg/kg Weekly|Intravenous infusion at 10 mg/kg weekly
361058|NCT01090765|O3|Outcome|TRC105 10 mg/kg Every 2 Weeks|Intravenous infusion at 10 mg/kg every 2 weeks
361059|NCT01090765|O2|Outcome|TRC105 3 mg/kg Every 2 Weeks|Intravenous infusion at 3 mg/kg every 2 weeks
361060|NCT01090765|O1|Outcome|TRC105 1 mg/kg Every 2 Weeks|Intravenous infusion at 1 mg/kg every 2 weeks
361061|NCT01090765|O1|Outcome|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
361062|NCT01090765|E6|Reported Event|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
361063|NCT01090765|E5|Reported Event|TRC105 15 mg/kg Every 2 Weeks|Intravenous infusion at 15 mg/kg every 2 weeks
361064|NCT01090765|E4|Reported Event|TRC105 10 mg/kg Weekly|Intravenous infusion at 10 mg/kg weekly
361065|NCT01090765|E3|Reported Event|TRC105 10 mg/kg Every 2 Weeks|Intravenous infusion at 10 mg/kg every 2 weeks
361066|NCT01090765|E2|Reported Event|TRC105 3 mg/kg Every 2 Weeks|Intravenous infusion at 3 mg/kg every 2 weeks
361067|NCT01090765|E1|Reported Event|TRC105 1 mg/kg Every 2 Weeks|Intravenous infusion at 1 mg/kg every 2 weeks
361068|NCT01090752|B3|Baseline|Total|Total of all reporting groups
361069|NCT01090752|B2|Baseline|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
361070|NCT01090752|B1|Baseline|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
361071|NCT01090752|P2|Participant Flow|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
361072|NCT01090752|P1|Participant Flow|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
361073|NCT01090752|O2|Outcome|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
361074|NCT01090752|O1|Outcome|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
361075|NCT01090752|O2|Outcome|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
361076|NCT01090752|O1|Outcome|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
361077|NCT01090752|O2|Outcome|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
361078|NCT01090752|O1|Outcome|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
361079|NCT01090752|E2|Reported Event|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
361080|NCT01090752|E1|Reported Event|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
361081|NCT01090739|B1|Baseline|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
361082|NCT01090739|P1|Participant Flow|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
361083|NCT01090739|O1|Outcome|TOPAS|"TOPAS Treatment for Fecal Incontinence~TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh."
361084|NCT01090739|O1|Outcome|TOPAS|"TOPAS Treatment for Fecal Incontinence~TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh."
361085|NCT01090739|O1|Outcome|TOPAS|"TOPAS Treatment for Fecal Incontinence~TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh."
361086|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
361087|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
361088|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
361089|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
361090|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
361091|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
361092|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
361093|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
361094|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
361095|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
361096|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
361097|NCT01090739|E1|Reported Event|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
361098|NCT01090492|B9|Baseline|Total|Total of all reporting groups
361099|NCT01090492|B8|Baseline|SRP Cohort: PF-00489791 20 mg First, Then Placebo|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
361100|NCT01090492|B7|Baseline|SRP Cohort: Placebo First, Then PF-00489791 20 mg|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
361101|NCT01090492|B6|Baseline|SRP Cohort: PF-00489791 4 mg First, Then Placebo|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
361102|NCT01090492|B5|Baseline|SRP Cohort: Placebo First, Then PF-00489791 4 mg|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 4 milligram (mg) (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
361103|NCT01090492|B4|Baseline|PRP Cohort: PF-00489791 20 mg First, Then Placebo|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
361104|NCT01090492|B3|Baseline|PRP Cohort: Placebo First, Then PF-00489791 20 mg|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in second DB intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
361105|NCT01090492|B2|Baseline|PRP Cohort: PF-00489791 4mg First, Then Placebo|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first intervention DB period and 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second DB intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
361295|NCT01090310|O1|Outcome|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
361106|NCT01090492|B1|Baseline|PRP Cohort: Placebo First, Then PF-00489791 4 mg|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 4 milligram (mg) (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
361107|NCT01090492|P8|Participant Flow|SRP Cohort: PF-00489791 20 mg First, Then Placebo|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
361108|NCT01090492|P7|Participant Flow|SRP Cohort: Placebo First, Then PF-00489791 20 mg|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
361109|NCT01090492|P6|Participant Flow|SRP Cohort: PF-00489791 4 mg First, Then Placebo|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
361110|NCT01090492|P5|Participant Flow|SRP Cohort: Placebo First, Then PF-00489791 4 mg|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 4 milligram (mg) (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
361111|NCT01090492|P4|Participant Flow|PRP Cohort: PF-00489791 20 mg First, Then Placebo|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
361112|NCT01090492|P3|Participant Flow|PRP Cohort: Placebo First, Then PF-00489791 20 mg|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
361113|NCT01090492|P2|Participant Flow|PRP Cohort: PF-00489791 4mg First, Then Placebo|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
361114|NCT01090492|P1|Participant Flow|PRP Cohort: Placebo First, Then PF-00489791 4 mg|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 4 milligram (mg) (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
361115|NCT01090492|O6|Outcome|Placebo (SRP)|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361116|NCT01090492|O5|Outcome|PF-00489791 20 mg (SRP)|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361117|NCT01090492|O4|Outcome|PF-00489791 4 mg (SRP)|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361118|NCT01090492|O3|Outcome|Placebo (PRP)|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
361119|NCT01090492|O2|Outcome|PF-00489791 20 mg (PRP)|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
361120|NCT01090492|O1|Outcome|PF-00489791 4 mg (PRP)|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
361121|NCT01090492|O6|Outcome|Placebo (SRP)|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361122|NCT01090492|O5|Outcome|PF-00489791 20 mg (SRP)|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361123|NCT01090492|O4|Outcome|PF-00489791 4 mg (SRP)|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361124|NCT01090492|O3|Outcome|Placebo (PRP)|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
361125|NCT01090492|O2|Outcome|PF-00489791 20 mg (PRP)|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
361126|NCT01090492|O1|Outcome|PF-00489791 4 mg (PRP)|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
361127|NCT01090492|O6|Outcome|Placebo (SRP)|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361128|NCT01090492|O5|Outcome|PF-00489791 20 mg (SRP)|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361129|NCT01090492|O4|Outcome|PF-00489791 4 mg (SRP)|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361130|NCT01090492|O3|Outcome|Placebo (PRP)|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
361131|NCT01090492|O2|Outcome|PF-00489791 20 mg (PRP)|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
361132|NCT01090492|O1|Outcome|PF-00489791 4 mg (PRP)|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
361133|NCT01090492|O4|Outcome|PF-00489791 20 mg (SRP)|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361134|NCT01090492|O3|Outcome|PF-00489791 4 mg (SRP)|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361135|NCT01090492|O2|Outcome|PF-00489791 20 mg (PRP)|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
361136|NCT01090492|O1|Outcome|PF-00489791 4 mg (PRP)|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
361137|NCT01090492|O3|Outcome|Placebo (SRP)|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361138|NCT01090492|O2|Outcome|PF-00489791 20 mg (SRP)|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361139|NCT01090492|O1|Outcome|PF-00489791 4 mg (SRP)|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361140|NCT01090492|O6|Outcome|Placebo (SRP)|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361141|NCT01090492|O5|Outcome|PF-00489791 20 mg (SRP)|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361142|NCT01090492|O4|Outcome|PF-00489791 4 mg (SRP)|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361143|NCT01090492|O3|Outcome|Placebo (PRP)|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
361144|NCT01090492|O2|Outcome|PF-00489791 20 mg (PRP)|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
361145|NCT01090492|O1|Outcome|PF-00489791 4 mg (PRP)|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
361146|NCT01090492|O6|Outcome|Placebo (SRP)|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361147|NCT01090492|O5|Outcome|PF-00489791 20 mg (SRP)|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361148|NCT01090492|O4|Outcome|PF-00489791 4 mg (SRP)|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361149|NCT01090492|O3|Outcome|Placebo (PRP)|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
361150|NCT01090492|O2|Outcome|PF-00489791 20 mg (PRP)|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
361151|NCT01090492|O1|Outcome|PF-00489791 4 mg (PRP)|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
361152|NCT01090492|O6|Outcome|Placebo (SRP)|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361153|NCT01090492|O5|Outcome|PF-00489791 20 mg (SRP)|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361154|NCT01090492|O4|Outcome|PF-00489791 4 mg (SRP)|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361155|NCT01090492|O3|Outcome|Placebo (PRP)|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
361156|NCT01090492|O2|Outcome|PF-00489791 20 mg (PRP)|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
361157|NCT01090492|O1|Outcome|PF-00489791 4 mg (PRP)|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
361158|NCT01090492|O6|Outcome|Placebo (SRP)|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361159|NCT01090492|O5|Outcome|PF-00489791 20 mg (SRP)|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361160|NCT01090492|O4|Outcome|PF-00489791 4 mg (SRP)|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361161|NCT01090492|O3|Outcome|Placebo (PRP)|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
361162|NCT01090492|O2|Outcome|PF-00489791 20 mg (PRP)|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
361296|NCT01090310|O4|Outcome|Placebo|Placebo s.c. every 2 weeks
363150|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
361163|NCT01090492|O1|Outcome|PF-00489791 4 mg (PRP)|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
361164|NCT01090492|E6|Reported Event|Placebo (SRP)|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361165|NCT01090492|E5|Reported Event|PF-00489791 20 mg (SRP)|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361166|NCT01090492|E4|Reported Event|PF-00489791 4 mg (SRP)|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
361167|NCT01090492|E3|Reported Event|Placebo (PRP)|Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
361168|NCT01090492|E2|Reported Event|PF-00489791 20 mg (PRP)|PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
361169|NCT01090492|E1|Reported Event|PF-00489791 4 mg (PRP)|PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
361170|NCT01090479|B3|Baseline|Total|Total of all reporting groups
361171|NCT01090479|B2|Baseline|2% Chlorhexidine Cloth|This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date.
361172|NCT01090479|B1|Baseline|Control|This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date.
361173|NCT01090479|P2|Participant Flow|2% Chlorhexidine Cloth|This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date.
361174|NCT01090479|P1|Participant Flow|Control|This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date.
361175|NCT01090479|O2|Outcome|Chlorhexidine|
361176|NCT01090479|O1|Outcome|Control|
361177|NCT01090479|E2|Reported Event|2% Chlorhexidine Cloth|This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date.
361178|NCT01090479|E1|Reported Event|Control|This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date.
361179|NCT01090453|B3|Baseline|Total|Total of all reporting groups
361180|NCT01090453|B2|Baseline|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361181|NCT01090453|B1|Baseline|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361182|NCT01090453|P2|Participant Flow|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361183|NCT01090453|P1|Participant Flow|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361184|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361185|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361186|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361187|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361230|NCT01090427|P7|Participant Flow|Ustekinumab Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Ustekinumab Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage q12wk with last dose at Week 40.
361188|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361189|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361190|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361191|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361192|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361193|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361194|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361195|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361196|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361197|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361198|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361199|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361200|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361231|NCT01090427|P6|Participant Flow|Ustekinumab Half-Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Ustekinumab Half-Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage q12wk with the last dose at Week 40.
361297|NCT01090310|O3|Outcome|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
361201|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361202|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361203|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361204|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361205|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361206|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361207|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361208|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361209|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361210|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361211|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361212|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361213|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361232|NCT01090427|P5|Participant Flow|Placebo -> Ustekinumab Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage at Week 12 and 16 then q12wk with last dose at Week 40.
361233|NCT01090427|P4|Participant Flow|Placebo -> Ustekinumab Half-Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage at Week 12 and 16 then q12w with the last dose at Week 40.
361214|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361215|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361216|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361217|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361218|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361219|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361220|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361221|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361222|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361223|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361224|NCT01090453|E2|Reported Event|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361225|NCT01090453|E1|Reported Event|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
361226|NCT01090427|B4|Baseline|Total|Total of all reporting groups
361227|NCT01090427|B3|Baseline|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
361228|NCT01090427|B2|Baseline|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
361229|NCT01090427|B1|Baseline|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
361234|NCT01090427|P3|Participant Flow|Ustekinumab Standard Dosage (CP)|Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.75 mg/kg for participants with weight <= 60kg, 45 mg for participants with weight > 60 to <= 100kg, and 90 mg for participants with weight > 100kg.
361235|NCT01090427|P2|Participant Flow|Ustekinumab Half-Standard Dosage (CP)|Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.375 mg/kg for participants with weight <= 60kg, 22.5 mg for participants with weight > 60 to <= 100kg, and 45 mg for participants with weight > 100kg.
361236|NCT01090427|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo Subcutaneous (SC) injections at Week 0 and 4.
361237|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
361238|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
361239|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
361240|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
361241|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
361242|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
361243|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
361244|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
361245|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
361246|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
361247|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
361248|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
361249|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
361250|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
361251|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
361252|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
361253|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
361254|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
361255|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
361256|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
361257|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
361294|NCT01090310|O2|Outcome|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
361258|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
361259|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
361260|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
361261|NCT01090427|E7|Reported Event|Ustekinumab Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Ustekinumab Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage q12wk with last dose at Week 40.
361262|NCT01090427|E6|Reported Event|Ustekinumab Half-Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Ustekinumab Half-Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage q12wk with the last dose at Week 40.
361263|NCT01090427|E5|Reported Event|Placebo -> Ustekinumab Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage at Week 12 and 16 then q12wk with last dose at Week 40.
361264|NCT01090427|E4|Reported Event|Placebo -> Ustekinumab Half-Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage at Week 12 and 16 then q12w with the last dose at Week 40.
361265|NCT01090427|E3|Reported Event|Ustekinumab Standard Dosage (CP)|Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.75 mg/kg for participants with weight <= 60kg, 45 mg for participants with weight > 60 to <= 100kg, and 90 mg for participants with weight > 100kg.
361266|NCT01090427|E2|Reported Event|Ustekinumab Half-Standard Dosage (CP)|Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.375 mg/kg for participants with weight <= 60kg, 22.5 mg for participants with weight > 60 to <= 100kg, and 45 mg for participants with weight > 100kg.
361267|NCT01090427|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo Subcutaneous (SC) injections at Week 0 and 4.
361268|NCT01090323|B3|Baseline|Total|Total of all reporting groups
361269|NCT01090323|B2|Baseline|Crossover|Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
361270|NCT01090323|B1|Baseline|ICL670|Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
361271|NCT01090323|P2|Participant Flow|Crossover|Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
361272|NCT01090323|P1|Participant Flow|ICL670|Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
361273|NCT01090323|O2|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
361274|NCT01090323|O1|Outcome|ICL670|Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
361275|NCT01090323|O2|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
361276|NCT01090323|O1|Outcome|ICL670|Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
361277|NCT01090323|E2|Reported Event|Crossover|Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
361278|NCT01090323|E1|Reported Event|ICL670|Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
361279|NCT01090310|B5|Baseline|Total|Total of all reporting groups
361280|NCT01090310|B4|Baseline|Placebo|Placebo s.c. every 2 weeks
361281|NCT01090310|B3|Baseline|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
361282|NCT01090310|B2|Baseline|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
361283|NCT01090310|B1|Baseline|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
361284|NCT01090310|P4|Participant Flow|Placebo|Placebo s.c. every 2 weeks
361285|NCT01090310|P3|Participant Flow|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
361286|NCT01090310|P2|Participant Flow|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
361287|NCT01090310|P1|Participant Flow|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
361288|NCT01090310|O4|Outcome|Placebo|Placebo s.c. every 2 weeks
361289|NCT01090310|O3|Outcome|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
361290|NCT01090310|O2|Outcome|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
361291|NCT01090310|O1|Outcome|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
361292|NCT01090310|O4|Outcome|Placebo|Placebo s.c. every 2 weeks
361293|NCT01090310|O3|Outcome|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
363151|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
361298|NCT01090310|O2|Outcome|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
361299|NCT01090310|O1|Outcome|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
361300|NCT01090310|O4|Outcome|Placebo|Placebo s.c. every 2 weeks
361301|NCT01090310|O3|Outcome|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
361302|NCT01090310|O2|Outcome|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
361303|NCT01090310|O1|Outcome|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
361304|NCT01090310|O4|Outcome|Placebo|Placebo s.c. every 2 weeks
361305|NCT01090310|O3|Outcome|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
361306|NCT01090310|O2|Outcome|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
361307|NCT01090310|O1|Outcome|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
361308|NCT01090310|E4|Reported Event|Placebo Every 2 Weeks|Placebo every 2 weeks
361309|NCT01090310|E3|Reported Event|AIN457 150mg Every 4 Weeks|AIN457 150mg every 4 weeks
361310|NCT01090310|E2|Reported Event|AIN457 300mg Every 4 Weeks|AIN457 300mg every 4 weeks
361311|NCT01090310|E1|Reported Event|AIN457 300mg Every 2 Weeks|AIN457 300mg every 2 weeks
361312|NCT01090180|B3|Baseline|Total|Total of all reporting groups
361313|NCT01090180|B2|Baseline|Arm 2: Placebo|Placebo (sugar pill): inactive
361314|NCT01090180|B1|Baseline|Arm 1: Dexamethasone|Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
361315|NCT01090180|P2|Participant Flow|Arm 2: Placebo|Placebo (sugar pill): inactive
361316|NCT01090180|P1|Participant Flow|Arm 1: Dexamethasone|Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
361317|NCT01090180|O2|Outcome|Arm 2: Placebo|Placebo (sugar pill): inactive
361318|NCT01090180|O1|Outcome|Arm 1: Dexamethasone|Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
361319|NCT01090180|O2|Outcome|Arm 2: Placebo|Placebo (sugar pill): inactive
361320|NCT01090180|O1|Outcome|Arm 1: Dexamethasone|Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
361321|NCT01090180|E2|Reported Event|Arm 2: Placebo|Placebo (sugar pill): inactive
361322|NCT01090180|E1|Reported Event|Arm 1: Dexamethasone|Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
361323|NCT01090102|B3|Baseline|Total|Total of all reporting groups
361324|NCT01090102|B2|Baseline|Placebo Then Mesalamine|Placebo: Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth), followed by Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
361325|NCT01090102|B1|Baseline|Mesalamine Then Placebo|Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth), followed by Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
361326|NCT01090102|P2|Participant Flow|Placebo Then Mesalamine|Placebo: Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth), followed by Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
361327|NCT01090102|P1|Participant Flow|Mesalamine Then Placebo|Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth), followed by Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
361328|NCT01090102|O2|Outcome|Placebo Then Mesalamine|Placebo: Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth), followed by Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
361329|NCT01090102|O1|Outcome|Mesalamine Then Placebo|Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth), followed by Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
361330|NCT01090102|O2|Outcome|Placebo Then Mesalamine|Placebo: Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth), followed by Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
361331|NCT01090102|O1|Outcome|Mesalamine Then Placebo|Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth), followed by Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
361332|NCT01090102|E2|Reported Event|Placebo|Placebo: Four placebo capsules once daily (1.5g/d) PO (by mouth).
361333|NCT01090102|E1|Reported Event|Mesalamine|Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) PO(by mouth).
361334|NCT01090076|B3|Baseline|Total|Total of all reporting groups
361335|NCT01090076|B2|Baseline|Placebo|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
361336|NCT01090076|B1|Baseline|Abound|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
361337|NCT01090076|P2|Participant Flow|Placebo|Placebo x 2 sachets/d
361338|NCT01090076|P1|Participant Flow|Abound|Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal)
361339|NCT01090076|O2|Outcome|Placebo|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
361340|NCT01090076|O1|Outcome|Abound|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
361341|NCT01090076|O2|Outcome|Placebo|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
361342|NCT01090076|O1|Outcome|Abound|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
361343|NCT01090076|O2|Outcome|Placebo|Placebo x 2 sachets/d
361344|NCT01090076|O1|Outcome|Abound|Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal)
361345|NCT01090076|E2|Reported Event|Placebo|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
361346|NCT01090076|E1|Reported Event|Abound|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
361347|NCT01090063|B1|Baseline|Main|
361348|NCT01090063|P1|Participant Flow|Main|All participants were treated the same
361349|NCT01090063|O1|Outcome|Number of Participants With AEs|
361350|NCT01090063|O2|Outcome|Mean Week 24 Pain VAS Score|Average score of the pain VAS at Week 24. 100 indicates maximum pain (worse outcome), 0 indicates minimum pain (better outcome).
361351|NCT01090063|O1|Outcome|Mean Baseline Pain VAS Score|Average score of the pain VAS at baseline. 100 indicates maximum pain (worse outcome), 0 indicates minimum pain (better outcome).
361352|NCT01090063|O2|Outcome|Mean Week 24 Pruritus VAS Score|Average pruritus VAS score as measured at week 24. Maximum score is 100, minimum score is 0. 100 indicates maximum itch (worse outcome), 0 indicates minimum itch (better outcome).
361353|NCT01090063|O1|Outcome|Mean Baseline Pruritus VAS Score|Average pruritus VAS score as measured at baseline. Maximum score is 100, minimum score is 0. 100 indicates maximum itch (worse outcome), 0 indicates minimum itch (better outcome).
361354|NCT01090063|O2|Outcome|Mean Week 24 Fissure Count|Average number of fissures found on hands and feet at Week 24
361355|NCT01090063|O1|Outcome|Mean Baseline Fissure Count|Average number of fissures found on hands and feet at baseline
361356|NCT01090063|O2|Outcome|Mean Pustule Count at Week 24|Average number of pustules present in all subjects at week 24
361357|NCT01090063|O1|Outcome|Mean Pustule Count at Baseline|Average number of pustules present in all subjects at baseline
361358|NCT01090063|O1|Outcome|Median PGA|Median PGA at Week 24
361359|NCT01090063|O1|Outcome|Main|Percentage of patients achieving a palmar/plantar PGA score of 0 or 1 at week 16.
361360|NCT01090063|E1|Reported Event|Main|
361361|NCT01090050|B3|Baseline|Total|Total of all reporting groups
361362|NCT01090050|B2|Baseline|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to naproxen will treat daily with 1 tablet naproxen 500mg per day x 30 days. Subjects will be provided with 30 tablets of naproxen 500mg for rescue. In Treatment Period Months 2 and 3: Subjects randomized to naproxen will be provided with 14 tablets of naproxen 500mg to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of naproxen 500mg per month for rescue.
361363|NCT01090050|B1|Baseline|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Treximet will treat daily with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Treximet for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Treximet will be provided with 14 tablets of Treximet to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Treximet per month for rescue.
361364|NCT01090050|P2|Participant Flow|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
361365|NCT01090050|P1|Participant Flow|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
361366|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500 mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
361367|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85 mg / naproxen sodium 500 mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
361368|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500 mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
361428|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
365404|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 10 mg
361369|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85 mg / naproxen sodium 500 mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
361370|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
361371|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
361372|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
361373|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
361374|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
361375|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
361376|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
361377|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
361378|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
361379|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
361380|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
361381|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen will treat daily with 1 tablet Sumatriptan/Naproxen per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen will be provided with 14 tablets of Sumatriptan/Naproxen to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen per month for rescue.
361427|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
361382|NCT01090050|E2|Reported Event|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of naproxen 500mg to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
361383|NCT01090050|E1|Reported Event|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
361384|NCT01090011|B1|Baseline|Total Patients|"All patients entered and treated. The objective of this study was to determine the maximum tolerated dose of Afatinib using a 3+3 Up-and-Down trial design. Cohorts of three to six participants were entered (not randomized) sequentially into escalating dosage tiers of afatinib/cetuximab. The dose of cetuximab in successive cohorts was increased unless two or more of the six participants (of the current cohort) had dose limiting toxicity events."
361385|NCT01090011|P1|Participant Flow|Total Patients|"All patients entered and treated. The objective of this study was to determine the maximum tolerated dose of Afatinib using a 3+3 Up-and-Down trial design. Cohorts of three to six participants were entered (not randomized) sequentially into escalating dosage tiers of afatinib/cetuximab. The dose of cetuximab in successive cohorts was increased unless two or more of the six participants (of the current cohort) had dose limiting toxicity events."
361386|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361387|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
361388|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361389|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
361390|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361391|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
361392|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361393|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
361394|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361395|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
361396|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361397|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
361398|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361399|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
361400|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361401|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
361452|NCT01089751|B3|Baseline|Total|Total of all reporting groups
366780|NCT01077076|O3|Outcome|Placebo Capsules|
361402|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361403|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
361404|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361405|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
361406|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361407|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
361408|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361409|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
361410|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361411|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
361412|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361413|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
361414|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361415|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
361416|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361417|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
361418|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361419|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
361420|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361421|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
361422|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361423|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
361424|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361425|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
361426|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361429|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
361430|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361431|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
361432|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361433|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
361434|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361435|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
361436|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361437|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
361438|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361439|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
361440|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361441|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
361442|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361443|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the Maximum Tolerated Dose (MTD) determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
361444|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361445|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
361446|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
361447|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with Acquired Resistance (AR) to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
361448|NCT01090011|E4|Reported Event|Sequential Arm - Combination Therapy (Afa40+Ctx500)|Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
361449|NCT01090011|E3|Reported Event|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
361450|NCT01090011|E2|Reported Event|Combination Arm - Afa40+Ctx500|Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
361451|NCT01090011|E1|Reported Event|Combination Arm - Afa40+Ctx250|Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
361453|NCT01089751|B2|Baseline|Placebo|Placebo once daily on an empty stomach for 14 weeks.
361454|NCT01089751|B1|Baseline|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
361455|NCT01089751|P2|Participant Flow|Placebo|Placebo once daily on an empty stomach for 14 weeks.
361456|NCT01089751|P1|Participant Flow|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
361457|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
361458|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
361459|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
361460|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
361461|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
361462|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
361463|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
361464|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
361465|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
361466|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
361467|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
361468|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
361469|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
361470|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
361471|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
361472|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
361473|NCT01089751|E2|Reported Event|Placebo|Placebo once daily on an empty stomach for 14 weeks.
361474|NCT01089751|E1|Reported Event|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
361475|NCT01089608|B3|Baseline|Total|Total of all reporting groups
361476|NCT01089608|B2|Baseline|Azithromycin|"Eye drops Single dose unit~Azithromycin: Eye drops, Dosage : 1.5%~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
361477|NCT01089608|B1|Baseline|Unifluid|"Eye drops in Single Dose Unit~Povidone: Eye drops Single dose unit~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
361478|NCT01089608|P2|Participant Flow|Azithromycin|"Eye drops Single dose unit~Azithromycin: Eye drops, Dosage : 1.5%~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
361479|NCT01089608|P1|Participant Flow|Unifluid|"Eye drops in Single Dose Unit~Povidone: Eye drops Single dose unit~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
361480|NCT01089608|O2|Outcome|Azithromycin|"Eye drops Single dose unit~Azithromycin: Eye drops, Dosage : 1.5%~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
361481|NCT01089608|O1|Outcome|Unifluid|"Eye drops in Single Dose Unit~Povidone: Eye drops Single dose unit~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
361482|NCT01089608|E2|Reported Event|Azithromycin|"Eye drops Single dose unit~Azithromycin: Eye drops, Dosage : 1.5%~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
361483|NCT01089608|E1|Reported Event|Unifluid|"Eye drops in Single Dose Unit~Povidone: Eye drops Single dose unit~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
361484|NCT01089595|B3|Baseline|Total|Total of all reporting groups
361485|NCT01089595|B2|Baseline|Nilotinib + Imatinib|Nilotinib 400 mg BID with Imatinib 400 mg daily
361486|NCT01089595|B1|Baseline|Nilotinib|Nilotinib 400 mg po bid
361487|NCT01089595|P2|Participant Flow|Nilotinib + Imatinib|Nilotinib 400 mg BID with Imatinib 400 mg daily
361488|NCT01089595|P1|Participant Flow|Nilotinib|Nilotinib 400 mg po bid
361489|NCT01089595|O2|Outcome|Nilotinib + Imatinib|Nilotinib 400 mg BID with Imatinib 400 mg daily
361490|NCT01089595|O1|Outcome|Nilotinib|Nilotinib 400 mg po bid
361491|NCT01089595|O2|Outcome|Nilotinib + Imatinib|Nilotinib 400 mg twice daily (BID) with Imatinib 400 mg daily
361492|NCT01089595|O1|Outcome|Nilotinib|Nilotinib 400 mg by mouth (PO), twice daily (BID)
361493|NCT01089595|E2|Reported Event|Nilotinib + Imatinib|Nilotinib 400 mg BID with Imatinib 400 mg daily
361494|NCT01089595|E1|Reported Event|Nilotinib|Nilotinib 400 mg po bid
361495|NCT01089582|B1|Baseline|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
361496|NCT01089582|P1|Participant Flow|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
361497|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
361498|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
366875|NCT01076647|B3|Baseline|Total|Total of all reporting groups
361499|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
361500|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
361501|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
361502|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
361503|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
361504|NCT01089582|E1|Reported Event|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
361505|NCT01089569|B4|Baseline|Total|Total of all reporting groups
361506|NCT01089569|B3|Baseline|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study~+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
361507|NCT01089569|B2|Baseline|Insulin Glargine|".1 unit per kg to start, titrated based on Continuous Glucose Monitoring results~Insulin Glargine: refer to Arm detail"
361508|NCT01089569|B1|Baseline|Exenatide|"5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study~Exenatide: refer to Arm detail"
361509|NCT01089569|P3|Participant Flow|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study~+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
361510|NCT01089569|P2|Participant Flow|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
361511|NCT01089569|P1|Participant Flow|Exenatide|5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
361512|NCT01089569|O3|Outcome|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study~+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
361513|NCT01089569|O2|Outcome|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
361514|NCT01089569|O1|Outcome|Exenatide|5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
361515|NCT01089569|O3|Outcome|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study~+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
361516|NCT01089569|O2|Outcome|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
361517|NCT01089569|O1|Outcome|Exenatide|5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
361518|NCT01089569|O3|Outcome|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study~+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
361519|NCT01089569|O2|Outcome|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
361520|NCT01089569|O1|Outcome|Exenatide|5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
361521|NCT01089569|O3|Outcome|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study~+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
361522|NCT01089569|O2|Outcome|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
361523|NCT01089569|O1|Outcome|Exenatide|5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
361524|NCT01089569|O3|Outcome|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study~+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
361525|NCT01089569|O2|Outcome|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
361526|NCT01089569|O1|Outcome|Exenatide|5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
361527|NCT01089569|O3|Outcome|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study~+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
361528|NCT01089569|O2|Outcome|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
361529|NCT01089569|O1|Outcome|Exenatide|5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
361530|NCT01089569|O3|Outcome|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study~+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
361531|NCT01089569|O2|Outcome|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
361532|NCT01089569|O1|Outcome|Exenatide|5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
361533|NCT01089569|E3|Reported Event|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study~+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
361534|NCT01089569|E2|Reported Event|Insulin Glargine|".1 unit per kg to start, titrated based on Continuous Glucose Monitoring results~Insulin Glargine: refer to Arm detail"
361535|NCT01089569|E1|Reported Event|Exenatide|"5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study~Exenatide: refer to Arm detail"
361536|NCT01089556|B3|Baseline|Total|Total of all reporting groups
361537|NCT01089556|B2|Baseline|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
361538|NCT01089556|B1|Baseline|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
361539|NCT01089556|P6|Participant Flow|Pregabalin (SP III)|Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16 in Study Period III.
361540|NCT01089556|P5|Participant Flow|PGB + DLX (SP III)|Pregabalin (PGB) 300 mg plus Duloxetine (DLX) 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16 in Study Period III.
361541|NCT01089556|P4|Participant Flow|DLX + PGB (SP III)|Duloxetine (DLX) 60 mg plus Pregabalin (PGB) 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16 in Study Period III.
361542|NCT01089556|P3|Participant Flow|Duloxetine (SP III)|Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16 in Study Period III (SP III).
361543|NCT01089556|P2|Participant Flow|Pregabalin (SP II)|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
361544|NCT01089556|P1|Participant Flow|Duloxetine (SP II)|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II (SP II).
361545|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
361546|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
361547|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
361548|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
361549|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
361550|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
361551|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
361552|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
361553|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
361554|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
361555|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
361556|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
361557|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
361558|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
361559|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
361560|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
361561|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
361562|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
361563|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
361564|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
361565|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
361566|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
361567|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
361568|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
361569|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
361570|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
361571|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
361572|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
361573|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
361574|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
361575|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
361576|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
361577|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
361578|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
361579|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
361580|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
361581|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
361582|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
361583|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
361584|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
361585|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
361586|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
361587|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
361588|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
361589|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
361590|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
361591|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
361592|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
361593|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
361594|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
361595|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
361596|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
361639|NCT01089517|P2|Participant Flow|E10030 0.3 mg/Lucentis 0.5 mg|E10030 0.3 mg/Lucentis 0.5 mg
361597|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
361598|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
361599|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
361600|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
361601|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
361602|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
361603|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
361604|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
361605|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
361606|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
361607|NCT01089556|E6|Reported Event|Pregabalin (SP III)|Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16 in Study Period III.
361608|NCT01089556|E5|Reported Event|PGB + DLX (SP III)|Pregabalin (PGB) 300 mg plus Duloxetine (DLX) 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16 in Study Period III.
361609|NCT01089556|E4|Reported Event|DLX + PGB (SP III)|Duloxetine (DLX) 60 mg plus Pregabalin (PGB) 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16 in Study Period III.
361610|NCT01089556|E3|Reported Event|Duloxetine (SP III)|Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16 in Study Period III (SP III).
361611|NCT01089556|E2|Reported Event|Pregabalin (SP II)|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
361612|NCT01089556|E1|Reported Event|Duloxetine (SP II)|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II (SP II).
361613|NCT01089543|B5|Baseline|Total|Total of all reporting groups
361614|NCT01089543|B4|Baseline|Placebo|Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
361615|NCT01089543|B3|Baseline|Rabeprazole 40 mg|Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
361616|NCT01089543|B2|Baseline|Rabeprazole 20 mg|Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
361617|NCT01089543|B1|Baseline|Rabeprazole 10 mg|Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
361618|NCT01089543|P4|Participant Flow|Placebo|Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
361619|NCT01089543|P3|Participant Flow|Rabeprazole 40 mg|Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
361620|NCT01089543|P2|Participant Flow|Rabeprazole 20 mg|Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
361621|NCT01089543|P1|Participant Flow|Rabeprazole 10 mg|Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
361622|NCT01089543|O4|Outcome|Placebo|Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
361623|NCT01089543|O3|Outcome|Rabeprazole 40 mg|Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
361624|NCT01089543|O2|Outcome|Rabeprazole 20 mg|Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
361625|NCT01089543|O1|Outcome|Rabeprazole 10 mg|Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
361626|NCT01089543|O4|Outcome|Placebo|Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
361627|NCT01089543|O3|Outcome|Rabeprazole 40 mg|Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
361628|NCT01089543|O2|Outcome|Rabeprazole 20 mg|Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
361629|NCT01089543|O1|Outcome|Rabeprazole 10 mg|Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
361630|NCT01089543|E4|Reported Event|Placebo|Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
361631|NCT01089543|E3|Reported Event|Rabeprazole 40 mg|Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
361632|NCT01089543|E2|Reported Event|Rabeprazole 20 mg|Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
361633|NCT01089543|E1|Reported Event|Rabeprazole 10 mg|Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
361634|NCT01089517|B4|Baseline|Total|Total of all reporting groups
361635|NCT01089517|B3|Baseline|E10030 High Dose Plus Lucentis|E10030 1.5 mg/Lucentis 0.5 mg
361636|NCT01089517|B2|Baseline|E10030 Low Dose Plus Lucentis|E10030 0.3 mg/Lucentis 0.5 mg
361637|NCT01089517|B1|Baseline|Lucentis|Sham/Lucentis 0.5 mg
361638|NCT01089517|P3|Participant Flow|E10030 1.5 mg/Lucentis 0.5 mg|E10030 1.5 mg/Lucentis 0.5 mg
361641|NCT01089517|O3|Outcome|E10030 1.5 mg/Lucentis 0.5 mg|E10030 1.5 mg/Lucentis 0.5 mg
361642|NCT01089517|O2|Outcome|E10030 0.3 mg/Lucentis 0.5 mg|E10030 0.3 mg/Lucentis 0.5 mg
361643|NCT01089517|O1|Outcome|Lucentis|Sham/Lucentis 0.5 mg
361644|NCT01089517|O3|Outcome|E10030 1.5 mg/Lucentis 0.5 mg|E10030 1.5 mg/Lucentis 0.5 mg
361645|NCT01089517|O2|Outcome|E10030 0.3 mg/Lucentis 0.5 mg|E10030 0.3 mg/Lucentis 0.5 mg
361646|NCT01089517|O1|Outcome|Lucentis|Sham/Lucentis 0.5 mg
361647|NCT01089517|O3|Outcome|E10030 1.5 mg/Lucentis 0.5 mg|E10030 1.5 mg/Lucentis 0.5 mg
361648|NCT01089517|O2|Outcome|E10030 0.3 mg/Lucentis 0.5 mg|E10030 0.3 mg/Lucentis 0.5 mg
361649|NCT01089517|O1|Outcome|Lucentis|Sham/Lucentis 0.5 mg
361650|NCT01089517|E3|Reported Event|E10030 High Dose Plus Lucentis|E10030 1.5 mg/Lucentis 0.5 mg
361651|NCT01089517|E2|Reported Event|E10030 Low Dose Plus Lucentis|E10030 0.3 mg/Lucentis 0.5 mg
361652|NCT01089517|E1|Reported Event|Lucentis|Sham/Lucentis 0.5 mg
361653|NCT01089504|B3|Baseline|Total|Total of all reporting groups
361654|NCT01089504|B2|Baseline|Placebo|"Placebo in a volume equivalent to active drug for 4 months~placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
361655|NCT01089504|B1|Baseline|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months~phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
361656|NCT01089504|P2|Participant Flow|Placebo|"Placebo in a volume equivalent to active drug for 4 months~placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
361657|NCT01089504|P1|Participant Flow|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months~phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
361658|NCT01089504|O2|Outcome|Placebo|"Placebo in a volume equivalent to active drug for 4 months~placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
361659|NCT01089504|O1|Outcome|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months~phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
361660|NCT01089504|O2|Outcome|Placebo|"Placebo in a volume equivalent to active drug for 4 months~placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
361661|NCT01089504|O1|Outcome|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months~phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
361662|NCT01089504|O2|Outcome|Placebo|"Placebo in a volume equivalent to active drug for 4 months~placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
361663|NCT01089504|O1|Outcome|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months~phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
361664|NCT01089504|E2|Reported Event|Placebo|"Placebo in a volume equivalent to active drug for 4 months~placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
361665|NCT01089504|E1|Reported Event|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months~phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
361666|NCT01089413|B4|Baseline|Total|Total of all reporting groups
361667|NCT01089413|B3|Baseline|Bevacizumab: Age >80 Years|Participants aged greater than (>) 80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
361668|NCT01089413|B2|Baseline|Bevacizumab: Age 70-80 Years|Participants aged between 70-80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
361669|NCT01089413|B1|Baseline|Bevacizumab: Age <70 Years|Participants aged less than (<) 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
361670|NCT01089413|P1|Participant Flow|Bevacizumab: Overall|All participants with Metastatic Colorectal Cancer (mCRC) for whom the physician decided to prescribe bevacizumab (Avastin) as part of their first line treatment and in line with current Summary of Product Characteristics (SmPC) (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
361671|NCT01089413|O4|Outcome|Bevacizumab: Overall|All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
361672|NCT01089413|O3|Outcome|Bevacizumab: Age >80 Years|Participants aged >80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
361673|NCT01089413|O2|Outcome|Bevacizumab: Age 70-80 Years|Participants aged between 70-80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
361674|NCT01089413|O1|Outcome|Bevacizumab: Age <70 Years|Participants aged <70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
361695|NCT01089361|O2|Outcome|Ketamine|The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
363131|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
361675|NCT01089413|O4|Outcome|Bevacizumab: Overall|All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
361676|NCT01089413|O3|Outcome|Bevacizumab: Age >80 Years|Participants aged >80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
361677|NCT01089413|O2|Outcome|Bevacizumab: Age 70-80 Years|Participants aged between 70-80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
361678|NCT01089413|O1|Outcome|Bevacizumab: Age <70 Years|Participants aged <70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
361679|NCT01089413|O3|Outcome|Bevacizumab: Overall|All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
361680|NCT01089413|O2|Outcome|Bevacizumab: Age ≥70 Years|Participants aged greater than or equal to (≥) 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. Due to the small number of participants aged >80 years, the age groups “70-80 Years” and “>80 Years” have been pooled in this group.
361681|NCT01089413|O1|Outcome|Bevacizumab: Age <70 Years|Participants aged < 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
361682|NCT01089413|O3|Outcome|Bevacizumab: Overall|All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
361683|NCT01089413|O2|Outcome|Bevacizumab: Age ≥70 Years|Participants aged greater than or equal to (≥) 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. Due to the small number of participants aged >80 years, the age groups “70-80 Years” and “>80 Years” have been pooled in this group.
361684|NCT01089413|O1|Outcome|Bevacizumab: Age <70 Years|Participants aged < 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
361685|NCT01089413|E1|Reported Event|Bevacizumab: Overall|All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
361686|NCT01089361|B3|Baseline|Total|Total of all reporting groups
361687|NCT01089361|B2|Baseline|Ketamine|The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
361688|NCT01089361|B1|Baseline|Normal Saline|The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
361689|NCT01089361|P2|Participant Flow|Ketamine|The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
361690|NCT01089361|P1|Participant Flow|Normal Saline|The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
361691|NCT01089361|O2|Outcome|Ketamine|"The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.~Ketamine: The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours."
361692|NCT01089361|O1|Outcome|Normal Saline Placebo|"The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.~Normal Saline placebo: The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours."
361693|NCT01089361|O2|Outcome|Ketamine|The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
361694|NCT01089361|O1|Outcome|Normal Saline|The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
361780|NCT01089062|O2|Outcome|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
361696|NCT01089361|O1|Outcome|Normal Saline|The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
361697|NCT01089361|O2|Outcome|Ketamine|The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
361698|NCT01089361|O1|Outcome|Normal Saline|The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
361699|NCT01089361|O2|Outcome|Ketamine|The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
361700|NCT01089361|O1|Outcome|Normal Saline|The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
361701|NCT01089361|O2|Outcome|Ketamine|The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
361702|NCT01089361|O1|Outcome|Normal Saline|The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
361703|NCT01089361|O2|Outcome|Ketamine|The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
361704|NCT01089361|O1|Outcome|Normal Saline|The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
361705|NCT01089361|E2|Reported Event|Ketamine|The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
361706|NCT01089361|E1|Reported Event|Normal Saline|The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
361707|NCT01089231|B5|Baseline|Total|Total of all reporting groups
361708|NCT01089231|B4|Baseline|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
361709|NCT01089231|B3|Baseline|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
361710|NCT01089231|B2|Baseline|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
361711|NCT01089231|B1|Baseline|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
361712|NCT01089231|P4|Participant Flow|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
361713|NCT01089231|P3|Participant Flow|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
361714|NCT01089231|P2|Participant Flow|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
361715|NCT01089231|P1|Participant Flow|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
361716|NCT01089231|O4|Outcome|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
361717|NCT01089231|O3|Outcome|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
361718|NCT01089231|O2|Outcome|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
361719|NCT01089231|O1|Outcome|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
361720|NCT01089231|O4|Outcome|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
361721|NCT01089231|O3|Outcome|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
361722|NCT01089231|O2|Outcome|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
361723|NCT01089231|O1|Outcome|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
361724|NCT01089231|O4|Outcome|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
361725|NCT01089231|O3|Outcome|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
361726|NCT01089231|O2|Outcome|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
361727|NCT01089231|O1|Outcome|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
361728|NCT01089231|E4|Reported Event|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
361729|NCT01089231|E3|Reported Event|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
361730|NCT01089231|E2|Reported Event|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
361731|NCT01089231|E1|Reported Event|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
361732|NCT01089127|B7|Baseline|Total|Total of all reporting groups
361733|NCT01089127|B6|Baseline|Placebo|Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361734|NCT01089127|B5|Baseline|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361735|NCT01089127|B4|Baseline|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361736|NCT01089127|B3|Baseline|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361737|NCT01089127|B2|Baseline|Indacaterol 37.5 μg|Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361738|NCT01089127|B1|Baseline|Indacaterol 18.75 μg|Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361739|NCT01089127|P6|Participant Flow|Placebo|Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361740|NCT01089127|P5|Participant Flow|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361741|NCT01089127|P4|Participant Flow|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361742|NCT01089127|P3|Participant Flow|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361743|NCT01089127|P2|Participant Flow|Indacaterol 37.5 μg|Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361744|NCT01089127|P1|Participant Flow|Indacaterol 18.75 μg|Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361745|NCT01089127|O6|Outcome|Placebo|Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361746|NCT01089127|O5|Outcome|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361781|NCT01089062|O1|Outcome|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
361782|NCT01089062|O3|Outcome|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
361747|NCT01089127|O4|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361748|NCT01089127|O3|Outcome|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361749|NCT01089127|O2|Outcome|Indacaterol 37.5 μg|Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361750|NCT01089127|O1|Outcome|Indacaterol 18.75 μg|Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361751|NCT01089127|O6|Outcome|Placebo|Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361752|NCT01089127|O5|Outcome|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361753|NCT01089127|O4|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361754|NCT01089127|O3|Outcome|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361755|NCT01089127|O2|Outcome|Indacaterol 37.5 μg|Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361756|NCT01089127|O1|Outcome|Indacaterol 18.75 μg|Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361757|NCT01089127|E6|Reported Event|Placebo|Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361758|NCT01089127|E5|Reported Event|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361759|NCT01089127|E4|Reported Event|Indacaterol 150 ug|Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361783|NCT01089062|O2|Outcome|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
361784|NCT01089062|O1|Outcome|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose 2 hours from time of first dose.
361760|NCT01089127|E3|Reported Event|Indacaterol 75 ug|Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361761|NCT01089127|E2|Reported Event|Indacaterol 37.5 ug|Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361762|NCT01089127|E1|Reported Event|Indacaterol 18.75 ug|Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
361763|NCT01089062|B7|Baseline|Total|Total of all reporting groups
361764|NCT01089062|B6|Baseline|Treatment C, Then B, Then A|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
361765|NCT01089062|B5|Baseline|Treatment C, Then A, Then B|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
361766|NCT01089062|B4|Baseline|Treatment B, Then C, Then A|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
361767|NCT01089062|B3|Baseline|Treatment B, Then A, Then C|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
361768|NCT01089062|B2|Baseline|Treatment A, Then C, Then B|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
361769|NCT01089062|B1|Baseline|Treatment A, Then B, Then C|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
361770|NCT01089062|P6|Participant Flow|Treatment C, Then B, Then A|"The second dose in each treatment group (C,B,A) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 2.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 3.~Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 4."
361771|NCT01089062|P5|Participant Flow|Treatment C, Then A, Then B|"The second dose in each treatment group (C,A,B) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 2.~Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 3.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 4."
361772|NCT01089062|P4|Participant Flow|Treatment B, Then C, Then A|"The second dose in each treatment group (B,C,A) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 2.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 3.~Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 4."
361773|NCT01089062|P3|Participant Flow|Treatment B, Then A, Then C|"The second dose in each treatment group (B,A,C) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 2.~Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 3.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 4."
361774|NCT01089062|P2|Participant Flow|Treatment A, Then C, Then B|"The second dose in each treatment group (A,C,B) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.~Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 2.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 3.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 4."
361775|NCT01089062|P1|Participant Flow|Treatment A, Then B, Then C|"The second dose in each treatment group (A,B,C) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.~Treatment A = inhaler placebo and Intravenous (IV) Dihydroergotamine (DHE) for first dose, inhaler placebo for second dose at Visit 2.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 3.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 4."
361776|NCT01089062|O3|Outcome|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
361777|NCT01089062|O2|Outcome|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
361778|NCT01089062|O1|Outcome|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
361779|NCT01089062|O3|Outcome|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
361785|NCT01089062|O3|Outcome|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
361786|NCT01089062|O2|Outcome|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
361787|NCT01089062|O1|Outcome|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
361788|NCT01089062|O3|Outcome|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
361789|NCT01089062|O2|Outcome|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
361790|NCT01089062|O1|Outcome|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
361791|NCT01089062|O3|Outcome|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
361792|NCT01089062|O2|Outcome|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
361793|NCT01089062|O1|Outcome|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
361794|NCT01089062|E3|Reported Event|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
361795|NCT01089062|E2|Reported Event|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
361796|NCT01089062|E1|Reported Event|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
361797|NCT01089023|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
361798|NCT01089023|P1|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg intravenous (IV) infusion, once every 4 weeks for a total of 6 infusions.
361799|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
361800|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
361801|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
361802|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
361803|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
361804|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
361805|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
361806|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
361807|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
361808|NCT01089023|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg iv infusion, every 4 weeks for a total of 6 infusions.
361809|NCT01088997|B3|Baseline|Total|Total of all reporting groups
361810|NCT01088997|B2|Baseline|Low Dose Milrinone|Subjects received a 20mcg/kg loading dose of milrinone lactate given intravenously (IV) over 1 hour followed by an IV infusion of 0.2mcg/kg over 24 hours
361811|NCT01088997|B1|Baseline|High Dose Milrinone|Subjects received a 50mcg/kg loading dose of milrinone lactate given intravenously (IV) over 1 hour followed by an IV infusion of 0.5mcg/kg over 24 hours
361812|NCT01088997|P2|Participant Flow|Low Dose Milrinone|Subjects received a 20 mcg/kg loading dose of milrinone lactate given intravenously (IV) over 1 hour followed by an IV infusion of 0.2 mcg/kg/min over 24 hours.
361813|NCT01088997|P1|Participant Flow|High Dose Milrinone|Subjects received a 50 mcg/kg loading dose of milrinone lactate given intravenously (IV) over 1 hour followed by an IV infusion of 0.5 mcg/kg/min over 24 hours.
361814|NCT01088997|O2|Outcome|Low Dose Milrinone|5 subjects were enrolled into the study, of these 2 completed study treatment and only 1 received 2 MPI measurements
361815|NCT01088997|O1|Outcome|High Dose Milrinone|7 subjects were enrolled into the study, of these 4 completed study treatment.
361816|NCT01088997|O1|Outcome|Milrinone Population|Population model developed based on 6 subjects who completed study treatment and were deemed evaluable.
361817|NCT01088997|O2|Outcome|Low Dose Milrinone|5 subjects were enrolled into this arm, of these only 2 completed study treatment.
361818|NCT01088997|O1|Outcome|High Dose Milrinone|7 subjects were enrolled into this arm, of these only 4 completed study treatment.
361819|NCT01088997|E2|Reported Event|Low Dose Milrinone|Subjects received a bolus intravenous (IV) infusion of 20 mcg/kg/min of milrinone lactate over 1 hour followed by a continuous IV infusion of 0.2 mcg/kg/min milrinone lactate over 24 hours.
361820|NCT01088997|E1|Reported Event|High Dose Milrinone|Subjects received a bolus intravenous (IV) infusion of 50 mcg/kg/min of milrinone lactate over 1 hour followed by a continuous IV infusion of 0.5 mcg/kg/min milrinone lactate over 24 hours.
361821|NCT01088984|B3|Baseline|Total|Total of all reporting groups
361822|NCT01088984|B2|Baseline|Phase 2: Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
361823|NCT01088984|B1|Baseline|Phase 1: Bendamustine 90 or 120 mg/m^2|Bendamustine 90 or 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of a 21-day Induction Cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
361824|NCT01088984|P2|Participant Flow|Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
361825|NCT01088984|P1|Participant Flow|Bendamustine 90 mg/m^2|Bendamustine 90 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of a 21-day Induction cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
369076|NCT01071252|B6|Baseline|Total|Total of all reporting groups
361826|NCT01088984|O2|Outcome|Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
361827|NCT01088984|O1|Outcome|Bendamustine 90 mg/m^2|Bendamustine 90 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of a 21-day Induction cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
361828|NCT01088984|O2|Outcome|Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
361829|NCT01088984|O1|Outcome|Bendamustine 90 mg/m^2|Bendamustine 90 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of a 21-day Induction cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
361830|NCT01088984|O2|Outcome|Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
361831|NCT01088984|O1|Outcome|Bendamustine 90 mg/m^2|Bendamustine 90 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of a 21-day Induction cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
361832|NCT01088984|O2|Outcome|Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
361833|NCT01088984|O1|Outcome|Bendamustine 90 mg/m^2|Bendamustine 90 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of a 21-day Induction cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
361834|NCT01088984|O1|Outcome|Phase 2: Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
361835|NCT01088984|O3|Outcome|Total|Bendamustine 90 or 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
361836|NCT01088984|O2|Outcome|Phase 2: Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
361837|NCT01088984|O1|Outcome|Phase 1: Bendamustine 90 or 120 mg/m^2|Bendamustine 90 or 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of a 21-day Induction Cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
361838|NCT01088984|O1|Outcome|Phase 2: Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
361839|NCT01088984|O1|Outcome|Phase 2: Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
361840|NCT01088984|O1|Outcome|Phase 1: Bendamustine 90 or 120 mg/m^2|Bendamustine 90 or 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of a 21-day Induction Cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
361841|NCT01088984|E1|Reported Event|Bendamustine|Bendamustine 90 or 120 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
361842|NCT01088711|B5|Baseline|Total|Total of all reporting groups
361843|NCT01088711|B4|Baseline|T2D - Placebo|Obese T2D participants received once-weekly placebo for 4 weeks.
361844|NCT01088711|B3|Baseline|T2D - Omarigliptin|Obese T2D participants received once-weekly omarigliptin for 4 weeks.
361845|NCT01088711|B2|Baseline|T2D Participants (Panel B)|Obese participants with T2D received once-weekly omarigliptin or placebo for 4 weeks.
361846|NCT01088711|B1|Baseline|Healthy Participants - Omarigliptin|Obese healthy participants received once-weekly omarigliptin for 4 weeks.
361847|NCT01088711|P4|Participant Flow|T2D - Placebo|Obese T2D participants received once-weekly placebo for 4 weeks.
361848|NCT01088711|P3|Participant Flow|T2D - Omarigliptin|Obese T2D participants received once-weekly omarigliptin for 4 weeks.
361849|NCT01088711|P2|Participant Flow|Healthy - Placebo|Obese healthy participants received once-weekly placebo for 4 weeks.
361850|NCT01088711|P1|Participant Flow|Healthy Participants - Omarigliptin|Obese healthy participants received once-weekly omarigliptin for 4 weeks.
361851|NCT01088711|O2|Outcome|Placebo|Obese healthy and T2D participants received once-weekly placebo for 4 weeks.
361852|NCT01088711|O1|Outcome|Omarigliptin 50 mg|Obese healthy and T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
361853|NCT01088711|O2|Outcome|Placebo|Obese healthy and T2D participants received once-weekly placebo for 4 weeks.
361854|NCT01088711|O1|Outcome|Omarigliptin 50 mg|Obese healthy and T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
361855|NCT01088711|O2|Outcome|Placebo|Obese healthy and T2D participants received once-weekly placebo for 4 weeks.
361856|NCT01088711|O1|Outcome|Omarigliptin 50 mg|Obese healthy and T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
361857|NCT01088711|O2|Outcome|Placebo|Obese healthy and T2D participants received once-weekly placebo for 4 weeks.
361858|NCT01088711|O1|Outcome|Omarigliptin 50 mg|Obese healthy and T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
361859|NCT01088711|O2|Outcome|Placebo|Obese healthy and T2D participants received once-weekly placebo for 4 weeks.
361860|NCT01088711|O1|Outcome|Omarigliptin 50 mg|Obese healthy and T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
361861|NCT01088711|O4|Outcome|T2D Placebo|Obese participants with T2D received once-weekly placebo for 4 weeks (Panel B).
361862|NCT01088711|O3|Outcome|T2D Omarigliptin|Obese participants with T2D received once-weekly omarigliptin 50 mg for 4 weeks (Panel B).
361863|NCT01088711|O2|Outcome|Healthy Placebo|Obese healthy participants received once-weekly placebo for 4 weeks (Panel A).
361864|NCT01088711|O1|Outcome|Healthy Omarigliptin|Obese healthy participants received once-weekly omarigliptin 50 mg for 4 weeks (Panel A).
361865|NCT01088711|O4|Outcome|T2D Placebo|Obese participants with T2D received once-weekly placebo for 4 weeks (Panel B).
361866|NCT01088711|O3|Outcome|T2D Omarigliptin|Obese participants with T2D received once-weekly omarigliptin 50 mg for 4 weeks (Panel B).
361867|NCT01088711|O2|Outcome|Healthy Placebo|Obese healthy participants received once-weekly placebo for 4 weeks (Panel A).
361868|NCT01088711|O1|Outcome|Healthy Omarigliptin|Obese healthy participants received once-weekly omarigliptin 50 mg for 4 weeks (Panel A).
361869|NCT01088711|E4|Reported Event|Placebo T2D (Panel B)|Obese T2D participants received once-weekly placebo for 4 weeks.
361870|NCT01088711|E3|Reported Event|Omarigliptin 50 mg T2D (Panel B)|Obese T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
361871|NCT01088711|E2|Reported Event|Placebo Healthy (Panel A)|Obese healthy participants received once-weekly placebo for 4 weeks.
361872|NCT01088711|E1|Reported Event|Omarigliptin 50 mg Healthy (Panel A)|Obese healthy participants received once-weekly omarigliptin 50 mg for 4 weeks.
361873|NCT01088672|B1|Baseline|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke~Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
361874|NCT01088672|P1|Participant Flow|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke~Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
361875|NCT01088672|O1|Outcome|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke~Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
361876|NCT01088672|O1|Outcome|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke~Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
361877|NCT01088672|O1|Outcome|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke~Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
361878|NCT01088672|E1|Reported Event|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke~Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
361879|NCT01088646|B1|Baseline|PillCam Express Capsule Delivery System|PillCam® Express Capsule Endoscopy Delivery System was used in conjunction with the endoscope to introduce a PillCam® SB capsule into the proximal duodenum. After the capsule was released in the designated location, a standard of care upper GI endoscopy was performed.
361880|NCT01088646|P1|Participant Flow|PillCam Express Capsule Delivery System|PillCam® Express Capsule Endoscopy Delivery System was used in conjunction with the endoscope to introduce a PillCam® SB capsule into the proximal duodenum. After the capsule was released in the designated location, a standard of care upper GI endoscopy was performed.
361881|NCT01088646|O1|Outcome|Pillcam Express Capsule Delivery System|The delivery system is comprised of three parts: a catheter, a syringe and a capsule holder.
361882|NCT01088646|E1|Reported Event|PillCam Express Capsule Delivery System|PillCam® Express Capsule Endoscopy Delivery System was used in conjunction with the endoscope to introduce a PillCam® SB capsule into the proximal duodenum. After the capsule was released in the designated location, a standard of care upper GI endoscopy was performed.
361883|NCT01088529|B3|Baseline|Total|Total of all reporting groups
361884|NCT01088529|B2|Baseline|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
361885|NCT01088529|B1|Baseline|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
361886|NCT01088529|P2|Participant Flow|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
361887|NCT01088529|P1|Participant Flow|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
361888|NCT01088529|O2|Outcome|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
361889|NCT01088529|O1|Outcome|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
362200|NCT01087814|B1|Baseline|Efavirenz|Both arms received both versions of the drug during the course of the study.
361890|NCT01088529|O2|Outcome|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
361891|NCT01088529|O1|Outcome|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
361892|NCT01088529|O2|Outcome|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
361893|NCT01088529|O1|Outcome|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
361894|NCT01088529|E2|Reported Event|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
361895|NCT01088529|E1|Reported Event|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
361896|NCT01088503|B4|Baseline|Total|Total of all reporting groups
361897|NCT01088503|B3|Baseline|Ticlopidine/Ticagrelor|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with ticlopidine or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician.
361898|NCT01088503|B2|Baseline|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
361899|NCT01088503|B1|Baseline|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
361900|NCT01088503|P3|Participant Flow|Ticlopidine/Ticagrelor|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with ticlopidine or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician.
361901|NCT01088503|P2|Participant Flow|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
361902|NCT01088503|P1|Participant Flow|Prasugrel|Participants who were admitted for non ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI) and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
361903|NCT01088503|O2|Outcome|Other|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel, or ticlopidine, or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician
361904|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
361905|NCT01088503|O2|Outcome|Other|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel, or ticlopidine, or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician
361906|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
361907|NCT01088503|O2|Outcome|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
361908|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
361909|NCT01088503|O2|Outcome|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
361910|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
361911|NCT01088503|O2|Outcome|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
361912|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
361913|NCT01088503|O2|Outcome|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
361914|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
361915|NCT01088503|O2|Outcome|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
361916|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
361917|NCT01088503|O2|Outcome|Other|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel, or ticlopidine, or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician
361918|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
362000|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
361919|NCT01088503|O2|Outcome|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
361920|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
361921|NCT01088503|E1|Reported Event|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
361922|NCT01088464|B4|Baseline|Total|Total of all reporting groups
361923|NCT01088464|B3|Baseline|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361924|NCT01088464|B2|Baseline|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361925|NCT01088464|B1|Baseline|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361926|NCT01088464|P3|Participant Flow|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361927|NCT01088464|P2|Participant Flow|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361928|NCT01088464|P1|Participant Flow|Cohort 1: Necitumumab|Necitumumab 600 milligrams (mg) administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361929|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361930|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361931|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361932|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361933|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361934|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361935|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361936|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361937|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361938|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361939|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361940|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361941|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361999|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
361942|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361943|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361944|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361945|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361946|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361947|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361948|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361949|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361950|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361951|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361952|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361953|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361954|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361955|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361956|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361957|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361958|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361959|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361960|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361961|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361962|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361963|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
369228|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50, or 70mg"
361964|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361965|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361966|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361967|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361968|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361969|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361970|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361971|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361972|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361973|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361974|NCT01088464|E3|Reported Event|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361975|NCT01088464|E2|Reported Event|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361976|NCT01088464|E1|Reported Event|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
361977|NCT01088438|B3|Baseline|Total|Total of all reporting groups
361978|NCT01088438|B2|Baseline|Control|No intervention
361979|NCT01088438|B1|Baseline|Contextualization Workshop|A four-hour course on contextualization.
361980|NCT01088438|P2|Participant Flow|Control|No intervention
361981|NCT01088438|P1|Participant Flow|Contextualization Workshop|A four-hour course on contextualization.
361982|NCT01088438|O2|Outcome|Control|No intervention
361983|NCT01088438|O1|Outcome|Contextualization Workshop|A four-hour course on contextualization.
361984|NCT01088438|O2|Outcome|Control|No intervention
361985|NCT01088438|O1|Outcome|Contextualization Workshop|A four-hour course on contextualization.
361986|NCT01088438|O2|Outcome|Control|No intervention
361987|NCT01088438|O1|Outcome|Contextualization Workshop|A four-hour course on contextualization.
361988|NCT01088438|E2|Reported Event|Control|No intervention
361989|NCT01088438|E1|Reported Event|Contextualization Workshop|A four-hour course on contextualization.
361990|NCT01088399|B4|Baseline|Total|Total of all reporting groups
361991|NCT01088399|B3|Baseline|Unknown|It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
361992|NCT01088399|B2|Baseline|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
361993|NCT01088399|B1|Baseline|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
361994|NCT01088399|P3|Participant Flow||It is not known whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
361995|NCT01088399|P2|Participant Flow|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
361996|NCT01088399|P1|Participant Flow|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
361997|NCT01088399|O3|Outcome|Unknown|It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
361998|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
363132|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
362001|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
362002|NCT01088399|O3|Outcome|Unknown|It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
362003|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
362004|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
362005|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
362006|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
362007|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
362008|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
362009|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
362010|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
362011|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
362012|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
362013|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
362014|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
362015|NCT01088399|E3|Reported Event||It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
362016|NCT01088399|E2|Reported Event|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
362017|NCT01088399|E1|Reported Event|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
362018|NCT01088295|B1|Baseline|Telmisartan|Telmisartan 40mg po daily for 24 weeks
362019|NCT01088295|P1|Participant Flow|Telmisartan|Telmisartan 40mg po daily for 24 weeks
362020|NCT01088295|O1|Outcome|Telmisartan|Telmisartan 40mg po daily for 24 weeks
362021|NCT01088295|E1|Reported Event|Telmisartan|
362022|NCT01088243|B3|Baseline|Total|Total of all reporting groups
362023|NCT01088243|B2|Baseline|Placebo|"Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.~Placebo: Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects."
362024|NCT01088243|B1|Baseline|Mesalamine|"Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.~Mesalamine: Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects."
362025|NCT01088243|P2|Participant Flow|Placebo|"Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.~Placebo: Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects."
362026|NCT01088243|P1|Participant Flow|Mesalamine|"Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.~Mesalamine: Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects."
362027|NCT01088243|O2|Outcome|Placebo|"Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.~Placebo: Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects."
362028|NCT01088243|O1|Outcome|Mesalamine|"Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.~Mesalamine: Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects."
362029|NCT01088243|O2|Outcome|Placebo|"Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.~Placebo: Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects."
362030|NCT01088243|O1|Outcome|Mesalamine|"Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.~Mesalamine: Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects."
362031|NCT01088243|O2|Outcome|Placebo|"Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.~Placebo: Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects."
362032|NCT01088243|O1|Outcome|Mesalamine|"Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.~Mesalamine: Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects."
362033|NCT01088243|O2|Outcome|Placebo|"Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.~Placebo: Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects."
362034|NCT01088243|O1|Outcome|Mesalamine|"Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.~Mesalamine: Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects."
362035|NCT01088243|O2|Outcome|Placebo|"Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.~Placebo: Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects."
362740|NCT01086215|P2|Participant Flow|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
362036|NCT01088243|O1|Outcome|Mesalamine|"Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.~Mesalamine: Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects."
362037|NCT01088243|O2|Outcome|Placebo|"Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.~Placebo: Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects."
362038|NCT01088243|O1|Outcome|Mesalamine|"Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.~Mesalamine: Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects."
362039|NCT01088243|E2|Reported Event|Placebo|"Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.~Placebo: Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects."
362040|NCT01088243|E1|Reported Event|Mesalamine|"Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.~Mesalamine: Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects."
362041|NCT01087996|B3|Baseline|Total|Total of all reporting groups
362042|NCT01087996|B2|Baseline|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
362043|NCT01087996|B1|Baseline|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
362044|NCT01087996|P2|Participant Flow|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
362045|NCT01087996|P1|Participant Flow|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
362046|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
362047|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
362048|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
362049|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
362097|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362098|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362050|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
362051|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
362052|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
362053|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
362054|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
362055|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
362056|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
362057|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
362058|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
362059|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
362099|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362100|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362060|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
362061|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
362062|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
362063|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
362064|NCT01087996|E2|Reported Event|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
362065|NCT01087996|E1|Reported Event|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
362066|NCT01087970|B1|Baseline|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
362067|NCT01087970|P1|Participant Flow|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 milligrams/square meter (mg/m²) administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin area under curve (AUC) 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
362068|NCT01087970|O1|Outcome|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
362069|NCT01087970|O1|Outcome|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
362070|NCT01087970|O1|Outcome|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
362741|NCT01086215|P1|Participant Flow|Limb Ischemia|Patients presenting with limb ischemia for treatment
362071|NCT01087970|O1|Outcome|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
362072|NCT01087970|O1|Outcome|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
362073|NCT01087970|O1|Outcome|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
362074|NCT01087970|E2|Reported Event|Cetuximab + Pemetrexed + Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
362075|NCT01087970|E1|Reported Event|Cetuximab + Pemetrexed + Carboplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
362076|NCT01087957|B3|Baseline|Total|Total of all reporting groups
362077|NCT01087957|B2|Baseline|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362078|NCT01087957|B1|Baseline|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362079|NCT01087957|P2|Participant Flow|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362080|NCT01087957|P1|Participant Flow|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362081|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362082|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362083|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362084|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362085|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362086|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362087|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362088|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362089|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362090|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362091|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362092|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362093|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362094|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362095|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362096|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
363133|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
362101|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362102|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362103|NCT01087957|E2|Reported Event|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362104|NCT01087957|E1|Reported Event|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
362105|NCT01087944|B1|Baseline|Overall|Participants received PEG-IFN alfa-2a 180 mcg SC once a week either AI or PFS for the first 3 weeks and then switched to the other method of injection for an additional 3 weeks. Participants also received ribavirin according to standard of care per the investigator’s judgment.
362106|NCT01087944|P2|Participant Flow|Sequence 2 (Pre-filled Syringe Then Auto-Injector)|Participants received PEG-IFN 180 mcg /0.5 mL subcutaneously once a week using pre-filled syringe from Week 1-3 in Treatment Period 1 and using autoinjector from Week 4-6 in Treatment Period 2.
362107|NCT01087944|P1|Participant Flow|Sequence 1 (Auto-Injector Then Pre-filled Syringe)|Participants received Peginterferon alfa-2a (PEG-IFN) 180 microgram (mcg) /0.5 milliliter (mL) subcutaneously once a week using autoinjector from Week 1-3 in Treatment Period 1 and using pre-filled syringe from Week 4-6 in Treatment Period 2.
362108|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
362109|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
362110|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
362111|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
362112|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
362113|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
362114|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
362115|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
362116|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
362117|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
362118|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
362119|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
362197|NCT01087905|E1|Reported Event|Two Weeks of Nicotine Patch Only|Participants in this treatment group received Two Weeks of Nicotine Patch Only.
362120|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
362121|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
362122|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
362123|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
362124|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
362125|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
362126|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
362127|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
362128|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
362129|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
362130|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
362131|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
362132|NCT01087944|E2|Reported Event|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
362133|NCT01087944|E1|Reported Event|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
362134|NCT01087918|B3|Baseline|Total|Total of all reporting groups
362135|NCT01087918|B2|Baseline|Strength Training First, Then Robot-assisted Gait Training|16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period.
362136|NCT01087918|B1|Baseline|Robot-assisted Gait Training First, Then Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period.
362137|NCT01087918|P2|Participant Flow|Strength Training First, Then Robot-assisted Gait Training|16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period.
362198|NCT01087814|B3|Baseline|Total|Total of all reporting groups
362138|NCT01087918|P1|Participant Flow|Robot-assisted Gait Training First, Then Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period.
362139|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
362140|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
362141|NCT01087918|O2|Outcome|First Strength Training, Then RAGT|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
362142|NCT01087918|O1|Outcome|First RAGT, Then Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
362143|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
362144|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
362145|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
362146|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
362147|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
362148|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
362149|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
362150|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
362151|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
362152|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
362153|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
362154|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
362155|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of strength training 4 times a week
362156|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week
362157|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
362158|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
362159|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
362160|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
362161|NCT01087918|E2|Reported Event|Strength Training First, Then Robot-assisted Gait Training|16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period.
362162|NCT01087918|E1|Reported Event|Robot-assisted Gait Training First, Then Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period.
362163|NCT01087905|B9|Baseline|Total|Total of all reporting groups
362164|NCT01087905|B8|Baseline|6 Weeks of Nicotine Patch+Nicotine Gum and CMAC|Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
362165|NCT01087905|B7|Baseline|6 Weeks of Nicotine Patch+Nicotine Gum , No CMAC|Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
362166|NCT01087905|B6|Baseline|6 Weeks of Nicotine Patch Only Plus CMAC|Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
362167|NCT01087905|B5|Baseline|6 Weeks of Nicotine Patch Only, No CMAC|Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
362168|NCT01087905|B4|Baseline|2 Weeks of Nicotine Patch+Nicotine Gum and CMAC|Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
362169|NCT01087905|B3|Baseline|2 Weeks of Nicotine Patch+Nicotine Gum , No CMAC|Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
362170|NCT01087905|B2|Baseline|2 Weeks of Nicotine Patch Only Plus CMAC|Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
362171|NCT01087905|B1|Baseline|2 Weeks of Nicotine Patch Only, No CMAC|Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
362172|NCT01087905|P8|Participant Flow|6 Weeks of Nicotine Patch+Nicotine Gum and CMAC|Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
362173|NCT01087905|P7|Participant Flow|6 Weeks of Nicotine Patch+Nicotine Gum , No CMAC|Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
362199|NCT01087814|B2|Baseline|Over-encapsulated Efavirenz|Both arms received both versions of the drug over the course of the study.
362174|NCT01087905|P6|Participant Flow|6 Weeks of Nicotine Patch Only Plus CMAC|Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
362175|NCT01087905|P5|Participant Flow|6 Weeks of Nicotine Patch Only, No CMAC|Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
362176|NCT01087905|P4|Participant Flow|2 Weeks of Nicotine Patch+Nicotine Gum and CMAC|Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
362177|NCT01087905|P3|Participant Flow|2 Weeks of Nicotine Patch+Nicotine Gum , No CMAC|Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
362178|NCT01087905|P2|Participant Flow|2 Weeks of Nicotine Patch Only Plus CMAC|Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
362179|NCT01087905|P1|Participant Flow|2 Weeks of Nicotine Patch Only, No CMAC|Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
362180|NCT01087905|O4|Outcome|Six Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Six Weeks of Nicotine Patch plus Nicotine Gum.
362181|NCT01087905|O3|Outcome|Six Weeks of Nicotine Patch Only|Participants in this treatment group received Six Weeks of Nicotine Patch Only.
362182|NCT01087905|O2|Outcome|Two Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Two Weeks of Nicotine Patch plus Nicotine Gum.
362183|NCT01087905|O1|Outcome|Two Weeks of Nicotine Patch Only|Participants in this treatment group received Two Weeks of Nicotine Patch Only.
362184|NCT01087905|O4|Outcome|Six Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Six Weeks of Nicotine Patch plus Nicotine Gum.
362185|NCT01087905|O3|Outcome|Six Weeks of Nicotine Patch Only|Participants in this treatment group received Six Weeks of Nicotine Patch Only.
362186|NCT01087905|O2|Outcome|Two Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Two Weeks of Nicotine Patch plus Nicotine Gum.
362187|NCT01087905|O1|Outcome|Two Weeks of Nicotine Patch Only|Participants in this treatment group received Two Weeks of Nicotine Patch Only.
362188|NCT01087905|O6|Outcome|Standard Cessation Counseling Plus CMAC)|Participants in this intervention group received standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC). This intervention is considered to be the enhanced intervention in terms of cessation counseling; it will be compared to the standard cessation counseling intervention which consists of Standard Cessation Counseling only (no CMAC). Approximately half the total sample was randomized to the standard intervention (Standard Cessation Counseling, No CMAC) and half to the enhanced intervention (Standard Cessation Counseling plus CMAC).
362189|NCT01087905|O5|Outcome|Standard Cessation Counseling (No CMAC)|Participants in this intervention group received standard quitline cessation counseling consisting of 4 proactive counseling calls. This intervention is considered to be the standard intervention in terms of cessation counseling; it will be compared to the enhanced cessation counseling intervention which consists of Standard Cessation Counseling plus Cognitive Medication Adherence Counseling (CMAC). Approximately half the total sample was randomized to the standard intervention (Standard Cessation Counseling, No CMAC) and half to the enhanced intervention (Standard Cessation Counseling plus CMAC).
362190|NCT01087905|O4|Outcome|NRT Combination Therapy (Nicotine Patch Plus Nicotine Gum)|Participants in this intervention group received Combination Nicotine Replacement Therapy (NRT) consisting of the Nicotine Patch plus Nicotine Gum. This intervention is considered to be the enhanced intervention in terms of type of NRT; it will be compared to the standard NRT type intervention which is NRT Monotherapy consisting of the Nicotine Patch Only. Approximately half the total sample was randomized to the standard intervention (Nicotine Patch Only) and half to the enhanced intervention (Nicotine Patch plus Nicotine Gum).
362191|NCT01087905|O3|Outcome|NRT Monotherapy (Nicotine Patch Only)|Participants in this intervention group received a single Nicotine Replacement Therapy (NRT) consisting of the Nicotine Patch only. This intervention is considered to be the standard intervention in terms of type of NRT; it will be compared to the enhanced NRT type intervention which is combination NRT consisting of Nicotine Patch plus Nicotine Gum (Combo NRT). Approximately half the total sample was randomized to the standard intervention (Nicotine Patch Only) and half to the enhanced intervention (Nicotine Patch plus Nicotine Gum).
362192|NCT01087905|O2|Outcome|Six Weeks of Nicotine Replacement Therapy (NRT)|Participants in this intervention group received a six-week supply of Nicotine Replacement Therapy (NRT). This intervention is considered to be the enhanced intervention in terms of duration of NRT; it will be compared to the standard NRT duration intervention which is two weeks of NRT. Approximately half the total sample was randomized to the standard intervention (two weeks of NRT) and half to the enhanced intervention (six weeks of NRT).
362193|NCT01087905|O1|Outcome|Two Weeks of Nicotine Replacement Therapy (NRT)|Participants in this intervention group received a two-week supply of Nicotine Replacement Therapy (NRT). This intervention is considered to be the standard intervention in terms of duration of NRT; it will be compared to the enhanced NRT duration intervention which is six weeks of NRT. Approximately half the total sample was randomized to the standard intervention (two weeks of NRT) and half to the enhanced intervention (six weeks of NRT).
362194|NCT01087905|E4|Reported Event|Six Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Six Weeks of Nicotine Patch plus Nicotine Gum.
362195|NCT01087905|E3|Reported Event|Six Weeks of Nicotine Patch Only|Participants in this treatment group received Six Weeks of Nicotine Patch Only.
362196|NCT01087905|E2|Reported Event|Two Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Two Weeks of Nicotine Patch plus Nicotine Gum.
363134|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
362201|NCT01087814|P2|Participant Flow|Over-encapsulated Efavirenz First, Then Efavirenz|This arm received over-encapsulated efavirenz for five days, then efavirenz for five days.
362202|NCT01087814|P1|Participant Flow|Efavirenz First, Then Over-encapsulated Efavirenz|This arm received efavirenz for five days, then over-encapsulated efavirenz for five days.
362203|NCT01087814|O2|Outcome|Over-encapsulated Efavirenz|All subjects took over-encapsulated efavirenz.
362204|NCT01087814|O1|Outcome|Efavirenz (Tablet)|All subjects took efavirenz.
362205|NCT01087814|E2|Reported Event|Over-encapsulated Efavirenz|Both arms received both versions of the drug over the course of the study.
362206|NCT01087814|E1|Reported Event|Efavirenz|Both arms received both versions of the drug during the course of the study.
362207|NCT01087801|B3|Baseline|Total|Total of all reporting groups
362208|NCT01087801|B2|Baseline|Placebo|Saline for Injection 0.1 mL/kg IV
362209|NCT01087801|B1|Baseline|ChiRhoStim|Human Secretin for Injection 0.1 mL/kg IV
362210|NCT01087801|P2|Participant Flow|Placebo|Saline for Injection 0.1 mL/kg IV
362211|NCT01087801|P1|Participant Flow|ChiRhoStim|Human Secretin for Injection 0.1 mL/kg IV
362212|NCT01087801|O2|Outcome|Placebo|Saline for Injection 0.1 mL/kg IV
362213|NCT01087801|O1|Outcome|ChiRhoStim|Human Secretin for Injection 0.1 mL/kg IV
362214|NCT01087801|E2|Reported Event|Placebo|Saline for Injection 0.1 mL/kg IV
362215|NCT01087801|E1|Reported Event|ChiRhoStim|Human Secretin for Injection 0.1 mL/kg IV
362216|NCT01087788|B4|Baseline|Total Title|
362217|NCT01087788|B3|Baseline|CZP 400 mg Q4W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
362218|NCT01087788|B2|Baseline|CZP 200 mg Q2W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
362219|NCT01087788|B1|Baseline|Placebo|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
362220|NCT01087788|P3|Participant Flow|CZP 400 mg Q4W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
362221|NCT01087788|P2|Participant Flow|CZP 200 mg Q2W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
362222|NCT01087788|P1|Participant Flow|Placebo|"Matching Placebo (PBO) to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
362223|NCT01087788|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)|"This combined group includes subjects of the two treatment arms CZP 200 mg Q2W and CZP 400 mg Q4W used in some analyses.~Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind."
362224|NCT01087788|O3|Outcome|CZP 400 mg Q4W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
362225|NCT01087788|O2|Outcome|CZP 200 mg Q2W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
362226|NCT01087788|O1|Outcome|Placebo (Randomized Set)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
362227|NCT01087788|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)|"This combined group includes subjects of the two treatment arms CZP 200 mg Q2W and CZP 400 mg Q4W used in some analyses.~Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind."
362228|NCT01087788|O3|Outcome|CZP 400 mg Q4W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
362229|NCT01087788|O2|Outcome|CZP 200 mg Q2W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
362230|NCT01087788|O1|Outcome|Placebo (Randomized Set)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
362231|NCT01087788|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)|"This combined group includes subjects of the two treatment arms CZP 200 mg Q2W and CZP 400 mg Q4W used in some analyses.~Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind."
362232|NCT01087788|O3|Outcome|CZP 400 mg Q4W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
362233|NCT01087788|O2|Outcome|CZP 200 mg Q2W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
362234|NCT01087788|O1|Outcome|Placebo (Randomized Set)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
362235|NCT01087788|O3|Outcome|CZP 400 mg Q4W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
362236|NCT01087788|O2|Outcome|CZP 200 mg Q2W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
362237|NCT01087788|O1|Outcome|Placebo (Randomized Set)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
362238|NCT01087788|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)|"This combined group includes subjects of the two treatment arms CZP 200 mg Q2W and CZP 400 mg Q4W used in some analyses.~Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind."
362239|NCT01087788|O3|Outcome|CZP 400 mg Q4W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
362240|NCT01087788|O2|Outcome|CZP 200 mg Q2W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
362241|NCT01087788|O1|Outcome|Placebo (Randomized Set)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
362242|NCT01087788|O3|Outcome|CZP 400 mg Q4W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
362243|NCT01087788|O2|Outcome|CZP 200 mg Q2W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
362244|NCT01087788|O1|Outcome|Placebo (Randomized Set)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
362245|NCT01087788|E3|Reported Event|All CZP 200 mg + 400 mg|This arm shows all patients treated with Certolizumab Pegol (CZP) at least once. Hence, this arm is a combination of arm All CZP 200 mg Q2W and arm All CZP 400 mg Q4W.
362246|NCT01087788|E2|Reported Event|All CZP 400 mg Q4W|"This arm includes all subjects who were randomized to CZP 400 mg Q4W at Baseline and those subjects who escaped or were re-randomized from Placebo to CZP 400 mg Q4W.~Subjects received two injections of Placebo every four weeks in between the two injections of 200 mg CZP to maintain the study blind."
362247|NCT01087788|E1|Reported Event|All CZP 200 mg Q2W|"This arm includes all subjects who were randomized to CZP 200 mg Q2W at Baseline and those subjects who escaped or were re-randomized from Placebo to CZP 200 mg Q2W.~Subjects received one injection of 200 mg CZP and one injection of Placebo every two weeks to maintain the study blind."
362248|NCT01087762|B4|Baseline|Total Title|
362249|NCT01087762|B3|Baseline|CZP 400 mg Q4W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
362382|NCT01087489|B1|Baseline|All Study Participants|Each participant was randomly assigned to receive either anesthetic preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day.
363135|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
362250|NCT01087762|B2|Baseline|CZP 200 mg Q2W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
362251|NCT01087762|B1|Baseline|Placebo|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
362252|NCT01087762|P5|Participant Flow|All CZP 400 mg|"All subjects who received CZP at the specified dose (400 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
362253|NCT01087762|P4|Participant Flow|All CZP 200 mg|"All subjects who received CZP at the specified dose (200 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
362254|NCT01087762|P3|Participant Flow|CZP 400 mg Q4W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
362255|NCT01087762|P2|Participant Flow|CZP 200 mg Q2W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
362256|NCT01087762|P1|Participant Flow|Placebo|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
362257|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
362258|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
362259|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
362260|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
362261|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
362262|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
362263|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
362264|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
362383|NCT01087489|P2|Participant Flow|Unilateral|Each participant was randomly assigned to receive an intravitreal injection with 4% lidocaine prep on one visit and 3.5% lidocaine gel on the next visit.
363136|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
362265|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
362266|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
362267|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
362268|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
362269|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
362270|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
362271|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
362272|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
362273|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
362274|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
362275|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
362276|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
362277|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
362278|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
362384|NCT01087489|P1|Participant Flow|Bilateral|Participants were given bilateral injections with 4% lidocaine prep in one eye and 3.5% lidocaine gel in the other.
363137|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
362279|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
362280|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
362281|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
362282|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
362283|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
362284|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
362285|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
362286|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
362287|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
362288|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
362289|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
362290|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
362291|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
362292|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
362311|NCT01087736|E1|Reported Event|Topiramate|Topiramate: topiramate titrated up over 5 weeks, beginning at 25 mg per day, and increased in the second week to 25 mg twice per day; in the third week to 50 mg twice/day; in the fourth week to 75 mg twice/day; in the 5th week to 100 mg twice/day; and in weeks 6-11 increased to and maintained at 100 mg in the morning and 200 mg at night. Upon completing the 6 week maintenance period dosage was tapered off over a 7-day period (Week 12).
362293|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
362294|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
362295|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
362296|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
362297|NCT01087762|E4|Reported Event|Placebo|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
362298|NCT01087762|E3|Reported Event|All CZP 200 mg + 400 mg|This arm shows all patients treated with Certolizumab Pegol (CZP) at least once. Hence, this arm is a combination of arm All CZP 200 mg and arm All CZP 400 mg.
362299|NCT01087762|E2|Reported Event|All CZP 400 mg (Safety Analysis)|"All subjects who received CZP at the specified dose (400 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
362300|NCT01087762|E1|Reported Event|All CZP 200 mg (Safety Analysis)|"All subjects who received CZP at the specified dose (200 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
362301|NCT01087736|B3|Baseline|Total|Total of all reporting groups
362302|NCT01087736|B2|Baseline|Placebo|Placebo: Placebo pills prepared by the UCSF pharmacy were indistinguishable from the topiramate pills used in that arm. The dosing of placebo pills followed the same regimen as outlined for the topiramate arm. In the event of a safety issue, there would be a procedure for unblinding only that participant.
362303|NCT01087736|B1|Baseline|Topiramate|Topiramate: topiramate titrated up over 5 weeks, beginning at 25 mg per day, and increased in the second week to 25 mg twice per day; in the third week to 50 mg twice/day; in the fourth week to 75 mg twice/day; in the 5th week to 100 mg twice/day; and in weeks 6-11 increased to and maintained at 100 mg in the morning and 200 mg at night. Upon completing the 6 week maintenance period dosage was tapered off over a 7-day period (Week 12).
362304|NCT01087736|P2|Participant Flow|Placebo|Placebo: Placebo pills prepared by the UCSF pharmacy were indistinguishable from the topiramate pills used in that arm. The dosing of placebo pills followed the same regimen as outlined for the topiramate arm. In the event of a safety issue, there would be a procedure for unblinding only that participant.
362305|NCT01087736|P1|Participant Flow|Topiramate|Topiramate: topiramate titrated up over 5 weeks, beginning at 25 mg per day, and increased in the second week to 25 mg twice per day; in the third week to 50 mg twice/day; in the fourth week to 75 mg twice/day; in the 5th week to 100 mg twice/day; and in weeks 6-11 increased to and maintained at 100 mg in the morning and 200 mg at night. Upon completing the 6 week maintenance period dosage was tapered off over a 7-day period (Week 12).
362306|NCT01087736|O2|Outcome|Placebo|Placebo: Placebo pills prepared by the UCSF pharmacy were indistinguishable from the topiramate pills used in that arm. The dosing of placebo pills followed the same regimen as outlined for the topiramate arm. In the event of a safety issue, there would be a procedure for unblinding only that participant.
362307|NCT01087736|O1|Outcome|Topiramate|Topiramate: topiramate titrated up over 5 weeks, beginning at 25 mg per day, and increased in the second week to 25 mg twice per day; in the third week to 50 mg twice/day; in the fourth week to 75 mg twice/day; in the 5th week to 100 mg twice/day; and in weeks 6-11 increased to and maintained at 100 mg in the morning and 200 mg at night. Upon completing the 6 week maintenance period dosage was tapered off over a 7-day period (Week 12).
362308|NCT01087736|O2|Outcome|Placebo|Placebo: Placebo pills prepared by the UCSF pharmacy were indistinguishable from the topiramate pills used in that arm. The dosing of placebo pills followed the same regimen as outlined for the topiramate arm. In the event of a safety issue, there would be a procedure for unblinding only that participant.
362309|NCT01087736|O1|Outcome|Topiramate|Topiramate: topiramate titrated up over 5 weeks, beginning at 25 mg per day, and increased in the second week to 25 mg twice per day; in the third week to 50 mg twice/day; in the fourth week to 75 mg twice/day; in the 5th week to 100 mg twice/day; and in weeks 6-11 increased to and maintained at 100 mg in the morning and 200 mg at night. Upon completing the 6 week maintenance period dosage was tapered off over a 7-day period (Week 12).
362310|NCT01087736|E2|Reported Event|Placebo|Placebo: Placebo pills prepared by the UCSF pharmacy were indistinguishable from the topiramate pills used in that arm. The dosing of placebo pills followed the same regimen as outlined for the topiramate arm. In the event of a safety issue, there would be a procedure for unblinding only that participant.
362312|NCT01087723|B3|Baseline|Total|Total of all reporting groups
363138|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
362313|NCT01087723|B2|Baseline|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
362314|NCT01087723|B1|Baseline|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
362315|NCT01087723|P2|Participant Flow|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of ST segment elevation acute coronary syndrome (STE-ACS ), not including bivalirudin: unfractionated heparin (UFH) (100 international units/kg [IU/kg] without glycoprotein IIb/IIIa inhibitor [GPI] and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-micrograms/kilogram [μg/kg] IV boluses with a 10-minute [min] interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or low molecular weight heparin (LMWH) with or without GPI and is referred to as heparins with optional GPI.”"
362316|NCT01087723|P1|Participant Flow|Bivalirudin|Given immediately upon enrolment as an intravenous (IV) bolus of 0.75 milligrams/kilogram (mg/kg), followed immediately by an infusion of 1.75 mg/kg/hour (mg/kg/h). This infusion was to be run continuously until completion of percutaneous coronary intervention (PCI), at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
362317|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
362318|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
362319|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
362320|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
362321|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
362322|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
362323|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
362473|NCT01086761|E1|Reported Event|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
362324|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
362325|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
362326|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
362327|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
362328|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
362329|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
362330|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
362331|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
362332|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
362333|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
362334|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
362335|NCT01087723|E2|Reported Event|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
362336|NCT01087723|E1|Reported Event|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
362337|NCT01087541|B3|Baseline|Total|Total of all reporting groups
362338|NCT01087541|B2|Baseline|Control Group|Usual healthcare of diabetics patients
362339|NCT01087541|B1|Baseline|Intervention|Behavioural program of education for health professionals of the study
362340|NCT01087541|P2|Participant Flow|Control Group|Usual healthcare of diabetics patients
362341|NCT01087541|P1|Participant Flow|Intervention|Behavioural program of education for health professionals of the study
362342|NCT01087541|O2|Outcome|Control Group|Usual healthcare of diabetics patients
362343|NCT01087541|O1|Outcome|Intervention|Behavioural program of education for health professionals of the study
362344|NCT01087541|O2|Outcome|Control Group|Usual healthcare of diabetics patients
362345|NCT01087541|O1|Outcome|Intervention|Behavioural program of education for health professionals of the study
362346|NCT01087541|O2|Outcome|Control Group|Usual healthcare of diabetics patients
362347|NCT01087541|O1|Outcome|Intervention|Behavioural program of education for health professionals of the study
362348|NCT01087541|O2|Outcome|Control Group|Usual healthcare of diabetics patients
362349|NCT01087541|O1|Outcome|Intervention|Behavioural program of education for health professionals of the study
362350|NCT01087541|O2|Outcome|Control Group|Usual healthcare of diabetics patients
362351|NCT01087541|O1|Outcome|Intervention|Behavioural program of education for health professionals of the study
362352|NCT01087541|O2|Outcome|Control Group|Usual healthcare of diabetics patients
362353|NCT01087541|O1|Outcome|Intervention|Behavioural program of education for health professionals of the study
362354|NCT01087541|E2|Reported Event|Control Group|Usual healthcare
362355|NCT01087541|E1|Reported Event|Intervention Group|Intervention group: educational program
362356|NCT01087528|B1|Baseline|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison.."
362357|NCT01087528|P1|Participant Flow|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison.."
362358|NCT01087528|O1|Outcome|PillCam COLON|Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.
362359|NCT01087528|E1|Reported Event|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison.."
362360|NCT01087502|B3|Baseline|Total|Total of all reporting groups
362361|NCT01087502|B2|Baseline|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
362362|NCT01087502|B1|Baseline|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
362363|NCT01087502|P2|Participant Flow|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
362364|NCT01087502|P1|Participant Flow|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
362365|NCT01087502|O1|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
362366|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
362367|NCT01087502|O1|Outcome|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
362368|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
362369|NCT01087502|O1|Outcome|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
362370|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
362371|NCT01087502|O1|Outcome|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
362372|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
362373|NCT01087502|O1|Outcome|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
362374|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
362375|NCT01087502|O1|Outcome|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
362376|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
362377|NCT01087502|O1|Outcome|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
362378|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
362379|NCT01087502|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
362380|NCT01087502|E2|Reported Event|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
362381|NCT01087502|E1|Reported Event|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
362474|NCT01086605|B3|Baseline|Total|Total of all reporting groups
363139|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
363140|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
362385|NCT01087489|O2|Outcome|3.5% Ophthalmic Lidocaine Gel|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3.5% ophthalmic lidocaine gel to the injection site.
362386|NCT01087489|O1|Outcome|4% Liquid Lidocaine Method|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3 cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of injection.
362387|NCT01087489|O2|Outcome|3.5% Ophthalmic Lidocaine Gel|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3.5% ophthalmic lidocaine gel to the injection site.
362388|NCT01087489|O1|Outcome|4% Liquid Lidocaine Method|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3 cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of injection.
362389|NCT01087489|O2|Outcome|3.5% Ophthalmic Lidocaine Gel|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3.5% ophthalmic lidocaine gel to the injection site.
362390|NCT01087489|O1|Outcome|4% Liquid Lidocaine Method|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3 cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of injection.
362391|NCT01087489|E2|Reported Event|3.5% Ophthalmic Lidocaine Gel|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3.5% ophthalmic lidocaine gel to the injection site.
362392|NCT01087489|E1|Reported Event|4% Liquid Lidocaine Method|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3 cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of injection.
362393|NCT01086969|B4|Baseline|Total|Total of all reporting groups
362394|NCT01086969|B3|Baseline|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
362395|NCT01086969|B2|Baseline|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
362396|NCT01086969|B1|Baseline|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
362397|NCT01086969|P3|Participant Flow|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
362398|NCT01086969|P2|Participant Flow|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
362399|NCT01086969|P1|Participant Flow|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
362400|NCT01086969|O3|Outcome|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
362401|NCT01086969|O2|Outcome|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
362402|NCT01086969|O1|Outcome|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
362403|NCT01086969|O3|Outcome|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
362404|NCT01086969|O2|Outcome|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
362405|NCT01086969|O1|Outcome|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
362406|NCT01086969|O3|Outcome|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
362407|NCT01086969|O2|Outcome|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
362408|NCT01086969|O1|Outcome|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
362409|NCT01086969|O3|Outcome|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
362410|NCT01086969|O2|Outcome|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
362411|NCT01086969|O1|Outcome|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
362412|NCT01086969|E3|Reported Event|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
362413|NCT01086969|E2|Reported Event|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
362414|NCT01086969|E1|Reported Event|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
362415|NCT01086852|B1|Baseline|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
362416|NCT01086852|P1|Participant Flow|Active Treatment With FACTOR X|Four subjects underwent 4 major surgeries with active treatment (FACTOR X)
362417|NCT01086852|O1|Outcome|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
362418|NCT01086852|O1|Outcome|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
362419|NCT01086852|O1|Outcome|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
362420|NCT01086852|O1|Outcome|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
362421|NCT01086852|O1|Outcome|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
362422|NCT01086852|O1|Outcome|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
362475|NCT01086605|B2|Baseline|Arm II/Group B (Pixantrone IV Days 1, 8, and 15)|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
362423|NCT01086852|O1|Outcome|FACTOR X|"Human Coagulation Factor X~FACTOR X: Presurgery loading dose- The FX level of 70%-90% should be achieved.This will be calculated based on the patients weight on day of surgery and the required rise. Initial dose should not exceed 60IU/kg.~Post surgery- FX trough levels of 50% should be achieved.~Intravenous infusion of factor X is given at a suggested rate of 10mL/min but not exceeding more than 20mL/min."
362424|NCT01086852|O1|Outcome|FACTOR X|"Human Coagulation Factor X~FACTOR X: Presurgery loading dose- The FX level of 70%-90% should be achieved.This will be calculated based on the patients weight on day of surgery and the required rise. Initial dose should not exceed 60IU/kg.~Post surgery- FX trough levels of 50% should be achieved.~Intravenous infusion of factor X is given at a suggested rate of 10mL/min but not exceeding more than 20mL/min."
362425|NCT01086852|E1|Reported Event|FACTOR X|"Human Coagulation Factor X~FACTOR X: Presurgery loading dose- The FX level of 70%-90% should be achieved.This will be calculated based on the patients weight on day of surgery and the required rise. Initial dose should not exceed 60IU/kg.~Post surgery- FX trough levels of 50% should be achieved.~Intravenous infusion of factor X is given at a suggested rate of 10mL/min but not exceeding more than 20mL/min."
362426|NCT01086761|B6|Baseline|Total|Total of all reporting groups
362427|NCT01086761|B5|Baseline|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
362428|NCT01086761|B4|Baseline|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
362429|NCT01086761|B3|Baseline|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
362430|NCT01086761|B2|Baseline|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
362431|NCT01086761|B1|Baseline|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
362432|NCT01086761|P6|Participant Flow|MP0112 (3.6 mg)|Single 3.6 mg intravitreal injection of MP0112 in the study eye.
362433|NCT01086761|P5|Participant Flow|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
362434|NCT01086761|P4|Participant Flow|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
362435|NCT01086761|P3|Participant Flow|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
362436|NCT01086761|P2|Participant Flow|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
362437|NCT01086761|P1|Participant Flow|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
362438|NCT01086761|O5|Outcome|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
362439|NCT01086761|O4|Outcome|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
362440|NCT01086761|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
362441|NCT01086761|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
362442|NCT01086761|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
362443|NCT01086761|O5|Outcome|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
362444|NCT01086761|O4|Outcome|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
362445|NCT01086761|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
362446|NCT01086761|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
362447|NCT01086761|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
362448|NCT01086761|O5|Outcome|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
362449|NCT01086761|O4|Outcome|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
362450|NCT01086761|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
362451|NCT01086761|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
362452|NCT01086761|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
362453|NCT01086761|O5|Outcome|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
362454|NCT01086761|O4|Outcome|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
362455|NCT01086761|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
362456|NCT01086761|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
362457|NCT01086761|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
362458|NCT01086761|O5|Outcome|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
362459|NCT01086761|O4|Outcome|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
362460|NCT01086761|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
362461|NCT01086761|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
362462|NCT01086761|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
362463|NCT01086761|O5|Outcome|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
362464|NCT01086761|O4|Outcome|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
362465|NCT01086761|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
362466|NCT01086761|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
362467|NCT01086761|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
362468|NCT01086761|O1|Outcome|MP0112|Single intravitreal injection of MP0112 in the study eye of one of the following doses: 0.04 mg, 0.15 mg, 0.4 mg, 1.0 mg or 2.0 mg.
362469|NCT01086761|E5|Reported Event|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
362470|NCT01086761|E4|Reported Event|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
362471|NCT01086761|E3|Reported Event|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
362472|NCT01086761|E2|Reported Event|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
362476|NCT01086605|B1|Baseline|Arm I/Group A (Pixantrone IV Day 1)|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
362477|NCT01086605|P2|Participant Flow|Arm II/Group B (Pixantrone IV Days 1, 8, and 15)|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
362478|NCT01086605|P1|Participant Flow|Arm I/Group A (Pixantrone IV Day 1)|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
362479|NCT01086605|O2|Outcome|Arm II/Group B (Pixantrone IV Days 1, 8, and 15)|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
362480|NCT01086605|O1|Outcome|Arm I/Group A (Pixantrone IV Day 1)|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
362481|NCT01086605|O1|Outcome|Arm I/Group A + Arm II/Group B|"Arm I/Group A: Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Arm II/Group B: Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity."
362482|NCT01086605|O2|Outcome|Arm II/Group B (Pixantrone IV Days 1, 8, and 15)|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
362483|NCT01086605|O1|Outcome|Arm I/Group A (Pixantrone IV Day 1)|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
362484|NCT01086605|O2|Outcome|Arm II/Group B (Pixantrone IV Days 1, 8, and 15)|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
362485|NCT01086605|O1|Outcome|Arm I/Group A (Pixantrone IV Day 1)|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
362486|NCT01086605|O2|Outcome|Arm II/Group B (Pixantrone IV Days 1, 8, and 15)|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
362487|NCT01086605|O1|Outcome|Arm I/Group A (Pixantrone IV Day 1)|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
362488|NCT01086605|O2|Outcome|Arm II/Group B (Pixantrone IV Days 1, 8, and 15)|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
362489|NCT01086605|O1|Outcome|Arm I/Group A (Pixantrone IV Day 1)|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
362490|NCT01086605|E2|Reported Event|Arm II/Group B|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
362491|NCT01086605|E1|Reported Event|Arm I/Group A|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
362492|NCT01086475|B3|Baseline|Total|Total of all reporting groups
362493|NCT01086475|B2|Baseline|Placebo|"Subjects randomized to placebo arm will receive placebo pill 30 minutes prior to each of ten Social Skills Training Sessions~Placebo: Placebo pill administered 30 minutes prior to each of the ten Social Skill Training Sessions"
362494|NCT01086475|B1|Baseline|D-cycloserine|"Subjects randomized to D-cycloserine will be administered 50 mg 30 minutes prior to each of ten Social Skills Training Sessions~D-cycloserine: 50 mg dose administered 30 minutes prior to each of the ten Social Skill Training Sessions"
362495|NCT01086475|P2|Participant Flow|Placebo|Subjects who received placebo
362496|NCT01086475|P1|Participant Flow|D-cycloserine|Subjects who received d-cycloserine
362497|NCT01086475|O2|Outcome|Placebo|Subjects who received placebo
362498|NCT01086475|O1|Outcome|D-cycloserine|Subjects who received d-cycloserine
362499|NCT01086475|O2|Outcome|Placebo|Subjects who received placebo
362500|NCT01086475|O1|Outcome|D-cycloserine|Subjects who received d-cycloserine
362501|NCT01086475|O2|Outcome|Placebo|Subjects who received placebo
362502|NCT01086475|O1|Outcome|D-cycloserine|Subjects who received d-cycloserine
362503|NCT01086475|E2|Reported Event|Placebo|Subjects who received placebo
362504|NCT01086475|E1|Reported Event|D-cycloserine|Subjects who received d-cycloserine
362505|NCT01086423|B4|Baseline|Total|Total of all reporting groups
362506|NCT01086423|B3|Baseline|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
362507|NCT01086423|B2|Baseline|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
362508|NCT01086423|B1|Baseline|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
363141|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
362509|NCT01086423|P3|Participant Flow|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
362510|NCT01086423|P2|Participant Flow|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
362511|NCT01086423|P1|Participant Flow|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
362512|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
362513|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
362514|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
362515|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
362516|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
362517|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
362518|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
362519|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
362520|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
362521|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
362522|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
362523|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
362524|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
362525|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
362526|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
362527|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
362528|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
362529|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
362530|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
362531|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
362532|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
362533|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
362534|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
362535|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
362536|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
362537|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
362538|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
362539|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
362540|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
362541|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
362542|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
362543|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
362544|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
362545|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
362546|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
362547|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
362548|NCT01086423|E3|Reported Event|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
362549|NCT01086423|E2|Reported Event|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
362550|NCT01086423|E1|Reported Event|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
362551|NCT01086410|B5|Baseline|Total|Total of all reporting groups
362552|NCT01086410|B4|Baseline|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
362738|NCT01086215|P4|Participant Flow|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
362553|NCT01086410|B3|Baseline|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362554|NCT01086410|B2|Baseline|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362555|NCT01086410|B1|Baseline|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
362556|NCT01086410|P4|Participant Flow|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
362557|NCT01086410|P3|Participant Flow|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362558|NCT01086410|P2|Participant Flow|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362559|NCT01086410|P1|Participant Flow|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
362560|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
362561|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362562|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362563|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
362564|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
362565|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362566|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362567|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
362568|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
362569|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362570|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362571|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
362572|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
362573|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362574|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362575|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
362576|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
362577|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362578|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362579|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
362580|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
362581|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362582|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362583|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
362584|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
362585|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362586|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362587|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
362588|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
363142|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
362589|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362590|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362591|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
362592|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
362593|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362594|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362595|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
362596|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
362597|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362598|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362599|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
362600|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
362601|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362602|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362603|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
362604|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
362605|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362606|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362607|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
362608|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
362609|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362610|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362611|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
362612|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
362613|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362614|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362615|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
362616|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
362617|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362618|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362619|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
362620|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
362621|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362622|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362623|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
362624|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
363143|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
362625|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362626|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362627|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
362628|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
362629|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362630|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362631|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
362632|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
362633|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362634|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362635|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
362636|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
362637|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362638|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362639|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
362640|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
362641|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362642|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362643|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
362644|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
362645|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362646|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362647|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
362648|NCT01086410|E4|Reported Event|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
362649|NCT01086410|E3|Reported Event|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362650|NCT01086410|E2|Reported Event|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
362651|NCT01086410|E1|Reported Event|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
362652|NCT01086384|B3|Baseline|Total|Total of all reporting groups
362653|NCT01086384|B2|Baseline|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
362654|NCT01086384|B1|Baseline|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
362655|NCT01086384|P3|Participant Flow|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
362656|NCT01086384|P2|Participant Flow|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
362657|NCT01086384|P1|Participant Flow|FP 250 µg/ICS|Japanese participants using fluticasone propionate (FP)/salmeterol 250/50 micrograms (µg) twice daily received open-label FP 250 µg to ensure they continued their inhaled corticosteroid (ICS) therapy at a fixed dose during the 2-week Run-in Period. All other participants continued to use their current ICS therapy at a fixed dose during the 2-week Run-in Period. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Run-in Period.
362658|NCT01086384|O2|Outcome|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
362659|NCT01086384|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
362660|NCT01086384|O2|Outcome|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
362661|NCT01086384|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
362662|NCT01086384|O2|Outcome|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
362663|NCT01086384|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
362664|NCT01086384|E2|Reported Event|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
362665|NCT01086384|E1|Reported Event|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
362666|NCT01086358|B1|Baseline|All Completed Study Participants|"Participants received their usual prescribed triptan or Treximet, depending on the randomization schedule.~Usual prescribed triptan: usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan"
362667|NCT01086358|P2|Participant Flow|Treximet Arm First|"Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule.~Treximet for migraine treatment: Treximet is the combination of sumatriptan 85 mg plus naproxen sodium 500mg. To account for the correlation from patients acting as their own controls in this crossover design, a standard deviation of the difference equal to 2.5 is assumed. Under these assumptions, a total sample of 760, with 30 in each sequence, would power the study at 86%."
362668|NCT01086358|P1|Participant Flow|Usual Prescribed Triptan First|Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule. To account for the correlation from patients acting as their own controls in this crossover design, a standard deviation of the difference equal to 2.5 is assumed. Under these assumptions, a total sample of 60, with 30 in each sequence, would power the study at 86%.
362669|NCT01086358|O2|Outcome|Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm|"Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule.~Arm 2 - Sumatriptan/naproxen sodium (Treximet): Treximet is the combination of sumatriptan 85 mg plus naproxen sodium 500mg"
362670|NCT01086358|O1|Outcome|Arm 1 - Triptan|"Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule.~Arm 1 Triptan: Usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan"
362671|NCT01086358|O2|Outcome|Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm|"Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule.~Arm 2 - Sumatriptan/naproxen sodium (Treximet): Treximet is the combination of sumatriptan 85 mg plus naproxen sodium 500mg"
362672|NCT01086358|O1|Outcome|Arm 1 - Triptan|"Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule.~Arm 1 Triptan: Usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan"
362673|NCT01086358|O2|Outcome|Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm|"Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule.~Arm 2 - Sumatriptan/naproxen sodium (Treximet): Treximet is the combination of sumatriptan 85 mg plus naproxen sodium 500mg"
362674|NCT01086358|O1|Outcome|Arm 1 - Triptan|"Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule.~Arm 1 Triptan: Usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan"
362675|NCT01086358|O2|Outcome|Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm|"Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule.~Arm 2 - Sumatriptan/naproxen sodium (Treximet): Treximet is the combination of sumatriptan 85 mg plus naproxen sodium 500mg"
362676|NCT01086358|O1|Outcome|Arm 1 - Triptan|"Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule.~Arm 1 Triptan: Usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan"
362677|NCT01086358|E2|Reported Event|Treximet Arm|"Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule.~Treximet for migraine treatment: Treximet is the combination of sumatriptan 85 mg plus naproxen sodium 500mg. To account for the correlation from patients acting as their own controls in this crossover design, a standard deviation of the difference equal to 2.5 is assumed. Under these assumptions, a total sample of 760, with 30 in each sequence, would power the study at 86%."
362678|NCT01086358|E1|Reported Event|Usual Prescribed Triptan|Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule. To account for the correlation from patients acting as their own controls in this crossover design, a standard deviation of the difference equal to 2.5 is assumed. Under these assumptions, a total sample of 760, with 30 in each sequence, would power the study at 86%.
362679|NCT01086228|B1|Baseline|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362680|NCT01086228|P1|Participant Flow|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362681|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
363144|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
362682|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362683|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362684|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362685|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362686|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362687|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362688|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362689|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362690|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362691|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362692|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362693|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362694|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362695|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362696|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362697|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362698|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362699|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362700|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362701|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362702|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362703|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362704|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362705|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362706|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362707|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362708|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362709|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362710|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362711|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362712|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362713|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362714|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362715|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362716|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362717|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362718|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362719|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362720|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362721|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362722|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362723|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362724|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362725|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362726|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362727|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362728|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362729|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362730|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362731|NCT01086228|O1|Outcome|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362732|NCT01086228|E1|Reported Event|XIENCE V / PROMUS Stent|"Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.~XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure."
362733|NCT01086215|B5|Baseline|Total|Total of all reporting groups
362734|NCT01086215|B4|Baseline|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
362735|NCT01086215|B3|Baseline|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
362736|NCT01086215|B2|Baseline|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
362737|NCT01086215|B1|Baseline|Limb Ischemia|Patients presenting with limb ischemia for treatment
362739|NCT01086215|P3|Participant Flow|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
362742|NCT01086215|O4|Outcome|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
362743|NCT01086215|O3|Outcome|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
362744|NCT01086215|O2|Outcome|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
362745|NCT01086215|O1|Outcome|Limb Ischemia|Patients presenting with limb ischemia for treatment
362746|NCT01086215|O4|Outcome|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
362747|NCT01086215|O3|Outcome|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
362748|NCT01086215|O2|Outcome|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
362749|NCT01086215|O1|Outcome|Limb Ischemia|Patients presenting with limb ischemia for treatment
362750|NCT01086215|O4|Outcome|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
362751|NCT01086215|O3|Outcome|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
362752|NCT01086215|O2|Outcome|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
362753|NCT01086215|O1|Outcome|Limb Ischemia|Patients presenting with limb ischemia for treatment
362754|NCT01086215|E4|Reported Event|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
362755|NCT01086215|E3|Reported Event|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
362756|NCT01086215|E2|Reported Event|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
362757|NCT01086215|E1|Reported Event|Limb Ischemia|Patients presenting with limb ischemia for treatment
362758|NCT01086033|B1|Baseline|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
362759|NCT01086033|P1|Participant Flow|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
362760|NCT01086033|O1|Outcome|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
362761|NCT01086033|O1|Outcome|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
362762|NCT01086033|O1|Outcome|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
362763|NCT01086033|O1|Outcome|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
362764|NCT01086033|O3|Outcome|No Response|Rheumatoid Arthritis patients treated with Humira (adalimumab) with No Response according to EULAR criteria.
362765|NCT01086033|O2|Outcome|Moderate Response|Rheumatoid Arthritis patients treated with Humira (adalimumab) with a Moderate Response per EULAR criteria.
362766|NCT01086033|O1|Outcome|Good Response|Rheumatoid Arthritis patients treated with Humira (adalimumab) with a Good Response per EULAR criteria.
362767|NCT01086033|O1|Outcome|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
362768|NCT01086033|O1|Outcome|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
362769|NCT01086033|E1|Reported Event|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
362770|NCT01085968|B3|Baseline|Total|Total of all reporting groups
362771|NCT01085968|B2|Baseline|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
362772|NCT01085968|B1|Baseline|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
362773|NCT01085968|P2|Participant Flow|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
362774|NCT01085968|P1|Participant Flow|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
362775|NCT01085968|O2|Outcome|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
362776|NCT01085968|O1|Outcome|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
362777|NCT01085968|O2|Outcome|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
362778|NCT01085968|O1|Outcome|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
363032|NCT01085201|O4|Outcome|Stage 3|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
362779|NCT01085968|O2|Outcome|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
362780|NCT01085968|O1|Outcome|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
362781|NCT01085968|O2|Outcome|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
362782|NCT01085968|O1|Outcome|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
362783|NCT01085968|O2|Outcome|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
362784|NCT01085968|O1|Outcome|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
362785|NCT01085968|E2|Reported Event|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
362786|NCT01085968|E1|Reported Event|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
362787|NCT01085903|B3|Baseline|Total|Total of all reporting groups
362788|NCT01085903|B2|Baseline|Stroke Subjects|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline, CPS, and Post CPS and then are randomized to modafinil or placebo.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition. Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
362789|NCT01085903|B1|Baseline|Normal Subjects|"Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition."
362790|NCT01085903|P3|Participant Flow|Stroke Subjects: Modafinil Then Placebo|"Denotes sequence Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition."
362791|NCT01085903|P2|Participant Flow|Stroke Subjects: Placebo Then Modafinil|"Denotes sequence Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition."
362792|NCT01085903|P1|Participant Flow|Normal Subjects Baseline|"Normal subjects are persons without stroke who receive baseline, Cold Pressor Stimulation (CPS), Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition."
362793|NCT01085903|O5|Outcome|Stroke Subjects Placebo vs Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patientseal for three days administered only to stroke patients"
362794|NCT01085903|O4|Outcome|Stroke Subjects: Placebo|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
362795|NCT01085903|O3|Outcome|Stroke Subjects: Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients"
362796|NCT01085903|O2|Outcome|Stroke Subjects: Baseline vs CPS|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
362797|NCT01085903|O1|Outcome|Normal Subjects: Baseline vs CPS|"Normal subjects are persons without stroke who receive baseline and CPS conditions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
363145|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
362798|NCT01085903|O5|Outcome|Stroke Subjects Placebo vs Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
362799|NCT01085903|O4|Outcome|Stroke Subjects: Placebo|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
362800|NCT01085903|O3|Outcome|Stroke Subjects: Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients"
362801|NCT01085903|O2|Outcome|Stroke Subjects: Baseline vs CPS|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
362802|NCT01085903|O1|Outcome|Normal Subjects: Baseline vs CPS|"Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
362803|NCT01085903|O5|Outcome|Stroke Subjects Placebo vs Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
362804|NCT01085903|O4|Outcome|Stroke Subjects: Placebo|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
362805|NCT01085903|O3|Outcome|Stroke Subjects: Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients"
362806|NCT01085903|O2|Outcome|Stroke Subjects: Baseline vs CPS|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
362807|NCT01085903|O1|Outcome|Normal Subjects: Baseline vs CPS|"Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
362808|NCT01085903|O5|Outcome|Stroke Subjects Placebo vs Modafinil|"Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients"
362809|NCT01085903|O4|Outcome|Stroke Subjects: Placebo|Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients
362810|NCT01085903|O3|Outcome|Stroke Subjects: Modafinil|Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients
362811|NCT01085903|O2|Outcome|Stroke Subjects: Baseline vs CPS|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive modafinil, placebo, baseline, CPS, Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
362812|NCT01085903|O1|Outcome|Normal Subjects: Baseline vs CPS|"Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
362813|NCT01085903|E2|Reported Event|Stroke Subjects|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive modafinil, placebo, baseline, CPS, Post CPS and Follow up interventions.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition.~Follow up: Follow up testing occurred at 3 months"
362814|NCT01085903|E1|Reported Event|Normal Subjects|"Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition.~Follow up: Follow up testing occurred at 3 months"
362815|NCT01085825|B3|Baseline|Total|Total of all reporting groups
362816|NCT01085825|B2|Baseline|Electric Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
363146|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
362817|NCT01085825|B1|Baseline|Manual Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
362818|NCT01085825|P2|Participant Flow|Electric Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
362819|NCT01085825|P1|Participant Flow|Manual Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
362820|NCT01085825|O2|Outcome|Electric Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
362821|NCT01085825|O1|Outcome|Manual Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
362822|NCT01085825|E2|Reported Event|Electric Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
362823|NCT01085825|E1|Reported Event|Manual Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
362824|NCT01085786|B3|Baseline|Total|Total of all reporting groups
362825|NCT01085786|B2|Baseline|14-day Hybrid Treatment|esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
362826|NCT01085786|B1|Baseline|14-day Sequential Treatment|One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
362827|NCT01085786|P2|Participant Flow|14-day Hybrid Treatment|esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
362828|NCT01085786|P1|Participant Flow|14-day Sequential Treatment|One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
362829|NCT01085786|O2|Outcome|14-day Hybrid Treatment|esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
362830|NCT01085786|O1|Outcome|14-day Sequential Treatment|One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
362831|NCT01085786|E2|Reported Event|14-day Hybrid Treatment|esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
362832|NCT01085786|E1|Reported Event|14-day Sequential Treatment|One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
362833|NCT01085760|B5|Baseline|Total|Total of all reporting groups
362834|NCT01085760|B4|Baseline|High Dose Metronidazole|metronidazole 500 mg 3 times a day
362835|NCT01085760|B3|Baseline|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
362836|NCT01085760|B2|Baseline|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
362837|NCT01085760|B1|Baseline|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
362838|NCT01085760|P4|Participant Flow|High Dose Metronidazole|metronidazole 500 mg 3 times a day
362839|NCT01085760|P3|Participant Flow|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
362840|NCT01085760|P2|Participant Flow|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
362841|NCT01085760|P1|Participant Flow|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
362842|NCT01085760|O4|Outcome|High Dose Metronidazole|Metronidazole 500 mg 3 times a day
362843|NCT01085760|O3|Outcome|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
362844|NCT01085760|O2|Outcome|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
362845|NCT01085760|O1|Outcome|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
362846|NCT01085760|O4|Outcome|High Dose Metronidazole|Metronidazole 500 mg 3 times a day
362847|NCT01085760|O3|Outcome|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
362848|NCT01085760|O2|Outcome|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
362849|NCT01085760|O1|Outcome|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
362850|NCT01085760|O4|Outcome|High Dose Metronidazole|Metronidazole 500 mg 3 times a day
362851|NCT01085760|O3|Outcome|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
362852|NCT01085760|O2|Outcome|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
362853|NCT01085760|O1|Outcome|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
362854|NCT01085760|O4|Outcome|High Dose Metronidazole|Metronidazole 500 mg 3 times a day
362855|NCT01085760|O3|Outcome|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
362856|NCT01085760|O2|Outcome|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
362857|NCT01085760|O1|Outcome|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
362858|NCT01085760|E4|Reported Event|High Dose Metronidazole|metronidazole 500 mg 3 times a day
362859|NCT01085760|E3|Reported Event|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
362860|NCT01085760|E2|Reported Event|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
362861|NCT01085760|E1|Reported Event|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
362862|NCT01085734|B3|Baseline|Total|Total of all reporting groups
362863|NCT01085734|B2|Baseline|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 microns.
362864|NCT01085734|B1|Baseline|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 micros
362865|NCT01085734|P2|Participant Flow|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
362866|NCT01085734|P1|Participant Flow|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 micros
362867|NCT01085734|O2|Outcome|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
362868|NCT01085734|O1|Outcome|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns
362869|NCT01085734|O2|Outcome|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
362870|NCT01085734|O1|Outcome|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns
362871|NCT01085734|O2|Outcome|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
362872|NCT01085734|O1|Outcome|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
362873|NCT01085734|E2|Reported Event|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 microns.
362874|NCT01085734|E1|Reported Event|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 micros
362875|NCT01085682|B3|Baseline|Total|Total of all reporting groups
362876|NCT01085682|B2|Baseline|Standard Care|Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
362877|NCT01085682|B1|Baseline|Lifestyle Counseling|Lifestyle counseling: In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study.
362878|NCT01085682|P2|Participant Flow|Standard Care|Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
362879|NCT01085682|P1|Participant Flow|Lifestyle Counseling|Lifestyle counseling: In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study.
362880|NCT01085682|O2|Outcome|Standard Care|Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
362881|NCT01085682|O1|Outcome|Lifestyle Counseling|Lifestyle counseling: In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study.
362882|NCT01085682|E2|Reported Event|Standard Care|Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
362883|NCT01085682|E1|Reported Event|Lifestyle Counseling|Lifestyle counseling: In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study.
362884|NCT01085643|B1|Baseline|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
362885|NCT01085643|P1|Participant Flow|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
362886|NCT01085643|O1|Outcome|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
362887|NCT01085643|O1|Outcome|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
363147|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
363148|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
362888|NCT01085643|O1|Outcome|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
362889|NCT01085643|O1|Outcome|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
362890|NCT01085643|O1|Outcome|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
362891|NCT01085643|O1|Outcome|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
362892|NCT01085643|E1|Reported Event|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
362893|NCT01085591|B4|Baseline|Total|Total of all reporting groups
362894|NCT01085591|B3|Baseline|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
362895|NCT01085591|B2|Baseline|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days.
362896|NCT01085591|B1|Baseline|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
362897|NCT01085591|P3|Participant Flow|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
362898|NCT01085591|P2|Participant Flow|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days.
362899|NCT01085591|P1|Participant Flow|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
362900|NCT01085591|O3|Outcome|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
362901|NCT01085591|O2|Outcome|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
362902|NCT01085591|O1|Outcome|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
362903|NCT01085591|O3|Outcome|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
362904|NCT01085591|O2|Outcome|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
362905|NCT01085591|O1|Outcome|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
362906|NCT01085591|O3|Outcome|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
362907|NCT01085591|O2|Outcome|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
362908|NCT01085591|O1|Outcome|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
362909|NCT01085591|O3|Outcome|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
362910|NCT01085591|O2|Outcome|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
362911|NCT01085591|O1|Outcome|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
362912|NCT01085591|O3|Outcome|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
362913|NCT01085591|O2|Outcome|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
362914|NCT01085591|O1|Outcome|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
362915|NCT01085591|O3|Outcome|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
362916|NCT01085591|O2|Outcome|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
362917|NCT01085591|O1|Outcome|CB-183,315, 125mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
362918|NCT01085591|E3|Reported Event|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
362919|NCT01085591|E2|Reported Event|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days.
362920|NCT01085591|E1|Reported Event|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
362921|NCT01085539|B1|Baseline|Infants With Oxygen Level Monitoring|In infants monitored for oxygen levels, the number of alarms that resulted in clinicians responding with an intervention that changed their care.
362922|NCT01085539|P1|Participant Flow|Infants With Oxygen Level Monitoring|In infants monitored for oxygen levels, the number of alarms that resulted in clinicians responding with an intervention that changed their care.
362923|NCT01085539|O1|Outcome|Infants With Oxygen Level Monitoring|In infants monitored for oxygen levels, the number of alarms that resulted in clinicians responding with an intervention that changed their care.
362924|NCT01085539|E1|Reported Event|Infants With Oxygen Level Monitoring|In infants monitored for oxygen levels, the number of alarms that resulted in clinicians responding with an intervention that changed their care.
362925|NCT01085513|B3|Baseline|Total|Total of all reporting groups
362926|NCT01085513|B2|Baseline|Healthy Volunteers|"Healthy volunteers~PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body."
362927|NCT01085513|B1|Baseline|Patients|"Patients previously indicated for manometry~PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body."
362928|NCT01085513|P2|Participant Flow|Healthy Volunteers|Healthy volunteers
362929|NCT01085513|P1|Participant Flow|Patients|Patients previously indicated for manometry
362930|NCT01085513|O2|Outcome|Patients|"Patients previously indicated for manometry~PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body."
362931|NCT01085513|O1|Outcome|Healthy Volunteers|"Healthy volunteers~PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body."
362932|NCT01085513|E2|Reported Event|Healthy Volunteers|"Healthy volunteers~PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body."
362933|NCT01085513|E1|Reported Event|Patients|"Patients previously indicated for manometry~Two Moderate adverse events not related to studies procedure were reported within this study: abdominal pain and nausea.~In one case (i.e., abdominal pain) emergency visit occurred and the adverse events was resolved within four days."
362934|NCT01085500|B3|Baseline|Total|Total of all reporting groups
362935|NCT01085500|B2|Baseline|Current Practice|General surgery residents will undergo training according to current practice.
362936|NCT01085500|B1|Baseline|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
362937|NCT01085500|P2|Participant Flow|Current Practice|General surgery residents will undergo training according to current practice.
362938|NCT01085500|P1|Participant Flow|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
362939|NCT01085500|O2|Outcome|Current Practice|General surgery residents will undergo training according to current practice.
362940|NCT01085500|O1|Outcome|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
362941|NCT01085500|O2|Outcome|Current Practice|General surgery residents will undergo training according to current practice.
362942|NCT01085500|O1|Outcome|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
362943|NCT01085500|O2|Outcome|Current Practice|General surgery residents will undergo training according to current practice.
362944|NCT01085500|O1|Outcome|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
362945|NCT01085500|E2|Reported Event|Current Practice|General surgery residents will undergo training according to current practice.
362946|NCT01085500|E1|Reported Event|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
362947|NCT01085357|B3|Baseline|Total|Total of all reporting groups
362948|NCT01085357|B2|Baseline|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
362949|NCT01085357|B1|Baseline|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
362950|NCT01085357|P2|Participant Flow|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
362951|NCT01085357|P1|Participant Flow|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
362952|NCT01085357|O2|Outcome|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
362953|NCT01085357|O1|Outcome|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
362954|NCT01085357|O2|Outcome|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
362955|NCT01085357|O1|Outcome|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
362956|NCT01085357|O2|Outcome|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
362957|NCT01085357|O1|Outcome|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
362958|NCT01085357|E2|Reported Event|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
362959|NCT01085357|E1|Reported Event|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
362960|NCT01085331|B3|Baseline|Total|Total of all reporting groups
363033|NCT01085201|O3|Outcome|Stage 2B|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
362961|NCT01085331|B2|Baseline|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362962|NCT01085331|B1|Baseline|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362963|NCT01085331|P2|Participant Flow|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 milligram per square meter [mg/m^2] intravenous [i.v] infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; Irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 milliliter [mL] dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362964|NCT01085331|P1|Participant Flow|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 milligrams per day (mg/day) once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 milligram per square meter [mg/m^2] intravenous [i.v] infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 milliliter [mL] dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2.) at conventional doses on days 1 and 15 of the same 28 day cycle.
362965|NCT01085331|O2|Outcome|Part 2 or Phase 2 Randomized Part: Placebo+FOLFIRI|Placebo was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362966|NCT01085331|O1|Outcome|Part 2 or Phase 2 Randomized Part: Pimasertib+FOLFIRI|Pimasertib was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362967|NCT01085331|O2|Outcome|Part 2 or Phase 2 Randomized Part: Placebo+FOLFIRI|Placebo was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362968|NCT01085331|O1|Outcome|Part 2 or Phase 2 Randomized Part: Pimasertib+FOLFIRI|Pimasertib was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362969|NCT01085331|O2|Outcome|Part 2 or Phase 2 Randomized Part: Placebo+FOLFIRI|Placebo was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362970|NCT01085331|O1|Outcome|Part 2 or Phase 2 Randomized Part: Pimasertib+FOLFIRI|Pimasertib was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362971|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362972|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
363034|NCT01085201|O2|Outcome|Stage 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
363035|NCT01085201|O1|Outcome|Stage 1|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
363149|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
362973|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362974|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362975|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362976|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362977|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362978|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362979|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362980|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362981|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362982|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362983|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362984|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
363036|NCT01085201|O5|Outcome|Stage 4 - Dose Level 2|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
363037|NCT01085201|O4|Outcome|Stage 3 - Dose Level 2|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
362985|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362986|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362987|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362988|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362989|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362990|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362991|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362992|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362993|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362994|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362995|NCT01085331|O2|Outcome|Part 2 or Phase 2 Randomized Part: Placebo +FOLFIRI|Placebo was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a Bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362996|NCT01085331|O1|Outcome|Part 2 or Phase 2 Randomized Part: Pimasertib+FOLFIRI|Pimasertib was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
363038|NCT01085201|O3|Outcome|Stage 2B - Dose Level 2|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
363039|NCT01085201|O2|Outcome|Stage 2 - Dose Level 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
362997|NCT01085331|O1|Outcome|Pimasertib+FOLFIRI (Overall)|Pimasertib was administered orally once daily 45 mg/day and 60 mg/day on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a Bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362998|NCT01085331|E2|Reported Event|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
362999|NCT01085331|E1|Reported Event|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
363000|NCT01085318|B3|Baseline|Total|Total of all reporting groups
363001|NCT01085318|B2|Baseline|Arm 2 Healthy Control|Healthy Control
363002|NCT01085318|B1|Baseline|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
363003|NCT01085318|P2|Participant Flow|Arm 2 Healthy Control|Healthy Control
363004|NCT01085318|P1|Participant Flow|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
363005|NCT01085318|O1|Outcome|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
363006|NCT01085318|O1|Outcome|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
363007|NCT01085318|O2|Outcome|Arm 2 Healthy Control|Healthy Control
363008|NCT01085318|O1|Outcome|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
363009|NCT01085318|O2|Outcome|Arm 2 Healthy Control|Healthy Control
363010|NCT01085318|O1|Outcome|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
363011|NCT01085318|E2|Reported Event|Arm 2 Healthy Control|Healthy Control
363012|NCT01085318|E1|Reported Event|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
363013|NCT01085214|B1|Baseline|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
363014|NCT01085214|P1|Participant Flow|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
363015|NCT01085214|O1|Outcome|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
363016|NCT01085214|O1|Outcome|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
363017|NCT01085214|O1|Outcome|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
363018|NCT01085214|O1|Outcome|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
363019|NCT01085214|E1|Reported Event|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
363020|NCT01085201|B6|Baseline|Total|Total of all reporting groups
363021|NCT01085201|B5|Baseline|Stage 4|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
363022|NCT01085201|B4|Baseline|Stage 3|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
363023|NCT01085201|B3|Baseline|Stage 2B|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
363024|NCT01085201|B2|Baseline|Stage 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
363025|NCT01085201|B1|Baseline|Stage 1|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
363026|NCT01085201|P5|Participant Flow|Stage 4|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
363027|NCT01085201|P4|Participant Flow|Stage 3|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
363028|NCT01085201|P3|Participant Flow|Stage 2B|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
363029|NCT01085201|P2|Participant Flow|Stage 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
363030|NCT01085201|P1|Participant Flow|Stage 1|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
363031|NCT01085201|O5|Outcome|Stage 4|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
363127|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
363040|NCT01085201|O1|Outcome|Stage 1 - Dose Levels 0, 1 and 2|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
363041|NCT01085201|O5|Outcome|Stage 4 - Dose Level 2|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
363042|NCT01085201|O4|Outcome|Stage 3 - Dose Level 2|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
363043|NCT01085201|O3|Outcome|Stage 2B - Dose Level 2|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
363044|NCT01085201|O2|Outcome|Stage 2 - Dose Level 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
363045|NCT01085201|O1|Outcome|Stage 1 - Dose Levels 0, 1 and 2|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
363046|NCT01085201|E5|Reported Event|Stage 4 - Dose Level 2|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
363047|NCT01085201|E4|Reported Event|Stage 3 - Dose Level 2|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
363048|NCT01085201|E3|Reported Event|Stage 2B - Dose Level 2|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
363049|NCT01085201|E2|Reported Event|Stage 2 - Dose Level 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
363050|NCT01085201|E1|Reported Event|Stage 1 - Dose Levels 0, 1 and 2|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
363051|NCT01085136|B1|Baseline|Afatinib Monotherapy (Part A)|Afatinib 50 mg film-coated tablet was orally administered once daily of each 28-day treatment course, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme).
363052|NCT01085136|P3|Participant Flow|Investigators Choice of Chemotherapy (Part B)|Reference therapy for Part B dose: Depending on schedule Intravenous or oral administration (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
363053|NCT01085136|P2|Participant Flow|Afatinib Plus Paclitaxel (Part B)|Afatinib 40 mg film-coated tablet dose was orally administered once daily of each 28-day treatment course, with dose reductions to 30 mg/day and 20 mg/day (following the protocol defined dose reduction scheme) plus paclitaxel 80 mg/m2 administered via intravenous infusion once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
363054|NCT01085136|P1|Participant Flow|Afatinib Monotherapy (Part A)|Afatinib 50 mg film-coated tablet was orally administered once daily of each 28-day treatment course, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme).
363055|NCT01085136|O3|Outcome|Investigators Choice of Chemotherapy (Part B)|Reference therapy for Part B dose: Depending on schedule Intravenous or oral administration (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
363056|NCT01085136|O2|Outcome|Afatinib Plus Paclitaxel (Part B)|Afatinib 40 mg film-coated tablet dose was orally administered once daily of each 28-day treatment course, with dose reductions to 30 mg/day and 20 mg/day (following the protocol defined dose reduction scheme) plus paclitaxel 80 mg/m2 administered via intravenous infusion once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
363057|NCT01085136|O1|Outcome|Afatinib Monotherapy (Part A)|Afatinib 50 mg film-coated tablet was orally administered once daily of each 28-day treatment course, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme).
363058|NCT01085136|O2|Outcome|Investigators Choice of Chemotherapy (Part B)|Reference therapy for Part B dose: Depending on schedule Intravenous or oral administration (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
363059|NCT01085136|O1|Outcome|Afatinib Plus Paclitaxel (Part B)|Afatinib 40 mg film-coated tablet dose was orally administered once daily of each 28-day treatment course, with dose reductions to 30 mg/day and 20 mg/day (following the protocol defined dose reduction scheme) plus paclitaxel 80 mg/m2 administered via intravenous infusion once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
363060|NCT01085136|O1|Outcome|Afatinib Monotherapy (Part A)|Afatinib 50 mg film-coated tablet was orally administered once daily of each 28-day treatment course, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme).
363061|NCT01085136|O2|Outcome|Investigators Choice of Chemotherapy (Part B)|Reference therapy for Part B dose: Depending on schedule Intravenous or oral administration (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
363062|NCT01085136|O1|Outcome|Afatinib Plus Paclitaxel (Part B)|Afatinib 40 mg film-coated tablet dose was orally administered once daily of each 28-day treatment course, with dose reductions to 30 mg/day and 20 mg/day (following the protocol defined dose reduction scheme) plus paclitaxel 80 mg/m2 administered via intravenous infusion once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
363063|NCT01085136|O1|Outcome|Afatinib Monotherapy (Part A)|Afatinib 50 mg film-coated tablet was orally administered once daily of each 28-day treatment course, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme).
363128|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
363064|NCT01085136|O2|Outcome|Investigators Choice of Chemotherapy (Part B)|Reference therapy for Part B dose: Depending on schedule Intravenous or oral administration (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
363065|NCT01085136|O1|Outcome|Afatinib Plus Paclitaxel (Part B)|Afatinib 40 mg film-coated tablet dose was orally administered once daily of each 28-day treatment course, with dose reductions to 30 mg/day and 20 mg/day (following the protocol defined dose reduction scheme) plus paclitaxel 80 mg/m2 administered via intravenous infusion once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
363066|NCT01085136|E3|Reported Event|Investigators Choice of Chemotherapy (Part B)|Reference therapy for Part B dose: Depending on schedule Intravenous or oral administration (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
363067|NCT01085136|E2|Reported Event|Afatinib Plus Paclitaxel (Part B)|Afatinib 40 mg film-coated tablet dose was orally administered once daily of each 28-day treatment course, with dose reductions to 30 mg/day and 20 mg/day (following the protocol defined dose reduction scheme) plus paclitaxel 80 mg/m2 administered via intravenous infusion once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
363068|NCT01085136|E1|Reported Event|Afatinib Monotherapy (Part A)|Afatinib 50 mg film-coated tablet was orally administered once daily of each 28-day treatment course, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme).
363069|NCT01085045|B1|Baseline|All Subjects|All Baseline Subjects
363070|NCT01085045|P1|Participant Flow|Overall Study|Sentinel patients were the first 4 patients enrolled to receive one week of treatment with either GFF MDI 72/9.6mcg, GFF MDI 36/9.6 mcg, GP MDI 36 mcg or FF MDI 9.6 mcg because this was the first time GFF MDI was administered to patients with COPD, the sentinel patients provided additional assurance of safety.9.6
363071|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
363072|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
363073|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
363074|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
363075|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
363076|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
363077|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
363078|NCT01085045|O6|Outcome|Foradil 12 μg|Foradil 12 μg
363079|NCT01085045|O5|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
363080|NCT01085045|O4|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
363081|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
363082|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
363083|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
363084|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
363085|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
363086|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
363087|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
363088|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
363089|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
363090|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
363091|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
363092|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
363093|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
363094|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
363095|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
363096|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
363097|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
363098|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
363099|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
363100|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
363101|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
363102|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
363103|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
363104|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
363105|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
363106|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
363107|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
363108|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
363109|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
363110|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
363111|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
363112|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
363113|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
363114|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
363115|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
363116|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
363117|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
363118|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
363119|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
363120|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
363121|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
363122|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
363123|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
363124|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
363125|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
363126|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
363152|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
363153|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
363154|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
363155|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
363156|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
363157|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
363158|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
363159|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
363160|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
363161|NCT01085045|E8|Reported Event|Foradil Aerolizer|Foradil Aerolizer 12 μg
363162|NCT01085045|E7|Reported Event|Placebo|Placebo MDI
363163|NCT01085045|E6|Reported Event|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
363164|NCT01085045|E5|Reported Event|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
363165|NCT01085045|E4|Reported Event|Spiriva|Handihaler 18 μg
363166|NCT01085045|E3|Reported Event|GP MDI 36 μg|GP MDI 36 μg (PT001)
363167|NCT01085045|E2|Reported Event|GP/FF MDI 36/9.6 μg|GP/FF MDI 36/9.6 μg (PT003)
363168|NCT01085045|E1|Reported Event|GP/FF MDI 72/9.6 μg|GP/FF MDI 72/9.6 μg (PT003)
363169|NCT01085006|B3|Baseline|Total|Total of all reporting groups
363170|NCT01085006|B2|Baseline|Normal Saline Infusion|
363171|NCT01085006|B1|Baseline|Tranexamic Acid|
363172|NCT01085006|P2|Participant Flow|Normal Saline Infusion|
363173|NCT01085006|P1|Participant Flow|Tranexamic Acid|
363174|NCT01085006|O2|Outcome|Normal Saline Infusion|
363175|NCT01085006|O1|Outcome|Tranexamic Acid|
363176|NCT01085006|E2|Reported Event|Normal Saline Infusion|
363177|NCT01085006|E1|Reported Event|Tranexamic Acid|
363178|NCT01084759|B1|Baseline|Etoposide and Testosterone|Patients will receive an intramuscular gluteal injection with testosterone cypionate at a dose of 400 mg every month for a total of 3 injections (i.e. 3 months of therapy).On the day of testosterone injection (i.e. day 1 of each cycle) patients will begin therapy with oral etoposide at a dose of 100 mg/day given in divided doses (one 50 mg etoposide capsule q 12 h) for 14 consecutive days.
363179|NCT01084759|P1|Participant Flow|Testosterone|Men with castration-resistant prostate cancer will continue on androgen ablative therapy with LHRH agonist (i.e. Zoladex or Lupron) if not surgically castrated. Patients will receive intramuscular injection with testosterone cypionate at a dose of 400 mg every month for a total of 3 injections (i.e. 3 months of therapy).
363180|NCT01084759|O1|Outcome|Treatment Group|Testosterone cypionate 400 mg intramuscular, day 1 of 28; etoposide 100 mg oral daily, days 1-14 of 28. Note: Etoposide is only given for 3, 28-day cycles.
363181|NCT01084759|O1|Outcome|Treatment Group|Testosterone cypionate 400 mg intramuscular, day 1 of 28; etoposide 100 mg oral daily, days 1-14 of 28. Note: Etoposide is only given for 3, 28-day cycles.
363182|NCT01084759|O1|Outcome|Treatment Group|Testosterone cypionate 400 mg intramuscular, day 1 of 28; etoposide 100 mg oral daily, days 1-14 of 28. Note: Etoposide is only given for 3, 28-day cycles.
363183|NCT01084759|E1|Reported Event|Treatment Group|Men with castration-resistant prostate cancer will continue on androgen ablative therapy with LHRH agonist (i.e. Zoladex or Lupron) if not surgically castrated. Patients will receive intramuscular injection with testosterone cypionate at a dose of 400 mg every month for a total of 3 injections (i.e. 3 months of therapy).
363184|NCT01084707|B1|Baseline|All Randomized Subjects|All subjects randomized into the trial, e.g., Full Analysis Set
363185|NCT01084707|P1|Participant Flow|Overall Study|All subjects randomized into the trial
363186|NCT01084707|O5|Outcome|Nicorette® Gum 4 mg|12 doses of NICORETTE® gum 4 mg over 11 hours
363187|NCT01084707|O4|Outcome|NiQuitin™ Lozenge 4 mg|NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
363188|NCT01084707|O3|Outcome|Oral Nicotine 48|Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
363189|NCT01084707|O2|Outcome|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
363190|NCT01084707|O1|Outcome|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
363191|NCT01084707|O2|Outcome|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
363192|NCT01084707|O1|Outcome|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
363193|NCT01084707|O5|Outcome|Nicorette® Gum 4 mg|12 doses of NICORETTE® gum 4 mg over 11 hours
363194|NCT01084707|O4|Outcome|NiQuitin™ Lozenge 4 mg|NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
363195|NCT01084707|O3|Outcome|Oral Nicotine 48|Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
363196|NCT01084707|O2|Outcome|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
363197|NCT01084707|O1|Outcome|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
363198|NCT01084707|O5|Outcome|Nicorette® Gum 4 mg|12 doses of NICORETTE® gum 4 mg over 11 hours
363199|NCT01084707|O4|Outcome|NiQuitin™ Lozenge 4 mg|NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
363200|NCT01084707|O3|Outcome|Oral Nicotine 48|Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
363201|NCT01084707|O2|Outcome|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
363202|NCT01084707|O1|Outcome|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
363203|NCT01084707|O5|Outcome|Nicorette® Gum 4 mg|12 doses of NICORETTE® gum 4 mg over 11 hours
363204|NCT01084707|O4|Outcome|NiQuitin™ Lozenge 4 mg|NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
363205|NCT01084707|O3|Outcome|Oral Nicotine 48|Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
363206|NCT01084707|O2|Outcome|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
363207|NCT01084707|O1|Outcome|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
363208|NCT01084707|O5|Outcome|Nicorette® Gum 4 mg|12 doses of NICORETTE® gum 4 mg over 11 hours
363209|NCT01084707|O4|Outcome|NiQuitin™ Lozenge 4 mg|NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
363210|NCT01084707|O3|Outcome|Oral Nicotine 48|Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
363211|NCT01084707|O2|Outcome|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
363212|NCT01084707|O1|Outcome|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
363213|NCT01084707|E5|Reported Event|Nicorette® Gum 4 mg|12 doses of NICORETTE® gum 4 mg over 11 hours
363214|NCT01084707|E4|Reported Event|NiQuitin™ Lozenge 4 mg|NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
363215|NCT01084707|E3|Reported Event|Oral Nicotine 48|Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
363216|NCT01084707|E2|Reported Event|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
363217|NCT01084707|E1|Reported Event|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
363218|NCT01084668|B1|Baseline|Adalimumab|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
363219|NCT01084668|P1|Participant Flow|Adalimumab|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
363220|NCT01084668|O1|Outcome|All Treated|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatoid drug (BDMARD) failure
363221|NCT01084668|O2|Outcome|Subgroup With Nail Psoriasis|Subgroup of participants with nail psoriasis and a NAPSI score greater than 0 for at least 1 study visit
363222|NCT01084668|O1|Outcome|All Treated|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatoid drug (BDMARD) failure
363223|NCT01084668|O1|Outcome|All Treated|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatoid drug (BDMARD) failure
363224|NCT01084668|O1|Outcome|All Treated|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
363225|NCT01084668|O1|Outcome|All Treated|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
363226|NCT01084668|E1|Reported Event|Adalimumab|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
363227|NCT01084603|B1|Baseline|Overall Study|Full Safety Set
363228|NCT01084603|P1|Participant Flow|Overall Study|Full Safety Set
363229|NCT01084603|O5|Outcome|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
363230|NCT01084603|O4|Outcome|NiQuitinTM Lozenge 4 mg|1 NiQuitinTM nicotine lozenge 4 mg
363231|NCT01084603|O3|Outcome|Oral Nicotine 4|4 administrations of 1 mg
363232|NCT01084603|O2|Outcome|Oral Nicotine 2|2 administrations of 1 mg
363233|NCT01084603|O1|Outcome|Oral Nicotine 1|1 administration of 1 mg
363234|NCT01084603|O1|Outcome|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
363235|NCT01084603|O5|Outcome|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
363236|NCT01084603|O4|Outcome|NiQuitinTM Lozenge 4 mg|1 NiQuitinTM nicotine lozenge 4 mg
363237|NCT01084603|O3|Outcome|Oral Nicotine 4|4 administrations of 1 mg
363238|NCT01084603|O2|Outcome|Oral Nicotine 2|2 administrations of 1 mg
363239|NCT01084603|O1|Outcome|Oral Nicotine 1|1 administration of 1 mg
363240|NCT01084603|O5|Outcome|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
363241|NCT01084603|O4|Outcome|NiQuitinTM Lozenge 4 mg|1 NiQuitinTM nicotine lozenge 4 mg
363242|NCT01084603|O3|Outcome|Oral Nicotine 4|4 administrations of 1 mg
363243|NCT01084603|O2|Outcome|Oral Nicotine 2|2 administrations of 1 mg
363244|NCT01084603|O1|Outcome|Oral Nicotine 1|1 administration of 1 mg
363245|NCT01084603|O5|Outcome|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
363246|NCT01084603|O4|Outcome|NiQuitinTM Lozenge 4 mg|1 NiQuitinTM nicotine lozenge 4 mg
363247|NCT01084603|O3|Outcome|Oral Nicotine 4|4 administrations of 1 mg
363248|NCT01084603|O2|Outcome|Oral Nicotine 2|2 administrations of 1 mg
363249|NCT01084603|O1|Outcome|Oral Nicotine 1|1 administration of 1 mg
363250|NCT01084603|O5|Outcome|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
363251|NCT01084603|O4|Outcome|NiQuitinTM Lozenge 4 mg|1 NiQuitinTM nicotine lozenge 4 mg
363252|NCT01084603|O3|Outcome|Oral Nicotine 4|4 administrations of 1 mg
363253|NCT01084603|O2|Outcome|Oral Nicotine 2|2 administrations of 1 mg
363254|NCT01084603|O1|Outcome|Oral Nicotine 1|1 administration of 1 mg
363255|NCT01084603|E5|Reported Event|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
363256|NCT01084603|E4|Reported Event|NiQuitinTM Lozenge 4 mg|1 NiQuitinTM nicotine lozenge 4 mg
363257|NCT01084603|E3|Reported Event|Oral Nicotine 4|4 administrations of 1 mg
363258|NCT01084603|E2|Reported Event|Oral Nicotine 2|2 administrations of 1 mg
363259|NCT01084603|E1|Reported Event|Oral Nicotine 1|1 administration of 1 mg
363260|NCT01084551|B4|Baseline|Total|Total of all reporting groups
363261|NCT01084551|B3|Baseline|SPM 962 6.75|started at 2.25 mg/day to 6.75 mg/day for 13 weeks
363262|NCT01084551|B2|Baseline|SPM 962 4.5|started at 2.25 mg/day to 4.5 mg/day for 13 weeks
363263|NCT01084551|B1|Baseline|Placebo|0 mg/day for 13 weeks
363264|NCT01084551|P3|Participant Flow|SPM 962 6.75|started at 2.25 mg/day to 6.75 mg/day for 13 weeks
363265|NCT01084551|P2|Participant Flow|SPM 962 4.5|started at 2.25 mg/day to 4.5 mg/day for 13 weeks
363266|NCT01084551|P1|Participant Flow|Placebo|0 mg/day for 13 weeks
363267|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
363268|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
363269|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
363270|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
363271|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
363272|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
363273|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
363274|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
363275|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
363276|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
363277|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
363278|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
363279|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
363280|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
363281|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
363282|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
363283|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
363284|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
363285|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
363286|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
363287|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
363288|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
363289|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
363290|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
363291|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
363292|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
363293|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
363294|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
363295|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
363296|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
363297|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
363298|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
363299|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
363300|NCT01084551|E3|Reported Event|SPM 962 6.75|started at 2.25 mg/day to 6.75 mg/day for 13 weeks
363301|NCT01084551|E2|Reported Event|SPM 962 4.5|started at 2.25 mg/day to 4.5 mg/day for 13 weeks
363302|NCT01084551|E1|Reported Event|Placebo|0 mg/day for 13 weeks
363303|NCT01084538|B1|Baseline|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
363304|NCT01084538|P1|Participant Flow|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
363305|NCT01084538|O1|Outcome|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
363306|NCT01084538|O1|Outcome|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
363343|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
363307|NCT01084538|O1|Outcome|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
363308|NCT01084538|O1|Outcome|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
363309|NCT01084538|E1|Reported Event|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
363310|NCT01084278|B6|Baseline|Total|Total of all reporting groups
363311|NCT01084278|B5|Baseline|ESRD|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
363312|NCT01084278|B4|Baseline|Severe|Participants with severe renal impairment (eGFR 15 to 29 mL/min) received one colchicine 0.6 mg tablet on study day 1.
363313|NCT01084278|B3|Baseline|Moderate|Participants with moderate renal impairment CrCl/eGFR 30 to 59 mL/min) received one colchicine 0.6 mg tablet on study day 1.
363314|NCT01084278|B2|Baseline|Mild|Participants with mild renal impairment (estimated Glomerular Filtration Rate [eGFR] 60 to 89 mL/min) received one colchicine 0.6 mg tablet on study day 1.
363315|NCT01084278|B1|Baseline|Healthy|Healthy participants with normal renal function (Creatinine Clearance [CrCl] ≥90 mL/min) received one colchicine 0.6 mg tablet on study day 1.
363316|NCT01084278|P5|Participant Flow|ESRD|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
363317|NCT01084278|P4|Participant Flow|Severe|Participants with severe renal impairment (eGFR 15 to 29 mL/min) received one colchicine 0.6 mg tablet on study day 1.
363318|NCT01084278|P3|Participant Flow|Moderate|Participants with moderate renal impairment CrCl/eGFR 30 to 59 mL/min) received one colchicine 0.6 mg tablet on study day 1.
363319|NCT01084278|P2|Participant Flow|Mild|Participants with mild renal impairment (estimated Glomerular Filtration Rate [eGFR] 60 to 89 mL/min) received one colchicine 0.6 mg tablet on study day 1.
363320|NCT01084278|P1|Participant Flow|Healthy|Healthy participants with normal renal function (Creatinine Clearance [CrCl] ≥90 mL/min) received one colchicine 0.6 mg tablet on study day 1.
363321|NCT01084278|O1|Outcome|End Stage Renal Disease (ESRD)|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken under standard fasting conditions on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
363322|NCT01084278|O1|Outcome|End Stage Renal Disease (ESRD)|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken under standard fasting conditions on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
363323|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
363324|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
363325|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
363326|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
363327|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
363328|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
363329|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
363330|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
363331|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
363332|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
363333|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
363334|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
363335|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
363336|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
363337|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
363338|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
363339|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
363340|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
363341|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
363342|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
363344|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
363345|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
363346|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
363347|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
363348|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
363349|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
363350|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
363351|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
363352|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
363353|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
363354|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
363355|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
363356|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
363357|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
363358|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
363359|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
363360|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
363361|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
363362|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
363363|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
363364|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
363365|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
363366|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
363367|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
363368|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
363369|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
363370|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
363371|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
363372|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
363373|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
363374|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
363375|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
363376|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
363377|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
363378|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
363379|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
363380|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
363381|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
363382|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
363383|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
363384|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
363385|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
363386|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
363387|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
363388|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
363431|NCT01084174|B3|Baseline|Total|Total of all reporting groups
363389|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
363390|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
363391|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
363392|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
363393|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
363394|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
363395|NCT01084278|E5|Reported Event|ESRD|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
363396|NCT01084278|E4|Reported Event|Severe|Participants with severe renal impairment (eGFR 15 to 29 mL/min) received one colchicine 0.6 mg tablet on study day 1.
363397|NCT01084278|E3|Reported Event|Moderate|Participants with moderate renal impairment CrCl/eGFR 30 to 59 mL/min) received one colchicine 0.6 mg tablet on study day 1.
363398|NCT01084278|E2|Reported Event|Mild|Participants with mild renal impairment (estimated Glomerular Filtration Rate [eGFR] 60 to 89 mL/min) received one colchicine 0.6 mg tablet on study day 1.
363399|NCT01084278|E1|Reported Event|Healthy|Healthy participants with normal renal function (Creatinine Clearance [CrCl] ≥90 mL/min) received one colchicine 0.6 mg tablet on study day 1.
363400|NCT01084265|B1|Baseline|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
363401|NCT01084265|P1|Participant Flow|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
363402|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
363403|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
363404|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
363405|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
363406|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
363407|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
363408|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
363409|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
363410|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
363411|NCT01084265|E1|Reported Event|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
363412|NCT01084239|B3|Baseline|Total|Total of all reporting groups
363413|NCT01084239|B2|Baseline|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
363414|NCT01084239|B1|Baseline|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
363415|NCT01084239|P2|Participant Flow|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
363416|NCT01084239|P1|Participant Flow|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
363417|NCT01084239|O2|Outcome|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
363418|NCT01084239|O1|Outcome|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
363419|NCT01084239|O2|Outcome|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
363420|NCT01084239|O1|Outcome|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
363421|NCT01084239|O2|Outcome|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
363422|NCT01084239|O1|Outcome|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
363423|NCT01084239|O2|Outcome|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
363424|NCT01084239|O1|Outcome|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
363425|NCT01084239|O2|Outcome|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
363426|NCT01084239|O1|Outcome|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
363427|NCT01084239|O2|Outcome|Standard of Care|Subjects in this arm (50% of the total cohort) will continue to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
363428|NCT01084239|O1|Outcome|Cardiac CT|"Subjects in this arm (50% of the total cohort) will be randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT will be performed in addition to standard evaluation. Reconstructed data sets will be evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
363429|NCT01084239|E2|Reported Event|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
363430|NCT01084239|E1|Reported Event|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
363432|NCT01084174|B2|Baseline|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.~Peanut extract: Delivered sublingually~Placebo powder: Delivered orally"
363433|NCT01084174|B1|Baseline|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.~Peanut powder: Delivered orally~Placebo extract: Delivered sublingually"
363434|NCT01084174|P2|Participant Flow|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.~Peanut extract: Delivered sublingually~Placebo powder: Delivered orally"
363435|NCT01084174|P1|Participant Flow|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.~Peanut powder: Delivered orally~Placebo extract: Delivered sublingually"
363436|NCT01084174|O2|Outcome|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.~Peanut extract: Delivered sublingually~Placebo powder: Delivered orally"
363437|NCT01084174|O1|Outcome|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.~Peanut powder: Delivered orally~Placebo extract: Delivered sublingually"
363438|NCT01084174|O2|Outcome|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.~Peanut extract: Delivered sublingually~Placebo powder: Delivered orally"
363439|NCT01084174|O1|Outcome|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.~Peanut powder: Delivered orally~Placebo extract: Delivered sublingually"
363440|NCT01084174|O2|Outcome|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.~Peanut extract: Delivered sublingually~Placebo powder: Delivered orally"
363441|NCT01084174|O1|Outcome|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.~Peanut powder: Delivered orally~Placebo extract: Delivered sublingually"
363442|NCT01084174|O2|Outcome|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.~Peanut extract: Delivered sublingually~Placebo powder: Delivered orally"
363443|NCT01084174|O1|Outcome|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.~Peanut powder: Delivered orally~Placebo extract: Delivered sublingually"
363444|NCT01084174|O2|Outcome|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.~Peanut extract: Delivered sublingually~Placebo powder: Delivered orally"
363445|NCT01084174|O1|Outcome|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.~Peanut powder: Delivered orally~Placebo extract: Delivered sublingually"
363446|NCT01084174|O2|Outcome|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.~Peanut extract: Delivered sublingually~Placebo powder: Delivered orally"
363447|NCT01084174|O1|Outcome|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.~Peanut powder: Delivered orally~Placebo extract: Delivered sublingually"
363448|NCT01084174|O2|Outcome|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.~Peanut extract: Delivered sublingually~Placebo powder: Delivered orally"
363449|NCT01084174|O1|Outcome|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.~Peanut powder: Delivered orally~Placebo extract: Delivered sublingually"
363450|NCT01084174|E2|Reported Event|Active OIT/Placebo SLIT|Adverse event information is based on percentages of doses. There were 4049 total doses in the Active OIT/Placebo SLIT treatment arm
363451|NCT01084174|E1|Reported Event|Active SLIT/Placebo OIT|Adverse event information is based on percentages of doses. There were 4578 total doses in the Active SLIT/Placebo OIT treatment arm
363452|NCT01084148|B3|Baseline|Total|Total of all reporting groups
363453|NCT01084148|B2|Baseline|V0034 CR 01B Vehicle|"cream~V0034CR01B vehicle"
363454|NCT01084148|B1|Baseline|V0034CR01B|"cream~V0034CR01B"
363455|NCT01084148|P2|Participant Flow|V0034 CR 01B Vehicle|"cream~V0034CR01B vehicle"
363456|NCT01084148|P1|Participant Flow|V0034CR01B|"cream~V0034CR01B"
363457|NCT01084148|O2|Outcome|V0034 CR 01B Vehicle|"cream~V0034CR01B vehicle for 28 days (Period I), then treatment free-follow-up (up for 21 days if non persisting lesion and non relapsing lesions (Period II)), then V0034CR01B for 84 days (Period III)"
363458|NCT01084148|O1|Outcome|V0034CR01B|"cream~V0034CR01B for 28 days (Period I), then treatment free-follow-up (up for 21 days if non persisting lesion and non relapsing lesions (Period II)), then V0034CR01B for 84 days (Period III)"
363459|NCT01084148|O2|Outcome|V0034 CR 01B Vehicle|"cream~V0034CR01B vehicle"
363460|NCT01084148|O1|Outcome|V0034CR01B|"cream~V0034CR01B"
363461|NCT01084148|E2|Reported Event|V0034 CR 01B Vehicle|"cream~V0034CR01B vehicle"
363462|NCT01084148|E1|Reported Event|V0034CR01B|"cream~V0034CR01B"
363463|NCT01084135|B5|Baseline|Total|Total of all reporting groups
363464|NCT01084135|B4|Baseline|12 Week Liquid Placebo|"Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.~Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste."
363465|NCT01084135|B3|Baseline|12 Week Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional four weeks. At the week 6 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 6 weeks.
363466|NCT01084135|B2|Baseline|20 Week Liquid Placebo|"Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.~Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste."
363482|NCT01084083|O1|Outcome|Primary Study Population|The primary study population for this endpoint is patients who were confirmed post-induction clinical complete response (CR) at their primary sites and subsequently received 5400 cGy radiation therapy to their primary sites.
363467|NCT01084135|B1|Baseline|20 Week Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
363468|NCT01084135|P2|Participant Flow|Liquid Placebo|"Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.~Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste."
363469|NCT01084135|P1|Participant Flow|Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
363470|NCT01084135|O2|Outcome|Liquid Placebo|"Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.~Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste."
363471|NCT01084135|O1|Outcome|Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
363472|NCT01084135|O2|Outcome|Liquid Placebo|"Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.~Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste."
363473|NCT01084135|O1|Outcome|Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
363474|NCT01084135|E4|Reported Event|12 Week: Liquid Placebo|Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.
363475|NCT01084135|E3|Reported Event|12 Week: Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional four weeks. At the week 6 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 6 weeks.
363476|NCT01084135|E2|Reported Event|20 Week: Liquid Placebo|Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.
363477|NCT01084135|E1|Reported Event|20 Week: Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
363478|NCT01084083|B1|Baseline|Eligible and Treated Patients|Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
363479|NCT01084083|P1|Participant Flow|Overall|Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
363480|NCT01084083|O1|Outcome|Eligible and Treated Patients|Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
363481|NCT01084083|O1|Outcome|Eligible and Treated Patients|Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
363531|NCT01083901|O2|Outcome|Ibuprofen and Resistance Exercise Training|
363483|NCT01084083|E1|Reported Event|All Treated Patients|"Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.~Adverse events data were reported for all patients received at least one dose of protocol therapy."
363484|NCT01084005|B3|Baseline|Total|Total of all reporting groups
363485|NCT01084005|B2|Baseline|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
363486|NCT01084005|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
363487|NCT01084005|P2|Participant Flow|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
363488|NCT01084005|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
363489|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
363490|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
363491|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
363492|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
363493|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
363494|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
363495|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
363496|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
363497|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
363498|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
363499|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
363500|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
363501|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
363502|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
363503|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
363504|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
363505|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
363506|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
363507|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
363508|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
363509|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
363510|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
363511|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
363512|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
363513|NCT01084005|E2|Reported Event|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
363514|NCT01084005|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
363515|NCT01083979|B1|Baseline|Liposomes|Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.
363516|NCT01083979|P1|Participant Flow|Liposomes|Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.
363517|NCT01083979|O1|Outcome|Liposomes|Intravesical instillation of Liposomes in sterile water totalling 40 cc at four weekly treatments.
363518|NCT01083979|O1|Outcome|Liposomes|Intravesical instillation of Liposomes in sterile water totalling 40 cc at four weekly treatments.
363519|NCT01083979|E1|Reported Event|Liposomes|Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.
363520|NCT01083901|B4|Baseline|Total|Total of all reporting groups
363521|NCT01083901|B3|Baseline|Placebo and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and placebo pills (matching active study drug) taken 2 hours before exercise on exercise days for up to 36 weeks.
363522|NCT01083901|B2|Baseline|Ibuprofen and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and administration of acetaminophen, 400 mg, taken 2 hours before exercise on exercise days for up to 36 weeks.
363523|NCT01083901|B1|Baseline|Acetaminophen and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and administration of acetaminophen, 1000 mg, taken 2 hours before exercise on exercise days for up to 36 weeks.
363524|NCT01083901|P3|Participant Flow|Placebo and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and placebo pills (matching active study drug) taken 2 hours before exercise on exercise days for up to 36 weeks.
363525|NCT01083901|P2|Participant Flow|Ibuprofen and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and administration of acetaminophen, 400 mg, taken 2 hours before exercise on exercise days for up to 36 weeks.
363526|NCT01083901|P1|Participant Flow|Acetaminophen and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and administration of acetaminophen, 1000 mg, taken 2 hours before exercise on exercise days for up to 36 weeks.
363527|NCT01083901|O3|Outcome|Placebo and Resistance Exercise Training|
363528|NCT01083901|O2|Outcome|Ibuprofen and Resistance Exercise Training|
363529|NCT01083901|O1|Outcome|Acetaminophen and Resistance Exercise Training|
363530|NCT01083901|O3|Outcome|Placebo and Resistance Exercise Training|
363532|NCT01083901|O1|Outcome|Acetaminophen and Resistance Exercise Training|
363533|NCT01083901|O3|Outcome|Placebo and Resistance Exercise Training|
363534|NCT01083901|O2|Outcome|Ibuprofen and Resistance Exercise Training|
363535|NCT01083901|O1|Outcome|Acetaminophen and Resistance Exercise Training|
363536|NCT01083901|O3|Outcome|Placebo and Resistance Exercise Training|
363537|NCT01083901|O2|Outcome|Ibuprofen and Resistance Exercise Training|
363538|NCT01083901|O1|Outcome|Acetaminophen and Resistance Exercise Training|
363539|NCT01083901|E3|Reported Event|Placebo and Resistance Exercise Training|
363540|NCT01083901|E2|Reported Event|Ibuprofen and Resistance Exercise Traininig|
363541|NCT01083901|E1|Reported Event|Acetaminophen and Resistance Exercise Training|
363542|NCT01083849|B3|Baseline|Total|Total of all reporting groups
363543|NCT01083849|B2|Baseline|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
363544|NCT01083849|B1|Baseline|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
363545|NCT01083849|P2|Participant Flow|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
363546|NCT01083849|P1|Participant Flow|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
363547|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
363548|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
363549|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
363550|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
363551|NCT01083849|O1|Outcome|Paricalcitol|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, not treated with paricalcitol for at least 6 months prior inclusion in this study, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
363552|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
363553|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
363554|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
363555|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
363556|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
363557|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
363558|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
363559|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
363560|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, prescribed on an on-label basis in an everyday setting. Participants were observed for 12 months.
363561|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, prescribed on an on-label basis in an everyday setting. Participants were observed for 12 months.
363562|NCT01083849|O1|Outcome|Paricalcitol|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, not treated with paricalcitol for at least 6 months prior inclusion in this study, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
370626|NCT01067976|O1|Outcome|CMRM vs UMRM|
363563|NCT01083849|E2|Reported Event|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
363564|NCT01083849|E1|Reported Event|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
363565|NCT01083810|B4|Baseline|Total|Total of all reporting groups
363566|NCT01083810|B3|Baseline|Non-B|Participants infected with non-B subtypes of HIV-1.
363567|NCT01083810|B2|Baseline|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
363568|NCT01083810|B1|Baseline|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
363569|NCT01083810|P3|Participant Flow|Non-B|Participants infected with non-B subtypes of HIV-1.
363570|NCT01083810|P2|Participant Flow|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
363571|NCT01083810|P1|Participant Flow|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
363572|NCT01083810|O3|Outcome|Non-B|Participants infected with non-B subtypes of HIV-1.
363573|NCT01083810|O2|Outcome|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
363574|NCT01083810|O1|Outcome|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
363575|NCT01083810|O3|Outcome|Non-B|Participants infected with non-B subtypes of HIV-1.
363576|NCT01083810|O2|Outcome|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
363577|NCT01083810|O1|Outcome|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
363578|NCT01083810|O3|Outcome|Non-B|Participants infected with non-B subtypes of HIV-1.
363579|NCT01083810|O2|Outcome|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
363580|NCT01083810|O1|Outcome|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
363581|NCT01083810|O3|Outcome|Non-B|Participants infected with non-B subtypes of HIV-1.
363582|NCT01083810|O2|Outcome|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
363583|NCT01083810|O1|Outcome|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
363584|NCT01083810|O3|Outcome|Non-B|Participants infected with non-B subtypes of HIV-1.
363585|NCT01083810|O2|Outcome|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
363586|NCT01083810|O1|Outcome|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
363587|NCT01083810|O3|Outcome|Non-B|Participants infected with non-B subtypes of HIV-1.
363588|NCT01083810|O2|Outcome|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
363589|NCT01083810|O1|Outcome|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
363590|NCT01083810|E1|Reported Event|HIV-infected Patients|Participants with HIV-1 infection, pooled from 3 studies in different populations conducted in parallel: KAL1RO (therapy-naive, NCT01083810, n=137), KAL2RO /KAL5RO (pre-treated, NCT01083836, n=92), and KAL6RO (non-B subtype, NCT01081470, n=55).
363591|NCT01083771|B1|Baseline|Olive Oil|"At least 3 tablespoons of olive oil each day~Olive Oil: Minimum of 3 tablespoon of olive oil per day"
363592|NCT01083771|P1|Participant Flow|Olive Oil|"At least 3 tablespoons of olive oil each day~Olive Oil: Minimum of 3 tablespoon of olive oil per day"
363593|NCT01083771|O1|Outcome|Olive Oil|"At least 3 tablespoons of olive oil each day~Olive Oil: Minimum of 3 tablespoon of olive oil per day"
363594|NCT01083771|O1|Outcome|Olive Oil|"At least 3 tablespoons of olive oil each day~Olive Oil: Minimum of 3 tablespoon of olive oil per day"
363595|NCT01083771|E1|Reported Event|Olive Oil|"At least 3 tablespoons of olive oil each day~Olive Oil: Minimum of 3 tablespoon of olive oil per day"
363596|NCT01083758|B1|Baseline|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363597|NCT01083758|P1|Participant Flow|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363598|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363599|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363600|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363601|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363602|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363603|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363604|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363605|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363606|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363607|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363608|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363609|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363610|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363611|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363612|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363613|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363614|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363615|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363616|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363617|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363618|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363619|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363620|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363621|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363622|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363623|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363624|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363625|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363626|NCT01083758|E1|Reported Event|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
363627|NCT01083732|B4|Baseline|Total|Total of all reporting groups
363628|NCT01083732|B3|Baseline|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363629|NCT01083732|B2|Baseline|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363630|NCT01083732|B1|Baseline|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363631|NCT01083732|P3|Participant Flow|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363632|NCT01083732|P2|Participant Flow|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363633|NCT01083732|P1|Participant Flow|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years):|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363634|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363635|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363636|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363637|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363638|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363639|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363640|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363641|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363642|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363643|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363644|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363645|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363646|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363647|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363648|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363649|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363650|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363651|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363697|NCT01083693|O3|Outcome|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
363652|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363653|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363654|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363655|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363656|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363657|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363658|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation).
363659|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363660|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363661|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363662|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363663|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363664|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363665|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363666|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363667|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363668|NCT01083732|O2|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363669|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <12 Years)|The patients aged 1 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363670|NCT01083732|O2|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363671|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <12 Years)|The patients aged 1 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363698|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
363672|NCT01083732|O2|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363673|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <12 Years)|The patients aged 1 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363674|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363675|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363676|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363677|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363678|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363679|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363680|NCT01083732|E3|Reported Event|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363681|NCT01083732|E2|Reported Event|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363682|NCT01083732|E1|Reported Event|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
363683|NCT01083706|B1|Baseline|Treatment (Chemotherapy)|"Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~laboratory biomarker analysis: Correlative studies"
363684|NCT01083706|P1|Participant Flow|Treatment (Chemotherapy)|"Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~laboratory biomarker analysis: Correlative studies"
363685|NCT01083706|O1|Outcome|Treatment (Chemotherapy)|"Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~laboratory biomarker analysis: Correlative studies"
363686|NCT01083706|O1|Outcome|Treatment (Chemotherapy)|"Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~laboratory biomarker analysis: Correlative studies"
363687|NCT01083706|O1|Outcome|Treatment (Chemotherapy)|"Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~laboratory biomarker analysis: Correlative studies"
363688|NCT01083706|E1|Reported Event|Treatment (Chemotherapy)|"Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~laboratory biomarker analysis: Correlative studies"
363689|NCT01083693|B4|Baseline|Total|Total of all reporting groups
363690|NCT01083693|B3|Baseline|Ankylosing Spondylitis (AS)|Ankylosing Spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
363691|NCT01083693|B2|Baseline|Psoriasis Arthritis (PsA)|Psoriatic Arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
363692|NCT01083693|B1|Baseline|Rheumatoid Arthritis (RA)|Rheumatoid Arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
363693|NCT01083693|P3|Participant Flow|Ankylosing Spondylitis (AS)|Ankylosing Spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
363694|NCT01083693|P2|Participant Flow|Psoriasis Arthritis (PsA)|Psoriatic Arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
363695|NCT01083693|P1|Participant Flow|Rheumatoid Arthritis (RA)|Rheumatoid Arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
363696|NCT01083693|O4|Outcome|Total|
363699|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
363700|NCT01083693|O4|Outcome|Total|
363701|NCT01083693|O3|Outcome|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
363702|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
363703|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
363704|NCT01083693|O3|Outcome|Total|
363705|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
363706|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
363707|NCT01083693|O3|Outcome|Total|
363708|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
363709|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
363710|NCT01083693|O1|Outcome|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
363711|NCT01083693|O3|Outcome|Total|
363712|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
363713|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
363714|NCT01083693|O4|Outcome|Total|
363715|NCT01083693|O3|Outcome|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
363716|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
363717|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
363718|NCT01083693|O4|Outcome|Total|
363719|NCT01083693|O3|Outcome|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
363720|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
363721|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
363722|NCT01083693|O3|Outcome|Total|
363723|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
363724|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
363725|NCT01083693|E4|Reported Event|Total|
363726|NCT01083693|E3|Reported Event|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
363727|NCT01083693|E2|Reported Event|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
363728|NCT01083693|E1|Reported Event|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
363729|NCT01083680|B1|Baseline|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
363730|NCT01083680|P1|Participant Flow|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
363731|NCT01083680|O1|Outcome|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
363732|NCT01083680|O1|Outcome|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
363733|NCT01083680|O1|Outcome|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
363734|NCT01083680|O1|Outcome|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
363735|NCT01083680|O1|Outcome|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
363736|NCT01083680|O1|Outcome|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
363737|NCT01083680|E1|Reported Event|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
363738|NCT01083667|B1|Baseline|Pyrimethamine|"Open label. Only one arm will receive the intervention.~Pyrimethamine: Open Label, dose escalating,"
363739|NCT01083667|P1|Participant Flow|Pyrimethamine|"Open label. Only one arm will receive the intervention.~Pyrimethamine: Open Label, dose escalating,"
363740|NCT01083667|O1|Outcome|Pyrimethamine|"Open label. Only one arm will receive the intervention.~Pyrimethamine: Open Label, dose escalating,"
363741|NCT01083667|O1|Outcome|Pyrimethamine|"Open label. Only one arm will receive the intervention.~Pyrimethamine: Open Label, dose escalating,"
363742|NCT01083667|E1|Reported Event|Pyrimethamine|"Open label. Only one arm will receive the intervention.~Pyrimethamine: Open Label, dose escalating,"
363743|NCT01083654|B3|Baseline|Total|Total of all reporting groups
363744|NCT01083654|B2|Baseline|Culturally-Tailored Treatment|"The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol of long life)"
363745|NCT01083654|B1|Baseline|Standard Treatment Counseling|"Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~ST Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by an enrolled member of the Menominee Tribe but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling."
363746|NCT01083654|P2|Participant Flow|Culturally-Tailored Treatment|"The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~Culturally-Tailored Treatment: The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol"
363747|NCT01083654|P1|Participant Flow|Standard Treatment Counseling|"Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~Standard Treatment Counseling: Standard Treatment Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by Ms. Fossum (an enrolled member of the Menominee Tribe) but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling. In other w"
363748|NCT01083654|O2|Outcome|Culturally-Tailored Treatment|"The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of four sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~Culturally-Tailored Treatment: The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol"
363749|NCT01083654|O1|Outcome|Standard Treatment Counseling|"Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~Standard Treatment Counseling: Standard Treatment Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by Ms. Fossum (an enrolled member of the Menominee Tribe) but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling. In other w"
363782|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
363783|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
363784|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
363785|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
363750|NCT01083654|E2|Reported Event|Culturally-Tailored Treatment|"The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of four sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~Culturally-Tailored Treatment: The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol"
363751|NCT01083654|E1|Reported Event|Standard Treatment Counseling|"Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~Standard Treatment Counseling: Standard Treatment Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by Ms. Fossum (an enrolled member of the Menominee Tribe) but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling. In other w"
363752|NCT01083641|B1|Baseline|Estrogen Therapy|"Estrogen therapy~Estradiol: 10mg oral three times daily"
363753|NCT01083641|P1|Participant Flow|Estrogen Therapy|"Estrogen therapy~Estradiol: 10mg oral three times daily"
363754|NCT01083641|O1|Outcome|Estrogen Therapy|"Estrogen therapy~Estradiol: 10mg oral three times daily"
363755|NCT01083641|O1|Outcome|Estrogen Therapy|"Estrogen therapy~Estradiol: 10mg oral three times daily"
363756|NCT01083641|O1|Outcome|Estrogen Therapy|"Estrogen therapy~Estradiol: 10mg oral three times daily"
363757|NCT01083641|O1|Outcome|Estrogen Therapy|"Estrogen therapy~Estradiol: 10mg oral three times daily"
363758|NCT01083641|E1|Reported Event|Estrogen Therapy|"Estrogen therapy~Estradiol: 10mg oral three times daily"
363759|NCT01083602|B1|Baseline|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
363760|NCT01083602|P1|Participant Flow|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
363761|NCT01083602|O1|Outcome|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
363762|NCT01083602|O1|Outcome|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
363763|NCT01083602|O1|Outcome|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
363764|NCT01083602|O1|Outcome|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
363765|NCT01083602|O1|Outcome|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
363766|NCT01083602|O1|Outcome|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
363767|NCT01083602|E1|Reported Event|PAN + BTZ + Dex|PAN + BTZ + Dex
363768|NCT01083576|B3|Baseline|Total|Total of all reporting groups
363769|NCT01083576|B2|Baseline|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
363770|NCT01083576|B1|Baseline|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
363771|NCT01083576|P2|Participant Flow|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
363772|NCT01083576|P1|Participant Flow|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated cutaneous leishmaniasis (CL) lesions once daily for 20 days
363773|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
363774|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated cutaneous leishmaniasis (CL) lesions once daily for 20 days
363775|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
363776|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated cutaneous leishmaniasis (CL) lesions once daily for 20 days
363777|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
363778|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
363779|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
363780|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
363781|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
370627|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
363786|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
363787|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
363788|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
363789|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
363790|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated cutaneous leishmaniasis (CL) lesions once daily for 20 days
363791|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
363792|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
363793|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
363794|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
363795|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
363796|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
363797|NCT01083576|E2|Reported Event|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
363798|NCT01083576|E1|Reported Event|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
363799|NCT01083485|B3|Baseline|Total|Total of all reporting groups
363800|NCT01083485|B2|Baseline|OXY Tablets|Oxycodone prolonged release (PR) 20mg or 10mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
363801|NCT01083485|B1|Baseline|OXN Tablets|Oxycodone/Naloxone prolonged release (PR) 20/10mg or 10/5mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
363802|NCT01083485|P2|Participant Flow|OXY Tablets|Oxycodone prolonged release (PR) 20mg or 10mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
363803|NCT01083485|P1|Participant Flow|OXN Tablets|Oxycodone/Naloxone prolonged release (PR) 20/10mg or 10/5mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
363804|NCT01083485|O2|Outcome|OXY Tablets|Oxycodone prolonged release (PR) 20mg or 10mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
363805|NCT01083485|O1|Outcome|OXN Tablets|Oxycodone/Naloxone prolonged release (PR) 20/10mg or 10/5mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
363806|NCT01083485|O2|Outcome|OXY Tablets|Oxycodone prolonged release (PR) 20mg or 10mg tablets twice a day (BID) for 2.5 days (total = 5 doses). Mean baseline pain score = 3.1
363807|NCT01083485|O1|Outcome|OXN Tablets|Oxycodone/Naloxone prolonged release (PR) 20/10mg or 10/5mg tablets twice a day (BID) for 2.5 days (total = 5 doses). Mean baseline pain score = 3.4
363808|NCT01083485|E2|Reported Event|OXY Tablets|Oxycodone prolonged release (PR) 20mg or 10mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
363809|NCT01083485|E1|Reported Event|OXN Tablets|Oxycodone/Naloxone prolonged release (PR) 20/10mg or 10/5mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
363810|NCT01083472|B3|Baseline|Total|Total of all reporting groups
363811|NCT01083472|B2|Baseline|Standard of Care Repair|Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh
363812|NCT01083472|B1|Baseline|Strattice(TM) TM Repair|Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
363813|NCT01083472|P2|Participant Flow|Standard of Care Repair|Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh
363814|NCT01083472|P1|Participant Flow|Strattice(TM) TM Repair|Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
363815|NCT01083472|O2|Outcome|Standard of Care Repair|Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh
363816|NCT01083472|O1|Outcome|Strattice(TM) TM Repair|Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
363817|NCT01083472|E2|Reported Event|Standard of Care Repair|Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh
363818|NCT01083472|E1|Reported Event|Strattice(TM) TM Repair|Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
363819|NCT01083316|B1|Baseline|Bortezomib and Dexamethasone|"Induction:~Bortezomib (Velcade) 1.3 mg/m2/dose intravenous (IV) Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1~Bortezomib (Velcade) and Dexamethasone: Induction:~Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days~Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4~Melphalan 70-100 mg/m2/day IV on days -2 and -1"
363820|NCT01083316|P1|Participant Flow|Bortezomib and Dexamethasone|"Induction:~Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1~Bortezomib (Velcade) and Dexamethasone: Induction:~Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days~Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4~Melphalan 70-100 mg/m2/day IV on days -2 and -1"
363821|NCT01083316|O1|Outcome|Bortezomib and Dexamethasone|"Induction:~Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1~Bortezomib (Velcade) and Dexamethasone: Induction:~Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days~Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4~Melphalan 70-100 mg/m2/day IV on days -2 and -1"
363822|NCT01083316|O1|Outcome|Bortezomib and Dexamethasone|"Induction:~Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1~Bortezomib (Velcade) and Dexamethasone: Induction:~Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days~Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4~Melphalan 70-100 mg/m2/day IV on days -2 and -1"
363823|NCT01083316|O1|Outcome|Bortezomib and Dexamethasone|"Induction:~Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1~Bortezomib (Velcade) and Dexamethasone: Induction:~Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days~Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4~Melphalan 70-100 mg/m2/day IV on days -2 and -1"
363824|NCT01083316|E1|Reported Event|Bortezomib and Dexamethasone|"Induction:~Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1~Bortezomib (Velcade) and Dexamethasone: Induction:~Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days~Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4~Melphalan 70-100 mg/m2/day IV on days -2 and -1"
363825|NCT01083199|B1|Baseline|AMS CONTINUUM™ Device|
363826|NCT01083199|P1|Participant Flow|AMS CONTINUUM™ Device|
363827|NCT01083199|O1|Outcome|AMS CONTINUUM™ Device|
363828|NCT01083199|O1|Outcome|Continuum Device|
363829|NCT01083199|E1|Reported Event|AMS CONTINUUM™ Device|
363830|NCT01083186|B1|Baseline|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
363831|NCT01083186|P1|Participant Flow|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
363832|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
363833|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
363834|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
363835|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
363836|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
363837|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
363838|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
363839|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
363840|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
363841|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
363842|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
363843|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
363844|NCT01083186|O4|Outcome|CKD Stage 5|Participants with chronic kidney disease stage 5 (eGFR <15 mL/min/1.73m^2)with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
363879|NCT01083173|O2|Outcome|Long-term Surveillance|All participants who received Kaletra treatment for at least 48 weeks
363845|NCT01083186|O3|Outcome|CKD Stage 4|Participants with chronic kidney disease stage 4 (eGFR 15-29 mL/min/1.73m^2)with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
363846|NCT01083186|O2|Outcome|CKD Stage 3|Participants with chronic kidney disease stage 3 (eGFR 30-59 mL/min/1.73m^2)with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
363847|NCT01083186|O1|Outcome|CKD Stage 2|Participants with chronic kidney disease stage 2 (eGFR 60-89 mL/min/1.73m^2) with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
363848|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
363849|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
363850|NCT01083186|O5|Outcome|"+++ Albuminuria at Month 12"|"The value +++ is taken directly from the dipstick measurements, and represents the highest albuminuria."
363851|NCT01083186|O4|Outcome|"++ Albuminuria at Month 12"|"The value ++ is taken directly from the dipstick measurements, and represents the value second to highest albuminuria."
363852|NCT01083186|O3|Outcome|"+ Albuminuria at Month 12"|"The value + is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria."
363853|NCT01083186|O2|Outcome|Trace Albuminuria at Month 12|"The value Trace is taken directly from the dipstick measurements, and represents a reading of trace albuminuria."
363854|NCT01083186|O1|Outcome|No Albuminuria at Month 12|"The value - is taken directly from the dipstick measurements, and represents a reading of no albuminuria."
363855|NCT01083186|O5|Outcome|"+++ Albuminuria at Month 6"|"The value +++ is taken directly from the dipstick measurements, and represents the highest albuminuria."
363856|NCT01083186|O4|Outcome|"++ Albuminuria at Month 6"|"The value ++ is taken directly from the dipstick measurements, and represents the value second to highest albuminuria."
363857|NCT01083186|O3|Outcome|"+ Albuminuria at Month 6"|"The value + is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria."
363858|NCT01083186|O2|Outcome|Trace Albuminuria at Month 6|"The value Trace is taken directly from the dipstick measurements, and represents a reading of trace albuminuria."
363859|NCT01083186|O1|Outcome|No Albuminuria at Month 6|"The value - is taken directly from the dipstick measurements, and represents a reading of no albuminuria."
363860|NCT01083186|O2|Outcome|Participants Outside of the Phosphorus Normal Range|Normal serum phosphorus range was 2.7-4.6 mg/dL.
363861|NCT01083186|O1|Outcome|Participants Within the Phosphorus Normal Range|Normal serum phosphorus range was 2.7-4.6 mg/dL.
363862|NCT01083186|O2|Outcome|Participants Outside of the Normal Calcium Range|Normal serum calcium range was 8.4-10.2 mg/dL.
363863|NCT01083186|O1|Outcome|Participants Within the Normal Calcium Range|Normal serum calcium range was 8.4-10.2 mg/dL.
363864|NCT01083186|O2|Outcome|Participants Out of the iPTH Target Range|Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.
363865|NCT01083186|O1|Outcome|Participants Within the iPTH Target Range|Number of participants with iPTH levels within the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.
363866|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
363867|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
363868|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
363869|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
363870|NCT01083186|E1|Reported Event|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
363871|NCT01083173|B1|Baseline|Overall Study|The main surveillance safety population included all participants who received at least one dose of Kaletra. The long-term surveillance safety population included participants who received Kaletra for more than 24 weeks.
363872|NCT01083173|P2|Participant Flow|Long-term Surveillance|The safety population included all participants who received Kaletra for more than 24 weeks, and the effectiveness population included all participants who received Kaletra treatment for at least 48 weeks.
363873|NCT01083173|P1|Participant Flow|Main Surveillance|The safety population included all participants who received at least one dose of Kaletra, and the effectiveness population included all participants who received Kaletra treatment for at least 24 weeks.
363874|NCT01083173|O1|Outcome|Long-term Surveillance|All participants who received Kaletra treatment for at least 48 weeks
363875|NCT01083173|O2|Outcome|Long-term Surveillance|All participants who received Kaletra treatment for at least 48 weeks
363876|NCT01083173|O1|Outcome|Main Surveillance|All participants who received Kaletra treatment for at least 24 weeks
363877|NCT01083173|O2|Outcome|Long-term Surveillance|All participants who received Kaletra treatment for at least 48 weeks
363878|NCT01083173|O1|Outcome|Main Surveillance|All participants who received Kaletra treatment for at least 24 weeks
370628|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
363880|NCT01083173|O1|Outcome|Main Surveillance|All participants who received Kaletra treatment for at least 24 weeks
363881|NCT01083173|O2|Outcome|Long-term Surveillance|Participants who received Kaletra for more than 24 weeks
363882|NCT01083173|O1|Outcome|Main Surveillance|All participants who received at least one dose of Kaletra
363883|NCT01083173|O1|Outcome|Main Surveillance|All participants who received Kaletra treatment for at least 24 weeks
363884|NCT01083173|O2|Outcome|Long-term Surveillance|Participants who received Kaletra for more than 24 weeks
363885|NCT01083173|O1|Outcome|Main Surveillance|All participants who received at least one dose of Kaletra
363886|NCT01083173|O2|Outcome|Long-term Surveillance|Participants who received Kaletra for more than 24 weeks
363887|NCT01083173|O1|Outcome|Main Surveillance|All participants who received at least one dose of Kaletra
363888|NCT01083173|E2|Reported Event|Long-term Surveillance|Participants who received Kaletra for more than 24 weeks
363889|NCT01083173|E1|Reported Event|Main Surveillance|All participants who received at least one dose of Kaletra
363890|NCT01083160|B1|Baseline|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
363891|NCT01083160|P1|Participant Flow|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
363892|NCT01083160|O1|Outcome|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
363893|NCT01083160|O1|Outcome|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
363894|NCT01083160|O1|Outcome|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
363895|NCT01083160|O1|Outcome|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
363896|NCT01083160|E1|Reported Event|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
363897|NCT01083121|B1|Baseline|Adalimumab|Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
363898|NCT01083121|P1|Participant Flow|Adalimumab|Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
363899|NCT01083121|O4|Outcome|Crohn's Disease|Participants with severely active Crohn's disease who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
363900|NCT01083121|O3|Outcome|Ankylosing Spondylitis|Participants with severe active ankylosing spondylitis who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
363901|NCT01083121|O2|Outcome|Psoriatic Arthritis|Participants with active and progressive psoriatic arthritis who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
363902|NCT01083121|O1|Outcome|Rheumatoid Arthritis|Participants with moderately to severely active rheumatoid arthritis who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
363903|NCT01083121|O1|Outcome|Adalimumab|Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
363904|NCT01083121|E1|Reported Event|Adalimumab|Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
363905|NCT01082965|B3|Baseline|Total|Total of all reporting groups
363906|NCT01082965|B2|Baseline|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
363907|NCT01082965|B1|Baseline|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
363908|NCT01082965|P2|Participant Flow|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
363909|NCT01082965|P1|Participant Flow|Donepezil|Donepezil 5 milligram (mg) tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
363910|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
363911|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
363912|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
363913|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
363914|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
363915|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
363916|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
363917|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
363918|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
365202|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
363919|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
363920|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
363921|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
363922|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
363923|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
363924|NCT01082965|E2|Reported Event|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
363925|NCT01082965|E1|Reported Event|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
363926|NCT01082952|B3|Baseline|Total|Total of all reporting groups
363927|NCT01082952|B2|Baseline|Non Asthmatic Patients|Non asthmatic patients with high eosinophil count (>3%).
363928|NCT01082952|B1|Baseline|Asthmatic Patients|Patients were severe asthmatic with high peripheral blood eosinophil counts (>5%).
363929|NCT01082952|P2|Participant Flow|Non Asthmatic Patients|Non asthmatic patients with high eosinophil count (>3%).
363930|NCT01082952|P1|Participant Flow|Asthmatic Patients|Patients were severe asthmatic with high peripheral blood eosinophil counts (>5%).
363931|NCT01082952|O2|Outcome|Non Asthmatic Patients|Non asthmatic patients with high Eosinophil count (>3%)
363932|NCT01082952|O1|Outcome|Asthmatic Patients|Mild asthmatic patients with high eosinophil count (>5%)
363933|NCT01082952|O2|Outcome|Non Asthmatic Patients|Non asthmatic patients with high Eosinophil count (>3%)
363934|NCT01082952|O1|Outcome|Asthmatic Patients|Mild asthmatic patients with high eosinophil count (>5%)
363935|NCT01082952|E2|Reported Event|Non Asthmatic Patients|Non asthmatic patients with high eosinophil count (>3%).
363936|NCT01082952|E1|Reported Event|Asthmatic Patients|Patients were severe asthmatic with high peripheral blood eosinophil counts (>5%).
363937|NCT01082939|B1|Baseline|CFAR|CFAR: Cyclophosphamide 250 mg/m^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1): 500 mg/m^2/day IV Day 2 over 4- 6 hours.
363938|NCT01082939|P1|Participant Flow|CFAR|CFAR: Cyclophosphamide 250 mg/m^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1): 500 mg/m^2/day IV Day 2 over 4- 6 hours.
363939|NCT01082939|O1|Outcome|CFAR|CFAR: Cyclophosphamide 250 mg/m^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1): 500 mg/m^2/day IV Day 2 over 4- 6 hours.
363940|NCT01082939|E1|Reported Event|CFAR|CFAR: Cyclophosphamide 250 mg/m^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1): 500 mg/m^2/day IV Day 2 over 4- 6 hours.
363941|NCT01082874|B5|Baseline|Total|Total of all reporting groups
363942|NCT01082874|B4|Baseline|Placebo Clonidine and Placebo ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
363943|NCT01082874|B3|Baseline|Placebo Clonidine and Active ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
363944|NCT01082874|B2|Baseline|Active Clonidine and Placebo ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
363945|NCT01082874|B1|Baseline|Active Clonidine and Active ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
363946|NCT01082874|P4|Participant Flow|Placebo Clonidine and Placebo ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
363947|NCT01082874|P3|Participant Flow|Placebo Clonidine and Active ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
363972|NCT01082640|O2|Outcome|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
363973|NCT01082640|O1|Outcome|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
365203|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
363948|NCT01082874|P2|Participant Flow|Active Clonidine and Placebo ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
363949|NCT01082874|P1|Participant Flow|Active Clonidine and Active ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
363950|NCT01082874|O4|Outcome|Placebo Clonidine and Placebo ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
363951|NCT01082874|O3|Outcome|Placebo Clonidine and Active ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
363952|NCT01082874|O2|Outcome|Active Clonidine and Placebo ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
363953|NCT01082874|O1|Outcome|Active Clonidine and Active ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
363954|NCT01082874|E4|Reported Event|Placebo Clonidine and Placebo ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
363955|NCT01082874|E3|Reported Event|Placebo Clonidine and Active ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
363956|NCT01082874|E2|Reported Event|Active Clonidine and Placebo ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
363957|NCT01082874|E1|Reported Event|Active Clonidine and Active ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
363958|NCT01082640|B4|Baseline|Total|Total of all reporting groups
363959|NCT01082640|B3|Baseline|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
363960|NCT01082640|B2|Baseline|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
363961|NCT01082640|B1|Baseline|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
363962|NCT01082640|P3|Participant Flow|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
363963|NCT01082640|P2|Participant Flow|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
363964|NCT01082640|P1|Participant Flow|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
363965|NCT01082640|O3|Outcome|Febuxostat 80 mg QD|Participants with serum urate levels ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD from the Month 1 visit through Month 12.
363966|NCT01082640|O2|Outcome|Febuxostat 40 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit.
363967|NCT01082640|O1|Outcome|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
363968|NCT01082640|O3|Outcome|Febuxostat 80 mg QD|Participants with serum urate levels ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD from the Month 1 visit through Month 12.
363969|NCT01082640|O2|Outcome|Febuxostat 40 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit.
363970|NCT01082640|O1|Outcome|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
363971|NCT01082640|O3|Outcome|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
363974|NCT01082640|O3|Outcome|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
363975|NCT01082640|O2|Outcome|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
363976|NCT01082640|O1|Outcome|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
363977|NCT01082640|O3|Outcome|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
363978|NCT01082640|O2|Outcome|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
363979|NCT01082640|O1|Outcome|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
363980|NCT01082640|E3|Reported Event|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
363981|NCT01082640|E2|Reported Event|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
363982|NCT01082640|E1|Reported Event|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
363983|NCT01082614|B3|Baseline|Total|Total of all reporting groups
363984|NCT01082614|B2|Baseline|Goal Directed Therapy|"Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis~Vigileo: Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV > 12%."
363985|NCT01082614|B1|Baseline|Standard Fluid Management|Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team
363986|NCT01082614|P2|Participant Flow|Goal Directed Therapy|"Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis~Vigileo: Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV > 12%."
363987|NCT01082614|P1|Participant Flow|Standard Fluid Management|Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team
363988|NCT01082614|O2|Outcome|Goal Directed Therapy|"Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis~Vigileo: Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV > 12%."
363989|NCT01082614|O1|Outcome|Standard Fluid Management|Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team
363990|NCT01082614|O2|Outcome|Goal Directed Therapy|"Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis~Vigileo: Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV > 12%."
363991|NCT01082614|O1|Outcome|Standard Fluid Management|Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team
363992|NCT01082614|O2|Outcome|Goal Directed Therapy|"Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis~Vigileo: Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV > 12%."
363993|NCT01082614|O1|Outcome|Standard Fluid Management|Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team
363994|NCT01082614|E2|Reported Event|Goal Directed Therapy|
363995|NCT01082614|E1|Reported Event|Standard Fluid Management|
363996|NCT01082588|B3|Baseline|Total|Total of all reporting groups
363997|NCT01082588|B2|Baseline|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
363998|NCT01082588|B1|Baseline|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
363999|NCT01082588|P2|Participant Flow|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
364000|NCT01082588|P1|Participant Flow|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
364001|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
364002|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
364003|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
364004|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
364005|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
364006|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
364007|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
364008|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
364009|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
364010|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
364011|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
365204|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
364012|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
364013|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
364014|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
364015|NCT01082588|E2|Reported Event|Placebo|"pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks~Placebo: pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks"
364016|NCT01082588|E1|Reported Event|Pravastatin|"pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks~Pravastatin: pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks"
364017|NCT01082575|B1|Baseline|Major Surgery|Post Operative patients
364018|NCT01082575|P1|Participant Flow|Major Surgery|Post Operative patients
364019|NCT01082575|O1|Outcome|General Care Floor|Observational General Care Floor Group
364020|NCT01082575|O1|Outcome|General Care Floor|Observational General Care Floor Group
364021|NCT01082575|E1|Reported Event|Major Surgery|Post Operative patients
364022|NCT01082380|B1|Baseline|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364023|NCT01082380|P1|Participant Flow|PF-02341066 250 mg|Single oral dose of PF-02341066 250 milligram (mg) containing 100 micro-curie (μCi) Carbon -14[14C].
364024|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364025|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364026|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364027|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364028|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364029|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364030|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364031|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364032|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364033|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364034|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364035|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364036|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364037|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364038|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364039|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364040|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364041|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364042|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364043|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364044|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364045|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364046|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364047|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364048|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364049|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364050|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364051|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364052|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364053|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364054|NCT01082380|E1|Reported Event|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
364055|NCT01082367|B3|Baseline|Total|Total of all reporting groups
364056|NCT01082367|B2|Baseline|Placebo/TOBI|Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
364107|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
364108|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
364109|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
364110|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
364057|NCT01082367|B1|Baseline|TOBI (Tobramycin Inhaled Solution)/Placebo|Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
364058|NCT01082367|P2|Participant Flow|Placebo/TOBI|Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
364059|NCT01082367|P1|Participant Flow|TOBI (Tobramycin Inhaled Solution)/Placebo|Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
364060|NCT01082367|O2|Outcome|Placebo/TOBI|Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
364061|NCT01082367|O1|Outcome|TOBI (Tobramycin Inhaled Solution)/Placebo|Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
364062|NCT01082367|O2|Outcome|Placebo/TOBI|Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
364063|NCT01082367|O1|Outcome|TOBI (Tobramycin Inhaled Solution)/Placebo|Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
364064|NCT01082367|O2|Outcome|Placebo/TOBI|Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
364111|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
364112|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
364403|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
364065|NCT01082367|O1|Outcome|TOBI (Tobramycin Inhaled Solution)/Placebo|Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
364066|NCT01082367|E6|Reported Event|Off-treatment (Follow-up)|Off-treatment (follow-up)
364067|NCT01082367|E5|Reported Event|OL TOBI (Follow-up)|OL TOBI (follow-up)
364068|NCT01082367|E4|Reported Event|Off-treatment (Core)|Off-treatment (core)
364069|NCT01082367|E3|Reported Event|OL TOBI (Core)|OL TOBI (core)
364070|NCT01082367|E2|Reported Event|DB Placebo|DB Placebo
364071|NCT01082367|E1|Reported Event|DB TOBI|DB TOBI
364072|NCT01082328|B1|Baseline|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
364073|NCT01082328|P1|Participant Flow|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
364074|NCT01082328|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
364075|NCT01082328|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
364076|NCT01082328|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
364077|NCT01082328|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
364078|NCT01082328|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
364079|NCT01082328|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
364080|NCT01082328|E1|Reported Event|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
364081|NCT01082211|B1|Baseline|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
364082|NCT01082211|P1|Participant Flow|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
364083|NCT01082211|O1|Outcome|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
364084|NCT01082211|O1|Outcome|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
364085|NCT01082211|O1|Outcome|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
364086|NCT01082211|O1|Outcome|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
364087|NCT01082211|O1|Outcome|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
364088|NCT01082211|O1|Outcome|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
364089|NCT01082211|O1|Outcome|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
364090|NCT01082211|O1|Outcome|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
364091|NCT01082211|E1|Reported Event|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
364092|NCT01082159|B1|Baseline|Lumbar Decompression|Single arm cohort having percutaneous decompression using the mild Device Kit
364093|NCT01082159|P1|Participant Flow|Lumbar Decompression|Single arm cohort having percutaneous decompression using the mild Device Kit
364094|NCT01082159|O1|Outcome|Lumbar Decompression|Single arm cohort having percutaneous decompression using the mild Device Kit
364095|NCT01082159|O1|Outcome|Lumbar Decompression|Single arm cohort having percutaneous lumbar decompression using the mild Device Kit.
364096|NCT01082159|O1|Outcome|Lumbar Decompression|Single arm cohort having percutaneous decompression using the mild Device Kit
364097|NCT01082159|E1|Reported Event|Lumbar Decompression|Single arm cohort having percutaneous decompression using the mild Device Kit
364098|NCT01082081|B4|Baseline|Total|Total of all reporting groups
364099|NCT01082081|B3|Baseline|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
364100|NCT01082081|B2|Baseline|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
364101|NCT01082081|B1|Baseline|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
364102|NCT01082081|P3|Participant Flow|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
364103|NCT01082081|P2|Participant Flow|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
364104|NCT01082081|P1|Participant Flow|Paracetamol Caplet 1000 Milligrams (mg)|Participants were administered with two paracetamol fast dissolving (FD) 500 mg caplets (total dose= 1000 mg), with 150 milliliter (mL) of water through oral route.
364105|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
364106|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
370629|NCT01067976|O1|Outcome|CMRM vs UMRM|
364113|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
364114|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
364115|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
364116|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
364117|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
364118|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
364119|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
364120|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
364121|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
364122|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
364123|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
364124|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
364125|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
364126|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
364127|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
364128|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
364129|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
364130|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
364131|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
364132|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
364133|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
364134|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
364135|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
364136|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
364137|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
364138|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
364139|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
364140|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
364141|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
364142|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
364143|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
364144|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
364145|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
364146|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
364147|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
364148|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
364149|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
364150|NCT01082081|E3|Reported Event|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
364182|NCT01081886|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
364151|NCT01082081|E2|Reported Event|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
364152|NCT01082081|E1|Reported Event|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
364153|NCT01081951|B3|Baseline|Total|Total of all reporting groups
364154|NCT01081951|B2|Baseline|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.~Followed by a post-completion phase in which no study treatment was administered"
364155|NCT01081951|B1|Baseline|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.~Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
364156|NCT01081951|P2|Participant Flow|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.~Followed by a post-completion phase in which no study treatment was administered"
364157|NCT01081951|P1|Participant Flow|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.~Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
364158|NCT01081951|O2|Outcome|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.~Followed by a post-completion phase in which no study treatment was administered"
364159|NCT01081951|O1|Outcome|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.~Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
364160|NCT01081951|O2|Outcome|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.~Followed by a post-completion phase in which no study treatment was administered"
364161|NCT01081951|O1|Outcome|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.~Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
364162|NCT01081951|O2|Outcome|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.~Followed by a post-completion phase in which no study treatment was administered"
364163|NCT01081951|O1|Outcome|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.~Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
364164|NCT01081951|E2|Reported Event|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.~Followed by a post-completion phase in which no study treatment was administered"
364165|NCT01081951|E1|Reported Event|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.~Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
364166|NCT01081912|B1|Baseline|Open-label Conversion/Titration Phase|Hydrocodone Bitartrate Extended Release capsules twice daily for up to 6 weeks (Open-Label)
364167|NCT01081912|P3|Participant Flow|Double-Blind Treatment Phase: Placebo Comparator|"Placebo: Capsules, no active substance, shells identical to active comparator capsules.~Placebo capsules twice daily for up to 12 weeks (Double-Blind Period)"
364168|NCT01081912|P2|Participant Flow|Double-Blind Treatment Phase|"Treatment Phase: Hydrocodone Bitartrate Controlled-Release Capsules twice daily up to 12 weeks (Double-Blind Period)~Hydrocodone bitartrate: dosage form: capsule~Strengths 10mg, 20mg, 30mg, 40mg, 50mg"
364169|NCT01081912|P1|Participant Flow|Conversion/Titration Phase - Open-Label|Conversion/Titration Phase: Hydrocodone Bitartrate Extended Release capsules twice daily for up to 6 weeks (Open-Label Period)
364170|NCT01081912|O2|Outcome|Placebo Comparator|Placebo: Capsules, no active substance, shells identical to active comparator capsules
364171|NCT01081912|O1|Outcome|Hydrocodone Bitartrate Capsules|"Hydrocodone Bitartrate Controlled-Release Capsules~Hydrocodone bitartrate: dosage form: capsule~Strengths 10mg, 20mg, 30mg, 40mg, 50mg"
364172|NCT01081912|E3|Reported Event|Double Blind Treatment Phase: Placebo Comparator|"Placebo: Capsules, no active substance, shells identical to active comparator capsules.~Placebo capsules twice daily for up to 12 weeks (Double-Blind Period)"
364173|NCT01081912|E2|Reported Event|Double Blind Treatment Phase: Hydrocodone Bitartrate Capsules|"Hydrocodone Bitartrate Controlled-Release Capsules twice daily up to 12 weeks (Double-Blind Period)~Hydrocodone bitartrate: dosage form: capsule~Strengths 10mg, 20mg, 30mg, 40mg, 50mg"
364174|NCT01081912|E1|Reported Event|Open-Label Conversion/Titration Phase|Hydrocodone Bitartrate Extended Release capsules twice daily for up to 6 weeks (Open-Label Period)
364175|NCT01081886|B3|Baseline|Total|Total of all reporting groups
364176|NCT01081886|B2|Baseline|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
364177|NCT01081886|B1|Baseline|PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
364178|NCT01081886|P2|Participant Flow|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
364179|NCT01081886|P1|Participant Flow|PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
364180|NCT01081886|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
364181|NCT01081886|O1|Outcome|PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
370630|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
364183|NCT01081886|O1|Outcome|PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
364184|NCT01081886|E2|Reported Event|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
364185|NCT01081886|E1|Reported Event|PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
364186|NCT01081873|B1|Baseline|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses. Age was available for 2,691 patients only; age was missing for 23 patients who were thus not included in the age results.
364187|NCT01081873|P1|Participant Flow|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
364188|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
364189|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
364190|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
364191|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
364192|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
364193|NCT01081873|O4|Outcome|Advanced Prostate Cancer Participants - MRI|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines who had tumor staging assessed via MRI.
364194|NCT01081873|O3|Outcome|Advanced Prostate Cancer Participants - Echograph|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines who had tumor staging assessed via an echograph (hyperechogenic zones).
364195|NCT01081873|O2|Outcome|Advanced Prostate Cancer Participants - Prostate Biopsy|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines who had tumor staging assessed via a prostate biopsy.
364196|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants - Rectal Examination|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines who had tumor staging assessed via rectal examination.
364197|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
364198|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants at Baseline|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a tissue type recorded at Baseline.
364199|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
364200|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
364201|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
364202|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
364203|NCT01081873|O10|Outcome|Advanced Prostate Cancer Participants - Use at Any Visit|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had used any of the treatments at any visit.
364204|NCT01081873|O9|Outcome|Advanced Prostate Cancer Participants at Month 24|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
364205|NCT01081873|O8|Outcome|Advanced Prostate Cancer Participants at Month 21|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
364206|NCT01081873|O7|Outcome|Advanced Prostate Cancer Participants at Month 18|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
364207|NCT01081873|O6|Outcome|Advanced Prostate Cancer Participants at Month 15|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
364308|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
364208|NCT01081873|O5|Outcome|Advanced Prostate Cancer Participants at Month 12|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
364209|NCT01081873|O4|Outcome|Advanced Prostate Cancer Participants at Month 9|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
364210|NCT01081873|O3|Outcome|Advanced Prostate Cancer Participants at Month 6|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
364211|NCT01081873|O2|Outcome|Advanced Prostate Cancer Participants at Month 3|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
364212|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants at Baseline|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
364213|NCT01081873|O10|Outcome|Advanced Prostate Cancer Participants - Last Available Record|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
364214|NCT01081873|O9|Outcome|Advanced Prostate Cancer Participants at Month 24|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
364215|NCT01081873|O8|Outcome|Advanced Prostate Cancer Participants at Month 21|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
364216|NCT01081873|O7|Outcome|Advanced Prostate Cancer Participants at Month 18|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
364217|NCT01081873|O6|Outcome|Advanced Prostate Cancer Participants at Month 15|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
364218|NCT01081873|O5|Outcome|Advanced Prostate Cancer Participants at Month 12|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
364219|NCT01081873|O4|Outcome|Advanced Prostate Cancer Participants at Month 9|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
364220|NCT01081873|O3|Outcome|Advanced Prostate Cancer Participants at Month 6|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
364221|NCT01081873|O2|Outcome|Advanced Prostate Cancer Participants at Month 3|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
364222|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants at Baseline|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
364223|NCT01081873|O9|Outcome|Advanced Prostate Cancer Participants - Last Available Record|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
364224|NCT01081873|O8|Outcome|Advanced Prostate Cancer Participants at Month 24|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
364225|NCT01081873|O7|Outcome|Advanced Prostate Cancer Participants at Month 21|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
364226|NCT01081873|O6|Outcome|Advanced Prostate Cancer Participants at Month 18|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
364227|NCT01081873|O5|Outcome|Advanced Prostate Cancer Participants at Month 15|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
364228|NCT01081873|O4|Outcome|Advanced Prostate Cancer Participants at Month 12|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
364229|NCT01081873|O3|Outcome|Advanced Prostate Cancer Participants at Month 9|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
364230|NCT01081873|O2|Outcome|Advanced Prostate Cancer Participants at Month 6|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
364231|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants at Month 3|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
364232|NCT01081873|O10|Outcome|Advanced Prostate Cancer Participants - Last Available Record|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
364233|NCT01081873|O9|Outcome|Advanced Prostate Cancer Participants at Month 24|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
364404|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
364234|NCT01081873|O8|Outcome|Advanced Prostate Cancer Participants at Month 21|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
364235|NCT01081873|O7|Outcome|Advanced Prostate Cancer Participants at Month 18|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
364236|NCT01081873|O6|Outcome|Advanced Prostate Cancer Participants at Month 15|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
364237|NCT01081873|O5|Outcome|Advanced Prostate Cancer Participants at Month 12|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
364238|NCT01081873|O4|Outcome|Advanced Prostate Cancer Participants at Month 9|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
364239|NCT01081873|O3|Outcome|Advanced Prostate Cancer Participants at Month 6|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
364240|NCT01081873|O2|Outcome|Advanced Prostate Cancer Participants at Month 3|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
364241|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants at Baseline|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
364242|NCT01081873|O10|Outcome|Advanced Prostate Cancer Participants - Last Available Record|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
364243|NCT01081873|O9|Outcome|Advanced Prostate Cancer Participants at Month 24|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
364244|NCT01081873|O8|Outcome|Advanced Prostate Cancer Participants at Month 21|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
364245|NCT01081873|O7|Outcome|Advanced Prostate Cancer Participants at Month 18|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
364246|NCT01081873|O6|Outcome|Advanced Prostate Cancer Participants at Month 15|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
364247|NCT01081873|O5|Outcome|Advanced Prostate Cancer Participants at Month 12|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
364248|NCT01081873|O4|Outcome|Advanced Prostate Cancer Participants at Month 9|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
364249|NCT01081873|O3|Outcome|Advanced Prostate Cancer Participants at Month 6|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
364250|NCT01081873|O2|Outcome|Advanced Prostate Cancer Participants at Month 3|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
364251|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants at Baseline|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
364252|NCT01081873|E1|Reported Event|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
364253|NCT01081834|B6|Baseline|Total|Total of all reporting groups
364254|NCT01081834|B5|Baseline|High Glycemic Substudy: Canagliflozin 300 mg|In the High Glycemic Substudy, each patient received 300 mg of canagliflozin once daily for 26 weeks.
364255|NCT01081834|B4|Baseline|High Glycemic Substudy: Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
364256|NCT01081834|B3|Baseline|Main Study: Canagliflozin 300 mg|In the Main Study, each patient received 300 mg of canagliflozin once daily for 52 weeks.
364257|NCT01081834|B2|Baseline|Main Study: Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
364258|NCT01081834|B1|Baseline|Main Study: Placebo/Sitagliptin|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
364259|NCT01081834|P5|Participant Flow|High Glycemic Substudy: Canagliflozin 300 mg|In the High Glycemic Substudy, each patient received 300 mg of canagliflozin once daily for 26 weeks only. No patients received treatment during the period Week 26 to Week 52.
364260|NCT01081834|P4|Participant Flow|High Glycemic Substudy: Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks only. No patients received treatment during the period Week 26 to Week 52.
364261|NCT01081834|P3|Participant Flow|Main Study: Canagliflozin 300 mg|In the Main Study, each patient received 300 mg of canagliflozin once daily for 52 weeks.
364262|NCT01081834|P2|Participant Flow|Main Study: Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
364309|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
364263|NCT01081834|P1|Participant Flow|Main Study: Placebo/Sitagliptin|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
364264|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
364265|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
364266|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
364267|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
364268|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
364269|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
364270|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
364271|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
364272|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
364273|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
364274|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
364275|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
364276|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
364277|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
364278|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
364279|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
364280|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
364281|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
364282|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
364283|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
364284|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
364285|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
364286|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
364287|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
364288|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
364289|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
364290|NCT01081834|O1|Outcome|Placebo|In the Main study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
364291|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
364292|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
364293|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
364294|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
364295|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
364296|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
364297|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
364298|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
364299|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
364300|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
364301|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
364302|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
364303|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
364304|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
364305|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient recieved matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
364306|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
364307|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
364310|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
364311|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient recieved matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
364312|NCT01081834|E8|Reported Event|High Glycemic Substudy (Baseline to Week 26): Cana 300 mg|Each patient received 300 mg of canagliflozin (Cana) once daily for 26 weeks. Data are only available for Baseline to Week 26.
364313|NCT01081834|E7|Reported Event|High Glycemic Substudy (Baseline to Week 26): Cana 100 mg|Each patient received 100 mg of canagliflozin (Cana) once daily for 26 weeks. Data are only available for Baseline to Week 26.
364314|NCT01081834|E6|Reported Event|Main Study (Baseline to Week 52): Cana 300 mg|Each patient received 300 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 52.
364315|NCT01081834|E5|Reported Event|Main Study (Baseline to Week 52): Cana 100 mg|Each patient received 100 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 52.
364316|NCT01081834|E4|Reported Event|Main Study (Baseline to Week 52): Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Data are presented for Baseline to Week 52.
364317|NCT01081834|E3|Reported Event|Main Study (Baseline to Week 26): Cana 300 mg|Each patient received 300 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 26.
364318|NCT01081834|E2|Reported Event|Main Study (Baseline to Week 26): Cana 100 mg|Each patient received 100 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 26.
364319|NCT01081834|E1|Reported Event|Main Study (Baseline to Week 26): Placebo|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Data are presented for Baseline to Week 26.
364320|NCT01081795|B4|Baseline|Total|Total of all reporting groups
364321|NCT01081795|B3|Baseline|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364322|NCT01081795|B2|Baseline|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364323|NCT01081795|B1|Baseline|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364324|NCT01081795|P3|Participant Flow|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364325|NCT01081795|P2|Participant Flow|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364326|NCT01081795|P1|Participant Flow|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364327|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364328|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364329|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364330|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364399|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
364400|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
364331|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364332|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364333|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364334|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364335|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364336|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364337|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364338|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364339|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364340|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364341|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364342|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364343|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364344|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364345|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364401|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
364402|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
364346|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364347|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364348|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364349|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364350|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364351|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364352|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364353|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364354|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364355|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364356|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364357|NCT01081795|E3|Reported Event|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364358|NCT01081795|E2|Reported Event|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364359|NCT01081795|E1|Reported Event|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
364360|NCT01081769|B3|Baseline|Total|Total of all reporting groups
364361|NCT01081769|B2|Baseline|Oral Antipsychotics|Oral antipsychotics daily treatment according to local label for maximally 24 months
364362|NCT01081769|B1|Baseline|Paliperidone Palmitate|2 weeks oral paliperidone treatment followed by intramuscular injection with 150 mg paliperidone palmitate equivalent on Day 1 of the core treatment phase, 100 mg equivalent on Day 8, 75 mg equivalent on Day 38 and flexible dosing with 25, 50, 75, 100 or 150 mg equivalent once monthly thereafter
364363|NCT01081769|P2|Participant Flow|Oral Antipsychotics|Oral antipsychotics daily treatment according to local label for maximally 24 months
364364|NCT01081769|P1|Participant Flow|Paliperidone Palmitate|2 weeks oral paliperidone treatment followed by intramuscular injection with 150 mg paliperidone palmitate equivalent on Day 1 of the core treatment phase, 100 mg equivalent on Day 8, 75 mg equivalent on Day 38 and flexible dosing with 25, 50, 75, 100 or 150 mg equivalent once monthly thereafter
364365|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
364366|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
364367|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
364368|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
364369|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
364370|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
364371|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
364372|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
364373|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
364374|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
364375|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
364376|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
364377|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
364378|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
364379|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
364380|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
364381|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
364382|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
364383|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
364384|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
364385|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
364386|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
364387|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
364388|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
364389|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
364390|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
364391|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
364392|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
364393|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
364394|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
364395|NCT01081769|E2|Reported Event|Oral Antipsychotics|Oral antipsychotics daily treatment according to local label for maximally 24 months
364396|NCT01081769|E1|Reported Event|Paliperidone Palmitate|2 weeks oral paliperidone treatment followed by intramuscular injection with 150 mg paliperidone palmitate equivalent on Day 1 of the core treatment phase, 100 mg equivalent on Day 8, 75 mg equivalent on Day 38 and flexible dosing with 25, 50, 75, 100 or 150 mg equivalent once monthly thereafter
364397|NCT01081665|B1|Baseline|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
364398|NCT01081665|P1|Participant Flow|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
364405|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
364406|NCT01081665|E1|Reported Event|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
364407|NCT01081626|B3|Baseline|Total|Total of all reporting groups
364408|NCT01081626|B2|Baseline|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364409|NCT01081626|B1|Baseline|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364410|NCT01081626|P2|Participant Flow|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364411|NCT01081626|P1|Participant Flow|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364412|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364413|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364414|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364415|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364416|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364417|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364418|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364419|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364420|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364421|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364422|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364423|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364424|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364425|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364426|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364427|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364428|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364429|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364501|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
364502|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
364430|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364431|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364432|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364433|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364434|NCT01081626|E2|Reported Event|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364435|NCT01081626|E1|Reported Event|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
364436|NCT01081301|B1|Baseline|Living With Hope Program|"The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
364437|NCT01081301|P1|Participant Flow|Living With Hope Program|"Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
364438|NCT01081301|O6|Outcome|Living With Hope Program [12 Months]|
364439|NCT01081301|O5|Outcome|Living With Hope Program [6 Months]|
364440|NCT01081301|O4|Outcome|Living With Hope Program [3 Months]|
364441|NCT01081301|O3|Outcome|Living With Hope Program [Day 14]|
364442|NCT01081301|O2|Outcome|Living With Hope Program [Day 7]|
364443|NCT01081301|O1|Outcome|Living With Hope Program [Baseline]|"Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
364444|NCT01081301|O6|Outcome|Living With Hope Program [12 Months]|
364445|NCT01081301|O5|Outcome|Living With Hope Program [6 Months]|
364446|NCT01081301|O4|Outcome|Living With Hope Program [3 Months]|
364447|NCT01081301|O3|Outcome|Living With Hope Program [Day 14]|
364448|NCT01081301|O2|Outcome|Living With Hope Program [Day 7]|
364449|NCT01081301|O1|Outcome|Living With Hope Program [Baseline]|"Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
364450|NCT01081301|O6|Outcome|Living With Hope Program [12 Months]|
364451|NCT01081301|O5|Outcome|Living With Hope Program [6 Months]|
364452|NCT01081301|O4|Outcome|Living With Hope Program [3 Months]|
364453|NCT01081301|O3|Outcome|Living With Hope Program [Day 14]|
364454|NCT01081301|O2|Outcome|Living With Hope Program [Day 7]|
364455|NCT01081301|O1|Outcome|Living With Hope Program [Baseline]|"Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
364456|NCT01081301|O6|Outcome|Living With Hope Program [12 Months]|"12 months Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
364457|NCT01081301|O5|Outcome|Living With Hope Program [6 Months]|"6 months Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
364728|NCT01080677|O3|Outcome|High Dose|Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
364458|NCT01081301|O4|Outcome|Living With Hope Program [3 Months]|"3 months Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
364459|NCT01081301|O3|Outcome|Living With Hope Program [Day 14]|"Day 14 Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
364460|NCT01081301|O2|Outcome|Living With Hope Program [Day 7]|"Day 7 Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
364461|NCT01081301|O1|Outcome|Living With Hope Program [Baseline]|Baseline Measure
364462|NCT01081301|O6|Outcome|Living With Hope Program [12 Months]|
364463|NCT01081301|O5|Outcome|Living With Hope Program [6 Months]|
364464|NCT01081301|O4|Outcome|Living With Hope Program [3 Months]|
364465|NCT01081301|O3|Outcome|Living With Hope Program [Day 14]|
364466|NCT01081301|O2|Outcome|Living With Hope Program [Day 7]|
364467|NCT01081301|O1|Outcome|Living With Hope Program [Baseline]|
364468|NCT01081301|E6|Reported Event|Living With Hope Program [12 Months]|
364469|NCT01081301|E5|Reported Event|Living With Hope Program [6 Months]|
364470|NCT01081301|E4|Reported Event|Living With Hope Program [3 Months]|
364471|NCT01081301|E3|Reported Event|Living With Hope Program [Day 14]|
364472|NCT01081301|E2|Reported Event|Living With Hope Program [Day 7]|
364473|NCT01081301|E1|Reported Event|Living With Hope Program [Baseline]|
364474|NCT01081249|B1|Baseline|Active Drug|"placebo~intranasal oxytocin: single dose of 40 IU intranasal oxytocin or similar volume of placebo~placebo: single dose of 40 IU intranasal oxytocin or similar volume of placebo"
364475|NCT01081249|P2|Participant Flow|Placebo Then Oxytocin|Participants received a single dose of intranasal placebo prior to the first psychotherapy session; prior to the second psychotherapy session the participants received a single dose of 40 IU intranasal oxytocin.
364476|NCT01081249|P1|Participant Flow|Oxytocin Then Placebo|Participants received a single dose of 40 IU intranasal oxytocin prior to the first psychotherapy session; prior to the second psychotherapy session they received a similar dose of intranasal placebo.
364477|NCT01081249|O2|Outcome|Active Drug|A dose of 40 IU intranasal oxytocin was administered prior to the psychotherapy session.
364478|NCT01081249|O1|Outcome|Placebo|A dose of intranasal placebo was administered prior to the psychotherapy session.
364479|NCT01081249|E2|Reported Event|Oxytocin Then Placebo|Participants received 40 IU intranasal oxytocin prior to the first psychotherapy session; prior to the second psychotherapy session they received a comparable dose of intranasal placebo spray.
364480|NCT01081249|E1|Reported Event|Placebo Then Oxytocin|Participants received intranasal placebo spray prior to the first psychotherapy session; prior to the second psychotherapy session they received 40 IU intranasal oxytocin.
364481|NCT01081145|B1|Baseline|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
364482|NCT01081145|P2|Participant Flow|Placebo|Administered as a once-daily oral dose
364483|NCT01081145|P1|Participant Flow|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
364484|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
364485|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
364486|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
364487|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
364488|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
364489|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
364490|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
364491|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
364492|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
364493|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
364494|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
364495|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
364496|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
364497|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
364498|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
364499|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
364500|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
365205|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
364503|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
364504|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
364505|NCT01081145|E3|Reported Event|Guanfacine Hydrochloride (Randomized-Withdrawal Phase)|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
364506|NCT01081145|E2|Reported Event|Placebo (Randomized-Withdrawal Phase)|Administered as a once-daily oral dose
364507|NCT01081145|E1|Reported Event|Guanfacine Hydrochloride (Open-Label Phase)|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
364508|NCT01081132|B3|Baseline|Total|Total of all reporting groups
364509|NCT01081132|B2|Baseline|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
364510|NCT01081132|B1|Baseline|PLACEBO|Orally administered a once-daily dose
364511|NCT01081132|P2|Participant Flow|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
364512|NCT01081132|P1|Participant Flow|PLACEBO|Orally administered a once-daily dose
364513|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
364514|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
364515|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
364516|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
364517|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
364518|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
364519|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
364520|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
364521|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
364522|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
364523|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
364524|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
364525|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
364526|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
364527|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
364528|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
364529|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
364530|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
364531|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
364532|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
364533|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
364534|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
364535|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
364536|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
364537|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
364538|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
364539|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
364540|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
364541|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
364542|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
364543|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
364544|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
364545|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
364546|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
364547|NCT01081132|E2|Reported Event|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
364548|NCT01081132|E1|Reported Event|PLACEBO|Orally administered a once-daily dose
364549|NCT01081041|B4|Baseline|Total|Total of all reporting groups
364550|NCT01081041|B3|Baseline|Part 2: Cetuximab (Manufactured by BI), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly BI-manufactured cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
364729|NCT01080677|O2|Outcome|Low Dose|Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
364730|NCT01080677|O1|Outcome|Placebo|Participants received placebo to match caffeine/propranolol (single dose)
365206|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
364551|NCT01081041|B2|Baseline|Part 2: Cetuximab (US Commercial), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
364552|NCT01081041|B1|Baseline|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
364553|NCT01081041|P3|Participant Flow|Part 2: Cetuximab (Manufactured by BI), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly BI-manufactured cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
364554|NCT01081041|P2|Participant Flow|Part 2: Cetuximab (US Commercial), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
364555|NCT01081041|P1|Participant Flow|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):~United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cisplatin (cis) 100 mg/m^2 or carboplatin (carbo) area under the curve (AUC) 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-Fluorouracil (5-FU): 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
364556|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
364557|NCT01081041|O1|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
364558|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
364559|NCT01081041|O1|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
364560|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
364561|NCT01081041|O1|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
364562|NCT01081041|O3|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
364563|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
364564|NCT01081041|O1|Outcome|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):~United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cisplatin (cis) 100 mg/m^2 or carboplatin (carbo) area under the curve (AUC) 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-Fluorouracil (5-FU): 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
364565|NCT01081041|O1|Outcome|All Participants (Cetuximab)|"United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~OR~Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly."
364566|NCT01081041|O3|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
364567|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
364568|NCT01081041|O1|Outcome|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):~United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cisplatin (cis) 100 mg/m^2 or carboplatin (carbo) area under the curve (AUC) 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-Fluorouracil (5-FU): 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
364569|NCT01081041|O3|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
364570|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
364571|NCT01081041|O1|Outcome|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):~United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cisplatin (cis) 100 mg/m^2 or carboplatin (carbo) area under the curve (AUC) 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-Fluorouracil (5-FU): 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
364572|NCT01081041|O3|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
364573|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
364574|NCT01081041|O1|Outcome|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):~United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cisplatin (cis) 100 mg/m^2 or carboplatin (carbo) area under the curve (AUC) 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-Fluorouracil (5-FU): 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
364575|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI),|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
364576|NCT01081041|O1|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
364577|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
364578|NCT01081041|O1|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
364579|NCT01081041|E3|Reported Event|Part 2: Cetuximab (Manufactured by BI), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly BI-manufactured cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
364580|NCT01081041|E2|Reported Event|Part 2: Cetuximab (US Commercial), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
364581|NCT01081041|E1|Reported Event|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
364582|NCT01080976|B3|Baseline|Total|Total of all reporting groups
364583|NCT01080976|B2|Baseline|Diabetologists|
364584|NCT01080976|B1|Baseline|Primary Care Physicians|
364585|NCT01080976|P2|Participant Flow|Diabetologists|
364586|NCT01080976|P1|Participant Flow|Primary Care Physicians|
364587|NCT01080976|O2|Outcome|Diabetologists|Doctors Specialized in Diabetes
364588|NCT01080976|O1|Outcome|Primary Care Physicians|Doctors from General Practice
364589|NCT01080976|O2|Outcome|Diabetologists|Doctors Specialized in Diabetes
364590|NCT01080976|O1|Outcome|Primary Care Physicians|Doctors from General Practice
364591|NCT01080976|E2|Reported Event|Diabetologists|
364592|NCT01080976|E1|Reported Event|Primary Care Physicians|
364593|NCT01080807|B3|Baseline|Total|Total of all reporting groups
364594|NCT01080807|B2|Baseline|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364595|NCT01080807|B1|Baseline|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364596|NCT01080807|P2|Participant Flow|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364597|NCT01080807|P1|Participant Flow|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364598|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
365207|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
364599|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364600|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364601|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364602|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364603|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364604|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364605|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364606|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364607|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364608|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364609|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364731|NCT01080677|E3|Reported Event|High Dose|Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
364732|NCT01080677|E2|Reported Event|Low Dose|Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
364610|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364611|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364612|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364613|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364614|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364615|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364616|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364617|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364618|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364619|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364620|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364733|NCT01080677|E1|Reported Event|Placebo|Participants received placebo to match caffeine/propranolol (single dose)
364734|NCT01080625|B4|Baseline|Total|Total of all reporting groups
364735|NCT01080625|B3|Baseline|Control|10 ml of normal saline is administered at the time of reperfusion
364621|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364622|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364623|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364624|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364625|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364626|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364627|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364628|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364629|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364630|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364631|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364736|NCT01080625|B2|Baseline|Epinephrine|10 mcg of epinephrine is administered iv at the time of reperfusion
364737|NCT01080625|B1|Baseline|Phenylephrine|100 mcg of phenylephrine is administered at the time of reperfusion
364738|NCT01080625|P3|Participant Flow|Control|10 ml of normal saline is administered at the time of reperfusion
364632|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364633|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364634|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364635|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364636|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364637|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364638|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364639|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364640|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364641|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364642|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364739|NCT01080625|P2|Participant Flow|Epinephrine|10 mcg of epinephrine is administered iv at the time of reperfusion
364740|NCT01080625|P1|Participant Flow|Phenylephrine|100 mcg of phenylephrine is administered at the time of reperfusion
364741|NCT01080625|O3|Outcome|Control|10 ml of normal saline is administered at the time of reperfusion
364643|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364644|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364645|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364646|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364647|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364648|NCT01080807|E2|Reported Event|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364649|NCT01080807|E1|Reported Event|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
364650|NCT01080794|B5|Baseline|Total|Total of all reporting groups
364651|NCT01080794|B4|Baseline|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364652|NCT01080794|B3|Baseline|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364742|NCT01080625|O2|Outcome|Epinephrine|10 mcg of epinephrine is administered iv at the time of reperfusion
364743|NCT01080625|O1|Outcome|Phenylephrine|100 mcg of phenylephrine is administered at the time of reperfusion
364744|NCT01080625|E3|Reported Event|Control|10 ml of normal saline is administered at the time of reperfusion
364745|NCT01080625|E2|Reported Event|Epinephrine|10 mcg of epinephrine is administered iv at the time of reperfusion
364746|NCT01080625|E1|Reported Event|Phenylephrine|100 mcg of phenylephrine is administered at the time of reperfusion
364747|NCT01080391|B3|Baseline|Total|Total of all reporting groups
365137|NCT01079598|O1|Outcome|Treatment|RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
364653|NCT01080794|B2|Baseline|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364654|NCT01080794|B1|Baseline|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364655|NCT01080794|P4|Participant Flow|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364656|NCT01080794|P3|Participant Flow|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364657|NCT01080794|P2|Participant Flow|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364658|NCT01080794|P1|Participant Flow|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364659|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364792|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
364793|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
364794|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
365208|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
364660|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364661|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364662|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364663|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364664|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364665|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364666|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364795|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
364796|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
364797|NCT01080261|E1|Reported Event|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
365209|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
364667|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364668|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364669|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364670|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364671|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364672|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364673|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364798|NCT01080248|B1|Baseline|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.~Pazopanib 800 mg PO daily of each 28 day cycle."
364799|NCT01080248|P1|Participant Flow|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.~Pazopanib 800 mg PO daily of each 28 day cycle."
364800|NCT01080248|O1|Outcome|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.~Pazopanib 800 mg PO daily of each 28 day cycle."
364674|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364675|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364676|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364677|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364678|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364679|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364680|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364801|NCT01080248|O1|Outcome|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.~Pazopanib 800 mg PO daily of each 28 day cycle."
364802|NCT01080248|O1|Outcome|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.~Pazopanib 800 mg PO daily of each 28 day cycle."
364803|NCT01080248|O1|Outcome|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.~Pazopanib 800 mg PO daily of each 28 day cycle."
364681|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364682|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364683|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364684|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364685|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364686|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364687|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364804|NCT01080248|E1|Reported Event|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.~Pazopanib 800 mg PO daily of each 28 day cycle."
364805|NCT01080209|B8|Baseline|Total|Total of all reporting groups
364806|NCT01080209|B7|Baseline|Sham|Patients who received sham in a previous study.
364807|NCT01080209|B6|Baseline|Brimo PS DDS® 50 μg (1 Implant)|Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
370631|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
364688|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364689|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364690|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364691|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364692|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364693|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364694|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364808|NCT01080209|B5|Baseline|Brimo PS DDS® 100 μg (1 Implant)|Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
364809|NCT01080209|B4|Baseline|Brimo PS DDS® 200 μg (1 Implant)|Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
364810|NCT01080209|B3|Baseline|Brimo PS DDS® 200 μg (2 Implants)|Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
365210|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
364695|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364696|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364697|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364698|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364699|NCT01080794|E4|Reported Event|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364700|NCT01080794|E3|Reported Event|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364701|NCT01080794|E2|Reported Event|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364811|NCT01080209|B2|Baseline|Brimo PS DDS® 400 μg (1 Implant)|Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
364812|NCT01080209|B1|Baseline|Brimo PS DDS® 400 μg (2 Implants)|Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
364813|NCT01080209|P7|Participant Flow|Sham|Patients who received sham in a previous study.
365138|NCT01079598|E1|Reported Event|Treatment|RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
364702|NCT01080794|E1|Reported Event|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
364703|NCT01080768|B3|Baseline|Total|Total of all reporting groups
364704|NCT01080768|B2|Baseline|Amlodipine+ Placebo to Aliskiren/Amlodipine|"During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
364705|NCT01080768|B1|Baseline|Aliskiren/Amlodipine + Placebo to Amlodipine|"During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
364706|NCT01080768|P2|Participant Flow|Amlodipine+ Placebo to Aliskiren/Amlodipine|"During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
364707|NCT01080768|P1|Participant Flow|Aliskiren/Amlodipine + Placebo to Amlodipine|"During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
364708|NCT01080768|O2|Outcome|Amlodipine+ Placebo to Aliskiren/Amlodipine|"During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
364709|NCT01080768|O1|Outcome|Aliskiren/Amlodipine + Placebo to Amlodipine|"During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
364710|NCT01080768|E2|Reported Event|Amlodipine and Placebo to Aliskiren/Amlodipine|"During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patient up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
364711|NCT01080768|E1|Reported Event|Aliskiren/Amlodipine and Placebo to Amlodipine|"During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patient up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
364712|NCT01080677|B4|Baseline|Total|Total of all reporting groups
364713|NCT01080677|B3|Baseline|High Dose|Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
364714|NCT01080677|B2|Baseline|Low Dose|Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
364715|NCT01080677|B1|Baseline|Placebo|Participants received placebo to match caffeine/propranolol (single dose)
364716|NCT01080677|P3|Participant Flow|High Dose|Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
364717|NCT01080677|P2|Participant Flow|Low Dose|Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
364718|NCT01080677|P1|Participant Flow|Placebo|Participants received placebo to match caffeine/propranolol (single dose)
364719|NCT01080677|O3|Outcome|High Dose|Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
364720|NCT01080677|O2|Outcome|Low Dose|Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
364721|NCT01080677|O1|Outcome|Placebo|Participants received placebo to match caffeine/propranolol (single dose)
364722|NCT01080677|O3|Outcome|High Dose|Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
364723|NCT01080677|O2|Outcome|Low Dose|Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
364724|NCT01080677|O1|Outcome|Placebo|Participants received placebo to match caffeine/propranolol (single dose)
364725|NCT01080677|O3|Outcome|High Dose|Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
364726|NCT01080677|O2|Outcome|Low Dose|Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
364727|NCT01080677|O1|Outcome|Placebo|Participants received placebo to match caffeine/propranolol (single dose)
364748|NCT01080391|B2|Baseline|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
364749|NCT01080391|B1|Baseline|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
364750|NCT01080391|P2|Participant Flow|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
364751|NCT01080391|P1|Participant Flow|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
364752|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
364753|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
364754|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
364755|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
364756|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
364757|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
364758|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
364759|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
364760|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
364761|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
364762|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
364763|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
364764|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
364765|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
364766|NCT01080391|E2|Reported Event|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
364767|NCT01080391|E1|Reported Event|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
364768|NCT01080326|B1|Baseline|Endoscopic Translumenal Omental Patch|"Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place.~Endoscopic Translumenal Omental Patch: The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place."
364769|NCT01080326|P1|Participant Flow|Endoscopic Translumenal Omental Patch|"Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place.~Endoscopic Translumenal Omental Patch: The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place."
364770|NCT01080326|O1|Outcome|Endoscopic Translumenal Omental Patch|"Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place.~Endoscopic Translumenal Omental Patch: The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place."
364771|NCT01080326|E1|Reported Event|Endoscopic Translumenal Omental Patch|"Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place.~Endoscopic Translumenal Omental Patch: The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place."
364772|NCT01080300|B3|Baseline|Total|Total of all reporting groups
364773|NCT01080300|B2|Baseline|Sugar Pill|Placebo 1800 mg
364774|NCT01080300|B1|Baseline|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
364775|NCT01080300|P2|Participant Flow|Sugar Pill|Placebo 1800 mg
364776|NCT01080300|P1|Participant Flow|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
364777|NCT01080300|O2|Outcome|Sugar Pill|Placebo 1800 mg
364778|NCT01080300|O1|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
364779|NCT01080300|O2|Outcome|Sugar Pill|Placebo 1800 mg
364780|NCT01080300|O1|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
364781|NCT01080300|E2|Reported Event|Sugar Pill|Placebo 1800 mg
364782|NCT01080300|E1|Reported Event|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
364783|NCT01080261|B1|Baseline|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
364784|NCT01080261|P1|Participant Flow|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
364785|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
364786|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
364787|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
364788|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
364789|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
364790|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
364791|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
364814|NCT01080209|P6|Participant Flow|Brimo PS DDS® 50 μg (1 Implant)|Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
364815|NCT01080209|P5|Participant Flow|Brimo PS DDS® 100 μg (1 Implant)|Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
364816|NCT01080209|P4|Participant Flow|Brimo PS DDS® 200 μg (1 Implant)|Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
364817|NCT01080209|P3|Participant Flow|Brimo PS DDS® 200 μg (2 Implants)|Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
364818|NCT01080209|P2|Participant Flow|Brimo PS DDS® 400 μg (1 Implant)|Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
364819|NCT01080209|P1|Participant Flow|Brimo PS DDS® 400 μg (2 Implants)|Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
364820|NCT01080209|O7|Outcome|Sham|Patients who received sham in a previous study.
364821|NCT01080209|O6|Outcome|Brimo PS DDS® 50 μg (1 Implant)|Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
364822|NCT01080209|O5|Outcome|Brimo PS DDS® 100 μg (1 Implant)|Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
364823|NCT01080209|O4|Outcome|Brimo PS DDS® 200 μg (1 Implant)|Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
364824|NCT01080209|O3|Outcome|Brimo PS DDS® 200 μg (2 Implants)|Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
364825|NCT01080209|O2|Outcome|Brimo PS DDS® 400 μg (1 Implant)|Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
364826|NCT01080209|O1|Outcome|Brimo PS DDS® 400 μg (2 Implants)|Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
364827|NCT01080209|O7|Outcome|Sham|Patients who received sham in a previous study.
364828|NCT01080209|O6|Outcome|Brimo PS DDS® 50 μg (1 Implant)|Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
364829|NCT01080209|O5|Outcome|Brimo PS DDS® 100 μg (1 Implant)|Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
364830|NCT01080209|O4|Outcome|Brimo PS DDS® 200 μg (1 Implant)|Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
364831|NCT01080209|O3|Outcome|Brimo PS DDS® 200 μg (2 Implants)|Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
364832|NCT01080209|O2|Outcome|Brimo PS DDS® 400 μg (1 Implant)|Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
364833|NCT01080209|O1|Outcome|Brimo PS DDS® 400 μg (2 Implants)|Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
364834|NCT01080209|E7|Reported Event|Sham|Patients who received sham in a previous study.
364835|NCT01080209|E6|Reported Event|Brimo PS DDS® 50 μg (1 Implant)|Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
364836|NCT01080209|E5|Reported Event|Brimo PS DDS® 100 μg (1 Implant)|Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
364837|NCT01080209|E4|Reported Event|Brimo PS DDS® 200 μg (1 Implant)|Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
364838|NCT01080209|E3|Reported Event|Brimo PS DDS® 200 μg (2 Implants)|Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
364839|NCT01080209|E2|Reported Event|Brimo PS DDS® 400 μg (1 Implant)|Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
364840|NCT01080209|E1|Reported Event|Brimo PS DDS® 400 μg (2 Implants)|Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
364841|NCT01080196|B3|Baseline|Total|Total of all reporting groups
364842|NCT01080196|B2|Baseline|TRADITIONAL|The TRAD group will perform their lower extremity resistance exercise for 15 minutes per session with isotonic weight machines and cuff weights as part of their MCERFP. The progression of the 3 x/week, 12 week TRAD program will be determined as a relative function of their 1 repetition maximum (RM) weight that can be lifted in a safe and successful manner. The 1RM will be measured before the 12 week training program and every 2 weeks thereafter. A “target” resistance workload (i.e., weight level) commensurate with 60-70% of the 1RM of the knee and hip extensors will be calculated bi-monthly and 3 sets of 15 repetitions of 3-4 different knee and hip exercises will be used over a 15 minute time period.
364843|NCT01080196|B1|Baseline|RENEW|RENEW will occur on a recumbent ergometer that appears like a normal stepper ergometer. While resisting the foot pedal movement the participant experiences eccentric muscle contractions about the knee and hip while performing negative work. The progression of the 3 x/week (every other day), 12 week RENEW program will be determined as a function of the rating of perceived exertion (RPE) using a “target” workload on the monitor. RENEW will be increased very slowly over the first 3 weeks and, subsequently, to maintain an 11-13 perceived exertion. During the formal RENEW training regimen the participants become fully acclimated to the device (week 3-4) the total RENEW load will increase weekly with no increase in their RPE.
364844|NCT01080196|P2|Participant Flow|TRADITIONAL|The TRAD group will perform their lower extremity resistance exercise for 15 minutes per session with isotonic weight machines and cuff weights as part of their multicomponent exercise fall reduction program (MCERFP). The progression of the 3 x/week, 12 week TRAD program will be determined as a relative function of their 1 repetition maximum (1RM) weight that can be lifted in a safe and successful manner. The 1RM will be measured before the 12 week training program and every 2 weeks thereafter. A “target” resistance workload (i.e., weight level) commensurate with 60-70% of the 1RM of the knee and hip extensors will be calculated bi-monthly and 3 sets of 15 repetitions of 3-4 different knee and hip exercises will be used over a 15 minute time period.
364845|NCT01080196|P1|Participant Flow|RENEW|RENEW will occur on a recumbent ergometer that appears like a normal stepper ergometer. While resisting the foot pedal movement the participant experiences eccentric muscle contractions about the knee and hip while performing negative work. The progression of the 3 x/week (every other day), 12 week RENEW program will be determined as a function of the rating of perceived exertion (RPE) using a “target” workload on the monitor. RENEW will be increased very slowly over the first 3 weeks and, subsequently, to maintain an 11-13 perceived exertion. During the formal RENEW training regimen the participants become fully acclimated to the device (week 3-4) the total RENEW load will increase weekly with no increase in their RPE.
364961|NCT01079988|P1|Participant Flow|Cyclosporin|Starting dose 4.0 – 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
364846|NCT01080196|O2|Outcome|TRADITIONAL|The TRAD group will perform their lower extremity resistance exercise for 15 minutes per session with isotonic weight machines and cuff weights as part of their MCERFP. The progression of the 3 x/week, 12 week TRAD program will be determined as a relative function of their 1 repetition maximum (RM) weight that can be lifted in a safe and successful manner. The 1RM will be measured before the 12 week training program and every 2 weeks thereafter. A “target” resistance workload (i.e., weight level) commensurate with 60-70% of the 1RM of the knee and hip extensors will be calculated bi-monthly and 3 sets of 15 repetitions of 3-4 different knee and hip exercises will be used over a 15 minute time period.
364847|NCT01080196|O1|Outcome|RENEW|RENEW will occur on a recumbent ergometer that appears like a normal stepper ergometer. While resisting the foot pedal movement the participant experiences eccentric muscle contractions about the knee and hip while performing negative work. The progression of the 3 x/week (every other day), 12 week RENEW program will be determined as a function of the rating of perceived exertion (RPE) using a “target” workload on the monitor. RENEW will be increased very slowly over the first 3 weeks and, subsequently, to maintain an 11-13 perceived exertion. During the formal RENEW training regimen the participants become fully acclimated to the device (week 3-4) the total RENEW load will increase weekly with no increase in their RPE.
364848|NCT01080196|O2|Outcome|TRADITIONAL|The TRAD group will perform their lower extremity resistance exercise for 15 minutes per session with isotonic weight machines and cuff weights as part of their MCERFP. The progression of the 3 x/week, 12 week TRAD program will be determined as a relative function of their 1 repetition maximum (RM) weight that can be lifted in a safe and successful manner. The 1RM will be measured before the 12 week training program and every 2 weeks thereafter. A “target” resistance workload (i.e., weight level) commensurate with 60-70% of the 1RM of the knee and hip extensors will be calculated bi-monthly and 3 sets of 15 repetitions of 3-4 different knee and hip exercises will be used over a 15 minute time period.
364849|NCT01080196|O1|Outcome|RENEW|RENEW will occur on a recumbent ergometer that appears like a normal stepper ergometer. While resisting the foot pedal movement the participant experiences eccentric muscle contractions about the knee and hip while performing negative work. The progression of the 3 x/week (every other day), 12 week RENEW program will be determined as a function of the rating of perceived exertion (RPE) using a “target” workload on the monitor. RENEW will be increased very slowly over the first 3 weeks and, subsequently, to maintain an 11-13 perceived exertion. During the formal RENEW training regimen the participants become fully acclimated to the device (week 3-4) the total RENEW load will increase weekly with no increase in their RPE.
364850|NCT01080196|O2|Outcome|TRADITIONAL|The TRAD group will perform their lower extremity resistance exercise for 15 minutes per session with isotonic weight machines and cuff weights as part of their MCERFP. The progression of the 3 x/week, 12 week TRAD program will be determined as a relative function of their 1 repetition maximum (RM) weight that can be lifted in a safe and successful manner. The 1RM will be measured before the 12 week training program and every 2 weeks thereafter. A “target” resistance workload (i.e., weight level) commensurate with 60-70% of the 1RM of the knee and hip extensors will be calculated bi-monthly and 3 sets of 15 repetitions of 3-4 different knee and hip exercises will be used over a 15 minute time period.
364851|NCT01080196|O1|Outcome|RENEW|RENEW will occur on a recumbent ergometer that appears like a normal stepper ergometer. While resisting the foot pedal movement the participant experiences eccentric muscle contractions about the knee and hip while performing negative work. The progression of the 3 x/week (every other day), 12 week RENEW program will be determined as a function of the rating of perceived exertion (RPE) using a “target” workload on the monitor. RENEW will be increased very slowly over the first 3 weeks and, subsequently, to maintain an 11-13 perceived exertion. During the formal RENEW training regimen the participants become fully acclimated to the device (week 3-4) the total RENEW load will increase weekly with no increase in their RPE.
364852|NCT01080196|O2|Outcome|TRADITIONAL|The Traditional (TRAD) group will perform their lower extremity resistance exercise for 15 minutes per session with isotonic weight machines and cuff weights as part of their MCERFP. The progression of the 3 x/week, 12 week TRAD program will be determined as a relative function of their 1 repetition maximum (RM) weight that can be lifted in a safe and successful manner. The 1RM will be measured before the 12 week training program and every 2 weeks thereafter. A “target” resistance workload (i.e., weight level) commensurate with 60-70% of the 1RM of the knee and hip extensors will be calculated bi-monthly and 3 sets of 15 repetitions of 3-4 different knee and hip exercises will be used over a 15 minute time period.
364853|NCT01080196|O1|Outcome|RENEW|Resistance Exercise via Negative Work (RENEW) will occur on a recumbent ergometer that appears like a normal stepper ergometer. While resisting the foot pedal movement the participant experiences eccentric muscle contractions about the knee and hip while performing negative work. The progression of the 3 x/week (every other day), 12 week RENEW program will be determined as a function of the rating of perceived exertion (RPE) using a “target” workload on the monitor. RENEW will be increased very slowly over the first 3 weeks and, subsequently, to maintain an 11-13 perceived exertion. During the formal RENEW training regimen the participants become fully acclimated to the device (week 3-4) the total RENEW load will increase weekly with no increase in their RPE.
364854|NCT01080196|O2|Outcome|TRADITIONAL|The TRAD group will perform their lower extremity resistance exercise for 15 minutes per session with isotonic weight machines and cuff weights as part of their MCERFP. The progression of the 3 x/week, 12 week TRAD program will be determined as a relative function of their 1 repetition maximum (RM) weight that can be lifted in a safe and successful manner. The 1RM will be measured before the 12 week training program and every 2 weeks thereafter. A “target” resistance workload (i.e., weight level) commensurate with 60-70% of the 1RM of the knee and hip extensors will be calculated bi-monthly and 3 sets of 15 repetitions of 3-4 different knee and hip exercises will be used over a 15 minute time period.
364855|NCT01080196|O1|Outcome|RENEW|RENEW will occur on a recumbent ergometer that appears like a normal stepper ergometer. While resisting the foot pedal movement the participant experiences eccentric muscle contractions about the knee and hip while performing negative work. The progression of the 3 x/week (every other day), 12 week RENEW program will be determined as a function of the rating of perceived exertion (RPE) using a “target” workload on the monitor. RENEW will be increased very slowly over the first 3 weeks and, subsequently, to maintain an 11-13 perceived exertion. During the formal RENEW training regimen the participants become fully acclimated to the device (week 3-4) the total RENEW load will increase weekly with no increase in their RPE.
365139|NCT01079390|B4|Baseline|Total|Total of all reporting groups
364856|NCT01080196|E2|Reported Event|TRADITIONAL|The TRAD group will perform their lower extremity resistance exercise for 15 minutes per session with isotonic weight machines and cuff weights as part of their MCERFP. The progression of the 3 x/week, 12 week TRAD program will be determined as a relative function of their 1 repetition maximum (RM) weight that can be lifted in a safe and successful manner. The 1RM will be measured before the 12 week training program and every 2 weeks thereafter. A “target” resistance workload (i.e., weight level) commensurate with 60-70% of the 1RM of the knee and hip extensors will be calculated bi-monthly and 3 sets of 15 repetitions of 3-4 different knee and hip exercises will be used over a 15 minute time period.
364857|NCT01080196|E1|Reported Event|RENEW|RENEW will occur on a recumbent ergometer that appears like a normal stepper ergometer. While resisting the foot pedal movement the participant experiences eccentric muscle contractions about the knee and hip while performing negative work. The progression of the 3 x/week (every other day), 12 week RENEW program will be determined as a function of the rating of perceived exertion (RPE) using a “target” workload on the monitor. RENEW will be increased very slowly over the first 3 weeks and, subsequently, to maintain an 11-13 perceived exertion. During the formal RENEW training regimen the participants become fully acclimated to the device (week 3-4) the total RENEW load will increase weekly with no increase in their RPE.
364858|NCT01080131|B3|Baseline|Total|Total of all reporting groups
364859|NCT01080131|B2|Baseline|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study."
364860|NCT01080131|B1|Baseline|Canakinumab 150 mg|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months."
364861|NCT01080131|P2|Participant Flow|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study."
364862|NCT01080131|P1|Participant Flow|Canakinumab 150 mg|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months."
364863|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
364864|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
364865|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
364866|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the Ccre study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
364867|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
364868|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
364869|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
364870|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
364871|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
370632|NCT01067976|O1|Outcome|CMRM vs UMRM|
364872|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
364873|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
364874|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
364875|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
364876|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
364877|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
364878|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
364879|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study."
364880|NCT01080131|O1|Outcome|Canakinumab 150 mg|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months."
364881|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study."
364882|NCT01080131|O1|Outcome|Canakinumab 150 mg|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months."
364883|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
364884|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
364885|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
364886|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
365196|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
364887|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
364888|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
364889|NCT01080131|O6|Outcome|Triam: After Switch to Canakinumab|Participants who were treated with triamcinolone acetonide during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred after the switch to canakinumab.
364890|NCT01080131|O5|Outcome|Triam: Before Switch to Canakinumab|Participants who were treated with triamcinolone acetonide (triam) during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred before the switch to canakinumab.
364891|NCT01080131|O4|Outcome|All Triamcinolone Acetonide|"Participants received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same study treatment another 12 weeks for any new gout flare.~Reported data include all adverse events that occurred during the core study and extension studies 1 and 2, before participants were switched to canakinumab."
364892|NCT01080131|O3|Outcome|Canakinumab: After Retreatment|Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population after re-treatment with canakinumab.
364893|NCT01080131|O2|Outcome|Canakinumab: Before Retreatment|Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population before re-treatment with canakinumab.
364894|NCT01080131|O1|Outcome|All Canakinumab|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study, participants completing the 12 week core study could continue to be treated on demand with the same study treatment for an additional 12 weeks for any new gout flare.~In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc upon new flare for 1 year, for a total duration of 18 months."
364895|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
364896|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
364897|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
364898|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
364899|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
364900|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
364995|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
370633|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
364901|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
364902|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
364903|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
364904|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
364905|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
364906|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
364907|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
364908|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
364909|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
364910|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
364911|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
364912|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
364913|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
364931|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
364914|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
364915|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
364916|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
364917|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
364918|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
364919|NCT01080131|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
364920|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
364921|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
364922|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
364923|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
364924|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
364925|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
364926|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
364927|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
364928|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
364929|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
364930|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
364960|NCT01079988|P2|Participant Flow|Retinoids|Starting dose 25 – 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
365197|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
364932|NCT01080131|E6|Reported Event|Triam: After Switch to Canakinumab|Participants who were treated with triamcinolone acetonide during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred after the switch to canakinumab.
364933|NCT01080131|E5|Reported Event|Triam: Before Switch to Canakinumab|Participants who were treated with triamcinolone acetonide (triam) during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred before the switch to canakinumab.
364934|NCT01080131|E4|Reported Event|All Triamcinolone Acetonide|"Participants received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same study treatment another 12 weeks for any new gout flare.~Reported data include all adverse events that occurred during the core study and extension studies 1 and 2, before participants were switched to canakinumab."
364935|NCT01080131|E3|Reported Event|Canakinumab: After Retreatment|Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population after re-treatment with canakinumab.
364936|NCT01080131|E2|Reported Event|Canakinumab: Before Retreatment|Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population before re-treatment with canakinumab.
364937|NCT01080131|E1|Reported Event|All Canakinumab|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study, participants completing the 12 week core study could continue to be treated on demand with the same study treatment for an additional 12 weeks for any new gout flare.~In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc upon new flare for 1 year, for a total duration of 18 months."
364938|NCT01080118|B3|Baseline|Total|Total of all reporting groups
364939|NCT01080118|B2|Baseline|Video Laryngoscope Group|Medical students or interns attempting intubation with Airtraq video laryngoscope
364940|NCT01080118|B1|Baseline|Rigid Laryngoscope Group|Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
364941|NCT01080118|P4|Participant Flow|Video Laryngoscope Patients|Patients who were intubated using the video laryngoscope by interns or medical student.
364942|NCT01080118|P3|Participant Flow|Rigid Laryngoscope Patients|Patients who were intubated using the rigid laryngoscope by the medical student of intern.
364943|NCT01080118|P2|Participant Flow|Video Laryngoscope Group|Medical students or interns attempting intubation with Airtraq video laryngoscope
364944|NCT01080118|P1|Participant Flow|Rigid Laryngoscope Group|Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
364945|NCT01080118|O2|Outcome|Video Laryngoscope Group|Medical students or interns attempting intubation with Airtraq video laryngoscope
364946|NCT01080118|O1|Outcome|Rigid Laryngoscope Group|Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
364947|NCT01080118|O2|Outcome|Video Laryngoscope Group|Medical students or interns attempting intubation with Airtraq video laryngoscope
364948|NCT01080118|O1|Outcome|Rigid Laryngoscope Group|Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
364949|NCT01080118|E2|Reported Event|Video Laryngoscope Group|Medical students or interns attempting intubation with Airtraq video laryngoscope
364950|NCT01080118|E1|Reported Event|Rigid Laryngoscope Group|Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
364951|NCT01079988|B6|Baseline|Total|Total of all reporting groups
364952|NCT01079988|B5|Baseline|Systemic Corticosteroids/Methotrexate|"Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%.~Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks."
364953|NCT01079988|B4|Baseline|Methotrexate|Starting dose 20 – 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
364954|NCT01079988|B3|Baseline|Systemic Corticosteroids|Starting dose 0.25 – 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
364955|NCT01079988|B2|Baseline|Retinoids|Starting dose 25 – 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
364956|NCT01079988|B1|Baseline|Cyclosporin|Starting dose 4.0 – 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
364957|NCT01079988|P5|Participant Flow|Systemic Corticosteroids/Methotrexate|"Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%.~Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks."
364958|NCT01079988|P4|Participant Flow|Methotrexate|Starting dose 20 – 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
364959|NCT01079988|P3|Participant Flow|Systemic Corticosteroids|Starting dose 0.25 – 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
365198|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
364962|NCT01079988|O5|Outcome|Systemic Corticosteroids/Methotrexate|"Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%.~Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks."
364963|NCT01079988|O4|Outcome|Methotrexate|Starting dose 20 – 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
364964|NCT01079988|O3|Outcome|Systemic Corticosteroids|Starting dose 0.25 – 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
364965|NCT01079988|O2|Outcome|Retinoids|Starting dose 25 – 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
364966|NCT01079988|O1|Outcome|Cyclosporin|Starting dose 4.0 – 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
364967|NCT01079988|O5|Outcome|Systemic Corticosteroids/Methotrexate|"Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%.~Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks."
364968|NCT01079988|O4|Outcome|Methotrexate|Starting dose 20 – 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
364969|NCT01079988|O3|Outcome|Systemic Corticosteroids|Starting dose 0.25 – 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
364970|NCT01079988|O2|Outcome|Retinoids|Starting dose 25 – 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
364971|NCT01079988|O1|Outcome|Cyclosporin|Starting dose 4.0 – 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
364972|NCT01079988|E5|Reported Event|Systemic Corticosteroids/Methotrexate|"Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%.~Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks."
364973|NCT01079988|E4|Reported Event|Methotrexate|Starting dose 20 – 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
364974|NCT01079988|E3|Reported Event|Systemic Corticosteroids|Starting dose 0.25 – 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
364975|NCT01079988|E2|Reported Event|Retinoids|Starting dose 25 – 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
364976|NCT01079988|E1|Reported Event|Cyclosporin|Starting dose 4.0 – 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
364977|NCT01079962|B3|Baseline|Total|Total of all reporting groups
364978|NCT01079962|B2|Baseline|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
364979|NCT01079962|B1|Baseline|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
364980|NCT01079962|P2|Participant Flow|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
364981|NCT01079962|P1|Participant Flow|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
364982|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
364983|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
364984|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
364985|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
364986|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
364987|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
364988|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
364989|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
364990|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
364991|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
364992|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
364993|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
364994|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
365199|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
364996|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
364997|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
364998|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
364999|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
365000|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
365001|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
365002|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
365003|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
365004|NCT01079962|E2|Reported Event|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
365005|NCT01079962|E1|Reported Event|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
365006|NCT01079949|B3|Baseline|Total|Total of all reporting groups
365007|NCT01079949|B2|Baseline|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365008|NCT01079949|B1|Baseline|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365009|NCT01079949|P2|Participant Flow|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365010|NCT01079949|P1|Participant Flow|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365011|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365012|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365013|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365054|NCT01079936|B2|Baseline|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
365014|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365015|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365016|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365017|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365018|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365019|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365020|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365021|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365022|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365055|NCT01079936|B1|Baseline|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
365200|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
365023|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365024|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365025|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365026|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365027|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365028|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365029|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365030|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365031|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365041|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365032|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365033|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365034|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365035|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365036|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365037|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365038|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365039|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365040|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365053|NCT01079936|B3|Baseline|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
365201|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
365042|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365043|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365044|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365045|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365046|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365047|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365048|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365049|NCT01079949|E2|Reported Event|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365050|NCT01079949|E1|Reported Event|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
365051|NCT01079936|B5|Baseline|Total|Total of all reporting groups
365052|NCT01079936|B4|Baseline|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
365056|NCT01079936|P5|Participant Flow|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
365057|NCT01079936|P4|Participant Flow|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
365058|NCT01079936|P3|Participant Flow|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
365059|NCT01079936|P2|Participant Flow|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
365060|NCT01079936|P1|Participant Flow|Phase I: Lenalidomide + High-Dose Melphalan|Lenalidomide beginning dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
365061|NCT01079936|O4|Outcome|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
365062|NCT01079936|O3|Outcome|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
365063|NCT01079936|O2|Outcome|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
365064|NCT01079936|O1|Outcome|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
365065|NCT01079936|O4|Outcome|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
365066|NCT01079936|O3|Outcome|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
365067|NCT01079936|O2|Outcome|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
365068|NCT01079936|O1|Outcome|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
365069|NCT01079936|O4|Outcome|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
365070|NCT01079936|O3|Outcome|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
365071|NCT01079936|O2|Outcome|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
365072|NCT01079936|O1|Outcome|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
365073|NCT01079936|O1|Outcome|Lenalidomide + High-Dose Melphalan|"Lenalidomide beginning dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.~Lenalidomide: Beginning dose level 25 mg by mouth (PO) on Days -8 to -2~Melphalan: Dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion~Stem Cell Infusion: Stem cell infusion on Day 0."
365074|NCT01079936|E4|Reported Event|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
365075|NCT01079936|E3|Reported Event|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
365076|NCT01079936|E2|Reported Event|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
365077|NCT01079936|E1|Reported Event|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
365078|NCT01079832|B1|Baseline|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
365079|NCT01079832|P1|Participant Flow|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
365080|NCT01079832|O1|Outcome|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
365081|NCT01079832|O1|Outcome|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
365082|NCT01079832|O1|Outcome|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
365083|NCT01079832|O1|Outcome|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
365084|NCT01079832|O1|Outcome|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
365085|NCT01079832|E1|Reported Event|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
365086|NCT01079806|B3|Baseline|Total|Total of all reporting groups
365087|NCT01079806|B2|Baseline|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
365088|NCT01079806|B1|Baseline|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
365089|NCT01079806|P2|Participant Flow|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
365090|NCT01079806|P1|Participant Flow|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
365091|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
365092|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
365093|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
365094|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
365095|NCT01079806|O2|Outcome|Placebo|Placebo: Tablets/Oral Solution, Oral, 0 mg, once daily, 48-96 weeks, depending on response
365096|NCT01079806|O1|Outcome|Entecavir|Entecavir: Tablets/Oral Solution, Oral, 0.015 mg/kg up to 0.5 mg, once daily, 96-144 weeks, depending on response
365097|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
365098|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
365099|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
365100|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
365101|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
365102|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
365103|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
365104|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
365105|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
365106|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
365107|NCT01079806|E2|Reported Event|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
365108|NCT01079806|E1|Reported Event|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
365109|NCT01079741|B6|Baseline|Total|Total of all reporting groups
365110|NCT01079741|B5|Baseline|NY-ESO-1 Protein, Poly-ICLC and Montanide|100μg NY-ESO-1 protein, 1.4mg Poly-ICLC and 1.1mL Montanide.
365111|NCT01079741|B4|Baseline|NY-ESO-1 Protein and Poly-ICLC|100μg NY-ESO-1 protein, 1.4mg Poly-ICLC.
365112|NCT01079741|B3|Baseline|Poly-ICLC 1.4mg|100 µg NY-ESO-1 protein + 1.1 mL Montanide + 1.4 mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
365113|NCT01079741|B2|Baseline|Poly-ICLC 0.70 mg|100 µg NY-ESO-1 protein + 1.1 mL Montanide + 0.7mg Poly-ICLC.The cycle was repeated every 3 weeks for a total of 4 cycles.
365114|NCT01079741|B1|Baseline|Poly-ICLC 0.35 mg|Cohort 1 100µg NY-ESO-1 protein + 1.1 mL Montanide + 0.35mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
365115|NCT01079741|P5|Participant Flow|NY-ESO-1 Protein, Poly-ICLC and Montanide|Phase 2, Arm 2 100μg NY-ESO-1 protein, 1.4mg Poly-ICLC and 1.1mL Montanide.
365116|NCT01079741|P4|Participant Flow|NY-ESO-1 Protein and Poly-ICLC|Phase 2, Arm 1 100μg NY-ESO-1 protein, 1.4mg Poly-ICLC.
365117|NCT01079741|P3|Participant Flow|Poly-ICLC 1.4mg|Cohort 3 100 µg NY-ESO-1 protein + 1.1 mL Montanide + 1.4 mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
365118|NCT01079741|P2|Participant Flow|Poly-ICLC 0.7mg|Cohort 2 100 µg NY-ESO-1 protein + 1.1 mL Montanide + 0.7mg Poly-ICLC.The cycle was repeated every 3 weeks for a total of 4 cycles.
365119|NCT01079741|P1|Participant Flow|Poly-ICLC 0.35mg|Cohort 1 100µg NY-ESO-1 protein + 1.1 mL Montanide + 0.35mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
365120|NCT01079741|O2|Outcome|NY-ESO-1 Protein, Poly-ICLC and Montanide|100μg NY-ESO-1 protein, 1.4mg Poly-ICLC and 1.1mL Montanide.
365121|NCT01079741|O1|Outcome|NY-ESO-1 Protein and Poly-ICLC|100μg NY-ESO-1 protein, 1.4mg Poly-ICLC.
365122|NCT01079741|O2|Outcome|NY-ESO-1 Protein, Poly-ICLC and Montanide|100μg NY-ESO-1 protein, 1.4mg Poly-ICLC and 1.1mL Montanide.
365123|NCT01079741|O1|Outcome|NY-ESO-1 Protein and Poly-ICLC|100μg NY-ESO-1 protein, 1.4mg Poly-ICLC.
365124|NCT01079741|O3|Outcome|Poly-ICLC 1.4mg|100 µg NY-ESO-1 protein + 1.1 mL Montanide + 1.4 mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
365125|NCT01079741|O2|Outcome|Poly-ICLC 0.70 mg|100 µg NY-ESO-1 protein + 1.1 mL Montanide + 0.7mg Poly-ICLC.The cycle was repeated every 3 weeks for a total of 4 cycles.
365126|NCT01079741|O1|Outcome|Poly-ICLC 0.35 mg|Cohort 1 100µg NY-ESO-1 protein + 1.1 mL Montanide + 0.35mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
365127|NCT01079741|E5|Reported Event|Phase 2, Arm 2|100μg NY-ESO-1 protein, 1.4mg Poly-ICLC and 1.1mL Montanide.
365128|NCT01079741|E4|Reported Event|Phase 2, Arm 1|100μg NY-ESO-1 protein, 1.4mg Poly-ICLC.
365129|NCT01079741|E3|Reported Event|Poly-ICLC 1.4mg|100 µg NY-ESO-1 protein + 1.1 mL Montanide + 1.4 mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
365130|NCT01079741|E2|Reported Event|Poly-ICLC 0.70 mg|100 µg NY-ESO-1 protein + 1.1 mL Montanide + 0.7mg Poly-ICLC.The cycle was repeated every 3 weeks for a total of 4 cycles.
365131|NCT01079741|E1|Reported Event|Poly-ICLC 0.35 mg|Cohort 1 100µg NY-ESO-1 protein + 1.1 mL Montanide + 0.35mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
365132|NCT01079598|B1|Baseline|Treatment|RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
365133|NCT01079598|P1|Participant Flow|Treatment|RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
365134|NCT01079598|O1|Outcome|Treatment|RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
365135|NCT01079598|O1|Outcome|Treatment|RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
365136|NCT01079598|O1|Outcome|Treatment|RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
365140|NCT01079390|B3|Baseline|Placebo Acupuncture|"sham acupuncture treatment will be applied~acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
365141|NCT01079390|B2|Baseline|Low Dose Acupuncture|"two needles will be applied.~acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
365142|NCT01079390|B1|Baseline|High Dose Acupuncture|"six needle applied during acupuncture~acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
365143|NCT01079390|P3|Participant Flow|Placebo Acupuncture|"sham acupuncture treatment will be applied~acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
365144|NCT01079390|P2|Participant Flow|Low Dose Acupuncture|"two needles will be applied.~acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
365145|NCT01079390|P1|Participant Flow|High Dose Acupuncture|"six needle applied during acupuncture~acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
365146|NCT01079390|O2|Outcome|Placebo Acupuncture|"sham acupuncture treatment will be applied~acupuncture : patient will receive sham acupuncture treatment."
365147|NCT01079390|O1|Outcome|Acupuncture|"six needle applied during acupuncture~acupuncture : patient will receive high or low dose."
365148|NCT01079390|O3|Outcome|Placebo Acupuncture|"sham acupuncture treatment will be applied~acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
365149|NCT01079390|O2|Outcome|Low Dose Acupuncture|"two needles will be applied.~acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
365150|NCT01079390|O1|Outcome|High Dose Acupuncture|"six needle applied during acupuncture~acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
365151|NCT01079390|E3|Reported Event|Placebo Acupuncture|"sham acupuncture treatment will be applied~acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
365152|NCT01079390|E2|Reported Event|Low Dose Acupuncture|"two needles will be applied.~acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
365153|NCT01079390|E1|Reported Event|High Dose Acupuncture|"six needle applied during acupuncture~acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
365154|NCT01079299|B3|Baseline|Total|Total of all reporting groups
365155|NCT01079299|B2|Baseline|Standard Compression Alone|
365156|NCT01079299|B1|Baseline|IPC Plus Standard Compression|
365157|NCT01079299|P2|Participant Flow|Standard Compression Alone|
365158|NCT01079299|P1|Participant Flow|IPC Plus Standard Compression|
365159|NCT01079299|O2|Outcome|Standard Compression Alone|
365160|NCT01079299|O1|Outcome|IPC Plus Standard Compression|
365161|NCT01079299|E2|Reported Event|Standard Compression Alone|
365162|NCT01079299|E1|Reported Event|IPC Plus Standard Compression|
365163|NCT01079234|B4|Baseline|Total|Total of all reporting groups
365164|NCT01079234|B3|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
365165|NCT01079234|B2|Baseline|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with the evening meal in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
365166|NCT01079234|B1|Baseline|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
365167|NCT01079234|P4|Participant Flow|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
365168|NCT01079234|P3|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
365169|NCT01079234|P2|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with the evening meal in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
365170|NCT01079234|P1|Participant Flow|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
365171|NCT01079234|O2|Outcome|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
365172|NCT01079234|O1|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
365173|NCT01079234|O2|Outcome|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
365174|NCT01079234|O1|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
365175|NCT01079234|O2|Outcome|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
365176|NCT01079234|O1|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
365177|NCT01079234|O3|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
365178|NCT01079234|O2|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with the evening meal in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
365179|NCT01079234|O1|Outcome|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
365180|NCT01079234|O2|Outcome|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
365181|NCT01079234|O1|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
365182|NCT01079234|O3|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
365183|NCT01079234|O2|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with the evening meal in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
365184|NCT01079234|O1|Outcome|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
365185|NCT01079234|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
365186|NCT01079234|E1|Reported Event|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
365187|NCT01079195|B1|Baseline|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
365188|NCT01079195|P1|Participant Flow|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
365189|NCT01079195|O1|Outcome|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
365190|NCT01079195|O1|Outcome|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
365191|NCT01079195|O1|Outcome|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
365192|NCT01079195|E1|Reported Event|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
365193|NCT01079182|B1|Baseline|Ankylosing Spondylitis|Participants with ankylosing spondylitis
365194|NCT01079182|P1|Participant Flow|Ankylosing Spondylitis|Participants with ankylosing spondylitis
365195|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
365211|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
365212|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
365213|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
365214|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
365215|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
365216|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
365217|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
365218|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
365219|NCT01079182|E1|Reported Event|Ankylosing Spondylitis|Participants with ankylosing spondylitis
365220|NCT01079143|B5|Baseline|Total|Total of all reporting groups
365221|NCT01079143|B4|Baseline|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365222|NCT01079143|B3|Baseline|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365223|NCT01079143|B2|Baseline|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365224|NCT01079143|B1|Baseline|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365225|NCT01079143|P4|Participant Flow|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365226|NCT01079143|P3|Participant Flow|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365227|NCT01079143|P2|Participant Flow|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365228|NCT01079143|P1|Participant Flow|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365229|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365230|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365231|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365232|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365233|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365234|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365235|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365236|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365237|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365238|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365239|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365240|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365241|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365242|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365269|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365243|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365244|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365245|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365246|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365247|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365248|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365249|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365250|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365251|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365252|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365253|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365254|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365255|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365256|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365257|NCT01079143|O2|Outcome|Neoral|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365258|NCT01079143|O1|Outcome|Certican|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365259|NCT01079143|O2|Outcome|Neoral|Between transplantation adn randomization, all patients have received Neoral. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic.
365260|NCT01079143|O1|Outcome|Certican|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365261|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365262|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365263|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365264|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365265|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365266|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365267|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365268|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365370|NCT01078844|O1|Outcome|Placebo|"Treatment as usual plus placebo~Placebo: Look-alike placebo"
365270|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365271|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365272|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365273|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365274|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365275|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365276|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365277|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365278|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365279|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365280|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365281|NCT01079143|O2|Outcome|No- No Fibrosis Progression|Participants who did not experience fibrosis progression based on IF/TA (univariate analysis)
365282|NCT01079143|O1|Outcome|Yes- Fibrosis Progression|Participants who experienced fibrosis progression based on IF/TA (univariate analysis)
365283|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365284|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365285|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365286|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365287|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365288|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365289|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365290|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365291|NCT01079143|O2|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365292|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365293|NCT01079143|E2|Reported Event|Certican|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
365294|NCT01079143|E1|Reported Event|Neoral|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
365295|NCT01079130|B7|Baseline|Total|Total of all reporting groups
365296|NCT01079130|B6|Baseline|Placebo|Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
365371|NCT01078844|E1|Reported Event|All Participants|"Treatment as usual plus memantine~memantine: memantine 5-20 mg daily~OR~Treatment as usual plus Placebo"
365297|NCT01079130|B5|Baseline|Salmeterol|Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
365298|NCT01079130|B4|Baseline|Indacaterol 150 µg|Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
365299|NCT01079130|B3|Baseline|Indacaterol 75 µg|Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
365300|NCT01079130|B2|Baseline|Indacaterol 37.5 µg|Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
365301|NCT01079130|B1|Baseline|Indacaterol 18.75 µg|Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
365302|NCT01079130|P6|Participant Flow|Placebo|Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
365303|NCT01079130|P5|Participant Flow|Salmeterol|Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
365304|NCT01079130|P4|Participant Flow|Indacaterol 150 µg|Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
365305|NCT01079130|P3|Participant Flow|Indacaterol 75 µg|Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
365306|NCT01079130|P2|Participant Flow|Indacaterol 37.5 µg|Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
365307|NCT01079130|P1|Participant Flow|Indacaterol 18.75 µg|Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
365308|NCT01079130|O6|Outcome|Placebo|Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
365309|NCT01079130|O5|Outcome|Salmeterol|Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
365310|NCT01079130|O4|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
365311|NCT01079130|O3|Outcome|Indacaterol 75 µg|Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
365312|NCT01079130|O2|Outcome|Indacaterol 37.5 µg|Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
365313|NCT01079130|O1|Outcome|Indacaterol 18.75 µg|Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
365372|NCT01078805|B1|Baseline|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
365314|NCT01079130|O6|Outcome|Placebo|Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
365315|NCT01079130|O5|Outcome|Salmeterol|Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
365316|NCT01079130|O4|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
365317|NCT01079130|O3|Outcome|Indacaterol 75 µg|Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
365318|NCT01079130|O2|Outcome|Indacaterol 37.5 µg|Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
365319|NCT01079130|O1|Outcome|Indacaterol 18.75 µg|Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
365320|NCT01079130|E6|Reported Event|Placebo|Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
365321|NCT01079130|E5|Reported Event|Salmeterol|Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
365322|NCT01079130|E4|Reported Event|Indacaterol 150 µg|Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
365323|NCT01079130|E3|Reported Event|Indacaterol 75 µg|Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
365324|NCT01079130|E2|Reported Event|Indacaterol 37.5 µg|Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
365325|NCT01079130|E1|Reported Event|Indacaterol 18.75 µg|Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
365326|NCT01078974|B1|Baseline|Pomalidomide, Dexamethasone, Rituximab|"Drug: pomalidomide Taken orally once a day~Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~pomalidomide: Taken orally once a day~dexamethasone: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~rituximab: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15"
365327|NCT01078974|P1|Participant Flow|Pomalidomide, Dexamethasone, Rituximab|"Drug: pomalidomide Taken orally once a day~Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~pomalidomide: Taken orally once a day~dexamethasone: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~rituximab: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15"
365328|NCT01078974|O1|Outcome|Pomalidomide, Dexamethasone, Rituximab|"Drug: pomalidomide Taken orally once a day~Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~pomalidomide: Taken orally once a day~dexamethasone: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~rituximab: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15"
365329|NCT01078974|O1|Outcome|Pomalidomide, Dexamethasone, Rituximab|"Drug: pomalidomide Taken orally once a day~Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~pomalidomide: Taken orally once a day~dexamethasone: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~rituximab: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15"
365373|NCT01078805|P1|Participant Flow|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
365374|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
365330|NCT01078974|E1|Reported Event|Pomalidomide, Dexamethasone, Rituximab|"Drug: pomalidomide Taken orally once a day~Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~pomalidomide: Taken orally once a day~dexamethasone: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~rituximab: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15"
365331|NCT01078922|B1|Baseline|Ofatumumab|The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
365332|NCT01078922|P1|Participant Flow|Ofatumumab|Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
365333|NCT01078922|O1|Outcome|Ofatumumab|"The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.~Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours."
365334|NCT01078922|O1|Outcome|Ofatumumab|Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
365335|NCT01078922|E1|Reported Event|Ofatumumab|"The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.~Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours."
365336|NCT01078909|B6|Baseline|Total|Total of all reporting groups
365337|NCT01078909|B5|Baseline|Placebo|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 5 month supplementation period
365338|NCT01078909|B4|Baseline|1800mg Fish Oil (EPA + DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 5 month supplementation period
365339|NCT01078909|B3|Baseline|900mg Fish Oil (EPA + DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 65 month supplementation period
365340|NCT01078909|B2|Baseline|600mg Fish Oil (EPA+DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 5 month supplementation period
365341|NCT01078909|B1|Baseline|300mg Fish Oil (EPA + DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 5 month supplementation period
365342|NCT01078909|P5|Participant Flow|Placebo|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period
365343|NCT01078909|P4|Participant Flow|1800mg Fish Oil (EPA + DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period
365344|NCT01078909|P3|Participant Flow|900mg Fish Oil (EPA + DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period
365345|NCT01078909|P2|Participant Flow|600mg Fish Oil (EPA+DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period
365346|NCT01078909|P1|Participant Flow|300mg Fish Oil (EPA + DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period
365347|NCT01078909|O5|Outcome|Placebo|
365348|NCT01078909|O4|Outcome|1800mg Fish Oil (EPA + DHA) Supplement|
365349|NCT01078909|O3|Outcome|900mg Fish Oil (EPA + DHA) Supplement|
365350|NCT01078909|O2|Outcome|600mg Fish Oil (EPA+DHA) Supplement|
365351|NCT01078909|O1|Outcome|300mg Fish Oil (EPA + DHA) Supplement|
365352|NCT01078909|O5|Outcome|Placebo|
365353|NCT01078909|O4|Outcome|1800mg Fish Oil (EPA + DHA) Supplement|
365354|NCT01078909|O3|Outcome|900mg Fish Oil (EPA + DHA) Supplement|
365355|NCT01078909|O2|Outcome|600mg Fish Oil (EPA+DHA) Supplement|
365356|NCT01078909|O1|Outcome|300mg Fish Oil (EPA + DHA) Supplement|
365357|NCT01078909|O5|Outcome|Placebo|
365358|NCT01078909|O4|Outcome|1800mg Fish Oil (EPA + DHA) Supplement|
365359|NCT01078909|O3|Outcome|900mg Fish Oil (EPA + DHA) Supplement|
365360|NCT01078909|O2|Outcome|600mg Fish Oil (EPA+DHA) Supplement|
365361|NCT01078909|O1|Outcome|300mg Fish Oil (EPA + DHA) Supplement|
365362|NCT01078909|E5|Reported Event|0 mg/d EPA + DHA (Placebo)|
365363|NCT01078909|E4|Reported Event|1800 mg/d EPA + DHA (Fish Oil) Supplement|
365364|NCT01078909|E3|Reported Event|900 mg/d EPA + DHA (Fish Oil) Supplement|
365365|NCT01078909|E2|Reported Event|600 mg/d EPA + DHA (Fish Oil) Supplement|
365366|NCT01078909|E1|Reported Event|300 mg/d EPA + DHA (Fish Oil) Supplement|
365367|NCT01078844|B1|Baseline|All Participants|"Treatment as usual plus memantine~memantine: memantine 5-20 mg daily~OR~Treatment as usual plus Placebo"
365368|NCT01078844|P1|Participant Flow|All Participants|"Treatment as usual plus memantine~memantine: memantine 5-20 mg daily~OR~Treatment as usual plus Placebo"
365369|NCT01078844|O2|Outcome|Memantine|"Treatment as usual plus memantine~memantine: memantine 5-20 mg daily"
365375|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
365376|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
365377|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
365378|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
365379|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
365380|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
365381|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
365382|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
365383|NCT01078805|E1|Reported Event|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
365384|NCT01078753|B3|Baseline|Total|Total of all reporting groups
365385|NCT01078753|B2|Baseline|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
365386|NCT01078753|B1|Baseline|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
365387|NCT01078753|P2|Participant Flow|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
365388|NCT01078753|P1|Participant Flow|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
365389|NCT01078753|O2|Outcome|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
365390|NCT01078753|O1|Outcome|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
365391|NCT01078753|O2|Outcome|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
365392|NCT01078753|O1|Outcome|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
365393|NCT01078753|O2|Outcome|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
365394|NCT01078753|O1|Outcome|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
365395|NCT01078753|E2|Reported Event|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
365396|NCT01078753|E1|Reported Event|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
365397|NCT01078675|B3|Baseline|Total|Total of all reporting groups
365398|NCT01078675|B2|Baseline|Healthy Siblings|Controls to HeFH patients in the cIMT evaluations
365399|NCT01078675|B1|Baseline|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
365400|NCT01078675|P2|Participant Flow|Healthy Siblings|Controls to HeFH patients in the cIMT evaluations
365401|NCT01078675|P1|Participant Flow|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
365402|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
365403|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 10 mg
365405|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
365406|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
365407|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
365408|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
365409|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
365410|NCT01078675|O2|Outcome|Healthy Siblings|Controls to HeFH patients in the cIMT evaluations
365411|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
365412|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
365413|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 10 mg
365414|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
365415|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
365416|NCT01078675|E1|Reported Event|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
365417|NCT01078662|B6|Baseline|Total|Total of all reporting groups
365418|NCT01078662|B5|Baseline|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
365419|NCT01078662|B4|Baseline|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
365420|NCT01078662|B3|Baseline|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
365421|NCT01078662|B2|Baseline|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
365422|NCT01078662|B1|Baseline|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
365423|NCT01078662|P5|Participant Flow|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
365424|NCT01078662|P4|Participant Flow|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
365425|NCT01078662|P3|Participant Flow|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
365426|NCT01078662|P2|Participant Flow|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
365427|NCT01078662|P1|Participant Flow|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
365428|NCT01078662|O6|Outcome|All Patients|Patients of different cancer types
365429|NCT01078662|O5|Outcome|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
365430|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
365431|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
365432|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
365433|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
365434|NCT01078662|O6|Outcome|All Patients|Patients of different cancer types
365435|NCT01078662|O5|Outcome|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
365436|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
365437|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
365438|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
365439|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
365440|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
365441|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
365442|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
365443|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
365444|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
365445|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
365446|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
365447|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
365448|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
365449|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
365450|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
365451|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
365452|NCT01078662|O6|Outcome|All Patients|Patients of different cancer types
365453|NCT01078662|O5|Outcome|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
365454|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
365455|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
365456|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
365457|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
365458|NCT01078662|O6|Outcome|All Patients|Patients of different cancer types
365459|NCT01078662|O5|Outcome|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
365460|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
365461|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
365462|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
365463|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
365464|NCT01078662|E1|Reported Event|OLAPARIB|
365465|NCT01078623|B1|Baseline|Overall Study Population|All patients randomized into the study
365466|NCT01078623|P20|Participant Flow|Sequence 20|Placebo - Formoterol 12 - Aclidinium 200 - FDC 200/12
365467|NCT01078623|P19|Participant Flow|Sequence 19|Formoterol 12 - Aclidinium 200 - FDC 200/12 - FDC 200/6
365468|NCT01078623|P18|Participant Flow|Sequence 18|Aclidinium 200 - FDC 200/12 - FDC 200/6 - Placebo
365469|NCT01078623|P17|Participant Flow|Sequence 17|FDC 200/12 - FDC 200/6 - Placebo - Formoterol 12
365470|NCT01078623|P16|Participant Flow|Sequence 16|FDC 200/6 - Placebo - Formoterol 12 - Aclidinium 200
365471|NCT01078623|P15|Participant Flow|Sequence 15|Placebo - Aclidinium 200 - FDC 200/6 - Formoterol 12
365472|NCT01078623|P14|Participant Flow|Sequence 14|Formoterol 12 - FDC 200/12 - Placebo - Aclidinium 200
365473|NCT01078623|P13|Participant Flow|Sequence 13|Aclidinium 200 - FDC 200/6 - Formoterol 12 - FDC 200/12
365474|NCT01078623|P12|Participant Flow|Sequence 12|FDC 200/12 - Placebo - Aclidinium 200 - FDC 200/6
365475|NCT01078623|P11|Participant Flow|Sequence 11|FDC 200/6 - Formoterol 12 - FDC 200/12 - Placebo
365476|NCT01078623|P10|Participant Flow|Sequence 10|Placebo - FDC 200/12 - Formoterol 12 - FDC 200/6
365477|NCT01078623|P9|Participant Flow|Sequence 9|Formoterol 12 - FDC 200/6 - Aclidinium 200 - Placebo
365478|NCT01078623|P8|Participant Flow|Sequence 8|Aclidinium 200 - Placebo - FDC 200/12 - Formoterol 12
365479|NCT01078623|P7|Participant Flow|Sequence 7|FDC 200/12 - Formoterol 12 - FDC 200/6 - Aclidinium 200
365480|NCT01078623|P6|Participant Flow|Sequence 6|FDC 200/6 - Aclidinium 200 - Placebo - FDC 200/12
365481|NCT01078623|P5|Participant Flow|Sequence 5|Placebo - FDC 200/6 - FDC 200/12 - Aclidinium 200
365482|NCT01078623|P4|Participant Flow|Sequence 4|Formoterol 12 - Placebo - FDC 200/6 - FDC 200/12
365483|NCT01078623|P3|Participant Flow|Sequence 3|Aclidinium 200 - Formoterol 12 - Placebo - FDC 200/6
365484|NCT01078623|P2|Participant Flow|Sequence 2|FDC 200/12 - Aclidinium 200 - Formoterol 12 - Placebo
365485|NCT01078623|P1|Participant Flow|Sequence 1|FDC 200/6 μg - FDC 200/12 μg - Aclidinium 200 μg - Formoterol 12 μg
365486|NCT01078623|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg twice daily
365487|NCT01078623|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg twice daily
365488|NCT01078623|O3|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumurate 6 μg fixed dose combination (FDC) twice daily
365489|NCT01078623|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumurate 12 μg fixed dose combination (FDC) twice daily
365490|NCT01078623|O1|Outcome|Placebo|Placebo twice daily
365491|NCT01078623|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg twice daily
365492|NCT01078623|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg twice daily
365493|NCT01078623|O3|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumurate 6 μg fixed dose combination (FDC) twice daily
365494|NCT01078623|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumurate 12 μg fixed dose combination (FDC) twice daily
365495|NCT01078623|O1|Outcome|Placebo|Placebo twice daily
365496|NCT01078623|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg twice daily
365497|NCT01078623|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg twice daily
365498|NCT01078623|O3|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumurate 6 μg fixed dose combination (FDC) twice daily
365499|NCT01078623|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumurate 12 μg fixed dose combination (FDC) twice daily
365500|NCT01078623|O1|Outcome|Placebo|Placebo twice daily
365501|NCT01078623|E5|Reported Event|Formoterol 12 μg|Formoterol fumurate 12 μg twice daily
365502|NCT01078623|E4|Reported Event|Aclidinium 200 μg|Aclidinium bromide 200 μg twice daily
365503|NCT01078623|E3|Reported Event|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumurate 6 μg fixed dose combination (FDC) twice daily
365504|NCT01078623|E2|Reported Event|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumurate 12 μg fixed dose combination (FDC) twice daily
365505|NCT01078623|E1|Reported Event|Placebo|Placebo twice daily
365506|NCT01078584|B1|Baseline|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365507|NCT01078584|P1|Participant Flow|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365508|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365509|NCT01078584|O2|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
365510|NCT01078584|O1|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365635|NCT01078402|O4|Outcome|All Participants (RA, PsA, AS)|Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
365511|NCT01078584|O2|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
365512|NCT01078584|O1|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365513|NCT01078584|O2|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
365514|NCT01078584|O1|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365515|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365516|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365517|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365518|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365519|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365520|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365521|NCT01078584|O4|Outcome|Diabetic Cohort: BP-Controlled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg.
365522|NCT01078584|O3|Outcome|Diabetic Cohort: BP-Uncontrolled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg.
365523|NCT01078584|O2|Outcome|Non-Diabetic Cohort: BP-Controlled|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-controlled if BP <140/90 mm Hg.
365524|NCT01078584|O1|Outcome|Non-Diabetic Cohort: BP-Uncontrolled|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-uncontrolled if BP >/=140/90 mm Hg.
365525|NCT01078584|O4|Outcome|Diabetic Cohort: BP-Controlled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg.
365526|NCT01078584|O3|Outcome|Diabetic Cohort: BP-Uncontrolled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg.
365543|NCT01078584|O4|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
365527|NCT01078584|O2|Outcome|Non-Diabetic Cohort: BP-Controlled|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-controlled if BP <140/90 mm Hg.
365528|NCT01078584|O1|Outcome|Non-Diabetic Cohort: BP-Uncontrolled|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-uncontrolled if BP >/=140/90 mm Hg.
365529|NCT01078584|O4|Outcome|Diabetic Cohort: BP-Controlled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg.
365530|NCT01078584|O3|Outcome|Diabetic Cohort: BP-Uncontrolled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg.
365531|NCT01078584|O2|Outcome|Non-Diabetic Cohort: BP-Controlled|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-controlled if BP <140/90 mm Hg.
365532|NCT01078584|O1|Outcome|Non-Diabetic Cohort: BP-Uncontrolled|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-uncontrolled if BP >/=140/90 mm Hg.
365533|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365534|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365535|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365536|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365537|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365538|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365539|NCT01078584|O4|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
365540|NCT01078584|O3|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365541|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365542|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365604|NCT01078545|P1|Participant Flow|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
365544|NCT01078584|O3|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365545|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365546|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365547|NCT01078584|O4|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
365548|NCT01078584|O3|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365549|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365550|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365551|NCT01078584|O4|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
365552|NCT01078584|O3|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365553|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365554|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365555|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365556|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365557|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365558|NCT01078584|O1|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
365559|NCT01078584|O1|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
365560|NCT01078584|O1|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
365605|NCT01078545|O1|Outcome|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
365561|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365562|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365563|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365564|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365565|NCT01078584|O1|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365566|NCT01078584|O1|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365567|NCT01078584|O1|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365568|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365569|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365570|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365571|NCT01078584|O3|Outcome|Diabetic Cohort: BP-Uncontrolled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg.
365572|NCT01078584|O2|Outcome|Diabetic Cohort: BP-Controlled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg.
365573|NCT01078584|O1|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365574|NCT01078584|O3|Outcome|Diabetic Cohort: BP-Uncontrolled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg.
365575|NCT01078584|O2|Outcome|Diabetic Cohort: BP-Controlled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg.
365576|NCT01078584|O1|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365606|NCT01078545|O1|Outcome|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
365636|NCT01078402|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
365577|NCT01078584|O3|Outcome|Diabetic Cohort: BP-Uncontrolled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg.
365578|NCT01078584|O2|Outcome|Diabetic Cohort: BP-Controlled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg.
365579|NCT01078584|O1|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365580|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365581|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365582|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365583|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365584|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365585|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365586|NCT01078584|E1|Reported Event|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
365587|NCT01078571|B1|Baseline|Adalimumab (Humira)|
365588|NCT01078571|P1|Participant Flow|Adalimumab Treatment|Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks
365589|NCT01078571|O2|Outcome|Adalimumab (Treated for Greater Than 4 Months|Participants who had been taking adalimumab for 4 months or longer.
365590|NCT01078571|O1|Outcome|Adalimumab (De Novo)|"Those participants to whom adalimumab had been prescribed for the first time four months or less before the baseline visit were classified as de novo participants."
365591|NCT01078571|O2|Outcome|Adalimumab (Treatment for Greater Than 4 Months)|Participants who had been taking adalimumab for 4 months or longer.
365592|NCT01078571|O1|Outcome|Adalimumab (De Novo)|"Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as de novo participants."
365593|NCT01078571|O2|Outcome|Adalimumab (Treated for Greater Than 4 Months)|Participants who had been taking adalimumab for 4 months or longer.
365594|NCT01078571|O1|Outcome|Adalimumab (De Novo)|"Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as de novo participants."
365595|NCT01078571|O2|Outcome|Adalimumab (Treated for Greater Than 4 Months)|Participants who had been taking adalimumab for 4 months or longer.
365596|NCT01078571|O1|Outcome|Adalimumab (De Novo)|"Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as de novo participants."
365597|NCT01078571|O2|Outcome|Adalimumab (Treated for Greater Than 4 Months)|Participants who had been taking adalimumab for 4 months or longer.
365598|NCT01078571|O1|Outcome|Adalimumab (De Novo)|"Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as de novo participants."
365599|NCT01078571|O2|Outcome|Adalimumab (Treated for Greater Than 4 Months)|Participants who had been taking adalimumab for 4 months or longer.
365600|NCT01078571|O1|Outcome|Adalimumab (De Novo)|"Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as de novo participants."
365601|NCT01078571|O1|Outcome|Adalimumab Treatment|Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks
365602|NCT01078571|E1|Reported Event|Adalimumab Treatment|Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks
365603|NCT01078545|B1|Baseline|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
365634|NCT01078402|O1|Outcome|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
365607|NCT01078545|O1|Outcome|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
365608|NCT01078545|O1|Outcome|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
365609|NCT01078545|O1|Outcome|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
365610|NCT01078545|E1|Reported Event|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
365611|NCT01078454|B3|Baseline|Total|Total of all reporting groups
365612|NCT01078454|B2|Baseline|Arm B (B-Mel-Dex)|Patients receive melphalan 0.22 mg/kg PO and dexamethasone 40 mg PO on days 1-4 and bortezomib 1.3 mg/m^2 intravenously (IV) on days 1, 4, 8, and 11 every 4 weeks. Treatment repeats every 4 weeks for 2 cycles. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22 every 5 weeks. Treatment repeats every 5 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
365613|NCT01078454|B1|Baseline|Arm A (Mel-Dex)|Patients receive melphalan 0.22 mg/kg orally (PO) and dexamethasone 40 mg PO on days 1-4 every 4 weeks. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
365614|NCT01078454|P2|Participant Flow|Arm B (B-Mel-Dex)|Patients receive melphalan 0.22 mg/kg PO and dexamethasone 40 mg PO on days 1-4 and bortezomib 1.3 mg/m^2 intravenously (IV) on days 1, 4, 8, and 11 every 4 weeks. Treatment repeats every 4 weeks for 2 cycles. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22 every 5 weeks. Treatment repeats every 5 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
365615|NCT01078454|P1|Participant Flow|Arm A (Mel-Dex)|Patients receive melphalan 0.22 mg/kg orally (PO) and dexamethasone 40 mg PO on days 1-4 every 4 weeks. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
365616|NCT01078454|O2|Outcome|Arm B (B-Mel-Dex)|Patients receive melphalan 0.22 mg/kg PO and dexamethasone 40 mg PO on days 1-4 and bortezomib 1.3 mg/m^2 intravenously (IV) on days 1, 4, 8, and 11 every 4 weeks. Treatment repeats every 4 weeks for 2 cycles. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22 every 5 weeks. Treatment repeats every 5 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
365617|NCT01078454|O1|Outcome|Arm A (Mel-Dex)|Patients receive melphalan 0.22 mg/kg orally (PO) and dexamethasone 40 mg PO on days 1-4 every 4 weeks. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
365618|NCT01078454|E2|Reported Event|Arm B (B-Mel-Dex)|Patients receive melphalan 0.22 mg/kg PO and dexamethasone 40 mg PO on days 1-4 and bortezomib 1.3 mg/m^2 intravenously (IV) on days 1, 4, 8, and 11 every 4 weeks. Treatment repeats every 4 weeks for 2 cycles. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22 every 5 weeks. Treatment repeats every 5 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
365619|NCT01078454|E1|Reported Event|Arm A (Mel-Dex)|Patients receive melphalan 0.22 mg/kg orally (PO) and dexamethasone 40 mg PO on days 1-4 every 4 weeks. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
365620|NCT01078441|B1|Baseline|Treatment (Combination Chemotherapy)|"Patients receive bortezomib subcutaneously on days 1, 8, and 15; liposomal doxorubicin intravenously (IV) over 1 hour on day 4; oral dexamethasone on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~liposomal doxorubicin: Given IV~bortezomib: Given subcutaneously.~dexamethasone: Given orally~cyclophosphamide: Given IV"
365621|NCT01078441|P1|Participant Flow|Treatment (Combination Chemotherapy)|"Patients receive bortezomib subcutaneously on days 1, 8, and 15; liposomal doxorubicin intravenously (IV) over 1 hour on day 4; oral dexamethasone on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~liposomal doxorubicin: Given IV~bortezomib: Given subcutaneously.~dexamethasone: Given orally~cyclophosphamide: Given IV"
365622|NCT01078441|O1|Outcome|Treatment (Combination Chemotherapy)|"Patients receive bortezomib subcutaneously on days 1, 8, and 15; liposomal doxorubicin intravenously (IV) over 1 hour on day 4; oral dexamethasone on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~liposomal doxorubicin: Given IV~bortezomib: Given subcutaneously.~dexamethasone: Given orally~cyclophosphamide: Given IV"
365623|NCT01078441|E1|Reported Event|Combination Chemotherapy|Patients receive bortezomib subcutaneously on days 1, 8, and 15; liposomal doxorubicin intravenously (IV) over 1 hour on day 4; oral dexamethasone on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
365624|NCT01078402|B4|Baseline|Total|Total of all reporting groups
365625|NCT01078402|B3|Baseline|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
365626|NCT01078402|B2|Baseline|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
365627|NCT01078402|B1|Baseline|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
365628|NCT01078402|P3|Participant Flow|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
365629|NCT01078402|P2|Participant Flow|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
365630|NCT01078402|P1|Participant Flow|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
365631|NCT01078402|O4|Outcome|All Participants (RA, PsA, AS)|Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
365632|NCT01078402|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
365633|NCT01078402|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
365637|NCT01078402|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
365638|NCT01078402|O1|Outcome|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
365639|NCT01078402|O4|Outcome|All Participants (RA, PsA, AS)|Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
365640|NCT01078402|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
365641|NCT01078402|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
365642|NCT01078402|O1|Outcome|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
365643|NCT01078402|O4|Outcome|All Participants (RA, PsA, AS)|Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
365644|NCT01078402|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
365645|NCT01078402|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
365646|NCT01078402|O1|Outcome|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
365647|NCT01078402|O4|Outcome|All Participants (RA, PsA, AS)|Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
365648|NCT01078402|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
365649|NCT01078402|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
365650|NCT01078402|O1|Outcome|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
365651|NCT01078402|O2|Outcome|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
365652|NCT01078402|O1|Outcome|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
365653|NCT01078402|O1|Outcome|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
365654|NCT01078402|E4|Reported Event|All Participants (RA, PsA, AS)|Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
365655|NCT01078402|E3|Reported Event|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
365656|NCT01078402|E2|Reported Event|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
365657|NCT01078402|E1|Reported Event|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
365658|NCT01078389|B3|Baseline|Total|Total of all reporting groups
365659|NCT01078389|B2|Baseline|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
365660|NCT01078389|B1|Baseline|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
365661|NCT01078389|P2|Participant Flow|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
365662|NCT01078389|P1|Participant Flow|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
365663|NCT01078389|O2|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
365664|NCT01078389|O1|Outcome|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
365665|NCT01078389|O2|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
365666|NCT01078389|O1|Outcome|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
365667|NCT01078389|O2|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
365668|NCT01078389|O1|Outcome|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
365669|NCT01078389|O2|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
365670|NCT01078389|O1|Outcome|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
365671|NCT01078389|O2|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
365672|NCT01078389|O1|Outcome|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
365673|NCT01078389|E2|Reported Event|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
365674|NCT01078389|E1|Reported Event|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
365675|NCT01078376|B5|Baseline|Total|Total of all reporting groups
365676|NCT01078376|B4|Baseline|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
365677|NCT01078376|B3|Baseline|Cohort 2: Children (≥6 to <12 Years Old) 20-60 mg|Azilsartan medoxomil 20-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 20 to < 40 kg received a 20 mg dose, participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
365678|NCT01078376|B2|Baseline|Cohort 1: Adolescents (≥12 to <17 Years Old) 40-60 mg|Azilsartan medoxomil 40-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
365679|NCT01078376|B1|Baseline|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
365680|NCT01078376|P4|Participant Flow|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
365681|NCT01078376|P3|Participant Flow|Cohort 2: Children (≥6 to <12 Years Old) 20-60 mg|Azilsartan medoxomil 20-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 20 to < 40 kg received a 20 mg dose, participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
365682|NCT01078376|P2|Participant Flow|Cohort 1: Adolescents (≥12 to <17 Years Old) 40-60 mg|Azilsartan medoxomil 40-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
365683|NCT01078376|P1|Participant Flow|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
365684|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
365685|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365686|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365687|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365688|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365689|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
365690|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
365691|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365692|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365693|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365694|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365695|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
365696|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
365697|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365698|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365699|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365700|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365701|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
365702|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
365703|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365704|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365705|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365706|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365707|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
365708|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
365709|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365710|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365711|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365712|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365713|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
365714|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
365715|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365716|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365717|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365718|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365719|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
365720|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
365721|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
365722|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365723|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365724|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365725|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365726|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
365727|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
365728|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
365729|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365730|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365731|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365732|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365733|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
365734|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
365735|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
365736|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365737|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365738|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365739|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365740|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
365741|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
365742|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
365743|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365744|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365745|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365746|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365747|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
365748|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
365749|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
365750|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365751|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365752|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365753|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365754|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
365755|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
365756|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
365757|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365758|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365759|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365760|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365761|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
365762|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
365763|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
365764|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365765|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365766|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365767|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365768|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
365769|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
365770|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
365771|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365772|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365773|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365774|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365775|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
365776|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
365777|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
365778|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365779|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365780|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365781|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365782|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
365783|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
365784|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
365785|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365786|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365787|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365788|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365789|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
365790|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
365791|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
365792|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365793|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365794|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
365795|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
365796|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
365797|NCT01078376|E4|Reported Event|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
365798|NCT01078376|E3|Reported Event|Cohort 2: Children (≥6 to <12 Years Old) 20-60 mg|Azilsartan medoxomil 20-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 20 to < 40 kg received a 20 mg dose, participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
365799|NCT01078376|E2|Reported Event|Cohort 1: Adolescents (≥12 to <17 Years Old) 40-60 mg|Azilsartan medoxomil 40-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
365800|NCT01078376|E1|Reported Event|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
365801|NCT01078363|B3|Baseline|Total|Total of all reporting groups
365802|NCT01078363|B2|Baseline|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
365803|NCT01078363|B1|Baseline|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
365804|NCT01078363|P2|Participant Flow|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
365805|NCT01078363|P1|Participant Flow|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
365806|NCT01078363|O2|Outcome|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
365807|NCT01078363|O1|Outcome|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
365808|NCT01078363|O2|Outcome|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
365809|NCT01078363|O1|Outcome|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
365810|NCT01078363|O2|Outcome|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
365811|NCT01078363|O1|Outcome|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
365812|NCT01078363|O2|Outcome|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~Placebo: Use of a placebo post heart Transplant for Blood pressure control."
365813|NCT01078363|O1|Outcome|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril: Use of a ACE ( angiotension converting enzyme) inhibitors post heart Transplant for Blood pressure control."
365814|NCT01078363|O2|Outcome|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
365815|NCT01078363|O1|Outcome|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
366097|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
365816|NCT01078363|O2|Outcome|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
365817|NCT01078363|O1|Outcome|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
365818|NCT01078363|E2|Reported Event|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
365819|NCT01078363|E1|Reported Event|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
365820|NCT01078298|B3|Baseline|Total|Total of all reporting groups
365821|NCT01078298|B2|Baseline|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365822|NCT01078298|B1|Baseline|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365823|NCT01078298|P2|Participant Flow|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365824|NCT01078298|P1|Participant Flow|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365825|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365826|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365827|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365828|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365829|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365830|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365831|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365832|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365833|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365834|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365835|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365836|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365837|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365838|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365839|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365840|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365841|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365842|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365843|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365844|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365845|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365846|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365847|NCT01078298|E2|Reported Event|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365848|NCT01078298|E1|Reported Event|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
365849|NCT01078246|B8|Baseline|Total|Total of all reporting groups
365850|NCT01078246|B7|Baseline|Historical, Concurrent and Raltegravir Cohorts|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), 2) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 3) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to all three cohorts.
365851|NCT01078246|B6|Baseline|Concurrent and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 2) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Concurrent and Raltegravir Cohorts only.
365852|NCT01078246|B5|Baseline|Concurrent Cohort Only|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Concurrent Cohort only.
365853|NCT01078246|B4|Baseline|Historical and Concurrent Cohorts Only|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Historical and Concurrent Cohorts only.
365854|NCT01078246|B3|Baseline|Historical Cohort Only|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort). These participants contributed data to the Historical Cohort only.
365855|NCT01078246|B2|Baseline|Historical and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received RAL on or after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Historical and Raltegravir Cohorts only.
365856|NCT01078246|B1|Baseline|Raltegravir Cohort Only|Participants with HIV-1 infection who received raltegravir (RAL) on or after 12 October 2007 (the market authorization date in the United States) (Raltegravir Cohort). These participants contributed data to the Raltegravir Cohort only.
365857|NCT01078246|P7|Participant Flow|Historical, Concurrent and Raltegravir Cohorts|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), 2) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 3) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to all three cohorts.
365858|NCT01078246|P6|Participant Flow|Concurrent and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 2) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Concurrent and Raltegravir Cohorts only.
365859|NCT01078246|P5|Participant Flow|Concurrent Cohort Only|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Concurrent Cohort only.
365884|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
366150|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
365860|NCT01078246|P4|Participant Flow|Historical and Concurrent Cohorts Only|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Historical and Concurrent Cohorts only.
365861|NCT01078246|P3|Participant Flow|Historical Cohort Only|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort). These participants contributed data to the Historical Cohort only.
365862|NCT01078246|P2|Participant Flow|Historical and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received RAL on or after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Historical and Raltegravir Cohorts only.
365863|NCT01078246|P1|Participant Flow|Raltegravir Cohort Only|Participants with HIV-1 infection who received raltegravir (RAL) on or after 12 October 2007 (the market authorization date in the United States) (Raltegravir Cohort). These participants contributed data to the Raltegravir Cohort only.
365864|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
365865|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
365866|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
365867|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
365868|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
365869|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
365870|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
365871|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
365872|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
365873|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
365874|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
365875|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
365876|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
365877|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
365878|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
365879|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
365880|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
365881|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
365882|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
365883|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
366094|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
365885|NCT01078246|E3|Reported Event|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
365886|NCT01078246|E2|Reported Event|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
365887|NCT01078246|E1|Reported Event|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
365888|NCT01078233|B7|Baseline|Total|Total of all reporting groups
365889|NCT01078233|B6|Baseline|Concurrent and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Concurrent Cohort and the Raltegravir Cohort.
365890|NCT01078233|B5|Baseline|Concurrent Cohort Only|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data only to the Concurrent Cohort.
365891|NCT01078233|B4|Baseline|Historical and Concurrent Cohorts|Participants with HIV-1 infection who 1) started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data to the Historical Cohort and the Concurrent Cohort.
365892|NCT01078233|B3|Baseline|Historical Cohort Only|Participants with HIV-1 infection who started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in this cohort. These participants contributed data only to the Historical Cohort.
365893|NCT01078233|B2|Baseline|Historical and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Historical Cohort and the Raltegravir Cohort.
365894|NCT01078233|B1|Baseline|Raltegravir Cohort Only|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union). Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in this cohort. These participants contributed data only to the Raltegravir Cohort.
365895|NCT01078233|P6|Participant Flow|Concurrent and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Concurrent Cohort and the Raltegravir Cohort.
365896|NCT01078233|P5|Participant Flow|Concurrent Cohort Only|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data only to the Concurrent Cohort.
365897|NCT01078233|P4|Participant Flow|Historical and Concurrent Cohorts|Participants with HIV-1 infection who 1) started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data to the Historical Cohort and the Concurrent Cohort.
365898|NCT01078233|P3|Participant Flow|Historical Cohort Only|Participants with HIV-1 infection who started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in this cohort. These participants contributed data only to the Historical Cohort.
365899|NCT01078233|P2|Participant Flow|Historical and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Historical Cohort and the Raltegravir Cohort.
365900|NCT01078233|P1|Participant Flow|Raltegravir Cohort Only|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union). Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in this cohort. These participants contributed data only to the Raltegravir Cohort.
365901|NCT01078233|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
365902|NCT01078233|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
366095|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
365903|NCT01078233|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
365904|NCT01078233|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
365905|NCT01078233|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
365906|NCT01078233|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
365907|NCT01078233|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
365908|NCT01078233|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
365909|NCT01078233|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
365910|NCT01078233|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
365911|NCT01078233|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
365912|NCT01078233|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
365913|NCT01078233|E3|Reported Event|Concurrent Cohort|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
365914|NCT01078233|E2|Reported Event|Historical Cohort|Participants with HIV-1 infection who started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
365915|NCT01078233|E1|Reported Event|Raltegravir Cohort|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
365916|NCT01078220|B1|Baseline|Any Dose Safety Population|Any female who received any dose of Gardasil at a managed care organization (MCO) between August 2006 and March 2008.
365917|NCT01078220|P1|Participant Flow|Any Dose Safety Population|Any female who received any dose of Gardasil at a managed care organization (MCO) between August 2006 and March 2008.
365918|NCT01078220|O2|Outcome|3-Dose Safety Population|Any female who was 9-26 years old at first dose of Gardasil and who was a MCO member at each dose, and who had a minimum of 28 days between doses 1 and 2, and 12 weeks between doses 2 and 3, and who received all 3 doses of Gardasil within 12 months
365919|NCT01078220|O1|Outcome|Any Dose Safety Population|Any female who received any dose of Gardasil at a MCO between August 2006 and March 2008.
365920|NCT01078220|O1|Outcome|Autoimmune Safety Population|Any female with at least 12 months of membership at a MCO prior to their first dose of Gardasil, in order to exclude pre-existing conditions prior to their first dose of Gardasil.
365921|NCT01078220|O1|Outcome|Pregnancy Safety Population|Any female from the Any Dose Safety Population with suspected exposure to Gardasil during pregnancy.
365922|NCT01078220|O1|Outcome|Pregnancy Safety Population|Any female from the Any Dose Safety Population with suspected exposure to Gardasil during pregnancy.
365923|NCT01078220|O2|Outcome|3-Dose Safety Population|Any female who was 9-26 years old at first dose of Gardasil and who was a MCO member at each dose, and who had a minimum of 28 days between doses 1 and 2, and 12 weeks between doses 2 and 3, and who received all 3 doses of Gardasil within 12 months
365924|NCT01078220|O1|Outcome|Any Dose Safety Population|Any female who received any dose of Gardasil at a MCO between August 2006 and March 2008.
365925|NCT01078220|E1|Reported Event|Any Dose Safety Population|Any female who received any dose of Gardasil at a managed care organization (MCO) between August 2006 and March 2008.
365926|NCT01078207|B1|Baseline|Adult Surgical Patients At Risk for Obstructive Sleep Apnea|Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group.
370634|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
365927|NCT01078207|P1|Participant Flow|Adult Surgical Patients At Risk for Obstructive Sleep Apnea|Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group.
365928|NCT01078207|O1|Outcome|Adult Surgical Patients At Risk for Obstructive Sleep Apnea|Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group.
365929|NCT01078207|O1|Outcome|Adult Surgical Patients At Risk for Obstructive Sleep Apnea|Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group.
365930|NCT01078207|E1|Reported Event|Adult Surgical Patients At Risk for Obstructive Sleep Apnea|Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group.
365931|NCT01078168|B3|Baseline|Total|Total of all reporting groups
365932|NCT01078168|B2|Baseline|Placebo|"oral, day 1-28~Placebo: Placebo"
365933|NCT01078168|B1|Baseline|Acitretin|"oral, 30 mg per day, day 1-28~Acitretin: 30mg per day from Day 1 to Day 28"
365934|NCT01078168|P2|Participant Flow|Placebo|"oral, day 1-28~Placebo: Placebo"
365935|NCT01078168|P1|Participant Flow|Acitretin|"oral, 30 mg per day, day 1-28~Acitretin: 30mg per day from Day 1 to Day 28"
365936|NCT01078168|O2|Outcome|Placebo|"oral, day 1-28~Placebo: Placebo"
365937|NCT01078168|O1|Outcome|Acitretin|"oral, 30 mg per day, day 1-28~Acitretin: 30mg per day from Day 1 to Day 28"
365938|NCT01078168|E2|Reported Event|Placebo|"oral, day 1-28~Placebo: Placebo"
365939|NCT01078168|E1|Reported Event|Acitretin|"oral, 30 mg per day, day 1-28~Acitretin: 30mg per day from Day 1 to Day 28"
365940|NCT01078155|B1|Baseline|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
365941|NCT01078155|P1|Participant Flow|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-tumor necrosis factor (TNF) was taken prior to a participant’s enrollment in the study.
365942|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
365943|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
365944|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
365945|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
365946|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
365947|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
365948|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
365949|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
370635|NCT01067976|O1|Outcome|CMRM vs UMRM|
365950|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
365951|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
365952|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
365953|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
365954|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
365955|NCT01078155|E1|Reported Event|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
365956|NCT01078116|B1|Baseline|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
365957|NCT01078116|P1|Participant Flow|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
365958|NCT01078116|O1|Outcome|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
365959|NCT01078116|O1|Outcome|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
365960|NCT01078116|O1|Outcome|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
365961|NCT01078116|O1|Outcome|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
365962|NCT01078116|O1|Outcome|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
365963|NCT01078116|E1|Reported Event|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
365964|NCT01078090|B1|Baseline|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
365965|NCT01078090|P1|Participant Flow|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
365966|NCT01078090|O10|Outcome|Month 60|60 months after inclusion
365967|NCT01078090|O9|Outcome|Month 48|48 months after inclusion
365968|NCT01078090|O8|Outcome|Month 36|36 months after inclusion
365969|NCT01078090|O7|Outcome|Month 30|30 months after inclusion
365970|NCT01078090|O6|Outcome|Month 24|24 months after inclusion
365971|NCT01078090|O5|Outcome|Month 18|18 months after inclusion
365972|NCT01078090|O4|Outcome|Month 12|12 months after inclusion
365973|NCT01078090|O3|Outcome|Month 6|6 months after inclusion
365974|NCT01078090|O2|Outcome|Month 3|3 months after inclusion
365975|NCT01078090|O1|Outcome|Month 0|Baseline
365976|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
365977|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
365978|NCT01078090|O5|Outcome|Month 30|30 months after inclusion
365979|NCT01078090|O4|Outcome|Month 24|24 months after inclusion
365980|NCT01078090|O3|Outcome|Month 18|18 months after inclusion
365981|NCT01078090|O2|Outcome|Month 6|6 months after inclusion
365982|NCT01078090|O1|Outcome|Month 0|Baseline
365983|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
365984|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
365985|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
365986|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
365987|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
365988|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
365989|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
365990|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
365991|NCT01078090|O10|Outcome|Month 60|60 months after inclusion
365992|NCT01078090|O9|Outcome|Month 48|48 months after inclusion
365993|NCT01078090|O8|Outcome|Month 36|36 months after inclusion
365994|NCT01078090|O7|Outcome|Month 30|30 months after inclusion
365995|NCT01078090|O6|Outcome|Month 24|24 months after inclusion
365996|NCT01078090|O5|Outcome|Month 18|18 months after inclusion
365997|NCT01078090|O4|Outcome|Month 12|12 months after inclusion
365998|NCT01078090|O3|Outcome|Month 6|6 months after inclusion
365999|NCT01078090|O2|Outcome|Month 3|3 months after inclusion
366000|NCT01078090|O1|Outcome|Month 0|Baseline
366001|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
366002|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
366003|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
366004|NCT01078090|E1|Reported Event|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
366005|NCT01077973|B4|Baseline|Total|Total of all reporting groups
366006|NCT01077973|B3|Baseline|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366007|NCT01077973|B2|Baseline|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
366008|NCT01077973|B1|Baseline|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366009|NCT01077973|P3|Participant Flow|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366010|NCT01077973|P2|Participant Flow|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
366011|NCT01077973|P1|Participant Flow|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366012|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366013|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
366014|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366015|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366016|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
366017|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366018|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366019|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
366020|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366021|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366022|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
370636|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
366023|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366024|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366025|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
366026|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366027|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366028|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
366029|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366030|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366031|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
366032|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366033|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366034|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
366035|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366036|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366037|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
366038|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366039|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366040|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
366041|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366042|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366043|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
366044|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366045|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366046|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
366047|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366048|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366049|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
366050|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366051|NCT01077973|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366052|NCT01077973|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
366096|NCT01077921|O2|Outcome|Placebo|All subjects completing the placebo treatment phase.
366053|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
366054|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366055|NCT01077973|E3|Reported Event|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366056|NCT01077973|E2|Reported Event|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
366057|NCT01077973|E1|Reported Event|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
366058|NCT01077960|B1|Baseline|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
366059|NCT01077960|P1|Participant Flow|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
366060|NCT01077960|O1|Outcome|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
366061|NCT01077960|O1|Outcome|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
366062|NCT01077960|O1|Outcome|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
366063|NCT01077960|O1|Outcome|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
366064|NCT01077960|O1|Outcome|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
366065|NCT01077960|O1|Outcome|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
366066|NCT01077960|E1|Reported Event|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
366067|NCT01077921|B3|Baseline|Total|Total of all reporting groups
366068|NCT01077921|B2|Baseline|Placebo-first|Cross-over study comprising treatment with placebo for 6 weeks, followed by a 2 weeks period washout, then similar treatment period with propranolol with a standard dose of 40 mg every 12 hrs., followed by another 2 weeks washout period
366069|NCT01077921|B1|Baseline|Propranolol-first|Cross-over study comprising treatment with propranolol for 6 weeks with a standard dose of 40 mg every 12 hrs, followed by a 2 weeks period washout, then similar treatment period with placebo followed by another 2 weeks washout period
366070|NCT01077921|P2|Participant Flow|Placebo-first|Cross-over study comprising treatment with placebo for 6 weeks, followed by a 2 weeks period washout, then similar treatment period with propranolol with a standard dose of 40 mg every 12 hrs., followed by another 2 weeks washout period.
366071|NCT01077921|P1|Participant Flow|Propranolol-first|Cross-over study comprising treatment with propranolol for 6 weeks with a standard dose of 40 mg every 12 hrs, followed by a 2 weeks period washout, then similar treatment period with placebo followed by another 2 weeks washout period
366072|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
366073|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
366074|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
366075|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
366076|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
366077|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
366078|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
366079|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
366080|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
366081|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
366082|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
366083|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
366084|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
366085|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
366086|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
366087|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
366088|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
366089|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
366090|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
366091|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
366092|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
366093|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
366098|NCT01077921|E2|Reported Event|Placebo|Placebo: Treatment will be with a standard propranolol dose of 40 mg every 12 hrs.Each patient will participate in 6 weeks of treatment with placebo or study drug (propranolol), followed by a 2-week wash-out period and then 6 weeks of treatment with the other modality (placebo or propranolol).
366099|NCT01077921|E1|Reported Event|Propranolol|Propranolol: Treatment will be with a standard propranolol dose of 40 mg every 12 hrs.Each patient will participate in 6 weeks of treatment with placebo or study drug (propranolol), followed by a 2-week wash-out period and then 6 weeks of treatment with the other modality (placebo or propranolol).
366100|NCT01077856|B4|Baseline|Total|Total of all reporting groups
366101|NCT01077856|B3|Baseline|Sweden Participants|Participants in Sweden who completed the first survey (before licensure of GARDASIL)
366102|NCT01077856|B2|Baseline|Norway Participants|Participants in Norway who completed the first survey (before licensure of GARDASIL)
366103|NCT01077856|B1|Baseline|Denmark Participants|Participants in Denmark who completed the first survey (before licensure of GARDASIL)
366104|NCT01077856|P3|Participant Flow|Sweden Participants|Participants in Sweden who completed the first survey (before licensure of GARDASIL)
366105|NCT01077856|P2|Participant Flow|Norway Participants|Participants in Norway who completed the first survey (before licensure of GARDASIL)
366106|NCT01077856|P1|Participant Flow|Denmark Participants|Participants in Denmark who completed the first survey (before licensure of GARDASIL)
366107|NCT01077856|O6|Outcome|Sweden Participants Who Did Not Receive Gardasil|
366108|NCT01077856|O5|Outcome|Sweden Participants Who Received Gardasil|Sweden participants who received Gardasil on or before March 2012
366109|NCT01077856|O4|Outcome|Norway Participants Who Did Not Receive Gardasil|
366110|NCT01077856|O3|Outcome|Norway Participants Who Received Gardasil|Norway participants who received Gardasil on or before March 2012
366111|NCT01077856|O2|Outcome|Denmark Participants Who Did Not Receive Gardasil|
366112|NCT01077856|O1|Outcome|Denmark Participants Who Received Gardasil|Denmark participants who received Gardasil on or before March 2012
366113|NCT01077856|O6|Outcome|Sweden Participants Who Did Not Receive Gardasil|
366114|NCT01077856|O5|Outcome|Sweden Participants Who Received Gardasil|Sweden participants who received Gardasil on or before March 2012
366115|NCT01077856|O4|Outcome|Norway Participants Who Did Not Receive Gardasil|
366116|NCT01077856|O3|Outcome|Norway Participants Who Received Gardasil|Norway participants who received Gardasil on or before March 2012
366117|NCT01077856|O2|Outcome|Denmark Participants Who Did Not Receive Gardasil|
366118|NCT01077856|O1|Outcome|Denmark Participants Who Received Gardasil|Denmark participants who received Gardasil on or before March 2012
366119|NCT01077856|O6|Outcome|Sweden Participants Who Did Not Receive Gardasil|
366120|NCT01077856|O5|Outcome|Sweden Participants Who Received Gardasil|Sweden participants who received Gardasil on or before March 2012
366121|NCT01077856|O4|Outcome|Norway Participants Who Did Not Receive Gardasil|
366122|NCT01077856|O3|Outcome|Norway Participants Who Received Gardasil|Norway participants who received Gardasil on or before March 2012
366123|NCT01077856|O2|Outcome|Denmark Participants Who Did Not Receive Gardasil|
366124|NCT01077856|O1|Outcome|Denmark Participants Who Received Gardasil|Denmark participants who received Gardasil on or before March 2012
366125|NCT01077856|O6|Outcome|Sweden Participants Who Did Not Receive Gardasil|
366126|NCT01077856|O5|Outcome|Sweden Participants Who Received Gardasil|Sweden participants who received Gardasil on or before March 2012
366127|NCT01077856|O4|Outcome|Norway Participants Who Did Not Receive Gardasil|
366128|NCT01077856|O3|Outcome|Norway Participants Who Received Gardasil|Norway participants who received Gardasil on or before March 2012
366129|NCT01077856|O2|Outcome|Denmark Participants Who Did Not Receive Gardasil|
366130|NCT01077856|O1|Outcome|Denmark Participants Who Received Gardasil|Denmark participants who received Gardasil on or before March 2012
366131|NCT01077856|O6|Outcome|Babies Born to Sweden Participants|Live babies born between 2007 and 2011 to Sweden participants in the general population, including participants who did and did not received Gardasil
366132|NCT01077856|O5|Outcome|Babies Born to Sweden Participants Who Received Gardasil|Live babies born between 2007 and 2011 to Sweden participants who received Gardasil during pregnancy
366133|NCT01077856|O4|Outcome|Babies Born to Norway Participants|Live babies born between 2007 and 2011 to Norway participants in the general population, including participants who did and did not receive Gardasil
366134|NCT01077856|O3|Outcome|Babies Born to Norway Participants Who Received Gardasil|Live babies born between 2007 and 2011 to Norway participants who received Gardasil during pregnancy
366135|NCT01077856|O2|Outcome|Babies Born to Denmark Participants|Live babies born between 2007 and 2011 to Denmark participants in the general population, including participants who did and did not receive Gardasil
366136|NCT01077856|O1|Outcome|Babies Born to Denmark Participants Who Received Gardasil|Live babies born between 2007 and 2011 to Denmark participants who received Gardasil during pregnancy
366137|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
366138|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
366139|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
366140|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
366141|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
366142|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
366143|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
366144|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
366145|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
366146|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
366147|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
366148|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
366149|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
370637|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
366151|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
366152|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
366153|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
366154|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
366155|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
366156|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
366157|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
366158|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
366159|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
366160|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
366161|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
366162|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
366163|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
366164|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
366165|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
366166|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
366167|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
366168|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
366169|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
366170|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
366171|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
366172|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
366173|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
366174|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
366175|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
366176|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
366177|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
366178|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
366179|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
366180|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
366181|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
366182|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
366183|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
366184|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
366185|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
366186|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
366187|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
366188|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
366189|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
366190|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
366191|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
366192|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
366193|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
366194|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
366195|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
366196|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
366197|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
366198|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
366199|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
366200|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
366201|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
366202|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
366203|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
366204|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
366205|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
366206|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
366207|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
366208|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
366209|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
366210|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
366211|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
366212|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
366213|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
366214|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
366215|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
366216|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
366217|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
366218|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
366219|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
366220|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
366221|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
366222|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
366223|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
366224|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
366225|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
366226|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
366227|NCT01077856|O6|Outcome|Sweden Participants 2011 After Gardasil Licensure|
366228|NCT01077856|O5|Outcome|Sweden Participants 2010 After Gardasil Licensure|
366229|NCT01077856|O4|Outcome|Sweden Participants 2009 After Gardasil Licensure|
366230|NCT01077856|O3|Outcome|Sweden Participants 2008 After Gardasil Licensure|
366231|NCT01077856|O2|Outcome|Sweden Participants 2007, After Gardasil Licensure|
366232|NCT01077856|O1|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
366233|NCT01077856|O6|Outcome|Sweden Participants 2011 After Gardasil Licensure|
366234|NCT01077856|O5|Outcome|Sweden Participants 2010 After Gardasil Licensure|
366235|NCT01077856|O4|Outcome|Sweden Participants 2009 After Gardasil Licensure|
366236|NCT01077856|O3|Outcome|Sweden Participants 2008 After Gardasil Licensure|
366237|NCT01077856|O2|Outcome|Sweden Participants 2007, After Gardasil Licensure|
366238|NCT01077856|O1|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
366239|NCT01077856|O6|Outcome|Sweden Participants 2011 After Gardasil Licensure|
366240|NCT01077856|O5|Outcome|Sweden Participants 2010 After Gardasil Licensure|
366241|NCT01077856|O4|Outcome|Sweden Participants 2009 After Gardasil Licensure|
366242|NCT01077856|O3|Outcome|Sweden Participants 2008 After Gardasil Licensure|
366243|NCT01077856|O2|Outcome|Sweden Participants 2007, After Gardasil Licensure|
366244|NCT01077856|O1|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
366245|NCT01077856|O6|Outcome|Norway Participants 2011 After Gardasil Licensure|
366246|NCT01077856|O5|Outcome|Norway Participants 2010 After Gardasil Licensure|
366247|NCT01077856|O4|Outcome|Norway Participants 2009 After Gardasil Licensure|
366248|NCT01077856|O3|Outcome|Norway Participants 2008 After Gardasil Licensure|
366249|NCT01077856|O2|Outcome|Norway Participants 2007, After Gardasil Licensure|
366250|NCT01077856|O1|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
366251|NCT01077856|O6|Outcome|Norway Participants 2011 After Gardasil Licensure|
366252|NCT01077856|O5|Outcome|Norway Participants 2010 After Gardasil Licensure|
366253|NCT01077856|O4|Outcome|Norway Participants 2009 After Gardasil Licensure|
366254|NCT01077856|O3|Outcome|Norway Participants 2008 After Gardasil Licensure|
366255|NCT01077856|O2|Outcome|Norway Participants 2007, After Gardasil Licensure|
366256|NCT01077856|O1|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
366257|NCT01077856|O6|Outcome|Norway Participants 2011 After Gardasil Licensure|
366258|NCT01077856|O5|Outcome|Norway Participants 2010 After Gardasil Licensure|
366259|NCT01077856|O4|Outcome|Norway Participants 2009 After Gardasil Licensure|
366260|NCT01077856|O3|Outcome|Norway Participants 2008 After Gardasil Licensure|
366261|NCT01077856|O2|Outcome|Norway Participants 2007, After Gardasil Licensure|
366262|NCT01077856|O1|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
366263|NCT01077856|O6|Outcome|Denmark Participants 2011 After Gardasil Licensure|
366264|NCT01077856|O5|Outcome|Denmark Participants 2010 After Gardasil Licensure|
366265|NCT01077856|O4|Outcome|Denmark Participants 2009 After Gardasil Licensure|
366266|NCT01077856|O3|Outcome|Denmark Participants 2008 After Gardasil Licensure|
366267|NCT01077856|O2|Outcome|Denmark Participants 2007, After Gardasil Licensure|
366268|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
366269|NCT01077856|O6|Outcome|Denmark Participants 2011 After Gardasil Licensure|
366270|NCT01077856|O5|Outcome|Denmark Participants 2010 After Gardasil Licensure|
366271|NCT01077856|O4|Outcome|Denmark Participants 2009 After Gardasil Licensure|
366272|NCT01077856|O3|Outcome|Denmark Participants 2008 After Gardasil Licensure|
366273|NCT01077856|O2|Outcome|Denmark Participants 2007, After Gardasil Licensure|
366274|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
366275|NCT01077856|O6|Outcome|Denmark Participants 2011 After Gardasil Licensure|
366276|NCT01077856|O5|Outcome|Denmark Participants 2010 After Gardasil Licensure|
366277|NCT01077856|O4|Outcome|Denmark Participants 2009 After Gardasil Licensure|
366278|NCT01077856|O3|Outcome|Denmark Participants 2008 After Gardasil Licensure|
366279|NCT01077856|O2|Outcome|Denmark Participants 2007, After Gardasil Licensure|
366280|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
366281|NCT01077856|E3|Reported Event|Sweden Participants|All Sweden study participants
366282|NCT01077856|E2|Reported Event|Norway Participants|All Norway study participants
366283|NCT01077856|E1|Reported Event|Denmark Participants|All Denmark study participants
366284|NCT01077830|B3|Baseline|Total|Total of all reporting groups
366285|NCT01077830|B2|Baseline|Placebo|Participants who received placebo in the base study
366286|NCT01077830|B1|Baseline|Ezetimibe/Simvastatin 10/40 mg|Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
366287|NCT01077830|P2|Participant Flow|Placebo|Participantss who received placebo in the base study
366288|NCT01077830|P1|Participant Flow|Ezetimibe/Simvastatin 10/40 mg|Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
366289|NCT01077830|O2|Outcome|Placebo|Participants who received placebo in the base study
366290|NCT01077830|O1|Outcome|Ezetimibe/Simvastatin 10/40 mg|Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
366291|NCT01077830|O2|Outcome|Placebo|Participants who received placebo in the base study
366781|NCT01077076|O2|Outcome|Prilosec OTC Tablets|20 mg-equivalent omeprazole
366292|NCT01077830|O1|Outcome|Ezetimibe/Simvastatin 10/40 mg|Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
366293|NCT01077830|O2|Outcome|Placebo|Participants who received placebo in the base study
366294|NCT01077830|O1|Outcome|Ezetimibe/Simvastatin 10/40 mg|Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
366295|NCT01077830|E2|Reported Event|Placebo|Participants who were assigned to the placebo cohort in the base study
366296|NCT01077830|E1|Reported Event|Ezetimibe/Simvastatin 10/40 mg|Participants who were assigned to the Ezetimibe/Simvastatin 10/40 mg cohort in the base study
366297|NCT01077817|B1|Baseline|Overall Study Population|
366298|NCT01077817|P1|Participant Flow|Overall Study Population|
366299|NCT01077817|O6|Outcome|Raloxifene|Participants who initiated osteoporosis treatment with raloxifene
366300|NCT01077817|O5|Outcome|Risendronate|Participants who initiated osteoporosis treatment with risedronate
366301|NCT01077817|O4|Outcome|Ibandronate|Participants who initiated osteoporosis treatment with ibandronate
366302|NCT01077817|O3|Outcome|Etidronate|Participants who initiated osteoporosis treatment with etidronate
366303|NCT01077817|O2|Outcome|Alendronate|Participants who initiated osteoporosis treatment with alendronate
366304|NCT01077817|O1|Outcome|Comparators|Participants who did not initiate osteoporosis treatment with a study drug
366305|NCT01077817|O2|Outcome|Comparison Sample (Case Cohort)|Participants who were matched to cases by age and membership in the GPRD on the case's onset date, and had not experienced any form of esophageal cancer or Paget's Disease and had not received oral or intravenous steroids or chemotherapy or radiotherapy, as indicated by GPRD codes.
366306|NCT01077817|O1|Outcome|Esophageal Cancer Cohort|Participants with any GPRD Medical Code for esophageal cancer (cases).
366307|NCT01077817|E1|Reported Event|Overall Study Population|
366308|NCT01077804|B1|Baseline|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
366309|NCT01077804|P1|Participant Flow|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
366310|NCT01077804|O1|Outcome|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
366311|NCT01077804|O1|Outcome|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
366312|NCT01077804|O1|Outcome|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
366313|NCT01077804|O1|Outcome|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
366314|NCT01077804|E1|Reported Event|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
366315|NCT01077739|B3|Baseline|Total|Total of all reporting groups
366316|NCT01077739|B2|Baseline|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
366317|NCT01077739|B1|Baseline|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
366318|NCT01077739|P2|Participant Flow|Bevacizumab + 5-fluorouracil/Oxaliplatin/Leucovorin (FOLFOX)|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-fluorouracil [5-FU] plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
366319|NCT01077739|P1|Participant Flow|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1; oxaliplatin 130 mg per square meter (mg/m^2) IV on Day 1; and capecitabine 1000 mg/m^2, orally (PO), twice daily (BID) on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
366320|NCT01077739|O2|Outcome|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
366321|NCT01077739|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
366339|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
366322|NCT01077739|O2|Outcome|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
366323|NCT01077739|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
366324|NCT01077739|O2|Outcome|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
366325|NCT01077739|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
366326|NCT01077739|O2|Outcome|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
366327|NCT01077739|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
366328|NCT01077739|E2|Reported Event|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
366329|NCT01077739|E1|Reported Event|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
366330|NCT01077713|B3|Baseline|Total|Total of all reporting groups
366331|NCT01077713|B2|Baseline|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
366332|NCT01077713|B1|Baseline|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
366333|NCT01077713|P2|Participant Flow|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
366334|NCT01077713|P1|Participant Flow|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 and gemcitabine 1200 milligrams per square meter (mg/m^2) IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
366335|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
366336|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
366337|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
366338|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
366357|NCT01077622|B1|Baseline|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366340|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
366341|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
366342|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
366343|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
366344|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
366345|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
366346|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
366347|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
366348|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
366349|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
366350|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
366351|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
366352|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
366353|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
366354|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
366355|NCT01077713|E2|Reported Event|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
366356|NCT01077713|E1|Reported Event|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
366433|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular ‘other’ antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date
366358|NCT01077622|P1|Participant Flow|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366359|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366360|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366361|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366362|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366363|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366364|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366365|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366366|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366367|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366368|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366369|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366370|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366371|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366372|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366373|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366374|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366375|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366376|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366377|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366378|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366434|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
366379|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366380|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366381|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366382|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366383|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366384|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366385|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366386|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366387|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366388|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366389|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366390|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366391|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366392|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366393|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366394|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366395|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366396|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366397|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366398|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366399|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366435|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date
370638|NCT01067976|O1|Outcome|CMRM vs UMRM|
366400|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366401|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366402|NCT01077622|E1|Reported Event|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
366403|NCT01077596|B13|Baseline|Total|Total of all reporting groups
366404|NCT01077596|B12|Baseline|New Antidepressant Exposure in Prostate Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Controls
366405|NCT01077596|B11|Baseline|New Antidepressant Exposure in Prostate Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Cases
366406|NCT01077596|B10|Baseline|New Antidepressant Exposure in Breast Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Controls
366407|NCT01077596|B9|Baseline|New Antidepressant Exposure in Breast Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Cases
366408|NCT01077596|B8|Baseline|New Antidepressant Exposure in Uterine Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Controls
366409|NCT01077596|B7|Baseline|New Antidepressant Exposure in Uterine Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Cases
366410|NCT01077596|B6|Baseline|New Antidepressant Exposure in Bladder Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Controls
366411|NCT01077596|B5|Baseline|New Antidepressant Exposure in Bladder Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Cases
366412|NCT01077596|B4|Baseline|New Antidepressant Exposure in Lung Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Controls
366413|NCT01077596|B3|Baseline|New Antidepressant Exposure in Lung Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Cases
366414|NCT01077596|B2|Baseline|New Antidepressant Exposure in Colorectal Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Controls
366415|NCT01077596|B1|Baseline|New Antidepressant Exposure in Colorectal Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Cases
366416|NCT01077596|P12|Participant Flow|New Antidepressant Exposure in Prostate Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Controls
366417|NCT01077596|P11|Participant Flow|New Antidepressant Exposure in Prostate Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Cases
366418|NCT01077596|P10|Participant Flow|New Antidepressant Exposure in Breast Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Controls
366419|NCT01077596|P9|Participant Flow|New Antidepressant Exposure in Breast Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Cases
366420|NCT01077596|P8|Participant Flow|New Antidepressant Exposure in Uterine Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Controls
366421|NCT01077596|P7|Participant Flow|Antidepressant Exposure in Uterine Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Cases
366422|NCT01077596|P6|Participant Flow|New Antidepressant Exposure in Bladder Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Controls
366423|NCT01077596|P5|Participant Flow|New Antidepressant Exposure in Bladder Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Cases
366424|NCT01077596|P4|Participant Flow|New Antidepressant Exposure in Lung Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Controls
366425|NCT01077596|P3|Participant Flow|New Antidepressant Exposure in Lung Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Cases
366426|NCT01077596|P2|Participant Flow|New Antidepressant Exposure in Colorectal Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Controls
366427|NCT01077596|P1|Participant Flow|New Antidepressant Exposure in Colorectal Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Cases
366428|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular ‘other’ antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date
366429|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
366430|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date
366431|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
366432|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
366436|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
366437|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
366438|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular ‘other’ antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date
366439|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
366440|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date
366441|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
366442|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
366443|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular ‘other’ antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date
366444|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
366445|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date
366446|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
366447|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
366448|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular ‘other’ antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date
366449|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
366450|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date
366451|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
366452|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
366453|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular ‘other’ antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date
366454|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
366455|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date
366456|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
366457|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
366458|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular “other” antidepressant use was defined as use other antidepressant aside from Bupropion, TCA, and SSRI for 4 times per week for 3 months at least 12 months before index date
366459|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
366460|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of TCA for 4 times per week for 3 months at least 12 months before index date
366461|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
366462|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
366463|NCT01077596|E12|Reported Event|New Antidepressant Exposure in Prostate Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Controls
366464|NCT01077596|E11|Reported Event|New Antidepressant Exposure in Prostate Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Cases
366465|NCT01077596|E10|Reported Event|New Antidepressant Exposure in Breast Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Controls
366466|NCT01077596|E9|Reported Event|New Antidepressant Exposure in Breast Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Cases
366467|NCT01077596|E8|Reported Event|New Antidepressant Exposure in Uterine Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Controls
366468|NCT01077596|E7|Reported Event|New Antidepressant Exposure in Uterine Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Cases
366469|NCT01077596|E6|Reported Event|New Antidepressant Exposure in Bladder Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Controls
366470|NCT01077596|E5|Reported Event|New Antidepressant Exposure in Bladder Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Cases
366471|NCT01077596|E4|Reported Event|New Antidepressant Exposure in Lung Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Controls
366472|NCT01077596|E3|Reported Event|New Antidepressant Exposure in Lung Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Cases
366473|NCT01077596|E2|Reported Event|New Antidepressant Exposure in Colorectal Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Controls
366474|NCT01077596|E1|Reported Event|New Antidepressant Exposure in Colorectal Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Cases
366475|NCT01077544|B3|Baseline|Total|Total of all reporting groups
366476|NCT01077544|B2|Baseline|Group 2|>= 10 years to <18 years pediatric patients
366477|NCT01077544|B1|Baseline|Group 1|1 year to < 10 years pediatric patients
366478|NCT01077544|P2|Participant Flow|Group 2|>= 10 years to <18 years pediatric patients
366479|NCT01077544|P1|Participant Flow|Group 1|1 year to < 10 years pediatric patients
366480|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
366481|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
366482|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
366483|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
366484|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
366485|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
366486|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
366487|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
366488|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
366489|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
366490|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
366491|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
366492|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
366493|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
366494|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
366495|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
366496|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
366497|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
366498|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
366499|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
366500|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
366501|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
366502|NCT01077544|E2|Reported Event|Group 2|>= 10 years to <18 years pediatric patients
366503|NCT01077544|E1|Reported Event|Group 1|1 year to < 10 years pediatric patients
366504|NCT01077401|B3|Baseline|Total|Total of all reporting groups
366505|NCT01077401|B2|Baseline|Ranibizumab 2.0 mg|"Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.~ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria."
366506|NCT01077401|B1|Baseline|Ranibizumab 0.5mg|"Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.~Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria."
366507|NCT01077401|P2|Participant Flow|Ranibizumab 2.0 mg|"Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.~ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria."
366508|NCT01077401|P1|Participant Flow|Ranibizumab 0.5mg|"Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.~Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria."
366509|NCT01077401|O2|Outcome|Ranibizumab 2.0 mg|"Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.~ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria."
366510|NCT01077401|O1|Outcome|Ranibizumab 0.5mg|"Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.~Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria."
366511|NCT01077401|O2|Outcome|Ranibizumab 2.0 mg|"Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.~ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria."
366611|NCT01077284|B4|Baseline|Total|Total of all reporting groups
366612|NCT01077284|B3|Baseline|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
370639|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
366512|NCT01077401|O1|Outcome|Ranibizumab 0.5mg|"Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.~Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria."
366513|NCT01077401|O2|Outcome|Ranibizumab 2.0 mg|"Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.~ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria."
366514|NCT01077401|O1|Outcome|Ranibizumab 0.5mg|"Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.~Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria."
366515|NCT01077401|E2|Reported Event|Ranibizumab 2.0 mg|"Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.~ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria."
366516|NCT01077401|E1|Reported Event|Ranibizumab 0.5mg|"Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.~Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria."
366517|NCT01077375|B3|Baseline|Total|Total of all reporting groups
366518|NCT01077375|B2|Baseline|Milnacipran|"Double-blind Safety Population: milnacipran treatment assignment, 100 to 200 md/day, twice a day in divided doses, oral administration.~One patient randomized to the milnacipran treatment group did not take at least one dose of double-blind study drug and was therefore not included in the Double-blind Safety Population."
366519|NCT01077375|B1|Baseline|Placebo|Double-blind Safety Population: Placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
366520|NCT01077375|P2|Participant Flow|Milnacipran|Randomized Population: milnacipran treatment assignment, 100 to 200 mg/day, twice a day in divided doses, oral administration.
366521|NCT01077375|P1|Participant Flow|Placebo|Randomized Population: placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
366522|NCT01077375|O2|Outcome|Milnacipran|"Intent-to-treat Population, milnacipran treatment assignment, 100 to 200 mg/day, twice a day, oral administration.~Flexible dosing from 50 mg/day to 200 mg/day was allowed except at a) the initial dosage after randomization had to be 100 mg/day, b) the dose range during week 1 of the randomized double-blind treatment period was 50 to 100 mg/day, and c) patients had to be on at least 100 mg/day at Visit 3 (Week 5)"
366523|NCT01077375|O1|Outcome|Placebo|Intent-to-treat Population, placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
366524|NCT01077375|O2|Outcome|Milnacipran|"Intent-to-treat Population, milnacipran treatment assignment, 100 to 200 mg/day, twice a day, oral administration.~Flexible dosing from 50 mg/day to 200 mg/day was allowed except at a) the initial dosage after randomization had to be 100 mg/day, b) the dose range during week 1 of the randomized double-blind treatment period was 50 to 100 mg/day, and c) patients had to be on at least 100 mg/day at Visit 3 (Week 5)."
366525|NCT01077375|O1|Outcome|Placebo|Intent-to-treat (ITT) Population, placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
366526|NCT01077375|E2|Reported Event|Milnacipran|"Double-blind Safety Population: milnacipran treatment assignment, 100 to 200 mg/day, twice a day, oral administration.~One patient randomized to the milnacipran treatment group did not take at least one dose of double-blind study drug and was therefore not included in the Double-blind Safety Population.~Flexible dosing from 50 mg/day to 200 mg/day was allowed except at a) the initial dosage after randomization had to be 100 mg/day, b) the dose range during week 1 of the randomized double-blind treatment period was 50 to 100 mg/day, and c) patients had to be on at least 100 mg/day at Visit 3 (Week 5)."
366527|NCT01077375|E1|Reported Event|Placebo|Double-blind Safety Population: placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
366528|NCT01077362|B4|Baseline|Total|Total of all reporting groups
366529|NCT01077362|B3|Baseline|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
366530|NCT01077362|B2|Baseline|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
366531|NCT01077362|B1|Baseline|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
366532|NCT01077362|P3|Participant Flow|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
366533|NCT01077362|P2|Participant Flow|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
366613|NCT01077284|B2|Baseline|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
370640|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
366534|NCT01077362|P1|Participant Flow|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
366535|NCT01077362|O4|Outcome|All Ustekinumab Combined|Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
366536|NCT01077362|O3|Outcome|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
366537|NCT01077362|O2|Outcome|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
366538|NCT01077362|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
366539|NCT01077362|O4|Outcome|All Ustekinumab Combined|Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
366540|NCT01077362|O3|Outcome|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
366541|NCT01077362|O2|Outcome|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
366542|NCT01077362|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
366543|NCT01077362|O4|Outcome|All Ustekinumab Combined|Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
366544|NCT01077362|O3|Outcome|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
366545|NCT01077362|O2|Outcome|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
366546|NCT01077362|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
366547|NCT01077362|O4|Outcome|All Ustekinumab Combined|Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
366548|NCT01077362|O3|Outcome|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
366549|NCT01077362|O2|Outcome|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
366550|NCT01077362|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
366551|NCT01077362|O4|Outcome|All Ustekinumab Combined|Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
366552|NCT01077362|O3|Outcome|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
366553|NCT01077362|O2|Outcome|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
366614|NCT01077284|B1|Baseline|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
366615|NCT01077284|P3|Participant Flow|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
366554|NCT01077362|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
366555|NCT01077362|O4|Outcome|All Ustekinumab Combined|Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
366556|NCT01077362|O3|Outcome|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
366557|NCT01077362|O2|Outcome|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
366558|NCT01077362|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
366559|NCT01077362|E7|Reported Event|Ustekinumab 90 mg: Weeks 16-60|Adverse events which occurred during Weeks 16-60 in participants who were randomly assigned to ustekinumab 90 mg at Baseline.
366560|NCT01077362|E6|Reported Event|Ustekinumab 45 mg: Weeks 16-60|Adverse events which occurred during Weeks 16-60 in participants who were randomly assigned to ustekinumab 45 mg at Baseline.
366561|NCT01077362|E5|Reported Event|Placebo -> Ustekinumab 45 mg: Weeks 16-60|Adverse events which occurred (1) during Weeks 16-60 in participants randomly assigned to placebo at Baseline and who early escaped to ustekinumab 45 mg at Week 16 and (2) during Weeks 24-60 in participants randomly assigned to placebo at Baseline and who crossed over to ustekinumab 45 mg at Week 24.
366562|NCT01077362|E4|Reported Event|Placebo: Weeks 16-24|Adverse events which occurred during Weeks 16-24 in participants who were randomly assigned to placebo at Baseline and did not early escape at Week 16.
366563|NCT01077362|E3|Reported Event|Ustekinumab 90 mg: Controlled Period|Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to ustekinumab 90 mg at Baseline.
366564|NCT01077362|E2|Reported Event|Ustekinumab 45 mg: Controlled Period|Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to ustekinumab 45 mg at Baseline.
366565|NCT01077362|E1|Reported Event|Placebo: Controlled Period|Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to placebo at Baseline.
366566|NCT01077323|B4|Baseline|Total|Total of all reporting groups
366567|NCT01077323|B3|Baseline|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
366568|NCT01077323|B2|Baseline|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
366569|NCT01077323|B1|Baseline|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
366570|NCT01077323|P3|Participant Flow|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
366571|NCT01077323|P2|Participant Flow|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
366572|NCT01077323|P1|Participant Flow|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
366573|NCT01077323|O3|Outcome|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
366574|NCT01077323|O2|Outcome|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
366704|NCT01077258|O3|Outcome|Month 6|6 months after inclusion
366575|NCT01077323|O1|Outcome|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
366576|NCT01077323|O3|Outcome|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
366577|NCT01077323|O2|Outcome|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
366578|NCT01077323|O1|Outcome|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
366579|NCT01077323|O3|Outcome|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
366580|NCT01077323|O2|Outcome|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
366581|NCT01077323|O1|Outcome|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
366582|NCT01077323|O3|Outcome|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
366583|NCT01077323|O2|Outcome|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
366584|NCT01077323|O1|Outcome|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
366585|NCT01077323|E3|Reported Event|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
366586|NCT01077323|E2|Reported Event|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
366587|NCT01077323|E1|Reported Event|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
366588|NCT01077310|B3|Baseline|Total|Total of all reporting groups
366589|NCT01077310|B2|Baseline|Placebo|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
366590|NCT01077310|B1|Baseline|Extended-release Naltrexone|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
366591|NCT01077310|P2|Participant Flow|Placebo|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
366592|NCT01077310|P1|Participant Flow|Extended-release Naltrexone|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
366593|NCT01077310|O4|Outcome|Placebo, Received 4-6 Injections|
366594|NCT01077310|O3|Outcome|Extended-release Naltrexone, Received 4-6 Injections|
366595|NCT01077310|O2|Outcome|Placebo, Received 0-3 Injections|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
366596|NCT01077310|O1|Outcome|Extended-release Naltrexone, Received 0-3 Injections|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
366597|NCT01077310|O4|Outcome|Placebo, Received 4-6 Injections|
366598|NCT01077310|O3|Outcome|Extended-release Naltrexone, Received 4-6 Injections|
366599|NCT01077310|O2|Outcome|Placebo, Received 0-3 Injections|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
366600|NCT01077310|O1|Outcome|Extended-release Naltrexone, Received 0-3 Injections|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
366601|NCT01077310|O4|Outcome|Placebo, Received 4-6 Injections|
366602|NCT01077310|O3|Outcome|Extended-release Naltrexone, Received 4-6 Injections|
366603|NCT01077310|O2|Outcome|Placebo, Received 0-3 Injections|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
366604|NCT01077310|O1|Outcome|Extended-release Naltrexone, Received 0-3 Injections|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
366605|NCT01077310|O2|Outcome|Placebo|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
366606|NCT01077310|O1|Outcome|Extended-release Naltrexone|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
366607|NCT01077310|O2|Outcome|Placebo|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
366608|NCT01077310|O1|Outcome|Intramuscular Naltrexone|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
366609|NCT01077310|E2|Reported Event|Placebo|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
366610|NCT01077310|E1|Reported Event|Extended-release Naltrexone|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
366616|NCT01077284|P2|Participant Flow|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
366617|NCT01077284|P1|Participant Flow|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
366618|NCT01077284|O3|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
366619|NCT01077284|O2|Outcome|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
366620|NCT01077284|O1|Outcome|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
366621|NCT01077284|O3|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
366622|NCT01077284|O2|Outcome|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
366623|NCT01077284|O1|Outcome|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
366624|NCT01077284|O3|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
366625|NCT01077284|O2|Outcome|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
366626|NCT01077284|O1|Outcome|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
366627|NCT01077284|O3|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
366628|NCT01077284|O2|Outcome|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
366629|NCT01077284|O1|Outcome|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
366630|NCT01077284|E3|Reported Event|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
366631|NCT01077284|E2|Reported Event|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
366632|NCT01077284|E1|Reported Event|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
366633|NCT01077271|B5|Baseline|Total|Total of all reporting groups
366634|NCT01077271|B4|Baseline|No Matching RSV Season|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
366635|NCT01077271|B3|Baseline|RSV Season 3|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
366636|NCT01077271|B2|Baseline|RSV Season 2|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
366637|NCT01077271|B1|Baseline|RSV Season 1|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
366638|NCT01077271|P1|Participant Flow|Premature Infants 33 - 35 wGA Prophylaxed With Palivizumab|Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with palivizumab
366639|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
366640|NCT01077271|O4|Outcome|No Matching RSV Season (NS)|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
366641|NCT01077271|O3|Outcome|RSV Season 3 (S3)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
366642|NCT01077271|O2|Outcome|RSV Season 2 (S2)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
366643|NCT01077271|O1|Outcome|RSV Season 1 (S1)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
366644|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
366645|NCT01077271|O4|Outcome|No Matching RSV Season (NS)|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
366646|NCT01077271|O3|Outcome|RSV Season 3 (S3)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
366647|NCT01077271|O2|Outcome|RSV Season 2 (S2)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
366648|NCT01077271|O1|Outcome|RSV Season 1 (S1)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
366649|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
366650|NCT01077271|O4|Outcome|No Matching RSV Season (NS)|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
366651|NCT01077271|O3|Outcome|RSV Season 3 (S3)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
366652|NCT01077271|O2|Outcome|RSV Season 2 (S2)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
366653|NCT01077271|O1|Outcome|RSV Season 1 (S1)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
366654|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
366655|NCT01077271|O4|Outcome|No Matching RSV Season (NS)|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
366656|NCT01077271|O3|Outcome|RSV Season 3 (S3)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
366705|NCT01077258|O2|Outcome|Month 3|3 months after inclusion
366706|NCT01077258|O1|Outcome|Month 0|Baseline
366657|NCT01077271|O2|Outcome|RSV Season 2 (S2)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
366658|NCT01077271|O1|Outcome|RSV Season 1 (S1)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
366659|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
366660|NCT01077271|O4|Outcome|No Matching RSV Season (NS)|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
366661|NCT01077271|O3|Outcome|RSV Season 3 (S3)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
366662|NCT01077271|O2|Outcome|RSV Season 2 (S2)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
366663|NCT01077271|O1|Outcome|RSV Season 1 (S1)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
366664|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
366665|NCT01077271|O4|Outcome|No Matching RSV Season|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
366666|NCT01077271|O3|Outcome|RSV Season 3|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
366667|NCT01077271|O2|Outcome|RSV Season 2|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
366668|NCT01077271|O1|Outcome|RSV Season 1|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
366669|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
366670|NCT01077271|O4|Outcome|No Matching RSV Season|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
366671|NCT01077271|O3|Outcome|RSV Season 3|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
366672|NCT01077271|O2|Outcome|RSV Season 2|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
366673|NCT01077271|O1|Outcome|RSV Season 1|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
366674|NCT01077271|E1|Reported Event|Premature Infants 33 - 35 wGA Prophylaxed With Palivizumab|Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with palivizumab
366675|NCT01077258|B1|Baseline|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
366676|NCT01077258|P1|Participant Flow|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
366677|NCT01077258|O7|Outcome|Month 24|24 months after inclusion
366678|NCT01077258|O6|Outcome|Month 18|18 months after inclusion
366679|NCT01077258|O5|Outcome|Month 12|12 months after inclusion
366680|NCT01077258|O4|Outcome|Month 9|9 months after inclusion
366681|NCT01077258|O3|Outcome|Month 6|6 months after inclusion
366682|NCT01077258|O2|Outcome|Month 3|3 months after inclusion
366683|NCT01077258|O1|Outcome|Month 0|Baseline
366684|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
366685|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
366686|NCT01077258|O6|Outcome|Month 24|24 months after inclusion
366687|NCT01077258|O5|Outcome|Month 18|18 months after inclusion
366688|NCT01077258|O4|Outcome|Month 9|9 months after inclusion
366689|NCT01077258|O3|Outcome|Month 6|6 months after inclusion
366690|NCT01077258|O2|Outcome|Month 3|3 months after inclusion
366691|NCT01077258|O1|Outcome|Month 0|Baseline
366692|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
366693|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
366694|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
366695|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
366696|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
366697|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
366698|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
366699|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
366700|NCT01077258|O7|Outcome|Month 24|24 months after inclusion
366701|NCT01077258|O6|Outcome|Month 18|18 months after inclusion
366702|NCT01077258|O5|Outcome|Month 12|12 months after inclusion
366703|NCT01077258|O4|Outcome|Month 9|9 months after inclusion
366707|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
366708|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
366709|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
366710|NCT01077258|E1|Reported Event|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
366711|NCT01077193|B1|Baseline|Gastric Plication Surgery|"Gastric Plication : A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.~The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.~At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure."
366712|NCT01077193|P1|Participant Flow|Gastric Plication Surgery|"Gastric Plication : A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.~The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.~At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure."
366713|NCT01077193|O1|Outcome|Gastric Plication Surgery|"Gastric Plication : A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.~The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.~At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure."
366714|NCT01077193|E1|Reported Event|Gastric Plication Surgery|"Gastric Plication : A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.~The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.~At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure."
366715|NCT01077128|B1|Baseline|Patients With Psoriasis|All eligible patients with psoriasis treated with Adalimumab
366716|NCT01077128|P1|Participant Flow|Patients With Psoriasis|All eligible patients with psoriasis treated with Adalimumab
366717|NCT01077128|O1|Outcome|Patients With Psoriasis|All eligible patients with psoriasis treated with Adalimumab were followed for the long term use and safety of Adalimumab. For more detailed information, please see the Adverse Events section.
366718|NCT01077128|O4|Outcome|EQ-5D VAS- Mean Change From Baseline-Month 12|All eligible patients with psoriasis treated with Adalimumab
366719|NCT01077128|O3|Outcome|EQ-5D VAS- Mean Change From Baseline-Month 8|All eligible patients with psoriasis treated with Adalimumab
366720|NCT01077128|O2|Outcome|EQ-5D VAS- Mean Change From Baseline-Month 4|All eligible patients with psoriasis treated with Adalimumab
366721|NCT01077128|O1|Outcome|EQ-5D VAS- Mean Change From Baseline-Month 1|All eligible patients with psoriasis treated with Adalimumab
366722|NCT01077128|O25|Outcome|EQ5D- Anxiety/Depression- Month 12|All eligible patients with psoriasis treated with Adalimumab
366723|NCT01077128|O24|Outcome|EQ5D- Anxiety/Depression- Month 8|All eligible patients with psoriasis treated with Adalimumab
366724|NCT01077128|O23|Outcome|EQ5D- Anxiety/Depression- Month 4|All eligible patients with psoriasis treated with Adalimumab
366725|NCT01077128|O22|Outcome|EQ5D- Anxiety/Depression- Month 1|All eligible patients with psoriasis treated with Adalimumab
366726|NCT01077128|O21|Outcome|EQ5D- Anxiety/Depression- Baseline|All eligible patients with psoriasis treated with Adalimumab
366727|NCT01077128|O20|Outcome|EQ5D- Pain/Discomfort- Month 12|All eligible patients with psoriasis treated with Adalimumab
366728|NCT01077128|O19|Outcome|EQ5D- Pain/Discomfort- Month 8|All eligible patients with psoriasis treated with Adalimumab
366729|NCT01077128|O18|Outcome|EQ5D- Pain/Discomfort- Month 4|All eligible patients with psoriasis treated with Adalimumab
366730|NCT01077128|O17|Outcome|EQ5D- Pain/Discomfort- Month 1|All eligible patients with psoriasis treated with Adalimumab
366731|NCT01077128|O16|Outcome|EQ5D- Pain/Discomfort- Baseline|All eligible patients with psoriasis treated with Adalimumab
366732|NCT01077128|O15|Outcome|EQ5D- Usual Activities- Month 12|All eligible patients with psoriasis treated with Adalimumab
366733|NCT01077128|O14|Outcome|EQ5D- Usual Activities- Month 8|All eligible patients with psoriasis treated with Adalimumab
366734|NCT01077128|O13|Outcome|EQ5D- Usual Activities- Month 4|All eligible patients with psoriasis treated with Adalimumab
366735|NCT01077128|O12|Outcome|EQ5D- Usual Activities- Month 1|All eligible patients with psoriasis treated with Adalimumab
366736|NCT01077128|O11|Outcome|EQ5D- Usual Activities- Baseline|All eligible patients with psoriasis treated with Adalimumab
366737|NCT01077128|O10|Outcome|EQ5D- Self-care- Month 12|All eligible patients with psoriasis treated with Adalimumab
366738|NCT01077128|O9|Outcome|EQ5D- Self-care- Month 8|All eligible patients with psoriasis treated with Adalimumab
366739|NCT01077128|O8|Outcome|EQ5D- Self-care- Month 4|All eligible patients with psoriasis treated with Adalimumab
366740|NCT01077128|O7|Outcome|EQ5D- Self-care- Month 1|All eligible patients with psoriasis treated with Adalimumab
366741|NCT01077128|O6|Outcome|EQ5D- Self-care- Baseline|All eligible patients with psoriasis treated with Adalimumab
366742|NCT01077128|O5|Outcome|EQ5D- Mobility- Month 12|All eligible patients with psoriasis treated with Adalimumab
366743|NCT01077128|O4|Outcome|EQ5D- Mobility- Month 8|All eligible patients with psoriasis treated with Adalimumab
366744|NCT01077128|O3|Outcome|EQ5D- Mobility- Month 4|All eligible patients with psoriasis treated with Adalimumab
366745|NCT01077128|O2|Outcome|EQ5D- Mobility- Month 1|All eligible patients with psoriasis treated with Adalimumab
366746|NCT01077128|O1|Outcome|EQ5D- Mobility- Baseline|All eligible patients with psoriasis treated with Adalimumab
366747|NCT01077128|O17|Outcome|DLQI Score Change Baseline to Month 12- West Macedonia|All eligible patients with psoriasis treated with Adalimumab
366748|NCT01077128|O16|Outcome|DLQI Score Change Baseline to Month 12- West Greece|All eligible patients with psoriasis treated with Adalimumab
366749|NCT01077128|O15|Outcome|DLQI Score Change Baseline to Month 12- Thessaly|All eligible patients with psoriasis treated with Adalimumab
366750|NCT01077128|O14|Outcome|DLQI Score Change Baseline to Month 12- South Aegean|All eligible patients with psoriasis treated with Adalimumab
366751|NCT01077128|O13|Outcome|DLQI Score Change Baseline to Month 12- Peloponnese|All eligible patients with psoriasis treated with Adalimumab
366752|NCT01077128|O12|Outcome|DLQI Score Change Baseline to Month 12- North Aegean|All eligible patients with psoriasis treated with Adalimumab
366753|NCT01077128|O11|Outcome|DLQI Score Change Baseline to Month 12- Ionian Islands|All eligible patients with psoriasis treated with Adalimumab
366754|NCT01077128|O10|Outcome|DLQI Score Change Baseline to Month 12- Epirus|All eligible patients with psoriasis treated with Adalimumab
366755|NCT01077128|O9|Outcome|DLQI Score Change Baseline to Month 12- East Macedonia/Thrace|All eligible patients with psoriasis treated with Adalimumab
366756|NCT01077128|O8|Outcome|DLQI Score Change Baseline to Month 12- Crete|All eligible patients with psoriasis treated with Adalimumab
366757|NCT01077128|O7|Outcome|DLQI Score Change Baseline to Month 12- Central Macedonia|All eligible patients with psoriasis treated with Adalimumab
366758|NCT01077128|O6|Outcome|DLQI Score Change Baseline to Month 12- Central Greece|All eligible patients with psoriasis treated with Adalimumab
366759|NCT01077128|O5|Outcome|DLQI Score Change Baseline to Month 12- Attica|All eligible patients with psoriasis treated with Adalimumab
366760|NCT01077128|O4|Outcome|DLQI Score Change by PGA Response Group- Month 12|All eligible patients with psoriasis treated with Adalimumab
366761|NCT01077128|O3|Outcome|DLQI Score Change by PGA Response Group- Month 8|All eligible patients with psoriasis treated with Adalimumab
366762|NCT01077128|O2|Outcome|DLQI Score Change by PGA Response Group- Month 4|All eligible patients with psoriasis treated with Adalimumab
366763|NCT01077128|O1|Outcome|DLQI Score Change by PGA Response Group- Month 1|All eligible patients with psoriasis treated with Adalimumab
366764|NCT01077128|O4|Outcome|Patients With Psoriasis- Month 12|All eligible patients with psoriasis treated with Adalimumab
366765|NCT01077128|O3|Outcome|Patients With Psoriasis- Month 8|All eligible patients with psoriasis treated with Adalimumab
366766|NCT01077128|O2|Outcome|Patients With Psoriasis- Month 4|All eligible patients with psoriasis treated with Adalimumab
366767|NCT01077128|O1|Outcome|Patients With Psoriasis- Month 1|All eligible patients with psoriasis treated with Adalimumab
366768|NCT01077128|O4|Outcome|Patients With Psoriasis- Month 12|All eligible patients with psoriasis treated with Adalimumab
366769|NCT01077128|O3|Outcome|Patients With Psoriasis- Month 8|All eligible patients with psoriasis treated with Adalimumab
366770|NCT01077128|O2|Outcome|Patients With Psoriasis- Month 4|All eligible patients with psoriasis treated with Adalimumab
366771|NCT01077128|O1|Outcome|Patients With Psoriasis- Month 1|All eligible patients with psoriasis treated with Adalimumab
366772|NCT01077128|E1|Reported Event|Patients With Psoriasis|All eligible patients with psoriasis treated with Adalimumab
366773|NCT01077076|B1|Baseline|Entire Study Population|
366774|NCT01077076|P6|Participant Flow|Placebo/Prilosec/Zegerid|Participants received Placebo Capsules in the first intervention, Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the second intervention (after the washout period), and Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the third intervention (after the washout period).
366775|NCT01077076|P5|Participant Flow|Placebo/Zegerid/Prilosec|Participants received Placebo Capsules in the first intervention, Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the second intervention (after the washout period), and Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the third intervention (after the washout period).
366776|NCT01077076|P4|Participant Flow|Prilosec/Placebo/Zegerid|Participants received Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the first intervention, Placebo Capsules in the second intervention (after the washout period), and Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the third intervention (after the washout period).
366777|NCT01077076|P3|Participant Flow|Prilosec/Zegerid/Placebo|Participants received Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the first intervention, Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the second intervention (after the washout period), and Placebo Capsules in the third intervention (after the washout period).
366778|NCT01077076|P2|Participant Flow|Zegerid/Placebo/Prilosec|Participants received Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the first intervention, Placebo Capsules in the second intervention (after the washout period), and Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the third intervention (after the washout period).
366779|NCT01077076|P1|Participant Flow|Zegerid/Prilosec/Placebo|Participants received Zegerid over-the-counter (OTC) Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the first intervention, Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the second intervention (after the washout period), and Placebo Capsules in the third intervention (after the washout period).
366782|NCT01077076|O1|Outcome|Zegerid OTC Capsules|20 mg omeprazole and 1100 mg sodium bicarbonate
366783|NCT01077076|E3|Reported Event|Placebo Capsules|
366784|NCT01077076|E2|Reported Event|Prilosec OTC Tablets|20 mg-equivalent omeprazole
366785|NCT01077076|E1|Reported Event|Zegerid OTC Capsules|20 mg omeprazole and 1100 mg sodium bicarbonate
366786|NCT01077063|B3|Baseline|Total|Total of all reporting groups
366787|NCT01077063|B2|Baseline|Pleurx Catheter|"a catheter drainage system the subject uses himself/herself.~Pleurx catheter: take home catheter drainage system that the subject uses himself/herself as needed."
366788|NCT01077063|B1|Baseline|Paracentesis|"cutting and draining procedure for malignant ascites~paracentesis: surgical drainage of malignant ascites"
366789|NCT01077063|P2|Participant Flow|Paracentesis|"cutting and draining procedure for malignant ascites~paracentesis: surgical drainage of malignant ascites"
366790|NCT01077063|P1|Participant Flow|Pleurx Catheter|"a catheter drainage system the subject uses himself/herself.~Pleurx catheter: take home catheter drainage system that the subject uses himself/herself as needed."
366791|NCT01077063|O2|Outcome|Pleurx Catheter|"a catheter drainage system the subject uses himself/herself.~Pleurx catheter: take home catheter drainage system that the subject uses himself/herself as needed."
366792|NCT01077063|O1|Outcome|Paracentesis|"cutting and draining procedure for malignant ascites~paracentesis: surgical drainage of malignant ascites"
366793|NCT01077063|E2|Reported Event|Pleurx Catheter|"a catheter drainage system the subject uses himself/herself.~Pleurx catheter: take home catheter drainage system that the subject uses himself/herself as needed."
366794|NCT01077063|E1|Reported Event|Paracentesis|"cutting and draining procedure for malignant ascites~paracentesis: surgical drainage of malignant ascites"
366795|NCT01077050|B1|Baseline|Biopsied Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
366796|NCT01077050|P1|Participant Flow|Only One Arm in the Study, Thus Not Applicable.|
366797|NCT01077050|O1|Outcome|Biopsied Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
366798|NCT01077050|E1|Reported Event|Biopsied Skin Lesions|"Any adverse advent that occured on a skin/lesion site for whom there had been any contact between the subject's skin and investigational device (SciBase III).~Note that multiple adverse event occured on some subjects. In total 36 Adverse Events were reported on 28 subjects."
366799|NCT01077024|B3|Baseline|Total|Total of all reporting groups
366800|NCT01077024|B2|Baseline|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
366801|NCT01077024|B1|Baseline|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
366802|NCT01077024|P2|Participant Flow|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
366803|NCT01077024|P1|Participant Flow|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
366804|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
366805|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
366806|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
366807|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
366808|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
366809|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
366810|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
366811|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
366812|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
366871|NCT01076686|E4|Reported Event|High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
366872|NCT01076686|E3|Reported Event|Bupivacaine|Single dose of study drug was injected locally into the breast pockets
370641|NCT01067976|O1|Outcome|CMRM vs UMRM|
366813|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
366814|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
366815|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
366816|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
366817|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
366818|NCT01077024|E2|Reported Event|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
366819|NCT01077024|E1|Reported Event|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
366820|NCT01076985|B1|Baseline|Lopinavir/Ritonavir Group|All pregnant women in this noninterventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
366821|NCT01076985|P1|Participant Flow|Lopinavir/Ritonavir Group|All pregnant women in this noninterventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
366822|NCT01076985|O2|Outcome|Infants|Infants from live births of the pregnant women who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection and participated in this noninterventional, post-marketing observational study.
366823|NCT01076985|O1|Outcome|Lopinavir/Ritonavir|All pregnant women in this noninterventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
366824|NCT01076985|E2|Reported Event|Infants|Infants from live births of the pregnant women who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection who participated in this noninterventional, post-marketing observational study.
366825|NCT01076985|E1|Reported Event|Lopinavir/Ritonavir Group|All pregnant women in this noninterventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
366826|NCT01076972|B1|Baseline|Lopinavir/Ritonavir Group|All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
366827|NCT01076972|P1|Participant Flow|Lopinavir/Ritonavir Group|All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
366828|NCT01076972|O7|Outcome|Lopinavir/Ritonavir: Baseline Category Unknown|The subgroup of participants whose CDC classification at Baseline (prior to treatment with lopinavir/ritonavir) was unknown.
366829|NCT01076972|O6|Outcome|Lopinavir/Ritonavir: Baseline Category P-2|The subgroup of participants who were classified as CDC Category P-2 at Baseline (prior to treatment with lopinavir/ritonavir).
366830|NCT01076972|O5|Outcome|Lopinavir/Ritonavir: Baseline Category P-1|The subgroup of participants who were classified as CDC Category P-1 at Baseline (prior to treatment with lopinavir/ritonavir).
366831|NCT01076972|O4|Outcome|Lopinavir/Ritonavir: Baseline Category P-0|The subgroup of participants who were classified as CDC Category P-0 at Baseline (prior to treatment with lopinavir/ritonavir).
366832|NCT01076972|O3|Outcome|Lopinavir/Ritonavir: Baseline Category C|The subgroup of patients who were classified as CDC Category C at Baseline (prior to treatment with lopinavir/ritonavir).
366833|NCT01076972|O2|Outcome|Lopinavir/Ritonavir: Baseline Category B|The subgroup of participants who were classified as CDC Category B at Baseline (prior to treatment with lopinavir/ritonavir).
366834|NCT01076972|O1|Outcome|Lopinavir/Ritonavir: Baseline Category A|The subgroup of patients who were classified as CDC Category A at Baseline (prior to treatment with lopinavir/ritonavir).
366835|NCT01076972|O2|Outcome|Lopinavir/Ritonavir: Treatment-experienced|The subgroup of patients who have received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 418 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.
366836|NCT01076972|O1|Outcome|Lopinavir/Ritonavir: Treatment-Naive|The subgroup of patients who had not received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 416 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.
366873|NCT01076686|E2|Reported Event|Bupivacaine and High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
366874|NCT01076686|E1|Reported Event|Bupivacaine and Low Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
366837|NCT01076972|O2|Outcome|Lopinavir/Ritonavir: Treatment-Experienced|The subgroup of patients who have received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 420 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.
366838|NCT01076972|O1|Outcome|Lopinavir/Ritonavir: Treatment-Naive|The subgroup of patients who had not received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 416 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.
366839|NCT01076972|O1|Outcome|Lopinavir/Ritonavir Group|All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
366840|NCT01076972|E1|Reported Event|Lopinavir/Ritonavir Group|All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
366841|NCT01076959|B1|Baseline|Humira|Patients who received Humira for 24 weeks during the PMDA review period.
366842|NCT01076959|P1|Participant Flow|Humira|Patients who received Humira for 24 weeks during the PMDA review period.
366843|NCT01076959|O4|Outcome|Effective Rate-Sum of Patients With Good and Moderate Response|Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =>0.6) at Week 24. All variables may not have been tested; therefore, a patient may not have been included.
366844|NCT01076959|O3|Outcome|Humira - No Response|Patients who received Humira during the PMDA review period and had no response to DAS 28 (improvement < 0.6) at Week 24. All variables may not have been tested; therefore, a patient may not have been included.
366845|NCT01076959|O2|Outcome|Humira - Moderate Response|Patients who received Humira during the PMDA review period and had a moderate response to DAS 28 (improvement 0.6 to 1.2) at Week 24. All variables may not have been tested; therefore, a patient may not have been included.
366846|NCT01076959|O1|Outcome|Humira - Good Response|Patients who received Humira during the PMDA review period and had a good response to DAS 28 (improvement > 1.2) at Week 4.at Week 24. All variables may not have been tested; therefore, a patient may not have been included.
366847|NCT01076959|O4|Outcome|Effective Rate-Sum of Patients With Good or Moderate Response|Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =>0.6) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.
366848|NCT01076959|O3|Outcome|Humira - No Response|Patients who received Humira during the PMDA review period and had no response to DAS 28 (improvement < 0.6) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.
366849|NCT01076959|O2|Outcome|Humira - Moderate Response|Patients who received Humira during the PMDA review period and had a moderate response to DAS 28 (improvement 0.6 to 1.2) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.
366850|NCT01076959|O1|Outcome|Humira - Good Response|Patients who received Humira during the PMDA review period and had a good response to DAS 28 (improvement > 1.2) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.
366851|NCT01076959|O4|Outcome|Effective Rate-Sum of Patients With Good or Moderate Response|Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =>0.6) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
366852|NCT01076959|O3|Outcome|Humira - No Response|Patients who received Humira during the PMDA review period and had no response according to DAS 28 (improvement <0.6) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
366853|NCT01076959|O2|Outcome|Humira - Moderate Response|Patients who received Humira during the PMDA review period and had a moderate response according to DAS 28 (improvement 0.6 to 1.2) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
366854|NCT01076959|O1|Outcome|Humira - Good Response|Patients who received Humira during the PMDA review period and had a good response according to DAS 28 (improvement > 1.2) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
366855|NCT01076959|O1|Outcome|Physician Response Rating|The full analysis set was used to determine the physicians' overall response rating.
366856|NCT01076959|O1|Outcome|Humira|Patients who received Humira for 24 weeks during the PMDA review period.
366857|NCT01076959|E1|Reported Event|Humira|Patients who received Humira for 24 weeks during the PMDA review period.
366858|NCT01076686|B5|Baseline|Total|Total of all reporting groups
366859|NCT01076686|B4|Baseline|High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
366860|NCT01076686|B3|Baseline|Bupivacaine|Single dose of study drug was injected locally into the breast pockets
366861|NCT01076686|B2|Baseline|Bupivacaine and High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
366862|NCT01076686|B1|Baseline|Bupivacaine and Low Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
366863|NCT01076686|P4|Participant Flow|High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
366864|NCT01076686|P3|Participant Flow|Bupivacaine|Single dose of study drug was injected locally into the breast pockets
366865|NCT01076686|P2|Participant Flow|Bupivacaine and High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
366866|NCT01076686|P1|Participant Flow|Bupivacaine and Low Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
366867|NCT01076686|O4|Outcome|High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
366868|NCT01076686|O3|Outcome|Bupivacaine|Single dose of study drug was injected locally into the breast pockets
366869|NCT01076686|O2|Outcome|Bupivacaine and High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
366870|NCT01076686|O1|Outcome|Bupivacaine and Low Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
366876|NCT01076647|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
366877|NCT01076647|B1|Baseline|IDeg 3TW|Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
366878|NCT01076647|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
366879|NCT01076647|P1|Participant Flow|IDeg 3TW|Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
366880|NCT01076647|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
366881|NCT01076647|O1|Outcome|IDeg 3TW|Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
366882|NCT01076647|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
366883|NCT01076647|O1|Outcome|IDeg 3TW|Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
366884|NCT01076647|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
366885|NCT01076647|E1|Reported Event|IDeg 3TW|Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
366886|NCT01076504|B1|Baseline|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
366887|NCT01076504|P1|Participant Flow|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
366888|NCT01076504|O1|Outcome|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
366889|NCT01076504|O1|Outcome|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
366890|NCT01076504|O1|Outcome|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
366891|NCT01076504|O1|Outcome|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
366892|NCT01076504|O1|Outcome|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
366893|NCT01076504|E1|Reported Event|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
366894|NCT01076452|B3|Baseline|Total|Total of all reporting groups
366895|NCT01076452|B2|Baseline|Arm 2|"GPi (Globus Pallidus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
366896|NCT01076452|B1|Baseline|Arm 1|"STN (Subthalamic Nucleus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
366897|NCT01076452|P2|Participant Flow|Arm 2|"GPi (Globus Pallidus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
366898|NCT01076452|P1|Participant Flow|Arm 1|"STN (Subthalamic Nucleus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
366899|NCT01076452|O2|Outcome|GPi (Globus Pallidus)|"GPi (Globus Pallidus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
366900|NCT01076452|O1|Outcome|STN (Subthalamic Nucleus)|"STN (Subthalamic Nucleus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
366901|NCT01076452|O2|Outcome|GPi (Globus Pallidus)|"GPi (Globus Pallidus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
366902|NCT01076452|O1|Outcome|STN (Subthalamic Nucleus)|"STN (Subthalamic Nucleus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
366903|NCT01076452|O2|Outcome|GPi (Globus Pallidus)|"GPi (Globus Pallidus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
366904|NCT01076452|O1|Outcome|STN (Subthalamic Nucleus)|"STN (Subthalamic Nucleus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
367032|NCT01076088|B5|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
366905|NCT01076452|O2|Outcome|GPi (Globus Pallidus)|"GPi (Globus Pallidus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
366906|NCT01076452|O1|Outcome|STN (Subthalamic Nucleus)|"STN (Subthalamic Nucleus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
366907|NCT01076452|E2|Reported Event|Arm 2|"GPi (Globus Pallidus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
366908|NCT01076452|E1|Reported Event|Arm 1|"STN (Subthalamic Nucleus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
366909|NCT01076400|B1|Baseline|Part 1: MK-1775 + Topotecan/Cisplatin|Part 1: MK-1775 capsules were administered at 50 mg twice daily on Days 1-4, and once on Day 5 for a total of nine doses per cycle. Each cycle was 21 days. Topotecan was administered at a dosage of 0.75 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1-3 of each cycle. Cisplatin was administered at a dosage of 50 mg/m^2 by IV infusion over 30 minutes on Day 1 of each cycle. Only a single dose of MK-1775 was administered during Part 1.
366910|NCT01076400|P3|Participant Flow|Part 2: Placebo to MK-1775 + Topotecan/Cisplatin|Part 2: Placebo to MK-1775 capsules will be administered twice daily for a total of nine doses on Days 1-5 of a 21-day cycle. Topotecan will be administered at a dosage of 0.75 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1-3. Cisplatin will be administered at a dosage of 50 mg/m^2 by IV infusion over 30 minutes on Day 1.
366911|NCT01076400|P2|Participant Flow|Part 2: MK-1775 + Topotecan/Cisplatin|Part 2: MK-1775 capsules will be administered at the dose determined in Part 1 twice daily for a total of nine doses on Days 1-5 of a 21-day cycle. Topotecan will be administered at a dosage of 0.75 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1-3. Cisplatin will be administered at a dosage of 50 mg/m^2 by IV infusion over 30 minutes on Day 1.
366912|NCT01076400|P1|Participant Flow|Part 1: MK-1775 + Topotecan/Cisplatin|Part 1: MK-1775 capsules were administered at 50 mg twice daily on Days 1-4, and once on Day 5 for a total of nine doses per cycle. Each cycle was 21 days. Topotecan was administered at a dosage of 0.75 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1-3 of each cycle. Cisplatin was administered at a dosage of 50 mg/m^2 by IV infusion over 30 minutes on Day 1 of each cycle. Only a single dose of MK-1775 was administered during Part 1.
366913|NCT01076400|O1|Outcome|Part 1: MK-1775 + Topotecan/Cisplatin|Part 1: MK-1775 capsules were administered at 50 mg twice daily on Days 1-4, and once on Day 5 for a total of nine doses per cycle. Each cycle was 21 days. Topotecan was administered at a dosage of 0.75 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1-3 of each cycle. Cisplatin was administered at a dosage of 50 mg/m^2 by IV infusion over 30 minutes on Day 1 of each cycle. Only a single dose of MK-1775 was administered during Part 1.
366914|NCT01076400|O1|Outcome|Part 1: MK-1775 + Topotecan/Cisplatin|Part 1: MK-1775 capsules were administered at 50 mg twice daily on Days 1-4, and once on Day 5 for a total of nine doses per cycle. Each cycle was 21 days. Topotecan was administered at a dosage of 0.75 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1-3 of each cycle. Cisplatin was administered at a dosage of 50 mg/m^2 by IV infusion over 30 minutes on Day 1 of each cycle. Only a single dose of MK-1775 was administered during Part 1.
366915|NCT01076400|O1|Outcome|Part 1: MK-1775 + Topotecan/Cisplatin|Part 1: MK-1775 capsules were administered at 50 mg twice daily on Days 1-4, and once on Day 5 for a total of nine doses per cycle. Each cycle was 21 days. Topotecan was administered at a dosage of 0.75 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1-3 of each cycle. Cisplatin was administered at a dosage of 50 mg/m^2 by IV infusion over 30 minutes on Day 1 of each cycle. Only a single dose of MK-1775 was administered during Part 1.
366916|NCT01076400|E1|Reported Event|Part 1: MK-1775 + Topotecan/Cisplatin|Part 1: MK-1775 capsules were administered at 50 mg twice daily on Days 1-4, and once on Day 5 for a total of nine doses per cycle. Each cycle was 21 days. Topotecan was administered at a dosage of 0.75 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1-3 of each cycle. Cisplatin was administered at a dosage of 50 mg/m^2 by IV infusion over 30 minutes on Day 1 of each cycle. Only a single dose of MK-1775 was administered during Part 1.
366917|NCT01076361|B1|Baseline|All Enrolled Patients|All patients who were enrolled and implanted with a Model 4968 Lead
366918|NCT01076361|P1|Participant Flow|Model 4968 Leads|A total of 631 leads were implanted in 370 patients. 22 leads in 21 patients were excluded from analysis.
366919|NCT01076361|O1|Outcome|Model 4968 Lead Survival Probability|Model 4968 is steroid-eluting bipolar epicardial pacing lead. Participants implanted with Model 4968 lead their data will be obtained for long-term safety and lead events, includes the survival probability for the Model 4968.
366920|NCT01076361|E1|Reported Event|Model 4968 Participants|All Model 4968 participants in the analysis cohort
366921|NCT01076348|B1|Baseline|Medtronic 4965 Subjects|Single arm registry of Model 4965 implanted patients
366922|NCT01076348|P1|Participant Flow|Medtronic 4965 Subjects|Single arm registry of Model 4965 implanted patients
366923|NCT01076348|O1|Outcome|Medtronic 4965 Epicardial Lead|Subjects who were implanted with at least 1 model 4965 lead.
366924|NCT01076348|E1|Reported Event|Medtronic 4965 Subjects|Single arm registry of Model 4965 implanted patients
366925|NCT01076335|B1|Baseline|Neoadjuvant Hormones + Docetaxel|One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy
366926|NCT01076335|P1|Participant Flow|Neoadjuvant Hormones + Docetaxel|One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy
366927|NCT01076335|O1|Outcome|Neoadjuvant Hormones + Docetaxel|One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy
366928|NCT01076335|E1|Reported Event|Neoadjuvant Hormones + Docetaxel|One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy
366929|NCT01076296|B1|Baseline|Total for All Groups Assessed|Subjects assessed for LV function using both VScan and a clinical examination.
366930|NCT01076296|P8|Participant Flow|No Heart Valve Disease|Subjects assessed for HVD with both VScan and a clinical examination noting no presence of HVD.
366931|NCT01076296|P7|Participant Flow|Heart Valve Disease|Subjects assessed for HVD with both VScan and a clinical examination noting the presence of HVD.
366932|NCT01076296|P6|Participant Flow|No Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting no presence of pulmonary hypertension.
366933|NCT01076296|P5|Participant Flow|Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting the presence of pulmonary hypertension.
366934|NCT01076296|P4|Participant Flow|Normal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality.
366935|NCT01076296|P3|Participant Flow|Abnormal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality.
366936|NCT01076296|P2|Participant Flow|Normal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting no abnormality.
366937|NCT01076296|P1|Participant Flow|Abnormal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting an abnormality.
366938|NCT01076296|O8|Outcome|No Heart Valve Disease|Subjects assessed for Heart Valve Disease function with both VScan and a clinical examination noting no presence of HVD.
366939|NCT01076296|O7|Outcome|Heart Valve Disease|Subjects assessed for Heart Valve Disease function with both VScan and a clinical examination noting the presence of HVD.
366940|NCT01076296|O6|Outcome|No Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension function with both VScan and a clinical examination noting the no presence of pulmonary hypertension.
366941|NCT01076296|O5|Outcome|Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension function with both VScan and a clinical examination noting the presence of pulmonary hypertension.
366942|NCT01076296|O4|Outcome|Normal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality.
366943|NCT01076296|O3|Outcome|Abnormal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality.
366944|NCT01076296|O2|Outcome|Normal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting no abnormality.
366945|NCT01076296|O1|Outcome|Abnormal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting an abnormality.
366946|NCT01076296|E8|Reported Event|No Heart Valve Disease|Subjects assessed for HVD with both VScan and a clinical examination noting no presence of HVD.
366947|NCT01076296|E7|Reported Event|Heart Valve Disease|Subjects assessed for HVD with both VScan and a clinical examination noting the presence of HVD.
366948|NCT01076296|E6|Reported Event|No Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting no presence of pulmonary hypertension.
366949|NCT01076296|E5|Reported Event|Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting the presence of pulmonary hypertension.
366950|NCT01076296|E4|Reported Event|Normal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality.
366951|NCT01076296|E3|Reported Event|Abnormal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality.
366952|NCT01076296|E2|Reported Event|Normal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting no abnormality.
366953|NCT01076296|E1|Reported Event|Abnormal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting an abnormality.
366954|NCT01076283|B3|Baseline|Total|Total of all reporting groups
366955|NCT01076283|B2|Baseline|Cyproheptadine|Cyproheptadine 2 mg t.i.d. for 8-10 days
366956|NCT01076283|B1|Baseline|Baclofen|Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
366957|NCT01076283|P2|Participant Flow|Cyproheptadine|Cyproheptadine 2 mg t.i.d. for 8-10 days
366958|NCT01076283|P1|Participant Flow|Baclofen|Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
366959|NCT01076283|O2|Outcome|Cyproheptadine|Cyproheptadine 2 mg t.i.d. for 8-10 days
366960|NCT01076283|O1|Outcome|Baclofen|Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
366961|NCT01076283|O2|Outcome|Cyproheptadine|Cyproheptadine 2 mg t.i.d. for 8-10 days
366962|NCT01076283|O1|Outcome|Baclofen|Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
366963|NCT01076283|E2|Reported Event|Cyproheptadine|Cyproheptadine 2 mg t.i.d. for 8-10 days
366964|NCT01076283|E1|Reported Event|Baclofen|Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
366965|NCT01076270|B1|Baseline|Filgrastim and Plerixafor for PBSC Mobilization|"Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.~After completion of study treatment, donors are followed up 1 day after the last stem cell donation.~plerixafor: Given SC~filgrastim: Given SC~peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells~allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells"
366966|NCT01076270|P1|Participant Flow|Filgrastim and Plerixafor for PBSC Mobilization|"Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.~After completion of study treatment, donors are followed up 1 day after the last stem cell donation.~plerixafor: Given SC~filgrastim: Given SC~peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells~allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells"
367033|NCT01076088|B4|Baseline|Metformin 850|Metformin 850 mg twice daily
367034|NCT01076088|B3|Baseline|Metformin 500 mg|Metformin 500 mg twice daily
366967|NCT01076270|O1|Outcome|Filgrastim and Plerixafor for PBSC Mobilization|"Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.~After completion of study treatment, donors are followed up 1 day after the last stem cell donation.~plerixafor: Given SC~filgrastim: Given SC~peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells~allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells"
366968|NCT01076270|O1|Outcome|Filgrastim and Plerixafor for PBSC Mobilization|"Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.~After completion of study treatment, donors are followed up 1 day after the last stem cell donation.~plerixafor: Given SC~filgrastim: Given SC~peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells~allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells"
366969|NCT01076270|E1|Reported Event|Filgrastim and Plerixafor for PBSC Mobilization|"Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.~After completion of study treatment, donors are followed up 1 day after the last stem cell donation.~plerixafor: Given SC~filgrastim: Given SC~peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells~allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells"
366970|NCT01076244|B1|Baseline|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
366971|NCT01076244|P1|Participant Flow|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
366972|NCT01076244|O1|Outcome|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
366973|NCT01076244|O1|Outcome|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
366974|NCT01076244|O1|Outcome|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
366975|NCT01076244|O1|Outcome|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
366976|NCT01076244|E1|Reported Event|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
366977|NCT01076192|B1|Baseline|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
366978|NCT01076192|P1|Participant Flow|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
366979|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with adalimumab in routine clinical practice
366980|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
366981|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
366982|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
366983|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
366984|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
366985|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
366986|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
366987|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
366988|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
366989|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
366990|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
366991|NCT01076192|E1|Reported Event|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
366992|NCT01076179|B1|Baseline|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
366993|NCT01076179|P1|Participant Flow|HIV-infected Participants|Human immunodeficiency virus (HIV)-infected participants on Kaletra and integrase inhibitors (INIs) or non nucleoside reverse transcriptase inhibitors NNRTIs) or C-C chemokine receptor type 5 (CCR5) antagonists
366994|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and integrase inhibitors or non nucleoside reverse transcriptase inhibitors or CCR5 antagonists
366995|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and integrase inhibitors or non nucleoside reverse transcriptase inhibitors or CCR5 antagonists
366996|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
366997|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
366998|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
366999|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
367000|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
367001|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
367002|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
367003|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
367004|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
367005|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
367006|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
367007|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
367008|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
367009|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
367010|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
367011|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
367012|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
367013|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
367014|NCT01076179|E1|Reported Event|HIV-infected Participants|HIV-infected participants on Kaletra and integrase inhibitors or non nucleoside reverse transcriptase inhibitors or CCR5 antagonists
367015|NCT01076166|B1|Baseline|Klacid Granules (Total)|The per-protocol population (308 participants) of male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information.
367016|NCT01076166|P1|Participant Flow|Klacid Granules (Total)|Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information.
367017|NCT01076166|O1|Outcome|Klacid Granules (Total)|Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information.
367018|NCT01076166|O3|Outcome|Klacid Granules (Pneumonia, Recovered)|Participants in the recovered population who had a diagnosis of pneumonia at study entry.
367019|NCT01076166|O2|Outcome|Klacid Granules (Bronchitis, Recovered)|Participants in the recovered population who had a diagnosis of bronchitis at study entry.
367020|NCT01076166|O1|Outcome|Klacid Granules (Total Number Recovered)|Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information who were in the recovered population.
367021|NCT01076166|E1|Reported Event|Klacid Granules (Total)|Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information.
367022|NCT01076153|B1|Baseline|Klacid MR|The per-protocol population (694 participants) of male or female Thai adults with upper and/or lower respiratory tract infections on Klacid MR.
367023|NCT01076153|P1|Participant Flow|Klacid MR|Male or female Thai adults with upper and/or lower respiratory tract infections taking Klacid (clarithromycin) modified release (MR) 500 mg according to the Prescribing Information.
367024|NCT01076153|O1|Outcome|Klacid MR|Male or female Thai adults with upper and/or lower respiratory tract infections taking Klacid (clarithromycin) modified release (MR) 500 mg according to the Prescribing Information.
367025|NCT01076153|O4|Outcome|Klacid MR (URTI and LRTI, Recovered)|Participants in the recovered population who had a diagnosis of both upper and lower respiratory tract infections at study entry.
367026|NCT01076153|O3|Outcome|Klacid MR (LRTI, Recovered)|Participants in the recovered population who had a diagnosis of lower respiratory tract infection (LRTI) at study entry.
367027|NCT01076153|O2|Outcome|Klacid MR (URTI, Recovered)|Participants in the recovered population who had a diagnosis of upper respiratory tract infection (URTI) at study entry.
367028|NCT01076153|O1|Outcome|Klacid MR (Total Number Recovered)|Male or female Thai adults with upper and/or lower respiratory tract infections on Klacid MR who were in the recovered population.
367029|NCT01076153|E1|Reported Event|Klacid MR|Male or female Thai adults with upper and/or lower respiratory tract infections taking Klacid (clarithromycin) modified release (MR) 500 mg according to the Prescribing Information.
367030|NCT01076088|B7|Baseline|Total|Total of all reporting groups
367031|NCT01076088|B6|Baseline|Placebo|Matching placebo to sitagliptin and/or metformin. Population includes 1 participant who did not receive any study medication.
367035|NCT01076088|B2|Baseline|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
367036|NCT01076088|B1|Baseline|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
367037|NCT01076088|P6|Participant Flow|Placebo|Matching placebo to sitagliptin and/or metformin. Population includes 1 participant who did not receive any study medication.
367038|NCT01076088|P5|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
367039|NCT01076088|P4|Participant Flow|Metformin 850|Metformin 850 mg twice daily
367040|NCT01076088|P3|Participant Flow|Metformin 500 mg|Metformin 500 mg twice daily
367041|NCT01076088|P2|Participant Flow|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
367042|NCT01076088|P1|Participant Flow|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
367043|NCT01076088|O6|Outcome|Placebo|Matching placebo to sitagliptin and/or metformin
367044|NCT01076088|O5|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
367045|NCT01076088|O4|Outcome|Metformin 850|Metformin 850 mg twice daily
367046|NCT01076088|O3|Outcome|Metformin 500 mg|Metformin 500 mg twice daily
367047|NCT01076088|O2|Outcome|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
367048|NCT01076088|O1|Outcome|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
367049|NCT01076088|O6|Outcome|Placebo|Matching placebo to sitagliptin and/or metformin
367050|NCT01076088|O5|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
367051|NCT01076088|O4|Outcome|Metformin 850|Metformin 850 mg twice daily
367052|NCT01076088|O3|Outcome|Metformin 500 mg|Metformin 500 mg twice daily
367053|NCT01076088|O2|Outcome|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
367054|NCT01076088|O1|Outcome|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
367055|NCT01076088|O6|Outcome|Placebo|Matching placebo to sitagliptin and/or metformin
367056|NCT01076088|O5|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
367057|NCT01076088|O4|Outcome|Metformin 850 mg|Metformin 850 mg twice daily
367058|NCT01076088|O3|Outcome|Metformin 500 mg|Metformin 500 mg twice daily
367059|NCT01076088|O2|Outcome|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
367060|NCT01076088|O1|Outcome|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
367061|NCT01076088|E6|Reported Event|Placebo|Matching placebo to sitagliptin and/or metformin. Population excludes 1 participant who did not receive any study medication.
367062|NCT01076088|E5|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
367063|NCT01076088|E4|Reported Event|Metformin 850|Metformin 850 mg twice daily
367064|NCT01076088|E3|Reported Event|Metformin 500 mg|Metformin 500 mg twice daily
367065|NCT01076088|E2|Reported Event|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
367066|NCT01076088|E1|Reported Event|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
367067|NCT01076075|B3|Baseline|Total|Total of all reporting groups
367068|NCT01076075|B2|Baseline|Placebo/Pioglitazone|Phase A (Weeks 0-24): Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg
367069|NCT01076075|B1|Baseline|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone
367070|NCT01076075|P2|Participant Flow|Placebo/Pioglitazone|Phase A (Weeks 0-24): Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg
367071|NCT01076075|P1|Participant Flow|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone
367072|NCT01076075|O2|Outcome|Placebo/Pioglitazone|Phase A (Weeks 0-24: Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg
367073|NCT01076075|O1|Outcome|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone
367074|NCT01076075|O2|Outcome|Placebo/Pioglitazone|Phase A (Weeks 0-24: Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg
367075|NCT01076075|O1|Outcome|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone
367076|NCT01076075|O2|Outcome|Placebo/Pioglitazone|Phase A (Week 0-24): Placebo to Sitagliptin 100 mg
367077|NCT01076075|O1|Outcome|Sitagliptin|Phase A (Week 0-24): Sitagliptin 100 mg
367078|NCT01076075|O2|Outcome|Placebo/Pioglitazone|Phase A (Week 0-24): Placebo to Sitagliptin 100 mg
367079|NCT01076075|O1|Outcome|Sitagliptin|Phase A (Week 0-24): Sitagliptin 100 mg
367080|NCT01076075|O2|Outcome|Placebo/Pioglitazone|Phase A (Week 0-24): Placebo to Sitagliptin 100 mg
367081|NCT01076075|O1|Outcome|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg
367082|NCT01076075|E2|Reported Event|Placebo/Pioglitazone|Phase A (Weeks 0-24): Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg
367083|NCT01076075|E1|Reported Event|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone
367084|NCT01076036|B1|Baseline|Investigational|CorPath® 200 System
367085|NCT01076036|P1|Participant Flow|Group 1|Group 1 was treated using the CorPath device.
367086|NCT01076036|O1|Outcome|Investigational|CorPath® 200 System
367087|NCT01076036|O1|Outcome|Investigational|CorPath® 200 System
367088|NCT01076036|E1|Reported Event|Investigational|CorPath® 200 System
367089|NCT01075984|B6|Baseline|Total|Total of all reporting groups
367090|NCT01075984|B5|Baseline|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
370642|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
367091|NCT01075984|B4|Baseline|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
367092|NCT01075984|B3|Baseline|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
367093|NCT01075984|B2|Baseline|Placebo IV Single Dose (Cohort 0)|Placebo IV single dose on Day 1, followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
367094|NCT01075984|B1|Baseline|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
367095|NCT01075984|P5|Participant Flow|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
367096|NCT01075984|P4|Participant Flow|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
367097|NCT01075984|P3|Participant Flow|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
367098|NCT01075984|P2|Participant Flow|Placebo IV Single Dose (Cohort 0)|Placebo IV single dose on Day 1, followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
367099|NCT01075984|P1|Participant Flow|Posaconazole (POS) 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
367100|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
367101|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
367102|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
367103|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
367104|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
367105|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
367106|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
367107|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
367108|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
367109|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
367110|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
367111|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
367112|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
367113|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
367114|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
367115|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
367116|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
367117|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
367118|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
370643|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
367119|NCT01075984|O2|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
367120|NCT01075984|O1|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
367121|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
367122|NCT01075984|O2|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
367123|NCT01075984|O1|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
367124|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
367125|NCT01075984|O2|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
367126|NCT01075984|O1|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
367127|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
367128|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
367129|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
367130|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
367131|NCT01075984|O2|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
367132|NCT01075984|O1|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
367133|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
367134|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
367135|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
367136|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
367137|NCT01075984|O2|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
367138|NCT01075984|O1|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
367139|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
367140|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
367141|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
367142|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
367143|NCT01075984|O2|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
367144|NCT01075984|O1|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
367145|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
367146|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
367147|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
367148|NCT01075984|E4|Reported Event|POS 300 mg IV BID (Cohort 2 and 3)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2); POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
367149|NCT01075984|E3|Reported Event|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
367150|NCT01075984|E2|Reported Event|Placebo IV Single Dose (Cohort 0)|Placebo IV single dose on Day 1, followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
367151|NCT01075984|E1|Reported Event|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
367152|NCT01075971|B1|Baseline|Buprenorphine Hydrochloride|8 or 16 mg daily for 5 days; marketed sublingual tablet on Days 1 and 2, fast dissolving tablet (FDT) on Days 3, 4, and 5
367153|NCT01075971|P1|Participant Flow|Buprenorphine Hydrochloride|8 or 16 mg daily for 5 days; marketed sublingual tablet on Days 1 and 2, fast dissolving tablet (FDT) on Days 3, 4, and 5
367154|NCT01075971|O1|Outcome|Buprenorphine Hydrochloride|8 or 16 mg daily for 5 days; marketed sublingual tablet on Days 1 and 2, fast dissolving tablet (FDT) on Days 3, 4, and 5
367155|NCT01075971|E1|Reported Event|Buprenorphine Hydrochloride|8 or 16 mg daily for 5 days; marketed sublingual tablet on Days 1 and 2, fast dissolving tablet (FDT) on Days 3, 4, and 5
367156|NCT01075958|B1|Baseline|Healthy Participants|Participants declared themselves as healthy, a non-smoker and prescription and herbal medication free.
367157|NCT01075958|P1|Participant Flow|Healthy Participants|Participants declared themselves as healthy, a non-smoker and prescription and herbal medication free.
367158|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
367159|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
367160|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
367161|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
367162|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
367163|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
367164|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
367165|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
367166|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
367167|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
367168|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
367169|NCT01075958|E1|Reported Event|Healthy Participants|Participants declared themselves as healthy, a non-smoker and prescription and herbal medication free.
367170|NCT01075815|B3|Baseline|Total|Total of all reporting groups
367171|NCT01075815|B2|Baseline|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
367172|NCT01075815|B1|Baseline|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
367173|NCT01075815|P2|Participant Flow|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
367174|NCT01075815|P1|Participant Flow|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
367175|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
367176|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
367177|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
367178|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
367179|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
367227|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
367180|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
367181|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
367182|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
367183|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
367184|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
367185|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
367186|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
367187|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
367188|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
367189|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
367190|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
367191|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
367192|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
367193|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
367194|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
367195|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
367196|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
367197|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
367198|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
367199|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
367200|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
367201|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
367202|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
367203|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
367204|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
367205|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
367206|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
367207|NCT01075815|E2|Reported Event|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
367208|NCT01075815|E1|Reported Event|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
367209|NCT01075763|B3|Baseline|Total|Total of all reporting groups
367210|NCT01075763|B2|Baseline|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
367211|NCT01075763|B1|Baseline|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
367212|NCT01075763|P2|Participant Flow|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
367213|NCT01075763|P1|Participant Flow|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
367214|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
367215|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
367216|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
367217|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
367218|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
367219|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
367220|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
367221|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
367222|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
367223|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
367224|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
367225|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
367226|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
367228|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
367229|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
367230|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
367231|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
367232|NCT01075763|E2|Reported Event|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
367233|NCT01075763|E1|Reported Event|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
367234|NCT01075685|B3|Baseline|Total|Total of all reporting groups
367235|NCT01075685|B2|Baseline|Minimum Information|
367236|NCT01075685|B1|Baseline|Web-based Alcohol Programme|
367237|NCT01075685|P2|Participant Flow|Minimum Information|
367238|NCT01075685|P1|Participant Flow|Web-based Alcohol Programme|
367239|NCT01075685|O2|Outcome|Minimum Information|
367240|NCT01075685|O1|Outcome|Web-based Alcohol Programme|
367241|NCT01075685|O2|Outcome|Minimum Information|
367242|NCT01075685|O1|Outcome|Web-based Alcohol Programme|
367243|NCT01075685|O2|Outcome|Minimum Information|
367244|NCT01075685|O1|Outcome|Web-based Alcohol Programme|
367245|NCT01075685|O2|Outcome|Minimum Information|
367246|NCT01075685|O1|Outcome|Web-based Alcohol Programme|
367247|NCT01075685|E2|Reported Event|Minimum Information|
367248|NCT01075685|E1|Reported Event|Web-based Alcohol Programme|
367249|NCT01075646|B5|Baseline|Total|Total of all reporting groups
367250|NCT01075646|B4|Baseline|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
367251|NCT01075646|B3|Baseline|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
367252|NCT01075646|B2|Baseline|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
367253|NCT01075646|B1|Baseline|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
367254|NCT01075646|P4|Participant Flow|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
367255|NCT01075646|P3|Participant Flow|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
367256|NCT01075646|P2|Participant Flow|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
367257|NCT01075646|P1|Participant Flow|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
367258|NCT01075646|O4|Outcome|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
367259|NCT01075646|O3|Outcome|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
367260|NCT01075646|O2|Outcome|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
367311|NCT01075347|O1|Outcome|Autologous Serum Use|Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty
367261|NCT01075646|O1|Outcome|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
367262|NCT01075646|O4|Outcome|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
367263|NCT01075646|O3|Outcome|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
367264|NCT01075646|O2|Outcome|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
367265|NCT01075646|O1|Outcome|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
367266|NCT01075646|O4|Outcome|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
367267|NCT01075646|O3|Outcome|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
367268|NCT01075646|O2|Outcome|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
367269|NCT01075646|O1|Outcome|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
367270|NCT01075646|O4|Outcome|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
367271|NCT01075646|O3|Outcome|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
367272|NCT01075646|O2|Outcome|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
367273|NCT01075646|O1|Outcome|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
367274|NCT01075646|O4|Outcome|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
367275|NCT01075646|O3|Outcome|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
367276|NCT01075646|O2|Outcome|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
367277|NCT01075646|O1|Outcome|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
367278|NCT01075646|O4|Outcome|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
367279|NCT01075646|O3|Outcome|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
367280|NCT01075646|O2|Outcome|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
367281|NCT01075646|O1|Outcome|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
367282|NCT01075646|E4|Reported Event|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
367283|NCT01075646|E3|Reported Event|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
367284|NCT01075646|E2|Reported Event|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
367285|NCT01075646|E1|Reported Event|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
367286|NCT01075412|B3|Baseline|Total|Total of all reporting groups
367287|NCT01075412|B2|Baseline|Group 2|"Receives fourth [F18]Fluorothymidine (FLT) PET scan after 20 fractions of radiation therapy.~[F18]Fluorothymidine: FLT PET scan 5 mCi (+/- 10%)"
367288|NCT01075412|B1|Baseline|Group 1|"Receives fourth [F18]Fluorothymidine (FLT) PET scan after 15 fractions of radiation therapy.~[F18]Fluorothymidine: FLT PET scan 5 mCi (+/- 10%)"
367289|NCT01075412|P2|Participant Flow|Group 2|"Receives fourth [F18]Fluorothymidine (FLT) PET scan after 20 fractions of radiation therapy. If no bone marrow uptake is seen at the second or third FLT PET scan, this scan is omitted to reduce radiation risk.~[F18]Fluorothymidine: FLT PET scan 5 mCi (+/- 10%)"
367290|NCT01075412|P1|Participant Flow|Group 1|"Scheduled to receive the fourth [F18]Fluorothymidine (FLT) PET scan after 15 fractions of radiation therapy. If no bone marrow uptake is seen at the second or third FLT PET scan, this scan is omitted to reduce radiation risk.~[F18]Fluorothymidine: FLT PET scan 5 mCi (+/- 10%)"
367291|NCT01075412|O1|Outcome|All Participants|The outcome measure is evaluated by including study participants from both groups.
367292|NCT01075412|O1|Outcome|All Participants|The outcome measure is evaluated by including study participants from both groups.
367293|NCT01075412|O1|Outcome|All Participants|The outcome measure is evaluated by including study participants from both groups.
367294|NCT01075412|O1|Outcome|All Participants|The outcome measure is evaluated by including study participants from both groups.
367295|NCT01075412|O1|Outcome|All Participants|The outcome measure is evaluated by including study participants from both groups.
367296|NCT01075412|O1|Outcome|All Participants|The outcome measure is evaluated by including study participants from both groups.
367297|NCT01075412|E2|Reported Event|Group 2|"Receives fourth [F18]Fluorothymidine (FLT) PET scan after 20 fractions of radiation therapy.~[F18]Fluorothymidine: FLT PET scan 5 mCi (+/- 10%)"
367298|NCT01075412|E1|Reported Event|Group 1|"Receives fourth [F18]Fluorothymidine (FLT) PET scan after 15 fractions of radiation therapy.~[F18]Fluorothymidine: FLT PET scan 5 mCi (+/- 10%)"
367299|NCT01075399|B1|Baseline|[F 18]HX4|[F 18]HX4 : Approximately forty (40) patients who have diagnosis confirmed by histopathological examination of tumor tissue from head/neck, lung, liver, rectal or cervical cancers and will receive chemotherapy, radiation therapy or chemoradiotherapy, will be imaged under PET/CT with [F 18]HX4
367300|NCT01075399|P1|Participant Flow|[F 18]HX4|[F 18]HX4 : Approximately forty (40) patients who have diagnosis confirmed by histopathological examination of tumor tissue from head/neck, lung, liver, rectal or cervical cancers and will receive chemotherapy, radiation therapy or chemoradiotherapy, will be imaged under PET/CT with [F 18]HX4
367301|NCT01075399|O1|Outcome|Subjects That Received 1st and 2nd [F18] HX4 Scans|Single arm study. This group includes all subjects that successfully received [F18]HX4 PET scan on 2 separate occasions within 6 days apart to assess reproducibility in measuring tumor hypoxia.
367302|NCT01075399|E1|Reported Event|[F 18]HX4|[F 18]HX4 : Approximately forty (40) patients who have diagnosis confirmed by histopathological examination of tumor tissue from head/neck, lung, liver, rectal or cervical cancers and will receive chemotherapy, radiation therapy or chemoradiotherapy, will be imaged under PET/CT with [F 18]HX4
367303|NCT01075347|B3|Baseline|Total|Total of all reporting groups
367304|NCT01075347|B2|Baseline|Non-autologous Serum Use|Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
367305|NCT01075347|B1|Baseline|Autologous Serum Use|Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty
367306|NCT01075347|P2|Participant Flow|Non-autologous Serum Use|Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
367307|NCT01075347|P1|Participant Flow|Autologous Serum Use|Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty
367308|NCT01075347|O2|Outcome|Non-autologous Serum Use|Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
367309|NCT01075347|O1|Outcome|Autologous Serum Use|Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty
367310|NCT01075347|O2|Outcome|Non-autologous Serum Use|Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
367312|NCT01075347|E2|Reported Event|Non-autologous Serum Use|Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
367313|NCT01075347|E1|Reported Event|Autologous Serum Use|Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty
367314|NCT01075282|B4|Baseline|Total|Total of all reporting groups
367315|NCT01075282|B3|Baseline|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367316|NCT01075282|B2|Baseline|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367317|NCT01075282|B1|Baseline|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367318|NCT01075282|P3|Participant Flow|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367319|NCT01075282|P2|Participant Flow|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367320|NCT01075282|P1|Participant Flow|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367321|NCT01075282|O1|Outcome|LY2189265 1.5 mg and 0.75 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg) or 0.75 mg, subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367322|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367323|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367324|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367325|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367326|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367327|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367328|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367329|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367330|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367331|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367332|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367333|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367334|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367335|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367336|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367337|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367338|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367339|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
369077|NCT01071252|B5|Baseline|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
367340|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367341|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367342|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367343|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367344|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367345|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367346|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367347|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367348|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367349|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367350|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367351|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367352|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367353|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367354|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367355|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367356|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367357|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367358|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367359|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367360|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367361|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367362|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367363|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367364|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367365|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367366|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367367|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367368|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367369|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367370|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367371|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367372|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367373|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367374|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367375|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367376|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367377|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367378|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367379|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367380|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367381|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367382|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367383|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367384|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367385|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367386|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367387|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367388|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367389|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367390|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367391|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367392|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367393|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367394|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367395|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367396|NCT01075282|E3|Reported Event|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367397|NCT01075282|E2|Reported Event|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367398|NCT01075282|E1|Reported Event|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
367399|NCT01075256|B4|Baseline|Total|Total of all reporting groups
367400|NCT01075256|B3|Baseline|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
367401|NCT01075256|B2|Baseline|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
367402|NCT01075256|B1|Baseline|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
367403|NCT01075256|P3|Participant Flow|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
367404|NCT01075256|P2|Participant Flow|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
367405|NCT01075256|P1|Participant Flow|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
367406|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
367407|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
367408|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
367409|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
367410|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
367411|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
367412|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
367413|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
367414|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
367415|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with a sodium calcium phosphosilicate (NovaMin) free placebo toothpaste. All study treatments were fluoride free.
367416|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
367417|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
367418|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
367419|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
367420|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
367421|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
367422|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
367423|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
367541|NCT01075178|O1|Outcome|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
367424|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
367425|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
367426|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
367427|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
367428|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
367429|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
367430|NCT01075256|E3|Reported Event|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
367431|NCT01075256|E2|Reported Event|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
367432|NCT01075256|E1|Reported Event|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
367433|NCT01075243|B4|Baseline|Total|Total of all reporting groups
367434|NCT01075243|B3|Baseline|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
367435|NCT01075243|B2|Baseline|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
367436|NCT01075243|B1|Baseline|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
367437|NCT01075243|P3|Participant Flow|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
367438|NCT01075243|P2|Participant Flow|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
367439|NCT01075243|P1|Participant Flow|Paracetamol Caplet 1000 Milligrams (mg)|Participants were administered with two paracetamol fast dissolving (FD) 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 milliliter (mL) of water through oral route.
367440|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
367441|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
367442|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
367443|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
367444|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
367445|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
367446|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
367447|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
367448|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
367449|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
367450|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
367451|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
367452|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
367453|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
367454|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
367455|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
367456|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
370644|NCT01067976|O1|Outcome|CMRM vs UMRM|
367457|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
367458|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
367459|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
367460|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
367461|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
367462|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
367463|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
367464|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
367465|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
367466|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
367467|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
367468|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
367469|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
367470|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
367471|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
367472|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
367473|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
367474|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
367475|NCT01075243|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
367476|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
367477|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
367478|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
367479|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
367480|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
367481|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
367482|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
367483|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
367484|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
367485|NCT01075243|E3|Reported Event|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
367486|NCT01075243|E2|Reported Event|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
367487|NCT01075243|E1|Reported Event|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
367488|NCT01075217|B3|Baseline|Total|Total of all reporting groups
367489|NCT01075217|B2|Baseline|Visipaque 270|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
367542|NCT01075178|O2|Outcome|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
370645|NCT01067976|O5|Outcome|CMRM+XRM|
367490|NCT01075217|B1|Baseline|Isovue 250|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
367491|NCT01075217|P2|Participant Flow|Visipaque 270|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
367492|NCT01075217|P1|Participant Flow|Isovue 250|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
367493|NCT01075217|O2|Outcome|Visipaque 270 Quality of Opacification After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
367494|NCT01075217|O1|Outcome|Isovue 250 Quality of Opacification After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
367495|NCT01075217|O2|Outcome|Visipaque 270 Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
367496|NCT01075217|O1|Outcome|Isovue 250 Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
367497|NCT01075217|O2|Outcome|Visipaque 270 Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
367498|NCT01075217|O1|Outcome|Isovue 250 Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
367499|NCT01075217|O2|Outcome|Visipaque 270 VAS Score Immedicately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
367500|NCT01075217|O1|Outcome|Isovue 250 VAS Score Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
367501|NCT01075217|O4|Outcome|Visipaque 270 VAS Score Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
367502|NCT01075217|O3|Outcome|Visipaque 270 VAS Score Prior to Injection (Baseline)|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
367503|NCT01075217|O2|Outcome|Isovue 250 VAS Score Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
367504|NCT01075217|O1|Outcome|Isovue 250 VAS Score Prior to Injection (Baseline)|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
367505|NCT01075217|E2|Reported Event|Visipaque 270|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
367506|NCT01075217|E1|Reported Event|Isovue 250|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
367507|NCT01075204|B1|Baseline|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
367508|NCT01075204|P1|Participant Flow|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
367509|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
367510|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
367511|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
370646|NCT01067976|O4|Outcome|UMRM+XRM|
367512|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
367513|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
367514|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
367515|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
367516|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
367517|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
367518|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
367519|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
367520|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
367521|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
367522|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
367523|NCT01075204|E1|Reported Event|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
367524|NCT01075191|B1|Baseline|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
367525|NCT01075191|P1|Participant Flow|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
367526|NCT01075191|O1|Outcome|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
367527|NCT01075191|O1|Outcome|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
367528|NCT01075191|O1|Outcome|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
367529|NCT01075191|O1|Outcome|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
367530|NCT01075191|O1|Outcome|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
367531|NCT01075191|O1|Outcome|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
367532|NCT01075191|E1|Reported Event|HIV-infected Participants|"HIV-infected patients taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily).~Safety data presents all enrolled participants, including 5 protocol violations."
367533|NCT01075178|B3|Baseline|Total|Total of all reporting groups
367534|NCT01075178|B2|Baseline|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
367535|NCT01075178|B1|Baseline|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
367536|NCT01075178|P2|Participant Flow|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
367537|NCT01075178|P1|Participant Flow|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
367538|NCT01075178|O2|Outcome|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
367539|NCT01075178|O1|Outcome|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
367540|NCT01075178|O2|Outcome|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
367543|NCT01075178|O1|Outcome|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
367544|NCT01075178|O2|Outcome|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
367545|NCT01075178|O1|Outcome|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
367546|NCT01075178|E2|Reported Event|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
367547|NCT01075178|E1|Reported Event|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
367548|NCT01075152|B3|Baseline|Total|Total of all reporting groups
367549|NCT01075152|B2|Baseline|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis diagnosis (+/- 1 week)
367550|NCT01075152|B1|Baseline|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis.
367551|NCT01075152|P2|Participant Flow|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis diagnosis (+/1 week)
367552|NCT01075152|P1|Participant Flow|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal diagnosis
367553|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
367554|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
367555|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
367556|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
367557|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
367558|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
367559|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
367560|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis]
367561|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
367562|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
367563|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
367564|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
367565|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
367566|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
367567|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
367568|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
367569|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
367570|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
367571|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week).
367572|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
367573|NCT01075152|E2|Reported Event|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
367574|NCT01075152|E1|Reported Event|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
367575|NCT01075100|B3|Baseline|Total|Total of all reporting groups
367576|NCT01075100|B2|Baseline|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
367577|NCT01075100|B1|Baseline|Triple Negative|ER-/PR-/HER2- patients who received receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
367578|NCT01075100|P2|Participant Flow|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
367579|NCT01075100|P1|Participant Flow|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
367580|NCT01075100|O2|Outcome|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
367581|NCT01075100|O1|Outcome|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
367582|NCT01075100|O2|Outcome|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
367583|NCT01075100|O1|Outcome|Triple Negative|ER-/PR-/HER2- patients who receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
367584|NCT01075100|O2|Outcome|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
367585|NCT01075100|O1|Outcome|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
367586|NCT01075100|O2|Outcome|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
367587|NCT01075100|O1|Outcome|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
367588|NCT01075100|O2|Outcome|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
367589|NCT01075100|O1|Outcome|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
367590|NCT01075100|O2|Outcome|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
367591|NCT01075100|O1|Outcome|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
367592|NCT01075100|E2|Reported Event|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
367593|NCT01075100|E1|Reported Event|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
367594|NCT01075087|B3|Baseline|Total|Total of all reporting groups
367595|NCT01075087|B2|Baseline|Active Comparator|"(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.~(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side."
367596|NCT01075087|B1|Baseline|Placebo|"(control group) will receive sterile normal saline in the block~Placebo: Bilateral TAP block using sterile normal saline."
367597|NCT01075087|P2|Participant Flow|Active Comparator|"(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.~(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side."
367598|NCT01075087|P1|Participant Flow|Placebo|"(control group) will receive sterile normal saline in the block~Placebo: Bilateral TAP block using sterile normal saline."
367599|NCT01075087|O2|Outcome|Active Comparator|"(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.~(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side."
367600|NCT01075087|O1|Outcome|Placebo|"(control group) will receive sterile normal saline in the block~Placebo: Bilateral TAP block using sterile normal saline."
367601|NCT01075087|O2|Outcome|Active Comparator|"(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.~(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side."
367602|NCT01075087|O1|Outcome|Placebo|"(control group) will receive sterile normal saline in the block~Placebo: Bilateral TAP block using sterile normal saline."
367603|NCT01075087|E2|Reported Event|Active Comparator|(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
367604|NCT01075087|E1|Reported Event|Placebo|"(control group) will receive sterile normal saline in the block~Placebo: Bilateral TAP block using sterile normal saline."
367605|NCT01075074|B4|Baseline|Total|Total of all reporting groups
367606|NCT01075074|B3|Baseline|Ropivacaine 0.25%|Subjects received a bilateral transversus abdominis plane block using 15cc of ropivacaine 0.025%
367607|NCT01075074|B2|Baseline|Normal Saline|Subjects received a transversus abdominis plane block using 15 cc of sterile normal saline
367608|NCT01075074|B1|Baseline|Ropivacaine 0.05%|Subjects received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine
367609|NCT01075074|P3|Participant Flow|Ropivacaine 0.25%|Subjects received a bilateral transversus abdominis plane block using 15cc of ropivacaine 0.025%
367610|NCT01075074|P2|Participant Flow|Normal Saline|Subjects received a transversus abdominis plane block using 15 cc of sterile normal saline
367611|NCT01075074|P1|Participant Flow|Ropivacaine 0.05%|Subjects received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine
367612|NCT01075074|O3|Outcome|Ropivacaine 0.25%|The ropivacaine 0.25% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.25% ropivacaine on each side
367613|NCT01075074|O2|Outcome|Normal Saline|The control group will receive a bilateral transversus abdominal plane block using 15 cc of sterile normal saline.
367614|NCT01075074|O1|Outcome|Ropivacaine 0.5%|The ropivacaine 0.5% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.5% ropivacaine on each side
367615|NCT01075074|O3|Outcome|Ropivacaine 0.25%|Ropivicaine 0.25% group will receive a bilateral transversus abdominis plane block using 15 cc of 0.25% ropivacaine on each side
367616|NCT01075074|O2|Outcome|Normal Saline|Normal saline group will receive a bilateral transversus abdominis plane block 15 cc of sterile normal saline.
367617|NCT01075074|O1|Outcome|Ropivacaine 0.5%|Ropivacaine 0.5% group will receive a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine on each side
367618|NCT01075074|O3|Outcome|Ropivacaine 0.25%|The ropivacaine 0.25% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.25% ropivacaine on each side
367619|NCT01075074|O2|Outcome|Normal Saline|The normal saline group will receive a bilateral transversus abdominal plane block using 15 cc of sterile normal saline.
367620|NCT01075074|O1|Outcome|Ropivacaine 0.5%|The ropivacaine 0.5% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.5% ropivacaine on each side
367621|NCT01075074|O3|Outcome|Ropivacaine 0.25%|The ropivacaine 0.25% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.25% ropivacaine on each side
367622|NCT01075074|O2|Outcome|Normal Saline|The control group will receive a bilateral transversus abdominal plane block using 15 cc of sterile normal saline.
367623|NCT01075074|O1|Outcome|Ropivacaine 0.5%|The ropivacaine 0.5% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.5% ropivacaine on each side
367624|NCT01075074|E3|Reported Event|Ropivacaine 0.25%|Subjects received a bilateral transversus abdominis plane block using 15cc of ropivicaine 0.25%
367625|NCT01075074|E2|Reported Event|Normal Saline|Subjects received a bilateral transversus abdominis plane block using 15 cc of sterile normal saline.
367626|NCT01075074|E1|Reported Event|Ropivacaine 0.5%|Subjects received a bilateral transversus abdominis plane block using 15 cc of 0.5% ropivacaine
367696|NCT01074931|E1|Reported Event|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
367627|NCT01074944|B1|Baseline|All Participants|All participants who received treatment in LIP (eliglustat 50 mg BID on Day 1 titrated up to 100 mg BID [50 or 100 mg capsules] based on their individual PK data for up to 78 weeks [except for the participants in Japan]. Participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID [50 or 100 mg capsules] based on their individual PK data for up to 78 weeks) and assessed for randomization.
367628|NCT01074944|P5|Participant Flow|ETP, Eliglustat|All participants who did not meet all the randomization criteria at Week 78 of the LIP continued in the ETP and received eliglustat capsules at the same dose as they were receiving at the end of LIP till the end of the study.
367629|NCT01074944|P4|Participant Flow|LTTP, Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
367630|NCT01074944|P3|Participant Flow|PAP, Eliglustat: Twice Daily|All participants who were randomized after meeting all randomization criteria (defined as: no more than 1 bone crisis and was free of other clinically symptomatic bone disease [such as bone pain attributable to osteonecrosis and/or pathological fractures) during the first 6 months of the LIP; mean hemoglobin level of ≥11 g/dL [if female] and ≥12 g/dL [if male]; mean platelet count ≥100,000/mm^3; spleen volume ≤10 times of normal; liver volume ≤1.5 times of normal; had a dose of 50 mg BID or 100 mg BID of eliglustat for at least 4 months and a peak (2-hour) Genz-99067 plasma concentration of <50 ng/mL) after either 26, 52 or 78 weeks of LIP, received eliglustat at the TDD 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367631|NCT01074944|P2|Participant Flow|PAP, Eliglustat: Once Daily|All participants who were randomized after meeting all randomization criteria (defined as: no more than 1 bone crisis and was free of other clinically symptomatic bone disease [such as bone pain attributable to osteonecrosis and/or pathological fractures) during the first 6 months of the LIP; mean hemoglobin level of ≥11 g/dL [if female] and ≥12 g/dL [if male]; mean platelet count ≥100,000/mm^3; spleen volume ≤10 times of normal; liver volume ≤1.5 times of normal; had a dose of 50 mg BID or 100 mg BID of eliglustat for at least 4 months and a peak (2-hour) Genz-99067 plasma concentration of <50 ng/mL) after either 26, 52 or 78 weeks of LIP received eliglustat capsules at the total daily dose (TDD) of 100 mg or 200 mg (the TDD they were on before randomization) once daily (QD) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367632|NCT01074944|P1|Participant Flow|LIP, Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual pharmacokinetics (PK) data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
367633|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
367634|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
367635|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
367661|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367662|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367636|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
367637|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
367638|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
367639|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
367640|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
367641|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
367642|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
367663|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367664|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367697|NCT01074658|B1|Baseline|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System.
367643|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
367644|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
367645|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
367646|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
367647|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
367648|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
367649|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
367650|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg BID on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
367651|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg BID on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
367652|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg BID on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
367653|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg BID on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
367654|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367655|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367656|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367657|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367658|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367659|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367660|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
370647|NCT01067976|O3|Outcome|X-ray Mammography (XRM)|
367665|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367666|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367667|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367668|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367669|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367670|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367671|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367672|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367673|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367674|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367675|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367676|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367677|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367678|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367679|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367680|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367681|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367682|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367683|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
367684|NCT01074944|E1|Reported Event|Eliglustat|All participants who received eliglustat at the TDD of 100 mg or 200 mg in the LIP, PAP, LTTP or ETP.
367685|NCT01074931|B1|Baseline|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
367686|NCT01074931|P1|Participant Flow|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
367687|NCT01074931|O2|Outcome|Lopinavir/Ritonavir Group: Treatment-experienced|The subgroup of participants who had previously received antiretroviral drug therapy.
367688|NCT01074931|O1|Outcome|Lopinavir/Ritonavir Group: Treatment-naive|The subgroup of participants who had not received prior antiretroviral drug therapy.
367689|NCT01074931|O1|Outcome|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
367690|NCT01074931|O1|Outcome|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
367691|NCT01074931|O1|Outcome|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
367692|NCT01074931|O2|Outcome|Lopinavir/Ritonavir: Treatment-experienced|The subgroup of participants who had previously received antiretroviral drug therapy.
367693|NCT01074931|O1|Outcome|Lopinavir/Ritonavir: Treatment-naive|The subgroup of participants who had not received prior antiretroviral drug therapy.
367694|NCT01074931|O2|Outcome|Lopinavir/Ritonavir: Treatment-experienced|The subgroup of participants who had previously received antiretroviral drug therapy.
367695|NCT01074931|O1|Outcome|Lopinavir/Ritonavir: Treatment-naive|The subgroup of participants who had not received prior antiretroviral drug therapy.
367698|NCT01074658|P1|Participant Flow|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System.
367699|NCT01074658|O1|Outcome|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
367700|NCT01074658|O1|Outcome|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
367701|NCT01074658|O1|Outcome|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
367702|NCT01074658|E1|Reported Event|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
367703|NCT01074554|B3|Baseline|Total|Total of all reporting groups
367704|NCT01074554|B2|Baseline|Lactose Tablets|Patients who are randomized to control arm will receive an equivalent number of lactose tablets.
367705|NCT01074554|B1|Baseline|Antibiotics|This study will compare the effects of antibiotics or placebo on resolution of cutaneous sarcoidosis lesions.
367706|NCT01074554|P2|Participant Flow|Lactose Tablets|Patients who are randomized to control arm will receive an equivalent number of lactose tablets.
367707|NCT01074554|P1|Participant Flow|Antibiotics|This study will compare the effects of antibiotics or placebo on resolution of cutaneous sarcoidosis lesions.
367708|NCT01074554|O2|Outcome|Placebo Regimen|The placebo regimen consists of Lactose tablets, one for each antibiotic with equivalent pills
367709|NCT01074554|O1|Outcome|Antibiotic Regimen|"The Antibiotic Regimen consists of Levaquin 750 mg loading on day 1, then 500 mg po QD and Ethambutol 15-25 mg/kg for a maximum of 1200mg QD and Azithromycin 500mg on day 1, then 250 mg po QD and Rifampin 5-10 mg/kg for a maximum of 300mg po QD.~All four drugs are given concomitantly."
367710|NCT01074554|O2|Outcome|Placebo Regimen|The placebo regimen consists of Lactose tablets, one for each antibiotic with equivalent pills
367711|NCT01074554|O1|Outcome|Antibiotic Regimen|"The Antibiotic Regimen consists of Levaquin 750 mg loading on day 1, then 500 mg po QD and Ethambutol 15-25 mg/kg for a maximum of 1200mg QD and Azithromycin 500mg on day 1, then 250 mg po QD and Rifampin 5-10 mg/kg for a maximum of 300mg po QD.~All four drugs are given concomitantly."
367712|NCT01074554|O2|Outcome|Placebo Regimen|The placebo regimen consists of Lactose tablets, one for each antibiotic with equivalent pills
367713|NCT01074554|O1|Outcome|Antibiotic Regimen|"The Antibiotic Regimen consists of Levaquin 750 mg loading on day 1, then 500 mg po QD and Ethambutol 15-25 mg/kg for a maximum of 1200mg QD and Azithromycin 500mg on day 1, then 250 mg po QD and Rifampin 5-10 mg/kg for a maximum of 300mg po QD.~All four drugs are given concomitantly."
367714|NCT01074554|E2|Reported Event|Lactose Tablets|Patients who are randomized to control arm will receive an equivalent number of lactose tablets.
367715|NCT01074554|E1|Reported Event|Antibiotics|This study will compare the effects of antibiotics or placebo on resolution of cutaneous sarcoidosis lesions.
367716|NCT01074502|B1|Baseline|Apremilast|apremilast 20 mgs twice a day for 12 weeks
367717|NCT01074502|P1|Participant Flow|Apremilast|apremilast 20 mgs twice a day for 12 weeks
367718|NCT01074502|O1|Outcome|Apremilast|apremilast 20 mgs twice a day for 12 weeks
367719|NCT01074502|O1|Outcome|Apremilast|apremilast 20 mgs twice a day for 12 weeks
367720|NCT01074502|O1|Outcome|Apremilast|apremilast 20 mgs twice a day for 12 weeks
367721|NCT01074502|O1|Outcome|Apremilast|apremilast 20 mgs twice a day for 12 weeks
367722|NCT01074502|O1|Outcome|Apremilast|apremilast 20 mgs twice a day for 12 weeks
367723|NCT01074502|O1|Outcome|Apremilast|apremilast 20 mgs twice a day for 12 weeks
367724|NCT01074502|E1|Reported Event|Apremilast|apremilast 20 mgs twice a day for 12 weeks
367725|NCT01074463|B3|Baseline|Total|Total of all reporting groups
367726|NCT01074463|B2|Baseline|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
367727|NCT01074463|B1|Baseline|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
367728|NCT01074463|P2|Participant Flow|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
367729|NCT01074463|P1|Participant Flow|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
367730|NCT01074463|O2|Outcome|Reference (Mirapex®)|0.25 mg Mirapex® Tablets reference product dosed in either period.
367731|NCT01074463|O1|Outcome|Test (Pramipexole Dihydrochloride)|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
367732|NCT01074463|O2|Outcome|Reference (Mirapex®)|0.25 mg Mirapex® Tablets reference product dosed in either period.
367733|NCT01074463|O1|Outcome|Test (Pramipexole Dihydrochloride)|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
367734|NCT01074463|O2|Outcome|Reference (Mirapex®)|0.25 mg Mirapex® Tablets reference product dosed in either period.
367735|NCT01074463|O1|Outcome|Test (Pramipexole Dihydrochloride)|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
367736|NCT01074463|E2|Reported Event|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
367737|NCT01074463|E1|Reported Event|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
367738|NCT01074450|B3|Baseline|Total|Total of all reporting groups
367739|NCT01074450|B2|Baseline|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
367740|NCT01074450|B1|Baseline|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
369078|NCT01071252|B4|Baseline|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
367741|NCT01074450|P2|Participant Flow|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
367742|NCT01074450|P1|Participant Flow|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
367743|NCT01074450|O2|Outcome|Reference (Mirapex®)|0.25 mg Mirapex® Tablets reference product dosed in either period.
367744|NCT01074450|O1|Outcome|Test (Pramipexole Dihydrochloride)|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
367745|NCT01074450|O2|Outcome|Reference (Mirapex®)|0.25 mg Mirapex® Tablets reference product dosed in either period.
367746|NCT01074450|O1|Outcome|Test (Pramipexole Dihydrochloride)|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
367747|NCT01074450|O2|Outcome|Reference (Mirapex®)|0.25 mg Mirapex® Tablets reference product dosed in either period.
367748|NCT01074450|O1|Outcome|Test (Pramipexole Dihydrochloride)|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
367749|NCT01074450|E2|Reported Event|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
367750|NCT01074450|E1|Reported Event|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
367751|NCT01074437|B3|Baseline|Total|Total of all reporting groups
367752|NCT01074437|B2|Baseline|Group B: Corticosteroid With Propranolol|Group B will receive oral liquid prednisolone, and oral propranolol. As in Group A, the dose of prednisolone will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. Oral liquid propranolol will be dosed at 2 mg/kg/day, following initiation in the Cardiology Clinic. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone.
367753|NCT01074437|B1|Baseline|Group A: Corticosteroid With Placebo|Group A will receive oral, liquid Prednisolone, which is the standard corticosteroid that we use here at Seattle Children's, and oral liquid placebo. The dose of prednisolone that Group A will receive will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. This is a standard dose for IH treatment. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone. This treatment will be given for two months, as is our standard practice.
367754|NCT01074437|P2|Participant Flow|Group B: Corticosteroid With Propranolol|Group B will receive oral liquid prednisolone, and oral propranolol. As in Group A, the dose of prednisolone will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. Oral liquid propranolol will be dosed at 2 mg/kg/day, following initiation in the Cardiology Clinic. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone.
367755|NCT01074437|P1|Participant Flow|Group A: Corticosteroid With Placebo|Group A will receive oral, liquid Prednisolone, which is the standard corticosteroid that we use here at Seattle Children's, and oral liquid placebo. The dose of prednisolone that Group A will receive will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. This is a standard dose for IH treatment. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone. This treatment will be given for two months, as is our standard practice.
367756|NCT01074437|O2|Outcome|Group B: Corticosteroid With Propranolol|Group B will receive oral liquid prednisolone, and oral propranolol. As in Group A, the dose of prednisolone will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. Oral liquid propranolol will be dosed at 2 mg/kg/day, following initiation in the Cardiology Clinic. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone.
367757|NCT01074437|O1|Outcome|Group A: Corticosteroid With Placebo|Group A will receive oral, liquid Prednisolone, which is the standard corticosteroid that we use here at Seattle Children's, and oral liquid placebo. The dose of prednisolone that Group A will receive will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. This is a standard dose for IH treatment. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone. This treatment will be given for two months, as is our standard practice.
367758|NCT01074437|E2|Reported Event|Group B: Corticosteroid With Propranolol|Group B will receive oral liquid prednisolone, and oral propranolol. As in Group A, the dose of prednisolone will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. Oral liquid propranolol will be dosed at 2 mg/kg/day, following initiation in the Cardiology Clinic. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone.
367759|NCT01074437|E1|Reported Event|Group A: Corticosteroid With Placebo|Group A will receive oral, liquid Prednisolone, which is the standard corticosteroid that we use here at Seattle Children's, and oral liquid placebo. The dose of prednisolone that Group A will receive will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. This is a standard dose for IH treatment. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone. This treatment will be given for two months, as is our standard practice.
367760|NCT01074307|B3|Baseline|Total|Total of all reporting groups
367761|NCT01074307|B2|Baseline|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
367762|NCT01074307|B1|Baseline|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
368491|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
367763|NCT01074307|P2|Participant Flow|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
367764|NCT01074307|P1|Participant Flow|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
367765|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
367766|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
367767|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
367768|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
367769|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
367770|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
367771|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
367772|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
367773|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
367774|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
367775|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
367776|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
367777|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
367778|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
367801|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367779|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
367780|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
367781|NCT01074307|E2|Reported Event|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
367782|NCT01074307|E1|Reported Event|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
367783|NCT01074268|B3|Baseline|Total|Total of all reporting groups
367784|NCT01074268|B2|Baseline|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367785|NCT01074268|B1|Baseline|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367786|NCT01074268|P2|Participant Flow|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367787|NCT01074268|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367788|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367789|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367790|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367791|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367792|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367793|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367794|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367795|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367796|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367797|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367798|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367799|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367800|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
368492|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
373597|NCT01059760|O1|Outcome|Baseline Value|
367802|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367803|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367804|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367805|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367806|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367807|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367808|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367809|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367810|NCT01074268|E2|Reported Event|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367811|NCT01074268|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
367812|NCT01074255|B1|Baseline|Korean Participants Treated With EMEND (Aprepitant)|EMEND (125 mg oral capsules) is administered 1 hour prior to chemotherapy on Treatment Day 1. EMEND (80 mg) is administered on the morning of Days 2 and 3. EMEND is concomitantly administered with a regimen of a corticosteroid and a 5-HT3 antagonist.
367813|NCT01074255|P1|Participant Flow|Korean Participants Treated With EMEND (Aprepitant)|EMEND (125 mg oral capsules) is administered 1 hour prior to chemotherapy on Treatment Day 1. EMEND (80 mg) is administered on the morning of Days 2 and 3. EMEND is concomitantly administered with a regimen of a corticosteroid and a 5-HT3 antagonist.
367814|NCT01074255|O1|Outcome|Participants Treated With EMEND|
367815|NCT01074255|E1|Reported Event|Participants in the Safety Analysis|Participants included in the Safety Analysis
367816|NCT01074242|B1|Baseline|Rotateq|Korean infants vaccinated with Rotateq in usual practice
367817|NCT01074242|P1|Participant Flow|Rotateq|Korean infants vaccinated with Rotateq in usual practice
367818|NCT01074242|O1|Outcome|Rotateq|Korean infants vaccinated with Rotateq in usual practice
367819|NCT01074242|O1|Outcome|Rotateq|Korean infants vaccinated with Rotateq in usual practice
367820|NCT01074242|E1|Reported Event|Rotateq|Korean infants vaccinated with Rotateq in usual practice
367821|NCT01074229|B4|Baseline|Total|Total of all reporting groups
367822|NCT01074229|B3|Baseline|20 cc of 0.25% Ropivacaine|Active Comparator 2. 20 cc of 0.25% ropivacaine
367823|NCT01074229|B2|Baseline|Study Drug|Group A (study group) 20 cc of 0.5% ropivacaine
367824|NCT01074229|B1|Baseline|Placebo|Group B (control group) will receive sterile normal saline.
367825|NCT01074229|P3|Participant Flow|20 cc of 0.25% Ropivacaine|Active Comparator 2. 20 cc of 0.25% ropivacaine
367826|NCT01074229|P2|Participant Flow|20 cc of 0.5% Ropivacaine|Group A (study group) 20 cc of 0.5% ropivacaine
367827|NCT01074229|P1|Participant Flow|Placebo|Group B (control group) will receive sterile normal saline.
367828|NCT01074229|O3|Outcome|20 cc of 0.25% Ropivacaine|Active Comparator 2. 20 cc of 0.25% ropivacaine
367829|NCT01074229|O2|Outcome|20 cc of 0.5% Ropivacaine|Group A (study group) 20 cc of 0.5% ropivacaine
367830|NCT01074229|O1|Outcome|Placebo|Group B (control group) will receive sterile normal saline.
367831|NCT01074229|O3|Outcome|20 cc of 0.25% Ropivacaine|Active Comparator 2. 20 cc of 0.25% ropivacaine
367832|NCT01074229|O2|Outcome|20 cc of 0.5% Ropivacaine|STUDY DRUG Group A (study group) 20 cc of 0.5% ropivacaine
367833|NCT01074229|O1|Outcome|PLACEBO|Group B (control group) will receive sterile normal saline.
367834|NCT01074229|E3|Reported Event|20 cc of 0.25% Ropivacaine|Active Comparator 2. 20 cc of 0.25% ropivacaine
367835|NCT01074229|E2|Reported Event|Study Drug|Group A (study group) 20 cc of 0.5% ropivacaine
367836|NCT01074229|E1|Reported Event|Placebo|Group B (control group) will receive sterile normal saline.
367837|NCT01074216|B1|Baseline|All Patients|Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
367838|NCT01074216|P1|Participant Flow|All Patients|Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
368191|NCT01073605|B3|Baseline|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
367839|NCT01074216|O1|Outcome|All Patients|Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
367840|NCT01074216|E1|Reported Event|All Patients|Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
367841|NCT01074177|B1|Baseline|BIBW 2992|BIBW 2992: Taken orally once a day
367842|NCT01074177|P1|Participant Flow|BIBW 2992|BIBW 2992: Taken orally once a day
367843|NCT01074177|O1|Outcome|BIBW 2992|BIBW 2992: Taken orally once a day
367844|NCT01074177|O1|Outcome|BIBW 2992|BIBW 2992: Taken orally once a day
367845|NCT01074177|O1|Outcome|BIBW 2992|BIBW 2992: Taken orally once a day
367846|NCT01074177|O1|Outcome|BIBW 2992|BIBW 2992: Taken orally once a day
367847|NCT01074177|E1|Reported Event|BIBW 2992|BIBW 2992: Taken orally once a day
367848|NCT01074164|B3|Baseline|Total|Total of all reporting groups
367849|NCT01074164|B2|Baseline|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
367850|NCT01074164|B1|Baseline|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
367851|NCT01074164|P2|Participant Flow|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
367852|NCT01074164|P1|Participant Flow|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
367853|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
367854|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
367855|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
367856|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
367857|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
367858|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
367859|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
367860|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
367861|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
367862|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
367863|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
367864|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
367865|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
367866|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
368632|NCT01072344|O1|Outcome|Chamomile Extract|"Pharmaceutical grade oral chamomile extract.~Chamomile (Matricaria recutita): 500 mg 3 times daily"
367867|NCT01074164|E2|Reported Event|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
367868|NCT01074164|E1|Reported Event|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
367869|NCT01074125|B4|Baseline|Total|Total of all reporting groups
367870|NCT01074125|B3|Baseline|8 g/Day|8 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
367871|NCT01074125|B2|Baseline|6 g/Day|6 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
367872|NCT01074125|B1|Baseline|1 g/Day|1 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
367873|NCT01074125|P3|Participant Flow|8 g/Day|8 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
367874|NCT01074125|P2|Participant Flow|6 g/Day|6 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
367875|NCT01074125|P1|Participant Flow|1 g/Day|1 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
367876|NCT01074125|O3|Outcome|8 g/Day|"8 g/day KRX-0502 (ferric citrate)~ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
367877|NCT01074125|O2|Outcome|6 g/Day|"6 g/day KRX-0502 (ferric citrate)~ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
367878|NCT01074125|O1|Outcome|1 g/Day|"1 g/day KRX-0502 (ferric citrate)~ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
367879|NCT01074125|O3|Outcome|8 g/Day|8 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
367880|NCT01074125|O2|Outcome|6 g/Day|6 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
367881|NCT01074125|O1|Outcome|1 g/Day|1 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
367882|NCT01074125|O3|Outcome|8 g/Day|"8 g/day KRX-0502 (ferric citrate)~ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
367883|NCT01074125|O2|Outcome|6 g/Day|"6 g/day KRX-0502 (ferric citrate)~ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
367884|NCT01074125|O1|Outcome|1 g/Day|"1 g/day KRX-0502 (ferric citrate)~ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
367885|NCT01074125|E3|Reported Event|8g/Day|Participants received 8g tablet of KRX-0502 (ferric citrate) for 4 weeks
367886|NCT01074125|E2|Reported Event|6g/Day|Participants received 6g tablet of KRX-0502 (ferric citrate) for 4 weeks
367887|NCT01074125|E1|Reported Event|1g/Day|Participants received 1g tablet of KRX-0502 (ferric citrate) for 4 weeks
367888|NCT01074099|B3|Baseline|Total|Total of all reporting groups
367889|NCT01074099|B2|Baseline|BMAC Enhanced CABG|"Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery~BMAC: Injection of BMAC into ischemic myocardium during CABG"
367890|NCT01074099|B1|Baseline|Control|"CABG only~CABG only: Control subjects will undergo CABG surgery without BMAC injection"
367891|NCT01074099|P2|Participant Flow|BMAC Enhanced CABG|"Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery~BMAC: Injection of BMAC into ischemic myocardium during CABG"
367892|NCT01074099|P1|Participant Flow|Control|"CABG only~CABG only: Control subjects will undergo CABG surgery without BMAC injection"
367893|NCT01074099|O2|Outcome|BMAC Enhanced CABG|"Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery~BMAC: Injection of BMAC into ischemic myocardium during CABG"
367894|NCT01074099|O1|Outcome|Control|"CABG only~CABG only: Control subjects will undergo CABG surgery without BMAC injection"
367895|NCT01074099|O2|Outcome|BMAC Enhanced CABG|"Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery~BMAC: Injection of BMAC into ischemic myocardium during CABG"
367896|NCT01074099|O1|Outcome|Control|"CABG only~CABG only: Control subjects will undergo CABG surgery without BMAC injection"
367897|NCT01074099|E2|Reported Event|BMAC Enhanced CABG|"Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery~BMAC: Injection of BMAC into ischemic myocardium during CABG"
367898|NCT01074099|E1|Reported Event|Control|"CABG only~CABG only: Control subjects will undergo CABG surgery without BMAC injection"
367899|NCT01074047|B3|Baseline|Total|Total of all reporting groups
367900|NCT01074047|B2|Baseline|Conventional Care Regimens (CCR)|#1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. Consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed. # 2 Low-dose cytarabine 20 mg SC twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only includes transfusion of blood products, antibiotics, antifungals and nutritional help.
367901|NCT01074047|B1|Baseline|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367982|NCT01074008|B9|Baseline|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368633|NCT01072344|O2|Outcome|Placebo|"Pharmaceutical grade lactose monohydrate.~Chamomile (Matricaria recutita): 500 mg 3 times daily"
373598|NCT01059760|O3|Outcome|Change When Fed|
367902|NCT01074047|P2|Participant Flow|Conventional Care Regimens (CCR)|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m² QD or Idarubicin 9-12 mg/m² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
367903|NCT01074047|P1|Participant Flow|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367904|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367905|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367906|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367907|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367908|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367909|NCT01074047|O2|Outcome|Conventional Care Regimens (CCR)|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367910|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367911|NCT01074047|O2|Outcome|Conventional Care Regimens (CCR)|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367912|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367983|NCT01074008|B8|Baseline|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
369079|NCT01071252|B3|Baseline|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
367913|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367914|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367915|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367916|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367917|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367918|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367919|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367920|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367921|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367922|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367984|NCT01074008|B7|Baseline|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
367985|NCT01074008|B6|Baseline|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
367923|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367924|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367925|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367926|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367927|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367928|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367929|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367930|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367931|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367932|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367986|NCT01074008|B5|Baseline|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
367987|NCT01074008|B4|Baseline|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
367933|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367934|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367935|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367936|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367937|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367938|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367939|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367940|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367941|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367942|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367988|NCT01074008|B3|Baseline|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
367989|NCT01074008|B2|Baseline|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
367943|NCT01074047|O2|Outcome|Conventional Care Regimens (CCR)|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367944|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367945|NCT01074047|O2|Outcome|Conventional Care Regimens (CCR)|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367946|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367947|NCT01074047|O2|Outcome|Conventional Care Regimens (CCR)|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367948|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367949|NCT01074047|O2|Outcome|Conventional Care Regimens (CCR)|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367950|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367951|NCT01074047|O2|Outcome|Conventional Care Regimens (CCR)|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367952|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367990|NCT01074008|B1|Baseline|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368024|NCT01074008|O1|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
367953|NCT01074047|O4|Outcome|Conventional Care Regimen #1 Intensive Chemotherapy|Induction Therapy included Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (IV) for 7 days plus daunorubicin 45 to 60 mg/m^² daily IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV daily for 3 days as an alternative to daunorubicin (Cycle 1). Consolidation Therapy (Cycle 2 and 3) Cytarabine 100-200 mg/m^2 as a continuous IV infusion for a total of 3 to 7 days plus daunorubicin 45 to 60 mg/m^² daily or Idarubicin 9-12 mg/m^² IV daily on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from commencement of induction therapy, upon recovery of absolute neutrophil count (ANC) to at least 1.0 x 10^9/L and platelets to at least 75 x 10^9/L. The second consolidation cycle, if given, started between Day 28 and Day 70 from commencement of the first consolidation therapy. Participants could receive BSC as needed, including antibiotics and transfusions, physicians discretion.
367954|NCT01074047|O3|Outcome|Conventional Care Regimen #2 Low-dose Cytarabine|Low-dose cytarabine 20 mg SC injection twice a day (BID) for 10 days, every 28 days (optimally for at least 4 cycles) until the end of the study, unless participants were discontinued from the treatment. Best supportive care as needed, including antibiotics and transfusions, per physicians discretion.
367955|NCT01074047|O2|Outcome|Conventional Care Regimen #3 Best Supportive Care Only|Best supportive care included red blood cell (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic and/or antifungal therapy, and nutritional support.
367956|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367957|NCT01074047|O2|Outcome|Conventional Care Regimens (CCR)|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367958|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367959|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367960|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367961|NCT01074047|O2|Outcome|Conventional Care Regimens (CCR)|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367962|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367963|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367964|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
368192|NCT01073605|B2|Baseline|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
367965|NCT01074047|O2|Outcome|Conventional Care Regimens (CCR)|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367966|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367967|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367968|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367969|NCT01074047|O2|Outcome|Conventional Care Regimens (CCR)|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
367970|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367971|NCT01074047|E5|Reported Event|Azacitidine-extension|Azacitidine 75 mg/m^2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
367972|NCT01074047|E4|Reported Event|Intensive Chemotherapy|Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed
367973|NCT01074047|E3|Reported Event|Low-dose Cytarabine|Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC
367974|NCT01074047|E2|Reported Event|BSC Only|Transfusion of blood products, antibiotics, antifungals and nutritional help
367975|NCT01074047|E1|Reported Event|Azacitidine|Azacitidine 75 mg/m^2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion
367976|NCT01074034|B1|Baseline|AV Therapy Assessment Group|"AV Therapy Assessment group, Atrial ATP and Atrial Therapy Suite (ATS)~AV Therapy Assessment-B301 investigational device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device~Ventricular tachyarrhythmia rescue shock feature~AV Therapy Assessment-B301 investigational device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device"
367977|NCT01074034|P1|Participant Flow|B301 Device|B301 ASSURE Device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device
367978|NCT01074034|O1|Outcome|B301 Device|B301 ASSURE Device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device
367979|NCT01074034|O1|Outcome|AV Therapy Assessment Group|"appropriate system performance of the atrial and ventricular tachyarrhythmia therapies in the ASSURE device~AV Therapy Assessment-B301 investigational device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device"
367980|NCT01074034|E1|Reported Event|B301 Device|B301 ASSURE Device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device
367981|NCT01074008|B10|Baseline|Total|Total of all reporting groups
368023|NCT01074008|O2|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
367991|NCT01074008|P9|Participant Flow|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
367992|NCT01074008|P8|Participant Flow|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
367993|NCT01074008|P7|Participant Flow|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
367994|NCT01074008|P6|Participant Flow|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
367995|NCT01074008|P5|Participant Flow|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
367996|NCT01074008|P4|Participant Flow|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
367997|NCT01074008|P3|Participant Flow|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
367998|NCT01074008|P2|Participant Flow|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
367999|NCT01074008|P1|Participant Flow|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368000|NCT01074008|O4|Outcome|Placebo (Regardless of Dose) + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368001|NCT01074008|O3|Outcome|ABT-333 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-333 monotherapy at each dose level twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368002|NCT01074008|O2|Outcome|ABT-072 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-072 monotherapy at each dose level once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368003|NCT01074008|O1|Outcome|ABT-450/r (Regardless of Dose) + pegIFN/RBV|Participants received ABT-450 and ritonavir (r) monotherapy at each dose level once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368004|NCT01074008|O4|Outcome|Placebo (Regardless of Dose) + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368005|NCT01074008|O3|Outcome|ABT-333 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-333 monotherapy at each dose level twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368006|NCT01074008|O2|Outcome|ABT-072 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-072 monotherapy at each dose level once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368634|NCT01072344|O1|Outcome|Chamomile Extract|"Pharmaceutical grade oral chamomile extract.~Chamomile (Matricaria recutita): 500 mg 3 times daily"
368007|NCT01074008|O1|Outcome|ABT-450/r (Regardless of Dose) + pegIFN/RBV|Participants received ABT-450 and ritonavir (r) monotherapy at each dose level once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368008|NCT01074008|O4|Outcome|Placebo (Regardless of Dose) + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368009|NCT01074008|O3|Outcome|ABT-333 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-333 monotherapy at each dose level twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368010|NCT01074008|O2|Outcome|ABT-072 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-072 monotherapy at each dose level once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368011|NCT01074008|O1|Outcome|ABT-450/r (Regardless of Dose) + pegIFN/RBV|Participants received ABT-450 and ritonavir (r) monotherapy at each dose level once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368012|NCT01074008|O4|Outcome|Placebo (Regardless of Dose) + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368013|NCT01074008|O3|Outcome|ABT-333 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-333 monotherapy at each dose level twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368014|NCT01074008|O2|Outcome|ABT-072 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-072 monotherapy at each dose level once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368015|NCT01074008|O1|Outcome|ABT-450/r (Regardless of Dose) + pegIFN/RBV|Participants received ABT-450 and ritonavir (r) monotherapy at each dose level once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368016|NCT01074008|O4|Outcome|Placebo (Regardless of Dose) + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368017|NCT01074008|O3|Outcome|ABT-333 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-333 monotherapy at each dose level twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368018|NCT01074008|O2|Outcome|ABT-072 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-072 monotherapy at each dose level once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368019|NCT01074008|O1|Outcome|ABT-450/r (Regardless of Dose) + pegIFN/RBV|Participants received ABT-450 and ritonavir (r) monotherapy at each dose level once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368020|NCT01074008|O2|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368021|NCT01074008|O1|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368022|NCT01074008|O3|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368635|NCT01072344|O2|Outcome|Placebo|"Pharmaceutical grade lactose monohydrate.~Chamomile (Matricaria recutita): 500 mg 3 times daily"
373599|NCT01059760|O2|Outcome|Change While Fasting|
368025|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368026|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368027|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368028|NCT01074008|O9|Outcome|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368029|NCT01074008|O8|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368030|NCT01074008|O7|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368031|NCT01074008|O6|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368032|NCT01074008|O5|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368033|NCT01074008|O4|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368034|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368035|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368036|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368037|NCT01074008|O2|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368038|NCT01074008|O1|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368039|NCT01074008|O2|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368040|NCT01074008|O1|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368193|NCT01073605|B1|Baseline|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368041|NCT01074008|O2|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368042|NCT01074008|O1|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368043|NCT01074008|O3|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368044|NCT01074008|O2|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368045|NCT01074008|O1|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368046|NCT01074008|O3|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368047|NCT01074008|O2|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368048|NCT01074008|O1|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368049|NCT01074008|O3|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368050|NCT01074008|O2|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368051|NCT01074008|O1|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368052|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368053|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368054|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368055|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368056|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368129|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
368057|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368058|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368059|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368060|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368061|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368062|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368063|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368064|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368065|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368066|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368067|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368068|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368069|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368070|NCT01074008|O9|Outcome|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368071|NCT01074008|O8|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368072|NCT01074008|O7|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
373600|NCT01059760|O1|Outcome|Baseline Value|
368073|NCT01074008|O6|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368074|NCT01074008|O5|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368075|NCT01074008|O4|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368076|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368077|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368078|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368079|NCT01074008|O9|Outcome|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368080|NCT01074008|O8|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368081|NCT01074008|O7|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368082|NCT01074008|O6|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368083|NCT01074008|O5|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368084|NCT01074008|O4|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368085|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368086|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368087|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368088|NCT01074008|O9|Outcome|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368130|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
368089|NCT01074008|O8|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368090|NCT01074008|O7|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368091|NCT01074008|O6|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368092|NCT01074008|O5|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368093|NCT01074008|O4|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368094|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368095|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368096|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368097|NCT01074008|E9|Reported Event|Placebo + (pegIFN/RBV)|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368098|NCT01074008|E8|Reported Event|ABT-333 (800 mg) Twice Daily (BID) + (pegIFN/RBV)|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368099|NCT01074008|E7|Reported Event|ABT-333 (400 mg) Twice a Day (BID) + (pegIFN/RBV)|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368100|NCT01074008|E6|Reported Event|ABT-072 (600 mg) Once Daily (QD) + (pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368101|NCT01074008|E5|Reported Event|ABT-072 (300 mg) Once Daily (QD) + (pegIFN/RBV)|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368102|NCT01074008|E4|Reported Event|ABT-072 (100 mg) Once Daily (QD) + (pegIFN/RBV)|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368103|NCT01074008|E3|Reported Event|ABT-450/r (200/100 mg) Once Daily (QD) + (pegIFN/RBV)|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368104|NCT01074008|E2|Reported Event|ABT-450/r (100/100 mg) Once Daily (QD) + (pegIFN/RBV)|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368367|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368105|NCT01074008|E1|Reported Event|ABT-450/r (50/100 mg) Once Daily (QD) + (pegIFN/RBV)|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
368106|NCT01073943|B3|Baseline|Total|Total of all reporting groups
368107|NCT01073943|B2|Baseline|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
368108|NCT01073943|B1|Baseline|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
368109|NCT01073943|P2|Participant Flow|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
368110|NCT01073943|P1|Participant Flow|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
368111|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
368112|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
368113|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
368114|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
368115|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
368116|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
368117|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
368118|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
368119|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
368120|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
368121|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
368122|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
368123|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
368124|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
368125|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
368126|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
368127|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
368128|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
368368|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
373601|NCT01059760|O3|Outcome|Change When Fed|
368131|NCT01073943|E2|Reported Event|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
368132|NCT01073943|E1|Reported Event|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
368133|NCT01073930|B3|Baseline|Total|Total of all reporting groups
368134|NCT01073930|B2|Baseline|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
368135|NCT01073930|B1|Baseline|PICOPREP|“Split Dose” method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
368136|NCT01073930|P2|Participant Flow|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
368137|NCT01073930|P1|Participant Flow|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
368138|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
368139|NCT01073930|O1|Outcome|PICOPREP|“Split Dose” method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
368140|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
368141|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
368142|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
368143|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
368144|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
368145|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
368146|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
368147|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
368148|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
368149|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
368150|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
368151|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
368152|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
368153|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
368154|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
368155|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
368189|NCT01073618|E1|Reported Event|Vfend|Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.
368156|NCT01073930|E2|Reported Event|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
368157|NCT01073930|E1|Reported Event|PICOPREP|“Split Dose” method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
368158|NCT01073865|B3|Baseline|Total|Total of all reporting groups
368159|NCT01073865|B2|Baseline|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
368160|NCT01073865|B1|Baseline|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
368161|NCT01073865|P2|Participant Flow|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
368162|NCT01073865|P1|Participant Flow|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
368163|NCT01073865|O2|Outcome|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
368164|NCT01073865|O1|Outcome|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
368165|NCT01073865|O2|Outcome|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
368166|NCT01073865|O1|Outcome|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
368167|NCT01073865|O2|Outcome|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
368168|NCT01073865|O1|Outcome|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
368169|NCT01073865|E2|Reported Event|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
368170|NCT01073865|E1|Reported Event|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
368171|NCT01073657|B3|Baseline|Total|Total of all reporting groups
368172|NCT01073657|B2|Baseline|Active Control|Veterans recived peer services that did not address educational goals
368173|NCT01073657|B1|Baseline|Arm 1|Supported Education: Rehabilitation counseling using peers to achieve educational goals
368174|NCT01073657|P2|Participant Flow|General Peer Support|Veterans received peer services that did not address educational goals
368175|NCT01073657|P1|Participant Flow|Supported Education|Supported Education: Rehabilitation counseling using peers to achieve educational goals
368176|NCT01073657|O2|Outcome|General Peer Support|Matched peer attention no supported education service
368177|NCT01073657|O1|Outcome|Supported Education|Supported Education: Rehabilitation counseling using peers to achieve educational goals Intervention group
368178|NCT01073657|E2|Reported Event|Active Control|Veterans received matched peer attention that did not address educational goals
368179|NCT01073657|E1|Reported Event|Arm 1|Supported Education: Rehabilitation counseling using peers to achieve educational goals
368180|NCT01073631|B1|Baseline|Vfend|Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
368181|NCT01073631|P1|Participant Flow|Vfend|Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
368182|NCT01073631|O1|Outcome|Vfend|Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
368183|NCT01073631|O1|Outcome|Vfend|Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
368184|NCT01073631|E1|Reported Event|Vfend|Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
368185|NCT01073618|B1|Baseline|Vfend|Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.
368186|NCT01073618|P1|Participant Flow|Vfend|Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.
368187|NCT01073618|O1|Outcome|Vfend|Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.
368188|NCT01073618|O1|Outcome|Vfend|Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.
368190|NCT01073605|B4|Baseline|Total|Total of all reporting groups
368194|NCT01073605|P3|Participant Flow|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368195|NCT01073605|P2|Participant Flow|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368196|NCT01073605|P1|Participant Flow|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 international unit (IU)/kilogram (kg)/week (0.03 milligram [mg]/kg/day) of Genotonorm growth hormone (GH) as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368197|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368198|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368199|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368200|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368201|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368202|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368203|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368204|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368205|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368206|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368207|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368208|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368209|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368210|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368211|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368212|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368213|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368214|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368215|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368216|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368217|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368218|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368219|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368220|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368221|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368222|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368223|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368224|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368225|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368226|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368227|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368228|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368229|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368230|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368231|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368232|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368233|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368234|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368235|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368236|NCT01073605|E3|Reported Event|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368237|NCT01073605|E2|Reported Event|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368238|NCT01073605|E1|Reported Event|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 international unit (IU)/kilogram (kg)/week (0.03 milligram [mg]/kg/day) of Genotonorm growth hormone (GH) as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
368239|NCT01073566|B3|Baseline|Total|Total of all reporting groups
368240|NCT01073566|B2|Baseline|Usual Injection Device Then Finesse|Subjects in this group first used their usual pen/syringe to deliver bolus insulin for 6 weeks then switched to Finesse Patch to deliver bolus insulin for the final 6 weeks
368241|NCT01073566|B1|Baseline|Finesse Then Usual Injection Device|Subjects in this group first used Finesse Patch to deliver bolus insulin for 6 weeks then switched back to their usual pen/syringe to deliver bolus insulin for the final 6 weeks
368242|NCT01073566|P2|Participant Flow|Usual Injection Device Then Finesse|Subjects in this group first used their usual pen/syringe to deliver bolus insulin for 6 weeks then switched to Finesse Patch to deliver bolus insulin for the final 6 weeks
368243|NCT01073566|P1|Participant Flow|Finesse Then Usual Injection Device|Subjects in this group first used Finesse Patch to deliver bolus insulin for 6 weeks then switched back to their usual pen/syringe to deliver bolus insulin for the final 6 weeks
368244|NCT01073566|O2|Outcome|Usual Injection Device|Pen/Syringe
368245|NCT01073566|O1|Outcome|Finesse|Bolus Patch
368246|NCT01073566|O2|Outcome|Usual Injection Device|Pen/Syringe
368247|NCT01073566|O1|Outcome|Finesse|Bolus Patch
368248|NCT01073566|O2|Outcome|Usual Injection Device|Pen/Syringe
368249|NCT01073566|O1|Outcome|Finesse|Bolus Patch
368250|NCT01073566|O2|Outcome|Usual Injection Device|Pen/Syringe
368251|NCT01073566|O1|Outcome|Finesse|Bolus Patch
368252|NCT01073566|E2|Reported Event|Usual Injection Device|Pen/Syringe
368253|NCT01073566|E1|Reported Event|Finesse|Bolus Patch
368254|NCT01073462|B1|Baseline|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
368448|NCT01072656|B3|Baseline|Total|Total of all reporting groups
368449|NCT01072656|B2|Baseline|Sham First|sham stimulation - IPG ON, at 0 Volt
373602|NCT01059760|O2|Outcome|Change While Fasting|
368255|NCT01073462|P1|Participant Flow|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
368256|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
368257|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
368258|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
368259|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
368260|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
368261|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
368262|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
368263|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
368264|NCT01073462|E1|Reported Event|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years
368265|NCT01073449|B1|Baseline|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
368266|NCT01073449|P1|Participant Flow|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
368267|NCT01073449|O1|Outcome|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
368268|NCT01073449|O1|Outcome|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
368269|NCT01073449|O1|Outcome|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
368270|NCT01073449|E1|Reported Event|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
368271|NCT01073293|B3|Baseline|Total|Total of all reporting groups
368272|NCT01073293|B2|Baseline|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
368273|NCT01073293|B1|Baseline|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
368274|NCT01073293|P2|Participant Flow|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
368275|NCT01073293|P1|Participant Flow|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
368276|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
368277|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
368278|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
368279|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
368280|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
368281|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
368282|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
368450|NCT01072656|B1|Baseline|Active First|active stimulation programmed to the settings found to be optimal during the titration phase
368451|NCT01072656|P2|Participant Flow|Sham First|sham stimulation - IPG ON, at 0 Volt
368283|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
368284|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
368285|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
368286|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
368287|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
368288|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
368289|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
368290|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
368291|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
368292|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
368293|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
368294|NCT01073293|E2|Reported Event|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
368295|NCT01073293|E1|Reported Event|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Day 1
368296|NCT01073267|B1|Baseline|TSEBT|Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks.
368297|NCT01073267|P1|Participant Flow|TSEBT|Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks.
368298|NCT01073267|O1|Outcome|TSEBT|Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks.
368299|NCT01073267|E1|Reported Event|TSEBT|Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks.
368300|NCT01073163|B1|Baseline|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
368301|NCT01073163|P1|Participant Flow|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
368302|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
368303|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
368304|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
368305|NCT01073163|O3|Outcome|Total|All participants administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
368306|NCT01073163|O2|Outcome|Mantle Cell Lymphoma|Participants with mantle cell lymphoma were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
368307|NCT01073163|O1|Outcome|Non-Hodgkin Lymphoma|Participants with non-Hodgkin Lymphoma were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
368308|NCT01073163|O3|Outcome|Total|All participants administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
368309|NCT01073163|O2|Outcome|Mantle Cell Lymphoma|Participants with mantle cell lymphoma were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
368452|NCT01072656|P1|Participant Flow|Active First|active stimulation programmed to the settings found to be optimal during the titration phase
373603|NCT01059760|O1|Outcome|Baseline Value|
368310|NCT01073163|O1|Outcome|Non-Hodgkin Lymphoma|Participants with non-Hodgkin Lymphoma were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
368311|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
368312|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on day 1 of each 28-day cycle.
368313|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on day 1 of each 28-day cycle.
368314|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
368315|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
368316|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
368317|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
368318|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
368319|NCT01073163|E1|Reported Event|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
368320|NCT01072929|B4|Baseline|Total|Total of all reporting groups
368321|NCT01072929|B3|Baseline|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368322|NCT01072929|B2|Baseline|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368323|NCT01072929|B1|Baseline|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368324|NCT01072929|P3|Participant Flow|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368325|NCT01072929|P2|Participant Flow|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368326|NCT01072929|P1|Participant Flow|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368327|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368328|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368329|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368330|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368331|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368332|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368333|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368334|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368335|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368336|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368337|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368338|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
369080|NCT01071252|B2|Baseline|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
368339|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368340|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368341|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368342|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368343|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368344|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368345|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368346|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368347|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368348|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368349|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368350|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368351|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368352|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368353|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368354|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368355|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368356|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368357|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368358|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368359|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368360|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368361|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368362|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368363|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368364|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368365|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368366|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368636|NCT01072344|O1|Outcome|Chamomile Extract|"Pharmaceutical grade oral chamomile extract.~Chamomile (Matricaria recutita): 500 mg 3 times daily"
373604|NCT01059760|O3|Outcome|Change When Fed|
368369|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368370|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368371|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368372|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368373|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368374|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368375|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368376|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368377|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368378|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368379|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368380|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368381|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368382|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368383|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368384|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368385|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368386|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368387|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368388|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368389|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368390|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368391|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368392|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368393|NCT01072929|O3|Outcome|All Armodafinil|This arm combines participants who took 150 mg/day and those in the discontinued treatment arm who took 200 mg/day of armodafinil for 8 weeks.
368394|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368395|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368396|NCT01072929|E3|Reported Event|PLACEBO|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368397|NCT01072929|E2|Reported Event|ARMODAFINIL 200 MG|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368637|NCT01072344|O2|Outcome|Placebo|"Pharmaceutical grade lactose monohydrate.~Chamomile (Matricaria recutita): 500 mg 3 times daily"
368398|NCT01072929|E1|Reported Event|ARMODAFINIL 150 MG|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368399|NCT01072877|B6|Baseline|Total|Total of all reporting groups
368400|NCT01072877|B5|Baseline|Polidocanol Injectable Foam 2.0%|Polidocanol injectable foam2.0%
368401|NCT01072877|B4|Baseline|Polidocanol Injectable Foam 1.0%|Polidocanol injectable foam 1.0%
368402|NCT01072877|B3|Baseline|Polidocanol Injectable Foam 0.5%|Polidocanol injectable foam 0.5%
368403|NCT01072877|B2|Baseline|Polidocanol Injectable Foam 0.125%|Polidocanol injectable foam 0.125%
368404|NCT01072877|B1|Baseline|Vehicle|"Injection of vehicle comparator~Placebo Vehicle: Placebo vehicle"
368405|NCT01072877|P5|Participant Flow|Polidocanol Endovenous Microfoam 2.0%|"Polidocanol endovenous microfoam 2.0%~Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam"
368406|NCT01072877|P4|Participant Flow|Polidocanol Endovenous Microfoam 1.0%|"Polidocanol endovenous microfoam 1.0%~Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam"
368407|NCT01072877|P3|Participant Flow|Polidocanol Endovenous Microfoam 0.5%|"Polidocanol endovenous microfoam 0.5%~Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam"
368408|NCT01072877|P2|Participant Flow|Polidocanol Endovenous Microfoam 0.125%|"Polidocanol endovenous microfoam 0.125%~Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam"
368409|NCT01072877|P1|Participant Flow|Vehicle|"Injection of vehicle comparator~Placebo Vehicle: Placebo vehicle"
368410|NCT01072877|O5|Outcome|Polidocanol Injectable Foam 2.0%|Polidocanol injectable foam at a 2.0% concentration
368411|NCT01072877|O4|Outcome|Polidocanol Injectable Foam 1.0%|Polidocanol injectable foam at a 1.0% concentration
368412|NCT01072877|O3|Outcome|Polidocanol Injectable Foam 0.5%|Polidocanol injectable foam at a 0.5% concentration
368413|NCT01072877|O2|Outcome|Polidocanol Injectable Foam 0.125%|Polidocanol injectable foam at a 0.125% concentration
368414|NCT01072877|O1|Outcome|Vehicle|"Injection of vehicle~Placebo Vehicle: Placebo vehicle"
368415|NCT01072877|O5|Outcome|Polidocanol Injectable Foam 2.0%|Polidocanol injectable foam at a 2.0% concentration
368416|NCT01072877|O4|Outcome|Polidocanol Injectable Foam 1.0%|Polidocanol injectable foam at a 1.0% concentration
368417|NCT01072877|O3|Outcome|Polidocanol Injectable Foam 0.5%|Polidocanol injectable foam at a 0.5% concentration
368418|NCT01072877|O2|Outcome|Polidocanol Injectable Foam 0.125%|Polidocanol injectable foam at a 0.125% concentration
368419|NCT01072877|O1|Outcome|Vehicle|"Injection of vehicle~Placebo Vehicle: Placebo vehicle"
368420|NCT01072877|O5|Outcome|Polidocanol Injectable Foam 2.0%|Polidocanol injectable foam at a 2.0% concentration
368421|NCT01072877|O4|Outcome|Polidocanol Injectable Foam 1.0%|Polidocanol injectable foam at 1.0% concentration
368422|NCT01072877|O3|Outcome|Polidocanol Injectable Foam 0.5%|polidocanol injectable foam at a 0.5% concentration
368423|NCT01072877|O2|Outcome|Polidocanol Injectable Foam 0.125%|Polidocanol injectable foam at a 0.125% concentration
368424|NCT01072877|O1|Outcome|Vehicle|"Injection of vehicle~Placebo Vehicle: Placebo vehicle"
368425|NCT01072877|E5|Reported Event|Polidocanol Endovenous Microfoam 2.0%|polidocanol injectable foam at a 2.0% concentration
368426|NCT01072877|E4|Reported Event|Polidocanol Injectable Foam 1.0%|polidocanol injectable foam at a 1.0% concentration
368427|NCT01072877|E3|Reported Event|Polidcanol Injectable Foam 0.5%|polidocanol injectable foam at a 0.5% concentration
368428|NCT01072877|E2|Reported Event|Polidocanol Injectable Foam 0.125%|polidocanol injectable foam at a 0.125% concentration
368429|NCT01072877|E1|Reported Event|Vehicle|"Injection of vehicle~Placebo Vehicle: Placebo vehicle"
368430|NCT01072773|B1|Baseline|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
368431|NCT01072773|P1|Participant Flow|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
368432|NCT01072773|O1|Outcome|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
368433|NCT01072773|O1|Outcome|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
368434|NCT01072773|O1|Outcome|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
368435|NCT01072773|O1|Outcome|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
368436|NCT01072773|O1|Outcome|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
368437|NCT01072773|O1|Outcome|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
368438|NCT01072773|E1|Reported Event|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
368439|NCT01072669|B3|Baseline|Total|Total of all reporting groups
368440|NCT01072669|B2|Baseline|Sugar Pill|those getting sugar pill to evaluate if the active drug improves digital microvascular flow in limited scleroderma patients
368441|NCT01072669|B1|Baseline|Ambrisentan|"drug arm~use of ambrisentan in limited scleroderma patients with raynaud's to evaluate digital microvascular flow"
368442|NCT01072669|P2|Participant Flow|Sugar Pill|those getting sugar pill to evaluate if the active drug improves digital microvascular flow in limited scleroderma patients
368443|NCT01072669|P1|Participant Flow|Ambrisentan|"drug arm~use of ambrisentan in limited scleroderma patients with raynaud's to evaluate digital microvascular flow"
368444|NCT01072669|O2|Outcome|Sugar Pill|Placebo, same appearing as Ambrisentan
368445|NCT01072669|O1|Outcome|Ambrisentan|Ambrisentan 5 mg daily for 1 month, then 10 mg daily for 2 months
368446|NCT01072669|E2|Reported Event|Sugar Pill|those getting sugar pill to evaluate if the active drug improves digital microvascular flow in limited scleroderma patients
368447|NCT01072669|E1|Reported Event|Ambrisentan|"drug arm~use of ambrisentan in limited scleroderma patients with raynaud's to evaluate digital microvascular flow"
368453|NCT01072656|O1|Outcome|Active Stimulation|"Active stimulation and programmed to the settings found to be optimal during the titration process.~Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
368454|NCT01072656|O1|Outcome|Active Stimulation|"Active stimulation and programmed to the settings found to be optimal during the titration process.~Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
368455|NCT01072656|O1|Outcome|Active Stimulation|"Active stimulation and programmed to the settings found to be optimal during the titration process.~Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
368456|NCT01072656|O2|Outcome|Sham Stimulation|"IPG is set to ON but the voltage is set to 0V.~Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
368457|NCT01072656|O1|Outcome|Active Stimulation|"Active stimulation and programmed to the settings found to be optimal during the titration process.~Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
368458|NCT01072656|E3|Reported Event|Phase I-IV|Phase I-IV is time frame of patient consent through surgery just prior to beginning Active v Sham Stimulation Phase.
368459|NCT01072656|E2|Reported Event|Sham Stimulation (Phase V)|"IPG is set to ON but the voltage is set to 0V.~Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
368460|NCT01072656|E1|Reported Event|Active Stimulation (Phase V)|"Active stimulation and programmed to the settings found to be optimal during the titration process.~Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
368461|NCT01072643|B1|Baseline|Dexmedetomidine|"To study safety of DEX with regard to effect on PVR; There will be 3 study groups (n=8 per group). The groups will be based on DEX doses as follows- Group 1 - Bolus 1 mcg/kg followed by infusion 0.7 mcg/kg/hr Group 2 - Bolus 1.5 mcg/kg followed by infusion 1.05 mcg/kg/hr Group 3 - Bolus 2 mcg/kg followed by infusion 1.4 mcg/kg/hr~Dexmedetomidine: This is a single center, dose escalation study of Dexmedetomidine in pediatric subjects with pulmonary hypertension (PVR>4WU) undergoing hemodynamic cardiac catheterization and vasoreactivity drug testing. Cohorts of 8 evaluable subjects will receive dose level 1, dose level 2, or dose level 3 of Dexmedetomidine."
368490|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
369081|NCT01071252|B1|Baseline|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
368462|NCT01072643|P1|Participant Flow|Dexmedetomidine 1 mcg/kg Bolus|"To study safety of DEX with regard to effect on PVR; There will be 3 study groups (n=8 per group). The groups will be based on DEX doses as follows- Group 1 - Bolus 1 mcg/kg followed by infusion 0.7 mcg/kg/hr Group 2 - Bolus 1.5 mcg/kg followed by infusion 1.05 mcg/kg/hr Group 3 - Bolus 2 mcg/kg followed by infusion 1.4 mcg/kg/hr~Dexmedetomidine: This is a single center, dose escalation study of Dexmedetomidine in pediatric subjects with pulmonary hypertension (PVR>4WU) undergoing hemodynamic cardiac catheterization and vasoreactivity drug testing. Cohorts of 8 evaluable subjects will receive dose level 1, dose level 2, or dose level 3 of Dexmedetomidine."
368463|NCT01072643|O4|Outcome|Subject 4|Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization
368464|NCT01072643|O3|Outcome|Subject 3|Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization
368465|NCT01072643|O2|Outcome|Subject 2|Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization
368466|NCT01072643|O1|Outcome|Subject 1|Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization
368467|NCT01072643|E1|Reported Event|Dexmedetomidine|"To study safety of DEX with regard to effect on PVR; There will be 3 study groups (n=8 per group). The groups will be based on DEX doses as follows- Group 1 - Bolus 1 mcg/kg followed by infusion 0.7 mcg/kg/hr Group 2 - Bolus 1.5 mcg/kg followed by infusion 1.05 mcg/kg/hr Group 3 - Bolus 2 mcg/kg followed by infusion 1.4 mcg/kg/hr~Dexmedetomidine: This is a single center, dose escalation study of Dexmedetomidine in pediatric subjects with pulmonary hypertension (PVR>4WU) undergoing hemodynamic cardiac catheterization and vasoreactivity drug testing. Cohorts of 8 evaluable subjects will receive dose level 1, dose level 2, or dose level 3 of Dexmedetomidine."
368468|NCT01072630|B4|Baseline|Total|Total of all reporting groups
368469|NCT01072630|B3|Baseline|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368470|NCT01072630|B2|Baseline|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368471|NCT01072630|B1|Baseline|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368472|NCT01072630|P3|Participant Flow|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368473|NCT01072630|P2|Participant Flow|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368474|NCT01072630|P1|Participant Flow|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368475|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368476|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368477|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368478|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368479|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368480|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368481|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368482|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368483|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368484|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368485|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368486|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368487|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368488|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368489|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368493|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368494|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368495|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368496|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368497|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368498|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368499|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368500|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368501|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368502|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368503|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368504|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368505|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368506|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368507|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368508|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368509|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368510|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368511|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368512|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368513|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368514|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368515|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368516|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368517|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368518|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368519|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368520|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368638|NCT01072344|O1|Outcome|Chamomile Extract|"Pharmaceutical grade oral chamomile extract.~Chamomile (Matricaria recutita): 500 mg 3 times daily"
373605|NCT01059760|O2|Outcome|Change While Fasting|
368521|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368522|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368523|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368524|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368525|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368526|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368527|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368528|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368529|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368530|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368531|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368532|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368533|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368534|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368535|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368536|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368537|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368538|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368539|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368540|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368541|NCT01072630|O3|Outcome|All Armodafinil|This arm combines participants who took 150 mg/day and those in the discontinued treatment arm who took 200 mg/day of armodafinil for 8 weeks.
368542|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368543|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368544|NCT01072630|E3|Reported Event|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
368545|NCT01072630|E2|Reported Event|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
368546|NCT01072630|E1|Reported Event|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
368547|NCT01072617|B1|Baseline|Safety of rTMS in Schizophrenia Patients|"Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days~Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.~Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
368639|NCT01072344|O2|Outcome|Placebo|"Pharmaceutical grade lactose monohydrate.~Chamomile (Matricaria recutita): 500 mg 3 times daily"
373606|NCT01059760|O1|Outcome|Baseline Value|
368548|NCT01072617|P1|Participant Flow|Safety of rTMS in Schizophrenia Patients|"Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days~Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.~Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
368549|NCT01072617|O1|Outcome|Safety of rTMS in Schizophrenia Patients|"Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.~Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
368550|NCT01072617|O1|Outcome|Safety of rTMS in Schizophrenia Patients|"Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.~Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
368551|NCT01072617|O1|Outcome|Safety of rTMS in Schizophrenia Patients|"Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.~Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
368552|NCT01072617|O1|Outcome|Safety of rTMS in Schizophrenia Patients|"Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days~Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.~Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
368553|NCT01072617|E1|Reported Event|Safety of rTMS in Schizophrenia Patients|"Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days~Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.~Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
368554|NCT01072539|B1|Baseline|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
368555|NCT01072539|P1|Participant Flow|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
368556|NCT01072539|O1|Outcome|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
368557|NCT01072539|O1|Outcome|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
368558|NCT01072539|O1|Outcome|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
368559|NCT01072539|O1|Outcome|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
368560|NCT01072539|O1|Outcome|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
368561|NCT01072539|E1|Reported Event|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
368562|NCT01072526|B1|Baseline|2 Arm Study - Description Below|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis)euphrasia based homeopathic therapy and cyclosporin : ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
369229|NCT01071044|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate 30, 50, 70 mg
368563|NCT01072526|P2|Participant Flow|Control|Cyclosporin (Restasis)ophthalmic solution; 1 drop both eyes twice daily plus placebo solution. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
368564|NCT01072526|P1|Participant Flow|Intervention|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
368565|NCT01072526|O2|Outcome|Control|"Subjects will receive placebo in combination with cyclosporin (Restasis) solution.~Cyclosporin solution: Ophthalmic solution; 1 drop both eyes twice daily"
368566|NCT01072526|O1|Outcome|Intervention|"Subjects will receive Euphrasia-based homeopathic therapy (Artificial Tears) in combination with cyclosporin (Restasis) solution.~Euphrasia-based homeopathic therapy: ophthalmic solution; 1 drop both eyes twice daily~Cyclosporin solution: Ophthalmic solution; 1 drop both eyes twice daily"
368567|NCT01072526|O2|Outcome|Control|cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
368568|NCT01072526|O1|Outcome|Intervention|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
368569|NCT01072526|O2|Outcome|Control|cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
368570|NCT01072526|O1|Outcome|Intervention|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
368571|NCT01072526|O2|Outcome|Control|cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
368572|NCT01072526|O1|Outcome|Intervention|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
368573|NCT01072526|O2|Outcome|Control|cyclosporin ophthalmic solution plus placebo solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
368574|NCT01072526|O1|Outcome|Intervention|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
368575|NCT01072526|E1|Reported Event|2 Arm Study - Description Below|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis)euphrasia based homeopathic therapy and cyclosporin : ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
368576|NCT01072500|B3|Baseline|Total|Total of all reporting groups
368577|NCT01072500|B2|Baseline|Successful Aging|The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
368578|NCT01072500|B1|Baseline|Physical Activity|The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
368579|NCT01072500|P2|Participant Flow|Successful Aging (Health Education)|The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
368580|NCT01072500|P1|Participant Flow|Physical Activity|The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
368581|NCT01072500|O2|Outcome|Successful Aging|"The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.~Successful Aging: The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises."
368582|NCT01072500|O1|Outcome|Physical Activity|"The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.~Physical Activity: The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling."
368583|NCT01072500|O2|Outcome|Successful Aging|The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
368584|NCT01072500|O1|Outcome|Physical Activity|The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
368585|NCT01072500|E2|Reported Event|Successful Aging|The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
368586|NCT01072500|E1|Reported Event|Physical Activity|The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
368587|NCT01072448|B3|Baseline|Total|Total of all reporting groups
369230|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50 or 70 mg"
368588|NCT01072448|B2|Baseline|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
368589|NCT01072448|B1|Baseline|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
368590|NCT01072448|P2|Participant Flow|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
368591|NCT01072448|P1|Participant Flow|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
368592|NCT01072448|O2|Outcome|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
368593|NCT01072448|O1|Outcome|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
368594|NCT01072448|O2|Outcome|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
368595|NCT01072448|O1|Outcome|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
368596|NCT01072448|E2|Reported Event|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
368597|NCT01072448|E1|Reported Event|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
368598|NCT01072409|B1|Baseline|Implanted|Subjects who met study inclusion and completed the primary endpoint.
368599|NCT01072409|P1|Participant Flow|Implanted|Subjects who met study inclusion and completed the primary endpoint.
368600|NCT01072409|O1|Outcome|Implanted|Subjects who met study inclusion and completed the primary endpoint.
368601|NCT01072409|E1|Reported Event|Implanted|Subjects who met study inclusion and completed the primary endpoint.
368602|NCT01072396|B3|Baseline|Total|Total of all reporting groups
368603|NCT01072396|B2|Baseline|Tiotropium/Placebo|Patients were randomized to receive treatment with Tiotropium 18 micrograms for six weeks followed by treatment with placebo for six weeks
368604|NCT01072396|B1|Baseline|Placebo/Tiotropium|Patients were randomized to receive treatment with Placebo for six weeks followed by treatment with Tiotropium 18 micrograms for six weeks
368605|NCT01072396|P2|Participant Flow|Tiotropium/Placebo|Patients were randomized to receive treatment with Tiotropium 18 micrograms for six weeks followed by treatment with placebo for six weeks
368606|NCT01072396|P1|Participant Flow|Placebo/Tiotropium|Patients were randomized to receive treatment with Placebo for six weeks followed by treatment with Tiotropium 18 micrograms for six weeks
368607|NCT01072396|O2|Outcome|Tiotropium|Patients who received tiotropium in period one or period two
368608|NCT01072396|O1|Outcome|Placebo|Patients who received placebo in period one or period two
368609|NCT01072396|O2|Outcome|Tiotropium|Patients who received tiotropium in period one or period two
368610|NCT01072396|O1|Outcome|Placebo|Patients who received placebo in period one or period two
368611|NCT01072396|O2|Outcome|Tiotropium|Patients who received tiotropium in period one or period two
368612|NCT01072396|O1|Outcome|Placebo|Patients who received placebo in period one or period two
368613|NCT01072396|E2|Reported Event|Tiotropium|Patients who received tiotropium in period one or period two
368614|NCT01072396|E1|Reported Event|Placebo|Patients who received placebo in period one or period two
368615|NCT01072357|B3|Baseline|Total|Total of all reporting groups
368616|NCT01072357|B2|Baseline|0.9% NaCl & Refresh Liquigel|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% sodium chloride (NaCl). Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~0.9% NaCl & Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks"
368640|NCT01072344|O1|Outcome|Chamomile Extract|"Pharmaceutical grade oral chamomile extract.~Chamomile (Matricaria recutita): 500 mg 3 times daily"
369231|NCT01071044|O1|Outcome|Treatment Group|Lisdexamfetamine Dimesylate 30, 50 or 70 mg
368617|NCT01072357|B1|Baseline|Avastin® (Bevacizumab)|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 milliliter (mL) (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks."
368618|NCT01072357|P2|Participant Flow|0.9% NaCl & Refresh Liquigel|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% sodium chloride (NaCl). Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~0.9% NaCl & Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks"
368619|NCT01072357|P1|Participant Flow|Avastin® (Bevacizumab)|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 milliliter (mL) (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks."
368620|NCT01072357|O2|Outcome|0.9% NaCl & Refresh Liquigel|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% sodium chloride (NaCl). Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~0.9% NaCl & Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks"
368621|NCT01072357|O1|Outcome|Avastin® (Bevacizumab)|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 milliliter (mL) (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks."
368622|NCT01072357|O2|Outcome|0.9% NaCl & Refresh Liquigel|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% sodium chloride (NaCl). Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~0.9% NaCl & Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks"
368623|NCT01072357|O1|Outcome|Avastin® (Bevacizumab)|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 milliliter (mL) (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks."
368624|NCT01072357|E2|Reported Event|0.9% NaCl & Refresh Liquigel|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% sodium chloride (NaCl). Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~0.9% NaCl & Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks"
368625|NCT01072357|E1|Reported Event|Avastin® (Bevacizumab)|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 milliliter (mL) (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks."
368626|NCT01072344|B3|Baseline|Total|Total of all reporting groups
368627|NCT01072344|B2|Baseline|Placebo|"Pharmaceutical grade lactose monohydrate.~Chamomile (Matricaria recutita): 500 mg 3 times daily"
368628|NCT01072344|B1|Baseline|Chamomile Extract|"Pharmaceutical grade oral chamomile extract.~Chamomile (Matricaria recutita): 500 mg 3 times daily"
368629|NCT01072344|P2|Participant Flow|Placebo|"Pharmaceutical grade lactose monohydrate.~Chamomile (Matricaria recutita): 500 mg 3 times daily"
368630|NCT01072344|P1|Participant Flow|Chamomile Extract|"Pharmaceutical grade oral chamomile extract.~Chamomile (Matricaria recutita): 500 mg 3 times daily"
368631|NCT01072344|O2|Outcome|Placebo|"Pharmaceutical grade lactose monohydrate.~Chamomile (Matricaria recutita): 500 mg 3 times daily"
368641|NCT01072344|E2|Reported Event|Placebo|"Pharmaceutical grade lactose monohydrate.~Chamomile (Matricaria recutita): 500 mg 3 times daily"
368642|NCT01072344|E1|Reported Event|Chamomile Extract|"Pharmaceutical grade oral chamomile extract.~Chamomile (Matricaria recutita): 500 mg 3 times daily"
368643|NCT01072331|B4|Baseline|Total|Total of all reporting groups
368644|NCT01072331|B3|Baseline|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
368645|NCT01072331|B2|Baseline|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
368646|NCT01072331|B1|Baseline|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
368647|NCT01072331|P3|Participant Flow|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
368648|NCT01072331|P2|Participant Flow|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
368649|NCT01072331|P1|Participant Flow|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
368650|NCT01072331|O3|Outcome|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
368651|NCT01072331|O2|Outcome|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
368652|NCT01072331|O1|Outcome|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
368653|NCT01072331|O3|Outcome|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
368654|NCT01072331|O2|Outcome|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
368655|NCT01072331|O1|Outcome|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
368656|NCT01072331|O3|Outcome|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
368657|NCT01072331|O2|Outcome|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
368658|NCT01072331|O1|Outcome|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
368659|NCT01072331|O3|Outcome|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
368660|NCT01072331|O2|Outcome|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
368661|NCT01072331|O1|Outcome|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
368662|NCT01072331|E3|Reported Event|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
368663|NCT01072331|E2|Reported Event|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
368664|NCT01072331|E1|Reported Event|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
368665|NCT01072201|B3|Baseline|Total|Total of all reporting groups
368666|NCT01072201|B2|Baseline|Ultrabrite Toothpaste|sodium fluoride control (placebo)
368667|NCT01072201|B1|Baseline|Total Toothpaste|Triclosan/copolymer/Fluoride
368668|NCT01072201|P2|Participant Flow|Ultrabrite Toothpaste|sodium fluoride control(placebo)
368669|NCT01072201|P1|Participant Flow|Total Toothpaste|Triclosan/copolymer/Fluoride
368670|NCT01072201|O2|Outcome|Ultrabrite Toothpaste|sodium fluoride control (placebo)
368671|NCT01072201|O1|Outcome|Total Toothpaste|Triclosan/copolymer/Fluoride
368672|NCT01072201|O2|Outcome|Ultrabrite Toothpaste|sodium fluoride control (placebo)
368673|NCT01072201|O1|Outcome|Total Toothpaste|Triclosan/copolymer/Fluoride
368674|NCT01072201|O2|Outcome|Ultrabrite Toothpaste|sodium fluoride control (placebo)
368675|NCT01072201|O1|Outcome|Total Toothpaste|Triclosan/copolymer/Fluoride
368676|NCT01072201|E2|Reported Event|Ultrabrite Toothpaste|sodium fluoride control (placebo)
368677|NCT01072201|E1|Reported Event|Total Toothpaste|Triclosan/copolymer/Fluoride
368678|NCT01072188|B3|Baseline|Total|Total of all reporting groups
368679|NCT01072188|B2|Baseline|Nupro-M Prophylaxis Paste-B|Control prophy paste (Fluoride free).
368680|NCT01072188|B1|Baseline|ProClude Prophylaxis Paste-A|Arginine Bicarbonate prophy paste (experimental).
368681|NCT01072188|P2|Participant Flow|Nupro-M Prophylaxis Paste-B|Control prophy paste (Fluoride free).
368682|NCT01072188|P1|Participant Flow|ProClude Prophylaxis Paste-A|Arginine Bicarbonate prophy paste (experimental).
368683|NCT01072188|O2|Outcome|Nupro-M Prophylaxis Paste-B|Control prophy paste (Fluoride free).
368684|NCT01072188|O1|Outcome|ProClude Prophylaxis Paste-A|Arginine Bicarbonate prophy paste (experimental).
368685|NCT01072188|O2|Outcome|Nupro-M Prophylaxis Paste-B|Control prophy paste (Fluoride free).
368686|NCT01072188|O1|Outcome|ProClude Prophylaxis Paste-A|Arginine Bicarbonate prophy paste (experimental).
368687|NCT01072188|E2|Reported Event|Nupro-M Prophylaxis Paste-B|Control prophy paste (Fluoride free).
368688|NCT01072188|E1|Reported Event|ProClude Prophylaxis Paste-A|Arginine Bicarbonate prophy paste (experimental).
368689|NCT01072175|B13|Baseline|Total|Total of all reporting groups
368690|NCT01072175|B12|Baseline|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368691|NCT01072175|B11|Baseline|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrafenib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368692|NCT01072175|B10|Baseline|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368693|NCT01072175|B9|Baseline|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrafenib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368694|NCT01072175|B8|Baseline|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
368695|NCT01072175|B7|Baseline|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
368696|NCT01072175|B6|Baseline|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
368697|NCT01072175|B5|Baseline|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
369082|NCT01071252|P5|Participant Flow|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
368698|NCT01072175|B4|Baseline|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368699|NCT01072175|B3|Baseline|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368700|NCT01072175|B2|Baseline|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
368701|NCT01072175|B1|Baseline|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
368702|NCT01072175|P13|Participant Flow|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368703|NCT01072175|P12|Participant Flow|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrafenib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368704|NCT01072175|P11|Participant Flow|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368705|NCT01072175|P10|Participant Flow|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrafenib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368706|NCT01072175|P9|Participant Flow|Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg|Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.
368707|NCT01072175|P8|Participant Flow|Part C (Randomized): Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
368708|NCT01072175|P7|Participant Flow|Part C (Randomized): Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
368709|NCT01072175|P6|Participant Flow|Part C (Randomized): Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
368710|NCT01072175|P5|Participant Flow|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
368711|NCT01072175|P4|Participant Flow|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368712|NCT01072175|P3|Participant Flow|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368713|NCT01072175|P2|Participant Flow|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
368714|NCT01072175|P1|Participant Flow|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
368715|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368716|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrafenib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368717|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368718|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrafenib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368719|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
369083|NCT01071252|P4|Participant Flow|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
368720|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrafenib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368721|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368722|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrafenib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368723|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368724|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrafenib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368725|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368726|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrafenib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368727|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368728|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrafenib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368729|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368730|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrafenib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368731|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368732|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368733|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368734|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368735|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368736|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368737|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368738|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368739|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368740|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrafenib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368741|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368742|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrafenib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368743|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368744|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrafenib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368745|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368746|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrafenib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368747|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368748|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368749|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368750|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368751|NCT01072175|O2|Outcome|Part C: Trametinib|Participants received Trametinib 1 mg or 2 mg tablets QD.
368752|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
368753|NCT01072175|O2|Outcome|Part C: Trametinib|Participants received Trametinib 1 mg or 2 mg tablets QD.
368754|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
368755|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
368756|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
368757|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
368758|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
368759|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
368760|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
368761|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
368762|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
368763|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
368764|NCT01072175|O1|Outcome|Part B: Dabrafenib + Trametinib|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib (75 mg or 150 mg) gelatin capsules BID and trametinib (1 mg, 1.5 mg, or 2 mg) tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
368765|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
368766|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368767|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368768|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
368769|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
368770|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368771|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368827|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrafenib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
369084|NCT01071252|P3|Participant Flow|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
369232|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50 or 70 mg"
368772|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
368773|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
368774|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368775|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368776|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
368777|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
368778|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368779|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368780|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
368781|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
368782|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368783|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368784|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
368785|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
368786|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368787|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368788|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
368789|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
368790|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368791|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368792|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
368793|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
368794|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368795|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368796|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
368797|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
368798|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368799|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368800|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
368801|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
368802|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368803|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368804|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
368805|NCT01072175|O1|Outcome|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
368806|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368807|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrafenib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368808|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368809|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368810|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368811|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368812|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368813|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368814|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368815|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrafenib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368816|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368817|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrafenib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368818|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368819|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368820|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368821|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368822|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368823|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrafenib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368824|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368825|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrafenib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368826|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
373607|NCT01059760|O3|Outcome|Change When Fed|
368828|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368829|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrafenib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368830|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368831|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368832|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368833|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368834|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
368835|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
368836|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
368837|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
368838|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
368839|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
368840|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
368841|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
368842|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
368843|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
368844|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
368845|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
368846|NCT01072175|O1|Outcome|Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg|Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.
368847|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
368848|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
368849|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
368850|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
368851|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
368852|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
368853|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
368854|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
368855|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
368856|NCT01072175|O1|Outcome|Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg|Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.
368857|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
368858|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
368859|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
368860|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
368861|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
368862|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
368863|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
368864|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368865|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368866|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
368867|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
368868|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368869|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368870|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
368871|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
368872|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368873|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368874|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
368875|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
368876|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368877|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368901|NCT01072149|P14|Participant Flow|Sequence 14: FF/VI 200/25 µg, FF/VI 100/25 µg, Placebo|Participants self-administered FF/VI 200/25 µg, FF/VI 100/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
373608|NCT01059760|O2|Outcome|Change While Fasting|
368878|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
368879|NCT01072175|O2|Outcome|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
368880|NCT01072175|O1|Outcome|Part A: Dabrafenib 75 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
368881|NCT01072175|O2|Outcome|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
368882|NCT01072175|O1|Outcome|Part A: Dabrafenib 75 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
368883|NCT01072175|E13|Reported Event|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368884|NCT01072175|E12|Reported Event|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
368885|NCT01072175|E11|Reported Event|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368886|NCT01072175|E10|Reported Event|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
368887|NCT01072175|E9|Reported Event|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
368888|NCT01072175|E8|Reported Event|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
368889|NCT01072175|E7|Reported Event|Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg|Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.
368890|NCT01072175|E6|Reported Event|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
368891|NCT01072175|E5|Reported Event|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
368892|NCT01072175|E4|Reported Event|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368893|NCT01072175|E3|Reported Event|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
368894|NCT01072175|E2|Reported Event|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
368895|NCT01072175|E1|Reported Event|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
368896|NCT01072149|B1|Baseline|Entire Study Population|All participants who self-administered placebo, FF/VI 50/25 µg, FF/VI 100/25 µg, or FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI in any of the three 28-day treatment periods.
368897|NCT01072149|P18|Participant Flow|Sequence 18: FF/VI 100/25 µg, Placebo, FF/VI 200/25 µg|Participants self-administered FF/VI 100/25 µg, placebo, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
368898|NCT01072149|P17|Participant Flow|Sequence 17: FF/VI 50/25 µg, Placebo, FF/VI 200/25 µg|Participants self-administered FF/VI 50/25 µg, placebo, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
368899|NCT01072149|P16|Participant Flow|Sequence 16: Placebo, FF/VI 50/25 µg, FF/VI 200/25 µg|Participants self-administered placebo, FF/VI 50/25 µg, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
368900|NCT01072149|P15|Participant Flow|Sequence 15: FF/VI 100/25 µg, FF/VI 200/25 µg, Placebo|Participants self-administered FF/VI 100/25 µg, FF/VI 200/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
369085|NCT01071252|P2|Participant Flow|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
369086|NCT01071252|P1|Participant Flow|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
368902|NCT01072149|P13|Participant Flow|Sequence 13: Placebo, FF/VI 100/25 µg, FF/VI 200/25 µg|Participants self-administered placebo, FF/VI 100/25 µg, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
368903|NCT01072149|P12|Participant Flow|Sequence 12: Placebo, FF/VI 200/25 µg, FF/VI 50/25 µg|Participants self-administered placebo, FF/VI 200/25 µg, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
368904|NCT01072149|P11|Participant Flow|Sequence 11: Placebo, FF/VI 200/25 µg, FF/VI 100/25 µg|Participants self-administered placebo, FF/VI 200/25 µg, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
368905|NCT01072149|P10|Participant Flow|Sequence 10: FF/VI 100/25 µg, Placebo, FF/VI 50/25 µg|Participants self-administered FF/VI 100/25 µg, placebo, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
368906|NCT01072149|P9|Participant Flow|Sequence 9: FF/VI 100/25 µg, FF/VI 50/25 µg, Placebo|Participants self-administered FF/VI 100/25 µg, FF/VI 50/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
368907|NCT01072149|P8|Participant Flow|Sequence 8: Placebo, FF/VI 50/25 µg, FF/VI 100/25 µg|Participants self-administered placebo, FF/VI 50/25 µg, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
368908|NCT01072149|P7|Participant Flow|Sequence 7: FF/VI 200/25 µg, Placebo, FF/VI 50/25 µg|Participants self-administered FF/VI 200/25 µg, placebo, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
368909|NCT01072149|P6|Participant Flow|Sequence 6: FF/VI 50/25 µg, FF/VI 200/25 µg, Placebo|Participants self-administered FF/VI 50/25 µg, FF/VI 200/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
368910|NCT01072149|P5|Participant Flow|Sequence 5: FF/VI 50/25 µg, FF/VI 100/25 µg, Placebo|Participants self-administered FF/VI 50/25 µg, FF/VI 100/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
368911|NCT01072149|P4|Participant Flow|Sequence 4: FF/VI 200/25 µg, Placebo, and FF/VI 100/25 µg|Participants self-administered FF/VI 200/25 µg, placebo, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
368912|NCT01072149|P3|Participant Flow|Sequence 3: FF/VI 200/25 µg, FF/VI 50/25 µg, Placebo|Participants self-administered FF/VI 200/25 µg, FF/VI 50/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
368913|NCT01072149|P2|Participant Flow|Sequence 2: Placebo, FF/VI 100/25 µg, FF/VI 50/25 µg|Participants self-administered placebo, FF/VI 100/25 µg, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
368914|NCT01072149|P1|Participant Flow|Sequence 1: FF/VI 50/25 µg, Placebo, FF/VI 100/25 µg|Participants self-administered fluticasone furoate/vilanterol (FF/VI) 50/25 µg, placebo, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
368915|NCT01072149|O4|Outcome|FF/VI 200/25 µg|Participants self-administered FF 200 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
368916|NCT01072149|O3|Outcome|FF/VI 100/25 µg|Participants self-administered FF 100 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
368917|NCT01072149|O2|Outcome|FF/VI 50/25 µg|Participants self-administered Fluticasone Furoate (FF) 50 micrograms (µg) and Vilanterol (VI) 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
368918|NCT01072149|O1|Outcome|Placebo|Participants self-administered placebo once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during one of the three 28-day treatment periods.
368919|NCT01072149|O4|Outcome|FF/VI 200/25 µg|Participants self-administered FF 200 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
368920|NCT01072149|O3|Outcome|FF/VI 100/25 µg|Participants self-administered FF 100 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
368921|NCT01072149|O2|Outcome|FF/VI 50/25 µg|Participants self-administered Fluticasone Furoate (FF) 50 micrograms (µg) and Vilanterol (VI) 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
368922|NCT01072149|O1|Outcome|Placebo|Participants self-administered placebo once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during one of the three 28-day treatment periods.
368923|NCT01072149|O4|Outcome|FF/VI 200/25 µg|Participants self-administered FF 200 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
368924|NCT01072149|O3|Outcome|FF/VI 100/25 µg|Participants self-administered FF 100 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
369233|NCT01071044|O1|Outcome|Treatment Group|Lisdexamfetamine Dimesylate 30, 50 or 70 mg
368925|NCT01072149|O2|Outcome|FF/VI 50/25 µg|Participants self-administered Fluticasone Furoate (FF) 50 micrograms (µg) and Vilanterol (VI) 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
368926|NCT01072149|O1|Outcome|Placebo|Participants self-administered placebo once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during one of the three 28-day treatment periods.
368927|NCT01072149|E4|Reported Event|FF/VI 200/25 µg|Participants self-administered FF 200 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
368928|NCT01072149|E3|Reported Event|FF/VI 100/25 µg|Participants self-administered FF 100 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
368929|NCT01072149|E2|Reported Event|FF/VI 50/25 µg|Participants self-administered Fluticasone Furoate (FF) 50 micrograms (µg) and Vilanterol (VI) 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
368930|NCT01072149|E1|Reported Event|Placebo|Participants self-administered placebo once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during one of the three 28-day treatment periods.
368931|NCT01072136|B3|Baseline|Total|Total of all reporting groups
368932|NCT01072136|B2|Baseline|Placebo|Placebo
368933|NCT01072136|B1|Baseline|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
368934|NCT01072136|P2|Participant Flow|Placebo|Placebo
368935|NCT01072136|P1|Participant Flow|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
368936|NCT01072136|O2|Outcome|Placebo|Placebo
368937|NCT01072136|O1|Outcome|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
368938|NCT01072136|O2|Outcome|Placebo|Placebo
368939|NCT01072136|O1|Outcome|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
368940|NCT01072136|O2|Outcome|Placebo|Placebo
368941|NCT01072136|O1|Outcome|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
368942|NCT01072136|O3|Outcome|Clinical Cure|Clinical Cure for mucopurulent cervicitis
368943|NCT01072136|O2|Outcome|Partial Response|Partial response for mucopurulent cervicitis
368944|NCT01072136|O1|Outcome|Clinical Failure|Clinical failure for mucopurulent cervicitis
368945|NCT01072136|O3|Outcome|Clinical Cure|Clinical Cure for mucopurulent cervicitis
368946|NCT01072136|O2|Outcome|Partial Response|Partial response for mucopurulent cervicitis
368947|NCT01072136|O1|Outcome|Clinical Failure|Clinical failure for mucopurulent cervicitis
368948|NCT01072136|O2|Outcome|Placebo|Placebo
368949|NCT01072136|O1|Outcome|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
368950|NCT01072136|O2|Outcome|Placebo|Placebo
368951|NCT01072136|O1|Outcome|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
368952|NCT01072136|O2|Outcome|Placebo|Placebo
368953|NCT01072136|O1|Outcome|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
368954|NCT01072136|E2|Reported Event|Placebo|Placebo
368955|NCT01072136|E1|Reported Event|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
368956|NCT01072032|B3|Baseline|Total|Total of all reporting groups
368957|NCT01072032|B2|Baseline|High-Reward|"High-Reward Anklebot training Group~Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
368958|NCT01072032|B1|Baseline|Low-Reward|"Low-Reward Anklebot training Group~Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
368959|NCT01072032|P2|Participant Flow|High-Reward|"High-Reward Anklebot training Group~Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
368960|NCT01072032|P1|Participant Flow|Low-Reward|"Low-Reward Anklebot training Group~Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
368961|NCT01072032|O2|Outcome|High-Reward|High-Reward Anklebot training Group: The high-reward group receives cumulative scores and abundant social interaction and are eligible for prizes during each training session and at completion of the study.
368962|NCT01072032|O1|Outcome|Low-Reward|Low-Reward Anklebot training Group: The low reward-feedback group receives the Anklebot training with only immediate feedback on target successes, without cumulative scores and with minimal social interaction with the research team.
368963|NCT01072032|O2|Outcome|High-Reward|High-Reward Anklebot training Group: The high-reward group receives cumulative scores and abundant social interaction and are eligible for prizes during each training session and at completion of the study.
368964|NCT01072032|O1|Outcome|Low-Reward|Low-Reward Anklebot training Group: The low reward-feedback group receives the Anklebot training with only immediate feedback on target successes, without cumulative scores and with minimal social interaction with the research team.
368965|NCT01072032|O2|Outcome|High-Reward|High-Reward Anklebot training Group: The high-reward group receives cumulative scores and abundant social interaction and are eligible for prizes during each training session and at completion of the study.
369087|NCT01071252|O4|Outcome|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
369234|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50 or 70 mg"
368966|NCT01072032|O1|Outcome|Low-Reward|"Low-Reward Anklebot training Group~Anklebot (Ankle Robot): The low reward-feedback group receives the Anklebot training with only immediate feedback on target successes, without cumulative scores and with minimal social interaction with the research team."
368967|NCT01072032|E2|Reported Event|High-Reward|"High-Reward Anklebot training Group~Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
368968|NCT01072032|E1|Reported Event|Low-Reward|"Low-Reward Anklebot training Group~Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
368969|NCT01072006|B5|Baseline|Total|Total of all reporting groups
368970|NCT01072006|B4|Baseline|TBI+PTSD Group|Combined TBI history and PTSD
368971|NCT01072006|B3|Baseline|TBI Group|TBI (no PTSD)
368972|NCT01072006|B2|Baseline|PTSD Group|PTSD (not TBI)
368973|NCT01072006|B1|Baseline|Control Group|Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
368974|NCT01072006|P4|Participant Flow|TBI+PTSD Group|Combined TBI history and PTSD
368975|NCT01072006|P3|Participant Flow|TBI Group|TBI (no PTSD)
368976|NCT01072006|P2|Participant Flow|PTSD Group|PTSD (not TBI)
368977|NCT01072006|P1|Participant Flow|Control Group|Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
368978|NCT01072006|O4|Outcome|TBI+PTSD Group|Combined TBI history and PTSD
368979|NCT01072006|O3|Outcome|TBI Group|TBI (no PTSD)
368980|NCT01072006|O2|Outcome|PTSD Group|PTSD (not TBI)
368981|NCT01072006|O1|Outcome|Control Group|Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
368982|NCT01072006|O4|Outcome|TBI+PTSD Group|Combined TBI history and PTSD
368983|NCT01072006|O3|Outcome|TBI Group|TBI (no PTSD)
368984|NCT01072006|O2|Outcome|PTSD Group|PTSD (not TBI)
368985|NCT01072006|O1|Outcome|Control Group|Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
368986|NCT01072006|O3|Outcome|TBI+PTSD Group|Combined TBI history and PTSD
368987|NCT01072006|O2|Outcome|PTSD Group|PTSD (not TBI)
368988|NCT01072006|O1|Outcome|Control Group|Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
368989|NCT01072006|E4|Reported Event|TBI+PTSD Group|Combined TBI history and PTSD
368990|NCT01072006|E3|Reported Event|TBI Group|TBI (no PTSD)
368991|NCT01072006|E2|Reported Event|PTSD Group|PTSD (not TBI)
368992|NCT01072006|E1|Reported Event|Control Group|Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
368993|NCT01071993|B3|Baseline|Total|Total of all reporting groups
368994|NCT01071993|B2|Baseline|Placebo|placebo: pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
368995|NCT01071993|B1|Baseline|Atorvastatin|atorvastatin: pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
368996|NCT01071993|P2|Participant Flow|Placebo|placebo: pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
368997|NCT01071993|P1|Participant Flow|Atorvastatin|atorvastatin: pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
368998|NCT01071993|O2|Outcome|Placebo|placebo: pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
368999|NCT01071993|O1|Outcome|Atorvastatin|atorvastatin: pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
369000|NCT01071993|E2|Reported Event|Placebo|placebo: pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
369001|NCT01071993|E1|Reported Event|Atorvastatin|atorvastatin: pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
369002|NCT01071915|B1|Baseline|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
369003|NCT01071915|P1|Participant Flow|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
369004|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
369005|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
369006|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
369007|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
369075|NCT01071278|E1|Reported Event|All Evaluable Participants|Participants who were prescribed Tredaptive® for the treatment of dyslipidemia and primary hypercholesterolemia as per the Summary of Product Characteristics (SmPC) by his/her primary physician in a routine clinical setting either within or outside a Disease Management Program (DMP).
369008|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
369009|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
369010|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
369011|NCT01071915|E1|Reported Event|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
369012|NCT01071798|B1|Baseline|Main Analysis Set|Participants who received at least one cycle of rituximab
369013|NCT01071798|P1|Participant Flow|Main Analysis Set|Participants who received at least one cycle of rituximab
369014|NCT01071798|O3|Outcome|Worse|Clinically relevant worsening of HAQ Score ≥0.3
369015|NCT01071798|O2|Outcome|No Change|Other or no clinical relevant change of HAQ-Score
369016|NCT01071798|O1|Outcome|Improved|Clinically relevant improvement of HAQ-Score ≥0.3
369017|NCT01071798|O3|Outcome|Worse|Clinically relevant worsening of HAQ Score ≥0.3
369018|NCT01071798|O2|Outcome|No Change|Other or no clinical relevant change of HAQ-Score
369019|NCT01071798|O1|Outcome|Improved|Clinically relevant improvement of HAQ-Score ≥0.3
369020|NCT01071798|O3|Outcome|Total|During the Trial - All Participants
369021|NCT01071798|O2|Outcome|Cycle 2|During Cycle 2 - Subpopulation With Two Cycles
369022|NCT01071798|O1|Outcome|Cycle 1|During Cycle 1 - Main Analysis Set
369023|NCT01071798|O3|Outcome|Seropositive Participants|Subgroup of seropositive participants
369024|NCT01071798|O2|Outcome|Seronegative Participants|Subgroup of seronegative participants
369025|NCT01071798|O1|Outcome|Main Analysis Set|Participants who received at least one cycle of rituximab
369026|NCT01071798|O3|Outcome|Seropositive Participants|Subgroup of seropositive participants
369027|NCT01071798|O2|Outcome|Seronegative Participants|Subgroup of seronegative participants
369028|NCT01071798|O1|Outcome|Main Analysis Set|Participants who received at least one cycle of rituximab
369029|NCT01071798|E3|Reported Event|Total|During the entire trial
369030|NCT01071798|E2|Reported Event|Cycle 2|During Cycle 2 - Subpopulation With Two Cycles
369031|NCT01071798|E1|Reported Event|Cycle 1|During Cycle 1 - Main Analysis Set
369032|NCT01071538|B1|Baseline|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
369033|NCT01071538|P1|Participant Flow|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
369034|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
369035|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
369036|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
369037|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
369038|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
369039|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
369040|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
369041|NCT01071538|E1|Reported Event|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
369042|NCT01071512|B1|Baseline|Tysabri|Natalizumab 300 mg IV every 4 weeks
369043|NCT01071512|P1|Participant Flow|Tysabri|Natalizumab 300 mg IV every 4 weeks
369044|NCT01071512|O1|Outcome|Tysabri|Natalizumab 300 mg IV every 4 weeks
369045|NCT01071512|O1|Outcome|Tysabri|Natalizumab 300 mg IV every 4 weeks
369046|NCT01071512|O1|Outcome|Tysabri|Natalizumab 300 mg IV every 4 weeks
369047|NCT01071512|O1|Outcome|Tysabri|Natalizumab 300 mg IV every 4 weeks
369048|NCT01071512|O1|Outcome|Tysabri|Natalizumab 300 mg IV every 4 weeks
369049|NCT01071512|E1|Reported Event|Tysabri|Natalizumab 300 mg IV every 4 weeks
369050|NCT01071395|B3|Baseline|Total|Total of all reporting groups
369051|NCT01071395|B2|Baseline|Placebo|Placebo: Sugar pill given 3 times daily
369052|NCT01071395|B1|Baseline|Amantadine|Amantadine: Amantadine hydrochloride 300mg daily in three divided doses
369053|NCT01071395|P2|Participant Flow|Placebo|Placebo: Sugar pill given 3 times daily
369054|NCT01071395|P1|Participant Flow|Amantadine|Amantadine: Amantadine hydrochloride 300mg daily in three divided doses
369055|NCT01071395|O2|Outcome|Placebo|Placebo: Sugar pill given daily in three divided doses
369056|NCT01071395|O1|Outcome|Amantadine|Amantadine: Amantadine hydrochloride 300mg daily in three divided doses
369057|NCT01071395|E2|Reported Event|Placebo|Placebo: Sugar pill given 3 times daily
369058|NCT01071395|E1|Reported Event|Amantadine|Amantadine: Amantadine hydrochloride 300mg daily in three divided doses
369059|NCT01071356|B3|Baseline|Total|Total of all reporting groups
369060|NCT01071356|B2|Baseline|1 Session of Motivational Interviewing + 8 Sessions Nutrition|"Respondents received one 1.5-hour session of Motivational Interviewing therapy at the outset of entering outpatient drug treatment.~Single session of Motivational Interviewing"
369061|NCT01071356|B1|Baseline|9 Sessions of Motivational Interviewing|"Respondents received 9 1-hour sessions of Motivational Interviewing therapy concurrent with outpatient drug treatment.~Intensive Motivational Interviewing: Weekly individual therapy sessions over 9 weeks (Intensive MI condition) consisting of supportive and directive interventions. The control condition consists on a single session of MI and nutritional education."
369062|NCT01071356|P2|Participant Flow|1 Session of Motivational Interviewing + 8 Sessions Nutrition|"Respondents received one 1.5-hour session of Motivational Interviewing therapy at the outset of entering outpatient drug treatment.~Single session of Motivational Interviewing"
369063|NCT01071356|P1|Participant Flow|9 Sessions of Motivational Interviewing|"Respondents received 9 1-hour sessions of Motivational Interviewing therapy concurrent with outpatient drug treatment.~Intensive Motivational Interviewing: Weekly individual therapy sessions over 9 weeks (Intensive MI condition) consisting of supportive and directive interventions. The control condition consists on a single session of MI and nutritional education."
369064|NCT01071356|O2|Outcome|1 Session of Motivational Interviewing + 8 Sessions Nutrition|"Respondents received one 1.5-hour session of Motivational Interviewing therapy at the outset of entering outpatient drug treatment.~Single session of Motivational Interviewing"
369065|NCT01071356|O1|Outcome|9 Sessions of Motivational Interviewing|"Respondents received 9 1-hour sessions of Motivational Interviewing therapy concurrent with outpatient drug treatment.~Intensive Motivational Interviewing: Weekly individual therapy sessions over 9 weeks (Intensive MI condition) consisting of supportive and directive interventions. The control condition consists on a single session of MI and nutritional education."
369066|NCT01071356|O2|Outcome|1 Session of Motivational Interviewing + 8 Sessions Nutrition|"Respondents received one 1.5-hour session of Motivational Interviewing therapy at the outset of entering outpatient drug treatment.~Single session of Motivational Interviewing"
369067|NCT01071356|O1|Outcome|9 Sessions of Motivational Interviewing|"Respondents received 9 1-hour sessions of Motivational Interviewing therapy concurrent with outpatient drug treatment.~Intensive Motivational Interviewing: Weekly individual therapy sessions over 9 weeks (Intensive MI condition) consisting of supportive and directive interventions. The control condition consists on a single session of MI and nutritional education."
369068|NCT01071356|E2|Reported Event|1 Session of Motivational Interviewing + 8 Sessions Nutrition|"Respondents received one 1.5-hour session of Motivational Interviewing therapy at the outset of entering outpatient drug treatment.~Single session of Motivational Interviewing"
369069|NCT01071356|E1|Reported Event|9 Sessions of Motivational Interviewing|"Respondents received 9 1-hour sessions of Motivational Interviewing therapy concurrent with outpatient drug treatment.~Intensive Motivational Interviewing: Weekly individual therapy sessions over 9 weeks (Intensive MI condition) consisting of supportive and directive interventions. The control condition consists on a single session of MI and nutritional education."
369070|NCT01071278|B1|Baseline|Intent-to-Treat Population|Baseline characteristics were reported for the 2359 participants in the Intent-to-Treat (ITT) Population, which included all participants from the Evaluable Population who began therapy at or after Visit 1. The ITT Population excluded 31 of the 2390 evaluable participants who began treatment prior to Visit 1.
369071|NCT01071278|P1|Participant Flow|All Evaluable Participants|Participants who were prescribed Tredaptive® for the treatment of dyslipidemia and primary hypercholesterolemia as per the Summary of Product Characteristics (SmPC) by his/her primary physician in a routine clinical setting either within or outside a Disease Management Program (DMP).
369072|NCT01071278|O1|Outcome|All Evaluable Participants|Participants who were prescribed Tredaptive® for the treatment of dyslipidemia and primary hypercholesterolemia as per the Summary of Product Characteristics (SmPC) by his/her primary physician in a routine clinical setting either within or outside a Disease Management Program (DMP).
369073|NCT01071278|O2|Outcome|Patients Treated Outside a Disease Management Program|Participant prescribed Tredaptive® for dyslipidemia and did not participate in a disease management program for treatment of diabetes mellitus, coronary heart disease or both.
369074|NCT01071278|O1|Outcome|Patients Treated Within a Disease Management Program|Participant prescribed Tredaptive® for dyslipidemia and also participated in a disease management program for treatment of diabetes mellitus, coronary heart disease or both.
369088|NCT01071252|O3|Outcome|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
369089|NCT01071252|O2|Outcome|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
369090|NCT01071252|O1|Outcome|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
369091|NCT01071252|O5|Outcome|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
369092|NCT01071252|O4|Outcome|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
369093|NCT01071252|O3|Outcome|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
369094|NCT01071252|O2|Outcome|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
369095|NCT01071252|O1|Outcome|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
369096|NCT01071252|O5|Outcome|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
369097|NCT01071252|O4|Outcome|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
369098|NCT01071252|O3|Outcome|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
369099|NCT01071252|O2|Outcome|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
369100|NCT01071252|O1|Outcome|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
369101|NCT01071252|O5|Outcome|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
369102|NCT01071252|O4|Outcome|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
369103|NCT01071252|O3|Outcome|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
369104|NCT01071252|O2|Outcome|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
369105|NCT01071252|O1|Outcome|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
369106|NCT01071252|E5|Reported Event|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
369107|NCT01071252|E4|Reported Event|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
369108|NCT01071252|E3|Reported Event|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
369109|NCT01071252|E2|Reported Event|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
369110|NCT01071252|E1|Reported Event|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
369111|NCT01071200|B3|Baseline|Total|Total of all reporting groups
369112|NCT01071200|B2|Baseline|Follicle-stimulating Hormone (FSH)|FSH injection s.c. administered according to investigator’s discretion till r-hCG administration day.
369113|NCT01071200|B1|Baseline|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
369114|NCT01071200|P2|Participant Flow|Follicle-stimulating Hormone (FSH)|FSH injection s.c. administered according to investigator’s discretion till r-hCG administration day.
369115|NCT01071200|P1|Participant Flow|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
369116|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
369117|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
369118|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
369119|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
369120|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
369121|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
369122|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
369123|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
369124|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
369125|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
369227|NCT01071044|O1|Outcome|Treatment Group|Lisdexamfetamine Dimesylate 30, 50 or 70 mg
369126|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
369127|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
369128|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
369129|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
369130|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
369131|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
369132|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
369133|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
369134|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
369135|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
369136|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
369137|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
369138|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
369139|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
369140|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
369141|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
369142|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
369143|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
369144|NCT01071200|E2|Reported Event|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
369145|NCT01071200|E1|Reported Event|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
369146|NCT01071096|B1|Baseline|Enrolled Participants|Enrolled Participants includes subjects in both Group A (treated with BOTOX and Visit 1 and Placebo at Visit 5) and Group B (treated with Placebo at Visit 1 and BOTOX at Visit 5).
369147|NCT01071096|P2|Participant Flow|Group B|Subjects were injected with Saline at Visit 1 (Day 1) and followed for 3 months through monthly office visits (Visits 2, 3, and 4 at Days 31, 61 and 91). Subjects went through a 1 month (30 day) washout period between Visit 4 (Day 91) and Visit 5 (Day 121). Subjects were injected with OnabotulinumtoxinA at Visit 5 (Day 121) and followed for 3 months through monthly office visits (Visits 5, 6, and 7 at Days 151, 181, and 211).
369148|NCT01071096|P1|Participant Flow|Group A|Subjects were injected with OnabotulinumtoxinA at Visit 1 (Day 1) and followed for 3 months through monthly office visits (Visits 2, 3, and 4 at Days 31, 61 and 91). Subjects went through a 1 month (30 day) washout period between Visit 4 (Day 91) and Visit 5 (Day 121). Subjects were injected with Saline at Visit 5 (Day 121) and followed for 3 months through monthly office visits (Visits 5, 6, and 7 at Days 151, 181, and 211).
369149|NCT01071096|O6|Outcome|Month 1 vs. Month 3 Non-Responders|Fold change between first and third treatment months with OnabotulinumtoxinA in subjects with <30% reduction in number of headache days per month from baseline.
369150|NCT01071096|O5|Outcome|Month 1 vs. Month 3 Responders|Fold change between first and third treatment months with OnabotulinumtoxinA in subjects with >30% reduction in number of headache days per month from baseline.
369151|NCT01071096|O4|Outcome|Month 3 vs. Saline Non-Responders|Fold change between third treatment months with OnabotulinumtoxinA and Saline in subjects with <30% reduction in number of headache days per month from baseline.
369152|NCT01071096|O3|Outcome|Month 3 vs. Saline Responders|Fold change between third treatment months with OnabotulinumtoxinA and Saline in subjects with >30% reduction in number of headache days per month from baseline.
369153|NCT01071096|O2|Outcome|Month 1 vs. Saline Non-Responders|Fold change between first treatment months with OnabotulinumtoxinA and Saline in subjects with <30% reduction in number of headache days per month from baseline.
369154|NCT01071096|O1|Outcome|Month 1 vs. Saline Responders|Fold change between first treatment months with OnabotulinumtoxinA and Saline in subjects with >30% reduction in number of headache days per month from baseline.
369155|NCT01071096|O3|Outcome|Saline|This group is a combination of information gathered from both groups while treating with Saline: Group A (Months 5-7) and Group B (Months 1-3).
369156|NCT01071096|O2|Outcome|OnabotulinumtoxinA Non-Responders|This group is a combination of information gathered from both groups while treating with OnabotulinumtoxinA: Group A (Months 1-3) and Group B (Months 5-7). Includes subjects with <30% reduction in number of headache days per month when compared to Baseline
369157|NCT01071096|O1|Outcome|OnabotulinumtoxinA Responders|This group is a combination of information gathered from both groups while treating with OnabotulinumtoxinA: Group A (Months 1-3) and Group B (Months 5-7). Includes subjects with >30% reduction in number of headache days per month when compared to Baseline
369158|NCT01071096|O2|Outcome|Saline|This group is a combination of information gathered from both groups while treating with Saline: Group A (Months 5-7) and Group B (Months 1-3).
369159|NCT01071096|O1|Outcome|OnabotulinumtoxinA|This group is a combination of information gathered from both groups while treating with OnabotulinumtoxinA: Group A (Months 1-3) and Group B (Months 5-7).
369160|NCT01071096|O2|Outcome|Group B|Saline at Visit 1 (headache days in Months 1, 2 and 3) and OnabotulinumtoxinA at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
369161|NCT01071096|O1|Outcome|Group A|OnabotulinumtoxinA at Visit 1 (headache days in Months 1, 2 and 3) and Saline at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
369162|NCT01071096|O2|Outcome|Group B|Saline at Visit 1 (headache days in Months 1, 2 and 3) and OnabotulinumtoxinA at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
369163|NCT01071096|O1|Outcome|Group A|OnabotulinumtoxinA at Visit 1 (headache days in Months 1, 2 and 3) and Saline at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
369164|NCT01071096|E2|Reported Event|OnabotulinumtoxinA|Subjects injected with onabotulinumtoxinA in Group A at Visit 1 (Day 1) and Group B at Visit 5 (Day 151)
369165|NCT01071096|E1|Reported Event|Saline|Subjects injected with Saline in Group A at Visit 5 (Day 151) and Group B at Visit 1 (Day 1)
369166|NCT01071083|B6|Baseline|Total|Total of all reporting groups
369167|NCT01071083|B5|Baseline|Methylprednisolone|1000 mg intravenous every 4 weeks
369168|NCT01071083|B4|Baseline|Glatiramer Acetate|20 mg subcutaneous once daily
369169|NCT01071083|B3|Baseline|Interferon β-1a|30 ug intramuscular once per week
369170|NCT01071083|B2|Baseline|Intravenous Placebo|placebo matching natalizumab, intravenous every 4 weeks
369171|NCT01071083|B1|Baseline|Natalizumab|300 mg intravenous every 4 weeks
369172|NCT01071083|P5|Participant Flow|Methylprednisolone|1000 mg intravenous every 4 weeks
369173|NCT01071083|P4|Participant Flow|Glatiramer Acetate|20 mg subcutaneous once daily
369174|NCT01071083|P3|Participant Flow|Interferon β-1a|30 ug intramuscular once per week
369175|NCT01071083|P2|Participant Flow|Natalizumab|300 mg intravenous every 4 weeks
369176|NCT01071083|P1|Participant Flow|Intravenous Placebo|placebo matching natalizumab, intravenous every 4 weeks
369177|NCT01071083|O5|Outcome|Methylprednisolone|1000 mg intravenous every 4 weeks
369178|NCT01071083|O4|Outcome|Glatiramer Acetate|20 mg subcutaneous once daily
369179|NCT01071083|O3|Outcome|Interferon β-1a|30 ug intramuscular once per week
369180|NCT01071083|O2|Outcome|Intravenous Placebo|placebo matching natalizumab, intravenous every 4 weeks
369181|NCT01071083|O1|Outcome|Natalizumab|300 mg intravenous every 4 weeks
369182|NCT01071083|O5|Outcome|Methylprednisolone|1000 mg intravenous every 4 weeks
369183|NCT01071083|O4|Outcome|Glatiramer Acetate|20 mg subcutaneous once daily
369184|NCT01071083|O3|Outcome|Interferon β-1a|30 ug intramuscular once per week
369185|NCT01071083|O2|Outcome|Intravenous Placebo|placebo matching natalizumab, intravenous every 4 weeks
369186|NCT01071083|O1|Outcome|Natalizumab|300 mg intravenous every 4 weeks
369187|NCT01071083|E5|Reported Event|Methylprednisolone|1000 mg intravenous every 4 weeks
369188|NCT01071083|E4|Reported Event|Glatiramer Acetate|20 mg subcutaneous once daily
369189|NCT01071083|E3|Reported Event|Interferon β-1a|30 ug intramuscular once per week
369190|NCT01071083|E2|Reported Event|Natalizumab|300 mg intravenous every 4 weeks
369191|NCT01071083|E1|Reported Event|Intravenous Placebo|placebo matching natalizumab, intravenous every 4 weeks
369192|NCT01071070|B3|Baseline|Total|Total of all reporting groups
369193|NCT01071070|B2|Baseline|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
369194|NCT01071070|B1|Baseline|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
369195|NCT01071070|P2|Participant Flow|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
369196|NCT01071070|P1|Participant Flow|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
369197|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
369198|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
369199|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
369200|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
369201|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
369202|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
369203|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
369204|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
369205|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
369206|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
369207|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
369208|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
369209|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
369210|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
369211|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
369212|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
369213|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
369214|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
369215|NCT01071070|E2|Reported Event|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
369216|NCT01071070|E1|Reported Event|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
369217|NCT01071044|B3|Baseline|Total|Total of all reporting groups
369218|NCT01071044|B2|Baseline|Sugar Pill|Placebo Comparator: Sugar pill : Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.
369219|NCT01071044|B1|Baseline|Lisdexamfetamine Dimesylate|"Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.~Lisdexamfetamine Dimesylate : Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo)."
369220|NCT01071044|P2|Participant Flow|Sugar Pill|Placebo Comparator: Sugar pill : Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.
369221|NCT01071044|P1|Participant Flow|Lisdexamfetamine Dimesylate|"Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.~Lisdexamfetamine Dimesylate : Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo)."
369222|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50 or 70 mg"
369223|NCT01071044|O1|Outcome|Treatment Group|Lisdexamfetamine Dimesylate 30, 50 or 70 mg
369224|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50 or 70 mg"
369225|NCT01071044|O1|Outcome|Treatment Group|Lisdexamfetamine Dimesylate, 30, 50 or 70 mg
369226|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50 or 70 mg"
369235|NCT01071044|O1|Outcome|Treatment Group|Lisdexamfetamine Dimesylate 30, 50 or 70 mg
369236|NCT01071044|E2|Reported Event|Control Group|"Placebo 30, 50 or 70 mg"
369237|NCT01071044|E1|Reported Event|Treatment Group|Lisdexamfetamine Dimesylate 30, 50, or 70 mg
369238|NCT01070979|B4|Baseline|Total|Total of all reporting groups
369239|NCT01070979|B3|Baseline|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
369240|NCT01070979|B2|Baseline|Estradiol|1 tablet daily containing 1 mg estradiol
369241|NCT01070979|B1|Baseline|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
369242|NCT01070979|P3|Participant Flow|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
369243|NCT01070979|P2|Participant Flow|Estradiol|1 tablet daily containing 1 mg estradiol
369244|NCT01070979|P1|Participant Flow|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
369245|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
369246|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
369247|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
369248|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
369249|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
369250|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
369251|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
369252|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
369253|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
369254|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
369255|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
369256|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
369257|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
369258|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
369259|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
369260|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
369261|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
369262|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
369263|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
369264|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
369265|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
369266|NCT01070979|E3|Reported Event|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
369267|NCT01070979|E2|Reported Event|Estradiol|1 tablet daily containing 1 mg estradiol
369268|NCT01070979|E1|Reported Event|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
369269|NCT01070966|B1|Baseline|VYTORIN® 10/10 mg/Day to 10/80 mg/Day|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® ranging from 10/10 mg/day through 10/80 mg/day for Years 1 to 6.
369270|NCT01070966|P1|Participant Flow|VYTORIN® 10/10 mg/Day to 10/80 mg/Day|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)treated with VYTORIN® dosages ranging from 10/10(ezetimibe 10 mg/simvastatin 10 mg tablets)a day to 10/80(ezetimibe 10 mg/simvastatin 80 mg tablets)a day.
369271|NCT01070966|O3|Outcome|Participants Percent Change|
369272|NCT01070966|O2|Outcome|Participants Treatment Lipid Parameters|Participants treatment lipid parameters for Total Cholesterol, HDL cholesterol, LDL cholesterol and Triglyceride.
369273|NCT01070966|O1|Outcome|Participants Baseline Lipid Parameters|Participants baseline lipid parameters for Total Cholesterol, HDL cholesterol, LDL cholesterol and Triglyceride.
369274|NCT01070966|O1|Outcome|Participants Treated With VYTORIN|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Years 1 to 6.
369275|NCT01070966|E5|Reported Event|VYTORIN YEAR 6|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 6
369276|NCT01070966|E4|Reported Event|VYTORIN YEAR 5|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 5
369277|NCT01070966|E3|Reported Event|VYTORIN YEAR 4|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 4
369278|NCT01070966|E2|Reported Event|VYTORIN YEAR 2|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 2
369279|NCT01070966|E1|Reported Event|VYTORIN YEAR 1|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 1
369280|NCT01070953|B1|Baseline|EZETROL® 10 mg|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
369281|NCT01070953|P1|Participant Flow|EZETROL® 10 mg|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
369282|NCT01070953|O1|Outcome|EZETROL® 10 mg|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
369283|NCT01070953|O1|Outcome|All Participants|
369284|NCT01070953|O1|Outcome|EZETROL® 10 mg|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
369285|NCT01070953|E6|Reported Event|EZETROL Year 6|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 6.
369327|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369286|NCT01070953|E5|Reported Event|EZETROL Year 5|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 5.
369287|NCT01070953|E4|Reported Event|EZETROL Year 4|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 4.
369288|NCT01070953|E3|Reported Event|EZETROL Year 3|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 3.
369289|NCT01070953|E2|Reported Event|EZETROL Year 2|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 2.
369290|NCT01070953|E1|Reported Event|EZETROL Year 1|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 1.
369291|NCT01070888|B3|Baseline|Total|Total of all reporting groups
369292|NCT01070888|B2|Baseline|Budesonide/Formoterol First|"This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.~Budesonide/Formoterol : Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks, followed by a washout, then Budesonide 180mcg, 2 puffs twice daily for 2 weeks,"
369293|NCT01070888|B1|Baseline|Budesonide First|"This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.~Budesonide first: Budesonide 180mcg, 2 puffs twice daily for 2 weeks, followed by a washout, then Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks"
369294|NCT01070888|P2|Participant Flow|Budesonide/Formoterol First|"This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Subjects will subsequently take blinded budesonide and dummy inhale, 2 inhalations of each, twice daily.~Budesonide/Formoterol : Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks"
369295|NCT01070888|P1|Participant Flow|Budesonide First|"This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Subjects will subsequently take blinded budesonide/formoterol and dummy inhale, 2 inhalations of each, twice daily.~Budesonide : Budesonide 180mcg, 2 puffs twice daily for 2 weeks"
369296|NCT01070888|O2|Outcome|Budesonide/Formoterol First|"This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily, then in the subsequent period take budesonide and dummy inhaler 2 puffs twice daily.~Budesonide/Formoterol : Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks"
369297|NCT01070888|O1|Outcome|Budesonide First|"This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Then in the subsequent study period take budesonide/formoterol plus dummy inhaler 2 inhalations of each inhaler, twice daily~Budesonide : Budesonide 180mcg, 2 puffs twice daily for 2 weeks"
369298|NCT01070888|E2|Reported Event|Budesonide|"This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.~Budesonide: Budesonide 180mcg, 2 puffs twice daily for 2 weeks, followed by a washout, then Budesonide/formoterol 180mcg, 2 puffs twice daily for 2 weeks"
369299|NCT01070888|E1|Reported Event|Budesonide/Formoterol|"This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.~Budesonide/Formoterol: Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks, followed by a washout, then Budesonide 180mcg, 2 puffs twice daily for 2 weeks"
369300|NCT01070810|B3|Baseline|Total|Total of all reporting groups
369301|NCT01070810|B2|Baseline|Thiamine|200mg Thiamine in 50ml D5W Thiamine: Thiamine 200mg in 50ml Dextrose 5%
369302|NCT01070810|B1|Baseline|Placebo|50 ml D5W D5W: Dextrose 5%
369303|NCT01070810|P2|Participant Flow|Thiamine|"200mg Thiamine in 50ml D5W~Thiamine: Thiamine 200mg in 50ml Dextrose 5%"
369304|NCT01070810|P1|Participant Flow|Placebo|"50 ml D5W~D5W: Dextrose 5%"
369305|NCT01070810|O2|Outcome|Thiamine Deficient, Received Placebo|Thiamine deficient (≤ 7 nmol/L) received 50ml D5W
369306|NCT01070810|O1|Outcome|Thiamine Deficient Received Thiamine|Thiamine deficient (≤ 7 nmol/L) received 200mg Thiamine in 50ml D5W
369307|NCT01070810|O2|Outcome|Thiamine Deficient, Received Placebo|Thiamine deficient (≤ 7 nmol/L) received 50ml D5W
369308|NCT01070810|O1|Outcome|Thiamine Deficient Received Thiamine|Thiamine deficient (≤ 7 nmol/L) received 200mg Thiamine in 50ml D5W
369309|NCT01070810|O2|Outcome|Thiamine|"200mg Thiamine in 50ml D5W~Thiamine: Thiamine 200mg in 50ml Dextrose 5%"
369310|NCT01070810|O1|Outcome|Placebo|"50 ml D5W~D5W: Dextrose 5%"
369311|NCT01070810|O2|Outcome|Thiamine|"200mg Thiamine in 50ml D5W~Thiamine: Thiamine 200mg in 50ml Dextrose 5%"
369312|NCT01070810|O1|Outcome|Placebo|"50 ml D5W~D5W: Dextrose 5%"
369313|NCT01070810|O2|Outcome|Thiamine|"200mg Thiamine in 50ml D5W~Thiamine: Thiamine 200mg in 50ml Dextrose 5%"
369314|NCT01070810|O1|Outcome|Placebo|"50 ml D5W~D5W: Dextrose 5%"
369315|NCT01070810|E2|Reported Event|Thiamine|200mg Thiamine in 50ml D5W Thiamine: Thiamine 200mg in 50ml Dextrose 5%
369316|NCT01070810|E1|Reported Event|Placebo|50 ml D5W D5W: Dextrose 5%
369317|NCT01070784|B3|Baseline|Total|Total of all reporting groups
369318|NCT01070784|B2|Baseline|COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369319|NCT01070784|B1|Baseline|Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369320|NCT01070784|P2|Participant Flow|COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369321|NCT01070784|P1|Participant Flow|Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369322|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369323|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369324|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369325|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369326|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
371562|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
369328|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369329|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369330|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369331|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369332|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369333|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369334|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369335|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369336|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369337|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369338|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369339|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369340|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369341|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369342|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369343|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369344|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369345|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369346|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369347|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369348|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369349|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369350|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369351|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369352|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369353|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369354|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369355|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369356|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369357|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369358|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369359|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369360|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369361|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369362|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369363|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369364|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369365|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369366|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369367|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369368|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369369|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369370|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369371|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369372|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369373|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369374|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369375|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369376|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369377|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369378|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369379|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369380|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369381|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369382|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369383|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369384|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369385|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369386|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369387|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369388|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369389|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369390|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369391|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369392|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369393|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369394|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369395|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369396|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369397|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369398|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369399|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369400|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369401|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369402|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369403|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369404|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369405|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369406|NCT01070784|E2|Reported Event|COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
369407|NCT01070784|E1|Reported Event|Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
369408|NCT01070771|B1|Baseline|Radi Pressure Wire|
369409|NCT01070771|P1|Participant Flow|Radi Pressure Wire|Assessment of physiological significance of coronary artery narrowings by measurement of blood flow limitation across lesion.
369410|NCT01070771|O1|Outcome|RADI Pressure Wire|
369411|NCT01070771|O1|Outcome|Radi Pressure Wire|
369412|NCT01070771|E1|Reported Event|RADI Pressure Wire|
369413|NCT01070693|B3|Baseline|Total|Total of all reporting groups
369414|NCT01070693|B2|Baseline|Lichtenstein|Inguinal hernia repair with the Lichtenstein technique
369415|NCT01070693|B1|Baseline|Prolene Hernia System Device|Inguinal hernia repair either with a bilayer mesh (PHS)
369416|NCT01070693|P2|Participant Flow|Lichtenstein|Inguinal hernia repair with the Lichtenstein technique
369417|NCT01070693|P1|Participant Flow|Prolene Hernia System Device|Inguinal hernia repair either with a bilayer mesh (PHS)
369418|NCT01070693|O2|Outcome|Lichtenstein|"Inguinal hernia repair with the Lichtenstein technique~Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique~Lichtenstein technique: Lichtenstein technique"
369419|NCT01070693|O1|Outcome|Prolene Hernia System Device|"Inguinal hernia repair either with a bilayer mesh (PHS)~Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique~Prolene Hernia System: Prolene Hernia System"
369420|NCT01070693|E2|Reported Event|Lichtenstein|"Inguinal hernia repair with the Lichtenstein technique~Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique~Lichtenstein technique: Lichtenstein technique"
369421|NCT01070693|E1|Reported Event|Prolene Hernia System Device|"Inguinal hernia repair either with a bilayer mesh (PHS)~Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique~Prolene Hernia System: Prolene Hernia System"
369422|NCT01070550|B7|Baseline|Total|Total of all reporting groups
369423|NCT01070550|B6|Baseline|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369424|NCT01070550|B5|Baseline|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369425|NCT01070550|B4|Baseline|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369426|NCT01070550|B3|Baseline|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
372266|NCT01063595|O2|Outcome|Octaplas SD|Participants received 1200 mL of Octaplas SD intravenously once.
369427|NCT01070550|B2|Baseline|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369428|NCT01070550|B1|Baseline|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369429|NCT01070550|P6|Participant Flow|Genotype Unknown|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369430|NCT01070550|P5|Participant Flow|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received peginterferon alfa-2a plus ribavirin according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369431|NCT01070550|P4|Participant Flow|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received peginterferon alfa-2a plus ribavirin according to the standard of care and in line with SPCs/local labeling were observed for up to 72 weeks.
369432|NCT01070550|P3|Participant Flow|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received peginterferon alfa-2a plus ribavirin according to the standard of care and in line with SPCs/local labeling were observed for up to 72 weeks.
369433|NCT01070550|P2|Participant Flow|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labelling were observed for up to 72 weeks.
369434|NCT01070550|P1|Participant Flow|Genotype 1|Eligible participants infected with hepatitis C virus (HCV) of Genotype 1 who received PEGASYS® (Pegylated Interferon [PEG-IFN]) alfa-2a plus ribavirin according to the standard of care and in line with summary of product characteristics (SPCs)/local labelling were observed for up to 72 weeks.
369435|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369436|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369437|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369438|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369439|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369440|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369441|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369442|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369443|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369444|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369445|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369446|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369447|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369448|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369449|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369450|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369451|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369452|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369453|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369454|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369455|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369456|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369457|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369458|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369459|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369460|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369461|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369462|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369463|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369464|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369465|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369466|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369467|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369468|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369469|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369470|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369471|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369472|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369473|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369474|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369475|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369476|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369477|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369478|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369479|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369480|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369481|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369482|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369935|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
369483|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369484|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369485|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369486|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369487|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369488|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369489|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369490|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369491|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369492|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369493|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369494|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369495|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369496|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369497|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369498|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369499|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369500|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369501|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369502|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369503|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369504|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369505|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369506|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369507|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369508|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369509|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369510|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
370232|NCT01068769|B1|Baseline|Regorafenib|Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle
369511|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369512|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369513|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369514|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369515|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369516|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369517|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369518|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369519|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369520|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369521|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369522|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369523|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369524|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369525|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369526|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369527|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369528|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369529|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369530|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369531|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369532|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369533|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369534|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369535|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369536|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369537|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369538|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
370233|NCT01068769|P1|Participant Flow|Regorafenib|Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle
369539|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369540|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369541|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369542|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369543|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369544|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369545|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369546|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369547|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369548|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369549|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369550|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369551|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369552|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369553|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369554|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369555|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369556|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369557|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369558|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369559|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369560|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369561|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369562|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369563|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369564|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369565|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369566|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received Peginterferon (PEG-IFN) alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
370234|NCT01068769|O1|Outcome|Regorafenib|Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle
369567|NCT01070550|E6|Reported Event|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369568|NCT01070550|E5|Reported Event|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369569|NCT01070550|E4|Reported Event|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369570|NCT01070550|E3|Reported Event|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369571|NCT01070550|E2|Reported Event|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369572|NCT01070550|E1|Reported Event|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
369573|NCT01070394|B1|Baseline|LDX Treatment|Prospective participants will be evaluated for ADHD and study inclusion/exclusion criteria. Eligible participants will begin open-label lisdexamfetamine dimesylate for 12 weeks. Those who were able to complete all 12 weeks of the treatment were evaluated for data purposes.
369574|NCT01070394|P1|Participant Flow|Overall Study: Lisdexamfetamine Treatment|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
369575|NCT01070394|O1|Outcome|Overall Study|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
369576|NCT01070394|O1|Outcome|Overall Study|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
369577|NCT01070394|O1|Outcome|Overall Study|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
369578|NCT01070394|O1|Outcome|Overall Study|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
369579|NCT01070394|O1|Outcome|Overall Study|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
369607|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
369608|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
369580|NCT01070394|O1|Outcome|Treatment Arm|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
369581|NCT01070394|O1|Outcome|Overall Study|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
369582|NCT01070394|O1|Outcome|Overall Study|"Eligible participants received 12 weeks of open-label treatment. Those on treatment prior to baseline underwent a 7-day (for amphetamine or methylphenidate) or 28-day (for atomoxetine or other medications) washout period prior to initiating LDX treatment. The starting dose was 30mg/day, which could be titrated up by 20mg/day during visits 2-6 (for a maximum dose of 70mg/day). At discretion of investigator, the dose could be down-titrated by 20mg/day during visits 4-6. Once the dose was optimized (after visit 6), the dose was maintained for 8 weeks.~LDX Treatment: 30 mg, 50mg, or 70 mg. Oral capsule, once a day, for 12 weeks."
369583|NCT01070394|E1|Reported Event|LDX Treatment|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
369584|NCT01070381|B1|Baseline|Overall Study|This reporting group includes all enrolled and dispensed subjects
369585|NCT01070381|P2|Participant Flow|Ocufilcon D / Nelfilcon A|Ocufilcon D contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
369586|NCT01070381|P1|Participant Flow|Nelfilcon A / Ocufilcon D|Nelfilcon A contact lenses worn first, with ocufilcon D contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
369587|NCT01070381|O2|Outcome|Ocufilcon D|Commercially marketed, toric, soft contact lens for daily disposable wear
369588|NCT01070381|O1|Outcome|Nelfilcon A|Commercially marketed, toric, soft contact lens for daily disposable wear
369589|NCT01070381|E2|Reported Event|Ocufilcon D|Commercially marketed, toric, soft contact lens for daily disposable wear
369590|NCT01070381|E1|Reported Event|Nelfilcon A|Commercially marketed, toric, soft contact lens for daily disposable wear
369591|NCT01070329|B3|Baseline|Total|Total of all reporting groups
369592|NCT01070329|B2|Baseline|Placebo|Participants received placebo QD, po for 8 weeks.
369593|NCT01070329|B1|Baseline|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
369594|NCT01070329|P2|Participant Flow|Placebo|Participants received placebo QD, po for 8 weeks.
369595|NCT01070329|P1|Participant Flow|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
369596|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
369597|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
369598|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
369599|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
369600|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
369601|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
369602|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
369603|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
369604|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
369605|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
369606|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
369715|NCT01070043|O2|Outcome|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
369609|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
369610|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
369611|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
369612|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
369613|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
369614|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
369615|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
369616|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
369617|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
369618|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
369619|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
369620|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
369621|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
369622|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
369623|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
369624|NCT01070329|E2|Reported Event|Placebo|Participants received placebo QD, po for 8 weeks.
369625|NCT01070329|E1|Reported Event|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
369626|NCT01070316|B1|Baseline|Everolimus|"Main Study Phase:~Subjects will be administered study drug if they meet study criteria after 4 weeks of baseline phase. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, taken daily.~Everolimus: Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day~Following the 4 week titration, subjects will continue in an 8 week maintenance period.~If subjects qualify for the Extension Phase of the study, they will continue on study drug and be followed through 48 months."
369627|NCT01070316|P1|Participant Flow|Everolimus|"Subjects will be administered study drug if they meet study criteria after 4 weeks of baseline phase. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily.~Everolimus: Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If Blood trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If Blood trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If Blood trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If Blood trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day"
369628|NCT01070316|O1|Outcome|Everolimus|"Main Study Phase:~Subjects will be administered study drug if they meet study criteria after 4 weeks of baseline phase. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, taken daily.~Everolimus: Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day~Following the 4 week titration, subjects will continue in an 8 week maintenance period.~If subjects qualify for the Extension Phase of the study, they will continue on study drug and be followed through 48 months."
369629|NCT01070316|O1|Outcome|Everolimus|"Main Study Phase:~Subjects will be administered study drug if they meet study criteria after 4 weeks of baseline phase. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, taken daily.~Everolimus: Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day~Following the 4 week titration, subjects will continue in an 8 week maintenance period.~If subjects qualify for the Extension Phase of the study, they will continue on study drug and be followed through 48 months."
369651|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
369936|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
369630|NCT01070316|E1|Reported Event|Everolimus|"Subjects will be administered study drug if they meet study criteria after 4 weeks of baseline phase. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily.~Everolimus: Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If Blood trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If Blood trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If Blood trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If Blood trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day"
369631|NCT01070303|B3|Baseline|Total|Total of all reporting groups
369632|NCT01070303|B2|Baseline|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
369633|NCT01070303|B1|Baseline|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
369634|NCT01070303|P1|Participant Flow|All Participants in Open-Label Extension of Study M02-433|Participants who were still receiving study drug and were evaluated at Week 56 of NCT00055497 could continue into the OLE. In the OLE, participants who received double-blind study drug (adalimumab 40 mg) during the DB portion were started on adalimumab 40 mg every other week (eow). Participants who received OL adalimumab 40 mg during the DB portion continued the dose they were receiving. Any participant who was receiving 40 mg adalimumab eow during the OLE and who experienced a disease flare (recurrence of active disease) could change to 40 mg adalimumab weekly. 176 participants were documented as completing Year 1 of the study; however, efficacy data were recorded for 177 participants at Week 56, and those participants are included in the OLE. Safety data are summarized for all participants (N = 276) who entered the study (NCT00055497).
369635|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
369636|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
369637|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
369638|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
369639|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
369640|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
369641|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
369642|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
369643|NCT01070303|O4|Outcome|Change From Baseline-Week 248|The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
369644|NCT01070303|O3|Outcome|Change From Baseline-Week 200|The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
369645|NCT01070303|O2|Outcome|Change From Baseline-Week 152|The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
369646|NCT01070303|O1|Outcome|Change From Baseline-Week 104|The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
369647|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
369648|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
369649|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
369650|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
369845|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
369652|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
369653|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
369654|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
369655|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
369656|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
369657|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
369658|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
369659|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
369660|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
369661|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
369662|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
369663|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
369664|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
369665|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
369666|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
369667|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
369668|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
369669|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
369670|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
369671|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
369672|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
369673|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
369674|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
369675|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
369714|NCT01070043|O1|Outcome|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
369676|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
369677|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
369678|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
369679|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
369680|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
369681|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
369682|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
369683|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
369684|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
369685|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
369686|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
369687|NCT01070303|E2|Reported Event|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
369688|NCT01070303|E1|Reported Event|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
369689|NCT01070173|B4|Baseline|Total|Total of all reporting groups
369690|NCT01070173|B3|Baseline|Isolated Gastrointestinal Symptoms|Isolated Gastrointestinal Symptoms
369691|NCT01070173|B2|Baseline|Poor Weight Gain (Failure-To-Thrive)|Poor Weight Gain (Failure-To-Thrive)
369692|NCT01070173|B1|Baseline|Short Stature|Poor linear growth
369693|NCT01070173|P3|Participant Flow|Isolated Gastrointestinal Symptoms|Isolated Gastrointestinal Symptoms Group
369694|NCT01070173|P2|Participant Flow|Poor Weight Gain (Failure-To-Thrive)|Poor Weight Gain (Failure-To-Thrive) Group
369695|NCT01070173|P1|Participant Flow|Short Stature|Poor linear growth Group
369696|NCT01070173|O3|Outcome|Isolated Gastrointestinal Symptoms|Isolated Gastrointestinal Symptoms Group
369697|NCT01070173|O2|Outcome|Poor Weight Gain (Failure-To-Thrive)|Poor Weight Gain (Failure-To-Thrive) Group
369698|NCT01070173|O1|Outcome|Short Stature|Poor linear growth Group
369699|NCT01070173|O3|Outcome|Isolated Gastrointestinal Symptoms|Isolated Gastrointestinal Symptoms Group
369700|NCT01070173|O2|Outcome|Poor Weight Gain (Failure-To-Thrive)|Poor Weight Gain (Failure-To-Thrive) Group
369701|NCT01070173|O1|Outcome|Short Stature|Poor linear growth Group
369702|NCT01070173|E3|Reported Event|Isolated Gastrointestinal Symptoms|Isolated Gastrointestinal Symptoms Group
369703|NCT01070173|E2|Reported Event|Poor Weight Gain (Failure-To-Thrive)|Poor Weight Gain (Failure-To-Thrive) Group
369704|NCT01070173|E1|Reported Event|Short Stature|Poor linear growth Group
369705|NCT01070043|B3|Baseline|Total|Total of all reporting groups
369706|NCT01070043|B2|Baseline|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
369707|NCT01070043|B1|Baseline|Amlodipine 5mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
369708|NCT01070043|P3|Participant Flow|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
369709|NCT01070043|P2|Participant Flow|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
369710|NCT01070043|P1|Participant Flow|Run-In Valsartan 80 mg|During run-in period, oral valsartan 80 mg once daily for 4 weeks.
369711|NCT01070043|O2|Outcome|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
369712|NCT01070043|O1|Outcome|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
369713|NCT01070043|O2|Outcome|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
369716|NCT01070043|O1|Outcome|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
369717|NCT01070043|O2|Outcome|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
369718|NCT01070043|O1|Outcome|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
369719|NCT01070043|O2|Outcome|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
369720|NCT01070043|O1|Outcome|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
369721|NCT01070043|E2|Reported Event|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
369722|NCT01070043|E1|Reported Event|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
369723|NCT01069939|B3|Baseline|Total|Total of all reporting groups
369724|NCT01069939|B2|Baseline|Placebo|Placebo once daily oral
369725|NCT01069939|B1|Baseline|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
369726|NCT01069939|P2|Participant Flow|Placebo|Placebo once daily oral
369727|NCT01069939|P1|Participant Flow|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
369728|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
369729|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
369730|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
369731|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
369732|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
369733|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
369734|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
369735|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
369736|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
369737|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
369738|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
369739|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
369740|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
369741|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
369742|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
369743|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
369744|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
369745|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
369746|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
369747|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
369748|NCT01069939|E2|Reported Event|Placebo|Placebo once daily oral
369749|NCT01069939|E1|Reported Event|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
369750|NCT01069900|B3|Baseline|Total|Total of all reporting groups
369751|NCT01069900|B2|Baseline|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
369752|NCT01069900|B1|Baseline|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
369753|NCT01069900|P2|Participant Flow|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
369754|NCT01069900|P1|Participant Flow|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
369755|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
369756|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
369757|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
369758|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
369759|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
369760|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
369761|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
369762|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
369763|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
369764|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
369765|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
369766|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
369767|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
369768|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
369769|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
369770|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
369771|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
369772|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
369773|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
369774|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
369775|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
369776|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
369777|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
369778|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
369779|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
369780|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
369781|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
369782|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
369783|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
369784|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
369785|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
369786|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
369787|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
369788|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
369789|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
369790|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
369791|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
369792|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
369793|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
369794|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
369795|NCT01069900|E2|Reported Event|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
369796|NCT01069900|E1|Reported Event|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5-14 days.
369797|NCT01069861|B1|Baseline|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
369798|NCT01069861|P1|Participant Flow|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 milligram per kilogram (mg/kg) over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg per hour (mg/kg/hr) intravenous infusion up to 14 days, based on the need of individual participant.
369799|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
369800|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
369801|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
369802|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
369803|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
369804|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
369805|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
369806|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
369807|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
369808|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
369809|NCT01069861|E1|Reported Event|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
369810|NCT01069627|B1|Baseline|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
369811|NCT01069627|P1|Participant Flow|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 milligrams/kilogram (mg/kg) intravenously (IV) on Day 1 and fotemustine 100 mg per square meter (mg/m^2) IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
369812|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
369813|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
369814|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
369815|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
369816|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
369817|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
369818|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
369819|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
369820|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
369821|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
369822|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
369823|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
369824|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
369846|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
369825|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
369826|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
369827|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
369828|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
369829|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
369830|NCT01069627|E1|Reported Event|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
369831|NCT01069562|B3|Baseline|Total|Total of all reporting groups
369832|NCT01069562|B2|Baseline|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
369833|NCT01069562|B1|Baseline|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
369834|NCT01069562|P2|Participant Flow|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
369835|NCT01069562|P1|Participant Flow|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
369836|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
369837|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
369838|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
369839|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
369840|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
369841|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
369842|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
369843|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
369844|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
369937|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
369847|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
369848|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
369849|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
369850|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
369851|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
369852|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
369853|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
369854|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
369855|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
369856|NCT01069562|E2|Reported Event|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
369857|NCT01069562|E1|Reported Event|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
369858|NCT01069523|B3|Baseline|Total|Total of all reporting groups
369859|NCT01069523|B2|Baseline|Guanfacine Extended Release|Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
369860|NCT01069523|B1|Baseline|Placebo|Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
369861|NCT01069523|P2|Participant Flow|Guanfacine Extended Release|Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
369862|NCT01069523|P1|Participant Flow|Placebo|Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
369863|NCT01069523|O2|Outcome|Guanfacine|Blinded guanfacine capsule
369864|NCT01069523|O1|Outcome|Placebo|Pill placebo
369865|NCT01069523|O2|Outcome|Guanfacine|Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
369866|NCT01069523|O1|Outcome|Placebo|Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
369867|NCT01069523|E2|Reported Event|Guanfacine Extended Release|Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
369868|NCT01069523|E1|Reported Event|Placebo|Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
369869|NCT01069484|B3|Baseline|Total|Total of all reporting groups
369870|NCT01069484|B2|Baseline|Control|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract correctly, the control group received no further intervention.
369871|NCT01069484|B1|Baseline|Postpartum Pelvic Floor Muscle Training|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract correctly, the training participants attended a supervised exercise class once a week led by an experienced physiotherapist and were prescribed daily home training over a period of 4 months.
369872|NCT01069484|P2|Participant Flow|Control|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract the PFM correctly, the control group participants received no further intervention. They were not discouraged from doing PFMT on their own.
369873|NCT01069484|P1|Participant Flow|Postpartum Pelvic Floor Muscle Training|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract the pelvic floor muscle (PFM) correctly, the training participants attended a supervised exercise class once a week led by an experienced physiotherapist and were prescribed daily home training over a period of 4 months. The PFM exercise protocol followed general principles for strength training; 3 sets 8-12 contractions close to maximum (Bø et al 1990, Haskell 2007). The participants are provided with a DVD of the program (www.corewellness.co.uk). Training adherence at home was recorded in a training diary whereas the physical therapist recorded group session adherence. Training participants were continuously motivated by the physical therapist to keep up their adherence to training classes and home training, and high performance during training was strongly emphasised.
369874|NCT01069484|O2|Outcome|Control|Beyond the customary leaflet and the thorough initial instruction on how to contract correctly, the control group received no further intervention..
369875|NCT01069484|O1|Outcome|Postpartum Pelvic Floor Muscle Training|"Beyond the customary leaflet and the thorough initial instruction on how to contract correctly, the training group attended an exercise intervention for a period of 16 weeks (starting eight 8 weeks after delivery). Once a week the training participants attended a supervised exercise class led by an experienced physical therapist. The exercise class protocol is described in detail by Bø et al (1990) and Mørkved and Bø (1997). Additionally, the training group was prescribed to perform daily pelvic floor muscle training at home (three sets of 8-12 close to maximum contractions).~Training adherence at home was recorded in a training diary, whereas the physical therapist recorded group session adherence."
369876|NCT01069484|O2|Outcome|Control|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract correctly, the control group received no further intervention
369877|NCT01069484|O1|Outcome|Postpartum Pelvic Floor Muscle Training|"Beyond the customary leaflet and the thorough initial instruction on how to contract correctly, the training group attended an exercise intervention for a period of 16 weeks (starting eight 8 weeks after delivery). Once a week the training participants attended a supervised exercise class led by an experienced physical therapist. The exercise class protocol is described in detail by Bø et al (1990) and Mørkved and Bø (1997). Additionally, the training group was prescribed to perform daily pelvic floor muscle training at home (three sets of 8-12 close to maximum contractions).~Training adherence at home was recorded in a training diary, whereas the physical therapist recorded group session adherence."
369878|NCT01069484|E2|Reported Event|Control|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract correctly, the control group received no further intervention
369879|NCT01069484|E1|Reported Event|Postpartum Pelvic Floor Muscle Training|"Beyond the customary leaflet and the thorough initial instruction on how to contract correctly, the training group attended an exercise intervention for a period of 16 weeks (starting eight 8 weeks after delivery). Once a week the training participants attended a supervised exercise class led by an experienced physical therapist. The exercise class protocol is described in detail by Bø et al (1990) and Mørkved and Bø (1997). Additionally, the training group was prescribed to perform daily pelvic floor muscle training at home (three sets of 8-12 close to maximum contractions).~Training adherence at home was recorded in a training diary, whereas the physical therapist recorded group session adherence."
369880|NCT01069419|B1|Baseline|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
369881|NCT01069419|P1|Participant Flow|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
369882|NCT01069419|O1|Outcome|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
369883|NCT01069419|O1|Outcome|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
369884|NCT01069419|O1|Outcome|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
369885|NCT01069419|O1|Outcome|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
369886|NCT01069419|E1|Reported Event|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
369887|NCT01069354|B1|Baseline|Radiesse® Mixed With Lidocaine and Radiesse® Without Lidocaine|"Injectable Dermal Filler. The same 102 participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier containing 3% lidocaine hydrochloride (HCl) and Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl)"
369888|NCT01069354|P1|Participant Flow|Radiesse® Mixed With Lidocaine and Radiesse® Without Lidocaine|"Injectable Dermal Filler. The same 102 participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier containing 3% lidocaine hydrochloride (HCl) and Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl)"
369889|NCT01069354|O1|Outcome|Radiesse® Mixed With Lidocaine and Radiesse® Without Lidocaine|"Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier containing 3% lidocaine hydrochloride (HCl) and without 3% lidocaine hydrochloride (HCl)"
369890|NCT01069354|O2|Outcome|Radiesse® Without Lidocaine|"Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl)"
369891|NCT01069354|O1|Outcome|Radiesse® Mixed With Lidocaine|"Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier containing 3% lidocaine hydrochloride (HCl)"
369892|NCT01069354|O2|Outcome|Radiesse® Without Lidocaine|"Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl)"
369893|NCT01069354|O1|Outcome|Radiesse® Mixed With Lidocaine|"Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier containing 3% lidocaine hydrochloride (HCl)"
369894|NCT01069354|O2|Outcome|Radiesse® Without Lidocaine|"Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl)"
369895|NCT01069354|O1|Outcome|Radiesse® Mixed With Lidocaine|"Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier containing 3% lidocaine hydrochloride (HCl)"
369896|NCT01069354|O2|Outcome|Radiesse® Without Lidocaine|"Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl)"
369897|NCT01069354|O1|Outcome|Radiesse® Mixed With Lidocaine|"Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier containing 3% lidocaine hydrochloride (HCl)"
369934|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
373609|NCT01059760|O1|Outcome|Baseline Value|
369898|NCT01069354|O2|Outcome|Radiesse® Without Lidocaine|"Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl)"
369899|NCT01069354|O1|Outcome|Radiesse® Mixed With Lidocaine|"Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier containing 3% lidocaine hydrochloride (HCl)"
369900|NCT01069354|O2|Outcome|Radiesse® Without Lidocaine|"Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl)"
369901|NCT01069354|O1|Outcome|Radiesse® Mixed With Lidocaine|"Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier containing 3% lidocaine hydrochloride (HCl)"
369902|NCT01069354|O2|Outcome|Radiesse® Without Lidocaine|"Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl)"
369903|NCT01069354|O1|Outcome|Radiesse® Mixed With Lidocaine|"Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier containing 3% lidocaine hydrochloride (HCl)"
369904|NCT01069354|O1|Outcome|Radiesse® Mixed With Lidocaine and Radiesse® Without Lidocaine|"Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier containing 3% lidocaine hydrochloride (HCl) and calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl)"
369905|NCT01069354|O2|Outcome|Radiesse® Without Lidocaine|"Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl)"
369906|NCT01069354|O1|Outcome|Radiesse® Mixed With Lidocaine|"Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier containing 3% lidocaine hydrochloride (HCl)"
369907|NCT01069354|E2|Reported Event|Radiesse® Without Lidocaine|"Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl)"
369908|NCT01069354|E1|Reported Event|Radiesse® Mixed With Lidocaine|"Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).~Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier containing 3% lidocaine hydrochloride (HCl)"
369909|NCT01069341|B1|Baseline|All Subjects With Treatment|All subjects received o.5 mg of ranibizumab injections monthly for 3 months
369910|NCT01069341|P1|Participant Flow|All Subjects With Treatment|All subjects received o.5 mg of ranibizumab injections monthly for 3 months
369911|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
369912|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
369913|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
369914|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
369915|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
369916|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
369917|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
369918|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
369919|NCT01069341|E1|Reported Event|All Subjects With Treatment|All subjects received o.5 mg of ranibizumab injections monthly for 3 months
369920|NCT01069289|B3|Baseline|Total|Total of all reporting groups
369921|NCT01069289|B2|Baseline|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
369922|NCT01069289|B1|Baseline|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
369923|NCT01069289|P2|Participant Flow|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
369924|NCT01069289|P1|Participant Flow|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
369925|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
369926|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
369927|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
369928|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
369929|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
369930|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
369931|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
369932|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
369933|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
372267|NCT01063595|O1|Outcome|Octaplas LG|Participants received 1200 mL of Octaplas LG intravenously once.
369938|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
369939|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
369940|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
369941|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
369942|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
369943|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
369944|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
369945|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
369946|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
369947|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
369948|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
369949|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
369950|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
369951|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
369952|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
369953|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
369954|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
369955|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
369956|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
369957|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
369958|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
369959|NCT01069289|E2|Reported Event|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
369960|NCT01069289|E1|Reported Event|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
369961|NCT01069185|B3|Baseline|Total|Total of all reporting groups
369962|NCT01069185|B2|Baseline|Routine Endotracheal Suctioning|"Endotracheal suctioning every two hours~Routine endotracheal suctioning: Endotracheal suctioning every two hours"
369963|NCT01069185|B1|Baseline|Necessity Endotracheal Suctioning|"Endotracheal suctioning depends on clinical manifestations~Necessity endotracheal suctioning: Endotracheal suctioning depends on clinical manifestations"
369964|NCT01069185|P2|Participant Flow|Routine Endotracheal Suctioning|"Endotracheal suctioning every two hours~Routine endotracheal suctioning: Endotracheal suctioning every two hours"
369965|NCT01069185|P1|Participant Flow|Necessity Endotracheal Suctioning|"Endotracheal suctioning depends on clinical manifestations~Necessity endotracheal suctioning: Endotracheal suctioning depends on clinical manifestations"
369966|NCT01069185|O2|Outcome|Routine Endotracheal Suctioning|"Endotracheal suctioning every two hours~Routine endotracheal suctioning: Endotracheal suctioning every two hours"
369967|NCT01069185|O1|Outcome|Necessity Endotracheal Suctioning|"Endotracheal suctioning depends on clinical manifestations~Necessity endotracheal suctioning: Endotracheal suctioning depends on clinical manifestations"
369968|NCT01069185|O2|Outcome|Routine Endotracheal Suctioning|"Endotracheal suctioning every two hours~Routine endotracheal suctioning: Endotracheal suctioning every two hours"
369969|NCT01069185|O1|Outcome|Necessity Endotracheal Suctioning|"Endotracheal suctioning depends on clinical manifestations~Necessity endotracheal suctioning: Endotracheal suctioning depends on clinical manifestations"
369970|NCT01069185|E2|Reported Event|Routine Endotracheal Suctioning|"Endotracheal suctioning every two hours~Routine endotracheal suctioning: Endotracheal suctioning every two hours"
369971|NCT01069185|E1|Reported Event|Necessity Endotracheal Suctioning|"Endotracheal suctioning depends on clinical manifestations~Necessity endotracheal suctioning: Endotracheal suctioning depends on clinical manifestations"
369972|NCT01069172|B1|Baseline|FS Laser Surgery and CCC Surgery|"Each eye underwent either:~Femtosecond assissisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device (the Catalys System is used for FS Laser Surgery and is an ophthalmic surgical laser system intended for use in cataract surgery).~OR~Ultrasound (U/S) cataract surgery and CCC (continuous curvilinear capsulorhexis), subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens."
369973|NCT01069172|P2|Participant Flow|CCC Surgery|"Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC)~CCC Surgery: Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens."
369974|NCT01069172|P1|Participant Flow|FS Laser Surgery|"For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device.~FS Laser Surgery: The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery."
369975|NCT01069172|O2|Outcome|CCC Surgery|"Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC).~CCC Surgery: Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens."
370235|NCT01068769|O1|Outcome|Regorafenib|Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle
369976|NCT01069172|O1|Outcome|FS Laser Surgery|"For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device.~FS Laser Surgery: The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery."
369977|NCT01069172|O2|Outcome|CCC Surgery|"Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC).~CCC and U/S Surgery: Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens."
369978|NCT01069172|O1|Outcome|FS Laser Surgery|"For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device.~FS Laser Surgery: The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery."
369979|NCT01069172|E2|Reported Event|CCC Surgery|"Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC).~CCC Surgery: Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens."
369980|NCT01069172|E1|Reported Event|FS Laser Surgery|"For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device.~FS Laser Surgery: The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery."
369981|NCT01069120|B3|Baseline|Total|Total of all reporting groups
369982|NCT01069120|B2|Baseline|25 mg Proellex®|Proellex: 1, 25 mg capsule once per day
369983|NCT01069120|B1|Baseline|50 mg Proellex®|Proellex: 2, 25 mg capsules once per day
369984|NCT01069120|P1|Participant Flow|Proellex®|25 or 50 mg capsules once per day
369985|NCT01069120|O2|Outcome|25 mg Proellex®|Proellex: 1, 25 mg capsule once per day
369986|NCT01069120|O1|Outcome|50 mg Proellex®|Proellex: 2, 25 mg capsules once per day
369987|NCT01069120|E2|Reported Event|25 mg Proellex®|Proellex: 1, 25 mg capsule once per day
369988|NCT01069120|E1|Reported Event|50 mg Proellex®|Proellex: 2, 25 mg capsules once per day
369989|NCT01069003|B4|Baseline|Total|Total of all reporting groups
369990|NCT01069003|B3|Baseline|Surveillance Arm|Non randomized subjects followed for total of 24 months
369991|NCT01069003|B2|Baseline|Thienopyridine Therapy|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).~Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg~ASA: 75 mg - 325 mg Aspirin(ASA)"
369992|NCT01069003|B1|Baseline|Placebo Arm|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).~Placebo (12-Month Arm): Placebo~ASA: 75 mg - 325 mg Aspirin(ASA)"
369993|NCT01069003|P3|Participant Flow|Surveillance Arm|Non randomized subjects followed for total of 24 months
369994|NCT01069003|P2|Participant Flow|Thienopyridine Therapy|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).~Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg~ASA: 75 mg - 325 mg Aspirin(ASA)"
369995|NCT01069003|P1|Participant Flow|Placebo|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).~Placebo (12-Month Arm): Placebo~ASA: 75 mg - 325 mg Aspirin(ASA)"
369996|NCT01069003|O3|Outcome|Surveillance Arm|Subjects followed for total of 24 months and not clear for randomization. Subjects who had a death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.
369997|NCT01069003|O2|Outcome|Thienopyridine Therapy|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).~Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg~ASA: 75 mg - 325 mg Aspirin(ASA)"
369998|NCT01069003|O1|Outcome|Placebo Arm|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).~Placebo (12-Month Arm): Placebo~ASA: 75 mg - 325 mg Aspirin(ASA)"
369999|NCT01069003|O3|Outcome|Surveillance Arm|Subjects followed for total of 24 months and not clear for randomization. Subjects who had a death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.
370000|NCT01069003|O2|Outcome|Thienopyridine Therapy|"Subjects without death, myocardial ischemia, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).~Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg~ASA: 75 mg - 325 mg Aspirin(ASA)"
370001|NCT01069003|O1|Outcome|Placebo Arm|"Subjects without death, myocardial ischemia, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).~Placebo (12-Month Arm): Placebo~ASA: 75 mg - 325 mg Aspirin(ASA)"
370002|NCT01069003|O3|Outcome|Surveillance Arm|Subjects followed for total of 24 months and not clear for randomization. Subjects who had a death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.
370003|NCT01069003|O2|Outcome|Thienopyridine Therapy|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).~Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg~ASA: 75 mg - 325 mg Aspirin(ASA)"
370004|NCT01069003|O1|Outcome|Placebo Arm|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).~Placebo (12-Month Arm): Placebo~ASA: 75 mg - 325 mg Aspirin(ASA)"
370005|NCT01069003|E3|Reported Event|Surveillance Arm|Non randomized subjects followed through 24 months
370006|NCT01069003|E2|Reported Event|Thienopyridine Therapy|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).~Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg~ASA: 75 mg - 325 mg Aspirin(ASA)"
370007|NCT01069003|E1|Reported Event|Placebo Arm|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).~Placebo (12-Month Arm): Placebo~ASA: 75 mg - 325 mg Aspirin(ASA)"
370008|NCT01068964|B3|Baseline|Total|Total of all reporting groups
370009|NCT01068964|B2|Baseline|0.03% Bimatoprost and 0.5% Timolol in Separate Bottles|Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
370010|NCT01068964|B1|Baseline|0.03% Bimatoprost/0.5% Timolol in Same Bottle|Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
370011|NCT01068964|P2|Participant Flow|0.03% Bimatoprost and 0.5% Timolol in Separate Bottles|Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
370012|NCT01068964|P1|Participant Flow|0.03% Bimatoprost/0.5% Timolol in Same Bottle|Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
370013|NCT01068964|O2|Outcome|0.03% Bimatoprost and 0.5% Timolol in Separate Bottles|Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
370014|NCT01068964|O1|Outcome|0.03% Bimatoprost/0.5% Timolol in Same Bottle|Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
370015|NCT01068964|E2|Reported Event|0.03% Bimatoprost and 0.5% Timolol in Separate Bottles|Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
370016|NCT01068964|E1|Reported Event|0.03% Bimatoprost/0.5% Timolol in Same Bottle|Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
370017|NCT01068912|B4|Baseline|Total|Total of all reporting groups
370018|NCT01068912|B3|Baseline|Placebo|Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
370019|NCT01068912|B2|Baseline|2: High Dose Favipiravir|Favipiravir: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
370020|NCT01068912|B1|Baseline|1: Low Dose Favipiravir|Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
370021|NCT01068912|P3|Participant Flow|Placebo|Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
370022|NCT01068912|P2|Participant Flow|2: High Dose Favipiravir|Favipiravir: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
370023|NCT01068912|P1|Participant Flow|1: Low Dose Favipiravir|Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
370024|NCT01068912|O3|Outcome|Placebo|Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
370025|NCT01068912|O2|Outcome|2: High Dose Favipiravir|Favipiravir:1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
370026|NCT01068912|O1|Outcome|1: Low Dose Favipiravir|Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
370027|NCT01068912|E3|Reported Event|Placebo|Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
370028|NCT01068912|E2|Reported Event|2: High Dose Favipiravir|Favipiravir: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
370029|NCT01068912|E1|Reported Event|1: Low Dose Favipiravir|Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
370030|NCT01068860|B11|Baseline|Total|Total of all reporting groups
370031|NCT01068860|B10|Baseline|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370032|NCT01068860|B9|Baseline|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370033|NCT01068860|B8|Baseline|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370034|NCT01068860|B7|Baseline|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370035|NCT01068860|B6|Baseline|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370036|NCT01068860|B5|Baseline|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370037|NCT01068860|B4|Baseline|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370151|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
373610|NCT01059760|O3|Outcome|Change When Fed|
370038|NCT01068860|B3|Baseline|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370039|NCT01068860|B2|Baseline|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370040|NCT01068860|B1|Baseline|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370041|NCT01068860|P10|Participant Flow|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370042|NCT01068860|P9|Participant Flow|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370043|NCT01068860|P8|Participant Flow|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370044|NCT01068860|P7|Participant Flow|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370045|NCT01068860|P6|Participant Flow|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370046|NCT01068860|P5|Participant Flow|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370047|NCT01068860|P4|Participant Flow|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370048|NCT01068860|P3|Participant Flow|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370049|NCT01068860|P2|Participant Flow|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370050|NCT01068860|P1|Participant Flow|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370051|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370052|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370053|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370054|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370055|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370075|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370056|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370057|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370058|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370059|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370060|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370061|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370062|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370063|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370064|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370065|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370066|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370067|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370068|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370069|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370070|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370071|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370072|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370073|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370074|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
373611|NCT01059760|O2|Outcome|Change While Fasting|
370076|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370077|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370078|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370079|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370080|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370081|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370082|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370083|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370084|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370085|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370086|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370087|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370088|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370089|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370090|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370091|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370092|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370093|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370094|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
373612|NCT01059760|O1|Outcome|Baseline Value|
370095|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370096|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370097|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370098|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370099|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370100|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370101|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370102|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370103|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370104|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370105|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370106|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370107|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370108|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370109|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370110|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370111|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370112|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370113|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370114|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370115|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370116|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370117|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370118|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370119|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370120|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370121|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370122|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370123|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370124|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370125|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370126|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370127|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370128|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370129|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370130|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370131|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370132|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370133|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370134|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370135|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370136|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370137|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370138|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370139|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370140|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370141|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370142|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370143|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370144|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370145|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370146|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370147|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370148|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370149|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370150|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370236|NCT01068769|E1|Reported Event|Regorafenib|Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle
370237|NCT01068743|B1|Baseline|All Enrolled and Treated Participants|
370152|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370153|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370154|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370155|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370156|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370157|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370158|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370159|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370160|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370161|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370162|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370163|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370164|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370165|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370166|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370167|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370168|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370169|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370278|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
370279|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
370170|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370171|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370172|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370173|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370174|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370175|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370176|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370177|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370178|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370179|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370180|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370181|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370182|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370183|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370184|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370185|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370186|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370187|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370231|NCT01068821|E1|Reported Event|Egg Crate Foam Mattress|Patients will be placed on egg-crate foam mattress instead of a gel pad by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
370502|NCT01068626|O2|Outcome|Placebo for Rosuvastatin|
370188|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370189|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370190|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370191|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370192|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370193|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370194|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370195|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370196|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370197|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370198|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370199|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370200|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370201|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370202|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370203|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370204|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370205|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370206|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370207|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370208|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370209|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370210|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370211|NCT01068860|E10|Reported Event|Placebo in Patients With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370212|NCT01068860|E9|Reported Event|Canakinumab 150 mg in Patients With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
370213|NCT01068860|E8|Reported Event|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370214|NCT01068860|E7|Reported Event|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
370215|NCT01068860|E6|Reported Event|Placebo + Met + Sulfonyl + Thiazolidinedione|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370216|NCT01068860|E5|Reported Event|Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370217|NCT01068860|E4|Reported Event|Placebo + Metforimin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370218|NCT01068860|E3|Reported Event|Canakinumab 150 mg + Metforimin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
370219|NCT01068860|E2|Reported Event|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370220|NCT01068860|E1|Reported Event|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
370221|NCT01068821|B3|Baseline|Total|Total of all reporting groups
370222|NCT01068821|B2|Baseline|Gel Pad|Patients will be placed on gel mattress instead of egg-crate foam mattress by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
370223|NCT01068821|B1|Baseline|Egg Crate Foam Mattress|Patients will be placed on egg-crate foam mattress instead of a gel pad by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
370224|NCT01068821|P2|Participant Flow|Gel Pad|Patients will be placed on gel mattress instead of egg-crate foam mattress by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
370225|NCT01068821|P1|Participant Flow|Egg Crate Foam Mattress|Patients will be placed on egg-crate foam mattress instead of a gel pad by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
370226|NCT01068821|O2|Outcome|Gel Pad|Patient positioned on gel pad during surgery
370227|NCT01068821|O1|Outcome|Egg Crate Foam Mattress|Patient positioned on egg crate foam mattress during surgery
370228|NCT01068821|O2|Outcome|Gel Pad|Patient positioned on gel pad during surgery
370229|NCT01068821|O1|Outcome|Egg Crate Foam Mattress|Patient positioned on egg crate foam mattress during surgery
370230|NCT01068821|E2|Reported Event|Gel Pad|Patients will be placed on gel mattress instead of egg-crate foam mattress by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
370238|NCT01068743|P4|Participant Flow|Treatment Sequence DCAB|Treatment D (period 1): Fixed dose combination (FDC) tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition; Treatment C (period 2): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fed condition; Treatment A (period 3): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition; Treatment B (period 4): FDC tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition.
370239|NCT01068743|P3|Participant Flow|Treatment Sequence CBDA|Treatment C (period 1): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fed condition; Treatment B (period 2): FDC tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition; Treatment D (period 3): Fixed dose combination (FDC) tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition; Treatment A (period 4): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition.
370240|NCT01068743|P2|Participant Flow|Treatment Sequence BACD|Treatment B (period 1): FDC tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition; Treatment A (period 2): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition; Treatment C (period 3): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fed condition; Treatment D (period 4): Fixed dose combination (FDC) tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition.
370241|NCT01068743|P1|Participant Flow|Treatment Sequence ADBC|Treatment A (period 1): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition; Treatment D (period 2): Fixed dose combination (FDC) tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition; Treatment B (period 3): FDC tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition; Treatment C (period 4): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fed condition.
370242|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
370243|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
370244|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
370245|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
370246|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
370247|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
370248|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
370249|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
370250|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
370251|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
370252|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
370253|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
370254|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
370255|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
370256|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
370257|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
370258|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
370259|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
370260|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
370261|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
370262|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
370263|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
370264|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
370265|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
370266|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
370267|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
370268|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
370269|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
370270|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
370271|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
370272|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
370273|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
370274|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
370275|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
370276|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
370277|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
370503|NCT01068626|O1|Outcome|Rosuvastatin|
370280|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
370281|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
370282|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
370283|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
370284|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
370285|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
370286|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition.
370287|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition.
370288|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
370289|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition.
370290|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
370291|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
370292|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
370293|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
370294|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
370295|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
370296|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
370297|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
370298|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
370299|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
370300|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
370301|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
370302|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
370303|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
370304|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
370305|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
370306|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
370307|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
370308|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
370309|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
370310|NCT01068743|E4|Reported Event|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
370311|NCT01068743|E3|Reported Event|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
370312|NCT01068743|E2|Reported Event|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
370313|NCT01068743|E1|Reported Event|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
370314|NCT01068730|B1|Baseline|All Enrolled and Treated Participants|Participants who were randomly assigned to 1 of 4 treatment sequences (ADBC, BACD, CBDA, or DCAB). Treatment A: single oral 500-mg Diabex (metformin) tablet administered under fed condition. Treatment B: single oral 500-mg Glucophage tablet administered under fed condition. Treatment C: single oral 1000-mg Diabex tablet administered under fed condition.Treatment D: single oral 1000-mg Glucophage (metformin) tablet administered under fed condition.
370315|NCT01068730|P4|Participant Flow|Treatment Sequence DCAB|Treatment D (period 1): single oral 1000-mg Glucophage tablet administered under fed condition. Treatment C (period 2): single oral 1000-mg Diabex tablet administered under fed condition. Treatment A (period 3): single oral 500-mg Diabex tablet administered under fed condition. Treatment B (period 4): single oral 500-mg Glucophage tablet administered under fed condition.
370316|NCT01068730|P3|Participant Flow|Treatment Sequence CBDA|Treatment C (period 1): single oral 1000-mg Diabex tablet administered under fed condition. Treatment B (period 2): single oral 500-mg Glucophage tablet administered under fed condition. Treatment D (period 3): single oral 1000-mg Glucophage tablet administered under fed condition. Treatment A (period 4): single oral 500-mg Diabex tablet administered under fed condition.
370317|NCT01068730|P2|Participant Flow|Treatment Sequence BACD|Treatment B (period 1): single oral 500-mg Glucophage tablet administered under fed condition. Treatment A (period 2): single oral 500-mg Diabex tablet administered under fed condition. Treatment C (period 3): single oral 1000-mg Diabex tablet administered under fed condition. Treatment D (period 4): single oral 1000-mg Glucophage tablet administered under fed condition.
370318|NCT01068730|P1|Participant Flow|Treatment Sequence ADBC|Treatment A (period 1): single oral 500-mg Diabex (metformin) tablet administered under fed condition. Treatment D (period 2): single oral 1000-mg Glucophage (metformin) tablet administered under fed condition. Treatment B (period 3): single oral 500-mg Glucophage tablet administered under fed condition. Treatment C (period 4): single oral 1000-mg Diabex tablet administered under fed condition.
370504|NCT01068626|O2|Outcome|Placebo for Rosuvastatin|
370505|NCT01068626|O1|Outcome|Rosuvastatin|
370319|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
370320|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|Single oral dose of 1000 mg Diabex tablet administered in the fed condition
370321|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
370322|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
370323|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
370324|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single oral dose of 1000 mg Diabex tablet administered in the fed condition
370325|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
370326|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
370327|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
370328|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single oral dose of 1000 mg Diabex tablet administered in the fed condition
370329|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
370330|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
370331|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
370332|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single oral dose of 1000 mg Diabex tablet administered in the fed condition
370333|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
370334|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
370335|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
370336|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|Single oral dose of 1000 mg Diabex tablet administered in the fed condition
370337|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|Single oral dose of 500 mg Glucophage tablet administered in the fed condition
370338|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
370339|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
370340|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single oral dose of 1000 mg Diabex tablet administered in the fed condition
370341|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
370342|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
370343|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
370344|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single oral dose of 1000 mg Diabex tablet administered in the fed condition
370345|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
370346|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
370347|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
370348|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single oral dose of 1000 mg Diabex tablet administered in the fed condition
370349|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
370350|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
370351|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
370352|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
370353|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
370354|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
370355|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
370356|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
370357|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
370358|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
370359|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
370360|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
370361|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
370362|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
370363|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
370364|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
370365|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
370366|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
370367|NCT01068730|E4|Reported Event|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
370368|NCT01068730|E3|Reported Event|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
370369|NCT01068730|E2|Reported Event|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
370370|NCT01068730|E1|Reported Event|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
370371|NCT01068717|B1|Baseline|All Treated|All participants who received study medication.
370372|NCT01068717|P4|Participant Flow|Treatment Schedule DCAB|(Treatment D) a single oral dose of 2.5-mg saxagliptin/500- mg metformin FDC administered in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment C) a single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fed state. Then, (Treatment A) a single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment B) a single oral dose of 2.5-mg saxagliptin/500- mg metformin FDC administered in the fasted state.
370373|NCT01068717|P3|Participant Flow|Treatment Schedule CBDA|(Treatment C) A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the fed state, followed by a 7-day (minimum) washout period. Then, (Treatment B) a single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment D) a single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment A) a single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state.
370374|NCT01068717|P2|Participant Flow|Treatment Schedule BACD|(Treatment B) A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment A) a single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment C) a single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fed state. Then, (Treatment D) a single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the fasted state.
370375|NCT01068717|P1|Participant Flow|Treatment Schedule ADBC|(Treatment A) A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment D) a single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment B) a single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment C) a single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fed state.
370376|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
370377|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
370378|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
370379|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
370380|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
370381|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
370382|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
370383|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
370384|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
370385|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
370506|NCT01068626|O2|Outcome|Placebo for Rosuvastatin|
370386|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
370387|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
370388|NCT01068717|O4|Outcome|Treatment D: Saxagliptin and Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
370389|NCT01068717|O3|Outcome|Treatment C: Saxagliptin and Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
370390|NCT01068717|O2|Outcome|Treatment B: Saxagliptin and Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
370391|NCT01068717|O1|Outcome|Treatment A: Saxagliptin and Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
370392|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
370393|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
370394|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
370395|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
370396|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
370397|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
370398|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
370399|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
370400|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
370401|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
370402|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
370403|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
370404|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
370405|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
370406|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
370407|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
370408|NCT01068717|O4|Outcome|Treatment D: Saxagliptin and Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
370409|NCT01068717|O3|Outcome|Treatment C: Saxagliptin and Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
370410|NCT01068717|O2|Outcome|Treatment B: Saxagliptin and Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
370411|NCT01068717|O1|Outcome|Treatment A: Saxagliptin and Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
370507|NCT01068626|O1|Outcome|Rosuvastatin|
370412|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
370413|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
370414|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
370415|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
370416|NCT01068717|O4|Outcome|Treatment D: Saxagliptin and Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
370417|NCT01068717|O3|Outcome|Treatment C: Saxagliptin and Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
370418|NCT01068717|O2|Outcome|Treatment B: Saxagliptin and Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
370419|NCT01068717|O1|Outcome|Treatment A: Saxagliptin and Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
370420|NCT01068717|O4|Outcome|Treatment D: Saxagliptin and Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
370421|NCT01068717|O3|Outcome|Treatment C: Saxagliptin and Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
370422|NCT01068717|O2|Outcome|Treatment B: Saxagliptin and Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
370423|NCT01068717|O1|Outcome|Treatment A: Saxagliptin and Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
370424|NCT01068717|E4|Reported Event|Fed: 2.5mg Saxa/500mg Metformin FDC|
370425|NCT01068717|E3|Reported Event|Fed: 2.5mg Onglyza + 500mg Glucophage|
370426|NCT01068717|E2|Reported Event|Fasted: 2.5mg Saxa/500mg Metformin FDC|
370427|NCT01068717|E1|Reported Event|Fasted: 2.5mg Onglyza + 500mg Glucophage|
370428|NCT01068678|B3|Baseline|Total|Total of all reporting groups
370429|NCT01068678|B2|Baseline|IGlar OD|Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
370430|NCT01068678|B1|Baseline|IDeg 3TW|Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
370431|NCT01068678|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
370432|NCT01068678|P1|Participant Flow|IDeg 3TW|Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
370433|NCT01068678|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
370434|NCT01068678|O1|Outcome|IDeg 3TW|Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
370435|NCT01068678|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
370436|NCT01068678|O1|Outcome|IDeg 3TW|Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
370437|NCT01068678|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
370438|NCT01068678|E1|Reported Event|IDeg 3TW|Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
370439|NCT01068665|B3|Baseline|Total|Total of all reporting groups
370440|NCT01068665|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
370441|NCT01068665|B1|Baseline|IDeg 200 U/mL OD|Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
370442|NCT01068665|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
370508|NCT01068626|E2|Reported Event|Placebo for Rosuvastatin|
370509|NCT01068626|E1|Reported Event|Rosuvastatin|
370510|NCT01068600|B3|Baseline|Total|Total of all reporting groups
370443|NCT01068665|P1|Participant Flow|IDeg 200 U/mL OD|Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
370444|NCT01068665|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
370445|NCT01068665|O1|Outcome|IDeg 200 U/mL OD|Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
370446|NCT01068665|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
370447|NCT01068665|O1|Outcome|IDeg 200 U/mL OD|Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
370448|NCT01068665|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
370449|NCT01068665|E1|Reported Event|IDeg 200 U/mL OD|Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
370450|NCT01068652|B3|Baseline|Total|Total of all reporting groups
370451|NCT01068652|B2|Baseline|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
370452|NCT01068652|B1|Baseline|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
370453|NCT01068652|P2|Participant Flow|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
370454|NCT01068652|P1|Participant Flow|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
370455|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
370456|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
370457|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
370458|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
370459|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
370460|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
370461|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
370511|NCT01068600|B2|Baseline|Placebo|Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
370462|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
370463|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
370464|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
370465|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
370466|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
370467|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
370468|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
370469|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
370470|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
370471|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
370472|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
370473|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
370474|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
370475|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
370476|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
370540|NCT01068509|O1|Outcome|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
370477|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
370478|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
370479|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
370480|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
370481|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
370482|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
370483|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
370484|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
370485|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
370486|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
370487|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
370488|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
370489|NCT01068652|E2|Reported Event|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
370490|NCT01068652|E1|Reported Event|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
370491|NCT01068626|B3|Baseline|Total|Total of all reporting groups
370492|NCT01068626|B2|Baseline|Placebo for Rosuvastatin|
370493|NCT01068626|B1|Baseline|Rosuvastatin|
370494|NCT01068626|P2|Participant Flow|Placebo for Rosuvastatin|
370495|NCT01068626|P1|Participant Flow|Rosuvastatin|
370496|NCT01068626|O2|Outcome|Placebo for Rosuvastatin|
370497|NCT01068626|O1|Outcome|Rosuvastatin|
370498|NCT01068626|O2|Outcome|Placebo for Rosuvastatin|
370499|NCT01068626|O1|Outcome|Rosuvastatin|
370500|NCT01068626|O2|Outcome|Placebo for Rosuvastatin|
370501|NCT01068626|O1|Outcome|Rosuvastatin|
370512|NCT01068600|B1|Baseline|Indacaterol 75 µg|Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
370513|NCT01068600|P2|Participant Flow|Placebo|Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
370514|NCT01068600|P1|Participant Flow|Indacaterol 75 µg|Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
370515|NCT01068600|O2|Outcome|Placebo|Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
370516|NCT01068600|O1|Outcome|Indacaterol 75 µg|Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
370517|NCT01068600|O2|Outcome|Placebo|Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
370518|NCT01068600|O1|Outcome|Indacaterol 75 µg|Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
370519|NCT01068600|E2|Reported Event|Placebo|Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
370520|NCT01068600|E1|Reported Event|Indacaterol 75 µg|Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
370521|NCT01068548|B3|Baseline|Total|Total of all reporting groups
370522|NCT01068548|B2|Baseline|Arm 2|"post-implementation of computer based intervention~reminder: computer based reminder to change patients from IV to oral antibiotics based on evidence based clinical practice guidelines"
370523|NCT01068548|B1|Baseline|Arm 1|pre-implementation of computer based intervention
370524|NCT01068548|P2|Participant Flow|Arm 2|"post-implementation of computer based intervention~reminder: computer based reminder to change patients from IV to oral antibiotics based on evidence based clinical practice guidelines"
370525|NCT01068548|P1|Participant Flow|Arm 1|pre-implementation of computer based intervention
370526|NCT01068548|O2|Outcome|Arm 2|"post-implementation of computer based intervention~reminder: computer based reminder to change patients from IV to oral antibiotics based on evidence based clinical practice guidelines"
370527|NCT01068548|O1|Outcome|Arm 1|pre-implementation of computer based intervention
370528|NCT01068548|E2|Reported Event|Arm 2|"post-implementation of computer based intervention~reminder: computer based reminder to change patients from IV to oral antibiotics based on evidence based clinical practice guidelines"
370529|NCT01068548|E1|Reported Event|Arm 1|pre-implementation of computer based intervention
370530|NCT01068509|B4|Baseline|Total|Total of all reporting groups
370531|NCT01068509|B3|Baseline|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
370532|NCT01068509|B2|Baseline|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
370533|NCT01068509|B1|Baseline|Non-randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs. The 6-8 injections contained ~ 60 × 10^6 dendritic cells. Following evaluation after the first dose, participants received additional injections as described for the randomized Cvac group below.
370534|NCT01068509|P3|Participant Flow|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
370535|NCT01068509|P2|Participant Flow|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
370536|NCT01068509|P1|Participant Flow|Non-randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs. The 6-8 injections contained ~ 60 × 10^6 dendritic cells. Following evaluation after the first dose, participants received additional injections as described for the randomized Cvac group below.
370537|NCT01068509|O2|Outcome|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
370538|NCT01068509|O1|Outcome|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
370539|NCT01068509|O2|Outcome|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
370541|NCT01068509|O2|Outcome|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
373613|NCT01059760|O3|Outcome|Change When Fed|
370542|NCT01068509|O1|Outcome|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
370543|NCT01068509|O2|Outcome|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
370544|NCT01068509|O1|Outcome|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
370545|NCT01068509|E3|Reported Event|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
370546|NCT01068509|E2|Reported Event|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
370547|NCT01068509|E1|Reported Event|Non-randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs. The 6-8 injections contained ~ 60 × 10^6 dendritic cells. Following evaluation after the first dose, participants received additional injections as described for the randomized Cvac group below.
370548|NCT01068418|B1|Baseline|Vitamin D3|This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
370549|NCT01068418|P1|Participant Flow|Vitamin D3|This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
370550|NCT01068418|O1|Outcome|Vitamin D3|This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
370551|NCT01068418|O1|Outcome|Vitamin D3|This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
370552|NCT01068418|E1|Reported Event|Vitamin D3|This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
370553|NCT01068262|B5|Baseline|Total|Total of all reporting groups
370554|NCT01068262|B4|Baseline|Healthy Postmenopausal Females: Placebo (Panel B)|Healthy postmenopausal female participants randomized to placebo administered Qw for 4 consecutive weeks
370555|NCT01068262|B3|Baseline|Healthy Postmenopausal Females: Odanacatib (Panel B)|Healthy postmenopausal female participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
370556|NCT01068262|B2|Baseline|Healthy Males: Placebo (Panel A)|Healthy male participants randomized to placebo administered Qw for 4 consecutive weeks.
370557|NCT01068262|B1|Baseline|Healthy Males: Odanacatib (Panel A)|Healthy male participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
370558|NCT01068262|P4|Participant Flow|Healthy Postmenopausal Females: Placebo (Panel B)|Healthy postmenopausal female participants randomized to placebo administered Qw for 4 consecutive weeks
370559|NCT01068262|P3|Participant Flow|Healthy Postmenopausal Females: Odanacatib (Panel B)|Healthy postmenopausal female participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
370560|NCT01068262|P2|Participant Flow|Healthy Males: Placebo (Panel A)|Healthy male participants randomized to placebo administered Qw for 4 consecutive weeks.
370561|NCT01068262|P1|Participant Flow|Healthy Males: Odanacatib (Panel A)|Healthy male participants randomized to Odanacatib 50 mg tablet administered once weekly (Qw) for 4 consecutive weeks
370562|NCT01068262|O4|Outcome|Placebo in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of placebo administered Qw for 4 consecutive weeks
370563|NCT01068262|O3|Outcome|Odnacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
370564|NCT01068262|O2|Outcome|Placebo in Males (Panel A)|Healthy males received oral doses of placebo administered Qw for 4 consecutive weeks
370565|NCT01068262|O1|Outcome|Odanacatib (MK-0822) in Males (Panel A)|Healthy males received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
370566|NCT01068262|O4|Outcome|Postmenopausal Females: Placebo (Panel B)|Healthy postmenopausal females received oral doses of placebo administered Qw for 4 consecutive weeks
370567|NCT01068262|O3|Outcome|Odnacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
370568|NCT01068262|O2|Outcome|Placebo in Males (Panel A)|Healthy males received oral doses of placebo administered Qw for 4 consecutive weeks
370569|NCT01068262|O1|Outcome|Odanacatib (MK-0822) in Males (Panel A)|Healthy males received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
370570|NCT01068262|O2|Outcome|Odanacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
370571|NCT01068262|O1|Outcome|Odnacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
370572|NCT01068262|O2|Outcome|Odanacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
370573|NCT01068262|O1|Outcome|Odnacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
370574|NCT01068262|O2|Outcome|Odanacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
370575|NCT01068262|O1|Outcome|Odnacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
370576|NCT01068262|O2|Outcome|Odanacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
370577|NCT01068262|O1|Outcome|Odnacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
370578|NCT01068262|O2|Outcome|Odanacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
370579|NCT01068262|O1|Outcome|Odnacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
370580|NCT01068262|O4|Outcome|Placebo in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of placebo administered Qw for 4 consecutive weeks
370581|NCT01068262|O3|Outcome|Odnacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
370582|NCT01068262|O2|Outcome|Placebo in Males (Panel A)|Healthy males received oral doses of placebo administered Qw for 4 consecutive weeks
370583|NCT01068262|O1|Outcome|Odanacatib (MK-0822) in Males (Panel A)|Healthy males received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
370584|NCT01068262|E4|Reported Event|Postmenopausal Females: Placebo (Panel B)|Healthy postmenopausal female participants randomized to placebo administered Qw for 4 consecutive weeks
370585|NCT01068262|E3|Reported Event|Postmenopausal Females: Odanacatib 50 mg (Panel B)|Healthy postmenopausal female participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
370586|NCT01068262|E2|Reported Event|Healthy Males: Placebo (Panel A)|Healthy male participants randomized to placebo administered Qw for 4 consecutive weeks
370587|NCT01068262|E1|Reported Event|Healthy Males: Odanacatib 50 mg (Panel A)|Healthy male participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
370588|NCT01068158|B3|Baseline|Total|Total of all reporting groups
370589|NCT01068158|B2|Baseline|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
370590|NCT01068158|B1|Baseline|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
370591|NCT01068158|P2|Participant Flow|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
370592|NCT01068158|P1|Participant Flow|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
370593|NCT01068158|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
370594|NCT01068158|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
370595|NCT01068158|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
370596|NCT01068158|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
370597|NCT01068158|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
370598|NCT01068158|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
370599|NCT01068158|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
370600|NCT01068158|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
370601|NCT01068158|E2|Reported Event|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
370602|NCT01068158|E1|Reported Event|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
370603|NCT01067976|B1|Baseline|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced MRM, followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg bw [0.1 ml/kg bw] as an i.v. injection at a rate of 2 ml/sec. UMRM and CMRM image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective XRM was added and evaluated together with the UMRM images.
370604|NCT01067976|P1|Participant Flow|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection (i.v.) at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
370605|NCT01067976|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced MRM, followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg bw [0.1 ml/kg bw] as an i.v. injection at a rate of 2 ml/sec. UMRM and CMRM image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective XRM was added and evaluated together with the UMRM images.
370606|NCT01067976|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|
370607|NCT01067976|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced MRM, followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg bw [0.1 ml/kg bw] as an i.v. injection at a rate of 2 ml/sec. UMRM and CMRM image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective XRM was added and evaluated together with the UMRM images.
370608|NCT01067976|O1|Outcome|CMRM|
370609|NCT01067976|O1|Outcome|CMRM|
370610|NCT01067976|O1|Outcome|CMRM|
370611|NCT01067976|O1|Outcome|CMRM vs UMRM|
370612|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
370613|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
370614|NCT01067976|O1|Outcome|CMRM vs UMRM|
370615|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
370616|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
370617|NCT01067976|O1|Outcome|CMRM vs UMRM|
370618|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
370619|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
370620|NCT01067976|O1|Outcome|CMRM vs UMRM|
370621|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
370622|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
370623|NCT01067976|O1|Outcome|CMRM vs UMRM|
370624|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
370625|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
370648|NCT01067976|O2|Outcome|CMRM|After the administration of study drug, enhanced breast MRI were performed.
370649|NCT01067976|O1|Outcome|UMRM|Before the administration of study drug unenhanced breast MRI (UMRM) were performed.
370650|NCT01067976|O3|Outcome|CMRM vs CMRM+XRM|
370651|NCT01067976|O2|Outcome|CMRM vs XRM|
370652|NCT01067976|O1|Outcome|CMRM vs UMRM|
370653|NCT01067976|O3|Outcome|CMRM vs CMRM+XRM|
370654|NCT01067976|O2|Outcome|CMRM vs XRM|
370655|NCT01067976|O1|Outcome|CMRM vs UMRM|
370656|NCT01067976|O1|Outcome|CMRM|
370657|NCT01067976|O1|Outcome|CMRM|
370658|NCT01067976|O2|Outcome|CMRM|
370659|NCT01067976|O1|Outcome|UMRM|
370660|NCT01067976|O1|Outcome|CMRM vs UMRM|
370661|NCT01067976|E1|Reported Event|Gadobutrol (Gadavist, BAY 86-4875)|Participants first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
370662|NCT01067846|B3|Baseline|Total|Total of all reporting groups
370663|NCT01067846|B2|Baseline|Placebo and Cognitive Behavioral Therapy|"Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.~Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
370664|NCT01067846|B1|Baseline|DCS and Cognitive Behavioral Therapy|"Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.~Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
370665|NCT01067846|P2|Participant Flow|Placebo and Cognitive Behavioral Therapy|"Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.~Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
370666|NCT01067846|P1|Participant Flow|DCS and Cognitive Behavioral Therapy|"Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.~Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
370667|NCT01067846|O2|Outcome|Placebo and Cognitive Behavioral Therapy|"Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.~Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
370668|NCT01067846|O1|Outcome|DCS and Cognitive Behavioral Therapy|"Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.~Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
370669|NCT01067846|O2|Outcome|Placebo and Cognitive Behavioral Therapy|"Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.~Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
370670|NCT01067846|O1|Outcome|DCS and Cognitive Behavioral Therapy|"Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.~Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
370671|NCT01067846|E2|Reported Event|Placebo and Cognitive Behavioral Therapy|"Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.~Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
370672|NCT01067846|E1|Reported Event|DCS and Cognitive Behavioral Therapy|"Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.~Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
370673|NCT01067781|B5|Baseline|Total|Total of all reporting groups
370674|NCT01067781|B4|Baseline|Group 4: 0μg LT, Swab|"Two vaccination regimen with a placebo patch (with swabbing)~Placebo: Travelers' Diarrhea Vaccine System"
370675|NCT01067781|B3|Baseline|Group 3: 0μg LT, No Swab|"Two vaccination regimen with a placebo patch (no swabbing)~Placebo: Travelers' Diarrhea Vaccine System"
370676|NCT01067781|B2|Baseline|Group 2: 37.5μg LT, Swab|"Two vaccination regimen with an LT patch (with swabbing)~Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
370677|NCT01067781|B1|Baseline|Group 1: 37.5μg LT, No Swab|"Two vaccination regimen with an LT patch (no swabbing)~Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
370678|NCT01067781|P4|Participant Flow|Group 4: 0μg LT, Swab|"Two vaccination regimen with a placebo patch (with swabbing)~Placebo: Travelers' Diarrhea Vaccine System"
370679|NCT01067781|P3|Participant Flow|Group 3: 0μg LT, No Swab|"Two vaccination regimen with a placebo patch (no swabbing)~Placebo: Travelers' Diarrhea Vaccine System"
370680|NCT01067781|P2|Participant Flow|Group 2: 37.5μg LT, Swab|"Two vaccination regimen with an LT patch (with swabbing)~Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
370681|NCT01067781|P1|Participant Flow|Group 1: 37.5μg LT, No Swab|"Two vaccination regimen with an LT patch (no swabbing)~Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
370682|NCT01067781|O2|Outcome|Group 3 & 4 Combined: Placebo Patch (0µg LT)|with or without swabbing
370683|NCT01067781|O1|Outcome|Group 1 & 2 Combined: 37.5µg LT Patch|with or without swabbing
370684|NCT01067781|E4|Reported Event|Group 4: 0μg LT, Swab|"Two vaccination regimen with a placebo patch (with swabbing)~Placebo: Travelers' Diarrhea Vaccine System"
370685|NCT01067781|E3|Reported Event|Group 3: 0μg LT, No Swab|"Two vaccination regimen with a placebo patch (no swabbing)~Placebo: Travelers' Diarrhea Vaccine System"
370686|NCT01067781|E2|Reported Event|Group 2: 37.5μg LT, Swab|"Two vaccination regimen with an LT patch (with swabbing)~Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
370687|NCT01067781|E1|Reported Event|Group 1: 37.5μg LT, No Swab|"Two vaccination regimen with an LT patch (no swabbing)~Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
370688|NCT01067768|B3|Baseline|Total|Total of all reporting groups
370689|NCT01067768|B2|Baseline|Control Group|In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
370690|NCT01067768|B1|Baseline|Daily Review|In the intervention group a nurse reviewed daily, by using a checklist designed for this study, the indications and pertinence of the catheter. If it was not indicated she asked the doctor to order the removal of the catheter, but the doctor would make the final decision.
370691|NCT01067768|P2|Participant Flow|Control Group|In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
370692|NCT01067768|P1|Participant Flow|Daily Review|In the intervention group a nurse reviewed daily, by using a checklist designed for this study, the indications and pertinence of the catheter. If it was not indicated she asked the doctor to order the removal of the catheter, but the doctor would make the final decision.
370693|NCT01067768|O2|Outcome|Control Group|In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
370694|NCT01067768|O1|Outcome|Daily Review|Daily monitoring of catheter indication
370695|NCT01067768|O2|Outcome|Control Group|In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
370696|NCT01067768|O1|Outcome|Daily Review|Daily monitoring of catheter indication
370697|NCT01067768|E2|Reported Event|Control Group|In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
370698|NCT01067768|E1|Reported Event|Daily Review|In the intervention group a nurse reviewed daily, by using a checklist designed for this study, the indications and pertinence of the catheter. If it was not indicated she asked the doctor to order the removal of the catheter, but the doctor would make the final decision.
370699|NCT01067716|B4|Baseline|Total|Total of all reporting groups
370700|NCT01067716|B3|Baseline|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
370701|NCT01067716|B2|Baseline|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
370702|NCT01067716|B1|Baseline|Myopia With or Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
370703|NCT01067716|P3|Participant Flow|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
370704|NCT01067716|P2|Participant Flow|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
370705|NCT01067716|P1|Participant Flow|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
370706|NCT01067716|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
370707|NCT01067716|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
370708|NCT01067716|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
370709|NCT01067716|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
370710|NCT01067716|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
370711|NCT01067716|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
370712|NCT01067716|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
370713|NCT01067716|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
370714|NCT01067716|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
370715|NCT01067716|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
370716|NCT01067716|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
370717|NCT01067716|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
370718|NCT01067716|E3|Reported Event|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
370719|NCT01067716|E2|Reported Event|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
370720|NCT01067716|E1|Reported Event|Myopia With or Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
370721|NCT01067456|B3|Baseline|Total|Total of all reporting groups
370750|NCT01067352|E3|Reported Event|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
370722|NCT01067456|B2|Baseline|Comprehensive Cardiothoracic CT Arm|"Subjects in this arm receive a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.~Comprehensive Cardiothoracic Dual Source CT (DSCT) arm: Subjects in this arm will receive the comprehensive cardiothoracic DSCT to rule out aortic dissection/pulmonary embolism/acute coronary syndrome in a single scan."
370723|NCT01067456|B1|Baseline|Dedicated CT Arm|Subjects in this arm will continue to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
370724|NCT01067456|P2|Participant Flow|Comprehensive Cardiothoracic CT Arm|Subjects in this arm receive a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.
370725|NCT01067456|P1|Participant Flow|Dedicated CT Arm|Subjects in this arm will continue to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
370726|NCT01067456|O2|Outcome|Comprehensive Cardiothoracic CT Arm|That is the interventional arm with the new protocol
370727|NCT01067456|O1|Outcome|Dedicated CT Arm|Standard CT either cardiac, PE or aortic dissection CT
370728|NCT01067456|O2|Outcome|Comprehensive Cardiothoracic CT Arm|That is the interventional arm with the new protocol
370729|NCT01067456|O1|Outcome|Dedicated CT Arm|Standard CT either cardiac, PE or aortic dissection CT
370730|NCT01067456|O2|Outcome|Comprehensive Cardiothoracic CT Arm|"Subjects in this arm receive a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.~Comprehensive Cardiothoracic DSCT arm: Subjects in this arm will receive the comprehensive cardiothoracic DSCT to rule out aortic dissection/pulmonary embolism/acute coronary syndrome in a single scan."
370731|NCT01067456|O1|Outcome|Dedicated CT Arm|Subjects in this arm will continue to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
370732|NCT01067456|E2|Reported Event|Comprehensive Cardiothoracic CT Arm|Subjects in this arm received a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.
370733|NCT01067456|E1|Reported Event|Dedicated CT Arm|Subjects in this arm continued to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
370734|NCT01067352|B4|Baseline|Total|Total of all reporting groups
370735|NCT01067352|B3|Baseline|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
370736|NCT01067352|B2|Baseline|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
370737|NCT01067352|B1|Baseline|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
370738|NCT01067352|P3|Participant Flow|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
370739|NCT01067352|P2|Participant Flow|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
370740|NCT01067352|P1|Participant Flow|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
370741|NCT01067352|O3|Outcome|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
370742|NCT01067352|O2|Outcome|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
370743|NCT01067352|O1|Outcome|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
370744|NCT01067352|O3|Outcome|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
370745|NCT01067352|O2|Outcome|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
370746|NCT01067352|O1|Outcome|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
370747|NCT01067352|O3|Outcome|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
370748|NCT01067352|O2|Outcome|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
370749|NCT01067352|O1|Outcome|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
370864|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
370751|NCT01067352|E2|Reported Event|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
370752|NCT01067352|E1|Reported Event|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
370753|NCT01067339|B3|Baseline|Total|Total of all reporting groups
370754|NCT01067339|B2|Baseline|Placebo|Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
370755|NCT01067339|B1|Baseline|Darapladib|Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
370756|NCT01067339|P2|Participant Flow|Placebo|Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
370757|NCT01067339|P1|Participant Flow|Darapladib|Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
370758|NCT01067339|O2|Outcome|Placebo|Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
370759|NCT01067339|O1|Outcome|Darapladib|Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
370760|NCT01067339|O2|Outcome|Placebo|Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
370761|NCT01067339|O1|Outcome|Darapladib|Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
370762|NCT01067339|E2|Reported Event|Placebo|Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
370763|NCT01067339|E1|Reported Event|Darapladib|Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
370764|NCT01067326|B3|Baseline|Total|Total of all reporting groups
370765|NCT01067326|B2|Baseline|Placebo|"1 pill per day by mouth for 4 months. Not all baseline data were available from started subjects, therefore only baseline data for completed subjects is presented."
370766|NCT01067326|B1|Baseline|Aliskiren|"150 mg Aliskiren once daily for a period of 4 months. Not all baseline data were available from started subjects, therefore only baseline data for completed subjects is presented."
370767|NCT01067326|P2|Participant Flow|Placebo|1 pill per day by mouth for 4 months.
370768|NCT01067326|P1|Participant Flow|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
370769|NCT01067326|O2|Outcome|Placebo|1 pill per day by mouth for 4 months.
370770|NCT01067326|O1|Outcome|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
370771|NCT01067326|O2|Outcome|Placebo|1 pill per day by mouth for 4 months.
370772|NCT01067326|O1|Outcome|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
370773|NCT01067326|O2|Outcome|Placebo|1 pill per day by mouth for 4 months.
370774|NCT01067326|O1|Outcome|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
370775|NCT01067326|O2|Outcome|Placebo|1 pill per day by mouth for 4 months.
370776|NCT01067326|O1|Outcome|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
370777|NCT01067326|E2|Reported Event|Placebo|1 pill per day by mouth for 4 months.
370778|NCT01067326|E1|Reported Event|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
370779|NCT01067105|B1|Baseline|Ciclesonide|ciclesonide HFA 160 μg once daily
370780|NCT01067105|P1|Participant Flow|Ciclesonide|ciclesonide HFA 160 μg once daily
370781|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
370782|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
370783|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
370784|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
370785|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
370786|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
370787|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
370788|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
370789|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
370790|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
370791|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
370792|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
370793|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
370794|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
370795|NCT01067105|E1|Reported Event|Ciclesonide|ciclesonide HFA 160 μg once daily
370796|NCT01066923|B5|Baseline|Total|Total of all reporting groups
370797|NCT01066923|B4|Baseline|Daily Placebo, Passive Cool, Acute Placebo|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy~Acute placebo: Placebo comparator for acute aspirin therapy"
370798|NCT01066923|B3|Baseline|Daily Placebo, Passive Cool, Acute ASA|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy"
370799|NCT01066923|B2|Baseline|Daily ASA, Passive Cool, Acute Placebo|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Passive cooling: Removing protective garments for passive cooling following exercise~Acute placebo: Placebo comparator for acute aspirin therapy"
370865|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
370800|NCT01066923|B1|Baseline|Daily ASA, Passive Cool, Acute ASA|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise"
370801|NCT01066923|P4|Participant Flow|Daily Placebo, Passive Cool, Acute Placebo|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy~Acute placebo: Placebo comparator for acute aspirin therapy"
370802|NCT01066923|P3|Participant Flow|Daily Placebo, Passive Cool, Acute ASA|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy"
370803|NCT01066923|P2|Participant Flow|Daily ASA, Passive Cool, Acute Placebo|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Passive cooling: Removing protective garments for passive cooling following exercise~Acute placebo: Placebo comparator for acute aspirin therapy"
370804|NCT01066923|P1|Participant Flow|Daily ASA, Passive Cool, Acute ASA|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise"
370805|NCT01066923|O4|Outcome|Daily Placebo, Passive Cool, Acute Placebo|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy~Acute placebo: Placebo comparator for acute aspirin therapy"
370806|NCT01066923|O3|Outcome|Daily Placebo, Passive Cool, Acute ASA|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy"
370807|NCT01066923|O2|Outcome|Daily ASA, Passive Cool, Acute Placebo|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Passive cooling: Removing protective garments for passive cooling following exercise~Acute placebo: Placebo comparator for acute aspirin therapy"
370808|NCT01066923|O1|Outcome|Daily ASA, Passive Cool, Acute ASA|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise"
370809|NCT01066923|O4|Outcome|Daily Placebo, Passive Cool, Acute Placebo|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy~Acute placebo: Placebo comparator for acute aspirin therapy"
370810|NCT01066923|O3|Outcome|Daily Placebo, Passive Cool, Acute ASA|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy"
370811|NCT01066923|O2|Outcome|Daily ASA, Passive Cool, Acute Placebo|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Passive cooling: Removing protective garments for passive cooling following exercise~Acute placebo: Placebo comparator for acute aspirin therapy"
370812|NCT01066923|O1|Outcome|Daily ASA, Passive Cool, Acute ASA|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise"
370813|NCT01066923|O4|Outcome|Daily Placebo, Passive Cool, Acute Placebo|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy~Acute placebo: Placebo comparator for acute aspirin therapy"
370814|NCT01066923|O3|Outcome|Daily Placebo, Passive Cool, Acute ASA|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy"
370815|NCT01066923|O2|Outcome|Daily ASA, Passive Cool, Acute Placebo|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Passive cooling: Removing protective garments for passive cooling following exercise~Acute placebo: Placebo comparator for acute aspirin therapy"
370816|NCT01066923|O1|Outcome|Daily ASA, Passive Cool, Acute ASA|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise"
370866|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
373614|NCT01059760|O2|Outcome|Change While Fasting|
370817|NCT01066923|O4|Outcome|Daily Placebo, Passive Cool, Acute Placebo|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy~Acute placebo: Placebo comparator for acute aspirin therapy"
370818|NCT01066923|O3|Outcome|Daily Placebo, Passive Cool, Acute ASA|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy"
370819|NCT01066923|O2|Outcome|Daily ASA, Passive Cool, Acute Placebo|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Passive cooling: Removing protective garments for passive cooling following exercise~Acute placebo: Placebo comparator for acute aspirin therapy"
370820|NCT01066923|O1|Outcome|Daily ASA, Passive Cool, Acute ASA|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise"
370821|NCT01066923|E4|Reported Event|Daily Placebo, Passive Cool, Acute Placebo|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy~Acute placebo: Placebo comparator for acute aspirin therapy"
370822|NCT01066923|E3|Reported Event|Daily Placebo, Passive Cool, Acute ASA|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy"
370823|NCT01066923|E2|Reported Event|Daily ASA, Passive Cool, Acute Placebo|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Passive cooling: Removing protective garments for passive cooling following exercise~Acute placebo: Placebo comparator for acute aspirin therapy"
370824|NCT01066923|E1|Reported Event|Daily ASA, Passive Cool, Acute ASA|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise"
370825|NCT01066897|B3|Baseline|Total|Total of all reporting groups
370826|NCT01066897|B2|Baseline|Healthy Controls|Non depressed, non treatment comparison group from baseline
370827|NCT01066897|B1|Baseline|Pramipexole|"Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.~Pramipexole: Patients will received increasing dose of pramipexole"
370828|NCT01066897|P2|Participant Flow|Healthy Controls|Non depressed, non treatment comparison group
370829|NCT01066897|P1|Participant Flow|Pramipexole|"Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.~Pramipexole: Patients will received increasing dose of pramipexole"
370830|NCT01066897|O2|Outcome|Healthy Controls|Non depressed, non treatment comparison group
370831|NCT01066897|O1|Outcome|Pramipexole|"Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.~Pramipexole: Patients will received increasing dose of pramipexole"
370832|NCT01066897|O2|Outcome|Healthy Controls|Non depressed, non-intervention comparison group
370833|NCT01066897|O1|Outcome|Pramipexole|"Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.~Pramipexole: Patients will received increasing dose of pramipexole"
370867|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
370868|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
370869|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
370834|NCT01066897|O1|Outcome|Pramipexole|"Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.~Pramipexole: Patients will received increasing dose of pramipexole"
370835|NCT01066897|O2|Outcome|Healthy Controls Who Did Not Take Medication|
370836|NCT01066897|O1|Outcome|Pramipexole|"Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.~Pramipexole: Patients will received increasing dose of pramipexole"
370837|NCT01066897|E1|Reported Event|Pramipexole|"Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.~Pramipexole: Patients will received increasing dose of pramipexole"
370838|NCT01066871|B5|Baseline|Total|Total of all reporting groups
370839|NCT01066871|B4|Baseline|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
370840|NCT01066871|B3|Baseline|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
370841|NCT01066871|B2|Baseline|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
370842|NCT01066871|B1|Baseline|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
370843|NCT01066871|P4|Participant Flow|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
370844|NCT01066871|P3|Participant Flow|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
370845|NCT01066871|P2|Participant Flow|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
370846|NCT01066871|P1|Participant Flow|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
370847|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
370848|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
370849|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
370850|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
370851|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
370852|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
370853|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
370854|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
370855|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
370856|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
370857|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
370858|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
370859|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
370860|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
370861|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
370862|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
370863|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
370870|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
370871|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
370872|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
370873|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
370874|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
370875|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
370876|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
370877|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
370878|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
370879|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
370880|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
370881|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
370882|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
370883|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
370884|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
370885|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
370886|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
370887|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
370888|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
370889|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
370890|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
370891|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin AS902330 was administered as intra-articular injection once every week for 3 consecutive weeks.
370892|NCT01066871|O3|Outcome|AS902330 100 mcg|AS902330 was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
370893|NCT01066871|O2|Outcome|AS902330 30 mcg|AS902330 was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
370894|NCT01066871|O1|Outcome|AS902330 10 mcg|AS902330 was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
370895|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
370896|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
370897|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
370898|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was be administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
370899|NCT01066871|E4|Reported Event|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
370900|NCT01066871|E3|Reported Event|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
370901|NCT01066871|E2|Reported Event|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
370902|NCT01066871|E1|Reported Event|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
370903|NCT01066819|B7|Baseline|Total|Total of all reporting groups
370904|NCT01066819|B6|Baseline|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370905|NCT01066819|B5|Baseline|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371280|NCT01066104|E2|Reported Event|Xolair (Omalizumab)|Xolair (omalizumab): two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
370906|NCT01066819|B4|Baseline|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370907|NCT01066819|B3|Baseline|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370908|NCT01066819|B2|Baseline|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370909|NCT01066819|B1|Baseline|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370910|NCT01066819|P6|Participant Flow|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370911|NCT01066819|P5|Participant Flow|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370912|NCT01066819|P4|Participant Flow|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370913|NCT01066819|P3|Participant Flow|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370914|NCT01066819|P2|Participant Flow|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370915|NCT01066819|P1|Participant Flow|Genotype 1 (G1)|Eligible participants with serologically proven Chronic hepatitis C (CHC) (Genotype 1) who received Pegylated Interferon (PEG-IFN) alfa-2a (PEGASYS®) or PEG-IFN alfa-2b (PegIntron®) plus ribavirin for up to 48 weeks according to the standard of care and in line with summaries of product characteristics (SPCs)/local labeling were observed.
370916|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370917|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370918|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370919|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370920|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370921|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370922|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370923|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370924|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370925|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370926|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370927|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370928|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370929|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370930|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371281|NCT01066104|E1|Reported Event|Xolair Placebo|Xolair placebo: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
370931|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370932|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370933|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370934|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370935|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370936|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370937|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370938|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370939|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370940|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370941|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370942|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370943|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370944|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370945|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370946|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370947|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370948|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370949|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370950|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370951|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370952|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370953|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370954|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370955|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370956|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370957|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370958|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370959|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370960|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370961|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370962|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370963|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370964|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370965|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370966|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370967|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370968|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370969|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370970|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370971|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370972|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370973|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370974|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370975|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370976|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370977|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370978|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370979|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370980|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370981|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370982|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370983|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370984|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370985|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370986|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370987|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370988|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370989|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370990|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370991|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370992|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370993|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370994|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370995|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370996|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370997|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370998|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
370999|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371000|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371001|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371002|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371003|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371004|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371005|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371006|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371007|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371008|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371009|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371010|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371011|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371012|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371013|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371014|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371015|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371016|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371017|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371018|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371019|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371020|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371021|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371022|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371023|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371024|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371025|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371026|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371027|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371028|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371029|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371030|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371031|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371032|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371033|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371034|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371035|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371036|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371037|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371038|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371039|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371040|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371041|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371042|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371043|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371044|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371045|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371046|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371047|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible Participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371048|NCT01066819|E1|Reported Event|Total (PEG-IFN Alfa-2a +PEG-IFN Alfa-2b)|Eligible participants with serologically proven CHC who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
371049|NCT01066793|B7|Baseline|Total|Total of all reporting groups
371050|NCT01066793|B6|Baseline|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371051|NCT01066793|B5|Baseline|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371052|NCT01066793|B4|Baseline|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371053|NCT01066793|B3|Baseline|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371054|NCT01066793|B2|Baseline|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371055|NCT01066793|B1|Baseline|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371056|NCT01066793|P6|Participant Flow|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371057|NCT01066793|P5|Participant Flow|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371058|NCT01066793|P4|Participant Flow|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371059|NCT01066793|P3|Participant Flow|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371060|NCT01066793|P2|Participant Flow|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371328|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
371061|NCT01066793|P1|Participant Flow|Genotype 1 (G1)|Eligible participants infected with hepatitis C virus (HCV) of Genotype 1 who received Pegasys® (Pegylated Interferon [PEG-IFN] alfa-2a) or PegIntron® (PEG-IFN alfa-2b) plus ribavirin dose according to the standard of care and in line with summary of product characteristics (SPCs)/local labeling for up to 72 weeks were observed.
371062|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371063|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371064|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371065|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371066|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371067|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371068|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371069|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371070|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371071|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371072|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371073|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371074|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371075|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371076|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371077|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371078|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371079|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV inclusive of all Genotypes who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371080|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371081|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371082|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371083|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371084|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371085|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371086|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371087|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371088|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371089|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371090|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371091|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371092|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371093|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371094|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371095|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371096|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371097|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371098|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371099|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371100|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371101|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371102|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371103|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371104|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371105|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371106|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371107|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371108|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371109|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371110|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371111|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371112|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371451|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
371113|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371114|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371115|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371116|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371117|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371118|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371119|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371120|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371121|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371122|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371123|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371124|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371125|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371126|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371127|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371128|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371129|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371130|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371131|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371132|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371133|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371134|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371135|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371136|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371137|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371138|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
373615|NCT01059760|O1|Outcome|Baseline Value|
371139|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371140|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371141|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371142|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371143|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371144|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371145|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371146|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371147|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371148|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371149|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371150|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371151|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371152|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371153|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371154|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371155|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371156|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371157|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371158|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371159|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371160|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371161|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371162|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371163|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371164|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
373616|NCT01059760|O3|Outcome|Change When Fed|
371165|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371166|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371167|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371168|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371169|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371170|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371171|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371172|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371173|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371174|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371175|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371176|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371177|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371178|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371179|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371180|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371181|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371182|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371183|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371184|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371185|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371186|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371187|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371188|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371189|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371190|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
373617|NCT01059760|O2|Outcome|Change While Fasting|
371191|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371192|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371193|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371194|NCT01066793|E6|Reported Event|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371195|NCT01066793|E5|Reported Event|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371196|NCT01066793|E4|Reported Event|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371197|NCT01066793|E3|Reported Event|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371198|NCT01066793|E2|Reported Event|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371199|NCT01066793|E1|Reported Event|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
371200|NCT01066780|B1|Baseline|ClearVoice|
371201|NCT01066780|P2|Participant Flow|Group B: Received ClearVoice HIGH Followed by MEDIUM|Two week of chronic use of Clearvoice HIGH followed by two week of chronic use of ClearVoice MEDIUM.
371202|NCT01066780|P1|Participant Flow|Group A: Received ClearVoice MEDIUM Followed by HIGH|Two weeks of chronic use of ClearVoice MEDIUM followed by two week of chronic use of ClearVoice HIGH.
371203|NCT01066780|O1|Outcome|Group 1|Primary efficacy analyses were based on data from the 46 subjects that completed the study.
371204|NCT01066780|E1|Reported Event|Group 1|Primary efficacy analyses were based on data from the 46 subjects that completed the study.
371205|NCT01066624|B4|Baseline|Total|Total of all reporting groups
371206|NCT01066624|B3|Baseline|Calcium Phosphate (Caphosol) Mouth Rinse|"Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.~Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse: Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study."
371207|NCT01066624|B2|Baseline|Cryotherapy (Ice Chips)|Cryotherapy (ice chips): Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion. After patients are done with the cryotherapy they will follow the standard of care for prevention and management of oral mucositis until the end of the study.
371208|NCT01066624|B1|Baseline|0.9% Sodium Chloride Irrigation Solution|"Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study.~0.9% Sodium Chloride irrigation solution: Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study"
371209|NCT01066624|P3|Participant Flow|Calcium Phosphate (Caphosol) Mouth Rinse|"Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.~Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse: Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study."
371210|NCT01066624|P2|Participant Flow|Cryotherapy (Ice Chips)|Cryotherapy (ice chips): Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion. After patients are done with the cryotherapy they will follow the standard of care for prevention and management of oral mucositis until the end of the study.
371211|NCT01066624|P1|Participant Flow|0.9% Sodium Chloride Irrigation Solution|"Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study.~0.9% Sodium Chloride irrigation solution: Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study"
371212|NCT01066624|O3|Outcome|Calcium Phosphate (Caphosol) Mouth Rinse|"Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.~Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse: Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study."
371241|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
371213|NCT01066624|O2|Outcome|Cryotherapy (Ice Chips)|Cryotherapy (ice chips): Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion. After patients are done with the cryotherapy they will follow the standard of care for prevention and management of oral mucositis until the end of the study.
371214|NCT01066624|O1|Outcome|0.9% Sodium Chloride Irrigation Solution|"Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study.~0.9% Sodium Chloride irrigation solution: Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study"
371215|NCT01066624|E3|Reported Event|Calcium Phosphate (Caphosol) Mouth Rinse|"Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.~Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse: Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study."
371216|NCT01066624|E2|Reported Event|Cryotherapy (Ice Chips)|Cryotherapy (ice chips): Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion. After patients are done with the cryotherapy they will follow the standard of care for prevention and management of oral mucositis until the end of the study.
371217|NCT01066624|E1|Reported Event|0.9% Sodium Chloride Irrigation Solution|"Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study.~0.9% Sodium Chloride irrigation solution: Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study"
371218|NCT01066585|B3|Baseline|Total|Total of all reporting groups
371219|NCT01066585|B2|Baseline|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
371220|NCT01066585|B1|Baseline|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
371221|NCT01066585|P2|Participant Flow|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
371222|NCT01066585|P1|Participant Flow|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
371223|NCT01066585|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
371224|NCT01066585|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
371225|NCT01066585|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
371226|NCT01066585|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
371227|NCT01066585|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
371228|NCT01066585|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
371229|NCT01066585|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
371230|NCT01066585|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
371231|NCT01066585|E2|Reported Event|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
371232|NCT01066585|E1|Reported Event|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
371233|NCT01066546|B1|Baseline|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
371234|NCT01066546|P1|Participant Flow|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
371235|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
371236|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
371237|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
371238|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
371239|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
371240|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
371242|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
371243|NCT01066546|E1|Reported Event|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
371244|NCT01066520|B4|Baseline|Total|Total of all reporting groups
371245|NCT01066520|B3|Baseline|Diclofenac Gel|Diclofenac Gel 2g, 3 times daily topical during 14 days
371246|NCT01066520|B2|Baseline|Traumeel S Gel|Traumeel S Gel 2g, 3 times daily topical during 14 days
371247|NCT01066520|B1|Baseline|Traumeel S Ointment|Traumeel S Ointment 2g, 3 times daily topical during 14 days
371248|NCT01066520|P3|Participant Flow|Diclofenac Gel|NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
371249|NCT01066520|P2|Participant Flow|Traumeel S Gel|Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
371250|NCT01066520|P1|Participant Flow|Traumeel S Ointment|Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
371251|NCT01066520|O3|Outcome|Diclofenac Gel|NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
371252|NCT01066520|O2|Outcome|Traumeel S Gel|Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
371253|NCT01066520|O1|Outcome|Traumeel S Ointment|Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
371254|NCT01066520|O3|Outcome|Diclofenac Gel|NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
371255|NCT01066520|O2|Outcome|Traumeel S Gel|Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
371256|NCT01066520|O1|Outcome|Traumeel S Ointment|Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
371257|NCT01066520|O3|Outcome|Diclofenac Gel|NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
371258|NCT01066520|O2|Outcome|Traumeel S Gel|Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
371259|NCT01066520|O1|Outcome|Traumeel S Ointment|Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
371260|NCT01066520|E3|Reported Event|Diclofenac Gel|NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
371261|NCT01066520|E2|Reported Event|Traumeel S Gel|Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
371262|NCT01066520|E1|Reported Event|Traumeel S Ointment|Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
371263|NCT01066156|B1|Baseline|Seroquel|"This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD~Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD"
371264|NCT01066156|P1|Participant Flow|Seroquel|"This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD~Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD"
371265|NCT01066156|O1|Outcome|Seroquel|"This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD~Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD"
371266|NCT01066156|E1|Reported Event|Seroquel|"This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD~Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD"
371267|NCT01066143|B1|Baseline|Seroquel XR|Seroquel XR: Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.
371268|NCT01066143|P1|Participant Flow|Seroquel XR|Seroquel XR: Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.
371269|NCT01066143|O1|Outcome|Seroquel XR|Seroquel XR: Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.
371270|NCT01066143|E1|Reported Event|Seroquel XR|Seroquel XR: Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.
371271|NCT01066104|B3|Baseline|Total|Total of all reporting groups
371272|NCT01066104|B2|Baseline|Xolair (Omalizumab)|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
371273|NCT01066104|B1|Baseline|Xolair Placebo|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
371274|NCT01066104|P2|Participant Flow|Xolair (Omalizumab)|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
371275|NCT01066104|P1|Participant Flow|Xolair Placebo|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
371276|NCT01066104|O2|Outcome|Xolair (Omalizumab)|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
371277|NCT01066104|O1|Outcome|Xolair Placebo|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
371278|NCT01066104|O2|Outcome|Xolair (Omalizumab)|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
371279|NCT01066104|O1|Outcome|Xolair Placebo|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
371282|NCT01066039|B1|Baseline|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
371283|NCT01066039|P1|Participant Flow|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 milligram (mg) once daily for 24 weeks. If the blood pressure was not less than 130/80 millimeter of mercury (mmHg) during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
371284|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
371285|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
371286|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
371287|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
371288|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
371289|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
371290|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
371291|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
371292|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
371293|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
371294|NCT01066039|E1|Reported Event|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
371295|NCT01066000|B1|Baseline|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
371296|NCT01066000|P1|Participant Flow|Mircera|Eligible participants received methoxy polyethylene glycol-epoetin beta (Mircera) intravenously (IV), once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 microgram (mcg) which was based on the Epoetin dose of<8000, 8000-16000, or >16000 International units [IU]/Week, administered during the week preceding the switch to the study drug.
371297|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
371298|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
371299|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
371300|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
371301|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
373618|NCT01059760|O1|Outcome|Baseline Value|
371302|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
371303|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
371304|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
371305|NCT01066000|E1|Reported Event|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
371306|NCT01065844|B1|Baseline|Nelfinavir|"1250 mg Nelfinavir twice daily Monday-Sunday~Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday"
371307|NCT01065844|P1|Participant Flow|Nelfinavir|"1250 mg Nelfinavir twice daily Monday-Sunday~Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday"
371308|NCT01065844|O1|Outcome|Nelfinavir|"1250 mg Nelfinavir twice daily Monday-Sunday~Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday"
371309|NCT01065844|E1|Reported Event|Nelfinavir|"1250 mg Nelfinavir twice daily Monday-Sunday~Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday"
371310|NCT01065818|B1|Baseline|Fluoro-L-Thymidine|"Injection pre-Neoadjuvant Therapy (CRT, CT, or RT) and post-3 weeks Neoadjuvant Therapy (CRT, CT, RT)(3 weeks from the start of Neoadjuvant Therapy) prior to surgery.~Fluoro-L-Thymidine: 4D-PET/CT imaging with an injection of Fluoro-L-Thymidine at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy prior to surgery.~Data on age (per age categories) and race/ethnicity was not available for these 6 subjects. Only sex was available."
371311|NCT01065818|P1|Participant Flow|Fluoro-L-Thymidine|"Injection pre-Neoadjuvant Therapy (CRT, CT, or RT) and post-3 weeks Neoadjuvant Therapy (CRT, CT, RT)(3 weeks from the start of Neoadjuvant Therapy) prior to surgery.~Fluoro-L-Thymidine (FLT): 4-dimensional (4D)-Positron Emission Tomography (PET)/CT imaging with an injection of Fluoro-L-Thymidine at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy prior to surgery."
371312|NCT01065818|O1|Outcome|Fluoro-L-Thymidine|"Injection pre-Neoadjuvant Therapy (CRT, CT, or RT) and post-3 weeks Neoadjuvant Therapy (CRT, CT, RT)(3 weeks from the start of Neoadjuvant Therapy) prior to surgery.~Fluoro-L-Thymidine: 4D-PET/CT imaging with an injection of Fluoro-L-Thymidine at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy prior to surgery."
371313|NCT01065818|E1|Reported Event|Fluoro-L-Thymidine|"Injection pre-Neoadjuvant Therapy (CRT, CT, or RT) and post-3 weeks Neoadjuvant Therapy (CRT, CT, RT)(3 weeks from the start of Neoadjuvant Therapy) prior to surgery.~Fluoro-L-Thymidine: 4D-PET/CT imaging with an injection of Fluoro-L-Thymidine at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy prior to surgery.~Only 5 subjects were followed for AEs/SAEs since one subject withdrew consent prior to any participation in the study."
371314|NCT01065779|B1|Baseline|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
371315|NCT01065779|P1|Participant Flow|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
371316|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
371317|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
371318|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
371319|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
371320|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
371321|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
371322|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
371323|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
371324|NCT01065779|E1|Reported Event|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
371325|NCT01065766|B1|Baseline|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
371326|NCT01065766|P1|Participant Flow|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
371327|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
371329|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
371330|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
371331|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
371332|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
371333|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
371334|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
371335|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
371336|NCT01065766|E1|Reported Event|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
371337|NCT01065714|B1|Baseline|Hydrogel Vehicle/Eucerin Lotion|Parallel designed study. Split body treatment
371338|NCT01065714|P1|Participant Flow|Hydrogel Vehicle/Eucerin Lotion|Parallel designed study. Split body treatment. Eucerin Lotion applied to one side of body, Hydrogel applied to the opposite side of body.
371339|NCT01065714|O1|Outcome|Skin Hydration With Hydrogel|Parallel designed study. Split body treatment. Hydrogel vehicle applied to targeted area one side of body. Skin Hydration measured by 5 Corneometer readings.
371340|NCT01065714|O1|Outcome|Skin Hydration With Eucerin|Parallel designed study. Split body treatment. Five corneometer readings were taken on the targeted area of one half of the body on which Eucerin Lotion was applied.
371341|NCT01065714|O1|Outcome|Skin Barrier Function With Hydrogel Vehicle|Trans epidural water loss measurements on target areas of body side treated with Hydrogel vehicle
371342|NCT01065714|O1|Outcome|Skin Barrier Function With Eucerin Lotion|Measurement of TEWL on targeted area on one side of body treated with Eucerin Lotion
371343|NCT01065714|E1|Reported Event|Hydrogel Vehicle/Eucerin Lotion|Parallel designed study. Split body treatment
371344|NCT01065597|B1|Baseline|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy~Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
371345|NCT01065597|P1|Participant Flow|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy~Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
371346|NCT01065597|O1|Outcome|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy~Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
371347|NCT01065597|O1|Outcome|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy~Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
371348|NCT01065597|O1|Outcome|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy~Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
371349|NCT01065597|O1|Outcome|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy~Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
371350|NCT01065597|E1|Reported Event|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy~Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
371351|NCT01065558|B1|Baseline|Ecopipam|
371352|NCT01065558|P1|Participant Flow|Ecopipam (12.5- 200 mg/Day)|"Patients were given ecopipapm over an 11 day period as follows:~day 1 12.5 mg/day day 2-3 25 mg/day day 4-5 50 mg/day day 6-9 100 mg/day day 9-11 200 mg/day~Note: Doses were reduced as necessary to a previously tolerated dose if paitents reached doses that were not safely tolerable."
371353|NCT01065558|O1|Outcome|Ecopipam Treated Patients|These were patients who had diagnoses Lesch-Nyhan Disease based either on their genetic changes or on changes of specific enzymes in their blood.
371354|NCT01065558|O1|Outcome|Ecopipam Treated Patients|These were patients who had diagnoses Lesch-Nyhan Disease based either on their genetic changes or on changes of specific enzymes in their blood.
371355|NCT01065558|E1|Reported Event|Ecopipam Treated Patients|
371356|NCT01065506|B3|Baseline|Total|Total of all reporting groups
371357|NCT01065506|B2|Baseline|Standard Care Plus Exercise Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Aerobic Exercise: Aerobic Exercise"
373619|NCT01059760|O3|Outcome|Change When Fed|
371358|NCT01065506|B1|Baseline|Standard Care Plus Wellness Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Wellness Program: Wellness Program"
371359|NCT01065506|P2|Participant Flow|Standard Care Plus Exercise Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Aerobic Exercise: Aerobic Exercise thrice weekly (on a treadmill)"
371360|NCT01065506|P1|Participant Flow|Standard Care Plus Wellness Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Wellness Program: Wellness Program consisting of thrice weekly sessions involving discussion of various wellness topics (e.g., diet, sun care, cancer prevention) and generating small wellness-related goals"
371361|NCT01065506|O2|Outcome|Standard Care Plus Exercise Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Aerobic Exercise: Aerobic Exercise"
371362|NCT01065506|O1|Outcome|Standard Care Plus Wellness Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Wellness Program: Wellness Program"
371363|NCT01065506|E2|Reported Event|Standard Care Plus Exercise Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Aerobic Exercise: Aerobic Exercise"
371364|NCT01065506|E1|Reported Event|Standard Care Plus Wellness Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Wellness Program: Wellness Program"
371365|NCT01065480|B3|Baseline|Total|Total of all reporting groups
371366|NCT01065480|B2|Baseline|Taped Review Supervision|Clinicians from participating substance treatment programs audio record session with client and receive supervision after the session by MI trainer.
371367|NCT01065480|B1|Baseline|Live Teleconference Supervision|Clinicians from participating substance abuse treatment programs receive live supervision by MI trainer via teleconference while in session with client.
371368|NCT01065480|P2|Participant Flow|Taped Review Supervision|Clinicians from participating substance treatment programs audio record session with client and receive supervision after the session by MI trainer.
371369|NCT01065480|P1|Participant Flow|Live Teleconference Supervision|Clinicians from participating substance abuse treatment programs receive live supervision by MI trainer via teleconference while in session with client.
371370|NCT01065480|O2|Outcome|Taped Review Supervision|Clinicians from participating substance treatment programs audio record session with client and receive supervision after the session by MI trainer.
371371|NCT01065480|O1|Outcome|Live Teleconference Supervision|Clinicians from participating substance abuse treatment programs receive live supervision by MI trainer via teleconference while in session with client.
371372|NCT01065480|E2|Reported Event|Taped Review Supervision|Clinicians from participating substance treatment programs audio record session with client and receive supervision after the session by MI trainer.
371373|NCT01065480|E1|Reported Event|Live Teleconference Supervision|Clinicians from participating substance abuse treatment programs receive live supervision by MI trainer via teleconference while in session with client.
371374|NCT01065454|B5|Baseline|Total|Total of all reporting groups
371375|NCT01065454|B4|Baseline|Placebo|Participants received placebo tid.
371376|NCT01065454|B3|Baseline|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371377|NCT01065454|B2|Baseline|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371378|NCT01065454|B1|Baseline|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371379|NCT01065454|P4|Participant Flow|Placebo|Participants received placebo tid.
371380|NCT01065454|P3|Participant Flow|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371381|NCT01065454|P2|Participant Flow|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371382|NCT01065454|P1|Participant Flow|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371383|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
371384|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371385|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371386|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371387|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
371388|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371389|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371390|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371391|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
371392|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371393|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371394|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371395|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
371396|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371397|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371398|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371399|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
371400|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371401|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371402|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371403|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
371404|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371405|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371406|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371407|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
371408|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371409|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371410|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371411|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
371412|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371413|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371414|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371415|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
371416|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371417|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371418|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371419|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
371420|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371421|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371422|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371423|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
371424|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371425|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371426|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371427|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
371428|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371429|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371430|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371431|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
371432|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371433|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371434|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371435|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
371436|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371437|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371438|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371439|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
371440|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371441|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371442|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371443|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
371444|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371445|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371446|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371447|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
371448|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371449|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371450|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371452|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371453|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371454|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371455|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
371456|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371457|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371458|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371459|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
371460|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371461|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371462|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371463|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
371464|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371465|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371466|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371467|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
371468|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371469|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371470|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371471|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
371472|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371473|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371474|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371475|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
371476|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371477|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371478|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371479|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
371480|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371481|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371482|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371483|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
371484|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
371485|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
371486|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371487|NCT01065454|E4|Reported Event|Placebo|Participants received placebo tid
371488|NCT01065454|E3|Reported Event|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose)
371489|NCT01065454|E2|Reported Event|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg)
371490|NCT01065454|E1|Reported Event|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
371491|NCT01065428|B3|Baseline|Total|Total of all reporting groups
371492|NCT01065428|B2|Baseline|Weaning Successful|Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
371493|NCT01065428|B1|Baseline|Weaning Failure|Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
371494|NCT01065428|P2|Participant Flow|Weaning Successful|Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
371495|NCT01065428|P1|Participant Flow|Weaning Failure|Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
371496|NCT01065428|O2|Outcome|Weaning Successful|Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
371497|NCT01065428|O1|Outcome|Weaning Failure|Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
371498|NCT01065428|O2|Outcome|Weaning Successful|Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
373620|NCT01059760|O2|Outcome|Change While Fasting|
371499|NCT01065428|O1|Outcome|Weaning Failure|Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
371500|NCT01065428|E2|Reported Event|Weaning Successful|Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
371501|NCT01065428|E1|Reported Event|Weaning Failure|Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
371502|NCT01065350|B3|Baseline|Total|Total of all reporting groups
371503|NCT01065350|B2|Baseline|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose. One subject in the ketofol group was excluded from analysis due to incorrect study drug assignment and outside the protocol-specified dose."
371504|NCT01065350|B1|Baseline|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
371505|NCT01065350|P2|Participant Flow|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
371506|NCT01065350|P1|Participant Flow|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
371507|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
371508|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
371509|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
371510|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
371511|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
371512|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
371513|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
371514|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
371515|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
371516|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
371517|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
371518|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
371519|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
371520|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
371521|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
371522|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
371561|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
371523|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
371524|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
371525|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
371526|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
371527|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
371528|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
371529|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
371530|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
371531|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
371532|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
371533|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
371534|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
371535|NCT01065350|E2|Reported Event|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
371536|NCT01065350|E1|Reported Event|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
371537|NCT01065051|B3|Baseline|Total|Total of all reporting groups
371538|NCT01065051|B2|Baseline|Placebo|Participants received a single oral dose of 1 mg placebo.
371539|NCT01065051|B1|Baseline|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
371540|NCT01065051|P2|Participant Flow|Placebo|Participants received a single oral dose of 1 mg placebo.
371541|NCT01065051|P1|Participant Flow|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
371542|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
371543|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
371544|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
371545|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
371546|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
371547|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
371548|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
371549|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
371550|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
371551|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
371552|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
371553|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
371554|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
371555|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
371556|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
371557|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
371558|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
371559|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
371560|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
371563|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
371564|NCT01065051|E2|Reported Event|Placebo|Participants received a single oral dose of 1 mg placebo.
371565|NCT01065051|E1|Reported Event|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
371566|NCT01064947|B1|Baseline|All Participants|All consented subjects with a suspected secondary infection of atopic dermatitis were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if desired) for 7 days. The subject treatment site was cultured after 7 days of treatment.
371567|NCT01064947|P1|Participant Flow|All Participants|All consented subjects with an apparent secondary infection were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if desired) for 7 days. The subject treatment site was cultured after 7 days of treatment.
371568|NCT01064947|O1|Outcome|All Participants|All consented subjects with a suspected secondary infection of atopic dermatitis were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if desired) for 7 days. The subject treatment site was cultured after 7 days of treatment.
371569|NCT01064947|O1|Outcome|Participants With a Positive Culture at Day 1|
371570|NCT01064947|O1|Outcome|Participants With Positive Culture at Day 1|
371571|NCT01064947|O2|Outcome|Participants With a Positive Culture at Day 1|
371572|NCT01064947|O1|Outcome|All Participants at Day 1|All consented subjects with an apparent secondary infection were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if necessary) for 7 days. The subject treatment site was cultured after 7 days of treatment.
371573|NCT01064947|E1|Reported Event|All Participants|All consented subjects with a suspected secondary infection of atopic dermatitis were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if desired) for 7 days. The subject treatment site was cultured after 7 days of treatment.
371574|NCT01064882|B4|Baseline|Total|Total of all reporting groups
371575|NCT01064882|B3|Baseline|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
371576|NCT01064882|B2|Baseline|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
371577|NCT01064882|B1|Baseline|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
371578|NCT01064882|P3|Participant Flow|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
371579|NCT01064882|P2|Participant Flow|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
371580|NCT01064882|P1|Participant Flow|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
371581|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
371582|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
371583|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
371584|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
371585|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
371586|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
371587|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
371588|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
371589|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
371590|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
371591|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
371592|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
371593|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
371594|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
371595|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
371596|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
371597|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
371598|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
371599|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
371600|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
371601|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
371602|NCT01064882|E3|Reported Event|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
371603|NCT01064882|E2|Reported Event|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
371604|NCT01064882|E1|Reported Event|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
371605|NCT01064856|B3|Baseline|Total|Total of all reporting groups
371606|NCT01064856|B2|Baseline|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
371607|NCT01064856|B1|Baseline|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
371608|NCT01064856|P4|Participant Flow|Double-blind Placebo / Open-label Adalimumab|Placebo SC injection every other week (eow) up to Week 12 in the double-blind period; adalimumab 40 mg subcutaneous injection eow from Week 12 to Week 156 in the open-label period.
371609|NCT01064856|P3|Participant Flow|Double-blind Adalimumab / Open-label Adalimumab|Adalimumab 40 mg SC injection eow up to Week 12 in double-blind period and from Week 12 to Week 156 in open-label period.
373621|NCT01059760|O1|Outcome|Baseline Value|
371610|NCT01064856|P2|Participant Flow|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
371611|NCT01064856|P1|Participant Flow|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
371612|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
371613|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
371614|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
371615|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
371616|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
371617|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
371618|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
371619|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
371620|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
371621|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
371622|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
371623|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
371624|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
371625|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
371626|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
371627|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
371628|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
371629|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
371630|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
371631|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
371632|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
371633|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
371634|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
371635|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
371636|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
371637|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
371638|NCT01064856|E3|Reported Event|Any Adalimumab|All randomized participants who had received at least 1 dose of adalimumab (blinded or open-label) at any time during the study (up to Week 156).
371639|NCT01064856|E2|Reported Event|Double-blind Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
371640|NCT01064856|E1|Reported Event|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
371641|NCT01064830|B3|Baseline|Total|Total of all reporting groups
371642|NCT01064830|B2|Baseline|Vehicle|apply to affected nails at night
371643|NCT01064830|B1|Baseline|Cyclosporine Solution|apply to affected nails at night
371644|NCT01064830|P2|Participant Flow|Vehicle (Refresh Dry Eye Therapy®)|Topical vehicle: Refresh Dry Eye Therapy® (ophthalmic solution of glycerin 1% and polysorbate 80 1%)
371645|NCT01064830|P1|Participant Flow|Cyclosporine Solution 0.05% (Restasis®)|Topical Cyclosporine 0.05% Ophthalmic Suspension
371646|NCT01064830|O2|Outcome|Vehicle|vehicle
371647|NCT01064830|O1|Outcome|Cyclosporine Solution|cyclosporine solution
371648|NCT01064830|O2|Outcome|Vehicle|topical
371649|NCT01064830|O1|Outcome|Cyclosporine Solution|topical
371650|NCT01064830|E2|Reported Event|Vehicle|topical
371651|NCT01064830|E1|Reported Event|Cyclosporine Solution|topical
371652|NCT01064817|B3|Baseline|Total|Total of all reporting groups
371653|NCT01064817|B2|Baseline|Placebo|"Placebo~Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
371654|NCT01064817|B1|Baseline|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)~PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
371655|NCT01064817|P2|Participant Flow|Placebo|"Placebo~Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
371763|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
371656|NCT01064817|P1|Participant Flow|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)~PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
371657|NCT01064817|O2|Outcome|Placebo|"Placebo~Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
371658|NCT01064817|O1|Outcome|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)~PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
371659|NCT01064817|O2|Outcome|Placebo|"Placebo~Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
371660|NCT01064817|O1|Outcome|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)~PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
371661|NCT01064817|O2|Outcome|Placebo|"Placebo~Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
371662|NCT01064817|O1|Outcome|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)~PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
371663|NCT01064817|O2|Outcome|Placebo|"Placebo~Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
371664|NCT01064817|O1|Outcome|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)~PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
371665|NCT01064817|E2|Reported Event|Placebo|"Placebo~Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
371666|NCT01064817|E1|Reported Event|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)~PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
371667|NCT01064739|B1|Baseline|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371668|NCT01064739|P1|Participant Flow|Fixed Sodium Diet +/- Fava Beans|Participants consumed a fixed sodium diet on day 1 and the same diet plus 100g of fresh fava beans at breakfast and lunch on day 2.The 14 participants received both interventions.
371669|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371670|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
371671|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371672|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
371673|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|A study diet with a fixed amount of sodium and no fava beans.
371674|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371675|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
371676|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371677|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371678|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
372268|NCT01063595|E2|Reported Event|Octaplas SD|Participants received 1200 mL of Octaplas SD intravenously once.
371679|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371680|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
371681|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|A study diet with a fixed amount of sodium and no fava beans.
371682|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371683|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371684|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
371685|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|A study diet with a fixed amount of sodium and no fava beans.
371686|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371687|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371688|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
371689|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371690|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
371691|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371692|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
371693|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371694|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
371695|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371696|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
372269|NCT01063595|E1|Reported Event|Octaplas LG|Participants received 1200 mL of Octaplas LG intravenously once.
372270|NCT01063517|B3|Baseline|Total|Total of all reporting groups
371697|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371698|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
371699|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
371700|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371701|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
371702|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371703|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371704|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
371705|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371706|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
371707|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371708|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
371709|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371710|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
371711|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
371712|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371736|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
372728|NCT01061723|O3|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
371713|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
371714|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371715|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371716|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
371717|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371718|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
371719|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|A study diet with a fixed amount of sodium and no fava beans.
371720|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371721|NCT01064739|E2|Reported Event|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
371722|NCT01064739|E1|Reported Event|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
371723|NCT01064687|B5|Baseline|Total|Total of all reporting groups
371724|NCT01064687|B4|Baseline|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
371725|NCT01064687|B3|Baseline|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371726|NCT01064687|B2|Baseline|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371727|NCT01064687|B1|Baseline|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371728|NCT01064687|P4|Participant Flow|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
371729|NCT01064687|P3|Participant Flow|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371730|NCT01064687|P2|Participant Flow|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371731|NCT01064687|P1|Participant Flow|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371732|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371733|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371734|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
371735|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371737|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371738|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371739|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371740|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371741|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
371742|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371743|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371744|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371745|NCT01064687|O5|Outcome|Placebo/0.75 mg LY2189265|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): 0.75 milligrams (mg), SC, once weekly from week 26 through week 52~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371746|NCT01064687|O4|Outcome|Placebo/1.5 mg LY2189265|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): 1.5 milligrams (mg), SC, once weekly from week 26 through week 52~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371747|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371748|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371749|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371750|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
371751|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371752|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371753|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371754|NCT01064687|O3|Outcome|Placebo/0.75 mg LY2189265 or 1.5 mg LY2189265|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): 0.75 or 1.5 milligrams (mg), SC, once weekly from week 26 through week 52~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371755|NCT01064687|O2|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371756|NCT01064687|O1|Outcome|0.75 mg LY2189265 or 1.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 or 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371757|NCT01064687|O3|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
371758|NCT01064687|O2|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371759|NCT01064687|O1|Outcome|0.75 mg LY2189265 or 1.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 or 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371760|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371761|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371762|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
373622|NCT01059760|O3|Outcome|Change When Fed|
371764|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371765|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371766|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371767|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371768|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371769|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371770|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
371771|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371772|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371773|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371774|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371775|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371776|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371777|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
371778|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371779|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371780|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371781|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371782|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371783|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371784|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
371785|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371786|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371787|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371788|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371789|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371790|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371791|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
371792|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371793|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371794|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371795|NCT01064687|O5|Outcome|Placebo/0.75 mg LY2189265|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): 0.75 milligrams (mg), SC, once weekly from week 26 through week 52~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371796|NCT01064687|O4|Outcome|Placebo/1.5 mg LY2189265|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): 1.5 milligrams (mg), SC, once weekly from week 26 through week 52~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371797|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371798|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371799|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371800|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
371801|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371802|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371803|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371804|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371805|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371806|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371807|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
371808|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371809|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371810|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371811|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371812|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371813|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371814|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
371815|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371816|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371817|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371818|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371819|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371820|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371821|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
371822|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371823|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371824|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371825|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371826|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371827|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371828|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371829|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371830|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371831|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
371832|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371833|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371834|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371835|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371836|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371837|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371838|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
371839|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371840|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371841|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371842|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371843|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371844|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371845|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
371846|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371847|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371848|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371849|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371850|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371851|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371852|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
371853|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371854|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371855|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371856|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371857|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371858|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371859|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
371860|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371861|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371862|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371863|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371864|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371865|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371866|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
371867|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371868|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371869|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371870|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371871|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
373623|NCT01059760|O2|Outcome|Change While Fasting|
371872|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371873|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
371874|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371875|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371876|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371877|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371878|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371879|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371880|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
371881|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371882|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371883|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371884|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371885|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371886|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371887|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
371888|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371889|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371890|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371891|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371892|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371893|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371894|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
371895|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371896|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371897|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371920|NCT01064622|O2|Outcome|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
371898|NCT01064687|E9|Reported Event|Placebo/1.5 mg LY2189265 (26 Weeks Through 56 Weeks)|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): 1.5 milligrams (mg), SC, once weekly from week 26 through week 52~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks~All events were treatment emergent during the LY2189265 treatment period."
371899|NCT01064687|E8|Reported Event|Placebo/0.75 mg LY2189265 (26 Weeks Through 56 Weeks)|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): 0.75 milligrams (mg), SC, once weekly from week 26 through week 52~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks~All events were treatment emergent during the LY2189265 treatment period."
371900|NCT01064687|E7|Reported Event|Exenatide (Baseline Through 56 Weeks)|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371901|NCT01064687|E6|Reported Event|1.5 mg LY2189265 (Baseline Through 56 Weeks)|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371902|NCT01064687|E5|Reported Event|0.75 mg LY2189265 (Baseline Through 56 Weeks)|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371903|NCT01064687|E4|Reported Event|Placebo (Baseline Through 26 Weeks)|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): After 26 weeks, participants were randomized to receive either 0.75 milligrams (mg) or 1.5 mg, SC, once weekly for an additional 26 weeks (from week 26 through week 52)~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371904|NCT01064687|E3|Reported Event|Exenatide (Baseline Through 26 Weeks)|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371905|NCT01064687|E2|Reported Event|1.5 mg LY2189265 (Baseline Through 26 Weeks)|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371906|NCT01064687|E1|Reported Event|0.75 mg LY2189265 (Baseline Through 26 Weeks)|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
371907|NCT01064622|B4|Baseline|Total|Total of all reporting groups
371908|NCT01064622|B3|Baseline|Phase I lead-in Patients|Patients enrolled in the lead-in phase I portion of the trial. Patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and 150 mg vismodegib PO QD on days 1-28.
371909|NCT01064622|B2|Baseline|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
371910|NCT01064622|B1|Baseline|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
371911|NCT01064622|P2|Participant Flow|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
371912|NCT01064622|P1|Participant Flow|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
371913|NCT01064622|O3|Outcome|Phase I lead-in Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
371914|NCT01064622|O2|Outcome|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
371915|NCT01064622|O1|Outcome|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
371916|NCT01064622|O3|Outcome|Phase I lead-in Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
371917|NCT01064622|O2|Outcome|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
371918|NCT01064622|O1|Outcome|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
371919|NCT01064622|O3|Outcome|Phase I lead-in Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
371956|NCT01064401|B1|Baseline|Interferon Beta-1a|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
371921|NCT01064622|O1|Outcome|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
371922|NCT01064622|O3|Outcome|Phase I lead-in Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
371923|NCT01064622|O2|Outcome|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
371924|NCT01064622|O1|Outcome|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
371925|NCT01064622|O3|Outcome|Phase I lead-in Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
371926|NCT01064622|O2|Outcome|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
371927|NCT01064622|O1|Outcome|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
371928|NCT01064622|E4|Reported Event|Phase II Crossover Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
371929|NCT01064622|E3|Reported Event|Phase I lead-in Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
371930|NCT01064622|E2|Reported Event|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
371931|NCT01064622|E1|Reported Event|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
371932|NCT01064414|B4|Baseline|Total|Total of all reporting groups
371933|NCT01064414|B3|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks.
371934|NCT01064414|B2|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks.
371935|NCT01064414|B1|Baseline|Placebo|Each patient received matching placebo once daily for 52 weeks.
371936|NCT01064414|P3|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks.Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).
371937|NCT01064414|P2|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).
371938|NCT01064414|P1|Participant Flow|Placebo|Each patient received matching placebo once daily for 52 weeks. Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).
371939|NCT01064414|O3|Outcome|Canagliflozin 300 mg|Each patient received canagliflozin 300 mg once daily for 52 weeks.
371940|NCT01064414|O2|Outcome|Canagliflozin 100 mg|Each patient received canagliflozin 100 mg once daily for 52 weeks.
371941|NCT01064414|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks.
371942|NCT01064414|O3|Outcome|Canagliflozin 300 mg|Each patient received canagliflozin 300 mg once daily for 52 weeks.
371943|NCT01064414|O2|Outcome|Canagliflozin 100 mg|Each patient received canagliflozin 100 mg once daily for 52 weeks.
371944|NCT01064414|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks.
371945|NCT01064414|O3|Outcome|Canagliflozin 300 mg|Each patient received canagliflozin 300 mg once daily for 52 weeks.
371946|NCT01064414|O2|Outcome|Canagliflozin 100 mg|Each patient received canagliflozin 100 mg once daily for 52 weeks.
371947|NCT01064414|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks.
371948|NCT01064414|E6|Reported Event|Canagliflozin 300 mg: Baseline to Week 52|Each patient received 300 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 52.
371949|NCT01064414|E5|Reported Event|Canagliflozin 100 mg: Baseline to Week 52|Each patient received 100 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 52.
371950|NCT01064414|E4|Reported Event|Placebo: Baseline to Week 52|Each patient received matching placebo once daily for 52 weeks. Data are presented for Baseline to Week 52.
371951|NCT01064414|E3|Reported Event|Canagliflozin 300 mg: Baseline to Week 26|Each patient received 300 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 26.
371952|NCT01064414|E2|Reported Event|Canagliflozin 100 mg: Baseline to Week 26|Each patient received 100 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 26.
371953|NCT01064414|E1|Reported Event|Placebo: Baseline to Week 26|Each patient received matching placebo once daily for 52 weeks. Data are presented for Baseline to Week 26.
371954|NCT01064401|B3|Baseline|Total|Total of all reporting groups
371955|NCT01064401|B2|Baseline|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
373624|NCT01059760|O1|Outcome|Baseline Value|
371957|NCT01064401|P2|Participant Flow|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a intramuscular IM injection once weekly for 96 to 144 weeks
371958|NCT01064401|P1|Participant Flow|Interferon Beta-1a|Interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly plus placebo to daclizumab high yield process (DAC HYP) subcutaneous (SC) once every 4 weeks for 96 to 144 weeks
371959|NCT01064401|O2|Outcome|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
371960|NCT01064401|O1|Outcome|Interferon Beta-1a|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
371961|NCT01064401|O2|Outcome|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
371962|NCT01064401|O1|Outcome|Interferon Beta-1a|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
371963|NCT01064401|O2|Outcome|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
371964|NCT01064401|O1|Outcome|Interferon Beta-1a|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
371965|NCT01064401|O2|Outcome|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
371966|NCT01064401|O1|Outcome|Interferon Beta-1a|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
371967|NCT01064401|O2|Outcome|Daclizumab High Yield Process|DAC HYP 150 mg subcutaneous (SC) injection once every 4 weeks plus placebo to IFN β-1a intramuscular (IM) injection once weekly for 96 to 144 weeks
371968|NCT01064401|O1|Outcome|Interferon Beta-1a|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
371969|NCT01064401|E2|Reported Event|DAC HYP 150 mg|DAC HYP 150 mg subcutaneous (SC) injection once every 4 weeks plus placebo to IFN β-1a intramuscular (IM) injection once weekly for 96 to 144 weeks
371970|NCT01064401|E1|Reported Event|IFN Beta-1a 30 mcg|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
371971|NCT01064362|B3|Baseline|Total|Total of all reporting groups
371972|NCT01064362|B2|Baseline|Low Molecular Weight Heparins (LMWHs)|All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
371973|NCT01064362|B1|Baseline|Fondaparinux|All dosages of fondaparinux
371974|NCT01064362|P2|Participant Flow|Low Molecular Weight Heparins (LMWHs)|All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
371975|NCT01064362|P1|Participant Flow|Fondaparinux|All dosages of fondaparinux
371976|NCT01064362|O2|Outcome|Low Molecular Weight Heparins (LMWHs)|All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
371977|NCT01064362|O1|Outcome|Fondaparinux|All dosages of fondaparinux
371978|NCT01064362|O2|Outcome|Low Molecular Weight Heparins (LMWHs)|All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
371979|NCT01064362|O1|Outcome|Fondaparinux|All dosages of fondaparinux
371980|NCT01064362|E2|Reported Event|Low Molecular Weight Heparins (LMWHs)|All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
371981|NCT01064362|E1|Reported Event|Fondaparinux|All dosages of fondaparinux
371982|NCT01064323|B1|Baseline|Intermittent Leg Compression|"Intermittent leg compression daily for 3 hrs a day for 4 weeks~Intermittent pneumatic compression of the lower extremities: IPC will be done for 3 divided hours daily for 4 weeks"
371983|NCT01064323|P1|Participant Flow|Intermittent Leg Compression|Intermittent leg compression for one hour.
371984|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
371985|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
371986|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
371987|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
371988|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
371989|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
371990|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
371991|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
371992|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
371993|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
371994|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
371995|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
371996|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
371997|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
371998|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
371999|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
372000|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
372001|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
372002|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
372003|NCT01064323|E1|Reported Event|Intermittent Leg Compression|Intermittent leg compression for one hour.
372004|NCT01064310|B3|Baseline|Total|Total of all reporting groups
372081|NCT01064297|E3|Reported Event|Lamotrigine Polytherapy Without Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy without valproate exposures with completed pregnancy outcome (does not include those lost to follow up where outcome information could not be obtained)
372729|NCT01061723|O2|Outcome|Sarilumab 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
372005|NCT01064310|B2|Baseline|Pazopanib 800 mg Followed by Sunitinib 50 mg|Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
372006|NCT01064310|B1|Baseline|Sunitinib 50 mg Followed by Pazopanib 800 mg|Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
372007|NCT01064310|P3|Participant Flow|Open Label Pazopinib|To provide continued access to treatment
372008|NCT01064310|P2|Participant Flow|Pazopanib 800 mg Followed by Sunitinib 50 mg|Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
372009|NCT01064310|P1|Participant Flow|Sunitinib 50 mg Followed by Pazopanib 800 mg|Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
372010|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
372011|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
372012|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
372013|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
372014|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
372015|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
372016|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
372017|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
372018|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
372019|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
372020|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
372021|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
372022|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
372023|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
372024|NCT01064310|O2|Outcome|Pazopanib 800 mg Followed by Sunitinib 50 mg|Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
372025|NCT01064310|O1|Outcome|Sunitinib 50 mg Followed by Pazopanib 800 mg|Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
372026|NCT01064310|O2|Outcome|Pazopanib 800 mg Followed by Sunitinib 50 mg|Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
372027|NCT01064310|O1|Outcome|Sunitinib 50 mg Followed by Pazopanib 800 mg|Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
372028|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
372029|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
372030|NCT01064310|O2|Outcome|Pazopanib 800 mg Followed by Sunitinib 50 mg|Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
372122|NCT01064076|E1|Reported Event|S-ICD System|This is a single arm study
372730|NCT01061723|O1|Outcome|Placebo|Placebo (for sarilumab) qw for 12 weeks.
372031|NCT01064310|O1|Outcome|Sunitinib 50 mg Followed by Pazopanib 800 mg|Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
372032|NCT01064310|E3|Reported Event|Open Label Pazopanib|Open Label Pazopanib
372033|NCT01064310|E2|Reported Event|Pazopanib|Pazopanib
372034|NCT01064310|E1|Reported Event|Sunitinib|Sunitinib
372035|NCT01064297|B4|Baseline|Total|Total of all reporting groups
372036|NCT01064297|B3|Baseline|Lamotrigine Polytherapy Without Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy without valproate, all dose ranges
372037|NCT01064297|B2|Baseline|Lamotrigine Polytherapy With Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy with valproate, all dose ranges
372038|NCT01064297|B1|Baseline|Lamotrigine Monotherapy Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine monotherapy at doses between 0-1200 mg/day
372039|NCT01064297|P3|Participant Flow|Lamotrigine Polytherapy Without Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy without valproate, all dose ranges
372040|NCT01064297|P2|Participant Flow|Lamotrigine Polytherapy With Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy with valproate, all dose ranges
372041|NCT01064297|P1|Participant Flow|Lamotrigine Monotherapy Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine monotherapy at doses between 0-1200 mg/day
372042|NCT01064297|O4|Outcome|Unknown Maximal Dose in Exposed Trimester|
372043|NCT01064297|O3|Outcome|Doses Higher Than Prescribed|>400 mg/day maximal dose in first trimester
372044|NCT01064297|O2|Outcome|Prescribed Doses|201-400 mg/day maximal dose in first trimester
372045|NCT01064297|O1|Outcome|Doses Lower Than Prescribed|>0 to 200 mg/day maximal dose in first trimester
372046|NCT01064297|O4|Outcome|Unknown Maximal Dose in Exposed Trimester|
372047|NCT01064297|O3|Outcome|Doses Higher Than Prescribed|>400 mg/day maximal dose in first trimester
372048|NCT01064297|O2|Outcome|Prescribed Doses|201-400 mg/day maximal dose in first trimester
372049|NCT01064297|O1|Outcome|Doses Lower Than Prescribed|>0 to 200 mg/day maximal dose in first trimester
372050|NCT01064297|O4|Outcome|Unknown Maximal Dose in Exposed Trimester|
372051|NCT01064297|O3|Outcome|Dose Higher Than Prescribed|>400 mg/day maximal dose in first trimester
372052|NCT01064297|O2|Outcome|Prescribed Doses|201-400 mg/day maximal dose in first trimester
372053|NCT01064297|O1|Outcome|Doses Lower Than Prescribed|>0 to 200 mg/day maximal dose in first trimester
372054|NCT01064297|O5|Outcome|All Trimesters|Exposure during any trimester of pregnancy
372055|NCT01064297|O4|Outcome|Unspecified Trimester of Exposure|The earliest trimester of exposure was not specified
372056|NCT01064297|O3|Outcome|First Exposure During Third Trimester|The third trimester begins at 28 weeks gestation
372057|NCT01064297|O2|Outcome|First Exposure During Second Trimester|The second trimester begins at 14 weeks gestation
372058|NCT01064297|O1|Outcome|First Exposure During First Trimester|The first trimester begins at conception
372059|NCT01064297|O5|Outcome|All Trimesters|Exposure during any trimester of pregnancy
372060|NCT01064297|O4|Outcome|Unspecified Trimester of Exposure|The earliest trimester of exposure was not specified
372061|NCT01064297|O3|Outcome|First Exposure During Third Trimester|The third trimester begins at 28 weeks gestation
372062|NCT01064297|O2|Outcome|First Exposure During Second Trimester|The second trimester begins at 14 weeks gestation
372063|NCT01064297|O1|Outcome|First Exposure During First Trimester|The first trimester begins at conception
372064|NCT01064297|O5|Outcome|All Trimesters|Exposure during any trimester of pregnancy
372065|NCT01064297|O4|Outcome|Unspecified Trimester of Exposure|The earliest trimester of exposure was not specified
372066|NCT01064297|O3|Outcome|First Exposure During Third Trimester|The third trimester begins at 28 weeks gestation
372067|NCT01064297|O2|Outcome|First Exposure During Second Trimester|The second trimester begins at 14 weeks gestation
372068|NCT01064297|O1|Outcome|First Exposure During First Trimester|The first trimester begins at conception
372069|NCT01064297|O4|Outcome|Unspecified Trimester of Exposure|The earliest trimester of exposure was not specified
372070|NCT01064297|O3|Outcome|First Exposure During Third Trimester|The third trimester begins at 28 weeks gestation
372071|NCT01064297|O2|Outcome|First Exposure During Second Trimester|The second trimester begins at 14 weeks gestation
372072|NCT01064297|O1|Outcome|First Exposure During First Trimester|The first trimester begins at conception
372073|NCT01064297|O4|Outcome|Unspecified Trimester of Exposure|The earliest trimester of exposure was not specified
372074|NCT01064297|O3|Outcome|First Exposure During Third Trimester|The third trimester begins at 28 weeks gestation
372075|NCT01064297|O2|Outcome|First Exposure During Second Trimester|The second trimester begins at 14 weeks gestation
372076|NCT01064297|O1|Outcome|First Exposure During First Trimester|The first trimester begins at conception
372077|NCT01064297|O4|Outcome|Unspecified Trimester of Exposure|The earliest trimester of exposure was not specified
372078|NCT01064297|O3|Outcome|First Exposure During Third Trimester|The third trimester begins at 28 weeks gestation
372079|NCT01064297|O2|Outcome|First Exposure During Second Trimester|The second trimester begins at 14 weeks gestation
372080|NCT01064297|O1|Outcome|First Exposure During First Trimester|The first trimester begins at conception
372174|NCT01063881|O1|Outcome|Dapoxetine (Baseline)|Baseline measures were taken before administration of treatment.
372731|NCT01061723|O6|Outcome|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
372082|NCT01064297|E2|Reported Event|Lamotrigine Polytherapy With Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy with valproate exposures with completed pregnancy outcome (does not include those lost to follow up where outcome information could not be obtained)
372083|NCT01064297|E1|Reported Event|Lamotrigine Monotherapy Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine monotherapy with completed pregnancy outcome (does not include those lost to follow up where outcome information could not be obtained)
372084|NCT01064284|B3|Baseline|Total|Total of all reporting groups
372085|NCT01064284|B2|Baseline|rFVIII|"Recombinant FVIII~Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
372086|NCT01064284|B1|Baseline|pd vWF/FVIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
372087|NCT01064284|P2|Participant Flow|rFVIII|"Recombinant FVIII~Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
372088|NCT01064284|P1|Participant Flow|pd vWF/FVIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
372089|NCT01064284|O2|Outcome|rFVIII|"Recombinant FVIII~Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
372090|NCT01064284|O1|Outcome|pd vWF/FVIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
372091|NCT01064284|O2|Outcome|rFVIII|"Recombinant FVIII~Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
372092|NCT01064284|O1|Outcome|pd vWF/FVIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
372093|NCT01064284|O2|Outcome|rFVIII|"Recombinant FVIII~Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
372094|NCT01064284|O1|Outcome|pd vWF/FVIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
372095|NCT01064284|O2|Outcome|rFVIII|"Recombinant FVIII~Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
372096|NCT01064284|O1|Outcome|pd vWF/FVIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
372097|NCT01064284|O2|Outcome|rFVIII|"Recombinant FVIII~Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
372098|NCT01064284|O1|Outcome|pd vWF/FVIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
372099|NCT01064284|O2|Outcome|rFVIII|"Recombinant FVIII~Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
372100|NCT01064284|O1|Outcome|pd vWF/FVIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
372101|NCT01064284|O2|Outcome|rFVIII|"Recombinant FVIII~Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
372102|NCT01064284|O1|Outcome|PLASMA DERIVED Factor VIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
372103|NCT01064284|O2|Outcome|rFVIII|"Recombinant FVIII~Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
372104|NCT01064284|O1|Outcome|pd vWF/FVIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
372105|NCT01064284|E2|Reported Event|rFVIII|"Recombinant FVIII~Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
372106|NCT01064284|E1|Reported Event|pd vWF/FVIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
372107|NCT01064167|B3|Baseline|Total|Total of all reporting groups
372108|NCT01064167|B2|Baseline|Control Group|The placebo consisted of an equivalent volume of saline solution.
372109|NCT01064167|B1|Baseline|Tranexamic Acid Group|Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
372110|NCT01064167|P2|Participant Flow|Control Group|The placebo consisted of an equivalent volume of saline solution.
372111|NCT01064167|P1|Participant Flow|Tranexamic Acid Group|Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
372112|NCT01064167|O2|Outcome|Control Group|The placebo consisted of an equivalent volume of saline solution.
372113|NCT01064167|O1|Outcome|Tranexamic Acid Group|Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
372114|NCT01064167|O2|Outcome|Control Group|The placebo consisted of an equivalent volume of saline solution.
372115|NCT01064167|O1|Outcome|Tranexamic Acid Group|Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
372116|NCT01064167|E2|Reported Event|Control Group|The placebo consisted of an equivalent volume of saline solution.
372117|NCT01064167|E1|Reported Event|Tranexamic Acid Group|Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
372118|NCT01064076|B1|Baseline|S-ICD System|This is a single arm study
372119|NCT01064076|P1|Participant Flow|S-ICD System|This is a single arm study
372120|NCT01064076|O1|Outcome|S-ICD System|This is a single arm study
372121|NCT01064076|O1|Outcome|Single Arm|Cohort includes all subjects undergoing an implant attempt
372123|NCT01063907|B1|Baseline|KW-2478 and Bortezomib|"The target population in both Phase 1 and 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1–3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.~For Phase 1, the design was a standard 3+3 study of KW-2478 (130 or 175 mg/m^2) and Bortezomib(1.0 or 1.3 mg/m^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts (overall N=15). The Phase 2 portion of the study enrolled 80 subjects to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m^2 / Bortezomib 1.3 mg/m^2)."
372124|NCT01063907|P2|Participant Flow|Phase II: KW-2478 130mg/m^2 and Bortezomib 1.3mg/m^2|"The target population in Phase 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1–3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.~For the Phase 2 portion of the study was designed to determine the preliminary efficacy of KW 2478 and bortezomib at the RP2D (KW-2478 175 mg/m^2/bortezomib1.3 mg/m^2)."
372125|NCT01063907|P1|Participant Flow|Phase 1: KW-2478 and Bortezomib|"The target population in Phase 1 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1–3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.~For Phase 1, the design was a standard 3+3 study of KW-2478 (130 or 175 mg/m^2) and bortezomib(1.0 or 1.3 mg/m^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts."
372126|NCT01063907|O4|Outcome|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
372127|NCT01063907|O3|Outcome|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
372128|NCT01063907|O2|Outcome|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
372129|NCT01063907|O1|Outcome|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
372130|NCT01063907|O4|Outcome|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
372131|NCT01063907|O3|Outcome|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
372132|NCT01063907|O2|Outcome|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
372133|NCT01063907|O1|Outcome|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
372134|NCT01063907|O4|Outcome|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
372135|NCT01063907|O3|Outcome|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
372136|NCT01063907|O2|Outcome|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
372137|NCT01063907|O1|Outcome|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
372138|NCT01063907|O4|Outcome|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
372139|NCT01063907|O3|Outcome|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
372140|NCT01063907|O2|Outcome|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
372141|NCT01063907|O1|Outcome|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
372142|NCT01063907|O6|Outcome|Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Phase 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m^2/Bortezomib 1.3 mg/m^2).
372143|NCT01063907|O5|Outcome|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
372144|NCT01063907|O4|Outcome|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
372145|NCT01063907|O3|Outcome|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
372146|NCT01063907|O2|Outcome|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
372147|NCT01063907|O1|Outcome|Phase 1 & 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|"The target population in both Phase 1 and 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1–3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.~The Phase 1 portion of the study was a standard 3+3 study design of KW-2478 (130 or 175 mg/m^2) and Bortezomib (1.0 or 1.3 mg/m^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts.~The Phase 2 portion of the study was designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m^2/Bortezomib 1.3 mg/m^2)."
373625|NCT01059760|O3|Outcome|Change When Fed|
372148|NCT01063907|E6|Reported Event|Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3 mg/m^2|Phase 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle designed to determine the preliminary efficacy of KW 2478 + BTZ at the RP2D (KW-2478 175 mg/m^2/BTZ 1.3 mg/m^2).
372149|NCT01063907|E5|Reported Event|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3 mg/m^2|Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
372150|NCT01063907|E4|Reported Event|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0 mg/m^2|Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
372151|NCT01063907|E3|Reported Event|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3 mg/m^2|Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
372152|NCT01063907|E2|Reported Event|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0 mg/m^2|Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
372153|NCT01063907|E1|Reported Event|Phase 1 and 2: KW-2478 and Bortezomib|KW-2478 and bortezomib: KW 2478 and bortezomib given on Days 1, 4, 8 and 11 of a 21 day cycle
372154|NCT01063881|B4|Baseline|Total|Total of all reporting groups
372155|NCT01063881|B3|Baseline|Dapoxetine 30 to 60 to 30 mg|13 patients took at least one dose of dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
372156|NCT01063881|B2|Baseline|Dapoxetine 30 to 60 mg|124 of 125 patients took at least one dose of dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
372157|NCT01063881|B1|Baseline|Dapoxetine 30 mg Only|144 of 147 patients took at least 1 dose of dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
372158|NCT01063881|P3|Participant Flow|Dapoxetine 30 to 60 to 30 mg|Patients who started on dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
372159|NCT01063881|P2|Participant Flow|Dapoxetine 30 to 60 mg|Patients who started on dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
372160|NCT01063881|P1|Participant Flow|Dapoxetine 30 mg Only|Patients who took dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
372161|NCT01063881|O2|Outcome|Dapoxetine (Patients With IELT >1 Minute, Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
372162|NCT01063881|O1|Outcome|Dapoxetine (Patients With IELT <1 Minute, Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
372163|NCT01063881|O2|Outcome|Dapoxetine (Patients With Acquired PE, Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
372164|NCT01063881|O1|Outcome|Dapoxetine (Patients With Life-long PE, Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
372165|NCT01063881|O3|Outcome|Dapoxetine 30 to 60 to 30 mg|Patients who started on dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
372166|NCT01063881|O2|Outcome|Dapoxetine 30 to 60 mg|Patients who started on dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
372167|NCT01063881|O1|Outcome|Dapoxetine 30 mg Only|Patients who took dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
372168|NCT01063881|O1|Outcome|Dapoxetine (Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
372169|NCT01063881|O2|Outcome|Dapoxetine (Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
372170|NCT01063881|O1|Outcome|Dapoxetine (Baseline)|Baseline measures were taken before administration of treatment.
372171|NCT01063881|O2|Outcome|Dapoxetine (Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
372172|NCT01063881|O1|Outcome|Dapoxetine (Baseline)|Baseline measures were taken before administration of treatment.
372173|NCT01063881|O2|Outcome|Dapoxetine (Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
372175|NCT01063881|O2|Outcome|Dapoxetine (Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
372176|NCT01063881|O1|Outcome|Dapoxetine (Baseline)|Baseline measures were taken before administration of treatment.
372177|NCT01063881|O1|Outcome|Dapoxetine (Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
372178|NCT01063881|E3|Reported Event|Depoxetine (DPX) 30 to 60 to 30 mg|Patients who started on dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
372179|NCT01063881|E2|Reported Event|Depoxetine (DPX) 30 to 60 mg|Patients who started on dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
372180|NCT01063881|E1|Reported Event|Depoxetine (DPX) 30 mg Only|Patients who took dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
372181|NCT01063868|B3|Baseline|Total|Total of all reporting groups
372182|NCT01063868|B2|Baseline|Oxycodone CR|Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
372183|NCT01063868|B1|Baseline|Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
372184|NCT01063868|P2|Participant Flow|Oxycodone CR|Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
372185|NCT01063868|P1|Participant Flow|Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
372186|NCT01063868|O2|Outcome|Oxycodone CR|Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
372187|NCT01063868|O1|Outcome|Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
372188|NCT01063868|E2|Reported Event|Oxycodone CR|Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
372189|NCT01063868|E1|Reported Event|Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
372190|NCT01063855|B3|Baseline|Total|Total of all reporting groups
372191|NCT01063855|B2|Baseline|PDE5I + DPX|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
372192|NCT01063855|B1|Baseline|PDE5I + PLACEBO|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
372193|NCT01063855|P2|Participant Flow|PDE5I + DPX|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
372194|NCT01063855|P1|Participant Flow|PDE5I + PLACEBO|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
372195|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
372196|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
372197|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
372198|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
372199|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
372200|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
372201|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
372202|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
372203|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
372259|NCT01063595|B1|Baseline|All Participants|Participants received 1200 mL of Octaplas LG intravenously once and 1200 mL of Octaplas SD intravenously once in a crossover design.
372204|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
372205|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
372206|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
372207|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
372208|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
372209|NCT01063855|O4|Outcome|PDE5I + Dapoxetine (Week 12)|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction
372210|NCT01063855|O3|Outcome|PDE5I + Dapoxetine (Baseline)|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction
372211|NCT01063855|O2|Outcome|PDE5I + Placebo (Week 12)|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
372212|NCT01063855|O1|Outcome|PDE5I + Placebo (Baseline)|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
372213|NCT01063855|E2|Reported Event|PDE5I + DPX|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
372214|NCT01063855|E1|Reported Event|PDE5I + PLACEBO|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
372215|NCT01063829|B5|Baseline|Total|Total of all reporting groups
372216|NCT01063829|B4|Baseline|Placebo|Placebo: Oral Administration
372217|NCT01063829|B3|Baseline|AIC246 (240 mg)|AIC246: Oral Administration
372218|NCT01063829|B2|Baseline|AIC246 (120 mg)|AIC246: Oral Administration
372219|NCT01063829|B1|Baseline|AIC246 (60 mg)|AIC246: Oral Administration
372220|NCT01063829|P4|Participant Flow|Placebo|Placebo: Oral Administration
372221|NCT01063829|P3|Participant Flow|AIC246 (240 mg)|AIC246: Oral Administration
372222|NCT01063829|P2|Participant Flow|AIC246 (120 mg)|AIC246: Oral Administration
372223|NCT01063829|P1|Participant Flow|AIC246 (60 mg)|AIC246: Oral Administration
372224|NCT01063829|O4|Outcome|Placebo|Placebo: Oral Administration
372225|NCT01063829|O3|Outcome|AIC246 (240 mg)|AIC246: Oral Administration
372226|NCT01063829|O2|Outcome|AIC246 (120 mg)|AIC246: Oral Administration
372227|NCT01063829|O1|Outcome|AIC246 (60 mg)|AIC246: Oral Administration
372228|NCT01063829|O4|Outcome|Placebo|Placebo: Oral Administration
372229|NCT01063829|O3|Outcome|AIC246 (240 mg)|AIC246: Oral Administration
372230|NCT01063829|O2|Outcome|AIC246 (120 mg)|AIC246: Oral Administration
372231|NCT01063829|O1|Outcome|AIC246 (60 mg)|AIC246: Oral Administration
372232|NCT01063829|O4|Outcome|Placebo|Placebo: Oral Administration
372233|NCT01063829|O3|Outcome|AIC246 (240 mg)|AIC246: Oral Administration
372234|NCT01063829|O2|Outcome|AIC246 (120 mg)|AIC246: Oral Administration
372235|NCT01063829|O1|Outcome|AIC246 (60 mg)|AIC246: Oral Administration
372236|NCT01063829|E4|Reported Event|Placebo|Placebo: Oral Administration
372237|NCT01063829|E3|Reported Event|AIC246 (240 mg)|AIC246: Oral Administration
372238|NCT01063829|E2|Reported Event|AIC246 (120 mg)|AIC246: Oral Administration
372239|NCT01063829|E1|Reported Event|AIC246 (60 mg)|AIC246: Oral Administration
372240|NCT01063764|B1|Baseline|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
372260|NCT01063595|P2|Participant Flow|Octaplas LG First, Then Octaplas SD|Participants received 1200 mL of Octaplas LG intravenously once. At least 4 weeks later, participants received 1200 mL of Octaplas SD intravenously once.
372261|NCT01063595|P1|Participant Flow|Octaplas SD First, Then Octaplas LG|Participants received 1200 mL of Octaplas SD intravenously once. At least 4 weeks later, participants received 1200 mL of Octaplas LG intravenously once.
372262|NCT01063595|O2|Outcome|Octaplas SD|Participants received 1200 mL of Octaplas SD intravenously once.
372263|NCT01063595|O1|Outcome|Octaplas LG|Participants received 1200 mL of Octaplas LG intravenously once.
372241|NCT01063764|P1|Participant Flow|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
372242|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
372243|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
372244|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
372245|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
372246|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
372247|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
372248|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
372249|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
372264|NCT01063595|O2|Outcome|Octaplas SD|Participants received 1200 mL of Octaplas SD intravenously once.
372265|NCT01063595|O1|Outcome|Octaplas LG|Participants received 1200 mL of Octaplas LG intravenously once.
372250|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
372251|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
372252|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
372253|NCT01063764|E1|Reported Event|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
372254|NCT01063712|B1|Baseline|"Effectiveness of the Device: Nit-Occlud® PDA-R"|"Children born with patent arterial duct develop cardiac insufficiency early in life, show failure to thrive and frequent respiratory infections. Pulmonary hyperflow through the duct can lead to changes in the pulmonary vasculature and irreversible pulmonary hypertension. This can be prevented if we close the ducts on time. The classical method is open thorax surgery, which involves deep anaesthesia, a scar, possible complications (thorax deformities and instability) and a long stay in hospital. With the Interventional Closure of Patent Arterial Duct technique the patients stay only one day in hospital, the thorax is not open, and only slight sedation is needed. The device closure and the surgery have similar closure rates, but there are fewer complications using the intervention method, and it is also less expensive.~This group of patients were chosen because they have duct in mean sizes (2-8 mm), haven´t developed pulmonary hypertension and have enough weight to be treated."
372255|NCT01063712|P1|Participant Flow|"Nit-Occlud® PDA-R Implantations Group"|"Children born with patent arterial duct develop cardiac insufficiency early in life, show failure to thrive and frequent respiratory infections. Pulmonary hyperflow through the duct can lead to changes in the pulmonary vasculature and irreversible pulmonary hypertension. This can be prevented if we close the ducts on time. The classical method is open thorax surgery, which involves deep anaesthesia, a scar, possible complications (thorax deformities and instability) and a long stay in hospital. With the Interventional Closure of Patent Arterial Duct technique the patients stay only one day in hospital, the thorax is not open, and only slight sedation is needed. The device closure and the surgery have similar closure rates, but there are fewer complications using the intervention method, and it is also less expensive.~This group of patients were chosen because they have ducts in mean sizes (2-8 mm), haven´t developed pulmonary hypertension and have enough weight to be treated."
372256|NCT01063712|O1|Outcome|Number of Patients With Complete Regression of Dilation|"Children born with patent arterial duct develop cardiac insufficiency early in life. Pulmonary hyperflow through the duct can lead to changes in the pulmonary vasculature and irreversible pulmonary hypertension. This can be prevented if we close the duct on time. The device closure and the surgery have similar closure rates, but there are fewer complications using the intervention method.~This group of patients had 2-8 mm ductus, haven´t developed pulmonary hypertension and have enough weight to be treated.~Patients with left to right shunt show a dilation of left ventricle and left atrium. The quotient Left atrium/aortic ring is a well known method to estimate the grade of the dilation of the left atrium. The M-Mode method, is useful to assessed the regression of the ventricle after the ducts is closed. These observations were made at the beginning of the study and after six months."
372257|NCT01063712|O1|Outcome|Closure in the Control Period|"The number of patients who showed no more duct bloodflow (seen with color doppler echocardiography or color flow) in the control period is given as number and as percentage of the complete group."
372258|NCT01063712|E1|Reported Event|"Effectiveness of the Device: Nit-Occlud® PDA-R"|"Children born with patent arterial duct develop cardiac insufficiency early in life, show failure to thrive and frequent respiratory infections. Pulmonary hyperflow through the duct can lead to changes in the pulmonary vasculature and irreversible pulmonary hypertension. This can be prevented if we close the ducts on time. The classical method is open thorax surgery, which involves deep anaesthesia, a scar, possible complications (thorax deformities and instability) and a long stay in hospital. With the Interventional Closure of Patent Arterial Duct technique the patients stay only one day in hospital, the thorax is not open, and only slight sedation is needed. The device closure and the surgery have similar closure rates, but there are fewer complications using the intervention method, and it is also less expensive.~This group of patients were chosen because they have duct in mean sizes (2-8 mm), haven´t developed pulmonary hypertension and have enough weight to be treated."
372271|NCT01063517|B2|Baseline|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
372272|NCT01063517|B1|Baseline|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
372273|NCT01063517|P2|Participant Flow|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
372274|NCT01063517|P1|Participant Flow|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
372275|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
372276|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
372277|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
372278|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
372279|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
372280|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
372281|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
372282|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
372283|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
372284|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
372285|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
372286|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
372287|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
372288|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
372289|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
372290|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
372291|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
372292|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
372293|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
372294|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
372295|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
372296|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
372297|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
372298|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
372299|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
372300|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
372301|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
372302|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
372303|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
372304|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
372305|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
372306|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
372307|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
372308|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
372309|NCT01063517|E2|Reported Event|PLACEBO 100MG BD + PACLITAXEL / PLACEBO 200MG BD|
372310|NCT01063517|E1|Reported Event|OLAPARIB 100MG BD + PACLITAXEL / OLAPARIB 200MG BD|
372311|NCT01063348|B3|Baseline|Total|Total of all reporting groups
372312|NCT01063348|B2|Baseline|Placebo|"Matching placebo taken daily~Placebo: Matching placebo capsules taken in same amount of pills as the active medication."
372313|NCT01063348|B1|Baseline|N-Acetyl Cysteine|"N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)~N-Acetyl Cysteine: Week 0 (Visit 1) – Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) – Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) – Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)"
372314|NCT01063348|P2|Participant Flow|Placebo|"Matching placebo taken daily~Placebo: Matching placebo capsules taken in same amount of pills as the active medication."
372315|NCT01063348|P1|Participant Flow|N-Acetyl Cysteine|"N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)~N-Acetyl Cysteine: Week 0 (Visit 1) – Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) – Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) – Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)"
373626|NCT01059760|O2|Outcome|Change While Fasting|
372316|NCT01063348|O2|Outcome|Placebo|"Matching placebo taken daily~Placebo: Matching placebo capsules taken in same amount of pills as the active medication."
372317|NCT01063348|O1|Outcome|N-Acetyl Cysteine|"N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)~N-Acetyl Cysteine: Week 0 (Visit 1) – Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) – Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) – Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)"
372318|NCT01063348|O2|Outcome|Placebo|"Matching placebo taken daily~Placebo: Matching placebo capsules taken in same amount of pills as the active medication."
372319|NCT01063348|O1|Outcome|N-Acetyl Cysteine|"N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)~N-Acetyl Cysteine: Week 0 (Visit 1) – Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) – Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) – Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)"
372320|NCT01063348|E2|Reported Event|Placebo|"Matching placebo taken daily~Placebo: Matching placebo capsules taken in same amount of pills as the active medication."
372321|NCT01063348|E1|Reported Event|N-Acetyl Cysteine|"N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)~N-Acetyl Cysteine: Week 0 (Visit 1) – Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) – Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) – Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)"
372322|NCT01063153|B3|Baseline|Total|Total of all reporting groups
372323|NCT01063153|B2|Baseline|ADHD|Subjects with ADHD
372324|NCT01063153|B1|Baseline|Control|Subjects without ADHD
372325|NCT01063153|P2|Participant Flow|ADHD|Subjects with ADHD were assessed with EEG before and after treatment with Concerta
372326|NCT01063153|P1|Participant Flow|Control|Controls without ADHD were assessed using EEG
372327|NCT01063153|O4|Outcome|Control Group and Visual Go Task|Participants without a DSM-IV diagnosis of ADHD completed the Go Visual Task, in which they had to perform a motor response to a stimulus.
372328|NCT01063153|O3|Outcome|ADHD and Visual Go Task|Participants with a DSM-IV diagnosis of ADHD completed the Go Visual Task, in which they had to perform a motor response to a stimulus.
372329|NCT01063153|O2|Outcome|Control Group and Visual NoGo Task|Participants without a DSM-IV diagnosis of ADHD completed the NoGo Visual Task, in which they had to refrain from responding.
372330|NCT01063153|O1|Outcome|ADHD and Visual NoGo Task|Participants with a DSM-IV diagnosis of ADHD completed the NoGo Visual Task, in which they had to refrain from responding.
372331|NCT01063153|O2|Outcome|Controls|Controls without ADHD were assessed with a one-time EEG, only.
372332|NCT01063153|O1|Outcome|ADHD|Subjects with ADHD were assessed before and after treatment.
372333|NCT01063153|E2|Reported Event|ADHD|Subjects with ADHD were assessed with EEG before and after open-label treatment with Concerta.
372334|NCT01063153|E1|Reported Event|Control|Subjects without ADHD were assessed using EEG.
372335|NCT01063075|B1|Baseline|All Participants (Group A, B, C and D)|"Group D:~Cycle 1:400 mg/m² cetuximab week (w) 1,day(d) 1.Carboplatin(AUC=5) on w 1, d 1.Optional 1000 mg/m²/d 5-FU given as a 96-hour C.I. starting(strt) on w 1, d 1.~Group C:~Cycle 1:Carboplatin(AUC=5) on w 1,d 1. 400 mg/m² cetuximab on w 2, d 1.Cetuximab 250 mg/m ² on w 3 and 4, d 1.~Cycle 2-6:Carboplatin(AUC=5) and 250 mg/m² cetuximab on w 1, d 1.1000 mg/m²/d 5-FU given as a 96-hour C.I. strt on w 1, d 1.250 mg/m² cetuximab on w 2 and 3, d 1.~Group B:~Cycle 1:400 mg/m² cetuximab on w 1, d 1. 250 mg/m ² cetuximab on w 2 and 3, d 1.~Cycle 2:Carboplatin(AUC=5) w 1, d 1.1000 mg/m ²/d 5-FU given as 96-hour C.I. strt on w 1, d 1. 250 mg/m ² cetuximab w 1- 3, d 1.~Group A:~Cycle 1:Carboplatin(AUC=5) on w 1, d 1. 1000 mg/m²/d 5-FU given as 96-hour C.I. strt on w 1, d 1.~400 mg/m² cetuximab on w 2, d 1 and 250 mg/m² cetuximab on w 3, d 1. Cycle 2:Carboplatin(AUC=5) given I.V on w 1, d 1.1000 mg/m²/d 5-FU given as 96-hour C.I. strt on w 1, d 1. 250 mg/m² cetuximab on w 1-3, d 1."
372336|NCT01063075|P4|Participant Flow|Cetuximab and Carboplatin (D)|"Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.~Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1."
372337|NCT01063075|P3|Participant Flow|Cetuximab and Carboplatin (C)|"Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
372338|NCT01063075|P2|Participant Flow|Cetuximab and Carboplatin (B)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1."
372339|NCT01063075|P1|Participant Flow|Carboplatin and Cetuximab (A)|"Group A:~Cycle 1 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 milligrams per square meter (mg/m ²) cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 1- 3, day 1."
372340|NCT01063075|O1|Outcome|Cetuximab (D)|"Group D:~Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.~Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1."
372351|NCT01063075|E3|Reported Event|Carboplatin and Cetuximab (C)|"Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
372341|NCT01063075|O2|Outcome|Cetuximab and Carboplatin (B and C)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.~Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
372342|NCT01063075|O1|Outcome|Cetuximab (B and C)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.~Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
372343|NCT01063075|O1|Outcome|Cetuximab and Carboplatin (D)|"Group D:~Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.~Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1."
372344|NCT01063075|O2|Outcome|Cetuximab and Carboplatin (B and C)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.~Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
372345|NCT01063075|O1|Outcome|Cetuximab (B and C)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.~Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
372346|NCT01063075|O1|Outcome|Cetuximab and Carboplatin (D)|"Group D:~Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.~Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1."
372347|NCT01063075|O2|Outcome|Cetuximab and Carboplatin (B and C)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.~Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
372348|NCT01063075|O1|Outcome|Cetuximab (B and C)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.~Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
372349|NCT01063075|O1|Outcome|Cetuximab and Carboplatin (D)|"Group D:~Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.~Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1."
372350|NCT01063075|E4|Reported Event|Carboplatin and Cetuximab (D)|"Group D:~Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on day 1. Carboplatin area under the curve (AUC=5) administered I.V on day 1.~Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on day 1."
372471|NCT01062425|B1|Baseline|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
372352|NCT01063075|E2|Reported Event|Carboplatin and Cetuximab (B)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1."
372353|NCT01063075|E1|Reported Event|Carboplatin and Cetuximab (A)|"Group A:~Cycle 1 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m ² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 1- 3, day 1."
372354|NCT01063062|B3|Baseline|Total|Total of all reporting groups
372355|NCT01063062|B2|Baseline|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
372356|NCT01063062|B1|Baseline|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
372357|NCT01063062|P2|Participant Flow|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
372358|NCT01063062|P1|Participant Flow|Tocilizumab|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
372359|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
372360|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
372361|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
372362|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
372363|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
372364|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
372365|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
372366|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
372367|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
372368|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
372369|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
372370|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
372371|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
372372|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
372373|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
372374|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
372375|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
372376|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
372377|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
372378|NCT01063062|O1|Outcome|Tocilizumab|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
372472|NCT01062425|P2|Participant Flow|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
372379|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
372380|NCT01063062|O1|Outcome|Tocilizumab|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
372381|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
372382|NCT01063062|O1|Outcome|Tocilizumab|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
372383|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
372384|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
372385|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
372386|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
372387|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
372388|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
372389|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
372390|NCT01063062|O1|Outcome|Tocilizumab|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
372391|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
372392|NCT01063062|O1|Outcome|Tocilizumab|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
372393|NCT01063062|E2|Reported Event|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
372394|NCT01063062|E1|Reported Event|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
372395|NCT01063049|B4|Baseline|Total|Total of all reporting groups
372396|NCT01063049|B3|Baseline|Gatorade/Miralax + Bisacodyl|Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
372397|NCT01063049|B2|Baseline|Gatorade/Miralax + Placebo|Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
372398|NCT01063049|B1|Baseline|Nulytely|Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
372399|NCT01063049|P3|Participant Flow|Gatorade/Miralax + Bisacodyl|Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
372400|NCT01063049|P2|Participant Flow|Gatorade/Miralax + Placebo|Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
372401|NCT01063049|P1|Participant Flow|Nulytely|Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
372402|NCT01063049|O3|Outcome|Gatorade/Miralax + Bisacodyl|Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
372403|NCT01063049|O2|Outcome|Gatorade/Miralax + Placebo|Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
372404|NCT01063049|O1|Outcome|Nulytely|Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
372405|NCT01063049|O3|Outcome|Gatorade/Miralax + Bisacodyl|Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
372406|NCT01063049|O2|Outcome|Gatorade/Miralax + Placebo|Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
372407|NCT01063049|O1|Outcome|Nulytely|Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
372507|NCT01062399|E5|Reported Event|Ph II: RT + TMZ + RAD001|Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
372408|NCT01063049|E3|Reported Event|Gatorade/Miralax + Bisacodyl|Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
372409|NCT01063049|E2|Reported Event|Gatorade/Miralax + Placebo|Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
372410|NCT01063049|E1|Reported Event|Nulytely|Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
372411|NCT01063036|B1|Baseline|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
372412|NCT01063036|P1|Participant Flow|Entecavir + Tenofovir|"Entecavir (ETV) : Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
372413|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
372414|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
372415|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
372416|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
372417|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
372418|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
372419|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
372420|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
372421|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
372422|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
372423|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
372424|NCT01063036|E1|Reported Event|Entecavir + Tenofovir|Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks
372425|NCT01062841|B3|Baseline|Total|Total of all reporting groups
372426|NCT01062841|B2|Baseline|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
372427|NCT01062841|B1|Baseline|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all nursing home residents with indwelling devices; active screening for MDRO (multidrug resistant organisms) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
372428|NCT01062841|P2|Participant Flow|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices. Surveillance cultures and data was collected for outcome comparison only.
372429|NCT01062841|P1|Participant Flow|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all nursing home residents with indwelling devices; active screening for MDRO (multidrug resistant organisms) monthly using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
372430|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
372431|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
372432|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
372508|NCT01062399|E4|Reported Event|Ph II: RT + TMZ|Radiation therapy and concurrent temozolomide followed by post-radiation temozolomide
372433|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
372434|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
372435|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
372436|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
372437|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
372438|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
372439|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
372440|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
372441|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
372442|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
372443|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
372444|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
372445|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
372446|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
372509|NCT01062399|E3|Reported Event|Ph I: RT + TMZ + RAD001 10 mg/Day|Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
372447|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
372448|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
372449|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
372450|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
372451|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
372452|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
372453|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
372454|NCT01062841|E2|Reported Event|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
372455|NCT01062841|E1|Reported Event|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
372456|NCT01062763|B3|Baseline|Total|Total of all reporting groups
372457|NCT01062763|B2|Baseline|Placebo|
372458|NCT01062763|B1|Baseline|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment~placebo : addition of placebo 1 to 2 tablets daily~spironolactone : 25 to 50 mg once daily"
372459|NCT01062763|P2|Participant Flow|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment~placebo : addition of placebo 1 to 2 tablets daily~spironolactone : 25 to 50 mg once daily"
372460|NCT01062763|P1|Participant Flow|Placebo|1tablet of matching placebo trated up to 2 if neccessary
372461|NCT01062763|O2|Outcome|Placebo|1tablet of matching placebo uptrated to 2 if neccessary
372462|NCT01062763|O1|Outcome|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment~spironolactone : 25 uptrated if necessary to 50 mg once daily"
372463|NCT01062763|O2|Outcome|Placebo|1tablet of matching placebo uptrated to 2 if neccessary
372464|NCT01062763|O1|Outcome|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment~spironolactone : 25 uptrated if necessary to 50 mg once daily"
372465|NCT01062763|O2|Outcome|Placebo|1tablet of matching placebo uptrated to 2 if neccessary
372466|NCT01062763|O1|Outcome|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment~spironolactone : 25 uptrated if necessary to 50 mg once daily"
372467|NCT01062763|E2|Reported Event|Placebo|1tablet of matching placebo uptrated to 2 if neccessary
372468|NCT01062763|E1|Reported Event|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment~spironolactone : 25 uptrated if necessary to 50 mg once daily"
372469|NCT01062425|B3|Baseline|Total|Total of all reporting groups
372470|NCT01062425|B2|Baseline|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
372634|NCT01061736|P5|Participant Flow|Part A: SAR 200 mg q2w|Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
372473|NCT01062425|P1|Participant Flow|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
372474|NCT01062425|O2|Outcome|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
372475|NCT01062425|O1|Outcome|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
372476|NCT01062425|O2|Outcome|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
372477|NCT01062425|O1|Outcome|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
372478|NCT01062425|O2|Outcome|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
372479|NCT01062425|O1|Outcome|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
372480|NCT01062425|O2|Outcome|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
372481|NCT01062425|O1|Outcome|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
372482|NCT01062425|E2|Reported Event|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
372483|NCT01062425|E1|Reported Event|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
372484|NCT01062399|B6|Baseline|Total|Total of all reporting groups
372485|NCT01062399|B5|Baseline|Ph II: RT + TMZ + RAD001|Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
372486|NCT01062399|B4|Baseline|Ph II: RT + TMZ|Radiation therapy and concurrent temozolomide followed by post-radiation temozolomide
372487|NCT01062399|B3|Baseline|Ph I: RT + TMZ + RAD001 10 mg/Day|Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
372488|NCT01062399|B2|Baseline|Ph I: RT + TMZ + RAD001 5 mg/Day|Radiation therapy, concurrent temozolomide, and concurrent RAD001 5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
372489|NCT01062399|B1|Baseline|Ph I: RT + TMZ + RAD001 2.5 mg/Day|Radiation therapy (RT), concurrent temozolomide (TMZ), and concurrent RAD001 2.5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
372490|NCT01062399|P5|Participant Flow|Ph II: RT + TMZ + RAD001|Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
372491|NCT01062399|P4|Participant Flow|Ph II: RT + TMZ|Radiation therapy and concurrent temozolomide followed by post-radiation temozolomide
372492|NCT01062399|P3|Participant Flow|Ph I: RT + TMZ + RAD001 10 mg/Day|Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
372493|NCT01062399|P2|Participant Flow|Ph I: RT + TMZ + RAD001 5 mg/Day|Radiation therapy, concurrent temozolomide, and concurrent RAD001 5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
372494|NCT01062399|P1|Participant Flow|Ph I: RT + TMZ + RAD001 2.5 mg/Day|Radiation therapy (RT), concurrent temozolomide (TMZ), and concurrent RAD001 2.5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
372495|NCT01062399|O2|Outcome|Ph II: RT + TMZ + RAD001|Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
372496|NCT01062399|O1|Outcome|Ph II: RT + TMZ|Radiation therapy and concurrent temozolomide followed by post-radiation temozolomide
372497|NCT01062399|O3|Outcome|Ph I: RT + TMZ + RAD001 10 mg/Day|Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
372498|NCT01062399|O2|Outcome|Ph I: RT + TMZ + RAD001 5 mg/Day|Radiation therapy, concurrent temozolomide, and concurrent RAD001 5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
372499|NCT01062399|O1|Outcome|Ph I: RT + TMZ + RAD001 2.5 mg/Day|Radiation therapy (RT), concurrent temozolomide (TMZ), and concurrent RAD001 2.5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
372500|NCT01062399|O2|Outcome|Ph II: RT + TMZ + RAD001|Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
372501|NCT01062399|O1|Outcome|Ph II: RT + TMZ|Radiation therapy and concurrent temozolomide followed by post-radiation temozolomide
372502|NCT01062399|O2|Outcome|Ph II: RT + TMZ + RAD001|Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
372503|NCT01062399|O1|Outcome|Ph II: RT + TMZ|Radiation therapy and concurrent temozolomide followed by post-radiation temozolomide
372504|NCT01062399|O3|Outcome|Ph I: RT + TMZ + RAD001 10 mg/Day|Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
372505|NCT01062399|O2|Outcome|Ph I: RT + TMZ + RAD001 5 mg/Day|Radiation therapy, concurrent temozolomide, and concurrent RAD001 5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
372506|NCT01062399|O1|Outcome|Ph I: RT + TMZ + RAD001 2.5 mg/Day|Radiation therapy (RT), concurrent temozolomide (TMZ), and concurrent RAD001 2.5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
372510|NCT01062399|E2|Reported Event|Ph I: RT + TMZ + RAD001 5 mg/Day|Radiation therapy, concurrent temozolomide, and concurrent RAD001 5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
372511|NCT01062399|E1|Reported Event|Ph I: RT + TMZ + RAD001 2.5 mg/Day|Radiation therapy (RT), concurrent temozolomide (TMZ), and concurrent RAD001 2.5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
372512|NCT01062308|B3|Baseline|Total|Total of all reporting groups
372513|NCT01062308|B2|Baseline|Sham Taping|Sham Taping was applied without stretching the concerned muscles.
372514|NCT01062308|B1|Baseline|Taping|Procedure for preventing shoulder injury
372515|NCT01062308|P2|Participant Flow|Sham Taping|Sham Taping was applied without stretching the concerned muscles.
372516|NCT01062308|P1|Participant Flow|Taping|Procedure for preventing shoulder injury
372517|NCT01062308|O2|Outcome|Sham Taping|Sham Taping was applied without stretching the concerned muscles.
372518|NCT01062308|O1|Outcome|Taping|Procedure for preventing shoulder injury
372519|NCT01062308|O2|Outcome|Sham Taping|Sham Taping was applied without stretching the concerned muscles.
372520|NCT01062308|O1|Outcome|Taping|Procedure for preventing shoulder injury
372521|NCT01062308|E2|Reported Event|Sham Taping|Sham Taping was applied without stretching the concerned muscles.
372522|NCT01062308|E1|Reported Event|Taping|Procedure for preventing shoulder injury
372523|NCT01062269|B1|Baseline|Cholestyramine 4 Grams vs 12 Grams vs Tang|Although 3 different arms are used in this study, there is only one study group. All subjects receive all 3 treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for all three arms.
372524|NCT01062269|P1|Participant Flow|Cholestyramine 4 Grams vs 12 Grams vs Tang|Although 3 different arms are used in this study, there is only one study group. All subjects receive all 3 treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for all three arms.
372525|NCT01062269|O3|Outcome|Tang|
372526|NCT01062269|O2|Outcome|Cholestyramine 12 Grams|
372527|NCT01062269|O1|Outcome|Cholestyramine 4 Grams|
372528|NCT01062269|O3|Outcome|Tang|
372529|NCT01062269|O2|Outcome|Cholestyramine 12 Grams|
372530|NCT01062269|O1|Outcome|Cholestyramine 4 Grams|
372531|NCT01062269|E3|Reported Event|Tang|
372532|NCT01062269|E2|Reported Event|Cholestyramine 12 Grams|
372533|NCT01062269|E1|Reported Event|Cholestyramine 4 Grams|
372534|NCT01062256|B4|Baseline|Total|Total of all reporting groups
372535|NCT01062256|B3|Baseline|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
372536|NCT01062256|B2|Baseline|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
372537|NCT01062256|B1|Baseline|Placebo|One placebo tablet administered orally as a single dose
372538|NCT01062256|P3|Participant Flow|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
372539|NCT01062256|P2|Participant Flow|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
372540|NCT01062256|P1|Participant Flow|Placebo|One placebo tablet administered orally as a single dose
372541|NCT01062256|O3|Outcome|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
372542|NCT01062256|O2|Outcome|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
372543|NCT01062256|O1|Outcome|Placebo|One placebo tablet administered orally as a single dose
372544|NCT01062256|O3|Outcome|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
372545|NCT01062256|O2|Outcome|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
372546|NCT01062256|O1|Outcome|Placebo|One placebo tablet administered orally as a single dose
372547|NCT01062256|O3|Outcome|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
372548|NCT01062256|O2|Outcome|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
372549|NCT01062256|O1|Outcome|Placebo|One placebo tablet administered orally as a single dose
372550|NCT01062256|O3|Outcome|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
372551|NCT01062256|O2|Outcome|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
372552|NCT01062256|O1|Outcome|Placebo|One placebo tablet administered orally as a single dose
372553|NCT01062256|O3|Outcome|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
372554|NCT01062256|O2|Outcome|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
372555|NCT01062256|O1|Outcome|Placebo|One placebo tablet administered orally as a single dose
372556|NCT01062256|O3|Outcome|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
372557|NCT01062256|O2|Outcome|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
372558|NCT01062256|O1|Outcome|Placebo|One placebo tablet administered orally as a single dose
372559|NCT01062256|E3|Reported Event|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
372560|NCT01062256|E2|Reported Event|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
372561|NCT01062256|E1|Reported Event|Placebo|One placebo tablet administered orally as a single dose
372562|NCT01062230|B1|Baseline|All Patients|"All participants enrolled.~Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.~Patients will undergo three 21-day cycles."
372563|NCT01062230|P1|Participant Flow|All Patients|"All participants enrolled.~Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.~Patients will undergo three 21-day cycles."
372564|NCT01062230|O1|Outcome|All Patients|"All participants enrolled.~Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.~Patients will undergo three 21-day cycles."
372565|NCT01062230|E1|Reported Event|All Patients|"All participants enrolled.~Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.~Patients will undergo three 21-day cycles."
372566|NCT01062165|B1|Baseline|Capsofungin|"Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.~Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)"
372567|NCT01062165|P1|Participant Flow|Capsofungin|"Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.~Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)"
372568|NCT01062165|O1|Outcome|Capsofungin|"Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.~Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)"
372569|NCT01062165|E1|Reported Event|Capsofungin|"Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.~Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)"
372570|NCT01062113|B4|Baseline|Total|Total of all reporting groups
372571|NCT01062113|B3|Baseline|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
372572|NCT01062113|B2|Baseline|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
372573|NCT01062113|B1|Baseline|Initial Dose Celecoxib 400 mg|Included the participants who received initial dose of celecoxib 400 mg only
372574|NCT01062113|P3|Participant Flow|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
372575|NCT01062113|P2|Participant Flow|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
372576|NCT01062113|P1|Participant Flow|Initial Dose Celecoxib 400 mg|Included the participants who received initial dose of celecoxib 400 mg only
372577|NCT01062113|O2|Outcome|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
372578|NCT01062113|O1|Outcome|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
372579|NCT01062113|O2|Outcome|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
372580|NCT01062113|O1|Outcome|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
372581|NCT01062113|O2|Outcome|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
372582|NCT01062113|O1|Outcome|Additional Dose Celecoxib 200mg|Included participants who received Celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
372583|NCT01062113|O2|Outcome|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
372584|NCT01062113|O1|Outcome|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
372585|NCT01062113|E3|Reported Event|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
372586|NCT01062113|E2|Reported Event|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
372587|NCT01062113|E1|Reported Event|Initial Dose Celecoxib 400 mg|Included the participants who received initial dose of celecoxib 400 mg only
372588|NCT01062074|B1|Baseline|Korean Participants|Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
372589|NCT01062074|P1|Participant Flow|Korean Participants|Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
372590|NCT01062074|O1|Outcome|Korean Participants|Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
372591|NCT01062074|O1|Outcome|Korean Participants|Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
372592|NCT01062074|E1|Reported Event|Korean Participants|Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
372593|NCT01062061|B1|Baseline|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
372594|NCT01062061|P1|Participant Flow|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
372595|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
372596|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
372597|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
372598|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
372599|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
372600|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
372601|NCT01062061|O2|Outcome|Age ≥2 Years|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
372602|NCT01062061|O1|Outcome|Age <2 Years|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
372603|NCT01062061|O2|Outcome|Female Participants|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
372604|NCT01062061|O1|Outcome|Male Participants|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
372605|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
372606|NCT01062061|E1|Reported Event|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
372607|NCT01061866|B1|Baseline|Thalidomide|Tablets thalidomide at 200 mg dosage 100 mg in the morning and 100 mg in the night was administered daily during a twelve month period.
372608|NCT01061866|P1|Participant Flow|Thalidomide|Thalidomide tablets 200 mg per day during twelve months was administrated to 7 males with 25 years old mean and refractory epilepsy, without modifying their previous treatment.
372609|NCT01061866|O1|Outcome|Thalidomide|Thalidomide tablets 200 mg per day during twelve months was administrated to 7 males with 25 years old mean and refractory epilepsy, without modifying their previous treatment.
372610|NCT01061866|E1|Reported Event|Thalidomide|Thalidomide tablets 200 mg per day during twelve months was administrated to 7 males with 25 years old mean and refractory epilepsy, without modifying their previous treatment.
372611|NCT01061775|B1|Baseline|Exenatide|Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
372612|NCT01061775|P1|Participant Flow|Exenatide|Participants received 5mcg of exenatide twice a day for 4 weeks and increased to 10 mcg twice a day for 20 weeks.
372613|NCT01061775|O1|Outcome|Exenatide|"Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.~Of 55 potential participants screened, 19 agreed to participate. Reasons for decline included reluctance to add another medication to their current regimens, travel distance, and aversion to an injectable medication. Sixteen patients completed the study. Of the three who failed to complete the study, one was lost to follow up, and two dropped out due to difficulty adhering to the twice daily injections, but none experienced significant side effects from therapy. Three of the 19 patients were on chronic metformin therapy."
372614|NCT01061775|O1|Outcome|Exenatide|Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
372615|NCT01061775|O1|Outcome|Exenatide|Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
372616|NCT01061775|O1|Outcome|Exenatide|Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
372617|NCT01061775|E1|Reported Event|Exenatide|Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
372618|NCT01061736|B11|Baseline|Total|Total of all reporting groups
372619|NCT01061736|B10|Baseline|Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)|Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
372620|NCT01061736|B9|Baseline|Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)|Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
372621|NCT01061736|B8|Baseline|Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2)|Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
372622|NCT01061736|B7|Baseline|Part B Cohort 1: Non-selected Doses|Sarilumab 100 mg qw, 150 mg qw or 100 mg q2w SC injections on top of MTX up to dose selection. After dose selection, participants were not continued but were allowed to participate in the open-label, long-term, extension study SARIL-RA-EXTEND (LTS11210).
372623|NCT01061736|B6|Baseline|Part A: Placebo qw|Placebo (for sarilumab) qw on top of MTX for 12 weeks.
372624|NCT01061736|B5|Baseline|Part A: SAR 200 mg q2w|Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
372625|NCT01061736|B4|Baseline|Part A: SAR 150 mg q2w|Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
372626|NCT01061736|B3|Baseline|Part A: SAR 100 mg q2w|Sarilumab 100 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
372627|NCT01061736|B2|Baseline|Part A: SAR 150 mg qw|Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.
372628|NCT01061736|B1|Baseline|Part A: SAR 100 mg qw|Sarilumab 100 mg SC injection qw on top of MTX for 12 weeks.
372629|NCT01061736|P10|Participant Flow|Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)|Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
372630|NCT01061736|P9|Participant Flow|Part B: SAR 200 mg q2w (Cohort 1 [Selected Dose]+Cohort 2)|Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
372631|NCT01061736|P8|Participant Flow|Part B: SAR 150 mg q2w (Cohort 1 [Selected Dose]+Cohort 2)|Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
372632|NCT01061736|P7|Participant Flow|Part B Cohort 1: Non-selected Doses|Sarilumab 100 mg qw, 150 mg qw or 100 mg q2w SC injections as in Part A on top of MTX up to dose selection. After dose selection, participants were not continued but were allowed to participate in the open-label, long-term, extension study SARIL-RA-EXTEND (LTS11210).
372633|NCT01061736|P6|Participant Flow|Part A: Placebo qw|Placebo (for sarilumab) qw on top of MTX for 12 weeks.
372635|NCT01061736|P4|Participant Flow|Part A: SAR 150 mg q2w|Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
372636|NCT01061736|P3|Participant Flow|Part A: SAR 100 mg q2w|Sarilumab 100 mg SC injection every other week (q2w) alternating with placebo on top of MTX for 12 weeks.
372637|NCT01061736|P2|Participant Flow|Part A: SAR 150 mg qw|Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.
372638|NCT01061736|P1|Participant Flow|Part A: SAR 100 mg qw|Sarilumab 100 mg subcutaneous (SC) injection weekly (qw) on top of methotrexate (MTX) for 12 weeks.
372639|NCT01061736|O3|Outcome|Part B: Placebo q2w|Participants randomized after dose selection received Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks.
372640|NCT01061736|O2|Outcome|Part B: SAR 200 mg q2w|Participants randomized after dose selection received Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
372641|NCT01061736|O1|Outcome|Part B: SAR 150 mg q2w|Participants randomized after dose selection received Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
372642|NCT01061736|O3|Outcome|Part B: Placebo q2w|Participants randomized after dose selection received Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks.
372643|NCT01061736|O2|Outcome|Part B: SAR 200 mg q2w|Participants randomized after dose selection received Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
372644|NCT01061736|O1|Outcome|Part B: SAR 150 mg q2w|Participants randomized after dose selection received Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
372645|NCT01061736|O3|Outcome|Part B: Placebo q2w|Participants randomized after dose selection received Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks.
372646|NCT01061736|O2|Outcome|Part B: SAR 200 mg q2w|Participants randomized after dose selection received Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
372647|NCT01061736|O1|Outcome|Part B: SAR 150 mg q2w|Participants randomized after dose selection received Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
372648|NCT01061736|O3|Outcome|Part B: Placebo q2w|Participants randomized after dose selection received Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks
372649|NCT01061736|O2|Outcome|Part B: SAR 200 mg q2w|Participants randomized after dose selection received Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
372650|NCT01061736|O1|Outcome|Part B: SAR 150 mg q2w|Participants randomized after dose selection received Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
372651|NCT01061736|O6|Outcome|Part A: Placebo qw|Placebo (for sarilumab) qw on top of MTX for 12 weeks.
372652|NCT01061736|O5|Outcome|Part A: SAR 200 mg q2w|Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
372653|NCT01061736|O4|Outcome|Part A: SAR 150 mg q2w|Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
372654|NCT01061736|O3|Outcome|Part A: SAR 100 mg q2w|Sarilumab 100 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
372655|NCT01061736|O2|Outcome|Part A: SAR 150 mg qw|Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.
372656|NCT01061736|O1|Outcome|Part A: SAR 100 mg qw|Sarilumab 100 mg SC injection qw on top of MTX for 12 weeks.
372657|NCT01061736|E13|Reported Event|Part B Sarilumab Rescue: Cohort 1(Selected Doses)+Cohort2|Part B participants exposed to sarilumab 150 mg q2w or 200 mg q2w or placebo q2w, without adequate response from Week 16, rescued with high dose of sarilumab (SAR 200 mg q2w) (mean exposure of 49 weeks from beginning of randomization to the end of rescue treatment).
372658|NCT01061736|E12|Reported Event|Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)|Part B participants exposed to placebo q2w on top of MTX (mean exposure of 40 weeks). 168 participants with inadequate response from Week 16 rescued with high dose of sarilumab (SAR 200 mg q2w) were not included. Excluded 1 participant randomized to placebo q2w who received sarilumab 200 mg q2w in error. He/she was considered in the 200 mg q2w treatment group for safety analysis.
372659|NCT01061736|E11|Reported Event|Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)|Part B participants exposed to sarilumab 200 mg q2w on top of MTX (mean exposure of 42 weeks). 55 participants with inadequate response from Week 16 rescued with high dose of sarilumab (SAR 200 mg q2w) were not included. Excluded 3 participants randomized to sarilumab 200 mg q2w who received at least one dose of sarilumab 150 mg q2w in error and included a participant randomized to placebo q2w who received sarilumab 200 mg q2w in error.
372660|NCT01061736|E10|Reported Event|Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2)|Part B participants exposed to sarilumab 150 mg q2w on top of MTX (mean exposure of 42 weeks). 61 participants with inadequate response from Week 16 rescued with high dose of sarilumab (SAR 200 mg q2w) were not included. Included 3 participants randomized to sarilumab 200 mg q2w who received at least one dose of sarilumab 150 mg q2w in error.
372661|NCT01061736|E9|Reported Event|Part B: SAR 100 mg q2w Cohort 1 (Non-selected Dose)|Part B participants exposed to sarilumab 100 mg q2w on top of MTX (mean exposure of 13 weeks). Included 1 participant who received sarilumab 100 mg q2w in error.
372662|NCT01061736|E8|Reported Event|Part B: SAR 150 mg qw Cohort 1 (Non-selected Dose)|Part B participants exposed to sarilumab 150 mg qw on top of MTX (mean exposure of 12 weeks). Excluded 1 participant who received sarilumab 100 mg q2w in error. He/she was considered in the 100 mg q2w treatment group for safety analysis.
372663|NCT01061736|E7|Reported Event|Part B: SAR 100 mg qw Cohort 1 (Non-selected Dose)|Part B participants exposed to sarilumab 100 mg qw on top of MTX (mean exposure of 10 weeks).
372664|NCT01061736|E6|Reported Event|Part A: Placebo qw|Part A participants exposed to placebo on top of MTX (mean exposure of 12 weeks). Excluded 1 participant who received an erroneous IMP kit with sarilumab 150 mg q2w. He/she was considered in the 150 mg q2w treatment group for safety analysis.
372665|NCT01061736|E5|Reported Event|Part A: SAR 200 mg q2w|Part A participants exposed to sarilumab 200 mg q2w on top of MTX (mean exposure of 11 weeks).
372666|NCT01061736|E4|Reported Event|Part A: SAR 150 mg q2w|Part A participants exposed to sarilumab 150 mg q2w on top of MTX (mean exposure of 12 weeks). Included the participant randomized to placebo qw who received sarilumab 150 mg q2w in error.
372667|NCT01061736|E3|Reported Event|Part A: SAR 100 mg q2w|Part A participants exposed to sarilumab 100 mg q2w on top of MTX (mean exposure of 11 weeks).
372668|NCT01061736|E2|Reported Event|Part A: SAR 150 mg qw|Part A participants exposed to sarilumab 150 mg qw on top of MTX (mean exposure of 12 weeks).
372669|NCT01061736|E1|Reported Event|Part A: SAR 100 mg qw|Part A participants exposed to sarilumab 100 mg qw on top of MTX (mean exposure of 10 weeks).
372670|NCT01061723|B7|Baseline|Total|Total of all reporting groups
372671|NCT01061723|B6|Baseline|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
372672|NCT01061723|B5|Baseline|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
372673|NCT01061723|B4|Baseline|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
372674|NCT01061723|B3|Baseline|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
372675|NCT01061723|B2|Baseline|Sarilumab 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
372676|NCT01061723|B1|Baseline|Placebo|Placebo (for sarilumab) qw for 12 weeks.
372677|NCT01061723|P6|Participant Flow|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
372678|NCT01061723|P5|Participant Flow|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
372679|NCT01061723|P4|Participant Flow|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
372680|NCT01061723|P3|Participant Flow|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
372681|NCT01061723|P2|Participant Flow|Sarilumab 100 mg q2w|Sarilumab 100 mg subcutaneous (SC) injection alternating with placebo q2w for 12 weeks.
372682|NCT01061723|P1|Participant Flow|Placebo|Placebo (for sarilumab) qw for 12 weeks.
372683|NCT01061723|O6|Outcome|Sarilumab 150mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
372684|NCT01061723|O5|Outcome|Sarilumab 200mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
372685|NCT01061723|O4|Outcome|Sarilumab 100mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
372686|NCT01061723|O3|Outcome|Sarilumab 150mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
372687|NCT01061723|O2|Outcome|Sarilumab 100mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
372688|NCT01061723|O1|Outcome|Placebo|Placebo (for sarilumab) qw for 12 weeks.
372689|NCT01061723|O6|Outcome|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
372690|NCT01061723|O5|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
372691|NCT01061723|O4|Outcome|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
372692|NCT01061723|O3|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
372693|NCT01061723|O2|Outcome|Sarilumab 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
372694|NCT01061723|O1|Outcome|Placebo|Placebo (for sarilumab) qw for 12 weeks.
372695|NCT01061723|O6|Outcome|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
372696|NCT01061723|O5|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
372697|NCT01061723|O4|Outcome|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
372698|NCT01061723|O3|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
372699|NCT01061723|O2|Outcome|Sarilumab 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
372700|NCT01061723|O1|Outcome|Placebo|Placebo (for sarilumab) qw for 12 weeks.
372701|NCT01061723|O6|Outcome|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
372702|NCT01061723|O5|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
372703|NCT01061723|O4|Outcome|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
372704|NCT01061723|O3|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
372705|NCT01061723|O2|Outcome|Sarilumab 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
372706|NCT01061723|O1|Outcome|Placebo|Placebo (for sarilumab) qw for 12 weeks.
372707|NCT01061723|O6|Outcome|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
372708|NCT01061723|O5|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
372709|NCT01061723|O4|Outcome|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
372710|NCT01061723|O3|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
372711|NCT01061723|O2|Outcome|Sarilumab 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
372712|NCT01061723|O1|Outcome|Placebo|Placebo (for sarilumab) qw for 12 weeks.
372713|NCT01061723|O6|Outcome|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
372714|NCT01061723|O5|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
372715|NCT01061723|O4|Outcome|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
372716|NCT01061723|O3|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
372717|NCT01061723|O2|Outcome|Sarilumab 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
372718|NCT01061723|O1|Outcome|Placebo|Placebo (for sarilumab) qw for 12 weeks.
372719|NCT01061723|O6|Outcome|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
372720|NCT01061723|O5|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
372721|NCT01061723|O4|Outcome|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
372722|NCT01061723|O3|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
372723|NCT01061723|O2|Outcome|Sarilumab 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
372724|NCT01061723|O1|Outcome|Placebo|Placebo (for sarilumab) qw for 12 weeks.
372725|NCT01061723|O6|Outcome|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
372726|NCT01061723|O5|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
372727|NCT01061723|O4|Outcome|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
372732|NCT01061723|O5|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
372733|NCT01061723|O4|Outcome|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
372734|NCT01061723|O3|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
372735|NCT01061723|O2|Outcome|Sarilumab 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
372736|NCT01061723|O1|Outcome|Placebo|Placebo (for sarilumab) qw for 12 weeks.
372737|NCT01061723|O6|Outcome|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
372738|NCT01061723|O5|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
372739|NCT01061723|O4|Outcome|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
372740|NCT01061723|O3|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
372741|NCT01061723|O2|Outcome|Sarilumab 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
372742|NCT01061723|O1|Outcome|Placebo|Placebo (for sarilumab) qw for 12 weeks.
372743|NCT01061723|O6|Outcome|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
372744|NCT01061723|O5|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
372745|NCT01061723|O4|Outcome|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
372746|NCT01061723|O3|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
372747|NCT01061723|O2|Outcome|Sarilumab 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
372748|NCT01061723|O1|Outcome|Placebo|Placebo (for sarilumab) qw for 12 weeks.
372749|NCT01061723|O6|Outcome|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
372750|NCT01061723|O5|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
372751|NCT01061723|O4|Outcome|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
372752|NCT01061723|O3|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
372753|NCT01061723|O2|Outcome|Sarilumab 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
372754|NCT01061723|O1|Outcome|Placebo|Placebo (for sarilumab) qw for 12 weeks.
372755|NCT01061723|E6|Reported Event|SAR153191 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
372756|NCT01061723|E5|Reported Event|SAR153191 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks. Excluded a participant randomized to sarilumab 200 mg q2w who received sarilumab 150 mg q2w in error.
372757|NCT01061723|E4|Reported Event|SAR153191 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
372758|NCT01061723|E3|Reported Event|SAR153191 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks. Included a participant randomized to sarilumab 200 mg q2w who received sarilumab 150 mg q2w in error.
372759|NCT01061723|E2|Reported Event|SAR153191 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
372760|NCT01061723|E1|Reported Event|Placebo|Placebo (for sarilumab) qw for 12 weeks.
372761|NCT01061710|B1|Baseline|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
372762|NCT01061710|P1|Participant Flow|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
372763|NCT01061710|O1|Outcome|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
372764|NCT01061710|O1|Outcome|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
372765|NCT01061710|O1|Outcome|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
372766|NCT01061710|O1|Outcome|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
372767|NCT01061710|O1|Outcome|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
372768|NCT01061710|E1|Reported Event|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
372769|NCT01061671|B3|Baseline|Total|Total of all reporting groups
372770|NCT01061671|B2|Baseline|Placebo|"Matched placebo pill daily~Placebo: Matched placebo pill daily"
372771|NCT01061671|B1|Baseline|Simvastatin|"40 mgms of simvastatin daily~Simvastatin: 40 mgms of simvastatin daily"
372772|NCT01061671|P2|Participant Flow|Placebo|"Matched placebo pill daily~Placebo: Matched placebo pill daily"
372773|NCT01061671|P1|Participant Flow|Simvastatin|"40 mgms of simvastatin daily~Simvastatin: 40 mgms of simvastatin daily"
372774|NCT01061671|O2|Outcome|Placebo|"Matched placebo pill daily~Placebo: Matched placebo pill daily"
372775|NCT01061671|O1|Outcome|Simvastatin|"40 mgms of simvastatin daily~Simvastatin: 40 mgms of simvastatin daily"
372776|NCT01061671|O2|Outcome|Placebo|"Matched placebo pill daily~Placebo: Matched placebo pill daily"
372777|NCT01061671|O1|Outcome|Simvastatin|"40 mgms of simvastatin daily~Simvastatin: 40 mgms of simvastatin daily"
372778|NCT01061671|O2|Outcome|Placebo|"Matched placebo pill daily~Placebo: Matched placebo pill daily"
372779|NCT01061671|O1|Outcome|Simvastatin|"40 mgms of simvastatin daily~Simvastatin: 40 mgms of simvastatin daily"
372780|NCT01061671|O2|Outcome|Placebo|"Matched placebo pill daily~Placebo: Matched placebo pill daily"
372781|NCT01061671|O1|Outcome|Simvastatin|"40 mgms of simvastatin daily~Simvastatin: 40 mgms of simvastatin daily"
372782|NCT01061671|E2|Reported Event|Placebo|"Matched placebo pill daily~Placebo: Matched placebo pill daily"
372783|NCT01061671|E1|Reported Event|Simvastatin|"40 mgms of simvastatin daily~Simvastatin: 40 mgms of simvastatin daily"
372784|NCT01061606|B1|Baseline|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
372785|NCT01061606|P1|Participant Flow|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
372786|NCT01061606|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
372787|NCT01061606|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
372788|NCT01061606|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
372789|NCT01061606|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
372790|NCT01061606|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
372791|NCT01061606|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
372792|NCT01061606|E1|Reported Event|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
372793|NCT01061567|B1|Baseline|All Patients|Patients with Parkinson’s disease in routine clinical practice.
372794|NCT01061567|P1|Participant Flow|All Patients|Patients with Parkinson’s disease in routine clinical practice.
372795|NCT01061567|O1|Outcome|All Patients|Patients with Parkinson’s disease in routine clinical practice.
372796|NCT01061567|O1|Outcome|All Patients|Patients with Parkinson’s disease in routine clinical practice.
372797|NCT01061567|O1|Outcome|All Patients|Patients with Parkinson’s disease in routine clinical practice.
372798|NCT01061567|O1|Outcome|All Patients|Patients with Parkinson’s disease in routine clinical practice.
372799|NCT01061567|O1|Outcome|All Patients|Patients with Parkinson’s disease in routine clinical practice.
372800|NCT01061567|O1|Outcome|All Patients|Patients with Parkinson’s disease in routine clinical practice.
372801|NCT01061567|E1|Reported Event|All Patients|Patients with Parkinson’s disease in routine clinical practice.
372802|NCT01061476|B1|Baseline|Single Arm - Sleep Apnea|"All participants will undergo 3 sleep studies - one off treatment, one on treatment, and one night to assess the physiological effects of the device on breathing during sleep.~Provent™ : Provent™ is an expiratory nasal resistance device applied to the nares via adhesive."
372803|NCT01061476|P1|Participant Flow|Single Arm - Sleep Apnea|"All participants will undergo 3 sleep studies - one off treatment, one on treatment, and one night to assess the physiological effects of the device on breathing during sleep.~Provent™ : Provent™ is an expiratory nasal resistance device applied to the nares via adhesive."
372804|NCT01061476|O1|Outcome|Single Arm - Sleep Apnea|"Each participant had 3 sleep studies. Sleep Study #1 - the patient did not have the Provent™ device on to assess baseline sleep apnea severity. On sleep study #2 - the patient used the Provent™ device to re-assess changes in sleep apnea severity. On sleep study #3, the patient used Provent™ for assessment of the physiological effects of the device on breathing during sleep.~Participants did not use Provent™ outside of the sleep laboratory.~Provent™ : Provent™ is an expiratory nasal resistance device applied to the nares via adhesive."
372805|NCT01061476|E1|Reported Event|Single Arm - Sleep Apnea|"All participants will undergo 3 sleep studies - one off treatment, one on treatment, and one night to assess the physiological effects of the device on breathing during sleep.~Provent™ : Provent™ is an expiratory nasal resistance device applied to the nares via adhesive."
372806|NCT01061385|B3|Baseline|Total|Total of all reporting groups
372807|NCT01061385|B2|Baseline|Control Arm|"Patients presenting for weight loss using behaviour modification (diet and exercise) alone.~Behavioral modification: Diet and exercise"
372808|NCT01061385|B1|Baseline|ReShape Intragastric Balloon|"Patients receiving the ReShape Intragastric Balloon~ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks"
372809|NCT01061385|P2|Participant Flow|Control Arm|"Patients presenting for weight loss using behaviour modification (diet and exercise) alone.~Behavioral modification: Diet and exercise"
372810|NCT01061385|P1|Participant Flow|ReShape Intragastric Balloon|"Patients receiving the ReShape Intragastric Balloon~ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks"
372811|NCT01061385|O2|Outcome|Control Arm|"Patients presenting for weight loss using behaviour modification (diet and exercise) alone.~Behavioral modification: Diet and exercise"
372812|NCT01061385|O1|Outcome|ReShape Intragastric Balloon|"Patients receiving the ReShape Intragastric Balloon~ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks"
372813|NCT01061385|O2|Outcome|Control|Control subjects receiving diet and exercise counseling only
372814|NCT01061385|O1|Outcome|ReShape Intragastric Balloon|"Patients receiving the ReShape Intragastric Balloon~ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks"
372815|NCT01061385|E2|Reported Event|Control Arm|"Patients presenting for weight loss using behaviour modification (diet and exercise) alone.~Behavioral modification: Diet and exercise"
372816|NCT01061385|E1|Reported Event|ReShape Intragastric Balloon|"Patients receiving the ReShape Intragastric Balloon~ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks"
372817|NCT01061359|B1|Baseline|Entire Study Population|Includes all groups enrolled in the study
372818|NCT01061359|P1|Participant Flow|Entire Study Population|Includes all groups enrolled in the study
372819|NCT01061359|O1|Outcome|Epirubicin|Includes groups enrolled to receive all treatments of epirubicin
372820|NCT01061359|O1|Outcome|Epirubicin|Includes groups enrolled to receive all treatments of epirubicin
372821|NCT01061359|O1|Outcome|Epirubicin|Includes groups enrolled to receive all treatments of epirubicin
372822|NCT01061359|E1|Reported Event|Epirubicin|Includes groups enrolled to receive all treatments of epirubicin
372823|NCT01061333|B1|Baseline|All Participants|Over the course of four 3-day treatment regimens, participants received a single dose of each drug starting with placebo, nedocromil or montelukast, nedocromil or montelukast, ending with mometasone; with a 20-day washout between each of the four treatment periods.
372824|NCT01061333|P2|Participant Flow|Placebo-Nedocromil-Montelukast-Mometasone|Over the course of four 3-day treatment regimens, participants received a single dose of each drug starting with placebo, crossover of nedocromil or montelukast, crossover of nedocromil or montelukast, ending with mometasone; with a 20-day washout between each of the four treatment periods.
372825|NCT01061333|P1|Participant Flow|Placebo-Montelukast-Nedocromil-Mometasone|Over the course of four 3-day treatment regimens, participants received a single dose of each drug starting with placebo, crossover of nedocromil or montelukast, crossover of nedocromil or montelukast, ending with mometasone; with a 20-day washout between each of the four treatment periods.
372826|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
372827|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
372828|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
372829|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
372830|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
372831|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
372832|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
372833|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
372834|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
372835|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
372836|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
372837|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
372838|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
372839|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
372840|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
372841|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
372842|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
372843|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
372844|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
372845|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
372846|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
372847|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
372848|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
372849|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
372850|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
372851|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
372852|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
372853|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, Montelukast placebo tablet, Mometasone placebo twisthaler
372854|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
372855|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
372856|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
372857|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
372858|NCT01061333|E4|Reported Event|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
372859|NCT01061333|E3|Reported Event|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
372860|NCT01061333|E2|Reported Event|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
372861|NCT01061333|E1|Reported Event|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
372862|NCT01061177|B1|Baseline|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
372863|NCT01061177|P1|Participant Flow|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
372864|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
372865|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
372866|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
372867|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
372868|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
372869|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
372870|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
372871|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
372872|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
372873|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
372874|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
372875|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
372876|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
372877|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
372878|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
372879|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
372880|NCT01061177|E1|Reported Event|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
372881|NCT01061151|B5|Baseline|Total|Total of all reporting groups
372882|NCT01061151|B4|Baseline|Late Presenters|Registrational component to assess entry criteria for possible randomization in the Postpartum Component
372883|NCT01061151|B3|Baseline|Antepartum Arm C|Mothers received Triple ARV (FTC-TDF/LPV-RTV)
372884|NCT01061151|B2|Baseline|Antepartum Arm B|Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
372885|NCT01061151|B1|Baseline|Antepartum Arm A|Mothers received ZDV+sdNVP+TRV tail
372886|NCT01061151|P4|Participant Flow|Late Presenters|Registrational component to assess entry criteria for possible randomization in the Postpartum Component
372887|NCT01061151|P3|Participant Flow|Antepartum Arm C|Mothers received Triple ARV (FTC-TDF/LPV-RTV)
372888|NCT01061151|P2|Participant Flow|Antepartum Arm B|Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
372889|NCT01061151|P1|Participant Flow|Antepartum Arm A|Mothers received ZDV+sdNVP+TRV tail
372890|NCT01061151|O2|Outcome|Maternal Health Arm B (Discontinue Triple ARVs)|Mothers discontinued triple ARV regimen.
372891|NCT01061151|O1|Outcome|Maternal Health Arm A (Continue Triple ARVs)|Mothers continued receiving triple ARV regimen [preferred regimen: TRV + LPV-RTV].
372892|NCT01061151|O2|Outcome|Maternal Health Arm B (Discontinue Triple ARVs)|Mothers discontinued triple ARV regimen.
372893|NCT01061151|O1|Outcome|Maternal Health Arm A (Continue Triple ARVs)|Mothers continued receiving triple ARV regimen [preferred regimen: TRV + LPV-RTV].
372894|NCT01061151|O2|Outcome|Maternal Health Arm B (Discontinue Triple ARVs)|Mothers discontinued triple ARV regimen.
372895|NCT01061151|O1|Outcome|Maternal Health Arm A (Continue Triple ARVs)|Mothers continued receiving triple ARV regimen [preferred regimen: TRV + LPV-RTV].
372896|NCT01061151|O2|Outcome|Maternal Health Arm B (Discontinue Triple ARVs)|Mothers discontinued triple ARV regimen.
372897|NCT01061151|O1|Outcome|Maternal Health Arm A (Continue Triple ARVs)|Mothers continued receiving triple ARV regimen [preferred regimen: TRV + LPV-RTV].
372898|NCT01061151|O2|Outcome|Maternal Health Arm B (Discontinue Triple ARVs)|Mothers discontinued triple ARV regimen.
372899|NCT01061151|O1|Outcome|Maternal Health Arm A (Continue Triple ARVs)|Mothers continued receiving triple ARV regimen [preferred regimen: TRV + LPV-RTV].
372900|NCT01061151|O2|Outcome|Maternal Health Arm B (Discontinue Triple ARVs)|Mothers discontinued triple ARV regimen.
372901|NCT01061151|O1|Outcome|Maternal Health Arm A (Continue Triple ARVs)|Mothers continued receiving triple ARV regimen [preferred regimen: TRV + LPV-RTV].
372902|NCT01061151|O2|Outcome|Maternal Health Arm B (Discontinue Triple ARVs)|Mothers discontinued triple ARV regimen.
372903|NCT01061151|O1|Outcome|Maternal Health Arm A (Continue Triple ARVs)|Mothers continued receiving triple ARV regimen [preferred regimen: TRV + LPV-RTV].
372904|NCT01061151|O2|Outcome|Postpartum Arm B (Infant Prophylaxis)|Infants received extended NVP.
372905|NCT01061151|O1|Outcome|Postpartum Arm A (Maternal Prophylaxis)|Mothers received prophylaxis [preferred regimen: TRV + LPV-RTV]. Infants received short-course NVP.
372906|NCT01061151|O2|Outcome|Postpartum Arm B (Infant Prophylaxis)|Infants received extended NVP.
372907|NCT01061151|O1|Outcome|Postpartum Arm A (Maternal Prophylaxis)|Mothers received prophylaxis [preferred regimen: TRV + LPV-RTV]. Infants received short-course NVP.
372908|NCT01061151|O3|Outcome|Antepartum Arm C|Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
372909|NCT01061151|O2|Outcome|Antepartum Arm B|Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
372910|NCT01061151|O1|Outcome|Antepartum Arm A|Mothers Received ZDV+sdNVP+TRV Tail
372911|NCT01061151|O3|Outcome|Antepartum Arm C|Mothers received Triple ARV (FTC-TDF/LPV-RTV)
372912|NCT01061151|O2|Outcome|Antepartum Arm B|Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
372913|NCT01061151|O1|Outcome|Antepartum Arm A|Mothers received ZDV+sdNVP+TRV Tail
372914|NCT01061151|O2|Outcome|Maternal Health Arm B (Discontinue Triple ARVs)|Mothers discontinued triple ARV regimen.
372915|NCT01061151|O1|Outcome|Maternal Health Arm A (Continue Triple ARVs)|Mothers continued receiving triple ARV regimen [preferred regimen: TRV + LPV-RTV].
372916|NCT01061151|O2|Outcome|Postpartum Arm B (Infant Prophylaxis)|Infants received extended NVP.
372917|NCT01061151|O1|Outcome|Postpartum Arm A (Maternal Prophylaxis)|Mothers received prophylaxis [preferred regimen: TRV + LPV-RTV]. Infants received short-course NVP.
372918|NCT01061151|O2|Outcome|Postpartum Arm B (Infant Prophylaxis)|Infants received extended NVP.
372919|NCT01061151|O1|Outcome|Postpartum Arm A (Maternal Prophylaxis)|Mothers received prophylaxis [preferred regimen: TRV + LPV-RTV]. Infants received short-course NVP.
372920|NCT01061151|O3|Outcome|Antepartum Arm C|Mothers received Triple ARV (FTC-TDF/LPV-RTV)
372921|NCT01061151|O2|Outcome|Antepartum Arm B|Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
372922|NCT01061151|O1|Outcome|Antepartum Arm A|Mothers received ZDV+sdNVP+TRV Tail
372923|NCT01061151|O3|Outcome|Antepartum Arm C|Mothers received Triple ARV (FTC-TDF/LPV-RTV)
372924|NCT01061151|O2|Outcome|Antepartum Arm B|Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
372925|NCT01061151|O1|Outcome|Antepartum Arm A|Mothers received ZDV+sdNVP+TRV Tail
372926|NCT01061151|O3|Outcome|Antepartum Arm C|Mothers received Triple ARV (FTC-TDF/LPV-RTV)
372927|NCT01061151|O2|Outcome|Antepartum Arm B|Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
372928|NCT01061151|O1|Outcome|Antepartum Arm A|Mothers received ZDV+sdNVP+TRV Tail
372929|NCT01061151|O3|Outcome|Antepartum Arm C|Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
372930|NCT01061151|O2|Outcome|Antepartum Arm B|Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
372931|NCT01061151|O1|Outcome|Antepartum Arm A|Mothers Received ZDV+sdNVP+TRV Tail
372932|NCT01061151|E8|Reported Event|Infant, LP|Registrational component to assess entry criteria for possible randomization in the Postpartum Component
372933|NCT01061151|E7|Reported Event|Infant, (Mother Received Triple ARV (FTC-TDF/LPV-RTV))|Mothers received Triple ARV (FTC-TDF/LPV-RTV)
372934|NCT01061151|E6|Reported Event|Infant, (Mother Received Triple ARV (3TC-ZDV/LPV-RTV))|Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
372935|NCT01061151|E5|Reported Event|Infant, (Mother Received ZDV+sdNVP+TRV Tail)|Mothers received ZDV+sdNVP+TRV tail
372936|NCT01061151|E4|Reported Event|Mother, LP|Registrational component to assess entry criteria for possible randomization in the Postpartum Component
372937|NCT01061151|E3|Reported Event|Mother, (AP) Triple ARV (FTC-TDF/LPV-RTV)|Mothers received Triple ARV (FTC-TDF/LPV-RTV)
372938|NCT01061151|E2|Reported Event|Mother, (AP) Triple ARV (3TC-ZDV/LPV-RTV)|Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
372939|NCT01061151|E1|Reported Event|Mother, (AP) ZDV+sdNVP+TRV Tail|Mothers received ZDV+sdNVP+TRV tail
372940|NCT01061034|B1|Baseline|Aspirin Then Aspirin Plus Omeprazole|7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
372941|NCT01061034|P1|Participant Flow|Aspirin Then Aspirin Plus Omeprazole|7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
372942|NCT01061034|O1|Outcome|Aspirin Then Aspirin Plus Omeprazole|7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
372943|NCT01061034|O1|Outcome|Aspirin Then Aspirin Plus Omeprazole|7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
372944|NCT01061034|E1|Reported Event|Aspirin Then Aspirin Plus Omeprazole|7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
372945|NCT01061008|B3|Baseline|Total|Total of all reporting groups
372946|NCT01061008|B2|Baseline|Treatment as Usual|
372947|NCT01061008|B1|Baseline|Handgrip Exercise|Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program
372948|NCT01061008|P2|Participant Flow|Treatment as Usual|
372949|NCT01061008|P1|Participant Flow|Handgrip Exercise|Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program
372950|NCT01061008|O2|Outcome|Treatment as Usual|
372951|NCT01061008|O1|Outcome|Handgrip Exercise|Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program
372952|NCT01061008|E2|Reported Event|Treatment as Usual|
373332|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
372953|NCT01061008|E1|Reported Event|Handgrip Exercise|Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program
372954|NCT01060670|B3|Baseline|Total|Total of all reporting groups
372955|NCT01060670|B2|Baseline|Control Treatment|Control Treatment consisted of moist wound therapy and was comprised of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing and a gauze wrap and, an offloading/protective device
372956|NCT01060670|B1|Baseline|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing and a gauze wrap and, an offloading/protective device were to be used in conjunction with the IDRT.
372957|NCT01060670|P2|Participant Flow|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
372958|NCT01060670|P1|Participant Flow|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
372959|NCT01060670|O2|Outcome|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
372960|NCT01060670|O1|Outcome|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
372961|NCT01060670|O2|Outcome|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
372962|NCT01060670|O1|Outcome|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
372963|NCT01060670|O2|Outcome|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
372964|NCT01060670|O1|Outcome|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
372965|NCT01060670|O2|Outcome|Moist Wound Therapy|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
372966|NCT01060670|O1|Outcome|Dermal Replacement Device|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
372967|NCT01060670|O2|Outcome|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
372968|NCT01060670|O1|Outcome|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
372969|NCT01060670|O2|Outcome|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
372970|NCT01060670|O1|Outcome|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
372971|NCT01060670|O2|Outcome|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
372972|NCT01060670|O1|Outcome|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
372973|NCT01060670|E2|Reported Event|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
372974|NCT01060670|E1|Reported Event|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
372975|NCT01060592|B3|Baseline|Total|Total of all reporting groups
372976|NCT01060592|B2|Baseline|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
372977|NCT01060592|B1|Baseline|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
372978|NCT01060592|P2|Participant Flow|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
372979|NCT01060592|P1|Participant Flow|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
373627|NCT01059760|O1|Outcome|Baseline Value|
373628|NCT01059760|O3|Outcome|Change When Fed|
372980|NCT01060592|O2|Outcome|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
372981|NCT01060592|O1|Outcome|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
372982|NCT01060592|O2|Outcome|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
372983|NCT01060592|O1|Outcome|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
372984|NCT01060592|O2|Outcome|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
372985|NCT01060592|O1|Outcome|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
372986|NCT01060592|O2|Outcome|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
372987|NCT01060592|O1|Outcome|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
372988|NCT01060592|O2|Outcome|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
372989|NCT01060592|O1|Outcome|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
372990|NCT01060592|E2|Reported Event|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
372991|NCT01060592|E1|Reported Event|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
372992|NCT01060553|B1|Baseline|Arm 1|24 semi-individualized acupuncture treatments over 12 weeks. The front treat-ment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
372993|NCT01060553|P2|Participant Flow|Wait List Control|this group was originall randomly assigned to a wait list control. due to severe recruitment and retention problems, data was collected in those willing to be treated after the wait list. this treatment data is combined with the original treatment group. this group received the same treatment, namely The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue. The front treatment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
372994|NCT01060553|P1|Participant Flow|Active Treatment|"The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue. The front treatment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen~Acupuncture treatment: Traditional Chinese theory explains acupuncture as a technique for balancing the flow of energy - believed to flow through pathways (meridians) in your body. Acupuncture involves the insertion of extremely thin, stainless steel, sterile needles in subcutaneous tissue or muscle at strategic points on your body which correspond to the acupuncture meridians. The Traditional Chinese Medicine (TCM) interview also includes looking at the tongue and feeling the pulse before deciding on all the points to be used."
372995|NCT01060553|O1|Outcome|Arm 1|"The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue. The front treatment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen~Acupuncture treatment: Traditional Chinese theory explains acupuncture as a technique for balancing the flow of energy - believed to flow through pathways (meridians) in your body. Acupuncture involves the insertion of extremely thin, stainless steel, sterile needles in subcutaneous tissue or muscle at strategic points on your body which correspond to the acupuncture meridians. The Traditional Chinese Medicine (TCM) interview also includes looking at the tongue and feeling the pulse before deciding on all the points to be used."
372996|NCT01060553|O1|Outcome|Arm 1|"The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue (tolerance due to frequent use). The front treat-ment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen~Acupuncture treatment: This project was initially designed as a randomized trial with one group receiving treatment and the other wait list control, with delayed treatment. Due to extremely high dropout and cancellations and failure to return for post assessment, a midpoint assessment was added. Analysis was done on pre and post measures of all subjects who completed at least the midpoint assessment"
372997|NCT01060553|E1|Reported Event|Arm 1|The treatment program will consist of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue (tolerance due to frequent use). The front treat-ment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
372998|NCT01060540|B3|Baseline|Total|Total of all reporting groups
372999|NCT01060540|B2|Baseline|CR+EYE|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling
373000|NCT01060540|B1|Baseline|CR+G|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes
373001|NCT01060540|P2|Participant Flow|CR+EYE|"conventional risk counseling for type 2 diabetes (lifetime risk, fasting plasma glucose, and family history)~eye disease counseling"
373002|NCT01060540|P1|Participant Flow|CR+G|"conventional risk counseling for type 2 diabetes (lifetime risk, fasting plasma glucose, and family history)~results of genetic testing for type 2 diabetes based on the genes TCF7L2, PPARG, or KCNJ11"
373003|NCT01060540|O2|Outcome|CR+EYE|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling
373004|NCT01060540|O1|Outcome|CR+G|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes
373005|NCT01060540|O2|Outcome|CR+EYE|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus control eye disease counseling~Conventional risk counseling for type 2 diabetes: Conventional risk counseling: lifetime risk, fasting plasma glucose results, and family history."
373006|NCT01060540|O1|Outcome|CR+G|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing~genetic testing for type 2 diabetes: TCF7L2, PPARG, or KCNJ11"
373007|NCT01060540|O2|Outcome|CR+EYE|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus control eye disease counseling~Conventional risk counseling for type 2 diabetes: Conventional risk counseling: lifetime risk, fasting plasma glucose results, and family history."
373008|NCT01060540|O1|Outcome|CR+G|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing~genetic testing for type 2 diabetes: TCF7L2, PPARG, or KCNJ11"
373009|NCT01060540|O2|Outcome|CR+EYE|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus control eye disease counseling~Conventional risk counseling for type 2 diabetes: Conventional risk counseling: lifetime risk, fasting plasma glucose results, and family history."
373010|NCT01060540|O1|Outcome|CR+G|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing~genetic testing for type 2 diabetes: TCF7L2, PPARG, or KCNJ11"
373011|NCT01060540|O2|Outcome|CR+EYE|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus control eye disease counseling~Conventional risk counseling for type 2 diabetes: Conventional risk counseling: lifetime risk, fasting plasma glucose results, and family history."
373012|NCT01060540|O1|Outcome|CR+G|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing~genetic testing for type 2 diabetes: TCF7L2, PPARG, or KCNJ11"
373013|NCT01060540|E2|Reported Event|CR+EYE|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling
373014|NCT01060540|E1|Reported Event|CR+G|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes
373015|NCT01060150|B1|Baseline|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
373016|NCT01060150|P1|Participant Flow|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
373017|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
373018|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
373019|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
373020|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
373021|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
373022|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
373023|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
373629|NCT01059760|O2|Outcome|Change While Fasting|
373630|NCT01059760|O1|Outcome|Baseline Value|
373024|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
373025|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
373026|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
373027|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
373028|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
373029|NCT01060150|E1|Reported Event|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
373030|NCT01060124|B1|Baseline|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
373031|NCT01060124|P1|Participant Flow|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
373032|NCT01060124|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
373033|NCT01060124|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
373034|NCT01060124|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
373035|NCT01060124|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
373036|NCT01060124|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
373037|NCT01060124|E1|Reported Event|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
373038|NCT01060111|B4|Baseline|Total|Total of all reporting groups
373039|NCT01060111|B3|Baseline|Topiramate Slow and Propranolol Booster|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg was administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
373040|NCT01060111|B2|Baseline|Topiramate Slow|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
373041|NCT01060111|B1|Baseline|Topiramate Standard|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
373042|NCT01060111|P3|Participant Flow|Topiramate Slow and Propranolol Booster|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg was administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
373043|NCT01060111|P2|Participant Flow|Topiramate Slow|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
373044|NCT01060111|P1|Participant Flow|Topiramate Standard|Topiramate 25 milligram (mg) was administered once daily and the dose was increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
373333|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373045|NCT01060111|O3|Outcome|Topiramate Slow and Propranolol Booster|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every 2 Weeks till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
373046|NCT01060111|O2|Outcome|Topiramate Slow|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every 2 Weeks till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion.
373047|NCT01060111|O1|Outcome|Topiramate Standard|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every Week till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion.
373048|NCT01060111|O3|Outcome|Topiramate Slow and Propranolol Booster|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every 2 Weeks till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
373049|NCT01060111|O2|Outcome|Topiramate Slow|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every 2 Weeks till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion.
373050|NCT01060111|O1|Outcome|Topiramate Standard|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every Week till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion.
373051|NCT01060111|O3|Outcome|Topiramate Slow and Propranolol Booster|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every 2 Weeks till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
373052|NCT01060111|O2|Outcome|Topiramate Slow|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every 2 Weeks till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion.
373053|NCT01060111|O1|Outcome|Topiramate Standard|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every Week till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion.
373054|NCT01060111|O3|Outcome|Topiramate Slow and Propranolol Booster|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg was administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
373055|NCT01060111|O2|Outcome|Topiramate Slow|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
373056|NCT01060111|O1|Outcome|Topiramate Standard|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
373057|NCT01060111|E3|Reported Event|Topiramate Slow and Propranolol Booster|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg was administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
373058|NCT01060111|E2|Reported Event|Topiramate Slow|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
373059|NCT01060111|E1|Reported Event|Topiramate Standard|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
373060|NCT01060072|B3|Baseline|Total|Total of all reporting groups
373061|NCT01060072|B2|Baseline|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
373062|NCT01060072|B1|Baseline|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
373063|NCT01060072|P2|Participant Flow|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
373064|NCT01060072|P1|Participant Flow|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
373065|NCT01060072|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
373066|NCT01060072|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
373067|NCT01060072|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
373068|NCT01060072|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
373069|NCT01060072|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
373070|NCT01060072|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
373071|NCT01060072|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
373072|NCT01060072|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
373073|NCT01060072|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
373074|NCT01060072|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
373075|NCT01060072|E2|Reported Event|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
373076|NCT01060072|E1|Reported Event|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
373077|NCT01060059|B3|Baseline|Total|Total of all reporting groups
373334|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373078|NCT01060059|B2|Baseline|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
373079|NCT01060059|B1|Baseline|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
373080|NCT01060059|P2|Participant Flow|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
373081|NCT01060059|P1|Participant Flow|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
373082|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
373083|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
373084|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
373085|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
373086|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
373087|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
373088|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
373089|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
373090|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
373091|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
373092|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
373093|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
373094|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
373095|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
373096|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
373097|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
373098|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
373590|NCT01059760|O2|Outcome|Change While Fasting|
373591|NCT01059760|O1|Outcome|Baseline Value|
373099|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
373100|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
373101|NCT01060059|O1|Outcome|